,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342846,Impact of Intermittent Mass Testing and Treatment on Incidence of Malaria Infection in a High Transmission Area of Western Kenya.,"Progress with malaria control in western Kenya has stagnated since 2007. Additional interventions to reduce the high burden of malaria in this region are urgently needed. We conducted a two-arm, community-based, cluster-randomized, controlled trial of active case detection and treatment of malaria infections in all residents mass testing and treatment (MTaT) of 10 village clusters (intervention clusters) for two consecutive years to measure differences in the incidence of clinical malaria disease and malaria infections compared with 20 control clusters where MTaT was not implemented. All residents of intervention clusters, irrespective of history of fever or other malaria-related symptoms, were tested three times per year before the peak malaria season using malaria rapid diagnostic tests. All positive cases were treated with dihydroartemisinin-piperaquine. The incidence of clinical malaria was measured through passive surveillance, whereas the cumulative incidence of malaria infection was measured using active surveillance in a cohort comprising randomly selected residents. The incidence of clinical malaria was 0.19 cases/person-year (p-y, 95% CI: 0.13-0.28) in the intervention arm and 0.24 cases/p-y (95% CI: 0.15-0.39) in the control arm (incidence rate ratio [IRR] 0.79, 95% CI: 0.61-1.02). The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04). Six rounds of MTaT over 2 years did not have a significant impact on the incidence of clinical malaria or the cumulative incidence of malaria infection in this area of high malaria transmission.",2020,"The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04).","['All residents of intervention clusters, irrespective of history of fever or other malaria-related symptoms', 'in a High Transmission Area of Western Kenya']",['dihydroartemisinin-piperaquine'],"['incidence of clinical malaria or the cumulative incidence of malaria infection', 'incidence rate ratio [IRR', 'Incidence of Malaria Infection', 'incidence of clinical malaria', 'cumulative incidence of malaria infection', 'cumulative incidence of malaria infections', 'incidence of clinical malaria disease and malaria infections']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.204021,"The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04).","[{'ForeName': 'Meghna R', 'Initials': 'MR', 'LastName': 'Desai', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Samuels', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Wycliffe', 'Initials': 'W', 'LastName': 'Odongo', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Nobert Awino', 'Initials': 'NA', 'LastName': 'Odero', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Kephas', 'Initials': 'K', 'LastName': 'Otieno', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Ya Ping', 'Initials': 'YP', 'LastName': 'Shi', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Stephen Patrick', 'Initials': 'SP', 'LastName': 'Kachur', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Hamel', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Lindblade', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0735']
1,32342848,Safety and Immunogenicity of an AS03 B -Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study.,"Dengue disease and its causative agents, the dengue viruses (DENV-1-4), cause high morbidity in tropical and subtropical regions. We evaluated three dosing regimens of the investigational tetravalent AS03 B -adjuvanted dengue-purified inactivated vaccine (DPIV+AS03 B ). In this phase 1/2, observer-blind, placebo-controlled study (NCT02421367), 140 healthy adults were randomized 1:1:2 to receive DPIV+AS03 B  according to the following regimens: 0-1 month (M), 0-1-6 M, or 0-3 M. Participants received DPIV+AS03 B  or placebo at M0, M1, M3, and M6 according to their dosing schedule. Primary objectives were 1) to evaluate the safety of DPIV+AS03 B  for 28 days (D) after each dose; 2) to demonstrate the added value of a booster dose (0-1-6 M versus 0-1 M) based on neutralizing antibody titers to each DENV type (DENV-1-4) at 28 D after the last dose; and, if this objective was met, 3) to demonstrate the benefit of a longer interval between the first and second doses (0-1 M versus 0-3 M). Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV+AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV+AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups. Within 28 D following each dose, the frequency of unsolicited AEs after DPIV+AS03 B  appeared higher for three-dose (0-1-6 M) than two-dose (0-1 M and 0-3 M) regimens. No serious AEs were considered related to vaccination, and no potential immune-mediated diseases were reported during the study. All three schedules were well tolerated. Both primary immunogenicity objectives were demonstrated. The 0-3 M and 0-1-6 M regimens were more immunogenic than the 0-1 M regimen.",2020,"Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV + AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV + AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups.","['140 healthy adults', 'Healthy U.S. Adults']","['adjuvanted dengue-purified inactivated vaccine (DPIV + AS03 B ', 'DPIV + AS03', 'investigational tetravalent AS03 B', 'AS03 B -Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine', 'DPIV + AS03 B  or placebo at M0, M1, M3, and M6 according to their dosing schedule', 'placebo']","['safety of DPIV + AS03 B  for 28 days (D', 'Adverse events (AEs', 'tolerated', 'Safety and Immunogenicity']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0011315', 'cui_str': 'Dengue virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",140.0,0.149575,"Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV + AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV + AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups.","[{'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lepine', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'McArthur', 'Affiliation': 'Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Currier', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moris', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Keiser', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Paris', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GSK, Rockville, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0738']
2,32343000,Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome.,"BACKGROUND


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


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


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


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


FMT provided only a transient relief of symptoms, although it induced a sustained alteration in the microbiota of IBS patients. Therefore, FMT delivered by a single infusion via colonoscopy cannot be recommended as a treatment for IBS in clinical practice. ClinicalTrials.Org, Trial registration number: NCT03561519.",2020,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","['irritable bowel syndrome', 'Forty-nine', 'IBS patients', 'Irritable bowel syndrome (IBS']","['FMT', 'faecal microbiota transplantation versus autologous placebo', 'faecal microbiota transplantation (FMT', 'autologous or allogenic FMT via colonoscopy']","['sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score', 'microbial composition', 'number of patients achieving clinical response', 'IBS symptoms', 'stool water content', 'levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight', 'depression score', 'mean IBS Symptom Severity Score']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",49.0,0.164282,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","[{'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Lahtinen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Jalanka', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hartikainen', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Mattila', 'Affiliation': 'Department of Infectious Diseases, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Hillilä', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Punkkinen', 'Affiliation': 'Department of Gastroenterology, Porvoo Hospital, Porvoo, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Koskenpato', 'Affiliation': 'Department of Gastroenterology, Aava Medical Centre, Helsinki, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Tillonen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Satokari', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Arkkila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15740']
3,32339664,"Effect of prefrontal tDCS on resting brain fMRI graph measures in Alcohol Use Disorders: A randomized, double-blind, sham-controlled study.","OBJECTIVES


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


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


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


The present study adds further support to the increasing evidence base for the clinical utility of tDCS in AUDs. Importantly, we observed improvement in both whole-brain network efficiency as well as inter-regional connectivity within a specific local prefrontal sub-network that is relevant to the neurobiology of AUDs. Replication and extension of these promising leads from the present study can facilitate clinical translation of tDCS, given its advantages (i.e. safety, cost-effectiveness, administration ease with potential for remotely-supervised / home-based application) for treating patients with AUDs.",2020,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","['subjects with AUDs', 'Patients with AUD as per DSM-5 criteria', 'Alcohol Use Disorders', '21 patients (verum/sham\u202f=\u202f11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions']","['prefrontal tDCS', 'Transcranial Direct Current Stimulation (tDCS', 'verum-tDCS (n\u202f=\u202f12) or sham-tDCS']","['resting brain fMRI graph measures', 'likelihood of relapse', 'global efficiency of brain networks', 'functional connectivity of a specific sub-network involving prefrontal regions']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.15234,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","[{'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Holla', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Jitendriya', 'Initials': 'J', 'LastName': 'Biswal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Venkataram', 'Initials': 'V', 'LastName': 'Shivakumar', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Neuroimaging and Interventional Radiology, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Benegal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India. Electronic address: gvs@nimhans.ac.in.'}, {'ForeName': 'Prabhat Kumar', 'Initials': 'PK', 'LastName': 'Chand', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109950']
4,32343190,Age and pre quit-day attrition during smoking cessation treatment.,"The present study aimed to replicate the finding that younger age predicts higher pre quit-day attrition. Our second aim was to explain this relation by examining empirically and theoretically informed age-related risk factors for low smoking cessation treatment engagement. 136 participants ( M   age  = 44.2 years,  SD  = 11.3 years;  age  = 22-64 years) were randomized to 15-weeks of either 1) an exercise intervention ( n  = 72) or 2) a wellness education control condition ( n  = 64). First, a logistic regression analysis was employed to test whether younger adults were more likely than older adults to drop prior to quit date. Next, we assessed whether smoking related health concerns, social expectancies, and/or perceived severity of craving affected the strength of the relation between age and attrition, by adding these three variables to the logistic regression along with age. The logistic regression model indicated that younger age and treatment condition were significantly related to the odds of dropping from treatment prior to the scheduled quit date. Further, health concerns, social expectancies, and/or perceived severity of cravings did not account for the effect of age on pre quit-day attrition. These findings highlight the importance of identifying empirically and theoretically informed variables associated with the pre quit-day attrition problem of young smokers.",2020,The logistic regression model indicated that younger age and treatment condition were significantly related to the odds of dropping from treatment prior to the scheduled quit date.,"['136 participants ( M age \xa0=\xa044.2\xa0years,  SD\xa0 =\xa011.3\xa0years;  age\xa0 =\xa022-64\xa0years']",['exercise intervention ( n  =\xa072) or 2) a wellness education control condition'],"['health concerns, social expectancies, and/or perceived severity of cravings']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",136.0,0.0257536,The logistic regression model indicated that younger age and treatment condition were significantly related to the odds of dropping from treatment prior to the scheduled quit date.,"[{'ForeName': 'Haley E', 'Initials': 'HE', 'LastName': 'Conroy', 'Affiliation': 'Department of Psychology, University of Houston , Houston, TX, USA.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Jacquart', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, University of Texas at Austin , Austin, TX, USA.'}, {'ForeName': 'Scarlett O', 'Initials': 'SO', 'LastName': 'Baird', 'Affiliation': 'Veteran Affairs San Diego Healthcare System , San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University , Dallas, TX, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health, Ltd , San Francisco, CA, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Powers', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, University of Texas at Austin , Austin, TX, USA.'}, {'ForeName': 'Georita M', 'Initials': 'GM', 'LastName': 'Frierson', 'Affiliation': ""School of Arts, Sciences, and Education, D'Youville College , Buffalo, NY, USA.""}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University , Providence, RI, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychology and Department of Psychological and Brain Sciences, Boston University , Boston, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston , Houston, TX, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, University of Texas at Austin , Austin, TX, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1751262']
5,32343081,Muscular morphological adaptations of two whole-body high intensity interval training configurations.,"BACKGROUND


High-intensity intermittent training (HIIT) has increased in popularity due to being time-efficient mode of exercise. Previous HIIT studies have mainly focused on percentage of fat loss, fat mass loss, and weight loss. However, enhancing muscle protein synthesis induced by HIIT that results in muscular morphological adaptations is a potential benefit of HIIT. This study compared the effects of two HIIT protocols on muscular morphological adaptations.
METHODS


Thirty-four recreationally active participants were randomly assigned to 10-5-HIIT and 20-10-HIIT to complete 6 sets of 6 intervals. The 10-5-HIIT and 20-10-HIIT protocols were performed with 10s:5s and 20s:10s exercise-to-rest ratios and provided with 1- and 2-min recovery periods between sets, respectively. Muscle cross-sectional area (mCSA) and echo intensity (EI) of the rectus femoris (RF) and vastus lateralis (VL) were assessed via B-mode ultrasonography before and after intervention. Two-way mixed factorial ANOVAs were used for analyses.
RESULTS


The 10-5-HIIT and 20-10-HIIT groups significantly (P<0.05) increased RF mCSA (change (Δ)=0.4±0.8 cm2, 8.0%; Δ=0.5±0.8 cm2, 5.5%) and VL mCSA (Δ=1.2±1.6 cm2, 9.0%; Δ=2.20±1.4 cm2, 10.4%), respectively. No significant (P>0.05) change was observed for the EI of the RF and VL.
CONCLUSIONS


Whole-body HIIT can be a time-efficient exercise modality to elicit muscular morphological adaptations in the RF and VL muscles. The 10-5-HIIT protocol induced benefits comparable to those of the 20-10-HIIT, while it reduced the total exercise time by 50%.",2020,"The 10-5-HIIT and 20-10-HIIT groups significantly (p < 0.05) increased RF mCSA (change (Δ) = 0.4 ± 0.8 cm2, 8.0%; Δ = 0.5 ± 0.8 cm2, 5.5%) and VL mCSA (Δ = 1.2 ± 1.6 cm2, 9.0%; Δ = 2.20 ± 1.4 cm2, 10.4%), respectively.",['Thirty-four recreationally active participants'],"['two whole-body high intensity interval training (HIIT) configurations', 'High-intensity intermittent training (HIIT']","['Muscle cross-sectional area (mCSA) and echo intensity (EI) of the rectus femoris (RF) and vastus lateralis (VL', 'fat loss, fat mass loss, and weight loss', 'RF mCSA', 'total exercise time']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0429931', 'cui_str': 'Total exercise time'}]",34.0,0.0221676,"The 10-5-HIIT and 20-10-HIIT groups significantly (p < 0.05) increased RF mCSA (change (Δ) = 0.4 ± 0.8 cm2, 8.0%; Δ = 0.5 ± 0.8 cm2, 5.5%) and VL mCSA (Δ = 1.2 ± 1.6 cm2, 9.0%; Δ = 2.20 ± 1.4 cm2, 10.4%), respectively.","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Moghaddam', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA - masoud.moghaddam@okstate.edu.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Estrada', 'Affiliation': 'Aurora University, Aurora, IL, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Baghurst', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': 'Jacobson', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10526-7']
6,32343001,Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper.,"BACKGROUND


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


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


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


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


Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).",2020,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","['Participants underwent 48\xa0h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively', 'Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5\xa0years, males 77.8% and BMI 32.8\xa0kg/m 2  ', 'obese individuals after late-night supper', 'obese participants', 'obese patients with GERD']","['Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid', 'antacid', 'Gaviscon Advance', 'Gaviscon Advance vs antacid', 'Gaviscon Advance vs non-alginate antacid', 'Gaviscon Advance or a non-alginate antacid']","['suppression of % time pH', 'Median pH of the acid pocket', 'symptom frequency and VAS', 'frequency and visual analogue score (VAS) of regurgitation', 'suppression of median pH of acid pocket and lower oesophagus']","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]","[{'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0003138', 'cui_str': 'Antacid'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}]",81.0,0.0540182,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","[{'ForeName': 'Mohd Adli', 'Initials': 'MA', 'LastName': 'Deraman', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Muhammad Ilham', 'Initials': 'MI', 'LastName': 'Abdul Hafidz', 'Affiliation': 'Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh, Malaysia.'}, {'ForeName': 'Rona Marie', 'Initials': 'RM', 'LastName': 'Lawenko', 'Affiliation': 'De La Salle Health Sciences Institute, Dasmarinas, Philippines.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15746']
7,32353906,"The ""11 for Health in Denmark"" intervention in 10- to 12-year-old Danish girls and boys and its effects on well-being-A large-scale cluster RCT.","BACKGROUND


The present study investigates the well-being effects for 10- to 12-year-old children  who participated in the school-based intervention ""11 for Health in Denmark,"" which comprises physical activity (PA) and health education. Subgroup analyses were carried out for boys and girls.
METHOD


Three thousand sixty-one children were randomly assigned to an intervention group (IG) or a control group (CG) by 5:1 cluster randomization by school. 2533 children (mean age 11.5 ± 0.4; 49.7% boys) were assigned to IG and 528 children (mean age 11.4 ± 0.5; 50.8% boys) were assigned to CG. IG participated in the ""11 for Health in Denmark"" 11-week program, consisting of 2 × 45 min per week of football drills, small-sided games, and health education. CG did not participate in any intervention and continued with their regular education. Before and after the intervention period, both groups answered a shortened version of the multidimensional well-being questionnaire KIDSCREEN-27.
RESULTS


The ""11 for Health in Denmark"" intervention program had a positive effect on physical well-being in girls (IG: 48.6 ± 8.5 to 50.2 ± 9.3), whereas the improvement was not significant in boys. The program also had a positive impact on well-being scores for peers and social support (IG: 50.2 ± 10.2 to 50.8 ± 10.1), though when analyzed separately in the subgroups of boys and girls the changes were not significant. No between-group differences were found for psychological well-being or school environment.
CONCLUSION


The intervention program had a positive between-group effect on physical well-being in girls, whereas the change was not significant in boys. The overall scores for peers and social support improved during the intervention period, but no subgroup differences were found.",2020,"The programme also had positive impact on well-being score for peers and social support (IG: 50.2±10.2 to 50.8±10.1), but when analysed separately in the subgroups of boys and girls the changes were not significant.","['2533 children (mean age 11.5±0.4; 49.7% boys) were assigned to IG and 528 children (mean age 11.4±0.5; 50.8% boys', '10-12-year-old children of the school-based intervention ""11 for Health in Denmark"", which comprises physical activity (PA) and health education', 'children', '3061', '10-12-year-old Danish girls and boys']","['intervention group (IG) or a control group (CG', 'CG']","['psychological well-being or school environment', 'overall scores for peers and social support']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",3061.0,0.0329689,"The programme also had positive impact on well-being score for peers and social support (IG: 50.2±10.2 to 50.8±10.1), but when analysed separately in the subgroups of boys and girls the changes were not significant.","[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Madsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Elbe', 'Affiliation': 'Institute of Sport Psychology and Physical Education, Faculty of Sport Science, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Esben Elholm', 'Initials': 'EE', 'LastName': 'Madsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Ermidis', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Ryom', 'Affiliation': 'Department of Public Health, Section of Health Promotion and Global Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Johan Michael', 'Initials': 'JM', 'LastName': 'Wikman', 'Affiliation': 'Centre for Research on Welfare, Health and Sport (CVHI), Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Rasmussen Lind', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Malte Nejst', 'Initials': 'MN', 'LastName': 'Larsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13704']
8,32367124,"High-Intensity Exercise Improves Fatigue, Sleep, and Mood in Patients With Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial.","OBJECTIVE


Although exercise is recommended in the treatment of axial spondyloarthritis (axSpa), the focus has been on flexibility, and the effect of high-intensity exercises is unknown. The purpose of this study was to investigate the effect of high-intensity exercises on fatigue, sleep, and mood in patients with axSpA.
METHODS


In this secondary analysis of a randomized controlled trial, participants were recruited from outpatient clinics at 4 hospitals in Scandinavia. A total of 100 patients with axSpA were randomized to either an exercise group (n = 50) or a control group (n = 50). High-intensity exercise was provided 3 times per week for 3 months and supervised by a physical therapist. The controls received no intervention. Measurements were self-reported at baseline, 3 months, and 12 months: fatigue, using the Fatigue Severity Scale (range = 0-7, 7 = worst, ≥5 = severe); vitality, using the RAND 36-item short-form health survey (SF-36, range = 0-100, 100 = best); sleep, using the Pittsburgh Sleep Quality Index (range = 0-21, 21 = worst, >5 = poor quality); mood, using the General Health Questionnaire 12 (range = 0-36, 36 = worst); and general health, using the EUROQoL (range = 0-100, 100 = best).
RESULTS


A total of 38 participants (76%) in the exercise group followed ≥80% of the exercise protocol. At 3 months, there was a significant beneficial effect on fatigue (mean group differences = -0.4, 95% CI = -0.7 to -0.1), vitality (5.0, 95% CI = 1.1 to 10.5), mood (-2, 95% CI = -3.7 to -0.04), and general health (9.0, 95% CI = 3.3 to 14.7) but no effect on sleep (-1.1, 95% CI = -2.1 to 0.2). Compared with the control group, the exercise group had a reduced rate of severe fatigue and poor sleep. No differences were seen between the groups at 12 months.
CONCLUSIONS


A 3-month exercise program had a beneficial effect on fatigue, sleep, mood, and general health in patients with axSpA at the end of the intervention; however, no long-term effects were seen.
IMPACT


High-intensity cardiorespiratory and strength exercises should be considered as important in exercise programs for patients with axSpA.",2020,"No differences were seen between the groups at 12 months.
","['One hundred patients with axSpA', 'Patients With Axial Spondyloarthritis', 'patients with axSpA', 'participants were recruited from outpatient clinics at 4 hospitals in Scandinavia']","['High-Intensity Exercise', 'High-intensity exercise', 'high-intensity exercises', 'IMPACT\n\n\nHigh intensity cardiorespiratory and strength exercises', 'exercise group (n\xa0=\xa050) or a control group']","['\xa0worst, ≥5\xa0=\xa0severe); vitality, using the RAND 36-item short-form health survey', 'fatigue', 'fatigue, sleep, mood, and general health', 'Fatigue Severity Scale', 'Fatigue, Sleep, and Mood', 'vitality', 'sleep', 'general health', 'fatigue, sleep, and mood', 'Pittsburgh Sleep Quality Index', 'rate of severe fatigue and poor sleep']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}]",100.0,0.116561,"No differences were seen between the groups at 12 months.
","[{'ForeName': 'Silje Halvorsen', 'Initials': 'SH', 'LastName': 'Sveaas', 'Affiliation': 'Department of Rheumatology, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Diakonveien 12, Oslo, Norway.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Dagfinrud', 'Affiliation': 'Department of Rheumatology, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Inger Jorid', 'Initials': 'IJ', 'LastName': 'Berg', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Sella Arrestad', 'Initials': 'SA', 'LastName': 'Provan', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Melissa Woll', 'Initials': 'MW', 'LastName': 'Johansen', 'Affiliation': 'Department of Physiotherapy, Martina Hansens Hospital, Bærum, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'Department of Physiotherapy, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Bilberg', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Physical therapy,['10.1093/ptj/pzaa086']
9,32354432,"Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial.","INTRODUCTION


The objective of this prospective randomized clinical trial was to investigate the relationship between clear aligner (CA) therapy and the development of white spot lesions and compare it with orthodontic fixed appliance (FA) therapy.
METHODS


This was a prospective randomized clinical trial. The setting was the postgraduate orthodontic clinic at Jordan University of Science and Technology. A total of 49 patients (39 female, 10 male; mean age ± standard deviation, 21.25 ± 3 years) who required orthodontic treatment with either FAs or CAs were randomly allocated into 1 of 2 study groups. Eligibility criteria included healthy patients of both sexes (age range 17-24 years), Class I malocclusion with mild-to-moderate crowding (≤5 mm), nonextraction treatment plan, and optimum oral hygiene before treatment as determined by clinical examination. The participants were randomly assigned to a study group according to a simple randomization method using a coin toss by the patient; the text or tail side of the coin indicated treatment with CA (group 1), and the head side of the coin indicated orthodontic treatment with FA (group 2). Blinding was applicable for outcome assessment only. CA therapy was performed for group 1 and FA for group 2. Quantitative light-induced fluorescence (QLF) images were taken before treatment (T 0 ) and 3 months later (T 1 ). The QLF images were then analyzed to assess the research outcomes. The main outcome was the mean amount of fluorescence loss (ΔF). Number of newly developed lesions, deepest point in the lesion (ΔF Max ), lesion area (pixels), and plaque surface area (ΔR 30 ) were measured as secondary outcomes. Descriptive statistics and comparison within and between groups were calculated.
RESULTS


In total, 42 of the 49 participants recruited completed the study (19 in the CA group and 23 in the FA group). The mean amount of fluorescence loss was 0.4% for the CA group (P = 0.283) and 1.2% for the FA group (P = 0.013). The difference between the 2 groups was significant (confidence interval [CI], -1.8 to -0.4; P = 0.002). The mean increase in lesion area was 82.2 pixels for the CA group (P <0.001) and 9.3 pixels for the FA group (P = 0.225). The difference between the 2 groups was significant (CI, -117 to -75.0; P <0.001). ΔR 30  was 1.2% for the CA group and 10.9% for the FA group (CI, 6.847-12.479; P <0.001). The number of newly developed lesions in the CA group was 6 lesions/patient and 8.25 in the FA group (P = 0.039). No serious harm on the oral health of the participants in the 2 study groups was observed other than mild gingivitis associated with plaque accumulation. No serious harm was reported by any of the participants.
CONCLUSIONS


Orthodontic treatment with CAs and FAs caused enamel demineralization. The CA group developed larger but shallower white spot lesions, whereas the FA group developed more new lesions with greater severity, but they were smaller in area. More plaque accumulation was found in the FA group compared with the CA group.
REGISTRATION


NCT04107012.
PROTOCOL


The protocol was published after trial commencement.",2020,No serious harm on the oral health of the participants in the 2 study groups was observed other than mild gingivitis associated with plaque accumulation.,"['49 patients (39 female, 10 male; mean age\xa0±\xa0standard deviation, 21.25\xa0±\xa03\xa0years) who required orthodontic treatment with either FAs or CAs', 'Eligibility criteria included healthy patients of both sexes (age range 17-24\xa0years', 'In total, 42 of the 49 participants recruited completed the study (19 in the CA group and 23 in the FA group', 'Class I malocclusion with mild-to-moderate crowding (≤5\xa0mm), nonextraction treatment plan, and optimum oral hygiene before treatment as determined by clinical examination']","['CA', 'fixed appliance therapy, evaluated with quantitative light-induced fluorescence', 'CA therapy', 'orthodontic fixed appliance (FA) therapy', 'simple randomization method using a coin toss by the patient; the text or tail side of the coin indicated treatment with CA']","['Enamel demineralization', 'mean amount of fluorescence loss', 'number of newly developed lesions', 'enamel demineralization', 'oral health', 'plaque accumulation', 'Number of newly developed lesions, deepest point in the lesion (ΔF Max ), lesion area (pixels), and plaque surface area (ΔR 30 ', 'mean increase in lesion area', 'Quantitative light-induced fluorescence (QLF) images', 'mean amount of fluorescence loss (ΔF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0399523', 'cui_str': 'Malocclusion, Angle class I'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0851193', 'cui_str': 'Fixed appliance therapy'}, {'cui': 'C4704843', 'cui_str': 'Quantitative Light-Induced Fluorescence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0524669', 'cui_str': 'Coins'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4704843', 'cui_str': 'Quantitative Light-Induced Fluorescence'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",49.0,0.0459931,No serious harm on the oral health of the participants in the 2 study groups was observed other than mild gingivitis associated with plaque accumulation.,"[{'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Albhaisi', 'Affiliation': 'Department of Preventive Dentistry, Division of Orthodontics, School of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Al-Khateeb', 'Affiliation': 'Department of Preventive Dentistry, Division of Orthodontics, School of Dentistry, Jordan University of Science and Technology, Irbid, Jordan. Electronic address: susank@just.edu.jo.'}, {'ForeName': 'Elham S', 'Initials': 'ES', 'LastName': 'Abu Alhaija', 'Affiliation': 'Department of Preventive Dentistry, Division of Orthodontics, School of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.01.004']
10,32342210,Plasma xanthine oxidoreductase (XOR) activity in patients who require cardiovascular intensive care.,"Hyperuricemia is known to be associated with adverse outcomes in cardiovascular intensive care patients, but its mechanisms are unknown. A total of 569 emergency department patients were prospectively analyzed and assigned to intensive care (ICU group, n = 431) or other departments (n = 138). Uric acid (UA) levels were significantly higher in the intensive care patients (6.3 [5.1-7.6] mg/dl vs. 5.8 [4.6-6.8] mg/dL). The plasma xanthine oxidoreductase (XOR) activity in the ICU group (68.3 [21.2-359.5] pmol/h/mL) was also significantly higher than that in other departments (37.2 [15.1-93.6] pmol/h/mL). Intensive care patients were divided into three groups according to plasma XOR quartiles (Q1, low-XOR, Q2/Q3, normal-XOR, and Q4, high-XOR group). A multivariate logistic regression model showed that lactate (per 1.0 mmol/L increase, OR 1.326; 95%, CI 1.166-1.508, p < 0.001) and the Acute Physiology and Chronic Health Evaluation II score (per 1.0 point increase, OR 1.095, 95% CI 1.034-1.160, p = 0.002) were independently associated with the high-XOR group. In-hospital mortality was significantly higher in the high-XOR group (n = 28, 26.2%) than in the normal- (n = 11, 5.1%) and low- (n = 9, 8.3%) XOR groups. The high-XOR group (vs. normal-XOR group) was independently associated with the in-hospital mortality (OR 2.934; 95% CI 1.170-7.358; p = 0.022). Serum UA levels and plasma XOR activity were high in patients admitted to intensive care. The enhanced XOR activity may be one of the mechanisms under which hyperuricemia was associated with adverse outcomes in patients requiring cardiovascular intensive care.",2020,"In-hospital mortality was significantly higher in the high-XOR group (n = 28, 26.2%) than in the normal- (n = 11, 5.1%) and low- (n = 9, 8.3%) XOR groups.","['patients requiring cardiovascular intensive care', 'cardiovascular intensive care patients', 'Intensive care patients', 'patients who require cardiovascular intensive care', 'A total of 569 emergency department patients were prospectively analyzed and assigned to intensive care (ICU group, n\u2009=\u2009431) or other departments (n\u2009=\u2009138']",[],"['Uric acid (UA) levels', 'plasma xanthine oxidoreductase (XOR) activity', 'Acute Physiology and Chronic Health Evaluation II score', 'Plasma xanthine oxidoreductase (XOR) activity', 'hospital mortality', 'enhanced XOR activity', 'Serum UA levels and plasma XOR activity', 'plasma XOR quartiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043316', 'cui_str': 'Xanthine dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}]",569.0,0.0437989,"In-hospital mortality was significantly higher in the high-XOR group (n = 28, 26.2%) than in the normal- (n = 11, 5.1%) and low- (n = 9, 8.3%) XOR groups.","[{'ForeName': 'Yusaku', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shirakabe', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan. s6042@nms.ac.jp.'}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Okazaki', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Matsushita', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Goda', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Shigihara', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Asano', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Kiuchi', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tani', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Takayo', 'Initials': 'T', 'LastName': 'Murase', 'Affiliation': 'Department of Radioisotope and Chemical Analysis Center, Sanwa Kagaku Kenkyusho Co., Ltd, Mie, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department Pharmacological Study Group, Pharmaceutical Research Laboratories, Sanwa Kagaku Kenkyusho Co., Ltd, Mie, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Noritake', 'Initials': 'N', 'LastName': 'Hata', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Kuniya', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Division of Intensive Care Unit, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01608-x']
11,32348280,A Pedometer-Guided Physical Activity Intervention for Obese Pregnant Women (the Fit MUM Study): Randomized Feasibility Study.,"BACKGROUND


Obesity in pregnancy is a growing problem worldwide, with excessive gestational weight gain (GWG) occurring in the majority of pregnancies. This significantly increases risks to both mother and child. A major contributor to both prepregnancy obesity and excessive GWG is physical inactivity; however, past interventions targeting maternal weight gain and activity levels during the antenatal period have been ineffective in women who are already overweight. Pedometer-guided activity may offer a novel solution for increasing activity levels in this population.
OBJECTIVE


This initial feasibility randomized controlled trial aimed to test a pedometer-based intervention to increase activity and reduce excessive GWG in pregnant women.
METHODS


We supplied 30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups: control (pedometer only), app (pedometer synced to patients' personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach-delivered behavioral change program). Feasibility outcomes included participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity. Activity outcomes (step counts and active minutes) were analyzed using linear mixed models and generalized estimating equations.
RESULTS


A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30; 2 withdrawals and 1 stillbirth); 27 participants thus completed the study. Mean BMI in all groups was ≥35 kg/m 2 . Mean (SD) percentage of missing data days were 23.4% (20.6%), 39.5% (32.4%), and 21.1% (16.0%) in control, app group, and app-coach group patients, respectively. Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration. There was a mean decrease of 7.8 steps/day for each increase in gestation day over the study period (95% CI 2.91 to 12.69, P=.002).
CONCLUSIONS


Activity data syncing with a personal smartphone is feasible in a cohort of pregnant women with obesity. However, our results do not support a future definitive study in its present form. Recruitment and retention rates were adequate, as was activity data syncing to participants' smartphones. A follow-up interventional trial seeking to reduce GWG and improve activity in this population must focus on improving compliance with activity data recording and behavioral interventions delivered.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry ACTRN12617000038392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370884.",2020,"Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration.","['pregnant women with obesity', 'women who are already overweight', '30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups', 'Obese Pregnant Women', 'A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30, 2 withdrawals and 1 stillbirth); 27 participants thus completed the study', 'pregnant women']","['pedometer-based intervention', 'Pedometer-Guided Physical Activity Intervention', ""control (pedometer only), app (pedometer synced to patients' personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach-delivered behavioral change program""]","['Estimated mean baseline activity levels', 'Recruitment and retention rates', 'maternal weight gain and activity levels', 'Mean BMI', 'Mean (SD) percentage of missing data days', 'activity levels', 'participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity', 'Activity outcomes (step counts and active minutes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0453984', 'cui_str': 'Zipper'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}]",30.0,0.0752825,"Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration.","[{'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Darvall', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Mohamed Nusry', 'Initials': 'MN', 'LastName': 'Nazeem', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Cheryce L', 'Initials': 'CL', 'LastName': 'Harrison', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiotherapy, Western Health, Melbourne, Australia.'}, {'ForeName': 'Chennelle', 'Initials': 'C', 'LastName': 'Mendoza', 'Affiliation': 'Department of Physiotherapy, Western Health, Melbourne, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harrap', 'Affiliation': 'Melbourne Epicentre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Teale', 'Affiliation': ""Department of Women's and Children's Services, Western Health, Melbourne, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hessian', 'Affiliation': 'Department of Anaesthesia and Pain Management, Western Health, Melbourne, Australia.'}]",JMIR mHealth and uHealth,['10.2196/15112']
12,32346981,Predicting bone and soft tissue alterations of immediate implant sites in the esthetic zone using clinical parameters.,"BACKGROUND


Immediate implantation is generally a predictable treatment, but sometimes there are significant tissue alterations at the surgical site which compromise clinical outcomes.
PURPOSE


This study aimed to investigate the association between tissue alterations and different clinical parameters in esthetic areas following immediate implant placement and provisionalization.
MATERIALS AND METHODS


Clinical parameters were measured at 36 non-grafted immediate implant sites enrolled in a randomized controlled trial. Alterations of bone and soft tissue were measured at 12 months after the treatment. Stepwise linear regression analysis was performed to analyze the association between different clinical parameters and outcomes of interest.
RESULTS


Gingival thickness 3 mm apical to the gingival margin (GT3) was positively associated with recession of mid-buccal gingival margin, while vertical distance between the buccal gingival margin and the crest (GM-bone) was negatively associated (P = .03, .01). Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01). Horizontal defect dimension was positively associated with buccal ridge dimensional reduction while gingival thickness at free gingival margin (GT1) was negatively associated (P = .01, .04). Regarding interproximal bone level change, none of the clinical parameters was significantly associated.
CONCLUSIONS


Gingival phenotype was the only parameter significantly associated with both buccal gingival recession and buccal ridge dimensional reduction. It is important to assess clinical parameters before and during immediate implant procedure.",2020,"Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01).",['Clinical parameters were measured at 36 non-grafted immediate implant sites enrolled in a randomized controlled trial'],['immediate implant placement and provisionalization'],"['Gingival thickness 3\u2009mm apical to the gingival margin (GT3', 'buccal gingival recession and buccal ridge dimensional reduction', 'Gingival phenotype', 'Flap elevation and older age', 'Alterations of bone and soft tissue', 'buccal ridge dimensional reduction while gingival thickness at free gingival margin (GT1']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",36.0,0.0323287,"Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01).","[{'ForeName': 'Chun-Teh', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontics and Dental Hygiene, The University of Texas Health Science Center School of Dentistry, Houston, Texas, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sanz-Miralles', 'Affiliation': 'Division of Periodontics, Section of Oral and Diagnostic Sciences, Columbia University College of Dental Medicine, New York, New York, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Biostatistics & Epidemiology Research Design Core, Center for Clinical and Translational Sciences, Department of Internal Medicine, Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Glick', 'Affiliation': 'Private practice, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': ""Department of Pediatric and Special Needs Dentistry, Arkansas Children's Hospital, Little Rock, Arkansas, USA.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Stoupel', 'Affiliation': 'Private practice, New York, New York, USA.'}]",Clinical implant dentistry and related research,['10.1111/cid.12910']
13,32348263,Effect of an mHealth Intervention Using a Pedometer App With Full In-Person Counseling on Body Composition of Overweight Adults: Randomized Controlled Weight Loss Trial.,"BACKGROUND


In clinical practice, it is difficult to convey the benefits of sustained physical activity to adult patients with excess weight or obesity. For this purpose, a goal-setting walking prescription may be an effective strategy.
OBJECTIVE


This study aimed to determine the efficacy of the intervention of a pedometer app in setting a goal to reach 10,000 steps per day in adults.
METHODS


Overweight adults (n=98; mean body mass index 32.53 [SD 4.92] kg/m2) were randomized to one of two conditions (control or intervention). Both groups downloaded a pedometer app that recorded their daily step counts and were given a daily walking goal of 10,000 steps. Subjects participated in a 24-week in-person behavioral weight control program and were asked to monitor their daily levels using the pedometer app. Baseline data were recorded and followed up weekly. Only the intervention group had structured information delivery, a personalized physical activity prescription, and follow-up on number of steps per day.
RESULTS


The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized β coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
CONCLUSIONS


These results could have implications for improving self-monitoring in overweight adults during periods of weight loss. Health professionals should analyze the implementation of tools that permit them to prescribe, follow up, and encourage the achievement of a goal of physical activity in overweight or obese patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03845478; https://clinicaltrials.gov/ct2/show/NCT03845478.",2020,"The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized beta coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
","['Overweight Adults', 'Overweight adults (n=98; mean body mass index 32.53 [SD 4.92] kg/m2', 'adults', 'overweight or obese patients', 'adult patients with excess weight or obesity']",['mHealth Intervention Using a Pedometer App With Full'],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]",[],,0.0631852,"The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized beta coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Hernández-Reyes', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cámara-Martos', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Molina-Luque', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Moreno-Rojas', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}]",JMIR mHealth and uHealth,['10.2196/16999']
14,32358836,Cost-effectiveness evaluation of the PROPPR trial transfusion protocols.,"BACKGROUND


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


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


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


The 1:1:1 transfusion ratio in severely injured hemorrhaging trauma patients is a very cost-effective strategy for increasing hemostasis and decreasing trauma deaths.",2020,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"['severely injured hemorrhaging trauma patients', '680 subjects', 'International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights']",[],"['hemostasis', 'overall costs', 'hemorrhagic death', 'total hospital cost', 'life expectancy']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",680.0,0.0809202,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"[{'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Callcut', 'Affiliation': 'Division of General Surgery, Department of Surgery, School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'Department of Healthcare Leadership & Management, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baraniuk', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': 'Center for Translational Injury Research and Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15784']
15,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
16,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
17,32343882,Association of High Serum Interleukin-6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis.,"OBJECTIVE


The development of biomarkers to guide treatment decisions is a major research focus in rheumatoid arthritis (RA). Patients with RA have elevated interleukin-6 (IL-6) levels; however, the utility of IL-6 as a predictor of treatment response is unclear. This study was undertaken to investigate, by post hoc analysis, whether baseline IL-6 levels are predictive of sarilumab treatment responses in 2 phase III studies.
METHODS


Serum IL-6 concentrations were measured in patients with RA prior to receiving sarilumab 200 mg (n = 148) or adalimumab 40 mg (n = 152) every 2 weeks (in the MONARCH trial; ClinicalTrials.gov identifier: NCT02332590) or sarilumab 150 mg, sarilumab 200 mg, or placebo every 2 weeks plus methotrexate (MTX) (n = 401, n = 396, and n = 397, respectively) (in the MOBILITY trial; ClinicalTrials.gov identifier: NCT01061736). Efficacy and patient-reported outcomes were compared between and within groups according to IL-6 tertile using linear and logistic regression.
RESULTS


In MONARCH, patients with high baseline IL-6 levels (all ≥3 times the upper limit of normal; n = 100) had higher disease activity at baseline than those with low IL-6 levels (n = 100). The magnitude of clinical improvement over 24 weeks with sarilumab versus adalimumab was greater in patients with high compared to those with low baseline IL-6 levels. In MOBILITY, compared to patients with low IL-6 levels (n = 397), patients with high IL-6 levels (n = 398) had higher disease activity and joint damage at baseline, were more likely to have joint progression, and had less clinical improvement over 52 weeks' treatment with placebo plus MTX compared to sarilumab 150 mg or 200 mg plus MTX. Baseline IL-6 and C-reactive protein levels were both predictive of outcomes. Safety profiles were similar between defined IL-6 tertiles.
CONCLUSION


IL-6 may be a prognostic marker of disease progression and severity, and patients with high IL-6 levels may be likely to benefit from sarilumab compared to adalimumab or MTX. Prospective validation is warranted to confirm the results of these post hoc analyses.",2020,The magnitude of clinical improvement over 24 weeks with sarilumab versus adalimumab was greater in patients with high baseline IL-6 than patients with low baseline IL-6.,"['patients with RA prior to receiving sarilumab 200 mg (n = 148) or', 'patients with high IL-6 (n = 398']","['adalimumab', 'adalimumab or methotrexate', 'placebo+methotrexate', 'Adalimumab or Methotrexate', 'sarilumab 150 or 200 mg+methotrexate']","['elevated interleukin-6 (IL-6) levels', 'Baseline IL-6 and C-reactive protein', 'disease activity', 'Safety profiles', 'disease activity and joint damage', 'Serum IL-6 concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.184548,The magnitude of clinical improvement over 24 weeks with sarilumab versus adalimumab was greater in patients with high baseline IL-6 than patients with low baseline IL-6.,"[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Boyapati', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Schwartzman', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Msihid', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Stanford University Medical Center, Palo Alto, California.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Lam', 'Affiliation': 'Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sadeh', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41299']
18,32343890,Olaparib for Metastatic Castration-Resistant Prostate Cancer.,"BACKGROUND


Multiple loss-of-function alterations in genes that are involved in DNA repair, including homologous recombination repair, are associated with response to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition in patients with prostate and other cancers.
METHODS


We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone). All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair. Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue. Patients were randomly assigned (in a 2:1 ratio) to receive olaparib or the physician's choice of enzalutamide or abiraterone (control). The primary end point was imaging-based progression-free survival in cohort A according to blinded independent central review.
RESULTS


In cohort A, imaging-based progression-free survival was significantly longer in the olaparib group than in the control group (median, 7.4 months vs. 3.6 months; hazard ratio for progression or death, 0.34; 95% confidence interval, 0.25 to 0.47; P<0.001); a significant benefit was also observed with respect to the confirmed objective response rate and the time to pain progression. The median overall survival in cohort A was 18.5 months in the olaparib group and 15.1 months in the control group; 81% of the patients in the control group who had progression crossed over to receive olaparib. A significant benefit for olaparib was also seen for imaging-based progression-free survival in the overall population (cohorts A and B). Anemia and nausea were the main toxic effects in patients who received olaparib.
CONCLUSIONS


In men with metastatic castration-resistant prostate cancer who had disease progression while receiving enzalutamide or abiraterone and who had alterations in genes with a role in homologous recombination repair, olaparib was associated with longer progression-free survival and better measures of response and patient-reported end points than either enzalutamide or abiraterone. (Funded by AstraZeneca and Merck Sharp & Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).",2020,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"['Cohort A (245 patients) had at least one alteration in  BRCA1 ,  BRCA2 , or  ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone', 'patients with prostate and other cancers', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving', 'Metastatic Castration-Resistant Prostate Cancer']","['PARP inhibitor olaparib', 'enzalutamide or abiraterone', ""olaparib or the physician's choice of enzalutamide or abiraterone (control"", 'Olaparib']","['objective response rate and the time to pain progression', 'Anemia and nausea', 'median overall survival', 'imaging-based progression-free survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",245.0,0.264475,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"[{'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Burgents', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Adelman', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa1911440']
19,32343960,"JNJ-56136379, an HBV Capsid Assembly Modulator, Is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients With Chronic Infection.","BACKGROUND & AIMS


JNJ-56136379 (JNJ-6379), a capsid assembly modulator that blocks hepatitis B virus (HBV) replication, was well tolerated and demonstrated dose-proportional pharmacokinetics in healthy participants in part 1 of its first clinical trial. In part 2, we have evaluated the safety, pharmacokinetics, and antiviral activity of multiple doses of JNJ-6379 in patients with chronic HBV infection.
METHODS


We performed a double-blind study of 57 treatment-naïve patients with HB e antigen-positive or -negative (74%) chronic HBV infection without cirrhosis. Patients were randomly assigned to groups given JNJ-6379 at 25 mg (100 mg loading dose), 75 mg, 150 mg, or 250 mg or placebo daily for 4 weeks with an 8-week follow-up period.
RESULTS


Twenty-three (56%) of 41 patients given JNJ-6379 had at least 1 adverse event (AE) during treatment, compared with 10 (63%) of 16 patients given placebo. No serious AEs were reported during the treatment period. Three patients (7%) given JNJ-6379 vs none given placebo had grade 3 AEs; of these, 1 patient (150 mg) also had an isolated grade 4 increase in the level of alanine aminotransferase that led to treatment discontinuation. JNJ-6379 exposure increased with dose, with time-linear pharmacokinetics. HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status. On day 29, 13 (32%) of 41 patients had levels of HBV DNA below the lower limit of quantification. No clinically significant changes in levels of HB surface antigen were observed.
CONCLUSIONS


In a phase 1 study of treatment-naïve patients with chronic HBV infection, all doses tested of JNJ-6379 were well tolerated, showed dose-dependent pharmacokinetics, and had potent antiviral activity in patients with CHB. The findings support a phase 2a study to evaluate JNJ-6379 ± nucleos(t)ide analogs in patients with chronic HBV infection, which is under way. ClinicalTrials.gov identifier: NCT02662712.",2020,"HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status.","['Patients with Chronic Infection', 'patients with CHB', 'patients with chronic HBV infection', 'healthy participants', '57 treatment-naïve patients with HB e antigen-positive or -negative (74%) chronic HBV infection without cirrhosis']","['JNJ-6379', 'placebo']","['levels of HBV DNA', 'level of alanine aminotransferase', 'HBV-DNA and HBV-RNA', 'safety, pharmacokinetics, and antiviral activity', 'levels of HB surface antigen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151317', 'cui_str': 'Chronic infectious disease'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003339', 'cui_str': 'Surface Antigens'}]",,0.0672743,"HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status.","[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Zoulim', 'Affiliation': 'Hepatology Unit, Hospices Civils de Lyon and Lyon University, Lyon, France; INSERM U1052-Cancer Research Institute of Lyon, Lyon, France. Electronic address: fabien.zoulim@chu-lyon.fr.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Lenz', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Joris J', 'Initials': 'JJ', 'LastName': 'Vandenbossche', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Talloen', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Verbinnen', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Iurie', 'Initials': 'I', 'LastName': 'Moscalu', 'Affiliation': 'Spitalul Clinic Republican, ARENSIA EM, Chișinău, Moldova.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Streinu-Cercel', 'Affiliation': 'National Institute for Infectious Diseases ""Prof. Dr Matei Bals"", Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bourgeois', 'Affiliation': 'ZNA Jan Palfijn, CPU, Antwerp, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Hospital Universitario Vall d'Hebrón and CIBERHED del Instituto Carlos III, Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Crespo', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, IDIVAL Santander, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Manuel Pascasio', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Seville, Spain.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Sarrazin', 'Affiliation': 'Medizinische Klinik II, St. Josefs-Hospital, Weisbaden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanwolleghem', 'Affiliation': 'Erasmus MC, University Medical Center, Rotterdam, Netherlands; Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Janssen Pharmaceuticals R&D, Titusville, New Jersey. Electronic address: UShukla@its.jnj.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fry', 'Affiliation': 'Janssen Biopharma Inc., South San Francisco, California.'}, {'ForeName': 'Jeysen Z', 'Initials': 'JZ', 'LastName': 'Yogaratnam', 'Affiliation': 'Janssen Biopharma Inc., South San Francisco, California.'}]",Gastroenterology,['10.1053/j.gastro.2020.04.036']
20,32343967,Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers.,"BACKGROUND


Peak inspiratory flow (PIF) has been proposed as a measure to assess a patient's ability to use dry powder inhalers (DPIs). However, robust quality criteria to determine a repeatability limit for measuring PIF are lacking.
RESEARCH QUESTIONS


What are the repeatability limits for measuring PIF? What is the relationship between PIF measured using the In-Check DIAL device at Diskus (GlaxoSmithKline; PIF D ) and HandiHaler (Boehringer Ingelheim; PIF HH ) resistances?
STUDY DESIGN AND METHODS


Data from a randomized, controlled, phase 3 trial (study 0149; see Clinical Trial Registration data) were used to define repeatability limits for PIF. In addition, a model to characterize the relationship between PIF measured with the In-Check DIAL device at PIF D  and PIF HH  was defined using data from two randomized, controlled, phase 3 trials (studies 0128 and 0149).
RESULTS


In study 0128, the mean values (SD) for PIF at zero resistance and PIF HH  were 84.6 (33.4) and 57.3 (26.1) L/min, respectively. In study 0149, the mean values (SD) for PIF D  and PIF HH  were 42.4 (11.2) and 29.0 (8.3) L/min, respectively. At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 and < 3 L/min, respectively. The repeatability limit was determined as 10 and 5 L/min for PIF D  and PIF HH , respectively. Modeling the relationship between PIF D  and PIF HH , after controlling for significant covariates, demonstrated that a PIF D  value of 60 L/min was approximately equivalent to PIF HH  of 40 L/min.
INTERPRETATIONS


This analysis demonstrated that the two highest values of PIF using the In-Check DIAL device among three inspiratory efforts, met the repeatability limit. Altogether, these data provide guidance for measuring PIF against the simulated resistance of a specific DPI in clinical practice and research studies.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; Nos.: NCT02518139 (study 0128) and NCT03095456 (study 0149); URL: www.clinicaltrials.gov.",2020,"At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 L/min and < 3 L/min, respectively.",[],['Peak inspiratory flow (PIF'],"['repeatability limit', 'mean values (standard deviation [SD]) for PIF at zero resistance and PIF HH', 'mean values (SD) for PIF D  and PIF HH', 'PIF D  and PIF HH']",[],"[{'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0420994,"At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 L/min and < 3 L/min, respectively.","[{'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Mahler', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Ohar', 'Affiliation': 'Wake Forest University Medical Center, Winston-Salem, NC.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lombardi', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Crater', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA. Electronic address: gcrater@theravance.com.'}]",Chest,['10.1016/j.chest.2020.03.072']
21,32352250,Loteprednol etabonate gel 0.5% vs prednisolone acetate suspension 1% for the treatment of inflammation after cataract surgery in children.,"PURPOSE


To compare loteprednol etabonate (LE) gel 0.5% with prednisolone acetate suspension (PA) 1% for the treatment of inflammation after cataract surgery in children.
SETTING


Eleven sites in the United States.
DESIGN


Randomized, double-masked, parallel-group, noninferiority study.
METHODS


Eligible patients were aged 11 years or younger and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week postsurgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, anterior chamber inflammation (ACI), synechiae, precipitates on the intraocular lens/cornea, visual acuity, and intraocular pressure.
RESULTS


The intent-to-treat population comprised 105 patients (LE gel, n = 53; PA 1%, n = 52) including 52 patients aged 3 years or younger. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI, -0.281 to 0.292). Similar ACI outcomes additionally were observed in patients aged 3 years or younger. LE gel 0.5% and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, and 28 postsurgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P ≥ .06). Synechiae and corneal/IOL precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases.
CONCLUSIONS


LE gel 0.5% was safe and effective in treating pediatric postcataract surgical inflammation, with similar outcomes as PA 1%.",2020,"LE gel and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, 28 post-surgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P≥0.06).","['Eleven sites in the United States', '52 patients aged ≤3 years', 'Eligible patients were ≤11 years of age and candidates for routine, uncomplicated cataract surgery', 'patients ≤3 years of age', 'inflammation after cataract surgery in children']","['Loteprednol etabonate gel', 'loteprednol etabonate (LE) gel 0.5% with prednisolone acetate (PA) suspension', 'prednisolone acetate suspension', 'LE gel 0.5% or PA']","['safety or tolerability concerns', 'categorical distributions of ACI, AC cells, and AC flare scores/grades', 'Synechiae and corneal/implant precipitates', 'anterior chamber (AC) cells/flare, AC inflammation (ACI), synechiae, precipitates on the implant/cornea, visual acuity, and intraocular pressure (IOP']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0126177', 'cui_str': 'loteprednol etabonate'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0154933', 'cui_str': 'Adhesions of iris'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",52.0,0.0977674,"LE gel and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, 28 post-surgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P≥0.06).","[{'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Vittitow', 'Affiliation': 'From Clinical Affairs, Bausch + Lomb (Vittitow), Bridgewater, New Jersey, and Clinical Affairs, Bausch + Lomb (Williams), Irvine, California, USA.'}, {'ForeName': 'Jon I', 'Initials': 'JI', 'LastName': 'Williams', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000218']
22,32349134,[Hydrogen sulphide stimuli shorten exhalation during sleep as well as in wakefulness].,"BACKGROUND


In the attentive waking state, pleasant odours often prolong inhalation while unpleasant odours often shorten the exhalation. It should be checked whether this induced breathing pattern is maintained even during sleep.
METHODOLOGY


23 healthy normosmic adults were examined by polysomnography for one night and randomized pulsed either with H 2 S, phenylethyl alcohol (PEA) or CO 2  via a flow olfactometer. The determination of the sleep stages was based on the standard polysomnography curves. From the breathing curves (respiratory nasal pressure breathing, thoracic or abdominal belt breathing) a low-artefact curve was selected and seven breaths were measured from their breathing signal around the trigger impulse. The duration of inspiration (DIN) and the duration of the expiration (DEX) were determined from the six prestimulatory breaths and from breath with the stimulus onset and thus defined a reaction index (RI) indicating whether there is a significant change in shortening or prolonging DIN and/or DEX. These different RI were corrected by the spontaneous baseline RI and analysed according to the type of stimulus and the sleep stages.
RESULTS


Reaction indices with reductions of DEX were larger than spontaneous RI and RI for PEA and H 2 S stimulation. In the case of CO 2  irritation, RI with reductions of DIN and DEX were larger than with olfactory stimulation. All RI were equal in their amount between sleep stages. In REM, the difference between olfactory RI with shortened DEX between H 2 S and PEA stimulation was greatest.
CONCLUSION


When stimulated with an unpleasant smell in sleep, the respiratory reaction pattern from the awake state is preserved. RI with shortened DEX can be considered as an imperfect arousal.",2020,"In the case of CO 2  irritation, RI with reductions of DIN and DEX were larger than with olfactory stimulation.",['23 healthy normosmic adults'],"['DEX', 'RI with shortened DEX', 'polysomnography for one night and randomized pulsed either with H 2 S, phenylethyl alcohol (PEA) or CO 2  via a flow olfactometer', 'Hydrogen sulphide stimuli shorten exhalation']","['duration of inspiration (DIN) and the duration of the expiration (DEX', 'breathing curves (respiratory nasal pressure breathing, thoracic or abdominal belt breathing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0031398', 'cui_str': 'Phenylethyl Alcohol'}, {'cui': 'C0020282', 'cui_str': 'Hydrogen sulfide'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429206', 'cui_str': 'Nasal pressure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0452227', 'cui_str': 'Belt'}]",23.0,0.0153785,"In the case of CO 2  irritation, RI with reductions of DIN and DEX were larger than with olfactory stimulation.","[{'ForeName': 'Hilmar', 'Initials': 'H', 'LastName': 'Gudziol', 'Affiliation': 'Klinik für Hals-, Nasen- und Ohrenheilkunde, Jena\xa0University Hospital, Jena, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Quaas', 'Affiliation': 'Klinik für Hals-, Nasen- und Ohrenheilkunde, Jena\xa0University Hospital, Jena, Germany.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Guntinas-Lichius', 'Affiliation': 'Klinik für Hals-, Nasen- und Ohrenheilkunde, Jena\xa0University Hospital, Jena, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Lehnich', 'Affiliation': 'Medizinische Fakultät ZMG, Martin-Luther-Universität Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bitter', 'Affiliation': 'Klinik für Hals-, Nasen- und Ohrenheilkunde, Jena\xa0University Hospital, Jena, Germany.'}]",Laryngo- rhino- otologie,['10.1055/a-1157-9314']
23,32300012,"Social, psychological, and demographic characteristics of dehumanization toward immigrants.","This study extends the current body of work on dehumanization by evaluating the social, psychological, and demographic correlates of blatant disregard for immigrants. Participants ( n  = 468) were randomly assigned to read a scenario where 1) an immigrant or 2) an immigrant and their child were caught illegally crossing the southern border of the United States, and then rated how long they should spend in jail if convicted. Participants reported that they would sentence the immigrant to more jail time than the immigrant and child. Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers). Crucially, endorsed social harms accounted for explained variance beyond simply holding conservative views. We position these data within the current literature on dehumanization theory and immigration issues.",2020,"Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers).","['Participants ( n  = 468', 'immigrants']",[],['jail time'],"[{'cui': 'C0282163', 'cui_str': 'Immigrant'}]",[],"[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",468.0,0.0240809,"Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Markowitz', 'Affiliation': 'School of Journalism and Communication, University of Oregon, Eugene, OR 97403.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Slovic', 'Affiliation': 'Decision Research, Eugene, OR 97401; pslovic@uoregon.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1921790117']
24,32366273,Correction to: Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['hospitalized smokers'],['post-discharge strategies'],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",[],,0.0526284,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA. nrigotti@partners.org.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Schnitzer', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.'}, {'ForeName': 'Esa M', 'Initials': 'EM', 'LastName': 'Davis', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.'}, {'ForeName': 'Jennifer H K', 'Initials': 'JHK', 'LastName': 'Kelley', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Notier', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gilliam', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Division of General, Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Trials,['10.1186/s13063-020-04356-5']
25,32346816,Agreement Among Paper and Electronic Modes of the EQ-5D-5L.,"INTRODUCTION


While the EQ-5D-5L has been migrated to several electronic modes, evidence supporting the measurement equivalence of the original paper-based instrument to the electronic modes is limited.
OBJECTIVES


This study was designed to comprehensively examine the equivalence of the paper and electronic modes (i.e., handheld, tablet, interactive voice response [IVR], and web).
METHODS


As part of the foundational work for this study, the test-retest reliability of the paper-based, UK English format of the EQ-5D-5L was assessed using a single-group, single-visit, two-period, repeated-measures design. To compare paper and electronic modes, three independent samples were recruited into a three-period crossover study. Each participant was assigned to one of six groups to account for order effects. Descriptive statistics, mean differences (i.e., split-plot analysis of variance [ANOVA]), and intraclass correlation coefficients (ICCs) were calculated.
RESULTS


The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores. For the electronic comparisons, mean difference confidence intervals (CIs) for the EQ-5D index scores and EQ VAS scores reflected equivalence of the means across all modes, as the CIs were wholly contained inside the equivalence interval. Further, the ICC 95% lower CIs for the index and EQ VAS scores showed values above the thresholds for denoting equivalence across all comparisons in each sample. No significant mode-by-order interactions were present in any ANOVA model.
CONCLUSIONS


Overall, our comparisons of the paper, screen-based, and phone-based formats of the EQ-5D-5L provided substantial evidence to support the measurement equivalence of these modes of data collection.",2020,The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores.,[],['EQ-5D-5L'],"['intraclass correlation coefficients (ICCs', 'EQ VAS scores', 'EQ-5D index scores and EQ VAS scores']",[],[],"[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.036839,The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores.,"[{'ForeName': 'J Jason', 'Initials': 'JJ', 'LastName': 'Lundy', 'Affiliation': 'Outcometrix, 433 Central Avenue, Suite 300, St. Petersburg, FL, 33701, USA. jlundy@outcometrix.com.'}, {'ForeName': 'Stephen Joel', 'Initials': 'SJ', 'LastName': 'Coons', 'Affiliation': 'Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA.'}, {'ForeName': 'Emuella', 'Initials': 'E', 'LastName': 'Flood', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Mira J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Division of Clinical Outcome Assessment, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, White Oak, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The patient,['10.1007/s40271-020-00419-6']
26,32347414,Predictors of Research Assessment Completion in a Latino Sample with Dual Disorders.,"Latinos are underrepresented in clinical trials, where they encounter challenges in participation and a lack of effective recruitment and retention strategies. For Latino migrants with mental health and substance use problems, these challenges are even greater. Analyzing results from a multicenter randomized clinical trial for Latino migrants with mental health and substance use problems in Boston, Massachusetts, USA as well as Madrid and Barcelona, Spain, we describe six retention strategies used to facilitate participant engagement in follow-up assessments, and report the sociodemographic, clinical, and educational factors associated with research assessment completion. Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments. Having a high school diploma, being recruited at community centers versus other sites, and having a less severe mental health condition were significantly associated with completing more follow-up interviews. Rigorous and customized methods reflecting participant's individual context can bolster research assessment completion for diverse Latino populations with behavioral health concerns.",2020,"Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments.","['Latino Sample with Dual Disorders', 'diverse Latino populations with behavioral health concerns', 'Latino migrants with mental health and substance use problems in Boston, Massachusetts, USA as well as Madrid and Barcelona, Spain']",[],['severe mental health condition'],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",341.0,0.068088,"Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments.","[{'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Herrera', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Sheri Lapatin', 'Initials': 'SL', 'LastName': 'Markle', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Aroca', 'Affiliation': 'Department of Psychiatry, Instituto de Investigación Sanitaria, Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Villar', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Dominique', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Umoren', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Alegría', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA. malegria@mgh.harvard.edu.'}]",Journal of immigrant and minority health,['10.1007/s10903-020-01010-9']
27,32347695,Comparison of clinical outcomes between vector planning and manifest refraction planning in SMILE for myopic astigmatism.,"PURPOSE


To compare clinical outcomes of small-incision lenticule extraction (SMILE) between manifest refraction (MR) and vector planning for myopic astigmatism with high ocular residual astigmatism (ORA).
SETTING


Yonsei University College of Medicine and Eyereum Eye Clinic, Seoul, South Korea.
DESIGN


Prospective, randomized, comparative case series.
METHODS


Patients with myopic astigmatism and ORA of 0.75 diopters (D) or greater were randomized into the MR or vector planning group and underwent SMILE without applying any nomogram for cylinder correction. Visual acuity, MR, corneal topography, and corneal aberration were measured preoperatively and postoperatively. Outcomes at 6 months postoperatively were compared between the groups.
RESULTS


The study comprised 114 patients (114 eyes): 58 eyes in MR planning and 56 eyes in vector planning. The mean uncorrected and corrected distance visual acuity, safety and efficacy indices were comparable between the 2 groups. Postoperative refractive cylinder reached statistically significant differences between the groups (-0.22 ± 0.18 D and -0.14 ± 0.16 D in the MR and vector planning groups, respectively, P = .02). Postoperative corneal toricity and ORA reached statistically significant lower in the vector planning group.
CONCLUSIONS


In myopic astigmatism with high ORA, MR and vector planning in SMILE were effective with comparable visual outcomes; vector planning showed statistically significant lower postoperative refractive and corneal astigmatism and ORA. Use of vector planning may improve refractive outcomes in SMILE cases with high ORA. However, the results may have been different had a nomogram adjustment been applied, as is often used for cylinder corrections with SMILE.",2020,"The mean uncorrected and corrected distance visual acuity, safety and efficacy indices, and aberrometric values were comparable between the two groups at 6 months after SMILE.","[' We included 114 eyes of 114 patients with myopic astigmatism and ORA ≥ 0.75 diopters (D); patients underwent SMILE', 'myopic astigmatism with high ocular residual astigmatism (ORA', 'small incision lenticule extraction for myopic astigmatism', 'SMILE cases with high ORA', 'Yonsei University College of Medicine and Eyereum Eye Clinic, Seoul, Korea DESIGN']","['manifest refraction planning (58 eyes) or vector planning', 'vector planning', 'small incision lenticule extraction (SMILE', 'Vector Planning and manifest refraction planning']","['ORA', 'Postoperative refractive cylinder', 'Postoperative corneal toricity', 'refractive outcomes', 'mean uncorrected and corrected distance visual acuity, safety and efficacy indices, and aberrometric values', 'Visual acuity, manifest refraction, corneal topography, and corneal aberration', 'postoperative refractive and corneal astigmatism, and ORA']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3203722', 'cui_str': 'Residual astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C3203722', 'cui_str': 'Residual astigmatism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}]",114.0,0.0381255,"The mean uncorrected and corrected distance visual acuity, safety and efficacy indices, and aberrometric values were comparable between the two groups at 6 months after SMILE.","[{'ForeName': 'Ikhyun', 'Initials': 'I', 'LastName': 'Jun', 'Affiliation': ""From the Department of Ophthalmology (Jun, E. K. Kim, Seo, Lee, T.-i. Kim), The Institute of Vision Research, Department of Ophthalmology (Jun, E.K. Kim, T.-i. Kim), Corneal Dystrophy Research Institute, Yonsei University College of Medicine, Eyereum Eye Clinic (Kang, Jean), Seoul, South Korea; Research and Development (Arba-Mosquera), Biomedical Engineering Office, SCHWIND eye-tech-solutions, Kleinostheim, Germany; London Vision Clinic (Reinstein, Archer), London, United Kingdom; Department of Ophthalmology (Reinstein), Columbia University Medical Center, New York, NY, USA; Centre Hospitalier National d'Ophtalmologie (Reinstein), Paris, France; Biomedical Science Research Institute, University of Ulster (Reinstein, Archer), Coleraine, Northern Ireland.""}, {'ForeName': 'David Sung Yong', 'Initials': 'DSY', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Arba-Mosquera', 'Affiliation': ''}, {'ForeName': 'Dan Z', 'Initials': 'DZ', 'LastName': 'Reinstein', 'Affiliation': ''}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Archer', 'Affiliation': ''}, {'ForeName': 'Seung Ki', 'Initials': 'SK', 'LastName': 'Jean', 'Affiliation': ''}, {'ForeName': 'Eung Kweon', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kyoung Yul', 'Initials': 'KY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Hyung Keun', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae-Im', 'Initials': 'TI', 'LastName': 'Kim', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000100']
28,32350931,Effect of a tailored home-based exercise program in patients with systemic sclerosis: A randomized controlled trial.,"OBJECTIVE


The aim was to evaluate the effect of a home-based exercise program on functional capacity, health-related quality of life (HRQoL), and disability, in patients with systemic sclerosis (SSc).
METHODS


A 6-month randomized controlled trial was conducted on SSc patients by comparing a home-based minimally supervised exercise program (exercise on a stationary cycle and strengthening of upper limbs; stretching of the hands) with usual care. At baseline and after 3 and 6 months, the patients underwent: 6 minutes walking test; hand mobility in scleroderma test; maximal exercise test on an ergocycle; strength measures (handgrip, quadriceps, and biceps). HRQoL (short-form 36 [SF-36]) and disability (health assessment questionnaire disability index [HAQ-DI]) were measured at the same time.
RESULTS


Forty-four patients participated in the study. Twenty-two were randomly assigned to the intervention group (IG, mean age 63.60 ± 10.40 years) and 22 to the control group (CG, 61.80 ± 14.40 years). At 6 months, the distance walked in 6 minutes increased by 46 m (baseline 486, 95% CI 458-513 m; 6 months 532, 95% CI 504-561 m) in IG, whereas it decreased by 5 m (baseline 464, 95% CI 431-497 m; 6 months 459, 95% CI 427-490 m) in CG with a significantly different temporal trend at the between-groups comparison (P < .001). An improvement was also observed for strength measures (handgrip, P = .003; quadriceps, P < .001; biceps, P < .001), for the SF-36 physical component score (P < .001) and for the HAQ-DI (P = .011).
CONCLUSIONS


This study indicates that in SSc patients, a minimally supervised home-based exercise program improves physical performance, quality of life, and disability in comparison with usual care.",2020,"An improvement was also observed for strength measures (handgrip, p=0.003; quadriceps, p <0.001; biceps, p <0.001), for the SF-36 physical component score (p<0.001) and for the HAQ-DI (p=0.011).
","['Twenty-two were randomly assigned to the intervention group (IG, mean age', 'patients with systemic sclerosis (SSc', 'patients with Systemic Sclerosis', 'SSc patients by comparing a home-based', 'Forty-four patients participated in the study']","['home-based exercise program', 'tailored home-based exercise program', 'minimally supervised exercise program (exercise on a stationary cycle and strengthening of upper limbs; stretching of the hands) with usual care']","['mobility in scleroderma-test (HAMIS-test); maximal exercise test on an ergo-cycle; strength measures (handgrip, quadriceps and biceps', 'functional capacity, health-related quality of life (HRQoL) and disability', 'distance walked in six minutes', 'HRQoL [short form-36 (SF-36)] and disability [health assessment questionnaire disability index (HAQ-DI', 'SF-36 physical component score', 'strength measures', 'physical performance, quality of life and disability']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.147349,"An improvement was also observed for strength measures (handgrip, p=0.003; quadriceps, p <0.001; biceps, p <0.001), for the SF-36 physical component score (p<0.001) and for the HAQ-DI (p=0.011).
","[{'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Cazzoletti', 'Affiliation': 'Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zamboni', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ferrari', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Caimmi', 'Affiliation': 'Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tardivo', 'Affiliation': 'Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13702']
29,32350975,"Onabotulinumtoxin Type A reconstitution with preserved versus preservative-free saline in chronic migraine (B-RECON). A randomised, double-blind trial.","INTRODUCTION


Onabotulinumtoxin type A (BoNTA) is manufactured as powder that requires reconstitution with normal saline prior to injection. Previous literature has suggested that preserved saline (PS) exerts a local anaesthetic effect, and reduces the procedure discomfort when used in reconstitution in lieu of preservative-free saline (PFS). However, this was mainly studied in the aesthetics indications of BoNTA, and never in its use for the treatment of chronic migraine. The distinction is important as chronic migraine population suffers high incidence of scalp allodynia which makes it more prone to injection site pain. In addition, the pain of the procedure itself may be related to the spike of migraine frequency in the immediate postprocedural period which can occur in up to 5% of patients receiving the treatment. Our trial aimed to study the difference in procedural pain scale, and postprocedural headache rating with the use of PS vs PFS in constitution of BoNTA when used as a treatment for chronic migraine.
METHODS


68 subjects were consecutively enrolled in an outpatient setting at a large tertiary headache centre over a period of 6 months. Subjects were randomised into PS or PFS group. BoNTA was administered as per standard protocol in both groups. Injection site pain scores and frequency of headache days in the immediate following week were recorded. Wilcoxon rank sum tests were used to compare differences in between groups using SPSS software.
RESULTS


Analysis (SAS V 9.4) revealed that those receiving [PF] had significantly higher procedure pain scores than those receiving [P] (5.3 vs 3.2, respectively). There was no difference in the headache or migraine frequency in the immediate postprocedural period.
CONCLUSION


This study supports the use of PS (bacteriostatic) over PFS for reconstitution of BoNTA in chronic migraine as it reduces the discomfort of the injection sites.",2020,"There was no difference in the headache or migraine frequency in the immediate post procedural period.
",['68 subjects were consecutively enrolled in an outpatient setting at a large tertiary headache center over a period of 6 months'],"['Onabotulinumtoxin', 'Onabotulinumtoxin Type A reconstitution with preserved versus preservative-free saline', 'preserved saline (bacteriostatic) over preservative-free saline', 'PS or PFS', 'preservative-free saline', 'saline (PS', 'Preserved (bacteriostatic) saline']","['headache or migraine frequency', 'procedure pain scores', 'procedural pain scale, and post-procedural headache rating', 'Injection site pain scores and frequency of headache days']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1696683', 'cui_str': 'Post procedural headache'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0857361', 'cui_str': 'Headache occurring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",68.0,0.0863709,"There was no difference in the headache or migraine frequency in the immediate post procedural period.
","[{'ForeName': 'Awss', 'Initials': 'A', 'LastName': 'Zidan', 'Affiliation': 'Department of Neurology, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Sharmeen', 'Initials': 'S', 'LastName': 'Hussaini', 'Affiliation': 'Department of Neurology, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'Department of Neurology, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Brooks', 'Affiliation': 'Center for Research and Evaluation, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Mejico', 'Affiliation': 'Department of Neurology, SUNY Upstate Medical University, Syracuse, NY, USA.'}]",International journal of clinical practice,['10.1111/ijcp.13522']
30,32353101,The influence of a doppler ultrasound in arteriovenous fistula for dialysis failure related to some risk factors.,"INTRODUCTION


The increasing prevalence of chronic kidney disease has increased the demand for arteriovenous fistula (AVF) care. The objective of this study was to assess the relationship between some risk factors for AVF failure (advanced age, female sex, diabetes, obesity, central venous catheter, previous fistula, and hospitalization) and having a Doppler ultrasound performed preoperatively.
METHODS


A prospective study was performed with 228 dialysis patients from Imperatriz, Maranhão. Half of the sample was randomly selected to receive preoperative Doppler ultrasound and the other half did not, from the period of October 2016 to September 2018.
RESULTS


There were 53 total failures corresponding to 23.2% of our sample, which is almost double that of the patients in the clinical group. Considering the failures and risk factors associated with the overall sample, there was a statistically significant association between a central venous catheter on the same side of the AVF with P = 0.04 (Odds Ratio 1.24) and obesity with P = 0.05 (Odds Ratio 1.36), which was not repeated in the Doppler ultrasound group individually. There was no statistically significant difference between the Doppler group and clinical group with respect to the amount of days of previous AVF hospitalization and failure.
CONCLUSIONS


We concluded that the reduction of failures with an introduction of the Doppler was statistically significant in the overall sample, but establishing a relationship between specific risk factors and failure was only possible with two of the risk factors in the study - obesity and central venous catheter on the same side of the AVF.",2020,"There was no statistically significant difference between the Doppler group and clinical group with respect to the amount of days of previous AVF hospitalization and failure.
","['228 dialysis patients from Imperatriz, Maranhão']","['preoperative Doppler ultrasound', 'doppler ultrasound']",['AVF hospitalization and failure'],"[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}]","[{'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.0189298,"There was no statistically significant difference between the Doppler group and clinical group with respect to the amount of days of previous AVF hospitalization and failure.
","[{'ForeName': 'Jocefábia Reika Alves', 'Initials': 'JRA', 'LastName': 'Lopes', 'Affiliation': 'Faculdade de Medicina do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Ana Lígia de Barros', 'Initials': 'ALB', 'LastName': 'Marques', 'Affiliation': 'Universidade Federal do Maranhão, Imperatriz, MA, Brasil.'}, {'ForeName': 'João Antonio', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Faculdade de Medicina do ABC, Santo André, SP, Brasil.'}]",Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia,['10.1590/2175-8239-JBN-2019-0080']
31,32353419,"Impact of transcranial direct current stimulation on sustained attention in breast cancer survivors: Evidence for feasibility, tolerability, and initial efficacy.","BACKGROUND


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


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


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


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


Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer-related cognitive dysfunction.",2020,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","['survivors with cancer-related cognitive dysfunction', 'breast cancer survivors', '16 breast cancer survivors']","['Transcranial direct current stimulation (tDCS', 'tDCS', 'active tDCS', 'transcranial direct current stimulation']","['feasibility, tolerability, acceptability, and efficacy', 'standard errors of reaction times']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.118383,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Gaynor', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA. Electronic address: gaynora@mskcc.org.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Pergolizzi', 'Affiliation': 'Universitat Internacional de Catalunya, School of Medicine and Health Sciences, Barcelona, Spain.'}, {'ForeName': 'Yesne', 'Initials': 'Y', 'LastName': 'Alici', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Katrazyna', 'Initials': 'K', 'LastName': 'McNeal', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.04.013']
32,32289134,PURL: Can drinking more water prevent urinary tract infections?,A high-quality randomized controlled trial says 'Yes.',2020,A high-quality randomized controlled trial says 'Yes.',[],[],[],[],[],[],,0.07454,A high-quality randomized controlled trial says 'Yes.',"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'McCollum', 'Affiliation': 'Family Medicine Residency, Dwight David Eisenhower Army Medical Center, Fort Gordon, GA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Garigan', 'Affiliation': 'Family Medicine Residency, Dwight David Eisenhower Army Medical Center, Fort Gordon, GA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Earwood', 'Affiliation': 'Family Medicine Residency, Dwight David Eisenhower Army Medical Center, Fort Gordon, GA, USA.'}]",The Journal of family practice,[]
33,32359042,"Efficacy of the eCHECKUP TO GO for High School Seniors: Sex Differences in Risk Factors, Protective Behavioral Strategies, and Alcohol Use.","OBJECTIVE


The purpose of this randomized controlled study was to examine sex as a moderator of the efficacy of a brief, web-based personalized feedback intervention (eCHECKUP TO GO) on decreasing cognitive risk factors for alcohol use, increasing protective behavioral strategies, and reducing alcohol use among high school seniors.
METHOD


Participants (n = 311) were high school seniors randomized by class period to the eCHECKUP TO GO intervention or assessment-only control group. Participants completed online surveys at baseline and 30-day follow-up (91.0%; n = 283).
RESULTS


Students in the intervention group reported a significant reduction in normative perceptions of peer drinking, positive alcohol expectancies, and alcohol use relative to those in the control group. Intervention effects for perceptions of frequency of peer drunkenness and frequency of alcohol use were moderated by sex, with results favoring females. In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity. Further, we did not find significant intervention or moderator effects for protective behavioral strategies.
CONCLUSIONS


Results of this study extend the literature by demonstrating the efficacy of the eCHECKUP TO GO for both males and females on reducing cognitive risk factors and alcohol use, although results were significant for a broader range of variables for females. Results also indicate that program content regarding normative feedback and protective behavioral strategies may need modification to be more effective for this age group.",2020,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","['High School Seniors', 'Participants (n = 311) were high school seniors randomized by class period to the', 'high school seniors']","['eCHECKUP TO GO intervention or assessment-only control group', 'web-based personalized feedback intervention (eCHECKUP TO GO', 'eCHECKUP TO GO']","['normative perceptions of peer drinking, positive alcohol expectancies, and alcohol use relative']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",311.0,0.0172365,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Doumas', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Esp', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Turrisi', 'Affiliation': 'Biobehavioral Health and Prevention Research Center, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Biomolecular Research Center, Boise State University, Boise, Idaho.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flay', 'Affiliation': 'Initiative for Healthy Schools, Boise State University, Boise, Idaho.'}]",Journal of studies on alcohol and drugs,[]
34,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
35,32362377,Effective self-stretching of carpal ligament for the treatment of carpal tunnel syndrome: A double-blinded randomized controlled study.,"INTRODUCTION


Carpal tunnel syndrome (CTS) is the most common nerve entrapment syndrome worldwide. There are limited studies on the effectiveness of carpal ligament stretching on symptomatic and electrophysiologic outcomes.
PURPOSE OF THE STUDY


The purpose of this study was to evaluate the effect of self-myofascial stretching of the carpal ligament on symptom outcomes and nerve conduction findings in persons with CTS.
STUDY DESIGN


This is a prospective, double-blinded, randomized, placebo-controlled trial.
METHODS


Eighty-three participants diagnosed with median mononeuropathy across the wrist by nerve conduction study were randomized 1:1 to sham treatment or self-carpal ligament stretching. Participants were instructed to perform the self-treatment four times a day for six weeks. Seventeen participants in the sham treatment group and 19 participants in the carpal ligament stretching group completed the study. Pre- and post-treatment outcome measures included subjective complaints, strength, nerve conduction findings, and functional scores.
RESULTS


Groups were balanced on age, sex, hand dominance, symptom duration, length of treatment, presence of nocturnal symptoms, and compliance with treatment. Even though the ANOVA analyses were inconclusive about group differences, explorative post hoc analyses revealed significant improvements in numbness (P = .011, Cohen's d = .53), tingling (P = .007, Cohen's d = .60), pinch strength (P = .007, Cohen's d = -.58), and symptom severity scale (P = .007, Cohen's d = .69) for the treatment group only.
CONCLUSIONS


The myofascial stretching of the carpal ligament showed statistically significant symptom improvement in persons with CTS. Larger comparative studies that include other modalities such as splinting should be performed to confirm the effectiveness of this treatment option.",2020,"Even though the ANOVA analyses were inconclusive about group differences, explorative post hoc analyses revealed significant improvements in numbness (P = .011, Cohen's d = .53), tingling (P = .007, Cohen's d = .60), pinch strength (P = .007, Cohen's d = -.58), and symptom severity scale (P = .007, Cohen's d = .69) for the treatment group only.
","['carpal tunnel syndrome', 'Seventeen participants in the sham treatment group and 19 participants in the carpal ligament stretching group completed the study', 'persons with CTS', 'Eighty-three participants diagnosed with median mononeuropathy across the wrist by nerve conduction study']","['self-myofascial stretching', 'carpal ligament', 'carpal ligament stretching', 'sham treatment or self-carpal ligament stretching', 'placebo']","['pinch strength', 'tingling', 'symptom severity scale', 'numbness', 'subjective complaints, strength, nerve conduction findings, and functional scores']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007285', 'cui_str': 'Bone structure of carpus'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751922', 'cui_str': 'Median neuropathy'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0007285', 'cui_str': 'Bone structure of carpus'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C1286635', 'cui_str': 'Nerve conduction - finding'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",83.0,0.0616565,"Even though the ANOVA analyses were inconclusive about group differences, explorative post hoc analyses revealed significant improvements in numbness (P = .011, Cohen's d = .53), tingling (P = .007, Cohen's d = .60), pinch strength (P = .007, Cohen's d = -.58), and symptom severity scale (P = .007, Cohen's d = .69) for the treatment group only.
","[{'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Shem', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Santa Clara Valley Medical Center, San Jose, CA, USA. Electronic address: kazuko.shem@hhs.sccgov.org.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dirlikov', 'Affiliation': 'Rehabilitation Research Center, Santa Clara Valley Medical Center, San Jose, CA, USA.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.002']
36,32360666,Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India.,"OBJECTIVES


Evaluate and compare contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA) in married lactating women (20-35 years) using the progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD) during the first postpartum year.
STUDY DESIGN


We conducted a one-year multicenter, non-randomized, non-inferiority, open-label, comparative trial at 20 centers in India and compared efficacy, safety, continuation and LA plus feeding patterns and growth/well-being of participants' infants. Women used four 3-month PVRs consecutively (lost PVRs were not replaced) and were to breastfeed at least four times/day. We used Pearl Index (PI) and Kaplan Meier (K-M) rates to analyze pregnancy and K-M for continuation.
RESULTS


We enrolled 789 women (459 PVR, 330 IUD). Neither PI nor K-M one-year pregnancy rates differed significantly between groups (PI: PVR-0.62; IUD-0.35); (K-M: PVR-0.7; IUD-0.4, p = 0.58). Continuation rates at 12 months were 78.5% (IUD) vs. 56.9% (PVR) (p < 0.001). Ring expulsions and menorrhagia were the most common discontinuation among PVR/IUD users respectively. The median duration of LA among PVR vs. IUD users was 405 vs. 120 days (p < 0.001). Both groups reported similar adverse events (PVR: 24.2%; IUD: 23.0%); there were no serious adverse events among PVR users. Infants from both groups fed 12-7 times/day and grew at expected rates.
CONCLUSIONS


Efficacy and safety outcomes were comparable among women in both groups. Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users. Infant breastfeeding and growth patterns/well-being were favorable in both groups.
IMPLICATIONS


PVR, a user-controlled device, offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being.",2020,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","['lactating women', 'lactating mothers', '789 women (459 PVR, 330 IUD', 'married lactating women (20-35 years) using the', ""participants' infants""]","['progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD', 'Progesterone vaginal ring']","['PI nor K-M one-year pregnancy rates', 'median duration of LA', 'Continuation rates', 'Pearl Index (PI) and Kaplan Meier (K-M) rates', 'Efficacy and safety outcomes', 'adverse events', 'contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0473315', 'cui_str': 'Lactational amenorrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",789.0,0.262346,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","[{'ForeName': 'Malabika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India. Electronic address: malaroy69@gmail.com.'}, {'ForeName': 'Avishek', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Merkatz', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Plagianos', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Mohcine', 'Initials': 'M', 'LastName': 'Alami', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Gaur', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Kumudha', 'Initials': 'K', 'LastName': 'Aruldas', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Sussman', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Government Medical College, SMGS Hospital, Jammu, India; Postgraduate Institute of Medical Education and Research Chandigarh, India; Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India; K.G. Medical University, Lucknow, India; Motilal Nehru Medical College and Hospital, Prayagraj, India; GSVM Medical College and Hospital, Kanpur, India; SMS Medical College and Zanana Hospital, Jaipur, India; Institute of Obstetrics and Gynecology, Madras Medical College, Chennai, India; Government Medical College and SAT Hospital, Thiruvananthapuram, India; Jawaharlal Nehru Medical College and Hospital, Belagavi, India; Patna Medical College and Hospital, Patna, India; R.G. Kar Medical College and Hospital, Kolkata, India; Medical College and Eden Hospital, Kolkata, India; SCB Medical College and Hospital, Cuttack, India; Seth GS Medical College and KEM Hospital, Mumbai, India; KEM Hospital, Pune, India; Grant Medical College and Sir JJ Group of Hospitals, Mumbai, India; Goa Medical College and Hospital, Goa, India; Indian Council of Medical Research - National Institute for Research in Reproductive Health, Mumbai, India.'}]",Contraception,['10.1016/j.contraception.2020.04.016']
37,32369398,A Pilot Study on the Efficacy of Stress Relief Programs for Family Caregivers of Older People with Dementia.,"The aim of this study was to evaluate the effects of stress-relief programs on positive aspects of caregiving and depression among caregivers of older people with dementia. A quasi-experimental design was employed. Participants in the experimental group received a 8-week period and 120 minutes each session cognitive-behavioral therapy. Participants in the control group received standard health education. Stress relief programs may alleviate depression and increase positive aspects of caregiving among family caregivers of older people with dementia. These findings will help health professionals to implement stress-relief strategies for family caregivers of older people with dementia, or to use those strategies to increase positive aspects of caregiving, or to alleviate depression in caregivers.",2020,The aim of this study was to evaluate the effects of stress-relief programs on positive aspects of caregiving and depression among caregivers of older people with dementia.,"['caregivers of older people with dementia', 'family caregivers of older people with dementia', 'Family Caregivers of Older People with Dementia']","['8-week period and 120\u2009minutes each session cognitive-behavioral therapy', 'standard health education', 'stress-relief programs', 'Stress Relief Programs']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.023203,The aim of this study was to evaluate the effects of stress-relief programs on positive aspects of caregiving and depression among caregivers of older people with dementia.,"[{'ForeName': 'Pi-Lan', 'Initials': 'PL', 'LastName': 'Tsai', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taoyuan City, Taiwan (R.O.C.).'}, {'ForeName': 'Shu-Min', 'Initials': 'SM', 'LastName': 'Chan', 'Affiliation': 'Department of Long Term Care and Management, Chung Hwa University of Medical Technology No. 89, Tainan City, Taiwan (R.O.C.).'}, {'ForeName': 'Ru Shang', 'Initials': 'RS', 'LastName': 'Jiang', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Puzi City, Taiwan (R.O.C.).'}, {'ForeName': 'Shwu-Hua', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Linkou Chang Gung Memorial Hospital, Taiwan, (R.O.C.).'}, {'ForeName': 'Jung Lung', 'Initials': 'JL', 'LastName': 'Hsu', 'Affiliation': 'Department of Neurology, Chang Gung Memorial Hospital Linkou Medical Center and College of Medicine, Chang-Gung University, Taoyuan, Taiwan.'}]",Issues in mental health nursing,['10.1080/01612840.2019.1710006']
38,32369844,Modeling to Predict Factor VIII Levels Associated with Zero Bleeds in Patients with Severe Hemophilia A Initiated on Tertiary Prophylaxis.,"BACKGROUND


Factor VIII (FVIII) trough levels > 1 IU/dL in patients with severe hemophilia A receiving regular prophylaxis may optimize bleed protection.
OBJECTIVES


In this post hoc analysis of patients receiving tertiary prophylaxis for approximately 1 year, the relationship between estimated FVIII levels and reported bleeds was investigated to predict the potential for zero bleeds.
METHODS


Sixty-three patients (median [range] age, 28 [7-59] years) with severe hemophilia A (229 bleeds) were included. FVIII levels at time of each bleed were estimated from single-dose individual pharmacokinetics. The highest estimated FVIII level at which patients experienced a bleed was considered the ""potentially effective trough level"" for that bleed type. Kaplan-Meier estimates of proportions of patients with no bleeds above certain estimated FVIII levels were determined. Those not experiencing a bleed in the trial were assumed to have a bleed at 0 IU/dL (pragmatic approach) or at their median trough level (conservative approach).
RESULTS


Kaplan-Meier estimates based on pragmatic approach predicted zero all bleeds, joint bleeds, and spontaneous joint bleeds in 1 year in 40, 43, and 63% of patients, respectively, when the potentially effective trough FVIII level was set at 1 IU/dL. Between 1 and 10 IU/dL, every 1 IU/dL rise in estimated FVIII level was associated with an additional 2% of patients having zero all bleeds.
CONCLUSION


This post hoc analysis confirms benefits with trough levels of approximately 1 to 3 IU/dL in most patients starting tertiary prophylaxis; prophylaxis with higher trough levels may help patients to achieve zero bleeds.",2020,Kaplan-Meier estimates of proportions of patients with no bleeds above certain estimated FVIII levels were determined.,"['patients with severe hemophilia', 'Patients with Severe Hemophilia A Initiated on Tertiary Prophylaxis', 'Sixty-three patients (median [range] age, 28 [7-59] years) with severe hemophilia A (229 bleeds) were included']",['Factor VIII (FVIII'],"['FVIII levels', 'bleeds, joint bleeds, and spontaneous joint bleeds', 'FVIII level', 'effective trough FVIII level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0015506', 'cui_str': 'Factor VIII'}]","[{'cui': 'C0200399', 'cui_str': 'Factor VIII assay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018924', 'cui_str': 'Hemarthrosis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444506', 'cui_str': 'Trough'}]",,0.0794884,Kaplan-Meier estimates of proportions of patients with no bleeds above certain estimated FVIII levels were determined.,"[{'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Chowdary', 'Affiliation': 'Katharine Dormandy Haemophilia and Thrombosis Centre, Royal Free London NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Kathelijn', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Van Creveldkliniek, Department of Hematology, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Collins', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cotterill', 'Affiliation': 'Baxalta Innovations GmbH, a member of the Takeda group of companies, Vienna, Austria.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Konkle', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Blanchette', 'Affiliation': 'Department of Paediatrics, Division of Haematology/Oncology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Pipe', 'Affiliation': 'Department of Pediatrics and Pathology, University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Berntorp', 'Affiliation': 'Department of Translational Medicine and Centre for Thrombosis and Haemostasis, Lund University, Malmö, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wolfsegger', 'Affiliation': 'Baxalta Innovations GmbH, a member of the Takeda group of companies, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Engl', 'Affiliation': 'Baxalta Innovations GmbH, a member of the Takeda group of companies, Vienna, Austria.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Spotts', 'Affiliation': 'Baxalta US Inc, a member of the Takeda group of companies, Lexington, Massachusetts, United States.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1709519']
39,32293959,Re: Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-Up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).,,2020,,['Clinically Localized Prostate Cancer'],['Re: Radical Prostatectomy or Observation'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],,0.0173406,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001056.01']
40,32293960,Re: Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression among Men with Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,,2020,,['Men with Early-Stage Prostate Cancer'],['Behavioral Intervention to Increase Vegetable Consumption'],['Cancer Progression'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}]",,0.0490649,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001056']
41,32358417,Excisional goniotomy vs trabecular microbypass stent implantation: a prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma.,"PURPOSE


To compare reduction in intraocular pressure (IOP) and IOP-lowering medication in eyes undergoing excisional goniotomy with Kahook Dual Blade (KDB) vs iStent microbypass implantation, both combined with phacoemulsification, in eyes with mild to moderate open-angle glaucoma (OAG).
SETTING


Nine practices in the United States.
DESIGN


Prospective, randomized, active-controlled, parallel-group clinical trial.
METHODS


Eyes were randomized to KDB-Phaco or iStent-Phaco group. Demographics, corrected distance visual acuity, IOP, IOP-lowering medications, and adverse events were collected at baseline and at day 1, week 1, and months 1, 3, 6, and 12 postoperatively. The primary outcome measure was the proportion of eyes at 12 months with IOP reduction of 20% or greater or IOP medication reduction of 1 or more compared with baseline.
RESULTS


For this study, 164 eyes of 164 patients were analyzed (82 in each group). Mean IOP was reduced at 12 months compared with baseline from 18.5 (standard of error 0.4) to 15.4 (0.4) mm Hg in the KDB-Phaco group and from 18.5 (0.3) to 16.1 (0.4) mm Hg in the iStent-Phaco group (P = .24). Mean IOP-lowering medications were reduced from 1.3 (0.1) to 0.3 (0.1) in the KDB-Phaco group and from 1.4 (0.1) to 0.4 (0.1) in the iStent-Phaco group (P = .17). Among study completers, the primary outcome was attained in 74 (93.7%) of 79 patients of KDB-Phaco eyes and 65 (83.3%) of 78 patients of iStent-Phaco eyes (P = .04). Both procedures had similar safety profiles.
CONCLUSIONS


Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild to moderate OAG and cataract. Significantly, more KDB-Phaco eyes than iStent-Phaco eyes met the primary outcome of 20% or greater IOP reduction or 1 or more medication reduction at 12 months.",2020,Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild-moderate OAG and cataract.,"['eyes with mild to moderate open-angle glaucoma', '164 eyes/164 patient were analyzed (82 in each group', 'Eyes', 'eyes with mild-moderate open-angle glaucoma (OAG', 'eyes undergoing excisional goniotomy with', 'Nine practices in the United States']","['Excisional goniotomy vs trabecular microbypass stent implantation', 'KDB-Phaco or iStent-Phaco', 'Kahook Dual Blade v iStent microbypass implantation, both combined with phacoemulsification']","['Mean IOP-lowering medications', 'Mean IOP', 'intraocular pressure (IOP) and IOP-lowering medication', 'proportion of eyes at month 12 with IOP reduction >20% or IOP medication reduction', 'Demographics, corrected distance visual acuity, IOP, IOP-lowering medications, and adverse events']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.251138,Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild-moderate OAG and cataract.,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Falkenberry', 'Affiliation': 'From the Gundersen Health System (Falkenberry), La Crosse, Wisconsin, The Eye Centers of Racine & Kenosha (Singh), Racine, Wisconsin, Northern New Jersey Eye Institute (Crane), South Orange, New Jersey, University of Louisville (Haider), Louisville, Kentucky, Ochsner Clinic Baton Rouge (Morgan, Grenier), Baton Rouge, Louisiana, Sacramento Eye Consultants (Brubaker), Sacramento, California, University of Pittsburgh (Balasubramani), Pittsburgh, Pennsylvania, Mayo Clinic (Dorairaj), Jacksonville, Florida, USA.'}, {'ForeName': 'Inder Paul', 'Initials': 'IP', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Crane', 'Affiliation': ''}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Haider', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Morgan', 'Affiliation': ''}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Grenier', 'Affiliation': ''}, {'ForeName': 'Jacob W', 'Initials': 'JW', 'LastName': 'Brubaker', 'Affiliation': ''}, {'ForeName': 'Goundappa K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': ''}, {'ForeName': 'Syril', 'Initials': 'S', 'LastName': 'Dorairaj', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000229']
42,32372750,Assessment of the Feasibility and Acceptability of Using Water Pasteurization Indicators to Increase Access to Safe Drinking Water in the Peruvian Amazon.,"Approximately two billion people lack access to microbiologically safe drinking water globally. Boiling is the most popular household water treatment method and significantly reduces diarrheal disease, but is often practiced inconsistently or ineffectively. The use of low-cost technologies to improve boiling is one approach with potential for increasing access to safe drinking water. We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015. A total of 28 randomly selected households were enrolled from a rural and a peri-urban community. All households trialed two WAPI designs, each for a 2-week period. Ninety-six percent of participants demonstrated the correct use of the WAPIs at the end of each trial, and 88% expressed satisfaction with both WAPI models. Ease of use, short treatment time, knowledge of the association between WAPI use and improved health, and the taste of treated water were among the key factors that influenced acceptability. Ease of use was the key factor that influenced design preference. Participants in both communities preferred a WAPI with a plastic box that floated on the water's surface compared with a WAPI with a wire that was dipped into the pot of drinking water while it was heating (77% versus 15%,  P  < 0.001); we selected the box design for a subsequent randomized trial of this intervention. The high feasibility and acceptability of the WAPIs in this study suggest that these interventions have potential to increase access to safe water in resource-limited settings.",2020,We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015.,"['Peruvian Amazon in 2015', '28 randomly selected households were enrolled from a rural and a peri-urban community']",['water pasteurization indicators (WAPIs'],['diarrheal disease'],"[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0597885', 'cui_str': 'Pasteurization'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]","[{'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}]",28.0,0.026785,We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015.,"[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Heitzinger', 'Affiliation': 'Innovacion Por la Salud Y el Desarollo (IPSYD), Asociación Benéfica Prisma, Lima, Peru.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Hawes', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Claudio A', 'Initials': 'CA', 'LastName': 'Rocha', 'Affiliation': 'U.S. Naval Medical Research Unit No. 6, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Regional Center for Disease Prevention and Control, Loreto Regional Ministry of Health, Iquitos, Peru.'}, {'ForeName': 'Carlton A', 'Initials': 'CA', 'LastName': 'Evans', 'Affiliation': 'IFHAD: Innovation for Health and Development, Laboratory of Research and Development, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.18-0963']
43,32371116,Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial.,"BACKGROUND & AIMS


One-fourth of colorectal neoplasias are missed during screening colonoscopies; these can develop into colorectal cancer (CRC). Deep learning systems allow for real-time computer-aided detection (CADe) of polyps with high accuracy. We performed a multicenter, randomized trial to assess the safety and efficacy of a CADe system in detection of colorectal neoplasias during real-time colonoscopy.
METHODS


We analyzed data from 685 subjects (61.32 ± 10.2 years old; 337 men) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or workup due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at 3 centers in Italy from September through November 2019. Patients were randomly assigned (1:1) to groups who underwent high-definition colonoscopies with the CADe system or without (controls). The CADe system included an artificial intelligence-based medical device (GI-Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display a green box over suspected lesions. A minimum withdrawal time of 6 minutes was required. Lesions were collected and histopathology findings were used as the reference standard. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time.
RESULTS


The ADR was significantly higher in the CADe group (54.8%) than in the control group (40.4%) (relative risk [RR], 1.30; 95% confidence interval [CI], 1.14-1.45). Adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07 ±1.54) than in the control group (mean 0.71 ± 1.20) (incidence rate ratio, 1.46; 95% CI, 1.15-1.86). Adenomas 5 mm or smaller were detected in a significantly higher proportion of subjects in the CADe group (33.7%) than in the control group (26.5%; RR, 1.26; 95% CI, 1.01-1.52), as were adenomas of 6 to 9 mm (detected in 10.6% of subjects in the CADe group vs 5.8% in the control group; RR, 1.78; 95% CI, 1.09-2.86), regardless of morphology or location. There was no significant difference between groups in withdrawal time (417 ± 101 seconds for the CADe group vs 435 ± 149 for controls; P = .1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
CONCLUSIONS


In a multicenter, randomized trial, we found that including CADe in real-time colonoscopy significantly increases ADR and adenomas detected per colonoscopy without increasing withdrawal time. ClinicalTrials.gov no: 04079478.",2020,"There was no significant difference between groups in withdrawal time (417±101 sec for the CADe group vs 435±149 for controls; P=.1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
","['685 subjects (61.32±10.2 years old; 337 women) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or work up due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at three centers in Italy from September through November 2019', 'polyps with high-accuracy']","['Real-Time Computer-Aided Detection', 'high-definition colonoscopies with the CADe system or without (controls', 'CADe system']","['adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma', 'ADR', 'resection of non-neoplastic lesions', 'withdrawal time', 'safety and efficacy', 'Adenomas detected per colonoscopy', 'adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]",,0.129523,"There was no significant difference between groups in withdrawal time (417±101 sec for the CADe group vs 435±149 for controls; P=.1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy. Electronic address: alessandro.repici@hunimed.eu.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Badalamenti', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maselli', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Correale', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rondonotti', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spadaccini', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Thanyan Alghanim Center for Gastroenterology and Hepatology, Alamiri Hospital, Kuwait, Kuwait.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fugazza', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderloni', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Piera Alessia', 'Initials': 'PA', 'LastName': 'Galtieri', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Pellegatta', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Carrara', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Di Leo', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Craviotto', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lamonaca', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorenzetti', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Andrealli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Kansas City Veterans Affairs Hospital, Kansas City, Missouri.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosch', 'Affiliation': 'Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}]",Gastroenterology,['10.1053/j.gastro.2020.04.062']
44,32366155,The value of sorafenib trough levels in patients with advanced hepatocellular carcinoma - a substudy of the SORAMIC trial.,"Background : Sorafenib for advanced hepatocellular carcinoma (HCC) is dose adjusted by toxicity. Preliminary studies have suggested an association between plasma concentrations of sorafenib and its main metabolite (M2) and clinical outcomes. This study aimed to validate these findings and establish target values for sorafenib trough concentrations. Methods:  Patients with advanced HCC were prospectively recruited within a multicenter phase II study (SORAMIC). Patients with blood samples available at trough level were included for this pharmacokinetic (PK) substudy. Trough plasma concentrations of sorafenib and its main metabolite (M2) were associated with sorafenib-related toxicity and overall survival (OS). Results : Seventy-four patients were included with a median OS of 19.7 months (95% CI 16.1-23.3). Patients received sorafenib for a median of 51 weeks (IQR 27-62) and blood samples were drawn after a median of 25 weeks (IQR 10-42). Patients had a median trough concentration of 3217 ng/ml (IQR 2166-4526) and 360 ng/ml (IQR 190-593) with coefficients of variation of 65% and 146% for sorafenib and M2, respectively. Patients who experienced severe sorafenib-related toxicity received a lower average daily dose (551 vs 730 mg/day,  p  = .003), but showed no significant differences in sorafenib (3298 vs 2915 ng/ml,  p  = .442) or M2 trough levels (428 vs 283 ng/ml,  p  = .159). Trough levels of sorafenib or M2 showed no significant association with OS. Conclusions:  In patients with advanced HCC treated with sorafenib, the administered dose, trough levels of sorafenib or M2, and clinical outcomes were poorly correlated. Toxicity-adjusted dosing remains the standard for sorafenib treatment.",2020,Trough plasma concentrations of sorafenib and its main metabolite (M2) were associated with sorafenib-related toxicity and overall survival (OS).,"['patients with advanced HCC treated with', 'Patients with advanced HCC', 'Patients with blood samples available at trough level were included for this pharmacokinetic (PK) substudy', 'patients with advanced hepatocellular carcinoma - a substudy of the SORAMIC trial', 'advanced hepatocellular carcinoma (HCC']","['sorafenib', ' : Sorafenib']","['toxicity', 'M2 trough levels', 'toxicity and overall survival (OS', 'median trough concentration', 'Trough plasma concentrations of sorafenib and its main metabolite (M2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",74.0,0.259096,Trough plasma concentrations of sorafenib and its main metabolite (M2) were associated with sorafenib-related toxicity and overall survival (OS).,"[{'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Labeur', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Quincy', 'Initials': 'Q', 'LastName': 'Hofsink', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'R Bart', 'Initials': 'RB', 'LastName': 'Takkenberg', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Otto M', 'Initials': 'OM', 'LastName': 'van Delden', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ron A A', 'Initials': 'RAA', 'LastName': 'Mathôt', 'Affiliation': 'Hospital Pharmacy, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Schinner', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malfertheiner', 'Affiliation': 'Department of Medicine II, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Amthauer', 'Affiliation': 'Department of Nuclear Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schütte', 'Affiliation': 'Department of Internal Medicine and Gastroenterology, Niels-Stensen-Kliniken, Marienhospital Osnabrück, Osnabrück, Germany.'}, {'ForeName': 'Bristi', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': 'Department of Oncology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Kuhl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Department of Medicine II, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Klümpen', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1759826']
45,32364091,The effects of pre-sleep consumption of casein protein on next-morning measures of RMR and appetite compared between sedentary pre- and postmenopausal women.,"The purpose of the present study was to compare next-morning responses of RMR and appetite to pre-sleep consumption of casein protein (CP) in pre- and postmenopausal women. The study was a randomised, crossover, double-blind, placebo-controlled trial. Seven sedentary premenopausal (age: 19·9 (sd 1·2) years; BMI: 23·1 (sd 2·6) kg/m2) and seven sedentary postmenopausal (age: 56·4 (sd 4·9) years; BMI: 26·3 (sd 3·5) kg/m2) women participated. During visit one, anthropometrics and body composition were measured. Following visit one, subjects consumed either CP (25 g) or placebo (PL) ≥2 h after their last meal and ≤30 min prior to sleep on the night before visits two and three. Visits two and three occurred ≥1 week after visit one and were 48 h apart. During visits two and three, RMR (VO2), RER and appetite were measured via indirect calorimetry and visual analogue scale, respectively. Anthropometrics and body composition were analysed by one-way ANOVA. RMR and measures of appetite were analysed using a 2 × 2 (menopause status × CP/PL) repeated-measures ANOVA. Significance was accepted at P ≤ 0·05. RMR was significantly lower in postmenopausal compared with premenopausal women under both conditions (P = 0·003). When consumed pre-sleep CP did not alter RMR, RER or appetite compared with PL when assessed next morning in pre- and postmenopausal women. These data contribute to growing evidence that pre-sleep consumption of protein is not harmful to next-morning metabolism or appetite. In addition, these data demonstrate that menopause may not alter next-morning RMR, RER or appetite after pre-sleep consumption of CP.",2020,RMR was significantly lower in postmenopausal compared to premenopausal women under both conditions (p=0.003).,"['pre and postmenopausal women', 'Seven sedentary premenopausal (age: 19.9 (SD 1.2) years', 'BMI: 23.1(SD 2.6) kg/m2) and seven sedentary postmenopausal (age: 56.4 (SD 4.9) years, BMI: 26.3 (SD 3.5) kg/m2) women participated']","['resting metabolic rate (RMR) and appetite to pre-sleep consumption of casein protein (CP', 'CP', 'placebo (PL', 'placebo']","['RMR and measures of appetite', 'RMR, RER, or appetite', 'RMR', 'next-morning RMR, RER, or appetite', 'Anthropometrics and body composition', 'RMR (VO2), respiratory exchange ratio (RER), and appetite were measured via indirect calorimetry and visual analogue scale']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",7.0,0.0685866,RMR was significantly lower in postmenopausal compared to premenopausal women under both conditions (p=0.003).,"[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Schattinger', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Leonard', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Pappas', 'Affiliation': 'Capital Regional Medical Care, Tallahassee, FL32312, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Panton', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001506']
46,32359843,Long-term Visual Outcomes after Release from Protocol in Patients who Participated in the Inhibition of VEGF in Age-related Choroidal Neovascularisation (IVAN) Trial.,"PURPOSE


To describe visual outcomes, frequency of treatment and monitoring visits, and anti-vascular endothelial growth factor drugs used in usual care in participants who exited a trial in which treatment for neovascular age-related macular degeneration (nAMD) was initiated with bevacizumab or ranibizumab.
DESIGN


Multicenter cohort study up to 7 years after trial exit.
PARTICIPANTS


Patients enrolled in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial; after excluding participants from 2 sites and who died or withdrew during the trial, 537 were included in this follow-up cohort.
METHODS


Data were collected between May 26, 2016, and August 24, 2017. Distance visual acuity (DVA) (letters read) in both eyes and treatments for nAMD administered to either eye at all usual care visits were extracted from medical records of all participants until the point of data collection (duration of study eye monitoring).
MAIN OUTCOME MEASURES


Rate of change of DVA during active surveillance of the study eye (study eye monitoring), estimated using a multivariable linear random effects model. Other outcome measures were visit and treatment frequency and switches in anti-vascular endothelial growth factor (VEGF) drug.
RESULTS


Data were obtained for 99% (532/537) of eligible participants. The median duration of study eye monitoring after IVAN exit was 3.3 years (interquartile range [IQR], 1.3-4.7), and median DVA was 58.0 letters (IQR, 34.0-73.0). Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year. Injection rate did not influence the rate of change in DVA after adjusting for key covariates. After IVAN exit, 174 participants (32%) received no treatment; 332 of 358 (93%) were treated first with ranibizumab, 78 (23%) of whom switched to aflibercept. The DVA was similar among participants who switched or did not switch at the end of study monitoring.
CONCLUSIONS


Approximately 5 years after the IVAN study finished, with unprecedented completeness of follow-up for such a trial, the trajectory of functional decline in the study eye was shown to be greater than that previously reported for incomplete trial cohorts. Anti-VEGF injection rates and treatment switches were not important factors in determining visual acuity outcomes.",2020,"Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year.","['participants who switched or did not switch at the end of study monitoring', 'Patients who Participated in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) Trial', 'Multicenter cohort study up to 7 years after trial exit', 'Data were collected between May 26, 2016, and August 24, 2017', 'Patients enrolled in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial; after excluding participants from 2 sites and who died or withdrew during the trial, 537 were included in this follow-up cohort', 'participants who exited a trial in which treatment for neovascular age-related macular degeneration (nAMD']","['bevacizumab or ranibizumab', 'ranibizumab', 'aflibercept']","['Distance visual acuity (DVA) (letters read', 'rate of change in DVA', 'visit and treatment frequency and switches in anti-vascular endothelial growth factor (VEGF) drug', 'median duration of study eye monitoring after IVAN exit', 'visual acuity outcomes', 'Rate of change of DVA during active surveillance of the study eye (study eye monitoring', 'Injection rate', 'median DVA']","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1283169', 'cui_str': 'Monitoring - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",537.0,0.324775,"Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year.","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Katherine Alyson', 'Initials': 'KA', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland. Electronic address: u.chakravarthy@qub.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.020']
47,32301241,Health professionals' perspectives on delivering home and hospital management at diagnosis for children with type 1 diabetes: A qualitative study from the Delivering Early Care in Diabetes Evaluation trial.,"OBJECTIVE


To explore the delivery of home and hospital management at diagnosis of type 1 diabetes in childhood and any impact this had on health professionals delivering care.
METHODS


This qualitative study was undertaken as part of the Delivering Early Care in Diabetes Evaluation randomized controlled trial where participants were individually randomized to receive initiation of management at diagnosis, to home or hospital. Semi-structured telephone interviews were planned with a purposive sample of health professionals involved with the delivery of home and hospital management, to include consultants, diabetes and research nurses, and dieticians from the eight UK centres taking part. The interview schedule focused on their experiences of delivering the two models of care; preferences, impact, and future plans. Data were subject to thematic analysis.
RESULTS


Twenty-two health professionals participated, represented by consultants, diabetes and research nurses, and dieticians. Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members. Nurses described a special bond and lasting relationship that they developed with the home managed children and families. Consultants expressed concern that it jeopardized their relationship with families. Dieticians reported being unable to deliver short bursts of education to families in the home managed arm. All health professionals were equally divided over which was logistically easier to deliver.
CONCLUSIONS


A hybrid approach, of a brief stay in hospital and early home management, offers a pragmatic solution to the advantages and challenges presented by both systems.",2020,"Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members.","['children with type 1 diabetes', 'Twenty two health professionals participated, represented by consultants, diabetes and research nurses, and dietitians']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}]",[],[],,0.0531353,"Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Townson', 'Affiliation': 'Centre for Trials Research (CTR), College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Lowes', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research (CTR), College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research (CTR), College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Gregory', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}]",Pediatric diabetes,['10.1111/pedi.13023']
48,32363765,"Immediate vs conventional loading of Facility-Equator system in mandibular overdenture wearers: 1-year RCT with clinical, biological, and functional evaluation.","BACKGROUND


The use of immediate loading (IML) is still poorly explored in elderly patients and implant-retained mandibular overdenture (IMO) wearers. For this reason, more comparisons to conventional loading (CL) are required.
PURPOSE


To evaluate the clinical, biological, functional, and oral health-related quality of life (OHRQOL) influence of CL and IML loading on elders wearing IMO retained by the Facility-Equator system up to 1 year after implant installation.
MATERIAL AND METHODS


Twenty edentulous patients received two narrow diameter implants in the mandible; the loading type (CL or IML) was randomized. The clinical parameters were monitored along with prosthetic events, marginal bone loss (MBL) and bone level change (BLC), implant stability quotients (ISQ), masticatory performance outcomes, and Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) levels in the peri-implant crevicular fluid during the first year of loading. The OHRQoL was assessed via the Oral Health Impact Profile-EDENT questionnaire. Data were analyzed by the Mann-Whitney, χ 2  , Wilcoxon paired, and McNemar tests.
RESULTS


After 1 year, MBL, BLC and ISQ were statistically identical (P > .05) in the CL and IML groups. The probing depth at 12 months in the CL group (2.19 mm) was higher than in the IML group (1.29 mm; P ≤ .0001). TNF-α was 33.6% higher in the CL group at 6 months (P = .043), while IL-1β was significantly higher in the IML group up to 6 months. The survival rate was 90% in the CL group and 85% in the IML group; 33 prosthetic events occurred in CL group and 23 in IML group.
CONCLUSIONS


After 12 months, both loading protocols are viable and result in similar clinical, biological, functional, and OHRQOL outcomes. However, IML generates better adaptation of the peri-implant tissues, faster improvement in OHRQoL and fewer prosthetic intercurrences than CL.",2020,"TNF-α was 33.6% higher in the CL group at 6 months (P = .043), while IL-1β was significantly higher in the IML group up to 6 months.","['elders wearing IMO retained by the Facility-Equator system up to 1\u2009year after implant installation', 'Twenty edentulous patients received two', 'elderly patients and implant-retained mandibular overdenture (IMO) wearers', 'mandibular overdenture wearers']","['narrow diameter implants in the mandible; the loading type (CL or IML', 'IML', 'CL and IML loading', 'conventional loading (CL', 'immediate loading (IML', 'Immediate vs conventional loading of Facility-Equator system']","['TNF-α', 'IL-1β', 'similar clinical, biological, functional, and OHRQOL outcomes', 'probing depth', 'MBL, BLC and ISQ', 'survival rate', 'prosthetic events, marginal bone loss (MBL) and bone level change (BLC), implant stability quotients (ISQ), masticatory performance outcomes, and Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) levels']","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}]",20.0,0.0639622,"TNF-α was 33.6% higher in the CL group at 6 months (P = .043), while IL-1β was significantly higher in the IML group up to 6 months.","[{'ForeName': 'Alessandra J', 'Initials': 'AJ', 'LastName': 'Schuster', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Raissa M', 'Initials': 'RM', 'LastName': 'Marcello-Machado', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Amália M', 'Initials': 'AM', 'LastName': 'Bielemann', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Anna Paula da Rosa', 'Initials': 'APDR', 'LastName': 'Possebon', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Otacílio L', 'Initials': 'OL', 'LastName': 'Chagas Júnior', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Maxillofacial Prosthodontics, School of Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Faot', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}]",Clinical implant dentistry and related research,['10.1111/cid.12902']
49,32376105,Effects of an Eating Ability Promotion Program for Community-Dwelling Older Adults.,"OBJECTIVE


Taiwan is projected to become a super-aged society in 2026. Taiwan's government introduced an innovative preventive care policy to improve aging-related conditions in 2017. In this study, we examine the effectiveness of an eating ability promotion program (EAPP) on the physical and mental performance of community-dwelling older adults.
DESIGN


Single-masked, cluster randomized trial.
SETTING


Two community care stations in Taichung, Taiwan.
PARTICIPANTS


Volunteers were recruited from these 2 community care stations. The 70 participants were aged ≥60 years, able to walk independently and take care of themselves, and understood Mandarin or Taiwanese.
INTERVENTION


The volunteers were randomly assigned to an intervention; 40 participated in EAPP training courses (experimental group) and 30 participated in originally scheduled activities only (control group). EAPP training courses were conducted in the care stations 4 hours per week for 12 weeks (for a total of 48 hours).
MEASURES


The physical performance outcomes were oral health, nutritional status, and fragility, assessed using the Oral Health Assessment Tool, the Mini Nutritional Assessment, and the Study of Osteoporotic Fractures fragility index, respectively. Cognitive function was evaluated with the Mini-Cog test. Measurements were performed at baseline, at the end of the 12-week intervention, and 1 month later.
RESULTS


Following the EAPP intervention, controlling for baseline differences, the oral health (F = 33.29, P < .001), nutritional status (F = 7.30, P = .009), and scale of fragility (F = 19.05, P < .001) of the participants in the experimental group were significantly better than those reported in the control group.
CONCLUSIONS AND IMPLICATIONS


Results of this preliminary study suggest that the EAPP intervention may be an effective approach for improving oral health, nutritional status, and fragility in community-dwelling older adults. This training course, which provides clear and concise information regarding eating ability strategies, should undergo further evaluation and, if demonstrated to be effective and cost-effective in broader trials, may be useful in promoting healthy living.",2020,"Following the EAPP intervention, controlling for baseline differences, the oral health (F = 33.29, P < .001), nutritional status (F = 7.30, P = .009), and scale of fragility (F = 19.05, P < .001) of the participants in the experimental group were significantly better than those reported in the control group.
","['Two community care stations in Taichung, Taiwan', 'community-dwelling older adults', '70 participants were aged ≥60\xa0years, able to walk independently and take care of themselves, and understood Mandarin or Taiwanese', 'Volunteers were recruited from these 2 community care stations', 'Community-Dwelling Older Adults']","['EAPP training courses (experimental group) and 30 participated in originally scheduled activities only (control group', 'EAPP', 'EAPP intervention', 'eating ability promotion program (EAPP', 'Eating Ability Promotion Program']","['oral health, nutritional status, and fragility, assessed using the Oral Health Assessment Tool, the Mini Nutritional Assessment, and the Study of Osteoporotic Fractures fragility index', 'oral health', 'Cognitive function', 'scale of fragility', 'nutritional status']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0566265', 'cui_str': 'Eating abilities'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",70.0,0.0165804,"Following the EAPP intervention, controlling for baseline differences, the oral health (F = 33.29, P < .001), nutritional status (F = 7.30, P = .009), and scale of fragility (F = 19.05, P < .001) of the participants in the experimental group were significantly better than those reported in the control group.
","[{'ForeName': 'Shang-Jung', 'Initials': 'SJ', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, Taichung Veterans General Hospital Puli Branch, Nantou, Taiwan; Department of Public Health, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Shwn-Huey', 'Initials': 'SH', 'LastName': 'Shieh', 'Affiliation': 'Department of Health Services Administration, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Yun-Ju', 'Initials': 'YJ', 'LastName': 'Lai', 'Affiliation': 'Department of Internal Medicine, Taichung Veterans General Hospital Puli Branch, Nantou, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Exercise Health Science, National Taiwan University of Sport, Taichung, Taiwan.'}, {'ForeName': 'Yun-Tong', 'Initials': 'YT', 'LastName': 'Shih', 'Affiliation': 'Shan-Mei Home Care Center, Nantou, Taiwan.'}, {'ForeName': 'Yueh-Juen', 'Initials': 'YJ', 'LastName': 'Hwu', 'Affiliation': 'College of Nursing in the Central Taiwan University of Science and Technology, Taichung, Taiwan. Electronic address: yjhwu@ctust.edu.tw.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.03.011']
50,32376217,Re Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial.,,2020,,['Vascular Surgery'],['Re Gentamicin Containing Collagen Implants'],[],"[{'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0590992', 'cui_str': 'Collagen implant'}]",[],,0.162808,,"[{'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Zaidi', 'Affiliation': 'Royal Stoke Vascular Unit, Royal Stoke Hospital, Stoke-on-Trent, UK. Electronic address: w4p94@students.keele.ac.uk.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jaipersad', 'Affiliation': 'Royal Stoke Vascular Unit, Royal Stoke Hospital, Stoke-on-Trent, UK.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Pherwani', 'Affiliation': 'Royal Stoke Vascular Unit, Royal Stoke Hospital, Stoke-on-Trent, UK.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Rajagopalan', 'Affiliation': 'Royal Stoke Vascular Unit, Royal Stoke Hospital, Stoke-on-Trent, UK.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.03.044']
51,32383680,"Efficacy and Impact of Digital HIV Care Navigation in Young People Living With HIV in San Francisco, California: Prospective Study.","BACKGROUND


Young people are disproportionately impacted by HIV infection and exhibit poor HIV care continuum outcomes. Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV. Youth-focused interventions are needed to improve HIV care continuum outcomes.
OBJECTIVE


This study assessed the preliminary efficacy and impact of a digital HIV care navigation intervention among young people living with HIV in San Francisco. Health electronic navigation (eNavigation or eNav) is a 6-month, text message-based, digital HIV care navigation intervention, in which young people living with HIV are connected to their own HIV care navigator through text messaging to improve engagement in HIV primary care.
METHODS


This study had a single-arm, prospective, pre-post design. The analysis included 120 young men who have sex with men or transwomen living with HIV aged between 18 and 34 years. We analyzed self-reported sociobehavioral information pre- and postintervention at baseline and 6 months, which was collected using computer-assisted self-interviewing surveys. We characterized the sample and built generalized estimating equation (GEE) models to assess differences in HIV care continuum outcomes at baseline and 6 months.
RESULTS


The characteristics according to the intervention completion status were not different from those of the overall sample. The mean age of the participants was 27.75 years (SD 4.07). Most participants (103/120, 85.8%) identified as men, and the sample was racially/ethnically diverse. At baseline, majority (99/120, 82.5%) of the participants had recently received primary HIV care, yet this was more likely in those who completed the intervention than in those who did not (54/60, 90% vs 45/60, 75%; χ 2 1 =4.68, P=.03). More than half of the sample reported taking antiretroviral therapy (92/120, 76.7%) and having an undetectable viral load (65/120, 54.2%). The 6-month follow-up surveys were completed by 73.3% (88/120) of participants, and these participants were not characteristically different from the overall sample at baseline. GEE models indicated that participants had increased odds of viral suppression at 6 months as compared with baseline. No relevant additive or multiplicative interactions were noted on comparing outcome effects over time according to intervention completion.
CONCLUSIONS


Digital HIV care navigation fills a critical gap in public health and HIV care systems, making these systems more responsive and accountable to the needs of the most vulnerable individuals. Our intervention bridges the time between primary care visits with interactive, tailored, personalized, and peer-delivered social support; information; and motivational interviewing to scaffold behavioral change. This study is part of the next wave of system-informed mHealth intervention research that will offer potentially disruptive solutions to traditional in-person delivered interventions and improve the health of the most vulnerable individuals.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/16406.",2020,Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV.,"['young people living with HIV in San Francisco', 'young people living with HIV', 'Young People Living With HIV in San Francisco, California', '120 young men who have sex with men or transwomen living with HIV aged between 18 and 34 years', 'Most participants (103/120, 85.8%) identified as men, and the sample was racially/ethnically diverse']","['Health electronic navigation (eNavigation or eNav', 'Digital HIV Care Navigation', 'Mobile health (mHealth) interventions', 'digital HIV care navigation intervention']",['viral suppression'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",120.0,0.0756441,Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Arayasirikul', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'Trujillo', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Victory', 'Initials': 'V', 'LastName': 'Le', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Wilson', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18597']
52,32376477,Effects of progressive resistance training prior to total HIP arthroplasty - a secondary analysis of a randomized controlled trial.,"OBJECTIVE


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


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


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


At 12 months after surgery, there was no additional effect of preoperative RT compared with THA alone, but rehabilitation was accelerated at 3 months.",2020,No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (,"['Patients scheduled for THA', 'patients undergoing total hip arthroplasty (THA', 'Eighty patients (70% women, 70.4 ± 7.6 years, BMI of 27.8 ± 4.6']","['THA', ""THA, or 'care-as-usual' (CG"", 'preoperative resistance training (RT', 'progressive resistance training']","['muscle strength and physical performance', 'HOOS subscales, knee- and hip muscle strength plus function (gait, ascending/descending stairs, and sit-to-stand', 'HOOS-ADL', 'knee strength', 'HOOS ADL']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",85.0,0.111012,No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holsgaard-Larsen', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark. Electronic address: ahlarsen@health.sdu.dk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hermann', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Department of Orthopedic Surgery, Herlev University Hospital, Denmark. Electronic address: ahermann@dadlnet.dk.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zerahn', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev University Hospital, Denmark. Electronic address: Bo.Zerahn@regionh.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mejdahl', 'Affiliation': 'Department of Orthopedic Surgery, Herlev University Hospital, Denmark. Electronic address: Steen.Mejdahl@regionh.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark. Electronic address: Soeren.Overgaard@rsyd.dk.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.04.010']
53,32383125,Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial.,"BACKGROUND


The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in December 2019 causing the coronavirus disease (COVID-19) pandemic. Currently, there is a lack of evidence-based therapies to prevent COVID-19 following exposure to the virus, or to prevent worsening of symptoms following confirmed infection. We describe the design of a clinical trial of hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET) for COVID-19.
METHODS


We will conduct two nested multicentre international double-blind randomized placebo-controlled clinical trials of hydroxychloroquine for: 1) PEP of asymptomatic household contacts or healthcare workers exposed to COVID-19 within the past four days, and 2) PET for symptomatic outpatients with COVID-19 showing symptoms for less than four days. We will recruit 1,500 patients each for the PEP and PET trials. Participants will be randomized 1:1 to receive five days of hydroxychloroquine or placebo. The primary PEP trial outcome will be the incidence of symptomatic COVID-19. The primary PET trial outcome will be an ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death). Participant screening, informed consent, and follow-up will be exclusively internet-based with appropriate regulatory and research ethics board approvals in Canada and the United States.
DISCUSSION


These complementary randomized-controlled trials are innovatively designed and adequately powered to rapidly answer urgent questions regarding the effectiveness of hydroxychloroquine to reduce virus transmission and disease severity of COVID-19 during a pandemic. In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel. Innovative trial approaches are needed to urgently assess therapeutic options to mitigate the global impact of this pandemic.
TRIALS REGISTRATION


clinicaltrials.gov (NCT04308668); registered 16 March, 2020.",2020,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'symptomatic outpatients with COVID-19 showing symptoms for less than four days', '1,500 patients each for the PEP and PET trials']","['hydroxychloroquine or placebo', 'Post-exposure prophylaxis or pre-emptive therapy', 'hydroxychloroquine', 'hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET', 'placebo']","['incidence of symptomatic COVID-19', 'ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1500.0,0.697151,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"[{'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada. slother@manitoba-physicians.ca.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Agostinis', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Infectious Diseases & Medical Microbiology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Engen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics and Child Health, Department of Pharmacology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'Critical Care Research, St-Boniface Hospital, Winnipeg, MB, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Schwartz', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'CHU de Québec - Université Laval Research Centre, Population Health and Optimal Health Practices Research Unit Trauma - Emergency - Critical Care Medicine, Université Laval, Quebec, QC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01684-7']
54,32381037,Correction to: Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden.,"Following publication of the original article [1], we were notified that one of the corresponding author's affiliations was omitted.",2020,"Following publication of the original article [1], we were notified that one of the corresponding author's affiliations was omitted.",[],['fluoxetine'],[],[],"[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]",[],,0.0426855,"Following publication of the original article [1], we were notified that one of the corresponding author's affiliations was omitted.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lundström', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Akademiska, Sjukhuset, SE-751 85, Uppsala, Sweden. erik.lundstrom@neuro.uu.se.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Isaksson', 'Affiliation': 'Department of Clinical Neuroscience, Neurology, Karolinska Institutet, Nobels väg 6, SE-171 76, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Näsman', 'Affiliation': 'Centre for Safety Research, KTH Royal Institute of Technology, TR10 B, SE-100 44, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Wester', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Mårtensson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': 'Department of Clinical Sciences, Lund, Neurology, Skåne University Hospital, Lund University, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Wallén', 'Affiliation': 'Department of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Borg', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dennis', 'Affiliation': 'Royal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Mead', 'Affiliation': 'Royal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Katharina S', 'Initials': 'KS', 'LastName': 'Sunnerhagen', 'Affiliation': 'Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04327-w']
55,32322972,[Pain physicians should not turn a blind eye: what happens when a medical product manufacturer ceases providing equipment?],,2020,,[],[],[],[],[],[],,0.032341,,"[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf, Martinistraße\xa052, 20246, Hamburg, Deutschland. a.may@uke.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Neurologische Klinik, Krankenhaus Lindenbrunn, 1120, 31861, Coppenbrügge, Deutschland.'}]","Schmerz (Berlin, Germany)",['10.1007/s00482-020-00470-0']
56,32384175,Testosterone replacement therapy: Pre-treatment sex hormone-binding globulin levels and age may identify clinical subgroups.,"BACKGROUND


Testosterone replacement therapy (TRT) improves health in some but not all men with type 2 diabetes (T2DM) and adult-onset testosterone deficiency (TD). Such heterogeneity is compatible with the concept of patient subgroups that respond differently to therapy.
OBJECTIVES


Use baseline SHBG and age to identify putative subgroups that demonstrate different responses in variables such as waist circumference and HbA1c following TRT.
MATERIALS AND METHODS


A randomized double-blind trial approach was used to recruit and randomize men with T2DM and adult-onset TD into placebo and TRT-treated groups. Multiple regression was used to study differences between groups.
RESULTS


Baseline SHBG and change in SHBG (∆SHBG) were inversely related in the TRT group. Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or>median (28.1 nmol/L, 63 years, respectively). In men with both SHBG ≤ 28.1 nmol/L and age ≤ 63 years (subgroup 1), TRT was positively associated with ∆SHBG (c = 4.67, 95%CI 1.17-8.16, P = .010) while in those with SHBG > 28.1 nmol/L and age > 63.1 years (subgroup 4) the association was inverse (c = -7.07, 95%CI -11.64 to -2.49, P = .003). The association between TRT and change (∆) in waist circumference, HbA1c and International Index of Erectile Function (IIEF) score differed between subgroups; in subgroup 4 but not subgroup 1, the therapy was significantly associated with ∆waist circumference, ∆HbA1c and ∆IIEF.
DISCUSSION


Though the mechanism remains unclear, our finding of different responses to TRT in terms of change in waist circumference, HbA1c and IIEF score supports the concept of subgroups in men with T2DM and adult-onset TD.
CONCLUSION


Our approach may provide a basis for identifying men who will or will not derive benefit from TRT though a larger study is required.",2020,"Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or >median (28.1nmol/l, 63 years respectively).","['randomise men with T2DM and adult onset TD into placebo and TRT treated groups', 'men with type 2 diabetes (T2DM) and adult onset testosterone deficiency (TD']","['Testosterone replacement therapy (TRT', 'Testosterone replacement therapy: Pre-treatment sex hormone binding globulin levels', 'TRT']","['TRT and change (∆) in waist circumference, HbA1c and International Index of Erectile Function (IIEF) score', 'waist circumference, HbA1c and IIEF score', 'Baseline SHBG and change in SHBG (∆SHBG']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1963961', 'cui_str': 'Testosterone deficiency'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.239468,"Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or >median (28.1nmol/l, 63 years respectively).","[{'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Health Sciences, University Hospitals of North Midlands, Staffordshire University, Stoke-on-Trent, UK.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Hackett', 'Affiliation': 'School of Health and Life Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Strange', 'Affiliation': 'Institute for Science and Technology in Medicine, Keele University, Keele, UK.'}]",Andrology,['10.1111/andr.12813']
57,30643223,Design and implementation of modified-texture diet in older adults with oropharyngeal dysphagia: a randomized controlled trial.,"BACKGROUND/OBJECTIVES


Oropharyngeal dysphagia (OD) is a common problem in elderly population that negatively affects the oral intake and body composition resulting in clinical complications as malnutrition and dehydration. The aim of this study was to design, implement, and evaluate the effect of texture-modified foods and thickened drinks diet, with nectar or pudding viscosity and controlled bolus volume in older adults with OD on body composition and oral intake.
SUBJECTS/METHODS


Randomized clinical trial, simple blind. Patients ≥ 65 years, admitted at a national institute, who had a confirmed diagnosis of OD were included. A texture-modified foods and thickened drinks diet, with nectar or pudding viscosity and controlled bolus volume, was compared to isocaloric standard treatment for 12 weeks. Body composition was evaluated by bioelectrical impedance, muscular functionality was evaluated by handgrip strength, and daily energy and protein intake by 24-h recall and evaluated by Food Processor Nutrition Analysis® software.
RESULTS


Twenty participants were included per group, with mean age 76 years. After 12 weeks, the consumption of energy (29 ± 10 to 40 ± 15 kcal/kg, p = 0.009) and protein (1.3 ± 0.6 to 1.8 ± 0.7 g/kg, p = 0.03), as well as phase angle (4.4 ± 1.8 to 5.5 ± 2.5°, p = 0.05), body weight (56 ± 10 to 60 ± 10 kg, p < 0.001), and handgrip strength (18 ± 11 to 21 ± 13 kg, p = 0.004) increased in the intervention group. In control group there were no changes.
CONCLUSIONS


The dietary intervention improved oral intake, weight, handgrip strength, and phase angle, which can prevent or limit the nutritional complications associated with the OD.",2019,"After 12 weeks, the consumption of energy (29 ± 10 to 40 ± 15 kcal/kg, p = 0.009) and protein (1.3 ± 0.6 to 1.8 ± 0.7 g/kg, p = 0.03), as well as phase angle (4.4 ± 1.8 to 5.5 ± 2.5°, p = 0.05), body weight (56 ± 10 to 60 ± 10 kg, p < 0.001), and handgrip strength (18 ± 11 to 21 ± 13 kg, p = 0.004) increased in the intervention group.","['65\u2009years, admitted at a national institute, who had a confirmed diagnosis of OD were included', 'Patients\u2009≥', 'older adults with OD on body composition and oral intake', 'older adults with oropharyngeal dysphagia', 'Twenty participants were included per group, with mean age 76 years']","['texture-modified foods and thickened drinks diet, with nectar or pudding viscosity', 'modified-texture diet']","['Body composition', 'oral intake, weight, handgrip strength, and phase angle, which can prevent or limit the nutritional complications', 'handgrip strength, and daily energy and protein intake', 'handgrip strength', 'consumption of energy', 'body weight']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal Dysphagia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2717960', 'cui_str': 'Nectar'}, {'cui': 'C2347717', 'cui_str': 'Pudding (substance)'}, {'cui': 'C4301986', 'cui_str': 'Viscosity (property) (qualifier value)'}, {'cui': 'C0452388', 'cui_str': 'Modified texture diet (finding)'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",20.0,0.0766473,"After 12 weeks, the consumption of energy (29 ± 10 to 40 ± 15 kcal/kg, p = 0.009) and protein (1.3 ± 0.6 to 1.8 ± 0.7 g/kg, p = 0.03), as well as phase angle (4.4 ± 1.8 to 5.5 ± 2.5°, p = 0.05), body weight (56 ± 10 to 60 ± 10 kg, p < 0.001), and handgrip strength (18 ± 11 to 21 ± 13 kg, p = 0.004) increased in the intervention group.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Reyes-Torres', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Castillo-Martínez', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Reyes-Guerrero', 'Affiliation': 'Stomatology Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Aniela G', 'Initials': 'AG', 'LastName': 'Ramos-Vázquez', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Zavala-Solares', 'Affiliation': 'Department of Gastroenterology, Motility Unit, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Cassis-Nosthas', 'Affiliation': 'Department of Food Technology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Aurora E', 'Initials': 'AE', 'LastName': 'Serralde-Zúñiga', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. aurozabeth@yahoo.com.mx.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0389-x']
58,32385676,Using an HIV Self-test Kit to Test a Partner: Attitudes and Preferences Among High-Risk Populations.,"For those most at risk of contracting HIV, new strategies for preventing transmission and increasing testing are needed. As part of a multi-site, randomized, controlled trial, we explored attitudes and preferences among 272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners. Less than one quarter had previously self-tested with HIVST kits (21.7%) and few had partner-tested (4.8%). Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%). Five percent reported difficulties performing the test, four percent with storage, and 26% with portability. Ninety-three percent reported likelihood of using HIVST to test partners in future, but only 3% were willing to pay the current price. Efforts to improve HIVST uptake should focus on incorporating testing for other STIs, reducing test kit size, and reducing cost.",2020,"Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%).",['272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners'],[],[],"[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",[],[],272.0,0.0162985,"Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA. sjiribar@uw.edu.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tagliaferri Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02885-3']
59,32386811,Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial.,"PURPOSE


To compare best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK).
DESIGN


Prospective, multicenter randomized controlled trial.
PARTICIPANTS


Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands.
METHODS


Participants were allocated to DMEK (n = 29) or UT-DSAEK (n = 25) using minimization randomization based on preoperative BSCVA, recipient central corneal thickness, gender, age, and institution. Donor corneas were prestripped and precut for DMEK and UT-DSAEK, respectively. Six corneal surgeons participated in this study.
MAIN OUTCOME MEASURES


The primary outcome measure was BSCVA at 12 months after surgery.
RESULTS


Central graft thickness of UT-DSAEK lamellae measured 101 μm (95% confidence interval [CI], 90-112 μm). Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR] [95% CI 0.08-0.22 logMAR] vs. 0.22 logMAR [95% CI 0.16-0.27 logMAR]; P = 0.15), 6 months (0.11 logMAR [95% CI 0.05-0.17 logMAR] vs. 0.16 logMAR [95% CI 0.12-0.21 logMAR]; P = 0.20), and 12 months (0.08 logMAR [95% CI 0.03-0.14 logMAR] vs. 0.15 logMAR [95% CI 0.10-0.19 logMAR]; P = 0.06). Twelve months after surgery, the percentage of eyes reaching 20/25 Snellen BSCVA was higher in DMEK compared with UT-DSAEK (66% vs. 33%; P = 0.02). Endothelial cell density did not differ significantly 12 months after DMEK and UT-DSAEK (1870 cells/mm 2  [95% CI 1670-2069 cells/mm 2 ] vs. 1612 cells/mm 2  [95% CI 1326-1898 cells/mm 2 ]; P = 0.12). Both techniques induced a mild hyperopic shift (12 months: +0.22 diopter [D; 95% CI -0.23 to 0.68 D] for DMEK vs. +0.58 D [95% CI 0.13-1.03 D] for UT-DSAEK; P = 0.34).
CONCLUSIONS


Descemet membrane endothelial keratoplasty and UT-DSAEK did not differ significantly in mean BSCVA, but the percentage of eyes achieving 20/25 Snellen vision was significantly higher with DMEK. Endothelial cell loss did not differ significantly between the treatment groups, and both techniques induced a minimal hyperopic shift.",2020,Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR],"['Six corneal surgeons participated in this study', 'Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands', 'Participants were allocated to DMEK (n\xa0= 29) or']","['UT-DSAEK', 'Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty']","['Endothelial cell loss', 'mild hyperopic shift', 'Best spectacle-corrected visual acuity', 'BSCVA at 12 months after surgery', 'percentage of eyes achieving 20/25 Snellen vision', 'percentage of eyes reaching 20/25 Snellen BSCVA', 'spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK', 'Endothelial cell density']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0016781', 'cui_str': ""Fuchs' corneal dystrophy""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}]","[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}]","[{'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690939', 'cui_str': '20/25'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}]",54.0,0.324218,Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR],"[{'ForeName': 'Suryan L', 'Initials': 'SL', 'LastName': 'Dunker', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address: suryan.dunker@mumc.nl.'}, {'ForeName': 'Mor M', 'Initials': 'MM', 'LastName': 'Dickman', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Ophthalmology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Robert P L', 'Initials': 'RPL', 'LastName': 'Wisse', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Nobacht', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert H J', 'Initials': 'RHJ', 'LastName': 'Wijdh', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marjolijn C', 'Initials': 'MC', 'LastName': 'Bartels', 'Affiliation': 'Department of Ophthalmology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Mei L', 'Initials': 'ML', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology, Gelre Hospitals, Apeldoorn, The Netherlands.'}, {'ForeName': 'Frank J H M', 'Initials': 'FJHM', 'LastName': 'van den Biggelaar', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Kruit', 'Affiliation': 'Euro Tissue Bank - Bio Implant Service (ETB-BISLIFE), Leiden, The Netherlands.'}, {'ForeName': 'Rudy M M A', 'Initials': 'RMMA', 'LastName': 'Nuijts', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Ophthalmology, Zuyderland Medical Center, Heerlen, The Netherlands.'}]",Ophthalmology,['10.1016/j.ophtha.2020.02.029']
60,32398580,Transverse vs. parasagittal in-plane approaches in ultrasound-guided paravertebral block using a microconvex probe: A randomised controlled trial.,"BACKGROUND


Several approaches have been proposed for ultrasound-guided thoracic paravertebral block, but the best approach remains unclear.
OBJECTIVE


We compared two ultrasound-guided in-plane approaches using a microconvex probe, transverse and parasagittal. We assessed whether either approach would facilitate successful catheter placement in the paravertebral space.
DESIGN


Randomised controlled trial.
SETTING


University hospital, July 2015 to March 2016.
PATIENTS


Sixty patients scheduled to undergo thoracotomy were randomly allocated into two groups.
INTERVENTIONS


A microconvex probe was placed transversely between adjacent ribs (transverse) or sagittally between adjacent transverse processes (parasagittal). When the Tuohy needle reached the paravertebral space, a catheter was inserted to a depth of 4 cm. Then, 0.5-ml radiocontrast was injected through the catheter under fluoroscopy.
MAIN OUTCOME MEASURES


The primary outcome was successful catheter placement in the paravertebral space; secondary outcomes were 0 to 100 mm visual analogue scale pain score and morphine consumption in the first 24 h.
RESULTS


All patients received the allocated paravertebral block. Correct catheter placement occurred in 23 (77%) and 24 patients (80%) using the transverse (n=30) and parasagittal approaches (n=30), respectively (P = 1.00). Five patients were excluded due to changes in surgical procedure. Postoperative pain, represented by median [IQR] visual analogue scale score, was 19.5 [12 to 25] at rest and 55 [44 to 77] on movement with the transverse approach (n=28) vs. 22 [12 to 33.5] at rest and 59 [41.5 to 75] on movement with the parasagittal approach (n=27) (P = 0.57 at rest, P = 0.76 on movement). Median morphine consumption was 11.5 [5 to 21] and 11 [5 to 18] mg in the transverse and parasagittal approaches, respectively (P = 0.99).
CONCLUSION


There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
TRIAL REGISTRATION


UMIN Clinical Trials Registry identifier: UMIN000015988.",2020,"There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
","['University hospital, July 2015 to March 2016', 'Sixty patients scheduled to undergo thoracotomy']",[],"['Median morphine consumption', 'successful catheter placement in the paravertebral space; secondary outcomes were 0 to 100\u200amm visual analogue scale pain score and morphine consumption', 'Correct catheter placement', 'Postoperative pain', 'median [IQR] visual analogue scale score']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",5.0,0.212423,"There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Anaesthesiology, Nagoya University Graduate School of Medicine (TF, KN), Department of Surgical Center (YS) and Department of Anaesthesiology, Nagoya University Hospital, Nagoya, Japan (SS).'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': ''}, {'ForeName': 'Sonoe', 'Initials': 'S', 'LastName': 'Shinya', 'Affiliation': ''}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001223']
61,32398581,"Prophylactic norepinephrine infusion or leg wrapping for postspinal hypotension in elective caesarean delivery: A randomised, double-blind, placebo-controlled trial.","BACKGROUND


Because of its alpha and beta agonist properties, norepinephrine infusion is currently being studied for the prevention of spinal hypotension during caesarean delivery. Vasopressor infusions are not always possible if there is an unavailability of infusion pumps. Leg wrapping with crepe bandage is an effective technique for prevention of postspinal hypotension and could be useful in resource-poor settings.
OBJECTIVE


The aim of this study was to compare the incidence of hypotension with norepinephrine infusion or leg wrapping with a control group in women undergoing caesarean delivery with spinal anaesthesia.
DESIGN


Randomised, double-blind, controlled trial.
SETTING


Single centre, tertiary level institute, India.Study period 3 April 2018 to 31 March 2019.
PATIENTS


One hundred and forty-four women aged 19 to 40 years with a singleton pregnancy.
INTERVENTION


In group Leg Wrapping, crepe bandage was applied tightly from metatarsus to groin. Group Norepinephrine and the control group received sham leg wrapping. In group Norepinephrine, the women received a norepinephrine infusion according to their body weight, while group Leg Wrapping and the control group received a 0.9% normal saline infusion at a similar rate. All three groups received a 500 ml co-load of Ringer's solution over 15 min. Noninvasive SBP was monitored every 2 min until delivery, and every 5 min thereafter. Any hypotensive event (SBP < 20% of baseline) was treated with an intravenous bolus of norepinephrine (7.5 μg).
MAIN OUTCOME MEASURES


The primary outcome was the incidence of hypotension. The secondary outcomes were performance error measurements, and the incidences of hypertension, bradycardia, norepinephrine rescue bolus and neonatal outcomes.
RESULTS


The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both). Performance error calculations showed that SBP was maintained closer to baseline with the norepinephrine infusion.
CONCLUSION


Norepinephrine infusion and leg wrapping can both reduce the incidence of postspinal hypotension during elective caesarean delivery compared with saline infusion alone.
TRIAL REGISTRATION


Clinical trial number and registry URL: CTRI/2018/04/012917 registered at Clinical Trial Registry of India http://www.ctri.nic.in/Clinicaltrials/login.php.",2020,The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both).,"['Study period 3 April 2018 to 31 March 2019', 'postspinal hypotension in elective caesarean delivery', 'Single centre, tertiary level institute, India', 'One hundred and forty-four women aged 19 to 40 years with a singleton pregnancy', 'women undergoing caesarean delivery with spinal anaesthesia']","['saline infusion alone', 'norepinephrine infusion', 'Prophylactic Norepinephrine infusion and Leg Wrapping', 'Norepinephrine', ""500\u200aml co-load of Ringer's solution"", 'Vasopressor infusions', 'Leg wrapping with crepe bandage', 'norepinephrine', 'sham leg wrapping', 'normal saline infusion', 'norepinephrine infusion or leg wrapping with a control group', 'placebo']","['postspinal hypotension', 'Noninvasive SBP', 'incidence of hypotension', 'performance error measurements, and the incidences of hypertension, bradycardia, norepinephrine rescue bolus and neonatal outcomes', 'incidences of hypotension']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0445414', 'cui_str': 'Wrapping'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0460462', 'cui_str': 'Cotton crepe bandage'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",144.0,0.410984,The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both).,"[{'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Sundararajan', 'Affiliation': 'From the Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed University), Puducherry, India (MS, CR, RP, RM).'}, {'ForeName': 'Charulatha', 'Initials': 'C', 'LastName': 'Ravindran', 'Affiliation': ''}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Ponnusamy', 'Affiliation': ''}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Murugesan', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001231']
62,32399662,Empagliflozin attenuates neointimal hyperplasia after drug-eluting-stent implantation in patients with type 2 diabetes.,"The effects of empagliflozin, a sodium-glucose co-transporter 2 inhibitor, on neointimal response after drug-eluting-stent (DES) implantation remains unknown. Insufficiently controlled diabetes patients with coronary artery disease planned for DES stenting were consecutively enrolled. The patients were assigned to receive empagliflozin in addition to standard therapy or intensive therapy using other glucose-lowering drugs (oGLD). The primary endpoint was thickness of neointimal hyperplasia (NIH) 12 months after stenting assessed by optical coherence tomography (OCT). A total of 28 patients were analyzed (n = 15 in the empagliflozin group, n = 13 in the oGLD group). The levels of glucose profile were not significantly different between both groups at follow-up [HbA1c; 7.2 ± 0.8 vs 7.3 ± 0.9%, p = 0.46]. In OCT analysis, neointima was significantly less in the empagliflozin group than the oGLD group [mean NIH thickness: 137 ± 32 vs 168 ± 39 μm, p = 0.02]. Changes of systolic and diastolic blood pressure (BP), changes of body mass index, and changes of hematocrit after additional treatment were significantly associated with NIH attenuation, whereas no correlation was observed in changes in blood glucose parameters. Multivariate logistic regression analysis revealed that changes in systolic BP was the strongest predictor for NIH attenuation, followed by changes in diastolic BP. In patients with type 2 diabetes, standard plus empagliflozin attenuated neointimal progression as compared with intensive standard therapy after DES implantation. Our data possibly support a beneficial effect of empagliflozin in type 2 diabetes required for coronary revascularization therapy.",2020,"In OCT analysis, neointima was significantly less in the empagliflozin group than the oGLD group","['Insufficiently controlled diabetes patients with coronary artery disease planned for DES stenting were consecutively enrolled', '28 patients were analyzed (n\u2009=\u200915 in the empagliflozin group, n\u2009=\u200913 in the oGLD group', 'patients with type 2 diabetes']","['Empagliflozin', 'empagliflozin in addition to standard therapy or intensive therapy using other glucose-lowering drugs (oGLD', 'oGLD', 'empagliflozin']","['neointimal progression', 'diastolic BP', 'neointimal hyperplasia', 'Changes of systolic and diastolic blood pressure (BP), changes of body mass index, and changes of hematocrit', 'systolic BP', 'neointimal response', 'levels of glucose profile', 'blood glucose parameters', 'thickness of neointimal hyperplasia (NIH) 12\xa0months after stenting assessed by optical coherence tomography (OCT']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4049446', 'cui_str': 'Neointimal hyperplasia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",28.0,0.0256448,"In OCT analysis, neointima was significantly less in the empagliflozin group than the oGLD group","[{'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Hashikata', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan. t_hashikata@med.kitasato-u.ac.jp.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Ikutomi', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Jimba', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Shindo', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Kakuda', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Katsushika', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Kishi', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Masashiro', 'Initials': 'M', 'LastName': 'Matsushita', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01621-0']
63,32334592,"Comparison of the effects of twice-daily exenatide and insulin on carotid intima-media thickness in type 2 diabetes mellitus patients: a 52-week randomized, open-label, controlled trial.","BACKGROUND


Exenatide, a glucagon like peptide 1 analog, has been suggested to reduce the cardiovascular disease risk factors, such as body weight, blood pressure and subclinical atherosclerosis in patients with type 2 diabetes mellitus (T2DM). This was the first randomized, open-label, controlled trial to compare the effects of exenatide versus insulin on subclinical atherosclerosis, as assessed by carotid-intima media thickness (CIMT), in patients with T2DM.
METHODS


A total of 66 patients with T2DM admitted from March 10, 2015 to June 20, 2017 in the Department of Endocrinology, Beijing Hospital were randomized to receive twice-daily exenatide or aspartate 70/30 insulin for 52 weeks. The primary endpoint was change from baseline in CIMT, and secondary endpoints included changes at week 52 from baseline in body weight, glycemic markers, lipid metabolism markers, blood pressure, C-reactive protein, fibrinogen, 8-hydroxydeoxyguanosine, irisin, and brain natriuretic peptide.
RESULTS


Exenatide more significantly reduced the CIMT from baseline compared with insulin after 52 weeks, with a mean difference of - 0.14 mm (95% interval confidence: - 0.25, - 0.02; P = 0.016). Weight and body mass index were both significantly reduced in the exenatide group over 52 weeks. Exenatide reduced total lipoprotein and low-density lipoprotein cholesterol levels more significantly than insulin at weeks 16 and 40. Correlation analyses showed that CIMT was positively correlated with low-density lipoprotein cholesterol.
CONCLUSIONS


Twice-daily exenatide could prevent atherosclerosis progression in patients with T2DM over a 52-week treatment period compared with insulin therapy. Trial registration Chinese Clinical Trial Registry ChiCTR-1800015658.",2020,Exenatide reduced total lipoprotein and low-density lipoprotein cholesterol levels more significantly than insulin at weeks 16 and 40.,"['type 2 diabetes mellitus patients', 'patients with T2DM', '66 patients with T2DM admitted from March 10, 2015 to June 20, 2017 in the Department of Endocrinology, Beijing Hospital', 'patients with type 2 diabetes mellitus (T2DM']","['exenatide versus insulin', 'exenatide', 'exenatide or aspartate 70/30 insulin', 'twice-daily exenatide and insulin', 'Exenatide']","['CIMT', 'atherosclerosis progression', 'Weight and body mass index', 'change from baseline in CIMT', 'body weight, glycemic markers, lipid metabolism markers, blood pressure, C-reactive protein, fibrinogen, 8-hydroxydeoxyguanosine, irisin, and brain natriuretic peptide', 'total lipoprotein and low-density lipoprotein cholesterol levels', 'carotid intima-media thickness', 'low-density lipoprotein cholesterol']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",66.0,0.3004,Exenatide reduced total lipoprotein and low-density lipoprotein cholesterol levels more significantly than insulin at weeks 16 and 40.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Graduate School of Peking Union Medical College, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China.'}, {'ForeName': 'Tong-Zhang', 'Initials': 'TZ', 'LastName': 'Xian', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China.'}, {'ForeName': 'Ming-Xiao', 'Initials': 'MX', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pan', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. panqi621@126.com.'}, {'ForeName': 'Li-Xin', 'Initials': 'LX', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Graduate School of Peking Union Medical College, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. glx1218@163.com.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01014-7']
64,32328440,Internet-based self-help intervention aimed at increasing social self-efficacy among internal migrants in Poland: Study protocol for a randomized controlled trial.,"Background


Migration is a challenging life transition that may be a source of various problems related to well-being and mental health. However, the psychological adaptation of migrants may be potentially facilitated by social self-efficacy-the beliefs in one's ability to initiate and maintain interpersonal relationships. Previous research suggests that social self-efficacy is positively related to adjustment and negatively related to loneliness, depression, and psychological distress. Research also confirms that self-efficacy beliefs can be effectively enhanced using Internet-based interventions. These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to sources of self-efficacy beliefs: mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states. Users complete increasingly challenging tasks that encourage them to interact with their environment. The aim of this trial was to investigate the efficacy of the New in Town intervention.
Methods


The efficacy of the New in Town intervention will be tested in a two-arm randomized controlled trial with a waitlist control group. Social self-efficacy will be the primary outcome. Secondary outcomes will include loneliness, perceived social support, and satisfaction with life. Additionally, we will measure user experience among participants allocated to the experimental group. We aim to recruit a total of  N  = 280 participants aged at least 18 years who have changed their place of residence in the last 6 months and have an Internet connection. Participants will be assessed at baseline, 3-week post-test, and 8-week follow-up.
Discussion


The trial will provide insights into the efficacy of Internet-based self-help interventions in increasing social self-efficacy. Given that the intervention works, New in Town could provide an easily accessible support option for internal migrants in Poland.
Trial registration


The trial was registered with ClinicalTrials.gov (identifier: NCT04088487) on 11th September 2019.",2020,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.",['total of  N \u202f=\u202f280 participants aged at least 18\u202fyears who have changed their place of residence in the last 6\u202fmonths and have an Internet connection'],"['Internet-based self-help intervention', 'Internet-based self-help interventions']","['Social self-efficacy', 'loneliness, perceived social support, and satisfaction with life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",280.0,0.0703208,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rogala', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Szczepaniak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Internet interventions,['10.1016/j.invent.2020.100322']
65,32391709,"Single-session digital intervention for adolescent depression, anxiety, and well-being: Outcomes of a randomized controlled trial with Kenyan adolescents.","BACKGROUND


Adolescent depression and anxiety symptoms are prevalent in sub-Saharan African countries, yet treatment options are scarce, and stigma limits help-seeking. Brief, computerized single-session interventions (SSIs) that contain empirically supported stigma-reducing elements may help expand access to treatment. We developed and evaluated such an intervention for Kenyan adolescents.
METHOD


High school students (N = 103, age 13-18) were randomized to a digital SSI Shamiri-Digital (Shamiri means ""thrive"" in Kiswahili) or a study-skills control intervention. Shamiri-Digital consisted of reading and writing activities about 3 concepts: growth mindset, gratitude, and value affirmation. Both Shamiri-Digital and the study-skills control condition were delivered electronically in schools.
RESULTS


Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up. The effects exceed the mean effects reported in meta-analyses of full-length, face-to-face psychotherapy for youth depression. There were no significant effects on anxiety symptoms, well-being, or happiness.
CONCLUSION


This is the first report that a brief, computerized SSI may reduce depressive symptoms in adolescents in sub-Saharan Africa. Replication trials with extended follow-ups will help gauge the strength and durability of these effects. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","['Kenyan adolescents', 'High school students (N = 103, age 13-18', 'adolescents in sub-Saharan Africa']","['computerized SSI', 'digital SSI Shamiri-Digital (Shamiri means ""thrive"" in Kiswahili) or a study-skills control intervention', 'Single-session digital intervention', 'computerized single-session interventions (SSIs']","['severe depression symptoms', 'anxiety symptoms, well-being, or happiness', 'depressive symptoms', 'adolescent depressive symptoms']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0872907,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","[{'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Osborn', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, University of Pennsylvania.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Rediet G', 'Initials': 'RG', 'LastName': 'Alemu', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Roe', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Arango G', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Benny H', 'Initials': 'BH', 'LastName': 'Otieno', 'Affiliation': 'Shamiri Institute.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wasanga', 'Affiliation': 'Department of Psychology, Kenyatta University.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shingleton', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000505']
66,32335963,Effects of active commuting on cardiovascular risk factors: GISMO-a randomized controlled feasibility study.,"A sedentary lifestyle is a major modifiable risk factor for many chronic diseases. Lifestyle modification in order to increase exercise capacity is key in the prevention and rehabilitation of chronic diseases. This could be achieved by active commute. The aim of this study was to assess the effects of daily active commuting on physical activity (PA) and exercise capacity. Seventy-three healthy hospital employees (age: 46 ± 9 years, 38% male), with a predominantly passive way of commuting, were randomly assigned to two parallel groups, a control group (CG, N = 22) or an intervention group (IG, N = 51), which was further split into public transportation/active commuting (IG-PT, N = 25) and cycling (IG-C, N = 26). Both intervention groups were asked to reach 150 min/wk of moderate- to vigorous-intensity exercise during their commute for 1 year. CG maintained a passive commuting mode. All participants underwent assessment of anthropometry, risk factor stratification, and exercise capacity by a medical doctor at the Institute of Sports Medicine, Prevention and Rehabilitation. Weekly physical activity, using the International Physical Activity Questionnaire and commuting behavior, using an online diary, were used to assess physical activity. At the end of the study, the change in exercise capacity did significantly differ between IG and CG (P = .003, ES = 0.82). Actively covered distances through commuting significantly differed between groups (walking P = .026; cycling P < .001). Therefore, active commuting improves exercise capacity and can be recommended to the working population to increase exercise capacity.",2020,Actively covered distances through commuting significantly differed between groups (walking p=0.026; cycling p<0.001).,"['73 healthy hospital employees (age: 46±9 years, 38% males), with a predominantly passive way of commuting', 'All participants underwent assessment of anthropometry, risk factor stratification and exercise capacity by a medical doctor at the Institute of preventive and rehabilitative Sports Medicine']","['moderate-vigorous intensity exercise', 'active commuting', 'control group (CG, N=22) or an intervention group (IG, N=51) which was further split into public transportation/active commuting (IG-PT']","['cardiovascular risk factors', 'change in exercise capacity', 'physical activity (PA) and exercise capacity']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",73.0,0.0486887,Actively covered distances through commuting significantly differed between groups (walking p=0.026; cycling p<0.001).,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reich', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Loidl', 'Affiliation': 'Department of Geoinformatics, Paris Lodron University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Fernandez La Puente de Battre', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Valentina Alice', 'Initials': 'VA', 'LastName': 'Rossi', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Zagel', 'Affiliation': 'Department of Geoinformatics, Paris Lodron University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Caselli', 'Affiliation': 'Cardiovascular Center Zürich, Hirslanden Klinik im Park, Zürich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmied', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13697']
67,30514879,Effects of intermittent versus continuous energy restriction for weight loss on diet quality and eating behavior. A randomized trial.,"BACKGROUND/OBJECTIVES


Weight loss diets affect food choices and control of eating. We evaluated the effects of intermittent energy restriction (IER) vs. continuous energy restriction (CER) on nutritional composition and eating behavior.
SUBJECT/METHODS


Individuals with BMI 30-45 kg/m 2 , abdominal obesity and ≥1 additional metabolic syndrome component were randomized to IER vs. CER with similar energy restriction. Of 112 participants, 98 completed weighed dietary records and the Three Factor Eating Questionnaire at baseline and three months. In statistical analysis, changes were adjusted for baseline values.
RESULTS


Weight loss, energy intake, and macronutrient composition were similar in the IER and CER groups. The CER group reported a greater increase in fruit and berries (45 g/day [95% CI 21, 71] vs. 2 g/day [-28, 33]; p = 0.047) and vegetables (135 g/day [91, 179] vs. 65 g/day [35, 96]; p = 0.010) than the IER group. Fiber intake increased in the CER compared to the IER group (1.0 g/MJ/day [0.8, 1.2] vs. 0.2 [0.0, 0.4]; p < 0.001). Sugar intake was reduced in the CER compared to the IER group (-2.2E% [-3.2, -2.2] vs. -0.1E% [-1.2, 1.0]; p = 0.007). Intakes of folate, potassium, and magnesium decreased more in the IER than the CER group, while vitamin C increased more in the CER group (all p-values <0.014). Both diets improved eating behavior scores, but cognitive restraint increased more in the CER than the IER group (34 [30, 39] vs. 17 [12, 22]; p = 0.013).
CONCLUSIONS


Men and women with obesity had more favorable changes in nutritional composition and eating behavior with CER than IER.",2019,"Sugar intake was reduced in the CER compared to the IER group (-2.2E% [-3.2, -2.2] vs. -0.1E% [-1.2, 1.0]; p = 0.007).","['Individuals with BMI 30-45\u2009kg/m 2 , abdominal obesity and ≥1 additional metabolic syndrome component', 'Of 112 participants, 98 completed weighed dietary records and the Three', 'Men and women with obesity']","['intermittent versus continuous energy restriction', 'intermittent energy restriction (IER) vs. continuous energy restriction (CER', 'IER vs. CER with similar energy restriction']","['vitamin C', 'diet quality and eating behavior', 'nutritional composition and eating behavior', 'fruit and berries', 'Intakes of folate, potassium, and magnesium', 'Fiber intake', 'Sugar intake', 'eating behavior scores', 'cognitive restraint', 'CER', 'Factor Eating Questionnaire', 'Weight loss, energy intake, and macronutrient composition']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]",,0.0466005,"Sugar intake was reduced in the CER compared to the IER group (-2.2E% [-3.2, -2.2] vs. -0.1E% [-1.2, 1.0]; p = 0.007).","[{'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Sundfør', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway. tinsun@ous-hf.no.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tonstad', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Svendsen', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0370-0']
68,31467314,Role of fundoplication in treatment of patients with symptoms of hiatal hernia.,"Gastroesophageal reflux disease (GERD) is often associated with hiatal hernia (HH). However, the need for fundoplication during hiatal hernia repair (HHR) remains controversial. The objective of this study was to evaluate the effect of HHR with concomitant laparoscopic Nissen fundoplication (HHR-LNF) in HH patients. A total of 122 patients with symptomatic HH were randomized to receive either HHR (n = 61) or HHR-LNF (n = 61). The measures of evaluating outcomes included DeMeester scores (DMS), complications, Reflux Diagnostic Questionnaire and patients' satisfaction 24 months following surgery. Despite comparable values in both groups at randomization, the DMS, total numbers of reflux episodes and percentage of time with pH < 4 were significantly higher in HHR group than in HHR-LNF group (P = 0.017, P = 0.002 and P = 0.019, respectively) at 6 months after surgery. One months postoperatively, complications were higher in the HHR-LNF group than in the HHR group (all P < 0.001), and there was no difference between the two groups at 6 months. By the end of the 2-year follow-up, HHR-LNF group showed a significantly lower reflux syndrome frequency-intensity score and greater percentage of satisfaction compared with HHR group (all P < 0.001). Laparoscopic HHR should be combined with a fundoplication in GERD patients with HH. HHR-LNF is safe and effective, not only improve reflux-related symptom, but also reduce the incidence of complications.",2019,"One months postoperatively, complications were higher in the HHR-LNF group than in the HHR group (all P < 0.001), and there was no difference between the two groups at 6 months.","['122 patients with symptomatic HH', 'Gastroesophageal reflux disease (GERD', 'patients with symptoms of hiatal hernia', 'HH patients', 'GERD patients with HH']","['HHR', 'Laparoscopic HHR', 'fundoplication', 'HHR-LNF', 'HHR with concomitant laparoscopic Nissen fundoplication (HHR-LNF']","[""DeMeester scores (DMS), complications, Reflux Diagnostic Questionnaire and patients' satisfaction 24 months following surgery"", 'reflux syndrome frequency-intensity score and greater percentage of satisfaction', 'DMS, total numbers of reflux episodes and percentage of time with pH\u2009<\u20094', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}]","[{'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",122.0,0.0554797,"One months postoperatively, complications were higher in the HHR-LNF group than in the HHR group (all P < 0.001), and there was no difference between the two groups at 6 months.","[{'ForeName': 'Zhi-Tong', 'Initials': 'ZT', 'LastName': 'Li', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China. jifenggreat@126.com.""}, {'ForeName': 'Xin-Wei', 'Initials': 'XW', 'LastName': 'Han', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China. xinweihanvip@126.com.""}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Yuan', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Zheng-Yang', 'Initials': 'ZY', 'LastName': 'Wu', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'De-Lu', 'Initials': 'DL', 'LastName': 'Peng', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Zhong-Gao', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}]",Scientific reports,['10.1038/s41598-019-48740-x']
69,31721277,"Safety and Efficacy of Otaplimastat in Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study.","OBJECTIVE


Otaplimastat is a neuroprotectant that inhibits matrix metalloprotease pathway, and reduces edema and intracerebral hemorrhage induced by recombinant tissue plasminogen activator (rtPA) in animal stroke models. We aimed to assess the safety and efficacy of otaplimastat in patients receiving rtPA.
METHODS


This was a phase 2, 2-part, multicenter trial in stroke patients (19-80 years old) receiving rtPA. Intravenous otaplimastat was administered <30 minutes after rtPA. Stage 1 was a single-arm, open-label safety study in 11 patients. Otaplimastat 80 mg was administered twice daily for 3 days. Stage 2 was a randomized, double-blind, placebo-controlled study involving 69 patients, assigned (1:1:1) to otaplimastat 40 mg, otaplimastat 80 mg, or a placebo. The primary endpoint was the occurrence of parenchymal hematoma (PH) on day 1. Secondary endpoints included serious adverse events (SAEs), mortality, and modified Rankin scale (mRS) distribution at 90 days (clinicaltrials.gov identifier: NCT02787278).
RESULTS


No safety issues were encountered in stage 1. The incidence of PH during stage 2 was comparable: 0 of 22 with the placebo, 0 of 22 with otaplimastat 40 mg, and 1 of 21 with the 80 mg dose. No differences in SAEs (13%, 17%, 14%) or death (8.3%, 4.2%, 4.8%) were observed among the 3 groups. Three adverse events (chills, muscle rigidity, hepatotoxicity) were judged to be related to otaplimastat.
INTERPRETATION


Intravenous otaplimastat adjunctive therapy in patients receiving rtPA is feasible and generally safe. The functional efficacy of otaplimastat needs to be investigated with further large trials. ANN NEUROL 2020;87:233-245.",2020,"Three adverse events (chills, muscle rigidity, hepatotoxicity) were judged to be related to otaplimastat.
","['Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA', 'stroke patients (19-80\u2009years) receiving', 'patients receiving rtPA', '69 patients']","['Placebo', 'Otaplimastat', 'otaplimastat 40 mg, 80 mg or a placebo', 'rtPA', 'placebo', 'recombinant tissue plasminogen activator (rtPA']","['death', 'incidence of PH', 'SAE', 'adverse events (chills, muscle rigidity, hepatotoxicity', 'Safety and Efficacy', 'serious adverse events (SAE), mortality, and modified Rankin scale (mRS) distribution', 'safety and efficacy', 'occurrence of parenchymal hematoma (PH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",69.0,0.507934,"Three adverse events (chills, muscle rigidity, hepatotoxicity) were judged to be related to otaplimastat.
","[{'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'Kyung Bok', 'Initials': 'KB', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Soonchunhyang University School of Medicine, Seoul.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Myongji Hospital, Hanyang University College of Medicine, Goyang.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Sung', 'Affiliation': 'Department of Neurology, Pusan National University Hospital, Busan.'}, {'ForeName': 'Kyungmi', 'Initials': 'K', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Korea University Guro Hospital, Seoul.'}, {'ForeName': 'Eung-Gyu', 'Initials': 'EG', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Inje University Busan Paik Hospital, Busan.'}, {'ForeName': 'Dae-Il', 'Initials': 'DI', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Kyung Hee University Hospital, Seoul.'}, {'ForeName': 'Yang Ha', 'Initials': 'YH', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurology, Kyungpook National University School of Medicine and Hospital, Daegu.'}, {'ForeName': 'Eun-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'Won-Ki', 'Initials': 'WK', 'LastName': 'Kim', 'Affiliation': 'Department of Neuroscience, Korea University College of Medicine, Seoul.'}, {'ForeName': 'Chung', 'Initials': 'C', 'LastName': 'Ju', 'Affiliation': 'Research Headquarters, Shin Poong Pharmaceutical, Ansan, Korea.'}, {'ForeName': 'Byung Su', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Research Headquarters, Shin Poong Pharmaceutical, Ansan, Korea.'}, {'ForeName': 'Jei-Man', 'Initials': 'JM', 'LastName': 'Ryu', 'Affiliation': 'Research Headquarters, Shin Poong Pharmaceutical, Ansan, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25644']
70,32387326,The influence of postoperative environment on patient pain and satisfaction: a randomized trial.,"BACKGROUND


Improving the patient experience, controlling pain with nonopiate therapies, and preparing for value-based reimbursement are increasingly important foci for both physicians and hospitals.
OBJECTIVE


We aimed to determine whether the addition of music and a natural landscape image to postoperative hospital rooms would result in improved pain and satisfaction scores among inpatients undergoing pelvic reconstructive surgery.
STUDY DESIGN


This randomized controlled trial was approved by an Institutional Review Board. Eligible candidates were 18-85 years old, English speaking, and scheduled to undergo native tissue vaginal vault suspension for symptomatic pelvic organ prolapse. Patients with history of a chronic pain or substance abuse were excluded. Subjects were advised that the purpose of the study was to assess the effect of changes to the hospital environment on patient experience but were blinded to their group and intervention details. Changes included a landscape image mounted to the wall and access to a speaker with preprogrammed music selections. The intervention group was instructed to listen to their preferred music for a minimum of 2 30-minute sessions postoperatively. The control group had a standard hospital room, without music or landscape. All patient rooms were private. The primary outcome was the visual analog scale for pain in the morning of postoperative day 1. Secondary outcomes included narcotic use, likelihood to refer family to the same hospital facility, satisfaction with care and the hospital, and perception of a healing environment. A sample size of 43 subjects per arm was calculated to detect a difference of 10 mm in visual analog scale pain score.
RESULTS


A total of 133 subjects were enrolled; primary outcome data were available for 92 (46 per arm). The mean age was 63.8 (standard deviation, 9.5) years, median Charlson comorbidity score was 2 (min, 0; max, 7), and 94.6% of subjects were white. On postoperative day 1, median visual analog scale pain scores were low (28.8 mm [0, 86]; 24.5 mm [0, 81]) and did not differ between intervention and control, respectively (P=.57). Total morphine equivalents (P=.817) and nursing pain scores (P=.774) were also similar. However, the intervention group displayed a higher likelihood to refer family members to the hospital (98 mm (47, 100); 96 mm (65, 100); P=.037). At postoperative 2 weeks, the intervention group indicated higher satisfaction with their care (98 mm, (34, 100); 95 mm (42, 100); P=.032), the hospital (98 mm (71, 100); 94 mm (6, 100); P=.004), and the healing environment provided during their stay (98 mm; 92 mm (19, 100); P=.020) than those in the standard hospital rooms.
CONCLUSION


In this randomized trial, we found music and landscape imagery did not substantially affect postoperative pain scores; however, they had a positive effect on the postoperative experience. Furthermore, this effect appeared to broaden 2 weeks after surgery. Given the importance of value-based care, interventions such as these should be emphasized to enhance patient satisfaction, quality scores, and overall well-being.",2020,Total morphine equivalents (p=0.817) and nursing pain scores (p=0.774) were also similar.,"['One hundred thirty-three subjects were enrolled; primary outcome data was available for 92 (46 per arm', 'The mean age was 63.8 (SD 9.5) years, median Charlson Comorbidity score was 2 (min=0,max=7), and 94.6% were Caucasian', 'inpatients undergoing pelvic reconstructive surgery', 'Exclusions included history of a chronic pain or substance abuse', 'Eligible candidates were 18-85 years old, English speaking, and scheduled to undergo native tissue vaginal vault suspension for symptomatic pelvic organ prolapse']","['standard hospital room, without music or landscape', 'Postoperative Environment']","['VAS pain score', 'Total morphine equivalents', 'healing environment', 'nursing pain scores', 'narcotic use, likelihood to refer family to the same hospital facility, satisfaction with care and the hospital, and perception of a healing environment', 'Patient Pain and Satisfaction', 'higher satisfaction with their care', 'Visual Analogue Scale (VAS) for pain on the morning of post-operative day one', 'pain and satisfaction scores', 'median VAS scores for pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0227794', 'cui_str': 'Structure of fornix of vagina'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",133.0,0.174362,Total morphine equivalents (p=0.817) and nursing pain scores (p=0.774) were also similar.,"[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH. Electronic address: austinm.hill1@gmail.com.'}, {'ForeName': 'Catrina C', 'Initials': 'CC', 'LastName': 'Crisp', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Shatkin-Margolis', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Tiffanie', 'Initials': 'T', 'LastName': 'Tam', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Eunsun', 'Initials': 'E', 'LastName': 'Yook', 'Affiliation': 'Hatton Research Institute, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kleeman', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Pauls', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.006']
71,32393214,The transtheoretical model is an effective weight management intervention: a randomized controlled trial.,"BACKGROUND


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


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


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


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


The trial is registered with Brazilian clinical trials under the code: RBR-8t7ssv, Registration date: 12/12/2017 (retrospectively registered).",2020,"The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
","['participants were women, aged 20\u2009years or older who were obese or overweight, users\xa0in PHC service', 'obese low-income women']","['same orientation as the comparison group (CG, n\u2009=\u200935) plus individual health counseling based on the TTM', 'physical exercise and nutrition education']","['anthropometric, food, and nutrient profiles', 'body weight', 'body mass index, resistine, and blood glucose results']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose level - finding'}]",,0.0888361,"The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
","[{'ForeName': 'Patrícia Pinheiro', 'Initials': 'PP', 'LastName': 'de Freitas', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Mariana Carvalho', 'Initials': 'MC', 'LastName': 'de Menezes', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Luana Caroline', 'Initials': 'LC', 'LastName': 'Dos Santos', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adriano Marçal', 'Initials': 'AM', 'LastName': 'Pimenta', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adaliene Versiani Matos', 'Initials': 'AVM', 'LastName': 'Ferreira', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. alinelopesenf@gmail.com.'}]",BMC public health,['10.1186/s12889-020-08796-1']
72,32396285,Strategies to change body composition in older adults: do type of exercise and dose distribution matter?,"BACKGROUND


This study aims to analyze changes in sedentary elderlies' body composition, comparing the impact of two dose distributions: continuous (60 min/session) vs. accumulated (30 min/session in the morning and 30 min/session in the afternoon), on two types of physical exercise programs (multicomponent-training [MCT] vs. walking interval-training [WIT]).
METHODS


Forty-six sedentary overweight elderly (71.3±4.3 years) were evaluated by bioimpedance with a pre-post 2x2 factorial design. Participants were distributed in four homogeneous groups, considering gait and health parameters.
RESULTS


The overall sample showed significant improvements in fat mass (% and kg) and fat-free mass (kg) following 15 weeks of training. There was a main effect of ""type of exercise"" and a moderating effect of ""dose distribution"" reflected in the interaction of both factors. Bonferroni analyses of the type*dose interaction revealed significant improvements in all groups, except for MCT-accumulated, on both body composition compartments.
CONCLUSIONS


Starting exercise training, properly periodized and supervised by physical-education trainers, improves body composition of sedentary elderlies regardless of the type of exercise. Accumulated strategies were beneficial only when applied to WIT. Although MCT training improves body composition with only 2 days/week, WIT-accumulated could be a key element in the design of weight control policies looking for breaking sedentary behaviors.",2020,The overall sample showed significant improvements in fat mass (% and kg) and fat-free mass (kg) following 15 weeks of training.,"['Forty-six sedentary overweight elderly (71.3±4.3 years', 'older adults']","['Starting exercise training, properly periodized and supervised by physical-education trainers', 'MCT training', 'physical exercise programs (multicomponent-training [MCT] vs. walking interval-training [WIT']","['body composition', 'fat mass']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0043197', 'cui_str': 'Wit as Topic'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",46.0,0.0639447,The overall sample showed significant improvements in fat mass (% and kg) and fat-free mass (kg) following 15 weeks of training.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain - pablo.monteagudo@uv.es.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pesce', 'Affiliation': 'Department of Movement, Human and Health Sciences, Foro Italico University, Rome, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10321-9']
73,32335270,"The effect of acute intragastric vs. intravenous alcohol administration on inflammation markers, blood lipids and gallbladder motility in healthy men.","Ethanol intake increases plasma concentrations of triglycerides and chronic ethanol use impairs lipid metabolism and causes chronic inflammation. The gut plays an important role in metabolic handling of nutrients, including lipids, and a leaky gut associated with alcohol intake, allowing inflammatory signals to the portal vein, has been proposed to constitute a mechanism by which ethanol induces hepatic inflammation. We compared the effects of enteral and parenteral administration of ethanol on a range of circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19) as well as gallbladder volume. On two separate and randomized study days, we subjected healthy men (n = 12) to double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI). Blood was sampled and ultrasonographic evaluation of gallbladder volume was performed at frequent intervals for 4 h after initiation of ethanol administration on both days. Little or no effects were observed on plasma levels of inflammation markers during IGEI and IVEI, respectively. Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form. Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations increased more after IGEI compared to IVEI. IVEI had no effect on plasma CCK and caused an increased gallbladder volume whereas IGEI elicited a CCK response (P < 0.0001) without affecting gallbladder volume. Circulating FGF19 concentrations decreased equally in response to both ethanol administration forms. In conclusion, by evaluating a range of circulating inflammation markers during IGEI and IVEI we were not able to detect signs of systemic low-grade inflammation originating from the presence of ethanol in the gut. IVEI increased gallbladder volume whereas IGEI increased plasma CCK (with neutral effect on gallbladder volume), increased plasma VLDL cholesterol and triglyceride concentrations; indicating that the enteral route of administration may influence ethanol's effects on lipid metabolism.",2020,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","['healthy men', 'subjected healthy men (n=12) to']","['double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI', 'Ethanol intake', 'acute intragastric vs. intravenous alcohol', 'ethanol']","['Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations', 'plasma VLDL cholesterol and triglyceride concentrations', 'inflammation markers, blood lipids and gallbladder motility', 'Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol', 'lipid metabolism', 'plasma levels of inflammation markers', 'IVEI increased gallbladder volume whereas IGEI increased plasma CCK', 'gallbladder volume', 'Circulating FGF19 concentrations', 'plasma CCK', 'circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C1431711', 'cui_str': 'FGF19 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0022801', 'cui_str': 'Kupffer cell'}]",,0.130521,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","[{'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gillum', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Holger J', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark. Electronic address: filipknop@dadlnet.dk.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2020.04.006']
74,32335287,Isradipine enhancement of virtual reality cue exposure for smoking cessation: Rationale and study protocol for a double-blind randomized controlled trial.,"Cigarette smoking remains a leading cause of preventable death in the United States, contributing to over 480,000 deaths each year. Although significant strides have been made in the development of effective smoking cessation treatments, most established interventions are associated with high relapse rates. One avenue for increasing the effectiveness of smoking cessation interventions is to design focused, efficient, and rigorous experiments testing engagement of well-defined mechanistic targets. Toward this aim, the current protocol will apply a pharmacologic augmentation strategy informed by basic research in animal models of addiction. Our goal is to evaluate the enhancing effect of isradipine, an FDA-approved calcium channel blocker, on the extinction of craving-a key mechanism of drug relapse after periods of abstinence. To activate craving robustly in human participants, we will use multimodal smoking cues including novel 360° video environments developed for this project and delivered through consumer virtual reality headsets. Adult smokers will take either isradipine or placebo and complete the cue exposure protocol in a double-blind randomized control trial. In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo. The study will be implemented in a primary care setting where adult smokers receive healthcare, and smoking behavior will be tracked throughout the trial with ecological momentary assessment.",2020,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","['human participants', 'Adult smokers', 'smoking cessation']","['isradipine', 'Isradipine', 'isradipine or placebo']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.135599,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Young', 'Affiliation': 'School of Nursing, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Gebhardt', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Perrone', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Morikawa', 'Affiliation': 'Department of Neuroscience, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106013']
75,30250134,Exercise training and/or diet on reduction of intra-abdominal adipose tissue and risk factors for cardiovascular disease.,"BACKGROUND/OBJECTIVES


To test the effects of weight loss with and without exercise training (aerobic or resistance) on intra-abdominal adipose tissue (IAAT) and risk factors for cardiovascular disease (CVD). Additionally, CVD risk factors was evaluated before and after weight loss using previously established IAAT cut-points.
SUBJECTS/METHODS


One hundred twenty-two overweight premenopausal women were randomly assigned to one of three groups: (1) diet only (Diet); (2) diet and aerobic training (Diet + AT); or (3) diet and resistance training (Diet + RT); until a BMI of < 25 kg/m 2  was reached. Computerized tomography was used to measure IAAT and blood lipids were measured by assay. Evaluations were made before and after weight loss.
RESULTS


Though no group-by-time effects were found after weight loss, we observed significant time effects for: IAAT (-38.0%, P < 0.001), total cholesterol (TC) (-2.2%, P = 0.008), low-density lipoprotein cholesterol (LDL-C) (-4.8%, P < 0.001), high-density lipoprotein cholesterol (HDL-C) (+20.2%, P < 0.001), triglycerides (-18.7%, P < 0.001), TC/HDL-C (-16.3%, P < 0.001), and LDL-C/HDL-C (-18.0%, P < 0.001). Following weight loss, 40.2% of all participants reduced IAAT to < 40 cm 2  (IAAT associated with low CVD risk). Furthermore, only 2.5% of participants had an IAAT > 110 cm 2  (IAAT associated with high CVD risk) after weight loss. We also observed that decreases of IAAT were associated with decreased CVD risk factors after weight loss independent of race, changes in %fat mass and changes in maximal oxygen uptake.
CONCLUSIONS


Caloric restriction leading to significant weight loss with or without exercise training appears to be equally effective for reducing IAAT and CVD risk factors.",2019,"Following weight loss, 40.2% of all participants reduced IAAT to < 40 cm 2  (IAAT associated with low CVD risk).",['One hundred twenty-two overweight premenopausal women'],"['diet only (Diet); (2) diet and aerobic training (Diet\u2009+\u2009AT); or (3) diet and resistance training (Diet\u2009+\u2009RT', 'exercise training', 'weight loss with and without exercise training (aerobic or resistance', 'Exercise training and/or diet']","['reduction of intra-abdominal adipose tissue and risk factors for cardiovascular disease', 'triglycerides', 'IAAT and blood lipids', 'high-density lipoprotein cholesterol (HDL-C', 'TC/HDL-C', 'total cholesterol (TC', 'CVD risk factors', 'low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1563739', 'cui_str': 'Intra-Abdominal Fat'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",122.0,0.0219614,"Following weight loss, 40.2% of all participants reduced IAAT to < 40 cm 2  (IAAT associated with low CVD risk).","[{'ForeName': 'Juliano H', 'Initials': 'JH', 'LastName': 'Borges', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA. borges02@hotmail.com.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Carter', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Bryan', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Hunter', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0318-4']
76,32338441,Lung protective ventilation in infants undergoing cardiopulmonary bypass surgery for congenital heart disease: A prospective randomized controlled trial.,"BACKGROUND


Lung protective ventilation (LPV) has been applied to surgical adults with normal pulmonary function for optimizing mechanical ventilation and reducing postoperative pulmonary complications. Few studies have reported the use of LPV in infants undergoing cardiac surgery with cardiopulmonary bypass (CPB).
AIMS


To explore safety and effectiveness of LPV in infants undergoing CPB surgery for congenital heart disease (CHD).
METHODS


Included in this study were 77 infants who underwent CPB surgery for CHD from November 2017 to September 2018. They were randomized into the LPV group and conventional ventilation (CV) group. In the LPV group, small-tidal-volume (6-8 ml/kg) ventilation, lung recruitment by PEEP increment to the maximum level of 15 cm H 2  O after CPB, and individualized optimal PEEP titration were applied. In the CV group, traditional tidal volume (10-12 ml/kg with zero PEEP) was applied. The primary outcome was the ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction (PaO 2  /FiO 2  ). The secondary outcomes were respiratory dynamic parameters, hypoxemia, prognostic indexes, and postoperative pulmonary complications.
RESULTS


PaO 2  /FiO 2  in the LPV group (416.86, 95%CI: 381.60-452.12) was significantly higher than that in the CV group (263.37, 95%CI: 227.65-299.09) after intervention (P < .001). There was a significant difference in the trend of change in dynamic compliance, alveolar-arterial oxygen difference, arterial-end-expired carbon dioxide difference, driving pressure, and respiratory index between the two groups at different time points from weaning from CPB to 2 hours after operation. There was no significant difference in PaO 2  /FiO 2  , alveolar-arterial oxygen difference, respiratory index, and dynamic compliance 2 hours postoperative and in the incidence of postoperative pulmonary complications, prognostic indexes between the two groups.
CONCLUSIONS


LPV could be used safely in infants undergoing CPB in that it can improve oxygenation, alveolar aeration, and dynamic compliance, and reduce driving pressure, pulmonary shunting, and dead space. Its effect on oxygenation, pulmonary gas exchange, and pulmonary compliance was relatively short, and had less impact on postoperative pulmonary complications and prognosis.",2020,"Its effect on oxygenation, pulmonary gas exchange and pulmonary compliance was relatively short, and had less impact on postoperative pulmonary complications and prognosis.","['infants undergoing CPB surgery for congenital heart disease (CHD', 'PaO 2  /FiO', 'infants undergoing cardiac surgery with cardiopulmonary bypass (CPB', '77 infants who underwent CPB surgery for CHD from November 2017 to September 2018', 'infants undergoing cardiopulmonary bypass surgery for congenital heart disease', 'surgical adults with normal pulmonary function']","['LPV group and conventional ventilation (CV', 'Lung protective ventilation', 'Lung protective ventilation (LPV', 'CV', 'LPV']","['dynamic compliance, alveolar-arterial oxygen difference ,  arterial-end expired carbon dioxide difference ,  driving pressure and Respiratory Index', 'respiratory dynamics parameters, hypoxemia, prognostic indexes and postoperative pulmonary complications', 'ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction (PaO 2  /FiO 2  ', 'oxygenation, pulmonary gas exchange and pulmonary compliance', 'small-tidal-volume', 'traditional tidal volume', 'PaO 2  /FiO 2,  alveolar-arterial oxygen difference ,  Respiratory Index and dynamic compliance 2 hours postoperative']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0451423', 'cui_str': 'Respiratory index'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0034071', 'cui_str': 'Exchange, Pulmonary Gas'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]",77.0,0.250211,"Its effect on oxygenation, pulmonary gas exchange and pulmonary compliance was relatively short, and had less impact on postoperative pulmonary complications and prognosis.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Sai-E', 'Initials': 'SE', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital affiliated to The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Jiaotong University School of Medicine, Shanghai, China.'}]",Paediatric anaesthesia,['10.1111/pan.13894']
77,30935339,Immediate improvements of supination range of motion and strength following pronator teres muscle friction massage: a clinical trial comparing people with and without supination limited motion.,"OBJECTIVES


To investigate the effects of friction massage techniques on the pronator teres muscle on supination range of motion (ROM) and supinator strength in individuals with and without limited supination ROM.
METHODS


In total, 26 subjects (13 with limited supination ROM and 13 healthy subjects) volunteered to participate in this study. We used a customized wrist cuff. Supination ROM and supinator strength were measured with a 9-axis inertial motion sensor and load cell. The friction massage protocol was executed with the pronator teres muscle in a relaxed position. Then supination ROM and supinator strength were measured again.
RESULTS


There was no significant interaction effect on supination ROM, which was significantly greater in the limited supination and control groups. A post hoc t-test revealed that the limited supination group achieved a significantly increased post-test supination ROM (51.7 ± 7.8°) compared to the pre-test value (43.6 ± 5.2°). In addition, the control group achieved a significant increase in post-test supination ROM (67.7 ± 10.0°) compared to the pre-test value (61.4 ± 7.7°). There was no significant interaction effect on supinator strength. Supinator strength was significantly greater in the limited supination and control groups. A post hoc t-test revealed a significant difference in supinator strength between the pre- and post-test values in the limited supination group.
DISCUSSION


Friction massage helps restore a limited ROM of the forearm supination motion and immediately increases supinator muscle strength. This technique can be used as an intervention method to improve muscle strength in patients with limited supination ROM.",2019,"There was no significant interaction effect on supination ROM, which was significantly greater in the limited supination and control groups.","['people with and without supination limited motion', 'patients with limited supination ROM', '26 subjects (13 with limited supination ROM and 13 healthy subjects) volunteered to participate in this study', 'individuals with and without limited supination ROM']","['friction massage techniques', 'pronator teres muscle friction massage', 'Friction massage']","['supination ROM', 'supination range of motion (ROM) and supinator strength', 'supination range of motion and strength', 'supinator strength', 'muscle strength', 'Supination ROM and supinator strength', 'supination ROM and supinator strength', 'post-test supination ROM', 'Supinator strength']","[{'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]","[{'cui': 'C0556839', 'cui_str': 'Physiotherapeutic frictions'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0224249', 'cui_str': 'Pronator teres muscle structure'}]","[{'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",26.0,0.0192322,"There was no significant interaction effect on supination ROM, which was significantly greater in the limited supination and control groups.","[{'ForeName': 'Jun-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'a Department of Physical Therapy, Graduate School , Yonsei University , Wonju , Korea.'}, {'ForeName': 'Ui-Jae', 'Initials': 'UJ', 'LastName': 'Hwang', 'Affiliation': 'a Department of Physical Therapy, Graduate School , Yonsei University , Wonju , Korea.'}, {'ForeName': 'Sung-Hoon', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'a Department of Physical Therapy, Graduate School , Yonsei University , Wonju , Korea.'}, {'ForeName': 'Gyeong-Tae', 'Initials': 'GT', 'LastName': 'Gwak', 'Affiliation': 'a Department of Physical Therapy, Graduate School , Yonsei University , Wonju , Korea.'}, {'ForeName': 'Oh-Yun', 'Initials': 'OY', 'LastName': 'Kwon', 'Affiliation': 'b Department of Rehabilitation Medicine, Wonju Christian Hospital, Wonju College of Medicine , Yonsei University , Wonju , Korea.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2018.1542559']
78,30946005,Do prognostic variables predict a set of outcomes for patients with chronic low back pain: a long-term follow-up secondary analysis of a randomized control trial.,"Objective : The objective was to explore for universal prognostic variables, or predictors, across three different outcome measures in patients with chronic low back pain (LBP). We hypothesized that selected prognostic variables would be 'universal' prognostic variables, regardless of the outcome measures used.  Methods : This study was a secondary analysis of data from a previous randomized controlled trial comparing the McKenzie treatment approach with placebo in patients with chronic LBP. Ten baseline prognostic variables were explored in predictive models for three outcomes: pain intensity, disability, and global perceived effect, at 6 and 12 months. Predictive models were created using backward stepwise logistic and linear multivariate regression analyses.  Results : Several predictors were present including age, expectancy of improvement, global perceived effect; however, we only identified baseline disability as a universal predictor of outcomes at 6 months. The second most represented universal predictor was baseline pain intensity for outcomes at 12 months.  Discussion : Only two predictors demonstrated an association with more than one outcome measure. High baseline disability predicts multidimensional outcome measures at 6 months in patients with chronic LBP while baseline pain intensity can best predict the outcome at 12 months. Nevertheless, other predictors seem to be unique to the outcome used. Level of evidence: 2c.",2019,High baseline disability predicts multidimensional outcome measures at 6 months in patients with chronic LBP while baseline pain intensity can best predict the outcome at 12 months.,"['patients with chronic low back pain (LBP', 'patients with chronic low back pain', 'patients with chronic LBP']","['McKenzie', 'placebo']","['baseline pain intensity', 'pain intensity, disability, and global perceived effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.220096,High baseline disability predicts multidimensional outcome measures at 6 months in patients with chronic LBP while baseline pain intensity can best predict the outcome at 12 months.,"[{'ForeName': 'Alessandra Narciso', 'Initials': 'AN', 'LastName': 'Garcia', 'Affiliation': 'a Doctor of Physical Therapy Division, Department of Orthopaedic Surgery, Duke University , Durham , NC , USA.'}, {'ForeName': 'Leonardo O P', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'b Physical Therapy, University Cidade de Sao Paulo , Sao Paulo , Brazil.'}, {'ForeName': 'Luciola Da Cunha Menezes', 'Initials': 'LDCM', 'LastName': 'Costa', 'Affiliation': 'd Physical Therapy, Universidade Cidade de São Paulo , Sao Paulo , Brazil.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hancock', 'Affiliation': 'e Discipline of Physiotherapy, Faculty of Human Sciences, Macquarie University , Sydney , Australia.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'f Doctor of Physical Therapy Division, Duke Clinical Research Institute, Duke University , Durham , NC , USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1597435']
79,32333707,Effects of active commuting to work for 12 months on cardiovascular risk factors and body composition.,"Active commuting has the potential to decrease cardiovascular risk by increasing physical activity. We aimed to investigate the effects of active commuting to work for 12 months on body composition and cardiovascular risk factors. Therefore, 73 hospital employees (age: 46 ± 9 years, 36% males), with a predominantly passive way of commuting, were randomly assigned to an intervention group (IG) and a control group (CG) in a 2:1 fashion. The IG was further divided into a public transportation plus active commuting group (IG-PT) and a cycling group (IG-C). Both IGs were prompted to reach 150 min/wk of moderate intensity exercise. Daily self-reported commuting details were verified by GPS tracking. All subjects underwent assessment of body composition, resting blood pressure, glycemic control, and lipid profile at the beginning and end of the study. Data for final analyses were available in 62 subjects. Commuting details indicated that the subjects randomized to IG changed their commuting habits. HbA1c decreased by 0.2% [95%CI: -0.3, -0.2] in IG-PT but was not statistically different between groups (P = .06). LDL cholesterol decreased in IG-C by 0.8 mmol/L [-1.1, -0.4] and by 0.6 mmol/L [-1.2, 0.1] in IG-PT which can be considered biologically relevant but did not yield statistical significance. Body composition and blood pressure did not differ between groups. Active commuting to work for 12 months did not change body composition but yielded relevant changes in lipid profile and glycemic control. Health benefits of active commuting should be addressed by healthcare professionals when counseling individuals that seek to improve their cardiovascular risk profile.",2020,"HbA1c decreased by 0.2% [95%CI: -0.3, -0.2] in IG-PT but was not statistically different between groups (p=0.06).","['73 hospital employees (age: 46±9 years, 36% males), with a predominantly passive way of commuting', '62 subjects']",['intervention group (IG) and a control group (CG'],"['Body composition and blood pressure', 'cardiovascular risk factors and body composition', 'LDL-cholesterol', 'HbA1c', 'lipid profile and glycaemic control', 'body composition, resting blood pressure, glycaemic control and lipid profile', 'body composition and cardiovascular risk factors']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",73.0,0.0275109,"HbA1c decreased by 0.2% [95%CI: -0.3, -0.2] in IG-PT but was not statistically different between groups (p=0.06).","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sareban', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Fernandez La Puente de Battre', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reich', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmied', 'Affiliation': 'Department of Cardiology, University Heart Centre, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Loidl', 'Affiliation': 'Department of Geoinformatics, Paris Lodron University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Department of Cardiology, University Heart Centre, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13695']
80,32316995,The Nordic maintenance care program: maintenance care reduces the number of days with pain in acute episodes and increases the length of pain free periods for dysfunctional patients with recurrent and persistent low back pain - a secondary analysis of a pragmatic randomized controlled trial.,"BACKGROUND


A recent study showed that chiropractic patients had fewer days with bothersome (activity-limiting) low back pain (LBP) when receiving care at regular pre-planned intervals regardless of symptoms ('maintenance care', MC) compared to receiving treatment only with a new episode of LBP. Benefit varied across psychological subgroups. The aims of this study were to investigate 1) pain trajectories around treatments, 2) recurrence of new episodes of LBP, and 3) length of consecutive pain-free periods and total number of pain-free weeks, for all study participants as well as for each psychological subgroup.
METHODS


A secondary analysis of data from a randomized controlled trial of patients (n = 319) seeking chiropractic care for recurrent or persistent LBP used 52 weekly estimates of days with bothersome (activity-limiting) LBP. First, a generalized estimating equations analysis was used to compare the pain trajectory before and after the initial treatment in every new treatment period. Thereafter, a time-to-event analysis (using Cox regression) estimated time to/risk of a new LBP episode. The analyses were performed on i) all study participants and ii) separately for each psychological sub-group (named adaptive copers, interpersonally distressed and dysfunctional) classified by the West Haven-Yale Multidimensional Pain Inventory.
RESULTS


Patients receiving MC had flat pain trajectories around each new treatment period and reported fewer days with pain compared to patients receiving the control intervention. The entire effect was attributed to the dysfunctional subgroup who reported fewer days with activity limiting pain within each new LBP episode as well as longer total pain-free periods between episodes with a difference of 9.8 weeks (CI 95% 3.3, 16.3) compared to the control group. There were no differences in the time to/risk of a new episode of LBP in either of the subgroups.
CONCLUSION


Data support the use of MC in a stratified care model targeting dysfunctional patients for MC. For a carefully selected group of patients with recurrent and persistent LBP the clinical course becomes more stable and the number of pain-free weeks between episodes increases when receiving MC. Understanding how subgroups of patients are likely to be affected by MC may help align patients' and clinicians' expectations based on realistic outcomes.
TRIAL REGISTRATION


Clinical trials.gov; NCT01539863; February 22, 2012.",2020,"RESULTS


Patients receiving MC had flat pain trajectories around each new treatment period and reported fewer days with pain compared to patients receiving the control intervention.","['patients (n\xa0=\u2009319) seeking chiropractic care for recurrent or persistent LBP used 52 weekly estimates of days with bothersome (activity-limiting) LBP', 'chiropractic patients had fewer days with bothersome (activity-limiting) low back pain (LBP', 'dysfunctional patients with recurrent and persistent low back pain ']","['psychological sub-group (named adaptive copers, interpersonally distressed and dysfunctional) classified by the West Haven-Yale Multidimensional Pain Inventory']","['activity limiting pain', 'total pain-free periods', 'pain trajectory', 'pain trajectories around treatments, 2) recurrence of new episodes of LBP, and 3) length of consecutive pain-free periods and total number of pain-free weeks', 'pain', 'time to/risk of a new episode of LBP', 'flat pain trajectories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205324', 'cui_str': 'Flat'}]",,0.14098,"RESULTS


Patients receiving MC had flat pain trajectories around each new treatment period and reported fewer days with pain compared to patients receiving the control intervention.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eklund', 'Affiliation': 'Karolinska Institutet, Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Stockholm, Sweden. andreas.eklund@ki.se.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hagberg', 'Affiliation': 'Karolinska Institutet, Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Stockholm, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Karolinska Institutet, Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Stockholm, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'Institute for Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kongsted', 'Affiliation': 'Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lövgren', 'Affiliation': 'Private practice, Stockholm, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Jonsson', 'Affiliation': 'Private practice, Lidköping, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Petersen-Klingberg', 'Affiliation': 'Private practice, Borlänge, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Calvert', 'Affiliation': 'Private practice, Falkenberg, Sweden.'}, {'ForeName': 'Iben', 'Initials': 'I', 'LastName': 'Axén', 'Affiliation': 'Karolinska Institutet, Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Stockholm, Sweden.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00309-6']
81,32084530,Effects of antiemetic doses of dexamethasone on plasma mediators of inflammation resolution and pain after surgery in women.,"BACKGROUND


Dexamethasone is commonly given as an antiemetic during surgical procedures. It has immunosuppressive effects and can affect key enzymes involved in the synthesis of specialised lipid mediators of inflammation resolution (SPM) that direct inflammation resolution and have anti-nociceptive actions. This study examined the effect of dexamethasone on plasma SPM, and the relationship between SPM and perceived pain in women undergoing surgery.
METHODS


Plasma SPM were measured in samples obtained from two double-blind controlled interventions. The first, included 51 women mean age 53 ± 1.5 years, undergoing breast surgery allocated to either intravenous saline, or dexamethasone (4 mg or 8 mg) after induction of anaesthesia. The second study included 31 women of mean age 44 ± 0.5 years undergoing laparoscopic gynecological surgery that were allocated to either saline, or dexamethasone (4 mg). SPM (18-HEPE, 17-HDHA, RvE2, RvD1 17R-RvD1 and RvD2) were measured in plasma collected prior to induction of anaesthesia and at 24 h, and 6 weeks post-surgery. Pain was assessed using a verbal analogue scale at discharge from the post-anaesthesia recovery unit. The data from each study was combined to examine the effect of dexamethasone on plasma SPM. The relationship between pain score and SPM was examined using ordinal logistic regression.
RESULTS


The SPM 18-HEPE, 17-HDHA, RvE2, RvD1 17R-RvD1 and RvD2 were detectable in all plasma samples. There was no significant difference in any SPM due to dexamethasone over the duration of the study. There was a fall in 17-HDHA between baseline and 24 h in both the dexamethasone and saline groups (P = 0.003) but no change in the downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2. Pain score was negatively related to levels of RvE2 measured prior to induction of anaesthesia (rho = -0.2991, P = 0.006) and positively related to BMI (rho = 0.279, P = 0.011). In ordinal logistic regression the odds ratio for RvE2 was 0.931 (CI 0.880, 0.986; P = 0.014); after adjusting for the effect of BMI indicating that an increase in RvE2 of 1 pg/ml would result in a 6.9 % fall in pain score. Allocation to a dexamethasone group did not influence the pain score or the relationship between RvE2 and pain score.
CONCLUSION


Dexamethasone administered as an anti-emetic does not affect plasma SPM levels. An elevated RvE2 level prior to surgery is predictive of a lower perceived pain score post-anaesthesia.",2020,"There was a fall in 17-HDHA between baseline and 24 h in both the dexamethasone and saline groups (P = 0.003) but no change in the downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2.","['31 women of mean age 44 ± 0.5 years undergoing laparoscopic gynecological surgery', '51 women mean age 53 ± 1.5 years, undergoing breast surgery allocated to either', 'women undergoing surgery', 'after surgery in women']","['Dexamethasone', 'saline, or dexamethasone', 'intravenous saline, or dexamethasone', 'SPM ', 'dexamethasone']","['levels of RvE2 measured prior to induction of anaesthesia', 'Pain score', 'RvE2', '18-HEPE, 17-HDHA', 'SPM', 'plasma mediators of inflammation resolution and pain', 'pain score', 'downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2', 'plasma SPM levels', 'fall in 17-HDHA', 'Pain', 'elevated RvE2 level', 'pain score and SPM', 'RvE2 and pain score', 'plasma SPM', 'RvD1 17R-RvD1 and RvD2', 'RvE2, RvD1 17R-RvD1 and RvD2']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C4310301', 'cui_str': '17(S)-HDHA'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0243042', 'cui_str': 'Inflammation Mediators'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",51.0,0.225454,"There was a fall in 17-HDHA between baseline and 24 h in both the dexamethasone and saline groups (P = 0.003) but no change in the downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Barden', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia. Electronic address: anne.barden@uwa.edu.au.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Harry Perkins Institute for Medical Research, University of Western Australia, Australia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Mas', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Hill', 'Affiliation': 'Department of Anaesthesia, St John of God Midland and Mount Lawley Hospitals, Perth, Western Australia, Western Australia, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Mowat', 'Affiliation': 'Department of Anaesthesia, Royal Bournemouth & Christchurch Hospitals NHS Foundation Trusts, United Kingdom.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Loh', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Corcoran', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia; Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Mori', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia.'}]",Prostaglandins & other lipid mediators,['10.1016/j.prostaglandins.2020.106427']
82,32394874,Combination Therapy Against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (Fungisome TM ) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy.,"Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe, and is a major public health problem in the Indian subcontinent. Miltefosine received approval in 2002 to treat VL in India, and the Indian National Vector Borne Disease Control Programme later adopted a single dose (10 mg/kg) of liposomal amphotericin B. We report results of a randomized trial comparing the efficacy of combination therapy with an Indian preparation of liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine (2.5 mg/kg/day for 14 days;  n  = 66) in comparison to miltefosine monotherapy (2.5 mg/kg/day for 28 days;  n  = 78). Nine patients in the miltefosine group and three in the combination therapy group had to discontinue therapy because of serious adverse events. At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups. By per-protocol analysis, by 6 months after completion of treatment, 12 of 69 patients in the miltefosine monotherapy arm (17.4%, 95% CI: 10.24-28%) and none in the combination therapy arm had relapse. Over 5 years of follow-up, 10 patients in the miltefosine monotherapy arm (all within 0.5-2 years after completing therapy) and none in the combination therapy arm experienced post-kala-azar dermal leishmaniasis. Combination therapy offered benefits over miltefosine monotherapy for VL in India.",2020,"At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups.","['Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe']","['Miltefosine', 'miltefosine', 'liposomal amphotericin', 'miltefosine monotherapy', 'liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine', 'Liposomal Amphotericin B (Fungisome TM ) and Short-Course Miltefosine']","['relapse', 'discontinue therapy because of serious adverse events', 'clinical and parasitological cure rate']","[{'cui': 'C0023290', 'cui_str': 'Visceral leishmaniasis'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0037724', 'cui_str': 'Southern Europe'}]","[{'cui': 'C0068006', 'cui_str': 'miltefosine'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}]",,0.0417871,"At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups.","[{'ForeName': 'Rama Prosad', 'Initials': 'RP', 'LastName': 'Goswami', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Mehebubar', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Sukhen', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Santanu Kumar', 'Initials': 'SK', 'LastName': 'Tripathi', 'Affiliation': 'Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Rudra Prosad', 'Initials': 'RP', 'LastName': 'Goswami', 'Affiliation': 'Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0931']
83,32334955,Assessing an App-Based Child Restraint System Use Intervention in China: An RCT.,"INTRODUCTION


While child restraint systems are effective in protecting children from crash-related injuries and deaths, their use in China is extremely low. This study assessed the effectiveness of child restraint system education with and without behavioral skills training on improved use and explored participants' views regarding content and delivery of an onsite intervention and online (WeChat) boosters.
STUDY DESIGN


A randomized trial was conducted in 6 kindergartens from May 2017 to January 2018 in Shantou and Chaozhou, China. Selected kindergartens were randomly assigned to 3 groups: (1) control, (2) child restraint system education‒only, and (3) child restraint system education plus behavioral skills training. Analysis was conducted in May 2018.
SETTING/PARTICIPANTS


Participants were parents from the selected kindergartens.
INTERVENTION


Both intervention groups received child restraint system education that included one-time onsite education and biweekly online boosters for 3 months using an app to deliver education messages.
MAIN OUTCOME MEASURES


Survey questions included parent knowledge, attitude and behaviors of child restraint system use, and opinions related to the content and delivery of the onsite intervention and online boosters.
RESULTS


Child restraint system use in both intervention groups was higher than that of the control group post-intervention (27.3% and 31.7%, respectively). Compared with the control group, the intervention groups had a higher percentage of correct answers to all 9 items, except Item 7 measuring the parents' knowledge, attitude, and behaviors of child passenger safety after the intervention. Lower parent's level of education (OR=7.00, 95% CI=2.62, 18.70) and older child age (4 years: OR=3.92, 95% CI=1.08, 5.28; 5 years: OR=2.08, 95% CI=1.52, 5.31) were associated with lower rates of child restraint system use. Most parents (92.3%) preferred the online over the onsite intervention component.
CONCLUSIONS


An education intervention was effective in improving parents' knowledge, attitude, and practice of child restraint system use. A social media intervention booster (WeChat) may provide a new channel to help promote child passenger safety in China.",2020,"Compared with the control group, the intervention groups had a higher percentage of correct answers to all 9 items, except Item 7 measuring the parents' knowledge, attitude, and behaviors of child passenger safety after the intervention.","['China', '6 kindergartens from May 2017 to January 2018 in Shantou and Chaozhou, China', 'older child age (4 years', 'Participants were parents from the selected kindergartens']","['onsite intervention and online (WeChat) boosters', 'control, (2) child restraint system education‒only, and (3) child restraint system education plus behavioral skills training', 'child restraint system education with and without behavioral skills training', 'App-Based Child Restraint System Use Intervention', 'child restraint system education that included one-time onsite education and biweekly online boosters for 3 months using an app to deliver education messages', 'education intervention']","['parent knowledge, attitude and behaviors of child restraint system use, and opinions related to the content and delivery of the onsite intervention and online boosters', ""parents' knowledge, attitude, and practice of child restraint system use"", ""parents' knowledge, attitude, and behaviors of child passenger safety""]","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1319152', 'cui_str': 'Knowledge level: parenting'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0450048', 'cui_str': 'Passenger'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0339503,"Compared with the control group, the intervention groups had a higher percentage of correct answers to all 9 items, except Item 7 measuring the parents' knowledge, attitude, and behaviors of child passenger safety after the intervention.","[{'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Jingzhen', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Center for Injury Research and Policy, Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Jingmei', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Kele', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Health Sciences, Kent State University, Kent, Ohio.'}, {'ForeName': 'Wanbao', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China. Electronic address: lpli@stu.edu.cn.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.003']
84,31369152,Nitrous oxide anesthetic versus total intravenous anesthesia for functional endoscopic sinus surgery.,"BACKGROUND


Functional endoscopic sinus surgery is a common procedure for sinonasal disease, frequently performed in the outpatient setting. General anesthesia maintained with total intravenous anesthesia (TIVA) with propofol has been shown to give superior surgical conditions compared to inhaled anesthetics. This study evaluated the effects of TIVA versus a predominantly nitrous oxide (N 2  O)-based anesthetic with a low-dose propofol and remifentanil infusion on sinus surgery.
METHODS


Patients were randomized to either a N 2  O-based (nitrous oxide with propofol and remifentanil) or TIVA (propofol and remifentanil without nitrous oxide) group. The surgeon was blinded to the anesthetic technique. Surgical field grading was performed in real time by the otolaryngologist every 15 minutes with the Boezaart grading system.
RESULTS


There were no statistically significant differences between the Boezaart scores, duration of surgery, or estimated blood loss between the two anesthetic techniques. However, the use of N 2  O provided a statistically significant, 38% reduction in time from surgery end to extubation. The TIVA group had significantly decreased mean and median pain scores in the post-anesthesia care unit (PACU). There was no difference in the rate of postoperative nausea and vomiting between the two groups.
CONCLUSION


A N 2  O-based anesthetic for functional endoscopic sinus surgery provides similar intraoperative and postoperative conditions when compared to TIVA, while being superior in terms of time to extubation. Although the TIVA group had significantly decreased pain scores, this did not lead to a decrease in pain medicine received in the PACU, and there was no difference between groups in time to discharge.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:E299-E304, 2020.",2020,"There were no statistically significant differences between the Boezaart scores, duration of surgery, or estimated blood loss between the two anesthetic techniques.","['Patients', 'functional endoscopic sinus surgery']","['General anesthesia maintained with total intravenous anesthesia (TIVA) with propofol', 'Functional endoscopic sinus surgery', 'Nitrous oxide anesthetic versus total intravenous anesthesia', 'N 2  O-based (nitrous oxide with propofol and remifentanil) or TIVA (propofol and remifentanil without nitrous oxide', 'TIVA', 'nitrous oxide (N 2  O)-based anesthetic with a low-dose propofol and remifentanil infusion']","['rate of postoperative nausea and vomiting', 'time to discharge', 'mean and median pain scores', 'pain medicine', 'Boezaart scores, duration of surgery, or estimated blood loss', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}]",,0.0364695,"There were no statistically significant differences between the Boezaart scores, duration of surgery, or estimated blood loss between the two anesthetic techniques.","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Heller', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'DeMaria', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Hyman', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Alfred M C', 'Initials': 'AMC', 'LastName': 'Iloreta', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Hung-Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Govindaraj', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Adam I', 'Initials': 'AI', 'LastName': 'Levine', 'Affiliation': 'The Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28201']
85,31829664,Live counselor contact in a Facebook intervention predicts smoking cessation outcomes.,"Digital smoking cessation interventions frequently use automated delivery of content. Integrating a counselor may improve participant engagement and facilitate health behavior change. We investigated engagement with live counseling compared to automated content in a Facebook intervention and the impact of engagement on smoking cessation outcomes. The Tobacco Status Project is a 90-day smoking cessation intervention for young adults utilizing automated posts and weekly sessions with a live counselor in Facebook groups tailored to readiness to quit (precontemplation, contemplation, preparation). Data came from the treatment group of a randomized trial. Post-level analyses investigated participant engagement (number of comments) by post type (e.g., counselor posts or automated posts based on transtheoretical model of behavior change, clinical practice guidelines, motivational interviewing), stratified by readiness to quit. Participant-level analyses examined whether extent of participant engagement with counselor posts predicted abstinence at 3 months. We analyzed data of  N  = 251 participants and  N  = 2,941 posts, 11% of which were live counselor initiated, and together generated 8,403 comments. Post-level analyses found that compared to the most engaging automated content (motivational content for precontemplation and contemplation, informational content for preparation), live counseling generated more engagement among participants in preparation, similar engagement in precontemplation, and less engagement in contemplation. Extent of live counseling participation predicted 3-month verified abstinence (adjusted  OR  = 1.10, 95% CI [1.02, 1.20]). In digital interventions, counselor contact may be beneficial in addition to automated posts at yielding engagement and abstinence; however, participants engage differently with counseling according to readiness to quit. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Extent of live counseling participation predicted 3-month verified abstinence (adjusted  OR  = 1.10, 95% CI [1.02, 1.20]).","['N  = 251 participants and  N  = 2,941 posts, 11% of which were live counselor initiated, and together generated 8,403 comments']","['Digital smoking cessation interventions', 'Facebook intervention', 'live counseling']",[],"[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",[],,0.0515934,"Extent of live counseling participation predicted 3-month verified abstinence (adjusted  OR  = 1.10, 95% CI [1.02, 1.20]).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Tice', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Oona', 'Initials': 'O', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000541']
86,32325038,"Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.","BACKGROUND


Cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection continue to rise in the Arabian Peninsula 7 years after it was first described in Saudi Arabia. MERS-CoV poses a significant risk to public health security because of an absence of currently available effective countermeasures. We aimed to assess the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans.
METHODS


This dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial was done at the Centre for Clinical Vaccinology and Tropical Medicine (Oxford, UK) and included healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women). Participants received a single intramuscular injection of ChAdOx1 MERS at three different doses: the low-dose group received 5 × 10 9  viral particles, the intermediate-dose group received 2·5 × 10 10  viral particles, and the high-dose group received 5 × 10 10  viral particles. The primary objective was to assess safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited, unsolicited, and serious adverse events after vaccination. The secondary objective was to assess the cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays after vaccination. Participants were followed up for up to 12 months. This study is registered with ClinicalTrials.gov, NCT03399578.
FINDINGS


Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at 6 months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 10 10  viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed to be not related to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered to be possibly, probably, or definitely related to ChAdOx1 MERS were predominantly mild in nature and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001) Laboratory adverse events considered to be at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
INTERPRETATION


ChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to elicit both humoral and cellular responses against MERS-CoV. The results of this first-in-human clinical trial support clinical development progression into field phase 1b and 2 trials.
FUNDING


UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.",2020,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","['healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women', '24 participants were enrolled: six', 'Between March 14 and Aug 15, 2018', 'humans']","['single intramuscular injection of ChAdOx1 MERS', 'low-dose group received 5\u2008×\u200810 9  viral particles, the intermediate-dose group received 2·5\u2008×\u200810 10  viral particles, and the high-dose group received 5\u2008×\u200810 10  viral particles', 'candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine', 'ChAdOx1 MERS']","['Unsolicited adverse events', 'cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays', 'Safety and immunogenicity', 'safety and tolerability of ChAdOx1 MERS', 'serious adverse events', 'safe and well tolerated', 'safety and immunogenicity', 'Neutralising antibodies against live MERS-CoV', 'T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen', 'occurrence of solicited, unsolicited, and serious adverse events', 'proportion of moderate and severe adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019683', 'cui_str': 'Human immunodeficiency virus antibody'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",24.0,0.0881364,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Ramos', 'Initials': 'FR', 'LastName': 'Lopez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mair', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheridan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Young-Shin', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Jae-Ouk', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Manki', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Datoo', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30160-2']
87,30935338,Time-course changes associated with PA lumbar mobilizations on lumbar and hamstring range of motion: a randomized controlled crossover trial.,"OBJECTIVE


We aimed to compare the post-intervention time-course changes in active knee extension (AKE) and active lumbar flexion (ALF) range of motion in response to unilateral posterior-anterior (UPA) mobilizations of the lumbar spine (L4/5 zygapophyseal).
METHODS


Twenty-four asymptomatic participants (maleness: 0.58, age [mean ± standard deviation]: 32 ± 8 years, body mass index 25.9 ± 2.6 kg m 2 ) were recruited to a fully controlled crossover trial. Following either the intervention (L4/5 zygapophyseal mobilizations) or control, participants immediately performed the AKE and ALF tests, which were also performed at baseline. Subsequent tests were made at intervals of 5, 10, 15, 20, 25, 30, 45 and 60 min.
RESULTS


After adjustment for baseline (mean AKE: 37.2° from full extension, mean ALF: 14.37 cm), sex and age, UPA lumbar mobilizations had a most likely moderate effect on AKE (9.8° closer to full extension; ±1.9) and a likely moderate effect on ALF (1.34 cm; ±90% confidence limits 0.43). The magnitude of the AKE effect became most likely small 20-min posttreatment (5.3; ±1.7) and possibly small/possibly trivial 60-min posttreatment (2.1; ±1.4). For ALF, the magnitude of the effect became most likely small 15-min posttreatment (0.76; ±0.25), possibly small/possibly trivial 25-min posttreatment (0.38; ±0.18) and likely trivial 60-min posttreatment (0.26; ±1.8).
DISCUSSION


UPA lumbar mobilizations increased lumbar Range of Motion and hamstring extensibility by a moderate magnitude, with the effect reducing after 10-20-min posttreatment. Clinicians should consider these time-course changes when applying UPA lumbar mobilizations. Clinical Trials Registry: NCT03273400 Evidence Level: 2b.",2019,"After adjustment for baseline (mean AKE: 37.2° from full extension, mean ALF: 14.37 cm), sex and age, UPA lumbar mobilizations had a most likely moderate effect on AKE (9.8° closer to full extension; ±1.9) and a likely moderate effect on ALF (1.34 cm; ±90% confidence limits 0.43).","['Twenty-four asymptomatic participants (maleness', 'standard deviation]: 32\xa0±\xa08\xa0years, body mass index 25.9\xa0±\xa02.6 kg\xa0m 2 ']","['PA lumbar mobilizations', 'unilateral posterior-anterior (UPA) mobilizations of the lumbar spine (L4/5 zygapophyseal']","['lumbar and hamstring range of motion', 'lumbar Range of Motion and hamstring extensibility']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0556761', 'cui_str': 'Mobilization of the lumbar spine (regime/therapy)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",24.0,0.0997241,"After adjustment for baseline (mean AKE: 37.2° from full extension, mean ALF: 14.37 cm), sex and age, UPA lumbar mobilizations had a most likely moderate effect on AKE (9.8° closer to full extension; ±1.9) and a likely moderate effect on ALF (1.34 cm; ±90% confidence limits 0.43).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chesterton', 'Affiliation': 'a Department of Physiotherapy, Sport Rehabilitation, Dietetics and Leadership , Teesside University , Middlesbrough , UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Evans', 'Affiliation': 'b Faculty of Health Sciences and Wellbeing , Sunderland University , UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Livadas', 'Affiliation': 'a Department of Physiotherapy, Sport Rehabilitation, Dietetics and Leadership , Teesside University , Middlesbrough , UK.'}, {'ForeName': 'Shaun J', 'Initials': 'SJ', 'LastName': 'McLaren', 'Affiliation': 'c Institute for Sport, Physical Activity and Leisure , Leeds Beckett University , Leeds , UK.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2018.1542558']
88,32151851,A calcium channel or angiotensin converting enzyme inhibitor/angiotensin receptor blocker regime to reduced blood pressure variability in acute ischaemic stroke (CAARBS): A feasibility trial.,"BACKGROUND


Trials of lowering blood pressure in patients with acute ischaemic stroke not undergoing thrombolysis have not demonstrated improved outcomes with intervention. Rather than absolute levels, it may be that blood pressure variability is important. However, there are no prospective randomised trials investigating the benefit of reducing blood pressure variability in this patient group.
AIMS


The primary aim of this trial was to determine the feasibility of recruitment to a randomised trial investigating the effect of different antihypertensive medications on blood pressure variability.
METHODS


CAARBS was a multi-centre, open-label, randomised parallel group controlled feasibility trial. Adults with a first mild-moderate ischaemic stroke or transient ischaemic attack, requiring antihypertensive therapy for secondary prevention, were randomised to a calcium channel blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Blood pressure and variability were measured at baseline, three weeks, and three months. Compliance with measurements and treatment was monitored.
RESULTS


Fourteen patients were recruited to the trial (0.6% of those screened), nine of whom completed follow-up. The majority of patients screened (98.1%) were ineligible. Compliance with the intervention was good, as were measurement completion rates (88.9% or higher in all cases except ambulatory measurements). No major adverse events were recorded.
CONCLUSIONS


Recruitment to the trial was difficult due to patient ineligibility, suggesting that the current protocol is unlikely to be successful if scaled for a definitive trial. However, the intervention was safe, and compliance was good, suggesting a future trial with modified eligibility criteria could be successful.
TRIAL REGISTRATION


ISRCTN10853487.",2020,"No major adverse events were recorded.
","['patients with acute ischaemic stroke not undergoing thrombolysis', 'Adults with a first mild-moderate ischaemic stroke or transient ischaemic attack, requiring antihypertensive therapy for secondary prevention', 'acute ischaemic stroke (CAARBS', 'Fourteen patients were recruited to the trial (0.6% of those screened), nine of whom completed follow-up']","['calcium channel blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker', 'calcium channel or angiotensin converting enzyme inhibitor/angiotensin receptor blocker regime', 'antihypertensive medications']","['Blood pressure and variability', 'blood pressure variability', 'major adverse events', 'measurement completion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy (procedure)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",14.0,0.278614,"No major adverse events were recorded.
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK. Electronic address: willdavison@doctors.org.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Appiah', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; NIHR Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Iain J', 'Initials': 'IJ', 'LastName': 'McGurgan', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116753']
89,32333010,Feasibility of manual white blood cell counts as a predictor of neonatal sepsis in a low-resource setting.,"BACKGROUND


Manual white blood cell (WBC) differential counts as a predictor for neonatal sepsis development in a low-resource setting have not been thoroughly evaluated. We hypothesized that manual differentiation (specifically immature:total [I:T] neutrophil ratios) would be feasible and useful as an adjunct to predict early-onset neonatal sepsis (EONS). Secondarily, we hypothesized that vaccination with bacillus Calmette-Guérin (BCG) and oral polio vaccine (OPV) could alter WBC differential counts and thus might reduce its predictive performance.
METHODS


We performed a prospective cohort study within a randomized trial, randomizing healthy, high-risk newborns admitted to the nursery at the national hospital in Guinea-Bissau 1:1 to BCG+OPV at admission or at discharge (usual practice). Thin capillary blood films were prepared at 2 d of age in a subset of 268 neonates. WBC counts were assessed by microscopy and neonates were followed up for sepsis development within 2 weeks.
RESULTS


Ninety-eight percent (264/268) of smears provided interpretable reads. Of the 264 children, 136 had been randomized to receive BCG+OPV prior to sampling; the remaining 128 were vaccinated at discharge. The I:T ratio (average 0.017) was lower among children who did not develop clinical sepsis but did not predict sepsis (p=0.70). Only three children had an I:T ratio >0.2 (associated with a higher probability of clinical sepsis in previous studies) but did not develop sepsis. Immunization did not alter WBC composition.
CONCLUSIONS


Manual WBC differentials are feasible in low-resource settings. WBC differentials are not affected by standard newborn immunization. However, the I:T ratio had no value in predicting subsequent development of sepsis.",2020,The I:T ratio (average 0.017) was lower among children who did not develop clinical sepsis but did not predict sepsis (p=0.70).,"['randomizing healthy, high-risk newborns admitted to the nursery at the national hospital in Guinea-Bissau 1:1 to BCG+OPV at admission or at discharge (usual practice', 'Ninety-eight percent (264/268) of smears', '264 children, 136 had been randomized to receive']","['bacillus Calmette-Guérin (BCG) and oral polio vaccine (OPV', 'BCG+OPV']","['neonatal sepsis', 'WBC counts', 'WBC composition']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018387', 'cui_str': 'Guinea-Bissau'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",264.0,0.15553,The I:T ratio (average 0.017) was lower among children who did not develop clinical sepsis but did not predict sepsis (p=0.70).,"[{'ForeName': 'Christian N', 'Initials': 'CN', 'LastName': 'Golding', 'Affiliation': 'Bandim Health Project, Indepth Network, Apartado 861, Bissau 1004, Guinea-Bissau.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Schaltz-Buchholzer', 'Affiliation': 'Bandim Health Project, Indepth Network, Apartado 861, Bissau 1004, Guinea-Bissau.'}, {'ForeName': 'Lilica', 'Initials': 'L', 'LastName': 'Sanca', 'Affiliation': 'Bandim Health Project, Indepth Network, Apartado 861, Bissau 1004, Guinea-Bissau.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Clipet-Jensen', 'Affiliation': 'Research Center for Vitamins and Vaccines, Statens Serum Institut, Artillerivej 5, Copenhagen S 2300, Denmark.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Bandim Health Project, Indepth Network, Apartado 861, Bissau 1004, Guinea-Bissau.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Au', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Rm. G227-2211 Wesbrook Mall, Vancouver, BC Canada V6T 2B5.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Chipperfield', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Rm. G227-2211 Wesbrook Mall, Vancouver, BC Canada V6T 2B5.'}, {'ForeName': 'Tobias R', 'Initials': 'TR', 'LastName': 'Kollmann', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Rm 2D19, 4480 Oak Street, Vancouver, BC Canada V6H 3V4.'}, {'ForeName': 'Nelly A', 'Initials': 'NA', 'LastName': 'Amenyogbe', 'Affiliation': 'Department of Experimental Medicine, University of British Columbia, 2775 Laurel Street, Vancouver, BC Canada V5Z 1M9.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/traa023']
90,32322697,Resveratrol plus carboxymethyl-β-glucan in infants with common cold: A randomized double-blind trial.,"Objectives


To evaluate effectiveness of a nasal resveratrol/carboxymethyl-β-glucan solution compared to nasal saline solution: a) on common cold symptoms by means of a validated measure scale (CARIFS score), b) on Rhinovirus infection and CCL2, CCL5, IL8, IL6, CXCL10 and TLR2 expression in nasal swabs, c) on frequency of relapses after 30 days of follow-up.
Methods


89 infants with respiratory infection symptoms were randomly assigned to receive either a nasal resveratrol/carboxymethyl-β-glucan solution or nasal saline solution.All patients were evaluated with CARIFS score at enrollment, after 48 h, 7 and 30 days by physicians and parents. Nasal swabs were obtained at enrollment, after 48 h and after one week.
Results


CARIFS score improved in both groups. Episodes of sneezing and cough were fewer in study group after 7 days of follow-up (p < 0.05). No significant differences were found on nasopharyngeal swabs in Rhinovirus detection and cytokines expression after 48 h, nor in 30 days relapses. TLR2 expression was significantly higher in Rhinovirus infected children of the study group. No adverse effects occurred.
Conclusions


These data suggest that a solution containing resveratrol plus carboxymethyl-β-glucan might have a positive impact on both clinical and socio-economic burden due to infant common cold.",2020,Episodes of sneezing and cough were fewer in study group after 7 days of follow-up (p<001).,"['89 infants with respiratory infection symptoms', 'infants with common cold']","['nasal resveratrol/carboxymethyl-β-glucan solution', 'nasal saline solution', 'nasal resveratrol/carboxymethyl-β-glucan solution or nasal saline solution', 'Resveratrol plus carboxymethyl-β-glucan']","['TLR2 expression', 'Episodes of sneezing and cough', 'measure scale (CARIFS score), b) on Rhinovirus infection and CCL2, CCL5, IL8, IL6, CXCL10 and TLR2 expression in nasal swabs, c) on frequency of relapses', 'nasopharyngeal swabs in Rhinovirus detection and cytokines expression', 'CARIFS score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0754727', 'cui_str': 'TLR2 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0276447', 'cui_str': 'Disease due to Rhinovirus'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C1436337', 'cui_str': 'CCL5 protein, human'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0035473', 'cui_str': 'Rhinovirus'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",89.0,0.492629,Episodes of sneezing and cough were fewer in study group after 7 days of follow-up (p<001).,"[{'ForeName': 'Maria Elisabetta', 'Initials': 'ME', 'LastName': 'Baldassarre', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Mauro', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Labellarte', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Pignatelli', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Fanelli', 'Affiliation': 'Department of Interdisciplinary Medicine, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Schiavi', 'Affiliation': 'Department of Public Health and Infectious Disease, ""Sapienza"" University of Rome, Rome 00100, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mastromarino', 'Affiliation': 'Department of Public Health and Infectious Disease, ""Sapienza"" University of Rome, Rome 00100, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Capozza', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Panza', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Laforgia', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}]",Heliyon,['10.1016/j.heliyon.2020.e03814']
91,32330373,"Dietary supplementation with a novel l-carnitine multi-micronutrient in idiopathic male subfertility involving oligo-, astheno-, teratozoospermia: A randomized clinical study.","OBJECTIVE


To study the influence of a multi-component nutrient dietary supplement on sperm parameters and pregnancy rates in idiopathic male infertility (IMI) with oligo-, astheno-, and teratozoospermia.
DESIGN


A randomized, double-blind, placebo-controlled, prospective, parallel arms (1:1 allocation ratio), multi-center clinical trial.
SETTINGS


Eight urology/reproductive health clinical centers located in Ukraine.
PATIENTS


Eighty-three males aged 21-50 years with IMI and at least 1 of 3 abnormal values: total sperm concentration < 15 million/ml or/and spermatozoa progressive motility < 32% or/and forms with normal morphology < 4%.
INTERVENTION(S)


Patients were randomly allocated verum test dietary supplement (TDS) containing l-carnitine/acetyl-l-carnitine, l-arginine, glutathione, co-enzyme Q10, zinc, vitamin B 9  , vitamin B 12  , selenium, or placebo 1 time daily for 6 months.
MAIN OUTCOME(S)


The primary outcome measure was the percentage of normal spermiograms (concentration ≥ 15 million/ml and ≥ 32% of spermatozoa with progressive motility and ≥ 4% of normal forms) at month 0, 2, and 4. The percentage of pregnancies served the secondary outcome endpoint. Differences between the groups were assessed in z-test for proportions.
RESULTS


All males finished the study. At month 4, 29/42 (69.0%) males in the verum and 9/41 (22.0%) had normal spermiograms (P < .001). The percentage of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = .017). There were no reportable supplement-associated adverse events.
CONCLUSION


Specific multi-nutrient combination l-carnitine/l-acetyl-carnitine, l-arginine, glutathione, co-enzyme-Q, zinc, folic acid, cyanocobalamin, and selenium can improve sperm quality in males with IMI and increase pregnancy rates.",2020,"Percent of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = 0.017).","['Eight urology/reproductive health clinical centers located in Ukraine', 'males with IMI and increase pregnancy rates', 'idiopathic male subfertility involving oligo-, astheno-, teratozoospermia', 'Eighty-three males aged 21-50 years with IMI and at least 1 of 3 abnormal values: total sperm concentration < 15 million/ml or/and spermatozoa progressive motility < 32% or/and forms with normal morphology <4', 'idiopathic male infertility (IMI) with oligo-, astheno-, teratozoospermia']","['Specific multi-nutrient combination L-carnitine/ L-acetyl-carnitine, L-arginine, glutathione, co-enzyme-Q, zinc, folic acid, cyanocobalamin, and selenium', 'multicomponent nutrient dietary supplement', 'placebo', 'Dietary supplementation with a novel L-carnitine multi-micronutrient', 'verum test dietary supplement (TDS) containing L-carnitine/acetyl-L-carnitine, L-arginine, glutathione, co-enzyme-Q10, zinc, vitamin B 9  , vitamin B 12  , selenium or placebo']","['normal spermiograms', 'sperm parameters and pregnancy rates', 'spontaneous pregnancies', 'sperm quality', 'percentage of normal spermiograms (concentration ≥ 15 million/ml and ≥ 32% of spermatozoa with progressive motility and ≥ 4% of normal forms']","[{'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0848676', 'cui_str': 'Sub-Fertility, Male'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0403824', 'cui_str': 'Teratozoospermia'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C1960956', 'cui_str': 'Million/milliliter'}, {'cui': 'C3854382', 'cui_str': 'Spermatozoa progressive motility'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0085798', 'cui_str': 'Glycogen Branching Enzyme'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1960956', 'cui_str': 'Million/milliliter'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",83.0,0.423096,"Percent of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = 0.017).","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kopets', 'Affiliation': 'Medical Center ""Astar"", Lviv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Kuibida', 'Affiliation': 'Precarpathian Center of Reproductive Health, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Chernyavska', 'Affiliation': 'Mykolaiv State Clinical Hospital, Mykolaiv, Ukraine.'}, {'ForeName': 'Vasyl', 'Initials': 'V', 'LastName': 'Cherepanyn', 'Affiliation': 'Lviv State Center for the Reproductive Health, Lviv, Ukraine.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Mazo', 'Affiliation': 'Private Urologic Practice, Mykolaiv, Ukraine.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Fedevych', 'Affiliation': 'Lviv State Hospital, Lviv, Ukraine.'}, {'ForeName': 'Sergiy', 'Initials': 'S', 'LastName': 'Gerasymov', 'Affiliation': 'MedianaStatistics, Lviv, Ukraine.'}]",Andrology,['10.1111/andr.12805']
92,31578136,Efficacy of zinc supplementation in the management of acute diarrhoea: a randomised controlled trial.,"Background : Zinc has been recommended for the treatment of acute diarrhoea; however, there are heterogeneous reports regarding its efficacy. Aim : This study investigated the efficacy of zinc supplementation on the treatment outcomes of children admitted to hospital with acute diarrhoea. Methods : A double-blind, randomised, placebo-controlled trial was conducted in the Srinakharinwirot University Hospital's Paediatric Department, Thailand. Eligible children were randomly allocated to receive either zinc bisglycinate (15 mg elemental zinc) or a placebo. The study protocol was registered in the Thai Clinical Trials Registry (TCTR20190423004). Results : Of 86 patients, 50 (58.1%) were male and the mean age (range) was 2.5 years (6 months to 9.3 years). The median (IQR) number of hours to recovery from diarrhoea was significantly less in the zinc group than in the controls [44 (24-48)  vs  52 (36-80) hours, respectively,  p <  0.01]. The median (IQR) number of stools was significantly lower in the zinc group [5 (3-12)] than in the controls [7 (4-17),  p  = 0.02]. The median (IQR) duration of intravenous fluid therapy was 40 (24-56) hours in the zinc group and 56 (40-73) in the control group ( p  < 0.01). The duration of hospitalisation was 60 (44-72) hours in the zinc group and 84 (56-136) hours in the controls ( p <  0.01). There was good compliance by all participants in both groups. Conclusion : Zinc supplementation can reduce the time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools. Zinc supplementation is recommended as a routine strategy for Thai children with acute diarrhoea.",2020,"Zinc supplementation can reduce the time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools.","['Eligible children', 'Of 86 patients, 50 (58.1%) were male and the mean age (range) was 2.5\xa0years (6\xa0months to 9.3\xa0years', 'children admitted to hospital with acute diarrhoea', ""Srinakharinwirot University Hospital's Paediatric Department, Thailand"", 'Thai children with acute diarrhoea', 'acute diarrhoea']","['zinc supplementation', ' ', 'placebo', 'zinc bisglycinate', 'Zinc supplementation']","['duration of hospitalisation', 'median (IQR) number of stools', 'time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools', 'median (IQR) duration of intravenous fluid therapy', 'median (IQR) number of hours to recovery from diarrhoea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0337910', 'cui_str': 'Thai'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action (observable entity)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",86.0,0.388735,"Zinc supplementation can reduce the time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools.","[{'ForeName': 'Lakkana', 'Initials': 'L', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Preventive Medicine, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Sanguansak', 'Initials': 'S', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}]",Paediatrics and international child health,['10.1080/20469047.2019.1673548']
93,32329198,Influence of low-level laser therapy on implant stability in implants placed in fresh extraction sockets: A randomized clinical trial.,"BACKGROUND


Low-level laser therapy (LLLT) has been suggested to improve primary stability at the early stages of osseointegration in animal models. However, there is still scarce evidence about its influence on implant stability in humans.
PURPOSE


To assess the influence of LLLT on implant stability in implants placed in fresh extraction sockets.
MATERIAL AND METHODS


A randomized controlled trial was designed according to the SPIRIT guidelines and is reported following the CONSORT. Patients were randomly allocated according to control or LLLT groups. LLLT consisted in the application of GaAlAs laser (808 nm, avg. power density: 50 mW, circular spot diameter and area: 0.71 cm/0.4cm 2  ) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing. The total dose resulted in 66 J per application moment. This LLLT protocol was applied only in the dental implant placement session. Implant stability was by ISQ at implant placement (T 0  ) and the abutment selection (T a  ). Digital radiographs for T 0  and T a  were used to assess the distance between the implant platform and alveolar bone crest, in millimeters. T-test and Shapiro-Wilk test were used to analyze data between groups using the implant as a unit of analysis.
RESULTS


Fifty implants were placed in 44 patients. The insertion torque ranged from 15 to 60 N.cm (mean 35.64 ± 13.34). Two implants of the LLLT and one of the control groups were lost to follow-up and one implant of the control group failed to osseointegrate (4.3%). ISQ at T 0  ranged from 17 to 79 (mean 59.33 ± 13.05) and from 40 to 89 (mean 66.46 SD ± 11.56) at T a  . No differences were observed when comparing the groups with ISQ difference (P = .433) or radiographical peri-implant alterations (P = .261).
CONCLUSIONS


LLLT did not influence implant stability in implants placed in fresh extraction sockets when assessed at healing abutment installation.",2020,"No differences were observed when comparing the groups with ISQ difference (P = .433) or radiographical peri-implant alterations (P = .261).
","['implants placed in fresh extraction sockets', 'Fifty implants were placed in 44 patients']","['LLLT', 'GaAlAs laser', 'low-level laser therapy', 'control or LLLT', 'Low-level laser therapy (LLLT']","['Implant stability', 'implant stability', 'Digital radiographs for T 0  and T', 'ISQ']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",50.0,0.0889852,"No differences were observed when comparing the groups with ISQ difference (P = .433) or radiographical peri-implant alterations (P = .261).
","[{'ForeName': 'Renan Pablo Bittencourt', 'Initials': 'RPB', 'LastName': 'Lobato', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mateus de Azevedo', 'Initials': 'MA', 'LastName': 'Kinalski', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Thiago Marchi', 'Initials': 'TM', 'LastName': 'Martins', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Bernardo Antonio', 'Initials': 'BA', 'LastName': 'Agostini', 'Affiliation': 'Graduate Program in Dentistry, Meridional Faculty/IMED, Passo Fundo, Brazil.'}, {'ForeName': 'Cesar Dalmolin', 'Initials': 'CD', 'LastName': 'Bergoli', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mateus Bertolini Fernandes', 'Initials': 'MBF', 'LastName': 'Dos Santos', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}]",Clinical implant dentistry and related research,['10.1111/cid.12904']
94,30926955,"Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.","BACKGROUND


Some weight loss medications, including liraglutide 3.0 mg, are thought to facilitate weight loss by improving appetite control. However, no studies have evaluated their long-term appetitive effects.
SUBJECTS/METHODS


This study examined changes in appetite in a subsample of 113 adults with obesity (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) who participated in a 52-week trial. Participants were randomized to intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0 mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). Participants rated their hunger, fullness after meals, liking of meals, and food preoccupation (all as experienced over the past week) using visual analogue scales (0-100 mm). Ratings were completed at baseline and eight subsequent visits over the year.
RESULTS


At week 52, participants treated by IBT-alone lost 6.2 ± 1.6% of baseline weight, compared with 11.8 ± 1.6% and 12.1 ± 1.5% in the IBT-liraglutide and Multi-component groups, respectively. Compared to IBT-alone, IBT-liraglutide participants reported larger reductions at week 6 in hunger (-0.3 ± 4.2 vs -16.8 ± 4.0 mm, p = .005) and food preoccupation (+0.2 ± 3.7 vs -16.3 ± 3.6 mm, p = .002) and larger increases in fullness (-5.1 ± 3.2 vs +9.8 ± 3.0 mm, p = .001). These significant differences persisted at all assessments through week 24. There were no differences between IBT-alone and IBT-liraglutide in meal liking. IBT-alone and Multi-component participants differed in hunger at week 6, and in food preoccupation at all assessments through week 24. Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively. There were no other differences among any groups at week 52.
CONCLUSIONS


Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.",2020,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","['113 adults with obesity (76.1% female, 55.8% white, BMI\u2009=\u200938.8\u2009±\u20094.8\u2009kg/m 2 ) who participated in a 52-week trial']","['intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0\u2009mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'IBT-alone, IBT-liraglutide', 'IBT-alone and Multi-component', 'IBT-liraglutide', 'liraglutide']","['hunger, fullness, and food preoccupation', 'liking of meals relative', 'hunger, fullness after meals, liking of meals, and food preoccupation', 'fullness', 'weight losses', 'food preoccupation', 'appetite', 'visual analogue scales', 'appetite, food preoccupation, and food liking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",113.0,0.0597185,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zayna M', 'Initials': 'ZM', 'LastName': 'Bakizada', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0348-6']
95,31733140,Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.,"BACKGROUND


Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis.
METHODS


We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed.
RESULTS


A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P = 0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P = 0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P = 0.03).
CONCLUSIONS


Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo. (Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov number, NCT02551094.).",2019,"The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization.","['patients with a recent myocardial infarction', 'A total of 4745 patients were enrolled; 2366 patients', 'patients recruited within 30 days after a myocardial infarction']","['Low-Dose Colchicine', 'Colchicine', 'placebo', 'colchicine', 'low-dose colchicine']","['resuscitated cardiac arrest', 'Diarrhea', 'composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization', 'hazard ratios', 'Pneumonia', 'ischemic cardiovascular events', 'Efficacy and Safety', 'myocardial infarction', 'serious adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction (situation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2366.0,0.670027,"The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization.","[{'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kouz', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Waters', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Fausto J', 'Initials': 'FJ', 'LastName': 'Pinto', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Gamra', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Ghassan S', 'Initials': 'GS', 'LastName': 'Kiwan', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Angoulvant', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Grégoire', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Lavoie', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rhainds', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Mylène', 'Initials': 'M', 'LastName': 'Provencher', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Blondeau', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Orfanos', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': ""L'Allier"", 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Guertin', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}]",The New England journal of medicine,['10.1056/NEJMoa1912388']
96,32389679,Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools.,"Solar ultraviolet radiation (UV) exposure is the primary risk factor for skin cancer and children receive about one-quarter of lifetime UV exposure before age 18. Thus, skin cancer prevention is essential for children. The objective of this study was to test an intervention to facilitate implementation of district sun safety policies. Elementary schools (N = 118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school. Elementary schools were randomly assigned to receive the 20-month Sun Safe Schools intervention (N = 58) or to a minimal informational control condition (N = 60). Principals were 47.8 and teachers 44.3 years of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2%). The 20-month Sun Safe Schools intervention was delivered to principals and included a coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program. The principal (N = 118) and a teacher (N = 113) at each school reported on school sun protection practices 20-months post-baseline. The schools were diverse in student characteristics (M = 64.1% free/reduced price meals; M = 54.5% Hispanic). Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control M = 0.4, intervention M = 0.9, p = .005). Principals and teachers combined replicated these findings and also reported implementing more practices present in the district policy (control M = 0.9, intervention M = 1.3, p = .005). In sum, the intervention increased sun safety practices in public elementary schools. Trial Registration. This study is registered in ClinicalTrials.gov, www.clinicaltrials.gov, with the identification number of NCT03243929.",2020,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","['Principals were 47.8 and teachers 44.3\u202fyears of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2', 'California public elementary schools', 'Elementary schools (N\u202f=\u202f118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school', 'Elementary schools']","['Solar ultraviolet radiation (UV) exposure', '20-month Sun Safe Schools intervention (N\u202f=\u202f58) or to a minimal informational control condition', 'coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program']","['sun safety practices', 'sun safety practices overall']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0636129,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA. Electronic address: Kim.Reynolds@cgu.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, 2625 W. Alameda Ave., Suite 517, Burbank, CA 91505, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR 97227, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106125']
97,32396131,A Sexual Health Promotion App for Transgender Women (Trans Women Connected): Development and Usability Study.,"BACKGROUND


HIV severely impacts the transgender communities in the United States, and transgender women have the highest HIV incidence rates among any identified risk group. Guided by formative research with transgender women and by an expert advisory panel of transgender women, we designed a prototype mobile app to promote HIV prevention among transgender women.
OBJECTIVE


This study aimed to develop and test the usability and acceptability of the prototype Trans Women Connected mobile app.
METHODS


We engaged in a 3-phase prototype development process. After conducting formative research about the health needs of this population, we outlined a theory-based app framework and developed three prototype activities (ie, a vision board, a pre-exposure prophylaxis [PrEP] education activity, and an interactive map). We then tested the usability and acceptability of the mobile app and activities with 16 transgender women using pre- and posttests, think-aloud protocols, and open-ended questions.
RESULTS


Participants reported high acceptability for the mobile app; the mean rating across all usability and likability questions was 5.9 out of 7. Service utilization intention, goal setting, and social support increased at posttest compared with pretest. Increases in self-efficacy in finding lesbian, gay, bisexual, transgender, and queer-friendly services; intention to seek online social support; and PrEP knowledge were statistically significant. Participants described the app as attractive and useful and perceived all three activities positively.
CONCLUSIONS


This study describes the development and usability and acceptability evaluation of a prototype mobile app designed for and with transgender women for HIV prevention. The usability testing findings provided important insights toward refining and the further development of the Trans Women Connected mobile app. The results suggest that a mobile health intervention can support positive changes. The remaining development and efficacy randomized trial of the Trans Women Connected mobile app is currently underway.",2020,"Service utilization intention, goal setting, and social support increased at posttest compared with pretest.","['transgender women for HIV prevention', 'Transgender Women (Trans Women Connected']","['prototype Trans Women Connected mobile app', 'mobile health intervention']","['mean rating across all usability and likability questions', 'Service utilization intention, goal setting, and social support', 'usability and acceptability', 'self-efficacy']","[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",16.0,0.0849745,"Service utilization intention, goal setting, and social support increased at posttest compared with pretest.","[{'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Sun', 'Affiliation': 'School of Public Health, Oregon Health & Science University-Portland State University, Portland, OR, United States.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Anderson', 'Affiliation': 'School of Public Health, Oregon Health & Science University-Portland State University, Portland, OR, United States.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Kuhn', 'Affiliation': 'dfusion, Scotts Valley, CA, United States.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Mayer', 'Affiliation': 'Department of Anthropology, Portland State University, Portland, OR, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Klein', 'Affiliation': 'Department of Anthropology, Portland State University, Portland, OR, United States.'}]",JMIR mHealth and uHealth,['10.2196/15888']
98,32335132,Short Durations of Radial Hemostatic Device After Diagnostic Transradial Cardiac Catheterization: The PRACTICAL-2 Randomized Trial.,"BACKGROUND


Radial artery occlusion (RAO) is the most common complication following transradial approach (TRA) for cardiac catheterisation. Our aim was to assess if decreasing radial hemostatic device (RHD) time reduces the risk of RAO among individuals receiving small sheath sizes with no adjunctive heparin.
METHODS


We randomised 450 individuals undergoing diagnostic cardiac catheterization via TRA to 3 durations of RHD time: 10, 20, or 30 minutes. After these time periods, the RHD was gradually released over 20 minutes. The primary efficacy end point was forearm hematoma grade ≥ 2 (5-10 cm) and the primary safety end point was RAO (as determined by Doppler ultrasound) 1 hour after RHD removal (before discharge).
RESULTS


The mean age was 66 years and 64% were male. Five-French sheaths were used in all patients. Hematoma grade ≥ 2 occurred in only 1 patient, who was in the 20-minute group (P = 0.39). RAO occurred in 6.7% of patients in the 10-minute group, 10.7% in the 20-minute group and 6% in the 30-minute group (P = 0.26).
CONCLUSIONS


Among patients receiving small-calibre sheaths without adjunctive heparin, the incidence of forearm hematoma and RAO are low. Shorter durations of RHD time did not further reduce the risk of these complications.",2020,"RAO occurred in 6.7% of patients in the 10 minute group, 10.7% in the 20 minute group and 6% in the 30 minute group (P=0.26).
","['450 individuals into 3 durations of RHD time: 10, 20 or 30 minutes', '450 individuals undergoing diagnostic cardiac catheterization via the TRA to 3 durations of RHD time: 10, 20 or 30 minutes', 'patients receiving small caliber sheaths without', 'individuals receiving small sheath sizes with no adjunctive heparin', 'patients undergoing cardiac catheterization via the trasradial approach while small size sheaths and no', 'The mean age was 66 years and 64% were male']","['heparin', 'adjunctive heparin', 'Radial artery occlusion (RAO', 'radial hemostatic device (RHD', 'radial hemostatic device post diagnostic transradial cardiac catheterization']","['radial hemostatic device (RHD) time decreases the risk of radial artery occlusion (RAO', 'incidence of forearm hematoma and RAO', 'RAO', 'Shorter durations of RHD time', 'forearm hematoma grade ≥2 (5-10 cm) and the primary safety endpoint was RAO (as determined by Doppler ultrasound) one-hour post RHD removal (pre-discharge', 'RHD', 'forearm hematoma and RAO', 'Hematoma grade ≥2']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0449964', 'cui_str': 'Size of introducer'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0752250', 'cui_str': 'Removal of device'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",450.0,0.283138,"RAO occurred in 6.7% of patients in the 10 minute group, 10.7% in the 20 minute group and 6% in the 30 minute group (P=0.26).
","[{'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Lavi', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada. Electronic address: shahar.lavi@lhsc.on.ca.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, Ontario, Canada.'}, {'ForeName': 'Rehana', 'Initials': 'R', 'LastName': 'Bajwa', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Taleb', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Shahrukh N', 'Initials': 'SN', 'LastName': 'Bakar', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ayaaz', 'Initials': 'A', 'LastName': 'Sachedina', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Wagner', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Solomonica', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kokab', 'Initials': 'K', 'LastName': 'Awan', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Klajdi', 'Initials': 'K', 'LastName': 'Puka', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Pallav', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Diamantouros', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bagur', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada; Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, Ontario, Canada.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.04.017']
99,32251813,Is Full Endoscopic Lumbar Discectomy Less Invasive Than Conventional Surgery? A Randomized MRI Study.,"BACKGROUND


In the present randomized prospective study, we compared the surgical invasiveness using a quantitative volumetric analysis of postoperative paravertebral muscle signal intensity changes between transforaminal full endoscopic lumbar discectomy (FELD) and open discectomy (OD).
METHODS


We prospectively collected the data from 50 patients with a single-level lumbar foraminal herniation, invalidating radicular pain, and adequate imaging studies available (postoperative magnetic resonance imaging [MRI] <24 hours). These patients had been randomly assigned to FELD (n = 25) or OD (n = 25). Data were collected on age, sex, leg and back pain, complications, and follow-up time. Muscle segmentations were performed manually using 3DSlicer software on postoperative isovolumetric T1-weighted contrast-enhanced and T2-weighted short tau inversion recovery MRI scans. Both sequences were processed using multiplanar reconstruction in orthogonal planes. The clinical and demographic characteristics and volumetric data were then compared between the 2 groups.
RESULTS


We found a higher mean volume of paravertebral muscle signal alterations among the OD-treated patients in both T2-weighted short tau inversion recovery MRI (P ≤ 0.001) and T1-weighted contrast-enhanced MRI (P ≤ 0.001) scans than among the FELD-treated patients. No differences were found between the median preoperative and postoperative leg pain between the 2 groups (P = 1.000). The median scores for postoperative back pain were significantly lower for the FELD group (P ≤ 0.001), as was the median interval from surgery to autonomous mobilization (P = 0.001).
CONCLUSIONS


We found a significant difference in signal intensity of the paravertebral muscles between the FELD and OD groups, reflective of the minor surgical invasiveness of endoscopic discectomy. FELD resulted in less trauma to the paraspinal muscles, possibly also reducing inflammatory cytokine release and, therefore, is a valuable tool for spinal surgeons.",2020,"Median values for postoperative back pain were significantly lower for FELD patients (p-value=<0.001), as long as the median time from operation to patients autonomous mobilization (p-value=0.001).
","['50 patients with a single-level lumbar foraminal herniation, an invalidating radicular pain, and adequate imaging (postoperative MRI < 24 hours']","['transforaminal full-endoscopic lumbar discectomy (FELD) and open discectomy (OD', 'FELD']","['median preoperative and postoperative leg pain', 'Median values for postoperative back pain', 'signal intensity of paravertebral muscles', 'mean volume of paravertebral muscle signal alterations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0441996', 'cui_str': 'Foraminal'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",50.0,0.066437,"Median values for postoperative back pain were significantly lower for FELD patients (p-value=<0.001), as long as the median time from operation to patients autonomous mobilization (p-value=0.001).
","[{'ForeName': 'Leonello', 'Initials': 'L', 'LastName': 'Tacconi', 'Affiliation': 'Neurosurgical Department, Azienda Sanitaria Universitaria Integrata di Trieste, Trieste, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Signorelli', 'Affiliation': 'Division of Neurosurgery, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University ""Aldo Moro"" of Bari, Bari, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Giordan', 'Affiliation': 'Neurosurgical Department, Azienda ULSS 2 Marca Trevigiana, Treviso, Veneto, Italy. Electronic address: enrico.giordan@aulss2.veneto.it.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.123']
100,32251871,"Public opinion and legislations related to brain death, circulatory death and organ donation.","BACKGROUND


It is poorly understood how public perception of the difference between brain death and circulatory death may influence attitudes towards organ donation. We investigated the public opinion on brain death versus circulatory death and documented inconsistencies in the legislations of countries with different cultural and socioeconomic backgrounds.
METHODS


Using a crowdsourcing approach, we randomized 1072 participants from 30 countries to a case report of organ donation after brain death or to one following circulatory death. Further, we sampled guidelines from 24 countries and 5 continents.
RESULTS


Of all participants, 73% stated they would be willing to donate all organs, while 16% would want to donate some of their organs. To increase the rate of donations, 47% would agree with organ donation without family consent as the default. Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11). However, participants exposed to ""circulatory death"" were more certain that the patient was truly dead (87.9% ± 19.7%) than participants exposed to ""brain death"" (84.1% ± 22.7%; Cohen's d 0.18; p = 0:004). Sampling of guidelines revealed large differences between countries regarding procedures required to confirm brain death and circulatory death, respectively.
CONCLUSIONS


Implementation of organ donation after circulatory death is unlikely to negatively influence the willingness to donate organs, but legislation is still brain death-based in most countries. The time seems ripe to increase the rate of circulatory death-based organ donation.",2020,"Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11).","['24 countries and 5 continents', '1072 participants from 30 countries to a case report of organ donation after brain death or to one following circulatory death']",[],"['rate of circulatory death-based organ donation', 'rate of donations', 'brain death and circulatory death', 'circulatory death']","[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",[],"[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}]",1072.0,0.124868,"Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11).","[{'ForeName': 'Marwan H', 'Initials': 'MH', 'LastName': 'Othman', 'Affiliation': 'Departments of Neurology, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Department of Biomedical Engineering, University at Buffalo, State University of New York, NY, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kondziella', 'Affiliation': 'Departments of Neurology, Rigshospitalet, Copenhagen University Hospital, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: daniel.kondziella@regionh.dk.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116800']
101,31690523,Randomized controlled trial of vacuum therapy for intermittent claudication.,"OBJECTIVE


The ""gold standard"" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program.
METHODS


IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life.
RESULTS


A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups.
CONCLUSIONS


IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.",2020,"Ambulatory ability and quality of life improved equally in both groups.
","['IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017', '78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n\xa0= 34; intervention, n\xa0= 36', 'IC patients undergoing a standardized SET program', 'intermittent claudication']","['intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure', 'Intermittent vacuum therapy (IVT', 'standardized SET program', 'vacuum therapy', 'supervised exercise therapy (SET', 'IVT']","['functional treadmill walking distance', 'negative pressure and atmospheric pressure', 'walking distance', 'change in maximal treadmill walking distance', 'change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life', 'Ambulatory ability and quality of life', 'Median (interquartile range) change in maximal treadmill walking distance', 'Mean\xa0± standard deviation change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0004180', 'cui_str': 'Atmospheric Pressure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034380'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",78.0,0.184491,"Ambulatory ability and quality of life improved equally in both groups.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hageman', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hugo J P', 'Initials': 'HJP', 'LastName': 'Fokkenrood', 'Affiliation': 'Department of Vascular Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Brit A C', 'Initials': 'BAC', 'LastName': 'van Deursen', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Lindy N M', 'Initials': 'LNM', 'LastName': 'Gommans', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Cancrinus', 'Affiliation': 'Department of Vascular Surgery, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'Marc R M', 'Initials': 'MRM', 'LastName': 'Scheltinga', 'Affiliation': 'Department of Vascular Surgery, Máxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Joep A W', 'Initials': 'JAW', 'LastName': 'Teijink', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands. Electronic address: joep.teijink@catharinaziekenhuis.nl.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.08.239']
102,31912785,Differential effects of an electronic symptom monitoring intervention based on the age of patients with advanced cancer.,"BACKGROUND


Symptom monitoring interventions enhance patient outcomes, including quality of life (QoL), health care utilization, and survival, but it remains unclear whether older and younger patients with cancer derive similar benefits. We explored whether age moderates the improved outcomes seen with an outpatient electronic symptom monitoring intervention.
PATIENTS AND METHODS


We carried out a secondary analysis of data from a randomized trial of 766 patients receiving chemotherapy for metastatic solid tumors. Patients received an electronic symptom monitoring intervention integrated with oncology care or usual oncology care alone. The intervention consisted of patients reporting their symptoms, which were provided to their physicians at clinic visits, and nurses receiving alerts for severe/worsening symptoms. We used regression models to determine whether age (older or younger than 70 years) moderated the effects of the intervention on QoL (EuroQol EQ-5D), emergency room (ER) visits, hospitalizations, and survival outcomes.
RESULTS


Enrollment rates for younger (589/777 = 75.8%) and older (177/230 = 77.0%) patients did not differ. Older patients (median age = 75 years, range 70-91 years) were more likely to have an education level of high school or less (26.6% versus 20.9%, P = 0.029) and to be computer inexperienced (50.3% versus 23.4%, P < 0.001) compared with younger patients (median age = 58 years, range 26-69 years). Younger patients receiving the symptom monitoring intervention experienced lower risk of ER visits [hazard ratio (HR) = 0.74, P = 0.011] and improved survival (HR = 0.76, P = 0.011) compared with younger patients receiving usual care. However, older patients did not experience significantly lower risk of ER visits (HR = 0.90, P = 0.613) or improved survival (HR = 1.06, P = 0.753) with the intervention. We found no moderation effects based on age for QoL and risk of hospitalizations.
CONCLUSIONS


Among patients with advanced cancer, age moderated the effects of an electronic symptom monitoring intervention on the risk of ER visits and survival, but not QoL. Symptom monitoring interventions may need to be tailored to the unique needs of older adults with cancer.",2020,"Younger patients receiving the symptom monitoring intervention experienced lower risk of ER visits [hazard ratio (HR) = 0.74, P = 0.011] and improved survival (HR = 0.76, P = 0.011) compared with younger patients receiving usual care.","['Older patients (median age\xa0= 75 years, range 70-91 years', 'younger patients (median age\xa0= 58 years, range 26-69 years', 'age (older or younger than 70 years', 'older and younger patients with cancer', '766 patients receiving chemotherapy for metastatic solid tumors', 'patients with advanced cancer', 'older adults with cancer']","['electronic symptom monitoring intervention', 'electronic symptom monitoring intervention integrated with oncology care or usual oncology care alone']","['survival', 'QoL (EuroQol EQ-5D), emergency room (ER) visits, hospitalizations, and survival outcomes', 'quality of life (QoL), health care utilization, and survival', 'risk of ER visits']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0034380'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",766.0,0.0472507,"Younger patients receiving the symptom monitoring intervention experienced lower risk of ER visits [hazard ratio (HR) = 0.74, P = 0.011] and improved survival (HR = 0.76, P = 0.011) compared with younger patients receiving usual care.","[{'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA. Electronic address: RNipp@MGH.Harvard.edu.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Horick', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Rogak', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fuh', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Scottsdale, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.09.003']
103,31455832,Effects of deep neuromuscular blockade on the stress response during laparoscopic gastrectomy Randomized controlled trials.,"Maintaining deep neuromuscular block during surgery improves surgical space conditions. However, its effects on patient outcomes have not been well documented. We examined whether maintaining deep neuromuscular blockade during surgery could decrease the stress response compared to moderate neuromuscular blockade. Patients undergoing laparoscopic gastrectomy were randomly allocated to either the moderate (train-of-four counts of 1-2) or deep (post-tetanic counts of 1-2) neuromuscular blockade group. The primary outcome variable was the postoperative blood level of interleukin-6, and the secondary outcome variables were intraoperative or postoperative blood levels of tumor necrosis factor-α, interleukin-1β, interleukin-8, and C-reactive protein. A total of 96 patients were recruited and 88 (44 in each group) were included in the analyses. The levels of tumor necrosis factor-α and interleukin-1β measured at the end of surgery, interleukin-6 and interleukin-8 measured at 2 h postoperatively, and C-reactive protein measured at 48 h postoperatively were all significantly increased compared to the preoperative values, but there were no differences between the moderate and deep neuromuscular block groups. We found no differences in surgical stress response measured using determining levels of interleukin-6 and other mediators released between the moderate and deep neuromuscular blockade groups in patients undergoing laparoscopic gastrectomy.",2019,We found no differences in surgical stress response measured using determining levels of interleukin-6 and other mediators released between the moderate and deep neuromuscular blockade groups in patients undergoing laparoscopic gastrectomy.,"['Patients undergoing laparoscopic gastrectomy', 'A total of 96 patients were recruited and 88 (44 in each group) were included in the analyses', 'patients undergoing laparoscopic gastrectomy']","['deep neuromuscular blockade', 'neuromuscular blockade group']","['surgical stress response', 'postoperative blood level of interleukin-6', 'levels of tumor necrosis factor-α and interleukin-1β measured at the end of surgery, interleukin-6 and interleukin-8 measured at 2\u2009h postoperatively, and C-reactive protein', 'stress response', 'intraoperative or postoperative blood levels of tumor necrosis factor-α, interleukin-1β, interleukin-8, and C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",96.0,0.306369,We found no differences in surgical stress response measured using determining levels of interleukin-6 and other mediators released between the moderate and deep neuromuscular blockade groups in patients undergoing laparoscopic gastrectomy.,"[{'ForeName': 'Bon-Wook', 'Initials': 'BW', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Ah-Young', 'Initials': 'AY', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. ohahyoung@hanmail.net.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Yea-Ji', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Sun-Woo', 'Initials': 'SW', 'LastName': 'Nam', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Do-Jung', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwang-Suk', 'Initials': 'KS', 'LastName': 'Seo', 'Affiliation': 'Department of Dental Anesthesiology, Seoul National University Dental Hospital, Seoul, Korea.'}]",Scientific reports,['10.1038/s41598-019-48919-2']
104,32325490,"Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial.","Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The addition of daratumumab (D) to RVd (D-RVd) in transplant-eligible NDMM patients was evaluated. Patients (N = 207) were randomized 1:1 to D-RVd or RVd induction (4 cycles), ASCT, D-RVd or RVd consolidation (2 cycles), and lenalidomide or lenalidomide plus D maintenance (26 cycles). The primary end point, stringent complete response (sCR) rate by the end of post-ASCT consolidation, favored D-RVd vs RVd (42.4% vs 32.0%; odds ratio, 1.57; 95% confidence interval, 0.87-2.82; 1-sided P = .068) and met the prespecified 1-sided α of 0.10. With longer follow-up (median, 22.1 months), responses deepened; sCR rates improved for D-RVd vs RVd (62.6% vs 45.4%; P = .0177), as did minimal residual disease (MRD) negativity (10-5 threshold) rates in the intent-to-treat population (51.0% vs 20.4%; P < .0001). Four patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group progressed; respective 24-month progression-free survival rates were 95.8% and 89.8%. Grade 3/4 hematologic adverse events were more common with D-RVd. More infections occurred with D-RVd, but grade 3/4 infection rates were similar. Median CD34+ cell yield was 8.2 × 106/kg for D-RVd and 9.4 × 106/kg for RVd, although plerixafor use was more common with D-RVd. Median times to neutrophil and platelet engraftment were comparable. Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT02874742.",2020,There was no difference in median times to neutrophil or platelet engraftment.,"['ASCT-eligible NDMM patients', 'patients with transplant-eligible NDMM', 'Patients (N=207', 'Transplant-eligible Newly Diagnosed Multiple Myeloma', 'transplant-eligible patients with newly diagnosed multiple myeloma (NDMM']","['RVd ±D induction (4 cycles), ASCT, RVd ±D consolidation (2 cycles), and lenalidomide ±D maintenance', 'Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT', 'Daratumumab, Lenalidomide, Bortezomib, & Dexamethasone', 'plerixafor']","['median times to neutrophil or platelet engraftment', 'stringent complete response (sCR) rate', 'Median CD34+ cell yield', 'depth of response', '24-month progression-free survival rates', 'Grade 3/4 hematologic adverse events', 'minimal residual disease negativity']","[{'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",207.0,0.136648,There was no difference in median times to neutrophil or platelet engraftment.,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Laubach', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, School of Medicine, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology and Oncology, School of Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Silbermann', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Anderson', 'Affiliation': 'Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Yvonne A', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Holstein', 'Affiliation': 'Division of Oncology & Hematology, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Costello', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Wildes', 'Affiliation': 'Section of Medical Oncology, Division of Oncology, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Shain', 'Affiliation': 'Department of Malignant Hematology, H. Lee Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cowan', 'Affiliation': 'Division of Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Lutska', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA; and.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'de Boer', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hoehn', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Lin', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Blood,['10.1182/blood.2020005288']
105,32324444,Revisiting Reliability: Using Sampling Utterances and Grammatical Analysis Revised (SUGAR) to Compare 25- and 50-Utterance Language Samples.,"Purpose The goal of this study was to determine whether the results obtained from a 25-utterance conversational language sample were as reliable as those obtained from a 50-utterance sample. Method Robust conversational language samples from 220 children with typically developing language (106 boys, 114 girls) ranging in age from 3;2 to 7;10 (years;months) were collected. The language samples were randomly assigned to one of two conditions: a 25-utterance condition and a 50-utterance condition. Transcripts were examined for three metrics, including mean length of utterance SUGAR , words per sentence, and clauses per sentence. Results Data were analyzed using two methods. A linear mixed-model analysis was used to assess absolute and relative reliability, and the Bland-Altman procedure was used to assess absolute reliability and clinical acceptability. Results of the mixed-model analysis indicated that mean length of utterance SUGAR  and words per sentence demonstrated relative reliability; however, none of the metrics demonstrated absolute reliability. In contrast, results of the Bland-Altman scatter plots indicated that all three metrics demonstrated absolute reliability because 94%-96% of participants' scores fell within the limits of agreement. Taken together, the results suggested that the statistically significant differences indicated by the mixed-model analysis were not clinically significant. Conclusion These results highlighted the importance of using different methods of analysis in studies of reliability. The findings indicated that reliable language sample results can be obtained from 25-utterance samples. Furthermore, by including practices already in use (e.g., collecting samples ≤ 50 utterances) and including only minimal changes to current practices, the methods used in this study are feasible for school-based clinicians, could be easily integrated into clinical practice, and could increase the use of evidence-based assessment practices in schools.",2020,"Results of the mixed-model analysis indicated that mean length of utterance SUGAR  and words per sentence demonstrated relative reliability; however, none of the metrics demonstrated absolute reliability.","['220 children with typically developing language (106 boys, 114 girls) ranging in age from 3;2 to 7;10 (years;months) were collected']",['Sampling Utterances and Grammatical Analysis Revised (SUGAR'],"['absolute reliability and clinical acceptability', 'mean length of utterance SUGAR  and words per sentence demonstrated relative reliability', 'mean length of utterance SUGAR , words per sentence, and clauses per sentence']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",220.0,0.047942,"Results of the mixed-model analysis indicated that mean length of utterance SUGAR  and words per sentence demonstrated relative reliability; however, none of the metrics demonstrated absolute reliability.","[{'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Pavelko', 'Affiliation': 'Master of Science for Speech-Language Pathology Program, University of St. Augustine for Health Sciences, Dallas, TX.'}, {'ForeName': 'Larry R', 'Initials': 'LR', 'LastName': 'Price', 'Affiliation': 'Methodology, Measurement and Statistical Analysis, Office of Research and Sponsored Programs, Texas State University, San Marcos.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Owens', 'Affiliation': 'Department of Communication Sciences and Disorders, The College of Saint Rose, Albany, NY.'}]","Language, speech, and hearing services in schools",['10.1044/2020_LSHSS-19-00026']
106,32387007,Intramuscular Versus Buccal Midazolam for Pediatric Seizures: A Randomized Double-Blinded Trial.,"BACKGROUND


We compared the efficacy and safety of intramuscular with buccal midazolam as first-line treatment for active seizures in children brought to the emergency department.
METHODS


In a double-blind, double-dummy randomized trial, patients with an active seizure lasting more than five minutes received blinded treatments on arrival. We employed deferred consent. The proportion of patients with cessation of seizure within five minutes of drug administration was the primary efficacy outcome; proportions needing additional medication to control seizure, duration of seizure activity, and side effects were secondary outcomes.
RESULTS


We enrolled 150 children presenting with active seizure, age range 4.5 to 167.5 months. Cessation of seizure occurred in 61% of the intramuscular and 46% of the buccal treatment groups, (P = 0.07, difference 15.5%, 95% confidence interval for the difference -1.0 to 32.0%). Proportions requiring additional anti-seizure treatment were 39% in the intramuscular and 51% in the buccal groups. Mean duration of seizure activity after administration of study medication was 15.9 minutes (S.D. 28.7) in the intramuscular and 17.8 minutes (S.D. 27.5) in the buccal group. One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
CONCLUSIONS


Efficacy and safety of intramuscular midazolam as first-line treatment for pediatric seizures compare favorably to that of buccal midazolam.",2020,"One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
","['150 children presenting with active seizure, age range 4.5 to 167.5\xa0months', 'active seizures in children brought to the emergency department', 'Pediatric Seizures', 'patients with an active seizure lasting more than five\xa0minutes received blinded treatments on arrival']","['buccal midazolam', 'Intramuscular Versus Buccal Midazolam', 'midazolam']","['efficacy outcome; proportions needing additional medication to control seizure, duration of seizure activity, and side effects', 'Proportions requiring additional anti-seizure treatment', 'efficacy and safety', 'respiratory depression and hypotension', 'Mean duration of seizure activity', 'Cessation of seizure']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0730597', 'cui_str': 'Duration of seizure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",150.0,0.442737,"One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Alansari', 'Affiliation': 'Department of Emergency Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine - Qatar, Doha, Qatar. Electronic address: dkmaa@hotmail.com.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Barkat', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'AbdelNasir H', 'Initials': 'AH', 'LastName': 'Mohamed', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Shahaza Alali', 'Initials': 'SA', 'LastName': 'Al Jawala', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Shadi Ahmad', 'Initials': 'SA', 'LastName': 'Othman', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.03.011']
107,32396917,"Improving Cost-effectiveness and Access to Cognitive Behavior Therapy for Depression: Providing Remote-Ready, Computer-Assisted Psychotherapy in Times of Crisis and Beyond.","INTRODUCTION


There is growing evidence that computer-delivered or computer-assisted forms of cognitive behavior therapy (CCBT) are helpful, but cost-effectiveness versus standard therapies is not well established.
OBJECTIVE


To evaluate the cost-effectiveness of a therapist-supported method for CCBT in comparison to standard cognitive behavior therapy (CBT).
METHODS


A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact). Outcomes were assessed at baseline, weeks 8 and 16, and at 3 and 6 months post-treatment. Economic analyses took into account the costs of services received and work/social role impairment.
RESULTS


In the context of almost identical efficacy, a form of CCBT that used only about one third the amount of therapist contact as conventional CBT was highly cost-effective compared to conventional therapy and reduced the adjusted cost of treatment by USD 945 per patient.
CONCLUSIONS


A method of CCBT that blended internet-delivered modules and abbreviated therapeutic contact reduced the cost of treatment substantially without adversely affecting outcomes. Results suggest that use of this approach can more than double the access to CBT. Because clinician support in CCBT can be provided by telephone, videoconference, and/or email, this highly efficient form of treatment could be a major advance in remote treatment delivery.",2020,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"['154 drug-free major depressive disorder outpatients', 'Depression']","['cognitive behavior therapy (CCBT', 'Cognitive Behavior Therapy', 'therapist-supported method for CCBT', 'CCBT', 'standard cognitive behavior therapy (CBT', 'standard CBT']",['cost-effectiveness'],"[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0290312,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's College, London, United Kingdom.""}, {'ForeName': 'Marna S', 'Initials': 'MS', 'LastName': 'Barrett', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tracy D', 'Initials': 'TD', 'LastName': 'Eells', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jesse H', 'Initials': 'JH', 'LastName': 'Wright', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000508143']
108,32105625,"Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial.","BACKGROUND


Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment and care outcomes for adults on antiretroviral therapy (ART) when compared with standard laboratory viral load testing.
METHODS


We did an open-label, non-inferiority, randomised controlled trial in a public clinic in Durban, South Africa. We enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation. Individuals were randomly assigned by a random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). The primary outcome was combined viral suppression (<200 copies per mL) and retention at 12 months after enrolment. A non-inferiority margin of 10% was used. Analysis was done by intention to treat. This study was registered with ClinicalTrials.gov, NCT03066128.
FINDINGS


Between Feb 24, 2017, and Aug 23, 2017, we screened 657 participants, and 390 were enrolled and randomly assigned to either the intervention group (n=195) or standard-of-care group (n=195). 175 (90%) individuals in the intervention group and 148 (76%) individuals in the standard-of-care group had the primary outcome of retention with viral suppression, a difference of 13·9% (95% CI 6·4-21·2; p<0·00040). 182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026). There were no adverse events related to point-of-care HIV viral load testing or task shifting.
INTERPRETATION


Point-of-care viral load testing combined with task shifting significantly improved viral suppression and retention in HIV care. Point-of-care testing can simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings.
FUNDING


National Institute of Allergy and Infectious Diseases.",2020,"182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026).","['adults on antiretroviral therapy (ART', '657 participants, and 390 were enrolled', 'Between Feb 24, 2017, and Aug 23, 2017', 'public clinic in Durban, South Africa', 'enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation', 'HIV-positive adults receiving ART in resource-limited settings']","['random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group', 'intervention group (n=195) or standard-of-care group']","['viral suppression and retention in HIV care', 'viral suppression', 'retention with viral suppression', 'combined viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",657.0,0.288793,"182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026).","[{'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA; Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA. Electronic address: pkdrain@uw.edu.'}, {'ForeName': 'Jienchi', 'Initials': 'J', 'LastName': 'Dorward', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Violette', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Samsunder', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Ngobese', 'Affiliation': 'Prince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, South Africa.'}, {'ForeName': 'Koleka', 'Initials': 'K', 'LastName': 'Mlisana', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa.'}, {'ForeName': 'Pravikrishnen', 'Initials': 'P', 'LastName': 'Moodley', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa; Department of Virology, Inkosi Albert Luthuli Central Hospital, Cato Manor, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; CAPRISA-MRC HIV-TB Pathogenesis and Treatment Research Unit, and Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Salim S', 'Initials': 'SS', 'LastName': 'Abdool Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Garrett', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30402-3']
109,31791665,"The renal hemodynamic effects of the SGLT2 inhibitor dapagliflozin are caused by post-glomerular vasodilatation rather than pre-glomerular vasoconstriction in metformin-treated patients with type 2 diabetes in the randomized, double-blind RED trial.","Sodium-glucose cotransporter 2 inhibitors (SGLT2i) improve hard renal outcomes in type 2 diabetes. This is possibly explained by the fact that SGLT2i normalize the measured glomerular filtration rate (mGFR) by increasing renal vascular resistance, as was shown in young people with type 1 diabetes and glomerular hyperfiltration. Therefore, we compared the renal hemodynamic effects of dapagliflozin with gliclazide in type 2 diabetes. The mGFR and effective renal plasma flow were assessed using inulin and para-aminohippurate clearances in the fasted state, during clamped euglycemia (5 mmol/L) and during clamped hyperglycemia (15 mmol/L). Filtration fraction and renal vascular resistance were calculated. Additionally, factors known to modulate renal hemodynamics were measured. In 44 people with type 2 diabetes on metformin monotherapy (Hemoglobin A1c 7.4%, mGFR 113 mL/min), dapagliflozin versus gliclazide reduced mGFR by 5, 10, and 12 mL/min in the consecutive phases while both agents similarly improved Hemoglobin A1c (-0.48% vs -0.65%). Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations. Gliclazide did not consistently alter renal hemodynamic parameters. Thus, beyond glucose control, SGLT2i reduce mGFR and filtration fraction in type 2 diabetes. The fact that renal vascular resistance was not increased by dapagliflozin suggests that this is due to post-glomerular vasodilation rather than pre-glomerular vasoconstriction.",2020,"Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations.","['44 people with type 2 diabetes on', 'type 2 diabetes', 'young people with type 1 diabetes and glomerular hyperfiltration', 'treated patients with type 2 diabetes']","['dapagliflozin versus gliclazide', 'SGLT2 inhibitor dapagliflozin', 'metformin', 'Gliclazide', 'Sodium-glucose cotransporter 2 inhibitors (SGLT2i', 'dapagliflozin', 'metformin monotherapy', 'dapagliflozin with gliclazide', 'Dapagliflozin']","['renal hemodynamic effects', 'urinary adenosine and prostaglandin concentrations', 'renal hemodynamic parameters', 'Hemoglobin A1c', 'renal hemodynamics', 'mGFR and effective renal plasma flow', 'renal vascular resistance', 'glomerular filtration rate (mGFR', 'Filtration fraction and renal vascular resistance']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0206088', 'cui_str': 'ERPF'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",113.0,0.0276821,"Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations.","[{'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands. Electronic address: e.vanbommel@amsterdamumc.nl.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Michaël J B', 'Initials': 'MJB', 'LastName': 'van Baar', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Emanuel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bozovic', 'Affiliation': 'Department of Clinical Biochemistry, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Division of Pharmacology and Vascular Medicine, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Geurts', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Henrik E', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}]",Kidney international,['10.1016/j.kint.2019.09.013']
110,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


To assess the efficacy of combined 5FU and Avastin injections in the treatment of primary pterygium METHODS: Sixteen eyes with primary pterygium received intralesional 5 fluorouracil and Avastin (2.5-5 mg) injections every 2 weeks for a maximum of five injections. Fourteen eyes of 14 patients received five injections, one eye received three injections and one eye received two injections. All eyes were followed at monthly intervals for 3 months after last injection. Tissue was obtained by surgical excision of primary pterygium from four eyes who received injections and three eyes with primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I.
RESULTS


Pterygium progression was arrested in all patients. Sixty-two percent of patients had improvement of redness while 89% had reduced thickness of the lesion. VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
CONCLUSIONS


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
111,32329778,Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol.,"OBJECTIVE


The aim of this project is to study the effect of a physical therapist intervention provided in the first months of life on developmental outcomes of infants born very preterm. Secondary aims are to investigate the impact of intervention timing on the efficacy and impact of the intervention on infants with and without cerebral palsy.
METHODS


This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the Supporting Play, Exploration, and Early Development Intervention (SPEEDI)_Late or SPEEDI_Early group to a usual care group.
SETTINGS ARE URBAN


Urban and rural areas surrounding 2 academic medical centers. There will be 90 preterm infants enrolled in this study born at <29 weeks of gestation. SPEEDI is a developmental intervention provided by collaboration between a physical therapist and parent to support a child's motor and cognitive development. The primary outcome measure is the Bayley Scale of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores. Secondary measures include behavioral coding of early problem solving skills, the Gross Motor Function Measure, and Test of Infant Motor Performance.
IMPACT


More than 270,000 infants are born very preterm in the United States each year, 50% of whom will have neurological dysfunction that limits their ability to keep pace with peers who are typically developing. This study is a step toward understanding the impact that intensive developmental intervention could have in this population in the first months of life.",2020,"This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the SPEEDI_Late or SPEEDI_Early group to a usual care group.
","['Infants Born Very Preterm', 'infants with and without cerebral palsy', 'Urban and rural areas surrounding 2 academic medical centers', 'infants in the SPEEDI_Late or SPEEDI_Early group to a usual care group', '90 preterm infants enrolled in this study born at <\u200929\xa0weeks of gestation', 'infants born very preterm']","['intensive developmental intervention', 'Supporting Play Exploration and Early Development Intervention (SPEEDI', 'physical therapy intervention']","['behavioral coding of early problem solving skills, the Gross Motor Function Measure (GMFM), and Test of Infant Motor Performance (TIMP', 'Bayley Scale of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0501801,"This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the SPEEDI_Late or SPEEDI_Early group to a usual care group.
","[{'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, 1540 E Alcazar St, CHP 155, Los Angeles, CA 90033 (USA).'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Burnsed', 'Affiliation': 'Department of Pediatrics and Neurology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Shaaron E', 'Initials': 'SE', 'LastName': 'Brown', 'Affiliation': 'Board Certified Pediatric Specialist, Department of Physical Therapy, Virginia Commonwealth University Health, Richmond, Virginia.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Harper', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Hendricks-Munoz', 'Affiliation': 'Department of Pediatrics, Virginia Commonwealth University.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Stevenson', 'Affiliation': 'Division of Development & Behavioral Pediatrics, University of Virginia.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Molinini', 'Affiliation': 'Rehabilitation Movement Sciences Program and Motor Development Lab, Virginia Commonwealth University.'}]",Physical therapy,['10.1093/ptj/pzaa077']
112,32329780,High-Flow Oxygen Therapy During Exercise Training in Patients With Chronic Obstructive Pulmonary Disease and Chronic Hypoxemia: A Multicenter Randomized Controlled Trial.,"OBJECTIVE


The study aimed to evaluate whether high-flow oxygen therapy (HFOT) during training was more effective than oxygen in improving exercise capacity in hypoxemic chronic obstructive pulmonary disease (COPD).
METHODS


A total of 171 patients with COPD and chronic hypoxemia were consecutively recruited in 8 rehabilitation hospitals in a randomized controlled trial. Cycle-ergometer exercise training was used in 20 supervised sessions at iso inspiratory oxygen fraction in both groups. Pre- and post-training endurance time (Tlim), 6-minute walking distance (6MWD), respiratory and limb muscle strength, arterial blood gases, Barthel Index, Barthel Dyspnea Index, COPD Assessment Test, Maugeri Respiratory Failure questionnaire, and patient satisfaction were evaluated.
RESULTS


Due to 15.4% and 24.1% dropout rates, 71 and 66 patients were analyzed in HFOT and Venturi mask (V-mask) groups, respectively. Exercise capacity significantly improved after training in both groups with similar patient satisfaction. Between-group difference in post-training improvement in 6MWD (mean: 17.14 m; 95% CI = 0.87 to 33.43 m) but not in Tlim (mean: 141.85 seconds; 95% CI = -18.72 to 302.42 seconds) was significantly higher in HFOT. The minimal clinically important difference of Tlim was reached by 47% of patients in the V-mask group and 56% of patients in the HFOT group, whereas the minimal clinically important difference of 6MWD was reached by 51% of patients in the V-mask group and 69% of patients in the HFOT group, respectively.
CONCLUSION


In patients with hypoxemic COPD, exercise training is effective in improving exercise capacity.
IMPACT STATEMENT


The addition of HFOT during exercise training is not more effective than oxygen through V-mask in improving endurance time, the primary outcome, whereas it is more effective in improving walking distance.",2020,,['Patients With Chronic Obstructive Pulmonary Disease and Chronic Hypoxemia'],"['High-Flow Oxygen Therapy', 'Exercise Training']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",[],,0.296169,,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Vitacca', 'Affiliation': 'Respiratory Rehabilitation Department, Istituti Clinici Scientifici Maugeri IRCCS, Via Salvatore Maugeri, 4 - 27100 Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Paneroni', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Lumezzane, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Zampogna', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Tradate, Istituti Clinici Scientifici Maugeri IRCCS, Varese, Italy.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Visca', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Tradate, Istituti Clinici Scientifici Maugeri IRCCS, Varese, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Carlucci', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Pavia, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Cirio', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Pavia, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Banfi', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Milano, IRCCS Fondazione Don Gnocchi, Milano, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Pappacoda', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Milano, IRCCS Fondazione Don Gnocchi, Milano, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Trianni', 'Affiliation': 'Respiratory Rehabilitation of Villa Pineta, Pavullo nel Frignano, Modena, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Brogneri', 'Affiliation': 'Respiratory Rehabilitation of Villa Pineta, Pavullo nel Frignano, Modena, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Belli', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Veruno, Istituti Clinici Scientifici Maugeri IRCCS, Novara, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Paracchini', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Veruno, Istituti Clinici Scientifici Maugeri IRCCS, Novara, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Aliani', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Cassano delle Murge, Istituti Clinici Scientifici Maugeri IRCCS, Bari, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Spinelli', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Cassano delle Murge, Istituti Clinici Scientifici Maugeri IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Gigliotti', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Firenze, IRCCS Fondazione Don Gnocchi, Firenze, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lanini', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Firenze, IRCCS Fondazione Don Gnocchi, Firenze, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lazzeri', 'Affiliation': ""Ospedale Niguarda Ca' Granda, Milano, Italy.""}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Clini', 'Affiliation': 'Department of Medical and Surgical Sciences, Università degli Studi Modena e Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Malovini', 'Affiliation': 'Laboratory of Informatics and Systems Engineering for Clinical Research of the Institute of Pavia, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ambrosino', 'Affiliation': 'Respiratory Rehabilitation of the Institute of Montescano, Istituti Clinici Scientifici Maugeri IRCCS, Montescano, Pavia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Physical therapy,['10.1093/ptj/pzaa076']
113,32325012,"Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial.","BACKGROUND


Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections.
METHODS


In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual.
FINDINGS


Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ 2  test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
INTERPRETATION


The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery.
FUNDING


Fundación Asociación Española de Coloproctología.",2020,"No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
","['patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated', '13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention', 'Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated', 'Between May 2, 2015, and April 15, 2017', 'colon surgery (ORALEV', '582 patients for eligibility, of whom 565 were eligible']","['cefuroxime 1·5 g and metronidazole', 'metronidazole', 'ciprofloxacin', 'no oral antibiotics (n=282) or oral antibiotics', 'Preoperative oral antibiotics and surgical-site infections', 'oral antibiotics', 'oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group']","['risk of surgical-site infections', 'incidence of surgical-site infections', 'local complications, surgical complications, or medical complications', 'More complications (including surgical-site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0586901', 'cui_str': 'Colorectal surgeon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1510475', 'cui_str': 'Diverticula of intestine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0149750', 'cui_str': 'Partial resection of colon'}, {'cui': 'C0192871', 'cui_str': 'Total colectomy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",582.0,0.193492,"No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
","[{'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Espin Basany', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain. Electronic address: eespin@vhebron.net.""}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Solís-Peña', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pellino', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kreisler', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}, {'ForeName': 'Doménico', 'Initials': 'D', 'LastName': 'Fraccalvieri', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Muinelo-Lorenzo', 'Affiliation': 'Colorectal Surgery Unit, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Maseda-Díaz', 'Affiliation': 'Colorectal Surgery Unit, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'García-González', 'Affiliation': 'Coloproctology Surgery Unit, Department of General and Digestive Surgery, Cruces University Hospital, Barakaldo, Bzkaia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santamaría-Olabarrieta', 'Affiliation': 'Coloproctology Surgery Unit, Department of General and Digestive Surgery, Cruces University Hospital, Barakaldo, Bzkaia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Codina-Cazador', 'Affiliation': 'Colorectal Surgery Unit, Hosiptal Universitario Gerona, Universidad de Gerona, Girona, Spain.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Biondo', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30075-3']
114,32325037,"Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial.","BACKGROUND


The Middle East respiratory syndrome coronavirus (MERS-CoV) causes a respiratory disease with a case fatality rate of up to 35%. Given its potential to cause a public health emergency and the absence of efficacious drugs or vaccines, MERS is one of the WHO priority diseases warranting urgent research and development of countermeasures. We aimed to assess safety and tolerability of an anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine candidate that expresses the MERS-CoV spike glycoprotein, MVA-MERS-S, in healthy adults.
METHODS


This open-label, phase 1 trial was done at the University Medical Center Hamburg-Eppendorf (Hamburg, Germany). Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2  and weight of more than 50 kg at screening, and a negative pregnancy test for women. A key exclusion criterion was a previous MVA vaccination. For the prime immunisation, participants received doses of 1 × 10 7  plaque-forming unit (PFU; low-dose group) or 1 × 10 8  PFU (high-dose group) MVA-MERS-S intramuscularly. A second identical dose was administered intramuscularly as a booster immunisation 28 days after first injection. As a control group for immunogenicity analyses, blood samples were drawn at identical study timepoints from six healthy adults, who did not receive any injections. The primary objectives of the study were safety and tolerability of the two dosage levels and reactogenicity after administration. Immunogenicity was assessed as a secondary endpoint by ELISA and neutralisation tests. T-cell immunity was evaluated by interferon-γ-linked enzyme-linked immune absorbent spot assay. All participants who were vaccinated at least once were included in the safety analysis. Immunogenicity was analysed in the participants who completed 6 months of follow-up. This trial is registered with ClinicalTrials.gov, NCT03615911, and EudraCT, 2014-003195-23 FINDINGS: From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group) were enrolled and received the first dose of the vaccine according to their group allocation. Of these, 23 participants (12 in the low-dose group and 11 in the high-dose group) received a second dose of MVA-MERS-S according to their group allocation after a 28-day interval and completed follow-up. Homologous prime-boost immunisation with MVA-MERS-S revealed a benign safety profile with only transient mild-to-moderate reactogenicity. Participants had no severe or serious adverse events. 67 vaccine-related adverse events were reported in ten (71%) of 14 participants in the low-dose group, and 111 were reported in ten (83%) of 12 participants in the high-dose group. Solicited local reactions were the most common adverse events: pain was observed in 17 (65%; seven in the low-dose group vs ten in the high-dose group) participants, swelling in ten (38%; two vs eight) participants, and induration in ten (38%; one vs nine) participants. Headaches (observed in seven participants in the low-dose group vs nine in the high-dose group) and fatigue or malaise (ten vs seven participants) were the most common solicited systemic adverse events. All adverse events resolved swiftly (within 1-3 days) and without sequelae. Following booster immunisation, nine (75%) of 12 participants in the low-dose group and 11 (100%) participants in the high-dose group showed seroconversion using a MERS-CoV S1 ELISA at any timepoint during the study. Binding antibody titres correlated with MERS-CoV-specific neutralising antibodies (Spearman's correlation r=0·86 [95% CI 0·6960-0·9427], p=0·0001). MERS-CoV spike-specific T-cell responses were detected in ten (83%) of 12 immunised participants in the low-dose group and ten (91%) of 11 immunised participants in the high-dose group.
INTERPRETATION


Vaccination with MVA-MERS-S had a favourable safety profile without serious or severe adverse events. Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development.
FUNDING


German Center for Infection Research.",2020,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","['Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2  and weight of more than 50 kg at screening, and a negative pregnancy test for women', 'six healthy adults, who did not receive any injections', 'healthy adults', 'All participants who were vaccinated at least once were included in the safety analysis', 'Middle East respiratory syndrome', 'University Medical Center Hamburg-Eppendorf (Hamburg, Germany', ' From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group', '2014-003195-23', '23 participants (12 in the low-dose group and 11 in the high-dose group']","['1\u2008×\u200810 7  plaque-forming unit (PFU; low-dose group) or 1\u2008×\u200810 8  PFU (high-dose group) MVA-MERS-S intramuscularly', 'MVA-MERS-S', 'modified vaccinia virus Ankara vector vaccine candidate', 'anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine']","['adverse events', 'fatigue or malaise', 'Safety and immunogenicity', 'MERS-CoV spike-specific T-cell responses', 'safety and tolerability', 'Immunogenicity', 'severe or serious adverse events', 'seroconversion using a MERS-CoV S1 ELISA', 'Headaches', 'adverse events: pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042216', 'cui_str': 'Vaccinia virus'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",6.0,0.132455,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dahlke', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Krähling', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Nisreen M A', 'Initials': 'NMA', 'LastName': 'Okba', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eickmann', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Asisa', 'Initials': 'A', 'LastName': 'Volz', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesterkamp', 'Affiliation': 'German Center for Infection Research, Hanover-Brunswick, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Borregaard', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'My L', 'Initials': 'ML', 'LastName': 'Ly', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Zinser', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bartels', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Joseph S H', 'Initials': 'JSH', 'LastName': 'Poetsch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Neumann', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fux', 'Affiliation': 'Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmiedel', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Haagmans', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Sutter', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Marylyn M', 'Initials': 'MM', 'LastName': 'Addo', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany. Electronic address: m.addo@uke.de.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30248-6']
115,32327254,Application of Automated Quantification of Fluid Volumes to Anti-VEGF Therapy of Neovascular Age-Related Macular Degeneration.,"PURPOSE


Anti-vascular endothelial growth factor (VEGF) treatment of neovascular age-related macular degeneration (AMD) is a highly effective advance in the retinal armentarium. OCT offering 3-dimensional imaging of the retina is widely used to guide treatment. Although poor outcomes reported from clinical practice are multifactorial, availability of reliable, reproducible, and quantitative evaluation tools to accurately measure the fluid response, that is, a ""VEGF meter,"" may be a better means of monitoring and treating than the current purely qualitative evaluation used in clinical practice.
DESIGN


Post hoc analysis of a phase III, randomized, multicenter study.
PARTICIPANTS


Study eyes of 1095 treatment-naive subjects receiving pro re nata (PRN) or monthly ranibizumab therapy according to protocol-specified criteria in the HARBOR study.
METHODS


A deep learning method for localization and quantification of fluid in all retinal compartments was applied for automated segmentation of fluid with every voxel classified by a convolutional neural network (CNN). Three-dimensional volumes (nanoliters) for intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelial detachment (PED) were determined in 24 362 volume scans obtained from 1095 patients treated over 24 months in a phase III clinical trial with randomization to 2 drug dosages (0.5 mg and 2.0 mg ranibizumab) and 2 regimens (monthly and PRN). A multivariable mixed-effects regression model was used to test for differences in fluid between the arms and for fluid/function correlation.
MAIN OUTCOME MEASURES


Fluid volume in nanoliters, structure-function as Pearson's correlation coefficient, and as a coefficient of determination (R 2 ).
RESULTS


Fluid volumes were quantified in all visits of all patients. Automated segmentation demonstrated characteristic response patterns for each fluid compartment individually: Intraretinal fluid showed the greatest and most rapid resolution, followed by SRF and PED the least. The loading dose treatment achieved resolution of all fluid types close to the lowest levels attainable. Dosage and regimen parameters correlated directly with resulting fluid volumes. Fluid/function correlation showed a volume-dependent negative impact of IRF on vision and weak positive prognostic effect of SRF.
CONCLUSIONS


Automated quantification of the fluid response may improve therapeutic management of neovascular AMD, avoid discrepancies between clinicians/investigators, and establish structure/function correlations.",2020,"Automated segmentation demonstrated characteristic response patterns for each fluid compartment individually: Intraretinal fluid showed the greatest and most rapid resolution, followed by SRF and PED the least.","['Study eyes of 1095 treatment-naive subjects receiving pro re nata (PRN) or monthly ranibizumab therapy according to protocol-specified criteria in the HARBOR study', 'neovascular age-related macular degeneration (AMD', 'Neovascular Age-Related Macular Degeneration']","['Anti-vascular endothelial growth factor (VEGF', 'ranibizumab']","[""Fluid volume in nanoliters, structure-function as Pearson's correlation coefficient, and as a coefficient of determination (R 2 "", 'intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelial detachment (PED']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0560008', 'cui_str': 'nL'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}]",,0.0677886,"Automated segmentation demonstrated characteristic response patterns for each fluid compartment individually: Intraretinal fluid showed the greatest and most rapid resolution, followed by SRF and PED the least.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria. Electronic address: ursula.schmidt-erfurth@meduniwien.ac.at.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Vogl', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lee Merrill', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Bogunović', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.010']
116,32279360,Effect of resistance training on quality of life in older people with sarcopenic obesity living in long-term care institutions: A quasi-experimental study.,"AIMS AND OBJECTIVES


To measure the effect of chair resistance training (RT) on the quality of life (QoL) of older long-term care residents with sarcopenic obesity (SO).
BACKGROUND


Sarcopenia combined with obesity, commonly called SO, is considered to be related to health-related QoL. Despite concerns regarding SO-related long-term healthcare issues, intervention studies on SO residents in nursing homes are scant in Taiwan.
DESIGN


This research was a quasi-experiment conducted according to the TREND Checklist. A total of 123 older persons were enrolled from six nursing facilities. The RT was implemented between October 2015-March 2016.
METHOD


The intervention group received progressive RT with sandbags/dumbbells twice a week for 3 months, whereas the comparison group received the usual care. QoL was the major outcome variable. Data were analysed using chi-square test, Student's t test and generalised estimating equation (GEE).
RESULTS


The various definition criteria for SO can influence the results of QoL in the older persons. From the body composition perspective, in the GEE analysis, the SO cut-off points for neither skeletal muscle mass percentage (SMMp) nor appendicular skeletal muscle mass index demonstrated significant between-group differences in the QoL variable after the 3-month RT intervention. Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value < .05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity). RT was one of the protective factors.
CONCLUSION


In the SO group, the effect of muscle strength on QoL is greater than the effect of changes in body composition after RT.
RELEVANCE TO CLINICAL PRACTICE


This study analysed the influence of RT on QoL in subjects with different categories of SO. RT is one of the ways to promote QoL among the SO population. ClinicalTrials.gov Identifier: NCT02912338.",2020,"Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value <0.05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity).","['123 older persons were enrolled from six nursing facilities', 'older people with sarcopenic obesity living in long-term care institutions', 'subjects with different categories of SO', 'elderly long-term care residents with sarcopenic obesity (SO', 'older persons']","['progressive RT with sandbags/dumbbells twice a week for 3 months, whereas the comparison group received the usual care', 'resistance training', 'chair resistance training (RT']","['quality of life (QoL', 'time on anxiety/depression', 'quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179847', 'cui_str': 'Chair'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",123.0,0.0452616,"Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value <0.05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity).","[{'ForeName': 'Shu-Fang', 'Initials': 'SF', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shu-Ching', 'Initials': 'SC', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing & Health Sciences, Taipei, Taiwan, ROC.'}]",Journal of clinical nursing,['10.1111/jocn.15277']
117,32322880,Neural correlates of cognitive bias modification for interpretation.,"The effectiveness of cognitive bias modification for interpretation (CBM-I), a treatment method employed to reduce social anxiety (SA), has been examined. However, the neural correlates of CBM-I remain unclear, and we aimed to elucidate brain activities during intervention and activity changes associated with CBM-I effectiveness in a pre-post intervention comparison. Healthy participants divided into two groups (CBM, control) were scanned before, during and after intervention using functional magnetic resonance imaging. Ambiguous social situations followed by positive outcomes were repeatedly imagined by the CBM group during intervention, while half of the outcomes in the control group were negative. Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group. Furthermore, altered activities in the somatomotor and somatosensory areas, occipital lobe and posterior cingulate gyrus during interpreting ambiguous social situations showed a significant group × change in SA interaction. Our result suggests that when facing ambiguous social situations, positive imagery instilled by CBM-I is recalled, and interpretations are modified to contain social reward. These findings may help to suggest an alternative manner of enhancing CBM-I effectiveness from a cognitive-neuroscience perspective.",2020,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.",['Healthy participants'],[],"['social anxiety (SA', 'activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0458361', 'cui_str': 'Somesthetic area'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0228243', 'cui_str': 'Structure of lateral occipitotemporal gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0220369,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sakaki', 'Affiliation': 'Department of Functional Brain Imaging, Graduate School of Medicine, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Nozawa', 'Affiliation': 'Research Institute for the Earth Inclusive Sensing Empathizing with Silent Voices, Tokyo Institute of Technology, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa026']
118,32243907,Transcranial Direct Current Stimulation of Supplementary Motor Region Impacts the Effectiveness of Interleaved and Repetitive Practice Schedules for Retention of Motor Skills.,"Interleaved rather than repetitive practice (RP) is associated with superior retention of motor skills. It has been argued that this results from improved post-practice consolidation reflected in greater offline gains following interleaved practice (IP). The magnitude of this offline benefit has been associated with greater recruitment of supplementary motor area (SMA) during encoding. The present study administered anodal or cathodal transcranial direct current stimulation (tDCS) during interleaved or RP respectively in an attempt to modify the activity at SMA and the concomitant retention outcomes commonly associated with these training formats. Sixty-nine participants were assigned to one of four experimental conditions that included: IP-sham, RP-sham, IP-cathodal tDCS, and RP-anodal tDCS. Real or sham stimulation at SMA was administered during practice of three unique 6-key discrete sequence production tasks which lasted approximately 20-min. Tests were administered prior to practice and immediately after practice as well at 6-h, 24-h, and 72-h after practice ended. As anticipated, IP resulted in poorer acquisition but superior offline gain. Enhanced offline gain following interleaved training resulted from rapid stabilization of performance within the first 6-h following encoding and overnight improvement that continued over multiple sleep episodes. Administration of anodal stimulation at SMA during RP improved performance during training compared to sham but this benefit was short lived as forgetting during the first 6-h after practice was consistent with that observed for the sham counterpart. However, supplementing RP with anodal stimulation at SMA did foster overnight offline performance gains not displayed by individuals that experienced RP in the absence of stimulation.",2020,Administration of anodal stimulation at SMA during repetitive practice improved performance during training compared to sham but this benefit was short lived as forgetting during the first 6-hr after practice was consistent with that observed for the sham counterpart.,['Sixty-nine participants were assigned to one of four experimental conditions that included'],"['interleaved training', 'interleaved practice-sham, repetitive practice-sham, interleaved practice-cathodal tDCS, and repetitive practice-anodal tDCS']",[],"[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],69.0,0.107243,Administration of anodal stimulation at SMA during repetitive practice improved performance during training compared to sham but this benefit was short lived as forgetting during the first 6-hr after practice was consistent with that observed for the sham counterpart.,"[{'ForeName': 'Taewon', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Non-invasive Brain Stimulation Laboratory, Department of Kinesiology, Texas A&M University, College Station, TX 77843-4243, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Wright', 'Affiliation': 'Non-invasive Brain Stimulation Laboratory, Department of Kinesiology, Texas A&M University, College Station, TX 77843-4243, United States. Electronic address: davidwright@tamu.edu.'}]",Neuroscience,['10.1016/j.neuroscience.2020.03.043']
119,32298704,Pain-modulating effects of oxytocin in patients with chronic low back pain.,"The neuropeptide oxytocin (OT) has been shown to play a modulatory role in nociception. However, analgesic effects of OT in chronic pain conditions remain elusive and the neural underpinnings have not yet been investigated in humans. Here, we conducted an exploratory, randomized, placebo-controlled, cross-over study to examine effects of intranasal OT in male patients suffering from chronic low back pain (CBP) versus healthy controls (HC). N = 22 participants with CBP and 22 HCs were scanned using functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back. During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs. Spontaneously experienced pain in contrast to heat pain was associated with activation changes in the medial frontal cortex (MFC) and the anterior cingulate cortex (ACC) as reported in previous studies. However, we did not observe OT effects on spontaneously experienced pain in CBP patients. Overall, our preliminary data may suggest that the striatum is a key structure underlying the pain-modulating effects of OT in patients with chronic pain and adds to the growing evidence linking the neuropeptide to pain modulation in humans. Further studies on neuronal OT effects in larger samples of chronic back pain patients are needed to understand probable mechanisms of OT effects in chronic pain. This article is part of the special issue on Neuropeptides.",2020,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"['N\u202f=\u202f22 participants with CBP and 22\u202fHCs', 'male patients suffering from chronic low back pain (CBP) versus healthy controls (HC', 'patients with chronic low back pain', 'chronic back pain patients', 'patients with chronic pain']","['neuropeptide oxytocin (OT', 'OT', 'OT versus PL', 'intranasal OT', 'placebo', 'functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back', 'oxytocin']","['BOLD responses', 'pain intensity ratings', 'medial frontal cortex (MFC) and the anterior cingulate cortex (ACC', 'OT effects']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004600', 'cui_str': 'Back'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",22.0,0.105867,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boll', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ueltzhoeffer', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Roth', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany; Department of Psychology and Psychotherapy, Ludwigs-Maximilian-University München, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Nees', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Grinevich', 'Affiliation': 'Department of Neuropeptide Research in Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Herpertz', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany. Electronic address: Sabine.Herpertz@med.uni-heidelberg.de.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108105']
120,31451704,"Rice bran extract supplement improves sleep efficiency and sleep onset in adults with sleep disturbance: A randomized, double-blind, placebo-controlled, polysomnographic study.","We previously reported that rice bran extract supplement (RBS) administration to mice decreased sleep latency and induced non-rapid eye movement (NREM) sleep via inhibition of the histamine H 1  receptor. Based on this, we performed the first clinical trial to investigate whether RBS would be beneficial to subjects with disturbed sleep. We performed a randomized, double-blinded, placebo-controlled, 2-week study. Fifty subjects with sleep disturbance were enrolled and received either RBS (1,000 mg/day) or placebo. Polysomnography was performed, and Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale were administered at the initiation and termination of the study. Compared with the placebo, RBS led to significant polysomnographic changes, including decreased sleep latency (adjusted, P = 0.047), increased total sleep time (P = 0.019), and improved sleep efficiency (P = 0.010). Additionally, the amount of stage 2 sleep significantly increased in the RBS group. When adjusted for caffeine intake, wakefulness after sleep onset, total wake time, and delta activity tended to decrease in the RBS group. RBS administration decreased ESS scores. There were no reported serious adverse events in both groups. RBS improved sleep in adults with sleep disturbance. Trial registration: WHO ICTRP, KCT0001893.",2019,There were no reported serious adverse events in both groups.,"['subjects with disturbed sleep', 'adults with sleep disturbance', 'Fifty subjects with sleep disturbance']","['placebo', 'RBS', 'Rice bran extract supplement', 'placebo, RBS', 'rice bran extract supplement (RBS']","['serious adverse events', 'RBS improved sleep', 'sleep efficiency and sleep onset', 'sleep latency and induced non-rapid eye movement (NREM) sleep via inhibition', 'Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale', 'ESS scores', 'total sleep time', 'sleep efficiency', 'sleep latency', 'amount of stage 2 sleep', 'caffeine intake, wakefulness after sleep onset, total wake time, and delta activity']","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3810876', 'cui_str': 'Rice bran'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",50.0,0.3013,There were no reported serious adverse events in both groups.,"[{'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Um', 'Affiliation': 'Research division of functional food functionality, Korea Food Research Institute, Wanju, 55365, Republic of Korea.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Research division of functional food functionality, Korea Food Research Institute, Wanju, 55365, Republic of Korea.'}, {'ForeName': 'Jin Kyu', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Seoul Sleep Center, Seoul, 06041, Republic of Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Seoul National University, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Seung Wan', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Seoul National University, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Minseok', 'Initials': 'M', 'LastName': 'Yoon', 'Affiliation': 'Research division of functional food functionality, Korea Food Research Institute, Wanju, 55365, Republic of Korea.'}, {'ForeName': 'Sangoh', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'S&D Research and Development Institute, Cheongju, 28156, Republic of Korea.'}, {'ForeName': 'Suengmok', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Food Science and Technology, Pukyong National University, Busan, 48513, Republic of Korea. scho@pknu.ac.kr.'}]",Scientific reports,['10.1038/s41598-019-48743-8']
121,30996338,"Visual Function Questionnaire as an outcome measure for homonymous hemianopia: subscales and supplementary questions, analysis from the VISION trial.","BACKGROUND


We conduct supplementary analyses of the NEI VFQ-25 data to evaluate where changes occurred within subscales of the NEI VFQ-25 leading to change in the composite scores between the three treatment arms, and evaluate the NEI VFQ-25 with and without the Neuro 10 supplement.
METHODS


A prospective, multicentre, parallel, single-blind, three-arm RCT of fourteen UK acute stroke units was conducted. Stroke survivors with homonymous hemianopia were recruited. Interventions included: Fresnel prisms for minimum 2 h, 5 days/week over 6-weeks (Arm a), Visual search training for minimum 30 min, 5 days/week over 6-weeks (Arm b) and standard care-information only (Arm c). Primary and secondary outcomes (including NEI VFQ-25 data) were measured at baseline, 6, 12 and 26 weeks after randomisation.
RESULTS


Eighty seven patients were recruited (69% male; mean age (SD) equal to 69 (12) years). At 26 weeks, outcomes for 24, 24 and 22 patients, respectively, were compared to baseline. NEI VFQ-25 (with and without Neuro 10) responses improved from baseline to 26 weeks with visual search training compared to Fresnel prisms and standard care. In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'.
CONCLUSIONS


Composite scores differed systematically for the NEI VFQ-25 (Neuro 10) versus NEI VFQ-25 at all time points. For subscale scores, descriptive statistics suggest clinically relevant improvement in distance activities and vision-specific dependency subscales for NEI VFQ-25 scores in the visual search treatment arm.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN05956042.",2019,"In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'.
","['Stroke survivors with homonymous hemianopia', 'fourteen UK acute stroke units', 'seven patients were recruited (69% male; mean age (SD) equal to 69 (12) years', 'Eighty']","['visual search training', 'Visual search training', 'NEI VFQ-25']","[""colour vision' and 'ocular pain"", 'Visual Function Questionnaire', 'distance activities and vision-specific dependency subscales for NEI VFQ-25 scores', 'NEI VFQ-25 data']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0271202', 'cui_str': 'Hemianopsia, Homonymous'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}]","[{'cui': 'C0086032', 'cui_str': 'Daylight Vision'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",87.0,0.249442,"In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'.
","[{'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Rowe', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Liverpool, L69 3GB, UK. rowef@liverpool.ac.uk.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Hepworth', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Conroy', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Naomi E A', 'Initials': 'NEA', 'LastName': 'Rainford', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bedson', 'Affiliation': 'Clinical Trials Research Unit, University of Liverpool, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Howard', 'Affiliation': 'Department of Orthoptics, Salford Royal NHS Foundation Trust, Manchester, M6 8HD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pollock', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Shipman', 'Affiliation': 'Department of Orthoptics, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dodridge', 'Affiliation': 'Department of Orthoptics, Oxford University Hospitals NHS Trust, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Stevie', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Eye Clinic Support Service, Royal National Institute of Blind People, Birmingham, B29 6NA, UK.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Noonan', 'Affiliation': 'Department of Ophthalmology, Aintree University Hospital NHS Foundation Trust, Liverpool, L9 7AL, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sackley', 'Affiliation': ""Division of Health and Social Care, King's College, London, WC2B 5RL, UK.""}]","Eye (London, England)",['10.1038/s41433-019-0441-z']
122,31504090,Acute Effect of Eating Sweets on Alcohol Cravings in a Sample with At-Risk Drinking.,"BACKGROUND


Alcohol craving, or the desire to drink alcohol, has been identified as a key experience preceding alcohol use. Alcoholics Anonymous has long claimed that individuals can allay alcohol cravings by eating sweets. Empirical tests of this strategy are limited to a few preclinical studies in rats, and there is no existing experiment testing the acute effect of eating sweets on alcohol cravings in humans.
PURPOSE


The current study sought to experimentally test the acute effect of eating sweets on alcohol cravings in a sample with at-risk drinking.
METHODS


After being exposed to an alcohol cue, individuals with at-risk drinking (N = 150) were randomly assigned to eat sweets (n = 60), eat calorie-equivalent bland food (n = 60), or watch a video (n = 30). Caloric amounts were manipulated. Individuals with at-risk drinking were then exposed to a second alcohol cue. Changes in alcohol cravings from after the first to after the second alcohol cue were measured via visual analog scale and heart rate.
RESULTS


There were no significant between-group differences in changes in alcohol cravings. Caloric amounts did not modify effects.
CONCLUSIONS


Experimental findings did not provide evidence to support the clinical lore that eating sweets can reduce alcohol cravings, albeit only acutely and for those with at-risk drinking. Other empirically supported strategies for managing alcohol cravings (e.g., pharmacotherapies, mindfulness) could instead be promoted.",2020,There were no significant between-group differences in changes in alcohol cravings.,"['individuals with at-risk drinking (N = 150', 'a Sample with At-Risk Drinking', 'Individuals with at-risk drinking']","['Eating Sweets', 'eat calorie-equivalent bland food', 'eating sweets', 'eat sweets']","['alcohol cravings', 'visual analog scale and heart rate', 'Alcohol Cravings']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0125672,There were no significant between-group differences in changes in alcohol cravings.,"[{'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Cummings', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nooteboom', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz031']
123,32327255,Visual Field Outcomes in the Tube Versus Trabeculectomy Study.,"PURPOSE


To describe visual field (VF) outcomes in the Tube Versus Trabeculectomy (TVT) Study.
DESIGN


Cohort analysis of patients in a multicenter randomized clinical trial.
PARTICIPANTS


A total of 122 eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups.
METHODS


The TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery (350-mm 2  Baerveldt implant) and trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 4 minutes) in patients with previous cataract or glaucoma surgery. Enrolled patients underwent perimetry at baseline and annual follow-up visits. The VFs were included if the false-positive rate was ≤20% and false-negative rate was ≤35%. The VFs were excluded if visual acuity <20/400 or loss of ≥2 Snellen lines from baseline was attributed to an etiology other than glaucoma. Longitudinal linear mixed-effects models with best linear unbiased predictions (BLUPs) were applied to estimate rates of change in mean deviation (MD) for each treatment group.
MAIN OUTCOME MEASURE


Rate of MD change during follow-up period.
RESULTS


A total of 436 reliable VFs were analyzed, with an average of 3.6 VFs per eye. Baseline MD was -13.07 ± 8.4 decibels (dB) in the tube shunt group and -13.18 ± 8.2 dB in the trabeculectomy group (P = 0.99). The rate of change in MD was -0.60 dB/year in the tube group and -0.38 dB/year in the trabeculectomy group (P = 0.34). The 95% confidence intervals for the rates of MD change were -0.77 to -0.44 dB/year in the tube group and -0.56 to -0.20 dB/year in the trabeculectomy group. No significant difference in MD slope was seen when patients were categorized by percentage of visits with intraocular pressure (IOP) <18 mmHg or by average IOP. Univariable and multivariable risk factor analyses identified history of diabetes, elevated IOP, and worse MD as baseline factors associated with more rapid VF loss.
CONCLUSIONS


Slow rates of VF loss were observed after randomized surgical treatment in the TVT Study, but no significant difference in the rate of VF loss was seen after tube shunt implantation and trabeculectomy with MMC. Patients with diabetes, higher IOP, and more severe VF loss at baseline were at higher risk for VF progression.",2020,The rate of change in MD was -0.60 dB/year in the tube group and -0.38,"['A total of 122 eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups', 'Enrolled patients underwent perimetry at baseline and annual follow-up visits', 'patients with previous cataract or glaucoma surgery']","['Tube Versus Trabeculectomy (TVT', 'tube shunt surgery (350-mm 2  Baerveldt implant) and trabeculectomy with mitomycin C (MMC']","['Rate of MD change during follow-up period', 'false-positive rate', 'rate of change in MD', 'Baseline MD', 'VF loss', 'rate of VF loss', 'rates of MD change', 'Visual Field Outcomes', 'severe VF loss', 'MD slope']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031061', 'cui_str': 'Perimetry'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0600545', 'cui_str': 'Baerveldt Implants'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",436.0,0.137452,The rate of change in MD was -0.60 dB/year in the tube group and -0.38,"[{'ForeName': 'Swarup S', 'Initials': 'SS', 'LastName': 'Swaminathan', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Alessandro A', 'Initials': 'AA', 'LastName': 'Jammal', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Kornmann', 'Affiliation': 'Glaucoma Associates of Texas, Dallas, Texas.'}, {'ForeName': 'Philip P', 'Initials': 'PP', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, University of Washington, Seattle, Washington.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Medeiros', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: sgedde@med.miami.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.02.034']
124,32281113,Comparison of proximal and distal corticosteroid injections for carpal tunnel syndrome.,"INTRODUCTION


Evidence for the efficacy of distal corticosteroid injection compared with proximal injection in carpal tunnel syndrome (CTS) is inadequate.
METHODS


We conducted a randomized, double-blind noninferiority trial of 131 wrists with CTS. Forty milligrams of methylprednisolone was injected medial to the palmaris longus tendon 2 cm proximal to the wrist crease, or at the volar aspect, 2 to 3 cm distal to the wrist crease. Proximal & distal groups received a placebo. The primary outcome was difference in CTS Symptom Severity Scale (SSS) score at 1 month. Secondary outcome measures included the difference in SSS score at 3 months, Functional Status Scale (FSS) score at 1 and 3 months, and pain of injections.
RESULTS


No significant differences were noted between groups in scores on the SSS and FSS. Pain was lower in the proximal group compared with the distal group.
DISCUSSION


Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, yet they are more painful.",2020,"Pain was lower in the proximal than distal group Discussion Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, but are more painful.","['131 wrists with CTS', 'carpal tunnel syndrome']","['methylprednisolone', 'placebo', 'proximal and distal corticosteroid injections', 'proximal injection', 'distal corticosteroid injection']","['CTS symptom severity scale (SSS', 'difference in SSS at 3 months, functional status scale (FSS', 'Pain', 'pain of injections']","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",131.0,0.175168,"Pain was lower in the proximal than distal group Discussion Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, but are more painful.","[{'ForeName': 'Pradeep Pankajakshan', 'Initials': 'PP', 'LastName': 'Nair', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Wadwekar', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sunitha Vellathussery', 'Initials': 'SV', 'LastName': 'Chakkalakkoombil', 'Affiliation': 'Department of Radiodiagnosis, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Narayan', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Revanth', 'Initials': 'R', 'LastName': 'Marusani', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Murgai', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sibi', 'Initials': 'S', 'LastName': 'Thirunavukkarasu', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Amritha', 'Initials': 'A', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Harichandrakumar Kottyen', 'Initials': 'HK', 'LastName': 'Thazhath', 'Affiliation': 'Department of Medical Biometrics and Informatics, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}]",Muscle & nerve,['10.1002/mus.26886']
125,31860405,Impact of Conditioning Intensity of Allogeneic Transplantation for Acute Myeloid Leukemia With Genomic Evidence of Residual Disease.,"PURPOSE


Patients with acute myeloid leukemia (AML) in remission remain at risk for relapse even after allogeneic hematopoietic cell transplantation (alloHCT). AML measurable residual disease (MRD) status before alloHCT has been shown to be prognostic. Whether modulation of the intensity of the alloHCT conditioning regimen in patients with AML who test positive for MRD can prevent relapse and improve survival is unknown.
METHODS


Ultra-deep, error-corrected sequencing for 13 commonly mutated genes in AML was performed on preconditioning blood from patients treated in a phase III clinical trial that randomly assigned adult patients with myeloid malignancy in morphologic complete remission to myeloablative conditioning (MAC) or reduced-intensity conditioning (RIC).
RESULTS


No mutations were detected in 32% of MAC and 37% of RIC recipients; these groups had similar survival (3-year overall survival [OS], 56%  v  63%;  P  = .96). In patients with a detectable mutation (next-generation sequencing [NGS] positive), relapse (3-year cumulative incidence, 19%  v  67%;  P  < .001) and survival (3-year OS, 61%  v  43%;  P  = .02) was significantly different between the MAC and RIC arms, respectively. In multivariable analysis for NGS-positive patients, adjusting for disease risk and donor group, RIC was significantly associated with increased relapse (hazard ratio [HR], 6.38; 95% CI, 3.37 to 12.10;  P  < .001), decreased relapse-free survival (HR, 2.94; 95% CI, 1.84 to 4.69;  P  < .001), and decreased OS (HR, 1.97; 95% CI, 1.17 to 3.30;  P  = .01) compared with MAC. Models of AML MRD also showed benefit for MAC over RIC for those who tested positive.
CONCLUSION


This study provides evidence that MAC rather than RIC in patients with AML with genomic evidence of MRD before alloHCT can result in improved survival.",2020,"No mutations were detected in 32% of MAC and 37% of RIC recipients; these groups had similar survival (3-year overall survival [OS], 56%  v  63%;  P  = .96).","['patients with AML who test positive for MRD', 'Patients with acute myeloid leukemia (AML) in remission remain at risk for relapse even after allogeneic hematopoietic cell transplantation (alloHCT', 'Acute Myeloid Leukemia With Genomic Evidence of Residual Disease', 'patients with AML']","['myeloablative conditioning (MAC) or reduced-intensity conditioning (RIC', 'Allogeneic Transplantation']","['similar survival (3-year overall survival [OS', 'survival', 'relapse-free survival', 'AML measurable residual disease (MRD) status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0153886', 'cui_str': 'Acute myeloid leukemia in remission (disorder)'}, {'cui': 'C1320679', 'cui_str': 'At risk for relapse'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic Grafting'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.413975,"No mutations were detected in 32% of MAC and 37% of RIC recipients; these groups had similar survival (3-year overall survival [OS], 56%  v  63%;  P  = .96).","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Hourigan', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'Dillon', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Gege', 'Initials': 'G', 'LastName': 'Gui', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Fei', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Ghannam', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Yuesheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Licon', 'Affiliation': 'ArcherDX, Boulder, CO.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Alyea', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Bashey', 'Affiliation': 'Blood and Marrow Transplant Program at Northside Hospital, Atlanta, GA.'}, {'ForeName': 'H Joachim', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': 'National Marrow Donor Program and Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Hugo F', 'Initials': 'HF', 'LastName': 'Fernandez', 'Affiliation': 'Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': 'West Virginia University Medicine, Morgantown, WV.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'National Marrow Donor Program and Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Porter', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Scott', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Warlick', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Horwitz', 'Affiliation': 'Duke University, Durham, NC.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03011']
126,30940887,The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.,"PURPOSE


In this study we compared the anatomic and functional outcomes of two steroid treatments on rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD), namely treatment with oral prednisolone (1 mg/kg daily) for 3-7 days before vitrectomy or a single periocular injection of methylprednisolone (40 mg) 1-3 days before vitrectomy. We also analyzed the outcomes of the eyes with subsided CD and the eyes with persistent CD that underwent drainage of suprachoroidal fluids during the vitrectomy.
METHODS


This was a prospective randomized study. Seventy five eyes with RRD combined with CD were divided into 2 groups based on the two different treatment regimens as above. The eyes in each group were further divided into 2 subgroups (A: CD subsided eyes; B: CD persistent eyes) according to the response of CD to the treatment of steroids. Retinal reattachment rates were measured at 6 months after the removal of silicone oil.
RESULTS


At 6 months after silicone oil removal, the retinal reattachment rate was similar (p = 0.666) in the oral prednisolone group (91.7%, 33/36) and the periocular injection group (94.9%, 37/39). Similar retinal reattachment rates (p = 0.364) were also found in the CD subsided eyes (97.1%, 34/35) and the CD persistent eyes (90.0%, 36/40). The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25).
CONCLUSIONS


For RRD combined with CD, eyes treated with a single periocular injection of methylprednisolone (40 mg, 1-3 days before pars plana vitrectomy) combined with the drainage of suprachoroidal fluids during the surgery had similar anatomic and functional outcomes compared to the eyes treated with oral prednisolone for 3-7 days before vitrectomy.",2019,"The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25).
","['rhegmatogenous retinal detachment combined with choroidal detachment', 'Seventy five eyes with RRD combined with CD']","['methylprednisolone and drainage of suprachoroidal fluid', 'oral prednisolone', 'methylprednisolone', 'rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD', 'steroid treatments', 'silicone oil', 'prednisolone']","['retinal reattachment rate', 'Retinal reattachment rates', 'Similar retinal reattachment rates']","[{'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0395611', 'cui_str': 'Drainage of suprachoroidal fluid (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0185042', 'cui_str': 'Refixation (procedure)'}]",75.0,0.0482548,"The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25).
","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325027, China. weiyongdoctor@163.com.'}, {'ForeName': 'RongLe', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ""Shaanxi Ophthalmic Medical Center, Xi'an No.4 Hospital, Affiliated Guangren Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an, 710004, China.""}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Xiamen Eye Center Affiliated to Xiamen University, Xiamen, 361000, China.'}, {'ForeName': 'Xiuju', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Xiamen Eye Center Affiliated to Xiamen University, Xiamen, 361000, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325027, China.'}]","Eye (London, England)",['10.1038/s41433-019-0420-4']
127,31634401,Single Session Transcranial Magnetic Stimulation Ameliorates Hand Gesture Deficits in Schizophrenia.,"Social interaction is impaired in schizophrenia, including the use of hand gestures, which is linked to poor social perception and outcome. Brain imaging suggests reduced neural activity in a left-lateralized frontoparietal network during gesture preparation; therefore, gesturing might be improved through facilitation of left hemispheric brain areas or via disruption of interhemispheric inhibition from the right homolog. This study tested whether repetitive transcranial magnetic stimulation (rTMS) protocols would improve gesture performance in schizophrenia. This randomized, placebo-controlled, double-blind, crossover trial applied 3 different protocols of rTMS separated by 48 h. Twenty right-handed schizophrenia patients and 20 matched healthy controls received facilitatory intermittent theta burst stimulation (iTBS) over the left inferior frontal gyrus (IFG), inhibitory continuous theta burst stimulation (cTBS) over right inferior parietal lobe (IPL), and placebo over left IPL in randomized order. Primary outcome was change in the test of upper limb apraxia (TULIA), rated from video recordings of hand gesture performance. Secondary outcome was change in manual dexterity using the coin rotation task. Participants improved on both tasks following rTMS compared with baseline. Only patients improved gesture performance following right IPL cTBS compared with placebo (P = .013). The results of the coin rotation parallel those of the TULIA, with improvements following right IPL cTBS in patients (P = .001). Single sessions of cTBS on the right IPL substantially improved both gesture performance accuracy and manual dexterity. The findings point toward an inhibition of interhemispheric rivalry as a potential mechanism of action.",2020,"Social interaction is impaired in schizophrenia, including the use of hand gestures, which is linked to poor social perception and outcome.","['separated by 48 h. Twenty right-handed schizophrenia patients and 20 matched healthy controls received', 'schizophrenia', 'Schizophrenia']","['Single Session Transcranial Magnetic Stimulation', 'repetitive transcranial magnetic stimulation (rTMS) protocols', 'placebo', 'rTMS', 'facilitatory intermittent theta burst stimulation (iTBS) over the left inferior frontal gyrus (IFG), inhibitory continuous theta burst stimulation (cTBS) over right inferior parietal lobe (IPL), and placebo']","['change in the test of upper limb apraxia (TULIA), rated from video recordings of hand gesture performance', 'gesture performance accuracy and manual dexterity', 'neural activity', 'manual dexterity using the coin rotation task', 'gesture performance']","[{'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0003635', 'cui_str': 'Dyspraxia'}, {'cui': 'C0042650', 'cui_str': 'Audiovisual Recording'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0524669', 'cui_str': 'Coins'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",20.0,0.247918,"Social interaction is impaired in schizophrenia, including the use of hand gestures, which is linked to poor social perception and outcome.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Walther', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Kunz', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Zürcher', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Vladimirova', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Hanta', 'Initials': 'H', 'LastName': 'Bachofner', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Konstantin A', 'Initials': 'KA', 'LastName': 'Scherer', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Niluja', 'Initials': 'N', 'LastName': 'Nadesalingam', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Stegmayer', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bohlhalter', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Petra V', 'Initials': 'PV', 'LastName': 'Viher', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Switzerland.'}]",Schizophrenia bulletin,['10.1093/schbul/sbz078']
128,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND


No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2.
METHODS


We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first.
RESULTS


A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events.
CONCLUSIONS


In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282']
129,32159228,Alcoholics Anonymous and other 12-step programs for alcohol use disorder.,"BACKGROUND


Alcohol use disorder (AUD) confers a prodigious burden of disease, disability, premature mortality, and high economic costs from lost productivity, accidents, violence, incarceration, and increased healthcare utilization. For over 80 years, Alcoholics Anonymous (AA) has been a widespread AUD recovery organization, with millions of members and treatment free at the point of access, but it is only recently that rigorous research on its effectiveness has been conducted.
OBJECTIVES


To evaluate whether peer-led AA and professionally-delivered treatments that facilitate AA involvement (Twelve-Step Facilitation (TSF) interventions) achieve important outcomes, specifically: abstinence, reduced drinking intensity, reduced alcohol-related consequences, alcohol addiction severity, and healthcare cost offsets.
SEARCH METHODS


We searched the Cochrane Drugs and Alcohol Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, CINAHL and PsycINFO from inception to 2 August 2019. We searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 15 November 2018. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and bibliographies of included studies.
SELECTION CRITERIA


We included randomized controlled trials (RCTs), quasi-RCTs and non-randomized studies that compared AA or TSF (AA/TSF) with other interventions, such as motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT), TSF treatment variants, or no treatment. We also included healthcare cost offset studies. Participants were non-coerced adults with AUD.
DATA COLLECTION AND ANALYSIS


We categorized studies by: study design (RCT/quasi-RCT; non-randomized; economic); degree of standardized manualization (all interventions manualized versus some/none); and comparison intervention type (i.e. whether AA/TSF was compared to an intervention with a different theoretical orientation or an AA/TSF intervention that varied in style or intensity). For analyses, we followed Cochrane methodology calculating the standard mean difference (SMD) for continuous variables (e.g. percent days abstinent (PDA)) or the relative risk (risk ratios (RRs)) for dichotomous variables. We conducted random-effects meta-analyses to pool effects wherever possible.
MAIN RESULTS


We included 27 studies containing 10,565 participants (21 RCTs/quasi-RCTs, 5 non-randomized, and 1 purely economic study). The average age of participants within studies ranged from 34.2 to 51.0 years. AA/TSF was compared with psychological clinical interventions, such as MET and CBT, and other 12-step program variants. We rated selection bias as being at high risk in 11 of the 27 included studies, unclear in three, and as low risk in 13. We rated risk of attrition bias as high risk in nine studies, unclear in 14, and low in four, due to moderate (> 20%) attrition rates in the study overall (8 studies), or in study treatment group (1 study). Risk of bias due to inadequate researcher blinding was high in one study, unclear in 22, and low in four. Risks of bias arising from the remaining domains were predominantly low or unclear. AA/TSF (manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) RCTs comparing manualized AA/TSF to other clinical interventions (e.g. CBT), showed AA/TSF improves rates of continuous abstinence at 12 months (risk ratio (RR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 2 studies, 1936 participants; high-certainty evidence). This effect remained consistent at both 24 and 36 months. For percentage days abstinent (PDA), AA/TSF appears to perform as well as other clinical interventions at 12 months (mean difference (MD) 3.03, 95% CI -4.36 to 10.43; 4 studies, 1999 participants; very low-certainty evidence), and better at 24 months (MD 12.91, 95% CI 7.55 to 18.29; 2 studies, 302 participants; low-certainty evidence) and 36 months (MD 6.64, 95% CI 1.54 to 11.75; 1 study, 806 participants; low-certainty evidence). For longest period of abstinence (LPA), AA/TSF may perform as well as comparison interventions at six months (MD 0.60, 95% CI -0.30 to 1.50; 2 studies, 136 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at 12 months, as measured by drinks per drinking day (DDD) (MD -0.17, 95% CI -1.11 to 0.77; 1 study, 1516 participants; moderate-certainty evidence) and percentage days heavy drinking (PDHD) (MD -5.51, 95% CI -14.15 to 3.13; 1 study, 91 participants; low-certainty evidence). For alcohol-related consequences, AA/TSF probably performs as well as other clinical interventions at 12 months (MD -2.88, 95% CI -6.81 to 1.04; 3 studies, 1762 participants; moderate-certainty evidence). For alcohol addiction severity, one study found evidence of a difference in favor of AA/TSF at 12 months (P < 0.05; low-certainty evidence). AA/TSF (non-manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) For the proportion of participants completely abstinent, non-manualized AA/TSF may perform as well as other clinical interventions at three to nine months follow-up (RR 1.71, 95% CI 0.70 to 4.18; 1 study, 93 participants; low-certainty evidence). Non-manualized AA/TSF may also perform slightly better than other clinical interventions for PDA (MD 3.00, 95% CI 0.31 to 5.69; 1 study, 93 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at nine months, as measured by DDD (MD -1.76, 95% CI -2.23 to -1.29; 1 study, 93 participants; very low-certainty evidence) and PDHD (MD 2.09, 95% CI -1.24 to 5.42; 1 study, 286 participants; low-certainty evidence). None of the RCTs comparing non-manualized AA/TSF to other clinical interventions assessed LPA, alcohol-related consequences, or alcohol addiction severity. Cost-effectiveness studies In three studies, AA/TSF had higher healthcare cost savings than outpatient treatment, CBT, and no AA/TSF treatment. The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate-certainty evidence).
AUTHORS' CONCLUSIONS


There is high quality evidence that manualized AA/TSF interventions are more effective than other established treatments, such as CBT, for increasing abstinence. Non-manualized AA/TSF may perform as well as these other established treatments. AA/TSF interventions, both manualized and non-manualized, may be at least as effective as other treatments for other alcohol-related outcomes. AA/TSF probably produces substantial healthcare cost savings among people with alcohol use disorder.",2020,"The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate-certainty evidence).
","['27 studies containing 10,565 participants (21 RCTs/quasi-RCTs, 5 non-randomized, and 1 purely economic study', 'Participants were non-coerced adults with AUD', 'people with alcohol use disorder', '93 participants; very low-certainty evidence) and PDHD (MD 2.09, 95% CI -1.24 to 5.42; 1 study, 286 participants; low-certainty evidence']","['TSF (AA/TSF', 'motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT), TSF', 'peer-led AA and professionally-delivered treatments that facilitate AA involvement (Twelve-Step Facilitation (TSF) interventions', 'theoretical orientation (e.g. CBT', 'AA/TSF', 'standardized manualization (all interventions manualized versus some/none); and comparison intervention type (i.e. whether AA/TSF']","['healthcare cost savings', 'potential cost savings', 'Cost-effectiveness studies', 'total medical care costs', 'rates of continuous abstinence at 12 months (risk ratio (RR', 'LPA, alcohol-related consequences, or alcohol addiction severity', 'relative risk (risk ratios (RRs', 'drinking intensity, reduced alcohol-related consequences, alcohol addiction severity, and healthcare cost offsets', 'moderate-certainty evidence) and percentage days heavy drinking (PDHD']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C4517496', 'cui_str': '1.24'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0048723', 'cui_str': 'phenylmethane sulfonyl fluoride'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086600', 'cui_str': 'Medical Care Costs'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]",806.0,0.200745,"The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate-certainty evidence).
","[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Kelly', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Recovery Research Institute, Center for Addiction Medicine, 151 Merrimac Street, 6th Floor, Boston, Massachusetts, USA, 02114.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Humphreys', 'Affiliation': 'Stanford University Stanford School of Medicine, Veterans Affairs and Stanford University Medical Centers, 401 North Quarry Road, Stanford, CA, USA.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Ferri', 'Affiliation': ""European Monitoring Centre for Drugs and Drug Addiction, Best practices, knowledge exchange and economic issues, Cais do Sodre' 1249-289 Lisbon, Lisbon, Portugal.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012880.pub2']
130,32309766,Is psychosexual therapy a reliable alternative to bupropion extended-release to promote the sexual function in infertile women? An RCT.,"Background


Various treatment methods are used to deal with sexual problems.
Objective


This study was applied to answer the question of whether psychosexual therapy (PST) can be a reliable alternative to bupropion extended-release (BUP ER) to promote sexual function in infertile women.
Materials and Methods


In this randomized clinical trial, 105 infertile women with sexual dysfunction were randomly allocated to three groups: PST, BUP ER, and a control group. The PST group participated in a total of eight 2-hr group sessions. In BUP ER group, 150 mg/day Bupropion ER was administered for eight weeks. The control group did not receive any interventions. The female sexual function index (FSFI) and a clinical interview were used to assess their sexual dysfunction.
Results


The mean pre-to-post treatment scores of FSFI and its subscales increased significantly in PST and BUP ER groups (except in the subscale of sexual pain) (p = 0.0001, p = 0.0001). The changes in the subjects were not significant in the control group. After adjusting for the baseline values, the results remained significant for the mean FSFI (p = 0.0001), and its subscales between the groups. Compared to the control group, a significant increase was observed in the mean FSFI (p = 0.0001, p = 0.002) and its subscales in the PST group and in the BUP ER group (except in the subscale of sexual pain). Comparison of two intervention methods showed that PST had the better effect on the sexual function improving (p = 0.0001) and its subscales (exempting the subscale of orgasm) than BUP ER.
Conclusion


PST can be considered not only a reliable alternative to pharmacotherapy; it also produces better results in terms of improving sexual function in infertile women.",2020,The mean pre-to-post treatment scores of FSFI and its subscales increased significantly in PST and BUP ER groups (except in the subscale of sexual pain),"['infertile women', '105 infertile women with sexual dysfunction']","['Bupropion ER', 'psychosexual therapy (PST', 'PST, BUP ER', 'BUP ER']","['FSFI and its subscales', 'sexual function', 'female sexual function index (FSFI', 'sexual function improving', 'subscale of sexual pain', 'mean FSFI']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C3805107', 'cui_str': 'Psychosexual therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",105.0,0.0268,The mean pre-to-post treatment scores of FSFI and its subscales increased significantly in PST and BUP ER groups (except in the subscale of sexual pain),"[{'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Pasha', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Basirat', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Farzan', 'Initials': 'F', 'LastName': 'Kheirkhah', 'Affiliation': 'Departments of Psychiatry, School of Medicine, Babol University of Medical Sciences, Babol, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i3.6714']
131,32309768,Role of resilience training on compromising of infertile couples' applicant for divorce: A cross-sectional study.,"Background


Divorce is a social issue, which challenges not only the structure of family but also of a society. Studies have shown that infertility affects the marital boredom. In addition, resilience training and emphasizing on increasing piety (religiousness) can help to decrease this boredom.
Objective


This study aimed to evaluate the resilience training effects on the compromising of infertile couples' applicant for divorce.
Materials and Methods


In this cross-sectional study, 100 infertile couples who had requested for divorce and referred to the Center for consolidation of the family foundation were enrolled. Participants were randomly divided in two categories (n= 50/each): the case group received some consultation classes on social services as well as resilience training by a consultant in 5 sessions lasting 2 hr. In total, 10 hr of treatment; while the control group just received the consultation and social services. Canner and Davidson questionnaires were utilized as pre- and posttest in both groups. Groups answered the resilience's criterion of Canner and Davidson.
Results


The resilience training significantly increased the compromises made by couples in the case group compared to the control (p  <  0.01). The results showed that 26% of members of the case group relinquished divorce, while 10% of control group members did the same; this difference was statistically significant (p  <  0.01).
Conclusion


The resilience training leads to increased psychological well-being elements and compromises in infertile couples.",2020,The resilience training significantly increased the compromises made by couples in the case group compared to the control (p  <  0.01).,"['infertile couples', '100 infertile couples who had requested for divorce and referred to the Center for consolidation of the family foundation were enrolled', ""infertile couples' applicant for divorce""]","['consultation classes on social services as well as resilience training by a consultant in 5 sessions lasting 2 hr', 'resilience training']",['Canner and Davidson questionnaires'],"[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0012828', 'cui_str': 'Divorce'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",100.0,0.0179847,The resilience training significantly increased the compromises made by couples in the case group compared to the control (p  <  0.01).,"[{'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Afshani', 'Affiliation': 'Department of Social Welfare, Social Sciences Faculty, Yazd University, Yazd, Iran.'}, {'ForeName': 'Seyed Mohammad Reza Ghaem', 'Initials': 'SMRG', 'LastName': 'Mohammadi', 'Affiliation': 'Islamic Azad University, Qeshm Branch, Qeshm, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Khani', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i3.6717']
132,32309769,Effects of clomiphene citrate plus estradiol or progesterone on endometrial ultrastructure: An RCT.,"Background


Pinopods concentrations in endometrial surface is a marker of implantation. Estradiol valerate (EV) was used to change the adverse effects of Clomiphene Citrate (CC) on the endometrium.
Objective


The goal was to assess whether there is a significant difference in the endometrial pinopods concentrations and other parameters after adding EV and progesterone to higher doses of CC.
Materials and Methods


In this prospective randomized clinical trial, a total of 30 women who did not respond to 100 mg of CC from February 2016 to June 2016 were evaluated. They were divided into three groups: group I) received 150 mg of CC alone, group II) CC with EV, and group III) CC plus progesterone. On day 21 of the menstrual cycle, endometrial biopsy, a blood sampling, and a scanning by electron microscopy were performed.
Results


On day 21 of the menstrual cycle, there was no significant difference in the pinopods concentrations (p = 0.641) and serum estrogen levels (p = 0.276) between groups. However, the Serum progesterone levels in group I was higher than the other two groups (p = 0.007) in the same day.
Conclusion


Since the addition of EV and progesterone to higher dosages of CC did not change the pinopods concentration and serum estrogen levels on day 21 of the menstrual cycle, and the serum progesterone levels was higher in CC alone group (i.e. group I) compared to other groups, it can be concluded that the anti-estrogenic effects of CC just appear on the endometrium and not on the plasma levels.",2020,"However, the Serum progesterone levels in group I was higher than the other two groups (p = 0.007) in the same day.
",['30 women who did not respond to 100 mg of CC from February 2016 to June 2016 were evaluated'],"['CC plus progesterone', 'Estradiol valerate (EV', 'Clomiphene Citrate (CC', 'clomiphene citrate plus estradiol or progesterone']","['pinopods concentration and serum estrogen levels', 'endometrial ultrastructure', 'serum estrogen levels', 'pinopods concentrations', 'Serum progesterone levels', 'serum progesterone levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041623', 'cui_str': 'ultrastructure'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}]",30.0,0.0169579,"However, the Serum progesterone levels in group I was higher than the other two groups (p = 0.007) in the same day.
","[{'ForeName': 'Robabeh', 'Initials': 'R', 'LastName': 'Taheripanah', 'Affiliation': 'Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kabir-Salmani', 'Affiliation': 'Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Favayedi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Zamaniyan', 'Affiliation': 'Department of Obstetrics and Gynecology, Infertility Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Malih', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Taheripanah', 'Affiliation': 'Department of Molecular and Cellular Sciences, Faculty of Advanced Sciences and Technology Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i3.6718']
133,32309770,The effect of acupuncture on the day of embryo transfer on the in vitro fertilization outcomes: An RCT.,"Background


Acupuncture is an adjunct therapy to support infertile women received in vitro fertilization (IVF) treatment; however, the efficacy of this approach needs more evaluation.
Objective


This randomized clinical trial (RCT) study aimed to evaluate the influence of acupuncture on reproductive outcomes in women undergoing IVF treatment.
Materials and Methods


The study was carried out on 186 participants who had undergone IVF treatment in the Mother and Child Hospital between September 2015 and February 2016. Subjects were randomly divided into three groups: Acupuncture 25 min before embryo transfer (ET) (ACU1 group, n = 62), acupuncture 25 min before and after ET (ACU2 group, n = 62), and ET without acupuncture (control group, n = 62). Pregnancy rates (biochemical, clinical, and ongoing) were evaluated and compared between groups.
Results


There were significant differences between the ACU1 group and the control group regarding biochemical (p = 0.005), clinical (p = 0.006), and ongoing (p = 0.007) pregnancies. Also, our results showed that two-session acupuncture (ACU2) lead to a significant reduction in frequency of biochemical (p = 0.002), clinical (p = 0.003), and ongoing (p = 0.01) pregnancy rates when compared to the one-session acupuncture (ACU1). No significant difference was found between the ACU2 and control groups regarding the aforementioned terms (p = 0.50).
Conclusion


Acupuncture 25 min before ET significantly increased the IVF outcomes in women undergoing IVF compared with no acupuncture. Repeating acupuncture 25 min after ET did not improve the IVF outcome.",2020,"There were significant differences between the ACU1 group and the control group regarding biochemical (p = 0.005), clinical (p = 0.006), and ongoing (p = 0.007) pregnancies.","['women undergoing IVF treatment', '186 participants who had undergone IVF treatment in the Mother and Child Hospital between September 2015 and February 2016']","['Acupuncture 25 min before embryo transfer (ET) (ACU1', 'Acupuncture', '\n\n\nAcupuncture', 'ACU1', 'acupuncture', 'acupuncture 25 min before and after ET (ACU2 group, n = 62), and ET without acupuncture']","['IVF outcome', 'frequency of biochemical', 'IVF outcomes', 'reproductive outcomes', 'Pregnancy rates (biochemical, clinical, and ongoing', 'pregnancy rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",186.0,0.0773767,"There were significant differences between the ACU1 group and the control group regarding biochemical (p = 0.005), clinical (p = 0.006), and ongoing (p = 0.007) pregnancies.","[{'ForeName': 'Alamtaj Samsami', 'Initials': 'AS', 'LastName': 'Dehghani', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kaynoosh', 'Initials': 'K', 'LastName': 'Homayouni', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kanannejad', 'Affiliation': 'Department of Immunology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Kanannejad', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i3.6719']
134,32251031,Intrathecal Morphine versus Intrathecal Hydromorphone for Analgesia after Cesarean Delivery: A Randomized Clinical Trial.,"BACKGROUND


Intrathecal opioids are routinely administered during spinal anesthesia for postcesarean analgesia. The effectiveness of intrathecal morphine for postcesarean analgesia is well established, and the use of intrathecal hydromorphone is growing. No prospective studies have compared the effectiveness of equipotent doses of intrathecal morphine versus intrathecal hydromorphone as part of a multimodal analgesic regimen for postcesarean analgesia. The authors hypothesized that intrathecal morphine would result in superior analgesia compared with intrathecal hydromorphone 24 h after delivery.
METHODS


In this single-center, double-blinded, randomized trial, 138 parturients undergoing scheduled cesarean delivery were randomized to receive 150 µg of intrathecal morphine or 75 µg of intrathecal hydromorphone as part of a primary spinal anesthetic and multimodal analgesic regimen; 134 parturients were included in the analysis. The primary outcome was the numerical rating scale score for pain with movement 24 h after delivery. Static and dynamic pain scores, nausea, pruritus, degree of sedation, and patient satisfaction were assessed every 6 h for 36 h postpartum. Total opioid consumption was recorded.
RESULTS


There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139). Opioid received in the first 24 h did not differ between groups (median [25th, 75th] oral morphine milligram equivalents for intrathecal hydromorphone 30 [7.5, 45.06] vs. intrathecal morphine 22.5 [14.0, 37.5], P = 0.769). From Kaplan-Meier analysis, the median time to first opioid request was 5.4 h for hydromorphone and 12.1 h for morphine (log-rank test P = 0.200).
CONCLUSIONS


Although the hypothesis was that intrathecal morphine would provide superior analgesia to intrathecal hydromorphone, the results did not confirm this. At the doses studied, both intrathecal morphine and intrathecal hydromorphone provide effective postcesarean analgesia when combined with a multimodal analgesia regimen.",2020,"There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139).","['Analgesia after Cesarean Delivery', '134 parturients were included in the analysis', 'women receiving cesarean delivery using pain score at 24 h as the primary outcome', '138 parturients undergoing scheduled cesarean delivery', 'postcesarean analgesia']","['intrathecal hydromorphone as part of a primary spinal anesthetic and multimodal analgesic regimen', 'Intrathecal Morphine', 'Intrathecal Hydromorphone', 'hydromorphone', 'intrathecal hydromorphone', 'morphine', 'Intrathecal opioids', 'intrathecal morphine and intrathecal hydromorphone', 'intrathecal hydromorphone and intrathecal morphine', 'intrathecal morphine']","['median time to first opioid request', 'Static and dynamic pain scores, nausea, pruritus, degree of sedation, and patient satisfaction', 'numerical rating scale score for pain with movement 24 h after delivery', 'breakthrough analgesic requirements', 'superior analgesia', 'pain scores', 'Total opioid consumption']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",138.0,0.536156,"There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139).","[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Sharpe', 'Affiliation': 'From the Departments of Anesthesiology and Peri-operative Medicine (E.E.S., R.J.M., K.W.A., D.A.O., R.L.J., A.K.J., A.D.N., H.P.S.) Obstetrics and Gynecology (V.E.T.) Health Sciences Research (D.R.S.), Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rochelle J', 'Initials': 'RJ', 'LastName': 'Molitor', 'Affiliation': ''}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Arendt', 'Affiliation': ''}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Torbenson', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Olsen', 'Affiliation': ''}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': ''}, {'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Jacob', 'Affiliation': ''}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Niesen', 'Affiliation': ''}, {'ForeName': 'Hans P', 'Initials': 'HP', 'LastName': 'Sviggum', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003283']
135,31509072,Condom Use for Sexually Transmitted Infection Prevention Among Hispanic Teenage Mothers: A Community-Based Randomized Trial.,"Background:  Hispanics experience a higher prevalence of sexually transmitted infections (STIs) than non-Hispanics. Specifically, Hispanic teenagers are more at risk for HIV, have close to four times the rate of primary and secondary syphilis, and close to two times the rate of chlamydia and gonorrhea compared with non-Hispanic white teenagers. Hispanic youth engage in sexual activity at a younger age than non-Hispanic white youth and are less likely to use condoms in these encounters, thereby contributing to increased rates of teenage pregnancy and STIs. Prevention of STIs is needed for unmarried Hispanic teenage mothers. The purpose of this study was to examine whether Project Mothers and Schools (Project MAS), a support program for parenting teenagers, changed condom use to prevent STIs among Hispanic participants.  Methods:  A longitudinal study was conducted among 84 Hispanic teenage mothers. Generalized estimating equations were used to identify factors associated with participants' reported condom use to prevent STIs.  Results:  Overall, participants were 3.21 times more likely to report condom use to prevent STIs from baseline to 12-month follow-up ( p  = 0.030). Those using condoms to prevent pregnancy at 12-month follow-up were significantly more likely to report using a condom to prevent STIs (OR = 3.23,  p  = 0.017).  Conclusions:  Participation in Program MAS improved condom use patterns for STI prevention. These services and supports have potential to change unmarried Hispanic teenage mothers' condom use behaviors and decrease STI infection disparities among the teenage Hispanic population.",2020,"Those using condoms to prevent pregnancy at 12-month follow-up were significantly more likely to report using a condom to prevent STIs (OR = 3.23,  p  = 0.017).  ","['Hispanic youth engage in sexual activity at a younger age than non-Hispanic white youth', 'unmarried Hispanic teenage mothers', 'Sexually Transmitted Infection Prevention', '84 Hispanic teenage mothers', 'Hispanic Teenage Mothers', 'Project Mothers and Schools (Project MAS), a support program for parenting teenagers, changed condom use to prevent STIs among Hispanic participants', 'Hispanic teenagers']",['STIs'],['rate of chlamydia and gonorrhea'],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]","[{'cui': 'C0036916', 'cui_str': 'STDs'}]","[{'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}]",,0.0556268,"Those using condoms to prevent pregnancy at 12-month follow-up were significantly more likely to report using a condom to prevent STIs (OR = 3.23,  p  = 0.017).  ","[{'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Wilson', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Caroline D', 'Initials': 'CD', 'LastName': 'Bergeron', 'Affiliation': 'Institut national de santé publique du Québec, Quebec, Canada.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7455']
136,31339403,"Effect of Group-Task-Oriented Training on Gross and Fine Motor Function, and Activities of Daily Living in Children with Spastic Cerebral Palsy.","Aims:  To determine the effects of group-task-oriented training (group-TOT) on gross and fine motor function, activities of daily living (ADL) and social function of children with spastic cerebral palsy (CP). Methods:  Eighteen children with spastic CP (4-7.5 years, gross motor function classification system level I-III) were randomly assigned to the Group-TOT (9 children received group-TOT for 1 hour, twice a week for 8 weeks) or the comparison group (9 children received individualized traditional physical and occupational therapy). The Gross Motor Function Measure (GMFM)-88, the Bruininks-Oseretsky Test of Motor Proficiency 2 nd  edition (BOT-2), and the Pediatric Evaluation of Disability Inventory (PEDI) were administered before and after the intervention, and in the Group-TOT, 16 weeks after the intervention. Results:  Children in the Group-TOT showed significant improvements in the GMFM-88 standing and walking/running/jumping subscales, the BOT-2 manual dexterity subscale, and the PEDI social function subscale (p < 0.05); changes were maintained 16 weeks after the intervention ended. In contrast, the comparison group improved in only the BOT-2 fine motor integration subscale (p < 0.05). Conclusions:  The findings provide evidence of effectiveness of group-TOT in improving gross and fine motor function, and social function in children with CP.",2020,"showed significant improvements in the GMFM-88 standing and walking/running/jumping subscales, the BOT-2 manual dexterity subscale, and the PEDI social function subscale (p < 0.05); changes were maintained 16 weeks after the intervention ended.","['Children with Spastic Cerebral Palsy', 'children with CP', 'Eighteen children with spastic CP (4-7.5\u2009years, gross motor function classification system level I-III', 'children with spastic cerebral palsy (CP']","['group-task-oriented training (group-TOT', 'TOT', 'individualized traditional physical and occupational therapy', 'Group-Task-Oriented Training']","['BOT-2 fine motor integration subscale', 'Gross and Fine Motor Function, and Activities of Daily Living', 'gross and fine motor function, activities of daily living (ADL) and social function', 'GMFM-88 standing and walking/running/jumping subscales, the BOT-2 manual dexterity subscale, and the PEDI social function subscale', 'Gross Motor Function Measure (GMFM)-88, the Bruininks-Oseretsky Test of Motor Proficiency 2 nd  edition (BOT-2), and the Pediatric Evaluation of Disability Inventory (PEDI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}]","[{'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0562229', 'cui_str': 'Fine motor functions (observable entity)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",18.0,0.0162325,"showed significant improvements in the GMFM-88 standing and walking/running/jumping subscales, the BOT-2 manual dexterity subscale, and the PEDI social function subscale (p < 0.05); changes were maintained 16 weeks after the intervention ended.","[{'ForeName': 'Eun Jae', 'Initials': 'EJ', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'In Young', 'Initials': 'IY', 'LastName': 'Sung', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Moon', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Sook', 'Initials': 'JS', 'LastName': 'Yuk', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Heung-Su', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Nam Hyun', 'Initials': 'NH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, Seoul, Republic of Korea.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1642287']
137,30398957,Effects of Protein Versus Carbohydrate Supplementation on Markers of Immune Response in Master Triathletes: A Randomized Controlled Trial.,"Objective:  This study examines the long-term effects of ingesting hydrolyzed beef protein versus carbohydrate on indirect markers of immunity during 10 weeks of endurance training in master-aged triathletes ( n  = 16, age 35-60 years).  Methods:  Participants were randomly assigned to either a hydrolyzed beef protein (PRO,  n  = 8) or nonprotein isoenergetic carbohydrate (CHO,  n  = 8) condition, which consisted of ingesting 20 g of each supplement, mixed with water, once a day immediately post workout, or before breakfast on nontraining days. Salivary human neutrophil peptides (HNP1-3) were measured before and after performing an incremental endurance test to volitional exhaustion at both pre and post intervention. Additionally, baseline levels of platelets, neutrophils, eosinophil basophils, monocytes, and lymphocytes were determined at pre and post intervention.  Results:  No significant changes in baseline concentration and secretion rate of salivary HNP1-3 were observed for either treatment. The CHO group showed a nonsignificant decrease in resting HNP1-3 concentrations following the intervention ( p  = 0.052, effect size  d  = 0.53). Protein supplementation demonstrated a significant reduction in lymphocyte counts pre to post intervention (mean [SD]: 2.30 [0.57] vs. 1.93 [0.45] 10 3 /mm 3 ,  p  = 0.046,  d  = 0.77), along with a moderate but not statistically significant increase ( d  = 0.75,  p  = 0.051) of the neutrophil-to-lymphocyte ratio.  Conclusions:  In master-aged triathletes, postworkout ingestion of only protein, with no carbohydrate, may not be as effective as carbohydrate alone to attenuate negative long-term changes of some salivary and cellular immunological markers. Future studies should consider the co-ingestion of both macronutrients.",2019,"The CHO group showed a nonsignificant decrease in resting HNP1-3 concentrations following the intervention ( p  = 0.052, effect size  d  = 0.53).","['Master Triathletes', 'master-aged triathletes ( n \u2009=\u200916, age 35-60\u2009years']","['endurance training', 'ingesting hydrolyzed beef protein versus carbohydrate', 'Protein Versus Carbohydrate Supplementation', 'hydrolyzed beef protein (PRO,  n \u2009=\u20098) or nonprotein isoenergetic carbohydrate (CHO,  n \u2009=\u20098) condition']","['baseline levels of platelets, neutrophils, eosinophil basophils, monocytes, and lymphocytes', 'lymphocyte counts pre', 'baseline concentration and secretion rate of salivary HNP1-3', 'Markers of Immune Response', 'resting HNP1-3 concentrations']","[{'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C3538953', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.0889108,"The CHO group showed a nonsignificant decrease in resting HNP1-3 concentrations following the intervention ( p  = 0.052, effect size  d  = 0.53).","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Naclerio', 'Affiliation': 'a Department of Life and Sport Science, Faculty of Engineering and Science , University of Greenwich , London , United Kingdom.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'b Clinical Research Institute, Texas Tech University Health Sciences Center , Lubbock , Texas , USA.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Seijo', 'Affiliation': 'a Department of Life and Sport Science, Faculty of Engineering and Science , University of Greenwich , London , United Kingdom.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ashrafi', 'Affiliation': 'a Department of Life and Sport Science, Faculty of Engineering and Science , University of Greenwich , London , United Kingdom.'}, {'ForeName': 'Birthe V', 'Initials': 'BV', 'LastName': 'Nielsen', 'Affiliation': 'a Department of Life and Sport Science, Faculty of Engineering and Science , University of Greenwich , London , United Kingdom.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'c Exercise Science and Nutrition Laboratory , Texas A&M University , College Station , Texas , USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1528906']
138,30084900,"Safety and Efficacy of a Scar Cream Consisting of Highly Selective Growth Factors Within a Silicone Cream Matrix: A Double-Blinded, Randomized, Multicenter Study.","BACKGROUND


Several growth factors and hyaluronic acid are implicated in fetal scarless healing. Whether these factors can be applied to an adult scar to improve scar characteristics is unknown.
OBJECTIVES


This study compared the efficacy and safety of SKN2017B, a proprietary topical cream consisting of selective synthetic recombinant human growth factors and hyaluronic acid in a silicone base containing a specifically formulated silicone cream for postsurgical scar treatment.
METHODS


In this prospective, randomized, controlled, double-blinded study, unilateral or bilateral facial or truncal scars in adult surgical patients were randomly treated with SKN2017B or silicone cream. Study investigators, study patients, and 2 independent reviewers assessed improvement in scar characteristics after 4 and 12 weeks of treatment.
RESULTS


Forty-nine bilateral and 12 unilateral scars in 45 patients were treated with SKN2017B or silicone. At 12 weeks, investigators rated 74% of scars treated with SKN2017B as showing overall improvement vs 54% of silicone-treated scars, a 73% relative improvement with SKN2017B (P < 0.0001). Patients rated a moderate-to-significant improvement in 85% of SKN2017B-treated scars vs 51% of silicone-treated scars, a 67% relative improvement with SKN2017B (P < 0.001). Independent reviewers rated 87% of scars treated with SKN2017B to be better overall vs 1% of scars treated with silicone (P < 0.0001). There were no tolerability issues or adverse reactions with either cream.
CONCLUSIONS


SKN2017B consists of highly selective growth factors within a silicone cream matrix and is well tolerated and effective for surgical scar management.
LEVEL OF EVIDENCE: 1


",2019,"There were no tolerability issues or adverse reactions with either cream.
","['adult surgical patients', 'Forty-nine bilateral and 12 unilateral scars in 45 patients']","['unilateral or bilateral facial or truncal scars', 'SKN2017B or silicone', 'SKN2017B or silicone cream', 'SKN2017B', 'Silicone Cream Matrix', 'Scar Cream Consisting of Highly Selective Growth Factors']","['tolerability issues or adverse reactions', 'scar characteristics', 'Safety and Efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",45.0,0.111641,"There were no tolerability issues or adverse reactions with either cream.
","[{'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Zoumalan', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Shiva C', 'Initials': 'SC', 'LastName': 'Tadayon', 'Affiliation': 'Private oculoplastic surgery practice in Los Angeles, CA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Roostaeian', 'Affiliation': 'Department of Plastic Surgery, UCLA David Geffen School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Rossi', 'Affiliation': 'Dermatology Service, Memorial Sloan Kettering Center, New York, NY.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Gabriel', 'Affiliation': 'Department of Plastic Surgery, Loma Linda University Medical Center, Loma Linda, CA.'}]",Aesthetic surgery journal,['10.1093/asj/sjy185']
139,31970796,Elicitation of prior probability distributions for a proposed Bayesian randomized clinical trial of whole blood for trauma resuscitation.,"BACKGROUND


Whole blood trauma resuscitation is conceptually appealing and increasingly used but lacks evidence. A randomized controlled trial is needed but challenging to design. A Bayesian approach might be more efficient and more interpretable than a conventional frequentist design. We report the results on an elicitation meeting to create prior probability distributions to help develop such a trial.
METHODS


In-person expert elicitation meeting, based on Sheffield Elicitation Framework methodology. We used an interactive graphical tool to elicit the quantities of interest (24-hour mortality and certainty required). Two rounds were conducted, with an intervening discussion of deidentified responses. Individual responses were aggregated into probability distributions.
RESULTS


Fifteen experts participated. The pooled belief was that the median 24-hour mortality of trauma patients with hemorrhagic shock treated with component therapy (the current standard of care) was 19% (95% credible interval [CrI], 6%-45%), and the median 24-hour mortality of those treated with whole blood, 16% (95% CrI, 5%-39%). The pooled prior distribution for the relative risk had a median of 0.84 (95% CrI, 0.26-3.1), indicating that the expert group had a 64% prior belief that whole blood decreases 24-hour mortality compared to component therapy.
CONCLUSIONS


Experts had moderately strong beliefs that whole blood reduces the 24-hour mortality of trauma patients with hemorrhagic shock. These data will assist with the design and planning of a Bayesian trial of whole blood resuscitation, which will help to answer a key question in contemporary transfusion practice.",2020,"The pooled prior distribution for the relative risk had a median of 0.84 (95% CrI, 0.26-3.1), indicating that the expert group had a 64% prior belief that whole blood decreases 24-hour mortality compared to component therapy.
","['In-person expert elicitation meeting, based on Sheffield Elicitation Framework methodology', 'Fifteen experts participated', 'trauma patients with hemorrhagic shock']",[],"['median 24-hour mortality', '24-hour mortality']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",2.0,0.0639189,"The pooled prior distribution for the relative risk had a median of 0.84 (95% CrI, 0.26-3.1), indicating that the expert group had a 64% prior belief that whole blood decreases 24-hour mortality compared to component therapy.
","[{'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Jansen', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Harvin', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Richman', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Elenir', 'Initials': 'E', 'LastName': 'Avritscher', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Shannon W', 'Initials': 'SW', 'LastName': 'Stephens', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Van Thi Thanh', 'Initials': 'VTT', 'LastName': 'Truong', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Marisa B', 'Initials': 'MB', 'LastName': 'Marques', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Jose-Miguel', 'Initials': 'JM', 'LastName': 'Yamal', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}]",Transfusion,['10.1111/trf.15675']
140,31498394,"Reduction of Opioid Use by Acupuncture in Patients Undergoing Hematopoietic Stem Cell Transplantation: Secondary Analysis of a Randomized, Sham-Controlled Trial.","OBJECTIVE


To evaluate acupuncture as a nonpharmacologic intervention for pain management in patients undergoing hematopoietic stem cell transplantation (HSCT).
METHODS


Adult patients with multiple myeloma undergoing high-dose melphalan chemotherapy and autologous peripheral blood HSCT were randomized to receive either true (TA) or sham acupuncture (SA) once daily for five days starting on the day after chemotherapy. Use of pain medications and pain scores were assessed at baseline and at days 5, 15, and 30 after transplantation.
RESULTS


Among 60 evaluable subjects, the SA group (vs TA) had greater than five times odds of increasing pain medication use from baseline. Among patients who were opioid nonusers at baseline, all 15 patients in the TA group remained free from opioid use at the end of the study. In contrast, 20% of those in the SA group (four of the 20 patients) started to use opioids after chemotherapy and stem cell infusion (day 5) and 40% (eight of the 20) had become opioid users by day 30 after HSCT (Fisher exact test P = 0.006). Among patients who were taking opioids at baseline, 14% in the TA group vs 10% in the SA group increased opioid intake at day 5, and 21% (TA) vs 30% (SA) at day 30 (P = 0.86).
CONCLUSIONS


Acupuncture appears to significantly reduce the need for pain medications during HSCT and the number of post-HSCT opioid users among baseline opioid nonusers. It warrants further studies as an opioid-sparing intervention for pain in HSCT patients.",2020,"Among 60 evaluable subjects, the SA group (vs TA) had greater than five times odds of increasing pain medication use from baseline.","['pain in HSCT patients', 'Adult patients with multiple myeloma undergoing high-dose melphalan chemotherapy and autologous peripheral blood HSCT', 'Patients Undergoing Hematopoietic Stem Cell Transplantation', 'patients undergoing hematopoietic stem cell transplantation (HSCT']","['true (TA) or sham acupuncture (SA', 'acupuncture', 'Acupuncture', 'HSCT']","['pain medications', 'opioid intake', 'pain medication', 'pain medications and pain scores']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.17403,"Among 60 evaluable subjects, the SA group (vs TA) had greater than five times odds of increasing pain medication use from baseline.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Deng', 'Affiliation': 'Integrative Medicine Service.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Chung', 'Affiliation': 'Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Landau', 'Affiliation': 'Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siman', 'Affiliation': 'Seattle Cancer Care Alliance, Seattle, Washington.'}, {'ForeName': 'Qing S', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Lapen', 'Affiliation': 'Medical School, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz190']
141,32320729,Randomized in situ trial on the efficacy of Carbopol in enhancing fluoride / stannous anti-erosive properties.,"OBJECTIVE


To evaluate if the bioadhesive polymer (Carbopol 980) could potentiate the protective effect of sodium fluoride with stannous chloride (FS) solution on the control of enamel erosive wear.
METHODS


Cylindrical bovine enamel specimens were polished and randomly allocated into three groups (n = 60): FS (500 ppm F -  +800 ppm Sn 2+  - positive control), FS + Carbopol (0.1% Carbopol), and ultrapure water (negative control). A randomized double-blind cross-over in situ model with three phases was used. In each phase, volunteers (n = 15) used a palatal appliance containing 4 specimens: two were submitted to an erosion model (2 h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5 min, 4x/day; 1 h intervals of saliva exposure; and treatment with the test solutions for 1 min, 2x/day). Besides erosion, the other two specimens were also subjected to abrasion (2x/day, 15 s) with active electric toothbrush, before the treatment with the solutions. After 5 days, enamel surface loss (μm) was evaluated by profilometry. Data were analyzed by two-way RM-ANOVA and Tukey tests (5%).
RESULTS


There were significant differences for both challenge and treatment factors. Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05). The surface loss values for the erosion/remineralization model were (means ± SL): C = 14.7 ± 5.8b; FS = 9.0 ± 7.5ab; FS + Carbopol = 5.9 ± 3.8a; and for erosion/abrasion: C = 26.6 ± 10.1c; FS = 15.0 ± 8.8b; FS + Carbopol = 12.3 ± 7.9ab.
CONCLUSION


The association of Carbopol to the FS solution significantly protected the enamel against erosive wear, but it was not significantly superior to FS only.
CLINICAL SIGNIFICANCE


Under highly erosive and abrasive conditions, rinsing with solutions containing sodium fluoride plus stannous chloride, associated or not with the Carbopol polymer, is an effective approach to control enamel erosive wear.",2020,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"['Cylindrical bovine enamel specimens', 'enamel erosive wear']","['sodium fluoride plus stannous chloride', 'FS (500\u2009ppm F- +800\u2009ppm', 'sodium fluoride with stannous chloride (FS) solution', 'Carbopol', 'bioadhesive polymer (Carbopol 980', 'palatal appliance containing 4 specimens: two were submitted to an erosion model (2\u2009h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5\u2009min, 4x/day; 1\u2009h intervals of saliva exposure']",['enamel loss'],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0108434', 'cui_str': 'Carbopol'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1542809', 'cui_str': 'Carbopol 980'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0322465,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"[{'ForeName': 'Daniele Mara da Silva', 'Initials': 'DMDS', 'LastName': 'Ávila', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: daniele-mara@uol.com.br.'}, {'ForeName': 'Rayssa Ferreira', 'Initials': 'RF', 'LastName': 'Zanatta', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil; Department of Restorative Dentistry, Dental School, University of Taubaté, Taubaté, Brazil. Electronic address: zanatta.rayssa@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, São Paulo University-USP, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Idalina Vieira', 'Initials': 'IV', 'LastName': 'Aoki', 'Affiliation': 'Department of Chemical Engineering, Polytechnic School, São Paulo University-USP, São Paulo, Brazil. Electronic address: idavaoki@usp.br.'}, {'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103347']
142,32243644,Acute effects of breaking up prolonged sedentary time on cardiovascular disease risk markers in adults with paraplegia.,"Elevated levels of cardiovascular disease (CVD) risk markers are highly prevalent in people with a spinal cord injury (SCI). Breaking up prolonged sedentary time with short, regular bouts of physical activity can reduce postprandial glucose and lipid levels in able-bodied individuals. The effects in people with paraplegia are unknown. The study aims were to examine the acute postprandial glucose (primary aim), lipid, blood pressure, and psychological responses (secondary aims) to breaking up prolonged sedentary time in individuals with paraplegia. This was a randomized crossover design trial. Fourteen participants with paraplegia (age 51 ± 9 years, trunk fat mass 44.3 ± 7.7%) took part in the following two, 5.5-hour conditions: (1) uninterrupted sedentary time (SED), and (2) sedentary time interrupted with 2 minutes of moderate-intensity arm crank ergometer physical activity every 20 minutes (SED-ACT). Standardized breakfast and lunch test meals were consumed during each condition. The outcomes were compared between conditions using linear mixed models. Glucose area under the curve (AUC) was significantly lower during the lunch postprandial period in SED-ACT vs SED (incremental AUC 1.9 [95% CI 1.0, 2.7) and 3.0 [2.1, 3.9] mmol/L∙2.5 hour, respectively, P = .015, f = 0.34). There were no differences between conditions for the breakfast or total 5.5 hours postprandial periods (P > .05). Positive affect was higher in SED-ACT than SED (P = .001). Breaking up prolonged sedentary time acutely attenuates lunch postprandial glucose and improves positive affect in people with paraplegia. This may have clinical relevance for reducing CVD risk and improving psychological well-being in this population.",2020,"Glucose area under the curve (AUC) was significantly lower during the lunch postprandial period in SED-ACT versus SED (incremental AUC 1.9 [95% CI 1.0, 2.7) and 3.0 [2.1, 3.9] mmol/L∙2.5 h, respectively, p=0.015, f=0.34).","['individuals with paraplegia', 'adults with paraplegia', 'able-bodied individuals', 'people with a spinal cord injury (SCI', 'Fourteen participants with paraplegia (age 51±9 years, trunk fat mass 44.3±7.7%) took part in the following two, 5.5 h conditions: (1) uninterrupted sedentary time (SED), and (2', 'people with paraplegia']","['breaking up prolonged sedentary time', 'sedentary time interrupted with 2 min of moderate-intensity arm crank ergometer physical activity every 20 min (SED-ACT']","['acute postprandial glucose (primary aim), lipid, blood pressure and psychological responses', 'postprandial glucose and lipid levels', 'cardiovascular disease risk markers', 'Elevated levels of cardiovascular disease (CVD) risk markers', 'Glucose area under the curve (AUC']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",14.0,0.206326,"Glucose area under the curve (AUC) was significantly lower during the lunch postprandial period in SED-ACT versus SED (incremental AUC 1.9 [95% CI 1.0, 2.7) and 3.0 [2.1, 3.9] mmol/L∙2.5 h, respectively, p=0.015, f=0.34).","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Bailey', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Withers', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}, {'ForeName': 'Vicky L', 'Initials': 'VL', 'LastName': 'Goosey-Tolfrey', 'Affiliation': 'School of Sport, Exercise and Health Sciences, The Peter Harrison Centre for Disability Sport, Loughborough University, Loughborough, UK.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Vic., Australia.'}, {'ForeName': 'Christof A', 'Initials': 'CA', 'LastName': 'Leicht', 'Affiliation': 'School of Sport, Exercise and Health Sciences, The Peter Harrison Centre for Disability Sport, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Rachael B', 'Initials': 'RB', 'LastName': 'Champion', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}, {'ForeName': 'Opie P', 'Initials': 'OP', 'LastName': 'Charlett', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ferrandino', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13671']
143,31282292,Community-Based Upper Extremity Power Training for Youth with Cerebral Palsy: A Pilot Study.,"Aim:  To examine the effects of an upper-extremity, community-based, and power-training intervention. Methods:  Twelve participants with cerebral palsy (CP) [8 males, 4 females; mean age 14 years 6 months (SD 5 years 4 months), range 7-24] were randomly assigned to a rest-training (RT;  n  = 6) or training-rest ( n  = 6) group in this randomized, cross-over design. Training took place in participants' home or school, three times per week for 6 weeks. We examined changes in upper extremity average power output (Pavg) in watts (W) and changes in function via the Pediatric Outcomes Data Collection Instrument (PODCI). Results:  Each participant completed at least 15 of the 18 total training sessions (91.2% adherence). Pavg increased 92.2% on average among participants ( p  < .05). There was a significant three-way interaction among treatment, sequence, and period with the data stratified by (Bimanual Fine Motor Function [BFMF]) level on the pain subscale of the PODCI ( p  = 0.0118). All participants decreased pain after training with the exception of individuals with lower functioning (BFMF II-V) in the RT group. Conclusion:  A community-based upper extremity power-training intervention was feasible and effective at improving power among young people with CP and has the potential to improve pain.",2020,A community-based upper extremity power-training intervention was feasible and effective at improving power among young people with CP and has the potential to improve pain.,"['mean age 14 years 6 months (SD 5 years 4 months), range 7-24', 'young people with CP', 'Twelve participants with cerebral palsy (CP) [8 males, 4 females', 'Youth with Cerebral Palsy']","['upper-extremity, community-based, and power-training intervention', 'rest-training (RT;  n \u2009=\u20096) or training-rest', 'Community-Based Upper Extremity Power Training', 'community-based upper extremity power-training intervention']","['pain subscale of the PODCI', 'upper extremity average power output (Pavg) in watts (W) and changes in function via the Pediatric Outcomes Data Collection Instrument (PODCI', 'pain']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0439261', 'cui_str': 'watt (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",12.0,0.0137529,A community-based upper extremity power-training intervention was feasible and effective at improving power among young people with CP and has the potential to improve pain.,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Colquitt', 'Affiliation': 'Department of Health Sciences and Kinesiology, Georgia Southern University, Statesboro, GA, USA.'}, {'ForeName': 'Keagan', 'Initials': 'K', 'LastName': 'Kiely', 'Affiliation': 'Department of Health Sciences and Kinesiology, Georgia Southern University, Statesboro, GA, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Caciula', 'Affiliation': 'Department of Fitness, Exercise and Sports, New Jersey City University, Jersey City, NJ, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences and Kinesiology, Georgia Southern University, Statesboro, GA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Vogel', 'Affiliation': 'Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, GA, USA.'}, {'ForeName': 'Noelle G', 'Initials': 'NG', 'LastName': 'Moreau', 'Affiliation': 'Department of Physical Therapy, Louisiana State University Health Sciences Center, New Orleans, LA, USA.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1636924']
144,32320537,The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance.,"INTRODUCTION


High-frequency chest wall oscillation (HFCWO) is a commonly prescribed airway clearance technique (ACT) for patients whose ability to expectorate sputum is compromised. This study aimed to assess the effectiveness of a newly developed mobile ACT device (mHFCWO-The Monarch Airway Clearance System) in patients with cystic fibrosis (CF). A standard nonmobile HFCWO device (sHFCWO) was used as a comparator.
METHODOLOGY


This was a randomized, open-label, crossover pilot study. CF patients were treated with each device. Sputum was collected during and after each therapy session, while spirometry tests, Brody score assessment and functional respiratory imaging were performed before and after treatments.
RESULTS


Wet weight of sputum collected during and after treatment was similar for mHFCWO and sHFCWO (6.53 ± 8.55 vs 5.80 ± 5.82; P = .777). Interestingly, the mHFCWO treatment led to a significant decrease in specific airway volume (9.55 ± 9.96 vs 8.74 ± 9.70 mL/L; P < .001), while increasing specific airway resistance (0.10 ± 0.16 vs 0.16 ± 0.23 KPA*S; P < .001). These changes were heterogeneously-distributed throughout the lung tissue and were greater in the distal areas, suggesting a shift of mucus. Changes were accompanied by an overall improvement in the Brody index (57.71 ± 16.55 vs 55.20 ± 16.98; P = .001).
CONCLUSION


The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.",2020,"The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.",['patients with cystic fibrosis (CF'],"['mobile high-frequency chest wall oscillation (HFCWO) device', 'mobile ACT device (mHFCWO-The Monarch Airway Clearance System', 'High-frequency chest wall oscillation (HFCWO', 'standard nonmobile HFCWO device (sHFCWO']","['specific airway resistance', 'specific airway volume', 'Brody index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0447732,"The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.","[{'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Leemans', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Belmans', 'Affiliation': 'Fluidda nv, Kontich, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Van Holsbeke', 'Affiliation': 'Fluidda nv, Kontich, Belgium.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Department of Medical Affairs, Hillrom Company Inc., St. Paul, Minnesota.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Vissers', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Ides', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Verhulst', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Van Hoorenbeeck', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}]",Pediatric pulmonology,['10.1002/ppul.24784']
145,31013507,Physician and Surrogate Agreement with Assisted Dying and Continuous Deep Sedation in Advanced Dementia in Switzerland.,"BACKGROUND


Assisted dying and continuous deep sedation (CDS) are controversial practices. Little is known about the perceptions of physicians and surrogates about these practices for patients with advanced dementia.
OBJECTIVES


To describe and compare physician and surrogate agreement with the use of assisted dying and CDS in advanced dementia.
DESIGN, SETTING, SUBJECTS


Physicians (n = 64) and surrogates (n = 168) of persons with advanced dementia were recruited as part of a randomized controlled trial in Switzerland that tested decision support tools in this population.
METHODS


At baseline, the participants were asked about their agreement with assisted dying and CDS in advanced dementia using the following response options: ""completely agree,"" ""somewhat agree,"" ""somewhat disagree,"" ""completely disagree,"" and ""do not know."" Multivariable logistic regressions compared the likelihood that surrogates versus physicians would completely or somewhat agree (vs. completely or somewhat disagree) with these practices.
RESULTS


The physicians and surrogates, respectively, had a mean age (SD) of 50.6 years (9.9) and 57.4 years (14.6); 46.9% (n = 30/64) and 68.9% (n = 115/167) were women. A total of 20.3% (n = 13/64) of the physicians and 47.0% (n = 79/168) of the surrogates agreed with assisted dying in advanced dementia. Surrogates were significantly more likely to agree with this practice than physicians (adjusted odds ratio, 3.87; 95% CI: 1.94, 7.69). With regard to CDS, 51.6% (n = 33/64) of the physicians and 41.9% (n = 70/169) of the surrogates agreed with this practice, which did not differ significantly between the groups.
CONCLUSIONS


The surrogates were more agreeable to considering assisted dying in the setting of advanced dementia than the physicians, and about half of the participants in both groups reported CDS to be an appropriate option for this population.",2019,"Surrogates were significantly more likely to agree with this practice than physicians (adjusted odds ratio, 3.87; 95% CI: 1.94, 7.69).","['The physicians and surrogates, respectively, had a mean age (SD) of 50.6 years (9.9) and 57.4 years (14.6); 46.9% (n = 30/64) and 68.9% (n = 115/167) were women', 'Physicians (n = 64) and surrogates (n = 168) of persons with advanced dementia', 'patients with advanced dementia', 'Advanced Dementia in Switzerland']",['Assisted Dying and Continuous Deep Sedation'],[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}]",[],,0.083001,"Surrogates were significantly more likely to agree with this practice than physicians (adjusted odds ratio, 3.87; 95% CI: 1.94, 7.69).","[{'ForeName': 'Andrea Jutta', 'Initials': 'AJ', 'LastName': 'Loizeau', 'Affiliation': 'University Research Priority Program ""Dynamics of Healthy Aging,"" University of Zurich, Zurich, Switzerland, AndreaLoizeau@hsl.harvard.edu.'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Cohen', 'Affiliation': 'Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Theill', 'Affiliation': 'University Research Priority Program ""Dynamics of Healthy Aging,"" University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Eicher', 'Affiliation': 'University Research Priority Program ""Dynamics of Healthy Aging,"" University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'University Research Priority Program ""Dynamics of Healthy Aging,"" University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Riese', 'Affiliation': 'University Research Priority Program ""Dynamics of Healthy Aging,"" University of Zurich, Zurich, Switzerland.'}]",Neuro-degenerative diseases,['10.1159/000499113']
146,32317122,"Effect of Interpolated Questions on Podcast Knowledge Acquisition and Retention: A Double-Blind, Multicenter, Randomized Controlled Trial.","STUDY OBJECTIVE


We determine whether interpolated questions in a podcast improve knowledge acquisition and retention.
METHODS


This double-blinded controlled trial randomized trainees from 6 emergency medicine programs to listen to 1 of 2 versions of a podcast, produced de novo on the history of hypertension. The versions were identical except that 1 included 5 interpolated questions to highlight educational points (intervention). There were 2 postpodcast assessments, 1 within 48 hours of listening (immediate posttest) and a second 2 to 3 weeks later (retention test), consisting of the same 15 multiple-choice questions, 5 directly related to the interpolated questions and 10 unrelated. The primary outcome was the difference in intergroup mean assessment scores at each point. A sample size was calculated a priori to identify a significant interarm difference.
RESULTS


One hundred thirty-seven emergency medicine trainees were randomized to listen to a podcast, 69 without interpolated questions (control) and 68 with them (intervention). Although no significant difference was detected at the immediate posttest, trainees randomized to the interpolated arm had a significantly higher mean score on the retention test, with a 5.6% absolute difference (95% confidence interval 0.2% to 10.9%). For the material covered by the interpolated questions, the intervention arm had significantly higher mean scores on both the immediate posttest and retention tests, with absolute differences of 8.7% (95% confidence interval 1.6% to 15.8%) and 10.1% (95% confidence interval 2.8% to 17.4%), respectively. There was no significant intergroup difference for noninterpolated questions.
CONCLUSION


Podcasts containing interpolated questions improved knowledge retention at 2 to 3 weeks, driven by the retention of material covered by the interpolated questions. Although the gains may be modest, educational podcasters may improve knowledge retention by using interpolating questions.",2020,"For the material covered by the interpolated questions, the intervention arm had significantly higher mean scores on both the immediate posttest and retention tests, with absolute differences of 8.7% (95% confidence interval 1.6% to 15.8%) and 10.1% (95% confidence interval 2.8% to 17.4%), respectively.","['One hundred thirty-seven emergency medicine trainees', 'trainees from 6 emergency medicine programs to listen to 1 of 2 versions of a podcast, produced de novo on the history of hypertension']",['Interpolated Questions'],"['intergroup mean assessment scores', 'knowledge retention', 'knowledge acquisition and retention', 'Podcast Knowledge Acquisition and Retention']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}]",,0.242535,"For the material covered by the interpolated questions, the intervention arm had significantly higher mean scores on both the immediate posttest and retention tests, with absolute differences of 8.7% (95% confidence interval 1.6% to 15.8%) and 10.1% (95% confidence interval 2.8% to 17.4%), respectively.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weinstock', 'Affiliation': 'Adena Emergency Medicine Residency, Chillicothe, OH; Department of Emergency Medicine, Wexner Medical Center at The Ohio State University, Columbus, OH. Electronic address: mweinstock@mweinstock.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pallaci', 'Affiliation': 'Adena Emergency Medicine Residency, Chillicothe, OH; Ohio University Heritage College of Osteopathic Medicine, Athens, OH.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Aluisio', 'Affiliation': 'Department of Emergency Medicine, Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'Department of Emergency Medicine, McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), Houston TX.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Gottlieb', 'Affiliation': 'Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, Long Island Jewish Medical Center, Long Island, NY.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grock', 'Affiliation': 'Division of Emergency Medicine, Greater Los Angeles VA Healthcare System, and Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, LA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Frye', 'Affiliation': 'Adena Regional Medical Center, Chillicothe, OH.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Love', 'Affiliation': 'Department of Emergency Medicine, Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Orman', 'Affiliation': 'St. Charles Medical Center, Bend, OR.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Riddell', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.01.021']
147,32311723,Low-dose colchicine after MI reduced a composite ischemic cardiovascular outcome vs placebo.,,2020,,[],"['colchicine', 'placebo']",['composite ischemic cardiovascular outcome'],[],"[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.26607,,"[{'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Bach', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/ACPJ202004210-039']
148,32311295,"A Media Literacy-Based Nutrition Program Fosters Parent-Child Food Marketing Discussions, Improves Home Food Environment, and Youth Consumption of Fruits and Vegetables.","Background:  Media use is a known contributor to childhood obesity, but encouraging reductions in screen use only partially eliminates media influence. We tested a family-centered, media literacy-oriented intervention to empower parents and children 9-14 years to skillfully use media to reduce marketing influences, enhance nutrition knowledge, improve the selection of foods in the home environment, and improve fruit and vegetable consumption.  Methods:  A community-based, 6-U program included separate parent and youth (ages 9-14 years) sessions, each of which was followed by a session together in which skills from the individual sessions were reinforced. A pretest to posttest field test with control groups ( N  = 189, parent-child dyads) tested the intervention's efficacy.  Results:  Standardized mean differences from the multiple analysis of covariance tests showed that the intervention group demonstrated improvements on parents' use of nutrition labels (0.29), the ratio of healthy to unhealthy food in the home environment (0.25), youth's fruit (0.30) and vegetable (0.25) consumption, parent and youth media literacy skills, and family communication dynamics about food. The largest effects found were for negative parental mediation (0.48) and parents' report of child-initiated discussion (0.47). Consistent but weaker results were revealed for Latinx families.  Conclusions:  This family-centered approach helped family members practice using media together to make better nutrition decisions without depending on the ability of parents to limit media use. It successfully addressed the often-negative impact of the media on behaviors that increase obesity risk while also cultivating the potential for media to provide useful information that can lead to behaviors that decrease obesity risk.",2020,"Standardized mean differences from the multiple analysis of covariance tests showed that the intervention group demonstrated improvements on parents' use of nutrition labels (0.29), the ratio of healthy to unhealthy food in the home environment (0.25), youth's fruit (0.30) and vegetable (0.25) consumption, parent and youth media literacy skills, and family communication dynamics about food.",[],"['family-centered, media literacy-oriented intervention to empower parents and children 9-14 years to skillfully use media to reduce marketing influences, enhance nutrition knowledge, improve the selection of foods in the home environment, and improve fruit and vegetable consumption']","[""parents' use of nutrition labels""]",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}]",,0.0171726,"Standardized mean differences from the multiple analysis of covariance tests showed that the intervention group demonstrated improvements on parents' use of nutrition labels (0.29), the ratio of healthy to unhealthy food in the home environment (0.25), youth's fruit (0.30) and vegetable (0.25) consumption, parent and youth media literacy skills, and family communication dynamics about food.","[{'ForeName': 'Erica Weintraub', 'Initials': 'EW', 'LastName': 'Austin', 'Affiliation': 'Edward R. Murrow Center for Media and Health Promotion Research, Department of Strategic Communication, Edward R. Murrow College of Communication, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Austin', 'Affiliation': 'Department of Kinesiology and Educational Psychology, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Christopher Kit', 'Initials': 'CK', 'LastName': 'Kaiser', 'Affiliation': 'Department of Strategic Communication, The Edward R. Murrow College of Communication, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Zena', 'Initials': 'Z', 'LastName': 'Edwards', 'Affiliation': 'Food Safety and Nutrition, Washington State University Extension, Clark County, Vancouver, WA, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Power', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA, USA.'}]",Childhood obesity (Print),['10.1089/chi.2019.0240']
149,32317575,Forgot calcium? Admission ionized-calcium in two civilian randomized controlled trials of prehospital plasma for traumatic hemorrhagic shock.,"BACKGROUND


Randomized clinical trials (RCTs) support the use of prehospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most prehospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent prehospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that prehospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation. Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca of 1.0 mmol/L or less.
RESULTS


Of 160 subjects (76% men), 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34]). Prehospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03). Severe hypocalcemia was significantly associated with decreased survival (adjusted hazard ratio, 1.07; 95% CI, 1.02-1.13; p = 0.01) and massive transfusion (adjusted relative risk, 2.70; 95% CI, 1.13-6.46; p = 0.03), after adjustment for confounders (randomization group, age, ISS, and shock index).
CONCLUSION


Prehospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in prehospital hemotherapy.
LEVEL OF EVIDENCE


Therapeutic, level II.",2020,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","['160 subjects (76% men', 'Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible', ' 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34', 'traumatic hemorrhagic shock', 'We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation']",[],"['massive transfusion', 'survival', 'Severe hypocalcemia', 'rates of hypocalcemia', 'Hypocalcemia']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",160.0,0.491442,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'From the School of Medicine, Department of Surgery, University of Colorado Anschutz Medical Campus (H.B.M., E.E.M., M.J.C., M.P.C., A.S.), Aurora, CO; University of Colorado Anschutz Medical Campus, School of Public Health, Department of Health Systems, Management and Policy (A.S.); Aurora, Colorado; University of Pittsburgh (M.T.T., J.L.S., F.X.G., J.B.B., M.N., B.Z.), Pittsburgh, Pennsylvania; Ernest E. Moore Shock Trauma Center at Denver Health (E.E.M., M.J.C.), Denver, Colorado; and Combat Casualty Care Research Program (A.E.P.), US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': ''}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': ''}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
150,32314781,Dual-Outcome Intention-to-Treat Analyses in the Women's Health Initiative Randomized Controlled Hormone Therapy Trials.,"Dual-outcome intention-to-treat hazard rate analyses have potential to complement single-outcome analyses for the evaluation of treatments or exposures in relation to multivariate time-to-response outcomes. Here we consider pairs formed from important clinical outcomes to obtain further insight into influences of menopausal hormone therapy on chronic disease. As part of the Women's Health Initiative, randomized, placebo-controlled hormone therapy trials of conjugated equine estrogens (CEE) among posthysterectomy participants and of these same estrogens plus medroxyprogesterone acetate (MPA) among participants with an intact uterus were carried out at 40 US clinical centers (1993-2016). These data provide the context for analyses covering the trial intervention periods and a nearly 20-year (median) cumulative duration of follow-up. The rates of multiple outcome pairs were significantly influenced by hormone therapy, especially over cumulative follow-up, providing potential clinical and mechanistic insights. For example, among women randomized to either regimen, hazard ratios for pairs defined by fracture during intervention followed by death from any cause were reduced and hazard ratios for pairs defined by gallbladder disease followed by death were increased, though these findings may primarily reflect single-outcome associations. In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE + MPA, and those for hypertension followed by death were increased with CEE + MPA but not with CEE.",2020,"In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE+MPA, and for hypertension followed by death were increased with CEE+MPA but not with CEE.",['participants with uterus'],"['conjugated equine estrogens (CEE', 'estrogens plus medroxyprogesterone acetate (CEE+MPA', 'CEE+MPA', 'placebo']",['hazard ratios for diabetes followed by death'],"[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.125359,"In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE+MPA, and for hypertension followed by death were increased with CEE+MPA but not with CEE.","[{'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': ''}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': ''}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Banack', 'Affiliation': ''}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': ''}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Beverly M', 'Initials': 'BM', 'LastName': 'Snively', 'Affiliation': ''}, {'ForeName': 'Margery', 'Initials': 'M', 'LastName': 'Gass', 'Affiliation': ''}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ''}]",American journal of epidemiology,['10.1093/aje/kwaa033']
151,31799616,Multielectrode Transcranial Electrical Stimulation of the Left and Right Prefrontal Cortices Differentially Impacts Verbal Working Memory Neural Circuitry.,"Recent studies have examined the effects of conventional transcranial direct current stimulation (tDCS) on working memory (WM) performance, but this method has relatively low spatial precision and generally involves a reference electrode that complicates interpretation. Herein, we report a repeated-measures crossover study of 25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits. Shortly after each stimulation session, participants performed a verbal WM (VWM) task during magnetoencephalography, and the resulting data were examined in the time-frequency domain and imaged using a beamformer. We found that after left DLPFC stimulation, participants exhibited stronger responses across a network of left-lateralized cortical areas, including the supramarginal gyrus, prefrontal cortex, inferior frontal gyrus, and cuneus, as well as the right hemispheric homologues of these regions. Importantly, these effects were specific to the alpha-band, which has been previously implicated in VWM processing. Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus. These findings suggest that multielectrode tDCS targeting the left DLPFC affects the neural dynamics underlying offline VWM processing, including utilization of a more extensive bilateral cortical network.",2020,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","['25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits']",['conventional transcranial direct current stimulation (tDCS'],"['working memory (WM) performance', 'reaction time and response amplitude']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",25.0,0.0283869,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","[{'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Koshy', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Alex I', 'Initials': 'AI', 'LastName': 'Wiesman', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Spooner', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Embury', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rezich', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Heinrichs-Graham', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Tony W', 'Initials': 'TW', 'LastName': 'Wilson', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhz246']
152,32165263,Processing speed and attention training modifies autonomic flexibility: A mechanistic intervention study.,"Adaptation capacity is critical for maintaining cognition, yet it is understudied in groups at risk for dementia. Autonomic nervous system (ANS) is critical for neurovisceral integration and is a key contributor to adaptation capacity. To determine the central nervous system's top-down regulation of ANS, we conducted a mechanistic randomized controlled trial study, using a 6-week processing speed and attention (PS/A)-targeted intervention. Eighty-four older adults with amnestic mild cognitive impairment (aMCI) were randomized to a 6-week PS/A-targeted intervention or an active control without PS/A. Utilizing repeated measures (i.e., PS/A test different from the intervention, resting and cognitive task-based ECG, and resting fMRI) at baseline, immediately post-intervention (post-test), and 6-month follow-up, we aimed to test whether PS/A causally influences vagal control of ANS via their shared central neural pathways in aMCI. We indexed vagal control of ANS using high-frequency heart rate variability (HF-HRV) extracted from ECG data. Functional brain connectivity patterns were extracted from fMRI using advanced statistical tools. Compared to the control group, the intervention group showed significant improvement in PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity at post-test; the effect on SN, CEN, and FPN remained at 6-month follow-up. Changes in PS/A and SN connectivity significantly predicted change in HF-HRV from baseline to post-test and/or 6-month-follow-up. Age, neurodegeneration, nor sex did not affect these relationships. This work provides novel support for top-down regulation of PS/A and associated SN on vagal control of ANS. Intervening PS/A may be a viable approach for promoting adaptation capacity in groups at risk for dementia.",2020,"Compared to the control group, the intervention group showed significant improvement in PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity at post-test; the effect on SN, CEN, and FPN remained at 6-month follow-up.",['Eighty-four older adults with amnestic mild cognitive impairment (aMCI'],"['6-week PS/A-targeted intervention or an active control without PS/A. Utilizing repeated measures (i.e., PS/A test different from the intervention, resting and cognitive task-based ECG, and resting fMRI', 'Processing speed and attention training', '6-week processing speed and attention (PS/A)-targeted intervention']","['SN, CEN, and FPN', 'HF-HRV', 'PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0556509', 'cui_str': 'Attention training (regime/therapy)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}]",84.0,0.0735346,"Compared to the control group, the intervention group showed significant improvement in PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity at post-test; the effect on SN, CEN, and FPN remained at 6-month follow-up.","[{'ForeName': 'Feng V', 'Initials': 'FV', 'LastName': 'Lin', 'Affiliation': 'Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, University of Rochester Medical Center, USA; Department of Psychiatry, School of Medicine and Dentistry, University of Rochester Medical Center, USA; Department of Brain and Cognitive Sciences, University of Rochester, USA; Department of Neuroscience, School of Medicine and Dentistry, University of Rochester Medical Center, USA; Department of Neurology, School of Medicine and Dentistry, University of Rochester Medical Center, USA. Electronic address: FengVankee_Lin@urmc.rochester.edu.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Electrical and Computational Engineering, University of Rochester, USA.'}, {'ForeName': 'Quanjing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, University of Rochester Medical Center, USA; Department of Psychiatry, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Anthony', 'Affiliation': 'Department of Brain and Cognitive Sciences, University of Rochester, USA.'}, {'ForeName': 'Zhengwu', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatics and Computational Biology, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}, {'ForeName': 'Duje', 'Initials': 'D', 'LastName': 'Tadin', 'Affiliation': 'Department of Brain and Cognitive Sciences, University of Rochester, USA; Department of Neuroscience, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}, {'ForeName': 'Kathi L', 'Initials': 'KL', 'LastName': 'Heffner', 'Affiliation': 'Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, University of Rochester Medical Center, USA; Department of Psychiatry, School of Medicine and Dentistry, University of Rochester Medical Center, USA; Division of Geriatrics & Aging, Department of Medicine, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116730']
153,31972609,Application of Behavioral Economics Principles Improves Participation in Mailed Outreach for Colorectal Cancer Screening.,"INTRODUCTION


Colorectal cancer (CRC) is a major cause of cancer-related morbidity and mortality in the United States. Although various interventions have improved screening rates, they often require abundant resources and can be difficult to implement. Social psychology and behavioral economics principles offer an opportunity for low-cost and easy-to-implement strategies but are less common in clinical settings.
METHODS


We randomized 2,000 patients aged 50-75 years eligible for CRC screening to one of the 2 mailed interventions: a previously used text-based letter describing and offering fecal immunochemical testing (FIT) and colonoscopy (usual care arm); or a letter leveraging social psychology and behavioral economics principles (e.g., implied scarcity and choice architecture), minimal text, and multiple images to offer FIT and colonoscopy (intervention arm). We compared total screening uptake, FIT uptake, and colonoscopy uptake at 1-month intervals in each group.
RESULTS


There were 1,882 patients included in the final analysis. The mean age was 69.3 years, and baseline characteristics in the 2 groups were similar. Screening completion at 26 weeks was 19.5% in the usual care arm (16.3% FIT vs 3.2% colonoscopy, P < 0.01) and 24.1% in the intervention arm (22.1% FIT vs 2.0% colonoscopy, P < 0.01) (P = 0.02).
DISCUSSION


Among primary care patients aged 50-75 years in an academic setting, mailed CRC outreach employing social psychology and behavioral economics principles led to a higher participation in CRC screening than usual care mailed outreach.
TRANSLATIONAL IMPACT


Mailed interventions to increase CRC screening should incorporate social psychology and behavioral economics principles to improve participation.",2020,"Screening completion at 26 weeks was 19.5% in the usual care arm (16.3% FIT vs 3.2% colonoscopy, P < 0.01) and 24.1% in the intervention arm (22.1% FIT vs 2.0% colonoscopy, P < 0.01)","['Mailed Outreach for Colorectal Cancer Screening', '2,000 patients aged 50-75 years eligible for CRC screening to one of the 2 mailed interventions: a previously', 'primary care patients aged 50-75 years in an academic setting, mailed CRC outreach employing social psychology and behavioral economics principles led to a higher participation in CRC screening than usual care mailed outreach', '1,882 patients included in the final analysis']","['used text-based letter describing and offering fecal immunochemical testing (FIT) and colonoscopy (usual care arm); or a letter leveraging social psychology and behavioral economics principles (e.g., implied scarcity and choice architecture), minimal text, and multiple images to offer FIT and colonoscopy (intervention arm']","['total screening uptake, FIT uptake, and colonoscopy uptake']","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0033919', 'cui_str': 'Psychology, Social'}, {'cui': 'C1510587', 'cui_str': 'Economics, Behavioral'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0033919', 'cui_str': 'Psychology, Social'}, {'cui': 'C1510587', 'cui_str': 'Economics, Behavioral'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",2000.0,0.021882,"Screening completion at 26 weeks was 19.5% in the usual care arm (16.3% FIT vs 3.2% colonoscopy, P < 0.01) and 24.1% in the intervention arm (22.1% FIT vs 2.0% colonoscopy, P < 0.01)","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Bakr', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Afsar-Manesh', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Raja', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dermenchyan', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Shu', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Folasade P', 'Initials': 'FP', 'LastName': 'May', 'Affiliation': 'Tamar and Vatche Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000115']
154,31972610,Effects of High-Fiber Diets and Macronutrient Substitution on Bloating: Findings From the OmniHeart Trial.,"OBJECTIVES


To examine the effects of high-fiber, isocaloric, macronutrient substitutions on bloating.
METHODS


The OmniHeart study is a randomized 3-period crossover feeding trial conducted from April 2003 to June 2005. Participants were provided 3 isocaloric versions of high-fiber (∼30 g per 2,100 kcal) diet, each different in carbohydrate, protein, and unsaturated fat composition. Each feeding period lasted for 6 weeks with a 2- to 4-week washout period between diets. Participants reported the presence and severity of bloating at baseline (participants were eating their own diet) and at the end of each feeding period.
RESULTS


One hundred sixty-four participants were included in the analysis (mean age: 53.1 years; 45% women; 55% black). The prevalence of bloating at baseline and at the end of the carbohydrate-rich, protein-rich, and unsaturated fat-rich diet period was 18%, 24%, 33%, and 30%, respectively. Compared with baseline, the relative risk of bloating for the carbohydrate-rich, protein-rich, and unsaturated fat-rich high-fiber diet was 1.34 (95% confidence interval [CI]: 0.93, 1.92), 1.78 (95% CI: 1.32, 2.40), and 1.63 (95% CI: 1.17, 2.26), respectively. The protein-rich diet increased the risk of bloating more than the carbohydrate-rich diet (relative risk = 1.40; 95% CI: 1.03, 1.88). Bloating did not significantly vary between protein-rich vs unsaturated fat-rich or unsaturated fat-rich vs carbohydrate-rich diets. Black participants compared with non-black participants had a higher risk of bloating after all 3 versions of the high-fiber OmniHeart diet (P-value for interaction = 0.012).
DISCUSSION


Substitution of protein with carbohydrate may be an effective strategy to decrease bloating among individuals experiencing gastrointestinal bloating from a high-fiber diet.",2020,"The protein-rich diet increased the risk of bloating more than the carbohydrate-rich diet (relative risk = 1.40; 95% CI: 1.03, 1.88).","['April 2003 to June 2005', 'One hundred sixty-four participants were included in the analysis (mean age: 53.1 years; 45% women; 55% black']","['high-fiber, isocaloric, macronutrient substitutions', 'High-Fiber Diets and Macronutrient Substitution']","['prevalence of bloating', 'presence and severity of bloating', 'relative risk of bloating', 'risk of bloating', 'bloating', 'Bloating']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0301568', 'cui_str': 'High residue diet (finding)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",164.0,0.0323859,"The protein-rich diet increased the risk of bloating more than the carbohydrate-rich diet (relative risk = 1.40; 95% CI: 1.03, 1.88).","[{'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Pankaj Jay', 'Initials': 'PJ', 'LastName': 'Pasricha', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000122']
155,32026625,A proof-of-principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive.,"OBJECTIVES


This proof-of-principle, single-center, randomized, examiner-blind, crossover study compared two experimental polyvinyl acetate (PVA)-based denture adhesives (Test Adhesives 1 and 2) with a marketed reference polymethyl vinyl ether/maleic anhydride (PMV/MA)-based adhesive and no adhesive using incisal bite force area over baseline over 12 hr (AOB 0-12  ) in participants with an at least moderately well-fitting complete maxillary denture. Previous in vitro studies suggested the experimental denture adhesives provided superior performance.
MATERIALS AND METHODS


Participants were randomized to a treatment sequence such that each received each treatment once. Prior to treatment application (baseline) and at 0.5, 1, 3, 6, 9, and 12 hr following the application, participants bit on a force transducer until their maxillary denture dislodged. Between-treatment differences in AOB 0-12  were analyzed using analysis of covariance. For study validity, the reference adhesive was compared with no adhesive. Participants were asked to rate sensory experiences and ease of denture removal.
RESULTS


Twenty-three participants were included in the modified intent-to-treat population. Although Test Adhesives 1 and 2 had a higher mean AOB 0-12  than no adhesive, differences were not statistically significant. No statistically significant difference was also found between the reference adhesive and no adhesive; hence, study validity was not attained. Participants did not report any clear differences between the test or reference adhesives in terms of taste or feel; however, dentures were easier to remove with the test adhesives versus reference. No treatment-related adverse events were reported.
CONCLUSION


Neither the experimental PVA-based denture adhesives nor the PMV/MA-based reference product demonstrated a statistically significant difference in incisal bite force AOB 0-12  compared with no adhesive. The reasons for these unexpected results is unclear; they suggest that findings of in vitro tests for denture adhesive performance are not always translated to in vivo performance (Clinicaltrials.gov: NCT02937870).",2020,"Although Test Adhesives 1 and 2 had a higher mean AOB 0-12  than no adhesive, differences were not statistically significant.","['participants with an at least moderately well-fitting complete maxillary denture', 'Twenty-three participants were included in the modified intent-to-treat population', 'Participants']",['polyvinyl acetate (PVA)-based denture adhesives (Test Adhesives 1 and 2) with a marketed reference polymethyl vinyl ether/maleic anhydride (PMV/MA)-based adhesive and no adhesive'],"['incisal bite force AOB', 'adverse events', 'reference adhesive and no adhesive; hence, study validity', 'rate sensory experiences and ease of denture removal']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0011458', 'cui_str': 'Complete upper denture (physical object)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0071701', 'cui_str': 'polyvinyl acetate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0078264', 'cui_str': 'vinyl ether'}, {'cui': 'C0024577', 'cui_str': '2,5-Furandiones'}]","[{'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",23.0,0.120999,"Although Test Adhesives 1 and 2 had a higher mean AOB 0-12  than no adhesive, differences were not statistically significant.","[{'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Atassi', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Ling', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Oneglia', 'Affiliation': 'TKL Research, Bloomfield, NJ, USA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Dilauro', 'Affiliation': 'TKL Research, Bloomfield, NJ, USA.'}]",Clinical and experimental dental research,['10.1002/cre2.256']
156,32312337,Do infants of breast-feeding mothers benefit from additional long-chain PUFA from fish oil? A 6-year follow-up.,"Fish-oil supplements are marketed as enhancing intelligence and cognitive performance. However, empirical data concerning the utility of these products in healthy term infants are mixed, particularly with respect to lasting effects into childhood. We evaluated whether fish-oil supplementation during infancy leads to better neurocognitive/behavioural development at 6 years. We conducted a double-blind randomised controlled trial of supplementation with n-3 long-chain PUFA in 420 healthy term infants. Infants received either fish oil (containing at least 250 mg DHA and at least 60 mg EPA) or placebo (olive oil) daily from birth to 6 months of age. Neurodevelopmental follow-up was conducted at a mean age of 6 years (sd 7 months), whereby 335 children were assessed for language, executive functioning, global intelligence quotient and behaviour. No significant differences were observed between the groups for the main neurocognitive outcomes. However in parent-report questionnaire, fish-oil supplementation was associated with negative externalising (P = 0·035, d = 0·24) and oppositional/defiant behaviour (P = 0·006, d = 0·31), particularly in boys (P = 0·01, d = 0·45; P = 0·004, d = 0·40). Our results provide evidence that fish-oil supplementation to predominantly breast-fed infants confers no significant cognitive or behavioural benefit to children at 6 years.",2020,"However in parent-report questionnaire, fish-oil supplementation was associated with negative externalizing (P = 0.035, d = .24) and oppositional/defiant behaviour (P = 0.006, d = .31), particularly in boys (P = 0.01, d = .45 ; P = 0.004, d = .40).","['healthy term infants', '420 healthy term infants']","['supplementation with omega-3 long-chain polyunsaturated fatty acid (n-3 LCPUFA', 'fish oil supplementation', 'Fish-oil supplements', 'fish oil [containing at least 250 mg docosahexaenoic acid (DHA) and at least 60 mg eicosapentaenoic acid (EPA)] or placebo (olive oil', 'fish-oil supplementation']","['negative externalizing', 'oppositional/defiant behaviour', 'language, executive functioning, global IQ and behaviour']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0424348', 'cui_str': 'Defiant behavior'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",420.0,0.426369,"However in parent-report questionnaire, fish-oil supplementation was associated with negative externalizing (P = 0.035, d = .24) and oppositional/defiant behaviour (P = 0.006, d = .31), particularly in boys (P = 0.01, d = .45 ; P = 0.004, d = .40).","[{'ForeName': 'Suzanne J', 'Initials': 'SJ', 'LastName': 'Meldrum', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Heaton', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Foster', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Simmer', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}]",The British journal of nutrition,['10.1017/S000711452000135X']
157,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs microtubules, has androgen receptor (AR) inhibitory effects and is used in both the castration resistant and sensitive settings, where androgen dynamics may impact outcome. The present analysis evaluates the association of decline in serum androgen levels (Testosterone (T), Androstenedione (A) and DHEA in docetaxel-treated mCRPC patients with OS.
METHODS


Data from 1050 men treated on CALGB 90401 with docetaxel, prednisone and either bevacizumab or placebo were evaluated. Eligibility required progressive mCRPC and no prior chemotherapy. Pre-treatment, 6 week and progression serum assays for T, A and DHEA were performed via tandem Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Changes in T, A and DHEA levels from baseline to 6 weeks were calculated as the ratio of 6-week over baseline. The proportional hazards model was used to assess the prognostic significance of changes in T, A, and DHEA from baseline to 6 weeks in predicting OS adjusting for known prognostic factors.
RESULTS


Median baseline values for T, A, and, DHEA were 1.0, 13.5, and 8.1 ng/dL respectively while 6 week levels were 0.64, 7.0, and 6.8 ng/dL respectively. Median OS for low testosterone decline is 20.9 months vs 26.3 months for high testosterone decline. In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001). Decline in A and DHEA were not significant predictors of OS. In multivariable analysis change in the serum changes did not predict PFS however the ratio of T at 6-weeks over baseline was prognostic of ≥50% decline in PSA with an odds ratio of 0.93 (95% CI = 0.85-0.98, p-value = 0.039).
CONCLUSIONS


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
158,31961967,Six-dimensional quantitative DCE MR Multitasking of the entire abdomen: Method and application to pancreatic ductal adenocarcinoma.,"PURPOSE


To develop a quantitative DCE MRI technique enabling entire-abdomen coverage, free-breathing acquisition, 1-second temporal resolution, and T 1  -based quantification of contrast agent concentration and kinetic modeling for the characterization of pancreatic ductal adenocarcinoma (PDAC).
METHODS


Segmented FLASH readouts following saturation-recovery preparation with randomized 3D Cartesian undersampling was used for incoherent data acquisition. MR Multitasking was used to reconstruct 6-dimensional images with 3 spatial dimensions, 1 T 1  recovery dimension for dynamic T 1  quantification, 1 respiratory dimension to resolve respiratory motion, and 1 DCE time dimension to capture the contrast kinetics. Sixteen healthy subjects and 14 patients with pathologically confirmed PDAC were recruited for the in vivo studies, and kinetic parameters v p  , K trans  , v e  , and K ep  were evaluated for each subject. Intersession repeatability of Multitasking DCE was assessed in 8 repeat healthy subjects. One-way unbalanced analysis of variance was performed between control and patient groups.
RESULTS


In vivo studies demonstrated that v p  , K trans  , and K ep  of PDAC were significantly lower compared with nontumoral regions in the patient group (P = .002, .003, .004, respectively) and normal pancreas in the control group (P = .011, <.001, <.001, respectively), while v e  was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001). The kinetic parameters showed good in vivo repeatability (interclass correlation coefficient: v p  , 0.95; K trans  , 0.98; v e  , 0.96; K ep  , 0.99).
CONCLUSION


The proposed Multitasking DCE is promising for the quantification of vascular properties of PDAC. Quantitative DCE parameters were repeatable in vivo and showed significant differences between normal pancreas and both tumor and nontumoral regions in patients with PDAC.",2020,while v e  was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001).,"['8 repeat healthy subjects', 'patients with PDAC', 'Sixteen healthy subjects and 14 patients with pathologically confirmed PDAC', 'entire abdomen', 'pancreatic ductal adenocarcinoma']",['Multitasking DCE'],"['healthy pancreas', 'K trans  , and K ep  of PDAC', 'vivo repeatability']","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]",[],[],16.0,0.0351948,while v e  was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001).,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Gaddam', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Wensha', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Radiation Oncology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tuli', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hendifar', 'Affiliation': 'Department of Gastrointestinal Malignancies, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pandol', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Christodoulou', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Debiao', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}]",Magnetic resonance in medicine,['10.1002/mrm.28167']
159,32290859,Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol.,"BACKGROUND


Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood and the majority of young survivors experience impairing, distressing, and modifiable adverse outcomes that can persist long after medical treatment. These include psychological distress, impairment in pursuit of life goals, persistent physical side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated diurnal stress hormones). However, few targeted interventions exist to assist young survivors in renegotiating life goals and regulating cancer-related emotions, and none focus on reducing the burden of morbidity via biobehavioral mechanisms. This paper describes the methodology of a randomized controlled biobehavioral trial designed to investigate the feasibility and preliminary impact of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients.
METHODS


Participants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over 8 weeks. In addition to indicators of intervention feasibility, we will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T 0 ), immediately after (T 1 ), and 12 weeks after (T 2 ) intervention. Additionally, identified biomarkers will be measured at baseline and at T 2 .
DISCUSSION


GET may have the potential to improve self-regulation across biobehavioral domains, improve overall cancer adjustment, and address the need for targeted supportive care interventions for young adult cancer survivors.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT04150848. Registered on 28 October 2019.",2020,"BACKGROUND


Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood and the majority of young survivors experience impairing, distressing, and modifiable adverse outcomes that can persist long after medical treatment.","['Participants', 'young adult testicular cancer patients', 'young adult survivors of testicular cancer', 'young adult cancer survivors']","['GET or Individual Supportive Therapy (ISP', 'biobehavioral intervention protocol', 'Goal-Focused Emotion-Regulation Therapy (GET', 'novel intervention, Goal-focused Emotion-Regulation Therapy (GET']","['primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes', 'distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers', 'psychological distress, impairment in pursuit of life goals, persistent physical side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated diurnal stress hormones']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0153594', 'cui_str': 'Malignant tumor of testis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",,0.116773,"BACKGROUND


Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood and the majority of young survivors experience impairing, distressing, and modifiable adverse outcomes that can persist long after medical treatment.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Hoyt', 'Affiliation': 'Department of Population Health and Disease Prevention and the Chao Family Comprehensive Cancer Center, University of California, Irvine, 653 E Peltason Drive, Irvine, CA, 95697-3957, USA. mahoyt@uci.edu.'}, {'ForeName': 'Ashley Wei-Ting', 'Initials': 'AW', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Soochow University, Shinlin, Taiwan.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Psychology, Graduate Center, City University of New York, New York, NY, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Breen', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Cheavens', 'Affiliation': 'Department of Psychology, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Trials,['10.1186/s13063-020-04242-0']
160,32234355,Patient Education and Engagement Through Multimedia: A Prospective Pilot Study on Health Literacy in Patients with Cerebral Aneurysms.,"BACKGROUND


Improving the comprehension and communication of patient education materials could augment patient participation in shared clinical decision making. Inadequate healthcare-oriented educational resources for patients with a newly diagnosed complex disease, such as a cerebral aneurysm, can lead to an insufficient understanding of their ailment. As such, we hypothesized that a PowerPoint-style educational intervention with grade-conscious (i.e., sixth grade level) written material accompanied by visual graphics would help improve patient health literacy and satisfaction.
METHODS


A randomized prospective pilot study was conducted during a 1-year period in 2018. Preclinic encounter knowledge assessment surveys were administered to 52 patients with brain aneurysms (newly diagnosed or during follow-up) presenting for their neurosurgery outpatient clinic visit. The patients were assigned to 1 of 2 cohorts, with 26 each in the educational intervention group and control group, using a quasi-randomization method of alternating the assigned group for each successive patient. At the conclusion of their clinic encounter, all the patients completed a postclinic encounter knowledge assessment and satisfaction survey. Differences in covariates such as gender distribution, age, and family history of aneurysms were analyzed between the control and intervention groups.
RESULTS


The overall study cohort had a high baseline knowledge about cerebral aneurysms with an average preclinic encounter score of 5.37 on the 7-question survey. The educational intervention resulted in an upward trend in the patient knowledge scores. No statistically significant difference was detected in the patient satisfaction scores between the intervention and control groups. However, most of the patients receiving the educational intervention reported that the educational material was easy to understand (95.7%), helpful (86.9%), and relevant (87%) to their clinic visit.
CONCLUSION


Overall, in the present prospective study, the use of a multimedia-based educational intervention resulted in an upward trend in knowledge without a statistically significant difference in patient satisfaction scores compared with the control patients. To better measure the effectiveness of multimedia-based patient education interventions, future studies should account for the patients' baseline education level, preexisting educational resources available to study patients, socioeconomic factors, and emotional state.",2020,No statistical difference was detected in patient satisfaction scores between the intervention and control groups.,"['one-year period in 2018', 'Patients with Cerebral Aneurysms', '52 brain aneurysm patients (newly diagnosed or follow-up) presenting for their neurosurgery outpatient clinic visit', 'patients with a newly diagnosed complex disease']","['multimedia educational intervention', 'Health Literacy', 'educational intervention', 'multimedia-based patient education interventions']","['patient knowledge scores', 'patient health literacy and satisfaction', 'knowledge gain', 'patient satisfaction scores']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}, {'cui': 'C0751003', 'cui_str': 'Brain Aneurysm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",26.0,0.0575532,No statistical difference was detected in patient satisfaction scores between the intervention and control groups.,"[{'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA. Electronic address: agarwaln@upmc.edu.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Funahashi', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Tavis', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Jorge', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Rafey', 'Initials': 'R', 'LastName': 'Feroze', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hansberry', 'Affiliation': 'Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Gross', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Jankowitz', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Friedlander', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.099']
161,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
162,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma.
METHODS


It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months.
RESULTS


In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months.
CONCLUSION


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
163,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
164,32251932,Predictors of anxiety and depressive symptoms among teachers in Ghana: Evidence from a randomized controlled trial.,"RATIONALE


While teachers are heralded as key drivers of student learning outcomes, little attention has been paid to teachers' mental health, especially in less-developed countries such as Ghana. Professional background, workplace environment, and personal life stressors may threaten teachers' mental health and subsequent effectiveness in the classroom.
OBJECTIVES


The objectives of this study were to investigate 1) whether and how professional background, workplace environment, and personal life stressors predicted teachers' anxiety and depressive symptoms, and 2) whether participation in a professional development intervention predicted change in teachers' symptoms over the course of one school year in Ghana.
METHOD


We used multilevel models to examine predictors of depressive and anxiety symptoms among 444 kindergarten teachers (98% female; age range: 18-69) who participated in the Quality Preschool for Ghana (QP4G) Study. QP4G was a school-randomized control trial (n = 108 public schools; n = 132 private schools) evaluating a one-year teacher professional development intervention program implemented with and without parental-awareness meetings. Teacher depressive and anxiety symptoms were assessed at baseline before the intervention and at the end of the school year.
RESULTS


Poor workplace environment was associated with increased anxiety and depressive symptoms. Social support also predicted symptoms, with lack of support from students' parents and being new to the local community associated with more anxiety symptoms. Within teachers' personal lives, household food insecurity predicted more depressive symptoms. Finally, anxiety and depressive symptoms increased for all teachers over the school year. However, randomization to either intervention was linked to a significantly smaller increase in symptoms over the school year.
CONCLUSIONS


Results suggest that teachers' personal and professional lives are consequential for their mental health, and that professional development interventions that provide training and in-class coaching and parent engagement may benefit teachers' mental health.",2020,"Social support also predicted symptoms, with lack of support from students' parents and being new to the local community associated with more anxiety symptoms.","['teachers in Ghana', ""teachers' symptoms over the course of one school year in Ghana"", 'n = 108 public schools; n = 132 private schools) evaluating a', '444 kindergarten teachers (98% female; age range: 18-69) who participated in the Quality Preschool for Ghana (QP4G) Study']","['one-year teacher professional development intervention program implemented with and without parental-awareness meetings', 'QP4G']","['Teacher depressive and anxiety symptoms', 'anxiety and depressive symptoms', 'depressive symptoms']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0335008', 'cui_str': 'Pre-primary education teacher'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0812396,"Social support also predicted symptoms, with lack of support from students' parents and being new to the local community associated with more anxiety symptoms.","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Peele', 'Affiliation': 'Population Studies Center, University of Pennsylvania, 239 McNeil Building 3718 Locust Walk, Philadelphia, PA, 19104, USA. Electronic address: mopeele@sas.upenn.edu.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Graduate School of Education, University of Pennsylvania, 3700 Walnut Street, Philadelphia, PA, 9104, USA. Electronic address: wolfs@upenn.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112957']
165,31880964,Phase III Study of Adjuvant Ipilimumab (3 or 10 mg/kg) Versus High-Dose Interferon Alfa-2b for Resected High-Risk Melanoma: North American Intergroup E1609.,"PURPOSE


Phase III adjuvant trials have reported significant benefits in both relapse-free survival (RFS) and overall survival (OS) for high-dose interferon alfa (HDI) and ipilimumab at 10 mg/kg (ipi10). E1609 evaluated the safety and efficacy of ipilimumab at 3 mg/kg (ipi3) and ipi10 versus HDI.
PATIENTS AND METHODS


E1609 was a phase III trial in patients with resected cutaneous melanoma (American Joint Committee on Cancer 7th edition stage IIIB, IIIC, M1a, or M1b). It had 2 coprimary end points: OS and RFS. A 2-step hierarchic approach first evaluated ipi3 versus HDI followed by ipi10 versus HDI.
RESULTS


Between May 2011 and August 2014, 1,670 adult patients were centrally randomly assigned (1:1:1) to ipi3 (n = 523), HDI (n = 636), or ipi10 (n = 511). Treatment-related adverse events grade ≥ 3 occurred in 37% of patients receiving ipi3, 79% receiving HDI, and 58% receiving ipi10, with adverse events leading to treatment discontinuation in 35%, 20%, and 54%, respectively. Comparison of ipi3 versus HDI used an intent-to-treat analysis of concurrently randomly assigned patient cases (n = 1,051) and showed significant OS difference in favor of ipi3 (hazard ratio [HR], 0.78; 95.6% repeated CI, 0.61 to 0.99;  P  = .044; RFS: HR, 0.85; 99.4% CI, 0.66 to 1.09;  P  = .065). In the second step, for ipi10 versus HDI (n = 989), trends in favor of ipi10 did not achieve statistical significance. Salvage patterns after melanoma relapse showed significantly higher rates of ipilimumab and ipilimumab/anti-programmed death 1 use in the HDI arm versus ipi3 and ipi10 ( P  ≤ .001).
CONCLUSION


Adjuvant therapy with ipi3 benefits survival versus HDI; for the first time to our knowledge in melanoma adjuvant therapy, E1609 has demonstrated a significant improvement in OS against an active control regimen. The currently approved adjuvant ipilimumab dose (ipi10) was more toxic and not superior in efficacy to HDI.",2020,"Adjuvant therapy with ipi3 benefits survival versus HDI; for the first time to our knowledge in melanoma adjuvant therapy, E1609 has demonstrated a significant improvement in OS against an active control regimen.","['E1609 was a phase III trial in patients with resected cutaneous melanoma (American Joint Committee on Cancer 7th edition stage IIIB, IIIC, M1a, or M1b', 'Between May 2011 and August 2014, 1,670 adult patients']","['interferon alfa (HDI) and ipilimumab', 'Interferon Alfa-2b', 'Adjuvant Ipilimumab', 'HDI', 'ipilimumab']","['OS and RFS', 'safety and efficacy', 'relapse-free survival (RFS) and overall survival (OS']","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1670.0,0.211354,"Adjuvant therapy with ipi3 benefits survival versus HDI; for the first time to our knowledge in melanoma adjuvant therapy, E1609 has demonstrated a significant improvement in OS against an active control regimen.","[{'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'H. Lee Moffitt Comprehensive Cancer Center, Tampa, FL.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Uma N M', 'Initials': 'UNM', 'LastName': 'Rao', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Gary I', 'Initials': 'GI', 'LastName': 'Cohen', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, MD.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Angeles Clinic & Research Institute, Santa Monica, CA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'Hutchins', 'Affiliation': 'University of Arkansas, Little Rock, AR.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sosman', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Harriett M', 'Initials': 'HM', 'LastName': 'Kluger', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Eroglu', 'Affiliation': 'H. Lee Moffitt Comprehensive Cancer Center, Tampa, FL.'}, {'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Koon', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Lawrence', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Kari L', 'Initials': 'KL', 'LastName': 'Kendra', 'Affiliation': 'Ohio State University, Columbus, OH.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Minor', 'Affiliation': 'Sutter-California Pacific Medical Center, San Francisco, CA.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Albertini', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Flaherty', 'Affiliation': 'Wayne State University/Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Petrella', 'Affiliation': 'Odette Cancer Center, Toronto, Ontario, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Streicher', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Vernon K', 'Initials': 'VK', 'LastName': 'Sondak', 'Affiliation': 'H. Lee Moffitt Comprehensive Cancer Center, Tampa, FL.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01381']
166,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
167,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND


Monotherapy with immune checkpoint inhibitors has generally been unsuccessful in men with advanced prostate cancer. Preclinical data support the notion that cryotherapy may improve immune-mediated and anti-tumor responses. The objective of this study was to assess the safety and feasibility of whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation in men with oligometastatic hormone-sensitive prostate cancer.
METHODS


This single-institution, pilot trial recruited 12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016. Patients underwent whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab (6 doses). The primary clinical endpoints were the number of patients with a PSA level of <0.6 ng/mL at one year and the frequency of adverse events. Other outcome measures included progression-free survival and systemic therapy-free survival. Exploratory analyses included PD-L1 protein expression.
RESULTS


Forty two percent (5/12) of patients had a PSAs of <0.6 ng/mL at one year though only 2 of these patients had recovered their testosterone at this time point. Median progression-free survival was 14 months, and median systemic therapy-free survival was 17.5 months. PD-L1 expression was not detectable by IHC in patients with evaluable tissue. All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
CONCLUSIONS


Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
168,32306477,The association between anti-insulin aspart antibodies and the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in children and adolescents with type 1 diabetes.,"BACKGROUND


Fast-acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) ensuring ultrafast absorption and effect.
AIM


To compare the pharmacokinetics between faster aspart and IAsp, based on free or total IAsp measurement, and investigate the association between anti-IAsp antibodies and faster aspart and IAsp pharmacological properties in children and adolescents with type 1 diabetes (T1D).
METHODS


In a randomized, two-period crossover trial, 12 children, 16 adolescents, and 15 adults (6-11, 12-17, and 18-64 years) received 0.2 U/kg double-blindsingle-dose subcutaneous faster aspart or IAsp followed by a standardized liquid meal test.
RESULTS


Across age groups, the pharmacokinetic profile was left-shifted including greater early exposure for faster aspart vs IAsp irrespective of free or total IAsp assay. Onset of appearance occurred 2.4 to 5.0 minutes (free) or 1.8 to 3.0 minutes (total) earlier for faster aspart vs IAsp (P < .05). Treatment ratios (faster aspart/IAsp) for 0 to 30 minutes IAsp exposure were 1.60 to 2.11 and 1.62 to 1.96, respectively (children, free: P = .062; otherwise P < .05). The ratio of free/total IAsp for overall exposure (AUC IAsp,0-t  ) was negatively associated with anti-IAsp antibody level across age. Pooling with a previous similar trial showed no clear association between anti-IAsp antibodies and meal test 1- or 2-hour postprandial glucose increment independent of age and insulin treatment (R 2  ≤ .070; P ≥ .17).
CONCLUSIONS


In children and adolescents with T1D, faster aspart provides ultrafast pharmacokinetics irrespective of free or total IAsp assay. Elevated anti-IAsp antibodies are associated with higher total IAsp concentration, but do not impact faster aspart and IAsp glucose-lowering effect.",2020,"The ratio of free/total IAsp for overall exposure (AUC IAsp,0-t  ) was negatively associated with anti-IAsp antibody level across age.","['children and adolescents with type 1 diabetes', 'children and adolescents with type 1 diabetes (T1D', '12 children, 16 adolescents and 15 adults (6-11, 12-17 and 18-64 years) received']","['0.2 U/kg double-blind single-dose subcutaneous faster aspart or IAsp followed by a standardized liquid meal test', 'fast-acting insulin aspart', 'Fast-acting insulin aspart (faster aspart']",['Onset of appearance'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300561', 'cui_str': 'U/kg'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",12.0,0.0243365,"The ratio of free/total IAsp for overall exposure (AUC IAsp,0-t  ) was negatively associated with anti-IAsp antibody level across age.","[{'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'von dem Berge', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Line Quist', 'Initials': 'LQ', 'LastName': 'Bendtsen', 'Affiliation': 'Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mette Dahl', 'Initials': 'MD', 'LastName': 'Bendtsen', 'Affiliation': 'Biostatistics, Novo Nordisk A/S, Aalborg Ø, Denmark.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Rathor', 'Affiliation': 'Global Medical Affairs, Novo Nordisk Service Centre India Private Ltd., Bangalore, India.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Haahr', 'Affiliation': 'Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.'}]",Pediatric diabetes,['10.1111/pedi.13026']
169,32234584,Stigma interdependence among pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa.,"BACKGROUND


Stigma can exacerbate negative health outcomes in people living with HIV (PLWH). This longitudinal, cluster randomized controlled trial in rural Mpumalanga, South Africa, examined the interdependence of HIV-related stigma among pregnant couples living with HIV, and the potential impact of a lay health worker delivered intervention, Protect Your Family, on changes in stigma over time across couples, controlling for physical intimate partner violence (IPV), verbal IPV, gender, HIV knowledge, and months since HIV diagnosis. Using a form of the Actor-Partner Interdependence model, changes in stigma over time were also examined within each dyad of seroconcordant participants with HIV.
METHOD


Antenatal clinics were randomized to experimental or control conditions, and participants completed baseline antenatal and 12-month postpartum assessments. Both women and male partners participated in intervention sessions in gender concordant groups and couple or individual sessions.
RESULTS


Multilevel models (N = 1475) revealed stigma was related to condition and verbal intimate partner violence, but not time. Using an Actor-Partner Interdependence cross-lagged path model to examine within dyad changes in stigma for seroconcordant couples (n = 201), intervention condition participants' stigma levels were not interdependent over time. Women's 12-month stigma was related to their partners' stigma at baseline in the control condition, but not in the intervention condition.
DISCUSSION


Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners. The intervention may have promoted female empowerment to shape their own beliefs and attitudes towards what it means to be infected with HIV, and express their own agency in responding to how others treat them and they treat themselves.",2020,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","['rural Mpumalanga, South Africa', 'Both women and male partners', 'people living with HIV (PLWH', 'Antenatal clinics', 'pregnant couples living with HIV', 'pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa']",[],"['stigma was related to condition and verbal intimate partner violence', 'Stigma interdependence', 'postpartum stigma']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.0392253,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ramlagan', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Cristofari', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa; Department of Research & Innovation, University of Limpopo, Sovenga, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sifunda', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: djones@med.miami.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112940']
170,32243994,Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.,"OBJECTIVE


To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA).
DESIGN


100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost).
RESULTS


Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY).
CONCLUSIONS


From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT01535001.",2020,"RESULTS


Average costs were similar between groups (6,758 Euros vs. 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156).","['knee osteoarthritis (OA', '100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week', 'patients with knee osteoarthritis', 'patients with moderate-severe knee OA not eligible for TKR']","['individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice', 'written advice']","['Cost-effectiveness', '24-month cost-effectiveness', 'healthcare costs and transfer payments', 'Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'probability of cost-effectiveness', 'Effectiveness']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",100.0,0.0508179,"RESULTS


Average costs were similar between groups (6,758 Euros vs. 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156).","[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, 5230, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Region Zealand, Slagelse, 4200, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark. Electronic address: stskou@health.sdu.dk.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, 5230, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laursen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Simonsen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ibsen', 'Affiliation': 'I2minds, Aarhus, 8000, Denmark.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Larsen', 'Affiliation': 'VIVE - The Danish Centre of Applied Social Science, Copenhagen, 1150, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kjellberg', 'Affiliation': 'VIVE - The Danish Centre of Applied Social Science, Copenhagen, 1150, Denmark.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.03.009']
171,31899499,The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial.,"BACKGROUND


Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures.
OBJECTIVE


This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures.
DESIGN


This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups.
SETTING


This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers.
PARTICIPANTS


This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures.
INTERVENTION


A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise ≥3 times weekly. Controls received equal attention.
MEASUREMENTS


Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses.
RESULTS


There was a small effect of exercise on 5 times sit-to-stand test versus control (MD = -1.58 [95% CI = -3.09 to -0.07], intention-to-treat; MD = -1.49 [95% CI = -3.12 to 0.16], per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time.
LIMITATIONS


Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses.
CONCLUSIONS


Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.",2020,There was a small effect of exercise on five times sit-to-stand test versus control (MD:,"['patients after vertebral fractures', '141 women ≥65\xa0years with radiographically confirmed vertebral fractures', 'individuals with vertebral fractures', '5 Canadian and 2 Australian academic or community hospitals/centers', 'Older Women With Vertebral Fractures']","['control (MD', 'equal attention', 'home exercise versus control', 'exercise', 'physical therapist delivered exercise and behavioral counseling', 'Home Exercise', 'exercise or attentional control groups']","['Adherence', 'functional leg muscle strength', 'Functional performance, posture, quality of life, pain and behavior-change outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3853978'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",141.0,0.179121,There was a small effect of exercise on five times sit-to-stand test versus control (MD:,"[{'ForeName': 'Jenna C', 'Initials': 'JC', 'LastName': 'Gibbs', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada; and GERAS Centre for Aging Research, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Wark', 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, Victoria, Australia; and Bone and Mineral Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Samuel C', 'Initials': 'SC', 'LastName': 'Scherer', 'Affiliation': 'Department of Medicine, University of Melbourne; Royal Melbourne Hospital; and Broadmeadows Health Services, Northern Health, Melbourne, Australia.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Medicine, McMaster University; GERAS Centre for Aging Research, Hamilton Health Sciences; and Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mittmann', 'Affiliation': 'Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Laprade', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada; and Ontario Osteoporosis Strategy, Osteoporosis Canada, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ""Department of Medicine, University of Toronto; and Centre for Osteoporosis and Bone Health, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Grad Dip Physio, BAppSc (Physio), School of Primary and Allied Health Care, Peninsula Campus, Monash University, Frankston, Australia.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Toronto; and Osteoporosis Program and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bleakney', 'Affiliation': 'Department of Medical Imaging, University of Toronto; and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System.'}, {'ForeName': 'Maureen C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'Department of Family Practice, University of British Columbia; and Centre for Hip Health and Mobility, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Adachi', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'Lora M', 'Initials': 'LM', 'LastName': 'Giangregorio', 'Affiliation': 'Department of Kinesiology, University of Waterloo; and Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada; and KITE, Toronto Rehab-University Health Network, Toronto, Ontario, Canada.'}]",Physical therapy,['10.1093/ptj/pzz188']
172,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
173,31883418,Avelumab plus axitinib vs sunitinib for advanced renal cell carcinoma: Japanese subgroup analysis from JAVELIN Renal 101.,"The phase 3 JAVELIN Renal 101 trial of avelumab + axitinib vs sunitinib in patients with treatment-naive advanced renal cell carcinoma (RCC) demonstrated significantly improved progression-free survival (PFS) and higher objective response rate (ORR) with the combination vs sunitinib. Japanese patients enrolled in the study (N = 67) were randomized to receive avelumab + axitinib (N = 33) or sunitinib (N = 34); 67% vs 59% had PD-L1+ tumors (≥1% of immune cells) and 6%/64%/27% vs 6%/82%/12% had International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) favorable/intermediate/poor risk status. In patients who received avelumab + axitinib vs sunitinib, median PFS (95% confidence interval [CI]) was not estimable (8.1 months, not estimable) vs 11.2 months (1.6 months, not estimable) (hazard ratio [HR], 0.49; 95% CI, 0.152, 1.563) in patients with PD-L1+ tumors and 16.6 months (8.1 months, not estimable) vs 11.2 months (4.2 months, not estimable) (HR, 0.66; 95% CI, 0.296, 1.464) in patients irrespective of PD-L1 expression. Median overall survival (OS) has not been reached in either arm in patients with PD-L1+ tumors and irrespective of PD-L1 expression. ORR (95% CI) was 60.6% (42.1%, 77.1%) vs 17.6% (6.8%, 34.5%) in patients irrespective of PD-L1 expression. Common treatment-emergent adverse events (all grade; grade ≥3) in each arm were hand-foot syndrome (64%; 9% vs 71%; 9%), hypertension (55%; 30% vs 44%; 18%), hypothyroidism (55%; 0% vs 24%; 0%), dysgeusia (21%; 0% vs 56%; 0%) and platelet count decreased (3%; 0% vs 65%; 32%). Avelumab + axitinib was efficacious and tolerable in treatment-naive Japanese patients with advanced RCC, which is consistent with results in the overall population.",2020,Median OS has not been reached in either arm in patients with PD-L1+ tumors and irrespective of PD-L1 expression.,"['Japanese patients with advanced RCC', 'Japanese patients enrolled in the study (N=67', 'advanced renal cell carcinoma: Japanese subgroup analysis from JAVELIN Renal 101', 'patients with treatment-naive advanced renal cell carcinoma (RCC']","['Avelumab plus axitinib vs sunitinib', 'avelumab + axitinib', 'avelumab + axitinib vs sunitinib', 'sunitinib', 'Avelumab + axitinib']","['ORR', 'hypertension', 'Median OS', 'progression-free survival (PFS) and higher objective response rate (ORR', 'dysgeusia', 'platelet count', 'hypothyroidism']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}]",,0.141416,Median OS has not been reached in either arm in patients with PD-L1+ tumors and irrespective of PD-L1 expression.,"[{'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medicine, Niigata, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyake', 'Affiliation': 'Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Hatakeyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Hiro-Omi', 'Initials': 'HO', 'LastName': 'Kanayama', 'Affiliation': 'Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Numakura', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Takagi', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Urology, Faculty of Medicine, Yamagata University, Yamagata, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Eto', 'Affiliation': 'Department of Urology, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Obara', 'Affiliation': 'Department of Urology, Iwate Medical University School of Medicine, Morioka, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Kamei', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Umeyama', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Pfizer, Lombardia, Italy.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}]",Cancer science,['10.1111/cas.14294']
174,31729625,"Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045 trial.","BACKGROUND


The open-label, randomized, active-controlled KEYNOTE-045 study (NCT02256436) showed that second-line pembrolizumab significantly improved overall survival (OS) of patients with advanced/metastatic urothelial cancer (UC) that progressed after first-line platinum-containing chemotherapy, compared with standard chemotherapy (paclitaxel, docetaxel, or vinflunine). Pembrolizumab is approved for patients with bladder cancer in Japan.
PATIENTS AND METHODS


Analysis was performed in the subgroup of Japanese patients enrolled in the KEYNOTE-045 study. Coprimary end points were OS and progression-free survival (PFS). Objective response rate (ORR) and safety were secondary end points.
RESULTS


Fifty-two Japanese patients (pembrolizumab, n = 30; chemotherapy, n = 22) were followed up for a median of 26.1 months. Patients who received pembrolizumab compared with chemotherapy had a 19% lower risk for death (hazard ratio [HR] 0.81, 95% CI 0.44-1.50); after adjusting for baseline covariates, the HR for OS was 0.61 (95% CI 0.32-1.15). The 24-month OS rate was higher with pembrolizumab (26.9% vs 14.3%). PFS was 2.0 and 4.9 months for pembrolizumab and chemotherapy, respectively (HR 1.71, 95% CI 0.95-3.08). ORR was similar for pembrolizumab and chemotherapy (20.0% vs 18.2%); durability of response was higher with pembrolizumab: 67% and 33% of patients, respectively, maintained a response for > 12 months. Treatment-related adverse events, including grade 3-5 events, occurred less frequently with pembrolizumab.
CONCLUSIONS


Pembrolizumab provided durable antitumor activity in patients with locally advanced/metastatic UC that progressed after platinum-containing chemotherapy in the overall population and in the Japanese subgroup; safety profile was consistent with that previously observed for pembrolizumab.",2020,"Treatment-related adverse events, including grade 3-5 events, occurred less frequently with pembrolizumab.
","['patients with advanced/metastatic urothelial cancer (UC', 'patients with bladder cancer in Japan', 'Analysis was performed in the subgroup of Japanese patients enrolled in the KEYNOTE-045 study', 'patients with locally advanced/metastatic UC', 'recurrent, advanced urothelial cancer in Japanese patients', 'Fifty-two Japanese patients (pembrolizumab, n\u2009=\u200930; chemotherapy, n\u2009=\u200922']","['Pembrolizumab versus chemotherapy', 'pembrolizumab', 'chemotherapy', 'Pembrolizumab', 'standard chemotherapy (paclitaxel, docetaxel, or vinflunine', 'platinum-containing chemotherapy']","['Objective response rate (ORR) and safety', '24-month OS rate', 'ORR', 'durability of response', 'risk for death', 'overall survival (OS', 'durable antitumor activity', 'OS and progression-free survival (PFS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0672663', 'cui_str': 'vinflunine'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",52.0,0.280474,"Treatment-related adverse events, including grade 3-5 events, occurred less frequently with pembrolizumab.
","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'University of Tsukuba Hospital, 2 Chome-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan. nishiuro@md.tsukuba.ac.jp.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Yamaguchi University Hospital, 1 Chome-1-1 Minamikogush, Ube, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Sassa', 'Affiliation': 'Nagoya University Hospital, 65 Tsurumaicho, Showa Ward, Nagoya, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Osaka International Cancer Institute, 3 Chome-1-6 9 Otemae, Chuo Ward, Osaka, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Nara Medical University Hospital, 840 Shijocho, Kashihara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fukasawa', 'Affiliation': 'Chiba Cancer Center, 666-2 Nitonacho, Chiba, Japan.'}, {'ForeName': 'Minato', 'Initials': 'M', 'LastName': 'Yokoyama', 'Affiliation': 'Medical Hospital, Tokyo Medical and Dental University, 1 Chome-5-45 Yushima, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Enokida', 'Affiliation': 'Kagoshima University Hospital, 8-35-1 Sakuragaoka, Kagoshima, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Tokyo, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Imai', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shimamoto', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Tokyo, Japan.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Perini', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Frenkl', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bajorin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, USA.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'PSMAR-IMIM Research Institute, Carrer del Dr. Aiguader, 88, Barcelona, Spain.'}]",International journal of clinical oncology,['10.1007/s10147-019-01545-4']
175,32143061,Postpartum blood pressure trends are impacted by race and BMI.,"OBJECTIVE


Our objective was to evaluate postpartum blood pressure trends, and time to resolution of hypertension among women with hypertensive disorders of pregnancy, specifically focusing on impact of race and BMI on these trends.
METHODS


We performed a secondary analysis of a randomized trial that utilized a text-message based home blood pressure monitoring system. BPs for this study included both inpatient postpartum BPs as well as home BPs obtained from the text-based program. Women were followed from 12 h of delivery to 16 days postpartum. Outcomes were: (1) postpartum BP trend summaries from a linear mixed-effects regression model and (2) time to resolution of hypertension (defined as ≥ 48 h of BPs < 140/90) depicted using Kaplan Meier survival curves with hazard ratio estimates of association using Cox models.
RESULTS


Eighty-four women were included, of which 63% were black. Non-black women with a BMI < 35 kg/m 2  had steady decreases in systolic BP whereas other groups peaked around 6.5 days postpartum. BPs for women in the BMI < 35 group, regardless of race, remained in the normotensive range. Conversely, women with a BMI ≥ 35 had a systolic BP peak into the hypertensive range prior to declining. Diastolic BP peaked at an average of 8.5 days postpartum. Time to resolution of BPs differed by race and BMI groups (p = 0.012). Non-black women with a BMI < 35 had the shortest time to resolution and 81% of these women had resolution of hypertension. Only 49% of black women with a BMI < 35 had resolution of hypertension and approximately 40% of both black and non-black women with BMI ≥ 35 had resolution of hypertension.
CONCLUSION


We identified race and BMI to be determinants of postpartum BP trends and hypertension resolution. Further study is needed to determine if race and BMI targeted postpartum hypertension interventions may lead to faster blood pressure recovery and lower maternal morbidity postpartum.",2020,Time to resolution of BPs differed by race and BMI groups (p = 0.012). Non-black women with a BMI ,"['black women with a BMI', 'women with hypertensive disorders of pregnancy', 'Eighty-four women were included, of which 63% were black. Non-black women with a BMI', '≥\xa035', 'women in the BMI']",['text-message based home blood pressure monitoring system'],"['Time to resolution of BPs', 'Postpartum blood pressure trends', 'resolution of hypertension', 'systolic BP', 'systolic BP peak', 'Diastolic BP', 'postpartum BP trend summaries from a linear mixed-effects regression model and (2) time to resolution of hypertension']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1449681', 'cui_str': 'Blood Pressure Monitoring, Home'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",84.0,0.0634545,Time to resolution of BPs differed by race and BMI groups (p = 0.012). Non-black women with a BMI ,"[{'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Lopes Perdigao', 'Affiliation': 'Maternal and Child Health Research Center, Hospital of the University of Pennsylvania, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States. Electronic address: joana.lopesperdigao@uphs.upenn.edu.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Hirshberg', 'Affiliation': 'Maternal and Child Health Research Center, Hospital of the University of Pennsylvania, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': ""Center for Research on Reproduction and Women's Health, Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.""}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Maternal and Child Health Research Center, Hospital of the University of Pennsylvania, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics & Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine , Philadelphia, PA, United States.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Levine', 'Affiliation': 'Maternal and Child Health Research Center, Hospital of the University of Pennsylvania, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.02.006']
176,31088188,Blood Pressure Lowering With Nilvadipine in Patients With Mild-to-Moderate Alzheimer Disease Does Not Increase the Prevalence of Orthostatic Hypotension.,"Background Hypertension is common among patients with Alzheimer disease. Because this group has been excluded from hypertension trials, evidence regarding safety of treatment is lacking. This secondary analysis of a randomized controlled trial assessed whether antihypertensive treatment increases the prevalence of orthostatic hypotension (OH) in patients with Alzheimer disease. Methods and Results Four hundred seventy-seven patients with mild-to-moderate Alzheimer disease were randomized to the calcium-channel blocker nilvadipine 8 mg/day or placebo for 78 weeks. Presence of OH (blood pressure drop ≥20/≥10 mm Hg after 1 minute of standing) and OH-related adverse events (dizziness, syncope, falls, and fractures) was determined at 7 follow-up visits. Mean age of the study population was 72.2±8.2 years and mean Mini-Mental State Examination score was 20.4±3.8. Baseline blood pressure was 137.8±14.0/77.0±8.6 mm Hg. Grade I hypertension was present in 53.4% (n=255). After 13 weeks, blood pressure had fallen by -7.8/-3.9 mm Hg for nilvadipine and by -0.4/-0.8 mm Hg for placebo ( P<0.001). Across the 78-week intervention period, there was no difference between groups in the proportion of patients with OH at a study visit (odds ratio [95% CI]=1.1 [0.8-1.5], P=0.62), nor in the proportion of visits where a patient met criteria for OH, corrected for number of visits (7.7±13.8% versus 7.3±11.6%). OH-related adverse events were not more often reported in the intervention group compared with placebo. Results were similar for those with baseline hypertension. Conclusions This study suggests that initiation of a low dose of antihypertensive treatment does not significantly increase the risk of OH in patients with mild-to-moderate Alzheimer disease. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02017340.",2019,"Across the 78-week intervention period, there was no difference between groups in the proportion of patients with OH at a study visit (odds ratio","['patients with mild-to-moderate Alzheimer disease', 'Patients', 'Four hundred seventy-seven patients with mild-to-moderate Alzheimer disease', 'patients with Alzheimer disease']","['calcium-channel blocker nilvadipine 8\xa0mg/day or placebo', 'Nilvadipine', 'antihypertensive treatment', 'placebo']","['Baseline blood pressure', 'blood pressure', 'Grade I hypertension', 'Blood Pressure Lowering', 'Prevalence of Orthostatic Hypotension', 'OH-related adverse events', 'OH (blood pressure drop', 'risk of OH', 'mean Mini-Mental State Examination score', 'OH-related adverse events (dizziness, syncope, falls, and fractures', 'orthostatic hypotension (OH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0132512', 'cui_str': 'nilvadipine'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",477.0,0.569452,"Across the 78-week intervention period, there was no difference between groups in the proportion of patients with OH at a study visit (odds ratio","[{'ForeName': 'Rianne A A', 'Initials': 'RAA', 'LastName': 'de Heus', 'Affiliation': '1 Department of Geriatric Medicine Radboud University Medical Center Donders Institute for Brain Cognition and Behaviour Nijmegen The Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': '3 Department for Health Evidence Radboud University Medical Center Nijmegen The Netherlands.'}, {'ForeName': 'Angelina M M', 'Initials': 'AMM', 'LastName': 'Santoso', 'Affiliation': '1 Department of Geriatric Medicine Radboud University Medical Center Donders Institute for Brain Cognition and Behaviour Nijmegen The Netherlands.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': '1 Department of Geriatric Medicine Radboud University Medical Center Donders Institute for Brain Cognition and Behaviour Nijmegen The Netherlands.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Lawlor', 'Affiliation': ""4 Mercer's Institute for Research on Ageing St. James's Hospital Dublin Ireland.""}, {'ForeName': 'Jurgen A H R', 'Initials': 'JAHR', 'LastName': 'Claassen', 'Affiliation': '1 Department of Geriatric Medicine Radboud University Medical Center Donders Institute for Brain Cognition and Behaviour Nijmegen The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.011938']
177,30973970,"Investigation of the absolute bioavailability and human mass balance of navoximod, a novel IDO1 inhibitor.","AIMS


Navoximod (GDC-0919, NLG-919) is a small molecule inhibitor of indoleamine-2,3-dioxygenase 1 (IDO1), developed to treat the acquired immune tolerance associated with cancer. The primary objectives of this study were to assess navoximod's absolute bioavailability (aBA), determine the mass balance and routes of elimination of [ 14  C]-navoximod, and characterize navoximod's metabolite profile.
METHODS


A phase 1, open-label, two-part study was conducted in healthy volunteers. In Part 1 (aBA), subjects (n = 16) were randomized to receive oral (200 mg tablet) or intravenous (5 mg solution) navoximod in a crossover design with a 5-day washout. In Part 2 (mass balance), subjects (n = 8) were administered [ 14  C]-navoximod (200 mg/600 μCi) as an oral solution.
RESULTS


The aBA of navoximod was estimated to be 55.5%, with a geometric mean (%CV) plasma clearance and volume of distribution of 62.0 L/h (21.0%) and 1120 L (28.4%), respectively. Mean recovery of total radioactivity was 87.8%, with 80.4% detected in urine and the remainder (7.4%) in faeces. Navoximod was extensively metabolized, with unchanged navoximod representing 5.45% of the dose recovered in the urine and faeces. Glucuronidation was identified as the primary route of metabolism, with the major glucuronide metabolite, M28, accounting for 57.5% of the total drug-derived exposure and 59.7% of the administered dose recovered in urine.
CONCLUSIONS


Navoximod was well tolerated, quickly absorbed and showed moderate bioavailability, with minimal recovery of the dose as unchanged parent in the urine and faeces. Metabolism was identified as the primary route of clearance and navoximod glucuronide (M28) was the most abundant metabolite in circulation with all other metabolites accounting for <10% of drug-related exposure.",2019,"Navoximod was extensively metabolized, with unchanged navoximod representing 5.45% of the dose recovered in the urine and faeces.","['In Part 1 (aBA), subjects (n\xa0=\xa016', 'healthy volunteers']","['oral (200\xa0mg tablet) or intravenous (5\xa0mg solution) navoximod', 'Navoximod (GDC-0919, NLG-919']","['aBA of navoximod', 'geometric mean (%CV) plasma clearance and volume of distribution', 'moderate bioavailability', ""navoximod's absolute bioavailability (aBA), determine the mass balance and routes of elimination of [ 14  C]-navoximod, and characterize navoximod's metabolite profile"", 'Mean recovery of total radioactivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0302945', 'cui_str': 'Carbon-14'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034553', 'cui_str': 'Radioactive Disintegration'}]",16.0,0.0384553,"Navoximod was extensively metabolized, with unchanged navoximod representing 5.45% of the dose recovered in the urine and faeces.","[{'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Suchomel', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Yanez', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Yost', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Hoa', 'Initials': 'H', 'LastName': 'Le', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Siebers', 'Affiliation': 'Covance Clinical Research Unit, 3402 Kinsman Boulevard, Madison, WI, 53704, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Joas', 'Affiliation': 'Covance Clinical Research Unit, 3402 Kinsman Boulevard, Madison, WI, 53704, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Morley', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Royer-Joo', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pirzkall', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Salphati', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ware', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Kari M', 'Initials': 'KM', 'LastName': 'Morrissey', 'Affiliation': 'Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.13961']
178,32200051,What type of exercise is most effective for people with knee osteoarthritis and co-morbid obesity?: The TARGET randomized controlled trial.,"OBJECTIVE


Different exercise types may yield different outcomes in osteoarthritis (OA) subgroups. The objective was to directly compare effectiveness of two exercise programs for people with medial knee OA and co-morbid obesity.
DESIGN


We performed a participant- and assessor-blinded randomized controlled trial. 128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m 2  were recruited from the community. Interventions were home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise for 12 weeks. Primary outcomes were change in overall knee pain (numeric rating scale, range 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 12 weeks. Secondary outcomes included other pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength.
RESULTS


123 (96%) participants were retained. There was no evidence of a between-group difference in change in pain (mean difference 0.73 units (95% confidence intervals (0.05,1.50)) or function (2.80 units (-1.17,6.76)), with both groups reporting improvements. For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98). Although adverse events were minor, more NWB group participants reported ≥1 adverse event (26/66 (39%) vs 14/62 (23%), p = 0.04).
CONCLUSIONS


Both exercise types similarly improved primary outcomes of pain and function and can be recommended for people with knee OA and obesity. WB exercise may be preferred given fewer adverse events and potential additional benefits on some secondary outcomes.
REGISTRATION


Prospectively registered (Australian New Zealand Clinical Trials Registry #12617001013358, 14/7/2017).",2020,"For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98).","['123 (96', 'OA subgroups', 'people with knee OA and obesity', 'people with medial knee OA and co-morbid obesity', '128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m 2  were recruited from the community', 'people with knee osteoarthritis and co-morbid obesity']","['WB exercise', 'exercise programs', 'home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise']","['overall knee pain (numeric rating scale, range 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68', 'adverse events', 'quality-of-life', 'adverse event', 'pain and function', 'change in pain', 'pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength']","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing (finding)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",128.0,0.215058,"For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98).","[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: k.bennell@unimelb.edu.au.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: rachel.nelligan@unimelb.edu.au.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Kimp', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: alexander.kimp@unimelb.edu.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: sarah.schwartz@unimelb.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Electronic address: jessica.kasza@monash.edu.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Wrigley', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: timw@unimelb.edu.au.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Metcalf', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: b.metcalf@unimelb.edu.au.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'The University of Queensland, Centre for Clinical Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Sciences, QLD, Australia. Electronic address: p.hodges@uq.edu.au.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: ranash@unimelb.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.02.838']
179,31987653,Neurodevelopmental Outcomes of Neonates Randomized to Morphine or Methadone for Treatment of Neonatal Abstinence Syndrome.,"OBJECTIVE


To evaluate the effects of pharmacologic treatment of neonatal abstinence syndrome on neurodevelopmental outcome from a randomized, controlled trial.
STUDY DESIGN


Eight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on methadone or buprenorphine into a randomized trial of morphine vs methadone. Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale. At 18 months, 83 of 99 infants (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development-Third Edition and 77 of 99 (77.7%) with the Child Behavior Checklist (CBCL).
RESULTS


Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL. However in post hoc analyses, we found differences by atypical NICU Network Neurobehavioral Scale profile on the CBCL. Infants receiving adjunctive phenobarbital had lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems on the CBCL. In adjusted analyses, internalizing and total behavior problems were associated with use of phenobarbital (P = .03; P = .04), maternal psychological distress (measured by the Brief Symptom Inventory) (both P < .01), and infant medical problems (both P = .02). Externalizing problems were associated with maternal psychological distress (P < .01) and continued maternal substance use (P < .01).
CONCLUSIONS


Infants treated with either morphine or methadone had similar short-term and longer term neurobehavioral outcomes. Neurodevelopmental outcome may be related to the need for phenobarbital, overall health of the infant, and postnatal caregiving environment.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01958476.",2020,"RESULTS


Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL.","['Eight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on', 'Neonatal Abstinence Syndrome', 'Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale', 'neonatal abstinence syndrome']","['morphine vs methadone', 'morphine or methadone', 'methadone or buprenorphine', 'Morphine or Methadone', 'pharmacologic treatment', 'adjunctive phenobarbital']","['lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems', 'infant medical problems', 'Externalizing problems', 'NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL', 'need for phenobarbital, overall health of the infant, and postnatal caregiving environment', 'Child Behavior Checklist (CBCL', 'continued maternal substance use', 'atypical NICU Network Neurobehavioral Scale profile', 'similar short-term and longer term neurobehavioral outcomes', 'maternal psychological distress', 'internalizing and total behavior problems']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0222045'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",116.0,0.114946,"RESULTS


Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL.","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Czynski', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI. Electronic address: ACzynski@wihri.org.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA; Tufts Clinical and Translational Science Institute, Boston, MA; The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Dansereau', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Engelhardt', 'Affiliation': ""Department of Pediatrics, Monroe Carell Jr Children's Hospital at Vanderbilt, Nashville, TN.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marro', 'Affiliation': 'Department of Pediatrics, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'Department of Pediatrics, Jacksonville-University of Florida Health, Jacksonville, FL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Shenberger', 'Affiliation': 'Department of Pediatrics, Baystate Medical Center, Springfield, MA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, MA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Oliveira', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Lester', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI; Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.018']
180,32307124,"Changes in Firearm and Medication Storage Practices in Homes of Youths at Risk for Suicide: Results of the SAFETY Study, a Clustered, Emergency Department-Based, Multisite, Stepped-Wedge Trial.","STUDY OBJECTIVE


We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
METHODS


We used a stepped-wedge clustered design rolled out at 4 hospital sites to assess primary preregistered outcomes (self-reported storage changes caregivers made to household firearms and medications), assessed by survey 2 weeks after the ED visit. Three logistic models provided estimates of the intervention effect: an unadjusted model, a model with hospital-level fixed effects, and a model that further adjusts for time.
RESULTS


Of the 575 caregiver participants, 208 were firearm owners (123 in usual care, 85 in the intervention). Baseline (pre-ED visit) characteristics did not differ between usual care and intervention phases. During the 2-year study period, twice as many caregivers whose child visited the ED after (compared with before) a hospital adopted the intervention improved firearm storage and 3 times as many improved medication storage (odds ratio [OR]=2.1 [95% confidence interval {CI} 1.0 to ∞] and OR=3.0 [95% CI 2.2 to ∞], respectively). After adjusting for time, the intervention effect for medications persisted (OR=2.0 [95% CI 1.0 to ∞]); the effect on firearms did not (OR=0.7 [95% CI 0.1 to ∞]).
CONCLUSION


To our knowledge, this study is the first controlled trial to estimate the effectiveness of an intervention on firearm and medication storage in homes of youths at elevated risk of suicide. We found evidence that caregivers' medication storage improved after their child's ED visit, with evidence suggestive of improvement for firearm storage.",2020,"We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
","[""caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern"", 'Homes of Youths at Risk for Suicide', 'homes of youths at elevated risk of suicide', 'Of the 575 caregiver participants, 208 were firearm owners (123 in usual care, 85 in the intervention']",['counseling intervention'],['firearm storage and 3 times as many improved medication storage'],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",575.0,0.122917,"We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Northeastern University, Boston, MA; Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA. Electronic address: ma.miller@northeastern.edu.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Salhi', 'Affiliation': 'Northeastern University, Boston, MA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barber', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Azrael', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beatriz', 'Affiliation': 'Northeastern University, Boston, MA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Berrigan', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Brandspigel', 'Affiliation': 'Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Betz', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Runyan', 'Affiliation': 'Colorado School of Public Health, Aurora, CO.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.02.007']
181,32300812,"Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],['High Diet-Induced Thermogenesis'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.0175443,,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa208']
182,32300831,C-reactive protein as marker of post-operative analgesic quality after primary total knee arthroplasty.,"OBJECTIVE


To study the correlation between the level of C-reactive protein (CRP) and the severity of pain in the post-operative period with primary total knee arthroplasty and to conduct a comparative assessment of these indicators with various methods of pain relief. The primary hypothesis of the investigation was that post-operative CRP level is likely to be correlated with the severity of post-operative pain after total knee arthroplasty. The secondary points were the evaluation of CRP and pain syndrome in the groups, as well as the identification of the correlation between the level of CRP and the method of analgesia.
MATERIALS AND METHODS


Peri-operative levels of CRP and pain syndrome (10-point visual analogue scale) studied 160 patients with grade III gonarthrosis who have underwent primary total knee arthroplasty under conditions of subarachnoid anaesthesia in the period from years 2017 to 2019. Depending on the method of post-operative analgesia, patients were divided into five groups: group 1 had only systemic multimodal analgesia (SMA, n = 56), group 2 were treated with the epidural analgesia (EDA, n = 20), group 3 had local high-volume infiltration anaesthesia (LHVIA, n = 20), group 4 were getting LHVIA with a wound catheter (LHVIAc, n = 48), and group 5 had a single blockade of the femoral nerve (FNB, n = 16).
RESULTS


A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = 160, Kendall coefficient τ = 0.230, p = 0,000) and on the first post-operative day (n = 160, τ = 0.21, p = 0.001). The increase in CRP (the difference between pre-operative and post-operative CRP levels) also was positively correlated with the severity of pain in the post-operative period (n = 160, τ = 0.257, p = 0.000 and τ = 0.187, p = 0.001, respectively). CRP level significantly has increased in the post-operative period (p = 0,000). The lowest CRP indicators in the first post-operative day were recorded during the infiltrative anaesthesia (3rd and 4th groups);, the highest were during the administration of SMA group (1st group).
CONCLUSION


The results confirm the correlation between the level of CRP and the severity of pain syndrome in the early post-operative period after total knee arthroplasty, its dependence on the method of analgesia, and allow to use it as a criterion for evaluating of the effectiveness of analgesia.",2020,A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = ,"['Peri-operative levels of CRP and pain syndrome (10-point visual analogue scale) studied 160 patients with grade III gonarthrosis who have underwent primary total knee arthroplasty under conditions of subarachnoid anaesthesia in the period from years 2017 to 2019', 'primary total knee arthroplasty']","['C-reactive protein (CRP', 'SMA', 'systemic multimodal analgesia (SMA, n\u2009=\u200956), group 2 were treated with the epidural analgesia (EDA, n\u2009=\u200920), group 3 had local high-volume infiltration anaesthesia (LHVIA, n\u2009=\u200920), group 4 were getting LHVIA with a wound catheter (LHVIAc, n\u2009=\u200948), and group 5 had a single blockade of the femoral nerve (FNB, n\u2009=\u200916']","['level of CRP and the severity of pain syndrome', 'severity of pain', 'evaluation of CRP and pain syndrome', 'CRP', 'lowest CRP indicators', 'CRP level', 'pain relief']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0162359', 'cui_str': 'Hypohidrotic X-linked ectodermal dysplasia'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",160.0,0.0212272,A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = ,"[{'ForeName': 'Dmitry A', 'Initials': 'DA', 'LastName': 'Tarasov', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Alexey V', 'Initials': 'AV', 'LastName': 'Lychagin', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Andrei G', 'Initials': 'AG', 'LastName': 'Yavorovkiy', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Lipina', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia. marina.lipina@icloud.com.'}, {'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Tarasova', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}]",International orthopaedics,['10.1007/s00264-020-04551-8']
183,32301137,Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data.,"BACKGROUND


Relamorelin, a pentapeptide ghrelin receptor agonist, accelerated gastric emptying significantly and improved symptoms in adults with diabetic gastroparesis in phase 2 trials.
AIM


To assess the safety and tolerability of relamorelin across phase 2 trials.
METHODS


Safety assessments in patients aged 18-75 years (weight, adverse events [AEs] and laboratory tests) from two randomised, double-blind phase 2 trials (NCT01571297, NCT02357420; results published previously) were reviewed descriptively. Analysis of covariance assessed treatment effect on glycated haemoglobin (HbA1c) and blood glucose post hoc. Phase 2a and 2b trial durations were, respectively, 4 weeks (relamorelin 10 µg once or twice daily [b.d.] or placebo b.d.) and 12 weeks (relamorelin 10, 30 or 100 µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins.
RESULTS


Among 204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes. Proportions of patients reporting serious AEs were similar across treatment groups, as were those with ≥1 treatment-emergent AE (TEAE). TEAE-related discontinuations were proportionally higher in relamorelin groups than placebo. Of 12 serious TEAEs in phase 2a, none occurred in >1 patient. In phase 2b, five serious TEAEs were reported in >1 patient, and one (100 µg) died (urosepsis), all unrelated to relamorelin. In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
CONCLUSIONS


Relamorelin showed acceptable safety and tolerability in phase 2 trials. Relamorelin may elevate blood glucose: this should be managed proactively in relamorelin-treated patients.",2020,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
","['adults with diabetic gastroparesis', '204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes', 'adults with diabetic gastroparesis in phase\xa02 trials', 'patients aged 18-75\xa0years (weight, adverse events [AEs] and laboratory tests']","['Relamorelin', 'placebo', 'relamorelin', 'placebo b.d.) and 12\xa0weeks (relamorelin 10, 30 or 100\xa0µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins']","['Overall safety', 'glycated haemoglobin (HbA1c) and blood glucose post hoc', 'TEAE-related discontinuations', 'blood glucose', 'safety and tolerability', 'acceptable safety and tolerability', 'HbA1c and fasting blood glucose levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis with diabetes mellitus'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]","[{'cui': 'C4045486', 'cui_str': 'relamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.432022,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McCallum', 'Affiliation': 'Division of Gastroenterology, Texas Tech University Health Sciences Center, El Paso, TX, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Tourkodimitris', 'Affiliation': 'Biostatistics, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kemps', 'Affiliation': 'Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Chemistry, Manufacturing and Controls, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Bertelsen', 'Affiliation': 'Clinical Pharmacology, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Iacob', 'Affiliation': 'Medical Safety, Allergan plc, Madison, NJ, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15711']
184,32299114,Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial.,"BACKGROUND : Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones. METHODS : This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones. The primary end point was complete stone removal in a single session. The secondary end points included: overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost. RESULTS:  171 patients with large CBD stones were included in the analysis. The rate of single-session complete stone removal was significantly higher in the EPLBD-alone group than in the EST group (90.7 % vs. 78.8 %;  P  = 0.04). Lithotripsy use was significantly less frequent in the EPLBD group than in the EST group (30.2 % vs. 48.2 %;  P  = 0.02). The rates of early adverse events were comparable between the two groups: rates of overall adverse events were 9.3 % vs. 9.4 % and of pancreatitis were 4.7 % vs. 5.9 % in the EPLBD and EST groups, respectively. The procedure costs were $1442 vs. $1661 in the EPLBD and EST groups, respectively ( P  = 0.12). CONCLUSION : EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.",2020,"EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.","['171 patients with large CBD stones', '19 Japanese institutions', 'bile duct stones']","['EST', 'endoscopic sphincterotomy (EST), EPLBD alone without EST', 'EPLBD alone versus EST', 'Endoscopic papillary large balloon dilation (EPLBD', 'EPLBD', 'endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy']","['overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost', 'adverse events', 'pancreatitis', 'rates of overall adverse events', 'procedure costs', 'Lithotripsy use', 'rate of complete stone removal', 'efficacy and safety', 'complete stone removal', 'rates of early adverse events', 'rate of single-session complete stone removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009438', 'cui_str': 'Common bile duct calculus'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0267869', 'cui_str': 'Calculus of bile duct'}]","[{'cui': 'C0085263', 'cui_str': 'Endoscopic Sphincterotomy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0177047', 'cui_str': 'Sphincterotomy (bladder)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]",171.0,0.104249,"EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kogure', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kawahata', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Mukai', 'Affiliation': 'Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Iwashita', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Tesshin', 'Initials': 'T', 'LastName': 'Ban', 'Affiliation': 'Department of Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sasahira', 'Affiliation': 'Department of Gastroenterology, Tokyo Takanawa Hospital of Japan Community Health-care Organization, Tokyo, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Division of Gastroenterology, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Togawa', 'Affiliation': 'Department of Gastroenterology, Kanto Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Hironari', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Okabe', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University of Medicine, Kurume, Japan.'}, {'ForeName': 'Saburo', 'Initials': 'S', 'LastName': 'Matsubara', 'Affiliation': 'Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yagioka', 'Affiliation': 'Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yousuke', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isayama', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Endoscopy,['10.1055/a-1145-3377']
185,32302261,The Effects of Different Sources of Stuttering Disclosure on the Perceptions of a Child Who Stutters.,"Purpose This study measured between-group differences in perceived speech skills and personality characteristics of a 12-year-old boy who stutters as a function of a factual stuttering disclosure statement, delivered by the boy who stutters, his ""mother,"" or his ""teacher."" Method Two hundred seventeen college-aged adults were randomly assigned to one of four groups, including a control group (no stuttering disclosure) and three experimental groups (child disclosure, mother disclosure, and teacher disclosure). Participants in the control condition viewed a brief video of a 12-year-old boy who stutters. For the experimental conditions, participants viewed a brief factual stuttering disclosure video (delivered by the child, mother, or teacher), followed by the same minute-long video of a boy who stutters used in the control condition. Following the videos, participants completed surveys relative to their perception of the boy's speech skills and personality characteristics. Results Results support previous research citing benefits of stuttering disclosure. Significant between-group differences in both perceived speech skills and personality characteristics were observed when stuttering was disclosed by not only the child who stutters but also his teacher. When stuttering was disclosed by the mother, limited positive attitudinal differences were observed in speech skills; as a matter of fact, a number of personality characteristics were perceived more negatively as a function of stuttering disclosure by the mother. Conclusions While results were generally most positive when the boy disclosed his own stuttering, data from this study support the efficacy of verbal stuttering disclosure provided by a teacher as a means of improving perceptions associated with stuttering. Accordingly, data support the notion that children who stutter will experience an improved quality of life when taught effective self-disclosure strategies by both parents and professionals, and that professionals (but not necessarily parents) can effectively disclose their clients' stuttering during this mentorship and self-advocacy process.",2020,Significant between-group differences in both perceived speech skills and personality characteristics were observed when stuttering was disclosed by not only the child who stutters but also his teacher.,"['12-year-old boy who stutters as a function of a factual stuttering disclosure statement, delivered by the boy who stutters, his ""mother,"" or his ""teacher', 'Participants in the control condition viewed a brief video of a 12-year-old boy who stutters', 'Method Two hundred seventeen college-aged adults']","['control group (no stuttering disclosure) and three experimental groups (child disclosure, mother disclosure, and teacher disclosure']","['speech skills', 'quality of life', 'perceived speech skills and personality characteristics']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}]",217.0,0.026744,Significant between-group differences in both perceived speech skills and personality characteristics were observed when stuttering was disclosed by not only the child who stutters but also his teacher.,"[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Snyder', 'Affiliation': 'Department of Communication Sciences & Disorders, The University of Mississippi, University.'}, {'ForeName': 'Molly Grace', 'Initials': 'MG', 'LastName': 'Williams', 'Affiliation': 'Department of Communication Sciences & Disorders, The University of Mississippi, University.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Adams', 'Affiliation': 'School of Behavioral and Brain Sciences, The University of Texas at Dallas, Richardson.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Blanchet', 'Affiliation': 'Department of Communication Sciences and Disorders, Baylor University, Waco, TX.'}]","Language, speech, and hearing services in schools",['10.1044/2020_LSHSS-19-00059']
186,32304001,Evaluation of adjunctive efficacy of diode laser in the treatment of peri-implant mucositis: a randomized clinical trial.,"Peri-implant disease may affect survival of dental implants. The aim of the study is to analyze the effectiveness of diode laser as a supportive modality to the non-surgical conventional treatment of peri-implant mucositis (PiM) and initial peri-implantitis (PI). Twenty-three patients with single implants suffering from PiM or initial PI were selected and randomly divided into two groups; control group (CG) received non-surgical conventional treatment, and test group (TG) received non-surgical conventional treatment and diode laser application with wavelength of 980 nm. Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1). The average of PPD value for TG was 4.04 ± 0.54 mm at T0 and it was 2.98 ± 0.70 mm at T1. In the CG, PPD average was 3.8 ± 1.24 mm at T0 and was 3.54 ± 0.35 mm at T1. In TG, the BOP was positive in 44 sites at T0 and in 6 sites at T1. In CG, the BOP was positively observed in 52 sites at T0 and in 28 sites at T1. The 980-nm diode laser may be considered an adjunct to the conventional non-surgical treatments of PiM and initial PI.",2020,Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1).,"['peri-implant mucositis (PiM) and initial peri-implantitis (PI', 'peri-implant mucositis', 'Twenty-three patients with single implants suffering from PiM or initial PI']","['diode laser', 'control group (CG) received non-surgical conventional treatment, and test group (TG) received non-surgical conventional treatment and diode laser application with wavelength of 980\xa0nm']","['average of PPD value for TG', 'BOP', 'Probing pocket depth (PPD) and bleeding on probing (BOP']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",23.0,0.0224006,Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1).,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tenore', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Montori', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mohsen', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy. ahmed.mohsen@uniroma1.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mattarelli', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Gaspare', 'Initials': 'G', 'LastName': 'Palaia', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Romeo', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}]",Lasers in medical science,['10.1007/s10103-020-03009-y']
187,32304151,"Promoting physical activity through walking to treat childhood obesity, mainly for mild to moderate obesity.","BACKGROUND


There are no randomized controlled trials examining the effect of walking on childhood obesity.
METHODS


A randomized controlled trial was conducted between August 2014 and April 2015 in Japan. Elementary school children aged 6 to 12 years with a percentage overweight (%OW) of ≥20% were recruited. One hundred and ninety children wanted to participate in the program, and all were accepted. After viewing a video that promoted physical activity through walking, participants were randomly assigned to three groups: walking (≥10 000 steps on school holidays), limiting screen time (<90 min on weekdays and <150 min on school holidays), and a control group (no intervention). The primary outcome was a decrease in %OW after 3 months' intervention. Per protocol analysis was performed using 156 participants who fulfilled the inclusion criteria of a %OW ≥20%.
RESULTS


The mean %OW was 35 ± 7% before intervention. The mean reduction in %OW after intervention in the walking (n = 59), limiting ST (n = 46), and control (n = 51) groups were -4.06 ± 4.84, -1.97 ± 4.62, and -1.81 ± 3.64 percentage points, respectively. Reduction in %OW was significantly larger in the walking group than in the control group: adjusted mean difference, -2.18 percentage points (95% confidence interval, -3.85 to -0.52), P = 0.002. The intervention in children also had favorable effects on the lifestyles of their parents. The intention-to-treat analysis of all 190 participants showed comparable results.
CONCLUSION


Promoting physical activity through walking on school holidays may be an additional strategy for treating elementary school children with obesity.",2020,"Reduction in %OW was significantly larger in the walking group (adjusted mean difference, -2.18 percentage points [95% confidence interval, -3.85 to -0.52], P = 0.002) than in the control group.","['One hundred ninety children wanted to participate in the program, and all were accepted to participate in the intervention program', 'Elementary school children aged 6 to 12 years with a percent overweight (%OW) of ≥20% were recruited', 'August 2014 and April 2015 in Japan', 'elementary school children with obesity', '156 participants who fulfilled the inclusion criteria of a %OW ≥20']","['walking (≥10,000 steps on school holidays), limiting screen time (ST) (<90 min on weekdays and <150 min on school holidays), and a control group (no intervention']","['mean %OW', 'decrease in %OW']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019843', 'cui_str': 'Holidays'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",190.0,0.055114,"Reduction in %OW was significantly larger in the walking group (adjusted mean difference, -2.18 percentage points [95% confidence interval, -3.85 to -0.52], P = 0.002) than in the control group.","[{'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yoshinaga', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Pediatrics, Japan Community Health Care Organization Takaoka Fushiki Hospital, Takaoka, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Aoki', 'Affiliation': 'Aoki Internal Cardiology and Pediatric Clinic, Fukuoka, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Epidemiology and Biostatistics, Kagawa Nutrition University, Sakado, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Faculty of Nursing, Japanese Red Cross Hokkaido College of Nursing, Kitami, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hamajima', 'Affiliation': ""Department of Endocrinology and Metabolism, Aichi Children's Health and Medical Center, Ohbu, Japan.""}, {'ForeName': 'Masakuni', 'Initials': 'M', 'LastName': 'Tokuda', 'Affiliation': 'Tokuda Kodomo Clinic, Amagasaki, Japan.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Child Health, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Horigome', 'Affiliation': 'Department of Child Health, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'National Institute of Public Health, Wako, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Nagashima', 'Affiliation': 'Aichi Saiseikai Rehabilitation Hospital, Nagoya, Japan.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14253']
188,32304159,Evaluation of an implementation project: The exercise physiology in aged care program.,"AIM


It is important for older adults to maintain the ability to be physically active, and to experience the benefits that physical activity brings. This study evaluates a 12-week Accredited Exercise Physiologist-led exercise program for vulnerable older adults living with dementia, delivered in a residential aged care facility in South Australia. The value of the program was also evaluated from the perspective of partners-in-care (family members and care staff).
METHODS


Participants (n = 59) were randomized to either an intervention or control group, based on their functional and cognitive status. Physical function, cognitive function and habitual physical activity were assessed at baseline and post-intervention. In total, 51 family members and 44 care staff completed surveys or participated to understand their perspectives of residents' capacity to exercise, as well as their perceptions of the impact of the program.
RESULTS


Repeated measures ANOVA identified evidence for maintenance of physical function (timed-up-and-go [ɳ 2  = 0.19], handgrip strength [ɳ 2  = 0.13]); however, there were no differences for objectively measured habitual activity or cognitive function. Evidence for a dose effect was demonstrated for the 2-min walk and timed-up-and-go associated with the number of individual sessions attended by a participant. Partners-in-care perceived greater improvement compared with deterioration across all measured factors [(P < 0.01, partial eta 2  (ɳ 2  ) =0.19] ranged from 0.35 to 0.78) post-intervention. Perceptions and expectations of who could benefit from participation were changed (P < 0.05) and indicated that all but the most severely declined residents would be likely to benefit.
CONCLUSIONS


Data supporting the maintenance for some physical functions suggest that this type of program should be considered for older adults living with dementia in residential aged care facilities. Geriatr Gerontol Int 2020; ••: ••-••.",2020,Evidence for a dose effect was demonstrated for the 2-min walk and timed-up-and-go associated with the number of individual sessions attended by a participant.,"['Participants (n = 59', 'vulnerable older adults living with dementia, delivered in a residential aged care facility in South Australia', 'older adults', 'In total, 51 family members and 44 care staff completed surveys or participated', 'older adults living with dementia in residential aged care facilities', 'aged care program']",['Exercise Physiologist-led exercise program'],"['Physical function, cognitive function and habitual physical activity', 'handgrip strength', 'habitual activity or cognitive function', 'maintenance of physical function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",59.0,0.0232159,Evidence for a dose effect was demonstrated for the 2-min walk and timed-up-and-go associated with the number of individual sessions attended by a participant.,"[{'ForeName': 'Gaynor', 'Initials': 'G', 'LastName': 'Parfitt', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Allied Health and Human Performance, Adelaide, South Australia, Australia.'}, {'ForeName': 'Dannielle', 'Initials': 'D', 'LastName': 'Post', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Allied Health and Human Performance, Adelaide, South Australia, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Penington', 'Affiliation': 'Helping Hand Organisation, North Adelaide, South Australia, Australia.'}, {'ForeName': 'Kade', 'Initials': 'K', 'LastName': 'Davison', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Allied Health and Human Performance, Adelaide, South Australia, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Corlis', 'Affiliation': 'Helping Hand Organisation, North Adelaide, South Australia, Australia.'}]",Geriatrics & gerontology international,['10.1111/ggi.13923']
189,30980733,Dynamics of circulating vascular endothelial growth factor-A predict benefit from antiangiogenic cediranib in metastatic or recurrent cervical cancer patients.,"AIMS


There is a need for predictive and surrogate response biomarkers to support treatment with antiangiogenic vascular endothelial growth factor (VEGF) inhibitors. We aimed to identify a minimally-invasive biomarker predicting benefit from cediranib pretreatment or early during treatment in patients with recurrent or metastatic cervical cancer.
METHODS


Blood samples were collected before treatment, during treatment and upon disease progression where appropriate from patients enrolled in CIRCCa, a randomised phase II trial of carboplatin and paclitaxel with or without cediranib. Plasma concentrations of VEGF-A, VEGF-receptor 2, Ang1 and Tie2 were measured using multiplex enzyme-linked immunosorbent assay. Pretreatment and temporal changes of the biomarkers were investigated using proportional hazard regression and unsupervised clustering analysis.
RESULTS


Samples (n = 556) from 52 patients were analysed. VEGF-receptor 2 (P = .0006) and Tie2 (P = .04) were downregulated following cediranib, while VEGF-A (P = .0025) was upregulated. High Eastern Cooperative Oncology Group performance status (P = .02, hazard ratio [HR] = 2.15, 95% confidence interval [CI] 1.13-4.09) and low pretreatment Tie2 concentrations (P = .003, HR = 0.57, 95%CI 0.39-0.83) were independent prognostic factors associated with reduced progression-free survival. Two patterns of changes in VEGF-A following cediranib were identified. Patients with elevated VEGF-A in the first 3 treatment cycles, regardless of magnitude, had reduced progression-free survival in the placebo arm but improved survival with the addition of cediranib (P = .019, HR = 0.13, 95% CI 0.02-0.71).
CONCLUSION


Patterns of early elevation in plasma VEGF-A should be studied further as a potential biomarker to predict treatment benefit from cediranib.",2019,"VEGF-receptor 2 (P = .0006) and Tie2 (P = .04) were downregulated following cediranib, while VEGF-A (P = .0025) was upregulated.","['patients with recurrent or metastatic cervical cancer', 'metastatic or recurrent cervical cancer patients', 'Samples (n\xa0', '556) from 52 patients were analysed']","['antiangiogenic cediranib', 'cediranib', 'carboplatin and paclitaxel with or without cediranib']","['survival', 'Plasma concentrations of VEGF-A, VEGF-receptor 2', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}]","[{'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",556.0,0.258577,"VEGF-receptor 2 (P = .0006) and Tie2 (P = .04) were downregulated following cediranib, while VEGF-A (P = .0025) was upregulated.","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Clinical & Experimental Pharmacology Group, Cancer Research UK Manchester Institute and Manchester Centre for Cancer Biomarker Sciences, University of Manchester, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Tugwood', 'Affiliation': 'Clinical & Experimental Pharmacology Group, Cancer Research UK Manchester Institute and Manchester Centre for Cancer Biomarker Sciences, University of Manchester, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Simpson', 'Affiliation': 'Clinical & Experimental Pharmacology Group, Cancer Research UK Manchester Institute and Manchester Centre for Cancer Biomarker Sciences, University of Manchester, UK.'}, {'ForeName': 'Gordon C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Christie Hospital NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Symonds', 'Affiliation': 'Department of Cancer Studies, University of Leicester, Leicester, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'Christie Hospital NHS Trust, Manchester, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Carty', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McCartney', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Rai', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dive', 'Affiliation': 'Clinical & Experimental Pharmacology Group, Cancer Research UK Manchester Institute and Manchester Centre for Cancer Biomarker Sciences, University of Manchester, UK.'}, {'ForeName': 'Catharine', 'Initials': 'C', 'LastName': 'West', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Christie Hospital NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.13965']
190,32171508,Effects of kefir or milk supplementation on zonulin in overweight subjects.,"Increased intestinal permeability has been shown to be involved in several diseases associated with low-grade chronic inflammation, including obesity and metabolic syndrome. In the last decade, growing evidence shows the beneficial effects of probiotic-containing food supplementation on these conditions. In this crossover intervention study on 28 asymptomatic overweight adults, we tested the effects of a 3-wk kefir supplementation compared with a 3-wk milk supplementation on serum zonulin levels. The effects on serum glucose, triacylglycerols, low-density lipoproteins, high-density lipoproteins, total cholesterol, markers of inflammation (C-reactive protein and adiponectin), anthropometric variables, mood, and appetite were also determined. Kefir supplementation resulted in a greater improvement of serum zonulin levels (F = 6.812, η 2  = 0.275), whereas a significant yet similar improvement in lipid profile and serum glucose levels was found in both supplementations. Positive mood was slightly but significantly enhanced with kefir supplementation, and reduced with milk supplementation. The C-reactive protein, adiponectin, and appetite were unaffected. In conclusion, supplementation with both dairy products had health beneficial effects, but only kefir showed an effect on the intestinal barrier dysfunction marker.",2020,"Kefir supplementation resulted in a greater improvement of serum zonulin levels (F = 6.812, η 2  = 0.275), whereas a significant yet similar improvement in lipid profile and serum glucose levels was found in both supplementations.","['28 asymptomatic overweight adults', 'overweight subjects']","['3-wk kefir supplementation', '3-wk milk supplementation', 'kefir or milk supplementation', 'probiotic-containing food supplementation', 'Kefir supplementation']","['C-reactive protein, adiponectin, and appetite', 'Positive mood', 'lipid profile and serum glucose levels', 'serum zonulin levels', 'intestinal barrier dysfunction marker', 'serum glucose, triacylglycerols, low-density lipoproteins, high-density lipoproteins, total cholesterol, markers of inflammation (C-reactive protein and adiponectin), anthropometric variables, mood, and appetite']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0524649', 'cui_str': 'Kefir'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",28.0,0.0269953,"Kefir supplementation resulted in a greater improvement of serum zonulin levels (F = 6.812, η 2  = 0.275), whereas a significant yet similar improvement in lipid profile and serum glucose levels was found in both supplementations.","[{'ForeName': 'Z Jenko', 'Initials': 'ZJ', 'LastName': 'Pražnikar', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Polje 42, SI-6310 Izola, Slovenia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kenig', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Polje 42, SI-6310 Izola, Slovenia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vardjan', 'Affiliation': 'Kele & Kele, d.o.o., Laze 22/a, SI-1370 Logatec, Slovenia.'}, {'ForeName': 'M Černelič', 'Initials': 'MČ', 'LastName': 'Bizjak', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Polje 42, SI-6310 Izola, Slovenia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Petelin', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Polje 42, SI-6310 Izola, Slovenia. Electronic address: ana.petelin@upr.si.'}]",Journal of dairy science,['10.3168/jds.2019-17696']
191,32108304,Effects of ePREP and OurRelationship on Low-Income Couples' Mental Health and Health Behaviors: a Randomized Controlled Trial.,"Relationship distress is a pervasive problem in the USA that disproportionally impacts couples with low-income levels. The goal of the present study was to evaluate the effectiveness of two online relationship interventions, OurRelationship and ePREP, both of which were supported by a paraprofessional coach, in improving mental health and physical health behaviors with low-income couples. Couples (N = 742) were randomized to either intervention or a 6-month waitlist control group and assessed pre-, mid-, and post-intervention as well at 4 and 6 months after randomization. Results from multilevel models indicated that during treatment, compared to couples in the waitlist group, couples in the intervention groups reported significantly greater improvements in mental health that were small to moderate in magnitude (psychological distress, anger, problematic alcohol use, and perceived stress) as well as improvements in physical health/health behaviors (perceived health, insomnia, and exercise) that were small in magnitude. Furthermore, the differences between intervention and waitlist groups were maintained over follow-up. Treatment gains in both mental health and physical health behaviors were generally stronger for those who began treatment with greater difficulties in those areas. Implications of these findings with regard to intervention and policy are discussed.",2020,"Results from multilevel models indicated that during treatment, compared to couples in the waitlist group, couples in the intervention groups reported significantly greater improvements in mental health that were small to moderate in magnitude (psychological distress, anger, problematic alcohol use, and perceived stress) as well as improvements in physical health/health behaviors (perceived health, insomnia, and exercise) that were small in magnitude.",['Couples (N\u2009=\u2009742'],"['intervention or a 6-month waitlist control group and assessed pre-, mid-, and post-intervention', 'ePREP and OurRelationship']","['physical health/health behaviors (perceived health, insomnia, and exercise', 'magnitude (psychological distress, anger, problematic alcohol use, and perceived stress', 'mental health and physical health behaviors', ""Low-Income Couples' Mental Health and Health Behaviors"", 'mental health']","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018687'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",742.0,0.0499119,"Results from multilevel models indicated that during treatment, compared to couples in the waitlist group, couples in the intervention groups reported significantly greater improvements in mental health that were small to moderate in magnitude (psychological distress, anger, problematic alcohol use, and perceived stress) as well as improvements in physical health/health behaviors (perceived health, insomnia, and exercise) that were small in magnitude.","[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Department of Psychology, Univeristy of Miami, Coral Gables, FL, USA. mkr19@miami.edu.'}, {'ForeName': 'Galena K', 'Initials': 'GK', 'LastName': 'Rhoades', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Doss', 'Affiliation': 'Department of Psychology, Univeristy of Miami, Coral Gables, FL, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01100-y']
192,32298202,Long-Term Outcomes From a Randomized Dose Optimization Study of Chimeric Antigen Receptor Modified T Cells in Relapsed Chronic Lymphocytic Leukemia.,"PURPOSE


To describe long-term outcomes of anti-CD19 chimeric antigen receptor T (CART) cells in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
METHODS


Between January 2013 and June 2016, 42 patients with relapsed or refractory CLL were enrolled in this study and 38 were infused with anti-CD19 CART cells (CART-19). Of these, 28 patients were initially randomly assigned to receive a low (5 × 10 7 ) or high (5 × 10 8 ) dose of CART-19, and 24 were evaluable for response assessment. After an interim analysis, 10 additional patients received the selected (high) dose and of these, eight were evaluable for response. Patients were followed for a median 31.5 months (range, 2 to 75 months).
RESULTS


At 4 weeks, the complete and overall responses for the 32 evaluable patients were 28% (90% CI, 16% to 44%) and 44% (90% CI, 29% to 60%), respectively. The median overall survival (OS) for all patients was 64 months; there was no statistically significant difference between low- and high-dose groups ( P  = .84). Regardless of dose, prolonged survival was observed in patients who achieved a CR versus those who did not ( P  = .035), with median OS not reached in patients with CR versus 64 months in those without CR. The median progression-free survival was 40.2 months in patients with CR and 1 month in those without a CR ( P  < .0001). Toxicity was comparable in both dose groups.
CONCLUSION


In patients with advanced CLL, a 5 × 10 8  dose of CART-19 may be more effective than 5 × 10 7  CART-19 at inducing CR without excessive toxicity. Attainment of a CR after CART-19 infusion, regardless of cell dose, is associated with longer OS and progression-free survival in patients with relapsed CLL.",2020,"Regardless of dose, prolonged survival was observed in patients who achieved a CR versus those who did not ( P  = .035), with median OS not reached in patients with CR versus 64 months in those without CR.","['Relapsed Chronic Lymphocytic Leukemia', '28 patients', 'patients with relapsed CLL', 'Between January 2013 and June 2016, 42 patients with relapsed or refractory CLL', 'patients with relapsed or refractory chronic lymphocytic leukemia (CLL', 'patients with advanced CLL']","['Chimeric Antigen Receptor Modified T Cells', 'anti-CD19 CART cells (CART-19', 'anti-CD19 chimeric antigen receptor T (CART) cells']","['median progression-free survival', 'complete and overall responses', 'longer OS and progression-free survival', 'prolonged survival', 'Toxicity', 'median overall survival (OS', 'median OS']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278791', 'cui_str': 'Chronic lymphocytic leukaemia refractory'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C4039583', 'cui_str': 'Chimeric antigen receptor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",42.0,0.138082,"Regardless of dose, prolonged survival was observed in patients who achieved a CR versus those who did not ( P  = .035), with median OS not reached in patients with CR versus 64 months in those without CR.","[{'ForeName': 'Noelle V', 'Initials': 'NV', 'LastName': 'Frey', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Saar', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Elizabeth O', 'Initials': 'EO', 'LastName': 'Hexner', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Schuster', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Nasta', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Loren', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Svoboda', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Stadtmauer', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Landsburg', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mato', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Levine', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Simon F', 'Initials': 'SF', 'LastName': 'Lacey', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jan Joseph', 'Initials': 'JJ', 'LastName': 'Melenhorst', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Veloso', 'Affiliation': 'Center for Cellular Immunotherapies, Department of Pathology and Laboratory Medicine, Philadelphia, PA.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Gaymon', 'Affiliation': 'Center for Cellular Immunotherapies, Department of Pathology and Laboratory Medicine, Philadelphia, PA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Pequignot', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Xinhe', 'Initials': 'X', 'LastName': 'Shan', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Hwang', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'June', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Porter', 'Affiliation': 'Cell Therapy and Transplant Program, Division of Hematology-Oncology, Department of Medicine, Philadelphia, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03237']
193,31557380,"Metformin blunts muscle hypertrophy in response to progressive resistance exercise training in older adults: A randomized, double-blind, placebo-controlled, multicenter trial: The MASTERS trial.","Progressive resistance exercise training (PRT) is the most effective known intervention for combating aging skeletal muscle atrophy. However, the hypertrophic response to PRT is variable, and this may be due to muscle inflammation susceptibility. Metformin reduces inflammation, so we hypothesized that metformin would augment the muscle response to PRT in healthy women and men aged 65 and older. In a randomized, double-blind trial, participants received 1,700 mg/day metformin (N = 46) or placebo (N = 48) throughout the study, and all subjects performed 14 weeks of supervised PRT. Although responses to PRT varied, placebo gained more lean body mass (p = .003) and thigh muscle mass (p < .001) than metformin. CT scan showed that increases in thigh muscle area (p = .005) and density (p = .020) were greater in placebo versus metformin. There was a trend for blunted strength gains in metformin that did not reach statistical significance. Analyses of vastus lateralis muscle biopsies showed that metformin did not affect fiber hypertrophy, or increases in satellite cell or macrophage abundance with PRT. However, placebo had decreased type I fiber percentage while metformin did not (p = .007). Metformin led to an increase in AMPK signaling, and a trend for blunted increases in mTORC1 signaling in response to PRT. These results underscore the benefits of PRT in older adults, but metformin negatively impacts the hypertrophic response to resistance training in healthy older individuals. ClinicalTrials.gov Identifier: NCT02308228.",2019,CT scan showed that increases in thigh muscle area (p = .005) and density (p = .020) were greater in placebo versus metformin.,"['healthy older individuals', 'healthy women and men aged 65 and older', 'older adults']","['Metformin', 'metformin', 'progressive resistance exercise training', 'placebo', '1,700\xa0mg/day metformin', 'CT scan', 'Progressive resistance exercise training (PRT']","['thigh muscle area', 'AMPK signaling', 'hypertrophic response', 'lean body mass', 'blunted strength gains', 'thigh muscle mass', 'satellite cell or macrophage abundance with PRT']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}]",,0.25806,CT scan showed that increases in thigh muscle area (p = .005) and density (p = .020) were greater in placebo versus metformin.,"[{'ForeName': 'R Grace', 'Initials': 'RG', 'LastName': 'Walton', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Cory M', 'Initials': 'CM', 'LastName': 'Dungan', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Long', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kosmac', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Bailey D', 'Initials': 'BD', 'LastName': 'Peck', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Villasante Tezanos', 'Affiliation': 'Department of Statistics, College of Arts & Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Windham', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kern', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Peterson', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}]",Aging cell,['10.1111/acel.13039']
194,30740698,Pono Choices: Lessons for School Leaders From the Evaluation of a Teen Pregnancy Prevention Program.,"BACKGROUND


The US Office of Adolescent Health (OAH) funded studies of teen pregnancy and sexually transmitted infection (STI) prevention programs in 2010. The results of a 5-year OAH study conducted in the state of Hawai'i with middle school youth has implications for school leaders in the selection and implementation of comprehensive sex education curricula yielding positive outcomes for youth.
METHODS


A cluster randomized controlled trial was conducted across 34 middle school in the state of Hawai'i with 1783 student participants in pre-, post-, and 1-year follow-up surveys to determine effectiveness of a culturally responsive teen pregnancy prevention curriculum, called Pono Choices, specifically developed for youth in Hawai'i.
RESULTS


Students receiving the Pono Choices curriculum had significantly higher rates of knowledge gains than students in control schools, although there were no statistically significant differences in initiation of sexual activity between the groups at the 1-year follow-up. Teachers implemented the curriculum at high rates of adherence to fidelity making this a model for implementation.
CONCLUSIONS


Knowledge and retention of medically accurate teen pregnancy and STI prevention information can be attributed to implementation of a comprehensive program with attention to factors such as fidelity, program quality, engagement, and dosage.",2019,"RESULTS


Students receiving the Pono Choices curriculum had significantly higher rates of knowledge gains than students in control schools, although there were no statistically significant differences in initiation of sexual activity between the groups at the 1-year follow-up.","[""34 middle school in the state of Hawai'i with 1783 student participants in pre-, post-, and 1-year follow-up surveys to determine effectiveness of a culturally responsive teen pregnancy prevention curriculum, called Pono Choices, specifically developed for youth in Hawai'i""]",[],"['initiation of sexual activity', 'rates of knowledge gains']","[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018619', 'cui_str': 'Hawaii'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0032968', 'cui_str': 'Pregnancy, Adolescent'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],"[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0313001,"RESULTS


Students receiving the Pono Choices curriculum had significantly higher rates of knowledge gains than students in control schools, although there were no statistically significant differences in initiation of sexual activity between the groups at the 1-year follow-up.","[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Manaseri', 'Affiliation': 'Educational Leadership, State University of New York at Cortland, 22 Graham Avenue, Cortland, NY 13045.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Roberts', 'Affiliation': 'Institute for Human Development at Northern Arizona University, South San Francisco Street, Flagstaff, AZ 86011.'}, {'ForeName': 'Linda Toms', 'Initials': 'LT', 'LastName': 'Barker', 'Affiliation': 'IMPAQ International, LLC, 630 Kilauea Avenue, Hilo, HI 96720.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Tom', 'Affiliation': 'University of Hawaii at Manoa, 1410 Lower Campus Road #171F, Honolulu, HI 96826.'}]",The Journal of school health,['10.1111/josh.12733']
195,32293374,"Short-term efficacy of reducing screen media use on physical activity, sleep, and physiological stress in families with children aged 4-14: study protocol for the SCREENS randomized controlled trial.","BACKGROUND


During the recent decade presence of digital media, especially handheld devices, in everyday life, has been increasing. Survey data suggests that children and adults spend much of their leisure on screen media, including use of social media and video services. Despite much public debate on possible harmful effects of such behavioral shifts, evidence from rigorously conducted randomized controlled trials in free-living settings, investigating the efficacy of reducing screen media use on physical activity, sleep, and physiological stress, is still lacking. Therefore, a family and home-based randomized controlled trial - the SCREENS trial - is being conducted. Here we describe in detail the rationale and protocol of this study.
METHODS


The SCREENS pilot trial was conducted during the fall of 2018 and spring of 2019. Based on experiences from the pilot study, we developed a protocol for a parallel group randomized controlled trial. The trial is being conducted from May 2019 to ultimo 2020 in 95 families with children 4-14 years recruited from a population-based survey. As part of the intervention family members must handover most portable devices for a 2-week time frame, in exchange for classic mobile phones (not smartphones). Also, entertainment-based screen media use during leisure must be limited to no more than 3 hours/week/person. At baseline and follow-up, 7-day 24-h physical activity will be assessed using two triaxial accelerometers; one at the right hip and one the middle of the right thigh. Sleep duration will be assessed using a single channel EEG-based sleep monitor system. Also, to assess physiological stress (only assessed in adults), parameters of 24-h heart rate variability, the cortisol awakening response and diurnal cortisol slope will be quantified using data sampled over three consecutive days. During the study we will objectively monitor the families' screen media use via different software and hardware monitoring systems.
DISCUSSION


Using a rigorous study design with state-of-the-art methodology to assess outcomes and intervention compliance, analyses of data from the SCREENS trial will help answer important causal questions of leisure screen media habits and its short-term influence on physical activity, sleep, and other health related outcomes among children and adults.
TRIAL REGISTRATION


NCT04098913 at https://clinicaltrials.gov [20-09-2019, retrospectively registered].",2020,The trial is being conducted from May 2019 to ultimo 2020 in 95 families with children 4-14 years recruited from a population-based survey.,"['2019 to ultimo 2020 in 95 families with children 4-14\u2009years recruited from a population-based survey', 'families with children aged 4-14', 'fall of 2018 and spring of 2019', 'https://clinicaltrials.gov [20-09-2019, retrospectively registered', 'children and adults']",[],"['parameters of 24-h heart rate variability, the cortisol awakening response and diurnal cortisol slope', 'physiological stress', 'physical activity, sleep, and physiological stress', 'Sleep duration']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]",95.0,0.150773,The trial is being conducted from May 2019 to ultimo 2020 in 95 families with children 4-14 years recruited from a population-based survey.,"[{'ForeName': 'Martin Gillies Banke', 'Initials': 'MGB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark. mgrasmussen@health.sdu.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Pedersen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Line Grønholt', 'Initials': 'LG', 'LastName': 'Olesen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Klakk', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Peter Lund', 'Initials': 'PL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Jan Christian', 'Initials': 'JC', 'LastName': 'Brønd', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Grøntved', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, University of Southern Denmark, 5230, Odense, Denmark. agroentved@health.sdu.dk.'}]",BMC public health,['10.1186/s12889-020-8458-6']
196,32304185,The course of pain intensity and frequency of adolescents treated because of temporomandibular disorders: A long-term follow-up.,"OBJECTIVES


To evaluate the course of pain intensity and frequency related to temporomandibular disorders (TMDs) 15 years (range 5-21 years) after having received TMD treatment as adolescents due to frequent (at least once a week) TMD pain in two controlled trials.
MATERIALS AND METHODS


In the first trial, subjects (n = 122) were randomly allocated to either information only, received in a control condition (Co), or information and an occlusal appliance (OA) versus relaxation therapy (RT). In the second trial, including 64 subjects, nonresponders to OA or RT were subsequently allocated to the alternate treatment (ST). All study participants having completed the trials (n = 167) were invited to a long-term follow-up evaluations, with a response rate of 69.5% (n = 116). Patient-reported outcomes of TMD-related frequency and intensity were appraised relative to baseline data and short-term outcomes as observed in the two trials by use of general linear mixed model and generalized estimation equation statistics.
RESULTS


A significantly higher proportion of participants treated with OA and in the combined RT/Co condition than those in the ST group, reported a frequency level of TMD pain less than once week at post-treatment and the long-term follow-up. Adolescents treated with OA showed significantly lower TMD pain intensity levels post-treatment than those in the other two treatment conditions. While no difference between the OA and the RT/Co conditions was found in the long-term follow-up, participants in these two conditions were significantly more improved than those in the ST group.
CONCLUSION


Adolescents treated with an OA clearly showed better outcome with regard to intensity and frequency in a long-term follow-up of TMD pain than those treated with RT and ST for nonresponders. These latter individuals need special clinical attention and more effective supplementary treatment methods to be developed.",2020,Adolescents treated with OA showed significantly lower TMD pain intensity levels post-treatment than those in the other two treatment conditions.,"['64 subjects, nonresponders to OA or RT', 'subjects (n = 122', 'temporomandibular disorders (TMDs) 15\u2009years (range 5-21\u2009years) after having received TMD treatment as adolescents due to frequent (at least once a week) TMD pain in two controlled trials', 'All study participants having completed the trials (n = 167']","['control condition (Co), or information and an occlusal appliance (OA) versus relaxation therapy (RT', 'OA']","['pain intensity and frequency of adolescents treated because of temporomandibular disorders', 'frequency level of TMD pain', 'OA and the RT/Co conditions', 'TMD pain intensity levels']","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4517595', 'cui_str': '167'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",167.0,0.031744,Adolescents treated with OA showed significantly lower TMD pain intensity levels post-treatment than those in the other two treatment conditions.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Wahlund', 'Affiliation': 'Department of Stomatognathic Physiology, Kalmar County Hospital, Kalmar, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Larsson', 'Affiliation': 'Regional Center for Child and Youth Mental Health and Child Welfare - Central Norway, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Clinical and experimental dental research,['10.1002/cre2.289']
197,32094049,Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial.,"OBJECTIVE


The aim of this study was to assess the effectiveness of gentamicin containing collagen implants in the reduction of surgical site infections (SSIs) in patients undergoing an inguinal incision for vascular surgery.
METHODS


Prospective blinded randomised controlled multicentre trial (RCT), performed in four hospitals in The Netherlands and Belgium. This study included 288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015. Patients were randomised to receive a gentamicin implant (study group) or no implant (control group). The calculated sample sizes of 304 patients per group were not reached. Primary outcome was SSI incidence after six weeks. Secondary outcomes were time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality.
RESULTS


One hundred fifty-one patients were allocated to the study group (mean age 69 ± 9.2 years) and 137 patients were allocated to the control group (mean age 70 ± 10.4 years). Both groups were homogeneous regarding baseline and intra-operative characteristics. Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17). In a post hoc analysis comparing two study sites with low (<10%) and two study sites with high (>10%) infection rates in the control group, gentamicin implants significantly reduced SSIs in high risk centres (22% vs. 1%, p < .001), whereas there was no significant effect in low risk centres (13% vs. 7%, p = .30). There were no allergic reactions and all secondary outcomes were comparable between groups.
CONCLUSION


Gentamicin implants did not result in a significant overall reduction of SSIs in this RCT. Gentamicin implants did reduce the incidence of SSIs in high risk centres and may be a valuable adjunct to improve outcomes in such vascular centres with a high incidence of wound infections. However, the limitation of not reaching the calculated sample sizes should be considered.",2020,"Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17).","['Vascular Surgery', 'patients undergoing an inguinal incision for vascular surgery', 'four hospitals in The Netherlands and Belgium', 'One hundred fifty-one patients were allocated to the study group (mean age 69\xa0±\xa09.2 years) and 137 patients were allocated to the control group (mean age 70\xa0±\xa010.4 years', '288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015']","['gentamicin', 'Gentamicin implants', 'gentamicin containing collagen implants', 'gentamicin implant (study group) or no implant (control group', 'Gentamicin', 'Gentamicin Containing Collagen Implants']","['SSI incidence', 'infection rates', 'allergic reactions', 'surgical site infections (SSIs', 'low risk centres', 'time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality', 'SSIs']","[{'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457812', 'cui_str': 'Incision of inguinal region'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0189660', 'cui_str': 'Repair of artery (procedure)'}, {'cui': 'C0398048', 'cui_str': 'Endarterectomy of femoral artery'}, {'cui': 'C0190932', 'cui_str': 'Femoral-popliteal artery bypass graft (procedure)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0162575', 'cui_str': 'Embolectomy'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0590992', 'cui_str': 'Collagen implant (substance)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",288.0,0.25034,"Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17).","[{'ForeName': 'Lina F', 'Initials': 'LF', 'LastName': 'Wübbeke', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, the Netherlands.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Telgenkamp', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'Tiemen', 'Initials': 'T', 'LastName': 'van Boxtel', 'Affiliation': 'Department of Surgery, St. Elisabeth Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Lars J J', 'Initials': 'LJJ', 'LastName': 'Bolt', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Houthoofd', 'Affiliation': 'Department of Vascular Surgery, Leuven University Hospital, Leuven, Belgium.'}, {'ForeName': 'Patrick W H E', 'Initials': 'PWHE', 'LastName': 'Vriens', 'Affiliation': 'Department of Surgery, St. Elisabeth Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Bouwman', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'Barend M E', 'Initials': 'BME', 'LastName': 'Mees', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, the Netherlands. Electronic address: barend.mees@mumc.nl.'}, {'ForeName': 'Jan Willem H C', 'Initials': 'JWHC', 'LastName': 'Daemen', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, the Netherlands.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.01.010']
198,31835278,Architecting Process of Care: A randomized controlled study evaluating the impact of providing nonadherence information and pharmacist assistance to physicians.,"OBJECTIVE


To test the impact of connecting physicians, pharmacists, and patients to address medication nonadherence, and to compare different physician choice architectures.
DATA SOURCES AND STUDY SETTING


The study was conducted with 90 physicians and 2602 of their patients on medications treating chronic illness.
STUDY DESIGN


In this cluster randomized controlled trial, physicians were randomly assigned to an arm where the physician receives notification of patient nonadherence derived from real-time claims data, an arm where they receive this information and a pharmacist may contact patients either by default or by physician choice, and a control group. The primary outcome was resolving nonadherence within 30 days. We also considered physician engagement outcomes including viewing information about nonadherence and utilizing a pharmacist.
DATA COLLECTION


Physician engagement was constructed from metadata from the study website; adherence outcomes were constructed from medication claims.
PRINCIPAL FINDINGS


We see no differences between the treatment arms and control for the primary adherence outcome. The pharmacist intervention was 42 percentage points (95% CI: 28 pp-56 pp) more likely when it was triggered by default.
CONCLUSIONS


Access to a pharmacist and real-time nonadherence information did not improve patient adherence. Physician process of care was sensitive to choice architecture.",2020,"The pharmacist intervention was 42 percentage points (95% CI: 28 pp-56 pp) more likely when it was triggered by default.
","['Architecting Process of Care', '90 physicians and 2602 of their patients on medications treating chronic illness']","['physician receives notification of patient nonadherence derived from real-time claims data, an arm where they receive this information and a pharmacist may contact patients either by default or by physician choice, and a control group']","['resolving nonadherence within 30\xa0days', 'patient adherence']","[{'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0376405', 'cui_str': 'Patient Non-Compliance'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}]",,0.10001,"The pharmacist intervention was 42 percentage points (95% CI: 28 pp-56 pp) more likely when it was triggered by default.
","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rogers', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Simeonova', 'Affiliation': 'Johns Hopkins Carey School of Business, Baltimore, Maryland.'}, {'ForeName': 'Ira B', 'Initials': 'IB', 'LastName': 'Wilson', 'Affiliation': 'Brown University School of Public Health, Providence, Rhode Island.'}]",Health services research,['10.1111/1475-6773.13243']
199,31227432,Randomized Phase II Trial of Abiraterone Alone or With Dasatinib in Men With Metastatic Castration-resistant Prostate Cancer (mCRPC).,"BACKGROUND


Signaling via the Src pathway is thought to be a mediator of resistance to androgen targeted therapy in prostate cancer. We studied whether adding the Src inhibitor dasatinib to abiraterone would delay progression.
PATIENTS AND METHODS


Eligible patients had metastatic castration-resistant prostate cancer (mCRPC), without prior chemotherapy. Abiraterone was prescribed at 1000 mg daily with prednisone 5 mg twice daily in both arms, and dasatinib 100 mg daily was added for Arm B. The primary endpoint was progression-free survival (PFS). The interim analysis was planned after 48 subjects, but the study was terminated early. PFS was evaluated using a 1-sided log rank test. The Fisher exact test was used for other categorical data analyses. Circulating tumor cells (CTCs) were identified with the Epic platform.
RESULTS


With 26 men randomized and a median follow up of 41.8 months, the median PFS was 15.7 months (95% confidence interval, 8.2-49.0+ months) for Arm B and 9.0 months (95% confidence interval, 4.4-30.7 months) for Arm A (P = .15). Response Evaluation Criteria in Solid Tumors responses were seen in 5 (36%) of 14 patients, including 2 complete responses (CRs) on Arm B, and 2 (17%) of 12 responses without CR on Arm A (P = .39). Grade ≥ 3 toxicities more common in Arm B included hypertension, pleural effusion/dyspnea, and gastrointestinal effects. CTCs were detected at baseline in 10 of 19 evaluable patients (median, 2.7/mL blood [range 0.41-59.7]). At week 4, CTCs increased in 1 (10%) of 10 patients on Arm A and 4 (44%) of 9 patients on Arm B.
CONCLUSION


Dasatinib did not significantly prolong PFS in combination with abiraterone, although power was limited owing to the incomplete study cohort. Treatment with the combination was associated with robust objective responses, including Response Evaluation Criteria in Solid Tumors CRs.",2019,"Dasatinib did not significantly prolong PFS in combination with abiraterone, although power was limited owing to the incomplete study cohort.","['Eligible patients had metastatic castration-resistant prostate cancer (mCRPC), without prior chemotherapy', 'Men With Metastatic Castration-resistant Prostate Cancer']","['prednisone', 'Abiraterone', 'abiraterone', 'Alone or With Dasatinib']","['progression-free survival (PFS', 'Circulating tumor cells (CTCs', 'hypertension, pleural effusion/dyspnea, and gastrointestinal effects', 'PFS', 'CTCs', 'median PFS', 'Grade\xa0≥ 3 toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027625', 'cui_str': 'Circulating Tumor Cells'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.248961,"Dasatinib did not significantly prolong PFS in combination with abiraterone, although power was limited owing to the incomplete study cohort.","[{'ForeName': 'Tanya B', 'Initials': 'TB', 'LastName': 'Dorff', 'Affiliation': 'Department of Medical Oncology and Developmental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA. Electronic address: tdorff@coh.org.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Division of Medical Oncology, USC Keck School of Medicine, Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Jacek K', 'Initials': 'JK', 'LastName': 'Pinski', 'Affiliation': 'Division of Medical Oncology, USC Keck School of Medicine, Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Goldkorn', 'Affiliation': 'Division of Medical Oncology, USC Keck School of Medicine, Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Sarmad', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Division of Medical Oncology, USC Keck School of Medicine, Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Denice', 'Initials': 'D', 'LastName': 'Tsao-Wei', 'Affiliation': 'Department of Prevention and Biostatistics, USC Keck School of Medicine, Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Groshen', 'Affiliation': 'Department of Prevention and Biostatistics, USC Keck School of Medicine, Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kuhn', 'Affiliation': 'Michelson Center for Convergent Biosciences, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Gross', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine of USC and Norris Comprehensive Cancer Center, USC Keck School of Medicine, Los Angeles, CA.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.02.010']
200,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


The objective of this study is to evaluate the progression and new onset of macular retinoschisis (MRS) in the patients treated with intravitreal Conbercept injections for myopic choroidal neovascularization (mCNV).
METHODS


Post-hoc analysis of 160 mCNV patients included in SHINY study was performed to evaluate the impact of Conbercept injection on MRS in patients with mCNV undergoing intravitreal Conbercept injections. The patients were 3:1 randomized to the study group (three loading dose and thereafter pro re nata [PRN]) and the control group (3 months' sham injection, then one Conbercept injection at month 4 and thereafter PRN). MRS was assessed with optical coherence tomography by masked graders.
RESULTS


At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
201,30419989,"Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials.","OBJECTIVE


Two similarly designed extension studies evaluated the long-term safety and tolerability of desvenlafaxine for the treatment of children and adolescents with major depressive disorder (MDD). Efficacy was evaluated as a secondary objective.
METHODS


Both 6-month, open-label, flexible-dose extension studies enrolled children and adolescents who had completed one of two double-blind, placebo-controlled, lead-in studies. One lead-in study included a 1-week transition period prior to the extension study. Patients received 26-week treatment with flexible-dose desvenlafaxine (20-50 mg/d). Safety assessments included comprehensive psychiatric evaluations, vital sign assessments, laboratory evaluations, 12-lead electrocardiogram, physical examination with Tanner assessment, and Columbia-Suicide Severity Rating Scale. Adverse events (AEs) were collected throughout the studies. Efficacy was assessed using the Children's Depression Rating Scale-Revised (CDRS-R).
RESULTS


A total of 552 patients enrolled (completion rates: 66.4 and 69.1%). AEs were reported by 79.4 and 79.1% of patients in the two studies; 8.9 and 5.2% discontinued due to AEs. Treatment-emergent suicidal ideation or behavior was reported for 16.6 and 14.1% of patients in the two studies. Mean (SD) CDRS-R total score decreased from 33.83 (11.93) and 30.92 (10.20) at the extension study baseline to 24.31 (7.48) and 24.92 (8.45), respectively, at week 26.
CONCLUSION


Desvenlafaxine 20 to 50 mg/d was generally safe and well tolerated with no new safety signals identified in children and adolescents with MDD who received up to 6 months of treatment in these studies. Patients maintained the reduction in severity of depressive symptoms observed in all treatment groups at the end of the lead-in study.",2019,Patients maintained the reduction in severity of depressive symptoms observed in all treatment groups at the end of the lead-in study.,"['552 patients enrolled (completion rates: 66.4 and 69.1', 'studies enrolled children and adolescents who had completed one of two double-blind, placebo-controlled, lead-in studies', 'Children and Adolescents with Major Depressive Disorder', 'children and adolescents with major depressive disorder (MDD', 'children and adolescents with MDD']","['flexible-dose desvenlafaxine', 'desvenlafaxine', 'open-label, flexible-dose extension', 'Desvenlafaxine']","['Efficacy', 'safe and well tolerated', ""Children's Depression Rating Scale-Revised (CDRS-R"", 'Mean (SD) CDRS-R total score', 'suicidal ideation or behavior', 'severity of depressive symptoms', 'Safety, Tolerability, and Efficacy', 'comprehensive psychiatric evaluations, vital sign assessments, laboratory evaluations, 12-lead electrocardiogram, physical examination with Tanner assessment, and Columbia-Suicide Severity Rating Scale', 'Adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0518766'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0335730', 'cui_str': 'Tanner (occupation)'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",552.0,0.0805404,Patients maintained the reduction in severity of depressive symptoms observed in all treatment groups at the end of the lead-in study.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Atkinson', 'Affiliation': 'Finger Lakes Clinical Research, Rochester, New York.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Thurman', 'Affiliation': 'IPS Research, Oklahoma City, Oklahoma.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ramaker', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Buckley', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania.'}, {'ForeName': 'Sarah Ruta', 'Initials': 'SR', 'LastName': 'Jones', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'England', 'Affiliation': 'Pfizer Inc., Groton, Connecticut.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Wajsbrot', 'Affiliation': 'Pfizer Inc., New York, New York.'}]",CNS spectrums,['10.1017/S1092852918001128']
202,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS


This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE


Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS


The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
203,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS


Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
204,30306884,"Successful switching of patients with acute schizophrenia from another antipsychotic to brexpiprazole: comparison of clinicians' choice of cross-titration schedules in a post hoc analysis of a randomized, double-blind, maintenance treatment study.","OBJECTIVE


To compare the tolerability and efficacy of different antipsychotic cross-titration schedules, using data from a brexpiprazole study (Equator; NCT01668797).
METHODS


Patients with schizophrenia were cross-titrated from other antipsychotics to brexpiprazole monotherapy in a 1-4 week open-label conversion phase, then entered a single-blind brexpiprazole treatment phase. Patients were stratified into four ""conversion groups,"" according to the amount of time spent in the conversion phase. Discontinuation rates, treatment-emergent adverse events (TEAEs), and efficacy (Positive and Negative Syndrome Scale [PANSS]) were compared between conversion groups.
RESULTS


Of the 404 patients treated with brexpiprazole, the majority (72.0%) spent 22-33 days in the conversion phase. Discontinuation rates due to lack of efficacy or adverse events were low in all conversion groups. Of the 292 patients who successfully switched and completed 8 weeks of brexpiprazole treatment, most were converted to brexpiprazole over 22-33 days (80.1%), and fewer were converted over 1-7 days (2.4%), 8-14 days (6.5%), or 15-21 days (11.0%). The incidence of TEAEs over 8 weeks was lower among those converted over 22-33 days (44.4%) than in other conversion groups (62.5-84.2%), although low patient numbers with shorter conversion times limit the generalizability of this finding. Each conversion group showed comparable improvement in PANSS total score from baseline.
CONCLUSION


The majority of patients were cross-titrated to brexpiprazole over a period of 22-33 days, by investigators' choice. Additional data on shorter conversions may help clinicians to choose a switching paradigm that best meets their patients' needs.",2019,"The incidence of TEAEs over 8 weeks was lower among those converted over 22-33 days (44.4%) than in other conversion groups (62.5-84.2%), although low patient numbers with shorter conversion times limit the generalizability of this finding.","['292 patients who successfully switched and completed 8 weeks of', 'Patients with schizophrenia', '404 patients treated with brexpiprazole', 'patients with acute schizophrenia']","['brexpiprazole', 'antipsychotics to brexpiprazole monotherapy']","['efficacy or adverse events', 'tolerability and efficacy', 'Discontinuation rates, treatment-emergent adverse events (TEAEs), and efficacy (Positive and Negative Syndrome Scale [PANSS', 'incidence of TEAEs', 'PANSS total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",404.0,0.0463195,"The incidence of TEAEs over 8 weeks was lower among those converted over 22-33 days (44.4%) than in other conversion groups (62.5-84.2%), although low patient numbers with shorter conversion times limit the generalizability of this finding.","[{'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine, Hempstead, New York; and Recognition and Prevention (RAP) Program, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York; Charité Universitätsmedizin, Department of Child and Adolescent Psychiatry, Berlin, Germany.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hobart', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eramo', 'Affiliation': 'Lundbeck LLC, Deerfield, Illinois.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Duffy', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Weiller', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark(at the time of this work).'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Baker', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey.'}]",CNS spectrums,['10.1017/S1092852918001086']
205,32297837,Reducing Cardiovascular Disease Risk in Women Beyond Statin Therapy: New Insights 2020.,"Management of residual and persistent cardiovascular disease (CVD) risk among statin-treated individuals has emerged as an important preventive strategy. The purpose of this article is to review the unique landscape of CVD in women and relevant prior prevention trials, and to discuss how the recent results of the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) might apply to the contemporary management of CVD risk among statin-treated women. Women have unique risk factors that may impact CVD and its prevention. Historically, women have been underrepresented in CVD trials, posing a challenge to development of clinical recommendations for women. Low-density lipoprotein cholesterol-targeting treatments have demonstrated CVD risk reduction, with comparable effects in both sexes. In contrast, triglyceride-lowering treatments (niacin, fenofibrate, and omega-3 fatty acids) have reported mixed findings for CVD risk reduction. Recent clinical trials of combination omega-3 fatty acids (docosahexaenoic acid/eicosapentaenoic acid [EPA]) have not found significant CVD risk reduction. The recently published REDUCE-IT study found that icosapent ethyl, an EPA-only omega-3 fatty acid, in combination with statins, significantly reduced CVD events in high-risk patients. The icosapent ethyl group had a significantly lower occurrence of the primary composite CVD endpoint (17.2%) than the placebo group (22.0%; hazard ratio 0.75; 95% confidence interval 0.68-0.83;  p  < 0.001). CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33). Data from REDUCE-IT suggest women benefit similarly to men with respect to icosapent ethyl, a novel therapy for prevention of CVD.",2020,"CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33).",['high-risk patients'],"['triglyceride-lowering treatments (niacin, fenofibrate, and omega-3 fatty acids', 'placebo', 'combination omega-3 fatty acids (docosahexaenoic acid/eicosapentaenoic acid [EPA']","['CVD risk reduction', 'CVD events', 'primary composite CVD endpoint']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.0558982,"CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33).","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Mosca', 'Affiliation': 'Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Nanette Kass', 'Initials': 'NK', 'LastName': 'Wenger', 'Affiliation': ""Department of Cardiology, Emory University School of Medicine; Emory Heart and Vascular Center; Emory Women's Heart Center, Atlanta, Georgia, USA.""}]",Journal of women's health (2002),['10.1089/jwh.2019.8189']
206,31756059,Similar overall survival with reduced vs. standard dose bevacizumab monotherapy in progressive glioblastoma.,"INTRODUCTION


Bevacizumab has demonstrated activity in glioblastoma (GBM), but the true benefits and optimal dose-schedule are debated. A lower dose-schedule than standard-dose bevacizumab (10 mg/kg 2-weekly) might offer similar benefits with lower costs. At our Institution, patients are randomly assigned at time of primary diagnosis to Neuro-Oncologists, who have varying practices in terms of bevacizumab dose-schedule upon progression.
METHODS


In a retrospective analysis we examined overall survival (OS), measured from first administered bevacizumab dose until death, according to dose-schedule. Patients with de novo WHO Grade IV GBM who received standard- or reduced-dose (5 mg/kg 2-weekly) bevacizumab were included. MGMT methylation status and time from diagnosis to bevacizumab start were examined as prognostic variables. Clinical benefit and a comparative cost analysis were assessed.
RESULTS


In total, 1127 bevacizumab doses were administered to 118 patients [Median: 7, Range: 1-44]. Median OS (mOS) was 5.8 months. 69 (59%) patients received standard-dose bevacizumab (mOS: 5.97 months) and 49 patients received reduced-dose (mOS: 5.7 months). No statistically significant difference in OS between dosing schedule was seen (HR: 1.11, P-value: .584). Patients with MGMT methylated tumors (43%) had improved OS compared to those with unmethylated tumors; 7.03 vs 4.97 months (HR: 0.61, P-value: .027). If all patients were treated with reduced-dose bevacizumab, an estimated €2.4M cost reduction would be observed.
CONCLUSIONS


In this retrospective study, reduced-dose bevacizumab schedule resulted in similar OS to standard-dose bevacizumab monotherapy with substantial cost savings. MGMT methylation appears to convey a survival benefit in the setting of bevacizumab treatment for progressive GBM.",2020,"No statistically significant difference in OS between dosing schedule was seen (HR: 1.11, P-value: .584).",['Patients with de novo'],"['bevacizumab monotherapy', 'bevacizumab', 'Bevacizumab', 'standard-dose bevacizumab']","['OS', 'overall survival', 'overall survival (OS', 'survival benefit', 'Median OS (mOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1127.0,0.117465,"No statistically significant difference in OS between dosing schedule was seen (HR: 1.11, P-value: .584).","[{'ForeName': 'Jack Patrick', 'Initials': 'JP', 'LastName': 'Gleeson', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Keane', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Niamh M', 'Initials': 'NM', 'LastName': 'Keegan', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Emin', 'Initials': 'E', 'LastName': 'Mammadov', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Harrold', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alhusaini', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Harte', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Eakin-Love', 'Affiliation': 'Royal College of Surgeons of Ireland (RCSI), Dublin, Ireland.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': ""O'Halloran"", 'Affiliation': 'Neurosurgical Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'MacNally', 'Affiliation': 'Neurosurgical Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Bryan T', 'Initials': 'BT', 'LastName': 'Hennessy', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Oscar S', 'Initials': 'OS', 'LastName': 'Breathnach', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Grogan', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Morris', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}]",Cancer medicine,['10.1002/cam4.2616']
207,31213316,Evaluation of an individualized vs non-specific standardized patient activity in improving communication skills amongst pharmacy students.,"BACKGROUND AND PURPOSE


To evaluate the impact of two standardized patient (SP) approaches on student communication skills and self-perceived confidence.
EDUCATIONAL ACTIVITY AND SETTING


Second professional year pharmacy students were assessed on overall and area of improvement (AOI) communication skills and self-perceived confidence. Students were invited to participate in a SP intervention activity, following a fall and before a spring class assessment, where they were randomized to an individualized or non-specific SP group. Communication skills were assessed using a four component 64-point rubric; confidence was assessed using an 11-question Likert-type survey.
FINDINGS


Nineteen students participated in the SP intervention activity; 11 students comprised the individualized group and eight students comprised the non-specific group. Students in the individualized group demonstrated a significantly higher median change in AOI communication scores compared to the non-specific group [five points vs. three points, respectively (p = 0.033)]. There was a significantly higher median change in overall communication skills in the individualized compared to the non-specific group of 12 points and 6.5 points, respectively (p = 0.017). Student self-perceived confidence in the individualized and non-specific group showed similar improvements overall from pre- to post assessment [seven points vs. eight points, respectively (p = 0.62)].
SUMMARY


The use of SPs in pharmacy curricula can improve student communication skills. However, tailoring the activity to students' needs significantly improves their communication AOI and overall communication skill scores more than a non-specific activity. Student self-perceived confidence improved similarly in both groups, although no statistically significant differences were found between groups.",2019,"Students in the individualized group demonstrated a significantly higher median change in AOI communication scores compared to the non-specific group [five points vs. three points, respectively (p = 0.033)].","['Nineteen students participated in the SP intervention activity; 11 students comprised the individualized group and eight students comprised the non-specific group', 'pharmacy students', 'Students were invited to participate in a SP intervention activity, following a fall and before a spring class assessment']","['individualized vs non-specific standardized patient activity', 'individualized or non-specific SP group']","['communication AOI and overall communication skill scores', 'overall and area of improvement (AOI) communication skills and self-perceived confidence', 'median change in AOI communication scores', 'Communication skills', 'overall communication skills', 'Student self-perceived confidence']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",19.0,0.0245221,"Students in the individualized group demonstrated a significantly higher median change in AOI communication scores compared to the non-specific group [five points vs. three points, respectively (p = 0.033)].","[{'ForeName': 'Brooklyn T', 'Initials': 'BT', 'LastName': 'Cobb', 'Affiliation': 'Philadelphia College of Pharmacy, University of the Sciences, 600 S. 43rd Street, Philadelphia, PA 19104, United States. Electronic address: b.cobb@usciences.edu.'}, {'ForeName': 'Jane F', 'Initials': 'JF', 'LastName': 'Bowen', 'Affiliation': 'Philadelphia College of Pharmacy, 600 S. 43rd Street, Philadelphia, PA 19104, United States. Electronic address: j.bowen@usciences.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pontiggia', 'Affiliation': 'Misher College, University of the Sciences, 600 South 43rd St., Philadelphia, PA 19104, United States. Electronic address: l.pontig@usciences.edu.'}, {'ForeName': 'Katherine F', 'Initials': 'KF', 'LastName': 'Koffer', 'Affiliation': 'Philadelphia College of Pharmacy, 600 S. 43rd Street, Philadelphia, PA 19104, United States. Electronic address: k.koffer@usciences.edu.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Scholtz', 'Affiliation': 'Department of Pharmacy Practice and Pharmacy Administration, Philadelphia College of Pharmacy, 600 S. 43rd St., Philadelphia, PA 19104, United States. Electronic address: j.scholt@usciences.edu.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2019.02.022']
208,31026086,"Analgesic efficacy and pharmacokinetics of epidural oxycodone in pain management after gynaecological laparoscopy-A randomised, double blind, active control, double-dummy clinical comparison with intravenous administration.","AIMS


Early pain after laparoscopy is often severe. Oxycodone is a feasible analgesic option after laparoscopy, but there are sparse data on epidural administration. The aim was to evaluate the analgesic efficacy and pharmacokinetics of a single dose of epidural oxycodone as a part of multimodal analgesia after gynaecological laparoscopy.
METHODS


Women (n = 60), aged 23-71 years, undergoing elective gynaecological laparoscopy, were administrated either epidural oxycodone 0.1 mg kg -1  and intravenous (i.v.) saline (EPI-group n = 31), or epidural saline and i.v. oxycodone 0.1 mg kg -1  (IV-group = 29) in a randomised, double blind, active control, double dummy clinical trial. A pharmacokinetic model was developed using population modelling of plasma and cerebrospinal fluid (CSF) concentrations obtained in these patients and data of 2 published studies. The primary outcome was the amount of i.v. fentanyl for rescue analgesia during the first 4 hours.
RESULTS


Twenty of the 31 patients in the EPI-group and 26 of the 29 patients in the IV-group needed i.v. fentanyl for rescue analgesia, P = .021. The median (interquartile range) number of fentanyl doses were 1.0 (1.0-3.0) in the EPI-group and 2.5 (1.0-4.0) doses in the IV-group, P = .008. Plasma concentrations were similar, but CSF concentrations were 100-fold higher in the EPI-group. The population model indicated that 60% of oxycodone injected into the epidural space enters into CSF and 40% is absorbed into the systemic circulation.
CONCLUSIONS


The data support superiority of epidural administration of oxycodone compared to i.v. administration during the first hours after laparoscopic surgery. This is likely to be based on enhanced permeation into the central nervous system after epidural administration.",2019,"Plasma concentrations were similar, but CSF concentrations were 100-fold higher in the EPI-group.","['Twenty of the 31 patients in the EPI-group and 26 of the 29 patients in the IV-group needed i.v', 'pain management after gynaecological laparoscopy', 'Women (n\xa0=\xa060), aged 23-71\xa0years, undergoing']","['oxycodone', 'epidural saline', 'fentanyl', 'elective gynaecological laparoscopy', 'Oxycodone', 'saline', 'epidural oxycodone']","['median (interquartile range) number of fentanyl doses', 'Analgesic efficacy and pharmacokinetics', 'CSF concentrations', 'amount of i.v', 'Plasma concentrations', 'analgesic efficacy and pharmacokinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.551475,"Plasma concentrations were similar, but CSF concentrations were 100-fold higher in the EPI-group.","[{'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Piirainen', 'Affiliation': 'School of Medicine, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kokki', 'Affiliation': 'School of Medicine, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': 'Departments of Anaesthesiology, and Pharmacology & Clinical Pharmacology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hannam', 'Affiliation': 'Departments of Anaesthesiology, and Pharmacology & Clinical Pharmacology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hautajärvi', 'Affiliation': 'Admescope Ltd, Oulu, Finland.'}, {'ForeName': 'Veli-Pekka', 'Initials': 'VP', 'LastName': 'Ranta', 'Affiliation': 'School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Kokki', 'Affiliation': 'Department of Anaesthesia and Operative Services, Kuopio University Hospital, Kuopio, Finland.'}]",British journal of clinical pharmacology,['10.1111/bcp.13971']
209,31462757,Sprint interval training versus moderate-intensity continuous training during inpatient rehabilitation after spinal cord injury: a randomized trial.,"STUDY DESIGN


Randomized trial.
OBJECTIVES


To evaluate the effectiveness of a 5-week sprint interval training (SIT) protocol on an arm-crank ergometer in individuals with sub-acute spinal cord injury (SCI).
SETTING


Inpatient rehabilitation.
METHODS


Individuals with SCI (N = 20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46 ± 16 years; 15 M/5 F) were randomized to SIT or moderate-intensity continuous training (MICT). SIT consisted of 3 × 20 s. 'all-out' cycle sprints (≥100% peak power output) interspersed with 2 min of active recovery (10% peak power output; total time commitment, 10 mins). MICT involved 20 min of cycling (45% peak power output; total time commitment, 25 mins). Both training interventions were delivered 3 times/week for 5 weeks. Heart rate and Borg's Rating of Perceived Exertion (RPE; 6-20) were monitored throughout training sessions. Maximal and sub-maximal power outputs were assessed on an arm-crank ergometer. Exercise enjoyment, exercise self-efficacy, and pain were assessed at the end of the intervention.
RESULTS


During training sessions, heart rate (135 bpm vs. 119 bpm; p = 0.05), peripheral RPE (16 vs. 12; p = 0.000), and central RPE (15 vs. 11; p = 0.004) responses were higher in the SIT group, yet total work performed was greater in MICT. Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524). Similarly, improvements in sub-maximal power output were not different across groups. There were no between-group differences in exercise enjoyment (p = 0.385), exercise self-efficacy (p = 0.930), or pain (p = 0780).
CONCLUSIONS


Five weeks of SIT improved physical capacity to the same extent as MICT in individuals with sub-acute SCI, despite a significantly lower time commitment with SIT.",2020,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","['inpatient rehabilitation after spinal cord injury', 'Individuals with SCI (N\u2009', 'Inpatient rehabilitation', '20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46\u2009±\u200916 years; 15\u2009M/5\u2009F', 'individuals with sub-acute spinal cord injury (SCI']","['MICT', 'SIT or moderate-intensity continuous training (MICT', 'Sprint interval training versus moderate-intensity continuous training', '5-week sprint interval training (SIT) protocol']","['sub-maximal power output', 'Exercise enjoyment, exercise self-efficacy, and pain', ""Heart rate and Borg's Rating of Perceived Exertion"", 'Peak power output', 'heart rate', 'physical capacity', 'exercise enjoyment', 'peripheral RPE', 'exercise self-efficacy', 'central RPE']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0449246', 'cui_str': 'Time since injury (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",780.0,0.0764155,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Mcleod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Herrington', 'Initials': 'H', 'LastName': 'Diana', 'Affiliation': 'Regional Rehabilitation Centre, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada. hicksal@mcmaster.ca.'}]",Spinal cord,['10.1038/s41393-019-0345-6']
210,31312016,Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


To determine the effects of advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES) of the quadriceps and gastrocnemius muscles on the ability of wheelchair-dependent people with spinal cord injury (SCI) to transfer and attain independence in activities of daily living (ADLs).
SETTING


An outpatient clinic, Iran.
METHODS


People with traumatic chronic paraplegia (N = 16) were randomly allocated to three groups. The exercise group (EX; N = 5) performed AWMEs of quadruped unilateral reaching and tall-kneeling for 24 weeks (3 days/week). Sessions were increased from 10 min to 54 min over the 24-week period. The exercise-FES group (EX + FES; N = 5) performed AWMEs simultaneously with FES of the quadriceps and gastrocnemius muscles. The control group performed no exercise and no FES (N = 6). The primary outcomes were the total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer. There were six other outcomes.
RESULTS


The mean (95% CI) between-group differences of the four transfer items of the SCIM-III for the EX vs. control group was 1.8 points (0.2-3.4), and for the EX + FES vs. control group was 2 points (0.4-3.6). The equivalent differences for the total SCIM-III scores were 2.7 points (-0.6-6.0) and 4.1 points (0.8-7.4), respectively. There were no significant between-group differences for any other outcomes.
CONCLUSIONS


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.",2020,"CONCLUSIONS


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","['People with traumatic chronic paraplegia (N\u2009=\u200916', 'wheelchair-dependent people with spinal cord injury (SCI', 'An outpatient clinic, Iran']","['no exercise and no FES', 'advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES', 'Advanced weight-bearing mat exercises combined with functional electrical stimulation', 'exercise group (EX; N\u2009=\u20095) performed AWMEs of quadruped unilateral reaching and tall-kneeling']","['total SCIM-III scores', 'total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C3698571', 'cui_str': 'Chronic paraplegia'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456677', 'cui_str': 'Total spinal blockade (finding)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0665244,"CONCLUSIONS


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Torkaman', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. torkamg@modares.ac.ir.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Ghabaee', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Departments of Medicine and Endocrinology, Austin Health, The University of Melbourne, Melbourne, VIC, Australia.'}]",Spinal cord,['10.1038/s41393-019-0328-7']
211,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN


Parallel-group, quasi-experimental study.
OBJECTIVES


To evaluate the effectiveness of a coping-oriented supportive programme (COSP) for people with spinal cord injury (SCI) over a 12-week follow-up.
SETTING


SCI wards in two rehabilitation hospitals of Shaanxi, China.
METHODS


Ninety-nine participants (mean age = 41, 88% males and 74% paraplegia) joined the COSP intervention (n = 50) or attention control (n = 49) group. The COSP intervention was focussed on the facilitation of coping skills and consisted of 8 weekly sessions, whereas the attentional control group was provided with 8 weekly didactic education sessions. Effects of the COSP intervention were determined by primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain). Data were collected at pre- and post-intervention, as well as 4- and 12-week follow-up.
RESULTS


Intention to treat analysis indicated statistically significant effects (with moderate to large effect sizes, all P-values < 0.01) on participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction immediately post-COSP. Statistically significant effects were found for maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction at 4-week follow-up. Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
CONCLUSION


The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2']
212,31442303,"Randomized trial of weight loss in primary breast cancer: Impact on body composition, circulating biomarkers and tumor characteristics.","Obesity adversely impacts overall and cancer-specific survival among breast cancer patients. Preclinical studies demonstrate negative energy balance inhibits cancer progression; however, feasibility and effects in patients are unknown. A two-arm, single-blinded, randomized controlled weight-loss trial was undertaken presurgery among 32 overweight/obese, Stage 0-II breast cancer patients. The attention control arm (AC) received basic nutritional counseling and upper-body progressive resistance training whereas the weight loss intervention (WLI) arm received identical guidance, plus counseling on caloric restriction and aerobic exercise to promote 0.68-0.92 kg/week weight loss. Anthropometrics, body composition, blood and survey data were collected at baseline and presurgery ∼30 days later. Tumor markers (e.g., Ki67) and gene expression were assessed on biopsy and surgical specimens; sera were analyzed for cytokines, growth and metabolic factors. Significant WLI vs. AC differences were seen in baseline-to-follow-up changes in weight (-3.62 vs. -0.52 kg), %body fat (-1.3 vs. 0%), moderate-to-vigorous physical activity (+224 vs. +115 min/week), caloric density (-0.3 vs. 0 kcal/g), serum leptin (-12.3 vs. -4.0 ng/dl) and upregulation of tumor PI3Kinase signaling and cell cycle-apoptosis related genes (CC-ARG; all p-values <0.05). Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity. Increased tumor (nuclear) TNFα and IL-1β, CX3CL1 and CXCL1 gene expression was observed in the WLI. Tumor Ki67 did not differ between arms. Feasibility benchmarks included 80% accrual, 100% retention, no adverse effects and excellent adherence. Short-term weight loss interventions are feasible; however, mixed effects on tumor biology suggest unclear benefit to presurgical caloric restriction, but possible benefits of physical activity.",2020,Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity.,"['breast cancer patients', '32 overweight/obese, stage 0-II', 'Primary Breast Cancer']","['basic nutritional counseling and upper-body progressive resistance training whereas the weight loss intervention (WLI) arm received identical guidance, plus counseling on caloric restriction and aerobic exercise']","['Obesity adversely impacts overall and cancer-specific survival', 'weight loss; CC-ARG', 'adverse effects, and excellent adherence', 'moderate-to-vigorous physical activity', 'CX3CL1, and CXCL1 gene expression', 'Tumor Ki67', 'caloric density', 'weight ', 'Increased tumor(nuclear) TNFα and IL-1β', 'Tumor markers (e.g., Ki67) and gene expression', 'Cytolytic CD56 dim  NK cell expression', 'serum leptin', 'body fat', 'Anthropometrics, body composition, blood, and survey data']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005768'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0244253,Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity.,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Gibson', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Frugé', 'Affiliation': 'Auburn University, Auburn, AL.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Oster', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Grizzle', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Lyse A', 'Initials': 'LA', 'LastName': 'Norian', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Eddy S', 'Initials': 'ES', 'LastName': 'Yang', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Della Manna', 'Affiliation': 'Department of Radiation Oncology, UAB, Birmingham, AL.'}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Azrad', 'Affiliation': 'Department of Human Nutrition, Tuscaloosa, AL.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Krontiras', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}]",International journal of cancer,['10.1002/ijc.32637']
213,31452049,Cognitive effects of dance-movement intervention in a mixed group of seniors are not dependent on hippocampal atrophy.,"Dance-movement intervention (DMI) offers multi-component stimulation of cognitive functions, and it may ameliorate cognitive deficits in the elderly. We investigated the effects of intensive DMI on the cognitive performances of healthy seniors (HS) and patients with mild cognitive impairment (MCI). In addition, we evaluated whether the baseline MRI hippocampus-to-cortex volume (HV:CTV) ratio (i.e., a marker of a typical AD-specific brain atrophy and of distribution of neurofibrillary tangles in the brain) has any impact on the DMI-induced cognitive changes. The research cohort consisted of 99 subjects who were randomly assigned (in a 1:1 ratio) to a DMI group or to a control (life-as-usual) group. The DMI group consisted of 49 subjects with an average age of 69.16 years (SD = 5.36), of which 34 were HS (69.4%) and 15 had MCI (30.6%). The control group consisted of 50 subjects aged 68.37 years (SD = 6.10), of which 31 were HC (62%) and 19 (38%) had MCI. The DMI group underwent a 6-month intervention, which consisted of 60 lessons supervised by a qualified instructor. Statistical analysis yielded a significant improvement of the figural fluency task as measured by the five-point test in the DMI group as compared to the control group [t (97) = 2.72; p = 0.008]. The baseline HV:CTV ratio was not associated with cognitive changes on that task or with changes in any cognitive domain's Z scores. We observed DMI-induced effect on the test evaluating executive functions across the spectrum of HS and MCI, which was not dependent on the magnitude of AD-related brain pathology.",2019,The baseline HV:CTV ratio was not associated with cognitive changes on that task or with changes in any cognitive domain's Z scores.,"['49 subjects with an average age of 69.16\xa0years (SD\u2009=\u20095.36), of which 34 were HS (69.4%) and 15 had MCI (30.6', '99 subjects', 'healthy seniors (HS) and patients with mild cognitive impairment (MCI']","['dance-movement intervention', 'intensive DMI', 'DMI group or to a control (life-as-usual) group', 'Dance-movement intervention (DMI']","['figural fluency task', 'baseline MRI hippocampus-to-cortex volume (HV:CTV) ratio']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",99.0,0.0254886,The baseline HV:CTV ratio was not associated with cognitive changes on that task or with changes in any cognitive domain's Z scores.,"[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Kropacova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Mitterova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Klobusiakova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Brabenec', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Lubomira', 'Initials': 'L', 'LastName': 'Anderkova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Nela', 'Initials': 'N', 'LastName': 'Nemcova-Elfmarkova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Balazova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Rektor', 'Affiliation': 'Multimodal and Functional Imaging Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Grmela', 'Affiliation': 'Department of Health Promotion, Faculty of Sports Studies, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Svobodová', 'Affiliation': 'Department of Gymnastics and Combatives, Faculty of Sports Studies, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Pavlina', 'Initials': 'P', 'LastName': 'Vaculikova', 'Affiliation': 'Department of Gymnastics and Combatives, Faculty of Sports Studies, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Rektorova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00, Brno, Czech Republic. irena.rektorova@fnusa.cz.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-019-02068-y']
214,32203978,Effects of Interleukin-1β Inhibition on Incident Anemia: Exploratory Analyses From a Randomized Trial.,"Background


Inflammatory cytokines, such as interleukin (IL)-1β, alter iron homeostasis and erythropoiesis, resulting in anemia, but whether inhibition of IL-1β can reverse these effects is unclear.
Objective


To determine whether IL-1β inhibition with canakinumab reduces incident anemia and improves hemoglobin levels among those with prevalent anemia.
Design


Exploratory analysis of a randomized controlled trial. (ClinicalTrials.gov: NCT01327846).
Setting


Many clinical sites in 39 countries.
Participants


8683 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants without anemia at trial entry and 1303 with prevalent anemia at trial entry.
Intervention


Random assignment to receive placebo or canakinumab (50, 150, or 300 mg) subcutaneously once every 3 months.
Measurements


Primary outcome was incident anemia (hemoglobin level <130 g/L in men or <120 g/L in women).
Results


Anemia incidence increased with rising baseline levels of high-sensitivity C-reactive protein (hsCRP), and both hsCRP and IL-6 decreased among participants receiving canakinumab compared with the placebo group. During a median follow-up of 3.7 years, participants without baseline anemia who received canakinumab at any dosage had significantly less incident anemia than those who received placebo (hazard ratio, 0.84 [95% CI, 0.77 to 0.93]; P < 0.001). Compared with placebo, the greatest benefits of IL-1β inhibition on incident anemia were observed among participants with the most robust anti-inflammatory response, an effect corroborated in formal mediation analyses. Among those with baseline anemia, canakinumab increased mean hemoglobin levels by 11.3 g/L (P < 0.001) compared with placebo after 2 years of treatment. Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
Limitation


CANTOS was not designed to assess the cause of anemia in individual trial participants.
Conclusion


These exploratory analyses of randomized trial data provide proof of principle that inflammation inhibition, at least through the IL-1β/IL-6 signaling pathway, reduces the incidence of anemia and improves hemoglobin levels in patients with anemia.
Primary Funding Source


Novartis Pharmaceuticals.",2020,"Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
","['Participants\n\n\n8683 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants without anemia at trial entry and 1303 with prevalent anemia at trial entry', 'those with prevalent anemia', '39 countries', 'Incident Anemia', 'patients with anemia']","['Interleukin-1β Inhibition', 'placebo', 'placebo or canakinumab']","['mean hemoglobin levels', 'hsCRP and IL-6', 'hemoglobin levels', 'incident anemia', 'risk for infection', 'incident anemia (hemoglobin level', 'thrombocytopenia and neutropenia']","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C1265848', 'cui_str': 'Inflammatory thrombosis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",,0.720694,"Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
","[{'ForeName': 'Mounica', 'Initials': 'M', 'LastName': 'Vallurupalli', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey (T.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-2945']
215,31138522,Randomized Double-Blind Placebo-Controlled Biomarker Modulation Study of Vitamin D Supplementation in Premenopausal Women at High Risk for Breast Cancer (SWOG S0812).,"Observational studies have reported an inverse association between vitamin D intake and breast cancer risk. We examined whether vitamin D supplementation in high-risk premenopausal women reduces mammographic density (MD), an established breast cancer risk factor. We conducted a multicenter randomized double-blind placebo-controlled trial in premenopausal women at high risk for breast cancer [5-year risk ≥ 1.67%, lifetime risk ≥ 20%, lobular carcinoma  in situ , prior stage 0-II breast cancer, hereditary breast cancer syndrome, or high MD (heterogeneously/extremely dense)], with a baseline serum 25-hydroxyvitamin D [25(OH)D] ≤ 32 ng/mL. Participants were randomized to 12 months of vitamin D3 20,000 IU/week or matching placebo. The primary endpoint was change in MD from baseline to 12 months using the Cumulus technique. Secondary endpoints included serial blood biomarkers [25(OH)D, 1,25-dihydroxyvitamin D (1,25(OH)D), insulin-like growth factor (IGF)-1, IGF-binding protein-3] and MD change at 24 months. Among 208 women randomized, median age was 44.6 years, 84% were white, 33% had baseline 25(OH)D < 20 ng/mL, and 78% had high baseline MD. Comparing the active and placebo groups at 12 months, MD changes were small and did not significantly differ. Mean MD changes at 12 and 24 months were -0.3% and -1.2%, respectively, in the active arm and +1.5% and +1.6% with placebo ( P  > 0.05). We observed a mean change in serum 25(OH)D of +18.9 versus +2.8 ng/mL ( P  < 0.01) and IGF-1 of -9.8 versus -1.8 ng/mL ( P  = 0.28), respectively. At 12 months, MD was positively correlated with serum IGF-1 and IGF-1/IGFBP-3 ( P  < 0.01). This trial does not support the use of vitamin D supplementation for breast cancer risk reduction.",2019,"At 12 months, MD was positively correlated with serum IGF-1 and IGF-1/IGFBP-3 ( P  < 0.01).","['Premenopausal Women at High Risk for Breast Cancer (SWOG S0812', 'high-risk premenopausal women reduces mammographic density (MD), an established breast cancer risk factor', 'premenopausal women at high risk for breast cancer [5-year risk ≥ 1.67%, lifetime risk ≥ 20%, lobular carcinoma  in situ , prior stage 0-II', '208 women randomized, median age was 44.6 years, 84% were white, 33% had baseline 25(OH)D < 20 ng/mL, and 78% had high baseline MD']","['vitamin D supplementation', 'placebo', 'Placebo', 'Vitamin D Supplementation', 'vitamin D3 20,000 IU/week or matching placebo']","['mean change in serum 25(OH)D', 'Mean MD changes', 'serial blood biomarkers [25(OH)D, 1,25-dihydroxyvitamin D (1,25(OH)D), insulin-like growth factor (IGF)-1, IGF-binding protein-3] and MD change', 'MD changes', 'serum 25-hydroxyvitamin D [25(OH)D', 'IGF-1', 'serum IGF-1 and IGF-1/IGFBP-3', 'change in MD']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4047809', 'cui_str': 'At high risk for breast cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1268717', 'cui_str': 'Mammographic Density'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4517511', 'cui_str': 'One point six seven'}, {'cui': 'C0334381', 'cui_str': 'Lobular carcinoma in situ (morphologic abnormality)'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",208.0,0.707928,"At 12 months, MD was positively correlated with serum IGF-1 and IGF-1/IGFBP-3 ( P  < 0.01).","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Crew', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York. kd59@cumc.columbia.edu.'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Terry', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Tehranifar', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Danika L', 'Initials': 'DL', 'LastName': 'Lew', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Yee', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Brown', 'Affiliation': 'William Beaumont Hospital, Beaumont NCORP, Troy, Michigan.'}, {'ForeName': 'Sebastien S', 'Initials': 'SS', 'LastName': 'Kairouz', 'Affiliation': 'Cancer Care Specialists of Central Illinois, Heartland NCORP, Decatur, Illinois.'}, {'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Kuwajerwala', 'Affiliation': 'William Beaumont Hospital, Beaumont NCORP, Troy, Michigan.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Bevers', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Doster', 'Affiliation': 'Anderson Area Cancer Center, Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Anderson, South Carolina.'}, {'ForeName': 'Corrine', 'Initials': 'C', 'LastName': 'Zarwan', 'Affiliation': 'Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kruper', 'Affiliation': 'City of Hope Medical Center, Duarte, California.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ford', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Arun', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Goodman', 'Affiliation': 'Swedish Cancer Institute, Pacific Cancer Research Consortium NCORP, Seattle, Washington.'}, {'ForeName': 'Powel H', 'Initials': 'PH', 'LastName': 'Brown', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston, Texas.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0444']
216,32293965,Re: Pelvic Floor Muscle Training in Radical Prostatectomy: A Randomized Controlled Trial of the Impacts on Pelvic Floor Muscle Function and Urinary Incontinence.,,2020,,['Radical Prostatectomy'],['Re: Pelvic Floor Muscle Training'],['Pelvic Floor Muscle Function and Urinary Incontinence'],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}]",,0.0315816,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001059.03']
217,32203984,Uses and Limitations of the Restricted Mean Survival Time: Illustrative Examples From Cardiovascular Outcomes and Mortality Trials in Type 2 Diabetes.,"The restricted mean survival time (RMST) has been advocated as an alternative or a supplement to the hazard ratio for reporting the effect of an intervention in a randomized clinical trial. The RMST difference allows quantification of the postponement of an outcome during a specified (restricted) interval and corresponds to the difference between the areas under the 2 survival curves for the intervention and control groups. This article presents examples of the use of the RMST in a research and a clinical context. First, the authors demonstrate how the RMST difference can answer research questions about the efficacy of different treatments. Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality. The authors show how these measures may be used to mitigate uncertainty about the efficacy of intensive glucose control. Second, the authors demonstrate how the RMST difference may be used in the setting of a clinical consultation to guide the decision to start or discontinue a treatment. They then discuss the advantages of the RMST over the absolute risk difference, the number needed to treat, and the median survival time difference. They argue that the RMST difference is both easy to interpret and flexible in its application to different settings. Finally, they highlight the major limitations of the RMST, including difficulties in comparing studies of heterogeneous designs and in inferring the long-term effects of treatments using trials of short duration, and summarize the available statistical software for calculating the RMST.",2020,Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality.,"['Type 2 Diabetes', 'adults with type 2 diabetes']",['pharmacologic or strategy-driven glucose-lowering interventions'],"['survival curves', 'mean survival time (RMST', 'median survival time difference']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",,0.0528335,Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality.,"[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kloecker', 'Affiliation': 'Leicester Real World Evidence Unit and Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (D.E.K., K.K., F.Z.).'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (M.J.D.).'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Leicester Real World Evidence Unit and Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (D.E.K., K.K., F.Z.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zaccardi', 'Affiliation': 'Leicester Real World Evidence Unit and Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (D.E.K., K.K., F.Z.).'}]",Annals of internal medicine,['10.7326/M19-3286']
218,30689825,Association of acute kidney injury and bleeding events with mortality after radial or femoral access in patients with acute coronary syndrome undergoing invasive management: secondary analysis of a randomized clinical trial.,"AIMS


In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear.
METHODS AND RESULTS


We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31-0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26-0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49).
CONCLUSION


The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding.",2019,"Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49).
","['adults with acute coronary syndrome undergoing coronary intervention', 'patients with acute coronary syndrome undergoing invasive management']",['radial or femoral access'],"['risk of bleeding, acute kidney injury (AKI', 'bleeding to death']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.496044,"Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49).
","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rothenbühler', 'Affiliation': 'CTU Bern, and Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Odutayo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, 30 Bond Street, Toronto, Ontario, Canada.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Frigoli', 'Affiliation': 'CTU Bern, and Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'Coronary Care Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, Pavia, Italy.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium, and Faculty of Medicine and Life Sciences, University of Hasselt, Martelarenlaan 42, Hasselt, Belgium.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Turturo', 'Affiliation': 'Division of Cardiology, P.O. Di Venere, Via Ospedale di Venere 1, Bari, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Moretti', 'Affiliation': 'Division of Cardiology, Mazzoni Hospital, Via Degli Iris, Ascoli Piceno, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Amico', 'Affiliation': 'Cardiology Unit, S. Elia Hospital, Via Luigi Russo 6, Caltanissetta, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Uguccioni', 'Affiliation': 'Interventional Cardiology, Ospedali Riuniti Marche Nord, Piazzale Cinelli 4, Pesaro, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Contarini', 'Affiliation': 'Interventional Cardiology Unit, Umberto I Hospital, Via Testaferrata 1, Siracusa, Italy.'}, {'ForeName': 'Joan Antoni', 'Initials': 'JA', 'LastName': 'Gómez-Hospital', 'Affiliation': ""Heart Diseases Institute, Bellvitge University Hospital, Feixa Llarga s/n, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Mainar', 'Affiliation': 'Department of Cardiology, Hospital General of Alicante, Pintor Baeza 11, Alicante, Spain.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Creaco', 'Affiliation': 'Cardiology Unit, Gravina Hospital, Via Portosalvo 9, Caltagirone, Italy.'}, {'ForeName': 'Anna Sonia', 'Initials': 'AS', 'LastName': 'Petronio', 'Affiliation': 'Unit of Interventional Cardiology, Cardiothoracic and Vascular Department, Ospedale di Cisanello, University of Pisa, Via Paradisa 2, Pisa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cremonesi', 'Affiliation': 'Cardiovascular Department, Humanitas Gavazzeni Hospital, Via M. Gavazzeni 21, Bergamo, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tamburino', 'Affiliation': 'Cardiology Division, C.A.S.T. Policlinico University Hospital, Cardio-Thorax-Vascular and Transplant Department, Via S. Sofia 76, Catania, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Fresco', 'Affiliation': 'Cardiology Unit, Azienda Sanitaria Universitaria Integrata di Udine, Piazzale S. Maria della Misericordia 15, Udine, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bonmassari', 'Affiliation': ""Division of Cardiology, Santa Chiara Hospital, Largo Medaglie D'oro 9, Trento, Italy.""}, {'ForeName': 'José Francisco', 'Initials': 'JF', 'LastName': 'Díaz Fernández', 'Affiliation': 'Interventional Cardiology Department, Juan Ramon Jimenez University Hospital, Ronda norte sn, Huelva, Spain.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Romagnoli', 'Affiliation': 'Department of Cardiology, Fondazione Policlinico Universitario A. Gemelli, Largo Agostino Gemelli 8, Rome, Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyersmann', 'Affiliation': 'Institute of Statistics, Ulm University, Helmholtzstrasse 20, Ulm, Germany.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'CTU Bern, and Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, 30 Bond Street, Toronto, Ontario, Canada.""}]",European heart journal,['10.1093/eurheartj/ehy860']
219,32203980,Iron Chelation in Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes: A Randomized Trial.,"Background


Iron chelation therapy (ICT) in patients with lower-risk myelodysplastic syndromes (MDS) has not been evaluated in randomized studies.
Objective


To evaluate event-free survival (EFS) and safety of ICT in iron-overloaded patients with low- or intermediate-1-risk MDS.
Design


Multicenter, randomized, double-blind, placebo-controlled trial (TELESTO). (ClinicalTrials.gov: NCT00940602).
Setting


60 centers in 16 countries.
Participants


225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities.
Intervention


Deferasirox dispersible tablets (10 to 40 mg/kg per day) (n = 149) or matching placebo (n = 76).
Measurements


The primary end point was EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first.
Results


Median time on treatment was 1.6 years (interquartile range [IQR], 0.5 to 3.1 years) in the deferasirox group and 1.0 year (IQR, 0.6 to 2.0 years) in the placebo group. Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]). Adverse events occurred in 97.3% of deferasirox recipients and 90.8% of placebo recipients. Exposure-adjusted incidence rates of adverse events (≥15 events per 100 patient treatment-years) in deferasirox versus placebo recipients, respectively, were 24.7 versus 23.9 for diarrhea, 21.8 versus 18.7 for pyrexia, 16.7 versus 22.7 for upper respiratory tract infection, and 15.9 versus 0.9 for increased serum creatinine concentration.
Limitations


The protocol was amended from a phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants. There was differential follow-up between treatment groups.
Conclusion


The findings support ICT in iron-overloaded patients with low- to intermediate-1-risk MDS, with longer EFS compared with placebo and a clinically manageable safety profile. Therefore, ICT may be considered in these patients.
Primary Funding Source


Novartis Pharma AG.",2020,"Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]).","['Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes', 'Participants\n\n\n225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities', 'Setting\n\n\n60 centers in 16 countries', 'patients with lower-risk myelodysplastic syndromes (MDS', 'iron-overloaded patients with low- or intermediate-1-risk MDS', 'phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants']","['matching placebo', 'placebo', '\n\n\nIron chelation therapy (ICT', 'ICT', 'Iron Chelation']","['adverse events', 'EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first', 'Adverse events', 'serum creatinine concentration', 'Median EFS']","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439284', 'cui_str': 'fmol/mL'}, {'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0282193', 'cui_str': 'Iron Overload'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C4324477', 'cui_str': 'Transformation to acute myeloid leukaemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",225.0,0.554516,"Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]).","[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Angelucci', 'Affiliation': 'Hematology and Transplant Center, IRCCS Ospedale Policlinico San Martino, Genova, Italy (E.A.).'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (J.L.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Greenberg', 'Affiliation': 'Stanford University Medical Center, Stanford, California (P.G.).'}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Institute of Hematology, First Affiliated Hospital of Soochow University, Suzhou, China (D.W.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Shandong University, Jinan, China (M.H.).'}, {'ForeName': 'Efreen Horacio', 'Initials': 'EH', 'LastName': 'Montano Figueroa', 'Affiliation': 'Department of Hematology, Hospital General de México, Mexico City, Mexico (E.H.M.).'}, {'ForeName': 'Maria Guadalupe', 'Initials': 'MG', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology, Hospital de Especialidades, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico (M.G.R.).'}, {'ForeName': 'Xunwei', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (X.D., J.G.).'}, {'ForeName': 'Jagannath', 'Initials': 'J', 'LastName': 'Ghosh', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (X.D., J.G.).'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland (M.I.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, Texas (G.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0916']
220,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES


Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance.
SUBJECTS/METHODS


Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months.
RESULTS


At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
CONCLUSIONS


Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
221,32063397,"The long-term safety and efficacy of vestronidase alfa, rhGUS enzyme replacement therapy, in subjects with mucopolysaccharidosis VII.","Vestronidase alfa (recombinant human beta-glucuronidase) is an enzyme replacement therapy (ERT) for Mucopolysaccharidosis (MPS) VII, a highly heterogeneous, ultra-rare disease. Twelve subjects, ages 8-25 years, completed a Phase 3, randomized, placebo-controlled, blind-start, single crossover study (UX003-CL301; NCT02377921), receiving 24-48 weeks of vestronidase alfa 4 mg/kg IV. All 12 subjects completed the blind-start study, which showed significantly reduced urinary glycosaminoglycans (GAG) and clinical improvement in a multi-domain responder index, and enrolled in a long-term, open-label, extension study (UX003-CL202; NCT02432144). Here, we report the final results of the extension study, up to an additional 144 weeks after completion of the blind-start study. Three subjects (25%) completed all 144 weeks of study, eight subjects (67%) ended study participation before Week 144 to switch to commercially available vestronidase alfa, and one subject discontinued due to non-compliance after receiving one infusion of vestronidase alfa in the extension study. The safety profile of vestronidase alfa in the extension study was consistent with observations in the preceding blind-start study, with most adverse events mild to moderate in severity. There were no treatment or study discontinuations due to AEs and no noteworthy changes in a standard safety chemistry panel. Out of the eleven subjects who tested positive for anti-drug antibodies at any time during the blind-start or extension study, including the baseline assessment in the blind-start study, seven subjects tested positive for neutralizing antibodies and all seven continued to demonstrate a reduction in urinary GAG levels. There was no association between antibody formation and infusion associated reactions. Subjects receiving continuous vestronidase alfa treatment showed a sustained urinary GAG reduction and clinical response evaluated using a multi-domain responder index that includes assessments in pulmonary function, motor function, range of motion, mobility, and visual acuity. Reduction in fatigue was also maintained in the overall population. As ERT is not expected to cross the blood brain barrier, limiting the impact on neurological signs of disease, and not all subjects presented with neurological symptoms, outcomes related to central nervous system pathology are not focused on in this report. Results from this study show the long-term safety and durability of clinical efficacy in subjects with MPS VII with long-term vestronidase alfa treatment.",2020,"All 12 subjects completed the blind-start study, which showed significantly reduced urinary glycosaminoglycans (GAG) and clinical improvement in a multi-domain responder index, and enrolled in a long-term, open-label, extension study (UX003-CL202; NCT02432144).","['Twelve subjects, ages 8-25\xa0years', 'subjects with mucopolysaccharidosis VII', 'eleven subjects who tested positive for anti-drug antibodies at any time during the blind-start or extension study', 'subjects with MPS VII with long-term vestronidase alfa treatment', 'Three subjects (25%) completed all 144\xa0weeks of study, eight subjects (67%) ended study participation before Week 144 to switch to commercially available vestronidase alfa, and one subject discontinued due to non-compliance after receiving one infusion of vestronidase alfa in the extension study']","['placebo', 'Vestronidase alfa (recombinant human beta-glucuronidase', 'vestronidase alfa, rhGUS enzyme replacement therapy', 'vestronidase alfa 4\xa0mg/kg IV']","['antibody formation and infusion associated reactions', 'pulmonary function, motor function, range of motion, mobility, and visual acuity', 'Reduction in fatigue', 'sustained urinary GAG reduction and clinical response', 'urinary glycosaminoglycans (GAG) and clinical improvement', 'urinary GAG levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085132', 'cui_str': 'GUSB Deficiency'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4519728', 'cui_str': 'Vestronidase alfa'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4519728', 'cui_str': 'Vestronidase alfa'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0017776', 'cui_str': 'beta-D-Glucuronoside glucuronosohydrolase'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3.0,0.0538877,"All 12 subjects completed the blind-start study, which showed significantly reduced urinary glycosaminoglycans (GAG) and clinical improvement in a multi-domain responder index, and enrolled in a long-term, open-label, extension study (UX003-CL202; NCT02432144).","[{'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': ""Division of Metabolic Disorders, Children's Hospital of Orange County, 1201 W. La Veta Ave, Orange, CA 92868, United States; Department of Pediatrics, University of California-Irvine, Orange, CA 92868, United States. Electronic address: RaWang@choc.org.""}, {'ForeName': 'José Francisco', 'Initials': 'JF', 'LastName': 'da Silva Franco', 'Affiliation': 'Hospital Sabara, Av. Angélica, 1987 Consolação, São Paulo, SP, 01227-200, Brazil; Centro de Biotecnologia /Instituto de Pesquisas de Energéticas e Nucleares IPEN/USP, Av 11 de junho 364, Casa 3, Vila Clementino, São Paulo, 04041-001, Brazil.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'López-Valdez', 'Affiliation': 'Centenario Hospital Miguel Hidalgo, Av. Gomez Morin S/N, La estación- La Alameda, Aguascalientes, Ags 20259, Mexico.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Martins', 'Affiliation': 'Centro Hospitalar Do Porto, Hospital de Santo António, Porto, Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal.'}, {'ForeName': 'Vernon Reid', 'Initials': 'VR', 'LastName': 'Sutton', 'Affiliation': ""Department of Molecular & Human Genetics Baylor College of Medicine & Texas Children's Hospital, Mail Stop BCM225, Houston, TX 77030, United States. Electronic address: vrsutton@texaschildrens.org.""}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': 'Department of Pediatrics, and Experimental and Clinical Pharmacology, University of Minnesota, East Building, 2450 Riverside Ave, Minneapolis, MN 55454, United States. Electronic address: whitley@umn.edu.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Ct, Novato, CA 94949, United States. Electronic address: LZhang@ultragenyx.com.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Cimms', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Ct, Novato, CA 94949, United States. Electronic address: TCimms@ultragenyx.com.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Marsden', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Ct, Novato, CA 94949, United States. Electronic address: DMarsden@ultragenyx.com.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Jurecka', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Ct, Novato, CA 94949, United States. Electronic address: AJurecka@ultragenyx.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, 744 52nd St, Oakland, CA 94609, United States. Electronic address: Paul.Harmatz@UCSF.edu.""}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.01.003']
222,31800425,Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels.,"BACKGROUND


Tranexamic acid (TXA) is an antifibrinolytic drug. Topical administration of TXA during total knee arthroplasty (TKA) is favored for certain patients because of concerns about thrombotic complications, despite a lack of supporting literature. We compared local and systemic levels of thrombogenic markers, interleukin (IL)-6, and TXA between patients who received intravenous (IV) TXA and those who received topical TXA.
METHODS


Seventy-six patients scheduled for TKA were enrolled in this randomized double-blinded study. The IV group received 1.0 g of IV TXA before tourniquet inflation and again 3 hours later; a topical placebo was administered 5 minutes before final tourniquet release. The topical group received an IV placebo before tourniquet inflation and again 3 hours later; 3.0 g of TXA was administered topically 5 minutes before final tourniquet release. Peripheral and wound blood samples were collected to measure levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis), prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), IL-6, and TXA.
RESULTS


At 1 hour after tourniquet release, systemic PAP levels were comparable between the IV group (after a single dose of IV TXA) and the topical group. At 4 hours after tourniquet release, the IV group had lower systemic PAP levels than the topical group (mean and standard deviation, 1,117.8 ± 478.9 µg/L versus 1,280.7 ± 646.5 µg/L; p = 0.049), indicative of higher antifibrinolytic activity after the second dose. There was no difference in PF1.2 levels between groups, indicating that there was no increase in thrombin generation. The IV group had higher TXA levels at all time points (p < 0.001). Four hours after tourniquet release, wound blood IL-6 and TXA levels were higher than systemic levels in both groups (p < 0.001). Therapeutic systemic TXA levels (mean, 7.2 ± 7.4 mg/L) were noted in the topical group. Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
CONCLUSIONS


Given that therapeutic levels were reached with topical TXA and the lack of a major difference in the mechanism of action, coagulation, and fibrinolytic profile between topical TXA and a single dose of IV TXA, it may be a simpler protocol for institutions to adopt the use of a single dose of IV TXA when safety is a concern.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
","['Seventy-six patients scheduled for TKA', 'Total Knee Replacement', 'total knee arthroplasty (TKA']","['Tranexamic acid (TXA', 'IV TXA', 'IV placebo', 'intravenous (IV) TXA', 'topical placebo', 'Topical and Intravenous Tranexamic Acid', 'topical TXA', 'TXA']","['thrombin generation', 'antifibrinolytic activity', 'local and systemic levels of thrombogenic markers, interleukin (IL)-6, and TXA', 'higher TXA levels', 'wound blood IL-6 and TXA levels', 'systemic PAP levels', 'Peripheral and wound blood samples', 'mechanism of action, coagulation, and fibrinolytic profile', 'Calculated blood loss and the length of the hospital stay', 'Therapeutic systemic TXA levels', 'PF1.2 levels', 'Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels', 'levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis), prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), IL-6, and TXA']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0003304', 'cui_str': 'Antifibrinolysins'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0005768'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1524059', 'cui_str': 'mode of action'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0072436', 'cui_str': 'prothrombin activation fragment F1+2'}]",76.0,0.330857,"Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
","[{'ForeName': 'Kethy M', 'Initials': 'KM', 'LastName': 'Jules-Elysee', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tseng', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Sculco', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Lila R', 'Initials': 'LR', 'LastName': 'Baaklini', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'McLawhorn', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Pickard', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'WeiGe', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Cross', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mayman', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00258']
223,32285553,Effect of transdermal estradiol therapy on bone mineral density of amenorrheic female athletes.,"BACKGROUND


The effects of transdermal estradiol treatment (HT) in amenorrheic athletes (AA) with low body weight (BW) and low bone mineral density (BMD) are unknown.
PURPOSE


To investigate whether HT increases BMD in AA with low BW and to compare the results with levels in AA who have recovered spontaneous menstruation (SM).
METHODS


Female athletes (n = 151) were recruited at the Japan Institute of Sports Sciences and the University of Tokyo. All participants were divided into four groups: an AA group (untreated group) (n = 36), a HT group (n = 55), a SM group (n = 21), and an eumenorrheic athletes (EA) group (n = 39). Height, body weight, blood tests, and dual-energy X-ray absorptiometry were measured at baseline and after 12 months. The HT group was treated daily for 12 months with transdermal estrogen therapy. In addition, participants received oral progestin for 7 days once every 3 months.
RESULTS


After 12 months, BMD in the AA group was significantly lower than at baseline; however, BMD in the other three groups was significantly higher than at baseline. The ratio of the change in BMD values before and after 12 months was -1.6 ± 3.2% for the AA group, 5.3 ± 8.7% for the HT group, 11.1 ± 8.9% for the SM group, and 2.3 ± 5.7% for the EA group. The rate of change in BMD values in the SM group was greater than that in the HT group.
CONCLUSION


HT increased BMD in AA with low BW, and the increase in those with SM was greater than that in those treated with HT.",2020,"After 12 months, BMD in the AA group was significantly lower than at baseline; however, BMD in the other three groups was significantly higher than at baseline.","['amenorrheic athletes (AA) with low body weight (BW) and low bone mineral density (BMD', 'amenorrheic athletes', 'Female athletes (n=151) were recruited at the Japan Institute of Sports Sciences and the University of Tokyo']","['transdermal estrogen therapy', 'transdermal estradiol treatment (HT', 'transdermal estradiol therapy', 'eumenorrheic athletes (EA', 'SM', 'oral progestin', 'HT']","['bone mineral density', 'rate of change in BMD values', 'BMD values', 'HT increased BMD', 'BMD', 'Height, body weight, blood tests and dual-energy X-ray absorptiometry']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0029464', 'cui_str': 'Osteosclerosis'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",151.0,0.0364514,"After 12 months, BMD in the AA group was significantly lower than at baseline; however, BMD in the other three groups was significantly higher than at baseline.","[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Nose-Ogura', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yoshino', 'Affiliation': 'Department of Obstetrics and Gynecology, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Kanatani', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Dohi', 'Affiliation': 'Sports Medical Center, Japan Institute of Sports Sciences, Tokyo, Japan.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Tabei', 'Affiliation': 'Department of Radiology, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hiraike', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Sports Medical Center, Japan Institute of Sports Sciences, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo, Japan.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13679']
224,32179197,Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial.,"OBJECTIVES


To investigate the effects of lower limb strength training in addition to neuromuscular exercise and education (ST + NEMEX-EDU) compared to neuromuscular exercise and education alone (NEMEX-EDU) on self-reported physical function in patients with knee osteoarthritis (KOA).
DESIGN


Patient-blinded, parallel-group randomized controlled trial (RCT).
METHODS


The trial included 90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement. Both groups exercised twice weekly for 12 weeks. Additional strength training consisted of a single, fatiguing knee extension set (30-60RM) before four sets of leg-press (8-12RM). Primary outcome was the between-group difference on the subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOS ADL ) at 12 weeks. Secondary outcomes included KOOS symptoms, pain, function in sport and recreation, and quality of life, 40 m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events.
RESULTS


There was no statistically significant between-group difference in KOOS ADL  at 12-weeks; adjusted mean difference -1.15 (-6.78 to 4.48). Except for the stair climb test, which demonstrated an adjusted mean difference of 1.15 (0.09-2.21) in favor of ST + NEMEX-EDU, all other outcomes showed no statistically significant between-group differences. Neither group improved leg extension power.
CONCLUSION


The addition of lower-limb strength training, using a low-dose approach, to neuromuscular exercise and education carried no additional benefits on self-reported physical function or on most secondary outcomes. Both groups displayed similar improvements at 12-week follow-up. Hence, the current low-dose strength training approach provided no additional clinical value in this group of KOA patients. Trial identifier (ClinicalTrials.gov): NCT03215602.",2020,There was no statistically significant between-group difference in KOOS ADL  at 12-weeks; adjusted mean difference,"['patients with knee osteoarthritis (KOA', '90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement', 'patients with knee osteoarthritis in secondary care ']","['neuromuscular exercise and education (ST+NEMEX-EDU', 'Low-dose strength training', 'lower limb strength training', 'neuromuscular exercise and education', 'neuromuscular exercise and education alone (NEMEX-EDU']","['KOOS ADL', 'KOOS symptoms, pain, function during sport and recreation, and quality of life, 40m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events', 'subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOS ADL ', 'leg extension power']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2927798', 'cui_str': 'Nemex'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0034380'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",90.0,0.118503,There was no statistically significant between-group difference in KOOS ADL  at 12-weeks; adjusted mean difference,"[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Holm', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Slagelse & Næstved, Denmark. Electronic address: pamh@regionsjaelland.dk.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Schrøder', 'Affiliation': 'Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals, Næstved, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wernbom', 'Affiliation': 'Center for Health and Performance, Department of Food and Nutrition and Sport Science, University of Gothenburg, Gothenburg, Sweden; Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Slagelse & Næstved, Denmark.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.02.839']
225,32189096,A Brief Clinic-Based Intervention to Reduce Alcohol Misuse and Sexual Risk Behavior in Young Women: Results from an Exploratory Clinical Trial.,"This exploratory trial determined the feasibility, acceptability, and preliminary efficacy of a brief intervention (BI), supplemented with text messaging and a curated Web site, on alcohol use and sexual risk behavior among young women. Young women seeking care at a reproductive health clinic were screened for alcohol misuse and sexual risk behavior. Those who screened positive and who agreed to participate (N = 48; M = 22.67 years) were randomized to either (a) a brief in-person session during which personalized feedback regarding alcohol use and sexual risk taking was provided and discussed, or (b) a control condition. Feasibility was assessed by recruitment and retention rates. Acceptability was assessed with participant ratings of their intervention. Efficacy was measured using self-reported alcohol use and sexual behavior at baseline and during a 3-month follow-up. We supplemented the quantitative data with qualitative data from semi-structured interviews. Feasibility data indicated that 64% of eligible women agreed to participate, 74% of eligible women were enrolled, and 86% of enrolled women were retained through follow-up. Acceptability data showed that women who received the BI reported strong satisfaction with their intervention (M = 4.65 vs. 3.98 on a five-point scale) and also reported that text messaging was helpful (M = 4.73 on a seven-point scale) and acceptable (M = 5.27 on a seven-point scale). Qualitative data provided additional support for BI feasibility and acceptability. Efficacy data showed that women in both conditions reduced alcohol use and sexual risk behavior over time; women who received the BI reduced their maximum daily alcohol intake more than controls (BI from 7.68 to 4.82 standard drinks vs. control from 6.48 to 5.65; Wald χ 2  = 4.93, p < .05). Women in the BI reported fewer occasions of condomless sex (median = 2.50) than controls (median = 5.00) at the follow-up, but this difference was not statistically significant (OR = 0.61, 95% CI [0.32, 1.15]). A brief intervention, supplemented with text messaging and a Web site, that targeted alcohol use and sexual behavior was feasible and acceptable to young women and led to lower levels of alcohol misuse and sexual risk behavior.",2020,"Efficacy data showed that women in both conditions reduced alcohol use and sexual risk behavior over time; women who received the BI reduced their maximum daily alcohol intake more than controls (BI from 7.68 to 4.82 standard drinks vs. control from 6.48 to 5.65; Wald χ 2  = 4.93, p < .05).","['Young women seeking care at a reproductive health clinic were screened for alcohol misuse and sexual risk behavior', 'Those who screened positive and who agreed to participate (N\u2009=\u200948; M\u2009=\u200922.67\xa0years', 'Young Women', 'young women', '64% of eligible women agreed to participate, 74% of eligible women were enrolled, and 86% of enrolled women']","['brief in-person session during which personalized feedback regarding alcohol use and sexual risk taking was provided and discussed, or (b) a control condition', 'brief intervention (BI), supplemented with text messaging and a curated Web site']","['Acceptability', 'alcohol use and sexual risk behavior', 'maximum daily alcohol intake', 'self-reported alcohol use and sexual behavior', 'Alcohol Misuse and Sexual Risk Behavior', 'Efficacy', 'condomless sex']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",,0.0400899,"Efficacy data showed that women in both conditions reduced alcohol use and sexual risk behavior over time; women who received the BI reduced their maximum daily alcohol intake more than controls (BI from 7.68 to 4.82 standard drinks vs. control from 6.48 to 5.65; Wald χ 2  = 4.93, p < .05).","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Carey', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA. Michael_Carey@brown.edu.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Rich', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Alyssa L', 'Initials': 'AL', 'LastName': 'Norris', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Krieger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Gavarkovs', 'Affiliation': 'Department of Behavioral and Social Science, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Kaplan', 'Affiliation': 'Department of Clinical Research, Planned Parenthood of Southern New England, New Haven, CT, USA.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Guthrie', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Department of Behavioral and Social Science, School of Public Health, Brown University, Providence, RI, USA.'}]",Archives of sexual behavior,['10.1007/s10508-020-01635-9']
226,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE


In 2014, our institution launched a randomized controlled trial (RCT) comparing rapid genome sequencing (GS) to standard clinical evaluations of infants with suspected genetic disorders. This study aimed to understand parental response to the use of GS for their newborn babies.
METHODS


Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information. We also collected information about participants' genetic literacy, genetic knowledge, numeracy, and symptoms of anxiety and depression.
RESULTS


The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial. The 12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information. Some reported the diagnosis led to changes in medical care. Participants showed understanding of some of the psychological risks of GS. For example, 21 (91.3%) agreed or strongly agreed that genetic testing could reveal disturbing results.
CONCLUSIONS


Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
227,32163659,An Alternative Method for Anatomy Training: Immersive Virtual Reality.,"The aim of this study was to investigate the effect of immersive three-dimensional (3D) interactive virtual reality (VR) on anatomy training in undergraduate physical therapy students. A total of 72 students were included in the study. The students were randomized into control (n = 36) and VR (n = 36) group according to the Kolb Learning Style Inventory, sex, and Purdue Spatial Visualization Test Rotations (PSVT-R). Each student completed a pre-intervention and post-intervention test, consisting of 15 multiple-choice questions. There was no significant difference between the two groups in terms of age, sex, Kolb Learning Style Inventory distribution, and the PSVT-R (P > 0.05). The post-test scores were significantly higher compared to pre-test scores in both the VR group (P < 0.001) and the control group (P < 0.001). The difference between the pre-test and post-test results was found to be significantly higher in favor of the VR group (P < 0.001). In this study, anatomy training with a 3D immersive VR system was found to be beneficial. These results suggest that VR systems can be used as an alternative method to the conventional anatomy training approach for health students.",2020,The post-test scores were significantly higher compared to pre-test scores in both the VR group (P < 0.001) and the control group (P < 0.001).,"['A total of 72 students were included in the study', 'undergraduate physical therapy students', 'health students']","['Kolb Learning Style Inventory, sex, and Purdue spatial visualization test rotations (PSVT-R', 'immersive three-dimensional (3D) interactive virtual reality (VR']","['age, sex, Kolb Learning Style Inventory distribution, and the PSVT-R']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]",72.0,0.0126629,The post-test scores were significantly higher compared to pre-test scores in both the VR group (P < 0.001) and the control group (P < 0.001).,"[{'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Kurul', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Muhammed Nur', 'Initials': 'MN', 'LastName': 'Ögün', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Neriman Narin', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'Avci', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Beyza', 'Initials': 'B', 'LastName': 'Yazgan', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}]",Anatomical sciences education,['10.1002/ase.1959']
228,32290933,[Effects of nutrition package on intestinal flora of infants by high-throughput sequencing].,"OBJECTIVE


To investigate the effect of nutrition package on intestinal flora of infants aged 6-24 months.
METHODS


A total of 118 infants in Songxian County and Ruyang County of Henan Province, 60 infants in Songxian County with nutrition package coverage, and 58 infants in Ruyang County of the control county were selected for the long-term effects of early childhood nutrition package intervention project in 2018. All infant faeces were collected, and the composition and abundance of intestinal flora were analyzed and compared by high-throughput sequencing technology.
RESULTS


The Alpha diversity of intestinal flora in the nutrition package intervention group was significantly higher than that in the control group. Firmicutes were on the rise in the nutrition package intervention group of infants aged 6-24 months. The abundance of Prevotella in the intervention group was significantly lower than that in the control group. The abundance of Faecalibacterium and Bacteroides in the nutrition package treatment group for infants aged 12 to 17 months was significantly higher than that of the control group, while the abundance of Bifidobacterium and Prevotella was significantly lower than that of the control group. Lactobacillus was significantly less abundant in the 18-24 month old infant nutrition package intervention group than in the control group.
CONCLUSION


Nutrition package can improve the diversity of intestinal flora, also play an important role in promoting the balance of intestinal flora of infants.",2020,"The abundance of Faecalibacterium and Bacteroides in the nutrition package treatment group for infants aged 12 to 17 months was significantly higher than that of the control group, while the abundance of Bifidobacterium and Prevotella was significantly lower than that of the control group.","['118 infants in Songxian County and Ruyang County of Henan Province, 60 infants in Songxian County with nutrition package coverage, and 58 infants in Ruyang County of the control county were selected for the long-term effects of early childhood nutrition package intervention project in 2018', 'infants aged 6-24 months', 'infants by high-throughput sequencing']","['Nutrition package', 'nutrition package']","['abundance of Faecalibacterium and Bacteroides', 'abundance of Prevotella', 'composition and abundance of intestinal flora', 'Alpha diversity of intestinal flora', 'abundance of Bifidobacterium and Prevotella', 'Lactobacillus']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023983', 'cui_str': 'Effects, Longterm'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]",,0.0208984,"The abundance of Faecalibacterium and Bacteroides in the nutrition package treatment group for infants aged 12 to 17 months was significantly higher than that of the control group, while the abundance of Bifidobacterium and Prevotella was significantly lower than that of the control group.","[{'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}, {'ForeName': 'Zhaolong', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Huo', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhuo', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': ""National Institute for Nutrition and Health, China CDC, Key Laboratory of Trace Element Nutrition, National Health Commission of the People's Republic of China, Beijing 100050, China.""}]",Wei sheng yan jiu = Journal of hygiene research,['10.19813/j.cnki.weishengyanjiu.2020.02.011']
229,32293738,Does an effective shoulder injury prevention program affect risk factors in handball? A randomized controlled study.,"BACKGROUND


Shoulder problems are common in handball, but injury risk reduction is possible by implementing a prevention program. However, player compliance to the program remains a challenge, with feedback from players that the program is too time consuming.
AIM


To develop a more efficient program, we aimed to assess the effect of the Oslo Sports Trauma Research Center shoulder injury prevention program on external rotation (ER) strength and internal rotation (IR) range of motion (ROM), considered to represent key risk factors for injury.
METHODS


Four youth handball teams (three females, one males, 57 players, mean age 17.1 years) were randomized to an intervention or control group. The intervention program was conducted three times per week as a part of handball warm-up for 18 weeks, supervised by physical therapists. The main outcome variables were the between-group differences in ER strength and IR ROM change from baseline to postintervention. Isometric ER strength was measured with a handheld dynamometer and IR ROM with a digital goniometer.
RESULTS


Mean dominant shoulder isometric ER strength increased both in the intervention (10%) and the control group (6%) during the intervention, but there was no significant group by time interaction (group difference: 0.06 N/kg (95% CI: -0.04 to 0.17). IR ROM did not change in either group during the intervention.
CONCLUSION


The Oslo Sports Trauma Research Center shoulder injury prevention program did not affect the risk factors ER strength and IR ROM. The preventive effect of the program must therefore be due to other factors.",2020,"Mean dominant shoulder isometric ER strength increased both in the intervention (10%) and the control group (6%) during the intervention, but there was no significant group by time interaction (group difference: 0.06 N/kg (95% CI: -0.04 to 0.17).","['Four youth handball teams (three female, one male, 57 players, mean age 17.1 yrs']",[],"['external rotation (ER) strength and internal rotation (IR) range of motion (ROM', 'Isometric ER strength', 'risk factors ER strength and IR ROM', 'time interaction', 'ER strength and IR ROM change', 'IR ROM', 'Mean dominant shoulder isometric ER strength']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",,0.0381925,"Mean dominant shoulder isometric ER strength increased both in the intervention (10%) and the control group (6%) during the intervention, but there was no significant group by time interaction (group difference: 0.06 N/kg (95% CI: -0.04 to 0.17).","[{'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Fredriksen', 'Affiliation': 'Oslo Sports Trauma Research Center, Sports Medicine Department, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cools', 'Affiliation': 'Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Roald', 'Initials': 'R', 'LastName': 'Bahr', 'Affiliation': 'Oslo Sports Trauma Research Center, Sports Medicine Department, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Myklebust', 'Affiliation': 'Oslo Sports Trauma Research Center, Sports Medicine Department, Norwegian School of Sport Sciences, Oslo, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13674']
230,31722153,Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.,"BACKGROUND


Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (""ovarian"") cancer is widely practiced but has not been evaluated in phase 3 investigation.
METHODS


We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival.
RESULTS


A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery.
CONCLUSIONS


In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).",2019,"The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively).","['patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by', 'women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (""ovarian"") cancer', '485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone', 'We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive', 'Recurrent Ovarian Cancer']","['Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin', 'Platinum-based chemotherapy with bevacizumab', 'platinum-based chemotherapy or to receive platinum-based chemotherapy alone', 'chemotherapy', 'bevacizumab', 'bevacizumab maintenance']","['Surgical morbidity', 'quality of life', 'hazard ratio for disease progression or death', 'overall survival', 'Complete gross resection', 'median overall survival', 'median progression-free survival', 'hazard ratio for death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0034380'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",485.0,0.29698,"The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Enserro', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sabbatini', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Sang-Yoon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Joo-Hyun', 'Initials': 'JH', 'LastName': 'Nam', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Casey', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rubin', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Davidson', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohn', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}]",The New England journal of medicine,['10.1056/NEJMoa1902626']
231,32157294,"Effects of quality grade and intramuscular location on beef semitendinosus muscle fiber characteristics, NADH content, and color stability.","The objective of this study was to determine the impact of quality grade and steak location on color stability of semitendinosus (ST) steaks during a 9-d refrigerated study. Twenty-one ST muscles (12 Choice and 9 Select) were purchased from a commercial beef packing plant and fabricated into twelve 2.54-cm thick steaks per muscle. Steaks 1, 6, and 12 were designated for immunohistochemistry while remaining steak locations of proximal (steaks 2 to 4), middle (5 to 8), and distal (9 to 11) were randomly assigned to 0, 4, or 9 d of simulated retail display. Surface color attributes of day-9 steaks were recorded daily by a visual color panel and spectrophotometer. On days 0, 4, and 9 of display, steaks were analyzed for metmyoglobin reducing ability (MRA) and oxygen consumption (OC). Grade × day of display (DOD) interactions were detected for L*, a*, surface oxymyoglobin (OMb) and metmyoglobin (MMb) percentages, and visual panel surface redness and discoloration scores (P ≤ 0.02); however, no Grade × DOD interactions were observed for MRA or OC (P > 0.17). There were location main effect (LOC) × DOD interactions for L*, a*, surface MMb, visual panel surface redness and discoloration, and MRA (P ≤ 0.02). Distal steaks had lower L* values compared with the other locations (P < 0.01), which coincided with steaks being rated visually darker red (P < 0.01). Proximal steaks had greater a* values and had less surface discoloration than middle steaks (P < 0.05), which had an increased percentage of surface MMb (P ≤ 0.04). Distal and proximal steaks had increased MRA compared with middle steaks on days 0 and 4 (P < 0.05), and distal steaks had greater OC than the other locations throughout display (P < 0.01). There were fewer type I fibers at the proximal end with a greater percentage located at the middle and distal ends, and an increased percentage of type IIX fibers at the middle and proximal locations (P ≤ 0.01). Less type IIA fibers were detected at the middle LOC compared with the other two locations (P < 0.10). Larger type I, IIA, and IIX fibers were located at the proximal and middle locations compared with the distal LOC (P < 0.01). ST color and color-stability characteristics were influenced by DOD and LOC, which may partially be explained by differences in fiber types among locations.",2020,Less type IIA fibers were detected at the middle location compared to the other two locations (P < 0.10).,[],[],"['Grade × DOD interactions', 'percentage of surface MMb', 'percentage of type IIX fibers', 'surface MMb, visual panel surface redness and discoloration, and MRA', 'metmyoglobin reducing ability (MRA) and oxygen consumption (OC', 'surface discoloration', 'Semitendinosus color and color-stability characteristics', 'surface oxymyoglobin (OMb) and metmyoglobin (MMb) percentages, and visual panel surface redness and discoloration scores', 'Less type IIA fibers', 'MRA', 'I, IIA, and IIX fibers', 'beef semitendinosus muscle fiber characteristics, NADH content, and color stability', 'color stability of semitendinosus (ST) steaks']",[],[],"[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0025852', 'cui_str': 'Ferrimyoglobin'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0069830', 'cui_str': 'Mb-O2 myoglobin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0027289', 'cui_str': 'NADH'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",21.0,0.0330395,Less type IIA fibers were detected at the middle location compared to the other two locations (P < 0.10).,"[{'ForeName': 'Cadra L', 'Initials': 'CL', 'LastName': 'Van Bibber-Krueger', 'Affiliation': 'Department of Animal Sciences and Industry, Kansas State University, Manhattan, KS.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Department of Animal Sciences and Industry, Kansas State University, Manhattan, KS.'}, {'ForeName': 'Kelsey J', 'Initials': 'KJ', 'LastName': 'Phelps', 'Affiliation': 'Cargill Protein, Wichita, KS.'}, {'ForeName': 'Travis G', 'Initials': 'TG', 'LastName': ""O'Quinn"", 'Affiliation': 'Department of Animal Sciences and Industry, Kansas State University, Manhattan, KS.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Houser', 'Affiliation': 'Department of Animal Science, Iowa State University, Ames, IA.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Turner', 'Affiliation': 'Department of Animal and Dairy Science, University of Georgia, Athens, GA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Animal and Dairy Science, University of Georgia, Athens, GA.'}]",Journal of animal science,['10.1093/jas/skaa078']
232,32279841,Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings.,"Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157).",2020,"The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months.","['341 patients with diffuse long lesions (requiring device length ≥28 mm', 'Diffuse Long Coronary Narrowings', 'patients with long native coronary artery disease']","['BVS', 'BVS and metallic everolimus-eluting stent (EES', 'bioresorbable vascular scaffold (BVS) implantation', 'Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents', 'EES']","['BVS and EES', 'death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization', 'mean lesion length', 'Definite or probable device thrombosis', 'major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",341.0,0.119129,"The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months.","[{'ForeName': 'Jongkwon', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Sanggye Paik Hospital, Inje University, Seoul, Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Cardiac Center, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea. Electronic address: dwpark@amc.seoul.kr.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. Electronic address: mkhong61@yuhs.ac.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.02.031']
233,32259228,Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial.,"Importance


Patients with advanced soft tissue sarcoma (STS) have a median overall survival of less than 2 years. In a phase 2 study, an overall survival benefit in this population was observed with the addition of olaratumab to doxorubicin over doxorubicin alone.
Objective


To determine the efficacy of doxorubicin plus olaratumab in patients with advanced/metastatic STS.
Design, Setting, and Participants


ANNOUNCE was a confirmatory, phase 3, double-blind, randomized trial conducted at 110 sites in 25 countries from September 2015 to December 2018; the final date of follow-up was December 5, 2018. Eligible patients were anthracycline-naive adults with unresectable locally advanced or metastatic STS, an Eastern Cooperative Oncology Group performance status of 0 to 1, and cardiac ejection fraction of 50% or greater.
Interventions


Patients were randomized 1:1 to receive doxorubicin, 75 mg/m2 (day 1), combined with olaratumab (n = 258), 20 mg/kg in cycle 1 and 15 mg/kg in subsequent cycles, or placebo (n = 251) on days 1 and 8 for up to 8 21-day cycles, followed by olaratumab/placebo monotherapy.
Main Outcomes and Measures


Dual primary end points were overall survival with doxorubicin plus olaratumab vs doxorubicin plus placebo in total STS and leiomyosarcoma (LMS) populations.
Results


Among the 509 patients randomized (mean age, 56.9 years; 58.2% women; 46.0% with LMS), all were included in the primary analysis and had a median length of follow-up of 31 months. No statistically significant difference in overall survival was observed between the doxorubicin plus olaratumab group vs the doxorubicin plus placebo group in either population (total STS: hazard ratio, 1.05 [95% CI, 0.84-1.30], P = .69, median overall survival, 20.4 months vs 19.7 months; LMS: hazard ratio, 0.95 [95% CI, 0.69-1.31], P = .76, median overall survival, 21.6 months vs 21.9 months). Adverse events of grade 3 or greater reported in 15% or more of total patients with STS were neutropenia (46.3% vs 49.0%), leukopenia (23.3% vs 23.7%), and febrile neutropenia (17.5% vs 16.5%).
Conclusions and Relevance


In this phase 3 clinical trial of patients with advanced STS, treatment with doxorubicin plus olaratumab vs doxorubicin plus placebo resulted in no significant difference in overall survival. The findings did not confirm the overall survival benefit observed in the phase 2 trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT02451943.",2020,"No statistically significant difference in overall survival was observed between the doxorubicin plus olaratumab group vs the doxorubicin plus placebo group in either population (total STS: hazard ratio, 1.05 [95% CI, 0.84-1.30], P = .69, median overall survival, 20.4 months vs 19.7 months; LMS: hazard ratio, 0.95","['Eligible patients were anthracycline-naive adults with unresectable locally advanced or metastatic STS, an Eastern Cooperative Oncology Group performance status of 0 to 1, and cardiac ejection fraction of 50% or greater', 'patients with advanced/metastatic STS', 'Patients with advanced soft tissue sarcoma (STS', '509 patients randomized (mean age, 56.9 years; 58.2% women; 46.0% with LMS), all were included in the primary analysis and had a median length of follow-up of 31 months', 'patients with advanced STS, treatment with', 'Patients With Advanced Soft Tissue Sarcomas', '110 sites in 25 countries from September 2015 to December 2018; the final date of follow-up was December 5, 2018']","['Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo', 'olaratumab/placebo monotherapy', 'doxorubicin plus olaratumab', 'doxorubicin plus olaratumab vs doxorubicin plus placebo', 'doxorubicin', 'doxorubicin plus placebo', 'combined with olaratumab (n\u2009=\u2009258), 20 mg/kg in cycle 1 and 15 mg/kg in subsequent cycles, or placebo']","['overall survival benefit', 'Survival', 'leukopenia', 'febrile neutropenia', 'median overall survival', 'overall survival', 'neutropenia', 'total STS and leiomyosarcoma (LMS) populations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0232174', 'cui_str': 'Cardiac ejection fraction'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023556', 'cui_str': 'Levamisole'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2698152', 'cui_str': 'olaratumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",509.0,0.716157,"No statistically significant difference in overall survival was observed between the doxorubicin plus olaratumab group vs the doxorubicin plus placebo group in either population (total STS: hazard ratio, 1.05 [95% CI, 0.84-1.30], P = .69, median overall survival, 20.4 months vs 19.7 months; LMS: hazard ratio, 0.95","[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wagner', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'University Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martin-Broto', 'Affiliation': 'Medical Oncology Department in University Hospital Virgen del Rocio and Institute of Biomedicine of Sevilla (IBIS) (HUVR, CSIC, University of Sevilla), Sevilla, Spain.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Krarup-Hansen', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Ganjoo', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Chueh-Chuan', 'Initials': 'CC', 'LastName': 'Yen', 'Affiliation': 'Division of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Albiruni R', 'Initials': 'AR', 'LastName': 'Abdul Razak', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Virginia Cancer Specialists, Fairfax.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kawai', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Van Tine', 'Affiliation': 'Department of Internal Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fedenko', 'Affiliation': 'Blokhin Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Pápai', 'Affiliation': 'Magyar Honvedseg Eu Kp, Budapest, Hungary.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Soldatenkova', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Shahir', 'Affiliation': 'Eli Lilly and Company, Windlesham, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Mo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1707']
234,31813636,"Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial.","BACKGROUND


Whole-breast irradiation after breast-conserving surgery for patients with early-stage breast cancer decreases ipsilateral breast-tumour recurrence (IBTR), yielding comparable results to mastectomy. It is unknown whether accelerated partial breast irradiation (APBI) to only the tumour-bearing quadrant, which shortens treatment duration, is equally effective. In our trial, we investigated whether APBI provides equivalent local tumour control after lumpectomy compared with whole-breast irradiation.
METHODS


We did this randomised, phase 3, equivalence trial (NSABP B-39/RTOG 0413) in 154 clinical centres in the USA, Canada, Ireland, and Israel. Adult women (>18 years) with early-stage (0, I, or II; no evidence of distant metastases, but up to three axillary nodes could be positive) breast cancer (tumour size ≤3 cm; including all histologies and multifocal breast cancers), who had had lumpectomy with negative (ie, no detectable cancer cells) surgical margins, were randomly assigned (1:1) using a biased-coin-based minimisation algorithm to receive either whole-breast irradiation (whole-breast irradiation group) or APBI (APBI group). Whole-breast irradiation was delivered in 25 daily fractions of 50 Gy over 5 weeks, with or without a supplemental boost to the tumour bed, and APBI was delivered as 34 Gy of brachytherapy or 38·5 Gy of external bream radiation therapy in 10 fractions, over 5 treatment days within an 8-day period. Randomisation was stratified by disease stage, menopausal status, hormone-receptor status, and intention to receive chemotherapy. Patients, investigators, and statisticians could not be masked to treatment allocation. The primary outcome of invasive and non-invasive IBTR as a first recurrence was analysed in the intention-to-treat population, excluding those patients who were lost to follow-up, with an equivalency test on the basis of a 50% margin increase in the hazard ratio (90% CI for the observed HR between 0·667 and 1·5 for equivalence) and a Cox proportional hazard model. Survival was assessed by intention to treat, and sensitivity analyses were done in the per-protocol population. This trial is registered with ClinicalTrials.gov, NCT00103181.
FINDINGS


Between March 21, 2005, and April 16, 2013, 4216 women were enrolled. 2109 were assigned to the whole-breast irradiation group and 2107 were assigned to the APBI group. 70 patients from the whole-breast irradiation group and 14 from the APBI group withdrew consent or were lost to follow-up at this stage, so 2039 and 2093 patients respectively were available for survival analysis. Further, three and four patients respectively were lost to clinical follow-up (ie, survival status was assessed by phone but no physical examination was done), leaving 2036 patients in the whole-breast irradiation group and 2089 in the APBI group evaluable for the primary outcome. At a median follow-up of 10·2 years (IQR 7·5-11·5), 90 (4%) of 2089 women eligible for the primary outcome in the APBI group and 71 (3%) of 2036 women in the whole-breast irradiation group had an IBTR (HR 1·22, 90% CI 0·94-1·58). The 10-year cumulative incidence of IBTR was 4·6% (95% CI 3·7-5·7) in the APBI group versus 3·9% (3·1-5·0) in the whole-breast irradiation group. 44 (2%) of 2039 patients in the whole-breast irradiation group and 49 (2%) of 2093 patients in the APBI group died from recurring breast cancer. There were no treatment-related deaths. Second cancers and treatment-related toxicities were similar between the two groups. 2020 patients in the whole-breast irradiation group and 2089 in APBI group had available data on adverse events. The highest toxicity grade reported was: grade 1 in 845 (40%), grade 2 in 921 (44%), and grade 3 in 201 (10%) patients in the APBI group, compared with grade 1 in 626 (31%), grade 2 in 1193 (59%), and grade 3 in 143 (7%) in the whole-breast irradiation group.
INTERPRETATION


APBI did not meet the criteria for equivalence to whole-breast irradiation in controlling IBTR for breast-conserving therapy. Our trial had broad eligibility criteria, leading to a large, heterogeneous pool of patients and sufficient power to detect treatment equivalence, but was not designed to test equivalence in patient subgroups or outcomes from different APBI techniques. For patients with early-stage breast cancer, our findings support whole-breast irradiation following lumpectomy; however, with an absolute difference of less than 1% in the 10-year cumulative incidence of IBTR, APBI might be an acceptable alternative for some women.
FUNDING


National Cancer Institute, US Department of Health and Human Services.",2019,"INTERPRETATION


APBI did not meet the criteria for equivalence to whole-breast irradiation in controlling IBTR for breast-conserving therapy.","['70 patients from the whole-breast irradiation group and 14 from the APBI group withdrew consent or were lost to follow-up at this stage, so 2039 and 2093 patients respectively were available for survival analysis', 'patients with early-stage breast cancer decreases ipsilateral breast-tumour recurrence (IBTR', 'Between March 21, 2005, and April 16, 2013, 4216 women were enrolled', 'early-stage breast cancer', '2020 patients in the whole-breast irradiation group and 2089 in APBI group had available data on', 'patients with early-stage breast cancer', '154 clinical centres in the USA, Canada, Ireland, and Israel', 'Adult women (>18 years) with early-stage (0, I, or II; no evidence of distant metastases, but up to three axillary nodes could be positive) breast cancer (tumour size ≤3 cm; including all histologies and multifocal breast cancers), who had had lumpectomy with negative (ie, no detectable cancer cells) surgical margins']","['brachytherapy or 38·5 Gy of external bream radiation therapy', 'biased-coin-based minimisation algorithm to receive either whole-breast irradiation (whole-breast irradiation group) or APBI (APBI group', 'APBI', 'Whole-breast irradiation after breast-conserving surgery', 'accelerated partial breast irradiation after breast-conserving surgery']","['hazard ratio', 'invasive and non-invasive IBTR as a first recurrence', 'adverse events', 'Survival', 'toxicities', '10-year cumulative incidence of IBTR', 'highest toxicity grade', 'survival status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1458155', 'cui_str': 'Breast Tumors'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0229985', 'cui_str': 'Margins of Excision'}]","[{'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0452965', 'cui_str': 'Bream (substance)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0524669', 'cui_str': 'Coins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",2039.0,0.272324,"INTERPRETATION


APBI did not meet the criteria for equivalence to whole-breast irradiation in controlling IBTR for breast-conserving therapy.","[{'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Vicini', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; MHP Radiation Oncology Institute, St Joseph Mercy Hospital Campus, Pontiac, MI, USA. Electronic address: frank.vicini@21co.com.'}, {'ForeName': 'Reena S', 'Initials': 'RS', 'LastName': 'Cecchini', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Julia R', 'Initials': 'JR', 'LastName': 'White', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Ohio State University Comprehensive Cancer Center-Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH, USA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Arthur', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Julian', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Allegheny Health Network Cancer Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Rabinovitch', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Kuske', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Arizona Breast Cancer Specialists, Arizona Center for Cancer Care, Scottsdale, AZ, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Ganz', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Parda', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Allegheny Health Network Cancer Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Scheier', 'Affiliation': 'Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Winter', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, PA, USA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Kuerer', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Vallow', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'Southwest Oncology Group Cancer Research Network, Hope Foundation for Cancer Research, Portland, OR, USA; Rogel Cancer Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Orlando Health, UF Health Cancer Center, Orlando, FL, USA.'}, {'ForeName': 'Beryl', 'Initials': 'B', 'LastName': 'McCormick', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Costantino', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Harry D', 'Initials': 'HD', 'LastName': 'Bear', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Germain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Centre Hospitalier Universitaire de Québec-Université Laval, Pavillon Hôtel-Dieu de Québec, Québec City, QC, Canada.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gustafson', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Community Clinical Oncology Program, William Beaumont Hospital, Sterling Heights, MI, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Grossheim', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Summit Cancer Center, Post Falls, ID, USA.'}, {'ForeName': 'Ivy A', 'Initials': 'IA', 'LastName': 'Petersen', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Hudes', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Saint Agnes Hospital, Baltimore, MD, USA; Thomas Jefferson University, Baltimore, MD, USA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Curran', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Bryant', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, PA, USA; University of Pittsburgh, Pittsburgh, PA, USA; Allegheny Health Network Cancer Institute, Pittsburgh, PA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)32514-0']
235,31113987,"Efficacy and safety of esaxerenone (CS-3150) for the treatment of essential hypertension: a phase 2 randomized, placebo-controlled, double-blind study.","This was a phase 2, multicenter, randomized, double-blind, placebo-controlled, open-label comparator study to investigate the efficacy and safety of esaxerenone (CS-3150), a novel non-steroidal mineralocorticoid receptor blocker, in Japanese patients with essential hypertension. Eligible patients (n = 426) received esaxerenone (1.25, 2.5, or 5 mg/day), placebo, or eplerenone (50-100 mg/day) for 12 weeks. The primary efficacy endpoint was the change from baseline in sitting systolic and diastolic blood pressure (BP). Safety endpoints included adverse events and serum K +  elevation. There were significant dose-response reductions in the 2.5 and 5 mg/day esaxerenone groups for sitting BP (both p < 0.001) and 24-h BP (both p < 0.0001) compared with placebo, with a mean (95% confidence interval) change in sitting BP of -7.0 (-9.5 to -4.6)/-3.8 (-5.2 to -2.4) mmHg in the placebo group, and -10.7 (-13.2 to -8.2)/-5.0 (-6.4 to -3.6) mmHg, -14.3 (-16.8 to -11.9)/-7.6 (-9.1 to -6.2) mmHg, and -20.6 (-23.0 to -18.2)/ -10.4 (-11.8 to -9.0) mmHg for the 1.25, 2.5, and 5 mg/day esaxerenone groups, respectively, while the change was -17.4 (-19.9 to -15.0)/-8.5 (-9.9 to -7.1) mmHg for eplerenone. The incidence of adverse events was similar in all treatment groups. Serum K +  levels initially increased in proportion with esaxerenone dose but were stable from week 2 until week 12. Plasma esaxerenone concentration increased in proportion with the dose. In conclusion, esaxerenone is an effective and tolerable treatment option for patients with essential hypertension.",2019,Serum K +  levels initially increased in proportion with esaxerenone dose but were stable from week 2 until week 12.,"['essential hypertension', 'Japanese patients with essential hypertension', 'Eligible patients (n\u2009=\u2009426) received', 'patients with essential hypertension']","['placebo, or eplerenone', 'esaxerenone', 'esaxerenone (CS-3150', 'placebo']","['dose-response reductions', 'Plasma esaxerenone concentration', '24-h BP', 'Serum K +  levels', 'adverse events', 'sitting BP', 'Efficacy and safety', 'sitting systolic and diastolic blood pressure (BP', 'adverse events and serum K +  elevation']","[{'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C4278755', 'cui_str': 'CS-3150'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.342126,Serum K +  levels initially increased in proportion with esaxerenone dose but were stable from week 2 until week 12.,"[{'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan. db554@med.tohoku.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamakawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Journal of human hypertension,['10.1038/s41371-019-0207-x']
236,30671591,"Effects of High-Intensity Interval Running Versus Cycling on Sclerostin, and Markers of Bone Turnover and Oxidative Stress in Young Men.","This study compared sclerostin's response to impact versus no-impact high-intensity interval exercise in young men and examined the association between exercise-induced changes in sclerostin and markers of bone turnover and oxidative stress. Twenty healthy men (22.3 ± 2.3 years) performed two high-intensity interval exercise trials (crossover design); running on treadmill and cycling on cycle ergometer. Trials consisted of eight 1 min running or cycling intervals at ≥ 90% of maximal heart rate, separated by 1 min passive recovery intervals. Blood samples were collected at rest (pre-exercise), and 5 min, 1 h, 24 h, and 48 h following each trial. Serum levels of sclerostin, cross-linked telopeptide of type I collagen (CTXI), procollagen type I amino-terminal propeptide (PINP), thiobarbituric acid reactive substances (TBARS), and protein carbonyls (PC) were measured. There was no significant time or exercise mode effect for PINP and PC. A significant time effect was found for sclerostin, CTXI, and TBARS with no significant exercise mode effect and no significant time-by-mode interaction. Sclerostin increased from pre- to 5 min post-exercise (47%, p < 0.05) and returned to baseline within 1 h following the exercise. CTXI increased from pre- to 5 min post-exercise (28%, p < 0.05), then gradually returned to baseline by 48 h. TBARS did not increase significantly from pre- to 5 min post-exercise but significantly decreased from 5 min to 48 h post-exercise. There were no significant correlations between exercise-induced changes in sclerostin and any other marker. In young men, sclerostin's response to high-intensity interval exercise is independent of impact and is not related to changes in bone turnover and oxidative stress markers.",2019,"Sclerostin increased from pre- to 5 min post-exercise (47%, p < 0.05) and returned to baseline within 1 h following the exercise.","['Young Men', 'Twenty healthy men (22.3\u2009±\u20092.3\xa0years) performed two', 'young men']","['I collagen (CTXI), procollagen type', 'high-intensity interval exercise trials (crossover design); running on treadmill and cycling on cycle ergometer', 'High-Intensity Interval Running Versus Cycling']","['I amino-terminal propeptide (PINP), thiobarbituric acid reactive substances (TBARS), and protein carbonyls (PC', 'Blood samples', 'Sclerostin', 'Serum levels of sclerostin, cross-linked telopeptide of type', 'sclerostin, CTXI, and TBARS', 'CTXI', 'bone turnover and oxidative stress', 'Sclerostin, and Markers of Bone Turnover and Oxidative Stress']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",20.0,0.0553336,"Sclerostin increased from pre- to 5 min post-exercise (47%, p < 0.05) and returned to baseline within 1 h following the exercise.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kouvelioti', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Health Science, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Falk', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Ward', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Klentrou', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada. nklentrou@brocku.ca.'}]",Calcified tissue international,['10.1007/s00223-019-00524-1']
237,32259005,Platelet-rich plasma in the management of Asherman's syndrome: An RCT.,"Background


Asherman's syndrome (AS) is a rare reproductive abnormality, resulting in endometrial collapse due to aggressive or recurrent endometritis and/or curettage.
Objective


We aimed to assess the effectiveness of using platelet-rich plasma (PRP) to lower the recurrence rate of intrauterine adhesions (IUAs) following hysteroscopy.
Materials and Methods


In this non-randomized clinical trial, women aged 20-45 years with AS diagnosed by sonohysterography, 3D sonography, hysteroscopy, or uterosalpingography between May 2018 and September 2018 were included. Participants (n = 30) were divided into case and control groups. Following hysteroscopic adhesiolysis, a Foley catheter was placed into the uterine cavity in all women. After two days, the catheter was removed, and 1-mL PRP was injected into the uterine cavity of women in the PRP (case) group, while the control received no PRP. All controls and subjects underwent diagnostic hysteroscopy 8-10 weeks following the intervention to assess the IUAs according to the American Society for Reproductive Medicine scoring system.
Results


Our results did not reveal any significant difference in the menstrual pattern of either the control or test groups before or after treatment (p = 0.2). Moreover, the IUA stage in both studied groups before and after treatment was similar (p = 0.2). The duration of menstrual bleeding in both studied groups before and after treatment was also similar.
Conclusion


PRP cannot change the menstrual pattern or development of postsurgical AS, as evaluated by follow-up hysteroscopy.",2020,Our results did not reveal any significant difference in the menstrual pattern of either the control or test groups before or after treatment (p = 0.2).,"[""Asherman's syndrome"", 'Participants (n = 30', 'women aged 20-45 years with AS diagnosed by sonohysterography, 3D sonography, hysteroscopy, or uterosalpingography between May 2018 and September 2018 were included']","['diagnostic hysteroscopy', 'control received no PRP', 'platelet-rich plasma (PRP', 'Platelet-rich plasma']",['duration of menstrual bleeding'],"[{'cui': 'C0156372', 'cui_str': 'Asherman syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}]",30.0,0.0626376,Our results did not reveal any significant difference in the menstrual pattern of either the control or test groups before or after treatment (p = 0.2).,"[{'ForeName': 'Atiyeh', 'Initials': 'A', 'LastName': 'Javaheri', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Katayoon', 'Initials': 'K', 'LastName': 'Kianfar', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Pourmasumi', 'Affiliation': 'Non-Communicable Diseases Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eftekhar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i2.6423']
238,30627973,Phytomedicines in the Treatment of Migraine.,"Migraine is a disabling neurovascular disorder with few targeted, tolerable and effective treatments. Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine. Many patients also turn toward herbal and plant-based therapies for the treatment of their migraines as clinical and preclinical evidence of efficacy increases. Patients seek effective and tolerable treatments instead of or in addition to current conventional pharmacologic therapies. We review some phytomedicines potentially useful for migraine treatment-feverfew (Tanacetum parthenium), butterbur (Petasites hybridus), marijuana (Cannabis spp.), Saint John's Wort (Hypericum perforatum) and the Damask rose (Rosa × damascena)-with respect to their mechanisms of action and evidence for treatment of migraine. The evidence for feverfew is mixed; butterbur is effective with potential risks of hepatotoxicity related to preparation; marijuana has not been shown to be effective in migraine treatment, and data are scant; Saint John's Wort shows relevant physiological activity but is a hepatic enzyme inducer and lacks clinical studies for this purpose; the Damask rose when used in topical preparations did not show efficacy in one clinical trial. Other plant preparations have been considered for migraine treatment but most without blinded randomized, placebo-controlled trial evidence.",2019,"Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine.",[],"['Migraine', 'placebo']",[],[],"[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.067028,"Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine.","[{'ForeName': 'Thilinie', 'Initials': 'T', 'LastName': 'Rajapakse', 'Affiliation': 'Division of Neurology, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada. Thilinie.Rajapakse@albertahealthservices.ca.'}, {'ForeName': 'William Jeptha', 'Initials': 'WJ', 'LastName': 'Davenport', 'Affiliation': 'Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}]",CNS drugs,['10.1007/s40263-018-0597-2']
239,32223002,Articaine efficacy and safety in young children below the age of four years: An equivalent parallel randomized control trial.,"BACKGROUND


Pain control is a mandatory aspect in pediatric dentistry office through local anesthesia.
AIM


To assess the safety and efficacy of 4% articaine local anesthetic in young children below four years old.
DESIGN


An equivalent randomized control trial with two parallel arms included 184 young children (92 per group) aged from 36 to 47 months seeking pulpotomy of mandibular primary molars which performed after buccal infiltration injection. The control group received lidocaine hydrochloride 2% with epinephrine 1:100 000. The intervention was articaine hydrochloride 4% with epinephrine 1:100 000. Children's behavior during injection and treatment have assessed using Faces, Legs, Activity, Cry, and Consolability (FLACC) and child's behavior using Frankl Behavior Rating Scale (FBRS). In addition, post-operative complications have been addressed.
RESULTS


Both anesthetic agents were equivalent during the injection phase. During the treatment phase, the absolute risk difference (ARR) between the two groups was 0.120 (95% CI: -0.003; 0.243). The maximum limit of 95% CI surpassed the margin of equivalence, indicating that less pain has been expressed during pulpotomy among children delivered articaine when compared to their counterparts in the lidocaine group. Concerning post-operative complications, no statistically significant difference was detected between the two anesthetic drugs.
CONCLUSION


The findings supported the efficient and secure use of articaine hydrochloride 4% with epinephrine 1:100 000 to treat children between the ages of 3 and below 4 years old.",2020,"Concerning postoperative complications, no statistically significant has been demonstrated between the two anesthetic drugs.
","['184 young children (92 per group) aged from 36 to 47 months seeking pulpotomy of mandibular primary molars which performed after buccal infiltration injection', 'Young Children below Age of Four Years', 'young children below four-years-old']","['articaine hydrochloride', 'lidocaine hydrochloride', 'articaine local anesthetic', 'epinephrine 1:100000', 'articaine', 'epinephrine', 'lidocaine']","[""Faces, Legs, Activity, Cry and Consolability (FLACC) and child's behavior using Frankl Behaviour Rating Scale (FBRS"", 'absolute risk difference (ARR', 'safety and efficacy', 'Articaine Efficacy and Safety']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0007300', 'cui_str': 'Articaine hydrochloride'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine Hydrochloride'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0475483', 'cui_str': 'Behavioral Rating Scale'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}]",184.0,0.0888032,"Concerning postoperative complications, no statistically significant has been demonstrated between the two anesthetic drugs.
","[{'ForeName': 'Ahmad Abdel Hamid', 'Initials': 'AAH', 'LastName': 'Elheeny', 'Affiliation': 'Faculty of Dentistry, Minia University, El Minia, Egypt.'}]",International journal of paediatric dentistry,['10.1111/ipd.12640']
240,32259004,Comparison of letrozole with gonadotropin-releasing hormone agonist in frozen embryo transfer after recurrent implantation failure: An RCT.,"Background


The use of frozen embryo transfer (FET) is increasing worldwide in the treatment of infertility by in vitro fertilization. Different methods of endometrial preparation for FET have been suggested.
Objective


The aim of this study was to compare the pregnancy outcomes after treatment with letrozole and those after treatment with the combination of gonadotropin-releasing hormone (GnRH) agonist and estradiol in FET.
Materials and Methods


This randomized controlled trial study was conducted on 142 infertile women with a history of previous FET failure. Participants were randomly assigned to two groups (n = 71 each). The GnRH group received 500 µg of buserelin plus 4mg estradiol (which increased to 8 mg if endometrial thickness was less than 5 mm), and the letrozole group received 5 mg of letrozole plus 75 IU of recombinant human follicle-stimulating hormone). At least two high-quality embryos were transferred to each subject in both groups. The outcome measures were clinical pregnancy rate and fetal heart rate detection.
Results


Subjects in the study groups had similar demographic characteristics and baseline clinical condition. Mean endometrial thickness in the letrozole and GnRH agonist groups were 8.90  ±  0.88 mm and 8.99  ±  0.85 mm, respectively (p = 0.57). The number of positive results of the beta human chorionic gonadotropin test and detection of fetal heartbeat were not significantly different between the groups (p  >  0.05).
Conclusion


The administration of letrozole and GnRH may produce similar pregnancy outcomes in FET.",2020,"The number of positive results of the beta human chorionic gonadotropin test and detection of fetal heartbeat were not significantly different between the groups (p  >  0.05).
","['frozen embryo transfer after recurrent implantation failure', '142 infertile women with a history of previous FET failure']","['frozen embryo transfer (FET', 'letrozole and GnRH', 'gonadotropin-releasing hormone (GnRH) agonist and estradiol', 'letrozole with gonadotropin-releasing hormone agonist', 'buserelin plus 4mg estradiol', 'letrozole plus 75 IU of recombinant human follicle-stimulating hormone', 'letrozole']","['pregnancy outcomes', 'number of positive results of the beta human chorionic gonadotropin test and detection of fetal heartbeat', 'clinical pregnancy rate and fetal heart rate detection', 'Mean endometrial thickness']","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0006456', 'cui_str': 'Buserelin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016774', 'cui_str': 'Human follicle stimulating hormone'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0106132', 'cui_str': 'Human chorionic gonadotropin, beta subunit'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",142.0,0.112702,"The number of positive results of the beta human chorionic gonadotropin test and detection of fetal heartbeat were not significantly different between the groups (p  >  0.05).
","[{'ForeName': 'Nayere', 'Initials': 'N', 'LastName': 'Khadem Ghaebi', 'Affiliation': 'Department of Obstetrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Mahmoudiniya', 'Affiliation': 'Department of Obstetrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Najaf Najafi', 'Affiliation': 'Imam Reza Clinical Research Units, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Zohdi', 'Affiliation': 'Department of Obstetrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Matin', 'Initials': 'M', 'LastName': 'Attaran', 'Affiliation': 'Department of Obstetrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i2.6417']
241,30835626,"Predicting early emotion knowledge development among children of colour living in historically disinvested neighbourhoods: consideration of child pre-academic abilities, self-regulation, peer relations and parental education.","Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems. Less is known, however, about predictors of early development of emotion knowledge. This study examines emotion knowledge development among children attending pre-Kindergarten and Kindergarten programmes in high-poverty urban schools. The study considers child pre-academic abilities, self-regulation, peer relations and parental education as predictors of emotion knowledge development over two years. The sample ( n  = 1034) of children living in historically disinvested neighbourhoods was primarily Black (85%) and low-income (∼61%). The sample was part of a longitudinal follow-up study of a cluster (school) randomised controlled trial in ten public elementary schools. Children's emotion knowledge was assessed with a series of tasks three times over a two-year period. At baseline, parents and teachers reported on peer relations, children completed a test of pre-academic abilities, independent observers rated child self-regulation, and parents reported on their educational attainment. Results demonstrate that emotion knowledge increases over time, and pre-academic abilities, self-regulation, peer relations, and parent education independently predict children's emotion knowledge. This study highlights multiple factors that predict emotion knowledge among primarily Black children living in historically disinvested neighbourhoods.",2019,"Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems.","['children attending pre-Kindergarten and Kindergarten programmes in high-poverty urban schools', 'The sample (n\u2009=\u20091034) of children living in historically disinvested neighbourhoods was primarily Black (85%) and low-income (∼61', 'primarily Black children living in historically disinvested neighbourhoods', 'children of colour living in historically disinvested neighbourhoods', 'ten public elementary schools']",[],"['emotion knowledge development', 'Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems', ""emotion knowledge increases over time, and pre-academic abilities, self-regulation, peer relations, and parent education independently predict children's emotion knowledge"", ""Children's emotion knowledge""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0683256', 'cui_str': 'Social Competence'}, {'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0242261', 'cui_str': 'Parenting Education'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",10.0,0.0157764,"Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ursache', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}, {'ForeName': 'Spring', 'Initials': 'S', 'LastName': 'Dawson-McClure', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Siegel', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}, {'ForeName': 'Laurie Miller', 'Initials': 'LM', 'LastName': 'Brotman', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}]",Cognition & emotion,['10.1080/02699931.2019.1587388']
242,30585803,Sex-specific and Age-specific Analgesia for Early Postoperative Pain Management After Lumbar Decompressive Surgery: A Randomized Clinical Trial.,"STUDY DESIGN


This was a randomized clinical trial.
OBJECTIVE


To compare the efficacy and safety of nonsteroidal anti-inflammatory drug and opioid for acute pain management after lumbar decompressive surgery.
SUMMARY OF BACKGROUND DATA


Multimodal analgesia is associated with synergistic effects while reducing opioid-related adverse effects. However, there is no consensus on the ideal multimodal analgesic regimen. We assumed that each agent in various multimodal regimens under different conditions may have different effects.
MATERIALS AND METHODS


This prospective randomized clinical trial recruited adult patients who underwent single-level lumbar decompressive surgery. Patients were randomized to receive our postoperative analgesic regimen including either nonsteroidal anti-inflammatory drug (celecoxib) or opioid (extended-release oxycodone) from postoperative day 3 to 14. The Visual Analog Scale (VAS) and Oswestry Back Pain Disability Index (ODI) were used to evaluate effectiveness preoperatively and on postoperative days 2, 3, 7, and 14, and at 6 months. Drug-related adverse effects were also recorded.
RESULTS


One hundred patients were enrolled and 93 patients (46 patients with celecoxib vs. 47 patients with oxycodone) were randomized. No differences were observed in patient demographics and preoperative VAS and ODI between the 2 groups. VAS and ODI were not different at all postoperative time points. However, subanalysis according to sex and age, revealed significant differences in efficacy: celecoxib was effective in female individuals and oxycodone was effective in male individuals on postoperative days 7 and 14; oxycodone was effective in patients aged above 65 years on postoperative days 7 and 14. Although nausea/vomiting and constipation were more common in the oxycodone group than in the celecoxib group, other adverse effects were not different.
CONCLUSIONS


In patients who underwent single-level lumbar decompressive surgery, treatment with celecoxib and oxycodone for postoperative pain management showed no significant differences in efficacy. However, subanalysis showed that each drug was effective in different ages and sex groups.
LEVEL OF EVIDENCE


Level II.",2019,No differences were observed in patient demographics and preoperative VAS and ODI between the 2 groups.,"['After Lumbar Decompressive Surgery', 'acute pain management after lumbar decompressive surgery', 'female individuals and', 'patients aged above 65 years on postoperative days 7 and 14', 'One hundred patients were enrolled and 93 patients (46 patients with celecoxib vs. 47 patients with', 'adult patients who underwent single-level lumbar decompressive surgery']","['oxycodone', 'nonsteroidal anti-inflammatory drug and opioid', 'postoperative analgesic regimen including either nonsteroidal anti-inflammatory drug (celecoxib) or opioid (extended-release oxycodone', 'celecoxib', 'celecoxib and oxycodone']","['patient demographics and preoperative VAS and ODI', 'VAS and ODI', 'adverse effects', 'efficacy', 'nausea/vomiting and constipation', 'efficacy and safety', 'Visual Analog Scale (VAS) and Oswestry', 'Back Pain Disability Index (ODI']","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",100.0,0.132711,No differences were observed in patient demographics and preoperative VAS and ODI between the 2 groups.,"[{'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kee-Yong', 'Initials': 'KY', 'LastName': 'Ha', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'An', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Kee-Won', 'Initials': 'KW', 'LastName': 'Rhyu', 'Affiliation': 'Department of Orthopaedic Surgery, St. Vincent Hospital, College of Medicine.'}, {'ForeName': 'Hyun-Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': ""Department of Orthopaedic Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'In-Soo', 'Initials': 'IS', 'LastName': 'Oh', 'Affiliation': ""Department of Orthopaedic Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",Clinical spine surgery,['10.1097/BSD.0000000000000761']
243,32198939,"Safety, pharmacokinetics and pharmacodynamics of branebrutinib (BMS-986195), a covalent, irreversible inhibitor of Bruton's tyrosine kinase: Randomised phase I, placebo-controlled trial in healthy participants.","AIMS


Branebrutinib (BMS-986195) is a potent, highly selective, oral, small-molecule, covalent inhibitor of Bruton's tyrosine kinase (BTK). This study evaluated safety, pharmacokinetics and pharmacodynamics of branebrutinib in healthy participants.
METHODS


This double-blind, placebo-controlled, single- and multiple-ascending dose (SAD; MAD) Phase I study (NCT02705989) enrolled participants into 3 parts: SAD, MAD and JMAD (MAD in first-generation Japanese participants). In each part, participants were randomised 3:1 to receive branebrutinib (SAD: 0.3-30 mg; [J]MAD: 0.3-10 mg) or placebo. Participants in the MAD parts received branebrutinib daily for 14 days and were followed for 14 days postdosing. Safety was assessed by monitoring, laboratory and physical examinations, vital signs, and recording adverse events (AEs). Pharmacodynamics were assessed with a mass spectrometry assay that measured drug-occupied and free BTK.
RESULTS


The SAD, MAD and JMAD parts of the study included 40, 32 and 24 participants. Branebrutinib was well tolerated and AEs were mild/moderate, except for 1 serious AE that led to discontinuation. Branebrutinib was rapidly absorbed, with maximum plasma concentration occurring within 1 hour and a half-life of 1.2-1.7 hours, dropping to undetectable levels within 24 hours. BTK occupancy was rapid, with 100% occupancy reached after a single 10-mg dose. BTK occupancy decayed predictably over time (mean half-life in MAD panels: 115-154 hours), such that pharmacodynamic effects were maintained after branebrutinib plasma levels fell below the lower limit of quantification.
CONCLUSION


Rapid and high occupancy of BTK and the lack of notable safety findings support further clinical development of branebrutinib.",2020,"BTK occupancy decayed predictably over time (mean half-life in MAD panels:115-154 hours), such that pharmacodynamic effects were maintained after branebrutinib plasma levels fell below the lower limit of quantification.
","['Healthy Participants', 'healthy participants', ""Bruton's Tyrosine Kinase"", 'enrolled participants into 3 parts: SAD, MAD and JMAD (MAD in first-generation Japanese participants']","['branebrutinib (SAD: 0.3-30 mg; [J]MAD: 0.3-10 mg) or placebo', 'placebo-controlled, single- and multiple-ascending dose (SAD', 'Placebo', 'Branebrutinib (BMS-986195']","['monitoring, laboratory and physical examinations, vital signs and recording adverse events (AEs', 'Safety, Pharmacokinetics and Pharmacodynamics', 'tolerated and AEs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0518766'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.355266,"BTK occupancy decayed predictably over time (mean half-life in MAD panels:115-154 hours), such that pharmacodynamic effects were maintained after branebrutinib plasma levels fell below the lower limit of quantification.
","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Catlett', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Miroslawa', 'Initials': 'M', 'LastName': 'Nowak', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Kundu', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Naiyu', 'Initials': 'N', 'LastName': 'Zheng', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ihab G', 'Initials': 'IG', 'LastName': 'Girgis', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Grasela', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14290']
244,31176108,Neural mechanisms of expectancy-based placebo effects in antidepressant clinical trials.,"BACKGROUND


Patient expectancy of therapeutic improvement is a primary mediator of placebo effects in antidepressant clinical trials, but its mechanisms are poorly understood. This study employed a novel antidepressant trial design, with integrated functional magnetic resonance imaging (fMRI), to manipulate patient outcome expectancy and examine its neural mediators.
METHOD


Twenty-three depressed outpatients, in a randomized controlled trial were assigned to either Open (high outcome expectancy) or Placebo-controlled (low outcome expectancy) treatment with citalopram for eight weeks. fMRI scans were acquired before and after the expectancy manipulation (before medication treatment), while participants performed a masked emotional face task. Focusing on an amygdala region-of-interest (ROI), we tested a model where reduction in amygdala activation mediated outcome expectancy effects on the slope of change in depressive symptoms.
RESULTS


Following the manipulation, significant differences between conditions were found in neural activation changes in the amygdala, as well as in superior temporal gyrus, insula, and thalamus. Findings support the proposed mediation model according to which activation in the left amygdala ROI decreased significantly in the Open as opposed to the Placebo-controlled group following randomization (p = 0.009) for sad vs. neutral face contrast. The reduced left amygdala activation, in turn, was a significant predictor of decreased depressive symptoms during the trial (p = 0.007), and the mediation model was significant.
CONCLUSIONS


Results from this study, the first designed to identify the neural mechanisms of expectancy augmentation in an antidepressant randomized control trial, suggest that therapeutic modulation of amygdala activity may be an important pathway by which patient outcome expectancy influences depressive symptoms. CLINICALTRIALS.
GOV IDENTIFIER


NCT01919216; Trial name: Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms, URL: https://clinicaltrials.gov/ct2/show/NCT01919216.",2019,"Following the manipulation, significant differences between conditions were found in neural activation changes in the amygdala, as well as in superior temporal gyrus, insula, and thalamus.",['Twenty-three depressed outpatients'],"['Placebo-controlled (low outcome expectancy) treatment with citalopram', 'Placebo', 'integrated functional magnetic resonance imaging (fMRI']","['Depression: Cognitive and Neural Mechanisms, URL', 'left amygdala ROI', 'depressive symptoms', 'reduced left amygdala activation', 'neural activation changes']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C3541384', 'cui_str': 'Uniform resource locator (foundation metadata concept)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",23.0,0.175361,"Following the manipulation, significant differences between conditions were found in neural activation changes in the amygdala, as well as in superior temporal gyrus, insula, and thalamus.","[{'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'Department of Psychology, University of Haifa Mount Carmel, Haifa, 31905, Israel. Electronic address: sigalzil@psy.haifa.ac.il.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: Zhishun.Wang@nyspi.columbia.edu.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Peterson', 'Affiliation': '(c)Keck School of Medicine University of Southern California, USA. Electronic address: bpeterson@chla.usc.edu.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: Melanie.Wall@nyspi.columbia.edu.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: chenying8787@163.com.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Department of Psychology and Neuroscience and the Institute of Cognitive Science University of Colorado at Boulder, USA. Electronic address: Tor.Wager@Colorado.EDU.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Brown', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: pb2410@cumc.columbia.edu.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Roose', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: spr2@cumc.columbia.edu.'}, {'ForeName': 'Bret R', 'Initials': 'BR', 'LastName': 'Rutherford', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: brr8@columbia.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.05.023']
245,31093952,"Safety, Pharmacokinetics and Pharmacodynamics of TNHH, a Novel Targeted Neutrophil-Inhibitory Hirulog Hybrid Glycoprotein, in Healthy Volunteers.","BACKGROUND


Targeted neutrophil inhibitory-hirulog (TNHH) is a novel hybrid glycoprotein that may be a potential drug candidate for acute ischaemic stroke.
OBJECTIVE


The aim of this study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TNHH in healthy volunteers and thereby determine the dose range for future clinical studies.
METHODS


This randomized, placebo-controlled study was a single ascending dose design with dose levels of 0.05-1.8 mg/kg (n = 4-6 active, 2 placebos per cohort) in 68 participants. In the TNHH 0.2-1.8 mg/kg and control cohorts, pharmacokinetic and pharmacodynamic blood samples were collected over 168 h after intravenous (IV) administration. TNHH occupancy in peripheral blood neutrophils and blood coagulation were evaluated as the markers of target engagement.
RESULTS


Two subjects withdrew from the trial before administration of the study treatment, 66 subjects are included in the data analysis. TNHH was well tolerated in all dose regimens. In total, five mild, self-limiting adverse events (AEs) were observed in 4 of the 66 study subjects. Dose-proportional increases in maximum plasma concentration (C max ) and area under the curve (AUC 0-t ) of TNHH were observed. Traces of TNHH were excreted in urine. The elimination half-life (t ½ ) ranged from 0.6 to 1.3 h in the eight groups with ascending dose levels. TNHH combined with CD11b/CD18 quickly achieved > 90% receptor occupancy in groups with doses above 0.2 mg/kg. The C max  and AUC of binding TNHH with CD11b/CD18 increased with the dose. A significant prolongation with dose was observed on thrombin time (TT), and weak influences were observed on prothrombin time (PT) and activated partial thromboplastin time (APTT).
CONCLUSION


TNHH was well-tolerated following IV infusion. The pharmacokinetic and pharmacodynamic characteristics of TNHH indicate that it merits clinical trials. It is recommended that the single dose of TNHH should be 1.0 mg/kg in future studies, and the expected effect may be achieved after 5-7 days of continuous administration.
TRIAL REGISTRATION


The study is registered at http://www.chictr.org.cn as ChiCTR-TQR-14004752.",2019,TNHH combined with CD11b/CD18 quickly achieved > 90% receptor occupancy in groups with doses above 0.2 mg/kg.,"['Healthy Volunteers', 'healthy volunteers', '68 participants', 'Two subjects withdrew from the trial before administration of the study treatment, 66 subjects are included in the data analysis']","['neutrophil inhibitory-hirulog (TNHH', 'TNHH', 'TNHH combined with CD11b/CD18', 'placebo']","['pharmacokinetic and pharmacodynamic blood samples', 'maximum plasma concentration (C max ) and area under the curve (AUC 0-t ) of TNHH', 'thrombin time (TT', 'C max  and AUC of binding TNHH with CD11b/CD18', 'safety, tolerability, pharmacokinetics and pharmacodynamics', 'prothrombin time (PT) and activated partial thromboplastin time (APTT', 'TNHH occupancy in peripheral blood neutrophils and blood coagulation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0210057', 'cui_str': 'Hirulog'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0079785', 'cui_str': 'Integrin alphaMbeta2'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0079785', 'cui_str': 'Integrin alphaMbeta2'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0005778', 'cui_str': 'Blood Clotting'}]",,0.0807768,TNHH combined with CD11b/CD18 quickly achieved > 90% receptor occupancy in groups with doses above 0.2 mg/kg.,"[{'ForeName': 'Zhong Ping', 'Initials': 'ZP', 'LastName': 'Gou', 'Affiliation': 'GCP Center, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Zi Hui', 'Initials': 'ZH', 'LastName': 'Song', 'Affiliation': 'Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co. Ltd, Tianjin, 300301, China.'}, {'ForeName': 'Xiao Gang', 'Initials': 'XG', 'LastName': 'Chen', 'Affiliation': 'West China School of Basic Medical Sciences and Forensic Medicine, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Xiao Cheng', 'Initials': 'XC', 'LastName': 'Hu', 'Affiliation': 'Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co. Ltd, Tianjin, 300301, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'GCP Center, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Fan', 'Affiliation': 'Chongqing Fagen Biomedical INC., Chongqing, 400010, China.'}, {'ForeName': 'Yong Ming', 'Initials': 'YM', 'LastName': 'Cai', 'Affiliation': 'Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co. Ltd, Tianjin, 300301, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'GCP Center, West China Hospital of Sichuan University, Chengdu, 610041, China. lzheng2005618@163.com.'}]",CNS drugs,['10.1007/s40263-019-00628-0']
246,31233896,Relationship between change in in-vivo exposure distress and PTSD symptoms during exposure therapy for active duty soldiers.,"OBJECTIVE


The current study sought to examine the relationship between changes in distress for items on in-vivo exposure hierarchies and posttraumatic stress disorder (PTSD) symptom change over the course of exposure therapy.
METHODS


Active duty army soldiers (N = 108) were recruited from a military base in the U.S. and were enrolled in a randomized clinical trial comparing Prolonged Exposure (PE), Virtual Reality Exposure (VRE), and a wait-list control for the treatment of PTSD stemming from deployments to Iraq or Afghanistan. PTSD diagnosis followed DSM-IV-TR criteria. Outcome measures were assessed via self-report and clinician interview. The relationships between in-vivo exposure distress, imaginal exposure distress, and PTSD symptoms, were examined in a factor of curves model for participants in the treatment conditions.
RESULTS


Analyses revealed that, when controlling for one another, changes in in-vivo exposure distress were significantly associated with changes in PTSD symptoms (β = 0.75, 95% CI [0.60, 0.90]), while changes in imaginal exposure distress were not (β = 0.03, 95% CI [-0.27, 0.33]). The model also revealed that after accounting for the shared variation in trajectories of change, symptom clusters did not have unique variation, meaning that symptom clusters did not change independently.
CONCLUSION


Results suggest the possibility that in-vivo exposures are more closely tied to changes in overall PTSD symptoms than imaginal exposures during exposure therapy. Furture research should incorporate more frequent measurement of in-vivo exposure distress to better elucidate these relations over the course of treatment.",2019,"RESULTS


Analyses revealed that, when controlling for one another, changes in in-vivo exposure distress were significantly associated with changes in PTSD symptoms (β = 0.75, 95% CI [0.60, 0.90]), while changes in imaginal exposure distress were not (β = 0.03, 95% CI [-0.27, 0.33]).",['Active duty army soldiers (N\u202f=\u202f108) were recruited from a military base in the U.S'],"['Prolonged Exposure (PE), Virtual Reality Exposure (VRE), and a wait-list control for the treatment of PTSD stemming from deployments to Iraq or Afghanistan']","['vivo exposure distress, imaginal exposure distress, and PTSD symptoms', 'imaginal exposure distress', 'via self-report and clinician interview', 'PTSD symptoms', 'overall PTSD symptoms', 'vivo exposure distress']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C2936504', 'cui_str': 'Military Bases'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",108.0,0.0168456,"RESULTS


Analyses revealed that, when controlling for one another, changes in in-vivo exposure distress were significantly associated with changes in PTSD symptoms (β = 0.75, 95% CI [0.60, 0.90]), while changes in imaginal exposure distress were not (β = 0.03, 95% CI [-0.27, 0.33]).","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'VISN 20 Northwest Network Mental Illness Research, Education and Clinical Center (MIRECC), USA; University of Washington School of Medicine, USA.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Health Care System, USA; University of Arizona, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Stevens', 'Affiliation': 'VA Puget Sound Health Care System, USA; University of Illinois at Chicago, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hawrilenko', 'Affiliation': 'VA Puget Sound Health Care System, USA; University of Washington School of Medicine, USA.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Michael', 'Affiliation': 'VA Puget Sound Health Care System, USA; University of Washington School of Medicine, USA.'}, {'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Health Care System, USA; University of Washington School of Medicine, USA. Electronic address: Greg.Reger@va.gov.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.06.013']
247,31238203,Prevalence of obstructive sleep apnea in suicidal patients with major depressive disorder.,"In this paper, we report the rate of previously undiagnosed obstructive sleep apnea (OSA) in a randomized clinical trial (RCT) of suicidal patients with major depressive disorder (MDD). One hundred and twenty-five suicidal adults with MDD were recruited into a RCT. None were suspected to have OSA. Fourteen percent met diagnostic criteria for OSA. The Apnea Hypopnea Index (AHI) was predicted by increasing age, male sex, and higher Body Mass Index. However, neither the degree of daytime sleepiness nor the degree of insomnia predicted AHI severity. A high degree of suspicion is warranted for OSA in suicidal patients with MDD, and for patients with treatment-resistant depression. ClinicalTrials.gov identifier: NCT01689909.",2019,"The Apnea Hypopnea Index (AHI) was predicted by increasing age, male sex, and higher Body Mass Index.","['suicidal patients with major depressive disorder', 'One hundred and twenty-five suicidal adults with MDD', 'suicidal patients with major depressive disorder (MDD', 'suicidal patients with MDD, and for patients with treatment-resistant depression']",[],"['daytime sleepiness', 'Apnea Hypopnea Index (AHI', 'undiagnosed obstructive sleep apnea (OSA', 'obstructive sleep apnea']","[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]",[],"[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",125.0,0.0193191,"The Apnea Hypopnea Index (AHI) was predicted by increasing age, male sex, and higher Body Mass Index.","[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'The Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA, USA. Electronic address: wmccall@augusta.edu.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Benca', 'Affiliation': 'Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine, CA, USA. Electronic address: rbenca@uci.edu.'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Rumble', 'Affiliation': 'Department of Psychiatry, University of Wisconsin, Madison, WI, USA. Electronic address: rumble@wisc.edu.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Case', 'Affiliation': '. Department of Biostatistics and Data Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: dcase@wakehealth.edu.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'The Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA. Electronic address: andrew.krystal@ucsf.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.06.015']
248,30730430,Clinical Outcome After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: A Randomized Clinical Pilot Study.,"STUDY DESIGN


Pilot, single-center, single-blinded, parallel-group, randomized clinical study.
OBJECTIVE


The aim of this study was to pilot a randomized clinical study to evaluate whether instrumented anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) leads to superior radiologic and clinical outcomes at 12-month follow-up compared with instrumented ALIF with homologous bone.
SUMMARY OF BACKGROUND DATA


ALIF completed with interbody cages is an established technique for performing arthrodesis of the lumbar spine. There is ongoing discussion about which cage-filling material is most appropriate. This is the first study to assess the efficacy of NH-SiO2 in ALIF surgery.
MATERIALS AND METHODS


This randomized, clinical, pilot trial included 2 groups of 20 patients with monosegmental or multisegmental degenerative disease of the lumbar spine who were suitable to undergo monosegmental or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homogenous bone. Primary outcome was postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary outcomes were postoperative radiographic outcomes, pain, and quality of life. Patients were followed 12 months postoperatively.
RESULTS


Mean (±SD) 12-month ODI was 24±17 in the NH-SiO2 group and 27±19 in the homologous bone group (P=0.582). Postoperative radiography, functional outcomes, and quality-of-life indices did not differ significantly between groups at any of the regularly scheduled follow-up visits.
CONCLUSIONS


This clinical study showed similar functional, radiologic, and clinical outcomes 12 months postoperatively for instrumented ALIF procedures with the use of NH-SiO2 or homologous bone as cage filling. In the absence of any relevant differences in outcome, we postulate that the pivotal clinical study should be designed as an equivalence trial.",2019,"Postoperative radiography, functional outcomes, and quality-of-life indices did not differ significantly between groups at any of the regularly scheduled follow-up visits.
",['2 groups of 20 patients with monosegmental or multisegmental degenerative disease of the lumbar spine who were suitable to undergo monosegmental or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homogenous bone'],"['instrumented anterior lumbar interbody fusion (ALIF', 'Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material', 'NH-SiO2']","['postoperative radiographic outcomes, pain, and quality of life', 'Postoperative radiography, functional outcomes, and quality-of-life indices', 'Mean (±SD', 'postoperative disability as measured by the Oswestry Disability Index (ODI', '12-month ODI']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0108411', 'cui_str': 'Carbon Felt'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0541042', 'cui_str': '(PMMA)-SiO2'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0243003', 'cui_str': 'Bone Replacement Materials'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0541042', 'cui_str': '(PMMA)-SiO2'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",20.0,0.103714,"Postoperative radiography, functional outcomes, and quality-of-life indices did not differ significantly between groups at any of the regularly scheduled follow-up visits.
","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Rickert', 'Affiliation': 'Orthopaedic University Hospital Friedrichsheim gGmbH, Frankfurt am Main.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Fleege', 'Affiliation': 'Orthopaedic University Hospital Friedrichsheim gGmbH, Frankfurt am Main.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Papachristos', 'Affiliation': 'Orthopaedic University Hospital Friedrichsheim gGmbH, Frankfurt am Main.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Makowski', 'Affiliation': 'Department of Radiology and Neuroradiology, Charité-University, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rauschmann', 'Affiliation': 'Orthopaedic University Hospital Friedrichsheim gGmbH, Frankfurt am Main.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Arabmotlagh', 'Affiliation': 'Orthopaedic University Hospital Friedrichsheim gGmbH, Frankfurt am Main.'}]",Clinical spine surgery,['10.1097/BSD.0000000000000802']
249,31562800,Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer.,"BACKGROUND


Data are limited regarding the use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors, such as veliparib, in combination with chemotherapy followed by maintenance as initial treatment in patients with high-grade serous ovarian carcinoma.
METHODS


In an international, phase 3, placebo-controlled trial, we assessed the efficacy of veliparib added to first-line induction chemotherapy with carboplatin and paclitaxel and continued as maintenance monotherapy in patients with previously untreated stage III or IV high-grade serous ovarian carcinoma. Patients were randomly assigned in a 1:1:1 ratio to receive chemotherapy plus placebo followed by placebo maintenance (control), chemotherapy plus veliparib followed by placebo maintenance (veliparib combination only), or chemotherapy plus veliparib followed by veliparib maintenance (veliparib throughout). Cytoreductive surgery could be performed before initiation or after 3 cycles of trial treatment. Combination chemotherapy was 6 cycles, and maintenance therapy was 30 additional cycles. The primary end point was investigator-assessed progression-free survival in the veliparib-throughout group as compared with the control group, analyzed sequentially in the  BRCA -mutation cohort, the cohort with homologous-recombination deficiency (HRD) (which included the  BRCA -mutation cohort), and the intention-to-treat population.
RESULTS


A total of 1140 patients underwent randomization. In the  BRCA -mutation cohort, the median progression-free survival was 34.7 months in the veliparib-throughout group and 22.0 months in the control group (hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.28 to 0.68; P<0.001); in the HRD cohort, it was 31.9 months and 20.5 months, respectively (hazard ratio, 0.57; 95 CI, 0.43 to 0.76; P<0.001); and in the intention-to-treat population, it was 23.5 months and 17.3 months (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). Veliparib led to a higher incidence of anemia and thrombocytopenia when combined with chemotherapy as well as of nausea and fatigue overall.
CONCLUSIONS


Across all trial populations, a regimen of carboplatin, paclitaxel, and veliparib induction therapy followed by veliparib maintenance therapy led to significantly longer progression-free survival than carboplatin plus paclitaxel induction therapy alone. The independent value of adding veliparib during induction therapy without veliparib maintenance was less clear. (Funded by AbbVie; VELIA/GOG-3005 ClinicalTrials.gov number, NCT02470585.).",2019,"Veliparib led to a higher incidence of anemia and thrombocytopenia when combined with chemotherapy as well as of nausea and fatigue overall.
","['patients with previously untreated stage III or IV high-grade serous ovarian carcinoma', '1140 patients underwent randomization', 'patients with high-grade serous ovarian carcinoma', 'Ovarian Cancer']","['Veliparib with First-Line Chemotherapy', 'carboplatin, paclitaxel, and veliparib induction therapy', 'Combination chemotherapy', 'chemotherapy plus placebo followed by placebo maintenance (control), chemotherapy plus veliparib followed by placebo maintenance (veliparib combination only), or chemotherapy plus veliparib followed by veliparib maintenance (veliparib throughout', 'placebo', 'veliparib added to first-line induction chemotherapy with carboplatin and paclitaxel', 'carboplatin plus paclitaxel', 'poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors', 'Cytoreductive surgery']","['nausea and fatigue overall', 'investigator-assessed progression-free survival', 'longer progression-free survival', 'anemia and thrombocytopenia', 'median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0029925'}, {'cui': 'C4517539', 'cui_str': 'One thousand one hundred and forty'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0032405', 'cui_str': 'Poly(ADPR) Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1140.0,0.406613,"Veliparib led to a higher incidence of anemia and thrombocytopenia when combined with chemotherapy as well as of nausea and fatigue overall.
","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Karina D', 'Initials': 'KD', 'LastName': 'Steffensen', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Aikou', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Efrat Ben-Baruch', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Werner', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Noelle G', 'Initials': 'NG', 'LastName': 'Cloven', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Morgan', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Joo-Hyun', 'Initials': 'JH', 'LastName': 'Nam', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Leath', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Shibani', 'Initials': 'S', 'LastName': 'Nicum', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Hagemann', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Ramey D', 'Initials': 'RD', 'LastName': 'Littell', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Baron-Hay', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Garcia-Donas', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Mizuno', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bell-McGuinn', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Bach', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Sudipta', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Ratajczak', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ansell', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Minh H', 'Initials': 'MH', 'LastName': 'Dinh', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bookman', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C.); University of Chicago Medicine (G.F.F.) and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (D.C.), Chicago, and AbbVie, North Chicago (D.M.S., B.A.B., S.B., C.K.R., P.J.A., M.H.D.) - all in Illinois; NRG Oncology Statistical and Data Center, Roswell Park Cancer Institute, Buffalo (M.F.B.), and Memorial Sloan Kettering Cancer Center, New York (K.B.-M., C.A.) - both in New York; University of Washington-Seattle Cancer Care Alliance, Seattle (E.M.S.); Lillebaelt University Hospital of Southern Denmark, Vejle, and the University of Southern Denmark, Odense (K.D.S.); Prince of Wales Clinical School, University of New South Wales and Royal Hospital for Women (M.F.), and the Northern Cancer Institute (S.B.-H.), Sydney; Jikei University School of Medicine, Tokyo (A. Okamoto), and Aichi Cancer Center Hospital, Nagoya (M.M.) - both in Japan; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City (K.N.M.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); Huntsman Cancer Institute, University of Utah, Salt Lake City (T.L.W.); Texas Oncology, U.S. Oncology Research Network, Fort Worth (N.G.C.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (A. Oaknin); Women and Infants Hospital, Providence, RI (P.A.D.); Penn Medicine, Philadelphia (M.A.M.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-H.N.); O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham (C.A.L.); Oxford University Hospitals, Oxford, United Kingdom (S.N.); Washington University School of Medicine, St. Louis (A.R.H.); Kaiser Permanente Northern California, San Francisco (R.D.L., M.A.B.); and H.M. Hospitales-Centro Integral Oncológico H.M. Clara Campal, Madrid (J.G.-D.).""}]",The New England journal of medicine,['10.1056/NEJMoa1909707']
250,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES


Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS


In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS


Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS


Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
251,31852769,"Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.","OBJECTIVE


Faecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.
DESIGN


This randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.
RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms.
CONCLUSIONS


FMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose.  Trial registration  www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).",2020,"RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","['patients with IBS', 'patients with irritable bowel syndrome', '165 patients with IBS to placebo (own faeces), 30\u2009g FMT or 60\u2009g FMT at a ratio of 1:1:1', 'healthy donors to patients with irritable bowel syndrome (IBS']","['faecal microbiota transplantation', 'FMT', 'placebo', 'Faecal microbiota transplantation (FMT', 'www.cristin.no']","['IBS symptoms', 'reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing', 'intestinal bacterial profiles', 'fatigue and the quality of life', 'total IBS symptom score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",165.0,0.430062,"RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Salhy', 'Affiliation': 'Stord Hospital, Stord, Norway magdy.elsalhy@sklbb.no.'}, {'ForeName': 'Jan Gunnar', 'Initials': 'JG', 'LastName': 'Hatlebakk', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Odd Helge', 'Initials': 'OH', 'LastName': 'Gilja', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bråthen Kristoffersen', 'Affiliation': 'Genetic Analysis As, Oslo, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}]",Gut,['10.1136/gutjnl-2019-319630']
252,32276783,Comparative Effectiveness of Functional Tests in Fall Prediction After Hip Fracture.,"OBJECTIVES


To assess the validity of 4 functional tests in predicting falls within the first year after hip fracture.
DESIGN


Prospective study of functional tests shortly after hip surgery and incident falls during 12 months' follow-up.
SETTING AND PARTICIPANTS


The sample comprised 173 adults with acute hip fracture, aged 65 years and older (79% women, 77% community dwelling, mean age 84.2 years), who participated in a clinical trial of vitamin D or home exercise.
METHODS


We assessed 4 functional tests [Timed Up and Go test (TUG), grip strength, and knee flexor and extensor strength in the nonoperated leg] by trained study physiotherapists at baseline (1-12 days after hip fracture surgery). During 12 months' follow-up, we ascertained all fall events by monthly personal phone calls, a telephone hotline, and a patient diary. Then we compared TUG and strength test performance at baseline between future single fallers, recurrent fallers, and nonfallers over the 12-month follow-up. All analyses adjusted for age, body mass index, gender, 25-hydroxyvitamin D status at baseline, days of follow-up, and treatment allocation (the original trial tested vitamin D treatment and/or a home exercise program).
RESULTS


Ninety-two of 173 (53%) participants fell and experienced 212 falls. Participants who became recurrent fallers (n = 54) had significantly longer TUG times at baseline than those who did not fall (n = 81) in the following 12 months (mean TUG for recurrent fallers = 71.6 seconds, SD = 8.2 seconds, vs mean TUG for nonfallers = 51.4 seconds, SD = 6.9 seconds; P = .02). There were no significant differences in TUG times between single fallers and nonfallers. For all 3 strength tests, there were no significant differences between single fallers, recurrent fallers, and nonfallers.
CONCLUSIONS AND IMPLICATIONS


In this population of frail older adults recruited shortly after hip fracture surgery, only the TUG test discriminated between future recurrent fallers and nonfallers over a 12-month follow-up. Because of the high incidence and serious consequences of falls in older adults after a hip fracture, it is very important to identify practical and clinically related tests to predict repeated falls in the first year after a hip fracture, which is of great public health importance.",2020,"For all 3 strength tests, there were no significant differences between single fallers, recurrent fallers, and nonfallers.
","['frail older adults', 'participants fell and experienced 212 falls', '173 adults with acute hip fracture, aged 65\xa0years and older (79% women, 77% community dwelling, mean age 84.2\xa0years), who participated in a clinical trial of vitamin D or home exercise', ""hip surgery and incident falls during 12\xa0months' follow-up"", 'Ninety-two of 173 (53', 'Participants who became recurrent fallers (n\xa0=\xa054', 'older adults after a hip fracture', 'predicting falls within the first year after hip fracture']",[],"['single fallers, recurrent fallers, and nonfallers', '4 functional tests [Timed Up and Go test (TUG), grip strength, and knee flexor and extensor strength', 'TUG times', 'longer TUG times']","[{'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",173.0,0.0539834,"For all 3 strength tests, there were no significant differences between single fallers, recurrent fallers, and nonfallers.
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wald', 'Affiliation': 'Centre on Aging and Mobility, University Hospital Zurich, Waid City Hospital, and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patricia O', 'Initials': 'PO', 'LastName': 'Chocano-Bedoya', 'Affiliation': 'Centre on Aging and Mobility, University Hospital Zurich, Waid City Hospital, and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ursina', 'Initials': 'U', 'LastName': 'Meyer', 'Affiliation': 'Centre on Aging and Mobility, University Hospital Zurich, Waid City Hospital, and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Endel J', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Centre on Aging and Mobility, University Hospital Zurich, Waid City Hospital, and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Centre on Aging and Mobility, University Hospital Zurich, Waid City Hospital, and University of Zurich, Zurich, Switzerland; Department of Geriatrics, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Centre on Aging and Mobility, University Hospital Zurich, Waid City Hospital, and University of Zurich, Zurich, Switzerland; Department of Geriatrics, University Hospital Zurich, Zurich, Switzerland; University Clinic for Acute Geriatric Care, Waid City Hospital, Zurich, Switzerland. Electronic address: heike.bischoff@usz.ch.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.02.008']
253,31470740,Feasibility Studies of an Insulin-Only Bionic Pancreas in a Home-Use Setting.,"BACKGROUND


We tested the safety and performance of the ""insulin-only"" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points.
METHOD


This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis.
RESULTS


Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL,  P  = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL,  P  = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time <70 mg/dL with both the static (1.8% ± 1.4%,  P  = .009) and dynamic set-point (2.7±1.5,  P  = .051) arms compared to the usual-care arm (5.5% ± 4.2%). HF testing demonstrated preliminary user satisfaction and no increased risk of diabetes burden or distress.
CONCLUSIONS


The insulin-only configuration of the BP using either static or dynamic set-points and initialized only with body weight performed similarly to other published insulin-only systems.",2019,There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms.,"['Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg']","['Insulin-Only Bionic Pancreas', 'insulin-only"" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system']","['risk of diabetes burden or distress', 'time spent']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005549', 'cui_str': 'Bionics'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",13.0,0.0292158,There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms.,"[{'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Nally', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Firas H', 'Initials': 'FH', 'LastName': 'El-Khatib', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA, USA.'}, {'ForeName': 'Trang T', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Clinton', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Molly L', 'Initials': 'ML', 'LastName': 'Tanenbaum', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Hanes', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Rajendranath R', 'Initials': 'RR', 'LastName': 'Selagamsetty', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA, USA.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Damiano', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Journal of diabetes science and technology,['10.1177/1932296819872225']
254,32276098,Phase 3 Study of Palonosetron IV Infusion Vs. IV Bolus for Chemotherapy-Induced Nausea and Vomiting Prophylaxis After Highly Emetogenic Chemotherapy.,"CONTEXT


Palonosetron (PALO) is one of the two active components of NEPA, the fixed-combination antiemetic comprising netupitant (oral)/fosnetupitant (IV) and PALO. To increase the convenience of NEPA administration, especially for patients with swallowing difficulties, an IV NEPA formulation has been developed, where PALO is administered as a 30-minute infusion instead of the approved 30-second bolus.
OBJECTIVES


To determine the efficacy and safety of the PALO component used in IV NEPA.
METHODS


Noninferiority, double-blind, and randomized Phase 3 trial in chemotherapy-naive adult patients with cancer requiring highly emetogenic chemotherapy. Patients were randomized to receive a single dose of PALO 0.25 mg administered IV either as a 30-minute infusion or as a 30-second bolus before highly emetogenic chemotherapy. The primary objective was to demonstrate noninferiority of the 30-minute infusion vs. 30-second bolus in terms of complete response (CR; no emesis and no rescue medication) in the acute phase. Secondary efficacy endpoints were CR in the delayed and overall phases and no emesis and no rescue medication in all phases. Safety was a secondary endpoint.
RESULTS


Overall, 440 patients received study treatment. In the infusion group, 186 (82.7%) patients reported CR in the acute phase vs. 186 (86.5%) patients in the bolus group, demonstrating the noninferiority of PALO infusion vs. bolus (P < 0.001). Secondary endpoints showed similar results between the two treatment groups.
CONCLUSION


PALO 0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase. These results support the use of PALO 0.25 mg as a component of IV NEPA.",2020,0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase.,"['naive adult cancer patients requiring highly emetogenic chemotherapy (HEC', '440 patients received study treatment', 'patients with swallowing difficulties']","['chemotherapy', 'palonosetron intravenous (IV) infusion versus IV bolus for chemotherapy', 'PALO']","['CR in the delayed and overall phases, and no emesis and no rescue medication', 'complete response (CR; no emesis, no rescue medication', 'nausea and vomiting prophylaxis', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.119251,0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase.,"[{'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Neuperlach/Klinikum Harlaching, Munich, Germany. Electronic address: meinolf.karthaus@klinikum-muenchen.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Voisin', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland; Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Institute of Oncology Prof. Dr. Ion Chiricuţã and UMF Iuliu Haţieganu, Cluj-Napoca, Romania.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.03.034']
255,32275852,Storytelling Through Music: A Multidimensional Expressive Arts Intervention to Improve Emotional Well-Being of Oncology Nurses.,"PURPOSE


Rates of burnout among health care professionals are rising. Oncology nurses are at the forefront of cancer care, and maintenance of their well-being is crucial to delivering high-quality care to people with cancer. The purpose of this pilot study was to implement a novel intervention, Storytelling Through Music, and examine the effects on depression, insomnia, loneliness, self-awareness, self-compassion, burnout, secondary traumatic stress, and compassion satisfaction in oncology nurses.
METHODS


This two-group (intervention and control), quasi-experimental study of a 6-week intervention combined storytelling, reflective writing, songwriting, and stress management skills.
RESULTS


Participants (N = 43) were predominately white (98%), with 27% reporting Hispanic ethnicity, and female (95%); their average oncology experience was 8.5 years. Both groups improved significantly over time on all measures. Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46;  P  < .001) and insomnia ( F [3, 120] = 5.77;  P  < .001) and greater self-compassion ( F [3, 105] = 2.88;  P  < .05) and self-awareness ( F [3, 120] = 2.42;  P  < .10).
CONCLUSION


There are few opportunities for health care professionals to reflect on the impact of caregiving. The Storytelling Through Music intervention provided a structured space for reflection by participants, individually and among their peers, which decreased loneliness and increased self-compassion. Both factors relate to the burnout that affects the oncology health care workforce.",2020,"Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46;  P  < .001) and insomnia ( F [3, 120] = 5.77;  P  < .001) and greater self-compassion ( F [3, 105] = 2.88;  P  < .05) and self-awareness ( F [3, 120] = 2.42;  P  < .10).
","['Participants (N = 43) were predominately white (98%), with 27% reporting Hispanic ethnicity, and female (95%); their average oncology experience was 8.5 years']","['intervention combined storytelling, reflective writing, songwriting, and stress management skills', 'Storytelling Through Music', 'Multidimensional Expressive Arts Intervention']","['insomnia', 'loneliness', 'self-awareness', 'depression, insomnia, loneliness, self-awareness, self-compassion, burnout, secondary traumatic stress, and compassion satisfaction', 'greater self-compassion']","[{'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",43.0,0.0259643,"Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46;  P  < .001) and insomnia ( F [3, 120] = 5.77;  P  < .001) and greater self-compassion ( F [3, 105] = 2.88;  P  < .05) and self-awareness ( F [3, 120] = 2.42;  P  < .10).
","[{'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Phillips', 'Affiliation': 'The Phyllis F. Cantor Center for Research in Nursing and Patient Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Volker', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Davidson', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}]",JCO oncology practice,['10.1200/JOP.19.00748']
256,32277872,"Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001) in the treatment of irritable bowel syndrome: a multicentre, randomised, double-blind, placebo-controlled clinical trial.","BACKGROUND


Bifidobacterium bifidum MIMBb75 is one of a few probiotic strains that have been shown to be effective in the treatment of irritable bowel syndrome (IBS) and its symptoms. Non-viable strains might have advantages over viable bacteria for product stability and standardisation, as well as for tolerability because safety concerns have been raised for specific patient groups who are susceptible to infection. We aimed to assess the efficacy of non-viable, heat-inactivated (HI) B bifidum MIMBb75 (SYN-HI-001) in the treatment of IBS and its symptoms.
METHODS


We did a double-blind, placebo-controlled trial in which patients with IBS were recruited from 20 study sites in Germany and randomly assigned to receive either two placebo capsules or two capsules with a combined total of 1 × 10 9  non-viable B bifidum HI-MIMBb75 cells to be taken orally once a day for 8 weeks. Eligible patients were diagnosed with IBS according to Rome III criteria and had abdominal pain (≥4 on an 11-point numerical rating scale) on at least 2 days during a 2-week run-in phase. Patients with chronic inflammatory bowel diseases, systemic diseases, cancer, autoimmune diseases, with an intake of antipsychotic medications 3 months before study start, or with an intake of systemic corticosteroids within 1 month before study start were excluded. Randomisation was in a 1:1 ratio according to a computer-generated blocked list. Patients, investigators, clinical monitors, project managers, and statisticians were masked to the randomisation. The primary composite endpoint was the combination of at least 30% improvement of abdominal pain and adequate relief of overall IBS symptoms being fulfilled in at least 4 of 8 weeks during treatment. Analysis of the primary endpoint included all randomly assigned patients receiving at least one dose of study medication and who had no severe protocol violation. Safety analysis included all patients who had taken at least one dose of the study medication and was based on frequency and severity of adverse events, laboratory evaluation, and global assessment of tolerability. This trial is registered with the ISRCTN registry, ISRCTN14066467, and is completed: the results shown here represent the final analysis.
FINDINGS


Patients were screened between April 15, 2016, and Feb 3, 2017, and 443 patients were allocated to the placebo group (n=222) or the B bifidum HI-MIMBb75 group (n=221). The composite primary endpoint was reached by 74 (34%) of 221 patients in the B bifidum HI-MIMBb75 group compared with 43 (19%) of 222 in the placebo group (risk ratio 1·7, 95% CI 1·3-2·4; p=0·0007). No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group. No deaths were reported in this study. The most common reported adverse event with a suspected relationship to the study product was abdominal pain, which was reported in two (<1%) patients in the B bifidum HI-MIMBb75 group and one (<1%) in the placebo group. Tolerability was rated as very good or good by 200 (91%) patients in the B bifidum HI-MIMBb75 group compared with 191 (86%) in the placebo group.
INTERPRETATION


This study shows that B bifidum HI-MIMBb75 substantially alleviates IBS and its symptoms in a real-life setting. These results indicate that specific beneficial bacterial effects are mediated independently of cell viability.
FUNDING


Synformulas.",2020,No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group.,"['Patients were screened between April 15, 2016, and Feb 3, 2017, and 443 patients', 'Patients with chronic inflammatory bowel diseases, systemic diseases, cancer, autoimmune diseases, with an intake of antipsychotic medications 3 months before study start, or with an intake of systemic corticosteroids within 1 month before study start were excluded', 'irritable bowel syndrome', 'patients with IBS were recruited from 20 study sites in Germany', 'patients who had taken at least one dose of the study medication and was based on', 'Eligible patients were diagnosed with IBS according to Rome III criteria and had abdominal pain (≥4 on an 11-point numerical rating scale) on at least 2 days during a 2-week run-in phase']","['Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001', 'placebo capsules or two capsules with a combined total of 1\u2008×\u200810 9  non-viable B bifidum HI-MIMBb75 cells', 'placebo', 'B bifidum HI-MIMBb75', 'non-viable, heat-inactivated (HI) B bifidum MIMBb75 (SYN-HI-001']","['combination of at least 30% improvement of abdominal pain and adequate relief of overall IBS symptoms', 'Tolerability', 'frequency and severity of adverse events, laboratory evaluation, and global assessment of tolerability', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.363173,No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group.,"[{'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Andresen', 'Affiliation': 'Department of Internal Medicine, Israelitic Hospital, University of Hamburg Teaching Hospital, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gschossmann', 'Affiliation': 'Department of Internal Medicine, Hospital Forchheim, Forchheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Layer', 'Affiliation': 'Department of Internal Medicine, Israelitic Hospital, University of Hamburg Teaching Hospital, Hamburg, Germany. Electronic address: p.layer@ik-h.de.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30056-X']
257,32231295,A randomized proof-of-mechanism trial applying the 'fast-fail' approach to evaluating κ-opioid antagonism as a treatment for anhedonia.,"The National Institute of Mental Health (NIMH) 'fast-fail' approach seeks to improve too-often-misleading early-phase drug development methods by incorporating biomarker-based proof-of-mechanism (POM) testing in phase 2a. This first comprehensive application of the fast-fail approach evaluated the potential of κ-opioid receptor (KOR) antagonism for treating anhedonia with a POM study determining whether robust target engagement favorably impacts the brain circuitry hypothesized to mediate clinical effects. Here we report the results from a multicenter, 8-week, double-blind, placebo-controlled, randomized trial in patients with anhedonia and a mood or anxiety disorder (selective KOR antagonist (JNJ-67953964, 10 mg; n = 45) and placebo (n = 44)). JNJ-67953964 significantly increased functional magnetic resonance imaging (fMRI) ventral striatum activation during reward anticipation (primary outcome) as compared to placebo (baseline-adjusted mean: JNJ-67953964, 0.72 (s.d. = 0.67); placebo, 0.33 (s.d. = 0.68); F(1,86) = 5.58, P < 0.01; effect size = 0.58 (95% confidence interval, 0.13-0.99)). JNJ-67953964, generally well tolerated, was not associated with any serious adverse events. This study supports proceeding with assessment of the clinical impact of target engagement and serves as a model for implementing the 'fast-fail' approach.",2020,"significantly increased functional magnetic resonance imaging (fMRI) ventral striatum activation during reward anticipation (primary outcome) as compared to placebo (baseline-adjusted mean: JNJ-67953964, 0.72 (s.d. = 0.67); placebo, 0.33 (s.d. = 0.68); F(1,86) = 5.58, P < 0.01; effect size = 0.58 (95% confidence interval, 0.13-0.99)).","['patients with anhedonia and a mood or anxiety disorder (selective KOR antagonist (JNJ-67953964, 10\u2009mg; n\u2009=\u200945) and', 'n\u2009=\u200944']","['placebo', 'κ-opioid receptor (KOR) antagonism', 'JNJ-67953964']","['serious adverse events', 'functional magnetic resonance imaging (fMRI) ventral striatum activation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034801', 'cui_str': 'Receptors, Opiate'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",,0.474631,"significantly increased functional magnetic resonance imaging (fMRI) ventral striatum activation during reward anticipation (primary outcome) as compared to placebo (baseline-adjusted mean: JNJ-67953964, 0.72 (s.d. = 0.67); placebo, 0.33 (s.d. = 0.68); F(1,86) = 5.58, P < 0.01; effect size = 0.58 (95% confidence interval, 0.13-0.99)).","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA. andrew.krystal@ucsf.edu.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Smoski', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nurnberger', 'Affiliation': 'Departments of Psychiatry and Neurobiology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Department of Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Weiner', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Richard S E', 'Initials': 'RSE', 'LastName': 'Keefe', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Song', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Goodman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Psychiatry, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}]",Nature medicine,['10.1038/s41591-020-0806-7']
258,32279363,Effects of the FIFA 11+ on injury prevention in amateur futsal players.,"OBJECTIVE


To examine the effectiveness of the FIFA 11+ in reducing injury in futsal players.
METHODS


Ninety-one male futsal players from six amateur futsal clubs were recruited and assessed for eligibility, and 71 were randomized to the 11+ group (n = 37, age: 27.0 ± 5.1 years) and a control group (n = 34, age: 26.0 ± 5.1 years). The 11+ program was executed twice a week for 20 weeks, separated by a 10-week period where both groups executed their regular warm-up. Data on match, training exposure, and injuries were recorded during the regular season.
RESULTS


The players sustained a total of 58 injuries during the futsal regular season, with 24 injuries in the 11+ group and 34 injuries in the control group; the overall incidence of injuries per 1000 player-hours was significantly higher in the control group (11.6 vs 6.5; mean difference (95% CI) -5.1 (-9.1 to -1.1), P = .014). The 11+ group had a significantly lower incidence of acute (11.2 vs 5.7; -5.5 (-9.4 to -1.6), P = .007) and lower limb (8.7 vs 4.4; -4.2 (-8.1 to -0.4), P = .032) injuries per 1000 player-hours. Players from the control group had a higher number of days injured (20.4 ± 17.3 vs 10.5 ± 9.1, P = .036).
CONCLUSION


The FIFA 11+ is an injury prevention program suited for injury reduction in amateur futsal players, as it reduces the incidence of overall, acute, and lower limb injuries during the season.",2020,"Players from the control group had a higher number of days injured (20.4 ± 17.3 vs. 10.5 ± 9.1, p=0.036).
","['amateur futsal players', 'Ninety-one male futsal players from six amateur futsal clubs were recruited and assessed for eligibility, and 71 were randomized to the 11+ group (n=37, age: 27.0±5.1 years) and a control group (n=34, age: 26.0±5.1 years']",['FIFA 11'],"['lower limb', 'overall incidence of injuries per 1000 player-hours', 'incidence of acute']","[{'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",91.0,0.0337759,"Players from the control group had a higher number of days injured (20.4 ± 17.3 vs. 10.5 ± 9.1, p=0.036).
","[{'ForeName': 'Mário', 'Initials': 'M', 'LastName': 'Lopes', 'Affiliation': 'School of Health Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Simões', 'Affiliation': 'Santa Maria Health School, Porto, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'School of Health Sciences and CINTESIS@UA, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'School of Health Sciences and Institute of Biomedicine - iBiMED, University of Aveiro, Aveiro, Portugal.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13677']
259,31939785,"Family Care Rituals in the ICU to Reduce Symptoms of Post-Traumatic Stress Disorder in Family Members-A Multicenter, Multinational, Before-and-After Intervention Trial.","OBJECTIVES


To assess the feasibility and efficacy of implementing ""Family Care Rituals"" as a means of engaging family members in the care of patients admitted to the ICU with a high risk of ICU mortality on outcomes including stress-related symptoms in family members.
DESIGN


Prospective, before-and-after intervention evaluation.
SETTING


Two U.S. academic medical ICU's, and one Italian academic medical/surgical ICU.
SUBJECTS


Family members of patients who had an attending predicted ICU mortality of greater than 30% within the first 24 hours of admission.
INTERVENTIONS


A novel intervention titled ""Family Care Rituals"" during which, following a baseline observation period, family members enrolled in the intervention phase were given an informational booklet outlining opportunities for engagement in care of the patient during their ICU stay.
MEASUREMENTS AND MAIN RESULTS


Primary outcome was symptoms of post-traumatic stress disorder in family members 90 days after patient death or ICU discharge. Secondary outcomes included symptoms of depression, anxiety, and family satisfaction. At 90-day follow-up, 131 of 226 family members (58.0%) responded preintervention and 129 of 226 family members (57.1%) responded postintervention. Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046). There was no significant difference in symptoms of depression (26.5% vs 25.2%; unadjusted odds ratio, 0.93; p = 0.818), anxiety (41.0% vs 45.5%; unadjusted odds ratio, 1.20; p = 0.234), or mean satisfaction scores (85.1 vs 89.0; unadjusted odds ratio, 3.85; p = 0.052) preintervention versus postintervention 90 days after patient death or ICU discharge.
CONCLUSIONS


Offering opportunities such as family care rituals for family members to be involved with providing care for family members in the ICU was associated with reduced symptoms of post-traumatic stress disorder. This intervention may lessen the burden of stress-related symptoms in family members of ICU patients.",2020,"Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046).","[""Two U.S. academic medical ICU's, and one Italian academic medical/surgical ICU.\nSUBJECTS"", 'Family Members', 'family members of ICU patients', 'engaging family members in the care of patients admitted to the ICU with a high risk of ICU mortality on outcomes including stress-related symptoms in family members']","['implementing ""Family Care Rituals']","['symptoms of depression, anxiety, and family satisfaction', 'symptoms of depression', 'mean satisfaction scores', 'symptoms of post-traumatic stress disorder in family members 90 days after patient death or ICU discharge', 'ICU mortality', 'Symptoms of post-traumatic stress disorder', 'anxiety']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2945764', 'cui_str': 'Ritual (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0360186,"Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046).","[{'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Amass', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care & Sleep, Brown University, Providence, RI.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Villa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'OMahony', 'Affiliation': 'Department of Internal Medicine, Palliative Medicine Section, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Badger', 'Affiliation': 'Department of Psychiatry, Brown University, Providence, RI.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'McFadden', 'Affiliation': 'Department of Internal Medicine, Palliative Medicine Section, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Tanis', 'Initials': 'T', 'LastName': 'Caine', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'McGuirl', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Palmisciano', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Mei-Ean', 'Initials': 'ME', 'LastName': 'Yeow', 'Affiliation': 'Center for Palliative Care, Mayo Clinic, Rochester, NY.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Gaudio', 'Affiliation': 'Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Levy', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care & Sleep, Brown University, Providence, RI.'}]",Critical care medicine,['10.1097/CCM.0000000000004113']
260,30970186,Randomized Trial of Verubecestat for Prodromal Alzheimer's Disease.,"BACKGROUND


Prodromal Alzheimer's disease offers an opportunity to test the effect of drugs that modify the deposition of amyloid in the brain before the onset of dementia. Verubecestat is an orally administered β-site amyloid precursor protein-cleaving enzyme 1 (BACE-1) inhibitor that blocks production of amyloid-beta (Aβ). The drug did not prevent clinical progression in a trial involving patients with mild-to-moderate dementia due to Alzheimer's disease.
METHODS


We conducted a randomized, double-blind, placebo-controlled, 104-week trial to evaluate verubecestat at doses of 12 mg and 40 mg per day, as compared with placebo, in patients who had memory impairment and elevated brain amyloid levels but whose condition did not meet the case definition of dementia. The primary outcome was the change from baseline to week 104 in the score on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB; scores range from 0 to 18, with higher scores indicating worse cognition and daily function). Secondary outcomes included other assessments of cognition and daily function.
RESULTS


The trial was terminated for futility after 1454 patients had been enrolled; 485 had been assigned to receive verubecestat at a dose of 12 mg per day (the 12-mg group), 484 to receive verubecestat at a dose of 40 mg per day (the 40-mg group), and 485 to receive placebo. A total of 234 patients, 231 patients, and 239 patients per group, respectively, completed 104 weeks of the trial regimen. The estimated mean change from baseline to week 104 in the CDR-SB score was 1.65 in the 12-mg group, 2.02 in the 40-mg group, and 1.58 in the placebo group (P = 0.67 for the comparison between the 12-mg group and the placebo group and P = 0.01 for the comparison between the 40-mg group and the placebo group), suggesting a worse outcome in the higher-dose group than in the placebo group. The estimated rate of progression to dementia due to Alzheimer's disease was 24.5, 25.5, and 19.3 events per 100 patient-years in the 12-mg group, the 40-mg group, and the placebo group, respectively (hazard ratio for 40 mg vs. placebo, 1.38; 97.51% confidence interval, 1.07 to 1.79, not adjusted for multiple comparisons), favoring placebo. Adverse events were more common in the verubecestat groups than in the placebo group.
CONCLUSIONS


Verubecestat did not improve clinical ratings of dementia among patients with prodromal Alzheimer's disease, and some measures suggested that cognition and daily function were worse among patients who received verubecestat than among those who received placebo. (Funded by Merck Sharp & Dohme; ClinicalTrials.gov number, NCT01953601.).",2019,"The estimated mean change from baseline to week 104 in the CDR-SB score was 1.65 in the 12-mg group, 2.02 in the 40-mg group, and 1.58 in the placebo group (P = 0.67 for the comparison between the 12-mg group and the placebo group and P = 0.01 for the comparison between the 40-mg group and the placebo group), suggesting a worse outcome in the higher-dose group than in the placebo group.","['patients who had memory impairment and elevated brain amyloid levels but whose condition did not meet the case definition of dementia', '1454 patients had been enrolled; 485', ""patients with prodromal Alzheimer's disease"", 'A total of 234 patients, 231 patients, and 239 patients per group, respectively, completed 104 weeks of the trial regimen', ""patients with mild-to-moderate dementia due to Alzheimer's disease"", ""Prodromal Alzheimer's Disease""]",['placebo'],"['assessments of cognition and daily function', 'clinical ratings of dementia', 'Adverse events', 'CDR-SB score', ""estimated rate of progression to dementia due to Alzheimer's disease"", 'Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB; scores range']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3805054', 'cui_str': ""Prodromal Alzheimer's disease""}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",234.0,0.620926,"The estimated mean change from baseline to week 104 in the CDR-SB score was 1.65 in the 12-mg group, 2.02 in the 40-mg group, and 1.58 in the placebo group (P = 0.67 for the comparison between the 12-mg group and the placebo group and P = 0.01 for the comparison between the 40-mg group and the placebo group), suggesting a worse outcome in the higher-dose group than in the placebo group.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Egan', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kost', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Tiffini', 'Initials': 'T', 'LastName': 'Voss', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Aisen', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Cummings', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'van Dyck', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Boada', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Furtek', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mahoney', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Harper Mozley', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Mo', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Sur', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': ""From Merck, Kenilworth, NJ (M.F.E., J.K., T.V., Y. Mukai, Y.Z., W.L., C.F., E.M., L.H.M., Y. Mo, C.S., D.M.); the University of Southern California, San Diego (P.S.A.); Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas (J.L.C.); Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Gerontopole, INSERM Unité 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France (B.V.); Yale University School of Medicine, New Haven, CT (C.H.D.); and the Research Center and Memory Clínic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociènces Aplicades-Universitat Internacional de Catalunya, Barcelona, and the Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid - both in Spain (M.B.).""}]",The New England journal of medicine,['10.1056/NEJMoa1812840']
261,31545048,Site-Specific Glycoprofiles of HDL-Associated ApoE are Correlated with HDL Functional Capacity and Unaffected by Short-Term Diet.,"Since high-density lipoprotein (HDL) glycoprofiles are associated with HDL functional capacity, we set out to determine whether diet can alter the glycoprofiles of key HDL-associated proteins, including ApoE, a potent driver of chronic disease risk. Ten healthy subjects consumed a fast food (FF) and a Mediterranean (Med) diet for 4 days in randomized order, with a 4-day wash-out between treatments. A multiple reaction monitoring method was used to characterize the site-specific glycoprofiles of HDL proteins, and HDL functional capacity was analyzed. We describe for the first time that ApoE has 7 mucin-type O-glycosylation sites, which were not affected by short-term diet. The glycoprofiles of other HDL-associated proteins were also unaffected, except that a disialylated ApoC-III glycan was enriched after Med diet, and a nonsialylated ApoC-III glycan was enriched after FF diet. Twenty-five individual glycopeptides were significantly correlated with cholesterol efflux capacity and 21 glycopeptides were correlated with immunomodulatory capacity. Results from this study indicate that the glycoprofiles of HDL-associated proteins including ApoE are correlated with HDL functional capacity but generally unaffected by diet in the short term, except ApoC-III sialylation. These results suggest that HDL protein glycoprofiles are affected by both acute and long-term factors and may be useful for biomarker discovery.",2019,Twenty-five individual glycopeptides were significantly correlated with cholesterol efflux capacity and 21 glycopeptides were correlated with immunomodulatory capacity.,['Ten healthy subjects'],['fast food (FF) and a Mediterranean (Med) diet'],"['HDL functional capacity', 'cholesterol efflux capacity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",10.0,0.0122588,Twenty-five individual glycopeptides were significantly correlated with cholesterol efflux capacity and 21 glycopeptides were correlated with immunomodulatory capacity.,"[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Qiongyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beals', 'Affiliation': ''}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Rhodes', 'Affiliation': ''}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': ''}, {'ForeName': 'Carlito B', 'Initials': 'CB', 'LastName': 'Lebrilla', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': ''}]",Journal of proteome research,['10.1021/acs.jproteome.9b00450']
262,30952505,"Snack selection influences glucose metabolism, antioxidant capacity and cholesterol in healthy overweight adults: A randomized parallel arm trial.","Including carbohydrate/fructose-rich foods (predominantly fruit) in the diets of overweight individuals can improve chronic disease risk factors. We hypothesized dried plums (DP) would improve nutrient consumption, total antioxidant capacity (TAC), lipid and adipokine profiles, and would decrease adiposity and inflammation. To test this, we studied the effects of 8-weeks of twice-daily snacking of macronutrient-matched 100kcal servings of DP or refined carbohydrate-rich snack (low-fat muffins: LFM) on daily energy and nutrient consumption, and chronic disease risk factors in overweight adults. Body weight/composition, waist circumference, blood pressure, plasma glucose, insulin, c-peptide, lipids, TAC, adipokines and inflammation were measured at baseline and throughout the study. Postprandial glucose and insulin were assessed following assigned test foods at baseline and 8-weeks. Repeated measures ANOVAs were undertaken to examine group and time differences. Post-hoc independent and paired samples t-tests were conducted where necessary. DP increased (P<.05) overall intake of dietary fiber and potassium, and TAC, from baseline to 8-weeks. Baseline postprandial glycemia tended (P=.09) to be lower with DP versus LFM, while both groups had a decreased response after 8-weeks. Postprandial insulinemia was lower (P<.05) for DP at both time-points. No differences in body weight/composition, blood pressure, or fasting glucose, insulin, triglycerides, total cholesterol, HDL-C, inflammation or adipokines were detected. Low-density lipoprotein cholesterol (LDL-C) increased (P<.05) throughout the trial following LFM. Overall, DP lessened postprandial insulinemia, improved nutrient consumption and plasma TAC, and maintained plasma LDL-C compared to a macronutrient-matched refined carbohydrate snack, which could decrease chronic disease risk.",2019,Low-density lipoprotein cholesterol (LDL-C) increased (P<.05) throughout the trial following LFM.,"['overweight adults', 'healthy overweight adults']","['8-weeks of twice-daily snacking of macronutrient-matched 100kcal servings of DP or refined carbohydrate-rich snack (low-fat muffins: LFM', 'carbohydrate/fructose-rich foods (predominantly fruit', 'dried plums (DP']","['Postprandial glucose and insulin', 'Baseline postprandial glycemia', 'nutrient consumption, total antioxidant capacity (TAC), lipid and adipokine profiles', 'Body weight/composition, waist circumference, blood pressure, plasma glucose, insulin, c-peptide, lipids, TAC, adipokines and inflammation', 'Overall, DP lessened postprandial insulinemia, improved nutrient consumption and plasma TAC, and maintained plasma LDL-C', 'DP increased (P<.05) overall intake of dietary fiber and potassium, and TAC', 'Postprandial insulinemia', 'Low-density lipoprotein cholesterol (LDL-C', 'glucose metabolism, antioxidant capacity and cholesterol', 'daily energy and nutrient consumption, and chronic disease risk factors', 'body weight/composition, blood pressure, or fasting glucose, insulin, triglycerides, total cholesterol, HDL-C, inflammation or adipokines', 'chronic disease risk']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0175898', 'cui_str': 'Refined carbohydrate (substance)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0452660', 'cui_str': 'Muffin (substance)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0453861', 'cui_str': 'Rich food (substance)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0936040', 'cui_str': 'Plum'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0417921,Low-density lipoprotein cholesterol (LDL-C) increased (P<.05) throughout the trial following LFM.,"[{'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Clayton', 'Affiliation': 'San Diego State University, Department of Exercise and Nutritional Sciences, 5500 Campanile Drive, San Diego, CA 92182. Electronic address: Zachary.Clayton@Colorado.EDU.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fusco', 'Affiliation': 'San Diego State University, Department of Exercise and Nutritional Sciences, 5500 Campanile Drive, San Diego, CA 92182. Electronic address: Liz.Fusco@usrowing.org.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Schreiber', 'Affiliation': 'San Diego State University, Department of Exercise and Nutritional Sciences, 5500 Campanile Drive, San Diego, CA 92182. Electronic address: Schreiber.lisa@scrippshealth.org.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Carpenter', 'Affiliation': 'San Diego State University, Department of Exercise and Nutritional Sciences, 5500 Campanile Drive, San Diego, CA 92182. Electronic address: Jennifer.n.carpenter13.mil@mail.mil.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Hooshmand', 'Affiliation': 'San Diego State University, Department of Exercise and Nutritional Sciences, 5500 Campanile Drive, San Diego, CA 92182. Electronic address: shooshmand@mail.sdsu.edu.'}, {'ForeName': 'Mee Young', 'Initials': 'MY', 'LastName': 'Hong', 'Affiliation': 'San Diego State University, Department of Exercise and Nutritional Sciences, 5500 Campanile Drive, San Diego, CA 92182. Electronic address: mhong2@mail.sdsu.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'San Diego State University, Department of Exercise and Nutritional Sciences, 5500 Campanile Drive, San Diego, CA 92182. Electronic address: kern@mail.sdsu.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.03.002']
263,32273219,Measuring Self-Efficacy and Attitudes for Providing Mouth Care in Nursing Homes.,"OBJECTIVES


Mouth care is increasingly recognized as an important component of care in nursing homes (NHs), yet is known to be deficient. To promote quality improvement and inform research efforts, it is necessary to have valid measures of staff self-efficacy and attitudes to provide mouth care.
DESIGN


A self-administered questionnaire completed by NH staff, information about the NH obtained from the administrator, and oral hygiene assessments of NH residents.
SETTING AND PARTICIPANTS


A total of 434 staff in 14 NHs in North Carolina who were participating in a cluster randomized pragmatic trial of Mouth Care Without a Battle (MCWB).
METHODS


Staff in MCWB homes completed the questionnaire at baseline; staff in control homes completed it at 2-year follow-up. The 35-item questionnaire used new items and those from previous measures, many of which were modified for the NH setting. Factorial, construct, and criterion validity were assessed.
RESULTS


Exploratory factor analysis identified a 3-factor 11-item self-efficacy scale (promoting oral hygiene, providing mouth care, obtaining cooperation) named ""Self-Efficacy for Providing Mouth Care"" (SE-PMC), and a 2-factor 11-item attitudes scale (care of residents' teeth, care of own teeth), named Attitudes for Providing Mouth Care (A-PMC). Scores varied significantly across NHs and differentiated them based on profit status, age, and, for the A-PMC, NH size. Scores also differentiated among staff based on age and, for the SE-PMC, years of experience. In NHs where staff scored more highly, residents featured better oral hygiene (P < .001).
CONCLUSIONS AND IMPLICATIONS


The SE-PMC and A-PMC are valid, parsimonious, and useful measures for quality improvement and research to improve mouth care in NHs that can be used jointly or individually. Preliminary evidence suggests that these scales may be associated with resident-level plaque and gingival hygiene, making them useful tools to assess promotion of mouth care.",2020,"The SE-PMC and A-PMC are valid, parsimonious, and useful measures for quality improvement and research to improve mouth care in NHs that can be used jointly or individually.","['A total of 434 staff in 14 NHs in North Carolina who were participating in a cluster randomized pragmatic trial of', 'Staff in MCWB homes completed the questionnaire at baseline; staff in control homes completed it at 2-year follow-up', 'Nursing Homes']",['Mouth Care Without a Battle (MCWB'],"['oral hygiene', '3-factor 11-item self-efficacy scale (promoting oral hygiene, providing mouth care, obtaining cooperation) named ""Self-Efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1272386', 'cui_str': 'Mouth care management'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027365', 'cui_str': 'Name'}]",,0.0344397,"The SE-PMC and A-PMC are valid, parsimonious, and useful measures for quality improvement and research to improve mouth care in NHs that can be used jointly or individually.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC; School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: wretman@email.unc.edu.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC; School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, NC; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC; Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.02.007']
264,31991135,Aortic Insufficiency After Left Ventricular Assist Device Implantation: Predictors and Outcomes.,"BACKGROUND


The aim of this study was to evaluate the incidence, risk factors, and clinical impact of progression of aortic insufficiency (AI) after left ventricular assist device (LVAD) implantation.
METHODS


Patients undergoing primary durable LVAD implantation between 2004 and 2018 were included. Significant AI was defined as more than mild AI. Clinical and echocardiographic data were collected. Patients were stratified by degree of pre-LVAD AI into 3 groups: no AI, group I; trace AI, group II; and mild AI, group III.
RESULTS


Three hundred sixteen eligible patients underwent LVAD implant, 229 patients (72.5%) in group I, 54 (17.1%) in group II, and 33 (10.4%) in group III. Median follow-up was 469 days. Forty-two patients (13.3%) progressed to significant AI during follow-up. Group III patients had the highest rate of developing significant AI (I, 10.0%; II, 13.0%; III, 36.4%; P = .002). Freedom from significant AI at 1 year after LVAD implant was 94.5% in group I, 86.1% in group II, and 62.4% in group III (P < .001). Predictors of developing significant AI included mild preoperative AI, ischemic cardiomyopathy, and shorter duration of LVAD support. Patients with significant AI after LVAD implantation had higher mortality compared with those without (59.5% vs 37.2%; P = .006).
CONCLUSIONS


Although some patients supported with an LVAD develop significant AI, this risk is increased in those with mild AI preoperatively. This finding, in conjunction with the increased mortality risk once significant AI develops, suggests that closer follow-up and management of LVAD patients with mild preoperative AI may be prudent.",2020,"Patients with significant AI after LVAD had higher mortality compared to those without (59.5% vs 37.2%; p=0.006).
","['Patients undergoing primary durable LVAD implantation between 2004-2018 were included', '316 eligible patients underwent LVAD implant, including 229 (72.5%) patients in group']","['left ventricular assist device (LVAD) implantation', 'Left Ventricular Assist Device Implantation']","['higher mortality', 'Aortic Insufficiency', 'highest rate of developing significant AI', 'mild preoperative AI, ischemic cardiomyopathy, and shorter duration of LVAD support']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0003504', 'cui_str': 'Aortic Incompetence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",316.0,0.0272134,"Patients with significant AI after LVAD had higher mortality compared to those without (59.5% vs 37.2%; p=0.006).
","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kagawa', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Aranda-Michel', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Kormos', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Keebler', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Yisi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mathier', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: kilica2@upmc.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.12.030']
265,32096852,Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.,"Importance


Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
Objective


To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Design, Setting, and Participants


Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
Exposures


All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
Main Outcomes and Measures


The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Results


Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Conclusions and Relevance


Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT02933489.",2020,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","['Women With Dense Breasts Undergoing Screening', 'women with dense breasts', '17 women with invasive cancer and 2 of 6 women with DCIS', '1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis', 'Breast Cancer Detection', 'Participants\n\n\nCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening', '17 women with invasive cancer and 5 of 6 women with DCIS']","['abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT', 'Abbreviated Breast MRI vs Digital Breast Tomosynthesis']","['additional imaging recommendation rate', 'PPV', 'No interval cancers', 'sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS', 'invasive cancer detection rate', 'rate of invasive breast cancer detection', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1516.0,0.363375,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Comstock', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Newstead', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Bergin', 'Affiliation': 'UW Cancer Center at ProHealth Care, Waukesha, Wisconsin.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Rahbar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Sung', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'West Michigan Cancer Center, Kalamazoo.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Harvey', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Nicholson', 'Affiliation': 'Community Hospital, Munster, Indiana.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Ward', 'Affiliation': 'Rhode Island Hospital, Providence.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prather', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Schnall', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christiane K', 'Initials': 'CK', 'LastName': 'Kuhl', 'Affiliation': 'University Hospital of RWTH Aachen, Aachen, Germany.'}]",JAMA,['10.1001/jama.2020.0572']
266,31685429,Efficacy of exercise therapy during radiotherapy to prevent reduction in mouth opening in patients with head and neck cancer: A randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the efficacy of 2 protocols of exercise therapy to avoid reduction in mouth opening (MO) in patients undergoing radiotherapy for head and neck cancer.
STUDY DESIGN


This was a randomized, controlled, double-blind, 3-arm, parallel-group, prevention clinical trial. Ninety patients were randomized into 3 groups to perform exercises during radiotherapy treatment: intervention group 1 (G1); intervention group 2 (G2); and control group (CG). Maximum MO was measured before (T0), immediately after (T1), and at 12 months (T2) after completion of radiotherapy treatment. Generalized estimating equations model complemented by the least significant difference test was applied to group comparisons.
RESULTS


There was no significant difference in MO measure between the groups at the 3 assessment time points (P = .264). The difference in MO measure from baseline to 12 months after having completed radiotherapy was -1 mm in CG (95% confidence interval [CI] -4.0 to 2.0); 1.3 mm in G1 (95% CI -1.7 to 4.3); and 0.5 mm in G2 (95% CI -3.4 to 4.4).
CONCLUSIONS


It was not possible to conclude that the exercise protocols performed in this study are more effective than the usual guidance to prevent reduction in MO in patients undergoing radiotherapy for head and neck cancer.",2020,There was no significant difference in MO measure between the groups at the 3 assessment time points (P = .264).,"['patients with head and neck cancer', 'Ninety patients', 'patients undergoing radiotherapy for head and neck cancer']","['radiotherapy', 'exercise therapy', 'exercises during radiotherapy treatment: intervention group 1 (G1); intervention group 2 (G2); and control group (CG']","['MO measure', 'Maximum MO']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",90.0,0.221379,There was no significant difference in MO measure between the groups at the 3 assessment time points (P = .264).,"[{'ForeName': 'Karoline Camargo', 'Initials': 'KC', 'LastName': 'Bragante', 'Affiliation': 'Department of Health Science, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: karoline.bragante@gmail.com.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Groisman', 'Affiliation': 'Department of Health Science, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'Carboni', 'Affiliation': 'Department of Rehabilitation, UFCSPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jaqueline Munaretto Timm', 'Initials': 'JMT', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Skin Care, Fundação Antônio Prudente, São Paulo, SP, Brazil.'}, {'ForeName': 'Neiro Waechter', 'Initials': 'NW', 'LastName': 'da Motta', 'Affiliation': 'Department of Radiation Oncology, Hospital Santa Rita, Santa Casa de Misericórdia de Porto Alegre (ISCMPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Department of Rehabilitation, UFCSPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Roselie Corcini', 'Initials': 'RC', 'LastName': 'Pinto', 'Affiliation': 'Department of Radiation Oncology, Hospital Santa Rita, Santa Casa de Misericórdia de Porto Alegre (ISCMPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo Della Mea', 'Initials': 'RDM', 'LastName': 'Plentz', 'Affiliation': 'Department of Health Science, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Wienandts', 'Affiliation': 'Department of Special Dental Care, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Geraldo Pereira', 'Initials': 'GP', 'LastName': 'Jotz', 'Affiliation': 'Department of Morphological Sciences, UFRGS, Rua Sarmento Leite, Porto Alegre, RS, Brazil.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2019.09.011']
267,32274576,The prevention of musculoskeletal complaints: long-term effect of a work-related psychosocial coaching intervention compared to physiotherapy alone-a randomized controlled trial.,"PURPOSE


Research shows that psychosocial factors play a significant role in the emergence of musculoskeletal complaints (MSC). The aim of this study was to determine the long-term effects on unspecific MSC by a combined physiotherapy and coaching intervention compared to physiotherapy alone. The coaching intervention focussed on enabling better strategies for coping with work stressors.
METHODS


The participants of a previous randomized controlled intervention were invited to participate again in a third follow-up survey 22 months after the end of the intervention. In 2014, 65 nurses completed a 10-week personalised physiotherapy. Additionally, the intervention group (n = 33) passed five individual coaching sessions, plus an opening and closing session. 44 nurses (IG: n = 24; CG: n = 20) passed again a physical examination as well as another questionnaire assessment in 2016. The primary outcome was MSC, secondary outcomes were work ability and work-related well-being. Due to missing data, multiple imputations were conducted using the mice package in R. Data were analysed by ANOVA with two-way repeated measures, t tests for independent samples and Chi-squared tests.
RESULTS


In respect of MSC, stronger improvement of movement in the vertebral column was observed in the IG compared to the CG. No differences between the IG and CG regarding other long-term effects were observed.
CONCLUSIONS


The results suggest that the combined intervention of work-related coaching and physiotherapy had only a marginally stronger long-term effect with respect to MSC than physiotherapy alone.",2020,"No differences between the IG and CG regarding other long-term effects were observed.
","['In 2014, 65 nurses completed a 10-week', '44 nurses (IG: n\u2009=\u200924']","['work-related psychosocial coaching intervention', 'combined physiotherapy and coaching intervention', 'individual coaching sessions, plus an opening and closing session', 'CG: n\u2009=\u200920) passed again a physical examination as well as another questionnaire assessment', 'coaching intervention', 'physiotherapy alone', 'personalised physiotherapy']",['work ability and work-related well-being'],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0532922,"No differences between the IG and CG regarding other long-term effects were observed.
","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Becker', 'Affiliation': 'Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Angerer', 'Affiliation': 'Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Institute of Psychology, Work and Organizational Psychology, University of Duisburg-Essen, Essen, Germany. andreas_mueller@uni-due.de.'}]",International archives of occupational and environmental health,['10.1007/s00420-020-01538-1']
268,32259016,Diabetes and Clinical Outcome in Patients With Metastatic Colorectal Cancer: CALGB 80405 (Alliance).,"Background


Diabetes is a prognostic factor for some malignancies, but its association with outcome in patients with advanced or metastatic colorectal cancer (CRC) is less clear.
Methods


This cohort study was nested within a randomized trial of first-line chemotherapy and bevacizumab and/or cetuximab for advanced or metastatic CRC. Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network. The primary exposure was physician-documented diabetes at the time of enrollment. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events. Tests of statistical significance were two-sided.
Results


Among 2326 patients, 378 (16.3%) had diabetes. The median follow-up time was 6.0 years. We observed 1973 OS events and 2173 PFS events. The median time to an OS event was 22.7 months among those with diabetes and 27.1 months among those without diabetes (HR = 1.27, 95% CI = 1.13 to 1.44;  P  <   .001). The median time to a PFS event was 9.7 months among those with diabetes and 10.8 months among those without diabetes (HR = 1.16, 95% CI = 1.03 to 1.30;  P  =   .02). Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
Conclusions


Diabetes is associated with an increased risk of mortality and tumor progression in patients with advanced or metastatic CRC. Patients with diabetes tolerate first-line treatment with chemotherapy and monoclonal antibodies similarly to patients without diabetes.",2020,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","['Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network', 'Patients with diabetes tolerate first-line treatment with', 'patients with advanced or metastatic colorectal cancer (CRC', 'advanced or metastatic CRC', 'Patients', '2326 patients, 378 (16.3%) had diabetes', 'patients with advanced or metastatic CRC']","['bevacizumab and/or cetuximab', 'chemotherapy and monoclonal antibodies']","['physician-documented diabetes', 'overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events', 'median time to a PFS event', 'median time to an OS event', 'grade 3 hypertension', 'adverse events, including neuropathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",2326.0,0.0321453,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Blase N', 'Initials': 'BN', 'LastName': 'Polite', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Denlinger', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}]",JNCI cancer spectrum,['10.1093/jncics/pkz078']
269,32101302,Effect of a Skin Self-monitoring Smartphone Application on Time to Physician Consultation Among Patients With Possible Melanoma: A Phase 2 Randomized Clinical Trial.,"Importance


Melanoma is among the most lethal skin cancers; it has become the fifth most common cancer in the United Kingdom, and incidence rates are rising. Population approaches to reducing incidence have focused on mass media campaigns to promote earlier presentation and potentially improve melanoma outcomes; however, interventions using smartphone applications targeting those with the greatest risk could promote earlier presentation to health care professionals for individuals with new or changing skin lesions.
Objective


To study the effect of a commercially available skin self-monitoring (SSM) smartphone application among individuals with increased risk of melanoma on their decision to seek help for changing skin lesions.
Design, Setting, and Participants


This phase 2 randomized clinical trial was conducted in 12 family practices in Eastern England between 2016 and 2017. A total of 238 participants, aged 18 to 75 years and with an increased risk of melanoma, were identified using a real-time melanoma risk assessment tool in family practice waiting rooms. Analysis was intention to treat. Participants were observed for 12 months, and data analysis was conducted from January to August 2018.
Intervention


The intervention and control groups received a consultation with standard written advice on sun protection and skin cancer detection. The intervention group had an SSM application loaded on their smartphone and received instructions for use and monthly self-monitoring reminders.
Main Outcomes and Measures


The coprimary outcomes were skin consultation rates with family practice physicians and patient intervals, measured as the time between noticing a skin change and consulting with a family practice clinician. Follow-up questionnaires were sent at 6 and 12 months, and consultation rates were extracted from family practice records. Secondary outcomes included skin self-examination benefits and barriers, self-efficacy for consulting without delay, perceived melanoma risk, sun protection habits, and potential harms.
Results


A total of 238 patients were randomized (median [interquartile range] age, 55 [43-65] years, 131 [55.0%] women, 227 [95.4%] white British; 119 [50.0%] randomized to the intervention group). Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire. There were no significant differences in skin consultation rates (adjusted risk ratio, 0.96; 95% CI, 0.56 to 1.66; P = .89), measures of SSM (adjusted mean difference, 0.08; 95% CI, -0.83 to 1.00; P = .86), or psychological harm (eg, Melanoma Worry Scale: adjusted mean difference, -0.12; 95% CI, -0.56 to 0.31; P = .58).
Conclusions and Relevance


In this study, recruitment, retention, and initial delivery of the intervention were feasible, and this research provided no evidence of harm from the SSM smartphone application. However, no evidence of benefit on skin self-examination or health care consulting was found, and there is no reason at this stage to recommend its implementation in this population at increased risk of melanoma.
Trial Registration


isrctn.org Identifier: ISRCTN16061621.",2020,"Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire.","['238 participants, aged 18 to 75 years and with an increased risk of melanoma, were identified using a real-time melanoma risk assessment tool in family practice waiting rooms', 'Patients With Possible Melanoma', 'individuals with new or changing skin lesions', 'individuals with increased risk of melanoma', '238 patients were randomized (median [interquartile range] age, 55 [43-65] years, 131 [55.0%] women, 227 [95.4%] white British; 119 [50.0', '12 family practices in Eastern England between 2016 and 2017']","['Skin Self-monitoring Smartphone Application', 'consultation with standard written advice on sun protection and skin cancer detection', 'SSM application loaded on their smartphone and received instructions for use and monthly self-monitoring reminders', 'commercially available skin self-monitoring (SSM) smartphone application']","['skin consultation rates with family practice physicians and patient intervals, measured as the time between noticing a skin change and consulting with a family practice clinician', 'skin consultation rates', 'consultations regarding skin changes', 'Time to Physician Consultation', 'skin self-examination benefits and barriers, self-efficacy for consulting without delay, perceived melanoma risk, sun protection habits, and potential harms', 'measures of SSM']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1278523', 'cui_str': 'White British'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",238.0,0.143568,"Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire.","[{'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Walter', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'Pannebakker', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Barclay', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Saunders', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murchie', 'Affiliation': 'Institute of Applied Health Science, Centre of Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Burrows', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Emery', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0001']
270,32101308,Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial.,"Importance


Dementia is often underdiagnosed in nursing homes (NHs). This potentially results in inappropriate care, and high rates of emergency department (ED) transfers in particular.
Objective


To assess whether systematic dementia screening of NH residents combined with multidisciplinary team meetings resulted in a lower rate of ED transfer at 12 months compared with usual care.
Design, Setting, and Participants


Multicenter, cluster randomized trial with NHs as the unit of randomization. The IDEM (Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units) trial took place at 64 public and private NHs in France. Recruitment started on May 1, 2010, and was completed on March 31, 2012. Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included. The residents were followed up for 18 months. The main study analyses were completed on October 14, 2016.
Intervention


Two parallel groups were compared: an intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice. During the inclusion period of 23 months, all residents of participating NHs who met eligibility criteria were included in the study.
Main Outcomes and Measures


The primary end point (ED transfer) was analyzed at 12 months, but the residents included were followed up for 18 months.
Results


A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs). The final study visit was completed by 1042 residents (73.0%). The main reason for early discontinuation was death (318 residents [22.7%]). The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
Conclusions and Relevance


This study failed to demonstrate that systematic screening for dementia in NHs resulted in fewer ED transfers. The findings do not support implementation of multidisciplinary team meetings for systematic dementia screening of all NH residents, beyond the national recommendations for dementia diagnosis, to reduce ED transfers.
Trial Registration


ClinicalTrials.gov Identifier: NCT01569997.",2020,"The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
","['1042 residents (73.0', 'Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included', 'A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs', '64 public and private NHs in France', 'Nursing Homes for Reducing Emergency Department Transfers', 'all residents of participating NHs who met eligibility criteria were included in the study']","['NH residents combined with multidisciplinary team meetings', 'intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice']","['rate of ED transfer', 'risk of ED transfers']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0741453', 'cui_str': 'Bedridden'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",64.0,0.119132,"The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Tavassoli', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Laffon de Mazières', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rapp', 'Affiliation': 'LIRAES (EA 4470) & Chaire AGEINOMIX, Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hermabessière', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Tournay', 'Affiliation': 'Unité de Soutien Méthodologique à la Recherche, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0049']
271,32274986,"Use, Acceptability, Performance, and Health Impact of Hollow Fiber Ultrafilters for Water Treatment in Rural Kenyan Households, 2009-2011.","Diarrheal illness remains a leading cause of morbidity and mortality in children < 5 years in developing countries, and contaminated water contributes to diarrhea risk. To address this problem, a novel hollow fiber ultrafilter (HFU) was developed for household water treatment. To test its impact on water quality and infant health, we conducted a cluster-randomized longitudinal evaluation in 10 intervention and 10 comparison villages in Kenya, attempting to enroll all households with infants (< 12 months old). We conducted a baseline survey, distributed HFUs to intervention households, made biweekly home visits for 1 year to assess water treatment practices and diarrhea in infants, and tested water samples from both groups every 2 months for  Escherichia coli . We enrolled 92 infants from intervention households and 74 from comparison households. During the 1-year study period, 45.7% of intervention households and 97.3% of comparison households had at least one stored water sample test positive for  E. coli . Compared with comparison households, the odds of  E. coli  contamination in stored water was lower for intervention households (odds ratio [OR]: 0.42, 95% CI: 0.24, 0.74), but there was no difference in the odds of reported diarrhea in infants, adjusting for covariates (OR: 1.19, 95% CI: 0.74, 1.90). Although nearly all water samples obtained from unprotected sources and filtered by the HFU were free of  E. coli  contamination, HFUs alone were not effective at reducing diarrhea in infants.",2020,"Compared with comparison households, the odds of  E. coli  contamination in stored water was lower for intervention households (OR: 0.42, 95% CI: 0.24, 0.74), but there was no difference in the odds of reported diarrhea in infants, adjusting for covariates (OR: 1.19, 95% CI: 0.74, 1.90).","['92 infants from intervention households and 74 from comparison households', 'children < 5 years in developing countries', '10 intervention and 10 comparison villages in Kenya, attempting to enroll all households with infants (< 12 months old', 'Rural Kenyan Households, 2009-2011']",[],"['Use, Acceptability, Performance, and Health Impact of Hollow Fiber Ultrafilters', 'diarrhea', 'water quality and infant health']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}]",[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332484', 'cui_str': 'Hollow shape'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}]",92.0,0.0801791,"Compared with comparison households, the odds of  E. coli  contamination in stored water was lower for intervention households (OR: 0.42, 95% CI: 0.24, 0.74), but there was no difference in the odds of reported diarrhea in infants, adjusting for covariates (OR: 1.19, 95% CI: 0.74, 1.90).","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fagerli', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gieraltowski', 'Affiliation': 'Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Nygren', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Foote', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gaines', 'Affiliation': 'Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Oremo', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Aloyce', 'Initials': 'A', 'LastName': 'Odhiambo', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Sunkyung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Quick', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0862']
272,32267601,A reduced healing protocol for sinus floor elevation in a staged approach with deproteinized bovine bone mineral alone: A randomized controlled clinical trial of a 5-month healing in comparison to the 8-month healing.,"PURPOSE


To investigate the feasibility of reducing the healing time of maxillary sinus floor elevation (MSFE) by a two-stage approach using deproteinized bovine bone mineral (DBBM) alone, based on clinical, histomorphometric, and microradiographic evaluations.
MATERIALS AND METHODS


Twenty consecutive cases with an atrophic posterior edentulous maxilla were randomly assigned to two groups at a ratio of 1:1. The lateral window approach to MSFE with DBBM alone was followed by an 8-month bone-healing period in the control group compared to 5 months in the test group. During implant placement, bone biopsies were harvested from implant osteotomy sites for micro-computed tomography (CT), histological, and histomorphometric evaluations. Cone beam CT (CBCT) scans were performed before and immediately after MSFE and after the bone-healing periods. The implant stability quotient (ISQ) was measured sequentially at implant placement and 1, 3, and 6 months thereafter.
RESULTS


The histomorphometric and microradiographic results showed no significant differences in new bone formation on the augmented sinus floor between the two groups (all Ps > .05), except that trabecular thickness was significantly reduced and trabecular separation significantly increased in the test group (both Ps < .05). The ISQs of both groups increased continuously after implant placement, but the difference was not significant between the groups at each time point. CBCT analyses showed that the extent of volumetric loss was comparable after bone healing for 5 and 8 months (P > .05).
CONCLUSIONS


Within the limitations of this study, the bone-healing time of MSFE with DBBM alone for staged implant placement could be reduced to 5 months instead of 8 or 9 months, based on the histomorphometric, microradiographic, and clinical outcomes; however, impact on long-term implant survival remains unknown and needs further investigation with long-term follow-ups.",2020,"The histomorphometric and microradiographic results showed no significant differences in new bone formation on the augmented sinus floor between the two groups (all Ps > .05), except that trabecular thickness was significantly reduced and trabecular separation significantly increased in the test group (both Ps < .05).",['Twenty consecutive cases with an atrophic posterior edentulous maxilla'],"['deproteinized bovine bone mineral (DBBM', 'deproteinized bovine bone mineral alone', 'Cone beam CT (CBCT) scans']","['trabecular thickness', 'trabecular separation', 'implant stability quotient (ISQ', 'volumetric loss', 'new bone formation', 'healing time of maxillary sinus floor elevation (MSFE']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",20.0,0.0236259,"The histomorphometric and microradiographic results showed no significant differences in new bone formation on the augmented sinus floor between the two groups (all Ps > .05), except that trabecular thickness was significantly reduced and trabecular separation significantly increased in the test group (both Ps < .05).","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Dehua', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}]",Clinical implant dentistry and related research,['10.1111/cid.12906']
273,32250572,Effectiveness of an oral care tablet containing kiwifruit powder in reducing oral bacteria in tongue coating: A crossover trial.,"OBJECTIVES


The aim of this study was to investigate the effect of an oral care tablet containing kiwifruit powder on oral bacteria in tongue coating compared with tongue brushing.
MATERIAL AND METHODS


Thirty-two healthy, young adults were enrolled, and a crossover clinical trial was conducted. The volatile sulfur compound (VSC) concentration, Winkel tongue-coating index (WTCI), and the number of total bacteria in addition to Fusobacterium nucleatum in tongue coating were measured. We instructed subjects to remove tongue coating by tongue brush for Intervention I, to keep the oral care tablet containing kiwifruit powder on the tongue dorsum and to let it dissolve naturally for Intervention II, and three oral care tablets 1 day before the measurement for Intervention III.
RESULTS


There were significant differences in terms of the level of H 2  S, VSC, and WTCI at Intervention I and all evaluation values at Intervention II. There were significant differences in terms of the level of H 2  S, VSC, WTCI, the number of total bacteria, and F. nucleatum at Intervention III. The value of WTCI, the number of bacteria, and F. nucleatum decreased significantly after taking the oral care tablets than after tongue brushing. When compared with Interventions I and III, Intervention III showed the effective results; there were significant differences in the number of total bacteria and F. nucleatum between tongue brushing and taking tablets.
CONCLUSIONS


These results suggested that the oral care tablet containing kiwifruit powder could be effective in reducing total bacteria and F. nucleatum in tongue coating when compared with tongue brushing.",2020,"The value of WTCI, the number of bacteria, and F. nucleatum decreased significantly after taking the oral care tablets than after tongue brushing.","['tongue coating', 'Thirty-two healthy, young adults']",['oral care tablet containing kiwifruit powder'],"['oral bacteria', 'value of WTCI, the number of bacteria, and F. nucleatum', 'level of H 2  S, VSC, and WTCI at Intervention', 'level of H 2  S, VSC, WTCI, the number of total bacteria, and F. nucleatum', 'number of total bacteria and F. nucleatum', 'total bacteria and F. nucleatum', 'volatile sulfur compound (VSC) concentration, Winkel tongue-coating index (WTCI']","[{'cui': 'C0009144', 'cui_str': 'Furred tongue'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0038776', 'cui_str': 'Sulfur compound'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009144', 'cui_str': 'Furred tongue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",32.0,0.0263385,"The value of WTCI, the number of bacteria, and F. nucleatum decreased significantly after taking the oral care tablets than after tongue brushing.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hygiene and Oral Health Science, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Hinode', 'Affiliation': 'Department of Hygiene and Oral Health Science, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Department of Hygiene and Oral Health Science, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Yoshioka', 'Affiliation': 'Faculty of Health and Welfare, Tokushima Bunri University, Tokushima, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Asakuma', 'Affiliation': 'Institute of Health Sciences, Ezaki Glico Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takii', 'Affiliation': 'Institute of Health Sciences, Ezaki Glico Co., Ltd., Osaka, Japan.'}]",Clinical and experimental dental research,['10.1002/cre2.262']
274,31095313,"Whey Protein Hydrolysate Increases Amino Acid Uptake, mTORC1 Signaling, and Protein Synthesis in Skeletal Muscle of Healthy Young Men in a Randomized Crossover Trial.","BACKGROUND


Muscle protein synthesis (MPS) can be stimulated by ingestion of protein sources, such as whey, casein, or soy. Protein supplementation can enhance muscle protein synthesis after exercise and may preserve skeletal muscle mass and function in aging adults. Therefore, identifying protein sources with higher anabolic potency is of high significance.
OBJECTIVE


The aim of this study was to determine the anabolic potency and efficacy of a novel whey protein hydrolysate mixture (WPH) on mechanistic target of rapamycin complex 1 (mTORC1) signaling and skeletal MPS in healthy young subjects.
METHODS


Ten young men (aged 28.7 ± 3.6 y, 25.2 ± 2.9 kg/m2 body mass index [BMI]) were recruited into a double-blind two-way crossover trial. Subjects were randomized to receive either 0.08 g/kg of body weight (BW) of WPH or an intact whey protein (WHEY) mixture during stable isotope infusion experiments. Fractional synthetic rate, leucine and phenylalanine kinetics, and markers of amino acid sensing were assessed as primary outcomes before and 1-3 h after protein ingestion using a repeated measures mixed model.
RESULTS


Blood leucine concentration, delivery of leucine to muscle, transport of leucine from blood into muscle and intracellular muscle leucine concentration significantly increased to a similar extent 1 h after ingestion of both mixtures (P < 0.05). Phosphorylation of S6K1 (i.e. a marker of mTORC1 activation) increased equally by ∼20% 1-h postingestion (P < 0.05). Ingestion of WPH and WHEY increased mixed MPS similarly in both groups by ∼43% (P < 0.05); however, phenylalanine utilization for synthesis increased in both treatments 1-h postingestion but remained elevated 3-h postingestion only in the WPH group (P < 0.05).
CONCLUSIONS


We conclude that a small dose of WPH effectively increases leucine transport into muscle, activating mTORC1 and stimulating MPS in young men. WPH anabolic potency and efficacy for promoting overall muscle protein anabolism is similar to WHEY, an intact protein source. This trial was registered at clinicaltrials.gov as NCT03313830.",2019,Phosphorylation of S6K1 (i.e. a marker of mTORC1 activation) increased equally by ∼20% 1-h postingestion (P < 0.05).,"['young men', 'Ten young men (aged 28.7 ± 3.6 y, 25.2 ± 2.9 kg/m2 body mass index [BMI', 'healthy young subjects', 'Healthy Young Men']","['Protein supplementation', 'Whey Protein Hydrolysate', 'WPH', 'novel whey protein hydrolysate mixture (WPH', 'WPH or an intact whey protein (WHEY) mixture during stable isotope infusion experiments']","['Ingestion of WPH and WHEY increased mixed MPS', 'Fractional synthetic rate, leucine and phenylalanine kinetics, and markers of amino acid sensing', 'Blood leucine concentration, delivery of leucine to muscle, transport of leucine from blood into muscle and intracellular muscle leucine concentration', 'leucine transport into muscle, activating mTORC1 and stimulating MPS', 'phenylalanine utilization for synthesis', 'anabolic potency and efficacy']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0452720', 'cui_str': 'Whey'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0042153', 'cui_str': 'use'}]",10.0,0.0658843,Phosphorylation of S6K1 (i.e. a marker of mTORC1 activation) increased equally by ∼20% 1-h postingestion (P < 0.05).,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Moro', 'Affiliation': 'Department of Nutrition & Metabolism.'}, {'ForeName': 'Camille R', 'Initials': 'CR', 'LastName': 'Brightwell', 'Affiliation': 'Department of Neuroscience, Cell Biology, and Anatomy.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Velarde', 'Affiliation': 'Department of Nutrition & Metabolism.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Fry', 'Affiliation': 'Department of Nutrition & Metabolism.'}, {'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Nakayama', 'Affiliation': 'Food Science & Technology Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Sanbongi', 'Affiliation': 'Food Science & Technology Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'Department of Internal Medicine/Geriatrics.'}, {'ForeName': 'Blake B', 'Initials': 'BB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Nutrition & Metabolism.'}]",The Journal of nutrition,['10.1093/jn/nxz053']
275,32251303,Dietary restriction for prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary angiography: a randomized controlled trial.,"Short-term dietary restriction (DR) may prevent organ damage from ischemic or toxic insults in animals, but clear evidence in humans is missing. While especially intraarterial administration of contrast media represents a cause of hospital-acquired acute kidney injury (AKI), targeted preventive strategies are not available. This trial investigated the feasibility and effectiveness of pre-interventional DR for preventing AKI in patients undergoing percutaneous coronary intervention (PCI). Patients were randomized to receive a formula diet containing 60% of daily energy requirement (DR group) or ad-libitum food during the 4-day-interval before PCI. Primary endpoint was change of serum creatinine 48 h after PCI (Δcreatinine). Further analyses included incidence of AKI and safety evaluation. Δcreatinine post PCI in the DR group vs. the control group did not show any difference (DR: 0.03(-0.15,0.14)mg/dL vs. control: 0.09(-0.03,0.22)mg/dL;p = 0.797). Subgroup analyses revealed a significant beneficial impact of DR in patients that received ≤100 ml of contrast agent (DR n = 26: Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n = 24: Δcreatinine 0.10(-0.08,0.24)mg/dL; p = 0.041) and in patients with ≤2 risk factors for AKI (DR: n = 27; Δcreatinine -0.01(-0.18,0.07)mg/dL vs. control n = 31: Δcreatinine 0.09(-0.03,0.16)mg/dl; p = 0.030). Although the primary endpoint was not met, the results of this trial suggest a beneficial impact of DR in low-to-moderate risk patients.",2020,"Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n = ","['patients that received ≤100', 'patients undergoing percutaneous coronary angiography', 'patients undergoing percutaneous coronary intervention (PCI']","['ml of contrast agent (DR n\u2009=\u200926', 'pre-interventional DR', 'formula diet containing 60% of daily energy requirement (DR group) or ad-libitum food', 'Δcreatinine 0.10(-0.08,0.24)mg/dL', 'dL vs. control', 'Dietary restriction', 'Short-term dietary restriction (DR', 'Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n\u2009']","['change of serum creatinine 48\u2009h after PCI (Δcreatinine', 'incidence of AKI and safety evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4517402', 'cui_str': '0.03'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.169756,"Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n = ","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Grundmann', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany. franziska.grundmann@uk-koeln.de.'}, {'ForeName': 'Roman-Ulrich', 'Initials': 'RU', 'LastName': 'Müller', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Karla Johanna Ruth', 'Initials': 'KJR', 'LastName': 'Hoyer-Allo', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Martin Richard', 'Initials': 'MR', 'LastName': 'Späth', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Passmann', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Becker', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Pfister', 'Affiliation': 'Department III of Internal Medicine, Heart Center, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'Department III of Internal Medicine, Heart Center, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benzing', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Burst', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}]",Scientific reports,['10.1038/s41598-020-61895-2']
276,32251360,Effects of daily L-dopa administration on learning and brain structure in older adults undergoing cognitive training: a randomised clinical trial.,"Cognitive aging creates major individual and societal burden, motivating search for treatment and preventive care strategies. Behavioural interventions can improve cognitive performance in older age, but effects are small. Basic research has implicated dopaminergic signalling in plasticity. We investigated whether supplementation with the dopamine-precursor L-dopa improves effects of cognitive training on performance. Sixty-three participants for this randomised, parallel-group, double-blind, placebo-controlled trial were recruited via newspaper advertisements. Inclusion criteria were: age of 65-75 years, Mini-Mental State Examination score >25, absence of serious medical conditions. Eligible subjects were randomly allocated to either receive 100/25 mg L-dopa/benserazide (n = 32) or placebo (n = 31) prior to each of twenty cognitive training sessions administered during a four-week period. Participants and staff were blinded to group assignment. Primary outcomes were latent variables of spatial and verbal fluid intelligence. Compared to the placebo group, subjects receiving L-dopa improved less in spatial intelligence (-0.267 SDs; 95%CI [-0.498, -0.036]; p = 0.024). Change in verbal intelligence did not significantly differ between the groups (-0.081 SDs, 95%CI [-0.242, 0.080]; p = 0.323). Subjects receiving L-dopa also progressed slower through the training and the groups displayed differential volumetric changes in the midbrain. No statistically significant differences were found for the secondary cognitive outcomes. Adverse events occurred for 10 (31%) and 7 (23%) participants in the active and control groups, correspondingly. The results speak against early pharmacological interventions in older healthy adults to improve broader cognitive functions by targeting the dopaminergic system and provide no support for learning-enhancing properties of L-dopa supplements in the healthy elderly. The findings warrant closer investigation about the cognitive effects of early dopamine-replacement therapy in neurological disorders. This trial was preregistered at the European Clinical Trial Registry, EudraCT#2016-000891-54 (2016-10-05).",2020,Subjects receiving L-dopa also progressed slower through the training and the groups displayed differential volumetric changes in the midbrain.,"['Inclusion criteria were: age of 65-75 years, Mini-Mental State Examination score >25, absence of serious medical conditions', 'Eligible subjects', 'older healthy adults', 'EudraCT#2016-000891-54 (2016-10-05', 'older adults undergoing cognitive training']","['placebo', 'daily L-dopa administration', 'dopamine-precursor L-dopa', 'dopamine-replacement therapy', 'Behavioural interventions', 'speak against early pharmacological interventions', 'cognitive training', 'receive 100/25 mg L-dopa/benserazide (n\u2009=\u200932) or placebo']","['Change in verbal intelligence', 'spatial intelligence', 'learning and brain structure', 'latent variables of spatial and verbal fluid intelligence', 'cognitive performance', 'Adverse events']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0005014', 'cui_str': 'Benserazide'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",63.0,0.433836,Subjects receiving L-dopa also progressed slower through the training and the groups displayed differential volumetric changes in the midbrain.,"[{'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Lebedev', 'Affiliation': 'Aging Research Center, Department of Neurobiology, Care sciences, and Society, Karolinska Institutet, Stockholm, Sweden. alexander.lebedev@ki.se.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Aging Research Center, Department of Neurobiology, Care sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'Aging Research Center, Department of Neurobiology, Care sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fredborg', 'Affiliation': 'Aging Research Center, Department of Neurobiology, Care sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Akenine', 'Affiliation': 'Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Hillilä', 'Affiliation': 'Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Andersen', 'Affiliation': 'Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Spulber', 'Affiliation': 'Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elizabeth C M', 'Initials': 'ECM', 'LastName': 'de Lange', 'Affiliation': 'Leiden Academic Centre for Drug Research, Division of Systems Biomedicine and Pharmacology, Universiteit Leiden, Leiden, Netherlands.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'van den Berg', 'Affiliation': 'Leiden Academic Centre for Drug Research, Division of Systems Biomedicine and Pharmacology, Universiteit Leiden, Leiden, Netherlands.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Aging Research Center, Department of Neurobiology, Care sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center, Department of Neurobiology, Care sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}]",Scientific reports,['10.1038/s41598-020-62172-y']
277,30790028,Modifiable elements of ICU supportive care and communication are associated with surrogates' PTSD symptoms.,"PURPOSE


To identify specific components of ICU clinician supportive care and communication that are associated with increased post-traumatic stress disorder (PTSD) symptoms for surrogate decision makers of patients with chronic critical illness (CCI).
METHODS


We conducted a secondary analysis of data from a randomized controlled trial of palliative care-led meetings to provide information and support for CCI surrogates. The primary outcome for this secondary analysis was PTSD symptoms at 90 days, measured by the Impact of Event Scale-Revised (IES-R). Caregiver perceptions of clinician support and communication were assessed using a version of the After-Death Bereaved Family Member Interview (ADBFMI) instrument modified for use in non-bereaved in addition to bereaved caregivers. The association between ADBFMI items and IES-R score was analyzed using multiple linear regression.
RESULTS


Ninety-day follow up was complete for 306 surrogates corresponding to 224 patients. Seventy-one percent of surrogates were female, and the mean age was 51 years. Of the domains, negative perception of the patient's physical comfort and emotional support was associated with the greatest increase in surrogate PTSD symptoms (beta coefficient 1.74, 95% CI 0.82-2.65). The three specific preselected items associated with increased surrogate PTSD symptoms were surrogate perception that clinicians did not listen to concerns (beta coefficient 10.7, 95% CI 3.6-17.9), failure of the physician to explain how the patient's pain would be treated (beta coefficient 12.1, 95% CI 4.9-19.3), and lack of sufficient religious contact (beta coefficient 11.7, 95% CI 2-21.3).
CONCLUSION


Modifiable deficits in ICU clinician support and communication were associated with increased PTSD symptoms among CCI surrogates.",2019,"Of the domains, negative perception of the patient's physical comfort and emotional support was associated with the greatest increase in surrogate PTSD symptoms (beta coefficient 1.74, 95% CI 0.82-2.65).","['patients with chronic critical illness (CCI', 'Seventy-one percent of surrogates\xa0were female, and the mean age was 51\xa0years']",[],"['PTSD symptoms at 90\xa0days, measured by the Impact of Event Scale-Revised (IES-R', 'ADBFMI items and IES-R score', 'PTSD symptoms', 'surrogate PTSD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0540937,"Of the domains, negative perception of the patient's physical comfort and emotional support was associated with the greatest increase in surrogate PTSD symptoms (beta coefficient 1.74, 95% CI 0.82-2.65).","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Wendlandt', 'Affiliation': 'University of North Carolina School of Medicine, 130 Mason Farm Road CB#7020, Chapel Hill, NC, 27599, USA. blair.wendlandt@unchealth.unc.edu.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Ceppe', 'Affiliation': 'University of North Carolina School of Medicine, 130 Mason Farm Road CB#7020, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'University of North Carolina School of Medicine, 130 Mason Farm Road CB#7020, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': 'University of North Carolina School of Medicine, 130 Mason Farm Road CB#7020, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Danis', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': ""Dana Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Nelson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill-Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Carson', 'Affiliation': 'University of North Carolina School of Medicine, 130 Mason Farm Road CB#7020, Chapel Hill, NC, 27599, USA.'}]",Intensive care medicine,['10.1007/s00134-019-05550-z']
278,32253894,"A multi-modal exercise intervention that improves cognitive function and physical performance, elderly with mobility-related disability: a randomized controlled trial.","BACKGROUND


Physical exercise interventions have showed improvement on cognitive performance and mobility of old people. However, the results regarding the inclusion of cognitive activities into exercise were not evaluated simultaneously. Therefore, the aim of this study was to investigate the effect of multimodal exercise program on cognitive function and physical performance in elderly people with mobility disabilities.
METHODS


The sample of the study consisted of 70 old people randomly appointed to the exercise and control groups (35 people for each) with mobility disabilities. A new exercise program was conducted for old people in the exercise group for 6 months. Evaluation between 1st and 24th week included cognitive change, mobility, balance and walking parameters.
RESULTS


Exercise group showed better performance on orientation, memory and language point than before the intervention (P<0.05). Again, the total mental test score of the exercise group significantly increased from 18.7±3.5 to 20.1±3.5 after the intervention (P<0.001). People without a cognitive disorder increased from 8 to 11 in the exercise group (P<0.001), while the number did not change in control group. Correlation was found between exercise group and activities such as mobility, walking and balance performance (r=0.81; P<0.001).
CONCLUSIONS


A multimodal exercise program with intense mental activities enabled an improvement in both cognitive and physical performance in old people with loss of competences due to mobility.",2020,"RESULTS


Exercise group showed better performance on orientation, memory and language point than before the intervention (p<0.05).","['old people in the exercise group for 6 months', 'old people with loss of competences due to mobility', 'elderly people with mobility disabilities', 'elderly with mobility-related disability', '70 old people randomly appointed to the exercise and control groups (35 people for each) with mobility disabilities']","['multimodal exercise program', 'modal exercise intervention', 'Physical exercise interventions', 'new exercise program']","['cognitive and physical performance', 'total mental test score', 'better performance on orientation, memory and language point', 'activities such as mobility, walking and balance performance', 'cognitive disorder', 'cognitive performance and mobility of old people', 'cognitive function and physical performance', 'cognitive change, mobility, balance and walking parameters']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451292', 'cui_str': 'Mental test score'}, {'cui': 'C0205170', 'cui_str': 'Good'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.0554885,"RESULTS


Exercise group showed better performance on orientation, memory and language point than before the intervention (p<0.05).","[{'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Canli', 'Affiliation': 'Department of Elderly Care Program, University of Ankara, Ankara, Turkey - seunal@ankara.edu.tr.'}, {'ForeName': 'Ferda', 'Initials': 'F', 'LastName': 'Ozyurda', 'Affiliation': 'Faculty of Medicine, Department of Internal Medical Sciences, University of Ankara, Ankara, Turkey.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10286-X']
279,32267573,"Impacts of CYP2C19 genetic polymorphisms on bioavailability and effect on platelet adhesion of vicagrel, a novel thienopyridine P2Y 12  inhibitor.","AIMS


We investigated the impacts of CYP2C19 polymorphisms on pharmacokinetics and pharmacodynamics of vicagrel in healthy Chinese subjects.
METHODS


CYP2C19 extensive metabolizers (EMs), intermediate metabolizers (IMs) and poor metabolizers (PMs; 16 subjects/group) participated in a randomized, open-label, 2-period cross-over study. Each study period lasted 7 days, with a loading dose of 24 mg of vicagrel or 300 mg of clopidogrel on day 1, and maintenance doses of 6 mg of vicagrel or 75 mg of clopidogrel daily from day 2 to day 7. The pharmacokinetics and pharmacodynamics were assessed on day 1 and day 7.
RESULTS


After a loading dose, the AUC 0-t  of the active metabolite H4 by vicagrel was slightly lower in IMs and PMs (decreased by 21 and 27%, respectively) compared to EMs. Similar results were found after maintenance doses. In EMs, the AUC 0-t  of H4 by vicagrel was somewhat higher than clopidogrel after the loading dose, and comparable with clopidogrel (90% confidence interval 0.94, 1.21) after the maintenance doses. However, it was much higher than clopidogrel in PMs, with a 1.28-fold (loading dose) and a 73% (maintenance doses) increases compared to clopidogrel (P < 0.001). Consequently, the inhibition of platelet aggregation by vicagrel was greater than clopidogrel after both loading dose (28.2 vs 12.4% at 4 hours, P < 0.01) and maintenance doses (42.8 vs 24.6% at 4 hours, P < 0.001) in PMs.
CONCLUSIONS


CYP2C19 polymorphisms have less impact on vicagrel as compared to clopidogrel. Drug exposure and response to vicagrel in PMs were even higher than to clopidogrel in IMs.",2020,"After a loading dose, the AUC 0-t  of the active metabolite H4 by vicagrel was slightly lower in IMs and PMs (decreased by 21% and 27%, respectively) compared to EMs.","['CYP2C19 extensive metabolizers (EMs), intermediate metabolizers (IMs), and poor metabolizers (PMs) (18 subjects/group', 'healthy Chinese subjects']","['vicagrel or 300 mg of clopidogrel', 'vicagrel or 75 mg of clopidogrel']","['IMs and PMs', 'pharmacokinetics and pharmacodynamics', 'IPA by vicagrel', 'AUC 0-t  of H4 by vicagrel']","[{'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C3501000', 'cui_str': 'methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C3501000', 'cui_str': 'methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0242884,"After a loading dose, the AUC 0-t  of the active metabolite H4 by vicagrel was slightly lower in IMs and PMs (decreased by 21% and 27%, respectively) compared to EMs.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Haijing', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Natural Medicines and Center of Drug Discovery, College of Pharmacy, China Pharmaceutical University, Nanjing, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Lai', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Yongguo', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Hua Medicine Ltd., Shanghai, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Dafang', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14296']
280,32184135,Development of osteoarthritis in patients with degenerative meniscal tears treated with exercise therapy or surgery: a randomized controlled trial.,"OBJECTIVE


To evaluate progression of individual radiographic features 5 years following exercise therapy or arthroscopic partial meniscectomy as treatment for degenerative meniscal tear.
DESIGN


Randomized controlled trial including 140 adults, aged 35-60 years, with a magnetic resonance image verified degenerative meniscal tear, and 96% without definite radiographic knee osteoarthritis. Participants were randomized to either 12-weeks of supervised exercise therapy or arthroscopic partial meniscectomy. The primary outcome was between-group difference in progression of tibiofemoral joint space narrowing and marginal osteophytes at 5 years, assessed semi-quantitatively by the OARSI atlas. Secondary outcomes included incidence of radiographic knee osteoarthritis and symptomatic knee osteoarthritis, medial tibiofemoral fixed joint space width (quantitatively assessed), and patient-reported outcome measures. Statistical analyses were performed using a full analysis set. Per protocol and as treated analysis were also performed.
RESULTS


The risk ratios (95% CI) for progression of semi-quantitatively assessed joint space narrowing and medial and lateral osteophytes for the surgery group were 0.89 (0.55-1.44), 1.15 (0.79-1.68) and 0.77 (0.42-1.42), respectively, compared to the exercise therapy group. In secondary outcomes (full-set analysis) no statistically significant between-group differences were found.
CONCLUSION


The study was inconclusive with respect to potential differences in progression of individual radiographic features after surgical and non-surgical treatment for degenerative meniscal tear. Further, we found no strong evidence in support of differences in development of incident radiographic knee osteoarthritis or patient-reported outcomes between exercise therapy and arthroscopic partial meniscectomy.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT01002794).",2020,"The primary outcome was between-group difference in progression of tibiofemoral joint space narrowing and marginal osteophytes at five years, assessed semi-quantitatively by the OARSI atlas.","['patients with degenerative meniscal tears treated with', 'degenerative meniscal tear', '140 adults, aged 35-60 years, with a magnetic resonance image verified degenerative meniscal tear, and 96% without definite radiographic knee osteoarthritis']","['exercise therapy or surgery', 'exercise therapy or arthroscopic partial meniscectomy', 'supervised exercise therapy or arthroscopic partial meniscectomy']","['incidence of radiographic knee osteoarthritis and symptomatic knee osteoarthritis, medial tibiofemoral fixed joint space width (quantitatively assessed), and patient-reported outcome measures', 'progression of tibiofemoral joint space narrowing and marginal osteophytes at five years, assessed semi-quantitatively by the OARSI atlas', 'progression of semi-quantitatively assessed joint space narrowing and medial and lateral osteophytes', 'risk ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0224497', 'cui_str': 'Articular space (body structure)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1859695'}, {'cui': 'C3698318', 'cui_str': 'Marginal osteophyte'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004171', 'cui_str': 'Atlases'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1956089', 'cui_str': 'Bone Spur'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",140.0,0.12339,"The primary outcome was between-group difference in progression of tibiofemoral joint space narrowing and marginal osteophytes at five years, assessed semi-quantitatively by the OARSI atlas.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Berg', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, Department of Interdisciplinary Health Sciences, University of Oslo, Oslo, Norway. Electronic address: bjornar.berg@studmed.uio.no.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. Electronic address: eroos@health.sdu.dk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Englund', 'Affiliation': 'Faculty of Medicine, Department of Clinical Sciences, Lund, Orthopedics, Clinical Epidemiology Unit, Lund University, Lund, Sweden. Electronic address: martin.englund@med.lu.se.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Kise', 'Affiliation': 'Department of Orthopedic Surgery, Martina Hansens Hospital, Sandvika, Norway. Electronic address: ninakise@hotmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tiulpin', 'Affiliation': 'Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland; Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland. Electronic address: aleksei.tiulpin@oulu.fi.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Saarakkala', 'Affiliation': 'Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland; Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland. Electronic address: simo.saarakkala@oulu.fi.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Engebretsen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Oslo Sports Trauma Research Center, Norwegian School of Sport Sciences, Oslo, Norway; Medical and Scientific Department, International Olympic Committee, Lausanne, Switzerland. Electronic address: lars.engebretsen@medisin.uio.no.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Eftang', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway. Electronic address: cathri.ne@icloud.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Holm', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, Department of Interdisciplinary Health Sciences, University of Oslo, Oslo, Norway. Electronic address: inger.holm@medisin.uio.no.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Risberg', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway. Electronic address: m.a.risberg@nih.no.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.01.020']
281,32251641,"Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial.","BACKGROUND


A monovalent, parenteral, subunit rotavirus vaccine was well tolerated and immunogenic in adults in the USA and in toddlers and infants in South Africa, but elicited poor responses against heterotypic rotavirus strains. We aimed to evaluate safety and immunogenicity of a trivalent vaccine formulation (P2-VP8-P[4],[6],[8]).
METHODS


A double-blind, randomised, placebo-controlled, dose-escalation, phase 1/2 study was done at three South African research sites. Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment. In the dose-escalation phase, adults and toddlers were randomly assigned in blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo. In the expanded phase, infants were randomly assigned in a 1:1:1:1 ratio to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo, in block sizes of four. Participants, parents of participants, and clinical, data, and laboratory staff were masked to treatment assignment. Adults received an intramuscular injection of vaccine or placebo in the deltoid muscle on the day of randomisation (day 0), day 28, and day 56; toddlers received a single injection of vaccine or placebo in the anterolateral thigh on day 0. Infants in both phases received an injection of vaccine or placebo in the anterolateral thigh on days 0, 28, and 56, at approximately 6, 10, and 14 weeks of age. Primary safety endpoints were local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events within 28 days after each injection in all participants who received at least one injection. Primary immunogenicity endpoints were analysed in infants in either phase who received all planned injections, had blood samples analysed at the relevant timepoints, and presented no major protocol violations considered to have an effect on the immunogenicity results of the study, and included serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses measured 4 weeks after the final injection in vaccine compared with placebo groups. This trial is registered with ClinicalTrials.gov, NCT02646891.
FINDINGS


Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group, 140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group) were randomly assigned, received at least one dose, and were assessed for safety. There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups. There were no serious adverse events within 28 days of injection in adults, whereas one serious adverse event occurred in a toddler (febrile convulsion in the 30 μg group) and 23 serious adverse events (four in placebo, ten in 15 μg, four in 30 μg, and five in 90 μg groups) occurred among 20 infants, most commonly respiratory tract infections. One death occurred in an infant within 28 days of injection due to pneumococcal meningitis. In 528 infants (130 in placebo, 132 in 15 μg, 132 in 30 μg, and 134 in 90 μg groups), adjusted anti-P2-VP8 IgG seroresponses (≥4-fold increase from baseline) to P[4], P[6], and P[8] antigens were significantly higher in the 15 μg, 30 μg, and 90 μg groups (99-100%) than in the placebo group (10-29%; p<0·0001). Although significantly higher than in placebo recipients (9-10%), anti-P2-VP8 IgA seroresponses (≥4-fold increase from baseline) to each individual antigen were modest (20-34%) across the 15 μg, 30 μg, and 90 μg groups. Adjusted neutralising antibody seroresponses in infants (≥2·7-fold increase from baseline) to DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]) were higher in vaccine recipients than in placebo recipients: p<0·0001 for all comparisons.
INTERPRETATION


The trivalent P2-VP8 vaccine was well tolerated, with promising anti-P2-VP8 IgG and neutralising antibody responses across the three vaccine P types. Our findings support advancing the vaccine to efficacy testing.
FUNDING


Bill & Melinda Gates Foundation.",2020,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","['528 infants (130 in', '140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group', ""Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment"", 'adults in the USA and in toddlers and infants in South Africa', 'Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group', 'three South African research sites', 'adults and toddlers']","['vaccine or placebo', 'parenteral trivalent P2-VP8 subunit rotavirus vaccine', 'placebo', 'intramuscular injection of vaccine or placebo', 'vaccine, or placebo', 'blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo', 'trivalent vaccine formulation (P2-VP8-P[4],[6],[8']","['serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses', 'serious adverse events', 'One death', 'local or systemic adverse events, or unsolicited adverse events', 'safety and immunogenicity', 'Safety and immunogenicity', '23 serious adverse events', 'Adjusted neutralising antibody seroresponses', 'local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events', 'adjusted anti-P2-VP8 IgG seroresponses', 'anti-P2-VP8 IgA seroresponses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",4.0,0.743237,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Groome', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: groomem@rmpru.co.za.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Family Clinical Research Unit, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Maysseb', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'PATH, Washington, DC, USA; Novavax, Gaithersburg, MD, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Power', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cryz', 'Affiliation': 'PATH, Washington, DC, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30001-3']
282,32173628,Long-term effect of patient decision aids on use of joint replacement and health care costs.,"OBJECTIVE


Shared decision-making supported by patient decisions aids may improve care and reduce healthcare costs for persons considering total joint replacement. Observational studies and randomized controlled trials (RCTs) have evaluated the short-term impact of decision aids on uptake of surgery and costs, however the long-term effects are unclear. This analysis aimed to evaluate the effect of patient decision aids on 1) use of joint replacement up to 7-years of follow-up, and 2) osteoarthritis-related health system costs.
METHODS


324 participants in a Canadian RCT with 2-years follow-up who were randomized to either a decision aid (n = 161) or usual care (n = 163) had their trial and health administrative data linked. The proportion undergoing surgery up to 7-years were compared using cumulative incidence plots and competing risk regression. Mean per-patient costs were compared using two sample t-tests.
RESULTS


At 2-years, 119 of 161 (73.9%) patients in the decision aid arm and 129 of 163 (79.1%) patients in the usual care arm had surgery. Between two and 7-years, 17 additional patients in both the decision aid (of 42, 40.4%) and usual care (of 34, 50.0%) arms underwent surgery. At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
CONCLUSIONS


This is the first study to assess the long-term impact of decision aids on use of joint replacement and healthcare costs. These results are not conclusive but can inform future trial design.
CLINICAL TRIAL REGISTRATION


The full trial protocol is available at ClinicalTrials.Gov (NCT00911638).",2020,"At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
","['324 participants in a Canadian RCT with 2-years follow-up who were randomized to either a decision aid (n\xa0=\xa0161) or usual care (n\xa0=\xa0163) had their trial and health administrative data linked', 'persons considering total joint replacement']","['patient decision aids', 'decision aids']","['usual care', 'mean per-patient costs', 'Mean per-patient costs', 'likelihood of undergoing surgery']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",,0.137968,"At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trenaman', 'Affiliation': 'University of British Columbia, Vancouver, Canada; Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bryan', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Payne', 'Affiliation': 'The University of Manchester, Manchester, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hawker', 'Affiliation': 'The University of Toronto, Toronto, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bansback', 'Affiliation': 'University of British Columbia, Vancouver, Canada; Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada. Electronic address: nick.bansback@ubc.ca.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.01.019']
283,32210245,Effects of Chlorhexidine mouthwash on the oral microbiome.,"Following a single blind, cross-over and non-randomized design we investigated the effect of 7-day use of chlorhexidine (CHX) mouthwash on the salivary microbiome as well as several saliva and plasma biomarkers in 36 healthy individuals. They rinsed their mouth (for 1 min) twice a day for seven days with a placebo mouthwash and then repeated this protocol with CHX mouthwash for a further seven days. Saliva and blood samples were taken at the end of each treatment to analyse the abundance and diversity of oral bacteria, and pH, lactate, glucose, nitrate and nitrite concentrations. CHX significantly increased the abundance of Firmicutes and Proteobacteria, and reduced the content of Bacteroidetes, TM7, SR1 and Fusobacteria. This shift was associated with a significant decrease in saliva pH and buffering capacity, accompanied by an increase in saliva lactate and glucose levels. Lower saliva and plasma nitrite concentrations were found after using CHX, followed by a trend of increased systolic blood pressure. Overall, this study demonstrates that mouthwash containing CHX is associated with a major shift in the salivary microbiome, leading to more acidic conditions and lower nitrite availability in healthy individuals.",2020,"CHX significantly increased the abundance of Firmicutes and Proteobacteria, and reduced the content of Bacteroidetes, TM7, SR1 and Fusobacteria.","['36 healthy individuals', 'healthy individuals']","['CHX', 'mouthwash containing CHX', 'chlorhexidine (CHX) mouthwash', 'Chlorhexidine']","['abundance and diversity of oral bacteria, and pH, lactate, glucose, nitrate and nitrite concentrations', 'systolic blood pressure', 'Saliva and blood samples', 'saliva pH and buffering capacity', 'Lower saliva and plasma nitrite concentrations', 'saliva lactate and glucose levels', 'abundance of Firmicutes and Proteobacteria, and reduced the content of Bacteroidetes, TM7, SR1 and Fusobacteria']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3666901', 'cui_str': 'Chlorhexidine Mouthwash [Paroex]'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C1254144', 'cui_str': 'Firmicutes'}, {'cui': 'C0751985', 'cui_str': 'Purple Bacteria'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0995456', 'cui_str': 'Bacteroidetes'}, {'cui': 'C1222477', 'cui_str': 'Class Fusobacteria (organism)'}]",36.0,0.0846074,"CHX significantly increased the abundance of Firmicutes and Proteobacteria, and reduced the content of Bacteroidetes, TM7, SR1 and Fusobacteria.","[{'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Bescos', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK. Raul.Bescos@plymouth.ac.uk.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashworth', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Cutler', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Zoe L', 'Initials': 'ZL', 'LastName': 'Brookes', 'Affiliation': 'Peninsula Dental School, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Belfield', 'Affiliation': 'Peninsula Dental School, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodiles', 'Affiliation': 'School of Biological and Marine Sciences, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Casas-Agustench', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Farnham', 'Affiliation': 'Peninsula Medical School, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Liddle', 'Affiliation': 'School of Social Sciences, Bishop Grosseteste University, Lincolnshire, LN1 3DY, UK.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Burleigh', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, South Lanarkshire, G72 0LH, UK.'}, {'ForeName': 'Desley', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Easton', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, South Lanarkshire, G72 0LH, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}]",Scientific reports,['10.1038/s41598-020-61912-4']
284,32202316,Treatment of newly diagnosed glioblastoma in the elderly: a network meta-analysis.,"BACKGROUND


A glioblastoma is a fatal type of brain tumour for which the standard of care is maximum surgical resection followed by chemoradiotherapy, when possible. Age is an important consideration in this disease, as older age is associated with shorter survival and a higher risk of treatment-related toxicity.
OBJECTIVES


To determine the most effective and best-tolerated approaches for the treatment of elderly people with newly diagnosed glioblastoma. To summarise current evidence for the incremental resource use, utilities, costs and cost-effectiveness associated with these approaches.
SEARCH METHODS


We searched electronic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase to 3 April 2019, and the NHS Economic Evaluation Database (EED) up to database closure. We handsearched clinical trial registries and selected neuro-oncology society conference proceedings from the past five years.
SELECTION CRITERIA


Randomised trials (RCTs) of treatments for glioblastoma in elderly people. We defined 'elderly' as 70+ years but included studies defining 'elderly' as over 65+ years if so reported.
DATA COLLECTION AND ANALYSIS


We used standard Cochrane methods for study selection and data extraction. Where sufficient data were available, treatment options were compared in a network meta-analysis (NMA) using Stata software (version 15.1). For outcomes with insufficient data for NMA, pairwise meta-analysis were conducted in RevMan. The GRADE approach was used to grade the evidence.
MAIN RESULTS


We included 12 RCTs involving approximately 1818 participants. Six were conducted exclusively among elderly people (either defined as 65 years or older or 70 years or older) with newly diagnosed glioblastoma, the other six reported data for an elderly subgroup among a broader age range of participants. Most participants were capable of self-care. Study quality was commonly undermined by lack of outcome assessor blinding and attrition. NMA was only possible for overall survival; other analyses were pair-wise meta-analyses or narrative syntheses. Seven trials contributed to the NMA for overall survival, with interventions including supportive care only (one trial arm); hypofractionated radiotherapy (RT40; four trial arms); standard radiotherapy (RT60; five trial arms); temozolomide (TMZ; three trial arms); chemoradiotherapy (CRT; three trial arms); bevacizumab with chemoradiotherapy (BEV_CRT; one trial arm); and bevacizumab with radiotherapy (BEV_RT). Compared with supportive care only, NMA evidence suggested that all treatments apart from BEV_RT prolonged survival to some extent. Overall survival High-certainty evidence shows that CRT prolongs overall survival (OS) compared with RT40 (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.56 to 0.80) and low-certainty evidence suggests that CRT may prolong overall survival compared with TMZ (TMZ versus CRT: HR 1.42, 95% CI 1.01 to 1.98). Low-certainty evidence also suggests that adding BEV to CRT may make little or no difference (BEV_CRT versus CRT: HR 0.83, 95% CrI 0.48 to 1.44). We could not compare the survival effects of CRT with different radiotherapy fractionation schedules (60 Gy/30 fractions and 40 Gy/15 fractions) due to a lack of data. When treatments were ranked according to their effects on OS, CRT ranked higher than TMZ, RT and supportive care only, with the latter ranked last. BEV plus RT was the only treatment for which there was no clear benefit in OS over supportive care only.   One trial comparing tumour treating fields (TTF) plus adjuvant chemotherapy (TTF_AC) with adjuvant chemotherapy alone could not be included in the NMA as participants were randomised after receiving concomitant chemoradiotherapy, not before. Findings from the trial suggest that the intervention probably improves overall survival in this selected patient population. We were unable to perform NMA for other outcomes due to insufficient data. Pairwise analyses were conducted for the following. Quality of life Moderate-certainty narrative evidence suggests that overall, there may be little difference in QoL between TMZ and RT, except for discomfort from communication deficits, which are probably more common with RT (1 study, 306 participants, P = 0.002). Data on QoL for other comparisons were sparse, partly due to high dropout rates, and the certainty of the evidence tended to be low or very low. Progression-free survival High-certainty evidence shows that CRT increases time to disease progression compared with RT40 (HR 0.50, 95% CI 0.41 to 0.61); moderate-certainty evidence suggests that RT60 probably increases time to disease progression compared with supportive care only (HR 0.28, 95% CI 0.17 to 0.46), and that BEV_RT probably increases time to disease progression compared with RT40 alone (HR 0.46, 95% CI 0.27 to 0.78). Evidence for other treatment comparisons was of low- or very low-certainty. Severe adverse events Moderate-certainty evidence suggests that TMZ probably increases the risk of grade 3+ thromboembolic events compared with RT60 (risk ratio (RR) 2.74, 95% CI 1.26 to 5.94; participants = 373; studies = 1) and also the risk of grade 3+ neutropenia, lymphopenia, and thrombocytopenia. Moderate-certainty evidence also suggests that CRT probably increases the risk of grade 3+ neutropenia, leucopenia and thrombocytopenia compared with hypofractionated RT alone. Adding BEV to CRT probably increases the risk of thromboembolism (RR 16.63, 95% CI 1.00 to 275.42; moderate-certainty evidence). Economic evidence There is a paucity of economic evidence regarding the management of newly diagnosed glioblastoma in the elderly. Only one economic evaluation on two short course radiotherapy regimen (25 Gy versus 40 Gy) was identified and its findings were considered unreliable.
AUTHORS' CONCLUSIONS


For elderly people with glioblastoma who are self-caring, evidence suggests that CRT prolongs survival compared with RT and may prolong overall survival compared with TMZ alone. For those undergoing RT or TMZ therapy, there is probably little difference in QoL overall. Systemic anti-cancer treatments TMZ and BEV carry a higher risk of severe haematological and thromboembolic events and CRT is probably associated with a higher risk of these events. Current evidence provides little justification for using BEV in elderly patients outside a clinical trial setting. Whilst the novel TTF device appears promising, evidence on QoL and tolerability is needed in an elderly population. QoL and economic assessments of CRT versus TMZ and RT are needed. More high-quality economic evaluations are needed, in which a broader scope of costs (both direct and indirect) and outcomes should be included.",2020,"When treatments were ranked according to their effects on OS, CRT ranked higher than TMZ, RT and supportive care only, with the latter ranked last.","['newly diagnosed glioblastoma in the elderly', 'elderly people with newly diagnosed glioblastoma', 'Six were conducted exclusively among elderly people (either defined as 65 years or older or 70 years or older) with newly diagnosed glioblastoma, the other six reported data for an elderly subgroup among a broader age range of participants', '12 RCTs involving approximately 1818 participants', 'elderly people', ""elderly' as 70+ years but included studies defining 'elderly' as over 65+ years if so reported"", 'elderly patients', 'elderly people with glioblastoma who are self-caring']","['tumour treating fields (TTF) plus adjuvant chemotherapy (TTF_AC) with adjuvant chemotherapy alone', 'temozolomide (TMZ', 'glioblastoma', 'NMA', 'CRT versus TMZ', 'bevacizumab with radiotherapy (BEV_RT', 'TMZ (TMZ', 'CRT', 'bevacizumab with chemoradiotherapy (BEV_CRT', 'standard radiotherapy', 'TMZ', 'chemoradiotherapy (CRT', 'hypofractionated radiotherapy', 'concomitant chemoradiotherapy']","['risk of grade 3+ thromboembolic events', 'risk of grade 3+ neutropenia, leucopenia and thrombocytopenia', 'overall survival', 'QoL and tolerability', 'overall survival (OS', 'Overall survival', 'risk of grade 3+ neutropenia, lymphopenia, and thrombocytopenia', 'risk of thromboembolism', 'survival effects', 'time to disease progression']","[{'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",306.0,0.552052,"When treatments were ranked according to their effects on OS, CRT ranked higher than TMZ, RT and supportive care only, with the latter ranked last.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanna', 'Affiliation': 'University of Glasgow, Department of Oncology, Beatson West of Scotland Cancer Centre, Great Western Road, Glasgow, Scotland, UK, G4 9DL.'}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Lawrie', 'Affiliation': 'The Evidence-Based Medicine Consultancy Ltd, 3rd Floor Northgate House, Upper Borough Walls, Bath, UK, BA1 1RG.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Rogozińska', 'Affiliation': 'The Evidence-Based Medicine Consultancy Ltd, 3rd Floor Northgate House, Upper Borough Walls, Bath, UK, BA1 1RG.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Kernohan', 'Affiliation': 'Newcastle University, Institute of Health & Society, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, UK, NE2 4AA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jefferies', 'Affiliation': ""Addenbrooke's Hospital, Department of Oncology, Hills Road, Cambridge, UK, CB2 0QQ.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bulbeck', 'Affiliation': 'brainstrust, Director of Services, 4 Yvery Court, Castle Road, Cowes, Isle of Wight, UK, PO31 7QG.'}, {'ForeName': 'Usama M', 'Initials': 'UM', 'LastName': 'Ali', 'Affiliation': 'University of Oxford, Centre for Statistics in Medicine, 7 Dewsbury Road, Luton, Bedfordshire, UK, LU3 2HJ.'}, {'ForeName': 'Tomos', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Newcastle University, Institute of Health & Society, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, UK, NE2 4AA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Western General Hospital, Edinburgh Centre for Neuro-Oncology (ECNO), Crewe Road, Edinburgh, Scotland, UK, EH4 2XU.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013261.pub2']
285,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
286,30632971,The QuitIT Coping Skills Game for Promoting Tobacco Cessation Among Smokers Diagnosed With Cancer: Pilot Randomized Controlled Trial.,"BACKGROUND


Although smoking cessation apps have become popular, few have been tested in randomized clinical trials or undergone formative evaluation with target users.
OBJECTIVE


We developed a cessation app targeting tobacco-dependent cancer patients. Game design and behavioral rehearsal principles were incorporated to help smokers identify, model, and practice coping strategies to avoid relapse to smoking. In this randomized pilot trial, we examined feasibility (recruitment and retention rates), acceptability (patient satisfaction), quitting self-confidence, and other cessation-related indices to guide the development of a larger trial.
METHODS


We randomized 42 English-speaking cancer patients scheduled for surgical treatment to either the Standard Care (SC; telecounseling and cessation pharmacotherapies) or the experimental QuitIT study arm (SC and QuitIT game). Gameplay parameters were captured in-game; satisfaction with the game was assessed at 1-month follow-up. We report study screening, exclusion, and refusal reasons; compare refusal and attrition by key demographic and clinical variables; and report tobacco-related outcomes.
RESULTS


Follow-up data were collected from 65% (13/20) patients in the QuitIT and 61% (11/18) in SC arms. Study enrollees were 71% (27/38) females, 92% (35/38) white people, and 95% (36/38) non-Hispanic people. Most had either lung (12/38, 32%) or gastrointestinal (9/38, 24%) cancer. Those dropping out were less likely than completers to have used a tablet (P<.01) and have played the game at all (P=.02) and more likely to be older (P=.05). Of 20 patients in the QuitIT arm, 40% (8/20) played the game (system data). There were no differences between those who played and did not play by demographic, clinical, technology use, and tobacco-related variables. Users completed an average of 2.5 (SD 4.0) episodes out of 10. A nonsignificant trend was found for increased confidence to quit in the QuitIT arm (d=0.25, 95% CI -0.56 to 1.06), and more participants were abstinent in the QuitIT group than in the SC arm (4/13, 30%, vs 2/11, 18%). Satisfaction with gameplay was largely positive, with most respondents enjoying use, relating to the characters, and endorsing that gameplay helped them cope with actual smoking urges.
CONCLUSIONS


Recruitment and retention difficulties suggest that the perihospitalization period may be a less than ideal time for delivering a smoking cessation app intervention. Framing of the app as a ""game"" may have decreased receptivity as participants may have been preoccupied with hospitalization demands and illness concerns. Less tablet experience and older age were associated with participant dropout. Although satisfaction with the gameplay was high, 60% (12/20) of QuitIT participants did not play the game. Paying more attention to patient engagement, changing the intervention delivery period, providing additional reward and support for use, and improving cessation app training may bolster feasibility for a larger trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01915836; https://clinicaltrials.gov/ct2/show/NCT01915836 (Archived by WebCite at http://www.webcitation.org/73vGsjG0Y).",2019,Those dropping out were less likely than completers to have used a tablet (P<.01) and have played the game at all (P=.02) and more likely to be older (P=.05).,"['tobacco-dependent cancer patients', '42 English-speaking cancer patients scheduled for surgical treatment to either the', 'Diagnosed With Cancer', 'Study enrollees were 71% (27/38) females, 92% (35/38) white people, and 95% (36/38) non-Hispanic people', 'Of 20 patients in the QuitIT arm, 40% (8/20) played the game (system data', 'Smokers']","['QuitIT Coping Skills Game', 'Standard Care (SC; telecounseling and cessation pharmacotherapies']","['feasibility (recruitment and retention rates), acceptability (patient satisfaction), quitting self-confidence', 'confidence to quit']","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",42.0,0.187493,Those dropping out were less likely than completers to have used a tablet (P<.01) and have played the game at all (P=.02) and more likely to be older (P=.05).,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Krebs', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, United States.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Burkhalter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Fiske', 'Affiliation': 'Muzzy Lane Software, Newburyport, MA, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Snow', 'Affiliation': 'Muzzy Lane Software, Newburyport, MA, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iocolano', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borderud', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, United States.'}]",JMIR mHealth and uHealth,['10.2196/10071']
287,31151363,Differential modulatory effects of Propofol and Sevoflurane anesthesia on blood monocyte HLA-DR and CD163 expression during and after cardiac surgery with cardiopulmonary bypass: a preliminary randomized flow cytometry study.,"INTRODUCTION


The increase of the anti-inflammatory CD163 high HLA-DR low  blood monocyte subset is one of the mechanisms dampening inflammation during cardiac surgery with cardiopulmonary bypass. We evaluated the effect of two different anesthetic protocols, intravenous Propofol infusion or Sevoflurane-gas administration, on the perioperative frequency of this subset.
METHODS


Blood from patients (Propofol = 11, Sevoflurane = 13) undergoing minimally invasive mitral valve surgery was drawn preoperatively (T1), before declamping (T2), at 6 (T3), 24 (T4), 48 (T5), and 72 hours (T6) after declamping. C-reactive protein, haptoglobin, and lactate dehydrogenase were measured. A hemolytic index, as C-reactive protein/haptoglobin ratio, was introduced. Monocyte expression of HLA-DR, CD163, and the CD163 high HLA-DR low  subset fraction was quantified by flow cytometry. Baseline-referred variations of plasmatic and cellular data at T2 were normalized for clamping times. Subsequent time-point variations were normalized for the final cardiopulmonary bypass times.
RESULTS


Variations of hemolytic index and lactate dehydrogenase were higher with Propofol at T3 (p = 0.004 and p = 0.02, respectively) when compared with Sevoflurane. At T2, the down-modulation of CD163 was higher with Propofol (p = 0.005). Starting from T3, the up-regulatory trend of CD163 was basically higher with Propofol, although not significantly. Propofol induced higher increments of HLA-DR low fractions, at T2 (p = 0.04) and, to a lesser extent, at T4 (p = 0.06). Starting from T3, the CD163 high HLA-DR low  subset variations were higher with Propofol, especially at T4 and T6.
CONCLUSION


Propofol seems to induce a higher postoperative fraction of the CD163 high HLA-DR low  monocyte subset. This could represent either a compensatory mechanism dampening the higher inflammatory condition observed with Propofol at T2 or a consequence of a higher postoperative Propofol-induced hemolysis.",2020,"At T2, the down-modulation of CD163 was higher with Propofol (p = 0.005).","['cardiac surgery with cardiopulmonary bypass', 'Blood from patients (Propofol\u2009=\u200911, Sevoflurane\u2009=\u200913) undergoing']","['Propofol infusion or Sevoflurane-gas administration', 'minimally invasive mitral valve surgery', 'Propofol and Sevoflurane anesthesia', 'Propofol', 'Sevoflurane']","['hemolytic index and lactate dehydrogenase', 'CD163 high HLA-DR low  subset variations', 'HLA-DR low fractions', 'C-reactive protein, haptoglobin, and lactate dehydrogenase', 'Monocyte expression of HLA-DR, CD163, and the CD163 high HLA-DR low  subset fraction', 'blood monocyte HLA-DR and CD163 expression']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0005768'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0312853', 'cui_str': 'Hemolytic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",13.0,0.0181821,"At T2, the down-modulation of CD163 was higher with Propofol (p = 0.005).","[{'ForeName': 'Silverio', 'Initials': 'S', 'LastName': 'Sbrana', 'Affiliation': 'Flow Cytometry Laboratory, CNR Institute of Clinical Physiology, Ospedale del Cuore, Massa, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nunziata', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Storti', 'Affiliation': 'Unit of Laboratory Medicine, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.'}, {'ForeName': 'Dorela', 'Initials': 'D', 'LastName': 'Haxhiademi', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Mazzone', 'Affiliation': 'Adult Cardiology Department, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Leone', 'Affiliation': 'Perfusion Unit, Cardiothoracic Department, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Solinas', 'Affiliation': 'Adult Cardiac Surgery Department, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Del Sarto', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio, Massa, Italy.'}]",Perfusion,['10.1177/0267659119848295']
288,30285042,Effect of Increased Daily Water Intake in Premenopausal Women With Recurrent Urinary Tract Infections: A Randomized Clinical Trial.,"Importance


Increased hydration is often recommended as a preventive measure for women with recurrent cystitis, but supportive data are sparse.
Objective


To assess the efficacy of increased daily water intake on the frequency of recurrent cystitis in premenopausal women.
Design, Setting, and Participants


Randomized, open-label, controlled, 12-month trial at a clinical research center (years 2013-2016). Among 163 healthy women with recurrent cystitis (≥3 episodes in past year) drinking less than 1.5 L of fluid daily assessed for eligibility, 23 were excluded and 140 assigned to water or control group. Assessments of daily fluid intake, urinary hydration, and cystitis symptoms were performed at baseline, 6- and 12-month visits, and monthly telephone calls.
Interventions


Participants were randomly assigned to drink, in addition to their usual fluid intake, 1.5 L of water daily (water group) or no additional fluids (control group) for 12 months.
Main Outcomes and Measures


Primary outcome measure was frequency of recurrent cystitis over 12 months. Secondary outcomes were number of antimicrobial regimens used, mean time interval between cystitis episodes, and 24-hour urinary hydration measurements.
Results


The mean (SD) age of the 140 participants was 35.7 (8.4) years, and the mean (SD) number of cystitis episodes in the previous year was 3.3 (0.6). During the 12-month study period, the mean (SD) number of cystitis episodes was 1.7 (95% CI, 1.5-1.8) in the water group compared with 3.2 (95% CI, 3.0-3.4) in the control group, with a difference in means of 1.5 (95% CI, 1.2-1.8; P < .001). Overall, there were 327 cystitis episodes, 111 in the water group and 216 in the control group. The mean number of antimicrobial regimens used to treat cystitis episodes was 1.9 (95% CI, 1.7-2.2) and 3.6 (95% CI, 3.3-4.0), respectively, with a difference in means of 1.7 (95% CI, 1.3-2.1; P < .001). The mean time interval between cystitis episodes was 142.8 (95% CI, 127.4-160.1) and 84.4 (95% CI, 75.4-94.5) days, respectively, with a difference in means of 58.4 (95% CI, 39.4-77.4; P < .001). Between baseline and 12 months, participants in the water group, compared with those in the control group, had increased mean (SD) urine volume (1.4 [0.04] vs 0.1 [0.04] L; P < .001) and voids (2.4 [0.2] vs -0.1 [0.2]; P < .001) and decreased urine osmolality (-402.8 [19.6] vs -24.0 [19.5] mOsm/kg; P < .001).
Conclusions and Relevance


Increased water intake is an effective antimicrobial-sparing strategy to prevent recurrent cystitis in premenopausal women at high risk for recurrence who drink low volumes of fluid daily.
Trial Registration


ClinicalTrials.gov identifier: NCT02444975.",2018,"Between baseline and 12 months, participants in the water group, compared with those in the control group, had increased mean (SD) urine volume (1.4 [0.04] vs 0.1 [0.04] L; P < .001) and voids (2.4 [0.2] vs -0.1 [0.2]; P < .001) and decreased urine osmolality (-402.8 [19.6]","['women with recurrent cystitis', 'premenopausal women at high risk for recurrence who drink low volumes of fluid daily', '163 healthy women with recurrent cystitis (≥3 episodes in past year) drinking less than 1.5 L of fluid daily assessed for eligibility, 23 were excluded and 140 assigned to water or control group', 'Premenopausal Women With Recurrent Urinary Tract Infections', 'premenopausal women']","['drink, in addition to their usual fluid intake, 1.5 L of water daily (water group) or no additional fluids (control group) for 12 months', 'Increased Daily Water Intake']","['mean (SD) number of cystitis episodes', 'urine osmolality', 'mean number of antimicrobial regimens used to treat cystitis episodes', 'cystitis episodes', 'mean (SD) urine volume', 'daily fluid intake, urinary hydration, and cystitis symptoms', 'frequency of recurrent cystitis', 'mean time interval between cystitis episodes', 'number of antimicrobial regimens used, mean time interval between cystitis episodes, and 24-hour urinary hydration measurements']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0581366', 'cui_str': 'Recurrent cystitis (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection (disorder)'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine (procedure)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0581366', 'cui_str': 'Recurrent cystitis (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",163.0,0.260089,"Between baseline and 12 months, participants in the water group, compared with those in the control group, had increased mean (SD) urine volume (1.4 [0.04] vs 0.1 [0.04] L; P < .001) and voids (2.4 [0.2] vs -0.1 [0.2]; P < .001) and decreased urine osmolality (-402.8 [19.6]","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Hooton', 'Affiliation': 'Department of Medicine, School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Vecchio', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Iroz', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Tack', 'Affiliation': 'Service des Explorations Fonctionnelles Physiologiques, CHU de Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Dornic', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Seksek', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Lotan', 'Affiliation': 'Department of Urology, University of Texas Southwestern Medical Center, Dallas.'}]",JAMA internal medicine,['10.1001/jamainternmed.2018.4204']
289,32247598,Laparoscopic-guided versus transincisional rectus sheath block for pediatric single-incision laparoscopic cholecystectomy: A randomized controlled trial.,"PURPOSE


The purpose of our study was to compare the effectiveness of transincisional (TI) versus laparoscopic-guided (LG) rectus sheath block (RSB) for pain control following pediatric single-incision laparoscopic cholecystectomy (SILC).
METHODS


Forty-eight patients 10-21 years old presenting to a single institution for SILC from 2015 to 2018 were randomized to TI or LG RSB. Apart from RSB technique, perioperative care protocols were identical between groups. Pain scores were assessed with validated measures upon arrival in the postanesthesia care unit (PACU) and at regular intervals until discharge. The patients and those assessing them were blinded to RSB technique. The primary outcome was pain score 60 min after PACU arrival. Secondary outcomes included pain scores throughout the PACU stay, opioids (reported as morphine milligram equivalents (MME) per kg bodyweight) administered in PACU, length of stay, outpatient pain scores and opioid use, and adverse events. Groups were compared on outcomes using t test and generalized estimating equations for continuous variables and Fisher's exact test for categorical variables with significance at α = 0.05.
RESULTS


Mean age of the 48 subjects was 15 years (range = 11-20). The majority (79%) were female. Indications for surgery included symptomatic cholelithiasis (n = 41), acute cholecystitis (n = 4), gallstone pancreatitis (n = 2) and choledocholithiasis (n = 1). Mean (standard deviation) operative time was 61 (±23) min overall. No statistically significant differences in demographics, indication, operative time, or intraoperative analgesia were observed between TI (n = 24) and LG (n = 24) groups. The mean 60-min pain score was 3.4 (±2.6) in the LG group versus 3.8 (±2.1) in the TI group (p = 0.573). No significant differences were detected between groups in overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications. Overall, mean opioid use was 0.1 MME/kg in the PACU and 0.5 MME/kg in the outpatient setting. Mean postoperative length of stay was 0.2 day. There were no major complications.
CONCLUSION


Laparoscopic-guided rectus sheath block is not superior to transincisional rectus sheath block for pain control following pediatric single-incision laparoscopic cholecystectomy. The single-incision laparoscopic approach combined with rectus sheath block resulted in effective pain control, low opioid use, and expedited length of stay with no major complications.
LEVEL OF EVIDENCE


Level I, treatment study, randomized controlled trial.",2020,"No significant differences were detected between groups in overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications.","['surgery included symptomatic cholelithiasis (n\u202f=\u202f41), acute cholecystitis (n\u202f=\u202f4), gallstone pancreatitis (n\u202f=\u202f2) and choledocholithiasis (n\u202f=\u202f1', '10-21\u202fyears old presenting to a single institution for SILC from 2015 to 2018 were randomized to', 'pain control following pediatric single-incision laparoscopic cholecystectomy (SILC', 'Forty-eight patients', 'Mean age of the 48 subjects was 15\u202fyears (range\u202f=\u202f11-20']","['TI or LG RSB', 'pediatric single-incision laparoscopic cholecystectomy', 'rectus sheath block', 'Laparoscopic-guided versus transincisional rectus sheath block', 'transincisional (TI) versus laparoscopic-guided (LG) rectus sheath block (RSB', 'Laparoscopic-guided rectus sheath block']","['pain scores throughout the PACU stay, opioids (reported as morphine milligram equivalents (MME) per kg bodyweight) administered in PACU, length of stay, outpatient pain scores and opioid use, and adverse events', 'pain score 60\u202fmin after PACU arrival', 'Pain scores', 'Mean postoperative length of stay', 'overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications', 'effective pain control, low opioid use, and expedited length of stay with no major complications', 'Mean (standard deviation) operative time', 'demographics, indication, operative time, or intraoperative analgesia', 'mean 60-min pain score']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C0521614', 'cui_str': 'Gallstone pancreatitis'}, {'cui': 'C0701818', 'cui_str': 'Cholelithiasis, Common Bile Duct'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",,0.177008,"No significant differences were detected between groups in overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications.","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Kauffman', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: jkauff10@jhu.edu.""}, {'ForeName': 'Anh Thy H', 'Initials': 'ATH', 'LastName': 'Nguyen', 'Affiliation': ""Department of Health Informatics, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: anguye57@jhmi.edu.""}, {'ForeName': 'Cristen N', 'Initials': 'CN', 'LastName': 'Litz', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: clitz@health.usf.edu.""}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Farach', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: sandrafarach@gmail.com.""}, {'ForeName': 'JoAnn C', 'Initials': 'JC', 'LastName': 'DeRosa', 'Affiliation': ""Clinical and Translational Research Organization, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: joann.derosa@jhmi.edu.""}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: rgonza35@jhmi.edu.""}, {'ForeName': 'Ernest K', 'Initials': 'EK', 'LastName': 'Amankwah', 'Affiliation': ""Department of Health Informatics, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: ernest.amankwah@jhmi.edu.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Danielson', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: paul.danielson@jhmi.edu.""}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Chandler', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: nicole.chandler@jhmi.edu.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.03.002']
290,32210349,Iron bioavailability from bouillon fortified with a novel ferric phytate compound: a stable iron isotope study in healthy women (part II).,"Bouillon cubes are widely consumed and when fortified with iron could contribute in preventing iron deficiency. We report the development (part I) and evaluation (current part II) of a novel ferric phytate compound to be used as iron fortificant in condiments such as bouillon. Ferric pyrophosphate (FePP), is the compound of choice due to its high stability in foods, but has a modest absorption in humans. Our objective was to assess iron bioavailability from a novel iron fortificant consisting of ferric iron complexed with phytic acid and hydrolyzed corn protein (Fe-PA-HCP), used in bouillon with and without an inhibitory food matrix. In a randomised single blind, cross-over study, we measured iron absorption in healthy adult women (n = 22). In vitro iron bioaccessibility was assessed using a Caco-2 cell model. Iron absorption from Fe-PA-HCP was 1.5% and 4.1% in bouillon with and without inhibitory matrix, respectively. Relative iron bioavailability to FeSO 4  was 2.4 times higher than from FePP in bouillon (17% vs 7%) and 5.2 times higher when consumed with the inhibitory meal (41% vs 8%). Similar results were found in vitro. Fe-PA-HCP has a higher relative bioavailability versus FePP, especially when bouillon is served with an inhibitory food matrix.",2020,"Fe-PA-HCP has a higher relative bioavailability versus FePP, especially when bouillon is served with an inhibitory food matrix.","['healthy adult women (n\u2009=\u200922', 'healthy women (part II']","['ferric iron complexed with phytic acid and hydrolyzed corn protein (Fe-PA-HCP', 'Ferric pyrophosphate (FePP']","['iron bioavailability', 'Relative iron bioavailability', 'Iron bioavailability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0031855', 'cui_str': 'Phytic Acid'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0117541', 'cui_str': 'ferric pyrophosphate'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0358728,"Fe-PA-HCP has a higher relative bioavailability versus FePP, especially when bouillon is served with an inhibitory food matrix.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Dold', 'Affiliation': 'ETH Zurich, Laboratory of Human Nutrition, Zurich, Switzerland.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'ETH Zurich, Laboratory of Human Nutrition, Zurich, Switzerland.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'Jeroense', 'Affiliation': 'ETH Zurich, Laboratory of Human Nutrition, Zurich, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zeder', 'Affiliation': 'ETH Zurich, Laboratory of Human Nutrition, Zurich, Switzerland.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Habeych', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Galaffu', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Grathwohl', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Tajeri Foman', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Merinat', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rey', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Sabatier', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Moretti', 'Affiliation': 'ETH Zurich, Laboratory of Human Nutrition, Zurich, Switzerland. diego.moretti@alumni.ethz.ch.'}]",Scientific reports,['10.1038/s41598-020-62307-1']
291,31795035,Stability of frontal alpha asymmetry in depressed patients during antidepressant treatment.,"INTRODUCTION


Frontal alpha asymmetry (FAA) is a proposed prognostic biomarker in major depressive disorder (MDD), conventionally acquired with electroencephalography (EEG). Although small studies attributed trait-like properties to FAA, a larger sample is needed to reliably asses this characteristic. Furthermore, to use FAA to predict treatment response, determining its stability, including the potential dependency on depressive state or medication, is essential.
METHODS


In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to treatment with escitalopram, sertraline or venlafaxine-extended release. Treatment response was established eight weeks after treatment initiation and resting state EEG was measured both at baseline and after eight weeks (n = 453).
RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity. After randomizing females to escitalopram or sertraline, for whom treatment response could be predicted in an earlier study, FAA after eight weeks resulted in equivalent response prediction as baseline FAA (one tailed p = .028).
CONCLUSION


We demonstrate that FAA is a stable trait, robust to time, state and pharmacological status. This confirms FAA stability. Furthermore, as prediction of treatment response is irrespective of moment of measurement and use of medication, FAA can be used as a state-invariant prognostic biomarker with promise to optimize MDD treatments.",2019,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","['1008 MDD participants', 'depressed patients during antidepressant treatment']","['escitalopram, sertraline or venlafaxine-extended release', 'FAA', 'Frontal alpha asymmetry (FAA', 'sertraline']","['resting state EEG', 'Stability of frontal alpha asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",1008.0,0.02721,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Synaeda Psycho Medisch Centrum, Leeuwarden, The Netherlands; Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'Madelon A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102056']
292,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992']
293,32234665,Randomised phase II trial (SWOG S1310) of single agent MEK inhibitor trametinib Versus 5-fluorouracil or capecitabine in refractory advanced biliary cancer.,"BACKGROUND


The rationale for the evaluation of trametinib in advanced biliary cancer (BC) is based on the presence of mitogen-activated protein kinase alterations and on earlier promising results with MEK inhibitors in BC.
METHODS


Patients with histologically proven BC who progressed on gemcitabine/platinum were randomised to trametinib daily (arm 1) versus fluoropyrimidine therapy (infusional 5-fluorouracil or oral capecitabine, arm 2). The primary end-point was overall survival (OS). Secondary end-points included progression free survival (PFS) and response rate. A planned interim futility analysis of objective response was performed on the first 14 patients registered to the trametinib arm.
RESULTS


The study was stopped early based on the lack of measurable response in the trametinib arm. A total of 44 eligible patients were randomised (24 patients in arm 1 and 20 patients in arm 2). Median age was 62 years and the primary sites of tumour were cholangiocarcinoma (68%) and gallbladder (32%). The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99) Median OS was 4.3 months for arm 1 and 6.6 months for arm 2. The median PFS was 1.4 months for arm 1 and 3.3 months for arm 2.
CONCLUSIONS


This is the first prospective randomised study of a targeted agent versus chemotherapy for the second-line treatment of BC. In this unselected population, the interim analysis result of unlikely benefit with trametinib resulted in early closure.",2020,The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99),"['refractory advanced biliary cancer', '14 patients registered to the trametinib arm', 'advanced biliary cancer (BC', '44 eligible patients were randomised (24 patients in arm 1 and 20 patients in arm 2', 'Patients with histologically proven BC who progressed on', 'Median age was 62 years and the primary sites of tumour were cholangiocarcinoma (68%) and gallbladder (32']","['single agent MEK inhibitor trametinib Versus 5-fluorouracil or capecitabine', 'fluoropyrimidine therapy (infusional 5-fluorouracil or oral capecitabine, arm 2', 'chemotherapy', 'gemcitabine/platinum']","['overall survival (OS', 'overall response rate', 'median PFS', 'progression free survival (PFS) and response rate', 'Median OS']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",44.0,0.105151,The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99),"[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Kim', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. Electronic address: Richard.Kim@moffitt.org.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McDonough', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Stein', 'Affiliation': 'Rutgers Cancer Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Sahai', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Keogh', 'Affiliation': 'Charleston Hematology Oncology Associates, Southeast COR NCORP, Charleston, SC, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Ari D', 'Initials': 'AD', 'LastName': 'Baron', 'Affiliation': 'California Pacific Medical Center/Sutter Cancer Research Consortium, San Francisco, CA, USA.'}, {'ForeName': 'Abby B', 'Initials': 'AB', 'LastName': 'Siegel', 'Affiliation': 'Columbia University, Columbia MU-NCORP, New York, NY, USA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Javle', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute, New Brunswick, NJ, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.01.026']
294,31320446,"Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide.","OBJECTIVE


To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
RESEARCH DESIGN AND METHODS


EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis). Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.;  n  = 181), placebo ( n  = 37), or liraglutide (≤1.8 mg daily;  n  = 36). The primary efficacy end point was change in HbA 1c  from baseline to week 13.
RESULTS


From a baseline HbA 1c  of 7.7-8.0% (61.0-63.9 mmol/mol), all efpeglenatide doses ≥1 mg significantly reduced HbA 1c  versus placebo (placebo-adjusted least squares [LS] mean changes 0.6-1.2%,  P  < 0.05 for all) to a final HbA 1c  of 6.3-6.8% (45.4-50.6 mmol/mol); masked efpeglenatide 4 mg was noninferior to open-label liraglutide. Greater proportions treated with efpeglenatide ≥1 mg than placebo achieved HbA 1c  <7% (61-72% vs. 24%,  P  < 0.05 for all), and greater reductions in body weight were observed with efpeglenatide 3 and 4 mg versus placebo (placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively,  P <  0.05 for both). Rates of nausea and vomiting were consistent with other GLP-1 RAs and rapidly subsided after the initial 2 weeks. No neutralizing antibodies were detected with efpeglenatide.
CONCLUSIONS


Efpeglenatide once weekly led to significant reductions in HbA 1c  and weight, with a safety profile consistent with the GLP-1 RA class in patients with early T2D mostly on metformin monotherapy.",2019,"(placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively,  P <  0.05 for both).","['early type 2 diabetes (T2D) (drug naive or on metformin monotherapy', 'Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide']","['placebo (placebo-adjusted least squares [LS', 'liraglutide', 'efpeglenatide once weekly referenced to open-label liraglutide', 'placebo', 'glucagon-like peptide 1 receptor agonist (GLP-1 RA', 'metformin monotherapy']","['efficacy, safety, and tolerability', 'change in HbA 1c', 'neutralizing antibodies', 'Rates of nausea and vomiting', 'Glycemic Control and Body Weight', 'body weight']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.1652,"(placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively,  P <  0.05 for both).","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Sorli', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Trautmann', 'Affiliation': 'ProSciento, Chula Vista, CA.'}, {'ForeName': 'Cristóbal', 'Initials': 'C', 'LastName': 'Morales', 'Affiliation': 'Day Hospital & Diabetes Research Unit, Clinical Management Unit Endocrinology and Nutrition, Virgen Macarena University Hospital, Seville, Spain.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Wendisch', 'Affiliation': 'Group Practice in Internal Medicine and Diabetology, Hamburg, Germany.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dailey', 'Affiliation': 'Scripps Clinic, John R. Anderson V Medical Pavilion, La Jolla, CA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Chula Vista, CA.'}, {'ForeName': 'In Young', 'Initials': 'IY', 'LastName': 'Choi', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd., Seoul, South Korea.'}, {'ForeName': 'Jahoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd., Seoul, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi Canada, Laval, Quebec, Canada.'}, {'ForeName': 'Kun-Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': 'The Catholic University of Korea, Seoul, South Korea.'}]",Diabetes care,['10.2337/dc18-2648']
295,31122144,"Pilot study evaluating a non-titrating, weight-based anticoagulation scheme for patients on veno-venous extracorporeal membrane oxygenation.","OBJECTIVE


There is no universally accepted algorithm for anticoagulation in patients on veno-venous extracorporeal membrane oxygenation. The purpose of this pilot study was to compare a non-titrating weight-based heparin infusion to that of a standard titration algorithm.
METHODS


We performed a prospective randomized non-blinded study of patients: Arm 1-standard practice of titrating heparin to activated partial thromboplastin times goal of 45-55 seconds, and Arm 2-a non-titrating weight-based (10 units/kg/h) infusion. Primary outcome was need for oxygenator/circuit changes. Secondary outcomes included differences in hemolysis and bleeding episodes. Descriptive statistics were performed for the continuous data, and primary and secondary outcomes were compared using Fisher's exact test as appropriate.
RESULTS


Six patients were randomized to Arm 1 and four to Arm 2. There was no difference in age, pH, P a O 2 /F i O 2  ratio, peak inspiratory pressure, positive end expiratory pressure, mean airway pressure at time of cannulation, time on extracorporeal membrane oxygenation, or survival to hospital discharge in the two arms. Arm 1 had a statistically higher median activated partial thromboplastin times (48 (43, 52) vs 38 (35, 42), p < 0.008) and lower LDH (808 units/L (727, 1112) vs 940 units/L (809, 1137), p = 0.02) than Arm 2. There was no difference in plasma hemoglobin (4.3 (2.5, 8.7) vs 4.3 (3.0, 7.3), p = 0.65) between the two arms. There was no difference in mean oxygenator/circuit change, transfused packed red blood cell, or documented bleeding complications per patient in each arm (p = 0.56, 0.43, 0.77, respectively).
CONCLUSION


In this pilot study, a non-titrating, weight-based heparin infusion appears safe and as effective in preventing veno-venous extracorporeal membrane oxygenation circuit thrombotic complications as compared to a titration algorithm. Larger studies are needed to confirm these preliminary findings.",2020,"There was no difference in age, pH, P a O 2","['Six patients', 'patients on veno-venous extracorporeal membrane oxygenation', 'patients']","['F', 'titrating heparin to activated partial thromboplastin times goal of 45-55\u2009seconds, and Arm 2-a non-titrating weight-based (10\u2009units/kg/h) infusion', 'heparin', 'heparin infusion']","['mean oxygenator/circuit change, transfused packed red blood cell, or documented bleeding complications', 'hemolysis and bleeding episodes', 'i O 2  ratio, peak inspiratory pressure, positive end expiratory pressure', 'need for oxygenator/circuit changes', 'median activated partial thromboplastin times', 'mean airway pressure at time of cannulation, time on extracorporeal membrane oxygenation, or survival to hospital discharge', 'plasma hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030067', 'cui_str': 'Oxygenators'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",6.0,0.174072,"There was no difference in age, pH, P a O 2","[{'ForeName': 'Kristopher B', 'Initials': 'KB', 'LastName': 'Deatrick', 'Affiliation': 'Department of Surgery, School of Medicine, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Galvagno', 'Affiliation': 'Department of Anesthesia, School of Medicine, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Mazzeffi', 'Affiliation': 'Department of Anesthesia, School of Medicine, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kaczoroswki', 'Affiliation': 'Department of Surgery, School of Medicine, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Herr', 'Affiliation': 'Program in Trauma, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Rector', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Rabinowitz', 'Affiliation': 'Program in Trauma, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Scalea', 'Affiliation': 'Department of Surgery, School of Medicine, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Menaker', 'Affiliation': 'Department of Surgery, School of Medicine, University of Maryland, Baltimore, MD, USA.'}]",Perfusion,['10.1177/0267659119850024']
296,31408838,APOE gene-dependent BOLD responses to a breath-hold across the adult lifespan.,"Age and apolipoprotein E (APOE) e4 genotype are two of the strongest known risk factors for sporadic Alzheimer's disease (AD). Neuroimaging has shown hemodynamic response changes with age, in asymptomatic carriers of the APOE e4 allele, and in AD. In this study, we aimed to characterize and differentiate age- and APOE gene-specific hemodynamic changes to breath-hold and visual stimulation. A further aim was to study whether these responses were modulated by 3-day intake of nitrate, a nitric oxide (NO) source. The study was designed as a randomized, double-blinded, placebo-controlled crossover study, and the study cohort comprised 41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70 years at enrollment. The participants underwent two scanning sessions, each preceded by ingestion of sodium nitrate or sodium chloride (control). During functional magnetic resonance imaging (fMRI) sessions, participants performed two concurrent tasks; a breath-hold task to probe cerebrovascular reactivity and a visual stimulation task to evoke functional hyperemia, respectively. We found that the blood oxygenation level dependent (BOLD) hemodynamic response to breath-hold was altered in APOE e4 carriers relative to non-carriers. Mid-aged (50-60 years of age) e4 carriers exhibited a significantly increased peak time relative to mid-aged e3 carriers, and peak time for younger (30-40 years of age) e4 carriers was significantly shorter than that of mid-aged e4 carriers. The response width was significantly increased for e4 carriers. The response peak magnitude significantly decreased with age. For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type. We found no effect of nitrate ingestion on BOLD responses evoked by the breath-hold and visual stimulation tasks. The APOE gene-dependent response to breath-hold may reflect NO-independent differences in vascular function.",2019,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.",['41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70\u202fyears at enrollment'],"['sodium nitrate or sodium chloride (control', 'placebo', 'functional magnetic resonance imaging (fMRI) sessions', 'nitrate ingestion']","['response peak magnitude', 'blood oxygenation level dependent (BOLD) hemodynamic response', 'peak time relative', 'response width', 'Age and apolipoprotein E (APOE']","[{'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0523511', 'cui_str': 'Apolipoproteins E measurement (procedure)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",,0.218788,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rasmussen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: pmr@cfin.au.dk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Aamand', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christiansen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben E', 'Initials': 'TE', 'LastName': 'Lund', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101955']
297,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
298,32251012,The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study.,"OBJECTIVES


This work describes the development of a manualized best-practice hearing intervention for older adults participating in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized controlled clinical trial. Manualization of interventions for clinical trials is critical for assuring intervention fidelity and quality, especially in large multisite studies. The multisite ACHIEVE randomized controlled trial is designed to assess the efficacy of a hearing intervention on rates of cognitive decline in older adults. We describe the development of the manualized hearing intervention through an iterative process that included addressing implementation questions through the completion of a feasibility study (ACHIEVE-Feasibility).
DESIGN


Following published recommendations for manualized intervention development, an iterative process was used to define the ACHIEVE-hearing intervention elements and create an initial manual. The intervention was then delivered within the ACHIEVE-Feasibility study using one-group pre-post design appropriate for assessing questions related to implementation. Participants were recruited from the Tampa, Florida area between May 2015 and April 2016. Inclusion criteria were cognitively healthy adults aged 70 to 89 with symmetrical mild-to-moderately severe sensorineural hearing loss. The ACHIEVE-Feasibility study sought to assess the implementation of the manualized hearing intervention by: (1) confirming improvement in expected outcomes were achieved including aided speech-in-noise performance and perception of disease-specific self-report measures; (2) determining whether the participants would comply with the intervention including session attendance and use of hearing aids; and (3) determining whether the intervention sessions could be delivered within a reasonable timeframe.
RESULTS


The initial manualized intervention that incorporated the identified best-practice elements was evaluated for feasibility among 21 eligible participants and 9 communication partners. Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap. Compliance was excellent, with 20 of the 21 participants (95.2%) completing all intervention sessions and 19 (90.4%) returning for the 6-month post-intervention visit. Furthermore, self-reported hearing aid compliance was >8 hr/day, and the average daily hearing aid use from datalogging was 7.8 hr. Study completion was delivered in a reasonable timeframe with visits ranging from 27 to 85 min per visit. Through an iterative process, the intervention elements were refined, and the accompanying manual was revised based on the ACHIEVE-Feasibility study activities, results, and clinician and participant informal feedback.
CONCLUSION


The processes for the development of a manualized intervention described here provide guidance for future researchers who aim to examine the efficacy of approaches for the treatment of hearing loss in a clinical trial. The manualized ACHIEVE-Hearing Intervention provides a patient-centered, yet standardized, step-by-step process for comprehensive audiological assessment, goal setting, and treatment through the use of hearing aids, other hearing assistive technologies, counseling, and education aimed at supporting self-management of hearing loss. The ACHIEVE-Hearing Intervention is feasible in terms of implementation with respect to verified expected outcomes, compliance, and reasonable timeframe delivery. Our processes assure intervention fidelity and quality for use in the ACHIEVE randomized controlled trial (ClinicalTrials.gov Identifier: NCT03243422).",2020,Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap.,"['Inclusion criteria were cognitively healthy adults aged 70 to 89 with symmetrical mild-to-moderately severe sensorineural hearing loss', '21 eligible participants and 9 communication partners', 'older adults', 'older adults participating in the Aging and Cognitive Health Evaluation in Elders', 'Participants were recruited from the Tampa, Florida area between May 2015 and April 2016']","['manualized best-practice hearing intervention', 'hearing intervention', 'manualized hearing intervention', 'Hearing Intervention', 'hearing aids, other hearing assistive technologies, counseling, and education aimed at supporting self-management of hearing loss']","['rates of cognitive decline', 'self-perceived hearing handicap']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}]",21.0,0.0348221,Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap.,"[{'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Sanchez', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of South Florida, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Arnold', 'Affiliation': 'College of Math, University of South Florida-Sarasota-Manatee, USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Reed', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, USA.'}, {'ForeName': 'Preyanca H', 'Initials': 'PH', 'LastName': 'Oree', 'Affiliation': 'Department of Communication Sciences and Disorder, University of South Florida, USA.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Matthews', 'Affiliation': 'Charlotte Eye Ear Nose and Throat Associates, PA, North Carolina, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Clock Eddins', 'Affiliation': 'Department of Communication Sciences and Disorder, University of South Florida, USA.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, USA.'}, {'ForeName': 'Theresa H', 'Initials': 'TH', 'LastName': 'Chisolm', 'Affiliation': 'Department of Communication Sciences and Disorder, University of South Florida, USA.'}]",Ear and hearing,['10.1097/AUD.0000000000000858']
299,31795041,Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.,"Real-time functional magnetic resonance imaging (fMRI) neurofeedback training of amygdala hemodynamic activity directly targets a neurobiological mechanism, which contributes to emotion regulation problems in borderline personality disorder (BPD). However, it remains unknown which outcome measures can assess changes in emotion regulation and affective instability, associated with amygdala downregulation in a clinical trial. The current study directly addresses this question. Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback. Before and after the training, as well as at a six-weeks follow-up assessment, participants completed measures of emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI). Participants were able to downregulate their amygdala blood oxygen-dependent (BOLD) response with neurofeedback. There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training. Further explorative analyses suggest that patients indicated less affective instability, as seen by lower hour-to-hour variability in negative affect and inner tension in daily life. If replicated by an independent study, our results imply changes in emotion regulation and affective instability for several systems levels, including behavior and verbal report. Conclusions are limited due to the lack of a control group. A randomized controlled trial (RCT) will be needed to confirm effectiveness of the training.",2019,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"['patients with borderline personality disorder', 'borderline personality disorder (BPD', 'Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback']",[],"['emotion-modulated startle to negative pictures', 'emotion regulation and affective instability', 'amygdala blood oxygen-dependent (BOLD) response with neurofeedback', 'affective instability', 'emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI', 'emotion regulation', 'Zanarini rating scale for BPD (ZAN-BPD', 'BPD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.0423346,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zaehringer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany. Electronic address: jenny.zaehringer@zi-mannheim.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ende', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Santangelo', 'Affiliation': 'Chair of Applied Psychology/Mental Health Lab, Institute of Sport and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ruf', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department for General Psychiatry, Center of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany; Sagol Brain Institute, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: christian.paret@zi-mannheim.de.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102032']
300,32210268,Scrambled body differentiates body part ownership from the full body illusion.,"Illusory body ownership can be induced in a body part or a full body by visual-motor synchronisation. A previous study indicated that an invisible full body illusion can be induced by the synchronous movement of only the hands and feet. The difference between body part ownership and the full body illusion has not been explained in detail because there is no method for separating these two illusions. To develop a method to do so, we scrambled or randomised the positions of the hands and feet and compared it with the normal layout stimulus by manipulating visual-motor synchronisation. In Experiment 1, participants observed the stimuli from a third-person perspective, and the questionnaire results showed that the scrambled body stimulus induced only body part ownership, while the normal layout stimulus induced both body part ownership and full body ownership when the stimuli were synchronous with participants' actions. In Experiment 2, we found similar results as with the first-person perspective stimuli in a questionnaire. We did not find significant skin conductance response difference between any conditions in either Experiment 2 or 3. These results suggest that a spatial relationship is necessary for the full body illusion, but not for body part ownership.",2020,We did not find significant skin conductance response difference between any conditions in either Experiment 2 or 3.,[],[],['skin conductance response difference'],[],[],"[{'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0133231,We did not find significant skin conductance response difference between any conditions in either Experiment 2 or 3.,"[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kondo', 'Affiliation': 'Department of Computer Science and Engineering, Toyohashi University of Technology, 1-1 Hibarigaoka, Tempaku, Toyohashi, Aichi, 441-8580, Japan. kondo@real.cs.tut.ac.jp.'}, {'ForeName': 'Yamato', 'Initials': 'Y', 'LastName': 'Tani', 'Affiliation': 'Department of Computer Science and Engineering, Toyohashi University of Technology, 1-1 Hibarigaoka, Tempaku, Toyohashi, Aichi, 441-8580, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Information and Computer Science, Keio University, 3-14-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa, 223-8522, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Inami', 'Affiliation': 'Research Center for Advanced Science and Technology, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Michiteru', 'Initials': 'M', 'LastName': 'Kitazaki', 'Affiliation': 'Department of Computer Science and Engineering, Toyohashi University of Technology, 1-1 Hibarigaoka, Tempaku, Toyohashi, Aichi, 441-8580, Japan.'}]",Scientific reports,['10.1038/s41598-020-62121-9']
301,32210340,Longitudinal Study of Body Composition and Energy Expenditure in Overweight or Obese Young Adults.,"The aim of this study was to compare the effects of an aerobic training program with a strength training program on body composition and energy expenditure in overweight or obese (29.06 ± 3.49 kg/m 2 ) young adults (21.96 ± 1.90 years). Subjects (N = 109) were randomly assigned to one of three groups: a control group (CG), an aerobic training (AT) group and a strength training (ST) group. Training took place over twelve weeks comprising three sessions per week with each session lasting 60 to 90 minutes. Before and after the program, weight, height, body mass index, lean mass percentage and fat mass percentage were evaluated. In addition, The International Physical Activity Questionnaire-Short Form (IPAQ-SF) was used to estimate energy expenditure. The results of both aerobic training and strength training produced statistically significant improvements in weight (AT-CG = -2.892 kg; ST-CG = -2.986 kg); BMI (AT-CG = -1.075 kg/m 2 ; ST-CG = -1.118 kg/m 2 ); total body fat (AT-CG = -1529.172 g; ST-CG = -763.815); and total body fat percentage (AT-CG = -1.421%; AT-ST = -0.855%). These two exercise prescription models were therefore useful in reducing overweight and obesity, which could have an impact on improving the health and quality of life of individuals with these characteristics.",2020,The results of both aerobic training and strength training produced statistically significant improvements in weight (AT-CG = -2.892 kg; ST-CG = -2.986 kg); BMI (AT-CG = -1.075 kg/m 2 ; ST-CG = -1.118 kg/m 2 ); total body fat (AT-CG = -1529.172 g; ST-CG = -763.815); and total body fat percentage (AT-CG = -1.421%; AT-ST = -0.855%).,"['Overweight or Obese Young Adults', 'Subjects (N\u2009=\u2009109', 'overweight or obese (29.06\u2009±\u20093.49\u2009kg/m 2 ) young adults (21.96\u2009±\u20091.90 years']","['aerobic training and strength training', 'aerobic training program', 'Body Composition and Energy Expenditure', 'control group (CG), an aerobic training (AT) group and a strength training (ST', 'strength training program']","['total body fat', 'weight', 'total body fat percentage', 'International Physical Activity Questionnaire-Short Form (IPAQ-SF', 'body composition and energy expenditure']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}]",109.0,0.0147166,The results of both aerobic training and strength training produced statistically significant improvements in weight (AT-CG = -2.892 kg; ST-CG = -2.986 kg); BMI (AT-CG = -1.075 kg/m 2 ; ST-CG = -1.118 kg/m 2 ); total body fat (AT-CG = -1529.172 g; ST-CG = -763.815); and total body fat percentage (AT-CG = -1.421%; AT-ST = -0.855%).,"[{'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'Department of Didactics of Languages, Arts and Sport, University of Malaga, Andalucía-Tech, Malaga, Spain, IBIMA, Malaga, Spain.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Gálvez-Fernández', 'Affiliation': 'Department of Didactics of Languages, Arts and Sport, University of Malaga, Andalucía-Tech, Malaga, Spain, IBIMA, Malaga, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Mercadé-Melé', 'Affiliation': 'Department of Statistics and Econometrics, University of Malaga, Andalucía-Tech, Malaga, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gavala-González', 'Affiliation': 'Department of Physical Education and Sports, University of Seville, Seville, Spain. jgavala@us.es.'}]",Scientific reports,['10.1038/s41598-020-62249-8']
302,31670070,Evidence for decreased Neurologic Pain Signature activation following thoracic spinal manipulation in healthy volunteers and participants with neck pain.,"BACKGROUND CONTEXT


Spinal manipulation (SM) is a common treatment for neck and back pain, theorized to mechanically affect the spine leading to therapeutic mechanical changes. The link between specific mechanical effects and clinical improvement is not well supported. SM's therapeutic action may instead be partially mediated within the central nervous system.
PURPOSE


To introduce brain-based models of pain for spinal pain and manual therapy research, characterize the distributed central mechanisms of SM, and advance the preliminary validation of brain-based models as potential clinical biomarkers of pain.
STUDY DESIGN


Secondary analysis of two functional magnetic resonance imaging studies investigating the effect of thoracic SM on pain-related brain activity: A non-controlled, non-blinded study in healthy volunteers (Study 1, n = 10, 5 females, and mean age = 31.2 ± 10.0 years) and a randomized controlled study in participants with acute to subacute neck pain (Study 2, n = 24, 16 females, mean age = 38.0 ± 15.1 years).
METHODS


Functional magnetic resonance imaging was performed during noxious mechanical stimulation of the right index finger cuticle pre- and post-intervention. The effect of SM on pain-related activity was studied within brain regions defined by the Neurologic Pain Signature (NPS) that are predictive of physical pain.
RESULTS


In Study 1, evoked mechanical pain (p < 0.001) and NPS activation (p = 0.010) decreased following SM, and the changes in evoked pain and NPS activation were correlated (r RM 2  = 0.418, p = 0.016). Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019). In Study 2, neck pain (p = 0.046) and NPS (p = 0.033) activation decreased following verum but not sham SM. Associations between evoked pain, neck pain, and NPS activation, were not significant and less clear, possibly due to inadequate power, methodological limitations, or other confounding factors.
CONCLUSIONS


The findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.",2019,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","['healthy volunteers (Study 1, n\u202f=\u202f10, 5 females, and mean age\u202f=\u202f31.2\u202f±\u202f10.0 years', 'participants with acute to subacute neck pain (Study 2, n\u202f=\u202f24, 16 females, mean age\u202f=\u202f38.0\u202f±\u202f15.1 years', 'healthy volunteers and participants with neck pain']","['SM', 'thoracic SM', 'thoracic spinal manipulation']","['dACC activity', 'evoked mechanical pain', 'NPS activation', 'pain-related activity', 'Neurologic Pain Signature activation', 'evoked pain and NPS activation', 'NPS', 'SM, and evoked pain', 'neck pain', 'evoked pain, neck pain, and NPS activation', 'pain-related brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",,0.0871702,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States. Electronic address: kenweber@stanford.edu.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Psychology and Neuroscience, Center for Neuroscience, Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Elliott', 'Affiliation': 'Northern Sydney Local Health District, The Kolling Research Institute and The Faculty of Health Sciences, The University of Sydney, St. Leonards, NSW, Australia.'}, {'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Center for Collaborative Brain Research, Department of Radiology, OSF HealthCare Saint Francis Medical Center, Peoria, IL, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Sparks', 'Affiliation': 'Center of Expertise, Rehabilitation and Occupational Health, OSF HealthCare, Peoria, IL, United States; School of Physical Therapy, South College, Knoxville, TN, United States.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102042']
303,32251265,Blood-based biomarkers for prediction of intracranial hemorrhage and outcome in patients with moderate or severe traumatic brain injury.,"BACKGROUND


Early identification of traumatic intracranial hemorrhage (ICH) has implications for triage and intervention. Blood-based biomarkers were recently approved by the Food and Drug Administration (FDA) for prediction of ICH in patients with mild traumatic brain injury (TBI). We sought to determine if biomarkers measured early after injury improve prediction of mortality and clinical/radiologic outcomes compared with Glasgow Coma Scale (GCS) alone in patients with moderate or severe TBI (MS-TBI).
METHODS


We measured glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), and microtubule-associated protein-2 (MAP-2) on arrival to the emergency department (ED) in patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS score, 3-12; SPB, > 90). Biomarkers were modeled individually and together with prehospital predictor variables [PH] (GCS score, age, sex). Data were divided into a training data set and test data set for model derivation and evaluation. Models were evaluated for prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended (GOS-E) and Disability Rating Scale (DRS). Area under the curve (AUC) was evaluated in test data for PH alone, PH + individual biomarkers, and PH + three biomarkers.
RESULTS


Of 243 patients with baseline samples (obtained a median of 84 minutes after injury), prehospital GCS score was 8 (interquartile range, 5-10), 55% had ICH, and 48-hour and 28-day mortality were 7% and 13%, respectively. Poor neurologic outcome at 6 months was observed in 34% based on GOS-E of 4 or less, and 24% based on DRS greater than or equal to7. Addition of each biomarker to PH improved AUC in the majority of predictive models. GFAP+PH compared with PH alone significantly improved AUC in all models (ICH, 0.82 vs. 0.64; 48-hour mortality, 0.84 vs. 0.71; 28-day mortality, 0.84 vs. 0.66; GOS-E, 0.78 vs. 0.69; DRS, 0.84 vs. 0.81, all p < 0.001).
CONCLUSION


Circulating blood-based biomarkers may improve prediction of neurological outcomes and mortality in patients with MS-TBI over prehospital characteristics alone. Glial fibrillary acidic protein appears to be the most promising. Future evaluation in the prehospital setting is warranted.
LEVEL OF EVIDENCE


Prospective, Prognostic and Epidemiological, level II.",2020,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001].
","['patients with mild TBI', 'traumatic intracranial hemorrhage (ICH', '243 patients with baseline samples', 'patients with moderate or severe TBI (MS-TBI', 'patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS 3-12, SPB > 90', 'patients with MS-TBI over prehospital characteristics alone']","['GCS', 'GFAP', 'GFAP+PH']","['AUC', 'prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended [GOSE] and Disability Rating Scale [DRS', 'Poor neurologic outcome', 'glial-fibrillary-acidic-protein (GFAP), ubiquitin-C-terminal-hydrolase-L1 (UCH-L1), and microtubule-associated-protein-2 (MAP-2', 'prehospital GCS', 'mortality and clinical/radiologic outcomes', 'ICH, and 48-hr and 28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0273058', 'cui_str': 'Intracranial hemorrhage following injury'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0597729', 'cui_str': 'Spindle Pole Body'}, {'cui': 'C0439083', 'cui_str': '>90'}]","[{'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0451125', 'cui_str': 'Disability rating scale'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0164005', 'cui_str': 'Ubiquitin thiolesterase'}, {'cui': 'C1436157', 'cui_str': 'UCHL1 protein, human'}, {'cui': 'C0024773', 'cui_str': 'MAP2 Microtubule-Associated Protein'}, {'cui': 'C1433609', 'cui_str': 'METAP2 protein, human'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}]",243.0,0.0609947,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001].
","[{'ForeName': 'Taylor N', 'Initials': 'TN', 'LastName': 'Anderson', 'Affiliation': 'From the School of Medicine (T.N.A.), Department of Neurology (H.E.H.), Department of Surgery (S.E.R.), Oregon Health and Science University, Portland, Oregon; Department of Biostatistics (J.H.), University of Washington, Seattle, Washington; College of Pharmacy (M.M.), Oregon State University, Corvallis, Oregon; Department of Emergency Medicine (L.P.), Orlando Regional Medical Center, Orlando, Florida; Department of Surgery (A.V.), Mercer University School of Medicine, Macon, Georgia; and Department of Surgery (S.E.R.), Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Munar', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vaughan', 'Affiliation': ''}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002706']
304,32035516,"Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial.","BACKGROUND


The RV144 phase 3 vaccine trial in Thailand demonstrated that ALVAC-HIV (vCP1521) and AIDSVAX B/E administration over 6 months resulted in a 31% efficacy in preventing HIV acquisition. In this trial, we assessed the immunological effect of an additional vaccine boost to the RV144 regimen at varying intervals between the priming vaccine series and the boost.
METHODS


RV306 is a double-blind, placebo-controlled, randomised clinical trial done at three clinical sites in Thailand. Eligible volunteers were HIV-uninfected individuals aged 20-40 years who were at low risk for HIV infection and in good health. A randomisation schedule was centrally generated with fixed sized strata for Research Institute for Health Sciences Chiang Mai and combined Bangkok clinics. Participants were randomly assigned to one of five groups and then further randomly assigned to either vaccine or placebo. All participants received the primary RV144 vaccine series at months 0, 1, 3, and 6. Group 1 received no additional boost, group 2 received additional AIDSVAX B/E and ALVAC-HIV (vCP1521) or placebo at month 12, group 3 received AIDSVAX B/E alone or placebo at month 12, group 4a received AIDSVAX B/E and ALVAC-HIV or placebo at month 15, and group 4b received AIDSVAX B/E and ALVAC-HIV or placebo at month 18. Primary outcomes were safety and tolerability of these vaccination regimens and cellular and humoral immune responses compared between the RV144 series alone and regimens with late boosts at different timepoints. Safety and tolerability outcomes were assessed by evaluating local and systemic reactogenicity and adverse events in all participants. This trial is registered at ClinicalTrials.gov (NCT01931358); clinical follow-up is now complete.
FINDINGS


Between Oct 28, 2013, and April 29, 2014, 367 participants were enrolled, of whom 27 were assigned active vaccination in group 1, 102 in group 2, 101 in group 3, 52 in group 4a, 51 in group 4b, and 34 combined placebo across all the groups. No vaccine-related serious adverse events were recorded. Occurrence and severity of local and systemic reactogenicity were similar across active groups. Groups with late boosts (groups 2, 3, 4a, and 4b) had increased peak plasma IgG-binding antibody levels against gp70 V1V2 relative to group 1 vaccine recipients with no late boost (gp70 V1V2 92TH023 adjusted p<0·02 for each; gp70 V1V2 CaseA2 adjusted p<0·0001 for each). Boosting at month 12 (groups 2 and 3) did not increase gp120 responses compared with the peak responses after the RV144 priming regimen at month 6; however, boosting at month 15 (group 4a) improved responses to gp120 A244gD- D11 (p=0·0003), and boosting at month 18 (group 4b) improved responses to both gp120 A244gD- D11 (p<0·0001) and gp120 MNgD- D11 (p=0·0016). Plasma IgG responses were significantly lower among vaccine recipients boosted at month 12 (pooled groups 2 + 3) than at month 15 (group 4a; adjusted p<0·0001 for each, except for gp70 V1V2 CaseA2, p=0·0142) and at month 18 (group 4b; all adjusted p<0·001). Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens. CD4 functionality and polyfunctionality scores after stimulation with HIV-1 Env peptides (92TH023) increased with delayed boosting. Groups with late boosts had increased functionality and polyfunctionality scores relative to vaccine recipients with no late boost (all adjusted p<0·05, except for the polyfunctionality score in group 1 vs group 4b, p<0·01).
INTERPRETATION


Taken together, these results suggest that additional boosting of the RV144 regimen with longer intervals between the primary vaccination series and late boost improved immune responses and might improve the efficacy of preventing HIV acquisition.
FUNDING


US National Institute of Allergy and Infectious Diseases and US Department of the Army.",2020,Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens.,"['Eligible volunteers were HIV-uninfected individuals aged 20-40 years who were at low risk for HIV infection and in good health', 'HIV-uninfected Thai volunteers', 'Between Oct 28, 2013, and April 29, 2014, 367 participants were enrolled, of whom 27 were assigned']","['AIDSVAX B/E and ALVAC-HIV or placebo', 'vaccine or placebo', 'placebo', 'additional AIDSVAX B/E and ALVAC-HIV (vCP1521) or placebo', 'AIDSVAX B/E alone or placebo', 'AIDSVAX B/E and ALVAC-HIV', 'MNgD', 'active vaccination']","['CD4 functionality and polyfunctionality scores', 'safety and tolerability of these vaccination regimens and cellular and humoral immune responses', 'peak plasma IgG-binding antibody levels against gp70 V1V2 relative', 'functionality and polyfunctionality scores', 'Plasma IgG responses', 'Occurrence and severity of local and systemic reactogenicity', 'local and systemic reactogenicity and adverse events', 'Safety and tolerability outcomes', 'plasma IgG response']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1155229'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",367.0,0.327131,Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens.,"[{'ForeName': 'Punnee', 'Initials': 'P', 'LastName': 'Pitisuttithum', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sorachai', 'Initials': 'S', 'LastName': 'Nitayaphan', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Suwat', 'Initials': 'S', 'LastName': 'Chariyalertsak', 'Affiliation': 'Research Institute for Health Sciences and Faculty of Public Health, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jaranit', 'Initials': 'J', 'LastName': 'Kaewkungwal', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Dhitavat', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjaluck', 'Initials': 'B', 'LastName': 'Phonrat', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Siriwat', 'Initials': 'S', 'LastName': 'Akapirat', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Karasavvas', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Wieczorek', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Polonis', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Pegu', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schuetz', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Surat', 'Initials': 'S', 'LastName': 'Jongrakthaitae', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Sinangil', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA; GlaxoSmithKline, Siena, Italy.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Diazgranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tartaglia', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Heger', 'Affiliation': 'US Army Medical Materiel Development Activity, Fort Detrick, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; International Vaccine Institute, Seoul, South Korea.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; International Vaccine Institute, Seoul, South Korea.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': ""O'Connell"", 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Vasan', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. Electronic address: svasan@hivresearch.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30406-0']
305,32167712,Modified wallace anastomotic technique reduces ureteroenteric stricture rates after ileal conduit urinary diversion.,"PURPOSE


To compare perioperative outcomes, complications and anastomotic stricture rate in a contemporary series of patients who underwent open radical cystectomy (RC) with modified Wallace anastomotic technique versus traditional ileal conduit.
MATERIALS AND METHODS


Study enrolled 180 patients, of whom 140 were randomized and underwent RC; seventy were randomized to group I and the seventy to the group II. For the primary objective, we hypothesized that the rate of ureteroenteric strictures would be at least 20 % lower in the second group. Secondary end points included rate of anastomotic leak, surgical time, deterioration of the upper tract, intraoperative blood loss and patient-reported quality of life (HRQOL). The modified Wallace 1 technique involved eversion of the ureteral plate and bowel mucosa edges, which were anastomosed together in running fashion, while the outher anastomotic wall was augmented with sero-serosal interrupted sutures.
RESULTS


The mean (SD) follow-up time was 26.1 (5.7) months in group I and 25.2 (4.8) months in group II, during which, anastomotic stricture was observed in 8 patients (12%) from the first and 2 patients (3%) from the second group (p < 0.05). The anastomotic leakage rate was significantly higher in first group (17% vs. 8.5%, p < 0.05), while patient-reported HRQOL outcomes were similar between groups after the 12 month follow-up period.
CONCLUSIONS


By using a modified Wallace technique, we were able to significantly lower anastomotic stricture and anastomotic leakage rates, which are major issues in minimizing both short- and long-term postoperative complications.",2020,"The anastomotic leakage rate was significantly higher in first group (17% vs. 8.5%, p < 0.05), while patient-reported HRQOL outcomes were similar between groups after the 12 month follow-up period.
","['Study enrolled 180 patients, of whom 140 were randomized and underwent RC; seventy were randomized to group', 'ileal conduit urinary diversion', 'patients who underwent']","['modified Wallace technique', 'open radical cystectomy (RC) with modified Wallace anastomotic technique versus traditional ileal conduit', 'Modified wallace anastomotic technique']","['anastomotic stricture', 'HRQOL outcomes', 'anastomotic stricture and anastomotic leakage rates', 'anastomotic leakage rate', 'perioperative outcomes, complications and anastomotic stricture rate', 'ureteroenteric stricture rates', 'rate of ureteroenteric strictures', 'rate of anastomotic leak, surgical time, deterioration of the upper tract, intraoperative blood loss and patient-reported quality of life (HRQOL', 'mean (SD) follow-up time']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}, {'cui': 'C0042020', 'cui_str': 'Urinary Diversion'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}]","[{'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",180.0,0.0405474,"The anastomotic leakage rate was significantly higher in first group (17% vs. 8.5%, p < 0.05), while patient-reported HRQOL outcomes were similar between groups after the 12 month follow-up period.
","[{'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Kavaric', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Sabovic', 'Initials': 'S', 'LastName': 'Eldin', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Radovic', 'Initials': 'R', 'LastName': 'Nenad', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Pratljacic', 'Initials': 'P', 'LastName': 'Dragan', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Vukovic', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0417']
306,32124977,Transcutaneous electrical nerve stimulation (TENS) for pain management in sickle cell disease.,"BACKGROUND


Sickle cell disease (SCD), one of the most common inherited disorders, is associated with vaso-occlusive pain episodes and haemolysis leading to recurrent morbidity, hospital admissions and work or school absenteeism. The crises are conventionally treated with opioids, non-opioids and other adjuvants with the risk of developing complications, addictions and drug-seeking behaviour. Different non-pharmacological treatments, such as transcutaneous electrical nerve stimulation (TENS) have been used for managing pain in other painful conditions. Hence, the efficacy of TENS for managing pain in SCD needs to be reviewed.
OBJECTIVES


To assess the benefits and harms of TENS for managing pain in people with SCD who experience pain crises or chronic pain (or both).
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries and the reference lists of relevant articles and reviews. Date of the last search: 26 Febraury 2020.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) and quasi-RCTs, where TENS was evaluated for managing pain in people with SCD.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed the eligibility of the trials identified by the literature searches according to the inclusion criteria. Two review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using the GRADE guidelines.
MAIN RESULTS


One double-blind cross-over RCT with 22 participants with SCD (aged 12 to 27 years) was eligible for inclusion. Following stratification into four pain crises severity grades, participants were then randomised to receive TENS or placebo (sham TENS). The trial was concluded after 60 treatment episodes (30 treatment episodes of each treatment group). There is a lack of clarity regarding the trial design and the analysis of the cross-over data. If a participant was allocated to TENS treatment for an episode of pain and subsequently returned with a further episode of a similar degree of pain, they would then receive the sham TENS treatment (cross-over design). For those experiencing a pain episode of a different severity, it is not clear whether they were re-randomised or given the alternate treatment. Reporting and analysis was based on the total number pain events and not on the number of participants. It is unclear how many participants were crossed over from the TENS group to the sham TENS group and vice versa. The trial had a high risk of bias regarding random sequence generation and allocation concealment; an unclear risk regarding the blinding of participants and personnel; and a low risk regarding the blinding of the outcome assessors and selective outcome reporting. The trial was small and of very low quality; furthermore, given the issue with trial design we were unable to quantitatively analyse the data. Therefore, we present only a narrative summary and caution is advised in interpreting the results. In relation to our pre-defined primary outcomes, the included trial did not report pain relief at two to four weeks post intervention. The trial authors reported that no difference was found in the changes in pain ratings (recorded at one hour and four hours post intervention) between the TENS and the placebo groups. In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups. Given the quality of the evidence, we are uncertain whether TENS improves overall satisfaction as compared to sham TENS. The ability to cope with activities of daily living was not evaluated. Regarding adverse events, although one case of itching was reported in the TENS group, the site and nature of itching was not clearly stated; hence it cannot be clearly attributed to TENS. Also, two participants receiving 'sham' TENS reported a worsening of pain with the intervention.
AUTHORS' CONCLUSIONS


Since we have only included one small and very low-quality trial, with a high risk of bias across several domains, we are unable to conclude whether TENS is harmful or beneficial for managing pain in people with SCD. There is a need for a well-designed, adequately-powered, RCT to evaluate the role of TENS in managing pain in people with SCD.",2020,"In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups.","['22 participants with SCD (aged 12 to 27 years) was eligible for inclusion', 'people with SCD who experience pain crises or chronic pain (or both', 'people with SCD', 'pain management in sickle cell disease']","['TENS or placebo (sham TENS', 'Transcutaneous electrical nerve stimulation (TENS', 'transcutaneous electrical nerve stimulation (TENS', 'TENS']","['total number pain events', 'pain relief', 'pain ratings', 'overall satisfaction', 'analgesic usage', 'worsening of pain']","[{'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis (finding)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}]","[{'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",22.0,0.348723,"In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups.","[{'ForeName': 'Sudipta', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'Melaka-Manipal Medical College (Manipal Academy of Higher Education), Department of Community Medicine, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Ruchita', 'Initials': 'R', 'LastName': 'Dixit', 'Affiliation': 'Melaka-Manipal Medical College (Manipal Academy of Higher Education), Department of Community Medicine, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Soe', 'Initials': 'S', 'LastName': 'Moe', 'Affiliation': 'Melaka-Manipal Medical College (Manipal Academy of Higher Education), Department of Community Medicine, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Myron Anthony', 'Initials': 'MA', 'LastName': 'Godinho', 'Affiliation': 'University of New South Wales, School of Public Health and Community Medicine, Kensington, NSW, Australia, 2052.'}, {'ForeName': 'Adinegara Bl', 'Initials': 'AB', 'LastName': 'Abas', 'Affiliation': 'Melaka-Manipal Medical College (Manipal Academy of Higher Education), Department of Community Medicine, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Ballas', 'Affiliation': 'Jefferson Medical College, Thomas Jefferson University, Cardeza Foundation for Hematologic Research, Department of Medicine, 1015 Walnut Street, Philadelphia, PA, USA, 19107-5099.'}, {'ForeName': 'Shanker', 'Initials': 'S', 'LastName': 'Ram', 'Affiliation': 'Melaka-Manipal Medical College (Manipal Academy of Higher Education), Department of Psychiatry, Jalan Batu Hampar, Bukit Baru, Melaka, Melaka, Malaysia, 75150.'}, {'ForeName': 'Uduman Ali M', 'Initials': 'UAM', 'LastName': 'Yousuf', 'Affiliation': 'Melaka-Manipal Medical College (Manipal Academy of Higher Education), Department of Medicine, Jalan Batu Hampar, Bukit Baru, Melaka, Melaka, Malaysia, 75150.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012762.pub2']
307,31762185,The effect on pregnant women's prenatal attachment of a nursing practice using the first and second Leopold's maneuvers.,"OBJECTIVE


This study aimed to determine the effect on pregnant women's prenatal attachment of a nursing practice using the first and second Leopold's maneuvers.
METHOD


This experimental, randomized and controlled study was conducted in a pregnancy class of a training and research hospital in Kocaeli, Turkey from September 2016 to September 2017. Its sample included 100 pregnant women, 50 in the experimental group and 50 in the control group (https://www.random.org, accessed: 09.20.2016). Data were collected using a personal information form, the Prenatal Attachment Inventory (PAI) and the Fetal Position Awareness Scale (FPAS). The study offered education that included fetal development, the first and second Leopold's maneuvers, and Leopold's maneuvers were administered in the 28th week of the women's pregnancy and re-administered in the 32nd and 36th weeks of pregnancy. No intervention was administered to the control group in these weeks, but the scales were administered.
RESULTS


The sociodemographic, obstetric, social support and baby-related characteristics of the groups were similar (p > .05). There were no statically significant differences between their mean PAI and FPAS scores in the 28th week of pregnancy (p > .05). The experimental group's mean PAI and the FPAS scores in the 32nd and 36th weeks of pregnancy were significantly higher than those of the control group (p < .01).
CONCLUSION


The study concluded that Leopold's maneuvers affected the pregnant women's prenatal attachment levels.",2020,"The sociodemographic, obstetric, social support and baby-related characteristics of the groups were similar (p > .05).","['100 pregnant women, 50 in the experimental group and 50 in the control group (https://www.random.org, accessed: 09.20.2016', ""pregnant women's prenatal attachment of a nursing practice using the first and second Leopold's maneuvers"", 'pregnancy class of a training and research hospital in Kocaeli, Turkey from September 2016 to September 2017']",[],"['mean PAI and the FPAS scores', 'mean PAI and FPAS scores', 'Prenatal Attachment Inventory (PAI) and the Fetal Position Awareness Scale (FPAS', ""pregnant women's prenatal attachment levels""]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0035168'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1286298', 'cui_str': 'Fetal position'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0222045'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.0320624,"The sociodemographic, obstetric, social support and baby-related characteristics of the groups were similar (p > .05).","[{'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Celik', 'Affiliation': 'Faculty of Medicine Research, Teaching Hospital, MSN, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Ergin', 'Affiliation': 'Faculty of Health Sciences, Midwifery Department, Kocaeli University, Kocaeli, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12297']
308,32242289,LINKS Training and Unit Support for Mental Health: a Group-randomized Effectiveness Trial.,"The LINKS curriculum, adapted from Britt et al. (2018a), was designed to improve unit climate, knowledge, and attitudes about mental health treatment seeking in military personnel. The present study extends this research by examining implementation options, comparing the effectiveness of LINKS to an active control condition with training delivered by non-experts and comparing modules that varied in training length. Eight Army platoons were randomly assigned to one of four conditions: (1) 1-h Active Control, (2) 2-h Active Control, (3) 1-h LINKS, or (4) 2-h LINKS. Two platoons were assigned to each condition. Surveys were administered at pre-training (T1), post-training (T2), and 3 months later (T3). Eighty-four participants completed all study phases. Regardless of training content, participants receiving the 2-h modules reported greater training acceptability than those receiving the 1-h modules. At T3, participants in the LINKS conditions reported more mental health knowledge than participants in the Active Control conditions. Sustained effects were also observed on a number of treatment barriers and facilitators, with the LINKS conditions generally leading to better outcomes. At T3, 2-h LINKS condition participants reported receiving more mental health treatment relative to the other conditions. Findings suggest that LINKS can be effectively delivered by non-expert trainers, is a viable intervention for targeting mental health treatment-seeking, and is optimally packaged in a 2-h module. The training might benefit from additional leadership training efforts.",2020,"Findings suggest that LINKS can be effectively delivered by non-expert trainers, is a viable intervention for targeting mental health treatment-seeking, and is optimally packaged in a 2-h module.","['Eight Army platoons', 'Eighty-four participants completed all study phases']","['Active Control, (2) 2-h Active Control, (3) 1-h LINKS, or (4) 2-h LINKS']","['mental health knowledge', 'training acceptability', 'unit climate, knowledge, and attitudes about mental health treatment seeking']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0700308', 'cui_str': 'Protium'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]",84.0,0.041514,"Findings suggest that LINKS can be effectively delivered by non-expert trainers, is a viable intervention for targeting mental health treatment-seeking, and is optimally packaged in a 2-h module.","[{'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Start', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Amiya', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'Dixon', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Britt', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Toblin', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Adler', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA. amy.b.adler.civ@mail.mil.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01106-6']
309,32246792,Effects of active commuting on health-related quality of life and sickness-related absence.,"Increased physical activity is associated with numerous health benefits. This study investigated the effect of active commuting (walking and cycling to work) on health-related quality of life (HRQoL) and absence days from work due to sickness in healthy working adults. In total, 73 participants (age: 46 ± 9 years), all working at a tertiary university hospital in Salzburg, Austria, were randomized into an intervention group (IG, n = 51) and a control group (CG, n = 22). The IG was asked to commute actively for twelve months, whereas the CG did not have to change their usual commuting behavior. IG was divided into two subgroups: IG-C (cycling, n = 26) was asked to commute by bicycle and IG-PT (public transport, n = 25) partially using public transportation and walked the remaining distance to work. Significant positive changes in IG were observed in four subcomponents of the SF-36 (physical functioning (95 [10] to 100 [8.8], P = .023), mental health (82 [15] to 86 [15], P = .036), vitality (65 [20] to 70 [14], P = .005), and general health (70 [19] to 80 [24], P = .004)) as well as the physical component summary score (56.5 [9] to 59.2 [6.3], P = .002). IG-C showed greater and more statistically significant changes regarding HRQoL compared to IG-PT. Associations between active commuting and sick-leave days were only observed in IG-PT (7.5 [14.8] to 4.0 [11.3] days, P = .038). In conclusion, active commuting improves various components of HRQoL and might therefore be a possible strategy to increase quality of life in the workforce.",2020,IG-C showed greater and more statistically significant changes regarding HRQoL compared to IG-PT.,"['healthy working adults', 'In total, 73 participants (age: 46 ± 9 years), all working at a tertiary university hospital in Salzburg, Austria']","['active commuting (walking and cycling to work', 'commute by bicycle and IG-PT (public transport, n=25) partially using public transportation and walked the remaining distance to work']","['mental health', 'vitality', 'general health', 'health-related quality of life (HRQoL', 'quality of life', 'HRQoL', 'physical component summary score', 'health-related quality of life and sickness related absence', 'SF-36 (physical functioning']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0009487', 'cui_str': 'Commuting'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]",73.0,0.0550253,IG-C showed greater and more statistically significant changes regarding HRQoL compared to IG-PT.,"[{'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Neumeier', 'Affiliation': 'Department of Cardiology, University Heart Centre, University Hospital Zurich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Loidl', 'Affiliation': 'Department of Geoinformatics-Z_GIS, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reich', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Fernandez La Puente de Battre', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Kissel', 'Affiliation': 'Department of Cardiology, University Heart Centre, University Hospital Zurich, Zürich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Templin', 'Affiliation': 'Department of Cardiology, University Heart Centre, University Hospital Zurich, Zürich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmied', 'Affiliation': 'Department of Cardiology, University Heart Centre, University Hospital Zurich, Zürich, Switzerland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Department of Cardiology, University Heart Centre, University Hospital Zurich, Zürich, Switzerland.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13667']
310,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
311,31431654,Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.,"OBJECTIVE


Extremely low birth weight children are at high risk for cognitive impairment.
STUDY DESIGN


Cognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.
RESULT


Higher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.
CONCLUSION


Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.",2019,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"['extremely low birth weight infants', 'extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed', 'extremely low birth weight children']",[],"['Cognitive outcome', 'Higher Family Resource Scale scores', 'cognitive scores']","[{'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0599714,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Fuller', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA. mfuller@sandiego.edu.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Vaucher', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Women, and Infants Hospital, Brown University, Providence, RI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0462-2']
312,31451248,"Effects of propolis and melatonin on oxidative stress, inflammation, and clinical status in patients with primary sepsis: Study protocol and review on previous studies.","BACKGROUND


Previous studies have explored the anti-inflammatory, anti-infection and oxidative stress reduction effects of propolis and melatonin in experimental studies. However, there are no studies at present exploring the effects of propolis and melatonin in patients with primary sepsis. The present study aims to evaluate the potential effects of propolis and melatonin as a pharmaceutical agent in patients with primary sepsis.
METHODS/DESIGN


The study will be conducted as a randomized controlled clinical trial at the Imamreza hospital. Patients with primary sepsis, in four equal groups, will be recruited for the study. The treatment drugs are propolis and melatonin and the placebo. The following primary and secondary outcome measures will be evaluated: APACHE II Score, SOFA score, NUTRIC score, inflammatory factors, and oxidative stress markers.
DISCUSSION


We describe the protocol for a clinical trial design evaluating the effects of simultaneous administration of propolis and melatonin in patients with primary sepsis. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of propolis and melatonin as an auxiliary treatment in patients with primary sepsis.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials: IRCT20181025041460N1. Registered on 6 November 2018.",2019,"The following primary and secondary outcome measures will be evaluated: APACHE II Score, SOFA score, NUTRIC score, inflammatory factors, and oxidative stress markers.
","['patients with primary sepsis', 'Patients with primary sepsis']","['placebo', 'melatonin', 'propolis and melatonin']","['evaluated: APACHE II Score, SOFA score, NUTRIC score, inflammatory factors, and oxidative stress markers', 'oxidative stress, inflammation, and clinical status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}]","[{'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}]",,0.220442,"The following primary and secondary outcome measures will be evaluated: APACHE II Score, SOFA score, NUTRIC score, inflammatory factors, and oxidative stress markers.
","[{'ForeName': 'Naseh', 'Initials': 'N', 'LastName': 'Pahlavani', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sedaghat', 'Affiliation': 'Cardiac Anesthesia Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Bagheri Moghaddam', 'Affiliation': 'Department of Internal Medicine and Critical Care, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyedeh Shabnam', 'Initials': 'SS', 'LastName': 'Mazloumi Kiapey', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Gholizadeh Navashenaq', 'Affiliation': 'Immunology Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Jarahi', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Reazvani', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Norouzy', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Nematy', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Safarian', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: SafarianM@mums.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghayour-Mobarhan', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Cardiovascular Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: ghayourm@mums.ac.ir.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.06.007']
313,31451249,"The effect of apple vinegar consumption on glycemic indices, blood pressure, oxidative stress, and homocysteine in patients with type 2 diabetes and dyslipidemia: A randomized controlled clinical trial.","BACKGROUND


Some foods and drinks contain special ingredients, causing impressive effects on human health. The aim of the current study was to assess the health effects of apple vinegar in patients with diabetes and dyslipidemia.
METHOD


Seventy participants with type 2 diabetes and hyperlipidemia were randomly assigned into an intervention and control group in order to assess the effect of 20 ml apple vinegar per day using an 8-week parallel study. Fasting blood sugar (FBS), homeostasis model assessment for insulin resistance (HOMA-IR), homeostasis model assessment for b-cell function (HOMA-B), quantitative insulin sensitivity checks index (QUICKI), insulin, malondialdehyde (MDA), 2,20-Diphenyl-1- picrylhydrazyl (DPPH), homocysteine, systolic blood pressure (SBP), and diastolic blood pressure (DBP) were measured at the beginning and end of the study.
RESULTS


The intervention with apple vinegar could significantly improve FBS (mean change: -10.16 ± 19.48 mg/dl, p = 0.006) and DPPH (mean change: 16.58 ± 11.56, p < 0.001) within intervention group and in comparison with control group (p < 0.001). Additionally, the significant increase of MDA in control group (p < 0.05) caused a considerable difference between two groups. Glycemic indices containing insulin, HOMA-IR, HOMA-B, and QUICKI decrease significantly in both groups (p < 0.05). No considerable effect was observed on blood pressure and homocysteine in intervention group as well as control group.
CONCLUSION


This trial provided some evidences that apple vinegar consumption may cause beneficial effects on glycemic indices and oxidative stress in individuals with diabetes and dyslipidemia. This randomized clinical trial was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir/) as 2013070710826N5.",2019,"Glycemic indices containing insulin, HOMA-IR, HOMA-B, and QUICKI decrease significantly in both groups (p < 0.05).","['individuals with diabetes and dyslipidemia', 'patients with diabetes and dyslipidemia', 'Seventy participants with type 2 diabetes and hyperlipidemia', 'patients with type 2 diabetes and dyslipidemia']","['20\xa0ml apple vinegar', 'apple vinegar consumption', 'apple vinegar']","['glycemic indices, blood pressure, oxidative stress, and homocysteine', 'MDA', 'blood pressure and homocysteine', 'FBS', 'Fasting blood sugar (FBS), homeostasis model assessment for insulin resistance (HOMA-IR), homeostasis model assessment for b-cell function (HOMA-B), quantitative insulin sensitivity checks index (QUICKI), insulin, malondialdehyde (MDA), 2,20-Diphenyl-1- picrylhydrazyl (DPPH), homocysteine, systolic blood pressure (SBP), and diastolic blood pressure (DBP', 'Glycemic indices containing insulin, HOMA-IR, HOMA-B, and QUICKI decrease', 'DPPH', 'glycemic indices and oxidative stress']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}]","[{'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0148405', 'cui_str': 'Vinegar'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0058372', 'cui_str': 'diphenyl'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",70.0,0.0501955,"Glycemic indices containing insulin, HOMA-IR, HOMA-B, and QUICKI decrease significantly in both groups (p < 0.05).","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gheflati', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Reihane', 'Initials': 'R', 'LastName': 'Bashiri', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ghadiri-Anari', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Javad Zavar', 'Initials': 'JZ', 'LastName': 'Reza', 'Affiliation': 'Department of Biochemistry, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Marjan Tajik', 'Initials': 'MT', 'LastName': 'Kord', 'Affiliation': 'Department of Biochemistry, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nadjarzadeh', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: azadnajarzadeh@ssu.ac.ir.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.06.006']
314,31806133,Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure.,"BACKGROUND


Moderate and moderately severe renal impairment are common in patients with heart failure and reduced ejection fraction, but whether beta-blockers are effective is unclear, leading to underuse of life-saving therapy.
OBJECTIVES


This study sought to investigate patient prognosis and the efficacy of beta-blockers according to renal function using estimated glomerular filtration rate (eGFR).
METHODS


Analysis of 16,740 individual patients with left ventricular ejection fraction <50% from 10 double-blind, placebo-controlled trials was performed. The authors report all-cause mortality on an intention-to-treat basis, adjusted for baseline covariates and stratified by heart rhythm.
RESULTS


Median eGFR at baseline was 63 (interquartile range: 50 to 77) ml/min/1.73 m 2 ; 4,584 patients (27.4%) had eGFR 45 to 59 ml/min/1.73 m 2 , and 2,286 (13.7%) 30 to 44 ml/min/1.73 m 2 . Over a median follow-up of 1.3 years, eGFR was independently associated with mortality, with a 12% higher risk of death for every 10 ml/min/1.73 m 2  lower eGFR (95% confidence interval [CI]: 10% to 15%; p < 0.001). In 13,861 patients in sinus rhythm, beta-blockers reduced mortality versus placebo; adjusted hazard ratio (HR): 0.73 for eGFR 45 to 59 ml/min/1.73 m 2  (95% CI: 0.62 to 0.86; p < 0.001) and 0.71 for eGFR 30 to 44 ml/min/1.73 m 2  (95% CI: 0.58 to 0.87; p = 0.001). The authors observed no deterioration in renal function over time in patients with moderate or moderately severe renal impairment, no difference in adverse events comparing beta-blockers with placebo, and higher mortality in patients with worsening renal function on follow-up. Due to exclusion criteria, there were insufficient patients with severe renal dysfunction (eGFR <30 ml/min/1.73 m 2 ) to draw conclusions. In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
CONCLUSIONS


Patients with heart failure, left ventricular ejection fraction <50% and sinus rhythm should receive beta-blocker therapy even with moderate or moderately severe renal dysfunction.",2019,"In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
","['16,740 individual patients with left ventricular ejection fraction\xa0<50% from 10 double-blind', 'm 2 ; 4,584 patients (27.4%) had eGFR 45 to 59\xa0ml', 'Patients with heart failure, left ventricular ejection fraction\xa0<50% and sinus rhythm', 'patients with heart failure and reduced ejection fraction', '2,879 patients with atrial fibrillation', 'Patients', 'patients with severe renal dysfunction (eGFR\xa0<30']","['beta-blockers', 'placebo']","['adverse events', 'severe renal dysfunction', 'renal function', 'risk of death', 'Beta-Blocker Efficacy', 'glomerular filtration rate (eGFR', 'mortality with beta-blockers']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",2879.0,0.289216,"In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
","[{'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Kotecha', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom; Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia. Electronic address: d.kotecha@bham.ac.uk.'}, {'ForeName': 'Simrat K', 'Initials': 'SK', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Flather', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Science, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Rosano', 'Affiliation': 'Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Kardiologie, Angiologie und Internistische Intensivmedizin, Universitatsklinikum des Saarlandes, Homburg/Saar, Germany.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wikstrand', 'Affiliation': 'Wallenberg Laboratory for Cardiovascular Research, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology, Charite Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Centre Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manzano', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Ramón y Cajal, Universidad de Alcalá (IRYCIS), Plaza de San Diego, Madrid, Spain.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'von Lueder', 'Affiliation': 'Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia; Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rigby', 'Affiliation': 'Hull York Medical School, Faculty of Health Sciences, University of Hull, Kingston-upon-Hull, United Kingdom.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Andersson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital and Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kjekshus', 'Affiliation': 'Rikshospitalet University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wedel', 'Affiliation': 'Health Metrics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Klinik fur Kardiologie, UniversitätsSpital Zürich, Zürich, Switzerland.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Damman', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Centre Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Redon', 'Affiliation': 'INCLIVA Biomedical Research Institute, Valencia, Spain.'}, {'ForeName': 'Andrew J S', 'Initials': 'AJS', 'LastName': 'Coats', 'Affiliation': 'Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.059']
315,32241993,[The effectiveness of local therapy of acute inflammatory diseases of the upper respiratory tract].,"Acute bacterial rhinosinusitis (ABRS) is one of the most common diseases in outpatient practice with a steady tendency to increase of complicated forms in recent years. The risk of antibiotic resistance makes it necessary to search for effective pathogenetic methods of ABRS treatment.
OBJECTIVE


To evaluate the efficacy of inhalation therapy with compressor nebulizer using Fluimucil Antibiotic IT in the treatment of ABRS and acute laryngotracheitis in outpatient practice.
MATERIAL AND METHODS


Patients with ABRS were divided into two sex- and age-matched groups of 26 people each. The first group was treated with 250 mg of Fluimucil Antibiotic IT inhalations by the use of Norditalia HI-NEB compressor nebulizer once a day. The second group was treated with amoxicillin/clavulanate 875 mg + 125 mg orally two times a day.
RESULTS


In the first group, the cough disappeared significantly earlier (on day 5-6) than in the second group (on day 7-8). In the first group, nasal congestion also disappeared significantly earlier (on day 3-5) than in the second group (on day 4-6). There was no significant difference in the reduction of intoxication syndrome and nasal secretions in both groups.
CONCLUSION


Local antibacterial and mucolytic therapy in the initial stages of ABRS and acute laryngotracheitis reduces rhinological symptoms and coughing, similar to systemic antibacterial therapy. The use of Fluimucil Antibiotic IT in the early stages of the treatment provides an opportunity to avoid systemic antibiotics, which reduces the risk of antibiotic resistance as well as side effects in patients.",2020,"In the first group, nasal congestion also disappeared significantly earlier (on day 3-5) than in the second group (on day 4-6).","['acute inflammatory diseases of the upper respiratory tract', 'Acute bacterial rhinosinusitis (ABRS', 'Patients with ABRS were divided into two sex- and age-matched groups of 26 people each']","['Local antibacterial and mucolytic therapy', 'Fluimucil Antibiotic IT inhalations', 'amoxicillin/clavulanate 875 mg + 125 mg orally two times a day', 'local therapy']","['nasal congestion', 'intoxication syndrome and nasal secretions']","[{'cui': 'C1290885', 'cui_str': 'Acute inflammatory disease'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948780', 'cui_str': 'Rhinosinusitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026698', 'cui_str': 'Mucolytic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0699251', 'cui_str': 'NAC Zambon'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",,0.013081,"In the first group, nasal congestion also disappeared significantly earlier (on day 3-5) than in the second group (on day 4-6).","[{'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Kozlov', 'Affiliation': 'Central State Medical Academy of Administrative Directorate of the President of the Russian Federation, Department of Otolaryngology, Moscow, Russia, 121359.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Savlevich', 'Affiliation': 'Central State Medical Academy of Administrative Directorate of the President of the Russian Federation, Department of Otolaryngology, Moscow, Russia, 121359.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Gorbunov', 'Affiliation': 'Central State Medical Academy of Administrative Directorate of the President of the Russian Federation, Department of Otolaryngology, Moscow, Russia, 121359.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Felshin', 'Affiliation': 'Polyclinic No. 4 of Administrative Directorate of the President of the Russian Federation, Moscow, Russia, 121151.'}]",Vestnik otorinolaringologii,['10.17116/otorino20208501168']
316,32236417,Predictors of Smoking Cessation Attempts and Success Following Motivation-Phase Interventions Among People Initially Unwilling to Quit Smoking.,"INTRODUCTION


Most people who smoke cigarettes are not willing (ie, not ready) to make a quit attempt (QA) at any given time. Unfortunately, interventions intended to increase QAs and the success of QAs are only modestly effective. Identifying processes leading to QAs and quitting success could guide intervention development.
AIMS AND METHODS


This is a secondary analysis of a randomized factorial trial of 6 weeks of motivation-phase interventions among primary care patients (N = 517) who were initially unwilling to quit but were willing to reduce their smoking. Using logistic regression, we controlled for treatment condition and tested whether baseline or change in smoking-related constructs after 6 weeks of treatment predicted (1) making an at least 24 h QA between weeks 6 and 26 and (2) quitting success at week 26 (7-day point-prevalence abstinence among those who made a QA). Predictors included cigarettes/day, time to first cigarette, motivation to quit, quitting self-efficacy, anticipated urges to smoke if quit, positive affect, negative affect, and time spent around others who smoke.
RESULTS


In multivariable models that included all smoking-related constructs, changes in the following variables predicted initiating a QA above and beyond other variables: greater baseline time to first cigarette (odds ratio [OR] = 1.60), increases in time to first cigarette (OR = 1.27), and increases in quitting self-efficacy (OR = 1.14). Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR = 1.36).
CONCLUSION


Predictors of making a QA differed from predictors of quitting success. Predictors of QAs and success could each serve as important treatment targets of motivation-phase interventions.
IMPLICATIONS


Motivation-phase interventions for people initially unwilling to quit smoking cigarettes may be improved by striving to increase their (1) time to first cigarette and quitting self-efficacy to promote QAs and (2) motivation to quit to promote quit success. Future experimental tests of such interventions are needed to identify causal determinants of QAs and quitting success.",2020,"Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR=1.36).
","['primary care patients (N=517) who were initially unwilling to quit but were willing to reduce their smoking', 'people initially unwilling to quit smoking']",['motivation-phase interventions'],"['time to first cigarette', 'quitting self-efficacy', 'cigarettes/day, time-to-first cigarette, motivation to quit, quitting self-efficacy, anticipated urges to smoke if quit, positive affect, negative affect, and time spent around others who smoke', 'quitting success']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0615191,"Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR=1.36).
","[{'ForeName': 'Elias M', 'Initials': 'EM', 'LastName': 'Klemperer', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Mermelstein', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'Department of Human Development and Family Studies and Statistics, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa051']
317,32246748,"Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: A randomized, placebo-controlled trial on temporomandibular side-effects.","PURPOSE


To assess the differences in the frequency of clinical signs of temporomandibular disorder (TMD) pain and mandibular function impairment between mandibular advancement device (MAD) and nasal continuous positive airway pressure (nCPAP) therapies in obstructive sleep apnea (OSA) patients at baseline and after 6 month of treatment.
METHODS


This study concerns a secondary analysis of a randomized placebo-controlled trial in which different treatment effects of an objectively titrated MAD were compared with those of nCPAP and an intra-oral placebo appliance in a parallel design. Sixty-four mild to severe OSA patients (52.0 ± 9.6 years) were randomly assigned to these three groups. All patients underwent a shortened functional examination of their masticatory system at baseline and after 6 months to establish the presence of clinical signs of TMD pain. Mandibular function impairment was assessed with a questionnaire.
RESULTS


Clinical signs of TMD pain were only rarely present at baseline and therapy evaluation. No significant differences were found between the three groups in the (low) frequency of clinical signs of TMD pain at both time points (p = .401-.176). In addition, the (low) scores of mandibular function impairment did not differ between the three groups either, neither at baseline (p = .744) nor after 6 months (p = .359).
CONCLUSIONS


A low frequency of clinical signs of TMD pain in mild to severe OSA patients was found after 6 months, regardless of treatment with MAD or nCPAP. In addition, no difference in mandibular function impairment was observed between the different treatment modalities.",2020,No significant differences were found between the three groups in the (low) frequency of clinical signs of TMD pain at both time points (p = .401-.176).,"['obstructive sleep apnea', 'mild to severe OSA patients', 'Sixty-four mild to severe OSA patients (52.0\u2009±\u20099.6\u2009years', 'obstructive sleep apnea (OSA) patients at baseline and after 6 month of treatment']","['placebo', 'nCPAP and an intra-oral placebo appliance', 'mandibular advancement device (MAD) and nasal continuous positive airway pressure (nCPAP) therapies', 'Oral appliance therapy versus nasal continuous positive airway pressure']","['TMD pain', 'mandibular function impairment', 'temporomandibular disorder (TMD) pain and mandibular function impairment', 'Mandibular function impairment', 'low) frequency of clinical signs of TMD pain']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",64.0,0.118151,No significant differences were found between the three groups in the (low) frequency of clinical signs of TMD pain at both time points (p = .401-.176).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nikolopoulou', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre of Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ghizlane', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre of Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Ahlberg', 'Affiliation': 'Department of Oral and Maxillofacial Diseases, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hans L', 'Initials': 'HL', 'LastName': 'Hamburger', 'Affiliation': 'Amsterdam Sleep Centre, Boerhaave Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'de Lange', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Amsterdam University Medical Centre and Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre of Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Clinical and experimental dental research,['10.1002/cre2.288']
318,32199156,"The effects of alcohol dose, exposure to an in-vehicle alcohol feedback device, and subjective responses to alcohol on the decision to drink-drive in young drivers.","BACKGROUND


Several factors may influence the decision to drink-drive (DD) in young drivers, such as the amount of alcohol consumed, exposure to an in-vehicle alcohol feedback device, and subjective responses to alcohol. Understanding of their influence on DD is lacking and may be key for targeted intervention. This randomized controlled, double-blinded, driving simulation experiment tested three main hypotheses; young drivers are more likely to engage in DD with: i) lower alcohol dose; ii) lack of exposure to an in-vehicle alcohol feedback (FB) device; and iii) lower subjective responses to alcohol intoxication (SR). Interactions between the decision to DD and SR, FB and sex were also explored.
METHODS


Males (n = 80) and females (n = 80) aged 20-24 years old were randomly assigned to two conditions: i) alcohol dose (0.45 g/kg or 0.65 g/kg); and ii) exposure to an in-vehicle alcohol feedback device (no or yes). Assessment of participants' SR following alcohol intake was based upon two measures: i) subjective intoxication measured by the discrepancy between an objective measure of intoxication and their subjective estimate of intoxication; and ii) perception of capacity to drive safely under alcohol (for both variables, a higher score represents lower SR). Participants were then asked to make either a negative or positive decision to DD while confronted with time-based contingencies related to their decision. Logistic regression and moderation analyses tested hypotheses.
RESULTS


Approximately 60 % of participants decided to DD. Higher odds of DD were found in participants reporting higher capacity to drive (adjusted odds ratio [β] = 1.03, 95 % confidence interval [CI] = 1.01-1.05) and who were males (β  = 7.70; 95 % CI = 1.34-5.57). A main effect of either FB exposure or alcohol dose was not detected. Moderation analysis showed that lower SR, represented by higher perceived capacity to drive safely under alcohol was selectively predictive of greater likelihood of a decision to DD in participants not exposed to FB (effect = .054, p < .001, 95 % CI = .026-.083).
CONCLUSIONS


Lower SR was found to be associated with a greater likelihood of the decision to DD in young drivers, while exposure to an in-vehicle FB device had no effect on DD. Importantly, FB exposure appeared to disrupt the relationship between lower SR and the decision to DD, signaling that FB may be selectively effective for young drivers possessing lower SR. Future studies are needed to clarify whether FB technology, and other interventions, can be targeted to deter DD in the young drivers most likely to benefit.",2020,"Higher odds of DD were found in participants reporting higher capacity to drive (adjusted odds ratio [β] = 1.03, 95 % confidence interval [CI] = 1.01-1.05) and who were males (β  = 7.70; 95 % CI = 1.34-5.57).","['young drivers', 'Males (n\u202f=\u202f80) and females (n\u202f=\u202f80) aged 20-24 years old']","['alcohol dose (0.45\u202fg/kg or 0.65\u202fg/kg); and ii) exposure to an in-vehicle alcohol feedback device (no or yes', 'FB exposure or alcohol', 'alcohol intoxication (SR']",['intoxication and their subjective estimate of intoxication; and ii) perception of capacity to drive safely under alcohol'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C4517471', 'cui_str': '0.65'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0001969', 'cui_str': 'Drunkenness'}]","[{'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",,0.0568622,"Higher odds of DD were found in participants reporting higher capacity to drive (adjusted odds ratio [β] = 1.03, 95 % confidence interval [CI] = 1.01-1.05) and who were males (β  = 7.70; 95 % CI = 1.34-5.57).","[{'ForeName': 'Marie Claude', 'Initials': 'MC', 'LastName': 'Ouimet', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Sherbrooke, 150, Charles-Le Moyne PL, Suite 200, Longueuil, Quebec, J4K 0A8, Canada. Electronic address: marie.claude.ouimet@usherbrooke.ca.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Quebec, H3A 1A1, Canada; Douglas Hospital Research Centre, Perry Pavilion, Room E-4109, 6875, Boulevard LaSalle, Montreal, Quebec, H4H 1R3, Canada. Electronic address: thomas.brown@mcgill.ca.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Corado', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Sherbrooke, 150, Charles-Le Moyne PL, Suite 200, Longueuil, Quebec, J4K 0A8, Canada. Electronic address: lidia.corado@usherbrooke.ca.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Paquette', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Sherbrooke, 150, Charles-Le Moyne PL, Suite 200, Longueuil, Quebec, J4K 0A8, Canada. Electronic address: martin.paquette4@usherbrooke.ca.'}, {'ForeName': 'Robyn D', 'Initials': 'RD', 'LastName': 'Robertson', 'Affiliation': 'Traffic Injury Research Foundation, 171 Nepean Street, Suite 200, Ottawa, Ontario, K2P 0B4, Canada. Electronic address: robynr@tirf.ca.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105495']
319,32203810,"Metabolic linkages between indoor negative air ions, particulate matter and cardiorespiratory function: A randomized, double-blind crossover study among children.","BACKGROUND


Ionization air purifiers, which purify particulate matter (PM) by producing vast number of negative air ions (NAI), are widely used. Recent study implied that ionization air purification could bring respiratory benefits but deterioration of heart rate variability (HRV). However, its underlying molecular mechanisms remain unclear.
OBJECTIVES


To explore the molecular linkages between indoor NAI, decreased PM and the cardiorespiratory effect after purification.
METHODS


Urine samples were collected from 44 healthy children three times of each study period (real and sham purification) in an existing randomized, double-blind crossover study. Ultra-high performance liquid chromatography/mass spectrometry was conducted in metabolomics analysis, the associations between indoor NAI, decreased PM and the cardiorespiratory function were investigated via the meet-in-metabolite approach (MIMA) based on statistical and metabolic pathway analysis. Mixed-effect models were used to establish associations between exposure, health parameters and metabolites.
RESULTS


Twenty-eight and fourteen metabolites were identified with significant correlations to NAI and PM, respectively. Besides, eight and eighteen metabolites were separately associated with respiratory function and HRV. The increased NAI and decreased PM improved respiratory function mainly with eight pathways, promoting energy production, anti-inflammation and anti-oxidation capacity. Decreased PM ameliorated HRV with six main pathways, increasing energy production and anti-inflammation capacity while increased NAI deteriorated HRV with five main pathways, lowering energy generation and anti-oxidation capacity.
CONCLUSIONS


Increased NAI and decreased PM ameliorated respiratory function by increasing energy production, improving anti-inflammation and anti-oxidation capacity. Decreased PM improved cardiac autonomic function by increasing energy production and anti-inflammation capacity, while these benefits were overcast by massive NAI via lowering energy generation and anti-oxidation capacity with different metabolic pathways.",2020,"Decreased PM ameliorated HRV with six main pathways, increasing energy production and anti-inflammation capacity while increased NAI deteriorated HRV with five main pathways, lowering energy generation and anti-oxidation capacity.
","['Urine samples were collected from 44 healthy children three times of each study period (real and sham purification', 'children']",[],"['energy production and anti-inflammation capacity', 'anti-inflammation and anti-oxidation capacity', 'Decreased PM improved cardiac autonomic function', 'energy production, anti-inflammation and anti-oxidation capacity']","[{'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0243114', 'cui_str': 'purification'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0033268'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",44.0,0.0576249,"Decreased PM ameliorated HRV with six main pathways, increasing energy production and anti-inflammation capacity while increased NAI deteriorated HRV with five main pathways, lowering energy generation and anti-oxidation capacity.
","[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Mengtian', 'Initials': 'M', 'LastName': 'Chu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Heqing', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Furong', 'Initials': 'F', 'LastName': 'Deng', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}]",Environment international,['10.1016/j.envint.2020.105663']
320,32240629,Once-weekly rifapentine and isoniazid for tuberculosis prevention in patients with HIV taking dolutegravir-based antiretroviral therapy: a phase 1/2 trial.,"BACKGROUND


Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV. However, a small previous trial of such therapy with dolutegravir in healthy, HIV-negative adults was halted early after two of the four patients developed serious adverse events. Because of the potential use of this therapy, and variable safety outcomes of tuberculosis drugs seen in patients with and without HIV, we aimed to characterise safety, pharmacokinetics, and virological suppression in adults who are HIV positive.
METHODS


DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa). Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of efavirenz-based or dolutegravir-based regimens were recruited in three consecutive groups, subject to approval by the independent safety monitoring committee. Participants received 50 mg of daily dolutegravir in place of efavirenz for 8 weeks, then began once-weekly rifapentine (900 mg)-isoniazid (900 mg) for 12 weeks. Groups 1A (n=12) and 1B (n=18) had intensive dolutegravir pharmacokinetic sampling at week 8 (before rifapentine-isoniazid), at week 11 (after the third dose of rifapentine)-isoniazid and at week 16 after the eighth dose. Group 2 (n=30) were treated with the same schedule and had sparse dolutegravir pharmacokinetic sampling at weeks 8, 11, and 16. Participants were followed 4 weeks after completion of prophylactic tuberculosis treatment. HIV viral loads were measured at baseline and at weeks 11 and 24. Primary endpoints were adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics, assessed in participants who began rifapentine-isoniazid. This trial was registered at ClinicalTrials.gov, NCT03435146.
FINDINGS


Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A). 43 (70%) of 60 participants were women and all participants were black African. Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2  (24·0-32·9). Three grade 3 adverse events occurred; two elevated creatinine and one hypertension. Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve. Overall geometric mean ratio of trough concentrations with versus without rifapentine-isoniazid was 0·53 (90% CI 0·49-0·56) though this ratio varied by day after rifapentine-isoniazid dose. All but one trough value was above the 90% maximal inhibitory concentration for dolutegravir and HIV viral loads were less than 40 copies per mL in all patients.
INTERPRETATION


Our results suggest 12 doses of once-weekly rifapentine-isoniazid can be given for tuberculosis prophylaxis to patients with HIV taking dolutegravir-based antiretroviral therapy, without dose adjustments. Further exploration of the pharmacokinetics, safety, and efficacy in children and pharmacodynamics in individuals naive to antiretroviral therapy is needed.
FUNDING


UNITAID.",2020,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"['43 (70%) of 60 participants were women and all participants were black African', 'patients with HIV taking dolutegravir-based antiretroviral therapy', 'Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of', 'Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2  (24·0-32·9', 'DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa', 'adults who are HIV positive', 'Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A', 'children and pharmacodynamics in individuals naive to antiretroviral therapy', 'patients with and without HIV', 'areas with high co-endemicity with HIV']","['Rifapentine-isoniazid', 'daily dolutegravir in place of efavirenz', 'rifapentine-isoniazid', 'rifapentine and isoniazid', 'rifapentine', 'isoniazid', 'efavirenz-based or dolutegravir-based regimens', 'rifapentine)-isoniazid']","['dolutegravir and HIV viral loads', 'dolutegravir clearance', 'Overall geometric mean ratio of trough concentrations', 'dolutegravir area', 'intensive dolutegravir pharmacokinetic sampling', 'HIV viral loads', 'adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics', 'serious adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0441862', 'cui_str': 'Group 1A'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",61.0,0.385174,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kdooley1@jhmi.edu.'}, {'ForeName': 'Radojkam', 'Initials': 'R', 'LastName': 'Savic', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Gupte', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Vinodh A', 'Initials': 'VA', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wolf', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Modulakgotla', 'Initials': 'M', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Morongwe', 'Initials': 'M', 'LastName': 'Likoti', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Fyvie', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Shibambo', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Beattie', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Churchyard', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30032-1']
321,31370748,Comparison between two premedication regimens of dexamethasone before a pemetrexed-based chemotherapy: A single-center experience study.,"Pemetrexed, frequently used for the treatment of pulmonary adenocarcinoma, may cause cutaneous reactions that can be reduced with three oral doses of dexamethasone starting the day before treatment, and continuing after chemotherapy for a number of doses which varies according to the emetogenic potential of the protocol. Dexamethasone may induce side effects and no guideline suggests the conduct to favor when dexamethasone doses are omitted before treatment with pemetrexed. This study was performed to evaluate the efficacy of a simplified regimen of dexamethasone administered before a pemetrexed-based chemotherapy in preventing cutaneous toxicities. A prospective study was conducted with patients starting a pemetrexed-based treatment between February 2016 and August 2017 at the ambulatory oncology clinic of an academic hospital. Patients were divided into two groups, one receiving the usual oral premedication and the other receiving a 20-mg intravenous dose of dexamethasone prior to chemotherapy. Among the 70 patients included, 39 received the alternative regimen prior to a total of 114 chemotherapy cycles, while the other 31 patients received the usual premedication before a total of 154 cycles. The cutaneous toxicity incidence was of 10 events in the simplified treatment group compared to 9 events in the standard group ( p  = 0.35). These events occurred in nine patients within the experimental group and five patients within the control group ( p  = 0.56). A single intravenous dexamethasone regimen represents a valid alternative to the usual prophylaxis in preventing cutaneous reactions.",2020,These events occurred in nine patients within the experimental group and five patients within the control group ( p  = 0.56).,"['70 patients included, 39 received the alternative regimen prior to a total of 114 chemotherapy cycles, while the other 31 patients received the', 'patients starting a pemetrexed-based treatment between February 2016 and August 2017 at the ambulatory oncology clinic of an academic hospital']","['Dexamethasone', 'usual premedication', 'pemetrexed-based chemotherapy', 'dexamethasone', 'Pemetrexed', 'dexamethasone prior to chemotherapy']","['cutaneous toxicity incidence', 'cutaneous toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0162365,These events occurred in nine patients within the experimental group and five patients within the control group ( p  = 0.56).,"[{'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Groleau', 'Affiliation': 'Département de pharmacie, Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec, Hôpital Sainte-Croix, Québec, Canada.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': 'Département de pharmacie, Institut Universitaire de Cardiologie et de Pneumologie de Québec (Hôpital Laval), Québec, Canada.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219862040']
322,31451252,The utility of nutritional supportive care with an eicosapentaenoic acid (EPA)-enriched nutrition agent during pre-operative chemoradiotherapy for pancreatic cancer: Prospective randomized control study.,"BACKGROUND & AIMS


Neoadjuvant chemoradiotherapy (NACRT) for pancreatic cancer (PC) is potentially associated with various toxicities, which can lead to impaired nutritional status. Eicosapentaenoic acid (EPA) can reduce proinflammatory cytokines and positively influence cancer cachexia syndrome. The aim of this study is to clarify the utility of EPA enriched nutrition support during NACRT for PC.
METHODS


We randomly assigned 62 patients with PC that received NACRT to either a nutrition intervention (NI) or a normal diet (ND). Patients in the NI group received 2 bottles/day (550 kcal/day) of an EPA-enriched nutrition supplement during NACRT. The primary endpoints were the before-to-after NACRT ratios (post/pre ratios) of skeletal muscle mass and psoas major muscle area (PMA). The secondary endpoints were the post/pre ratios of other nutritional parameters and treatment-related toxicities.
RESULTS


Only 14 patients (45.2%) in the NI group consumed more than 50% of the EPA-enriched supplement provided. The post/pre ratio of skeletal muscle mass in the NI group (0.99 ± 0.060) was not significantly different from that of the ND group (0.96 ± 0.079, p = 0.102). However, patients that consumed ≥50% of the EPA-enriched supplement (the good intake group) had significantly higher skeletal muscle mass ratios than patients in the ND group (p = 0.042). The PMA ratio was significantly higher in the NI group (0.96 ± 0.081) than in the ND group (0.89 ± 0.072, p = 0.001). The NI and ND groups were not significantly different in other nutritional parameters or in NACRT-related toxicity.
CONCLUSIONS


We found that EPA-enriched intake could potentially improve the nutritional status of patients with PC that received NACRT, but it was difficult for many patients to drink, due to its disagreeable taste. University Hospital Medical Information Network (http://www.umin.ac.jp), registration number UMIN000033589, https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000038300.",2019,"The PMA ratio was significantly higher in the NI group (0.96 ± 0.081) than in the ND group (0.89 ± 0.072, p = 0.001).","['62 patients with PC that received', 'pancreatic cancer', 'pancreatic cancer (PC']","['NACRT to either a nutrition intervention (NI) or a normal diet (ND', 'Eicosapentaenoic acid (EPA', 'eicosapentaenoic acid (EPA)-enriched nutrition agent during pre-operative chemoradiotherapy', 'EPA-enriched nutrition supplement during NACRT', 'NACRT', 'Neoadjuvant chemoradiotherapy (NACRT']","['pre ratio of skeletal muscle mass', 'skeletal muscle mass ratios', 'NACRT ratios (post/pre ratios) of skeletal muscle mass and psoas major muscle area (PMA', 'PMA ratio', 'post/pre ratios of other nutritional parameters and treatment-related toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0224419', 'cui_str': 'Structure of psoas major muscle'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0048451', 'cui_str': 'p-methoxy-alpha-methylphenethylamine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",62.0,0.0677359,"The PMA ratio was significantly higher in the NI group (0.96 ± 0.081) than in the ND group (0.89 ± 0.072, p = 0.001).","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Akita', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan; Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Japan. Electronic address: hirofumiakita@hotmail.com.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Asukai', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tomokuni', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Wada', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Marukawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Endocrinology and Metabolism, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Yoshitomo', 'Initials': 'Y', 'LastName': 'Yanagimoto', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nishimura', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Yasui', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Ayami', 'Initials': 'A', 'LastName': 'Ochi', 'Affiliation': 'Department of Nursing, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Ayano', 'Initials': 'A', 'LastName': 'Kagawa', 'Affiliation': 'Department of Nursing, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Soh', 'Affiliation': 'Department of Nutrition, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Nutrition, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Sakon', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Japan.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.06.003']
323,31451273,A polyol-stevia blended sugar replacer exhibits low glycemic response among human subjects.,"BACKGROUND & AIMS


Consumption of sugars in food and beverages has increased at an alarming rate. While excessive daily sugar intake has been well-associated as the onset of medical complications, additional sugars are still used in manufactured food products just to satisfy the consumers' needs. Hence, there is a need to develop sugar replacers that have low glycemic response without compromising the organoleptic characteristics of food products. This study aimed to determine if SUITENA™, a novel sweetener containing erythritol, xylitol, and Stevia, has low glycemic response upon consumption by human subjects.
METHODS


Six human subjects were randomly chosen and were healthy at the point of experimentation. Capillary blood was collected via finger-prick method to monitor the glycemic response of every individual for 90 min after ingestion of sugar solution.
RESULTS


It was found that the mean area under the curve (AUC) of the dextrose standard was 11.8-fold higher (p < 0.05) than the AUC of SUITENA™. SUITENA™ was not able to increase blood glucose level for up to 90 min while a spike in blood glucose level was observed from 15 min post-consumption of dextrose solution. We found that SUITENA™ has elicited a glycemic response 8% relative to the standard. Such low glycemic response has been reported by studies on other novel sugars.
CONCLUSION


This preliminary finding suggested that SUITENA™ is a healthier alternative to fast sugars due to its low glycemic response. A larger sampling size is required to confirm the results.",2019,SUITENA™ was not able to increase blood glucose level for up to 90 min while a spike in blood glucose level was observed from 15 min post-consumption of dextrose solution.,"['human subjects', 'Six human subjects were randomly chosen and were healthy at the point of experimentation']",[],"['mean area under the curve (AUC', 'blood glucose level']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",,0.0224678,SUITENA™ was not able to increase blood glucose level for up to 90 min while a spike in blood glucose level was observed from 15 min post-consumption of dextrose solution.,"[{'ForeName': 'Allan W R', 'Initials': 'AWR', 'LastName': 'Ng', 'Affiliation': 'School of Science, Monash University Malaysia, Jalan Lagoon Selatan Subang Jaya, 47500, Selangor Darul Ehsan, Malaysia.'}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Loh', 'Affiliation': 'Fiatec Biosystem Sdn Bhd, 5 Jalan TPP 1/7, Taman Perindustrian Puchong, 47160 Puchong, Selangor, Malaysia.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'School of Science, Monash University Malaysia, Jalan Lagoon Selatan Subang Jaya, 47500, Selangor Darul Ehsan, Malaysia; Department of Biochemistry, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant, Dehradun, 248016, Uttarakhand, India.'}, {'ForeName': 'Kumaran', 'Initials': 'K', 'LastName': 'Narayanan', 'Affiliation': 'School of Science, Monash University Malaysia, Jalan Lagoon Selatan Subang Jaya, 47500, Selangor Darul Ehsan, Malaysia. Electronic address: kumaran.narayanan@monash.edu.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.07.014']
324,32072866,Effects of a Video-based Intervention on Caregiver Confidence for Managing Dementia Care Challenges: Findings from the FamTechCare Clinical Trial.,"OBJECTIVES


The Supporting Family Caregivers with Technology trial tested the FamTechCare video support intervention against telephone support. Dementia caregivers' video-recorded challenging care encounters and an interdisciplinary team provided tailored feedback. This paper reports on the effects of the intervention on caregiver confidence in managing priority challenges, a secondary outcome of this non-blinded parallel randomized controlled trial.
METHODS


Caregiver/person living with dementia dyads were randomized to the experimental FamTechCare video support (n = 43) or attention control telephone support (n = 41) groups. Caregivers providing in-home care to a person living with mild or more severe dementia were eligible. Caregivers identified three priority challenges using the Caregiver Target Problems Questionnaire and rated the frequency and severity of each challenge and their confidence managing the challenge at baseline and 3-months. Challenges were classified using the FamTechCare Technology-supported Dementia Care Typology. Effects on confidence were compared between groups using the Wilcoxon rank-sum test and within groups using the Wilcoxon signed-rank test.
RESULTS


Caregiver priority challenges included managing dementia behaviors, understanding disease expectations, and performing activity of daily living care. Improvements were observed across the three categories in both groups; however, not all changes were statistically significant. No significant differences were identified between groups.
CONCLUSION


Caregivers in the FamTechCare group reported benefit across all priority challenges including managing dementia behaviors, understanding disease expectations, and performing activity of daily living care.
CLINICAL IMPLICATIONS


Innovative technology provides new opportunities to support family caregivers in dementia home care. Video-recording can be used to enhance support for family caregivers facing care challenges.",2020,"Improvements were observed across the three categories in both groups; however, not all changes were statistically significant.","['Caregiver/person living with dementia dyads', 'person living with mild or more severe dementia were eligible']","['FamTechCare video support intervention against telephone support', 'Video-based Intervention', 'FamTechCare', 'experimental FamTechCare video support (n\xa0=\xa043) or attention control telephone support']","['Caregiver Confidence', 'caregiver confidence']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia (disorder)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",,0.0576217,"Improvements were observed across the three categories in both groups; however, not all changes were statistically significant.","[{'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'College of Nursing, University of Iowa , Iowa City, Iowa, USA.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, University of Kansas , Kansas City, Kansas, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Perkhounkova', 'Affiliation': 'College of Nursing, University of Iowa , Iowa City, Iowa, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'College of Nursing, University of Iowa , Iowa City, Iowa, USA.'}, {'ForeName': 'Carissa K', 'Initials': 'CK', 'LastName': 'Coleman', 'Affiliation': 'School of Nursing, University of Kansas , Kansas City, Kansas, USA.'}]",Clinical gerontologist,['10.1080/07317115.2020.1729917']
325,32241351,"The effects of a clinically feasible application of low-level laser therapy on the rate of orthodontic tooth movement: A triple-blind, split-mouth, randomized controlled trial.","INTRODUCTION


This split-mouth trial aimed to investigate the effect of low-level laser therapy (LLLT) on the amount of maxillary canine distalization when applied every 4 weeks over 12 weeks.
METHODS


Twenty-two adolescents and young adults (15 female, 7 male; aged 13-25 years; n = 22) requiring bilateral maxillary first premolar extractions were recruited. After extractions and leveling-alignment, canines were retracted using closed-coil nickel-titanium springs delivering 150 g of force. LLLT was applied to 8 intraoral points on the buccal and palatal sides around the canine root for 10 seconds per point, on day 0, 28, and 56 with the control side receiving sham application. Alginate impressions were taken every 4 weeks on day 0, 28, 56, and 84. The amount of tooth movement, anchorage loss, and canine rotation were measured digitally. Randomization was generated using www.randomisation.com and allocation concealment through sequentially numbered, opaque, sealed envelopes. Participants, operator, and statistic assessor were blinded. Linear regression modeling accounting for clustering within each patient was used to identify differences between LLLT and control sides.
RESULTS


Twenty-one patients completed the study. The total amount of tooth movement was similar in the LLLT (2.55 ± 0.73 mm) and control group (2.30 ± 0.86 mm), whereas 0.25 mm (95% confidence interval, -0.21, 0.71 mm) of difference was insignificant (P = 0.27). No significant differences were found for anchorage loss (P = 0.22) or canine rotation (P = 0.25). No harms were reported.
CONCLUSIONS


Application of LLLT every 4 weeks did not result in differences in the amount of tooth movement, anchorage loss, and canine rotation during extraction space closure.",2020,No significant differences were found for anchorage loss (P = 0.22) or canine rotation (P = 0.25).,"['Twenty-two adolescents and young adults (15 female, 7 male; aged 13-25\xa0years; n\xa0=\xa022) requiring bilateral maxillary first premolar extractions were recruited', 'Twenty-one patients completed the study']","['LLLT', 'low-level laser therapy', 'low-level laser therapy (LLLT']","['total amount of tooth movement', 'canine rotation', 'anchorage loss', 'amount of tooth movement, anchorage loss, and canine rotation', 'rate of orthodontic tooth movement']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",22.0,0.446363,No significant differences were found for anchorage loss (P = 0.22) or canine rotation (P = 0.25).,"[{'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Oyku', 'Initials': 'O', 'LastName': 'Dalci', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Spyridon N', 'Initials': 'SN', 'LastName': 'Papageorgiou', 'Affiliation': 'Center of Dental Medicine, Clinic of Orthodontics and Paediatric Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M Ali', 'Initials': 'MA', 'LastName': 'Darendeliler', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Papadopoulou', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia. Electronic address: alexandra.papadopoulou@sydney.edu.au.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.12.005']
326,32222056,Improving pediatric endocrinology trainees' knowledge about insulin pumps and continuous glucose monitors with online spaced education: Technology Knowledge Optimization in T1D (TeKnO T1D).,"OBJECTIVE


We explored the impact of TeKnO T1D, an online, case-based, spaced education curriculum about insulin pump and continuous glucose monitor (CGM) use in pediatric type 1 diabetes management.
METHODS


Pediatric endocrinology fellows (n = 64) were randomized to receive an educational curriculum focused on either insulin pumps or CGMs. Fellows received interactive questions twice weekly via email or mobile app. Median time to completion was 76.5 days. The primary outcome was change in knowledge as measured by performance on multiple-choice questions (MCQ) from the pre-test to the post-test.
RESULTS


Forty-eight of 64 (75%) learners completed the curriculum and assessments. The pump group improved from 35.0 ± 15% on the pre-test MCQs to 61.1 ± 17% on the post-test, a 12.2 absolute percentage point greater improvement on pump-specific items than the CGM group (P = .03). The CGM group improved from 30.3 ± 15% on the pre-test MCQs to 61.4 ± 21% on the post-test, a 28.7 absolute percentage point greater improvement on CGM-specific items than the pump group (P < .001). Both groups were more likely to report an appropriate level of understanding of their respective technologies after completing the corresponding curriculum. In thematic analysis of qualitative data, fellows indicated that knowledge gains led to improved patient care. There was universal agreement about enjoyment and effectiveness of the curricula.
CONCLUSIONS


TeKnO T1D proved to be an engaging, effective way to improve endocrinology fellows' knowledge and confidence about insulin pumps and CGM use in the management of pediatric type 1 diabetes.",2020,"T1D proved to be an engaging, effective way to improve endocrinology fellows' knowledge and confidence about insulin pumps and CGM use in the management of pediatric type 1 diabetes.","['Pediatric endocrinology fellows (n\xa0=\xa064', 'T1D', 'pediatric type 1 diabetes management', 'Forty-eight of 64 (75']","['CGM', 'insulin pump and continuous glucose monitor (CGM', 'educational curriculum focused on either insulin pumps or CGMs', 'interactive questions twice weekly via email or mobile app', 'Insulin Pumps and Continuous Glucose Monitors with Online Spaced Education']","['Median time to completion', 'CGM-specific items', 'pump-specific items', 'change in knowledge as measured by performance on multiple-choice questions (MCQ']","[{'cui': 'C1658521', 'cui_str': 'Pediatric endocrinology'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]",64.0,0.0403653,"T1D proved to be an engaging, effective way to improve endocrinology fellows' knowledge and confidence about insulin pumps and CGM use in the management of pediatric type 1 diabetes.","[{'ForeName': 'Brynn E', 'Initials': 'BE', 'LastName': 'Marks', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Waldman', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Reardon', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Terrio', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Anshul', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'MGH Institute of Health Professions, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Diane E J', 'Initials': 'DEJ', 'LastName': 'Stafford', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Katharine C', 'Initials': 'KC', 'LastName': 'Garvey', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Joseph I', 'Initials': 'JI', 'LastName': 'Wolfsdorf', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}]",Pediatric diabetes,['10.1111/pedi.13010']
327,31894578,Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate.,"OBJECTIVES


To evaluate cutaneous allergic reactions in clinical trials of adjunctive eslicarbazepine acetate (ESL) for focal seizures.
MATERIALS AND METHODS


Data were analyzed from three phase III randomized, double-blind, placebo-controlled studies of adjunctive ESL in adults (placebo, n = 426; ESL, n = 1021) and two randomized, double-blind, placebo-controlled studies (and open-label extensions [OLEs]) of adjunctive ESL in children aged 4-17 years (placebo, n = 160; ESL, n = 202; OLE, n = 337).
RESULTS


Adult studies: Rash (ESL 1.9%, placebo 0.9%) and pruritus (ESL 1.2%, placebo 0.9%) were the most frequent rash-related treatment-emergent adverse events (TEAEs). Most rash-related TEAEs were mild or moderate in severity. Incidence of rash increased with increasing ESL dose, but was not higher for patients who initiated treatment with higher ESL doses. Pediatric studies: Allergic dermatitis (ESL 3.0%, placebo 0) and rash (controlled studies: ESL 1.0%, placebo 1.3%; OLE periods: ESL ≤1.2%) were the most frequent rash-related TEAEs. There was one case of DRESS in the ESL group. Most rash-related TEAEs were mild or moderate in severity and judged as not related to treatment with ESL.
CONCLUSIONS


Serious skin rashes were rare during adult and pediatric clinical trials of ESL. Although the incidence of rash with ESL was low, it is important for patients/caregivers to be made aware of the potential signs and symptoms associated with serious skin rashes.",2020,"Incidence of rash increased with increasing ESL dose, but was not higher for patients who initiated treatment with higher ESL doses.","['in adults (placebo, n = 426; ESL, n = 1021', 'children aged 4-17 years (placebo, n = 160; ESL, n = 202; OLE, n = 337']","['placebo-controlled studies (and open-label extensions [OLEs]) of adjunctive ESL', 'adjunctive ESL', 'placebo', 'adjunctive eslicarbazepine acetate (ESL', 'eslicarbazepine acetate']","['Incidence of rash', 'pruritus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2725262', 'cui_str': 'eslicarbazepine acetate'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",1021.0,0.559034,"Incidence of rash increased with increasing ESL dose, but was not higher for patients who initiated treatment with higher ESL doses.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Rogin', 'Affiliation': 'Midwest Center for Seizure Disorders, Minneapolis Clinic of Neurology, Golden Valley, MN, USA.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Resnick', 'Affiliation': ""Department of Neurology, Nicklaus Children's Hospital, Florida International University, Miami, FL, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Strom', 'Affiliation': 'Department of Neurology, University of Colorado Denver Health Sciences, Aurora, CO, USA.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Sahlgrenska Academy Institute of Neuroscience and Physiology, Goteborg, Sweden.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Kochen', 'Affiliation': 'Neurosciences and Complex Systems Unit (ENyS), Epilepsy Section, CONICET, Hospital El Cruce ""N. Kirchner"", University National A. Jauretche (UNAJ), University Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gama', 'Affiliation': 'BIAL - Portela & Ca, S.A., S. Mamede do Coronado, Portugal.'}, {'ForeName': 'Patrício', 'Initials': 'P', 'LastName': 'Soares-da-Silva', 'Affiliation': 'BIAL - Portela & Ca, S.A., S. Mamede do Coronado, Portugal.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",Acta neurologica Scandinavica,['10.1111/ane.13218']
328,31564432,"A Randomized, Controlled Trial of the Analytic and Diagnostic Performance of Singleton and Trio, Rapid Genome and Exome Sequencing in Ill Infants.","The second Newborn Sequencing in Genomic Medicine and Public Health study was a randomized, controlled trial of the effectiveness of rapid whole-genome or -exome sequencing (rWGS or rWES, respectively) in seriously ill infants with diseases of unknown etiology. Here we report comparisons of analytic and diagnostic performance. Of 1,248 ill inpatient infants, 578 (46%) had diseases of unknown etiology. 213 infants (37% of those eligible) were enrolled within 96 h of admission. 24 infants (11%) were very ill and received ultra-rapid whole-genome sequencing (urWGS). The remaining infants were randomized, 95 to rWES and 94 to rWGS. The analytic performance of rWGS was superior to rWES, including variants likely to affect protein function, and ClinVar pathogenic/likely pathogenic variants (p < 0.0001). The diagnostic performance of rWGS and rWES were similar (18 diagnoses in 94 infants [19%] versus 19 diagnoses in 95 infants [20%], respectively), as was time to result (median 11.0 versus 11.2 days, respectively). However, the proportion diagnosed by urWGS (11 of 24 [46%]) was higher than rWES/rWGS (p = 0.004) and time to result was less (median 4.6 days, p < 0.0001). The incremental diagnostic yield of reflexing to trio after negative proband analysis was 0.7% (1 of 147). In conclusion, rapid genomic sequencing can be performed as a first-tier diagnostic test in inpatient infants. urWGS had the shortest time to result, which was important in unstable infants, and those in whom a genetic diagnosis was likely to impact immediate management. Further comparison of urWGS and rWES is warranted because genomic technologies and knowledge of variant pathogenicity are evolving rapidly.",2019,"The diagnostic performance of rWGS and rWES were similar (18 diagnoses in 94 infants [19%] versus 19 diagnoses in 95 infants [20%], respectively), as was time to result (median 11.0 versus 11.2 days, respectively).","['Ill Infants', 'seriously ill infants with diseases of unknown etiology', '1,248 ill inpatient infants, 578 (46%) had diseases of unknown etiology', 'inpatient infants', '213 infants (37% of those eligible) were enrolled within 96\xa0h of admission', '24 infants (11%) were very ill and received ultra-rapid whole-genome sequencing (urWGS']","['rapid whole-genome or -exome sequencing (rWGS or rWES', 'urWGS and rWES']",['diagnostic performance of rWGS and rWES'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3640076', 'cui_str': 'Complete Genome Sequencing'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C3178814', 'cui_str': 'Exome'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",1248.0,0.162985,"The diagnostic performance of rWGS and rWES were similar (18 diagnoses in 94 infants [19%] versus 19 diagnoses in 95 infants [20%], respectively), as was time to result (median 11.0 versus 11.2 days, respectively).","[{'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Kingsmore', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA. Electronic address: skingsmore@rchsd.org.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Cakici', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Gaughran', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Feddock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Batalov', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Bainbridge', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Caylor', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Clarke', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Ellsworth', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Lauge', 'Initials': 'L', 'LastName': 'Farnaes', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Hildreth', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA; Department of Pediatrics, University of Washington, Seattle, WA 98195, USA.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hobbs', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Kiely', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Cyrielle I', 'Initials': 'CI', 'LastName': 'Kint', 'Affiliation': 'Diploid, 3001 Leuven, Belgium.'}, {'ForeName': 'Jerica', 'Initials': 'J', 'LastName': 'Lenberg', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Shareef', 'Initials': 'S', 'LastName': 'Nahas', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Prince', 'Affiliation': 'Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Reyes', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Salz', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sanford', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schols', 'Affiliation': 'Diploid, 3001 Leuven, Belgium.'}, {'ForeName': 'Nathaly', 'Initials': 'N', 'LastName': 'Sweeney', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Tokita', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Narayanan', 'Initials': 'N', 'LastName': 'Veeraraghavan', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Watkins', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Wigby', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Wong', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Shimul', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'Meredith S', 'Initials': 'MS', 'LastName': 'Wright', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dimmock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of human genetics,['10.1016/j.ajhg.2019.08.009']
329,32237279,"A new model of care and in-house general practitioners for residential aged care facilities: a stepped wedge, cluster randomised trial.","OBJECTIVES


To evaluate whether an alternative model of care in aged care facilities, including in-house general practitioners, influenced health outcomes for residents.
DESIGN


Stepped wedge, cluster randomised controlled trial over 90 weeks (31 December 2012 - 21 September 2014), with a 54-week pre-trial retrospective data period (start: 19 December 2011) and a 54-week post-trial prospective data collection period (to 4 October 2015).
PARTICIPANTS, SETTING


Fifteen residential aged care facilities operated by Bupa Aged Care in metropolitan and regional cities in four Australian states.
INTERVENTION


Residential aged care facilities sought to recruit general practitioners as staff members; care staff roles were redefined to allow registered nurses greater involvement in care plan development.
MAIN (PRIMARY) OUTCOME MEASURES


Numbers of falls; numbers of unplanned transfers to hospital; polypharmacy.
RESULTS


The new model of care could be implemented in all facilities, but four could not recruit in-house GPs at any time during the trial period. Intention-to-treat analyses found no statistically significant effect of the intervention on the primary outcome measures. Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
CONCLUSIONS


Recruiting GPs to work directly in residential aged care facilities is difficult, but may reduce the burden of unplanned presentations to hospitals and increase the reporting of adverse events.
TRIAL REGISTRATION


Australia New Zealand Clinical Trial Registry, ACTRN12613000218796 (25 February 2013).",2020,"Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
","['90 weeks (31 December 2012 - 21 September 2014), with a 54-week pre-trial retrospective data period (start: 19 December 2011) and a 54-week post-trial prospective data collection period (to 4 October 2015', 'Fifteen residential aged care facilities operated by Bupa Aged Care in metropolitan and regional cities in four Australian states', 'residential aged care facilities', 'house general practitioners for residential aged care facilities', 'aged care facilities, including in-house general practitioners, influenced health outcomes for residents']",['Residential aged care facilities sought to recruit general practitioners as staff members; care staff roles were redefined to allow registered nurses greater involvement in care plan development'],"['Numbers of falls; numbers of unplanned transfers to hospital; polypharmacy', 'numbers of unplanned hospital transfers']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}]",,0.299138,"Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
","[{'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Palmer', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Tierney', 'Affiliation': 'Bupa Aged Care Australia, Sydney, NSW.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Robinson', 'Affiliation': 'Wicking Dementia Research and Education Centre, University of Tasmania, Hobart, TAS.'}]",The Medical journal of Australia,['10.5694/mja2.50565']
330,31429207,"The effect of inspiratory muscle training on fatigue and dyspnea in patients with heart failure: A randomized, controlled trial.","AIM


Fatigue and dyspnea are debilitating symptoms in patients with heart failure (HF). The purpose of this study was to evaluate the effects of inspiratory muscle training (IMT) on dyspnea, fatigue and the New York Heart Association (NYHA) functional classification in patients with HF.
METHODS


In this prospective, randomized, controlled trial, 84 patients with HF (NYHA classes II-III/IV) with a mean age of 56.62 ± 9.56 years were randomly assigned to a 6-week IMT (n = 42) or a sham IMT (n = 42) program. The IMT was performed at 40% of the maximal inspiratory pressure (MIP) in the IMT group and at 10% in the sham group. The main outcomes were assessed at baseline and after the intervention and included dyspnea severity scale (Modified Medical Research Council [MMRC], Fatigue Severity Scale [FSS] and the NYHA functional classification (based on the presenting symptoms).
RESULTS


The between-group analysis showed significant improvements in dyspnea, fatigue and the NYHA functional classification in the IMT group compared to the sham group (P < .05). The within-group analysis showed significant improvements in dyspnea (from 2.63 ± 0.79 to 1.38 ± 0.66, P < .001), fatigue (from 43.36 ± 8.5 to 28.95 ± 9.11, P < .001) and the NYHA functional classification (from 2.73 ± 0.5 to 2.1 ± 0.6, P = .001) in the IMT group, while fatigue and dyspnea increased significantly in the sham group.
CONCLUSIONS


The 6-week home-based IMT was found to be an effective and safe tool for reducing dyspnea and fatigue and improving the NYHA functional classification.",2020,The 6-week home-based IMT was found to be an effective and safe tool for reducing dyspnea and fatigue and improving the NYHA functional classification.,"['patients with heart failure (HF', '84 patients with HF (NYHA classes II-III/IV) with a mean age of 56.62\u2009± 9.56\u2009years', 'patients with HF.\nMETHODS', 'patients with heart failure']","['inspiratory muscle training (IMT', 'IMT', 'sham IMT', 'inspiratory muscle training']","['fatigue', 'NYHA functional classification', 'maximal inspiratory pressure (MIP', 'dyspnea', 'fatigue and dyspnea', 'dyspnea, fatigue and the New York Heart Association (NYHA) functional classification', 'dyspnea severity scale (Modified Medical Research Council [MMRC], Fatigue Severity Scale [FSS] and the NYHA functional classification (based on the presenting symptoms', 'dyspnea, fatigue and the NYHA functional classification']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",84.0,0.0525462,The 6-week home-based IMT was found to be an effective and safe tool for reducing dyspnea and fatigue and improving the NYHA functional classification.,"[{'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Hossein Pour', 'Affiliation': 'Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'School of Nursing and Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Saki', 'Affiliation': 'Social Determinants of Health Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Birjandi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health and Nutrition, Lorestan University of Medical Sciences, Khorramabad, Iran.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12290']
331,31465156,Effects of Tai Chi therapy on body mass index and physical index of intellectual disability.,"AIM


Continuous program development and application are necessary in order to manage the health and address the problems of secondary metabolic disorders for people with intellectual disabilities. This study examines the effects of Tai Chi therapy on body mass index (BMI) and physical index among people with intellectual disabilities.
METHODS


A quasi-experimental study using a pretest-post-test control group, non-synchronized design was employed. Samples were in total 104 people with intellectual disabilities (experimental: n = 67, control: n = 37) in two facilities in South Korea. They were randomly allocated using a coin toss into the two groups. Tai Chi therapy as an experimental intervention was the Sun style Tai Chi exercise, which consists of the warm-up (5 min), main exercise (45 min), and finishing (meditation, 10 min). Tai Chi therapy was conducted twice a week for a total of 40 sessions for 5 months (1 hour each) by one professional instructor. Measures were general characteristics of study participants, BMI as degree of obesity, and physical index. Data were analyzed using the SPSS 21.0 program (descriptive statistics, χ 2  test, independent t test). A P value of less than .05 was considered statistically significant.
RESULTS


There were statistically significant differences on fasting blood glucose (t = 4.351, P < .001) and high-density lipoprotein (t = -2.052, P = .043) in the physical index between the two groups.
CONCLUSIONS


Tai Chi therapy was an effective intervention for decreasing fasting blood glucose and for increasing high-density lipoprotein in those with intellectual disabilities. Tai Chi therapy can be implied as a nursing intervention for intellectual disabilities in nursing practice.",2020,"There were statistically significant differences on fasting blood glucose (t = 4.351, P < .001) and high-density lipoprotein (t = -2.052, P = .043) in the physical index between the two groups.
","['intellectual disabilities in nursing practice', '104 people with intellectual disabilities (experimental: n = 67, control: n = 37) in two facilities in South Korea', 'people with intellectual disabilities']",['Tai Chi therapy'],"['high-density lipoprotein', 'body mass index and physical index of intellectual disability', 'fasting blood glucose', 'BMI as degree of obesity, and physical index', 'body mass index (BMI) and physical index']","[{'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",104.0,0.0252442,"There were statistically significant differences on fasting blood glucose (t = 4.351, P < .001) and high-density lipoprotein (t = -2.052, P = .043) in the physical index between the two groups.
","[{'ForeName': 'Nam-Hyun', 'Initials': 'NH', 'LastName': 'Cha', 'Affiliation': 'Department of Nursing, Andong National University, Andong-si, South Korea.'}, {'ForeName': 'Ga-Eul', 'Initials': 'GE', 'LastName': 'Jeon', 'Affiliation': 'Department of Nursing, Cheongam College, Suncheon-si, South Korea.'}, {'ForeName': 'Youngmi', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': 'Department of Nursing, Graduate School, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Sohyune R', 'Initials': 'SR', 'LastName': 'Sok', 'Affiliation': 'Department of Nursing, College of Nursing Science, Kyung Hee University, Seoul, South Korea.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12292']
332,32218471,Pre-operative intravitreal dexamethasone implant in patients with refractory diabetic macular edema undergoing cataract surgery.,"To examine preoperative use of intravitreal dexamethasone implant in patients with refractory diabetic macular edema (DME) undergoing cataract surgery. Participants in this study were 17 patients with DME refractory to previous treatment with anti-vascular endothelial growth factor agents or dexamethasone implant, and co-existent cataract. All participants received intravitreal dexamethasone implant at baseline and underwent phacoemulsification within one month after its insertion. Best-corrected visual acuity (BCVA) and central subfield thickness (CST) changes between baseline, time of cataract surgery and postoperative months 1, 2 and 3 were evaluated. At month 1 after surgery, BCVA improved significantly from 42.3 ± 9.6 to 58.7 ± 11.9 letters compared to baseline (p < 0.001) and the improvement was sustained at month 2 and month 3 postoperatively. One month postoperatively, CST improved significantly compared to baseline (p < 0.001) and the improvement was sustained at month 2 (p < 0.001), while at month 3 CST started to increase, but remained significantly lower than baseline (p = 0.003). At month 3 postoperatively, 35.3% of patients presented recurrence of ME. Patients with refractory DME and cataract can safely undergo phacoemulsification when dexamethasone implant is inserted one month prior to surgery to ensure adequate control of postoperative inflammation and prevent deterioration of ME.",2020,"One month postoperatively, CST improved significantly compared to baseline (p < 0.001) and the improvement was sustained at month 2 (p < 0.001), while at month 3 CST started to increase, but remained significantly lower than baseline (p = 0.003).","['17 patients with DME refractory to previous treatment with anti-vascular endothelial growth factor agents or dexamethasone implant, and co-existent cataract', 'patients with refractory diabetic macular edema (DME) undergoing cataract surgery', 'patients with refractory diabetic macular edema undergoing cataract surgery', 'Patients with refractory DME and cataract']","['intravitreal dexamethasone', 'dexamethasone', 'Pre-operative intravitreal dexamethasone implant', 'intravitreal dexamethasone implant']","['Best-corrected visual acuity (BCVA) and central subfield thickness (CST) changes', 'BCVA', 'recurrence of ME']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",17.0,0.0262164,"One month postoperatively, CST improved significantly compared to baseline (p < 0.001) and the improvement was sustained at month 2 (p < 0.001), while at month 3 CST started to increase, but remained significantly lower than baseline (p = 0.003).","[{'ForeName': 'Stamatina A', 'Initials': 'SA', 'LastName': 'Kabanarou', 'Affiliation': 'Department of Ophthalmology, Korgialenio-Benakio Hospital, Athens, Greece. stamatina_k@hotmail.com.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Xirou', 'Affiliation': 'Department of Ophthalmology, Korgialenio-Benakio Hospital, Athens, Greece.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Boutouri', 'Affiliation': 'Department of Ophthalmology, Korgialenio-Benakio Hospital, Athens, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Gkizis', 'Affiliation': 'Department of Ophthalmology, Korgialenio-Benakio Hospital, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Vasilias', 'Affiliation': 'Department of Ophthalmology, Korgialenio-Benakio Hospital, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Bontzos', 'Affiliation': 'Department of Ophthalmology, Korgialenio-Benakio Hospital, Athens, Greece.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Chatziralli', 'Affiliation': '2nd Department of Ophthalmology, University of Athens, Athens, Greece.'}]",Scientific reports,['10.1038/s41598-020-62561-3']
333,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
334,32239442,Are Videos or Text Better for Describing Attributes in Stated-Preference Surveys?,"OBJECTIVE


In stated-preference research, the conventional approach to describing study attributes is through text, often with easy-to-understand graphics. More recently, researchers have begun to present attribute descriptions and content in videos. Some experts have expressed concern regarding internalization and retention of information conveyed via video.
OBJECTIVE


Our study aimed to compare respondents' understanding of attribute information provided via text versus video.
METHODS


Potential respondents were randomized to receive a text or video version of the survey. In the text version, all content was provided in text format along with still graphics. In the video version, text content was interspersed with four video clips, providing the same information as the text version. In both versions, 10 questions were embedded to assess respondents' understanding of the information presented relating to ovarian cancer treatments. Half of the questions were on treatment benefits and the other half were on treatment-related risks. Some questions asked about the decision context and definitions of treatment features, and others asked about the graphic presentation of treatment features. Preferences for ovarian cancer treatments were also compared between respondents receiving text versus video versions.
RESULTS


Overall, 150 respondents were recruited. Of the 95 who were eligible and completed the survey, 54 respondents received the text version and 41 received the video version. Median times to completion were 24 and 30 min in the video and text arms, respectively (p < 0.01). Both groups spent an average of 35 min completing the survey. On the first comprehension question, 43% in the text arm and 61% in the video arm provided the correct response (p = 0.08). Although the mean number of correct responses was significantly higher in the video versus text arms (9.1 vs. 8.6, p = 0.02), there were no systematic differences in preferences between arms.
CONCLUSIONS


The quality of stated-preference data relies on respondents' understanding of study content. Information provided via video may better engage survey participants and improve their retention of content.",2020,"Median times to completion were 24 and 30 min in the video and text arms, respectively (p < 0.01).","['150 respondents were recruited', 'Of the 95 who were eligible and completed the survey, 54 respondents received the', 'Potential respondents']",['text version and 41 received the video version'],"['mean number of correct responses', 'Median times to completion', 'correct response']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",150.0,0.0611263,"Median times to completion were 24 and 30 min in the video and text arms, respectively (p < 0.01).","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jui-Chen', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Ehrisman', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Havrilesky', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA. shelby.reed@duke.edu.'}]",The patient,['10.1007/s40271-020-00416-9']
335,32232434,A posture and mobility training package for care home staff: results of a cluster randomised controlled feasibility trial (the PATCH trial).,"BACKGROUND


provision of care for care home residents with complex needs is challenging. Physiotherapy and activity interventions can improve well-being but are often time-limited and resource intensive. A sustainable approach is to enhance the confidence and skills of staff who provide care. This trial assessed the feasibility of undertaking a definitive evaluation of a posture and mobility training programme for care staff.
DESIGN AND SETTING


a cluster randomised controlled feasibility trial with embedded process evaluation. Ten care homes in Yorkshire, United Kingdom, were randomised (1:1) to the skilful care training package (SCTP) or usual care (UC).
PARTICIPANTS


residents who were not independently mobile.
INTERVENTION


SCTP-delivered by physiotherapists to care staff.
OBJECTIVES AND MEASUREMENTS


key objectives informed progression to a definitive trial. Recruitment, retention and intervention uptake were monitored. Data, collected by a blinded researcher, included pain, posture, mobility, hospitalisations and falls. This informed data collection feasibility and participant safety.
RESULTS


a total of 348 residents were screened; 146 were registered (71 UC, 75 SCTP). Forty two were lost by 6 months, largely due to deaths. While data collection from proxy informants was good (>95% expected data), attrition meant that data completion rates did not meet target. Data collection from residents was poor due to high levels of dementia. Intervention uptake was variable-staff attendance at all sessions ranged from 12.5 to 65.8%. There were no safety concerns.
CONCLUSION


care home and resident recruitment are feasible, but refinement of data collection approaches and intervention delivery are needed for this trial and care home research more widely.",2020,"There were no safety concerns.
","['residents who were not independently mobile', 'a total of 348 residents were screened; 146 were registered (71 UC, 75 SCTP', 'Ten care homes in Yorkshire, United Kingdom', 'care home staff']","['posture and mobility training package', 'posture and mobility training programme', 'skilful care training package (SCTP) or usual care (UC', 'Physiotherapy and activity interventions']","['pain, posture, mobility, hospitalisations and falls', 'Recruitment, retention and intervention uptake']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",348.0,0.13646,"There were no safety concerns.
","[{'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Graham', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ellwood', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hull', 'Affiliation': 'Leeds Neurophysiotherapy, Leeds, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'Leeds Neurophysiotherapy, Leeds, UK.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Cundill', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holland', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Goodwin', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clarke', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hawkins', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Health Economics Group, Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Patel', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.'}]",Age and ageing,['10.1093/ageing/afaa046']
336,28810394,Adapting evidence-based behavioral weight loss programs for emerging adults: A pilot randomized controlled trial.,"Emerging adults are at high risk of obesity but behavioral weight loss programs do not meet their needs. Emerging adults ( N = 52, age = 22.3 ± 2 years, body mass index = 34.2 ± 5.5 kg/m 2 , 46.2% non-Hispanic White) were randomly assigned to one of three behavioral weight loss programs adapted based on formative work: face-to-face behavioral weight loss, web-based behavioral weight loss, or web plus optional community sessions (Hybrid). Assessments occurred at 0 and 3 months. Engagement and self-monitoring were highest in Hybrid. Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid. Percent achieving ⩾5 percent weight loss was highest in Hybrid (63%). Findings suggest potential for adapted behavioral weight loss to promote engagement and weight loss in emerging adults.",2019,"Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid.","['Emerging adults ( N\u2009=\u200952, age\u2009=\u200922.3\u2009±\u20092\u2009years, body mass index\u2009=\u200934.2\u2009±\u20095.5\u2009kg/m 2 , 46.2% non-Hispanic White', 'emerging adults']","['behavioral weight loss programs adapted based on formative work: face-to-face behavioral weight loss, web-based behavioral weight loss, or web plus optional community sessions (Hybrid']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0311466,"Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid.","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': '2 The University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': '3 The Miriam Hospital, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': '3 The Miriam Hospital, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Blumenthal', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Caccavale', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': '3 The Miriam Hospital, USA.'}]",Journal of health psychology,['10.1177/1359105316688951']
337,30855082,Cost of behavioral weight loss programs implemented in clinical practice: The POWER trial at Johns Hopkins.,"Obesity presents an important public health problem that affects more than a third of the U.S. adult population and that is associated with increased morbidity, mortality, and costs. Previously, we documented that two primary care-based weight loss interventions were clinically effective. To encourage the implementation of and reimbursement for these interventions, we evaluated their relative cost-effectiveness. We performed a cost analysis of the Practice-based Opportunities for Weight Reduction (POWER) trial, a three-arm trial that enrolled 415 patients with obesity from six primary care practices. Trial participants were randomized to a control arm, an in-person support intervention, or a remote support intervention; in the two intervention arms, behavioral interventions were delivered over 24 months, in two phases. Weight loss was measured at 6, 12, and 24 months. Using timesheets and empirical data, we evaluated the cost of the in-person and remote support interventions from the perspective of a health care system delivering the interventions. A univariate sensitivity analysis was conducted to evaluate uncertainty around model assumptions. All comparisons were tested using independent t-tests. Cost of the in-person intervention was higher at 6 months ($113 per participant per month and $117 per kg lost) than the remote support intervention ($101 per participant per month and $99 per kg lost; p < .001). Costs were also higher for the in-person support intervention at 24 months ($73 per participant per month and $342 per kg lost) than for the remote support intervention ($53 per participant per month and $275 per kg lost; p < .001). In the sensitivity analyses, cost ranged from $274/kg lost to $456/kg lost for the in-person support intervention and from $218/kg to $367/kg lost for the remote support intervention. A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention. Expanding the scope of reimbursable programs to include other cost-effective interventions could help ensure that a broader range of patients receive the type of support needed.",2020,A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention.,['enrolled 415 patients with obesity from six primary care practices'],"['person support intervention, or a remote support intervention']","['Weight loss', 'morbidity, mortality, and costs', 'Costs', 'Cost of the in-person intervention', 'cost-effective']","[{'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",415.0,0.0839127,A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention.,"[{'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nowella', 'Initials': 'N', 'LastName': 'Durkin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Louis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Frick', 'Affiliation': 'Johns Hopkins Carey Business School, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby120']
338,32229754,Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial.,"BACKGROUND


Postdischarge nausea and vomiting after ambulatory surgery is a common problem that is not adequately addressed in current practice. This prospective, randomized, double-blind, parallel-group, placebo-controlled study was designed to test the hypothesis that oral olanzapine is superior to placebo at preventing postdischarge nausea and vomiting.
METHODS


In a single-center, double-blind, randomized, placebo-controlled trial, the authors compared a single preoperative dose of olanzapine 10 mg to placebo, in adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and ondansetron. The primary composite outcome was nausea and/or vomiting in the 24 h after discharge. Secondary outcomes included severe nausea, vomiting, and side effects.
RESULTS


A total of 140 patients were randomized and evaluable. The primary outcome occurred in 26 of 69 patients (38%) in the placebo group and in 10 of 71 patients (14%) in the olanzapine group (relative risk, 0.37; 95% CI, 0.20 to 0.72; P = 0.003). Severe nausea occurred in 14 patients (20%) in the placebo group and 4 patients (6%) in the olanzapine group (relative risk, 0.28; 95% CI, 0.10 to 0.80). Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10). The median score for sedation (scale 0 to 10, with 10 being highest) in the 24 h after discharge was 4 (interquartile range, 2 to 7) in the placebo group and 6 (interquartile range, 3 to 8) in the olanzapine group (P = 0.023).
CONCLUSIONS


When combined with ondansetron and dexamethasone, the addition of olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 hafter discharge from ambulatory surgery by about 60% with a slight increase in reported sedation.",2020,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","['140 patients were randomized and evaluable', 'after Ambulatory Surgery', 'adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia']","['dexamethasone and ondansetron', 'Olanzapine', 'placebo', 'olanzapine 10 mg to placebo', 'olanzapine', 'ondansetron and dexamethasone']","['Severe nausea', 'Postdischarge Nausea and Vomiting', 'nausea and vomiting', 'postdischarge nausea and vomiting', 'Vomiting', 'risk of nausea and/or vomiting', 'median score for sedation', 'severe nausea, vomiting, and side effects', 'nausea and/or vomiting']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",140.0,0.74613,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","[{'ForeName': 'Jaime B', 'Initials': 'JB', 'LastName': 'Hyman', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine (J.B.H., C.P., B.C., M.H., S.D.) Department of Population Health Science and Policy (H.-M.L.) Division of Gynecology, Department of Obstetrics, Gynecology and Reproductive Science (L.R., R.L.B.G., V.P., C.A.-W.) Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Blavatnik Family Women's Health Research Institute (S.V.B.) Division of Plastic and Reconstructive Surgery, Department of Surgery (P.J.T.), Icahn School of Medicine at Mount Sinai, New York, New York Suzanne Fenske, M.D., P.C., Brookville, New York (S.S.F.) Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts (S.B.P.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hung-Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Fenske', 'Affiliation': ''}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Barr Grzesh', 'Affiliation': ''}, {'ForeName': 'Stephanie V', 'Initials': 'SV', 'LastName': 'Blank', 'Affiliation': ''}, {'ForeName': 'Sylvie B', 'Initials': 'SB', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hartnett', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Taub', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Palvia', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'DeMaria', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ascher-Walsh', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003286']
339,32200585,Effect of diet and diet combined with chronic aerobic exercise on chemerin plasma concentrations and adipose tissue in obese women.,"OBJECTIVE


Chemerin concentrations are elevated in obesity and associated with inflammation and insulin resistance. Exercise improves insulin sensitivity, which may be facilitated by changes in chemerin. We explored the effects of 24 -week aerobic exercise program, diet and both combined on serum and abdominal adipose tissue (AT) chemerin, and adiponectin concentrations in obese women.
METHODS


Thirty volunteers participated in a 24-week intervention whereby the women were randomly categorised into three groups: 1) exercise (EX), 2) diet (DI) and 3) exercise and diet group (EXD). Blood samples were taken before and after 12-week and 24-week of the intervention. Adipose Tissue (AT) biopsies were gathered only at baseline and at the end of the experiment.
RESULTS


We found increases in VO2max in EXD (21.8 and 39.5%, p < 0.05) and in the EX group (18.1 and 41%, p < 0.05) after the 12 and 24-week training, respectively. Chemerin circulating levels were reduced in EXD and DI groups, after 24-week training program (p < 0.01). HOMA-R decreased only in the EXD group (p < 0.05). However, circulating adiponectin increased in both EXD and DI groups after 24-week training (p < 0.01). After 6 months training, AT biopsies showed decreases in chemerin levels in EXD and DI groups (p < 0.01). No changes in AT biopsies were observed in EX group. Nevertheless, adiponectin increased (p < 0.05) in AT.
CONCLUSION


Aerobic training and diet, whether applied exclusively or combined have an impact on circulating or AT levels of adiponectin and chemerin in to the exclusion of the EX group. Therefore The 24-week training program and diet used in this study was very effective for producing significant benefits to body composition, insulin resistance and lipids profile, as well as lowering chemerin levels in these obese women. Therefore, our data suggests that chemerin serum concentrations are associated with insulin resistance.",2019,"Chemerin circulating levels were reduced in EXD and DI groups, after 24-week training program (p < 0.01).","['obese women', 'Thirty volunteers participated in a 24-week intervention whereby the women were randomly categorised into three groups: 1']","['exercise (EX), 2) diet (DI) and 3) exercise and diet group (EXD', 'Aerobic training and diet', '24 -week aerobic exercise program, diet and both combined', 'EXD', 'diet and diet combined with chronic aerobic exercise']","['chemerin levels', 'insulin sensitivity', 'circulating adiponectin', 'chemerin plasma concentrations and adipose tissue', 'Adipose Tissue (AT) biopsies', 'HOMA-R', 'adiponectin', 'serum and abdominal adipose tissue (AT) chemerin, and adiponectin concentrations', 'Chemerin circulating levels', 'VO2max in EXD']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0117028', 'cui_str': 'EXD'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0117028', 'cui_str': 'EXD'}]",30.0,0.0131555,"Chemerin circulating levels were reduced in EXD and DI groups, after 24-week training program (p < 0.01).","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Lakhdar', 'Affiliation': 'Laboratory of cardio-circulatory, respiratory, metabolic and hormonal adaptations to muscular exercise, Faculty of Medicine, Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Landolsi', 'Affiliation': 'Laboratory of cardio-circulatory, respiratory, metabolic and hormonal adaptations to muscular exercise, Faculty of Medicine, Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Ezddine', 'Initials': 'E', 'LastName': 'Bouhlel', 'Affiliation': 'Laboratory of cardio-circulatory, respiratory, metabolic and hormonal adaptations to muscular exercise, Faculty of Medicine, Ibn El Jazzar, Sousse, Tunisia.'}, {'ForeName': 'Zouhair', 'Initials': 'Z', 'LastName': 'Tabka', 'Affiliation': 'Laboratory of cardio-circulatory, respiratory, metabolic and hormonal adaptations to muscular exercise, Faculty of Medicine, Ibn El Jazzar, Sousse, Tunisia.'}]",Neuro endocrinology letters,[]
340,31728054,Randomized assessment of delayed intensification and two methods for parenteral methotrexate delivery in childhood B-ALL: Children's Oncology Group Studies P9904 and P9905.,"The delayed intensification (DI) enhanced outcome for patients with acute lymphoblastic leukemia (ALL) treated on BFM 76/79 and CCG 105 after a prednisone-based induction. Childrens Oncology Group protocols P9904/9905 evaluated DI via a post-induction randomization for eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients. A second randomization compared intravenous methotrexate (IV MTX) as a 24- (1 g/m 2 ) vs. 4-h (2 g/m 2 ) infusion. NCI SR patients received a dexamethasone-based three-drug and NCI HR/CNS 3 SR patients a prednisone-based four-drug induction. End induction MRD (minimal residual disease) was obtained but did not impact treatment. DI improved the 10-year continuous complete remission (CCR) rate; 75.5 ± 2.5% vs. 81.8 ± 2.2% p = 0.002, whereas MTX administration did not; 4-h 80.8 ± 1.9%; 24-h 81.4 ± 1.9% (p = 0.7780). Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209). MRD predicted outcome; 10-year CCR 87.7 ± 2.2 and 82.1 ± 2.5% when MRD was <0.01% with/without DI (p = 0.007) and 54.3 ± 8% and 44 ± 8% for patients with MRD ≥ 0.01% with/without DI (p = 0.11). DI improved CCR for patients with B-ALL with and without end induction MRD.",2020,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"['eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients', 'Childrens Oncology Group protocols', ""childhood B-ALL: Children's Oncology Group Studies P9904 and P9905"", 'patients with acute lymphoblastic leukemia (ALL) treated on']","['NCI SR', 'dexamethasone', 'MTX', 'BFM', 'intravenous methotrexate (IV MTX']","['Overall survival (OS', 'DI improved CCR', '10-year continuous complete remission']","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0328713,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA. naomi.winick@utsouthwestern.edu.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': 'Department of Health Outcomes and Policy, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology and Oncology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Paul Bowman', 'Affiliation': 'Department of Pediatrics, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Maine Children's Cancer Program, Scarborough, ME, USA.""}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Pullen', 'Affiliation': 'Department of Pediatrics, University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Willman', 'Affiliation': 'Cancer Center and Departments of Internal Medicine and Pathology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, and the Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and The Perlmutter Cancer Center, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Camitta', 'Affiliation': 'Department of Pediatrics, Midwest Center for Cancer and Blood Disorders, Medical College of Wisconsin, Milwaukee, WI, USA.'}]",Leukemia,['10.1038/s41375-019-0642-2']
341,31308004,A Randomized Phase II Trial of Pioglitazone for Lung Cancer Chemoprevention in High-Risk Current and Former Smokers.,"Lung cancer chemoprevention, especially in high-risk former smokers, has great potential to reduce lung cancer incidence and mortality. Thiazolidinediones prevent lung cancer in preclinical studies, and diabetics receiving thiazolidinediones have lower lung cancer rates which led to our double-blind, randomized, phase II placebo-controlled trial of oral pioglitazone in high-risk current or former smokers with sputum cytologic atypia or known endobronchial dysplasia. Bronchoscopy was performed at study entry and after completing 6 months of treatment. Biopsies were histologically scored, and primary endpoint analysis tested worst biopsy scores (Max) between groups; Dysplasia index (DI) and average score (Avg) changes were secondary endpoints. Biopsies also received an inflammation score. The trial accrued 92 subjects (47 pioglitazone, 45 placebo), and 76 completed both bronchoscopies (39 pioglitazone, 37 placebo). Baseline dysplasia was significantly worse for current smokers, and 64% of subjects had mild or greater dysplasia at study entry. Subjects receiving pioglitazone did not exhibit improvement in bronchial dysplasia. Former smokers treated with pioglitazone exhibited a slight improvement in Max, while current smokers exhibited slight worsening. While statistically significant changes in Avg and DI were not observed in the treatment group, former smokers exhibited a slight decrease in both Avg and DI. Negligible Avg and DI changes occurred in current smokers. A trend toward decreased Ki-67 labeling index occurred in former smokers with baseline dysplasia receiving pioglitazone. While pioglitazone did not improve endobronchial histology in this high-risk cohort, specific lesions showed histologic improvement, and further study is needed to better characterize responsive dysplasia.",2019,"While statistically significant changes in Avg and DI were not observed in the treatment group, former smokers exhibited a slight decrease in both Avg and DI.","['Lung Cancer Chemoprevention in High Risk Current and Former Smokers', 'smokers with sputum cytologic atypia or known endobronchial dysplasia', '92 subjects (47']","['thiazolidinediones', 'pioglitazone, 45 placebo', 'Thiazolidinediones', 'pioglitazone', 'bronchoscopies (39 pioglitazone, 37 placebo', 'Pioglitazone']","['bronchial dysplasia', 'Ki-67 labeling index', 'worst biopsy scores (Max) between groups; Dysplasia index (DI) and average score (Avg) changes', 'Avg and DI', 'endobronchial histology', 'Negligible Avg and DI changes', 'Baseline dysplasia']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0333865', 'cui_str': 'Atypical cell present'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}]","[{'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C1112356', 'cui_str': 'Bronchial dysplasia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0332269', 'cui_str': 'Negligible (qualifier value)'}]",92.0,0.146426,"While statistically significant changes in Avg and DI were not observed in the treatment group, former smokers exhibited a slight decrease in both Avg and DI.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Keith', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, Eastern Colorado VA Healthcare System, Rocky Mountain Regional VA Medical Center, Aurora, Colorado. Robert.keith@ucdenver.edu.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Blatchford', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Merrick', 'Affiliation': 'Division of Pathology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Bunn', 'Affiliation': 'Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Bagwell', 'Affiliation': 'Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Lori D', 'Initials': 'LD', 'LastName': 'Dwyer-Nield', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Jackson', 'Affiliation': 'Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Geraci', 'Affiliation': 'Department of Medicine, IU School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'York E', 'Initials': 'YE', 'LastName': 'Miller', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, Eastern Colorado VA Healthcare System, Rocky Mountain Regional VA Medical Center, Aurora, Colorado.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0006']
342,32078353,"Outreach and Inreach Strategies for Colorectal Cancer Screening Among Latinos at a Federally Qualified Health Center: A Randomized Controlled Trial, 2015-2018.","Objectives.  To compare usual care, inreach consisting of one-on-one education, mailed outreach offering a fecal immunochemical test (FIT), and a combination of outreach and inreach for promoting colorectal cancer (CRC) screening. Methods.  We conducted a 4-arm randomized controlled trial from 2015 to 2018 at a US federally qualified health center near the California-Mexico border primarily serving low-income Hispanics/Latinos. A total of 673 individuals aged 50 to 75 years not up to date with screening were assigned to 1 of the 4 intervention groups. The primary outcome was CRC screening through 6 months follow-up. Results.  A total of 671 patients were included in intention-to-screen analyses. Their mean age was 59.9 years, 48.9% were male, and 86.3% were primarily Spanish-speaking. Screening was 27.5% for usual care (95% confidence interval [CI] = 0.21, 0.34), 52.7% for inreach (95% CI = 0.45, 0.60), 77.2% for outreach (95% CI = 0.71, 0.83), and 78.9% for combination of inreach and outreach (95% CI = 0.73, 0.85;  P  < .001 for all comparisons except  P  = .793 for outreach vs combination). Conclusions.  Among individuals at high risk for noncompletion, inreach with one-on-one education nearly doubled, and outreach offering mailed FIT alone or in combination with inreach nearly tripled screening compared with usual care. Mailed FIT outreach was superior to inreach for promoting screening.",2020,"Screening was 27.5% for usual care (95% confidence interval [CI] = 0.21, 0.34), 52.7% for inreach (95% CI = 0.45, 0.60), 77.2% for outreach (95% CI = 0.71, 0.83), and 78.9% for combination of inreach and outreach (95% CI = 0.73, 0.85;  P  < .001 for all comparisons except  P  = .793 for outreach vs combination).","['Colorectal Cancer Screening Among Latinos at a Federally Qualified Health Center', '2015 to 2018 at a US federally qualified health center near the California-Mexico border primarily serving low-income Hispanics/Latinos', '2015-2018', '673 individuals aged 50 to 75 years not up to date with screening', '671 patients were included in intention-to-screen analyses', 'Their mean age was 59.9 years, 48.9% were male, and 86.3% were primarily Spanish-speaking']","['usual care, inreach consisting of one-on-one education, mailed outreach offering a fecal immunochemical test (FIT), and a combination of outreach and inreach']",['CRC screening through 6 months follow-up'],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",671.0,0.143398,"Screening was 27.5% for usual care (95% confidence interval [CI] = 0.21, 0.34), 52.7% for inreach (95% CI = 0.45, 0.60), 77.2% for outreach (95% CI = 0.71, 0.83), and 78.9% for combination of inreach and outreach (95% CI = 0.73, 0.85;  P  < .001 for all comparisons except  P  = .793 for outreach vs combination).","[{'ForeName': 'Sheila F', 'Initials': 'SF', 'LastName': 'Castañeda', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Balambal', 'Initials': 'B', 'LastName': 'Bharti', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Marielena', 'Initials': 'M', 'LastName': 'Rojas', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mercado', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Bearse', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Camacho', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Manuel Song', 'Initials': 'MS', 'LastName': 'Lopez', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Muñoz', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Shawne', 'Initials': 'S', 'LastName': ""O'Connell"", 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Talavera', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}]",American journal of public health,['10.2105/AJPH.2019.305524']
343,31455897,"Body weight, body composition and survival after 1 year: follow-up of a nutritional intervention trial in allo-HSCT recipients.","The role of body weight change in survival among recipients of hematopoietic stem-cell transplantation is controversial. We assessed the effect of optimizing energy and protein intake on 1-year survival, body weight and body composition, and the effect of body weight and body composition on 1-year survival in 117 patients (57 intervention, 60 control) in a randomized controlled trial. Cox regression was used to study effects of the intervention, weight and body composition on death, relapse, and nonrelapse mortality (NRM). We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90). Body weight, fat-free mass index, body fat mass index and total body water changed over time (p < 0.001), similarly in both groups (0.17 ≤ p ≤ 0.98). In multivariable analyses adjusted for group, gender and age, HRs and 95% CIs per one kilo increase in weight were 1.03 (1.01-1.06) and 1.04 (1.01-1.08) for death and NRM after 1 year (p ≤ 0.02), respectively, and 1.08 (1.01-1.15) for relapse after 3 months (p = 0.02). In conclusion, weight gain is possibly due to fluid retention and is an indicator of a complication in HSCT, rather than a marker of improved nutritional status.",2019,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","['allo-HSCT recipients', '117 patients (57 intervention, 60 control', 'recipients of hematopoietic stem-cell transplantation']",['optimizing energy and protein intake'],"['Body weight, body composition and survival', 'relapse', 'weight and body composition on death, relapse, and nonrelapse mortality (NRM', 'weight', 'Body weight, fat-free mass index, body fat mass index and total body water changed over time', 'weight gain', 'death and NRM', 'death hazard ratio', '1-year survival, body weight and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",117.0,0.156154,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Veierød', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lergenmuller', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}]",Bone marrow transplantation,['10.1038/s41409-019-0638-6']
344,31802506,Personalized Management of Chemotherapy-Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance).,"Chemotherapy-induced peripheral neuropathy (henceforth, neuropathy) is often dose limiting and is generally managed by empirical dose modifications. We aimed to (1) identify an early time point that is predictive of future neuropathy using a patient-reported outcome and (2) propose a dose-adjustment algorithm based on simulated data to manage neuropathy. In previous work, a dose-neuropathy model was developed using dosing and patient-reported outcome data from Cancer and Leukemia Group B 40502 (Alliance), a randomized phase III trial of paclitaxel, nanoparticle albumin-bound paclitaxel or ixabepilone as first-line chemotherapy for locally recurrent or metastatic breast cancer. In the current work, an early time point that is predictive of the future severity of neuropathy was identified based on predictive accuracy of the model. Using the early data and model parameters, simulations were conducted to propose a dose-adjustment algorithm for the prospective management of neuropathy in individual patients. The end of the first 3 cycles (12 weeks) was identified as the early time point based on a predictive accuracy of 75% for the neuropathy score after 6 cycles. For paclitaxel, nanoparticle albumin-bound paclitaxel, and ixabepilone, simulations with the proposed dose-adjustment algorithm resulted in 61%, 48%, and 35% fewer patients, respectively, with neuropathy score ≥8 after 6 cycles compared to no dose adjustment. We conclude that early patient-reported outcome data on neuropathy can be used to guide dose adjustments in individual patients that reduce the severity of future neuropathy. Prospective validation of this approach should be undertaken in future studies.",2020,"For paclitaxel, nanoparticle albumin-bound paclitaxel, and ixabepilone, simulations with the proposed dose-adjustment algorithm resulted in 61%, 48%, and 35% fewer patients, respectively, with neuropathy score ≥8 after 6 cycles compared to no dose adjustment.",['locally recurrent or metastatic breast cancer'],"['paclitaxel, nanoparticle albumin-bound paclitaxel or ixabepilone', 'paclitaxel, nanoparticle albumin-bound paclitaxel, and ixabepilone']",[],"[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}, {'cui': 'C1135132', 'cui_str': 'ixabepilone'}]",[],,0.021527,"For paclitaxel, nanoparticle albumin-bound paclitaxel, and ixabepilone, simulations with the proposed dose-adjustment algorithm resulted in 61%, 48%, and 35% fewer patients, respectively, with neuropathy score ≥8 after 6 cycles compared to no dose adjustment.","[{'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Sharma', 'Affiliation': 'The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Shailly', 'Initials': 'S', 'LastName': 'Mehrotra', 'Affiliation': 'Center for Translational Medicine, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Alliance Statistics and Data Center, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners CancerCare/Harvard Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Lyss', 'Affiliation': 'Heartland Cancer Research NCORP, St. Louis, Missouri, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Lad', 'Affiliation': 'John H. Stroger Jr Hospital of Cook County, Chicago, Illinois, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Velasco', 'Affiliation': 'Decatur Memorial Hospital/Cancer Care Specialists of Illinois/Heartland Cancer Research NCORP, Decatur, Illinois, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': 'Dana-Farber/Partners CancerCare/Harvard Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Jogarao V', 'Initials': 'JV', 'LastName': 'Gobburu', 'Affiliation': 'Center for Translational Medicine, University of Maryland, Baltimore, Maryland, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1559']
345,30835436,Characterization of the Human Skeletal Muscle Metabolome for Elucidating the Mechanisms of Bicarbonate Ingestion on Strenuous Interval Exercise.,"Bicarbonate has long been touted as a putative ergogenic aid that improves exercise performance and blood buffering capacity during strenuous exercise. However, the underlying mechanisms of action of bicarbonate intake on skeletal muscle metabolism have yet to be fully elucidated. Herein, we apply two orthogonal analytical platforms for nontargeted profiling of metabolites and targeted analysis of electrolytes from mass-limited muscle tissue biopsies (∼2 mg dried mass) when multisegment injection-capillary electrophoresis-mass spectrometry (MSI-CE-MS) and CE with indirect UV detection are used, respectively. Seven untrained men performed a standardized bout of high-intensity interval exercise trial following either bicarbonate (0.40 g/kg) or placebo ingestion in a double-blinded, placebo-controlled, crossover study design, where paired skeletal muscle tissue and plasma specimens were collected at three time intervals at rest, postexercise, and recovery. Optimization of a quantitative microextraction procedure was first developed for lyophilized tissue prior to characterization of the human muscle metabolome, which resulted in the identification and quantification of more than 80 polar/ionic metabolites reliably (CV < 30%) detected in a majority (>75%) of samples with quality control. Complementary univariate and multivariate statistical methods were used to identify biomarkers associated with strenuous exercise and/or bicarbonate treatment responses, whereas structural elucidation of biologically significant intramuscular metabolites was performed using high-resolution MS/MS. Importantly, bicarbonate ingestion prior to strenuous interval exercise was found to elicit a modest treatment effect ( p < 0.05) in comparison to placebo on metabolic pathways associated with ionic homeostasis (potassium), purine degradation (uric acid), and oxidative stress as regulated by glutathione metabolism (oxidized mixed glutathione disulfide) and histidine-containing dipeptides (anserine) within muscle tissue that was distinctive from dynamic metabolic changes measured in circulation. This work provides deeper biochemical insights into the effect of acute alkalosis in preserving contracting muscle function during high-intensity exercise, which is also applicable to the study of muscle-related pathologies relevant to human health and aging.",2019,Complementary univariate and multivariate statistical methods were used to identify biomarkers associated with strenuous exercise,['Seven untrained men'],"['placebo ingestion', 'placebo', 'strenuous exercise', 'bicarbonate', 'Bicarbonate']","['ionic homeostasis (potassium), purine degradation (uric acid), and oxidative stress']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}]","[{'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0220903', 'cui_str': 'purine'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",,0.187506,Complementary univariate and multivariate statistical methods were used to identify biomarkers associated with strenuous exercise,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Saoi', 'Affiliation': 'Department of Chemistry and Chemical Biology , McMaster University , Hamilton , Ontario , Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Percival', 'Affiliation': 'Department of Kinesiology , McMaster University , Hamilton , Ontario , Canada.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Nemr', 'Affiliation': 'Department of Chemistry and Chemical Biology , McMaster University , Hamilton , Ontario , Canada.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Department of Chemistry and Chemical Biology , McMaster University , Hamilton , Ontario , Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gibala', 'Affiliation': 'Department of Kinesiology , McMaster University , Hamilton , Ontario , Canada.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Britz-McKibbin', 'Affiliation': 'Department of Chemistry and Chemical Biology , McMaster University , Hamilton , Ontario , Canada.'}]",Analytical chemistry,['10.1021/acs.analchem.9b00149']
346,31619413,Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol.,"INTRODUCTION


A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer.
METHODS


We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events.
ETHICS AND DISSEMINATION


The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets.
TRIAL REGISTRATION NUMBER


NCT02603341.",2019,"The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease.","['patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes', 'patients with non-metastatic breast cancer', '1278 patients with non-metastatic breast cancer', 'patients with breast cancer']","['proton versus photon therapy', 'proton therapy', 'photon or proton therapy', 'Radiotherapy Comparative Effectiveness (RadComp', 'Radiation therapy']","['major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease', 'cardiac morbidity and mortality', 'cancer recurrence and extending survival', 'urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0086805', 'cui_str': 'Photons'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0265122', 'cui_str': 'Disorder of pericardium (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}]",1278.0,0.145815,"The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease.","[{'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bekelman', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA bekelman@upenn.edu.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pugh', 'Affiliation': 'American College of Radiology, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kaysee', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Berg', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Amy Berrington', 'Initials': 'AB', 'LastName': 'de Gonzalez', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Lior Z', 'Initials': 'LZ', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bosch', 'Affiliation': 'Department of Radiation Oncology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Chauhan', 'Affiliation': 'Mayo Clinic Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'L Christine', 'Initials': 'LC', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Freedman', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hahn', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Haffty', 'Affiliation': 'Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Atif J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Jimenez', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Kesslering', 'Affiliation': 'Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'Cardio-Oncology Program, Division of Cardiovascular Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Choonsik', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hsiao-Ming', 'Initials': 'HM', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Mishra', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Mullins', 'Affiliation': 'PHSR, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Mutter', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Nagda', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pankuch', 'Affiliation': 'Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, USA.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Powell', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Fred W', 'Initials': 'FW', 'LastName': 'Prior', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schupak', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Alphonse G', 'Initials': 'AG', 'LastName': 'Taghian', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'J Ben', 'Initials': 'JB', 'LastName': 'Wilkinson', 'Affiliation': 'Provision Proton Therapy Center, Knoxville, Tennessee, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'MacDonald', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Cahlon', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025556']
347,32220595,Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study.,"OBJECTIVE


The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone 0.1 mg/mL solution in Mucolox (arm A) compared with dexamethasone 0.1 mg/mL solution alone (arm B) for treatment of oral lichen planus (OLP).
STUDY DESIGN


Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater were randomized to arm A or B. Reticulation/erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at the baseline and the end of treatment (4 weeks). Differences were assessed by using Wilcoxon's rank-sum test.
RESULTS


Twenty-four patients (females n = 21; median age 64.5 years; range 45-80 years) were randomly assigned to arm A or B. Four patients were excluded. Dexamethasone with or without the addition of Mucolox was effective at reducing the REU score, but the Mucolox-containing solution was relatively more effective (6-point reduction vs 4.3-point reduction; P < .001). There was significant improvement in the total COMDQ score in both arms (mean change 1.8 [arm A] vs 2.5 [arm B]). There were no differences in compliance between the 2 study arms (P = .58).
CONCLUSIONS


Dexamethasone 0.1 mg/mL solution in Mucolox was more effective for the management of OLP compared with dexamethasone 0.1 mg/mL solution alone. Larger studies are needed to confirm these preliminary findings.",2020,There was significant improvement in the total COMDQ score in both arms (mean change 1.8,"['oral lichen planus', 'Twenty-four patients (females n\xa0=\xa021; median age 64.5 years; range 45-80 years', 'Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater']","['Dexamethasone solution and dexamethasone', 'dexamethasone 0.1 mg/mL solution alone', 'dexamethasone', 'Dexamethasone']","['erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ', 'REU score', 'safety and efficacy', 'total COMDQ score']","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023643', 'cui_str': 'Lichen condition'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2746127', 'cui_str': 'Dexamethasone 0.1 MG/ML [Baycadron]'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0151785', 'cui_str': 'Disorder of mucous membrane'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.193386,There was significant improvement in the total COMDQ score in both arms (mean change 1.8,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Villa', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA. Electronic address: Avilla@partners.org.""}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Sankar', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Bassani', 'Affiliation': 'Professional Compounding Centers of America, Houston, TX, USA.'}, {'ForeName': 'Lisa Bennett', 'Initials': 'LB', 'LastName': 'Johnson', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Sroussi', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.02.014']
348,30226112,A Comparative Effectiveness Trial of Depression Collaborative Care: Subanalysis of Comorbid Anxiety.,"The purpose of this exploratory subanalysis was to compare the effects of two depression quality improvement approaches on clinical outcomes and service utilization for individuals with comorbid depression/anxiety. This study used data from Community Partners in Care (CPIC), a cluster-randomized comparative effectiveness trial ( N  = 1,018; depression = 360; comorbid depression/anxiety = 658). Each intervention arm received the same quality improvement materials, plus either technical support (Resources for Services, RS) or support for collaborative implementation planning (Community Engagement and Planning, CEP). For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months. The effects were not significant at 12 months. A collaborative planning process versus technical support for depression quality improvement can have short-term effects on mental wellness and social determinants of health among those with comorbid depression/anxiety.",2019,"For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months.","['individuals with comorbid depression/anxiety', 'Community Partners in Care (CPIC), a cluster-randomized comparative effectiveness trial ( N  = 1,018; depression = 360; comorbid depression/anxiety = 658']","['same quality improvement materials, plus either technical support (Resources for Services, RS) or support for collaborative implementation planning (Community Engagement and Planning, CEP', 'depression quality improvement approaches']","['behavioral hospitalizations and homelessness risk', 'mental health-related quality of life and mental wellness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0486457,"For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months.","[{'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Choi', 'Affiliation': '1 Division of General Internal Medicine & Health Services Research, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sherbourne', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Lingqi', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': '3 David Geffen School of Medicine at UCLA, CA, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Castillo', 'Affiliation': '5 Los Angeles County Department of Mental Health, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dixon', 'Affiliation': '6 UCLA School of Nursing, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': '7 Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Eisen', 'Affiliation': '5 Los Angeles County Department of Mental Health, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}]",Western journal of nursing research,['10.1177/0193945918800333']
349,32199338,Split Skin Graft Take in Leg Ulcers: Conventional Dressing Versus Locally Adapted Negative Pressure Dressing.,"BACKGROUND


Split-thickness skin grafting is widely used in the management of leg ulcers but is fraught with suboptimal take especially in less than ideal wound beds. The use of negative pressure dressing to prepare wound beds is an established practice. However, its use to improve graft survival is yet to be a common practice. We aim to compare quantitative and qualitative split thickness skin graft take in leg and foot ulcers using either traditional wound dressing or negative pressure dressing methods.
METHODS


Sixty-two cases were recruited for the study and assigned into two groups of 31 cases each by convenient sampling method. Group A patients had negative pressure dressings in both phases, whereas group B patients had traditional wound dressing in both phases. The percentage skin graft take for both groups, and the pattern of complications were assessed. Results were analyzed using IBM SPSS statistics for windows (version 21.0; IBM Corp, Armonk, NY). Student t-test was used to compare the percentage graft take, whereas Chi-square was used to compare significance of complications in both dressing methods.
RESULTS


The negative pressure dressing showed better skin graft take with mean value of 99.2 ± 0.95% compared with traditional dressing with mean take of 89.7 ± 6.44%, which was statistically significant with a P value of <0.001. The complication rate was 12.9% in the negative pressure dressing group and 96.8% in the traditional wound dressing group, showing about 7.5 times more complication in the traditional wound dressing. This is statistically significant with a P value < 0.001.
CONCLUSIONS


Negative pressure dressing for split-thickness skin graft contributes significantly to improved split-thickness skin graft take with reduced complication rate as compared with conventional wound dressing method.",2020,"The complication rate was 12.9% in the negative pressure dressing group and 96.8% in the traditional wound dressing group, showing about 7.5 times more complication in the traditional wound dressing.","['Leg Ulcers', 'Sixty-two cases were recruited for the study and assigned into two groups of 31 cases each by convenient sampling method']","['Conventional Dressing Versus Locally Adapted Negative Pressure Dressing', 'negative pressure dressing', 'Split Skin Graft Take', 'traditional wound dressing or negative pressure dressing methods']","['IBM SPSS statistics', 'percentage skin graft take', 'negative pressure dressings', 'graft survival', 'complication rate', 'traditional wound dressing']","[{'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3831015', 'cui_str': 'Convenient (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1956079', 'cui_str': 'Negative-Pressure Dressings'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C1956079', 'cui_str': 'Negative-Pressure Dressings'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]",62.0,0.0349129,"The complication rate was 12.9% in the negative pressure dressing group and 96.8% in the traditional wound dressing group, showing about 7.5 times more complication in the traditional wound dressing.","[{'ForeName': 'Charles Chidiebele', 'Initials': 'CC', 'LastName': 'Maduba', 'Affiliation': 'Department of Surgery, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria. Electronic address: charlesmaduba@gmail.com.'}, {'ForeName': 'Ugochukwu Uzodimma', 'Initials': 'UU', 'LastName': 'Nnadozie', 'Affiliation': 'Department of Surgery, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria; Department of Surgery, Ebonyi State University, Abakaliki, Nigeria.'}, {'ForeName': 'Victor Ifeanyichukwu', 'Initials': 'VI', 'LastName': 'Modekwe', 'Affiliation': 'Division of Paediatric Surgery, Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'Ifeanyichukwu Igwilo', 'Initials': 'II', 'LastName': 'Onah', 'Affiliation': 'Department of Plastic Surgery, National Orthopaedic Hospital, Enugu, Nigeria.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.029']
350,30694699,Influence of Sex on the Changes in Regional Fat and Skeletal Muscle Mass in Response to Exercise Training in Adolescents with Obesity.,"BACKGROUND


We retrospectively examined the sex differences in the changes in (1) total fat, total and regional subcutaneous adipose tissue (SAT), visceral fat, and intermuscular fat and (2) total and regional skeletal muscle distribution in response to aerobic exercise (AE) or resistance exercise (RE) in adolescents with obesity.
METHODS


Twenty-eight boys and 27 girls with obesity (BMI ≥95th percentile, 12-18 years) were randomly assigned to 3-month interventions (180 minutes per week) of AE or RE. Changes in total and regional fat and skeletal muscle distribution were assessed by a whole-body magnetic resonance imaging.
RESULTS


After controlling for corresponding baseline values, age, and race, changes in body weight, BMI, BMI z-score, and waist circumference were similar between exercise groups (p > 0.05) and sexes (p > 0.05). There were no sex or exercise group differences in the reductions in total fat, total SAT, visceral fat, or intermuscular fat. With AE, boys had greater (p < 0.05) reductions in abdominal SAT as compared with girls. With RE, boys had greater (p < 0.05) increases in total, upper body, and abdominal skeletal muscle as compared with girls. Independent of exercise modality, the improvement in VO 2max  was greater (p < 0.05) in boys than in girls. Independent of sex, the increase in muscular strength index was higher (p < 0.05) in the RE vs. AE group.
CONCLUSION


With the exception of abdominal SAT, there were no sex or exercise treatment differences in the reductions in total and regional fat. In response to RE, the increases in total and regional skeletal muscle were significantly greater in boys than in girls.",2019,"There were no sex or exercise group differences in the reductions in total fat, total SAT, visceral fat, or intermuscular fat.","['Twenty-eight boys and 27 girls with obesity (BMI ≥95th percentile, 12-18 years', 'adolescents with obesity', 'Adolescents with Obesity']","['AE or RE', 'Exercise Training', 'aerobic exercise (AE) or resistance exercise (RE', 'abdominal SAT']","['VO 2max', 'total, upper body, and abdominal skeletal muscle', 'total and regional skeletal muscle', 'total and regional fat', 'total fat, total SAT, visceral fat, or intermuscular fat', 'total fat, total and regional subcutaneous adipose tissue (SAT), visceral fat, and intermuscular fat and (2) total and regional skeletal muscle distribution', 'body weight, BMI, BMI z-score, and waist circumference', 'total and regional fat and skeletal muscle distribution', 'muscular strength index', 'abdominal SAT', 'Regional Fat and Skeletal Muscle Mass']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",28.0,0.029049,"There were no sex or exercise group differences in the reductions in total fat, total SAT, visceral fat, or intermuscular fat.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Deldin', 'Affiliation': '1 Marcella Niehoff School of Nursing, Loyola University Chicago, Chicago, IL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kuk', 'Affiliation': '2 School of Kinesiology and Health Science, York University, Toronto, Canada.'}, {'ForeName': 'SoJung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': '3 Division of Sports Medicine, Graduate School of Physical Education, Kyung Hee University, Yongin, Korea.'}]",Childhood obesity (Print),['10.1089/chi.2018.0329']
351,30711459,Live birth rates with a freeze-only strategy versus fresh embryo transfer: secondary analysis of a randomized clinical trial.,"RESEARCH QUESTION


What are the roles of serum progesterone and endometrial thickness as biomarkers in the decision between a freeze-only and fresh embryo transfer in IVF for women without polycystic ovary syndrome (PCOS)?
DESIGN


This was a secondary analysis of a randomized controlled trial including 782 couples who were followed up until the end of the first completed cycle. Couples scheduled for their first or second IVF cycle with a FSH/gonadotrophin-releasing hormone antagonist protocol were randomized to a freeze-only (n = 391) or fresh embryo transfer (n = 391) strategy. The endpoint for this analysis was live birth rate (LBR) after the first embryo transfer.
RESULTS


There was no significant difference in LBR after the first cycle between a freeze-only and fresh transfer strategy. When serum progesterone levels at trigger were in the third quartile (Q3, 1.14-1.53 ng/ml), LBR was significantly higher in the freeze-only versus fresh transfer group (P = 0.01); when serum progesterone was ≥1.14 ng/ml, LBR was significantly better in the freeze-only group (37.4% versus 23.8% in the fresh transfer group; P = 0.004). LBRs in the freeze-only and fresh embryo transfer groups were similar across all quartiles of endometrial thickness, although a small advantage for freeze-only in women with a very thin endometrium could not be excluded.
CONCLUSIONS


Serum progesterone level on the day of trigger may have potential as a biomarker on which to base a prospective decision about whether to use a freeze-only or fresh embryo transfer strategy in women undergoing IVF.",2019,"What are the roles of serum progesterone and endometrial thickness as biomarkers in the decision between a freeze-only and fresh embryo transfer in IVF for women without polycystic ovary syndrome (PCOS)?
","['women undergoing IVF', 'women without polycystic ovary syndrome (PCOS', '782 couples who were followed up until the end of the first completed cycle', 'Couples scheduled for their first or second IVF cycle with a FSH/gonadotrophin-releasing hormone antagonist protocol']","['freeze-only (n\u202f=\u202f391) or fresh embryo transfer', 'freeze-only strategy versus fresh embryo transfer']","['LBRs', 'live birth rate (LBR', 'LBR', 'Live birth rates', 'serum progesterone levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo (substance)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}]",782.0,0.0929966,"What are the roles of serum progesterone and endometrial thickness as biomarkers in the decision between a freeze-only and fresh embryo transfer in IVF for women without polycystic ovary syndrome (PCOS)?
","[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam. Electronic address: drlan@yahoo.com.vn.'}, {'ForeName': 'Toan D', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuong M', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu N A', 'Initials': 'VNA', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'The Robinson Research Institute, School of Medicine, Adelaide, Australia; Fertility SA, Adelaide, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Australia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2018.12.012']
352,30716790,A Multicentered Randomized Study on Early versus Rescue Calsurf Administration for the Treatment of Respiratory Distress Syndrome in Preterm Infants.,"OBJECTIVE


Surfactant and noninvasive ventilation are two major strategies for the treatment of neonates with respiratory distress syndrome (RDS). However, the optimal time for surfactant administering is yet controversial. This study compared the early and rescue Calsurf administration in preterm infants with RDS.
STUDY DESIGN


Preterm infants born between 26 0/7  and 32 6/7  weeks of gestation and needed nasal continuous positive airway pressure (nCPAP) immediately after birth were randomly assigned to the early or rescue Calsurf treatment group. In the early treatment group, neonates were intubated, administered surfactant with bag-mask ventilation, and extubated to nCPAP (INSURE [intubation-surfactant-extubation]). In the rescue treatment group, InSurE was given until the clinical manifestation and chest X-ray displayed RDS. The primary outcome was to compare the reintubation rate within 72 hour age between the two groups.
RESULTS


Among 305 neonates randomized to the early ( n  = 154) and rescue ( n  = 151) groups, the reintubation rate within 72 hours of age in these two groups did not differ significantly ( p >  0.05). The incidence of oxygen dependence until 36 weeks' corrected age was similar in both groups.
CONCLUSION


No differences were observed between early and rescue Calsurf treatment groups with respect to the reintubation rate within 72 hours of age and the incidence of bronchopulmonary dysplasia.",2019,No differences were observed between early and rescue Calsurf treatment groups with respect to the reintubation rate within 72 hours of age and the incidence of bronchopulmonary dysplasia.,"['305 neonates', 'neonates with respiratory distress syndrome (RDS', 'Respiratory Distress Syndrome in Preterm Infants', 'Preterm infants born between 26 0/7  and 32 6/7  weeks of gestation and needed nasal continuous positive airway pressure (nCPAP) immediately after birth', 'preterm infants with RDS']","['Surfactant and noninvasive ventilation', 'surfactant with bag-mask ventilation, and extubated to nCPAP (INSURE [intubation-surfactant-extubation', 'Rescue Calsurf Administration']","['incidence of oxygen dependence', 'reintubation rate']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]",305.0,0.0830345,No differences were observed between early and rescue Calsurf treatment groups with respect to the reintubation rate within 72 hours of age and the incidence of bronchopulmonary dysplasia.,"[{'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Rong', 'Affiliation': 'Neonatal Intensive Care Unit, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Neonatal Intensive Care Unit, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': ""Neonatal Intensive Care Unit, Huangshi Maternity and Children's Healthy Hospital, Huangshi, Hubei, China.""}, {'ForeName': 'Huizhen', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Neonatal Intensive Care Unit, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.""}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Neonatal Intensive Care Unit, Jingzhou Central Hospital, Jingzhou, Hubei, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Hubei University for Nationalities, Wuhan, Hubei, China.'}, {'ForeName': 'Qihong', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': ""Neonatal Intensive Care Unit, The First Affiliated Hospital of Yangtze University, The First People's Hospital of Jingzhou, Jingzhou, Hubei, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Neonatal Intensive Care Unit, The First Clinical Medical School of the Three Gorges University Yichang Central People's Hospital, Yichang, Hubei, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Pan', 'Affiliation': 'Neonatal Intensive Care Unit, Xiangyang Central Hospital, Xiangyang, Hubei, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': ""Neonatal Intensive Care Unit, The First People's Hospital of Tianmen, Tianmen, Hubei, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiao', 'Affiliation': ""Neonatal Intensive Care Unit, Hubei University of Medicine, Xiangyang No. 1 People's Hospital, Xiangyang, Hubei, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Neonatal Intensive Care Unit, Huanggang Central Hospital, Huanggang, Hubei, China.'}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Neonatal Intensive Care Unit, Hubei Maternal and Child Health Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Jijian', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Neonatal Intensive Care Unit, Taihe Hospital, Shiyan, Hubei, China.'}]",American journal of perinatology,['10.1055/s-0039-1678530']
353,32222396,Prognostic Value of Creatinine Concentration and Glomerular Filtration Rate in Acute Kidney Injury Development in the Early Postoperative Period After Heart Transplantation.,"INTRODUCTION


Recipients of nonrenal organ transplants, including the heart, are at risk for developing acute kidney injury (AKI). This situation significantly jeopardized the outcome of patients. The most effective treatment is continuous renal replacement therapy (CRRT) AIM: The goal of this project is to verify the prognostic value of preoperative serum creatinine concentration and glomerular filtration rate (GFR), calculated by the Modification of Diet in Renal Disease formula, to determine the risk of renal failure after grafting RESULTS: In the group of 39 patients, CRRT was needed in 7 patients (17.9%; group K); 32 patients were in the control group (group C). The pretransplant creatinine level in group K was 133.7 ± 31.3 μmol/L and in group C was 160.8 ± 97.6 μmol/L; P = .47. We did not find a difference between groups in GFR: group K 51 ± 6mL/min/1.73 m 2  versus group C 43 ± 20 mL/min/1.73 m 2 ; P = .65. Demographic data differed between groups. Patients in group C had significantly more often hypertension, diabetes mellitus, ischemic cardiomyopathy, and previous neurologic disorders and were male. Patients with CRRT had longer intensive care unit (ICU) stays after transplantation than the control population: 25 ± 19 versus 12 ± 10 days; P = .02. Other results showed that primary graft dysfunction occurred in 2 patients in group K and 6 in the control group; 1 needed extracorporeal membrane oxygenation support, and he died on the 12th day. The mean duration of renal replacement therapy was 9.8 days. There were 2 neurologic disorders-1 in each group-and 6 reoperations due to bleeding.
CONCLUSIONS


Developing AKI requiring CRRT after heart transplantation prolonged the length of ICU stays. Preoperative creatinine concentration and glomerular filtration rate do not predict AKI.",2020,We did not find a difference between groups in GFR: group K 51 ± 6mL,['Acute Kidney Injury Development in the Early Postoperative Period After Heart Transplantation'],[],"['primary graft dysfunction', 'Preoperative creatinine concentration and glomerular filtration rate', 'preoperative serum creatinine concentration and glomerular filtration rate (GFR', 'hypertension, diabetes mellitus, ischemic cardiomyopathy, and previous neurologic disorders', 'length of ICU stays', 'mean duration of renal replacement therapy', 'pretransplant creatinine level', 'CRRT', 'longer intensive care unit (ICU) stays']","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}]",[],"[{'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}]",32.0,0.0552853,We did not find a difference between groups in GFR: group K 51 ± 6mL,"[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Nadziakiewicz', 'Affiliation': 'Department of Cardiac Anesthesia and Intensive Therapy, Silesian Centre for Heart Diseases, Medical University of Silesia, Zabrze, Poland. Electronic address: pawelnadziakiewicz@gmail.com.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Grochla', 'Affiliation': 'Department of Cardiac Anesthesia and Intensive Therapy, Silesian Centre for Heart Diseases, Medical University of Silesia, Zabrze, Poland.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Krauchuk', 'Affiliation': 'Department of Anaesthesiology, Szpital Specjalistyczny, Zabrze, Poland.'}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Szyguła-Jurkiewicz', 'Affiliation': '3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Cymerys', 'Affiliation': ""Students' Scientific Society, Department of Cardiac Anesthesia and Intensive Therapy, Silesian Centre for Heart Diseases, Medical University of Silesia, Zabrze, Poland.""}, {'ForeName': 'Michał O', 'Initials': 'MO', 'LastName': 'Zembala', 'Affiliation': 'Department of Cardiac, Vascular, and Endovascular Surgery and Transplantology, Medical University of Silesia in Katowice, School of Medicine with the Division of Dentistry in Zabrze, Silesian Centre for Heart Diseases, Zabrze, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Przybyłowski', 'Affiliation': 'Department of Cardiac, Vascular, and Endovascular Surgery and Transplantology, Silesian Centre for Heart Diseases, Medical University of Silesia, Zabrze, Poland; General Surgery Department, Jagiellonian University, Medical College, Krakow, Poland.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.02.102']
354,32222767,Effectiveness of Mindfulness-Based Relapse Prevention Program as an Adjunct to the Standard Treatment for Smoking: A Pragmatic Design Pilot Study.,"INTRODUCTION


Posttreatment relapse is a major roadblock to stemming the global epidemic of tobacco-related illness. This article presents results from a pilot trial evaluating the feasibility and initial efficacy of Mindfulness-Based Relapse Prevention (MBRP) as an adjunct to standard relapse prevention treatment (ST) for smoking cessation.
AIMS AND METHODS


Smokers (n = 86) in the maintenance phase of treatment were randomized to receive either ST plus MBRP (MBRP) (n = 44) or ST alone (ST) (n = 42). Data were collected at baseline and at 4-, 12-, and 24-week follow-up points. We evaluated the feasibility of the protocol with frequency analysis, and the efficacy with both intention to treat and complete case analyses of the effects of MBRP on abstinence. Secondary outcomes included mindfulness, craving, depression, anxiety, and positive/negative affect.
RESULTS


High adherence suggested MBRP is acceptable and feasible. Participants in the MBRP group reported increases in mindfulness (M = -7.833, p = .016), and reductions in craving (M = 17.583, p = .01) compared with the ST group. Intention to treat analysis found that, compared with MBRP (36.4%), ST (57.1%) showed trend-level superiority in abstinence at Week 4 (Prevalence Ratio = 0.63, p = .06); however at Week 24, the ST group (14.3%) demonstrated a twofold greater decrease in abstinence, compared with the MBRP group (20.1%) (Prevalence Ratio = 2.25, p = .08). Therefore, the MBRP group maintained a higher abstinence rate for longer. Reported effects were greater in the complete case analysis.
CONCLUSIONS


MBRP holds promise for preventing relapse after aided tobacco quit attempts.
IMPLICATIONS


Findings suggest that MBRP is acceptable, feasible, and valued by participants. At 24-week follow-up, there was a large effect size and a statistical trend toward fewer MBRP patients relapsing compared with ST patients. MBRP conferred ancillary benefits including reductions in craving and increases in levels of mindfulness. MBRP for tobacco cessation is highly promising and merits further research.
TRIAL REGISTRATION


clinicaltrials.gov.
IDENTIFIER


NCT02327104.",2020,"Participants in the MBRP group reported increases in mindfulness (M = -7.833, p = 0.016), and reductions in craving (M = 17.583, p = 0.01) compared to the ST group.","['Smoking', 'Smokers (n = 86) in the maintenance phase of treatment']","['ST alone (ST', 'Mindfulness-Based Relapse Prevention (MBRP', 'Mindfulness-based Relapse Prevention Program', 'MBRP', 'ST plus MBRP (MBRP']","['reductions in craving', 'abstinence', 'levels of mindfulness', 'mindfulness, craving, depression, anxiety and positive/negative affect', 'abstinence rate']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",86.0,0.0270665,"Participants in the MBRP group reported increases in mindfulness (M = -7.833, p = 0.016), and reductions in craving (M = 17.583, p = 0.01) compared to the ST group.","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Weiss de Souza', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elisa Harumi', 'Initials': 'EH', 'LastName': 'Kozasa', 'Affiliation': 'Instituto do Cérebro, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'University of Kansas School of Medicine, Department of Preventive Medicine and Public Health, Kansas City, KS.'}, {'ForeName': 'Laisa Marcorela Andreoli', 'Initials': 'LMA', 'LastName': 'Sartes', 'Affiliation': 'Departamento de Psicologia, Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Fernando Antônio Basile', 'Initials': 'FAB', 'LastName': 'Colugnati', 'Affiliation': 'Department of Internship/Medicine School, Universidade Federal de Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Ana Regina', 'Initials': 'AR', 'LastName': 'Noto', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa057']
355,32087146,Evaluation of an external fetal electrocardiogram monitoring system: a randomized controlled trial.,"OBJECTIVE


The objective of the study was to compare interpretability of 2 intrapartum abdominal fetal heart rate-monitoring strategies. We hypothesized that an external fetal electrocardiography monitoring system, a newer technology using wireless abdominal pads, would generate more interpretable fetal heart rate data compared with standard external Doppler fetal heart rate monitoring (standard external monitoring).
STUDY DESIGN


We conducted a randomized controlled trial at 4 Utah hospitals. Patients were enrolled at labor admission and randomized in blocks based on body mass index to fetal electrocardiography or standard external monitoring. Two reviewers, blinded to study allocation, reviewed each fetal heart rate tracing. The primary outcome was the percentage of interpretable minutes of fetal heart rate tracing. An interpretable minute was defined as >25% fetal heart rate data present and no more than 25% continuous missing fetal heart rate data or artifact present. Secondary outcomes included the percentage of interpretable minutes of fetal heart rate tracing obtained while on study device only, the number of device adjustments required intrapartum, clinical outcomes, and patient/provider device satisfaction. We determined that 100 patients per arm (200 total) would be needed to detect a 5% difference in interpretability with 95% power.
RESULTS


A total of 218 women were randomized, 108 to fetal electrocardiography and 110 to standard external monitoring. Device setup failure occurred more often in the fetal electrocardiography group (7.5% [8 of 107] vs 0% [0 of 109] for standard external monitoring). There were no differences in the percentage of interpretable tracing between the 2 groups. However, fetal electrocardiography produced more interpretable fetal heart rate tracing in subjects with a body mass index ≥30 kg/m 2 . When considering the percentage of interpretable minutes of fetal heart rate tracing while on study device only, fetal electrocardiography outperformed standard external monitoring for all subjects, regardless of maternal body mass index. Maternal demographics and clinical outcomes were similar between arms. In the fetal electrocardiography group, more device changes occurred compared with standard external monitoring (51% vs 39%), but there were fewer nursing device adjustments (2.9 vs 6.2 mean adjustments intrapartum, P < .01). There were no differences in physician device satisfaction scores between groups, but fetal electrocardiography generated higher patient satisfaction scores.
CONCLUSION


Fetal electrocardiography performed similarly to standard external monitoring when considering percentage of interpretable tracing generated in labor. Furthermore, patients reported overall greater satisfaction with fetal electrocardiography in labor. Fetal electrocardiography may be particularly useful in patients with a body mass index ≥30 kg/m 2 .",2020,Device set up failure occurred more often in the fetal electrocardiography group (7.5% (8/107) versus 0% (0/109) for standard external monitoring).,"['subjects with body mass index ≥30', '100 patients per arm (200 total', 'patients with body mass index ≥30', 'Patients were enrolled at labor admission and randomized in', '218 women were randomized, 108 to fetal electrocardiography and 110 to standard external monitoring', 'four Utah hospitals']","['fetal electrocardiography', 'blocks based on body mass index to fetal electrocardiography or standard external monitoring', 'external fetal electrocardiogram monitoring system', 'Fetal electrocardiography']","['percentage of interpretable minutes of fetal heart rate tracing', 'device changes', 'percentage of interpretable minutes of fetal heart rate tracing obtained while on study device only, the number of device adjustments required intrapartum, clinical outcomes, and patient/provider device satisfaction', 'Maternal demographics and clinical outcomes', 'fetal heart rate tracing', 'physician device satisfaction scores']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0278336', 'cui_str': 'Fetal electrocardiogram (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442822', 'cui_str': 'Trace (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",218.0,0.107003,Device set up failure occurred more often in the fetal electrocardiography group (7.5% (8/107) versus 0% (0/109) for standard external monitoring).,"[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Monson', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT; University of Utah Health, Salt Lake City, UT. Electronic address: martha.monson@hsc.utah.edu.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Heuser', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT; University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Einerson', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT; University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Esplin', 'Affiliation': 'Brigham Young University, Salt Lake City, UT.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Snow', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT; University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'M Sean', 'Initials': 'MS', 'LastName': 'Esplin', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT; University of Utah Health, Salt Lake City, UT.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.012']
356,32217951,Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],"['Mifepristone Antagonization', 'Progesterone']",[],"[{'cui': 'C3146283', 'cui_str': 'Medical abortion'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.194373,,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Delgado', 'Affiliation': 'Steno Institute, Escondido, California Steno Institute, El Sobrante, California Steno Institute, Mount Pleasant, North Carolina.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Davenport', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003780']
357,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
358,32227244,Isradipine Versus Placebo in Early Parkinson Disease.,,2020,,['Early Parkinson Disease'],['Isradipine Versus Placebo'],[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0516642,,[],Annals of internal medicine,['10.7326/P20-0004']
359,32227247,Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial.,"Background


Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinson disease (PD).
Objective


To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD.
Design


Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842).
Setting


57 Parkinson Study Group sites in North America.
Participants


Patients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment.
Intervention


5 mg of immediate-release isradipine twice daily or placebo for 36 months.
Measurements


The primary outcome was change in the Unified Parkinson's Disease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication ""ON"" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures.
Results


336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study. Adjusted least-squares mean changes in total UPDRS score in the antiparkinson medication ON state over 36 months for isradipine and placebo recipients were 2.99 (95% CI, 0.95 to 5.03) points versus 3.26 (CI, 1.25 to 5.26) points, respectively, with a treatment effect of -0.27 (CI, -3.02 to 2.48) point (P = 0.85). Statistical adjustment for antiparkinson medication use did not change the findings. Secondary outcomes showed no effect of isradipine treatment. The most common adverse effects of isradipine were edema and dizziness.
Limitation


The isradipine dose may have been insufficient to engage the target calcium channels associated with neuroprotective effects.
Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
Primary Funding Source


National Institute of Neurological Disorders and Stroke.",2020,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","['336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study', 'Participants\n\n\nPatients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment', 'Setting\n\n\n57 Parkinson Study Group sites in North America', 'Early Parkinson Disease']","['dihydropyridine calcium-channel blocker', 'placebo', 'dihydropyridine calcium-channel blockers', 'isradipine', 'Intervention\n\n\n5 mg of immediate-release isradipine twice daily or placebo', 'Isradipine Versus Placebo']","[""Unified Parkinson's Disease Rating Scale (UPDRS) parts"", 'time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures', 'total UPDRS score', 'edema and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",336.0,0.515182,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2534']
360,30773798,"Klotho, fibroblast growth factor-23, and the renin-angiotensin system - an analysis from the PEACE trial.","AIMS


Klotho, an essential co-receptor for fibroblast growth factor (FGF)-23, has potentially beneficial inhibitory effects on the renin-angiotensin system. Limited data exist on the prognostic value of Klotho and FGF-23 levels in combination or their ability to predict benefit from angiotensin-converting enzyme (ACE) inhibition.
METHODS AND RESULTS


A total of 3555 patients with stable ischaemic heart disease and left ventricular ejection fraction > 40% enrolled in the PEACE trial of trandolapril vs. placebo had Klotho levels drawn at randomization. Patients were characterized by quartiles of Klotho and FGF-23 concentrations. Six-year Kaplan-Meier rates and adjusted risk were calculated in the placebo arm for the composite of cardiovascular (CV) death or hospitalization for heart failure and its components. Low [quartile (Q) 1-3] Klotho concentration was associated with an increased rate of CV death or hospitalization for heart failure as compared with Q4 (8.2% vs. 4.2%; P = 0.03). After multivariable adjustment for clinical variables and renal and CV biomarkers (estimated glomerular filtration rate, cystatin-C, urine albumin-to-creatinine ratio, FGF-23, high-sensitivity troponin T, N-terminal pro-B-type natriuretic peptide, and high-sensitivity C-reactive protein), low Klotho concentration remained strongly associated with increased risk of CV death or hospitalization for heart failure [adjusted hazard ratio (HR) 2.62; 95% confidence interval (CI) 1.35-5.08; P < 0.01]. The combination of low Klotho and high (Q4) FGF-23 concentration identified patients at particularly elevated risk (adjusted HR 3.99; 95% CI 1.67-9.56; P < 0.01). This high-risk combination additionally predicted benefit from trandolapril (HR 0.39; 95% CI 0.23-0.68; P interaction   < 0.01).
CONCLUSIONS


Low Klotho concentration is associated with an increased risk of CV death or heart failure hospitalization in patients with stable ischaemic heart disease. The combination of low Klotho and high FGF-23 further identifies patients at distinctly elevated risk who derive clinical benefit from the ACE-inhibitor trandolapril.",2019,Klotho concentration was associated with an increased rate of CV death or hospitalization for heart failure as compared with Q4 (8.2% vs. 4.2%; P = 0.03).,"['had Klotho levels drawn at randomization', 'patients with stable ischaemic heart disease', '3555 patients with stable ischaemic heart disease and left ventricular ejection fraction >\u200940% enrolled in the PEACE trial of']","['trandolapril', 'trandolapril vs. placebo', 'placebo', 'ACE-inhibitor trandolapril']","['rate of CV death or hospitalization for heart failure', 'Klotho concentration', 'risk of CV death or heart failure hospitalization', 'clinical variables and renal and CV biomarkers (estimated glomerular filtration rate, cystatin-C, urine albumin-to-creatinine ratio, FGF-23, high-sensitivity troponin T, N-terminal pro-B-type natriuretic peptide, and high-sensitivity C-reactive protein), low Klotho concentration', 'risk of CV death or hospitalization for heart failure']","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0076891', 'cui_str': 'trandolapril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",3555.0,0.156287,Klotho concentration was associated with an increased rate of CV death or hospitalization for heart failure as compared with Q4 (8.2% vs. 4.2%; P = 0.03).,"[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""Department of Medicine, Women's College Hospital and the University Health Network, Toronto, Canada.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Medicine and Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1424']
361,32217952,Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],"['Mifepristone Antagonization', 'Progesterone']",[],"[{'cui': 'C3146283', 'cui_str': 'Medical abortion'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.194373,,"[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Butterfield-Kalk', 'Affiliation': 'San Antonio, Texas.'}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003786']
362,32114213,Learning Intracorporeal Suture on Pelvitrainer Using a Robotized Versus Conventional Needle Holder.,"BACKGROUND


Laparoscopy is the gold standard approach in numerous surgical procedures. A new generation of robotized instruments has been developed to compensate for the ergonomic constraints of conventional instruments. The main objective was to compare the learning curves of novices for intracorporeal suturing on a laparoscopy pelvitrainer, using either a robotized needle holder or conventional needle holders. The post-training performances under ergonomically difficult conditions were also analyzed.
MATERIALS AND METHODS


Fifth-year medical students were randomized in group A using a robotized needle holder (JAIMY; Endocontrol, Grenoble, France) and group B using straight conventional needle holders. They undertook four training sessions (intracorporeal knot-tying task) followed by an evaluation session (intracorporeal knots-tying task, frontal suture, and hexagonal suture).
RESULTS


Twenty participants were included. The performances of the two groups (n = 10) were not significantly different at baseline. During the training sessions, there was a learning curve with a plateau at the third session for both the groups. At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762). There was a significant difference between group A and group B for the frontal suture (median global score: 15.75 versus 3.75 respectively; P = 0.005) but not for the hexagonal suture (median global score: 18 versus 15 respectively; P = 0.284).
CONCLUSIONS


Learning curves were equally fast using the robotized needle holder versus conventional instruments and led to equivalent performances. Under ergonomically difficult conditions, the robotized needle holder provided an advantage relative to conventional instruments.",2020,"At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762).","['Fifth-year medical students', 'Twenty participants were included']","['robotized needle holder or conventional needle holders', 'training sessions (intracorporeal knot-tying task) followed by an evaluation session (intracorporeal knots-tying task, frontal suture, and hexagonal suture', 'Learning Intracorporeal Suture on Pelvitrainer', 'robotized needle holder (JAIMY; Endocontrol, Grenoble, France) and group B using straight conventional needle holders', 'Robotized Versus Conventional Needle Holder']",['intracorporeal knot-tying task'],"[{'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0181952', 'cui_str': 'Needle holder, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}]","[{'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}]",20.0,0.0237045,"At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Siri', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Crochet', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France. Electronic address: pcrochet.marseille@gmail.com.'}, {'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Charavil', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Netter', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Resseguier', 'Affiliation': 'Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Aubert', 'Initials': 'A', 'LastName': 'Agostini', 'Affiliation': 'Department of Obstetrics and Gynecology, Assistance Publique - Hôpitaux de Marseille, La Conception Hospital, Aix Marseille Université, Marseille, France.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.016']
363,32015783,Clinical Rehabilitation Effect of Postoperative Lower-Limb Training on the Patients Undergoing OLIF Surgery: A Retrospective Study.,"Background


In this study, it was aimed to investigate the clinical rehabilitation effect of lower-limb training on the patients that undergo oblique lumbar interbody fusion (OLIF) procedures.
Methods


The eligible participants undergoing OLIF procedures between 01/2017 and 07/2019 were identified. All the patients underwent one-segment fusion operation (L3-4 or L4-5). Based on whether the participants received postoperative rehabilitation training, they were divided into two groups: intervention group and control group. Postoperatively, the participants in the intervention group were trained with lower-extremity rehabilitation exercise and maintained for three months. All participants got reexamined at the first postoperative week, the second postoperative week, the first postoperative month, and the third postoperative month (last follow-up). Comparisons were made in terms of the lower-extremity muscle force, visual analogue scale (VAS) score, lumbar JOA score, Oswestry disability index (ODI), the incidence of deep venous thrombosis (DVT), and patient satisfaction.
Results


Seventy-seven participants in the intervention group (32 males and 45 females) and 82 in the control group (39 males and 43 females) were incorporated in this study. The median age of the participants was 57 years (39∼73) in the intervention group and 54 years (35∼71) in the control group. No statistical significance between the two groups was found ( P  > 0.05). ODI score was less in the intervention group as compared to the control group in the first week after surgery ( P =0.029). VAS and JOA scores were better in the intervention group in the first two weeks after surgery ( P  < 0.05). DVT incidence in the intervention group was lower than the control group at final follow-up ( P =0.037). Both group participants have achieved good grading in muscle force rehabilitation but no significant differences between the two groups. Additionally, satisfaction was higher in the intervention group than the control group.
Conclusions


In summary, postoperative lower-extremity rehabilitation exercise can effectively accelerate patients' health recovery from the OLIF surgery and increase their satisfaction.",2020,DVT incidence in the intervention group was lower than the control group at final follow-up ( P =0.037).,"['The median age of the participants was 57 years (39∼73) in the intervention group and 54 years (35∼71) in the control group', 'Results\n\n\nSeventy-seven participants in the intervention group (32 males and 45 females) and 82 in the control group (39 males and 43 females', 'patients that undergo oblique lumbar interbody fusion (OLIF) procedures', 'eligible participants undergoing OLIF procedures between 01/2017 and 07/2019 were identified', 'Patients Undergoing OLIF Surgery']","['lower-limb training', 'Postoperative Lower-Limb Training', 'trained with lower-extremity rehabilitation exercise', 'postoperative rehabilitation training', 'intervention group and control group']","['satisfaction', 'good grading in muscle force rehabilitation', 'DVT incidence', 'VAS and JOA scores', 'ODI score', 'lower-extremity muscle force, visual analogue scale (VAS) score, lumbar JOA score, Oswestry disability index (ODI), the incidence of deep venous thrombosis (DVT), and patient satisfaction']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0556502', 'cui_str': 'Lower limb training (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.0173141,DVT incidence in the intervention group was lower than the control group at final follow-up ( P =0.037).,"[{'ForeName': 'Haoming', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Yachong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Spine Surgery, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Yachao', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Spine Surgery, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Botong', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Spine Surgery, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Dalong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Spine Surgery, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Sidong', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Spine Surgery, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Wenyuan', 'Initials': 'W', 'LastName': 'Ding', 'Affiliation': 'Department of Spine Surgery, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang 050051, Hebei Province, China.'}]",Pain research & management,['10.1155/2020/1065202']
364,32215135,Efficacy Analysis of Percutaneous Endoscopic Lumbar Discectomy Combined with PEEK Rods for Giant Lumbar Disc Herniation: A Randomized Controlled Study.,"Objective


This study describes a randomized controlled trial that assesses percutaneous endoscopic lumbar discectomy (PELD) combined with a polyetheretherketone (PEEK) rod in patients with GLDH (herniation affecting 50% of the sagittal diameter of the spinal canal) and reports the 2-year follow-up outcome.
Methods


In all, 243 patients were randomly assigned to undergo PELD or PELD combined with a PEEK rod by generating random numbers with a random number generator. Clinical outcome data, including the numerical rating scale (NRS), were used to assess the patients' back and leg pain, while the Oswestry Disability Index (ODI) was used to quantify pain and disability. Imaging data included intervertebral disc height (IDH), range of motion (ROM), and modified Pfirrmann grades.
Results


At the final follow-up, the NRS for back and leg pain and the ODI scores were significantly decreased in both groups. The NRS for back pain and the ODI scores in the PELD + PEEK group (1.32 ± 0.70, 14.10 ± 4.74) were better than those in the PELD group (1.91 ± 0.69, 16.93 ± 4.33) ( P  < 0.05). The IDH of the PELD + PEEK group (10.54 ± 1.62) was significantly higher than that in the PELD group (9.98 ± 1.90) ( P  < 0.05). The IDH of the PELD + PEEK group (10.54 ± 1.62) was significantly higher than that in the PELD group (9.98 ± 1.90) ( P  < 0.05). The IDH of the PELD + PEEK group (10.54 ± 1.62) was significantly higher than that in the PELD group (9.98 ± 1.90) (.
Conclusion


For symptomatic patients with GLDH, both PELD and PELD combined with a PEEK rod showed good efficacy. However, the long-term effect of PELD combined with a PEEK rod is better than that of PELD alone. Moreover, PELD combined with a PEEK rod can effectively reduce the recurrence rate. Maximum benefit can be gained if we adhere to strict selection criteria for PELD combined with a PEEK rod.",2020,"At the final follow-up, the NRS for back and leg pain and the ODI scores were significantly decreased in both groups.","['patients with GLDH (herniation affecting 50% of the sagittal diameter of the spinal canal', '243 patients', 'Giant Lumbar Disc Herniation']","['PELD', 'PELD or PELD combined with a PEEK rod by generating random numbers with a random number generator', 'percutaneous endoscopic lumbar discectomy (PELD) combined with a polyetheretherketone (PEEK', 'Percutaneous Endoscopic Lumbar Discectomy Combined with PEEK Rods']","['NRS for back pain and the ODI scores', ""patients' back and leg pain, while the Oswestry Disability Index (ODI"", 'intervertebral disc height (IDH), range of motion (ROM), and modified Pfirrmann grades', 'NRS for back and leg pain and the ODI scores', 'recurrence rate', 'pain and disability', 'numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0037922', 'cui_str': 'Spinal Canal'}, {'cui': 'C0017547', 'cui_str': 'Pituitary Gigantism'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0206427', 'cui_str': 'Retinal Rod'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0021815', 'cui_str': 'Intervertebral Disc'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}]",243.0,0.0418767,"At the final follow-up, the NRS for back and leg pain and the ODI scores were significantly decreased in both groups.","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Kaiying', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Keran', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Zhengjian', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Chongqing Medical University, No. 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}]",Pain research & management,['10.1155/2020/3401605']
365,31950895,Effects of dynamic neuromuscular stabilization (DNS) training on functional movements.,"Functional movements (FMs) dysfunction is a potential risk factor of injuries. A variety of training strategies is proposed to improve the performance of FMs. We investigated if a system of fundamental movement exercises called Dynamic Neuromuscular Stabilization (DNS) could improve FMs. Thirty-four female students were randomly assigned into two matched groups to receive DNS (the study protocol) versus physical fitness (PF) training. The groups practiced for six-weeks (three sessions of 50 min weekly). We used five FMs tests as pre and post measures of exercise effectiveness. Repeated Measures ANOVA showed a significant interaction in all five FMs tests in favour of DNS group (F (1,32)  ≥ 4.13, P ≤ .001 and ƞ 2  ≥ 0.29), meaning that DNS group had a higher progress rate compared to that of PF group. Based on Eta-square coefficients, the highest and lowest differences in the progression rate were observed in Y-Balance and Functional Movement Screening Tests, respectively. Our findings supported the hypothesis that fundamental movements of DNS could be used to improve FMs. However, the progression coefficient declined as FMs became more specific. Lower progression of ""specific FMs"" suggests that it might prove more effective to add ""specific training"" to ""fundamental training"" for them.",2020,"Repeated Measures ANOVA showed a significant interaction in all five FMs tests in favour of DNS group (F (1,32)  ≥ 4.13, P ≤ .001 and ƞ 2  ≥ 0.29), meaning that DNS group had a higher progress rate compared to that of PF group.",['Thirty-four female students'],"['DNS', 'fundamental movement exercises called Dynamic Neuromuscular Stabilization (DNS', 'dynamic neuromuscular stabilization (DNS) training', 'physical fitness (PF) training']","['Functional movements (FMs) dysfunction', 'progression rate', 'functional movements']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1535955', 'cui_str': 'Physical fitness training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",34.0,0.0147654,"Repeated Measures ANOVA showed a significant interaction in all five FMs tests in favour of DNS group (F (1,32)  ≥ 4.13, P ≤ .001 and ƞ 2  ≥ 0.29), meaning that DNS group had a higher progress rate compared to that of PF group.","[{'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Mahdieh', 'Affiliation': 'Department of Sport Injuries and Corrective Exercises, Faculty of Exercise Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Zolaktaf', 'Affiliation': 'School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: v.zolaktaf@spr.ui.ac.ir.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Karimi', 'Affiliation': 'School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Human movement science,['10.1016/j.humov.2019.102568']
366,32221587,"Comparison of interleukin-6, C-reactive protein, and low-density lipoprotein cholesterol as biomarkers of residual risk in contemporary practice: secondary analyses from the Cardiovascular Inflammation Reduction Trial.","AIMS


In epidemiologic cohorts initiated >30 years ago, inflammatory biomarkers, such as interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP) were shown to independently predict future cardiovascular events with a magnitude of effect comparable to that of low-density lipoprotein cholesterol (LDLC). Whether aggressive contemporary therapy for atherosclerosis has altered these relationships is unknown yet has major implications for future drug development.
METHODS AND RESULTS


Interleukin-6, hsCRP, and LDLC were measured at baseline in up to 4168 North American patients enrolled in the contemporary Cardiovascular Inflammation Reduction Trial with prior myocardial infarction or multivessel coronary disease who additionally had diabetes or metabolic syndrome and were followed for a period of up to 5 years for incident major recurrent cardiovascular events and all-cause mortality. Three-quarters of the cohort were previously revascularized and the great majority was taking statins, angiotensin blocking agents, beta-blockers, and antithrombotic agents. Participants were randomly allocated to low-dose methotrexate 15 mg weekly or to placebo. Randomized use of methotrexate had no effect on event rates nor plasma levels of IL-6, hsCRP, or LDL over time. Yet, baseline levels of IL-6, hsCRP, and LDLC were all predictors of major recurrent cardiovascular events; adjusted hazard ratios [HR; 95% confidence interval (CI)] for the lowest to highest baseline quartiles of IL-6 were 1.0 (referent), 1.66 (1.18-2.35), 1.92 (1.36-2.70), and 2.11 (1.49-2.99; P < 0.0001), while adjusted HRs for increasing quartiles of hsCRP were 1.0 (referent), 1.28 (0.92-1.79), 1.73 (1.25-2.38), and 1.79 (1.28-2.50; P < 0.0001) and adjusted HRs for increasing quartiles of LDLC were 1.0 (referent), 1.12 (0.78-1.62), 1.25 (0.87-1.79), and 2.38 (1.72-3.30; P < 0.0001). Effect estimates were not statistically different in these analyses for comparisons between IL-6, hsCRP, or LDLC, although IL-6 was the strongest predictor of all-cause mortality. The highest absolute risks were observed among those with elevated levels of both cholesterol and inflammation [HR 6.4 (95% CI 2.9-14.1) for those in the top quartiles of baseline IL-6 and LDLC, HR 4.9 (95% CI 2.6-9.4) for those in the top quartiles of baseline hsCRP and LDLC, both P < 0.0001].
CONCLUSION


Despite aggressive contemporary secondary prevention efforts, the relationships between inflammation, cholesterol, and cardiovascular risk are largely unchanged from those described two decades ago. These data are consistent with the hypothesis that future treatments for atherosclerosis may require a combination of inflammation inhibition and additional cholesterol reduction.
CLINICAL TRIAL


ClinicalTrials.gov NCT01594333.",2020,"Randomized use of methotrexate had no effect on event rates nor plasma levels of IL-6, hsCRP, or LDL over time.",['4168 North American patients enrolled in the contemporary Cardiovascular Inflammation Reduction Trial with prior myocardial infarction or multivessel coronary disease who additionally had diabetes or metabolic syndrome and were followed for a period of up to 5\u2009years for incident major recurrent cardiovascular events and all-cause mortality'],"['methotrexate 15\u2009mg weekly or to placebo', 'methotrexate', 'interleukin-6, C-reactive protein, and low-density lipoprotein cholesterol']","['cholesterol and inflammation', 'baseline levels of IL-6, hsCRP, and LDLC', 'event rates nor plasma levels of IL-6, hsCRP, or LDL over time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C1127565', 'cui_str': 'Methotrexate 15 MG'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.315218,"Randomized use of methotrexate had no effect on event rates nor plasma levels of IL-6, hsCRP, or LDL over time.","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Division of Preventive Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Brigham and Women's Hospital, Boston, MA 02215, USA.""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Division of Preventive Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Brigham and Women's Hospital, Boston, MA 02215, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Preventive Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Brigham and Women's Hospital, Boston, MA 02215, USA.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Bradwin', 'Affiliation': ""Department of Laboratory Medicine, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Hasan', 'Affiliation': 'National Heart Lung and Blood Institute, 9000 Rockville Pike, Bethesda, MD 20892, USA.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Rifai', 'Affiliation': ""Department of Laboratory Medicine, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}]",European heart journal,['10.1093/eurheartj/ehaa160']
367,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
368,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
369,31015198,Phase II Trial of Chemopreventive Effects of Levonorgestrel on Ovarian and Fallopian Tube Epithelium in Women at High Risk for Ovarian Cancer: An NRG Oncology Group/GOG Study.,"A large body of epidemiologic evidence has shown that use of progestin-containing preparations lowers ovarian cancer risk. The purpose of the current study was to gather further preclinical evidence supporting progestins as cancer chemopreventives by demonstrating progestin-activation of surrogate endpoint biomarkers pertinent to cancer prevention in the genital tract of women at increased risk of ovarian cancer. There were 64 women enrolled in a multi-institutional randomized trial who chose to undergo risk-reducing bilateral salpingo-oophorectomy (BSO) and to receive the progestin levonorgestrel or placebo for 4 to 6 weeks prior to undergoing BSO. The ovarian and fallopian tube epithelia (FTE) were compared immunohistochemically for effects of levonorgestrel on apoptosis (primary endpoint). Secondary endpoints included TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality. In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms. In the ovarian epithelium, treatment with levonorgestrel significantly decreased the proliferation index. The mean ovarian Ki-67 value in the placebo arm was 2.027 per 100 cells versus 0.775 per 100 cells in the levonorgestrel arm (two-sided  P  value via Mann-Whitney  U  test = 0.0114). The karyometric signature of nuclei in both the ovarian and FTE deviated significantly from normal controls (women at average risk of ovarian cancer), but was significantly less abnormal in women treated with levonorgestrel. These karyometric data further support the idea that progestins may clear genetically abnormal cells and act as chemopreventive agents against ovarian and fallopian tube cancer.",2019,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","['Women at High Risk for Ovarian Cancer', '64 women enrolled in a multi-institutional randomized trial who chose to']","['placebo', 'levonorgestrel', 'Levonorgestrel', 'progestin-containing preparations', 'undergo risk-reducing bilateral salpingo-oophorectomy (BSO', 'progestin levonorgestrel or placebo']","['ovarian and fallopian tube epithelia (FTE', 'Ovarian and Fallopian Tube Epithelium', 'proliferation index', 'TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality', 'mean ovarian Ki-67 value']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}]","[{'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",64.0,0.125864,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","[{'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois. grodriguez@northshore.org.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kauderer', 'Affiliation': 'NRG Oncology, Clinical trial Development Division, Biostatistics & Bioinformatics, Roswell Park Cancer Institute; Buffalo, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hunn', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Thaete', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Watkin', 'Affiliation': 'Department of Pathology, NorthShore University Health System, Evanston, Illinois.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Basil', 'Affiliation': 'TriHealth Hospitals, Cincinnati, Ohio.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hurteau', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Shashikant', 'Initials': 'S', 'LastName': 'Lele', 'Affiliation': 'Gynecologic Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Modesitt', 'Affiliation': 'Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'Department of Mathematics, University of Arizona, Department of Mathematics, Phoenix, Arizona.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bartels', 'Affiliation': 'Department of Optical Sciences, University of Arizona, Optical Sciences, Phoenix, Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0383']
370,32135381,The Impact of Lactobacillus Probiotics on the Gut Microbiota in Children With Short Bowel Syndrome.,"BACKGROUND


Children with short bowel syndrome (SBS) frequently struggle with malabsorption and poor growth. The intestinal microbiota plays an important role in gut function, and children with SBS have known deficiencies in some commensal gut microbes. One strategy to enhance the gut microbiota is by taking probiotics. However, the efficacy of this approach is not well established. We hypothesized that probiotic supplementation would result in increased levels of the supplemented bacteria and improved growth.
MATERIALS AND METHODS


Children with SBS who had weaned from parenteral nutrition but with suboptimal growth were randomized to receive probiotics (Lactobacillus rhamnosus and Lactobacillus johnsonii) or placebo daily for 2 mo. The gut microbiota from monthly stool samples were compared between groups using 16S ribosomal ribonucleic acid sequencing and quantitative polymerase chain reaction. Growth between groups was also compared. Statistical analysis was completed using Mann-Whitney, Kruskal-Wallis, and chi-square tests as appropriate.
RESULTS


Eighteen children with SBS completed the study (n = 9 per group). There were no significant changes to the major bacterial families in either group. Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P = 0.161). Median z scores for weight and length did not differ between groups at the beginning or end of the study.
CONCLUSIONS


The efficacy of daily probiotic use in children with intestinal failure is unknown. In this study, Lactobacillus probiotics did not result in a predictable change to the fecal microbiota or overall growth compared with placebo in these patients.",2020,"Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P ","['Children with SBS who had weaned from parenteral nutrition but with suboptimal growth', 'children with intestinal failure', 'Children with short bowel syndrome (SBS', 'Eighteen children with SBS completed the study (n\xa0=\xa09 per group', 'Children With Short Bowel Syndrome']","['placebo', 'probiotics (Lactobacillus rhamnosus and Lactobacillus johnsonii) or placebo', 'Lactobacillus Probiotics', 'probiotic supplementation']","['fecal microbiota or overall growth', 'Median relative abundance of Lactobacillus', 'Gut Microbiota', 'levels of the supplemented bacteria and improved growth', 'Median z scores for weight and length']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0445728', 'cui_str': 'Lactobacillus johnsonii'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",18.0,0.0555,"Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P ","[{'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Piper', 'Affiliation': 'Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: hannah.piper@cw.bc.ca.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Coughlin', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Van', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Channabasappa', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Andrew Y', 'Initials': 'AY', 'LastName': 'Koh', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Microbiology, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.024']
371,32013276,"Pulsed Radiofrequency on Thoracic Dorsal Root Ganglion Versus Thoracic Paravertebral Nerve for Chronic Postmastectomy Pain, A Randomized Trial: 6-Month Results.","BACKGROUND


Pharmacologic treatment is not successful in all cases of postmastectomy pain syndrome (PMPS). Some patients continue suffering pain while taking their medications, and others cannot tolerate the side effects of antineuropathic analgesics. Radiofrequency technology has provided promising results in the management of chronic neuropathic pain.
OBJECTIVES


Considering that affection of intercostobrachial nerves are the main reason behind PMPS, we aimed to evaluate and compare the analgesic efficacy of pulsed radiofrequency (PRF) when delivered either on thoracic dorsal root ganglion (DRG) of intercostobrachial nerves (thoracic DRG 2, 3, and 4) or their corresponding thoracic paravertebral nerves (PVNs).
STUDY DESIGN


Prospective randomized-controlled clinical trial.
SETTINGS


Interventional pain unit, tertiary center, university hospital.
METHODS


Sixty-four patients complaining of PMPS were randomized to either group DRG (n = 32) that received PRF on thoracic DRG, or group PVN (n = 32) that received PRF on thoracic PVN. The outcome variables were that the patients showed > 50% reduction in their visual analog scale (VAS) pain score; the VAS pain score and global perceived effect (GPE) was evaluated during a 6-month follow-up period.
RESULTS


The percentage of patients who showed > 50% reduction of their VAS pain score was significantly higher in group DRG compared with group PVN, assessed at 4 and 6 months postprocedure (23/29:79.3% vs. 13/29:44.8%; P = 0.007) and (22/29:75.9% vs. 7/29:24.1%; P < 0.001), respectively, however, the 2 groups did not significantly differ at 1, 2, and 3 months postprocedure (DRG vs. PVN), (21/29: 72.4% vs. 21/29: 72.4%; P = 0.542), (24/29: 82.8% vs. 23/29: 79.9%; P = 0.778), and (24/29: 82.8% vs. 19/29: 65.5%; P = 0.136), respectively. There was a statistically significant reduction of VAS pain score at 4 and 6 months (DRG vs. PVN, mean ± standard deviation, 2.9 ± 2 vs. 3.9 ± 1.5; mean difference (95% confidence interval), 1 (0.06:1.9); P = 0.038; 3 ± 1.94 vs. 5.1 ± 1.5; mean difference (95% confidence interval), 1.9 (1:2.9); P < 0.001, respectively), however, the 2 groups did not significantly differ at 1, 2, and 3 months postprocedure. With regard to the patient's satisfaction (i.e., GPE), assessed at 3 and 6 months postprocedure, there was a significantly higher satisfaction in group DRG compared with group PVN (median [interquartile range (IQR)], 6 (5:7) vs. 3 (2:4);P < 0.001), however, the patient's satisfaction was similar between groups at 3 months postprocedure: median (IQR), 6 (4:7) vs. 6 (5:6); P = 0.327.
LIMITATIONS


The study follow-up period is limited to 6 months only.
CONCLUSIONS


PRF of both the thoracic DRG and the thoracic PVN are effective treatments for PMPS; however, PRF of DRG provided a better long-term analgesic effect. Nevertheless, given the inherent risk of performing thoracic foraminal interventions and the technical difficulty of targeting thoracic DRG, we recommend that PRF of DRG should be reserved for cases that failed to gain adequate response to PRF of thoracic PVN in conjunction with medical treatment.
KEY WORDS


Postmastectomy pain syndrome, radiofrequency, dorsal root ganglion, paravertebral nerve.",2020,"The percentage of patients who showed > 50% reduction of their VAS pain score was significantly higher in group DRG compared with group PVN, assessed at 4 and 6 months postprocedure (23/29:79.3% vs. 13/29:44.8%; P = 0.007) and (22/29:75.9% vs. 7/29:24.1%; P < 0.001), respectively, however, the 2 groups did not significantly differ at 1, 2, and 3 months postprocedure (DRG vs. PVN), (","['Interventional pain unit, tertiary center, university hospital', 'Sixty-four patients complaining of PMPS']","['Radiofrequency technology', 'pulsed radiofrequency (PRF', 'Pulsed Radiofrequency', 'PRF on thoracic DRG, or group PVN', 'group DRG', 'PRF on thoracic PVN']","['visual analog scale (VAS) pain score; the VAS pain score and global perceived effect (GPE', ""patient's satisfaction"", 'VAS pain score', 'analgesic efficacy', 'Thoracic Dorsal Root Ganglion']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0011928', 'cui_str': 'DRG'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0017070', 'cui_str': 'Dorsal Root Ganglia'}]",,0.137658,"The percentage of patients who showed > 50% reduction of their VAS pain score was significantly higher in group DRG compared with group PVN, assessed at 4 and 6 months postprocedure (23/29:79.3% vs. 13/29:44.8%; P = 0.007) and (22/29:75.9% vs. 7/29:24.1%; P < 0.001), respectively, however, the 2 groups did not significantly differ at 1, 2, and 3 months postprocedure (DRG vs. PVN), (","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'South Egypt Cancer Institute, Assuit University, Egypt.'}, {'ForeName': 'Sahar Abdel Baky', 'Initials': 'SAB', 'LastName': 'Mohamed', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assuit University, Assuit, Egypt.'}, {'ForeName': 'Kawser Hofny', 'Initials': 'KH', 'LastName': 'Mohamed', 'Affiliation': 'Department of Anesthesia and Intensive Care, Assuit University Hospital, Assuit University, Assuit, Egypt.'}, {'ForeName': 'Taha Abd Elrazek', 'Initials': 'TAE', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assuit University, Assuit, Egypt.'}, {'ForeName': 'Hanan Ahmed', 'Initials': 'HA', 'LastName': 'Eltyb', 'Affiliation': 'Department of Medical Oncology, South Egypt Cancer Institute, Assuit University; Assuit, Egypt.'}]",Pain physician,[]
372,32013277,"Effects of Intraoperative Low-Dose Ketamine on Persistent Postsurgical Pain after Breast Cancer Surgery: A Prospective, Randomized, Controlled, Double-Blind Study.","BACKGROUND


Compared to acute postsurgical pain, studies regarding the role of ketamine in persistent postsurgical pain (PPSP) are limited.
OBJECTIVES


The aim of this clinical trial was to test if intraoperative low-dose ketamine without postoperative infusion would reduce PPSP development after breast cancer surgery.
STUDY DESIGN


We used a randomized, double-blinded, placebo study design.
SETTING


This study was conducted at Pusan National University Hospital, Republic of Korea, between December 2013 and August 2016.
METHODS


A total of 184 patients scheduled for breast cancer surgery were randomly assigned to either the control or ketamine group. Before skin incision, a bolus (0.5 mg/kg of ketamine or placebo), followed by a continuous infusion (0.12 mg/kg/h of ketamine or placebo), was administered until the end of the surgery. The patients were interviewed via telephone 1, 3, and 6 months after surgery. The first question was whether the patient had surgery-related pain. If answered affirmatively, questions from the Numeric Rating Scale for pain at rest (NRSr) and for coughing (NRSd) were also asked. Our primary outcome was the incidence of PPSP at 3 months after surgery.
RESULTS


For PPSP analysis, 168 patients were included. The number of patients who experienced pain was significantly lower in the ketamine group at 3 months (86.9% in the control group vs 69.0% in the ketamine group, P = .005) postoperatively. However, the NRSr and NRSd did not differ between the groups throughout the follow-up.
LIMITATIONS


There were no postoperative low-dose ketamine infusion groups to compare due to hospital regulations. Dosage of ketamine was too low to reduce the severity of PPSP. And by using propofol and remifentanil for anesthesia, different results can be deduced with volatile anesthetics. Data from written questionnaires would have been more specific than telephone interviews for long-term assessment.
CONCLUSIONS


Though intraoperative low-dose ketamine without postoperative infusion significantly reduced the incidence of PPSP up to 3 months after breast cancer surgery, it failed to reduce clinically significant PPSP and improve patients' quality of life.
KEY WORDS


Analgesia, breast cancer, chronic pain, ketamine, mastectomy, morphine, pain, postoperative, propofol.",2020,"The number of patients who experienced pain was significantly lower in the ketamine group at 3 months (86.9% in the control group vs 69.0% in the ketamine group, P = .005) postoperatively.","['after breast cancer surgery', 'This study was conducted at Pusan National University Hospital, Republic of Korea, between December 2013 and August 2016', '184 patients scheduled for breast cancer surgery', '168 patients were included', 'after Breast Cancer Surgery']","['Intraoperative Low-Dose Ketamine', 'control or ketamine', 'intraoperative low-dose ketamine', 'placebo', 'ketamine or placebo', 'propofol and remifentanil', 'ketamine']","['Numeric Rating Scale for pain at rest (NRSr) and for coughing (NRSd', 'severity of PPSP', 'number of patients who experienced pain', 'PPSP development', ""patients' quality of life"", 'NRSr and NRSd', 'Analgesia, breast cancer, chronic pain, ketamine, mastectomy, morphine, pain, postoperative, propofol', 'incidence of PPSP', 'Postsurgical Pain']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0222045'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0034380'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",184.0,0.441366,"The number of patients who experienced pain was significantly lower in the ketamine group at 3 months (86.9% in the control group vs 69.0% in the ketamine group, P = .005) postoperatively.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Medical Research Institute, Pusan National University Hospital, Busan.'}, {'ForeName': 'Ah-Reum', 'Initials': 'AR', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Medical Research Institute, Pusan National University Hospital, Busan.'}, {'ForeName': 'Kyung-Hoon', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University, Yangsan, Republic of Korea.'}, {'ForeName': 'Eun-A', 'Initials': 'EA', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Hanyang Rheumatis Hospital, Busan.'}, {'ForeName': 'Hyeon Jeong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Medical Research Institute, Pusan National University Hospital, Busan.'}, {'ForeName': 'Haekyu', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Medical Research Institute, Pusan National University Hospital, Busan.'}, {'ForeName': 'Eunsoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Medical Research Institute, Pusan National University Hospital, Busan.'}, {'ForeName': 'Ji-Seok', 'Initials': 'JS', 'LastName': 'Baik', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Medical Research Institute, Pusan National University Hospital, Busan.'}, {'ForeName': 'Choongrak', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Department of Statistics, Pusan National University, Busan, Republic of Korea.'}]",Pain physician,[]
373,32214139,"Epidural bolus versus continuous epidural infusion analgesia on optic nerve sheath diameter in paediatric patients: A prospective, double-blind, randomised trial.","The use of programmed intermittent epidural bolus for postoperative analgesia may have greater analgesic efficacy than continuous epidural infusion. However, the rapid delivery speed used with an epidural bolus is more likely to increase intracranial pressure. We compared the effects of lumbar epidural bolus versus continuous infusion epidural analgesia on intracranial pressure in children using optic nerve sheath diameter as a marker. We randomly assigned 40 paediatric patients to bolus or infusion groups. Epidural analgesia (0.15% ropivacaine 0.3 ml·kg -1 ) was administered via bolus or infusion. Ultrasonography was used to measure the optic nerve sheath diameter before (T0), at 3 min (T1), 10 min (T2), and 70 min (T3) after starting the pump. There were statistically significant between-group differences in optic nerve sheath diameter over time (P Group x Time  = 0.045). From T0-T3, the area under the curve values were similar between the two groups. Although there were differences in the patterns of optic nerve sheath diameter change according to the delivery mode, the use of lumbar epidural bolus did not increase the risk of intracranial pressure increase over that of continuous infusion. Further research is needed to investigate intracranial pressure changes after continuous application of each delivery mode.",2020,There were statistically significant between-group differences in optic nerve sheath diameter over time (P Group x Time  = 0.045).,"['paediatric patients', '40 paediatric patients to bolus or infusion groups', 'children using optic nerve sheath diameter as a marker']","['lumbar epidural bolus versus continuous infusion epidural analgesia', 'Ultrasonography', 'Epidural bolus versus continuous epidural infusion analgesia', 'ropivacaine', 'Epidural analgesia']","['optic nerve sheath diameter over time', 'intracranial pressure', 'risk of intracranial pressure increase', 'analgesic efficacy']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0151740', 'cui_str': 'Intracranial Pressure Increase'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",40.0,0.104068,There were statistically significant between-group differences in optic nerve sheath diameter over time (P Group x Time  = 0.045).,"[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Severance Hospital and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Severance Hospital and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Min-Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Severance Hospital and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Seon Ju', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Severance Hospital and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Jeehyun', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Severance Hospital and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Do-Hyeong', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul, 06273, Republic of Korea.'}, {'ForeName': 'Yong Seon', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Severance Hospital and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. YSCHOI@yuhs.ac.'}]",Scientific reports,['10.1038/s41598-020-62273-8']
374,32214138,Rosuvastatin alters the genetic composition of the human gut microbiome.,"The gut microbiome contributes to the variation of blood lipid levels, and secondary bile acids are associated with the effect of statins. Yet, our knowledge of how statins, one of our most common drug groups, affect the human microbiome is scarce. We aimed to characterize the effect of rosuvastatin on gut microbiome composition and inferred genetic content in stool samples from a randomized controlled trial (n = 66). No taxa were significantly altered by rosuvastatin during the study. However, rosuvastatin-treated participants showed a reduction in the collective genetic potential to transport and metabolize precursors of the pro-atherogenic metabolite trimethylamine-N-oxide (TMAO, p < 0.01), and an increase of related metabolites betaine and γ-butyrobetaine in plasma (p < 0.01). Exploratory analyses in the rosuvastatin group showed that participants with the least favorable treatment response (defined as < median change in high-density/low-density lipoprotein (HDL/LDL) ratio) showed a marked increase in TMAO-levels compared to those with a more favorable response (p < 0.05). Our data suggest that while rosuvastatin has a limited effect on gut microbiome composition, it could exert broader collective effects on the microbiome relevant to their function, providing a rationale for further studies of the influence of statins on the gut microbiome.",2020,No taxa were significantly altered by rosuvastatin during the study.,['stool samples from a randomized controlled trial (n\u2009=\u200966'],"['Rosuvastatin', 'rosuvastatin']","['related metabolites betaine and γ-butyrobetaine in plasma', 'TMAO-levels', 'collective genetic potential to transport and metabolize precursors of the pro-atherogenic metabolite trimethylamine-N-oxide']","[{'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0061030', 'cui_str': 'deoxy-carnitine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}]",,0.018774,No taxa were significantly altered by rosuvastatin during the study.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kummen', 'Affiliation': 'Norwegian PSC Research Center, Department of Transplantation Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ole Geir', 'Initials': 'OG', 'LastName': 'Solberg', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Storm-Larsen', 'Affiliation': 'Norwegian PSC Research Center, Department of Transplantation Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Holm', 'Affiliation': 'Norwegian PSC Research Center, Department of Transplantation Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Asgrimur', 'Initials': 'A', 'LastName': 'Ragnarsson', 'Affiliation': 'Department of Radiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Trøseid', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Vestad', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Skårdal', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Yndestad', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Asbjørn', 'Initials': 'A', 'LastName': 'Svardal', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rolf K', 'Initials': 'RK', 'LastName': 'Berge', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'Karlsen', 'Affiliation': 'Norwegian PSC Research Center, Department of Transplantation Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aaberge', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Hov', 'Affiliation': 'Norwegian PSC Research Center, Department of Transplantation Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway. j.e.r.hov@medisin.uio.no.'}]",Scientific reports,['10.1038/s41598-020-62261-y']
375,32092608,Microbreaks in Laparoscopic Appendectomy have No Effect on Surgeons' Performance and Well-being.,"BACKGROUND


Musculoskeletal fatigue and pain as a consequence of performing surgery is found in 70%-87% of surgeons. The aim of this study was to examine the effect of microbreaks on surgeons' performance and well-being during laparoscopic appendectomy.
MATERIALS AND METHODS


The study was a blinded randomized crossover trial. Twelve surgeons were tested at three time points: Before surgery (baseline), after surgery without intervention, and after surgery where microbreaks were used every 10 min for 10 s. The musculoskeletal endurance test was used as the primary outcome. Performance was assessed by procedure length and a manual precision test. The surgeons' well-being was measured by level of exhaustion rated on the Borg CR10 scale and visual analog scale ratings for musculoskeletal discomfort in the neck, shoulders, back, wrists, and legs.
RESULTS


No significant differences were found in musculoskeletal endurance, procedure time, or the manual precision test. The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03). However, no significant difference was found between the two (P = 0.25). There was a significant increase from baseline regarding self-reported musculoskeletal discomfort in the back, shoulders, and legs after surgery but no significant differences between procedures with and without microbreaks.
CONCLUSIONS


This study did not find a positive effect of microbreaks on laparoscopic appendectomy. Exhaustion and discomfort were present after surgery, demonstrating that short surgical procedures (less than 60 min) can result in fatigue in surgeons.",2020,The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03).,[],['laparoscopic appendectomy'],"['musculoskeletal discomfort', 'level of exhaustion', 'musculoskeletal endurance, procedure time, or the manual precision test', 'Exhaustion and discomfort', 'level of exhaustion rated on the Borg CR10 scale and visual analog scale ratings for musculoskeletal discomfort in the neck, shoulders, back, wrists, and legs']",[],"[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}]","[{'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",12.0,0.198755,The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03).,"[{'ForeName': 'Laurits Schou', 'Initials': 'LS', 'LastName': 'Kromberg', 'Affiliation': 'Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark. Electronic address: laurits.s.hansen@gmail.com.'}, {'ForeName': 'Niels Vinkel', 'Initials': 'NV', 'LastName': 'Kildebro', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Laura Quitzau', 'Initials': 'LQ', 'LastName': 'Mortensen', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Ilda', 'Initials': 'I', 'LastName': 'Amirian', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.007']
376,31703056,Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy for Lumbar Disc Herniation: Two-Year Results of a Randomized Controlled Trial.,"STUDY DESIGN


A prospective randomized controlled study.
OBJECTIVE


To clarify whether percutaneous transforaminal endoscopic discectomy (PTED) has better clinical outcomes and less surgical trauma compared with microendoscopic discectomy (MED).
SUMMARY OF BACKGROUND DATA


Two kinds of minimally invasive spine surgeries, PTED and MED, are now widely used for the treatment of lumbar disc herniation (LDH). It is still a controversial issue to choose the proper surgical approach.
METHODS


In this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imaging-confirmed LDH, and were randomly allocated to PTED or MED group. The primary outcome was the score of Oswestry Disability Index (ODI) and the secondary outcomes included the score of Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain and physical function scales, European Quality of Life-5 Dimensions, and Visual Analogue Scales for back pain and leg pain.
RESULTS


A total of 250 participants were randomly assigned to two treatment groups, 241 of that received the specific surgical procedure. Two hundred twenty-two patients (92.1%) have completed the 2-year follow-up. Both the primary and secondary outcomes did not differ significantly between the two treatment groups at each prespecified follow-up time (P > 0.05). For PTED, the postoperative improvement of ODI score in the median herniation subgroup was less compared with paramedian subgroup. For MED, less improvement of ODI score was found in far-lateral herniation subgroup compared with paramedian subgroup. Total complication rate over the course of 2 year was 13.44% in PTED group and 15.57% in MED group (P = 0.639). Ten cases (8.40%) in PTED group and five cases (4.10%) in MED group suffered from residue/recurrence of herniation, for which reoperation was required.
CONCLUSION


Over the 2-year follow-up period, PTED did not show superior clinical outcomes and did not appear to be safer procedure for patients with LDH compared with MED. PTED had inferior results for median disc herniation, whereas MED did not appear to be the best option for far-lateral disc herniation.
LEVEL OF EVIDENCE


2.",2020,Both the primary and secondary outcomes did not differ significantly between the two treatment groups at each prespecified follow-up time (P > 0.05).,"['222 patients (92.1%) have completed the 2-year follow-up', 'lumbar disc herniation (LDH', 'patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imaging-confirmed LDH', '250 participants', 'Lumbar Disc Herniation']","['Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy', 'percutaneous transforaminal endoscopic discectomy (PTED', 'specific surgical procedure']","['Total complication rate', 'score of Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain (SF36-BP) and physical function (SF36-PF) scales, European Quality of Life-5 Dimensions (EQ-5D), Visual Analogue Scales for back pain (VAS-back) and leg pain (VAS-leg', 'ODI score', 'median disc herniation', 'score of Oswestry Disability Index (ODI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",250.0,0.144592,Both the primary and secondary outcomes did not differ significantly between the two treatment groups at each prespecified follow-up time (P > 0.05).,"[{'ForeName': 'Zihao', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Liangming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Peigen', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Qiyou', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ruiqiang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Shu', 'Affiliation': ''}, {'ForeName': 'Shangfu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Bu', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Pang', 'Affiliation': ''}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Rong', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003314']
377,32039215,A ngiotensin Converting Enzyme Inhibitors  C ombined with  E xercise for Hypertensive  S eniors (The ACES Trial): Study Protocol of a Randomized Controlled Trial.,"Prior evidence suggests that the choice of antihypertensive medication may influence functional status among older adults with hypertension, particularly in conjunction with exercise. In particular, angiotensin converting enzyme (ACE) inhibitors have shown potential to positively influence function. However, randomized, controlled trials are needed to confirm this hypothesis. This paper outlines an RCT designed to determine if choice of first-line antihypertensive medication influences functional and cardiovascular risk factor responses to exercise among older adults with hypertension. Two hundred and thirteen inactive, community-dwelling adults ≥60 years of age with hypertension and functional limitations will be recruited to engage in a 32-week intervention study. Participants will be randomized to one of three first-line antihypertensive agents: (1) the ACE inhibitor perindopril, (2) the AT1 receptor antagonist losartan, or (3) the thiazide diuretic hydrochlorothiazide (HCTZ). Six weeks after randomization, participants will begin a 20-week structured aerobic exercise intervention. Participants will perform two 45-min center-based sessions coupled with 60 min of home-based walking per week. The primary aim is to determine if perindopril improves self-paced gait speed when compared with losartan and HCTZ. The secondary aim is to determine the relative effect of perindopril on secondary outcomes such as: (a) exercise capacity, (b) body mass and composition, and (c) circulating indices of cardiovascular risk. This RCT is expected to identify differential effects of first-line antihypertensive medications when combined with physical exercise thus have potential implications for antihypertensive prescription guidelines for older adults.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT03295734.",2019,"Prior evidence suggests that the choice of antihypertensive medication may influence functional status among older adults with hypertension, particularly in conjunction with exercise.","['Two hundred and thirteen inactive, community-dwelling adults ≥60 years of age with hypertension and functional limitations will be recruited to engage in a 32-week intervention study', 'older adults', 'Hypertensive  S eniors (The ACES Trial', 'older adults with hypertension']","['ACE inhibitor perindopril, (2) the AT1 receptor antagonist losartan, or (3) the thiazide diuretic hydrochlorothiazide (HCTZ', 'losartan and HCTZ', 'structured aerobic exercise intervention', 'antihypertensive medication', 'perindopril', 'angiotensin converting enzyme (ACE) inhibitors']","['self-paced gait speed', 'secondary outcomes such as: (a) exercise capacity, (b) body mass and composition, and (c) circulating indices of cardiovascular risk']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0012802', 'cui_str': 'Benzothiadiazine Diuretics'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0795336,"Prior evidence suggests that the choice of antihypertensive medication may influence functional status among older adults with hypertension, particularly in conjunction with exercise.","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Harper', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Liliana C', 'Initials': 'LC', 'LastName': 'Baptista', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Roberts', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Wherry', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, United States.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Boxer', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, United States.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Hildreth', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, United States.'}, {'ForeName': 'Regina S', 'Initials': 'RS', 'LastName': 'Seay', 'Affiliation': 'Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'P Hunter', 'Initials': 'PH', 'LastName': 'Allman', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Christy S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, United States.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Buford', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}]",Frontiers in medicine,['10.3389/fmed.2019.00327']
378,32043907,Underlying Immune Disorder May Predispose Some Transthyretin Amyloidosis Subjects to Inotersen-Mediated Thrombocytopenia.,"Inotersen, a 2'-O-methoxyethyl (2'-MOE) phosphorothioate antisense oligonucleotide, reduced disease progression and improved quality of life in patients with hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN) in the NEURO-TTR and NEURO-TTR open-label extension (OLE) trials. However, 300 mg/week inotersen treatment was associated with platelet count reductions in several patients. Mean platelet counts in patients in the NEURO-TTR-inotersen group remained ≥140 × 10 9 /L in 50% and ≥100 × 10 9 /L in 80% of the subjects. However, grade 4 thrombocytopenia (<25 × 10 9 /L) occurred in three subjects in NEURO-TTR trial, and one of these suffered a fatal intracranial hemorrhage. The two others were treated successfully with corticosteroids and discontinuation of inotersen. Investigations in a subset of subjects in NEURO-TTR ( n  = 17 placebo;  n  = 31 inotersen) and OLE ( n  = 33) trials ruled out direct myelotoxicity, consumptive coagulopathy, and heparin-induced thrombocytopenia. Antiplatelet immunoglobulin G (IgG) antibodies were detected at baseline in 5 of 31 (16%) inotersen-treated subjects in NEURO-TTR, 4 of whom eventually developed grade 1 or 2 thrombocytopenia while on the drug. In addition, 24 subjects in the same group developed treatment-emergent antiplatelet IgG antibodies, of which 2 developed grade 2, and 3 developed grade 4 thrombocytopenia. Antiplatelet IgG antibodies in two of the three grade 4 thrombocytopenia subjects targeted GPIIb/IIIa. Plasma cytokines previously implicated in immune dysregulation, such as interleukin (IL)-23 and a proliferation-inducing ligand (APRIL) were often above the normal range at baseline. Collectively, these findings suggest an underlying immunologic dysregulation predisposing some individuals to immune-mediated thrombocytopenia during inotersen treatment.",2020,"Antiplatelet immunoglobulin G (IgG) antibodies were detected at baseline in 5 of 31 (16%) inotersen-treated subjects in NEURO-TTR, 4 of whom eventually developed grade 1 or 2 thrombocytopenia while on the drug.","['Underlying Immune Disorder', '10 9', 'L in 50% and ≥100', 'patients with hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN']","['placebo', 'heparin-induced thrombocytopenia', 'OLE']","['Mean platelet counts', 'platelet count reductions', 'disease progression and improved quality of life', 'grade 4 thrombocytopenia', 'Antiplatelet IgG antibodies', 'fatal intracranial hemorrhage', 'Antiplatelet immunoglobulin G (IgG) antibodies', 'treatment-emergent antiplatelet IgG antibodies']","[{'cui': 'C0021053', 'cui_str': 'Immune System Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C2751492', 'cui_str': 'Familial Transthyretin Cardiac Amyloidosis'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C1292065', 'cui_str': 'Antibody, immunoglobulin G class'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0329317,"Antiplatelet immunoglobulin G (IgG) antibodies were detected at baseline in 5 of 31 (16%) inotersen-treated subjects in NEURO-TTR, 4 of whom eventually developed grade 1 or 2 thrombocytopenia while on the drug.","[{'ForeName': 'PadmaKumar', 'Initials': 'P', 'LastName': 'Narayanan', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Curtis', 'Affiliation': 'Platelet and Neutrophil Immunology Laboratory, Versiti Wisconsin, Inc., Milwaukee, Wisconsin.'}, {'ForeName': 'Lijiang', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Schneider', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Tami', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Paz', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Sebastien A', 'Initials': 'SA', 'LastName': 'Burel', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Li-Jung', 'Initials': 'LJ', 'LastName': 'Tai', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Machemer', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'T Jesse', 'Initials': 'TJ', 'LastName': 'Kwoh', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Sanford J', 'Initials': 'SJ', 'LastName': 'Shattil', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Engelhardt', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Henry', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Brett P', 'Initials': 'BP', 'LastName': 'Monia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, California.'}]",Nucleic acid therapeutics,['10.1089/nat.2019.0829']
379,29728704,The novel ghrelin receptor inverse agonist PF-5190457 administered with alcohol: preclinical safety experiments and a phase 1b human laboratory study.,"Rodent studies indicate that ghrelin receptor blockade reduces alcohol consumption. However, no ghrelin receptor blockers have been administered to heavy alcohol drinking individuals. Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects of a novel ghrelin receptor inverse agonist, PF-5190457, when co-administered with alcohol. We tested the effects of PF-5190457 combined with alcohol on locomotor activity, loss-of-righting reflex (a measure of alcohol sedative actions), and on blood PF-5190457 concentrations in rats. Then, we performed a single-blind, placebo-controlled, within-subject human study with PF-5190457 (placebo/0 mg b.i.d., 50 mg b.i.d., 100 mg b.i.d.). Twelve heavy drinkers during three identical visits completed an alcohol administration session, subjective assessments, and an alcohol cue-reactivity procedure, and gave blood samples for PK/PD testing. In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex. Alcohol did not affect blood PF-5190457 concentrations. In humans, all adverse events were mild or moderate and did not require discontinuation or dose reductions. Drug dose did not alter alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood during alcohol administration. Potential PD markers of PF-5190457 were acyl-to-total ghrelin ratio and insulin-like growth factor-1. PF-5190457 (100 mg b.i.d.) reduced alcohol craving during the cue-reactivity procedure. This study provides the first translational evidence of safety and tolerability of the ghrelin receptor inverse agonist PF-5190457 when co-administered with alcohol. PK/PD/behavioral findings support continued research of PF-5190457 as a potential pharmacological agent to treat alcohol use disorder.",2020,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","['rats', 'Twelve heavy drinkers']","['PF-5190457', 'placebo', 'PF-5190457 (placebo/0', 'ghrelin receptor inverse agonist', 'PF-5190457 combined with alcohol']","['reduced alcohol craving', 'alcohol consumption', 'locomotor activity, loss-of-righting reflex', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects', 'alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood', 'blood PF-5190457 concentrations', 'locomotor activity or loss-of-righting reflex']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0234156', 'cui_str': 'Righting Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005768'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}]",,0.0182118,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jenica D', 'Initials': 'JD', 'LastName': 'Tapocik', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mwlod', 'Initials': 'M', 'LastName': 'Ghareeb', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Dias', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Le', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA. lorenzo.leggio@nih.gov.'}]",Molecular psychiatry,['10.1038/s41380-018-0064-y']
380,32220283,"Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial.","BACKGROUND


The Butantan Institute has manufactured a lyophilised tetravalent live-attenuated dengue vaccine Butantan-DV, which is analogous to the US National Institutes of Health (NIH) TV003 admixture. We aimed to assess the safety and immunogenicity of Butantan-DV.
METHODS


We did a two-step, double-blind, randomised placebo-controlled phase 2 trial at two clinical sites in São Paulo, Brazil. We recruited healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded. Step A was designed as a small bridge-study between Butantan-DV and TV003 in DENV-naive participants. In step A, we planned to randomly assign 50 dengue virus (DENV)-naive individuals to receive two doses of Butantan-DV, TV003, or placebo, given 6 months apart. In step B, we planned to randomly assign 250 participants (DENV-naive and DENV-exposed) to receive one dose of Butantan-DV or placebo. Participants were randomly assigned, by computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo. Participants and study staff were unaware of treatment allocation. The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat. The primary immunogenicity outcome was seroconversion rates of the DENV-1-4 serotypes measured 91 days after the first vaccination, analysed in the per-protocol population, which included all participants in step A, and all participants included in step B who completed all study visits with serology sample collection. This trial is registered with ClinicalTrials.gov, NCT01696422.
FINDINGS


Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants. Of the 155 DENV-naive participants, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received placebo. Of the 145 DENV-exposed participants, 113 (78%) received Butantan-DV, three (2%) received TV003, and 29 (20%) received placebo. Butantan-DV and TV003 were both immunogenic, well-tolerated, and no serious adverse reactions were observed. In step A, rash was the most frequent adverse event (16 [845] of 19 participants in the Butantan-DV group and 13 [76%] of 17 participants in the TV003 group). Viraemia was similar between the Butantan-DV and TV003 groups. Of the 85 DENV-naive participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis and thus were included in the per-protocol analysis population, 74 (87%) achieved seroconversion to DENV-1, 78 (92%) to DENV-2, 65 (76%) to DENV-3, and 76 (89%) to DENV-4. Of the 101 DENV-exposed participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis, 82 (81%) achieved seroconversion to DENV-1, 79 (78%) to DENV-2, 83 (82%) to DENV-3, and 78 (77%) to DENV-4.
INTERPRETATION


Butantan-DV and TV003 were safe and induced robust, balanced neutralising antibody responses against the four DENV serotypes. Efficacy evaluation of the Butantan-DV vaccine is ongoing.
FUNDING


Intramural Research Program US NIH National Institute of Allergy and Infectious Diseases, Brazilian National Bank for Economic and Social Development, Fundação de Amparo à Pesquisa do Estado de São Paulo, and Fundação Butantan.",2020,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","['healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded', 'adults in Brazil', 'Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants']","['placebo', 'Butantan-DV or placebo', 'Butantan-DV, TV003, or placebo', 'tetravalent, live-attenuated dengue vaccine Butantan-DV', 'computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo', 'Butantan-DV vaccine']","['Safety and immunogenicity', 'Viraemia', 'seroconversion to DENV-1', 'frequency of solicited and unsolicited local and systemic adverse reactions', 'seroconversion rates of the DENV-1-4 serotypes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0580278', 'cui_str': '4 serotype'}]",300.0,0.486172,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","[{'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexander Roberto', 'Initials': 'AR', 'LastName': 'Precioso', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil; Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil. Electronic address: alexander.precioso@butantan.gov.br.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Thomé', 'Affiliation': 'Preventive Medicine Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Patrícia Emília', 'Initials': 'PE', 'LastName': 'Braga', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Tazio', 'Initials': 'T', 'LastName': 'Vanni', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Lúcia M A', 'Initials': 'LMA', 'LastName': 'Campos', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Mondini', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Graça Salomão', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'da Silva', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Heloisa M', 'Initials': 'HM', 'LastName': 'Espinola', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Joane', 'Initials': 'J', 'LastName': 'do Prado Santos', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Cecilia L S', 'Initials': 'CLS', 'LastName': 'Santos', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'Maria do Carmo S T', 'Initials': 'MDCST', 'LastName': 'Timenetsky', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'João Luiz', 'Initials': 'JL', 'LastName': 'Miraglia', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Neuza M F', 'Initials': 'NMF', 'LastName': 'Gallina', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weiskopf', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sette', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Raphaella', 'Initials': 'R', 'LastName': 'Goulart', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rafael Tavares', 'Initials': 'RT', 'LastName': 'Salles', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alvino', 'Initials': 'A', 'LastName': 'Maestri', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Adriana Maluf Elias', 'Initials': 'AME', 'LastName': 'Sallum', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sylvia Costa Lima', 'Initials': 'SCL', 'LastName': 'Farhat', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Neusa K', 'Initials': 'NK', 'LastName': 'Sakita', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana C O A', 'Initials': 'JCOA', 'LastName': 'Ferreira', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cassia G T', 'Initials': 'CGT', 'LastName': 'Silveira', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Priscilla R', 'Initials': 'PR', 'LastName': 'Costa', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isaias', 'Initials': 'I', 'LastName': 'Raw', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Kalil', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30023-2']
381,31407810,"Randomised clinical trial: a placebo-controlled study of subcutaneous or intradermal NEXVAX2, an investigational immunomodulatory peptide therapy for coeliac disease.","BACKGROUND


Nexvax2 contains three gluten-derived peptides, intended to tolerize coeliac disease patients to gluten. Sequences cover six epitopes that trigger immune activation in human leucocyte antigen-DQ2.5-positive patients, most notably after an initial dose. Patients experience gastrointestinal symptoms with increases in serum interleukin-2. Consistent with Nexvax2's induction of non-responsiveness, reactivity disappears after repeated doses, or is avoided with gradual dose escalation. Early clinical trials used intradermal dosing, but pharmacokinetics and rapid onset of effect suggest that subcutaneous delivery may also be effective.
AIMS


To document the relative bioavailability of Nevax2 peptides after subcutaneous and intradermal dosing, and the tolerability and ability of subcutaneous dosing to induce non-responsiveness to Nexvax2 peptides.
METHODS


A randomised, double-blind, placebo-controlled study was conducted to assess plasma pharmacokinetics after subcutaneous and intradermal Nexvax2 dosing in HLA DQ2.5-positive patients, who had symptoms after an oral gluten challenge. Randomisation was to semi-weekly Nexvax2 (n = 12) or placebo (n = 2) injections, over a 5-week subcutaneous dose escalation and 2-week maintenance period, the latter with four doses of 900 µg, two subcutaneous and two intradermal. Post-dose circulating peptide and interleukin-2 levels were assessed. Investigators recorded adverse events experienced by patients.
RESULTS


Subcutaneous dosing resulted in slightly greater exposure. Interleukin-2 responses were seen with the gluten challenge but not after subcutaneous or intradermal dosing of 900 µg. Adverse events were generally mild and self-limited.
CONCLUSIONS


Subcutaneous and intradermal dosing of Nexvax2 yield similar bioavailability of constituent peptides; subcutaneous dose escalation avoids an immune response to dominant gluten epitopes.",2019,Interleukin-2 responses were seen with the gluten challenge but not after subcutaneous or intradermal dosing of 900 µg.,"['coeliac disease', 'HLA DQ2.5-positive patients, who had symptoms after an oral gluten challenge']","['subcutaneous and intradermal Nexvax2', 'placebo', 'subcutaneous or intradermal NEXVAX2']","['Interleukin-2 responses', 'plasma pharmacokinetics', 'serum interleukin-2', 'Adverse events']","[{'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.34733,Interleukin-2 responses were seen with the gluten challenge but not after subcutaneous or intradermal dosing of 900 µg.,"[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Truitt', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'A James M', 'Initials': 'AJM', 'LastName': 'Daveson', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Hooi C', 'Initials': 'HC', 'LastName': 'Ee', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Goel', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'Prometrika, LLC, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Neff', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Anderson', 'Affiliation': 'ImmusanT, Inc., Cambridge, Massachusetts, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15435']
382,32186967,Self-Hypnosis for Sleep Disturbances in Menopausal Women.,"Poor sleep is one of the most frequent health concerns among menopausal women. All stages of sleep can be impacted by the menopause transition. Negative outcomes of poor sleep are multidimensional and include poor physical, psychological, cognition, and social outcomes. Hypnosis is a nonpharmacological treatment for poor sleep and hot flashes in menopausal women. The goal of hypnosis is to educate and train subjects to perform self-hypnosis to alleviate the underlying symptom. The use of hypnosis as a treatment for poor sleep has shown benefits for both acute and chronic insomnia. Initial findings from the National Center for Complementary and Integrative Health (NCCIH) Hypnosis Intervention for Sleep in Menopause: Examination of Optimal Dose and Method of Delivery randomized control trial of 90 women were presented. Results showed that program and treatment satisfaction were high in all groups, adherence to daily practice met or exceeded adherence benchmarks. There were significant reduction of poor sleep quality in all groups with a significant increase in minutes slept in all groups. The majority of women also showed clinical improvements of duration. There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time. Overall, the use of self-hypnosis as a treatment program for sleep problems related to menopause was acceptable for women. Data further support that hypnosis is a promising technique to improve sleep in menopausal women with sleep and hot flashes. Further research is ongoing on self-hypnosis delivery and implementation into wider populations of women using clear definition and control groups.",2020,There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time.,"['menopausal women', 'menopausal women with sleep and hot flashes', 'Menopausal Women', '90 women were presented']","['Complementary and Integrative Health (NCCIH', 'Hypnosis', 'Hypnosis Intervention', 'Self-Hypnosis']","['perception of poor sleep quality', 'poor physical, psychological, cognition, and social outcomes', 'poor sleep quality']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",90.0,0.0167533,There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time.,"[{'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Otte', 'Affiliation': 'School of Nursing, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Carpenter', 'Affiliation': 'School of Nursing, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Lynae', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'Mind-Body Medicine Research Laboratory, Department of Psychology and Neuroscience, Baylor University, Waco, Texas.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Elkins', 'Affiliation': 'Mind-Body Medicine Research Laboratory, Department of Psychology and Neuroscience, Baylor University, Waco, Texas.'}]",Journal of women's health (2002),['10.1089/jwh.2020.8327']
383,32198423,Effects of exergames on heart rate variability of women with fibromyalgia: A randomized controlled trial.,"The objective of the present manuscript was to evaluate the effects of 24-weeks exergame intervention on the heart rate variability (HRV) of women with fibromyalgia. First, 56 women with fibromyalgia were assessed for eligibility. A total of 55 women fulfilled the inclusion criteria and participated in this single-blinded, randomized controlled trial. A 24-weeks of exergames were completed by the exercise group in the university facilities. It was focused on the mobility, postural control, upper and lower limbs coordination, aerobic fitness and strength. A total of 120 min per week, divided into two sessions of 60 min, was completed. A short-term 5 min record at rest was used to assess the HRV. Time (SDNN and RMSSD) and non-linear indexes (Higuchi´s Fractal Dimension, SD1, SD2, ln stress score, and SD1/SD2) of HRV were extracted. Fifty participants (achieving an 89.28% of adherence), recruited from the local fibromyalgia association completed the study. They were randomly divided into an exercise (age = 54.04[8.45]) and a control group (52.72[9.98]). Significant interaction (group*time) effects in SDNN, ln stress score, SD2, and SD1/SD2 ratio were found. The EG showed an increase of SDNN and a decreased ln stress score and SD2. The CG showed an increased ln stress score, SD1/SD2. In conclusion, 24-weeks of exergame intervention based on the tool VirtualEx-FM improved the autonomic control in patients with fibromyalgia. However, significant effects on Higuchi´s fractal dimension were not found. This is the first study using exergame as a therapy in women with fibromyalgia which has led to an improvement the autonomic balance in these patients.",2020,The EG showed an increase of SDNN and a decreased ln stress score and SD2.,"['55 women fulfilled the inclusion criteria and participated', 'women with fibromyalgia', 'Fifty participants (achieving an 89.28% of adherence), recruited from the local fibromyalgia association completed the study', '56 women with fibromyalgia', 'patients with fibromyalgia']",['24-weeks exergame intervention'],"['autonomic balance', 'mobility, postural control, upper and lower limbs coordination, aerobic fitness and strength', 'heart rate variability', 'ln stress score, SD1/SD2', 'Higuchi´s fractal dimension', 'Higuchi´s Fractal Dimension, SD1, SD2, ln stress score, and SD1/SD2) of HRV', 'Time (SDNN and RMSSD) and non-linear indexes', 'ln stress score and SD2', 'Significant interaction (group*time) effects in SDNN, ln stress score, SD2, and SD1/SD2 ratio', 'heart rate variability (HRV']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",56.0,0.048548,The EG showed an increase of SDNN and a decreased ln stress score and SD2.,"[{'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV). Faculty of Sport Science, University of Extremadura, Extremadura, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943, Fuenlabrada, Madrid, Spain. danicolladom@gmail.com.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Domínguez-Muñoz', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV). Faculty of Sport Science, University of Extremadura, Extremadura, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV). Faculty of Sport Science, University of Extremadura, Extremadura, Spain.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Fuentes-Garcia', 'Affiliation': 'Faculty of Sport Science, University of Extremadura, Extremadura, Spain.'}]",Scientific reports,['10.1038/s41598-020-61617-8']
384,31695350,Wearable Technology To Reduce Sedentary Behavior And CVD Risk In Older Adults: A Pilot Randomized Clinical Trial.,"Background


Physical exercise is associated with decreased cardiovascular disease (CVD) risk, but recent large-scale trials suggest that exercise alone is insufficient to reduce CVD events in high-risk older adults.
Purpose


This pilot randomized clinical trial aimed to collect critical data on feasibility, safety, and protocol integrity necessary to design a fully powered randomized controlled trial (RCT) and evaluate the impact of combining structured exercise with an intervention designed to enhance non-exercise physical activity (EX+NEPA) compared to EX alone.
Methods


Forty participants aged ≥60 years with moderate-to-high risk of coronary heart disease events were randomly assigned to either the EX+NEPA or EX groups and followed for 20 weeks. Both groups underwent a twice-weekly, 8-week center-based exercise intervention with aerobic and resistance exercises. EX+NEPA group also received a wearable activity tracking device along with behavioral monitoring and feedback throughout the study. Study outcomes were evaluated at 8 and 20 weeks.
Results


Data are presented as adjusted mean change of the differences over time with 95% confidence intervals at 20 weeks. Relative to EX, the change in steps/day at 20 weeks was 1994 (-40.27, 4028) higher for EX+NEPA. For sedentary time at close-out, the EX+NEPA group was -6.8 (-45.2, 31.6) min/day relative to EX. The between-group differences for systolic and diastolic blood pressure were -9.9 (-19.6, -0.3) and -1.8 (-6.9, 3.3) mmHg, respectively.
Conclusion


The addition of wearable technology intervention appeared to positively influence daily activity patterns and changes in blood pressure - potentially improving risk factors for CVD. A fully powered randomized trial is needed to ultimately test this hypothesis.",2019,The addition of wearable technology intervention appeared to positively influence daily activity patterns and changes in blood pressure - potentially improving risk factors for CVD.,"['Older Adults', 'high-risk older adults', 'Forty participants aged ≥60 years with moderate-to-high risk of coronary heart disease events']","['structured exercise with an intervention designed to enhance non-exercise physical activity (EX+NEPA', '8-week center-based exercise intervention with aerobic and resistance exercises', '\n\n\nPhysical exercise', 'Wearable Technology', 'EX+NEPA or EX', 'EX+NEPA', 'wearable activity tracking device']","['CVD events', 'blood pressure', 'And CVD Risk', 'systolic and diastolic blood pressure', 'Sedentary Behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4505348', 'cui_str': 'Wearable Electronic Devices'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}]",40.0,0.129679,The addition of wearable technology intervention appeared to positively influence daily activity patterns and changes in blood pressure - potentially improving risk factors for CVD.,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Roberts', 'Affiliation': 'Department of Medicine, Division of Gerontology/Geriatrics/Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Byron C', 'Initials': 'BC', 'LastName': 'Jaeger', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Liliana C', 'Initials': 'LC', 'LastName': 'Baptista', 'Affiliation': 'Department of Medicine, Division of Gerontology/Geriatrics/Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Harper', 'Affiliation': 'Department of Medicine, Division of Gerontology/Geriatrics/Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Gardner', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jackson', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health, the University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Bhanuprasad', 'Initials': 'B', 'LastName': 'Sandesara', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Buford', 'Affiliation': 'Department of Medicine, Division of Gerontology/Geriatrics/Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Clinical interventions in aging,['10.2147/CIA.S222655']
385,31815582,"Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of  ERCC1 : SWOG S1201.","PURPOSE


Platinum-based therapy is the standard of care in patients who have HER2-negative, advanced esophagogastric cancer (AEGC). Retrospective data suggest that intratumoral  ERCC1  levels may determine platinum sensitivity. A randomized, phase II study was performed in patients with AEGC to explore whether the efficacy of a platinum-based therapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus a non-platinum-containing regimen of irinotecan and docetaxel (IT) differed according to  ERCC1  levels.
PATIENTS AND METHODS


Overall, 202 untreated patients with HER2-negative AEGC and a Zubrod performance status of 0-1 were evaluated prospectively for mRNA expression of  ERCC1  level and then randomly assigned to FOLFOX or IT, stratified by the intratumoral statuses of  ERCC1  low (< 1.7) or high (≥ 1.7). Objectives were to assess progression-free survival (PFS) and overall survival (OS) in all patients treated with FOLFOX compared with IT, stratified by low and high  ERCC1  levels, and to assess for interactive effects between  ERCC1  expression and treatment arm.
RESULTS


Eighty-six percent of patients had  ERCC1  values < 1.7. Thus, evaluation of the  ERCC1 -high subgroup was limited. Grade ≥ 3 anemia, dehydration, diarrhea, and fatigue were greater in patients with IT. Occurrences of grade ≥ 3 neuropathy and decreased neutrophils were greater in patients with FOLFOX. In all patients, FOLFOX had a statistically superior median PFS compared with IT (5.7  v  2.9 months; hazard ratio, 0.68;  P  = .02). In patients with  ERCC1  levels < 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
CONCLUSION


The evaluation of  ERCC1  in patients with upper GI tumors was thwarted by an overwhelming predominance of low  ERCC1  mRNA expression. Nonetheless, distribution of treatment effects on PFS did not vary with expression. For all patients and for those with low  ERCC1  expression, FOLFOX was superior in efficacy to IT.",2020,"< 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
","['patients with AEGC', 'patients who have HER2-negative, advanced esophagogastric cancer (AEGC', 'patients with  ERCC1  levels', 'patients with upper GI tumors', 'Overall, 202 untreated patients with HER2-negative AEGC and a Zubrod performance status of 0-1 were evaluated prospectively for mRNA expression of  ERCC1  level and then randomly assigned to FOLFOX or IT, stratified by the intratumoral statuses of  ERCC1  low (< 1.7) or high (≥ 1.7']","['FOLFOX', 'Platinum-based therapy', 'platinum-based therapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus a non-platinum-containing regimen of irinotecan and docetaxel (IT']","['PFS and response rate', 'progression-free survival (PFS) and overall survival (OS', 'OS', '3 neuropathy and decreased neutrophils', 'Occurrences of grade ≥', 'Grade ≥ 3 anemia, dehydration, diarrhea, and fatigue', 'superior median PFS', 'Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1112160', 'cui_str': 'Gastrooesophageal cancer'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",202.0,0.0416042,"< 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
","[{'ForeName': 'Syma', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McDonough', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale University School of Medicine and Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Chaitali S', 'Initials': 'CS', 'LastName': 'Nangia', 'Affiliation': 'University of California Irvine, Orange, CA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Schneider', 'Affiliation': 'University of Pennsylvania, Newark, DE.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Dotan', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00925']
386,31418516,Predictors of response to insulin therapy in youth with poorly-controlled type 2 diabetes in the TODAY trial.,"OBJECTIVE


To understand the factors associated with glycemic control after starting insulin in youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with metformin alone, metformin + rosiglitazone or metformin + lifestyle in the TODAY study.
METHODS


Change in HbA1c after add-on insulin therapy and the factors predictive of glycemic response were evaluated. At 1-year postinsulin initiation, 253 youth had a mean of 3.9 ± 1.0 visits since the time of insulin initiation. Participants were divided into three groups according to glycemic control: consistent decrease in HbA1c by ≥0.5%, change <0.5%, or consistent increase in HbA1c ≥0.5%, at 75% or more of the visits.
RESULTS


Within 1-year postinsulin initiation, 33.2% of participants had a consistent HbA1c decrease of ≥0.5%, 46.2% changed HbA1c <0.5%, and 20.6% had an increase ≥0.5%. At randomization into TODAY and at time of insulin initiation, the three glycemia groups were similar in age, sex, race-ethnicity, pubertal stage, BMI z-score, diabetes duration, and insulin secretion indices. Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
CONCLUSIONS


Response to add-on insulin was highly variable among youth in TODAY. Greater insulin sensitivity and higher adiponectin concentrations at randomization were associated with improved glycemic control after initiation of insulin. Due to limited information on adherence to insulin injections, the roles of adherence to the prescribed insulin regimen or psychosocial factors are unknown.",2019,"Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
","['youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with', 'youth with poorly-controlled type 2 diabetes', '253 youth had a mean of 3.9\u2009±\u20091.0 visits since the time of insulin initiation']","['metformin alone, metformin\u2009+\u2009rosiglitazone or metformin\u2009+\u2009lifestyle', 'insulin therapy']","['insulin sensitivity', 'Greater insulin sensitivity and higher adiponectin concentrations']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",253.0,0.0741428,"Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
","[{'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Children's Nutrition Research Center, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, Maryland.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""UPMC, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Zeitler', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Gandica', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Nancy T', 'Initials': 'NT', 'LastName': 'Chang', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, Louisiana.""}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Sprague', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Macleish', 'Affiliation': 'Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.12906']
387,31610033,Effects of Oxytocin Administration on Cue-Induced Craving in Co-occurring Alcohol Use Disorder and PTSD: A Within-Participant Randomized Clinical Trial.,"BACKGROUND


Individuals with alcohol use disorder (AUD) are much more likely to meet criteria for posttraumatic stress disorder (PTSD) than the general population. Compared to AUD alone, those with comorbid AUD-PTSD experience worse outcomes. Prior literature suggests that oxytocin, a hypothalamic neuropeptide, may be effective in the treatment of both AUD and PTSD when administered intranasally, although specific mechanisms remain elusive.
METHODS


Forty-seven male patients with comorbid AUD-PTSD were administered intranasal oxytocin in a randomized, double-blind, dose-ranging (20 IU, 40 IU, and matched placebo), within-participant design with study visits at least 1 week apart. A cue-induced craving paradigm was conducted using each participant's preferred alcoholic beverage versus a neutral water cue. Self-reported alcohol craving and heart rate (HR) were recorded and analyzed using linear mixed-effect models.
RESULTS


While alcohol cues significantly induced self-reported craving and increased HR compared to neutral water cues, neither dosage of oxytocin compared to placebo reduced self-reported cue-induced alcohol craving nor cue-induced changes in HR in patients with PTSD-AUD.
CONCLUSIONS


These preliminary findings suggest that oxytocin does not affect cue-induced craving. Our results contribute to an ever-growing field of research investigating the effects of intranasal oxytocin on the symptoms of substance use disorders and will help further refine methodology and streamline future inquiries in this area.",2019,"RESULTS


While alcohol cues significantly induced self-reported craving and increased heart rate compared to neutral water cues, neither dosage of oxytocin compared to placebo reduced self-reported cue-induced alcohol craving nor cue-induced changes in heart rate in patients with PTSD-AUD.
","['co-occurring alcohol use disorder and PTSD', 'Forty-seven male patients with comorbid AUD-PTSD were administered', 'Individuals with alcohol use disorder (AUD']","['placebo', 'intranasal oxytocin', 'oxytocin', 'alcoholic beverage versus a neutral water cue']","['cue-induced craving', 'Self-reported alcohol craving and heart rate', 'heart rate', 'self-reported craving and increased heart rate']","[{'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic Beverages'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}]",47.0,0.0600444,"RESULTS


While alcohol cues significantly induced self-reported craving and increased heart rate compared to neutral water cues, neither dosage of oxytocin compared to placebo reduced self-reported cue-induced alcohol craving nor cue-induced changes in heart rate in patients with PTSD-AUD.
","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'From the, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Nathan K', 'Initials': 'NK', 'LastName': 'Meinzer', 'Affiliation': 'Huron Consulting Group, Inc, Portland, Oregon.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Morrison', 'Affiliation': 'University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Wen', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Radanovich', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leung', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Niles', 'Affiliation': 'Youper, Inc., San Francisco, California.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'From the, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'From the, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, San Francisco, California.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14217']
388,32092717,Effects of Bisoprolol Transdermal Patches for Prevention of Perioperative Myocardial Injury in High-Risk Patients Undergoing Non-Cardiac Surgery　- Multicenter Randomized Controlled Study.,"BACKGROUND


The aim of this study was to evaluate the efficacy and safety of transdermal β-blocker patches, which offer stable blood concentration and easy availability during operation, for prevention of perioperative myocardial injury (PMI) in high-risk patients.Methods and Results:In this randomized controlled trial, patients aged >60 years with hypertension and high revised cardiac risk index (≥2) undergoing non-cardiac surgery were randomly assigned to a bisoprolol patch or control group. Primary efficacy outcome was incidence of PMI, defined as postoperative high-sensitivity cardiac troponin T (hs-cTnT) >0.014ng/mL and relative hs-cTnT change ≥20%. Secondary efficacy outcomes were number of cardiovascular events and 30-day mortality. From November 2014 to February 2019, 240 patients from 5 hospitals were enrolled in this study. The incidence of PMI was 35.7% in the bisoprolol patch group and 44.5% in the control group (P=0.18). Incidence of major adverse cardiac events including non-critical myocardial infarction, strokes, decompensated heart failure and tachyarrhythmia was similar between the 2 groups. Tachyarrhythmia tended to be higher in the control group. There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups.
CONCLUSIONS


Bisoprolol patches do not influence the incidence of PMI and cardiovascular events in high-risk patients undergoing non-cardiac surgery, but perioperative use of these patches is safe.",2020,"There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups.
","['high-risk patients undergoing non-cardiac surgery', 'High-Risk Patients Undergoing Non-Cardiac Surgery\u3000- Multicenter', 'high-risk patients', 'patients aged >60 years with hypertension and high revised cardiac risk index (≥2) undergoing non-cardiac surgery', 'From November 2014 to February 2019, 240 patients from 5 hospitals were enrolled in this study']","['bisoprolol patch or control group', 'Bisoprolol Transdermal Patches']","['efficacy and safety', 'incidence of PMI and cardiovascular events', 'safety outcomes including significant hypotension and bradycardia', 'Perioperative Myocardial Injury', 'number of cardiovascular events and 30-day mortality', 'Incidence of major adverse cardiac events including non-critical myocardial infarction, strokes, decompensated heart failure and tachyarrhythmia', 'incidence of PMI, defined as postoperative high-sensitivity cardiac troponin T (hs-cTnT', 'Tachyarrhythmia', 'incidence of PMI']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3164217', 'cui_str': 'Revised cardiac risk index (assessment scale)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}]",,0.316886,"There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups.
","[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ejiri', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Iwano', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Nishii', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Hikasa', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morita', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morimatsu', 'Affiliation': 'Department of Anesthesiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0871']
389,32162721,Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials.,"AIMS


In this exposure-response analysis, the dosing regimen for tildrakizumab, an antibody for treating moderate-to-severe chronic plaque psoriasis, was determined using data from 3 randomised controlled trials (P05495/NCT01225731: phase 2b, n = 355; reSURFACE 1/NCT01722331: phase 3, n = 772; reSURFACE 2/NCT01729754: phase 3, n = 1090).
METHODS


A maximum drug effect (E max  ) logistic-regression exposure-efficacy model was used to describe the week 12 Psoriasis Area and Severity Index (PASI) responses with average concentration of tildrakizumab during weeks 1-12 (C avg12  ) as exposure metric. The impact of covariates (e.g., body weight, region) was tested. Exposure-safety, longitudinal pharmacokinetic-pharmacodynamic and risk-benefit analyses were also conducted.
RESULTS


At week 12, E max  was estimated at 62.2, 37.9 and 14.6% of responders for PASI75/90/100, respectively. Exposure-response curves plateaued at exposures >5 μg mL -1  . Heavier subjects had a lower response rate to placebo as measured by PASI75/90/100 than lighter subjects. PASI100 placebo response was less in subjects with higher baseline PASI score and older age. Simulated week 12 PASI75 increased by ≤4% on increasing the dose from 100 to 200 mg every 12 weeks (Q12W). The pharmacokinetic-pharmacodynamic model adequately described the time course of PASI change after treatment in the entire population and in each subject. Risk-benefit profiles were favourable for the 100- and 200-mg doses in different weight subgroups.
CONCLUSIONS


Patients with moderate-to-severe psoriasis should receive 100-mg subcutaneous tildrakizumab Q12W. Patients with high body weight (>90 kg) may benefit from a higher dose (200-mg Q12W).",2020,Simulated week 12 PASI75 increased by ≤4% on increasing the dose from 100 to 200 mg every 12 weeks (Q12W).,"['chronic plaque psoriasis', 'Patients with moderate-to-severe psoriasis', 'subjects with higher baseline PASI score and older age']","['tildrakizumab', '100-mg subcutaneous tildrakizumab Q12W', 'PASI100 placebo', 'placebo']","['12 Psoriasis Area and Severity Index (PASI) responses', 'response rate', 'time course of PASI change']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0682585,Simulated week 12 PASI75 increased by ≤4% on increasing the dose from 100 to 200 mg every 12 weeks (Q12W).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kerbusch', 'Affiliation': ''}, {'ForeName': 'Hanbin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Certara USA, Inc., Princeton, NJ, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Wada', 'Affiliation': 'Certara USA, Inc., Princeton, NJ, USA.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Jauslin', 'Affiliation': 'Certara USA, Inc., Princeton, NJ, USA.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Wenning', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14280']
390,32198409,Intrauterine G-CSF Administration in Recurrent Implantation Failure (RIF): An Rct.,"This study investigates the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group with normal endometrium. This study was designed as a prospective randomized controlled trial with the involvement of 157 RIF group pati; ents. The RIF group was formed on the basis of the RIF criteria: ""The failure to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years. The study sample included 82 patients in the G-CSF group who received G-CSF once a day on hCG. The procedure was performed by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30 mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL was infused into the endometrial cavity in the same way in 75 patients in the control group. The standard ICSI procedure was used for all patients, and fresh cycle embryos were transferred on the third or fifth day. No statistically significant difference was identified in clinical pregnancy rates, miscarriage rates and live birth rates between the G-CSF group and the control group (p = 0.112, p = 0.171, p = 0.644, respectively), and no difference was observed between the two groups regarding endometrial thickness (p = 0.965). The intervention of administration G-CSF into the uterine cavity in RIF patients with normal endometrium, did not alter the endometrial thickness, clinical pregnancy rates, or live birth rates.",2020,"No statistically significant difference was identified in clinical pregnancy rates, miscarriage rates and live birth rates between the G-CSF group and the control group (p = 0.112, p = 0.171, p = 0.644, respectively), and no difference was observed between the two groups regarding endometrial thickness (p = 0.965).","['82 patients in the G-CSF group who received', 'RIF patients with normal endometrium', 'recurrent implantation failure (RIF) group with normal endometrium', '157 RIF group pati; ents', 'Recurrent Implantation Failure (RIF']","['Leucostim®(Filgrastim', 'Normal saline of 1\u2009mL', 'administration G-CSF', 'Intrauterine G-CSF Administration', 'intrauterine G-CSF', 'G-CSF once a day on hCG', 'G-CSF']","['endometrial thickness, clinical pregnancy rate and live birth rate', 'endometrial thickness, clinical pregnancy rates, or live birth rates', 'endometrial thickness', 'clinical pregnancy rates, miscarriage rates and live birth rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1274038', 'cui_str': 'Ear, nose and throat surgery'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",82.0,0.0669227,"No statistically significant difference was identified in clinical pregnancy rates, miscarriage rates and live birth rates between the G-CSF group and the control group (p = 0.112, p = 0.171, p = 0.644, respectively), and no difference was observed between the two groups regarding endometrial thickness (p = 0.965).","[{'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kalem', 'Affiliation': 'Istinye University Liv Hospital Bahcesehir, Department of IVF, Istanbul, Turkey.'}, {'ForeName': 'Muberra', 'Initials': 'M', 'LastName': 'Namli Kalem', 'Affiliation': 'Bahcesehir University, Department of Obstetrics and Gynecology, Istanbul, Turkey. muberranamli@hotmail.com.'}, {'ForeName': 'Batuhan', 'Initials': 'B', 'LastName': 'Bakirarar', 'Affiliation': 'Ankara University, Department of Biostatistics, Ankara, Turkey.'}, {'ForeName': 'Erkin', 'Initials': 'E', 'LastName': 'Kent', 'Affiliation': 'Gürgan Clinic IVF and Women Health Center, Department of Embryology, Ankara, Turkey.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Makrigiannakis', 'Affiliation': 'Crete University, Department of Obstetrics and Gynecology, Crete, Greece.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Gurgan', 'Affiliation': 'Bahcesehir University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}]",Scientific reports,['10.1038/s41598-020-61955-7']
391,31825704,Outcome in Children With Standard-Risk B-Cell Acute Lymphoblastic Leukemia: Results of Children's Oncology Group Trial AALL0331.,"PURPOSE


Children's Oncology Group (COG) AALL0331 tested whether intensified postinduction therapy that improves survival in children with high-risk B-cell acute lymphoblastic leukemia (ALL) would also improve outcomes for those with standard-risk (SR) ALL.
PATIENTS AND METHODS


AALL0331 enrolled 5,377 patients between 2005 and 2010. All patients received a 3-drug induction with dexamethasone, vincristine, and pegaspargase (PEG) and were then classified as SR low, SR average, or SR high. Patients with SR-average disease were randomly assigned to receive either standard 4-week consolidation (SC) or 8-week intensified augmented Berlin-Frankfurt-Münster (BFM) consolidation (IC). Those with SR-high disease were nonrandomly assigned to the full COG-augmented BFM regimen, including 2 interim maintenance and delayed intensification phases.
RESULTS


The 6-year event-free survival (EFS) rate for all patients enrolled in AALL0331 was 88.96% ± 0.46%, and overall survival (OS) was 95.54% ± 0.31%. For patients with SR-average disease, the 6-year continuous complete remission (CCR) and OS rates for SC versus IC were 87.8% ± 1.3% versus 89.1% ± 1.2% ( P  = .52) and 95.8% ± 0.8% versus 95.2% ± 0.8% ( P  = 1.0), respectively. Those with SR-average disease with end-induction minimal residual disease (MRD) of 0.01% to < 0.1% had an inferior outcome compared with those with lower MRD and no improvement with IC (6-year CCR: SC, 77.5% ± 4.8%; IC, 77.1% ± 4.8%;  P  = .71). At 6 years, the CCR and OS rates among 635 nonrandomly treated patients with SR-high disease were 85.55% ± 1.49% and 92.97% ± 1.08%, respectively.
CONCLUSION


The 6-year OS rate for > 5,000 children with SR ALL enrolled in AALL0331 exceeded 95%. The addition of IC to treatment for patients with SR-average disease did not improve CCR or OS, even in patients with higher MRD, in whom it might have been predicted to provide more value. The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.",2020,"The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.","['Patients with SR-average disease', 'patients with SR-average disease', 'Children With Standard-Risk B-Cell Acute Lymphoblastic Leukemia', ""Children's Oncology Group (COG"", 'children with high-risk B-cell acute lymphoblastic leukemia (ALL', 'AALL0331 enrolled 5,377 patients between 2005 and 2010']","['standard 4-week consolidation (SC) or 8-week intensified augmented Berlin-Frankfurt-Münster (BFM) consolidation (IC', 'AALL0331', 'dexamethasone, vincristine, and pegaspargase (PEG']","['6-year continuous complete remission (CCR) and OS rates', 'overall survival (OS', 'EFS) rate', 'EFS and OS rates', 'CCR and OS rates', '6-year OS rate', 'survival', '6-year event-free survival ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292769', 'cui_str': 'c-ALL'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",5377.0,0.0346203,"The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.","[{'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Maloney', 'Affiliation': 'Department of Pediatrics, University of Colorado, Aurora, CO.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine, Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Leonard A', 'Initials': 'LA', 'LastName': 'Mattano', 'Affiliation': 'HARP Pharma Consulting, Mystic, CT.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Friedmann', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Buckley', 'Affiliation': 'Department of Pathology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Gastier-Foster', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, Wexner Medical Center, Ohio State University, Columbus, OH.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kadan-Lottick', 'Affiliation': 'Department of Pediatrics, Yale University, New Haven, CT.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Yousif H', 'Initials': 'YH', 'LastName': 'Matloub', 'Affiliation': ""Department of Pediatrics, Rainbow Babies and Children's Hospital, Cleveland, OH.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Marshall', 'Affiliation': 'Department of Radiation Oncology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Stork', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Perlmutter Cancer Center, New York University (NYU) Langone Medical Center, New York, NY.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, WA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Perlmutter Cancer Center, New York University (NYU) Langone Medical Center, New York, NY.'}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas (UT) Southwestern, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01086']
392,31370975,A randomized pilot trial of two parenting interventions for fathers in residential substance use disorder treatment.,"Residential substance misuse treatment programs for men typically do not integrate treatment for intimate partner violence (IPV) or parenting despite significant overlap between substance misuse, IPV and child maltreatment. A randomized trial compared two fatherhood focused interventions in 6-month residential substance misuse treatment programs. Fathers for Change (F4C) is an integrated intervention targeting IPV and child maltreatment. Dads 'n' Kids (DNK) is a psychoeducational intervention focused on child development and behavioral parenting skills. Sixty-two fathers were randomly assigned to F4C or DNK. They received 12 weeks of individual treatment while in the residential facility and were offered 4 aftercare sessions following discharge. They were assessed prior to treatment, at the time of residential discharge, following completion of the intervention booster sessions, and 3 months following intervention. Overall, both groups showed significant reductions in affect dysregulation, anger, and IPV. F4C fathers showed significantly greater decreases in affect dysregulation problems. There were no significant differences between groups on IPV but men who received F4C may have been less likely to use substances after leaving residential treatment. Integration of fatherhood focused interventions were possible and welcomed by residents at the facilities. F4C showed some benefit over DNK in terms of affect dysregulation symptoms and substance use relapse.",2019,There were no significant differences between groups on IPV but men who received F4C may have been less likely to use substances after leaving residential treatment.,"[""Dads 'n' Kids (DNK"", 'Sixty-two fathers', 'fathers in residential substance use disorder treatment']","['parenting interventions', 'F4C or DNK', 'F4C']","['affect dysregulation, anger, and IPV']","[{'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]",,0.0485155,There were no significant differences between groups on IPV but men who received F4C may have been less likely to use substances after leaving residential treatment.,"[{'ForeName': 'Carla Smith', 'Initials': 'CS', 'LastName': 'Stover', 'Affiliation': 'Yale University School of Medicine, Child Study Center, New Haven, CT, USA; University of South Florida, Department of Mental Health Law and Policy, Tampa, FL, USA. Electronic address: carla.stover@yale.edu.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'McMahon', 'Affiliation': 'Yale University School of Medicine, Department of Psychiatry, New Haven, CT, USA; Yale University School of Medicine, Child Study Center, New Haven, CT, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'University of South Florida, Department of Mental Health Law and Policy, Tampa, FL, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.003']
393,32083686,Effect of Physician Gender and Race on Simulated Patients' Ratings and Confidence in Their Physicians: A Randomized Trial.,"Importance


Women and black physicians encounter workplace challenges because of their gender and race. It is unclear whether these individuals are assessed with lower patient satisfaction or confidence ratings compared with white male physicians.
Objective


To examine whether physician gender and race affect participant ratings in scenarios in which physician competence is challenged.
Design, Setting, and Participants


This randomized trial enrolled a geographically diverse sample of 3592 online respondents in the United States who were recruited from 2 crowdsourcing platforms: Amazon Mechanical Turk (n = 1741) and Lucid (n = 1851). A 2 × 2 factorial design for the gender and race of simulated physicians was conducted between March 9 and July 25, 2018. Participants were excluded before intervention if they were younger than 18 years, were pregnant, or had a history of cancer or abdominal surgical procedures.
Interventions


A clinical vignette was presented to the participant with a picture of the emergency department physician. Participants were randomly assigned to physicians with different gender and race, with 823 assigned to black women, 791 to black men, 828 to white women, and 835 to white men. A contradictory diagnosis from an online symptom checker introduced doubt about the clinical diagnosis.
Main Outcomes and Measures


A composite outcome (range, 0-100, with 0 representing low patient confidence and satisfaction and 100 representing the maximum on the composite scale) measured participant (1) confidence in the physician, (2) satisfaction with care, (3) likelihood to recommend the physician, (4) trust in the physician's diagnosis, and (5) likelihood to request additional tests.
Results


Among 3277 adult participants, complete data were available for 3215 (median age, 49 years [range, 18-89 years]; 1667 [52%] female; 2433 [76%] white). No significant differences were observed in participant satisfaction and physician confidence for the white male physician control physicians (mean composite score, 66.13 [95% CI, 64.76-67.51]) compared with white female (mean composite score, 66.50 [95% CI, 65.19-67.82]), black female (mean composite score, 67.36 [95% CI, 66.03-68.69]), and black male (mean composite score, 66.96 [95% CI, 65.55-68.36]) physicians. Machine learning with bayesian additive regression trees revealed no evidence of treatment effect heterogeneity as a function of participants' race, gender, racial prejudice, or sexism.
Conclusions and Relevance


No significant differences were observed for simulated patients' evaluations of female or black physicians, suggesting that bias in favor of white male physicians is negligible in survey-based measures of patient satisfaction.
Trial Registration


ClinicalTrials.gov Identifier: NCT04190901.",2020,"Machine learning with bayesian additive regression trees revealed no evidence of treatment effect heterogeneity as a function of participants' race, gender, racial prejudice, or sexism.
","['3277 adult participants, complete data were available for 3215 (median age, 49 years [range, 18-89 years]; 1667 [52%] female; 2433 [76%] white', 'Participants were excluded before intervention if they were younger than 18 years, were pregnant, or had a history of cancer or abdominal surgical procedures', 'geographically diverse sample of 3592 online respondents in the United States who were recruited from 2 crowdsourcing platforms: Amazon Mechanical Turk (n\u2009=\u20091741) and Lucid (n\u2009=\u20091851', 'Participants were randomly assigned to physicians with different gender and race, with 823 assigned to black women, 791 to black men, 828 to white women, and 835 to white men']",[],"['participant satisfaction and physician confidence', ""composite scale) measured participant (1) confidence in the physician, (2) satisfaction with care, (3) likelihood to recommend the physician, (4) trust in the physician's diagnosis, and (5) likelihood to request additional tests""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4708909', 'cui_str': '1667 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0455471', 'cui_str': 'H/O: malignant neoplasm'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C3494387', 'cui_str': 'Crowdsource'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0556994', 'cui_str': 'Lucid (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",3277.0,0.157813,"Machine learning with bayesian additive regression trees revealed no evidence of treatment effect heterogeneity as a function of participants' race, gender, racial prejudice, or sexism.
","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Solnick', 'Affiliation': 'National Clinical Scholars Program, Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Peyton', 'Affiliation': 'Yale Law School, New Haven, Connecticut.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Kraft-Todd', 'Affiliation': 'Department of Psychology, Boston College, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Basmah', 'Initials': 'B', 'LastName': 'Safdar', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.20511']
394,32217112,Radiofrequency ablation for low-grade dysplasia in Barrett's esophagus: long-term outcome of a randomized trial.,"BACKGROUND AND AIMS


A prior randomized study (Surveillance versus Radiofrequency Ablation study [SURF study]) demonstrated that radiofrequency ablation (RFA) of Barrett's esophagus (BE) with confirmed low-grade dysplasia (LGD) significantly reduces the risk of esophageal adenocarcinoma. Our aim was to report the long-term outcomes of this study.
METHODS


The SURF study randomized BE patients with confirmed LGD to RFA or surveillance. For this retrospective cohort study, all endoscopic and histologic data acquired at the end of the SURF study in May 2013 until December 2017 were collected. The primary outcome was rate of progression to high-grade dysplasia (HGD)/cancer. All 136 patients randomized to RFA (n = 68) or surveillance (n = 68) in the SURF study were included. After closure of the SURF study, 15 surveillance patients underwent RFA based on patient preference and study outcomes.
RESULTS


With 40 additional months (interquartile range, 12-51), the total median follow-up from randomization to last endoscopy was 73 months (interquartile range, 46-85). HGD/cancer was diagnosed in 1 patient in the RFA group (1.5%) and in 23 in the surveillance group (33.8%) (P = .000), resulting in an absolute risk reduction of 32.4% (95% confidence interval [CI], 22.4%-44.2%) with a number needed to treat of 3.1 (95% CI, 2.3-4.5). Seventy-five of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia. BE recurred in 7 of 75 patients (9%; 95% CI, 4.6%-18.0%), mostly minute islands or tongues, and LGD in 3 of 75 (4%; 95% CI, 1.4%-11.1%).
CONCLUSIONS


RFA of BE with confirmed LGD significantly reduces the risk of malignant progression, with sustained clearance of BE in 91% and LGD in 96% of patients, after a median follow-up of 73 months. (Clinical trial registration number: NTR1198.).",2020,"Seventy-five out of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia.","['all endoscopic and histological data acquired after end of the SURF study in May 2013 until December 2017 were collected', ""low-grade dysplasia in Barrett's esophagus"", '15 surveillance patients underwent', 'All 136 patients randomized to RFA (n=68) or surveillance (n=68) in the SURF study were included']","['Radiofrequency ablation', 'RFA', 'radiofrequency ablation (RFA']","['complete clearance of BE and dysplasia', 'rate of progression to HGD/cancer', 'HGD/cancer', 'BE', 'risk of malignant progression', 'absolute risk reduction']","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0336932', 'cui_str': 'Surfing'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0004763', 'cui_str': 'Barrett Metaplasia'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",15.0,0.172758,"Seventy-five out of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia.","[{'ForeName': 'Roos E', 'Initials': 'RE', 'LastName': 'Pouw', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Klaver', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'K Nadine', 'Initials': 'KN', 'LastName': 'Phoa', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Frederike G', 'Initials': 'FG', 'LastName': 'van Vilsteren', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bas L', 'Initials': 'BL', 'LastName': 'Weusten', 'Affiliation': 'Department of Gastroenterology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Raf', 'Initials': 'R', 'LastName': 'Bisschops', 'Affiliation': 'Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Schoon', 'Affiliation': 'Department of Gastroenterology, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pech', 'Affiliation': 'Department of Gastroenterology, Helios dr. Horst Schmidt Clinics Wiesbaden, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Manner', 'Affiliation': 'Department of Gastroenterology, Frankfurt Hoechst Hospital, Frankfurt, Germany.'}, {'ForeName': 'Krish', 'Initials': 'K', 'LastName': 'Ragunath', 'Affiliation': 'Department of Gastroenterology, Queens Medical Center, Nottingham, UK.'}, {'ForeName': 'Jacobo Ortiz', 'Initials': 'JO', 'LastName': 'Fernández-Sordo', 'Affiliation': 'Department of Gastroenterology, Queens Medical Center, Nottingham, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Fullarton', 'Affiliation': 'Department of Surgical Gastroenterology, Glasgow Royal Infirmary, Glasgow, Scotland.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Di Pietro', 'Affiliation': 'Medical Research Council, Cancer Unit, Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Wladyslaw', 'Initials': 'W', 'LastName': 'Januszewicz', 'Affiliation': 'Medical Research Council, Cancer Unit, Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': ""O'Toole"", 'Affiliation': ""Department of Clinical Medicine and Gastroenterology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Jacques J', 'Initials': 'JJ', 'LastName': 'Bergman', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.03.3756']
395,32033793,Mortality and Neurodevelopmental Outcomes in the Heart Rate Characteristics Monitoring Randomized Controlled Trial.,"OBJECTIVE


To test whether the composite outcome of death or neurodevelopmental impairment (NDI) at 18-22 months corrected age for infants ≤1000 g at birth is decreased by continuous monitoring of heart rate characteristics during neonatal intensive care.
STUDY DESIGN


We studied a subset of participants enrolled in a multicenter randomized trial of heart rate characteristics monitoring. Survivors were evaluated at 18-22 months corrected age with a standardized neurologic examination and the Bayley Scales of Infant Development-III (BSID-III). NDI was defined as Gross Motor Function Classification System of >2 (moderate or severe cerebral palsy), BSID-III language or cognitive scores of <70, severe bilateral hearing impairment, and/or bilateral blindness.
RESULTS


The composite outcome, death or NDI, was obtained for 628 of 884 study infants (72%). The prevalence of this outcome was 44.4% (136/306) among controls (infants randomized to heart rate characteristics monitored but not displayed) and 38.9% (125/322) among infants randomized to heart rate characteristics monitoring displayed (relative risk, 0.87; 95% CI, 0.73-1.05; P = .17). Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028). The composite outcomes of death or severe CP and death or mildly low Bayley cognitive score occurred less frequently in the displayed group (P < .05).
CONCLUSIONS


We found no difference in the composite outcome of death or NDI for extremely preterm infants whose heart rate characteristics were and were not displayed during neonatal intensive care. Two outcomes that included mortality or a specific NDI were less frequent in the displayed group.",2020,"Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028).",['death or neurodevelopmental impairment (NDI) at 18-22\xa0months corrected age for infants ≤1000'],[],"['mortality or a specific NDI', 'Mortality and Neurodevelopmental Outcomes', 'death or NDI', 'death or severe CP and death or mildly low Bayley cognitive score', 'standardized neurologic examination and the Bayley Scales of Infant Development-III', 'Gross Motor Function Classification System of >2 (moderate or severe cerebral palsy), BSID-III language or cognitive scores of <70, severe bilateral hearing impairment, and/or bilateral blindness', 'Mortality', 'composite outcome of death or NDI']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1879328', 'cui_str': 'Blindness, Complete'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",884.0,0.263847,"Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Oregon Health and Science University, Portland, OR. Electronic address: schelonk@ohsu.edu.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Bauer', 'Affiliation': 'Department of Pediatrics, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Peralta-Carcelen', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Helderman', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Christina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Moorman', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kattwinkel', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.066']
396,32037149,Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams.,"OBJECTIVES


To determine the effect of bovine lactoferrin on prevention of late-onset sepsis (LOS) and neurodevelopment delay.
STUDY DESIGN


Randomized, double-blind, controlled trial in neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing bovine lactoferrin 200 mg/kg/day with placebo administered for 8 weeks. The primary outcome was the first episode of culture-proven LOS or sepsis-associated death. Neurodevelopment delay was assessed by the Mullen Scales at 24 months corrected age.
RESULTS


Of the 414 infants enrolled, 209 received bovine lactoferrin and 205 received placebo. LOS or sepsis-associated death occurred in 22 infants (10.5%) in the bovine lactoferrin group vs 30 (14.6%) in the placebo group; there was no difference after adjusting for hospital and birth weight; hazard ratio 0.73 (95% CI, 0.42-1.26). For infants with birth weights of <1500 g the hazard ratio was 0.69 (95% CI, 0.39-1.25). The mean age-adjusted normalized Mullen composite score at 24 months was 83.3 ± 13.6 in the bovine lactoferrin group vs 82.6 ± 13.1 in the placebo group. Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
CONCLUSIONS


Supplementation with bovine lactoferrin did not decrease the incidence of sepsis in infants with birth weights of <2000 g. Growth and neurodevelopment outcomes at 24 months of age were similar. Neonatal bovine lactoferrin supplementation had no adverse effects.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01525316.",2020,"Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
","['414 infants enrolled', 'Infants Weighing Less', 'neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing']","['Bovine Lactoferrin', 'bovine lactoferrin', 'Neonatal bovine lactoferrin supplementation', 'placebo', 'bovine lactoferrin 200\xa0mg/kg/day with placebo']","['first episode of culture-proven LOS or sepsis-associated death', 'Sepsis\xa0and Neurodevelopment Impairment', 'mean age-adjusted normalized Mullen composite score', 'LOS or sepsis-associated death', 'prevention of late-onset sepsis (LOS) and neurodevelopment delay', 'Growth outcomes and rehospitalization rates', 'bronchiolitis', 'Neurodevelopment delay', 'incidence of sepsis']","[{'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C1440867', 'cui_str': 'lactoferrin, bovine'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",414.0,0.749494,"Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
","[{'ForeName': 'Theresa J', 'Initials': 'TJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Instituto de Medicina Tropical ""Alexander von Humboldt"", Universidad Peruana Cayetano Heredia, Lima, Peru; Center for Infectious Diseases, School of Public Health, University of Texas Health Science Center at Houston, Houston, TX. Electronic address: Theresa.Ochoa@upch.pe.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Zegarra', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Sicilia', 'Initials': 'S', 'LastName': 'Bellomo', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Cesar P', 'Initials': 'CP', 'LastName': 'Carcamo', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cam', 'Affiliation': 'Department of Pediatrics, Hospital Nacional Alberto Sabogal, Lima, Peru.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Castañeda', 'Affiliation': 'Department of Pediatrics, Hospital Nacional Guillermo Almenara, Lima, Peru.'}, {'ForeName': 'Aasith', 'Initials': 'A', 'LastName': 'Villavicencio', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gonzales', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Rueda', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Christie G', 'Initials': 'CG', 'LastName': 'Turin', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Alonso', 'Initials': 'A', 'LastName': 'Zea-Vera', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Guillen', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Department of Mathematics, School of Science and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ewing-Cobbs', 'Affiliation': ""Department of Pediatrics and Children's Learning Institute, School of Medicine, University of Texas Health Science Center at Houston, Houston, TX.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.038']
397,32041720,Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa.,"AIMS


To report the safety and efficacy of intravitreal aflibercept (Eylea) (ivA) for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) at 12 months via mean central macular thickness (CMT) and reported adverse events.
METHODS


A prospective, exploratory, phase II, non-randomised, single-centre, open-label, 1-arm clinical trial involving 30 eyes of 30 patients. Serial ivA was given via loading dose (three injections) followed by treat and extend protocol over 12 months.
RESULTS


Twenty-nine out of 30 (96.7%) patients completed 12 months of follow-up. A total of four to 11 injections per patient were given over the 12 month study. No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall. Eleven out of 29 (37.9%) participants were considered as 'responders', demonstrating at least an 11% reduction of CMT at 12 months on spectral domain optical coherence tomography compared with baseline. A reduction of CMT by mean (SD) 28.1% (12.9 %) was observed in responders at 12 months, however, no statistically significant corresponding improvement in best corrected VA was seen. Baseline characteristics were similar between responder and non-responder groups. No clinically significant adverse events were deemed secondary to ivA.
CONCLUSION


This first prospective exploratory study demonstrates both the safety and acceptability of serial ivA in patients with RP-CMO, effective at reducing CMT in 37.9% of patients. All patients demonstrating anatomical response did so after their first injection. Longer duration of CMO did not negatively affect response to anti-VEGF. Further study in a larger cohort of patients with shorter CMO duration would be valuable to better establish the utility of VEGF blockade in RP-CMO.
TRIAL REGISTRATION NUMBERS


EudraCT (2015-003723-65); ClinicalTrials.gov (NCT02661711).",2020,No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall.,"['cystoid macular oedema associated with retinitis pigmentosa', '30 eyes of 30 patients', 'patients with RP-CMO, effective at reducing CMT in 37.9% of patients', 'retinitis pigmentosa-associated cystoid macular oedema (RP-CMO']","['aflibercept', 'intravitreal aflibercept (Eylea) (ivA']","['safety and efficacy', 'Longer duration of CMO', 'CMT or visual acuity (VA) improvement']","[{'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",30.0,0.0970614,No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall.,"[{'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Strong', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'Primary Care and Public Health Sciences, Kings College London, London, UK.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Georgiou', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Simona Degli', 'Initials': 'SD', 'LastName': 'Esposti', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Kalitzeos', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webster', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Michaelides', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK michel.michaelides@ucl.ac.uk.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315152']
398,32217876,Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation in Difficult Weaning: A Randomized Trial.,"BACKGROUND


Difficult weaning frequently develops in ventilated patients and is associated with poor outcome. In neurally adjusted ventilatory assist, the ventilator is controlled by diaphragm electrical activity, which has been shown to improve patient-ventilator interaction. The objective of this study was to compare neurally adjusted ventilatory assist and pressure support ventilation in patients difficult to wean from mechanical ventilation.
METHODS


In this nonblinded randomized clinical trial, difficult-to-wean patients (n = 99) were randomly assigned to neurally adjusted ventilatory assist or pressure support ventilation mode. The primary outcome was the duration of weaning. Secondary outcomes included the proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality. Weaning duration was calculated as 28 days for patients under mechanical ventilation at day 28 or deceased before day 28 without successful weaning.
RESULTS


Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52; 3.0 [1.2 to 8.0] days vs. 7.4 [2.0 to 28.0], mean difference: -5.5 [95% CI, -9.2 to -1.4], P = 0.039). Post hoc sensitivity analysis also showed that the neurally adjusted ventilatory assist group had shorter weaning duration (hazard ratio, 0.58; 95% CI, 0.34 to 0.98). The proportion of patients with successful weaning from invasive mechanical ventilation was higher in neurally adjusted ventilatory assist (33 of 47 patients, 70%) compared with pressure support ventilation (25 of 52 patients, 48%; respiratory rate for neurally adjusted ventilatory assist: 1.46 [95% CI, 1.04 to 2.05], P = 0.026). The number of ventilator-free days at days 14 and 28 was statistically significantly higher in neurally adjusted ventilatory assist compared with pressure support ventilation. Neurally adjusted ventilatory assist improved patient ventilator interaction. Mortality and length of stay in the intensive care unit and in the hospital were similar among groups.
CONCLUSIONS


In patients difficult to wean, neurally adjusted ventilatory assist decreased the duration of weaning and increased ventilator-free days.",2020,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"['patients difficult to wean from mechanical ventilation', 'wean patients (n = 99', 'ventilated patients', 'Difficult Weaning']","['neurally adjusted ventilatory assist and pressure support ventilation', 'Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation', 'neurally adjusted ventilatory assist or pressure support ventilation mode', 'pressure support ventilation']","['shorter weaning duration', 'proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality', 'proportion of patients with successful weaning from invasive mechanical ventilation', 'Mortality and length of stay', 'patient ventilator interaction', 'respiratory rate', 'number of ventilator-free days', 'Weaning duration', 'duration of weaning', 'pressure support ventilation', 'duration of weaning and increased ventilator-free days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",99.0,0.15027,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'From the Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, Jiangsu, China (L.L., X.X., Q.S., Y. Yu., F.X., J.X., Y. Yang, H.Q.) the Department of Intensive Care, Amsterdam University Medical Center, Amsterdam, The Netherlands (L.H.).'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Feiping', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Heunks', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003207']
399,31158346,"Assessment of Valeriana officinalis l. (Valerian) for Conscious Sedation of Patients During the Extraction of Impacted Mandibular Third Molars: A Randomized, Split-Mouth, Double-Blind, Crossover Study.","PURPOSE


The objective of the present study was to evaluate the effectiveness of an herbal drug (valerian) to control anxiety during mandibular third molar extraction compared with a reference benzodiazepine drug commonly used in dental procedures (midazolam).
MATERIALS AND METHODS


Twenty anxious patients with an indication for bilateral extraction of mandibular third molars were selected. The patients received capsules containing valerian 100 mg or midazolam 15 mg orally 60 minutes before the procedures in a randomized, split-mouth, crossover design. Changes in the physiological parameters (eg, oxygen saturation, heart rate, blood pressure, respiratory rate) were assessed at specific times during surgery, and the patients completed a questionnaire postoperatively. The data were analyzed using the Wilcoxon and paired t tests, with a significance level of 5%.
RESULTS


No statistically significant differences in oxygen saturation were observed, regardless of the drug used. However, the other physiological parameters were significantly lower when the patients had taken midazolam compared with valerian. Somnolence was the most common side effect reported with both drugs.
CONCLUSIONS


Although midazolam was more effective in reducing the physiological parameters studied, valerian seemed to provide the comfort and relaxation required, with no sedation and less somnolence than midazolam, during third molar extraction. Further studies are necessary before valerian can be clinically recommended.",2019,"No statistically significant differences in oxygen saturation were observed, regardless of the drug used.","['Twenty anxious patients with an indication for bilateral extraction of mandibular third molars were selected', 'Conscious Sedation of Patients']","['capsules containing valerian 100\xa0mg or midazolam', 'midazolam', 'benzodiazepine drug commonly used in dental procedures (midazolam', 'Valeriana officinalis l. (Valerian', 'herbal drug (valerian']","['somnolence', 'physiological parameters (eg, oxygen saturation, heart rate, blood pressure, respiratory rate', 'oxygen saturation', 'Somnolence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042281', 'cui_str': 'Valeriana'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",20.0,0.125999,"No statistically significant differences in oxygen saturation were observed, regardless of the drug used.","[{'ForeName': 'Gustavo Jacobucci', 'Initials': 'GJ', 'LastName': 'Farah', 'Affiliation': 'Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, State University of Maringá, Maringá, Brazil.'}, {'ForeName': 'Gustavo Zanna', 'Initials': 'GZ', 'LastName': 'Ferreira', 'Affiliation': 'Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, UniCesumar, Maringá, Brazil; and PhD Student, Bauru School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: gustavozanna@hotmail.com.'}, {'ForeName': 'Carolina Ferrairo', 'Initials': 'CF', 'LastName': 'Danieletto-Zanna', 'Affiliation': 'Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, UniCesumar, Maringá, Brazil; and PhD Student, Bauru School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Caroline Resquetti', 'Initials': 'CR', 'LastName': 'Luppi', 'Affiliation': 'Specialist, Private Practitioner, Maringá, Paraná, Brazil.'}, {'ForeName': 'Willian Pecin', 'Initials': 'WP', 'LastName': 'Jacomacci', 'Affiliation': 'Specialist, Private Practitioner Maringá, Paraná, Brazil.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.05.003']
400,31319053,"Comparison of Three Anxiety Management Protocols for Extraction of Third Molars With the Use of Midazolam, Diazepam, and Nitrous Oxide: A Randomized Clinical Trial.","PURPOSE


The objective of the present study was to compare 3 sedation protocols using diazepam, midazolam, and nitrous oxide.
PATIENTS AND METHODS


A total of 120 patients with an indication for extraction of third molars were selected. All 120 patients had had moderate to severe levels of anxiety according to the Corah Dental Anxiety Scale. The patients were randomly divided into 3 groups. The patients' vital signs were measured, and the results analyzed by descriptive statistical analysis and statistical tests of comparison.
RESULTS


No statistically significant differences were found in the patients' heart rate. However, the differences in the systolic and diastolic blood pressure were statistically significant after 15 minutes of nitrous oxide sedation. The oximetry data showed no differences among the 3 sedation protocols. We also found no statistically significant differences in the retrograde amnesia test. The differences in anxiety from preoperatively to postoperatively were statistically significant for all techniques, demonstrating their effectiveness in anxiety control.
CONCLUSIONS


All 3 preoperative sedation techniques for anxious patients undergoing extraction of third molars used in the present study were effective in controlling the anxiety, with little effect on the patients' vital signs and retrograde amnesia.",2019,"The differences in anxiety from preoperatively to postoperatively were statistically significant for all techniques, demonstrating their effectiveness in anxiety control.
","['anxious patients undergoing extraction of third molars', 'All 120 patients had had moderate to severe levels of anxiety according to the Corah Dental Anxiety Scale', '120 patients with an indication for extraction of third molars were selected']","['diazepam, midazolam, and nitrous oxide', 'Midazolam, Diazepam, and Nitrous Oxide']","['systolic and diastolic blood pressure', 'retrograde amnesia test', 'anxiety', ""patients' heart rate""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0222045'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0002624', 'cui_str': 'Retrograde amnesia (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",120.0,0.0188975,"The differences in anxiety from preoperatively to postoperatively were statistically significant for all techniques, demonstrating their effectiveness in anxiety control.
","[{'ForeName': 'Michelle Bianchi', 'Initials': 'MB', 'LastName': 'de Moares', 'Affiliation': 'Assistant Professor, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, College of Dentistry, State University of São Paulo, São José dos Campos, Brazil.'}, {'ForeName': 'Winnie Souza', 'Initials': 'WS', 'LastName': 'Barbier', 'Affiliation': 'DDS Student, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, College of Dentistry, State University of São Paulo, São José dos Campos, Brazil.'}, {'ForeName': 'Fernando Vagner', 'Initials': 'FV', 'LastName': 'Raldi', 'Affiliation': 'Assistant Professor, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, College of Dentistry, State University of São Paulo, São José dos Campos, Brazil.'}, {'ForeName': 'Rodrigo Dias', 'Initials': 'RD', 'LastName': 'Nascimento', 'Affiliation': 'Assistant Professor, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, College of Dentistry, State University of São Paulo, São José dos Campos, Brazil.'}, {'ForeName': 'Lúcio Murilo', 'Initials': 'LM', 'LastName': 'Dos Santos', 'Affiliation': 'Assistant Professor, Department of Biosciences and Oral Diagnosis, College of Dentistry, State University of São Paulo, São José dos Campos, Brazil.'}, {'ForeName': 'Fábio Ricardo', 'Initials': 'FR', 'LastName': 'Loureiro Sato', 'Affiliation': 'Assistant Professor, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, College of Dentistry, State University of São Paulo, São José dos Campos, Brazil. Electronic address: fabio.sato@ict.unesp.br.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.06.001']
401,31464548,Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report.,"Background:  The purpose of this prospective, investigator-initiated feasibility study is to evaluate the efficacy and safety of nonablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI).  Materials and Methods:  Subjects meeting all the inclusion and exclusion criteria were enrolled and divided into two groups. Subjects in Group 1 received a single SUI treatment, and subjects in Group 2 received two SUI treatments ∼6 weeks apart. Follow-up visits are planned for 1, 4, 6, and 12 months post-treatment. At each study visit, subjects are asked to perform a 1-hour pad-weight test (PWT) and to complete the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) questionnaires. In addition, subjects completed 7-day bladder voiding diary and safety assessments.  Results:  Preliminary data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective 1-hour PWT, with a >50% reduction in pad weight for 68.8% of the Group 1 subjects and 69.2% of the Group 2 subjects at 6 months. Initial review of the bladder voiding diaries suggests that subjects are having fewer urine leakage episodes per day. In addition to efficacy, the CMRF Viveve System was well tolerated and safe.  Conclusions:  The endpoints evaluated indicate an improvement in SUI symptoms and quality of life. The sustained benefit of the CMRF vaginal treatment at 6 months suggests potential use as a nonsurgical approach to treat SUI.",2020,"Preliminary data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective 1-hour PWT, with a >50% reduction in pad weight for 68.8% of the Group 1 subjects and 69.2% of the Group 2 subjects at 6 months.","['Subjects meeting all the inclusion and exclusion criteria were enrolled and divided into two groups', 'stress urinary incontinence (SUI', 'Female Stress Urinary Incontinence']","['single SUI treatment', 'Viveve System', 'nonablative, cryogen-cooled, monopolar radiofrequency (CMRF']","['tolerated and safe', '7-day bladder voiding diary and safety assessments', 'Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) questionnaires', 'pad weight', 'SUI symptoms and quality of life']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.0253293,"Preliminary data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective 1-hour PWT, with a >50% reduction in pad weight for 68.8% of the Group 1 subjects and 69.2% of the Group 2 subjects at 6 months.","[{'ForeName': 'Bruce B', 'Initials': 'BB', 'LastName': 'Allan', 'Affiliation': 'Allan Centre, Calgary, Canada.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Viveve, Inc., Englewood, Colorado.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Husarek', 'Affiliation': 'Viveve, Inc., Englewood, Colorado.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7567']
402,30939090,Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.,"PURPOSE


Alliance/CALGB 50303 (NCT00118209), an intergroup, phase III study, compared dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as frontline therapy for diffuse large B-cell lymphoma.
PATIENTS AND METHODS


Patients received six cycles of DA-EPOCH-R or R-CHOP. The primary objective was progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety.
RESULTS


Between 2005 and 2013, 524 patients were registered; 491 eligible patients were included in the final analysis. Most patients (74%) had stage III or IV disease; International Prognostic Index (IPI) risk groups included 26% IPI 0 to 1, 37% IPI 2, 25% IPI 3, and 12% IPI 4 to 5. At a median follow-up of 5 years, PFS was not statistically different between the arms (hazard ratio, 0.93; 95% CI, 0.68 to 1.27;  P  = .65), with a 2-year PFS rate of 78.9% (95% CI, 73.8% to 84.2%) for DA-EPOCH-R and 75.5% (95% CI, 70.2% to 81.1%) for R-CHOP. OS was not different (hazard ratio, 1.09; 95% CI, 0.75 to 1.59;  P  = .64), with a 2-year OS rate of 86.5% (95% CI, 82.3% to 91%) for DA-EPOCH-R and 85.7% (95% CI, 81.4% to 90.2%) for R-CHOP. Grade 3 and 4 adverse events were more common ( P  < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9%  v  10.7%, respectively), febrile neutropenia (35.0%  v  17.7%, respectively), mucositis (8.4%  v  2.1%, respectively), and neuropathy (18.6%  v  3.3%, respectively). Five treatment-related deaths (2.1%) occurred in each arm.
CONCLUSION


In the 50303 study population, the more intensive, infusional DA-EPOCH-R was more toxic and did not improve PFS or OS compared with R-CHOP. The more favorable results with R-CHOP compared with historical controls suggest a potential patient selection bias and may preclude generalizability of results to specific risk subgroups.",2019,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","['524 patients were registered; 491 eligible patients were included in the final analysis', 'Between 2005 and 2013', 'diffuse large B-cell lymphoma', 'Patients received six cycles of', 'Diffuse Large B-Cell Lymphoma']","['Dose-Adjusted EPOCH-R Compared With R-CHOP', 'etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'DA-EPOCH-R or R-CHOP']","['febrile neutropenia', 'PFS or OS', 'mucositis', 'stage III or IV disease; International Prognostic Index', 'progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety', 'Grade 3 and 4 adverse events', 'infection', '2-year PFS rate', 'neuropathy', '2-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4520227', 'cui_str': 'Dose-adjusted EPOCH'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",524.0,0.170783,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': '4 Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '6 MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': '7 University of Rochester, Rochester, NY.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nina D', 'Initials': 'ND', 'LastName': 'Wagner-Johnston', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': '8 The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Abramson', 'Affiliation': '9 Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Nishitha M', 'Initials': 'NM', 'LastName': 'Reddy', 'Affiliation': '10 Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': '11 Northwestern University, Chicago, IL.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': '12 University of Wisconsin, Madison, WI.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': '13 Univeristy of Washington, Seattle, WA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': '15 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': '16 University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01994']
403,31271239,Glucose management for rewards: A randomized trial to improve glucose monitoring and associated self-management behaviors in adolescents with type 1 diabetes.,"BACKGROUND


This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring of blood glucose (SMBG) among youth with poorly controlled type 1 diabetes.
METHODS


After a 2-week baseline, 60 participants were randomized to enhanced usual care (EUC) or Reinforcers. The Reinforcers group earned monetary rewards for SMBG and associated behaviors such as uploading glucose meters. Reinforcers were withdrawn at 24 weeks. A follow-up evaluation occurred at 36 weeks.
RESULTS


Participants in the reinforcers group increased the proportion of days they completed ≥4 SMBG from 14.6% at baseline to 64.4%, 47.5%, and 37.8% at 6, 12, and 24 weeks, respectively. In contrast, EUC participants declined from 22.7% at baseline to 17.5%, 10.5%, and 11.1% (Ps < .01 vs EUC at all time points). Group differences were attenuated but remained significant after withdrawal of reinforcers. Effect sizes for SMBG were very large during reinforcement and large after withdrawal of reinforcers. In the reinforcers group, mean A1c dropped from 9.5% ± 1.2% at baseline to 9.0% ± 1.3% at week 6 and 9.0% ± 1.4% at week 12. For EUC, A1c was 9.2% ± 0.2% at baseline and ranged from 9.2% ± 1.5% to 9.6% ± 1.6% throughout the study (P < .05 vs EUC). Group differences in A1c were no longer significant at weeks 24 and 36. Effect sizes for A1c were small during reinforcement and also after withdrawal of reinforcement.
CONCLUSIONS


Monetary-based reinforcement of adolescents with type 1 diabetes caused durable increases in SMBG. Modification of the reinforcement structure may be needed to sustain improved metabolic control in this challenging age group.",2019,Group differences in A1c were no longer significant at weeks 24 and 36.,"['60 participants were randomized to', 'youth with poorly controlled type 1 diabetes', 'adolescents with type 1 diabetes', 'rewards']","['enhanced usual care (EUC) or Reinforcers', 'monetary-based reinforcement intervention']","['self-monitoring blood glucose (SMBG', 'mean A1c', 'proportion of days they completed >4 SMBG', 'SMBG']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",60.0,0.0605448,Group differences in A1c were no longer significant at weeks 24 and 36.,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Wagner', 'Affiliation': 'Behavioral Sciences & Community Health, University of Connecticut School of Dental Medicine, Farmington, Connecticut.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Petry', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Weyman', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tichy', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}, {'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Zajac', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': ""Yale Children's Diabetes Program, Yale University School of Medicine, New Haven, Connecticut.""}]",Pediatric diabetes,['10.1111/pedi.12889']
404,31759333,Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression.,"Repeated administration of subanesthetic intravenous ketamine may prolong the rapid decrease in suicidal ideation (SI) elicited by single infusions. The purpose of this secondary analysis was to evaluate reduction in SI with a single ketamine infusion compared with an active control, and prolonged suppression of SI with repeated and maintenance infusions. Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single ketamine infusion during a randomized, double-blind crossover with midazolam. Following relapse of depressive symptoms, participants received six open-label ketamine infusions administered thrice-weekly over 2 weeks. Antidepressant responders (≥50% decrease in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) received four further open-label infusions administered once-weekly. Changes in SI were assessed with the suicide items on the MADRS (item 10, MADRS-SI) and the Quick Inventory of Depressive Symptomatology-Self Report (item 12, QIDS-SI). Linear mixed models revealed that compared with midazolam, a single ketamine infusion elicited larger reduction in SI (P = 0.01), with maximal effects measured at 7 days postinfusion (P < 0.001, Cohen's d = 0.83). Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94). QIDS-SI results were consistent with MADRS-SI. Overall, 69% of participants had a complete alleviation of SI following repeated infusions. In TRD, single and repeated ketamine infusions resulted in decreases in SI which were maintained with once-weekly maintenance infusions. This study adds to the growing body of research suggesting ketamine as a possible novel treatment strategy for SI in mood disorders.",2020,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).",['Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single'],"['midazolam', 'six open-label ketamine', 'ketamine', 'subanesthetic intravenous ketamine', 'ketamine infusion', 'ketamine infusions']","['Changes in SI', 'Quick Inventory of Depressive Symptomatology-Self Report', 'cumulative reductions in MADRS-SI scores', 'suicidal ideation (SI', 'SI', 'suicidal ideation', 'Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'complete alleviation of SI']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",37.0,0.234581,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Sandhaya', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Owoeye', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Batten', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0570-x']
405,30923313,The impact of integrated disease management in high-risk COPD patients in primary care.,"Patients with chronic obstructive pulmonary disease (COPD) have a reduced quality of life (QoL) and exacerbations that drive health service utilization (HSU). A majority of patients with COPD are managed in primary care. Our objective was to evaluate an integrated disease management, self-management, and structured follow-up intervention (IDM) for high-risk patients with COPD in primary care. This was a one-year multi-center randomized controlled trial. High-risk, exacerbation-prone COPD patients were randomized to IDM provided by a certified respiratory educator and physician, or usual physician care. IDM received case management, self-management education, and skills training. The primary outcome, COPD-related QoL, was measured using the COPD Assessment Test (CAT). Of 180 patients randomized from 8 sites, 81.1% completed the study. Patients were 53.6% women, mean age 68.2 years, post-bronchodilator FEV 1  52.8% predicted, and 77.4% were Global Initiative for Obstructive Lung Disease Stage D. QoL-CAT scores improved in IDM patients, 22.6 to 14.8, and worsened in usual care, 19.3 to 22.0, adjusted difference 9.3 (p < 0.001). Secondary outcomes including the Clinical COPD Questionnaire, Bristol Knowledge Questionnaire, and FEV1 demonstrated differential improvements in favor of IDM of 1.29 (p < 0.001), 29.6% (p < 0.001), and 100 mL, respectively (p = 0.016). Compared to usual care, significantly fewer IDM patients had a severe exacerbation, -48.9% (p < 0.001), required an urgent primary care visit for COPD, -30.2% (p < 0.001), or had an emergency department visit, -23.6% (p = 0.001). We conclude that IDM self-management and structured follow-up substantially improved QoL, knowledge, FEV1, reduced severe exacerbations, and HSU, in a high-risk primary care COPD population. Clinicaltrials.gov NCT02343055.",2019,"Compared to usual care, significantly fewer IDM patients had a severe exacerbation, -48.9% (p < 0.001), required an urgent primary care visit for COPD, -30.2% (p < 0.001), or had an emergency department visit, -23.6% (p = 0.001).","['high-risk patients with COPD in primary care', 'high-risk COPD patients in primary care', 'High-risk, exacerbation-prone COPD patients', '180 patients randomized from 8 sites, 81.1% completed the study', 'Patients were 53.6% women, mean age 68.2 years, post-bronchodilator FEV 1  52.8% predicted, and 77.4% were Global Initiative for Obstructive Lung Disease Stage D', 'Patients with chronic obstructive pulmonary disease (COPD']",[],"['severe exacerbation', 'COPD-related QoL, was measured using the COPD Assessment Test (CAT', 'quality of life (QoL) and exacerbations that drive health service utilization (HSU', 'QoL, knowledge, FEV1, reduced severe exacerbations, and HSU', 'QoL-CAT scores', 'Clinical COPD Questionnaire, Bristol Knowledge Questionnaire, and FEV1 demonstrated differential improvements in favor of IDM']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0600260', 'cui_str': 'Obstructive Pulmonary Diseases'}, {'cui': 'C0441789', 'cui_str': 'Stage D (qualifier value)'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0034380'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",180.0,0.132384,"Compared to usual care, significantly fewer IDM patients had a severe exacerbation, -48.9% (p < 0.001), required an urgent primary care visit for COPD, -30.2% (p < 0.001), or had an emergency department visit, -23.6% (p = 0.001).","[{'ForeName': 'Madonna', 'Initials': 'M', 'LastName': 'Ferrone', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada.'}, {'ForeName': 'Marcello G', 'Initials': 'MG', 'LastName': 'Masciantonio', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Malus', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Stitt', 'Affiliation': 'Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': ""O'Callahan"", 'Affiliation': 'Amherstburg Family Health Team, Amherstburg, ON, Canada.'}, {'ForeName': 'Zofe', 'Initials': 'Z', 'LastName': 'Roberts', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Chatham Kent Family Health Team, Chatham, ON, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Samson', 'Affiliation': 'Leamington Family Health Team, Leamington, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Durocher', 'Affiliation': 'Leamington Family Health Team, Leamington, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Windsor Family Health Team, Windsor, ON, Canada.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Reilly', 'Affiliation': 'Harrow Family Health Team, Harrow, ON, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Griffiths', 'Affiliation': 'Tilbury Family Health Team, Tilbury, ON, Canada.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Licskai', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada. clicskai@uwo.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",NPJ primary care respiratory medicine,['10.1038/s41533-019-0119-9']
406,30500925,Impact of E-cigarette Sampling on Cigarette Dependence and Reinforcement Value.,"INTRODUCTION


E-cigarettes have risen in prevalence in recent years, and most public health experts agree they deliver fewer toxicants than combustible tobacco products such as cigarettes. Thus, it is important to understand how use of e-cigarettes by current smokers impacts dependence on combustible cigarettes.
METHODS


The present study is a secondary analysis of a randomized pilot trial of e-cigarette sampling. Nontreatment seeking current smokers were randomized in a 2:1 ratio to either receive or not receive a weekly supply of e-cigarettes for 3 weeks. Participants completed the Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM) scale and the cigarette purchase task before and after the sampling period and at monthly follow-up visits for 3 months.
RESULTS


Individuals assigned to receive an e-cigarette had significantly lower mean WISDM scores at the end of sampling and the end of the follow-up period compared with those in the control group. Both frequency of e-cigarette use as well as nicotine concentration of the e-cigarette given to smokers were significant predictors of changes in the mean WISDM score. E-cigarette sampling significantly reduced the demand parameter Omax, which measures the maximum amount of money participants estimate they would spend on cigarettes in a single day.
CONCLUSIONS


These data suggest that current smokers who try using an e-cigarette may experience reductions in dependence on combustible cigarettes.
IMPLICATIONS


The present analysis suggests that providing an e-cigarette to current cigarette smokers is likely to reduce cigarette dependence, especially if the e-cigarette delivers sufficient nicotine and is used frequently.",2020,"Results


Individuals assigned to receive an e-cigarette had significantly lower mean WISDM scores at the end of sampling and the end of the follow-up period compared to those in the control group.",['e-cigarette sampling. Non-treatment seeking current smokers'],['e-cigarette sampling'],"['mean WISDM scores', 'Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM) scale and the Cigarette Purchase Task (CPT', 'cigarette dependence and reinforcement value']","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3241966'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0133065,"Results


Individuals assigned to receive an e-cigarette had significantly lower mean WISDM scores at the end of sampling and the end of the follow-up period compared to those in the control group.","[{'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Cancer Control and Prevention, Hollings Cancer Center, MUSC, Charleston, SC.'}, {'ForeName': 'Bryan W', 'Initials': 'BW', 'LastName': 'Heckman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Cummings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty258']
407,31791039,Mechanistic link between right prefrontal cortical activity and anxious arousal revealed using transcranial magnetic stimulation in healthy subjects.,"Much of the mechanistic research on anxiety focuses on subcortical structures such as the amygdala; however, less is known about the distributed cortical circuit that also contributes to anxiety expression. One way to learn about this circuit is to probe candidate regions using transcranial magnetic stimulation (TMS). In this study, we tested the involvement of the dorsolateral prefrontal cortex (dlPFC), in anxiety expression using 10 Hz repetitive TMS (rTMS). In a within-subject, crossover experiment, the study measured anxiety in healthy subjects before and after a session of 10 Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC). It used threat of predictable and unpredictable shock to induce anxiety and anxiety potentiated startle to assess anxiety. Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS. These results suggest a mechanistic link between right dlPFC activity and physiological anxiety expression. This result supports current models of prefrontal asymmetry in affect, and lays the groundwork for further exploration into the cortical mechanisms mediating anxiety, which may lead to novel anxiety treatments.",2020,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","['healthy subjects before and after a session of 10\u2009Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC', 'healthy subjects']","['10\u2009Hz repetitive TMS (rTMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']",['anxiety-potentiated startle'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0106782,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0583-5']
408,30892637,Pharmacokinetic Profile of Spectrum Reduced Nicotine Cigarettes.,"INTRODUCTION


Spectrum research cigarettes have been developed with varying nicotine content for use in studies evaluating the effects of a regulatory policy reducing the permissible nicotine content in cigarettes. This study aimed to characterize the nicotine pharmacokinetic profile of Spectrum cigarettes.
METHODS


Twelve daily smokers attended four sessions and had blood nicotine, exhaled carbon monoxide, and subjective effects measured before and after smoking either a single cigarette of their preferred brand or high (10.9 mg/cigarette), medium (3.2 mg/cigarette), or low (0.2 mg/cigarette) nicotine content Spectrum research cigarettes, in a double-blind design with order counterbalanced.
RESULTS


The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9, and 17.3 ng/mL for low-, medium-, and high-nicotine content Spectrum cigarettes. The high dose Spectrum had a similar nicotine boost to the ""preferred brand"" cigarettes (19 ng/mL). Subjects took longer puffs on the low nicotine cigarettes, but smoked these cigarettes faster than other cigarette types. High nicotine Spectrum cigarettes reduced the urge to smoke more than other cigarette types.
CONCLUSIONS


This study shows that Spectrum research cigarettes produce blood nicotine absorption in a dose-dependent manner, and therefore, are appropriate for use in studies of nicotine reduction in cigarettes.
IMPLICATIONS


This is the first study to determine the pharmacokinetic profile of Spectrum reduced nicotine content research cigarettes following an overnight abstinence. These data could provide evidence to regulatory agencies about the effects of reduced nicotine cigarettes when considering regulations on tobacco reduction.",2020,"The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9 and 17.3 ng/ml for low, medium, and high nicotine content Spectrum cigarettes.","['12 daily smokers attended 4 sessions and had blood nicotine, exhaled carbon monoxide (CO) and subjective effects measured before and after smoking either a single cigarette of their preferred brand or high (10.9 mg/cig']","['medium (3.2 mg/cig) or very low (0.2 mg/cig) nicotine content Spectrum research cigarettes, in a double-blind design with order counter-balanced', 'nicotine Spectrum cigarettes']",['blood nicotine concentration'],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0005768'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0035168'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0005768'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0278229,"The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9 and 17.3 ng/ml for low, medium, and high nicotine content Spectrum cigarettes.","[{'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Kamens', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Constanza P', 'Initials': 'CP', 'LastName': 'Silva', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Russell T', 'Initials': 'RT', 'LastName': 'Nye', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Carley N', 'Initials': 'CN', 'LastName': 'Miller', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Nayantara', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sipko', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Trushin', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Dongxiao', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmacology, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Branstetter', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Muscat', 'Affiliation': 'Penn State Cancer Institute, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Richie', 'Affiliation': 'Penn State Cancer Institute, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Penn State Cancer Institute, Pennsylvania State University, Hershey, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz045']
409,30820567,"Concurrent Alcohol Use and Waterpipe Tobacco Smoking: Smoking Topography, Toxicant Exposure, and Abuse Liability.","INTRODUCTION


Relative to non-waterpipe (WP) smokers, WP smokers are more than twice as likely to use alcohol and frequently consume alcohol before or during smoking sessions. Co-use of alcohol and WP may result in greater toxicant exposure compared to WP smoking alone. To date, no study systematically has investigated the impact of acute alcohol intoxication on WP smoking topography, exposure to tobacco-related toxicants, or abuse liability.
METHODS


Dyads of current WP smokers and drinkers (N = 42; age = 21-32 years) completed two in-laboratory ad libitum smoking sessions (≤2 hours) following 12-hour nicotine abstinence in a double-blind, randomized crossover design in which they consumed a placebo versus active drink (sustained breath alcohol concentration = .08). Exhaled carbon monoxide (eCO) and plasma nicotine concentration were assessed. Questionnaires assessed smoking experience and smoking urge. Smoking topography was measured continuously throughout each smoking session.
RESULTS


The alcohol session was associated with increased inhaled volume, flow rate, and WP session duration compared to placebo. Compared to placebo, participants reported a more positive overall smoking experience following the alcohol session and greater smoking urges pre- and post-smoking session. Although both sessions resulted in significant increases in eCO and plasma nicotine, no significant differences emerged in eCO or nicotine exposure between the active and placebo sessions.
CONCLUSIONS


Co-use of alcohol and WP may contribute to the maintenance of WP smoking through enhanced smoking experiences, increased urge to smoke, and significant exposure to addictive nicotine. Regulations may be necessary to limit the sale of alcohol in WP smoking lounges and reduce exposure to secondhand smoke.
IMPLICATIONS


The findings suggest co-use of alcohol and WP tobacco likely maintain WP use and dependence by enhancing the smoking experience and increasing urges to smoke. These findings have implications for regulations aimed at limiting co-use of alcohol and WP tobacco in WP lounges and limiting exposure to secondhand smoke.
CLINICAL TRIALS REGISTRATION


NCT03096860.",2020,"Compared to placebo, participants reported a more positive overall smoking experience following the alcohol session and greater smoking urges pre- and post-smoking session.",['Dyads of current WP smokers and drinkers (N=42; age=21-32 years) completed two in'],"['Concurrent alcohol use and waterpipe tobacco smoking', 'laboratory ad libitum smoking sessions (≤2-hours) following 12-hour nicotine abstinence', 'placebo']","['inhaled volume, flow rate, and WP session duration', 'Smoking topography, toxicant exposure, and abuse liability', 'eCO or nicotine exposure', 'eCO and plasma nicotine', 'Questionnaires assessed smoking experience and smoking urge', 'Exhaled carbon monoxide (eCO) and plasma nicotine concentration', 'positive overall smoking experience', 'Smoking topography']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C4505131', 'cui_str': 'Tobacco, Waterpipe'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0120395,"Compared to placebo, participants reported a more positive overall smoking experience following the alcohol session and greater smoking urges pre- and post-smoking session.","[{'ForeName': 'Eleanor L S', 'Initials': 'ELS', 'LastName': 'Leavens', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Morgan', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Emma I', 'Initials': 'EI', 'LastName': 'Brett', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Patzkowsky', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Son', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Molina', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Shihadeh', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Thad R', 'Initials': 'TR', 'LastName': 'Leffingwell', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK.'}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'Wagener', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz032']
410,32272037,Re: Bladder Preservation with Twice-a-Day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine for Muscle-Invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial.,,2020,,['Muscle-Invasive Bladder Cancer'],['Re: Bladder Preservation with Twice-a-Day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine'],[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]",[],,0.0405648,,"[{'ForeName': 'Sam S', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001055']
411,32193413,In-line filtration in very preterm neonates: a randomized controlled trial.,"In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in very preterm neonates, remain to be demonstrated. We conducted a randomized controlled trial among very preterm infants allocated to receive either in-line filtration of all the intra-venous lines or standard care without filters. The primary outcome was differences greater than 20% in the median changes in pro-inflammatory cytokine serum concentrations measured at day 3 and day 8 (+/-1) using a Luminex multianalytic profiling technique. Major neonatal complications were analyzed as secondary predefined outcomes. We randomized 146 infants, assigned to filter (n = 73) or control (n = 73) group. Difference over 20% in pro-inflammatory cytokine concentration between day 3 and day 8 was not found statistically different between the two groups, both in intent-to-treat (with imputation) and per protocol (without imputation) analyses. The incidences of most of neonatal complications were found to be similar. Hence, this trial did not evidence a beneficial effect of in-line filtration in very preterm infants on the inflammatory response syndrome and neonatal morbidities. These data should be interpreted according to local standards in infusion preparation and central line management.",2020,"Difference over 20% in pro-inflammatory cytokine concentration between day 3 and day 8 was not found statistically different between the two groups, both in intent-to-treat (with imputation) and per protocol (without imputation) analyses.","['146 infants, assigned to filter (n\u2009=\u200973) or control (n\u2009=\u200973) group', 'very preterm neonates', 'very preterm infants allocated to']",['receive either in-line filtration of all the intra-venous lines or standard care without filters'],"['neonatal complications', 'Major neonatal complications', 'pro-inflammatory cytokine concentration', 'median changes in pro-inflammatory cytokine serum concentrations']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0445377', 'cui_str': 'Venous line (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",146.0,0.215929,"Difference over 20% in pro-inflammatory cytokine concentration between day 3 and day 8 was not found statistically different between the two groups, both in intent-to-treat (with imputation) and per protocol (without imputation) analyses.","[{'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Virlouvet', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Neonatal intensive care unit, Robert Debré children's hospital, Paris, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Pansiot', 'Affiliation': 'Delegation Paris 7, Inserm U1141, University of Paris, Paris, France.'}, {'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Toumazi', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Unit of Clinical Epidemiology, Robert Debré children's hospital, University of Paris, Inserm U1123 and CIC-EC, 1426, Paris, France.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Colella', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Neonatal intensive care unit, Robert Debré children's hospital, Paris, France.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Capewell', 'Affiliation': 'Pall Medical, SLS, Dreieich, Germany.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Guerriero', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Department of Pharmacy, Robert Debré children's hospital, Paris, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Storme', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Department of Pharmacy, Robert Debré children's hospital, Paris, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Rioualen', 'Affiliation': 'Department of Neonatal Medicine, Brest University Hospital, Brest, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Bourmaud', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Unit of Clinical Epidemiology, Robert Debré children's hospital, University of Paris, Inserm U1123 and CIC-EC, 1426, Paris, France.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Biran', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Neonatal intensive care unit, Robert Debré children's hospital, Paris, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Baud', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Neonatal intensive care unit, Robert Debré children's hospital, Paris, France. olivier.baud@hcuge.ch.""}]",Scientific reports,['10.1038/s41598-020-61815-4']
412,32193512,Changing accommodation behaviour during multifocal soft contact lens wear using auditory biofeedback training.,"Biofeedback training has been used to access autonomically-controlled body functions through visual or acoustic signals to manage conditions like anxiety and hyperactivity. Here we examined the use of auditory biofeedback to improve accommodative responses to near visual stimuli in patients wearing single vision (SV) and multifocal soft contact lenses (MFCL). MFCLs are one evidence-based treatment shown to be effective in slowing myopia progression in children. However, previous research found that the positive addition relaxed accommodation at near, possibly reducing the therapeutic benefit. Accommodation accuracy was examined in 18 emmetropes and 19 myopes while wearing SVCLs and MFCLs (centre-distance). Short periods of auditory biofeedback training to improve the response (reduce the lag of accommodation) was performed and accommodation re-assessed while patients wore the SVCLs and MFCLs. Significantly larger accommodative lags were measured with MFCLs compared to SV. Biofeedback training effectively reduced the lag by ≥0.3D in individuals of both groups with SVCL and MFCL wear. The training was more effective in myopes wearing their habitual SVCLs. This study shows that accommodation can be changed with short biofeedback training independent of the refractive state. With this proof-of-concept, we hypothesize that biofeedback training in myopic children wearing MFCLs might improve the treatment effectiveness.",2020,Biofeedback training effectively reduced the lag by ≥0.3D in individuals of both groups with SVCL and MFCL wear.,"['individuals of both groups with SVCL and MFCL wear', 'patients wearing single vision (SV) and multifocal soft contact lenses (MFCL']","['auditory biofeedback training', 'auditory biofeedback', 'Biofeedback training', 'biofeedback training']","['accommodative lags', 'Accommodation accuracy']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}]",,0.0273574,Biofeedback training effectively reduced the lag by ≥0.3D in individuals of both groups with SVCL and MFCL wear.,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Institute for Ophthalmic Research, Eberhard Karls University Tuebingen, Elfriede-Aulhorn-Str. 7, 72076, Tuebingen, Germany. sandra.wagner@uni-tuebingen.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schaeffel', 'Affiliation': 'Section Neurobiology of the Eye, Institute for Ophthalmic Research, Eberhard Karls University Tuebingen, Elfriede-Aulhorn-Str. 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Troilo', 'Affiliation': 'State University of New York, College of Optometry, 33 West 42nd Street, New York, NY, 10036, United States.'}]",Scientific reports,['10.1038/s41598-020-61904-4']
413,32193472,A Painless and Time-Saving Modified Technique for Simple Renal Cyst Treatment with Single-session Ethanol Sclerotherapy.,"Percutaneous puncture ethanol sclerotherapy is a simple, effective, minimally invasive, and inexpensive procedure to manage symptomatic simple renal cysts. We modified specific technical aspects to balance certain potential intraprocedural factors for ensuring minimal procedural pain and duration as well as maximal clinical therapeutic effects and evaluated the safety and efficacy of this modified technique. A total of 84 eligible patients underwent computed tomography-guided single-session ethanol sclerotherapy using the conventional (group A) or modified (group B) technique. In group B, the puncture route was modified from tansparenchymal to direct for reducing renal injury, and preinjection of low-dose intracystic lidocaine was used to control distending pain caused by ethanol injections; therefore, greater ethanol volumes could be injected for improving the resistance and contact of ethanol with the cyst wall, precluding the need for patient repositioning multiple times to decrease procedural duration. Visual analog scale score for pain and procedural time were significantly higher in group A than in group B. The complication rate was slightly higher in group A than in group B, but the success rate was comparable between the two groups. These results suggest that the modified technique is painless, time-saving, and injury-reducing and can thus improve medical care.",2020,"Percutaneous puncture ethanol sclerotherapy is a simple, effective, minimally invasive, and inexpensive procedure to manage symptomatic simple renal cysts.",['84 eligible patients underwent'],"['Single-session Ethanol Sclerotherapy', 'Percutaneous puncture ethanol sclerotherapy', 'computed tomography-guided single-session ethanol sclerotherapy using the conventional (group A) or modified (group B) technique', 'lidocaine']","['Visual analog scale score for pain and procedural time', 'complication rate', 'success rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",84.0,0.0146245,"Percutaneous puncture ethanol sclerotherapy is a simple, effective, minimally invasive, and inexpensive procedure to manage symptomatic simple renal cysts.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, Dianjiang County People's Hospital of Chongqing, Chongqing, 408300, P.R. China.""}, {'ForeName': 'Shi-Hua', 'Initials': 'SH', 'LastName': 'Xiong', 'Affiliation': ""Department of Urology, Dianjiang County People's Hospital of Chongqing, Chongqing, 408300, P.R. China.""}, {'ForeName': 'Xu-Jing', 'Initials': 'XJ', 'LastName': 'Jiang', 'Affiliation': ""Department of General Surgery, Dianjiang County People's Hospital of Chongqing, Chongqing, 408300, P.R. China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, Dianjiang County People's Hospital of Chongqing, Chongqing, 408300, P.R. China.""}, {'ForeName': 'Ya-Yun', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, Dianjiang County People's Hospital of Chongqing, Chongqing, 408300, P.R. China.""}, {'ForeName': 'Fa-Jin', 'Initials': 'FJ', 'LastName': 'Lyu', 'Affiliation': 'Department of Radiology, First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China, P.R. China. fajinlyu@hotmail.com.'}]",Scientific reports,['10.1038/s41598-020-61842-1']
414,32402554,"Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study).","PURPOSE


Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial.
DESIGN


Multicenter cohort study.
PARTICIPANTS


Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion).
METHODS


Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit.
MAIN OUTCOME MEASURES


Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST).
RESULTS


Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0-12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3-14.5) better than baseline but 4.8 letters (95% CI, 2.5-7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4-5.0) better than baseline but 4.6 letters (95% CI, 3.1-6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142-166) and was stable between 2 and 5 years (-1 μm; 95% CI, -12 to 9).
CONCLUSIONS


Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.",2020,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","['Participants', 'Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion', 'for center-involved diabetic macular edema (CI-DME', 'eyes with DME']","['anti-VEGF therapy', 'aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment', 'Aflibercept, Bevacizumab, or Ranibizumab']","['Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST', '5-year visit, mean VA', '5-year visit', 'mean 5-year VA', 'Mean CST', 'mean retinal thickness', 'mean VA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]",,0.306087,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wells', 'Affiliation': 'Palmetto Retina Center, Columbia, South Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Josic', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, North Carolina.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Elman', 'Affiliation': 'Elman Retina Group, Pikesville, Maryland.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.021']
415,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND


Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition.
METHODS


In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment.
RESULTS


All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
CONCLUSIONS


Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up.
IMPACT


The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up. The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8']
416,32401221,A Mobile Health App for the Collection of Functional Outcomes After Inpatient Stroke Rehabilitation: Pilot Randomized Controlled Trial.,"BACKGROUND


Monitoring the functional status of poststroke patients after they transition home is significant for rehabilitation. Mobile health (mHealth) technologies may provide an opportunity to reach and follow patients post discharge. However, the feasibility and validity of functional assessments administered by mHealth technologies are unknown.
OBJECTIVE


This study aimed to evaluate the feasibility, validity, and reliability of functional assessments administered through the videoconference function of a mobile phone-based app compared with administration through the telephone function in poststroke patients after rehabilitation hospitalization.
METHODS


A randomized controlled trial was conducted in a rehabilitation hospital in Southeast China. Participants were randomly assigned to either a videoconference follow-up (n=60) or a telephone follow-up (n=60) group. We measured the functional status of participants in each group at 2-week and 3-month follow-up periods. Half the participants in each group were followed by face-to-face home visit assessments as the gold standard. Validity was assessed by comparing any score differences between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Reliability was assessed by computing agreements between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Feasibility was evaluated by the levels of completion, satisfaction, comfort, and confidence in the 2 groups.
RESULTS


Scores obtained from the videoconference follow-up were similar to those of the home visit assessment. However, most scores collected from telephone administration were higher than those of the home visit assessment. The agreement between videoconference follow-up and home visit assessments was higher than that between telephone follow-up and home visit assessments at all follow-up periods. In the telephone follow-up group, completion rates were 95% and 82% at 2-week and 3-month follow-up points, respectively. In the videoconference follow-up group, completion rates were 95% and 80% at 2-week and 3-month follow-up points, respectively. There were no differences in the completion rates between the 2 groups at all follow-up periods (X 2 1 =1.6, P=.21 for 2-week follow-up; X 2 1 =1.9, P=.17 for 3-month follow-up). Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up). The videoconference follow-up group demonstrated higher satisfaction than the telephone follow-up group at 3-month follow-up (X 2 3 =13.9; P=.03).
CONCLUSIONS


The videoconference follow-up assessment of functional status demonstrates higher validity and reliability, as well as higher confidence and satisfaction perceived by patients, than the telephone assessment. The videoconference assessment provides an efficient means of assessing functional outcomes of patients after hospital discharge. This method provides a novel solution for clinical trials requiring longitudinal assessments.
TRIAL REGISTRATION


chictr.org.cn: ChiCTR1900027626; http://www.chictr.org.cn/edit.aspx?pid=44831&htm=4.",2020,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","['patients after hospital discharge', 'rehabilitation hospital in Southeast China', 'poststroke patients after rehabilitation hospitalization']","['videoconference follow-up (n=60) or a telephone follow-up', 'mobile phone-based app compared with administration through the telephone function']","['Reliability', 'completion rates', 'higher satisfaction', 'levels of completion, satisfaction, comfort, and confidence', 'higher confidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0461705,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Shanjia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Guanli', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Chetwyn C H', 'Initials': 'CCH', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, HongKong, Hong Kong.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Alex W K', 'Initials': 'AWK', 'LastName': 'Wong', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine, St. Louis, MO, United States.'}]",JMIR mHealth and uHealth,['10.2196/17219']
417,32193820,Effect of diode laser application as an adjunct to nonsurgical periodontal therapy on the reduction of red complex microorganisms in type 2 diabetics with chronic periodontitis.,"Bactericidal and detoxification effects of diode laser (DL) have been reported in periodontal treatment. The objective of this study was investigating the additional effect of DL with nonsurgical periodontal treatment on the red complex bacteria in type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP). Sixty type 2 DM patients with chronic periodontitis (CP) were randomly assigned in two parallel groups to receive scaling root planning (SRP, n = 30) or SRP followed by DL periodontal pocket irradiation (SRP + DL, n = 30). Recording of clinical parameters and subgingival plaque sampling were performed at baseline, and post therapy (1 and 3 months after treatment). Amounts of Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia were evaluated with quantitative RT-PCR. Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points. No additional benefit of DL as an adjunct to nonsurgical periodontal therapy was recognized in the reduction of P. gingivalis, T. denticola, and T. forsythia for type 2 DM patients with CP. Further studies are required to clarify the effects of diode laser on the other periodontopathogens.",2020,"Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points.","['Sixty type 2 DM patients with chronic periodontitis (CP', 'type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP', 'type 2 diabetics with chronic periodontitis']","['diode laser application', 'diode laser (DL', 'DL', 'scaling root planning (SRP, n\u2009=\u200930) or SRP followed by DL periodontal pocket irradiation (SRP + DL, n\u2009=\u200930', 'diode laser']","['bacterial reductions', 'Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia', 'red complex microorganisms']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0031094', 'cui_str': 'Periodontal Pocket'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0314961', 'cui_str': 'Bacteroides forsythus'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}]",60.0,0.0363979,"Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points.","[{'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Kocak', 'Affiliation': 'Izzet Baysal Mouth and Dental Health Center, Bolu, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sağlam', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey. dtmehmetsaglam@gmail.com.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Arslan', 'Affiliation': 'Department of Microbiology, School of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Seyit Ali', 'Initials': 'SA', 'LastName': 'Kayis', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Karabük University, Karabuk, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kebapcilar', 'Affiliation': 'Department of Endocrinology and Metabolism Disease, School of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Loos', 'Affiliation': 'Department of Periodontology, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sema S', 'Initials': 'SS', 'LastName': 'Hakki', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Selcuk University, Konya, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-02997-1']
418,31295363,"Higher dietary protein intake preserves lean body mass, lowers liver lipid deposition, and maintains metabolic control in participants with long-chain fatty acid oxidation disorders.","Medical nutrition therapy for long-chain fatty acid oxidation disorders (LC-FAODs) currently emphasizes fasting avoidance, restricted dietary long-chain fatty acid intake, supplementation with medium chain triglycerides, and increased carbohydrate intake. We hypothesize that increasing dietary protein intake relative to carbohydrate intake would preserve metabolic control yet induce physical benefits including reduced hepatic lipogenesis. Therefore, we compared two dietary approaches with similar fat intake but different carbohydrate to protein ratios in participants diagnosed with LC-FAODs. Thirteen participants were enrolled and randomized into either a high-protein (PRO) or a high-carbohydrate (CHO) diet for 4 months. Baseline and 4-month assessments included body composition, ectopic lipid deposition, and resting energy expenditure. End of study assessments also included total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity. At the end of the dietary intervention, both groups had similar energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads. Neither dietary group experienced worsening symptoms related to their LC-FAOD. Compared to the CHO group, the PRO group exhibited increased blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass while the CHO group lost lean mass. In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass. We propose that a modest increase in dietary protein along with fasting avoidance and fat restriction may improve body composition and energy expenditure in patients with LC-FAODs.",2019,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","['participants with long-chain fatty acid oxidation disorders', 'Thirteen participants', 'participants diagnosed with LC-FAODs', 'patients with LC-FAODs']","['high-protein (PRO) or a high-carbohydrate (CHO) diet', 'CHO', 'Medical nutrition therapy']","['total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity', 'blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass', 'body composition and energy expenditure', 'lean body mass, lowers liver lipid deposition', 'energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads', 'worsening symptoms', 'body composition, ectopic lipid deposition, and resting energy expenditure']","[{'cui': 'C0522095', 'cui_str': 'Long chain fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet (finding)'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]","[{'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",13.0,0.0245497,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","[{'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'Gillingham', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Elizondo', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Behrend', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Matern', 'Affiliation': 'Biochemical Genetics Laboratory, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Schoeller', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Purnell', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12155']
419,32205226,Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma.,"BACKGROUND & AIMS


Patients with hepatocellular carcinoma (HCC) secondary to chronic liver disease often require invasive procedures but frequently have thrombocytopenia. Lusutrombopag is an agonist of the thrombopoietin receptor that activates platelet production.
METHODS


We performed an integrated analysis of data from 2 phase 3 trials (L-PLUS 1, Japan, October 2013 to May 2014, and L-PLUS 2, global, June 2015 to April 2017) that compared the efficacy and safety of lusutrombopag with placebo in patients with chronic liver disease, with and without HCC. Our analysis included patients with Eastern Cooperative Oncology Group grades of 0 or 1, Child-Pugh classes A or B, and a platelet count less than 50 × 10 9 /L who were scheduled to undergo invasive procedures in 9 to 14 days. Patients received lusutrombopag (3 mg) or placebo daily for 7 days or fewer before an invasive procedure. Imaging studies assessed treatment-emergent adverse events, including asymptomatic portal vein thrombosis. The primary end point was no requirement for platelet transfusion before the invasive procedure and rescue therapies for bleeding 7 days or fewer after the invasive procedure.
RESULTS


The per-protocol population included 270 patients (95 with HCC). A significantly higher proportion of patients with HCC who received lusutrombopag achieved the primary end point (68.0%) vs patients who received placebo (8.9%) (P < .0001); in patients without HCC, these proportions were 77.0% vs 21.6% (P < .0001). Lusutrombopag reduced the need for platelet transfusions, increased platelet counts for 3 weeks, and reduced the number of bleeding events in patients with and without HCC compared with placebo. Risk of thrombosis was similar to that of placebo.
CONCLUSIONS


Patients with and without HCC receiving lusutrombopag had a reduction in the number of platelet transfusions before invasive procedures compared with patients receiving placebo, with no increase in thrombosis or bleeding. L-PLUS 1: JapicCTI-132323; L-PLUS 2: ClinicalTrials.gov number no: NCT02389621.",2020,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","['patients with chronic liver disease, with and without HCC', '270 patients (95 with HCC', 'patients with ECOG grades of 0 or 1, Child', 'Patients with hepatocellular carcinoma (HCC', 'Patients With and Without Hepatocellular Carcinoma']","['placebo', 'lusutrombopag (3 mg) or placebo', 'Lusutrombopag', 'lusutrombopag to placebo']","['Risk of thrombosis', 'number of bleeding events', 'number of platelet transfusions', 'platelet counts', 'platelet transfusion', 'thrombosis or bleeding', 'asymptomatic portal vein thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4309207', 'cui_str': 'lusutrombopag'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis (disorder)'}]",,0.350149,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","[{'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Department of Metabolic Center, Texas Liver Institute, San Antonio, Texas. Electronic address: alkhouri@txliver.com.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Imawari', 'Affiliation': 'Institute for Gastrointestinal and Liver Disease, Shin-Yurigaoka General Hospital, Kawasaki, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Osaki', 'Affiliation': 'Meiwa Hospital, Nishinomiya, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Biostatistics Center, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Global Project Management Department, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Bentley', 'Affiliation': 'Global Market Access, Shionogi, Inc, Florham Park, New Jersey.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Trevisani', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.032']
420,31629852,NT-Pro BNP Predicts Myocardial Injury Post-vascular Surgery and is Reduced with CoQ 10 : A Randomized Double-Blind Trial.,"BACKGROUND


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


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


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


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


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


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


NT-Pro BNP levels predict adverse events post-vascular surgery and are lowered in those patients assigned to preoperative administration of CoQ 10 .","[{'ForeName': 'Asrar', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Johnson', 'Affiliation': 'Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Carlson', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hocum-Stone', 'Affiliation': 'Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN; Division of Cardiothoracic Surgery, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Rosemary F', 'Initials': 'RF', 'LastName': 'Kelly', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gravely', 'Affiliation': 'Department of Research Statistical Center, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Mackenzi', 'Initials': 'M', 'LastName': 'Mbai', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Derrick L', 'Initials': 'DL', 'LastName': 'Green', 'Affiliation': 'Division of Vascular Surgery, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Santilli', 'Affiliation': 'Division of Vascular Surgery, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Garcia', 'Affiliation': 'Division of Cardiology, Minneapolis Heart Institute, Minneapolis, MN.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Adabag', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'McFalls', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN. Electronic address: mcfal001@umn.edu.'}]",Annals of vascular surgery,['10.1016/j.avsg.2019.09.017']
421,31633185,Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: analysis of Japanese patients in CheckMate 214 with extended follow-up.,"BACKGROUND


Nivolumab plus ipilimumab (NIVO+IPI) demonstrated superior efficacy over sunitinib (SUN) for previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 214, with a manageable safety profile. We report efficacy and safety with extended follow-up amongst Japanese patients.
METHODS


CheckMate 214 patients received NIVO (3 mg/kg) plus IPI (1 mg/kg) every 3 weeks for four doses, then NIVO (3 mg/kg) every 2 weeks; or SUN (50 mg) once daily for 4 weeks (6-week cycle). This subgroup analysis assessed overall survival (OS), objective response rate (ORR) and progression-free survival (PFS) per investigator in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate/poor-risk and intent-to-treat (ITT) patients and safety (ITT patients).
RESULTS


Of 550 and 546 patients randomized to NIVO+IPI and SUN, 38 and 34, respectively, were Japanese. Of these, 31 (NIVO+IPI) and 29 (SUN) patients were IMDC intermediate/poor-risk. In IMDC intermediate/poor-risk patients with 30 months' minimum follow-up, there was a delayed trend in OS benefit with NIVO+IPI (hazard ratio [HR] 0.56; 95% confidence interval [CI]: 0.19-1.59; P = 0.2670), and 24-month OS probability favoured NIVO+IPI (84%) versus SUN (76%). The ORR was 39% with NIVO+IPI and 31% with SUN (P = 0.6968). PFS was similar in both treatment arms (HR 1.17; 95% CI: 0.62-2.20; P = 0.6220). Efficacy in ITT patients was similar to IMDC intermediate/poor-risk patients. Grade 3-4 treatment-related adverse event incidence was lower with NIVO+IPI versus SUN (58 versus 91%).
CONCLUSIONS


Japanese patients with untreated aRCC in the NIVO+IPI arm had a numerically higher ORR and improved safety profile versus patients in the SUN arm. A delayed OS benefit appears to be emerging with NIVO+IPI. Longer follow-up is needed. https://clinicaltrials.gov/ct2/show/NCT02231749?term=NCT02231749&rank=1 identifier: NCT02231749.",2020,The ORR was 39% with NIVO+IPI and 31% with SUN (P = 0.6968).,"['previously untreated advanced renal cell carcinoma (aRCC', 'Japanese patients', 'CheckMate 214 patients received', 'Japanese patients in CheckMate 214 with extended follow-up', 'previously untreated advanced renal-cell carcinoma', 'Of 550 and 546 patients randomized to NIVO+IPI and SUN, 38 and 34, respectively, were Japanese']","['NIVO (3\xa0mg/kg) plus IPI', 'sunitinib (SUN', 'SUN', 'Nivolumab plus ipilimumab versus sunitinib', 'Nivolumab plus ipilimumab (NIVO+IPI']","['IMDC intermediate/poor-risk', 'ORR', 'efficacy and safety', 'OS benefit with NIVO+IPI (hazard ratio [HR', 'Efficacy', 'overall survival (OS), objective response rate (ORR) and progression-free survival (PFS) per investigator in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate/poor-risk and intent-to-treat (ITT) patients and safety (ITT patients', 'adverse event incidence', 'PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0668760', 'cui_str': ""P(1),P(5)-di(inosine-5')pentaphosphate""}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",214.0,0.123299,The ORR was 39% with NIVO+IPI and 31% with SUN (P = 0.6968).,"[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Tsunenori', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Hospital, Tokyo, Japan.""}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Kimura', 'Affiliation': 'Department of Urology, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Takamitsu', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology, Akita University Hospital, Akita, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Wakumoto', 'Affiliation': 'Department of Urology, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Urology, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Urology, Hamamatsu University Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'Department of Surgery, Urology, Tokyo Medical and Dental University Hospital, University Hospital of Medicine, Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Obara', 'Affiliation': 'Department of Urology, Iwate Medical University Hospital, Morioka, Japan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology, Kinki University Hospital, Faculty of Medicine, Osakasayama, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyz132']
422,32198520,Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial.,"INTRODUCTION


Proactive, population health cessation programs can guide efforts to reach smokers outside of the clinic to encourage quit attempts and treatment use.
AIMS AND METHODS


This study aimed to measure trial feasibility and preliminary effects of a proactive intervention offering text messages (TM) and/or mailed nicotine replacement therapy (NRT) to smokers in primary care clinics. From 2017 to 2019 we performed a pilot randomized trial comparing brief telephone advice (control: BA), TM, 2 weeks of mailed NRT, or both interventions (TM + NRT). Patients were identified using electronic health records and contacted proactively by telephone to assess interest in the study. We compared quit attempts, treatment use, and cessation in the intervention arms with BA.
RESULTS


Of 986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment. On average, patients in the TM arms received 159 messages (99.4% sent, 0.6% failed), sent 19 messages, and stayed in the program for 61 days. In all groups, a majority of patients reported quit attempts (BA 67% vs. TM 86% [p = .07], NRT 81% [p = .18], TM + NRT 79% [p = .21]) and NRT use (BA 51% vs. NRT 83% [p = .007], TM 65% [p = .25], TM + NRT 76% [p = .03]). Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p = .09), NRT 28% (p = .06), and TM + NRT 23% (p = .14).
CONCLUSIONS


Proactively offering TM or mailed nicotine medications was feasible among primary care smokers and a promising approach to promote quit attempts and short-term abstinence.
IMPLICATIONS


Proactive intervention programs to promote quit attempts outside of office visits among smokers enrolled in primary care practices are needed. TM have potential to engage smokers not planning to quit or to support smokers to make a planned quit attempt. This pilot study demonstrates the feasibility of testing a proactive treatment model including TM and/or mailed NRT to promote quit attempts, treatment use, and cessation among nontreatment-seeking smokers in primary care.
CLINICALTRIALS.GOV IDENTIFIER


NCT03174158.",2020,"Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p=0.09), NRT 28% (p=0.06), and TM+NRT 23% (p=0.14).
","['smokers in primary care practices', 'From 2017-2019', '986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment', 'smokers in primary care clinics', 'primary care smokers']","['proactive intervention offering text messages and/or mailed nicotine replacement therapy (NRT', 'nicotine medications', 'telephone advice (control: BA), text messages (TM), 2-weeks of mailed NRT, or both interventions (TM+NRT', 'nicotine replacement therapy']","['7-day abstinence', 'quit attempts']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0423889,"Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p=0.09), NRT 28% (p=0.06), and TM+NRT 23% (p=0.14).
","[{'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Kruse', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Tobacco Research and Treatment Center, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Naysha N', 'Initials': 'NN', 'LastName': 'Shahid', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Howard', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa050']
423,31449956,Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans.,"BACKGROUND


The ""leave nothing behind"" strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans.
METHODS


Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n = 45) or DCB alone (n = 49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67 ± 10 years. The mean lesion length was 112 ± 64 mm.
RESULTS


There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P > 0.05). Flow-limiting dissections occurred more frequently in the DCB group (n = 12; 24.5%) than in the DA-DCB group (n = 2; 4.4%; P = 0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P = 0.006). The mean follow-up duration was 16.7 ± 6.1 months in the DCB group and 15.3 ± 5.8 months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P = 0.377).
CONCLUSIONS


In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified.",2020,Flow-limiting dissections occurred more frequently in the DCB group (n=12; 24.5%) than the DA-DCB group (n=2; 4.4%; P=0.006).,"['femoropopliteal arteriosclerosis obliterans', '94 patients were enrolled in our study with 72 males and the mean age was 67±10 years', 'Femoropopliteal Arteriosclerosis Obliterans', 'From June 2016 to June 2018 in our hospital, patients with femoropopliteal arteriosclerosis obliterans received endovascular therapy, they present with life-limiting claudication or severe chronic limb ischemia']","['directional atherectomy combined with drug-coated balloon angioplasty (n=45) or drug-coated balloon alone(n=49', 'Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty versus Drug-Coated Balloon Angioplasty', 'directional atherectomy combined with drug-coated balloon angioplasty', 'DCB', 'directional atherectomy combined with drug-coated balloon angioplasty with drug-coated balloon angioplasty alone']","['mean lesion length', 'overall mortality', 'technical success rate', 'flow-limiting dissection rate', 'Flow-limiting dissections', 'primary patency rate']","[{'cui': 'C0003851', 'cui_str': 'Arteriosclerosis Obliterans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}]","[{'cui': 'C0441488', 'cui_str': 'Directional atherectomy (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",94.0,0.0231949,Flow-limiting dissections occurred more frequently in the DCB group (n=12; 24.5%) than the DA-DCB group (n=2; 4.4%; P=0.006).,"[{'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lianrui', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhonggao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical University, Beijing, China. Electronic address: gu15901598209@aliyun.com.'}]",Annals of vascular surgery,['10.1016/j.avsg.2019.06.014']
424,31512148,"CardioMEMS, the real progress in heart failure home monitoring.","The burden of hospitalizations driven by exacerbation of acute heart failure remains unacceptably high. The associated use of hospital resources drives increasing patient, caregiver, and economic costs. Noninvasive telemedical systems investigated in randomized controlled trials have failed to demonstrate to reduce hospitalization rates probably because of the indirect (non-linear) relationship of the measured biological signals with the patient congestion status. Instead, there is increasing evidence that direct measure of intracardiac and pulmonary artery pressure can effectively guide heart failure management and reduce hospitalizations. Early studies adopting implantable hemodynamic monitors in the right heart unveiled the potential of pressure-based heart failure management, whereas subsequent investigations showed the powerful preemptive approach for heart failure exacerbations. One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management. The system monitoring safety and efficacy were also excellent. The study proved that early management in response to increased pulmonary pressure is able to provide the most effective therapeutic intervention to prevent heart failure exacerbations.",2020,One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management.,['subjects randomized to active pulmonary pressure-guided management'],['direct pulmonary pressure monitor system (CardioMEMS'],"['heart failure hospitalizations', 'hospitalization rates']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0182377', 'cui_str': 'Pressure monitor (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",,0.0433742,One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management.,"[{'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Gronda', 'Affiliation': ""Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano UOC di Nefrologia, Dialisi e Trapianto Renale dell'adulto Dipartimento Di Medicina e Specialità Mediche, Milan, Italy. edoardo.gronda@gmail.com.""}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Vanoli', 'Affiliation': 'Department of Molecular Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zorzi', 'Affiliation': 'Department of Cardiac Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Corrado', 'Affiliation': 'Department of Cardiac Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}]",Heart failure reviews,['10.1007/s10741-019-09840-y']
425,29785466,Effect of Reassuring Information About Musculoskeletal and Mental Health Complaints at the Workplace: A Cluster Randomized Trial of the atWork Intervention.,"Purpose The purpose of this study was to investigate the possible difference between the Modified atWork intervention (MAW) and the Original atWork intervention (OAW) on sick leave and other health related outcomes. atWork is a group intervention using the workplace as an arena for distribution of evidence-based knowledge about musculoskeletal and mental health complaints. Methods A cluster randomized controlled trial with 93 kindergartens, comprising a total of 1011 employees, was conducted. Kindergartens were stratified by county and size and randomly allocated to MAW (45 clusters, 324 respondents) or OAW (48 clusters, 313 respondents). The randomization and intervention allocation processes were concealed. There was no blinding to group allocation. Primary outcome was register data on sick leave at cluster level. Secondary outcomes were health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level. Results The MAW group reduced sick leave by 5.7% during the intervention year, while the OAW group had a 7.5% increase. Overall, the changes were not statistically significant, and no difference was detected between groups, based on 45 and 47 kindergartens. Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression. Conclusions The MAW did not have a different effect on sick leave at cluster level compared to the OAW. Trial registration https://Clinicaltrials.gov/ : NCT02396797. Registered March 23th, 2015.",2019,"Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression.","['93 kindergartens, comprising a total of 1011 employees, was conducted', 'Musculoskeletal and Mental Health Complaints at the Workplace']","['MAW', 'Modified atWork intervention (MAW) and the Original atWork intervention (OAW']","['register data on sick leave at cluster level', 'health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level', 'sick leave']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",1011.0,0.187325,"Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression.","[{'ForeName': 'Tone Langjordet', 'Initials': 'TL', 'LastName': 'Johnsen', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Vestfold Hospital Trust, POB 2168, 3103, Tønsberg, Norway. tone.johnsen@siv.no.'}, {'ForeName': 'Hege Randi', 'Initials': 'HR', 'LastName': 'Eriksen', 'Affiliation': 'Uni Research Health, POB 7810, 5020, Bergen, Norway.'}, {'ForeName': 'Valborg', 'Initials': 'V', 'LastName': 'Baste', 'Affiliation': 'Uni Research Health, POB 7810, 5020, Bergen, Norway.'}, {'ForeName': 'Aage', 'Initials': 'A', 'LastName': 'Indahl', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Vestfold Hospital Trust, POB 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Odeen', 'Affiliation': 'Uni Research Health, POB 7810, 5020, Bergen, Norway.'}, {'ForeName': 'Torill Helene', 'Initials': 'TH', 'LastName': 'Tveito', 'Affiliation': 'Uni Research Health, POB 7810, 5020, Bergen, Norway.'}]",Journal of occupational rehabilitation,['10.1007/s10926-018-9786-6']
426,29982957,The Development and Content of the Vocational Advice Intervention and Training Package for the Study of Work and Pain (SWAP) Trial (ISRCTN 52269669).,"Purpose There are substantial costs associated with sickness absence and struggling at work however existing services in the UK are largely restricted to those absent from work for greater than 6 months. This paper details the development of an early Vocational Advice Intervention (VAI) for adult primary care consulters who were struggling at work or absent due to musculoskeletal pain, and the structure and content of the training and mentoring package developed to equip the Vocational Advisors (VAs) to deliver the VAI, as part of the Study of Work and Pain (SWAP) cluster randomised trial. Methods In order to develop the intervention, we conducted a best-evidence literature review, summarised evidence from developmental studies and consulted with stakeholders. Results A novel early access, brief VAI was developed consisting of case management and stepped care (three steps), using the Psychosocial Flags Framework to identify and overcome obstacles associated with the health-work interface. Four healthcare practitioners were recruited to deliver the VAI; three physiotherapists and one nurse (all vocational advice was actually delivered by the three physiotherapists). They received training in the VA role during a 4-day course, with a refresher day 3 months later, along with monthly group mentoring sessions. Conclusions The process of development was sufficient to develop the VAI and associated training package. The evidence underpinning the VAI was drawn from an international perspective and key components of the VAI have the potential to be applied to other settings or countries, although this has yet to be tested.",2019,"This paper details the development of an early Vocational Advice Intervention (VAI) for adult primary care consulters who were struggling at work or absent due to musculoskeletal pain, and the structure and content of the training and mentoring package developed to equip the Vocational Advisors (VAs) to deliver the VAI, as part of the Study of Work and Pain (SWAP) cluster randomised trial.","['Four healthcare practitioners were recruited to deliver the VAI; three physiotherapists and one nurse (all vocational advice was actually delivered by the three physiotherapists', 'adult primary care consulters who were struggling at work or absent due to musculoskeletal pain']",['Vocational Advice Intervention (VAI'],[],"[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}]",[],[],,0.0337589,"This paper details the development of an early Vocational Advice Intervention (VAI) for adult primary care consulters who were struggling at work or absent due to musculoskeletal pain, and the structure and content of the training and mentoring package developed to equip the Vocational Advisors (VAs) to deliver the VAI, as part of the Study of Work and Pain (SWAP) cluster randomised trial.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sowden', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, ST5 5BG, UK. g.sowden@keele.ac.uk.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Main', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'van der Windt', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Burton', 'Affiliation': 'Centre for Applied Research in Health, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wynne-Jones', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}]",Journal of occupational rehabilitation,['10.1007/s10926-018-9799-1']
427,32404130,"Effect of mobile text messages on antiretroviral medication adherence and patient retention in early HIV care: an open-label, randomized, single center study in south Florida.","BACKGROUND


People with HIV (PHIV) with limited access to health services often experience suboptimal antiretroviral therapy (ART) adherence. We investigated whether a daily text messaging intervention improves ART adherence and retention in early HIV care in PHIV in a south Florida hospital-based clinic.
METHODS


ART-naïve PHIV receiving care through the clinic's Ryan White HIV/AIDS Program were enrolled and randomly assigned to the intervention or control groups with a 1:1 ratio. The intervention group received a 1-way text message daily and the control group received standard care without receiving text message reminders for 6 months. HIV RNA and CD4 cell count were measured at baseline and post-intervention. Adherence to ART was defined as a visual analog scale of ≥ 90%. Retention in care was defined as continued engagement at study end.
RESULTS


94 ART-naïve patients were randomized and 83 (85.6%) completed the study, of which 44 were in the intervention group and 39 were in the control group. At the end of the 6-month study period, adherence to ART was 84.4% in the intervention group versus 73.5% in the control group (OR, 1.9; 95% CI 0.7-5.0; p = 0.194). Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006). Undetectable HIV RNA (< 50 copies/mL) was 86.7% in the intervention group versus 73.5% in the control group (OR, 2.3; 95% CI 0.8-6.9; p = 0.112). A significant increase in CD4 cell count and a decrease in HIV RNA were found at study end, with no differences between the two groups.
CONCLUSIONS


In this pilot study, a one-way daily text messaging intervention did not improve ART adherence over a 6-month study period, but significantly enhanced patient retention in early HIV care. Implementation of interventions to improve adherence in this population is required.",2020,"Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006).","['south Florida', '94 ART-naïve patients', 'People with HIV (PHIV) with limited access to health services often experience suboptimal antiretroviral therapy (ART) adherence', ""ART-naïve PHIV receiving care through the clinic's Ryan White HIV/AIDS Program"", 'early HIV care in PHIV in a south Florida hospital-based clinic', 'early HIV care']","['1-way text message daily and the control group received standard care without receiving text message reminders', 'mobile text messages', 'daily text messaging intervention']","['adherence to ART', 'CD4 cell count', 'HIV RNA and CD4 cell count', 'HIV RNA', 'Undetectable HIV RNA', 'ART adherence and retention', 'antiretroviral medication adherence and patient retention', 'ART adherence', 'Retention in care']","[{'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}]",,0.124402,"Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006).","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Sherman', 'Affiliation': 'Department of Pharmacy Practice, Nova Southeastern University College of Pharmacy, 3200 South University Drive, Fort Lauderdale, FL, 33328, USA. esherman@nova.edu.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Office of Human Research, Memorial Healthcare System, 3111 Stirling Road, Hollywood, FL, 33312, USA.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Elrod', 'Affiliation': 'Department of Pharmacotherapy, University of North Texas System College of Pharmacy, 3500 Camp Bowie Boulevard, Fort Worth, TX, 76107, USA.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Clauson', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, One University Park Drive, Nashville, TN, 37204, USA.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Alkhateeb', 'Affiliation': 'Qatar University College of Pharmacy, QU Health, Building Ibn Al-Bitar (I06), Doha, Qatar.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Eckardt', 'Affiliation': 'Division of Infectious Diseases, Memorial Healthcare System, 5647 Hollywood Boulevard, Hollywood, FL, 33021, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00275-2']
428,32041897,Colocalized White Matter Plasticity and Increased Cerebral Blood Flow Mediate the Beneficial Effect of Cardiovascular Exercise on Long-Term Motor Learning.,"Cardiovascular exercise (CE) is a promising intervention strategy to facilitate cognition and motor learning in healthy and diseased populations of all ages. CE elevates humoral parameters, such as growth factors, and stimulates brain changes potentially relevant for learning and behavioral adaptations. However, the causal relationship between CE-induced brain changes and human's ability to learn remains unclear. We tested the hypothesis that CE elicits a positive effect on learning via alterations in brain structure (morphological changes of gray and white matter) and function (functional connectivity and cerebral blood flow in resting state). We conducted a randomized controlled trial with healthy male and female human participants to compare the effects of a 2 week CE intervention against a non-CE control group on subsequent learning of a challenging new motor task (dynamic balancing; DBT) over 6 consecutive weeks. We used multimodal neuroimaging [T1-weighted magnetic resonance imaging (MRI), diffusion-weighted MRI, perfusion-weighted MRI, and resting state functional MRI] to investigate the neural mechanisms mediating between CE and learning. As expected, subjects receiving CE subsequently learned the DBT at a higher rate. Using a modified nonparametric combination approach along with multiple mediator analysis, we show that this learning boost was conveyed by CE-induced increases in cerebral blood flow in frontal brain regions and changes in white matter microstructure in frontotemporal fiber tracts. Our study revealed neural mechanisms for the CE-learning link within the brain, probably allowing for a higher flexibility to adapt to highly novel environmental stimuli, such as learning a complex task. SIGNIFICANCE STATEMENT  It is established that cardiovascular exercise (CE) is an effective approach to promote learning and memory, yet little is known about the underlying neural transfer mechanisms through which CE acts on learning. We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a colocalized increase in cerebral blood flow. Our findings are among the first to demonstrate a transfer potential of experience-induced brain plasticity. In addition to practical implications for health professionals and coaches, our work paves the way for future studies investigating effects of CE in patients suffering from prefrontal hypoperfusion or white matter diseases.",2020,We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a co-localized increase in cerebral blood flow.,"['healthy and diseased populations of all ages', 'patients suffering from prefrontal hypoperfusion or white matter diseases', 'healthy, male and female human participants']","['CE intervention against a non-CE control group on subsequent learning of a challenging new motor task (dynamic balancing, DBT', 'Cardiovascular exercise (CE', 'Cardiovascular Exercise', 'CE', 'cardiovascular exercise (CE']","['learning via alterations in brain structure (morphological changes of gray and white matter) and function (functional connectivity and cerebral blood flow in resting state', 'cerebral blood flow', 'Cerebral Blood Flow Mediate']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion (qualifier value)'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0682708'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]",,0.0330105,We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a co-localized increase in cerebral blood flow.,"[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Lehmann', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany, nico1.lehmann@ovgu.de.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Villringer', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Taubert', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2310-19.2020']
429,32406112,Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis.,"BACKGROUND


Linaclotide, a guanylate cyclase C agonist relieves irritable bowel syndrome with predominant constipation (IBS-C) symptoms, but how it improves pain in humans is unknown.
AIMS


To investigate the effects of linaclotide and placebo on the afferent and efferent gut-brain-gut signalling in IBS-C patients, in a randomised clinical trial.
METHODS


Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations. Rectal sensations were examined by balloon distention. Assessments included abdominal pain, bowel symptoms and quality of life (QOL) scores. Primary outcomes were latencies of recto-cortical and cortico-rectal evoked potentials.
RESULTS


Thirty-nine patients participated; 26 received linaclotide and 13 received placebo. Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups. The efferent cortico-anorectal and spino-anorectal latencies were unchanged. The maximum tolerable rectal volume (cc) increased significantly with linaclotide compared to baseline (P < 0.001) and placebo (Δ 29 ± 10 vs 4 ± 20, (P < 0.03). Abdominal pain decreased (P < 0.001) with linaclotide but not between groups. Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo. There was no difference in overall responders between linaclotide and placebo (54% vs 23%, P = 0.13).
CONCLUSIONS


Linaclotide prolongs afferent gut-brain signalling from baseline but both afferent and efferent signalling were unaffected compared to placebo. Linaclotide significantly improves rectal hypersensitivity, IBS-C symptoms and QOL compared to placebo. These mechanisms may explain the effects of linaclotide on pain relief in IBS-C patients. ClinicalTrials.Gov: Registered at Clinical trials.gov no NCT02078323.",2020,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","['Thirty-nine patients participated; 26 received', 'IBS-C patients', 'Patients with IBS-C (Rome III) and rectal hypersensitivity']","['linaclotide', 'linaclotide (290\xa0µg) or placebo for 10\xa0weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations', 'Linaclotide', 'linaclotide vs placebo', 'linaclotide and placebo', 'placebo']","['abdominal pain, bowel symptoms and quality of life (QOL) scores', 'pain relief', 'overall responders', 'rectal hypersensitivity, IBS-C symptoms and QOL', 'Rectal sensations', 'latencies of recto-cortical and cortico-rectal evoked potentials', 'IBS-QOL scores', 'efferent cortico-anorectal and spino-anorectal latencies', 'Abdominal pain', 'Rectal cortical evoked potentials latencies (milliseconds', 'Complete spontaneous bowel movement frequency', 'maximum tolerable rectal volume (cc']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C2000261', 'cui_str': 'linaclotide'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232717', 'cui_str': 'Rectal sensation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205116', 'cui_str': 'Efferent'}, {'cui': 'C0439223', 'cui_str': 'ms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",39.0,0.636366,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Kulthep', 'Initials': 'K', 'LastName': 'Rattanakovit', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parr', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Ayyala', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15772']
430,30856112,Preliminary Report on the Feasibility and Efficacy of the Modified Atkins Diet for Treatment of Mild Cognitive Impairment and Early Alzheimer's Disease.,"Ketone bodies, the products of fat metabolism, are a source of energy for the brain and are available even when glucose supplies are inadequate (such as with severe carbohydrate deprivation) or its metabolism is faulty (as it is in Alzheimer's disease). This phase I/II randomized clinical trial examined the feasibility of using a modified Atkins diet (MAD) to induce ketogenesis in persons with mild cognitive impairment (MCI) or early AD, and the effect of this diet on memory and other clinical outcomes. In the first 2.5 years of active recruitment, only 27 eligible and willing patients enrolled. After extensive assessment and education, they and their study partners were randomly assigned for 12 weeks to either the MAD or the National Institute on Aging (NIA) recommended diet for seniors. As of April 2018, 9 patients in the MAD arm and 5 in the NIA arm have completed the trial. In spite of extensive teaching, coaching, and monitoring, adherence to both diets was only fair. Among those in the MAD arm who generated at least trace amounts of urinary ketones, there was a large (effect size = 0.53) and statistically significant (p = 0.03) increase in Memory Composite Score between the baseline and week-6 assessment. MAD participants also reported increased energy between baseline and week-6 assessment. Despite challenges to implementing this trial, resulting in a small sample, our preliminary data suggest that the generation of even trace ketones might enhance episodic memory and patient-reported vitality in very early AD.",2019,"Among those in the MAD arm who generated at least trace amounts of urinary ketones, there was a large (effect size = 0.53) and statistically significant (p = 0.03) increase in Memory Composite Score between the baseline and week-6 assessment.","[""Mild Cognitive Impairment and Early Alzheimer's Disease"", 'As of April 2018, 9 patients in the MAD arm and 5 in the NIA arm have completed the trial', 'persons with mild cognitive impairment (MCI) or early AD']","['modified Atkins diet (MAD', 'MAD or the National Institute on Aging (NIA) recommended diet for seniors', 'Modified Atkins Diet']","['urinary ketones', 'Memory Composite Score', 'Feasibility and Efficacy']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1955974', 'cui_str': 'National Institute on Aging'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C1955974', 'cui_str': 'National Institute on Aging'}]","[{'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0441969,"Among those in the MAD arm who generated at least trace amounts of urinary ketones, there was a large (effect size = 0.53) and statistically significant (p = 0.03) increase in Memory Composite Score between the baseline and week-6 assessment.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brandt', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Buchholz', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Henry-Barron', 'Affiliation': 'Institute for Clinical and Translational Research, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Vizthum', 'Affiliation': 'Institute for Clinical and Translational Research, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Avramopoulos', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mackenzie C', 'Initials': 'MC', 'LastName': 'Cervenka', 'Affiliation': 'Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180995']
431,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
432,31385108,Orthostatic heart rate does not predict symptomatic burden in pediatric patients with chronic orthostatic intolerance.,"PURPOSE


Postural orthostatic tachycardia syndrome (POTS) in adults is defined as symptoms of chronic orthostatic intolerance (COI) and autonomic dysfunction (AD) with heart rate (HR) increase of 30 beats per minute (bpm), or HR > 120 bpm, during prolonged upright position. However, in adolescents, POTS is defined as symptoms of OI and AD with HR increase of ≥ 40 bpm, based on tilt table data. We assessed frequency of COI symptoms in pediatric patients versus HR criteria on prolonged standing to evaluate using criteria of increased HR of 30-39 bpm versus ≥ 40 bpm in our POTS Program.
METHODS


Patients with COI with symptoms for > 3 months plus HR increase of ≥ 30 bpm on 10 min stand aged ≤ 18 years at diagnosis were included. Patients were divided into two groups: those with HR increase of 30-39 bpm, and those with HR increase of ≥ 40 bpm or upright HR of > 120 bpm. A total of 28 symptoms described prior to diagnosis were evaluated using chi-square testing to assess for significant differences.
RESULTS


Only insomnia was found to be significantly different between the two groups. The other 27 symptoms showed no significant difference as a function of HR.
CONCLUSION


There are minimal statistically significant differences and no clinical differences between patients as a function of HR increase during standing. Thus, a 40-bpm threshold for adolescents on standing test may be too high, or a specific HR criteria threshold is neither predictive nor definitive in diagnosing POTS.",2020,Only insomnia was found to be significantly different between the two groups.,"['Patients with COI with symptoms for ', '30\xa0bpm on 10 min stand aged ≤\u200918\xa0years at diagnosis were included', 'pediatric patients versus HR criteria', 'pediatric patients with chronic orthostatic intolerance']",[],"['function of HR', 'frequency of COI symptoms', 'symptoms of OI and AD with HR increase of ≥', 'chronic orthostatic intolerance (COI) and autonomic dysfunction (AD) with heart rate (HR', 'Orthostatic heart rate', 'HR increase of ≥']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}]",[],"[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0508817,Only insomnia was found to be significantly different between the two groups.,"[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Boris', 'Affiliation': ', Philadelphia, PA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bernadzikowski', 'Affiliation': ""Division of Radiology, The Children's Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA, 19104, USA. bernadzikt@email.chop.edu.""}]",Clinical autonomic research : official journal of the Clinical Autonomic Research Society,['10.1007/s10286-019-00622-y']
433,32057811,Randomized Trial of 2 Endoscopic Radial Artery Harvesting Devices-Immunofluorescence Assessment.,"BACKGROUND


Various devices are available for endoscopic radial artery harvesting during coronary artery bypass grafting. Thermal spread and graft damage, however, are common concerns. The aim of this study was to compare the MiFusion TLS2 system (Endotrust, Nettetal Germany) with direct heat technique and the LigaSure Maryland system (Medtronic, Dublin, Ireland) using advanced bipolar technique in a prospective randomized study.
METHODS


One hundred consecutive patients undergoing coronary artery bypass grafting with endoscopic radial artery harvesting were prospectively included and randomized 1:1. The proximal (brachial) ends of the grafts were analyzed using fluorescence microscopy with focus on graft integrity. In addition, harvesting time, graft sealing, residual bleeding, and incidence of neurological disorders were compared.
RESULTS


Patient age was 67 ± 8 years. Mean harvesting time was 26.5 ± 9 minutes for the TLS2 and 23.2 ± 8 minutes for the LigaSure (P = .049). Overall graft integrity was good in both groups. A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3 = best) with 2.5 ± 0.6 for TLS2 and 2.8 ± 0.4 for LigaSure (P = .031). LigaSure provided significantly better graft sealing (scale 0 to 2; 0 = best) with 0.6 ± 0.7 vs 1.0 ± 0.6 (TLS2) (P = .006) and less residual bleeding (scale 1 to 5; 1 = best) with 1.4 ± 0.6 vs 2.0 ± 0.9 (TLS2) (P < .001). Transient sensibility disorders were less frequently observed with LigaSure (2% vs 16%, P = .015).
CONCLUSIONS


Endoscopic radial artery harvesting can be performed with excellent results and good graft integrity using both devices. Compared with the MiFusion TLS2, the LigaSure device led to faster procedural times and resulted in better graft integrity. Along with providing a better seal, LigaSure was associated with less sensibility disorders.",2020,A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3=best) with 2.5±0.6 for TLS2™ and 2.8±0.4 for LigaSure (p=0.031).,"['Patient age was 67±8 years', '100 consecutive patients undergoing CABG with ERAH']","['MiFusion TLS2', 'MiFusion TLS2™ system (Endotrust, Germany) with direct heat technique and the LigaSure™ Maryland system (Medtronic, USA', 'endoscopic radial artery harvesting (ERAH', 'endoscopic radial artery harvesting devices - immunofluorescence assessment', 'coronary artery bypass grafting (CABG']","['Overall graft integrity', 'graft sealing', 'harvesting time, graft sealing, residual bleeding and incidence of neurological disorders', 'Mean harvesting time', 'Transient sensibility disorders', 'graft integrity', 'residual bleeding', 'sensibility disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0079603', 'cui_str': 'Immunofluorescence'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",100.0,0.0361679,A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3=best) with 2.5±0.6 for TLS2™ and 2.8±0.4 for LigaSure (p=0.031).,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Van Linden', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt. Electronic address: arnaud.vanlinden@kgu.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hecker', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Lehmann-Grube', 'Affiliation': 'Medical School, Justus Liebig University Giessen, Giessen.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Arsalan', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Richter', 'Affiliation': 'Department of Cardiac Surgery, Kerckhoff Clinic, Bad Nauheim, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Matzke', 'Affiliation': 'Max-Planck-Institute for Heart and Lung Research, Bad Nauheim, Germany.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Holubec', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.12.063']
434,32090517,Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial.,"OBJECTIVE


Previous studies have shown additive weight loss when intensive behavioral therapy (IBT) was combined with weight-loss medication. The present multisite study provides the first evaluation, in primary care, of the effect of the Centers for Medicare and Medicaid Services-based IBT benefit, delivered alone (with placebo) or in combination with liraglutide 3.0 mg.
METHODS


The Satiety and Clinical Adiposity-Liraglutide Evidence in individuals with and without diabetes (SCALE) IBT was a 56-week, randomized, double-blind, placebo-controlled, multicenter trial in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140) as an adjunct to IBT.
RESULTS


At week 56, mean weight loss with liraglutide 3.0 mg plus IBT was 7.5% and 4.0% with placebo combined with IBT (estimated treatment difference [95% CI]-3.4% [-5.3% to -1.6%], P = 0.0003). Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311). Liraglutide 3.0 mg in combination with IBT was well tolerated, with no new safety signals identified.
CONCLUSIONS


In a primary care setting, Centers for Medicare and Medicaid Services-based IBT produced clinically meaningful weight loss at 56 weeks, enhanced by the addition of liraglutide 3.0 mg.",2020,"Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311).","['Obesity in Primary Care', '3.0 mg (n\u2009=\u2009142) or', 'individuals with and without diabetes\xa0(SCALE', 'individuals with obesity who received']","['Liraglutide', 'liraglutide 3.0 mg', 'placebo', 'intensive behavioral therapy (IBT', 'IBT', 'liraglutide', 'liraglutide 3.0 mg plus IBT', 'Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT']","['weight loss', 'meaningful weight loss', 'Satiety and Clinical Adiposity-Liraglutide Evidence', 'mean weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0222045'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.247435,"Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311).","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Cedar Crosse Research Center, Chicago, Illinois, USA.'}, {'ForeName': 'Michael Taulo', 'Initials': 'MT', 'LastName': 'Lund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Auerbach', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22726']
435,32200994,High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation in critically ill patients with COVID-19 pneumonia: a prospective randomised controlled trial.,,2020,,['critically ill patients with COVID-19 pneumonia'],['High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation'],[],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'TS-COV19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",[],,0.33431,,"[{'ForeName': 'Cai-Neng', 'Initials': 'CN', 'LastName': 'Wu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Lin-Zhi', 'Initials': 'LZ', 'LastName': 'Xia', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Kun-Hong', 'Initials': 'KH', 'LastName': 'Li', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Wu-Hua', 'Initials': 'WH', 'LastName': 'Ma', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Dong-Nan', 'Initials': 'DN', 'LastName': 'Yu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bi-Xi', 'Initials': 'BX', 'LastName': 'Li', 'Affiliation': 'Wuhan, China. Electronic address: bxlee@sohu.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Guangzhou, China. Electronic address: yingcao1986@163.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.020']
436,32197805,"Effectiveness of video-based rehabilitation program on pain, functionality, and quality of life in the treatment of rotator cuff tears: A randomized controlled trial.","BACKGROUND


Video-based rehabilitation programs, which are also used in the treatment of neurological disorders, could be a beneficial treatment option for patients who cannot receive treatment.
PURPOSE


To determine the efficacy of video-based rehabilitation program in the conservative treatment of partial rotator cuff tears in comparison to a physiotherapist-supervised rehabilitation program.
STUDY DESIGN


A randomized controlled clinical trial.
METHODS


Thirty-three voluntary patients with partial rotator cuff tear were randomized into two groups: video-based rehabilitation (VBR) group and physiotherapist-supervised rehabilitation (PSR) group, for a common 6 weeks rehabilitation program. After drop outs, thirty participants (mean ± SD age, 50.60 ± 8.54 years; 10 female) were finally completed the trial. Active shoulder range of motion, pain, functional status, and health-related quality of life of the patients were assessed before and after treatment. Also, treatment satisfaction level was assessed at the end of the treatment.
RESULTS


There was statistically significant improvement in terms of active shoulder range of motion values (mean differences at 95% confidence interval for abduction: 30.75-51.37 in the VBR group, 34.20-54.45 in the PSR group, P = .001 in both groups) and secondary outcome measures within both groups (P < .05). However, there were no statistically significant differences in terms of all outcome measures between groups (P > .05). The level of satisfaction from treatment in the PSR group was higher than that in the VBR group.
CONCLUSION


A video-based rehabilitation program is an effective option in terms of shoulder range of motion, pain, functionality, and quality of life and has a comparable success level with a PSR program in the conservative treatment of partial rotator cuff tears.",2020,"There was statistically significant improvement in terms of active shoulder range of motion values (mean differences at 95% confidence interval for abduction: 30.75-51.37 in the VBR group, 34.20-54.45 in the PSR group, P = .001 in both groups) and secondary outcome measures within both groups (P < .05).","['partial rotator cuff tears', 'thirty participants (mean ± SD age, 50.60 ± 8.54 years; 10 female', 'rotator cuff tears', 'partial rotator cuff tears in comparison to a physiotherapist-supervised rehabilitation program', 'Thirty-three voluntary patients with partial rotator cuff tear', 'patients who cannot receive treatment']","['video-based rehabilitation program', 'video-based rehabilitation (VBR) group and physiotherapist-supervised rehabilitation (PSR) group, for a common 6 weeks rehabilitation program']","['active shoulder range of motion values', 'treatment satisfaction level', 'Active shoulder range of motion, pain, functional status, and health-related quality of life', 'pain, functionality, and quality of life', 'level of satisfaction']","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0580276', 'cui_str': 'Informal patient (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0575545', 'cui_str': 'Joint movement: shoulder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",33.0,0.0696901,"There was statistically significant improvement in terms of active shoulder range of motion values (mean differences at 95% confidence interval for abduction: 30.75-51.37 in the VBR group, 34.20-54.45 in the PSR group, P = .001 in both groups) and secondary outcome measures within both groups (P < .05).","[{'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Türkmen', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Institute of Graduate Education, Istanbul, Turkey. Electronic address: ezgi.turkmen.49@hotmail.com.'}, {'ForeName': 'Yıldız', 'Initials': 'Y', 'LastName': 'Analay Akbaba', 'Affiliation': 'Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Altun', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bakırkoy Dr. Sadi Konuk Education and Research Hospital, Istanbul, Turkey.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.08.004']
437,31995811,Nicotine dependence (trait) and acute nicotinic stimulation (state) modulate attention but not inhibitory control: converging fMRI evidence from Go-Nogo and Flanker tasks.,"Cognitive deficits during nicotine withdrawal may contribute to smoking relapse. However, interacting effects of chronic nicotine dependence and acute nicotine withdrawal on cognitive control are poorly understood. Here we examine the effects of nicotine dependence (trait; smokers (n = 24) vs. non-smoking controls; n = 20) and acute nicotinic stimulation (state; administration of nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning. We compared performance and neural responses between these four pharmacological manipulations in a double-blind, placebo-controlled crossover design. As expected, performance in both tasks was modulated by nicotine dependence, abstinence, and pharmacological manipulation. However, effects were driven entirely by conditions that required less inhibitory control. When demand for inhibitory control was high, abstinent smokers showed no deficits. By contrast, acutely abstinent smokers showed performance deficits in easier conditions and missed more trials. Go-Nogo fMRI results showed decreased inhibition-related neural activity in right anterior insula and right putamen in smokers and decreased dorsal anterior cingulate cortex activity on nicotine across groups. No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task. Given robust nicotinic effects on physiology and behavioral deficits in attention, we are confident that pharmacological manipulations were effective. Thus findings fit a recent proposal that abstinent smokers show decreased ability to divert cognitive resources at low or intermediate cognitive demand, while performance at high cognitive demand remains relatively unaffected, suggesting a primary attentional deficit during acute abstinence.",2020,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,['trait; smokers (n\u2009=\u200924) vs. non-smoking controls; n\u2009=\u200920) and acute nicotinic stimulation (state; administration of'],"['nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning', 'nicotine dependence', 'placebo', 'Nicotine dependence (trait) and acute nicotinic stimulation (state']","['dorsal anterior cingulate cortex activity', 'inhibition-related neural activity', 'performance deficits', 'Cognitive deficits', 'inhibition-related activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0240423,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lesage', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Sutherland', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Salmeron', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Estein@nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0623-1']
438,31664782,Itraconazole Increases Ibrutinib Exposure 10-Fold and Reduces Interindividual Variation-A Potentially Beneficial Drug-Drug Interaction.,"The oral bioavailability of ibrutinib is low and variable, mainly due to extensive first-pass metabolism by cytochrome P450 (CYP) 3A4. The unpredictable exposure can compromise its safe and effective dosing. We examined the impact of itraconazole on ibrutinib pharmacokinetics. In a randomized crossover study, 11 healthy subjects were administered itraconazole 200 mg or placebo twice on day 1, and once on days 2-4. On day 3, 1 hour after itraconazole (placebo) and breakfast, ibrutinib (140 mg during placebo; 15 mg during itraconazole) was administered. Itraconazole increased the dose-adjusted geometric mean area under the concentration-time curve from zero to infinity (AUC 0-∞  ) of ibrutinib 10.0-fold (90% confidence interval (CI) 7.2-13.9; P < 0.001) and peak plasma concentration (C max  ) 8.8-fold (90% CI 6.3-12.1; P < 0.001). During itraconazole, the intersubject variation for the AUC 0-∞  (55%) and C max  (53%) was around half of that during placebo (104%; 99%). In conclusion, itraconazole markedly increases ibrutinib bioavailability and decreases its interindividual variability, offering a possibility to improved dosing accuracy and cost savings.",2020,Itraconazole increased the dose-adjusted geometric mean AUC 0-∞  of ibrutinib 10.0-fold,['11 healthy subjects'],"['Itraconazole', 'itraconazole', 'itraconazole 200 mg or placebo', 'placebo', 'itraconazole (placebo) and breakfast, ibrutinib (140 mg during placebo']","['accuracy and cost savings', 'ibrutinib bioavailability and decreases its inter-individual variability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C3249440', 'cui_str': 'Itraconazole 200 MG [Onmel]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",11.0,0.133813,Itraconazole increased the dose-adjusted geometric mean AUC 0-∞  of ibrutinib 10.0-fold,"[{'ForeName': 'Tuija', 'Initials': 'T', 'LastName': 'Tapaninen', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Aleksi M', 'Initials': 'AM', 'LastName': 'Olkkola', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Tornio', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Neuvonen', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Elonen', 'Affiliation': 'Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Pertti J', 'Initials': 'PJ', 'LastName': 'Neuvonen', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Niemi', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Janne T', 'Initials': 'JT', 'LastName': 'Backman', 'Affiliation': 'Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Clinical and translational science,['10.1111/cts.12716']
439,31893513,Alcohol Abstinence in Drinkers with Atrial Fibrillation.,"BACKGROUND


Excessive alcohol consumption is associated with incident atrial fibrillation and adverse atrial remodeling; however, the effect of abstinence from alcohol on secondary prevention of atrial fibrillation is unclear.
METHODS


We conducted a multicenter, prospective, open-label, randomized, controlled trial at six hospitals in Australia. Adults who consumed 10 or more standard drinks (with 1 standard drink containing approximately 12 g of pure alcohol) per week and who had paroxysmal or persistent atrial fibrillation in sinus rhythm at baseline were randomly assigned in a 1:1 ratio to either abstain from alcohol or continue their usual alcohol consumption. The two primary end points were freedom from recurrence of atrial fibrillation (after a 2-week ""blanking period"") and total atrial fibrillation burden (proportion of time in atrial fibrillation) during 6 months of follow-up.
RESULTS


Of 140 patients who underwent randomization (85% men; mean [±SD] age, 62±9 years), 70 were assigned to the abstinence group and 70 to the control group. Patients in the abstinence group reduced their alcohol intake from 16.8±7.7 to 2.1±3.7 standard drinks per week (a reduction of 87.5%), and patients in the control group reduced their alcohol intake from 16.4±6.9 to 13.2±6.5 drinks per week (a reduction of 19.5%). After a 2-week blanking period, atrial fibrillation recurred in 37 of 70 patients (53%) in the abstinence group and in 51 of 70 patients (73%) in the control group. The abstinence group had a longer period before recurrence of atrial fibrillation than the control group (hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.84; P = 0.005). The atrial fibrillation burden over 6 months of follow-up was significantly lower in the abstinence group than in the control group (median percentage of time in atrial fibrillation, 0.5% [interquartile range, 0.0 to 3.0] vs. 1.2% [interquartile range, 0.0 to 10.3]; P = 0.01).
CONCLUSIONS


Abstinence from alcohol reduced arrhythmia recurrences in regular drinkers with atrial fibrillation. (Funded by the Government of Victoria Operational Infrastructure Support Program and others; Australian New Zealand Clinical Trials Registry number, ACTRN12616000256471.).",2020,"The atrial fibrillation burden over 6 months of follow-up was significantly lower in the abstinence group than in the control group (median percentage of time in atrial fibrillation, 0.5% [interquartile range, 0.0 to 3.0] vs. 1.2% [interquartile range, 0.0 to 10.3]; P = 0.01).
","['regular drinkers with atrial fibrillation', 'six hospitals in Australia', 'Drinkers with Atrial Fibrillation', '140 patients who underwent randomization (85% men; mean [±SD] age, 62±9 years', 'Adults who consumed 10 or more standard drinks (with 1 standard drink containing approximately 12 g of pure alcohol) per week and who had paroxysmal or persistent atrial fibrillation in sinus rhythm at baseline']","['Alcohol Abstinence', 'abstain from alcohol or continue their usual alcohol consumption']","['arrhythmia recurrences', 'alcohol intake', 'atrial fibrillation burden', 'total atrial fibrillation burden (proportion of time in atrial fibrillation', 'recurrence of atrial fibrillation', 'atrial fibrillation', 'freedom from recurrence of atrial fibrillation']","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}]","[{'cui': 'C0678274', 'cui_str': 'Abstinences, Alcohol'}, {'cui': 'C0854087', 'cui_str': 'Abstains from alcohol'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",140.0,0.0867473,"The atrial fibrillation burden over 6 months of follow-up was significantly lower in the abstinence group than in the control group (median percentage of time in atrial fibrillation, 0.5% [interquartile range, 0.0 to 3.0] vs. 1.2% [interquartile range, 0.0 to 10.3]; P = 0.01).
","[{'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Voskoboinik', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Kalman', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Anurika', 'Initials': 'A', 'LastName': 'De Silva', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nicholls', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Costello', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Nanayakkara', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Prabhu', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Dion', 'Initials': 'D', 'LastName': 'Stub', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Azzopardi', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Vizi', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Chrishan', 'Initials': 'C', 'LastName': 'Nalliah', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Sugumar', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Kotschet', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaye', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Taylor', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kistler', 'Affiliation': 'From the Heart Center, Alfred Hospital (A.V., T.N., B.C., S.N., S.P., D.S., S.A., D.V., H.S., D.K., A.J.T., P.M.K.), the Baker Heart and Diabetes Institute (A.V., B.C., S.P., D.S., H.S., A.J.T., P.M.K.), the Department of Cardiology, Royal Melbourne Hospital (A.V., J.M.K., S.P., G.W., C.N., H.S.), the Department of Medicine (A.V., J.M.K., P.M.K.) and the Centre for Epidemiology and Biostatistics (A.D.S.), University of Melbourne, the Department of Cardiology, Cabrini Hospital (P.M.K.), the Department of Cardiology, Western Health (D.S., M.W.), Monash Heart, Monash Medical Centre (E.K.), and the Department of Epidemiology and Preventive Medicine (D.S.) and Medicine (A.J.T.), Monash University - all in Melbourne, VIC, Australia.'}]",The New England journal of medicine,['10.1056/NEJMoa1817591']
440,31462727,"The effects of soursop supplementation on blood pressure, serum uric acid, and kidney function in a prehypertensive population in accordance with the 2017 ACC/AHA guideline.","Soursop consumption is beneficial to health, but there have been few clinical studies observing its benefit in human subjects. We investigated the effects of soursop supplementation on blood pressure (BP), serum uric acid (SUA), and kidney function. A total of 143 subjects were included in this randomized controlled trial. Subjects were selected from a prehypertension population dataset (n = 4190) in the ""Mlati Study Database"" in 2007 (using the Joint National Committee (JNC) 7 guideline). After 10 years, 143 samples showed essential prehypertension combined with high-normal SUA levels. Subjects were randomly allocated into two groups, i.e., the treatment and control group. For a 3-month period, the treatment group was given 2 × 100 g soursop fruit juice per day and the control group was not treated. Using the JNC 7 guideline, the treatment group showed a significantly lower mean systolic BP after being adjusted by three times of examinations (baseline, week 6 and 12) compared with the control group. Furthermore, the control group was more likely to have prehypertension, hypertension, and high-normal and high SUA levels after 6 weeks, as well as after 12 weeks, compared with the treatment group. An additional analysis using the 2017 ACC/AHA guideline for subjects with stage 1 hypertension showed results similar to that using the JNC 7 guideline. Moreover, it indicated that mean of both systolic and diastolic BP of the treatment group was significantly lower compared with the control group after 12 weeks of treatment. We conclude that soursop supplementation can lower BP and SUA levels.",2020,"Moreover, it indicated that mean of both systolic and diastolic BP of the treatment group was significantly lower compared with the control group after 12 weeks of treatment.","['human subjects', 'Subjects were selected from a prehypertension population dataset (n\u2009=\u20094190) in the ""Mlati Study Database"" in 2007 (using the Joint National Committee (JNC) 7 guideline', 'subjects with stage 1 hypertension', 'prehypertensive population in accordance with the 2017 ACC/AHA guideline', 'A total of 143 subjects']",['soursop supplementation'],"['blood pressure, serum uric acid, and kidney function', 'prehypertension, hypertension, and high-normal and high SUA levels', 'mean of both systolic and diastolic BP', 'blood pressure (BP), serum uric acid (SUA), and kidney function', 'mean systolic BP', 'BP and SUA levels', 'essential prehypertension combined with high-normal SUA levels']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}]","[{'cui': 'C3853347', 'cui_str': 'Annona muricata fruit'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",143.0,0.0182731,"Moreover, it indicated that mean of both systolic and diastolic BP of the treatment group was significantly lower compared with the control group after 12 weeks of treatment.","[{'ForeName': 'Haidar', 'Initials': 'H', 'LastName': 'Alatas', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Mochammad', 'Initials': 'M', 'LastName': ""Sja'bani"", 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia. msbani_jogja@yahoo.com.'}, {'ForeName': 'Mustofa', 'Initials': 'M', 'LastName': 'Mustofa', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Ali Ghufron', 'Initials': 'AG', 'LastName': 'Mukti', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Lucky A', 'Initials': 'LA', 'LastName': 'Bawazier', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Fredie', 'Initials': 'F', 'LastName': 'Irijanto', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Zulaela', 'Initials': 'Z', 'LastName': 'Zulaela', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Tomino', 'Affiliation': 'Medical Corporation SHOWAKAI, Tokyo, Japan.'}]",Journal of human hypertension,['10.1038/s41371-019-0235-6']
441,31463874,Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection.,"PURPOSE


The DNA fragmentation in sperm is associated with reduced outcome in assisted reproduction. Using YoPro1 as the staining dye and flow cytometry and sorting (FACS), the number of spermatozoa with DNA fragmentation can be lowered to 5%. Can the cumulative outcome of ICSI be improved using FACS?
METHODS


A prospective, randomized, double-blind clinical trial was conducted in 104 infertile couples with male infertility based on abnormal conventional semen analysis results. Cumulative ongoing pregnancy rate was the primary outcome parameter. In 52 cases, semen was processed for ICSI using swim-up. In another 52 cases, spermatozoa with fragmented DNA were removed with FACS.
RESULTS


The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up. An interim analysis scheduled before initiation of the study after 100 cases demonstrated that the aim of a 20% gain in pregnancy rate could not be achieved. For that reason, the prospective study was stopped prematurely.
CONCLUSIONS


A trend towards consistently better results was achieved by removing spermatozoa with fragmented DNA. The fragmentation of the DNA in sperm is the end stage of apoptosis. Sorting of spermatozoa may be improved by selecting parameters of processes active more upstream of apoptosis, such as chromatin decondensation.
TRIAL REGISTRATION


NCT02166567 . June 14, 2014.",2019,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,['104 infertile couples with male infertility based on abnormal conventional semen analysis results'],[],"['Cumulative ongoing pregnancy rate', 'pregnancy rate', 'cumulative pregnancy rate', 'live birth rate', 'miscarriage rate']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021364', 'cui_str': 'Male infertility (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",,0.368995,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'De Geyter', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland. christian.degeyter@usb.ch.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Gobrecht-Keller', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ahler', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-019-01571-1']
442,31664766,"A Double-Blind, Phase I, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BOS161721 in Healthy Subjects.","The purpose of this study was to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BOS161721, a humanized immunoglobulin G1 triple mutation (M252Y/S254T/T256E) monoclonal antibody that inhibits interleukin-21 (IL-21) bioactivity. This randomized, single-center, double-blind, placebo-controlled study randomized healthy volunteers 3:1 to single ascending intravenous and subcutaneous doses of BOS161721 (range 1-240 mg) or placebo. BOS161721 and placebo groups had similar rates of adverse events, mostly mild; none led to study discontinuation. There were no clinically significant findings in physical examination, vital signs, or laboratory assessment. In the pooled BOS161721 population, four subjects (8.5%) tested antidrug antibody-positive predose, and seven (14.9%) postdose. Absolute CD4+ lymphocyte count remained normal throughout follow-up. BOS161721 administered subcutaneously was absorbed slowly, with a median time to maximum concentration (T max  ) of 144 hours across doses (range 1-15 days) and a mean apparent terminal elimination half-life of 80-87 days for doses ≥ 30 mg. Area under the concentration-time curve from time zero to infinity (AUC 0-inf  ) and maximum observed concentration (C max  ) were linear across doses > 10 mg. Subcutaneous bioavailability was 64%. Phosphorylated signal transducer and activator of transcription 3 (pSTAT3) decreased dose-dependently with threshold characteristics at doses of ≥ 10 mg. Downregulation in BATF, IL6, LAG3, and SOCS3 genes caused by IL-21 stimulation was reversed dose-dependently. BOS161721 was well-tolerated across doses, suppressed IL-21-induced pSTAT3 dose-dependently, and reversed downregulation of genes critical to tolerance induction and T-cell exhaustion induced by IL-21. Further clinical studies are ongoing in patients with systemic lupus erythematosus, in which IL-21 has a pathogenetic role.",2020,"BOS161721 was well tolerated across doses, suppressed IL-21-induced pSTAT3 dose-dependently, and reversed downregulation of genes critical to tolerance induction and T-cell exhaustion induced by IL-21.","['healthy subjects', 'patients with systemic lupus erythematosus']","['humanized immunoglobulin G1 (IgG1) triple mutation (YTE) (M252Y/S254T/T256E) monoclonal antibody', 'placebo', 'BOS161721']","['physical examination, vital signs, or laboratory assessment', 'downregulation of genes critical to tolerance induction and T-cell exhaustion', 'Absolute CD4+ lymphocyte count', 'safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BOS161721', 'safety, pharmacokinetics and pharmacodynamics', 'Subcutaneous bioavailability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}]","[{'cui': 'C0020855', 'cui_str': 'IgG1'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0518766'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.382796,"BOS161721 was well tolerated across doses, suppressed IL-21-induced pSTAT3 dose-dependently, and reversed downregulation of genes critical to tolerance induction and T-cell exhaustion induced by IL-21.","[{'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hussaini', 'Affiliation': 'PAREXEL International Corporation, Waltham, Massachusetts, USA.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Mukherjee', 'Affiliation': 'Cytel, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Dina M', 'Initials': 'DM', 'LastName': 'Berdieva', 'Affiliation': 'Boston Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Christen', 'Initials': 'C', 'LastName': 'Glogowski', 'Affiliation': 'Boston Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mountfield', 'Affiliation': 'Boston Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Peter T C', 'Initials': 'PTC', 'LastName': 'Ho', 'Affiliation': 'Boston Pharmaceuticals, Cambridge, Massachusetts, USA.'}]",Clinical and translational science,['10.1111/cts.12715']
443,31642607,"Lack of Detection of the Analgesic Properties of PF-05089771, a Selective Na v  1.7 Inhibitor, Using a Battery of Pain Models in Healthy Subjects.","Sodium channel blockers are used for the treatment of pain, but this is limited by the lack of selectivity for different sodium channel subtypes, which can result in central nervous system and cardiovascular side effects. As such, there is special interest in the Na v  1.7 subtype, which is expressed predominantly in nociceptive and sympathetic neurons. The aim was to demonstrate analgesic properties of a potent selective Na v  1.7 sodium channel blocker, PF-05089771, alone and concomitantly with pregabalin in healthy subjects using a battery of human evoked pain models. This was a double-blind, double-dummy, randomized, placebo-controlled, five-period cross-over study with PF-05089771 alone and PF-05089771 concomitantly with pregabalin as treatment arms with pregabalin, ibuprofen, and placebo as control arms (NCT02349607). A battery of human evoked pain models was used to investigate analgesic properties of PF-05089771. Twenty-five subjects were enrolled in the study of which 23 subjects completed all five periods. PF-05089771 alone did not differ from placebo on the primary pain end points. The same holds when comparing PF-05089771 concomitantly with pregabalin and pregabalin alone. Pregabalin showed significant effects relative to placebo on thermal pain on the normal skin and UVB skin (least squares means with 90% confidence interval: 0.63 (0.32-0.93) and 0.53 (0.11-0.96)), pressure stimulation (1.10 (1.04-1.18)), and cold pressor (1.22 (1.14-1.32)). Ibuprofen demonstrated significant effects on thermal pain UVB skin (1.26 (0.82-1.70)) and pressure stimulation assessment (1.08 (1.01-1.15)), consistent with historical results. This study did not demonstrate analgesic properties of PF-05089771 alone or concomitantly with pregabalin in a battery of pain models.",2020,"Ibuprofen demonstrated significant effects on thermal pain UVB skin (1.26(0.82-1.70)) and pressure stimulation assessment (1.08(1.01-1.15)), consistent with historical results.","['25 subjects were enrolled in the study of which 23 subjects completed all 5 periods', 'healthy subjects using a battery of human evoked pain models', 'healthy subjects']","['pregabalin', 'pregabalin and pregabalin', 'pregabalin, ibuprofen and placebo', 'potent selective Na v  1.7 sodium channel blocker, PF-05089771, alone and concomitantly with pregabalin', 'placebo', 'Pregabalin', 'Sodium channel blockers', 'Ibuprofen']","['thermal pain on the normal skin and UVB skin', 'thermal pain UVB skin', 'pressure stimulation', 'cold pressor', 'pressure stimulation assessment']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0872271', 'cui_str': 'Sodium Channel Inhibitors'}, {'cui': 'C4506758', 'cui_str': 'PF-05089771'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0037492', 'cui_str': 'Ion Channels, Sodium'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",23.0,0.129412,"Ibuprofen demonstrated significant effects on thermal pain UVB skin (1.26(0.82-1.70)) and pressure stimulation assessment (1.08(1.01-1.15)), consistent with historical results.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Siebenga', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'van Amerongen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Hay', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Aoibhinn', 'Initials': 'A', 'LastName': 'McDonnell', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': 'Gorman', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Butt', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Clinical and translational science,['10.1111/cts.12712']
444,26813209,Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial.,"IMPORTANCE


Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring.
OBJECTIVE


To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood.
DESIGN, SETTING, AND PARTICIPANTS


The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks' gestation. Five participants were deemed ineligible shortly after randomization and were discontinued.
INTERVENTIONS


Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D.
MAIN OUTCOMES AND MEASURES


Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels.
RESULTS


Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%-47.5%, P < .001).
CONCLUSIONS AND RELEVANCE


In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00920621.",2016,"Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051).","['Four hundred forty women', 'Asthma or Recurrent Wheezing in Offspring by Age 3 Years', 'Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma', 'pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of', '3 centers across the United States', ' and 436 women', 'Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes', 'The Vitamin D Antenatal Asthma Reduction Trial']","['prenatal vitamin D (cholecalciferol) supplementation', 'placebo', 'daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D', 'placebo plus a prenatal vitamin containing 400 IU vitamin D', 'vitamin D', 'Prenatal Supplementation With Vitamin D']","['vitamin D levels', 'incidence of asthma and recurrent wheezing', 'asthma or recurrent wheeze', 'blood levels', '25-hydroxyvitamin D levels', 'Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4517778', 'cui_str': '4400 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0005768'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",440.0,0.743499,"Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051).","[{'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Harshfield', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'McElrath', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts3Department of Obstetrics and Gynecology, Brigham & Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Sandel', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Iverson', 'Affiliation': 'Department of Obstetrics and Gynecology, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Lee-Paritz', 'Affiliation': 'Department of Obstetrics and Gynecology, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Strunk', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri8St Louis Children's Hospital, St Louis, Missouri.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri8St Louis Children's Hospital, St Louis, Missouri.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Kaiser Permanente Southern California, San Diego, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schatz', 'Affiliation': 'Kaiser Permanente Southern California, San Diego, California.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Hornsby', 'Affiliation': ""King's College London School of Medicine, Asthma, Allergy and Respiratory Science, Guy's Hospital Campus, London, United Kingdom.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hawrylowicz', 'Affiliation': ""King's College London School of Medicine, Asthma, Allergy and Respiratory Science, Guy's Hospital Campus, London, United Kingdom.""}, {'ForeName': 'Ann Chen', 'Initials': 'AC', 'LastName': 'Wu', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts13Department of Population Medicine, Harvard Pilgrim Health Care Institute and Children's Hospital Boston, Boston, Massachusetts.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2015.18589']
445,31895002,"Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).","PURPOSE


PLUS investigated the efficacy and safety of mirabegron add-on therapy in men with overactive bladder symptoms receiving tamsulosin for underlying lower urinary tract symptoms attributable to benign prostatic hyperplasia.
MATERIALS AND METHODS


In this phase 4 study a 4-week 0.4 mg tamsulosin run-in period was followed by a 12-week, randomized, double-blind, treatment period in which patients initially received 25 mg mirabegron or placebo add-on therapy. At 4 weeks doses were titrated to 50 mg mirabegron or placebo equivalent. Efficacy end points were changes from baseline to end of treatment in mean number of micturitions per day (primary), mean volume voided per micturition, number of urgency episodes per day, total urgency and frequency score, and total International Prostate Symptom Score (secondary). Safety assessments included treatment emergent adverse events, and post-void residual volume, and maximum urinary flow measurements.
RESULTS


Of the 676 men most were 65 years old or older (380, 56.2%). Tamsulosin plus mirabegron was statistically superior to tamsulosin plus placebo in reducing the mean number of micturitions per day (-2.00 vs -1.62; adjusted difference -0.39; 95% CI -0.76, -0.02). Statistically superior results were noted for tamsulosin plus mirabegron in mean volume voided per micturition, urgency episodes per day, and total urgency and frequency score (not International Prostate Symptom Score). Higher overall treatment emergent adverse event rates were observed with tamsulosin plus placebo, although higher rates of drug related treatment emergent adverse events were noted with tamsulosin plus mirabegron. Urinary retention rates were higher in the tamsulosin plus mirabegron group. Post-void residual volume and maximum urinary flow results were not clinically meaningful.
CONCLUSIONS


The results of PLUS underscore the utility of mirabegron add-on therapy to treat men with overactive bladder symptoms receiving tamsulosin for benign prostatic hyperplasia.",2020,"Statistically superior results were noted for TAM+MIRA in MVV/micturition, urgency episodes/day, and TUFS (not IPSS).","['Of 676 men, most were ≥65 years old (380 [56.2%] patients', 'men with OAB symptoms receiving', 'men with overactive bladder (OAB) symptoms receiving tamsulosin for underlying lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH', 'Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia']","['tamsulosin', 'TAM+PL', 'TAM+MIRA', 'mirabegron 25 mg or placebo', 'tamsulosin plus placebo (TAM+PL', 'mirabegron 50 mg or placebo', 'Tamsulosin plus mirabegron (TAM+MIRA', 'Mirabegron versus Placebo']","['TAM+MIRA in MVV/micturition, urgency episodes/day, and TUFS (not IPSS', 'mean number of micturitions/day (primary), mean volume voided (MVV)/micturition, number of urgency episodes/day, Total Urgency and Frequency Score (TUFS), and total International Prostate Symptom Score (IPSS; secondary', 'efficacy and safety', 'PVR volume and Q max', 'Higher overall TEAE rates', 'Efficacy and Safety', 'Urinary retention rates', 'post-void residual (PVR) volume and maximum urinary flow (Q max ) assessments']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C3474323', 'cui_str': 'mirabegron 25 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0024967', 'cui_str': 'MVV (Ventilation)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997470', 'cui_str': 'Total international prostate symptom score'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",676.0,0.178298,"Statistically superior results were noted for TAM+MIRA in MVV/micturition, urgency episodes/day, and TUFS (not IPSS).","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, New York.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': ""Division of Urology, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Foley', 'Affiliation': 'Department of Urology, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cambronero Santos', 'Affiliation': 'Department of Urology, Infanta Leonor Hospital, Madrid, Spain.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Astellas Pharma Global Development Inc., Northbrook, Illinois.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Astellas Pharma Europe Ltd., Chertsey, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hairston', 'Affiliation': 'Astellas Pharma Global Development Inc., Northbrook, Illinois.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Schermer', 'Affiliation': 'Astellas Pharma Global Development Inc., Northbrook, Illinois.'}]",The Journal of urology,['10.1097/JU.0000000000000738']
446,30241706,Home Environment-Focused Intervention Improves Dietary Quality: A Secondary Analysis From the Healthy Homes/Healthy Families Randomized Trial.,"OBJECTIVE


Estimate Healthy Homes/Healthy Families (HHHF) intervention efficacy for improving dietary quality.
METHODS


Low-income overweight and obese women (n = 349) recruited from rural community health centers were randomized to receive HHHF, a 16-week home environment-focused coaching intervention or health education materials by mail. Healthy Eating Index-2010 scores were calculated from 2 24-hour dietary recalls collected at baseline and 6- and 12-month follow-up.
RESULTS


HHHF participants reported greater improvements in Healthy Eating Index-2010 total scores at 6-month follow-up (+3.41 ± 13.43 intervention vs +2.02 ± 12.26 control; P =.009). Subcomponent analysis indicated greater consumption of total vegetables (P = .02) and greens and beans (P = .001), whole grains (P = .02) and reduced consumption of empty calories (P = .03). Standardized intervention effect sizes were 0.16 at 6 months and 0.13 at 12 months of follow-up.
CONCLUSIONS AND IMPLICATIONS


The HHHF resulted in short-term improvements in dietary quality, although more research is needed to interpret the clinical significance of effect sizes of this magnitude.",2019,"Subcomponent analysis indicated greater consumption of total vegetables (P = .02) and greens and beans (P = .001), whole grains (P = .02) and reduced consumption of empty calories (P = .03).","['Low-income overweight and obese women (n\u202f=\u202f349) recruited from rural community health centers', 'Healthy Homes/Healthy Families (HHHF']","['HHHF, a 16-week home environment-focused coaching intervention or health education materials by mail', 'Home Environment-Focused Intervention']","['reduced consumption of empty calories', 'Dietary Quality', 'consumption of total vegetables', 'Healthy Eating Index-2010 total scores', 'dietary quality', 'Healthy Eating Index-2010 scores']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0018701'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",349.0,0.0791087,"Subcomponent analysis indicated greater consumption of total vegetables (P = .02) and greens and beans (P = .001), whole grains (P = .02) and reduced consumption of empty calories (P = .03).","[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Woodruff', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA. Electronic address: rwoodr2@emory.edu.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Haardörfer', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Gazmararian', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Ballard', 'Affiliation': 'Horizons Community Solutions, Inc., Albany, GA.'}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Addison', 'Affiliation': 'Primary Care of Southwest Georgia, Inc., Blakely, GA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Hotz', 'Affiliation': 'Albany Area Primary Health Care, Albany, GA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Tucker', 'Affiliation': 'South Central Primary Care Center, Inc., Ocilla, GA.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Kegler', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.06.007']
447,31145214,"Onset of action of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: results from 2 randomized, placebo-controlled, phase 3 trials.","Opioid-induced constipation (OIC) is a common side effect of chronic opioid therapy. Previously, naldemedine, a peripherally acting μ-opioid receptor antagonist demonstrated efficacy in the treatment of OIC. In this exploratory analysis, the onset of action of naldemedine was evaluated in 2 identically designed phase 3, randomized, placebo-controlled trials. Proportion of patients experiencing a spontaneous bowel movement (SBM) within 24 hours of treatment initiation, time from initial dose to first SBM and weekly SBM frequency were assessed. Naldemedine was associated with significant increases in the proportion of patients experiencing an SBM at 4, 8, 12, and 24 hours after the initial dose compared with placebo (all P < 0.0001). Within 24 hours in both studies, statistically significantly (P < 0.0001) more patients treated with naldemedine compared with placebo experienced an SBM (61.2% vs 28.3% and 56.5% vs 33.6%, respectively). Median times to first SBM were significantly shorter in the naldemedine group vs placebo (COMPOSE-1, 16.1 vs 46.7 hours; COMPOSE-2, 18.3 vs 45.9 hours; P < 0.0001). Naldemedine was also associated with significant increases in weekly SBM frequency vs placebo within 1 week (P < 0.001). Most common treatment-emergent adverse events were gastrointestinal-related (abdominal pain, diarrhea, and nausea). Treatment-emergent adverse events were reported most frequently on day 1, followed by a decrease from days 2 to 7. Naldemedine had a timely onset of effect, and gastrointestinal adverse events largely resolved within the first week. These findings should assist clinicians counseling patients with chronic noncancer pain on expectations when initiating naldemedine for OIC.",2019,"Within 24 hours in both studies, statistically significantly (P<0.0001) more patients treated with naldemedine compared with placebo experienced an SBM (61.2% vs. 28.3% and 56.5% vs. 33.6%, respectively).",['patients with chronic noncancer pain'],"['placebo', 'NCT01993940This', 'Opioid-induced constipation (OIC', 'placebocontrolled', 'Naldemedine', 'naldemedine']","['Median times to first SBM', 'proportion of patients experiencing an SBM', 'SBM', 'weekly SBM frequency', 'spontaneous bowel movement (SBM', 'gastrointestinal-related (abdominal pain, diarrhea, and nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3160897'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.106407,"Within 24 hours in both studies, statistically significantly (P<0.0001) more patients treated with naldemedine compared with placebo experienced an SBM (61.2% vs. 28.3% and 56.5% vs. 33.6%, respectively).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wild', 'Affiliation': 'Upstate Clinical Research Associates, Williamsville, NY, United States.'}, {'ForeName': 'Tadaaki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Shionogi, Inc., Florham Park, NJ, United States.'}, {'ForeName': 'Juan Camilo', 'Initials': 'JC', 'LastName': 'Arjona Ferreira', 'Affiliation': 'Shionogi, Inc., Florham Park, NJ, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hale', 'Affiliation': 'Gold Coast Research, LLC, Plantation, FL, United States.'}]",Pain,['10.1097/j.pain.0000000000001629']
448,31980512,Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.,"INTRODUCTION


Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).
METHODS AND ANALYSES


Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice.
ETHICS AND DISSEMINATION


The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women.
TRIAL REGISTRATION NUMBER


NCT03334149.",2020,"Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).
","['2262 pregnant women', '512 pregnant women with either gestational or chronic hypertension']","['BP self-monitoring', 'Self-monitoring of blood pressure (BP', 'telemonitoring or usual care', 'BUMP', 'Blood pressure monitoring']","['time to the first recording of raised BP by a healthcare professional', 'systolic BP', 'mean systolic BP', 'maternal and perinatal outcomes, quality of life and adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2262.0,0.18161,"Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).
","[{'ForeName': 'Greig', 'Initials': 'G', 'LastName': 'Dougall', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Franssen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katherine Louise', 'Initials': 'KL', 'LastName': 'Tucker', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hinton', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Abel', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca Jane', 'Initials': 'RJ', 'LastName': 'Band', 'Affiliation': 'Academic Unit of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Chisholm', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Crawford', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'Action on Pre-eclampsia, Evesham, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Greenfield', 'Affiliation': 'Primary Care Clinical Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hodgkinson', 'Affiliation': 'Primary Care Clinical Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leeson', 'Affiliation': 'Cardiovascular Clinical Research Facility, Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCourt', 'Affiliation': 'Centre for Maternal & Child Health Research, School of Health Sciences, City University, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'MacKillop', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, Oxford University Hospitals NHS Trust, Oxford, UK.""}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, Kings College, London, London, UK.""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wilson', 'Affiliation': ""Department of Women and Children's Health, Kings College, London, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Academic Unit of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, Kings College, London, London, UK lucy.chappell@kcl.ac.uk.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034593']
449,32065827,Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial.,"Importance


Intraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated.
Objective


To test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension.
Design, Setting, and Participants


Preliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute.
Interventions


Patients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups.
Main Outcomes and Measures


The primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).
Results


Among 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
Conclusions and Relevance


In this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT03376347.",2020,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","['adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019', 'During Elective Noncardiac Surgery', '68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women', 'patients undergoing elective noncardiac surgery']","['early warning system (n\u2009=\u200934) or standard care', 'Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care', 'machine learning-derived early warning system compared with standard care']","['median time of hypotension', 'mean arterial pressure (MAP', 'intraoperative hypotension', 'time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury', 'median length of surgery', 'Hypotension', 'median time-weighted average of hypotension', '0 serious adverse events resulting in death', 'morbidity and mortality', 'Depth and Duration of Intraoperative Hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1270999', 'cui_str': 'Invasive blood pressure (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517362', 'cui_str': 'Hypotension during surgery (disorder)'}, {'cui': 'C1519795', 'cui_str': 'Unit of measure (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",68.0,0.308548,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Wijnberge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart F', 'Initials': 'BF', 'LastName': 'Geerts', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Hol', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Lemmers', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Marijn P', 'Initials': 'MP', 'LastName': 'Mulder', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Schenk', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Lotte E', 'Initials': 'LE', 'LastName': 'Terwindt', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Veelo', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}]",JAMA,['10.1001/jama.2020.0592']
450,31445091,Percutaneous Venous Angioplasty in Patients with Multiple Sclerosis and Chronic Cerebrospinal Venous Insufficiency: A Randomized Wait List Control Study.,"BACKGROUND


Venous percutaneous transluminal angioplasty (vPTA) in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI) have shown contradictory results. The aim of the study is to evaluate the efficacy of the procedure in a randomized wait list control study.
METHODS


66 adults with neurologist-confirmed diagnosis of MS and sonographic diagnosis of CCSVI were allocated into vPTA-yes group (n = 31) or vPTA-not group (n = 35, control group). vPTA was performed immediately 15 days after randomization in the PTA-yes group and 6 months later in the control group. Evoked potentials (EPs), clinical-functional measures (CFMs), and upper limb kinematic measures (ULKMs) were measured at baseline (T0) and six months after in both groups, just before the venous angioplasty in the vPTA-not group (T1).
RESULTS


Comparing the vPTA-yes and vPTA-not group, the CFM-derived composite functional outcome showed 11 (37%) versus 7 (20%) improved, 1 (3%) versus 3 (8%) stable, 0 versus 7 (20%) worsened, and 19 (61%) versus 18 (51%) mixed patients (χ 2  = 8.71, df = 3, P = 0.03). Unadjusted and adjusted (for baseline confounding variables) odds ratio at 95% confidence interval were, respectively, 1.93 (1.3-2.8), P value 0.0007, and 1.85 (1.2-1.7), P value 0.002. EP- and ULKM-derived composite functional outcome showed no significant difference between the two groups.
CONCLUSIONS


Venous angioplasty can positively impact a few CFMs especially for the quality of life but achieving disability improvement is unlikely.",2020,"1.93(1.3-2.8) P-value 0.0007 and 1.85(1.2-1.7) P-value 0.002. EPs and ULKM derived composite functional outcome showed no significant difference between the two groups.
","['66 adults with neurologist-confirmed diagnosis of MS and sonographic diagnosis of CCSVI', 'Patients With Multiple Sclerosis And Chronic Cerebrospinal Venous Insufficiency', 'patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI']","['vPTA-yes group (n=31) or vPTA-not group', 'percutaneous transluminal angioplasty (vPTA', 'Percutaneous Venous Angioplasty']","['Evoked potentials (EPs), clinical-functional measures (CFM) and upper limb kinematic measures (ULKM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237426', 'cui_str': 'Neurologists'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C4511608', 'cui_str': 'CCSVI - chronic cerebrospinal venous insufficiency'}]","[{'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0455750', 'cui_str': 'Angioplasty of vein (procedure)'}]","[{'cui': 'C0015214', 'cui_str': 'Evoked Potentials'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",66.0,0.0521447,"1.93(1.3-2.8) P-value 0.0007 and 1.85(1.2-1.7) P-value 0.002. EPs and ULKM derived composite functional outcome showed no significant difference between the two groups.
","[{'ForeName': 'Vinicio', 'Initials': 'V', 'LastName': 'Napoli', 'Affiliation': 'Unit of Diagnostic and Interventional Radiology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Berchiolli', 'Affiliation': 'Unit of Vascular Surgery, Department of Traslational Research and New Technologies in Medicine and Surgery, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Carboncini', 'Affiliation': 'Section of Severe Acquired Brain Injuries, Department of Traslational Research and New Technologies in Medicine and Surgery, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Sartucci', 'Affiliation': 'Section of Neurology, Department of Clinical and Experimental Medicine, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Marconi', 'Affiliation': 'Unit of Vascular Surgery, Department of Traslational Research and New Technologies in Medicine and Surgery, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. Electronic address: michemarconi@gmail.com.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Bocci', 'Affiliation': 'Section of Neurology, Department of Clinical and Experimental Medicine, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Orsola', 'Initials': 'O', 'LastName': 'Perrone', 'Affiliation': 'Unit of Diagnostic and Interventional Radiology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mannoni', 'Affiliation': 'Section of Neurology, Department of Clinical and Experimental Medicine, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Congestrì', 'Affiliation': 'Section of Neurology, Department of Clinical and Experimental Medicine, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Benedetti', 'Affiliation': 'Section of Severe Acquired Brain Injuries, Department of Traslational Research and New Technologies in Medicine and Surgery, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Morganti', 'Affiliation': 'Statistic Unit, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Caramella', 'Affiliation': 'Unit of Diagnostic Radiology, Department of Traslational Research and New Technologies in Medicine and Surgery, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cioni', 'Affiliation': 'Unit of Diagnostic and Interventional Radiology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Unit of Vascular Surgery, Department of Traslational Research and New Technologies in Medicine and Surgery, University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}]",Annals of vascular surgery,['10.1016/j.avsg.2019.05.018']
451,31764363,"The Effects of Perioperative Corticosteroids on Dysphagia Following Surgical Procedures Involving the Anterior Cervical Spine: A Prospective, Randomized, Controlled, Double-Blinded Clinical Trial.","BACKGROUND


Dysphagia is one of the most common complications of surgical procedures in the anterior cervical spine, and can persist up to 2 years postoperatively. Corticosteroids are relatively safe and inexpensive for treating various inflammatory conditions. Perioperative corticosteroid administration for anterior cervical spine procedures may effectively minimize postoperative dysphagia, potentially leading to better outcomes, decreased readmission rates, and improved patient satisfaction. The purpose of this study was to determine the efficacy of perioperative corticosteroids in decreasing the severity and duration of dysphagia following single-level and multilevel anterior cervical spine procedures.
METHODS


Seventy-four patients undergoing elective anterior cervical surgical procedures for degenerative conditions were recruited. Patients with prior cervical procedures; with a diagnosis of fracture, malignancy, or infection; or requiring combined anterior-posterior procedures were excluded. Patients were randomized to perioperative intravenous dexamethasone or saline solution. Doses were administered before incision and at 8 and 16 hours postoperatively. Investigators and patients were blinded to the treatment throughout the study. Dysphagia outcomes were assessed with use of the Bazaz dysphagia scale and the Dysphagia Short Questionnaire (DSQ) at 1 day, 2 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months postoperatively. Statistical analysis was performed comparing means and standard deviations; significance was set at p < 0.05. Clinical outcomes were measured with use of the Quality of Life-12 and Neck Disability Index.
RESULTS


Sixty-four patients were included in the analysis. There were 49 anterior cervical discectomies and fusions, 8 corpectomies, 1 hybrid procedure (corpectomy and adjacent discectomy), and 6 single-level arthroplasties. Patients who received corticosteroids had significantly better dysphagia scores on both the Bazaz scale and DSQ at most time points up to 6 months postoperatively (p < 0.05). On subgroup analysis, patients with multilevel (≥2-level) fusion benefited significantly from corticosteroids on both scales, whereas those with single-level procedures did not. There were no short-term wound complications or infections, and length of stay and fusion rates were comparable.
CONCLUSIONS


Perioperative administration of corticosteroids can reduce dysphagia symptoms following multilevel anterior cervical procedures. Benefit was noted immediately and up to 6 months postoperatively. There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
","['Dysphagia Following Surgical Procedures Involving the Anterior Cervical Spine', 'Seventy-four patients undergoing elective anterior cervical surgical procedures for degenerative conditions were recruited', 'multilevel anterior cervical procedures', 'Patients with prior cervical procedures; with a diagnosis of fracture, malignancy, or infection; or requiring combined anterior-posterior procedures were excluded', 'Sixty-four patients were included in the analysis']","['Perioperative Corticosteroids', 'corticosteroids', 'Corticosteroids', 'perioperative intravenous dexamethasone or saline solution', 'perioperative corticosteroids']","['Quality of Life-12 and Neck Disability Index', 'dysphagia scores', 'dysphagia symptoms', 'Dysphagia outcomes', 'Bazaz dysphagia scale and the Dysphagia Short Questionnaire (DSQ', 'Bazaz scale and DSQ', 'short-term wound-healing, infection rates, length of stay, or fusion rates', 'short-term wound complications or infections, and length of stay and fusion rates', 'readmission rates']","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0034380'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",49.0,0.0837887,"There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
","[{'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Daffner', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'France', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Sanford E', 'Initials': 'SE', 'LastName': 'Emery', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00198']
452,31350540,Acute Blood Pressure and Cardiovascular Effects of Near-Roadway Exposures With and Without N95 Respirators.,"BACKGROUND


The risk for cardiovascular events increases within hours of near-roadway exposures. We aimed to determine the traffic-related air pollution (TRAP) and biological mechanisms involved and if reducing particulate matter <2.5 µm (PM2.5) inhalation is protective.
METHODS


Fifty healthy-adults underwent multiple 2-hour near-roadway exposures (Tuesdays to Fridays) in Ann Arbor during 2 separate weeks (randomized to wear an N95 respirator during 1 week). Monday both weeks, participants rested 2 hours in an exam room (once wearing an N95 respirator). Brachial blood pressure, aortic hemodynamics, and heart rate variability were repeatedly measured during exposures. Endothelial function (reactive hyperemia index [RHI]) was measured post-exposures (Thursdays). Black carbon (BC), total particle count (PC), PM2.5, noise and temperature were measured throughout exposures.
RESULTS


PM2.5 (9.3 ± 7.7 µg/m3), BC (1.3 ± 0.6 µg/m3), PC (8,375 ± 4,930 particles/cm3) and noise (69.2 ± 4.2 dB) were higher (P values <0.01) and aortic hemodynamic parameters trended worse while near-roadway (P values<0.15 vs. exam room). Other outcomes were unchanged. Aortic hemodynamics trended towards improvements with N95 respirator usage while near-roadway (P values<0.15 vs. no-use), whereas other outcomes remained unaffected. Higher near-roadway PC and BC exposures were associated with increases in aortic augmentation pressures (P values<0.05) and trends toward lower RHI (P values <0.2). N95 respirator usage did not mitigate these adverse responses (nonsignificant pollutant-respirator interactions). Near-roadway outdoor-temperature and noise were also associated with cardiovascular changes.
CONCLUSIONS


Exposure to real-world combustion-derived particulates in TRAP, even at relatively low concentrations, acutely worsened aortic hemodynamics. Our mixed findings regarding the health benefits of wearing N95 respirators support that further studies are needed to validate if they adequately protect against TRAP given their growing worldwide usage.",2019,"Aortic hemodynamics trended towards improvements with N95-respirator usage while near-roadway (p-values<0.15 versus no-use), whereas other outcomes remained unaffected.",['Fifty healthy-adults underwent multiple 2-hour near-roadway exposures (Tuesdays-Fridays) in Ann Arbor during 2 separate weeks (randomized to wear an N95-respirator during one week'],['particulate matter<2.5 µm (PM2.5) inhalation'],"['Endothelial function (reactive hyperemia index [RHI', 'adverse responses', 'Brachial blood pressure, aortic hemodynamics and heart rate variability', 'Aortic hemodynamics', 'aortic hemodynamic parameters', 'Acute Blood Pressure and Cardiovascular Effects', 'Black carbon (BC), total particle count (PC), PM2.5, noise and temperature', 'aortic augmentation pressures']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0042497', 'cui_str': 'Respirators'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0457784', 'cui_str': 'Particulate (finding)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",50.0,0.0598782,"Aortic hemodynamics trended towards improvements with N95-respirator usage while near-roadway (p-values<0.15 versus no-use), whereas other outcomes remained unaffected.","[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Morishita', 'Affiliation': 'Department of Family Medicine, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Speth', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Bard', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Fengyao', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Family Medicine, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Brook', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Rajagopalan', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve Medical School, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",American journal of hypertension,['10.1093/ajh/hpz113']
453,31584739,"Safety, Tolerability, and Pharmacokinetics of the Mineralocorticoid Receptor Modulator AZD9977 in Healthy Men: A Phase I Multiple Ascending Dose Study.","Excessive activation of the mineralocorticoid receptor (MR) underlies the pathophysiology of heart failure and chronic kidney disease. Hyperkalemia risk limits the therapeutic use of conventional MR antagonists. AZD9977 is a nonsteroidal, selective MR modulator that may protect nonepithelial tissues without disturbing electrolyte balance. This phase I study investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of AZD9977 in healthy volunteers. Twenty-seven male participants aged 23-45 years were randomized 3:1 to receive oral AZD9977 or placebo for 8 days (with twice-daily dosing on days 2-7), in dose cohorts of 50, 150, and 300 mg (AZD9977, n = 6 per cohort; placebo, n = 3 per cohort). Adverse events occurred in 4 of 18 participants receiving AZD9977 (22.2%) and 6 of 9 receiving placebo (66.7%), all of mild or moderate severity; none were serious or led to withdrawal. AZD9977 was rapidly absorbed, with median time of maximum concentration of 0.50-0.84 hours across dose groups. Area under the curve and maximum concentration were approximately dose proportional but elimination and accumulation terminal half-life increased with dose. Steady-state was reached after 3-4 days, with dose-dependent accumulation of 1.2-1.7-fold. Renal clearance was 5.9-6.5 L/hour and 24-37% of AZD9977 was excreted in the urine. Serum aldosterone levels increased dose dependently from days -1 to 7 in participants receiving AZD9977, but serum potassium levels and urinary electrolyte excretion were unchanged. AZD9977 was generally well-tolerated with no safety concerns. Exploratory outcomes suggested reduced hyperkalemia risk compared with MR antagonists. These findings support further clinical development of AZD9977.",2020,"AZD9977 was rapidly absorbed, with median t max  of 0.50-0.84 hours across dose groups.","['Twenty-seven male participants aged 23-45 years', 'Healthy Men', 'healthy volunteers']","['AZD9977', 'mineralocorticoid receptor antagonists', 'oral AZD9977 or placebo', 'conventional mineralocorticoid receptor antagonists', 'placebo', 'Mineralocorticoid Receptor Modulator AZD9977']","['Serum aldosterone levels', 'hyperkalemia risk', 'Adverse events', 'serum potassium levels and urinary electrolyte excretion', 'Steady state', 'Safety, Tolerability, and Pharmacokinetics', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'Renal clearance']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4705855', 'cui_str': 'AZD9977'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}]","[{'cui': 'C0428395', 'cui_str': 'Aldosterone measurement, serum (procedure)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}]",27.0,0.0924517,"AZD9977 was rapidly absorbed, with median t max  of 0.50-0.84 hours across dose groups.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whittaker', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Åsa M', 'Initials': 'ÅM', 'LastName': 'Kragh', 'Affiliation': 'Clinical Pharmacology, ADME and AI, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hartleib-Geschwindner', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Early Phase Clinical Unit, PAREXEL, Harrow, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Backlund', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Heijer', 'Affiliation': 'Clinical Pharmacology Biologics and Bioanalysis, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Early Biometrics and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Forte', 'Affiliation': 'Early Phase Clinical Unit, PAREXEL, Harrow, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Unwin', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wernevik', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ericsson', 'Affiliation': 'Clinical Pharmacology, ADME and AI, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Clinical and translational science,['10.1111/cts.12705']
454,32175985,Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia in renal transplantation: A randomised trial.,"BACKGROUND


Several studies have shown an analgesic efficacy of a transversus abdominis plane block (TAPB) in reducing opioid requirements during and after cadaveric renal transplantation surgery, but the effect of a quadratus lumborum block (QLB) in this type of surgery is unclear.
OBJECTIVES


The main objective of this prospective, randomised, double-centre clinical study was to compare the analgesic efficacy of a one-sided lateral approach TAPB with a unilateral QLB type 2 in cadaveric renal transplantation surgery.
DESIGN


Randomised, single-blinded trial.
SETTING


Two University-affiliated tertiary care hospitals between April 2016 and May 2017.
PATIENTS


A total of 101 patients aged more than 18 years, scheduled for cadaveric renal transplantation.
INTERVENTIONS


On receiving ethical board approval and individual informed consent, consecutive patients were allocated randomly to receive either an ultrasound-guided single-shot lateral TAPB or an ultrasound-guided single-shot QLB type 2 on the surgical side using 20 ml of bupivacaine 0.25% with adrenaline after a standardised induction of general anaesthesia. All patients on surgical completion and recovery from general anaesthesia were admitted to the postanaesthesia care unit for 24 h. They received standardised intravenous patient-controlled analgesia with fentanyl, and their pain scores were noted at regular intervals.
MAIN OUTCOME MEASURES


The primary endpoint was total cumulative fentanyl dose used per kg body mass in the first 24 h after surgery. Secondary outcomes were the need to start a continuous infusion of fentanyl in addition to patient-controlled analgesia boluses during the stay in post-anaesthesia care unit, postoperative pain severity measured using a numerical rating scale, patient satisfaction with analgesic treatment, evidence of postoperative nausea and vomiting, pruritus and sedation level.
RESULTS


The 49 patients allocated to the QLB type 2 group used significantly less fentanyl per kg in the first 24 h after surgery than the 52 patients who received a TAPB (median [IQR] 4.2 [2.3 to 8.0] μg kg versus 6.7 [3.5 to 10.7] μg kg, P = 0.042). No statistically significant differences were noted in the secondary endpoints within the study, including the frequency of adverse effects of opioids.
CONCLUSION


The reduction of fentanyl consumption in the first 24 h after renal transplantation with no difference in pain intensity and patient satisfaction shows a beneficial effect of one-sided QLB type 2 over a one-sided TAPB in regards to postoperative analgesia. However, the reduction in opioid consumption did not affect the frequency of opioid-related adverse effects.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT02783586.",2020,The reduction of fentanyl consumption in the first 24 h after renal transplantation with no difference in pain intensity and patient satisfaction shows a beneficial effect of one-sided QLB type 2 over a one-sided TAPB in regards to postoperative analgesia.,"['All patients on surgical completion and recovery from general anaesthesia were admitted to the postanaesthesia care unit for 24\u200ah', 'renal transplantation', 'cadaveric renal transplantation surgery', 'Two University-affiliated tertiary care hospitals between April 2016 and May 2017', 'A total of 101 patients aged more than 18 years, scheduled for cadaveric renal transplantation']","['standardised intravenous patient-controlled analgesia with fentanyl', 'TAPB', 'transversus abdominis plane block (TAPB', 'ultrasound-guided single-shot lateral TAPB or an ultrasound-guided single-shot QLB type 2 on the surgical side using 20\u200aml of bupivacaine 0.25% with adrenaline', 'Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia']","['reduction of fentanyl consumption', 'need to start a continuous infusion of fentanyl in addition to patient-controlled analgesia boluses during the stay in post-anaesthesia care unit, postoperative pain severity measured using a numerical rating scale, patient satisfaction with analgesic treatment, evidence of postoperative nausea and vomiting, pruritus and sedation level', 'pain scores', 'analgesic efficacy', 'opioid consumption', 'frequency of adverse effects of opioids', 'total cumulative fentanyl dose used per kg body mass', 'pain intensity and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0167914', 'cui_str': 'TAPB-H'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",101.0,0.286278,The reduction of fentanyl consumption in the first 24 h after renal transplantation with no difference in pain intensity and patient satisfaction shows a beneficial effect of one-sided QLB type 2 over a one-sided TAPB in regards to postoperative analgesia.,"[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kolacz', 'Affiliation': 'From the I Department of Anesthesiology and Intensive Care, Medical University of Warsaw, Warsaw (MK, MJ, KZ, BB, JT) and Department of Anesthesiology and Intensive Care, Collegium Medicum, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland (MM, MW-D, DO).'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Mieszkowski', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Janiak', 'Affiliation': ''}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zagorski', 'Affiliation': ''}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Byszewska', 'Affiliation': ''}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Weryk-Dysko', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Onichimowski', 'Affiliation': ''}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Trzebicki', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001193']
455,31654487,"Safety, Tolerability, Pharmacokinetics, Target Occupancy, and Concentration-QT Analysis of the Novel BTK Inhibitor Evobrutinib in Healthy Volunteers.","Bruton's tyrosine kinase (BTK) is a key regulator of B cell receptor and Fc receptor signaling, and a rational therapeutic target for autoimmune diseases. This first-in-human phase I, double-blind, placebo-controlled trial investigated the safety, tolerability, pharmacokinetics (PK), target occupancy, and effects on QT interval of evobrutinib, a highly selective, oral inhibitor of BTK, in healthy subjects. This dose escalation trial consisted of two parts. Part 1 included 48 subjects in 6 ascending dose cohorts (25, 50, 100, 200, 350, and 500 mg) randomized to a single dose of evobrutinib or placebo. Part 2 included 36 subjects in 3 ascending dose cohorts (25, 75, and 200 mg/day) randomized to evobrutinib or placebo once daily for 14 days. Safety and tolerability, as well as PK and target occupancy (total and free BTK in peripheral blood mononuclear cells), were assessed following single and multiple dosing. PK parameters were determined by noncompartmental methods. QT interval was obtained from 12-lead electrocardiogram recordings and corrected for heart rate by Fridericia's method (QTcF). Treatment-emergent adverse events (TEAEs) were mostly mild, occurring in 25% of subjects after single dosing, and 48.1% after multiple dosing. There was no apparent dose relationship regarding frequency or type of TEAE among evobrutinib-treated subjects. Absorption was rapid (time to reach maximum plasma concentration (T max  ) ~ 0.5 hour), half-life short (~ 2 hours), and PK dose-proportional, with no accumulation or time dependency on repeat dosing. BTK occupancy was dose-dependent, reaching maximum occupancy of > 90% within ~ 4 hours after single doses ≥ 200 mg; the effect was long-lasting (> 50% occupancy at 96 hours with ≥ 100 mg). After multiple dosing, full BTK occupancy was achieved with 25 mg, indicating slow turnover of BTK protein in vivo. Concentration-QTcF analyses did not show any impact of evobrutinib concentration on corrected QT (QTc). In summary, evobrutinib was well-tolerated, showed linear and time-independent PK, induced long-lasting BTK inhibition, and was associated with no prolongation of QT/QTc interval in healthy subjects. Evobrutinib is, therefore, suitable for investigation in autoimmune diseases.",2020,"Absorption was rapid (t max  ~0.5 h), half-life short (t ½  ~2 h), and PK dose-proportional, with no accumulation or time dependency on repeat dosing.","['Healthy Volunteers', 'healthy subjects']","['placebo', 'evobrutinib or placebo']","['safety, tolerability, pharmacokinetics (PK), target occupancy, and effects on QT interval of evobrutinib', 'QT interval', 'PK and target occupancy (total and free BTK in peripheral blood mononuclear cells', 'PK parameters', 'Safety, Tolerability, Pharmacokinetics, Target Occupancy, and Concentration-QT Analysis of the Novel BTK Inhibitor Evobrutinib', 'prolongation of QT/QTc interval', 'Safety and tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",48.0,0.156144,"Absorption was rapid (t max  ~0.5 h), half-life short (t ½  ~2 h), and PK dose-proportional, with no accumulation or time dependency on repeat dosing.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Becker', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Martin', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Mitchell', 'Affiliation': 'Nuventra Pharma Sciences, Broomfield, Colorado, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Grenningloh', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Bender', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Laurent', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Mackenzie', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Johne', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}]",Clinical and translational science,['10.1111/cts.12713']
456,31549356,"Effect of Obesity on Asthma Severity in Urban School Children of Kanpur, India: An Analytical Cross-Sectional Study.","The prevalence of both Obesity and Asthma is increasing worldwide. Various epidemiological data has linked obesity with the development and severity of asthma in children. The aim of this study was to assess if any relationship exists between obesity and asthma in children. The study population included school children aged 5 to 18 years. A total of 320 asthma cases and 300 controls were included in our study. Association analysis of obesity and asthma based on epidemiological basis was measured. Out of 320 cases, 61 children were found to have moderate persistent asthma. Out of 61 moderate persistent asthma cases, 50 children were selected randomly and divided into two groups. Group I included 25 obese moderate persistent asthmatics and Group II included 25 non-obese moderate persistent asthmatics. Forced expiratory volume in one second (FEV 1 ), Forced vital capacity (FVC), Forced expiratory flow (FEF 25-75% ), Peak expiratory flow (PEF) were measured with spirometry and Peak expiratory flow meter. Statistical analysis was done by Odds ratio and p value. Out of 320 cases, 97 were obese and 223 were non-obese. Out of 300 controls, 46 were obese and 254 were non-obese. Exposure rate for cases and controls were 30.31% and 15.33% respectively. Odds ratio was 2.40. χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant. Children who are obese are more likely to develop severe asthma than those who were not obese.",2020,"χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant.","['Out of 320 cases, 61 children were found to have moderate persistent asthma', 'Out of 320 cases, 97 were obese and 223 were non-obese', 'Out of 300 controls, 46 were obese and 254 were non-obese', 'children', '25 obese moderate persistent asthmatics and Group II included 25 non-obese moderate persistent asthmatics', 'school children aged 5 to 18\xa0years', '320 asthma cases and 300 controls were included in our study', '61 moderate persistent asthma cases, 50 children', 'Urban School Children of Kanpur, India']",[],"['spirometry and Peak expiratory flow meter', 'Forced expiratory volume in one second (FEV 1 ), Forced vital capacity (FVC), Forced expiratory flow (FEF 25-75% ), Peak expiratory flow (PEF', 'Exposure rate']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960047', 'cui_str': 'Moderate persistent asthma (disorder)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",61.0,0.0334171,"χ 2  value was 19.56 with p value < 0.05.FEV 1 , FVC, FEF 25-75%, PEF  for Group-1 were 66.3 ± 9.9, 63.5 ± 4.2, 54.2 ± 5.7, 67.4 ± 8.4 respectively and FEV 1 , FVC, FEF 25-75% , PEF for Group-2 were 74.07 ± 3.5, 77.4 ± 7.2, 60.1 ± 2.1, 71.6 ± 2.4 respectively and p values were < 0.001, < 0.001, < 0.001, < 0.05 respectively which is statistically significant.","[{'ForeName': 'S P Senthil', 'Initials': 'SPS', 'LastName': 'Kumar', 'Affiliation': 'Columbia Asia Hospital, Whitefield, Bengaluru, Karnataka, India. drsenthilsp@yahoo.co.in.'}, {'ForeName': 'Shalu', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Femiint Health Care, Whitefield, Bengaluru, Karnataka, India.'}]",Journal of community health,['10.1007/s10900-019-00749-z']
457,30609152,"Is risperidone effective in reducing challenging behaviours in individuals with intellectual disabilities after 1 year or longer use? A placebo-controlled, randomised, double-blind discontinuation study.","BACKGROUND


Many people with intellectual disabilities use risperidone long term for the management of challenging behaviours, despite its limited proof of effectiveness and its clear association with adverse events. Therefore, this study aimed to investigate the effectiveness of ongoing treatment with risperidone in reducing challenging behaviours versus controlled discontinuation on behaviour and health parameters.
METHOD


This was a placebo-controlled, double-blind, randomised discontinuation trial of risperidone. In the discontinuation group, risperidone was gradually replaced by a placebo over 14 weeks, while the control group maintained their existing dosage. Eight weeks after discontinuation, behaviour (as measured by the 'Aberrant Behavior Checklist') and health parameters (dyskinesia, akathisia, parkinsonism, weight, waist circumference, sedation and laboratory outcomes) were compared in both groups.
RESULTS


A total of 25 participants were included in the trial, of which 11 were randomised into the discontinuation group and 14 were randomised into the continued treatment group. In the discontinuation group, 82% completely withdrew from risperidone. There was no significant change in irritability, compared with the continuation group, although there was a Group*Time effects on stereotypical behaviour in favour of the continuation group. Significant Group*Time effects were also found for weight, waist, body mass index, prolactin levels and testosterone levels, with beneficial effects for the discontinuation group.
CONCLUSION


Discontinuation of long-term risperidone for reducing challenging behaviours is possible, without an increase in irritability. Discontinuation of risperidone may have beneficial effects on weight, waist circumference, prolactin levels and testosterone levels. The study suffered from difficulties in achieving the required sample size, which affected study power and generalizability.",2019,"Significant Group*Time effects were also found for weight, waist, body mass index, prolactin levels and testosterone levels, with beneficial effects for the discontinuation group.
","['A total of 25 participants', 'individuals with intellectual disabilities after 1\xa0year or longer use']","['risperidone', 'placebo']","['weight, waist circumference, prolactin levels and testosterone levels', 'stereotypical behaviour', ""Aberrant Behavior Checklist') and health parameters (dyskinesia, akathisia, parkinsonism, weight, waist circumference, sedation and laboratory outcomes"", 'weight, waist, body mass index, prolactin levels and testosterone levels', 'irritability']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}]",25.0,0.12525,"Significant Group*Time effects were also found for weight, waist, body mass index, prolactin levels and testosterone levels, with beneficial effects for the discontinuation group.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ramerman', 'Affiliation': 'Centre for Intellectual Disability and Mental Health, GGZ Drenthe, Assen, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'de Kuijper', 'Affiliation': 'Centre for Intellectual Disability and Mental Health, GGZ Drenthe, Assen, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Scheers', 'Affiliation': 'Accare Child and Adolescent Psychiatry, Groningen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vink', 'Affiliation': 'Cosis, Assen, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vrijmoeth', 'Affiliation': 'De Baalderborg Groep, Hardenberg, The Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12584']
458,32171061,"MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial.","BACKGROUND


Treatment of multiple myeloma is not curative, but targeting CD38 improves patient survival. To further explore this therapeutic approach, we investigated the safety and activity of MOR202, a novel monoclonal antibody targeting CD38, in patients with multiple myeloma.
METHODS


This is a multicentre, open-label, phase 1-2a trial done at ten hospitals in Germany and Austria. Enrolled patients were aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w [twice a week] and q1w [weekly] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity. The primary analysis was assessed in the safety population, which included patients who received at least one dose of any study drug. This trial is registered with ClinicalTrials.gov, NCT01421186.
FINDINGS


Between Aug 24, 2011, and Aug 1, 2017, 91 patients were treated, 35 with MOR202 monotherapy, and 56 with MOR202 combination regimens (18 in the MOR202 with dexamethasone group, 21 in the MOR202 with dexamethasone plus pomalidomide group, and 17 in the MOR202 with dexamethasone plus lenalidomide group). MOR202 intravenous infusions were safely administered within 30 min. Infusion-related reactions occurred in 14 (40%) of 35 patients receiving MOR202 monotherapy without steroids, and in four (7%) of 56 patients receiving MOR202 combination treatment. MOR202 maximum tolerated dose was not reached and the recommended regimens were MOR202 administered as an intravenous infusion for 30 min at doses up to 16 mg/kg with dexamethasone (40 mg), or in combination with dexamethasone plus lenalidomide (25 mg) or pomalidomide (4 mg). 35 (38%) of 91 patients developed lymphopenia, 30 (33%) developed neutropenia, and 27 (30%) developed leukopenia; these were the most common grade 3 or higher treatment-emergent adverse events. Serious adverse events were reported in 51 (56%) of 91 patients. None of the deaths were associated with MOR202. One pomalidomide-associated death occurred in the MOR202 with dexamethasone plus pomalidomide group. No anti-MOR202 antibodies were detected in patients.
INTERPRETATION


MOR202 is safe and its clinical activity in patients with relapsed or refractory multiple myeloma is promising. Further clinical investigations of combinations with an immunomodulatory drug and dexamethasone are recommended.
FUNDING


MorphoSys AG.",2020,Serious adverse events were reported in 51 (56%) of 91 patients.,"['91 patients were treated, 35 with MOR202 monotherapy, and 56 with MOR202 combination regimens (18 in the MOR202 with dexamethasone group, 21 in the MOR202 with', 'Between Aug 24, 2011, and Aug 1, 2017', 'ten hospitals in Germany and Austria', 'patients with relapsed or refractory multiple myeloma', 'patients with multiple myeloma', 'Enrolled patients were aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher']","['MOR202 q2w [twice a week] and q1w [weekly] groups) or in combination with dexamethasone (MOR202 with dexamethasone', 'MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3\u2008+\u20083 design', 'dexamethasone plus lenalidomide', 'MOR202 intravenous infusions alone', 'dexamethasone', 'dexamethasone plus lenalidomide (25 mg) or pomalidomide', 'MOR202', 'dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide', 'dexamethasone plus pomalidomide']","['No anti-MOR202 antibodies', 'Serious adverse events', 'neutropenia', 'safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity', 'death', 'lymphopenia', 'leukopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",91.0,0.152029,Serious adverse events were reported in 51 (56%) of 91 patients.,"[{'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany. Electronic address: marc.raab@med.uni-heidelberg.de.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Hematology and Oncology Department, Medical University Hospital, Freiburg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blank', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany; National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Hermine', 'Initials': 'H', 'LastName': 'Agis', 'Affiliation': 'Department of Medicine I, University Hospital of Internal Medicine -Allgemeines Krankenhaus Wien, Vienna, Austria.'}, {'ForeName': 'Igor W', 'Initials': 'IW', 'LastName': 'Blau', 'Affiliation': 'Department of Internal Medicine III, Charité Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Einsele', 'Affiliation': 'Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ferstl', 'Affiliation': 'Department of Internal Medicine 5, Hematology and Oncology, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Schub', 'Affiliation': 'Department of Medicine, University Hospital Schleswig-Holstein, Division of Stem Cell Transplantation and Immunotherapy, Kiel, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Röllig', 'Affiliation': 'Department of Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg; Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Winderlich', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Griese', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Härtle', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Weirather', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Tiantom', 'Initials': 'T', 'LastName': 'Jarutat', 'Affiliation': 'MorphoSys AG, Planegg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Peschel', 'Affiliation': 'Department of Internal Medicine III, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Manik', 'Initials': 'M', 'LastName': 'Chatterjee', 'Affiliation': 'Translational Oncology, Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg, Würzburg, Germany.'}]",The Lancet. Haematology,['10.1016/S2352-3026(19)30249-2']
459,32199095,"Safety and efficacy of rituximab in neuromyelitis optica spectrum disorders (RIN-1 study): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND


Pharmacological prevention against relapses in patients with neuromyelitis optica spectrum disorder (NMOSD) is developing rapidly. We aimed to investigate the safety and efficacy of rituximab, an anti-CD20 monoclonal antibody, against relapses in patients with NMOSD.
METHODS


We did a multicentre, randomised, double-blind, placebo-controlled clinical trial at eight hospitals in Japan. Patients aged 16-80 years with NMOSD who were seropositive for aquaporin 4 (AQP4) antibody, were taking 5-30 mg/day oral steroids, and had an Expanded Disability Status Scale (EDSS) score of 7·0 or less were eligible for the study. Individuals taking any other immunosuppressants were excluded. Participants were randomly allocated (1:1) either rituximab or placebo by a computer-aided dynamic random allocation system. The doses of concomitant steroid (converted to equivalent doses of prednisolone) and relapses in previous 2 years were set as stratification factors. Participants and those assessing outcomes were unaware of group assignments. Rituximab (375 mg/m 2 ) was administered intravenously every week for 4 weeks, then 6-month interval dosing was done (1000 mg every 2 weeks, at 24 weeks and 48 weeks after randomisation). A matching placebo was administered intravenously. Concomitant oral prednisolone was gradually reduced to 2-5 mg/day, according to the protocol. The primary outcome was time to first relapse within 72 weeks. Relapses were defined as patient-reported symptoms or any new signs consistent with CNS lesions and attributable objective changes in MRI or visual evoked potential. The primary analysis was done in the full analysis set (all randomly assigned patients) and safety analyses were done in the safety analysis set (all patients who received at least one infusion of assigned treatment). The primary analysis was by intention-to-treat principles. This trial is registered with the UMIN clinical trial registry, UMIN000013453.
FINDINGS


Between May 10, 2014, and Aug 15, 2017, 38 participants were recruited and randomly allocated either rituximab (n=19) or placebo (n=19). Three (16%) patients assigned rituximab discontinued the study and were analysed as censored cases. Seven (37%) relapses occurred in patients allocated placebo and none were recorded in patients assigned rituximab (group difference 36·8%, 95% CI 12·3-65·5; log-rank p=0·0058). Eight serious adverse events were recorded, four events in three (16%) patients assigned rituximab (lumbar compression fracture and infection around nail of right foot [n=1], diplopia [n=1], and uterine cancer [n=1]) and four events in two (11%) people allocated to placebo (exacerbation of glaucoma and bleeding in the right eye chamber after surgery [n=1], and visual impairment and asymptomatic white matter brain lesion on MRI [n=1]); all patients recovered. No deaths were reported.
INTERPRETATION


Rituximab prevented relapses for 72 weeks in patients with NMOSD who were AQP4 antibody-positive. This study is limited by its small sample size and inclusion of participants with mild disease activity. However, our results suggest that rituximab could be useful maintenance therapy for individuals with NMOSD who are AQP4 antibody-positive.
FUNDING


Japanese Ministry of Health, Labour and Welfare, Japan Agency for Medical Research and Development, and Zenyaku Kogyo.",2020,"No deaths were reported.
","['neuromyelitis optica spectrum disorders (RIN-1 study', 'Patients aged 16-80 years with NMOSD who were seropositive for aquaporin 4 (AQP4) antibody, were taking 5-30 mg/day oral steroids, and had an Expanded Disability Status Scale (EDSS) score of 7·0 or less were eligible for the study', 'patients with neuromyelitis optica spectrum disorder (NMOSD', 'individuals with NMOSD who are AQP4 antibody-positive', 'eight hospitals in Japan', 'Between May 10, 2014, and Aug 15, 2017, 38 participants', 'participants with mild disease activity', 'patients with NMOSD']","['concomitant steroid', 'Rituximab', 'rituximab or placebo', 'placebo', 'rituximab', 'prednisolone', 'Concomitant oral prednisolone']","['Safety and efficacy', 'Relapses', 'safety and efficacy', 'time to first relapse']","[{'cui': 'C0027873', 'cui_str': ""Devic's Neuromyelitis Optica""}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C2919772', 'cui_str': 'Aquaporin-4 antibody'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",38.0,0.757995,"No deaths were reported.
","[{'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan. Electronic address: tahara.masayuki.ne@mail.hosp.go.jp.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Oeda', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Neurology, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Kiriyama', 'Affiliation': 'Department of Neurology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Ochi', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hikoaki', 'Initials': 'H', 'LastName': 'Fukaura', 'Affiliation': 'Department of Neurology, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakashima', 'Affiliation': 'Department of Neurology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Misu', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Umemura', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Sawada', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30066-1']
460,32186238,Effectiveness of elevated vacuum and suction prosthetic suspension systems in managing daily residual limb fluid volume change in people with transtibial amputation.,"BACKGROUND


Previous studies investigating limb volume change with elevated vacuum have shown inconsistent results and have been limited by out-of-socket volume measurements and short, single-activity protocols.
OBJECTIVES


To evaluate the effectiveness of elevated vacuum for managing limb fluid volume compared to suction suspension with an in-socket measurement modality during many hours of activity.
STUDY DESIGN


Fixed-order crossover design with a standardized out-of-laboratory activity protocol.
METHODS


Transtibial electronic elevated vacuum users participated in two sessions. Elevated vacuum was used during the first session, and suction suspension in the second. Participants completed a 5.5-h protocol consisting of multiple intervals of activity. In-socket residual limb fluid volume was continuously measured using a custom portable bioimpedance analyzer.
RESULTS


A total of 12 individuals participated. Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum. Although individual results varied, 11 participants experienced lower overall rates of fluid volume loss in at least one limb region using elevated vacuum.
CONCLUSION


Elevated vacuum may be more effective as a volume management strategy after accumulation of activity. Individual variation suggests the potential to optimize the limb fluid volume benefits of elevated vacuum by reducing socket vacuum pressure for some users.
CLINICAL RELEVANCE


A better understanding of how elevated vacuum (EV) affects residual limb fluid volume will allow prosthetists to make more informed clinical decisions regarding accommodation strategies designed to improve daily socket fit.",2020,"Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum.","['people with transtibial amputation', '12 individuals participated', 'Transtibial electronic elevated vacuum users participated in two sessions']","['elevated vacuum and suction prosthetic suspension systems', 'suction suspension']","['socket vacuum pressure', 'overall rates of fluid volume loss', 'Overall rate of fluid volume change']","[{'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",12.0,0.198244,"Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Youngblood', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Brzostowski', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hafner', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Czerniecki', 'Affiliation': 'VA Center for Limb Loss and Mobility, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'Katheryn J', 'Initials': 'KJ', 'LastName': 'Allyn', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Foster', 'Affiliation': 'TGG Prosthetics & Orthotics, Edmond, OK, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}]",Prosthetics and orthotics international,['10.1177/0309364620909044']
461,32169259,Investigation of the effect of sensorimotor exercises on proprioceptive perceptions among children with spastic hemiplegic cerebral palsy.,"STUDY DESIGN


This is a blinded randomized clinical trial.
INTRODUCTION


Sensorimotor exercises may be an effective, noninvasive treatment modality for treating patients with pediatric spastic hemiplegic cerebral palsy (CP).
PURPOSE OF THE STUDY


We aim to evaluate the effect of sensorimotor exercises on the proprioceptive capability among children with spastic hemiplegic CP.
METHODS


This randomized clinical trial was performed on children with spastic hemiplegic CP. Thirty children aged 8 to 12 years old, with spastic hemiplegic CP, were randomly selected and equally divided into experimental and control groups (N = 15 for each). A joint positioning test was used to measure the patients' baseline proprioceptive ability. The exercise program included sensory and motor exercises which lasted for 8 weeks (three 60-min sessions per week). The data were analyzed by using Welch and paired-sample t-test at the significance level of P < .05.
RESULTS


The results indicated that the proprioceptive capability of the upper limb could significantly improve (P = .001, effect size = 0.41, observed power = 0.99) by using simultaneous exercising of the sensorimotor complex. The mean increased from 8.53 ± 1.6 to 10.53 ± 1.19 in the experimental group, whereas it changed from 6.66 ± 3.44 to 6.73 ± 3.15 in the control group.
DISCUSSION


In consistent with other studies, the exercises used in the present study enhanced the proprioceptive capability but not sensory performance of the hands of children with hemiplegic. Synchronous sensory and motor training in children with hemiplegic CP may improve the function and organization of the somatosensory cortex and reduce sensory disturbances. Although parents were subjectively satisfied with the outcome of the exercises, such as independency and life style, however these recordings were not measured in this study.
CONCLUSION


Implementing simultaneous sensorimotor exercises can improve the proprioceptive capability of the hand. Therefore, these exercises can be used in the rehabilitation programs to meet the children's needs with hemiplegic CP.",2020,"The results indicated that the proprioceptive capability of the upper limb could significantly improve (P = .001, effect size = 0.41, observed power = 0.99) by using simultaneous exercising of the sensorimotor complex.","['children with spastic hemiplegic CP', 'children with spastic hemiplegic cerebral palsy', 'patients with pediatric spastic hemiplegic cerebral palsy (CP', 'Thirty children aged 8 to 12 years old, with spastic hemiplegic CP', 'children with hemiplegic CP', ""children's needs with hemiplegic CP""]","['Synchronous sensory and motor training', 'sensorimotor exercises', 'Sensorimotor exercises']","['proprioceptive capability', 'proprioceptive perceptions', 'proprioceptive capability of the upper limb']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",30.0,0.0236708,"The results indicated that the proprioceptive capability of the upper limb could significantly improve (P = .001, effect size = 0.41, observed power = 0.99) by using simultaneous exercising of the sensorimotor complex.","[{'ForeName': 'Akram Ahmadi', 'Initials': 'AA', 'LastName': 'Barati', 'Affiliation': 'Department of Physical Education and Sport Science, University of Tehran Alborz Campus, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rajabi', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Health and Sports Medicine, University of Tehran, Tehran, Iran. Electronic address: rrajabi@ut.ac.ir.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Shahrbanian', 'Affiliation': 'Department of Sports Medicine, University of Tehran, Tehran, Iran; Department of Sport Injuries & Corrective Exercise, Faculty of Physical Education and Sport Sciences, Bu-Ali Sina University, Hamedan, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Sedighi', 'Affiliation': 'Department of Neurology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.003']
462,32171731,Methods for Dissecting Intersegmental Planes in Segmentectomy: A Randomized Controlled Trial.,"BACKGROUND


The perioperative outcomes of the use of stapling devices versus electrocautery to dissect intersegmental planes in patients undergoing segmentectomy for small pulmonary lesions is still unclear. The aim of this randomized controlled trial was to compare the perioperative outcomes of these two methods.
METHODS


A single-center, prospective, participant-blinded, randomized controlled trial (NCT03192904) was conducted with a preplanned sample size of 136. The primary outcome was the incidence of postoperative complications. Secondary outcomes included duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function, and medical costs.
RESULTS


The trial was stopped early as a result of a marked difference in the primary outcome between groups at a scheduled interim check of the data after recruiting 70 patients. The incidence of postoperative complications (eg, air leakage) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs 2/33, 6.1%, P = .004). There were no differences in duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials was higher in the stapler device group (US$4214.6 ± 1185.4 vs $3260.1 ± 852.6, P < .001).
CONCLUSIONS


Among patients undergoing segmentectomy, the use of stapler devices to divide intersegmental planes decreased postoperative complications without further compromising lung function or increasing economic burden.",2020,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","['Segmentectomy', 'patients undergoing segmentectomy', 'patients undergoing segmentectomy for small pulmonary lesions']",['stapling devices versus electrocautery'],"['postoperative complications', 'surgery duration, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials', 'incidence of postoperative complications', 'duration of surgery, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function and medical costs', 'incidence of postoperative complications (e.g., air leakage etc']","[{'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333257', 'cui_str': 'Air leakage (morphologic abnormality)'}]",70.0,0.196245,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","[{'ForeName': 'Xingshi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Dingpei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Chengqiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Hailei', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Junbiao', 'Initials': 'J', 'LastName': 'Hang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Alan D L', 'Initials': 'ADL', 'LastName': 'Sihoe', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Hong Kong; The University of Hong Kong Shenzhen Hospital, Shenzhen; Department of Thoracic Surgery, Tongji University, Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Hecheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai. Electronic address: lihecheng2000@hotmail.com.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.02.013']
463,31993993,Laparoscopy and resection with primary anastomosis for perforated diverticulitis: challenging old dogmas.,"Diverticulitis is a common disease in western countries, and its incidence is likely expected to increase over years. The burden of diverticular disease on health systems and resources utilization cannot be underestimated, given the high prevalence of diverticulosis and the rate of patients requiring hospitalization and/or surgery. Minimally invasive colorectal surgery can guarantee several benefits over traditional open surgery, even more prominently in the emergency settings. However, there is moderate to low agreement regarding the use of a minimally invasive approach in patients with perforated diverticular disease (Hinchey III/IV), as well as primary anastomosis is still feared too risky versus end colostomy. Over the last years, evidence has been growing that laparoscopy can reduce the magnitude of surgical injury, and last but not least, cause less adhesions and/or incisional hernias, and lead to easier subsequent surgeries. The recently published results from the DIVA arm of the Ladies trial showed that 12-month stoma-free survival was significantly better for patients randomized to primary anastomosis compared with patients who received Hartmann's procedure, without differences in short-term morbidity and mortality after index resection. Moreover, several recent studies showed that laparoscopic sigmoidectomy in the treatment of Hinchey III-IV diverticulitis is feasible in haemodynamically stable patients. Taken together, these findings suggest that laparoscopic sigmoidectomy is at least feasible and safe in this challenging subgroup of patients. However, patient selection and additional factors, including surgeon expertise and hospital resources, are crucial and need careful consideration.",2020,"Over the last years, evidence has been growing that laparoscopy can reduce the magnitude of surgical injury, and last but not least, cause less adhesions and/or incisional hernias, and lead to easier subsequent surgeries.","['patients with perforated diverticular disease (Hinchey III/IV', 'haemodynamically stable patients']","['laparoscopic sigmoidectomy', 'Laparoscopy and resection with primary anastomosis', 'Minimally invasive colorectal surgery']",['12-month stoma-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4317009', 'cui_str': 'Diverticular Diseases'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}]","[{'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy (procedure)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0651487,"Over the last years, evidence has been growing that laparoscopy can reduce the magnitude of surgical injury, and last but not least, cause less adhesions and/or incisional hernias, and lead to easier subsequent surgeries.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pellino', 'Affiliation': 'Department of Advanced Medical and Surgical Sciences, Università Degli Studi Della Campania ""Luigi Vanvitelli"", Piazza Miraglia 2, 80138, Naples, Italy. gipe1984@gmail.com.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Podda', 'Affiliation': 'Department of Surgical Science, Cagliari University Hospital ""Policlinico Universitario D. Casula, University of Cagliari, SS 554, Km 4,500, 09042, Cagliari, Italy.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wheeler', 'Affiliation': ""Cambridge Colorectal Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': ""Cambridge Colorectal Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Salomone', 'Initials': 'S', 'LastName': 'Di Saverio', 'Affiliation': ""Cambridge Colorectal Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.""}]",Updates in surgery,['10.1007/s13304-020-00708-7']
464,31884186,Non-invasive stimulation of vagal afferents reduces gastric frequency.,"Metabolic feedback between the gut and the brain relayed via the vagus nerve contributes to energy homeostasis. We investigated in healthy adults whether non-invasive stimulation of vagal afferents impacts energy homeostasis via efferent effects on metabolism or digestion. In a randomized crossover design, we applied transcutaneous auricular vagus nerve stimulation (taVNS) while recording efferent metabolic effects using simultaneous electrogastrography (EGG) and indirect calorimetry. We found that taVNS reduced gastric myoelectric frequency (p = .008), but did not alter resting energy expenditure. We conclude that stimulating vagal afferents induces gastric slowing via vagal efferents without acutely affecting net energy expenditure at rest. Collectively, this highlights the potential of taVNS to modulate digestion by activating the dorsal vagal complex. Thus, taVNS-induced changes in gastric frequency are an important peripheral marker of brain stimulation effects.",2020,"We found that taVNS reduced gastric myoelectric frequency (p = .008), but did not alter resting energy expenditure.",['healthy adults'],"['simultaneous electrogastrography (EGG) and indirect calorimetry', 'transcutaneous auricular vagus nerve stimulation (taVNS']","['gastric frequency', 'gastric myoelectric frequency', 'Metabolic feedback']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0430689', 'cui_str': 'Electromyography of stomach (procedure)'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0234329,"We found that taVNS reduced gastric myoelectric frequency (p = .008), but did not alter resting energy expenditure.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teckentrup', 'Affiliation': 'University of Tübingen, Department of Psychiatry and Psychotherapy, Germany. Electronic address: vanessa.teckentrup@uni-tuebingen.de.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Neubert', 'Affiliation': 'University of Tübingen, Department of Psychiatry and Psychotherapy, Germany.'}, {'ForeName': 'João C P', 'Initials': 'JCP', 'LastName': 'Santiago', 'Affiliation': 'University of Tübingen, Department of Medical Psychology and Behavioral Neurobiology, Germany; German Center for Diabetes Research (DZD), Tübingen, Germany; Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Hallschmid', 'Affiliation': 'University of Tübingen, Department of Medical Psychology and Behavioral Neurobiology, Germany; German Center for Diabetes Research (DZD), Tübingen, Germany; Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'University of Tübingen, Department of Psychiatry and Psychotherapy, Germany; University of Magdeburg, Department of Psychiatry and Psychotherapy, Germany; Leibniz Institute for Neurobiology, Magdeburg, Germany; University of Jena, Department of Psychiatry and Psychotherapy, Germany.'}, {'ForeName': 'Nils B', 'Initials': 'NB', 'LastName': 'Kroemer', 'Affiliation': 'University of Tübingen, Department of Psychiatry and Psychotherapy, Germany. Electronic address: nils.kroemer@uni-tuebingen.de.'}]",Brain stimulation,['10.1016/j.brs.2019.12.018']
465,32053149,HSD3B1 Genotype and Clinical Outcomes in Metastatic Castration-Sensitive Prostate Cancer.,"Importance


The adrenal-restrictive HSD3B1(1245A) allele limits extragonadal dihydrotestosterone synthesis, whereas the adrenal-permissive HSD3B1(1245C) allele augments extragonadal dihydrotestosterone synthesis. Retrospective studies have suggested an association between the adrenal-permissive allele, the frequency of which is highest in white men, and early development of castration-resistant prostate cancer (CRPC).
Objective


To examine the association between the adrenal-permissive HSD3B1(1245C) allele and early development of CRPC using prospective data.
Design, Setting, and Participants


The E3805 Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a large, multicenter, phase 3 trial of castration with or without docetaxel treatment in men with newly diagnosed metastatic prostate cancer. From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples. In this study, the HSD3B1 germline genotype was retrospectively determined in 475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype. Data analysis was performed from July 28, 2006, to October 17, 2018.
Interventions


Men were randomized to castration plus docetaxel, 75 mg/m2, every 3 weeks for 6 cycles or castration alone.
Main Outcomes and Measures


Two-year freedom from CRPC and 5-year overall survival, with results stratified by disease volume. Patients were combined across study arms according to genotype to assess the overall outcome associated with genotype. Secondary analyses by treatment arm evaluated whether the docetaxel outcome varied with genotype.
Results


Of 475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele). Mean (SD) age was 63 (8.7) years. Freedom from CRPC at 2 years was diminished in men with low-volume disease with the adrenal-permissive vs adrenal-restrictive genotype: 51.0% (95% CI, 40.9%-61.2%) vs 70.5% (95% CI, 60.0%-80.9%) (P = .01). Overall survival at 5 years was also worse in men with low-volume disease with the adrenal-permissive genotype: 57.5% (95% CI, 47.4%-67.7%) vs 70.8% (95% CI, 60.3%-81.3%) (P = .03). Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death. There was no association between genotype and outcomes in men with high-volume disease. There was no interaction between genotype and benefit from docetaxel.
Conclusions and Relevance


Inheritance of the adrenal-permissive HSD3B1 genotype is associated with earlier castration resistance and shorter overall survival in men with low-volume metastatic prostate cancer and may help identify men more likely to benefit from escalated androgen receptor axis inhibition beyond gonadal testosterone suppression.",2020,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","['Mean (SD) age was 63 (8.7) years', 'men with newly diagnosed metastatic prostate cancer', '475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele', 'From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples', 'men with high-volume disease', 'men with low-volume metastatic prostate cancer', 'Interventions\n\n\nMen', '475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype', 'Metastatic Castration-Sensitive Prostate Cancer']","['castration alone', 'castration with or without docetaxel treatment', 'castration plus docetaxel', 'E3805 Chemohormonal Therapy vs Androgen Ablation']","['Measures\n\n\nTwo-year freedom from CRPC and 5-year overall survival', 'Overall survival', 'Hazard ratios', 'docetaxel outcome varied with genotype', 'overall survival']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]",475.0,0.105053,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","[{'ForeName': 'Jason W D', 'Initials': 'JWD', 'LastName': 'Hearn', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Almassi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Reichard', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chandana A', 'Initials': 'CA', 'LastName': 'Reddy', 'Affiliation': 'Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hobbs', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Jarrard', 'Affiliation': 'Department of Medical Oncology, University of Wisconsin Hospital and Clinics, Madison.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'Department of Medical Oncology, University of Kentucky, Lexington.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Sharifi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6496']
466,31879164,Short-term postoperative CPAP may improve the outcomes of velopharyngeal surgery for obstructive sleep apnea.,"PURPOSE


To evaluate the effects of short-term postoperative continuous positive airway pressure (CPAP) on the outcomes of velopharyngeal surgery for obstructive sleep apnea (OSA).
MATERIALS AND METHODS


This study included 119 OSA patients who underwent velopharyngeal surgery. Based on the results of postoperative pulse oximetry, the patients were divided into 3 groups: intervention, control, and observation. Patients with oxygen desaturation index (ODI) > 10 and lowest SpO 2  < 90% were randomly assigned to the CPAP intervention group and non-CPAP control. Patients with ODI ≤10 or lowest SpO 2  ≥ 90% were assigned to the non-CPAP observation group. Patients in the intervention group completed at least 3 months of CPAP treatment. Postoperative polysomnography data were compared to assess the difference of prognosis between the three groups.
RESULTS


Baseline data showed no significant differences between the three groups except the observational group showed a significantly larger tonsil size relative to the intervention and control groups. However, there was no significant difference in terms of tonsil size between the control and intervention groups. The surgical success rate of the intervention group was 80.65%, whereas it was 55.17% in the control group, with significant difference. The success rate of the observation group was 85.71% which was significantly different from that of the control group, but not the intervention group.
CONCLUSION


Short-term postoperative CPAP treatment may improve the outcomes of velopharyngeal surgery for OSA in patients who have respiratory events related hypoxia after surgery. Further studies are necessary for the underlying mechanisms.",2020,"The success rate of the observation group was 85.71% which was significantly different from that of the control group, but not the intervention group.
","['Patients with ODI ≤10 or lowest SpO 2', 'obstructive sleep apnea', '119 OSA patients who underwent', 'obstructive sleep apnea (OSA', 'Patients with oxygen desaturation index (ODI)\xa0>\xa010 and lowest SpO 2', 'patients who have respiratory events related hypoxia after surgery']","['velopharyngeal surgery', 'short-term postoperative continuous positive airway pressure (CPAP', 'CPAP intervention group and non-CPAP control']","['surgical success rate', 'larger tonsil size relative', 'tonsil size', 'success rate', 'Postoperative polysomnography data']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0549123', 'cui_str': 'Large tonsils (finding)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0040421', 'cui_str': 'Tonsil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]",119.0,0.02134,"The success rate of the observation group was 85.71% which was significantly different from that of the control group, but not the intervention group.
","[{'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Yin', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jinkun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China. Electronic address: yejingying@vip.163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2019.102373']
467,31889671,Effects of the Anaesthetic-ECT time interval and ventilation rate on seizure quality in electroconvulsive therapy: A prospective randomised trial.,"BACKGROUND


The anaesthetic approach adopted in ECT practice has the potential to influence patient outcomes. However, the impact of the time interval between anaesthetic induction and ECT stimulus administration has not been studied prospectively to date. This variable may represent an indirect measure of anaesthetic concentration at the time of stimulation, and therefore may influence the quality of seizures induced.
OBJECTIVE


To examine the impact of the anaesthetic to ECT stimulus time interval, and ventilation rate pre-treatment, on ictal seizure quality.
METHODS


In a prospective, crossover trial, 54 depressed participants were randomised to variations in anaesthetic technique at four sequential ECT treatment sessions, in a 2 x 2 design: randomisation to a short or long anaesthetic-ECT time interval, and randomisation to normal ventilation or hyperventilation during anaesthetic induction with thiopentone. Ictal EEG data were collected at each study session and assessed by a blinded rater for ictal quality (seizure amplitude, regularity, post-ictal suppression and general seizure quality), using a quantitative-qualitative structured rating scale. Linear mixed effects models were used to analyse the effect of the anaesthetic-ECT time interval, and that of ventilation rate, on seizure quality indices.
RESULTS


The anaesthetic-ECT time interval had a significant impact on ictal EEG quality indices (p < 0.01), with longer time intervals producing higher quality seizures. Ventilation rate did not significantly influence quality measures.
CONCLUSION


The time between anaesthetic induction and ECT stimulus administration has a significant impact on ictal EEG seizure quality. Conversely, manipulations of ventilation rate did not significantly affect seizure quality. These results suggest the anaesthetic-ECT time interval should be routinely monitored clinically and potentially optimised for maximising seizure quality with ECT.",2020,"The anaesthetic-ECT time interval had a significant impact on ictal EEG quality indices (p < 0.01), with longer time intervals producing higher quality seizures.",['54 depressed participants'],"['Anaesthetic-ECT time interval and ventilation rate', 'short or long anaesthetic-ECT time interval, and randomisation to normal ventilation or hyperventilation', 'thiopentone', 'electroconvulsive therapy']","['ventilation rate', 'ventilation rate, on seizure quality indices', 'ictal EEG quality indices', 'ictal quality (seizure amplitude, regularity, post-ictal suppression and general seizure quality), using a quantitative-qualitative structured rating scale', 'ictal EEG seizure quality', 'Ictal EEG data', 'seizure quality', 'quality seizures', 'Ventilation rate']",[],"[{'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0449581', 'cui_str': 'Regularity (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0222045'}]",54.0,0.159011,"The anaesthetic-ECT time interval had a significant impact on ictal EEG quality indices (p < 0.01), with longer time intervals producing higher quality seizures.","[{'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'School of Psychiatry, University of New South Wales, Randwick, NSW, 2031, Australia; Black Dog Institute, Hospital Road, Randwick, NSW, 2031, Australia; Concord Centre for Mental Health, Concord, NSW, 2137, Australia; Health Education & Training Institute, Gladesville, NSW, 2111, Australia. Electronic address: rohan.taylor@unsw.edu.au.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Wark', 'Affiliation': ""School of Psychiatry, University of New South Wales, Randwick, NSW, 2031, Australia; The Wesley Hospital, 7 Blake St, Kogarah, NSW, 2217, Australia; The Sydney Clinic, 22-24 Murray St, Bronte, NSW, 2024, Australia; Children's Hospital Westmead, Hawkesbury Road & Hainsworth Street, Westmead, NSW, 2145, Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Leyden', 'Affiliation': 'The Wesley Hospital, 7 Blake St, Kogarah, NSW, 2217, Australia; Royal North Shore Hospital, Reserve Rd, St Leonards, NSW, 2065, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Simpson', 'Affiliation': 'School of Psychiatry, University of New South Wales, Randwick, NSW, 2031, Australia; The Wesley Hospital, 7 Blake St, Kogarah, NSW, 2217, Australia; St. George Hospital, Gray St, Kogarah, NSW, 2217, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'McGoldrick', 'Affiliation': 'The Wesley Hospital, 7 Blake St, Kogarah, NSW, 2217, Australia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Hadzi-Pavlovic', 'Affiliation': 'School of Psychiatry, University of New South Wales, Randwick, NSW, 2031, Australia; Black Dog Institute, Hospital Road, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Hank Ke', 'Initials': 'HK', 'LastName': 'Han', 'Affiliation': 'The Wesley Hospital, 7 Blake St, Kogarah, NSW, 2217, Australia.'}, {'ForeName': 'Stevan', 'Initials': 'S', 'LastName': 'Nikolin', 'Affiliation': 'School of Psychiatry, University of New South Wales, Randwick, NSW, 2031, Australia; Black Dog Institute, Hospital Road, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Donel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Psychiatry, University of New South Wales, Randwick, NSW, 2031, Australia; Black Dog Institute, Hospital Road, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Loo', 'Affiliation': 'School of Psychiatry, University of New South Wales, Randwick, NSW, 2031, Australia; Black Dog Institute, Hospital Road, Randwick, NSW, 2031, Australia; The Wesley Hospital, 7 Blake St, Kogarah, NSW, 2217, Australia; St. George Hospital, Gray St, Kogarah, NSW, 2217, Australia; Northside Group St Leonards Clinic, 2 Frederick St, St Leonards, NSW, 2065, Australia.'}]",Brain stimulation,['10.1016/j.brs.2019.12.012']
468,32033271,Decreasing the Impact of Anxiety on Cancer Prevention through Online Intervention.,"BACKGROUND


Low levels of public knowledge, incorrect beliefs, and anxiety are the most often mentioned factors that may negatively affect the implementation of preventive campaigns and timely diagnosis of cancer. Cancer is a major unresolved problem for global public health. As a result, many effective preventive measures need to be found and implemented.
METHODS


For a duration of 18 months, readers of the Polish scientific Internet portal were invited to participate in the Polish On-line Randomized Intervention aimed at Neoplasm Avoidance (PORINA) study. Level of cancer-related anxiety was our main measure (self-declared on a simple five-point Likert scale) in this analysis.
RESULTS


A total of 463 participants were qualified for the final analysis. Respondents with a positive family history of cancer ( p  < 0.001) declared the highest level of cancer-related anxiety, whereas lower levels were declared by those previously treated for cancer ( p  = 0.006). The conducted educational intervention reduced the declared level of cancer-related anxiety.
CONCLUSIONS


The results of this study provide evidence that the use of web-based interventions aimed at increasing awareness could reduce cancer-related anxiety and may lead to more frequent consent to undergo some of the medical procedures used to diagnose or treat cancer.",2020,"Respondents with a positive family history of cancer ( p  < 0.001) declared the highest level of cancer-related anxiety, whereas lower levels were declared by those previously treated for cancer ( p  = 0.006).",['463 participants were qualified for the final analysis'],[],"['declared level of cancer-related anxiety', 'highest level of cancer-related anxiety', 'Level of cancer-related anxiety']","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",463.0,0.0309313,"Respondents with a positive family history of cancer ( p  < 0.001) declared the highest level of cancer-related anxiety, whereas lower levels were declared by those previously treated for cancer ( p  = 0.006).","[{'ForeName': 'Maksymilian', 'Initials': 'M', 'LastName': 'Gajda', 'Affiliation': 'Department of Epidemiology, School of Medicine in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Kowalska', 'Affiliation': 'Department of Epidemiology, School of Medicine in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17030985']
469,31848068,Transcranial direct current stimulation facilitates category learning.,"BACKGROUND


After two decades of transcranial direct current stimulation (tDCS) research, it is still unclear which applications benefit most from which tDCS protocols. One prospect is the acceleration of learning, where previous work has demonstrated that anodal tDCS applied to the right ventrolateral prefrontal cortex (rVLPFC) is capable of doubling the rate of learning in a visual camouflaged threat detection and category learning task.
GOALS


Questions remain as to the specific cognitive mechanisms underlying this learning enhancement, and whether it generalizes to other tasks. The goal of the current project was to expand previous findings by employing a novel category learning task.
METHODS


Participants learned to classify pictures of European streets within a discovery learning paradigm. In a double-blind design, 54 participants were randomly assigned to 30 min of tDCS using either 2.0 mA anodal (n = 18), cathodal (n = 18), or 0.1 mA sham (n = 18) tDCS over the rVLPFC.
RESULTS


A linear mixed-model revealed a significant effect of tDCS condition on classification accuracy across training (p = 0.001). Compared to a 4.2% increase in sham participants, anodal tDCS over F10 increased performance by 20.6% (d = 1.71) and cathodal tDCS by 14.4% (d = 1.16).
CONCLUSIONS


These results provide further evidence for the capacity of tDCS applied to rVLPFC to enhance learning, showing a greater than quadrupling of test performance after training (491% of sham) in a difficult category learning task. Combined with our previous studies, these results suggest a generalized performance enhancement. Other tasks requiring sustained attention, insight and/or category learning may also benefit from this protocol.",2020,"Compared to a 4.2% increase in sham participants, anodal tDCS over F10 increased performance by 20.6% (d = 1.71) and cathodal tDCS by 14.4% (d = 1.16).
","['Participants learned to classify pictures of European streets within a discovery learning paradigm', '54 participants']","['Transcranial direct current stimulation facilitates category learning', 'transcranial direct current stimulation (tDCS', 'tDCS using either 2.0\xa0mA anodal']","['cathodal tDCS', 'anodal tDCS over F10 increased performance']","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",54.0,0.0349046,"Compared to a 4.2% increase in sham participants, anodal tDCS over F10 increased performance by 20.6% (d = 1.71) and cathodal tDCS by 14.4% (d = 1.16).
","[{'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Gibson', 'Affiliation': 'Psychology Clinical Neuroscience Center, Dept. Psychology, MSC03-2220, University of New Mexico, Albuquerque, NM, 87131, USA; Department of Psychology, University of New Mexico, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Teagan S', 'Initials': 'TS', 'LastName': 'Mullins', 'Affiliation': 'Psychology Clinical Neuroscience Center, Dept. Psychology, MSC03-2220, University of New Mexico, Albuquerque, NM, 87131, USA; Department of Psychology, University of New Mexico, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Heinrich', 'Affiliation': 'Psychology Clinical Neuroscience Center, Dept. Psychology, MSC03-2220, University of New Mexico, Albuquerque, NM, 87131, USA; Department of Psychology, University of New Mexico, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, 87131, USA; Center on Alcoholism, Substance Abuse, & Addictions, Albuquerque, NM, 87106, USA.'}, {'ForeName': 'Alfred B', 'Initials': 'AB', 'LastName': 'Yu', 'Affiliation': 'CCDC, Army Research Laboratory, Human Research and Engineering Directorate, Aberdeen Proving Ground, MD, 21005, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Hansberger', 'Affiliation': 'CCDC, Army Research Laboratory, Human Research and Engineering Directorate, Aberdeen Proving Ground, MD, 21005, USA; U.S. Army Research Laboratory, Huntsville, AL, 35898, USA.'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Clark', 'Affiliation': 'Psychology Clinical Neuroscience Center, Dept. Psychology, MSC03-2220, University of New Mexico, Albuquerque, NM, 87131, USA; Department of Psychology, University of New Mexico, Albuquerque, NM, 87131, USA; The Mind Research Network of the Lovelace Biomedical Research Institute, 1101 Yale Blvd. NE, Albuquerque, NM, 87106, USA. Electronic address: vclark@unm.edu.'}]",Brain stimulation,['10.1016/j.brs.2019.11.010']
470,30679318,Everolimus plus Exemestane for Hormone Receptor-Positive Advanced Breast Cancer: A PAM50 Intrinsic Subtype Analysis of BOLERO-2.,"BACKGROUND


The prognostic and predictive value of the two nonluminal (human epidermal growth factor receptor 2 [HER2]-enriched and basal-like) subtypes within advanced hormone receptor-positive (HR+) breast cancer is currently unknown.
MATERIALS AND METHODS


This study retrospectively analyzed 261 tumors (80.7% primary; 19.3% metastatic) from the BOLERO-2 study; BOLERO-2 randomized 724 patients with advanced HR+/HER2-negative breast cancer to everolimus plus exemestane or placebo plus exemestane. Tumors were classified using a PAM50 subtype predictor. Multivariable Cox regression analyses tested the independent prognostic significance of PAM50, and associations between PAM50 subtypes and treatment upon progression-free survival (PFS) were evaluated.
RESULTS


Subtype distribution was 46.7% luminal A ( n  = 122), 21.5% HER2-enriched ( n  = 56), 15.7% luminal B ( n  = 41), 14.2% normal-like ( n  = 37), and 1.9% basal-like ( n  = 5); HER2-enriched subtypes were more common in metastatic versus primary tumors (32.0% vs. 18.7%;  p  = .038). Median PFS differences between luminal and nonluminal (6.7 vs. 5.2 months; adjusted hazard ratio, 0.66; 95% confidence interval [CI], 0.47-0.94;  p  = .020) and HER2-enriched and non-HER2-enriched subtypes (5.2 vs. 6.2 months; adjusted hazard ratio, 1.53; 95% CI, 1.07-2.19;  p  = .019) were significant. Everolimus plus exemestane significantly improved median PFS versus placebo plus exemestane among patients with HER2-enriched tumors (5.8 vs. 4.1 months; adjusted hazard ratio, 0.49; 95% CI, 0.26-0.90;  p  = .034); however, the association between HER2-enriched tumors and everolimus benefit was nonsignificant ( p  = .433).
CONCLUSION


The HER2-enriched subtype was identified in a substantial proportion of advanced HR+/HER2-negative breast tumors, and was a consistent biomarker of poor prognosis. Tailored therapies are therefore needed for HER2-enriched tumors in the advanced HR+/HER2-negative breast cancer setting.
IMPLICATIONS FOR PRACTICE


Using 261 tumor samples from the BOLERO-2 phase III clinical trial, this study shows that a substantial proportion (20%-30%) of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancers do not have a luminal A or B gene expression profile. This group of patients with nonluminal disease has a poor survival outcome regardless of the addition of everolimus to exemestane. This is the second study that confirms the prognostic value of this biomarker. Overall, these findings indicate a necessity to design novel clinical trials targeting nonluminal disease within HR+/HER2-negative breast cancer.",2019,"Median PFS differences between luminal and nonluminal (6.7 vs. 5.2 months; adjusted hazard ratio, 0.66; 95% confidence interval [CI], 0.47-0.94;  p  = .020) and HER2-enriched and non-HER2-enriched subtypes (5.2 vs. 6.2 months; adjusted hazard ratio, 1.53; 95% CI, 1.07-2.19;  p  = .019) were significant.","['261 tumors (80.7% primary; 19.3% metastatic) from the BOLERO-2 study; BOLERO-2 randomized 724 patients with advanced HR+/HER2-negative breast cancer to', 'patients with HER2-enriched tumors', 'Hormone Receptor-Positive Advanced Breast Cancer']","['placebo plus exemestane', 'everolimus plus exemestane or placebo plus exemestane', 'Everolimus plus exemestane', 'Everolimus plus Exemestane', 'exemestane']","['Median PFS differences', 'median PFS', 'progression-free survival (PFS']","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0244436', 'cui_str': 'Bolero'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",724.0,0.154725,"Median PFS differences between luminal and nonluminal (6.7 vs. 5.2 months; adjusted hazard ratio, 0.66; 95% confidence interval [CI], 0.47-0.94;  p  = .020) and HER2-enriched and non-HER2-enriched subtypes (5.2 vs. 6.2 months; adjusted hazard ratio, 1.53; 95% CI, 1.07-2.19;  p  = .019) were significant.","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain alprat@clinic.ub.es.'}, {'ForeName': 'Jan Christoph', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York New York, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'University Hospital 12 de Octubre, Madrid, Spain.'}]",The oncologist,['10.1634/theoncologist.2018-0407']
471,32161942,A Pilot Randomized Clinical Trial of Brief Interventions to Encourage Quit Attempts in Smokers From Socioeconomic Disadvantage.,"INTRODUCTION


Cigarette smoking disproportionately affects communities of low socioeconomic status where greater smoking prevalence and poorer cessation rates have been observed. Utilizing brief evidence-based interventions to increase cessation attempts may be an effective and easily disseminable means by which to mitigate undue burden in this population.
AIMS AND METHODS


The current intervention randomized daily smokers (N = 57) recruited from a local community soup kitchen to receive either Brief (eg, 30 m) Motivational Interviewing, Nicotine Replacement Therapy (NRT) sampling, or a Referral-Only intervention. Approximately half of participants (50.9%) reported not completing high school and many reported either just (41.4%) or not (40.4%) meeting basic expenses. Follow-up was completed approximately 1-month postintervention.
RESULTS


Nonsignificant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size). Approximately 40% of the sample reported making a serious quit attempt at follow-up. Significant differences in cigarettes per day at follow-up, controlling for baseline, were observed, with participants in the Motivational Interviewing condition, only, reporting significant reductions. Participants randomized to the NRT condition were significantly more likely to report using NRT patch and lozenge at follow-up (large effect). There were no differences between groups with respect to seeking behavioral support. Finally, we found that subjective financial strain moderated the effect of condition on change in cigarette consumption where NRT sampling was more effective for participants reporting less financial strain.
CONCLUSIONS


Findings provide initial evidence for personalizing brief interventions to promote quit attempts in low-income smokers.
IMPLICATIONS


While most clinical research on tobacco use and dependence focuses on successful sustained abstinence, the current study is novel because it examined three brief interventions designed to increase the number of quit attempts made by a nontreatment-seeking group suffering from health disparities (ie, smokers from socioeconomic disadvantage). These data suggest that nontreatment-seeking smokers from socioeconomic disadvantage can be influenced by Brief MIs and these interventions should be used to motivate smokers from socioeconomic disadvantage to make a quit attempt. Future studies should examine combined MIs including pharmacological and behavioral interventions.",2020,"RESULTS


Non-significant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size).",[],"['local community soup kitchen to receive either brief (e.g., 30m) motivational interviewing, nicotine replacement therapy sampling, or a referral-only intervention']",[],[],"[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0453399', 'cui_str': 'Soup (substance)'}, {'cui': 'C0557653', 'cui_str': 'Kitchen (environment)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]",[],57.0,0.0266812,"RESULTS


Non-significant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size).","[{'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Steinberg', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Department of Psychiatry, New Brunswick, NJ.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Rosen', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Versella', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Borges', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Leyro', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa047']
472,32160504,Ultrasound-guided versus blind subacromial corticosteroid and local anesthetic injection in the treatment of subacromial impingement syndrome: A randomized study of efficacy.,"OBJECTIVES


This study aims to compare the effects of ultrasound (US)-guided and blind subacromial corticosteroid and local anesthetic (LA) injection in the treatment of subacromial impingement syndrome (SIS) on shoulder pain, range of motion (ROM), and functionality.
PATIENTS AND METHODS


The prospective study was conducted between 01 February 2017 and 31 May 2017. A total of 29 patients with clinical findings and magnetic resonance imaging (MRI) consistent with SIS were randomized into two groups: 14 patients received US-guided subacromial corticosteroid and LA injection and 15 patients received a blind subacromial corticosteroid and LA injection. Patients were evaluated before and one month after treatment. One patient was lost to follow up. The primary outcome measure was a visual analog scale (VAS) for shoulder pain. Secondary outcomes were active shoulder ROM in flexion and abduction, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the modified Constant-Murley Score (CMS).
RESULTS


Twenty-eight patients (11 males, 17 females; mean age 39.5 in the US guided group and 42.5 in the blind group; range 20 to 64 years in both groups) completed the study. There was a significant improvement in VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS in both groups four weeks after treatment (p<0.05). There was no between-group difference in VAS, ROM or DASH questionnaire scores. Following treatment, the modified CMS in the US-guided injection group was higher than in the blind injection group (p=0.02). However, when the mean change in modified CMS in the US-guided injection group was compared to that of the blind injection group, the difference was insignificant (p=0.23).
CONCLUSION


Both US-guided and blind subacromial steroid injection improve shoulder pain, ROM, and functionality in SIS; one treatment option was not found to be superior to the other. Therefore, blind injection can be performed in clinical settings where US is not available. Equally, blind injection can also be performed in patients who have a definite diagnosis of SIS based on clinical and MRI findings.",2020,"There was a significant improvement in VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS in both groups four weeks after treatment (p<0.05).","['subacromial impingement syndrome', 'Twenty-eight patients (11 males, 17 females; mean age 39.5 in the US guided group and 42.5 in the blind group; range 20 to 64 years in both groups) completed the study', 'patients who have a definite diagnosis of SIS based on clinical and MRI findings', '29 patients with clinical findings and magnetic resonance imaging (MRI) consistent with SIS were randomized into two groups: 14 patients received', '01 February 2017 and 31 May 2017', 'subacromial impingement syndrome (SIS']","['subacromial steroid injection', 'ultrasound (US)-guided and blind subacromial corticosteroid and local anesthetic (LA) injection', 'Ultrasound-guided versus blind subacromial corticosteroid and local anesthetic injection', 'US-guided subacromial corticosteroid and LA injection and 15 patients received a blind subacromial corticosteroid and LA injection']","['shoulder pain, ROM, and functionality in SIS', 'VAS, ROM or DASH questionnaire scores', 'VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS', 'visual analog scale (VAS) for shoulder pain', 'mean change in modified CMS', 'shoulder pain, range of motion (ROM), and functionality', 'active shoulder ROM in flexion and abduction, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the modified Constant-Murley Score (CMS']","[{'cui': 'C4255192', 'cui_str': 'Coracohumeral Impingement'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}]","[{'cui': 'C4302319', 'cui_str': 'Injection of steroid into subacromial region of shoulder'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",29.0,0.0519222,"There was a significant improvement in VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS in both groups four weeks after treatment (p<0.05).","[{'ForeName': 'Najibeh', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Başkent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Ozen', 'Affiliation': ''}, {'ForeName': 'Huma Bölük', 'Initials': 'HB', 'LastName': 'Şenlikçi', 'Affiliation': ''}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Haberal', 'Affiliation': ''}, {'ForeName': 'Nuri', 'Initials': 'N', 'LastName': 'Çetin', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.71056']
473,32162241,"Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults.","AIMS


Safety and tolerability of prolonged supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink (WP-MND) was evaluated in sarcopenic older adults.
METHODS


A 13-week double-blinded, randomized, isocaloric placebo-controlled trial (PROVIDE study; n = 380) was extended with a voluntary 13-week open-label extension (OLE). OLE participants were randomized to receive daily 1 or 2 servings of WP-MND (21 g protein, 3 g leucine, 10 µg vitD and 500 mg calcium per serving). Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium were evaluated at week 0, 13 and 26.
RESULTS AND DISCUSSION


In response to the high daily protein intake (median1.5; IQR: 1.3, 1.7 g/kg BW/day), the estimated glomerular filtration rate (eGFR) increased in the test group during the RCT (p = 0.013). The same trend was observed for those participants with moderate chronic kidney disease. During OLE no eGFR change was observed in any of the groups. Serum calcidiol and calcium reached a plateau after 13-week WP-MND supplementation. As expected, PTH significantly changed in the opposite direction, decreasing during RCT in the test group (T vs C: p < 0.001) and during OLE in former control groups. During RCT, 20/366 participants with normal baseline calcidiol reached levels ≥ 100 nmol/L (T: n = 18; C: n = 2) and 6 developed albumin-corrected calcium levels > 2.55 mmol/L (T: n = 3; C: n = 3), without associated adverse events.
CONCLUSION


A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity. The product was overall well tolerated.",2020,A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity.,"['OLE participants', 'study; n\u2009=\u2009380', 'participants with moderate chronic kidney disease', 'sarcopenic older adults']","['enriched whey protein medical nutrition drink (WP-MND', 'voluntary 13-week open-label extension (OLE', 'WP-MND', 'prolonged supplementation with a vitamin D, calcium and leucine', 'vitamin D, calcium and leucine-enriched whey protein medical nutrition drink', 'isocaloric placebo']","['kidney function deterioration nor symptoms of vitamin D or calcium toxicity', 'tolerated', 'Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium', 'glomerular filtration rate (eGFR', 'Safety and tolerability', 'eGFR change', 'Serum calcidiol and calcium']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0681013,A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity.,"[{'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Bauer', 'Affiliation': 'Center for Geriatric Medicine, University Heidelberg, Agaplesion Bethanien Krankenhaus Heidelberg, Heidelberg, Germany. Juergen.Bauer@bethanien-heidelberg.de.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mikušová', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Sjors', 'Initials': 'S', 'LastName': 'Verlaan', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology and Geriatrics, VU, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Brandt', 'Affiliation': 'Human Nutrition Research Centre, School of Agriculture, Food and Rural Development, Newcastle University Institute for Ageing, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lorenzo M', 'Initials': 'LM', 'LastName': 'Donini', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Maggio', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Parma, Italy.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mets', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Sander L J', 'Initials': 'SLJ', 'LastName': 'Wijers', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Jossie A', 'Initials': 'JA', 'LastName': 'Garthoff', 'Affiliation': 'Danone Food Safety Center, Utrecht, The Netherlands.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Luiking', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences/Clinical Nutrition and Metabolism, Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Aging clinical and experimental research,['10.1007/s40520-020-01519-x']
474,32064970,"Effects of a plant-based fatty acid supplement and a powdered fruit, vegetable and berry juice concentrate on omega-3-indices and serum micronutrient concentrations in healthy subjects.","The major aim of this controlled, randomised, open-labelled, parallel-grouped, clinical trial was to investigate whether supplementation with different dosages of omega-3 fatty acids (0.5 g/d and 1 g/d) from a plant-based fatty acid supplement affected omega-3-indices (O3I) in well-nourished, healthy people. In addition, the combined ingestion of the plant-based fatty acid supplement, together with an encapsulated fruit, vegetable and berry (FVB) juice powder concentrate, was applied in order to observe the absorption of certain micronutrients and to examine some aspects related to the safe consumption of the products. The data demonstrate that the intake of only 0.5 g/day of omega-3 fatty acids from of a vegan supplement was able to increase the O3I significantly after 8 and 16 weeks. The combined ingestion with the FVB supplement concurrently increased serum concentrations of specific vitamins and carotenoids without effects on hepatic, kidney and thyroid function or changes in blood lipids.",2020,"The combined ingestion with the FVB supplement concurrently increased serum concentrations of specific vitamins and carotenoids without effects on hepatic, kidney and thyroid function or changes in blood lipids.",['healthy subjects'],"['FVB supplement', 'omega-3 fatty acids', 'plant-based fatty acid supplement and a powdered fruit, vegetable and berry juice concentrate']","['hepatic, kidney and thyroid function or changes in blood lipids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",,0.019226,"The combined ingestion with the FVB supplement concurrently increased serum concentrations of specific vitamins and carotenoids without effects on hepatic, kidney and thyroid function or changes in blood lipids.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Dams', 'Affiliation': 'Otto Loewi Research Center, Division of Immunology and Pathophysiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Holasek', 'Affiliation': 'Otto Loewi Research Center, Division of Immunology and Pathophysiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Tsiountsioura', 'Affiliation': 'Green Beat - Institute of Nutrient Research and Sport Nutrition, Graz, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Edelsbrunner', 'Affiliation': 'Green Beat - Institute of Nutrient Research and Sport Nutrition, Graz, Austria.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Dietz', 'Affiliation': 'Institute of Occupational, Social and Environmental Medicine, University Medical Centre, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Koefeler', 'Affiliation': 'Core Facility Mass Spectrometry, ZMF, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Daniela-Eugenia', 'Initials': 'DE', 'LastName': 'Malliga', 'Affiliation': 'Green Beat - Institute of Nutrient Research and Sport Nutrition, Graz, Austria.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Gürbüz', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Meier-Allard', 'Affiliation': 'Otto Loewi Research Center, Division of Immunology and Pathophysiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Poncza', 'Affiliation': 'Otto Loewi Research Center, Division of Immunology and Pathophysiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Lackner', 'Affiliation': 'Otto Loewi Research Center, Division of Immunology and Pathophysiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Schwarzenberger', 'Affiliation': 'Otto Loewi Research Center, Division of Immunology and Pathophysiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Jansenberger', 'Affiliation': 'Green Beat - Institute of Nutrient Research and Sport Nutrition, Graz, Austria.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Lamprecht', 'Affiliation': 'Green Beat - Institute of Nutrient Research and Sport Nutrition, Graz, Austria.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1725960']
475,32162943,Parents' relationship maintenance as a buffer for the stress of their adolescent's type 1 diabetes.,"Having an adolescent with Type 1 diabetes (T1D) can be stressful for the entire family. This study examined the impact of parents' relationship maintenance on their ability to manage the conflict associated with their child's T1D, the parents' physiological health (inflammation), and the relationships within the family. Sixty couples and their adolescent children with T1D participated. The couples engaged in a stressful conversation about their child's T1D in their home, followed by random assignment to a 2-week intervention designed to increase the relationship maintenance in the marriage. Results from the home visit revealed that when husbands and wives received greater maintenance from each other the past month, they perceived less conflict when talking about their adolescent's T1D, which was associated with less relational load and lower levels of C-reactive protein (CRP). For wives, greater relationship maintenance was also directly associated with less relational load and lower CRP levels. In addition, the relationship maintenance received was directly and positively associated with parent-child relationship quality for fathers, but this association was mediated by interparental conflict for mothers. Finally, the 2-week intervention reduced parents' relational load and the number of stressful conversations and improved the mother-adolescent relationship but did not significantly reduce parents' CRP. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Finally, the 2-week intervention reduced parents' relational load and the number of stressful conversations and improved the mother-adolescent relationship but did not significantly reduce parents' CRP.",['Sixty couples and their adolescent children with T1D participated'],[],"['relational load and lower levels of C-reactive protein (CRP', 'relational load and lower CRP levels', ""parents' CRP"", ""parents' relational load and the number of stressful conversations""]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",60.0,0.0198287,"Finally, the 2-week intervention reduced parents' relational load and the number of stressful conversations and improved the mother-adolescent relationship but did not significantly reduce parents' CRP.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Afifi', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zamanzadeh', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'Sharde', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ersig', 'Affiliation': 'School of Nursing.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tsalikian', 'Affiliation': 'University of Iowa Hospitals and Clinics.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Acevedo Callejas', 'Affiliation': 'Department of Communication Arts and Sciences.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000634']
476,31861349,"Prevention of Acute Upper Respiratory Infections by Consumption of Catechins in Healthcare Workers: A Randomized, Placebo-Controlled Trial.","Catechins, phytochemicals contained mainly in green tea, exhibit antiviral activity against various acute infectious diseases experimentally. Clinical evidence supporting these effects, however, is not conclusive. We performed a placebo-controlled, single-blind, randomized control trial to evaluate the clinical effectiveness of consumption of catechins-containing beverage for preventing acute upper respiratory tract infections (URTIs). Two hundred and seventy healthcare workers were randomly allocated to high-catechin (three daily doses of 57 mg catechins and 100 mg xanthan gum), low-catechin (one daily dose of 57 mg catechins and 100 mg xanthan gum), or placebo (0 mg catechins and 100 mg xanthan gum) group. Subjects consumed a beverage with or without catechins for 12 weeks from December 2017 through February 2018. The primary endpoint was incidence of URTIs compared among groups using a time-to-event analysis. A total of 255 subjects were analyzed (placebo group n = 86, low-catechin group n = 85, high catechin group n = 84). The URTI incidence rate was 26.7% in the placebo group, 28.2% in the low-catechin group, and 13.1% in the high-catechin group (log rank test,  p   =  0.042). The hazard ratio (95% confidence interval (CI)) with reference to the placebo group was 1.09 (0.61-1.92) in the low-catechin group and 0.46 (0.23-0.95) in the high-catechin group. These findings suggest that catechins combined with xanthan gum protect against URTIs.",2019,"The URTI incidence rate was 26.7% in the placebo group, 28.2% in the low-catechin group, and 13.1% in the high-catechin group (log rank test,  p   =  0.042).","['Acute Upper Respiratory Infections by Consumption of Catechins in Healthcare Workers', 'Two hundred and seventy healthcare workers', 'A total of 255 subjects were analyzed (placebo group n = 86, low-catechin group n = 85, high catechin group n = 84']","['placebo', 'high-catechin (three daily doses of 57 mg catechins and 100 mg xanthan gum), low-catechin (one daily dose of 57 mg catechins and 100 mg xanthan gum), or placebo (0 mg catechins and 100 mg xanthan gum', 'Placebo', 'catechins-containing beverage']","['incidence of URTIs', 'URTI incidence rate', 'hazard ratio']","[{'cui': 'C0264222', 'cui_str': 'Acute upper respiratory infection (disorder)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0078596', 'cui_str': 'xanthan gum'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",255.0,0.208077,"The URTI incidence rate was 26.7% in the placebo group, 28.2% in the low-catechin group, and 13.1% in the high-catechin group (log rank test,  p   =  0.042).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Furushima', 'Affiliation': 'Department of Drug Evaluation and Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Department of Drug Evaluation and Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Norikata', 'Initials': 'N', 'LastName': 'Takuma', 'Affiliation': 'White Cross Nursing Home, Tokyo 189-0021, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Iketani', 'Affiliation': 'Department of Drug Evaluation and Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Tomohito', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Biological Science Research Laboratories, Kao Corporation, Tokyo 131-8501, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsui', 'Affiliation': 'Biological Science Research Laboratories, Kao Corporation, Tokyo 131-8501, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Health Care Food Research Laboratories, Kao Corporation, Tokyo 131-8501, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Personal Healthcare Research Laboratories, Kao Corporation, Tokyo 131-8501, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Personal Healthcare Research Laboratories, Kao Corporation, Tokyo 131-8501, Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Hibi', 'Affiliation': 'Biological Science Research Laboratories, Kao Corporation, Tokyo 131-8501, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Department of Drug Evaluation and Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}]",Nutrients,['10.3390/nu12010004']
477,29468978,Comparing Effectiveness of a Combined Herbal Drug Based on Echium Amoenum with Citalopram in the Treatment of Major Depressive Disorder.,"BACKGROUND


According to new studies, only 60% of depressed patients respond to pharmaceutical treatment while suffering from their side effects. Natural products as adjuvant or alternative therapies should be examined to find safer and more effective ways to cope with depression.
OBJECTIVE


To find out the potential benefits of a combined herbal drug based on Echium amoenum compared with citalopram in the treatment of Major Depressive Disorder.
DESIGN AND SETTING


In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial.
INTERVENTION


Subjects were randomly assigned to receive Echium amoenum compound syrup (EACS) or citalopram tablet for 8 weeks.
OUTCOME MEASURES


The efficacy of treatments and recurrence of disease were surveyed and compared according to Hamilton depression rating scale at weeks 0, 4, 8, 12.
RESULTS


Patients in both groups of citalopram and EACS showed remarkable reduction in scores of Hamilton questionnaire. At the eighth week of treatment, the mean scores in EACS group were significantly lower than citalopram group (p-value = 0.03). 52% of patients suffered from various complications in citalopram group while just 12% of patients in EACS group reported few complications.
CONCLUSION


Clinical efficacy of this herbal drug was significantly higher than citalopram, and complications were also less and lower in EACS group. Further studies with larger groups and para-clinical assessments such as serologic tests and QEEG would improve our understanding of the impacts and mechanisms of EACS.",2019,"At the eighth week of treatment, the mean scores in EACS group were significantly lower than citalopram group (p-value = 0.03).","['In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5', 'Major Depressive Disorder']","['citalopram', 'EACS', 'Echium amoenum compound syrup (EACS) or citalopram tablet', 'citalopram and EACS', 'Citalopram']","['Hamilton depression rating scale', 'scores of Hamilton questionnaire', 'mean scores']","[{'cui': 'C3811913', 'cui_str': 'Psychiatry clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0331267', 'cui_str': 'Echium'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0248262,"At the eighth week of treatment, the mean scores in EACS group were significantly lower than citalopram group (p-value = 0.03).","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Anushiravani', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Manteghi', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghipur', 'Affiliation': 'Health Sciences Research Centre, Department of Biostatistics and Epidemiology, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Eslami', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Current drug discovery technologies,['10.2174/1570163815666180219115844']
478,31878131,Changes in Food Cravings and Eating Behavior after a Dietary Carbohydrate Restriction Intervention Trial.,"Compared to low-fat diets, low-carbohydrate (CHO) diets cause weight loss (WL) over a faster time frame; however, it is unknown how changes in food cravings and eating behavior contribute to this more rapid WL in the early phases of dieting. We hypothesized that reductions in food cravings and improved eating behaviors would be evident even after a relatively short (4-week) duration of CHO-restriction, and that these changes would be associated with WL. Adult participants ( n  = 19, 53% males, mean ± SD: BMI = 34.1 ± 0.8 kg/m 2 ; age 40.6 ± 1.9 years) consumed a CHO-restricted diet (14% CHO, 58% fat, 28% protein) for 4 weeks. Before and after the intervention, specific and total cravings were measured with the Food Craving Inventory (FCI) and eating behaviors assessed with the Three-Factor Eating questionnaire. Food cravings were significantly reduced at week 4, while women had significantly greater reductions in sweet cravings than men. Dietary restraint was significantly increased by 102%, while disinhibiton and hunger scores were reduced (17% and 22%, respectively,  p  < 0.05). Changes in cravings were unrelated to changes in body weight except for the change in high-fat cravings where those who lost the most weight experienced the least reductions in fat cravings ( r  = -0.458,  p  = 0.049). Changes in dietary restraint were inversely related to several FCI subscales. A short-term, low-CHO diet was effective in reducing food cravings. These data suggest that in subjects that have successfully lost weight on a low-CHO diet, those who craved high-fat foods at the onset were able to satisfy their cravings-potentially due to the high-fat nature of this restricted diet.",2019,Changes in cravings were unrelated to changes in body weight except for the change in high-fat cravings where those who lost the most weight experienced the least reductions in fat cravings (,"['Adult participants ( n  = 19, 53% males, mean ± SD: BMI = 34.1 ± 0.8 kg/m 2 ; age 40.6 ± 1.9 years) consumed a CHO-restricted diet (14% CHO, 58% fat, 28% protein) for 4 weeks']",['low-CHO diet'],"['Dietary restraint', 'fat cravings', 'Food Craving Inventory (FCI) and eating behaviors', 'food cravings', 'sweet cravings', 'disinhibiton and hunger scores', 'Food Cravings and Eating Behavior', 'Food cravings', 'specific and total cravings', 'food cravings and improved eating behaviors', 'several FCI subscales']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0194474,Changes in cravings were unrelated to changes in body weight except for the change in high-fat cravings where those who lost the most weight experienced the least reductions in fat cravings (,"[{'ForeName': 'Katherene O-B', 'Initials': 'KO', 'LastName': 'Anguah', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Majid M', 'Initials': 'MM', 'LastName': 'Syed-Abdul', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Jacome-Sosa', 'Affiliation': 'Department of Internal Medicine, Division of Nutritional Science, Washington University School of Medicine, St. Louis, MO 63110, USA.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Heimowitz', 'Affiliation': 'Atkins Nutritionals, Inc., Denver, CO 80202, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Cox', 'Affiliation': 'Deoartment of Nutrition, West Chester University, West Chester, PA 19383, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Parks', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO 65211, USA.'}]",Nutrients,['10.3390/nu12010052']
479,29526281,Outcomes of Counseling after Education about Carrier Results: A Randomized Controlled Trial.,"In-person education and counseling for all people receiving genetic results is the predominant model of disclosure but is challenged by the growing volume of low-impact results generated by sequencing. Evidence suggests that web-based tools may be as effective as in-person counseling at educating individuals about their low-impact results. However, the effects of counseling have not been assessed. To evaluate its utility, carrier results were returned to 459 post-reproductive participants from the ClinSeq cohort within a randomized controlled trial. Participants received education and were randomized to receive counseling or not. Primary outcomes included risk worry, test-related positive experiences, attitudes, and decisional conflict. Secondary outcomes were satisfaction, preferences, and counseling value. There were no differences between participants who received counseling and those who did not in the primary outcomes. Participants who received counseling were more satisfied than those who did not (x¯ = 10.2 and 9.5, respectively, p < 0.002, range: 3-12), although overall satisfaction was high. Most participants (92%) randomized to counseling preferred it and valued it because it provided validation of their reactions and an opportunity for interpersonal interaction. Web-based tools address the challenge of returning low-impact results, and these data provide empiric evidence that counseling, although preferred and satisfying, is not critical to achieving desired outcomes.",2018,"Participants who received counseling were more satisfied than those who did not (x¯ = 10.2 and 9.5, respectively, p < 0.002, range: 3-12), although overall satisfaction was high.",['459 post-reproductive participants from the ClinSeq cohort within a randomized controlled trial'],[],"['satisfaction, preferences, and counseling value', 'overall satisfaction', 'risk worry, test-related positive experiences, attitudes, and decisional conflict']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}]",,0.184104,"Participants who received counseling were more satisfied than those who did not (x¯ = 10.2 and 9.5, respectively, p < 0.002, range: 3-12), although overall satisfaction was high.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Lewis', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA. Electronic address: lewiskatie@mail.nih.gov.'}, {'ForeName': 'Kendall L', 'Initials': 'KL', 'LastName': 'Umstead', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Johnston', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Ilana M', 'Initials': 'IM', 'LastName': 'Miller', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Thompson', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Kristen P', 'Initials': 'KP', 'LastName': 'Fishler', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Leslie G', 'Initials': 'LG', 'LastName': 'Biesecker', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Biesecker', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA. Electronic address: lesb@mail.nih.gov.'}]",American journal of human genetics,['10.1016/j.ajhg.2018.02.009']
480,31339438,Effect of cost exposure on medical students' preferred mammography screening strategies: A randomized comparison.,"Introduction:  Many high value care educational interventions have focused on shaping clinical decision-making for individual patients. Few have investigated how trainees integrate cost information into recommendations within a public health context.  Methods:  Third-year medical students at the University of California San Francisco participated in a small group on benefits and harms of breast cancer screening. We randomly assigned half of small groups to view estimated total costs of different screening strategies. Students selected a screening strategy for coverage by a publicly funded program and one they would recommend to a hypothetical patient. We used the chi-square test for independence and chi-square test for trend to compare proportions.  Results:  A total of 267 third-year medical students participated. Exposure to costs was associated with selection of significantly less intensive screening strategies for coverage by a publicly funded program ( p  < 0.05). We found no significant differences in perspectives that involved recommendations for individual patients.  Discussion:  Students weigh cost considerations more heavily when making decisions about populations, rather than individual hypothetical patients. We suggest that it may be easier for students to relate cost considerations to populations. Initial curricular activities can be framed from this perspective with subsequent activities focusing on individual patient care.",2019,Exposure to costs was associated with selection of significantly less intensive screening strategies for coverage by a publicly funded program ( p  < 0.05).,"['Students selected a screening strategy for coverage by a publicly funded program and one they would recommend to a hypothetical patient', 'Methods:  Third-year medical students at the University of California San Francisco participated in a small group on benefits and harms of breast cancer screening', 'A total of 267 third-year medical students participated', 'medical students']",['mammography screening strategies'],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],,0.0182202,Exposure to costs was associated with selection of significantly less intensive screening strategies for coverage by a publicly funded program ( p  < 0.05).,"[{'ForeName': 'Clarice', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'University of California San Francisco School of Medicine (UCSF) , San Francisco , CA , USA.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Sawaya', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences and Department of Epidemiology and Biostatistics, University of California San Francisco School of Medicine (UCSF) , San Francisco , CA , USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'UCSF Center for Healthcare Value , San Francisco , CA , USA.'}]",Medical teacher,['10.1080/0142159X.2019.1636954']
481,32159376,The Impact of a Multipronged Intervention to Increase School Lunch Participation among Secondary School Students in an Urban Public School District.,"Introduction:  Schools meals offer a critical opportunity for improving youths' diets, particularly for economically disadvantaged students. We examine the impact of a multipronged intervention to increase middle and high school students' lunch participation in an urban school district.  Methods:  In school years 2015-2016 through 2017-2018, a quasi-experimental study was conducted in 24 secondary schools, half ( n  = 12) of which received the following intervention: cafeteria redesign, additional school lunch points-of-sale (mobile carts and vending machines), and teacher education.  Results:  From baseline to follow-up, lunch participation dropped 4.1% in intervention and 5.1% in comparison schools (difference-in-difference 1.0%, 95% CI 0.5-1.4). The overall decline in lunch participation occurred simultaneously with a drop-in free or reduced-price meal eligibility (from 72% to 58%) across all schools, which is likely related to changing local economic conditions, including a county-wide minimum wage increase that began in summer 2015. Among students eligible for free or reduced-price meals, participation decreased 1.8% in intervention and 4.9% in comparison schools (difference-in-difference 3.1%, 95% CI: 2.5-3.7), with a larger difference-in-difference seen in high schools (5.0%, 95% CI: 4.2-5.9) than middle schools (1.8%, 95% CI: 0.8-2.6).  Conclusions:  While this intervention demonstrated a modest, but significant relative increase in school lunch participation, the effect was not sufficient to halt large district-wide declines in participation during this study period. Given the significant time, money, and political capital required to implement the intervention, districts should carefully consider similar investments. Broader public policies or other changes to economic conditions that affect eligibility for means-tested benefits-in this case, a strengthening local economy coupled with an increased local minimum wage-may influence school lunch participation more than school-level interventions.",2020,"Among students eligible for free or reduced-price meals, participation decreased 1.8% in intervention and 4.9% in comparison schools (difference-in-difference 3.1%, 95% CI: 2.5-3.7), with a larger difference-in-difference seen in high schools (5.0%, 95% CI: 4.2-5.9) than middle schools (1.8%, 95% CI: 0.8-2.6).  ","['Secondary School Students in an Urban Public School District', ""middle and high school students' lunch participation in an urban school district"", 'economically disadvantaged students', 'In school years 2015-2016 through 2017-2018, a quasi-experimental study was conducted in 24 secondary schools, half ( n \u2009=\u200912) of which received the following']","['Multipronged Intervention', 'multipronged intervention', 'intervention: cafeteria redesign, additional school lunch points-of-sale (mobile carts and vending machines), and teacher education']",['school lunch participation'],"[{'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0871930', 'cui_str': 'Teacher Education'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}]",,0.0375799,"Among students eligible for free or reduced-price meals, participation decreased 1.8% in intervention and 4.9% in comparison schools (difference-in-difference 3.1%, 95% CI: 2.5-3.7), with a larger difference-in-difference seen in high schools (5.0%, 95% CI: 4.2-5.9) than middle schools (1.8%, 95% CI: 0.8-2.6).  ","[{'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Thompson', 'Affiliation': 'Division of Community Health Sciences, UC Berkeley School of Public Health, Berkeley, CA, USA.'}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Gosliner', 'Affiliation': 'Nutrition Policy Institute, UC Agriculture and Natural Resources, Berkeley, CA, USA.'}, {'ForeName': 'Lorrene', 'Initials': 'L', 'LastName': 'Ritchie', 'Affiliation': 'Nutrition Policy Institute, UC Agriculture and Natural Resources, Berkeley, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wobbekind', 'Affiliation': 'Student Nutrition Services, San Francisco Unified School District, San Francisco, CA, USA.'}, {'ForeName': 'Annie L', 'Initials': 'AL', 'LastName': 'Reed', 'Affiliation': 'Division of Community Health Sciences, UC Berkeley School of Public Health, Berkeley, CA, USA.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': ""O'Keefe"", 'Affiliation': 'Chief of Policy and Operations, San Francisco Unified School District, San Francisco, CA, USA.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Madsen', 'Affiliation': 'Division of Community Health Sciences, UC Berkeley School of Public Health, Berkeley, CA, USA.'}]",Childhood obesity (Print),['10.1089/chi.2019.0233']
482,30718622,Baduanjin exercise intervention for community adults at risk of ischamic stroke: A randomized controlled trial.,"The aim of current study was to assess the effects of Baduanjin exercise on cerebrovascular function, cardiac structure and cardiac function, static pulmonary function, traditional risk factors of CVD and the related psychological outcomes in older community adults at risk for ischaemic stroke. A randomized controlled trial was conducted in three community between November 2013 and October 2015. Older community-dwelling adults (N = 170) were randomly allocated into either a Baduanjin training (5 × 60 min/weekly) or control group who kept their unaltered lifestyle during a 12-week intervention period. Primary (cerebral haemodynamic parameters) and secondary outcomes (cardiac structure, cardiac function, static pulmonary function, traditional risk factors and the related psychological outcomes) were measured at baseline, after a 12-week intervention period and after an additional 12-week follow-up period. After the 12-week intervention period and additional 12-week follow-up period, the Baduanjin exercise group displayed significant changes in most cerebral haemodynamic parameters compared to the control group: lower systolic blood pressure, diastolic blood pressure, plasma total cholesterol levels, waist circumference, hip circumference and waist/hip ratio; and improved mood, self-confidence, self-esteem, quality of life and sleep quality. A supervised 12-week Baduanjin exercise intervention was effective and safe in modulating cerebral haemodynamics, reducing blood pressure and improving anthropometric parameters and related psychological outcomes in older community adults at risk for ischaemic stroke.",2019,"A supervised 12-week Baduanjin exercise intervention was effective and safe in modulating cerebral haemodynamics, reducing blood pressure and improving anthropometric parameters and related psychological outcomes in older community adults at risk for ischaemic stroke.","['three community between November 2013 and October 2015', 'community adults at risk of ischamic stroke', 'older community adults at risk for ischaemic stroke', 'Older community-dwelling adults (N\u2009=\u2009170']","['Baduanjin training (5\u2009×\u200960\u2009min/weekly) or control group who kept their unaltered lifestyle', 'Baduanjin exercise intervention', 'Baduanjin exercise']","['Primary (cerebral haemodynamic parameters) and secondary outcomes (cardiac structure, cardiac function, static pulmonary function, traditional risk factors and the related psychological outcomes', 'blood pressure and improving anthropometric parameters and related psychological outcomes', 'cerebrovascular function, cardiac structure and cardiac function, static pulmonary function, traditional risk factors of CVD', 'systolic blood pressure, diastolic blood pressure, plasma total cholesterol levels, waist circumference, hip circumference and waist/hip ratio; and improved mood, self-confidence, self-esteem, quality of life and sleep quality', 'cerebral haemodynamic parameters']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1272107', 'cui_str': 'Plasma total cholesterol level'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C4508986', 'cui_str': 'Improved mood'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",3.0,0.0252102,"A supervised 12-week Baduanjin exercise intervention was effective and safe in modulating cerebral haemodynamics, reducing blood pressure and improving anthropometric parameters and related psychological outcomes in older community adults at risk for ischaemic stroke.","[{'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zheng', 'Affiliation': 'College of Nursing and Health Management, Shanghai University of Medicine & Health Sciences, Shanghai, 201318, China.'}, {'ForeName': 'Bai', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Education, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Fujian Key Laboratory of Rehabilitation Technology, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Rehabilitation Technology, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China. cld@fjtcm.edu.cn.'}]",Scientific reports,['10.1038/s41598-018-37544-0']
483,30718625,Induced vergence-accommodation conflict reduces cognitive performance in the Stroop test.,"Interaction mechanisms between cognition and binocular motor control in reading saccades remain unclear. In this study we examine objectively saccades and fixations parameters during the Stroop test, involving three different levels of cognitive demand (reading, color denomination and interference). In addition, we experimentally induce accommodation and vergence conflicts during the different tasks. Twenty-one visually normal subjects (age 20.9 ± 1.45) performed the Stroop test in three different randomized conditions: a control normal viewing condition, a 16Δ base-out prism condition, and a -2.50D spherical lenses condition. Prisms and spherical lenses induced Vergence-Accommodation conflict. Eye movements were recorded with the Eyeseecam video-oculography device. The results show (1) longer fixation duration in the interference task than in the denomination task, and shorter fixation duration in the reading task; (2) a higher interference effect in the conflict induced conditions compared to the control condition; (3) a lower tolerance to prism induced conflict, with a higher destabilization of the binocular motor control of saccades and fixations. This suggests an interplay between vergence accommodation conflict and cognitive load: tolerance to the conflict seems to be lower in the more cognitively demanding interference Stroop task. The results consolidate the link between cognition and high quality of single binocular vision.",2019,"Twenty-one visually normal subjects (age 20.9 ± 1.45) performed the Stroop test in three different randomized conditions: a control normal viewing condition, a 16Δ base-out prism condition, and a -2.50D spherical lenses condition.",['Twenty-one visually normal subjects (age 20.9\u2009±\u20091.45'],"['control normal viewing condition, a 16Δ base-out prism condition, and a -2.50D spherical lenses condition']","['binocular motor control of saccades and fixations', 'Vergence-Accommodation conflict', 'cognitive demand (reading, color denomination and interference', 'fixation duration', 'shorter fixation duration', 'cognitive performance']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036019', 'cui_str': 'Saccadic Eye Movements'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",21.0,0.0172834,"Twenty-one visually normal subjects (age 20.9 ± 1.45) performed the Stroop test in three different randomized conditions: a control normal viewing condition, a 16Δ base-out prism condition, and a -2.50D spherical lenses condition.","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Daniel', 'Affiliation': 'IRIS Group, Physiopathologie de la Vision et Motricité Binoculaire CNRS FR3636, Université Paris Descartes, Paris, France. fdaniel.optometry@gmail.com.'}, {'ForeName': 'Zoï', 'Initials': 'Z', 'LastName': 'Kapoula', 'Affiliation': 'IRIS Group, Physiopathologie de la Vision et Motricité Binoculaire CNRS FR3636, Université Paris Descartes, Paris, France. zoi.kapoula@gmail.com.'}]",Scientific reports,['10.1038/s41598-018-37778-y']
484,32142578,Esthetics and Patient-Reported Outcomes of Implants Placed with Guided Bone Regeneration and Complete Native Bone: A Prospective Controlled Clinical Trial.,"PURPOSE


When encountering a buccal bone defect during implant placement, guided bone regeneration (GBR) is a well-accepted method for bone reconstruction. However, it is still unclear if the esthetic and patient-reported outcomes are comparable to implants placed in native bone. The purpose of this prospective trial was to compare implants placed with a GBR procedure for a small (≤ 4 mm) buccal defect with implants placed completely in native bone (control).
MATERIALS AND METHODS


Patients were allocated to the GBR group or control group during implant placement in the esthetic zone. Implants were placed after at least 12 weeks of healing of the extraction sockets. A buccal bone defect of ≤ 4 mm resulted in allocation to the GBR group. Follow-up was performed until 12 months after loading. Outcome measurements were as follows: esthetic scores, patient-reported outcome measurements, implant survival and complications, clinical indices, and radiographic measurements.
RESULTS


In total, 45 patients were included, of which 23 underwent a GBR procedure after implant placement, and in 22 patients no GBR was necessary. No significant differences in esthetic outcomes were seen between the two groups. At the final follow-up, a mean pink esthetic score (PES) of 7.8 (SD: 1.5) was seen for the GBR group and 8.4 (SD: 1.4) for the control group. Regarding the white esthetic score (WES), a mean of 9.1 (SD: 1.0) was found for both groups. Patients of both groups were equally satisfied with their mucosa and crown. A mean visual analog score (VAS) for the soft tissues of 8.6 (SD: 1.0) in the GBR group and 8.8 (SD: 0.9) for the control group was noted. A mean VAS of 9.2 (SD: 0.8) was noted for the crown in the GBR group and 8.6 (SD: 2.0) in the control group. Implant survival was 100%, and there were no significant differences in complications, plaque/bleeding/gingiva indices, width of attached mucosa, and marginal bone loss.
CONCLUSION


Implants placed in the esthetic zone with GBR or complete native bone coverage showed successful esthetic outcomes and satisfied patients with predictable clinical and radiographic parameters after more than 1 year of loading. Within the limits of this study, GBR for a small buccal bone defect seems to be a reliable technique with good esthetics and patient-reported outcomes.",2020,"Implant survival was 100%, and there were no significant differences in complications, plaque/bleeding/gingiva indices, width of attached mucosa, and marginal bone loss.
","['45 patients were included, of which 23 underwent a GBR procedure after implant placement, and in 22 patients no GBR was necessary', 'Patients', 'implants placed with a GBR procedure for a small (≤ 4 mm) buccal defect with implants placed completely in native bone (control']","['implant placement, guided bone regeneration (GBR', 'GBR group or control group during implant placement', 'Implants Placed with Guided Bone Regeneration and Complete Native Bone']","['mean visual analog score (VAS', 'esthetic scores, patient-reported outcome measurements, implant survival and complications, clinical indices, and radiographic measurements', 'white esthetic score (WES', 'Implant survival', 'mean pink esthetic score (PES', 'esthetic outcomes', 'successful esthetic outcomes', 'complications, plaque/bleeding/gingiva indices, width of attached mucosa, and marginal bone loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",45.0,0.118369,"Implant survival was 100%, and there were no significant differences in complications, plaque/bleeding/gingiva indices, width of attached mucosa, and marginal bone loss.
","[{'ForeName': 'Brend P', 'Initials': 'BP', 'LastName': 'Jonker', 'Affiliation': ''}, {'ForeName': 'Eppo B', 'Initials': 'EB', 'LastName': 'Wolvius', 'Affiliation': ''}, {'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'van der Tas', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tahmaseb', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Pijpe', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7751']
485,32034016,"Neurokinin-1 antagonist orvepitant for EGFRI-induced pruritus in patients with cancer: a randomised, placebo-controlled phase II trial.","OBJECTIVE


To evaluate the efficacy of orvepitant (10 or 30 mg given once daily, orally for 4 weeks), a neurokinin-1 receptor antagonist, compared with placebo in reducing the intensity of epidermal growth factor receptor inhibitor (EGFRI)-induced intense pruritus.
DESIGN


Randomised, double-blind, placebo-controlled clinical trial.
SETTING


15 hospitals in Italy and five hospitals in the UK.
PARTICIPANTS


44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment.
INTERVENTION


30 or 10 mg orvepitant or placebo tablets once daily for 4 weeks (randomised 1:1:1).
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary endpoint was change from baseline in mean patient-recorded numerical rating scale (NRS) score (over the last three recordings) at week 4. Secondary outcome measures were NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus.
RESULTS


The trial was terminated early because of recruitment challenges; only 44 of the planned 90 patients were randomised. All patients were analysed for efficacy and safety. Mean NRS score change from baseline to week 4 was -2.78 (SD: 2.64) points in the 30 mg group, -3.04 (SD: 3.06) points in the 10 mg group and -3.21 (SD: 1.77) points in the placebo group; the difference between orvepitant and placebo was not statistically significant. No safety signal was detected. Adverse events related to orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis) were all of mild or moderate severity.
CONCLUSIONS


Orvepitant was safe and well tolerated. No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint. A number of explanations for this outcome are possible.
TRIAL REGISTRATION NUMBER


EudraCT2013-002763-25.",2020,No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint.,"['patients with cancer', '15 hospitals in Italy and five hospitals in the UK', '44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment']","['placebo', 'Neurokinin-1 antagonist orvepitant']","['mean patient-recorded numerical rating scale (NRS) score', 'orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis', 'efficacy and safety', 'Mean NRS score change', 'NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus', 'safe and well tolerated', 'safety signal', 'NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C2983799', 'cui_str': 'orvepitant'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2983799', 'cui_str': 'orvepitant'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4274441', 'cui_str': 'Verbal Rating Scale score'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",44.0,0.759463,No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint.,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vincenzi', 'Affiliation': 'Medical Oncology, Universita Campus Bio-Medico di Roma Facolta di Medicina e Chirurgia, Roma, Italy.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Trower', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK mike.trower@nerretherapeutics.com.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Adnovate Clinical Development Strategies, East Sussex, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Guglielmini', 'Affiliation': 'Oncology Unit, ASO SS Antonio e Biagio e C Arrigo, Alessandria, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Harris', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Biometrics Division, Cromsource, Stirling, UK.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Emiliangelo', 'Initials': 'E', 'LastName': 'Ratti', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tonini', 'Affiliation': 'Medical Oncology, Universita Campus Bio-Medico di Roma Facolta di Medicina e Chirurgia, Roma, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Idfac, Devon, UK.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Ständer', 'Affiliation': 'Center for Chronic Pruritus, University Hospital Münster, Münster, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-030114']
486,31324487,Effect of a school-based hand hygiene program for Malawian children: A cluster randomized controlled trial.,"BACKGROUND


Proper handwashing technique can reduce the mortality of a child. This study aimed to evaluate the impact of a school-based hand hygiene program on the handwashing compliance of children and school absenteeism in Southern Africa.
METHODS


We conducted a 2-arm cluster randomized trial in which 6 private primary schools were allocated randomly to either intervention (3 schools) or control (3 schools) groups. The intervention group consisted of implementing a series of planned activities and measures of hand hygiene program over 9 months. Parameters of primary and secondary outcomes were estimated with generalized estimating equations.
RESULTS


There were no significant between-group differences in demographic characteristics. The knowledge scores in the intervention group were significantly higher than the scores in the control group, and the technique scores in the intervention group were significantly higher than the scores in the control group after baseline. Further, after the third month, the cleanliness scores in the intervention group were significantly higher than the scores in the control group. In addition, the number of sick leave days decreased in the intervention group.
CONCLUSIONS


The impact of the school-based hand hygiene program was positive. It can be used in both the planning and development of a hand hygiene protocol to increase the handwashing compliance rate of schoolchildren and to reduce school absenteeism in developing countries.",2019,"The knowledge scores in the intervention group were significantly higher than the scores in the control group, and the technique scores in the intervention group were significantly higher than the scores in the control group after baseline.","['Malawian children', '6 private primary schools', 'children and school absenteeism in Southern Africa']",['school-based hand hygiene program'],"['cleanliness scores', 'demographic characteristics', 'knowledge scores', 'number of sick leave days', 'technique scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0001746', 'cui_str': 'Africa, Southern'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",,0.0363438,"The knowledge scores in the intervention group were significantly higher than the scores in the control group, and the technique scores in the intervention group were significantly higher than the scores in the control group after baseline.","[{'ForeName': 'Balwani Chingatichifwe', 'Initials': 'BC', 'LastName': 'Mbakaya', 'Affiliation': ""St John's College of Nursing & Midwifery, Mzuzu, Malawi, South Africa.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'World Health Organization Collaborating Centre for Community Health Services, School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Regina Lai Tong', 'Initials': 'RLT', 'LastName': 'Lee', 'Affiliation': 'Faculty of Health and Medicine, School of Nursing and Midwifery, University of Newcastle, Callaghan, NSW, Australia. Electronic address: Regina.L.Lee@newcastle.edu.au.'}]",American journal of infection control,['10.1016/j.ajic.2019.06.009']
487,31594738,An Intervention to Increase Uptake of Cervical Cancer Screening Among Emergency Department Patients: Results of a Randomized Pilot Study.,"BACKGROUND


Emergency departments (EDs) have the potential to promote critical public and preventive health interventions. Cervical cancer (CC) screening has been a cornerstone of preventive health efforts for decades. Approximately 20% of U.S. women are not adherent with CC screening guidelines-considerably below the U.S. Federal Government's target. ED patients are disproportionately nonadherent with CC screening guidelines. The ED, therefore, is an optimal setting to target women with an intervention that promotes CC screening.
OBJECTIVES


To assess the feasibility and potential efficacy of an intervention, grounded in behavioral change theory, to promote uptake of CC screening among ED patients.
METHODS


Design: Randomized clinical trial pilot study; Patients: Women aged 21-65 years that were identified in the ED to be nonadherent with CC screening recommendations; Setting: Single center urban academic ED.
RESULTS


Among enrolled participants, 355 (79%) were determined to be adherent with screening recommendations and 95 (21%) were determined to be either nonadherent or have uncertain adherence. Among the nonadherent/uncertain group, 47 were randomized to the control condition (referral only) and 48 were randomized to the intervention condition. Thirty-six percent of participants in the control condition received or scheduled screening during the follow-up period. In the intervention condition, 43% received or scheduled screening during the follow-up period-a 19% relative improvement over the control condition.
CONCLUSION


This pilot study demonstrates feasibility and preliminary efficacy of a behavioral intervention to increase uptake of CC screening among ED patients.",2019,"In the intervention condition, 43% received or scheduled screening during the follow-up period-a 19% relative improvement over the control condition.
","['Design', ' Patients: Women aged 21-65\xa0years that were identified in the ED to be nonadherent with CC screening recommendations; Setting: Single center urban academic ED', 'ED patients', 'Emergency Department Patients', 'enrolled participants, 355 (79%) were determined to be adherent with screening recommendations and 95 (21%) were determined to be either nonadherent or have uncertain adherence']",['behavioral intervention'],['Increase Uptake of Cervical Cancer Screening'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",47.0,0.0577135,"In the intervention condition, 43% received or scheduled screening during the follow-up period-a 19% relative improvement over the control condition.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Adler', 'Affiliation': 'Department of Emergency Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Beau', 'Initials': 'B', 'LastName': 'Abar', 'Affiliation': 'Department of Emergency Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wood', 'Affiliation': 'Department of Emergency Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Bonham', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Rochester, Rochester, New York.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.07.021']
488,30895883,Assessment of Cognitive Training & Social Interaction in People with Mild to Moderate Dementia: A Pilot Study.,"Objectives : To evaluate the cognitive, neuropsychiatric, and quality of life outcomes of computer-based cognitive training and social interaction on people with mild to moderate dementia.  Methods : Ten individuals with dementia were recruited to complete a cognitive training regimen. They were randomly assigned to a high social interaction (HSI) group (n = 5) and low social interaction (LSI) group (n = 5). Eight of the original 10 participants completed the cognitive training and were evaluated on cognitive abilities, neuropsychiatric symptoms (NPS), and quality of life (QoL).  Results : Mean scores for the HSI group increased on cognitive assessments, where mean scores for the LSI group saw decline, or stability. There was an overall reduction in the frequency and severity of NPS presentation in both the HSI and LSI group. Mixed results were found for mean changes in QoL.  Discussion : These results support the idea of social interaction influencing cognitive outcomes, cognitive training influencing NPS, and both social interaction and cognitive training influencing QoL. The findings illustrate the feasibility and importance of incorporating social activity to computerized cognitive training for people with dementia.  Clinical Implications : Cognitive training that incorporates social interaction may be a promising intervention for individuals with dementia experiencing NPS.",2019,"Mean scores for the HSI group increased on cognitive assessments, where mean scores for the LSI group saw decline, or stability.","['people with mild to moderate dementia', 'People with Mild to Moderate Dementia', 'individuals with dementia experiencing NPS', 'Ten individuals with dementia were recruited to complete a cognitive training regimen', 'people with dementia']","['computerized cognitive training', 'Cognitive training', 'high social interaction (HSI) group (n\xa0=\xa05) and low social interaction (LSI', 'Cognitive Training & Social Interaction', 'cognitive training', 'computer-based cognitive training and social interaction']","['Mean scores', 'frequency and severity of NPS presentation', 'cognitive outcomes, cognitive training influencing NPS, and both social interaction and cognitive training influencing QoL', 'cognitive abilities, neuropsychiatric symptoms (NPS), and quality of life (QoL']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0034380'}]",10.0,0.0139795,"Mean scores for the HSI group increased on cognitive assessments, where mean scores for the LSI group saw decline, or stability.","[{'ForeName': 'Hillary J', 'Initials': 'HJ', 'LastName': 'Rouse', 'Affiliation': 'a School of Aging Studies , University of South Florida , Tampa , FL , USA.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Small', 'Affiliation': 'a School of Aging Studies , University of South Florida , Tampa , FL , USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Faust', 'Affiliation': 'b Department of Psychological Science , University of North Carolina at Charlotte , Charlotte , NC , USA.'}]",Clinical gerontologist,['10.1080/07317115.2019.1590489']
489,30821649,Telephone-Delivered Cognitive Behavioural Therapy for Treating Symptoms of Anxiety and Depression in Parkinson's Disease: A Pilot Trial.,"Objectives : To determine the feasibility, acceptability and initial efficacy of telephone-delivered cognitive behavioral therapy (CBT) for the treatment of anxiety and depressive symptoms in people with Parkinson's disease.  Methods : A small randomized controlled trial compared telephone-based CBT to waitlist control. Eleven participants aged >50 years with Parkinson's disease and anxiety and/or depressive symptoms above recommended clinical cut-offs, were randomized to one of two conditions. Participants completed self-report measures of symptom severity and quality of life. Their carers were invited to participate and completed self-reported measures of symptoms and carer burden. At the end of the 10-week intervention period, participants and carers were reassessed on baseline measures, and again one month later.  Results : The CBT program was associated with significantly reduced depressive symptoms (Cohen's  d =  .90) at post-treatment with gains maintained at one-month follow-up. Anxiety symptom decreases (Cohen's  d  = 0.36) were not statistically different. Waitlist was associated with significantly worsened anxiety. Carer symptoms also reduced with CBT. No changes on quality of life were found. Good acceptability and feedback was received.  Conclusions : Telephone-based CBT reduced symptoms of depression in participants with Parkinson's disease but not anxiety.  Clinical Implications : Telephone-based CBT is a promising treatment option.",2019,The CBT program was associated with significantly reduced depressive symptoms (Cohen's  d =  .90) at post-treatment with gains maintained at one-month follow-up.,"[""participants with Parkinson's disease but not anxiety"", ""people with Parkinson's disease"", ""Parkinson's Disease"", ""Eleven participants aged >50\xa0years with Parkinson's disease and anxiety and/or depressive symptoms above recommended clinical cut-offs""]","['Telephone-Delivered Cognitive Behavioural Therapy', 'telephone-delivered cognitive behavioral therapy (CBT', 'Telephone-based CBT', 'telephone-based CBT']","['symptom severity and quality of life', 'depressive symptoms', 'feasibility, acceptability and initial efficacy', 'Carer symptoms', 'quality of life', 'worsened anxiety', 'anxiety and depressive symptoms', 'Anxiety symptom decreases']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C1518543', 'cui_str': 'Off (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",11.0,0.040278,The CBT program was associated with significantly reduced depressive symptoms (Cohen's  d =  .90) at post-treatment with gains maintained at one-month follow-up.,"[{'ForeName': 'Viviana M', 'Initials': 'VM', 'LastName': 'Wuthrich', 'Affiliation': 'a Centre for Emotional Health, Department of Psychology , Macquarie University , Sydney , Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'a Centre for Emotional Health, Department of Psychology , Macquarie University , Sydney , Australia.'}]",Clinical gerontologist,['10.1080/07317115.2019.1580811']
490,31481106,"A multicenter randomized, double-blind, placebo-controlled pilot study to assess the efficacy and safety of riociguat in systemic sclerosis-associated digital ulcers.","BACKGROUND


To determine the effect of riociguat, an oral, selective soluble guanylate cyclase stimulator, on the net digital ulcer (DU) burden in systemic sclerosis (SSc).
METHODS


Participants with SSc-related active or painful indeterminate DUs were recruited in a multicenter, double-blind, randomized, placebo-controlled, proof-of-concept trial. Eligible participants were required to have at least one visible, active ischemic DU or painful indeterminate DU at screening, located at or distal to the proximal interphalangeal joint and that developed or worsened within 8 weeks prior to screening. Participants were randomized 1:1 to placebo or riociguat in individualized doses (maximum of 2.5 mg three times daily) during an 8-week titration period, followed by an 8-week stable dosing period. This was followed by an optional 16-week open-label extension phase for participants with active DU/reoccurrence of DUs within 1 month of the end of the main treatment phase. The primary endpoint was the change from baseline to week 16 in net ulcer burden (NUB), analyzed using ANCOVA. Other endpoints included plasma biomarkers and proportion of participants with treatment-emergent adverse events (AEs).
RESULTS


Seventeen participants (eight placebo, nine riociguat) were randomized at five centers. Six participants in each group transitioned to the open-label extension. Baseline characteristics were comparable between the treatment groups, except participants randomized to placebo were older and had longer disease duration (p < 0.05). At baseline, the mean (SD) NUB was 2.5 (2.0) in the placebo and 2.4 (1.4) in the riociguat. No significant treatment difference was observed in the change from baseline to 16 weeks in NUB (adjusted mean treatment difference - 0.24, 95% CI (- 1.46, 0.99), p = 0.70). Four participants experienced five serious AE (four in riociguat and one in placebo); none was considered related to study medication. Statistically significant elevation of cGMP was observed at 16 weeks in the riociguat group (p = 0.05); no other biomarkers showed significant changes. In the open-label extension, participants in the riociguat-riociguat arm had complete healing of their DUs.
CONCLUSION


In participants with SSc-DU, treatment with riociguat did not reduce the number of DU net burden compared with placebo at 16 weeks. Open-label extension suggests that longer duration is needed to promote DU healing, which needs to be confirmed in a new trial.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02915835 . Registered on September 27, 2016.",2019,Statistically significant elevation of cGMP was observed at 16 weeks in the riociguat group (p = 0.05); no other biomarkers showed significant changes.,"['participants with active DU/reoccurrence of DUs within 1\u2009month of the end of the main treatment phase', 'Seventeen participants (eight placebo, nine riociguat', 'systemic sclerosis (SSc', 'Participants with SSc-related active or painful indeterminate DUs', 'Eligible participants were required to have at least one visible, active ischemic DU or painful indeterminate DU at screening, located at or distal to the proximal interphalangeal joint and that developed or worsened within 8\u2009weeks prior to screening', 'systemic sclerosis-associated digital ulcers']","['placebo', 'placebo or riociguat', 'riociguat']","['elevation of cGMP', 'number of DU net burden', 'NUB', 'change from baseline to week 16 in net ulcer burden (NUB), analyzed using ANCOVA', 'mean (SD) NUB', 'efficacy and safety', 'complete healing of their DUs', 'longer disease duration', 'plasma biomarkers and proportion of participants with treatment-emergent adverse events (AEs', 'five serious AE']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate (qualifier value)'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",17.0,0.740118,Statistically significant elevation of cGMP was observed at 16 weeks in the riociguat group (p = 0.05); no other biomarkers showed significant changes.,"[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Nagaraja', 'Affiliation': 'Division of Rheumatology/Department of Internal Medicine, University of Michigan Scleroderma Program, Suite 7C27, 300 North Ingalls Street, SPC 5422, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Bush', 'Affiliation': 'Division of Rheumatology/Department of Internal Medicine, University of Michigan Scleroderma Program, Suite 7C27, 300 North Ingalls Street, SPC 5422, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Pei-Suen', 'Initials': 'PS', 'LastName': 'Tsou', 'Affiliation': 'Division of Rheumatology/Department of Internal Medicine, University of Michigan Scleroderma Program, Suite 7C27, 300 North Ingalls Street, SPC 5422, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Robyn T', 'Initials': 'RT', 'LastName': 'Domsic', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lafyatis', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Division of Rheumatology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Gordon', 'Affiliation': 'Division of Rheumatology, Hospital of Special Surgery, New York, NY, USA.'}, {'ForeName': 'Virginia D', 'Initials': 'VD', 'LastName': 'Steen', 'Affiliation': 'Division of Rheumatology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Division of Rheumatology/Department of Internal Medicine, University of Michigan Scleroderma Program, Suite 7C27, 300 North Ingalls Street, SPC 5422, Ann Arbor, MI, 48109, USA. khannad@med.umich.edu.'}]",Arthritis research & therapy,['10.1186/s13075-019-1979-7']
491,31409541,Cost-effectiveness of a collaborative dementia care management-Results of a cluster-randomized controlled trial.,"INTRODUCTION


The purpose of this study was to determine the cost-effectiveness of collaborative dementia care management (DCM).
METHODS


The cost-effectiveness analysis was based on the data of 444 patients of a cluster-randomized, controlled trial, conceptualized to evaluate a collaborative DCM that aimed to optimize treatment and care in dementia. Health-care resource use, costs, quality-adjusted life years (QALYs), and incremental cost per QALY gained were measured over a 24-month time horizon.
RESULTS


DCM increased QALYs (+0.05) and decreased costs (-569€) due to a lower hospitalization and a delayed institutionalization (7 months) compared with usual care. The probability of DCM being cost-effective was 88% at willingness-to-pay thresholds of 40,000€ per QALY gained and higher in patients living alone compared to those not living alone (96% vs. 26%).
DISCUSSION


DCM is likely to be a cost-effective strategy in treating dementia and thus beneficial for public health-care payers and patients, especially for those living alone.",2019,"RESULTS


DCM increased QALYs (+0.05) and decreased costs (-569€) due to a lower hospitalization and a delayed institutionalization (7 months) compared with usual care.",['444 patients'],"['collaborative dementia care management', 'collaborative dementia care management (DCM']","['Cost-effectiveness', 'delayed institutionalization', 'probability of DCM being cost-effective', 'Health-care resource use, costs, quality-adjusted life years (QALYs), and incremental cost per QALY gained', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",444.0,0.098162,"RESULTS


DCM increased QALYs (+0.05) and decreased costs (-569€) due to a lower hospitalization and a delayed institutionalization (7 months) compared with usual care.","[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Michalowsky', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany; Department of Health Research Methods, Evidence and Impact (formerly Clinical Epidemiology and Biostatistics), McMaster University, Hamilton, Canada. Electronic address: bernhard.michalowsky@dzne.de.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact (formerly Clinical Epidemiology and Biostatistics), McMaster University, Hamilton, Canada; Program for Health Economics and Outcome Measures (PHENOM), Hamilton, Canada.'}, {'ForeName': 'Tilly', 'Initials': 'T', 'LastName': 'Eichler', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany; Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Kaczynski', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Kilimann', 'Affiliation': 'Department of Psychosomatic Medicine, University Hospital Rostock, Rostock, Germany; German Centre for Neurodegenerative Diseases (DZNE), Rostock, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Teipel', 'Affiliation': 'Department of Psychosomatic Medicine, University Hospital Rostock, Rostock, Germany; German Centre for Neurodegenerative Diseases (DZNE), Rostock, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Wucherer', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Zwingmann', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany.'}, {'ForeName': 'Jochen René', 'Initials': 'JR', 'LastName': 'Thyrian', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hoffmann', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Greifswald, Germany; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald (UMG), Greifswald, Germany.'}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1016/j.jalz.2019.05.008']
492,32151503,Modified constraint-induced movement therapy during hospitalization in children with perinatal brachial plexus palsy: A randomized controlled trial.,"STUDY DESIGN


Prospective single-blind, randomized controlled study.
INTRODUCTION


Children with perinatal brachial plexus palsy (PBPP) have motion limitations in the affected upper extremity. Modified constraint-induced movement therapy (mCIMT) is one of the treatment options used for the improvement of the function of the affected limb.
PURPOSE OF THE STUDY


The purpose of this study was to compare the effect of mCIMT and conventional therapy in improving active range of motion (ROM) and functional use of the affected upper extremity in children with PBPP with injuries to upper and middle trunks in the hospital environment.
MATERIALS


26 patients received conventional rehabilitation program (control group) and 13 patients participated in a mCIMT program (study group). Children had a mean age 56.3 months (range 4-10 years). The mCIMT included 1 hour therapy sessions emphasizing the affected arm use for 14 consecutive days during hospitalization. Their normal arm was also constrained for 6 hour per day. All the patients were assessed at the baseline, one day, one month, and three months after completion of therapy using active ROM, active movement scale, hand dynamometer, box and blocks test.
RESULTS


The mCIMT group improved more than the control group in shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function.
CONCLUSION


mCIMT has a potential to promote functional gains for children with PBPP; this approach should be widely applied within routine clinical practice.",2020,"The mCIMT group improved more than the control group in shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function.
","['Children had a mean age 56.3 months (range 4-10 years', 'Children with perinatal brachial plexus palsy (PBPP', '26 patients received', 'children with PBPP with injuries to upper and middle trunks in the hospital environment', 'children with PBPP', 'children with perinatal brachial plexus palsy']","['conventional rehabilitation program (control group) and 13 patients participated in a mCIMT program', 'Modified constraint-induced movement therapy', 'mCIMT and conventional therapy', 'Modified constraint-induced movement therapy (mCIMT', 'mCIMT']","['active range of motion (ROM', 'shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function', 'active ROM, active movement scale, hand dynamometer, box and blocks test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006090', 'cui_str': 'Brachial Plexus'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",26.0,0.0262725,"The mCIMT group improved more than the control group in shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function.
","[{'ForeName': 'Beyhan', 'Initials': 'B', 'LastName': 'Eren', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Marmaris State Hospital, Muğla, Turkey. Electronic address: beyhan89@yahoo.com.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Karadağ Saygı', 'Affiliation': 'Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Tokgöz', 'Affiliation': 'Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akdeniz Leblebicier', 'Affiliation': 'Physical Medicine and Rehabilitation Department, School of Medicine, Dumlupınar University, Kütahya, Turkey.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.008']
493,32142580,Satisfaction and Oral Health-Related Quality of Life of Different Attachments Used for Implant-Retained Overdentures in Subjects with Resorbed Mandibles: A Crossover Trial.,"PURPOSE


The aim of this crossover study was to evaluate patient satisfaction and oral health related-quality of life (OHRQoL) with different connectors used for implant-retained overdentures in subjects with resorbed mandibles.
MATERIALS AND METHODS


Eighteen edentulous patients with atrophied mandibular bone received traditional maxillary and mandibular dentures (control). After 3 months, two implants were inserted in the canine regions. Three months later, each patient received the following overdentures using a crossover design: (1) bar overdentures, (2) telescopic overdentures, and (3) stud overdentures. Patient satisfaction (primary outcome) was measured by visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months of using conventional dentures, bar overdentures, telescopic overdentures, and stud overdentures.
RESULTS


For all questionnaires, conventional dentures recorded significantly lower satisfaction than implant overdentures. Stud overdentures showed significantly higher satisfaction with maxillary denture comfort, self-consciousness, and feeling that the prosthesis is a part of the patient compared with other attachments. Bar and telescopic overdentures showed higher satisfaction during biting of hard and soft foods, while telescopic and stud overdentures showed higher satisfaction with oral hygiene. No significant differences between attachments regarding other VAS and OHIP-14 questions were noted.
CONCLUSION


Implant overdentures for subjects with mandibular bone resorption improved patient satisfaction and OHRQoL compared with traditional dentures regardless of the form of attachments. However, studs are more advantageous in terms of comfort with maxillary overdentures, self-consciousness, and feeling that the prosthesis is a part of the patient. Bar and telescopic attachments had more satisfaction during biting of soft and hard foods, while telescopic and stud attachments had more satisfaction with oral hygiene.",2020,"CONCLUSION


Implant overdentures for subjects with mandibular bone resorption improved patient satisfaction and OHRQoL compared with traditional dentures regardless of the form of attachments.","['subjects with resorbed mandibles', 'Eighteen edentulous patients with atrophied mandibular bone received traditional maxillary and mandibular dentures (control', 'Subjects with Resorbed Mandibles']",[],"['satisfaction with maxillary denture comfort, self-consciousness, and feeling that the prosthesis', 'VAS and OHIP-14 questions', 'patient satisfaction and OHRQoL', 'oral health impact profile (OHIP-14', 'Satisfaction and Oral Health-Related Quality of Life', 'visual analog scale (VAS', 'patient satisfaction and oral health related-quality of life (OHRQoL']","[{'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0029162'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",18.0,0.107818,"CONCLUSION


Implant overdentures for subjects with mandibular bone resorption improved patient satisfaction and OHRQoL compared with traditional dentures regardless of the form of attachments.","[{'ForeName': 'Fatma Fathe', 'Initials': 'FF', 'LastName': 'Mahanna', 'Affiliation': ''}, {'ForeName': 'Moustafa Abdou', 'Initials': 'MA', 'LastName': 'Elsyad', 'Affiliation': ''}, {'ForeName': 'Samah Ibrahim', 'Initials': 'SI', 'LastName': 'Mourad', 'Affiliation': ''}, {'ForeName': 'Heba Wageh', 'Initials': 'HW', 'LastName': 'Abozaed', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7869']
494,31531962,"Acceptability of escitalopram versus duloxetine in outpatients with depression who did not respond to initial second-generation antidepressants: Study protocol for a randomized, parallel-group, non-inferiority trial.","AIM


The purpose of this study is to compare acceptability of two second generation antidepressants for major depressive disorder patients who have not responded to the first antidepressant for current episode. We will investigate the treatment discontinuation rate and treatment adherence as well as incidence of adverse events in order to evaluate safety.
METHODS


This is a two-arm, three-phased randomized controlled trial in which independent assessors will be blinded while treating psychiatrists and patients remain unblinded to treatment allocation. Patients will be randomized to escitalopram or duloxetine in Step 1 (8 weeks), and when entering Step 2 (8 weeks), the drug will be switched to the other if the first one is not effective at the end of Step 1. The acceptability of the allocated drugs, improvements in depression from baseline, adverse events, and attrition rates will be recorded and assessed for up to 52 weeks, including the follow-up step.
RESULTS


It is going to be disseminated via our following reports or presentations.
CONCLUSIONS


This study will provide valuable information for clinicians who encounter patients who failed to respond to their first treatment.",2019,"The acceptability of the allocated drugs, improvements in depression from baseline, adverse events, and attrition rates will be recorded and assessed for up to 52 weeks, including the follow-up step.
","['clinicians who encounter patients who failed to respond to their first treatment', 'outpatients with depression who did not respond to initial second-generation antidepressants', 'major depressive disorder patients who have not responded to the first antidepressant for current episode']","['escitalopram or duloxetine', 'escitalopram versus duloxetine']","['depression from baseline, adverse events, and attrition rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.177592,"The acceptability of the allocated drugs, improvements in depression from baseline, adverse events, and attrition rates will be recorded and assessed for up to 52 weeks, including the follow-up step.
","[{'ForeName': 'Yuma', 'Initials': 'Y', 'LastName': 'Yokoi', 'Affiliation': 'Department of Psychiatry, National Center of Neurology and Psychiatry, National Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Keio University Hospital Clinical and Translational Research Center, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Psychiatry, National Center of Neurology and Psychiatry, National Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiaki A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Iwanami', 'Affiliation': 'Department of Psychiatry, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Keio University Hospital Clinical and Translational Research Center, Tokyo, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Nakagome', 'Affiliation': 'National Center of Neurology and Psychiatry, National Institute of Mental Health, Tokyo, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12078']
495,31481366,"Children and Young People's Health Partnership (CYPHP) Evelina London model of care: protocol for an opportunistic cluster randomised controlled trial (cRCT) to assess child health outcomes, healthcare quality and health service use.","INTRODUCTION


Children and young people (CYP) in many high-income settings have poor healthcare outcomes, especially those with long-term conditions (LTCs). Emergency and outpatient hospital service use is increasing unsustainably. To address these problems, the Children and Young People's Health Partnership (CYPHP) has developed and is evaluating an integrated model of care as part of a health systems strengthening programme across two boroughs of London, UK that are characterised by mixed ethnic populations and varying levels of deprivation. The CYPHP Evelina London model of care comprises proactive case-finding and triage, specialist clinics and transformative education and training for professionals working with CYP. Services are delivered by multidisciplinary health teams with an emphasis on increased coordination across primary, community and hospital settings and integration of physical and mental healthcare that accounts for the CYP's social context.
METHODS AND ANALYSIS


The phased roll out of the CYPHP Evelina London model allows an opportunistic population-based evaluation using a cluster randomised controlled trial design. Seventy general practices across two London boroughs, grouped into 23 clusters, were randomised to provide either the CYPHP model of care (n=11) or enhanced usual care (n=12).The evaluation will measure the impact of the CYPHP Evelina London model of care on child and parent health and well-being, healthcare quality and health service use up to 2 years postimplementation. A population-level evaluation will use routinely collected pseudonymised healthcare data to conduct a service-use analysis for all CYP registered with a participating general practice (n=~90 000) with the rate of non-elective admissions as the primary outcome. We will seek consent from a subset of this population, with specific conditions (target n=2138) to assess the impact on patient-reported outcomes using the Paediatric Quality of Life Inventory (PedsQL) and Warwick-Edinburgh Mental Well-Being Scale (WEBWMS) as, respectively, the child- and parent-related primary outcomes.
ETHICS AND DISSEMINATION


Ethics approval obtained from South West-Cornwall & Plymouth Research Ethics Committee. Results will be submitted for publication in peer-reviewed journals. Findings will be generalisable to community-based models of care, especially in urban settings. Our process evaluation will identify barriers and enablers of implementation and delivery of care salient to the context and condition.
TRIAL REGISTRATION NUMBER


NCT03461848; Pre-results.",2019,"Seventy general practices across two London boroughs, grouped into 23 clusters, were randomised to provide either the CYPHP model of care (n=11) or enhanced usual care (n=12).The evaluation will measure the impact of the CYPHP Evelina London model of care on child and parent health and well-being, healthcare quality and health service use up to 2 years postimplementation.","[""Children and Young People's Health Partnership (CYPHP) Evelina London model of care"", 'Seventy general practices across two London boroughs, grouped into 23 clusters', ""Children and Young People's Health Partnership (CYPHP""]","['CYPHP model of care (n=11) or enhanced usual care (n=12).The evaluation will measure the impact of the CYPHP Evelina London model of care on child and parent health and well-being, healthcare quality and health service use up to 2\u2009years postimplementation']",['Paediatric Quality of Life Inventory (PedsQL) and Warwick-Edinburgh Mental Well-Being Scale (WEBWMS'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4273514', 'cui_str': 'Warwick Edinburgh Mental Well Being Scale'}]",70.0,0.0944767,"Seventy general practices across two London boroughs, grouped into 23 clusters, were randomised to provide either the CYPHP model of care (n=11) or enhanced usual care (n=12).The evaluation will measure the impact of the CYPHP Evelina London model of care on child and parent health and well-being, healthcare quality and health service use up to 2 years postimplementation.","[{'ForeName': 'James Joseph', 'Initials': 'JJ', 'LastName': 'Newham', 'Affiliation': ""Department of Women & Children's Health, King's College London, London, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Forman', 'Affiliation': ""Department of Women & Children's Health, King's College London, London, UK.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Heys', 'Affiliation': 'Institute for Global Health, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lemer', 'Affiliation': ""Guy's Hospital, London, UK.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elsherbiny', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Satherley', 'Affiliation': ""Department of Women & Children's Health, King's College London, London, UK.""}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Lingam', 'Affiliation': ""School of Women's & Children's Health, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Wolfe', 'Affiliation': ""Department of Women & Children's Health, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2018-027301']
496,32070323,Investigating the effect of vitamin D vaginal suppository on sexual function among postmenopausal women: study protocol for a randomized controlled trial.,"BACKGROUND


Menopause is associated with changes in sexual function which are partly due to vaginal atrophy in response to estrogen reduction. Estrogen administration temporarily reduces the symptoms of vaginal dryness, but long-term exposure to this drug is likely to be associated with serious complications. Considering the promising results of previous studies concerning the effect of vitamin D on vaginal dryness, the proposed study will investigate the effect of vitamin D vaginal suppository on the sexual function of postmenopausal women.
METHODS


In a randomized, controlled clinical trial, 105 postmenopausal women will be randomly assigned to three groups receiving vitamin D vaginal suppository, placebo vaginal suppository, or control (no intervention). Vitamin D vaginal suppositories contain 1000 units of vitamin D3. The timing of the use of vitamin D vaginal suppositories and placebo suppositories will be every night in the first 2 weeks, and every other night in the following 6 weeks (8 weeks in total). The primary outcome will be the sexual function of participants which will be assessed using the Female Sexual Function Index (FSFI) before and immediately after the intervention, and at 1 and 2 months after the end of the intervention. The side effects of these suppositories will be examined as a secondary consequence of the study. Data will be analyzed using SPSS software version 25. In the case of normal distribution of data, the mean score of sexual function will be compared between the groups using a repeated measurements ANOVA. If statistical analysis leads to significant results, the post-hoc test will be used to determine the differences between the groups. Comparison of demographic and fertility characteristics of the women will be carried out using statistical tests such as chi-squares and t-tests. A significance level of p < .05 will be used for statistical analyses.
DISCUSSION


If vitamin D vaginal suppositories improve sexual function among premenopausal women with long-term effects and minimum side effects, the suppositories will be considered a safe complementary and alternative choice for alleviating sexual dysfunction among this group.
TRIAL REGISTRATION


IRCT20180704040346N1 at 2018-10-13 prospectively registered.",2020,"If vitamin D vaginal suppositories improve sexual function among premenopausal women with long-term effects and minimum side effects, the suppositories will be considered a safe complementary and alternative choice for alleviating sexual dysfunction among this group.
","['postmenopausal women', 'IRCT20180704040346N1 at 2018-10-13 prospectively registered', 'premenopausal women', '105 postmenopausal women']","['Estrogen', 'vitamin D vaginal suppositories and placebo suppositories', 'Vitamin D vaginal suppositories', 'vitamin D vaginal suppository', 'vitamin D vaginal suppositories', 'vitamin D', 'vitamin D vaginal suppository, placebo vaginal suppository, or control (no intervention', 'vitamin D3']","['symptoms of vaginal dryness', 'mean score of sexual function', 'sexual function', 'sexual function of participants which will be assessed using the Female Sexual Function Index (FSFI']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1136199', 'cui_str': 'Vaginal Suppository'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",105.0,0.159934,"If vitamin D vaginal suppositories improve sexual function among premenopausal women with long-term effects and minimum side effects, the suppositories will be considered a safe complementary and alternative choice for alleviating sexual dysfunction among this group.
","[{'ForeName': 'Zinat', 'Initials': 'Z', 'LastName': 'Sarebani', 'Affiliation': 'Students research committee, School of Nursing & Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoradi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Bahonar blv., Qazvin, 34197-59811, Iran. z.alimoradi@qums.ac.ir.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Aali', 'Affiliation': 'Pharmacology Department, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Monirsadat', 'Initials': 'M', 'LastName': 'Mirzadeh', 'Affiliation': 'Community Medicine Department, Metabolic Diseases Research Center, Research Institute For Prevention Of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Chegini', 'Affiliation': 'Obstetrics and Gynecology Department, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Abbaspour', 'Affiliation': 'Targeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'Psychology Department, Nottingham Trent University, Nottingham, UK.'}]",BMC women's health,['10.1186/s12905-020-00899-6']
497,32075406,"Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1).","OBJECTIVE


To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of episodic migraine.
METHODS


The PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-1 (PROMISE-1) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with episodic migraine were randomized to eptinezumab 30 mg, 100 mg, 300 mg, or placebo for up to four intravenous (IV) doses administered every 12 weeks. The primary endpoint was change from baseline in monthly migraine days (MMDs) over weeks 1-12.
RESULTS


A total of 888 patients received treatment across 84 study sites. Mean MMDs at baseline was ∼8.6 across treatment groups. Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1-12 compared with placebo (30 mg, -4.0; 100 mg, -3.9,  p  = 0.0182; 300 mg, -4.3; placebo, -3.2,  p  = 0.0001). Treatment-emergent adverse events were reported by 58.4% (30 mg), 63.2% (100 mg), 57.6% (300 mg), and 59.5% (placebo) of patients. Treatment-emergent adverse events reported by ≥2% of eptinezumab-treated patients at an incidence greater than placebo included: upper respiratory tract infection (30 mg, 11.4%; 100 mg, 9.9%; 300 mg, 10.3%; placebo, 7.2%), and fatigue (30 mg, 2.3%; 100 mg, 3.6%; 300 mg, 3.6%; placebo, <1%).
CONCLUSION


Eptinezumab (100 mg or 300 mg) significantly reduced migraine frequency, was well tolerated, and had an acceptable safety profile when used for the preventive treatment of migraine in adults with episodic migraine.  ClinicalTrials.gov identifier:  NCT02559895.",2020,"Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1-12 compared with placebo (30 mg, -4.0; 100 mg, -3.9,  p  = 0.0182; 300 mg, -4.3; placebo, -3.2,  p  = 0.0001).","['Adults with episodic migraine', 'episodic migraine', 'adults with episodic migraine', '888 patients received treatment across 84 study sites']","['placebo', 'Eptinezumab', 'eptinezumab', 'eptinezumab 30\u2009mg, 100\u2009mg, 300\u2009mg, or placebo']","['Mean MMDs', ' upper respiratory tract infection', 'migraine frequency', 'change from baseline in monthly migraine days (MMDs', 'reducing MMDs', 'fatigue']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",888.0,0.469107,"Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1-12 compared with placebo (30 mg, -4.0; 100 mg, -3.9,  p  = 0.0182; 300 mg, -4.3; placebo, -3.2,  p  = 0.0001).","[{'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Saper', 'Affiliation': 'Michigan Headache & Neurological Institute, Ann Arbor, MI, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Schaeffler', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Biondi', 'Affiliation': 'Alder BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pederson', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Allan', 'Affiliation': 'Alder BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420905132']
498,31465088,Effect of Aflibercept Plus Modified FOLFOX6 Induction Chemotherapy Before Standard Chemoradiotherapy and Surgery in Patients With High-Risk Rectal Adenocarcinoma: The GEMCAD 1402 Randomized Clinical Trial.,"Importance


Preclinical studies suggest that a vascular endothelial growth factor (VEGF) blockade may play a role in the preoperative treatment of rectal adenocarcinoma; however, how to combine anti-VEGF drugs with neoadjuvant chemotherapy (CT) and/or chemoradiotherapy (CRT) remains controversial.
Objective


To study the effect of aflibercept plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) induction CT prior to standard CRT and total mesorectal excision (TME) surgery in patients with high-risk rectal adenocarcinoma.
Design, Setting, and Participants


In the Grupo Español Multidisciplinar En Cancer Digestivo (GEMCAD) 1402 phase 2 randomized clinical trial, 180 patients aged 18 to 75 years, identified by centrally reviewed magnetic resonance imaging to have mrT3c-d/T4/N2 rectal adenocarcinoma, were enrolled from 20 treatment centers in Spain between January 2015 and March 2017. Patients were randomized in a 2:1 treatment to control arm ratio. The primary end point was evaluated at 2 interim and 1 final analyses. The study was designed to perform hypothesis testing at α = .2 and β = .2. A 2-sided P value of <.1984 in the final analysis of the intention-to-treat population was the threshold for considering the experimental treatment to be more effective than the control.
Interventions


Patients received neoadjuvant mFOLFOX6 with (arm A; n = 115) or without (arm B; n = 65) aflibercept, 4 mg/kg (every 2 weeks, 6 cycles, and 3 months) prior to standard CRT and TME surgery.
Main Outcomes and Measures


The primary end point was a pathologic complete response (pCR) (ypT0N0). Secondary end points included toxic effects, surgical morbidity, R0 resections, compliance, and 3-year disease-free survival.
Results


For the 115 patients who received treatment with mFOLFOX6 plus aflibercept, the median (range) age was 60 (32-75) years, 77 men (66.9%) and 38 women (33.0%). For the 65 patients who received induction CT treatment with only mFOLFOX6, the median (range) age was 65 (39-75) years, 39 men (60.0%) and 26 women (40.0%). The pCR rate in the intention-to-treat population was 22.6% (95% CI, 15.3%-31.3%) in arm A and 13.8% (95% CI, 6.5%-24.6%) in arm B (P = .15). The main differential toxic effect was grade 3/4 hypertension during the induction phase. Postoperative complications were similar in both arms (15.5% in arm A and 12.9% in arm B). A total of 106 patients (92.1%) in arm A and 63 (96.9%) in arm B received all treatment cycles.
Conclusions and Relevance


The study met its primary end point. The findings suggest that adding aflibercept to an induction regimen using mFOLFOX6 plays a role in increasing the pCR rate in patients with high-risk rectal adenocarcinoma, without substantially increasing surgical complications. The GEMCAD 1402 trial provides a rationale for phase 3 trials.
Trial Registration


ClinicalTrials.gov identifier: NCT02340949.",2019,Postoperative complications were similar in both arms (15.5% in arm A and 12.9% in arm B).,"['patients with high-risk rectal adenocarcinoma', 'Patients With High-Risk Rectal Adenocarcinoma', '180 patients aged 18 to 75 years, identified by centrally reviewed magnetic resonance imaging to have mrT3c-d/T4/N2 rectal adenocarcinoma, were enrolled from 20 treatment centers in Spain between January 2015 and March 2017', '65 patients who received induction CT treatment with only mFOLFOX6, the median (range) age was 65 (39-75) years, 39 men (60.0%) and 26 women (40.0', '115 patients who received treatment with mFOLFOX6 plus aflibercept, the median (range) age was 60 (32-75) years, 77 men (66.9%) and 38 women (33.0']","['Induction Chemotherapy', 'neoadjuvant chemotherapy (CT) and/or chemoradiotherapy (CRT', 'Grupo Español Multidisciplinar', 'neoadjuvant mFOLFOX6 with (arm A; n\u2009=\u2009115) or without (arm B; n\u2009=\u200965) aflibercept', 'aflibercept plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) induction CT prior to standard CRT and total mesorectal excision (TME) surgery', 'Chemoradiotherapy and Surgery', 'En Cancer Digestivo (GEMCAD', 'Aflibercept Plus Modified FOLFOX6']","['pCR rate', 'toxic effects, surgical morbidity, R0 resections, compliance, and 3-year disease-free survival', 'pathologic complete response (pCR) (ypT0N0', 'Postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum (disorder)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",180.0,0.156264,Postoperative complications were similar in both arms (15.5% in arm A and 12.9% in arm B).,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández-Martos', 'Affiliation': 'Fundación Instituto Valenciano de Oncología, Valencia, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Pericay', 'Affiliation': 'Hospital de Sabadell Corporació Sanitària Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Losa', 'Affiliation': 'Hospital Sant Joan Despí Moisès Broggi, Barcelona, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'García-Carbonero', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Layos', 'Affiliation': 'B-ARGO Group Catalan, Institute of Oncology (ICO), Badalona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Rodríguez-Salas', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Martin-Richard', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Alonso-Orduña', 'Affiliation': 'Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Vera', 'Affiliation': 'Hospital de Navarra, Pamplona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gallego', 'Affiliation': 'Hospital General Universitario de Elche, Alicante, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': ""Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Antonieta', 'Initials': 'A', 'LastName': 'Salud', 'Affiliation': 'Hospital Universitario Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Nogué', 'Affiliation': 'Hospital General de Granollers, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Maurel', 'Affiliation': 'Hospital Clinic of Barcelona, Translational Genomics and Targeted Therapeutics in Solid Tumors Group, IDIBAPS, University of Barcelona, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Guash', 'Affiliation': 'Fundació Althaia de Manresa, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Montagut', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lopez', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Macias', 'Affiliation': 'Hospital de Sabadell Corporació Sanitària Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Rakesh K', 'Initials': 'RK', 'LastName': 'Jain', 'Affiliation': 'Edwin Steele Laboratories for Tumor Biology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Xabier', 'Initials': 'X', 'LastName': 'Garcia-Albeniz', 'Affiliation': 'RTI Health Solutions, Barcelona, Spain.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2294']
499,31375609,A Study Investigating Markers in PLeural Effusion (SIMPLE): a prospective and double-blind diagnostic study.,"INTRODUCTION


Serum and fluid laboratory markers are valuable for exploring the aetiologies of pleural effusion (PE) because of their relative non-invasiveness, low cost, objective result and short turnaround time. The diagnostic accuracy of these potential markers needs to be rigorously evaluated before their widespread application in clinical practice. Here, we plan to perform a Study Investigating Markers in PLeural Effusion (SIMPLE).
METHODS AND ANALYSIS


This is a prospective and double-blind clinical trial which is being performed at the Affiliated Hospital of Inner Mongolia Medical University, China. Adult patients admitted for the evaluation of aetiology of PE from September 2018 to July 2021 will be enrolled after informed consent. Pleural fluid and serum specimens will be collected and stored at -80°C for the laboratory analysis. The final diagnosis will be concurred with further imaging, microbiology, cytology and biopsy if needed. The results of investigated laboratory markers will be unknown to the clinicians who will make diagnosis and the clinical diagnoses will be unknown to the laboratory technicians who will determine markers. The diagnostic accuracy of investigated markers will be assessed using receiver operating characteristics (ROC) curve analysis, multivariable logistic regression model, decision curve analysis (DCA), net reclassification index (NRI) and integrated discriminatory index (IDI).
ETHICS AND DISSEMINATION


The study is approved by the Ethic Committee of the Affiliated Hospital of Inner Mongolia Medical University (NO: 2018011). The results of SIMPLE will be submitted to international scientific peer-reviewed journals or conferences in laboratory medicine or respiratory medicine, thoracic diseases.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1800017449); Pre-results.",2019,"The results of SIMPLE will be submitted to international scientific peer-reviewed journals or conferences in laboratory medicine or respiratory medicine, thoracic diseases.
","['Affiliated Hospital of Inner Mongolia Medical University, China', 'Adult patients admitted for the evaluation of aetiology of PE from September 2018 to July 2021 will be enrolled after informed consent', 'Ethic Committee of the Affiliated Hospital of Inner Mongolia Medical University']",[],"['decision curve analysis (DCA), net reclassification index (NRI) and integrated discriminatory index (IDI']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1314792', 'cui_str': 'Causality'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}]",[],"[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.131485,"The results of SIMPLE will be submitted to international scientific peer-reviewed journals or conferences in laboratory medicine or respiratory medicine, thoracic diseases.
","[{'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Han', 'Affiliation': 'Department of Laboratory Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Laboratory Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Laboratory Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Pei-Heng', 'Initials': 'PH', 'LastName': 'Ouyang', 'Affiliation': 'Department of Laboratory Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Hu', 'Affiliation': 'Department of Laboratory Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}]",BMJ open,['10.1136/bmjopen-2018-027287']
500,31839281,Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial.,"BACKGROUND


Two large clinical trials have shown a reduced rate of breast cancer development in high-risk women in the initial 5 years of follow-up after use of aromatase inhibitors (MAP.3 and International Breast Cancer Intervention Study II [IBIS-II]). Here, we report blinded long-term follow-up results for the IBIS-II trial, which compared anastrozole with placebo, with the objective of determining the efficacy of anastrozole for preventing breast cancer (both invasive and ductal carcinoma in situ) in the post-treatment period.
METHODS


IBIS-II is an international, randomised, double-blind, placebo-controlled trial. Postmenopausal women at increased risk of developing breast cancer were recruited and were randomly assigned (1:1) to either anastrozole (1 mg per day, oral) or matching placebo daily for 5 years. After treatment completion, women were followed on a yearly basis to collect data on breast cancer incidence, death, other cancers, and major adverse events (cardiovascular events and fractures). The primary outcome was all breast cancer.
FINDINGS


3864 women were recruited between Feb 2, 2003, and Jan 31, 2012. 1920 women were randomly assigned to 5 years anastrozole and 1944 to placebo. After a median follow-up of 131 months (IQR 105-156), a 49% reduction in breast cancer was observed for anastrozole (85 vs 165 cases, hazard ratio [HR] 0·51, 95% CI 0·39-0·66, p<0·0001). The reduction was larger in the first 5 years (35 vs 89, 0·39, 0·27-0·58, p<0·0001), but still significant after 5 years (50 vs 76 new cases, 0·64, 0·45-0·91, p=0·014), and not significantly different from the first 5 years (p=0·087). Invasive oestrogen receptor-positive breast cancer was reduced by 54% (HR 0·46, 95% CI 0·33-0·65, p<0·0001), with a continued significant effect in the period after treatment. A 59% reduction in ductal carcinoma in situ was observed (0·41, 0·22-0·79, p=0·0081), especially in participants known to be oestrogen receptor-positive (0·22, 0·78-0·65, p<0·0001). No significant difference in deaths was observed overall (69 vs 70, HR 0·96, 95% CI 0·69-1·34, p=0·82) or for breast cancer (two anastrozole vs three placebo). A significant decrease in non-breast cancers was observed for anastrozole (147 vs 200, odds ratio 0·72, 95% CI 0·57-0·91, p=0·0042), owing primarily to non-melanoma skin cancer. No excess of fractures or cardiovascular disease was observed.
INTERPRETATION


This analysis has identified a significant continuing reduction in breast cancer with anastrozole in the post-treatment follow-up period, with no evidence of new late side-effects. Further follow-up is needed to assess the effect on breast cancer mortality.
FUNDING


Cancer Research UK, the National Health and Medical Research Council Australia, Breast Cancer Research Foundation, Sanofi Aventis, and AstraZeneca.",2020,"A 59% reduction in ductal carcinoma in situ was observed (0·41, 0·22-0·79, p=0·0081), especially in participants known to be oestrogen receptor-positive (0·22, 0·78-0·65, p<0·0001).","['breast cancer prevention (IBIS-II', '3864 women were recruited between Feb 2, 2003, and Jan 31, 2012', '1920 women', 'breast cancer (both invasive and ductal carcinoma in situ', 'Postmenopausal women at increased risk of developing breast cancer']","['matching placebo', 'anastrozole with placebo', 'placebo', 'anastrozole']","['Invasive oestrogen receptor-positive breast cancer', 'hazard ratio', 'ductal carcinoma', 'fractures or cardiovascular disease', 'breast cancer', 'deaths', 'breast cancer incidence, death, other cancers, and major adverse events (cardiovascular events and fractures', 'non-breast cancers']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0325469', 'cui_str': 'Ibis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1920.0,0.367668,"A 59% reduction in ductal carcinoma in situ was observed (0·41, 0·22-0·79, p=0·0081), especially in participants known to be oestrogen receptor-positive (0·22, 0·78-0·65, p<0·0001).","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University London, London, UK. Electronic address: j.cuzick@qmul.ac.uk.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sestak', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University London, London, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Forbes', 'Affiliation': 'Australia New Zealand Breast Cancer Trials Group Newcastle, University of Newcastle, Calvary Mater Hospital, Waratah, NSW, Australia.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, Royal Marsden, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cawthorn', 'Affiliation': 'Breast Care Centre, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mansel', 'Affiliation': 'University Department of Surgery, University of Wales College of Medicine, Cardiff, UK.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Frankfurt, Germany.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': 'Division of Chemoprevention and Genetics, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'D Gareth', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': 'Prevent Breast Cancer Unit, Nightingale Breast Screening Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Prevent Breast Cancer Unit, Nightingale Breast Screening Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32955-1']
501,31586510,Sugar-Sweetened Beverage Health Warnings and Purchases: A Randomized Controlled Trial.,"INTRODUCTION


Five U.S. states have proposed policies to require health warnings on sugar-sweetened beverages, but warnings' effects on actual purchase behavior remain uncertain. This study evaluated the impact of sugar-sweetened beverage health warnings on sugar-sweetened beverage purchases.
STUDY DESIGN


Participants completed one study visit to a life-sized replica of a convenience store in North Carolina. Participants chose six items (two beverages, two foods, and two household products). One item was randomly selected for them to purchase and take home. Participants also completed a questionnaire. Researchers collected data in 2018 and conducted analyses in 2019.
SETTING/PARTICIPANTS


Participants were a demographically diverse convenience sample of 400 adult sugar-sweetened beverage consumers (usual consumption ≥12 ounces/week).
INTERVENTION


Research staff randomly assigned participants to a health warning arm (sugar-sweetened beverages in the store displayed a front-of-package health warning) or a control arm (sugar-sweetened beverages displayed a control label).
MAIN OUTCOME MEASURES


The primary trial outcome was sugar-sweetened beverage calories purchased. Secondary outcomes included reactions to trial labels (e.g., negative emotions) and sugar-sweetened beverage perceptions and attitudes (e.g., healthfulness).
RESULTS


All 400 participants completed the trial and were included in analyses. Health warning arm participants were less likely to be Hispanic and to have overweight/obesity than control arm participants. In intent-to-treat analyses adjusting for Hispanic ethnicity and overweight/obesity, health warnings led to lower sugar-sweetened beverage purchases (adjusted difference, -31.4 calories; 95% CI= -57.9, -5.0). Unadjusted analyses yielded similar results (difference, -32.9 calories; 95% CI= -58.9, -7.0). Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions. Trial arms did not differ on perceptions of sugar-sweetened beverages' added sugar content, healthfulness, appeal/coolness, or disease risk.
CONCLUSIONS


Brief exposure to health warnings reduced sugar-sweetened beverage purchases in this naturalistic RCT. Sugar-sweetened beverage health warning policies could discourage sugar-sweetened beverage consumption.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03511937.",2019,"Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions.","['All 400 participants completed the trial and were included in analyses', '2018 and conducted analyses in 2019', 'Participants completed one study visit to a life-sized replica of a convenience store in North Carolina', 'Participants were a demographically diverse convenience sample of 400 adult sugar-sweetened beverage consumers (usual consumption ≥12 ounces/week']","['Sugar-Sweetened Beverage Health Warnings and Purchases', 'health warning arm (sugar-sweetened beverages in the store displayed a front-of-package health warning) or a control arm (sugar-sweetened beverages displayed a control label']","[""perceptions of sugar-sweetened beverages' added sugar content, healthfulness, appeal/coolness, or disease risk"", 'sugar-sweetened beverage calories purchased', 'reactions to trial labels (e.g., negative emotions) and sugar-sweetened beverage perceptions and attitudes (e.g., healthfulness']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0556977', 'cui_str': 'oz/week'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",400.0,0.148836,"Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions.","[{'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina. Electronic address: agrummon@unc.edu.'}, {'ForeName': 'Lindsey S', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Shelley D', 'Initials': 'SD', 'LastName': 'Golden', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ranney', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.06.019']
502,30707661,Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma.,"PURPOSE


The aim of this open-label, first-in-setting, randomized phase III trial was to evaluate the efficacy of alisertib, an investigational Aurora A kinase inhibitor, in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).
PATIENTS AND METHODS


Adult patients with relapsed/refractory PTCL-one or more prior therapy-were randomly assigned 1:1 to receive oral alisertib 50 mg two times per day (days 1 to 7; 21-day cycle) or investigator-selected single-agent comparator, including intravenous pralatrexate 30 mg/m 2  (once per week for 6 weeks; 7-week cycle), or intravenous gemcitabine 1,000 mg/m 2  or intravenous romidepsin 14 mg/m 2  (days 1, 8, and 15; 28-day cycle). Tumor tissue (disease subtype) and imaging were assessed by independent central review. Primary outcomes were overall response rate and progression-free survival (PFS). Two interim analyses and one final analysis were planned.
RESULTS


Between May 2012 and October 2014, 271 patients were randomly assigned (alisertib, n = 138; comparator, n = 133). Enrollment was stopped early on the recommendation of the independent data monitoring committee as a result of the low probability of alisertib achieving PFS superiority with full enrollment. Centrally assessed overall response rate was 33% for alisertib and 45% for the comparator arm (odds ratio, 0.60; 95% CI, 0.33 to 1.08). Median PFS was 115 days for alisertib and 104 days for the comparator arm (hazard ratio, 0.87; 95% CI, 0.637 to 1.178). The most common adverse events were anemia (53% of alisertib-treated patients v 34% of comparator-treated patients) and neutropenia (47% v 31%, respectively). A lower percentage of patients who received alisertib (9%) compared with the comparator (14%) experienced events that led to study drug discontinuation. Of 26 on-study deaths, five were considered treatment related (alisertib, n = 3 of 11; comparator, n = 2 of 15). Two-year overall survival was 35% for each arm.
CONCLUSION


In patients with relapsed/refractory PTCL, alisertib was not statistically significantly superior to the comparator arm.",2019,"Median PFS was 115 days for alisertib and 104 days for the comparator arm (hazard ratio, 0.87; 95% CI, 0.637 to 1.178).","['patients with relapsed/refractory peripheral T-cell lymphoma (PTCL', 'Between May 2012 and October 2014, 271 patients were randomly assigned (alisertib, n = 138; comparator, n = 133', 'Adult patients with relapsed/refractory PTCL-one or more prior therapy', 'Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma']","['oral alisertib 50 mg two times per day (days 1 to 7; 21-day cycle) or investigator-selected single-agent comparator, including intravenous pralatrexate 30 mg/m 2', 'gemcitabine 1,000 mg/m 2  or intravenous romidepsin 14']","['overall response rate and progression-free survival (PFS', 'neutropenia', 'overall response rate', 'overall survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0079774', 'cui_str': 'Peripheral T-Cell Lymphoma'}, {'cui': 'C1175474', 'cui_str': 'PtCl(2)(OH)(2)(dimethylamine) (isopropylamine)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2987636'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2987636'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1721300', 'cui_str': 'Pralatrexate'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527027', 'cui_str': 'romidepsin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",271.0,0.174467,"Median PFS was 115 days for alisertib and 104 days for the comparator arm (hazard ratio, 0.87; 95% CI, 0.637 to 1.178).","[{'ForeName': 'Owen A', 'Initials': 'OA', 'LastName': ""O'Connor"", 'Affiliation': '1 Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': '2 Ankara University Medical School, Ankara, Turkey.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Jacobsen', 'Affiliation': '3 Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Roncero', 'Affiliation': ""4 Institut Català d'Oncologia de Girona, Girona, Spain.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Trotman', 'Affiliation': '5 Concord Repatriation General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Demeter', 'Affiliation': '7 Semmelweis Egyetem Általános Orvostudományi Kar, Budapest, Hungary.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': '8 St. István and St. László Hospital, Budapest, Hungary.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Pereira', 'Affiliation': '10 Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': '11 Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Beaven', 'Affiliation': '12 Duke University Health System, Durham, NC.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Caballero', 'Affiliation': '13 Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Horwitz', 'Affiliation': '14 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lennard', 'Affiliation': '15 Northern Centre for Cancer Care, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Turgut', 'Affiliation': '16 Ondokuz Mayis University, Samsun, Turkey.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Hamerschlak', 'Affiliation': '17 Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Francesco A', 'Initials': 'FA', 'LastName': ""d'Amore"", 'Affiliation': '18 Aarhus Universitetshospital, Aarhus, Denmark.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Foss', 'Affiliation': '19 Smilow Cancer Hospital at Yale New Haven, New Haven, CT.'}, {'ForeName': 'Won-Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': '20 Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': '21 Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': '22 University of Bologna, Bologna, Italy.'}, {'ForeName': 'Carlos S', 'Initials': 'CS', 'LastName': 'Chiattone', 'Affiliation': '23 Santa Casa Medical School, São Paulo, Brazil.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': '24 Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Trümper', 'Affiliation': '25 University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': '26 Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sheldon-Waniga', 'Affiliation': '26 Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Claudio Dansky', 'Initials': 'CD', 'LastName': 'Ullmann', 'Affiliation': '26 Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': '26 Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'E Jane', 'Initials': 'EJ', 'LastName': 'Leonard', 'Affiliation': '26 Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Andrei R', 'Initials': 'AR', 'LastName': 'Shustov', 'Affiliation': '27 University of Washington, Seattle Cancer Care Alliance, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00899']
503,31477161,"Baseline urate level and renal function predict outcomes of urate-lowering therapy using low doses of febuxostat and benzbromarone: a prospective, randomized controlled study in a Chinese primary gout cohort.","BACKGROUND


Low doses of febuxostat or benzbromarone are widely used in Asian countries, but lacking studies to compare the efficacy and safety of the two urate-lowering drugs.
METHODS


To compare the efficacy and safety of low-dose febuxostat with low-dose benzbromarone in patients with primary gout, a randomized controlled, open-label trial was performed among male patients with primary gout for urate-lowering therapy (ULT) in a dedicated gout clinic in China. Randomization was carried out by a third-party institution according to random number table. Patients were randomly assigned 1:1 to febuxostat group (Feb group) (20 mg daily) or benzbromarone group (Ben group) (25 mg daily) and treated for 12 weeks. General information and biochemical data were collected at baseline and at every visit monthly. Clinical characteristics before and after the ULT were analyzed in the two groups by SPSS and EmpowerStats software.
RESULTS


Two hundred forty patients were enrolled and randomized in the two groups, with 214 patients completing 12 weeks' ULT (105 in the Feb group and 109 in the Ben group). After 12 weeks, substantial percentages of patients in both Feb and Ben group achieved the target serum uric acid (sUA) (< 360 μmol/L) and serum urate levels were reduced significantly for both groups (Feb 39.5% and 156.83 μmol/L vs. Ben 35.7% and 163.99 μmol/L). Multivariate analysis suggests baseline sUA level and renal function were associated with the outcome of the rate of achieving target sUA (RAT). Sub-group analysis suggests low doses of febuxostat and benzbromarone rendered better RAT for patients with sUA < 540 μmol/L and creatinine clearance rate (Ccr) ≤ 110 mL min -1  1.73 m -2  at baseline. The drugs were well tolerated, and the incidence of gout flares in Feb group was similar with that in Ben group (22.85% vs. 33.94%).
CONCLUSION


Overall, febuxostat 20 mg daily and benzbromarone 25 mg daily reduced sUA, and gout patients with sUA level < 540 μmol/L or Ccr ≤ 110 mL min -1  1.73 m -2  at baseline had better chance to achieve target uric acid levels. The current study suggests sUA level and renal function are key factors to consider when recommending low doses of febuxostat and benzbromarone to gout patients.
TRIAL REGISTRATION


Registered with ChiCTR, No. ChiCTR1800019352 (retrospectively registered).",2019,"The drugs were well tolerated, and the incidence of gout flares in Feb group was similar with that in Ben group (22.85% vs. 33.94%).
","['Chinese primary gout cohort', 'male patients with primary gout for urate-lowering therapy (ULT) in a dedicated gout clinic in China', 'patients with primary gout', ""Two hundred forty patients were enrolled and randomized in the two groups, with 214 patients completing 12\u2009weeks' ULT (105 in the Feb group and 109 in the Ben group""]","['febuxostat and benzbromarone', 'febuxostat group (Feb group) (20\u2009mg daily) or benzbromarone', 'benzbromarone', 'urate-lowering therapy', 'febuxostat', 'febuxostat or benzbromarone', 'low-dose febuxostat with low-dose benzbromarone']","['target serum uric acid (sUA', 'serum urate levels', 'rate of achieving target sUA (RAT', 'baseline sUA level and renal function', 'incidence of gout flares', 'target uric acid levels', 'efficacy and safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0149896', 'cui_str': 'Primary gout (disorder)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0303400', 'cui_str': 'Indium-109 (substance)'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0005035', 'cui_str': 'Benzbromarone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",240.0,0.142492,"The drugs were well tolerated, and the incidence of gout flares in Feb group was similar with that in Ben group (22.85% vs. 33.94%).
","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Liang', 'Affiliation': 'The Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Mingshu', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ruixia', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'The Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Geratology, the 971th Hospital of PLA, Qingdao, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'The Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'The Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'The Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China.'}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China.'}, {'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Aichang', 'Initials': 'A', 'LastName': 'Ji', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xinjiang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China. sydwu@foxmail.com.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'The Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Qingdao, China. changguili@vip.163.com.'}]",Arthritis research & therapy,['10.1186/s13075-019-1976-x']
504,31303190,Effects of a multipronged beverage intervention on young children's beverage intake and weight: a cluster-randomized pilot study.,"OBJECTIVE


To evaluate whether a multipronged pilot intervention promoting healthier beverage consumption improved at-home beverage consumption and weight status among young children.
DESIGN


In this exploratory pilot study, we randomly assigned four childcare centres to a control (delayed-intervention) condition or a 12-week intervention that promoted consumption of healthier beverages (water, unsweetened low- or non-fat milk) and discouraged consumption of less-healthy beverages (juice, sugar-sweetened beverages, high-fat or sweetened milk). The multipronged intervention was delivered via childcare centres; simultaneously targeted children, parents and childcare staff; and included environmental changes, policies and education. Outcomes were measured at baseline and immediately post-intervention and included children's (n 154) at-home beverage consumption (assessed via parental report) and overweight/obese status (assessed via objectively measured height and weight). We estimated intervention impact using difference-in-differences models controlling for children's demographics and classroom.
SETTING


Two northern California cities, USA, 2013-2014.
PARTICIPANTS


Children aged 2-5 years and their parents.
RESULTS


Relative to control group children, intervention group children reduced their consumption of less-healthy beverages from baseline to follow-up by 5·9 ounces/d (95 % CI -11·2, -0·6) (-174·5 ml/d; 95 % CI -331·2, -17·7) and increased their consumption of healthier beverages by 3·5 ounces/d (95 % CI -2·6, 9·5) (103·5 ml/d; 95 % CI -76·9, 280·9). Children's likelihood of being overweight decreased by 3 percentage points (pp) in the intervention group and increased by 3 pp in the control group (difference-in-differences: -6 pp; 95 % CI -15, 3).
CONCLUSIONS


Our exploratory pilot study suggests that interventions focused comprehensively on encouraging healthier beverage consumption could improve children's beverage intake and weight. Findings should be confirmed in longer, larger studies.",2019,"Children's likelihood of being overweight decreased by 3 percentage points (pp) in the intervention group and increased by 3 pp in the control group (difference-in-differences: -6 pp; 95 % CI -15, 3).
","[""young children's beverage intake and weight"", 'young children', ""children's demographics and classroom"", 'Two northern California cities, USA, 2013-2014', 'Children aged 2-5 years and their parents']","['multipronged intervention was delivered via childcare centres; simultaneously targeted children, parents and childcare staff; and included environmental changes, policies and education', 'multipronged beverage intervention', 'multipronged pilot intervention promoting healthier beverage consumption', 'control (delayed-intervention) condition or a 12-week intervention that promoted consumption of healthier beverages (water, unsweetened low- or non-fat milk) and discouraged consumption of less-healthy beverages (juice, sugar-sweetened beverages, high-fat or sweetened milk']","['consumption of healthier beverages', ""Children's likelihood of being overweight"", 'consumption of less-healthy beverages']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]",,0.198502,"Children's likelihood of being overweight decreased by 3 percentage points (pp) in the intervention group and increased by 3 pp in the control group (difference-in-differences: -6 pp; 95 % CI -15, 3).
","[{'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Amelie A', 'Initials': 'AA', 'LastName': 'Hecht', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Alkon', 'Affiliation': 'School of Nursing, Department of Family Health Care Nursing, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Claire D', 'Initials': 'CD', 'LastName': 'Brindis', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anisha I', 'Initials': 'AI', 'LastName': 'Patel', 'Affiliation': 'Department of Pediatrics, Stanford University, 1265 Welch Road MSOB X240, Mailcode 5459, Stanford, CA 94305, USA.'}]",Public health nutrition,['10.1017/S1368980019001629']
505,31646767,Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass.,"Methylprednisolone is used in neonates to modulate cardiopulmonary bypass (CPB)-induced inflammation, but optimal dosing and exposure are unknown. We used plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations from neonates enrolled in a randomized trial comparing one vs. two doses of methylprednisolone to develop indirect response population pharmacokinetic/pharmacodynamic models characterizing the exposure-response relationships. We applied the models to simulate methylprednisolone dosages resulting in the desired IL-6 and -10 exposures, known mediators of CPB-induced inflammation. A total of 64 neonates (median weight 3.2 kg, range 2.2-4.3) contributed 290 plasma methylprednisolone concentrations (range 1.07-12,700 ng/mL) and IL-6 (0-681 pg/mL) and IL-10 (0.1-1125 pg/mL). Methylprednisolone plasma exposure following a single 10 mg/kg intravenous dose inhibited IL-6 and stimulated IL-10 production when compared with placebo. Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit. Clinical efficacy studies are needed to evaluate the effect of optimized dosing on outcomes.",2019,Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit.,"['Neonates Undergoing Cardiopulmonary Bypass', '64 neonates (median weight 3.2\xa0kg, range 2.2-4.3) contributed 290 plasma methylprednisolone concentrations (range 1.07-12,700\xa0ng/mL) and IL-6 (0-681\xa0pg/mL) and IL-10 (0.1-1125\xa0pg/mL']","['plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations', 'placebo', 'Methylprednisolone', 'methylprednisolone']",['IL-6 and stimulated IL-10 production'],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0033268'}]",,0.235628,Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit.,"[{'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dumond', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12470']
506,31874736,The cardiac output optimisation following liver transplant (COLT) trial: a feasibility randomised controlled trial.,"BACKGROUND


Perioperative goal directed fluid therapy (GDFT) has been shown to reduce postoperative complications following major surgery; this intervention has not been formally evaluated in the setting of liver transplantation.
METHODS


We conducted a prospective trial of GDFT following liver transplantation randomising patients with liver cirrhosis to either 12 h of GDFT using non-invasive cardiac output monitoring or standard care (SC). The primary outcome was feasibility. Secondary outcomes included survival, postoperative complications (Clavien-Dindo), quality of life (by EQ-5D-5L) and resource use. Trial specific follow up occurred at 90 and 180 days after surgery.
RESULTS


The study was feasible. Of 224 eligible patients, 122 were approached, 114 consented to participate and 60 were enrolled into the trial. The mean (SD) volume of IV crystalloid administered to the GDFT group during the 12-h study period was 3968 (2073) ml for the GDFT group and 2510 (1026) ml for the SC group. As regards secondary outcomes there was no difference in survival or overall complication rates. There was no significant difference in quality of life scores and resource use between the groups.
CONCLUSION


A randomised study of GDFT following liver transplantation is feasible. A post-trial stakeholder meeting supported proceeding with a full multi-centre trial.",2020,"There was no significant difference in quality of life scores and resource use between the groups.
","['liver transplantation randomising patients with liver cirrhosis to either 12\xa0h of GDFT using non-invasive cardiac output monitoring or standard care (SC', '1026', '224 eligible patients, 122 were approached, 114 consented to participate and 60 were enrolled into the trial', 'group and 2510']","['fluid therapy (GDFT', 'GDFT']","['quality of life scores and resource use', 'survival or overall complication rates', 'survival, postoperative complications (Clavien-Dindo), quality of life (by EQ-5D-5L) and resource use', 'mean (SD) volume']","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C3875571', 'cui_str': 'Non-invasive cardiac output monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",122.0,0.369461,"There was no significant difference in quality of life scores and resource use between the groups.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Koti', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Kurinchi', 'Initials': 'K', 'LastName': 'Gurusamy', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Longworth', 'Affiliation': 'PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK.'}, {'ForeName': 'Jeshika', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK; Health Economics Research Group, Brunel University, Uxbridge, UB8 3PH, UK.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Froghi', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Fiammetta', 'Initials': 'F', 'LastName': 'Soggiu', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Schofield', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Selves', 'Affiliation': 'Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Thorburn', 'Affiliation': 'Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Eastgate', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Helder', 'Initials': 'H', 'LastName': 'Filipe', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McNeil', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Anastasiou', 'Affiliation': 'Department of Statistical Science, University College London, Gower St, London, WC1E 6BT, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK. Electronic address: b.davidson@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2019.11.011']
507,32151333,"De-implementation strategy to reduce inappropriate use of intravenous and urinary catheters (RICAT): a multicentre, prospective, interrupted time-series and before and after study.","BACKGROUND


Catheter-associated bloodstream infections and urinary tract infections are frequently encountered health care-associated infections. We aimed to reduce inappropriate use of catheters to reduce health care-associated infections.
METHODS


In this multicentre, interrupted time-series and before and after study, we introduced a de-implementation strategy with multifaceted interventions in seven hospitals in the Netherlands. Adult patients admitted to internal medicine, gastroenterology, geriatic, oncology, or pulmonology wards, and non-surgical acute admission units, and who had a (central or peripheral) venous or urinary catheter were eligible for inclusion. One of the interventions was that nurses in the participating wards attended educational meetings on appropriate catheter use. Data on catheter use were collected every 2 weeks by the primary research physician during the baseline period (7 months) and intervention period (7 months), which were separated by a 5 month transition period. The primary outcomes were percentages of short peripheral intravenous catheters and urinary catheters used inappropriately on the days of data collection. Indications for catheter use were based on international guidelines. This study is registered with Netherlands Trial Register, NL5438.
FINDINGS


Between Sept 1, 2016, and April 1, 2018, we screened 6157 patients for inclusion, of whom 5696 were enrolled: 2650 patients in the baseline group, and 3046 in the intervention group. Inappropriate use of peripheral intravenous catheters occurred in 366 (22·0%, 95% CI 20·0 to 24·0) of 1665 patients in the baseline group and in 275 (14·4%, 12·8 to 16·0) of 1912 patients in the intervention group (incidence rate ratio [IRR] 0·65, 95% CI 0·56 to 0·77, p<0·0001). Time-series analyses showed an absolute reduction in inappropriate use of peripheral intravenous catheters from baseline to intervention periods of 6·65% (95% CI 2·47 to 10·82, p=0·011). Inappropriate use of urinary catheters occurred in 105 (32·4%, 95% CI 27·3 to 37·8) of 324 patients in the baseline group compared with 96 (24·1%, 20·0 to 28·6) of 398 patients in the intervention group (IRR 0·74, 95% CI 0·56 to 0·98, p=0·013). Time-series analyses showed an absolute reduction in inappropriate use of urinary catheters of 6·34% (95% CI -12·46 to 25·13, p=0·524).
INTERPRETATION


Our de-implementation strategy reduced inappropriate use of short peripheral intravenous catheters in patients who were not in the intensive care unit. The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size. The strategy appears well suited for broad-scale implementation to reduce health care-associated infections.
FUNDING


Netherlands Organisation for Health Research and Development.",2020,"The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size.","['patients who were not in the intensive care unit', '6157 patients for inclusion, of whom 5696 were enrolled: 2650 patients in the baseline group, and 3046 in the intervention group', 'Adult patients admitted to internal medicine, gastroenterology, geriatic, oncology, or pulmonology wards, and non-surgical acute admission units, and who had a (central or peripheral) venous or urinary catheter were eligible for inclusion', 'seven hospitals in the Netherlands', 'Between Sept 1, 2016, and April 1, 2018']",['intravenous and urinary catheters (RICAT'],"['incidence rate ratio [IRR', 'Inappropriate use of peripheral intravenous catheters', 'percentages of short peripheral intravenous catheters and urinary catheters used inappropriately on the days of data collection', 'Inappropriate use of urinary catheters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]",6157.0,0.0611152,"The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size.","[{'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Laan', 'Affiliation': 'Infectious Diseases, Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: b.j.laan@amsterdamumc.nl.'}, {'ForeName': 'Jolanda M', 'Initials': 'JM', 'LastName': 'Maaskant', 'Affiliation': 'Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ingrid J B', 'Initials': 'IJB', 'LastName': 'Spijkerman', 'Affiliation': 'Medical Microbiology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marjon J', 'Initials': 'MJ', 'LastName': 'Borgert', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Mieke H', 'Initials': 'MH', 'LastName': 'Godfried', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Berend C', 'Initials': 'BC', 'LastName': 'Pasmooij', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Opmeer', 'Affiliation': 'Clinical Research Unit, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Margreet C', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': 'Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Infectious Diseases, Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30709-1']
508,31573939,Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study).,"BACKGROUND


Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya.
OBJECTIVE


This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers.
METHODS


This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey.
RESULTS


Two study team decisions had significant implications for the success of the trial's enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were ""stuck"" at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period.
CONCLUSIONS


The ARMADILLO study's implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting.
CLINICAL TRIAL


International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148.",2019,"RESULTS


Two study team decisions had significant implications for the success of the trial's enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu.","['youth (aged 15-24 years', '660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were ""stuck"" at the language menu', 'Kwale County, Kenya', 'eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam']",[],[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0445519', 'cui_str': 'Kwale (qualifier value)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1292718', 'cui_str': 'Is a'}]",[],[],660.0,0.139368,"RESULTS


Two study team decisions had significant implications for the success of the trial's enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu.","[{'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Gonsalves', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Winnie Wangari', 'Initials': 'WW', 'LastName': 'Njeri', 'Affiliation': 'International Centre for Reproductive Health-Kenya, Mombasa, Kenya.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'Ona, Nairobi, Kenya.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Mwaisaka', 'Affiliation': 'International Centre for Reproductive Health-Kenya, Mombasa, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gichangi', 'Affiliation': 'International Centre for Reproductive Health-Kenya, Mombasa, Kenya.'}]",JMIR mHealth and uHealth,['10.2196/13005']
509,30508141,Feasibility of implementing mobile technology-delivered mental health treatment in routine adult sickle cell disease care.,"Sickle cell disease (SCD) is a severe hemoglobinopathy characterized by acute and chronic pain. Sufferers of the disease, most of whom are underrepresented minorities, are at increased risk for mental health disorders. The purpose of this study is to test the acceptability and implementation of a computerized cognitive behavioral therapy (cCBT) intervention, Beating the Blues, to improve depression, anxiety, and pain in patients with SCD. Adults with SCD and significant symptoms of depression (Patient Health Questionnaire [PHQ-9] score ≥ 10) or anxiety (Generalized Anxiety Disorder Scale [GAD-7] score ≥ 10) were eligible to participate and be randomized to either receive eight sessions of cCBT with care coach support or treatment as usual. Participants reported daily pain and mood symptoms using a mobile diary app. Depression, anxiety, and pain symptoms were assessed at 1, 3, and 6 months. Thirty patients were enrolled: 18 to cCBT, and 12 to control. The cCBT intervention was feasible to implement in clinical settings and acceptable to participants. Patients in the cCBT arm reported a marginally greater decrease in depression at 6 months (-3.82, SE = 1.30) than those in the control group (-0.50, SE = 1.60; p = .06). There were no significant effects of treatment on anxiety; however, cCBT was associated with improved daily pain reported via a mobile diary app (p = .014). cCBT, delivered via mobile device, is a feasible strategy to provide mental health care to adults living with SCD. cCBT was acceptable to the target population; was able to be implemented in real-world, nonideal conditions; and has the potential to improve patient-reported outcomes.",2020,"There were no significant effects of treatment on anxiety; however, cCBT was associated with improved daily pain reported via a mobile diary app (p = .014).","['Thirty patients were enrolled: 18 to cCBT, and 12 to control', 'patients with SCD', 'routine adult sickle cell disease care', 'adults living with SCD']","['computerized cognitive behavioral therapy (cCBT) intervention', 'cCBT intervention', 'implementing mobile technology-delivered mental health treatment', 'cCBT with care coach support or treatment as usual', 'cCBT']","['depression', 'Depression, anxiety, and pain symptoms', 'depression (Patient Health Questionnaire [PHQ-9] score ≥ 10) or anxiety', 'depression, anxiety, and pain', 'anxiety', 'daily pain', 'daily pain and mood symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",30.0,0.074803,"There were no significant effects of treatment on anxiety; however, cCBT was associated with improved daily pain reported via a mobile diary app (p = .014).","[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Jonassaint', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kemar V', 'Initials': 'KV', 'LastName': 'Prussien', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Yarboi', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Maureen S', 'Initials': 'MS', 'LastName': 'Sanger', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'J Deanna', 'Initials': 'JD', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Castro', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Nirmish', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'UCSF Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, University of California, San Francisco, CA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby107']
510,31161926,Guided Imagery for Total Knee Replacement: Responses to an Audiobook Placebo Treatment.,"The use of a placebo is the gold standard for establishing the efficacy of new treatments in randomized controlled trials (RCTs). Placebo treatments are inert; this allows specific effects of the experimental treatment to be separated from nonspecific physiological, psychological, and social effects. The aim of this study was to scrutinize the workings of an audiobook (AB) placebo treatment, which was used in a placebo-controlled, investigator-blinded, RCT of the effect of guided imagery (GI) to improve pain and function in persons undergoing total knee replacement. A secondary analysis of quantitative and narrative data collected during the RCT was performed. The AB treatment provided attention control. Participants in the AB group identified benefits-pleasant get-away, new knowledge, quiet time-out, and inspiration; however, there was also evidence of resentful demoralization, especially in the postoperative period. The use of ABs as a placebo treatment in GI RCTs should be executed with caution.",2020,"Participants in the AB group identified benefits-pleasant get-away, new knowledge, quiet time-out, and inspiration; however, there was also evidence of resentful demoralization, especially in the postoperative period.",['persons undergoing total knee replacement'],"['placebo', 'audiobook (AB) placebo', 'Placebo', 'guided imagery (GI', 'Audiobook Placebo']",['pain and function'],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.258816,"Participants in the AB group identified benefits-pleasant get-away, new knowledge, quiet time-out, and inspiration; however, there was also evidence of resentful demoralization, especially in the postoperative period.","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Umberger', 'Affiliation': 'Kent State University, OH, USA.'}, {'ForeName': 'Claire Burke', 'Initials': 'CB', 'LastName': 'Draucker', 'Affiliation': 'Indiana University, Indianapolis, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': 'Kent State University, OH, USA.'}]",Western journal of nursing research,['10.1177/0193945919852964']
511,30833381,No Evidence for Posttreatment Effects of Vitamin D and Calcium Supplementation on Risk of Colorectal Adenomas in a Randomized Trial.,"Vitamin D and calcium supplementation are postulated to have chemopreventive effects against colorectal neoplasia, yet in our previously reported randomized trial, there was no overall efficacy of calcium and/or vitamin D 3  against colorectal adenoma recurrence. It is possible vitamin D 3  and calcium chemopreventive effects are not detectable until beyond the 3- to 5-year follow-up captured in that trial. Accordingly, we explored possible vitamin D and calcium effects on posttreatment (observational) adenoma occurrence. In this secondary analysis of the observational follow-up phase of the Vitamin D/Calcium Polyp Prevention Study, participants who completed the treatment phase were invited to be followed for one additional surveillance colonoscopy cycle. We evaluated adenoma occurrence risk at surveillance colonoscopy, with a mean of 55 ± 15 months after treatment follow-up, according to randomized treatment with vitamin D versus no vitamin D, calcium versus no calcium, and calcium plus vitamin D versus calcium alone. Secondary outcomes included advanced and multiple adenomas. Among the 1,121 participants with observational follow-up, the relative risk (95% confidence interval, CI) of any adenoma was 1.04 (0.93-1.17) for vitamin D versus no vitamin D; 0.95 (0.84-1.08) for calcium versus no calcium; 1.07 (0.91-1.25) for calcium plus vitamin D versus calcium; and 0.96 (0.81-1.15) for calcium plus vitamin D versus neither. Risks of advanced or multiple adenomas also did not differ by treatment. Our results do not support an association between supplemental calcium and/or vitamin D 3  for 3 to 5 years and risk of recurrent colorectal adenoma at an average of 4.6 years after treatment.",2019,Risks of advanced or multiple adenomas also did not differ by treatment.,['participants who completed the treatment phase were invited to be followed for one additional surveillance colonoscopy cycle'],"['vitamin D versus no vitamin D, calcium versus no calcium, and calcium plus vitamin D versus calcium alone', 'Vitamin D and Calcium Supplementation', 'Vitamin D and calcium supplementation']","['advanced and multiple adenomas', 'Risk of Colorectal Adenomas', 'recurrent colorectal adenoma', 'Risks of advanced or multiple adenomas']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",1121.0,0.149733,Risks of advanced or multiple adenomas also did not differ by treatment.,"[{'ForeName': 'Audrey H', 'Initials': 'AH', 'LastName': 'Calderwood', 'Affiliation': 'Section of Gastroenterology and Hepatology, Department of Medicine, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. audrey.h.calderwood@hitchcock.org.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Departments of Epidemiology and Medicine, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire; University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Ahnen', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Denver, Colorado.'}, {'ForeName': 'Roberd M', 'Initials': 'RM', 'LastName': 'Bostick', 'Affiliation': 'Department of Epidemiology, Emory University; Winship Cancer Institute, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Figueiredo', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Passarelli', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Rees', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Robertson', 'Affiliation': 'VA Medical Center, White River Junction, Vermont; Section of Gastroenterology and Hepatology, Department of Medicine, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0023']
512,31035190,Clonazepam for probable REM sleep behavior disorder in Parkinson's disease: A randomized placebo-controlled trial.,"BACKGROUND


Clonazepam is considered to be a first-line treatment for rapid eye movement sleep-related behavior disorder (RBD) in Parkinson's disease (PD). The purpose of this study was to determine the short-term efficacy and safety of clonazepam for the treatment of probable RBD (pRBD) in patients with PD.
METHODS


We conducted a four-week, randomized, double-blind, placebo-controlled trial of clonazepam (0.5 mg/day at bedtime) compared to a placebo for RBD symptoms in patients with PD. Patients aged 30 years or older who had a caregiver that could observe RBD symptoms were recruited between April 2015 and February 2016. The primary outcome was the Clinical Global Impressions-Improvement (CGII) score at week four, and we compared scores between the clonazepam and placebo groups.
RESULTS


A total of 40 patients were enrolled, with 20 assigned to receive clonazepam and 20 to receive the placebo. The CGI-I score at four weeks indicated an improvement in RBD symptoms in both the clonazepam (median score [minimum, maximum] = 2 [1,5]) and placebo (3 [1,6]) groups, with no significant difference between the groups (p = .253). The secondary outcomes were not significantly different between the clonazepam and placebo groups.
CONCLUSIONS


Both clonazepam and placebo tended toward improvement on pRBD symptoms in patients with PD. No firm conclusion on efficacy of clonazepam was drawn due to limitations in the study design. This study emphasized the importance of conducting future large-scale, randomized trials with better assessment tools and polysomnography to provide evidence for the benefit of clonazepam.",2019,"The secondary outcomes were not significantly different between the clonazepam and placebo groups.
","['Patients aged 30\u202fyears or older who had a caregiver that could observe RBD symptoms were recruited between April 2015 and February 2016', 'A total of 40 patients were enrolled, with 20 assigned to receive', ""probable REM sleep behavior disorder in Parkinson's disease"", 'patients with PD']","['Clonazepam', 'clonazepam', 'clonazepam and placebo', 'placebo']","['Clinical Global Impressions-Improvement (CGII) score', 'pRBD symptoms', 'RBD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0751772', 'cui_str': 'REM Behavior Disorder'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0009011', 'cui_str': 'Clonazepam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.721686,"The secondary outcomes were not significantly different between the clonazepam and placebo groups.
","[{'ForeName': 'Chaewon', 'Initials': 'C', 'LastName': 'Shin', 'Affiliation': 'Department of Neurology, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeyoung', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Seoul Central Clinic, Seoul, Republic of Korea.'}, {'ForeName': 'Woong-Woo', 'Initials': 'WW', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Eulji General Hospital, 68 Hangeulbiseong-ro, Nowon-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun-Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, MRC and Movement Disorder Center, Seoul National University Hospital, Parkinson Study Group, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Han-Joon', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, MRC and Movement Disorder Center, Seoul National University Hospital, Parkinson Study Group, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: movement@snu.ac.kr.'}, {'ForeName': 'Beomseok', 'Initials': 'B', 'LastName': 'Jeon', 'Affiliation': 'Department of Neurology, MRC and Movement Disorder Center, Seoul National University Hospital, Parkinson Study Group, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Journal of the neurological sciences,['10.1016/j.jns.2019.04.029']
513,30840085,Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.,"Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ≤18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48 hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (≥4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.",2019,The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury.,"['Fifty-six adult patients', 'A supraregional level 1 trauma center', 'patients with major lower extremity trauma (iPACT-E-Trauma) and 2']","['Hybrid Web-Based and In-Person Self-management Intervention', 'intervention or an educational pamphlet']","['Mean scores of mild pain intensity and pain interference with daily activities', 'pain', 'Hospital Anxiety and Depression Scale scores', 'Chronic Pain Transition', 'pain intensity and pain interference with activities', 'Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score\u2009<\u200930) and anxiety and depression', 'attrition rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",56.0,0.127151,The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bérubé', 'Affiliation': 'Faculty of Nursing, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gélinas', 'Affiliation': 'Faculty of Nursing, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Feeley', 'Affiliation': 'Ingram School of Nursing, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Martorella', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': ""Centre de Recherche, Centre Hospitalier de l'Université Montréal (CRCHUM), Montréal, Québec, Canada.""}, {'ForeName': 'G Y', 'Initials': 'GY', 'LastName': 'Laflamme', 'Affiliation': ""Hôpital du Sacré-Cœur de Montréal, Centre Intégré Universitaire du Nord de l'Île-de-Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Rouleau', 'Affiliation': ""Hôpital du Sacré-Cœur de Montréal, Centre Intégré Universitaire du Nord de l'Île-de-Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Choinière', 'Affiliation': ""Centre de Recherche, Centre Hospitalier de l'Université Montréal (CRCHUM), Montréal, Québec, Canada.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz008']
514,30199451,"How to Improve Change-of-Direction Speed in Junior Team Sport Athletes-Horizontal, Vertical, Maximal, or Explosive Strength Training?","Keller, S, Koob, A, Corak, D, von Schöning, V, and Born, DP. How to improve change-of-direction speed in junior team sport athletes-Horizontal, vertical, maximal, or explosive strength training? J Strength Cond Res 34(2): 473-482, 2020-The purpose of the study was to compare the effects of 4 different training methods on change-of-direction (COD) speed in junior team sport athletes. Specifically, we investigated whether horizontal load training incorporating lateral acceleration and deceleration would induce superior performance adaptations with respect to COD speed, compared with common vertically oriented maximal strength (squats and deadlifts), explosive strength (power clean and high pull), and vertical jumping exercises. Male U15 team sport athletes (n = 45) were assigned to 1 of 4 groups and performed 2 intervention training sessions per week for 4 weeks, in addition to their usual sport-specific training. Before and after the training period, COD speed, countermovement and drop jump heights, 1-legged lateral jump, and standing long jump performance were assessed. All 4 training groups improved COD speed (p ≤ 0.01, effect size [ES] ≥1.35). Countermovement and 1-legged lateral jump performance improved with the horizontal load (p < 0.01, ES = 0.81 and p < 0.01, ES = 1.36), maximal (p = 0.01, ES = 0.56 and p < 0.01, ES = 1.14), and explosive strength training (p < 0.01, ES = 0.95 and p < 0.01, ES = 1.60, respectively). The standing long jump improved with the maximal (p < 0.01, ES = 1.14) and explosive strength training (p < 0.01, ES = 0.60). In conclusion, all 4 training methods improved the COD speed in junior U15 team sport athletes. These findings emphasize the importance of well-developed lower-body strength and power, which contribute to fast COD speed. From a practical perspective, conditioning programs for junior athletes can incorporate horizontally and vertically oriented exercises with similar effectiveness on COD speed.",2020,"All 4 training groups improved COD speed (p ≤ 0.01, effect size [ES] ≥1.35).","['junior team sport athletes', 'Male U15 team sport athletes (n = 45', 'junior athletes']","['J Strength Cond Res XX(X', 'COD speed, compared with common vertically oriented maximal strength (squats and deadlifts), explosive strength (power clean and high pull), and vertical jumping exercises', 'intervention training sessions per week for 4 weeks, in addition to their usual sport-specific training']","['change-of-direction (COD) speed', 'COD speed, countermovement and drop jump heights, 1-legged lateral jump, and standing long jump performance', 'standing long jump', 'Keller, S, Koob, A, Corak, D, von Schöning, V, and Born, DP', 'COD speed', 'Countermovement and 1-legged lateral jump performance', 'explosive strength training']","[{'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0444950', 'cui_str': 'High pull (physical object)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",45.0,0.0170675,"All 4 training groups improved COD speed (p ≤ 0.01, effect size [ES] ≥1.35).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Keller', 'Affiliation': 'Integrative and Experimental Exercise Science, Institute for Sport Sciences, University of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Koob', 'Affiliation': ''}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Corak', 'Affiliation': ''}, {'ForeName': 'Valerian', 'Initials': 'V', 'LastName': 'von Schöning', 'Affiliation': ''}, {'ForeName': 'Dennis-Peter', 'Initials': 'DP', 'LastName': 'Born', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002814']
515,30476335,The search for the ejecting chair: a mixed-methods analysis of tool use in a sedentary behavior intervention.,"Research is needed on interventions targeting sedentary behavior with appropriate behavior-change tools. The current study used convergent sequential mixed methods (QUAN + qual) to explore tool use during a edentary behavior intervention. Data came from a two-arm randomized sedentary behavior pilot intervention. Participants used a number of intervention tools (e.g., prompts and standing desks). Separate mixed-effects regression models explored associations between change in number of tools and frequency of tool use with two intervention targets: change in sitting time and number of sit-to-stand transitions overtime. Qualitative data explored participants' attitudes towards intervention tools. There was a significant relationship between change in total tool use and sitting time after adjusting for number of tools (β = -12.86, p = .02), demonstrating that a one-unit increase in tool use was associated with an almost 13 min reduction in sitting time. In contrast, there was a significant positive association between change in number of tools and sitting time after adjusting for frequency of tool use (β = 63.70, p = .001), indicating that increasing the number of tools without increasing frequency of tool use was associated with more sitting time. Twenty-four semistructured interviews were coded and a thematic analysis revealed four themes related to tool use: (a) prompts to disrupt behavior; (b) tools matching the goal; (c) tools for sit-to-stand were ineffective; and (d) tool use evolved over time. Participants who honed in on effective tools were more successful in reducing sitting time. Tools for participants to increase sit-to-stand transitions were largely ineffective. This study is registered at clincialtrials.gov. Identifier: NCT02544867.",2020,"There was a significant relationship between change in total tool use and sitting time after adjusting for number of tools (β = -12.86, p = .02), demonstrating that a one-unit increase in tool use was associated with an almost 13 min reduction in sitting time.",[],[],"['number of tools and sitting time', 'sitting time', 'successful in reducing sitting time', 'total tool use and sitting time', 'sitting time and number of sit-to-stand transitions overtime']",[],[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C2961731', 'cui_str': 'Overtime'}]",,0.0337136,"There was a significant relationship between change in total tool use and sitting time after adjusting for number of tools (β = -12.86, p = .02), demonstrating that a one-unit increase in tool use was associated with an almost 13 min reduction in sitting time.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Godbole', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Nebeker', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Madanat', 'Affiliation': 'Graduate School of Public Health, San Diego State University (SDSU), San Diego, CA, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby106']
516,30142133,Yoga Breathing Techniques Have No Impact on Isokinetic and Isoinertial Power.,"Wooten, SV, Cherup, N, Mazzei, N, Patel, S, Mooney, K, Rafiq, A, and Signorile, JF. Yoga breathing techniques have no impact on isokinetic and isoinertial power. J Strength Cond Res 34(2): 430-439, 2020-As an exercise discipline, yoga incorporates breathing (pranayama) and posture (asana) techniques to facilitate improvements in flexibility, strength, and meditation. Both techniques have been used to enhance muscular strength and power output. The purpose of this study was to determine the effects of various yoga breathing techniques on lower-limb power output. Thirty-two individuals (15 men and 17 women) participated in the study. All subjects performed a baseline 1 repetition maximum (1RM) on a pneumatic leg press machine and isokinetic testing on a Biodex 4 dynamometer. Participants then performed 3RM power tests at 50% of 1RM on the pneumatic leg press machine using 3 different yoga breathing techniques (Ujjayi, Bhastrika, and Kapalabhati) and normal breathing (control) across all repetitions. After power testing, participants completed an isokinetic test on the Biodex 4 dynamometer using their dominant leg. Subjects had their knee placed at a predetermined starting position (90°) and executed knee extension at 3 randomized testing speeds (60, 180, and 300°·s). The implementation of specific breathing protocols before and during the leg press produced no significant differences in power output. For isokinetic power measured at 60, 180, and 300°·s, there was a significant difference among testing speeds (η = 0.639; p < 0.0001) and a significant sex × speed interaction (η = 0.064; p < 0.0001), where men consistently demonstrated greater isoinertial power, isokinetic power, isokinetic torque, and isokinetic work than women. No other significant differences or interactions were detected. The differences between our study and others, which have concluded that adopting specific breathing techniques can enhance core stability and force production during lifting, may be attributable to the acute nature of the design, the novice participants who had insufficient time to practice the breathing techniques or testing protocols, and the use of tests that isolated specific muscle groups. Nonetheless, the current findings do not support the use of yoga breathing techniques as a method to enhance power output, whether used before or during power performance.",2020,"For isokinetic power measured at 60, 180, and 300°·s, there was a significant difference among testing speeds (η = 0.639; p < 0.0001) and a significant sex × speed interaction (η = 0.064; p < 0.0001), where men consistently demonstrated greater isoinertial power, isokinetic power, isokinetic torque, and isokinetic work than women.","['Thirty-two individuals (15 men and 17 women) participated in the study', 'Subjects had their knee placed at a predetermined starting position (90°) and executed knee extension at 3 randomized testing speeds (60, 180, and 300°·s']","['Yoga breathing techniques', 'J Strength Cond Res XX(X', 'various yoga breathing techniques', 'pneumatic leg press machine using 3 different yoga breathing techniques (Ujjayi, Bhastrika, and Kapalabhati) and normal breathing (control', 'exercise discipline, yoga incorporates breathing (pranayama) and posture (asana) techniques', 'pneumatic leg press machine and isokinetic testing on a Biodex 4 dynamometer']","['flexibility, strength, and meditation', 'testing speeds', 'Wooten, SV, Cherup, N, Mazzei, N, Patel, S, Mooney, K, Rafiq, A, and Signorile, JF', 'isoinertial power, isokinetic power, isokinetic torque, and isokinetic work', 'For isokinetic power']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0231795', 'cui_str': 'Normal respiratory function (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0150277'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0043227', 'cui_str': 'Work'}]",,0.0260101,"For isokinetic power measured at 60, 180, and 300°·s, there was a significant difference among testing speeds (η = 0.639; p < 0.0001) and a significant sex × speed interaction (η = 0.064; p < 0.0001), where men consistently demonstrated greater isoinertial power, isokinetic power, isokinetic torque, and isokinetic work than women.","[{'ForeName': 'Savannah V', 'Initials': 'SV', 'LastName': 'Wooten', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sports Sciences, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cherup', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sports Sciences, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Nicolle', 'Initials': 'N', 'LastName': 'Mazzei', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sports Sciences, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Shareen', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sports Sciences, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Kiersten', 'Initials': 'K', 'LastName': 'Mooney', 'Affiliation': 'Green Monkey Yoga, Miami, Florida.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rafiq', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sports Sciences, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Signorile', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sports Sciences, University of Miami, Coral Gables, Florida.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002771']
517,30161086,Influence of Menthol on Recovery From Exercise-Induced Muscle Damage.,"Gillis, DJ, Vellante, A, Gallo, JA, and D'Amico, AP. Influence of menthol on recovery from exercise-induced muscle damage. J Strength Cond Res 34(2): 451-462, 2020-This study assessed the influence of menthol, a cold receptor agonist, on recovery from exercise-induced muscle damage (EIMD). Forty-seven healthy males were allocated to a Control (CON, n = 18), Placebo (P, n = 14), or 4.0% Menthol (M, n = 15) condition. Participants were familiarized with a testing battery (TB) including: perception of lower-body muscle soreness, hip flexion/abduction range of motion, vertical jump (VJ), and the agility T-test. Muscle damage was induced on day 1 using 40 × 15-m sprints with a 5-m deceleration zone. The TB immediately followed this and was repeated once-daily for 5 days. Over this time, participants in M and P applied gels to the lower body immediately after sprinting and twice-daily thereafter, whereas CON did nothing. Dependent variables were compared by condition using the Kruskal-Wallis test (α = 0.05), and mean differences with 90% confidence intervals were calculated with small, moderate, and large effects. A significant difference by condition (p < 0.05) in muscle soreness was found, and moderate to large effects were observed in the reduction of muscle soreness with P, compared with M or CON, indicating a placebo effect. A reduction in VJ height across all conditions was observed, with a significant effect (p < 0.05) by condition, and moderate to large effects (1-5 cm) were observed in its preservation with menthol, compared with P or CON. No other differences were observed. These findings raise the possibility that menthol influences recovery of lower-body power after EIMD, and this may have practical implications for menthol's use when recovery of muscle power is important.",2020,"A significant difference by condition (p < 0.05) in muscle soreness was found, and moderate to large effects were observed in the reduction of muscle soreness with P, compared with M or CON, indicating a placebo effect.",['Forty-seven healthy males'],"['menthol, a cold receptor agonist, on recovery from exercise-induced muscle damage (EIMD', 'J Strength Cond Res XX(X', 'Placebo', 'menthol', 'Menthol']","['VJ height', ""Gillis, DJ, Vellante, A, Gallo, JA, and D'Amico, AP"", 'muscle soreness', 'Muscle damage', 'testing battery (TB) including: perception of lower-body muscle soreness, hip flexion/abduction range of motion, vertical jump (VJ), and the agility T-test']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]",47.0,0.0413916,"A significant difference by condition (p < 0.05) in muscle soreness was found, and moderate to large effects were observed in the reduction of muscle soreness with P, compared with M or CON, indicating a placebo effect.","[{'ForeName': 'D Jason', 'Initials': 'DJ', 'LastName': 'Gillis', 'Affiliation': 'Human Performance Laboratory, Department of Sport and Movement Science, Salem State University, Salem, Massachusetts.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Vellante', 'Affiliation': 'Human Performance Laboratory, Department of Sport and Movement Science, Salem State University, Salem, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Gallo', 'Affiliation': 'Athletic Training, Department of Sport and Movement Science, Salem State University, Salem, Massachusetts.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'DʼAmico', 'Affiliation': 'Human Performance Laboratory, Department of Sport and Movement Science, Salem State University, Salem, Massachusetts.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002833']
518,31420412,TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7).,"BACKGROUND


Primary cytoreductive surgery followed by chemotherapy has been considered standard management for patients with advanced ovarian cancer over decades. An alternative approach of interval debulking surgery following neoadjuvant chemotherapy was subsequently reported by two randomized phase III trials (EORTC-GCG, CHORUS), which were criticized owing to important limitations, especially regarding the rate of complete resection.
PRIMARY OBJECTIVE


To clarify the optimal timing of surgical therapy in advanced ovarian cancer.
STUDY HYPOTHESIS


Primary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer.
TRIAL DESIGN


TRUST is an international open, randomized, controlled multi-center trial investigating overall survival after primary cytoreductive surgery versus neoadjuvant chemotherapy and subsequent interval cytoreductive surgery in patients with FIGO stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma. To guarantee adequate surgical quality, participating centers need to fulfill specific quality assurance criteria (eg, ≥50% complete resection rate in upfront surgery for FIGO IIIB-IVB patients, ≥36 debulking-surgeries/year) and agree to independent audits by TRUST quality committee delegates. Patients in the primary cytoreductive surgery arm undergo surgery followed by 6 cycles of platinum-based chemotherapy, whereas patients in the interval cytoreductive surgery arm undergo 3 cycles of neoadjuvant chemotherapy after histologic confirmation of the disease, followed by interval cytoreductive surgery and subsequently, 3 cycles of platinum-based chemotherapy. The intention of surgery for both groups is complete tumor resection according to guideline recommendations.
MAJOR INCLUSION/EXCLUSION CRITERIA


Major inclusion criteria are suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma FIGO stage IIIB-IVB (IV only if resectable metastasis). Major exclusion criteria are non-epithelial ovarian malignancies and borderline tumors; prior chemotherapy for ovarian cancer; or abdominal/pelvic radiotherapy.
PRIMARY ENDPOINT


Overall survival.
SAMPLE SIZE


772 patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Accrual completion approximately mid-2019, results are expected after 5 years' follow-up in 2024.
TRIAL REGISTRATION


NCT02828618.",2019,"Primary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer.
","['772 patients', 'advanced ovarian cancer', 'advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7', 'Major inclusion criteria are suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma FIGO stage IIIB-IVB (IV only if resectable metastasis', 'patients with advanced ovarian cancer', 'patients with FIGO stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma']","['Radical Upfront Surgical Therapy', 'interval cytoreductive surgery arm undergo 3 cycles of neoadjuvant chemotherapy', 'platinum-based chemotherapy', 'primary cytoreductive surgery arm undergo surgery followed by 6 cycles of platinum-based chemotherapy', 'interval debulking surgery following neoadjuvant chemotherapy', 'primary cytoreductive surgery versus neoadjuvant chemotherapy and subsequent interval cytoreductive surgery', 'interval cytoreductive surgery', 'neoadjuvant chemotherapy', 'surgical therapy', 'TRUST']","['Overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",772.0,0.3548,"Primary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': 'AGO Study Group and Coordinating Centre for Clinical Trials, Philipps-Universität Marburg, Marburg, Germany alexander.reuss@kks.uni-marburg.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'AGO Study Group and Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'AGO Study Group and Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fotopoulou', 'Affiliation': 'AGO Study Group and West London Gynecological Cancer Centre; Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'AGO Study Group and Department of Gynecologic Oncology, Charite Comprehensive Cancer Center Berlin, Berlin, Germany.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Aletti', 'Affiliation': 'MANGO and Department of Gynecology, Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Guyon', 'Affiliation': 'GINECO and Institut Bergonie, Bordeaux, France.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Greggi', 'Affiliation': 'Department of Gynecologic Oncology Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Berit Jul', 'Initials': 'BJ', 'LastName': 'Mosgaard', 'Affiliation': 'NSGO and Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'AGO Study Group and Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': 'AGO Study Group and Coordinating Centre for Clinical Trials, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'AGO Study Group and Gynecology Service, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'AGO Study Group and Department of Obstetrics and Gynecology, University Hospital, Ludwig Maximilians University Munich, Munich, Bayern, Germany.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000682']
519,31984762,Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial.,"BACKGROUND/AIMS


In clinical trials, participant retention is critical to reduce bias and maintain statistical power for hypothesis testing. Within a multi-center clinical trial of diabetic retinopathy, we investigated whether regular phone calls to participants from the coordinating center improved long-term participant retention.
METHODS


Among 305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants were randomly assigned to receive phone calls at baseline, 6 months, and annually through 3 years (annual contact group) while 153 participants were assigned to receive a phone call at baseline only (baseline contact group). All participants could be contacted if visits were missed. The main outcomes were visit completion, excluding deaths, at 2 years (the primary outcome time point) and at 5 years (the final time point).
RESULTS


At baseline, 77% (117 of 152) of participants in the annual contact group and 76% (116 of 153) in the baseline contact group were successfully contacted. Among participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125) were contacted successfully by telephone around the time of the 1-, 2-, and 3-year visits, respectively. In the annual and baseline contact groups, completion rates for the 2-year primary outcome visit were 88% (129 of 147) versus 87% (125 of 144), respectively, with a risk ratio of 1.01 (95% confidence interval: 0.93-1.10,  p  = .81). At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93). At 2 years, the completion rate of participants successfully contacted at baseline was 89% (202 of 226) versus 80% (52 of 65) among those not contacted successfully (risk ratio = 1.12, 95% confidence interval = 0.98-1.27,  p  = .09); at 5 years, the completion percentages by baseline contact success were 69% (148 of 213) versus 56% (36 of 64; risk ratio = 1.24, 95% confidence interval = 0.98-1.56,  p  = .08).
CONCLUSION


Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention.",2020,"At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93).","['305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants', 'participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125']",['telephone calls'],"['visit completion, excluding deaths', 'completion rates', 'completion rate']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",152.0,0.554304,"At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93).","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Leanne T', 'Initials': 'LT', 'LastName': 'Labriola', 'Affiliation': 'Department of Ophthalmology, Carle Foundation Hospital, College of Medicine, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Oliver', 'Affiliation': 'Southeastern Retina Associates, Knoxville, TN, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519894229']
520,30741862,Sprint Training on a Treadmill vs. Overground Results in Modality-Specific Impact on Sprint Performance but Similar Positive Improvement in Body Composition in Young Adults.,"Dorgo, S, Perales, JJ, Boyle, JB, Hausselle, J, and Montalvo, S. Sprint training on a treadmill vs. overground results in modality-specific impact on sprint performance but similar positive improvement in body composition in young adults. J Strength Cond Res 34(2): 463-472, 2020-The effects of different sprint training modalities on body composition are not yet known, and the effectiveness of using motorized treadmills for sprint training is yet to be assessed accurately. The following study investigated the effects of motorized treadmill and overground training on sprint performance and body composition. Sixty-four young adults (33 men and 31 women) completed 12 sprint training sessions over a 6-week period either on a treadmill (TM) or overground (TR), or followed their normal exercise routine (CONTROL). Fifty-yard sprint time, 20-yard maximal sprint speed split time, and maximal treadmill speed were used as sprint performance indicators. Body composition and sprint performance assessments were completed before and after the 6-week intervention. On completion of the 6-week training program, maximal treadmill speed significantly increased for all 3 groups, while split sprint time significantly decreased for the TR group. The CONTROL group's 50-yd sprint time and split sprint time significantly worsened after 6 weeks. Improvements in sprint time and speed were significantly greater for the TR and TM groups compared with the CONTROL group for 50-yd sprint time, 20-yard maximal sprint speed split time, and maximal treadmill sprint speed. The change in maximal treadmill sprint speed for the TM group was significantly greater than that of the TR group. TR and TM subjects also showed significant decrease in total body fat and increase in leg lean muscle mass. These findings indicate that although overground sprint training resulted in the greatest performance improvements within overground sprint tests, sprint training on a motorized treadmill may be a beneficial alternative modality to overground sprint training and may also positively impact subjects' body composition.",2020,"Improvements in sprint time and speed were significantly greater for the TR and TM groups compared with the CONTROL group for 50-yd sprint time, 20-yard maximal sprint speed split time, and maximal treadmill sprint speed.","['Young Adults', 'young adults', 'Sixty-four young adults (33 men and 31 women']","['motorized treadmill and overground training', '12 sprint training sessions over a 6-week period either on a treadmill (TM) or overground (TR), or followed their normal exercise routine (CONTROL', 'J Strength Cond Res XX(X', 'overground sprint training', 'Sprint Training', 'sprint training modalities']","['split sprint time', '50-yd sprint time and split sprint time', 'maximal treadmill speed', 'Body composition and sprint performance assessments', 'maximal treadmill sprint speed', 'Fifty-yard sprint time, 20-yard maximal sprint speed split time, and maximal treadmill speed', 'body composition', 'total body fat', 'sprint time and speed', 'sprint performance and body composition', 'Body Composition', '50-yd sprint time, 20-yard maximal sprint speed split time, and maximal treadmill sprint speed', 'leg lean muscle mass']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0454374', 'cui_str': 'Sprint training (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0560016', 'cui_str': 'yd3'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}]",64.0,0.0155816,"Improvements in sprint time and speed were significantly greater for the TR and TM groups compared with the CONTROL group for 50-yd sprint time, 20-yard maximal sprint speed split time, and maximal treadmill sprint speed.","[{'ForeName': 'Sandor', 'Initials': 'S', 'LastName': 'Dorgo', 'Affiliation': 'Department of Kinesiology, University of Texas at El Paso, El Paso, Texas.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Perales', 'Affiliation': 'Department of Kinesiology, University of Texas at El Paso, El Paso, Texas.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Boyle', 'Affiliation': 'Department of Kinesiology, University of Texas at El Paso, El Paso, Texas.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Hausselle', 'Affiliation': 'School of Mechanical and Aerospace Engineering, Oklahoma State University, Stillwater, Oklahoma.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montalvo', 'Affiliation': 'Department of Kinesiology, University of Texas at El Paso, El Paso, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003024']
521,31973934,Comparison of effectiveness coolant spray and placebo in patients with acute ankle trauma prospective randomized controlled trial.,"INTRODUCTION


Coolant spray application in musculoskeletal injuries is an effective and harmless method to treat pain and reduce functional limitation. This study assessed the clinical value of coolant spray application on patient comfort before and during the radiographic imaging process along with its early analgesic and anti-edema effects.
METHODS


A total of 155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study. The patients were randomly assigned to either a coolant spray or a saline spray (placebo) group. To the coolant spray group patients, Cryos ®Spray (Phyto Performance, Italy) was applied. To the placebo group patients, a normal saline solution in a bottle covered with white opaque paper and refrigerated at 4 °C was sprayed. Radiographic images of the patients were scored for appropriateness of the standard imaging characteristics.
RESULTS


The mean scores were 8.13 ± 1.8 and 6.58 ± 2.2 for the coolant spray and normal saline spray groups, respectively; the differences were statistically significant between the two groups (mean difference: -1.56, 95% CI:-2.20 to -0.92; p = .000). Patients with fractures on their radiographs and treated with coolant spray received higher scores than similar patients treated with normal saline spray (mean difference:-1.92, 95% CI:-3.28 to -0.55; p = .009). The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
CONCLUSIONS


The radiographic images taken after coolant spray intervention in patients with acute ankle trauma were more successful in showing the target structures.",2020,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
","['155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study', 'patients with acute ankle trauma']","['coolant spray or a saline spray (placebo', 'placebo', 'normal saline solution', 'normal saline spray', 'coolant spray']","['proportion of patients requesting analgesic treatment before discharge', 'mean scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",155.0,0.112359,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
","[{'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: sultantuna@hotmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Kutsi', 'Initials': 'K', 'LastName': 'Tuncer', 'Affiliation': 'Orthopedics and Traumatology, Department of Orthopedics and Traumatology, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Karabulut', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.12.054']
522,30199658,Risk Factors for Post-Traumatic Stress Disorder Symptoms in Surrogate Decision-Makers of Patients with Chronic Critical Illness.,"RATIONALE


Chronically critically ill patients are often dependent on family members for surrogate decision-making, and these surrogates are at high risk for emotional distress. We hypothesized that patient- and surrogate-specific risk factors for surrogate post-traumatic stress disorder (PTSD) symptoms can be identified early in the course of chronic critical illness.
OBJECTIVES


To identify risk factors for PTSD symptoms in surrogate decision-makers of chronically critically ill patients.
METHODS


We performed a secondary analysis of the database from a multicenter randomized trial of a communication intervention for chronic critical illness patients and surrogates. Variables preselected for plausible mechanism for increasing PTSD symptoms and identifiable by Day 10 of mechanical ventilation were included in the analysis for association with surrogate PTSD symptoms at 90 days, as measured by the Impact of Events Score-Revised (IES-R). Patient factors included demographics, insurance status, baseline functional status, chronic comorbidities, illness severity, and presence of advance directive. Surrogate variables included demographics, education level and employment, religion, relationship to patient, and Hospital Anxiety and Depression Scale score measured at enrollment. Multivariable linear regression models were then constructed for 26 potential risk factors, including biologically or mechanistically plausible confounders for each, with IES-R score as the outcome. All models were adjusted for multiple respondents, using a mixed model, considering the patients as a random factor.
RESULTS


Our analysis included 306 surrogates for 224 patients. A total of 49% of patients were female, and mean age was 59 years (95% confidence interval [CI], 56.4-60.7). A total of 71% of surrogates were female, and mean age was 51 years (95% CI, 49.3-52.4). After examining each potential risk factor in a separate multivariable model, only Day-10 surrogate Hospital Anxiety and Depression Scale score (β coefficient = 1.02; 95% CI, 0.73-1.30) and patient unresponsiveness (β coefficient = 8.39; 95% CI, 0.83-15.95) were associated with higher IES-R scores.
CONCLUSIONS


Among surrogate decision-makers for chronically critically ill patients, high anxiety and depression scores and patient unresponsiveness on or near Day 10 of mechanical ventilation are risk factors for PTSD symptoms at 90 days.",2018,"Among surrogate decision-makers for chronically critically ill patients, high anxiety and depression scores and patient unresponsiveness on or near Day 10 of mechanical ventilation are risk factors for PTSD symptoms at 90 days.","['Chronically critically ill patients', 'A total of 71% of surrogates were female, and mean age was 51 years (95% CI, 49.3-52.4', 'Patients with Chronic Critical Illness', 'chronic critical illness patients and surrogates', '306 surrogates for 224 patients', 'chronically critically ill patients']",['communication intervention'],"['higher IES-R scores', 'demographics, insurance status, baseline functional status, chronic comorbidities, illness severity, and presence of advance directive', 'Day-10 surrogate Hospital Anxiety and Depression Scale score', 'demographics, education level and employment, religion, relationship to patient, and Hospital Anxiety and Depression Scale score']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}]","[{'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0682141', 'cui_str': 'Church - religion'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",306.0,0.157409,"Among surrogate decision-makers for chronically critically ill patients, high anxiety and depression scores and patient unresponsiveness on or near Day 10 of mechanical ventilation are risk factors for PTSD symptoms at 90 days.","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Wendlandt', 'Affiliation': '1 University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Ceppe', 'Affiliation': '1 University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': '1 University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Nelson', 'Affiliation': '2 Memorial Sloan Kettering Cancer Center and Weill-Cornell Medical College, New York, New York.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': '3 Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': '1 University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Danis', 'Affiliation': '4 National Institutes of Health, Bethesda, Maryland; and.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': ""5 Dana Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Carson', 'Affiliation': '1 University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201806-420OC']
523,31279845,Safety and varicella outcomes after varicella zoster immune globulin administration in pregnancy.,,2019,,['pregnancy'],['varicella zoster immune globulin'],['Safety and varicella outcomes'],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0740380', 'cui_str': 'Varicella zoster'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008049', 'cui_str': 'Varicella'}]",,0.0596064,,"[{'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, NC. Electronic address: geeta.swamy@duke.edu.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Dotters-Katz', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, NC.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.07.003']
524,31979567,Eff ectiveness of Teneligliptin as an Add-on in T2DM Patients not Controlled on Metformin and Glimepiride.,,2020,,[],"['Metformin and Glimepiride', 'Teneligliptin']",[],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C2981308'}]",[],,0.0134403,,"[{'ForeName': 'Pranjal', 'Initials': 'P', 'LastName': 'Kashiv', 'Affiliation': 'Narayan Medical College and Hospital, Sasaram.'}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Narayan Medical College and Hospital, Sasaram.'}]",The Journal of the Association of Physicians of India,[]
525,32406655,Three-Dimensional Volumetric Changes After Socket Augmentation with Deproteinized Bovine Bone and Collagen Matrix.,"PURPOSE


Socket augmentation decreases the magnitude of alveolar ridge resorption, but the literature is limited in respect to quantifying soft tissue remodeling. The aim of this study was to determine the volumetric and linear dimensional changes at the buccal surface for both hard and soft tissues after socket augmentation treated with a xenogeneic collagen matrix in combination with bone grafting.
MATERIALS AND METHODS


Twenty-four individuals indicated for tooth extraction were enrolled in this investigation. Each participant was randomly assigned to one of two groups: (1) deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix. A cone beam computed tomography scan was taken prior to extraction and at 6 months postextraction. Intraoral scanning images were taken at baseline, 3 months, and 6 months postextraction. Hard and soft tissue analyses were performed to compare linear ridge remodeling and volumetric changes by noncontact reverse-engineering software.
RESULTS


Both groups showed bone and soft tissue remodeling. For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups. For soft tissue remodeling, the collagen matrix group showed a reduced soft tissue loss compared with the collagen plug group. The volumetric analysis demonstrated that the mean buccal soft tissue volume loss for the collagen matrix group was 68.6 mm 3  compared with 87.6 mm 3  found in the collagen plug group (P = .009) over a 6-month period.
CONCLUSION


This clinical investigation provides early evidence of using the total tissue volume to compare soft and hard tissue remodeling after socket augmentation. The results of this study demonstrated that the use of a xenogeneic collagen matrix reduced the buccal soft tissue loss after tooth extraction, but additional studies are necessary to evaluate the clinical significance of soft tissue augmentation after tooth extraction.",2020,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.",['Twenty-four individuals indicated for tooth extraction were enrolled in this investigation'],"['Deproteinized Bovine Bone and Collagen Matrix', 'xenogeneic collagen matrix', 'deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix']","['mean buccal soft tissue volume loss', 'alveolar ridge resorption', 'soft tissue loss', 'bone and soft tissue remodeling', 'buccal soft tissue loss']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0182324', 'cui_str': 'Plug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",24.0,0.0170066,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.","[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Morelli', 'Affiliation': ''}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Monaghan', 'Affiliation': ''}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marchesan', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7961']
526,30222518,Access to Dermatological Care with an Innovative Online Model for Psoriasis Management: Results from a Randomized Controlled Trial.,"Background:   Many patients with chronic skin diseases lack regular access to dermatologists in the United States and suffer poor clinical outcomes.   Introduction:   We performed a 12-month randomized controlled trial to evaluate the impact of an online, collaborative connected health (CCH) model for psoriasis management on access to specialty care.   Materials and Methods:   The 300 enrolled patients were randomized to online or in-person care. We compared distance traveled as well as transportation and in-office waiting time between the two groups and obtained patient and provider perspectives on CCH.   Results:   At baseline, no differences existed between the groups in difficulties obtaining specialty care. Over 12 months, the mean (standard deviation [SD]) distance traveled to and from appointments was 174.8 (±577.4) km/person for the in-person group and 2.2 (±14.2) km/person for the online group ( p  = 0.0003). The mean (SD) time spent on transportation and in-office waiting for in-person appointments was 4.0 (±4.5) h/person for the in-person group and 0.1 (±0.4) h/person for the online group ( p  = 0.0001). Patients found CCH to be safe, accessible, equitable, efficient, effective, and patient-centered. Providers found CCH to be useful for providing psoriasis care.   Discussion:   The CCH model resulted in significantly less distance traveled as well as transportation and in-office waiting time compared to in-person care. Both patients and providers were highly satisfied with CCH.   Conclusions:   The CCH model resulted in increased access to specialty care and enabled patient-centered, safe, and effective management of psoriasis patients.",2019,The CCH model resulted in significantly less distance traveled as well as transportation and in-office waiting time compared to in-person care.,"['300 enrolled patients', 'Psoriasis Management', 'patients with chronic skin diseases']","['online, collaborative connected health (CCH) model', 'CCH']",['mean (SD) time spent on transportation and in-office waiting'],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1290009', 'cui_str': 'Chronic disease of skin'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]",300.0,0.10247,The CCH model resulted in significantly less distance traveled as well as transportation and in-office waiting time compared to in-person care.,"[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Ford', 'Affiliation': '1 Department of Dermatology, Keck School of Medicine of the University of Southern California, Los Angeles, California.'}, {'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'Gibbons', 'Affiliation': '1 Department of Dermatology, Keck School of Medicine of the University of Southern California, Los Angeles, California.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Torres', 'Affiliation': '1 Department of Dermatology, Keck School of Medicine of the University of Southern California, Los Angeles, California.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Kornmehl', 'Affiliation': '2 Department of Dermatology, Drexel University College of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sanminder', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': '3 Department of Dermatology, University of California Davis School of Medicine, Sacramento, California.'}, {'ForeName': 'Paulina M', 'Initials': 'PM', 'LastName': 'Young', 'Affiliation': '1 Department of Dermatology, Keck School of Medicine of the University of Southern California, Los Angeles, California.'}, {'ForeName': 'Cindy J', 'Initials': 'CJ', 'LastName': 'Chambers', 'Affiliation': '3 Department of Dermatology, University of California Davis School of Medicine, Sacramento, California.'}, {'ForeName': 'Emanual', 'Initials': 'E', 'LastName': 'Maverakis', 'Affiliation': '3 Department of Dermatology, University of California Davis School of Medicine, Sacramento, California.'}, {'ForeName': 'Cory A', 'Initials': 'CA', 'LastName': 'Dunnick', 'Affiliation': '4 Department of Dermatology, University of Colorado School of Medicine, University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': '1 Department of Dermatology, Keck School of Medicine of the University of Southern California, Los Angeles, California.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0160']
527,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5']
528,32406658,Influence of the Dimensions of the Antrostomy on Osseointegration of Mini-implants Placed in the Grafted Region After Sinus Floor Elevation: A Randomized Clinical Trial.,"PURPOSE


To evaluate the osseointegration of mini-implants placed in grafted sinuses with lateral windows of two different dimensions.
MATERIALS AND METHODS


Sinus floor augmentation was performed in volunteers using a lateral window. The antrostomy was systematically prepared with a height of either 8 mm (large group) or 4 mm (small group). After 6 months of healing, mini-implants were placed in the grafted region. Biopsy specimens including the mini-implants were harvested 3 months after placement.
RESULTS


Twenty biopsy specimens, 10 from each group, were suitable for the histologic analysis. Similar amounts of new bone-to-implant contact were obtained in both the large (41.1% ± 19.5%) and the small (42.8% ± 13.2%) groups (P = .940). Small percentages of residues of xenograft were found in contact with the implant surface, with 0.6% ± 1.1% in the large group and 5.9% ± 9.5% in the small group (P = .098). The new bone density around the implants was 31.7% ± 8.2% and 34.0% ± 7.9% in the large and small groups, respectively (P = .623).
CONCLUSION


The dimensions of the antrostomy did not influence the histologic healing of implants placed 6 months after sinus floor augmentation.",2020,The dimensions of the antrostomy did not influence the histologic healing of implants placed 6 months after sinus floor augmentation.,['Sinus floor augmentation was performed in volunteers using a lateral window'],[],"['histologic healing', 'new bone density', 'Small percentages of residues of xenograft']","[{'cui': 'C3178819', 'cui_str': 'Sinus Augmentation Therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0557702', 'cui_str': 'Window'}]",[],"[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}]",,0.0382678,The dimensions of the antrostomy did not influence the histologic healing of implants placed 6 months after sinus floor augmentation.,"[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': ''}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Iezzi', 'Affiliation': ''}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Piattelli', 'Affiliation': ''}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Ferri', 'Affiliation': ''}, {'ForeName': 'Karol Alí Apaza', 'Initials': 'KAA', 'LastName': 'Alccayhuaman', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Botticelli', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.8005']
529,32406659,Masticatory Efficiency in Implant-Supported Fixed Complete Dentures Compared with Conventional Dentures: A Randomized Clinical Trial by Color-Mixing Analysis Test.,"PURPOSE


To compare the masticatory efficiency of an All-on-4 prosthesis with complete dentures on a Class I ridge with a color-mixing analysis test.
MATERIALS AND METHODS


Ten patients with fixed complete dentures on implants and an additional 10 patients with conventional complete dentures on a Class I ridge (Atwood) chewed a bicolor chewing gum (Hubba Bubba) for different numbers of cycles (5, 10, 15, and 20). The chewed gum was retrieved, scanned, and weighted to quantify masticatory efficiency.
RESULTS


This study showed higher values for implant-supported fixed complete dentures than conventional complete dentures. These findings were significant with the color-mixing test in cycles 5 and 10 between both groups. The reduction in weight was not significantly different between the two groups but was noteworthy in intercycle comparison.
CONCLUSION


Implant-supported fixed complete dentures showed superior masticatory efficiency compared with conventional complete dentures constructed over well-formed ridges in the early chewing cycles.",2020,"CONCLUSION


Implant-supported fixed complete dentures showed superior masticatory efficiency compared with conventional complete dentures constructed over well-formed ridges in the early chewing cycles.","['Implant-Supported Fixed Complete Dentures', 'Ten patients with fixed complete dentures on implants and an additional 10 patients with conventional complete dentures on a Class I ridge (Atwood) chewed a bicolor chewing gum (Hubba Bubba) for different numbers of cycles (5, 10, 15, and 20']",['Conventional Dentures'],"['reduction in weight', 'masticatory efficiency', 'superior masticatory efficiency', 'Masticatory Efficiency']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0457285', 'cui_str': 'Conventional denture'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",10.0,0.0321325,"CONCLUSION


Implant-supported fixed complete dentures showed superior masticatory efficiency compared with conventional complete dentures constructed over well-formed ridges in the early chewing cycles.","[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Jasser', 'Affiliation': ''}, {'ForeName': 'Zahraa', 'Initials': 'Z', 'LastName': 'Salami', 'Affiliation': ''}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'El Hage', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makzoumé', 'Affiliation': ''}, {'ForeName': 'Paul Jamil', 'Initials': 'PJ', 'LastName': 'Boulos', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7911']
530,32067401,Respiratory outcomes with the use of a lower custom fit genioglossal-effecting oral appliance.,"OBJECTIVE


Sleep apnea research cites that an oral appliance, which places the mandible in a more forward position and the genioglossus (tongue muscle) on the floor of the mouth, improves aspects of the pharyngeal opening. Exercise science research has cited improvements in airway dynamics and physiological variables with oral appliance use during exercise. Thus, the purpose of this study was to design an oral appliance that would act on the genioglossus and determine if there were effects on respiratory parameters while exercising.
MATERIALS AND METHODS


Seventeen healthy subjects ages 18-43 participated in this study. Prior to the exercise protocol, the order of the oral applicance (OA) or no oral appliance (no OA) condition was randomly assigned to subjects, with subjects completing both conditions. Respiratory parameters (respiratory rate, ventilation, oxygen, and carbon dioxide) were measured between conditions while subjects ran for 10 min at steady state.
RESULTS


The results demonstrated that both respiratory rate (25.97 BPM, OA and 28.35 BPM, no OA) and ventilation (47.66 l/min, OA and 50.34 l/min, No OA) were significantly lowered (p < .01) in the OA condition. There were no differences in carbon dioxide (1.89 l/min, no OA and 1.88 l/min, OA) or oxygen outcomes (2.17 l/min, no OA and 2.17 l/min OA).
DISCUSSION


The outcomes from this study suggest that the design of the oral appliance elicits an effect on the genioglossus, thereby resulting in lowered respiratory rate and ventilation with no negative effects on oxygen uptake during exercise.",2020,"There were no differences in carbon dioxide (1.89 l/min, no OA and 1.88 l/min, OA) or oxygen outcomes (2.17 l/min, no OA and 2.17 l/min OA).
",['Seventeen healthy subjects ages 18-43 participated in this study'],"['oral applicance (OA) or no oral appliance (no OA', 'lower custom fit genioglossal-effecting oral appliance']","['oxygen uptake', 'respiratory rate (25.97 BPM, OA and 28.35 BPM, no OA) and ventilation', 'Respiratory parameters (respiratory rate, ventilation, oxygen, and carbon dioxide', 'OA) or oxygen outcomes', 'carbon dioxide']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]",17.0,0.0207753,"There were no differences in carbon dioxide (1.89 l/min, no OA and 1.88 l/min, OA) or oxygen outcomes (2.17 l/min, no OA and 2.17 l/min OA).
","[{'ForeName': 'Dena P', 'Initials': 'DP', 'LastName': 'Garner', 'Affiliation': 'Department of Health and Human Performance, the Citadel, The Citadel, Charleston, South Carolina.'}, {'ForeName': 'Jensine', 'Initials': 'J', 'LastName': 'Lamira', 'Affiliation': 'Department of Health and Human Performance, the Citadel, The Citadel, Charleston, South Carolina.'}]",Clinical and experimental dental research,['10.1002/cre2.254']
531,31425454,Changes in Torque-Angle Profiles of the Hamstrings and Hamstrings-to-Quadriceps Ratio After Two Hamstring Strengthening Exercise Interventions in Female Hockey Players.,"Delextrat, A, Bateman, J, Ross, C, Harman, J, Davis, L, Vanrenterghem, J, and Cohen, DD. Changes in torque-angle profiles of the hamstrings and hamstrings-to-quadriceps ratio after two hamstring strengthening exercise interventions in female hockey players. J Strength Cond Res 34(2): 396-405, 2020-The aim of this study was to compare the effects of 2 hamstring strengthening interventions (Nordic hamstrings [NHE] vs. eccentric leg curl [ELC]) on the hamstring torque-angle profiles and functional hamstrings-to-quadriceps ratio (Hecc:Qcon) in female hockey players. Female university-level players were randomly allocated to an NHE group (n = 9, 19.7 ± 1.4 years; 168.4 ± 4.4 cm; 66.2 ± 7.2 kg, 26.0 ± 4.4%), an ELC group (n = 8, 19.5 ± 1.0 years; 168.1 ± 3.4 cm; 66.7 ± 4.5 kg, 24.8 ± 3.5%), or a control (C) group (n = 8, 19.6 ± 1.4 years; 169.9 ± 7.5 cm; 70.7 ± 13.0 kg, 25.9 ± 5.2%). They performed baseline isokinetic concentric strength tests of the quadriceps (Qcon) and eccentric strength of the hamstrings (Hecc) at 120°·s, followed by a 6-week intervention with exercises (NHE or ELC) performed 3 times weekly, before post-tests. Analyses of variance with repeated measures were used to assess the effects of knee position angle (from 90° of knee flexion to 10° close to extension), group, and time on Qcon, Hecc, and Hecc:Qcon. There were no interactions between independent variables. Significant increases in Hecc and Hecc:Qcon were shown after NHE (+29.9 and +27.8%) and ELC (+30.5 and +38.3%) in the nondominant leg only. Furthermore, significant shifts in the hamstring eccentric angle of peak torque toward a longer muscle length were shown in both legs (14.3-28.6%). These findings suggest that NHE and ELC both resulted in significant improvements in peak and muscle-length-specific neuromuscular risk factors in the nondominant (ND) limb, thereby reducing interlimb peak strength asymmetries. Strength and conditioning specialists could therefore use both the NHE and ELC exercises in female hockey players.",2020,"Furthermore, significant shifts in the hamstring eccentric angle of peak torque toward a longer muscle length were shown in both legs (14.3-28.6%).","['female hockey players', 'Female university-level players', 'Female Hockey Players']","['2 hamstring strengthening interventions (Nordic hamstrings [NHE] vs. eccentric leg curl [ELC', 'Two Hamstring Strengthening Exercise Interventions', 'hamstring strengthening exercise interventions', 'baseline isokinetic concentric strength tests of the quadriceps (Qcon) and eccentric strength of the hamstrings (Hecc) at 120°·s, followed by a 6-week intervention with exercises (NHE or ELC', 'NHE and ELC', 'NHE and ELC exercises', 'J Strength Cond Res XX(X', 'ELC', 'NHE', 'functional hamstrings-to-quadriceps ratio (Hecc:Qcon']","['Hecc and Hecc:Qcon', 'peak and muscle-length-specific neuromuscular risk factors', 'Torque-Angle Profiles of the Hamstrings and Hamstrings-to-Quadriceps Ratio', 'hamstring eccentric angle of peak torque toward a longer muscle length']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0019828', 'cui_str': 'Hockeys'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.0242931,"Furthermore, significant shifts in the hamstring eccentric angle of peak torque toward a longer muscle length were shown in both legs (14.3-28.6%).","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Delextrat', 'Affiliation': 'Faculty of Sport and Health Sciences and Social Work, Oxford Brookes University, Oxford, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bateman', 'Affiliation': 'Faculty of Sport and Creative Services University College Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ross', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Harman', 'Affiliation': 'Faculty of Sport and Health Sciences and Social Work, Oxford Brookes University, Oxford, United Kingdom.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Davis', 'Affiliation': 'Faculty of Sport and Health Sciences and Social Work, Oxford Brookes University, Oxford, United Kingdom.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Vanrenterghem', 'Affiliation': 'Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Cohen', 'Affiliation': 'Faculty of Life Sciences, University of Santander (UDES), Bucaramanga, Colombia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003309']
532,30431535,In-Season Integrative Neuromuscular Strength Training Improves Performance of Early-Adolescent Soccer Athletes.,"Panagoulis, C, Chatzinikolaou, A, Avloniti, A, Leontsini, D, Deli, CK, Draganidis, D, Stampoulis, T, Oikonomou, T, Papanikolaou, K, Rafailakis, L, Kambas, A, Jamurtas, AZ, and Fatouros, IG. In-season integrative neuromuscular strength training improves performance of early-adolescent soccer athletes. J Strength Cond Res 34(2): 516-526, 2020-Although forms of integrative neuromuscular training (INT) are used extensively for injury prevention and treatment, no information exists about its effects on performance of adolescent athletes. We investigated the effects of an in-season INT intervention on performance of early-adolescent players using a 2-group, repeated-measures design. Twenty-eight early adolescents were randomly assigned to a control group (CG, participated only in soccer training, N = 14, 11.4 ± 0.57 years, Tanner stage 2.8 ± 0.6) or an experimental group (INT was added to conventional soccer training, N = 14, 11.2 ± 0.5 years, Tanner stage 2.6 ± 0.5). Integrative neuromuscular training (8 weeks, 3 sessions·wk) aimed to develop core strength, hamstrings eccentric strength, hip/knee musculature, and dynamic stability using body mass exercises, medicine balls, rocker boards, Bosu, stability balls, etc. Ball shooting speed, speed (10, 20-m), change of direction (COD), jumping performance, and strength were measured before and after training. A 2-way repeated-measures ANOVA was used to analyze data. Integrative neuromuscular training improved 10- and 20-m speed (2.52-2.13 and 3.61-3.39 seconds, respectively, p < 0.05), strength (40.1-44.4 kg, p < 0.05), jumping ability (squat jump: 16.3-17.9 cm; countermovement jump: 19.1-20.3 cm, p < 0.05), COD (18.0-17.3 seconds, p < 0.05), and shooting speed (73.8-79.0 km·h, p < 0.05). In the CG, soccer training caused an improvement of smaller magnitude in 10 m and shooting speed (p < 0.05), whereas COD and jumping performance remained unaffected while 20-m speed, COD, and strength deteriorated. These results indicate that an 8-week INT program may induce positive adaptations in performance of early-adolescent soccer players during in-season training, suggesting that INT may be an effective training intervention for this age group.",2020,"Integrative neuromuscular training improved 10- and 20-m speed (2.52-2.13 and 3.61-3.39 seconds, respectively, p < 0.05), strength (40.1-44.4 kg, p < 0.05), jumping ability (squat jump: 16.3-17.9 cm; countermovement jump: 19.1-20.3 cm, p < 0.05), COD (18.0-17.3 seconds, p < 0.05), and shooting speed (73.8-79.0 km·h, p < 0.05).","['Twenty-eight early adolescents', 'early-adolescent soccer athletes', 'early-adolescent players', 'Early-Adolescent Soccer Athletes', 'early-adolescent soccer players']","['integrative neuromuscular training (INT', 'Season Integrative Neuromuscular Strength Training', 'control group (CG', 'J Strength Cond Res XX(X', 'experimental group (INT was added to conventional soccer training', 'INT program', 'season integrative neuromuscular strength training', 'season INT intervention', 'Integrative neuromuscular training']","['COD', 'shooting speed', 'COD and jumping performance remained unaffected while 20-m speed, COD, and strength deteriorated', 'strength', 'Ball shooting speed, speed (10, 20-m), change of direction (COD), jumping performance, and strength', 'smaller magnitude in 10 m and shooting speed', 'Panagoulis, C, Chatzinikolaou, A, Avloniti, A, Leontsini, D, Deli, CK, Draganidis, D, Stampoulis, T, Oikonomou, T, Papanikolaou, K, Rafailakis, L, Kambas, A, Jamurtas, AZ, and Fatouros, IG']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",28.0,0.0159877,"Integrative neuromuscular training improved 10- and 20-m speed (2.52-2.13 and 3.61-3.39 seconds, respectively, p < 0.05), strength (40.1-44.4 kg, p < 0.05), jumping ability (squat jump: 16.3-17.9 cm; countermovement jump: 19.1-20.3 cm, p < 0.05), COD (18.0-17.3 seconds, p < 0.05), and shooting speed (73.8-79.0 km·h, p < 0.05).","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Panagoulis', 'Affiliation': 'Department of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': 'Department of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Avloniti', 'Affiliation': 'Department of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Diamanda', 'Initials': 'D', 'LastName': 'Leontsini', 'Affiliation': 'Department of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Stampoulis', 'Affiliation': 'Department of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Oikonomou', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papanikolaou', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Lefteris', 'Initials': 'L', 'LastName': 'Rafailakis', 'Affiliation': 'Department of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Kambas', 'Affiliation': 'Department of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002938']
533,31974770,Psychological intervention in patients with advanced cancer at home through Individual Meaning-Centered Psychotherapy-Palliative Care: a pilot study.,"OBJECTIVE


To compare Individual Meaning-Centered Psychotherapy-Palliative Care (IMCP-PC) to counselling-based psychotherapy in patients receiving home palliative care (PC).
METHODS


Fifty-one patients with advanced-stage cancer receiving home PC were recruited for this. Two-arm (individual meaning-centered psychotherapy-palliative-IMCP-PC-care vs. counselling) randomized feasibility trial. Anxiety, depression, demoralization, and emotional distress were evaluated before and after three psychotherapy sessions. Patient perceptions of the treatment were assessed after completion of therapy.
RESULTS


Thirty-two patients (16 in each group) completed all three sessions as well as the pre- and post-therapy questionnaires and were therefore included in the final analysis. All patients in the IMCP-PC group showed a significant decrease in levels of demoralization (despair), anxiety, depression, and emotional distress. By contrast, the only variable that significantly improved in the counselling group was demoralization. The post-treatment questionnaire revealed no significant between-group differences regarding patient perception of the structure, focus, or length of treatment. However, the IMCP-PC group rated the treatment more highly with regard to its value in helping them to find meaning in life.
CONCLUSIONS


IMCP-PC is a specific psychotherapy tailored to the needs of patients with advanced cancer. The results of the present study indicate that this treatment is suitable for patients at end of life that are not able to attend outpatient sessions. Although more research is needed, the findings of this feasibility trial suggest that the IMCP-PC merits consideration for patients receiving home palliative care (PC).",2020,"All patients in the IMCP-PC group showed a significant decrease in levels of demoralization (despair), anxiety, depression, and emotional distress.","['patients with advanced cancer', 'Fifty-one patients with advanced-stage cancer receiving home PC were recruited for this', 'patients with advanced cancer at home through Individual Meaning-Centered Psychotherapy-Palliative Care', 'patients receiving home palliative care (PC']","['Psychological intervention', 'Individual Meaning-Centered Psychotherapy-Palliative Care (IMCP-PC) to counselling-based psychotherapy', 'IMCP-PC']","['patient perception of the structure, focus, or length of treatment', 'Anxiety, depression, demoralization, and emotional distress', 'levels of demoralization (despair), anxiety, depression, and emotional distress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233498', 'cui_str': 'Demoralization (finding)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",51.0,0.0323008,"All patients in the IMCP-PC group showed a significant decrease in levels of demoralization (despair), anxiety, depression, and emotional distress.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fraguell-Hernando', 'Affiliation': 'EAPS Mutuam Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joaquín T', 'Initials': 'JT', 'LastName': 'Limonero', 'Affiliation': 'Stress and Health Research Group, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain. joaquin.limonero@uab.cat.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil', 'Affiliation': 'Stress and Health Research Group, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05322-2']
534,31274775,The Effect of Levosimendan Versus Milrinone on the Occurrence Rate of Acute Kidney Injury Following Congenital Heart Surgery in Infants: A Randomized Clinical Trial.,"OBJECTIVES


It has been shown that, in contrast to other inotropic agents, levosimendan improves glomerular filtration rate after adult cardiac surgery. The aim of this study was to investigate the efficacy of levosimendan, compared with milrinone, in preventing acute kidney dysfunction in infants after open-heart surgery with cardiopulmonary bypass.
DESIGN


Two-center, double-blinded, prospective, randomized clinical trial.
SETTING


The study was performed in two tertiary pediatric centers, one in Sweden (Gothenburg) and one in Finland (Helsinki).
PATIENTS


Infants between 1 and 12 months old, diagnosed with Tetralogy of Fallot, complete atrioventricular septal defect or nonrestrictive ventricular septal defect, undergoing total corrective cardiac surgery with cardiopulmonary bypass.
INTERVENTIONS


Seventy-two infants were randomized to receive a perioperative infusion of levosimendan (0.1 µg/kg/min) or milrinone (0.4 µg/kg/min). The infusion was initiated at the start of cardiopulmonary bypass and continued for 26 hours.
MEASUREMENTS AND MAIN RESULTS


The primary outcome variable was the absolute value of serum creatinine data on postoperative day 1. Secondary outcomes included the following: 1) acute kidney injury according to the serum creatinine criteria of the Kidney Diseases: Improving Global Outcomes; 2) acute kidney injury with serum creatinine corrected for fluid balance; 3) plasma neutrophil gelatinase-associated lipocalin; 4) cystatin C; 5) urea; 6) lactate; 7) hemodynamic variables; 8) use of diuretics in the PICU; 9) need of dialysis; 10) length of ventilator therapy; and 11) length of PICU stays. There was no significant difference in postoperative serum creatinine between the treatment groups over time (p = 0.65). The occurrence rate of acute kidney injury within 48 hours was 46.9% in the levosimendan group and 39.5% in the milrinone group (p = 0.70). There were no significant differences in other secondary outcome variables between the groups.
CONCLUSIONS


Levosimendan compared with milrinone did not reduce the occurrence rate of acute kidney injury in infants after total corrective heart surgery for atrioventricular septal defect, ventricular septal defect, or Tetralogy of Fallot.",2019,There was no significant difference in postoperative serum creatinine between the treatment groups over time (p = 0.65).,"['after adult cardiac surgery', 'Seventy-two infants', 'infants after open-heart surgery with cardiopulmonary bypass', 'Infants between 1 and 12 months old, diagnosed with Tetralogy of Fallot, complete atrioventricular septal defect or nonrestrictive ventricular septal defect, undergoing total corrective cardiac surgery with cardiopulmonary bypass', 'Acute Kidney Injury Following Congenital Heart Surgery in Infants', 'two tertiary pediatric centers, one in Sweden (Gothenburg) and one in Finland (Helsinki', 'infants after total corrective heart surgery for atrioventricular septal defect, ventricular septal defect, or Tetralogy of Fallot']","['perioperative infusion of levosimendan', 'milrinone', 'levosimendan', 'Levosimendan Versus Milrinone', 'Levosimendan']","['absolute value of serum creatinine data on postoperative day 1', '1) acute kidney injury according to the serum creatinine criteria of the Kidney Diseases: Improving Global Outcomes; 2) acute kidney injury with serum creatinine corrected for fluid balance; 3) plasma neutrophil gelatinase-associated lipocalin; 4) cystatin C; 5) urea; 6) lactate; 7) hemodynamic variables; 8) use of diuretics in the PICU; 9) need of dialysis; 10) length of ventilator therapy; and 11) length of PICU stays', 'postoperative serum creatinine', 'glomerular filtration rate', 'acute kidney dysfunction', 'occurrence rate of acute kidney injury']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0344787', 'cui_str': 'Atrioventricular septal defect: atrial and ventricular components (disorder)'}, {'cui': 'C0018818', 'cui_str': 'Intraventricular Septal Defects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C1389018', 'cui_str': 'AVSD'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0128513', 'cui_str': 'Milrinone'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",72.0,0.266398,There was no significant difference in postoperative serum creatinine between the treatment groups over time (p = 0.65).,"[{'ForeName': 'Elin M', 'Initials': 'EM', 'LastName': 'Thorlacius', 'Affiliation': ""Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg and Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.""}, {'ForeName': 'Pertti K', 'Initials': 'PK', 'LastName': 'Suominen', 'Affiliation': ""Department of Anesthesia and Intensive Care, Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland.""}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Wåhlander', 'Affiliation': ""Department of Pediatric Cardiology, Sahlgrenska Academy, University of Gothenburg and Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.""}, {'ForeName': 'Juho', 'Initials': 'J', 'LastName': 'Keski-Nisula', 'Affiliation': ""Department of Anesthesia and Intensive Care, Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vistnes', 'Affiliation': 'Department of Internal Medicine, Diakonhjemmet Hospital and Institute for Experimental Medical Research, Oslo University Hospital and University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': ""Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg and Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.""}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Synnergren', 'Affiliation': ""Department of Pediatric Thoracic Surgery, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.""}, {'ForeName': 'Birgitta S', 'Initials': 'BS', 'LastName': 'Romlin', 'Affiliation': ""Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg and Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Castellheim', 'Affiliation': ""Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg and Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.""}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002017']
535,31962052,Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial.,"INTRODUCTION


Dental anxiety is common and causes symptomatic use of oral health services.
OBJECTIVES


The aim was to study if a short-term virtual reality intervention reduced preoperative dental anxiety.
METHODS


A randomized controlled single-center trial was conducted with 2 parallel arms in a public oral health care unit: virtual reality relaxation (VRR) and treatment as usual (TAU). The VRR group received a 1- to 3.5-min 360° immersion video of a peaceful virtual landscape with audio features and sound supporting the experience. TAU groups remained seated for 3 min. Of the powered sample of 280 participants, 255 consented and had complete data. Total and secondary sex-specific mixed effects linear regression models were completed for posttest dental anxiety (Modified Dental Anxiety Scale [MDAS] total score) and its 2 factors (anticipatory and treatment-related dental anxiety) adjusted for baseline (pretest) MDAS total and factor scores and age, taking into account the effect of blocking.
RESULTS


Total and anticipatory dental anxiety decreased more in the VRR group than the TAU group (β = -0.75, P < .001, for MDAS total score; β = -0.43, P < .001, for anticipatory anxiety score) in patients of a primary dental care clinic. In women, dental anxiety decreased more in VRR than TAU for total MDAS score (β = -1.08, P < .001) and treatment-related dental anxiety (β = -0.597, P = .011). Anticipatory dental anxiety decreased more in VRR than TAU in both men (β = -0.217, P < .026) and women (β = -0.498, P < .001).
CONCLUSION


Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
KNOWLEDGE TRANSFER STATEMENT


Dental anxiety, which is a common problem, can be reduced with short application of virtual reality relaxation applied preoperatively in the waiting room. Findings of this study indicate that it is a feasible and effective procedure to help patients with dental anxiety in normal public dental care settings.",2020,"Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
","['280 participants, 255 consented and had complete data', 'patients with dental anxiety in normal public dental care settings']","['VRR', 'virtual reality intervention', 'Virtual Reality Relaxation', 'public oral health care unit: virtual reality relaxation (VRR) and treatment as usual (TAU']","['Total and anticipatory dental anxiety', 'dental anxiety', 'Anticipatory dental anxiety', 'MDAS total and factor scores', 'MDAS total score', 'anticipatory anxiety score', 'posttest dental anxiety (Modified Dental Anxiety Scale [MDAS] total score) and its 2 factors (anticipatory and treatment-related dental anxiety) adjusted for baseline (pretest', 'Dental Anxiety', 'total MDAS score']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0029162'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]",280.0,0.082385,"Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lahti', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Suominen', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lähteenoja', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Humphris', 'Affiliation': 'Division of Populations and Behavioural Science, School of Medicine, University of St Andrews, St Andrews, UK.'}]",JDR clinical and translational research,['10.1177/2380084420901679']
536,31508863,Comparison of tramadol versus tramadol with paracetamol for efficacy of postoperative pain management in lumbar discectomy: A randomised controlled study.,"PURPOSE


Despite developments in the treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries remains inadequate. We aimed to compare the postoperative analgesic efficacy of tramadol versus tramadol with paracetamol after lumbar discectomy.
DESIGN, SETTING, PARTICIPANTS


Sixty patients undergoing lumbar discectomy were randomly assigned into two groups.
METHODS


Patients in Group T (n = 30) received tramadol (1 mg/kg), and patients in Group TP (n = 30) received tramadol (1 mg/kg) with paracetamol (1 g) 30 minutes before the end of surgery and paracetamol was continued during the postoperative period at 6 hours intervals for the first 24 hours. Patient-controlled analgesia with tramadol was used during the postoperative period.
MAIN OUTCOME MEASURES


Duration, postoperative pain scores, Ramsay sedation scores, analgesic consumption, and side effects were recorded in all patients during the postoperative period. Continuous random variables were tested for normal distribution using the Kolmogorov-Smirnov test, than Student's t-test was used for means comparisons between groups. For discrete random variables chi-square tests and McNemar test was used.
RESULTS


Demographic data, mean duration of anaesthesia and surgery were similar in both groups. Postoperative pain scores were significantly higher in Group T than Group TP at 5; 15; 20; and 30 minutes (P = .021, P = .004, P = .002, P = .018). Late postoperative pain scores were similar. Total tramadol consumption in Group T (106.12 ± 4.84 mg) was higher than Group TP (81.20 ± 2.53) during the 24 hours postoperative period. However, continuing the paracetamol at 6 hours interval did not change late postoperative pain scores.
CONCLUSION


The administration of tramadol with paracetamol was more effective than tramadol alone for early acute postoperative pain therapy following lumbar discectomy. Therefore, while adding paracetamol in early pain management is recommended, continuing paracetamol for the late postoperative period is not advised.",2020,"Postoperative pain scores were significantly higher in Group T than Group TP at 5; 15; 20; and 30 minutes (P = .021, P = .004, P = .002, P = .018).","['Sixty patients undergoing lumbar discectomy', 'lumbar discectomy', 'Patients in Group T (n\xa0', 'early acute postoperative pain therapy following lumbar discectomy']","['paracetamol', 'tramadol', 'tramadol with paracetamol', 'paracetamol (1\xa0g']","['Duration, postoperative pain scores, Ramsay sedation scores, analgesic consumption, and side effects', 'Total tramadol consumption', 'Late postoperative pain scores', 'mean duration of anaesthesia and surgery', 'late postoperative pain scores', 'postoperative analgesic efficacy', 'Postoperative pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",60.0,0.0769317,"Postoperative pain scores were significantly higher in Group T than Group TP at 5; 15; 20; and 30 minutes (P = .021, P = .004, P = .002, P = .018).","[{'ForeName': 'Neslihan', 'Initials': 'N', 'LastName': 'Uztüre', 'Affiliation': 'Department of Anesthesiology and Reanimation, Yeditepe University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Türe', 'Affiliation': 'Department of Anesthesiology and Reanimation, Yeditepe University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Özgül', 'Initials': 'Ö', 'LastName': 'Keskin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Yeditepe University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Başar', 'Initials': 'B', 'LastName': 'Atalay', 'Affiliation': 'Department of Neurosurgery, Yeditepe University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Köner', 'Affiliation': 'Department of Anesthesiology and Reanimation, Yeditepe University School of Medicine, Istanbul, Turkey.'}]",International journal of clinical practice,['10.1111/ijcp.13414']
537,31970310,Comparing the effects of nursing versus peer-based education methods on the preoperative anxiety in infertile women: An RCT.,"Background


Preoperative anxiety is a common event in patients expecting surgery. Education can play an important role in reducing the negative effects of anxiety on the response to treatment. Therefore, identifying the appropriate method is important.
Objective


The aim of this study was comparing the effects of nursing versus peer-based education on the preoperative anxiety in infertile women.
Materials and Methods


In this clinical trial, 198 eligible infertile women were randomized into three groups (n = 66/each): the nurse-educated, peer-educated, and the controls. The Spielberger State-Trait Anxiety Inventory was filled out by all participants for measuring the patient anxiety at the time of hospital admission and prior to surgery. Participants in the nurse-educated and peer-educated groups received a group education program by a nurse or peer, respectively, after the initial completion of the Spielberger State-Trait Anxiety Inventory.
Results


The mean score anxiety was 44.47, 46.92, and 42.60 at the time of hospital admission and 39.38, 41.06, and 43.42 prior to surgery in nurse-educated, peer-educated, and the control groups, respectively. There was a significant difference in the mean score of anxiety in each group before and after the intervention (p  <  0.0001). However, the difference between the groups was not significant.
Conclusion


Our findings demonstrate that nursing and peer education programs both reduce the preoperative anxiety. Hence, optimal use of the peer's potential regarding the compensation for staff shortage for preoperative education as well as investigating the effect of individual education is suggested for further studies.",2019,There was a significant difference in the mean score of anxiety in each group before and after the intervention (p  <  0.0001).,"['infertile women', 'patients expecting surgery', '198 eligible infertile women']","['nursing versus peer-based education methods', 'nursing versus peer-based education']","['mean score anxiety', 'preoperative anxiety', 'Spielberger State-Trait Anxiety Inventory', 'mean score of anxiety']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}]",198.0,0.0321446,There was a significant difference in the mean score of anxiety in each group before and after the intervention (p  <  0.0001).,"[{'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Farnia', 'Affiliation': 'Department of Nursing, Nursing-Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Aflatoonian', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Athareh', 'Initials': 'A', 'LastName': 'Kalantari', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i12.5795']
538,31274778,Innovation in Central Venous Access Device Security: A Pilot Randomized Controlled Trial in Pediatric Critical Care.,"OBJECTIVES


Central venous access devices enable many treatments during critical illness; however, 25% of pediatric central venous access devices fail before completion of treatment due to infection, thrombosis, dislodgement, and occlusion. This is frequently attributed to inadequate securement and dressing of the device; however, high-quality research evaluating pediatric central venous access device securement innovation to prevent central venous access device failure is scarce. This study aimed to establish the feasibility of a definitive randomized control trial examining the effectiveness of current and new technologies to secure central venous access devices in pediatrics.
DESIGN


Single-center, parallel group, superiority, pilot randomized control trial.
SETTING


Anesthetic and intensive care departments of a tertiary pediatric hospital SUBJECTS:: One-hundred eighty pediatric patients with nontunneled central venous access device INTERVENTIONS:: Participants were randomized to receive central venous access device securement via standard care (bordered polyurethane dressing, with prolene sutures, chlorhexidine gluconate disc), tissue adhesive (Histoacryl, B Braun, Melsungen, Germany) in addition to standard care; or integrated dressing securement (SorbaView SHIELD [Centurion Medical Products, Franklin, MA], with prolene sutures and chlorhexidine gluconate disc).
OUTCOMES


Primary: Feasibility (including effect size estimates, acceptability); central venous access device failure; central venous access device complications; secondary: individual central venous access device complications, skin damage, dressing performance, and product cost.
MEASUREMENTS AND MAIN RESULTS


Feasibility criteria were achieved as recruitment occurred with acceptable eligibility, recruitment, missing data, and attrition rates, as well as good protocol adherence. Family members and staff-reported comparable levels of acceptability between study arms; however, tissue adhesive was reported as the most difficult to apply. Overall, 6% of central venous access devices failed, including 6% (3/54; incident rate, 13.2 per 1,000 catheter days) standard care, 2% (1/56; incident rate, 3.65 per 1,000 catheter days) integrated, and 8% (5/59; 25.0 per 1,000 catheter days) tissue adhesive.
CONCLUSIONS


It is feasible to conduct an efficacy randomized control trial of the studied interventions. Further research is required to definitively identify clinical, cost-effective methods to prevent central venous access device failure by examining new dressing and securement technologies and techniques.",2019,"Overall, 6% of central venous access devices failed, including 6% (3/54; incident rate, 13.2 per 1,000 catheter days) standard care, 2% (1/56; incident rate, 3.65 per 1,000 catheter days) integrated, and 8% (5/59; 25.0 per 1,000 catheter days) tissue adhesive.
","['pediatrics', 'Central Venous Access Device Security', 'Anesthetic and intensive care departments of a tertiary pediatric hospital SUBJECTS:: One-hundred eighty pediatric patients with']","['central venous access device securement via standard care (bordered polyurethane dressing, with prolene sutures, chlorhexidine gluconate disc), tissue adhesive (Histoacryl, B Braun, Melsungen, Germany) in addition to standard care; or integrated dressing securement (SorbaView SHIELD [Centurion Medical Products, Franklin, MA], with prolene sutures and chlorhexidine gluconate disc', 'nontunneled central venous access device']","['effect size estimates, acceptability); central venous access device failure; central venous access device complications; secondary: individual central venous access device complications, skin damage, dressing performance, and product cost', 'acceptable eligibility, recruitment, missing data, and attrition rates, as well as good protocol adherence']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0085559'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0032616', 'cui_str': 'Ostamer'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0491217', 'cui_str': 'Sterile polypropylene monofilament suture (physical object)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C0878094', 'cui_str': 'Histoacryls'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0086138', 'cui_str': 'Device Failure'}, {'cui': 'C0850376', 'cui_str': 'Device complication'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",180.0,0.169679,"Overall, 6% of central venous access devices failed, including 6% (3/54; incident rate, 13.2 per 1,000 catheter days) standard care, 2% (1/56; incident rate, 3.65 per 1,000 catheter days) integrated, and 8% (5/59; 25.0 per 1,000 catheter days) tissue adhesive.
","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Ullman', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': ""Paediatric Critical Care Research Group, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Pearson', 'Affiliation': ""Paediatric Critical Care Research Group, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Mihala', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.'}, {'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Mattke', 'Affiliation': ""Paediatric Critical Care Research Group, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Macfarlane', 'Affiliation': ""Paediatric Critical Care Research Group, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002059']
539,31981556,Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial.,"BACKGROUND


Innovative solutions are required to provide mental health support at scale in low-resource humanitarian contexts. We aimed to assess the effectiveness of a facilitator-guided, group-based, self-help intervention (Self-Help Plus) to reduce psychological distress in female refugees.
METHODS


We did a cluster randomised trial in rural refugee settlements in northern Uganda. Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6). The intervention comprised access to usual care and five 2-h audio-recorded stress-management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book. Villages were randomly assigned to either intervention (Self-Help Plus or enhanced usual care) on a 1:1 basis. Within 14 villages, randomly selected households were approached. Screening of women in households continued until 20-30 eligible participants were identified per site. The primary outcome was individual psychological distress, assessed using the Kessler 6 symptom checklist 1 week before, 1 week after, and 3 months after intervention, in the intention-to-treat population. All outcomes were measured at the individual (rather than cluster) level. Secondary outcomes included personally identified problems, post-traumatic stress, depression symptoms, feelings of anger, social interactions with other ethnic groups, functional impairment, and subjective wellbeing. Assessors were masked to allocation. This trial was prospectively registered at ISRCTN, number 50148022.
FINDINGS


Of 694 eligible participants (331 Self-Help Plus, 363 enhanced usual care), 613 (88%) completed all assessments. Compared with controls, we found stronger improvements for Self-Help Plus on psychological distress 3 months post intervention (β -1·20, 95% CI -2·33 to -0·08; p=0·04; d -0·26). We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36). Refugees with different trauma exposure, length of time in settlements, and initial psychological distress benefited similarly. With regard to safety considerations, the independent data safety management board responded to six adverse events, and none were evaluated to be concerns in response to the intervention.
INTERPRETATION


Self-Help Plus is an innovative, facilitator-guided, group-based self-help intervention that can be rapidly deployed to large numbers of participants, and resulted in meaningful reductions in psychological distress at 3 months among South Sudanese female refugees.
FUNDING


Research for Health in Humanitarian Crises (R2HC) Programme.",2020,We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36).,"['female refugees', 'South Sudanese female refugees in Uganda', 'Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6', 'women in households continued until 20-30 eligible participants', 'rural refugee settlements in northern Uganda', '694 eligible participants (331 Self-Help Plus']","['facilitator-guided, group-based, self-help intervention (Self-Help Plus', 'Self-Help', 'usual care and five 2-h audio-recorded stress-management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book', 'intervention (Self-Help Plus or enhanced usual care']","['personally identified problems, post-traumatic stress, depression symptoms, feelings of anger, social interactions with other ethnic groups, functional impairment, and subjective wellbeing', 'psychological distress', 'individual psychological distress, assessed using the Kessler 6 symptom checklist', 'length of time in settlements, and initial psychological distress']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0241297', 'cui_str': 'Sudanese (ethnic group)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0006002', 'cui_str': 'Books'}]","[{'cui': 'C0683510', 'cui_str': 'Identifying problems (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",694.0,0.0951295,We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36).,"[{'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Peter C Alderman Program for Global Mental Health, HealthRight International, New York, NY, USA. Electronic address: wtol@jhu.edu.'}, {'ForeName': 'Marx R', 'Initials': 'MR', 'LastName': 'Leku', 'Affiliation': 'Arua, Uganda.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Lakin', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Carswell', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Jura', 'Initials': 'J', 'LastName': 'Augustinavicius', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Adaku', 'Affiliation': 'Arua, Uganda; Department of Psychiatry, Arua Regional Referral Hospital, Arua, Uganda.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Au', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Brown', 'Affiliation': 'WarChild Holland, Amsterdam, Netherlands.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Garcia-Moreno', 'Affiliation': 'Department of Reproductive Health & Research, WHO, Geneva, Switzerland.'}, {'ForeName': 'Rashelle J', 'Initials': 'RJ', 'LastName': 'Musci', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section, UN High Commissioner for Refugees, Geneva, Switzerland.'}, {'ForeName': 'Ross G', 'Initials': 'RG', 'LastName': 'White', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30504-2']
540,31962329,The Impact of Traditional Medicine-Based Lifestyle and Diet on Infertility Treatment in Women Undergoing Assisted Reproduction: A Randomized Controlled Trial.,"The problem of infertility is growing rapidly in the world. Traditional medicine with thousands of years of history has claimed that it can treat some kinds of infertility using nutritional and lifestyle modifications and interventions. The purpose of this study was to evaluate the effect of a traditional medicine-oriented diet and lifestyle on infertility treatment. Based on a clinical trial study, 180 infertile women who were 20-40 years old and candidates for in vitro fertilization (IVF) were randomly assigned to 2 groups: an intervention group and a control group. The intervention group used diet and lifestyle recommendations based on Iranian traditional medicine for at least 3 months. The number of ova, mature ovum number, embryo number, embryo quality, and fertilization rate were significantly higher in the intervention group than in the control group (for all items; p < 0.05). Overall pregnancy rate was significantly higher in the intervention group (35.2 vs. 12.4%; odds ratio [OR], 3.8; 95% CI, 1.8-8.3). The intervention group had a higher rate of getting spontaneous pregnancy than the control group (20.9 vs. 2.2%; OR, 11.5; 95% CI, 2.6-50.9). Chemical pregnancy was significantly higher in the intervention group (64 vs. 27.5%; OR, 4.7; 95% CI, 1.9-11.6). Diet and lifestyle modifications based on traditional medicine can contribute greatly to the infertility treatment. Thus, many infertility cases can be treated without the need to use advanced methods. In case of using assisted reproductive techniques, traditional medicine can enhance the efficiency of these methods.",2020,"Chemical pregnancy was significantly higher in the intervention group (64 vs. 27.5%; OR, 4.7; 95% CI, 1.9-11.6).","['Women', '180 infertile women who were 20-40 years old and candidates for in vitro fertilization (IVF']","['traditional medicine-oriented diet and lifestyle', 'Undergoing Assisted Reproduction', 'diet and lifestyle recommendations based on Iranian traditional medicine', 'Traditional Medicine-Based Lifestyle and Diet']","['Chemical pregnancy', 'rate of getting spontaneous pregnancy', 'number of ova, mature ovum number, embryo number, embryo quality, and fertilization rate', 'Overall pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0025131', 'cui_str': 'Medicine, Traditional'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",180.0,0.0821416,"Chemical pregnancy was significantly higher in the intervention group (64 vs. 27.5%; OR, 4.7; 95% CI, 1.9-11.6).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Alibeigi', 'Affiliation': 'School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Jafari-Dehkordi', 'Affiliation': 'School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soleiman', 'Initials': 'S', 'LastName': 'Kheiri', 'Affiliation': 'Modeling in Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nemati', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Mohammadi-Farsani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Tansaz', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran, tansaz_mojgan@yahoo.com.'}]",Complementary medicine research,['10.1159/000505016']
541,31387894,Effects of Inspiratory Exercise With Linear and Nonlinear Load on Respiratory Variables Post-Bariatric Surgery.,"BACKGROUND


Obesity leads to changes in respiratory function, causing reduced lung volumes and mechanical disadvantage of the respiratory muscles. We sought to evaluate the effect of breathing exercises using devices that impose linear and nonlinear load on reversing diaphragm dysfunction and the prevalence of atelectasis after bariatric surgery.
METHODS


This was a blind randomized clinical trial. Preoperatively, we assessed the subjects' maximum inspiratory pressure by measuring nasal inspiratory pressure and respiratory muscle endurance with an incremental test based on sustained maximum inspiratory pressure (sustained P Imax ) and the prevalence of atelectasis by chest radiograph. Subjects were then randomized into 2 groups: a linear load pressure group and nonlinear load pressure group; both groups received conventional respiratory physiotherapy. Subjects were reassessed on the second day after bariatric surgery.
RESULTS


We included 40 morbidly obese women (body mass index > 40 kg/m 2 ), age 25-55 years, who underwent bariatric surgery by laparotomy. The groups were homogeneous with respect to age ( P  = .11), body mass ( P  = .12), height ( P  = .75), body mass index ( P  = .75), nasal inspiratory pressure ( P  = .48), sustained P Imax  ( P  = .89), and absence of atelectasis at baseline. In the reassessment, both groups showed significant reduction in nasal inspiratory pressure ( P  < .001) and maintenance of sustained P Imax  (linear load pressure  P  = .51; nonlinear load pressure  P  = .055). The prevalence of atelectasis was 15% for linear load pressure and 25% for nonlinear load pressure, with no significant difference between groups ( P  = .69).
CONCLUSION


Both groups were able to maintain respiratory muscle endurance after bariatric surgery. In addition, the treatment contributed to controlling atelectasis so that it did not cause clinical repercussions to the subjects. (ClinicalTrials.gov registration NCT02298517).",2019,"In the reassessment, both groups showed significant reduction in nasal inspiratory pressure ( P  < .001) and maintenance of sustained P Imax  (linear load pressure  P  = .51; nonlinear load pressure  P  = .055).","[' 40 kg/m 2 ), age 25-55 years, who underwent bariatric surgery by laparotomy', '40 morbidly obese women (body mass index']","['linear load pressure group and nonlinear load pressure group; both groups received conventional respiratory physiotherapy', 'breathing exercises', 'Inspiratory Exercise With Linear and Nonlinear Load']","['body mass', 'nasal inspiratory pressure', 'prevalence of atelectasis', ""subjects' maximum inspiratory pressure by measuring nasal inspiratory pressure and respiratory muscle endurance with an incremental test based on sustained maximum inspiratory pressure (sustained P Imax ) and the prevalence of atelectasis by chest radiograph"", 'body mass index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0801024,"In the reassessment, both groups showed significant reduction in nasal inspiratory pressure ( P  < .001) and maintenance of sustained P Imax  (linear load pressure  P  = .51; nonlinear load pressure  P  = .055).","[{'ForeName': 'Eli Maria', 'Initials': 'EM', 'LastName': 'Pazzianotto-Forti', 'Affiliation': 'Graduate Program in Physical Therapy and Human Movement Sciences, School of Health Sciences, Universidade Metodista de Piracicaba, Piracicaba, São Paulo, Brazil. eli.forti@unimep.br.'}, {'ForeName': 'Carolina Moraes', 'Initials': 'CM', 'LastName': 'da Costa Munno', 'Affiliation': 'Graduate Program in Physical Therapy and Human Movement Sciences, School of Health Sciences, Universidade Metodista de Piracicaba, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Daniela Faleiros Bertelli', 'Initials': 'DFB', 'LastName': 'Merino', 'Affiliation': 'Graduate Program in Physical Therapy and Human Movement Sciences, School of Health Sciences, Universidade Metodista de Piracicaba, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Maura Rigoldi', 'Initials': 'MR', 'LastName': 'Simões da Rocha', 'Affiliation': 'Graduate Program in Physical Therapy and Human Movement Sciences, School of Health Sciences, Universidade Metodista de Piracicaba, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Tamires Alessa', 'Initials': 'TA', 'LastName': 'de Mori', 'Affiliation': 'Graduate Program in Physical Therapy and Human Movement Sciences, School of Health Sciences, Universidade Metodista de Piracicaba, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Irineu Rasera', 'Initials': 'IR', 'LastName': 'Júnior', 'Affiliation': 'Center of Gastroenterology and Obesity Surgery of Piracicaba, Piracicaba, São Paulo, Brazil.'}]",Respiratory care,['10.4187/respcare.05841']
542,31568099,A randomized controlled trial testing a virtual perspective-taking intervention to reduce race and socioeconomic status disparities in pain care.,"We conducted a randomized controlled trial of an individually tailored, virtual perspective-taking intervention to reduce race and socioeconomic status (SES) disparities in providers' pain treatment decisions. Physician residents and fellows (n = 436) were recruited from across the United States for this two-part online study. Providers first completed a bias assessment task in which they made treatment decisions for virtual patients with chronic pain who varied by race (black/white) and SES (low/high). Providers who demonstrated a treatment bias were randomized to the intervention or control group. The intervention consisted of personalized feedback about their bias, real-time dynamic interactions with virtual patients, and videos depicting how pain impacts the patients' lives. Treatment bias was re-assessed 1 week later. Compared with the control group, providers who received the tailored intervention had 85% lower odds of demonstrating a treatment bias against black patients and 76% lower odds of demonstrating a treatment bias against low SES patients at follow-up. Providers who received the intervention for racial bias also showed increased compassion for patients compared with providers in the control condition. Group differences did not emerge for provider comfort in treating patients. Results suggest an online intervention that is tailored to providers according to their individual treatment biases, delivers feedback about these biases, and provides opportunities for increased contact with black and low SES patients, can produce substantial changes in providers' treatment decisions, resulting in more equitable pain care. Future studies should examine how these effects translate to real-world patient care and the optimal timing/dose of the intervention.",2019,"Compared with the control group, providers who received the tailored intervention had 85% lower odds of demonstrating a treatment bias against black patients and 76% lower odds of demonstrating a treatment bias against low SES patients at follow-up.","[""providers' pain treatment decisions"", 'virtual patients with chronic pain who varied by race (black/white) and SES (low/high', 'pain care', 'Physician residents and fellows (n = 436) were recruited from across the United States for this two-part online study']","['virtual perspective-taking intervention', 'personalized feedback about their bias, real-time dynamic interactions with virtual patients, and videos depicting how pain impacts']","['provider comfort', 'compassion']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}]",436.0,0.0435293,"Compared with the control group, providers who received the tailored intervention had 85% lower odds of demonstrating a treatment bias against black patients and 76% lower odds of demonstrating a treatment bias against low SES patients at follow-up.","[{'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Hollingshead', 'Affiliation': 'Department of Family Medicine, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Anastas', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Carnell', 'Affiliation': 'Department of Computer and Information Science and Engineering, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Lok', 'Affiliation': 'Department of Computer and Information Science and Engineering, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Chu', 'Affiliation': 'Department of Biostatistics, Indiana University Fairbanks School of Public Health and School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Indiana University Fairbanks School of Public Health and School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA Health Services Research and Development Center for Excellence on Implementing Evidence-Based Practice, Roudebush VA Medical Center, Indianapolis, IN, United States.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ashburn-Nardo', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Pain,['10.1097/j.pain.0000000000001634']
543,31984422,The impact of long-term biologics/target therapy on bone mineral density in rheumatoid arthritis: a propensity score-matched analysis.,"OBJECTIVES


To investigate changes in BMD in RA patients receiving 3-year biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or conventional synthetic DMARD (csDMARD).
METHODS


Patients with RA were recruited from September 2014 until March 2019. Clinical characteristics, BMD and evidence of fragility fractures at enrolment were documented. Participants were treated according to the National Institute for Health and Care Excellence (NICE) guidelines over a 3-year observation period. Repeated BMD was measured at the end of the study period. Participants were grouped into those receiving b/tsDMARD or csDMARD and by propensity score matching (1:2).
RESULTS


A total of 388 participants completed the 3-year follow-up. After propensity score matching, 92 and 184 participants were allocated to the b/tsDMARD (Group I) and csDMARD (Group II), respectively. After 3 years, BMD remained stable at the femoral neck (FN), hip (total) (TH) and lumbar vertebra (L1-4) (P =0.09, 0.15, 0.87) in Group I. However, BMD decreased significantly in Group II (P=0.045, <0.001, 0.004) at corresponding sites. Participants receiving combined b/tsDMARD and anti-osteoporosis therapy experienced a greater BMD preserving effect than other subgroups.
CONCLUSION


Long-term b/tsDMARDs therapy had protective effects on bone loss for patients with RA. Patients receiving concomitant anti-osteoporosis therapy and b/tsDMARDs therapy experienced the greatest BMD preserving effect.",2020,"However, BMD decreased significantly in Group II (P=0.045, <0.001, 0.004) at corresponding sites.","['Participants receiving', 'rheumatoid arthritis', 'RA patients receiving 3-year biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or conventional synthetic DMARD (csDMARD', 'patients with RA', '388 participants completed the 3-year follow-up', 'Participants were treated according to the National Institute for Health and Care Excellence (NICE) guidelines over a 3-year observation period', 'Participants were grouped into those receiving b/tsDMARD or csDMARD and by propensity score matching (1:2', 'Patients receiving', 'Patients with RA were recruited from September 2014 until March 2019']","['combined b/tsDMARD and anti-osteoporosis therapy', 'concomitant anti-osteoporosis therapy and b/tsDMARDs therapy']","['Repeated BMD', 'BMD remained stable at the femoral neck (FN), hip (total) (TH) and lumbar vertebra', 'BMD', 'BMD preserving effect', 'bone loss', 'bone mineral density']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0024091', 'cui_str': 'Lumbar Vertebrae'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",388.0,0.0292208,"However, BMD decreased significantly in Group II (P=0.045, <0.001, 0.004) at corresponding sites.","[{'ForeName': 'Jia-Feng', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Chung-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Shan-Fu', 'Initials': 'SF', 'LastName': 'Yu', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Chi-Hua', 'Initials': 'CH', 'LastName': 'Ko', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Chan', 'Initials': 'WC', 'LastName': 'Chiu', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Han-Ming', 'Initials': 'HM', 'LastName': 'Lai', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Ying-Chou', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Yu-Jih', 'Initials': 'YJ', 'LastName': 'Su', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}, {'ForeName': 'Tien-Tsai', 'Initials': 'TT', 'LastName': 'Cheng', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez655']
544,31970313,Frozen embryo transfer: Endometrial preparation by letrozole versus hormone replacement cycle: A randomized clinical trial.,"Background


The endometrial preparation with stimulating natural cycles for frozen embryo transfer (FET) have benefits like lower cost and ease of use.
Objective


Comparing the clinical outcome of letrozole versus hormone replacement (HR) for endometrial preparation in women with normal menstrual cycles for FET in artificial reproduction techniques.
Materials and Methods


A total of 167 participants who had frozen embryos and regular ovulatory cycles were randomly divided into two groups for endometrial preparation. One group (82 women) was stimulated with letrozole 5mg/day and the other group (85 women) was hormonally stimulated by oral estradiol valerate (2 mg three times a day). All participants were followed serially by ultrasonography. Any patient who did not reach optimal endometrial thickness was excluded from the study. Implantation, biochemical and clinical pregnancy and abortion rate were reported.
Results


There was no significant difference in the mean age, duration, and primary or secondary infertility, cause of the infertility, number, and quality of transferred embryos between the groups. The mean estradiol level on the day of transfer was 643  ±  217 in the HR group and 547  ±  212 in the letrozole group (P = 0.01), which was significantly different. The clinical pregnancy rate was 38.7 in the letrozole group, higher than the HR group (25.3) but not significantly different (P = 0.06).
Conclusion


For endometrial preparation in women with a normal cycle, letrozole yields higher pregnancy rate although it is not significant; due to its cost, ease in use, and lower side effects, letrozole is a good choice.",2019,"There was no significant difference in the mean age, duration, and primary or secondary infertility, cause of the infertility, number, and quality of transferred embryos between the groups.","['women with normal menstrual cycles for FET in artificial reproduction techniques', 'women with a normal cycle', '167 participants who had frozen embryos and regular ovulatory cycles']","['letrozole versus hormone replacement (HR', 'letrozole', 'frozen embryo transfer (FET', 'oral estradiol valerate']","['Implantation, biochemical and clinical pregnancy and abortion rate', 'mean age, duration, and primary or secondary infertility, cause of the infertility, number, and quality of transferred embryos', 'clinical pregnancy rate', 'mean estradiol level']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0035151', 'cui_str': 'Reproduction Techniques'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0059623', 'cui_str': 'estradiol valerate'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0269230', 'cui_str': 'Secondary female infertility (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",167.0,0.0616313,"There was no significant difference in the mean age, duration, and primary or secondary infertility, cause of the infertility, number, and quality of transferred embryos between the groups.","[{'ForeName': 'Alamtaj', 'Initials': 'A', 'LastName': 'Samsami', 'Affiliation': 'Infertility Research Center, Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ghasmpour', 'Affiliation': 'Infertility Research Center, Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Davoodi', 'Affiliation': 'Infertility Research Center, Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Moradi Alamdarloo', 'Affiliation': 'Infertility Research Center, Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Rahmati', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Karimian', 'Affiliation': 'Department of Physiology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamide', 'Initials': 'H', 'LastName': 'Homayoon', 'Affiliation': 'Infertility Research Center, Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i12.5793']
545,31970315,School girls and childbearing motives: A randomized clinical trial through hidden curriculum.,"Background


Childbearing motives are considered as the primary stimulus of fertility and the importance of making fertility decisions in humans.
Objective


The aim of this study is to determine the effect of a new form of interactional program on the childbearing motives of students.
Materials and Methods


According to a well-defined, single-blind randomized controlled trial, we selected eight government schools in Tehran. Students in the age range of 7-12 yr and 16-18 yr (130 students in each school with a total number of 260) were selected for a series of intervention from storytelling to free discussion on a special subject through the concept of hidden curriculum. We evaluate the outcome with pretest-posttest based on the Miller childbearing motives questionnaire. One month after the last intervention, final evaluation took place.
Results


The findings showed that after an intervention conducted in the best way, all positive scores were promoted while the negative ones declined. One the other hand, no matter what really the participant's groups were, their total intention score got better. In this way, the total positive scores were significantly increased in the intervention groups (p = 0.000) Also, the students in high school significantly improved in positive scores and the negative score decreased in them.
Conclusion


This study showed that the fundamental childbearing motives even with small interventions can be improved. Our intervention could improve the positive childbearing motives among school girls. In this regard, the role of some confounding factor such as the role of some confounding factors such as religious beliefs in family, maternal education is most important.",2019,"In this way, the total positive scores were significantly increased in the intervention groups (p = 0.000) Also, the students in high school significantly improved in positive scores and the negative score decreased in them.
","['Students in the age range of 7-12 yr and 16-18 yr (130 students in each school with a total number of 260', 'childbearing motives of students', 'School girls and childbearing motives', 'selected eight government schools in Tehran']",['interactional program'],"['total positive scores', 'positive scores and the negative score', 'positive childbearing motives']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",260.0,0.0250693,"In this way, the total positive scores were significantly increased in the intervention groups (p = 0.000) Also, the students in high school significantly improved in positive scores and the negative score decreased in them.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Oshrieh', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Keramat', 'Affiliation': ""Reproductive Studies and Women's Health Research Center, Shahroud University of Medical Sciences, Shahroud, Iran.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shariati', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Tehranian', 'Affiliation': 'Department of Reproductive Health and Midwifery, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Effatpanah', 'Affiliation': 'Department of Psychiatry, Ziaeian Hospital, School of Medicine, Tehran University of Medical Science, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i12.5805']
546,31506338,Targeted Lung Deposition From Nebulization Is Not Improved in the Lateral Decubitus Position in Healthy Volunteers.,"BACKGROUND


Clinical benefits of inhaled therapies are related to the amount of drug deposited in the targeted area of the lung. Body positions that influence the distribution of lung ventilation should impact lung deposition of the nebulized drug. The aim of this study was to analyze the immediate effect of body position while the subject lies on his side (lateral decubitus) during nebulization on 3-dimensional total and regional lung deposition.
METHODS


A randomized crossover trial was performed on healthy male volunteers without cardiovascular or pulmonary disease. A technetium-99m diethylenetriaminepentaacetic acid ( 99m Tc-DTPA) solution (4 mL) was nebulized using an individual-controlled inhalation system in left lateral decubitus and sitting positions with a 96-h washout period (43 inspirations of 4 s [ie, drug delivered until second 3] with a tidal volume of 0.8 L and a low inspiratory flow (200 mL/s). Drug deposition was followed with the use of planar images and single-photon-emission computed tomography combined with low-resolution computed tomography. Total and regional depositions were the main outcomes. Penetration index was also considered.
RESULTS


Six participants (26.8 ± 6.9 y old) were included. Total lung deposition tended to be higher in a sitting position than in a lateral decubitus position: 10.2 ± 0.9% of nominal dose (95% CI 9.1-11.3) vs 8.6 ± 1.4% of nominal dose (95% CI 6.8-10.4) ( P  = .09). The deposition was significantly reduced in the dependent (left) lung in the lateral decubitus position: 3.5 ± 0.7% of nominal dose (95% CI 2.6-4.3) vs 4.7 ± 0.3% of nominal dose (95% CI 4.3-5.0) ( P  = .03). Penetration index was only influenced by body position for the dependent (left) lung ( P  = .043).
CONCLUSIONS


The total amount of drug delivered to the lungs during nebulization with an individual-controlled inhalation system tended to decrease when performed in the left lateral decubitus position. Moreover, contrary to the initial hypothesis, the deposition of particles in the dependent lung was not improved by the lateral decubitus position in this configuration. (ClinicalTrials.gov registration NCT02451501.).",2019,Total lung deposition tended to be higher in a sitting position than in a lateral decubitus position: 10.2 ± 0.9% of nominal dose (95% CI 9.1-11.3) vs 8.6 ± 1.4% of nominal dose (95% CI 6.8-10.4) ( P  = .09).,"['Healthy Volunteers', 'healthy male volunteers without cardiovascular or pulmonary disease', 'Six participants (26.8 ± 6.9 y old) were included']","['planar images and single-photon-emission computed tomography combined with low-resolution computed tomography', 'technetium-99m diethylenetriaminepentaacetic acid ( 99m Tc-DTPA) solution']","['Penetration index', 'Total and regional depositions', 'Total lung deposition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0303611', 'cui_str': 'Technetium 99m'}, {'cui': 'C0013254', 'cui_str': 'Pentetic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]",6.0,0.0569859,Total lung deposition tended to be higher in a sitting position than in a lateral decubitus position: 10.2 ± 0.9% of nominal dose (95% CI 9.1-11.3) vs 8.6 ± 1.4% of nominal dose (95% CI 6.8-10.4) ( P  = .09).,"[{'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Groupe de Recherche en Kinésithérapie Respiratoire, Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Brussels, Belgium. gregory.reychler@uclouvain.be.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Miguel-Pagola', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Groupe de Recherche en Kinésithérapie Respiratoire, Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Aubriot', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Groupe de Recherche en Kinésithérapie Respiratoire, Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Herrero-Cortina', 'Affiliation': 'Universidad San Jorge, Campus Universitario Villanueva de Gállego, Zaragoza, Spain.'}, {'ForeName': 'Vinciane', 'Initials': 'V', 'LastName': 'Lecocq', 'Affiliation': 'Service de Pneumologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hesse', 'Affiliation': 'Service de Médecine Nucléaire, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Liistro', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Groupe de Recherche en Kinésithérapie Respiratoire, Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jamar', 'Affiliation': 'Service de Médecine Nucléaire, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}]",Respiratory care,['10.4187/respcare.06978']
547,31961936,Effect of 2 Enteral Feeding Schedules on Intra-abdominal Pressure in Patients Receiving Mechanical Ventilation: A Randomized Controlled Trial.,"BACKGROUND


Elevated intra-abdominal pressure is associated with morbidity in critically ill patients. Enteral feeding is important for these patients but may cause complications.
OBJECTIVE


To compare the effects of 2 intermittent feeding schedules on intra-abdominal pressure in patients receiving mechanical ventilation.
METHODS


A single-blinded, prospective, parallel-group, randomized controlled trial was conducted in an intensive care unit in a teaching hospital in Egypt. Fifty adult patients requiring more than 48 hours of mechanical ventilation were enrolled. Patients were randomly sorted into 2 study groups. The intervention group received intermittent enteral feedings 5 times daily at 4-hour intervals. The control group received intermittent enteral feedings 10 times daily at 2-hour intervals. Both groups fasted for 8 hours overnight. Intra-abdominal pressure was measured 7 times: at admission and before and after the first 3 feedings on the third day of the intensive care unit stay.
RESULTS


One-way repeated-measures analysis of variance showed that mean intra-abdominal pressure was higher in the control group before the first feeding (t = 2.27, P = .03) but was higher in the intervention group after the second feeding (t = 2.51, P = .02) and after the third feeding (t = 2.41, P = .02). Vomiting and diarrhea were not significantly different between the groups. More constipation and abdominal distension occurred in the intervention group than in the control group.
CONCLUSION


Intra-abdominal pressure was not significantly affected by feeding interval. However, reducing the time interval between intermittent enteral feedings may minimize the risk for constipation and abdominal distension.",2019,"RESULTS


One-way repeated-measures analysis of variance showed that mean intra-abdominal pressure was higher in the control group before the first feeding (t = 2.27, P = .03) but was higher in the intervention group after the second feeding (t = 2.51, P = .02) and after the third feeding (t = 2.41, P = .02).","['patients receiving mechanical ventilation', 'intensive care unit in a teaching hospital in Egypt', 'Fifty adult patients requiring more than 48 hours of mechanical ventilation were enrolled', 'Patients Receiving Mechanical Ventilation', 'critically ill patients']",['intermittent enteral feedings'],"['Intra-abdominal pressure', 'mean intra-abdominal pressure', 'Intra-abdominal Pressure', 'constipation and abdominal distension', 'Vomiting and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",50.0,0.111978,"RESULTS


One-way repeated-measures analysis of variance showed that mean intra-abdominal pressure was higher in the control group before the first feeding (t = 2.27, P = .03) but was higher in the intervention group after the second feeding (t = 2.51, P = .02) and after the third feeding (t = 2.41, P = .02).","[{'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Mahran', 'Affiliation': 'Ghada Mahran and Asmaa Mahgoup are lecturers in the Department of Critical Care Nursing, Faculty of Nursing, Assiut University, Asyut, Egypt. Emad Zarief Kamel is an associate professor in the Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University. Muayyad M. Ahmad is a professor in the Clinical Nursing Department, School of Nursing, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Asmaa', 'Initials': 'A', 'LastName': 'Mahgoup', 'Affiliation': 'Ghada Mahran and Asmaa Mahgoup are lecturers in the Department of Critical Care Nursing, Faculty of Nursing, Assiut University, Asyut, Egypt. Emad Zarief Kamel is an associate professor in the Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University. Muayyad M. Ahmad is a professor in the Clinical Nursing Department, School of Nursing, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Emad Zarief', 'Initials': 'EZ', 'LastName': 'Kamel', 'Affiliation': 'Ghada Mahran and Asmaa Mahgoup are lecturers in the Department of Critical Care Nursing, Faculty of Nursing, Assiut University, Asyut, Egypt. Emad Zarief Kamel is an associate professor in the Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University. Muayyad M. Ahmad is a professor in the Clinical Nursing Department, School of Nursing, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Muayyad M', 'Initials': 'MM', 'LastName': 'Ahmad', 'Affiliation': 'Ghada Mahran and Asmaa Mahgoup are lecturers in the Department of Critical Care Nursing, Faculty of Nursing, Assiut University, Asyut, Egypt. Emad Zarief Kamel is an associate professor in the Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University. Muayyad M. Ahmad is a professor in the Clinical Nursing Department, School of Nursing, University of Jordan, Amman, Jordan.'}]",Critical care nurse,['10.4037/ccn2019967']
548,31770446,Efficacy of Adductor Canal Block With Liposomal Bupivacaine: A Randomized Prospective Clinical Trial.,"This study compared the postoperative analgesic efficacy of liposomal bupivacaine as a single-administration adductor canal block (ACB) vs periarticular injection (PAI) for pain control after total knee arthroplasty (TKA). From May 2016 to June 2017, a total of 70 unilateral TKA patients were randomized into 2 groups: PAI (extended-release bupivacaine 266 mg [20-mL vial] with 20 mL of 0.5% bupivacaine hydrochloride and normal saline to a total volume of 120 mL) and ACB (subsartorial saphenous nerve using extended-release bupivacaine 266 mg [20-mL vial]). All patents underwent spinal anesthesia with comprehensive preemptive and postoperative multi-modal pain protocol. All opioids administered were converted to morphine equivalents. Pain was recorded at 4 to 12 hours on the day of surgery, and on postoperative days 1, 2, and 3. Patients and investigators other than the surgeon and anesthesiologist were blinded to the study. The difference in pain scores between the PAI and ACB groups was not statistically significant during the first 12 hours (day 0) after surgery or on postoperative day 1 (5.31 vs 4.26, P=.091). However, on postoperative day 3, the mean pain score increased in the ACB group and decreased in the PAI group (4.8 vs 1.83, P=.037). There was no statistically significant difference between the 2 groups regarding the accumulative daily converted morphine equivalent consumption or total consumption. Although the PAI group demonstrated longer lasting pain relief than the ACB group for the duration of the study, other outcomes were similar between the 2 groups. [Orthopedics. 2020; 43(1):e47-e53.].",2020,"However, on postoperative day 3, the mean pain score increased in the ACB group and decreased in the PAI group (4.8 vs 1.83, P=.037).","['From May 2016 to June 2017, a total of 70 unilateral TKA patients', 'pain control after total knee arthroplasty (TKA']","['liposomal bupivacaine', 'ACB', 'PAI (extended-release bupivacaine 266 mg [20-mL vial] with 20 mL of 0.5% bupivacaine hydrochloride and normal saline to a total volume of 120 mL) and ACB (subsartorial saphenous nerve using extended-release bupivacaine 266 mg [20-mL vial', 'adductor canal block (ACB) vs periarticular injection (PAI', 'Adductor Canal Block With Liposomal Bupivacaine', 'spinal anesthesia with comprehensive preemptive and postoperative multi-modal pain protocol']","['pain scores', 'lasting pain relief', 'Pain', 'mean pain score', 'postoperative analgesic efficacy', 'accumulative daily converted morphine equivalent consumption or total consumption']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1706398', 'cui_str': 'Vil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0228919', 'cui_str': 'Structure of saphenous nerve'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394854', 'cui_str': 'Periarticular injection (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",70.0,0.100739,"However, on postoperative day 3, the mean pain score increased in the ACB group and decreased in the PAI group (4.8 vs 1.83, P=.037).","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Meftah', 'Affiliation': ''}, {'ForeName': 'Suhas', 'Initials': 'S', 'LastName': 'Boenerjous-Abel', 'Affiliation': ''}, {'ForeName': 'Vinay H', 'Initials': 'VH', 'LastName': 'Siddappa', 'Affiliation': ''}, {'ForeName': 'Ira H', 'Initials': 'IH', 'LastName': 'Kirschenbaum', 'Affiliation': ''}]",Orthopedics,['10.3928/01477447-20191122-05']
549,31560736,"Assessment of Somatosensory Function, Pain, and Unpleasantness in Two Surrogate Models of Trigeminal Nerve Damage: A Randomized, Double-Blind, Controlled Crossover Study.","AIMS


To assess the pain and/or unpleasantness and the somatosensory changes caused by two experimental models of trigeminal nerve damage (topical application of capsaicin and local anesthetics) in healthy participants using extensive evaluation tools.
METHODS


This double-blinded, randomized, placebo-controlled, crossover study included 20 healthy adult participants who underwent three separate sessions of testing. In each session, the psychophysical quantitative sensory testing (QST) and the electrophysiologic electrically evoked trigeminal ""nociceptive-specific"" blink reflex (nBR) investigations were performed at baseline. Following a 15-minute topical application of 0.1% capsaicin, 5% EMLA, or Vaseline (placebo) agents, the maximum numeric rating scale pain and unpleasantness scores were recorded. Additionally, qualitative sensory testing and somatosensory mapping were performed. The QST and nBR investigations were repeated immediately after each application. Data were analyzed using repeated-measures analysis of variance.
RESULTS


Capsaicin application was associated with significantly higher pain and unpleasantness scores when compared to EMLA and Vaseline (P < .001), with varied bidirectional somatosensory changes among the participants and significant loss of thermosensory function (P < .030). EMLA application induced loss of thermal and mechanical somatosensory function (P < .030) and a significant reduction in electrically evoked pain scores on nBR investigation (P < .001). No significant changes were seen in the electrophysiologic component of the nBR after any of the applications (P = .922).
CONCLUSION


Topical capsaicin and EMLA application mimicked certain aspects of somatosensory changes seen in trigeminal nerve damage patients and may be used as surrogate models of such changes.",2020,EMLA application induced loss of thermal and mechanical somatosensory function (P < .030) and a significant reduction in electrically evoked pain scores on nBR investigation (P < .001).,"['20 healthy adult participants who underwent three separate sessions of testing', 'healthy participants using extensive evaluation tools', 'trigeminal nerve damage patients']","['capsaicin and local anesthetics', 'placebo', 'psychophysical quantitative sensory testing (QST) and the electrophysiologic electrically evoked trigeminal ""nociceptive-specific"" blink reflex (nBR', 'EMLA and Vaseline', 'capsaicin, 5% EMLA, or Vaseline (placebo', 'Topical capsaicin and EMLA', 'EMLA']","['electrically evoked pain scores', 'electrophysiologic component of the nBR', 'loss of thermal and mechanical somatosensory function', 'pain and/or unpleasantness', 'pain and unpleasantness scores', 'maximum numeric rating scale pain and unpleasantness scores', 'thermosensory function', 'Somatosensory Function, Pain, and Unpleasantness']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0040996', 'cui_str': 'Cranial Nerve V'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0596003', 'cui_str': 'Blink Reflexes'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",20.0,0.327261,EMLA application induced loss of thermal and mechanical somatosensory function (P < .030) and a significant reduction in electrically evoked pain scores on nBR investigation (P < .001).,"[{'ForeName': 'Rajath Sasidharan', 'Initials': 'RS', 'LastName': 'Pillai', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pigg', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'List', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': ''}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baad-Hansen', 'Affiliation': ''}]",Journal of oral & facial pain and headache,['10.11607/ofph.2423']
550,31896491,"Fluoxetine for motor recovery after acute intracerebral hemorrhage, the FMRICH trial.","OBJECTIVES


Acute intracerebral hemorrhage (ICH) is a very common cause of disability. Previous evidence suggests that fluoxetine and other selective serotonin reuptake inhibitors improve, the recovery of motor function in patients with cerebral infarct. The purpose of this study was to investigate whether fluoxetine also improves motor recovery in patients with ICH.
PATIENTS AND METHODS


This is a double blind, placebo controlled, multicenter randomized trial, patients recruited from three centers were assigned to receive 20 mg/day of fluoxetine or matching placebo for three months from within ten days after onset of symptoms. Primary outcome was change in Fugl-Meyer Motor Scale from baseline to day 90.
RESULTS


Thirty patients (50 % women) were recruited to the fluoxetine (n = 14) or placebo (n = 16) groups. Median age was 55 years, the cause of the ICH was hypertension in 93.3 %, median volume of the hematomas was 22mm 3 . Basal ganglia hematoma was present in 67 % and, lobar location in 20 % of the patients. Improvement in FMMS at day 90 was significatively higher in the treatment group (median score 23) than in the placebo group, (median score 48), p = 0.001. No serious adverse events occurred.
CONCLUSION


In addition to standard treatment, early prescription of fluoxetine was safe and helped to increase motor recovery 90 days after ICH. This finding adds to the evidence regarding its beneficial effect upon stroke related disability. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737541.",2020,"Improvement in FMMS at day 90 was significatively higher in the treatment group (median score 23) than in the placebo group, (median score 48), p = 0.001.","['Thirty patients (50 % women', 'Acute intracerebral hemorrhage (ICH', 'patients with ICH', 'patients recruited from three centers', 'patients with cerebral infarct']","['placebo', 'fluoxetine or matching placebo', 'fluoxetine', 'Fluoxetine']","['change in Fugl-Meyer Motor Scale', 'FMMS', 'motor recovery', 'recovery of motor function', 'Basal ganglia hematoma']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",30.0,0.468022,"Improvement in FMMS at day 90 was significatively higher in the treatment group (median score 23) than in the placebo group, (median score 48), p = 0.001.","[{'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Marquez-Romero', 'Affiliation': 'Instituto Mexicano Del Seguro Social (IMSS) HGZ 2. Aguascalientes, México Av. De Los Conos 102, Fraccionamiento Ojo Caliente, Desarrollo Especial Ojocaliente, Aguascalientes, 20190, Mexico. Electronic address: scint1st@gmail.com.'}, {'ForeName': 'Maricela', 'Initials': 'M', 'LastName': 'Reyes-Martínez', 'Affiliation': 'Hospital De Alta Especialidad ""Dr. Juan Graham Casasus"", Calle Uno S/N, Miguel Hidalgo III Etapa, 86126, Villahermosa, Tabasco, México.'}, {'ForeName': 'María Raquel', 'Initials': 'MR', 'LastName': 'Huerta-Franco', 'Affiliation': 'Department of Applied Sciences to Work, Health Science Division, University of Guanajuato, Av. Eugenio Garza Sada #572, Lomas Del Campestre Sección II, C.P. 37150, León, Guanajuato, Mexico.'}, {'ForeName': 'Angélica', 'Initials': 'A', 'LastName': 'Ruiz-Franco', 'Affiliation': 'Stroke Clinic Instituto Nacional De Neurología y Neurocirugía ""MVS"", Av. Insurgentes Sur 3877, La Fama, 14269, Mexico City, Mexico.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Silos', 'Affiliation': 'Stroke Clinic Instituto Nacional De Neurología y Neurocirugía ""MVS"", Av. Insurgentes Sur 3877, La Fama, 14269, Mexico City, Mexico.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arauz', 'Affiliation': 'Stroke Clinic Instituto Nacional De Neurología y Neurocirugía ""MVS"", Av. Insurgentes Sur 3877, La Fama, 14269, Mexico City, Mexico.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2019.105656']
551,31955940,Ultralong Versus Standard Long Peripheral Intravenous Catheters: A Randomized Controlled Trial of Ultrasonographically Guided Catheter Survival.,"STUDY OBJECTIVE


Ultrasonographically guided intravenous peripheral catheters have dismal dwell time, with most intravenous lines failing before completion of therapy. Catheter length in the vein is directly related to catheter longevity. We investigate the survival of an ultralong ultrasonographically guided intravenous peripheral catheter compared with a standard long one.
METHODS


We conducted a single-site, nonblinded, randomized trial of catheter survival. Adult patients presenting to the emergency department with difficult vascular access were recruited and randomized to receive either standard long, 4.78-cm, 20-gauge ultrasonographically guided intravenous peripheral catheters or ultralong, 6.35-cm, 20-gauge ultrasonographically guided intravenous peripheral catheters. The primary outcome was duration of catheter survival. The secondary outcome was the optimal length of the catheter in the vein to maximize survival. Additional intravenous-related endpoints included first-stick success, time to insertion, number of attempts, thrombosis, and infection.
RESULTS


Between October 2018 and March 2019, 257 patients were randomized, with 126 in the standard long ultrasonographically guided intravenous peripheral catheter group and 131 in the ultralong group. Kaplan-Meier estimate of catheter median survival time in the ultralong group was 136 hours (95% confidence interval [CI] 116 to 311 hours) compared with 92 hours (95% CI 71 to 120 hours) in the standard long group, for a difference of 44 hours (95% CI 2 to 218 hours). The optimal catheter length in the vein was 2.75 cm, and intravenous lines with greater than 2.75 cm inserted had a median survival of 129 hours (95% CI 102 to 202 hours) compared with 75 hours (95% CI 52 to 116 hours) for intravenous lines with less than or equal to 2.75 cm, for a difference of 54 hours (95% CI 10 to 134 hours). Insertion characteristics were similar between the groups: 74.1% versus 79.4% first-stick success (95% CI for the difference -2% to 5%), 1.4 versus 1.3 for number of attempts (95% CI for the difference -0.1 to 0.3), and 6.9 versus 5.9 minutes to completion (95% CI for the difference -1.3 to 3.4) with ultralong versus standard long, respectively. There were no cases of infection or thrombosis.
CONCLUSION


This study demonstrated increased catheter survival when the ultralong compared with the standard long ultrasonographically guided intravenous peripheral catheter was used, whereas insertion characteristics and safety appeared similar.",2020,"This study demonstrated increased catheter survival when the ultralong compared with the standard long ultrasonographically guided intravenous peripheral catheter was used, whereas insertion characteristics and safety appeared similar.","['Adult patients presenting to the emergency department with difficult vascular access', '257 patients were randomized, with 126 in the', 'Between October 2018 and March 2019']","['Ultrasonographically Guided Catheter Survival', '20-gauge ultrasonographically guided intravenous peripheral catheters or ultralong, 6.35-cm, 20-gauge ultrasonographically guided intravenous peripheral catheters', 'Ultralong Versus Standard Long Peripheral Intravenous Catheters', 'standard long ultrasonographically guided intravenous peripheral catheter']","['optimal catheter length', 'Catheter length', 'stick success, time to insertion, number of attempts, thrombosis, and infection', 'optimal length of the catheter in the vein to maximize survival', 'median survival', 'infection or thrombosis', 'catheter median survival time', 'duration of catheter survival', 'Insertion characteristics', 'catheter survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0221799', 'cui_str': 'Guiding catheter, device (physical object)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1827740', 'cui_str': 'Peripheral catheter (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",257.0,0.261121,"This study demonstrated increased catheter survival when the ultralong compared with the standard long ultrasonographically guided intravenous peripheral catheter was used, whereas insertion characteristics and safety appeared similar.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI. Electronic address: amit.bahl@beaumont.edu.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Hijazi', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Nai-Wei', 'Initials': 'NW', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lachapelle-Clavette', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Price', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.11.013']
552,30706788,"Impact of Ondansetron on Withdrawal Signs, Fentanyl Requirement and Pain Relief in Opioid-addicted Patients under General Anesthesia.","BACKGROUND


Serotonin 5-HT3 receptor antagonists such as ondansetron have been investigated to attenuate opioid withdrawal signs in studies.
OBJECTIVE


Therefore, we designed a randomized double-blinded placebo-controlled trial to evaluate this effect on opioid-addicted patients who were admitted to the orthopedic department for surgery due to bone fractures.
METHODS


Male adults who were addicted to opioids, aged 18 to 79 years were enrolled (n=96) and randomized into intravenous doses (4 & 8 mg) of ondansetron (n=32) and placebo (n=32). The vital signs, withdrawal symptoms and the frequency requirement of fentanyl were recorded during anesthesia, and opioid (pethidine) analgesic was received during the recovery period. Outcome parameters were analyzed for reduction of withdrawal symptoms in addicted adults.
RESULTS


We indicated that ondansetron demonstrated significant differences with few vital outcomes including systolic blood pressure (SBP) 20 (SBP3) and 50 min (SBP4) after injection of ondansetron during the period of surgery. Ondansetron could also significantly reduce the frequency requirement of fentanyl at 20 min (dose 3) in general anesthesia. Furthermore, requirement for further administration of opioid analgesic drugs such as pethidine was significantly reduced in the ondansetron groups. Objective opioid withdrawal scale (OOWS) results indicated that few clinical parameters including tremor, hot and cold flushes and anxiety were significantly attenuated in addicted patients who received ondansetron.
CONCLUSION


This study demonstrated supporting evidence for the beneficial treatment of ondansetron for the control of withdrawal symptoms and pain in addicted patients, and more clinical studies are suggested in this regard.",2019,Ondansetron could also significantly reduce the frequency requirement of fentanyl at 20 min (Dose 3) in general anesthesia.,"['Male adults who were addicted to opioids, aged 18 to 79 years were enrolled (n=96', 'opioid-addicted patients who were admitted to orthopedic department for surgery due to bone fractures', 'adult addicted patients', 'addicted patients', 'opioid addicted patients under general anesthesia']","['Ondansetron', 'ondansetron', 'placebo']","['Objective opioid withdrawal scale (OOWS', 'frequency requirement of fentanyl', 'withdrawal symptoms', 'withdrawal signs, fentanyl requirement and pain relief', 'vital signs and withdrawal symptoms and the frequency requirement of fentanyl', 'tremor, hot and cold flushes and anxiety', 'systolic blood pressure (BPS) 20 (BPS 3) and 50 min (BPS 4']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C4304523', 'cui_str': 'Withdrawal sign'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0518766'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",,0.242422,Ondansetron could also significantly reduce the frequency requirement of fentanyl at 20 min (Dose 3) in general anesthesia.,"[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Mahikhan', 'Affiliation': 'Department of Toxicology and Pharmacology, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Hashemian', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Dehesh', 'Affiliation': 'Department of Epidemiology, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Jafari', 'Affiliation': 'Pathology and Stem Cells Research Center, Kerman University of Medical Science, Kerman, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Hamid-Reza', 'Initials': 'HR', 'LastName': 'Rahimi', 'Affiliation': 'Department of Toxicology and Pharmacology, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}]",Current clinical pharmacology,['10.2174/1574884714666190131122846']
553,31780337,A randomized controlled trial comparing subscapularis tenotomy with peel in anatomic shoulder arthroplasty.,"BACKGROUND


Controversy exists regarding the optimal technique of subscapularis tendon mobilization during anatomic shoulder arthroplasty. The purpose of this prospective, randomized, double-blind study was to compare internal rotation strength in the belly-press position and functional outcomes between the subscapularis tenotomy and subscapularis peel approaches during shoulder arthroplasty.
METHODS


Patients undergoing anatomic shoulder arthroplasty were randomized to either a tenotomy or peel approach. The primary outcome was internal rotation strength in the belly-press position, measured by an electronic handheld dynamometer at 24 months postoperatively. Secondary outcomes included the Western Ontario Osteoarthritis of the Shoulder (WOOS) index score, American Shoulder and Elbow Surgeons (ASES) score, range of motion, radiographic lucencies, and adverse events.
RESULTS


We randomized 100 patients to subscapularis tenotomy (n = 47) or peel (n = 53). Eighty-one percent of the cohort returned for 24 months' follow-up. Compared with baseline measures, mean internal rotation strength in the belly-press position and WOOS and ASES scores improved in both groups at final follow-up (P < .0001). Intention-to-treat analysis for internal rotation strength at 24 months revealed no significant difference (P = .57) between tenotomy (mean, 4.9 kg; SD, 3.8 kg) and peel (mean, 5.4 kg; SD, 3.9 kg). Comparison of WOOS and ASES scores demonstrated no significant differences between groups at any time point. The healing rates by ultrasound were 72% for tenotomy and 71% for peel (P = .99).
DISCUSSION


No statistically significant difference in internal rotation strength was identified between the tenotomy and peel groups. The secondary outcomes were not significantly different between groups.",2020,"The healing rates by ultrasound were 72% for tenotomy and 71% for peel (P = .99).
","['anatomic shoulder arthroplasty', '100 patients to subscapularis tenotomy (n = 47) or peel (n = 53', 'Patients undergoing anatomic shoulder arthroplasty']","['tenotomy or peel approach', 'subscapularis tenotomy and subscapularis peel approaches', 'subscapularis tenotomy with peel']","['WOOS and ASES scores', 'internal rotation strength in the belly-press position, measured by an electronic handheld dynamometer', 'mean internal rotation strength in the belly-press position and WOOS and ASES scores', 'internal rotation strength', 'healing rates', 'Western Ontario Osteoarthritis of the Shoulder (WOOS) index score, American Shoulder and Elbow Surgeons (ASES) score, range of motion, radiographic lucencies, and adverse events']","[{'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0584884', 'cui_str': 'Subscapularis'}, {'cui': 'C0856438', 'cui_str': 'Tenotomy (psoas)'}]","[{'cui': 'C0856438', 'cui_str': 'Tenotomy (psoas)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0584884', 'cui_str': 'Subscapularis'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.147169,"The healing rates by ultrasound were 72% for tenotomy and 71% for peel (P = .99).
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lapner', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, ON, Canada; Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. Electronic address: plapner@toh.ca.'}, {'ForeName': 'J Whitcomb', 'Initials': 'JW', 'LastName': 'Pollock', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, ON, Canada; Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Tinghua', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ruggiero', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, ON, Canada.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Momoli', 'Affiliation': ""Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.""}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Department of Medical Imaging, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Athwal', 'Affiliation': ""Roth|McFarlane Hand and Upper Limb Centre, St. Joseph's Health Care London, London, ON, Canada; University of Western Ontario, London, ON, Canada.""}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.09.028']
554,31132133,Efficacy of a new parent and school-supported intervention after moderate and severe childhood traumatic brain injury.,"INTRODUCTION


Traumatic brain injury is a common cause of acquired disability during childhood. Early interventions focusing on parenting practices may prove effective at reducing negative child outcomes.
AIM


To determine the efficacy of a new counselling program aimed at parents and schools compared to a control group.
PATIENTS AND METHODS


The main study sample was obtained from a paediatric hospital. The final sample consisted of 42 children aged between 6 and 16 years old.
RESULTS


Comparing with normative data, pre-post comparisons between groups showed a significant improvement in the parent group with respect to the control group.
CONCLUSIONS


The superiority of the parental intervention group over those of the control group was not only statistically significant, but also clinically substantial and meaningful. The results of this study suggest that children with moderate to severe traumatic brain injury can benefit from an intensive supported family treatment.",2019,"The superiority of the parental intervention group over those of the control group was not only statistically significant, but also clinically substantial and meaningful.","['after moderate and severe childhood traumatic brain injury', '42 children aged between 6 and 16 years old', 'children with moderate to severe traumatic brain injury']",['new parent and school-supported intervention'],[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],42.0,0.0338323,"The superiority of the parental intervention group over those of the control group was not only statistically significant, but also clinically substantial and meaningful.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Palacio-Navarro', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez-Sala', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Colome', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Turon', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Callejon-Poo', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanz-Palau', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sans', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Poo', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boix', 'Affiliation': 'Hospital Universitari Sant Joan de Deu, Esplugues de Llobregat, Espana.'}]",Revista de neurologia,['10.33588/rn.6811.2018346']
555,31957794,Effectiveness of Proactive Tobacco Cessation Treatment Outreach Among Smokers With Serious Mental Illness.,"INTRODUCTION


People with serious mental illness (SMI) have a high smoking prevalence and low quit rates. Few cessation treatments are tested in smokers with SMI. Mental health (MH) providers are reluctant to address smoking. Proactive tobacco cessation treatment strategies reach out directly to smokers to offer counseling and medication and improve treatment utilization and quit rates. The current study is a secondary analysis of a randomized controlled trial of proactive outreach for tobacco cessation treatment in VA MH patients.
AIMS AND METHODS


Participants (N = 1938, 83% male, mean age 55.7) across four recruitment sites, who were current smokers and had a MH visit in the past 12 months, were identified using the electronic medical record. Participants were randomized to Intervention (telephone outreach call plus invitation to engage in MH tailored telephone counseling and assistance obtaining nicotine replacement therapy) or Control (usual care). The current study assessed outcomes in participants with SMI (N = 982).
RESULTS


Compared to the Control group, participants assigned to the Intervention group were more likely to engage in telephone counseling (22% vs. 3%) and use nicotine replacement therapy (51% vs. 41%). Participants in the Intervention group were more likely to be abstinent (7-day point prevalence; 18%) at 12 months than participants in the Control group (11%) but equally likely to make quit attempts.
CONCLUSIONS


Proactive tobacco cessation treatment is an effective strategy for tobacco users with SMI. Proactive outreach had a particularly strong effect on counseling utilization. Future randomized clinical trials examining proactive tobacco treatment approaches in SMI treatment settings are needed.
IMPLICATIONS


Few effective treatment models exist for smokers with SMI. Proactive tobacco cessation outreach with connections to MH tailored telephone counseling and medication promotes tobacco abstinence among smokers with SMI and is an effective treatment strategy for this underserved population.",2020,"Participants in the Intervention group were more likely to be abstinent (7-day point prevalence; 18%) at 12 months than participants in the Control group; 11%) but equally likely to make quit attempts.
","['People with serious mental illness (SMI', 'VA MH patients', 'tobacco users with SMI', 'Participants (N=1938, 83% male, mean age 55.7) across 4 recruitment sites, who were current smokers and had a MH visit in the past 12 months, were identified using the electronic medical record', 'participants with SMI (N=982', 'smokers with serious mental illness', 'smokers with SMI']","['Proactive outreach', 'Intervention (telephone outreach call plus invitation to engage in MH tailored telephone counseling and assistance obtaining nicotine replacement therapy [NRT]) or Control (usual care', 'Proactive tobacco cessation treatment', 'proactive outreach', 'Proactive tobacco cessation', 'Proactive tobacco cessation outreach with connections to mental health tailored telephone counseling and medication promotes tobacco abstinence', 'proactive tobacco cessation outreach']",['likely to engage in telephone counseling'],"[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3241966'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0563733,"Participants in the Intervention group were more likely to be abstinent (7-day point prevalence; 18%) at 12 months than participants in the Control group; 11%) but equally likely to make quit attempts.
","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Japuntich', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Hennepin Healthcare, Minneapolis, MN.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hammett', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, VA New York Harbor Healthcare System, New York, NY.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Burgess', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El Shahawy', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Melzer', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Krebs', 'Affiliation': 'Department of Mental Health, VA San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Medicine, VA New York Harbor Healthcare System, New York, NY.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa013']
556,31953483,A noninferiority within-person study comparing the accuracy of transperineal to transrectal MRI-US fusion biopsy for prostate-cancer detection.,"BACKGROUND


Magnetic resonance imaging (MRI) and ultrasound (US) fusion prostate-biopsies can be performed in a transrectal (TR-fusion) or transperineal (TP-fusion) approach. Prospective comparative evidence is limited. In this study we compared the detection rate of clinically-significant prostate-cancer (csPCa) within an index lesion between TR and TP-fusion.
PATIENTS AND METHODS


This was a prospective, noninferiority, and within-person trial. Men scheduled for MRI-US-fusion with a discrete MRI PI-RRAD ≥ 3 lesion were included. A dominant index lesion was determined for each subject and sampled by TR and TP-fusion during the same session. The order of biopsies was randomized and equipment was reset to avoid chronological and incorporation bias. For each subject, the index lesion was sampled 4-6 times in each approach. All biopsies were performed using Navigo fusion software (UC-Care, Yokneam, Israel). csPCa was defined as: Grade Group ≥ 2 or cancer-core length ≥ 6 mm. We used a noninferiority margin of 10% and a one-sided alpha level of 5%.
RESULTS


Seventy-seven patients completed the protocol. Median age was 68.2 years (IQR:64.2-72.2), median PSA was 8.9 ng/ml (IQR:6.18-12.2). Ten patients (13%) were biopsy naive, others (87%) had a previous biopsy. csPCa was detected in 32 patients (42%). All of these cases were detected by TP-fusion, while only 20 (26%) by TR-fusion. Absolute difference for csPCa diagnosis was 15.6 (CI 90% 27.9-3.2%) in favor of TP-fusion (p = 0.029). TP-fusion was noninferior to TR-fusion. The lower boundary of the 90% confidence-interval between TP-fusion and TR-fusion was greater than zero, therefore TP-fusion was also found to be superior. Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
CONCLUSIONS


In this study, TP-fusion biopsies were found to be noninferior and superior to TR-fusion biopsies in detecting csPCa within MRI-visible index lesion. Centers experienced in both TP and TR-fusion should consider these results when choosing biopsy method.",2020,"Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
","['Ten patients (13%) were biopsy naive, others (87%) had a previous biopsy', 'Men scheduled for MRI-US-fusion with a discrete MRI PI-RRAD\u2009≥\u20093 lesion were included', 'Seventy-seven patients completed the protocol']","['Magnetic resonance imaging (MRI) and ultrasound (US) fusion prostate-biopsies', 'transperineal to transrectal MRI-US fusion biopsy']","['csPCa', 'csPCa diagnosis', 'TP-fusion', 'median PSA', 'detection rate of clinically-significant prostate-cancer (csPCa']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",77.0,0.0226582,"Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
","[{'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Ber', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Niv', 'Initials': 'N', 'LastName': 'Segal', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Tamir', 'Affiliation': 'Department of Imaging, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Benjaminov', 'Affiliation': 'Division of Imaging, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Yakimov', 'Affiliation': 'Department of Pathology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Sela', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Halstauch', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kedar', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel. sdmargel@gmail.com.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0205-7']
557,31939351,Erectile function after WST11 vascular-targeted photodynamic therapy for low-risk prostate cancer treatment.,"Vascular-targeted photodynamic therapy (VTP) using padeliporfin is currently assessed as a low-risk prostate cancer (LRPCa) treatment. The aim of this study was to assess erectile function outcomes of VTP for LRPCa treatment. We prospectively included all patients treated with VTP for LRPCa. The primary endpoint was the post-treatment International Index of Erectile Function score (IIEF5 score) evolution (at 6 months, 12 months, and then every year for 5 years). Secondary endpoints were the need of erectile dysfunction (ED) treatment and its efficacy. Eighty-two men were included. The median follow-up was 68 (range: 6-89) months. There was a 3-point significant decrease in the median IIEF5 score between baseline and at 6 months post-VTP (23 [range: 1-25] vs 20 [range: 1-25], P = 0.005). There was a 1-point decrease at 1 year and 2 years post-VTP compared to baseline (22 [range: 2-25] and 22 [range: 0-25], P < 0.005). There was no significant difference at 3, 4, and 5 years compared to baseline. Twenty-seven (32.9%) patients received ED treatment: phosphodiesterase type-5 inhibitors (PDEI5; n = 18), intracavernous injections (ICI; n = 9), and intra-urethral gel (n = 1). The median IIEF5 score statistically significantly increased after ED treatment (7 [range: 0-24] vs 21 [range: 1-25], P < 0.001). ED treatment was efficient for 75% of the patients. There was no statistically significant difference between IIEF5 score at baseline and after ED treatment (P = 0.443). Forty-six patients were totally potent before VTP and among them, 13 needed ED treatment post-VTP with a success rate of 69.2%. VTP induced minimal changes in erectile function with a 3-point and a 1-point reduction in the IIEF5 score at 6 months and at 1 year, respectively. When required, ED treatment was efficient.",2020,There was no statistically significant difference between IIEF5 score at baseline and after ED treatment (P = 0.443).,"['low-risk prostate cancer treatment', 'Twenty-seven (32.9%) patients received ED treatment: phosphodiesterase type-5 inhibitors (PDEI5; n = 18', 'Eighty-two men were included']","['VTP', 'intracavernous injections (ICI; n = 9), and intra-urethral gel', 'Vascular-targeted photodynamic therapy (VTP) using padeliporfin', 'VTP for LRPCa', 'WST11 vascular-targeted photodynamic therapy']","['Erectile function', 'median IIEF5 score', 'post-treatment International Index of Erectile Function score (IIEF5 score) evolution', 'need of erectile dysfunction (ED) treatment and its efficacy', 'IIEF5 score', 'erectile function']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1160729', 'cui_str': 'Conventional release urethral gel (dose form)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C2698706', 'cui_str': 'padeliporfin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score (observable entity)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]",82.0,0.0490941,There was no statistically significant difference between IIEF5 score at baseline and after ED treatment (P = 0.443).,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Chelly', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Maulaz', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bigot', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Abdel Rahmene', 'Initials': 'AR', 'LastName': 'Azzouzi', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Souhil', 'Initials': 'S', 'LastName': 'Lebdai', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}]",Asian journal of andrology,['10.4103/aja.aja_138_19']
558,31888234,Amaranth Oil Increases Total and LDL Cholesterol Levels without Influencing Early Markers of Atherosclerosis in an Overweight and Obese Population: A Randomized Double-Blind Cross-Over Study in Comparison with Rapeseed Oil Supplementation.,"BACKGROUND


Atherosclerosis (AT) is a chronic inflammatory process in which oxidative stress is the key event. Amaranth oil (AmO) has potential hypolipidemic and antiatherogenic effects. The aim of the study was to compare the effects of AmO and rapeseed oil (RaO) supplementation on expression of early markers of AT and lipid profile in obese or overweight subjects.
METHODS


A randomized, double-blinded cross-over study was conducted, in which participants took 20 mL of AmO in the first arm and 20 mL RaO in the second arm, switching after the washout period. Serum concentrations of adhesion molecules (sP-selectin, sVCAM-1), high-sensitivity C-reactive protein (hsCRP), asymmetric dimethylarginine (ADMA), and lipid profile were assessed before and after nutritional interventions. In addition, anthropometric parameters were measured.
RESULTS


The total (TC) and low-density lipoprotein (LDL) cholesterol concentrations increased significantly in the AmO group in comparison with RaO (ΔTC 5.52 ± 35 vs. -8.43 ± 17.65 mg/dL;  p  = 0.002 and 4.43 ± 34.96 vs. -7.55 ± 16.41 mg/dL;  p  = 0.002, respectively). There were no significant differences in other parameters analyzed between the groups.
CONCLUSION


The use of AmO instead of RaO may increase cardiovascular risk in obese and overweight subjects.",2019,"Serum concentrations of adhesion molecules (sP-selectin, sVCAM-1), high-sensitivity C-reactive protein (hsCRP), asymmetric dimethylarginine (ADMA), and lipid profile were assessed before and after nutritional interventions.","['obese and overweight subjects', 'Overweight and Obese Population', 'participants took 20 mL of AmO in the first arm and 20 mL RaO in the second arm, switching after the washout period', 'obese or overweight subjects']","['AmO and rapeseed oil (RaO) supplementation', 'Rapeseed Oil Supplementation', 'Amaranth Oil', 'Amaranth oil (AmO']","['expression of early markers of AT and lipid profile', 'LDL) cholesterol concentrations', 'cardiovascular risk', 'Serum concentrations of adhesion molecules (sP-selectin, sVCAM-1), high-sensitivity C-reactive protein (hsCRP), asymmetric dimethylarginine (ADMA), and lipid profile', 'total (TC) and low-density lipoprotein ', 'Total and LDL Cholesterol Levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0072982', 'cui_str': 'rapeseed oil'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.203212,"Serum concentrations of adhesion molecules (sP-selectin, sVCAM-1), high-sensitivity C-reactive protein (hsCRP), asymmetric dimethylarginine (ADMA), and lipid profile were assessed before and after nutritional interventions.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Dus-Zuchowska', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 60-572 Poznan, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 60-572 Poznan, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Morawska', 'Affiliation': 'Department of Bromatology, Poznan University of Medical Sciences, 60-354 Poznan, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Krzyzanowska-Jankowska', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 60-572 Poznan, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Miskiewicz-Chotnicka', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 60-572 Poznan, Poland.'}, {'ForeName': 'Juliusz', 'Initials': 'J', 'LastName': 'Przyslawski', 'Affiliation': 'Department of Bromatology, Poznan University of Medical Sciences, 60-354 Poznan, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 60-572 Poznan, Poland.'}]",Nutrients,['10.3390/nu11123069']
559,31888241,"Berberis aristata ,  Elaeis guineensis  and  Coffea canephora  Extracts Modulate the Insulin Receptor Expression and Improve Hepatic Steatosis in NAFLD Patients: A Pilot Clinical Trial.","Non-alcoholic fatty liver disease (NAFLD) is associated with insulin resistance and diabetes. A reduction in insulin receptor (IR) expression has been reported in these patients. The aims of this study were to evaluate the effects of a mixture of plant extracts consisting of  Berberis aristata ,  Elaeis guineensis  and decaffeinated green coffee by  Coffea canephora  on the improvement of glycaemic profile, through the modulation of IR levels, and of hepatic steatosis in NAFLD patients. Forty-nine patients with a grade of steatosis S1-S2 were randomly allocated to the treatment with plant extracts or placebo for six months. Hepatic steatosis was evaluated using transient elastography with CAP (controlled attenuation parameter). Glucose, insulin, and IR levels were measured in serum samples. At the end of the study, patients treated with plant extracts displayed a significant reduction of serum glucose ( p  < 0.001), insulin levels ( p  < 0.01), homeostatic model assessment for insulin resistance (HOMA-IR) index ( p  < 0.001), and CAP value ( p  < 0.01) compared to placebo. Moreover, the IR expression was increased significantly in the plant extracts group compared to the placebo group ( p  < 0.05). The combination of plant extracts increases serum IR levels, determining amelioration of glycemic profile and improvement of hepatic steatosis in NAFLD patients.",2019,"The combination of plant extracts increases serum IR levels, determining amelioration of glycemic profile and improvement of hepatic steatosis in NAFLD patients.","['Forty-nine patients with a grade of steatosis S1-S2', 'NAFLD Patients', 'NAFLD patients']","['placebo', 'plant extracts or placebo', 'plant extracts', 'mixture of plant extracts consisting of  Berberis aristata ,  Elaeis guineensis  and decaffeinated green coffee']","['Glucose, insulin, and IR levels', 'Hepatic steatosis', 'CAP value', 'serum glucose', 'insulin levels', 'insulin receptor (IR) expression', 'hepatic steatosis', 'homeostatic model assessment for insulin resistance (HOMA-IR) index ', 'IR expression', 'serum IR levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032081', 'cui_str': 'Plant Extracts'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0949843', 'cui_str': 'Barberry'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0034818', 'cui_str': 'Insulin Receptor'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",49.0,0.0623261,"The combination of plant extracts increases serum IR levels, determining amelioration of glycemic profile and improvement of hepatic steatosis in NAFLD patients.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cossiga', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Lembo', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Guarino', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Tuccillo', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Campania ""Luigi Vanvitelli"", 80131 Naples, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morando', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Pontillo', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fiorentino', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Caporaso', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Morisco', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 80131 Naples, Italy.'}]",Nutrients,['10.3390/nu11123070']
560,31934788,Starting Early Program Impacts on Feeding at Infant 10 Months Age: A Randomized Controlled Trial.,"Background:  Disparities in obesity-promoting feeding patterns begin in pregnancy and infancy, underscoring the need for early primary prevention in high-risk groups. We sought to determine the impact of a primary care-based child obesity prevention intervention beginning during pregnancy on maternal infant feeding practices, knowledge, and styles at 10 months in low-income Hispanic families.  Methods:  The Starting Early Program (StEP) randomized controlled trial enrolled pregnant women at a third trimester visit. Women ( n  = 533) were randomized to standard care or an intervention with prenatal/postpartum individual nutrition counseling and nutrition and parenting support groups coordinated with pediatric visits. Feeding practices (breastfeeding, family meals, juice, and cereal in the bottle) were assessed using questions from the Infant Feeding Practices Study II. Feeding styles were assessed using the Infant Feeding Style Questionnaire. We analyzed impacts on feeding practices, knowledge, and styles using regression analyses adjusting for covariates.  Results:  Four hundred twelve mothers completed 10-month assessments. Intervention mothers were more likely to give breast milk as the only milk source [adjusted odds ratio (AOR) 1.65, 95% confidence interval (CI) 1.06-2.58] and have daily family meals (AOR 1.91, 95% CI 1.19-3.05), and less likely to give juice (AOR 0.60, 95% CI 0.39-0.92) or cereal in the bottle (AOR 0.54, 95% CI 0.30-0.97) compared to controls. Intervention mothers were more likely to exhibit lower pressuring, indulgent and laissez-faire feeding styles, and to have higher knowledge. Attending a greater number of group sessions increased intervention impacts.  Conclusions:  StEP led to reduced obesity-promoting feeding practices and styles, and increased knowledge and provides great potential for population-scalability.",2020,"Intervention mothers were more likely to exhibit lower pressuring, indulgent and laissez-faire feeding styles, and to have higher knowledge.","['low-income Hispanic families', 'Women ( n \u2009=\u2009533', 'Feeding at Infant 10 Months Age', 'Four hundred twelve mothers completed 10-month assessments', 'enrolled pregnant women at a third trimester visit']","['standard care or an intervention with prenatal/postpartum individual nutrition counseling and nutrition and parenting support groups coordinated with pediatric visits', 'primary care-based child obesity prevention intervention']",['daily family meals'],"[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]",412.0,0.0913048,"Intervention mothers were more likely to exhibit lower pressuring, indulgent and laissez-faire feeding styles, and to have higher knowledge.","[{'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Katzow', 'Affiliation': ""Department of Pediatrics, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Cohen Children's Medical Center, New Hyde Park, NY, USA.""}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY, USA.'}]",Childhood obesity (Print),['10.1089/chi.2019.0236']
561,31926484,Body composition and neuromotor development in the year after NICU discharge in premature infants.,"BACKGROUND


Hypothesis: neuromotor development correlates to body composition over the first year of life in prematurely born infants and can be influenced by enhancing motor activity.
METHODS


Forty-six female and 53 male infants [27 ± 1.8 (sd) weeks] randomized to comparison or exercise group (caregiver provided 15-20 min daily of developmentally appropriate motor activities) completed the year-long study. Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS) were assessed.
RESULTS


AIMS at 1 year correlated with LBM (r = 0.32, p < 0.001) in the whole cohort. However, there was no effect of the intervention. LBM increased by ~3685 g (p < 0.001)); insulin-like growth factor-1 (IGF-1) was correlated with LBM (r = 0.36, p = 0.002). IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125). LBM and bone mineral density were significantly lower and IGF-1 higher in the females at 1 year.
CONCLUSIONS


We found an association between neuromotor development and LBM suggesting that motor activity may influence LBM. Our particular intervention was ineffective. Whether activities provided largely by caregivers to enhance motor activity in prematurely born infants can affect the interrelated (1) balance of growth and inflammation mediators, (2) neuromotor development, (3) sexual dimorphism, and/or (4) body composition early in life remains unknown.",2020,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","['Forty-six female and 53 male infants [27\u2009±\u20091.8 (sd) weeks', 'prematurely born infants', 'premature infants']",['randomized to comparison or exercise group (caregiver provided 15-20\u2009min daily of developmentally appropriate motor activities'],"['IL-1RA (an inflammatory biomarker', 'Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS', 'insulin-like growth factor-1 (IGF-1', 'Body composition and neuromotor development', 'motor activity', 'LBM and bone mineral density', 'LBM']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0222045'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",46.0,0.0798796,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","[{'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Cooper', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA. dcooper@hs.uci.edu.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kepes', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Candice Taylor', 'Initials': 'CT', 'LastName': 'Lucas', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Fadia', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zalidvar', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Nitzan', 'Initials': 'N', 'LastName': 'Dror', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Soliman', 'Affiliation': ""Miller Women's and Children's Hospital, Long Beach, CA, USA.""}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}]",Pediatric research,['10.1038/s41390-020-0756-2']
562,31927647,"""Comparative study between the efficacy of fractional CO2 laser, Q-switched Nd:YAG laser (1064 nm), and both types in treatment of keratosis pilaris"".","The aim of this study was to assess and compare the efficacy of fractional CO2 laser, Q-switched Nd:YAG laser (1064 nm), and their combined use in treatment of keratosis pilaris. The study included twenty female patients. For each patient, three areas were randomly assigned to treatment by either fractional CO2 laser (area A) or Q-switched laser (1064 nm) (area C), or both types of laser (area B). All patients were assessed by digital photography at baseline and 1 month after the last session. Assessment was done by two non-blinded and two blinded investigators (blinded investigators do not know which area is treated with which machine and non-blinded knows). Patients reported the degree of satisfaction or any adverse effects also after 1 month from the last session. The three treatment modalities led to overall improvement in the KP lesions. According to patients' score and investigator two, area B showed statistically significant improvement compared to areas A and C (p=0.001 and p=0.039, respectively). The first blinded investigators' assessment revealed that there was statistically significant improvement in area C compared to A and B (p = 0.023). The assessment of both investigator one and the second blinded investigator revealed that there was improvement in the three areas with no statistically significant difference between them. Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.",2020,Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.,"['twenty female patients', 'keratosis pilaris']","['fractional CO2 and Q-switched Nd:YAG laser', 'fractional CO2 laser (area A) or Q-switched laser', 'fractional CO2 laser, Q-switched Nd:YAG laser']",['degree of satisfaction or any adverse effects'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0870082', 'cui_str': 'Hyperkeratosis of skin'}]","[{'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1956123', 'cui_str': 'Q-Switched Lasers'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",20.0,0.0294406,Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.,"[{'ForeName': 'Rehab Mohamed', 'Initials': 'RM', 'LastName': 'Sobhi', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt. sobhirehab@yahoo.com.'}, {'ForeName': 'Nada Adel Hassan', 'Initials': 'NAH', 'LastName': 'Adawy', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt.'}, {'ForeName': 'Iman Sany', 'Initials': 'IS', 'LastName': 'Zaky', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt.'}]",Lasers in medical science,['10.1007/s10103-020-02956-w']
563,31928085,Scandcleft Project Trial 3: Comparison of Speech Outcomes in Relation to Sequence in 2-Stage Palatal Repair Procedures in 5-Year-Olds With Unilateral Cleft Lip and Palate.,"OBJECTIVE


To compare speech outcome following different sequencing of hard and soft palate closure between arms and centers within trial 3 and compare results to peers without cleft palate.
DESIGN


A prospective randomized clinical trial.
SETTING


Two Norwegian and 2 British centers.
PARTICIPANTS


One hundred thirty-six 5-year-olds with unilateral cleft lip and palate were randomized to either lip and soft palate closure at 3 to 4 months and hard palate closure at 12 months (arm A) or lip and hard palate closure at 3 to 4 months and soft palate closure at 12 months (arm D).
MAIN OUTCOME MEASURES


A composite measure of velopharyngeal competence (VPC), overall assessment of VPC from connected speech (VPC-Rate). Percentage of consonants correct (PCC), active cleft speech characteristics (CSCs), subdivided by oral retracted and nonoral errors, and developmental speech characteristics (DSCs).
RESULTS


Across the trial, 47% had VPC, with no statistically significant difference between arms within or across centers. Thirty-eight percent achieved a PCC score of >90%, with no difference between arms or centers. In one center, significantly more children in arm A produced ≥3 active CSCs ( P  < .05). Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D).
CONCLUSIONS


Less than half of the 5-year-olds achieved VPC and around one-third achieved age-appropriate PCC scores. Cleft speech characteristics were more common in arm A, but outcomes varied within and across centers. Thus, outcome of the same surgical method can vary substantially across centers.",2020,"Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D).
","['peers without cleft palate', 'One hundred thirty-six 5-year-olds with unilateral cleft lip and palate', '5-Year-Olds With Unilateral Cleft Lip and Palate', 'Two Norwegian and 2 British centers']","['lip and soft palate closure at 3 to 4 months and hard palate closure at 12 months ', 'lip and hard palate closure at 3 to 4 months and soft palate closure']","['PCC score', 'active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D', 'Percentage of consonants correct (PCC), active cleft speech characteristics (CSCs), subdivided by oral retracted and nonoral errors, and developmental speech characteristics (DSCs', 'velopharyngeal competence (VPC), overall assessment of VPC from connected speech (VPC-Rate']","[{'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0030219', 'cui_str': 'Velum Palatinum'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}]","[{'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.217497,"Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D).
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Persson', 'Affiliation': 'Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Nina-Helen', 'Initials': 'NH', 'LastName': 'Pedersen', 'Affiliation': 'Statped Vest, Bergen, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hayden', 'Affiliation': 'The Royal Hospital for Sick Children, Belfast, Northern Ireland.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bowden', 'Affiliation': ""Greater Manchester Cleft Unit, Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Aukner', 'Affiliation': 'Department of Speech and Language Disorders, Statped sørøst, Oslo, Norway.'}, {'ForeName': 'Hallvard A', 'Initials': 'HA', 'LastName': 'Vindenes', 'Affiliation': 'Center for Cleft Lip and Palate, Bergen University Hospital Haukeland, Bergen, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Åbyholm', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Withby', 'Affiliation': ""Greater Manchester Cleft Unit, Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lohmander', 'Affiliation': 'Division of Speech and Language Pathology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619896637']
564,31444839,"Relationships Between Allopurinol Dose, Oxypurinol Concentration and Urate-Lowering Response-In Search of a Minimum Effective Oxypurinol Concentration.","The aims of this study were to determine factors that predict serum urate (SU) lowering response to allopurinol and the conversion of allopurinol to oxypurinol, and to determine a minimum therapeutic oxypurinol concentration. Data from 129 participants in a 24-month open, randomized, controlled, parallel-group, comparative clinical trial were analyzed. Allopurinol dose, SU, and plasma oxypurinol concentrations were available at multiple time points. The slope for the association between allopurinol dose and SU was calculated as a measure of sensitivity to allopurinol. The slope for the association between allopurinol dose and oxypurinol was calculated as a measure of allopurinol metabolism. Receiver operating characteristic (ROC) curves were used to identify a minimum oxypurinol concentration predictive of SU < 6 mg/dL. There was a wide range of SU concentrations for each allopurinol dose. The relationship between sensitivity to allopurinol and allopurinol metabolism for each 100 mg allopurinol dose increase varied between individuals. Body mass index (P = 0.023), creatinine clearance (CrCL; P = 0.037), ABCG2 Q141K (P = 0.019), and SU (P = 0.004) were associated with sensitivity to allopurinol. The minimum oxypurinol concentration for achieving the urate target was found to be about 104 μmol/L, but predictive accuracy was poor (ROC curve area under the curve (AUC) 0.65). The minimum therapeutic oxypurinol concentration was found to increase with decreasing renal function. Although there is a positive relationship between change in oxypurinol and change in SU concentration, a minimum therapeutic oxypurinol is dependent on CrCL and cannot reliably predict SU target. Other variables, including ABCG2 Q141K genotype, impact on sensitivity to allopurinol (ACTRN12611000845932).",2020,"Body mass index (P = 0.023), creatinine clearance (CrCL; P = 0.037), ABCG2 Q141K (P = 0.019), and SU (P = 0.004) were associated with sensitivity to allopurinol.",['129 participants in a 24-month open'],"['Allopurinol', 'allopurinol', 'allopurinol and allopurinol metabolism']","['minimum oxypurinol concentration', 'Body mass index', 'creatinine clearance', 'Oxypurinol Concentration and Urate-Lowering Response', 'SU, and plasma oxypurinol concentrations', 'ABCG2 Q141K', 'SU', 'renal function', 'SU concentrations']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]","[{'cui': 'C0030086', 'cui_str': 'Alloxanthine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",129.0,0.0308703,"Body mass index (P = 0.023), creatinine clearance (CrCL; P = 0.037), ABCG2 Q141K (P = 0.019), and SU (P = 0.004) were associated with sensitivity to allopurinol.","[{'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Stamp', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Chapman', 'Affiliation': 'Department of Rheumatology, Immunology, and Allergy, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Barclay', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Tony R', 'Initials': 'TR', 'LastName': 'Merriman', 'Affiliation': 'Department of Biochemistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Daniel F B', 'Initials': 'DFB', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Drake', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}]",Clinical and translational science,['10.1111/cts.12686']
565,31906814,Functional Resistance Training Superiority Over Conventional Training in Metabolic Syndrome: A Randomized Clinical Trial.,"Metabolic syndrome (MetS) is a growing epidemic related with higher values of blood pressure (BP) and autonomic dysfunction. Scientific evidence has been indicating that functional resistance training (FRT) is superior over conventional (CRT) for muscle fatigue and pain, yet its effects on autonomic modulation (AM), BP and heart rate in MetS are unclear. We theorized that FRT can be superior to CRT in MetS patients because of larger muscle activation. This study compares FRT and CRT on AM, blood pressure, heart rate and muscle strength. Thirty-eight sex and age matched individuals (40 to 60 years) were randomized for FRT or CRT, with training intensity varying gradually from 30%-100% of one maximal repetition test (1MR), 3 times/week for 30 sessions. All outcomes were evaluated at baseline and post training. AM was assessed by heart rate variability (mean RR, RMSSD, SDNN, LF, HF, TINN, RRtri, SD1 and SD2). BP (mmHg) was obtained by cuff measures. Muscle strength was assessed by 1MR. An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms   2  ∆80%). Moreover, just FRT was capable of reducing BP post intervention (SBP from 129.21 ± 19.02 to 118.94 ± 14.14 mmHg,  p  < .009,/d/ = 0.49; DBP from 85.26 ± 11.48 to 77.76 ± 8.93 mmHg,  p  < .01,/d/ = 0.51). Both groups had a similar increase in muscle strength and no changes between HR. Progressive FRT was more beneficial to CRT regarding AM, increasing vagal activity, and reducing blood pressure in MetS individuals.",2020,An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms 2  ∆80%).,"['Metabolic Syndrome', 'Thirty-eight sex and age matched individuals (40 to 60\xa0years']","['FRT or CRT', 'FRT', 'functional resistance training (FRT) is superior over conventional (CRT', 'Functional Resistance Training Superiority over Conventional Training']","['AM, blood pressure, heart rate and muscle strength', 'cardiac parasympathetic activity', 'Muscle strength', 'muscle strength', 'vagal activity', 'blood pressure (BP) and autonomic dysfunction', 'autonomic modulation (AM), BP and heart rate', 'blood pressure', 'BP (mmHg', 'heart rate variability (mean RR, RMSSD, SDNN, LF, HF, TINN, RRtri, SD1 and SD2']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}]",38.0,0.0184077,An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms 2  ∆80%).,"[{'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Turri-Silva', 'Affiliation': 'University of Brasilia.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Ricci-Vitor', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Cipriano', 'Affiliation': 'University of Brasilia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garner', 'Affiliation': 'Oxford Brookes University.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Netto', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Giacon', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Diego Giulliano', 'Initials': 'DG', 'LastName': 'Destro Christofaro', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'Marques Vanderlei', 'Affiliation': 'Oxford Brookes University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1679333']
566,30626911,"A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.","NSI-189 is a novel neurogenic compound independent of monoamine reuptake pathways. This trial evaluated oral NSI-189 as monotherapy in major depressive disorder. To improve signal detection, the sequential-parallel comparison design (SPCD) was chosen. Two hundred and twenty subjects were randomized to NSI-189 40 mg daily, 80 mg daily, or placebo for 12 weeks. The primary outcome measure was the Montogmery Asberg Depression Rating Scale (MADRS). Secondary subject-rated measures included the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests. MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively). However, the 40 mg dose showed greater overall reduction in SDQ (pooled mean difference -8.2; Cohen's d for Stages 1 and 2 = -0.11 and -0.64, p = 0.04), and CPFQ scores (pooled mean difference -1.9; Cohen's d for Stages 1 and 2 = -0.28 and -0.47, p = 0.03) versus placebo, as well as QIDS-SR scores in Stage 2 of SPCD (-2.5; Cohen's d Stages 1 and 2 = -0.03 and -0.68, p = 0.04). The 40 mg dose also showed advantages on some objective cognitive measures of the CogScreen (absolute Cohen's d ranged between 0.12 and 1.12 in favor of NSI-189, p values between 0.002 and 0.048 for those with overall significance), but not the Cogstate test. Both doses were well tolerated. These findings replicate those of phase 1b study, and warrant further exploration of the antidepressant and pro-cognitive effects of NSI-189.",2020,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","['major depressive disorder', 'Two hundred and twenty subjects were randomized to NSI-189 40', 'outpatients with major depressive disorder']","['NSI-189 phosphate', 'NSI-189', 'placebo']","['Montogmery Asberg Depression Rating Scale (MADRS', 'MADRS score reduction', 'Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests', 'QIDS-SR scores', 'tolerated', 'overall reduction in SDQ', 'objective cognitive measures of the CogScreen', 'CPFQ scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",220.0,0.16936,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA. gpapakostas@partners.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johe', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hand', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corp., Saint Petersburg, Florida, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kashambwa', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martinson', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0334-8']
567,31919654,Kinesiology training in patients with Parkinson's disease: results of a pilot study.,"Complementary therapies are an essential component of the treatment of patients with Parkinson's disease. They aim to ameliorate disease symptoms in conjunction with dopamine substitution. Kinesiology trains about the effective use of physical, mental and emotional skills. Objectives of this pilot study were to demonstrate the efficacy of a standardised kinesiology programme in 20 patients with Parkinson's disease. They were on a stable drug regimen during the whole trial. Ten patients received two kinesiology sessions per week over a 6-week lasting interval. The remaining ten patients were only followed over the same time period without any kinesiology training. We scored disease symptoms, tested cognition and assessed instrumental movement performance at baseline and study end. Kinesiology improved disease symptoms, cognitive abilities and execution of simple but not complex movement series. We show a certain value of a standardised kinesiology programme as adjunct, complementary therapeutic approach in patients with Parkinson's disease.",2020,"Kinesiology improved disease symptoms, cognitive abilities and execution of simple but not complex movement series.","[""20 patients with Parkinson's disease"", ""patients with Parkinson's disease""]","['dopamine substitution', 'Kinesiology training', 'standardised kinesiology programme']","['disease symptoms, cognitive abilities and execution of simple but not complex movement series']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]",,0.018337,"Kinesiology improved disease symptoms, cognitive abilities and execution of simple but not complex movement series.","[{'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Kuhn', 'Affiliation': 'Department of Neurology, Leopoldina Hospital Schweinfurt, Gustav Adolf Str. 8, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Neufeld', 'Affiliation': 'Department of Neurology, Leopoldina Hospital Schweinfurt, Gustav Adolf Str. 8, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Müller', 'Affiliation': 'Department of Neurology, St. Joseph Hospital Berlin-Weissensee, Gartenstr. 1, 13088, Berlin, Germany. th.mueller@alexianer.de.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-019-02123-8']
568,31101513,Co-treatment of buspirone with atypical antipsychotic drugs (AAPDs) improved neurocognitive function in chronic schizophrenia.,"We conducted a 24-week, randomized, double-blind parallel-controlled trial to test whether buspirone is beneficial to improve cognitive deficits of schizophrenia because it remains unclear. Two hundred patients received in random order either co-treatment buspirone with AAPDs or monotherapy with AAPDs. All patients had been treated with a stable dosage of AAPDs for at least three months. The positive and negative syndrome scale (PANSS), Hamilton Depression Scale-24 (HAMD-24), and 14-item Hamilton Rating Scale for Anxiety (HAMA-14) were used to evaluate clinical symptoms. The short version of Wechsler Adult Intelligence Scale-Revised in China (WAIS-RC) was used to assess neurocognitive function. Social function and family burden were evaluated by Social Disability Screening Schedule (SDSS) and Family Burden Interview Schedule (FBIS). All patients were enrolled at baseline and followed up after 12 and 24 weeks. A total of 196 patients completed the trial, with 99 in the combined treatment group and 97 in the control group. During the intervention, the score of PANSS, HAMD-24, and HAMA-14 decreased slightly without group differences. Repeated measures ANOVA showed significant differences between the two groups in the score of arithmetic, similarities, picture completion, block design, SDSS, and FBIS (P < 0.05), but no difference was found with regard to the score of information, digital span test, or digital symbols (P > 0.05). In conclusion, co-treatment with buspirone and APPDs outperformed APPDs alone in improving cognitive deficit and reducing family burden of schizophrenia. Buspirone may be a promising candidate for co-treatment of schizophrenia-associated cognitive deficits.",2019,"Repeated measures ANOVA showed significant differences between the two groups in the score of arithmetic, similarities, picture completion, block design, SDSS, and FBIS (P < 0.05), but no difference was found with regard to the score of information, digital span test, or digital symbols (P > 0.05).","['All patients were enrolled at baseline and followed up after 12 and 24\u202fweeks', '196 patients completed the trial, with 99 in the combined treatment group and 97 in the control group', 'Two hundred patients received in random order either co-treatment', 'chronic schizophrenia']","['buspirone with atypical antipsychotic drugs (AAPDs', 'Buspirone', 'buspirone with AAPDs or monotherapy with AAPDs', 'buspirone']","['score of PANSS, HAMD-24, and HAMA-14', 'score of information, digital span test, or digital symbols', 'Social function and family burden', 'short version of Wechsler Adult Intelligence Scale-Revised in China (WAIS-RC', 'Social Disability Screening Schedule (SDSS) and Family Burden Interview Schedule (FBIS', 'cognitive deficit and reducing family burden of schizophrenia', 'neurocognitive function', 'score of arithmetic, similarities, picture completion, block design, SDSS, and FBIS', 'positive and negative syndrome scale (PANSS), Hamilton Depression Scale-24 (HAMD-24), and 14-item Hamilton Rating Scale for Anxiety (HAMA-14']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia (disorder)'}]","[{'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C1276996', 'cui_str': 'Atypical antipsychotic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0451572', 'cui_str': 'Wechsler Adult Intelligence Scale-Revised'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",200.0,0.0342723,"Repeated measures ANOVA showed significant differences between the two groups in the score of arithmetic, similarities, picture completion, block design, SDSS, and FBIS (P < 0.05), but no difference was found with regard to the score of information, digital span test, or digital symbols (P > 0.05).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Liansheng', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China; National Clinical Research Center on Mental Disorders (Changsha) of China, Changsha, China.'}, {'ForeName': 'Jinxue', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China; National Clinical Research Center on Mental Disorders (Changsha) of China, Changsha, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dazhou Mental Health Center, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Dazhou Mental Health Center, China.'}, {'ForeName': 'Congyu', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Mental Hospital of Liangshan Yi Autonomous Prefecture, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Mental Hospital of Liangshan Yi Autonomous Prefecture, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Wanjun', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Psychiatric Laboratory and Mental Health Center, West China Hospital of Sichuan University, Chengdu, China; West China Brain Research Center, West China Hospital of Sichuan University, Chengdu, China. Electronic address: maxiaohong@scu.edu.cn.'}]",Schizophrenia research,['10.1016/j.schres.2019.05.006']
569,31794072,"Pharmacodynamic and pharmacokinetic profile of SM-1, a triple-drug combination to increase total sleep time.","OBJECTIVE


The primary objective was to characterize the pharmacokinetics and pharmacodynamics of SM-1 after administration of a single oral dose to healthy volunteers in a placebo-controlled double-blind trial of daytime sedation. Secondary objectives were to determine the onset, duration, and offset of the sedative effects using subjective and objective measures of sedation. Safety and tolerability of SM-1 were also investigated.
METHODS


Males and females 18-45 years of age received SM-1, a combination drug product comprised of diphenhydramine, zolpidem (delayed release), and lorazepam (delayed release). The pharmacokinetic profile of each drug was determined from blood samples. Sedative effects were assessed by visual analog scale, digit symbol substitution test, memory test, and quantitative electroencephalography.
RESULTS


Similar number and severity of adverse events were observed following administration of SM-1 and placebo. Onset of sedation, as determined by subjective, performance, and electroencephalography measures, occurred 0.5-1 hr postdose, lasting about 7-7.5 hr. Plasma concentration curves for the two delayed-release components were altered compared with published data for unmodified drugs. Exposure values obtained with the combination product were in good agreement with published values of the drugs given individually.
CONCLUSIONS


SM-1 was well tolerated and has pharmacologic activity starting within an hour of ingestion, lasting approximately 7-8 hr. Sedative activity was seen with subjective, psychomotor, and electroencephalography assays.",2019,Similar number and severity of adverse events were observed following administration of SM-1 and placebo.,"['Males and females 18-45 years of age received SM-1, a combination drug product comprised of', 'healthy volunteers in a placebo-controlled double-blind trial of daytime sedation']","['SM-1 and placebo', 'diphenhydramine, zolpidem (delayed release), and lorazepam', 'SM-1']","['Sedative effects', 'total sleep time', 'Sedative activity', 'visual analog scale, digit symbol substitution test, memory test, and quantitative electroencephalography', 'Plasma concentration curves', 'onset, duration, and offset of the sedative effects using subjective and objective measures of sedation', 'Safety and tolerability of SM-1', 'Similar number and severity of adverse events', 'subjective, performance, and electroencephalography measures']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C3179159', 'cui_str': 'Sedative Effect'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.150366,Similar number and severity of adverse events were observed following administration of SM-1 and placebo.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dahl', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Lan Bo', 'Initials': 'LB', 'LastName': 'Chen', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'CRST Oy, Turku, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Suopanki-Lalowski', 'Affiliation': 'Crown CRO Oy, Espoo, Finland.'}, {'ForeName': 'Marju', 'Initials': 'M', 'LastName': 'Valge', 'Affiliation': 'StatFinn Estonia OÜ, Tartu, Estonia.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Puhakka', 'Affiliation': 'Suomen Neurolaboratorio Oy, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Mikola', 'Affiliation': 'Suomen Neurolaboratorio Oy, Turku, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'CRST Oy, Turku, Finland.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Meierjohann', 'Affiliation': 'Turku University Hospital, Institute of Biomedicine, and TYKSLAB, University of Turku, Turku, Finland.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Vuorilehto', 'Affiliation': 'Turku University Hospital, Institute of Biomedicine, and TYKSLAB, University of Turku, Turku, Finland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Sleep Disorders and Research, Henry Ford Hospital Sleep Disorders Center, Detroit, Michigan.'}]",Human psychopharmacology,['10.1002/hup.2716']
570,31893232,Defining Characteristics of Nodal Disease on PET/CT Scans in Patients With HIV-Positive and -Negative Locally Advanced Cervical Cancer in South Africa.,"Literature reports increased FDG nodal uptake in HIV-positive patients. Our aim is to identify differences in presentation and characteristics of FDG-avid lymph nodes between HIV-positive and HIV-negative locally advanced cervical cancer (LACC) patients in our clinical setting. We evaluated 250 pre-treatment  18 F-FDG PET/CT imaging studies from women screened for a phase III randomised controlled trial investigating modulated electro-hyperthermia as a radiosensitiser (Ethics approval: M120477). The number of nodes; size; maximum standardised uptake value (SUVmax); symmetry; and relationship between nodal size and SUVmax uptake, were assessed by region and by HIV status. In total, 1314 nodes with a SUVmax ≥ 2.5 were visualised. Of 128(51%) HIV-positive participants, 82% were on antiretroviral therapy (ART) and 10 had a CD4 count <200 cells/µL. Overall pattern of presentation and nodal characteristics were similar between HIV-positive and -negative groups and the uniformity in presentation of the nodes draining the cervix strongly suggests these nodes may be attributed to malignancy rather than HIV infection. Novel findings: HIV infection is associated with: >four nodes visualised in the neck, symmetrical inguinal lymph nodes, increased rates of supraclavicular node visualisation; FDG-avid axillary nodes were more common, but not exclusive, in HIV-positive participants.  18 F-FDG PET/CT is a reliable staging method for LACC in HIV-positive patients who are not in acute stages of HIV infection, have a CD4 count >200 cells/µL, and/or are on ART and there is a potential risk of underestimating metastatic spread by attributing increased nodal metabolic activity to HIV infection in these patients.",2019,"18 F-FDG PET/CT is a reliable staging method for LACC in HIV-positive patients who are not in acute stages of HIV infection, have a CD4 count","['In total, 1314 nodes with a SUVmax ≥ 2.5 were visualised', 'HIV-positive patients', 'Patients With HIV-Positive and -Negative Locally Advanced Cervical Cancer in South Africa', 'HIV-positive and HIV-negative locally advanced cervical cancer (LACC) patients']",[],"['FDG nodal uptake', 'number of nodes; size; maximum standardised uptake value (SUVmax); symmetry; and relationship between nodal size and SUVmax uptake', 'CD4 count']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}]",[],"[{'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",,0.272818,"18 F-FDG PET/CT is a reliable staging method for LACC in HIV-positive patients who are not in acute stages of HIV infection, have a CD4 count","[{'ForeName': 'Carrie Anne', 'Initials': 'CA', 'LastName': 'Minnaar', 'Affiliation': 'Division of Radiobiology, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ans', 'Initials': 'A', 'LastName': 'Baeyens', 'Affiliation': 'Division of Radiobiology, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Olusegun Akinwale', 'Initials': 'OA', 'LastName': 'Ayeni', 'Affiliation': 'Department of Nuclear Medicine, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Jeffrey Allan', 'Initials': 'JA', 'LastName': 'Kotzen', 'Affiliation': 'Department of Radiation Oncology, Wits Donald Gordon Medical Centre, Johannesburg, South Africa; and.'}, {'ForeName': 'Mboyo-Di-Tamba', 'Initials': 'MD', 'LastName': 'Vangu', 'Affiliation': 'Department of Nuclear Medicine, Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]","Tomography (Ann Arbor, Mich.)",['10.18383/j.tom.2019.00017']
571,31448488,Comparative Effects of One-Shot Electrical Stimulation on Performance of the Flexor Hallucis Longus Muscle in Professional Dancers: Percutaneous Versus Transcutaneous?,"OBJECTIVE


High demand of flexor hallucis longus (FHL) in the positions of extreme flexion of the ankle and toes is required in the dance. The aim was to investigate the effects of single-shot of ultrasound-guided percutaneous neuromodulation (PNM) vs. single-shot of transcutaneous electrical nerve stimulation (TENS) in performance of the FHL muscle in professional dancers.
MATERIALS AND METHODS


Thirty-two female healthy dancers were divided into two groups: TENS group and PNM group. The stimulation interventions consisted in the application of a square wave biphasic electrical current for a total of 1.5 mins. Range of motion (ROM) of first metatarsophalangeal joint, balance test, and unilateral heel raise fatigue test were performed in dominance limb.
RESULTS


There were no differences between both groups in the baseline measurements. Compared to their baseline values, the TENS group statistically improved balance (p < 0.01, d = 0.6), ROM (p < 0.001, d = 0.3), and endurance (p = 0.04, d = 0.5). The PNM group only statistically improved balance and endurance (p < 0.001), with a large effect size for both test (d = 0.8 and d = 2.24, respectively). After interventions, there were no significant differences between TENS and PNM groups for all variables. However, PNM was qualitatively more effective because the percentage change in mean was greater and effect size was large for the balance test and endurance test.
CONCLUSIONS


Simple single-shot procedure with percutaneous or TENS provided immediate performance improvement of FHL muscle in dancers, being PNM the more effective intervention.",2020,"The PNM group only statistically improved balance and endurance (p < 0.001), with a large effect size for both test (d = 0.8 and d = 2.24, respectively).",['Thirty-two female healthy dancers'],"['TENS', 'single-shot of ultrasound-guided percutaneous neuromodulation (PNM) vs. single-shot of transcutaneous electrical nerve stimulation (TENS', 'flexor hallucis longus (FHL', 'TENS group and PNM', 'One-Shot Electrical Stimulation']","['balance and endurance', 'balance', 'Range of motion (ROM) of first metatarsophalangeal joint, balance test, and unilateral heel raise fatigue test', 'ROM']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0335081', 'cui_str': 'Dancer (occupation)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0224473', 'cui_str': 'Flexor hallucis longus muscle structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal Joint'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",32.0,0.0253924,"The PNM group only statistically improved balance and endurance (p < 0.001), with a large effect size for both test (d = 0.8 and d = 2.24, respectively).","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'de-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena Street, Seville, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Barrera-García-Martín', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena Street, Seville, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Science, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13040']
572,31837050,Efficacy of SM-1 in a transient insomnia model.,"OBJECTIVES


The objectives of this study were primarily to assess the efficacy and safety of SM-1 in a circadian challenge model of transient insomnia and secondarily, to assess the contribution of diphenhydramine to the combination.
METHODS


Randomized, double-blind, placebo-controlled three-way cross-over study with a 5-hr phase advance. Subjects were 39 healthy adults reporting a history of transient insomnia. All treatments (SM-1, SM-1 without diphenhydramine, or placebo) were administered to all subjects in a randomly assigned sequence, with at least 1 week between treatments. The primary endpoint was total sleep time (TST) determined by polysomnography. Secondary endpoints included wakefulness after sleep onset (WASO), latency to persistent sleep, number of awakenings (NAW), subjective TST (sTST) and sleep latency (sSL), TST, and NAW by quarters of the night and sleep quality. Safety endpoints included adverse events, Karolinska Sleepiness Scale digit symbol substitution test, and subject-reported alertness level.
RESULTS


SM-1 provided an increase of 126.7 min in TST over placebo (p < .001). WASO, sTST, sleep quality, and sSL also showed significant improvement. Diphenhydramine demonstrated a significant (p = .014) contribution of 43.7 min to TST. SM-1 was well-tolerated with type and frequency of adverse events comparable with placebo, and no residual sleepiness upon awakening after 8 hr.
CONCLUSIONS


SM-1 provided a robust and statistically significant increase in TST compared with placebo in a circadian model of transient insomnia, without evidence of next-day impairment. Diphenhydramine contributed to the effect.",2019,"RESULTS


SM-1 provided an increase of 126.7 min in TST over placebo (p < .001).",['Subjects were 39 healthy adults reporting a history of transient insomnia'],"['diphenhydramine, or placebo', 'SM-1', 'placebo', 'diphenhydramine', 'Diphenhydramine']","['adverse events, Karolinska Sleepiness Scale digit symbol substitution test, and subject-reported alertness level', 'TST', 'WASO, sTST, sleep quality, and sSL', 'total sleep time (TST', 'wakefulness after sleep onset (WASO), latency to persistent sleep, number of awakenings (NAW), subjective TST (sTST) and sleep latency (sSL), TST, and NAW by quarters of the night and sleep quality']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0393759', 'cui_str': 'Transient Insomnia'}]","[{'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}]",39.0,0.262737,"RESULTS


SM-1 provided an increase of 126.7 min in TST over placebo (p < .001).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dahl', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Lan Bo', 'Initials': 'LB', 'LastName': 'Chen', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, New York.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Sleep Disorders and Research, Henry Ford Hospital Sleep Disorders Center, Detroit, Michigan.'}]",Human psychopharmacology,['10.1002/hup.2713']
573,31900843,"Effects of montelukast sodium plus budesonide on lung function, inflammatory factors, and immune levels in elderly patients with asthma.","BACKGROUND


Asthma in elderly patients causes excessive suffering and inconvenience. Regimens with better efficacy and less adverse events are still in need of researches.
AIMS


To investigate the effect of montelukast sodium plus budesonide on lung function, inflammatory factors, and immune levels in elderly asthma patients.
METHODS


A total of 180 patients with asthma were assigned into the control group and the observation group. The control group was given aerosol inhalation of budesonide suspension, while the observation group was given budesonide inhalation and oral montelukast sodium. The treatment effect, lung function (forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF)%), inflammatory factors (interleukin (IL)-4, IL-6, and tumor necrosis factor-α (TNF-α)), and immune level (immunoglobulin (Ig) A, and IgE) were analyzed and compared between the two groups.
RESULTS


After treatment, the effective rate was significantly higher in the observation group. The lung function and serum inflammatory factors were improved in both groups. The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower. Patients in both groups showed elevated IgA level and reduced IgE level, and the improvements were more significant in the observation group. There was no significant difference between the two groups in terms of adverse reaction.
CONCLUSIONS


Montelukast sodium plus budesonide has a promising clinical effect on asthma in elderly patients, effectively improves lung function and immunocompetence, and controls inflammatory response, without increasing the adverse reaction.",2020,"The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower.","['180 patients with asthma', 'elderly patients', 'elderly asthma patients', 'elderly patients with asthma', 'elderly patients causes excessive suffering and inconvenience']","['aerosol inhalation of budesonide suspension', 'budesonide inhalation and oral montelukast sodium', 'Montelukast sodium plus budesonide', 'montelukast sodium plus budesonide']","['FEV1, FVC, and PEF', 'elevated IgA level and reduced IgE level', 'lung function, inflammatory factors, and immune levels', 'adverse reaction', 'inflammatory factors IL-4, IL-6, and TNF-α', 'effective rate', 'lung function (forced expiratory volume in 1\xa0s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF)%), inflammatory factors (interleukin (IL)-4, IL-6, and tumor necrosis factor-α (TNF-α)), and immune level (immunoglobulin (Ig) A, and IgE', 'lung function and serum inflammatory factors', 'lung function and immunocompetence, and controls inflammatory response']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0380447', 'cui_str': 'montelukast sodium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020987', 'cui_str': 'Immunologic Competence'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",180.0,0.0356722,"The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory, Zhangye People's Hospital Affiliated to Hexi University, Zhangye, 734000, Gansu, China.""}, {'ForeName': 'Baohong', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory, Zhangye People's Hospital Affiliated to Hexi University, Zhangye, 734000, Gansu, China. libaohong2lb3h@163.com.""}]",Irish journal of medical science,['10.1007/s11845-019-02167-5']
574,31170680,Time to treatment response of a magnesium- and sulphate-rich natural mineral water in functional constipation.,"OBJECTIVES


First-line recommendations for the management of functional constipation include nutritional-hygienic measures. We previously showed that a natural mineral water rich in sulphates and magnesium (Hépar) is efficient in the treatment of functional constipation. The aim of this study was to consolidate those first results and determine a precise time to respond to Hépar.
METHODS


This multicenter, randomized, double-blind, controlled study of the effect of Hépar on stool consistency and frequency in functional constipation included 226 outpatients. After washout, patients used 1.5 L of water daily, including 1 L of Hépar or of low-mineral water, during 14 d. In addition to a daily reporting of stool consistency by the patient, an expert investigator blindly analyzed stool consistency (Bristol stool scale) based on photographs taken by the patient.
RESULTS


The primary endpoint was met. Treatment response was more frequent in the Hépar arm than in the control group at day 14 (50% versus 29%, respectively; P = 0.001). Mean time to treatment response was shorter in the Hépar group (6.4 d) than in the control arm (7.3 d; P = 0.013). Concomitant stool scoring was available for 60% of the patients. Scores given to 79% of the stools were similar between the patient and the expert (differences ≤1). Safety analyses showed excellent results.
CONCLUSION


This study confirms the efficacy and safety of Hépar in the treatment of functional constipation and shows that it is associated with a response within 7 d. Hépar could be a safe response to the current absence of first-line medication in the treatment of functional constipation.",2019,Scores given to 79% of the stools were similar between the patient and the expert (differences ≤1).,"['functional constipation', 'functional constipation included 226 outpatients']","['natural mineral water rich in sulphates and magnesium (Hépar', 'Hépar', 'magnesium- and sulphate-rich natural mineral water']","['Mean time to treatment response', 'Concomitant stool scoring']","[{'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",226.0,0.0544011,Scores given to 79% of the stools were similar between the patient and the expert (differences ≤1).,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dupont', 'Affiliation': ""Service d'Explorations Fonctionnelles Digestives Pédiatriques, AP-HP, Hôpital Necker Enfant Malade, Université Paris Descartes, Paris, France. Electronic address: Christophe.dupont@nck.aphp.fr.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Constant', 'Affiliation': 'Nestlé Waters M.T., Issy-les-Moulineaux, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Imbert', 'Affiliation': 'Nestlé Waters M.T., Issy-les-Moulineaux, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Hébert', 'Affiliation': 'SC Partners, Paris, France.'}, {'ForeName': 'Othar', 'Initials': 'O', 'LastName': 'Zourabichvili', 'Affiliation': 'Quanta Medical, Rueil-Malmaison, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Kapel', 'Affiliation': 'Laboratoire de Coprologie Fonctionnelle, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, APHP, Paris, France.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.02.018']
575,31874050,"Effect of high-dose vitamin D supplementation in combination with weight loss diet on glucose homeostasis, insulin resistance, and matrix metalloproteinases in obese subjects with vitamin D deficiency: a double-blind, placebo-controlled, randomized clinical trial.","As there is limited and inconsistent evidence in potential role of vitamin D on insulin resistance and matrix metalloproteinases, this study aimed to examine the effect of vitamin D supplementation on glucose homeostasis, insulin resistance, and matrix metalloproteinases in obese subjects with vitamin D deficiency. A total of 44 participants with serum 25-hydroxyvitamin D (25(OH)D) level ≤ 50 nmol/L and body mass index (BMI) 30-40 kg / m 2  were randomly allocated into receiving weight reduction diet with either 50 000 IU vitamin D 3  pearl ( n  = 22) or placebo ( n  = 22) once weekly for 12 weeks. Primary outcomes were changes in fasting serum glucose (FSG), homeostasis model assessment of insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), and matrix metalloproteinases (MMPs). Secondary outcomes were changes in weight, BMI, 25(OH)D, calcium, phosphorous and parathyroid hormone (PTH). Sun exposure and dietary intakes were also assessed. Serum levels of 25(OH)D3 increased significantly with a simultaneous decrease in serum concentration of PTH in the vitamin D group. Weight, BMI, FSG, and MMP-9 decreased significantly in both groups, and there were significant differences in changes in weight, serum 25(OH)D3, PTH, and MMP-9 levels between the groups. Within- and between-groups analysis revealed no significant differences in serum calcium, phosphorous, serum insulin, HOMA-IR, QUICKI, and MMP-2 after intervention. Our results indicated that improvement in vitamin D status resulted in greater reductions in weight and MMP-9 during weight loss. These preliminary results are sufficient to warrant a bigger study group.",2019,Serum levels of 25(OH) D3 increased significantly with a simultaneous decrease in serum concentration of PTH in vitamin D group.,"['44 participants with serum 25(OH)D level ≤ 50 nmol/L and body mass index (BMI) 30-40 kg/m2', 'obese subjects with vitamin D deficiency']","['vitamin D supplementation', 'vitamin D', 'placebo', 'weight reduction diet with either 50000 IU vitamin D3 pearl (n = 22) or placebo']","['serum calcium, phosphorous, serum insulin, HOMA-IR, QUICKI and MMP-2', 'serum concentration of PTH', 'changes in weight, body mass index (BMI), 25(OH) D, calcium, phosphorous and Parathyroid hormone (PTH', 'weight and MMP-9 during weight loss', 'changes in fasting serum glucose (FSG), homeostasis model assessment insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI) and matrix metalloproteinases (MMPs', 'Serum levels of 25(OH) D3', 'weight, serum 25(OH) D3, PTH and MMP-9 levels', 'Sun exposure and dietary intakes', 'Glucose homeostasis, insulin resistance and matrix metalloproteinases', 'glucose homeostasis, insulin resistance and matrix metalloproteinases', 'vitamin D status', 'Weight, BMI, FSG and MMP-9']","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012167', 'cui_str': 'Weight Reduction Diet'}, {'cui': 'C4319613', 'cui_str': '50000'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",44.0,0.0960987,Serum levels of 25(OH) D3 increased significantly with a simultaneous decrease in serum concentration of PTH in vitamin D group.,"[{'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Aliashrafi', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehrangiz', 'Initials': 'M', 'LastName': 'Ebrahimi-Mameghani', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Sciences, Tabriz University of Medical science, Tabriz, Iran.'}, {'ForeName': 'Mohammad Asghari', 'Initials': 'MA', 'LastName': 'Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Lotfi-Dizaji', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Vaghef-Mehrabany', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed-Rafie', 'Initials': 'SR', 'LastName': 'Arefhosseini', 'Affiliation': 'Nutritional Biochemistry, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2018-0773']
576,31839279,"Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial.","BACKGROUND


Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups.
METHODS


We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921.
FINDINGS


Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95% BCrI 1·00-5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group.
INTERPRETATION


Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner.
FUNDING


European Commission's Seventh Framework Programme.",2020,"Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72.","['patients with influenza-like illness', '36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model', '3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93', 'Between Jan 15, 2016, and April 12, 2018', 'patients aged 1 year and older presenting with influenza-like illness in primary care', 'Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner', 'primary care', '3059 participants had PCR-confirmed influenza infection', 'Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone']","['oseltamivir', 'Oseltamivir plus usual care versus usual care']","['burden of vomiting or nausea', 'Time to recovery', 'time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",3059.0,0.251885,"Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72.","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Department of Primary Care Health Services, University of Oxford, Oxford, UK. Electronic address: christopher.butler@phc.ox.ac.uk.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Department of Primary Care Health Services, University of Oxford, Oxford, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants, Austin, Texas; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Centre for General Practice, Department of Primary and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Department of Primary Care Health Services, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, CA, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Berry Consultants, Austin, TX, USA.'}, {'ForeName': 'Maciek', 'Initials': 'M', 'LastName': 'Godycki-Cwirko', 'Affiliation': 'Centre for Family and Community Medicine, Faculty of Health Sciences, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Chlabicz', 'Affiliation': 'Department of Family Medicine, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Lionis', 'Affiliation': 'Clinic of Social and Family Medicine, Faculty of Medicine, University of Crete, Crete, Greece.'}, {'ForeName': 'Bohumil', 'Initials': 'B', 'LastName': 'Seifert', 'Affiliation': 'Department of General Practice, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Pär-Daniel', 'Initials': 'PD', 'LastName': 'Sundvall', 'Affiliation': 'Research and Development Primary Health Care-Region Västra Götaland, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Colliers', 'Affiliation': 'Centre for General Practice, Department of Primary and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Aabenhus', 'Affiliation': 'Section and Research Unit of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'Section and Research Unit of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Jonassen Harbin', 'Affiliation': 'Antibiotic Center for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindbæk', 'Affiliation': 'Antibiotic Center for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Glinz', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Bernadett', 'Initials': 'B', 'LastName': 'Kovács', 'Affiliation': 'Drug Research Centre, Balatonfüred, Hungary.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Radzeviciene Jurgute', 'Affiliation': 'JSC Mano seimos gydytojas (My family doctor), Klaipeda, Lithuania.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Touboul Lundgren', 'Affiliation': ""Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Murphy', 'Affiliation': 'Health Research Board Primary Care Clinical Trial Network Ireland, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'De Sutter', 'Affiliation': 'Center for Family Medicine UGent, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Openshaw', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Menno D', 'Initials': 'MD', 'LastName': 'de Jong', 'Affiliation': 'Department of Medical Microbiology, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': 'ConfluenceStat, Orlando, FL, USA; College of Medicine, University of Central Florida, Orlando, FL, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Matheeussen', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Ieven', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)32982-4']
577,31866328,"Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial.","BACKGROUND


Treatment of ventilated pneumonia is often unsuccessful, even when patients are treated according to established guidelines. Therefore, we aimed to investigate the efficacy of the combination drug device Amikacin Inhale as an adjunctive therapy to intravenous standard-of-care antibiotics for pneumonia caused by Gram-negative pathogens in intubated and mechanically ventilated patients.
METHODS


INHALE was a prospective, double-blind, randomised, placebo-controlled, phase 3 study comprising two trials (INHALE 1 and INHALE 2) done in 153 hospital intensive-care units in 25 countries. Eligible patients were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was documented as being caused by or showing two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6. Patients were stratified by region and disease severity (according to their Acute Physiology and Chronic Health Evaluation [APACHE] II score) and randomly assigned (1:1) via an interactive voice-recognition system to receive 400 mg amikacin (Amikacin Inhale) or saline placebo, both of which were aerosolised, administered every 12 h for 10 days via the same synchronised inhalation system, and given alongside standard-of-care intravenous antibiotics. All patients and all staff involved in administering devices and monitoring outcomes were masked to treatment assignment. The primary endpoint, survival at days 28-32, was analysed in all patients who received at least one dose of study drug, were infected with a Gram-negative pathogen, and had an APACHE II score of at least 10 at diagnosis. Safety analyses were done in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, numbers NCT01799993 and NCT00805168.
FINDINGS


Between April 13, 2013, and April 7, 2017, 807 patients were assessed for eligibility and 725 were randomly assigned to Amikacin Inhale (362 patients) or aerosolised placebo (363 patients). 712 patients received at least one dose of study drug (354 in the Amikacin Inhale group and 358 in the placebo group), although one patient assigned to Amikacin Inhale received placebo in error and was included in the placebo group for safety analyses. 508 patients (255 in the Amikacin Inhale group and 253 in the placebo group) were assessed for the primary endpoint. We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43). Similar proportions of patients in the two treatment groups had a treatment-emergent adverse event (295 [84%] of 353 patients in the Amikacin Inhale group vs 303 [84%] of 359 patients in the placebo group) or a serious treatment-emergent adverse event (101 [29%] patients vs 97 [27%] patients).
INTERPRETATION


Our findings do not support use of inhaled amikacin adjunctive to standard-of-care intravenous therapy in mechanically ventilated patients with Gram-negative pneumonia.
FUNDING


Bayer AG.",2020,"We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43).","['153 hospital intensive-care units in 25 countries', 'mechanically ventilated patients with Gram-negative pneumonia (INHALE', 'Eligible patients were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was documented as being caused by or showing two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6', 'Between April 13, 2013, and April 7, 2017, 807 patients were assessed for eligibility and 725 were randomly assigned to', '508 patients (255 in the Amikacin Inhale group and 253 in the', 'intubated and mechanically ventilated patients', 'mechanically ventilated patients with Gram-negative pneumonia', 'Patients were stratified by region and disease severity (according to their Acute Physiology and Chronic Health Evaluation [APACHE] II score) and randomly assigned (1:1) via an', '363 patients', '712 patients received at least one dose of study drug (354 in the Amikacin Inhale group and 358 in the']","['amikacin adjunctive to intravenous standard-of-care antibiotics', 'placebo', 'Amikacin Inhale received placebo', 'amikacin adjunctive', 'aerosolised placebo', 'interactive voice-recognition system to receive 400 mg amikacin (Amikacin Inhale) or saline placebo', 'Amikacin']","['survival', 'serious treatment-emergent adverse event', 'treatment-emergent adverse event']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0854248', 'cui_str': 'Pneumonia caused by Gram negative bacteria (disorder)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",807.0,0.74974,"We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43).","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Niederman', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, New York Presbyterian/Weill Cornell Medical Center, New York, NY, USA. Electronic address: msn9004@med.cornell.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Alder', 'Affiliation': 'Anti-Infective Consulting, Margaretville, NY, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bassetti', 'Affiliation': 'Infectious Diseases Clinic, Department of Health Sciences, University of Genoa and Policlinico San Martino Hospital, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Boateng', 'Affiliation': 'Bayer Healthcare Inc, Whippany, NJ, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Corkery', 'Affiliation': 'Novartis Pharmaceuticals, San Carlos, CA, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Dhand', 'Affiliation': 'Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lawatscheck', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McLeroth', 'Affiliation': 'Covance, Princeton, NJ, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Nicolau', 'Affiliation': 'Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'G Christopher', 'Initials': 'GC', 'LastName': 'Wood', 'Affiliation': 'Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, University of Tennessee, Memphis, TN, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Chastre', 'Affiliation': 'Intensive Care Unit, Sorbonne University Hospitals, Paris, France.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30574-2']
578,30910420,Exercise and Cognitive Training as a Strategy to Improve Neurocognitive Outcomes in Heart Failure: A Pilot Study.,"OBJECTIVE


Mild cognitive impairment, especially memory loss, is prevalent in patients with heart failure (HF) and contributes to poor clinical outcomes and higher mortality.
METHODS


This study evaluated a combined aerobic exercise and cognitive training (EX/CT) program on memory, executive function, attention, processing speed and reaction time compared to exercise only or a usual care attention control (UCAC) stretching and flexibility program. Participants completed a standardized neurocognitive battery at baseline, 3 months, and 6 months along with demographic, clinical, and functional capacity (6-minute walk test). A linear mixed model analysis was used with comorbidity as a covariate.
RESULTS


Sixty-nine participants were enrolled, the mean age was 61 ± 10 years, 54% were women, 55% were African American, and the mean left ventricular ejection fraction percentage was 35 ± 15. A significant group by time interaction for verbal memory was found at 3 months (F [2, 53] = 4.3, p = 0.018) but was not sustained at 6 months in the EX/CT group. Processing speed/attention differed across treatment groups between baseline and 6 months, but improvement occurred among UCAC participants. There were also significant group differences in the 6MWT distance occurring at 3 months (F [2, 52] = 3.5, p = 0.036); however, significant improvement was observed within the EX/CT group only. There were no significant differences in 6MWT in the other groups at 3 or 6 months.
CONCLUSION


An EX/CT intervention was associated with improved memory in persons with HF and warrants further investigation in a larger trial. The relationship between functional capacity and cognitive function also needs further study.",2019,"There were also significant group differences in the 6MWT distance occurring at 3 months (F [2, 52] = 3.5, p = 0.036); however, significant improvement was observed within the EX/CT group only.","['Heart Failure', 'patients with heart failure (HF', 'Sixty-nine participants were enrolled, the mean age was 61 ± 10years, 54% were women, 55% were African American, and the mean left ventricular ejection fraction percentage was 35 ± 15']","['EX/CT intervention', 'exercise only or a usual care attention control (UCAC) stretching and flexibility program', 'Exercise and Cognitive Training', 'combined aerobic exercise and cognitive training (EX/CT) program']","['Neurocognitive Outcomes', 'Processing speed/attention', 'memory, executive function, attention, processing speed and reaction time', '6MWT distance', 'time interaction for verbal memory', '6MWT']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",69.0,0.0488471,"There were also significant group differences in the 6MWT distance occurring at 3 months (F [2, 52] = 3.5, p = 0.036); however, significant improvement was observed within the EX/CT group only.","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Gary', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing (RAG, SP, EC, BB, KH, BW, DWV), Atlanta. Electronic address: ragary@emory.edu.'}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing (RAG, SP, EC, BB, KH, BW, DWV), Atlanta.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Corwin', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing (RAG, SP, EC, BB, KH, BW, DWV), Atlanta.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Butts', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing (RAG, SP, EC, BB, KH, BW, DWV), Atlanta.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Emory University School of Medicine (AHM), Winship Cancer Institute, Atlanta.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hepburn', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing (RAG, SP, EC, BB, KH, BW, DWV), Atlanta.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing (RAG, SP, EC, BB, KH, BW, DWV), Atlanta.'}, {'ForeName': 'Drenna', 'Initials': 'D', 'LastName': 'Waldrop-Valverde', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing (RAG, SP, EC, BB, KH, BW, DWV), Atlanta.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.01.211']
579,31029921,The effect of single-nucleotide polymorphisms at the ADIPOQ gene locus rs1501299 on metabolic parameters after 9 mo of a high-protein/low-carbohydrate versus a standard hypocaloric diet.,"OBJECTIVE


Some adiponectin gene (ADIPOQ) single-nucleotide polymorphisms (SNPs) have been related to basal and adiponectin levels and metabolic parameters. The aim of this study was to evaluate the effect of the genetic variant rs1501299 ADIPOQ gene on biochemical changes after weight loss secondary to a high-protein and low-carbohydrate diet versus a standard severe hypocaloric diet over 9 mo as the primary endpoint.
METHODS


A white population of 270 obese patients was enrolled in a randomized clinical trial with two hypocaloric diets (high-protein and low carbohydrate diet [HP] versus standard diet [S]) over 9 mo of intervention. The statistical analysis was performed for the combined GT and TT as a group (T-allele carriers) and GG as second group (non-T-allele carriers). Before and after 12 wk on each hypocaloric diet, an anthropometric evaluation, an assessment of nutritional intake, and a biochemical analysis were realized.
RESULTS


With both dietary interventions, body weight, body mass index (BMI), fat mass, waist circumference, systolic blood pressure, and leptin levels decreased. In non-T-allele carriers after both diets, the decrease in total cholesterol levels -12.3 ± 2.2 mg/dL (T-allele carriers -6.9 ± 2.1 mg/dL; P = 0.01 diet HP) and 12.2 ± 3.1 mg/dL (T-allele carriers -4.7 ± 1.2 mg/dL; P = 0.02 after diet S), low-density lipoprotein cholesterol -13.2 ± 2.7 mg/dL (T-allele carriers -6.1 ± 2.1 mg/dL; P = 0.02 after diet HP) and -9.3 ± 1.8 mg/dL (T-allele carriers -4.8 ± 2.9 mg/dL; P = 0.01 after diet S), triacylglycerol levels -12.7 ± 6.1 mg/dL (T-allele carriers -6 ± 2.9 mg/dL; P = 0.01 after diet HP) and -16.3 ± 7.2 mg/dL (T-allele carriers -5.3 ± 1.4 mg/dL; P = 0.03 after diet S), insulin levels -5 ± 1.1 mUI/L (in T-allele -1.7 ± 0.9 mUI/L; P = 0.02 after diet HP) and -3.2 1.1 mUI/L (T-allele carriers -0.7 ± 0.7 mUI/L; P = 0.02 after diet S), and homeostatic model assessment of insulin resistance levels -0.4 ± 0.2 units (T-allele group -0.1 ± 0.1; P = 0.04 after diet HP) and -0.7 ± 0.1 units (T-allele carriers -0.1 ± 0.5 mg/dL; P = 0.01 after diet S) was higher than T-allele carriers. Only no T-allele carriers showed an increase in adiponectin levels after both diets.
CONCLUSION


After two different hypocaloric diets during 9 mo of intervention, the GG genotype of an ADIPOQ gene variant (rs1501299) is related to better improvement in adiponectin levels, insulin resistance, and lipid profile than T-allele carriers.",2019,"In non-T-allele carriers after both diets, the decrease in total cholesterol levels -12.3 ± 2.2 mg/dL (T-allele carriers -6.9 ± 2.1 mg/dL; P = 0.01 diet HP) and 12.2 ± 3.1 mg/dL",['A white population of 270 obese patients'],"['dL', 'hypocaloric diets (high-protein and low carbohydrate diet [HP] versus standard diet [S']","['body weight, body mass index (BMI), fat mass, waist circumference, systolic blood pressure, and leptin levels', 'adiponectin levels, insulin resistance, and lipid profile', 'adiponectin levels', 'total cholesterol levels']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}]",270.0,0.0245132,"In non-T-allele carriers after both diets, the decrease in total cholesterol levels -12.3 ± 2.2 mg/dL (T-allele carriers -6.9 ± 2.1 mg/dL; P = 0.01 diet HP) and 12.2 ± 3.1 mg/dL","[{'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'Daniel Antonio', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. Electronic address: Dadluis@yahoo.es.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.02.012']
580,31844886,"Safety and efficacy of VB-111, an anticancer gene therapy, in patients with recurrent glioblastoma: results of a phase I/II study.","BACKGROUND


VB-111 is a non-replicating adenovirus carrying a Fas-chimera transgene, leading to targeted apoptosis of tumor vascular endothelium and induction of a tumor-specific immune response. This phase I/II study evaluated the safety, tolerability, and efficacy of VB-111 with and without bevacizumab in recurrent glioblastoma (rGBM).
METHODS


Patients with rGBM (n = 72) received VB-111 in 4 treatment groups: subtherapeutic (VB-111 dose escalation), limited exposure (LE; VB-111 monotherapy until progression), primed combination (VB-111 monotherapy continued upon progression with combination of bevacizumab), and unprimed combination (upfront combination of VB-111 and bevacizumab). The primary endpoint was median overall survival (OS). Secondary endpoints were safety, overall response rate, and progression-free survival (PFS).
RESULTS


VB-111 was well tolerated. The most common adverse event was transient mild-moderate fever. Median OS time was significantly longer in the primed combination group compared with both LE (414 vs 223 days; hazard ratio [HR], 0.48; P = 0.043) and unprimed combination (414 vs 141.5 days; HR, 0.24; P = 0.0056). Patients in the combination phase of the primed combination group had a median PFS time of 90 days compared with 60 in the LE group (HR, 0.36; P = 0.032), and 63 in the unprimed combination group (P = 0.72). Radiographic responders to VB-111 exhibited characteristic, expansive areas of necrosis in the areas of initial enhancing disease.
CONCLUSIONS


Patients with rGBM who were primed with VB-111 monotherapy that continued after progression with the addition of bevacizumab showed significant survival and PFS advantage, as well as specific imaging characteristics related to VB-111 mechanism of action. These results warrant further assessment in a randomized controlled study.",2020,"Median OS time was significantly longer in the Primed Combination group compared to both LE (414 vs 223 days; HR 0.48; p=0.043), and Unprimed Combination (414 vs. 141.5 days; HR 0.24; p=0.0056); Patients in the combination phase of the Primed Combination group had a median PFS time of 90 days compared to 60 in the LE group (HR 0.36; p=0.032), and 63 in the Unprimed Combination group (p=0.72).","['patients with recurrent glioblastoma', 'Patients with rGBM', 'Patients with rGBM (n=72) received', 'recurrent glioblastoma (rGBM']","['bevacizumab', 'VB-111', 'Unprimed Combination (upfront combination of VB-111 and bevacizumab', 'Sub-Therapeutic (VB-111 dose escalation), Limited Exposure (LE, VB-111 monotherapy until progression), Primed Combination ', 'VB-111 with and without bevacizumab']","['median PFS time', 'safety, tolerability and efficacy', 'Median OS time', 'median overall survival (OS', 'safety, overall response rate, and progression-free survival (PFS', 'tolerated', 'survival and PFS advantage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0889918,"Median OS time was significantly longer in the Primed Combination group compared to both LE (414 vs 223 days; HR 0.48; p=0.043), and Unprimed Combination (414 vs. 141.5 days; HR 0.24; p=0.0056); Patients in the combination phase of the Primed Combination group had a median PFS time of 90 days compared to 60 in the LE group (HR 0.36; p=0.032), and 63 in the Unprimed Combination group (p=0.72).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Mays Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Peters', 'Affiliation': 'Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Vredenburgh', 'Affiliation': 'Saint Francis Hospital and Medical Center, Hartford, Connecticut, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bokstein', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Deborah T', 'Initials': 'DT', 'LastName': 'Blumenthal', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Yust-Katz', 'Affiliation': 'Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petach Tikvah, Israel and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Peretz', 'Affiliation': 'Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petach Tikvah, Israel and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Oberman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, Ronald Reagan UCLA Medical Center, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Naamit', 'Initials': 'N', 'LastName': 'Sher', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Niva', 'Initials': 'N', 'LastName': 'Yakov', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Itzhak', 'Initials': 'I', 'LastName': 'Mendel', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Breitbart', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz231']
581,31844890,A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE).,"BACKGROUND


Ofranergene obadenovec (VB-111) is an anticancer viral therapy that demonstrated in a phase II study a survival benefit for patients with recurrent glioblastoma (rGBM) who were primed with VB-111 monotherapy that was continued after progression with concomitant bevacizumab.
METHODS


This pivotal phase III randomized, controlled trial compared the efficacy and safety of upfront combination of VB-111 and bevacizumab versus bevacizumab monotherapy. Patients were randomized 1:1 to receive VB-111 1013 viral particles every 8 weeks in combination with bevacizumab 10 mg/kg every 2 weeks (combination arm) or bevacizumab monotherapy (control arm). The primary endpoint was overall survival (OS), and secondary endpoints were objective response rate (ORR) by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS).
RESULTS


Enrolled were 256 patients at 57 sites. Median exposure to VB-111 was 4 months. The study did not meet its primary or secondary goals. Median OS was 6.8 versus 7.9 months in the combination versus control arm (hazard ratio, 1.20; 95% CI: 0.91-1.59; P = 0.19) and ORR was 27.3% versus 21.9% (P = 0.26). A higher rate of grades 3-5 adverse events was reported in the combination arm (67% vs 40%), mainly attributed to a higher rate of CNS and flu-like/fever events. Trends for improved survival with combination treatment were seen in the subgroup of patients with smaller tumors and in patients who had a posttreatment febrile reaction.
CONCLUSIONS


In this study, upfront concomitant administration of VB-111 and bevacizumab failed to improve outcomes in rGBM. Change of treatment regimen, with the lack of VB-111 monotherapy priming, may explain the differences from the favorable phase II results.
CLINICAL TRIALS REGISTRATION


NCT02511405.",2020,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"['patients with recurrent glioblastoma (rGBM', 'patients with recurrent glioblastoma (GLOBE', '256 patients were enrolled at 57 sites']","['bevacizumab', 'VB-111 and bevacizumab versus bevacizumab monotherapy', 'VB-111 1013 viral particles q8W in combination with bevacizumab 10mg/Kg q2W (combination arm) or bevacizumab monotherapy (control arm', 'VB-111 and bevacizumab', 'VB-111 combined with bevacizumab vs. bevacizumab monotherapy']","['survival', 'rate of CNS and flu-like/fever events', 'overall survival (OS', 'objective response rate (ORR) by RANO and Progression Free Survival (PFS', 'efficacy and safety', 'ORR', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",256.0,0.111146,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Butowski', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Leor', 'Initials': 'L', 'LastName': 'Zach', 'Affiliation': 'Oncology Institute, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Jian L', 'Initials': 'JL', 'LastName': 'Campian', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Fain Shmueli', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz232']
582,31887792,The Effect of Stereoscopic Augmented Reality Visualization on Learning Anatomy and the Modifying Effect of Visual-Spatial Abilities: A Double-Center Randomized Controlled Trial.,"Monoscopically projected three-dimensional (3D) visualization technology may have significant disadvantages for students with lower visual-spatial abilities despite its overall effectiveness in teaching anatomy. Previous research suggests that stereopsis may facilitate a better comprehension of anatomical knowledge. This study evaluated the educational effectiveness of stereoscopic augmented reality (AR) visualization and the modifying effect of visual-spatial abilities on learning. In a double-center randomized controlled trial, first- and second-year (bio)medical undergraduates studied lower limb anatomy with stereoscopic 3D AR model (n = 20), monoscopic 3D desktop model (n = 20), or two-dimensional (2D) anatomical atlas (n = 18). Visual-spatial abilities were tested with Mental Rotation Test (MRT), Paper Folding Test (PFT), and Mechanical Reasoning (MR) Test. Anatomical knowledge was assessed by the validated 30-item paper posttest. The overall posttest scores in the stereoscopic 3D AR group (47.8%) were similar to those in the monoscopic 3D desktop group (38.5%; P = 0.240) and the 2D anatomical atlas group (50.9%; P = 1.00). When stratified by visual-spatial abilities test scores, students with lower MRT scores achieved higher posttest scores in the stereoscopic 3D AR group (49.2%) as compared to the monoscopic 3D desktop group (33.4%; P = 0.015) and similar to the scores in the 2D group (46.4%; P = 0.99). Participants with higher MRT scores performed equally well in all conditions. It is instrumental to consider an aptitude-treatment interaction caused by visual-spatial abilities when designing research into 3D learning. Further research is needed to identify contributing features and the most effective way of introducing this technology into current educational programs.",2020,The overall post-test scores in the stereoscopic 3D AR group (47.8 %) were similar to those in the monoscopic 3D desktop group (38.5 %; P = 0.081) and the 2D anatomical atlas group (50.9 %; P = 1.00).,[],"['stereoscopic augmented reality (AR) visualization', 'monoscopic 3D desktop model (n = 20) or two-dimensional (2D) anatomical atlas', 'stereoscopic 3D AR model', 'stereoscopic Augmented Reality visualization']","['MRT scores', 'Anatomical knowledge', 'visual-spatial abilities', 'Mental Rotation Test (MRT), Paper Folding Test and Mechanical Reasoning Test', 'overall post-test scores', 'Visual-spatial abilities']",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0585443,The overall post-test scores in the stereoscopic 3D AR group (47.8 %) were similar to those in the monoscopic 3D desktop group (38.5 %; P = 0.081) and the 2D anatomical atlas group (50.9 %; P = 1.00).,"[{'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bogomolova', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ineke J M', 'Initials': 'IJM', 'LastName': 'van der Ham', 'Affiliation': 'Department of Neuropsychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Mary E W', 'Initials': 'MEW', 'LastName': 'Dankbaar', 'Affiliation': 'Institute for Medical Education Research Rotterdam, Rotterdam Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'van den Broek', 'Affiliation': 'Institute for Medical Education Research Rotterdam, Rotterdam Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Steven E R', 'Initials': 'SER', 'LastName': 'Hovius', 'Affiliation': 'Department of Plastic and Reconstructive Surgery and Hand Surgery, Rotterdam Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jos A', 'Initials': 'JA', 'LastName': 'van der Hage', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Beerend P', 'Initials': 'BP', 'LastName': 'Hierck', 'Affiliation': 'Center for Innovation of Medical Education, Leiden University Medical Center, Leiden, The Netherlands.'}]",Anatomical sciences education,['10.1002/ase.1941']
583,31891407,Lack of effect of tart cherry concentrate dose on serum urate in people with gout.,"OBJECTIVES


Cherry concentrate has been suggested to reduce serum urate (SU) and gout flares. The aims of this study were to determine the magnitude of the effect of tart cherry concentrate on SU in people with gout, the most effective dose of tart cherry concentrate for lowering SU, and adverse effects.
METHODS


Fifty people with gout and SU > 0.36 mmol/l were recruited. Half were on allopurinol and half were on no urate-lowering therapy. Participants were randomized to receive tart cherry juice concentrate: placebo, 7.5 ml, 15 ml, 22.5 ml or 30 ml twice daily for 28 days. Blood samples were taken at baseline, then at 1, 3 and 5 h post cherry and then on days 1, 3, 7, 14, 21 and 28. The area under the curve for SU was calculated over the 28-day study period.
RESULTS


Cherry concentrate dose had no significant effect on reduction in SU area under the curve, urine urate excretion, change in urinary anthocyanin between day 0 and day 28, or frequency of gout flares over the 28-day study period (P = 0.76). There were 24 reported adverse events, with only one (hyperglycaemia) considered possibly to be related to cherry concentrate. Allopurinol use did not modify the effect of cherry on SU or urine urate excretion.
CONCLUSION


Tart cherry concentrate had no effect on SU or urine urate excretion. If there is an effect of cherry concentrate on gout flares over a longer time period, it is not likely to be mediated by reduction in SU.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR), https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368887, ANZCTR 12615000741583).",2020,"RESULTS


Cherry concentrate dose had no significant effect on reduction in SU area under the curve, urine urate excretion, change in urinary anthocyanin between day 0 and day 28, or frequency of gout flares over the 28-day study period (P = 0.76).","['people with gout', 'Fifty people with gout and SU\u2009>\u20090.36\u2009mmol/l were recruited']","['tart cherry juice concentrate: placebo', 'allopurinol', 'Allopurinol']","['gout flares', 'serum urate', 'frequency of gout flares', 'serum urate (SU) and gout flares', 'SU or urine urate excretion', 'adverse events', 'reduction in SU area under the curve, urine urate excretion, change in urinary anthocyanin']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C4517452', 'cui_str': '0.36'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C0982074', 'cui_str': 'CHERRY JUICE'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042037'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}]",50.0,0.340884,"RESULTS


Cherry concentrate dose had no significant effect on reduction in SU area under the curve, urine urate excretion, change in urinary anthocyanin between day 0 and day 28, or frequency of gout flares over the 28-day study period (P = 0.76).","[{'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Stamp', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chapman', 'Affiliation': 'Department of Rheumatology, Immunology and Allergy, Christchurch Hospital.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Duffull', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Drake', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Boston University School of Medicine, Boston, USA.'}, {'ForeName': 'Tuhina', 'Initials': 'T', 'LastName': 'Neogi', 'Affiliation': 'Boston University School of Medicine, Boston, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez606']
584,31201957,Differential plasma postprandial lipidomic responses to krill oil and fish oil supplementations in women: A randomized crossover study.,"OBJECTIVES


There is no convincing evidence that krill oil (KO) consumption results in a higher incorporation of long chain ω-3 polyunsaturated fatty acids into blood lipid fractions than fish oil (FO). This study examined the postprandial plasma lipidomic responses to KO supplementation compared with FO supplementation in healthy women.
METHODS


Ten women (aged 18-45 y) consumed a high-fat (15 g of olive oil) breakfast, supplemented with 5 g of KO or FO in a randomized crossover study with a minimum 7-d washout period between the supplementations. Plasma samples collected at the fasting state and at 3 and 5 h postprandially were analyzed using liquid chromatography electrospray ionization-tandem mass spectrometry.
RESULTS


After the supplementations, 5 out of 34 lipid classes or subclasses had significantly greater concentrations from KO compared with FO. There were 27 molecular species including 5 ether-phospholipid species, out of a total of 701, which had significant differences between supplementations in the postprandial period. Eicosapentaenoic acid and docosahexaenoic acid from KO were preferentially partitioned toward phospholipid molecular species, whereas eicosapentaenoic acid and docosahexaenoic acid from FO were preferentially partitioned toward neutral lipids.",2019,"After the supplementations, 5 out of 34 lipid classes or subclasses had significantly greater concentrations from KO compared with FO.","['Ten women (aged 18-45 y', 'healthy women', 'women']","['KO supplementation', 'high-fat (15 g of olive oil) breakfast, supplemented with 5 g of KO or FO', 'FO supplementation', 'krill oil and fish oil supplementations', 'krill oil (KO) consumption', 'Eicosapentaenoic acid and docosahexaenoic acid']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]",[],10.0,0.100056,"After the supplementations, 5 out of 34 lipid classes or subclasses had significantly greater concentrations from KO compared with FO.","[{'ForeName': 'Hyunsin H', 'Initials': 'HH', 'LastName': 'Sung', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, Victoria, Australia; Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Huynh', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Smith', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Mellett', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Meikle', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Xiao Q', 'Initials': 'XQ', 'LastName': 'Su', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Victoria, Australia. Electronic address: Xiao.su@vu.edu.au.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.03.021']
585,31321524,PEG vs. sennosides for opioid-induced constipation in cancer care.,"PURPOSE


This randomized double-blind, double-dummy, 2-treatment, 2-period crossover study aimed to compare the efficacy and tolerability of polyethylene glycol (PEG) and sennosides in ambulatory cancer patients with opioid-induced constipation.
METHODS


Outpatients ≥ 18 years old with cancer, at risk of or already experiencing opioid-induced constipation, were randomly assigned to begin a standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation. After 3 weeks, the patients switched to the alternate active product and dummy preparation. Constipation was assessed using the revised Victoria Bowel Performance Scale (rBPS) at the end of each of the 2 consecutive 21-day study periods for the number of days with a satisfactory bowel movement, the time in days to goal rBPS (G), and the treatment preference of each patient.
RESULTS


Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods. For the typical patient, the expected number of days with a satisfactory bowel movement per days of treatment was found to be 1.21 times higher on PEG than on sennosides in a particular period (95% credible interval 0.96 to 1.55). Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94). There was no evidence of a difference in patient preference between laxatives.
CONCLUSION


Our study found weak evidence that PEG is superior to sennosides with respect to overall effectiveness in cancer patients with opioid-induced constipation.",2020,Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94).,"['18\xa0years old with cancer, at risk of or already experiencing opioid-induced constipation', 'Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods', 'cancer patients with opioid-induced constipation', 'Outpatients ≥', 'ambulatory cancer patients with opioid-induced constipation']","['polyethylene glycol (PEG) and sennosides', 'standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation', 'PEG']","['revised Victoria Bowel Performance Scale (rBPS', 'Constipation', 'efficacy and tolerability', 'rBPS of G']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3160897'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C3489575', 'cui_str': 'sennosides, USP'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0222045'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",70.0,0.113312,Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94).,"[{'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Hawley', 'Affiliation': 'Pain and Symptom Management/Palliative Care, British Columbia Cancer, 600 W 10th Ave, Vancouver, BC, V5Z 4E6, Canada. phawley@bccancer.bc.ca.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'MacKenzie', 'Affiliation': 'University of British Columbia, 317 - 2194 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gobbo', 'Affiliation': 'Pain and Symptom Management/Palliative Care, British Columbia Cancer, 600 W 10th Ave, Vancouver, BC, V5Z 4E6, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04944-5']
586,31255174,Comparison of an interactive voice response system and smartphone application in the identification of gout flares.,"OBJECTIVE


To examine the feasibility, preference, and satisfaction of an interactive voice response (IVR) system versus a customized smartphone application (StudyBuddy) to capture gout flares METHODS: In this 24-week prospective, randomized, crossover, open-label pilot study, 44 gout patients were randomized to IVR vs. StudyBuddy and were crossed over to the other technology after 12 weeks. Flares were reported via weekly (and later daily) scheduled StudyBuddy or IVR queries. Feasibility was ascertained via response rate to scheduled queries. At 12 and 24 weeks, participants completed preference/satisfaction surveys. Preference and satisfaction were assessed using dichotomous or ordinal questions. Sensitivity was assessed by the frequency of flare reporting with each approach.
RESULTS


Thirty-eight of 44 participants completed the study. Among completers, feasibility was similar for IVR (81%) and StudyBuddy (80%). Conversely, most (74%) preferred StudyBuddy. Measures of satisfaction (ease of use, preference over in-person clinic visits, and willingness for future use) were similar between the IVR and StudyBuddy; however, more participants deemed the StudyBuddy as convenient (95% vs. 73%, P = 0.01) and less disruptive (97% vs. 82%, P = 0.03). Although the per patient number of weeks in flare was not significantly different (mean 3.4 vs. 2.6 weeks/patient, P = 0.15), the StudyBuddy captured more of the total flare weeks (35%) than IVR (27%, P = 0.02).
CONCLUSION


A smartphone application and IVR demonstrated similar feasibility but overall sensitivity to capture gout flares and participant preference were greater for the smartphone application. Participant preference for the smartphone application appeared to relate to perceptions of greater convenience and lower disruption.
TRIAL REGISTRATION


NCT, NCT02855437 . Registered 4 August 2016.",2019,A smartphone application and IVR demonstrated similar feasibility but overall sensitivity to capture gout flares and participant preference were greater for the smartphone application.,"['Thirty-eight of 44 participants completed the study', '44 gout patients']","['interactive voice response system and smartphone application', 'interactive voice response (IVR) system versus a customized smartphone application (StudyBuddy']","['Sensitivity', 'satisfaction (ease of use, preference over in-person clinic visits, and willingness for future use', 'Preference and satisfaction']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",44.0,0.0685999,A smartphone application and IVR demonstrated similar feasibility but overall sensitivity to capture gout flares and participant preference were greater for the smartphone application.,"[{'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Elmagboul', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Coburn', 'Affiliation': 'University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Mudano', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Melnick', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bergman', 'Affiliation': 'University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, USA.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Redden', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Cooper', 'Initials': 'C', 'LastName': 'Filby', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Ted R', 'Initials': 'TR', 'LastName': 'Mikuls', 'Affiliation': 'University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, USA.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA. ksaag@uabmc.edu.'}]",Arthritis research & therapy,['10.1186/s13075-019-1944-5']
587,31300303,Clinical randomized trial study of hearing aids effectiveness in association with Ginkgo biloba extract (EGb 761) on tinnitus improvement.,"INTRODUCTION


Tinnitus is defined as the perception of sound without its actual presence in the environment. It has been the subject of a great number of studies, especially considering its consequences on patient's quality of life.
OBJECTIVE


This study aimed to investigate the effect of hearing aids and/or Ginkgo biloba extract EGb 761 on tinnitus in patients with hearing loss.
METHODS


This is a trial randomized-controlled treatment, parallel, double-blind, with three-arm. Thirty-three adults subjects were divided into three groups: group 1 - subjects undergoing drug therapy with G. biloba extract EGb 761; group 2 - individuals fitted with digital hearing aids; group 3 - individuals submitted to drug therapy with G. biloba extract EGb 761 and using hearing aids. The tinnitus handicap inventory and visual analogue scale were used to evaluate self-perception of tinnitus loudness and severity before treatment and 90 days after treatment.
RESULTS


This study demonstrated a significant correlation between tinnitus handicap inventory and visual analogue scale, before and after treatment. We observed a significant improvement in self-perception of tinnitus loudness and severity after 90 days of treatment with G. biloba extract EGb 761 and/or hearing aids. No correlation was found between tinnitus onset time and self-perception of tinnitus loudness and severity. Hearing aids were more effective in patients with a shorter tinnitus onset time and G. biloba extract was effective regardless of tinnitus duration.
CONCLUSIONS


It was possible to prove the effectiveness of the hearing aids and/or G. biloba extract EGb 761 treatment, which shows success in the control of tinnitus contributing to the improvement of this symptom.",2019,"Hearing aids were more effective in patients with a shorter tinnitus onset time and G. biloba extract was effective regardless of tinnitus duration.
","['761 and/or hearing aids', 'Thirty-three adults subjects', 'patients with hearing loss']","['biloba extract EGb', 'Ginkgo biloba extract (EGb 761', 'drug therapy with G. biloba extract EGb 761; group 2 - individuals fitted with digital hearing aids; group 3 - individuals submitted to drug therapy with G. biloba extract EGb 761 and using hearing aids', 'biloba extract', 'hearing aids and/or Ginkgo biloba extract EGb']","['tinnitus onset time and self-perception of tinnitus loudness and severity', 'tinnitus handicap inventory and visual analogue scale', 'self-perception of tinnitus loudness and severity', 'tinnitus improvement']","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C1095795', 'cui_str': 'EGb 761'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",761.0,0.0590211,"Hearing aids were more effective in patients with a shorter tinnitus onset time and G. biloba extract was effective regardless of tinnitus duration.
","[{'ForeName': 'Camila L', 'Initials': 'CL', 'LastName': 'Radunz', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Cristina E', 'Initials': 'CE', 'LastName': 'Okuyama', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Fátima C A', 'Initials': 'FCA', 'LastName': 'Branco-Barreiro', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Fonoaudiologia, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Regina M S', 'Initials': 'RMS', 'LastName': 'Pereira', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia e Mestrado e Doutorado em Biotecnologia e Inovação em Saúde, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Susana N', 'Initials': 'SN', 'LastName': 'Diniz', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia e Mestrado e Doutorado em Biotecnologia e Inovação em Saúde, Sao Paulo, SP, Brazil. Electronic address: dinizsusana@gmail.com.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2019.05.003']
588,31308360,Development of a delayed-release nutrient for appetite control in adults with obesity and type 2 diabetes and initial clinical testing in a single dose randomized controlled trial.,"BACKGROUND AND OBJECTIVES


Delivery of nutrients directly to the small intestine, either via enteral feeding tube or by gastric bypass surgery, is associated with increased levels of appetite-suppressing and glucoregulatory hormones, including GLP-1, and reduced appetite. Achieving these changes non-invasively using formulated foods may be of therapeutic benefit in individuals with obesity and related comorbidities. The aim of this pilot study was to determine the effect of a single dose of a novel delayed-release nutrient (DRN) on glucose, GLP-1, c-peptide, insulin, and appetite in adults with obesity and type 2 diabetes.
SUBJECTS AND METHODS


We formulated an all-natural, generally recognized as safe ('GRAS"") DRN and conducted a randomized prospective crossover trial. Nineteen adults with obesity and type 2 diabetes underwent paired 3-h meal tolerance tests (MTT) in randomized order 1-4 weeks apart. Subjects ingested a single dose of DRN and the same nutrients as unformulated powders (UN).
RESULTS


For DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed. While Tmax for GLP-1 was also significantly delayed following DRN compared with UN (45 min later; p = 0.26), Cmax did not differ significantly. GLP-1 rose significantly during the last 90 min of the 3-h MTT (β 1  = 0.16 pg/mL/min, p = 0.025), while following UN it decreased (β 1  = -0.21 pg/mL/min, p = 0.0026) (p difference = 0.0003). There were minimal differences in seven measures of appetite and adverse symptoms between DRN and UN.
CONCLUSIONS


We conclude that nutrient can be formulated using all-natural ingredients to induce a delayed rise in GLP-1. Further testing is needed to determine the amount and site of nutrient release, when maximum GLP-1 levels occur, and if modification of the formulation specifications and dose are associated with appetite and glucose control.",2019,"RESULTS


For DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed.","['Nineteen adults with obesity and type 2 diabetes underwent', 'individuals with obesity and related comorbidities', 'adults with obesity and type 2 diabetes']","['novel delayed-release nutrient (DRN', 'paired 3-h meal tolerance tests (MTT']","['GLP-1', 'appetite and adverse symptoms', 'time of maximal concentration (Tmax', 'maximal concentration (Cmax', 'glucose, GLP-1, c-peptide, insulin, and appetite']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C4544674', 'cui_str': 'Delayed-release'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0647210', 'cui_str': 'MTTS'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",19.0,0.0759147,"RESULTS


For DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA. beale@usc.edu.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'SC CTSI, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yassine', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Azen', 'Affiliation': 'SC CTSI, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Christopher', 'Affiliation': 'CaliVive Inc., San Mateo, CA, 94402, USA.'}]",Nutrition & diabetes,['10.1038/s41387-019-0088-7']
589,31257067,Efficacy of a tailored PCR-guided triple therapy in the treatment of Helicobacter pylori infection.,"INTRODUCTION


Resistance to clarithromycin and fluoroquinolones is increasing in many countries. We aimed to assess the efficacy of a tailored PCR-guided triple therapy versus an empirical triple therapy in the treatment of H. pylori infection.
PATIENTS AND METHODS


French multicenter prospective open-label randomized study to assess H. pylori and resistance to clarithromycin and levofloxacin with GenoType HelicoDR® test. Patients of the control group were treated with empirical therapy of proton pump inhibitor (PPI), amoxicillin, and clarithromycin for 7 days. Patients of the experimental group with clarithromycin-susceptible strains, clarithromycin-resistant/levofloxacin-susceptible strains, and with clarithromycin-resistant/levofloxacin-resistant strains received tailored therapy of PPI, amoxicillin, and clarithromycin for 7 days, PPI, amoxicillin, and levofloxacin for 10 days, and PPI, amoxicillin, and metronidazole for 14 days, respectively. H. pylori eradication was assessed by  13 C urea breath test at least 28 days after the end of treatment.
RESULTS


We included 526 patients: 260 (49.4%) were randomly assigned to empirical triple therapy and 266 (50.6%) to tailored therapy. Clarithromycin and levofloxacin resistances were 23.3% and 12.8%, respectively. Follow-up urea breath test was available for 415 (78.9%) patients. Tailored therapy was superior to empirical therapy in terms of eradication (85.5% vs. 73.1%, RR=1.85, 95%CI [1.25-2.78], p=0.003). Findings were consistent in the susceptibility analysis using multiple imputation (RR=1.61, 95%CI [1.14-2.27], P=0.003) and per-protocol analysis (RR=1.89, 95%CI [0.25-2.78], p=0.003).
CONCLUSION


In a country with a high level of clarithromycin resistance, tailored PCR-guided therapy was superior to empirical triple therapy for H. pylori eradication (https://www.ClinicalTrials.gov: NCT01168063).",2020,"Tailored therapy was superior to empirical therapy in terms of eradication (85.5% vs. 73.1%, RR=1.85, 95%CI [1.25-2.78], p=0.003).",['526 patients: 260 (49.4'],"['clarithromycin and levofloxacin with GenoType HelicoDR ®  test', 'PPI, amoxicillin, and levofloxacin', 'PPI, amoxicillin, and clarithromycin', 'tailored PCR-guided triple therapy', 'empirical therapy of proton pump inhibitor (PPI), amoxicillin, and clarithromycin', 'Clarithromycin and levofloxacin', 'PPI, amoxicillin, and metronidazole', 'clarithromycin-susceptible strains, clarithromycin-resistant/levofloxacin-susceptible strains, and with clarithromycin-resistant/levofloxacin', 'clarithromycin and fluoroquinolones']","['Helicobacter pylori infection', 'H.\xa0pylori eradication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299597', 'cui_str': 'Empirical therapy (regime/therapy)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}]","[{'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",526.0,0.0899947,"Tailored therapy was superior to empirical therapy in terms of eradication (85.5% vs. 73.1%, RR=1.85, 95%CI [1.25-2.78], p=0.003).","[{'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Delchier', 'Affiliation': ""Inserm, centre d'investigation clinique 1430 et plateforme de ressources biologiques, département de gastroentérologie, université Paris Est Créteil (UPEC), hôpital Henri-Mondor, AP-HP, 94010 Créteil cedex, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bastuji-Garin', 'Affiliation': ""Service santé publique et unité de recherche clinique (URC-Mondor), hôpital Henri-Mondor, AP-HP, 94010 Créteil, France; LIC EA4393 (laboratoire d'investigation clinique), université Paris Est (UPE), 94010 Créteil, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'Laboratoire de bactériologie, université Paris VII, hôpital Cochin, AP-HP, 75014 Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Megraud', 'Affiliation': 'Laboratoire de bactériologie, Centre national de référence des campylobacter et helicobacter, université de Bordeaux, 33076 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Amiot', 'Affiliation': ""Inserm, centre d'investigation clinique 1430 et plateforme de ressources biologiques, département de gastroentérologie, université Paris Est Créteil (UPEC), hôpital Henri-Mondor, AP-HP, 94010 Créteil cedex, France. Electronic address: aurelien.amiot@aphp.fr.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cambau', 'Affiliation': 'UMR 1137 Inserm, service de bactériologie, université Paris Diderot, hôpitaux universitaires Lariboisière-Saint-Louis, AP-HP, 75010 Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Burucoa', 'Affiliation': 'EA 4331 LITEC, service de bactériologie-hygiène, faculté de médecine et de pharmacie, université de Poitiers, CHU de Poitiers, Poitiers, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medecine et maladies infectieuses,['10.1016/j.medmal.2019.06.001']
590,31290550,Long-Term Smoking Cessation Outcomes for Sexual Minority Versus Nonminority Smokers in a Large Randomized Controlled Trial of Two Web-Based Interventions.,"INTRODUCTION


Despite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments.
METHODS


Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization.
RESULTS


Cessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home.
CONCLUSIONS


Substantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers' willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions.
IMPLICATIONS


The findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers' willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.",2020,"At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home.
","['sexual minority (SM) and non-SM smokers', 'Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n=253; lesbian/gay, n=122; bisexual, n=131) or non-SM (n=2,384', 'sexual minority vs. non-minority smokers']",[],['complete-case self-reported 30-day abstinence'],"[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C1533642', 'cui_str': 'Women Who Have Sex With Women'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0278065,"At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home.
","[{'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly Group Health Research Institute), Seattle, WA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz112']
591,31202686,Resetting the late timing of 'night owls' has a positive impact on mental health and performance.,"BACKGROUND


There is conflict between living according to our endogenous biological rhythms and our external environment, with disruptions resulting in negative consequences to health and performance. This is often documented in shift work and jet lag, but 'societal norms' (eg, typical working hours) can create profound issues for 'night owls', people whose internal biological timing predisposes them to follow an unusually late sleep-wake cycle. Night owls have also been associated with health issues, mood disturbances, poorer performance and increased mortality rates.
METHODS


This study used a randomized control trial design aimed to shift the late timing of night owls to an earlier time (phase advance), using non-pharmacological, practical interventions in a real-world setting. These interventions targeted light exposure (through earlier wake up/sleep times), fixed meals times, caffeine intake and exercise.
RESULTS


Overall, participants demonstrated a significant advance of ∼2 h in sleep/wake timings as measured by actigraphy and circadian phase markers (dim light melatonin onset and peak time of the cortisol awakening response), whilst having no adverse effect on sleep duration. Notably, the phase advance was accompanied by significant improvements to self-reported depression and stress, as well as improved cognitive (reaction time) and physical (grip strength) performance measures during the typical 'suboptimal' morning hours.
CONCLUSIONS


Our findings propose a novel strategy for shifting clock timing towards a pattern that is more aligned to societal demands that could significantly improve elements of performance, mental health and sleep timing in the real world.",2019,"Notably, the phase advance was accompanied by significant improvements to self-reported depression and stress, as well as improved cognitive (reaction time) and physical (grip strength) performance measures during the typical 'suboptimal' morning hours.
",[],[],"['sleep duration', 'advance of ∼2\xa0h in sleep/wake timings as measured by actigraphy and circadian phase markers (dim light melatonin onset and peak time of the cortisol awakening response', 'improved cognitive (reaction time) and physical (grip strength) performance measures']",[],[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}]",,0.0311763,"Notably, the phase advance was accompanied by significant improvements to self-reported depression and stress, as well as improved cognitive (reaction time) and physical (grip strength) performance measures during the typical 'suboptimal' morning hours.
","[{'ForeName': 'Elise R', 'Initials': 'ER', 'LastName': 'Facer-Childs', 'Affiliation': 'School of Biosciences, University of Birmingham, Birmingham, B15 2TT, UK; Centre for Human Brain Health, University of Birmingham, Birmingham, B15 2TT, UK; School of Psychology, University of Birmingham, Birmingham, B15 2TT, UK. Electronic address: Elise.Facer-Childs@monash.edu.'}, {'ForeName': 'Benita', 'Initials': 'B', 'LastName': 'Middleton', 'Affiliation': 'Faculty of Health & Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Skene', 'Affiliation': 'Faculty of Health & Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Bagshaw', 'Affiliation': 'Centre for Human Brain Health, University of Birmingham, Birmingham, B15 2TT, UK; School of Psychology, University of Birmingham, Birmingham, B15 2TT, UK.'}]",Sleep medicine,['10.1016/j.sleep.2019.05.001']
592,31298171,Who will benefit from computerized cognitive remediation therapy? Evidence from a multisite randomized controlled study in schizophrenia.,"BACKGROUND


Computerized cognitive remediation therapy (CCRT) is generally effective for the cognitive deficits of schizophrenia. However, there is much uncertainty about what factors mediate or moderate effectiveness and are therefore important to personalize treatment and boost its effects.
METHOD


In total, 311 Chinese inpatients with Diagnostic and Statistical Manual of Mental Disorders-IV schizophrenia were randomized to receive CCRT or Active control for 12 weeks with four to five sessions per week. All participants were assessed at baseline, post-treatment and 3-month follow-up. The outcomes were cognition, clinical symptoms and functional outcomes.
RESULTS


There was a significant benefit in the MATRICS Consensus Cognitive Battery (MCCB) total score for CCRT (F1,258 = 5.62; p = 0.02; effect size was 0.27, 95% confidence interval 0.04-0.49). There were no specific moderators of CCRT improvements. However, across both groups, Wisconsin Card Sort Test improvement mediated a positive effect on functional capacity and Digit Span benefit mediated decreases in positive symptoms. In exploratory analyses younger and older participants showed cognitive improvements but on different tests (younger on Symbol Coding Test, while older on the Spatial Span Test). Only the older age group showed MSCEIT benefits at post-treatment. In addition, cognition at baseline negatively correlated with cognitive improvement and those whose MCCB baseline total score was around 31 seem to derive the most benefit.
CONCLUSIONS


CCRT can improve the cognitive function of patients with schizophrenia. Changes in cognitive outcomes also contributed to improvements in functional outcomes either directly or solely in the context of CCRT. Age and the basic cognitive level of the participants seem to affect the cognitive benefits from CCRT.",2020,"There was a significant benefit in the MATRICS Consensus Cognitive Battery (MCCB) total score for CCRT (F1,258 = 5.62; p = 0.02; effect size was 0.27, 95% confidence interval 0.04-0.49).","['311 Chinese inpatients with Diagnostic and Statistical Manual of Mental Disorders-IV schizophrenia', 'patients with schizophrenia']","['CCRT or Active control', 'Computerized cognitive remediation therapy (CCRT', 'CCRT']","['MSCEIT benefits', 'functional capacity and Digit Span benefit', 'cognitive improvements', 'cognition, clinical symptoms and functional outcomes', 'cognitive function', 'Consensus Cognitive Battery (MCCB) total score for CCRT', 'MCCB baseline total score']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",311.0,0.0451081,"There was a significant benefit in the MATRICS Consensus Cognitive Battery (MCCB) total score for CCRT (F1,258 = 5.62; p = 0.02; effect size was 0.27, 95% confidence interval 0.04-0.49).","[{'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Hongzhen', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Zhiren', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing100088, P.R. China.'}, {'ForeName': 'Zhanjiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing100088, P.R. China.'}, {'ForeName': 'Wenxiang', 'Initials': 'W', 'LastName': 'Quan', 'Affiliation': 'Institute of Mental Health, Peking University, Beijing100191, P.R. China.'}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Mental Health, Peking University, Beijing100191, P.R. China.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Reeder', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, LondonSE5 8AF, UK.""}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Institute of Mental Health, Peking University, Beijing100191, P.R. China.'}, {'ForeName': 'Yizhuang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, LondonSE5 8AF, UK.""}]",Psychological medicine,['10.1017/S0033291719001594']
593,31837906,"Does intramuscular ondansetron have an effect on intramuscular ketamine-associated vomiting in children? A prospective, randomized, double blind, controlled study.","OBJECTIVE


This study was conducted to determine the effect of intramuscular ondansetron on ketamine-associated vomiting in children undergoing procedural sedation.
METHODS


This randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted at the emergency departments of two university-affiliated tertiary care hospitals. Eligible participants included all 6-month to 16-year-old children who received IM ketamine for PSA in the ED. A convenience sampling approach was used and a block randomization method was applied (blocks of four) using a computer-generated random sequence. Patients received ketamine 4 mg/kg or ketamine 4 mg/kg plus ondansetron 0.1 mg/kg intramuscularly. All findings including the occurrence of vomiting and its frequency were then recorded in the data collection sheets.
RESULTS


Of 56 patients who received ondansetron plus ketamin, 7 (12.5%) and 1 (1.8%) experienced vomiting during recovery and before discharge and Of 65 patients in the control group, 14 (21.5%) and 6 (9.2%) experienced vomiting during recovery and before discharge, respectively. The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
CONCLUSION


Intramuscular ondansetron is effective in controlling ketamine-associated vomiting.",2020,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
","['children undergoing procedural sedation', 'emergency departments of two university-affiliated tertiary care hospitals', 'Eligible participants included all 6-month to 16-year-old children who received']","['placebo', 'ketamine', 'IM ketamine', 'Intramuscular ondansetron', 'ketamine 4\u202fmg/kg or ketamine 4\u202fmg/kg plus ondansetron 0.1\u202fmg/kg intramuscularly', 'ondansetron', 'ondansetron plus ketamin']","['vomiting', 'occurrence of vomiting and its frequency', 'rates of vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",65.0,0.545507,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nejati', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: anejati@tumsac.ir.'}, {'ForeName': 'Seyyedhossein Seyyedhoseini', 'Initials': 'SS', 'LastName': 'Davarani', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Talebian', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mtalebian@tums.ac.ir.'}, {'ForeName': 'Firouzi', 'Initials': 'F', 'LastName': 'Hossein', 'Affiliation': 'Department of Paediatrics, Ramsar Campus, Mazandaran University of Medical Science, Mazandaran, Iran. Electronic address: firoozihosein@mazums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: H-akbari@sina.tums.ac.ir.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158445']
594,31837947,Moderate-intensity continuous exercise is superior to high-intensity interval training in the proportion of VO 2peak  responders after ACS.,"INTRODUCTION AND OBJECTIVES


We compared the effects of 12 weeks of low-volume high-intensity interval training (LV-HIIT) vs moderate-intensity continuous exercise training (MICET) on cardiopulmonary exercise test parameters and the proportion of non/low responders (NLR) to exercise training in post-acute coronary syndrome (ACS) patients.
METHODS


Patients with a recent ACS were randomized to LV-HIIT, MICET, or a usual care group. LV-HIIT consisted of 2 to 3 sets of 6 to 10minutes with repeated bouts of 15 to 30seconds at 100% of peak workload alternating with 15 to 30seconds of passive recovery. Cardiopulmonary exercise test parameters were assessed, and key exercise variables were calculated. Training response was assessed according to the median VO 2peak  change post vs pretraining in the whole cohort (stratification NLR vs high response).
RESULTS


Fifty patients were included in the analysis (LV-HIIT, n=23; MICET, n=18; usual care, n=9) and 74% were male. The proportion of NLR was higher in the LV-HIIT group than in the MICET group (LV-HIIT 61%, MICET 21%, and usual care 80%; P=.0040). VO 2peak -dependent variables (VO 2peak , percent-predicted VO 2peak ) improved in both training groups (P=.002 and P <.0001 for time with LV-HIIT and MICET, respectively), but the improvement was more pronounced with MICET (P=.004 and P=.001 for interaction, respectively). The ΔVO 2 /Δworkload slope improved only with MICET (P=.021).
CONCLUSIONS


In patients with a recent ACS, several prognostic VO 2peak -dependent variables were improved after LV-HIIT, but the improvement was more pronounced or only found after MICET. Low-volume HIIT resulted in a higher proportion of NLR than isocaloric MICET. Clinical trialsregistered at ClinicalTrials.gov (Identifiers: NCT03414996 and NCT02048696).",2020,"VO 2peak -dependent variables (VO 2peak , percent-predicted VO 2peak ) improved in both training groups (P=.002 and P <.0001 for time with LV-HIIT and MICET, respectively), but the improvement was more pronounced with MICET (P=.004 and P=.001 for interaction, respectively).","['post-acute coronary syndrome (ACS) patients', 'Fifty patients were included in the analysis (LV-HIIT, n=23; MICET, n=18; usual care, n=9) and 74% were male', 'Patients with a recent ACS']","['LV-HIIT, MICET, or a usual care group', 'exercise training', 'MICET', 'low-volume high-intensity interval training (LV-HIIT) vs moderate-intensity continuous exercise training (MICET']","['Training response', 'VO 2peak -dependent variables (VO 2peak , percent-predicted VO 2peak ', 'proportion of NLR', 'several prognostic VO 2peak -dependent variables']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",50.0,0.0348929,"VO 2peak -dependent variables (VO 2peak , percent-predicted VO 2peak ) improved in both training groups (P=.002 and P <.0001 for time with LV-HIIT and MICET, respectively), but the improvement was more pronounced with MICET (P=.004 and P=.001 for interaction, respectively).","[{'ForeName': 'Lukas-Daniel', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada; University Clinic for Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada; Research Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Annik', 'Initials': 'A', 'LastName': 'Fortier', 'Affiliation': 'Montreal Health Innovations Coordinating Center, Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lalongé', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada; Research Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada; Research Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gayda', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (EPIC) Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada; Research Center, Montreal Heart Institute and Université de Montréal, Montreal, Canada. Electronic address: mathieu.gayda@icm-mhi.org.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2019.09.013']
595,32030911,Increased Visceral Adipose Tissue Without Weight Retention at 59 Weeks Postpartum.,"OBJECTIVE


This study aimed to determine whether controlling maternal gestational weight gain (GWG) influences adipose tissue distribution at 1 year postpartum.
METHODS


Women with overweight or obesity (n = 210, BMI ≥ 25 or ≥ 30) were randomized to a lifestyle intervention (LI) designed to control GWG or to usual obstetrical care (UC). Measures included anthropometry, whole-body magnetic resonance imaging for visceral (VAT), intermuscular, and subcutaneous adipose tissue, and cardiometabolic risk factors in pregnancy (15 and 35 weeks) and after delivery (15 and 59 weeks).
RESULTS


Baseline (15 weeks) characteristics were similar (mean [SD]: age, 33.8 [4.3] years; weight, 81.9 [13.7] kg; BMI, 30.4 [4.5]; gestational age at randomization, 14.9 [0.8] weeks). LI had less GWG (1.79 kg; P = 0.003) and subcutaneous adipose tissue gain at 35 weeks gestation (P < 0.01). UC postpartum weight (2.92 kg) was higher at 15 weeks but not different from baseline or LI at 59 weeks postpartum. Postpartum VAT increased from baseline in LI by 0.23 kg at 15 weeks and 0.55 kg at 59 weeks; in UC, it increased by 0.34 kg at 15 and 59 weeks. Intermuscular adipose tissue remained elevated in LI (0.22 kg) at 59 weeks. VAT was associated with several cardiometabolic risk factors at 59 weeks.
CONCLUSIONS


Despite no weight retention at 59 weeks postpartum, women had increased VAT by ~30%. Postpartum modifiable behaviors are warranted to lower the risk of VAT retention.",2020,LI had less GWG (1.79 kg; P = 0.003) and subcutaneous adipose tissue gain at 35 weeks gestation (P < 0.01).,"['33.8 [4.3] years; weight, 81.9 [13.7] kg; BMI, 30.4 [4.5]; gestational age at randomization, 14.9 [0.8] weeks', 'Women with overweight or obesity (n\u2009']","['lifestyle intervention (LI) designed\xa0to control GWG or to usual obstetrical care (UC', 'VAT']","['Postpartum VAT', 'Intermuscular adipose tissue remained elevated in LI', 'UC postpartum weight', 'GWG', 'Increased Visceral Adipose Tissue Without Weight Retention', 'maternal gestational weight gain (GWG) influences adipose tissue distribution', 'anthropometry, whole-body magnetic resonance imaging for visceral (VAT), intermuscular, and subcutaneous adipose tissue, and cardiometabolic risk factors in pregnancy', 'subcutaneous adipose tissue gain', 'several cardiometabolic risk factors', 'weight retention']","[{'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205484', 'cui_str': 'Obstetrical (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",,0.1477,LI had less GWG (1.79 kg; P = 0.003) and subcutaneous adipose tissue gain at 35 weeks gestation (P < 0.01).,"[{'ForeName': 'Isaiah', 'Initials': 'I', 'LastName': 'Janumala', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Toro-Ramos', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Widen', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Rosenn', 'Affiliation': 'Department of Obstetrics and Gynecology, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Crane', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Center for Family and Community Medicine, Columbia University, New York, New York, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Gidwani', 'Affiliation': 'Department of Pediatrics, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Paley', 'Affiliation': 'Department of Pediatrics, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Thornton', 'Affiliation': 'Thornton Consulting, Mahopac, New York, USA.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22736']
596,31287897,Does the structure (tunneled vs. free-roam) and content (if-then plans vs. choosing strategies) of a brief online alcohol intervention effect engagement and effectiveness? A randomized controlled trial.,"Despite the potential of brief online interventions for reducing alcohol consumption, their effectiveness may be compromised by low levels of engagement and the inclusion of ineffective behavior change techniques. To test whether (i) a tunneled version of an intervention (where the content is delivered in a prespecified order) leads to greater engagement and greater reductions in alcohol consumption than a free-roam version (where the content can be viewed in any order) and (ii) forming if-then plans linking strategies to cut down with high-risk situations leads to greater reductions in alcohol consumption than only choosing strategies to cut down. Participants (N = 286 university staff and students) were randomly allocated to one of four versions of a brief online alcohol intervention in a 2 (structure: tunneled vs. free-roam) by 2 (planning: strategies vs. if-then plans) factorial design. Engagement (pages visited, time) was recorded automatically. Alcohol consumption (weekly units) was assessed at baseline and 1- and 6-month follow-up. Participants who received the tunneled version viewed significantly more pages and spent significantly more time on the website than those who received the free-roam version. Significant reductions in alcohol consumption were observed at follow-up; however, neither the structure of the intervention nor planning had a significant effect on reductions in alcohol consumption. Tunneled online interventions can increase engagement, but this may not translate into greater changes in behavior. Further experimental research using factorial designs is needed to identify the key behavior change techniques to include in brief online interventions.",2019,Participants who received the tunneled version viewed significantly more pages and spent significantly more time on the website than those who received the free-roam version.,['Participants (N = 286 university staff and students'],"['Tunneled online interventions', 'brief online alcohol intervention in a 2 (structure: tunneled vs. free-roam']",['alcohol consumption'],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",,0.0343121,Participants who received the tunneled version viewed significantly more pages and spent significantly more time on the website than those who received the free-roam version.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Norman', 'Affiliation': 'Department of Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Millings', 'Affiliation': 'Department of Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pechey', 'Affiliation': 'Haringey Advisory Group on Alcohol, London, 0HJ, UK.'}]",Translational behavioral medicine,['10.1093/tbm/ibz110']
597,31272216,Effect of Simple Interrupted Suture Spacing on Aesthetic and Functional Outcomes of Skin Closures.,"BACKGROUND


Dermatologic surgeons are trained in fundamental wound closure techniques that minimize wound tension and tissue ischemia to optimize healing and create discrete scars. These include orienting excisions along resting skin tension lines, handling tissue edges with care, and avoiding strangulation while tying suture. Another variable that may affect wound healing and cosmetic outcomes is the spacing between sutures.
OBJECTIVE


This prospective, single-centre, randomized, split-scar comparison trial was designed to explore how suture spacing distance affects wound complication rate and scar cosmesis.
METHODS


Elliptical surgical wounds of the trunk and extremities were repaired with simple interrupted sutures with varying suture spacing. One half of each wound was repaired with high-density suture spacing (approximately 5 mm apart) and the other with low-density suture spacing (approximately 10 mm apart). Wounds were evaluated at 2-week suture removal for complications, and then reevaluated at 3 and 6 months for cosmesis using the Patient and Observer Scar Assessment Scale score.
RESULTS


Results revealed no significant difference in minor wound complications during the early healing process between high- and low-density suture spacing. At 3 months postoperatively, physicians and patients alike preferred the aesthetics of the low-density suture placement. By 6 months postoperatively, this preference disappeared.
CONCLUSIONS


These results suggest that suture spacing may affect early scar formation. Additionally, placing sutures farther apart results in fewer total puncture wounds, decreases tissue trauma, and saves surgical time while conserving suture material. Therefore, dermatologic surgeons should consider placing fewer percutaneous sutures during wound repair.",2019,"RESULTS


Results revealed no significant difference in minor wound complications during the early healing process between high- and low-density suture spacing.","['Skin Closures', 'Elliptical surgical wounds of the trunk and extremities were repaired with']","['simple interrupted sutures with varying suture spacing', 'Simple Interrupted Suture Spacing']","['minor wound complications', 'total puncture wounds, decreases tissue trauma, and saves surgical time', 'early scar formation', 'wound complication rate and scar cosmesis', 'wound healing and cosmetic outcomes', 'Observer Scar Assessment Scale score']","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1096106'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0387323,"RESULTS


Results revealed no significant difference in minor wound complications during the early healing process between high- and low-density suture spacing.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Stoecker', 'Affiliation': 'Department of Dermatology, Good Samaritan Regional Medical Center/Silver Falls Dermatology, Salem, OR, USA.'}, {'ForeName': 'Collin M', 'Initials': 'CM', 'LastName': 'Blattner', 'Affiliation': 'Department of Dermatology, Good Samaritan Regional Medical Center/Silver Falls Dermatology, Salem, OR, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Howerter', 'Affiliation': 'Department of Dermatology and Dermatologic Surgery, Good Samaritan Regional Medical Center/Silver Falls Dermatology, Salem, OR, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Fancher', 'Affiliation': 'Department of Dermatology and Dermatologic Surgery, Good Samaritan Regional Medical Center/Silver Falls Dermatology, Salem, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Department of Dermatology, Good Samaritan Regional Medical Center/Silver Falls Dermatology, Salem, OR, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lear', 'Affiliation': 'Department of Dermatology and Dermatologic Surgery, Good Samaritan Regional Medical Center/Silver Falls Dermatology, Salem, OR, USA.'}]",Journal of cutaneous medicine and surgery,['10.1177/1203475419861077']
598,31271210,Brief CBT for insomnia delivered in primary care to patients endorsing suicidal ideation: a proof-of-concept randomized clinical trial.,"Insomnia co-occurs frequently with major depressive disorder (MDD) and posttraumatic stress disorder (PTSD); all three conditions are prevalent among primary care patients and associated with suicidal ideation (SI). The purpose of the article was to test the effects of a brief cognitive behavioral therapy for insomnia (bCBTi) and the feasibility of delivering it to primary care patients with SI and insomnia in addition to either MDD and/or PTSD. Fifty-four patients were randomized to receive either bCBTi or treatment-as-usual for MDD and/or PTSD. The primary outcome was SI intensity as measured by the Columbia-Suicide Severity Rating Scale; secondary clinical outcomes were measured by the Insomnia Severity Index, Patient Health Questionnaire for depression, and PTSD Symptom Checklist. Effect sizes controlling for baseline values and sample size were calculated for each clinical outcome comparing pre-post differences between the two conditions with Hedge's g. The effect size of bCBTi on SI intensity was small (0.26). Effects were large on insomnia (1.91) and depression (1.16) with no effect for PTSD. There was a marginally significant (p = .069) effect of insomnia severity mediating the intervention's effect on SI. Findings from this proof-of-concept trial support the feasibility of delivering bCBTi in primary care and its capacity to improve mood and sleep in patients endorsing SI. The results do not support bCBTi as a stand-alone intervention to reduce SI, but this or other insomnia interventions may be considered as components of suicide prevention strategies.",2019,There was a marginally significant (p = .069) effect of insomnia severity mediating the intervention's effect on SI.,"['primary care patients with SI and insomnia in addition to either MDD and/or PTSD', 'Fifty-four patients', 'patients endorsing SI', 'patients endorsing suicidal ideation', 'primary care patients and associated with suicidal ideation (SI']","['bCBTi', 'bCBTi or treatment-as-usual for MDD and/or PTSD', 'cognitive behavioral therapy', 'Brief CBT']","['SI', 'SI intensity', 'Insomnia Severity Index, Patient Health Questionnaire for depression, and PTSD Symptom Checklist', 'SI intensity as measured by the Columbia-Suicide Severity Rating Scale; secondary clinical outcomes']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",54.0,0.0407248,There was a marginally significant (p = .069) effect of insomnia severity mediating the intervention's effect on SI.,"[{'ForeName': 'Wilfred R', 'Initials': 'WR', 'LastName': 'Pigeon', 'Affiliation': 'VISN 2 Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center, Canandaigua, NY, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Funderburk', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Cross', 'Affiliation': 'VISN 2 Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center, Canandaigua, NY, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bishop', 'Affiliation': 'VISN 2 Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center, Canandaigua, NY, USA.'}, {'ForeName': 'Hugh F', 'Initials': 'HF', 'LastName': 'Crean', 'Affiliation': 'VISN 2 Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center, Canandaigua, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz108']
599,31839392,Addition of 3% hydrogen peroxide to standard skin preparation reduces Cutibacterium acnes-positive culture rate in shoulder surgery: a prospective randomized controlled trial.,"BACKGROUND


Hydrogen peroxide is an inexpensive and effective antimicrobial agent that can be implemented in surgical skin preparations. The purpose of this study was to evaluate the decolonization effect of Cutibacterium acnes when adding hydrogen peroxide to a standard sterile preparation for shoulder surgery.
METHODS


This was a single-institution, prospective, randomized controlled trial of male patients undergoing shoulder arthroscopy (April 2018 and May 2019). Patients were randomized to a standard skin preparation vs. an additional sterile preparation with 3% hydrogen peroxide. After draping, a 3-mm punch biopsy was obtained from the posterior arthroscopic portal site of all patients. Anaerobic and aerobic culture substrates were used and held for 13 days.
RESULTS


Seventy male patients were randomized into the hydrogen peroxide group and 70 male patients were in the traditional group. Twelve (17.1%) patients in the hydrogen peroxide group and 24 (34.2%) patients in the traditional group had positive cultures for C acnes (P = .033). Cultures were positive at a mean of 4.5 days (range 3-7) in the hydrogen peroxide group and 4.1 days (range 3-8) in the traditional group (P = .48). There were no cases of skin reaction to the surgical preparation in either group.
DISCUSSION


The results of this study suggest that the addition of hydrogen peroxide to preoperative surgical site preparation can reduce the C acnes culture rate. Hydrogen peroxide is inexpensive and can be added to the typical skin preparation used prior to shoulder surgery without substantial risk of skin reactions.",2020,Cultures were positive at a mean of 4.5 days (range 3-7) in the hydrogen peroxide group and 4.1 days (range 3-8) in the traditional group (P = .48).,"['Seventy male patients', 'male patients undergoing shoulder arthroscopy (April 2018 and May 2019', 'group and 70 male patients were in the traditional group', 'shoulder surgery']","['standard skin preparation vs. an additional sterile preparation with 3% hydrogen peroxide', 'hydrogen peroxide', 'hydrogen peroxide to standard skin preparation', 'Hydrogen peroxide']",['skin reaction'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation (procedure)'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}]",70.0,0.0710899,Cultures were positive at a mean of 4.5 days (range 3-7) in the hydrogen peroxide group and 4.1 days (range 3-8) in the traditional group (P = .48).,"[{'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Stull', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Thema A', 'Initials': 'TA', 'LastName': 'Nicholson', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Davis', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Surena', 'Initials': 'S', 'LastName': 'Namdari', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA. Electronic address: surena.namdari@rothmanortho.com.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.09.038']
600,31244352,Childbirth experiences among women with fear of birth randomized to internet-based cognitive therapy or midwife counseling.,"Background:  Although women with fear of birth often report negative birth experiences, few studies have focused on their experiences in the long term. The aim of this study was to compare birth experiences a year after childbirth in two groups of women receiving treatment for experiencing fear of birth during pregnancy. Methods:  As part of the U-CARE: Pregnancy Trial, a prospective multicenter randomized controlled trial comparing the effects of internet-based cognitive behavioral therapy (iCBT) and standard care among pregnant women with fear of birth. Women were recruited at three Swedish hospitals following a screening procedure that assessed their fear of birth. Data were collected online with the Childbirth Experience Questionnaire (CEQ), one question about the overall birth experience, and questions about personal background, collected before randomization. Results:  A total of 181 women responded to the follow-up questionnaire a year after childbirth. Approximately half of participants reported a less positive birth experience. Preferred mode of birth, actual mode of birth, marital status and psychiatric history were associated with the domains of the CEQ. However, no statistically significant differences emerged between the treatment groups. Conclusions:  Being randomized to receive iCBT or counseling with midwives for fear of birth was not associated with perceptions of the birth experience assessed a year after birth. Most participants reported less-than-positive birth experiences and scored low on the domain of the CEQ reflecting  Own capacity . In response, additional research remains necessary to identify the best model of care that might facilitate positive experiences with giving birth among women with fear of birth.",2020,"Preferred mode of birth, actual mode of birth, marital status and psychiatric history were associated with the domains of the CEQ.","['Women were recruited at three Swedish hospitals following a screening procedure that assessed their fear of birth', 'birth experiences a year after childbirth in two groups of women receiving treatment for experiencing fear of birth during pregnancy', 'pregnant women with fear of birth', 'women with fear of birth', '181 women responded to the follow-up questionnaire a year after childbirth', 'women with fear of birth randomized to']","['internet-based cognitive therapy or midwife counseling', 'internet-based cognitive behavioral therapy (iCBT) and standard care', 'iCBT']","['Childbirth experiences', 'Childbirth Experience Questionnaire (CEQ', 'positive birth experience']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",181.0,0.0965251,"Preferred mode of birth, actual mode of birth, marital status and psychiatric history were associated with the domains of the CEQ.","[{'ForeName': 'Ingegerd', 'Initials': 'I', 'LastName': 'Hildingsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rubertsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2019.1634047']
601,32406770,Development of Quality-Controlled Low-Dose Protocols for Radiography in the Neonatal ICU Using a New Mobile Digital Radiography System.,"OBJECTIVE.  The aim of this study was to develop a low-dose radiography protocol for the neonatal ICU (NICU) using a new mobile digital radiography system with advanced denoising image processing and to evaluate the noninferiority of that protocol.  SUBJECTS AND METHODS.  In this prospective randomized study, 40 neonates in the NICU underwent radiography of the thorax and abdomen with two different mobile radiography units: conventional technique on one unit (50 kV, 1.6 mAs, and no additional filtration) and a new technique on another unit (54 kV, 0.1-mm Cu filtration). Three low-dose protocols for the second unit were developed in a phantom study: protocol A (100% equivalent dose with conventional protocol), protocol B (80% equivalent dose), and protocol C (64% equivalent dose). The noninferiority of each low-dose protocol was assessed by three independent readers using image quality criteria.  RESULTS.  Forty patients each underwent three pairs of radiography examinations (protocol A and the conventional protocol, protocol B and the conventional protocol, and protocol C and the conventional protocol), except one pair that did not include one image of the conventional protocol. The interrater reliability among the three readers was 0.91 ( p  < 0.001). Both of the low-dose protocols (B and C) were statistically noninferior to the conventional protocol with respect to overall image quality. Protocol B better depicted almost all anatomic landmarks and had better overall image quality than the conventional protocol.  CONCLUSION.  Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.",2020,"Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.","['40 neonates in the NICU underwent radiography of the thorax and abdomen with two different mobile radiography units: conventional technique on one unit (50 kV, 1.6 mAs, and no additional filtration) and a new technique on another unit (54 kV', 'Forty patients each underwent three pairs of']","['radiography examinations (protocol A and the conventional protocol, protocol B and the conventional protocol, and protocol C and the conventional protocol), except one pair that did not include one image of the conventional protocol']","['overall image quality', 'interrater reliability']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0597311,"Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.","[{'ForeName': 'Gayoung', 'Initials': 'G', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Jung-Eun', 'Initials': 'JE', 'LastName': 'Cheon', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Young Hun', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Seung Han', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yeon Jin', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Sun Won', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22269']
602,31280772,Outcomes of a randomised pilot trial of a nurse-led clinic for patients after percutaneous coronary intervention.,"BACKGROUND


Hospitalisation for percutaneous coronary intervention (PCI) in Australia is reducing. Patients who undergo PCI may be discharged home without a post-discharge health management plan, referral for secondary prevention, or understand their chronic condition. Subsequently, negative psychological symptoms such as anxiety and depression may be experienced in the post-discharge period.
OBJECTIVES


This study assessed the effectiveness of a nurse-led clinic on patients' cardiac self-efficacy and negative psychological symptoms of anxiety and depression 1-week post-PCI discharge.
METHODS


One-hundred and eighty-eight potential participants were screened, and 33 participants were block-randomised to study groups. The nurse-led clinic used a person-centred approach and delivered tailored education, health assessment, and post-discharge support. In Phase 1, the Cardiac Self-efficacy Scale and State-Trait Anxiety Inventory measured primary outcomes, while the Cardiac Depression Scale was used to measure secondary outcomes. Phase 2 evaluated participants' experiences and healthcare professionals' perceptions of the intervention through semi-structured interviews.
RESULTS


In Phase 1, intervention group participants did not show improvements in mental health indicators compared to standard care group participants, except for a moderate reduction in anxiety levels (d = 0.50). Phase 2 qualitative findings; however, highlighted the benefits of the nurse-led clinic.
CONCLUSIONS


Overall, findings suggest that nurse-led clinics may be valuable to reduce anxiety and act as a supportive measure in the early post-discharge period until commencement of a secondary prevention program. Further research with a more powered sample is needed to determine the significance of the findings.",2019,"In Phase 1, intervention group participants did not show improvements in mental health indicators compared to standard care group participants, except for a moderate reduction in anxiety levels (d = 0.50).","['patients after percutaneous coronary intervention', 'potential participants were screened, and 33 participants were block-randomised to study groups', 'Patients who undergo PCI may be discharged home without a post-discharge health management plan, referral for secondary prevention, or understand their chronic condition', ""Phase 2 evaluated participants' experiences and healthcare professionals' perceptions of the intervention through semi-structured interviews"", 'One-hundred and eighty-eight']","['percutaneous coronary intervention (PCI', 'nurse-led clinic']","['mental health indicators', 'Cardiac Self-efficacy Scale and State-Trait Anxiety Inventory', 'anxiety levels', 'Cardiac Depression Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C2718021', 'cui_str': 'Nurse-Led Clinics'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",188.0,0.106099,"In Phase 1, intervention group participants did not show improvements in mental health indicators compared to standard care group participants, except for a moderate reduction in anxiety levels (d = 0.50).","[{'ForeName': 'Katina M', 'Initials': 'KM', 'LastName': 'Corones-Watkins', 'Affiliation': 'School of Nursing, Queensland University of Technology, Kelvin Grove Campus, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove Campus, Australia. Electronic address: k.corones-watkins@griffith.edu.au.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Theobald', 'Affiliation': 'School of Nursing, Queensland University of Technology, Kelvin Grove Campus, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove Campus, Australia.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'White', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove Campus, Australia; School of Psychology and Counselling, Queensland University of Technology, Kelvin Grove Campus, Australia.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2018.06.009']
603,31758941,Do Regional Nerve Blocks Before Bimaxillary Surgery Reduce Postoperative Pain?,"PURPOSE


Any elective surgery should be as atraumatic to the patient as possible to allow for a comfortable postoperative recovery. The present study was performed to evaluate the efficacy of preoperative regional blocks in reducing pain, discomfort, and analgesic use in patients scheduled to undergo bimaxillary surgery.
PATIENTS AND METHODS


A prospective, double-blind, randomized controlled trial was conducted to include all patients aged 16 to 30 years requiring bimaxillary surgery. We excluded patients with syndromes and systemic conditions. The primary predictor variable was the maxillary and mandibular nerve blocks (extraoral lateral pterygoid method) administered preoperatively in the operating room using 0.25% bupivacaine hydrochloride. Standard anesthetic and postoperative protocols were followed. The primary outcome variable was postoperative pain. The secondary outcome variables were postoperative discomfort, analgesic consumption, duration of surgery, and blood loss. The unpaired t test and Mann-Whitney U test were used for statistical analyses, with P < .05 considered to indicate statistical significance.
RESULTS


A total of 110 patients were included in the study (55 in the control group and 55 in the test group), of whom 61 were female and 49 were male. Postoperative pain, recorded using a visual analog scale was significantly lower (P < .001) in the test group compared with the control group. Secondary outcome variables such as postoperative discomfort and analgesic consumption were also significantly lower in the test group. A significant positive correlation was present between the duration of surgery and pain measured at 6, 12, 24, and 48 hours postoperatively in both groups.
CONCLUSIONS


From our results, it can be established that the administration of preoperative regional blocks using 0.25% bupivacaine immediately before bimaxillary surgery can effectively minimize patients' postoperative pain, discomfort, and consumption of analgesics.",2020,"Postoperative pain, recorded using a visual analog scale was significantly lower (P < .001) in the test group compared with the control group.","['patients aged 16 to 30\xa0years requiring bimaxillary surgery', 'patients scheduled to undergo bimaxillary surgery', 'A total of 110 patients were included in the study (55 in the control group and 55 in the test group), of whom 61 were female and 49 were male', 'patients with syndromes and systemic conditions']","['bupivacaine', 'preoperative regional blocks', 'bupivacaine hydrochloride']","['postoperative pain', 'duration of surgery and pain', 'Postoperative pain', 'maxillary and mandibular nerve blocks (extraoral lateral pterygoid method', 'pain, discomfort, and analgesic use', 'postoperative discomfort, analgesic consumption, duration of surgery, and blood loss', 'Postoperative Pain', 'visual analog scale', 'postoperative discomfort and analgesic consumption', 'postoperative pain, discomfort, and consumption of analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0394800', 'cui_str': 'Local anesthetic mandibular nerve block (procedure)'}, {'cui': 'C0442089', 'cui_str': 'Extraoral approach (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",110.0,0.172455,"Postoperative pain, recorded using a visual analog scale was significantly lower (P < .001) in the test group compared with the control group.","[{'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Shetty', 'Affiliation': 'Director, Nitte Meenakshi Institute of Craniofacial Surgery, K.S. Hegde Hospital; and Professor and Head, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Bylapudi', 'Initials': 'B', 'LastName': 'BhanuPrakash', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Surgical Fellow, Nitte Meenakshi Institute of Craniofacial Surgery, K.S. Hegde Hospital; and Lecturer, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Kishore P', 'Affiliation': 'Head, Department of Craniofacial Orthodontics, and Professor, Department of Orthodontics and Dentofacial Orthopaedics, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Menon', 'Affiliation': 'Surgical Fellow, Nitte Meenakshi Institute of Craniofacial Surgery, K.S. Hegde Hospital; and Lecturer, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India. Electronic address: drakashmenon@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.10.014']
604,29904740,Postresection CA19-9 and margin status as predictors of recurrence after adjuvant treatment for pancreatic carcinoma: Analysis of NRG oncology RTOG trial 9704.,"Purpose


NRG Oncology RTOG 9704 was the first adjuvant trial to validate the prognostic value of postresection CA19-9 levels for survival in patients with pancreatic carcinoma. The data resulting from this study also provide information about predictors of recurrence that may be used to tailor individualized management in this disease setting. This secondary analysis assessed the prognostic value of postresection CA19-9 and surgical margin status (SMS) in predicting patterns of disease recurrence.
Methods and materials


This multicenter cooperative trial included participants who were enrolled as patients at oncology treatment sites in the United States and Canada. The study included 451 patients analyzable for SMS, of whom 385 were eligible for postresection CA19-9 analysis. Postresection CA19-9 was analyzed at cut points of 90, 180, and continuously. Patterns of disease recurrence included local/regional recurrence (LRR) and distant failure (DF). Multivariable analyses included treatment, tumor size, and nodal status. To adjust for multiple comparisons, a  P  value of ≤ .01 was considered statistically significant and > .01 to ≤ .05 to be a trend.
Results


For CA19-9, 132 (34%) patients were Lewis antigen-negative (no CA19-9 expression), 200 (52%) had levels <90, and 220 (57%) had levels <180. A total of 188 patients (42%) had negative margins, 152 (34%) positive, and 111 (25%) unknown. On univariate analysis, CA19-9 cut at 90 was associated with increases in LRR (trend) and DF. Results were similar at the 180 cut point. SMS was not associated with an increase in LRR on univariate or multivariate analyses. On multivariable analysis, CA19-9 ≥ 90 was associated with increased LRR and DF. Results were similar at the 180 cut point.
Conclusions


In this prospective evaluation, postresection CA19-9 was a significant predictor of both LRR and DF, whereas SMS was not. These findings support consideration of adjuvant radiation therapy dose intensification in patients with elevated postresection CA19-9.",2018,"On univariate analysis, CA19-9 cut at 90 was associated with increases in LRR (trend) and DF.","['participants who were enrolled as patients at oncology treatment sites in the United States and Canada', 'patients with pancreatic carcinoma', 'pancreatic carcinoma', '188 patients (42%) had negative margins, 152 (34%) positive, and 111 (25%) unknown', '451 patients analyzable for SMS, of whom 385 were eligible for postresection CA19-9 analysis', 'patients with elevated postresection CA19-9']",[],"['Lewis antigen-negative', 'LRR (trend) and DF', 'prognostic value of postresection CA19-9 and surgical margin status (SMS', 'tumor size, and nodal status', 'local/regional recurrence (LRR) and distant failure (DF', 'LRR and DF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0235974', 'cui_str': 'Pancreatic Acinar Carcinoma'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C4517751', 'cui_str': 'Three hundred and eighty-five'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229985', 'cui_str': 'Margins of Excision'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",451.0,0.0553589,"On univariate analysis, CA19-9 cut at 90 was associated with increases in LRR (trend) and DF.","[{'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Regine', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Winter', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Abrams', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Safran', 'Affiliation': 'Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Ivan L', 'Initials': 'IL', 'LastName': 'Kessel', 'Affiliation': 'University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Yuhchyau', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Fugazzi', 'Affiliation': 'Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Donnelly', 'Affiliation': 'Northwestern Memorial Hospital, Chicago, Illinois.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'DiPetrillo', 'Affiliation': 'Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Narayan', 'Affiliation': 'Michigan Cancer Research Consortium CCOP, Ann Arbor, Michigan.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Plastaras', 'Affiliation': 'University of Pennsylvania Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Gaur', 'Affiliation': 'Kansas City CCOP, Kansas City, Missouri.'}, {'ForeName': 'Guila', 'Initials': 'G', 'LastName': 'Delouya', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal-Notre Dame, Montreal, Quebec.""}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Meyer', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Haddock', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mukund S', 'Initials': 'MS', 'LastName': 'Didolkar', 'Affiliation': 'Sinai Hospital of Baltimore, Baltimore, Maryland.'}, {'ForeName': 'Gilbert D A', 'Initials': 'GDA', 'LastName': 'Padula', 'Affiliation': 'Grand Rapids Clinical Oncology Program (GRCOP), Grand Rapids, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'St Francis Regional Medical Center, Wichita, Kansas.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Hoffman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Crane', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Advances in radiation oncology,['10.1016/j.adro.2018.01.003']
605,31800462,"VITREOUS PROSTAGLANDIN E2 CHANGES AFTER TOPICAL ADMINISTRATION OF DICLOFENAC 0.1%, INDOMETHACIN 0.5%, NEPAFENAC 0.3%, AND BROMFENAC 0.09.","PURPOSE


To evaluate the vitreous concentration of different nonsteroidal anti-inflammatory drugs (NSAIDs) after topical administration and the related prostaglandin E2 (PGE2) levels in patients undergoing pars plana vitrectomy.
METHODS


A prospective, randomized, investigator-masked study was performed. One hundred four patients scheduled for a pars plana vitrectomy for an epiretinal membrane or a macular hole were randomized to receive topical diclofenac 0.1%, indomethacin 0.5%, nepafenac 0.3%, bromfenac 0.09%, or placebo 3 days before surgery. At the beginning of surgery, a sample of undiluted vitreous was collected in each patient to assess NSAIDs concentration and PGE2 levels.
RESULTS


The median vitreous concentrations were 203.35 (interquartile range 146.54-264.18) pg/mL for diclofenac, 243.45 (interquartile range 156.96-365.37) pg/mL for nepafenac, 438.21 pg/mL (interquartile range, 282.52-645.87) for its active metabolite amfenac, 350.14 (interquartile range, 290.88-481.95) pg/mL for indomethacin, and 274.59 (245.43-358.25) pg/mL for bromfenac. Vitreous PGE2 levels were significantly lower for all the NSAIDs groups compared with the control group (P < 0.001). A statistically significant higher vitreous PGE2 level was found in the diclofenac group compared with the other NSAIDs groups (P < 0.05).
CONCLUSION


Topical NSAIDs achieve sufficient vitreous concentration to decrease vitreous PGE2 levels compared with the control group. The different efficacy in reducing PGE2 concentration may affect the management of posterior segment inflammation.",2020,Vitreous PGE2 levels were significantly lower for all the NSAIDs groups compared with the control group (P < 0.001).,"['patients undergoing pars plana vitrectomy', 'One hundred four patients scheduled for a pars plana vitrectomy for an epiretinal membrane or a macular hole']","['diclofenac', 'Topical NSAIDs', 'nonsteroidal anti-inflammatory drugs (NSAIDs', 'indomethacin', 'topical diclofenac 0.1%, indomethacin 0.5%, nepafenac 0.3%, bromfenac 0.09%, or placebo']","['vitreous PGE2 levels', 'vitreous PGE2 level', 'prostaglandin E2 (PGE2) levels', 'Vitreous PGE2 levels', 'median vitreous concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal Membrane'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0054094', 'cui_str': 'bromfenac'}, {'cui': 'C4517419', 'cui_str': 'Zero point zero nine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",104.0,0.120903,Vitreous PGE2 levels were significantly lower for all the NSAIDs groups compared with the control group (P < 0.001).,"[{'ForeName': 'Marco R', 'Initials': 'MR', 'LastName': 'Pastore', 'Affiliation': 'Department of Medical, Surgical Sciences and Health, Eye Clinic, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'De Giacinto', 'Affiliation': 'Department of Medical, Surgical Sciences and Health, Eye Clinic, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Cirigliano', 'Affiliation': 'Department of Medical, Surgical Sciences and Health, Eye Clinic, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'DʼAloisio', 'Affiliation': 'Department of Medical, Surgical Sciences and Health, Eye Clinic, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Addobbati', 'Affiliation': 'Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Agostinis', 'Affiliation': 'Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Oriano', 'Initials': 'O', 'LastName': 'Radillo', 'Affiliation': 'Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Martino', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Cecchini', 'Affiliation': 'Department of Medical, Surgical Sciences and Health, Eye Clinic, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Tognetto', 'Affiliation': 'Department of Medical, Surgical Sciences and Health, Eye Clinic, University of Trieste, Trieste, Italy.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002674']
606,31796263,Knowledge is power: Providing previsit insurance coverage information of body contouring procedures to improve understanding and satisfaction in the massive weight loss patient.,"INTRODUCTION


Because of the prevalence of obesity worldwide, the rates of bariatric surgery are increasing. Bariatric surgery is covered by insurance; however, often, a surgery to correct massive weight loss surgeries is not covered despite patient perception.
METHODS


One hundred patients were identified by their initial visit to the institutional Life After Weight Loss center. Fifty of them were randomized into receiving previsit educational materials about their individual insurance plans. All the patients were surveyed to assess whether this education improved their understanding and overall consultation experience.
RESULTS


Although a majority of patients believed ""panniculectomy"" would be covered by insurance, most subjects overestimated insurance coverage for other procedures. Nearly all respondents (93.8%) agreed that previsit educational material improved their understanding and the satisfaction of the visit.
CONCLUSION


Many patients believe body contouring procedures to be covered by insurance, although most are not. By providing patients with their individualized insurance plans, patients report improved understanding and overall satisfaction with the consultation.",2020,"Nearly all respondents (93.8%) agreed that previsit educational material improved their understanding and the satisfaction of the visit.
",['One hundred patients were identified by their initial visit to the institutional Life'],['previsit educational materials'],['previsit educational material improved their understanding and the satisfaction of the visit'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",100.0,0.0201491,"Nearly all respondents (93.8%) agreed that previsit educational material improved their understanding and the satisfaction of the visit.
","[{'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Myers', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Rochester, Rochester NY 14642, United States.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Park', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Rochester, Rochester NY 14642, United States.'}, {'ForeName': 'Valeriia', 'Initials': 'V', 'LastName': 'Sherina', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester, Rochester NY, United States.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Bossert', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Rochester, Rochester NY 14642, United States. Electronic address: ronald_bossert@urmc.rochester.edu.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.09.052']
607,31797203,Efficacy of early combination of local radiotherapy and GM-CSF for advanced non-small cell lung cancer treated with icotinib.,"BACKGROUND


Lung cancer is a disease that severely endangers human health. Non-small cell lung cancer (NSCLC) accounts for approximately 4/5 of lung cancers.
AIMS


To investigate the efficacy of early combination of local radiotherapy and granulocyte macrophage colony-stimulating factor (GM-CSF) for advanced NSCLC treated with icotinib.
METHODS


Forty-two patients with stage IV NSCLC complicated with EGFR gene mutation were selected and randomly divided into two groups, with 21 patients in each group. Patients in control group were treated with icotinib, and patients in experimental group were treated with icotinib combined with local radiotherapy and subcutaneous injection of GM-CSF. One-year progression free survival between two groups was compared.
RESULTS


Three months after treatment, the efficacy in experimental group was significantly better than that in control group, and objective response rate was 95.24% in experimental group, which was higher than the 71.43% in control group. Patients in experimental group had no differences in white blood cell and neutrophil, but had significantly lower carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8+ than those in control group and before treatment. There were no differences in the proportion of patients with adverse reactions between two groups. One-year progression free survival was significantly better in experimental group than in control group.
CONCLUSIONS


Early combination of local radiotherapy and GM-CSF has a significant efficacy for advanced NSCLC accounts for approximately 4/5 of lung cancers treated with icotinib, and it can improve patients' autoimmunity and lengthen progression free survival.",2020,"Patients in experimental group had no differences in white blood cell and neutrophil, but had significantly lower carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8+ than those in control group and before treatment.","['advanced non-small cell lung cancer treated with icotinib', 'Forty-two patients with stage IV NSCLC complicated with EGFR gene mutation']","['icotinib combined with local radiotherapy and subcutaneous injection of GM-CSF', 'local radiotherapy and GM-CSF', 'local radiotherapy and granulocyte macrophage colony-stimulating factor (GM-CSF', 'icotinib']","['carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8', 'white blood cell and neutrophil', 'objective response rate', 'progression free survival', 'proportion of patients with adverse reactions']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2604307', 'cui_str': '4-((3-ethynylphenyl)amino)-6,7-benzo-12-crown-4-quinazoline'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C3266992', 'cui_str': 'Epidermal growth factor receptor gene mutation'}]","[{'cui': 'C2604307', 'cui_str': '4-((3-ethynylphenyl)amino)-6,7-benzo-12-crown-4-quinazoline'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]","[{'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C1880904', 'cui_str': 'Nervous System-Specific Enolase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",42.0,0.0248504,"Patients in experimental group had no differences in white blood cell and neutrophil, but had significantly lower carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8+ than those in control group and before treatment.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Departments of Oncology, The Second People's Hospital of Yibin, No.268 Nanguang Road, Cuiping District, Yibin, 644000, Sichuan Province, China.""}, {'ForeName': 'Xinyun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Oncology, The Guizhou Provincial People's Hospital, Guiyang, Guizhou Province, China.""}, {'ForeName': 'Zepei', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, The Second People's Hospital of Yibin, No.96 North Street, Cuiping District, 644000, Yibin, Sichuan Province, China.""}, {'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Departments of Oncology, The Second People's Hospital of Yibin, No.268 Nanguang Road, Cuiping District, Yibin, 644000, Sichuan Province, China.""}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': ""Departments of Oncology, The Second People's Hospital of Yibin, No.268 Nanguang Road, Cuiping District, Yibin, 644000, Sichuan Province, China. jiayuming8djf@163.com.""}]",Irish journal of medical science,['10.1007/s11845-019-02137-x']
608,31796533,Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden.,"BACKGROUND


In squamous cell vulvar cancer, sentinel node biopsy is accepted as standard treatment in well-defined patient groups and has reduced surgical morbidity considerably. Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences.
PRIMARY OBJECTIVE


This study is primarily a pilot and feasibility trial, aiming to evaluate if the prerequisites concerning detection rate and negative predictive value are satisfactory before the implementation of a multinational trial.
STUDY HYPOTHESIS


Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort.
TRIAL DESIGN


This study is planned as a prospective, national, multicenter interventional trial. Participating patients will undergo a sentinel node biopsy in addition to an inguinofemoral lymphadenectomy.
INCLUSION AND EXCLUSION CRITERIA


Inclusion criteria: for women in group 1, a primary tumor ≥4 cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins.
PRIMARY ENDPOINT


The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure.
SAMPLE SIZE


In each of the four study arms, recruitment of 20-30 patients is planned. ESTIMATED DATES FOR COMPLETING RECRUITMENT AND PRESENTING RESULTS: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021.
TRIAL REGISTRATION


The trial is registered at ""ClinicalTrials.gov"" (ID: NCT04147780).",2020,"Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences.
","['Inclusion criteria: for women in group 1, a primary tumor ≥4\u2009cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins', 'patients with tumors of 4\u2009cm diameter or greater or with multifocal tumors']",[],['detection rate and the negative predictive value of the sentinel node procedure'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy (procedure)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1302461', 'cui_str': 'Multifocal tumor'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677944', 'cui_str': 'Signal node (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",,0.0933713,"Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Zach', 'Affiliation': 'Division for Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden diana.zach@sll.se.'}, {'ForeName': 'Paivi', 'Initials': 'P', 'LastName': 'Kannisto', 'Affiliation': 'Obstetrics and Gynecology, Clinical Sciences, Lund, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Stenström Bohlin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Gothenburg Sahlgrenska Academy, Goteborg, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Moberg', 'Affiliation': 'Obstetrics and Gynecology, Clinical Sciences, Lund, Sweden.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Kjölhede', 'Affiliation': 'Obstetrics and Gynecology, Linkopings Universitet Institutionen for klinisk och experimentell medicin, Linkoping, Sweden.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000938']
609,31203109,Parental gentle encouragement promotes shy toddlers' regulation in social contexts.,"Gentle encouragement to approach appears to reduce risk for anxiety and is commonly incorporated into parenting interventions for inhibited preschoolers, yet little is known regarding whether gentle encouragement facilitates in-the-moment regulation as shy or inhibited children face social novelty, particularly during the toddler period. The current study used a sample of 55 temperamentally shy toddlers (21-24 months old) to examine toddler regulation in novel social contexts in relation to parental gentle encouragement to engage. Contexts included low-threat social novelty (i.e., a clown and puppets) and moderately threatening social novelty (i.e., strangers). Using an experimental design, parents were randomly assigned to provide behaviors thought to represent gentle encouragement: warm responsiveness to toddler fear and encouragement of toddler autonomy, prompt to engage, both warmth and prompt, or remaining uninvolved (no-encouragement control). Relative to toddlers in the no-encouragement control condition, toddlers whose parents were instructed to provide warmth showed less fear and more engagement in moderately threatening social contexts, and toddlers whose parents were instructed to provide both warmth and prompts showed greater suppression of respiratory sinus arrhythmia in low-threat social contexts. Findings suggest that parental gentle encouragement may promote regulated responses in social contexts in shy toddlers. Encouragement of toddler autonomy and warm responsiveness to toddlers in particular may help shy toddlers to engage with, rather than withdraw from, new people.",2019,"Gentle encouragement to approach appears to reduce risk for anxiety and is commonly incorporated into parenting interventions for inhibited preschoolers, yet little is known regarding whether gentle encouragement facilitates in-the-moment regulation as shy or inhibited children face social novelty, particularly during the toddler period.",['sample of 55 temperamentally shy toddlers (21-24\u202fmonths old'],"['gentle encouragement: warm responsiveness to toddler fear and encouragement of toddler autonomy, prompt to engage, both warmth and prompt, or remaining uninvolved (no-encouragement control', 'Parental gentle encouragement']","['low-threat social novelty', 'suppression of respiratory sinus arrhythmia']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557869', 'cui_str': 'Introvert (finding)'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C3812870', 'cui_str': 'Respiratory Sinus Arrhythmia'}]",55.0,0.0139952,"Gentle encouragement to approach appears to reduce risk for anxiety and is commonly incorporated into parenting interventions for inhibited preschoolers, yet little is known regarding whether gentle encouragement facilitates in-the-moment regulation as shy or inhibited children face social novelty, particularly during the toddler period.","[{'ForeName': 'Jessica Stoltzfus', 'Initials': 'JS', 'LastName': 'Grady', 'Affiliation': 'Department of Psychology, University of the Pacific, Stockton, CA 95211, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.05.008']
610,14968738,The effect of Mulligan Traction Straight Leg Raise in participants with short hamstrings.,,2003,,['participants with short hamstrings'],['Mulligan Traction Straight Leg'],[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",[],,0.0290752,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy, Curtin University of Technology and Manual Concepts, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Anuar', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Darlow', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gurumoorthy', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ryder', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
611,32410424,[Evaluation of multimodal analgesia in treatment of avascular necrosis of femoral head with free vascularized fibular grafting].,"Objective


To prospective study the effectiveness and safety of multimodal analgesia (MA) in treatment of avascular necrosis of the femoral head with free vascularized fibular grafting (FVFG).
Methods


Sixty patients with avascular necrosis of the femoral head, who were scheduled to unilateral primary FVFG between February 2016 and December 2016 and met the selection criteria, were included in the study. All patients were allocated to two groups according to the method of random number table: MA group (  n =30) and control group (  n =30). There was no significant difference in gender, age, body mass index, side, duration and stage of avascular necrosis of the femoral head, preoperative visual analogue scale (VAS) scores under quiescent and active states, and range of motion (ROM) of hip flexion and abduction before operation (  P >0.05). The patients in the MA group were treated with MA therapy, including oral administration of celecoxib before operation, local anesthetic wound infiltration during operation, and ice compression and oral administration of celecoxib after operation. The patients in control group were only treated with patient-controlled intravenous analgesia pump. The postoperative VAS scores under quiescent and active states, ROM of hip flexion and abduction, prescription of Tramadol and adverse reaction were recorded and compared.
Results


The operations were completed successfully in both groups without obvious complications and adverse reaction. The Tramadol was used in 4 cases (13.3%) of MA group and in 11 cases (36.7%) of control group, but no significant difference was found between the two groups (  χ   2 =4.356,  P =0.072). The VAS scores under quiescent state at 6 and 24 hours postoperatively were significantly lower in MA group than in control group (  P <0.05), while VAS scores under active state at 48 hours postoperatively and on the day of discharge were significantly lower in MA group than in control group (  P <0.05). There was no significant difference in VAS score between two groups at other time points (  P >0.05). The ROM of hip flexion in MA group was better than that in control group at 1 day postoperatively and the day of discharge (  P <0.05), while no significant difference was found at 2 and 3 days postoperatively (  P >0.05). The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
Conclusion


The MA can effectively relieve the pain following FVFG and facilitate early functional exercises of the hip. The usage of opioids was also relatively fewer for MA protocol.",2020,"The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
","['avascular necrosis of femoral head with free vascularized fibular grafting', 'Sixty patients with avascular necrosis of the femoral head, who were scheduled to unilateral primary FVFG between February 2016 and December 2016 and met the selection criteria, were included in the study', 'avascular necrosis of the femoral head with free vascularized fibular grafting (FVFG']","['patient-controlled intravenous analgesia pump', 'multimodal analgesia (MA', 'Tramadol', 'celecoxib', 'MA therapy', 'multimodal analgesia']","['VAS score', 'postoperative VAS scores under quiescent and active states, ROM of hip flexion and abduction, prescription of Tramadol and adverse reaction', 'gender, age, body mass index, side, duration and stage of avascular necrosis of the femoral head, preoperative visual analogue scale (VAS) scores under quiescent and active states, and range of motion (ROM) of hip flexion and abduction before operation', 'VAS scores under quiescent state', 'ROM of hip abduction', 'VAS scores under active state', 'ROM of hip flexion']","[{'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042382', 'cui_str': 'Vascularized'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",60.0,0.0218635,"The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
","[{'ForeName': 'Difei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Sanlian', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201907023']
612,31216955,The effect of preconception counselling on health locus of control and stress in Iranian women: a randomized control trial.,"Preconception counseling can improve women's health and pregnancy outcomes. Internal health locus of control and belief in the benefits of health-promoting behaviors improve people's engagement in health-promoting behaviors. This study examined whether preconception counseling was related to stress and health locus of control. This randomized controlled trial was conducted from March to November 2016 on 152 healthy 18-35-year-old women intending to become pregnant within the next year in Iran. The intervention group received six sessions of group counseling, and the control group received only usual care. The Perceived Stress Scale, Multidimensional Health Locus of Control Scales and checklist for preconception control were completed before and after the intervention. Repeated measures ANOVA showed a significant post-intervention increase in the mean internal health locus of control ( P  < .001) and preconception control scores ( P  = .034) in the intervention group and the mean perceived stress score ( P  = .001), and chance health locus of control ( P  = .013) decreased significantly. Preconception counseling was associated with increased internal locus of control and reduced perceived stress. Preconception counselors should consider reinforcing women's internal beliefs with an emphasis on the effect of the couple's own behaviors and exposures on pregnancy and fetal outcomes.",2020,"< .001) and preconception control scores ( P  = .034) in the intervention group and the mean perceived stress score ( P  = .001), and chance health locus of control ( P  = .013) decreased significantly.","['March to November 2016 on 152 healthy 18-35-year-old women intending to become pregnant within the next year in Iran', 'Iranian women']","['Preconception counseling', 'preconception counselling', 'preconception counseling', 'six sessions of group counseling, and the control group received only usual care']","['internal locus of control and reduced perceived stress', 'preconception control scores', 'mean perceived stress score', 'Perceived Stress Scale, Multidimensional Health Locus of Control Scales and checklist for preconception control', ""women's health and pregnancy outcomes"", 'mean internal health locus of control ( P', 'chance health locus of control', 'health locus of control and stress']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0474171', 'cui_str': 'Pre-pregnancy education'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0582648', 'cui_str': 'Multidimensional health locus of control scale (assessment scale)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",152.0,0.0259526,"< .001) and preconception control scores ( P  = .034) in the intervention group and the mean perceived stress score ( P  = .001), and chance health locus of control ( P  = .013) decreased significantly.","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Babapour', 'Affiliation': 'Faculty of Psychology, Tabriz University, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Ghasemi Yngyknd', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Women & health,['10.1080/03630242.2019.1626790']
613,31206579,Vida PURA: results from a pilot randomized trial of a culturally adapted screening and brief intervention to reduce unhealthy alcohol use among Latino day laborers.,"Latino immigrant men are at increased risk for unhealthy alcohol use. Vida PURA is a culturally adapted evidence-based intervention that consists of promotores providing screening and brief intervention to reduce unhealthy alcohol use among Latino immigrant men. The purpose was to assess the efficacy of Vida PURA in a pilot randomized control trial. Participants were screened for eligibility at a day labor worker center using the Alcohol Use Disorders Identification Test (AUDIT). Those with an AUDIT score ≥ 6 (N = 121) were randomized into an intervention (N = 77) or control group (N = 44). Participants in the intervention group received a brief intervention from a promotor including personalized feedback, motivational interviewing to assess their readiness to change, and referral to services. Participants in the control group received information about local substance use treatment services. We assessed changes in AUDIT scores, drinks per drinking day, drinking days, and frequency of heavy episodic drinking at 2 and 8 weeks following the baseline survey using a mixed-effects regression model. Many men had high AUDIT scores, indicating dependence. Both the intervention and control groups reduced their alcohol-related behaviors over time, but there were no significant differences between the groups. A culturally adapted brief intervention may not be enough to significantly reduce alcohol use among Latino day laborers, especially among those that are dependent. We discuss lessons learned from this trial, including the value of community-based approaches to reaching high-risk and underserved populations.",2019,"Both the intervention and control groups reduced their alcohol-related behaviors over time, but there were no significant differences between the groups.","['Participants were screened for eligibility at a day labor worker center using the Alcohol Use Disorders Identification Test (AUDIT', 'Latino immigrant men', 'Latino day laborers']","['Vida PURA', 'culturally adapted screening and brief intervention', 'brief intervention from a promotor including personalized feedback, motivational interviewing to assess their readiness to change, and referral to services', 'information about local substance use treatment services']","['AUDIT scores, drinks per drinking day, drinking days, and frequency of heavy episodic drinking']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0240146', 'cui_str': 'Laborer (occupation)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0584065', 'cui_str': 'Referral to service (procedure)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}]",121.0,0.0243351,"Both the intervention and control groups reduced their alcohol-related behaviors over time, but there were no significant differences between the groups.","[{'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Suzanne R', 'Initials': 'SR', 'LastName': 'Doyle', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Vanessa N', 'Initials': 'VN', 'LastName': 'Torres', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Serrano', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Duran', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz071']
614,31911072,Interhemispheric facilitation of gesturing: A combined theta burst stimulation and diffusion tensor imaging study.,"BACKGROUND


Imaging studies point to a posture (finger vs. hand) and domain-specific neural basis of gestures. Furthermore, modulation of gestures by theta burst stimulation (TBS) may depend on interhemispheric disinhibition.
OBJECTIVE/HYPOTHESIS


In this randomized sham-controlled study, we hypothesized that dual site continuous TBS over left inferior frontal gyrus (IFG-L) and right inferior parietal gyrus (IPL-R) predominantly affects pantomime of finger postures. Furthermore, we predicted that dual cTBS improves imitation of hand gestures if the effect correlates with measures of callosal connectivity.
METHODS


Forty-six healthy subjects participated in this study and were targeted with one train of TBS in different experimental sessions: baseline, sham, single site IFG-L, dual IFG-L/IPL-R, single site IPL-R. Gestures were evaluated by blinded raters using the Test for Upper Limb Apraxia (TULIA) and Postural Imitation Test (PIT). Callosal connectivity was analyzed by diffusion tensor imaging (DTI).
RESULTS


Dual cTBS significantly improved TULIA total  (F [3, 28] = 4.118, p = .009), but did not affect TULIA pantomime . The beneficial effect was driven by the cTBS over IPL-R, which improved TULIA imitation  (p = .038). Furthermore, TULIA imitation  significantly correlated with the microstructure (fractional anisotropy) of the splenium (r = 0.420, p = .026), corrected for age and whole brain volume.
CONCLUSIONS


The study suggests that inhibition of IPL-R largely accounted for improved gesturing, possibly through transcallosal facilitation of IPL-L. Therefore, the findings may be relevant for the treatment of apraxic stroke patients. Gesture pantomime and postural gestures escaped the modulation by dual cTBS, suggesting a more widespread and/or variable neural representation.",2020,"RESULTS


Dual cTBS significantly improved TULIA total  (F [3, 28] = 4.118, p = .009), but did not affect TULIA pantomime .","['Forty-six healthy subjects participated in this study and were targeted with one train of TBS in different experimental sessions', 'apraxic stroke patients']","['dual site continuous TBS', 'baseline, sham, single site IFG-L, dual IFG-L/IPL-R, single site IPL-R. Gestures were evaluated by blinded raters using the Test for Upper Limb Apraxia (TULIA) and Postural Imitation Test (PIT', 'Interhemispheric facilitation of gesturing']","['TULIA total', 'Callosal connectivity', 'TULIA imitation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0003635', 'cui_str': 'Dyspraxia'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",46.0,0.0878516,"RESULTS


Dual cTBS significantly improved TULIA total  (F [3, 28] = 4.118, p = .009), but did not affect TULIA pantomime .","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vanbellingen', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Spitalstrasse 31, 6000, Luzern 16, Switzerland; Gerontechnology and Rehabilitation Group, University of Bern, 3008, Bern, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Pastore-Wapp', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Spitalstrasse 31, 6000, Luzern 16, Switzerland; Support Center for Advanced Neuroimaging (SCAN), Institute of Diagnostic and Interventional Neuroradiology, Inselspital, University Hospital, University of Bern, 3012, Bern, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Kübel', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Spitalstrasse 31, 6000, Luzern 16, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nyffeler', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Spitalstrasse 31, 6000, Luzern 16, Switzerland; Gerontechnology and Rehabilitation Group, University of Bern, 3008, Bern, Switzerland; Department of Clinical Research, University of Bern, 3000, Bern, Switzerland.'}, {'ForeName': 'Anne-Catherine', 'Initials': 'AC', 'LastName': 'Schüpfer', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Spitalstrasse 31, 6000, Luzern 16, Switzerland.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Kiefer', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), Institute of Diagnostic and Interventional Neuroradiology, Inselspital, University Hospital, University of Bern, 3012, Bern, Switzerland.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Zizlsperger', 'Affiliation': 'Cereneo Center for Neurology and Rehabilitation, Vitznau, Switzerland; Vascular Neurology and Neurorehabilitation, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Lutz', 'Affiliation': 'Cereneo Center for Neurology and Rehabilitation, Vitznau, Switzerland; Vascular Neurology and Neurorehabilitation, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Luft', 'Affiliation': 'Cereneo Center for Neurology and Rehabilitation, Vitznau, Switzerland; Vascular Neurology and Neurorehabilitation, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Walther', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, 3008, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bohlhalter', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Spitalstrasse 31, 6000, Luzern 16, Switzerland; Department of Clinical Research, University of Bern, 3000, Bern, Switzerland. Electronic address: Stephan.Bohlhalter@luks.ch.'}]",Brain stimulation,['10.1016/j.brs.2019.12.013']
615,31790015,A Pilot Study Comparing Effects of Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation in Mild Cognitive Impairment and Mild Alzheimer Disease.,"OBJECTIVE


While transcranial direct current stimulation (tDCS) can enhance aspects of memory in patients with mild cognitive impairment (MCI) and Alzheimer disease (AD), there has been wide variability in both the placement of tDCS electrodes and treatment response. This study compared the effects of bifrontal (anodal stimulation over the dorsolateral prefrontal cortices), bitemporal (anodal stimulation over the temporal cortices), and sham tDCS on cognitive performance in MCI and AD.
METHODS


Seventeen patients diagnosed with MCI or mild AD received 3 sessions of anodal tDCS (bifrontal, bitemporal, 2 mA for 20 minutes; and sham) in random order. Sessions were separated by 1 week. The Alzheimer's Disease Assessment Scale-Cognitive Word Recognition Task, Alzheimer's Disease Assessment Scale-Cognitive Word Recall Task, 2-back, and Montreal Cognitive Assessment were used to assess cognition.
RESULTS


There was a significant effect of stimulation condition on 2-back accuracy (F2,28 = 5.28 P = 0.01, ηp = 0.27), with greater improvements following bitemporal tDCS compared with both bifrontal and sham stimulations. There were no significant changes on other outcome measures following any stimulation. Adverse effects from stimulation were mild and temporary.
CONCLUSIONS


These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.",2020,These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.,"['Mild Cognitive Impairment and Mild Alzheimer Disease', 'Seventeen patients diagnosed with MCI or mild AD', 'patients with mild cognitive impairment (MCI) and Alzheimer disease (AD']","['transcranial direct current stimulation (tDCS', 'Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation', 'bifrontal (anodal stimulation', 'anodal tDCS (bifrontal, bitemporal, 2 mA for 20 minutes; and sham']","['cognitive performance', 'specific memory tasks', ""Alzheimer's Disease Assessment Scale-Cognitive Word Recognition Task, Alzheimer's Disease Assessment Scale-Cognitive Word Recall Task, 2-back, and Montreal Cognitive Assessment"", '2-back accuracy']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal (qualifier value)'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C3496286'}]",,0.145084,These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.,"[{'ForeName': 'Celina S', 'Initials': 'CS', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pharmacology & Toxicology, University of Toronto.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Adult Neurodevelopment and Geriatric Psychiatry Division, Centre for Addiction & Mental Health.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Vieira', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'From the Department of Pharmacology & Toxicology, University of Toronto.'}]",The journal of ECT,['10.1097/YCT.0000000000000639']
616,30277639,Outcomes in intermediate-risk pediatric lymphocyte-predominant Hodgkin lymphoma: A report from the Children's Oncology Group.,"PURPOSE


Optimal management of patients with intermediate-risk lymphocyte-predominant Hodgkin lymphoma (LPHL) is unclear due to their small numbers in most clinical trials. Children's Oncology Group AHOD0031, a randomized phase III trial of pediatric patients with intermediate-risk Hodgkin lymphoma (HL), included patients with LPHL. We report the outcomes of these patients and present directions for future therapeutic strategies.
PROCEDURE


Patients received two cycles of doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide (ABVE-PC) followed by response evaluation. Slow early responders were randomized to two additional ABVE-PC cycles ± two dexamethasone, etoposide, cisplatin, and cytarabine cycles and all received involved field radiotherapy (IFRT). Rapid early responders (RERs) received two additional ABVE-PC cycles. RERs with complete response (CR) were randomized to IFRT or no further therapy. RERs without CR received IFRT.
RESULTS


Ninety-six (5.6%) of 1711 patients on AHOD0031 had LPHL. Patients with LPHL were more likely to achieve RER (93.6% vs. 81.0%; P = 0.002) and CR (74.2% vs. 49.3%; P = 0.000005) following chemotherapy compared with patients with classical HL. Five-year event-free survival (EFS) was superior in patients with LPHL (92.2%) versus classical HL (83.5%) (P = 0.04), without difference in overall survival (OS). Among RERs with CR following chemotherapy (n = 33), there was no difference in EFS or OS between those randomized to receive or not receive IFRT.
CONCLUSION


Children and adolescents with intermediate-risk LPHL represent ideal candidates for response-adapted therapy based on their favorable outcomes. The majority of patients treated with the ABVE-PC backbone achieve RER with CR status and can be treated successfully without IFRT.",2018,Five-year event-free survival (EFS) was superior in patients with LPHL (92.2%) versus classical HL (83.5%),"['Children and adolescents with intermediate-risk LPHL', 'Ninety-six (5.6%) of 1711 patients on AHOD0031', 'patients with intermediate-risk lymphocyte-predominant Hodgkin lymphoma (LPHL', 'pediatric patients with intermediate-risk Hodgkin lymphoma (HL), included patients with LPHL', 'intermediate-risk pediatric lymphocyte-predominant Hodgkin lymphoma']","['dexamethasone, etoposide, cisplatin, and cytarabine cycles and all received involved field radiotherapy\xa0(IFRT', 'IFRT', 'doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide (ABVE-PC', 'chemotherapy']","['free survival (EFS', 'overall survival (OS', 'EFS or OS', 'RER']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1711.0,0.0293347,Five-year event-free survival (EFS) was superior in patients with LPHL (92.2%) versus classical HL (83.5%),"[{'ForeName': 'Lianna J', 'Initials': 'LJ', 'LastName': 'Marks', 'Affiliation': 'Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Qinglin', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': ""Children's Oncology Group Statistics & Data Center, University of Florida, Gainesville, Florida.""}, {'ForeName': 'Rizvan', 'Initials': 'R', 'LastName': 'Bush', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, California.""}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Buxton', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, California.""}, {'ForeName': 'Burton', 'Initials': 'B', 'LastName': 'Appel', 'Affiliation': 'Department of Pediatrics, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics, Roswell Park Cancer Institute, Buffalo, New York.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Schwartz', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Friedman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.'}]",Pediatric blood & cancer,['10.1002/pbc.27375']
617,31201072,An Educational Video Improves Consent in Pediatric Lumbar Puncture: A Randomized Control Trial.,"BACKGROUND


Lumbar puncture is a low-risk procedure performed on pediatric patients for a variety of indications. Parents give consent to this procedure but are often left with concerns. There are no published studies on the nature of the concerns of parents in North America and no studies examining a process to improve pediatric lumbar puncture consent. Here we identify parent concerns with lumbar puncture and determine the utility of an adjunctive educational video.
METHODS


Seventy-two patient-parent dyads were enrolled in a randomized control trial to receive standard consent with or without an educational video. A survey was provided to determine parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness, and their overall comfort with their child undergoing lumbar puncture. In addition, demographic characteristics and qualitative information about parent concerns were collected.
TRIAL REGISTRATION


NCT03677219.
RESULTS


The video resulted in significantly greater parent understanding of the procedure (P = 0.015) and perception of its safety (P = 0.021) compared with controls. Parent comfort with the procedure increased after viewing the video (P = 0.002). Parents' top three concerns were pain, infection, and neurological injury.
CONCLUSIONS


Parent concerns in pediatric lumbar puncture include pain, infection, and neurological injury, and viewing an educational video improved parent perception of understanding and safety compared with controls. In addition, there was reduced variability of responses in those who viewed the video. Thus a short educational video on a handheld device is an effective means to address parent concerns and standardize the process of pediatric lumbar puncture consent.",2019,The video resulted in significantly greater parent understanding of the procedure (P = 0.015) and perception of its safety (P = 0.021) compared with controls.,"['Seventy-two patient-parent dyads', 'Pediatric Lumbar Puncture']","['Educational Video', 'standard consent with or without an educational video']","['perception of its safety', 'pain, infection, and neurological injury']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0751792', 'cui_str': 'Injuries, Nervous System'}]",,0.0708865,The video resulted in significantly greater parent understanding of the procedure (P = 0.015) and perception of its safety (P = 0.021) compared with controls.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dunbar', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: mjdunbar@ucalgary.ca.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Paton', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Division of Pediatric Neurosurgery, Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2019.04.014']
618,31769240,Switching to Once-Daily Insulin Degludec/Insulin Aspart from Basal Insulin Improves Postprandial Glycemia in Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial.,"BACKGROUND


To explore the efficacy and safety of switching from once-daily basal insulin therapy to once-daily pre-meal injection insulin degludec/insulin aspart (IDegAsp) with respect to the glycemic control of participants with type 2 diabetes mellitus (T2DM).
METHODS


In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, participants on basal insulin therapy were switched to IDegAsp (IDegAsp group;  n =30) or continued basal insulin (Basal group;  n =29). The primary endpoint was the superiority of IDegAsp in causing changes in the daily blood glucose profile, especially post-prandial blood glucose concentration after 12 weeks.
RESULTS


Blood glucose concentrations after dinner and before bedtime were lower in the IDegAsp group, and the improvement in blood glucose before bedtime was significantly greater in the IDegAsp group than in the Basal group at 12 weeks (-1.7±3.0 mmol/L vs. 0.3±2.1 mmol/L,  P <0.05). Intriguingly, glycemic control after breakfast was not improved by IDegAsp injection before breakfast, in contrast to the favorable effect of injection before dinner on blood glucose after dinner. Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol,  P <0.05). Changes in daily insulin dose, body mass, and recorded adverse effects, including hypoglycemia, were comparable between groups.
CONCLUSION


IDegAsp was more effective than basal insulin at reducing blood glucose after dinner and before bedtime, but did not increase the incidence of hypoglycemia. Switching from basal insulin to IDegAsp does not increase the burden on the patient and positively impacts glycemic control in patients with T2DM.",2020,"Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol,  P <0.05).","['participants with type 2 diabetes mellitus (T2DM', 'Patients with Type 2 Diabetes Mellitus', 'patients with T2DM']","['basal insulin therapy were switched to IDegAsp (IDegAsp group;  n =30) or continued basal insulin', 'insulin aspart (IDegAsp', 'Switching to Once-Daily Insulin Degludec/Insulin Aspart from Basal Insulin']","['superiority of IDegAsp in causing changes in the daily blood glucose profile, especially post-prandial blood glucose concentration', 'Changes in daily insulin dose, body mass, and recorded adverse effects, including hypoglycemia', 'Postprandial Glycemia', 'incidence of hypoglycemia', 'blood glucose before bedtime', 'Blood glucose concentrations', 'Glycosylated hemoglobin', 'blood glucose']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0586684,"Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol,  P <0.05).","[{'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Oba-Yamamoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Tsuchida', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Yanagiya', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Manda', 'Affiliation': 'Manda Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}]",Diabetes & metabolism journal,['10.4093/dmj.2019.0093']
619,31490841,Antipruritic Placebo Effects by Conditioning H1-antihistamine.,"OBJECTIVE


Allergic rhinitis symptoms can be reduced by behaviorally conditioning antihistamine. It is unclear whether these findings extend to histamine-induced itch or work when participants are informed about the conditioning procedure (open-label conditioning). The current study aims to investigate the efficacy of (open-label) antipruritic behavioral conditioning for histamine-induced itch.
METHODS


Healthy participants (n = 92; 84% female) were randomized to I) an open-label conditioned, II) closed-label conditioned, III) conditioned-not-evoked control, or IV) nonconditioned control group. A two-phase conditioning paradigm was used. During acquisition, a conditioned stimulus (CS; distinctively tasting beverage) was repeatedly paired with the H1-antihistamine levocetirizine (groups I-III). During evocation, the CS was paired with placebo (I, II), or instead of the CS, water was paired with placebo (III). The nonconditioned control group (IV) received CS with placebo in both phases. Itch after histamine iontophoresis and physiological data (i.e., spirometry, heart rate, skin conductance) were assessed. Combined conditioned and combined control groups were first compared, and analyses were repeated for separate groups.
RESULTS


Marginally lower itch was reported in the combined conditioned compared with the control groups (F(1,88) = 2.10, p = .076, ηpartial = 0.02); no differences between separate groups were found. No effects on physiological data were found, except for heart rate, which reduced significantly and consistently for control groups, and less consistently for conditioned groups (group by time interaction: F(7,80) = 2.35, p = .031, ηpartial = 0.17).
CONCLUSION


Limited support was found for the efficacy of antipruritic behavioral conditioning, regardless of whether participants were informed about the conditioning procedure. The application of open-label conditioning in patient populations should be further researched.
TRIAL REGISTRATION


www.trialregister.nl; ID NTR5544.",2019,"No effects on physiological data were found, except for heart rate, which reduced significantly and consistently for control groups, and less consistently for conditioned groups (group-by-time-interaction F(7,80)=2.35, p=.031, ηpartial =.17).
","['Healthy participants (n=92, 84% female']","['H1-antihistamine levocetirizine', 'open-label conditioned, II) closed-label conditioned, III) conditioned-not-evoked control, or IV) non-conditioned control group', 'placebo', 'CS with placebo', 'histamine iontophoresis', 'antihistamine']","['heart rate', 'physiological data', 'physiological data (i.e. spirometry, heart rate, skin conductance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0214687,"No effects on physiological data were found, except for heart rate, which reduced significantly and consistently for control groups, and less consistently for conditioned groups (group-by-time-interaction F(7,80)=2.35, p=.031, ηpartial =.17).
","[{'ForeName': 'Stefanie H', 'Initials': 'SH', 'LastName': 'Meeuwis', 'Affiliation': 'From the Health, Medical and Neuropsychology Unit, Institute Psychology, Faculty of Social and Behavioural Sciences, (Meeuwis, van Middendorp, Pacheco-Lopez, Veldhuijzen, Evers), Leiden University; Leiden Institute for Brain and Cognition (Meeuwis, van Middendorp, Veldhuijzen, Evers), Leiden University Medical Center, Leiden, The Netherlands; Health Sciences Department, Campus Lerma (Pacheco-Lopez), Metropolitan Autonomous University, Lerma, Edo Mex, Mexico; and Departments of Pulmonology (Ninaber), Dermatology (Lavrijsen), and of Psychiatry (van der Wee, Evers), Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': ''}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Pacheco-Lopez', 'Affiliation': ''}, {'ForeName': 'Maarten K', 'Initials': 'MK', 'LastName': 'Ninaber', 'Affiliation': ''}, {'ForeName': 'Adriana P M', 'Initials': 'APM', 'LastName': 'Lavrijsen', 'Affiliation': ''}, {'ForeName': 'Nic', 'Initials': 'N', 'LastName': 'van der Wee', 'Affiliation': ''}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': ''}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000743']
620,31783028,"The safety and efficacy of 2% vitamin C solution spray for relief of mucosal irritation caused by Lugol chromoendoscopy: a multicenter, randomized, double-blind, parallel trial.","BACKGROUND AND AIMS


Lugol chromoendoscopy facilitates endoscopic visualization of esophageal dysplasia and carcinoma. Vitamin C solution (VCS) can theoretically neutralize free iodine, which causes mucosal irritation. The aim was to assess the safety and efficacy of VCS for relieving adverse symptoms caused by Lugol iodine staining.
METHODS


Two hundred forty eligible patients were randomized to receive 20 mL of normal saline solution (NS), 5% sodium thiosulfate solution (STS), or 2% VCS after spraying 10 mL of 2% Lugol iodine solution on the mid-distal esophagus. The primary endpoints were statistically significant reductions in acute and late adverse symptom severity scores. The secondary endpoint was the discoloration effect on esophageal brown iodine-stained mucosa.
RESULTS


Spraying both VCS and STS similarly decreased the severity scores of acute (NS vs VCS = 2.58 vs 1.61, P = .040; VCS vs STS = 1.61 vs 1.89, P > .999) and late (NS vs VCS = 1.70 vs 0.91, P = .002; VCS vs STS = 0.91 vs 1.38; P = .212) adverse symptoms after Lugol chromoendoscopy compared with spraying NS. Compared with STS spray, VCS spray alleviated acute acid regurgitation or heartburn (33% vs 15%, P = .017) and late retrosternal discomfort or pain (21% vs 9%, P = .027). Moreover, compared with spraying NS, spraying VCS quickly discolored the iodine-stained mucosa, with a better decolorization score (2.26 vs 3.56, P = .000), and the effects of fading iodine dye were similar between VCS and STS (3.56 vs 3.59, P = .908).
CONCLUSIONS


VCS can reduce mucosal irritation symptoms induced by Lugol chromoendoscopy and can be routinely recommended. (Chinese Clinical Trial Registry number: ChiCTR1900022000.).",2020,"RESULTS


Spraying both VCS and STS similarly decreased the severity scores of the acute (NS vs VCS = 2.58 vs 1.61, P = 0.040; VCS vs STS = 1.61",['Two hundred forty eligible subjects'],"['STS spray, VCS spray', 'vitamin C solution spray', 'VCS', '20 mL of normal saline solution (NS), 5% sodium thiosulfate solution (STS), or 2% VCS after spraying 10 mL of 2% Lugol iodine solution', 'Vitamin C solution (VCS']","['discoloration effect on esophageal brown iodine-stained mucosa', 'acute acid regurgitation or heartburn', 'acute and late adverse symptom severity scores', 'decolorization score', 'mucosal irritation', 'late retrosternal discomfort or pain', 'effects of fading iodine dye', 'severity scores', 'mucosal irritation symptoms', 'safety and efficacy', 'adverse symptoms']","[{'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C2350033', 'cui_str': 'sodium thiosulfate (USAN)'}, {'cui': 'C0065234', 'cui_str': 'potassium triiodide'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0857400', 'cui_str': 'Retrosternal discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013343', 'cui_str': 'Dyes'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0587867', 'cui_str': 'Irritation symptom (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",240.0,0.481501,"RESULTS


Spraying both VCS and STS similarly decreased the severity scores of the acute (NS vs VCS = 2.58 vs 1.61, P = 0.040; VCS vs STS = 1.61","[{'ForeName': 'Duochen', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Jinhu County People's Hospital, Huaian, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhan', 'Affiliation': ""Department of Gastroenterology and Hepatology, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Keting', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Yinghong', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'First Clinical Medical College of Nanjing Medical University, Nanjing, China; Endoscopic Center, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology and Hepatology, Jinhu County People's Hospital, Huaian, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology and Hepatology, Jinhu County People's Hospital, Huaian, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Veterans Affairs Boston Healthcare System and Harvard Medical School, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.11.028']
621,31189334,"Scandcleft Project, Trial 1: Comparison of Speech Outcome in Relation to Timing of Hard Palate Closure in 5-Year-Olds With UCLP.","OBJECTIVE


To compare in-depth speech results in Scandcleft Trial 1 as well as reference data from peers without cleft palate (CP).
DESIGN


A prospective randomized clinical trial.
SETTING


A Danish and a Swedish CP center.
PARTICIPANTS


143 of 148 randomized 5-year-olds with unilateral cleft lip and palate. All received lip and velum closure at 4 months, and hard palate closure at 12 months (arm A) or 36 months (arm B).
MAIN OUTCOME MEASURES


A composite measure based on velopharyngeal competence (VPC) or velopharyngeal incompetence (VPI), an overall assessment of VPC from connected speech (VPC-Rate), Percentage of Consonants Correct (PCC-score), and consonant errors. Speech therapy visits, average hearing thresholds, and secondary pharyngeal surgeries documented burden of treatment.
RESULTS


Across the trial, 61.5% demonstrated VPC and 38.5% VPI. Twenty-two percent of participants achieved age appropriate PCC-scores. There were no statistically significant differences between arms or centers for these measures. In the Danish center, arm B: achieved lower PCC-scores ( P  = .01); obtained PCC-scores without s-errors below 79% ( P  = .002); produced ≥3 active oral cleft speech characteristics ( P  = .004) than arm A. In both centers, arm B attended more speech visits.
CONCLUSIONS


At age 5, differences between centers and treatment arms were not statistically significant for VPC/VPI, but consonant proficiency differed between treatment arms in the Danish center. Poor speech outcomes were seen for both treatment arms. Variations between centers were observed. As the Swedish center had few participants, intercenter comparisons should be interpreted with caution.",2019,"In the Danish center, arm B: achieved lower PCC-scores ( P  = .01); obtained PCC-scores without s-errors below 79% ( P  = .002); produced ≥3 active oral cleft speech characteristics ( P  = .004) than arm A.","['A Danish and a Swedish CP center', '143 of 148 randomized 5-year-olds with unilateral cleft lip and palate', 'peers without cleft palate (CP']",['UCLP'],"['velopharyngeal competence (VPC) or velopharyngeal incompetence (VPI), an overall assessment of VPC from connected speech (VPC-Rate), Percentage of Consonants Correct (PCC-score), and consonant errors', 'lower PCC-scores', 'Poor speech outcomes', 'VPC/VPI', 'age appropriate PCC-scores', '≥3 active oral cleft speech characteristics']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}]",[],"[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0042454', 'cui_str': 'Velopharyngeal Incompetence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",,0.17985,"In the Danish center, arm B: achieved lower PCC-scores ( P  = .01); obtained PCC-scores without s-errors below 79% ( P  = .002); produced ≥3 active oral cleft speech characteristics ( P  = .004) than arm A.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lohmander', 'Affiliation': 'Division of Speech and Language Pathology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Persson', 'Affiliation': 'Speech and Language Pathology Unit, Institute of Neuroscience and Physiology, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Kisling-Møller', 'Affiliation': 'Cleft Palate Center, Aarhus, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Havstam', 'Affiliation': 'Division of Speech and Language Pathology, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Elander', 'Affiliation': 'University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'University Hospital of Copenhagen, Copenhagen, Denmark.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619854632']
622,31187863,Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity.,"BACKGROUND


Dietary DHA intake among US toddlers is low. Healthy physical growth is an important objective for the clinical care of children born preterm.
OBJECTIVES


The aim of the trial was to examine the effects of supplementing toddlers born preterm with DHA and arachidonic acid (AA) for 180 d on growth and adiposity.
METHODS


Omega Tots, a randomized placebo-controlled trial, was conducted between April 2012 and March 2017. Children born at <35 wk gestation who were 10-16 mo in corrected age were assigned to receive daily oral supplements of DHA and AA (200 mg each, ""DHA + AA"") or corn oil (placebo) for 180 d. Prespecified secondary outcomes included weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage, which were measured at baseline and trial completion. Mixed-effects regression was used to compare the change in outcomes between the DHA + AA and placebo groups, controlling for baseline values.
RESULTS


Among 377 children included in the analysis (median corrected age = 15.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end. No statistically significant differences between the DHA + AA and placebo groups in growth or adiposity outcomes were observed. For instance, the change in weight-for-age z scores was 0.1 for the DHA + AA group and 0.0 for the placebo group (effect size = 0.01, P = 0.99). However, post-hoc subgroup analyses revealed a statistically significant interaction between treatment group and sex, suggesting somewhat slower linear growth for females assigned to the DHA + AA group compared with the placebo group.
CONCLUSIONS


Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo. If DHA supplementation is implemented after the first year of life, it can be expected to have no effect on short-term growth or adiposity. This trial is registered with clinicaltrials.gov as NCT02199808.",2019,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","['Toddlers Born Preterm', 'supplementing toddlers born preterm with DHA and', 'children born preterm', 'Children born at <35 wk gestation who were 10-16 mo in corrected age', '377 children included in the analysis (median corrected age\xa0=\xa015.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end', 'April 2012 and March 2017']","['daily oral supplements of DHA and AA (200 mg each, ""DHA\xa0+\xa0AA"") or corn oil (placebo', 'arachidonic acid (AA', 'placebo', 'Docosahexaenoic and Arachidonic Acid Supplementation']","['weight-for-age z scores', 'growth or adiposity outcomes', 'weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage', 'growth or adiposity']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",377.0,0.675973,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","[{'ForeName': 'Taniqua T', 'Initials': 'TT', 'LastName': 'Ingol', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': 'Schoenbaum Family Center and Crane Center for Early Childhood Research and Policy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Keith O', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Psychology, Alberta Children's Hospital Research Institute, and Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Nelin', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Sheppard', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}]",The Journal of nutrition,['10.1093/jn/nxz115']
623,32410425,[Effect of different use time of intermittent pneumatic compression on the incidence of deep vein thrombosis of lower extremities after arthroplasty].,"Objective


To investigate the effect of different use time of intermittent pneumatic compression (IPC) on the incidence of deep vein thrombosis (DVT) of lower extremities after arthroplasty.
Methods


Between October 2018 and February 2019, 94 patients who planned to undergo unilateral total hip or knee arthroplsty and met the selection criteria were randomly divided into a control group (47 cases) and a trial group (47 cases). There was no significant difference in gender, age, surgical site, and surgical reason between the two groups (  P >0.05). After returning to the ward, all patients were treated with IPC. And the IPC was used until 9:00 pm on the day after operation in the trial group and until 8:00 am the next day after operation in the control group. The levels of hemoglobin, platelet count, D-dimer, hospital stay, treatment costs, patients' satisfaction with IPC, the parameters of thromboelastrography [kinetics (K value), freezing angle (α angle), reaction time (R value), maximum amplitude (MA value)], visual analogue scale (VAS) score, circumference difference of calf before and after operation, Pittsburgh sleep assessment score, and the incidence of DVT of lower limbs were recorded and compared between the two groups.
Results


The K value and D-dimer before operation were significant different between the two groups (  P <0.05). There was no significant difference in pre- and post-operative hemoglobin, platelet count, and the other parameters of thromboelastography between the two groups (  P >0.05). There was no significant difference in pre- and post-operative VAS scores and post-operative circumference difference of calf between the two groups (  P >0.05). The sleep assessment score of the trial group at 1 day after operation was significant lower than that of the control group (  t =2.107,  P =0.038). There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05). There was 1 case (2.1%) of DVT, 3 cases (6.4%) of intermuscular venous thrombosis, and 1 case (2.1%) of infection in the trial group, and 2 cases (4.3%), 4 cases (8.5%), and 0 (0) in the control group. The differences were not significant (  P >0.05). After the completion of postoperative IPC treatment, the satisfaction rates of using IPC were 89.4%(42/47) in the trial group and 70.2% (33/47) in the control group, and the difference was not significant (  χ   2 =0.097,  P =0.104).
Conclusion


IPC using for a short period of time after arthroplasty do not increase the degrees of the pain and the swelling of calf; it can effectively prevent DVT of the lower extremity, improve the quality of sleep in patients, and is good for the limbs rehabilitation.",2020,There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05).,"['deep vein thrombosis (DVT) of lower extremities after arthroplasty', 'deep vein thrombosis of lower extremities after arthroplasty', 'Methods\n\n\nBetween October 2018 and February 2019, 94 patients who planned to undergo unilateral total hip or knee arthroplsty and met the selection criteria']","['intermittent pneumatic compression (IPC', 'intermittent pneumatic compression', 'IPC']","['pre- and post-operative VAS scores and post-operative circumference difference of calf', 'quality of sleep', 'gender, age, surgical site, and surgical reason', 'satisfaction rates of using IPC', 'hospital stay and treatment costs', 'K value and D-dimer before operation', 'sleep assessment score', ""levels of hemoglobin, platelet count, D-dimer, hospital stay, treatment costs, patients' satisfaction with IPC, the parameters of thromboelastrography [kinetics (K value), freezing angle (α angle), reaction time (R value), maximum amplitude (MA value)], visual analogue scale (VAS) score, circumference difference of calf before and after operation, Pittsburgh sleep assessment score, and the incidence of DVT of lower limbs"", 'pre- and post-operative hemoglobin, platelet count, and the other parameters of thromboelastography', 'intermuscular venous thrombosis']","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",,0.0215101,There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05).,"[{'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Duan', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Dengbin', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201907095']
624,31748427,Changeover Trial of Febuxostat and Topiroxostat for Hyperuricemia with Cardiovascular Disease: Sub-Analysis for Chronic Kidney Disease (TROFEO CKD Trial).,"BACKGROUND


The TROFEO trial demonstrated that febuxostat causes greater and more rapid reduction of serum uric acid (s-UA) than topiroxostat. We compared these drugs in patients with chronic kidney disease (CKD) by sub-analysis of the TROFEO trial.
METHODS


This sub-analysis targeted patients with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m 2 . The primary endpoint was the s-UA level. Secondary endpoints included creatinine, eGFR, urinary albumin, cystatin-C, oxidized low-density lipoprotein (Ox-LDL), eicosapentaenoic acid/arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein, and B-type natriuretic peptide (BNP).
RESULTS


There was no significant difference of s-UA between the two groups either before or after treatment. However, s-UA did not exceed 6.0 mg/dL in febuxostat group during the study period, but it exceeded this level in seven patients from topiroxostat group, with the number being significantly higher in topiroxostat group. Serum creatinine (s-Cr) and eGFR were significantly better after 6 months of febuxostat treatment compared with topiroxostat Cystatin-C was significantly lower after 6 months of febuxostat treatment compared with topiroxostat. The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
CONCLUSION


Febuxostat had stronger renoprotective and antioxidant effects than topiroxostat in patients with hyperuricemia and CKD.",2020,"The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
","['patients with an estimated glomerular filtration rate (eGFR) ≤60', 'Hyperuricemia with Cardiovascular Disease', 'patients with hyperuricemia and CKD', 'patients with chronic kidney disease (CKD) by sub-analysis of the TROFEO trial']","['febuxostat', 'Febuxostat', 'Febuxostat and Topiroxostat']","['s-UA', 'renoprotective and antioxidant effects', 'Serum creatinine (s-Cr) and eGFR', 'Ox-LDL', 'creatinine, eGFR, urinary albumin, cystatin-C, oxidized low-density lipoprotein (Ox-LDL), eicosapentaenoic acid/arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein, and B-type natriuretic peptide (BNP', 's-UA level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3811844'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C4049065', 'cui_str': 'topiroxostat'}]","[{'cui': 'C3179302', 'cui_str': 'Anti-Oxidant Effects'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.121033,"The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sezai', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Unosawa', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Taoka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Osaka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisakuni', 'Initials': 'H', 'LastName': 'Sekino', 'Affiliation': 'Department of Cardiovascular Surgery, Sekino Hospital, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.19-00162']
625,31165374,Sharing in care: engaging care partners in the care and communication of breast cancer patients.,"PURPOSE


Family is often overlooked in cancer care. We developed a patient-family agenda setting intervention to engage family in cancer care communication.
METHODS


We conducted a pilot randomized controlled trial (NCT03283553) of patients on active treatment for breast cancer and their family ""care partner."" Intervention dyads (n = 69) completed a self-administered checklist to clarify care partner roles, establish a shared visit agenda, and facilitate MyChart patient portal access. Control dyads (n = 63) received usual care. We assessed intervention acceptability and initial effects from post-visit surveys and MyChart utilization at 6 weeks.
RESULTS


At baseline, most patients (89.4%) but few care partners (1.5%) were registered for MyChart. Most patients (79.4%) wanted their care partner to have access to their records and 39.4% of care partners reported accessing MyChart. In completing the checklist, patients and care partners endorsed active communication roles for the care partner and identified a similar visit agenda: most (> 90%) reported the checklist was easy, useful, and recommended it to others. At 6 weeks, intervention (vs control) care partners were more likely to be registered for MyChart (75.4% vs 1.6%; p < 0.001), to have logged in (43.5% vs 0%; p < 0.001) and viewed clinical notes (30.4% vs 0%; p < 0.001), but were no more likely to exchange direct messages with clinicians (1.5% vs 0%; p = 0.175). No differences in patients' MyChart use were observed, but intervention patients more often viewed clinical notes (50.7% vs 9.5%; p < 0.001).
CONCLUSIONS


A patient-family agenda setting intervention was acceptable and affected online practices of cancer patients and care partners.",2019,"No differences in patients' MyChart use were observed, but intervention patients more often viewed clinical notes (50.7% vs 9.5%; p < 0.001).
","['patients on active treatment for breast cancer and their family ""care partner', 'cancer patients and care partners', 'breast cancer patients']","[' Intervention dyads (n\u2009=\u200969) completed a self-administered checklist to clarify care partner roles, establish a shared visit agenda, and facilitate MyChart patient portal access', 'usual care']",['viewed clinical notes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0418658,"No differences in patients' MyChart use were observed, but intervention patients more often viewed clinical notes (50.7% vs 9.5%; p < 0.001).
","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA. jwolff2@jhu.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Aufill', 'Affiliation': 'The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Echavarria', 'Affiliation': 'The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'JaAlah-Ai', 'Initials': 'JA', 'LastName': 'Heughan', 'Affiliation': 'The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kimberley T', 'Initials': 'KT', 'LastName': 'Lee', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Roisin M', 'Initials': 'RM', 'LastName': 'Connolly', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Fetting', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Jelovac', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Papathakis', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Riley', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Stearns', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Thorner', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Zafman', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Howard P', 'Initials': 'HP', 'LastName': 'Levy', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sydney M', 'Initials': 'SM', 'LastName': 'Dy', 'Affiliation': 'The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA. awolff@jhmi.edu.'}]",Breast cancer research and treatment,['10.1007/s10549-019-05306-9']
626,31748169,Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial.,"BACKGROUND


The multicentre, international ADDITION-Europe study investigated the effect of promoting intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes over 5 years. Here we report the results of a post-hoc 10-year follow-up analysis of ADDITION-Europe to establish whether differences in treatment and cardiovascular risk factors have been maintained and to assess effects on cardiovascular outcomes.
METHODS


As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands) were randomly assigned by computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment. Population-based stepwise screening programmes among people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes. Allocation was concealed from patients. Following the 5-year follow-up, no attempts were made to maintain differences in treatment between study groups. In this report, we did a post-hoc analysis of cardiovascular and renal outcomes over 10 years following randomisation, including a 5 years post-intervention follow-up. As in the original trial, the primary endpoint was a composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation, up to Dec 31, 2014. Analyses were based on the intention-to-treat principle. ADDITION-Europe is registered with ClinicalTrials.gov, NCT00237549.
FINDINGS


343 general practices were randomly assigned to routine diabetes care (n=176) or intensive multifactorial treatment (n=167). 317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006. Of the 3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis. Mean duration of follow-up was 9·61 years (SD 2·99). Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up. By 10 years, 443 participants had a first cardiovascular event and 465 died. There was no significant difference between groups in the incidence of the primary composite outcome (16·1 per 1000 person-years in the routine care group vs 14·3 per 1000 person-years in the intensive treatment group; hazard ratio [HR] 0·87, 95% CI 0·73-1·04; p=0·14) or all-cause mortality (15·6 vs 14·3 per 1000 person-years; HR 0·90, 0·76-1·07).
INTERPRETATION


Sustained reductions in glycaemia and related cardiovascular risk factors over 10 years among people with screen-detected diabetes managed in primary care are achievable. The differences in prescribed treatment and cardiovascular risk factors in the 5 years following diagnosis were not maintained at 10 years, and the difference in cardiovascular events and mortality remained non-significant.
FUNDING


National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Novo Nordisk, Novo Nordisk Foundation, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Wellcome Trust, UK Medical Research Council, UK National Institute for Health Research, UK National Health Service, Merck, Julius Center for Health Sciences and Primary Care, UK Department of Health, and Nuts-OHRA.",2019,"Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up.","['people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes', 'people with screen-detected type 2 diabetes over 5 years', '343 general practices', 'individuals with screen-detected type 2 diabetes in primary care', '3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis', '443 participants had a first cardiovascular event and 465 died', 'As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands', '317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006']","['routine diabetes care (n=176) or intensive multifactorial treatment', 'computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment', 'intensive multifactorial therapy']","['Mean duration', 'cardiovascular risk factors', 'bodyweight, HbA 1c , blood pressure, and cholesterol', 'cardiovascular events and mortality', 'composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0002694', 'cui_str': 'Amputation, Traumatic'}]",443.0,0.0983433,"Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up.","[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Guy E H M', 'Initials': 'GEHM', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Witte', 'Affiliation': 'Section of Epidemiology, Aarhus University, Aarhus, Denmark; Department of Public Health, Aarhus University, Aarhus, Denmark; Danish Diabetes Academy, Odense, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritzen', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Irving', 'Affiliation': 'Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Rimke C', 'Initials': 'RC', 'LastName': 'Vos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands; Department of Public Health and Primary Care, Leiden University Medical Center, Campus The Hague, The Hague, Netherlands.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Annelli', 'Initials': 'A', 'LastName': 'Sandbæk', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark; Steno Diabetes Center, Aarhus University Hospital, Aarhus, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30349-3']
627,31749128,"Putative Probiotic Strains Isolated from Kefir Improve Gastrointestinal Health Parameters in Adults: a Randomized, Single-Blind, Placebo-Controlled Study.","The dairy products remain as the largest reservoir for isolation of probiotic microorganisms. While probiotics have been immensely reported to exert various health benefits, it is also a common notion that these health potentials are strain and host dependent, leading to the need of more human evidence based on specific strains, health targets, and populations. This randomized, single-blind, and placebo-controlled human study aimed to evaluate the potential benefits of putative probiotic strains isolated from kefir on gastrointestinal parameters in fifty-six healthy adults. The consumption of AB-kefir (Bifidobacterium longum, Lactobacillus acidophilus, L. fermentum, L. helveticus, L. paracasei, L. rhamnosus, and Streptococcus thermophiles; total 10 log CFU/sachet) daily for 3 week reduced symptoms of abdominal pain, bloating (P = 0.014), and appetite (P = 0.041) in male subjects as compared to the control. Gut microbiota distribution profiles were shifted upon consumption of AB-kefir compared to baseline, where the abundance of bifidobacteria was increased in male subjects and maintained upon cessation of AB-kefir consumption. The consumption of AB-kefir also increased gastrointestinal abundance of total anaerobes (P = 0.038) and total bacterial (P = 0.049) in female subjects compared to the control after 3 weeks. Our results indicated that AB-kefir could potentially be developed as a natural strategy to improve gastrointestinal functions in adults.",2020,The consumption of AB-kefir also increased gastrointestinal abundance of total anaerobes (P = 0.038) and total bacterial (P = 0.049) in female subjects compared to the control after 3 weeks.,"['adults', 'Adults', 'male subjects', 'fifty-six healthy adults']","['placebo', 'Placebo', 'putative probiotic strains isolated from kefir']","['appetite', 'abundance of bifidobacteria', 'total bacterial', 'symptoms of abdominal pain, bloating', 'gastrointestinal functions', 'gastrointestinal abundance of total anaerobes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0524649', 'cui_str': 'Kefir'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0004613', 'cui_str': 'Bacteria, Anaerobic'}]",56.0,0.025813,The consumption of AB-kefir also increased gastrointestinal abundance of total anaerobes (P = 0.038) and total bacterial (P = 0.049) in female subjects compared to the control after 3 weeks.,"[{'ForeName': 'Ming-Cheng', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ahmad Imran', 'Initials': 'AI', 'LastName': 'Zaydi', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, 11800, Penang, Malaysia.'}, {'ForeName': 'Wei-Hung', 'Initials': 'WH', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Jin-Seng', 'Initials': 'JS', 'LastName': 'Lin', 'Affiliation': 'Culture Collection and Research Institute, SYNBIO TECH INC., Kaohsiung, Taiwan.'}, {'ForeName': 'Min-Tze', 'Initials': 'MT', 'LastName': 'Liong', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, 11800, Penang, Malaysia. mintze.liong@usm.my.'}, {'ForeName': 'Jiunn-Jong', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Department of Biotechnology and Laboratory Science in Medicine, School of Biomedical Science and Engineering, National Yang Ming University, Taipei, Taiwan. jjwu1019@ym.edu.tw.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-019-09615-9']
628,31152658,The Degree of Aminoacidemia after Dairy Protein Ingestion Does Not Modulate the Postexercise Anabolic Response in Young Men: A Randomized Controlled Trial.,"BACKGROUND


Resistance exercise and dietary protein stimulate muscle protein synthesis (MPS). The rate at which proteins are digested and absorbed into circulation alters peak plasma amino acid concentrations and may modulate postexercise MPS. A novel mineral modified milk protein concentrate (mMPC), with identical amino acid composition to standard milk protein concentrate (MPC), was formulated to induce rapid aminoacidemia.
OBJECTIVES


The aim of this study was to determine whether rapid aminoacidemia and greater peak essential amino acid (EAA) concentrations induced by mMPC would stimulate greater postresistance exercise MPS, anabolic signaling, and ribosome biogenesis compared to standard dairy proteins, which induce a small but sustained plasma essential aminoacidemia.
METHODS


Thirty healthy young men (22.5 ± 3.0 y; BMI 23.8 ± 2.7 kg/m2) received primed constant infusions of l-[ring-13C6]-phenylalanine and completed 3 sets of leg presses and leg extensions at 80% of 1 repetition. Afterwards, participants were randomly assigned in a double-blind fashion to consume 25 g mMPC, MPC, or calcium caseinate (CAS). Vastus lateralis biopsies were collected at rest, and 2 and 4 h post exercise.
RESULTS


Plasma EAA concentrations, including leucine, were 19.2-26.6% greater in the mMPC group 45-90 min post ingestion than in MPC and CAS groups (P < 0.001). Myofibrillar fractional synthetic rate from baseline to 4 h was increased by 82.6 ± 64.8%, 137.8 ± 72.1%, and 140.6 ± 52.4% in the MPC, mMPC, and CAS groups, respectively, with no difference between groups (P = 0.548). Phosphorylation of anabolic signaling targets (P70S6KThr389, P70S6KThr421/Ser424, RPS6Ser235/236, RPS6Ser240/244, P90RSKSer380, 4EBP1) were elevated by <3-fold at both 2 and 4 h post exercise in all groups (P < 0.05).
CONCLUSIONS


The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men. This trial was registered at http://www.anzctr.org.au/ as ACTRN12617000393358.",2019,The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men.,"['Young Men', 'young men', 'Thirty healthy young men (22.5\xa0±']","['primed constant infusions of l-[ring-13C6]-phenylalanine', 'double-blind fashion to consume 25 g mMPC, MPC, or calcium caseinate (CAS', 'Resistance exercise and dietary protein', 'novel mineral modified milk protein concentrate (mMPC), with identical amino acid composition to standard milk protein concentrate (MPC', 'mMPC']","['Plasma EAA concentrations, including leucine', 'Myofibrillar fractional synthetic rate', 'Degree of Aminoacidemia after Dairy Protein Ingestion', 'Postexercise Anabolic Response']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0639214', 'cui_str': 'MMPC'}, {'cui': 'C0301465', 'cui_str': 'Calcium caseinate (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0268457', 'cui_str': 'Aminoacidemia'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.312324,The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men.,"[{'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Chan', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': ""D'Souza"", 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Beals', 'Affiliation': 'Division of Nutritional Sciences.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zeng', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Utpal', 'Initials': 'U', 'LastName': 'Prodhan', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Fanning', 'Affiliation': 'Fonterra Research and Development Centre, Palmerston North, New Zealand.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Roy J. Carver Biotechnology Center.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Cameron J', 'Initials': 'CJ', 'LastName': 'Mitchell', 'Affiliation': 'Liggins Institute.'}]",The Journal of nutrition,['10.1093/jn/nxz099']
629,31162372,Spontaneous Breathing Trial for Prediction of Extubation Success in Pediatric Patients Following Congenital Heart Surgery: A Randomized Controlled Trial.,"OBJECTIVES


To evaluate the usefulness of a spontaneous breathing trial for predicting extubation success in pediatric patients in the postoperative period after cardiac surgery compared with a physician-led weaning.
STUDY DESIGN


Randomized, controlled trial.
SETTING


PICU of a tertiary-care university hospital.
PATIENTS


A population of pediatric patients following cardiac surgery for congenital heart disease.
INTERVENTIONS


Patients on mechanical ventilation for more than 12 hours after surgery who were considered ready for weaning were randomized to the spontaneous breathing trial group or the control group. The spontaneous breathing trial was performed on continuous positive airway pressure with the pressure support of 10 cmH2O, the positive end-expiratory pressure of 5 cmH2O, and the fraction of inspired oxygen less than or equal to 0.5 for 2 hours. Patients in the control group underwent ventilator weaning according to clinical judgment.
MEASUREMENTS AND MAIN RESULTS


The primary endpoint was extubation success defined as no need for reintubation within 48 hours after extubation. Secondary outcomes were PICU length of stay, hospital length of stay, occurrence rate of ventilator-associated pneumonia, and mortality. One hundred and ten patients with the median age of 8 months were included in the study: 56 were assigned to the spontaneous breathing trial group and 54 were assigned to the control group. Demographic and clinical data and Risk Adjustment for Congenital Heart Surgery-1 classification were similar in both groups. Patients undergoing the spontaneous breathing trial had greater extubation success (83% vs 68%, p = 0.02) and shorter PICU length of stay (median 85 vs 367 hr, p < 0.0001) compared with the control group, respectively. There was no significant difference between groups in hospital length of stay, occurrence rate of ventilator-associated pneumonia, and mortality.
CONCLUSIONS


Pediatric patients with congenital heart disease undergoing the spontaneous breathing trial postoperatively had greater extubation success and shorter PICU length of stay compared with those weaned according to clinical judgment.",2019,"There was no significant difference between groups in hospital length of stay, occurrence rate of ventilator-associated pneumonia, and mortality.
","['pediatric patients in the postoperative period after cardiac surgery compared with a physician-led weaning', 'Pediatric patients with congenital heart disease', 'PICU of a tertiary-care university hospital', 'Pediatric Patients', 'Following Congenital Heart Surgery', 'One hundred ten patients with the median age of 8 months were included in the study: 56', 'A population of pediatric patients following cardiac surgery for congenital heart disease']","['Patients on mechanical ventilation', 'spontaneous breathing trial', 'ventilator weaning']","['extubation success and shorter PICU length of stay', 'hospital length of stay, occurrence rate of ventilator-associated pneumonia, and mortality', 'extubation success', 'shorter PICU length of stay', 'PICU length of stay, hospital length of stay, occurrence rate of ventilator-associated pneumonia, and mortality', 'extubation success defined as no need for reintubation within 48 hours after extubation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C1112479', 'cui_str': 'Respirator Weaning'}]","[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}]",110.0,0.262699,"There was no significant difference between groups in hospital length of stay, occurrence rate of ventilator-associated pneumonia, and mortality.
","[{'ForeName': 'Felipe V', 'Initials': 'FV', 'LastName': 'Ferreira', 'Affiliation': 'All authors: Department of Pediatrics, Division of Pediatric Critical Care, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Sugo', 'Affiliation': ''}, {'ForeName': 'Davi C', 'Initials': 'DC', 'LastName': 'Aragon', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': ''}, {'ForeName': 'Ana P C P', 'Initials': 'APCP', 'LastName': 'Carlotti', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002006']
630,31754238,Exercise effects on arterial stiffness and heart health in children with excess weight: The SMART RCT.,"INTRODUCTION


Childhood obesity and inactivity are associated with cardiovascular risk. Evidence is limited for exercise effects on arterial health in children.
METHODS


One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity) were randomized to an 8-month daily after-school aerobic exercise program (40 min/day, n = 90) or a sedentary control condition (n = 85). Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein were measured at baseline and posttest (8 months). Adiposity, fitness, and BP were measured again at follow-up, 8-12 months later. Intent-to-treat analyses were conducted using mixed models.
RESULTS


The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161 ± 7 beats/min). Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001). There was no group × time effect on other outcomes at 8 months, or on any outcomes at follow-up. The change in PWV at 8 months correlated with changes in insulin and insulin resistance (both r = 0.32), diastolic BP (r = 0.24), BMI (r = 0.22), and adiposity (r = 0.18).
CONCLUSIONS


Eight months of aerobic exercise training improved fitness, adiposity, and HDL-cholesterol levels, but did not reduce arterial stiffness in children with excess weight. PWV improved as a function of insulin resistance, BP, BMI, and adiposity. Weight loss may be required to improve arterial stiffness. Exercise benefits waned after discontinuing the program.",2020,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","['children', 'children with excess weight', 'The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161\u2009±\u20097 beats/min', 'One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity']","['school aerobic exercise program (40\u2009min/day, n\u2009=\u200990) or a sedentary control condition', 'aerobic exercise training']","['insulin and insulin resistance', 'Adiposity, fitness, and BP', 'arterial stiffness', 'function of insulin resistance, BP, BMI, and adiposity', 'fitness, adiposity, and HDL-cholesterol levels', 'Weight loss', 'HDL-cholesterol', 'adiposity', 'arterial stiffness and heart health', 'diastolic BP', 'BMI', 'Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein', 'change in PWV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",175.0,0.0968893,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA. katie.davis@augusta.edu.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Cardiology, Medicine, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Norman K', 'Initials': 'NK', 'LastName': 'Pollock', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Population Health Sciences, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Armento', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bassali', 'Affiliation': 'Pediatrics, MCG, Augusta University, Augusta, GA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0482-1']
631,31124424,Comparison of the Mean Minimum Dose of Bolus Oxytocin for Proper Uterine Contraction during Cesarean Section.,"BACKGROUND


Cesarean section is the most common midwifery operation. The aim of this study is to determine the mean minimum dose of bolus oxytocin for proper uterine contraction during cesarean section.
METHODS


Patients were divided into two groups: elective cesarean section (n=41) and cesarean section due to difficulty in labor (n=42 patients). Patients underwent spinal anesthesia and oxytocin infusion was begun at 30 drops per minute (20 units of oxytocin per 1000 cc serum), and was also administered as a half-dose in cc to achieve effective contraction of the uterus. Meanwhile, the information of patients including systolic and diastolic blood pressure (SBP and DBP), heart rate and amount of bleeding during the operation was recorded in a questionnaire.
RESULTS


In the elective cesarean section group, the average SBP was about 117.10mmHg, average DBP 70.50 mmHg, the amount of bleeding during surgery was 623.63mL, and heart rate was 88.88bpm. In the cesarean section group due to difficulty in labor progress, SBP was 113.5 mmHg, DBP 62.69 mmHg, and bleeding was 573.81mL. In addition, 9 patients in the elective group and 3 patients in the lack of progress group, did not require bolus oxytocin. In the lack of a progress group, 8 patients needed more than 5 doses of oxytocin. In addition, about 10 (12%) of all patients had no side effects, and hypotension.
CONCLUSION


Given that, the minimum effective dose of oxytocin in the elective cesarean section was 1IU, and in those in labor progress was 1-1.5IU, less oxytocin administration represents lesser side effects. It is recommended that patients who are candidates of cesarean section should be administered 1.5IU of oxytocin in the form of bolus.",2019,"In the elective cesarean section group, the average SBP was about 117.10mmHg, average DBP 70.50 mmHg, amount of bleeding during surgery was 623.63mL, and heart rate was 88.88bpm.","['patients who are candidates for cesarean section', 'Patients were divided into two groups', 'cesarean section', 'n=41) and cesarean section due to difficulty in labor (n=42 patients']","['spinal anesthesia, oxytocin', 'elective cesarean section', 'oxytocin', 'oxytocin per 1000 cc serum), and oxytocin']","['average SBP', 'side effects, and hypotension', 'systolic and diastolic blood pressure (SBP and DBP), heart rate and amount of bleeding during the operation', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",,0.0269442,"In the elective cesarean section group, the average SBP was about 117.10mmHg, average DBP 70.50 mmHg, amount of bleeding during surgery was 623.63mL, and heart rate was 88.88bpm.","[{'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Beiranvand', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Karimi', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Vahabi', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Amin-Bidokhti', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}]",Current clinical pharmacology,['10.2174/1574884714666190524100214']
632,31124422,Improving Adherence to Ticagrelor in Patients After Acute Coronary Syndrome: Results from the PROGRESS Trial.,"BACKGROUND


Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor is recommended for at least 12 months in patients after an acute coronary syndrome (ACS). However, its underuse and premature discontinuation are common in clinical practice. We aimed to investigate the impact of a dedicated follow-up strategy with clinical visits and counselling on adherence levels to ticagrelor in patients after ACS.
METHODS


PROGRESS (PROmotinG dual antiplatelet therapy adheREnce in the setting of acute coronary Syndromes) is a prospective, randomized trial enrolling 400 ACS patients treated with ticagrelor. Patients were randomized to be followed-up in a dedicated outpatient clinic (In-person follow-up group, [IN-FU], n=200), or with scheduled for phone interviews only (Telephone follow-up group [TEL-FU], n=200), to assess ticagrelor adherence and related complications. DAPT disruption was defined as an interruption of the administration of the drug due to complications or other reasons of non-adherence, and divided according to the duration into short (1-5 days), temporary (6-30 days) and permanent (≥30 days) disruption. The primary endpoint was the rate of DAPT disruption at 1-year follow-up.
RESULTS


The rate of ticagrelor disruption at 1 year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs 5.5%; p<0.0001). The IN-FU group reported a significantly lower rate of short (3.0 vs 8.5%; p=0.012) and permanent (2.0 vs 9.6%; p=0.012) disruption than TEL-FU group. The rate of major bleeding did not differ significantly between the 2 groups (p=0.450).
CONCLUSION


The PROGRESS trial showed a net reduction in DAPT disruption in patients followed-up with clinical (in-person) follow-up visits in a dedicated outpatient clinic compared with those scheduled for phone interviews only.",2020,The rate of ticagrelor disruption at 1-year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs. 5.5%; p<0.0001).,"['patients after ACS', 'patients after acute coronary syndrome', 'patients after an acute coronary syndrome (ACS', '400 ACS patients treated with']","['TEL-FU', 'aspirin and ticagrelor', 'dedicated outpatient clinic (In-person follow-up group, [IP-FU], n=200), or with scheduled for phone interviews only (Telephone follow-up group [TEL-FU', 'ticagrelor', 'Ticagrelor']","['rate of DAPT disruption', 'rate of major bleeding', 'DAPT disruption', 'ticagrelor adherence and related complications', 'rate of ticagrelor disruption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",400.0,0.0896679,The rate of ticagrelor disruption at 1-year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs. 5.5%; p<0.0001).,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Crisci', 'Affiliation': 'Department of Cardiology, Division of Interventional Cardiology, A.O.R.N. dei Colli - Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Diana', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Moscarella', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Pariggiano', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Di Maio', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Concilio', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Taglialatela', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Fimiani', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Cesaro', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}, {'ForeName': 'Plinio L', 'Initials': 'PL', 'LastName': 'Cirillo', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Calabrò', 'Affiliation': ""Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy and Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.""}]",Current vascular pharmacology,['10.2174/1570161117666190524123225']
633,31753612,Evaluation of a novel low-cost laparoscopic training model for core laparoscopic skills.,"The study involves the testing of a novel laparoscopic training model by surgeons of various levels of experience.
BACKGROUND


There has been an increasing requirement for low-cost simulation. Our aim was to evaluate the construct validity of a low-cost model for teaching core laparoscopic skills.
METHODS


The Double-Glove model was made from 2 latex gloves, one placed in the other. The inner glove was filled with water and 3 ovals were drawn on the outer glove. Participants were required to dissect the middle oval out without perforating the inner glove or leaving the line border of the middle oval. The task was assessed using a previously validated scoring system (minimum -120; maximum 80).
RESULTS


Ninety-five participants completed the task: 40 novices, 45 intermediates, and 10 experts. The model revealed statistical significance between the three groups. Experts scored higher than novices (58/80 vs 11.7/80; p < 0.0001) and intermediates (58/80 vs 29.1/80; p = 0.0004), and intermediates scored higher than novices (29.1/80 vs 11.7/80; p = 0.014). Novices took more time to complete the task compared to intermediates (10 min vs 7.87 min; p < 0.0001) and experts (10 min vs 6.98 min; p < 0.0001). No correlation between time taken and score obtained was seen (r = -0.06, r = 0.01, r = -0.2 for novice, intermediate, and expert groups).
CONCLUSION


By differentiating between groups of variable experience, the model demonstrated construct validity. It offers an inexpensive model that can be utilized in low-cost laparoscopic simulation.
TYPE OF STUDY


Study of a diagnostic test.
LEVEL OF EVIDENCE


II.",2020,"Experts scored higher than novices (58/80 vs 11.7/80; p < 0.0001) and intermediates (58/80 vs 29.1/80; p = 0.0004), and intermediates scored higher than novices (29.1/80 vs 11.7/80; p = 0.014).","['Participants were required to dissect the middle oval out without perforating the inner glove or leaving the line border of the middle oval', 'core laparoscopic skills', 'by surgeons of various levels of experience', 'Ninety-five participants completed the task: 40 novices, 45 intermediates, and 10 experts']","['novel laparoscopic training model', 'novel low-cost laparoscopic training model']",[],"[{'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",[],95.0,0.074831,"Experts scored higher than novices (58/80 vs 11.7/80; p < 0.0001) and intermediates (58/80 vs 29.1/80; p = 0.0004), and intermediates scored higher than novices (29.1/80 vs 11.7/80; p = 0.014).","[{'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Ljuhar', 'Affiliation': ""Department of Paediatric Surgery, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Surgical Simulation, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Paediatric Surgery, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.""}, {'ForeName': 'Ramesh Mark', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Paediatric Surgery, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Surgical Simulation, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia. Electronic address: ram.nataraja@monashhealth.org.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.09.020']
634,31091189,High frequency of double crossover recombination facilitates genome engineering in Pseudomonas aeruginosa PA14 and clone C strains.,"Pseudomonas aeruginosa is a key opportunistic human pathogen. An established procedure to replace a target gene is two-step allelic exchange, i.e. selection of single crossover at homologous sequences and subsequent counter selection to induce double crossover for excision of the suicide vector. In this study, we found that certain strains of P. aeruginosa display a high rate of instant double crossover upon introduction of a suicide vector containing an antibiotic resistance cassette flanked by adjacent sequences for gene replacement, making the counter selection step to achieve the second crossover superfluous. Assessment of a limited panel of target genes commonly showed negligible double crossover with a frequency <20 % in the genetic reference strain PAO1, whereas a high double crossover frequency of >70 % was observed for PA14 and clone C strains. Consequently, for certain P. aeruginosa strains replacement of an ORF by a antibiotic resistance cassette can be shortened by directly selecting for double crossover recombination.",2019,"Assessment of a limited panel of target genes commonly showed negligible double crossover with a frequency <20 % in the genetic reference strain PAO1, whereas a high double crossover frequency of >70 % was observed for PA14 and clone C strains.",[],[],[],[],[],[],,0.196147,"Assessment of a limited panel of target genes commonly showed negligible double crossover with a frequency <20 % in the genetic reference strain PAO1, whereas a high double crossover frequency of >70 % was observed for PA14 and clone C strains.","[{'ForeName': 'Changhan', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, 17177, Sweden.'}, {'ForeName': 'Shady Mansour', 'Initials': 'SM', 'LastName': 'Kamal', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, 17177, Sweden.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Römling', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, 17177, Sweden.'}]","Microbiology (Reading, England)",['10.1099/mic.0.000812']
635,31119515,"Effect of Spiritist ""Passe"" on Preoperative Anxiety of Surgical Patients: A Randomized Controlled Trial, Double-Blind.","The objective of this study was to evaluate the preoperative anxiety of hospitalized patients exposed to Spiritist ""passe,"" laying on of hand with the intention of healing (Sham) and without laying on of hand. Other variables as depression, pain, physiological parameters, muscle tension, and well-being were assessed. Patients in the Spiritist ""passe"" intervention group showed greater reductions in anxiety (p < 0.05) and muscle tension (p < 0.01) and increases in well-being (p < 0.01). More marked reductions in preoperative anxiety and muscle tension and improvement in well-being were observed in patients exposed to Spiritist ""passe"" compared to Sham or standard medical care.Trial registration: ClinicalTrials.gov Identifier NCT03356691.",2020,"Patients in the Spiritist ""passe"" intervention group showed greater reductions in anxiety (p < 0.05) and muscle tension (p < 0.01) and increases in well-being (p < 0.01).","['Surgical Patients', 'hospitalized patients exposed to Spiritist ""passe,"" laying on of hand with the intention of healing (Sham) and without laying on of hand']","['Spiritist ""Passe']","['depression, pain, physiological parameters, muscle tension, and well-being', 'preoperative anxiety and muscle tension and improvement in well-being', 'Preoperative Anxiety', 'muscle tension', 'anxiety']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0969660', 'cui_str': 'Laying-on-of-Hands'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0427195', 'cui_str': 'Muscle tension (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.109669,"Patients in the Spiritist ""passe"" intervention group showed greater reductions in anxiety (p < 0.05) and muscle tension (p < 0.01) and increases in well-being (p < 0.01).","[{'ForeName': 'Élida Mara', 'Initials': 'ÉM', 'LastName': 'Carneiro', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil. elidamc16@gmail.com.'}, {'ForeName': 'Ariana de Melo', 'Initials': 'AM', 'LastName': 'Tosta', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Izabella Barberato Silva', 'Initials': 'IBS', 'LastName': 'Antonelli', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Veridiana Mariano', 'Initials': 'VM', 'LastName': 'Soares', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Livia Figueira Avezum', 'Initials': 'LFA', 'LastName': 'Oliveira', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Rafaela Miranda Carneiro', 'Initials': 'RMC', 'LastName': 'Borges', 'Affiliation': 'University of Uberaba (UNIUBE), 50, Nenê Sabino Avenue, 1801, Uberaba, MG, 38025 050, Brazil.'}, {'ForeName': 'Adriana Paula', 'Initials': 'AP', 'LastName': 'da Silva', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Maria de Fátima', 'Initials': 'MF', 'LastName': 'Borges', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}]",Journal of religion and health,['10.1007/s10943-019-00841-7']
636,31107412,Testing a positive-affect induction to reduce verbally induced nocebo hyperalgesia in an experimental pain paradigm.,"There is an ethical obligation to notify individuals about potential pain associated with diagnoses, treatments, and procedures; however, supplying this information risks inducing nocebo hyperalgesia. Currently, there are few empirically derived strategies for reducing nocebo hyperalgesia. Because nocebo effects are linked to negative affectivity, we tested the hypothesis that a positive-affect induction can disrupt nocebo hyperalgesia from verbal suggestion. Healthy volunteers (N = 147) were randomly assigned to conditions in a 2 (affect induction: positive vs neutral) by 2 (verbal suggestion: no suggestion vs suggestion of pain increase) between-subjects design. Participants were induced to experience positive or neutral affect by watching movie clips for 15 minutes. Next, participants had an inert cream applied to their nondominant hand, and suggestion was manipulated by telling only half the participants the cream could increase the pain of the upcoming cold pressor test. Subsequently, all participants underwent the cold pressor test (8 ± 0.04°C), wherein they submerged the nondominant hand and rated pain intensity on numerical rating scales every 20 seconds up to 2 minutes. In the neutral-affect conditions, there was evidence for the nocebo hyperalgesia effect: participants given the suggestion of pain displayed greater pain than participants not receiving this suggestion, P's < 0.05. Demonstrating a blockage effect, nocebo hyperalgesia did not occur in the positive-affect conditions, P's > 0.5. This is the first study to show that positive affect may disrupt nocebo hyperalgesia thereby pointing to a novel strategy for decreasing nocebo effects without compromising the communication of medical information to patients in clinical settings.",2019,"participants given the suggestion of pain displayed greater pain than participants not receiving this suggestion, ps<.05.",['Healthy volunteers (N =147'],"['cold pressor test (8C ±.04C', 'Induction: Positive vs. Neutral) by 2 (Verbal Suggestion']","['pain of the upcoming cold pressor test', 'pain', 'nocebo hyperalgesia effect']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",147.0,0.0466488,"participants given the suggestion of pain displayed greater pain than participants not receiving this suggestion, ps<.05.","[{'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, United States.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Close', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, United States.'}, {'ForeName': 'Fawn C', 'Initials': 'FC', 'LastName': 'Caplandies', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, United States.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, United States.'}, {'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Murray', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, United States.'}, {'ForeName': 'Yopina', 'Initials': 'Y', 'LastName': 'Pertiwi', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, United States.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Handley', 'Affiliation': 'Department of Psychology, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University Hospital, Aarhus, Denmark.'}]",Pain,['10.1097/j.pain.0000000000001618']
637,31075423,Implementing international osteoarthritis guidelines in primary care: uptake and fidelity among health professionals and patients.,"OBJECTIVE


This paper evaluates the implementation fidelity of a strategy and intervention used to implement osteoarthritis (OA) treatment recommendations in primary care. We also evaluate uptake of core treatment (patient information, exercise and referral to weight management) among OA patients.
DESIGN


A stepped-wedge cluster-randomised controlled study (RCT) in primary care. The study involved general practitioners (GPs), physiotherapists (PTs) and patients with hip and/or knee OA in six Norwegian municipalities (clusters). Workshops for general practitioners (GPs) and PTs represented the main implementation activity. Uptake of core treatment (patient education, exercise and weight management) was evaluated using self-reported data from the patient intervention and control group, analysed with logistic regression models. Fidelity was evaluated using six components representing adherence to the content and dose instructions in the implementation strategy and assessed against a-priori criteria for high adherence.
RESULTS


Data were collected from 40 GPs, 37 PTs and 393 OA patients. The patient-reported data showed statistically significant higher uptake for exercise, patient education and referral to support for weight reduction, among the intervention group compared to the control group (P < 0.05). Evaluation of fidelity showed high adherence to GP and PT workshop attendance and physiotherapy use, partly adherence to PT knowledge after workshops, and low adherence to exercise attendance, dose and progression instructions.
CONCLUSIONS


The implementation strategy and intervention successfully improved OA patients' access to physiotherapy and uptake of recommended core treatment. However, the strategy was less effective in providing exercise programs with sufficient dose and progression and in supporting patients' adherence to the exercise program.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02333656.",2019,"The patient-reported data showed statistically significant higher uptake for exercise, patient education and referral to support for weight reduction, among the intervention group compared to the control group (P < 0.05).","['Data were collected from 40\xa0GPs, 37\xa0PTs and 393 OA patients', 'OA patients', 'general practitioners (GPs), physiotherapists (PTs) and patients with hip and/or knee OA in six Norwegian municipalities (clusters']",[],"['uptake for exercise, patient education and referral to support for weight reduction']","[{'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0600182'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0649022,"The patient-reported data showed statistically significant higher uptake for exercise, patient education and referral to support for weight reduction, among the intervention group compared to the control group (P < 0.05).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moseng', 'Affiliation': 'National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, P.O. Box 23 Vinderen, N-0319, Oslo, Norway. Electronic address: tuva.moseng@medisin.uio.no.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dagfinrud', 'Affiliation': 'National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, P.O. Box 23 Vinderen, N-0319, Oslo, Norway. Electronic address: h.s.dagfinrud@medisin.uio.no.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Østerås', 'Affiliation': 'National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, P.O. Box 23 Vinderen, N-0319, Oslo, Norway. Electronic address: nina.osteras@medisin.uio.no.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.03.010']
638,31073124,Follow-up interviews from The Salford Lung Study (COPD) and analyses per treatment and exacerbations.,"The Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) was a 12-month, Phase III, open-label, randomised study comparing the effectiveness and safety of initiating once-daily fluticasone furoate 100 µg/vilanterol 25 µg (FF/VI) with continuing usual care (UC). Follow-up interviews were conducted among a subset of 400 patients who completed SLS COPD to further understand patients' experiences with treatment outcomes and the impact of COPD, and potential risk factors associated with higher rates of exacerbations during SLS COPD. Another objective was to explore how such patient-centred outcomes differed by randomised treatment. Patients' perceived control over COPD and effects on quality of life (QoL) were similar between treatment groups at the time of the follow-up interview, but more patients in the FF/VI group compared with UC reported perceived improvements in COPD control and QoL during the study. Of patients who experienced ≥2 exacerbations during SLS COPD, a greater percentage were women, were unemployed or homemakers, or were on long-term sick leave. Having ≥2 exacerbations also appeared to be associated with smoking, seeing a hospital specialist, a feeling of having no/little control over COPD, perceived worsening of feelings of control and reduced overall QoL since the start of the study, being aware of impending exacerbation occurrence and a more severe last exacerbation. Initiation of FF/VI was associated with a greater perceived improvement in patients' control of their COPD and QoL throughout SLS COPD than continuation of UC. Suggestions that smoking status and feelings of control are potentially related to exacerbation require further investigation.",2019,Initiation of FF/VI was associated with a greater perceived improvement in patients' control of their COPD and QoL throughout SLS COPD than continuation of UC.,"['Of patients who experienced ≥2 exacerbations during SLS COPD, a greater percentage were women, were unemployed or homemakers, or were on long-term sick leave', 'chronic obstructive pulmonary disease (SLS COPD', '400 patients who completed']","['fluticasone furoate 100\u2009µg/vilanterol 25\u2009µg (FF/VI) with continuing usual care (UC', 'SLS COPD']","['COPD control and QoL', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0555052', 'cui_str': 'Homemaker (person)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}]",,0.0466253,Initiation of FF/VI was associated with a greater perceived improvement in patients' control of their COPD and QoL throughout SLS COPD than continuation of UC.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Whalley', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Svedsater', 'Affiliation': 'Value Evidence & Outcomes, GlaxoSmithKline plc., Brentford, Middlesex, UK. henrik.x.svedsater@gsk.com.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Doward', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Crawford', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leather', 'Affiliation': 'Global Respiratory Franchise, GlaxoSmithKline plc., Uxbridge, Middlesex, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lay-Flurrie', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline plc., Uxbridge, Middlesex, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bosanquet', 'Affiliation': 'Imperial College London, London, UK.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-019-0123-0']
639,31742685,Modular cognitive-behavioral therapy for affective symptoms in young individuals at ultra-high risk of first episode of psychosis: Randomized controlled trial.,"OBJECTIVES


Individuals at ultra-high risk of psychosis often present concurrent affective symptoms (depression/anxiety). This study investigated whether modular cognitive-behavioral therapy (CBT) targeting both ultra-high risk and affective symptoms (a) reduced/delayed risk of a first psychotic episode at posttreatment and 14-month follow-up compared with a supportive intervention, (b) was more effective than control condition in producing remission on depression/anxiety.
METHODS


Fifty-eight ultrahigh risk individuals were randomly assigned to CBT or control condition. CBT consisted of 30 sessions, including CBT for psychotic experiences and depression/anxiety.
RESULTS


In the CBT group, the cumulative number of participants who developed a first psychotic episode (n = 3, 10.34%) at follow-up was lower than in the control group (n = 8, 27.60%; logrank χ 2   (1)   = 3.68, p = .05). In the CBT group, a higher number of participants achieved remission than in control condition on affective symptoms at posttreatment/follow-up.
CONCLUSION


CBT can prevent psychosis risk and produce better outcomes on depression/anxiety than supportive intervention.",2020,"In the CBT group, a higher number of participants achieved remission than in control condition on affective symptoms at posttreatment/follow-up.
","['young individuals at ultra-high risk of first episode of psychosis', 'Individuals at ultra-high risk of psychosis often present concurrent affective symptoms (depression/anxiety', 'Fifty-eight', 'ultrahigh risk individuals']","['Modular cognitive-behavioral therapy', 'CBT', 'modular cognitive-behavioral therapy (CBT']","['affective symptoms', 'delayed risk of a first psychotic episode', 'cumulative number of participants who developed a first psychotic episode']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0338614'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0437043,"In the CBT group, a higher number of participants achieved remission than in control condition on affective symptoms at posttreatment/follow-up.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pozza', 'Affiliation': 'Department of Health Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Dèttore', 'Affiliation': 'Department of Health Sciences, University of Florence, Florence, Italy.'}]",Journal of clinical psychology,['10.1002/jclp.22901']
640,30994460,Interruptive Versus Noninterruptive Clinical Decision Support: Usability Study.,"BACKGROUND


Clinical decision support (CDS) has been shown to improve compliance with evidence-based care, but its impact is often diminished because of issues such as poor usability, insufficient integration into workflow, and alert fatigue. Noninterruptive CDS may be less subject to alert fatigue, but there has been little assessment of its usability.
OBJECTIVE


This study aimed to study the usability of interruptive and noninterruptive versions of a CDS.
METHODS


We conducted a usability study of a CDS tool that recommended prescribing an angiotensin-converting enzyme inhibitor for inpatients with heart failure. We developed 2 versions of the CDS: an interruptive alert triggered at order entry and a noninterruptive alert listed in the sidebar of the electronic health record screen. Inpatient providers were recruited and randomly assigned to use the interruptive alert followed by the noninterruptive alert or vice versa in a laboratory setting. We asked providers to ""think aloud"" while using the CDS and then conducted a brief semistructured interview about usability. We used a constant comparative analysis informed by the CDS Five Rights framework to analyze usability testing.
RESULTS


A total of 12 providers participated in usability testing. Providers noted that the interruptive alert was readily noticed but generally impeded workflow. The noninterruptive alert was felt to be less annoying but had lower visibility, which might reduce engagement. Provider role seemed to influence preferences; for instance, some providers who had more global responsibility for patients seemed to prefer the noninterruptive alert, whereas more task-oriented providers generally preferred the interruptive alert.
CONCLUSIONS


Providers expressed trade-offs between impeding workflow and improving visibility with interruptive and noninterruptive versions of a CDS. In addition, 2 potential approaches to effective CDS may include targeting alerts by provider role or supplementing a noninterruptive alert with an occasional, well-timed interruptive alert.",2019,We developed 2 versions of the CDS: an interruptive alert triggered at order entry and a noninterruptive alert listed in the sidebar of the electronic health record screen.,"['inpatients with heart failure', 'Inpatient providers', '12 providers participated in usability testing']","['angiotensin-converting enzyme inhibitor', 'interruptive alert followed by the noninterruptive alert or vice versa in a laboratory setting']",[],"[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],12.0,0.0487437,We developed 2 versions of the CDS: an interruptive alert triggered at order entry and a noninterruptive alert listed in the sidebar of the electronic health record screen.,"[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Blecker', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, United States.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Pandya', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York, NY, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stork', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, United States.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, United States.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Kuperman', 'Affiliation': 'Memorial Sloane Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, United States.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Austrian', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York, NY, United States.'}]",JMIR human factors,['10.2196/12469']
641,31429944,Influence of pain anticipation on brain activity and pain perception in Gulf War Veterans with chronic musculoskeletal pain.,"Anticipation of a painful experience can influence brain activity and increase sensitivity to experimental somatosensory stimuli in healthy adults, but this response is poorly understood among individuals with chronic musculoskeletal pain (CMP). Studies of brain and perceptual responses to somatosensory stimuli are used to make inferences about central nervous system dysfunction as a potential mechanism of symptoms. As such, we sought to (a) determine the influence of pain anticipation on pain-relevant brain regions and pain perception, and (b) characterize potential differences in these responses between Gulf War Veterans with CMP and matched healthy control (CO) Veterans. CMP (N = 30) and CO Veterans (N = 31) were randomized to conditions designed to generate expectations that either painful (pain) or nonpainful (no pain) stimuli would be administered. Brain responses to five nonpainful thermal stimuli were measured during fMRI, and each stimulus was rated for pain intensity and unpleasantness. In the pain condition, an incremental linear decrease in activity across stimuli was observed in the posterior cingulate cortex, cingulate cortex, and middle temporal gyrus. Further, in the pain condition, differential responses were observed between CMP and CO Veterans in the middle temporal gyrus. These findings indicate that brain responses to nonpainful thermal stimuli in Veterans with CMP are sensitive to pain anticipation, and we recommend accounting for the influence of pain anticipation in future investigations of central nervous system dysfunction in CMP.",2019,"In the pain condition, an incremental linear decrease in activity across stimuli was observed in the posterior cingulate cortex, cingulate cortex, and middle temporal gyrus.","['Veterans with CMP', 'Gulf War Veterans with CMP and matched healthy control (CO) Veterans', 'N\xa0=\xa030) and CO Veterans (N\xa0=\xa031', 'healthy adults', 'individuals with chronic musculoskeletal pain (CMP', 'Gulf War Veterans with chronic musculoskeletal pain']","['pain anticipation', 'CMP', 'painful (pain) or nonpainful (no pain) stimuli']","['pain intensity and unpleasantness', 'brain activity and pain perception']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0010729', 'cui_str': 'Cytidylic Acid'}, {'cui': 'C1449761', 'cui_str': 'Gulf War'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010729', 'cui_str': 'Cytidylic Acid'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}]",,0.0220629,"In the pain condition, an incremental linear decrease in activity across stimuli was observed in the posterior cingulate cortex, cingulate cortex, and middle temporal gyrus.","[{'ForeName': 'Jacob B', 'Initials': 'JB', 'LastName': 'Lindheimer', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Stegner', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Ellingson-Sayen', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, Iowa.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Van Riper', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Dougherty', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Falvo', 'Affiliation': 'Department of Veterans Affairs, NJ Health Care System, War Related Illness and Injury Study Center, East Orange, New Jersey.'}, {'ForeName': 'Dane B', 'Initials': 'DB', 'LastName': 'Cook', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}]",Psychophysiology,['10.1111/psyp.13452']
642,31062295,At-Home Cortical Stimulation for Neuropathic Pain: a Feasibility Study with Initial Clinical Results.,"The clinical use of noninvasive cortical stimulation procedures is hampered by the limited duration of the analgesic effects and the need to perform stimulation in hospital settings. Here, we tested the feasibility and pilot efficacy of an internet-based system for at-home, long-duration, medically controlled transcranial motor cortex stimulation (H-tDCS), via a double-blinded, sham-controlled trial in patients with neuropathic pain refractory to standard-of-care drug therapy. Each patient was first trained at hospital, received a stimulation kit, allotted a password-protected Web space, and completed daily tDCS sessions during 5 weeks, via a Bluetooth connection between stimulator and a minilaptop. Each session was validated and internet-controlled by hospital personnel. Daily pain ratings were obtained during 11 consecutive weeks, and afterwards via iterative visits/phone contacts. Twenty full procedures were completed in 12 consecutive patients (500 daily tDCS sessions, including 20% sham). No serious adverse effects were recorded. Superficial burning at electrode position occurred in 2 patients, and nausea/headache in two others, all of whom wished to pursue stimulation. Six out of the 12 patients achieved satisfactory relief on a scale combining pain scores, drug intake, and quality of life. Daily pain reports correlated with such combined assessment, and differentiated responders from nonresponders without overlap. Clinical improvement in responders could last up to 6 months. Five patients asked to repeat the whole procedure when pain resumed again, with comparable results. At-home, long-duration tDCS proved safe and technically feasible, and provided long-lasting relief in 50% of a small sample of patients with drug-resistant neuropathic pain.",2019,"Six out of the 12 patients achieved satisfactory relief on a scale combining pain scores, drug intake, and quality of life.","['Neuropathic Pain', 'patients with neuropathic pain refractory to standard-of-care drug therapy']","['noninvasive cortical stimulation procedures', 'internet-based system for at-home, long-duration, medically controlled transcranial motor cortex stimulation (H-tDCS']","['serious adverse effects', 'satisfactory relief on a scale combining pain scores, drug intake, and quality of life', 'nausea/headache', 'Superficial burning at electrode position', 'Daily pain', 'Daily pain ratings']","[{'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0034380'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",5.0,0.198689,"Six out of the 12 patients achieved satisfactory relief on a scale combining pain scores, drug intake, and quality of life.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Larrea', 'Affiliation': 'Central Integration of Pain (NeuroPain) Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard Lyon 1, F-69677, Bron, France. Larrea@univ-lyon1.fr.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Perchet', 'Affiliation': 'Central Integration of Pain (NeuroPain) Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard Lyon 1, F-69677, Bron, France.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Central Integration of Pain (NeuroPain) Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard Lyon 1, F-69677, Bron, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'André-Obadia', 'Affiliation': 'Central Integration of Pain (NeuroPain) Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard Lyon 1, F-69677, Bron, France.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-019-00734-3']
643,31076215,Long-Term Outcomes of the Benefit-Finding Group Intervention for Alzheimer Family Caregivers: A Cluster-Randomized Double-Blind Controlled Trial.,"OBJECTIVES


To examine the effects of the group benefit-finding therapeutic intervention (BFT) for Alzheimer family caregivers up to 10-month follow-up.
METHODS


This was a cluster-randomized double-blind controlled trial in social centers and clinics. Participants included 129 caregivers. Inclusion criteria were 1) primary caregiver aged 18 years and older and without cognitive impairment, 2) providing 14 or more care hours per week to a relative with mild-to-moderate Alzheimer disease, and 3) scoring 3 or more on the Hamilton Depression Rating Scale. Exclusion criterion was care-recipient having parkinsonism or other forms of dementia. BFT (using cognitive reappraisal to find positive meanings) was evaluated against two forms of psychoeducation as controls-standard and simplified (lectures only) psychoeducation. All interventions had eight weekly sessions of 2 hours each. Primary outcome was depressive symptoms, whereas secondary outcomes were global burden, role overload, and psychological well-being. Measures were collected at baseline, postintervention, and 4- and 10-month follow-up.
RESULTS


Mixed-effects regression showed that BFT's effect on depressive symptoms conformed to a curvilinear pattern, in which the strong initial effect leveled out after postintervention and was maintained up to 10-month follow-up; this was true when compared against either control group. The effect on global burden was less impressive but moderate effect sizes were found at the two follow-ups. For psychological well-being, there was an increase in the BFT group at 4-month follow-up and a return to baseline afterward. No effect on role overload was found.
CONCLUSION


Benefit-finding reduces depressive symptoms as well as global burden in the long-term and increases psychological well-being in the medium-term.",2019,"For psychological well-being, there was an increase in the BFT group at 4-month follow-up and a return to baseline afterward.","['Inclusion criteria were 1) primary caregiver aged 18 years and older and without cognitive impairment, 2) providing 14 or more care hours per week to a relative with mild-to-moderate Alzheimer disease, and 3) scoring 3 or more on the', 'Alzheimer family caregivers up to 10-month follow-up', 'Alzheimer Family Caregivers', 'Participants included 129 caregivers', 'social centers and clinics']","['BFT', 'group benefit-finding therapeutic intervention (BFT']","['Hamilton Depression Rating Scale', 'global burden, role overload, and psychological well-being', 'depressive symptoms']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",129.0,0.4811,"For psychological well-being, there was an increase in the BFT group at 4-month follow-up and a return to baseline afterward.","[{'ForeName': 'Sheung-Tak', 'Initials': 'ST', 'LastName': 'Cheng', 'Affiliation': 'Department of Health and Physical Education (S-TC), The Education University of Hong Kong, Hong Kong; Department of Clinical Psychology (S-TC), Norwich Medical School, University of East Anglia, Norwich, United Kingdom. Electronic address: takcheng@eduhk.hk.'}, {'ForeName': 'Wai Chi', 'Initials': 'WC', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry (WCC), University of Hong Kong, Hong Kong.'}, {'ForeName': 'Linda C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry (LCWL), Chinese University of Hong Kong, Hong Kong.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.03.013']
644,31736382,Influence of Cooking Workshops on Cooking Skills and Knowledge among Children Attending Summer Day Camps.,"This study aimed to measure the influence of the  Chefs in Action  program (3 cooking workshops) on cooking skills, nutrition knowledge, and attitudes towards healthy eating in children attending summer day camps and compare it with a single cooking workshop. Groups of children (8-12 years) were randomly assigned to the intervention group (n = 25) or to 1 of 3 comparison groups performing a single workshop (group 1, n = 16; group 2, n = 36; group 3, n = 24). Two dietitians evaluated cooking skills during the workshops. Nutrition knowledge and attitudes towards healthy eating were assessed before and after the intervention. No improvement in cooking skills was observed in the intervention group ( P  = 0.25). The intervention group's cooking skills score was significantly higher than comparison group 1 ( P  < 0.001). Nutrition knowledge was significantly improved in the intervention group and the comparison group 3 ( P  < 0.0001) but no effect on attitudes towards healthy eating was observed ( P group × time  = 0.36). In conclusion, the  Chefs in Action  program positively impacted nutrition knowledge in children. The results also suggest that the type of recipe may influence nutrition knowledge and cooking skills. Further studies are needed to better assess the degree of difficulty required in cooking workshop recipes to improve cooking skills in children.",2020,The intervention group's cooking skills score was significantly higher than comparison group 1 ( P  < 0.001).,"['Groups of children (8-12 years', 'children', 'Children Attending Summer Day Camps', 'children attending summer day camps']","['Cooking Workshops', 'Action  program (3 cooking workshops', 'single workshop']","['cooking skills', 'cooking skills score', 'cooking skills, nutrition knowledge, and attitudes towards healthy eating', 'attitudes towards healthy eating', 'Cooking Skills and Knowledge', 'Nutrition knowledge and attitudes towards healthy eating', 'Nutrition knowledge', 'nutrition knowledge and cooking skills']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",,0.0203879,The intervention group's cooking skills score was significantly higher than comparison group 1 ( P  < 0.001).,"[{'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Jacob', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Motard-Bélanger', 'Affiliation': 'Dairy Farmers of Canada, Montreal, QC.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}, {'ForeName': 'Melissa Anne', 'Initials': 'MA', 'LastName': 'Fernandez', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Gayraud', 'Affiliation': 'Dairy Farmers of Canada, Montreal, QC.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Drapeau', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}]",Canadian journal of dietetic practice and research : a publication of Dietitians of Canada = Revue canadienne de la pratique et de la recherche en dietetique : une publication des Dietetistes du Canada,['10.3148/cjdpr-2019-030']
645,31067329,Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study.,"STUDY QUESTION


Does the GnRH antagonist, ASP1707, reduce endometriosis-associated pelvic pain?
SUMMARY ANSWER


ASP1707 significantly reduced endometriosis-associated pelvic pain in a dose-related manner.
WHAT IS KNOWN ALREADY


GnRH agonists are an effective therapeutic option for endometriosis that is refractory to non-steroidal anti-inflammatory drugs, oral contraceptives, and progestins. However, GnRH agonists cause complete suppression of estradiol (E2), resulting in hypoestrogenic side-effects such as bone loss that may increase the future risk of osteoporotic fractures.
STUDY DESIGN, SIZE, DURATION


This was a Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study conducted in 540 women from 04 December 2012 to 30 July 2015 in Europe and Japan. A sample size of 504 (84 subjects per group) was calculated to provide ≥80% power to detect a dose-related treatment effect among placebo and ASP1707 doses in change from baseline in pelvic pain, assuming different dose-response curves after 12 weeks of treatment.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Of 912 women with endometriosis-associated pelvic pain screened, 540 were enrolled, and 532 received ≥1 dose of study drug (placebo, n = 88; ASP1707 3 mg, n = 86; ASP1707 5 mg, n = 91; ASP1707 10 mg, n = 90; ASP1707 15 mg, n = 88; leuprorelin, n = 89) for 24 weeks.
MAIN RESULTS AND THE ROLE OF CHANCE


After 12 weeks of treatment with ASP1707, the mean (95% CI) changes in numeric rating score (NRS) for overall pelvic pain (OPP) were -1.56 (-1.91, -1.21), -1.63 (-1.99, -1.27), -1.93 (-2.27, -1.60), -2.29 (-2.64, -1.94), and -2.13 (-2.47, -1.79) for placebo, ASP1707 3 mg, ASP1707 5 mg, ASP1707 10 mg, and ASP1707 15 mg, respectively. Mean (95% CI) changes in NRS for dysmenorrhea were -1.50 (-2.00, -1.00), -2.72 (-3.22, -2.21), -2.85 (-3.33, -2.38), -3.97 (-4.46, -3.48), and -4.18 (-4.66, -3.70), respectively. Mean (95% CI) changes in NRS for non-menstrual pelvic pain (NMPP) were -1.53 (-1.88, -1.19), -1.51 (-1.87, -1.16), -1.80 (-2.14, -1.47), -2.03 (-2.37, -1.68), and -1.86 (-2.20, -1.52), respectively. Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks. Serum estradiol and bone mineral density decreased dose dependently with ASP1707 through 24 weeks, however, to a lesser extent than with leuprorelin.
LIMITATIONS, REASON FOR CAUTION


This study was not powered for pairwise comparison of each ASP1707 group versus placebo.
WIDER IMPLICATIONS OF THE FINDINGS


All doses of ASP1707 reduced serum E2 levels to within the target range and to a lesser extent than leuprorelin. ASP1707 is a potential alternative treatment to leuprorelin for endometriosis-associated pelvic pain with lower impact on bone health.
STUDY FUNDING/COMPETING INTEREST(S)


This study was funded by Astellas Pharma Inc. T.D'.H is Vice President and Head of Global Medical Affairs Fertility at Merck, Darmstadt, Germany since October 1, 2015. At the time that the TERRA study was conducted, he served as Principal Investigator in his role as Coordinator of the Leuven University Fertility Center. Since October 2015, T.D'.H has left Leuven University Hospital Gasthuisberg, but continues to serve as Professor in Reproductive Medicine and Biology at KU Leuven (University of Leuven) Belgium and at the Dept of Obstetrics, Gynecology and Reproduction at Yale University, New Haven, USA. T. Fukaya and Y. Osuga report personal consulting fees from Astellas Pharma Inc. during the conduct of the study and outside the submitted work. G.M. Holtkamp, and L. Skillern are employed by Astellas Pharma Europe B.V.; K. Miyazaki is employed by Astellas Pharma Inc.; B. López, was a biostatistician for Astellas Pharma Europe B.V. during conduct of the study; R. Besuyen was a contract Associate Director of Medical Science for Astellas during conduct of the study.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov, www.clinicaltrials.gov, NCT01767090. EudraCT number 2012-002791-14.
TRIAL REGISTRATION DATE


18 December 2012.
DATE OF FIRST SUBJECT’S ENROLLMENT


One subject signed informed consent on 04 December 2012; the first subject was randomized on 16 April 2013.",2019,"Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks.","['18 December 2012', '540 women from 04 December 2012 to 30 July 2015 in Europe and Japan', 'endometriosis-associated pelvic pain', 'Of 912 women with endometriosis-associated pelvic pain screened, 540 were enrolled, and 532 received ≥1 dose of study drug (placebo, n = 88']","['GnRH agonists', 'placebo', 'placebo, ASP1707', 'ASP1707', 'placebo and ASP1707']","['NRS for dysmenorrhea', 'numeric rating score (NRS) for overall pelvic pain (OPP', 'dysmenorrhea', 'serum E2 levels', 'NRS for non-menstrual pelvic pain (NMPP', 'Efficacy and safety', 'Serum estradiol and bone mineral density', 'endometriosis-associated pelvic pain', 'NMPP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0911329', 'cui_str': 'OPP'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]",540.0,0.225805,"Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""D'Hooghe"", 'Affiliation': 'Research Group Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Belgium.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Tohoku Medical and Pharmaceutical University, 4-4-1 Komatsushima, Aobaku, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'The University of Tokyo, Graduate School of Medicine, 7-3-1, Hongo, Bunkyo, Tokyo, Japan.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'López', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Gertjan M', 'Initials': 'GM', 'LastName': 'Holtkamp', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Miyazaki', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Skillern', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez028']
646,31550872,Comparison of propofol-ketamine versuspropofol-remifentanil in children anaesthetized for gastroscopy.,"BACKGROUND


The search for ideal anaesthesia is still an open research issue. The aim of the study was to evaluate and compare two methods of general anaesthesia with preserved own breath - propofol with ketamine and propofol with remifentanil - in children anaesthetized for gastroscopy.
METHODS


The study included 90 children enrolled for elective endoscopy of the upper gastrointestinal tract under general anaesthesia. The patients were randomized to one of two groups: Group K consisted of children anesthetized with propofol and ketamine, Group R included children anesthetized with propofol and remifentanil. Parameters monitored during anaesthesia were induction time, respiratory and circulatory parameters, adverse events, waking time and the child's condition after regaining consciousness.
RESULTS


The groups differed significantly in time of induction of anaesthesia (Group K 3 ± 1 min vs. Group R 4 ± 2.5 min; P < 0.001), waking time (Group R 4 ± 4.5 min vs. Group K 6 ± 5 min; P < 0.01), condition of the child after regaining consciousness (Group R 90.9% calm, Group of K 54% confused; P < 0.001) and evaluation of test conditions in the opinion of the gastroenterologist (in favour of Group K; P < 0.05).
CONCLUSIONS


Both methods of anaesthesia presented in the paper are safe and can be used in children to perform endoscopy. Combining propofol with ketamine allows fast induction of anaesthesia and creates very good conditions for the examination. Combining propofol with remifentanil allows fast and full return of consciousness after anaesthesia.",2019,"The groups differed significantly in time of induction of anaesthesia (Group K 3 ± 1 min vs. Group R 4 ± 2.5 min; P < 0.001), waking time (Group R 4 ± 4.5 min vs. Group K 6 ± 5 min; P < 0.01), condition of the child after regaining consciousness (Group R 90.9% calm, Group of K 54% confused; P < 0.001) and evaluation of test conditions in the opinion of the gastroenterologist (in favour of Group K; P < 0.05).
","['children anaesthetized for gastroscopy', '90 children enrolled for elective endoscopy of the upper gastrointestinal tract under general anaesthesia']","['propofol with remifentanil', 'general anaesthesia with preserved own breath - propofol with ketamine and propofol with remifentanil ', 'propofol and remifentanil', 'propofol with ketamine', 'propofol-ketamine versuspropofol-remifentanil', 'children anesthetized with propofol and ketamine']","['condition of the child after regaining consciousness', ""induction time, respiratory and circulatory parameters, adverse events, waking time and the child's condition after regaining consciousness"", 'waking time', 'time of induction of anaesthesia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C3203348', 'cui_str': 'Upper Gastrointestinal Tract'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C2223560', 'cui_str': 'Time of induction of anesthesia (observable entity)'}]",90.0,0.0160551,"The groups differed significantly in time of induction of anaesthesia (Group K 3 ± 1 min vs. Group R 4 ± 2.5 min; P < 0.001), waking time (Group R 4 ± 4.5 min vs. Group K 6 ± 5 min; P < 0.01), condition of the child after regaining consciousness (Group R 90.9% calm, Group of K 54% confused; P < 0.001) and evaluation of test conditions in the opinion of the gastroenterologist (in favour of Group K; P < 0.05).
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Damps', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Upper Silesian Child Health Centre, Katowice, Poland.'}, {'ForeName': 'Ludwik', 'Initials': 'L', 'LastName': 'Stołtny', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Upper Silesian Child Health Centre, Katowice, Poland.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Siemek-Mitela', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Upper Silesian Child Health Centre, Katowice, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Lekstan', 'Affiliation': 'Department of Surgery, Vascular Surgery and Transplantation, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Krzych', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kucewicz-Czech', 'Affiliation': 'Department of Cardiac Anaesthesia and Intensive Therapy, Medical University of Silesia, Katowice, Poland.'}]",Anaesthesiology intensive therapy,['10.5114/ait.2019.88185']
647,31027929,Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against all respiratory tract infections in children under two years of age.,"BACKGROUND


Pneumococcal conjugate vaccines reduce the incidence of invasive pneumococcal diseases, pneumonia, acute otitis media (AOM), and antimicrobial prescriptions in children. We investigated the effectiveness of at least one dose of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GSK) against respiratory tract infections (RTIs) in children under two years of age.
METHODS


424 children enrolled in a cluster-randomized, double-blind Finnish Invasive Pneumococcal disease (FinIP) vaccine trial during the years 2009-2010 were actively followed in a prospective cohort study (STEPS study) for RTIs from birth to two years of age. Children received the PHiD-CV10 vaccine, or a control vaccine (hepatitis A or B vaccine) according to an age-specific schedule. Data on RTIs were collected by symptom diaries, clinic visits, an electronic registry on hospitalizations, and by nasal swab samples analyzed for respiratory viruses. We estimated the vaccine effectiveness against all RTI episodes and RTI episodes with or without AOM by comparing the corresponding incidence rates between PHiD-CV10 vaccinated and control children, adjusted for presence of siblings and cluster as a random effect.
RESULTS


A total of 3193 RTI episodes were documented after the first vaccination in 368 children with all data available. The majority of the illnesses were upper RTIs caused by rhinovirus. The PHiD-CV10-vaccinated children had lower mean annual rates of all RTI episodes (6.4; 95% confidence interval [CI], 6.0-6.8) and RTI episodes with AOM (1.0; 95% CI, 0.9-1.2) as compared to the control children (7.4; 95% CI, 6.8-8.0 and 1.3; 95% CI, 1.1-1.6, respectively). The vaccine effectiveness was 12% (95% CI, 2-22%) against all RTIs, 23% (95% CI, 0-40%) against RTIs with AOM, and 10% (95% CI, 0-19%) against RTIs without AOM.
CONCLUSIONS


Vaccination with PHiD-CV10 resulted in lower rates of RTIs in children under two years of age compared to children vaccinated with control vaccine.",2019,"The vaccine effectiveness was 12% (95% CI, 2-22%) against all RTIs, 23% (95% CI, 0-40%) against RTIs with AOM, and 10% (95% CI, 0-19%) against RTIs without AOM.
","['children under two years of age', '424 children enrolled in a cluster-randomized, double-blind Finnish Invasive Pneumococcal disease (FinIP) vaccine trial during the years 2009-2010 were actively followed in a prospective cohort study (STEPS study) for RTIs from birth to two years of age', 'children', '368 children with all data available']","['PHiD-CV10', 'pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GSK', 'ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10', 'PHiD-CV10 vaccine, or a control vaccine (hepatitis A or B vaccine']","['mean annual rates of all RTI episodes', 'rates of RTIs', 'vaccine effectiveness', 'vaccine effectiveness against all RTI episodes and RTI episodes', 'RTI episodes with AOM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1320214', 'cui_str': 'Invasive Streptococcus pneumoniae disease'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0450819', 'cui_str': 'CV10 (body structure)'}, {'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019159', 'cui_str': 'Hepatitis, Infectious'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",424.0,0.304624,"The vaccine effectiveness was 12% (95% CI, 2-22%) against all RTIs, 23% (95% CI, 0-40%) against RTIs with AOM, and 10% (95% CI, 0-19%) against RTIs without AOM.
","[{'ForeName': 'Sinikka', 'Initials': 'S', 'LastName': 'Karppinen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland. Electronic address: simahe@utu.fi.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Toivonen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Schuez-Havupalo', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Teros-Jaakkola', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Waris', 'Affiliation': 'Department of Virology and Clinical Virology, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Auranen', 'Affiliation': 'Department of Mathematics and Statistics, University of Turku, Turku, Finland; Department of Clinical Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Arto A', 'Initials': 'AA', 'LastName': 'Palmu', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Tampere, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Peltola', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}]",Vaccine,['10.1016/j.vaccine.2019.04.026']
648,31735684,Effectiveness of Incentive Spirometry on Inspiratory Muscle Strength After Coronary Artery Bypass Graft Surgery.,"BACKGROUND


Although the use of incentive spirometry with a deep breathing exercise (DBE) is widely used in clinical practice in patients who have undergone coronary artery bypass graft (CABG) surgery, the effect of this combination therapy has not been conclusively elucidated. The aim of this study was to investigate the effect of postoperative combined incentive spirometry and DBE versus DBE alone on inspiratory muscle strength following CABG.
METHOD


This randomised clinical trial was conducted in patients scheduled to undergo CABG surgery at Siriraj Hospital, Bangkok Thailand. The study group received incentive spirometry and DBE, and the control group received DBE only. Maximal inspiratory pressure (MIP) before surgery and at day 4 after surgery was assessed by a respiratory pressure meter. Secondary outcomes, including postoperative pulmonary complication and duration of postoperative hospitalisation, were obtained from the medical records.
RESULTS


Ninety (90) patients were included, with 47 and 43 patients assigned to the study and control groups, respectively. In both groups, there was a significant reduction in MIP from preoperative baseline to postoperative day 4; however, the MIP in the incentive spirometry group had a significantly smaller reduction in MIP compared with the control group (33.0±23.2% vs 47.2±20.1%, respectively; p=0.006, 95% confidence interval, 3.9-23.3). There was no difference between groups regarding secondary outcomes.
CONCLUSIONS


Patients in the study group had significantly better recovery of inspiratory muscle strength on day 4 post-CABG than patients in the control group. There was no significant difference between groups for either postoperative pulmonary complications or length of hospital stay.",2020,There was no significant difference between groups for either postoperative pulmonary complications or length of hospital stay.,"['patients who have undergone coronary artery bypass graft (CABG) surgery', 'Ninety (90', 'patients were included, with 47 and 43 patients assigned to the study and control groups, respectively', 'patients scheduled to undergo CABG surgery at Siriraj Hospital, Bangkok Thailand']","['postoperative combined incentive spirometry and DBE versus DBE alone', 'incentive spirometry with a deep breathing exercise (DBE', 'Incentive Spirometry', 'Coronary Artery Bypass Graft Surgery', 'incentive spirometry and DBE, and the control group received DBE only']","['recovery of inspiratory muscle strength', 'Inspiratory Muscle Strength', 'inspiratory muscle strength', 'postoperative pulmonary complication and duration of postoperative hospitalisation', 'Maximal inspiratory pressure (MIP', 'MIP', 'postoperative pulmonary complications or length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry (regime/therapy)'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises (regime/therapy)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0827976,There was no significant difference between groups for either postoperative pulmonary complications or length of hospital stay.,"[{'ForeName': 'Siriluck', 'Initials': 'S', 'LastName': 'Manapunsopee', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanitta', 'Initials': 'T', 'LastName': 'Thanakiatpinyo', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Wanchai', 'Initials': 'W', 'LastName': 'Wongkornrat', 'Affiliation': 'Cardiothoracic Division, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjamas', 'Initials': 'B', 'LastName': 'Chuaychoo', 'Affiliation': 'Division of Respiratory Diseases and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Wilawan', 'Initials': 'W', 'LastName': 'Thirapatarapong', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Electronic address: jeab_wi44@yahoo.com.'}]","Heart, lung & circulation",['10.1016/j.hlc.2019.09.009']
649,30791102,Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase III trials.,"BACKGROUND


In the U.S.A., an Investigator's Global Assessment (IGA) score of ≤ 1 (clear or almost clear skin) has been the standard measure in regulatory outcomes for registration clinical trials in atopic dermatitis (AD), including those supporting the recent approval of dupilumab.
OBJECTIVES


To evaluate the treatment effect of dupilumab in patients with IGA > 1 at the end of treatment, using other validated outcome measures for AD signs, symptoms and quality of life.
METHODS


LIBERTY AD SOLO 1 and 2 were two 16-week, randomized, double-blind trials enrolling adult patients with moderate-to-severe AD (IGA ≥ 3) inadequately controlled with topical treatment. We performed a post hoc analysis in patients receiving dupilumab 300 mg every 2 weeks (q2w) or placebo. Outcome measures in patients with IGA > 1 included Eczema Area and Severity Index (EASI), pruritus numerical rating scale (NRS), affected body surface area (BSA), Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index (DLQI). The trials were registered at ClinicalTrials.gov: NCT02277743 and NCT02277769.
RESULTS


At week 16, 278 of 449 dupilumab q2w-treated patients (median age 36·0 years) and 396 of 443 placebo-treated patients had IGA > 1. Among patients with IGA > 1 at week 16, dupilumab significantly improved several outcome measures compared with placebo: EASI (-48·9% vs. -11·3%, P < 0·001), pruritus NRS (-35·2% vs. -9·1%, P < 0·001), affected BSA (-23·1% vs. -4·5%, P < 0·001), POEM score ≥ 4-point improvement (57·4% vs. 21·0%, P < 0·001) and DLQI score ≥ 4-point improvement (59·3% vs. 24·4%, P < 0·001).
CONCLUSIONS


In patients with IGA > 1 at week 16, dupilumab induced statistically significant benefits in multiple validated outcome measures compared with placebo. The IGA ≤ 1 end point significantly underestimates clinically relevant dupilumab treatment effects.",2019,"In patients with IGA > 1 at week 16, dupilumab induced statistically significant benefits in multiple validated outcome measures compared with placebo.","['LIBERTY AD SOLO 1 and 2 were two 16-week, randomized, double-blind trials enrolling adult patients with moderate-to-severe AD (IGA ≥ 3) inadequately controlled with topical treatment', 'patients with atopic dermatitis', 'patients with IGA > 1 at the end of treatment']","['placebo', 'dupilumab 300 mg every 2 weeks (q2w) or placebo', 'Dupilumab', 'placebo: EASI', 'dupilumab']","['patients with IGA > 1 included Eczema Area and Severity Index (EASI), pruritus numerical rating scale (NRS), affected body surface area (BSA), Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index (DLQI', 'AD signs, symptoms and quality of life', 'DLQI score ≥ 4-point improvement', 'pruritus NRS', 'POEM score ≥ 4-point improvement', 'BSA']","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0222045'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C4304942', 'cui_str': 'Patient-Oriented Eczema Measure (assessment scale)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.511127,"In patients with IGA > 1 at week 16, dupilumab induced statistically significant benefits in multiple validated outcome measures compared with placebo.","[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, Preventive Medicine and Medical Social Sciences, Northwestern University Feinberg School of Medicine, NMH/Arkes Family Pavilion Suite, 1600, 676 N. Saint Clair, Chicago, IL, 60611, U.S.A.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Service de Dermatologie, Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Eczema Treatment Center of Central New Jersey, East Windsor, NJ, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Korotzer', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rizova', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17791']
650,31084994,Sertraline and Mirtazapine Versus Placebo in Subgroups of Depression in Dementia: Findings From the HTA-SADD Randomized Controlled Trial.,"OBJECTIVE


Studies have shown that antidepressants are no better than placebo in treating depression in dementia. The authors examined antidepressant efficacy in subgroups of depression in dementia with different depressive symptom profiles.
METHODS


This study focuses on exploratory secondary analyses on the randomized, parallel-group, double-blind, placebo-controlled Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial. The setting included old-age psychiatry services in nine centers in England. The participants included 326 patients meeting National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association probable/possible Alzheimer disease criteria, and Cornell Scale for Depression in Dementia (CSDD) scores of 8 or more. Intervention was placebo (n = 111), sertraline (n = 107), or mirtazapine (n = 108). Latent class analyses (LCA) on baseline CSDD items clustered participants into symptom-based subgroups. Mixed-model analysis evaluated CSDD improvement at 13 and 39 weeks by randomization in each subgroup.
RESULTS


LCA yielded 4 subgroups: severe (n = 34), psychological (n = 86), affective (n = 129), and somatic (n = 77). Mirtazapine, but not sertraline, outperformed placebo in the psychological subgroup at week 13 (adjusted estimate: -2.77 [standard error (SE) 1.16; 95% confidence interval: -5.09 to -0.46]), which remained, but lost statistical significance at week 39 (adjusted estimate: -2.97 [SE 1.59; 95% confidence interval: -6.15 to 0.20]). Neither sertraline nor mirtazapine outperformed placebo in the other subgroups.
CONCLUSION


Because of the exploratory nature of the analyses and the small sample sizes for subgroup analysis there is the need for caution in interpreting these data. Replication of the potential effects of mirtazapine in the subgroup of those with depression in dementia with ""psychological"" symptoms would be valuable. These data should not change clinical practice, but future trials should consider stratifying types of depression in dementia in secondary analyses.",2019,"Mirtazapine, but not sertraline, outperformed placebo in the psychological subgroup at week 13 (adjusted estimate:","['subgroup of those with depression in dementia with ""psychological"" symptoms', ""participants included 326 patients meeting National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association probable/possible Alzheimer disease criteria, and Cornell Scale for Depression in Dementia (CSDD) scores of 8 or more"", 'Subgroups of Depression in Dementia', 'subgroups of depression in dementia with different depressive symptom profiles']","['sertraline', 'placebo', 'standard error (SE', 'mirtazapine', 'Mirtazapine', 'Sertraline and Mirtazapine Versus Placebo']",['CSDD improvement'],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0009460', 'cui_str': 'Communicative Disorders'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]",[],326.0,0.512515,"Mirtazapine, but not sertraline, outperformed placebo in the psychological subgroup at week 13 (adjusted estimate:","[{'ForeName': 'Marij', 'Initials': 'M', 'LastName': 'Zuidersma', 'Affiliation': 'University Center of Psychiatry & Interdisciplinary Center of Psychopathology and Emotion Regulation (MZ, ROV), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Kia-Chong', 'Initials': 'KC', 'LastName': 'Chua', 'Affiliation': ""Health Service and Population Research Department (KCC), Institute of Psychiatry, Psychology & Neuroscience, King's College London, London.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hellier', 'Affiliation': ""Biostatistics & Health Informatics Department (JH), Institute of Psychiatry, Psychology & Neuroscience, King's College London, London.""}, {'ForeName': 'Richard Oude', 'Initials': 'RO', 'LastName': 'Voshaar', 'Affiliation': 'University Center of Psychiatry & Interdisciplinary Center of Psychopathology and Emotion Regulation (MZ, ROV), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Sube', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Centre for Dementia Studies (SB), Brighton & Sussex Medical School, University of Sussex, Brighton, East Sussex, United Kingdom. Electronic address: s.banerjee@bsms.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.03.021']
651,31074641,ATTAIN: Phase III study of etirinotecan pegol versus treatment of physician's choice in patients with metastatic breast cancer and brain metastases.,"The increasing incidence of breast cancer brain metastases is a major clinical problem with its associated poor prognosis and limited treatment options. The long-acting topoisomerase-1 inhibitor, etirinotecan pegol, was designed to preferentially accumulate in tumor tissue including brain metastases, providing sustained cytotoxic SN38 levels. Motivated by improved survival findings from subgroup analyses from the Phase III BEACON trial, this ongoing randomized, Phase III trial compares etirinotecan pegol to drugs commonly used for advanced breast cancer in patients with stable, treated breast cancer brain metastases who have been previously treated with an anthracycline, taxane and capecitabine. The primary end point is overall survival. Secondary end points include objective response rate, progression-free survival and time to CNS disease progression or recurrence in patients with/without CNS lesions present at study entry. Trial registration number: NCT02915744.",2019,"Secondary end points include objective response rate, progression-free survival and time to CNS disease progression or recurrence in patients with/without CNS lesions present at study entry.","['patients with metastatic breast cancer and brain metastases', 'patients with stable, treated breast cancer brain metastases who have been previously treated with an']","['etirinotecan pegol', 'anthracycline, taxane and capecitabine', ""physician's choice""]","['objective response rate, progression-free survival and time to CNS disease progression or recurrence', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3659087', 'cui_str': 'etirinotecan pegol'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007682', 'cui_str': 'CNS Diseases'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0391077,"Secondary end points include objective response rate, progression-free survival and time to CNS disease progression or recurrence in patients with/without CNS lesions present at study entry.","[{'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology, Houston, TX\xa077030, USA.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': ""Dana-Farber Cancer Institute, Center for Women's Cancers,\xa0Boston, MA 02215, USA.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Seidman', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, Bobst International Center,\xa0New York, NY 10065, USA.'}, {'ForeName': 'Carey K', 'Initials': 'CK', 'LastName': 'Anders', 'Affiliation': 'University of North Carolina School of Medicine, Duke Cancer Center,\xa0Chapel Hill, NC 27710, USA.'}, {'ForeName': 'Nuhad', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology, Houston, TX\xa077030, USA.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco, Department of Medicine (Hematology/Oncology), San Francisco, CA 94115, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': 'University of Leeds, Leeds Institute of Cancer and Pathology (LICAP), Leeds, LS2 9JT, UK.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Dieras', 'Affiliation': 'Institut Curie, Oncological Medicine Department,\xa075248, Paris, France.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Obstetrics and Gynecology,\xa020246\xa0Hamburg, Germany.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA\xa094158, USA.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Hannah', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA\xa094158, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'IOB Institute of Oncology, Quironsalud Group, 28034 Madrid & 08023 Barcelona, Spain.'}]","Future oncology (London, England)",['10.2217/fon-2019-0180']
652,31092139,Changes in Patient Activation in a Self-Management Intervention.,"The purpose of this study was to compare results using individual change in level of patient activation measure (PAM) scores, individual point change scores, and group means in an outcome analysis. We evaluated changes in PAM scores (increase in level or increase of ≥5 points) to mean group PAM scores on patients who completed a self-management intervention compared with usual care on health care utilization and health-related quality of life. The sample was a subset of 91 multimorbid patients with complete data at completion of a self-management intervention. Results indicated that using a change in points allowed for more refined analysis of change compared with level changes; however, both individual measures were more reflective of actual change than group means. When tailoring interventions, we should consider using individual change scores. Further research is needed to evaluate how best to use PAM scores to measure the impact on clinical and health care outcomes.",2020,"Results indicated that using a change in points allowed for more refined analysis of change compared with level changes; however, both individual measures were more reflective of actual change than group means.",['91 multimorbid patients with complete data at completion of a self-management intervention'],[],"['health care utilization and health-related quality of life', 'PAM scores', 'level of patient activation measure (PAM) scores, individual point change scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",[],"[{'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4075848', 'cui_str': 'Patient Activation Measure score'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0198268,"Results indicated that using a change in points allowed for more refined analysis of change compared with level changes; however, both individual measures were more reflective of actual change than group means.","[{'ForeName': 'Leeza A', 'Initials': 'LA', 'LastName': 'Struwe', 'Affiliation': 'University of Nebraska Medical Center, Lincoln, USA.'}, {'ForeName': 'Myra S', 'Initials': 'MS', 'LastName': 'Schmaderer', 'Affiliation': 'University of Nebraska Medical Center, Lincoln, USA.'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Zimmerman', 'Affiliation': 'University of Nebraska Medical Center, Lincoln, USA.'}]",Western journal of nursing research,['10.1177/0193945919848091']
653,17474185,Grey scrubs: medical dramas.,,2007,,[],[],[],[],[],[],,0.0117087,,"[{'ForeName': 'Leonard L L', 'Initials': 'LL', 'LastName': 'Yeo', 'Affiliation': 'Department of Medicine, National University Hospital, Singapore. leonard.yeo@nathealthgroup.com'}]","Annals of the Academy of Medicine, Singapore",[]
654,31734151,Efficacy of Precise Foot Massage Therapy on Pain and Anxiety Following Cardiac Surgery: Pilot Study.,"BACKGROUND


Pain is the most pervasive distressing symptom following cardiac surgery. Forty percent of postoperative cardiac patients report inadequate pain management. Undertreated acute pain results in increased anxiety, delayed wound healing, and increased chance of persistent chronic pain. Foot massage is a safe, visible complementary approach to manage acute pain following surgery.
AIM


The aim of this study is to evaluate the efficacy of integrating foot massage therapy for managing postcardiac pain.
METHOD


A randomized placebo controlled single blinded trial comparing foot massage to placebo was conducted at a large hospital in Saudi Arabia. Thirty-one patients who had undergone cardiac surgery (16 in experimental and 15 in placebo group) participated in the study. Ten-minute foot massage was delivered to the experimental group by a nurse researcher, twice during one day, within 30 minutes after receiving an opioid pain medication.
RESULTS


The findings of this study indicate that foot massage significantly (p < .05) decreases pain intensity and anxiety in patients who have undergone cardiac surgery compared with a placebo control group.
CONCLUSION


Providing non-pharmacologic interventions for pain is the responsibility of the nursing staff. Foot massage is within the scope of nursing practice and is a safe and effective manner of improving patient care. Foot massage in conjunction with pharmacological interventions is effective in improving pain and anxiety. Future studies should consider focusing on frequency, dose, feasibility, acceptability, and participants' satisfaction.",2020,"The findings of this study indicate that foot massage significantly (p < .05) decreases pain intensity and anxiety in patients who have undergone cardiac surgery compared with a placebo control group.
","['large hospital in Saudi Arabia', 'Thirty-one patients who had undergone cardiac surgery (16 in experimental and 15 in placebo group) participated in the study', 'patients who have undergone cardiac surgery']","['Foot massage', 'placebo', 'integrating foot massage therapy', 'Foot massage in conjunction with pharmacological interventions', 'Precise Foot Massage Therapy']","['Pain and Anxiety', 'pain and anxiety', 'pain intensity and anxiety', 'inadequate pain management', 'anxiety, delayed wound healing, and increased chance of persistent chronic pain']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3536731', 'cui_str': 'Massage Therapy'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",,0.158738,"The findings of this study indicate that foot massage significantly (p < .05) decreases pain intensity and anxiety in patients who have undergone cardiac surgery compared with a placebo control group.
","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Alameri', 'Affiliation': 'Department of Fundamental Nursing, College Nursing, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. Electronic address: raalamri@iau.edu.sa.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Dean', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Castner', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Volpe', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Elghoneimy', 'Affiliation': 'College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Jungquist', 'Affiliation': 'School of Nursing, The State University of New York, Buffalo, New York, USA.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.09.005']
655,31057081,Utilizing a Mobile Health Intervention to Manage Hypertension in an Underserved Community.,"This 6-month pilot randomized controlled trial examined the effectiveness of a Mobile Health (mHealth) intervention for hypertension self-monitoring and management in an underserved urban community. The four health outcomes measured included changes in systolic and diastolic blood pressure (BP), BP monitoring adherence, perceived medication adherence self-efficacy, and health-related quality of life. Thirty participants were randomly assigned to the mHealth group or a standard follow-up group; 25 participants completed the study. The mHealth group had statistically significant improvement in systolic BP decrease ( p  = .01). The mHealth group had better adherence to BP monitoring and improved perceived medication adherence self-efficacy at 6 months, compared with the standard follow-up group. The results suggest that an mHealth intervention has the potential to facilitate hypertension management in underserved urban communities.",2020,"The mHealth group had better adherence to BP monitoring and improved perceived medication adherence self-efficacy at 6 months, compared with the standard follow-up group.","['Thirty participants', 'underserved urban communities', 'underserved urban community']","['Mobile Health Intervention', 'Mobile Health (mHealth) intervention', 'mHealth intervention']","['adherence to BP monitoring and improved perceived medication adherence self-efficacy', 'systolic BP decrease', 'changes in systolic and diastolic blood pressure (BP), BP monitoring adherence, perceived medication adherence self-efficacy, and health-related quality of life']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",30.0,0.0423258,"The mHealth group had better adherence to BP monitoring and improved perceived medication adherence self-efficacy at 6 months, compared with the standard follow-up group.","[{'ForeName': 'Peijia', 'Initials': 'P', 'LastName': 'Zha', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, USA.'}, {'ForeName': 'Rubab', 'Initials': 'R', 'LastName': 'Qureshi', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, USA.'}, {'ForeName': 'Sallie', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, USA.'}, {'ForeName': 'Ying-Yu', 'Initials': 'YY', 'LastName': 'Chao', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, USA.'}, {'ForeName': 'Dula', 'Initials': 'D', 'LastName': 'Pacquiao', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Chase', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Brien-Richardson"", 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, USA.'}]",Western journal of nursing research,['10.1177/0193945919847937']
656,31733180,A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.,"BACKGROUND


Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear.
METHODS


We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns.
RESULTS


After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).
CONCLUSIONS


In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).",2020,"A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).
",['1644 patients without an established indication for oral anticoagulation after successful TAVR to receive'],"['direct factor Xa inhibitor rivaroxaban', 'transcatheter aortic-valve replacement (TAVR', 'rivaroxaban', 'rivaroxaban group) or aspirin', 'aspirin', 'Rivaroxaban', 'Transcatheter Aortic-Valve Replacement']","['major, disabling, or life-threatening bleeding', 'death or a first thromboembolic event', 'Major, disabling, or life-threatening bleeding', 'risk of bleeding', 'thromboembolic events', 'risk of death or thromboembolic complications', 'composite of death or thromboembolic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C3653500', 'cui_str': 'Direct Factor Xa Inhibitors'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",1644.0,0.430588,"A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).
","[{'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Gilard', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Giustino', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'De Backer', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ana H C', 'Initials': 'AHC', 'LastName': 'Guimarães', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Annapoorna', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'von Lewinski', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mack', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schäfer', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Seeger', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchétché', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomitzek', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Volkl', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Zazula', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ronald G M', 'Initials': 'RGM', 'LastName': 'van Amsterdam', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1911425']
657,30370463,Parental Reactivity to Disruptive Behavior in Toddlerhood: An Experimental Study.,"Disruptive child behavior is often exacerbated and maintained by negative and inconsistent parenting behavior that unwittingly reinforces disruptive behavior. One explanation for why parents render it difficult to remain positive and consistent might be the impact of disruptive child behavior on parent self-efficacy and stress. This study investigates how disruptive child behavior in a challenging parenting situation shapes parental momentary thoughts of self-efficacy and feelings of stress (i.e., perceived distress and physiological arousal), and how these in turn predict parenting behavior. We experimentally manipulated a challenging parenting situation that was designed to elicit disruptive child behavior. Specifically, we examined: (1) the effects of the challenging condition compared to a control situation on parental state self-efficacy and stress, (2) whether parents with lower trait self-efficacy and higher trait stress in daily life are most affected, and (3) how state self-efficacy and stress predict parental subsequent use of direct commands and positive affect. Parent-toddler dyads were randomly assigned to a challenging or control situation (N = 110, M age  = 30.9 months). As predicted, parents in the challenging situation, relative to control, reported less self-efficacy and more perceived distress, and showed increased physiological arousal. Self-efficacy was compromised particularly in parents with low trait self-efficacy. Our findings suggest that child disruptive behavior drives parental state self-efficacy and stress, especially momentary self-efficacy in parents who generally feel less self-efficacious.",2019,"As predicted, parents in the challenging situation, relative to control, reported less self-efficacy and more perceived distress, and showed increased physiological arousal.","['Toddlerhood', 'Parent-toddler dyads']",[],"['Self-efficacy', 'self-efficacy', 'physiological arousal']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",,0.0205832,"As predicted, parents in the challenging situation, relative to control, reported less self-efficacy and more perceived distress, and showed increased physiological arousal.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Child Development and Education and Research Priority Area YIELD, University of Amsterdam, PO Box 15780, 1001 NG, Amsterdam, the Netherlands. s.schulz@uu.nl.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Leijten', 'Affiliation': 'Child Development and Education and Research Priority Area YIELD, University of Amsterdam, PO Box 15780, 1001 NG, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'University of Pittsburgh, 4101 Sennott Square, 210 South Bouquet Street, Pittsburgh, PA, 15260, USA.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'Overbeek', 'Affiliation': 'Child Development and Education and Research Priority Area YIELD, University of Amsterdam, PO Box 15780, 1001 NG, Amsterdam, the Netherlands.'}]",Journal of abnormal child psychology,['10.1007/s10802-018-0489-4']
658,31029925,Organic beet leaves and stalk juice attenuates HDL-C reduction induced by high-fat meal in dyslipidemic patients: A pilot randomized controlled trial.,"OBJECTIVES


Beet leaves and stalks are rich in polyphenols; however, their effect on risk factors for cardiovascular disease in humans, to our knowledge, has not yet been investigated. The aim of this study was to analyze the acute effect of beet leaves and stalk juice, containing different concentrations of polyphenols, on lipemia, glycemic control, nitric oxide concentration, and blood pressure in patients with dyslipidemia after a high-fat meal.
METHODS


In a randomized double-blind, placebo-controlled, crossover pilot study, patients 20 to 59 y of age with dyslipidemia were fed a single high-fat meal supplemented with either a placebo or one of two organic beet leaves and stalk juices rich in polyphenols (32 or 77.5 mg EAG/100 mL) with a 1-wk washout. Thus, each group was composed of 13 patients. Blood samples were obtained at fasting and 30, 60, 120, and 180 min after intervention. Total cholesterol, high-density lipoprotein, triacylglycerols, glucose, insulin, nitrite and nitrate, and blood pressure were assessed at each time period. The high-fat meal increased triacylglycerol levels after 120 (P < 0.001) and 180 min (P < 0.001) and reduced high-density lipoprotein cholesterol after 60 min (P < 0.05). This reduction was attenuated in both groups that received BLS juices after 120 min (P = 0.005). A reduction in diastolic blood pressure within groups that received BLS juice was also observed.
RESULTS


There was no significant difference between groups for other biomarkers.
CONCLUSION


The beet leaves and stalk juice attenuated the reduction of high-density lipoprotein cholesterol induced by a high-fat meal.",2019,The high-fat meal increased triacylglycerol levels after 120 (P < 0.001) and 180 min (P < 0.001) and reduced high-density lipoprotein cholesterol after 60 min (P < 0.05).,"['dyslipidemic patients', 'patients with dyslipidemia after a high-fat meal', 'patients 20 to 59 y of age with dyslipidemia']","['placebo or one of two organic beet leaves and stalk juices rich in polyphenols', 'placebo']","['lipemia, glycemic control, nitric oxide concentration, and blood pressure', 'diastolic blood pressure', 'Blood samples', 'high-density lipoprotein cholesterol', 'triacylglycerol levels', 'Total cholesterol, high-density lipoprotein, triacylglycerols, glucose, insulin, nitrite and nitrate, and blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600054', 'cui_str': 'Beets'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}]","[{'cui': 'C1706412', 'cui_str': 'Lipemia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}]",,0.147581,The high-fat meal increased triacylglycerol levels after 120 (P < 0.001) and 180 min (P < 0.001) and reduced high-density lipoprotein cholesterol after 60 min (P < 0.05).,"[{'ForeName': 'Anna Paula Oliveira', 'Initials': 'APO', 'LastName': 'Gomes', 'Affiliation': 'Faculty of Nutrition, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Monallisa Alves', 'Initials': 'MA', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Nutrition, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Joyce Moreira', 'Initials': 'JM', 'LastName': 'Camargo', 'Affiliation': 'Faculty of Nutrition, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Marillya de Oliveira', 'Initials': 'MO', 'LastName': 'Araújo', 'Affiliation': 'Chemistry Institute, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Andrea Sugai', 'Initials': 'AS', 'LastName': 'Mortoza', 'Affiliation': 'Faculty of Nutrition, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'João Felipe', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Alexandre Siqueira Guedes', 'Initials': 'ASG', 'LastName': 'Coelho', 'Affiliation': 'Agronomy School, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Caroline Dario', 'Initials': 'CD', 'LastName': 'Capitani', 'Affiliation': 'Faculty of Applied Sciences, University of Campinas, Brazil.'}, {'ForeName': 'Wendell Karlos Tomazelli', 'Initials': 'WKT', 'LastName': 'Coltro', 'Affiliation': 'Chemistry Institute, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Patrícia Borges', 'Initials': 'PB', 'LastName': 'Botelho', 'Affiliation': 'Postgraduate program of the Faculty of Nutrition, Federal University of Goiás, Goiânia, Goiás, Brazil and Faculty of Health Sciences, University of Brasília, Distrito Federal, Brazil. Electronic address: Patriciabotelho@unb.br.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.03.004']
659,31599729,A Smart Mobile Health Tool Versus a Paper Action Plan to Support Self-Management of Chronic Obstructive Pulmonary Disease Exacerbations: Randomized Controlled Trial.,"BACKGROUND


Many patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs.
OBJECTIVE


This study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals.
METHODS


In a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool (intervention group) or a paper action plan (control group) when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models.
RESULTS


Of the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good.
CONCLUSIONS


This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02553096; https://clinicaltrials.gov/ct2/show/NCT02553096.",2019,"This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan.","['Chronic Obstructive Pulmonary Disease Exacerbations', 'patients with COPD', 'patients with COPD used the smart mHealth tool (intervention group) or a', '87 patients with COPD recruited from primary and secondary care centers', 'COPD patients', 'patients with chronic obstructive pulmonary disease (COPD']","['paper action plan (control group', 'smart mobile health (mHealth']","['health status, self-efficacy, self-management behavior, and health care utilization', 'exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization', 'health status, self-efficacy, self-management behavior, health care utilization, and usability', 'automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions']","[{'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3658282', 'cui_str': 'Secondary Referral Hospital'}]","[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",43.0,0.133629,"This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan.","[{'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'Boer', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bischoff', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van der Heijden', 'Affiliation': 'Institute for Computing and Information Science, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lucas', 'Affiliation': 'Institute for Computing and Information Science, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Akkermans', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vercoulen', 'Affiliation': 'Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heijdra', 'Affiliation': 'Department of Pulmonary Diseases, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Assendelft', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Tjard', 'Initials': 'T', 'LastName': 'Schermer', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}]",JMIR mHealth and uHealth,['10.2196/14408']
660,31259883,Chinese Patients With Heart Valve Replacement Do Not Benefit From Warfarin Pharmacogenetic Testing on Anticoagulation Outcomes.,"BACKGROUND


Genotype-guided warfarin dosing has been shown in some randomized trials to improve anticoagulation outcomes in individuals of European ancestry; yet, its utility in Chinese patients with heart valve replacement remains unresolved.
METHODS


A total of 2264 patients who underwent heart valve replacement at Wuhan Asia Heart Hospital were enrolled in this study. Patients were randomly divided into 2 groups, namely, a genotype-guided and a traditional clinically guided warfarin dosing group. In the genotype-guided group (n = 1134), genotyping for CYP2C9 and VKORC1 (-1639 G→A) was performed using TaqMan genotyping assay. Warfarin doses were predicted with the International Warfarin Pharmacogenetics Consortium algorithm. Patients in the control group (n = 1130) were clinically guided. The primary outcome was to compare the incidence of adverse events (major bleeding and thrombotic) during a 90-day follow-up period between 2 groups. Secondary objectives were to describe effects of the pharmacogenetic intervention on the first therapeutic-target-achieving time, the stable maintenance dose, and the hospitalization days.
RESULTS


A total of 2245 patients were included in the analysis. Forty-nine events occurred during follow-up. Genotype-guided dosing strategy did not result in a reduction in major bleeding (0.26% versus 0.63%; hazard ratio, 0.44; 95% confidence interval, 0.13-1.53; P = 0.20) and thrombotic events (0.89% versus 1.61%; hazard ratio, 0.56; 95% confidence interval, 0.27-1.17; P = 0.12) compared with clinical dosing group. Compared with traditional dosing, patients in the genotype-guided group reached their therapeutic international normalized ratio in a shorter time (3.8 ± 2.0 versus 4.4 ± 2.0 days, P < 0.001). There was no difference in hospitalization days (P = 0.28).
CONCLUSIONS


Warfarin pharmacogenetic testing according to the International Warfarin Pharmacogenetics Consortium algorithm cannot improve anticoagulation outcomes in Chinese patients with heart valve replacement.",2019,"Genotype-guided dosing strategy did not result in a reduction in major bleeding (0.26% vs 0.63%; hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.13-1.53; p=0.20), thrombotic events (0.89% vs 1.61%; HR, 0.56; 95% CI, 0.27-1.17; p=0.12) compared with clinical dosing group.","['Chinese patients with heart valve replacement', '2264 patients who underwent heart valve replacement at Wuhan Asia Heart Hospital', 'A total of 2245 patients were included in the analysis', 'Chinese patients with heart valve replacement remains unresolved']","['Warfarin', 'genotype-guided and a traditionally clinical guided warfarin dosing group', 'CYP2C9 and VKORC1', 'warfarin pharmacogenetic testing']","['thrombotic events', 'first therapeutic-target-achieving (TTA) time, the stable maintenance dose and the hospitalization days', 'hospitalization days', 'incidence of adverse events (major bleeding and thrombotic', 'major bleeding', 'therapeutic INR', 'anticoagulation outcomes']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement (procedure)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0443342', 'cui_str': 'Unresolved (qualifier value)'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1828473', 'cui_str': 'Cytochrome P450 MP-8'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Testing'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0525032', 'cui_str': 'INR'}]",2264.0,0.075269,"Genotype-guided dosing strategy did not result in a reduction in major bleeding (0.26% vs 0.63%; hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.13-1.53; p=0.20), thrombotic events (0.89% vs 1.61%; HR, 0.56; 95% CI, 0.27-1.17; p=0.12) compared with clinical dosing group.","[{'ForeName': 'Yexia', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Asia Heart Hospital, Wuhan University.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Asia Heart Hospital, Wuhan University.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Laboratory of Molecular Cardiology, Wuhan Asia Heart Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Yuanping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Laboratory of Molecular Cardiology, Wuhan Asia Heart Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Xinsheng', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Asia Heart Hospital, Wuhan University.'}, {'ForeName': 'Litao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Asia Heart Hospital, Wuhan University.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000664']
661,31726072,"""Adaptative endovascular strategy to the CloT MRI in large intracranial vessel occlusion"" (VECTOR): Study protocol of a randomized control trial.","A correlation between the susceptibility vessel sign (SVS) and red thrombi has been identified in MRI. We hypothesized that the Embotrap allow better retrieving of SVS+ thrombi. The AdaptatiVe Endovascular strategy to the CloT MRI in large intracranial vessel Occlusion (VECTOR) trial is a multicenter, prospective and randomized study designed to compare a first-line strategy combining Embotrap added to contact aspiration (CA) versus CA alone in patients with SVS+ occlusions.",2020,"The AdaptatiVe Endovascular strategy to the CloT MRI in large intracranial vessel Occlusion (VECTOR) trial is a multicenter, prospective and randomized study designed to compare a first line strategy combining Embotrap added to contact aspiration (CA) versus CA alone in patients with SVS+ occlusions.",['patients with SVS+ occlusions'],"['Embotrap added to contact aspiration (CA) versus CA alone', 'CloT MRI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",[],,0.0304938,"The AdaptatiVe Endovascular strategy to the CloT MRI in large intracranial vessel Occlusion (VECTOR) trial is a multicenter, prospective and randomized study designed to compare a first line strategy combining Embotrap added to contact aspiration (CA) versus CA alone in patients with SVS+ occlusions.","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Janot', 'Affiliation': 'Department of Neuroradiology, University Hospital of Tours, 2, boulevard Tonnellé, 37000 Tours, France. Electronic address: kevin.janot@hotmail.com.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'University Hospital of Nancy, France.'}, {'ForeName': 'Basile', 'Initials': 'B', 'LastName': 'Kerleroux', 'Affiliation': 'Department of Neuroradiology, University Hospital of Tours, 2, boulevard Tonnellé, 37000 Tours, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Boulouis', 'Affiliation': 'Saint-Anne Hospital, Paris, France.'}, {'ForeName': 'Eimad', 'Initials': 'E', 'LastName': 'Shotar', 'Affiliation': 'La Pitie-Salpetrière Hospital, Paris, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Premat', 'Affiliation': 'La Pitie-Salpetrière Hospital, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Eugene', 'Affiliation': 'University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Dargazanli', 'Affiliation': 'University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Chalumeau', 'Affiliation': 'Bicêtre Hospital, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': ""L'Allinec"", 'Affiliation': 'University Hospital of Angers, Angers, France.'}, {'ForeName': 'Wagih', 'Initials': 'W', 'LastName': 'Benhassen', 'Affiliation': 'Saint-Anne Hospital, Paris, France.'}, {'ForeName': 'Gaultier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lebras', 'Affiliation': 'Regional Hospital of Vannes, Vannes, France.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Detraz', 'Affiliation': 'University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Ognard', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Personnic', 'Affiliation': 'University Hospital of Lille, Lille, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Chivot', 'Affiliation': 'University Hospital of Amiens, Amiens, France.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cappucci', 'Affiliation': 'University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Géraud', 'Initials': 'G', 'LastName': 'Forestier', 'Affiliation': 'University Hospital of Limoges, Limoges, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Soize', 'Affiliation': 'University Hospital of Reims, Reims, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bourdain', 'Affiliation': 'Regional Hospital of Bayonne, Bayonne, France.'}, {'ForeName': 'Arthuro', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Foch Hospital, Suresnes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, University Hospital of Lille, Lille, France.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Foch Hospital, Suresnes, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Rouchaud', 'Affiliation': 'University Hospital of Limoges, Limoges, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Bourcier', 'Affiliation': 'University Hospital of Nantes, Nantes, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neuroradiology = Journal de neuroradiologie,['10.1016/j.neurad.2019.11.001']
662,30987852,"Safety and immunogenicity of a respiratory syncytial virus fusion glycoprotein F subunit vaccine in healthy adults: Results of a phase 1, randomized, observer-blind, controlled, dosage-escalation study.","INTRODUCTION


Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infections in infants. An investigational vaccine using an engineered recombinant RSV fusion glycoprotein in its post-fusion conformation (RSV F subunit vaccine) has been developed to protect young infants via maternal immunization. This first-in-human, phase I, observer-blind study (NCT02298179) evaluated the safety and immunogenicity of different dosages and formulations of RSV F subunit vaccine in healthy non-pregnant women and men aged 18-45 years.
METHODS


Participants were enrolled (1:1:1) in a stepwise dosage-escalation manner into three cohorts to receive RSV F subunit vaccine containing 45 µg, 90 µg and 135 μg of RSV F glycoprotein. Within each cohort, participants were randomized (1:1:1:1) to receive two doses of RSV F subunit vaccine with (aluminum hydroxide or MF59) or without adjuvant, or placebo, ≥28 days apart. Safety (until day 365 post-dose 2), anti-RSV neutralizing antibodies (NAbs) and serum total binding antibodies to RSV F protein (until day 181 post-dose 1) were evaluated.
RESULTS


All formulations were well-tolerated. No vaccine-related serious adverse events were reported. All participants were seropositive for anti-RSV NAbs at baseline, with geometric mean titers (GMTs) ranging from 184 (95% confidence interval [CI]: 127-266) to 380 (95% CI: 272-531). At 28 days post-dose 1, anti-RSV NAb GMTs in vaccine recipients ranged from 893 (95% CI: 702-1,136) to 1,602 (95% CI: 1,243-2,064). No booster effect was observed, but immune responses were maintained above pre-vaccination levels for six months post-dose 1. Ratios of RSV F total binding antibodies fold changes to NAb fold changes ranged from 2.79 to 4.12 at 28 days post-dose 1. The impact of the adjuvant was limited.
CONCLUSIONS


A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.",2019,A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.,"['healthy non-pregnant women and men aged 18-45\u202fyears', 'infants', 'Participants were enrolled (1:1:1) in a stepwise dosage-escalation manner into three cohorts to receive', 'young infants via maternal immunization', 'healthy adults']","['RSV F subunit vaccine with (aluminum hydroxide or MF59) or without adjuvant, or placebo', 'RSV F subunit vaccine containing 45\u202fµg, 90\u202fµg and 135\u202fμg of RSV F glycoprotein', 'RSV subunit F vaccine', 'respiratory syncytial virus fusion glycoprotein F subunit vaccine', 'RSV F subunit vaccine']","['Safety and immunogenicity', 'safety and immunogenicity', 'anti-RSV neutralizing antibodies (NAbs) and serum total binding antibodies to RSV F protein', 'tolerated']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.411656,A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.,"[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Centre for Vaccinology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: Geert.LerouxRoels@UGent.be.'}, {'ForeName': 'Fien', 'Initials': 'F', 'LastName': 'De Boever', 'Affiliation': 'Centre for Vaccinology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: Fien.DeBoever@uzgent.be.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Maes', 'Affiliation': 'Centre for Vaccinology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: Cathy.Maes@uzgent.be.'}, {'ForeName': 'Thi Lien-Anh', 'Initials': 'TL', 'LastName': 'Nguyen', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Sherryl', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'GSK, 14200 Shady Grove Rd, Rockville, MD 20850, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gonzalez Lopez', 'Affiliation': 'GSK, 14200 Shady Grove Rd, Rockville, MD 20850, USA. Electronic address: antonio.y.gonzalez@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.04.011']
663,31219949,Pharmacokinetics of Enteric-Coated Mycophenolate Sodium in Lupus Nephritis (POEMSLUN).,"BACKGROUND


Mycophenolate mofetil or enteric-coated mycophenolate sodium (EC-MPS) and steroids are used for induction and maintenance therapy in severe lupus nephritis. Blood concentrations of mycophenolic acid (MPA), the active metabolite of these drugs, vary among patients with lupus nephritis. The objective of this study was to examine whether concentration-controlled (CC) dosing (through therapeutic drug monitoring) of EC-MPS results in a higher proportion of participants achieving target exposure of MPA compared with fixed-dosing (FD). An additional aim of the study was to evaluate the influence of CC dosing on clinical outcomes.
METHODS


Nineteen participants were randomly assigned either to the FD or CC group. All the participants were eligible to have free and total measurements of MPA over a period of 8-12 hours on 3 different occasions. Area under the concentration-time curve between 0 and 12 hours (AUC0-12) was calculated using noncompartmental methods. Dose of EC-MPS was titrated according to AUC0-12 in the CC group.
RESULTS


Thirty-two AUC0-12 measurements were obtained from 9 FD and 9 CC participants. Large inter-patient variability was observed in both groups but was more pronounced in the FD group. There were no significant differences between FD and CC participants in any pharmacokinetic parameters across the study visits, except for total C0 (FD 2.0 ± 0.3 mg/L versus CC 1.1 ± 0.3; P = 0.01) and dose-normalized C0 (FD 2.9 ± 0.2 mg/L/g versus CC 2.1 ± 0.7 mg/L/g; P = 0.04) at the second visit and total AUC0-12 (FD 66.6 ± 6.0 mg·h/L versus CC 35.2 ± 11.4 mg·h/L; P = 0.03) at the third visit. At the first study visit, 33.3% of the FD and 11.1% of the CC participants achieved the target area under the concentration-time curve (P = 0.58). From the second visit, none of the FD participants, compared with all the CC participants, achieved target AUC0-12 (P = 0.01). More CC participants achieved remission compared with FD participants (absolute difference of -22.2, 95% confidence interval (Equation is included in full-text article.)0.19 to 0.55; P = 0.62). The mean free MPA AUC0-12 was significantly lower in those who had complete remission.
CONCLUSIONS


CC participants reached target AUC0-12 quicker. Larger studies are required to test clinical efficacy.",2019,There were no significant differences between FD and CC participants in any pharmacokinetic parameters across the study visits except for total C0 (FD 2.0 ± 0.3 mg/L vs. CC 1.1 ± 0.3; p = 0.01) and dose-normalised C0 (FD 2.9 ± 0.2 mg/L/g vs. CC 2.1 ± 0.7 mg/L/g; p = 0.04) at the second visit and total AUC0-12 (FD 66.6 ± 6.0 mg[BULLET OPERATOR]h/L vs. CC 35.2 ± 11.4 mg[BULLET OPERATOR]h/L; p = 0.03) at the third visit.,"['severe lupus nephritis (LN', 'Nineteen participants']","['enteric coated mycophenolate sodium', 'CC', 'EC-MPS', 'Mycophenolate mofetil (MMF) or enteric coated mycophenolate sodium (EC-MPS) and steroids', 'FD or CC']","['remission', 'Blood concentrations of mycophenolic acid (MPA', 'mean free MPA AUC0-12', 'concentration-time curve', 'Large interpatient variability']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024143', 'cui_str': 'Lupus Glomerulonephritis'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",19.0,0.0369186,There were no significant differences between FD and CC participants in any pharmacokinetic parameters across the study visits except for total C0 (FD 2.0 ± 0.3 mg/L vs. CC 1.1 ± 0.3; p = 0.01) and dose-normalised C0 (FD 2.9 ± 0.2 mg/L/g vs. CC 2.1 ± 0.7 mg/L/g; p = 0.04) at the second visit and total AUC0-12 (FD 66.6 ± 6.0 mg[BULLET OPERATOR]h/L vs. CC 35.2 ± 11.4 mg[BULLET OPERATOR]h/L; p = 0.03) at the third visit.,"[{'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Mohd H', 'Initials': 'MH', 'LastName': 'Abdul-Aziz', 'Affiliation': 'Faculty of Medicine, University of Queensland Centre for Clinical Research (UQCCR), The University of Queensland.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'John', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Brett C', 'Initials': 'BC', 'LastName': 'McWhinney', 'Affiliation': ""Pathology Queensland, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Fassett', 'Affiliation': 'Faculty of Medicine, University of Queensland Centre for Clinical Research (UQCCR), The University of Queensland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Healy', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kubler', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lim', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lipman', 'Affiliation': ""Intensive Care Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Purvey', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Roberts', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Reyaldeen', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Ungerer', 'Affiliation': ""Pathology Queensland, Royal Brisbane and Women's Hospital.""}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Roberts', 'Affiliation': 'Faculty of Medicine, University of Queensland Centre for Clinical Research (UQCCR), The University of Queensland.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000658']
664,31425441,Generation and Validation of a Limited Sampling Strategy to Monitor Mycophenolic Acid Exposure in Children With Nephrotic Syndrome.,"BACKGROUND


Mycophenolate mofetil (MMF) plays an increasingly important role in the treatment of children with nephrotic syndrome, especially in steroid sparing protocols. Recent publications show the relationship of exposure to its active moiety mycophenolic acid (MPA) and clinical efficacy. Performance of full-time pharmacokinetic (PK) profiles, however, is inconvenient and laborious. Established limited sampling strategies (LSS) to estimate the area under the concentration (AUC) versus time curve of MPA (MPA-AUC) in pediatric renal transplant recipients cannot be easily transferred to children suffering from nephrotic syndrome, mainly because of the lack of concomitant immunosuppressive therapy. We therefore aimed for the generation and validation of a LSS to estimate MPA exposure to facilitate therapeutic drug monitoring in children with nephrotic syndrome.
METHODS


We performed 27 complete PK profiles in 23 children in remission [mean age (±SD):12.3 ± 4.26 years] to generate and validate an LSS. Sampling time points were before administration (C0) and 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours after the administration of MMF. MPA was measured by enzyme multiplied immunoassay technique. There was no concomitant treatment with calcineurin inhibitors.
RESULTS


Mean daily dose of MMF was 927 ± 209 mg/m of body surface area resulting in a mean MPA-AUC0-12 value of 59.2 ± 29.3 mg × h/L and a predose level of 3.03 ± 2.24 mg/L. Between-patient variability of dose-normalized MPA-AUC0-12 was high (coefficient of variation: 45.5%). Correlation of predose levels with the corresponding MPA-AUC0-12 was moderate (r = 0.59) in a subgroup of 18 patients (20 PK profiles, generation group). An algorithm based on 3 PK sampling time points during the first 2 hours after MMF dosing (estimated AUC0-12 = 8.7 + 4.63 × C0 + 1.90 × C1 + 1.52 × C2) was able to predict MPA-AUC with a low percentage prediction error (3.88%) and a good correlation of determination (r = 0.90). Validation of this algorithm in a randomized separate group of 6 patients (7 PK profiles, validation group) resulted in comparably good correlation (r = 0.95) and low percentage prediction error (5.57%).
CONCLUSIONS


An abbreviated profile within the first 2 hours after MMF dosing gives a good estimate of MPA exposure in children with nephrotic syndrome and hence has the potential to optimize MMF therapy.",2019,"Correlation of pre-dose levels with the corresponding MPA-AUC0-12 was moderate (r=0.59) in a subgroup of 18 patients (20 PK profiles, generation group).","['children with nephrotic syndrome', '23 children in remission [mean age (±SD):12.3±4.26 years', 'pediatric renal transplant recipients']","['MMF', 'mycophenolic acid exposure', 'mycophenolate mofetil (MMF', 'Mycophenolate mofetil (MMF']","['MPA', 'Performance of full time pharmacokinetic (PK) profiles']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",20.0,0.048593,"Correlation of pre-dose levels with the corresponding MPA-AUC0-12 was moderate (r=0.59) in a subgroup of 18 patients (20 PK profiles, generation group).","[{'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Benz', 'Affiliation': ""Pediatric Nephrology, Children's and Adolescents' Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne.""}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Ehren', 'Affiliation': ""Pediatric Nephrology, Children's and Adolescents' Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Kleinert', 'Affiliation': ""Pediatric Nephrology, Children's Hospital, Memmingen.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Department of Therapeutic Drug Monitoring, Faculty of Medicine and University Hospital Cologne, Cologne.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gellermann', 'Affiliation': 'Department of Pediatric Nephrology, Charité Universitätsmedizin Berlin CVdK, Berlin.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fehrenbach', 'Affiliation': ""Pediatric Nephrology, Children's Hospital, Memmingen.""}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': ""Pediatric Endocrinology, Dr. von Haunersches Kinderspital, University Children's Hospital, LMU, Munich, Germany.""}, {'ForeName': 'Lutz T', 'Initials': 'LT', 'LastName': 'Weber', 'Affiliation': ""Pediatric Nephrology, Children's and Adolescents' Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne.""}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000671']
665,31670004,Proactive telemedicine monitoring of sleep apnea treatment improves adherence in people with stroke- a randomized controlled trial (HOPES study).,"OBJECTIVE


Obstructive sleep apnea (OSA) impacts stroke recovery and outcome negatively. Although its identification and treatment are part of the current stroke guidelines, standard management with positive airway pressure (PAP) therapy is not routinely performed and adherence rates are very low. The purpose of this study was to determine whether PAP adherence can be improved by a PAP training strategy during in-hospital rehabilitation combined with a telemedicine monitoring system after discharge.
METHODS


In this study, we performed a controlled trial (RCT) on standard PAP treatment (SG) as compared with proactive telemonitored PAP treatment (TG). After three months and one year, PAP adherence (min of use per day) and clinical outcome variables were compared.
RESULTS


In 33 (47.1%) out of 70 patients diagnosed with therapy-relevant OSA [70% male, 62 (5) years, body mass index (BMI) 30 (4) kg/m 2 , Barthel Index 90 (20), NIHSS 3 (3)] in-hospital PAP titration was performed. Subsequently, they were randomized to SG or TG. Drop-out rates after three months and after one year were 12% and 30%, respectively, with no differences between the groups. After three months, telemonitored patients used the PAP device 76 min longer per night (SG: 299 (76), TG: 375 (86) minutes per night; p = 0.017), after one year there was no significant difference.
CONCLUSION


People with stroke and therapy-relevant OSA who accept PAP therapy should receive additional telemedicine monitoring at least for three months. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov; Unique identifier: NCT02748681.",2019,"Drop-out rates after three months and after one year were 12% and 30%, respectively, with no differences between the groups.","['People with stroke and therapy-relevant OSA who accept PAP therapy', 'people with stroke', '70 patients diagnosed with therapy-relevant OSA [70% male, 62 (5) years, body mass index (BMI) 30 (4) kg/m 2 , Barthel Index 90 (20), NIHSS 3 (3)] in-hospital PAP titration was performed']","['TG', 'positive airway pressure (PAP) therapy', 'proactive telemonitored PAP treatment (TG', 'standard PAP treatment (SG', 'Proactive telemedicine monitoring of sleep apnea treatment']",['PAP adherence'],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]",[],70.0,0.0907421,"Drop-out rates after three months and after one year were 12% and 30%, respectively, with no differences between the groups.","[{'ForeName': 'Stefan T', 'Initials': 'ST', 'LastName': 'Kotzian', 'Affiliation': 'Neurologisches Rehabilitationszentrum Rosenhügel, Vienna, Austria.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Saletu', 'Affiliation': 'Neurologisches Rehabilitationszentrum Rosenhügel, Vienna, Austria; Department of Sleep Medicine, LKH Graz II, Austria. Electronic address: michael.saletu@gmail.com.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Schwarzinger', 'Affiliation': 'Neurologisches Rehabilitationszentrum Rosenhügel, Vienna, Austria.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Haider', 'Affiliation': 'Neurologisches Rehabilitationszentrum Rosenhügel, Vienna, Austria; Medical University of Vienna, Department of Social and Preventive Medicine, Center for Public Health, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Spatt', 'Affiliation': 'Neurologisches Rehabilitationszentrum Rosenhügel, Vienna, Austria.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Kranz', 'Affiliation': 'Neurologisches Rehabilitationszentrum Rosenhügel, Vienna, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Saletu', 'Affiliation': 'Medical University of Vienna, Department of Psychiatry and Psychotherapy, Austria.'}]",Sleep medicine,['10.1016/j.sleep.2019.06.004']
666,31695168,Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder.,"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear. It is also unclear whether functional connectivity can be used as a predictive biomarker of treatment response. Here, we used whole-brain functional connectivity analysis to identify neural signatures of remission following antidepressant treatment, and to identify connectomic predictors of treatment response. 163 MDD and 62 healthy individuals underwent functional MRI during pre-treatment baseline and 8-week follow-up sessions. Patients were randomized to escitalopram, sertraline or venlafaxine-XR antidepressants and assessed at follow-up for remission. Baseline measures of intrinsic functional connectivity between each pair of 333 regions were analyzed to identify pre-treatment connectomic features that distinguish remitters from non-remitters. We then interrogated these connectomic differences to determine if they changed post-treatment, distinguished patients from controls, and were modulated by medication type. Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks. This baseline hypo-connectivity for non-remitters also distinguished them from controls and increased following treatment. In contrast, connectivity for remitters was higher than controls at baseline and also following remission, suggesting a trait-like connectomic characteristic. Increased functional connectivity within and between large-scale intrinsic brain networks may characterize acute recovery with antidepressants in depression.",2020,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.",['163 MDD and 62 healthy individuals underwent'],"['escitalopram, sertraline or venlafaxine-XR antidepressants', 'functional MRI']","['connectivity for remitters', 'intrinsic functional connectivity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",163.0,0.0349942,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.","[{'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. m.korgaonkar@sydney.edu.au.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fornito', 'Affiliation': 'Brain and Mental Health Research Hub, Turner Institute for Brain and Mental Health & Monash Biomedical Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. leawilliams@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0574-2']
667,31718998,Detection of optical coherence tomography-defined thin-cap fibroatheroma in the coronary artery using deep learning.,"AIMS


The aim of this study was to develop a deep learning model for classifying frames with versus without optical coherence tomography (OCT)-derived thin-cap fibroatheroma (TCFA).
METHODS AND RESULTS


A total of 602 coronary lesions from 602 angina patients were randomised into training and test sets in a 4:1 ratio. A DenseNet model was developed to classify OCT frames with or without OCT-derived TCFA. Gradient-weighted class activation mapping was used to visualise the area of attention. In the training sample (35,678 frames of 480 lesions), the model with fivefold cross-validation had an overall accuracy of 91.6±1.7%, sensitivity of 88.7±3.4%, and specificity of 91.8±2.0% (averaged AUC=0.96±0.01) in predicting the presence of TCFA. In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback. The correlation between the %TCFA burden per vessel predicted by the model compared with that identified by experts was significant (r=0.87, p<0.001). The region of attention was localised at the site of the thin cap in 93.4% of TCFA-containing frames. Total computational time per pullback was 2.1±0.3 seconds.
CONCLUSIONS


A deep learning algorithm can accurately detect an OCT-TCFA with high reproducibility. The time-saving computerised process may assist clinicians to recognise high-risk lesions easily and to make decisions in the catheterisation laboratory.",2020,"In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback.",['Total 602 coronary lesions from 602 angina patients'],"['Optical Coherence Tomography-Defined Thin-Cap Fibroatheroma', 'optical coherence tomography (OCT)-derived thin-cap fibroatheroma (TCFA']","['Total computational time per a pullback', 'overall accuracy at the frame level']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C2936351', 'cui_str': 'Fibroatheromatous Plaques'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",602.0,0.0357016,"In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback.","[{'ForeName': 'Hyun-Seok', 'Initials': 'HS', 'LastName': 'Min', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hyeong', 'Initials': 'JH', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Soo-Jin', 'Initials': 'SJ', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'June-Goo', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hyungjoo', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Seung-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Young-Hak', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Cheol Whan', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Seong-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00487']
668,31678965,Effects of self-monitoring devices on blood pressure in older adults with hypertension and diabetes: a randomised controlled trial.,"BACKGROUND


Hypertension and diabetes frequently coexist, which results in the difficulty of hypertension control in community-dwelling elderly adults who lack effective prevention and control strategies. The aim of this study is to determine whether a combined pedometer and home blood pressure monitoring (HBPM) programme could improve blood pressure (BP) among community-dwelling elderly adults with hypertension and diabetes.
METHODS


The trial was a 2×2 factorial randomised clinical trial that recruited 180 community-dwelling elderly people (aged ≥60) with hypertension and diabetes in Tianjin, China. Participants were randomly assigned to control, pedometer, HBPM, and pedometer+HBPM groups. Intervention period was 12 months. The coprimary outcomes of the study were systolic and diastolic BP; the secondary outcomes included the proportion of patients with controlled hypertension. BP was measured twice in the right arm using a mercurial sphygmomanometer. The mean of these two measurements was taken as the BP value.
RESULTS


At 12 months, compared with the control group, the adjusted differences in least squares mean (95% CI) in systolic and diastolic BP changes for pedometer, HBPM, and pedometer+HBPM groups were -4.2 (-8.4 to 0.1), -2.7 (-6.9 to 1.5) and -8.1 (-12.3 to -3.9) mm Hg (p<0.01); -3.2 (-5.2 to -1.1), -0.1(-2.1 to 1.9) and -3.6 (-5.6 to -1.5) mm Hg (p<0.001), respectively; the adjusted difference in percentage (95% CI) in the controlled hypertension (BP <140/90 mm Hg) for pedometer, HBPM and pedometer+HBPM groups were 7.5 (-12.2 to 27.1), 9.9 (-10.4 to 30.3) and 23.1 (5.0 to 41.1) (p=0.09).
CONCLUSION


Combination pedometer and HBPM interventions can significantly decrease BP levels in elderly adults with hypertension and diabetes.
TRIALS REGISTRATION NUMBER


UMIN000021613.",2020,"At 12 months, compared with the control group, the adjusted differences in least squares mean (95% CI) in systolic and diastolic BP changes for pedometer, HBPM, and pedometer+HBPM groups were -4.2 (-8.4 to 0.1), -2.7","['elderly adults with hypertension and diabetes', '180 community-dwelling elderly people (aged ≥60) with hypertension and diabetes in Tianjin, China', 'older adults with hypertension and diabetes', 'community-dwelling elderly adults with hypertension and diabetes', 'community-dwelling elderly adults']","['self-monitoring devices', 'combined pedometer and home blood pressure monitoring (HBPM) programme', 'Combination pedometer and HBPM interventions']","['BP levels', 'blood pressure', 'systolic and diastolic BP', 'blood pressure (BP', 'BP', 'systolic and diastolic BP changes', 'proportion of patients with controlled hypertension']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1449681', 'cui_str': 'Blood Pressure Monitoring, Home'}, {'cui': 'C0649948', 'cui_str': 'HBPM'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",180.0,0.0699171,"At 12 months, compared with the control group, the adjusted differences in least squares mean (95% CI) in systolic and diastolic BP changes for pedometer, HBPM, and pedometer+HBPM groups were -4.2 (-8.4 to 0.1), -2.7","[{'ForeName': 'Yeqing', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Meng', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Health Management Centre, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Health Management Centre, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Health Management Centre, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yaogang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Kaijun', 'Initials': 'K', 'LastName': 'Niu', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China nkj0809@gmail.com.'}]",Journal of epidemiology and community health,['10.1136/jech-2019-212531']
669,30962121,The effect of muscle fatigue on wrist joint position sense in healthy adults.,"STUDY DESIGN


Pretest and posttest experimental study.
INTRODUCTION


The effect of muscle fatigue on wrist joint position sense (JPS) has yet to be determined.
PURPOSE OF THE STUDY


The primary aim was to determine whether muscle fatigue affects wrist JPS in healthy adults. The secondary aims were to compare the effect of muscle fatigue on younger and older adults JPS and determine the association between JPS rate of change and total muscle fatigue (TMF) rates postexercise.
METHODS


Forty male and female healthy adults were assigned into younger (18-40 years) and older (41-65 years) groups. Preexercise and postexercise testing consisted of active wrist JPS, handgrip, and wrist extensor strength assessments. Muscle fatigue was induced via a calibrated gripper and wrist extension dumbbell exercises. Dependent variables were the JPS rate of change (ie, preexercise and postexercise), TMF rate (ie, grip and wrist extension average strength decline), and Borg Rating of Perceived Exertion scale scores.
RESULTS


Postexercise wrist JPS test scores were significantly higher than preexercise. Exercises induced statistically significant TMF rates and Borg Rating of Perceived Exertion scores among all participants. No statistically significant age-group differences on JPS rate of change, and TMF rate was found. A statistically significant mild correlation (r = 0.425) existed between JPS rate of change and TMF rates.
DISCUSSION


Postexercise fatigue significantly impairs wrist JPS in both younger and older adults. On average, an 18% muscle strength decline led to 215% wrist JPS deficit.
CONCLUSIONS


Significant wrist proprioception deficits persist for ≤5 min following exertional exercises, regardless of age level.",2020,Exercises induced statistically significant TMF rates and Borg Rating of Perceived Exertion scores among all participants.,"['younger and older adults', 'healthy adults', 'Forty male and female healthy adults were assigned into younger (18-40 years) and older (41-65 years) groups']","['wrist joint position sense (JPS', 'Preexercise and postexercise testing consisted of active wrist JPS, handgrip, and wrist extensor strength assessments']","['Muscle fatigue', 'TMF rates and Borg Rating of Perceived Exertion scores', 'Postexercise wrist JPS test scores', 'JPS rate of change and TMF rates', 'wrist joint position sense', 'JPS rate of change, and TMF rate', 'JPS rate of change (ie, preexercise and postexercise), TMF rate (ie, grip and wrist extension average strength decline), and Borg Rating of Perceived Exertion scale scores']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1322271', 'cui_str': 'Wrist joint structure (body structure)'}, {'cui': 'C0234219', 'cui_str': 'Position Sense'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure (body structure)'}, {'cui': 'C0234219', 'cui_str': 'Position Sense'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0222045'}]",40.0,0.0706804,Exercises induced statistically significant TMF rates and Borg Rating of Perceived Exertion scores among all participants.,"[{'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Karagiannopoulos', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA. Electronic address: karagiannopoulosc@gmail.com.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kahan', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.03.004']
670,31004517,Different routes and formulations of melatonin in critically ill patients. A pharmacokinetic randomized study.,"BACKGROUND AND OBJECTIVES


Critically ill patients present reduced endogenous melatonin blood levels, and they might benefit from its exogenous supplementation. The aim of this research was to evaluate the feasibility of different routes of administration and drug formulations of melatonin. The efficiency of absorption was assessed as well as the adequacy in achieving and maintaining the physiological nocturnal blood peak.
METHODS


Twenty-one high-risk critically ill patients were randomly assigned to receive melatonin either: (a) per os, as a standard tablet (ST-OS), (b) per os, as a suspension in solid lipid nanoparticles (SLN-OS) or c) transdermal (TD), by applying a jellified melatonin microemulsion (μE) on the skin (μE-TD). SLN-OS and μE-TD were lipid-based colloidal systems. The endogenous melatonin blood values were observed for 24 hours; subsequently, melatonin 3 mg was administered and pharmacokinetics was studied for 24 hours further.
RESULTS


In both groups that received ST-OS and SLN-OS, the median time-to-peak blood concentration was 0.5 hours; however, the area under the curve (AUC) after administration of SLN-OS was significantly higher than after ST-OS (157386 [65732-193653] vs 44441 [22319-90705] pg/mL*hours, P = 0.048). μE-TD presented a delayed time-to-peak blood concentration (4 hours), a lower bioavailability (AUC: 3142 [1344-14573] pg/mL*hours) and reached pharmacological peak concentration (388 [132-1583] pg/mL).
CONCLUSIONS


SLN-melatonin enterally administered offers favourable pharmacokinetics in critically ill patients, with higher bioavailability with respect to the standard formulation; μE-TD provided effective pharmacological blood levels, with a time-concentration profile more similar to the physiological melatonin pattern.",2019,"μE-TD presented a delayed time-to-peak blood concentration (4 hours), a lower bioavailability (AUC: 3142 [1344-14573] pg/mL*hours) and reached pharmacological peak concentration (388 [132-1583] pg/mL).
","['Twenty-one high-risk critically ill patients', 'critically ill patients']","['melatonin', 'suspension in solid lipid nanoparticles (SLN-OS) or c) transdermal (TD), by applying a jellified melatonin microemulsion (μE', 'SLN-melatonin']","['median time-to-peak blood concentration', 'endogenous melatonin blood values', 'efficiency of absorption', 'delayed time-to-peak blood concentration']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0005768'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0522486', 'cui_str': 'Delay time (qualifier value)'}]",21.0,0.0856916,"μE-TD presented a delayed time-to-peak blood concentration (4 hours), a lower bioavailability (AUC: 3142 [1344-14573] pg/mL*hours) and reached pharmacological peak concentration (388 [132-1583] pg/mL).
","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mistraletti', 'Affiliation': 'Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Paroni', 'Affiliation': 'Department of Health Science, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Umbrello', 'Affiliation': 'S.C. Anesthesia and Intensive Care, ASST Santi Paolo e Carlo, Ospedale San Paolo-Polo Universitario, Milano, Italy.'}, {'ForeName': 'Bedrana', 'Initials': 'B', 'LastName': 'Moro Salihovic', 'Affiliation': 'Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Coppola', 'Affiliation': 'S.C. Anesthesia and Intensive Care, ASST Santi Paolo e Carlo, Ospedale San Paolo-Polo Universitario, Milano, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Froio', 'Affiliation': 'S.C. Anesthesia and Intensive Care, ASST Santi Paolo e Carlo, Ospedale San Paolo-Polo Universitario, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Finati', 'Affiliation': 'Department of Health Science, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gasco', 'Affiliation': 'Nanovector srl, Torino, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Savoca', 'Affiliation': 'Chemical Engineering Department, Politecnico di Milano, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Manca', 'Affiliation': 'Chemical Engineering Department, Politecnico di Milano, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Chiumello', 'Affiliation': 'S.C. Anesthesia and Intensive Care, ASST Santi Paolo e Carlo, Ospedale San Paolo-Polo Universitario, Milano, Italy.'}, {'ForeName': 'Russel J', 'Initials': 'RJ', 'LastName': 'Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science Centre, San Antonio, Texas.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Iapichino', 'Affiliation': 'Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milano, Italy.'}]",Clinical endocrinology,['10.1111/cen.13993']
671,28958023,A Comparison of Self-report Indices of Major Mobility Disability to Failure on the 400-m Walk Test: The LIFE Study.,"Background


The objective assessment of major mobility disability (objective MMD) by a 400-m walk test (400 MWT) is important but not always practical. Previous research on the relationship between self-reported MMD (SR MMD) and objective MMD is sparse and limited to cross-sectional data.
Methods


We evaluated agreement between SR MMD and objective MMD using longitudinal data from the Lifestyle Interventions for Elders (LIFE) study. The SR MMD indices were defined based on having a lot of difficulty or inability to walk a quarter of a mile (SR-1/4MILE), walk several blocks (SR-BLOCKS), and climb one flight of stairs (SR-STAIRS).
Results


Using objective MMD as the gold standard, SR-1/4MILE and SR-BLOCKS had relatively low sensitivity (around 0.4) and high specificity (around 0.9) for prevalence. Their overall sensitivity and specificity for cumulative incident objective MMD were approximately 0.6 and 0.8, respectively. While the annual probability of staying MMD free was similar for objective MMD, SR-1/4MILE, and SR-BLOCKS (90% for all), the probability of recovering from SR MMD was higher (50%) than that of objective MMD (22%). The development of objective MMD (439 events), SR-1/4MILE (356 events), and SR-BLOCKS (379 events) had a similar trajectory over time with substantially overlapping survival curves. SR-STAIRS generally did not agree well with objective MMD. Incorporating SR-STAIRS with either SR-1/4MILE or SR-BLOCKS did not significantly improve the agreement between SR MMD and objective MMD.
Conclusions


Simple SR-1/4MILE and SR-BLOCKS are reasonable candidates to define MMD if the primary outcome of interest is incident MMD.",2018,"While the annual probability of staying MMD free was similar for objective MMD, SR-1/4MILE, and SR-BLOCKS (90% for all), the probability of recovering from SR MMD was higher (50%) than that of objective MMD (22%).",['Elders (LIFE) study'],[],"['overall sensitivity and specificity for cumulative incident objective MMD', 'major mobility disability (objective MMD', 'probability of recovering from SR MMD']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}]",,0.0385587,"While the annual probability of staying MMD free was similar for objective MMD, SR-1/4MILE, and SR-BLOCKS (90% for all), the probability of recovering from SR MMD was higher (50%) than that of objective MMD (22%).","[{'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine/Geriatrics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Health Research & Policy Department and Department of Medicine (Stanford Prevention Research Center), Stanford University School of Medicine, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conroy', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer Human Nutrition Research Center in Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glx153']
672,31869626,Impact of an external ventricular drain bundle and limited duration antibiotic prophylaxis on drain-related infections and antibiotic resistance.,"BACKGROUND/OBJECTIVE


Systemic prophylactic antibiotics have been used to reduce the rate of neurosurgical drain-related infections (DRIs) but the optimal duration is unknown. The Neurocritical Care Society Consensus Statement for External Ventricular Drain (EVD) management recommends a single antibiotic dose preoperatively. Data regarding antibiotic management for other neurosurgical drains (e.g. subgaleal and subdural drains) are lacking. Previously at our institution antibiotics were continued for the duration of drain placement. In 2016 an EVD bundle was implemented to standardize nursing care, and antibiotic duration was changed to one preoperative dose for all neurosurgical drains. The objective of this study was to compare the incidence of DRI, non-DRI, and antibiotic resistance before and after the implementation of an EVD bundle and limited duration antibiotics.
PATIENTS AND METHODS


This was a single center, quasi-experimental study that included patients status post EVD or craniotomy/craniectomy with subgaleal or subdural drain placement. The pre-intervention period was June 2014 through May 2015 and the post-intervention period was January 2017 through December 2017.
RESULTS


Ninety-one patients were included in the pre-intervention group and 54 in the post-intervention group. The use of limited duration antibiotics (< 48 h) was 14.3 % in the pre-intervention group and 96.3 % in the post-intervention group (p < 0.001). Five DRIs were identified in the pre-intervention group and 3 in the post-intervention group (5.5 % vs 5.6 %, p = 1.00). Of patients who developed a non-DRI, 77.5 % had a resistant non-DRI in the pre-intervention group compared to 48 % in the post-intervention group (p = 0.01). The rates of resistant DRI (80 % vs 66.7 %, p = 1.00) and Clostridium difficile infection (1.1 % vs 3.7 %, p = 0.56) were similar between groups.
CONCLUSIONS


Implementation of an EVD bundle and limited duration antibiotics reduced antibiotic exposure with no associated increase in risk of DRI. Rates of resistant non-DRI were significantly lower in the post-intervention group.",2020,"The rates of resistant DRI (80 % vs 66.7 %, p = 1.00) andClostridium difficile infection (1.1 % vs 3.7 %, p = 0.56) were similar between groups.
",['Ninety-one patients were included in the pre-intervention group and 54 in the post-intervention group'],"['External Ventricular Drain ', 'external ventricular drain bundle and limited duration antibiotic prophylaxis', 'EVD or craniotomy/craniectomy with subgaleal or subdural drain placement']","['Five DRIs', 'rates of resistant DRI', 'incidence of DRI, non-DRI, and antibiotic resistance', 'andClostridium difficile infection', 'risk of DRI', 'Rates of resistant non-DRI', 'resistant non-DRI', 'drain-related infections and antibiotic resistance']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0195897', 'cui_str': 'Craniectomy'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}]",91.0,0.0696455,"The rates of resistant DRI (80 % vs 66.7 %, p = 1.00) andClostridium difficile infection (1.1 % vs 3.7 %, p = 0.56) were similar between groups.
","[{'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Whyte', 'Affiliation': 'Christiana Care Health System, 4755 Ogletown-Stanton Rd., Newark, DE 19718, United States. Electronic address: Colleen.J.Whyte@gmail.com.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Alhasani', 'Affiliation': 'Christiana Care Health System, 4755 Ogletown-Stanton Rd., Newark, DE 19718, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Caplan', 'Affiliation': 'Christiana Care Health System, 4755 Ogletown-Stanton Rd., Newark, DE 19718, United States.'}, {'ForeName': 'Andrea P', 'Initials': 'AP', 'LastName': 'Tully', 'Affiliation': 'Christiana Care Health System, 4755 Ogletown-Stanton Rd., Newark, DE 19718, United States.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2019.105641']
673,31031314,Short- and long-term results after laparoscopic floppy Nissen fundoplication in elderly versus non-elderly patients.,"Background


Laparoscopic anti-reflux surgery could be of benefit in a subset of elderly patients with gastroesophageal reflux disease. However, there are few reports that have evaluated the long-term results. This study examined the effects of age on the short- and long-term (for at least 5 years) outcomes after laparoscopic Nissen fundoplication (LNF).
Patients and Methods


Patients were divided into four groups as follows: young (18-49); adult (50-69); and elderly (70-84), and very elderly (85-91). The database (recorded prospectively) included operating duration, conversion, intra- and early post-operative complication and late outcomes. Mean follow-up was 14.5 years (range 5-24 years).
Results


Five hundred and sixty-nine patients met the inclusion criteria: young n = 219 (38.4%); adult n = 248 (43.5%); elderly n = 91 (16.0%) and very elderly n = 11 (1.9%). Hiatal hernia (type I and III) was significantly less frequent in young and adult patients (P < 0.0001). The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients. The hospital stay, conversion (5.4%), intra-operative and early post-operative complications were not influenced by age. Dysphagia was evenly distributed among the groups. Forty-eight (8.4%) patients had recurrence: 15 in the young group (6.8%), 18 in the adult group (7.2%), 11 in the elderly group (12%) and 4 in the very elderly group (36.3%) (P < 0.0001).
Conclusions


Age does not influence short- and long-term outcomes following LNF. Control of reflux in the elderly is worse than adult patients. Therefore, ageing is a relative contraindication to LNF.",2020,The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients.,"['Five hundred and sixty-nine patients met the inclusion criteria: young n = 219 (38.4%); adult n = 248 (43.5%); elderly n = 91 (16.0%) and very elderly n = 11 (1.9', 'elderly patients with gastroesophageal reflux disease', 'elderly versus non-elderly patients', 'young (18-49); adult (50-69); and elderly (70-84), and very elderly (85-91']","['LNF', '\n\n\nLaparoscopic anti-reflux surgery', 'laparoscopic Nissen fundoplication (LNF', 'laparoscopic floppy Nissen fundoplication']","['Hiatal hernia (type I and III', 'hiatal hernia repair', 'operating duration, conversion, intra- and early post-operative complication and late outcomes', 'hospital stay, conversion (5.4%), intra-operative and early post-operative complications', 'recurrence', 'Dysphagia']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]","[{'cui': 'C0399651', 'cui_str': 'Antireflux operation (procedure)'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0857516', 'cui_str': 'Floppy'}]","[{'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",569.0,0.0250195,The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients.,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Schietroma', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Colozzi', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Romano', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pessia', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Giuliani', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Vicentini', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Carlo Luigi', 'Initials': 'CL', 'LastName': 'Recchia', 'Affiliation': 'Department of Surgery, Hospital SS. Trinità, Sora, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carlei', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_269_18']
674,31031325,A prospective randomized controlled trial comparing conventional Intuitive® procedure card recommended port placement with the modified Indian (Manipal) technique.,"Introduction


The da Vinci ®  X hybrid systems (Intuitive Surgical ® , Sunnyvale CA) provides standard sites recommendations for port placement during robotic surgery; including that for colorectal procedures. The author's encountered challenges while adhering to the provided instructions, such as clash of instruments and arms and need for additional ports, and hence to overcome these challenges attempted a few innovative technical modifications. The surgical results as well as merits of the revised Indian (Manipal) port placement with single docking technique are presented here.
Methods


Twenty patients underwent robotic rectal resection at the Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, India, between December 2017 and June 2018. A randomised controlled study was conducted to compare the two techniques. Ten patients were operated using hybrid da Vinci ®  'X' system using the manufacturer's recommendations and 10 by the modified Indian (Manipal) port placement with a single docking technique.
Result and Conclusions


The Indian (Manipal) modifications of port placements are optimal for colorectal procedures such as low anterior resection as well as for ultralow anterior resections. The intraoperative parameters compared between the recommendations of the Intuitive ®  (da Vinci ®  systems) and attempted modifications demonstrated statistically significant advantages with the use of the revised techniques. The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.",2020,"The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.","['Twenty patients underwent robotic rectal resection at the Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, India, between December 2017 and June 2018']","[""hybrid da Vinci ®  'X' system using the manufacturer's recommendations and 10 by the modified Indian (Manipal) port placement with a single docking technique"", 'conventional Intuitive® procedure card recommended port placement with the modified Indian (Manipal) technique']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1515090', 'cui_str': 'Surgical Oncology'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",[],10.0,0.0180383,"The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.","[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Somashekhar', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Deshpande', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Ashwin', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gangasani', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_18_19']
675,31017104,"Re: Kristian D. Stensland, Harras Zaid, Mark Broadwin, et al. Comparative Effectiveness of Treatment Strategies for Squamous Cell Carcinoma of the Bladder. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2018.11.003.",,2019,,['Squamous Cell Carcinoma of the Bladder'],[],[],"[{'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}]",[],[],,0.0189906,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Department of Urology, Urological Research Institute, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy; Department of Urology, Luzerner Kantonsspital, Luzern, Switzerland. Electronic address: marco.moschini87@gmail.com.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zamboni', 'Affiliation': 'Department of Urology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Mattei', 'Affiliation': 'Department of Urology, Luzerner Kantonsspital, Luzern, Switzerland.'}]",European urology oncology,['10.1016/j.euo.2019.01.003']
676,30221597,Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.,"BACKGROUND


Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk.
METHODS


From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability; results for this end point are reported in another article in the Journal. Secondary end points included major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure).
RESULTS


Of the 19,114 persons who were enrolled in the trial, 9525 were assigned to receive aspirin and 9589 to receive placebo. After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).
CONCLUSIONS


The use of low-dose aspirin as a primary prevention strategy in older adults resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).",2018,"The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).
","['From 2010 through 2014', '19,114 persons who were enrolled in the trial', 'older persons', 'enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability', 'older adults', 'Healthy Elderly']","['Aspirin', 'enteric-coated aspirin or placebo', 'aspirin', 'placebo']","['rate of cardiovascular disease', 'rate of major hemorrhage', 'risk of major hemorrhage', 'Cardiovascular Events and Bleeding', 'composite of death, dementia, or persistent physical disability', 'cardiovascular disease', 'major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",9525.0,0.34536,"The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).
","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Abhayaratna', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Sharyn M', 'Initials': 'SM', 'LastName': 'Fitzgerald', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Trevaks', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Colin I', 'Initials': 'CI', 'LastName': 'Johnston', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Radziszewska', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jelinek', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Mobin', 'Initials': 'M', 'LastName': 'Malik', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Eaton', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Brauer', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Cloud', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mahady', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Satterfield', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grimm', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1805819']
677,31596612,Comparative Efficacy on Flexible Ureteroscopy Lithotripsy and Miniaturized Percutaneous Nephrolithotomy for the Treatment of Medium-Sized Lower-Pole Renal Calculi.,"Objective:  To demonstrate the safety and efficacy of flexible ureteroscopy lithotripsy (FURL) and miniaturized percutaneous nephrolithotomy (MPCNL) through the comparative studies in treating medium-sized lower-pole renal calculi.  Methods:  Two hundred and twenty eligible patients with lower-pole renal calculi (1-2 cm) were enrolled and further randomly assigned into FURL group and MPCNL group. Patients' demographics, preoperative characteristics, intraoperative and postoperative complications, stone-free rate, and comfort and pain indicated by Bruggrmann Comfort Scale (BCS) and visual analog scale (VAS) were evaluated and recorded. Trauma index such as white blood cells, C-reactive protein (CRP), and interleukin (IL)-6 were also detected.  Results:  The stone-free rate and the operating time were comparable in FURL and MPCNL groups. Intraoperative and postoperative complication analysis showed that blood loss and hospital stay were significantly lower in the FURL group compared with MPCNL group. No significant difference in minor pelvic perforation, false passage, hemoglobin drop, persistent hematuria, ureteral perforation, moderate fever, urosepsis, and postoperative serum creatinine level was observed. However, as to comfort and pain indicated by BCS and VAS and stress indicated by CRP and IL-6, FURL was superior to MPCNL.  Conclusion:  FURL could be a better alternative surgical method to MPCNL with similar curative effect and less blood loss and hospital stay.",2019,FURL could be a better alternative surgical method to MPCNL with similar curative effect and less blood loss and hospital stay.,"['Medium-Sized Lower-Pole Renal Calculi', 'Two hundred and twenty eligible patients with lower-pole renal calculi (1-2\u2009cm']","['Flexible Ureteroscopy Lithotripsy and Miniaturized Percutaneous Nephrolithotomy', 'MPCNL', 'FURL group and MPCNL', 'flexible ureteroscopy lithotripsy (FURL) and miniaturized percutaneous nephrolithotomy (MPCNL', 'FURL']","['minor pelvic perforation, false passage, hemoglobin drop, persistent hematuria, ureteral perforation, moderate fever, urosepsis, and postoperative serum creatinine level', ""Patients' demographics, preoperative characteristics, intraoperative and postoperative complications, stone-free rate, and comfort and pain indicated by Bruggrmann Comfort Scale (BCS) and visual analog scale (VAS"", 'Trauma index such as white blood cells, C-reactive protein (CRP), and interleukin (IL)-6', 'blood loss and hospital stay', 'stone-free rate and the operating time', 'safety and efficacy']","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337815', 'cui_str': 'Poles (ethnic group)'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0522566', 'cui_str': 'False passage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0559750', 'cui_str': 'Persistent hematuria (disorder)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0149801', 'cui_str': 'Sepsis due to urinary tract infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451546', 'cui_str': 'Trauma index (assessment scale)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",220.0,0.0363077,FURL could be a better alternative surgical method to MPCNL with similar curative effect and less blood loss and hospital stay.,"[{'ForeName': 'Lianchao', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Ningchen', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}]",Journal of endourology,['10.1089/end.2019.0504']
678,30946270,"Comparison of the Effects of Eccentric, Concentric, and Eccentric-Concentric Isotonic Resistance Training at Two Velocities on Strength and Muscle Hypertrophy.","Ünlü, G, Çevikol, C, and Melekoğlu, T. Comparison of the effects of eccentric, concentric, and eccentric-concentric isotonic resistance training at two velocities on strength and muscle hypertrophy. J Strength Cond Res 34(2): 337-344, 2020-The aim of this study was to compare the effects of concentric, eccentric, and eccentric-concentric isotonic resistance training at both fast and slow velocities to determine whether contraction modality affects muscle strength and hypertrophy. Forty-one young, healthy males (mean age 21.1 ± 1.8 years; height 178.9 ± 6.1 cm; body mass 70.5 ± 9.8 kg; and body mass index 22.0 ± 2.6 kg·m) were randomly assigned for 12 weeks to 1 of 5 resistance training groups to perform leg extension exercises 3 days a week (fast-eccentric; fast-concentric [FC]; slow-eccentric [SE]; slow-concentric; and concentric-eccentric [CE], 30°·s for slow and 180°·s for fast contractions), or to a nontraining control group (CG). Isotonic strength (1 repetition maximum [1RM]), isokinetic strength (peak torque), and quadriceps femoris muscle volume were measured before and after the 12 weeks of training program. In the early phase of the training period (first 3 weeks), the 1RM values of SE, FC, and CE increased remarkably (19.70, 13.73, and 19.35%, respectively; p < 0.05). Significant increases compared with the CG were found for muscle isotonic strength (∼25-41%, p < 0.001) and isokinetic peak torque at 60°·s (∼13-32%, p < 0.05) in all training groups after the 12 weeks of the training period. No statistically significant interactions between the group and time were found on isokinetic peak torques at 180°·s and muscle volume. Our results, therefore, suggest that all the training modalities in our study have the potential to induce isotonic strength gain in knee extensors, and there is insufficient evidence for the superiority of any specific mode of muscle contraction or velocity.",2020,No statistically significant interactions between the group and time were found on isokinetic peak torques at 180°·s and muscle volume.,"['Forty-one young, healthy males (mean age 21.1 ± 1.8 years; height 178.9 ± 6.1 cm; body mass 70.5 ± 9.8 kg; and body mass index 22.0 ± 2.6 kg·m']","['J Strength Cond Res XX(X', '5 resistance training groups to perform leg extension exercises 3 days a week (fast-eccentric; fast-concentric [FC]; slow-eccentric [SE]; slow-concentric; and concentric-eccentric [CE], 30°·s for slow and 180°·s for fast contractions), or to a nontraining control group (CG', 'Eccentric, Concentric, and Eccentric-Concentric Isotonic Resistance Training', 'concentric, eccentric, and eccentric-concentric isotonic resistance training']","['1RM values of SE, FC, and CE', 'isokinetic peak torque', 'Isotonic strength (1 repetition maximum [1RM]), isokinetic strength (peak torque), and quadriceps femoris muscle volume', 'isokinetic peak torques', 'muscle isotonic strength', 'strength and muscle hypertrophy', 'Strength and Muscle Hypertrophy']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy (finding)'}]",,0.0199286,No statistically significant interactions between the group and time were found on isokinetic peak torques at 180°·s and muscle volume.,"[{'ForeName': 'Gürcan', 'Initials': 'G', 'LastName': 'Ünlü', 'Affiliation': 'Department of Physical Education and Sports, Middle East Technical University, Ankara, Turkey.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Çevikol', 'Affiliation': 'Faculty of Medicine, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Melekoğlu', 'Affiliation': 'Faculty of Sports Sciences, Akdeniz University, Antalya, Turkey.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003086']
679,30946274,Concurrent Training and Detraining: The Influence of Different Aerobic Intensities.,"Sousa, AC, Neiva, HP, Gil, MH, Izquierdo, M, Rodríguez-Rosell, D, Marques, MC, and Marinho, DA. Concurrent training and detraining: the influence of different aerobic intensities. J Strength Cond Res 34(9): 2565-2574, 2020-The aim of this study was to verify the effects of different aerobic intensities combined with the same resistance training on strength and aerobic performances. Thirty-nine men were randomly assigned to a low-intensity group (LIG), moderate-intensity group (MIG), high-intensity group (HIG), and a control group. The training program consisted of full squat, jumps, sprints, and running at 80% (LIG), 90% (MIG), or 100% (HIG) of the maximal aerobic speed for 16-20 minutes. The training period lasted for 8 weeks, followed by 4 weeks of detraining. Evaluations included 20-m sprints (0-10 m: T10; 0-20 m: T20), shuttle run, countermovement jump (CMJ), and strength (1RMest) in full squat. There were significant improvements from pre-training to post-training in T10 (LIG: 4%; MIG: 5%; HIG: 2%), T20 (3%; 4%; 2%), CMJ (9%; 10%; 7%), 1RMest (13%; 7%; 8%), and oxygen uptake (V[Combining Dot Above]O2max; 10%; 11%; 10%). Comparing the changes between the experimental groups, 1RMest gains were significantly higher in the LIG than HIG (5%) or MIG (6%). Furthermore, there was a tendency for higher gains in LIG and MIG compared with HIG, with ""possibly"" or ""likely"" positive effects in T10, T20, and CMJ. Detraining resulted in performance decrements, but minimal losses were found for V[Combining Dot Above]O2max in LIG (-1%). Concurrent training seems to be beneficial for strength and aerobic development regardless of the aerobic training intensity. However, choosing lower intensities can lead to increased strength and is recommended when the cardiorespiratory gains should be maintained for longer.",2020,"Detraining resulted in performance decrements, but minimal losses were found for V[Combining",['Thirty-nine men'],"['V[Combining', 'Concurrent Training and Detraining', 'J Strength Cond Res XX(X', 'Concurrent training and detraining', 'low-intensity group (LIG), moderate-intensity group (MIG), high-intensity group (HIG), and a control group', 'aerobic intensities combined with the same resistance training']","['1RMest gains', 'Sousa, AC, Neiva, HP, Gil, MH, Izquierdo, M, Rodríguez-Rosell, D, Marques, MC, and Marinho, DA', 'shuttle run, countermovement jump (CMJ), and strength (1RMest) in full squat', '1RMest', 'oxygen uptake', 'strength and aerobic performances']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0524558', 'cui_str': 'Sousa'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",39.0,0.0183097,"Detraining resulted in performance decrements, but minimal losses were found for V[Combining","[{'ForeName': 'António C', 'Initials': 'AC', 'LastName': 'Sousa', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, UBI, Covilhã, Portugal.'}, {'ForeName': 'Henrique P', 'Initials': 'HP', 'LastName': 'Neiva', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, UBI, Covilhã, Portugal.'}, {'ForeName': 'Maria H', 'Initials': 'MH', 'LastName': 'Gil', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, UBI, Covilhã, Portugal.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarre, Navarre, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Rosell', 'Affiliation': 'Research Center on Physical and Athletic Performance, Pablo de Olavide University, Seville, Spain.'}, {'ForeName': 'Mário C', 'Initials': 'MC', 'LastName': 'Marques', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, UBI, Covilhã, Portugal.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, UBI, Covilhã, Portugal.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002874']
680,30908577,"Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study.","BACKGROUND


This study aimed to evaluate the wireless Freedom Spinal Cord Stimulator (WSCS) System for the treatment of chronic back and/or leg pain associated with failed back surgery syndrome (FBSS) refractory to standard medical treatment utilizing 10-kHz stimulation (high-frequency [HF]) in comparison with 10-1,500-Hz stimulation (low-frequency [LF]) waveforms.
METHODS


Ninety-nine subjects were randomized in a 1:1 ratio to receive either HF or LF stimulation waveforms utilizing the same Freedom WSCS System. All subjects were implanted with two 8-electrode arrays in the exact same anatomical positions within the dorsal epidural spinal column, with the top electrode positioned at the T8 and T9 vertebrae levels, respectively, and the wireless receiver placed under the skin in a subcutaneous pocket.
RESULTS


Seventy-two (HF: N = 38; LF: N = 34) subjects had completed the six-month follow-up after an initial 30-day trial period at the time of this report. For both the HF and LF arms, mean visual analog scale (VAS) scores for back and leg pain decreased significantly: 77% and 76%, respectively, for the HF arm and 64% and 64%, respectively, for the LF arm. In addition, most subjects experienced significant improvements in VAS, Oswestry Disability Index, European Quality of Life 5 Dimension questionnaire, Patient Global Impression of Change, and sleep duration.
CONCLUSIONS


These preliminary results demonstrate that WSCS devices can reduce FBSS chronic pain substantially with both LF and HF stimulation waveforms over a seven-month period (30-day trial period and six-month post-trial evaluation).",2019,"For both the HF and LF arms, mean visual analog scale (VAS) scores for back and leg pain decreased significantly: 77% and 76%, respectively, for the HF arm and 64% and 64%, respectively, for the LF arm.","['chronic back and/or leg pain associated with failed back surgery syndrome (FBSS', 'Seventy-two', 'Failed Back Surgery Syndrome Subjects', 'Ninety-nine subjects']","['10-kHz stimulation (high-frequency [HF', 'wireless Freedom Spinal Cord Stimulator (WSCS) System', 'WSCS devices', 'LF: N\u2009', 'Multiwaveform Low-Frequency Spinal Cord Stimulation', 'HF or LF stimulation waveforms utilizing the same Freedom WSCS System', 'Wireless High-Frequency Spinal Cord Stimulation (10 kHz']","['FBSS chronic pain', 'VAS, Oswestry Disability Index, European Quality of Life 5 Dimension questionnaire, Patient Global Impression of Change, and sleep duration', 'mean visual analog scale (VAS) scores for back and leg pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}]","[{'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0450448', 'cui_str': 'Waveforms (qualifier value)'}]","[{'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}]",99.0,0.110682,"For both the HF and LF arms, mean visual analog scale (VAS) scores for back and leg pain decreased significantly: 77% and 76%, respectively, for the HF arm and 64% and 64%, respectively, for the LF arm.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bolash', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Creamer', 'Affiliation': 'Central Florida Pain Centers, Orlando, Florida.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': ""Carolina's Pain Institute, Winston-Salem, North Carolina.""}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Vahedifar', 'Affiliation': 'Nuvo Spine and Sports Institute & Ortho Regenerative Center, Beverly Hills, California.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Calodney', 'Affiliation': 'Precision Spine Care, Tyler, Texas.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Fox', 'Affiliation': 'Anesthesia Pain Care Consultants, Tamarac, Florida.'}, {'ForeName': 'Cuneyt', 'Initials': 'C', 'LastName': 'Özaktay', 'Affiliation': 'Anesthesia Pain Care Consultants, Tamarac, Florida.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'National Institute of Pain, Lutz, Florida.'}, {'ForeName': 'Niek', 'Initials': 'N', 'LastName': 'Vanquathem', 'Affiliation': 'Pompano Beach, Florida, USA.'}, {'ForeName': 'Mezaun', 'Initials': 'M', 'LastName': 'Yasin', 'Affiliation': 'Anesthesia Pain Care Consultants, Tamarac, Florida.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz019']
681,31702992,Pressure Injuries Treated With Anodal and Cathodal High-voltage Electrical Stimulation: the Effect on Blood Serum Concentration of Cytokines and Growth Factors in Patients With Neurological Injuries. A Randomized Clinical Study.,"It remains unclear whether electrical currents can affect biological factors that determine chronic wound healing in humans.
PURPOSE


The aim of this study was to determine whether anodal and cathodal high-voltage monophasic pulsed currents (HVMPC) provided to the area of a pressure injury (PI) change the blood level of cytokines (interleukin [IL]-1β, IL-10, and tumor necrosis factor [TNF]-α) and growth factors (insulin-like growth factor [IGF]-1 and transforming growth factor [TGF]-β1) in patients with neurological injuries and whether the level of circulatory cytokines and growth factors correlates with PI healing progression.
METHODS


This study was part of a randomized clinical trial on the effects of HVMPC on PI healing. All patients with neurological injuries (spinal cord injury, ischemic stroke, and blunt trauma to the head) and a stage 2, stage 3, or stage 4 PI of at least 4 weeks' duration hospitalized in one rehabilitation center were eligible to participate if older than 18 years of age and willing to consent to donating blood samples. Exclusion criteria included local contraindications to electrical stimulation (cancer, electronic implants, osteomyelitis, tunneling, necrotic wounds), PIs requiring surgical intervention, patients with poorly controlled diabetes mellitus (HbA1C > 7%), critical wound infection, and/or allergies to standard wound treatment. Participants were randomly assigned to 1 of 3 groups: anodal (AG) or cathodal (CG) HVMPC treatment (154 μs; 100 Hz; 360 µC/sec; 1.08 C/day) or a placebo (PG, sham) applied for 50 minutes a day, 5 days per week, for 8 weeks. TNF-α, IL-1β, IL-10, TGF-β1, and IGF-1 levels in blood serum were assessed using the immunoenzyme method (ELISA) and by chemiluminescence, respectively, at baseline and week 4. Wound surface area measurements were obtained at baseline and week 4 and analyzed using a digitizer connected to a personal computer. Statistical analyses were performed using the maximum-likelihood chi-squared test, the analysis of variance Kruskal-Wallis test, the Kruskal-Wallis post-hoc test, and Spearman's rank order correlation; the level of significance was set at P ≤.05.
RESULTS


Among the 43 participants, 15 were randomized to AG (mean age 53.87 ± 13.30 years), 13 to CG (mean age 51.08 ± 20.43 years), and 15 to PG treatment (mean age 51.20 ± 14.47 years). Most PIs were located in the sacral region (12, 74.42%) and were stage 3 (11, 67.44%). Wound surface area baseline size ranged from 1.00 cm2 to 58.04 cm2. At baseline, none of the variables were significantly different. After 4 weeks, the concentration of IL-10 decreased in all groups (AG: 9.8%, CG: 38.54%, PG: 27.42%), but the decrease was smaller in the AG than CG group (P = .0046). The ratio of pro-inflammatory IL-10 to anti-inflammatory TNF-α increased 27.29% in the AG and decreased 26.79% in the CG and 18.56% in the PG groups. Differences between AG and CG and AG and PG were significant (AG compared to CG, P = .0009; AG compared to PG, P = .0054). Other percentage changes in cytokine and growth factor concentration were not statistically significant between groups. In the AG, the decrease of TNF-α and IL-1β concentrations correlated positively with the decrease of PI size (P <.05).
CONCLUSION


Anodal HVMPC elevates IL-10/TNF-α in blood serum. The decrease of TNF-α and IL-1β concentrations in blood serum correlates with a decrease of PI wound area. More research is needed to determine whether the changes induced by anodal HVMPC improve PI healing and to determine whether and how different electrical currents affect the activity of biological agents responsible for specific wound healing phases, both within wounds and in patients' blood. In clinical practice, anodal HVMPC should be used to increase the ratio of anti-inflammatory IL-10 to pro-inflammatory TNF-α , which may promote healing.",2019,The decrease of TNF-α and IL-1β concentrations in blood serum correlates with a decrease of PI wound area.,"[""All patients with neurological injuries (spinal cord injury, ischemic stroke, and blunt trauma to the head) and a stage 2, stage 3, or stage 4 PI of at least 4 weeks' duration hospitalized in one rehabilitation center were eligible to participate if older than 18 years of age and willing to consent to donating blood samples"", '43 participants, 15 were randomized to AG (mean age 53.87 ± 13.30 years), 13 to CG (mean age 51.08 ± 20.43 years), and 15 to PG treatment (mean age 51.20 ± 14.47 years', 'Exclusion criteria included local contraindications to electrical stimulation (cancer, electronic implants, osteomyelitis, tunneling, necrotic wounds), PIs requiring surgical intervention, patients with poorly controlled diabetes mellitus (HbA1C > 7%), critical wound infection, and/or allergies to standard wound treatment', 'Patients With Neurological Injuries', 'patients with neurological injuries']","['Anodal HVMPC elevates IL-10/TNF-α', 'anodal and cathodal high-voltage monophasic pulsed currents (HVMPC', 'anodal (AG) or cathodal (CG) HVMPC treatment', 'placebo', 'Anodal and Cathodal High-voltage Electrical Stimulation', 'HVMPC']","['concentration of IL-10', 'ratio of pro-inflammatory IL-10 to anti-inflammatory TNF-α', 'AG and CG and AG and PG', 'blood level of cytokines (interleukin [IL]-1β, IL-10, and tumor necrosis factor [TNF]-α) and growth factors (insulin-like growth factor [IGF]-1 and transforming growth factor [TGF]-β1', 'cytokine and growth factor concentration', 'PI size', 'PI healing', 'TNF-α and IL-1β concentrations', 'TNF-α, IL-1β, IL-10, TGF-β1, and IGF-1 levels in blood serum']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751792', 'cui_str': 'Injuries, Nervous System'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272654', 'cui_str': 'Wound care management'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205186', 'cui_str': 'Monophasic (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",43.0,0.0556076,The decrease of TNF-α and IL-1β concentrations in blood serum correlates with a decrease of PI wound area.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Polak', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Luther C', 'Initials': 'LC', 'LastName': 'Kloth', 'Affiliation': 'Marquette University, Milwaukee, WI.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Paczula', 'Affiliation': 'Rehabilitation Center ""Repty,"" Tarnowskie Gory, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Nawrat-Szoltysik', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kucio', 'Affiliation': 'Multispecialty Hospital, Siemianowice Slaskie, Poland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Manasar', 'Affiliation': 'Silesian Medical Laboratories, Katowice, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Blaszczak', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Janikowska', 'Affiliation': 'Medical University of Silesia, Poland.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Mazurek', 'Affiliation': 'Medical University of Silesia, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Malecki', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kucio', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}]",Wound management & prevention,[]
682,30879954,Two parenteral amino acid solutions and plasma levels of amino acids in the neonate: A randomized trial.,"OBJECTIVE


In neonates on total parenteral nutrition (TPN), amino acids may be a risk factor for developing total parenteral nutrition-associated cholestasis (TPNAC). We aimed, first, to compare methionine, cysteine, and taurine plasma levels between neonates on TPN who were receiving an intravenous amino acid solution based on a breast milk aminogram and those on an intravenous solution of pediatric amino acids based on an umbilical cord aminogram, and second, to determine the frequency of TPNAC.
METHODS


A double-blind randomized controlled trial was conducted. Ninety-four neonates with a birthweight of 1000g or more and a gestational age of 30 wk or older were admitted and enrolled. Blood samples were obtained at 0, 7, and 14 d of TPN, and plasma amino acid concentrations were determined by ultra-high-resolution liquid chromatography. Continuous variables were compared using the Wilcoxon rank-sum test or Student's t test; categorical variables were compared using the Fisher exact test.
RESULTS


Thirty-five neonates completed the study (Primene, n = 14; TrophAmine, n = 21). On day 14, methionine plasma concentrations were significantly lower in the Primene group than in the TrophAmine group (27 µmol/L versus 32.9 µmol/L, P = 0.044); the taurine concentration was significantly higher in the same group (72.4 µmol/L versus 45.3 µmol/L, P < 0.0001). There were no differences in TPNAC incidence.
CONCLUSIONS


Administering an intravenous solution of pediatric amino acids based on the umbilical cord aminogram yielded a higher taurine and lower methionine plasma concentration than did administering a similar solution based on the breast milk aminogram.",2019,"On day 14, methionine plasma concentrations were significantly lower in the Primene group than in the TrophAmine group (27 µmol/L versus 32.9 µmol/L, P = 0.044); the taurine concentration was significantly higher in the same group (72.4 µmol/L versus 45.3 µmol/L, P < 0.0001).","['Ninety-four neonates with a birthweight of 1000g or more and a gestational age of 30 wk or older were admitted and enrolled', 'neonate', 'neonates on TPN who were receiving an', 'Thirty-five neonates completed the study (Primene, n\u202f=\u202f14; TrophAmine, n\u202f=\u202f21']","['parenteral amino acid solutions', 'total parenteral nutrition (TPN), amino acids', 'TrophAmine', 'intravenous amino acid solution']","['taurine concentration', 'methionine plasma concentrations', 'plasma amino acid concentrations', 'TPNAC incidence']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0147020', 'cui_str': 'Trophamine'}]","[{'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}, {'cui': 'C0147020', 'cui_str': 'Trophamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",94.0,0.1177,"On day 14, methionine plasma concentrations were significantly lower in the Primene group than in the TrophAmine group (27 µmol/L versus 32.9 µmol/L, P = 0.044); the taurine concentration was significantly higher in the same group (72.4 µmol/L versus 45.3 µmol/L, P < 0.0001).","[{'ForeName': 'María Salomé', 'Initials': 'MS', 'LastName': 'Anaya-Flórez', 'Affiliation': 'Department of Parenteral and Enteral Nutrition, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Barbosa-Cortés', 'Affiliation': 'Medical Unit of Nutrition Research, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico. Electronic address: bcmariade@hotmail.com.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Villasis-Keever', 'Affiliation': 'Unit of Analysis and Synthesis of the Evidence, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Aguilar-Monroy', 'Affiliation': 'Medical Unit of Nutrition Research, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Montalvo-Velarde', 'Affiliation': 'Medical Unit of Nutrition Research, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Mardia', 'Initials': 'M', 'LastName': 'López-Alarcón', 'Affiliation': 'Medical Unit of Nutrition Research, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Lledias-Corona', 'Affiliation': 'Department of Parenteral and Enteral Nutrition, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Huerta-Tecanhuey', 'Affiliation': 'Department of Parenteral and Enteral Nutrition, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maldonado-Hernández', 'Affiliation': 'Medical Unit of Nutrition Research, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Madrigal-Muñiz', 'Affiliation': 'Neonatal Intensive Care Unit, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'González-Cabello', 'Affiliation': 'Neonatal Intensive Care Unit, Pediatric Hospital, 21st Century National Medical Center, Mexican Institute of Social Security (IMSS), Mexico City, Mexico.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2018.12.006']
683,30710258,Intraoperative use of dexmedetomidine for the prevention of emergence agitation and postoperative delirium in thoracic surgery: a randomized-controlled trial.,"PURPOSE


We investigated whether preventive use of dexmedetomidine during surgery was effective for reducing emergence agitation and postoperative delirium.
METHODS


In this double-blind randomized-controlled trial, 143 patients undergoing thoracoscopic lung resection surgery were randomly assigned to the dexmedetomidine-sevoflurane (DEX-Sevo, n = 73) or sevoflurane (Sevo, n = 70) groups. Dexmedetomidine or saline administration was started after inducing anesthesia and continued until the end of surgery at a fixed dose (0.5 µg·kg -1 ·hr -1 ). The primary endpoint was the incidence of delirium up until the end of postoperative day 3. Emergence agitation and postoperative delirium were measured with the Riker sedation agitation scale and the confusion assessment method, respectively. The secondary endpoints were serum cytokine and catecholamine levels.
RESULTS


The DEX-Sevo group showed less frequent emergence agitation than the Sevo group (13% vs 35%, respectively; relative risk, 0.38; 95% confidence interval [CI], 0.18 to 0.79; P = 0.011) but the incidence of delirium after discharge from the postanesthesia care unit was not different (25% vs 25%, DEX-Sevo vs Sevo). Both pro- and anti-inflammatory cytokines were lower in the DEX-Sevo group than in the Sevo group. Nevertheless, the interleukin (IL)6/IL10 ratio (median difference, 5.8; 95% CI,1.8 to 10.0; P = 0.012) and IL8/IL10 ratio (median difference, 0.8; 95% CI, 0.2 to 1.3; P = 0.007) were higher in the DEX-Sevo group than in the Sevo group, indicating a pro-inflammatory cytokine balance in the DEX-Sevo group. Norepinephrine and epinephrine levels were lower in the DEX-Sevo group than in the Sevo group (both, P < 0.001).
CONCLUSIONS


Intraoperative dexmedetomidine reduced emergence agitation but not postoperative delirium in patients undergoing thoracic surgery. Dexmedetomidine seemed to affect emergence agitation through catecholamines, but not through an anti-inflammatory action. Trial registration Clinical Research Information Service (KCT 0001877); registered 7 April, 2016.",2019,Both pro- and anti-inflammatory cytokines were lower in the DEX-Sevo group than in the Sevo group.,"['143 patients undergoing thoracoscopic lung resection surgery', 'patients undergoing thoracic surgery', 'thoracic surgery']","['dexmedetomidine', 'Dexmedetomidine or saline', 'Dexmedetomidine', 'dexmedetomidine-sevoflurane (DEX-Sevo, n = 73) or sevoflurane']","['emergence agitation', 'interleukin (IL)6/IL10 ratio', 'incidence of delirium up until the end of postoperative day 3', 'pro-inflammatory cytokine balance', 'IL8/IL10 ratio', 'Norepinephrine and epinephrine levels', 'frequent emergence agitation', 'Riker sedation agitation scale', 'Emergence agitation and postoperative delirium', 'serum cytokine and catecholamine levels']","[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0201998', 'cui_str': 'Adrenaline measurement'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0222045'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0546632', 'cui_str': 'Catecholamine measurement (procedure)'}]",143.0,0.644234,Both pro- and anti-inflammatory cytokines were lower in the DEX-Sevo group than in the Sevo group.,"[{'ForeName': 'Jie Ae', 'Initials': 'JA', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Gangnam-Gu, Seoul, 135-710, South Korea.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Gangnam-Gu, Seoul, 135-710, South Korea. hyunjooahn@skku.edu.'}, {'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Gangnam-Gu, Seoul, 135-710, South Korea.'}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Gangnam-Gu, Seoul, 135-710, South Korea.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Gangnam-Gu, Seoul, 135-710, South Korea.'}, {'ForeName': 'Bong Gyu', 'Initials': 'BG', 'LastName': 'Seong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Gangnam-Gu, Seoul, 135-710, South Korea.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01299-7']
684,30847805,Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee.,"Triamcinolone acetonide extended-release (ER) 32 mg (Zilretta ® ) is approved in the USA for the management of osteoarthritis (OA) pain of the knee and is administered as a single, 5 mL intra-articular (IA) injection. Although the therapeutic effects from IA corticosteroids are typically short-lived, triamcinolone acetonide ER is formulated in poly (lactic-co-glycolic acid) (PLGA) microspheres that slowly release triamcinolone acetonide in the synovium, enabling their prolonged presence in the joint. This reduces systemic exposure and lessens corticosteroid-related systemic adverse reactions, such as blood glucose elevations. In a 24-week, randomized, phase III clinical trial, triamcinolone acetonide ER 32 mg significantly improved mean average daily pain intensity in patients with knee OA relative to placebo, and pain, stiffness and physical function (according to WOMAC criteria) relative to placebo and triamcinolone acetonide crystalline suspension (CS). Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo. Findings from a single-arm phase IIIb study indicated that a repeat administration of triamcinolone acetonide ER may be similarly efficacious to an initial injection without having deleterious effects on cartilage or other aspects of joint structure. Thus, triamcinolone acetonide ER expands the treatment options available for the management of OA pain of the knee.",2019,"Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo.",['patients with knee OA relative to'],"['triamcinolone acetonide', 'placebo', 'Triamcinolone Acetonide Extended-Release', '32\xa0mg (Zilretta ® ', 'Triamcinolone acetonide', 'placebo and triamcinolone acetonide crystalline suspension (CS', 'Triamcinolone acetonide ER', 'triamcinolone acetonide ER']","['release (ER', 'blood glucose elevations', 'mean average daily pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4529671', 'cui_str': 'Zilretta'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.060841,"Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Paik', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': 'Duggan', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Keam', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.'}]",Drugs,['10.1007/s40265-019-01083-3']
685,30838896,"Pseudotumours, cobalt and clinical outcome in small head metal-on-metal versus conventional metal-on-polyethylene total hip arthroplasty.","BACKGROUND


Metal-on-metal total hip arthroplasty (MoM THA) is associated with the formation of pseudotumours. Studies mainly concern pseudotumour formation in large head MoM THA. We performed a long-term follow-up study, comparing pseudotumour incidence in small head metal-on-metal (SHMoM) THA with conventional metal-on-polyethylene (MoP) THA. Predisposing factors to pseudotumour formation were assessed.
METHODS


From a previous randomised controlled trial comparing SHMoM (28 mm) cemented THA with conventional MoP cemented THA, patients were screened using a standardised CT protocol for the presence of pseudotumours. Serum cobalt levels and functional outcome were assessed.
RESULTS


56 patients (33 MoP and 23 MoM) were recruited after mean follow-up of 13.4 years (SD 0.5). The incidence of pseudotumours was 1 (5%) in the SHMoM THA cohort and 3 (9%) in the MoP THA cohort. Prosthesis survival was 96% for both SHMoM and MoP THAs. Serum cobalt levels did not exceed acceptable clinical values (<5 µg/L) whereas no differences in cobalt levels were detected at follow-up between both groups. Oxford and Harris Hip Scores were good and did not differ between SHMoM and MoP THA.
CONCLUSIONS


This long-term follow-up study shows a low incidence of pseudotumour formation and good functional outcome in cemented head-taper matched SHMoM and MoP THA.",2020,This long-term follow-up study shows a low incidence of pseudotumour formation and good functional outcome in cemented head-taper matched SHMoM and MoP THA.,['\n\n\n56 patients (33 MoP and 23 MoM'],"['THA with conventional MoP cemented THA', 'SHMoM', 'cemented head-taper matched SHMoM and MoP THA', 'conventional metal-on-polyethylene total hip arthroplasty', 'small head metal-on-metal (SHMoM) THA with conventional metal-on-polyethylene (MoP']","['cobalt levels', 'Serum cobalt levels and functional outcome', 'Serum cobalt levels', 'Oxford and Harris Hip Scores', 'Prosthesis survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0066823', 'cui_str': 'morpholinopropane sulfonic acid'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}]","[{'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0066823', 'cui_str': 'morpholinopropane sulfonic acid'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0424688', 'cui_str': 'Small head (finding)'}]","[{'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C3179277', 'cui_str': 'Prosthesis Survival'}]",,0.0378228,This long-term follow-up study shows a low incidence of pseudotumour formation and good functional outcome in cemented head-taper matched SHMoM and MoP THA.,"[{'ForeName': 'Hugo C', 'Initials': 'HC', 'LastName': 'van der Veen', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Centre Groningen, University of Groningen, The Netherlands.'}, {'ForeName': 'Inge Hf', 'Initials': 'IH', 'LastName': 'Reininga', 'Affiliation': 'Department of Traumasurgery, University of Groningen, University Medical Centre Groningen, The Netherlands.'}, {'ForeName': 'Wierd P', 'Initials': 'WP', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Centre Leeuwarden, The Netherlands.'}, {'ForeName': 'Martijn F', 'Initials': 'MF', 'LastName': 'Boomsma', 'Affiliation': 'Department of Radiology, Isala Hospital, The Netherlands.'}, {'ForeName': 'Sjoerd K', 'Initials': 'SK', 'LastName': 'Bulstra', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Centre Groningen, University of Groningen, The Netherlands.'}, {'ForeName': 'Jos Jam', 'Initials': 'JJ', 'LastName': 'van Raay', 'Affiliation': 'Department of Orthopaedic Surgery, Martini Hospital Groningen, The Netherlands.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019832877']
686,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
687,30829190,Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial.,"BACKGROUND


Befriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.
AIMS


To conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.
METHOD


Patients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.
RESULTS


A total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI -40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.
CONCLUSIONS


Although no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.",2020,"At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI -40.7 to 58.5, P = 0.72).","['124 patients', 'Patients', 'patients with schizophrenia or related disorders', 'patients with schizophrenia']","['volunteer befriending programme', 'befriending programme for 1 year or to receive information about social activities']","['daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis', 'quality of life, symptoms or self-esteem', 'social contacts', 'mean TUS scores']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",124.0,0.181147,"At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI -40.7 to 58.5, P = 0.72).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Professor, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development), Queen Mary University of London, UK.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Chevalier', 'Affiliation': 'Trial Manager, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development), Queen Mary University of London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamborg', 'Affiliation': 'Statistician, Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Queen Mary University of London, UK.'}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Golden', 'Affiliation': 'Volunteer Coordinator, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development), Queen Mary University of London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Professor, Division of Psychiatry, Faculty of Brain Sciences, University College London, UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Pistrang', 'Affiliation': 'Emeritus Professor, Department of Clinical, Educational and Health Psychology, University College London, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.42']
688,31704126,The effects of early pacifier use on breastfeeding: A randomised controlled trial.,"BACKGROUND


The majority of observational studies have found associations between pacifier use and shorter breastfeeding duration. Results from four randomised controlled trials did not reveal any difference in breastfeeding outcomes. The relationship between early pacifier use and breastfeeding outcomes remains unclear.
AIM


To investigate whether a recommendation of early pacifier use affects the proportion of breastfeeding at six months compared to a recommendation to avoid pacifier use during the first two weeks.
METHODS


An open, randomised controlled trial with parallel group design; 239 primiparous mothers and their term infants were randomly assigned to an intervention group or a control group. The primary outcome was the proportion of breastfeeding at six months. Secondary outcomes were the proportions of breastfeeding and breastfeeding problems at two and four months. To investigate factors which may influence breastfeeding, a multivariate logistic regressions analysis was performed.
FINDINGS


A total of 209 participants (87.5%) completed the study. There were no significant differences between the groups with respect to breastfeeding at six months. No negative association for breastfeeding between early versus late introduction of pacifier was found. Factors significantly associated with cessation of breastfeeding at six months were: use of nipple shield, intention to breastfeed, severe breastfeeding problems at two weeks, pacifier use at two months and lower educational level.
CONCLUSION


Early versus late recommendation of pacifier introduction did not affect the proportion of breastfeeding at six months. However, the compliance to the randomised group was insufficient. No negative association was found in the observational analysis.",2020,There were no significant differences between the groups with respect to breastfeeding at six months.,"['A total of 209 participants (87.5%) completed the study', '239 primiparous mothers and their term infants']",[],"['proportions of breastfeeding and breastfeeding problems', 'proportion of breastfeeding at six months', 'nipple shield, intention to breastfeed, severe breastfeeding problems', 'breastfeeding outcomes', 'breastfeeding', 'proportion of breastfeeding']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]",[],"[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0183252', 'cui_str': 'Nipple shield (physical object)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",209.0,0.117795,There were no significant differences between the groups with respect to breastfeeding at six months.,"[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Hermanson', 'Affiliation': 'Department of Obstetrics, and Gynaecology, University Hospital, Linköping, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden. Electronic address: asa.hermansson@regionostergotland.se.'}, {'ForeName': 'Lotta Lindh', 'Initials': 'LL', 'LastName': 'Åstrand', 'Affiliation': 'Department of Obstetrics, and Gynaecology, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2019.10.001']
689,29525328,Is Time of the Essence? The Impact of Time of Hospital Presentation in Acute Heart Failure: Insights From ASCEND-HF Trial.,"OBJECTIVES


As the largest acute heart failure (AHF) trial conducted to date, the global ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial database presented an opportunity to systematically describe the relationship among time of hospital presentation, clinical profile, inpatient management, and outcomes among patients admitted with AHF.
BACKGROUND


Time of hospital presentation has been shown to impact outcomes among patients hospitalized with many conditions. However, the association among time of presentation and patient characteristics, management, and clinical outcomes among patients hospitalized with AHF has not been well characterized.
METHODS


A post hoc analysis of the ASCEND-HF trial was performed, which enrolled 7,141 patients hospitalized for AHF. Patients were divided based on when they presented to the hospital; regular hours were defined as 9 am to 5 pm, Monday through Friday, and off hours were defined as 5 pm to 9 am, Monday through Friday and weekends. Clinical characteristics and outcomes were compared by time of presentation.
RESULTS


Overall, 3,298 patients (46%) presented during off hours. Off-hour patients were more likely to have orthopnea (80% vs. 74%, respectively) and rales (56% vs. 49%, respectively) than regular-hour patients. Off-hour patients were more likely to receive intravenous (IV) nitroglycerin (18% vs. 11%, respectively) and IV loop diuretics (92% vs. 86%, respectively) as initial therapy and reported greater relief from dyspnea at 24 h (odds ratio [OR]: 1.14; 95% confidence interval [CI]: 1.04 to 1.24; p = 0.01) than regular-hour patients. After adjustment, off-hour presentation was associated with significantly lower 30-day mortality (OR: 0.74; 95% CI: 0.57 to 0.96; p = 0.03) and 180-day mortality (hazard ratio [HR]: 0.82; 95% CI: 0.72 to 0.94; p = 0.01) but similar 30-day rehospitalization rates (p = 0.40).
CONCLUSIONS


In this AHF trial, patients admitted during off hours exhibited a distinct clinical profile, experienced greater dyspnea relief, and had lower post-discharge mortality than regular-hour patients. These findings have implications for future AHF trials.",2018,"Off-hour patients were more likely to have orthopnea (80% vs. 74%, respectively) and rales (56% vs. 49%, respectively) than regular-hour patients.","['Acute\xa0Heart Failure', 'patients admitted with AHF', '7,141 patients hospitalized for AHF', 'patients hospitalized with many conditions', '3,298 patients (46%) presented during off hours', 'patients hospitalized with AHF']",['intravenous (IV) nitroglycerin'],"['post-discharge mortality', 'orthopnea', '30-day mortality', 'dyspnea relief', '180-day mortality', '30-day rehospitalization rates', 'relief from dyspnea']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085619', 'cui_str': 'Orthopnea (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}]",7141.0,0.164416,"Off-hour patients were more likely to have orthopnea (80% vs. 74%, respectively) and rales (56% vs. 49%, respectively) than regular-hour patients.","[{'ForeName': 'Lukasz P', 'Initials': 'LP', 'LastName': 'Cerbin', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, Durham, North Carolina. Electronic address: lukasz.p.cerbin@duke.edu.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, North Carolina, Durham, North Carolina.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, North Carolina, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Division of Cardiology, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Duke Clinical Research Institute, North Carolina, Durham, North Carolina.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, North Carolina, Durham, North Carolina.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, North Carolina, Durham, North Carolina.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veteran Affairs Medical Center, and School of Medicine, University of California-San Francisco, San Francisco, California.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Duke Clinical Research Institute, North Carolina, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, North Carolina, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2018.01.018']
690,30729881,Outcomes of a Problem-Solving Medication Management Intervention for Informal Caregivers.,"Older adults with memory loss often require assistance from caregivers to manage their medications. This study examined the efficacy of a problem-solving-based intervention focused on caregiver medication management, problem solving, self-efficacy, and daily hassles. Caregiver health-related quality of life (HRQoL) and patient health care utilization were secondary outcomes. Totally, 83 patients (age 79.9±8.8 years) and their informal caregivers (age 66.9±12 years, female 69.9%, White 85.5%) were randomized; data collection occurred at baseline, 8, 16, and 24 weeks. Linear mixed modeling showed significant decreases in medication deficiencies which were sustained over time. No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time. In addition, caregiver self-efficacy and mental HRQoL decreased in both groups. Physical HRQoL decreased in the intervention group, yet increased in the usual care group. Future research should investigate these outcomes in larger and more diverse samples.",2019,"No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time.","['Older adults with memory loss', 'Informal Caregivers', '83 patients (age 79.9±8.8 years) and their informal caregivers (age 66.9±12 years, female 69.9%, White 85.5']","['problem-solving-based intervention', 'Problem-Solving Medication Management Intervention']","['Physical HRQoL', 'caregiver problem solving, daily hassles, or patient health care utilization', 'caregiver self-efficacy and mental HRQoL', 'medication deficiencies', 'Caregiver health-related quality of life (HRQoL) and patient health care utilization']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751295', 'cui_str': 'Memory Loss'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",83.0,0.037252,"No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time.","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Erlen', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Tamres', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Fengyan', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lingler', 'Affiliation': 'University of Pittsburgh, PA, USA.'}]",Western journal of nursing research,['10.1177/0193945919825844']
691,30824430,Effect of creative writing on mood in patients with cancer.,"OBJECTIVE


To determine the feasibility of conducting creative writing workshops (CWW) for patients with cancer to promote improvement in mood.
METHOD


We piloted a prospective study to determine the feasibility of conducting CWW over a 4-week period. Patients were randomised 2:1 to either an intervention arm (IA) or to standard of care (SOC). Patients in the IA attended four 2-hour long weekly CWW × 4 weeks, whereas those receiving SOC did not participate in the CWW. We used a validated emotion thermometer scale (ETS) to assess changes in patient's mental health before and after intervention. Patients with metastatic or unresectable cancer were included. PRIMARY ENDPOINT: (1) Feasibility and (2) mood scores before and after CWW using ETS.
RESULTS


A total of 16 patients were enrolled: 11 in the IA vs 5 in SOC. Seven out of 11 (63%) patients enrolled in the IA attended at least 75% of classes. Patients in the IA showed a trend towards mood improvement relative to the SOC when comparing initial and final ETS scores. Within the IA group significantly lower postclass total ETS scores were observed relative to preclass ETS scores. Also, a significant decreasing trend over time was observed in the preclass total ETS scores for participants in the IA group.
CONCLUSIONS


It is feasible for patients with cancer to attend CWW. Our results also show a positive effect on mood in the CWW arm. Further prospective clinical studies are needed to evaluate the effect of this intervention in patients with cancer.",2020,"Also, a significant decreasing trend over time was observed in the preclass total ETS scores for participants in the IA group.
","['patients with cancer to attend CWW', 'Patients with metastatic or unresectable cancer', 'patients with cancer to promote improvement in mood', '16 patients were enrolled: 11 in the IA vs 5 in SOC', 'patients with cancer']","['intervention arm (IA) or to standard of care (SOC', 'creative writing workshops (CWW', 'creative writing']","['preclass total ETS scores', 'postclass total ETS scores', 'Feasibility and (2) mood scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",16.0,0.0263475,"Also, a significant decreasing trend over time was observed in the preclass total ETS scores for participants in the IA group.
","[{'ForeName': 'Junjia', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Public Health Sciences, Penn State Cancer Institute, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Medicine, Penn State Cancer Institute, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry, Penn State, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Cristina I', 'Initials': 'CI', 'LastName': 'Truica', 'Affiliation': 'Medicine, Penn State Cancer Institute, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Darya', 'Initials': 'D', 'LastName': 'Nesterova', 'Affiliation': 'Neurosurgery, Penn State College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': 'Medicine, Penn State Cancer Institute, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Erika F H', 'Initials': 'EFH', 'LastName': 'Saunders', 'Affiliation': 'Department of Psychiatry, Penn State, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Medicine, Penn State Cancer Institute, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Drabick', 'Affiliation': 'Medicine, Penn State Cancer Institute, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Medicine, Penn State Cancer Institute, Hershey, Pennsylvania, USA mjoshi@pennstatehealth.psu.edu.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2018-001710']
692,30811082,The effect of acute exercise on the performance of verbal fluency in adolescents and young adults with Down syndrome: a pilot study.,"BACKGROUND


The high prevalence of cognitive dysfunction is well documented in individuals with Down syndrome. However, only a few studies have focused on the effect of exercise on cognitive performance in this population. In particular, verbal fluency has been shown to be relevant to the early onset of Alzheimer's disease in individuals with Down syndrome. Thus, this study was aimed at investigating the relationship between acute exercise and verbal fluency in this population.
METHODS


It was a pre-post design. Twenty-eight participants (aged 14-31) were assigned to high-intensity exercise (i.e. 70-85% of predicted maximum heart rate) (N = 8), moderate-intensity exercise (i.e. 50-69% of predicted maximum heart rate) (N = 10) or attentional control (N = 10) groups. Two exercise groups walked on a treadmill using an incremental walking protocol, and the attentional control group watched a video for 20 min. Measures of verbal fluency (i.e. semantic fluency and phonetic fluency) were tested pre-intervention and post-intervention.
RESULTS


The result showed a quadric trend between semantic fluency and intensity of exercise. The improvement in cognitive performance on semantic fluency test was observed in the moderate-intensity exercise. However, neither a linear trend nor a quadric trend was seen in phonetic fluency.
CONCLUSIONS


The result showed an inverted-U relationship between exercise intensity and semantic fluency. A larger sample size, testing time and more reliable psychophysiological measures (e.g. VO 2  max and neuroimaging technology), should be considered to explore the underlying mechanisms in this population.",2019,The improvement in cognitive performance on semantic fluency test was observed in the moderate-intensity exercise.,"['adolescents and young adults with Down syndrome', 'individuals with Down syndrome', 'Twenty-eight participants (aged 14-31']","['Two exercise groups walked on a treadmill using an incremental walking protocol, and the attentional control group watched a video for 20\xa0min', 'attentional control', 'acute exercise', 'high-intensity exercise']","['verbal fluency', 'cognitive performance on semantic fluency test', 'phonetic fluency', 'verbal fluency (i.e. semantic fluency and phonetic fluency', 'semantic fluency and intensity of exercise', 'cognitive performance', 'moderate-intensity exercise']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]",28.0,0.0825524,The improvement in cognitive performance on semantic fluency test was observed in the moderate-intensity exercise.,"[{'ForeName': 'C-C J J', 'Initials': 'CJJ', 'LastName': 'Chen', 'Affiliation': 'Department of Kinesiology, Mississippi State University, Mississippi State, MS, USA.'}, {'ForeName': 'S D R', 'Initials': 'SDR', 'LastName': 'Ringenbach', 'Affiliation': 'School of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12603']
693,30561740,Outcomes of a 6-week Cognitive-Behavioral Therapy for Chronic Pain Group for veterans seen in primary care.,"Primary Care Mental Health Integration (PC-MHI) visits are mandated to be brief, limited in number, and delivered in the primary care practice area. Current evidence-based protocols for Cognitive-Behavioral Therapy for Chronic Pain (CBT-CP) do not meet these PC-MHI requirements, however, and thus PC-MHI providers are often left with the daunting task of modifying these protocols for the primary care setting. The aims of the current study were to examine effectiveness for a brief CBT-CP Group (6, 50-min sessions) for patients seen in primary care with various chronic pain conditions and to assess whether opioid medication use was associated with treatment outcomes. The current study represents a single-arm treatment study in which outcomes were evaluated by comparing self-reported symptom levels at the beginning of treatment (Session 1) to the end of treatment (Session 6). Dependent variables included pain symptoms, physical function lower/upper body, family disability, emotional functioning, sleep problems, satisfactions with outcomes/care, pain-related anxiety, generalized anxiety, pain catastrophizing, and depressed mood. Seventy-seven participants were enrolled and completed the treatment group. They were 56.81 ± 13.11 years old, 61% male, 51.9% taking opioids, with 39% reporting multiple pain diagnoses. Results showed that participation in the Brief CBT-CP Group resulted in statistically significantly improvement across all dependent variables (except emotional functioning). Results also showed that there were no significant treatment-related differences between patients taking opioids compared with patients who were not on opioids. The current protocol for Brief CBT-CP is effective in a real-world setting and aligns with the PC-MHI model of care.",2020,Results showed that participation in the Brief CBT-CP Group resulted in statistically significantly improvement across all dependent variables (except emotional functioning).,"['They were 56.81 ± 13.11 years old, 61% male, 51.9% taking opioids, with 39% reporting multiple pain diagnoses', 'Chronic Pain Group for veterans seen in primary care', 'Seventy-seven participants were enrolled and completed the treatment group', 'patients seen in primary care with various chronic pain conditions']","['CBT-CP', '6-week Cognitive-Behavioral Therapy']","['pain symptoms, physical function lower/upper body, family disability, emotional functioning, sleep problems, satisfactions with outcomes/care, pain-related anxiety, generalized anxiety, pain catastrophizing, and depressed mood']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}]",77.0,0.0286432,Results showed that participation in the Brief CBT-CP Group resulted in statistically significantly improvement across all dependent variables (except emotional functioning).,"[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Martinson', 'Affiliation': 'VA Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craner', 'Affiliation': 'The Pain Center, Mary Free Bed Rehabilitation Hospital, Suite, Grand Rapids, MI, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Clinton-Lont', 'Affiliation': 'VA Salt Lake City Health Care System, Salt Lake City, UT, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby127']
694,31701699,"γ-Linolenic Acid versus α-Lipoic Acid for Treating Painful Diabetic Neuropathy in Adults: A 12-Week, Double-Placebo, Randomized, Noninferiority Trial.","BACKGROUND


This study was a multicenter, parallel-group, double-blind, double-dummy, randomized, noninferiority trial to evaluate the efficacy and safety of γ-linolenic acid (GLA) relative to α-lipoic acid (ALA) over a 12-week treatment period in type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN).
METHODS


This study included 100 T2DM patients between 20 and 75 years of age who had painful DPN and received either GLA (320 mg/day) and placebo or ALA (600 mg/day) and placebo for 12 weeks. The primary outcome measures were mean changes in pain intensities as measured by the visual analogue scale (VAS) and the total symptom scores (TSS).
RESULTS


Of the 100 subjects who initially participated in the study, 73 completed the 12-week treatment period. Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups. The treatment difference for the VAS (95% confidence interval [CI]) between the two groups was -0.65 (-1.526 to 0.213) and the upper bound of the 95% CI did not exceed the predefined noninferiority margin (δ₁=0.51). For the TSS, the treatment difference was -0.05 (-1.211 to 1.101) but the upper bound of the 95% CI crossed the noninferiority margin (δ₂=0.054). There were no serious adverse events associated with the treatments.
CONCLUSION


GLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing pain intensity measured by the VAS over 12 weeks.",2020,"Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups.","['type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN', 'Adults', '100 T2DM patients between 20 and 75 years of age who had painful DPN and received either', '100 subjects who initially participated in the study', 'patients with painful DPN']","['placebo or ALA', 'γ-Linolenic Acid versus α-Lipoic Acid', 'placebo', 'Double-Placebo', 'γ-linolenic acid (GLA) relative to α-lipoic acid (ALA', 'GLA']","['mean changes in pain intensities as measured by the visual analogue scale (VAS) and the total symptom scores (TSS', 'pain intensity', 'mean VAS and TSS scores', 'VAS', 'serious adverse events']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",73.0,0.297576,"Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups.","[{'ForeName': 'Jong Chul', 'Initials': 'JC', 'LastName': 'Won', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyuk Sang', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Seong Su', 'Initials': 'SS', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Chong Hwa', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Sejong General Hospital, Bucheon, Korea.'}, {'ForeName': 'Ie Byung', 'Initials': 'IB', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicien, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'In Joo', 'Initials': 'IJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Bong Yun', 'Initials': 'BY', 'LastName': 'Cha', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Tae Sun', 'Initials': 'TS', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea. pts@jbnu.ac.kr.'}]",Diabetes & metabolism journal,['10.4093/dmj.2019.0099']
695,31693429,Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.,"PURPOSE


Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) fare poorly, with limited treatment options. The antibody-drug conjugate polatuzumab vedotin targets CD79b, a B-cell receptor component.
METHODS


Safety and efficacy of polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG) was evaluated in a single-arm cohort. Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR) was compared with bendamustine and rituximab (BR) in a randomly assigned cohort of patients with transplantation-ineligible R/R DLBCL (primary end point: independent review committee [IRC] assessed complete response [CR] rate at the end of treatment). Duration of response, progression-free survival (PFS), and overall survival (OS) were analyzed using Kaplan-Meier and Cox regression methods.
RESULTS


Pola-BG and pola-BR had a tolerable safety profile. The phase Ib/II pola-BG cohort (n = 27) had a CR rate of 29.6% and a median OS of 10.8 months (median follow-up, 27.0 months). In the randomly assigned cohort (n = 80; 40 per arm), pola-BR patients had a significantly higher IRC-assessed CR rate (40.0%  v  17.5%;  P  = .026) and longer IRC-assessed PFS (median, 9.5  v  3.7 months; hazard ratio [HR], 0.36, 95% CI, 0.21 to 0.63;  P  < .001) and OS (median, 12.4  v  4.7 months; HR, 0.42; 95% CI, 0.24 to 0.75;  P  = .002; median follow-up, 22.3 months). Pola-BR patients had higher rates of grade 3-4 neutropenia (46.2%  v  33.3%), anemia (28.2%  v  17.9%), and thrombocytopenia (41%  v  23.1%), but similar grade 3-4 infections (23.1%  v  20.5%), versus the BR group. Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients.
CONCLUSION


Polatuzumab vedotin combined with BR resulted in a significantly higher CR rate and reduced the risk of death by 58% compared with BR in patients with transplantation-ineligible R/R DLBCL.",2020,"Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients.
","['patients with transplantation-ineligible R/R DLBCL (primary end point', 'Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL']","['polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG', 'Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR', 'bendamustine and rituximab (BR']","['risk of death', 'complete response [CR] rate', 'rates of grade 3-4 neutropenia', 'longer IRC-assessed PFS', 'anemia', 'CR rate', 'Duration of response, progression-free survival (PFS), and overall survival (OS', 'tolerable safety profile', 'IRC-assessed CR rate', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4078806', 'cui_str': 'polatuzumab vedotin'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",,0.250087,"Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients.
","[{'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alex F', 'Initials': 'AF', 'LastName': 'Herrera', 'Affiliation': 'City of Hope, Duarte, CA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Manali K', 'Initials': 'MK', 'LastName': 'Kamdar', 'Affiliation': 'University of Colorado, Aurora, CO.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': 'Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hertzberg', 'Affiliation': 'Prince of Wales Hospital and University of NSW, Sydney, NSW, Australia.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Assouline', 'Affiliation': 'Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Elicia', 'Initials': 'E', 'LastName': 'Penuel', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Paulson', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'F. Hoffman-La Roche, Mississauga, Ontario, Canada.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ku', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00172']
696,30702758,Internet-based treatment of depressive symptoms in a Kurdish population: A randomized controlled trial.,"OBJECTIVE


Kurdish immigrants in Sweden have a doubled risk of mental health problems, and refugee and immigrant populations underutilize mental health services. The present study investigated the efficacy of culturally adapted guided internet-based cognitive behavior therapy (ICBT) for depressive symptoms in a Kurdish population.
METHOD


We included 50 individuals who were randomized to either an 8-week treatment or a wait-list. The Beck Depression Inventory-II was the primary outcome measure, and measures of anxiety and insomnia were secondary outcomes.
RESULTS


Depressive symptoms were significantly reduced (intention-to-treat analysis) in the treatment group, with a between-group effect size at posttreatment of Cohen's d = 1.27. Moderate to large between-group effects were also observed on all secondary outcome measures. Treatment effects were sustained at 11-month follow-up.
CONCLUSION


The results provide preliminary support for culturally adapted ICBT as a complement to other treatment formats for treating symptoms of depression in a Kurdish population.",2019,"Depressive symptoms were significantly reduced (intention-to-treat analysis) in the treatment group, with a between-group effect size at posttreatment of Cohen's d = 1.27.","['depressive symptoms in a Kurdish population', 'Kurdish immigrants in Sweden have a doubled risk of mental health problems, and refugee and immigrant populations underutilize mental health services', '50 individuals']",['culturally adapted guided internet-based cognitive behavior therapy (ICBT'],"['anxiety and insomnia', 'Depressive symptoms']","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",50.0,0.19114,"Depressive symptoms were significantly reduced (intention-to-treat analysis) in the treatment group, with a between-group effect size at posttreatment of Cohen's d = 1.27.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Nygren', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brohede', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kocher', 'Initials': 'K', 'LastName': 'Koshnaw', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Shevan Sherzad', 'Initials': 'SS', 'LastName': 'Osman', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Journal of clinical psychology,['10.1002/jclp.22753']
697,32407947,"Intralymphatic immunotherapy for mountain cedar pollinosis: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Allergen immunotherapy can provide long-term benefits, including symptomatic relief and reduced disease progression, but it requires a lengthy regimen that presents barriers to patient adherence. Thus, there is a need for improved approaches to immunotherapy. Recently, several clinical trials have reported successful results from intralymphatic immunotherapy.
OBJECTIVE


To evaluate the efficacy, safety, and tolerability of intralymphatic immunotherapy for allergies caused by mountain cedar pollen in a proof-of-concept study.
METHODS


A total of 21 patients with allergic rhinoconjunctivitis because of mountain cedar pollen were randomized to receive 3 monthly intralymphatic injections of allergenic extract or placebo before the 2018-2019 mountain cedar pollen season. Safety was monitored during treatment to the end of the pollen season using structured and spontaneous reports. Clinical efficacy information was collected using a daily electronic diary of symptoms and allergy medication. Allergen-specific serum immunoglobulin E was assessed before treatment and at the end of the study.
RESULTS


There were no serious adverse events or systemic reactions in either group. A total of 4 patients experienced mild injection-site reactions. Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (P < .001), and the active treatment group had lower average total combined scores on 20 of 27 days during the peak pollen season (P < .05). There was no significant difference among groups in changes to mean mountain cedar-specific serum immunoglobulin E levels.
CONCLUSION


In this proof-of-concept trial, intralymphatic immunotherapy was well tolerated and improved the symptoms and medication use associated with allergic rhinoconjunctivitis caused by mountain cedar pollen.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov under the registration number NCT03682965 before the enrollment of the first subject.",2020,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"['mountain cedar pollinosis', 'prior to the 2018-2019 mountain cedar pollen season', 'Twenty-one patients with allergic rhinoconjunctivitis due to mountain cedar pollen']","['allergenic extract or placebo', 'intralymphatic immunotherapy', 'Intralymphatic immunotherapy', 'placebo']","['Safety', 'allergy symptoms and medication use relative', 'serious adverse events or systemic reactions', 'efficacy, safety and tolerability', 'mild injection-site reactions', 'mean mountain cedar-specific serum IgE levels', 'average total combined scores']","[{'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0440386', 'cui_str': 'Mountain cedar pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0440016', 'cui_str': 'Allergenic extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",21.0,0.239599,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Thompson', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Silvers', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Mark Adam', 'Initials': 'MA', 'LastName': 'Shapiro', 'Affiliation': 'Pharma Initiatives Consulting, Chapel Hill, North Carolina. Electronic address: mshapiro@pharmainitiatives.com.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.030']
698,31657038,The effect of solution-focused interviews (SFI) conducted by nurses on middle school adolescents' healthy lifestyles: a quasi-experimental study.,"AIM


This study aimed at assessing the effect of solution-focused interviews for the promotion of health locus of control and self-efficacy on adolescents' healthy lifestyles.
METHOD


The present study, which was designed as a quasi-experimental study, included pretest and post-test control groups and was conducted in the period between 5 February 2017 and 30 April 2017. The intervention group comprised 28 (n = 28) adolescents from a school, and the control group comprised 30 (n = 30) adolescents from another school. Solution-focused interviews, which included educational information regarding leading a healthy lifestyle as well as cognitive-behavioural interview, were conducted with the adolescents of the intervention group, 1 day per week (nine sessions in total).
RESULTS


In comparison to the control group, adolescents in the intervention group exhibited differences in all the sub-dimensions health promotion scale (p < 0.001).
CONCLUSIONS


These results established the applicability and effectiveness of the programme, such that the health promotion programme could be included in the literature. Moreover, it is anticipated that this programme would be applied in school settings in the future.",2020,"In comparison to the control group, adolescents in the intervention group exhibited differences in all the sub-dimensions health promotion scale (p < 0.001).
","[""middle school adolescents' healthy lifestyles"", 'period between 5 February 2017 and 30 April 2017', ""adolescents' healthy lifestyles"", '28 (n\xa0=\xa028) adolescents from a school, and the control group comprised 30 (n\xa0=\xa030) adolescents from another school']",['solution-focused interviews (SFI'],['sub-dimensions health promotion scale'],"[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0222045'}]",,0.0200685,"In comparison to the control group, adolescents in the intervention group exhibited differences in all the sub-dimensions health promotion scale (p < 0.001).
","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Aslan', 'Affiliation': 'Health Sciences Faculty, Nursing Department, Çankırı Karatekin University, Çankırı, Türkiye.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12776']
699,30499599,The role of pathogen-reduced platelet transfusions on HLA alloimmunization in hemato-oncological patients.,"BACKGROUND


Platelet transfusions can induce alloimmunization against HLA antigens. The use of pathogen-reduced platelet concentrates (PCs) was suggested to reduce HLA alloimmunization and concomitant transfusion refractoriness.
METHODS


This study investigated HLA alloimmunization in available samples from 448 hemato-oncological patients who were randomized for the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial to receive either untreated or pathogen-reduced PCs (Mirasol, Terumo BCT Inc.). Anti-HLA Class I and II antibodies were determined before the first platelet transfusion and weekly thereafter using multiplex assay with standard cutoffs to detect low- as well as high-level antibodies.
RESULTS


When using the lower cutoff, in patients who were antibody negative at enrollment, 5.4% (n = 12) developed anti-HLA Class I antibodies after receiving untreated PCs, while this was significantly higher in patients receiving pathogen-reduced PCs, 12.8% (n = 29; p = 0.009, intention-to-treat [ITT] analysis). A similar but nonsignificant trend was observed in the per-protocol (PP) analysis (5.4% vs. 10.1%; p = 0.15). HLA class II antibody formation was similar between both types of PCs in the ITT analysis, while the PP analysis showed a trend toward lower immunization after receiving pathogen-reduced PCs. Multivariate analysis identified receiving pathogen-reduced platelets as an independent risk factor for HLA Class I alloimmunization (ITT: odds ratio [95% confidence interval] = 3.02 [1.42-6.51], PP: odds ratio [95% confidence interval] = 2.77 [1.00-5.40]), without affecting HLA Class II alloimmunization. When using the high cutoff value, the difference in HLA Class I alloimmunization between study arms remained significant in the ITT analysis and again was not significant in the PP analysis.
CONCLUSION


Our data clearly indicate that Mirasol pathogen inactivation does not prevent HLA Class I or II alloimmunization after platelet transfusions.",2019,Multivariate analysis identified receiving pathogen-reduced platelets as an independent risk factor for HLA Class I alloimmunization (ITT: odds ratio [95% confidence interval] =,"['448 hemato-oncological patients who were randomized for the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial to receive either', 'hemato-oncological patients']","['untreated or pathogen-reduced PCs (Mirasol, Terumo BCT Inc', 'pathogen-reduced platelet transfusions', 'pathogen-reduced platelet concentrates (PCs']","['HLA alloimmunization', 'anti-HLA Class', 'HLA class II antibody formation', 'HLA Class I alloimmunization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}]","[{'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}]",,0.0379867,Multivariate analysis identified receiving pathogen-reduced platelets as an independent risk factor for HLA Class I alloimmunization (ITT: odds ratio [95% confidence interval] =,"[{'ForeName': 'Anno', 'Initials': 'A', 'LastName': 'Saris', 'Affiliation': 'Department of Immunopathology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Jean Louis', 'Initials': 'JL', 'LastName': 'Kerkhoffs', 'Affiliation': 'Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Norris', 'Affiliation': 'Blood Systems Research Institute, San Francisco, California.'}, {'ForeName': 'S Marieke', 'Initials': 'SM', 'LastName': 'van Ham', 'Affiliation': 'Department of Immunopathology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ten Brinke', 'Affiliation': 'Department of Immunopathology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.'}, {'ForeName': 'Pieter F', 'Initials': 'PF', 'LastName': 'van der Meer', 'Affiliation': 'Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.'}, {'ForeName': 'Jaap Jan', 'Initials': 'JJ', 'LastName': 'Zwaginga', 'Affiliation': 'Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.'}]",Transfusion,['10.1111/trf.15056']
700,31646262,Progesterone-primed ovarian stimulation in polycystic ovarian syndrome: An RCT.,"Background


In vitro fertilization is an important therapy for women with polycystic ovarian syndrome (PCOS). The use of new ways of improving clinical results is yet required.
Objective


This study was aimed to investigate the efficacy of progesterone primed ovarian stimulation (PPOS) and compare with conventional antagonist protocol in PCOS.
Materials and Methods


A total of 120 PCOS women who were candidates for assisted reproductive technology treatment from August to January 2019 were enrolled in this RCT and were placed into two groups, randomly (n= 60/each). The PPOS group received 20 mg /day Dydrogesterone orally since the second day of the cycle and the control group received antagonist protocol. The pregnancy outcomes including the chemical and clinical pregnancy, the miscarriage rate, and the percent of gestational sacs/ transferred embryos was compared in two groups.
Results


Number of MII oocyte, maturity rate, Number of 2 pronuclei (2PN) and serum estradiol levels on trigger day were statistically lower in PPOS group (p = 0.019, p = 0.035, p = 0.032, p = 0.030), respectively. Serum LH level on trigger day in PPOS group was higher than antagonist group (p = 0.005). Although there wasn't sever ovarian hyper simulation syndrome in any participants, mild and moderate ovarian hyper simulation syndrome was less in PPOS group (p = 0.001). Also, the chemical and clinical pregnancy rate were higher in the antagonist group, althoughit was not statistically significant (p = 0.136, p = 0.093 respectively).
Conclusion


Our study demonstrate that PPOS does not improve chemical and clinical pregnancy rate of the infertile women with PCOS.",2019,Serum LH level on trigger day in PPOS group was higher than antagonist group (p = 0.005).,"['women with polycystic ovarian syndrome (PCOS', 'infertile women with PCOS', 'polycystic ovarian syndrome', '120 PCOS women who were candidates for assisted reproductive technology treatment from August to January 2019 were enrolled in this']","['antagonist protocol', 'Progesterone-primed ovarian stimulation', 'progesterone primed ovarian stimulation (PPOS', 'RCT', 'Dydrogesterone', 'PPOS']","[""n't sever ovarian hyper simulation syndrome"", 'mild and moderate ovarian hyper simulation syndrome', 'pregnancy outcomes including the chemical and clinical pregnancy, the miscarriage rate, and the percent of gestational sacs/ transferred embryos', 'chemical and clinical pregnancy rate', 'Number of MII oocyte, maturity rate, Number of 2 pronuclei (2PN) and serum estradiol levels', 'Serum LH level']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technology'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C1304771', 'cui_str': 'Serum LH measurement'}]",2019.0,0.0783814,Serum LH level on trigger day in PPOS group was higher than antagonist group (p = 0.005).,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eftekhar', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd Iran.'}, {'ForeName': 'Masrooreh', 'Initials': 'M', 'LastName': 'Hoseini', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Saeed', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i9.5103']
701,30790446,Index of microvascular resistance to assess the effect of rosuvastatin on microvascular function in women with chest pain and no obstructive coronary artery disease: A double-blind randomized study.,"INTRODUCTION


Many women undergoing coronary angiography for chest pain have no or only minimal coronary artery disease (CAD). However, despite the lack of obstructive CAD, they still have an increased risk of major adverse cardiovascular events. Pleiotropic effects of statins may influence microvascular function, but if statins improve microvascular function in unselected chest pain patients is not well studied. This study assessed microvascular function by using the thermodilution-derived test ""the index of microvascular resistance"" (IMR) with the aim of determining the (i) IMR level in women with chest pain and non-obstructive CAD and if (ii) IMR is modified by high-dose statin treatment in these patients. Additional objectives were to identify the influence of statins on the health status as assessed with generic health questionnaires and on biomarkers of endothelial activation.
MATERIALS AND METHODS


The study was a randomized, double-blind, single-center trial comparing 6 months of rosuvastatin treatment with placebo. In total, 66 women without obstructive CAD were included. Mean age was 52.7 years and 55.5 years in the placebo and rosuvastatin group, respectively. Microvascular function was assessed using the IMR, health status was assessed using the SF-36 and EQ-5D questionnaires, and biochemical values were assessed at baseline and 6 months later.
RESULTS AND CONCLUSIONS


In the placebo group IMR was 14.6 (SD 5.7) at baseline and 14.4 (SD 6.5) at follow-up. In the rosuvastatin group IMR was 16.5 (SD 7.5) at baseline and 14.2 (SD 5.8) at follow-up. IMR did not differ significantly between the two study groups at follow-up controlled for preintervention values. C-reactive protein (CRP) was comparable between the groups at baseline, while at follow-up CRP was significantly lower in the rosuvastatin group compared to placebo [0.6 (±0.5) mg/L vs. 2.6 (±3.0) mg/L; p = 0.002]. Whereas rosuvastatin treatment for 6 months attenuated CRP levels, it did not improve microvascular function as assessed by IMR (Clinical Trials.gov NCT01582165, EUDRACT 2011-002630-39.3tcAZ).",2019,"Whereas rosuvastatin treatment for 6 months attenuated CRP levels, it did not improve microvascular function as assessed by IMR (Clinical Trials.gov NCT 01582165, EUDRACT 2011-002630-39.3tcAZ).","['women with chest pain and non-obstructive CAD and if (ii) IMR', 'Mean age was 52.7 years and 55.5 years in the', 'women with chest pain and no obstructive coronary artery disease', '66 women without obstructive CAD', 'unselected chest pain patients', 'women undergoing coronary angiography for chest pain have no or only minimal coronary artery disease (CAD']","['rosuvastatin', 'placebo', 'placebo and rosuvastatin']","['IMR, health status', 'Microvascular function', 'microvascular function', 'CRP levels', 'SF-36 and EQ-5D questionnaires, and biochemical values', 'C-reactive protein (CRP', 'IMR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",66.0,0.239016,"Whereas rosuvastatin treatment for 6 months attenuated CRP levels, it did not improve microvascular function as assessed by IMR (Clinical Trials.gov NCT 01582165, EUDRACT 2011-002630-39.3tcAZ).","[{'ForeName': 'Ole Geir', 'Initials': 'OG', 'LastName': 'Solberg', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Stavem', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Asgrimur', 'Initials': 'A', 'LastName': 'Ragnarsson', 'Affiliation': 'Department of Radiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Jan-Otto', 'Initials': 'JO', 'LastName': 'Beitnes', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Skårdal', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aaberge', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28157']
702,30799485,Randomized controlled trial of telephone-based cognitive-behavioral therapy on parenting self-efficacy and satisfaction.,"Developing a sense of parenting self-efficacy and satisfaction is essential for positive parenting and healthy development of the child. The present study evaluated the efficacy of a telephone-based cognitive-behavioral therapy (T-CBT) on parenting self-efficacy and satisfaction at 6 weeks and 6 months postpartum. A multi-site randomized controlled trial was conducted between July 2012 and March 2014. A total of 397 Chinese mothers at risk of postnatal depression were recruited through the postnatal units at three regional public hospitals in Hong Kong and were randomized to receive T- CBT (n = 197) or standard care (n = 200). The T-CBT consisted of five weekly 30-min sessions focusing on changing dysfunctional cognitions and developing problem-solving skills. Parenting self-efficacy and satisfaction were measured by the efficacy and satisfaction subscales of the Parenting Sense of Competence Scale (PSOC-E/S), respectively, at baseline, 6 weeks, and 6 months postpartum. When compared with standard care, T-CBT was associated with a significant improvement in parenting self-efficacy and satisfaction at 6 weeks postpartum (mean difference in PSOC-E: 2.85 [95% CI: 1.72-3.98], p < .001; mean difference in PSOC-S score: 1.61 [95% CI: 0.52-2.71], p = .004), and 6 months (mean difference in PSOC-E score: 3.37 [95% CI: 1.89-4.85], p < .001; mean difference in PSOC-S score: 2.39 [95% CI: 0.96-3.82], p = .001). T-CBT produced significantly greater improvement in parenting self-efficacy and satisfaction than standard care. The results highlight the potential of T-CBT as a promising treatment modality to facilitate maternal adaptation and promote a sense of parenting self-efficacy and satisfaction during the transition to new motherhood.",2019,"When compared with standard care, T-CBT was associated with a significant improvement in parenting self-efficacy and satisfaction at 6 weeks postpartum (mean difference in PSOC-E: 2.85 [95% CI: 1.72-3.98], p < .001; mean difference in PSOC-S score: 1.61 [95% CI: 0.52-2.71], p = .004), and 6 months (mean difference in PSOC-E score: 3.37 [95% CI: 1.89-4.85], p < .001; mean difference in PSOC-S score: 2.39 [95% CI: 0.96-3.82], p = .001).","['397 Chinese mothers at risk of postnatal depression were recruited through the postnatal units at three regional public hospitals in Hong Kong', 'July 2012 and March 2014']","['T- CBT', 'telephone-based cognitive-behavioral therapy', 'telephone-based cognitive-behavioral therapy (T-CBT']","['parenting self-efficacy and satisfaction', 'Parenting self-efficacy and satisfaction', 'efficacy and satisfaction subscales of the Parenting Sense of Competence Scale (PSOC-E/S']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}]",397.0,0.114283,"When compared with standard care, T-CBT was associated with a significant improvement in parenting self-efficacy and satisfaction at 6 weeks postpartum (mean difference in PSOC-E: 2.85 [95% CI: 1.72-3.98], p < .001; mean difference in PSOC-S score: 1.61 [95% CI: 0.52-2.71], p = .004), and 6 months (mean difference in PSOC-E score: 3.37 [95% CI: 1.89-4.85], p < .001; mean difference in PSOC-S score: 2.39 [95% CI: 0.96-3.82], p = .001).","[{'ForeName': 'Fei-Wan', 'Initials': 'FW', 'LastName': 'Ngai', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Paul Wai-Ching', 'Initials': 'PW', 'LastName': 'Wong', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ka-Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kwok-Yin', 'Initials': 'KY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Tarrant', 'Affiliation': 'The University of British Columbia, Canada.'}]",Translational behavioral medicine,['10.1093/tbm/ibz017']
703,31693746,Prospective Evaluation of Cognitive Outcomes After Anesthesia for Patients in the Beach Chair Position.,"The beach chair position has been popularized for shoulder surgeries, particularly those involving arthroscopy. Several published case reports and studies have raised concerns for neurologic complications related to anesthesia for surgery performed with patients in the beach chair position. The question has been raised whether cerebral perfusion monitoring should be used routinely to minimize these potential complications. This prospective study evaluated cognitive outcomes in patients who underwent anesthesia in the beach chair position. Patients were randomized to 2 groups. In group 1, the anesthesiologist was blinded to the cerebral monitoring and could treat based only on mean arterial pressure (MAP). In group 2, the anesthesiologist was aware of the results of the cerebral monitoring and could treat any desaturation events. All patients were evaluated pre- and postoperatively with a cognitive assessment tool. A total of 80 patients were enrolled in the study, with 40 patients in each group. There were no significant differences regarding age, body mass index, or American Society of Anesthesiologists score. Only 3 desaturation events occurred with no significant change in cognitive function. The findings indicate no advantage to cerebral perfusion monitoring during anesthesia for surgery performed with patients in the beach chair position as long as MAP is maintained within strict limits. Although little is known about the level of cerebral desaturation that will result in cognitive dysfunction, it may likely be related to MAP and cerebral perfusion. The findings of this study reinforce the need for careful monitoring of MAP during surgery and dispute the need for additional expensive monitoring devices. [Orthopedics. 2020; 43(1):e27-e30.].",2020,"There were no significant differences regarding age, body mass index, or American Society of Anesthesiologists score.","['patients who underwent anesthesia in the beach chair position', '80 patients were enrolled in the study, with 40 patients in each group']",[],"['cognitive function', 'body mass index, or American Society of Anesthesiologists score', 'mean arterial pressure (MAP', 'Cognitive Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2316745', 'cui_str': 'Deckchair position'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}]",80.0,0.0197491,"There were no significant differences regarding age, body mass index, or American Society of Anesthesiologists score.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Boukhemis', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Perez', 'Affiliation': ''}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Olness', 'Affiliation': ''}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Hensley', 'Affiliation': ''}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Lindstrom', 'Affiliation': ''}, {'ForeName': 'E Barry', 'Initials': 'EB', 'LastName': 'McDonough', 'Affiliation': ''}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Bal', 'Affiliation': ''}]",Orthopedics,['10.3928/01477447-20191031-09']
704,30741863,"Efficacy of Combined General, Special, and Specific Resistance Training on Pace Bowling Skill in Club-Standard Cricketers.","Feros, SA, Young, WB, and O'Brien, BJ. Efficacy of combined general, special, and specific resistance training on pace bowling skill in club-standard cricketers. J Strength Cond Res 34(9): 2596-2607, 2020-This study investigated the efficacy of combined ""general,"" ""special,"" and ""specific"" resistance training on pace bowling skill. Twelve male, club-standard pace bowlers were randomly allocated to a combined resistance training (CRT) program or traditional cricket training (TCT) program for 8 weeks. The CRT group (n = 6) trained with 300, 250-g, and standard cricket balls; performed 20-m sprints with +20% and +15% body mass resistance (but also unresisted); and completed chin-up and pull-up training. The TCT group (n = 6) trained with standard balls and performed unresisted 20-m sprints. No statistically significant GROUP × TIME interactions were identified. The CRT group demonstrated a ""clear moderate"" enhancement in peak ball release speed (mean ±95% confidence limits [CLs]: 1.2 ± 1.5 m·s, d = 0.66 ± 0.83), a ""clear large"" increase in mean radial error (mean ±95% CLs: 7.1 ± 6.5 cm, d = 0.94 ± 0.87), and a ""clear large"" rise in bivariate variable error (mean ±95% CLs: 7.2 ± 7.8 cm, d = 0.97 ± 1.05). The TCT group exhibited ""unclear"" changes across all pace bowling skill measures. Both groups displayed ""unclear"" changes in approach speed, 20-m sprint time, and 1 repetition maximum pull-up strength. In 8 weeks, the CRT program improved peak ball release speed, but at the cost of poorer bowling accuracy and consistency of bowling accuracy. These findings could be attributed to bowling with the heavier balls. The inclusion of ""specific"" resistance training does not seem to be effective in enhancing all-round pace bowling skill in club-standard cricketers.",2020,"The inclusion of ""specific"" resistance training does not seem to be effective in enhancing all-round pace bowling skill in club-standard cricketers.","['Twelve male, club-standard pace bowlers', ' 000-000', 'club-standard cricketers', 'Club-Standard Cricketers']","['TCT', 'J Strength Cond Res XX(X', 'combined resistance training (CRT) program or traditional cricket training (TCT) program', 'combined ""general,"" ""special,"" and ""specific"" resistance training', 'combined general, special, and specific resistance training', 'Combined General, Special, and Specific Resistance Training', '20-m sprints with +20% and +15% body mass resistance (but also unresisted); and completed chin-up and pull-up training']","['mean radial error', 'peak ball release speed', 'unclear"" changes in approach speed, 20-m sprint time, and 1 repetition maximum pull-up strength']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0018288', 'cui_str': 'Crickets'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}]",12.0,0.0179059,"The inclusion of ""specific"" resistance training does not seem to be effective in enhancing all-round pace bowling skill in club-standard cricketers.","[{'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Feros', 'Affiliation': 'Center for Sport Research, School of Exercise and Nutrition Sciences, Deakin University, Waurn Ponds, Victoria, Australia.'}, {'ForeName': 'Warren B', 'Initials': 'WB', 'LastName': 'Young', 'Affiliation': 'Faculty of Health, Federation University Australia, Mt. Helen, Victoria, Australia.'}, {'ForeName': 'Brendan J', 'Initials': 'BJ', 'LastName': 'OʼBrien', 'Affiliation': 'Faculty of Health, Federation University Australia, Mt. Helen, Victoria, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002940']
705,32408253,Effect of amino acids on IGF1 gene expression in human myotubes and skeletal muscle.,"OBJECTIVE


Insulin-like growth factor I (IGF1) is an important regulator of collagen and extracellular matrix protein expression. We aimed to evaluate the effect of amino acids (AAs) on expression of IGF1 and IGF1-dependent genes in human myotubes and skeletal muscle and supposed that AAs administration increases IGF1 levels in blood and expression of IGF1 and IGF1-dependent genes in trained skeletal muscle, thereby reducing training-induced muscle damage.
DESIGN


Human myotubes were incubated with Arg and Leu for 24 h. Then, the effects of long-term branched chain AAs administration (10 weeks, 0.1 g/kg body mass/day) to volunteers (six subjects per AAs and placebo groups) performing large training volumes regularly (cross country skiers, training twice a day) were examined.
RESULTS


Incubating the myotubes with AAs increases expression of IGF1 mRNA isoforms and IGF1 secretion by 2-3 times. In athletes, long-term AAs administration increased basal blood levels of IGF1 (~50%) and expression of IGF1Ea mRNA slightly in skeletal muscle. There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration. However, expression of these genes in the combined group (placebo + AAs; n = 12) significantly correlated with the expression of IGF1Ea mRNA in muscle and did not correlate with IGF1 levels in the blood.
CONCLUSIONS


AAs administration increases IGF1 expression in vitro and in vivo. To obtain more pronounced changes in expression of IGF1 and IGF1-dependent genes in skeletal muscle, it may be necessary to increase the dose and/or duration of AAs administration.",2020,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","['human myotubes and skeletal muscle', 'Human myotubes were incubated with Arg and Leu for 24\xa0h']","['Insulin-like growth factor', 'amino acids', 'amino acids (AAs']","['IGF1 gene expression', 'IGF1 expression', 'basal blood levels of IGF1', 'expression of IGF1 mRNA isoforms and IGF1 secretion', 'expression of IGF1Ea mRNA', 'expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle', 'IGF1 levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}]","[{'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0972255', 'cui_str': 'type I collagen alpha 1'}, {'cui': 'C0024375', 'cui_str': 'Protein-lysine 6-oxidase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.0302591,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","[{'ForeName': 'Egor M', 'Initials': 'EM', 'LastName': 'Lednev', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation. Electronic address: ledhauz@gmail.com.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Kravchenko', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Vladimir A', 'Initials': 'VA', 'LastName': 'Furalyov', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Evgeny A', 'Initials': 'EA', 'LastName': 'Lysenko', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Iulia S', 'Initials': 'IS', 'LastName': 'Lemesheva', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Alexandr A', 'Initials': 'AA', 'LastName': 'Grushin', 'Affiliation': 'Russian Olympic Committee, Luzhnetskaya Embankment 8, Russia, Moscow 119991, Russian Federation.'}, {'ForeName': 'Vadim E', 'Initials': 'VE', 'LastName': 'Dubrov', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, 27 build. 1, Lomonosovsky Prospekt, Moscow 119991, Russian Federation.'}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Vinogradova', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Daniil V', 'Initials': 'DV', 'LastName': 'Popov', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101323']
706,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
707,30520976,Association of Body Fat and Risk of Breast Cancer in Postmenopausal Women With Normal Body Mass Index: A Secondary Analysis of a Randomized Clinical Trial and Observational Study.,"Importance


Obesity is associated with an increased risk of breast cancer, including the estrogen receptor (ER)-positive subtype in postmenopausal women. Whether excess adiposity is associated with increased risk in women with a normal body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) is unknown.
Objective


To investigate the association between body fat and breast cancer risk in women with normal BMI.
Design, Setting, and Participants


This ad hoc secondary analysis of the Women's Health Initiative (WHI) clinical trial and observational study cohorts was restricted to postmenopausal participants with a BMI ranging from 18.5 to 24.9. Women aged 50 to 79 years were enrolled from October 1, 1993, through December 31, 1998. Of these, 3460 participants underwent body fat measurement with dual-energy x-ray absorptiometry (DXA) at 3 US designated centers with follow-up. At a median follow-up of 16 years (range, 9-20 years), 182 incident breast cancers had been ascertained, and 146 were ER positive. Follow-up was complete on September 30, 2016, and data from October 1, 1993, through September 30, 2016, was analyzed August 2, 2017, through August 21, 2018.
Main Outcomes and Measures


Body fat levels were measured at baseline and years 1, 3, 6, and 9 using DXA. Information on demographic data, medical history, and lifestyle factors was collected at baseline. Invasive breast cancers were confirmed via central review of medical records by physician adjudicators. Blood analyte levels were measured in subsets of participants.
Results


Among the 3460 women included in the analysis (mean [SD] age, 63.6 [7.6] years), multivariable-adjusted hazard ratios for the risk of invasive breast cancer were 1.89 (95% CI, 1.21-2.95) for the highest quartile of whole-body fat and 1.88 (95% CI, 1.18-2.98) for the highest quartile of trunk fat mass. The corresponding adjusted hazard ratios for ER-positive breast cancer were 2.21 (95% CI, 1.23-3.67) and 1.98 (95% CI, 1.18-3.31), respectively. Similar positive associations were observed for serial DXA measurements in time-dependent covariate analyses. Circulating levels of insulin, C-reactive protein, interleukin 6, leptin, and triglycerides were higher, whereas levels of high-density lipoprotein cholesterol and sex hormone-binding globulin were lower in those in the uppermost vs lowest quartiles of trunk fat mass.
Conclusions and Relevance


In postmenopausal women with normal BMI, relatively high body fat levels were associated with an elevated risk of invasive breast cancer and altered levels of circulating metabolic and inflammatory factors. Normal BMI categorization may be an inadequate proxy for the risk of breast cancer in postmenopausal women.
Trial Registration


ClinicalTrials.gov identifier: NCT00000611.",2019,"Circulating levels of insulin, C-reactive protein, interleukin 6, leptin, and triglycerides were higher, whereas levels of high-density lipoprotein cholesterol and sex hormone-binding globulin were lower in those in the uppermost vs lowest quartiles of trunk fat mass.
","['postmenopausal women', 'Women aged 50 to 79 years were enrolled from October 1, 1993, through December 31, 1998', 'Invasive breast cancers', 'postmenopausal participants with a BMI ranging from 18.5 to 24.9', '3460 women included in the analysis (mean [SD] age, 63.6 [7.6] years', 'Postmenopausal Women With Normal Body Mass Index', 'postmenopausal women with normal BMI', '3460 participants underwent', 'women with normal BMI']",['body fat measurement with dual-energy x-ray absorptiometry (DXA'],"['demographic data, medical history, and lifestyle factors', 'Blood analyte levels', 'Measures\n\n\nBody fat levels', 'Circulating levels of insulin, C-reactive protein, interleukin 6, leptin, and triglycerides', 'Body Fat and Risk of Breast Cancer', 'levels of high-density lipoprotein cholesterol and sex hormone-binding globulin', 'serial DXA measurements']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0005768'}, {'cui': 'C0443354', 'cui_str': 'Analyte (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",3460.0,0.257959,"Circulating levels of insulin, C-reactive protein, interleukin 6, leptin, and triglycerides were higher, whereas levels of high-density lipoprotein cholesterol and sex hormone-binding globulin were lower in those in the uppermost vs lowest quartiles of trunk fat mass.
","[{'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Iyengar', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Arthur', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Candyce H', 'Initials': 'CH', 'LastName': 'Kroenke', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University in Saint Louis, St Louis, Missouri.'}, {'ForeName': 'Ting-Yuan D', 'Initials': 'TD', 'LastName': 'Cheng', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Feliciano', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Lane', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook University School of Medicine, Stony Brook, New York.'}, {'ForeName': 'Juhua', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University, Indianapolis.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Nassir', 'Affiliation': 'Department of Biochemistry and Molecular Medicine, University of California, Davis.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Pan', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA (University of California, Los Angeles) Medical Center, Los Angeles.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Wassertheil-Smoller', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kamensky', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Rohan', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Dannenberg', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York.'}]",JAMA oncology,['10.1001/jamaoncol.2018.5327']
708,30593701,Effectiveness of a protocol for teaching dental tooth color in students with color vision impairment.,"OBJECTIVE


In patients with color vision alterations (CVA), the correct determination of color is altered, but not the detection of changes in luminosity or value. There is no accepted training protocol for dental value selection in dental students with CVA. The objective of this pilot study was to determine the effectiveness of a dental color training protocol based on the dental value selection.
MATERIALS AND METHODS


An intervention study was carried out on dental students in a University setting, applying a specific dental color training protocol on two groups of students. Group 1:4 students with CVA, Group 2:4 healthy students. A third group of four students without intervention was used as a control group. An initial diagnostic test was applied, which was reapplied at the end of the training.
RESULTS


The number of errors in the selection of the dental color decreased after training in all three groups, P > .05. For the value parameter, there was a statistically significant decrease in the number of errors after training (P = .014).
CONCLUSIONS


The applied training protocol could be of help in students with CVA, but multicenter studies are needed.
CLINICAL SIGNIFICANCE


Level 3 evidence level.",2020,"The number of errors in the selection of the dental color decreased after training in all three groups, P > .05.","['dental students in a University setting, applying a specific dental color training protocol on two groups of students', 'patients with color vision alterations (CVA', 'dental students with CVA', 'students with color vision impairment', 'Group 1:4 students with CVA, Group 2:4 healthy students']",['dental color training protocol'],"['number of errors', 'number of errors in the selection of the dental color']","[{'cui': 'C0038493', 'cui_str': 'Students, Dental'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522507', 'cui_str': 'With color (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",4.0,0.0170751,"The number of errors in the selection of the dental color decreased after training in all three groups, P > .05.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rioseco', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'Duniel', 'Initials': 'D', 'LastName': 'Ortuño', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'María F', 'Initials': 'MF', 'LastName': 'Cortés', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Costa', 'Affiliation': 'School of Dentistry, Faculty of Medicine, Pontificia Universidad Católica de Chile, Macul, Santiago, Chile.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12451']
709,31667501,Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness.,"INTRODUCTION


High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population.
METHODS


In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16.
RESULTS


Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions.
CONCLUSIONS


This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI.
IMPLICATIONS


This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.",2020,"At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs 5.9 for QuitGuide; p<0.01).","['Individuals with Co-Occurring Tobacco Dependence and Serious Mental Illness', 'people with serious mental illness (SMI', 'larger sample of smokers with SMI', 'Daily smokers with SMI (N=62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16', 'patients with co-occurring tobacco use disorder and serious mental illness']","['nicotine replacement therapy and technical assistance', 'Novel Smoking Cessation App', 'Learn to Quit versus QuitGuide']","['higher usability scores', 'prevalence abstinence', 'psychiatric symptoms and adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040336', 'cui_str': 'Tobacco Use Disorder'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.229352,"At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs 5.9 for QuitGuide; p<0.01).","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vilardaga', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rizo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Palenski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mannelli', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Oliver', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Mcclernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz202']
710,30040523,Double-Blind Phase III Trial of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer (E5103).,"Purpose Bevacizumab improves progression-free survival but not overall survival in patients with metastatic breast cancer. E5103 tested the effect of bevacizumab in the adjuvant setting in patients with human epidermal growth factor receptor 2-negative disease. Patients and Methods Patients were assigned 1:2:2 to receive placebo with doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (arm A), bevacizumab only during AC and paclitaxel (arm B), or bevacizumab during AC and paclitaxel followed by bevacizumab monotherapy for 10 cycles (arm C). Random assignment was stratified and bevacizumab dose adjusted for choice of AC schedule. Radiation and hormonal therapy were administered concurrently with bevacizumab in arm C. The primary end point was invasive disease-free survival (IDFS). Results Four thousand nine hundred ninety-four patients were enrolled. Median age was 52 years; 64% of patients were estrogen receptor positive, 27% were lymph node negative, and 78% received dose-dense AC. Chemotherapy-associated adverse events including myelosuppression and neuropathy were similar across all arms. Grade ≥ 3 hypertension was more common in bevacizumab-treated patients, but thrombosis, proteinuria, and hemorrhage were not. The cumulative incidence of clinical congestive heart failure at 15 months was 1.0%, 1.9%, and 3.0% in arms A, B, and C, respectively. Bevacizumab exposure was less than anticipated, with approximately 24% of patients in arm B and approximately 55% of patients in arm C discontinuing bevacizumab before completing planned therapy. Five-year IDFS was 77% (95% CI, 71% to 81%) in arm A, 76% (95% CI, 72% to 80%) in arm B, and 80% (95% CI, 77% to 83%) in arm C. Conclusion Incorporation of bevacizumab into sequential anthracycline- and taxane-containing adjuvant therapy does not improve IDFS or overall survival in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer. Longer duration bevacizumab therapy is unlikely to be feasible given the high rate of early discontinuation.",2018,"Five-year IDFS was 77% (95% CI, 71% to 81%) in arm A, 76% (95% CI, 72% to 80%) in arm B, and 80% (95% CI, 77% to 83%) in arm C. Conclusion Incorporation of bevacizumab into sequential anthracycline- and taxane-containing adjuvant therapy does not improve IDFS or overall survival in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer.","['patients with metastatic breast cancer', 'patients with high-risk human epidermal growth factor receptor 2-negative breast cancer', 'Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer', 'Results Four thousand nine hundred ninety-four patients were enrolled', 'patients with human epidermal growth factor receptor 2-negative disease']","['Adjuvant Chemotherapy', 'placebo with doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (arm A), bevacizumab only during AC and paclitaxel (arm B), or bevacizumab during AC and paclitaxel followed by bevacizumab monotherapy', 'bevacizumab', 'taxane-containing adjuvant therapy', 'Radiation and hormonal therapy', 'Bevacizumab']","['invasive disease-free survival (IDFS', 'IDFS or overall survival', 'cumulative incidence of clinical congestive heart failure', 'progression-free survival', 'thrombosis, proteinuria, and hemorrhage', 'myelosuppression and neuropathy', 'Grade ≥']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",4994.0,0.21751,"Five-year IDFS was 77% (95% CI, 71% to 81%) in arm A, 76% (95% CI, 72% to 80%) in arm B, and 80% (95% CI, 77% to 83%) in arm C. Conclusion Incorporation of bevacizumab into sequential anthracycline- and taxane-containing adjuvant therapy does not improve IDFS or overall survival in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer.","[{'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Neill"", 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gradishar', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Hobday', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Goldstein', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Bloom', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brufsky', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Nguyet Anh', 'Initials': 'NA', 'LastName': 'Le-Lindqwister', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Hendricks', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': ""Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Anne O'Neill, Dana-Farber Cancer Institute, Boston, MA; William Gradishar, Northwestern University, Chicago; Nguyet Anh Le-Lindqwister, Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Peoria, IL; Timothy J. Hobday, Mayo Clinic, Rochester; Stuart Bloom, Abbott Northwestern Hospital, Minneapolis, MN; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia; Adam M. Brufsky, University of Pittsburgh, Pittsburgh, PA; Ingrid A. Mayer, Vanderbilt University, Nashville, TN; Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Joseph A. Sparano, Montefiore Hospital and Medical Center, Bronx; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York, NY; Carolyn B. Hendricks, Association Community Clinical Oncology Program, Bethesda, MD; Donald W. Northfelt, Mayo Clinic, Scottsdale, AZ; and George W. Sledge JR, Stanford University, Stanford, CA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.79.2028']
711,28497259,Safety and Tolerability of Intravenous Valproic Acid in Healthy Subjects: A Phase I Dose-Escalation Trial.,"BACKGROUND


Valproic acid, a histone deacetylase inhibitor, has beneficial effects in the setting of cancer, neurologic diseases, and traumatic injuries. In animal models of traumatic injury, a single dose of valproic acid has been shown to reduce mortality. The purpose of this trial was to determine the maximum tolerated single dose of intravenous valproic acid in healthy humans.
METHODS


A double-blinded, placebo-controlled, dose-escalation trial design was used to identify dose-limiting toxicities in healthy subjects who received a single dose of intravenous valproic acid. Patients were monitored for adverse events and data were collected for pharmacokinetic, pharmacodynamic, and safety profiling of valproic acid.
RESULTS


Fifty-nine healthy subjects (mean 30 ± 12 years) were enrolled. Forty-four subjects received valproic acid in doses from 15 to 150 mg/kg. The most common adverse events were hypoacusis (n = 19), chills (n = 18), and headache (n = 16). The maximum tolerated dose was 140 mg/kg. Dose-limiting toxicities included headache and nausea lasting longer than 12 h. No drug-related abnormalities were seen in other safety measures including laboratory tests, hemodynamic parameters, cardiac rhythm monitoring, and cognitive testing. A two-compartment model was predictive of valproic acid concentration-time profiles, with a strong correlation (R  2  = 0.56) observed between the number of reported adverse events and the dose level.
CONCLUSIONS


The maximum tolerated dose of intravenous valproic acid in healthy subjects is 140 mg/kg. This is significantly higher than the previously established maximum tolerated dose of 60-75 mg/kg. Next, the safety and tolerability of high-dose valproic acid will be tested in trauma patients in hemorrhagic shock. ClinicalTrials.gov Identifier: NCT01951560.",2018,"No drug-related abnormalities were seen in other safety measures including laboratory tests, hemodynamic parameters, cardiac rhythm monitoring, and cognitive testing.","['healthy humans', 'trauma patients in hemorrhagic shock', 'healthy subjects', 'Healthy Subjects', 'healthy subjects who received a single dose of', 'Fifty-nine healthy subjects (mean 30\xa0±\xa012\xa0years) were enrolled']","['intravenous valproic acid', 'placebo', 'Intravenous Valproic Acid', 'high-dose valproic acid', 'valproic acid']","['pharmacokinetic, pharmacodynamic, and safety profiling of valproic acid', 'safety and tolerability', 'Safety and Tolerability', 'laboratory tests, hemodynamic parameters, cardiac rhythm monitoring, and cognitive testing', 'headache', 'headache and nausea lasting longer', 'chills', 'valproic acid concentration-time profiles']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0042291', 'cui_str': 'Valproic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042291', 'cui_str': 'Valproic Acid'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",59.0,0.158593,"No drug-related abnormalities were seen in other safety measures including laboratory tests, hemodynamic parameters, cardiac rhythm monitoring, and cognitive testing.","[{'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Georgoff', 'Affiliation': 'Department of General Surgery, University of Michigan Medical School, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Vahagn C', 'Initials': 'VC', 'LastName': 'Nikolian', 'Affiliation': 'Department of General Surgery, University of Michigan Medical School, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Bonham', 'Affiliation': 'Department of General Surgery, University of Michigan Medical School, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Manjunath P', 'Initials': 'MP', 'LastName': 'Pai', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Tafatia', 'Affiliation': 'Department of General Surgery, University of Michigan Medical School, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Halaweish', 'Affiliation': 'Department of General Surgery, University of Michigan Medical School, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'To', 'Affiliation': 'Department of General Surgery, University of Michigan Medical School, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Kuanwong', 'Initials': 'K', 'LastName': 'Watcharotone', 'Affiliation': 'Michigan Institute for Clinical and Health Research, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Parameswaran', 'Affiliation': 'Michigan Institute for Clinical and Health Research, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Duxin', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of General Surgery, University of Michigan Medical School, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA. alamh@med.umich.edu.'}]",Clinical pharmacokinetics,['10.1007/s40262-017-0553-1']
712,32408361,22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy.,"BACKGROUND : Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has been suggested for obtaining high quality tissue samples from pancreatic tumors. We performed a multicenter randomized crossover trial comparing EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle. The aims were to compare the quantity of targeted tissue (pancreas) and diagnostic accuracy for the two needles. METHODS : 60 patients admitted for EUS-FNB in three endoscopy units were included. One pass was performed consecutively with each needle, in a randomized order. Histologic material was studied in a blinded manner with respect to the needle. The primary end point was mean cumulative length of tissue core biopsies per needle pass. RESULTS : Final diagnosis was adenocarcinoma (n = 46; 77 %), neuroendocrine neoplasm (n = 11; 18 %), autoimmune pancreatitis (n = 2), and mass-forming chronic pancreatitis (n = 1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22G Acquire needle at 11.4 mm (95 % confidence interval [CI] 9.0 - 13.8] vs. 5.4 mm (95 %CI 3.8 - 7.0) for the 20G Procore needle ( P  < 0.001), as was the mean surface area (3.5 mm 2  [95 %CI 2.7 - 4.3] vs. 1.8 mm 2  [95 %CI 1.2 - 2.3];  P  < 0.001). Diagnostic adequacy and accuracy were 100 % and 87 % with the 22G Acquire needle, and 82 % and 67 % with the 20G Procore needle ( P  = 0.001 and  P  = 0.02, respectively). CONCLUSIONS : EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.",2020,EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.,['60 patients admitted for EUS-FNB in three endoscopy units were included'],"['Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB', '22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses', 'EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle']","['quantity of targeted tissue (pancreas) and diagnostic accuracy', 'Diagnostic adequacy and accuracy', 'autoimmune pancreatitis', 'mean cumulative length of tissue core biopsies per needle pass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C2609129', 'cui_str': 'Autoimmune pancreatitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",60.0,0.0430272,EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Karsenti', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Palazzo', 'Affiliation': 'Digestive Endoscopy Unit, Clinique du Trocadéro, Paris, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Perrot', 'Affiliation': 'UMR1246_SPHERE Methods for Patient-Centered Outcomes and Health Research, Nantes University, France.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Zago', 'Affiliation': 'Pathology Department, 29 rue du Colisée, Paris, France.'}, {'ForeName': 'Anne-Isabelle', 'Initials': 'AI', 'LastName': 'Lemaistre', 'Affiliation': 'Department of Pathology, Eurofins Biomnis, Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon Hospital, Pathology Department, Université de Paris, INSERM U1149, Clichy, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Napoléon', 'Affiliation': 'Digestive Endoscopy Unit, Hôpital Privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France.'}]",Endoscopy,['10.1055/a-1160-5485']
713,30658560,Weight-Loss Resilience Among Low-Income Postpartum Women: Association With Health Habits.,"Using a weight resilience framework, health habits of diet and physical activity, social support, and perceived stress were compared in women who lost weight (resilient) and those who did not lose or gained weight (nonresilient) during a weight-loss intervention. Participants were low-income postpartum women participating in a 13-week randomized treatment-control group intervention, with 20 of 50 classified as resilient in losing weight. Measures included the Postpartum Support Scale, the Perceived Stress Scale, and health habit items from the Self Care Inventory. Weight-loss resilient women showed significantly more frequent healthful dietary habits, such as eating a nutritious breakfast, and less frequent unhealthy habits, such as substituting junk food for meals, and less perceived stress than their nonresilient counterparts at both the midpoint and end of the study. Weight-loss resilient women also showed significantly more frequent physical activity habits at the end of the study. No social support differences were found.",2019,"Weight-loss resilient women showed significantly more frequent healthful dietary habits, such as eating a nutritious breakfast, and less frequent unhealthy habits, such as substituting junk food for meals, and less perceived stress than their nonresilient counterparts at both the midpoint and end of the study.","['Participants were low-income postpartum women participating', 'women who lost weight (resilient) and those who did not lose or gained weight (nonresilient) during a weight-loss intervention']",[],"['frequent physical activity habits', 'Postpartum Support Scale, the Perceived Stress Scale, and health habit items from the Self Care Inventory', 'Weight-Loss Resilience']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",[],"[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0222045'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0139034,"Weight-loss resilient women showed significantly more frequent healthful dietary habits, such as eating a nutritious breakfast, and less frequent unhealthy habits, such as substituting junk food for meals, and less perceived stress than their nonresilient counterparts at both the midpoint and end of the study.","[{'ForeName': 'Lorraine O', 'Initials': 'LO', 'LastName': 'Walker', 'Affiliation': 'The University of Texas at Austin, TX, USA.'}, {'ForeName': 'Sookja', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'The University of Texas at Austin, TX, USA.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'S Sterling', 'Affiliation': 'The University of Texas at Austin, TX, USA.'}]",Western journal of nursing research,['10.1177/0193945918824598']
714,27981257,Assessing the efficacy of vaginal hyoscine butyl bromide on cervical ripening prior to intrauterine procedures: A double-blinded clinical trial.,"BACKGROUND


Unripe cervix prevents entering the endometrial cavity during intrauterine procedures. Mechanical dilatation of cervical canal might cause undesirable complications.
OBJECTIVE


To investigate the substitute of mechanical intervention with chemical treatment by administering hyoscine to patients.
MATERIALS AND METHODS


Sixty non-pregnant women, 20-70 years of age, with a closed cervix who were scheduled for an intrauterine procedure, were randomly divided into two groups. Group A as experimental (received two doses of hyoscine) and group B, as control group (received two doses of vitamin B6) in the vagina (8 hrs and 2 hrs before procedure) and the effect of these two drugs on dilatation and consistency of cervix were studied.
RESULTS


Statistics resulted from Mann-Whitney U test (p=0.027) and  2 (p=0.002) indicated that in premenopausal women, the priming effect of hyoscine on dilatation and consistency of uterine cervix was significant, but there were no significant benefits from giving vaginal hyoscine to menopausal women preoperatively (p=0.603).
CONCLUSION


Hyoscine proved a good choice for inducing cervical priming before intrauterine procedures in premenopausal women.",2016,"RESULTS


Statistics resulted from Mann-Whitney U test (p=0.027) and  2 (p=0.002) indicated that in premenopausal women, the priming effect of hyoscine on dilatation and consistency of uterine cervix was significant, but there were no significant benefits from giving vaginal hyoscine to menopausal women preoperatively (p=0.603).
","['premenopausal women', 'Sixty non-pregnant women, 20-70 years of age, with a closed cervix who were scheduled for an intrauterine procedure', 'to patients', 'cervical ripening prior to intrauterine procedures']","['vitamin B6', 'hyoscine', 'Hyoscine', 'vaginal hyoscine', 'vaginal hyoscine butyl bromide']",['dilatation and consistency of uterine cervix'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0626372', 'cui_str': '1-bromobutane'}]","[{'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1286001', 'cui_str': 'Consistency of uterine cervix'}]",,0.139614,"RESULTS


Statistics resulted from Mann-Whitney U test (p=0.027) and  2 (p=0.002) indicated that in premenopausal women, the priming effect of hyoscine on dilatation and consistency of uterine cervix was significant, but there were no significant benefits from giving vaginal hyoscine to menopausal women preoperatively (p=0.603).
","[{'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Hadadian', 'Affiliation': 'Preventative Gynecology Research Center, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Fallahian', 'Affiliation': 'Preventative Gynecology Research Center, Shahid Beheshti University of Medical Science, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
715,31740017,Cardiovascular Effects of Switching From Tobacco Cigarettes to Electronic Cigarettes.,"BACKGROUND


E-cigarette (EC) use is increasing exponentially worldwide. The early cardiovascular effects of switching from tobacco cigarettes (TC) to EC in chronic smokers is unknown. Meta-analysis of flow-mediated dilation (FMD) studies indicate 13% lower pooled, adjusted relative risks of cardiovascular events with every 1% improvement in FMD.
OBJECTIVES


This study sought to determine the early vascular impact of switching from TC to EC in chronic smokers.
METHODS


The authors conducted a prospective, randomized control trial with a parallel nonrandomized preference cohort and blinded endpoint of smokers ≥18 years of age who had smoked ≥15 cigarettes/day for ≥2 years and were free from established cardiovascular disease. Participants were randomized to EC with nicotine or EC without nicotine for 1 month. Those unwilling to quit continued with TC in a parallel preference arm. A propensity score analysis was done to adjust for differences between the randomized and preference arms. Vascular function was assessed by FMD and pulse wave velocity. Compliance with EC was measured by carbon monoxide levels.
RESULTS


Within 1 month of switching from TC to EC, there was a significant improvement in endothelial function (linear trend β = 0.73%; 95% confidence interval [CI]: 0.41 to 1.05; p < 0.0001; TC vs. EC combined: 1.49%; 95% CI: 0.93 to 2.04; p < 0.0001) and vascular stiffness (-0.529 m/s; 95% CI: -0.946 to -0.112; p = 0.014). Females benefited from switching more than males did in every between-group comparison. Those who complied best with EC switch demonstrated the largest improvement. There was no difference in vascular effects between EC with and without nicotine within the study timeframe.
CONCLUSIONS


TC smokers, particularly females, demonstrate significant improvement in vascular health within 1 month of switching from TC to EC. Switching from TC to EC may be considered a harms reduction measure. (Vascular Effects of Regular Cigarettes Versus Electronic Cigarette Use [VESUVIUS]; NCT02878421; ISRCTN59133298).",2019,"There was no difference in vascular effects between EC with and without nicotine within the study time frame.
","['chronic smokers', 'smokers ≥18 years of age who had smoked\xa0≥15 cigarettes/day for\xa0≥2 years and were free from established cardiovascular disease']","['EC with nicotine or EC without nicotine', 'Regular Cigarettes', 'switching from tobacco cigarettes (TC) to EC', 'TC to EC']","['vascular health', 'vascular stiffness', 'vascular effects', 'Vascular function', 'endothelial function']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.133449,"There was no difference in vascular effects between EC with and without nicotine within the study time frame.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom. Electronic address: j.george@dundee.ac.uk.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Thenmalar', 'Initials': 'T', 'LastName': 'Vadiveloo', 'Affiliation': 'Population Health and Genomics Division, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ireland', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Hopkinson', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Population Health and Genomics Division, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Faisel', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Division of Systems Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.067']
716,30617276,"Correction: Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).",Supplementary Figure 1 and Supplementary Tables 1-4 have been re-uploaded so as to reflect the versions supplied during proofs stage. The publisher apologizes for the error in versioning. The HTML version of the paper has been updated.,2020,The publisher apologizes for the error in versioning.,['treatment-resistant depression (TRD'],"['ketamine', 'placebo']",[],"[{'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.237743,The publisher apologizes for the error in versioning.,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0311-2']
717,29106665,Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143.,"Background


Immunotherapies have demonstrated efficacy across a diverse set of tumors supporting further evaluation in glioblastoma. The objective of this study was to evaluate the safety/tolerability and describe immune-mediated effects of nivolumab ± ipilimumab in patients with recurrent glioblastoma. Exploratory efficacy outcomes are also reported.
Methods


Patients were randomized to receive nivolumab 3 mg/kg every 2 weeks (Q2W; NIVO3) or nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks (Q3W) for 4 doses, then nivolumab 3 mg/kg Q2W (NIVO1+IPI3). An alternative regimen of nivolumab 3 mg/kg + ipilimumab 1 mg/kg Q3W for 4 doses, then nivolumab 3 mg/kg Q2W (NIVO3+IPI1) was investigated in a nonrandomized arm.
Results


Forty patients were enrolled (NIVO3, n = 10; NIVO1+IPI3, n = 10; NIVO3+IPI1, n = 20). The most common treatment-related adverse events (AEs) were fatigue (NIVO3, 30%; NIVO1+IPI3, 80%; NIVO3+IPI1, 55%) and diarrhea (10%, 70%, 30%, respectively). AEs leading to discontinuation occurred in 10% (NIVO3), 30% (NIVO1+IPI3), and 20% (NIVO3+IPI1) of patients. Three patients achieved a partial response (NIVO3, n = 1; NIVO3+IPI1, n = 2) and 8 had stable disease for ≥12 weeks (NIVO3, n = 2; NIVO1+IPI3, n = 2; NIVO3+IPI1, n = 4 [Response Assessment in Neuro-Oncology criteria]). Most patients (68%) had tumor-cell programmed death ligand-1 expression ≥1%. Immune-mediated effects mimicking radiographic progression occurred in 2 patients.
Conclusions


Nivolumab monotherapy was better tolerated than nivolumab + ipilimumab; the tolerability of the combination was influenced by ipilimumab dose. These safety and exploratory findings merit further investigation of immunotherapies in glioblastoma.",2018,"AEs leading to discontinuation occurred in 10% (NIVO3), 30% (NIVO1+IPI3), and 20% (NIVO3+IPI1) of patients.","['Three patients achieved a partial response (NIVO3, n = 1; NIVO3+IPI1, n = 2) and 8 had stable disease for ≥12 weeks ', 'Forty patients were enrolled (NIVO3, n = 10; NIVO1+IPI3, n = 10; NIVO3+IPI1, n = 20', 'patients with recurrent glioblastoma', '2 patients']","['nivolumab 3 mg/kg Q2W (NIVO3+IPI1', 'nivolumab 3 mg/kg Q2W (NIVO1+IPI3', 'Nivolumab with or without ipilimumab', 'nivolumab 3 mg/kg + ipilimumab', 'nivolumab + ipilimumab', 'nivolumab ± ipilimumab', 'nivolumab 3 mg/kg every 2 weeks (Q2W; NIVO3) or nivolumab 1 mg/kg + ipilimumab']","['diarrhea', 'safety/tolerability', 'radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",40.0,0.0974267,"AEs leading to discontinuation occurred in 10% (NIVO3), 30% (NIVO1+IPI3), and 20% (NIVO3+IPI1) of patients.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Omuro', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Vlahovic', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lim', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Sahebjam', 'Affiliation': 'Moffitt Cancer Center, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Baehring', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Cloughesy', 'Affiliation': 'University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Voloschin', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Shakti H', 'Initials': 'SH', 'LastName': 'Ramkissoon', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Ligon', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Latek', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Zwirtes', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Strauss', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Prashni', 'Initials': 'P', 'LastName': 'Paliwal', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Harbison', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Sampson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}]",Neuro-oncology,['10.1093/neuonc/nox208']
718,31685792,Effect of dapagliflozin on obstructive sleep apnea in patients with type 2 diabetes: a preliminary study.,"OBJECTIVE


The aim of this case-control study was to assess the efficacy of dapagliflozin combined with metformin for type-2 diabetes mellitus (T2DM) with obstructive sleep apnea hypopnea syndrome (OSAHS).
METHODS


A total of 36 patients with newly-diagnosed T2DM and OSAHS were randomized divided into two groups. Eighteen OSAHS patients with T2DM, who were treated with dapagliflozin and metformin, were assigned as the dapagliflozin group. These patients were given dapagliflozin and metformin for 24 weeks between February 2017 and February 2018. Another 18 OSAHS patients with T2DM, who were treated with glimepiride and metformin for 24 weeks, were assigned as the control group. Fasting plasma glucose (FPG) level, postprandial blood glucose (PPG), hemoglobin A1C (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, body mass index (BMI), blood pressure, apnea-hypopnea index (AHI), minimum oxygen saturation (LSpO 2 ), and Epworth Somnolence Scale (ESS) score were measured before and at 24 weeks after the initiation of treatment.
RESULTS


In the dapagliflozin group, triglyceride (TG), systolic pressure (SBP) and diastolic pressure (DBP) significantly decreased following treatment, while high-density lipoprotein cholesterol (HDL-C) significantly increased (P < 0.05). Furthermore, a reduction in AHI, an increase in LSpO 2  and a decrease in ESS score were observed in the dapagliflozin group (P < 0.05), but not in the control group. Moreover, blood glucose, HbA1c, HOMA-IR, and BMI significantly decreased in these two groups, and the decrease was more significant in the dapagliflozin group.
CONCLUSION


These present results indicate that dapagliflozin can significantly reduce glucose, BMI, blood pressure and AHI, and improve hypoxemia during sleep and excessive daytime sleepiness, which thereby has potential as an effective treatment approach for OSAHS.",2019,"Moreover, blood glucose, HbA1c, HOMA-IR, and BMI significantly decreased in these two groups, and the decrease was more significant in the dapagliflozin group.
","['for 24 weeks between February 2017 and February 2018', 'Eighteen OSAHS patients with T2DM', '36 patients with newly-diagnosed T2DM and OSAHS', 'type-2 diabetes mellitus (T2DM) with obstructive sleep apnea hypopnea syndrome (OSAHS', 'patients with type 2 diabetes', 'Another 18 OSAHS patients with T2DM']","['dapagliflozin', 'dapagliflozin combined with metformin', 'dapagliflozin and metformin', 'glimepiride and metformin']","['ESS score', 'glucose, BMI, blood pressure and AHI, and improve hypoxemia during sleep and excessive daytime sleepiness', 'obstructive sleep apnea', 'blood glucose, HbA1c, HOMA-IR, and BMI', 'Fasting plasma glucose (FPG) level, postprandial blood glucose (PPG), hemoglobin A1C (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, body mass index (BMI), blood pressure, apnea-hypopnea index (AHI), minimum oxygen saturation (LSpO 2 ), and Epworth Somnolence Scale (ESS) score', 'triglyceride (TG), systolic pressure (SBP) and diastolic pressure (DBP', 'high-density lipoprotein cholesterol (HDL-C']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic Pressure'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}]",,0.0118343,"Moreover, blood glucose, HbA1c, HOMA-IR, and BMI significantly decreased in these two groups, and the decrease was more significant in the dapagliflozin group.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Endocrinology, The Fifth People's Hospital of Chengdu, 611130, Chengdu, P.R. China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""Center of Diabetes Mellitus, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, 610072, Chengdu, P. R. China. sunqin1947@163.com.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Bai', 'Affiliation': ""Department of Respiratory, The Fifth People's Hospital of Chengdu, 611130, Chengdu, P.R. China.""}, {'ForeName': 'Yun-Fan', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Chengdu, 610000, Chengdu, P.R. China.""}, {'ForeName': 'Qiong-Lan', 'Initials': 'QL', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, People's Hospital of Yilong County, 637676, Yilong, P.R. China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Center of Diabetes Mellitus, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, 610072, Chengdu, P. R. China. zhangmcd@163.com.""}]",Nutrition & diabetes,['10.1038/s41387-019-0098-5']
719,31690107,Nonparticipation reasons in a randomized international trial of a new latent tuberculosis infection regimen.,"BACKGROUND/AIMS


Efficient recruitment of eligible participants, optimizing time and sample size, is a crucial component in conducting a successful clinical trial. Inefficient participant recruitment can impede study progress, consume staff time and resources, and limit quality and generalizability or the power to assess outcomes. Recruitment for disease prevention trials poses additional challenges because patients are asymptomatic. We evaluated candidates for a disease prevention trial to determine reasons for nonparticipation and to identify factors that can be addressed to improve recruitment efficiency.
METHODS


During 2001-2009, the Tuberculosis Trials Consortium conducted Study 26 (PREVENT TB), a randomized clinical trial at 26 sites in four countries, among persons with latent tuberculosis infection at high risk for tuberculosis disease progression, comparing 3 months of directly observed once-weekly rifapentine plus isoniazid with 9 months of self-administered daily isoniazid. During March 2005-February 2008, non-identifying demographic information, risk factors for experiencing active tuberculosis disease, and reasons for not enrolling were collected from screened patients to facilitate interpretation of trial data, to meet Consolidated Standards of Reporting Trials standards, and to evaluate reasons for nonparticipation.
RESULTS


Of the 7452 candidates screened in Brazil, Canada, Spain, and the United States, 3584 (48%) were not enrolled, because of ineligibility (41%), site decision (10%), or patient choice (49%). Among those who did not enroll by own choice, and for whom responses were recorded on whether they would accept treatment outside of the study (n = 1430), 68% reported that they planned to accept non-study latent tuberculosis infection treatment. Among 1305 patients with one or more reported reasons for nonparticipation, study staff recorded a total of 1886 individual reasons (reason count: median = 1/patient; range = 1-9) for why patients chose not to enroll, including grouped concerns about research (24% of 1886), work or school conflicts (20%), medication or health beliefs (16%), latent tuberculosis infection beliefs (11%), and patient lifestyle and family concerns (10%).
CONCLUSION


Educational efforts addressing clinical research concerns and beliefs about medication and health, as well as study protocols that accommodate patient-related concerns (e.g. work, school, and lifestyle) might increase willingness to enter clinical trials. Findings from this evaluation can support development of communication and education materials for clinical trial sites at the beginning of a trial to allow study staff to address potential participant concerns during study screening.",2020,"Among 1305 patients with one or more reported reasons for nonparticipation, study staff recorded a total of 1886 individual reasons (reason count: median = 1/patient; range = 1-9) for why patients chose not to enroll, including grouped concerns about research (24% of 1886), work or school conflicts (20%), medication or health beliefs (16%), latent tuberculosis infection beliefs (11%), and patient lifestyle and family concerns (10%).
","['During 2001-2009, the Tuberculosis Trials Consortium conducted Study 26 (PREVENT TB), a randomized clinical trial at 26 sites in four countries, among persons with latent tuberculosis infection at high risk for tuberculosis disease progression, comparing 3\u2009months of directly observed once-weekly', 'Of the 7452 candidates screened in Brazil, Canada, Spain, and the United States, 3584 (48%) were not enrolled, because of ineligibility (41%), site decision (10%), or patient choice (49', '1305 patients with one or more reported reasons for nonparticipation, study staff recorded a total of 1886 individual reasons (reason count: median\u2009=\u20091/patient; range\u2009=\u20091-9) for why patients chose not to enroll, including grouped concerns about research (24% of 1886), work or school conflicts (20%), medication or health beliefs (16%), latent tuberculosis infection beliefs (11%), and patient lifestyle and family concerns (10']",['rifapentine plus isoniazid with 9\u2009months of self-administered daily isoniazid'],[],"[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1609538', 'cui_str': 'Latent Tuberculosis Infection'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",[],1305.0,0.201827,"Among 1305 patients with one or more reported reasons for nonparticipation, study staff recorded a total of 1886 individual reasons (reason count: median = 1/patient; range = 1-9) for why patients chose not to enroll, including grouped concerns about research (24% of 1886), work or school conflicts (20%), medication or health beliefs (16%), latent tuberculosis infection beliefs (11%), and patient lifestyle and family concerns (10%).
","[{'ForeName': 'Kimberley N Chapman', 'Initials': 'KNC', 'LastName': 'Hedges', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Andrey S', 'Initials': 'AS', 'LastName': 'Borisov', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jussi J', 'Initials': 'JJ', 'LastName': 'Saukkonen', 'Affiliation': 'School of Medicine, Boston University, Boston, MA, USA.'}, {'ForeName': 'Nigel A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Hecker', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Bozeman', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Dukes Hamilton', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kerrigan', 'Affiliation': 'School of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bessler', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Moreno-Martinez', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Arevalo', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Goldberg', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519885380']
720,29897562,"Post-chemoradiation volumetric response predicts survival in newly diagnosed glioblastoma treated with radiation, temozolomide, and bevacizumab or placebo.","Background


In the current study we used contrast-enhanced T1 subtraction maps to test whether early changes in enhancing tumor volume are prognostic for overall survival (OS) in newly diagnosed glioblastoma (GBM) patients treated with chemoradiation with or without bevacizumab (BV).
Methods


Seven hundred ninety-eight patients (404 BV and 394 placebo) with newly diagnosed GBM in the AVAglio trial (NCT00943826) had baseline MRI scans available, while 337 BV-treated and 269 placebo-treated patients had >4 MRI scans for response evaluation. The volume of contrast-enhancing tumor was quantified and used for subsequent analyses.
Results


A decrease in tumor volume during chemoradiation was associated with a longer OS in the placebo group (hazard ratio [HR] = 1.578, P < 0.0001) but not BV-treated group (HR = 1.135, P = 0.4889). Results showed a higher OS in patients on the placebo arm with a sustained decrease in tumor volume using a post-chemoradiation baseline (HR = 1.692, P = 0.0005), and a trend toward longer OS was seen in BV-treated patients (HR = 1.264, P = 0.0724). Multivariable Cox regression confirmed that sustained response or stable disease was prognostic for OS (HR = 0.7509, P = 0.0127) when accounting for age (P = 0.0002), KPS (P = 0.1516), postsurgical tumor volume (P < 0.0001), O6-methylguanine-DNA methyltransferase status (P < 0.0001), and treatment type (P = 0.7637) using the post-chemoradiation baseline.
Conclusions


The post-chemoradiation timepoint is a better baseline for evaluating efficacy in newly diagnosed GBM. Early progression during the maintenance phase is consequential in predicting OS, supporting the use of progression-free survival rates as a meaningful surrogate for GBM.",2018,"A decrease in tumor volume during chemoradiation was associated with a longer OS in the placebo group (hazard ratio [HR] = 1.578, P < 0.0001) but not BV-treated group (HR = 1.135, P = 0.4889).","['newly diagnosed glioblastoma (GBM) patients treated with chemoradiation with or without bevacizumab (BV', 'Methods\n\n\nSeven hundred ninety-eight patients (404 BV and 394 placebo) with newly diagnosed GBM in the AVAglio trial (NCT00943826) had baseline MRI scans available, while 337 BV-treated and 269 placebo-treated patients had >4 MRI scans for response evaluation']","['radiation, temozolomide, and bevacizumab or placebo', 'placebo']","['longer OS', 'postsurgical tumor volume', 'tumor volume', 'O6-methylguanine-DNA methyltransferase status', 'volume of contrast-enhancing tumor']","[{'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0917711', 'cui_str': 'MRI Scans'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0069225', 'cui_str': '6-methoxyguanine'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C4521687', 'cui_str': 'Methyltransferase (disposition)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",798.0,0.163251,"A decrease in tumor volume during chemoradiation was associated with a longer OS in the placebo group (hazard ratio [HR] = 1.578, P < 0.0001) but not BV-treated group (HR = 1.135, P = 0.4889).","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Abrey', 'Affiliation': 'F. Hoffman-La Roche, Ltd.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'F. Hoffman-La Roche, Ltd.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Aix-Marseille University, AP-HM, Service de Neuro-Oncologie, CHU Timone, Marseille, France.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Clinical Cooperation Unit Neuro-oncology, German Cancer Consortium, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Saran', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nishikawa', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Henriksson', 'Affiliation': 'Regional Cancer Center Stockholm, Stockholm, Sweden and Umeå University, Umeå, Sweden.'}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Mason', 'Affiliation': 'Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Harris', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Leu', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Davis C', 'Initials': 'DC', 'LastName': 'Woodworth', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Arnav', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Raymond', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Ararat', 'Initials': 'A', 'LastName': 'Chakhoyan', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Whitney B', 'Initials': 'WB', 'LastName': 'Pope', 'Affiliation': 'Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'UCLA Brain Research Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}]",Neuro-oncology,['10.1093/neuonc/noy064']
721,30686607,"Introduction of Physician-Nurse Bedside Rounding and Ward Task List to Improve Quality of Care in Gynaecology: Prospective, Single-Blinded, Pre- and Post-Intervention Study.","OBJECTIVE


This study sought to determine whether physician-nurse bedside rounds and ward task list improve quality of care as measured by patient satisfaction, earlier discharge, and reduced trainee interruptions.
METHODS


This prospective, single-blind, pre- and post-intervention study included patients admitted to the gynaecology ward at St. Michael's Hospital in Toronto, Ontario, involving a 6-week baseline, 6-week intervention, and 2-week second baseline phase. During the intervention phase, a chief resident and charge nurse rounded at the bedside simultaneously daily. Nurses recorded non-urgent issues on a ward task list. Patients completed a subset of the National Research Corporation Picker satisfaction questionnaire, discharge times were noted, and residents recorded pages (Canadian Task Force Classification II-2).
RESULTS


There were 89, 104, and 30 admissions during baseline care, intervention, and second baseline phases, respectively. Mean discharge time in the intervention phase was significantly earlier than baseline (11:18 am ± 1 hour 59 minutes vs. 12:37 pm ± 2 hours 37 minutes, P < 0.001), with early discharges doubling (69% vs. 36%, P < 0.001). Discharge times returned to baseline after the intervention (12:36 pm ± 2 hours 39 minutes). Intervention phase patients appreciated bedside care plans (86 of 94 patients, 92%), with improved National Research Corporation Picker responses, which diminished post-intervention. Paging interruptions were lower during the intervention phase compared with the baseline phase (1.0 ± 1.1 vs. 3.4 ± 2.1, P < 0.001), with non-urgent pages decreasing most (0.5 ± 0.8 vs. 3.0 ± 2.0, P < 0.001).
CONCLUSION


Combining physician-nurse bedside rounds and ward task list reduces trainee interruptions, positively affects patient satisfaction, and promotes early discharge. Following these initiatives, discharge time, patient satisfaction, and resident paging interruptions returned to baseline.",2019,"Paging interruptions were lower during the intervention phase compared with the baseline phase (1.0±1.1 vs. 3.4±2.1, P<0.001), with non-urgent pages decreasing most (0.5±0.8 vs. 3.0±2.0, P<0.001).
","[""patients admitted to the gynaecology ward at St. Michael's Hospital in Toronto, Ontario, involving a 6-week baseline, 6-week intervention, and 2-week second baseline phase""]",[],"['bedside care plans', 'National Research Corporation Picker satisfaction questionnaire, discharge times', 'Discharge times', 'Mean discharge time', 'discharge time, patient satisfaction, and resident paging interruptions', 'Paging interruptions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",[],"[{'cui': 'C2961279', 'cui_str': 'Bedside-Care'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0035168'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.0451009,"Paging interruptions were lower during the intervention phase compared with the baseline phase (1.0±1.1 vs. 3.4±2.1, P<0.001), with non-urgent pages decreasing most (0.5±0.8 vs. 3.0±2.0, P<0.001).
","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Shirreff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Mount Sinai Hospital, Toronto, ON. Electronic address: lindsay.shirreff@sinaihealthsystem.ca.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Husslein', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Guylaine G', 'Initials': 'GG', 'LastName': 'Lefebvre', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON.'}, {'ForeName': 'Eliane M', 'Initials': 'EM', 'LastName': 'Shore', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, St. Michael's Hospital, Toronto, ON.""}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.11.004']
722,31646257,Efficacy and safety of oral nifedipine with or without vaginal progesterone in the management of threatened preterm labor.,"Background


Preterm labor (PTL) is a serious emergency wherein robust management is imperative for achieving improved outcome.
Objective


To evaluate the efficacy and safety of nifedipine alone vs nifedipine with vaginal progesterone in managing threatened PTL.
Materials and Methods


This comparative study was carried out at the Pakistan Institute of Medical Sciences, Islamabad over a 2-year' period, from September, 2013 to August, 2015. The study included 276 patients with threatened PTL. Half of them were allocated to nifedipine alone group whereas the remainder half to the additional progesterone group. In nifedipine alone group (group A), all the patients were given 20░mg of rapid release nifedipine orally. If uterine contraction continued, a 10░mg dose was repeated every 20░min with a maximum of 40░mg within the first hour. After completing the first hour, 20░mg was given every 4-6 hr for 72░hr. In the additional vaginal progesterone group (group B), following successful tocolysis with nifedipine, additional - maintenance tocolysis was ensured with vaginal progesterone 200░mg daily.
Results


Successful acute tocolysis was achieved with nifedipine among 86.23% patients. Mean pregnancy prolongation was 11.13░±░5.08 days in group A while 29.73░±░3.10 days in group B. (p░≤░0.001).
Conclusion


Acute tocolytic therapy with nifedipine was successful in the majority of our patients. The additional daily use of vaginal progesterone suppositories resulted in significant prolongation of pregnancy as well as reduction in the rate of low birth weight and neonatal ICU admissions.",2019,"Mean pregnancy prolongation was 11.13░±░5.08 days in group A while 29.73░±░3.10 days in group B. (p░≤░0.001).
","[""Pakistan Institute of Medical Sciences, Islamabad over a 2-year' period, from September, 2013 to August, 2015"", 'threatened preterm labor', '276 patients with threatened PTL']","['vaginal progesterone', 'nifedipine alone vs nifedipine with vaginal progesterone', '\n\n\nPreterm labor (PTL', 'nifedipine, additional - maintenance tocolysis was ensured with vaginal progesterone 200░mg daily', 'vaginal progesterone suppositories', 'oral nifedipine with or without vaginal progesterone', 'nifedipine', 'nifedipine orally']","['rate of low birth weight and neonatal ICU admissions', 'efficacy and safety', 'Successful acute tocolysis', 'Efficacy and safety', 'Mean pregnancy prolongation']","[{'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0040348', 'cui_str': 'Tocolytic Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0040348', 'cui_str': 'Tocolytic Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",276.0,0.0293298,"Mean pregnancy prolongation was 11.13░±░5.08 days in group A while 29.73░±░3.10 days in group B. (p░≤░0.001).
","[{'ForeName': 'Bushra', 'Initials': 'B', 'LastName': 'Ashraf', 'Affiliation': 'Department of Obstetrics and Gynecology, Pakistan Institute of Medical Sciences (PIMS) Islamabad Pakistan.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i9.5098']
723,30643866,Frozen thawed embryo transfer cycles; A comparison of pregnancy outcomes with and without prior pituitary suppression by GnRH agonists: An RCT.,"Background


To perform an in-vitro fertilization cycle, pretreatment with gonadotropin-releasing hormone (GnRH) agonist is widely used as a part of controlled ovarian hyper-stimulation protocols to prevent endogenous luteinizing hormone surge and spontaneous ovulation. GnRH agonist pretreatment is relatively costly and there is a risk of hypo estrogenic side effect. It would also lengthen the preparation period until pituitary desensitization occurs.
Objective


Our study is aimed at evaluating the pregnancy outcome rate of frozen thawed embryo transfer with and without GnRH agonists pretreatment.
Materials and Methods


Women with documented infertility who were candidate for frozen thawed embryo transfer were recruited and randomly assigned to two groups. In group A (n=100), patients received GnRH agonist, Buserelin, to induce pituitary desensitization prior to endometrial preparation and embryo transfer. Individuals in group B (n=100) received steroid manipulation without prior down-regulation of the pituitary. Chemical pregnancy, implantation rate, clinical pregnancy and ongoing pregnancy were measured and statistically compared between the two groups.
Results


None of the outcome measures including clinical and chemical pregnancy rates, implantation rate, and ongoing pregnancy rate showed significant difference between the two groups. Similarly, the rate of miscarriage did not vary between the two groups.
Conclusion


In this study, we found that removing the GnRH agonists pretreatment from the programmed cycles did not negatively influence the pregnancy outcome or implantation rate. Moreover, it will cause a considerable reduction in cost of assisted reproductive technology as well as adverse effects related to GnRH agonists, while having a favorable implantation and pregnancy outcomes.",2018,"None of the outcome measures including clinical and chemical pregnancy rates, implantation rate, and ongoing pregnancy rate showed significant difference between the two groups.",['Materials and Methods\n\n\nWomen with documented infertility who were candidate for frozen thawed embryo transfer'],"['steroid manipulation without prior down-regulation of the pituitary', 'gonadotropin-releasing hormone (GnRH) agonist', 'GnRH agonist, Buserelin, to induce pituitary desensitization prior to endometrial preparation and embryo transfer', 'frozen thawed embryo transfer with and without GnRH agonists pretreatment']","['clinical and chemical pregnancy rates, implantation rate, and ongoing pregnancy rate', 'pregnancy outcome or implantation rate', 'Chemical pregnancy, implantation rate, clinical pregnancy and ongoing pregnancy', 'rate of miscarriage']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0006456', 'cui_str': 'Buserelin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0556520', 'cui_str': 'Desensitization (Psychology)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",,0.0742689,"None of the outcome measures including clinical and chemical pregnancy rates, implantation rate, and ongoing pregnancy rate showed significant difference between the two groups.","[{'ForeName': 'Alamtaj', 'Initials': 'A', 'LastName': 'Samsami', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Chitsazi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Namazi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
724,30624767,Comparison of Cognitive Impairments After Intensive Care Unit Sedation Using Dexmedetomidine and Propofol Among Older Patients.,"Despite the high prevalence of cognitive impairment among older adults, little is known about the association of the selection of dexmedetomidine and propofol on cognitive functions of patients after a critical illness. Patients aged ≥70 years who received intensive care unit (ICU) care from Cangzhou Central Hospital between 2013 and 2016 were enrolled and randomized into a dexmedetomidine group and a propofol group with matched demographic and clinical characteristics. At discharge from the ICU and 4 weeks later, the cognitive status of patients was assessed and compared using the Montreal Cognitive Assessment system. There were 164 patients included in the dexmedetomidine group and 159 patients in the propofol group. No significant difference was observed between the 2 groups in terms of age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications. Further, patients from the 2 groups at ICU discharge did not demonstrate significant difference on the Montreal Cognitive Assessment component scores, which showed significant differences between the 2 groups 4 weeks later (P < .05). Moreover, dexmedetomidine and propofol showed different levels of impacts on the cognitive function of patients discharged from the postanesthesia care unit, neurological ICU, and medical ICU. This study demonstrated that patients discharged from the ICU who received propofol for sedation showed less impairment on the cognitive functions when compared with patients who received dexmedetomidine during ICU care 4 weeks after discharge. Despite some limitations, this study provides insights to the decision-making process in the selection of appropriate sedation strategy, especially for the elderly patients.",2019,"No significant difference was observed between the 2 groups in terms of age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications.","['Older Patients', 'older adults', 'Patients aged ≥70 years who received intensive care unit (ICU) care from Cangzhou Central Hospital between 2013 and 2016', '164 patients included in the dexmedetomidine group and 159 patients in the propofol group', 'elderly patients']","['dexmedetomidine', 'dexmedetomidine and propofol', 'propofol', 'Dexmedetomidine and Propofol']","['cognitive functions', 'cognitive function', 'age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications', 'Cognitive Impairments', 'Montreal Cognitive Assessment component scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C3496286'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.015223,"No significant difference was observed between the 2 groups in terms of age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications.","[{'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Cangzhou Central Hospital, Hebei, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Cangzhou Prison, Hebei, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Internal Medicine, Cangzhou Central Hospital, Hebei, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Internal Medicine, Cangzhou People's Hospital, China.""}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Internal Medicine, Cangzhou Central Hospital, Hebei, China.'}]",Journal of clinical pharmacology,['10.1002/jcph.1372']
725,31621610,Effect of light on blinking in patients with idiopathic isolated blepharospasm.,"OBJECTIVE


Melanopsin may be involved in the pathophysiology of photophobia in idiopathic isolated blepharospasm. We assessed the efficacy of blocking wavelengths of melanopsin absorption to reduce blinking in blepharospasm as a possible surrogate for photophobia.
METHODS


Twenty-one participants (11 blepharospasm and 10 healthy controls) were studied. There were three sessions: (1) a baseline condition to measure the blink rate (BR) without intervention; (2) two conditions where the participants received intermittent light stimuli with high or low intensity without wearing study lenses; (3) four conditions in which the participants received intermittent light stimuli with high intensity while wearing one of four different lenses: tinted lenses with neutral gray or FL-41, or coated lenses that block 480-nm or 590-nm wavelength. The primary outcome measure was the BR.
RESULTS


The blepharospasm group blinked more frequently than controls in dim room conditions. Patients reported greater photosensitivity compared to controls based on the questionnaire and exhibited a higher BR with intermittent light stimuli. The BR decreased for both groups when using 480-nm and 590-nm blocking lenses. In the patients, 480-nm and 590-nm blocking lenses reduced the mean BR by 9.6 blink/min and 10.3 blink/min, respectively, while in the control group, the mean BR decreased by 4.4 blink/min and 4.3 blink/min, respectively.
CONCLUSIONS


Blepharospasm patients had increased BR with light stimuli which decreased with 590-nm and 480-nm blocking lenses. The 480-nm- and 590-nm- coated lenses might have therapeutic potential in treating photophobia although BR does not appear to be an optimal biomarker for photophobia.",2019,"CONCLUSIONS


Blepharospasm patients had increased BR with light stimuli which decreased with 590-nm and 480-nm blocking lenses.","['patients with idiopathic isolated blepharospasm', 'Twenty-one participants (11 blepharospasm and 10 healthy controls']","['intermittent light stimuli with high or low intensity without wearing study lenses; (3) four conditions in which the participants received intermittent light stimuli with high intensity while wearing one of four different lenses: tinted lenses with neutral gray or FL-41, or coated lenses that block 480-nm or 590-nm wavelength']","['mean BR', 'blink rate (BR', 'BR with light stimuli', 'photosensitivity', 'BR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0393604', 'cui_str': 'Isolated blepharospasm (disorder)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0449819', 'cui_str': 'Wavelength (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0349506', 'cui_str': 'Photosensitization'}]",21.0,0.0259612,"CONCLUSIONS


Blepharospasm patients had increased BR with light stimuli which decreased with 590-nm and 480-nm blocking lenses.","[{'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology & Institute of Neurology, RuiJin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China; Laboratory of Neurodegenerative Diseases & Key Laboratory of Stem Cell Biology, Institute of Health Science, Shanghai Institutes for Biological Sciences (SIBS), Chinese Academy of Sciences (CAS) & Shanghai Jiao Tong University School of Medicine, Shanghai, China; Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA. Electronic address: wyw11380@rjh.com.cn.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Cho', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA. Electronic address: bellehyunjoo@gmail.com.'}, {'ForeName': 'Pattamon', 'Initials': 'P', 'LastName': 'Panyakaew', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA; Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand. Electronic address: ppanyakaew@yahoo.com.'}, {'ForeName': 'Charulata Sankhla', 'Initials': 'CS', 'LastName': 'Savant', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA; PD Hinduja National Hospital,V Savakar Marg, Mahim. Mumbai,India. Electronic address: charusankhla@gmail.com.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical Trials Unit, Office of the Clinical Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA. Electronic address: wutao69@163.com.'}, {'ForeName': 'Nguyet', 'Initials': 'N', 'LastName': 'Dang', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA. Electronic address: DangN@ninds.nih.gov.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA. Electronic address: hallettm@ninds.nih.gov.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.09.010']
726,31655622,"Early treatment with ambrisentan of mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis: a randomized, controlled, double-blind, parallel group study (EDITA study).","OBJECTIVE


The objective of this randomized, placebo-controlled, double-blind, parallel group, trial was to assess the effect of ambrisentan on mean pulmonary arterial pressure (mPAP) in patients with systemic sclerosis (SSc) and mildly elevated pulmonary hypertension (PH).
METHODS


Thirty-eight SSc patients with mildly elevated mPAP at rest between 21 and 24 mmHg and/or > 30 mmHg during low-dose exercise were randomly assigned to treatment with either ambrisentan 5-10 mg/day or placebo. Right heart catheterization and further clinical parameters were assessed at baseline and after 6 months. The primary endpoint was the difference of mPAP change at rest between groups.
RESULTS


After 6 months, the two groups did not differ in the primary endpoint (ambrisentan mPAP - 1 ± 6.4 mmHg vs. placebo - 0.73 ± 3.59 mmHg at rest, p = 0.884). However, three patients from the placebo group but none of the ambrisentan group progressed to SSc-associated pulmonary arterial hypertension. Furthermore, ambrisentan treatment showed significant improvements in the secondary endpoints cardiac index (CI) and pulmonary vascular resistance (PVR) at rest (CI 0.36 ± 0.66 l/min/m 2  vs. - 0.31 ± 0.71 l/min/m 2 , p = 0.010; PVR - 0.70 ± 0.78 WU vs. 0.01 ± 0.71 WU, p = 0.012) and during exercise (CI 0.7 ± 0.81 l/min/m 2  vs. - 0.45 ± 1.36 l/min/m 2 , p = 0.015; PVR - 0.84 ± 0.48 WU vs. - 0.0032 ± 0.34 WU, p < 0.0001).
CONCLUSION


This is the first randomized, double-blind, placebo-controlled study testing the effect of ambrisentan in patients with mildly elevated mPAP and/or exercise PH. The primary endpoint change in mPAP did only tendentially improve in the ambrisentan group, but the significant improvement of other hemodynamic parameters points to a possible benefit of ambrisentan and will be helpful to design future trials.
TRIAL REGISTRATION


www.ClinicalTrials.gov, unique identifier NCT: NCT02290613 , registered 14 th  of November 2014.",2019,"After 6 months, the two groups did not differ in the primary endpoint (ambrisentan mPAP - 1 ± 6.4 mmHg vs. placebo - 0.73 ± 3.59 mmHg at rest, p = 0.884).","['Thirty-eight SSc patients with mildly elevated mPAP at rest between 21 and 24\u2009mmHg', 'patients with mildly elevated mPAP and/or exercise PH', 'patients with systemic sclerosis (SSc) and mildly elevated pulmonary hypertension (PH', 'mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis']","['placebo', 'ambrisentan', 'ambrisentan 5-10\u2009mg/day or placebo']","['secondary endpoints cardiac index (CI) and pulmonary vascular resistance (PVR', 'mean pulmonary arterial pressure (mPAP', 'mPAP', 'SSc-associated pulmonary arterial hypertension', 'mPAP change']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.759956,"After 6 months, the two groups did not differ in the primary endpoint (ambrisentan mPAP - 1 ± 6.4 mmHg vs. placebo - 0.73 ± 3.59 mmHg at rest, p = 0.884).","[{'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Marra', 'Affiliation': 'IRCCS SDN Research Institute, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Benjamin', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Eichstaedt', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Blank', 'Affiliation': 'Department of Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bossone', 'Affiliation': 'Division of Cardiology, U.O.C. Rehabilitazione Cardiovascolare, A Cardarelli, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cittadini', 'Affiliation': 'Department of Translational Medical Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Coghlan', 'Affiliation': 'Cardiology Department, Royal Free Hospital, London, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Centre of Rheumatology, Royal Free Hospital, London, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Egenlauf', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Department of Human Genetics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Satenik', 'Initials': 'S', 'LastName': 'Harutyunova', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Xanthouli', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Hanns-Martin', 'Initials': 'HM', 'LastName': 'Lorenz', 'Affiliation': ''}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Grünig', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany. ekkehard.gruenig@med.uni-heidelberg.de.'}]",Arthritis research & therapy,['10.1186/s13075-019-1981-0']
727,30496532,"Examining the external validity of the CRUZA study, a randomized trial to promote implementation of evidence-based cancer control programs by faith-based organizations.","The CRUZA trial tested the efficacy of an organizational-level intervention to increase capacity among Catholic parishes to implement evidence-based interventions (EBIs) for cancer control. This paper examines the external generalizability of the CRUZA study findings by comparing characteristics of parishes that agreed to participate in the intervention trial versus those that declined participation. Sixty-five Roman Catholic parishes that offered Spanish-language mass in Massachusetts were invited to complete a four-part survey assessing organization-level characteristics that, based on the Consolidated Framework for Implementation Research (CFIR), may be associated with EBI implementation. Forty-nine parishes (75%) completed the survey and were invited to participate in the CRUZA trial, which randomized parishes to either a ""capacity enhancement intervention"" or a ""standard dissemination"" group. Of these 49 parishes, 31 (63%) agreed to participate in the trial, whereas 18 parishes (37%) declined participation. Parishes that participated in the CRUZA intervention trial were similar to those that did not participate with respect to ""inner organizational setting"" characteristics of the CFIR, including innovation and values fit, implementation climate, and organizational culture. Change commitment, a submeasure of organizational readiness that reflects the shared resolve of organizational members to implement an innovation, was significantly higher among the participating parishes (mean = 3.93, SD = 1.08) as compared to nonparticipating parishes (mean = 3.27, SD = 1.08) (Z = -2.16, p = .03). Parishes that agreed to participate in the CRUZA intervention trial were similar to those that declined participation with regard to organizational characteristics that may predict implementation of EBIs. Pragmatic tools to assess external generalizability in community-based implementation trials and to promote readiness among faith-based organizations to implement EBIs are needed to enhance the reach and impact of public health research. Clinical Trial information: The CRUZA trial identifier number with clinicaltrials.gov is NCT01740219.",2020,The CRUZA trial tested the efficacy of an organizational-level intervention to increase capacity among Catholic parishes to implement evidence-based interventions (EBIs) for cancer control.,"['Forty-nine parishes (75%) completed the survey and were invited to participate in the CRUZA trial', 'Sixty-five Roman Catholic parishes that offered Spanish-language mass in Massachusetts']","['organizational-level intervention', 'capacity enhancement intervention"" or a ""standard dissemination"" group']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholics'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],,0.0538825,The CRUZA trial tested the efficacy of an organizational-level intervention to increase capacity among Catholic parishes to implement evidence-based interventions (EBIs) for cancer control.,"[{'ForeName': 'Jennifer Dacey', 'Initials': 'JD', 'LastName': 'Allen', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Kephart', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Tom', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Leyva', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Hosffman', 'Initials': 'H', 'LastName': 'Ospino', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Adolfo G', 'Initials': 'AG', 'LastName': 'Cuevas', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}]",Translational behavioral medicine,['10.1093/tbm/iby099']
728,30637727,Anatomical site differences of sodium lauryl sulfate-induced irritation: randomized controlled trial.,"BACKGROUND


Sodium lauryl sulfate (SLS)-induced contact dermatitis is a commonly used model for testing the effects of different topical formulations. According to the guidelines, the volar forearms are the preferred testing site; however, other anatomical locations have been used in previous research, particularly the upper back as the clinically used site for testing different antigens.
OBJECTIVES


To investigate the existence of anatomical variations of the skin response to irritation and its effects on the response to treatment.
METHODS


Irritation was induced with SLS on symmetrical sites on both forearms and sides of the upper back with additional sites exposed to water as controls. Half of the sites were treated with emollient cream while the other half were left untreated. Irritation was assessed using bioengineering methods and clinical scoring. The trial was registered at ClinicalTrials.gov as NCT03231813.
RESULTS


Upper back skin showed higher reactivity to irritants with stronger barrier disruption (measured by Tewameter ®  , 80·2 ± 18·3 vs. 48·0 ± 24·2 g m -2   h -1  ), more pronounced erythema (measured by Mexameter ®  , 186·5 ± 88·4 vs. 92·1 ± 58·2 arbitrary units) and dryness (measured by Corneometer ®  , -28·6 ± 14·5 vs. 2·7 ± 16·9 arbitrary units). Skin recovery rates were also influenced by anatomical location with the upper back showing faster recovery (316·7 ± 223·1 vs. 156·2 ± 198·5). Treatment did not lead to improvement in measured parameters, regardless of anatomical location.
CONCLUSIONS


The skin's reaction to irritant and recovery was dependent on anatomical location. The location where testing was conducted should always be reported, as treatments tested across different locations could not be directly compared with each other.",2019,"RESULTS


Upper back skin showed higher reactivity to irritants with stronger barrier disruption (measured by Tewameter ®  , 80·2 ± ",['24·2'],"['sodium lauryl sulfate-induced irritation', 'SLS', 'emollient cream']","['Skin recovery rates', 'pronounced erythema', 'Irritation']",[],"[{'cui': 'C0037506', 'cui_str': 'sodium lauryl sulfate'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}]",,0.0457905,"RESULTS


Upper back skin showed higher reactivity to irritants with stronger barrier disruption (measured by Tewameter ®  , 80·2 ± ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Leskur', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bukić', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Petrić', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zekan', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rušić', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Šešelja Perišin', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Petrić', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stipić', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Puizina-Ivić', 'Affiliation': 'Department of Dermatovenerology, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Modun', 'Affiliation': 'Department of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}]",The British journal of dermatology,['10.1111/bjd.17633']
729,31589323,Combination Lorcaserin and Nicotine Patch for Smoking Cessation Without Weight Gain.,"INTRODUCTION


This study explored the efficacy of combination lorcaserin and nicotine patch for smoking cessation treatment and prevention of postsmoking cessation weight gain.
METHODS


We conducted a trial in which 61 adult daily smokers were asked to quit smoking using a combination of lorcaserin and nicotine patch. During the first 2 weeks of treatment prior to the quit day, participants were randomized to receive either lorcaserin (10 mg twice daily) plus nicotine patch (21 mg) or placebo plus nicotine patch (21 mg). Following this 2-week period, participants received both medications for 12 weeks. Outcomes included 4-week continuous smoking abstinence at the end of treatment (weeks 7-10 postquit attempt), weight change, ad libitum smoking, withdrawal symptoms, and ratings of cigarette reward.
RESULTS


Biochemically confirmed continuous smoking abstinence from 7 to 10 weeks postquit attempt was 31.1% (90% confidence interval, 21.4%-40.8%). Participants who quit smoking showed no weight gain; in fact, mean weight change was minus 0.16 kg (SD = 3.27) over the study period. There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen. During the prequit randomization period, lorcaserin versus placebo reduced the impact of smoking to relieve craving for cigarettes as well as the sensory enjoyment of smoking (p = .005). Adherence and tolerability to lorcaserin and nicotine patch was good.
CONCLUSIONS


The combination of lorcaserin and nicotine patch was well tolerated, associated with a relatively high smoking abstinence rate, and effectively prevented weight gain associated with quitting smoking.
IMPLICATIONS


This report provides an important contribution to the literature because it details evidence of a medication combination-lorcaserin and nicotine-that is effective for smoking cessation and for ameliorating weight gain associated with smoking cessation. For many smokers, postcessation weight gain is a major obstacle to quitting, and this medication combination provides a suitable treatment option for these smokers.
CLINICAL TRIAL REGISTRATION


NCT02906644.",2020,There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen.,"['Smoking Cessation Without Weight Gain', '61 adult daily smokers']","['lorcaserin versus placebo', 'lorcaserin', 'placebo plus nicotine patch', 'lorcaserin and nicotine patch', 'combination lorcaserin and nicotine patch', 'quit smoking using a combination of lorcaserin and nicotine patch', 'Combination Lorcaserin and Nicotine Patch', 'nicotine patch']","['sensory enjoyment of smoking and successful quit outcome', 'mean weight change', '4-week continuous smoking abstinence', 'weight change, ad libitum smoking, withdrawal symptoms, and ratings of cigarette reward', 'Adherence and tolerability', 'continuous smoking abstinence', 'weight gain']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",61.0,0.0300442,There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen.,"[{'ForeName': 'Jed E', 'Initials': 'JE', 'LastName': 'Rose', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Duke University, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz149']
730,30788263,The evaluation of a fourth-generation multi-theory model (MTM) based intervention to initiate and sustain physical activity.,"Background:  The United States Department of Health and Human Services (USDHHS)recommends that adults achieve 150 minutes per week of moderate-intensity aerobic activity.Most African American women do not meet these guidelines. The purpose of this study was to determine the efficacy of an intervention based on the fourth generation, multi-theory model (MTM) of health behavior change for initiating and sustaining physical activity among African American women when compared to a first generation, knowledge-based intervention.  Methods:  The randomized controlled trial (RCT) utilized a pre-test, post-test and 6-week followup evaluation with an experimental (n=25) group and a comparison group (n=23). Process evaluation for satisfaction and program fidelity was conducted along with impact evaluation for changes in MTM constructs, intent to initiate and sustain physical activity, minutes of physical activity, body mass index (BMI), waist circumference and blood pressure in hypertensives.  Results: The MTM-based intervention proved significantly efficacious in increasing the minutes of physical activity from pre-test mean of 37 minutes to 172 minutes at follow-up (mean difference135.08 minutes, 95% CI: 106.04 to 164.13, P<0.0001), reducing waist circumference from pretest mean of 39 inches to 38 inches at follow-up (mean difference -1.12 inches, 95% CI: -1.70 to-0.545, P<0.001) and modifying the MTM construct of changes in physical environment from a mean of 7 units at pre-test to 9 units at follow-up (mean difference 2.08 units, 95% CI: 0.73 to 3.43, P<0.004) when compared to the knowledge-based intervention over time.  Conclusion:  There were directional improvements in the mean scores for most of the study variables over time for the MTM intervention group and statistically significant improvement in minutes of physical activity and waist circumference.",2019,There were directional improvements in the mean scores for most of the study variables over time for the MTM intervention group and statistically significant improvement in minutes of physical activity and waist circumference.,"['African American women', 'United States Department of Health and Human Services']",['multi-theory model (MTM'],"['minutes of physical activity and waist circumference', 'minutes of physical activity', 'waist circumference', 'physical activity, body mass index (BMI), waist circumference and blood pressure in hypertensives']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041711', 'cui_str': 'United States Department of Health and Human Services'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]",,0.0471597,There were directional improvements in the mean scores for most of the study variables over time for the MTM intervention group and statistically significant improvement in minutes of physical activity and waist circumference.,"[{'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Hayes', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, Jackson, MS, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, Jackson, MS, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shahbazi', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, Jackson, MS, USA.'}, {'ForeName': 'Jung Hye', 'Initials': 'JH', 'LastName': 'Sung', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, Jackson, MS, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Bennett', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, Jackson, MS, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Reese-Smith', 'Affiliation': 'Department of Psychology, Jackson State University, Jackson, MS, USA.'}]",Health promotion perspectives,['10.15171/hpp.2019.02']
731,32407583,Proprioceptive neuromuscular facilitation improves pain and descending mechanics among elderly with knee osteoarthritis.,"PURPOSE


Knee osteoarthritis (KOA) is a common disease that causes pain and limits functionality in the elderly during daily activities, especially during stair descent. Proprioceptive neuromuscular facilitation (PNF) practices promote multiple-plane joint movements, which relieve pain and increase joint range of motion (ROM). This study aims to examine the effects of a 12-week PNF intervention on pain relief, passive and active joint ROM, external knee adduction moment (KAM), and hip adduction moment (HAM) in the elderly with KOA during stair descent.
MATERIALS AND METHODS


Seventy-six elderly who were diagnosed with KOA were assessed for eligibility and, 36 of them met the inclusive criteria, were randomly divided into two groups: the twelve-week PNF intervention group and the control group. Pain score was measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Passive joint ROM was measured using a goniometer. Active joint ROM, KAM, and HAM during stair descent were measured using a motion analysis system with a force platform. All the data were recorded at weeks 0, 6, and 12.
RESULTS


Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
PERSPECTIVE


Proprioceptive neuromuscular facilitation intervention is a successful method to relieve symptoms of KOA. It relieves pain without increasing KAM, enhances passive ROM, increases active knee flexion ROM, and increases HAM during stair descent in the elderly with KOA.",2020,"Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
","['Seventy-six elderly who were diagnosed with KOA were assessed for eligibility and, 36 of them met the inclusive criteria', 'elderly with KOA during stair descent', 'Elderly with Knee Osteoarthritis']","['Proprioceptive neuromuscular facilitation (PNF) practices', 'Proprioceptive neuromuscular facilitation', 'PNF', 'PNF intervention']","['minimum knee flexion angle, and increased HAM during stair descent', 'Pain score', 'Passive joint ROM', 'pain score; increased passive hip, knee, and ankle ROM', 'HAM', 'pain and increase joint range of motion (ROM', 'Active joint ROM, KAM, and HAM during stair descent', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC', 'pain relief, passive and active joint ROM, external knee adduction moment (KAM) and hip adduction moment (HAM', 'active knee flexion ROM']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205101', 'cui_str': 'External'}]",76.0,0.023522,"Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
","[{'ForeName': 'Qipeng', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Shandong Sport University, Jinan, China.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Beijing Sport University, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Shandong Institute of Sport Science, Jinan, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Shandong Institute of Sport Science, Jinan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Georgia Southern University, Statesboro, GA, USA.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13709']
732,31699436,Postoperative pain control modalities for pectus excavatum repair: A prospective observational study of cryoablation compared to results of a randomized trial of epidural vs patient-controlled analgesia.,"BACKGROUND


Pain following bar placement for pectus excavatum is the dominant factor post-operatively and determines length of stay (LOS). We recently adopted intercostal cryoablation as our preferred method of pain control following minimally invasive pectus excavatum repair. We compared the outcomes of cryoablation to results of a recently concluded trial of epidural (EPI) and patient-controlled analgesia (PCA) protocols.
METHODS


We conducted a prospective observational study of patients undergoing bar placement for pectus excavatum using intercostal cryoablation. Results are reported and compared with those of a randomized trial comparing EPI with PCA. Comparisons of medians were performed using Kruskal-Wallis H tests with alpha 0.05.
RESULTS


Thirty-five patients were treated with cryoablation compared to 32 epidural and 33 PCA patients from the trial. Cryoablation was associated with longer operating time (101 min, versus 58 and 57 min for epidural and PCA groups, p < 0.01), resulted in less time to pain control with oral medication (21 h, versus 72 and 67 h, p < 0.01), and decreased LOS (1 day, versus 4.3 and 4.2 days, p < 0.01).
CONCLUSION


Intercostal cryoablation during minimally invasive pectus excavatum repair reduces LOS and perioperative opioid consumption compared with both EPI and PCA.
LEVEL OF EVIDENCE


II.",2020,"Cryoablation was associated with longer operating time (101 min, versus 58 and 57 min for epidural and PCA groups, p < 0.01), resulted in less time to pain control with oral medication (21 h, versus 72 and 67 h, p < 0.01), and decreased LOS (1 day, versus 4.3 and 4.2 days, p < 0.01).
","['Thirty-five patients were treated with cryoablation compared to 32 epidural and 33 PCA patients from the trial', 'patients undergoing bar placement for pectus excavatum using intercostal cryoablation', 'pectus excavatum repair']","['epidural (EPI) and patient-controlled analgesia (PCA', 'Postoperative pain control modalities', 'Intercostal cryoablation', 'epidural vs patient-controlled analgesia']","['time to pain control with oral medication', 'LOS', 'LOS and perioperative opioid consumption', 'longer operating time']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0016842', 'cui_str': 'Pectus Excavatum'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",32.0,0.0936581,"Cryoablation was associated with longer operating time (101 min, versus 58 and 57 min for epidural and PCA groups, p < 0.01), resulted in less time to pain control with oral medication (21 h, versus 72 and 67 h, p < 0.01), and decreased LOS (1 day, versus 4.3 and 4.2 days, p < 0.01).
","[{'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Dekonenko', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Dorman', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Duran', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Juang', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Aguayo', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Fraser', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Tolulope A', 'Initials': 'TA', 'LastName': 'Oyetunji', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Snyder', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Holcomb', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Millspaugh', 'Affiliation': ""Department of Anesthesiology, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'St Peter', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO. Electronic address: sspeter@cmh.edu.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.09.021']
733,30664111,Effects of Combined Surfaces vs. Single-Surface Plyometric Training on Soccer Players' Physical Fitness.,"Ramirez-Campillo, R, Álvarez, C, García-Pinillos, F, García-Ramos, A, Loturco, I, Chaabene, H, and Granacher, U. Effects of combined surfaces vs. single-surface plyometric training on soccer players' physical fitness. J Strength Cond Res 34(9): 2644-2653, 2020-The aim of this study was to compare the effects of a 8-week plyometric jump training (PJT) performed on different surfaces (grass, land-dirt, sand, wood, gym mat, and tartan-track) vs. a single-surface PJT (grass) on components of physical fitness (muscle power, speed, and change-of-direction speed [CODS] tasks) and sport-specific performance (i.e., maximal kicking velocity [MKV]) in male soccer players aged 11-14 years. Athletes were randomly assigned to a combined surfaces PJT (PJTc, n = 8), a single-surface PJT (PJTs, n = 8), or an active control (CON, n = 7). Although the PJT group trained on grass, the PJTc trained on 6 different surfaces and equally distributed the total jump volume according to the surface. Pre-post tests were conducted on grass. Significant main effects of time were observed for the countermovement jump, the standing-long-jump, the 20-cm drop jump, 30-m sprint time, CODS, and MKV (all p < 0.001; d = 0.53-0.87). Group × time interactions were identified for all jump tests, MKV, 30-m sprint time, and CODS (all p < 0.001; d = 0.58-0.71) in favor of PJTc. No significant pre-post changes were observed in the CON (all p > 0.05; d = 0.07-0.1). In conclusion, PJT is effective in improving physical fitness in young soccer players when conducted in combination with regular soccer training. Although general fitness testing and PJTs were performed on grass, larger physical fitness improvements were found after PJTc. Thus, PJTc is recommended, as it provides a better overload stimulus compared with more conventional training overload (e.g., increase in training volume or intensity). Future studies still have to address the underlying physiological adaptations after PJTc.",2020,"Significant main effects of time were observed for the countermovement jump, the standing-long-jump, the 20-cm drop jump, 30-m sprint time, CODS, and MKV (all p < 0.001; d = 0.53-0.87).","['male soccer players aged 11-14 years', 'young soccer players', ""Soccer Players' Physical Fitness"", ""soccer players' physical fitness""]","['Combined Surfaces vs. Single-Surface Plyometric Training', 'J Strength Cond Res XX(X', '8-week plyometric jump training (PJT) performed on different surfaces (grass, land-dirt, sand, wood, gym mat, and tartan-track) vs. a single-surface PJT (grass', 'combined surfaces vs. single-surface plyometric training', 'combined surfaces PJT', 'PJT']","['physical fitness', 'physical fitness (muscle power, speed, and change-of-direction speed [CODS] tasks) and sport-specific performance (i.e., maximal kicking velocity [MKV', 'MKV, 30-m sprint time, and CODS', 'countermovement jump, the standing-long-jump, the 20-cm drop jump, 30-m sprint time, CODS, and MKV']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018210', 'cui_str': 'Grasses'}, {'cui': 'C1563093', 'cui_str': 'Distal intermedial ridge of tibia'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]",,0.0148782,"Significant main effects of time were observed for the countermovement jump, the standing-long-jump, the 20-cm drop jump, 30-m sprint time, CODS, and MKV (all p < 0.001; d = 0.53-0.87).","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Laboratory of Human Performance, Research Nucleus in Health, Physical Activity and Sport, Quality of Life and Wellness Research Group, Department of Physical Activity Sciences, Universidad de Los Lagos (University of Los Lagos), Osorno, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Álvarez', 'Affiliation': 'Laboratory of Human Performance, Research Nucleus in Health, Physical Activity and Sport, Quality of Life and Wellness Research Group, Department of Physical Activity Sciences, Universidad de Los Lagos (University of Los Lagos), Osorno, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García-Pinillos', 'Affiliation': 'Department of Physical Education, Sports and Recreation, Universidad de La Frontera (University of La Frontera), Temuco, Chile.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'Nucleus of High Performance in Sport-NAR, São Paulo, Brazil.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002929']
734,30664607,Nursing Students' Knowledge of the Nurse's Role in the Management of Dysphagia.,"PURPOSE


The purpose of this study was to evaluate nursing students' knowledge of the nurse's role in the interprofessional management of dysphagia.
DESIGN


A quasi-experimental, pretest-posttest educational intervention was used in this study.
METHODS


Thirty-eight pretest and 37 posttest undergraduate nursing students participated. An addendum to the original study assessed knowledge retention in a separate group of nursing students who had received a similar educational intervention 1.5 years prior.
FINDINGS


Statistically significant changes were found between pretests and posttests. The knowledge retention group performed more poorly in some areas, suggesting that initial instruction was not reinforced beyond the novice level.
CONCLUSIONS


Educating nursing students about the nurse's role in the management of dysphagia will increase their knowledge, but this knowledge must be reinforced for integration into clinical practice. More research is needed to determine what education nursing students receive on dysphagia and what the role of the nurse is in the management of dysphagia.
CLINICAL RELEVANCE


Dysphagia negatively impacts clinical and rehabilitation outcomes. Because nurses may lack sufficient training in the management of dysphagia, healthcare organizations should offer such training to new hires and then periodically thereafter. Likewise, practicing nurses who serve as preceptors should be prepared to train nursing students and new nurses how to safely manage dysphagia.",2020,"The knowledge retention group performed more poorly in some areas, suggesting that initial instruction was not reinforced beyond the novice level.
","['separate group of nursing students who had received a similar educational intervention 1.5 years prior', '37 posttest undergraduate nursing students participated', 'Thirty-eight pretest and']",[],['knowledge retention'],"[{'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",38.0,0.0125447,"The knowledge retention group performed more poorly in some areas, suggesting that initial instruction was not reinforced beyond the novice level.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'L C Jones', 'Affiliation': 'Health and Wellness Center, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Porterfield', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, FL, USA.'}]",Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/rnj.0000000000000213']
735,29288581,Comparison of Different-Gauge Needles for Fine-Needle Aspiration Biopsy of Thyroid Nodules.,"OBJECTIVES


To compare the adequacy of 23-, 25-, and 27-gauge needles in the fine-needle aspiration biopsy of thyroid nodules to develop guidelines for the collection of better specimens for cytologic diagnosis.
METHODS


This randomized prospective study included 156 consecutively enrolled patients with 156 nodules. Each nodule was aspirated with a needle of each size. The obtained specimens were analyzed independently by 2 cytopathologists, and adequacy rates were calculated.
RESULTS


In our investigation, there were no statistically significant differences among the adequacy rates achieved with 23-, 25-, and 27-gauge needles (88.5%, 90.4%, and 89.7%, respectively; P > .05). The adequacy rates achieved with all 3 needle sizes in hyperechoic nodules were higher than those in hypoechoic samples (P < .05). Finally, no differences in adequacy for the different needle sizes were observed according to nodule size (P > .05).
CONCLUSIONS


We conclude that fine-needle aspiration biopsy with a 27-gauge needle can aspirate an adequate specimen for cytopathologic diagnosis of thyroid nodules. The likelihood that inadequate materials will be obtained from hypoechoic nodules is higher than that for hyperechoic nodules.",2018,The adequacy rates achieved with all 3 needle sizes in hyperechoic nodules were higher than those in hypoechoic samples (P < .05).,['156 consecutively enrolled patients with 156 nodules'],['fine-needle aspiration biopsy with a 27-gauge needle'],"['adequacy rates', 'hyperechoic nodules']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}]","[{'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}]",156.0,0.0131635,The adequacy rates achieved with all 3 needle sizes in hyperechoic nodules were higher than those in hypoechoic samples (P < .05).,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yujiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoqu', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Linxue', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Ultrasound, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.14521']
736,31522922,Health Center-Based Community-Supported Agriculture: An RCT.,"INTRODUCTION


Socioeconomically vulnerable individuals often face poor access to nutritious food and bear a disproportionate burden of diet-related chronic illness. This study tested whether a subsidized community-supported agriculture intervention could improve diet quality.
STUDY DESIGN


An RCT was conducted from May 2017 to December 2018 (data analyzed in 2019).
SETTING/PARTICIPANTS


Adults with a BMI >25 kg/m 2  seen at a community health center in central Massachusetts, or who lived in the surrounding county, were eligible.
INTERVENTION


Individuals were randomized to receive either subsidized community-supported agriculture membership (which provided a weekly farm produce pickup from June to November) or healthy eating information (control group). For equity, the control group received financial incentives similar to the intervention group.
MAIN OUTCOME MEASURES


The primary outcome was the Healthy Eating Index 2010 total score (range, 0-100; higher indicates better diet quality; minimum clinically meaningful difference, 3). Healthy Eating Index was assessed using 3 24-hour recalls per participant collected each growing season. Intention-to-treat analyses compared Healthy Eating Index scores between the intervention and control group, accounting for repeated measures with generalized estimating equations.
RESULTS


There were 128 participants enrolled and 122 participants for analysis. The participants' mean age was 50.3 (SD=13.6) years; 82% were women; and 88% were white, non-Hispanic, with a similar distribution of baseline characteristics comparing the intervention and control groups. Baseline Healthy Eating Index total score was 53.9 (SD=15.3) in the control group and 55.1 (SD=15.2) in the intervention group (p=0.68). The intervention increased the mean Healthy Eating Index total score relative to the control group (4.3 points higher, 95% CI=0.5, 8.1, p=0.03). Food insecurity was lower in the intervention group (RR=0.68, 95% CI=0.48, 0.96).
CONCLUSIONS


A community-supported agriculture intervention resulted in clinically meaningful improvements in diet quality. Subsidized community-supported agriculture may be an important intervention for vulnerable individuals.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03231592.
SUPPLEMENT INFORMATION


This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.",2019,"Food insecurity was lower in the intervention group (RR=0.68, 95% CI=0.48, 0.96).
","['Adults with a BMI >25 kg/m 2  seen at a community health center in central Massachusetts, or who lived in the surrounding county, were eligible', '128 participants enrolled and 122 participants for analysis', '2017 to December 2018 (data analyzed in 2019', ""participants' mean age was 50.3 (SD=13.6) years; 82% were women; and 88% were white, non-Hispanic, with a similar distribution of baseline characteristics comparing the intervention and control groups""]","['Health Center-Based Community-Supported Agriculture', 'subsidized community-supported agriculture intervention', 'subsidized community-supported agriculture membership (which provided a weekly farm produce pickup from June to November) or healthy eating information (control group']","['Healthy Eating Index', 'Food insecurity', 'Healthy Eating Index scores', 'mean Healthy Eating Index total score relative', 'Healthy Eating Index 2010 total score', 'Baseline Healthy Eating Index total score', 'diet quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0557759', 'cui_str': 'Farmland'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",128.0,0.145764,"Food insecurity was lower in the intervention group (RR=0.68, 95% CI=0.48, 0.96).
","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Berkowitz', 'Affiliation': 'Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: seth_berkowitz@med.unc.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': ""O'Neill"", 'Affiliation': 'Just Roots, Greenfield, Massachusetts.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Sayer', 'Affiliation': 'Community Health Center of Franklin County, Greenfield, Massachusetts.'}, {'ForeName': 'Naysha N', 'Initials': 'NN', 'LastName': 'Shahid', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Maegan', 'Initials': 'M', 'LastName': 'Petrie', 'Affiliation': 'Community Health Center of Franklin County, Greenfield, Massachusetts.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schouboe', 'Affiliation': 'Just Roots, Greenfield, Massachusetts; TerraCorps, Lowell, Massachusetts.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Saraceno', 'Affiliation': 'Just Roots, Greenfield, Massachusetts; TerraCorps, Lowell, Massachusetts.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bellin', 'Affiliation': 'Just Roots, Greenfield, Massachusetts.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.07.015']
737,26826168,One-year effects of Project EX: A smoking intervention pilot program with Spanish adolescents.,"Adolescent smoking is a major public health problem, which has led to the development of cessation programs such as Project EX. However, there is no evidence for the long-term efficacy of cessation among Spanish adolescents. This study provides a 1-year follow-up evaluation of the Project EX tobacco use cessation program among 211 smokers. The intent-to-treat 30-day smoking quit rate for the program group was 7.81 percent ( p = .04), whereas no smokers quit in the control group ( p = .02). The intervention had a significant influence on future smoking expectation, intention, motivation to quit, and overall level of 30-day smoking. Long-term outcomes of the Project EX clinic-based program are promising for adolescent smokers in Spain.",2017,"The intent-to-treat 30-day smoking quit rate for the program group was 7.81 percent ( p = .04), whereas no smokers quit in the control group ( p = .02).","['211 smokers', 'adolescent smokers in Spain', 'Spanish adolescents']","['Project EX clinic-based program', 'Project EX tobacco use cessation program', 'Project EX']","['future smoking expectation, intention, motivation to quit, and overall level of 30-day smoking', '30-day smoking quit rate']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}]","[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",211.0,0.0151364,"The intent-to-treat 30-day smoking quit rate for the program group was 7.81 percent ( p = .04), whereas no smokers quit in the control group ( p = .02).","[{'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Espada', 'Affiliation': '1 Miguel Hernández University, Spain.'}, {'ForeName': 'María T', 'Initials': 'MT', 'LastName': 'Gonzálvez', 'Affiliation': '1 Miguel Hernández University, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Orgilés', 'Affiliation': '1 Miguel Hernández University, Spain.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Sussman', 'Affiliation': '2 University of Southern California, USA.'}]",Journal of health psychology,['10.1177/1359105315623628']
738,30130424,Correlation Between Paramedic Disaster Triage Accuracy in Screen-Based Simulations and Immersive Simulations.,"Background:  Disaster triage is an infrequent, high-stakes skill set used by emergency medical services (EMS) personnel. Screen-based simulation (SBS) provides easy access to asynchronous disaster triage education. However, it is unclear if the performance during a SBS correlates with immersive simulation performance.  Methods:  This was a nested cohort study within a randomized controlled trial (RCT). The RCT compared triage accuracy of paramedics and emergency medical technicians (EMTs) who completed an immersive simulation of a school shooting, interacted with an SBS for 13 weeks, and then completed the immersive simulation again. The participants were divided into two groups: those exposed vs. those not exposed to  60 Seconds to Survival ©  (60S) , a disaster triage SBS. The aim of the study was to measure the correlation between SBS triage accuracy and immersive simulation triage accuracy. Improvements in triage accuracy were compared among participants in the nested study before and after interacting with  60S , and with improvements in triage accuracy in a previous study in which immersive simulations were used as an educational intervention.  Results:  Thirty-nine participants completed the SBS; 26 (67%) completed at least three game plays and were included in the evaluation of outcomes of interest. The mean number of plays was 8.5 (SD =7.4). Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004). There was no correlation between the amount of improvement in overall SBS triage accuracy, instances of overtriage (P = 0.101), instances of undertriage (P = 0.523), and improvement in the second immersive simulation. A comparison of the pooled data from a previous immersive simulation study with the nested cohort data showed similar improvement in triage accuracy (P = 0.079).  Conclusions:  SBS education was associated with a significant increase in triage accuracy in an immersive simulation, although triage accuracy demonstrated in the SBS did not correlate with the performance in the immersive simulation. This improvement in accuracy was similar to the improvement seen when immersive simulation was used as the educational intervention in a previous study.",2019,"Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004).",['Thirty-nine participants completed the SBS; 26 (67%) completed at least three game plays'],['Screen-based simulation (SBS'],"['accuracy', 'triage accuracy', 'mean number of plays', 'overall SBS triage accuracy, instances of overtriage']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",39.0,0.0365779,"Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004).","[{'ForeName': 'Mark X', 'Initials': 'MX', 'LastName': 'Cicero', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Whitfill', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Maria Carmen G', 'Initials': 'MCG', 'LastName': 'Diaz', 'Affiliation': ''}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Arteaga', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Scherzer', 'Affiliation': ''}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Goldberg', 'Affiliation': ''}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Madhok', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': ''}, {'ForeName': 'Geno', 'Initials': 'G', 'LastName': 'Paesano', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Redlener', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Munjal', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2018.1475530']
739,30554932,"Is regional ankle block needed in conjunction with general anaesthesia for first ray surgery? A randomised controlled trial of ultrasound guided ankle block versus ""blind"" local infiltration.","BACKGROUND


Regional anaesthesia is commonly utilised for foot and ankle surgery. Debate remains at to the level of regional anaesthesia that is required. The objective of this study was to evaluate whether surgeon-delivered ""blind"" local anaesthetic infiltration around the first ray (metatarsal block without ultrasound guidance) was as effective as an ultrasound guided ankle block in providing post-operative analgesia after osseous first ray surgery performed under general anaesthetic.
METHODS


50 patients were recruited to a single surgeon and anaesthetist double-blinded randomised controlled trial at a single-centre. 20mls of 0.5% levobupivacaine was used to perform either an ankle or metatarsal nerve block.
RESULTS


Forty-eight patients completed the study: 25 in the ankle block treatment arm and 23 in the metatarsal block arm. The demographics were comparable between groups. There was no statistical difference in visual analogue pain scores at two (21.3 vs 15.2), six (23.6 vs 20.8) and 24 (42.2 vs 50.4) hours following the procedure between the two groups (metatarsal block vs ankle block). Metatarsal block groups had a faster return of normal sensation (2.3 vs 2.8h) but there was no difference in time to safe mobilisation (2.6 vs 2.8h).
CONCLUSION


This study demonstrates the efficacy and safety of surgeon delivered ""blind"" metatarsal block is comparable to an ultrasound guided ankle block for first ray surgery performed under general anaesthetic.
LEVEL OF EVIDENCE


1.",2020,"There was no statistical difference in visual analogue pain scores at two (21.3 vs 15.2), six (23.6 vs 20.8) and 24 (42.2 vs 50.4) hours following the procedure between the two groups (metatarsal block vs ankle block).","['50 patients were recruited to a single surgeon and anaesthetist double-blinded randomised controlled trial at a single-centre', 'Forty-eight patients completed the study: 25 in the ankle block treatment arm and 23 in the metatarsal block arm']","['ultrasound guided ankle block versus ""blind"" local infiltration', 'levobupivacaine', 'surgeon-delivered ""blind"" local anaesthetic infiltration around the first ray (metatarsal block without ultrasound guidance', 'surgeon delivered ""blind"" metatarsal block']","['faster return of normal sensation', 'efficacy and safety', 'time to safe mobilisation', 'visual analogue pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0473161', 'cui_str': 'Anesthetist'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0394745', 'cui_str': 'Local anesthetic ankle block (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394745', 'cui_str': 'Local anesthetic ankle block (procedure)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}, {'cui': 'C0450284', 'cui_str': 'First ray (body structure)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0576709', 'cui_str': 'Normal sensation (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",50.0,0.391939,"There was no statistical difference in visual analogue pain scores at two (21.3 vs 15.2), six (23.6 vs 20.8) and 24 (42.2 vs 50.4) hours following the procedure between the two groups (metatarsal block vs ankle block).","[{'ForeName': 'Veronica I', 'Initials': 'VI', 'LastName': 'Roberts', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Randeep S', 'Initials': 'RS', 'LastName': 'Aujla', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK. Electronic address: Randeep.aujla@hotmail.co.uk.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Vinay', 'Affiliation': ''}, {'ForeName': 'Felix N', 'Initials': 'FN', 'LastName': 'Fombon', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Bhatia', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2018.11.012']
740,30238430,Change of skeletal muscle mass in patients with pheochromocytoma.,"The effects of catecholamine excess due to pheochromocytoma on body composition, including skeletal muscle mass, are unknown. Here, we investigated the effects of catecholamine metabolites on body composition in subjects with pheochromocytoma. After body compositions using bioelectrical impedance analysis, urinary metanephrine (UM), and urinary normetanephrine (UNM) were measured in 16 patients with pheochromocytoma and 224 patients with nonfunctioning adrenal incidentaloma (NFAI), we compared skeletal muscle mass and fat mass (FM) between the two groups. After adjustments for confounders, UM (β = - 0.171, P = 0.006) and UNM (β = - 0.249, P < 0.001) levels were correlated inversely with skeletal muscle mass index (SMI), but not FM or percentage FM (pFM), in all subjects. Patients with pheochromocytoma had lower ASM by 7.7% (P = 0.022) and SMI by 6.6% (P = 0.001) than patients with NFAI. Conversely, FM and pFM were not statistically different between the two groups. The odds ratio for low skeletal muscle mass in the presence of pheochromocytoma was 10.33 (95% confidence interval, 2.65-40.22). Our results indicate that patients with pheochromocytoma have a reduced skeletal muscle mass and suggest that catecholamine excess has adverse effects on skeletal muscle metabolism.",2019,Patients with pheochromocytoma had lower ASM by 7.7% (P = 0.022) and SMI by 6.6% (P = 0.001) than patients with NFAI.,"['16 patients with pheochromocytoma and 224 patients with nonfunctioning adrenal incidentaloma (NFAI', 'subjects with pheochromocytoma', 'patients with pheochromocytoma']","['catecholamine metabolites', 'catecholamine']","['SMI', 'body composition', 'lower ASM', 'FM and pFM', 'bioelectrical impedance analysis, urinary metanephrine (UM), and urinary normetanephrine (UNM', 'skeletal muscle mass', 'skeletal muscle mass index (SMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031511', 'cui_str': 'Pheochromocytoma'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C2609247', 'cui_str': 'Adrenal incidentaloma'}]","[{'cui': 'C1291743', 'cui_str': 'Catecholamine metabolite'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0025562', 'cui_str': 'Metadrenaline'}, {'cui': 'C0028385', 'cui_str': '3-Methoxynoradrenaline'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0682476,Patients with pheochromocytoma had lower ASM by 7.7% (P = 0.022) and SMI by 6.6% (P = 0.001) than patients with NFAI.,"[{'ForeName': 'Seung Hun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kwak', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Seong Hee', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Hyeonmok', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yoon Young', 'Initials': 'YY', 'LastName': 'Cho', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Gyeongsang National University School of Medicine, Jinju, South Korea.'}, {'ForeName': 'Sunghwan', 'Initials': 'S', 'LastName': 'Suh', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Dong-A University Medical Center, Dong-A, University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Kee-Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Koh', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea. jaehyeon@skku.edu.'}, {'ForeName': 'Beom-Jun', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea. umkbj0825@amc.seoul.kr.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-018-0959-3']
741,31545663,Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.,"PURPOSE


Chemotherapy-induced thrombocytopenia (CIT) leads to delay or reduction in cancer treatment. There is no approved treatment.
METHODS


We conducted a phase II randomized trial of romiplostim versus untreated observation in patients with solid tumors with CIT. Before enrollment, patients had platelets less than 100,000/μL for at least 4 weeks, despite delay or dose reduction of chemotherapy. Patients received weekly titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care. The primary end point was correction of platelet count within 3 weeks. Twenty-three patients were treated in a randomization phase, and an additional 37 patients were treated in a single-arm, romiplostim phase. Resumption of chemotherapy without recurrent CIT was a secondary end point.
RESULTS


The mean platelet count at enrollment was 62,000/μL. In the randomization phase, 14 of 15 romiplostim-treated patients (93%) experienced correction of their platelet count within 3 weeks, compared with one of eight control patients (12.5%;  P  < .001). Including all romiplostim-treated patients (N = 52), the mean platelet count at 2 weeks of treatment was 141,000/μL. The mean platelet count in the eight observation patients at 3 weeks was 57,000/μL. Forty-four patients who achieved platelet correction with romiplostim resumed chemotherapy with weekly romiplostim. Only three patients (6.8%) experienced recurrent reduction or delay of chemotherapy because of isolated CIT.
CONCLUSION


This prospective trial evaluated treatment of CIT with romiplostim. Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",2019,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",['patients with solid tumors with CIT'],"['romiplostim', 'titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care']","['recurrent reduction or delay of chemotherapy', 'despite delay or dose reduction of chemotherapy', 'mean platelet count', 'correction of platelet count', 'correction of their platelet count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}]","[{'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1299577', 'cui_str': 'Delay of chemotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}]",44.0,0.0328062,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.","[{'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Bendheim', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Batista', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jodi V', 'Initials': 'JV', 'LastName': 'Mones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Parameswaran', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Cy R', 'Initials': 'CR', 'LastName': 'Wilkins', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Devlin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cercek', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Kemeny', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mantha', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01931']
742,30284319,Clinical efficacy of the graft free slit-window sinus floor elevation procedure: A 2-year randomized controlled clinical trial.,"OBJECTIVE


Slit-window technique is a lateral approach sinus floor elevation (SFE) procedure that utilizes a rigid resorbable membrane in conjunction with stabilizing bony slits to tent the Schneiderian membrane without addition of grafting materials. The aim of this randomized clinical trial was to compare clinical and radiographic outcomes of the Slit-window SFE with those of SFE with bone grafting.
MATERIAL AND METHODS


Thirty-three patients with 38 edentulous sites were included. Edentulous sites were randomly allocated to the Slit-window SFE or SFE with bone grafting. Simultaneous with SFE, each site received two dental implants. Implant stability quotient (ISQ) values were recorded at baseline and monthly visits for 8 months. The bone coverage and bone height gain at implant sites were recorded on cone beam computed tomography (CBCT) scans 6 and 24 months postoperatively.
RESULTS


There were no significant differences in the mean ISQ values between the groups at any time point (p > 0.05). All implants in both groups were found to have complete bone coverage. Significant increases in the bone height were found 6 and 24 months postoperatively in both groups (p < 0.001).
CONCLUSIONS


Within limitations of the present study, it can be concluded that the Slit-window SFE technique without the need for bone grafting resulted in sufficient bone height gain around implants placed simultaneous with the SFE procedures. The bone height around these implants was stable during the 2-year follow-up period. The treatment outcomes for these implants were comparable to those placed simultaneous with lateral approach SFE in conjunction with bone grafting.",2018,"Significant increases in the bone height were found 6 and 24 months postoperatively in both groups (p < 0.001).
","['Edentulous sites', 'Thirty-three patients with 38 edentulous sites were included']","['SFE with bone grafting', 'Slit-window SFE or SFE with bone grafting', 'Slit-window SFE', 'graft free slit-window sinus floor elevation procedure']","['mean ISQ values', 'bone coverage and bone height gain', 'complete bone coverage', 'bone height', 'Implant stability quotient (ISQ) values', 'bone height gain']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1870204', 'cui_str': '(18F)SFE'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]",33.0,0.0481374,"Significant increases in the bone height were found 6 and 24 months postoperatively in both groups (p < 0.001).
","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ranaan', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, Massachusetts.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Bassir', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, Massachusetts.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Andrada', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, Massachusetts.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Shamshiri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Maksoud', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, Massachusetts.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Raanan', 'Affiliation': 'Private Practice, Beverly Hills, California.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Guze', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, Massachusetts.'}]",Clinical oral implants research,['10.1111/clr.13374']
743,30267699,Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial.,"PURPOSE


To assess the hypothesis that fluorometholone 0.1% eye drops are safe and effective as adjunctive therapy for trachomatous trichiasis (TT) surgery; determining the most promising dose.
DESIGN


Randomized, placebo-controlled, double-masked parallel dose-ranging clinical trial.
METHODS


Patients undergoing upper lid TT surgery at a rural Ethiopian hospital were randomized to fluorometholone 0.1% twice daily for 4 weeks, 4 times daily for 4 weeks, 4 times daily for 8 weeks, or matching frequency placebo in a 3:1:3:1:3:1 ratio for 1 eye. Randomization was stratified by TT severity (1-4 vs ≥5 lashes touching the globe). Safety outcomes (intraocular pressure [IOP] elevation, cataract, and other dose-limiting toxicities) and postoperative TT incidence were assessed over 1 year.
RESULTS


Subjects randomized were 39:13:39:13:38:13 in the respective groups, and 1 subject in the 8-weeks fluorometholone group was withdrawn. Of 154 subjects, 148 (96.1%) completed 1 year's follow-up. Among 76 eyes receiving fluorometholone 4 times daily, 1 developed IOP elevation ≥ 30 mm Hg (to 37 mm Hg) and 1 had an allergic reaction attributed to the study drug; each resolved upon drug cessation without sequelae. No cataract or other dose-limiting toxicity events occurred. Postoperative TT within 1 year occurred in 29.3% of placebo eyes vs 17.7%, 19.6%, and 23.2% among the respective fluorometholone groups (P = .29 comparing placebo vs all active treatments combined).
CONCLUSIONS


The results suggest fluorometholone 0.1% is likely to be safe and efficacious to reduce postoperative TT following TT surgery, and 1 drop twice daily for 4 weeks is the most promising dose. Confirmation in a full-scale clinical trial is needed before programmatic implementation.",2019,"Postoperative TT within 1 year occurred in 29.3% of placebo eyes vs 17.7%, 19.6%, and 23.2% among the respective fluorometholone groups (P =","['Trachomatous Trichiasis Surgery', ""Of 154 subjects, 148 (96.1%) completed 1 year's follow-up"", '76 eyes receiving', 'Patients undergoing upper lid TT surgery at a rural Ethiopian hospital']","['fluorometholone', 'Fluorometholone', 'placebo']","['Postoperative TT', 'Safety outcomes (intraocular pressure [IOP] elevation, cataract, and other dose-limiting toxicities) and postoperative TT incidence', 'IOP elevation ≥', 'allergic reaction']","[{'cui': 'C0221259', 'cui_str': 'Trichiasis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0016351', 'cui_str': 'Fluorometholone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}]",154.0,0.587953,"Postoperative TT within 1 year occurred in 29.3% of placebo eyes vs 17.7%, 19.6%, and 23.2% among the respective fluorometholone groups (P =","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA; MCM Eye Unit, MyungSung Christian Medical Center, General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia. Electronic address: john_kempen@meei.harvard.edu.'}, {'ForeName': 'Redda', 'Initials': 'R', 'LastName': 'Tekle-Haimanot', 'Affiliation': 'General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia; Grarbet Tehadiso Mahber, Addis Ababa, Ethiopia.'}, {'ForeName': 'Lelisa', 'Initials': 'L', 'LastName': 'Hunduma', 'Affiliation': 'Grarbet Tehadiso Mahber, Addis Ababa, Ethiopia; Grarbet Hospital, Butajira, Ethiopia.'}, {'ForeName': 'Menilik', 'Initials': 'M', 'LastName': 'Alemayehu', 'Affiliation': 'Eye Department, Shashemene Referral Hospital, Shashemene, Ethiopia.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Pistilli', 'Affiliation': 'Berhan Public Health and Eye Care Consultancy, Addis Ababa, Ethiopia; Department of Ophthalmology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA; Department of Epidemiology, Drexel University School of Public Health, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Abashawl', 'Affiliation': 'Eye Department, Shashemene Referral Hospital, Shashemene, Ethiopia.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Lawrence', 'Affiliation': 'MCM Eye Unit, MyungSung Christian Medical Center, General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia; Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan Medicine School, Ann Arbor, Michigan, USA; Department of Ophthalmology, Hamilton Eye Institute, University of Tennessee Health Science Center, College of Medicine, Memphis, Tennessee, USA.'}, {'ForeName': 'Wondu', 'Initials': 'W', 'LastName': 'Alemayehu', 'Affiliation': 'Eye Department, Shashemene Referral Hospital, Shashemene, Ethiopia; The Fred Hollows Foundation, Addis Ababa, Ethiopia.'}]",American journal of ophthalmology,['10.1016/j.ajo.2018.09.017']
744,30333315,Pilot studies demonstrate the potential benefits of antiinflammatory therapy in human lymphedema.,"BACKGROUND


Lymphedema is a common condition affecting millions around the world that still lacks approved medical therapy. Because ketoprofen, an NSAID, has been therapeutic in experimental lymphedema, we evaluated its efficacy in humans.
METHODS


We first performed an exploratory open-label trial. Patients with either primary or secondary lymphedema received ketoprofen 75 mg by mouth 3 times daily for 4 months. Subjects were evaluated for changes in histopathology, with skin thickness, limb volume, and tissue bioimpedance changes serving as secondary endpoints. Based on our encouraging findings, we next conducted a placebo-controlled trial, with the primary outcome defined as a change in skin thickness, as measured by skin calipers. Secondary endpoints for this second study included histopathology, limb volume, bioimpedance, and systemic inflammatory mediators.
RESULTS


We enrolled 21 lymphedema patients in the open-label trial, from November 2010 to July 2011. Histopathology and skin thickness were significantly improved at 4 months compared with baseline. In the follow-up, double-blind, placebo-controlled trial, we enrolled 34 patients from August 2011 to October 2015, with 16 ketoprofen recipients and 18 placebo-treated subjects. No serious adverse events occurred. The ketoprofen recipients demonstrated reduced skin thickness, as well as improved composite measures of histopathology and decreased plasma granulocyte CSF (G-CSF) expression.
CONCLUSION


These 2 exploratory studies together support the utility of targeted antiinflammatory therapy with ketoprofen in patients with lymphedema. Our results highlight the promise of such approaches to help restore a failing lymphatic circulation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02257970.",2018,"The ketoprofen recipients demonstrated reduced skin thickness, as well as improved composite measures of histopathology and decreased plasma granulocyte CSF (G-CSF) expression.
","['human lymphedema', 'Patients with either primary or secondary lymphedema', '34 patients from August 2011 to October 2015, with 16 ketoprofen recipients and 18 placebo-treated subjects', 'patients with lymphedema', '21 lymphedema patients in the open-label trial, from November 2010 to July 2011']","['ketoprofen', 'antiinflammatory therapy', 'placebo']","['change in skin thickness, as measured by skin calipers', 'Histopathology and skin thickness', 'reduced skin thickness', 'plasma granulocyte CSF (G-CSF) expression', 'changes in histopathology, with skin thickness, limb volume, and tissue bioimpedance changes serving', 'histopathology, limb volume, bioimpedance, and systemic inflammatory mediators']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema (disorder)'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C1096024', 'cui_str': 'Antiinflammatory therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0175720', 'cui_str': 'Caliper, device (physical object)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]",21.0,0.162065,"The ketoprofen recipients demonstrated reduced skin thickness, as well as improved composite measures of histopathology and decreased plasma granulocyte CSF (G-CSF) expression.
","[{'ForeName': 'Stanley G', 'Initials': 'SG', 'LastName': 'Rockson', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care System/Stanford University, Palo Alto, California, USA.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care System/Stanford University, Palo Alto, California, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Kuznetsova', 'Affiliation': 'Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven, Belgium.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Zampell', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mehrara', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Sampson', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Roche', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Jinah', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nicolls', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care System/Stanford University, Palo Alto, California, USA.'}]",JCI insight,['10.1172/jci.insight.123775']
745,30150345,Unusual case of dasatinib-associated acute bilateral hyphemas leading to blindness in a patient with chronic myeloid leukaemia.,"Chronic myeloid leukaemia (CML) is a myeloproliferative disorder with an incidence of 1-2 cases per 100 000 adults per year. 1  Since the International Randomized Study of Interferon and STI571 trial (IRIS trial) in 2003, treatment with tyrosine kinase inhibitors (TKIs) has become the standard of care for patients with newly diagnosed CML in the chronic phase. 2  Dasatinib is a second-generation TKI and is generally well tolerated, with cytopenias, gastrointestinal (GI) symptoms and fluid retention being the most commonly observed side effects. 3-5  Bleeding complications, although unusual, have been reported with dasatinib, with an incidence ranging from 8% to 24%. 3-6  The most commonly reported site of bleeding is the GI tract. 3 5  We report an unusual case of dasatinib-associated bleeding presenting with acute bilateral hyphemas, which, to our knowledge, is the first report of its kind.",2018,"Since the International Randomized Study of Interferon and STI571 trial (IRIS trial) in 2003, treatment with tyrosine kinase inhibitors (TKIs) has become the standard of care for patients with newly diagnosed CML in the chronic phase.","['Chronic myeloid leukaemia (CML', 'patients with newly diagnosed CML in the chronic phase', 'patient with chronic myeloid leukaemia']","['Interferon and STI571', 'tyrosine kinase inhibitors (TKIs']",[],"[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0906802', 'cui_str': 'STI-571'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],,0.0559164,"Since the International Randomized Study of Interferon and STI571 trial (IRIS trial) in 2003, treatment with tyrosine kinase inhibitors (TKIs) has become the standard of care for patients with newly diagnosed CML in the chronic phase.","[{'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Hematology/Medical Oncology, Monter Cancer Center, Lake Success, New York, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Garg', 'Affiliation': 'Hematology/Medical Oncology, Monter Cancer Center, Lake Success, New York, USA.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Ghiuzeli', 'Affiliation': 'Hematology/Medical Oncology, Monter Cancer Center, Lake Success, New York, USA.'}]",BMJ case reports,['10.1136/bcr-2018-225705']
746,32409106,Safety Analysis of Five Randomized Controlled Studies of Daratumumab in Patients With Multiple Myeloma.,"BACKGROUND


Multiple studies have demonstrated the efficacy and safety of daratumumab for relapsed/refractory multiple myeloma (MM) and primary treatment for transplant-eligible and -ineligible patients.
MATERIALS AND METHODS


We conducted an integrated safety analysis to characterize the frequency, severity, natural history, and outcomes of adverse events (AEs) with daratumumab versus comparators. Data were pooled from 5 completed phase III randomized controlled studies that had included 1798 daratumumab-treated and 1797 comparator-treated patients with MM as a first line in both transplant-eligible and transplant-ineligible patients and for relapsed/refractory disease. Safety analyses included reporting of AEs using crude and exposure-adjusted incidence rates.
RESULTS


The median follow-up duration was 16.84 months (range, 7.4-28 months) for both daratumumab-treated and comparator-treated patients. Discontinuation for any reason occurred less often with daratumumab (22% vs. 33.9%), although discontinuation because of AEs occurred at similar rates (25% vs. 26%) as did deaths owing to AEs (2.25% vs. 1.84%). When adjusted for exposure, neutropenia, lymphopenia, diarrhea, fatigue, dyspnea, pneumonia, and hypertension were the only common grade 3/4 AEs reported more often with daratumumab than with the comparators. The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively). Grade 3/4 daratumumab infusion-related reactions happened in 3.8% of patients. The majority of infusion-related reactions occurred after the first infusion.
CONCLUSIONS


These results from an integrated analysis support a favorable benefit/risk profile of daratumumab in patients with MM.",2020,"The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively).","['patients with MM', 'Data were pooled from 5 completed phase III randomized controlled studies that had included 1798 daratumumab-treated and 1797 comparator-treated patients with MM as a first line in both transplant-eligible and transplant-ineligible patients and for relapsed/refractory disease', 'Patients With Multiple Myeloma']",[],"['exposure, neutropenia, lymphopenia, diarrhea, fatigue, dyspnea, pneumonia, and hypertension', 'reporting of AEs using crude and exposure-adjusted incidence rates', 'neutropenia, lymphopenia, and pneumonia', 'majority of infusion-related reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.125714,"The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively).","[{'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Al Hadidi', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX. Electronic address: hadidi@bcm.edu.'}, {'ForeName': 'Courtney Nicole', 'Initials': 'CN', 'LastName': 'Miller-Chism', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Rammurti', 'Initials': 'R', 'LastName': 'Kamble', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Mims', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.04.004']
747,30296920,Efficacy of dry needling in patients with myofascial temporomandibular disorders related to the masseter muscle.,"OBJECTIVE


This randomized, single-center clinical trial aimed to compare the efficacy of superficial dry needling (SDN) and deep dry needling (DDN) in patients with myofascial temporomandibular disorder (MTMD) related to the masseter muscle. Methods : Forty patients showing MTMD with trigger points in the masseter muscle were randomly assigned to groups. Dry needling of the masseter muscle was performed once per week for three weeks. Pressure pain threshold (PPT) measurements, visual analog scale scores, and maximal jaw opening were assessed. Results : Both patient groups showed significant pain reduction, but the SDN group showed significantly better pain reduction. The PPT measurements obtained in the follow-up examinations at three and six weeks were significantly better than the values in SDN and DDN groups. Discussion : SDN showed better pain-reduction efficacy in patients with MTMD. Further research with a larger size sample and a longer follow-up period will help elucidate the benefits of SDN.",2020,"The PPT measurements obtained in the follow-up examinations at three and six weeks were significantly better than the values in SDN and DDN groups.
","['patients with myofascial temporomandibular disorder (MTMD', 'Forty patients showing MTMD with trigger points in the masseter muscle', 'patients with MTMD', 'patients with myofascial temporomandibular disorders related to the masseter muscle']","['superficial dry needling (SDN) and deep dry needling (DDN', 'dry needling']","['pain reduction', 'Pressure pain threshold (PPT) measurements, visual analog scale scores, and maximal jaw opening', 'pain-reduction efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0024876', 'cui_str': 'Masseter Muscle'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",40.0,0.0556821,"The PPT measurements obtained in the follow-up examinations at three and six weeks were significantly better than the values in SDN and DDN groups.
","[{'ForeName': 'Mehmet Cem', 'Initials': 'MC', 'LastName': 'Özden', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}, {'ForeName': 'Berkem', 'Initials': 'B', 'LastName': 'Atalay', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}, {'ForeName': 'Ali Veysel', 'Initials': 'AV', 'LastName': 'Özden', 'Affiliation': 'Department of Physiotherapy, Rehabilitation, Health Sciences Institute, Bahçeşehir University , İstanbul, Turkey.'}, {'ForeName': 'Abdülkadir', 'Initials': 'A', 'LastName': 'Çankaya', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}, {'ForeName': 'Erdinç', 'Initials': 'E', 'LastName': 'Kolay', 'Affiliation': 'Department of Statistics, Faculty of Science, Sinop University , Sinop, Turkey.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2018.1526848']
748,30288488,Comparison of pre-treatment with OCPs or estradiol valerate vs. no pre-treatment prior to GnRH antagonist used for IVF cycles: An RCT.,"Background


Both oral contraceptive pills (OCPs) and estradiol valerate (E2) have been used to schedule a gonadotropin-releasing hormone antagonist in vitro fertilization (IVF) cycles. Since the suppression of follicle-stimulating hormone by OCPs can stay 5-7 days after stopping the pills, it seems that starting the gonadotropin-releasing hormone (GnRH) after 6 days of pre-treatment discontinuation may be important in IVF outcomes.
Objective


The aim of the present study was to determine the number of mature oocyte and pregnancy rate of three pretreatment methods for fresh embryo transfer cycles.
Materials and Methods


In this randomized controlled trial, two-hundred ten women (18-35 yr and less than 2 previous IVF attempts) undergoing IVF with the GnRH antagonist protocol were randomized to the OCP, E2, and no pretreatment arms. OCP group (n=53) received OCP (ethinyl estradiol30 μg and levonorgestrel150 μg), E2 group (n=63) received 4 mg/day oral E2 (17β-E2) for 10 days from day 20 of the previous cycle and GnRH antagonist stimulation was started 6 days after the interruption of OCP and E2. The control group (n =70) did not receive any pretreatment.
Results


No significant difference was observed in the mean number of the mature oocyte, endometrial thickness, and embryo quality. The pregnancy rate in E2 group was higher than the two other groups (42.9% vs 39.6% and 34.3% in OCP and control group, respectively), but the difference was not statistically significant (p=0.59).
Conclusion


It seems OCP or E2 pretreatment could not improve the fresh IVF-embryo transfer outcomes.",2018,"No significant difference was observed in the mean number of the mature oocyte, endometrial thickness, and embryo quality.",['two-hundred ten women (18-35 yr and less than 2 previous IVF attempts) undergoing IVF with the GnRH antagonist protocol'],"['OCP', '\n\n\nBoth oral contraceptive pills (OCPs) and estradiol valerate (E2', 'OCPs or estradiol valerate', 'OCP (ethinyl estradiol30 μg and levonorgestrel150 μg), E2 group (n=63) received 4 mg/day oral E2 (17β-E2']","['mean number of the mature oocyte, endometrial thickness, and embryo quality', 'pregnancy rate', 'number of mature oocyte and pregnancy rate', 'fresh IVF-embryo transfer outcomes']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0059623', 'cui_str': 'estradiol valerate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",210.0,0.0923242,"No significant difference was observed in the mean number of the mature oocyte, endometrial thickness, and embryo quality.","[{'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Shahrokh Tehrani Nejad', 'Affiliation': 'Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bakhtiari Ghaleh', 'Affiliation': 'Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Eslami', 'Affiliation': 'Breast Disease Research Center (BDRC), Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fedyeh', 'Initials': 'F', 'LastName': 'Haghollahi', 'Affiliation': 'Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Bagheri', 'Affiliation': 'Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Masoumi', 'Affiliation': 'Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
749,30523414,Efficacy and safety of once-monthly risedronate in osteoporosis subjects with mild-to-moderate chronic kidney disease: a post hoc subgroup analysis of a phase III trial in Japan.,"Limited data are available on the safety and efficacy of anti-resorptive agents, particularly once-monthly bisphosphonates, for use in osteoporotic patients with chronic kidney disease (CKD). We conducted a post hoc analysis of data from a 12-month, randomized, double-blind, phase III study to evaluate the safety and efficacy of once-monthly risedronate (RIS-OM) 75 mg tablets in Japanese osteoporosis patients with mild-to-moderate CKD. Patients who received RIS-OM 75 mg were stratified by baseline estimated glomerular filtration rate (eGFR; ≥ 90, ≥ 60 to < 90, or ≥ 30 to < 60 mL/min/1.73 m 2 ). Safety endpoints were incidence of adverse events (AEs) and percent change from baseline in eGFR, serum creatinine, calcium, and phosphorus. Efficacy endpoints were percent change from baseline in lumbar spine bone mineral density (BMD) and bone turnover markers (BTMs). In 420 patients included (age 67.7 ± 6.7 years, women 98.8%), the incidence of all AEs, gastrointestinal disorders, acute phase reaction, non-vertebral fractures, and renal and urinary disorders was not significantly different among subgroups. Interaction between subgroups and time was significant for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be regression to the mean and clinically insignificant. BMD significantly increased while BTMs significantly decreased from baseline with a similar degree of change among the subgroups. In conclusion, RIS-OM 75 mg showed consistent safety and efficacy in suppressing bone turnover and increasing BMD in Japanese primary osteoporosis patients with mild-to-moderate CKD. These results should, however, be interpreted with caution because the number of patients with moderate CKD was limited.",2019,Interaction between subgroups and time was significant for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be regression to the mean and clinically insignificant.,"['Japanese primary osteoporosis patients with mild-to-moderate CKD', 'Japanese osteoporosis patients with mild-to-moderate CKD', 'eGFR; ≥ 90, ≥ 60 to\u2009< 90, or\u2009≥ 30 to', '420 patients included (age 67.7\u2009±\u20096.7\xa0years, women 98.8', 'osteoporotic patients with chronic kidney disease (CKD', 'osteoporosis subjects with mild-to-moderate chronic kidney disease']","['RIS-OM', 'risedronate', 'risedronate (RIS-OM']","['serum creatinine', 'safety and efficacy', 'lumbar spine bone mineral density (BMD) and bone turnover markers (BTMs', 'BMD', 'bone turnover and increasing BMD', 'eGFR', 'Efficacy and safety', 'incidence of all AEs, gastrointestinal disorders, acute phase reaction, non-vertebral fractures, and renal and urinary disorders', 'glomerular filtration rate', 'BTMs', 'incidence of adverse events (AEs) and percent change from baseline in eGFR, serum creatinine, calcium, and phosphorus']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0246719', 'cui_str': 'Risedronate'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0001349', 'cui_str': 'Response, Acute-Phase'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0042075', 'cui_str': 'Urological Diseases'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}]",420.0,0.0565696,Interaction between subgroups and time was significant for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be regression to the mean and clinically insignificant.,"[{'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Internal Medicine, 1, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Inoue', 'Affiliation': 'Third Department of Medicine, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara-shi, Chiba, 299-0111, Japan. inoued@med.teikyo-u.ac.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Maehara', 'Affiliation': 'EA Pharma Co., Ltd., 2-1-1 Irifune, Chuo-ku, Tokyo, 104-0042, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Oikawa', 'Affiliation': 'EA Pharma Co., Ltd., 2-1-1 Irifune, Chuo-ku, Tokyo, 104-0042, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama-shi, Wakayama, 641-8509, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-018-0977-1']
750,30189025,The course and predictors of perceived unsupportive responses by family and friends among women newly diagnosed with gynecological cancers.,"Perceived unsupportive responses from close others play an important role in psychological adaptation of patients with cancer. Little is known about whether these negative responses change after someone experiences a serious life event, and even less is known about the individual characteristics and related factors that might contribute to both the levels of and changes in perceived unsupportive responses over the course of adaptation to an experience. This longitudinal study aimed to evaluate changes in perceived unsupportive behavior from family and friends among women newly with gynecologic cancer as well as initial demographic, disease, and psychological factors that predict the course of perceived unsupportive behavior over time. Women (N = 125) assigned to the usual care arm of a randomized clinical trial comparing a coping and communication intervention with a supportive counseling intervention to usual care completed six surveys over an 18 month period. Growth models using multilevel modeling were used to predict unsupportive responses over time. Average levels of perceived unsupportive responses from family and friends were low. Unsupportive responses varied from patient to patient, but patients did not report a systematic change in perceived unsupportive responses over time. Cultivating meaning and peace and coping efficacy were associated with fewer perceived unsupportive responses as well as reductions in perceived unsupportive responses over time. Emotional distress, cancer concerns, functional impairment, holding back sharing concerns, and cognitive and behavioral avoidance predicted higher perceived unsupportive responses over time. The findings are discussed in terms of the self-presentation theory and social network responses to persons undergoing difficult life events.",2019,"Unsupportive responses varied from patient to patient, but patients did not report a systematic change in perceived unsupportive responses over time.","['women newly diagnosed with gynecological cancers', 'family and friends among women newly with gynecologic cancer', 'patients with cancer']",['coping and communication intervention with a supportive counseling intervention to usual care completed six surveys over an 18 month period'],"['Emotional distress, cancer concerns, functional impairment, holding back sharing concerns, and cognitive and behavioral avoidance', 'Unsupportive responses', 'Cultivating meaning and peace and coping efficacy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1553387', 'cui_str': 'Hold'}]",125.0,0.0181031,"Unsupportive responses varied from patient to patient, but patients did not report a systematic change in perceived unsupportive responses over time.","[{'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Manne', 'Affiliation': 'Department of Medicine, Rutgers Robert Wood Johnson Medical School, Section of Population Science, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kashy', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kissane', 'Affiliation': 'Department of Psychiatry, Monash University, Melbourne, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ozga', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shannon Myers', 'Initials': 'SM', 'LastName': 'Virtue', 'Affiliation': 'Clinical Psychology, Helen Graham Cancer Center, Christiana Care Health System, Wilmington, DE, USA.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Heckman', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, Temple Health, Philadelphia, PA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby087']
751,29781394,Effects of cognitive-behavioral therapy with relaxation vs. imagery rescripting on psychophysiological stress responses of students with test anxiety in a randomized controlled trial.,"Background and objectives:  Psychophysiological measures were assessed in university students during a test simulation before and after group treatment for test anxiety based on cognitive behavioral therapy (CBT), including relaxation techniques (CBT + R) or imagery rescripting (CBT + ImRs) and a moderated self-help group (SH) to understand if psychophysiological stress responses change after treatment.  Design:  Students suffering from test anxiety were recruited ( n  = 180) and three different test anxiety treatments administered in 3-hr group sessions once a week over a period of five weeks.  Methods:  During an experimental socially evaluative situation state anxiety and physiological stress responses of participants were obtained before and after treatment.  Results:  In all treatment groups, self-reported state anxiety in a stressful socially evaluative situation declined after treatment. Contrary to our hypotheses no significant reduction of physiological reactivity scores after intervention was found in any of the three group treatments.  Conclusions:  CBT and SH treatments are successful in reducing self-reported state anxiety in a socially evaluative situation, but psychophysiological stress responses in test anxiety patients remained unchanged despite all treatments.",2019,"Contrary to our hypotheses no significant reduction of physiological reactivity scores after intervention was found in any of the three group treatments.
","['university students', 'Students suffering from test anxiety were recruited (n\u2009=\u2009180', 'students with test anxiety']","['cognitive behavioral therapy (CBT), including relaxation techniques (CBT\u2009+\u2009R) or imagery rescripting (CBT\u2009+\u2009ImRs) and a moderated self-help group (SH', 'CBT and SH', 'cognitive-behavioral therapy with relaxation vs. imagery rescripting']","['state anxiety', 'physiological reactivity scores', 'psychophysiological stress responses']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035029', 'cui_str': 'Relaxation Technics'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0202054,"Contrary to our hypotheses no significant reduction of physiological reactivity scores after intervention was found in any of the three group treatments.
","[{'ForeName': 'Neele', 'Initials': 'N', 'LastName': 'Reiss', 'Affiliation': 'Department of Psychology, Goethe-University Frankfurt , Frankfurt am Main , Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Warnecke', 'Affiliation': 'Department of Psychology, Goethe-University Frankfurt , Frankfurt am Main , Germany.'}, {'ForeName': 'Ana Nanette', 'Initials': 'AN', 'LastName': 'Tibubos', 'Affiliation': 'Department of Psychology, Goethe-University Frankfurt , Frankfurt am Main , Germany.'}, {'ForeName': 'Theano', 'Initials': 'T', 'LastName': 'Tolgou', 'Affiliation': 'Department of Psychology, Goethe-University Frankfurt , Frankfurt am Main , Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Luka-Krausgrill', 'Affiliation': 'Center for Student Counseling, Johannes Gutenberg University Mainz , Mainz , Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Rohrmann', 'Affiliation': 'Department of Psychology, Goethe-University Frankfurt , Frankfurt am Main , Germany.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2018.1475767']
752,29986673,The BabySeq project: implementing genomic sequencing in newborns.,"BACKGROUND


The greatest opportunity for lifelong impact of genomic sequencing is during the newborn period. The ""BabySeq Project"" is a randomized trial that explores the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of healthy and sick newborns.
METHODS


Families of newborns are enrolled from Boston Children's Hospital and Brigham and Women's Hospital nurseries, and half are randomized to receive genomic sequencing and a report that includes monogenic disease variants, recessive carrier variants for childhood onset or actionable disorders, and pharmacogenomic variants. All families participate in a disclosure session, which includes the return of results for those in the sequencing arm. Outcomes are collected through review of medical records and surveys of parents and health care providers and include the rationale for choice of genes and variants to report; what genomic data adds to the medical management of sick and healthy babies; and the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of healthy and sick newborns.
DISCUSSION


The BabySeq Project will provide empirical data about the risks, benefits and costs of newborn genomic sequencing and will inform policy decisions related to universal genomic screening of newborns.
TRIAL REGISTRATION


The study is registered in ClinicalTrials.gov Identifier: NCT02422511 . Registration date: 10 April 2015.",2018,"The ""BabySeq Project"" is a randomized trial that explores the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of healthy and sick newborns.
","['sick and healthy babies', 'healthy and sick newborns', 'newborns', ""Families of newborns are enrolled from Boston Children's Hospital and Brigham and Women's Hospital nurseries, and half are randomized to receive genomic sequencing and a report that includes monogenic disease variants, recessive carrier variants for childhood onset or actionable disorders, and pharmacogenomic variants""]",[],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0028660', 'cui_str': 'Nurseries, Hospital'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4277630', 'cui_str': 'Pharmacokinetic Genetic Variants'}]",[],[],,0.0236882,"The ""BabySeq Project"" is a randomized trial that explores the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of healthy and sick newborns.
","[{'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Holm', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA. ingrid.holm@childrens.harvard.edu.""}, {'ForeName': 'Pankaj B', 'Initials': 'PB', 'LastName': 'Agrawal', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Ceyhan-Birsoy', 'Affiliation': 'Laboratory for Molecular Medicine, Partners Healthcare Personalized Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Kurt D', 'Initials': 'KD', 'LastName': 'Christensen', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Fayer', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Frankel', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Casie A', 'Initials': 'CA', 'LastName': 'Genetti', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Joel B', 'Initials': 'JB', 'LastName': 'Krier', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'LaMay', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Harvey L', 'Initials': 'HL', 'LastName': 'Levy', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'McGuire', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Parad', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Park', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Pereira', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Rehm', 'Affiliation': 'Laboratory for Molecular Medicine, Partners Healthcare Personalized Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Talia S', 'Initials': 'TS', 'LastName': 'Schwartz', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Waisbren', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Yu', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Beggs', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA. Beggs@enders.tch.harvard.edu.""}]",BMC pediatrics,['10.1186/s12887-018-1200-1']
753,30644997,"A multicentre, randomized, split face and/or neck comparison of 308-nm excimer laser and 0·1% tacrolimus ointment for stable vitiligo plus intramuscular slow-releasing betamethasone for active vitiligo.",,2019,,['stable vitiligo plus intramuscular slow-releasing betamethasone for active vitiligo'],['308-nm excimer laser and 0·1% tacrolimus ointment'],[],"[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0392265', 'cui_str': 'Lasers, Excimer'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]",[],,0.0759076,,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of\xa0Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of\xa0Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'Department of\xa0Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of\xa0Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of\xa0Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology, The People's Hospital of Peking University, Beijing, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, The People's Hospital of Peking University, Beijing, China.""}, {'ForeName': 'X-H', 'Initials': 'XH', 'LastName': 'Gao', 'Affiliation': 'Department of\xa0Dermatology, The First Hospital of China Medical University, Shenyang, China.'}]",The British journal of dermatology,['10.1111/bjd.17630']
754,31646260,Letrozole as co-treatment agent in ovarian stimulation antagonist protocol in poor responders: A double-blind randomized clinical trial.,"Background


Ovarian stimulation (OS) for poor ovarian response (POR) patients is still a major challenge in assisted reproductive techniques. Aromatase inhibitors as co-treatment in antagonist protocol are suggested to these patients, but there are controversial reports.
Objective


To evaluate the effectiveness Letrozole (LZ) as adjuvant treatment in gonadotropin-releasing hormone (GnRH)-antagonist protocol in POR patients undergoing in vitro fertilization/ intracytoplasmic sperm injection cycles.
Materials and Methods


This double-blind randomized clinical trial was conducted in Arash women's hospital. One hundred sixty infertile women with POR based on Bologna criteria were allocated into two groups randomly: LZ + GnRH-antagonist (LA) and placebo + GnRH-antagonist (PA) groups. In the experimental group, the patients received 5 mg LZ on the first five days of OS with 150 IU of recombinant human follicle-stimulating hormone (rFSH) and 150 IUof human menopausal gonadotropin (HMG). The cycle outcomes were compared between groups.
Results


The total number of retrieved oocytes and the metaphase II oocytes in LA-treated group were significantly higher than those in the control group (p = 0.008, p = 0.002). The dosage of hMG used and the duration of OS and antagonist administration in LZ-treated group were significantly lower than those of the control group. The number of patients with no oocyte, in the control group, was higher than the LZ-treated group, and the clinical pregnancy rate in LA-treated group (25%) was higher than the control group (18%); however, the differences were not significant statistically.
Conclusion


Adding 5 mg of LZ to rFSH/hMG antagonist protocol may improve the in vitro fertilization/intracytoplasmic sperm injectioncycle outcome in POR patients.",2019,"The number of patients with no oocyte, in the control group, was higher than the LZ-treated group, and the clinical pregnancy rate in LA-treated group (25%) was higher than the control group (18%); however, the differences were not significant statistically.
","['POR patients', 'poor responders', 'POR patients undergoing in vitro fertilization/ intracytoplasmic sperm injection cycles', 'One hundred sixty infertile women with POR based on Bologna criteria', ""Arash women's hospital"", 'poor ovarian response (POR) patients']","['gonadotropin-releasing hormone (GnRH)-antagonist protocol', 'Letrozole', 'LZ + GnRH-antagonist (LA) and placebo + GnRH-antagonist (PA', 'recombinant human follicle-stimulating hormone (rFSH) and 150 IUof human menopausal gonadotropin (HMG', 'LZ', '\n\n\nOvarian stimulation (OS', 'Letrozole (LZ']","['clinical pregnancy rate', 'total number of retrieved oocytes and the metaphase II oocytes', 'vitro fertilization/intracytoplasmic sperm injectioncycle outcome', 'duration of OS and antagonist administration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016774', 'cui_str': 'Follicle Stimulating Hormone, Human'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",,0.115519,"The number of patients with no oocyte, in the control group, was higher than the LZ-treated group, and the clinical pregnancy rate in LA-treated group (25%) was higher than the control group (18%); however, the differences were not significant statistically.
","[{'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Department of Gynecology and ObstetricsArashWomen's HospitalTehran University of Medical Sciences Tehran Iran.""}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Lavasani', 'Affiliation': ""Infertility Ward Arash Women's Hospital Tehran University of Medical Sciences Tehran Iran.""}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Kashani', 'Affiliation': ""Infertility Ward Arash Women's Hospital Tehran University of Medical Sciences Tehran Iran.""}, {'ForeName': 'Maryam Farid', 'Initials': 'MF', 'LastName': 'Mojtahedi', 'Affiliation': ""Infertility Ward Arash Women's Hospital Tehran University of Medical Sciences Tehran Iran.""}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Yamini', 'Affiliation': ""IVF Department Embryology Lab Arash Women's Hospital Tehran University of Medical Sciences Tehran Iran.""}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i9.5101']
755,31640847,Effects of ankle position during static stretching for the hamstrings on the decrease in passive stiffness.,"Static stretching is frequently performed to improve flexibility of the hamstrings, although the ankle position during hamstring stretching has not been fully investigated. We investigated the effects of ankle position during hamstring stretching on the decrease in passive stiffness. Fourteen healthy men performed static stretching for the hamstrings with the ankle dorsiflexed and plantar-flexed in a randomized order on different days. The hip was passively flexed to the maximum angle which could be tolerated without stretch pain with the knee fully extended; this was maintained for 5 min, with 1-min stretching performed in 5 sessions. Final angles and passive stiffness were measured before and after stretching. The final angle was defined as that formed by the tibia and horizontal plane when the knee was passively extended from hip and knee angles at 90° flexion to the maximum extension angle which could be tolerated without stretch pain. Passive stiffness was determined by the slope of torque-angle curve during the measurement of the final angle. The final angle significantly increased after stretching with the ankle dorsiflexed and plantar-flexed, whereas passive stiffness significantly decreased only after stretching with the ankle planter-flexed. The results suggest that passive stiffness decreases after stretching with the ankle planter-flexed but not after stretching with the ankle dorsiflexed, although the range of joint motion increases regardless of the ankle position during 5-min stretching for the hamstrings. These results indicate that static stretching should be performed with the ankle plantar-flexed when aiming to decrease passive stiffness of the hamstrings.",2019,"The final angle significantly increased after stretching with the ankle dorsiflexed and plantar-flexed, whereas passive stiffness significantly decreased only after stretching with the ankle planter-flexed.",['Fourteen healthy men performed'],"['static stretching', 'Static stretching']","['Final angles and passive stiffness', 'passive stiffness', 'Passive stiffness']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",14.0,0.0170038,"The final angle significantly increased after stretching with the ankle dorsiflexed and plantar-flexed, whereas passive stiffness significantly decreased only after stretching with the ankle planter-flexed.","[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Nakao', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan. Electronic address: nakao.sayaka.37s@kyoto-u.jp.'}, {'ForeName': 'Tome', 'Initials': 'T', 'LastName': 'Ikezoe', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Saeki', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Japan; Research Fellow of the Japan Society for the Promotion of Science, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Umehara', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan; Research Fellow of the Japan Society for the Promotion of Science, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Ichihashi', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109358']
756,30058941,Specific effects of the Trier Social Stress Test on speech fluency in young and older adults.,"The notion that speech becomes less fluent during stressful speaking conditions has received little empirical test, and no research has tested this relationship in older adult participants. We analyzed speeches produced during the Trier Social Stress Test (TSST) or during a less stressful placebo (pTSST) version of the task. We measured young and older adults' speech fillers (e.g., um), unfilled pauses (at least 1 s in duration), and other disfluencies (e.g., repetitions, repairs). Neither young nor older adult participants rated themselves as having greater stress in the TSST than pTSST condition, but behavioral effects were obtained. Participants in the TSST condition produced more mid-phrase speech fillers and unfilled pauses than participants in the pTSST condition. Young adults produced more unfilled pauses than older adults overall, and older adults produced more mid-phrase fillers than young adults. Critically, age group interacted with experimental condition, such that older speakers produced disproportionately more mid-phrase fillers than young adults in the TSST compared to the pTSST condition. In sum, the negative effects of the TSST on fluency were generally similar across age, but this specific age-related increase in mid-phrase fillers indicates that older adults' word retrieval may have been particularly negatively affected. Findings are generally consistent with previous research and add to understanding of how factors internal to the speaker (i.e., demographic, personality, and cognitive variables) and factors external to the speaker (i.e., variables regarding the situation, context, or content of speech) combine to affect speech fluency.",2019,"Young adults produced more unfilled pauses than older adults overall, and older adults produced more mid-phrase fillers than young adults.","['Young adults', 'young and older adults', 'older adult participants', ""young and older adults' speech fillers (e.g., um), unfilled pauses (at least 1\xa0s in duration), and other disfluencies (e.g., repetitions, repairs""]","['Trier Social Stress Test', 'TSST', 'Trier Social Stress Test (TSST) or during a less stressful placebo (pTSST']","['mid-phrase speech fillers and unfilled pauses', 'speech fluency', 'older speakers produced disproportionately more mid-phrase fillers']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0600665', 'cui_str': 'Phrase'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",,0.0201161,"Young adults produced more unfilled pauses than older adults overall, and older adults produced more mid-phrase fillers than young adults.","[{'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Metz', 'Affiliation': 'a Department of Psychology , University of Colorado Colorado Springs , Colorado Springs , CO , USA.'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'James', 'Affiliation': 'a Department of Psychology , University of Colorado Colorado Springs , Colorado Springs , CO , USA.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2018.1503639']
757,30005584,Dialectical behavior therapy skills training affects defense mechanisms in borderline personality disorder: An integrative approach of mechanisms in psychotherapy.,"Objective:  Borderline personality disorder (BPD) is characterized by immature defense mechanisms. Dialectical behavior therapy (DBT) is an effective treatment for BPD. However, understanding the underlying mechanisms of change is still limited. Using a transtheoretical framework, we investigated the effect of DBT skills training on defense mechanisms.  Method:  In this randomized controlled trial, 16 of 31 BPD outpatients received DBT skills training adjunctive to individual treatment as usual (TAU), while the remaining 15 received only individual TAU. Pre-post changes of defense mechanisms, assessed with the Defense Mechanism Rating Scale, were compared between treatment conditions using ANCOVAs. Partial correlations and linear regressions were conducted to explore associations between defenses and symptom outcome.  Results:  Overall defense function improved significantly more in the skills training condition ( F (1, 28) = 4.57,  p  = .041). Borderline defenses decreased throughout skills training, but not throughout TAU only ( F (1, 28) = 5.09,  p  = .032). In the skills training condition, an increase in narcissistic defenses was associated with higher symptom scores at discharge ( β  = 0.58,  p  = .02).  Conclusions:  Although DBT does not explicitly target defense mechanisms, skills training may have favorable effects on defense function in BPD. Our findings contribute to an integrative understanding of mechanisms of change in BPD psychotherapy.",2019,"RESULTS


Overall defense function improved significantly more in the skills training condition (F(1, 28) = 4.57, p = .041).","['borderline personality disorder', '16 of 31 BPD outpatients received', 'Borderline personality disorder (BPD']","['Dialectical behavior therapy skills training', 'DBT skills training adjunctive to individual treatment as usual (TAU), while the remaining 15 received only individual TAU', 'DBT', 'Dialectical behavior therapy (DBT', 'DBT skills training']","['Defense Mechanism Rating Scale', 'Overall defense function', 'narcissistic defenses']","[{'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0011142', 'cui_str': 'Defense Mechanisms'}, {'cui': 'C0222045'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031843', 'cui_str': 'function'}]",31.0,0.0295063,"RESULTS


Overall defense function improved significantly more in the skills training condition (F(1, 28) = 4.57, p = .041).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Euler', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel , Basel , Switzerland.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Stalujanis', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel , Basel , Switzerland.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Allenbach', 'Affiliation': 'Psychiatric University Hospital (CHUV), University of Lausanne , Lausanne , Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Kolly', 'Affiliation': 'Psychiatric University Hospital (CHUV), University of Lausanne , Lausanne , Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'de Roten', 'Affiliation': 'Psychiatric University Hospital (CHUV), University of Lausanne , Lausanne , Switzerland.'}, {'ForeName': 'Jean-Nicolas', 'Initials': 'JN', 'LastName': 'Despland', 'Affiliation': 'Psychiatric University Hospital (CHUV), University of Lausanne , Lausanne , Switzerland.'}, {'ForeName': 'Ueli', 'Initials': 'U', 'LastName': 'Kramer', 'Affiliation': 'Psychiatric University Hospital (CHUV), University of Lausanne , Lausanne , Switzerland.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2018.1497214']
758,31619065,Do Infant Cleft Dimensions Have an Influence on Occlusal Relations? A Subgroup Analysis Within an RCT of Primary Surgery in Patients With Unilateral Cleft Lip and Palate.,"AIM


To investigate whether infant cleft dimensions, in a surgical protocol with early or delayed hard palate closure, influence occlusion before orthodontics.
DESIGN


Subgroup analysis within a randomized trial of primary surgery (Scandcleft).
SETTING


Tertiary health care. One surgical centre.
PATIENTS AND METHODS


A total of 122 unilateral cleft lip and palate infants received primary cheilo-rhinoplasty and soft palate closure at age 4 months and were randomized for hard palate closure at age 12 versus 36 months. A novel 3D analysis of cleft size and morphology was performed on digitized presurgical models. Occlusion was scored on 8-year models using the modified Huddarth-Bodenham (MHB) Index and the Goslon Yardstick.
MAIN OUTCOME MEASUREMENTS


Differences in MHB and Goslon scores among the 2 surgical groups adjusted for cleft size.
RESULTS


The crude analysis showed no difference between the 2 surgical groups in Goslon scores but a better MHB ( P  = .006) for the group who received delayed hard palate closure. When adjusting for the ratio between cleft surface and palatal surface (3D Infant Cleft Severity Ratio) and for posterior cleft dimensions at tuberosity level, the delayed hard palate closure group received 3.65 points better for MHB (confidence interval: 1.81; 5.48;  P  < .001) and showed a trend for reduced risk of receiving a Goslon of 4 or 5 ( P  = .052). For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group ( P  = .033).
CONCLUSIONS


Seen from an orthodontic perspective, when the soft palate is closed first, and the cleft is large, the timing of hard palate closure should be planned in relation to posterior cleft size.",2020,"For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group ( P  = .033).
","['122 unilateral cleft lip and palate infants received', 'Tertiary health care', 'Patients With Unilateral Cleft Lip and Palate']","['primary cheilo-rhinoplasty and soft palate closure at age 4 months and were randomized for hard palate closure', 'primary surgery (Scandcleft']","['Goslon scores', 'MHB and Goslon scores', 'Goslon score']","[{'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0030219', 'cui_str': 'Velum Palatinum'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",122.0,0.151436,"For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group ( P  = .033).
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Botticelli', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Küseler', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Marcusson', 'Affiliation': 'Maxillofacial Unit, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mølsted', 'Affiliation': 'Copenhagen Cleft Palate Center-University Hospital of Copenhagen-Denmark.'}, {'ForeName': 'Sven E', 'Initials': 'SE', 'LastName': 'Nørholt', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aarhus University Hospital-Denmark.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cattaneo', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Pedersen', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619875320']
759,30138239,Effect of 2- vs. 3-Minute Interrepetition Rest Period on Maximal Clean Technique and Performance.,"Ammar, A, Riemann, BL, Abdelkarim, O, Driss, T, and Hökelmann, A. Effect of 2- vs. 3-minute interrepetition rest period on maximal clean technique and performance. J Strength Cond Res 34(9): 2548-2556, 2020-Currently, it is widely accepted that adopting a long rest period (3-5 minutes) during maximal strength and power exercise is of importance in reducing acute fatigue and maintaining power and technique proficiency. However, despite the fact that weightlifting is an example of maximal strength exercise, only 2 minutes are officially allowed when athletes attempt 2 successive lifts. The purpose of this study was to compare 3- vs. 2-minute intermaximal repetition rest periods (IMRRPs) on performance, rate of perceived exertion (RPE), technical efficiency, and power production during 2 successive maximal repetitions of clean & jerk (C&J). Nine elite weightlifters (age: 24.4 ± 3.6 years, body mass: 77.2 ± 7.1 kg, height 176.0 ± 6.4 cm, and 1 repetition maximum C&J: 170.0 ± 5.0 kg) performed 2 separate testing sessions using 2-minute IMRRP (IMRRP-2) and 3-minute IMRRP (IMRRP-3), in a randomized order, while barbell kinematics and kinetics were recorded. Results showed that the longer IMRRP-3 minutes led to the maintenance of clean technique (from the first to the second repetition) evidenced by a 1.86% lower decline in peak vertical displacement (p = 0.03) and attenuation of increased peak horizontal displacements with a 1.74% (p = 0.03) less backward movement during the first pull, a 3.89% (p = 0.008) less forward movement during the second pull, and a 4.7% (p = 0.005) less backward movement during the catch phase. In addition, attenuation of peak velocity (2.22%; p = 0.02), peak vertical ground reaction force (1.70%; p = 0.03), and peak power (2.14%; p = 0.02) declines were shown using IMRRP-3 compared with IMRRP-2. Increasing IMRRP from 2 to 3 minutes was also shown to decrease RPE values (8.02%; p = 0.008) and to enhance supramaximal C&J performance (1.55%; p = 0.003). The results of this study suggest 3 minutes to be the most advantageous IMRRP in terms of maintaining technical efficiency, power output, reducing fatigue perception, and enhancing performance in elite weightlifters.",2020,"In addition, attenuation of peak velocity (2.22%; p = 0.02), peak vertical ground reaction force (1.70%; p = 0.03), and peak power (2.14%; p = 0.02) declines were shown using IMRRP-3 compared with IMRRP-2.","['Nine elite weightlifters (age: 24.4 ± 3.6 years, body mass: 77.2 ± 7.1 kg, height 176.0 ± 6.4 cm, and 1 repetition maximum C&J: 170.0 ± 5.0 kg) performed 2', 'elite weightlifters']","['J Strength Cond Res XX(X', '2-minute intermaximal repetition rest periods (IMRRPs', 'separate testing sessions using 2-minute IMRRP (IMRRP-2) and 3-minute IMRRP (IMRRP-3']","['enhance supramaximal C&J performance', 'Maximal Clean Technique and Performance', 'peak horizontal displacements', 'performance, rate of perceived exertion (RPE), technical efficiency, and power production during 2 successive maximal repetitions of clean & jerk (C&J', 'Riemann, BL, Abdelkarim, O, Driss, T, and Hökelmann, A. Effect of 2- vs. 3-minute interrepetition rest period on maximal clean technique and performance', 'peak vertical displacement', 'attenuation of peak velocity', 'peak vertical ground reaction force', 'backward movement', 'technical efficiency, power output, reducing fatigue perception', 'RPE values']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0033268'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1704276', 'cui_str': 'Spasmodic movement (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0282401,"In addition, attenuation of peak velocity (2.22%; p = 0.02), peak vertical ground reaction force (1.70%; p = 0.03), and peak power (2.14%; p = 0.02) declines were shown using IMRRP-3 compared with IMRRP-2.","[{'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Research Unit (EM2S), High Institute of Sport and Physical Education, Sfax University, Sfax, Tunisia.'}, {'ForeName': 'Bryan L', 'Initials': 'BL', 'LastName': 'Riemann', 'Affiliation': 'Biodynamics and Human Performance Center, Georgia Southern University, Savannah, Georgia.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Abdelkarim', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Research Center on Sport and Movement (EA 2931), UFR STAPS, University of Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hökelmann', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002785']
760,30091945,"Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group.","Purpose Intermediate-risk rhabdomyosarcoma (RMS) includes patients with either nonmetastatic, unresected embryonal RMS (ERMS) with an unfavorable primary site or nonmetastatic alveolar RMS (ARMS). The primary aim of this study was to improve the outcome of patients with intermediate-risk RMS by substituting vincristine and irinotecan (VI) for half of vincristine, dactinomycin, and cyclophosphamide (VAC) courses. All patients received a lower dose of cyclophosphamide and earlier radiation therapy than in previous trials. Patients and Methods Patients were randomly assigned at study entry to either VAC (cumulative cyclophosphamide dose, 16.8 g/m 2 ) or VAC/VI (cumulative cyclophosphamide dose, 8.4 g/m 2 ) for 42 weeks of therapy. Radiation therapy started at week 4, with individualized local control plans permitted for patients younger than 24 months. The primary study end point was event-free survival (EFS). The study design had an 80% power (5% one-sided α-level) to detect an improved long-term EFS from 65% (with VAC) to 76% (with VAC/VI). Results A total of 448 eligible patients were enrolled in the study. At a median follow-up of 4.8 years, the 4-year EFS was 63% with VAC and 59% with VAC/VI ( P = .51), and 4-year overall survival was 73% for VAC and 72% for VAC/VI ( P = .80). Within the ARMS and ERMS subgroups, no difference in outcome by treatment arm was found. Severe hematologic toxicity was less common with VAC/VI therapy. Conclusion The addition of VI to VAC did not improve EFS or OS for patients with intermediate-risk RMS. VAC/VI had less hematologic toxicity and a lower cumulative cyclophosphamide dose, making VAC/VI an alternative standard therapy for intermediate-risk RMS.",2018,"Within the ARMS and ERMS subgroups, no difference in outcome by treatment arm was found.","['448 eligible patients were enrolled in the study', 'patients with intermediate-risk RMS', 'patients with intermediate-risk RMS by substituting', 'patients with either nonmetastatic, unresected embryonal RMS (ERMS) with an unfavorable primary site or nonmetastatic alveolar RMS (ARMS', 'Intermediate-Risk Rhabdomyosarcoma']","['VAC (cumulative cyclophosphamide', 'VAC/VI (cumulative cyclophosphamide', 'cyclophosphamide and earlier radiation therapy', 'Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide', 'vincristine and irinotecan (VI) for half of vincristine, dactinomycin, and cyclophosphamide (VAC) courses']","['hematologic toxicity', '4-year EFS', 'event-free survival (EFS', '4-year overall survival', 'Severe hematologic toxicity', 'EFS or OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",448.0,0.0725006,"Within the ARMS and ERMS subgroups, no difference in outcome by treatment arm was found.","[{'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Carola A S', 'Initials': 'CAS', 'LastName': 'Arndt', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bomgaars', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Donaldson', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hayes-Jordan', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'McCarville', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Jeannine S', 'Initials': 'JS', 'LastName': 'McCune', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'McCowage', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Million', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Carol D', 'Initials': 'CD', 'LastName': 'Morris', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Parham', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Rudzinski', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Margarett', 'Initials': 'M', 'LastName': 'Shnorhavorian', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Stephen X', 'Initials': 'SX', 'LastName': 'Skapek', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Teot', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Wolden', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Torunn I', 'Initials': 'TI', 'LastName': 'Yock', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Meyer', 'Affiliation': ""Douglas S. Hawkins, Erin R. Rudzinski, and Margarett Shnorhavorian, Seattle Children's Hospital, Seattle, WA; Yueh-Yun Chi and Jing Tian, University of Florida, Gainesville, FL; James R. Anderson, Merck Research Laboratories, North Wales, PA; Carola A.S. Arndt, Mayo Clinic, Rochester, MN; Lisa Bomgaars, Texas Children's Hospital; Andrea Hayes-Jordan, MD Anderson Cancer Center, Houston; Stephen X. Skapek, University of Texas Southwestern, Dallas, TX; Sarah S. Donaldson, Lynn Million, and Sheri L. Spunt, Stanford University School of Medicine, Stanford; Leo Mascarenhas and David M. Parham, Children's Hospital of Los Angeles, Los Angeles; Jeannine S. McCune, City of Hope, Duarte, CA; Mary Beth McCarville, St Jude Children's Research Hospital, Memphis, TN; Geoff McCowage, Children's Hospital at Westmead, Westmead, New South Wales, Australia; Carol D. Morris, Johns Hopkins University, Baltimore, MD, David A. Rodeberg, East Carolina University, Greenville, NC; Lisa A. Teot, Boston Children's Hospital; Torunn I. Yock, Massachusetts General Hospital, Boston, MA; Suzanne Wolden, Memorial Sloan Kettering Cancer Center, New York, NY; and William H. Meyer, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.77.9694']
761,30027145,Granulocyte-colony stimulating factor may improve pregnancy outcome in patients with history of unexplained recurrent implantation failure: An RCT.,"Background


Family of colony-stimulating factors (CSF) have an essential role on early cross talk between embryo and uterine endometrium.
Objective


The aim of this study was to evaluate the effects of the single dose of Granulocyte-CSF (G-CSF) injection on clinical outcome of assisted reproductive technology cycle in patients with repeated implantation failures.
Materials and Methods


This randomized control trial study was performed on 52 infertile women who referred to the clinic with the history of more than three previous In vitro fertilization/Intracytoplasmic sperm injection-embryo transfer failures. All patients were stimulated with standard long protocol. All embryos were transferred on day five in blastocyst stage in both groups. The treated group received 300 µg (0.5 ml) recombinant human G-CSF subcutaneously which was injected 30 min before blastocyst embryo transfer.
Results


There was not statistically significant differences in abortion rate in G-CSF and control group (p=0.09). G-CSF treated group showed higher clinical pregnancy rate in comparison with control group (56.2% vs. 40.0%) but it was not statistically significant (p=0.09). Although live birth rate in G-CSF group was higher than control group (53.1% vs. 35.0%) but there wasn't statistically significant difference in the overall live birth rate between the two groups (p=0.10). G-CSF group had a twin pregnancies while in control group there was no twin pregnancy.
Conclusion


Our result demonstrates the possibility that pregnancy outcome is better in women with repeated unexplained In vitro fertilization failure who are treated with G-CSF.",2018,There was not statistically significant differences in abortion rate in G-CSF and control group (p=0.09).,"['52 infertile women who referred to the clinic with the history of more than three previous', 'patients with repeated implantation failures', 'women with repeated unexplained', 'patients with history of unexplained recurrent implantation failure']","['Granulocyte-CSF (G-CSF) injection', 'G-CSF', 'recombinant human G-CSF', 'Granulocyte-colony stimulating factor', '\n\n\nFamily of colony-stimulating factors (CSF']","['pregnancy outcome', 'live birth rate', 'overall live birth rate', 'clinical pregnancy rate', 'abortion rate']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}]",52.0,0.0807007,There was not statistically significant differences in abortion rate in G-CSF and control group (p=0.09).,"[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Arefi', 'Affiliation': 'Genetics and In Vitro Assisted Reproductive (GIVAR) Center, Erfan Hospital, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Fazeli', 'Affiliation': 'Department of Anatomy and Reproductive Biology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Manijeh', 'Initials': 'M', 'LastName': 'Esfahani', 'Affiliation': 'Genetics and In Vitro Assisted Reproductive (GIVAR) Center, Erfan Hospital, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Borhani', 'Affiliation': 'School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Yamini', 'Affiliation': 'IVF Center, Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Genetics and In Vitro Assisted Reproductive (GIVAR) Center, Erfan Hospital, Tehran, Iran.'}, {'ForeName': 'Fattaneh', 'Initials': 'F', 'LastName': 'Farifteh', 'Affiliation': 'Genetics and In Vitro Assisted Reproductive (GIVAR) Center, Erfan Hospital, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
762,29766148,Endogenous luteinizing hormone concentration and IVF outcome during ovarian stimulation in fixed versus flexible GnRH antagonist protocols: An RCT.,"Background


Luteinizing hormone (LH) is essential for normal follicular development and oocyte maturation. In particular, fluctuations of LH during the follicular phase have a significant impact on morphological and functional changes of the oocyte and determine its meiotic status and ability to be fertilized.
Objective


This prospective randomized controlled trial examined effects of endogenous follicular phase LH levels on oocyte maturity and IVF outcomes in fixed vs. flexible in vitro fertilization.
Materials and Methods


Normo-ovulatory women age <39 yr (n=213) were randomized to fixed or flexible gonadotrophin-releasing hormone (GnRH) antagonist protocols. Follicular phase LH, estradiol, and progesterone profiles were measured. Oocytes retrieved, implantation rate, and pregnancy rate were compared between the two groups.
Results


LH profiles were similar in both protocols. A lower trend of LH values at the end of ovarian stimulation correlated significantly with a higher pregnancy rate, regardless of protocol (p=0.02). Estradiol levels were statistically different with respect to time points within treatment groups (p<0.0001), but not between groups (p=0.43), or pregnancy outcomes (p=0.2595). Progesterone profiles were similar between groups. No differences were found in retrieved oocytes numbers, fertilization rate or embryos obtained. Significantly, younger age and a higher number of antral follicles were correlated with positive results.
Conclusion


Fixed and flexible GnRH antagonist protocols did not produce an oscillation of endogenous LH values correlated to the outcome of ovarian stimulation.",2018,"No differences were found in retrieved oocytes numbers, fertilization rate or embryos obtained.",['Materials and Methods\n\n\nNormo-ovulatory women age <39 yr'],"['\n\n\nLuteinizing hormone (LH', 'flexible gonadotrophin-releasing hormone (GnRH) antagonist protocols', 'endogenous follicular phase LH levels']","['retrieved oocytes numbers, fertilization rate or embryos obtained', 'number of antral follicles', 'oocyte maturity and IVF outcomes', 'Endogenous luteinizing hormone concentration and IVF outcome', 'Follicular phase LH, estradiol, and progesterone profiles', 'implantation rate, and pregnancy rate', 'Estradiol levels', 'Progesterone profiles', 'oscillation of endogenous LH values', 'LH values']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Follicular Phase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Follicular Phase'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",213.0,0.201293,"No differences were found in retrieved oocytes numbers, fertilization rate or embryos obtained.","[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Depalo', 'Affiliation': 'Department of Obstetrics-Gynecology-Neonatology and Anesthesiology, Unit of Medically Assisted Reproduction and Gametes Cryopreservation, University Hospital of Bari, Bari, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Trerotoli', 'Affiliation': 'Department of Biomedical and Human Oncological Science (DIMO), 2 Unit of Obstetrics and Gynecology, University of Bari, Bari, Italy.'}, {'ForeName': 'Annarosa', 'Initials': 'A', 'LastName': 'Chincoli', 'Affiliation': 'Department of Obstetrics-Gynecology-Neonatology and Anesthesiology, Unit of Medically Assisted Reproduction and Gametes Cryopreservation, University Hospital of Bari, Bari, Italy.'}, {'ForeName': 'Margherita Patrizia', 'Initials': 'MP', 'LastName': 'Vacca', 'Affiliation': 'Department of Obstetrics-Gynecology-Neonatology and Anesthesiology, Unit of Medically Assisted Reproduction and Gametes Cryopreservation, University Hospital of Bari, Bari, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Lamanna', 'Affiliation': ""Consultant Gynaecologist and IVF Specialist, London Women's Clinic, London, UK.""}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Cicinelli', 'Affiliation': 'Department of Obstetrics-Gynecology-Neonatology and Anesthesiology, Unit of Medically Assisted Reproduction and Gametes Cryopreservation, University Hospital of Bari, Bari, Italy.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
763,29942933,Pregnancy outcome in delayed start antagonist versus microdose flare GnRH agonist protocol in poor responders undergoing IVF/ICSI: An RCT.,"Background


Over the years, many article on different aspects of pathogenesis and management of poor ovarian responders have been published but there is no clear guideline for treating themyet.
Objective


This study was designated to compare the effectiveness of a delayed start protocol with gonadotropin-releasing hormone (GnRH) antagonist and microdose flare-up GnRH agonist protocol in poor ovarian responders.
Materials and Methods


This randomized clinical trial consisted of 100 poor ovarian responder women in assisted reproductive technologies cycles. They were divided randomly in delayed-start antagonist protocol (with estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation) and microdose flare-up GnRH agonist protocol. The main outcome was clinical pregnancy rate and second outcome was the number of retrieved oocytes, mature oocytes, 2PN number, fertilization rate, and implantation rate.
Results


Fertilization rate, clinical pregnancy rate, and ongoing pregnancy rates were not significantly different between the two studied protocols. Number of retrieved oocytes (5.10±3.41 vs. 3.08±2.51) with p=0.002, mature oocytes (4.32±2.69 vs. 2.34±1.80) with p=0.003, number of 2PN (3.94±1.80 vs. 2.20±1.01) with p=0.001 and implantation rate (19.40% vs. 10.30%) with p=0.022 were significantly higher in delayed antagonist group.
Conclusion


The delayed-start protocol can improve ovarian response in poor responders by stimulating and synchronizing follicle development.",2018,"Number of retrieved oocytes (5.10±3.41 vs. 3.08±2.51) with p=0.002, mature oocytes (","['poor responders undergoing IVF', '100 poor ovarian responder women in assisted reproductive technologies cycles', 'poor ovarian responders']","['delayed-start antagonist protocol (with estrogen priming followed by early follicular-phase GnRH antagonist treatment', 'ICSI', 'gonadotropin-releasing hormone (GnRH) antagonist and microdose flare-up GnRH agonist protocol']","['Fertilization rate, clinical pregnancy rate, and ongoing pregnancy rates', 'Number of retrieved oocytes', 'number of 2PN', 'implantation rate', 'clinical pregnancy rate and second outcome was the number of retrieved oocytes, mature oocytes, 2PN number, fertilization rate, and implantation rate', 'ovarian response']","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technology'}]","[{'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Follicular Phase'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}]",100.0,0.297913,"Number of retrieved oocytes (5.10±3.41 vs. 3.08±2.51) with p=0.002, mature oocytes (","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Nosrat', 'Initials': 'N', 'LastName': 'Neghab', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Naghshineh', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
764,31646414,Near-infrared spectroscopy for assessing microcirculation during laparoscopic gynaecological surgery under combined spinal-general anaesthesia or general anaesthesia alone: a randomised controlled trial.,"While pneumoperitoneum causes negative macrohaemodynamic effects, much less is known about microcirculatory effects of different anaesthetic techniques and laparoscopy. Therefore, we aimed to explore microcirculatory effects of combined spinal-general anaesthesia and laparoscopy, as measured by near-infrared spectroscopy over forearm and calf muscles utilising a 3-min ischemic challenge. Patients (n = 102) undergoing elective laparoscopic gynaecological surgery were randomised to receive general anaesthesia alone or in combination with high-dose or low-dose spinal analgesia (levobupivacaine 7.5 mg or 3.75 mg, respectively, plus sufentanil 2.5 μg). Primary outcomes were near-infrared spectroscopy derived parameters before general anaesthesia induction, 5 min after tracheal intubation, and 15 min after pneumoperitoneum commencement. General anaesthesia resulted in impaired post-ischaemic recovery rate in the forearm (p < 0.001, within all groups), which improved during laparoscopy. For the calf, before general anaesthesia induction, high and low dose spinal analgesia significantly slowed the post-ischaemic recovery compared to control (34 ± 16% min -1  and 36 ± 13% min -1  vs. 52 ± 27% min -1 , respectively; p = 0.002 and p = 0.006). General anaesthesia abolished differences between the groups (24 ± 14% min -1  and 25 ± 12% min -1  vs. 27 ± 18% min -1 ), while during laparoscopy high-dose spinal analgesia further reduced the post-ischaemic recovery compared to low-dose spinal and control groups (p = 0.023 and p = 0.040, respectively). During gynaecological laparoscopy patients show impaired calf but maintain forearm microcirculatory function, regardless of the anaesthetic technique. Reduction in post-ischaemic recovery with high-dose spinal analgesia is explained by its sympatholytic effects: number of perfused capillaries is increased, leading to a haemodynamically more favourable state. Blood pressure is positively correlated with the post-ischaemic recovery rate in vascular beds not affected by spinal analgesia.",2020,"General anaesthesia resulted in impaired post-ischaemic recovery rate in the forearm (p < 0.001, within all groups), which improved during laparoscopy.",['Patients (n\u2009=\u2009102) undergoing elective laparoscopic gynaecological surgery'],"['general anaesthesia alone or in combination with high-dose or low-dose spinal analgesia (levobupivacaine 7.5\xa0mg or 3.75\xa0mg, respectively, plus sufentanil 2.5\xa0μg', 'laparoscopic gynaecological surgery under combined spinal-general anaesthesia or general anaesthesia alone', 'combined spinal-general anaesthesia and laparoscopy']","['Blood pressure', 'near-infrared spectroscopy derived parameters before general anaesthesia induction, 5\xa0min after tracheal intubation, and 15\xa0min', 'post-ischaemic recovery rate', 'post-ischaemic recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]",,0.0790459,"General anaesthesia resulted in impaired post-ischaemic recovery rate in the forearm (p < 0.001, within all groups), which improved during laparoscopy.","[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Zdravkovic', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Maribor, Slovenia. markozdravkovic@gmail.com.'}, {'ForeName': 'Matej', 'Initials': 'M', 'LastName': 'Podbregar', 'Affiliation': 'Department of Intensive Care, General Hospital Celje, Celje, Slovenia.'}, {'ForeName': 'Mirt', 'Initials': 'M', 'LastName': 'Kamenik', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Maribor, Slovenia.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00406-9']
765,31630358,Effects of TAT-SOD at Acupoints on Essential Hypertension by Monitoring Meridians Electrical Potential.,"OBJECTIVES


To investigate the effect on essential hypertension of the topical application of TAT-Cu, Zn-superoxide dismutase (TAT-SOD) at left acupoint Zusanli (ST 36), and to observe whether the change of electrical potential difference (EPD) can be related to the change of blood pressure.
METHODS


Sixteen patients with essential hypertension and 16 healthy subjects were included in the study. EPD between the left acupoints of Yanglingquan (GB 34) and Qiuxu (GB 40) was firstly screened out for the EPD detection. An intracellular superoxide quenching enzyme, TAT-SOD, was topically applied to the acupoint ST 36 within an area of 1 cm 2  once a day, and the influence on EPD was investigated. The dosage applied to TAT-SOD group (n=8) was 0.2 mL of 3000 U/mL TAT-SOD cream prepared by adding purified TAT-SOD to a vehicle cream, while placebo group (n=8) used the vehicle cream instead. The left acupoints of Yanglingquan (GB 34) and Qiuxu (GB 40) were selected for EPD measurement after comparing EPD readings between 5 acupoints on each of all 12 meridians.
RESULTS


EPDs between the left acupoints of GB 34 and GB 40 for 16 patients of essential hypertension and 16 healthy subjects were 44.9±6.4 and 5.6±0.9 mV, respectively. Daily application of TAT-SOD for 15 days at ST 36 of essential hypertension patients significantly decreased systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 179.6 and 81.5 mm Hg to 153.1 and 74.1 mm Hg, respectively. Responding to the change in blood pressure, EPD between the left acupoints of GB 34 and GB 40 also declined from 44.4 to 22.8 mV with the same trend. No change was observed with SBP, DBP and EPD between the left acupoints of GB 34 and GB 40 with the daily application of the placebo cream.
CONCLUSION


Enzymatic scavenging of the intracellular superoxide at ST 36 proved to be effective in decreasing SBP and DBP. The results reconfirm the involvement of superoxide anions and its transportation along the meridians, and demonstrate that EPD between acupoints may be an indicator to reflect its functioning status. Moreover, preliminary results suggest a close correlation between EPD and blood pressure readings, implying a possibility of using EPD as a sensitive parameter for blood pressure and to monitor the effect of antihypertensive treatment.",2020,"No change was observed with SBP, DBP and EPD between the left acupoints of GB 34 and GB 40 with the daily application of the placebo cream.
","['Sixteen patients with essential hypertension and 16 healthy subjects were included in the study', '16 patients of essential hypertension and 16 healthy subjects']","['placebo', 'TAT-Cu, Zn-superoxide dismutase (TAT-SOD', 'TAT-SOD', 'TAT-SOD at Acupoints']","['SBP and DBP', 'blood pressure', 'SBP, DBP and EPD', 'EPD and blood pressure readings', 'systolic blood pressure (SBP) and diastolic blood pressure (DBP', 'blood pressure, EPD']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",36.0,0.0282829,"No change was observed with SBP, DBP and EPD between the left acupoints of GB 34 and GB 40 with the daily application of the placebo cream.
","[{'ForeName': 'Jing-Ke', 'Initials': 'JK', 'LastName': 'Guo', 'Affiliation': 'Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences/Zhejiang Gongshang University Joint Centre for Food and Nutrition Research, Zhejiang Gongshang University, Hangzhou, 310035, China.'}, {'ForeName': 'Jin-Sen', 'Initials': 'JS', 'LastName': 'Xu', 'Affiliation': 'Acupuncture College, Fujian University of Traditional Chinese Medicine, Fuzhou, 350003, China.'}, {'ForeName': 'Tian-Bao', 'Initials': 'TB', 'LastName': 'Chen', 'Affiliation': ""Natural Drug Discovery Group, School of Pharmacy, Queen's University, Belfast, BT97BL, UK.""}, {'ForeName': 'Ming-Ming', 'Initials': 'MM', 'LastName': 'Xu', 'Affiliation': 'College of Oceanology and Food Science, Quanzhou Normal University, Quanzhou, Fujian, 362000, China.'}, {'ForeName': 'Shu-Tao', 'Initials': 'ST', 'LastName': 'Liu', 'Affiliation': 'College of Biological Science and Technology, Fuzhou University, Fuzhou, 350108, China.'}, {'ForeName': 'Chao-Xin', 'Initials': 'CX', 'LastName': 'Zhang', 'Affiliation': 'Guangzhou Halcyon Technology Ltd., Guangzhou, 510630, China.'}, {'ForeName': 'Li-Jing', 'Initials': 'LJ', 'LastName': 'Ke', 'Affiliation': 'Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences/Zhejiang Gongshang University Joint Centre for Food and Nutrition Research, Zhejiang Gongshang University, Hangzhou, 310035, China.'}, {'ForeName': 'Jian-Wu', 'Initials': 'JW', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences/Zhejiang Gongshang University Joint Centre for Food and Nutrition Research, Zhejiang Gongshang University, Hangzhou, 310035, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Institute of Food Science and Technology, Chinese Academy of Agricultural Sciences, Beijing, 100193, China.'}, {'ForeName': 'Ping-Fan', 'Initials': 'PF', 'LastName': 'Rao', 'Affiliation': 'Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences/Zhejiang Gongshang University Joint Centre for Food and Nutrition Research, Zhejiang Gongshang University, Hangzhou, 310035, China. pingfan.rao@gmail.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-019-3173-9']
766,29675488,Trans dermal estrogen (oestrogel) for endometrial preparation in freeze embryo transfer cycle: An RCT.,"Background


Estrogen and progesterone are two crucial factors for endometrial preparation in frozen embryo transfer (FET) cycles. Studies assessing different forms of estradiol in FET have published already but literature lacks enough surveys on transdermal estrogen application in reproductive medicine.
Objective


To investigate the effects of trans dermal estrogen (Oestrogel) on pregnancy rates in patients that candidate for FET cycle.
Materials and Methods


In this randomized clinical trial, 100 women undergoing FET cycles referred to Imam Khomeeini Hospital were enrolled in two groups, randomly. Group I received 8 mg/day estradiol valerate (E2 tablet) orally and group II were treated with 6 mg/day transdermal oestrogel gel after suppression with gonadotropin releasing hormone agonist. In both groups medication were started in the first day of menstruation cycle and continued until endometrial thickness reached 8 mm. Pregnancy rates (chemical, clinical, and ongoing), abortion rate, live birth rate, and frequency of complications were compared between two groups.
Results


Chemical and clinical pregnancy rates were not significantly different between two groups (p=0.384). The abortion rate was significantly lower in group II than group I (p=0.035). Ongoing pregnancy and the live birth rates were significantly higher in group II (p=0.035). The rate of complication was not different in two groups.
Conclusion


Oestrogel seems to enhance ongoing pregnancy and live birth rates in comparison to estradiol valerate tablet.",2018,Chemical and clinical pregnancy rates were not significantly different between two groups (p=0.384).,"['patients that candidate for FET cycle', '100 women undergoing FET cycles referred to Imam Khomeeini Hospital were enrolled in two groups, randomly']","['\n\n\nEstrogen and progesterone', 'estradiol valerate (E2 tablet) orally and group II were treated with 6 mg/day transdermal oestrogel gel', 'gonadotropin releasing hormone agonist', 'estradiol valerate tablet', 'trans dermal estrogen (Oestrogel', 'Trans dermal estrogen (oestrogel']","['rate of complication', 'live birth rates', 'Chemical and clinical pregnancy rates', 'ongoing pregnancy and live birth rates', 'abortion rate', 'Pregnancy rates (chemical, clinical, and ongoing), abortion rate, live birth rate, and frequency of complications', 'pregnancy rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0059623', 'cui_str': 'estradiol valerate'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",100.0,0.0778027,Chemical and clinical pregnancy rates were not significantly different between two groups (p=0.384).,"[{'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Shahrokh Tehraninejad', 'Affiliation': 'Health Reproductive Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kabodmehri', 'Affiliation': 'Health Reproductive Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Batol', 'Initials': 'B', 'LastName': 'Hosein Rashidi', 'Affiliation': 'Health Reproductive Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Jafarabadi', 'Affiliation': 'Health Reproductive Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Keikha', 'Affiliation': 'Health Reproductive Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masomeh', 'Initials': 'M', 'LastName': 'Masomi', 'Affiliation': 'Health Reproductive Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fedieh', 'Initials': 'F', 'LastName': 'Hagholahi', 'Affiliation': 'Health Reproductive Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
767,29642095,"Efficacy of Intra-articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.","OBJECTIVE


Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
DESIGN


A randomized, double-blind, controlled clinical trial.
PATIENTS


The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
INTERVENTIONS AND MAIN OUTCOME MEASURES


Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
CONCLUSIONS


These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.",2018,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","['Knee Osteoarthritis', '100 patients']","['HA [PNs associated with HA (PNHA', 'Hyaluronic acid (HA', 'PNHA or HA alone', 'Hyaluronic Acid Versus Hyaluronic Acid Alone']","['Knee Society Score total score and pain item', 'knee function and pain', 'adverse events', 'WOMAC score', 'Knee Society Score and WOMAC scores', 'Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039097', 'cui_str': 'Synovia'}]",100.0,0.245541,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","[{'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Dallari', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sabbioni', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Nicolandrea', 'Initials': 'N', 'LastName': 'Del Piccolo', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carubbi', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Veronesi', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Torricelli', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000569']
768,29493708,Can Robots Accelerate the Learning Curve for Surgical Training? An Analysis of Residents and Medical Students.,"Surgical traineeship has traditionally been based on a master apprentice model where learning takes place in the operating theatre. This approach has changed over the past few years with greater emphasis on surgical training taking place within the surgical skills laboratory. We developed a high fidelity simulator, the Image-guided Robotic Assisted Surgical simulator (IRAS) with an incorporated robotic guidance feature. The robot system is developed to mimic the process of an experienced surgeon physically holding a trainee's hands to demonstrate maneuvering of the laparoscopic instruments. We aimed to assess the efficacy of incorporating robotic guidance into this high fidelity surgical simulator. Forty-two participants (13 surgical residents and 29 medical students) were recruited. Participants had one practice run for familiarisation and subsequently performed the virtual laparoscopic cholecystectomy (LC) once. Among the medical students, they were ransomised to either a control or intervention group. They were tasked to perform a second- and third-timed LC assessment. Participants were asked to rate the simulator using a 5-point Likert scale Questionnaire. IRAS rated favourably in hand-eye coordination and training bimanual dexterity (mean score: 4.1 and 4.0 among students, 3.4 and 3.4 among residents) though it faired suboptimally in realism. At baseline, residents were statistically faster compared to students (overall time: 418.9 vs 586.8 seconds,  P  = 0.001). Participants randomised to the intervention group consistently scored better. However, their overall time were not statistically significant from the control group. The robotic guidance capability of the IRAS is a key advantage of this simulator platform over the conventional platform.",2018,"At baseline, residents were statistically faster compared to students (overall time: 418.9 vs 586.8 seconds,  P  = 0.001).","['Participants had one practice run for familiarisation and subsequently performed the virtual laparoscopic cholecystectomy (LC) once', 'Forty-two participants (13 surgical residents and 29 medical students', 'Residents and Medical Students']","['Image-guided Robotic Assisted Surgical simulator (IRAS', 'robotic guidance']",['5-point Likert scale Questionnaire'],"[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",42.0,0.0294953,"At baseline, residents were statistically faster compared to students (overall time: 418.9 vs 586.8 seconds,  P  = 0.001).","[{'ForeName': 'Joel Wl', 'Initials': 'JW', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, National University Health System, Singapore.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Kyaw Kyar', 'Initials': 'KK', 'LastName': 'Toe', 'Affiliation': ''}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Stephen Ky', 'Initials': 'SK', 'LastName': 'Chang', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
769,31533277,Medical Outcomes in Women Who Became Pregnant after Vaccination with a Virus-Like Particle Experimental Vaccine against Influenza A (H1N1) 2009 Virus Tested during 2009 Pandemic Outbreak.,"The clinical effects and immunological response to the influenza vaccine in women who later become pregnant remain to be thoroughly studied. Here, we report the medical outcomes of 40 women volunteers who became pregnant after vaccination with an experimental virus-like particle (VLP) vaccine against pandemic influenza A(H1N1)2009 (influenza A(H1N1)pdm09) and their infants. When included in the VLP vaccine trial, none of the women were pregnant and were randomly assigned to one of the following groups: (1) placebo, (2) 15 μg dose of VLP vaccine, or (3) 45 μg dose of VLP vaccine. These 40 women reported becoming pregnant during the follow-up phase after receiving the placebo or VLP vaccine. Women were monitored throughout pregnancy and their infants were monitored until one year after birth. Antibody titers against VLP were measured in the mothers and infants at delivery and at six months and one year after birth. The incidence of preeclampsia, fetal death, preterm delivery, and premature rupture of membranes was similar among groups. All vaccinated women and their infants elicited antibody titers (≥1:40). Women vaccinated prior to pregnancy had no adverse events that were different from the nonvaccinated population. Even though this study is limited by the sample size, the results suggest that the anti-influenza A(H1N1)pdm09 VLP experimental vaccine applied before pregnancy is safe for both mothers and their infants.",2019,Antibody titers against VLP were measured in the mothers and infants at delivery and at six months and one year after birth.,"['women who later become pregnant remain', 'Who Became Pregnant after Vaccination with a Virus-Like Particle Experimental Vaccine against Influenza A (H1N1) 2009', 'Women', '40 women volunteers who became pregnant after vaccination with an experimental virus-like particle (VLP) vaccine against pandemic influenza A(H1N1)2009 (influenza A(H1N1)pdm09) and their infants', '40 women reported becoming pregnant during the follow-up phase after receiving the']","['placebo or VLP vaccine', 'placebo, (2) 15 μg dose of VLP vaccine, or (3) 45 μg dose of VLP vaccine', 'influenza vaccine']","['incidence of preeclampsia, fetal death, preterm delivery, and premature rupture of membranes', 'Antibody titers against VLP', 'adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles (morphologic abnormality)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C2936379', 'cui_str': 'Vaccines, Virus-Like Particle'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.0839513,Antibody titers against VLP were measured in the mothers and infants at delivery and at six months and one year after birth.,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Cérbulo-Vázquez', 'Affiliation': 'Facultad de Medicina, Plan de Estudios Combinados en Medicina (MD, PhD Program), Universidad Nacional Autónoma de México, Mexico City CP 04510, Mexico. cerbulo@unam.mx.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Arriaga-Pizano', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. landapi@hotmail.com.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Cruz-Cureño', 'Affiliation': 'Escuela Nacional de Ciencias Biológicas, Programa de Inmunología, Instituto Politécnico Nacional, Mexico City CP 11340, Mexico. gabrielacruz30@gmail.com.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Boscó-Gárate', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. ibosco45@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ferat-Osorio', 'Affiliation': 'Servicio de Cirugía Gastrointestinal, Unidad Médica de Alta Especialidad, Hospital de Especialidades Dr Bernardo Sepúlveda Gutiérrez, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. eduardoferat@prodigy.net.mx.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Pastelin-Palacios', 'Affiliation': 'Departamento de Biología, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City CP 04510, Mexico. rodolfop@unam.mx.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Figueroa-Damian', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Perinatología, Mexico City CP 11000, Mexico. rfd6102@yahoo.com.mx.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Castro-Eguiluz', 'Affiliation': 'Consejo Nacional de Ciencia y Tecnología (CONACYT)- Departamento de Investigación Clínica, Instituto Nacional de Cancerología, Mexico City CP 14080, Mexico. angeldenisse@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Mancilla-Ramirez', 'Affiliation': 'Escuela Superior de Medicina, Instituto Politécnico Nacional; Hospital de la Mujer, Secretaria de Sauld, Mexico City CP 11340, Mexico. javiermancilla@hotmail.com.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Isibasi', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. isibasi@prodigy.net.mx.'}, {'ForeName': 'Constantino', 'Initials': 'C', 'LastName': 'López-Macías', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. constantino@sminmunologia.mx.'}]",Viruses,['10.3390/v11090868']
770,29571974,An interactive contouring module improves engagement and interest in radiation oncology among preclinical medical students: Results of a randomized trial.,"PURPOSE


Studies have shown significant gaps in knowledge of radiation therapy among medical students and primary care providers. The goal of this study was to evaluate the effect of an interactive contouring module on knowledge and interest in radiation oncology among preclinical medical students.
METHODS AND MATERIALS


Second-year medical students at the University of California, San Diego were randomized to participate in an interactive contouring exercise or watch a traditional didactic lecture on radiation oncology. Participants completed knowledge tests and surveys at baseline, immediately following the exercise, and 3 months later. Statistical analysis included Wilcoxon signed-rank test for pre- and posttest comparisons and Wilcoxon rank sum test for comparison between groups.
RESULTS


Forty-three medical students participated in the trial (21 in the didactic group; 22 in the contouring group). Students completing the contouring module demonstrated similar overall knowledge improvement compared with the traditional didactic group (+8.6% vs +6.6%, not significant) but endorsed greater engagement on a 5-point Likert-type scale (3.10 vs 3.76, P = .02). At 3-month follow-up, there was a nonsignificant trend toward improved overall knowledge in the contouring group (43% vs 51%, P = .10), with a significance difference in a subset of questions on knowledge of the process of radiation therapy as well as side effects (51% vs 75%, P = .002). Students in the contouring group demonstrated more interest in pursuing a clinical radiation oncology rotation (2.52 vs 3.27, P = .01).
CONCLUSIONS


Use of an interactive contouring module was an effective method to teach preclinical medical students about radiation oncology, with no significant difference in knowledge gained compared with a traditional didactic lecture; however, higher engagement among students completing the contouring module led to improved retention of knowledge of radiation side effects and greater interest in radiation oncology. These data suggest a potential benefit of integrating an interactive radiation oncology module into the preclinical medical school curriculum.",2018,"Students completing the contouring module demonstrated similar overall knowledge improvement compared with the traditional didactic group (+8.6% vs +6.6%, not significant) but endorsed greater engagement on a 5-point Likert-type scale (3.10 vs 3.76, P = .02).","['medical students and primary care providers', 'Forty-three medical students participated in the trial (21 in the didactic group; 22 in the contouring group', 'preclinical medical students', 'Second-year medical students at the University of California, San Diego']","['interactive contouring exercise or watch a traditional didactic lecture on radiation oncology', 'interactive contouring module']","['5-point Likert-type scale', 'overall knowledge improvement', 'side effects', 'retention of knowledge of radiation side effects', 'overall knowledge', 'clinical radiation oncology rotation']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",,0.0261545,"Students completing the contouring module demonstrated similar overall knowledge improvement compared with the traditional didactic group (+8.6% vs +6.6%, not significant) but endorsed greater engagement on a 5-point Likert-type scale (3.10 vs 3.76, P = .02).","[{'ForeName': 'Pushpa', 'Initials': 'P', 'LastName': 'Neppala', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Sherer', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Larson', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Alex K', 'Initials': 'AK', 'LastName': 'Bryant', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Panjwani', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Murphy', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Erin F', 'Initials': 'EF', 'LastName': 'Gillespie', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: efgillespie@ucsd.edu.'}]",Practical radiation oncology,['10.1016/j.prro.2018.01.001']
771,21533629,"Effect of diet, enalapril, or losartan in post-diarrheal hemolytic uremic syndrome nephropathy.","Proteinuria is the main indicator of renal disease progression in many chronic conditions. There is currently little information available on the efficacy, safety, and individual tolerance of patients with post-diarrheal hemolytic uremic syndrome (D+ HUS) nephropathy to therapies involving diet, enalapril, or losartan. A multicenter, double-blind, randomized controlled trail was conducted to evaluate the effect of a normosodic-normoproteic diet (Phase I) and the effect of normosodic-normoproteic diet plus enalapril (0.18-0.27 mg/kg/day) or losartan (0.89-1.34 mg/kg/day) (Phase II) on children with D+ HUS, normal renal function, and persistent, mild (5.1-49.9 mg/kg/day) proteinuria. Dietary intervention reduced the mean protein intake from 3.4 to 2.2 mg/kg/day. Of 137 children, proteinuria normalized in 91 (66.4 %) within 23-45 days; the remaining 46 patients were randomized to diet plus placebo (group 1, n = 16), plus losartan (group 2, n = 16), or enalapril (group 3, n = 14). In groups 1, 2, and 3, proteinuria was reduced by 30.0, 82.0, and 66.3%, respectively, and normalized in six (37.5%), three (81.3%), and 11 (78.6%) patients, respectively (χ(2)= 8.9, p = 0.015). These results suggest that: (1) a normosodic-normoproteic diet can normalize proteinuria in the majority of children with D+ HUS with mild sequelae, (2) the addition of enalapril or losartan to such dietary restrictions of protein further reduces proteinuria, and (3) these therapeutic interventions are safe and well tolerated. Whether these short-term effects can be extended to the long-term remains to be demonstrated.",2011,"In groups 1, 2, and 3, proteinuria was reduced by 30.0, 82.0, and 66.3%, respectively, and normalized in six (37.5%), three (81.3%), and 11 (78.6%) patients, respectively (χ(2)= 8.9, p = 0.015).","['patients with post-diarrheal hemolytic uremic syndrome (D+ HUS) nephropathy', 'post-diarrheal hemolytic uremic syndrome nephropathy', '137 children, proteinuria normalized in 91 (66.4 %) within 23-45 days; the remaining 46 patients', 'children with D+ HUS, normal renal function, and persistent, mild (5.1-49.9 mg/kg/day) proteinuria']","['diet, enalapril, or losartan', 'enalapril or losartan', 'losartan', 'normosodic-normoproteic diet plus enalapril', 'plus losartan', 'enalapril', 'Dietary intervention', 'enalapril, or losartan', 'diet plus placebo', 'normosodic-normoproteic diet']","['mean protein intake', 'proteinuria', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019061', 'cui_str': ""Gasser's Syndrome""}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",137.0,0.0254029,"In groups 1, 2, and 3, proteinuria was reduced by 30.0, 82.0, and 66.3%, respectively, and normalized in six (37.5%), three (81.3%), and 11 (78.6%) patients, respectively (χ(2)= 8.9, p = 0.015).","[{'ForeName': 'Maria Gracia', 'Initials': 'MG', 'LastName': 'Caletti', 'Affiliation': 'Hospital Garrahan, Buenos Aires, Argentina. mcaletti@garrahan.gov.ar'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Missoni', 'Affiliation': ''}, {'ForeName': 'Clarisa', 'Initials': 'C', 'LastName': 'Vezzani', 'Affiliation': ''}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Grignoli', 'Affiliation': ''}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Piantanida', 'Affiliation': ''}, {'ForeName': 'Horacio A', 'Initials': 'HA', 'LastName': 'Repetto', 'Affiliation': ''}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Exeni', 'Affiliation': ''}, {'ForeName': 'Stella Maris', 'Initials': 'SM', 'LastName': 'Rasse', 'Affiliation': ''}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-011-1867-0']
772,29675483,"Fresh versus frozen embryo transfer after gonadotropin-releasing hormone agonist trigger in gonadotropin-releasing hormone antagonist cycles among high responder women: A randomized, multi-center study.","Background


The use of embryo cryopreservation excludes the possible detrimental effects of ovarian stimulation on the endometrium, and higher reproductive outcomes following this policy have been reported. Moreover, gonadotropin-releasing hormone agonist trigger in gonadotropin-releasing hormone (GnRH) antagonist cycles as a substitute for standard human chorionic gonadotropin trigger, minimizes the risk of ovarian hyperstimulation syndrome (OHSS) in fresh as well as frozen embryo transfer cycles (FET).
Objective


To compare the reproductive outcomes and risk of OHSS in fresh vs frozen embryo transfer in high responder patients, undergoing in vitro fertilization triggered with a bolus of GnRH agonist.
Materials and Methods


In this randomized, multi-centre study, 121 women undergoing FET and 119 women undergoing fresh ET were investigated as regards clinical pregnancy as the primary outcome and the chemical pregnancy, live birth, OHSS development, and perinatal data as secondary outcomes.
Results


There were no significant differences between FET and fresh groups regarding chemical (46.4% vs. 40.2%, p=0.352), clinical (35.8% vs. 38.3%, p=0.699), and ongoing (30.3% vs. 32.7%, p=0.700) pregnancy rates, also live birth (30.3% vs. 29.9%, p=0.953), perinatal outcomes, and OHSS development (35.6% vs. 42.9%, p=0.337). No woman developed severe OHSS and no one required admission to hospital.
Conclusion


Our findings suggest that GnRHa trigger followed by fresh transfer with modified luteal phase support in terms of a small human chorionic gonadotropin bolus is a good strategy to secure good live birth rates and a low risk of clinically relevant OHSS development in in vitro fertilization patients at risk of OHSS.",2018,"There were no significant differences between FET and fresh groups regarding chemical (46.4% vs. 40.2%, p=0.352), clinical (35.8% vs. 38.3%, p=0.699), and ongoing (30.3% vs. 32.7%, p=0.700) pregnancy rates, also live birth (30.3% vs. 29.9%, p=0.953), perinatal outcomes, and OHSS development (35.6% vs. 42.9%, p=0.337).","['121 women undergoing FET and 119 women undergoing fresh ET', 'high responder patients, undergoing in vitro fertilization triggered with a bolus of GnRH agonist', 'high responder women']","['FET', 'OHSS in fresh vs frozen embryo transfer']","['severe OHSS', 'chemical pregnancy, live birth, OHSS development, and perinatal data as secondary outcomes', 'pregnancy rates, also live birth', 'perinatal outcomes, and OHSS development']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",121.0,0.133343,"There were no significant differences between FET and fresh groups regarding chemical (46.4% vs. 40.2%, p=0.352), clinical (35.8% vs. 38.3%, p=0.699), and ongoing (30.3% vs. 32.7%, p=0.700) pregnancy rates, also live birth (30.3% vs. 29.9%, p=0.953), perinatal outcomes, and OHSS development (35.6% vs. 42.9%, p=0.337).","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Aflatoonian', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Mansoori-Torshizi', 'Affiliation': 'Novin Infertility Center, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farid Mojtahedi', 'Affiliation': ""Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Roointan Arash Women's Health Research and Educational Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Aflatoonian', 'Affiliation': 'Stem Cell Biology Research Center, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammaad Ali', 'Initials': 'MA', 'LastName': 'Khalili', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Amir-Arjmand', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Soleimani', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Aflatoonian', 'Affiliation': 'Madar Hospital, Yazd, Iran.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Oskouian', 'Affiliation': 'Armaghan Infertility & IVF Clinic, Mashhad, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Tabibnejad', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humaidan', 'Affiliation': 'The Fertility Clinic, Skive Regional Hospital and Faculty of Health, Aarhus University, Aarhus, Denmark.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
773,29716419,Lecture-based versus problem-based learning in ethics education among nursing students.,"BACKGROUND


Moral reasoning is a vital skill in the nursing profession. Teaching moral reasoning to students is necessary toward promoting nursing ethics.
OBJECTIVES


The aim of this study was to compare the effectiveness of problem-based learning and lecture-based methods in ethics education in improving (1) moral decision-making, (2) moral reasoning, (3) moral development, and (4) practical reasoning among nursing students.
RESEARCH DESIGN


This is a repeated measurement quasi-experimental study.
PARTICIPANTS AND RESEARCH CONTEXT


The participants were nursing students in a University of Medical Sciences in west of Iran who were randomly assigned to the lecture-based (n = 33) or the problem-based learning (n = 33) groups. The subjects were provided nursing ethics education in four 2-h sessions. The educational content was similar, but the training methods were different. The subjects completed the Nursing Dilemma Test before, immediately after, and 1 month after the training. The data were analyzed and compared using the SPSS-16 software.
ETHICAL CONSIDERATIONS


The program was explained to the students, all of whom signed an informed consent form at the baseline.
FINDINGS


The two groups were similar in personal characteristics (p > 0.05). A significant improvement was observed in the mean scores on moral development in the problem-based learning compared with the lecture-based group (p < 0.05). Although the mean scores on moral reasoning improved in both the problem-based learning and the lecture-based groups immediately after the training and 1 month later, the change was significant only in the problem-based learning group (p < 0.05). The mean scores on moral decision-making, practical considerations, and familiarity with dilemmas were relatively similar for the two groups.
CONCLUSION


The use of the problem-based learning method in ethics education enhances moral development among nursing students. However, further studies are needed to determine whether such method improves moral decision-making, moral reasoning, practical considerations, and familiarity with the ethical issues among nursing students.",2019,"Although the mean scores on moral reasoning improved in both the problem-based learning and the lecture-based groups immediately after the training and 1 month later, the change was significant only in the problem-based learning group (p < 0.05).","['participants were nursing students in a University of Medical Sciences in west of Iran who were randomly assigned to the lecture-based (n = 33) or the', 'nursing students', 'Participants and research context']","['problem-based learning and lecture-based methods in ethics education', 'Lecture-based versus problem-based learning', 'problem-based learning']","['moral reasoning', 'mean scores on moral decision-making, practical considerations, and familiarity with dilemmas', 'mean scores on moral development']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035168'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}]","[{'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0026532', 'cui_str': 'Morals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0026527', 'cui_str': 'Moral Development'}]",,0.0192198,"Although the mean scores on moral reasoning improved in both the problem-based learning and the lecture-based groups immediately after the training and 1 month later, the change was significant only in the problem-based learning group (p < 0.05).","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Khatiban', 'Affiliation': 'Associate Profssor, Mother and Child Care Research Center, Dept. of Medical Surgical Nursing, School of Nursing and Midwifery School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyede Nayereh', 'Initials': 'SN', 'LastName': 'Falahan', 'Affiliation': 'Instructor, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Amini', 'Affiliation': 'Faculty Member, Chronic Diseases (Home care) Research Center, Dept. of Community Health Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Farahanchi', 'Affiliation': 'Assistant Professor, Department of Forensic Medicine and Professional Ethics, Medical School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soltanian', 'Affiliation': 'Associate Professor, Modeling of Noncommunicable Diseases Research Center, Dept. of Biostatistics, School of Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Nursing ethics,['10.1177/0969733018767246']
774,29735186,Comparing Intensity-Modulated Proton Therapy With Intensity-Modulated Photon Therapy for Oropharyngeal Cancer: The Journey From Clinical Trial Concept to Activation.,"Intensity-modulated proton therapy minimizes the incidental irradiation of normal tissues in patients with head and neck cancer relative to intensity-modulated photon (x-ray) therapy and has been associated with lesser treatment-related toxicity and improved quality of life. A phase II/III randomized trial sponsored by the US National Cancer Institute is currently underway to compare deintensification treatment strategies with intensity-modulated proton therapy vs intensity-modulated photon (x-ray) therapy for patients with advanced-stage oropharyngeal tumors. After significant input from numerous stakeholders, the phase III portion of the randomized trial was redesigned as a noninferiority trial with progression-free survival as the primary endpoint. The process by which that redesign took place is described here.",2018,Intensity-modulated proton therapy minimizes the incidental irradiation of normal tissues in patients with head and neck cancer relative to intensity-modulated photon (x-ray) therapy and has been associated with lesser treatment-related toxicity and improved quality of life.,"['patients with advanced-stage oropharyngeal tumors', 'Oropharyngeal Cancer', 'patients with head and neck cancer']","['intensity-modulated proton therapy vs intensity-modulated photon (x-ray) therapy', 'Intensity-modulated proton therapy', 'Intensity-Modulated Proton Therapy With Intensity-Modulated Photon Therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C0086805', 'cui_str': 'Photons'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity (attribute)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}]",[],,0.0242739,Intensity-modulated proton therapy minimizes the incidental irradiation of normal tissues in patients with head and neck cancer relative to intensity-modulated photon (x-ray) therapy and has been associated with lesser treatment-related toxicity and improved quality of life.,"[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Frank', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: sjfrank@mdanderson.org.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Merrill S', 'Initials': 'MS', 'LastName': 'Kies', 'Affiliation': 'Department of Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Machtay', 'Affiliation': 'Department of Radiation Oncology, UH Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Bhadrasain', 'Initials': 'B', 'LastName': 'Vikram', 'Affiliation': 'Clinical Radiation Oncology Branch, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Garden', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'G Brandon', 'Initials': 'GB', 'LastName': 'Gunn', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Fuller', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hutcheson', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Busse', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Nancy Y', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Foote', 'Affiliation': 'Department of Radiation Oncology, The Mayo Clinic, Rochester, MN.'}]",Seminars in radiation oncology,['10.1016/j.semradonc.2017.12.002']
775,29492472,In vitro fertilization outcome in frozen versus fresh embryo transfer in women with elevated progesterone level on the day of HCG injection: An RCT.,"Background


The effect of elevated progesterone level on human chorionic gonadotropin (HCG) day in in vitro fertilization cycles is controversial. Some suppose that rise in progesterone level seems to have a negative impact on implantation and pregnancy by desynchronizing the endometrium, while others disagree.
Objective


To evaluate the superiority of the frozen cycle over fresh cycle on live birth in patients with elevated progesterone level on HCG day.
Materials and Methods


In this double-blind, randomized clinical trial, 72 women undergoing assisted reproductive technology with elevated progesterone level (≥1.8 ng/dl) on HCG day were included. The participants were grouped by fresh versus frozen embryo transfer, randomly. Finally, the clinical pregnancy and live birth rate were compared.
Results


The implantation rate was 21.51%. The clinical pregnancy rate was 47.22% in fresh embryo transfer group (17/36) and 41.66% in frozen group (15/36) (p=0. 40). The live birth rate was not significantly difference between two groups (p=0.56).
Conclusion


None of the fresh and frozen cycles are superior to the other and we recommend individualizing the decision for each patient. The frozen cycle may impose more emotional stress on patients.",2017,The clinical pregnancy rate was 47.22% in fresh embryo transfer group (17/36) and 41.66% in frozen group (15/36),"['patients with elevated progesterone level on HCG day', '72 women undergoing assisted reproductive technology with elevated progesterone level (≥1.8 ng/dl) on HCG day were included', 'women with']","['frozen versus fresh embryo transfer', 'elevated progesterone level']","['emotional stress', 'clinical pregnancy and live birth rate', 'live birth rate', 'clinical pregnancy rate', 'elevated progesterone level', 'implantation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0440732', 'cui_str': 'Fresh embryo (substance)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}]","[{'cui': 'C0086209', 'cui_str': 'Emotional Stress'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",72.0,0.215496,The clinical pregnancy rate was 47.22% in fresh embryo transfer group (17/36) and 41.66% in frozen group (15/36),"[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Aghahosseini', 'Affiliation': 'Department of Obstetrics and Gynecology and Infertility, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aleyasin', 'Affiliation': 'Department of Obstetrics and Gynecology and Infertility, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh Sadat', 'Initials': 'FS', 'LastName': 'Sarfjoo', 'Affiliation': 'Department of Obstetrics and Gynecology and Infertility, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atossa', 'Initials': 'A', 'LastName': 'Mahdavi', 'Affiliation': 'Department of Obstetrics and Gynecology and Infertility, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Yaraghi', 'Affiliation': 'Department of Obstetrics, Gynecology and Pelvic Floor Disorders, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hojattollah', 'Initials': 'H', 'LastName': 'Saeedabadi', 'Affiliation': 'Department of Embryology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
776,31630465,Ultrasound-guided erector spinae plane block for postoperative analgesia in pediatric patients undergoing splenectomy: A prospective randomized controlled trial.,"BACKGROUND


Many analgesic modalities have been investigated in pediatrics. We studied the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block in pediatric patients undergoing open midline splenectomy.
METHODS


Sixty patients aged 3-10 years were randomly assigned into two groups: Control group received general anesthesia with bilateral sham erector spinae plane block using 0.3 mL/kg normal saline on each side. Erector spinae plane block group received bilateral ultrasound-guided erector spinae plane block using 0.3 mL/kg bupivacaine 0.25% (on each side) with a maximum dose of 2 mg/kg. Children's Hospital Eastern Ontario Pain Scale (CHEOPS), total consumption of intraoperative fentanyl (1 µg/kg IV in case of inadequate analgesia), time to first rescue analgesic administration, and postoperative paracetamol consumption were recorded over the first 24 hours postoperatively.
RESULTS


The median (IQR) postoperative CHEOPS score at 1 hour was lower in erector spinae plane block group (5.0 (4.75 -5.25)) than the control group (7.0 (6.0-10.0)) (P < .001, 95% CI: 1.0; 5.0). The CHEOPS scores for the first eight postoperative hours were lower in the erector spinae plane block group (5.0 (5.0-6.0)) than the control group (6.0 (6.0 -10.0)) (P ˂ .001, 95% CI: 1.0; 2.0). Intraoperative fentanyl administration was higher in the control group 40.0 (21.5-50.0) μg compared to erector spinae plane block group 0.0 (0.0-0.0) μg (P ˂ .001, 95% CI: 23.0; 48.0). The total postoperative paracetamol consumption was higher in the control group (37.5 ± 17.1 mg/kg) compared to erector spinae plane block group (8.5 ± 10.9 mg/kg) (P ˂ .001, 95% CI: 21.57; 36.43). The time to the first postoperative rescue analgesic requirement was longer in the erector spinae plane block group.
CONCLUSION


Ultrasound-guided erector spinae plane block reduced CHEOPS score for the first eight hours postoperatively with the reduction of intraoperative fentanyl and postoperative paracetamol consumptions.",2019,"Intraoperative fentanyl administration was higher in the control group 40.0 (21.5-50.0) μg compared to erector spinae plane block group 0.0 (0.0-0.0) μg (P ˂ 0.001, 95% CI: 23.0; 48.0).","['60 patients aged 3- 10 years', 'pediatric patients undergoing open midline splenectomy', 'pediatric patients undergoing splenectomy']","['bilateral ultrasound-guided erector spinae plane block using 0.3 ml/kg bupivacaine', 'bilateral ultrasound-guided erector spinae plane block', 'Control group received general anesthesia with bilateral sham erector spinae plane block using 0.3 ml/kg normal saline', 'Ultrasound-guided erector spinae plane block']","['analgesic efficacy', 'Intraoperative fentanyl administration', 'CHEOPS scores', 'CHEOPS score', 'median (IQR) postoperative CHEOPS score', 'time to first rescue analgesic administration and postoperative paracetamol consumption', 'time to the first postoperative rescue analgesic requirement', 'total postoperative paracetamol consumption', ""Children's Hospital Eastern Ontario Pain Scale (CHEOPS), total consumption of intraoperative fentanyl""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic (procedure)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",60.0,0.199774,"Intraoperative fentanyl administration was higher in the control group 40.0 (21.5-50.0) μg compared to erector spinae plane block group 0.0 (0.0-0.0) μg (P ˂ 0.001, 95% CI: 23.0; 48.0).","[{'ForeName': 'Shaimaa F', 'Initials': 'SF', 'LastName': 'Mostafa', 'Affiliation': 'Department of anesthesia and surgical intensive care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdelghany', 'Affiliation': 'Department of anesthesia and surgical intensive care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Taysser M', 'Initials': 'TM', 'LastName': 'Abdelraheem', 'Affiliation': 'Department of anesthesia and surgical intensive care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Abu Elyazed', 'Affiliation': 'Department of anesthesia and surgical intensive care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Paediatric anaesthesia,['10.1111/pan.13758']
777,29387829,The effect of vitamin E and aspirin on the uterine artery blood flow in women with recurrent abortion: A single-blind randomized controlled trial.,"Background


Recurrent spontaneous abortion has high incidence rate. The etiology is unknown in 30-40%. However high uterine artery resistance is accounted as one of the recurrent abortion reasons.
Objective


The objective of the current study was to determine the impacts of vitamin E and aspirin on the uterine artery blood flow in women having recurrent abortions due to impaired uterine blood flow.
Materials and Methods


This randomized clinical trial was conducted on 99 women having uterine pulsatility index (PI) more than 2.5 and the history of more than two times abortions. The candidates were categorized into three groups; receiving aspirin, only vitamin E, and aspirin+vitamin E. After 2 months, uterine PIs were compared with each other.
Results


All drug regimens caused an enhancement in uterine perfusion with a significant decline in uterine artery PI value. The women receiving vitamin E in accompanied with aspirin had the least mean PI of the uterine artery (p<0.001). The total average PI score of the right and left uterine arteries in groups receiving vitamin E in accompanied with aspirin was lower than the two counterparts significantly (p<0.001).
Conclusion


Vitamin E, aspirin and especially their combination are effective in improving uterine artery blood flow in women with recurrent abortion due to impaired uterine blood flow. More well-designed studies are needed to find out whether the enhancement of uterine perfusion may lead to a better pregnancy outcome.",2017,"The total average PI score of the right and left uterine arteries in groups receiving vitamin E in accompanied with aspirin was lower than the two counterparts significantly (p<0.001).
","['99 women having uterine pulsatility index (PI) more than 2.5 and the history of more than two times abortions', 'women with recurrent abortion', 'women having recurrent abortions due to impaired uterine blood flow']","['aspirin', 'Vitamin E, aspirin', 'vitamin E and aspirin', 'aspirin, only vitamin E, and aspirin+vitamin E', 'vitamin E']","['enhancement in uterine perfusion', 'uterine artery blood flow', 'uterine artery PI value', 'uterine PIs', 'total average PI score of the right and left uterine arteries']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0000809', 'cui_str': 'Recurrent Early Pregnancy Loss'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",99.0,0.188919,"The total average PI score of the right and left uterine arteries in groups receiving vitamin E in accompanied with aspirin was lower than the two counterparts significantly (p<0.001).
","[{'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Mesdaghinia', 'Affiliation': 'Department of Obstetrics and Gynecology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Mohammad-Ebrahimi', 'Affiliation': 'Department of Obstetrics and Gynecology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': 'Department of Obstetrics and Gynecology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
778,31568997,Using community health workers to deliver a scalable integrated parenting program in rural China: A cluster-randomized controlled trial.,"Inadequate care during early childhood can lead to long-term deficits in skill development. Parenting programs are promising tools for improving parenting practices and opportunities for healthy development. We implemented a non-masked cluster-randomized controlled trial in rural China in order to assess the effectiveness of an integrated home-visitation program that includes both psychosocial stimulation and health promotion at fostering development and health outcomes of infants and toddlers in rural China. All 6-18 month-old children of two rural townships and their main caregiver were enrolled. Villages were stratified by township and randomly assigned to intervention or control. Specifically, in September 2015 we assigned 43 clusters to treatment (21 villages, 222 caregiver-child dyads) or control (22 villages, 227 caregiver-child dyads). In the intervention group, community health workers delivered education and training on how to provide young children with psychosocial stimulation and health care (henceforth psychosocial stimulation and health promotion) during bi-weekly home visits over the period of one year. The control group received no home visits. Primary outcomes include measures of child development (i.e. the Bayley Scales of Infant and Toddler Development, third edition-or Bayley-III) and health (i.e. measures of morbidity, nutrition, and growth). Secondary outcomes are measures of parenting practices. Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD) [95% CI 0·04 SD-0·44 SD] in cognitive development and to a reduction of 8·1 [95% CI 3·8-12·4] percentage points in the risk of diarrheal illness. In addition, we find positive effects on parenting practices mirroring these results. We conclude that an integrated psychosocial stimulation and health promotion program improves development and health outcomes of infants and toddlers (6-30 month-old children) in rural China. Because of low incremental costs of adding program components (that is, adding health promotion to psychosocial stimulation programs), integrated programs may be cost-effective.",2019,Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD),"['infants and toddlers (6-30 month-old children) in rural China', 'rural China', 'All 6-18 month-old children of two rural townships and their main caregiver were enrolled', 'infants and toddlers in rural China', 'September 2015 we assigned 43 clusters to treatment (21 villages, 222 caregiver-child dyads) or control (22 villages, 227 caregiver-child dyads']","['scalable integrated parenting program', 'integrated psychosocial stimulation and health promotion program', 'psychosocial stimulation and health care (henceforth psychosocial stimulation and health promotion', 'community health workers delivered education and training', 'integrated home-visitation program']","['measures of parenting practices', 'Intention-to-treat (ITT) effects', 'development and health outcomes', '0·24 standard deviations (SD', 'measures of child development (i.e. the Bayley Scales of Infant and Toddler Development, third edition-or Bayley-III) and health (i.e. measures of morbidity, nutrition, and growth']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",227.0,0.0659255,Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD),"[{'ForeName': 'Renfu', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'China Centre for Agricultural Policy (CCAP), School of Advanced Agricultural Sciences (SAAS), Peking University (PKU), Beijing, China.'}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Emmers', 'Affiliation': 'LICOS, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Warrinnier', 'Affiliation': 'LICOS, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rozelle', 'Affiliation': 'Freeman Spogli Institute for International Studies, Stanford University, Stanford, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Sylvia', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health and the Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, USA. Electronic address: sean.sylvia@unc.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.112545']
779,29404536,Low-dose hCG as trigger day and 35 hr later have different ovarian hyperstimulation syndrome occurrence in females undergoing In vitro fertilization: An RCT.,"Background


Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication, which can cause high morbidity and mortality. Use of gonadotropin releasing hormone (GnRH) agonist instead of human chorionic gonadotropin (hCG) in GnRH antagonist cycles causes luteinizing hormone surge by GnRH stimulation which reduces the risk of OHSS by reducing the total amount of gonadotropin; however, there is no possibility of transferring fresh embryos.
Objective


The current study aimed to evaluate the effect of hCG along with GnRH agonist administration in the occurrence of OHSS and pregnancy rate in females undergoing in vitro fertilization.
Materials and Methods


The current randomized clinical trial was conducted on 80 cases in 2 groups. Gonal-F was used to stimulate the oocyte from the second day of menstruation. When follicle size was 12-14 mm, GnRH antagonist was added to the protocol till the detection of more than two follicles greater than 18 mm. Then, GnRH agonist was added to the protocol as a trigger. In group A, 35 hr after the administration of GnRH agonist, the low-dose human hCG, 1500 IU, was used. In group B, low-dose hCG, 1500 IU, was used at the same time by GnRH agonist administration. The rate of pregnancy, OHSS, and its severity were compared between 2 groups within 2 wk.
Results


There was no significant difference regarding chemical and clinical pregnancies between the 2 groups. Severe OHSS was significantly higher in group B (p= 0.03).
Conclusion


Administration of hCG 35 hr after GnRH agonist administration results in lower rate of severe OHSS.",2017,"Severe OHSS was significantly higher in group B (p= 0.03).
","['\n\n\nOvarian hyperstimulation syndrome (OHSS', 'females undergoing In vitro fertilization', 'females undergoing in vitro fertilization', '80 cases in 2 groups']","['Low-dose hCG', 'gonadotropin releasing hormone (GnRH) agonist instead of human chorionic gonadotropin (hCG', 'GnRH agonist administration', 'hCG']","['Severe OHSS', 'rate of severe OHSS', 'chemical and clinical pregnancies', 'rate of pregnancy, OHSS, and its severity', 'OHSS and pregnancy rate', 'ovarian hyperstimulation syndrome occurrence']","[{'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.187309,"Severe OHSS was significantly higher in group B (p= 0.03).
","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Aghahosseini', 'Affiliation': 'Department of Infertility, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aleyasin', 'Affiliation': 'Department of Infertility, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Chegini', 'Affiliation': 'Department of Obstetrics and Gynecology, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Chegini', 'Affiliation': 'Qazvin University of Medical Sciences, Qazvin, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
780,31628923,The role of recombinant Human erythropoietin in neonatal anemia.,"AIM


To estimate the blood level of Erythropoietin(EPO) in neonates with anemia of prematurity (APO) and in late hypo-regenerative anemia and to clarify role of EPO in correction of anemia and reducing the number of blood transfusions.
METHODS


This study was carried out on 60 neonates divided into; group I (30 preterm neonates) with AOP received EPO (250 IU/kg/dose subcutaneously 3 times weekly for 4 weeks), compared to group II (30 neonates) with AOP treated only with blood transfusion. CBC parameters and transfusion requirements were followed during therapy. Serum level of EPO was measured by ELISA technique.
RESULTS


By the end of the 4th week of therapy, there was significant increase in group I post r-Hu EPO compared to group II regarding reticulocyte counts (P < 0.001) leading to rise of the Hb (P < 0.001), Hct levels (P < 0.001) with subsequent reduction in the overall number of blood transfusions (P < 0.001).
CONCLUSION


EPO therapy in conjunction with iron, vitamin E and folic acid, stimulated erythropoiesis and significantly reduced the need for blood transfusion in AOP.",2020,"There were significant higher levels of reticulocytes (P < 0.001), Hb (P < 0.001) and Hct (P < 0.001) values in group III post r-Hu EPO compared to group IV, while number of blood transfusions did not differ significantly among them (P = 1.0).
","['neonates with anemia of prematurity (APO) and in late hypo-regenerative anemia', '80 neonates divided into; group I (30 preterm neonates) with', 'neonatal anemia']","['recombinant Human erythropoietin', 'AOP treated only with blood transfusion; Group III (10 neonates, GA\u202f≥\u202f37\u202fweeks) with late hypo-regenerative post haemolytic anemia, treated with the same dose of r-Hu EPO and compared to group IV (10 neonates) treated only with blood transfusion', 'Erythropoietin (EPO', 'AOP received EPO', 'EPO therapy']","['levels of reticulocytes', 'Serum level of EPO', 'Hematological measurements and transfusion requirements', 'number of blood transfusions', 'Hct levels', 'overall number of blood transfusions']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0158996', 'cui_str': 'Anemia of prematurity (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1263989', 'cui_str': 'Responsive anemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0002891', 'cui_str': 'Anemia Neonatorum'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0312853', 'cui_str': 'Hemolytic (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035286', 'cui_str': 'Reticulocytes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0167898,"There were significant higher levels of reticulocytes (P < 0.001), Hb (P < 0.001) and Hct (P < 0.001) values in group III post r-Hu EPO compared to group IV, while number of blood transfusions did not differ significantly among them (P = 1.0).
","[{'ForeName': 'Dalia M', 'Initials': 'DM', 'LastName': 'El-Lahony', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Nagwan Y', 'Initials': 'NY', 'LastName': 'Saleh', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Mona S', 'Initials': 'MS', 'LastName': 'Habib', 'Affiliation': 'Medical Biochemistry Department, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Shehata', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'El-Hawy', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Menoufia University, Menoufia, Egypt. Electronic address: mahmoud.elhawi@med.menofia.edu.eg.'}]",Hematology/oncology and stem cell therapy,['10.1016/j.hemonc.2019.08.004']
781,29404530,The effect of a positive reappraisal coping intervention and problem-solving skills training on coping strategies during waiting period of IUI treatment: An RCT.,"Background


Waiting period of fertility treatment is stressful, therefore it is necessary to use effective coping strategies to cope with waiting period of intrauterine insemination (IUI) treatment.
Objective


The aim of this study was comparing the effect of the positive reappraisal coping intervention (PRCI) with the problem-solving skills training (PSS) on the coping strategies of IUI waiting period, in infertile women referred to Milad Infertility Center in Mashhad.
Materials and Methods


In this randomized clinical trial, 108 women were evaluated into three groups. The control group received the routine care, but in PRCI group, two training sessions were held and they were asked to review the coping thoughts cards and fill out the daily monitoring forms during the waiting period, and in PSS group problem-solving skill were taught during 3 sessions. The coping strategies were compared between three groups on the 10 th  day of IUI waiting period.
Results


Results showed that the mean score for problem-focused were significantly different between the control (28.54±9.70), PSS (33.71±9.31), and PRCI (30.74±10.96) (p=0.025) groups. There were significant differences between the PSS group and others groups, and mean emotion-focused were significantly different between the control (32.09±11.65), PSS (29.20±9.88), and PRCI (28.74±7.96) (p=0.036) groups. There were significant differences between the PRCI and the control group (p=0.047).
Conclusion


PSS was more effective to increase problem-focused coping strategies than PRCI, therefore it is recommended that this intervention should be used in infertility treatment centers.",2017,"There were significant differences between the PSS group and others groups, and mean emotion-focused were significantly different between the control (32.09±11.65), PSS (29.20±9.88), and PRCI (28.74±7.96) (p=0.036) groups.","['108 women were evaluated into three groups', 'infertile women referred to Milad Infertility Center in Mashhad']","['PSS', 'positive reappraisal coping intervention and problem-solving skills training', 'positive reappraisal coping intervention (PRCI) with the problem-solving skills training (PSS', 'routine care, but in PRCI group, two training sessions were held and they were asked to review the coping thoughts cards and fill out the daily monitoring forms during the waiting period, and in PSS group problem-solving skill']","['mean score for problem', 'mean emotion']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",108.0,0.0230123,"There were significant differences between the PSS group and others groups, and mean emotion-focused were significantly different between the control (32.09±11.65), PSS (29.20±9.88), and PRCI (28.74±7.96) (p=0.036) groups.","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Ghasemi', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Kordi', 'Affiliation': 'Research Center for Evidence-Based Health Care, Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Asgharipour', 'Affiliation': 'Research Center for Psychiatry and Behavioral Sciences, Department of Clinical Psychology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Esmaeili', 'Affiliation': 'Research Center for Management and Social Factors Influencing Health, Department of Biostatistics, Faculty of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Amirian', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
782,29404531,Triage by cervical length sonographic measurements for targeted therapy in threatened preterm labor: A double blind randomized clinical trial.,"Background


Preterm labor and birth are associated with several neonatal complications including respiratory distress syndrome and intraventricular hemorrhage. Differentiating true and false labor pain is a dilemma to obstetricians.
Objective


To elucidate the role of cervical length measurement in prediction of birth in pregnant women with threatened preterm labor.
Materials and Methods


In this double blind randomized clinical trial, 120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length. Patients were registered in the hospital and a unit number was given. Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator. All participants were managed accordingly (n=65) or to receive tocolysis as planned (n=55). Tocolysis was prescribed when cervical length was <15 mm while those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of the presentation was the primary outcome.
Results


This RCT showed in case group, 78.9% of patient with cervical length <15 mm were delivered within 7 days and only 21.1% of them maintained their pregnancy. Of those with cervical length ≥15 mm, only 15.2% were delivered within the study period and the rest (84.8%) maintained their pregnancy (p<0.001).
Conclusion


""Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment. Women with cervical length ≥15mm should not receive tocolysis, however, withholding corticosteroid therapy in these patients needs further evidence.",2017,"Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment.","['threatened preterm labor', 'All participants were managed accordingly (n=65) or to receive tocolysis as planned (n=55', '120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length', 'pregnant women with threatened preterm labor']","['corticosteroid therapy', 'Tocolysis', 'computerized random digit generator', 'cervical length measurement']","['preterm labor symptoms, cervical length measurement']","[{'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0040348', 'cui_str': 'Tocolytic Treatment'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0567149', 'cui_str': 'Painful uterine contractions (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040348', 'cui_str': 'Tocolytic Treatment'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C1956055', 'cui_str': 'Cervical Length Measurement'}]","[{'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1956055', 'cui_str': 'Cervical Length Measurement'}]",120.0,0.641876,"Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment.","[{'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Perinatology Ward, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Rahimirad', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Perinatology Ward, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyedeh Marjan', 'Initials': 'SM', 'LastName': 'Hosseini', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Perinatology Ward, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Perinatology Ward, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Raeisi Shahraki', 'Affiliation': 'Department of Biostatistics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
783,25434624,Does patient education and recommendation result in increased uptake of colorectal cancer screening using the fecal occult blood test?,,2014,,[],[],[],[],[],[],,0.0936424,,"[{'ForeName': 'Angelia H L', 'Initials': 'AH', 'LastName': 'Chua', 'Affiliation': 'Yishun Polyclinic, National Healthcare Group Polyclinics, Singapore.'}, {'ForeName': 'Gerald C H', 'Initials': 'GC', 'LastName': 'Koh', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
784,29177244,Final follicular maturation by administration of GnRH agonist plus HCG versus HCG in normal responders in ART cycles: An RCT.,"Background


Gonadotropin-releasing hormone agonists (GnRH-a) was increasingly used for triggering oocyte maturationfor the prevention of ovarian hyperstimulation syndrome. Studies suggest that GnRH-a might be used as a better trigger agent since it causes both Luteinizing hormone and follicle stimulating hormone release from a physiologic natural cycle.
Objective


The aim of this study was to evaluate the effect of dual-triggering in assisted reproductive technology outcomes.
Materials and Methods


192 normal responder women aged ≤42 years and 18< Body Mass Index <30 kg/m 2  enrolled in this single-blind randomized controlled trial. All participants received antagonist protocol. For final triggering, women randomly were divided into two groups. Group, I was triggered by 6500 IU human chorionic gonadotropin (hCG) alone, and group II by 6500 IU hCG plus 0.2 mg of triptorelin. The implantation, chemical, clinical and ongoing pregnancy, and abortion rates were measured.
Results


The mean of retrieved oocytes and obtained embryos were statistically higher in the dual-trigger group (group I), but the implantation and pregnancy rates were similar in two groups.
Conclusion


The results of our study did not confirm the favorable effect of dual-triggered oocyte maturation with a GnRH-a and a standard dosage of hCG as an effective strategy to optimize pregnancy outcome for normal responders in GnRH-antagonist cycles. We think that this new concept requires more studies before becoming a universal controlled ovarian hyperstimulation protocol in in vitro fertilization practice.",2017,"The mean of retrieved oocytes and obtained embryos were statistically higher in the dual-trigger group (group I), but the implantation and pregnancy rates were similar in two groups.
",['192 normal responder women aged ≤42 years and 18< Body Mass Index'],"['hCG', 'hCG plus 0.2 mg of triptorelin', 'chorionic gonadotropin (hCG) alone', 'GnRH agonist plus HCG versus HCG', '\n\n\nGonadotropin-releasing hormone agonists (GnRH-a']","['implantation and pregnancy rates', 'mean of retrieved oocytes and obtained embryos', 'implantation, chemical, clinical and ongoing pregnancy, and abortion rates']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0018062', 'cui_str': 'Chorionic Gonadotropin'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}]",,0.226922,"The mean of retrieved oocytes and obtained embryos were statistically higher in the dual-trigger group (group I), but the implantation and pregnancy rates were similar in two groups.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eftekhar', 'Affiliation': 'Reasearch and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Maryam Farid', 'Initials': 'MF', 'LastName': 'Mojtahedi', 'Affiliation': ""Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Roointan Arash Women's Health Research and Educational Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Miraj', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Omid', 'Affiliation': 'Reasearch and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
785,29177245,Controlled ovarian stimulation with r-FSH plus r-LH vs. HMG plus r-FSH in patients candidate for IVF/ICSI cycles: An RCT.,"Background


Different combination of gonadotropin preparation has been introduced with no definite superiority of one over others in in vitro fertilization (IVF), but individualized regimens for each patient are needed.
Objective


The aim of the present study was to investigate the effect of controlled ovarian stimulation with recombinant- follicle stimulating hormone (r-FSH) plus recombinant-luteinizing hormone (rLH) versus human menopausal gonadotropin (HMG) plus r-FSH on fertility outcomes in IVF patients.
Materials and Methods


This is a randomized clinical trial study that was performed from October 2014-April 2016 on 140 infertile patients with a set of inclusion criteria that referred to infertility clinics in Vali- asr and Gandhi Hospital in Tehran. The women were randomly divided into two treatment groups. The first group (n=70) received rFSH from the second day of cycle and was added HMG in 6 th  day and the 2 nd  group (n=70), received rFSH from the second day of cycle and was added recombinant-LH in 6 th  day. Then ovum Pick-Up and embryo transfer were performed. In this study, we assessed the outcomes such as; chemical and clinical pregnancy rate, live birth and abortion rate.
Results


Number of follicles in ovaries, total number of oocytes or M 2  oocytes and quality of fetuses has no significant differences between two groups (p>0.05). Total number of fetuses were significantly higher in patients who received rFSH + HMG (p=0.02). Fertility outcomes consisted of: live birth rate, chemical pregnancy and clinical pregnancy rate were higher in rFSH + HMG group in comparison to rFSH +r-LH group (p<0.05).
Conclusion


It seems that in IVF patients, HMG + rFSH used for controlled ovarian hyperstimulation have better effects on fertility outcomes, but in order to verify the results, it is recommended to implement studies on more patients.",2017,"Fertility outcomes consisted of: live birth rate, chemical pregnancy and clinical pregnancy rate were higher in rFSH + HMG group in comparison to rFSH +r-LH group (p<0.05).
","['patients candidate for IVF/ICSI cycles', 'IVF patients', 'was performed from October 2014-April 2016 on 140 infertile patients with a set of inclusion criteria that referred to infertility clinics in Vali- asr and Gandhi Hospital in Tehran']","['recombinant- follicle stimulating hormone (r-FSH) plus recombinant-luteinizing hormone (rLH) versus human menopausal gonadotropin (HMG) plus r-FSH', 'rFSH + HMG', 'r-FSH plus r-LH vs. HMG plus r-FSH', 'HMG + rFSH', 'gonadotropin preparation', 'rFSH', 'rFSH +r-LH']","['fertility outcomes', 'chemical and clinical pregnancy rate, live birth and abortion rate', 'Total number of fetuses', 'live birth rate, chemical pregnancy and clinical pregnancy rate', 'Number of follicles in ovaries, total number of oocytes or M 2  oocytes and quality of fetuses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715200', 'cui_str': 'Infertility clinic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0422809', 'cui_str': 'Number of fetuses (observable entity)'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}]",140.0,0.13333,"Fertility outcomes consisted of: live birth rate, chemical pregnancy and clinical pregnancy rate were higher in rFSH + HMG group in comparison to rFSH +r-LH group (p<0.05).
","[{'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Shahrokh Tehraninejad', 'Affiliation': 'Vali-e-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Farshbaf Taghinejad', 'Affiliation': 'Vali-e-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Batool', 'Initials': 'B', 'LastName': 'Hossein Rashidi', 'Affiliation': 'Vali-e-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fedyeh', 'Initials': 'F', 'LastName': 'Haghollahi', 'Affiliation': 'Vali-e-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
786,29177246,The effect of 24 hours delay in oocyte maturation triggering in IVF/ICSI cycles with antagonist protocol and not-elevated progesterone: A randomized control trial.,"Background


The best time of final oocyte maturation triggering in assisted reproduction technology protocols is unknown. This time always estimated by combined follicular size and blood progesterone level.
Objective


The aim of this study was evaluation of the effect of delaying oocyte maturation triggering by 24 hr on the number of mature oocytes (MII) and other in vitro fertilization cycle characteristics in antagonist protocols with not-elevated progesterone (p ≤1 ng/ml).
Materials and Methods


All patients' candidate for assisted reproduction technology underwent controlled ovarian hyperstimulation by antagonist protocol. When at least 3 follicles with ≥18 mm diameters were seen by vaginal ultrasonography; blood progesterone level was measured. The patients who had progesterone level ≤1 ng/dl entered the study. The participants' randomizations were done and patients were divided into two groups. In the first group, final oocyte maturation was done by human chorionic gonadotropin at the same day, but in the second group, this was performed 24 hr later. Oocytes retrieval was done 36 hr after human chorionic gonadotropin trigger by transvaginal ultrasound guide.
Results


Number of retrieved oocytes, mature oocytes (MII), fertilized oocytes (2PN), embryos formation, number of transferred embryos and embryos quality has not significant differences between two groups. Also, fertilization and implantation rate, chemical and clinical pregnancy did not differ between groups.
Conclusion


Delaying of triggering oocyte maturation by 24 hr in antagonist protocol with not-elevated progesterone (progesterone ≤1 ng/ml) have not beneficial nor harmful effect on the number of mature oocytes (MII) and other in vitro fertilization cycle characteristics.",2017,"Also, fertilization and implantation rate, chemical and clinical pregnancy did not differ between groups.
","['patients who had progesterone level ≤1 ng/dl entered the study', 'IVF/ICSI cycles with antagonist protocol and not-elevated progesterone']",[],"['vaginal ultrasonography; blood progesterone level', 'number of mature oocytes (MII) and other in vitro fertilization cycle characteristics', 'Results\n\n\nNumber of retrieved oocytes, mature oocytes (MII), fertilized oocytes (2PN), embryos formation, number of transferred embryos and embryos quality', 'fertilization and implantation rate, chemical and clinical pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],"[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0853949', 'cui_str': 'Blood progesterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",,0.154531,"Also, fertilization and implantation rate, chemical and clinical pregnancy did not differ between groups.
","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Naghshineh', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Nosrat', 'Initials': 'N', 'LastName': 'Neghab', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
787,31499050,Aerobic exercise with blood flow restriction affects mood state in a similar fashion to high intensity interval exercise.,"We investigated the acute effects of aerobic exercise with blood flow restriction (BFR) on mood state in American football athletes. Twenty-two male American football athletes were randomly assigned to three experimental conditions: 1) aerobic exercise (AE: 40% VO 2max ), 2) aerobic exercise with BRF (AE + BFR: 40% VO 2 max ), and 3) high-intensity interval exercise (HIIE: 80% and 40% VO 2max  during exercise and the active intervals, respectively). Mood state and total mood disturbance (TMD) were assessed before, immediately post, and 1 h post-exerciser. Ratings of perceived exertion (RPE) were measured 30 min post-exercise. AE + BFR and HIIE significantly (p < 0.05) increased fatigue and tension compared to baseline immediately post-exercise, whereas vigor significantly (p < 0.05) decreased at the same time point for both conditions. TMD increased significantly (p < 0.05) for AE + BFR and HIIE immediately post-exercise and it remained elevated up to 1 h post-exercise for AE + BFR. AE did not significantly (p > 0.05) affect mood state or TMD and it was significantly (p < 0.05) lower than AE + BFR and HIIE. AE + BFR and HIIE also elicited significantly (p < 0.05) greater RPE levels than AE 30 min post-exercise. Therefore, AE + BFR induces acute impairments in mood state and RPE levels in a similar fashion to HIIE.",2019,TMD increased significantly (p < 0.05) for AE + BFR and HIIE immediately post-exercise,"['American football athletes', 'Twenty-two male American football athletes']","['aerobic exercise (AE: 40% VO 2max ), 2) aerobic exercise with BRF (AE\u202f+\u202fBFR: 40% VO 2 max ), and 3) high-intensity interval exercise (HIIE: 80% and 40% VO 2max  during exercise', 'Aerobic exercise with blood flow restriction', 'AE\u202f+\u202fBFR and HIIE', 'aerobic exercise with blood flow restriction (BFR']","['TMD', 'mood state or TMD', 'fatigue and tension', 'RPE levels', 'Ratings of perceived exertion (RPE', 'Mood state and total mood disturbance (TMD']","[{'cui': 'C0016517', 'cui_str': 'Football'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",22.0,0.0980496,TMD increased significantly (p < 0.05) for AE + BFR and HIIE immediately post-exercise,"[{'ForeName': 'Julio Cesar Gomes', 'Initials': 'JCG', 'LastName': 'da Silva', 'Affiliation': ""Department of Physical Education, Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, Paraíba, Brazil; Coordination of Physical Education/Professional Master's in Family Health, Nursing and Medical Schools, (FAMENE/FACENE), João Pessoa, Nova Esperança, Paraíba, Brazil; Coordination of Physical Education, Center for Higher Education and Development (CESED/UNIFACISA/FCM/ESAC), Campina Grande, Paraíba, Brazil. Electronic address: juliociesar123@gmail.com.""}, {'ForeName': 'Kalinne Fernandes', 'Initials': 'KF', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Education, Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Jarbas Ralison', 'Initials': 'JR', 'LastName': 'Domingos-Gomes', 'Affiliation': 'Department of Physical Education, Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Gilmário Ricarte', 'Initials': 'GR', 'LastName': 'Batista', 'Affiliation': 'Department of Physical Education, Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Eduardo Domingos', 'Initials': 'ED', 'LastName': 'da Silva Freitas', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, United States.'}, {'ForeName': 'Vitor Bruno Cavalcanti', 'Initials': 'VBC', 'LastName': 'Torres', 'Affiliation': 'Department of Physical Education, Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, Paraíba, Brazil; Coordination of Physical Education, Center for Higher Education and Development (CESED/UNIFACISA/FCM/ESAC), Campina Grande, Paraíba, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'do Socorro Cirilo-Sousa', 'Affiliation': 'Department of Physical Education, Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, Paraíba, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112677']
788,31505191,Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial.,"OBJECTIVE


To investigate the effectiveness of lavender oil (Lavandula angustifolia Mill) inhalation on anxiety, mood, and vital signs (blood pressure, respiratory rate, heart rate, and saturation) of patients undergoing oral surgery. Vital signs were considered as primary outcome measures. Paired anxiety tests were used as secondary outcome measures.
METHODS


Patients who had dental anxiety according to the Dental Anxiety Questionnaire (DAQ) were enrolled in the study. One hundred twenty-six patients who were undergoing wisdom tooth removal under local anaesthesia were randomly assigned to the lavender oil and control groups. Paired anxiety tests (Modified Dental Anxiety Scale and State-Trait Anxiety Inventory-State Scale were performed. Vital signs were noted pre-, intra-, and post-operatively. Visual analogue scale (VAS) results were assessed. The patients' degree of satisfaction was noted.
RESULTS


Pre-operative anxiety levels were similar in both groups. Significant changes in blood pressure were observed in the lavender oil group post-operatively (p < .05). Most (79.4%) of the patients in the lavender oil group enjoyed the scent, 89.68% were satisfied with their experience, and 97.62% of the patients stated that they would prefer the same protocol when needed.
CONCLUSION


Inhalation of lavender oil, which is one of the most powerful anxiolytic essential oils, reduces peri-operative anxiety and can be prospectively considered in future studies for its potential sedative characteristics in patients undergoing surgical procedures under local anaesthesia.
TRIAL REGISTRATION NUMBER


NCT03722771 (Influence of Lavender Oil on Vital Signs in Oral Surgery Patients) https://clinicaltrials.gov/ct2/show/NCT03722771.",2019,Significant changes in blood pressure were observed in the lavender oil group post-operatively (p < .05).,"['Oral Surgery Patients', 'patients undergoing oral surgery', 'Patients who had dental anxiety according to the Dental Anxiety Questionnaire (DAQ) were enrolled in the study', 'patients undergoing surgical procedures under local anaesthesia', 'One hundred twenty-six patients who were undergoing wisdom tooth removal under local anaesthesia']","['lavender oil (Lavandula angustifolia Mill) inhalation', 'Lavender Oil', 'lavender oil inhalation', 'lavender oil']","['Paired anxiety tests (Modified Dental Anxiety Scale and State-Trait Anxiety Inventory-State Scale', 'anxiety, mood, and vital signs (blood pressure, respiratory rate, heart rate, and saturation', 'blood pressure', 'vital signs and anxiety', 'Pre-operative anxiety levels', 'Paired anxiety tests', 'Visual analogue scale (VAS']","[{'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0204147', 'cui_str': 'Extraction of wisdom tooth (procedure)'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C1623196', 'cui_str': 'Lavandula angustifolia'}, {'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0222045'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518766'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",126.0,0.0558712,Significant changes in blood pressure were observed in the lavender oil group post-operatively (p < .05).,"[{'ForeName': 'Nazife Begüm', 'Initials': 'NB', 'LastName': 'Karan', 'Affiliation': 'Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Rize, Turkey. Electronic address: nazifebegum.karan@erdogan.edu.tr.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112676']
789,29244528,"Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE.","Purpose Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET) improved clinical benefit in HER2-positive, hormone receptor (HR)-positive metastatic breast cancer (MBC) versus ET alone. Dual HER2 blockade enhances clinical benefit versus single HER2 blockade. The ALTERNATIVE study evaluated the efficacy and safety of dual HER2 blockade plus aromatase inhibitor (AI) in postmenopausal women with HER2-positive/HR-positive MBC who received prior ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy. Methods Patients were randomly assigned (1:1:1) to receive lapatinib (LAP) + TRAS + AI, TRAS + AI, or LAP + AI. Patients for whom chemotherapy was intended were excluded. The primary end point was progression-free survival (PFS; investigator assessed) with LAP + TRAS + AI versus TRAS + AI. Secondary end points were PFS (comparison of other arms), overall survival, overall response rate, clinical benefit rate, and safety. Results Three hundred fifty-five patients were included in this analysis: LAP + TRAS + AI (n = 120), TRAS + AI (n = 117), and LAP + AI (n = 118). Baseline characteristics were balanced. The study met its primary end point; superior PFS was observed with LAP + TRAS + AI versus TRAS + AI (median PFS, 11 v 5.7 months; hazard ratio, 0.62; 95% CI, 0.45 to 0.88; P = .0064). Consistent PFS benefit was observed in predefined subgroups. Overall response rate, clinical benefit rate, and overall survival also favored LAP + TRAS + AI. The median PFS with LAP + AI versus TRAS + AI was 8.3 versus 5.7 months (hazard ratio, 0.71; 95% CI, 0.51 to 0.98; P = .0361). Common adverse events (AEs; ≥ 15%) with LAP + TRAS + AI, TRAS + AI, and LAP + AI were diarrhea (69%, 9%, and 51%, respectively), rash (36%, 2%, and 28%, respectively), nausea (22%, 9%, and 22%, respectively), and paronychia (30%, 0%, and 15%, respectively), mostly grade 1 or 2. Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI. Conclusion Dual HER2 blockade with LAP + TRAS + AI showed superior PFS benefit versus TRAS + AI in patients with HER2-positive/HR-positive MBC. This combination offers an effective and safe chemotherapy-sparing alternative treatment regimen for this patient population.",2018,"Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI.","['Postmenopausal Women', 'postmenopausal women with HER2-positive/HR-positive MBC who received prior', 'Results Three hundred fifty-five patients were included in this analysis', 'patients with HER2-positive/HR-positive MBC']","['Dual HER2 blockade', 'Blockade With Lapatinib Plus Trastuzumab', 'dual HER2 blockade plus aromatase inhibitor (AI', 'LAP + TRAS + AI versus TRAS + AI', 'LAP + TRAS + AI', 'Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET', 'lapatinib (LAP) + TRAS + AI, TRAS + AI, or LAP + AI', 'TRAS + AI', 'ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy', 'Dual Human Epidermal Growth Factor Receptor 2 (HER2']","['PFS (comparison of other arms), overall survival, overall response rate, clinical benefit rate, and safety', 'Overall response rate, clinical benefit rate, and overall survival', 'diarrhea', 'progression-free survival', 'paronychia', 'superior PFS', 'median PFS', 'nausea', 'rash']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",355.0,0.0970516,"Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI.","[{'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Burdaeva', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Kurteva', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Press', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Sergio D', 'Initials': 'SD', 'LastName': 'Simon', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kenny', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Sarp', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Izquierdo', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Williams', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gradishar', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.74.7824']
790,31611624,Long-term results of all-trans retinoic acid and arsenic trioxide in non-high-risk acute promyelocytic leukemia: update of the APL0406 Italian-German randomized trial.,,2020,,['non-high-risk acute promyelocytic leukemia'],['trans retinoic acid and arsenic trioxide'],[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}]",[],,0.0553994,,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cicconi', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Platzbecker', 'Affiliation': 'Universitätsklinikum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Avvisati', 'Affiliation': 'Ematologia e Trapianto di cellule staminali, Università Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Paoloni', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vignetti', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Fazi', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Felicetto', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': 'Dipartimento di Ematologia e Trapianto di Cellule Staminali, Ospedale Cardarelli, Napoli, Italy.'}, {'ForeName': 'Mariadomenica', 'Initials': 'M', 'LastName': 'Divona', 'Affiliation': 'Laboratorio di Oncoematologia, Policlinico Tor Vergata, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Albano', 'Affiliation': 'Dipartimento di Ematologia, Università di Bari, Bari, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Efficace', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sborgia', 'Affiliation': 'U.O. di Ematologia Clinica, Pescara, Italy.'}, {'ForeName': 'Eros', 'Initials': 'E', 'LastName': 'Di Bona', 'Affiliation': 'Dipartimento di Terapie cellulari ed Ematologia, Unità Operativa di Ematologia, Ospedale S. Bortolo, Vicenza, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Breccia', 'Affiliation': 'Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza, Rome, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borlenghi', 'Affiliation': 'Dipartimento di Ematologia, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cairoli', 'Affiliation': 'Grande Ospedale Metropolitano Niguarda, SC Ematologia, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Melillo', 'Affiliation': 'Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'La Nasa', 'Affiliation': 'Centro Trapianti Midollo Osseo, Ospedale R. Binaghi, Università di Cagliari, Cagliari, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'Department of Oncology, Hematology, Immuno-Oncology and Rheumatology, University Hospital Bonn, CIO Bonn, Bonn, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Helmut R', 'Initials': 'HR', 'LastName': 'Salih', 'Affiliation': 'University Hospital Tubingen, Tubingen, Germany.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Annibali', 'Affiliation': 'Ematologia e Trapianto di cellule staminali, Università Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Kliniken Essen Süd, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lubbert', 'Affiliation': 'University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Brandts', 'Affiliation': 'Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hanel', 'Affiliation': 'Klinikum Chemnitz gGmbH, Chemnitz, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rollig', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Asklepios Klinik St Georg Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Klinik für Innere Medizin I, Westpfalz-Klinikum, Kaiserslautern, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Frairia', 'Affiliation': 'Città della Salute e della Scienza, Hematology, Torino, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Fozza', 'Affiliation': 'University of Sassari, Sassari, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': ""Maria D'Arco"", 'Affiliation': 'U.O. Medicina Interna e Onco-Ematologica P.O. Umberto I, Nocera Inferiore, Nocera Inferiore, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Di Renzo', 'Affiliation': 'Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Cortelezzi', 'Affiliation': ""Foundation Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico and University of Milan, Milan, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fabbiano', 'Affiliation': 'Divisione di Ematologia e Unità di Trapianti di Midollo Osseo, Ospedale Riuniti Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Dohner', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Dohner', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Mandelli', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy. voso@med.uniroma2.it.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'NCT Trial Center, National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lo-Coco', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}]",Leukemia,['10.1038/s41375-019-0589-3']
791,31611626,T-cell acute lymphoblastic leukemia in patients 1-45 years treated with the pediatric NOPHO ALL2008 protocol.,"The NOPHO ALL2008 is a population-based study using an unmodified pediatric protocol in patients 1-45 years of age with acute lymphoblastic leukemia. Patients with T-ALL were given a traditional pediatric scheme if fast responding (minimal residual disease (MRD) < 0.1% day 29), or intensive block-based chemotherapy if slow responding (MRD > 0.1% day 29). Both treatment arms included pediatric doses of high-dose methotrexate and asparaginase. If MRD ≥ 5% on day 29 or ≥0.1% after consolidation, patients were assigned to allogeneic hematopoietic stem cell transplantation. The 5-year overall survival of the 278 T-ALL patients was 0.75 (95% CI 0.69-0.81), being 0.82 (0.74-0.88) for patients 1.0-9.9 years, 0.76 (0.66-0.86) for those 10.0-17.9 years, and 0.65 (0.55-0.75) for the older patients. The risk of death in first remission was significantly higher in adults (12%) compared with the 1-9 years group (4%). The MRD responses in the three age groups were similar, and only a nonsignificant increase in relapse risk was found in adults. In conclusion, an unmodified pediatric protocol in patients 1-45 years is effective in all age groups. The traditional pediatric treatment schedule was safe for all patients, but the intensive block therapy led to a high toxic death rate in adults.",2020,The risk of death in first remission was significantly higher in adults (12%) compared with the 1-9 years group (4%).,['patients 1-45 years of age with acute lymphoblastic leukemia'],"['intensive block-based chemotherapy', 'methotrexate and asparaginase', 'allogeneic hematopoietic stem cell transplantation']","['T-cell acute lymphoblastic leukemia', 'MRD responses', 'toxic death rate', 'relapse risk', '5-year overall survival', 'risk of death in first remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C1961099', 'cui_str': 'Leukemia, Lymphocytic, Acute, T-Cell'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",278.0,0.042444,The risk of death in first remission was significantly higher in adults (12%) compared with the 1-9 years group (4%).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Quist-Paulsen', 'Affiliation': ""Department of Hematology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway. Petter.Quist-Paulsen@ntnu.no.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Toft', 'Affiliation': 'Department of Hematology, Herlev University Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heyman', 'Affiliation': ""Childhood Cancer Research Unit, Karolinska Institute, Astrid Lindgren's Childrens' Hospital, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abrahamsson', 'Affiliation': 'Department of Pediatrics, Institution for Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Griškevičius', 'Affiliation': 'Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hallböök', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ó G', 'Initials': 'ÓG', 'LastName': 'Jónsson', 'Affiliation': ""Children's Hospital, Landspitali University Hospital, Reykjavík, Iceland.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Palk', 'Affiliation': 'Department of Hematology, North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vaitkeviciene', 'Affiliation': ""Centre for Pediatric Oncology and Hematology, Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos, Vilnius University, Vilnius, Lithuania.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vettenranta', 'Affiliation': 'Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Åsberg', 'Affiliation': ""Department of Pediatrics, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Frandsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Opdahl', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Science, NTNU, Trondheim, Norway.'}, {'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Marquart', 'Affiliation': 'Department of Clinical Immunology, Section 7631, University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siitonen', 'Affiliation': 'Department of Clinical Chemistry, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Osnes', 'Affiliation': 'Department of Immunology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hultdin', 'Affiliation': 'Department of Medical Biosciences, Pathology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Overgaard', 'Affiliation': 'Department of Hematology, The University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Wartiovaara-Kautto', 'Affiliation': 'Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.'}]",Leukemia,['10.1038/s41375-019-0598-2']
792,29373687,"Substituting Abacavir for Stavudine in Children Who Are Virally Suppressed Without Lipodystrophy: Randomized Clinical Trial in Johannesburg, South Africa.","Objectives


Abacavir has replaced stavudine in antiretroviral therapy (ART) regimens because it has largely been phased out as a result of toxicity concerns; this loss has reduced further the already-limited drug options for children. Few data regarding virologic and metabolic outcomes among children who undergo substitution of stavudine exist. We evaluated the effects of preemptive substitution of abacavir for stavudine in children initially without lipodystrophy and virally suppressed on a stavudine-containing regimen.
Methods


At Rahima Moosa Mother and Child Hospital in Johannesburg, South Africa, virally suppressed human immunodeficiency virus (HIV)-infected children ≥36 months of age without lipodystrophy were randomly assigned to continue taking stavudine as part of their ART regimen (n = 106) or to have abacavir substituted for stavudine (n = 107). The children were followed for 56 weeks after randomization in the context of a larger trial of treatment options for ART-experienced children.
Results


The mean age of the children was 4.3 years, and the mean duration of ART before random assignment was 3.5 years. No differences in virological outcomes, CD4 response, growth, or dyslipidemia were noted between the stavudine and abacavir groups. By 56 weeks, children in the abacavir group had less clinically detected lipodystrophy (4.7% vs 16%, respectively), a higher proportion of leg fat relative to total fat (0.243 vs 0.230, respectively; P = .006), and a lower trunk/leg-skinfold ratio (0.547 vs 0.569, respectively; P = .003) than the children in the stavudine group.
Conclusion


Substituting abacavir for stavudine did not compromise virological response to treatment and was associated with significantly less lipodystrophy. These results support recommendations that favor abacavir in this population.",2018,"No differences in virological outcomes, CD4 response, growth, or dyslipidemia were noted between the stavudine and abacavir groups.","['Johannesburg, South Africa', 'At Rahima Moosa Mother and Child Hospital in Johannesburg, South Africa, virally suppressed human immunodeficiency virus (HIV)-infected children ≥36 months of age without lipodystrophy', 'children initially without lipodystrophy and virally suppressed on a stavudine-containing regimen', 'Children', 'children who undergo substitution of stavudine exist']","['Stavudine', 'Abacavir', 'Lipodystrophy', 'abacavir substituted for stavudine', 'abacavir', 'stavudine']","['lower trunk/leg-skinfold ratio', 'lipodystrophy', 'virological outcomes, CD4 response, growth, or dyslipidemia', 'leg fat relative to total fat']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023787', 'cui_str': 'Lipodystrophy'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0164662', 'cui_str': 'Stavudine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0164662', 'cui_str': 'Stavudine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0023787', 'cui_str': 'Lipodystrophy'}]","[{'cui': 'C0230094', 'cui_str': 'Lower trunk structure'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023787', 'cui_str': 'Lipodystrophy'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",107.0,0.0559747,"No differences in virological outcomes, CD4 response, growth, or dyslipidemia were noted between the stavudine and abacavir groups.","[{'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Strehlau', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shiau', 'Affiliation': 'Gertrude H. Sergievsky Center, Columbia University.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Arpadi', 'Affiliation': 'Gertrude H. Sergievsky Center, Columbia University.'}, {'ForeName': 'Faeezah', 'Initials': 'F', 'LastName': 'Patel', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Pinillos', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Wei-Yann', 'Initials': 'WY', 'LastName': 'Tsai', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Coovadia', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Columbia University.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Gertrude H. Sergievsky Center, Columbia University.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/pix110']
793,29369834,Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise -Associated Hyponatremia.,"OBJECTIVES


To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon.
DESIGN


Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either ""oral"" or ""IV.""
SETTING


Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada.
PARTICIPANTS


Twenty race finishers with mild to moderately symptomatic EAH.
INDEPENDENT VARIABLES


Age, sex, race finish time, and 9 clinical symptoms.
MAIN OUTCOME MEASURES


Time from treatment to discharge.
METHODS


We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention.
RESULTS


The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
CONCLUSIONS


Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.",2018,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","['Twenty race finishers with mild to moderately symptomatic EAH', 'Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada']","['Oral Hypertonic Saline', 'oral HTS', 'HTS', 'sealed envelopes, containing the word either ""oral"" or ""IV', '3% hypertonic saline (HTS']",['average time'],"[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.145485,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bridges', 'Affiliation': 'Department of Emergency Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Altherwi', 'Affiliation': 'EM FRCP Program-McGill University, Montreal, QC, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hew-Butler', 'Affiliation': 'Oakland University, Rochester, Michigan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000573']
794,29294858,"TakeCARE, a Video to Promote Bystander Behavior on College Campuses: Replication and Extension.","Previous research has demonstrated that college students who view TakeCARE, a video bystander program designed to encourage students to take action to prevent sexual and relationship violence (i.e., bystander behavior), display more bystander behavior relative to students who view a control video. The current study aimed to replicate and extend these findings by testing two different methods of administering TakeCARE and examining moderators of TakeCARE's effects on bystander behavior. Students at four universities ( n  = 557) were randomly assigned to one of three conditions: (a) view TakeCARE in a monitored computer lab, (b) view TakeCARE at their own convenience after receiving an email link to the video, or (c) view a video about study skills (control group). Participants completed measures of bystander behavior at baseline and at a 1-month follow-up. Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition. The beneficial effect of TakeCARE did not differ significantly across administration methods. However, the effects of TakeCARE on bystander behavior were moderated by students' perceptions of campus responsiveness to sexual violence, with more potent effects when students perceived their institution as responsive to reports of sexual violence.",2020,"Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition.","['college students', 'Students at four universities ( n = 557']","['view TakeCARE in a monitored computer lab, (b) view TakeCARE at their own convenience after receiving an email link to the video, or (c) view a video about study skills (control group', 'TakeCARE']",['bystander behavior'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}]",557.0,0.0250129,"Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition.","[{'ForeName': 'Ernest N', 'Initials': 'EN', 'LastName': 'Jouriles', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Kelli S', 'Initials': 'KS', 'LastName': 'Sargent', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Katie Lee', 'Initials': 'KL', 'LastName': 'Salis', 'Affiliation': 'Stony Brook University, NY, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Caiozzo', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cascardi', 'Affiliation': 'William Paterson University, Wayne, NJ, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Grych', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': ""O'Leary"", 'Affiliation': 'Stony Brook University, NY, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}]",Journal of interpersonal violence,['10.1177/0886260517718189']
795,29177238,Comparing the effect of gonadotropin-releasing hormone agonist and human chorionic gonadotropin on final oocytes for ovulation triggering among infertile women undergoing intrauterine insemination: An RCT.,"Background


The purpose of triggering in ovulation induction is to induce the final maturation of oocytes and their release from the ovary for fertilization.
Objective


The aim of the present study was to compare the effectiveness of gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (HCG) on the final maturation of oocytes and pregnancy rates in intrauterine insemination (IUI) cycles.
Materials and Methods


In this randomized clinical trial, 110 infertile women who were selected for IUI entered the study. Ovulation induction was performed. Group I received 0.1 mg GnRH agonist as triggering and group II received 10,000 IU of HCG. The serum E 2 , LH, and FSH levels were measured at 12 and 36 hr after injection.
Results


LH surge was detected in all patients. LH levels at 12 and 36 hr after triggering was higher in Group I and it washed out earlier than group II (p=0.00). The pregnancy rate was higher in Group I, but the difference was not statistically significant (26.9% vs. 20.8%, respectively p=0.46). Also, the incidence of ovarian hyperstimulation syndrome was not different between the two groups (p=0.11). There was a significant difference regarding the estradiol levels at 36 hours after triggering (p=0.00).
Conclusion


Effects of GnRH on endogenous LH surge is sufficient for oocyte releasing and final follicular maturation. Pregnancy rates and ovarian hyperstimulation syndrome incidence were not different between the groups. We suggest that GnRH agonists might be used as an alternative option instead of HCG in IUI cycles.",2017,"Also, the incidence of ovarian hyperstimulation syndrome was not different between the two groups (p=0.11).","['110 infertile women who were selected for IUI entered the study', 'infertile women undergoing intrauterine insemination']","['HCG', 'GnRH', 'gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (HCG', 'gonadotropin-releasing hormone agonist and human chorionic gonadotropin', 'GnRH agonist']","['serum E 2 , LH, and FSH levels', 'pregnancy rate', 'LH levels', 'Ovulation induction', 'estradiol levels', 'Pregnancy rates and ovarian hyperstimulation syndrome incidence', 'LH surge', 'incidence of ovarian hyperstimulation syndrome']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}]","[{'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement (procedure)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0029967', 'cui_str': 'Ovulation Induction'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",110.0,0.164844,"Also, the incidence of ovarian hyperstimulation syndrome was not different between the two groups (p=0.11).","[{'ForeName': 'Robabeh', 'Initials': 'R', 'LastName': 'Taheripanah', 'Affiliation': 'Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Zamaniyan', 'Affiliation': 'Infertility Center, Department of Obstetrics and Gynecology, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Moridi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Taheripanah', 'Affiliation': 'Department of Molecular and Cellular Sciences, Faculty of Advanced Sciences and Technology, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Malih', 'Affiliation': 'Department of Health and Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
796,29177240,Polycystic ovary syndrome and circulating inflammatory markers.,"Background


Human and experimental studies suggest that the sympathetic regulatory drive in the ovary may be unbalanced (hyperactivity) in polycystic ovary syndrome (PCOS). Dysfunctional secretion of interleukin (IL) -1 (α & β) or related cytokines may thus be related to abnormal ovulation and luteinization.
Objective


The aim of this study was the evaluation of cytokines' pattern in PCOS women and discussion about the explanation of cross-talk between two super systems: sympathetic and immune systems and explanation sympatho-excitation and relationship with interleukins.
Materials and Methods


In this study, 171 PCOS women aged between 20-40 years were studied the. Their body mass index was <28. The patients were divided into two groups: study group (n=85, PCOS women) and control group (n=86 normal women). The blood sample was obtained on the 3 rd  day of menstruation cycle. IL-17, IL-1α, IL-1β, and TNF-α concentrations were determined in both groups.
Results


The median serum level of IL-1α in the PCOS group was higher than the control group (293.3 and 8.0, respectively, p<0.001). Also, the median serum level of IL-1β was higher than the control group (5.9 and 3.1 respectively). But the median serum of level IL-17 in women with PCOS was significantly lower than the control group (p<0.001).
Conclusion


Our results confirm that PCOS is a low-level chronic inflammation.",2017,"The median serum level of IL-1α in the PCOS group was higher than the control group (293.3 and 8.0, respectively, p<0.001).","['n=86 normal women', '171 PCOS women aged between 20-40 years']","['control group', 'PCOS']","['median serum of level IL-17', 'TNF-α concentrations', 'median serum level of IL-1α', 'IL-17, IL-1α, IL-1β, and', 'median serum level of IL-1β', 'Dysfunctional secretion of interleukin (IL) -1', 'Polycystic ovary syndrome and circulating inflammatory markers', 'blood sample']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",171.0,0.0724253,"The median serum level of IL-1α in the PCOS group was higher than the control group (293.3 and 8.0, respectively, p<0.001).","[{'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Zafari Zangeneh', 'Affiliation': 'Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Naghizadeh', 'Affiliation': 'Noncommunicable Diseases Research, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Masoumi', 'Affiliation': 'Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
797,32414547,Efficacy of botulinum toxin for treating a gummy smile.,"INTRODUCTION


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


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


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


For gummy smile correction, botulinum toxin injection is thought to be an alternative method because it is effective and conservative and has high patient satisfaction.",2020,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"['patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value', 'Twenty-eight patients who had a gummy smile of more than 2\xa0mm']","['botulinum toxin', 'Botulinum toxin', 'botulinum toxin injection']","['visual analogue scale', 'satisfaction', 'average amount of visible gingiva', 'gingival appearances', 'return to baseline gingival exposure value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C3696916', 'cui_str': 'Gummy smile'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0146754,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"[{'ForeName': 'Ahmet Fatih', 'Initials': 'AF', 'LastName': 'Cengiz', 'Affiliation': 'Private Practice, Mersin, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Goymen', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Gaziantep University, Gaziantep, Turkey. Electronic address: mervegoymen@gmail.com.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Akcali', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Gaziantep University, Gaziantep, Turkey.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.014']
798,31575503,"Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial.","BACKGROUND


Trilaciclib is an intravenous cell-cycle inhibitor that transiently maintains immune cells and haemopoietic stem and progenitor cells in G1 arrest. By protecting the immune cells and bone marrow from chemotherapy-induced damage, trilaciclib has the potential to optimise antitumour activity while minimising myelotoxicity. We report safety and activity data for trilaciclib plus gemcitabine and carboplatin chemotherapy in patients with metastatic triple-negative breast cancer.
METHODS


In this randomised, open-label, multicentre, phase 2 study, adult patients (aged ≥18 years) with evaluable, biopsy-confirmed, locally recurrent or metastatic triple-negative breast cancer who had no more than two previous lines of chemotherapy were recruited from 26 sites in the USA, three in Serbia, two in North Macedonia, one in Croatia, and one in Bulgaria; sites were academic and community hospitals. Availability of diagnostic samples of tumour tissue confirming triple-negative breast cancer was a prerequisite for enrolment. Eligible patients were randomly assigned (1:1:1) by an interactive web-response system, stratified by number of previous lines of systemic therapy and the presence of liver metastases, to receive intravenous gemcitabine 1000 mg/m 2  and intravenous carboplatin (area under the concentration-time curve 2 μg × h/mL) on days 1 and 8 (group 1), gemcitabine and carboplatin plus intravenous trilaciclib 240 mg/m 2  on days 1 and 8 (group 2), or gemcitabine and carboplatin on days 2 and 9 plus trilaciclib on days 1, 2, 8, and 9 (group 3) of 21-day cycles. Patients continued treatment until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation by the investigator. The primary objective was to assess the safety and tolerability of combining trilaciclib with gemcitabine and carboplatin chemotherapy. The primary endpoints were duration of severe neutropenia during cycle 1 and the occurrence of severe neutropenia during the treatment period. Overall survival was included as a key secondary endpoint. Analyses were in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This study is registered with EudraCT, 2016-004466-26, and ClinicalTrials.gov, NCT02978716, and is ongoing but closed to accrual.
FINDINGS


Between Feb 7, 2017, and May 15, 2018, 142 patients were assessed for eligibility and 102 were randomly assigned to group 1 (n=34), group 2 (n=33), or group 3 (n=35). Of all patients, 38 (37%) had received one or two lines of previous chemotherapy in the metastatic setting. Median follow-up was 8·4 months (IQR 3·8-13·6) for group 1, 12·7 months (5·5-17·4) for group 2, and 12·9 months (6·7-16·8) for group 3. Data cutoff for myelosuppression endpoints was July 30, 2018, and for antitumour activity endpoints was May 17, 2019. During cycle 1, mean duration of severe neutropenia was 0·8 day (SD 2·4) in group 1, 1·5 days (3·5) in group 2, and 1·0 day (2·6) in group 3 (group 3 vs group 1 one-sided adjusted p=0·70). Severe neutropenia occurred in nine (26%) of 34 patients in group 1, 12 (36%) of 33 patients in group 2, and eight (23%) of 35 patients in group 3 (p=0·70). Overall survival was 12·6 months (IQR 5·8-15·6) in group 1, 20·1 months (9·4-not reached) in group 2, and 17·8 months (8·8-not reached) in group 3 (group 3 vs group 1 two-sided p=0·0023). The most common treatment-emergent adverse events were anaemia (22 [73%] of 34), neutropenia (21 [70%]), and thrombocytopenia (18 [60%]) in group 1; neutropenia (27 [82%] of 33), thrombocytopenia (18 [55%]) and anaemia (17 [52%]) in group 2; and neutropenia (23 [66%] of 35), thrombocytopenia (22 [63%]), and nausea (17 [49%]) in group 3. There were no treatment-related deaths.
INTERPRETATION


No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging. Further studies of trilaciclib in this setting are warranted.
FUNDING


G1 Therapeutics.",2019,"No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging.","['Between Feb 7, 2017, and May 15, 2018', '142 patients were assessed for eligibility and 102', 'adult patients (aged ≥18 years) with evaluable, biopsy-confirmed, locally recurrent or metastatic triple-negative breast cancer who had no more than two previous lines of chemotherapy were recruited from 26 sites in the USA, three in Serbia, two in North Macedonia, one in Croatia, and one in Bulgaria; sites were academic and community hospitals', 'Of all patients, 38 (37%) had received one or two lines of previous chemotherapy in the metastatic setting', 'patients with metastatic triple-negative breast cancer', 'Eligible patients']","['gemcitabine and carboplatin chemotherapy', 'gemcitabine and carboplatin plus intravenous trilaciclib 240 mg/m 2  on days 1 and 8 (group 2), or gemcitabine and carboplatin', 'chemotherapy alone', 'gemcitabine 1000 mg/m 2  and intravenous carboplatin', 'Trilaciclib plus chemotherapy', 'trilaciclib plus gemcitabine and carboplatin chemotherapy', 'gemcitabine and carboplatin']","['Safety', 'anaemia', 'Severe neutropenia', 'neutropenia', 'myelosuppression endpoints', 'unacceptable toxicity, withdrawal of consent, or discontinuation', 'mean duration of severe neutropenia', 'nausea', 'tolerated and overall survival', 'thrombocytopenia', 'Overall survival', 'duration of severe neutropenia during cycle 1 and the occurrence of severe neutropenia', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0206004', 'cui_str': 'Macedonia, Former Yugoslave Republic of'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",142.0,0.0748289,"No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging.","[{'ForeName': 'Antoinette R', 'Initials': 'AR', 'LastName': 'Tan', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC, USA. Electronic address: antoinette.tan@atriumhealth.org.'}, {'ForeName': 'Gail S', 'Initials': 'GS', 'LastName': 'Wright', 'Affiliation': 'Florida Cancer Specialists and Research Institute, New Port Richey, FL, USA.'}, {'ForeName': 'Anu R', 'Initials': 'AR', 'LastName': 'Thummala', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Danso', 'Affiliation': 'Virginia Oncology Associates, Norfolk, VA, USA.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Popovic', 'Affiliation': 'Oncology Institute of Vojvodina, University of Novi Sad, Serbia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Pluard', 'Affiliation': ""Saint Luke's Cancer Institute, Kansas City, MO, USA.""}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Vojnović', 'Affiliation': 'Varaždin General Hospital, Varaždin, Croatia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Vasev', 'Affiliation': 'University Clinic of Radiotherapy and Oncology, Skopje, Macedonia.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Rocky Mountain Cancer Centers, Lakewood, CO, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology-Tyler, US Oncology Research, Tyler, TX, USA.'}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Wilks', 'Affiliation': 'Texas Oncology-San Antonio, US Oncology Research, San Antonio, TX, USA.'}, {'ForeName': 'Dušan', 'Initials': 'D', 'LastName': 'Milenković', 'Affiliation': 'Clinical Center Niš, Niš, Serbia.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Antal', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology Dallas, US Oncology Research, Dallas, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30616-3']
799,31600365,Efficacy and Safety of Trifluridine/Tipiracil Treatment in Patients With Metastatic Gastric Cancer Who Had Undergone Gastrectomy: Subgroup Analyses of a Randomized Clinical Trial.,"Importance


Trifluridine/tipiracil (FTD/TPI) treatment has shown clinical benefit in patients with pretreated metastatic gastric cancer or gastroesophageal junction cancer (mGC/GEJC). Patients who have undergone gastrectomy constitute a significant proportion of patients with mGC/GEJC.
Objective


To assess the efficacy and safety of FTD/TPI among patients with previously treated mGC/GEJC who had or had not undergone gastrectomy.
Design, Setting, and Participants


This preplanned subgroup analysis of TAGS (TAS-102 Gastric Study), a phase 3, randomized, placebo-controlled, clinical trial included patients with mGC/GEJC who had received at least 2 previous chemotherapy regimens, and was conducted at 110 academic hospitals in 17 countries in Europe, Asia, and North America, with enrollment between February 24, 2016, and January 5, 2018; the data cutoff was March 31, 2018.
Interventions


Patients were randomized 2:1 to receive oral FTD/TPI 35 mg/m2 twice daily or placebo twice daily with best supportive care on days 1 through 5 and days 8 through 12 of each 28-day treatment cycle.
Main Outcomes and Measures


The primary end point was overall survival. This subgroup analysis was conducted to examine potential trends and was not powered for statistical significance. Efficacy and safety end points were evaluated in the subgroups.
Results


Of 507 randomized patients (369 [72.8%] male; mean [SD] age, 62.5 [10.5] years), 221 (43.6%) had undergone gastrectomy (147 randomized to FTD/TPI and 74 to placebo) and 286 (56.4%) had not undergone gastrectomy (190 randomized to FTD/TPI and 96 to placebo). In the gastrectomy subgroup, the overall survival hazard ratio (HR) in the FTD/TPI group vs placebo group was 0.57 (95% CI, 0.41-0.79), and the progression-free survival HR was 0.48 (95% CI, 0.35-0.65). In the no gastrectomy subgroup, the overall survival HR in the FTD/TPI group vs placebo group was 0.80 (95% CI, 0.60-1.06), and the progression-free survival HR was 0.65 (95% CI, 0.49-0.85). Among FTD/TPI-treated patients, grade 3 or higher adverse events of any cause occurred in 122 of 145 patients (84.1%) in the gastrectomy subgroup and 145 of 190 (76.3%) in the no gastrectomy subgroup: 64 (44.1%) in the gastrectomy subgroup and 50 (26.3%) in the no gastrectomy subgroup had grade 3 or higher neutropenia, 31 (21.4%) in the gastrectomy subgroup and 33 (17.4%) in the no gastrectomy subgroup had grade 3 or higher anemia, and 21 (14.5%) in the gastrectomy subgroup and 10 (5.3%) in the no gastrectomy subgroup hD grade 3 or higher leukopenia. In the gastrectomy subgroup, 94 (64.8%) had dosing modifications because of adverse events vs 101 (53.2%) in the no gastrectomy subgroup; 15 (10.3%) in the gastrectomy group and 28 (14.7%) in the no gastrectomy group discontinued treatment because of adverse events. Treatment exposure was similar between groups.
Conclusions and Relevance


The FTD/TPI treatment was tolerable and provided efficacy benefits among patients with pretreated mGC/GEJC regardless of previous gastrectomy.
Trial Registration


ClinicalTrials.gov identifier: NCT02500043.",2019,"Conclusions and Relevance


The FTD/TPI treatment was tolerable and provided efficacy benefits among patients with pretreated mGC/GEJC regardless of previous gastrectomy.
","['patients with mGC/GEJC who had received at least 2 previous chemotherapy regimens, and was conducted at 110 academic hospitals in 17 countries in Europe, Asia, and North America, with enrollment between February 24, 2016, and January 5, 2018; the data cutoff was March 31, 2018', 'patients with previously treated mGC/GEJC who had or had not undergone gastrectomy', 'patients with pretreated metastatic gastric cancer or gastroesophageal junction cancer (mGC/GEJC', '507 randomized patients (369 [72.8%] male', 'patients with pretreated mGC/GEJC regardless of previous gastrectomy', 'mean [SD] age, 62.5 [10.5] years), 221 (43.6%) had undergone gastrectomy (147 randomized to FTD/TPI and 74 to placebo) and 286 (56.4%) had not undergone gastrectomy (190 randomized to FTD/TPI and 96 to', 'Patients With Metastatic Gastric Cancer', 'Patients who have undergone gastrectomy constitute a significant proportion of patients with mGC/GEJC']","['FTD/TPI', 'Undergone Gastrectomy', 'placebo', 'Trifluridine/Tipiracil Treatment', 'oral FTD/TPI 35 mg/m2 twice daily or placebo', 'Trifluridine/tipiracil (FTD/TPI']","['leukopenia', 'adverse events', 'efficacy and safety', 'overall survival', 'overall survival HR', 'grade 3 or higher neutropenia', 'Efficacy and Safety', 'grade 3 or higher anemia', 'progression-free survival HR', 'Efficacy and safety end points', 'overall survival hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]","[{'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",507.0,0.365525,"Conclusions and Relevance


The FTD/TPI treatment was tolerable and provided efficacy benefits among patients with pretreated mGC/GEJC regardless of previous gastrectomy.
","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Aliaksandr', 'Initials': 'A', 'LastName': 'Prokharau', 'Affiliation': 'Department of Oncology, Minsk City Clinical Oncology Dispensary, Minsk, Belarus.'}, {'ForeName': 'Hendrik-Tobias', 'Initials': 'HT', 'LastName': 'Arkenau', 'Affiliation': 'Drug Development Unit, Sarah Cannon Research Institute, Cancer Institute, University College London, London, United Kingdom.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ghidini', 'Affiliation': 'Department of Oncology, Azienda Ospedaliera di Cremona, Cremona, Italy.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, University Hospitals Gasthuisberg Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Giordano D', 'Initials': 'GD', 'LastName': 'Beretta', 'Affiliation': 'Department of Oncology, Humanitas Gavazzeni, Bergamo, Italy.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'Department of Chemotherapy, Alexandrov National Cancer Centre of Belarus, Minsk, Belarus.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'George', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'McGuigan', 'Affiliation': 'Medical Affairs Division, Taiho Oncology Inc, Princeton, New Jersey.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Makris', 'Affiliation': 'Stathmi Inc, New Hope, Pennsylvania.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.'}]",JAMA oncology,['10.1001/jamaoncol.2019.3531']
800,28280800,Clomiphene citrate versus letrozole with gonadotropins in intrauterine insemination cycles: A randomized trial.,"BACKGROUND


Clomiphene citrate is one of the effective drugs for infertility treatment due to oligo-ovulation or anovulation. Intrauterine insemination (IUI) is one of more adherent methods for treatment of infertile cases which is followed by controlled ovarian hyperstimulation (COH).
OBJECTIVE


the aim of this study was to evaluate Clomiphene citrate versus letrozole with gonadotropins in IUI cycles.
MATERIALS AND METHODS


In this prospective randomized trial, 180 infertile women who were referred to Milad Hospital were selected. The first group received 5 mg/day letrozole on day 3-7 of menstrual cycle. The second group received 100 mg/day Clomiphene in the same way as letrozole. In both groups, human menopausal gonadotropin was administered every day starting on day between 6-8 of cycle. Ovulation was triggered with urinary Human Chorionic Gonadotropin (5000 IU) when have two follicles of ≥16 mm. IUI was performed 36 hr later.
RESULTS


The number of matured follicles, cycle cancellation, and abortion were the same in both groups. Endometrial thickness was higher at the time of human menopausal gonadotropin administration in letrozole group. Chemical and clinical pregnancy rates were much higher in letrozole group. Ovarian hyperstimulation was significantly higher in clomiphene group.
CONCLUSION


Letrozole appears to be a good alternative to clomiphene citrate with fewer side effects.",2017,"Ovarian hyperstimulation was significantly higher in clomiphene group.
","['180 infertile women who were referred to Milad Hospital were selected', 'intrauterine insemination cycles']","['Letrozole', 'human menopausal gonadotropin', 'urinary Human Chorionic Gonadotropin', 'Intrauterine insemination (IUI', 'Clomiphene citrate versus letrozole with gonadotropins', 'clomiphene', 'Clomiphene citrate versus letrozole', 'letrozole', 'Clomiphene', 'Clomiphene citrate']","['Chemical and clinical pregnancy rates', 'number of matured follicles, cycle cancellation, and abortion', 'Endometrial thickness', 'Ovarian hyperstimulation', 'Ovulation']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0549383', 'cui_str': 'Hyperstimulation of ovaries (disorder)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",180.0,0.0343668,"Ovarian hyperstimulation was significantly higher in clomiphene group.
","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Pourali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Ayati', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Tavakolizadeh', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hourieh', 'Initials': 'H', 'LastName': 'Soleimani', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Teimouri Sani', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
801,28099979,Milrinone Pharmacokinetics and Pharmacodynamics in Neonates with Persistent Pulmonary Hypertension of the Newborn.,"Objective  To describe the pharmacokinetics and pharmacodynamics of milrinone in infants with persistent pulmonary hypertension of the newborn (PPHN) and to explore the impact of age on milrinone disposition.  Design  Randomized, open label pilot study.  Setting  Multicenter; level 3 and level 4 neonatal intensive care units.  Patients  Six infants ≥34 weeks' gestational age and  < 10 days of life with persistent hypoxemia receiving inhaled nitric oxide.  Intervention  Intravenous milrinone lactate in one of two dosing regimens: (1) low dose, 20 mcg/kg bolus followed by 0.2 mcg/kg/minute, and (2) standard dose, 50 mcg/kg bolus followed by 0.5 mcg/kg/minute.  Measurements and Main Results  The final structural model was a two-compartment disposition model with interindividual variability estimated on clearance (CL). The estimated value of CL is 7.65 mL/minute/3.4 kg (3.05 mL/minute/kg). The addition of age improved the precision of the CL estimate, and CL increased with chronological age in days. The oxygenation index was highly variable within each participant and improved with time. There were no observed safety concerns in either dosing group.  Conclusion  The CL of milrinone in newborns with PPHN is reduced and increases with age. In this pilot study, we did not see significant pharmacodynamic or safety effects associated with drug exposure.",2017,There were no observed safety concerns in either dosing group.  ,"[""Six infants ≥34 weeks' gestational age and  < 10 days of life with persistent hypoxemia receiving inhaled nitric oxide"", 'infants with persistent pulmonary hypertension of the newborn (PPHN', 'Patients', 'Neonates with Persistent Pulmonary Hypertension of the Newborn', 'newborns with PPHN']","['Milrinone Pharmacokinetics and Pharmacodynamics', 'Intravenous milrinone lactate', 'milrinone']","['oxygenation index', 'clearance (CL', 'precision of the CL estimate, and CL']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0031190', 'cui_str': 'Misalignment of the Pulmonary Vessels'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0600487', 'cui_str': 'Milrinone Lactate'}]","[{'cui': 'C1278185', 'cui_str': 'Oxygenation index'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.126195,There were no observed safety concerns in either dosing group.  ,"[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Giaccone', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Athena F', 'Initials': 'AF', 'LastName': 'Zuppa', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Sood', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Michigan and Wayne State University School of Medicine, Detroit, Michigan.""}, {'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': ""O'Byrne"", 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Moorthy', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': ""Department of Pediatrics, St. Louis Children's Hospital and Washington University School of Medicine, St. Louis, Missouri.""}, {'ForeName': 'Haresh', 'Initials': 'H', 'LastName': 'Kirpalani', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.""}]",American journal of perinatology,['10.1055/s-0036-1597996']
802,27922145,Drainless Parotidectomies versus Conventional Parotidectomies: Randomised Control Study on Efficacy and Safety.,,2016,,[],['Conventional Parotidectomies'],['Efficacy and Safety'],[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0418799,,"[{'ForeName': 'Dennis Yk', 'Initials': 'DY', 'LastName': 'Chua', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Christopher Hk', 'Initials': 'CH', 'LastName': 'Goh', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
803,31859599,Intra-Rater Reliability and Agreement of the Indurometer When Used to Assess Mid-Calf Tissue Compressibility Among People Affected by Moderate to Severe Lymphedema in Bangladesh and Ethiopia.,"Background:  Lymphedema is a chronic skin disease that induces tissue fibrosis (stiffness). Tissue tonometry has been used to assess skin and tissue compressibility in lymphedema, primarily in research on arm lymphedema after breast cancer. A digital tonometer, the Indurometer (Flinders and SA Biomedical Engineering, Australia), has shown excellent intra-rater reliability in young healthy people in Australia and Myanmar and was able to detect covert changes in young, asymptomatic Myanmar people infected with lymphatic filariasis. It has not been tested in overt lower-limb lymphedema.  Methods and Results:  The Indurometer was used in a cluster randomized trial in Bangladesh and Ethiopia to measure tissue compressibility among adults affected by moderate to severe lymphatic filariasis- or podoconiosis-related leg lymphedema. The study compared different self-care intervention and after baseline there were follow-ups at 4, 12, and 24 weeks. Three consecutive Indurometer scores were collected by two data collection teams in each country at the mid-calf of each leg. Indurometer scores were available for three time-points in Bangladesh and four time-points in Ethiopia. An intra-class correlation coefficient (ICC) was calculated for each data collection team, and a coefficient of variation (CV) was used to assess measurement agreement in moderate and severe stages of lymphedema. The intra-rater reliability among local research assistants was good to excellent in both countries at all time-points (ICC range 0.829 [95% confidence interval; CI 0.730-0.896]-0.992 [95% CI 0.989-0.995]). In Bangladesh, agreement between measures was highest among unaffected legs (range 16%-22%) and lowest in severe lymphedema (range 19%-39%). CV scores in Ethiopia showed no distinct pattern for lymphedema stage (range 15%-32%).  Conclusion:  The Indurometer is an inexpensive and easy-to-use device to assess skin and tissue compressibility and should be considered in clinical research on lower-limb lymphedema.",2020,"In Bangladesh, agreement between measures was highest among unaffected legs (range 16%-22%) and lowest in severe lymphedema (range 19%-39%).","['young healthy people in Australia and Myanmar', 'adults affected by moderate to severe lymphatic filariasis- or podoconiosis-related leg lymphedema']",[],"['Mid-Calf Tissue Compressibility', 'CV scores', 'severe lymphedema']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013884', 'cui_str': 'Bancroftian Elephantiasis'}, {'cui': 'C1280469', 'cui_str': 'Lymphostatic Verrucosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]",[],"[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]",,0.0395787,"In Bangladesh, agreement between measures was highest among unaffected legs (range 16%-22%) and lowest in severe lymphedema (range 19%-39%).","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Douglass', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Mableson', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Martindale', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Jahirul', 'Initials': 'J', 'LastName': 'Karim', 'Affiliation': 'Bangladesh Ministry of Health and Family Welfare, Filariasis Elimination Program, Dhaka, Bangladesh.'}, {'ForeName': 'Asm Sultan', 'Initials': 'AS', 'LastName': 'Mahmood', 'Affiliation': 'Bangladesh Ministry of Health and Family Welfare, Filariasis Elimination Program, Dhaka, Bangladesh.'}, {'ForeName': 'Fikre', 'Initials': 'F', 'LastName': 'Hailekiros', 'Affiliation': 'National Podoconiosis Action Network, Addis Ababa, Ethiopia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kelly-Hope', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0060']
804,29091516,Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial.,"Purpose Bosutinib is a potent dual SRC/ABL kinase inhibitor approved for adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) resistant and /or intolerant to prior therapy. We assessed the efficacy and safety of bosutinib versus imatinib for first-line treatment of chronic-phase CML. Methods In this ongoing, multinational, phase III study, 536 patients with newly diagnosed chronic-phase CML were randomly assigned 1:1 to receive 400 mg of bosutinib once daily (n = 268) or imatinib (n = 268). Per protocol, efficacy was assessed in patients who were Philadelphia chromosome-positive with typical (e13a2/e14a2) transcripts (bosutinib, n = 246; imatinib, n = 241). Patients with Philadelphia chromosome-negative-/ BCR-ABL1-positive status and those with unknown Philadelphia chromosome status and/or atypical BCR-ABL1 transcript type were excluded from this population. Results The major molecular response (MMR) rate at 12 months (primary end point) was significantly higher with bosutinib versus imatinib (47.2% v 36.9%, respectively; P = .02), as was complete cytogenetic response (CCyR) rate by 12 months (77.2% v 66.4%, respectively; P = .0075). Cumulative incidence was favorable with bosutinib (MMR: hazard ratio, 1.34; P = .0173; CCyR: hazard ratio, 1.38; P < .001), with earlier response times. Four patients (1.6%) receiving bosutinib and six patients (2.5%) receiving imatinib experienced disease progression to accelerated/blast phase. Among treated patients, 22.0% of patients receiving bosutinib and 26.8% of patients receiving imatinib discontinued treatment, most commonly for drug-related toxicity (12.7% and 8.7%, respectively). Grade ≥ 3 diarrhea (7.8% v 0.8%) and increased ALT (19.0% v 1.5%) and AST (9.7% v 1.9%) levels were more common with bosutinib. Cardiac and vascular toxicities were uncommon. Conclusion Patients who received bosutinib had significantly higher rates of MMR and CCyR and achieved responses faster than those who received imatinib. Consistent with the known safety profile, GI events and transaminase elevations were more common with bosutinib. Results indicate bosutinib may be an effective first-line treatment for chronic-phase CML.",2018,"Cumulative incidence was favorable with bosutinib (MMR: hazard ratio, 1.34; P = .0173; CCyR: hazard ratio, 1.38; P < .001), with earlier response times.","['536 patients with newly diagnosed chronic-phase CML', 'Newly Diagnosed Chronic Myeloid Leukemia', 'Patients with Philadelphia chromosome-negative-/ BCR-ABL1-positive status and those with unknown Philadelphia chromosome status and/or atypical BCR-ABL1 transcript type', 'patients who were Philadelphia chromosome-positive with typical (e13a2/e14a2) transcripts (bosutinib, n = 246; imatinib, n = 241', 'adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) resistant and /or intolerant to prior therapy']","['imatinib', 'Bosutinib Versus Imatinib']","['safety profile, GI events and transaminase elevations', 'disease progression', 'Cardiac and vascular toxicities', 'cytogenetic response', 'major molecular response (MMR) rate', 'CCyR) rate', 'toxicity', 'ALT', 'rates of MMR and CCyR', 'efficacy and safety', 'Grade ≥ 3 diarrhea', 'Cumulative incidence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C3888511', 'cui_str': 'Philadelphia chromosome negative'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0457339', 'cui_str': 'Philadelphia chromosome status (qualifier value)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C1831731', 'cui_str': 'bosutinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1831731', 'cui_str': 'bosutinib'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",536.0,0.0701225,"Cumulative incidence was favorable with bosutinib (MMR: hazard ratio, 1.34; P = .0173; CCyR: hazard ratio, 1.38; P < .001), with earlier response times.","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Gambacorti-Passerini', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Deininger', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mauro', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chuah', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Dyagil', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Glushko', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'le Coutre', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Garcia-Gutierrez', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Reilly', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Jeynes-Ellis', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leip', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bardy-Bouxin', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': ""Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil, National Research Center for Radiation Medicine, Kiev; Nataliia Glushko, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine; Dragana Milojkovic, Imperial College London at Hammersmith Hospital London; Laurence Reilly and Allison Jeynes-Ellis, Avillion, London, United Kingdom; Philipp le Coutre, Charité-Universitätsmedizin Berlin, Berlin; Andreas Hochhaus, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena; Tim H. Brümmendorf, Universitätsklinikum RWTH Aachen, Aachen, Germany; Valentin Garcia-Gutierrez, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Eric Leip, Pfizer, Cambridge, MA; Nathalie Bardy-Bouxin, Pfizer International Operation, Paris, France.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.74.7162']
805,32412986,"Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial.","BACKGROUND


After caesarean section, maternal postoperative comfort is critical to allow the new mother to care for her baby. Insufficient pain relief during the postoperative period may delay maternal/infant bonding and, in addition, such pain has been linked to subsequent depression and chronic pain. Caesarean section is commonly performed with a Pfannenstiel incision, and a transversalis fascia plane (TFP) block provides postoperative analgesia in the T12 and L1 dermatomes.
OBJECTIVE


The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing caesarean section under spinal anaesthesia.
DESIGN


A randomised controlled, double-blind study.
SETTINGS


Single-centre, academic hospital.
PARTICIPANTS


Sixty patients undergoing caesarean section.
INTERVENTIONS


The TFP group (n = 30) received an ultrasound-guided bilateral TFP block with 20 ml of 0.25% bupivacaine. The control group (n = 30) received 20 ml of saline bilaterally. Postoperative analgesia was given every 6 h with intravenous paracetamol 1 g and patient-controlled analgesia (PCA) with morphine.
MAIN OUTCOME MEASURES


Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects were evaluated.
RESULTS


In the TFP group, the visual analogue pain scores were significantly lower at rest for 2 h after the operation (P = 0.011) and during active movement at 2, 4 and 8 h postoperatively (P = 0.014, <0.001 and 0.032, respectively). Morphine consumption in the first 24 h after surgery was significantly higher in the control group compared with the TFP group (38.5 ± 11.63 and 19.5 ± 8.33 mg, respectively; P < 0.001). The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05). Patient satisfaction was significantly higher in the TFP group (P = 0.027).
CONCLUSION


A postoperative TFP block can reduce opioid consumption and relieve acute pain after a caesarean section under spinal anaesthesia.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04172727.",2020,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"['Single-centre, academic hospital', 'patients undergoing caesarean section under spinal anaesthesia', 'caesarean section', 'Sixty patients undergoing caesarean section']","['transversalis fascia plane (TFP) block', 'ultrasound-guided bilateral TFP block with 20\u200aml of 0.25% bupivacaine', 'paracetamol 1 g and patient-controlled analgesia (PCA) with morphine', 'TFP', 'Subarachnoid block and ultrasound-guided transversalis fascia plane block', '20\u200aml of saline bilaterally', 'TFP block', 'placebo']","['Patient satisfaction', 'postoperative opioid consumption and pain scores', 'postoperative nausea and constipation', 'visual analogue pain scores', 'Morphine consumption', 'Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects', 'acute pain']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",60.0,0.485841,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"[{'ForeName': 'Muhammed E', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'From the Department of Anaesthesiology and Reanimation, Ataturk University Faculty of Medicine (MEA, AMY, ECC, IA, EOA, AA), Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine (MEA, AMY, ECC, AA), and Nenehatun State Hospital, Erzurum, Turkey (ZB).'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Bedir', 'Affiliation': ''}, {'ForeName': 'Ahmet M', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': ''}, {'ForeName': 'Erkan C', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': ''}, {'ForeName': 'İrem', 'Initials': 'İ', 'LastName': 'Ates', 'Affiliation': ''}, {'ForeName': 'Elif O', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001222']
806,31370981,Smokers with opioid use disorder may have worse drug use outcomes after varenicline than nicotine replacement.,"INTRODUCTION


Smokers with opioid use disorder (OUD) have little success with smoking cessation, possibly due to interactions between nicotine and opioid receptor systems. Smokers with OUD versus non-opioid substance use disorders (NOUD) have not been compared for response to smoking treatment. Data to make this comparison came from our previous study of 12 weeks (plus dose run-up) of varenicline (VAR) versus 12 weeks of nicotine patch (NRT), in a double-placebo design.
METHODS


The current study reports secondary analyses comparing smokers with OUD (n = 47) and NOUD (n = 90) on pretreatment smoking, alcohol and drug use, intolerance of physical discomfort, smoking medication adherence, and 3- and 6-month smoking and substance use outcomes (by VAR versus NRT).
RESULTS


Smokers with OUD did not differ on pretreatment alcohol or smoking measures while reporting significantly more drug use days. Smokers with OUD versus NOUD had significantly fewer days adherent to VAR or placebo capsules but not to patches, and were more tolerant of physical discomfort. While smoking and heavy drinking days at follow-ups did not differ by diagnosis, smokers with OUD had significantly more drug use days in months 4-6 when assigned to VAR (16.4 days) than to NRT (8.1 days).
CONCLUSIONS


NRT might be a better choice than VAR for smokers with OUD due to lower adherence and more drug use days with VAR. However, this novel comparison of smoking pharmacotherapy response in smokers with OUD versus NOUD needs to be confirmed with larger numbers of participants.",2019,"Smokers with OUD versus NOUD had significantly fewer days adherent to VAR or placebo capsules but not to patches, and were more tolerant of physical discomfort.","['Smokers with opioid use disorder (OUD', 'smokers with OUD (n\u202f=\u202f47) and NOUD (n\u202f=\u202f90) on pretreatment smoking, alcohol and drug use, intolerance of physical discomfort, smoking medication adherence, and 3- and 6-month smoking and substance use outcomes (by VAR versus NRT', 'Smokers with opioid use disorder', 'Smokers with OUD versus non-opioid substance use disorders (NOUD']","['nicotine patch (NRT', 'varenicline (VAR', 'varenicline']",['tolerant of physical discomfort'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",,0.0187383,"Smokers with OUD versus NOUD had significantly fewer days adherent to VAR or placebo capsules but not to patches, and were more tolerant of physical discomfort.","[{'ForeName': 'Rosemarie A', 'Initials': 'RA', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Damaris J', 'Initials': 'DJ', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, USA. Electronic address: Damaris_Rohsenow@Brown.edu.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.06.005']
807,28835936,N-acetyl cysteine in ovulation induction of PCOS women underwent intrauterine insemination: An RCT.,"BACKGROUND


N-acetyl cysteine (NAC) was proposed as an adjuvant to clomiphene citrate for ovulation induction in patients with polycystic ovary syndrome (PCOS) without clomiphene citrate resistance.
OBJECTIVE


To evaluate the effect of NAC on pregnancy rate in PCOS patients who were candidates for intrauterine insemination.
MATERIALS AND METHODS


In this randomized clinical trial, 97 PCOS women aged 18-38 years were enrolled in two groups, randomly. For the case group (n=49), NAC (1.2 gr)+ clomiphene citrate (100 mg) + letrozole (5mg) were prescribed daily from the third day of menstruation cycle for five days. The control group (n=48) had the same drug regimen without NAC. In order to follicular development, recombinant human follicle stimulating hormone (r-hFSH; Gonal-F®) was injected on days of 7-11 menstrual cycles in all participants. When the follicle size was 18mm or more, 10000 IU human chorionic gonadotropin was injected intramuscular and the intrauterine insemination was performed after 34-36 hr.
RESULTS


There were not significant differences between study groups regarding mean endometrial thickness (p=0.14), the mean number of mature follicles (p=0.20), and the pregnancy rate (p=0.09).
CONCLUSION


NAC is ineffective in inducing or augmenting ovulation in PCOS patients who were candidates for intrauterine insemination and cannot be recommended as an adjuvant to CC in such patients.",2017,"There were not significant differences between study groups regarding mean endometrial thickness (p=0.14), the mean number of mature follicles (p=0.20), and the pregnancy rate (p=0.09).
","['97 PCOS women aged 18-38 years', 'PCOS patients who were candidates for intrauterine insemination', 'patients with polycystic ovary syndrome (PCOS) without clomiphene citrate resistance']","['intrauterine insemination', 'recombinant human follicle stimulating hormone', 'NAC', 'N-acetyl cysteine', 'clomiphene citrate', 'N-acetyl cysteine (NAC', 'same drug regimen without NAC', '10000 IU human chorionic gonadotropin', 'NAC (1.2 gr)+ clomiphene citrate (100 mg) + letrozole']","['mean number of mature follicles', 'pregnancy rate', 'mean endometrial thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0016774', 'cui_str': 'Follicle Stimulating Hormone, Human'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4319546', 'cui_str': '10000'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",97.0,0.0908755,"There were not significant differences between study groups regarding mean endometrial thickness (p=0.14), the mean number of mature follicles (p=0.20), and the pregnancy rate (p=0.09).
","[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Behrouzi Lak', 'Affiliation': 'Department of Obstetrics and Gynecology, Urmia Reproductive Health Research Center, Urmia, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Hajshafiha', 'Affiliation': 'Department of Obstetrics and Gynecology, Urmia Reproductive Health Research Center, Urmia, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Nanbakhsh', 'Affiliation': 'Department of Obstetrics and Gynecology, Urmia Reproductive Health Research Center, Urmia, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Oshnouei', 'Affiliation': 'Department of Obstetrics and Gynecology, Urmia Reproductive Health Research Center, Urmia, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
808,28835940,"Pregnancy outcome of ""delayed start"" GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study.","BACKGROUND


Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART). Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards.
OBJECTIVE


The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF) outcomes.
MATERIALS AND METHODS


This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30), delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30) treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups.
RESULTS


Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups.
CONCLUSION


There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.",2017,"There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups.
","['sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF', 'poor responders']","['estrogen priming antagonist protocol', 'delayed start"" GnRH antagonist protocol versus GnRH antagonist protocol', 'delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment']","['rates of oocyte maturation, embryo formation, and IVF outcomes', 'endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy', 'Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles', 'Endometrial thickness']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Follicular Phase'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]",60.0,0.0895025,"There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups.
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Aflatoonian', 'Affiliation': 'Research and Clinical Center for Infertility, Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Aflatoonian', 'Initials': 'A', 'LastName': 'Hosseinisadat', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Baradaran', 'Affiliation': 'Research and Clinical Center for Infertility, Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farid Mojtahedi', 'Affiliation': ""Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Roointan Arash Women's Health Research and Educational Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
809,28810385,Is a general or specific exercise recommendation more effective for promoting physical activity among postpartum mothers?,"This comparative effectiveness trial examined the effects of a behavior change intervention supplemented by a general or specific exercise recommendation on physical activity among postpartum mothers. Participants ( N = 49) attended three workshop sessions that provided the exercise recommendation and taught self-regulatory skills. Physical activity, self-efficacy, planning, and barriers were assessed at baseline, post-intervention, and 6-month follow-up. Self-reported physical activity increased significantly in both groups ( p < .001), but the increase was larger in the general condition ( p = .03). Both groups reported increased planning and decreased barriers. Postpartum mothers may benefit from interventions that teach strategies for overcoming barriers while allowing them to choose preferred activities.",2019,"Self-reported physical activity increased significantly in both groups ( p < .001), but the increase was larger in the general condition ( p = .03).","['Postpartum mothers', 'Participants ( N\u2009=\u200949) attended three', 'postpartum mothers']","['behavior change intervention supplemented by a general or specific exercise recommendation', 'workshop sessions that provided the exercise recommendation and taught self-regulatory skills']","['Self-reported physical activity', 'physical activity', 'Physical activity, self-efficacy, planning, and barriers']","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0156241,"Self-reported physical activity increased significantly in both groups ( p < .001), but the increase was larger in the general condition ( p = .03).","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Mailey', 'Affiliation': 'Kansas State University, USA.'}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Hsu', 'Affiliation': 'Kansas State University, USA.'}]",Journal of health psychology,['10.1177/1359105316687627']
810,32412683,Costs and uptake of a community model of paediatric food allergy care versus specialist hospital care: A before-and-after controlled trial.,"AIM


To compare the costs of community-based food allergy model of care (intervention cohort, IC) with a tertiary-hospital, specialist allergy clinic model of care (control cohort, CC).
METHODS


In this pragmatic controlled trial, children (aged 0-12 years) newly referred to the allergy clinic at Melbourne's Royal Children's Hospital with suspected/known food allergy to three or fewer foods were allocated to see either a community-based paediatrician, trained via online webinars and web-based clinical decision support tools for food allergy diagnosis and management, or a hospital allergist. Per-patient costs to the health-care system and out-of-pocket costs to families seen within 12 months (clinician time, allergy tests and medicare billing) were compared between the two models of care.
RESULTS


At 12 months, 54/181 (30%) CC families had been seen in the allergy clinic and 93/115 (81%) of the IC families who chose to see a community paediatrician had been seen. In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81). Total out-of-pocket costs to family were $129 in the IC compared with $89 in the CC (mean difference $40, 95% CI $4-$77, P = 0.03).
CONCLUSIONS


A community-based model of care for simple food allergy showed that costs to the health-care system were similar between the community model and hospital care but did not show reduced out-of-pocket costs to the families 12-months post-enrolment.",2020,"In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81).","[""children (aged 0-12\u2009years) newly referred to the allergy clinic at Melbourne's Royal Children's Hospital with suspected/known food allergy to three or fewer foods"", 'paediatric food allergy care versus specialist hospital care']","['community-based paediatrician, trained via online webinars and web-based clinical decision support tools for food allergy diagnosis and management, or a hospital allergist', 'community-based food allergy model of care (intervention cohort, IC']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3810819', 'cui_str': 'Allergy clinic'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0334896', 'cui_str': 'Clinical immunologist'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],,0.0944563,"In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81).","[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Prescilla', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Mimi Lk', 'Initials': 'ML', 'LastName': 'Tang', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Danchin', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sung', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Karnon', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14905']
811,28331909,Evaluating the effect of insulin sensitizers metformin and pioglitazone alone and in combination on women with polycystic ovary syndrome: An RCT.,"BACKGROUND


Insulin resistance and hyperinsulinemia may play a role in pathogenesis of PCOS. One of the common therapeutic methods is using insulin-sensitizing drugs such as metformin and thiazolidinediones.
OBJECTIVE


The purpose was to determine the effect of metformin and pioglitazone on clinical, hormonal and metabolic parameters in women with PCOS.
MATERIALS AND METHODS


Eighty four women randomly received one of the following for 3 months: metformin (n=28) (500 mg three times a day), pioglitazone (30 mg daily) (n=28) and combination of both metformin and pioglitazone (n=28) (30 mg/day pioglitazone plus 500 mg metformin three times a day). Hormonal profile, fasting serum insulin, body weight, body mass index, menstrual status and waist to hip ratio were evaluated before and after treatment.
RESULTS


Metformin and pioglitazone and combination therapy induced favorable changes in fasting serum insulin, HOMA-IR index, QUICKI, fasting glucose to insulin ratio in women with PCOS. Body weight, BMI, and waist to hip ratio increased significantly after treatment with pioglitazone but the data were similar after administration of metformin or combination therapy. Total testosterone level decreased significantly only after treatment with metformin. After 3 months in patients who received pioglitazone or combination therapy, menstrual cycles became regular in 71.4% and 73.9% respectively. While menstrual improvement happened only in 36.4% of the patients treated with metformin.
CONCLUSION


These findings suggest that insulin-sensitizing drugs induce beneficial effect in insulin resistance and menstrual cyclicity but only metformin ameliorated hyperandrogenemia in women with PCOS. Treatment with combination of metformin and pioglitazone did not show more benefit than monotherapy with each drug alone.",2016,"Body weight, BMI, and waist to hip ratio increased significantly after treatment with pioglitazone but the data were similar after administration of metformin or combination therapy.","['women with PCOS', 'women with polycystic ovary syndrome', 'Eighty four women randomly received one of the following for 3 months']","['metformin', 'metformin and pioglitazone', 'insulin sensitizers metformin and pioglitazone', 'pioglitazone', 'pioglitazone or combination therapy', 'pioglitazone plus 500 mg metformin', 'Metformin and pioglitazone and combination therapy']","['Body weight, BMI, and waist to hip ratio', 'hyperandrogenemia', 'fasting serum insulin, HOMA-IR index, QUICKI, fasting glucose to insulin ratio', 'clinical, hormonal and metabolic parameters', 'Hormonal profile, fasting serum insulin, body weight, body mass index, menstrual status and waist to hip ratio', 'insulin resistance and menstrual cyclicity', 'Total testosterone level']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1635037', 'cui_str': 'Metformin / pioglitazone'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C1299574', 'cui_str': 'Hyperandrogenemia'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0031084', 'cui_str': 'Rhythmicity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",84.0,0.084325,"Body weight, BMI, and waist to hip ratio increased significantly after treatment with pioglitazone but the data were similar after administration of metformin or combination therapy.","[{'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Sohrevardi', 'Affiliation': 'Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Nosouhi', 'Affiliation': 'Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Hossein Khalilzade', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Parichehr', 'Initials': 'P', 'LastName': 'Kafaie', 'Affiliation': 'Department of Dermatology, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Karimi-Zarchi', 'Affiliation': 'Departments of Obstetrics and Gynecology, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.; Recurrent Abortion Research Center, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Halvaei', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mohsenzadeh', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran .'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
812,28249845,Efficacy of Prophylactic Dexmedetomidine in Preventing Postoperative Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery.,"BACKGROUND


Postoperative junctional ectopic tachycardia is one of the most serious arrhythmias that occur after pediatric cardiac surgery, difficult to treat and better to be prevented. Our aim was to assess the efficacy of prophylactic dexmedetomidine in preventing junctional ectopic tachycardia after pediatric cardiac surgery.
METHODS AND RESULTS


A prospective controlled study was carried out on 90 children who underwent elective cardiac surgery for congenital heart diseases. Patients were randomized into 2 groups. Group I (dexmedetomidine group): 60 patients received dexmedetomidine; Group II (Placebo group): 30 patients received the same amount of normal saline intravenously. The primary outcome was the incidence of postoperative junctional ectopic tachycardia. Secondary outcomes included bradycardia, hypotension, vasoactive inotropic score, ventilation time, pediatric cardiac care unit stay, length of hospital stay, and perioperative mortality. The incidence of junctional ectopic tachycardia was significantly reduced in the dexmedetomidine group (3.3%) compared with the placebo group (16.7%) with  P <0.005. Heart rate while coming off cardiopulmonary bypass was significantly lower in the dexmedetomidine group (130.6±9) than the placebo group (144±7.1) with  P <0.001. Mean ventilation time, and mean duration of intensive care unit and hospital stay (days) were significantly shorter in the dexmedetomidine group than the placebo group ( P <0.001). However, there was no significant difference between the 2 groups as regards mortality, bradycardia, or hypotension ( P >0.005).
CONCLUSION


Prophylactic use of dexmedetomidine is associated with significantly decreased incidence of postoperative junctional ectopic tachycardia in children after congenital heart surgery without significant side effects.",2017,"Mean ventilation time, and mean duration of intensive care unit and hospital stay (days) were significantly shorter in the dexmedetomidine group than the placebo group ( P <0.001).","['children after congenital heart surgery', '60 patients received', 'group', '90 children who underwent elective cardiac surgery for congenital heart diseases', 'group): 30 patients']","['normal saline intravenously', 'placebo', 'Placebo', 'Prophylactic Dexmedetomidine', 'dexmedetomidine', 'prophylactic dexmedetomidine']","['junctional ectopic tachycardia', 'postoperative junctional ectopic tachycardia', 'Postoperative Junctional Ectopic Tachycardia', 'regards mortality, bradycardia, or hypotension', 'Heart rate while coming off cardiopulmonary bypass', 'incidence of postoperative junctional ectopic tachycardia', 'bradycardia, hypotension, vasoactive inotropic score, ventilation time, pediatric cardiac care unit stay, length of hospital stay, and perioperative mortality', 'incidence of junctional ectopic tachycardia', 'Mean ventilation time, and mean duration of intensive care unit and hospital stay (days']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0039235', 'cui_str': 'Tachycardia, Ectopic Junctional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care treatments and procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",90.0,0.156418,"Mean ventilation time, and mean duration of intensive care unit and hospital stay (days) were significantly shorter in the dexmedetomidine group than the placebo group ( P <0.001).","[{'ForeName': 'Doaa Mohamed', 'Initials': 'DM', 'LastName': 'El Amrousy', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt doaamoha@yahoo.com.'}, {'ForeName': 'Nagat S', 'Initials': 'NS', 'LastName': 'Elshmaa', 'Affiliation': 'Department of Anesthesia & Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Kashlan', 'Affiliation': 'Department of Anesthesia & Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elsanosy', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Nahed', 'Initials': 'N', 'LastName': 'Hablas', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Shimaa', 'Initials': 'S', 'LastName': 'Elrifaey', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'El-Feky', 'Affiliation': 'Cardiothoracic Surgery Department, Tanta University Hospital, Tanta, Egypt.'}]",Journal of the American Heart Association,['10.1161/JAHA.116.004780']
813,27921090,The effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile patients: A randomized clinical trial.,"BACKGROUND


Implantation is one of the essential steps for the success of assisted reproductive techniques (ART). Their success depends on three main factors: embryo quality, endometrial receptivity (ER), and synchrony between embryo and endometrium. There are various factors that regulate the complex process of implantation. In this regard, one may refer to human chorionic gonadotropin (hCG) as the most important factor.
OBJECTIVE


This study aims to investigate the effect of intrauterine hCG injection before embryo transfer (ET) on pregnancy outcome in infertile couples.
MATERIALS AND METHODS


A total of 159 patients undergone In vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) with an antagonist protocol were evaluated. Patients were divided into three groups (n=53). Group 1 received 500 IU of hCG, group 2 received 1000 IU of hCG intrauterine injection before ET, and the control group underwent ET without hCG preceding intrauterine injection.
RESULTS


There was no significant difference among the groups. The implantation rates were 18.86%, 13.52%, and 14.37%, chemical pregnancy rates were 34%, 32.1%, and 35.3%, and clinical pregnancy rates were 34%, 32.1%, and 31.4% respectively.
CONCLUSION


The pregnancy outcome in IVF/ICSI /ET cycles cannot be improved through hCG intrauterine injections before ET.",2016,"The implantation rates were 18.86%, 13.52%, and 14.37%, chemical pregnancy rates were 34%, 32.1%, and 35.3%, and clinical pregnancy rates were 34%, 32.1%, and 31.4% respectively.
","['infertile couples', 'infertile patients', '159 patients undergone']","['human chorionic gonadotropin (hCG', 'vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI', 'intrauterine human chorionic gonadotropin injection before embryo transfer', 'hCG', 'hCG intrauterine injection before ET, and the control group underwent ET without hCG preceding intrauterine injection', 'intrauterine hCG injection before embryo transfer (ET']","['embryo quality, endometrial receptivity (ER), and synchrony between embryo and endometrium', 'implantation rates', 'chemical pregnancy rates', 'implantation and pregnancy rate', 'clinical pregnancy rates']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",159.0,0.314072,"The implantation rates were 18.86%, 13.52%, and 14.37%, chemical pregnancy rates were 34%, 32.1%, and 35.3%, and clinical pregnancy rates were 34%, 32.1%, and 31.4% respectively.
","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Dehghani Firouzabadi', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Janati', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Research and Clinical Center for Infertility, Dezful University of Medical Sciences, Dezful, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Razi', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
814,27921088,Intra uterine extra-amniotic versus vaginal misoprostol for termination of second trimester miscarriage: A randomized controlled trial.,"BACKGROUND


Termination of pregnancy in the second trimester using prostaglandins has been shown to be safe and effective. Misoprostol has multiple routes of administration; oral, vaginal, buccal, rectal and sublingual.
OBJECTIVE


The study aims to compare the efficacy and safety of intrauterine extra-amniotic and vaginal misoprostol in a dose of 200 microgram every 4 hours for the termination of pregnancy in cases of second trimester miscarriage.
MATERIALS AND METHODS


A prospective randomized open labeled clinical trial included 180 women with missed miscarriage in gestational age between 13 and 24 wks. Patients were randomized to receive subsequent doses of 200 µg misoprostol every 4 hrs either intra uterine extra-amniotic by Foley catheter or vaginally administered. Randomization was completed using a computer-generated random table. The primary outcome of this study was the mean duration from the initial misoprostol dose until complete fetal expulsion (induction-expulsion interval).
RESULTS


The mean gestational age was 17.74 wks. The mean time to complete miscarriage in the intra uterine extra-amniotic group was 5.27 hrs, which was significantly lower than the vaginal group (9.92 hrs, p=0.001). Side effects were more common in vaginal group.
CONCLUSION


Intra uterine extra-amniotic misoprostol with a dose of 200 µg every 4 hrs appears to be more effective and safer than vaginal misoprostol in induction of second trimester miscarriage.",2016,A prospective randomized open labeled clinical trial included 180 women with missed miscarriage in gestational age between 13 and 24 wks.,"['second trimester miscarriage', 'cases of second trimester miscarriage', '180 women with missed miscarriage in gestational age between 13 and 24 wks']","['intrauterine extra-amniotic and vaginal misoprostol', 'vaginal misoprostol', 'Intra uterine extra-amniotic versus vaginal misoprostol', 'Misoprostol', 'misoprostol every 4 hrs either intra uterine extra-amniotic by Foley catheter or vaginally administered']","['Side effects', 'mean time to complete miscarriage', 'mean duration from the initial misoprostol dose until complete fetal expulsion (induction-expulsion interval', 'efficacy and safety']","[{'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0000814', 'cui_str': 'Silent miscarriage'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0442084', 'cui_str': 'Extra-amniotic'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0179804'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1306041', 'cui_str': 'Complete miscarriage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",180.0,0.290678,A prospective randomized open labeled clinical trial included 180 women with missed miscarriage in gestational age between 13 and 24 wks.,"[{'ForeName': 'Abo Bakr', 'Initials': 'AB', 'LastName': 'Abbas Mitwaly', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine-Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine-Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Sayed', 'Initials': 'MS', 'LastName': 'Abdellah', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine-Assiut University, Assiut, Egypt.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
815,27981253,Efficacy of Intrauterine infusion of granulocyte colony stimulating factor on patients with history of implantation failure: A randomized control trial.,"BACKGROUND


Although pregnancy rate in in vitro fertilization-embryo transfer (IVF-ET) cycles has been increased over the preceding years, but the majority of IVF-ET cycles still fail. Granulocyte colony stimulating factor (GCSF) is a glycoprotein that stimulates cytokine growth factor and induces immune system which may improve pregnancy rate in women with history of implantation failure.
OBJECTIVE


The aim of this study was to evaluate GCSF ability to improve pregnancy rate in women with history of implantation failure.
MATERIALS AND METHODS


0.5 ml (300 µg/ml) GCSF was infused intrauterine in intervention group. Pregnancy outcomes were assessed based on clinical pregnancy.
RESULTS


The mean age of participants was 31.95±4.71 years old. There were no significant differences between demographic characteristics in two groups (p>0.05). The pregnancy outcome in GCSF group was improved significantly (p=0.043).
CONCLUSION


GCSF can improve pregnancy outcome in patients with history of implantation failure.",2016,"The pregnancy outcome in GCSF group was improved significantly (p=0.043).
","['women with history of implantation failure', '0.5', 'mean age of participants was 31.95±4.71 years old', 'patients with history of implantation failure']","['GCSF', 'Granulocyte colony stimulating factor (GCSF', 'Intrauterine infusion of granulocyte colony stimulating factor']","['pregnancy outcome', 'pregnancy rate', 'clinical pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",,0.145461,"The pregnancy outcome in GCSF group was improved significantly (p=0.043).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eftekhar', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Miraj', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.; Department of Obstetrics and Gynecology, School of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farid Mojtahedi', 'Affiliation': ""Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Roointan Arash Women's Health Research and Educational Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Nosrat', 'Initials': 'N', 'LastName': 'Neghab', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
816,32413431,Anchor vs suture for the attachment of vaginal mesh in a robotic-assisted sacrocolpopexy: a randomized clinical trial.,"BACKGROUND


Vaginal mesh attachment can be one of the most time-consuming components of a minimally invasive sacrocolpopexy.
OBJECTIVE


To assess the impact on the duration vaginal mesh attachment of using absorbable anchors compared to interrupted sutures for vaginal mesh attachment in robotic-assisted sacrocolpopexy.
STUDY DESIGN


This was a single-masked, randomized clinical trial of women with pelvic organ prolapse that underwent a robotic-assisted sacrocolpopexy at 2 clinical sites. The participants were randomized to receive either interrupted delayed absorbable anchors or sutures during the vaginal mesh attachment portion of the surgery. The participants completed validated questionnaires at baseline and at 6 weeks, 6 months, and 12 months after the surgery. A certified examiner, masked to the attachment technique that was used, performed a clinical examination using the Pelvic Organ Prolapse Quantification system and also assessed for mesh exposure and the overall appearance of the vaginal walls using a 10-cm visual analog scale at each follow-up visit. The primary outcome was the vaginal mesh attachment time. The categorical variables were compared using chi-square or Fischer's Exact test, whereas the continuous variables were compared using Student's t-test or Mann-Whitney U test where appropriate. An intention-to-treat analysis was performed.
RESULTS


Fifty-three participants were randomized, 26 to mesh attachment with anchor, 27 to mesh attachment with suture, and 81% (21/26) and 93% (25/27) had 12-month follow up respectively. There were no significant differences between the groups with regard to age (P=.12), body mass index (P=.23), stage of prolapse (P=.97), or other preoperative factors. Mesh attachment interval time was faster in the anchor compared to suturing study arm (12.2±7.8 vs 21.2±5.2 minutes; P<.001), while sacrocolpopexy times (107.6±33.2 vs 109.8±21.2 minutes; P=.774) were not different. The ease of placement for the surgeon based on a visual analog scale (P=.16), the appearance of the mesh attachment (P=.07), and the overall satisfaction with the use of the specific attachment type (P=.65) were similar for the arms. There was no difference in perioperative adverse events rates between arms and by 12 months follow-up there were no sacrocolpopexy mesh, anchor, or suture exposures. There was no difference in outcomes at 12 months including composite failure (10% vs 12%; P=.79), patient global impression of improvement (1.06 vs 1.19; P=.27), or patient pelvic pain (9.81 vs 9.67; P=.56).
CONCLUSION


In patients undergoing a robotic-assisted sacrocolpopexy, the anchor vaginal mesh attachment technique required significantly less time than suturing. There was no difference between techniques in complications, failure, surgeon, or patient-reported outcomes through 12 months of follow-up. Mesh attachment during sacrocolpopexy can be performed in less time by using the anchor technique, providing surgeons with an alternative surgical technique for this procedure.",2020,"There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up.","['patients undergoing', 'women with pelvic organ prolapse undergoing robotic-assisted sacrocolpopexy', 'Fifty-three participants']","['robotic-assisted sacrocolpopexy the anchor vaginal mesh attachment technique', 'VAS', 'Anchor versus Suture for Attachment of Vaginal Mesh in Robotic-Assisted Sacrocolpopexy', 'interrupted delayed-absorbable anchors or sutures', 'absorbable anchors compared to interrupted sutures']","['Mesh attachment interval time', 'patient global impression of improvement', 'patient pelvic pain', 'composite failure', 'vaginal mesh attachment time', 'BMI (p=0.23), stage of prolapse', 'perioperative adverse events rates', 'global satisfaction', 'appearance of mesh attachment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",53.0,0.29178,"There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Berger', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego Medical Center, San Diego, CA; Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Science, University of California San Diego, San Diego, CA. Electronic address: alexanderbergermd@gmail.com.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Tan-Kim', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego Medical Center, San Diego, CA.'}, {'ForeName': 'Shawn A', 'Initials': 'SA', 'LastName': 'Menefee', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego Medical Center, San Diego, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.018']
817,30616442,Sex Hormones in Women With Elevated Breast Cancer Risk Undergoing Weight Loss.,"Sedentary lifestyles and obesity are known risk factors for breast cancer. Elevated estrogen levels correlate with obesity and, independently, with increased breast cancer risk. Lifestyle interventions that reduce obesity may mitigate this risk, potentially via estrogen pathways. In a 6-month lifestyle intervention, overweight/obese women with high breast cancer risk were randomized to control ( n  = 7) or intervention ( n  = 6) and analyzed for sex hormone levels. Serum and urine hormones were evaluated by ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and sex hormone binding globulin (SHBG) by enzyme-linked immunosorbent assay (ELISA). Serum estrone (E1) and estradiol (E2) were reduced by 12.1% and 50.8%, respectively, at 9 months in the intervention group, which differed from controls ( p  = .043 and .020). This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p  = .035). These results suggest that a lifestyle intervention led to a favorable estrogen profile in relation to breast cancer risk.",2019,This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p = .035).,"['Women With Elevated Breast Cancer Risk Undergoing Weight Loss', 'overweight/obese women with high breast cancer risk']",[],"['Serum and urine hormones', 'Serum estrone (E1) and estradiol (E2', 'urine E1']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]",,0.015685,This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p = .035).,"[{'ForeName': 'Sophia A', 'Initials': 'SA', 'LastName': 'Stone', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Claire J', 'Initials': 'CJ', 'LastName': 'Han', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Taurence', 'Initials': 'T', 'LastName': 'Senn', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Dynamic Paths, Inc., Tacoma, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reding', 'Affiliation': 'Integrative Counseling Services, Seattle, WA, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Whittington', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kerryn W', 'Initials': 'KW', 'LastName': 'Reding', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}]",Western journal of nursing research,['10.1177/0193945918820672']
818,30426323,Age Moderates Link Between Training Effects and Treatment Response to Attention Bias Modification Treatment for Social Anxiety Disorder.,"Attention bias modification treatment (ABMT) aims to reduce anxiety symptoms via practice on computerized attention training tasks. Despite evidence of efficacy, clinical effects appear heterogeneous. More research on ABMT mechanisms and moderators of treatment response is needed. Age is one potentially important moderator, as developmental differences in training effects may impact response. We examined developmental links between ABMT training effects and response in social anxiety disorder (SAD). We pooled data from two randomized controlled trials in treatment-seeking youths and adults with SAD (N = 99) that used identical ABMT methods. We first characterized learning effects associated with the eight-session ABMT training protocol. We then tested whether learning magnitude predicted the clinical (change in SAD symptoms) and cognitive (change in attention bias) responses to treatment. Finally, we tested whether age moderated the association between ABMT learning and treatment response. Results indicate that ABMT was associated with an incremental learning curve during the protocol, and that learning improved with age. Age further moderated the association between learning gains during the ABMT protocol and subsequent reduction in self-reported SAD symptoms, such that this association was stronger with age. These effects were not evident in bias scores or clinician ratings. Finally, pre-treatment SAD symptoms and bias scores predicted ABMT learning gains. This study highlights the links among age, learning processes, and clinical response to ABMT. These insights may inform attempts to increase the clinical efficacy of ABMT for anxiety.",2019,"Age further moderated the association between learning gains during the ABMT protocol and subsequent reduction in self-reported SAD symptoms, such that this association was stronger with age.","['social anxiety disorder (SAD', 'treatment-seeking youths and adults with SAD (N\u2009=\u200999) that used identical ABMT methods', 'Social Anxiety Disorder']","['ABMT', 'Attention bias modification treatment (ABMT', 'Attention Bias Modification Treatment']",['incremental learning curve'],"[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0243176,"Age further moderated the association between learning gains during the ABMT protocol and subsequent reduction in self-reported SAD symptoms, such that this association was stronger with age.","[{'ForeName': 'Rany', 'Initials': 'R', 'LastName': 'Abend', 'Affiliation': 'Section on Development and Affective Neuroscience, National Institute of Mental Health, 9000 Rockville Pike, Bldg. 15K, Bethesda, MD, 20892, USA. rany.abend@nih.gov.'}, {'ForeName': 'Reut', 'Initials': 'R', 'LastName': 'Naim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Pergamin-Hight', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, 3404D Benjamin Building, College Park, MD, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Development and Affective Neuroscience, National Institute of Mental Health, 9000 Rockville Pike, Bldg. 15K, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}]",Journal of abnormal child psychology,['10.1007/s10802-018-0494-7']
819,32412419,A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial.,"BACKGROUND


Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity.
OBJECTIVE


The primary objective of this randomized controlled trial was to establish the feasibility of a mobile health (mHealth) physical activity exercise app for individuals with VLUs to improve lower leg function.
METHODS


In a 6-week study, adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3. Participants were randomized 1:1 to receive evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature. The mHealth Conditioning Activities for Lower Leg Function app also provided automated educational and motivational messages and user reports. Foot movement on the VLU-affected leg was tracked by a Bluetooth-enabled triaxial accelerometer. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the feasibility of reach, adherence, acceptability, implementation, and maintenance.
RESULTS


A total of 24 patients were recruited, enrolled, and randomized in the study. Most patients reported difficulty following the protocol for exercising and using the accelerometer and mobile phone and did not use the provider contact feature. However, all patients were adherent to the 6-week exercise program more than 85% of the time for duration, whereas 33% (8/24) of patients adhered more than 85% for the frequency of performing the exercises. Across the three exercise levels, adherence did not differ between the two groups. Confidence limits around the difference in proportions ranged from -0.4 to 0.7. Providers in FOOTFIT+ were inconsistent in checking participant progress reports because of lack of time from competing work commitments. The technology became outdated quickly, making maintenance problematic. Participants said they would continue to exercise their foot and legs and liked being able to follow along with the demonstrations of each level of exercise provided through the app.
CONCLUSIONS


The findings of this study suggest that despite initial interest in using the app, several components of the program as originally designed had limited acceptability and feasibility. Future refinements should include the use of more modern technology including smaller wearable accelerometers, mobile phones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features.
TRIAL REGISTRATION


ClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695.",2020,"Across the three exercise levels, adherence did not differ between the two groups.","['Individuals With Chronic Venous Leg Ulcers', 'Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions', 'adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3', 'individuals with VLUs', 'A total of 24 patients']","['evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature', 'Leg Physical Activity Intervention', 'mobile health (mHealth) physical activity exercise']","['feasibility of reach, adherence, acceptability, implementation, and maintenance', 'Confidence limits']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",24.0,0.0958684,"Across the three exercise levels, adherence did not differ between the two groups.","[{'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kelechi', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Prentice', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Madisetti', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Vertegel', 'Affiliation': 'Department of Bioengineering, Clemson University, Clemson, SC, United States.'}]",JMIR mHealth and uHealth,['10.2196/15015']
820,28522181,"Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.","BACKGROUND


In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo. Post-hoc analysis of these data revealed that patients in an early stage with definite or probable diagnosis of ALS, defined by the revised El Escorial criteria, who met a select set of inclusion criteria showed a greater magnitude of effect than did the full study population. We aimed to substantiate this post-hoc result and assess safety and efficacy of edaravone in a phase 3 trial that focused on patients with early stage ALS who met the post-hoc analysis inclusion criteria.
METHODS


In this phase 3, randomised, double-blind, parallel-group study, patients aged 20-75 years with ALS of grade 1 or 2 in the Japan ALS Severity Classification, scores of at least 2 points on all 12 items of ALSFRS-R, forced vital capacity of 80% or more, definite or probable ALS according to the revised El Escorial criteria, and disease duration of 2 years or less were recruited from 31 hospitals in Japan. Eligible patients also had a decrease of 1-4 points in the ALSFRS-R score during a 12-week observation period before randomisation. Patients meeting all criteria were then randomly assigned 1:1 to receive 60 mg intravenous edaravone or intravenous saline placebo for 6 cycles (4 weeks per cycle with 2 weeks on, 2 weeks off) for a total treatment duration of 24 weeks. In cycle 1, the study drug or placebo was administered once per day for 14 days within a 14 day period, followed by the drug-free period. In cycle 2 and thereafter, the study drug or placebo was administered for 10 days within a 14 day period, followed by a 2 week drug-free period. Participants and investigators, including those assessing outcomes, were masked to treatment allocation. The primary efficacy outcome was the change in ALSFRS-R score from the baseline to 24 weeks (or at discontinuation if this was after the third cycle) after randomisation. The primary outcome was assessed in all patients who had received at least one treatment infusion, had at least one assessment post-baseline, and reached the end of cycle 3. For patients with missing values at the end of cycle 6, data were imputed by the last observation carried forward (LOCF) method, provided the patients had completed at least cycle 3. Safety was assessed in all patients who had received at least one treatment infusion and had at least one assessment post-baseline. This trial is registered with ClinicalTrials.gov, NCT01492686.
FINDINGS


Between Nov 28, 2011, and Sept 3, 2014, we screened 213 patients, and enrolled 192 as potential participants. Of these, 137 patients completed the observation period: 69 were randomly assigned to receive edaravone, and 68 were randomly assigned to receive placebo. 68 patients taking edaravone and 66 taking placebo were included in the primary efficacy analysis. For the primary outcome, the change in ALSFRS-R score was -5·01 (SE 0·64) in the edavarone group and -7·50 (0·66) in the placebo group. The least-squares mean difference between groups was 2·49 (SE 0·76, 95% CI 0·99-3·98; p=0·0013) in favour of edaravone. Treatment-emergent adverse events were reported in 58 (84%) patients receiving edaravone and 57 (84%) patients receiving placebo. 11 (16%) patients taking edaravone and 16 (24%) taking placebo had serious adverse events, and one (1%) patient receiving edaravone and four (6%) patients receiving placebo had adverse events (one dysphagia in edaravone group and one dyspnoea, two respiratory disorder, and one rash in the placebo group) that led to withdrawal.
INTERPRETATION


Edaravone showed efficacy in a small subset of people with ALS who met criteria identified in post-hoc analysis of a previous phase 3 study, showing a significantly smaller decline of ALSFRS-R score compared with placebo. There is no indication that edaravone might be effective in a wider population of patients with ALS who do not meet the criteria.
FUNDING


Mitsubishi Tanabe Pharma Corporation.",2017,"The primary outcome was assessed in all patients who had received at least one treatment infusion, had at least one assessment post-baseline, and reached the end of cycle 3.","['68 patients taking edaravone and 66 taking', 'Patients meeting all criteria', '137 patients completed the observation period: 69', 'patients who had received at least one treatment infusion and had at least one assessment post-baseline', 'patients with amyotrophic lateral sclerosis', 'patients aged 20-75 years with ALS of grade 1 or 2 in the Japan ALS Severity Classification, scores of at least 2 points on all 12 items of ALSFRS-R, forced vital capacity of 80% or more, definite or probable ALS according to the revised El Escorial criteria, and disease duration of 2 years or less were recruited from 31 hospitals in Japan', 'Between Nov 28, 2011, and Sept 3, 2014, we screened 213 patients, and enrolled 192 as potential participants', 'patients with early stage ALS who met the post-hoc analysis inclusion criteria', 'patients with amyotrophic lateral sclerosis (ALS']","['edaravone or intravenous saline placebo', 'placebo', 'edaravone']","['Revised ALS Functional Rating Scale (ALSFRS-R) score', 'adverse events', 'change in ALSFRS-R score', 'ALSFRS-R score', 'Safety and efficacy', 'serious adverse events', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.645702,"The primary outcome was assessed in all patients who had received at least one treatment infusion, had at least one assessment post-baseline, and reached the end of cycle 3.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(17)30115-1']
821,31578169,"Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial.","BACKGROUND


At present, no approved pharmacotherapies are available for unclassifiable interstitial lung disease (ILD), which is characterised by progressive fibrosis of the lung. We aimed to assess the efficacy and safety of pirfenidone in patients with progressive fibrosing unclassifiable ILD.
METHODS


We did a multicentre, double-blind, randomised, placebo-controlled phase 2 trial at 70 centres in Australia, Belgium, Canada, Czech Republic, Denmark, Germany, Greece, Ireland, Israel, Italy, Poland, Portugal, Spain, and the UK. Eligible patients (aged ≥18-85 years) had progressive fibrosing unclassifiable ILD, a percent predicted forced vital capacity (FVC) of 45% or higher and percent predicted carbon monoxide diffusing capacity (DLco) of 30% or higher, more than 10% fibrosis on high-resolution CT, and a high-resolution CT from the previous 12 months. Patients were randomly assigned (1:1) to 2403 mg oral pirfenidone daily or placebo using a central validated interactive voice or web-based response system, stratified by concomitant mycophenolate mofetil use and presence or absence of interstitial pneumonia with autoimmune features. Investigators, site personnel, and patients were masked to treatment assignment. The primary endpoint was mean predicted change in FVC from baseline over 24 weeks, measured by daily home spirometry. Secondary endpoints were change in FVC measured by site spirometry, proportion of patients who had a more than 5% or more than 10% absolute or relative decline in percent predicted FVC measured by clinic-based spirometry, change in percent predicted DLco, change in 6-min walk distance (6MWD), change in University of California San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) score, change in Leicester Cough Questionnaire score, change in cough visual analogue scale, and changes in total and subscores of the St George's Respiratory Questionnaire (SGRQ), all of which were compared with baseline. Additional secondary endpoints included proportion of patients who had non-elective hospitalisation (respiratory and all-cause) and acute exacerbations, and progression-free survival. Efficacy was analysed in the intention-to-treat (ITT) population, which included all randomly assigned patients. Safety was assessed in the safety analysis set, which included all randomly assigned patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT03099187, and is no longer recruiting.
FINDINGS


Between May 15, 2017, and June 5, 2018, 253 patients were randomly assigned to receive 2403 mg pirfenidone (n=127) or placebo (n=126) and were included in the ITT analysis set. Analysis of the primary endpoint was affected by intraindividual variability in home spirometry values, which prevented application of the prespecified statistical model. Over 24 weeks, predicted median change in FVC measured by home spirometry was -87·7 mL (Q1-Q3 -338·1 to 148·6) in the pirfenidone group versus -157·1 mL (-370·9 to 70·1) in the placebo group. Over 24 weeks, predicted mean change in FVC measured by site spirometry was lower in patients given pirfenidone than placebo (treatment difference 95·3 mL [95% CI 35·9 to 154·6], p=0·002). Compared with the placebo group, patients in the pirfenidone group were less likely to have a decline in FVC of more than 5% (odds ratio [OR] 0·42 [95% CI 0·25 to 0·69], p=0·001) or more than 10% (OR 0·44 [0·23 to 0·84], p=0·011). At week 24, mean change in DLco from baseline was -0·7% (SD 7·1) for the pirfenidone group and -2·5% (8·8) for the placebo group, and mean change in 6MWD from baseline was -2·0 m (68·1) for the pirfenidone group and -26·7 m (79·3) for the placebo group. Changes from baseline in UCSD-SOBQ, Leicester Cough Questionnaire score, cough visual analogue scale, and SGRQ scores were similar between the pirfenidone and placebo groups at week 24. Analysis of acute exacerbations, hospital admissions, and time to death from respiratory causes during the study yielded no meaningful results due to a small number of events. No differences in progression-free survival were identified between the pirfenidone and placebo groups, irrespective of the definition of progression-free survival used. Treatment-emergent adverse events were reported in 120 (94%) of 127 patients in the pirfenidone group and 101 (81%) of 124 patients in the placebo group. Serious treatment-emergent adverse events were reported in 18 (14%) patients in the pirfenidone group and 20 (16%) patients in the placebo group. The most common treatment-related treatment-emergent adverse events were gastrointestinal disorders (60 [47%] in the pirfenidone group vs 32 [26%] in the placebo group), fatigue (16 [13%] vs 12 [10%]), and rash (13 [10%] vs nine [7%]).
INTERPRETATION


Although the planned statistical model could not be applied to the primary endpoint data, analysis of key secondary endpoints suggests that patients with progressive fibrosing unclassifiable ILD could benefit from pirfenidone treatment, which has an acceptable safety and tolerability profile. These findings support further investigation of pirfenidone as an effective treatment for patients with progressive fibrotic unclassifiable ILD.
FUNDING


F Hoffmann-La Roche.",2020,"Over 24 weeks, predicted mean change in FVC measured by site spirometry was lower in patients given pirfenidone than placebo (treatment difference","['70 centres in Australia, Belgium, Canada, Czech Republic, Denmark, Germany, Greece, Ireland, Israel, Italy, Poland, Portugal, Spain, and the UK', 'patients with progressive fibrotic unclassifiable ILD', 'Between May 15, 2017, and June 5, 2018, 253 patients', 'patients with unclassifiable progressive fibrosing interstitial lung disease', 'patients with progressive fibrosing unclassifiable ILD', 'Eligible patients (aged ≥18-85 years) had progressive fibrosing unclassifiable ILD, a percent predicted forced vital capacity (FVC) of 45% or higher and percent predicted carbon monoxide diffusing capacity (DLco) of 30% or higher, more than 10% fibrosis on high-resolution CT, and a high-resolution CT from the previous 12 months', '95·3']","['pirfenidone', 'pirfenidone daily or placebo using a central validated interactive voice or web-based response system, stratified by concomitant mycophenolate mofetil', 'placebo', 'mL', 'Pirfenidone']","['mean change in FVC measured by site spirometry', 'FVC', 'Safety', 'UCSD-SOBQ, Leicester Cough Questionnaire score, cough visual analogue scale, and SGRQ scores', 'progression-free survival', 'efficacy and safety', 'mean predicted change in FVC', ""6-min walk distance (6MWD), change in University of California San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) score, change in Leicester Cough Questionnaire score, change in cough visual analogue scale, and changes in total and subscores of the St George's Respiratory Questionnaire (SGRQ"", 'Efficacy', 'median change in FVC', 'rash', 'mean change in DLco', 'Serious treatment-emergent adverse events', 'change in FVC', 'proportion of patients who had non-elective hospitalisation (respiratory and all-cause) and acute exacerbations, and progression-free survival', 'mean change in 6MWD', 'fatigue', 'intraindividual variability in home spirometry values']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0199525', 'cui_str': 'Carbon monoxide diffusing capacity measurement (procedure)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0745036', 'cui_str': 'Elective hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",253.0,0.690512,"Over 24 weeks, predicted mean change in FVC measured by site spirometry was lower in patients given pirfenidone than placebo (treatment difference","[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'Inflammation, Repair, and Development Section, National Heart and Lung Institute, Imperial College London, London, UK; National Institute for Health Research Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK. Electronic address: t.maher@rbht.nhs.uk.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia; Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Aryeh', 'Initials': 'A', 'LastName': 'Fischer', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO, USA; Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Department of Pulmonology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Divison of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Medical Center, New York, NY, USA; Regeneron Pharmaceuticals, New York, NY, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Molina-Molina', 'Affiliation': 'Respiratory Department, Unit of Interstitial Lung Diseases, University Hospital of Bellvitge Institute for Biomedical Research (IDIBELL), Barcelona, Spain; Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Axmann', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Klaus-Uwe', 'Initials': 'KU', 'LastName': 'Kirchgaessler', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Samara', 'Affiliation': 'F Hoffmann-La Roche, Athens, Greece.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gilberg', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Coordinating Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Lyon, France; Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30341-8']
822,31570942,Modification of Blood Test Draw Order to Reduce Blood Culture Contamination: A Randomized Clinical Trial.,"BACKGROUND


Blood culture contamination leads to unnecessary interventions and costs. It may be caused by bacteria in deep skin structures unsusceptible to surface decontamination. This study was designed to test whether diversion of blood obtained at venipuncture into a lithium heparin tube prior to aspiration of blood culture reduces contamination.
METHODS


The order of blood draws for biochemistry and blood cultures was randomized. Following standard disinfection and venipuncture, blood was either aspirated into a sterile lithium heparin tube before blood culture bottles (diversion group) or blood cultures first and then lithium heparin tube (control group). All study personnel were blinded with the exception of the phlebotomist.
RESULTS


After exclusions, 970 blood culture/biochemistry sets were analyzed. Contamination occurred in 24 of 480 (5.0%) control vs 10 of 490 (2.0%) diversion group cultures (P = .01). True pathogens were identified in 26 of 480 (5.4%) control vs 18 of 490 (3.7%) diversion cultures (P = .22). Despite randomization, demographic differences were apparent between the 2 groups. A post hoc analysis of 637 cultures from 610 medical patients admitted from home neutralized demographic differences. Culture contamination remained more frequent in the control vs diversion group (17/312 [5%] vs 7/325 [2%]; P = .03). Fewer diversion group patients were admitted to hospital (control: 200/299 [66.9%] vs diversion: 182/311 [58.5%]; P = .03), and length of stay was shorter (control: 30 hours [interquartile range {IQR}, 6-122] vs diversion: 22 [IQR, 5-97]; P = .02).
CONCLUSIONS


Use of lithium heparin tubes for diversion prior to obtaining blood cultures led to a 60% decrease in contamination. This technique is easy and inexpensive and might decrease overall hospital length of stay.
CLINICAL TRIALS REGISTRATION


NCT03966534.",2020,"Culture contamination remained more frequent in the control versus diversion group (17/312, 5% versus 7/325, 2%, p=0.03).",['610 medical patients admitted from home neutralized demographic differences'],"['standard disinfection and venipuncture, blood was either aspirated into a sterile lithium-heparin tube before blood culture bottles (diversion group) or blood cultures first and then lithium-heparin tube (control group', 'lithium-heparin']","['length of stay', 'Contamination', 'blood culture contamination', 'overall hospital length of stay', 'Culture contamination']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220814', 'cui_str': 'culture'}]",970.0,0.038686,"Culture contamination remained more frequent in the control versus diversion group (17/312, 5% versus 7/325, 2%, p=0.03).","[{'ForeName': 'Frederic S', 'Initials': 'FS', 'LastName': 'Zimmerman', 'Affiliation': 'Critical Care Unit, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Karameh', 'Affiliation': 'Department of Geriatrics, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Ben-Chetrit', 'Affiliation': 'Infectious Disease Unit, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Zalut', 'Affiliation': 'Department of Emergency Medicine, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Assous', 'Affiliation': 'Laboratory of Clinical Microbiology and Immunology, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levin', 'Affiliation': 'Critical Care Unit, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz971']
823,29762717,Durable complete responses in some recurrent high-grade glioma patients treated with Toca 511 + Toca FC.,"Background


Vocimagene amiretrorepvec (Toca 511) is an investigational gamma-retroviral replicating vector encoding cytosine deaminase that, when used in combination with extended-release 5-fluorocytosine (Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity. Recurrent high-grade glioma (rHGG) patients have a high unmet need for effective therapies that produce durable responses lasting more than 6 months. In this setting, relapse is nearly universal and most responses are transient.
Methods


In this Toca 511 ascending-dose phase I trial (NCT01470794), HGG patients who recurred after standard of care underwent surgical resection and received Toca 511 injected into the resection cavity wall, followed by orally administered cycles of Toca FC.
Results


Among 56 patients, durable complete responses were observed. A subgroup was identified based on Toca 511 dose and entry requirements for the follow-up phase III study. In this subgroup, which included both isocitrate dehydrogenase 1 (IDH1) mutant and wild-type tumors, the durable response rate is 21.7%. Median duration of follow-up for responders is 35.7+ months. As of August 25, 2017, all responders remain in response and are alive 33.9+ to 52.2+ months after Toca 511 administration, suggesting a positive association of durable response with overall survival.
Conclusions


Multiyear durable responses have been observed in rHGG patients treated with Toca 511 + Toca FC in a phase I trial, and the treatment will be further evaluated in a randomized phase III trial. Among IDH1 mutant patients treated at first recurrence, there may be an enrichment of complete responders.",2018,"(Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity.","['patients who recurred after standard of care underwent', '56 patients', 'Recurrent high-grade glioma (rHGG) patients']","['surgical resection and received Toca 511 injected into the resection cavity wall, followed by orally administered cycles of Toca FC', '5-fluorocytosine', 'HGG']","['durable response rate', 'Median duration', 'local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0016278', 'cui_str': 'Flucytosine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0887899', 'cui_str': 'Myeloid Cells'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]",,0.0285941,"(Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity.","[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Landolfi', 'Affiliation': 'New Jersey Neuroscience Institute, JFK Brain Tumor Center, Edison, New Jersey.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Ostertag', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Elder', 'Affiliation': 'Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bloomfield', 'Affiliation': 'New Jersey Neuroscience Institute, JFK Brain Tumor Center, Edison, New Jersey.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'Clark C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Kalkanis', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kesari', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lai', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'Ian Y', 'Initials': 'IY', 'LastName': 'Lee', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Liau', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Mikkelsen', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Phioanh', 'Initials': 'P', 'LastName': 'Nghiemphu', 'Affiliation': 'Departments of Neuro-Oncology and Neurosurgery, University of California, Los Angeles, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piccioni', 'Affiliation': 'Moores Cancer Center, Department of Neurosciences, University of California, San Diego, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Accomando', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Oscar R', 'Initials': 'OR', 'LastName': 'Diago', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hogan', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Gammon', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Kasahara', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Thian', 'Initials': 'T', 'LastName': 'Kheoh', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Jolly', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Harry E', 'Initials': 'HE', 'LastName': 'Gruber', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Tocagen Inc., San Diego, California.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}]",Neuro-oncology,['10.1093/neuonc/noy075']
824,29338124,Conservative therapy for chalazia: is it really effective?,"PURPOSE


To assess the within-treatment efficacy of hot compresses (HC), HC plus tobramycin (Tobrex) and HC plus tobramycin/dexamethasone (Tobradex) for chalazia treatment.
METHODS


Design: Multicentre, randomized clinical trial (ClinicalTrials.gov identifier, NCT01230593).
SETTING


Two clinical sites in New York and two clinical sites in Ontario.
STUDY POPULATION


A total of 149 patients with one or more chalazia on separate eyelids randomly assigned to receive HC (n = 50), HC plus tobramycin (n = 50) or HC plus tobramycin/dexamethasone (n = 49).
INTERVENTION


4-6 weeks of assigned treatment. Patients were measured for chalazion horizontal width and surveyed for pain and treatment satisfaction levels.
MAIN OUTCOME MEASURES


Primary outcome was complete resolution (100% size reduction). Secondary outcomes were size change in millimetres and patient reported pre- and post-treatment pain and satisfaction levels.
RESULTS


In the intention-to-treat (ITT) population, complete resolution occurred in 36 (18%) lesions total, 13 (21%) treated with HC, 12 (16%) with HC plus tobramycin and 11 (18%) with HC plus tobramycin/dexamethasone, with no significant difference between them (p = .78). Individually by paired t-test, there were statistically significant post-treatment mean size differences: HC 1.20 mm (p < 0.001), HC plus tobramycin 1.69 mm (p < .001) and HC plus tobramycin/dexamethasone 1.54 mm (p < 0.001), but no significant difference between them (p = .61). Lesions that completely resolved had a statistically significant lower pretreatment duration (1.5 months) compared to lesions that did not completely resolve (2.2 months) (p = .04).
CONCLUSION


Hot compresses (HC) alone or in combination with tobramycin or tobramycin/dexamethasone drops and ointment are all effective first-line treatment options for chalazia. However, physicians may consider moving directly to the use of more invasive therapies, such as incision and curettage or steroid injections, for chalazia that have been present for more than 2 months, as older lesions are less likely to resolve with conservative therapies alone.",2018,"Individually by paired t-test, there were statistically significant post-treatment mean size differences: HC 1.20 mm (p < 0.001), HC plus tobramycin 1.69 mm (p < .001) and HC plus tobramycin/dexamethasone 1.54 mm (p < 0.001), but no significant difference between them (p = .61).","['149 patients with one or more chalazia on separate eyelids randomly assigned to receive', 'Two clinical sites in New York and two clinical sites in Ontario', 'chalazia']","['HC plus tobramycin/dexamethasone', 'HC', 'HC plus tobramycin', 'Conservative therapy', 'hot compresses (HC), HC plus tobramycin (Tobrex) and HC plus tobramycin/dexamethasone', 'Hot compresses (HC) alone or in combination with tobramycin or tobramycin/dexamethasone', 'tobramycin/dexamethasone']","['size change in millimetres and patient reported pre- and post-treatment pain and satisfaction levels', 'complete resolution', 'chalazion horizontal width and surveyed for pain and treatment satisfaction levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007933', 'cui_str': 'Meibomian Cyst'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439200', 'cui_str': 'mm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1291732', 'cui_str': 'Treatment pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0007933', 'cui_str': 'Meibomian Cyst'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",149.0,0.0784342,"Individually by paired t-test, there were statistically significant post-treatment mean size differences: HC 1.20 mm (p < 0.001), HC plus tobramycin 1.69 mm (p < .001) and HC plus tobramycin/dexamethasone 1.54 mm (p < 0.001), but no significant difference between them (p = .61).","[{'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Kalla A', 'Initials': 'KA', 'LastName': 'Gervasio', 'Affiliation': 'Department of Ophthalmology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Kellie N', 'Initials': 'KN', 'LastName': 'Gergoudis', 'Affiliation': 'Department of Ophthalmology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Ophthalmology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Oestreicher', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Harvey', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}]",Acta ophthalmologica,['10.1111/aos.13675']
825,31541851,A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia.,"BACKGROUND


Internet-based cognitive behavioral treatment (iCBT-I) for insomnia comprising different sleep-related cognitive and behavioral interventional components has shown some promise. However, it is not known which components are necessary for a good treatment outcome.
METHOD


People suffering from insomnia (N = 104) without any other comorbid psychiatric disorders were randomized (2:2:1) to two guided internet-based self-help interventions for insomnia [multi-component cognitive behavioral self-help intervention (MCT); sleep restriction intervention for insomnia (SRT)], and care as usual [CAU]. In all three conditions, additional care or treatment was allowed. The primary outcome was insomnia severity measured with the insomnia severity index (ISI) at eight weeks. Furthermore, the two active conditions were compared regarding sleep efficacy from daily diary data over the eight weeks, and other measures from the daily protocols. Secondary outcomes included sleep quality, depressive symptoms, dysfunctional beliefs, and quality of life at post-treatment (eight weeks) and follow-up (six months after randomization).
RESULTS


Both conditions were more effective than CAU at post-treatment, with medium to large between-group effect sizes on the primary outcome (ISI; MCT: Cohen's d = -1.15; SRT: d = -0.68) and small to medium between-group effect sizes for secondary outcomes. Treatment gains were maintained at six-month follow-up. Active conditions did not differ from each other on all measures from pre to post, except for dysfunctional beliefs about sleep, and sleep protocol data throughout the intervention. Participants in MCT were significantly more satisfied with the intervention than participants in SRT.
CONCLUSIONS


Results of the present study indicate that CAU + MCT and CAU + SRT are both effective compared to CAU. There were no statistical differences regarding efficacy between the two active conditions, but participants in MCT reported to be more satisfied with the intervention.",2019,"Active conditions did not differ from each other on all measures from pre to post, except for dysfunctional beliefs about sleep, and sleep protocol data throughout the intervention.",['People suffering from insomnia (N\xa0=\xa0104) without any other comorbid psychiatric disorders'],"['guided internet-based self-help interventions for insomnia [multi-component cognitive behavioral self-help intervention (MCT); sleep restriction intervention for insomnia (SRT)], and care as usual [CAU', 'guided internet-based multi-component treatment and internet-based guided sleep restriction treatment', 'Internet-based cognitive behavioral treatment (iCBT-I']","['insomnia severity measured with the insomnia severity index (ISI', 'sleep quality, depressive symptoms, dysfunctional beliefs, and quality of life', 'sleep efficacy']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034380'}]",,0.0869151,"Active conditions did not differ from each other on all measures from pre to post, except for dysfunctional beliefs about sleep, and sleep protocol data throughout the intervention.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Institute for Psychology, University of Bern, Bern, Switzerland. Electronic address: tobias.krieger@psy.unibe.ch.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Urech', 'Affiliation': 'Institute for Psychology, University of Bern, Bern, Switzerland; Neurorehabilitation Dept. of Neurology, Hospital and University of Bern, Riggisberg, Switzerland.'}, {'ForeName': 'Simone B', 'Initials': 'SB', 'LastName': 'Duss', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University Bern, Bern, Switzerland.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Blättler', 'Affiliation': 'Institute for Psychology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schmitt', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University Bern, Bern, Switzerland; University Hospital of Psychiatry and Psychotherapy Bern, Switzerland.'}, {'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Gast', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University Bern, Bern, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bassetti', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Institute for Psychology, University of Bern, Bern, Switzerland.'}]",Sleep medicine,['10.1016/j.sleep.2019.01.045']
826,28462399,Can letrozole plus HMG protocol improve pregnancy outcomes in frozen-thawed embryo transfer? An RCT.,"BACKGROUND


There are different methods in endometrial preparation for frozen-thawed embryo transfer (FET).
OBJECTIVE


The purpose of this study was to compare the live birth rate in the artificial FET protocol (estradiol/ progesterone with GnRH-agonist) with stimulated cycle FET protocol (letrozole plus HMG).
MATERIALS AND METHODS


This randomized clinical trial included 100 women (18-42 years) randomly assigned to two groups based on Bernoulli distribution. Group I received GnRH agonist [Bucerelin, 500μg subcutaneously] from the previous midlutea lcycle, Then estradiol valerat [2 mg/ daily orally] was started on the second day and was increased until the observation of 8mm endometrial thickness. Finally progesterone [Cyclogest, 800 mg, vaginally] was started. Group II received letrozole on the second day of the cycle for five days, then HMG 75 IU was injected on the7 th  day. After observing [18 mm folliclhCG10000 IU was injected for ovulation induction. Trans cervical embryo transfer was performed in two groups. The main outcome was the live birth rate. The rate of live birth, implantation, chemical, and clinical pregnancy, abortion, cancellation and endometrial thickness were compared between two groups.
RESULTS


Implantation rate was significantly higher in group I. Live birth rate was slightly increased in group I without significant difference (30% vs. 26%). The rate of chemical and clinical pregnancy was similar in two groups. The abortion rate was lower in letrozole protocol but the difference was not statistically significant. The mean endometrial thickness was not different between two groups.
CONCLUSION


Letrozole plus HMG method cannot improve pregnancy outcomes in frozen-thawed embryo transfer but it has only one injection compare to daily injections in artificial method.",2017,"RESULTS


Implantation rate was significantly higher in group I. Live birth rate was slightly increased in group",['100 women (18-42 years'],"['progesterone', 'GnRH agonist [Bucerelin, 500μg subcutaneously', 'Letrozole plus HMG', 'letrozole plus HMG protocol', 'artificial FET protocol (estradiol/ progesterone with GnRH-agonist) with stimulated cycle FET protocol (letrozole plus HMG', 'letrozole']","['rate of live birth, implantation, chemical, and clinical pregnancy, abortion, cancellation and endometrial thickness', 'live birth rate', 'mean endometrial thickness', 'rate of chemical and clinical pregnancy', 'abortion rate', 'Live birth rate', 'Implantation rate', 'pregnancy outcomes']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0643582', 'cui_str': 'FETS'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}]",100.0,0.0874576,"RESULTS


Implantation rate was significantly higher in group I. Live birth rate was slightly increased in group","[{'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aleyasin', 'Affiliation': 'Department of Obstetrics and Gynecology, Infertility Unit, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Aghahosseini', 'Affiliation': 'Department of Obstetrics and Gynecology, Infertility Unit, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Safdarian', 'Affiliation': 'Department of Obstetrics and Gynecology, Infertility Unit, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Noorzadeh', 'Affiliation': 'Department of Obstetrics and Gynecology, Infertility Unit, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Fallahi', 'Affiliation': 'Fertility and Infertility Center, Shariati Hospital, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezaeian', 'Affiliation': 'Fertility and Infertility Center, Shariati Hospital, Tehran, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Hoseinimosa', 'Affiliation': 'Department of Obstetrics and Gynecology, Infertility Unit, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
827,28462402,Letrozole+ GnRH antagonist stimulation protocol in poor ovarian responders undergoing intracytoplasmic sperm injection cycles: An RCT.,"BACKGROUND


Gonadotropin-releasing hormone (GnRH) antagonist protocol has been proposed as a potentially proper option for the patients with limited ovarian reserve. Nevertheless, there is no significant difference in terms of clinical pregnancy between the GnRH antagonist and agonist cycles. The use of aromatase inhibitors such as letrozole was suggested by some studies.
OBJECTIVE


The object of this study was to evaluate the efficacy of letrozole co-treatment with GnRH-antagonist protocol in ovarian stimulation of poor responder patients undergoing intracytoplasmic sperm injection.
MATERIALS AND METHODS


A double-blinded randomized control trial was conducted on 70 infertile women with poor ovarian response based on Bologna criteria in two groups: letrozole+GnRH-antagonist (LA) group and placebo+GnRH-antagonist (PA) group (n=35/each). The LA group involved at letrozole 2.5 mg daily over 5 days and recombinant human follicle stimulating hormone 225 IU/daily. The PA group received placebo over 5 days and recombinant human follicle stimulating hormone at the same starting day and dose, similar to LA group. GnRH-antagonist was introduced once one or more follicle reached ≥14 mm. The main outcome measures were the number of oocytes retrieved, fertilization rate, implantation rate, cycle cancellation rate, and clinical pregnancy rate.
RESULTS


There were no significant differences in demographic characteristics between groups. There were no significant differences between groups regarding the number of oocytes retrieved (p=0.81), number of embryos transferred (p=0.82), fertilization rate (p=0.225), implantation rate (p=0.72), total cycle cancelation rate (p=0.08), and clinical pregnancy rate (p=0.12).
CONCLUSION


The use of letrozole in GnRH-antagonist cycles does not improve clinical outcomes in poor responder patients undergoing intracytoplasmic sperm injection.",2017,"There were no significant differences between groups regarding the number of oocytes retrieved (p=0.81), number of embryos transferred (p=0.82), fertilization rate (p=0.225), implantation rate (p=0.72), total cycle cancelation rate (p=0.08), and clinical pregnancy rate (p=0.12).
","['poor ovarian responders undergoing intracytoplasmic sperm injection cycles', 'ovarian stimulation of poor responder patients undergoing intracytoplasmic sperm injection', 'group (n=35/each', '70 infertile women with poor ovarian response based on Bologna criteria in two groups', 'patients with limited ovarian reserve', 'poor responder patients undergoing intracytoplasmic sperm injection']","['GnRH-antagonist', 'placebo', 'Gonadotropin-releasing hormone (GnRH) antagonist protocol', 'recombinant human follicle stimulating hormone', 'recombinant human follicle stimulating hormone 225 IU/daily', 'GnRH-antagonist protocol', 'letrozole+GnRH-antagonist (LA) group and placebo+GnRH-antagonist (PA', 'Letrozole+ GnRH antagonist stimulation protocol', 'letrozole']","['demographic characteristics', 'number of embryos transferred (p=0.82), fertilization rate', 'clinical pregnancy rate', 'total cycle cancelation rate', 'implantation rate', 'number of oocytes', 'number of oocytes retrieved, fertilization rate, implantation rate, cycle cancellation rate, and clinical pregnancy rate', 'clinical pregnancy']","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0016774', 'cui_str': 'Follicle Stimulating Hormone, Human'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred (qualifier value)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",70.0,0.488573,"There were no significant differences between groups regarding the number of oocytes retrieved (p=0.81), number of embryos transferred (p=0.82), fertilization rate (p=0.225), implantation rate (p=0.72), total cycle cancelation rate (p=0.08), and clinical pregnancy rate (p=0.12).
","[{'ForeName': 'Mahbod', 'Initials': 'M', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Obstetrics and Gynecology, IVF Unit, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Firouzeh', 'Initials': 'F', 'LastName': 'Akbari-Asbagh', 'Affiliation': 'Department of Obstetrics and Gynecology, IVF Unit, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Ghalandar-Attar', 'Affiliation': 'Department of Obstetrics and Gynecology, IVF Unit, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
828,28190457,Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US.,"Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled data sharing; or broad consent and open data sharing. Of 82,328 eligible individuals, exactly 13,000 (15.8%) completed the survey. Overall, 66% (95% CI: 63%-69%) of population-weighted respondents stated they would be willing to participate in a biobank; willingness and attitudes did not differ between respondents in the three scenarios. Willingness to participate was associated with self-identified white race, higher educational attainment, lower religiosity, perceiving more research benefits, fewer concerns, and fewer information needs. Most (86%, CI: 84%-87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%-55%) would worry about their privacy. The concern that the use of broad consent and open data sharing could adversely affect participant recruitment is not supported by these findings. Addressing potential participants' concerns and information needs and building trust and relationships with communities may increase acceptance of broad consent and wide data sharing in biobank research.",2017,"Most (86%, CI: 84%-87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%-55%) would worry about their privacy.","['individuals from 11\xa0US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network', 'Individuals participating in biobanks and other large research projects', '82,328 eligible individuals, exactly 13,000 (15.8%) completed the survey']",['hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled data sharing; or broad consent and open data sharing'],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2713450', 'cui_str': 'Data Sharing'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",[],82328.0,0.0501977,"Most (86%, CI: 84%-87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%-55%) would worry about their privacy.","[{'ForeName': 'Saskia C', 'Initials': 'SC', 'LastName': 'Sanderson', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK; Great Ormond Street Hospital, London WC1N 3JH, UK; Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Electronic address: saskia.sanderson@ucl.ac.uk.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Brothers', 'Affiliation': 'Department of Pediatrics, University of Louisville, Louisville, KY 40202, USA. Electronic address: kyle.brothers@louisville.edu.'}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Mercaldo', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, TN 37203, USA.'}, {'ForeName': 'Ellen Wright', 'Initials': 'EW', 'LastName': 'Clayton', 'Affiliation': 'Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, TN 37203, USA.'}, {'ForeName': 'Armand H Matheny', 'Initials': 'AHM', 'LastName': 'Antommaria', 'Affiliation': ""Ethics Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Aufox', 'Affiliation': 'Center for Genetic Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Murray H', 'Initials': 'MH', 'LastName': 'Brilliant', 'Affiliation': 'Center for Human Genetics, Marshfield Clinic Research Foundation, Marshfield, WI 54449, USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': ""Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Carrell', 'Affiliation': 'Group Health Research Institute, Seattle, WA 98101, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Connolly', 'Affiliation': ""Center for Applied Genomics, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.""}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Conway', 'Affiliation': 'Essentia Institute of Rural Health, Duluth, MN 55805, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': ""Nanibaa' A"", 'Initials': 'NA', 'LastName': 'Garrison', 'Affiliation': ""Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA 98101, USA; Department of Pediatrics, Division of Bioethics, University of Washington, Seattle, WA 98101, USA.""}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaufman', 'Affiliation': 'Division of Genomics and Society, National Human Genome Research Institute, Bethesda, MD 20892, USA.'}, {'ForeName': 'Terrie E', 'Initials': 'TE', 'LastName': 'Kitchner', 'Affiliation': 'Center for Human Genetics, Marshfield Clinic Research Foundation, Marshfield, WI 54449, USA.'}, {'ForeName': 'Rongling', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Division of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD 20892, USA.'}, {'ForeName': 'Evette J', 'Initials': 'EJ', 'LastName': 'Ludman', 'Affiliation': 'Group Health Research Institute, Seattle, WA 98101, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'McCarty', 'Affiliation': 'Essentia Institute of Rural Health, Duluth, MN 55805, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McCormick', 'Affiliation': 'Biomedical Ethics Program, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Valerie D', 'Initials': 'VD', 'LastName': 'McManus', 'Affiliation': 'Biomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, WI 54449, USA.'}, {'ForeName': 'Melanie F', 'Initials': 'MF', 'LastName': 'Myers', 'Affiliation': ""Genetic Counseling Graduate Program, Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Scrol', 'Affiliation': 'Group Health Research Institute, Seattle, WA 98101, USA.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Williams', 'Affiliation': 'Genomic Medicine Institute, Geisinger Health System, Danville, PA 17822, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Vanderbilt Epidemiology Center, Vanderbilt University Medical Center, Nashville, TN 37203, USA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Schildcrout', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, TN 37203, USA.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Smith', 'Affiliation': 'Center for Genetic Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Holm', 'Affiliation': ""Division of Genetics and Genomics and the Manton Center for Orphan Diseases Research, Boston Children's Hospital, Boston, MA 02115, USA.""}]",American journal of human genetics,['10.1016/j.ajhg.2017.01.021']
829,28066833,The role of G-CSF in recurrent implantation failure: A randomized double blind placebo control trial.,"BACKGROUND


Recurrent implantation failure (RIF) is the absence of implantation after three consecutive In Vitro Fertilization (IVF) cycles with transferring at least four good quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years. The definition and management of RIF is under constant scrutiny.
OBJECTIVE


To investigate the effects of Granulocyte colony stimulating factor (G-CSF) on RIF, pregnancy rate, abortion rate and implantation rates.
MATERIALS AND METHODS


A double blind placebo controlled randomized trial was conducted at two tertiary university based hospitals. One hundred patients with the history of RIF from December 2011 until January 2014 were recruited in the study. G-CSF 300µg/1ml was administered at the day of oocyte puncture or day of progesterone administration of FET cycle. Forty patients were recruited at G-CSF group, 40 in saline and 20 in placebo group.
RESULTS


The mean age for whole study group was 35.3±4.2 yrs (G-CSF 35.5±4.32, saline 35.3±3.98, placebo 35.4±4.01, respectively). Seventeen patients had a positive pregnancy test after embryo transfer [10 (25%) in G-CSF; 5 (12.5%) in saline; and 2 (10%) in placebo group]. The mean of abortion rates was 17.6% (3), two of them in G-CSF, one in saline group. The implantation rate was 12.3% in G-CSF, 6.1% in saline and 4.7% in placebo group.
CONCLUSION


G-CSF may increase chemical pregnancy and implantation rate in patients with recurrent implantation failure but clinical pregnancy rate and abortion rate was unaffected.",2016,G-CSF may increase chemical pregnancy and implantation rate in patients with recurrent implantation failure but clinical pregnancy rate and abortion rate was unaffected.,"['two tertiary university based hospitals', 'Forty patients were recruited at G-CSF group, 40 in saline and 20 in placebo group', 'recurrent implantation failure', 'One hundred patients with the history of RIF from December 2011 until January 2014 were recruited in the study', 'patients with recurrent implantation failure']","['Granulocyte colony stimulating factor (G-CSF', 'G-CSF', 'placebo']","['clinical pregnancy rate and abortion rate', 'chemical pregnancy and implantation rate', 'positive pregnancy test after embryo transfer', 'mean of abortion rates', 'implantation rate', 'RIF, pregnancy rate, abortion rate and implantation rates']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive (finding)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",100.0,0.603229,G-CSF may increase chemical pregnancy and implantation rate in patients with recurrent implantation failure but clinical pregnancy rate and abortion rate was unaffected.,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Davari-Tanha', 'Affiliation': 'Department of Reproductive Endocrinology, Women Hospital, Vali-e-Asr Health Reproductive Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Shahrokh Tehraninejad', 'Affiliation': 'Department of Reproductive Endocrinology, Vali-e-Asr Hospital, Vali-e-Asr Health Reproductive Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohadese', 'Initials': 'M', 'LastName': 'Ghazi', 'Affiliation': 'Department of Reproductive Endocrinology, Women Hospital, Vali-e-Asr Health Reproductive Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shahraki', 'Affiliation': 'Department of Reproductive Endocrinology, Women Hospital, Vali-e-Asr Health Reproductive Center, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
830,28066834,"The role of ventilation mode using a laryngeal mask airway during gynecological laparoscopy on lung mechanics, hemodynamic response and blood gas analysis.","BACKGROUND


There are two methods for ventilation in gynecological laparoscopy: volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV).
OBJECTIVE


To compare the lung mechanics, hemodynamic response and arterial blood gas analysis and gas exchange of two modes of VCV and PCV using laryngeal mask airway (LMA) at different time intervals.
MATERIALS AND METHODS


Sixty infertile women referred for diagnostic laparoscopy, based on ventilation mode, were randomly divided into two groups of VCV (tidal volume: 10 ml/kg) and PCV. In the PCV group, ventilation was initiated with a peak airway pressure (tidal volume: 10 ml/kg, upper limit: 35 cm H 2 O). In both groups, the arterial blood samples were taken in several time intervals (5, 10 and 15 min after LMA insertion) for blood gas evaluation. Also the lung mechanics parameters were continuously monitored and were recorded at different time intervals.
RESULTS


There were no significant differences for patient's age, weight, height and BMI in two groups. The peak and plateau airway pressure were significantly higher in VCV group compared to PCV group 5 and 10 min after insertion of LMA. PaO 2  was significantly higher after 10 and 15 min in VCV group compared to PCV group (p=0.005 and p=0.03, respectively). PaCO 2  showed significant increase after 5 min in PCV group, but the differences were not significant after 10 and 15 min in two groups. The end tidal CO 2  showed significant increase after 10 and 15 min in VCV compared to PCV group.
CONCLUSION


Both VCV and PCV seem to be suitable for gynecological laparoscopy. However, airway pressures are significantly lower in PCV compared to VCV.",2016,"PaO 2  was significantly higher after 10 and 15 min in VCV group compared to PCV group (p=0.005 and p=0.03, respectively).","['Sixty infertile women referred for diagnostic laparoscopy, based on ventilation mode']","['VCV (tidal volume: 10 ml/kg) and PCV', 'VCV', 'PCV', 'VCV and PCV using laryngeal mask airway (LMA']","['airway pressures', 'arterial blood samples', 'PaO 2', 'peak and plateau airway pressure', 'lung mechanics, hemodynamic response and blood gas analysis']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1880304', 'cui_str': 'Diagnostic laparoscopy (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0444253', 'cui_str': 'Arterial blood specimen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}]",60.0,0.0227925,"PaO 2  was significantly higher after 10 and 15 min in VCV group compared to PCV group (p=0.005 and p=0.03, respectively).","[{'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Jarahzadeh', 'Affiliation': 'Anesthesiology and Critical Care Department, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Halvaei', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Rahimi-Bashar', 'Affiliation': 'Anesthesiology and Critical Care Department, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Shekoufeh', 'Initials': 'S', 'LastName': 'Behdad', 'Affiliation': 'Anesthesiology and Critical Care Department, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Rouhollah', 'Initials': 'R', 'LastName': 'Abbasizadeh Nasrabady', 'Affiliation': 'Anesthesiology and Critical Care Department, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Yasaei', 'Affiliation': 'Anesthesiology and Critical Care Department, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
831,4083810,Is preoperative shaving really necessary?,"A randomised prospective study was done to assess the necessity of shaving before operation. Seven hundred and sixteen cases were included in this study. The traditional method of preoperative skin preparation which employs routine shaving and using cetrimide and chlorhexidine in alcohol for cleansing was compared with an alternate method without preoperative shaving. The clean wound infection rate was 5.08% for the traditional method group and 5.56% for the alternate method group. The results suggest that routine shaving, as part of preoperative preparation, has no advantage in reducing wound infection rate.",1985,The clean wound infection rate was 5.08% for the traditional method group and 5.56% for the alternate method group.,['Seven hundred and sixteen cases'],['cetrimide and chlorhexidine'],"['clean wound infection rate', 'wound infection rate']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0007903', 'cui_str': 'Cetrimides'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0455099', 'cui_str': 'Cleaning wound (procedure)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}]",716.0,0.0166058,The clean wound infection rate was 5.08% for the traditional method group and 5.56% for the alternate method group.,"[{'ForeName': 'N Y', 'Initials': 'NY', 'LastName': 'Hoe', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nambiar', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
832,27738660,Does intrauterine saline infusion by intrauterine insemination (IUI) catheter as endometrial injury during IVF cycles improve pregnancy outcomes among patients with recurrent implantation failure?: An RCT.,"BACKGROUND


Recurrent implantation failure is one of the most issues in IVF cycles. Some researchers found that beneficial effects of endometrial Scratching in women with recurrent implantation failure, while some authors demonstrated contrary results.
OBJECTIVE


The present study aimed to investigate the effect of intrauterine. Saline infusion as a form of endometrial injury, during fresh in vitro fertilization-embryo transfer cycle, among patients with recurrent implantation failure.
MATERIALS AND METHODS


In this clinical trial study 63 women undergoing assisted reproductive technology were divided into two groups either local endometrial injury by intrauterine saline infusion during day 3-5 of the ongoing controlled ovarian stimulation cycle, or IVF protocol performed without any other intervention in Taleghani Hospital, Tehran, Iran. The main outcome measure was clinical pregnancy rates.
RESULTS


Patients who received intra uterine saline infusion (n=20), had significantly lower clinical pregnancy numbers (1 vs. 9, p<0.05) and implantation rates (4.7% vs. 41.6%, p<0.05), compared to controls (n=39). However, there was no significant difference in miscarriage rates (9.4% vs. 8.7%, p>0.05) and multiple pregnancy numbers (1 vs. 3, p>0.05) between groups.
CONCLUSION


When intrauterine saline infusion as a form of endometrial injury is performed during the ongoing IVF cycles it has negative effect on reproductive outcomes among patients with recurrent implantation failure.",2016,"However, there was no significant difference in miscarriage rates (9.4% vs. 8.7%, p>0.05) and multiple pregnancy numbers (1 vs. 3, p>0.05) between groups.
","['patients with recurrent implantation failure', 'women with recurrent implantation failure', '63 women undergoing assisted reproductive technology']","['intra uterine saline infusion', 'local endometrial injury by intrauterine saline infusion during day 3-5 of the ongoing controlled ovarian stimulation cycle, or IVF protocol performed without any other intervention in Taleghani Hospital, Tehran, Iran', 'Saline infusion', 'intrauterine saline infusion by intrauterine insemination (IUI) catheter']","['miscarriage rates', 'implantation rates', 'clinical pregnancy numbers', 'clinical pregnancy rates', 'multiple pregnancy numbers', 'pregnancy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0585022', 'cui_str': 'During day (qualifier value)'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}]",63.0,0.455007,"However, there was no significant difference in miscarriage rates (9.4% vs. 8.7%, p>0.05) and multiple pregnancy numbers (1 vs. 3, p>0.05) between groups.
","[{'ForeName': 'Saghar', 'Initials': 'S', 'LastName': 'Salehpour', 'Affiliation': 'Preventive Gynecology Research Center (PGRC), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Zamaniyan', 'Affiliation': 'Preventive Gynecology Research Center (PGRC), Shahid Beheshti University of Medical Sciences, Tehran, Iran.; Infertility Center, Department of Obstetrics and Gynecology, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Saharkhiz', 'Affiliation': 'Preventive Gynecology Research Center (PGRC), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Zadeh Modares', 'Affiliation': 'Preventive Gynecology Research Center (PGRC), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Hosieni', 'Affiliation': 'Preventive Gynecology Research Center (PGRC), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Seif', 'Affiliation': 'Department of Veterinary Theriogenology and Obstetric, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Malih', 'Affiliation': 'Department of Health and Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parinaz', 'Initials': 'P', 'LastName': 'Rezapoor', 'Affiliation': 'Department of Health and Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Sohrabi', 'Affiliation': 'Department of Health and Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
833,27679829,The influence of ginger (Zingiber officinale) on human sperm quality and DNA fragmentation: A double-blind randomized clinical trial.,"BACKGROUND


Although the effectiveness of ginger as an antioxidant agent has been exploited, little human research has been conducted on its activity on male reproductive functions.
OBJECTIVE


This study was designed to investigate the effects of ginger (Zingiber officinale) on sperm DNA fragmentation (SDF) in infertile men.
MATERIALS AND METHODS


This randomized double-blind, placebo-controlled trial with a 1:1 allocation was performed on 100 infertility treatment candidates who were admitted to Royan Institute for Reproductive Biomedicine, Tehran, Iran. Patients were randomly assigned to receive one of two treatments: ginger and placebo. Patients were given a 3-month oral treatment (members received capsules containing 250 mg of ginger powder twice a day in ginger and a placebo in other group). Before and after treatment, standardized semen samples were obtained to determine sperm concentration, motility, and SDF according to World Health Organization.
RESULTS


There was no significant difference between two groups regarding SDF at baseline (53.48. 95%CI: 37.95-69.02) in cases and (56.75, 95%CI: 40.01-73.5) in controls. The average positive percentage of SDF in patients receiving ginger (17.77, 95%CI: 6.16-29.39) was lower compared with placebo (40.54, 95%CI: 23.94-57.13) after three month of treatment (p=0.02). In multivariate analysis, SDF was significantly lower in patients receiving ginger compared with placebo (mean difference: 3.21, 95%CI: 0.78-5.63, p=0.009). There were no significant differences between two groups regarding to semen parameters.
CONCLUSION


The present study has demonstrated that ginger in a controlled study of efficacy was effective in decreasing SDF in infertile men.",2016,"In multivariate analysis, SDF was significantly lower in patients receiving ginger compared with placebo (mean difference: 3.21, 95%CI: 0.78-5.63, p=0.009).","['infertile men', '100 infertility treatment candidates who were admitted to Royan Institute for Reproductive Biomedicine, Tehran, Iran']","['capsules containing 250 mg of ginger powder twice a day in ginger and a placebo', 'ginger (Zingiber officinale', 'ginger and placebo', 'placebo']","['average positive percentage of SDF', 'sperm concentration, motility, and SDF according to World Health Organization', 'SDF', 'human sperm quality and DNA fragmentation', 'sperm DNA fragmentation (SDF']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}]",100.0,0.679493,"In multivariate analysis, SDF was significantly lower in patients receiving ginger compared with placebo (mean difference: 3.21, 95%CI: 0.78-5.63, p=0.009).","[{'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Hosseini', 'Affiliation': 'Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.; Department of Andrology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Mardi Mamaghani', 'Affiliation': 'Department of Andrology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Hosseinifar', 'Affiliation': 'Department of Andrology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sadighi Gilani', 'Affiliation': 'Department of Andrology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.; Department of Urology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Dadkhah', 'Affiliation': 'Department of Andrology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': 'Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran. ; Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
834,27326415,Vaginal progesterone on the prevention of preterm birth and neonatal complications in high risk women: A randomized placebo-controlled double-blind study.,"BACKGROUND


Preterm birth is the major cause of neonatal mortality and morbidity.
OBJECTIVE


The aim of this study was to evaluate the effect of prophylactic vaginal progesterone on decreasing preterm birth rate and neonatal complications in a high-risk population.
MATERIALS AND METHODS


A randomized, double-blind, placebo-controlled study was performed on 100 high-risk singleton pregnancies. Vaginal suppository progesterone (400 mg) or placebo was administered daily between 16-22 wks to 36 wks of gestation. Progesterone (n=50) and placebo (n=50) groups were compared for incidence of preterm delivery and neonatal complications.
RESULTS


The preterm birth rate was 52%. Preterm birth rate before the 37 wks of gestation (68% vs. 36%: RR=1.89, 95% CI: 1.25-2.86) and also before the 34 wks of gestation (42% vs. 18%: RR=2.33, 95% CI: 1.19-4.58) in placebo group was significantly higher than progesterone group. Our study also showed that the administration of vaginal progesterone was associated with a significant reduction in the risk of birth weight ≤2500 gr, the rates of respiratory distress syndrome (RDS) and admission to the Neonatal Intensive Care Unit (NICU) in the progesterone group when compared with the placebo group. However, there was no significant difference between the two groups in terms of neonatal death, days of admission in NICU, intraventricular hemorrhage and necrotizing enterocolitis.
CONCLUSION


Prophylactic vaginal progesterone reduced the rate of preterm delivery, the risk of a birth weight ≤2500 gr, the rates of RDS and admission to NICU in women who were at risk of preterm delivery.",2016,"(42% vs. 18%: RR=2.33, 95% CI: 1.19-4.58) in placebo group was significantly higher than progesterone group.","['100 high-risk singleton pregnancies', 'n=50', 'high risk women']","['Vaginal suppository progesterone', 'placebo', 'Progesterone', 'Vaginal progesterone', 'progesterone', 'vaginal progesterone', 'Prophylactic vaginal progesterone', 'prophylactic vaginal progesterone']","['neonatal death, days of admission in NICU, intraventricular hemorrhage and necrotizing enterocolitis', 'preterm birth rate and neonatal complications', 'Preterm birth rate', 'rate of preterm delivery, the risk of a birth weight ≤2500 gr, the rates of RDS and admission to NICU', 'preterm birth rate', 'preterm birth and neonatal complications', 'incidence of preterm delivery and neonatal complications', 'rates of respiratory distress syndrome (RDS) and admission to the Neonatal Intensive Care Unit (NICU']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1136199', 'cui_str': 'Vaginal Suppository'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}]",100.0,0.778242,"(42% vs. 18%: RR=2.33, 95% CI: 1.19-4.58) in placebo group was significantly higher than progesterone group.","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Azargoon', 'Affiliation': 'Abnormal Uterine Bleeding Research Center, Semnan University of Medical Sciences, Semnan, Iran.; Department of Infertility, Amir-AL-Momenin Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Raheb', 'Initials': 'R', 'LastName': 'Ghorbani', 'Affiliation': 'Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Aslebahar', 'Affiliation': 'Abnormal Uterine Bleeding Research Center, Semnan University of Medical Sciences, Semnan, Iran.; Department of Infertility, Amir-AL-Momenin Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
835,32416145,Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.,"OBJECTIVE


To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism.
STUDY DESIGN


We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.
RESULTS


Sixty-five participants enrolled in E2 75 (n = 22), 100 (n = 21), and 200 (n = 22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days.
CONCLUSIONS


Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use.
IMPLICATIONS


A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.",2020,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"['Sixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22) mcg/day groups; 35 participated in the substudy', 'healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups']","['contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate', '90-day contraceptive vaginal ring releasing estradiol and segesterone acetate', '2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information', 'segesterone acetate (SA']","['zero median unscheduled bleeding or spotting days', 'withdrawal bleeding', 'median E2 concentrations', 'Median serum E2 concentrations', 'serum estradiol (E2) concentrations', 'zero median unscheduled bleeding']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C4723383', 'cui_str': 'Segesterone acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152010', 'cui_str': 'Withdrawal bleeding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]",65.0,0.194795,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States. Electronic address: mejchen@ucdavis.edu.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomas', 'Affiliation': 'Reproductive Medicine Research, Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH, United States.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Health Decisions, Durham, NC, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}]",Contraception,['10.1016/j.contraception.2020.05.004']
836,27326420,Effect of granulocyte colony stimulating factor (G-CSF) on IVF outcomes in infertile women: An RCT.,"BACKGROUND


Despite major advances in assisted reproductive techniques, the implantation rates remain relatively low. Some studies have demonstrated that intrauterine infusion of granulocyte colony stimulating factor (G-CSF) improves implantation in infertile women.
OBJECTIVE


To assess the G-CSF effects on IVF outcomes in women with normal endometrial thickness.
MATERIALS AND METHODS


In this randomized controlled clinical trial, 100 infertile women with normal endometrial thickness who were candidate for IVF were evaluated in two groups. Exclusion criteria were positive history of repeated implantation failure (RIF), endocrine disorders, severe endometriosis, congenital or acquired uterine anomaly and contraindication for G-CSF (renal disease, sickle cell disease, or malignancy). In G-CSF group (n=50), 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day. Controls (n=50) were treated with standard protocol. Chemical, clinical and ongoing pregnancy rates, implantation rate, and miscarriage rate were compared between groups.
RESULTS


Number of total and mature oocytes (MII), two pronuclei (2PN), total embryos, transferred embryos, quality of transferred embryos, and fertilization rate did not differ significantly between two groups. So there were no significant differences between groups in chemical, clinical and ongoing pregnancy rate, implantation rate, and miscarriage rate.
CONCLUSION


our result showed in normal IVF patients with normal endometrial thickness, the intrauterine infusion of G-CSF did not improve pregnancy outcomes.",2016,"So there were no significant differences between groups in chemical, clinical and ongoing pregnancy rate, implantation rate, and miscarriage rate.
","['normal IVF patients with normal endometrial thickness', 'infertile women', '100 infertile women with normal endometrial thickness who were candidate for IVF were evaluated in two groups', 'Exclusion criteria were positive history of repeated implantation failure (RIF), endocrine disorders, severe endometriosis, congenital or acquired uterine anomaly and contraindication for G-CSF (renal disease, sickle cell disease, or malignancy', 'women with normal endometrial thickness']","['granulocyte colony stimulating factor (G-CSF', 'G-CSF']","['Chemical, clinical and ongoing pregnancy rates, implantation rate, and miscarriage rate', 'chemical, clinical and ongoing pregnancy rate, implantation rate, and miscarriage rate', 'Number of total and mature oocytes (MII), two pronuclei (2PN), total embryos, transferred embryos, quality of transferred embryos, and fertilization rate', 'IVF outcomes', 'pregnancy outcomes']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0014130', 'cui_str': 'Endocrine System Diseases'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0266383', 'cui_str': 'Uterine Anomalies'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",100.0,0.257043,"So there were no significant differences between groups in chemical, clinical and ongoing pregnancy rate, implantation rate, and miscarriage rate.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eftekhar', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Robabe', 'Initials': 'R', 'LastName': 'Hosseinisadat', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.; Department of Obstetrics and Gynecology, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Baradaran', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Naghshineh', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
837,27523514,Comparison of Outcomes of Transcatheter and Surgical Procedure in Perimembranous Ventricular Septal Defect Patients with Tricuspid Regurgitation.,,2016,,['Perimembranous Ventricular Septal Defect Patients with Tricuspid Regurgitation'],['Transcatheter and Surgical Procedure'],[],"[{'cui': 'C0344925', 'cui_str': 'Perimembranous ventricular septal defect (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid Regurgitation'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",[],,0.0156753,,"[{'ForeName': 'Xiao Ke', 'Initials': 'XK', 'LastName': 'Shang', 'Affiliation': 'National Heart Centre, Singapore.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Gang Cheng', 'Initials': 'GC', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Qun Shan', 'Initials': 'QS', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Chang Yu', 'Initials': 'CY', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Hong Mei', 'Initials': 'HM', 'LastName': 'Zhou', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
838,32492377,Impact of submucosal saline solution injection for cold snare polypectomy of small colorectal polyps: a randomized controlled study.,"BACKGROUND AND AIMS


Cold snare polypectomy (CSP) of small colorectal polyps is widely used. However, the technique is still troubled by insufficient resection depth, which may prevent precise pathologic evaluation. In this study, we investigated whether submucosal injection of saline solution helps to achieve deeper resection in CSP.
METHODS


The study was a single-center, prospective, randomized trial. Patients with small (3- to 10-mm diameter) nonpedunculated adenomatous or sessile serrated colorectal polyps were randomly allocated to either conventional CSP (C-CSP) or CSP with submucosal injection (CSP-SI). Primary outcome was the rate of complete muscularis mucosae (MM) resection, defined by the proportion of MM under the tumor more than 80% of the tumor's horizontal dimension. Secondary outcomes were the rates of negative lateral and vertical margins, fragmentation of resected specimens, conversion to hot snare mucosal resection, intraprocedural bleeding, delayed bleeding, and perforation.
RESULTS


Two hundred fourteen patients were randomly assigned to the CSP-SI (n = 107) or C-CSP (n = 107) group. The rate of complete MM resection was 43.9% in the CSP-SI group and 53.3% in the C-CSP group, a statistically insignificant difference. The rates of negative lateral margin and vertical margin (42.3% and 56.7%, respectively) in the CSP-SI group were significantly lower than those (58% and 76%) in the C-CSP group (P = .03 and P = .006, respectively). There was no polypectomy-related major bleeding or perforation.
CONCLUSIONS


Saline solution injection into the submucosa did not improve the resection depth of CSP of small colorectal polyps, and the method resulted in lower rates of negative lateral and vertical margins of resected lesions. (Clinical trial registration number: UMIN000037980.).",2020,"The rates of negative lateral margin and vertical margin (42.3% and 56.7%, respectively) in the CSP-SI group were significantly lower than those (58% and 76%) in the C-CSP group (p=0.03 and p=0.006, respectively).","['Patients with small (3-10 mm diameter) nonpedunculated adenomatous or sessile serrated colorectal polyps', 'cold snare polypectomy of small colorectal polyps', 'Two hundred fourteen patients']","['saline solution', 'conventional CSP (C-CSP) or CSP with submucosal injection (CSP-SI', 'Cold snare polypectomy (CSP', 'submucosal saline solution injection', 'CSP-SI']","['rate of complete MM resection', 'rates of negative lateral margin and vertical margin', 'rates of negative lateral and vertical margins, fragmentation of resected specimens, conversion to hot-snare mucosal resection, intraprocedural bleeding, delayed bleeding, and perforation', 'resection depth of CSP of small colorectal polyps', ""rate of complete muscularis mucosae (MM) resection, defined by the proportion of MM under the tumor more than 80% of the tumor's horizontal dimension"", 'polypectomy-related major bleeding or perforation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0225357', 'cui_str': 'Muscularis mucosae'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0183362', 'cui_str': 'Snare'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",214.0,0.14452,"The rates of negative lateral margin and vertical margin (42.3% and 56.7%, respectively) in the CSP-SI group were significantly lower than those (58% and 76%) in the C-CSP group (p=0.03 and p=0.006, respectively).","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Shimodate', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Itakura', 'Affiliation': 'Department of Pathology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takayama', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Rio', 'Initials': 'R', 'LastName': 'Takezawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nishimura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Mouri', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Sunami', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Shumpei', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Muneaki', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Matsueda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Kurashiki Clinical Research Institute, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Motowo', 'Initials': 'M', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.039']
839,27294218,The effect of endometrial injury on first cycle IVF/ICSI outcome: A randomized controlled trial.,"BACKGROUND


Implantation remains a limiting step in IVF/ICSI. Endometrial injury isa promising procedure aiming at improving the implantation and pregnancy rates after IVF/ICSI.
OBJECTIVE


The aim of this study was to evaluate the effect of endometrial injury induced in precedingcycle on IVF/ICSI outcome.
MATERIALS AND METHODS


Four hundred patients undergoing their first IVF/ICSI cycle in two IVF units in Minia, Egypt were randomly selected to undergo either endometrial injury in luteal phase of preceding cycle (intervention group) or no treatment (control group). Primary outcome wasthe implantation and live birth ratesWhile the secondary outcome was clinical pregnancy, miscarriage, multiple pregnancy rates, pain and bleeding during and after procedure.
RESULTS


Implantation and live birth rates were significantly higher in intervention compared with control group (22.4% vs. 18.7%, p=0.02 and 67% vs. 28%, p=0.03), respectively. There was also a significant reduction in miscarriage rate in intervention group (4.8% vs. 19.7%, respectively, p<0.001).
CONCLUSION


Endometrial injury in preceding cycle improves the implantation rate and live birth rate and reduces the miscarriage rate per clinical pregnancy in patients undergoing their first IVF/ICSI cycle.",2016,Endometrial injury in preceding cycle improves the implantation rate and live birth rate and reduces the miscarriage rate per clinical pregnancy in patients undergoing their first IVF/ICSI cycle.,"['Four hundred patients undergoing their first IVF/ICSI cycle in two IVF units in Minia, Egypt', 'patients undergoing their first IVF/ICSI cycle']",['endometrial injury in luteal phase of preceding cycle (intervention group) or no treatment (control group'],"['miscarriage rate', 'miscarriage rate per clinical pregnancy', 'implantation rate and live birth rate', 'wasthe implantation and live birth ratesWhile the secondary outcome was clinical pregnancy, miscarriage, multiple pregnancy rates, pain and bleeding during and after procedure', 'implantation and pregnancy rates', 'Implantation and live birth rates']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",400.0,0.552097,Endometrial injury in preceding cycle improves the implantation rate and live birth rate and reduces the miscarriage rate per clinical pregnancy in patients undergoing their first IVF/ICSI cycle.,"[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mahran', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Bahaa', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
840,31564020,Effects of inspired oxygen concentration during emergence from general anaesthesia on postoperative lung impedance changes evaluated by electrical impedance tomography: a randomised controlled trial.,"We evaluated the effects of three different inspired oxygen concentrations (40%, 80%, and 100%) at anaesthesia emergence on postoperative lung volumes as measured by global impedance of electrical impedance tomography (EIT). This is a randomised, controlled, and assessor-blinded study in single-centre from May 2017 to August 2017. Seventy-one patients undergoing elective laparoscopic colorectal surgery with healthy lung condition were randomly allocated into the three groups based on the concentration of inspired oxygen applied during anaesthesia emergence: 40%-, 80%- or 100%-oxygen. End-expiratory lung impedance (EELI) with normal tidal ventilation and total lung impedance (TLI) with full respiratory effort were measured preoperatively and before discharge in the post-anaesthesia care unit by EIT, and perioperative changes (the ratio of difference between preoperative and postoperative value to preoperative value) were compared among the three groups. Postoperative lung impedances were significantly reduced compared with preoperative values in all patients (P < 0.001); however, perioperative lung impedance reduction (%) did not differ among the three oxygen groups. The mean reduction ratio in each 40%-, 80%-, and 100%-oxygen group were 37% ± 13%, 41% ± 14%, and 46% ± 14% for EELI (P = 0.125) and 40% ± 20%, 44% ± 17% and 49% ± 20% for TLI (P = 0.276), respectively. Inspired oxygen concentrations applied during anaesthesia emergence did not show a significant difference in postoperative lung volume as measured by EIT in patients undergoing laparoscopic colorectal surgery with healthy lungs.Trial registration cris.nih.go.kr (KCT0002642).",2020,Inspired oxygen concentrations applied during anaesthesia emergence did not show a significant difference in postoperative lung volume as measured by EIT in patients undergoing laparoscopic colorectal surgery with healthy lungs.,"['Seventy-one patients undergoing elective laparoscopic colorectal surgery with healthy lung condition', 'single-centre from May 2017 to August 2017', 'patients undergoing laparoscopic colorectal surgery with healthy lungs']","['concentration of inspired oxygen applied during anaesthesia emergence: 40%-, 80%- or 100%-oxygen', 'inspired oxygen concentration']","['Postoperative lung impedances', 'postoperative lung volumes', 'mean reduction ratio', 'global impedance of electrical impedance tomography (EIT', 'End-expiratory lung impedance (EELI) with normal tidal ventilation and total lung impedance (TLI', 'perioperative lung impedance reduction', 'postoperative lung volume', 'oxygen concentrations']","[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration (observable entity)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration (observable entity)'}]",71.0,0.0584556,Inspired oxygen concentrations applied during anaesthesia emergence did not show a significant difference in postoperative lung volume as measured by EIT in patients undergoing laparoscopic colorectal surgery with healthy lungs.,"[{'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyukwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyukwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Jong-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyukwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyukwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyukwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea. prudence2@hanmail.net.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00390-0']
841,32418064,Acute assessment of subjective appetite and implicated hormones after a hypnosis-induced hallucinated meal: a randomized cross-over pilot trial.,"The use of hypnosis can generate hallucinatory phenomena, which ranged from vivid/auditory imagery to fully developed ""hallucinations"" in selected people. The aim of this pilot trial was investigating the acute effects of a hypnosis-induced hallucinated breakfast (HB) compared to those of a real breakfast (RB) on subjective appetite and appetite-regulating hormones in highly hypnotizable individuals. Eight healthy post-menopausal women were recruited to consume two meals: the HB and the RB in a randomized crossover design. Participants underwent appetite sensations measurements (before meal and each 30-min until 270-min) and blood sample collection (at 0, 20, 60, 90, 180-min). A 3-day food-record was filled after each meal. The adjusted repeated measures ANCOVA did not show any meal×time interactions on subjective appetite postprandially. As expected, significantly higher glucose (p < 0.001), insulin (p < 0.001), and lower free fatty acid (p < 0.001) concentrations were found after the RB, but not following HB. Furthermore, RB significantly increased postprandial levels of glucagon-like-peptide-1 and peptide-YY at 20, 60, 90 and 180-min, whereas acylated-ghrelin and leptin levels did not differ. Postprandial neuropeptide-Y and orexin-A values significantly increased at different time-points after RB, but not following HB, while α-melanocyte-stimulating hormone levels enhanced after HB only. Energy intakes were significantly lower after HB on the test-day only (HB = 1146.6 ± 343.8 vs RB = 1634.7 ± 274.2 kcal/d; p = 0.003). Appetite sensation might be modulated by fully developed meal ""hallucination"" induced by hypnosis, likely affecting brain-peptides implicated in the appetite regulation. However, further studies are needed to verify these results obtained in a highly selected group of individuals. NCT03934580.",2020,"As expected, significantly higher glucose (p < 0.001), insulin (p < 0.001), and lower free fatty acid (p < 0.001) concentrations were found after the RB, but not following HB.","['highly hypnotizable individuals', 'Eight healthy post-menopausal women']","['appetite sensations measurements', 'hypnosis-induced hallucinated breakfast (HB', 'hypnosis-induced hallucinated meal', 'real breakfast (RB']","['Energy intakes', 'free fatty acid', 'subjective appetite and appetite-regulating hormones', 'Postprandial neuropeptide-Y and orexin', 'acylated-ghrelin and leptin levels', 'postprandial levels of glucagon-like-peptide-1 and peptide-YY', 'Appetite sensation']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0027893', 'cui_str': 'Neuropeptide Y'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.059508,"As expected, significantly higher glucose (p < 0.001), insulin (p < 0.001), and lower free fatty acid (p < 0.001) concentrations were found after the RB, but not following HB.","[{'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Cioffi', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gambino', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Rosato', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy.'}, {'ForeName': 'Bice', 'Initials': 'B', 'LastName': 'Properzi', 'Affiliation': 'Unit of Internal Medicine, Hospital of Turin, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Regaldo', 'Affiliation': 'Obstetric Department, Hospital of Ciriè, Turin, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ponzo', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Contaldo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Pasanisi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Ghigo', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bo', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy. simona.bo@unito.it.'}]",Reviews in endocrine & metabolic disorders,['10.1007/s11154-020-09559-4']
842,27137199,The effects of intranasal oxytocin in opioid-dependent individuals and healthy control subjects: a pilot study.,"RATIONALE


There has been an explosion of research on the potential benefits of the social neuropeptide oxytocin for a number of mental disorders including substance use disorders. Recent evidence suggests that intranasal oxytocin has both direct anti-addiction effects and pro-social effects that may facilitate engagement in psychosocial treatment for substance use disorders.
OBJECTIVES


We aimed to assess the tolerability of intranasal oxytocin and its effects on heroin craving, implicit association with heroin and social perceptual ability in opioid-dependent patients receiving opioid replacement therapy (ORT) and healthy control participants.
METHODS


We performed a randomized, double-blind, placebo-controlled, within- and between-subjects, crossover, proof-of-concept trial to examine the effects of oxytocin (40 international units) on a cue-induced craving task (ORT patients only), an Implicit Association Task (IAT), and two social perception tasks: the Reading the Mind in the Eyes Task (RMET) and The Awareness of Social Inference Test (TASIT).
RESULTS


Oxytocin was well tolerated by patients receiving ORT but had no significant effects on craving or IAT scores. There was a significant reduction in RMET performance after oxytocin administration versus placebo in the patient group only, and a significant reduction in TASIT performance after oxytocin in both the patient and healthy control groups.
CONCLUSIONS


A single dose of intranasal oxytocin is well tolerated by patients receiving ORT, paving the way for future investigations. Despite no significant improvement in craving or IAT scores after a single dose of oxytocin and some evidence that social perception was worsened, further investigation is required to determine the role oxytocin may play in the treatment of opioid use disorder.
CLINICAL TRIAL REGISTRATION


Methadone Oxytocin Option. ClinicalTrials.gov identifier: NCT01728909.",2016,"There was a significant reduction in RMET performance after oxytocin administration versus placebo in the patient group only, and a significant reduction in TASIT performance after oxytocin in both the patient and healthy control groups.
","['opioid-dependent individuals and healthy control subjects', 'opioid-dependent patients receiving opioid replacement therapy (ORT) and healthy control participants']","['oxytocin', 'placebo', 'cue-induced craving task (ORT patients only), an Implicit Association Task (IAT), and two social perception tasks', 'intranasal oxytocin', 'social neuropeptide oxytocin', 'Oxytocin']","['RMET performance', 'tolerated', 'TASIT performance', 'craving or IAT scores']","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C2936530', 'cui_str': 'Opioid Replacement Therapy'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0037427', 'cui_str': 'Social Perception'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.160034,"There was a significant reduction in RMET performance after oxytocin administration versus placebo in the patient group only, and a significant reduction in TASIT performance after oxytocin in both the patient and healthy control groups.
","[{'ForeName': 'Josh D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, 401 Parnassus Ave, San Francisco, CA, 94143, USA. Josh.Woolley@ucsf.edu.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Arcuni', 'Affiliation': 'Department of Mental Health, San Francisco Veterans Affairs Medical Center, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, 401 Parnassus Ave, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fulford', 'Affiliation': 'Sargent College of Health & Rehabilitation Sciences, Boston University, 635 Commonwealth Ave, SAR-512, Boston, MA, 02215, USA.'}, {'ForeName': 'Dean S', 'Initials': 'DS', 'LastName': 'Carson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Standford, CA, 94305, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, 401 Parnassus Ave, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, 401 Parnassus Ave, San Francisco, CA, 94143, USA.'}]",Psychopharmacology,['10.1007/s00213-016-4308-8']
843,32419688,Dietary intake and processes of behaviour change in a nutrition education intervention for pregnant women in rural Malawi: a cluster-randomised controlled trial.,"OBJECTIVE


To examine if increased intake of locally available nutrient-dense foods among pregnant women improved the quality of their dietary intake and if use of the Theory of Planned Behaviour could explain changes in their dietary behaviour.
DESIGN


We used data from a randomised controlled trial where the intervention group received nutrition education and dietary counselling. We promoted the use of recipes that utilised powders to enhance dietary diversity. We examined how the intervention achieved changes in dietary intakes and used mixed effects logistic regression models with random effects at village level to explore changes over time of the outcomes, adjusted for selected explanatory variables.
SETTING


The study was conducted in twenty villages in rural Malawi.
PARTICIPANTS


Data from 257 pregnant women who were enrolled during late first trimester and followed until birth.
RESULTS


The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods. A third of the women in the intervention group attained optimal DDS, whereas about 50 % attained optimal SFG. The theorised behaviour mediators (i.e. nutrition attitudes, nutrition behaviour control and subjective norm) that had improved were also significantly associated with high DDS.
CONCLUSIONS


Improved dietary intakes were achieved through promoting the use of locally available nutrient-dense foods. Attainment of high DDS was a consequence of the women's belief in the effectiveness of the proposed nutrition recommendations. We identified critical personal and environmental constraints related to dietary intakes during pregnancy in a low-resource setting.",2020,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","['twenty villages in rural Malawi', 'Data from 257 pregnant women who were enrolled during late first trimester and followed until birth', 'pregnant women in rural Malawi', 'pregnant women']","['nutrition education and dietary counselling', 'nutrition education intervention']","['Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods', 'optimal DDS']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]",257.0,0.0758828,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","[{'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Ziyenda Katenga-Kaunda', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Holmboe-Ottesen', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Fjeld', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Penjani Rhoda', 'Initials': 'PR', 'LastName': 'Kamudoni', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980020000294']
844,30019070,Effectiveness of the eCARE Programme: A Short Message Service (SMS) for Asthma Monitoring.,,2018,,[],['eCARE Programme'],[],[],[],[],,0.0218508,,"[{'ForeName': 'Lathy', 'Initials': 'L', 'LastName': 'Prabhakaran', 'Affiliation': 'Nursing, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Chun Wei', 'Initials': 'CW', 'LastName': 'Yap', 'Affiliation': ''}, {'ForeName': 'Lay Ping', 'Initials': 'LP', 'LastName': 'Neo', 'Affiliation': ''}, {'ForeName': 'Chi Ching', 'Initials': 'CC', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'Lai Mei', 'Initials': 'LM', 'LastName': 'Tham', 'Affiliation': ''}, {'ForeName': 'Wai Mun', 'Initials': 'WM', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Abisheganaden', 'Affiliation': ''}, {'ForeName': 'Tow Keang', 'Initials': 'TK', 'LastName': 'Lim', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
845,27007272,Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial.,"BACKGROUND


Despite most bariatric procedures are actually performed by laparoscopic approach, management of postoperative pain remains a major challenge. The aim of this study was to analyze the analgesic effect of intraperitoneal ropivacaine infusion in patients undergoing bariatric surgery.
METHODS


A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) between January and November 2015 was performed. Patients were randomized to experimental (EG: those patients undergoing intraperitoneal ropivacain irrigation) and control groups (CG: those undergoing intraperitoneal irrigation with normal saline).
RESULTS


One hundred ten patients were included, 83 LRYGB (75.5 %) and 27 LSG (24.5 %). Mean pain, as measured by VAS score, was 21.7 ± 14.5 mm in CG and 13.3 ± 10.9 mm in EG (p = 0.002). Morphine needs during the first 24 h postoperatively were 21.8 % in CG and 3.6 % in EG (p = 0.01). Early taking of fluids by mouth was possible 6 h after surgery in 76.4 % in EG vs 34.5 % in CG (p = 0.001). Early mobilization ability (6 h after surgery) was feasible in 72.7 % in EG and 32.7 % in CG (p = 0.001). Median hospital stay was 3 days (range 2-10 days) in CG and 2 days (2-7 days) in EG (p = 0.009).
CONCLUSIONS


The intraoperative peritoneal infusion with ropivacaine in patients undergoing bariatric surgery is associated with a reduction in postoperative pain, lower morphine needs, earlier mobilization and earlier oral intake of fluids after surgery, and a shorter hospital stay. ClinicalTrials.gov Identifier: NCT02641288.",2016,"The intraoperative peritoneal infusion with ropivacaine in patients undergoing bariatric surgery is associated with a reduction in postoperative pain, lower morphine needs, earlier mobilization and earlier oral intake of fluids after surgery, and a shorter hospital stay.","['patients undergoing bariatric surgery', 'Patients', 'One hundred ten patients were included, 83 LRYGB (75.5\xa0%) and 27 LSG (24.5\xa0', 'patients undergoing']","['Morphine', 'laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB', 'Intraperitoneal Ropivacaine Irrigation', 'Undergoing Bariatric Surgery', 'intraperitoneal ropivacain irrigation) and control groups (CG: those undergoing intraperitoneal irrigation with normal saline', 'ropivacaine', 'intraperitoneal ropivacaine']","['VAS score', 'Mean pain', 'Median hospital stay', 'Early mobilization ability', 'analgesic effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",110.0,0.081288,"The intraoperative peritoneal infusion with ropivacaine in patients undergoing bariatric surgery is associated with a reduction in postoperative pain, lower morphine needs, earlier mobilization and earlier oral intake of fluids after surgery, and a shorter hospital stay.","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Cruz', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rivas', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain.'}, {'ForeName': 'Montiel', 'Initials': 'M', 'LastName': 'Jimenez', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrigni', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'University Hospital Rey Juan Carlos, Mostoles, Madrid, Spain.'}]",Obesity surgery,[]
846,26941086,Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.,"BACKGROUND


The combination of prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed in the pancreatic duct - and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP.
METHODS/DESIGN


The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked.
DISCUSSION


The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough.
TRIAL REGISTRATION


NCT02476279, registered June 2015.",2016,Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups.,"['patients undergoing high-risk ERCP', 'high-risk cases', 'One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention']","['rectal indomethacin and PSP', 'SVI (Stent vs. Indomethacin', 'indomethacin alone or combination therapy', 'Rectal indomethacin', 'indomethacin and prophylactic pancreatic stent placement', 'Indomethacin', 'prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed', 'PSP', 'rectal indomethacin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C2747855', 'cui_str': 'Pancreatic stent placement'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent (physical object)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]",[],1430.0,0.326371,Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups.,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA. SerranoJ@extra.niddk.nih.gov.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA. Amitabh.Chak@uhhospitals.org.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Edmundowicz', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA. SEdmundo@dom.wustl.edu.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Papachristou', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. papachri@pitt.edu.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Scheiman', 'Affiliation': 'Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA. jscheima@med.umich.edu.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA. vsingh1@jhmi.edu.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA. svaradarajulu@yahoo.com.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Vargo', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA. Vargoj@ccf.org.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA. field.willingham@emoryhealthcare.org.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. todd_baron@med.unc.edu.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. cotea@musc.edu.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Romagnuolo', 'Affiliation': 'Tidelands Health, Murrels Inlet, SC, USA. romagnuoloj@gmail.com.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Wood-Williams', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. woodap@musc.edu.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Depue', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. depue@musc.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. spitzer@musc.edu.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA. spino@med.umich.edu.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. fosterl@musc.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. durkalsv@musc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-016-1251-2']
847,32416926,[Effect of activities profile variations on health-related quality of life among breast cancer patients: Secondary exploratory analysis from PASAPAS study data].,"INTRODUCTION


Lifestyle changes in breast cancer patients, by physical activity increasing, are becoming a main objective in supportive care. The objective of this study was to explore the impact of the daily activity profile evolution on the quality of life among this public.
METHODS


Sixty patients (18 to 75 years) with non-metastatic breast cancer were randomized to a 2:1 ratio (physical activity intervention; control) in the PASAPAS randomized clinical trial. Multiple linear regression analyzes were computed to explain quality of life scores 6 months after the start of adjuvant therapy. Variables retained were the baseline quality of life scores, the anxiety trait, the randomization arm, the variations of time spent in different physical activity classes ([3-4 [MET, [4-6 [MET, ≥6 MET) and in sedentary behaviors.
RESULTS


Only the decrease in time spent in sedentary behaviors really appeared as a predictor of the quality of physical life. Participation in the intervention group appeared as a predictor of quality of mental life.
DISCUSSION


Results plead in favor of sedentary life style decrease as part of the objectives of care program for women with breast cancer. It also highlights the need of collective supervised sessions implemented by competent staff. This research also suggests that the dynamics of daily activity profile variations should be studied further in association to quality of life.",2020,"Participation in the intervention group appeared as a predictor of quality of mental life.
","['breast cancer patients', 'Sixty patients (18 to 75 years) with non-metastatic breast cancer', 'women with breast cancer']","['2:1 ratio (physical activity intervention; control', 'activities profile variations']","['quality of mental life', 'quality of physical life', 'baseline quality of life scores, the anxiety trait, the randomization arm, the variations of time spent in different physical activity classes', 'health-related quality of life', 'time spent in sedentary behaviors']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.041616,"Participation in the intervention group appeared as a predictor of quality of mental life.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Reynes', 'Affiliation': ""Université Lyon, université Claude-Bernard Lyon 1, laboratoire sur les vulnérabilités et l'innovation dans le sport (L-ViS, EA 7428), 69622 Lyon, France; UFR STAPS, 27-29, boulevard du 11 Novembre 1918, 69622 Villeurbanne cedex, France. Electronic address: eric.reynes@univ-lyon1.fr.""}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Berthouze', 'Affiliation': 'Université Lyon, université Claude-Bernard Lyon 1, laboratoire interuniversitaire de biologie de la motricité (LIBM, EA 7424), 69622 Lyon, France; UFR STAPS, 27-29, boulevard du 11 Novembre 1918, 69622 Villeurbanne cedex, France.'}, {'ForeName': 'Aude-Marie', 'Initials': 'AM', 'LastName': 'Foucaut', 'Affiliation': 'Université Sorbonne Paris Nord, laboratoire éducations et pratiques de santé (LEPS, UR 3412), Département STAPS, 74, rue Marcel-Cachin, 93017 Bobigny, France; Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Morelle', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Université de Lyon, GATE Lyon Saint-Étienne, UMR-CNRS 5824, 69007 Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bachmann', 'Affiliation': 'Centre Léon Bérard, unité de nutrition et diététique\xa0-\xa0DISSPO, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Kempf-Lépine', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre Léon Bérard, département cancer environnement, laboratoire «\xa0Santé, Individu, Société\xa0» EAM 4128, faculté de médecine Laënnec, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Meyrand', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Baudinet', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Carretier', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, laboratoire «\xa0Santé, Individu, Société\xa0» EAM 4128, faculté de médecine Laënnec, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': ""Centre Léon Bérard, département d'oncologie médicale, 28, rue Laennec, 69008 Lyon, France.""}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Fervers', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre de recherche en cancérologie de Lyon, UMR, Inserm 1052, CNRS 5286 CLB, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Touillaud', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre de recherche en cancérologie de Lyon, UMR, Inserm 1052, CNRS 5286 CLB, 28, rue Laennec, 69008 Lyon, France.'}]",Bulletin du cancer,['10.1016/j.bulcan.2020.03.014']
848,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS


Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS


Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
849,27125345,"Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants.","INTRODUCTION


This was the first study conducted to evaluate the efficacy of 2 oral doses of the human rotavirus vaccine, RIX4414 in Singaporean infants during the first 3 years of life.
MATERIALS AND METHODS


Healthy infants, 11 to 17 weeks of age were enrolled in this randomised (1:1), double-blinded, placebo-controlled study to receive 2 oral doses of RIX4414 vaccine/placebo following a 0-, 1-month schedule. Vaccine efficacy against severe rotavirus (RV) gastroenteritis (Vesikari score ≥11) caused by wild-type RV strains from a period starting from 2 weeks post-Dose 2 until 2 and 3 years of age was calculated with 95% confidence interval (CI). Immunogenicity and safety of the vaccine were also assessed.
RESULTS


Of 6542 infants enrolled, 6466 were included in the efficacy analysis and a subset of 100 infants was included in the immunogenicity analysis. Fewer severe RV gastroenteritis episodes were reported in the RIX4414 group when compared to placebo at both 2 and 3 year follow-up periods. Vaccine efficacy against severe RV gastroenteritis at the respective time points were 93.8% (95% CI, 59.9 to 99.9) and 95.2% (95% CI, 70.5 to 99.9). One to 2 months post-Dose 2 of RIX4414, 97.5% (95% CI, 86.8 to 99.9) of infants seroconverted for anti-RV IgA antibodies. The number of serious adverse events recorded from Dose 1 until 3 years of age was similar in both groups.
CONCLUSION


Two oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.",2016,"Two oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.","['6542 infants enrolled, 6466 were included in the efficacy analysis and a subset of 100 infants was included in the immunogenicity analysis', 'Healthy infants, 11 to 17 weeks of age', 'Singaporean Infants', 'Singaporean infants during the first 3 years of life', 'Singaporean children']","['RIX4414 vaccine/placebo', 'human rotavirus vaccine, RIX4414', 'placebo', 'RIX4414 vaccine', 'Human Rotavirus Vaccine RIX4414']","['Immunogenicity and safety', 'Vaccine efficacy against severe RV gastroenteritis', 'severe RV gastroenteritis episodes', 'Vaccine efficacy against severe rotavirus (RV) gastroenteritis (Vesikari score ≥11', 'number of serious adverse events', 'Efficacy, Immunogenicity and Safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1527844', 'cui_str': 'RIX4414 vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus (organism)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0343363', 'cui_str': 'Viral gastroenteritis due to Rotavirus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",6542.0,0.451577,"Two oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.","[{'ForeName': 'Kong Boo', 'Initials': 'KB', 'LastName': 'Phua', 'Affiliation': ""Department of Paediatrics, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Fong Seng', 'Initials': 'FS', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Seng Hock', 'Initials': 'SH', 'LastName': 'Quak', 'Affiliation': ''}, {'ForeName': 'Bee Wah', 'Initials': 'BW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Yee Leong', 'Initials': 'YL', 'LastName': 'Teoh', 'Affiliation': ''}, {'ForeName': 'Pemmaraju V', 'Initials': 'PV', 'LastName': 'Suryakiran', 'Affiliation': ''}, {'ForeName': 'Htay Htay', 'Initials': 'HH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Hans L', 'Initials': 'HL', 'LastName': 'Bock', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
850,26549852,Enhanced Psychosocial Support for Caregiver Burden for Patients With Chronic Kidney Failure Choosing Not to Be Treated by Dialysis or Transplantation: A Pilot Randomized Controlled Trial.,"BACKGROUND


Family caregivers of patients with chronic kidney failure have increased burden, as reflected by their high frequency of physical and mental disturbances. The impact of enhanced psychosocial support to caregivers of patients with chronic kidney failure remains unclear.
STUDY DESIGN


Open-label randomized controlled trial.
SETTING & PARTICIPANTS


All new patients referred to the renal palliative clinic were screened. Caregivers of patients who met the following criteria were recruited: (1) chronic kidney failure as defined by creatinine clearance < 15 mL/min, (2) opted for conservative management by nephrology team or patient, (3) never treated with dialysis or transplantation, and (4) able to provide informed consent.
INTERVENTIONS


Random assignment to treatment with enhanced psychosocial support or standard renal care (control). Enhanced psychosocial support included counseling and psychosocial interventions by an on-site palliative care nurse and designated social worker. Each caregiver was followed up at 2- to 4-week intervals for up to 6 months.
OUTCOMES


Zarit Burden Inventory (ZBI) and Hospital Anxiety and Depression Scale (HADS) in caregivers and McGill Quality of Life scores in patients of both groups were compared.
RESULTS


29 pairs of family caregivers/patients with chronic kidney failure were randomly assigned (intervention, n=14; control, n=15). Mean ages of patients and caregivers were 81.6 ± 5.1 and 59.8 ± 14.2 (SD) years, respectively. The intervention group showed significantly lower ZBI scores than the control group at 1 and 3 months (22.0 ± 5.3 vs 31.6 ± 9.5 and 21.3 ± 6.6 vs 33.4 ± 7.2; P=0.006 and P=0.009, respectively). HADS anxiety scores of caregivers who received the intervention were significantly lower than those of controls at 1 and 3 months (7.1 ± 3.2 vs 10.1 ± 2.2 and 6.5 ± 4.5 vs 11.0 ± 3.1; P=0.01 and P=0.03, respectively). Insignificant reductions in ZBI and HADS scores were found at 6 months. 19 patients died (intervention, n=10; control, n=9) during the study period.
LIMITATIONS


The study is limited by a relatively small sample size and short duration.
CONCLUSIONS


Enhanced psychosocial support program in patients with chronic kidney failure and caregivers resulted in an early significant reduction in caregiver burden and anxiety.",2016,"HADS anxiety scores of caregivers who received the intervention were significantly lower than those of controls at 1 and 3 months (7.1 ± 3.2 vs 10.1 ± 2.2 and 6.5 ± 4.5 vs 11.0 ± 3.1; P=0.01 and P=0.03, respectively).","['29 pairs of family caregivers/patients with chronic kidney failure', 'Caregivers of patients who met the following criteria were recruited: (1) chronic kidney failure as defined by creatinine clearance < 15 mL/min, (2) opted for conservative management by nephrology team or patient, (3) never treated with dialysis or transplantation, and (4) able to provide informed consent', 'patients with chronic kidney failure and caregivers', 'Patients', 'Family caregivers of patients with chronic kidney failure', 'caregivers of patients with chronic kidney failure', '19 patients died (intervention, n=10; control, n=9) during the study period', 'All new patients referred to the renal palliative clinic were screened', 'Mean ages of patients and caregivers were 81.6 ± 5.1 and 59.8 ± 14.2 (SD) years, respectively']","['Enhanced psychosocial support program', 'Dialysis or Transplantation', 'Random assignment to treatment with enhanced psychosocial support or standard renal care (control']","['Zarit Burden Inventory (ZBI) and Hospital Anxiety and Depression Scale (HADS) in caregivers and McGill Quality of Life scores', 'lower ZBI scores', 'HADS anxiety scores', 'ZBI and HADS scores', 'caregiver burden and anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1171215', 'cui_str': 'Renal care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.0442165,"HADS anxiety scores of caregivers who received the intervention were significantly lower than those of controls at 1 and 3 months (7.1 ± 3.2 vs 10.1 ± 2.2 and 6.5 ± 4.5 vs 11.0 ± 3.1; P=0.01 and P=0.03, respectively).","[{'ForeName': 'Kwok Ying', 'Initials': 'KY', 'LastName': 'Chan', 'Affiliation': 'Palliative Medical Unit, Grantham Hospital, Hong Kong. Electronic address: cky842@yahoo.com.hk.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Yip', 'Affiliation': 'Renal Unit, Tung Wah Hospital, Hong Kong.'}, {'ForeName': 'Desmond Y H', 'Initials': 'DY', 'LastName': 'Yap', 'Affiliation': 'Division of Nephrology, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Mau Kwong', 'Initials': 'MK', 'LastName': 'Sham', 'Affiliation': 'Palliative Medical Unit, Grantham Hospital, Hong Kong.'}, {'ForeName': 'Yim Chi', 'Initials': 'YC', 'LastName': 'Wong', 'Affiliation': 'Palliative Medical Unit, Grantham Hospital, Hong Kong.'}, {'ForeName': 'Vikki Wai Kee', 'Initials': 'VW', 'LastName': 'Lau', 'Affiliation': 'Palliative Medical Unit, Grantham Hospital, Hong Kong.'}, {'ForeName': 'Cho Wing', 'Initials': 'CW', 'LastName': 'Li', 'Affiliation': 'Palliative Medical Unit, Grantham Hospital, Hong Kong.'}, {'ForeName': 'Benjamin Hon Wai', 'Initials': 'BH', 'LastName': 'Cheng', 'Affiliation': 'Medical Palliative Medicine Team, Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Wai Kei', 'Initials': 'WK', 'LastName': 'Lo', 'Affiliation': 'Renal Unit, Tung Wah Hospital, Hong Kong.'}, {'ForeName': 'Tak Mao', 'Initials': 'TM', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2015.09.021']
851,27141543,Nitric oxide donors improve the ovulation and pregnancy rates in anovulatory women with polycystic ovary syndrome treated with clomiphene citrate: A RCT.,"BACKGROUND


Clomiphene citrate (CC) is the first line agent used for ovulation induction in patients with polycystic ovarian syndrome (PCOS). However, there is marked discrepancy between the ovulation and pregnancy rates achieved, which may be attributed to the undesirable effect of CC on cervical mucus and endometrium.
OBJECTIVE


The aim of this study was to evaluate the effect of Isosorbid monoitrate (ISMN) as nitric oxide (NO) donors on the ovulation and pregnancy rates in an ovulatory women with PCOS treated with CC.
MATERIALS AND METHODS


Ninety patients with PCOS were randomly allocated into three groups. Patients in group A) were treated with 100 mg CC for five days starting from the fifth day of the cycle. Patients in group B) and C) received 10 mg and 20 mg of ISMN respectively in addition to CC, applied vaginally till the diagnosis of ovulation.
RESULTS


There was a significant increase in the ovulation and pregnancy rates in the patients treated with CC+ISMN as compared with patients treated with CC alone (p< 0.001).
CONCLUSION


Concomitant use of NO with CC seems to improve the ovulation and pregnancy rates in the patients with PCOS with no significant increase in side effects as compared with CC alone.",2016,with CC seems to improve the ovulation and pregnancy rates in the patients with PCOS with no significant increase in side effects as compared with CC alone.,"['patients with polycystic ovarian syndrome (PCOS', 'ovulatory women with PCOS treated with CC', 'anovulatory women with polycystic ovary syndrome treated with', 'Ninety patients with PCOS']","['Nitric oxide donors', 'Clomiphene citrate (CC', 'ISMN', 'clomiphene citrate', 'Isosorbid monoitrate (ISMN']","['ovulation and pregnancy rates', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory (finding)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0600437', 'cui_str': 'Nitric Oxide Donors'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",90.0,0.0357526,with CC seems to improve the ovulation and pregnancy rates in the patients with PCOS with no significant increase in side effects as compared with CC alone.,"[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mahran', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abdelmeged', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Shawki', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Abdelrazek', 'Initials': 'A', 'LastName': 'Moheyelden', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Asmaa Mohamed', 'Initials': 'AM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Obstetrics and Gynecology, Beni-Mazar General hospital, Minia, Egypt.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
852,32418881,Pelvic Floor Muscle Training and Erectile Dysfunction in Radical Prostatectomy: A Randomized Controlled Trial Investigating a Non-Invasive Addition to Penile Rehabilitation.,"INTRODUCTION


Pelvic floor muscle (PFM) training for postprostatectomy incontinence is considered a first line approach to rehabilitation, but PFM training for erectile dysfunction (ED) after surgery is less well known. With more than 1.4 million new cases diagnosed globally per year, there is a need for non-invasive options to assist sexual dysfunction recovery.
AIM


Commencing preoperatively and using both fast and slow twitch fibre training performed in standing postures, new protocols were developed to address clinical presentations with aims to reduce ED and impact on quality of life (QoL). Comparisons with ""usual care"" PFM training, prerehabilitation and postrehabilitation were then assessed.
METHODS


A randomised controlled trial of 97 men undergoing radical prostatectomy (RP) were allocated to either a control group (n = 47) performing ""usual care"" of 3 sets/d PFMT or an intervention group (n = 50), performing 6 sets/d in standing, commencing 5 weeks before RP.
OUTCOME MEASURES


Participants were assessed preoperatively and at 2, 6, and 12 weeks after RP using the Expanded Prostate Cancer Index Composite for Clinical Practice, International Index of Erectile Function-5, and real time ultrasound measurements of PFM function.
RESULTS


At all time points, there was a significant difference (P< 0.05) between groups; however, the only time point where this difference was clinically relevant was at 2 weeks after RP, with the intervention group reporting less distress in the Expanded Prostate Cancer Index Composite for Clinical Practice QoL outcome. Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
CONCLUSIONS


Early PFM training reduces early QoL impact for postprostatectomy ED, with faster return to continence enabling earlier commencement of penile rehabilitation. While our 12-week protocol and sample size was not powerful enough to demonstrate conclusive benefits of early PFM training for ED, PFM intervention after RP over longer times has been supported by others. Milios JE, Ackland TR, Green DJ. Pelvic Floor Muscle Training and Erectile Dysfunction in Radical Prostatectomy: A Randomized Controlled Trial Investigating a Non-Invasive Addition to Penile Rehabilitation. J Sex Med 2020;8:414-421.",2020,"Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
","['97 men undergoing', 'Radical Prostatectomy']","['Pelvic floor muscle (PFM) training', 'PFM training', 'radical prostatectomy (RP', 'Pelvic Floor Muscle Training', 'Penile Rehabilitation', 'control group (n\xa0= 47) performing ""usual care"" of 3 sets/d PFMT or an intervention group']","['EPIC-EF and real time ultrasound PFM function tests', 'bothersome scores', 'quality of life (QoL']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",97.0,0.077007,"Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
","[{'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Milios', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia. Electronic address: jomilios22@gmail.com.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Ackland', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia.'}]",Sexual medicine,['10.1016/j.esxm.2020.03.005']
853,31560051,Effectiveness of Oral Vancomycin for Prevention of Healthcare Facility-Onset Clostridioides difficile Infection in Targeted Patients During Systemic Antibiotic Exposure.,"BACKGROUND


Limited retrospective data suggest prophylactic oral vancomycin may prevent Clostridioides difficile infection (CDI). We sought to evaluate the effectiveness of oral vancomycin for the prevention of healthcare facility-onset CDI (HCFO-CDI) in targeted patients.
METHODS


We conducted a randomized, prospective, open-label study at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina, between October 2018 and April 2019. Included patients were randomized 1:1 to either oral vancomycin (dosed at 125 mg once daily while receiving systemic antibiotics and continued for 5 days postcompletion of systemic antibiotics [OVP]) or no prophylaxis. The primary endpoint was incidence of HCFO-CDI. Secondary endpoints included incidence of community-onset healthcare facility-associated CDI (CO-HCFA-CDI), incidence of vancomycin-resistant Enterococci (VRE) colonization after receiving OVP, adverse effects, and cost of OVP.
RESULTS


A total of 100 patients were evaluated, 50 patients in each arm. Baseline and hospitalization characteristics were similar, except antibiotic exposure. No events of HCFO-CDI were noted in the OVP group compared with 6 (12%) in the no-prophylaxis group (P = .03). CO-HCFA-CDI was identified in 2 patients who were previously diagnosed with HCFO-CDI. No patients developed new VRE colonization, with only 1 patient reporting mild gastrointestinal side effects to OVP. A total of 600 doses of OVP were given during the study, with each patient receiving an average of 12 doses. Total acquisition cost of OVP was $1302, $26.04 per patient.
CONCLUSION


OVP appears to protect against HCFO-CDI during in-patient stay in targeted patients during systemic antibiotic exposure. Further prospective investigation is warranted.",2020,No events of HCFO-CDI were noted in the OVP group compared to 6 (12%) in the no prophylaxis group (p = 0.03).,"['Novant Health Forsyth Medical Center in Winston-Salem, North Carolina between October 2018 and April 2019', 'targeted patients', 'A total of 100 patients were evaluated, 50 patients in each arm', '2 patients who were previously diagnosed with HCFO-CDI', 'Targeted Patients']","['OVP', 'vancomycin', 'Oral Vancomycin', 'oral vancomycin', 'systemic antibiotics [OVP]), or no prophylaxis']","['new VRE colonization', 'HCFO-CDI', 'Baseline and hospitalization characteristics', 'incidence of HCFO-CDI', 'Total acquisition cost of OVP', 'incidence of community-onset healthcare facility-associated CDI (CO-HCFA-CDI), incidence of vancomycin-resistant Enterococci (VRE) colonization after receiving OVP, adverse effects and cost of OVP', 'CO-HCFA-CDI']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0041718', 'cui_str': 'Health Care Financing Administration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",100.0,0.103606,No events of HCFO-CDI were noted in the OVP group compared to 6 (12%) in the no prophylaxis group (p = 0.03).,"[{'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina, USA.'}, {'ForeName': 'Shannon V', 'Initials': 'SV', 'LastName': 'Brown', 'Affiliation': 'Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Priest', 'Affiliation': 'Novant Health Institute for Safety and Quality, Winston-Salem, North Carolina, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz966']
854,27231129,Mosaic Loss of Chromosome Y in Blood Is Associated with Alzheimer Disease.,"Men have a shorter life expectancy compared with women but the underlying factor(s) are not clear. Late-onset, sporadic Alzheimer disease (AD) is a common and lethal neurodegenerative disorder and many germline inherited variants have been found to influence the risk of developing AD. Our previous results show that a fundamentally different genetic variant, i.e., lifetime-acquired loss of chromosome Y (LOY) in blood cells, is associated with all-cause mortality and an increased risk of non-hematological tumors and that LOY could be induced by tobacco smoking. We tested here a hypothesis that men with LOY are more susceptible to AD and show that LOY is associated with AD in three independent studies of different types. In a case-control study, males with AD diagnosis had higher degree of LOY mosaicism (adjusted odds ratio = 2.80, p = 0.0184, AD events = 606). Furthermore, in two prospective studies, men with LOY at blood sampling had greater risk for incident AD diagnosis during follow-up time (hazard ratio [HR] = 6.80, 95% confidence interval [95% CI] = 2.16-21.43, AD events = 140, p = 0.0011). Thus, LOY in blood is associated with risks of both AD and cancer, suggesting a role of LOY in blood cells on disease processes in other tissues, possibly via defective immunosurveillance. As a male-specific risk factor, LOY might explain why males on average live shorter lives than females.",2016,"In a case-control study, males with AD diagnosis had higher degree of LOY mosaicism (adjusted odds ratio = 2.80, p = 0.0184, AD events = 606).",['men with LOY'],[],"['life expectancy', 'incident AD diagnosis', 'degree of LOY mosaicism']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0026578', 'cui_str': 'Mosaicism'}]",,0.0979372,"In a case-control study, males with AD diagnosis had higher degree of LOY mosaicism (adjusted odds ratio = 2.80, p = 0.0184, AD events = 606).","[{'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Dumanski', 'Affiliation': 'Department of Immunology, Genetics, and Pathology, Uppsala University, 75108\xa0Uppsala, Sweden; Science for Life Laboratory, Uppsala University, 75123\xa0Uppsala, Sweden. Electronic address: jan.dumanski@igp.uu.se.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Lambert', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1167 - RID-AGE - Risk Factors and Molecular Determinants of Aging-Related Diseases, 59000 Lille, France.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rasi', 'Affiliation': 'Department of Immunology, Genetics, and Pathology, Uppsala University, 75108\xa0Uppsala, Sweden; Science for Life Laboratory, Uppsala University, 75123\xa0Uppsala, Sweden.'}, {'ForeName': 'Vilmantas', 'Initials': 'V', 'LastName': 'Giedraitis', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, 75185\xa0Uppsala, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Davies', 'Affiliation': 'Department of Immunology, Genetics, and Pathology, Uppsala University, 75108\xa0Uppsala, Sweden; Science for Life Laboratory, Uppsala University, 75123\xa0Uppsala, Sweden.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Grenier-Boley', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1167 - RID-AGE - Risk Factors and Molecular Determinants of Aging-Related Diseases, 59000 Lille, France.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Lindgren', 'Affiliation': 'Wellcome Trust Centre for Human Genetics, University of Oxford, OX3 7BN Oxford, UK; Broad Institute of MIT and Harvard University, Cambridge, MA 02142, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Campion', 'Affiliation': 'CNR-MAJ, Inserm, U1079, Rouen University Hospital, Rouen 76031 France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dufouil', 'Affiliation': 'Inserm, U708, Victor Segalen University, Bordeaux 33076, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Pasquier', 'Affiliation': 'Université de Lille, CNR-MAJ, Inserm 1171, Distalz, Lille 59000, France; CHU, Lille 59000, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Amouyel', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1167 - RID-AGE - Risk Factors and Molecular Determinants of Aging-Related Diseases, 59000 Lille, France.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lannfelt', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, 75185\xa0Uppsala, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ingelsson', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, 75185\xa0Uppsala, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Kilander', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, 75185\xa0Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Medical Sciences, Uppsala University, 75185\xa0Uppsala, Sweden.'}, {'ForeName': 'Lars A', 'Initials': 'LA', 'LastName': 'Forsberg', 'Affiliation': 'Department of Immunology, Genetics, and Pathology, Uppsala University, 75108\xa0Uppsala, Sweden; Science for Life Laboratory, Uppsala University, 75123\xa0Uppsala, Sweden. Electronic address: lars.forsberg@igp.uu.se.'}]",American journal of human genetics,['10.1016/j.ajhg.2016.05.014']
855,30592241,Bros Will Be Bros? The Effect of Fraternity Membership on Perceived Culpability for Sexual Assault.,"To examine the link between fraternity membership and sexual assault perpetration, we used an experimental design to assess the role of perceptions in an ambiguous sexual assault scenario. Undergraduates ( N  = 408) were randomly assigned to either an experimental group where the perpetrator is a fraternity member or a control group where no fraternity information is given. Males rated perpetrators as less guilty and victims as more culpable when the perpetrator was a fraternity member, suggesting that sexual violence may be reinforced among fraternity members as they are both more likely to perpetrate sexual assault and less likely to be blamed.",2019,"Males rated perpetrators as less guilty and victims as more culpable when the perpetrator was a fraternity member, suggesting that sexual violence may be reinforced among fraternity members as they are both more likely to perpetrate sexual assault and less likely to be blamed.",['Undergraduates ( N = 408'],['Fraternity Membership'],[],"[{'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}]",[],[],408.0,0.0207466,"Males rated perpetrators as less guilty and victims as more culpable when the perpetrator was a fraternity member, suggesting that sexual violence may be reinforced among fraternity members as they are both more likely to perpetrate sexual assault and less likely to be blamed.","[{'ForeName': 'Rita C', 'Initials': 'RC', 'LastName': 'Seabrook', 'Affiliation': '1 Rutgers University, New Brunswick, NJ, USA.'}, {'ForeName': 'L Monique', 'Initials': 'LM', 'LastName': 'Ward', 'Affiliation': '2 University of Michigan, Ann Arbor, USA.'}]",Violence against women,['10.1177/1077801218820196']
856,26426576,"Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study.","BACKGROUND


We recently described a lateral-to-medial approach for transversus abdominis plane (LM-TAP) block, which may permit preoperative initiation of the block.
OBJECTIVE


Our objective was to evaluate the feasibility of continuous LM-TAP blocks in clinical practice in comparison with thoracic epidural analgesia (TEA).
DESIGN


A randomised, open-label study.
SETTING


University Hospital, London Health Sciences Centre, London, Ontario, Canada from July 2008 to August 2012.
PATIENTS


Fifty adult patients undergoing open abdominal surgery via laparotomy were allocated randomly to receive preoperative catheter-congruent TEA or ultrasound-guided continuous bilateral LM-TAP block for 72 h postoperatively. Reasons for noninclusion were American Society of Anesthesiologists' physical status more than 4, known allergy to study drugs, chronic pain/opioid dependence, spinal abnormalities or psychiatric illness.
INTERVENTIONS


In the TEA group (n = 24), patient-controlled epidural analgesia was maintained using bupivacaine 0.1% with hydromorphone 10 μg ml⁻¹ after establishment of the initial block. In the LM-TAP group (n = 26), ultrasound-guided LM-TAP catheters were inserted on each side preoperatively after a bolus of 30 ml of ropivacaine 0.5% (20 ml subcostal and 10 ml subumbilical injections on both sides). Analgesia was maintained with an infusion of ropivacaine 0.35% at a rate of 2 to 2.5 ml h⁻¹ through each catheter, along with rescue intravenous patient-controlled analgesia.
MAIN OUTCOME MEASURES


The primary outcome was pain score on coughing 24 h after the end of surgery. Secondary outcomes were pain scores from 24 to 72 h, intraoperative and postoperative opioid consumption, time to onset of bowel movement and side effect profiles.
RESULTS


Mean [95% confidence interval (95% CI)] pain scores at rest ranged from 1. 7 (0.9 to 2.5) to 2.3 (1.1 to 3.4) in TEA vs. 1.5 (0.7 to 2.2) to 2.2 (1.3 to 3.0) in LM-TAP (P = 0.829). The dynamic pain scores ranged from 2.9 (1.5 to 4.4) to 3.8 (2.8 to 4.8) in TEA vs. 3.3 (2.4 to 4.3) to 3.8 (2.7 to 4.9) in LM-TAP (P = 0.551). The variability in pain scores was lower in the LM-TAP group than in the TEA group in the first 24 h postoperatively. Patient satisfaction and other secondary outcomes were similar.
CONCLUSION


Continuous bilateral LM-TAP block can be initiated preoperatively and may provide comparable analgesia to TEA in patients undergoing laparotomy.
CLINICAL TRIALS REGISTRY


not registered because registration was not mandatory at the time of starting the trial.",2015,The variability in pain scores was lower in the LM-TAP group than in the TEA group in the first 24 h postoperatively.,"['patients undergoing laparotomy', 'University Hospital, London Health Sciences Centre, London, Ontario, Canada from July 2008 to August 2012', 'Fifty adult patients undergoing open abdominal surgery via laparotomy', 'patients undergoing abdominal surgery']","['TEA', 'continuous LM-TAP blocks', 'lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia', 'bupivacaine', 'hydromorphone', 'LM-TAP', 'ropivacaine', 'preoperative catheter-congruent TEA or ultrasound-guided continuous bilateral LM-TAP block']","['dynamic pain scores', 'variability in pain scores', 'Mean', 'pain scores', 'pain score on coughing 24\u200ah', 'pain scores from 24 to 72\u200ah, intraoperative and postoperative opioid consumption, time to onset of bowel movement and side effect profiles', 'Analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",50.0,0.250912,The variability in pain scores was lower in the LM-TAP group than in the TEA group in the first 24 h postoperatively.,"[{'ForeName': 'Sugantha', 'Initials': 'S', 'LastName': 'Ganapathy', 'Affiliation': 'From the Department of Anesthesia and Perioperative Medicine, London Health Sciences Centre, Western University, London, Ontario, Canada.'}, {'ForeName': 'Rakesh V', 'Initials': 'RV', 'LastName': 'Sondekoppam', 'Affiliation': ''}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Terlecki', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Brookes', 'Affiliation': ''}, {'ForeName': 'Sanjib', 'Initials': 'S', 'LastName': 'Das Adhikary', 'Affiliation': ''}, {'ForeName': 'Lakshmimathy', 'Initials': 'L', 'LastName': 'Subramanian', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000000345']
857,31562797,Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.,"BACKGROUND


Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial.
METHODS


We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group.
RESULTS


At a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63). Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group. No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone. No new late toxic effects were noted.
CONCLUSIONS


Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505.).",2019,No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone.,"['Advanced Melanoma', 'patients with advanced melanoma']","['Combined Nivolumab and Ipilimumab', 'ipilimumab-matched placebo; or ipilimumab', 'nivolumab-matched placebo', 'nivolumab-plus-ipilimumab', 'ipilimumab', 'nivolumab']","['Overall survival', 'longer progression-free and overall survival', 'quality of life', 'new late toxic effects', 'median overall survival', 'sustained long-term overall survival', 'progression-free survival and overall survival', 'sustained deterioration of health-related quality of life']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.538325,No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Lao', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'C Lance', 'Initials': 'CL', 'LastName': 'Cowey', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Pier F', 'Initials': 'PF', 'LastName': 'Ferrucci', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hogg', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Márquez-Rodas', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Guidoboni', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'McArthur', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Daniels', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Rizzo', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Balogh', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Andriy', 'Initials': 'A', 'LastName': 'Moshyk', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa1910836']
858,32065601,Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial.,"Importance


Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited.
Objective


To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD.
Design, Setting, and Participants


The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019.
Interventions


In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%).
Main Outcomes and Measures


The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs.
Results


Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, -1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar.
Conclusions and Relevance


Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure.
Trial Registration


Netherlands Trial Register Identifier: NTR3764.",2020,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"['6 hospitals in the Netherlands in which 523 patients with stage 3 CKD', '262 patients', 'patients with stage', 'The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women', 'patients with stage 3 CKD', 'patients with stage 3 chronic kidney disease (CKD', 'Adults With Chronic Kidney Disease', '554 patients randomized', 'Data were analyzed from January 2018 to June 2019']","['prehydration', 'no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate', 'omitting prophylactic prehydration prior to iodine-based contrast media administration', 'Contrast-Enhanced Computed Tomography', 'No Prehydration vs Sodium Bicarbonate Prehydration']","['incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs', 'Postcontrast acute kidney injury', 'Mean hydration costs', 'serum creatinine level', 'mean (SD) relative increase in creatinine level', 'renal safety', 'safe and cost-efficient measure', 'acute heart failure']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",262.0,0.201305,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"[{'ForeName': 'Rohit J', 'Initials': 'RJ', 'LastName': 'Timal', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kooiman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yvo W J', 'Initials': 'YWJ', 'LastName': 'Sijpkens', 'Affiliation': 'Department of Internal Medicine, Haaglanden Medisch Centrum Bronovo, The Hague, the Netherlands.'}, {'ForeName': 'Jean-Paul P M', 'Initials': 'JPM', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Iris J A M', 'Initials': 'IJAM', 'LastName': 'Verberk-Jonkers', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Harald F H', 'Initials': 'HFH', 'LastName': 'Brulez', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'van Buren', 'Affiliation': 'Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'van der Molen', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Cannegieter', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ton J', 'Initials': 'TJ', 'LastName': 'Rabelink', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.7428']
859,31829912,Sequencing of Androgen-Deprivation Therapy With External-Beam Radiotherapy in Localized Prostate Cancer: A Phase III Randomized Controlled Trial.,"PURPOSE


Dose-escalated radiotherapy (RT) with androgen-deprivation therapy (ADT) is a standard definitive treatment of localized prostate cancer (LPCa). The optimal sequencing of these therapies is unclear. Our phase III trial compared neoadjuvant versus concurrent initiation of ADT in combination with dose-escalated prostate RT (PRT).
PATIENTS AND METHODS


Patients with newly diagnosed LPCa with Gleason score ≤ 7, clinical stage T1b to T3a, and prostate-specific antigen < 30 ng/mL were randomly allocated to neoadjuvant and concurrent ADT for 6 months starting 4 months before RT (neoadjuvant group) or concurrent and adjuvant ADT for 6 months starting simultaneously with RT (concurrent group). The primary end point was biochemical relapse-free survival (bRFS). Stratified log-rank test was used to compare bRFS and overall survival (OS). Incidence of grade ≥ 3 late RT-related toxicities was compared by log-rank test.
RESULTS


Overall, 432 patients were randomly assigned to the neoadjuvant (n = 215) or concurrent group (n = 217). At 10 years, bRFS rates for the two groups were 80.5% and 87.4%, respectively. Ten-year OS rates were 76.4% and 73.7%, respectively. There was no significant difference in bRFS ( P  = .10) or OS ( P  = .70) between the two groups. Relative to the neoadjuvant group, the hazard ratio for the concurrent group was 0.66 (95% CI, 0.41 to 1.07) for bRFS and 0.94 (95% CI, 0.68 to 1.30) for OS. No significant difference was observed in the 3-year incidence of late RT-related grade ≥ 3 GI (2.5%  v  3.9%) or genitourinary toxicity (2.9%  v  2.9%).
CONCLUSION


In our study, there was no statistically significant difference in bRFS between the two treatment groups. Similarly, no difference was seen in OS or late RT-related toxicities. On the basis of these results, both neoadjuvant and concurrent initiations of short-term ADT with dose-escalated PRT are reasonable standards of care for LPCa.",2020,There was no significant difference in bRFS ( P  = .10) or OS ( P  = .70) between the two groups.,"['Patients with newly diagnosed LPCa with Gleason score ≤ 7, clinical stage T1b to T3a, and prostate-specific antigen', 'localized prostate cancer (LPCa', 'Localized Prostate Cancer', '432 patients were randomly assigned to the neoadjuvant (n = 215) or concurrent group (n = 217']","['ADT', 'radiotherapy (RT) with androgen-deprivation therapy (ADT', 'Androgen-Deprivation Therapy With External-Beam Radiotherapy', 'RT (neoadjuvant group) or concurrent and adjuvant ADT', 'neoadjuvant and concurrent ADT']","['Incidence of grade ≥ 3 late RT-related toxicities', '3-year incidence of late RT-related grade ≥ 3 GI', 'bRFS', 'OS or late RT-related toxicities', 'bRFS and overall survival (OS', 'biochemical relapse-free survival (bRFS', 'bRFS rates', 'genitourinary toxicity', 'hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1136355', 'cui_str': 'BRFSS'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",432.0,0.0881589,There was no significant difference in bRFS ( P  = .10) or OS ( P  = .70) between the two groups.,"[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Choan', 'Initials': 'C', 'LastName': 'E', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'MacRae', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Perry', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bowen', 'Affiliation': 'Northeast Cancer Centre, Sudbury, Ontario, Canada.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Samant', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01904']
860,25788230,"CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial.","BACKGROUND


The benefit of CT coronary angiography (CTCA) in patients presenting with stable chest pain has not been systematically studied. We aimed to assess the effect of CTCA on the diagnosis, management, and outcome of patients referred to the cardiology clinic with suspected angina due to coronary heart disease.
METHODS


In this prospective open-label, parallel-group, multicentre trial, we recruited patients aged 18-75 years referred for the assessment of suspected angina due to coronary heart disease from 12 cardiology chest pain clinics across Scotland. We randomly assigned (1:1) participants to standard care plus CTCA or standard care alone. Randomisation was done with a web-based service to ensure allocation concealment. The primary endpoint was certainty of the diagnosis of angina secondary to coronary heart disease at 6 weeks. All analyses were intention to treat, and patients were analysed in the group they were allocated to, irrespective of compliance with scanning. This study is registered with ClinicalTrials.gov, number NCT01149590.
FINDINGS


Between Nov 18, 2010, and Sept 24, 2014, we randomly assigned 4146 (42%) of 9849 patients who had been referred for assessment of suspected angina due to coronary heart disease. 47% of participants had a baseline clinic diagnosis of coronary heart disease and 36% had angina due to coronary heart disease. At 6 weeks, CTCA reclassified the diagnosis of coronary heart disease in 558 (27%) patients and the diagnosis of angina due to coronary heart disease in 481 (23%) patients (standard care 22 [1%] and 23 [1%]; p<0·0001). Although both the certainty (relative risk [RR] 2·56, 95% CI 2·33-2·79; p<0·0001) and frequency of coronary heart disease increased (1·09, 1·02-1·17; p=0·0172), the certainty increased (1·79, 1·62-1·96; p<0·0001) and frequency seemed to decrease (0·93, 0·85-1·02; p=0·1289) for the diagnosis of angina due to coronary heart disease. This changed planned investigations (15% vs 1%; p<0·0001) and treatments (23% vs 5%; p<0·0001) but did not affect 6-week symptom severity or subsequent admittances to hospital for chest pain. After 1·7 years, CTCA was associated with a 38% reduction in fatal and non-fatal myocardial infarction (26 vs 42, HR 0·62, 95% CI 0·38-1·01; p=0·0527), but this was not significant.
INTERPRETATION


In patients with suspected angina due to coronary heart disease, CTCA clarifies the diagnosis, enables targeting of interventions, and might reduce the future risk of myocardial infarction.
FUNDING


The Chief Scientist Office of the Scottish Government Health and Social Care Directorates funded the trial with supplementary awards from Edinburgh and Lothian's Health Foundation Trust and the Heart Diseases Research Fund.",2015,"After 1·7 years, CTCA was associated with a 38% reduction in fatal and non-fatal myocardial infarction (26 vs 42, HR 0·62, 95% CI 0·38-1·01; p=0·0527), but this was not significant.
","['patients with suspected angina due to coronary heart disease', 'patients with suspected angina due to coronary heart disease (SCOT-HEART', '47% of participants had a baseline clinic diagnosis of coronary heart disease and 36% had angina due to coronary heart disease', 'patients presenting with stable chest pain', 'patients aged 18-75 years referred for the assessment of suspected angina due to coronary heart disease from 12 cardiology chest pain clinics across Scotland', 'patients referred to the cardiology clinic with suspected angina due to coronary heart disease', 'Between Nov 18, 2010, and Sept 24, 2014, we randomly assigned 4146 (42%) of 9849 patients who had been referred for assessment of suspected angina due to coronary heart disease']","['CT coronary angiography', 'CT coronary angiography (CTCA', 'CTCA', 'standard care plus CTCA or standard care alone']","['certainty of the diagnosis of angina secondary to coronary heart disease', 'fatal and non-fatal myocardial infarction', 'frequency of coronary heart disease', 'CTCA reclassified the diagnosis of coronary heart disease', 'diagnosis of angina due to coronary heart disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205542', 'cui_str': 'Reclassified (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]",9849.0,0.093102,"After 1·7 years, CTCA was associated with a 38% reduction in fatal and non-fatal myocardial infarction (26 vs 42, HR 0·62, 95% CI 0·38-1·01; p=0·0527), but this was not significant.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(15)60291-4']
861,25434622,"A Double-Blind, Randomised, Placebo-Controlled Trial of EMLA® Cream (Eutectic Lidocaine/Prilocaine Cream) for Analgesia Prior to Cryotherapy of Plantar Warts in Adults.","INTRODUCTION


Cryotherapy with liquid nitrogen is an effective, safe and convenient form of treatment for plantar warts. EMLA® cream (eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is a topical local anaesthetic agent that has proven to be effective and well tolerated in the relief of pain associated with various minor interventions in numerous clinical settings.
MATERIALS AND METHODS


In a single-centre, double-blind, randomised placebo-controlled study, 64 subjects were randomised into 2 groups. The subjects had a thick layer of EMLA® cream or placebo cream applied to pared plantar wart(s) and onto the surrounding margin of 1 mm to 2 mm under occlusion for 60 minutes prior to receiving cryotherapy. The pain of cryotherapy was evaluated by the subjects using a self-administered Visual Analogue Scale (VAS) immediately after the cryotherapy.
RESULTS


There was no statistical difference between the mean VAS score for EMLA® cream (47.0 ± 21.4 mm) and placebo (48.9 ± 22.0 mm). Those with more than 1 wart had a significantly higher VAS score than those with only 1 wart (59.1 ± 21.8 vs. 44.3 ± 20.4, P <0.05) but this did not affect the therapeutic effect of EMLA® cream prior to cryotherapy.
CONCLUSION


We conclude that the application of EMLA® cream prior to cryotherapy does not reduce the pain associated with cryotherapy.",2014,We conclude that the application of EMLA® cream prior to cryotherapy does not reduce the pain associated with cryotherapy.,"['64 subjects', 'Plantar Warts in Adults']","['cryotherapy', 'EMLA® cream', 'placebo', 'Cryotherapy with liquid nitrogen', 'Placebo', 'EMLA® cream (eutectic mixture of lidocaine', 'EMLA® cream or placebo cream', 'prilocaine', 'EMLA® Cream (Eutectic Lidocaine/Prilocaine Cream']","['VAS score', 'mean VAS score', 'pain', 'pain of cryotherapy']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen (substance)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine / Prilocaine'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",64.0,0.0882629,We conclude that the application of EMLA® cream prior to cryotherapy does not reduce the pain associated with cryotherapy.,"[{'ForeName': 'Siew Hui', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Clinical Nursing Unit, National University Hospital, Singapore.'}, {'ForeName': 'Janthorn', 'Initials': 'J', 'LastName': 'Pakdeethai', 'Affiliation': ''}, {'ForeName': 'Matthias P H S', 'Initials': 'MP', 'LastName': 'Toh', 'Affiliation': ''}, {'ForeName': 'Derrick C W', 'Initials': 'DC', 'LastName': 'Aw', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
862,25792897,Functional Changes in the Care-needing Elderly after Surface Electrical Stimulation to the Abdomen.,"BACKGROUND


Strength of the trunk muscles is a key component of motor control, but it declines easily with the process of aging and/or disuse.
OBJECTIVES


To investigate the effects of surface electrical stimulation (ES) to the abdominal muscles and the motor performance for care-needing elderly.
DESIGN


Controlled trial.
PARTICIPANTS


Twenty-one elderly people (60-90 years) with care-needing, who were admitted to a nursing home or hospital for daily care and their score of Barthel Index had been stable from 55.3 ± 19.4 to 55.3 ± 19.8 during 3 months before intervention.
INTERVENTION


Common physical/occupational therapy was performed for all of the subjects during the study period. ES was applied to the abdomen of 15 subjects (ES group) twice a day for 8 weeks.
MEASUREMENTS


Functional measurements were performed before and after beginning of the study with some parameters as follows: grip strength; movement time for sitting up (MSU); maximum walking speed (WS).
RESULTS


No significant differences between two groups were noted for characteristics at baseline. In the ES group, MSU (from 21.1 ± 21.4 to 10.4 ± 8.3 sec) significantly improved (p < 0.05) after 8weeks. WS (from 17.7 ± 12.1 to 24.3 ± 15.3 m/min) were also improved (p < 0.05) after 8 weeks.
LIMITATIONS


A limitation of this study was the small sample size.
CONCLUSIONS


ES to the abdominal area has the potential to improve motor function in the care-needing elderly through reinforcement of the abdominal muscles.",2012,No significant differences between two groups were noted for characteristics at baseline.,"['care-needing elderly', 'Twenty-one elderly people (60-90 years) with care-needing, who were admitted to a nursing home or hospital for daily care and their score of Barthel Index had been stable from 55.3 ± 19.4 to 55.3 ± 19.8 during 3 months before intervention']","['Common physical/occupational therapy', 'surface electrical stimulation (ES']","['motor function', 'grip strength; movement time for sitting up (MSU); maximum walking speed (WS']","[{'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0560837', 'cui_str': 'Does sit up (finding)'}]",21.0,0.0129204,No significant differences between two groups were noted for characteristics at baseline.,"[{'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Miura', 'Affiliation': 'Department of Internal Medicine and Rehabilitation, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Seki', 'Affiliation': 'Sendai School of Health and Welfare, Sendai, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ito', 'Affiliation': 'Department of Internal Medicine and Rehabilitation, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Handa', 'Affiliation': 'Division of Developmental Neuroscience, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kohzuki', 'Affiliation': 'Department of Internal Medicine and Rehabilitation, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",Journal of the Japanese Physical Therapy Association = Rigaku ryoho,['10.1298/jjpta.Vol15_002']
863,25447301,"The effects of energy balance, obesity-proneness and sex on the neuronal response to sweet taste.","We have previously shown that propensity for weight gain, energy balance state and sex are important determinants of the neuronal response to visual food cues. It is not clear, though, whether these factors also impact the neuronal response to taste. The objective of this study was to examine the neuronal response to sweet taste during energy imbalance in men and women recruited to be obesity-prone (OP) or obesity-resistant (OR). OP (13 men and 12 women) and OR (12 men and 12 women) subjects were studied after 1 day of eucaloric, overfed and underfed conditions in a randomized crossover design. On each test day, fMRI was performed in the respective acute fed state while subjects received in random order 60 trials each of 1M sucrose solution (SU), or artificial saliva (AS) following a visual cue predicting the taste. The neuronal response to SU versus AS expectation was significantly greater in the amygdala, orbitofrontal cortex, putamen and insula in OR versus OP; SU receipt was not different between groups. There were also sex-based differences with men having greater neuronal response to SU versus AS receipt in the caudate than women. The results, however, were not impacted by the state of energy balance. In summary, response to expectation but not receipt of basic sweet taste was different in OR compared to OP, highlighting the importance of learning and conditioning in the propensity to gain weight. Response to sucrose taste receipt was stronger in men than women, raising questions about the effect of sex hormones on brain response to food.",2015,"Response to sucrose taste receipt was stronger in men than women, raising questions about the effect of sex hormones on brain response to food.","['OP (13 men and 12 women) and OR (12 men and 12 women) subjects', 'men and women recruited to be obesity-prone (OP) or obesity-resistant (OR']","['1M sucrose solution (SU), or artificial saliva (AS) following a visual cue predicting the taste']",['neuronal response to SU versus AS expectation'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva (product)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}]","[{'cui': 'C0679138', 'cui_str': 'Expectations'}]",,0.0443906,"Response to sucrose taste receipt was stronger in men than women, raising questions about the effect of sex hormones on brain response to food.","[{'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. Electronic address: marc.cornier@ucdenver.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Shott', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thomas', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Bechtell', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Tregellas', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; Department of Neuroscience, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; Research Service, VA Medical Center, Denver, CO, USA.'}, {'ForeName': 'Guido K', 'Initials': 'GK', 'LastName': 'Frank', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA; Department of Neuroscience, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.'}]",Behavioural brain research,['10.1016/j.bbr.2014.10.024']
864,31420895,Feasibility of sedation on demand in Taiwan using water exchange and air insufflation: A randomized controlled trial.,"BACKGROUND AND AIM


Completion of colonoscopy without sedation eliminates sedation cost and complications. Reported in the United States and Europe, on-demand sedation is not routine practice in Taiwan. Water exchange (WE), characterized by infusion and nearly complete removal of infused water during insertion, reduces insertion pain compared to air insufflation (AI) during colonoscopy. We evaluated the feasibility of on-demand sedation in Taiwan. In a randomized controlled trial of WE vs AI colonoscopy, we also aimed to determine if WE augmented the implementation by reducing insertion pain and decreasing sedation requirement.
METHODS


This prospective patient-blinded study randomized patients to AI or WE (75 patients/group) to aid insertion. The primary outcome was the proportion of patients completing without sedation.
RESULTS


In the AI and WE groups, 76.0% and 93.3% (P = 0.006) completed without need for sedation, respectively. The WE group had lower insertion pain score (mean [SD]) (4.0 [2.9] vs 2.1 [2.6], P < 0.001), lower doses of propofol (25.7 [52.7] mg vs 9.1 [35.6] mg, P = 0.012), and less time in the recovery room (3.4 [7.4] vs 1.5 [5.5], P = 0.027) than the AI group. Patient satisfaction scores and willingness to repeat if needed in the future were similar.
CONCLUSION


On-demand sedation was feasible in Taiwan. The completion rate without sedation was high in patients (76.0% with standard AI) open to the option (no prior intent to receive the standard of full or minimal sedation). WE augmented the implementation by reducing insertion pain and decreasing sedation requirement without adversely affecting patient satisfaction or willingness to repeat.",2020,"In the AI and WE groups, 76.0% and 93.3% (P=0.006) completed without need for sedation, respectively.","['Taiwan', 'Taiwan using water exchange and air insufflation']",['AI colonoscopy'],"['proportion of patients completing without sedation', 'completion rate without sedation', 'lower insertion pain score [mean (SD']","[{'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",75.0,0.143706,"In the AI and WE groups, 76.0% and 93.3% (P=0.006) completed without need for sedation, respectively.","[{'ForeName': 'Yu-Hsi', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tseng', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Koo', 'Affiliation': 'Graduate Institute of Long-term Care, Tzu Chi University of Science and Technology, Hualien, Taiwan.'}, {'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Leung', 'Affiliation': 'Veterans Affairs Greater Los Angeles Healthcare System, Sepulveda Ambulatory Care Center, North Hill, California, USA.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14839']
865,25882235,An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids.,"INTRODUCTION


Incidental reports collected in clinical trials suggest that amongst participants, omega-3 fatty acids derived from fish oil ('omega-3') may be difficult to blind.
MATERIALS AND METHODS


We conducted a systematic evaluation of blinding success in a 24-week trial of omega-3 versus an oil-based placebo. Within 1 week of supplement commencement (Week 1), a blinding questionnaire was completed by 131 children enrolled in a trial of omega-3 for the treatment of disruptive behaviour disorders. A version of the questionnaire was also completed by their parents at Week 1, and by the children at the end of supplement administration (Week 24).
RESULTS


Participants were unable to differentiate omega-3 from placebo, and accuracy did not improve as a function of: the confidence of guesses, reason for guesses, notice of any change, beliefs about what should change, or time. Child and parent guesses also showed high concordance.
CONCLUSION


Taken together, these data provide strong evidence that the identity of omega-3 can be blinded to participants.",2015,"RESULTS


Participants were unable to differentiate omega-3 from placebo, and accuracy did not improve as a function of: the confidence of guesses, reason for guesses, notice of any change, beliefs about what should change, or time.",['131 children enrolled in a trial of omega-3 for the treatment of disruptive behaviour disorders'],"['omega-3 versus an oil-based placebo', 'fish oil omega-3 fatty acids', ""omega-3 fatty acids derived from fish oil ('omega-3""]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012734', 'cui_str': 'Disruptive Behavior Disorder'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]",[],131.0,0.138483,"RESULTS


Participants were unable to differentiate omega-3 from placebo, and accuracy did not improve as a function of: the confidence of guesses, reason for guesses, notice of any change, beliefs about what should change, or time.","[{'ForeName': 'Jean C J', 'Initials': 'JC', 'LastName': 'Liu', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, Singapore.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Raine', 'Affiliation': ''}, {'ForeName': 'Rebecca P', 'Initials': 'RP', 'LastName': 'Ang', 'Affiliation': ''}, {'ForeName': 'Daniel S S', 'Initials': 'DS', 'LastName': 'Fung', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
866,25767441,Propensity to obesity impacts the neuronal response to energy imbalance.,"The mechanisms responsible for the propensity to gain weight or remain normal weight are poorly understood. The objective of this study was to study the neuronal response to visual food cues during short-term energy imbalance in healthy adults recruited as obesity-resistant (OR) or obesity-prone (OP) based on self-identification, body mass index, and personal/family weight history. Twenty-five OR and 28 OP subjects were studied in underfed (UF) and overfed (OF) as compared to eucaloric (EU) conditions in a randomized crossover design. Each study phase included a 3-day run-in diet, 1 day of controlled feeding (basal energy needs for EU, 40% above/below basal energy needs for OF/UF), and a test day. On the test day, fMRI was performed in the acute fed stated (30 min after a test meal) while subjects viewed images of foods of high hedonic value and neutral non-food objects. Measures of appetite and hormones were also performed before and every 30 min after the test meal. UF was associated with significantly increased activation of insula, somatosensory cortex, inferior and medial prefrontal cortex (PFC), parahippocampus, precuneus, cingulate, and visual cortex in OR. However, UF had no impact in OP. As a result, UF was associated with significantly greater activation, specifically in the insula, inferior PFC, and somatosensory cortex in OR as compared to OP. While OF was overall associated with reduced activation of inferior visual cortex, no group interaction was observed with OF. In summary, these findings suggest that individuals resistant to weight gain and obesity are more sensitive to short-term energy imbalance, particularly with UF, than those prone to weight gain. The inability to sense or adapt to changes in energy balance may represent an important mechanism contributing to excess energy intake and risk for obesity.",2015,"UF was associated with significantly increased activation of insula, somatosensory cortex, inferior and medial prefrontal cortex (PFC), parahippocampus, precuneus, cingulate, and visual cortex in OR.","['healthy adults recruited as obesity-resistant (OR) or obesity-prone (OP) based on self-identification, body mass index, and personal/family weight history', 'Twenty-five OR and 28 OP subjects']",[],"['reduced activation of inferior visual cortex', 'activation of insula, somatosensory cortex, inferior and medial prefrontal cortex (PFC), parahippocampus, precuneus, cingulate, and visual cortex in OR', 'appetite and hormones', 'OP']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C3715062', 'cui_str': '25'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]",,0.0291288,"UF was associated with significantly increased activation of insula, somatosensory cortex, inferior and medial prefrontal cortex (PFC), parahippocampus, precuneus, cingulate, and visual cortex in OR.","[{'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, Anschutz Medical Campus, University of Colorado School of Medicine , Aurora, CO , USA ; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus , Aurora, CO , USA.'}, {'ForeName': 'Kristina L', 'Initials': 'KL', 'LastName': 'McFadden', 'Affiliation': 'Department of Psychiatry, Anschutz Medical Campus, University of Colorado School of Medicine , Aurora, CO , USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thomas', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, Anschutz Medical Campus, University of Colorado School of Medicine , Aurora, CO , USA ; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus , Aurora, CO , USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Bechtell', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, Anschutz Medical Campus, University of Colorado School of Medicine , Aurora, CO , USA ; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus , Aurora, CO , USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, Anschutz Medical Campus, University of Colorado School of Medicine , Aurora, CO , USA ; Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus , Aurora, CO , USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Tregellas', 'Affiliation': 'Department of Psychiatry, Anschutz Medical Campus, University of Colorado School of Medicine , Aurora, CO , USA ; Department of Neuroscience, Anschutz Medical Campus, University of Colorado School of Medicine , Aurora, CO , USA ; Research Service, VA Medical Center , Denver, CO , USA.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2015.00052']
867,25588917,Overcoming Barriers to Mammography Screening: A Quasi-randomised Pragmatic Trial in a Community-based Primary Care Setting.,"INTRODUCTION


Breast cancer is the leading cancer among women in Singapore. Five years after a population-wide breast cancer screening programme was introduced, screening rates remained relatively low at 41%. Studies have shown decreased screening propensity among medically underserved women typically of minority or socioeconomically disadvantaged status. We conducted a quasi-randomised pragmatic trial aimed at encouraging mammography screening among underscreened or unscreened women in a publicly funded primary care facility in Singapore.
MATERIALS AND METHODS


The study was conducted from May to August 2010. Components of intervention included (1) tailored education, (2) doctor's reminder, and (3) cost reduction. Researchers administered a structured questionnaire to eligible female polyclinic attendees and patient companions aged 40 to 69 years. Individual knowledge, attitudes, beliefs, and barriers towards mammography screening were identified and educational messages tailored. Doctor's reminder and cost reduction were implemented additively.
RESULTS


Overall, out of 448 participants, 87 (19.4%, 95% confidence interval (CI), 15.8% to 23.1%) completed mammography screening across 3 arms of study. Participants who received a cost reduction were more likely to attend screening compared to participants in other intervention arms (adjusted odds ratio (OR) 2.4, 95% CI, 1.2 to 4.5, P = 0.009). Cost of screening, ethnicity, prior screening history, and attitudes towards mammography screening were identified as significant factors predicting mammogram attendance.
CONCLUSION


Including a cost reduction component was the most effective intervention that increased mammography screening rates. Women's underlying beliefs, attitudes, and other predisposing factors should also be considered for integration into existing breast cancer screening programmes.",2014,"Participants who received a cost reduction were more likely to attend screening compared to participants in other intervention arms (adjusted odds ratio (OR) 2.4, 95% CI, 1.2 to 4.5, P = 0.009).","['eligible female polyclinic attendees and patient companions aged 40 to 69 years', 'underscreened or unscreened women in a publicly funded primary care facility in Singapore', 'medically underserved women typically of minority or socioeconomically disadvantaged status', 'women in Singapore']",['mammography screening'],"['mammography screening', 'mammography screening rates', 'Cost of screening, ethnicity, prior screening history, and attitudes towards mammography screening', 'Individual knowledge, attitudes, beliefs, and barriers towards mammography screening']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",448.0,0.0388338,"Participants who received a cost reduction were more likely to attend screening compared to participants in other intervention arms (adjusted odds ratio (OR) 2.4, 95% CI, 1.2 to 4.5, P = 0.009).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Seetoh', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Wei Fong', 'Initials': 'WF', 'LastName': 'Siew', 'Affiliation': ''}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': ''}, {'ForeName': 'Wei Fong', 'Initials': 'WF', 'LastName': 'Liau', 'Affiliation': ''}, {'ForeName': 'Gerald C H', 'Initials': 'GC', 'LastName': 'Koh', 'Affiliation': ''}, {'ForeName': 'Jeannette J M', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Mee Lian', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Seow', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
868,31993658,A Pilot Randomized Controlled Trial of Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women.,"INTRODUCTION


The majority of women who smoke cigarettes report that concern about weight gain is a barrier to quitting. We developed an intervention incorporating distress tolerance, appetite awareness, and mindful eating skills to target concerns about post-cessation weight gain and emotional eating (DT-W). In the current study, we conducted a pilot randomized controlled trial of DT-W versus a smoking health education (HE) intervention.
METHODS


Participants (N = 69 adult female, weight-concerned smokers) were recruited in cohorts of 4-11. Cohorts were randomized to DT-W or HE. DT-W and HE were matched on format (single individual session followed by eight group sessions), inclusion of cognitive behavioral therapy for smoking cessation (CBT) content, and pharmacotherapy (nicotine patches). Follow-up assessments occurred at 1-, 3-, and 6-months post-treatment.
RESULTS


The recruitment goal was met; 61 of the 69 participants attended at least one group session. There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE) (ps > .05), but comprehension ratings were lower in DT-W than in HE (p = .02).
CONCLUSIONS


Overall, these results suggest that the study procedures and interventions were feasible and acceptable, but changes to the DT-W intervention content to improve comprehension should be considered prior to conducting a fully powered trial.
IMPLICATIONS


A distress tolerance-based treatment targeting fear of weight gain after smoking cessation and post-cessation emotional eating was feasible and acceptable relative to a smoking HE comparison condition, but changes should be considered before conducting a larger trial. Continued innovation in treatment development for weight-concerned smokers is needed.",2020,"There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE)","['Smoking Cessation Among Women', 'Participants (N = 69 adult female, weight-concerned smokers']","['Distress Tolerance Treatment', 'DT-W vs. a smoking health education (HE) intervention', 'cognitive-behavioral therapy for smoking cessation (CBT) content, and pharmacotherapy (nicotine patches']","['DT-W and HE', 'distress tolerance, appetite awareness, and mindful eating skills to target concerns about post-cessation weight gain and emotional eating (DT-W', 'ratings of treatment effectiveness or usefulness of skills, or retention', 'comprehension ratings']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0971308', 'cui_str': 'DT-W(IV)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0018701'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0971308', 'cui_str': 'DT-W(IV)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",69.0,0.0749398,"There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE)","[{'ForeName': 'Erika Litvin', 'Initials': 'EL', 'LastName': 'Bloom', 'Affiliation': 'Departments of Psychiatry and Human Behavior and Medicine, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ramsey', 'Affiliation': 'Departments of Psychiatry and Human Behavior and Medicine, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Abrantes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hunt', 'Affiliation': 'Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Molino', 'Affiliation': 'Department of Orthopaedics, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'University of Texas at Austin School of Nursing, Austin, TX.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa026']
869,32427115,Mobile App to Improve House Officers' Adherence to Advanced Cardiac Life Support Guidelines: Quality Improvement Study.,"BACKGROUND


Effective and timely delivery of cardiac arrest interventions during in-hospital cardiac arrest resuscitation is associated with greater survival. Whether a mobile app that provides timely reminders of critical interventions improves adherence to Advanced Cardiovascular Life Support (ACLS) guidelines among house officers, who may lack experience in leading resuscitations, remains unknown.
OBJECTIVE


The aim of this study was to assess the impact of a commercially available, dynamic mobile app on house officers' adherence to ACLS guidelines.
METHODS


As part of a quality improvement initiative, internal medicine house officers were invited to participate and randomized to lead 2 consecutive cardiac arrest simulations, one with a novel mobile app and one without a novel mobile app. All simulations included 4 cycles of cardiopulmonary resuscitation with different cardiac arrest rhythms and were video recorded. The coprimary end points were chest compression fraction and number of correct interventions in each simulation. The secondary end point was incorrect interventions, defined as interventions not indicated by the 2015 ACLS guidelines. Paired t tests compared performance with and without the mobile app.
RESULTS


Among 53 house officers, 26 house officers were randomized to lead the first simulation with the mobile app, and 27 house officers were randomized to do so without the app. Use of the mobile app was associated with a higher number of correct ACLS interventions (out of 7; mean 6.2 vs 5.1; absolute difference 1.1 [95% CI 0.6 to 1.6]; P<.001) as well as fewer incorrect ACLS interventions (mean 0.3 vs 1.0; absolute difference -0.7 [95% CI -0.3 to -1.0]; P<.001). Simulations with the mobile app also had a marginally higher chest compression fraction (mean 90.9% vs 89.0%; absolute difference 1.9% [95% CI 0.6% to 3.4%]; P=.007).
CONCLUSIONS


This proof-of-concept study suggests that this novel mobile app may improve adherence to ACLS protocols, but its effectiveness on survival in real-world resuscitations remains unknown.",2020,"RESULTS


Among 53 house officers","['53 house officers', '26 house officers were randomized to lead the first simulation with the mobile app, and 27 house officers']",['novel mobile app and one without a novel mobile app'],"['higher number of correct ACLS interventions', 'chest compression fraction', 'incorrect ACLS interventions', 'chest compression fraction and number of correct interventions']","[{'cui': 'C0401975', 'cui_str': 'House officer'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.123049,"RESULTS


Among 53 house officers","[{'ForeName': 'Vittal', 'Initials': 'V', 'LastName': 'Hejjaji', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Ali O', 'Initials': 'AO', 'LastName': 'Malik', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Poghni A', 'Initials': 'PA', 'LastName': 'Peri-Okonny', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Merrill', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wooldridge', 'Affiliation': 'Department of Internal Medicine, University of Missouri Kansas City, Kansas City, MO, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Chan', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}]",JMIR mHealth and uHealth,['10.2196/15762']
870,24356654,Integrated care pathway for hip fractures in a subacute rehabilitation setting.,"INTRODUCTION


The effectiveness of integrated care pathways for hip fractures in subacute rehabilitation settings is not known. The study objective was to assess if a hip fracture integrated care pathway at a subacute rehabilitation facility would result in better functional outcomes, shorter length of stay and fewer institutionalisations.
MATERIALS AND METHODS


A randomised controlled trial on an integrated care pathway for hip fracture patients in a subacute rehabilitation setting. Modified Barthel Index, ambulatory status, SF-12, length of stay, discharge destination, hospital readmission and mortality were measured. Followup assessments were up to 1 year post-hip fracture.
RESULTS


There were no significant differences in Montebello Rehabilitation Factor Scores and proportions achieving premorbid ambulatory status at discharge, 6 months and 12 months respectively. There was a significant reduction in the median length of stay between the control group at 48.0 days and the intervention group at 35.0 days (P = 0.009). The proportion of readmissions to acute hospitals was similar in both groups up to 1 year. There were no significant differences for nursing home stay up to 1 year post-discharge and mortality at 1 year.
CONCLUSION


Our study supports the use of integrated care pathways in subacute rehabilitation settings to reduce length of stay whilst achieving the same functional gains.",2013,"There were no significant differences in Montebello Rehabilitation Factor Scores and proportions achieving premorbid ambulatory status at discharge, 6 months and 12 months respectively.",['hip fracture patients in a subacute rehabilitation setting'],[],"['functional outcomes, shorter length of stay and fewer institutionalisations', 'Modified Barthel Index, ambulatory status, SF-12, length of stay, discharge destination, hospital readmission and mortality', 'nursing home stay', 'median length of stay', 'proportion of readmissions to acute hospitals', 'Montebello Rehabilitation Factor Scores and proportions achieving premorbid ambulatory status']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0238733,"There were no significant differences in Montebello Rehabilitation Factor Scores and proportions achieving premorbid ambulatory status at discharge, 6 months and 12 months respectively.","[{'ForeName': 'Tsung Wei', 'Initials': 'TW', 'LastName': 'Chong', 'Affiliation': ""Medical Division, St Luke's Hospital, Singapore.""}, {'ForeName': 'Gribson', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Goh', 'Affiliation': ''}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Hew', 'Affiliation': ''}, {'ForeName': 'Tze Pin', 'Initials': 'TP', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Boon Yeow', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
871,23804546,"Antiobesity effect of Gynostemma pentaphyllum extract (actiponin): a randomized, double-blind, placebo-controlled trial.","OBJECTIVE


The effects of actiponin was investigated, a heat-processed Gynostemma pentaphyllum extract, on body weight, fat loss, and metabolic markers of Korean participants in a 12-week, randomized, double-blind, placebo-controlled clinical trial.
DESIGN AND METHODS


Obese participants (BMI ≥ 25 kg m(-2) and WHR ≥ 0.90 for male or WHR ≥ 0.85 for female) who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 80 subjects were randomly divided into actiponin (n = 40, 450 mg day(-1) ) and placebo (n = 40) groups. Outcomes included measurement of efficacy (abdominal fat distribution, anthropometric parameters, and blood lipid profiles) and safety (adverse events, laboratory test results, electrocardiogram data, and vital signs).
RESULTS


During 12-week of actiponin supplementation, total abdominal fat area, body weight, body fat mass, percent body fat, and BMI were significantly decreased (P = 0.044, P < 0.05, P < 0.0001, P < 0.0001, and P < 0.05, respectively) in the actiponin group compared to the placebo group. No clinically significant changes in any safety parameter were observed.
CONCLUSION


Our study revealed that actiponin is a potent antiobesity reagent that does not produce any significant adverse effects. These results suggest that actiponin supplementation may be effective for treating obese individuals.",2014,"No clinically significant changes in any safety parameter were observed.
","['80 subjects', 'Obese participants (BMI\u2009≥\u200925 kg m(-2) and WHR\u2009≥\u20090.90 for male or WHR\u2009≥\u20090.85 for female) who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study']","['actiponin supplementation', 'placebo', 'Gynostemma pentaphyllum extract (actiponin', 'actiponin']","['body weight, fat loss, and metabolic markers', 'safety parameter', 'measurement of efficacy (abdominal fat distribution, anthropometric parameters, and blood lipid profiles) and safety (adverse events, laboratory test results, electrocardiogram data, and vital signs', 'total abdominal fat area, body weight, body fat mass, percent body fat, and BMI']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517483', 'cui_str': '0.85 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3886709', 'cui_str': 'actiponin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0950016', 'cui_str': 'Gynostemma pentaphyllum'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker (substance)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test result'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0518766'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",80.0,0.605816,"No clinically significant changes in any safety parameter were observed.
","[{'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Food Science and Human Nutrition, Obesity Research Center, Chonbuk National University, Jeonju, Republic of Korea; Department of Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Tae-Lin', 'Initials': 'TL', 'LastName': 'Huh', 'Affiliation': ''}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Mi-Ra', 'Initials': 'MR', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Tirupathi Pichiah', 'Affiliation': ''}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': ''}, {'ForeName': 'Youn-Soo', 'Initials': 'YS', 'LastName': 'Cha', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.20539']
872,32066431,Influence of the implant-abutment connection on the ratio between height and thickness of tissues at the buccal zenith: a randomized controlled trial on 188 implants placed in 104 patients.,"BACKGROUND


To compare tissue response to two implant systems, featuring internal hexed connections with different designs.
METHODS


Patients enrolled in this randomized controlled trial were assigned to two groups. In Group 1, patients were treated with implants with a 5° conical internal hexed connection (Anyridge®, MegaGen, South Korea). In Group 2, patients were treated with implants with an internal hexed connection (Core®, Kristal, Italy). After implant placement and a provisionalisation period of 12 months, impressions were taken, stone casts were poured and digitised with a desktop scanner (D700®, 3Shape, Copenhagen, Denmark). In a digital environment, for each fixture, two values were collected at the buccal zenith: the height of the peri-implant mucosa (mucosal height; MH), calculated from the vestibular shoulder of the implant analogue to the upper gingival margin of the supra-implant tissue; and the width of the peri-implant mucosa (mucosal thickness; MT), calculated from the vestibular shoulder of the analogue to the external mucosa point perpendicular to the implant major axis. The mean and standard deviation for MH and MT, as well as their ratios, were calculated for each group; the sectors in which the implants were placed were also considered. Finally, correlation between MH, MT, connection type and sector was assessed by Pearson's correlation coefficient, with significance level set at 0.05, and a confidence interval (CI) set at 95%.
RESULTS


Data deriving from 188 implants placed in 104 patients were evaluated. The mean MH values were 3.32 (± 0.12) and 2.70 (± 0.16) mm for Groups 1 and 2, respectively. The mean MT values were 4.37 (± 0.16) and 3.93 (± 0.18) mm for Groups 1 and 2, respectively. Group 1 showed higher MH and MT values and a better ratio (1.50 ± 0.88) than Group 2 (1.81 ± 1.20). The MH, MT and MH/MT ratio were significantly influenced both by sector (p = 0.015) and group (p = 0.047).
CONCLUSIONS


Within the limits of this study, the 5° connection implants supported a more extended tissue height and thickness at the buccal zenith, and a better ratio between them.
TRIAL REGISTRATION


This study was retrospectively registered in Clinicaltrials.gov, with number NCT04160689, dated 13/11/2019.",2020,"The MH, MT and MH/MT ratio were significantly influenced both by sector (p = 0.015) and group (p = 0.047).
","['188 implants placed in 104 patients', 'Data deriving from 188 implants placed in 104 patients were evaluated', 'Patients enrolled']","['implant-abutment connection', 'implants with a 5° conical internal hexed connection (Anyridge®, MegaGen, South Korea']","['MH and MT values', 'MH, MT and MH/MT ratio', 'mean MH values', 'MH, MT, connection type and sector', 'mean MT values']","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",104.0,0.0614897,"The MH, MT and MH/MT ratio were significantly influenced both by sector (p = 0.015) and group (p = 0.047).
","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Farronato', 'Affiliation': 'Department of Medicine and Surgery, School of Dentistry, University of Insubria, Varese, Italy. davide@farronato.it.'}, {'ForeName': 'Pietro Mario', 'Initials': 'PM', 'LastName': 'Pasini', 'Affiliation': 'Department of Medicine and Surgery, School of Dentistry, University of Insubria, Varese, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Manfredini', 'Affiliation': 'Private Practice, corso Europa 10, 20122, Milan, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Scognamiglio', 'Affiliation': 'Private Practice, corso della Vittoria 744, 21042 Caronno Pertusella, Varese, Italy.'}, {'ForeName': 'Andrea Alain', 'Initials': 'AA', 'LastName': 'Orsina', 'Affiliation': 'Department of Medicine and Surgery, School of Dentistry, University of Insubria, Varese, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Farronato', 'Affiliation': 'Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Department of Orthodontics, School of Dentistry, Milan, Italy.'}]",BMC oral health,['10.1186/s12903-020-1037-5']
873,32096902,"A Head-to-Head Comparison of Percutaneous Mastoid Electrical Stimulator and Supraorbital Transcutaneous Stimulator in the Prevention of Migraine: A Prospective, Randomized Controlled Study.","INTRODUCTION


This prospective, randomized, multicenter head-to-head outcome study was performed to compare the efficacy and safety of Percutaneous Mastoid Electrical Stimulator (PMES) and Supraorbital Transcutaneous Stimulator (STS) in migraine prevention.
METHODS


This was a prospective, randomized, head-to-head outcome study that involved three medical centers. After a one-month run-in, episodic patients with at least two migraine attacks/month were randomized to receive PMES daily for 45 min or STS daily for 20 min for three months. The primary outcomes were change in monthly migraine days and the 50% response rate.
RESULTS


A total of 90 patients were included in this study. We observed statistically significant reduction of migraine days in the third month treatment both in the PMES group and STS group. The difference between the two groups was not significant (60.5% vs. 53.8%, p = 0.88). Of note, 77.8% patients in the PMES group and 62.2% patients in the STS group had a ≥50% reduction of migraine days in the third month (p = 0.070). The change in monthly migraine days, monthly migraine attacks, severity of migraine days, accompanying symptoms during migraine and monthly acute anti-migraine drug intake were not significantly different between the two groups. The change of Headache Impact Test-6 (HIT-6) from run-in to the third-month treatment in the STS group was more remarkable than that in the PMES group (36.5% vs. 25.6%, p = 0.041). The occurrence of discomfort paresthesia was higher in the STS group (13.3% vs. 0%, p = 0.026).
CONCLUSION


PMES and STS treatment were both effective in migraine prevention. The safety and efficacy of PMES and STS were comparable.",2020,"The occurrence of discomfort paresthesia was higher in the STS group (13.3% vs. 0%, p = 0.026).
","['episodic patients with at least two migraine attacks/month', 'Migraine', 'A total of 90 patients were included in this study']","['PMES daily for 45\u2009min or STS', 'Percutaneous Mastoid Electrical Stimulator and Supraorbital Transcutaneous Stimulator', 'Percutaneous Mastoid Electrical Stimulator (PMES) and Supraorbital Transcutaneous Stimulator (STS', 'PMES', 'PMES and STS']","['safety and efficacy of PMES and STS', 'efficacy and safety', 'change of Headache Impact Test-6 (HIT-6', 'occurrence of discomfort paresthesia', 'change in monthly migraine days and the 50% response rate', 'change in monthly migraine days, monthly migraine attacks, severity of migraine days, accompanying symptoms during migraine and monthly acute anti-migraine drug intake', 'migraine days']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0446908', 'cui_str': 'Mastoid Bone'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",90.0,0.0344102,"The occurrence of discomfort paresthesia was higher in the STS group (13.3% vs. 0%, p = 0.026).
","[{'ForeName': 'Yushuang', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': ""School of Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Lanying', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': ""Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, People's Republic of China.""}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13127']
874,23417588,"Electrocardiograph changes, troponin levels and cardiac complications after orthopaedic surgery.","INTRODUCTION


The relationship between electrocardiograph (ECG) changes and troponin levels after the emergency orthopaedic surgery are not well characterised. The aim of this study was to determine the correlation between ECG changes (ischaemia or arrhythmia), troponin elevations perioperatively and cardiac complications.
MATERIALS AND METHODS


One hundred and eighty-seven orthopaedic patients over 60 years of age were prospectively tested for troponin I and ECGs were performed on the fi rst 3 postoperative mornings or until discharge.
RESULTS


The incidences of pre- and postoperative troponin elevation were 15.5% and 37.4% respectively, the majority were asymptomatically detected. Most of the patients who sustained a troponin rise did not have any concomitant ECG changes (51/70 or 72.9%). Postoperative ECG changes were noted in 18.4% (34/185) and of those with ECG changes, slightly more than half (55.9%) had a troponin elevation. Most ECG changes occurred on postoperative day 1 and were non-ST elevation in type. ECG changes occurred more frequently with higher troponin levels. Postoperative troponin elevation (P = 0.018) and not preoperative troponin level (P = 0.060) was associated with ECG changes on univariate analysis. Two premorbid factors were predictors of postoperative ECG changes using multivariate logistical regression; age [odds ratio (OR), 1.05; 95% CI, 1.005 to 1.100, P = 0.029) and sex OR, 2.4; 95% CI, 1.069 to 5.446, P = 0.034). Twenty patients sustained postoperative cardiac complications; 9 (45%) were associated with ECG changes and 16 (80%) with postoperative troponin elevation. Pre- or postoperative troponin elevation better predicted cardiac complications compared with preoperative ECG changes.
CONCLUSION


Electrocardiograph changes do not necessarily accompany troponin elevations after the emergency orthopaedic surgery but are more likely to have higher troponin levels. The best predictor of postoperative cardiac complications is troponin elevation.",2013,Postoperative troponin elevation (P = 0.018) and not preoperative troponin level (P = 0.060) was associated with ECG changes on univariate analysis.,['One hundred and eighty-seven orthopaedic patients over 60 years of age'],"['troponin', 'Electrocardiograph']","['troponin elevation', 'incidences of pre- and postoperative troponin elevation', 'Electrocardiograph changes, troponin levels and cardiac complications', 'Postoperative ECG changes', 'ECG changes (ischaemia or arrhythmia), troponin elevations perioperatively and cardiac complications', 'Postoperative troponin elevation', 'postoperative cardiac complications', 'postoperative troponin elevation', 'ECG changes', 'preoperative troponin level', 'electrocardiograph (ECG) changes and troponin levels', 'concomitant ECG changes']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0180600', 'cui_str': 'Electrocardiograph'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0180600', 'cui_str': 'Electrocardiograph'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0428966', 'cui_str': 'Postoperative ECG changes'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0340276', 'cui_str': 'Postoperative cardiac complication (disorder)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]",187.0,0.184903,Postoperative troponin elevation (P = 0.018) and not preoperative troponin level (P = 0.060) was associated with ECG changes on univariate analysis.,"[{'ForeName': 'Carol P', 'Initials': 'CP', 'LastName': 'Chong', 'Affiliation': 'Department of Aged Care, The Northern Hospital, Epping, Victoria, Australia. carol.chong@nh.org.au'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'van Gaal', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Profitis', 'Affiliation': ''}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Savige', 'Affiliation': ''}, {'ForeName': 'Wen Kwang', 'Initials': 'WK', 'LastName': 'Lim', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
875,32426888,Preschoolers exhibit greater on-task behavior following physically active lessons on the approximate number system.,"OBJECTIVE


To determine how the dual-task nature of incorporating physical activity with instructional activities immediately impacts acuity of the approximate number system and on-task behavior in preschoolers.
METHODS


Using a randomized within-participants repeated-measures crossover design, 51 children completed an approximate number system task before and after either 20-min of physically active instruction corresponding to 38% heart rate reserve (HRR; light-to-moderate intensity) or conventional sedentary instruction at corresponding to 21% HRR (very light intensity).
RESULTS


Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction. Overall, preschoolers accrued 931.3 ± 8.2 more steps and an additional 9 minutes at or above light-intensity activity during the physically active instruction.
CONCLUSION


Accordingly, these findings suggest that the dual-task nature of physically active learning does not compromise learning, reduces the need for redirecting off-task behavior, and ultimately allows children to avoid sedentary behavior in educational contexts.",2020,"RESULTS


Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction.","['preschoolers', '51 children completed an']",['approximate number system task before and after either 20-min of physically active instruction corresponding to 38% heart rate reserve (light-to-moderate intensity) or conventional sedentary instruction at corresponding to 21% heart rate reserve (very light intensity'],['task behavior'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439538', 'cui_str': 'Very light'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",51.0,0.058158,"RESULTS


Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'McGowan', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ferguson', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Hope K', 'Initials': 'HK', 'LastName': 'Gerde', 'Affiliation': 'Human Development and Family Studies, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Pontifex', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13727']
876,31996186,Lactoferrin infant feeding trial_Canada (LIFT_Canada): protocol for a randomized trial of adding lactoferrin to feeds of very-low-birth-weight preterm infants.,"BACKGROUND


In Canada alone, almost 3000 VLBW infants are born and treated annually with almost 1200 going onto death or survival with severe brain injury, chronic lung disorders, aggressive retinopathy of prematurity, late-onset sepsis, or significant necrotizing enterocolitis. Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying, bifidogenic glycoprotein found in all vertebrates and in mammalian milk, leukocytes and exocrine secretions. Lactoferrin aids in creating an environment for growth of beneficial bacteria in the gut, thus reducing colonization with pathogenic bacteria. It is hypothesized that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight preterm infants.
METHOD


Lactoferrin Infant Feeding Trial_Canada (LIFT_Canada) is a multi-centre, double-masked, randomized controlled trial with the aim to enroll 500 infants whose data will be combined with the data of the 1542 infants enrolled from Lactoferrin Infant Feeding Trial_Australia/New Zealand (LIFT_ANZ) in a pooled intention-to-treat analysis. Eligible infants will be randomized and allocated to one of two treatment groups: 1) a daily dose of 200 mg/kg bLF in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier; 2) no bLF with daily feeds. The primary outcome will be determined at 36 weeks corrected gestation for the presence of neonatal morbidity and at discharge for survival and treated retinopathy of prematurity. The duration of the trial is expected to be 36 months.
DISCUSSION


Currently, there continues to be no clear answer related to the benefit of bLF in reducing mortality or any or all of the significant neonatal morbidities in very low birth weight infants. LIFT_Canada is designed with the hope that the pooled results from Australia, New Zealand, and Canada may help to clarify the situation.
TRIAL REGISTRATION


Clinical Trials.Gov, Identifier: NCT03367013, Registered December 8, 2017.",2020,"Lactoferrin aids in creating an environment for growth of beneficial bacteria in the gut, thus reducing colonization with pathogenic bacteria.","['very low birth weight preterm infants', 'very low birth weight infants', '3000 VLBW infants are born and treated annually with almost 1200 going onto death or survival with severe brain injury, chronic lung disorders', 'enroll 500 infants whose data will be combined with the data of the 1542 infants enrolled from', 'Eligible infants', 'very-low-birth-weight preterm infants']","['Lactoferrin Infant Feeding Trial_Australia/New Zealand (LIFT_ANZ', 'Lactoferrin', 'Lactoferrin aids', 'Lactoferrin Infant Feeding Trial_Canada (LIFT_Canada', 'LIFT_Canada', 'bLF', 'lactoferrin', 'daily dose of 200\u2009mg/kg bLF in breast/donor human milk or formula milk until 34\u2009weeks corrected gestation or for a minimum of 2\u2009weeks, whichever is longer, or until discharge home or transfer, if earlier; 2) no bLF with daily feeds', 'oral bovine lactoferrin (bLF', 'Lactoferrin infant feeding trial_Canada (LIFT_Canada']",['neonatal morbidity and at discharge for survival and treated retinopathy of prematurity'],"[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0452742', 'cui_str': 'Formula milk (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1440867', 'cui_str': 'lactoferrin, bovine'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}]",1542.0,0.400141,"Lactoferrin aids in creating an environment for growth of beneficial bacteria in the gut, thus reducing colonization with pathogenic bacteria.","[{'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Asztalos', 'Affiliation': 'Department of Newborn and Developmental Paediatrics, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, M4-230, 2075 Bayview Ave., Toronto, ON, M4N 3M5, Canada. elizabeth.asztalos@sunnybrook.ca.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barrington', 'Affiliation': 'Department of Pediatrics, Université de Montréal, Montréal, PQ, Canada.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.'}]",BMC pediatrics,['10.1186/s12887-020-1938-0']
877,32427114,Use of the Healthy Lifestyle Coaching Chatbot App to Promote Stair-Climbing Habits Among Office Workers: Exploratory Randomized Controlled Trial.,"BACKGROUND


Lack of time for exercise is common among office workers given their busy lives. Because of occupational restrictions and difficulty in taking time off, it is necessary to suggest effective ways for workers to exercise regularly. Sustaining lifestyle habits that increase nonexercise activity in daily life can solve the issue of lack of exercise time. Healthy Lifestyle Coaching Chatbot is a messenger app based on the habit formation model that can be used as a tool to provide a health behavior intervention that emphasizes the importance of sustainability and involvement.
OBJECTIVE


This study aimed to assess the efficacy of the Healthy Lifestyle Coaching Chatbot intervention presented via a messenger app aimed at stair-climbing habit formation for office workers.
METHODS


From February 1, 2018, to April 30, 2018, a total of 106 people participated in the trial after online recruitment. Participants were randomly assigned to the intervention group (n=57) or the control group (n=49). The intervention group received cues and intrinsic and extrinsic rewards for the entire 12 weeks. However, the control group did not receive intrinsic rewards for the first 4 weeks and only received all rewards as in the intervention group from the fifth to twelfth week. The Self-Report Habit Index (SRHI) of participants was evaluated every week, and the level of physical activity was measured at the beginning and end of the trial. SPSS Statistics version 21 (IBM Corp) was used for statistical analysis.
RESULTS


After 4 weeks of intervention without providing the intrinsic rewards in the control group, the change in SRHI scores was 13.54 (SD 14.99) in the intervention group and 6.42 (SD 9.42) in the control group, indicating a significant difference between the groups (P=.04). When all rewards were given to both groups, from the fifth to twelfth week, the change in SRHI scores of the intervention and control groups was comparable at 12.08 (SD 10.87) and 15.88 (SD 13.29), respectively (P=.21). However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
CONCLUSIONS


This study provides evidence that intrinsic rewards are important to enhance the sustainability and effectiveness of an intervention. The Healthy Lifestyle Coaching Chatbot program can be a cost-effective method for healthy habit formation.
TRIAL REGISTRATION


Clinical Research Information Service KCT0004009; https://tinyurl.com/w4oo7md.",2020,"However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
","['Office Workers', 'office workers given their busy lives', 'From February 1, 2018, to April 30, 2018, a total of 106 people participated in the trial after online recruitment']","['Healthy Lifestyle Coaching Chatbot intervention', 'Healthy Lifestyle Coaching Chatbot App']","['Self-Report Habit Index (SRHI', 'level of physical activity', 'SRHI scores']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",106.0,0.0395995,"However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
","[{'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Piao', 'Affiliation': 'Office of Hospital Information, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeongju', 'Initials': 'H', 'LastName': 'Ryu', 'Affiliation': 'College of Nursing, Seoul National University, Jongno-gu, Republic of Korea.'}, {'ForeName': 'Hyeongsuk', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College\xa0of\xa0Nursing, Gachon\xa0University, Incheon, Republic of Korea.'}, {'ForeName': 'Jeongeun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Seoul National University, Jongno-gu, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/15085']
878,22449251,Randomised clinical trial: the benefit of combination therapy with adefovir and lamivudine for chronic hepatitis B.,"BACKGROUND


Combination antiviral therapy holds the promise of increasing response rates while decreasing antiviral resistance, but has yet to be shown to be beneficial or necessary in chronic hepatitis B.
AIM


To evaluate the benefit of combination therapy with adefovir and lamivudine versus adefovir alone in maintaining virological, biochemical and histological responses.
METHODS


Patients with chronic hepatitis B with and without previous lamivudine therapy were randomised to receive adefovir alone (10 mg/daily) or adefovir and lamivudine (100 mg/daily) for up to 192 weeks. Study endpoints were (i) maintained virological (HBV DNA <500 copies/mL), biochemical and histological response, (ii) loss of HBeAg and (iii) loss of HBsAg.
RESULTS


A total of 41 patients were enrolled, including 31 HBeAg -positive and 31 treatment-naïve subjects. 30 patients remained on assigned therapy at 192 weeks. The percentage of patients achieving a combined maintained response was higher in the combination than the monotherapy arm, both at week 48 (59% vs. 26%, P = 0.06) and 192 (68% vs. 31%, P = 0.03). At week 192, 76% of the combination vs. 36% of the monotherapy group had loss of HBeAg (P = 0.03). One patient receiving adefovir cleared HBsAg. Adefovir resistance developed in 6 of 19 (32%) monotherapy but none of 22 combination treated patients (P = 0.03).
CONCLUSIONS


Extended combination therapy with lamivudine and adefovir is associated with a high rate of long-term virological and biochemical response. Adefovir monotherapy appears to be less effective mainly because of poor initial response and the ultimate development of antiviral resistance (www.Clinical. Trials.gov NCT00023309).",2012,"The percentage of patients achieving a combined maintained response was higher in the combination than the monotherapy arm, both at week 48 (59% vs. 26%, P = 0.06) and 192 (68% vs. 31%, P = 0.03).","['chronic hepatitis B', '30 patients remained on assigned therapy at 192 weeks', '41 patients were enrolled, including 31 HBeAg -positive and 31 treatment-naïve subjects', 'Patients with chronic hepatitis B with and without previous lamivudine therapy']","['adefovir and lamivudine', 'adefovir and lamivudine versus adefovir alone', 'adefovir alone (10 mg/daily) or adefovir and lamivudine', 'lamivudine', 'Adefovir monotherapy']","['percentage of patients achieving a combined maintained response', 'loss of HBeAg', 'maintained virological (HBV DNA <500 copies/mL), biochemical and histological response, (ii) loss of HBeAg and (iii) loss of HBsAg', 'Adefovir resistance']","[{'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0050175', 'cui_str': 'adefovir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}]",41.0,0.239149,"The percentage of patients achieving a combined maintained response was higher in the combination than the monotherapy arm, both at week 48 (59% vs. 26%, P = 0.06) and 192 (68% vs. 31%, P = 0.03).","[{'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Ghany', 'Affiliation': 'Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Feld', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Heller', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Doo', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rotman', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nagabhyru', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Koh', 'Affiliation': ''}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': ''}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Hoofnagle', 'Affiliation': ''}]",Alimentary pharmacology & therapeutics,['10.1111/j.1365-2036.2012.05059.x']
879,31403574,Can Backward Sled Towing Potentiate Sprint Performance?,"Monaghan, DJ and Cochrane, DJ. Can backward sled towing potentiate sprint performance? J Strength Cond Res 34(2): 345-354, 2020-The objectives of this study were to determine whether backward sled towing can elicit a postactivation potentiation response to enhance forward 5-m sprint performance and to determine whether sled loading through a reduction in velocity can elicit an improvement in 5-m sprint performance. A randomized design was used to examine the effects of forward and backward sled tow loading of 35 and 55% reduction of individual's maximal velocity (rVelmean) on 5-m sprint performance. Eighteen well-trained male subjects performed 4 intervention sessions (55% rVelmean backward; 55% rVelmean forward; 35% rVelmean backward; and 35% rVelmean forward) separated by a minimum of 24 hours. Intervention sessions included baseline unresisted 5-m sprints, followed by 3 loaded sled tows over a distance of 3.2 m or 5 m for heavy and light loads, respectively. An unresisted 5-m sprint was completed after 6 and 12 minutes of rest. Mean sprint velocity, electromyography, sprint kinematic, and temporal data were collected during each session. Sled towing, irrespective of load or rest period, produced no significant change in 5-m sprint velocity (p > 0.05). In addition, there were no significant changes in electromyography, kinetic, and temporal data; however, current findings support previous research of confirming muscle activation and vertical force production during sprint acceleration. It is unclear whether individualizing a reduction in velocity is a superior method to percent body mass for optimizing sled loading in well-trained male subjects.",2020,"Sled towing, irrespective of load or rest period, produced no significant change in 5-m sprint velocity (p > 0.05).","['Eighteen well-trained male subjects', 'trained male subjects']",['J Strength Cond Res XX(X'],"['5-m sprint velocity', 'electromyography, kinetic, and temporal data', 'Mean sprint velocity, electromyography, sprint kinematic, and temporal data', '5-m sprint performance']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",18.0,0.0295148,"Sled towing, irrespective of load or rest period, produced no significant change in 5-m sprint velocity (p > 0.05).","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Monaghan', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Darryl J', 'Initials': 'DJ', 'LastName': 'Cochrane', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003322']
880,22499474,Two strategies to intensify evidence-based medicine education of undergraduate students: a randomised controlled trial.,"INTRODUCTION


Undergraduate evidence-based practice (EBP) is usually taught through standalone courses and workshops away from clinical practice. This study compared the effects of 2 clinically integrated educational strategies on final year medical students.
MATERIALS AND METHODS


Final year medical students rotating to the general medicine service for a 2-week internship were randomly assigned to participate in a weekly EBP-structured case conference focusing on students' primary care patients (Group A, n = 47), or to receive a weekly didactic lecture about EBP (Group B, n = 47). The teaching effects of these 2 interventions were evaluated by a validated instrument for assessment of EBP related knowledge (EBP-K), attitude (EBP-A), personal application (EBP-P), and anticipated future use (EBP-F) on the first and last days of rotation.
RESULTS


All scores improved significantly after the 2-week EBM-teaching for both groups. When compared to Group B, students in Group A had significantly higher post-intervention scores of EBP-K (21.2 ± 3.5 vs 19.0 ± 4.6; ie. 57.8 ± 72.9% vs 29.1 ± 39.1%; P <0.01) and EBP-P (18.7 ± 4.3 vs 15.3 ± 3.9; ie. 28.5 ± 25.5 % vs 14.1 ± 18.7 %; P <0.001). In contrast, the scores of EBP-A and EBP-F were similar between the 2 groups.
CONCLUSION


Structured case conference, when compared to the didactic lectures, significantly improved EBP-K and EBP-P for final year medical students.",2012,"When compared to Group B, students in Group A had significantly higher post-intervention scores of EBP-K (21.2 ± 3.5 vs 19.0 ± 4.6; ie. 57.8 ± 72.9% vs 29.1 ± 39.1%; P <0.01) and EBP-P (18.7 ± 4.3 vs 15.3 ± 3.9;","['final year medical students', 'Final year medical students rotating to the general medicine service for a 2-week internship', 'undergraduate students']","[""EBP-structured case conference focusing on students' primary care patients (Group A, n = 47), or to receive a weekly didactic lecture about EBP""]","['scores of EBP-A and EBP-F', 'EBP-K and EBP-P', 'EBP related knowledge (EBP-K), attitude (EBP-A), personal application (EBP-P), and anticipated future use (EBP-F']","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0021793', 'cui_str': 'Internship'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0556657', 'cui_str': 'Case conference (procedure)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",47.0,0.0508975,"When compared to Group B, students in Group A had significantly higher post-intervention scores of EBP-K (21.2 ± 3.5 vs 19.0 ± 4.6; ie. 57.8 ± 72.9% vs 29.1 ± 39.1%; P <0.01) and EBP-P (18.7 ± 4.3 vs 15.3 ± 3.9;","[{'ForeName': 'Hao Min', 'Initials': 'HM', 'LastName': 'Cheng', 'Affiliation': 'Department of Research and Education, Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Fei Ran', 'Initials': 'FR', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Teh Fu', 'Initials': 'TF', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Shao Yuan', 'Initials': 'SY', 'LastName': 'Chuang', 'Affiliation': ''}, {'ForeName': 'Hung Tsang', 'Initials': 'HT', 'LastName': 'Yen', 'Affiliation': ''}, {'ForeName': 'Fa Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Te Li', 'Initials': 'TL', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Wen Shin', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Chiao Lin', 'Initials': 'CL', 'LastName': 'Chuang', 'Affiliation': ''}, {'ForeName': 'Chen Huan', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Ho', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
881,31340089,Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis.,"BACKGROUND


Roxadustat (FG-4592) is an oral inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that stimulates erythropoiesis and regulates iron metabolism. In phase 2 studies involving patients with chronic kidney disease, roxadustat increased levels of endogenous erythropoietin to within or near the physiologic range, along with increasing hemoglobin levels and improving iron homeostasis. Additional data are needed regarding the efficacy and safety of roxadustat for the treatment of anemia in patients with chronic kidney disease who are not undergoing dialysis.
METHODS


In this phase 3 trial conducted at 29 sites in China, we randomly assigned 154 patients with chronic kidney disease in a 2:1 ratio to receive roxadustat or placebo three times a week for 8 weeks in a double-blind manner. All the patients had a hemoglobin level of 7.0 to 10.0 g per deciliter at baseline. The randomized phase of the trial was followed by an 18-week open-label period in which all the patients received roxadustat; parenteral iron was withheld. The primary end point was the mean change from baseline in the hemoglobin level, averaged over weeks 7 through 9.
RESULTS


During the primary-analysis period, the mean (±SD) change from baseline in the hemoglobin level was an increase of 1.9±1.2 g per deciliter in the roxadustat group and a decrease of 0.4±0.8 g per deciliter in the placebo group (P<0.001). The mean reduction from baseline in the hepcidin level (associated with greater iron availability) was 56.14±63.40 ng per milliliter in the roxadustat group and 15.10±48.06 ng per milliliter in the placebo group. The reduction from baseline in the total cholesterol level was 40.6 mg per deciliter in the roxadustat group and 7.7 mg per deciliter in the placebo group. Hyperkalemia and metabolic acidosis occurred more frequently in the roxadustat group than in the placebo group. The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period.
CONCLUSIONS


In Chinese patients with chronic kidney disease who were not undergoing dialysis, those in the roxadustat group had a higher mean hemoglobin level than those in the placebo group after 8 weeks. During the 18-week open-label phase of the trial, roxadustat was associated with continued efficacy. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652819.).",2019,"The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period.
","['patients with chronic kidney disease who are not undergoing dialysis', 'Patients with Kidney Disease', 'patients with chronic kidney disease', '29 sites in China, we randomly assigned 154 patients with chronic kidney disease in a 2:1 ratio to receive', 'Chinese patients with chronic kidney disease']","['FibroGen and FibroGen', 'placebo', 'Roxadustat (FG-4592', 'roxadustat or placebo']","['total cholesterol level', 'levels of endogenous erythropoietin', 'hemoglobin level', 'mean hemoglobin level', 'Hyperkalemia and metabolic acidosis', 'hemoglobin levels and improving iron homeostasis', 'mean change from baseline in the hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4310578'}, {'cui': 'C3713379', 'cui_str': 'FG-4592'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",154.0,0.14697,"The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period.
","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chuanming', 'Initials': 'C', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Aiping', 'Initials': 'A', 'LastName': 'Yin', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Changying', 'Initials': 'C', 'LastName': 'Xing', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Laimin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Bi-Cheng', 'Initials': 'BC', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leong', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Szczech', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Kin-Hung P', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}]",The New England journal of medicine,['10.1056/NEJMoa1813599']
882,32423467,The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam.,"BACKGROUND


Eliminating hepatitis C is hampered by the costs of direct-acting antiviral treatment and the need to treat hard-to-reach populations. Access could be widened by shortening or simplifying treatment, but limited research means it is unclear which approaches could achieve sufficiently high cure rates to be acceptable. We present the statistical aspects of a multi-arm trial designed to test multiple strategies simultaneously and a monitoring mechanism to detect and stop individual randomly assigned groups with unacceptably low cure rates quickly.
METHODS


The VIETNARMS trial will factorially randomly assign patients to two drug regimens, three treatment-shortening strategies or control, and adjunctive ribavirin or no adjunctive ribavirin with shortening strategies (14 randomly assigned groups). We will use Bayesian monitoring at interim analyses to detect and stop recruitment into unsuccessful strategies, defined by more than 0.95 posterior probability that the true cure rate is less than 90% for the individual randomly assigned group (non-comparative). Final comparisons will be non-inferiority for regimens (margin 5%) and strategies (margin 10%) and superiority for adjunctive ribavirin. Here, we tested the operating characteristics of the stopping guideline for individual randomly assigned groups, planned interim analysis timings and explored power at the final analysis.
RESULTS


A beta (4.5, 0.5) prior for the true cure rate produces less than 0.05 probability of incorrectly stopping an individual randomly assigned group with a true cure rate of more than 90%. Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited. Groups with moderately low cure rates (80%) are likely to stop (0.7 probability) before overall recruitment finishes. Interim analyses 7, 10, 13 and 18 months after recruitment commences provide good probabilities of stopping inferior individual randomly assigned groups. For an overall true cure rate of 95%, power is more than 90% to confirm non-inferiority in the regimen and strategy comparisons, regardless of the control cure rate, and to detect a 5% absolute difference in the ribavirin comparison.
CONCLUSIONS


The operating characteristics of the stopping guideline are appropriate, and interim analyses can be timed to detect individual randomly assigned groups that are highly likely to have suboptimal performance at various stages. Therefore, our design is suitable for evaluating treatment-shortening or -simplifying strategies.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN61522291. Registered on 4 October 2019.",2020,Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited.,['Vietnam'],"['shortening strategies or control, and adjunctive ribavirin or no adjunctive ribavirin with shortening strategies', 'ribavirin']",[],"[{'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}]",[],,0.124331,Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited.,"[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'McCabe', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK. leanne.mccabe@ucl.ac.uk.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Hospital for Tropical Diseases, 764 Vo Van Kiet, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Barnes', 'Affiliation': 'Oxford University, South Parks Road, OX1 3SY, Oxford, UK.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Pett', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Cooke', 'Affiliation': 'Imperial College London, SW7 2AZ, London, Kensington, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04350-x']
883,32423454,"Neck-specific strengthening exercise compared with sham ultrasound when added to home-stretching exercise in patients with migraine: study protocol of a two-armed, parallel-groups randomized controlled trial.","BACKGROUND


Migraine is a highly disabling condition and pharmacological treatment is the gold standard. However, several patients have also positive responses to the application of different manual techniques and therapeutic exercises in terms of reducing the intensity and frequency of migraine attacks. Nevertheless, the effects of a neck-specific exercise program have not yet been evaluated in these patients.
OBJECTIVE


To determine the effectiveness of a neck-specific exercise program in reducing the intensity and frequency of migraine attacks as compared to a sham ultrasound group.
METHODS


A two-armed, parallel-groups randomized controlled trial with 3 months of follow-up will be conducted. 42 individuals, both genders, aged between 18 and 55 years old with a medical diagnosis of migraine will be included. The intervention group will perform a protocol consisting of exercises for strengthening the muscles of the cervical spine. Participants within the sham ultrasound group will receive detuned ultrasound therapy in the upper trapezius muscle. Both groups will receive a weekly session for 8 weeks. The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
TRIAL REGISTRATION


This study was registered under access code RBT-8gfv5j in the Registro Brasileiro de Ensaios Clínicos (ReBEC) in November 28, 2016.
CONCLUSION


This study will aim to determine the efficacy of a neck-specific exercise program in reducing the frequency and intensity of migraine attacks. If the results show that a neck-specific exercise program is effective in reducing the frequency and intensity of migraine attacks, therapists will have a low cost and easily applicable tool to treat migraine.",2020,"The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
","['patients with migraine', '42 individuals, both genders, aged between 18 and 55\u2009years old with a medical diagnosis of migraine will be included']","['sham ultrasound when added to home-stretching exercise', 'sham ultrasound group will receive detuned ultrasound therapy', 'neck-specific exercise program', 'Neck-specific strengthening exercise']","['frequency and intensity of migraine attacks', 'intensity and frequency of migraine attacks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",,0.0880203,"The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
","[{'ForeName': 'Mariana Tedeschi', 'Initials': 'MT', 'LastName': 'Benatto', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil. mariana.benatto@gmail.com.'}, {'ForeName': 'Lidiane Lima', 'Initials': 'LL', 'LastName': 'Florencio', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Marcela Mendes', 'Initials': 'MM', 'LastName': 'Bragatto', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Fabíola', 'Initials': 'F', 'LastName': 'Dach', 'Affiliation': 'Department of Neurosciences and Behavioral Sciences - Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Bevilaqua-Grossi', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00313-w']
884,31395858,Impact of energy turnover on the regulation of glucose homeostasis in healthy subjects.,"OBJECTIVE


Sedentary lifestyle increases the risk of type 2 diabetes. The aim of this study was to investigate the impact of different levels of energy turnover (ET; low, medium, and high level of physical activity and the corresponding energy intake) on glucose metabolism at zero energy balance, caloric restriction, and overfeeding.
METHODS


Sixteen healthy individuals (13 men, 3 women, 25.1 ± 3.9 years, BMI 24.0 ± 3.2 kg/m 2 ) participated in a randomized crossover intervention under metabolic ward conditions. Subjects passed 3 × 3 intervention days. Three levels of physical activity (PAL: low 1.3, medium 1.6, and high 1.8 achieved by walking at 4 km/h for 0, 3 × 55, or 3 × 110 min) were compared under three levels of energy balance (zero energy balance (EB): 100% of energy requirement (Ereq); caloric restriction (CR): 75% Ereq, and overfeeding (OF): 125% Ereq). Continuous interstitial glucose monitoring, C-peptide excretion, and HOMA-IR, as well as postprandial glucose and insulin were measured.
RESULTS


Daylong glycemia and insulin secretion did not increase with higher ET at all conditions of energy balance (EB, CR, and OF), despite a correspondingly higher CHO intake (Δ low vs. high ET: +86 to 135 g of CHO/d). At CR, daylong glycemia (p = 0.02) and insulin secretion (p = 0.04) were even reduced with high compared with low ET. HOMA-IR was impaired with OF and improved with CR, whereas ET had no effect on fasting insulin sensitivity. A higher ET led to lower postprandial glucose and insulin levels under conditions of CR and OF.
CONCLUSION


Low-intensity physical activity can significantly improve postprandial glycemic response of healthy individuals, independent of energy balance.",2019,"At CR, daylong glycemia (p = 0.02) and insulin secretion (p = 0.04) were even reduced with high compared with low ET.","['healthy individuals', 'healthy subjects', 'Sixteen healthy individuals (13 men, 3 women, 25.1\u2009±\u20093.9 years, BMI 24.0\u2009±\u20093.2\u2009kg/m 2 ']",['Low-intensity physical activity'],"['energy balance (EB, CR, and OF', 'Daylong glycemia and insulin secretion', 'CHO intake', 'daylong glycemia', 'glucose metabolism at zero energy balance, caloric restriction, and overfeeding', 'Continuous interstitial glucose monitoring, C-peptide excretion, and HOMA-IR, as well as postprandial glucose and insulin', 'energy turnover (ET', 'HOMA-IR', 'postprandial glucose and insulin levels', 'physical activity', 'insulin secretion', 'fasting insulin sensitivity', 'postprandial glycemic response']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",16.0,0.0203393,"At CR, daylong glycemia (p = 0.02) and insulin secretion (p = 0.04) were even reduced with high compared with low ET.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Büsing', 'Affiliation': 'Institute of Human Nutrition and Food Science, Christian-Albrechts University of Kiel, Kiel, Germany.'}, {'ForeName': 'Franziska Anna', 'Initials': 'FA', 'LastName': 'Hägele', 'Affiliation': 'Institute of Human Nutrition and Food Science, Christian-Albrechts University of Kiel, Kiel, Germany.'}, {'ForeName': 'Alessa', 'Initials': 'A', 'LastName': 'Nas', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Hasler', 'Affiliation': 'Applied Statistics, Faculty of Agricultural and Nutritional Sciences, Christian-Albrechts University of Kiel, Kiel, Germany.'}, {'ForeName': 'Manfred James', 'Initials': 'MJ', 'LastName': 'Müller', 'Affiliation': 'Institute of Human Nutrition and Food Science, Christian-Albrechts University of Kiel, Kiel, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bosy-Westphal', 'Affiliation': 'Institute of Human Nutrition and Food Science, Christian-Albrechts University of Kiel, Kiel, Germany. abosyw@nutrition.uni-kiel.de.'}]",Nutrition & diabetes,['10.1038/s41387-019-0089-6']
885,32422097,"In irritable bowel syndrome, fecal microbiota transplantation improved symptoms at 3 months.","SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A, Hausken T.  Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.  Gut. 2020;69:859-67. 31852769.",2020,"SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A,",['patients with irritable bowel syndrome'],"['faecal microbiota transplantation', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812731,"SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A,","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia (N.J.T., M.I.).'}, {'ForeName': 'Mudar', 'Initials': 'M', 'LastName': 'Irani', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia (N.J.T., M.I.).'}]",Annals of internal medicine,['10.7326/ACPJ202005190-052']
886,30654713,The Effect of an HIV Self-Management Intervention on Neurocognitive Behavioral Processing.,"People living with HIV (PLHIV) are increasingly diagnosed with comorbidities which require increasing self-management. We examined the effect of a self-management intervention on neurocognitive behavioral processing. Twenty-nine PLHIV completed a two-group, 3-month randomized clinical trial testing a self-management intervention to improve physical activity and dietary intake. At baseline and 3 months later, everyone completed validated assessments of physical, diet, and neurocognitive processing (functional magnetic resonance imaging [fMRI]-derived network analyses). We used linear mixed effects modeling with a random intercept to examine the effect of the intervention. The intervention improved healthy eating ( p  = .08) but did not improve other self-management behaviors. There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p  = .047) and an increase in the default mode network (DMN) differentiation ( p  = .10). Self-management interventions may influence neurocognitive processing in PLHIV, but those changes were not associated with positive changes in self-management behavior.",2019,There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p  = .047) and an increase in the default mode network (DMN) differentiation ( p  = .10).,"['People living with HIV (PLHIV', 'Twenty-nine PLHIV']","['HIV Self-Management Intervention', 'self-management intervention', 'self-management intervention to improve physical activity and dietary intake']","['Neurocognitive Behavioral Processing', 'physical, diet, and neurocognitive processing (functional magnetic resonance imaging [fMRI]-derived network analyses', 'self-management behaviors', 'neurocognitive behavioral processing', 'default mode network (DMN) differentiation', 'healthy eating', 'task positive network (TPN) differentiation']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",29.0,0.0334739,There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p  = .047) and an increase in the default mode network (DMN) differentiation ( p  = .10).,"[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Webel', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Schreiner', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Jack', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': '3 Kent State University, OH, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}]",Western journal of nursing research,['10.1177/0193945918823347']
887,32422098,"In adults with AF who regularly drink alcohol, a 6-month abstinence intervention reduced AF recurrence and burden.","SOURCE CITATION


Voskoboinik A, Kalman JM, De Silva A, et al.  Alcohol abstinence in drinkers with atrial fibrillation.  N Engl J Med. 2020;382:20-8. 31893513.",2020,"SOURCE CITATION


Voskoboinik A, Kalman JM, De Silva A, et al.  ",['drinkers with atrial fibrillation'],['Alcohol abstinence'],['AF recurrence and burden'],"[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0204255,"SOURCE CITATION


Voskoboinik A, Kalman JM, De Silva A, et al.  ","[{'ForeName': 'Meghana', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': 'Memorial Hermann Hospital, Katy, Texas, USA (M.G.).'}, {'ForeName': 'Vijaiganesh', 'Initials': 'V', 'LastName': 'Nagarajan', 'Affiliation': 'University of Texas, Houston, Texas, USA (V.N.).'}]",Annals of internal medicine,['10.7326/ACPJ202005190-053']
888,32422099,"In acute HF, intensive and sustained vasodilation did not reduce a composite of death or HF readmission at 180 days.","SOURCE CITATION


Kozhuharov N, Goudev A, Flores D, et al.  Effect of a strategy of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization among patients with acute heart failure: the GALACTIC randomized clinical trial.  JAMA. 2019;322:2292-302. 31846016.",2020,Effect of a strategy of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization among patients with acute heart failure: the GALACTIC randomized clinical trial.  ,['patients with acute heart failure'],['comprehensive vasodilation vs usual care'],"['mortality and heart failure rehospitalization', 'composite of death or HF readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}]","[{'cui': 'C0042401', 'cui_str': 'Vasodilatation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",,0.0940406,Effect of a strategy of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization among patients with acute heart failure: the GALACTIC randomized clinical trial.  ,"[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Santulli', 'Affiliation': ""Albert Einstein College of Medicine-Montefiore University Hospital, New York, New York, USA, University of Naples 'Federico II' and ITME, Naples, Italy (G.S.).""}]",Annals of internal medicine,['10.7326/ACPJ202005190-054']
889,31082790,"Addition of oat bran reduces HDL-C and does not potentialize effect of a low-calorie diet on remission of metabolic syndrome: A pragmatic, randomized, controlled, open-label nutritional trial.","OBJECTIVES


It is unclear whether addition of soluble fiber to a low-calorie diet potentializes weight loss and amelioration of metabolic syndrome (MetS). The aim of this study was to analyze the effects of oat bran on prevalence of MetS and associated disorders.
METHODS


A pragmatic, randomized controlled, 6-wk nutritional trial was carried out with 154 outpatients (mean age 47.6 ± 12.6 y of age). The intervention group (n = 83) received a low-calorie diet plus 40 g/d of oat bran; the control group (n = 71) received a low-calorie diet only. MetS parameters and prevalence were calculated and compared (using two-tailed statistical tests) before and after follow-up.
RESULTS


After follow-up, a significant but similar reduction was observed in MetS prevalence (40% reduction, 63% and 64.8% prevalence in intervention and control groups, respectively; P = 0.226), body mass index, body weight, waist circumference, systolic and diastolic blood pressures, triacylglycerides, and blood glucose levels in both groups (P < 0.05). Mean high-density lipoprotein cholesterol (HDL-C) was reduced in the intervention group (43.6 ± 9.6 to 41.2 ± 9.5 mg/dL; P = 0.025), but not in the control group (44.6 ± 10.5 to 44.5 ± 12.1 mg/dL; P = 0.890). There was no significant difference in any of the variables between the groups, although the P-value for HDL-C was almost significant (P = 0.078). Calorie and dietetic fiber intake during the 6-wk period were similar in both groups.
CONCLUSIONS


Daily consumption of oat bran did not potentialize the beneficial effects of a traditional low-calorie diet on the prevalence of MetS and associated disorders. Additionally, it reduced HDL-C.",2019,"Mean high-density lipoprotein cholesterol (HDL-C) was reduced in the intervention group (43.6 ± 9.6 to 41.2 ± 9.5 mg/dL; P = 0.025), but not in the control group (44.6 ± 10.5 to 44.5 ± 12.1 mg/dL; P = 0.890).",['154 outpatients (mean age 47.6 ± 12.6 y of age'],"['low-calorie diet plus 40 g/d of oat bran; the control group (n\u202f=\u202f71) received a low-calorie diet only', 'oat bran']","['remission of metabolic syndrome', 'body mass index, body weight, waist circumference, systolic and diastolic blood pressures, triacylglycerides, and blood glucose levels', 'MetS prevalence', 'prevalence of MetS and associated disorders', 'Calorie and dietetic fiber intake', 'HDL-C', 'Mean high-density lipoprotein cholesterol (HDL-C']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}]","[{'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0795649', 'cui_str': 'OAT BRAN'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}]",154.0,0.0313054,"Mean high-density lipoprotein cholesterol (HDL-C) was reduced in the intervention group (43.6 ± 9.6 to 41.2 ± 9.5 mg/dL; P = 0.025), but not in the control group (44.6 ± 10.5 to 44.5 ± 12.1 mg/dL; P = 0.890).","[{'ForeName': 'Leila Sicupira Carneiro de Souza', 'Initials': 'LSCS', 'LastName': 'Leão', 'Affiliation': 'Department of Nutrition and Public Health, Federal University of Rio de Janeiro State, Rio de Janeiro, Brazil. Electronic address: leilaleao@gmail.com.'}, {'ForeName': 'Luana Azevedo de', 'Initials': 'LA', 'LastName': 'Aquino', 'Affiliation': 'Department of Nutrition and Public Health, Federal University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Juliana Furtado', 'Initials': 'JF', 'LastName': 'Dias', 'Affiliation': 'Department of Applied Nutrition, Federal University of Rio de Janeiro State, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosalina Jorge', 'Initials': 'RJ', 'LastName': 'Koifman', 'Affiliation': 'Department of Epidemiology and Quantitative Methods in Health, National School of Public Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.03.007']
890,32422100,"In unprotected left main CAD, revascularization with PCI and DES increased risk for MACCE vs CABG at 5 years.","SOURCE CITATION


Holm NR, Mäkikallio T, Lindsay MM, et al.  Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.  Lancet. 2019;395:191-9. 31879028.",2020,"Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.  ",['unprotected left main stenosis'],['Percutaneous coronary angioplasty versus coronary artery bypass grafting'],[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0002997', 'cui_str': 'Angioplasty, Coronary Balloon'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",[],,0.0876096,"Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.  ","[{'ForeName': 'Saraschandra', 'Initials': 'S', 'LastName': 'Vallabhajosyula', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA (S.V., M.R.B.).'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'Bell', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA (S.V., M.R.B.).'}]",Annals of internal medicine,['10.7326/ACPJ202005190-055']
891,31843791,Role of internal limiting membrane peeling in the prevention of epiretinal membrane formation following vitrectomy for retinal detachment: a randomised trial.,"AIM


To study the role of internal limiting membrane (ILM) peeling in the prevention of macular epiretinal membrane (ERM) formation following pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD).
METHODS


In a randomised trial, patients with macula-off RRD (duration ≤3 months) with proliferative vitreoretinopathy grade ≤C1 and absence of pre-existing maculopathy were recruited from June 2016 to May 2018. Patients were randomised into two groups: group 1 (conventional treatment) underwent PPV alone, while group 2 underwent PPV with macular ILM peeling. The main outcome measures were macular ERM formation (detected on optical coherence tomography), corrected distance visual acuity (CDVA), retinal attachment and central macular thickness (CMT) at last follow-up (minimum 6 months).
RESULTS


Sixty patients (30 in each group) completed the required follow-up. The two groups were comparable in sex distribution, age, duration of RRD, baseline CDVA and duration of follow-up (median 15.5 vs 14 months). Macular ERM developed in 20% (n=6) and 0% of eyes in groups 1 and 2, respectively (p=0.002). Retinal reattachment was attained in all eyes. There was no statistical difference in final CDVA between the groups (p=0.43). Dissociated optic nerve fibre layer (DONFL) was found in 0% and 40% (n=12) of eyes in groups 1 and 2, respectively (p=0.0001). However, DONFL did not significantly affect the final CDVA (p=0.84). The final CMT was 266.0±37.5 µm and 270.0±73.7 µm in groups 1 and 2, respectively, with no statistical difference (p=0.62).
CONCLUSIONS


ILM peeling prevents macular ERM formation following PPV for RRD but provides similar visual outcomes as compared with conventional treatment.
TRIAL REGISTRATION NUMBER


CTRI2018/04/012978.",2020,"Macular ERM developed in 20% (n=6) and 0% of eyes in groups 1 and 2, respectively (p=0.002).","['retinal detachment', 'Sixty patients (30 in each group) completed the required follow-up', 'patients with macula-off RRD (duration ≤3 months) with proliferative vitreoretinopathy grade ≤C1\u2009and absence of pre-existing maculopathy were recruited from June 2016 to May 2018', 'rhegmatogenous retinal detachment (RRD']","['vitrectomy', 'pars plana vitrectomy (PPV', 'internal limiting membrane (ILM) peeling', 'ILM peeling', 'PPV alone', 'internal limiting membrane peeling', 'PPV with macular ILM peeling']","['Macular ERM', 'macular ERM formation', 'Retinal reattachment', 'final CDVA', 'macular ERM formation (detected on optical coherence tomography), corrected distance visual acuity (CDVA), retinal attachment and central macular thickness (CMT', 'final CMT', 'Dissociated optic nerve fibre layer (DONFL']","[{'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332573', 'cui_str': 'Macule (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242852', 'cui_str': 'Vitreoretinopathy Neovascular Inflammatory'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0441602', 'cui_str': 'Peeling - action (qualifier value)'}]","[{'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0185042', 'cui_str': 'Refixation (procedure)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0029130', 'cui_str': 'Cranial Nerve II'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",60.0,0.128873,"Macular ERM developed in 20% (n=6) and 0% of eyes in groups 1 and 2, respectively (p=0.002).","[{'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Devashish', 'Initials': 'D', 'LastName': 'Dubey', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Devesh', 'Initials': 'D', 'LastName': 'Kumawat', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India deveshkumawat21@gmail.com.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Markan', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Parijat', 'Initials': 'P', 'LastName': 'Chandra', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Chandra', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315095']
892,31536112,"Exercise for Smoking Cessation in Postmenopausal Women: A Randomized, Controlled Trial.","BACKGROUND


Postmenopausal smokers have difficulty quitting smoking and experience considerable weight gain with smoking cessation. We examined whether adjunctive smoking treatment with exercise, compared to a relaxation control condition, could improve cigarette abstinence, decrease cigarettes smoked per day (CPD), and ameliorate changes in body mass index (BMI) in postmenopausal smokers.
METHODS


Women (N = 301) signed informed consent and were randomized to treatment at two sites (Universities of Connecticut and Minnesota). We randomized groups of participants to a comprehensive group treatment program that included 12 weeks of varenicline and either a moderate exercise or relaxation component for 6 months. Participants were followed for a year after medication treatment.
RESULTS


Overall, 17.3% of patients reported carbon monoxide-verified continuous abstinence for the 9- to 12-week period, and 11.6% reported prolonged abstinence at 1 year, with no significant differences between treatment conditions. CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment. The Exercise condition reported smoking fewer CPD over time, and that advantage widened over time. In terms of BMI, significant effects for time in weeks, and for the interaction of Week × Treatment condition, reflected gradually increasing BMI in these women over time, but with the increase in BMI slower in the Exercise condition.
CONCLUSIONS


Exercise, compared to relaxation, was associated with a reduced BMI and CPD in postmenopausal women, but did not increase end of treatment or prolonged abstinence. Further research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.
IMPLICATIONS


This study adds to the literature on the effectiveness of a moderate exercise intervention compared to a relaxation control condition as an adjunctive treatment for smoking cessation in postmenopausal women. Our exercise program did not increase end of treatment or prolonged abstinence rates in postmenopausal women; however, there was a beneficial effect on smoking reduction and reduced body mass index. Additional research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.",2020,"CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment.","['Postmenopausal smokers', 'Women ', 'postmenopausal smokers', 'postmenopausal women', 'Post-Menopausal Women']","['moderate exercise intervention', 'relaxation control condition', 'Exercise', 'varenicline and either a moderate exercise or relaxation component']","['carbon monoxide-verified continuous abstinence', 'prolonged abstinence', 'BMI', 'smoking cessation rates', 'prolonged abstinence rates', 'BMI and CPD', 'BMI slower', 'cigarette abstinence, decrease cigarettes smoked per day (CPD) and ameliorate changes in body mass index (BMI']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0292739,"CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment.","[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Oncken', 'Affiliation': 'Department of Medicine, UConn School of Medicine, Farmington, CT.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Litt', 'Affiliation': 'Department of Behavioral Sciences, UConn School of Dental Medicine, Farmington, CT.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kenny', 'Affiliation': 'Department of Medicine, UConn School of Medicine, Farmington, CT.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Lando', 'Affiliation': 'Department of Epidemiology, University of Minnesota, Minneapolis, MN (Lando).'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine, University of Arizona, Tuscon, AZ.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Dornelas', 'Affiliation': 'Department of Medicine, UConn School of Medicine, Farmington, CT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz176']
893,31302767,Oral cryotherapy for oral mucositis management in patients receiving allogeneic hematopoietic stem cell transplantation: a prospective randomized study.,"PURPOSE


To explore the best schedule of oral cryotherapy for the prevention of oral mucositis in recipients of myeloablative hematopoietic stem cell transplantation (HSCT).
METHODS


A prospective randomized study was conducted to recruit allogeneic HSCT recipients, who were then randomly allocated into four arms to accept the following: oral cryotherapy during the whole course (arm A) or second half of the course (arm B) of cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D). Status of oral mucositis was daily assessed from the first day of conditioning to the 15th day post-HSCT. A myeloablative conditioning regimen was used which was composed of busulfan, cyclophosphamide, and cytarabine.
RESULTS


Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment. Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678). The highest incidence of severe mucositis was observed in arm C. Recovery of mucositis also had a significant diversity among the 4 arms (F = 4.133, p = 0.008).
CONCLUSIONS


Risk and outcome of severe oral mucositis could be ameliorated by oral cryotherapy during the administration of cytotoxic agents for allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen, and a half-course schedule could acquire a comparable efficacy compared with the whole-course schedule.",2020,"Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678).","['allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen', 'recruit allogeneic HSCT recipients', 'recipients of myeloablative hematopoietic stem cell transplantation (HSCT', 'Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment', 'patients receiving allogeneic hematopoietic stem cell transplantation']","['oral cryotherapy', 'Oral cryotherapy', 'busulfan, cyclophosphamide, and cytarabine', 'cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D']","['Status of oral mucositis', 'severe mucositis', 'lower incidence and short duration of severe mucositis', 'mucositis', 'severe oral mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}]",160.0,0.0126175,"Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678).","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Xiaming', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Pingfang', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Shizhen', 'Initials': 'S', 'LastName': 'Teng', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Haifang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Nursing, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu Province, People's Republic of China. nswanghaifang@sina.com.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04966-z']
894,31580144,Cluster randomised trials with different numbers of measurements at baseline and endline: Sample size and optimal allocation.,"BACKGROUND/AIMS


Published methods for sample size calculation for cluster randomised trials with baseline data are inflexible and primarily assume an equal amount of data collected at baseline and endline, that is, before and after the intervention has been implemented in some clusters. We extend these methods to any amount of baseline and endline data. We explain how to explore sample size for a trial if some baseline data from the trial clusters have already been collected as part of a separate study. Where such data aren't available, we show how to choose the proportion of data collection devoted to the baseline within the trial, when a particular cluster size or range of cluster sizes is proposed.
METHODS


We provide a design effect given the cluster size and correlation parameters, assuming different participants are assessed at baseline and endline in the same clusters. We show how to produce plots to identify the impact of varying the amount of baseline data accounting for the inevitable uncertainty in the cluster autocorrelation. We illustrate the methodology using an example trial.
RESULTS


Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation.
CONCLUSION


Investigators should think carefully before collecting baseline data in a cluster randomised trial if this is at the expense of endline data. In some scenarios, this will increase the sample size required to achieve given power and precision.",2020,"RESULTS


Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation.
",[],[],[],[],[],[],,0.33338,"RESULTS


Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation.
","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'Institute for Clinical Trials Methodology, MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774519873888']
895,32130065,Normal Gaze Patterns of the Face in Lateral View.,"Importance:  Current efforts to quantify the attentional distraction of facial deformities have been limited to deformities that are best perceived when the face is in frontal view, and there remains a paucity of knowledge of societal perception of the face in lateral view. To date, no attempts have been made to characterize the fixation patterns of the face in lateral view.  Objective:  To characterize the fixation patterns and gaze patterns of the face in lateral view.  Design, Setting, and Participants:  This was a prospective randomized controlled trial at an academic tertiary medical center. Eighty participants (mean age 23.6 ± 1.7 years, 52.5% female) gazed freely at 11 images of faces in lateral view for 10 s each as an infrared eye-tracker recorded eye movements in real time.  Main Outcomes and Measures:  Recorded eye movements are superimposed on the images to visualize areas of interest (AOIs) that attract the most attention. Fixation duration targeted at each AOI is transformed into relative fixation of the entire face and neck. Hotelling's test of variance followed by post hoc  t -testing assessed for the significance of fixation differences between the mouth and cheeks.  Results:  Participants spent an average of 6.0 (95% CI 5.8-6.2) s gazing at the face and neck areas of each image. Of this attention, 2.8 s or 49.8% (45.4-54.2%) was directed toward the eye, followed distantly by the nose (mean, 95% CI) (16.4%, 14.5-18.3%), cheek (12.0%, 11.4-14.5%), neck (4.6%, 3.8-5.4%), and mouth (4.0%, 3.4-4.6%). These differences were found to be significant by Hotelling's analysis and post hoc testing. A student's  t -test also indicated observers directed significantly more attention within the eye-nose-cheek triangle [4.6 s or 79.5% (75.6-83.5)] compared with the eye-nose-mouth triangle [4.1 s or 71.2% (66.9-75.5)] ( p  < 0.001).  Conclusions and Relevance:  When perceiving novel faces in lateral view, casual observers preferentially directed attention toward the eye, nose, and cheek. These findings suggest that we draw from a slightly different collection of features to build a schema of the sagittal face, which may serve to complement the central triangle and build upon a three-dimensional model of the ""normal"" human face.  Level of Evidence:  NA.",2020,A student's  t -test also indicated observers directed significantly more attention within the eye-nose-cheek triangle [4.6 s or 79.5% (75.6-83.5)] compared with the eye-nose-mouth triangle [4.1 s or 71.2% (66.9-75.5)] ( p  < 0.001).  ,"['Eighty participants (mean age 23.6\u2009±\u20091.7 years, 52.5% female) gazed freely at 11 images of faces in lateral view for 10\u2009s each as an', 'academic tertiary medical center']",['infrared eye-tracker recorded eye movements in real time'],['attention within the eye-nose-cheek triangle'],"[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0007966', 'cui_str': 'Bucca'}, {'cui': 'C0205119', 'cui_str': 'Triangular (qualifier value)'}]",,0.0487042,A student's  t -test also indicated observers directed significantly more attention within the eye-nose-cheek triangle [4.6 s or 79.5% (75.6-83.5)] compared with the eye-nose-mouth triangle [4.1 s or 71.2% (66.9-75.5)] ( p  < 0.001).  ,"[{'ForeName': 'Pauline P', 'Initials': 'PP', 'LastName': 'Huynh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Ishii', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Juarez', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Halley M', 'Initials': 'HM', 'LastName': 'Darrach', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Fung', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Nellis', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Byrne', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kofi D O', 'Initials': 'KDO', 'LastName': 'Boahene', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ira D', 'Initials': 'ID', 'LastName': 'Papel', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Theda C', 'Initials': 'TC', 'LastName': 'Kontis', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Ishii', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2019.29019.huy']
896,31433352,A randomized pilot study to investigate the effect of opioids on immunomarkers using gene expression profiling during surgery.,"Endogenous opioid peptides and exogenous opioids modulate immune function, and animal and human studies have shown that some have a depressant immunomodulatory effect. This is potentially of high clinical significance, eg, in cancer patients and surgery. The primary objective of this pilot study was to evaluate the effect of morphine and oxycodone on immune pathways associated with immunosuppression in gynecological laparotomy patients. Gene expression was analyzed in CD4, CD8, and natural killer (NK) cells using the 3' Affymetrix microarray. Patients were randomized to receive morphine, oxycodone, or nonopioid ""control"" analgesia during and after surgery. Genes demonstrating differential expression were those with a ≥±2-fold difference and P-value ≤0.05 after analysis of variance. Cytometric bead array and NK cell degranulation assay were used to investigate changes in serum cytokine concentration and in NK cell cytotoxicity, respectively. Forty patients had satisfactory RNA which was hybridized to gene chips. Genes were identified (Partek Genomics Suite 6.6) at baseline, 2, 6, and 24 hours and were either ≥2-fold upregulated or downregulated from baseline. At 2 hours, a large number of genes were downregulated with morphine but not with control analgesia or oxycodone. Statistically significant increases in IL-6 concentrations were induced by morphine only; NK cell activity was suppressed with morphine, but maintained with oxycodone and epidural analgesia. Gene expression profiles suggest that at 2 hours, post incision morphine appeared to be immunosuppressive as compared to oxycodone and nonopioid control analgesia.",2019,"Statistically significant increases in IL-6 concentrations were induced by morphine only; NK cell activity was suppressed with morphine, but maintained with oxycodone and epidural analgesia.","['cancer patients and surgery', 'Forty patients had satisfactory RNA which was hybridized to gene chips', 'gynecological laparotomy patients']","[""morphine, oxycodone, or non-opioid 'control' analgesia"", 'morphine and oxycodone', 'opioids', 'oxycodone', 'morphine']","['Gene expression', 'CD4+, CD8+ and NK cells', 'serum cytokine concentration and in NK cell cytotoxicity', 'IL-6 concentrations']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0872345', 'cui_str': 'Gene Chips'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",40.0,0.0445555,"Statistically significant increases in IL-6 concentrations were induced by morphine only; NK cell activity was suppressed with morphine, but maintained with oxycodone and epidural analgesia.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Wodehouse', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Demopoulos', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Petty', 'Affiliation': 'Institute of Cancer, Centre for Haemato-Oncology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Miraki-Moud', 'Affiliation': 'Institute of Cancer, Centre for Haemato-Oncology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Belhaj', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Husband', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fulton', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Randive', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Oksche', 'Affiliation': 'Mundipharma Research GmbH & Co, KG, Limburg, Germany.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Mehta', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Institute of Cancer, Centre for Haemato-Oncology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Langford', 'Affiliation': 'Pain and Anaesthesia Research Centre, Barts Health NHS Trust, London, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000001677']
897,30061157,Pericardial effusion in Hodgkin lymphoma: a report from the Children's Oncology Group AHOD0031 protocol.,,2018,,['Hodgkin lymphoma'],[],['Pericardial effusion'],"[{'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]",[],"[{'cui': 'C0349077', 'cui_str': 'Pericardial effusion - noninflammatory (disorder)'}]",,0.0162786,,"[{'ForeName': 'Lianna J', 'Initials': 'LJ', 'LastName': 'Marks', 'Affiliation': 'Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McCarten', 'Affiliation': 'Warren Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Qinglin', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Friedman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Schwartz', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI; and.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics, Roswell Park Cancer Institute, Buffalo, NY.'}]",Blood,['10.1182/blood-2018-02-834465']
898,31345652,Medical nihilism: The limits of a decontextualised critique of medicine.,"In a new and interesting book entitled Medical Nihilism (2018), Jacob Stegenga attempts to convince us that modern medical therapies are less effective than we think. Given the heterogeneity of hypotheses in medicine and the evidence for or against them, I argue that such a decontextualised critique cannot be made unless substantially weakened. Instead, I put forward an alternative, more nuanced and defensible epistemic view of medicine. According to this view, evaluating medical evidence requires analysis of both the methods of research e.g. randomised controlled trial (RCT), and context-specific information. This is because the way a trial (even an RCT) is conducted e.g. the population recruited and how it is intervened on, will vary and will have significant effects on the likelihood of a positive outcome. Moreover, the relationship between the positive outcome of a trial and the actual effectiveness of an intervention (the trial validity) will depend on these context specific factors. I argue for this position against nihilism by showing how each of Stegenga's individual claims about medical trials (trials are biased in favour of positive outcomes etc) can be questioned by taking the context into consideration.",2020,"Moreover, the relationship between the positive outcome of a trial and the actual effectiveness of an intervention (the trial validity) will depend on these context specific factors.",[],[],[],[],[],[],,0.0576744,"Moreover, the relationship between the positive outcome of a trial and the actual effectiveness of an intervention (the trial validity) will depend on these context specific factors.","[{'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Devanesan', 'Affiliation': ""St Bartholomew's Hospital, West Smithfield, London, EC1A 7BE, UK. Electronic address: adevanesan@doctors.org.uk.""}]",Studies in history and philosophy of biological and biomedical sciences,['10.1016/j.shpsc.2019.101189']
899,32004644,Placebo tailoring improves patient satisfaction of treatment plans in atopic dermatitis.,,2020,,['atopic dermatitis'],['Placebo'],['patient satisfaction'],"[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.152719,,"[{'ForeName': 'Arjun M', 'Initials': 'AM', 'LastName': 'Bashyam', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina. Electronic address: arjun.m.bashyam@gmail.com.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Cuellar-Barboza', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Rima I', 'Initials': 'RI', 'LastName': 'Ghamrawi', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina; Department of Pathology, Wake Forest School of Medicine, Winston-Salem, North Carolina; Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina; Department of Dermatology, University of Southern Denmark, Odense, Denmark.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.01.044']
900,20061311,Problem-solving skills training for vulnerable families of children with persistent asthma: report of a randomized trial on health-related quality of life outcomes.,"OBJECTIVES


To test the efficacy of problem-solving skill training (PST) in improving health-related quality of life (HRQOL) of children with persistent asthma from predominantly lower socioeconomic status (SES) Spanish-speaking Hispanic families.
METHODS


Randomized controlled trial comparing standard care waitlist (SC) control, home-visiting asthma education/care coordination (CC), and combined intervention (CC + PST) at baseline, after intervention, and 6-month follow-up. The primary outcome was parent proxy-report child HRQOL (PedsQL).
RESULTS


Participants (n = 252) were 83.3% Hispanic and 56.3% monolingual Spanish speakers, and 72.6% of mothers had not graduated high school. We found a significant (P = 0.05) intervention effect for parent proxy-reported child generic (but not asthma-specific) HRQOL, with CC + PST superior to SC [83.8 vs 79.8; adjusted mean difference of 4.05 points (95% confidence interval 0.63-7.4], but no difference between the CC and SC groups.
CONCLUSIONS


In this sample of vulnerable families of children with persistent asthma, a CC + PST intervention was efficacious in improving children's generic HRQOL.",2010,"We found a significant (P = 0.05) intervention effect for parent proxy-reported child generic (but not asthma-specific) HRQOL, with CC + PST superior to SC [83.8 vs 79.8; adjusted mean difference of 4.05 points (95% confidence interval 0.63-7.4], but no difference between the CC and SC groups.
","['children with persistent asthma from predominantly lower socioeconomic status (SES) Spanish-speaking Hispanic families', 'vulnerable families of children with persistent asthma', 'Participants (n = 252) were 83.3% Hispanic and 56.3% monolingual Spanish speakers, and 72.6% of mothers had not graduated high school']","['CC + PST intervention', 'standard care waitlist (SC) control, home-visiting asthma education/care coordination (CC), and combined intervention (CC + PST', 'Problem-solving skills training', 'problem-solving skill training (PST']","['health-related quality of life (HRQOL', 'parent proxy-report child HRQOL (PedsQL', ""children's generic HRQOL""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C1679754', 'cui_str': 'Asthma education (procedure)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",252.0,0.0577477,"We found a significant (P = 0.05) intervention effect for parent proxy-reported child generic (but not asthma-specific) HRQOL, with CC + PST superior to SC [83.8 vs 79.8; adjusted mean difference of 4.05 points (95% confidence interval 0.63-7.4], but no difference between the CC and SC groups.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Seid', 'Affiliation': 'Division of Pulmonary Medicine, Cincinnati Children’s Hospital Medical Center, USA. michael.seid@cchmc.org'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Varni', 'Affiliation': ''}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Gidwani', 'Affiliation': ''}, {'ForeName': 'Leticia Reyes', 'Initials': 'LR', 'LastName': 'Gelhard', 'Affiliation': ''}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Slymen', 'Affiliation': ''}]",Journal of pediatric psychology,['10.1093/jpepsy/jsp133']
901,18461212,"Effects of a 12-week exercise training programme on aerobic fitness, body composition, blood lipids and C-reactive protein in adolescents with obesity.","INTRODUCTION


Developing effective exercise programmes for the paediatric population is a strategy for decreasing obesity and is expected to help in eventually limiting obesity-associated long-term health and societal impact. In this study, the effects of a 12-week twice weekly additional exercise training, which comprised a combination of circuit-based resistance training and aerobic exercises, in additional to typical physical education sessions, on aerobic fitness, body composition and serum C-reactive protein (CRP) and lipids were analysed in 13- to 14-year-old obese boys contrasted with a control group.
MATERIALS AND METHODS


Both the exercise group (EG, n = 12) and control group (CG, n = 12) participated in the typical 2 sessions of 40-minute physical education (PE) per week in schools, but only EG participated in additional 2 sessions per week of 45 to 60 minutes per session of exercise training, which comprised a combination of circuit-based resistance training and aerobic exercises maintained at 65% to 85% maximum heart rate (HRmax = 220 - age). Body composition was measured using dual energy X-ray absorptiometry (DEXA). Fasting serum CRP and blood lipids were analysed pre- and postexercise programme. Aerobic fitness was measured by an objective laboratory submaximal exercise test, PWC170 (Predicted Work Capacity at HR 170 bpm).
RESULTS


Exercise training significantly improved lean muscle mass, body mass index, fitness, resting HR, systolic blood pressure and triglycerides in EG. Serum CRP concentrations were elevated at baseline in both groups, but training did not result in a change in CRP levels. In the CG, body weight increased significantly at the end of the 12-week period.
CONCLUSION


This study supports the value of an additional exercise training programme, beyond the typical twice weekly physical education classes, to produce physiological benefits in the management of obesity in adolescents, including prevention of weight gain.",2008,"RESULTS


Exercise training significantly improved lean muscle mass, body mass index, fitness, resting HR, systolic blood pressure and triglycerides in EG.","['13- to 14-year-old obese boys contrasted with a control group', 'adolescents with obesity']","['additional exercise training', 'circuit-based resistance training and aerobic exercises', 'additional exercise training programme', 'exercise training programme', 'Exercise training', 'control group (CG, n = 12) participated in the typical 2 sessions of 40-minute physical education (PE) per week in schools, but only EG participated in additional 2 sessions per week of 45 to 60 minutes per session of exercise training, which comprised a combination of circuit-based resistance training and aerobic exercises']","['Body composition', 'aerobic fitness, body composition, blood lipids and C-reactive protein', 'Serum CRP concentrations', 'Fasting serum CRP and blood lipids', 'lean muscle mass, body mass index, fitness, resting HR, systolic blood pressure and triglycerides in EG', 'body weight', 'objective laboratory submaximal exercise test, PWC170 (Predicted Work Capacity at HR 170 bpm', 'CRP levels', 'Aerobic fitness', 'aerobic fitness, body composition and serum C-reactive protein (CRP) and lipids']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",12.0,0.0185572,"RESULTS


Exercise training significantly improved lean muscle mass, body mass index, fitness, resting HR, systolic blood pressure and triglycerides in EG.","[{'ForeName': 'Patricia C H', 'Initials': 'PC', 'LastName': 'Wong', 'Affiliation': 'Physical Education & Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore. pat.wong@nie.edu.sg'}, {'ForeName': 'Michael Y H', 'Initials': 'MY', 'LastName': 'Chia', 'Affiliation': ''}, {'ForeName': 'Ian Y Y', 'Initials': 'IY', 'LastName': 'Tsou', 'Affiliation': ''}, {'ForeName': 'Gervais K L', 'Initials': 'GK', 'LastName': 'Wansaicheong', 'Affiliation': ''}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'John C K', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Chung Gon', 'Initials': 'CG', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Boh', 'Affiliation': ''}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
902,32432553,Midwives' Attitudes Toward and Experience With a Tablet Intervention to Promote Safety Behaviors for Pregnant Women Reporting Intimate Partner Violence: Qualitative Study.,"BACKGROUND


Violence against women is considered a global health problem, and intimate partner violence (IPV) around the time of childbirth can have severe consequences for mother and child. Prenatal care is considered a window of opportunity to address IPV and ask women about exposure to violence since women are in regular contact with health care providers. Mobile health (mHealth) interventions might overcome the barriers to talking about IPV face-to-face.
OBJECTIVE


Our objective was to explore midwives' attitudes toward a tablet intervention consisting of information about IPV and safety behaviors as well as their experiences with recruiting pregnant women of different ethnic backgrounds in a randomized controlled trial (RCT).
METHODS


Individual interviews were conducted with 9 midwives who recruited participants for an RCT to test a video to promote safety behaviors delivered on a tablet during prenatal care. Analysis was guided by thematic analysis.
RESULTS


Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors. They participated in the RCT primarily to obtain more knowledge regarding how to communicate about IPV. The intervention was perceived as an anonymous door-opener to talk about IPV and a good solution to ensure that every woman gets the same information. However, the content of the intervention had to be trustworthy and align with the information the midwives provide to women. Given the sensitivity of IPV, midwives outlined the importance of following the intervention with face-to-face communication. Midwives reported technical problems and a high demand on their time as the main challenges to recruiting women. They experienced challenges recruiting women of different ethnic backgrounds due to linguistic barriers and the women's skepticism about scientific research.
CONCLUSIONS


The tablet intervention might help midwives communicate about IPV. Although the video was considered as an anonymous door-opener to talk about IPV, midwives outlined the importance of following the intervention with face-to-face communication. The scarcity of midwives' time during consultations has to be considered when implementing the intervention. Further research is needed to overcome barriers that limit inclusion of women from different ethnic backgrounds.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03397277; https://clinicaltrials.gov/ct2/show/NCT03397277.",2020,"RESULTS


Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors.","['Violence against women', 'Individual interviews were conducted with 9 midwives who recruited participants for an', 'Pregnant Women Reporting Intimate Partner Violence']","['Tablet Intervention', 'RCT to test a video to promote safety behaviors delivered on a tablet during prenatal care', 'Mobile health (mHealth) interventions']",[],"[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]",[],9.0,0.0527447,"RESULTS


Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Garnweidner-Holme', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Henriksen', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Eva Marie', 'Initials': 'EM', 'LastName': 'Flaathen', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Klette Bøhler', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Lukasse', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}]",JMIR mHealth and uHealth,['10.2196/16828']
903,19652851,Prospective randomised study of intra-articular fractures of the distal radius: comparison between external fixation and plate fixation.,"INTRODUCTION


Intra-articular fractures of the distal radius represent high energy, complex, unstable injuries and the optimal method of treatment remains controversial.
MATERIALS AND METHODS


The aim of the paper is to compare the outcomes of external fixation (EF) with open reduction internal fixation (ORIF) with plates and screw fixation in the treatment of intra-articular fractures of the distal radius. Thirty-five patients were enlisted from December 2003 to September 2005 after a failure of initial conservative treatment. The patients were randomised into EF or ORIF groups. The patients were followed-up at 1 week, 3, 6, 12 and 24 months. Clinical and radiological outcomes were measured. They were scored using the Green and O'Brien or the Gartland and Wertley score.
RESULTS


Of the 35 patients, 5 defaulted the 6-month follow-up and were excluded. We found that the clinical and radiological outcomes for the 2 groups were not significantly different. Complication rates were also similar.
CONCLUSION


There is no significant difference in the outcome of intra-articular distal radius fractures treated with either EF or ORIF.",2009,There is no significant difference in the outcome of intra-articular distal radius fractures treated with either EF or ORIF.,"['Of the 35 patients, 5 defaulted the 6-month follow-up and were excluded', 'intra-articular fractures of the distal radius', 'Thirty-five patients were enlisted from December 2003 to September 2005 after a failure of initial conservative treatment']","['EF or ORIF', 'external fixation (EF) with open reduction internal fixation (ORIF) with plates and screw fixation', 'external fixation and plate fixation']","['outcome of intra-articular distal radius fractures', 'Complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332715', 'cui_str': 'Intraarticular Fractures'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",35.0,0.0164102,There is no significant difference in the outcome of intra-articular distal radius fractures treated with either EF or ORIF.,"[{'ForeName': 'Germaine G Q', 'Initials': 'GG', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedic Surgery, Tan Tock Seng Hospital, Singapore. germainexu@gmail.com'}, {'ForeName': 'Siew Pang', 'Initials': 'SP', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Mark Edward', 'Initials': 'ME', 'LastName': 'Puhaindran', 'Affiliation': ''}, {'ForeName': 'Winston Y C', 'Initials': 'WY', 'LastName': 'Chew', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
904,18392313,The Tao of bao: a randomised controlled trial examining the effect of steamed bun consumption on night-call inpatient course and mortality.,"BACKGROUND


Medical superstitions remain prevalent in today's stressful and technology driven healthcare environment. These irrational beliefs commonly involve night calls, which are periods of volatile workload. In Singapore and Hong Kong, it is commonly held that consumption of steamed buns (""bao"") by on-call physicians is associated with increased patient admissions and mortality, due to a homonymous interpretation of the word ""bao"" in dialect.
MATERIALS AND METHODS


A prospective unblinded randomised controlled trial with a permuted block randomisation design was performed on weekdays over 6 weeks. Steamed buns or control food were offered to the internal medicine night-call team of a tertiary-care hospital on a nightly basis. Information on admissions and mortality was collected from the hospital electronic database. Data on sleep patterns and shift duration were obtained by interview.
RESULTS


There were no significant differences in the median number of hours slept on days on ""bao"" administration versus ""control"" intervention (2 +/- median absolute variation of 1.5 h vs 2 +/- 1.5 h, P = 0.30) or in the number of hours spent in the hospital (30.8 +/- 1.9 h vs 30.5 +/- 2.2 h, P = 0.09). There were no significant differences in the median number of general ward admissions per night (n = 73 +/- 6 versus 71 +/- 7 admissions, P = 0.35), monitored care unit admissions (4 +/- 1.5 vs 4 +/- 1.5 admissions, P = 0.65) or inpatient mortality (2 +/- 1.5 vs 2 +/- 1.5 deaths per night, P = 0.47).
CONCLUSION


The consumption of steamed buns (""bao"") has no effect on inpatient admissions, mortality, or sleep duration on call. Regardless, our results indicate that the night call in Singapore remains a challenge in terms of workload and shift duration.",2008,"The consumption of steamed buns (""bao"") has no effect on inpatient admissions, mortality, or sleep duration on call.",[],"['steamed bun consumption', 'control"" intervention']","['median number of general ward admissions per night', 'night-call inpatient course and mortality', 'sleep patterns and shift duration', 'median number of hours slept', 'number of hours spent in the hospital', 'inpatient mortality', 'admissions and mortality']",[],"[{'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.0451399,"The consumption of steamed buns (""bao"") has no effect on inpatient admissions, mortality, or sleep duration on call.","[{'ForeName': 'Min-Han', 'Initials': 'MH', 'LastName': 'Tan', 'Affiliation': 'Department of Medical Oncology, National Cancer Centre, 11 Hospital Drive, Singapore. tan.min.han@nccs.com.sg'}, {'ForeName': 'Ziying', 'Initials': 'Z', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Eng Swen', 'Initials': 'ES', 'LastName': 'Sim', 'Affiliation': ''}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Chua', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tien', 'Affiliation': ''}, {'ForeName': 'Choon Jin', 'Initials': 'CJ', 'LastName': 'Ooi', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
905,31455824,"Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.",,2019,,['preterm infants'],"['placebo', 'Morphine']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.11121,,"[{'ForeName': 'Omri David', 'Initials': 'OD', 'LastName': 'Soffer', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA. Omri.soffer@childrens.harvard.edu.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelissen', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Berde', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0476-9']
906,29794146,Phase 3 results for vosaroxin/cytarabine in the subset of patients ≥60 years old with refractory/early relapsed acute myeloid leukemia.,,2018,,['patients ≥60 years old with refractory/early relapsed acute myeloid leukemia'],['vosaroxin/cytarabine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C1451341', 'cui_str': 'vosaroxin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]",[],,0.0213071,,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA fravandi@mdanderson.org.'}, {'ForeName': 'Ellen K', 'Initials': 'EK', 'LastName': 'Ritchie', 'Affiliation': 'Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Sayar', 'Affiliation': 'Indiana University Simon Cancer Center, Indianapolis, IN, USA.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Lancet', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Craig', 'Affiliation': 'West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Vey', 'Affiliation': 'Institut Paoli-Calmettes and Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Strickland', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Schiller', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Pigneux', 'Affiliation': 'Université de Bordeaux, Centre Hospitalier Universitaire de Bordeaux, France.'}, {'ForeName': 'Heinz-August', 'Initials': 'HA', 'LastName': 'Horst', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Récher', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III, Centre Hospitalier Universitaire de Toulouse, France.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Klimek', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Angelo-Michele', 'Initials': 'AM', 'LastName': 'Carella', 'Affiliation': 'IRCCS AOU San Martino-IST, Genova, Italy.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Kaposi Mor Teaching Hospital, Kaposvar, Hungary.'}, {'ForeName': 'Utz', 'Initials': 'U', 'LastName': 'Krug', 'Affiliation': 'Universitätsklinikum Münster, Germany.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Fox', 'Affiliation': 'Sunesis Pharmaceuticals, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Craig', 'Affiliation': 'Sunesis Pharmaceuticals, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Ward', 'Affiliation': 'Sunesis Pharmaceuticals, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Sunesis Pharmaceuticals, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Acton', 'Affiliation': 'Sunesis Pharmaceuticals, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Stuart', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",Haematologica,['10.3324/haematol.2018.191361']
907,31630567,Comparison of methods for control allocation in multiple arm studies using response adaptive randomization.,"BACKGROUND/AIMS


Response adaptive randomization has many polarizing properties in two-arm settings comparing control to a single treatment. The generalization of these features to the multiple arm setting has been less explored, and existing comparisons in the literature reach disparate conclusions. We investigate several generalizations of two-arm response adaptive randomization methods relating to control allocation in multiple arm trials, exploring how critiques of response adaptive randomization generalize to the multiple arm setting.
METHODS


We perform a simulation study to investigate multiple control allocation schemes within response adaptive randomization, comparing the designs on metrics such as power, arm selection, mean square error, and the treatment of patients within the trial.
RESULTS


The results indicate that the generalization of two-arm response adaptive randomization concerns is variable and depends on the form of control allocation employed. The concerns are amplified when control allocation may be reduced over the course of the trial but are mitigated in the methods considered when control allocation is maintained or increased during the trial. In our chosen example, we find minimal advantage to increasing, as opposed to maintaining, control allocation; however, this result reflects an extremely limited exploration of methods for increasing control allocation.
CONCLUSION


Selection of control allocation in multiple arm response adaptive randomization has a large effect on the performance of the design. Some disparate comparisons of response adaptive randomization to alternative paradigms may be partially explained by these results. In future comparisons, control allocation for multiple arm response adaptive randomization should be chosen to keep in mind the appropriate match between control allocation in response adaptive randomization and the metric or metrics of interest.",2020,The results indicate that the generalization of two-arm response adaptive randomization concerns is variable and depends on the form of control allocation employed.,[],[],[],[],[],[],,0.0696806,The results indicate that the generalization of two-arm response adaptive randomization concerns is variable and depends on the form of control allocation employed.,"[{'ForeName': 'Kert', 'Initials': 'K', 'LastName': 'Viele', 'Affiliation': 'Berry Consultants LLC, Austin, TX, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Berry Consultants LLC, Austin, TX, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants LLC, Austin, TX, USA.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants LLC, Austin, TX, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519877836']
908,32428202,The work of older people and their informal caregivers in managing an acute health event in a hospital at home or hospital inpatient setting.,"BACKGROUND


There is limited understanding of the contribution made by older people and their caregivers to acute healthcare in the home and how this compares to hospital inpatient healthcare.
OBJECTIVES


To explore the work of older people and caregivers at the time of an acute health event, the interface with professionals in a hospital and hospital at home (HAH) and how their experiences relate to the principles underpinning comprehensive geriatric assessment (CGA).
DESIGN


A qualitative interview study within a UK multi-site participant randomised trial of geriatrician-led admission avoidance HAH, compared with hospital inpatient care.
METHODS


We conducted semi-structured interviews with 34 older people (15 had received HAH and 19 hospital care) alone or alongside caregivers (29 caregivers; 12 HAH, 17 hospital care), in three sites that recruited participants to a randomised trial, during 2017-2018. We used normalisation process theory to guide our analysis and interpretation of the data.
RESULTS


Patients and caregivers described efforts to understand changes in health, interpret assessments and mitigate a lack of involvement in decisions. Practical work included managing risks, mobilising resources to meet health-related needs, and integrating the acute episode into longer-term strategies. Personal, relational and environmental factors facilitated or challenged adaptive capacity and ability to manage.
CONCLUSIONS


Patients and caregivers contributed to acute healthcare in both locations, often in parallel to healthcare providers. Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.",2020,"Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.","['34 older people (15 had received HAH and 19 hospital care) alone or alongside caregivers (29 caregivers; 12 HAH, 17 hospital care), in three sites that recruited participants to a randomised trial, during 2017-2018', 'older people and their informal caregivers in managing an acute health event in a hospital at home or hospital inpatient setting', 'older people and caregivers at the time of an acute health event, the interface with professionals in a hospital and hospital at home (HAH']",['geriatrician-led admission avoidance HAH'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0586872', 'cui_str': 'Geriatrics specialist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],,0.105641,"Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Mäkelä', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': 'Monklands Hospital, NHS Lanarkshire, Glasgow, UK.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Schiff', 'Affiliation': ""Department of Ageing and Health, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Shepperd', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",Age and ageing,['10.1093/ageing/afaa085']
909,18695765,"Immunogenicity, reactogenicity and safety of a diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus influenzae type b vaccine in a placebo-controlled rotavirus vaccine study.","INTRODUCTION


In recent years, acellular pertussis combination vaccines have facilitated compliance with and coverage of the national immunisation programme in Singapore. This phase-II study (Rota-007) evaluated the immunogenicity, reactogenicity and safety of a DTPa-IPV/Hib combined vaccine when co-administered with a rotavirus vaccine.
MATERIALS AND METHODS


A total of 2464 children aged 3 months were vaccinated with DTPa-IPV/Hib together with a randomised 1:3 ratio of either placebo (n=653) or 1 of 3 different formulations of a rotavirus vaccine. Blood samples were collected for immunogenicity analysis 1 month after the third DTPa-IPV/Hib vaccine dose in a subset of subjects (n = 640). Local and general reactogenicity and unsolicited adverse events were recorded during the follow-up after each vaccination.
RESULTS


Serological analysis showed >95% response for all antigens in the co-administered DTPa-IPV/Hib vaccine, with no difference between the rotavirus vaccine and placebo groups. No differences in adverse events and reactogenicity were reported in the rotavirus vaccine and placebo groups. Only 0.2% of the subjects reported Grade 3 adverse events. Three subjects (from the vaccine groups) died during the study, which were assessed by the investigators as unrelated to vaccination. No deaths were reported in the placebo group.
CONCLUSION


The combined DTPa- IPV/Hib vaccine is safe, well tolerated and highly immunogenic when given alone or coadministered with the rotavirus vaccine for infants in Singapore.",2008,No differences in adverse events and reactogenicity were reported in the rotavirus vaccine and placebo groups.,"['infants in Singapore', '2464 children aged 3 months were vaccinated with DTPa-IPV/Hib together with a randomised 1:3 ratio of either', 'Singapore']","['rotavirus vaccine', 'placebo', 'DTPa-IPV/Hib combined vaccine', 'diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus influenzae type b vaccine']","['deaths', 'Grade 3 adverse events', 'adverse events and reactogenicity', 'immunogenicity, reactogenicity and safety', 'Immunogenicity, reactogenicity and safety', 'Local and general reactogenicity and unsolicited adverse events']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013254', 'cui_str': 'Pentetic Acid'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013254', 'cui_str': 'Pentetic Acid'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0062086', 'cui_str': 'Haemophilus influenzae type b polyribosylribitol phosphate capsular polysaccharide vaccine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",2464.0,0.194663,No differences in adverse events and reactogenicity were reported in the rotavirus vaccine and placebo groups.,"[{'ForeName': 'Kong Boo', 'Initials': 'KB', 'LastName': 'Phua', 'Affiliation': ""Department of Paediatrics, KK Women's and Children's Hospital, National University Hospital, Singapore. phua.kong.boo@kkh.com.sg""}, {'ForeName': 'Seng Hock', 'Initials': 'SH', 'LastName': 'Quak', 'Affiliation': ''}, {'ForeName': 'Fong Seng', 'Initials': 'FS', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goh', 'Affiliation': ''}, {'ForeName': 'Yee Leong', 'Initials': 'YL', 'LastName': 'Teoh', 'Affiliation': ''}, {'ForeName': 'Sanjoy Kumar', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': ''}, {'ForeName': 'Htay Htay', 'Initials': 'HH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Hans Ludwig', 'Initials': 'HL', 'LastName': 'Bock', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
910,31880965,Value of Biomarker Expression for Randomized Clinical Trial Design: One (More) Missed Opportunity.,,2020,,[],[],[],[],[],[],,0.076184,,"[{'ForeName': 'Francisco E', 'Initials': 'FE', 'LastName': 'Vera-Badillo', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Robinson', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Berman', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Booth', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02393']
911,18797562,Hypnotherapy for sleep disorders.,"Hypnosis can be defined as a procedure during which changes in sensations, perceptions, thoughts, feelings or behaviour are suggested. Hypnosis can be used to amplify whatever it is about therapy that makes it therapeutic. It permits a wide range of choices regarding where and how to intervene in the patient's problems. In this paper, we set out to examine the rationale of using hypnotherapy to manage various types of sleep disorders, and to explore the techniques, strategies and hypnotic scripts employed by various hypnotherapists. We also examine the research data available on the efficacy of hypnosis in the treatment of sleep disorders. Acute and chronic insomnia often respond to relaxation and hypnotherapy approaches, along with sleep hygiene instructions. Hypnotherapy has also helped with nightmares and sleep terrors. There are several reports of successful use of hypnotherapy for parasomnias, specifically for head and body rocking, bedwetting and sleepwalking. Hypnosis is a specialised technique, not a therapy itself, and should be used as an adjunctive intervention within a complete psychological and medical treatment package. Most of the literature is limited to case reports or studies with such a small sample that at times it is very difficult to interpret the results. There is a major placebo effect, so uncontrolled trials are of limited value. It is hard to perform a randomised, double-blind, controlled trial to evaluate hypnotherapy given that cooperation and rapport between patient and therapist is needed to achieve a receptive trance state.",2008,"Hypnosis can be defined as a procedure during which changes in sensations, perceptions, thoughts, feelings or behaviour are suggested.",['sleep disorders'],"['Hypnotherapy', 'hypnotherapy', 'hypnosis']",[],"[{'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}]",[],,0.0315245,"Hypnosis can be defined as a procedure during which changes in sensations, perceptions, thoughts, feelings or behaviour are suggested.","[{'ForeName': 'Beng-Yeong', 'Initials': 'BY', 'LastName': 'Ng', 'Affiliation': 'Department of Psychiatry, Singapore General Hospital, Singapore. ng.beng.yeong@sgh.com.sg'}, {'ForeName': 'Tih Shih', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
912,31837032,Can text messages save lives? A field experiment on blood donor motivation.,"BACKGROUND


Continuous effort around the globe is exerted into donor management, with the overall aim of keeping a constant flow of new donations. To achieve this goal, blood banks and blood donor associations are taking initiatives to get the same donor to make repeated donations. In general, such initiatives are implemented without proper evaluation. This study circumvents this trend and evaluates the effect on donations from sending blood donors a text message when their donation has helped a patient.
METHODS AND MATERIALS


In a large-scale field experiment (n = 20,365), we randomized donors such that half are sent a text message when their donation was used. Among those who were randomized to the text message, we also randomized the time of day the text message was sent.
RESULTS


The messages increased subsequent donations by 3.6% (p = 0.023), compared with donors who did not get the message. It was also shown that optimizing the time of day when the text messages were sent increased the effect substantially. Text messages sent in the evening increased donations by 6.5% (p = 0.011). Finally, it was found that, among whole blood donors, the text messages did not have a significant effect (p = 0.554), whereas it did among the plasma donors (p = 0.003).
CONCLUSION


Several blood banks have adopted the strategy of sending blood donors a text message that acknowledges that donors' contributions helped a patient. This study is the first to formally test the effects of such a message with a control group.",2020,"The messages increased subsequent donations by 3.6% (p = 0.023), compared with donors who did not get the message.",[],[],"['blood donor motivation', 'subsequent donations']",[],[],"[{'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]",,0.0305997,"The messages increased subsequent donations by 3.6% (p = 0.023), compared with donors who did not get the message.","[{'ForeName': 'Toke', 'Initials': 'T', 'LastName': 'Fosgaard', 'Affiliation': 'Department of Food and Resource Economics, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'Department of Food and Resource Economics, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Jacobsen', 'Affiliation': 'Bro Kommunikation, Esplanaden, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Sørensen', 'Affiliation': 'Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Romose', 'Affiliation': 'Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ullum', 'Affiliation': 'Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Transfusion,['10.1111/trf.15633']
913,31919898,"RE: Aliuskevicius M, Ostgaard SE, Hauge EM, et al. 2019. Influence of ibuprofen on bone healing after Colles' fracture: A randomized controlled clinical trial.",,2020,,"[""after Colles' fracture""]",['ibuprofen'],['bone healing'],"[{'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",,0.051282,,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Starlinger', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Balls-Berry', 'Affiliation': 'Department of Education, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Amadio', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Rochester, Rochester, Minnesota.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24582']
914,31904166,A Three-Dimensional Print Model of the Pterygopalatine Fossa Significantly Enhances the Learning Experience.,"The pterygopalatine fossa (PPF) is a bilateral space deep within the skull that serves as a major neurovascular junction. However, its small volume and poor accessibility make it a difficult space to comprehend using two-dimensional illustrations and cadaveric dissections. A three-dimensional (3D) printed model of the PPF was developed as a visual and kinesthetic learning tool for completely visualizing the fossa, its boundaries, its communicating channels, and its neurovascular structures. The model was evaluated by analyzing student performance on pre- and post-quizzes and a student satisfaction survey based on the five-point Likert scale. The first cohort comprised of 88 students who had never before studied the PPF. The second cohort consisted of 30 students who were previously taught the PPF. Each cohort was randomly divided into a control group who were provided with a half skull and an intervention group that were provided with the 3D printed model. The intervention group performed significantly better on the post-quiz as compared to the control group in cohort I (P = 0.001); while not significant, it also improved learning in cohort II students (P = 0.124). Satisfaction surveys indicated that the intervention group found the 3D printed model to be significantly more useful (P < 0.05) as compared to the half skull used by the control group. Importantly, the effect sizes for cohorts I and II (0.504 and 0.581, respectively) validated the statistical results. Together, this study highlights the importance of 3D printed models as teaching tools in anatomy education.",2020,Satisfaction surveys indicated that the intervention group found the 3D printed model to be significantly more useful (P <0.05) as compared to the half-skull used by the control group.,"['30 students who were previously taught the PPF', '88 students who had never before studied the PPF']","['Pterygopalatine Fossa', 'pterygopalatine fossa (PPF']","['Satisfaction surveys', 'Learning Experience']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0230039', 'cui_str': 'Pterygopalatine Fossa'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0132403,Satisfaction surveys indicated that the intervention group found the 3D printed model to be significantly more useful (P <0.05) as compared to the half-skull used by the control group.,"[{'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Tanner', 'Affiliation': 'Department of Cell Systems and Anatomy, Long School of Medicine, UT Health, San Antonio, Texas.'}, {'ForeName': 'Beeran', 'Initials': 'B', 'LastName': 'Jethwa', 'Affiliation': 'Department of Cell Systems and Anatomy, Long School of Medicine, UT Health, San Antonio, Texas.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': 'Office of Undergraduate Medical Education, Long School of Medicine, UT Health, San Antonio, Texas.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bartanuszova', 'Affiliation': 'Department of Cell Systems and Anatomy, Long School of Medicine, UT Health, San Antonio, Texas.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'King', 'Affiliation': 'Department of Cell Systems and Anatomy, Long School of Medicine, UT Health, San Antonio, Texas.'}, {'ForeName': 'Arunabh', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Clinical and Applied Sciences Education, School of Osteopathic Medicine, University of Incarnate Word, San Antonio, Texas.'}, {'ForeName': 'Ramaswamy', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Cell Systems and Anatomy, Long School of Medicine, UT Health, San Antonio, Texas.'}]",Anatomical sciences education,['10.1002/ase.1942']
915,32431275,Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial.,"A cluster-randomized, double-blinded, placebo-controlled trial was conducted to estimate the protective efficacy (PE) of a spatial repellent (SR) against malaria infection in Sumba, Indonesia. Following radical cure in 1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given transfluthrin or placebo passive emanators (devices designed to release vaporized chemical). Monthly blood screening and biweekly human-landing mosquito catches were performed during a 10-month baseline (June 2015-March 2016) and a 24-month intervention period (April 2016-April 2018). Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households. The 24-cluster protective effect of 27.7% and 31.3%, for time to first-event and overall (total new) infections, respectively, was not statistically significant. Purportedly, this was due in part to zero to low incidence in some clusters, undermining the ability to detect a protective effect. Subgroup analysis of 19 clusters where at least one infection occurred during baseline showed 33.3% ( P -value = 0.083) and 40.9% ( P -value = 0.0236, statistically significant at the one-sided 5% significance level) protective effect to first infection and overall infections, respectively. Among 12 moderate- to high-risk clusters, a statistically significant decrease in infection by intervention was detected (60% PE). Primary entomological analysis of impact was inconclusive. Although this study suggests SRs prevent malaria, additional evidence is required to demonstrate the product class provides an operationally feasible and effective means of reducing malaria transmission.",2020,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","['Control of Malaria in Indonesia', '1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given', '667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households']","['transfluthrin or placebo passive emanators (devices designed to release vaporized chemical', 'Monthly blood screening and biweekly human-landing mosquito catches', 'placebo']","['infection by intervention', 'protective efficacy (PE', '24-cluster protective effect', 'time to first-event and overall (total new) infections']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3178479', 'cui_str': 'transfluthrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086137', 'cui_str': 'Device Design'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205314', 'cui_str': 'New'}]",1341.0,0.277179,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","[{'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Puji B S', 'Initials': 'PBS', 'LastName': 'Asih', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Ismail Ekoprayitno', 'Initials': 'IE', 'LastName': 'Rozi', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Dendi Hadi', 'Initials': 'DH', 'LastName': 'Permana', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Anggi Puspa', 'Initials': 'AP', 'LastName': 'Nur Hidayati', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Lepa', 'Initials': 'L', 'LastName': 'Syahrani', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Zubaidah', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Sidik', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bangs', 'Affiliation': 'Public Health and Malaria Control, PT Freeport Indonesia, International SOS, Kuala Kencana, Papua, Indonesia.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bøgh', 'Affiliation': 'The Sumba Foundation, Public Health and Malaria Control, Bali, Indonesia.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Applied and Computational Mathematics and Statistics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Evercita C', 'Initials': 'EC', 'LastName': 'Eugenio', 'Affiliation': 'Department of Applied and Computational Mathematics and Statistics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Hendrickson', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'J Kevin', 'Initials': 'JK', 'LastName': 'Baird', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Collins', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Grieco', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Neil F', 'Initials': 'NF', 'LastName': 'Lobo', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Achee', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0554']
916,31789564,Supporting strategic processes can improve time-based prospective memory in the laboratory among older adults with HIV disease.,"OBJECTIVE


Older adults with HIV disease demonstrate moderate deficits in time-based prospective memory (PM), which is the strategically demanding ability of remembering to perform a task at a specific time. Using theories from the PM literature, we hypothesized that supporting strategic processes would improve time-based PM in the laboratory among HIV+ older adults.
METHOD


One hundred forty-five HIV+ participants were randomly assigned to a control condition or an experimental group in which strategic processing was supported at encoding (i.e., implementation intentions and visualization), monitoring (i.e., content-free cuing), and/or cue detection (i.e., auditory alarm). The HIV+ control group and 58 seronegative participants completed two ongoing language tasks with a time-based PM requirement. The HIV+ experimental groups underwent counterbalanced time-based PM trials under both control and strategically supported conditions.
RESULTS


The HIV+ cue-detection group showed a large within-subjects improvement, which was strongly related to lower scores on separate clinical time-based PM measure and was accompanied by a large reduction in clock-checking behavior. Results also revealed a small within-subjects improvement in time-based PM in the encoding condition.
CONCLUSIONS


Supporting strategic encoding and cue-detection processes in the laboratory can improve time-based PM deficits in older HIV+ adults, which may inform the development of more naturalistic PM-based interventions to enhance health behaviors. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,The HIV+ control group and 58 seronegative participants completed two ongoing language tasks with a time-based PM requirement.,"['HIV+ older adults', '58 seronegative participants completed two', 'One hundred forty-five', 'HIV+ participants', 'older HIV+ adults', 'older adults with HIV disease', 'Older adults with HIV disease demonstrate moderate deficits in time-based prospective memory (PM']","['ongoing language tasks with a time-based PM requirement', 'control condition or an experimental group in which strategic processing was supported at encoding (i.e., implementation intentions and visualization), monitoring (i.e., content-free cuing), and/or cue detection (i.e., auditory alarm']",['time-based PM'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0589154', 'cui_str': 'Memory, Prospective'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",2019.0,0.0351675,The HIV+ control group and 58 seronegative participants completed two ongoing language tasks with a time-based PM requirement.,"[{'ForeName': 'Steven Paul', 'Initials': 'SP', 'LastName': 'Woods', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry, University of California, San Diego.'}, {'ForeName': 'Shayne', 'Initials': 'S', 'LastName': 'Loft', 'Affiliation': 'School of Psychological Science, University of Western Australia.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Matchanova', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'Marizela', 'Initials': 'M', 'LastName': 'Verduzco', 'Affiliation': 'Department of Psychiatry, University of California, San Diego.'}, {'ForeName': 'Clint', 'Initials': 'C', 'LastName': 'Cushman', 'Affiliation': 'Department of Psychiatry, University of California, San Diego.'}]",Neuropsychology,['10.1037/neu0000602']
917,31692233,Coherence principles in interval-based dose finding.,"This paper studies the notion of coherence in interval-based dose-finding methods. An incoherent decision is either (a) a recommendation to escalate the dose following an observed dose-limiting toxicity or (b) a recommendation to deescalate the dose following a non-dose-limiting toxicity. In a simulated example, we illustrate that the Bayesian optimal interval method and the Keyboard method are not coherent. We generated dose-limiting toxicity outcomes under an assumed set of true probabilities for a trial of n=36 patients in cohorts of size 1, and we counted the number of incoherent dosing decisions that were made throughout this simulated trial. Each of the methods studied resulted in 13/36 (36%) incoherent decisions in the simulated trial. Additionally, for two different target dose-limiting toxicity rates, 20% and 30%, and a sample size of n=30 patients, we randomly generated 100 dose-toxicity curves and tabulated the number of incoherent decisions made by each method in 1000 simulated trials under each curve. For each method studied, the probability of incurring at least one incoherent decision during the conduct of a single trial is greater than 75%. Coherency is an important principle in the conduct of dose-finding trials. Interval-based methods violate this principle for cohorts of size 1 and require additional modifications to overcome this shortcoming. Researchers need to take a closer look at the dose assignment behavior of interval-based methods when using them to plan dose-finding studies.",2020,Researchers need to take a closer look at the dose assignment behavior of interval-based methods when using them to plan dose-finding studies.,['n=36 patients in cohorts of size 1'],[],['toxicity rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",[],"[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",1000.0,0.14379,Researchers need to take a closer look at the dose assignment behavior of interval-based methods when using them to plan dose-finding studies.,"[{'ForeName': 'Nolan A', 'Initials': 'NA', 'LastName': 'Wages', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Iasonos', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Quigley"", 'Affiliation': 'LPSM, INSERM, Sorbonne University, Paris, France.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}]",Pharmaceutical statistics,['10.1002/pst.1974']
918,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND


Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
METHODS


We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
RESULTS


We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
CONCLUSION


It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026']
919,17987229,Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine.,"INTRODUCTION


Children in Singapore receive vaccination against hepatitis B virus (HBV) at 0, 1 and 5 or 6 months of age, and vaccination against pertussis, diphtheria, tetanus, and polio at 3, 4 and 5 months of age. Parents often choose to vaccinate with the combined acellular-pertussis-inactivated polio-Hib vaccine (DTPa-IPV/Hib). We investigated whether a combined hexavalent vaccine, DTPa-HBV-IPV/Hib, could replace the separate administration of DTPa-IPV/Hib and HBV for the final vaccination at 5 months of age (Trial DTPa-HBV-IPV-075).
MATERIALS AND METHODS


In an open study, 150 children were randomised to complete their vaccination schedule with DTPa-IPV/Hib + HBV or DTPa-HBV-IPV/Hib.
RESULTS


One month after the final vaccination, there was no difference between groups in seroprotection rates or antibody concentrations against HBV. Seroprotection rates against diphtheria, tetanus, Hib and polio, as well as vaccine response rates to pertussis antigens were also similar between groups. Local and general symptoms occurred at a similar rate after the third dose of either vaccine.
CONCLUSION


The immunogenicity and reactogenicity of the hexavalent vaccine DTPa-HBV-IPV/Hib (Infanrix hexa, GSK) group is comparable to that of separately administered DTPa-IPV/Hib and HBV vaccines. Combined hexavalent vaccine, DTPa-HBV-IPV/Hib, could replace the separate administration of DTPa-IPV/Hib and HBV for vaccination at 5 months of age, thereby reducing the number of injections required.",2007,"Seroprotection rates against diphtheria, tetanus, Hib and polio, as well as vaccine response rates to pertussis antigens were also similar between groups.","['infants against hepatitis B', '150 children']","['combined acellular-pertussis-inactivated polio-Hib vaccine (DTPa-IPV/Hib', 'Combined hexavalent vaccine, DTPa-HBV-IPV/Hib', 'combined hexavalent vaccine, DTPa-HBV-IPV/Hib', 'DTPa-IPV/Hib + HBV or DTPa-HBV-IPV/Hib', 'hexavalent vaccine DTPa-HBV-IPV/Hib (Infanrix hexa, GSK', 'hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine']","['immunogenicity and reactogenicity', 'Seroprotection rates against diphtheria, tetanus, Hib and polio', 'Local and general symptoms', 'seroprotection rates or antibody concentrations against HBV']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0062086', 'cui_str': 'Haemophilus influenzae type b polyribosylribitol phosphate capsular polysaccharide vaccine'}, {'cui': 'C0013254', 'cui_str': 'Pentetic Acid'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3661302', 'cui_str': 'Infanrix hexa'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}]","[{'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0159028', 'cui_str': 'General symptom (finding)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",150.0,0.0423381,"Seroprotection rates against diphtheria, tetanus, Hib and polio, as well as vaccine response rates to pertussis antigens were also similar between groups.","[{'ForeName': 'Fong Seng', 'Initials': 'FS', 'LastName': 'Lim', 'Affiliation': 'National Health Care Group Polyclinics, Choa Chu Kang, Singapore. Fong_Seng_LIM@nhgp.com.sg'}, {'ForeName': 'Htay-Htay', 'Initials': 'HH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Jacquet', 'Affiliation': ''}, {'ForeName': 'Hans L', 'Initials': 'HL', 'LastName': 'Bock', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
920,17483854,Risk factors of distress in Alzheimer's patients.,"INTRODUCTION


Distress of Alzheimer's disease (AD) contribute significantly to decreased quality of life, increased morbidity, higher levels of caregiver distress, and the decision to institutionalise a patient. However, the risk factors of distress in AD patients have not been thoroughly discussed. The aim of this study was to identify the risk factors of distress in AD patients.
MATERIALS AND METHODS


A large randomised controlled clinical trial on AD was analysed in this study. Both linear regression and decision tree models were used to identify the factors of distress in AD patients.
RESULTS


The following variables were recognised as risk factors for AD patient's distress: Care recipients often visit physicians or have medical examinations; Care recipients take medicines that affect the central nervous system or stomach; Care recipients seldom visit nurses; Caregivers have chronic disease or cancer; Caregiver experience distress, feel lonely, or have an unsatisfactory relationship with patients. In addition, caregiver's smoking and drinking were found to correlate negatively with AD patient's distress.
CONCLUSIONS


Multiple factors influence the distress of Alzheimer's patients, including patient's examination and medication, patient-caregiver relationships, caregiver's psychological and physical status, and the use of nursing services. These factors should be targeted when designing prevention and intervention strategies.",2007,The following variables were recognised as risk factors for AD patient's distress:,"[""Alzheimer's patients"", 'AD patients', 'Care recipients often visit physicians or have medical examinations; Care recipients']",[],"[""risk factors for AD patient's distress""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]",[],"[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0455358,The following variables were recognised as risk factors for AD patient's distress:,"[{'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Department of Neurology, The Shanghai First People's Hospital, Shanghai Jiaotong University, Shanghai, PR China. zhou_xiaolin@163.com""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yongbo', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
921,17483857,Effects of group psychoeducation (GPE) on compliance with scheduled clinic appointments in a neuro-psychiatric hospital in southwest Nigeria: a randomised control trial (RCT).,"INTRODUCTION


The aim of this study was to find out the effects of group psychoeducation (GPE) on the scheduled clinic appointments of patients admitted for psychosis and depression after discharge from hospital.
MATERIALS AND METHODS


A randomised controlled trial (RCT) of 4 sessions of GPE delivered while the patients were admitted was conducted and compared to no session of GPE with the usual care. This RCT was conducted in a 60-bed state reference neuropsychiatric hospital in Southwest of Nigeria. The study population consisted of 48 admitted patients for psychotic disorders, including schizophrenia and depression. Twenty-five patients admitted were randomly selected to undergo 4 sessions of GPE before discharge from hospital, and 23 patients were randomly selected to receive regular medication and care without undergoing GPE. Both groups were then followed for 9 months on clinic days to measure compliance with scheduled appointments. Main outcome was measured by the number of clinic appointments kept within the period of study after discharge from hospital.
RESULTS


Patients in the treatment group were consistently more compliant with scheduled clinic appointments than those in the experimental group (P = 0.0009, DF = 34; t-test at 95% CI). There was also no significant difference in compliance with visits among patients with different diagnoses (treatment group; P = 0.90, DF = 12, experimental group; P = 0.33, DF = 11).
CONCLUSION


GPE is effective in improving patients' compliance with scheduled clinic appointments after discharge for a period of 9 months. GPE can be used as part of treatment package for all psychiatric diagnoses and it has no age bias.",2007,"RESULTS


Patients in the treatment group were consistently more compliant with scheduled clinic appointments than those in the experimental group (P = 0.0009, DF = 34; t-test at 95% CI).","['scheduled clinic appointments of patients admitted for psychosis and depression after discharge from hospital', 'compliance with scheduled clinic appointments in a neuro-psychiatric hospital in southwest Nigeria', 'Twenty-five patients admitted were randomly selected to undergo 4 sessions of GPE before discharge from hospital, and 23 patients', '48 admitted patients for psychotic disorders, including schizophrenia and depression', '60-bed state reference neuropsychiatric hospital in Southwest of Nigeria']","['group psychoeducation (GPE', 'GPE', 'regular medication and care without undergoing GPE']","['compliant with scheduled clinic appointments', 'compliance with visits', 'number of clinic appointments kept']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",48.0,0.0316124,"RESULTS


Patients in the treatment group were consistently more compliant with scheduled clinic appointments than those in the experimental group (P = 0.0009, DF = 34; t-test at 95% CI).","[{'ForeName': 'Abiodun Jackson', 'Initials': 'AJ', 'LastName': 'Agara', 'Affiliation': 'Royal Oldham Hospital, Oldham, Lancashire, UK.'}, {'ForeName': 'Oluyemisi Evelyn', 'Initials': 'OE', 'LastName': 'Onibi', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
922,17483861,Pars plana vitrectomy and internal limiting membrane peeling for macular oedema secondary to retinal vein occlusion: a pilot study.,"INTRODUCTION


Macular oedema is the main cause of visual impairment following retinal vein occlusion. The purpose of this study was to evaluate the anatomical and functional outcome of pars plana vitrectomy and internal limited membrane (ILM) peeling for macular oedema secondary to retinal vein occlusion.
CLINICAL PICTURE


This pilot study is a prospective nonrandomised series of 11 eyes of 11 patients with macular oedema secondary to retinal vein occlusion. The best-corrected visual acuity (BCVA), foveal thickness on optical coherence tomography, fundus fluorescein angiography (FFA) and multifocal electroretinography were evaluated.
TREATMENT AND OUTCOME


All 11 patients underwent pars plana vitrectomy with ILM peeling. The mean postoperative follow-up was 13.5 months (range, 1.5 to 24). The mean thickness at the foveal centre decreased from 794 +/- 276 microm preoperatively to 373 +/- 150 microm, 302 +/- 119 microm, 249 +/- 203 microm and 185 +/- 66 microm at 1 week, 1 month, 3 months and the final visit postoperatively, respectively (all P <0.001, paired t- test, compared to preoperative thickness). Postoperative FFA demonstrated markedly reduced leakage in the macular region. At the final visit, BCVA improved 2 lines or more in 72.7% (8/11) of patients and was unchanged in 27.3% (3/11) patients. Complications included cataract in 7 patients and vitreous haemorrhage, recurrence of macular oedema and visual field defect in 1 case each.
CONCLUSION


Pars plana vitrectomy and ILM peeling rapidly reduced the macular oedema caused by retinal vein occlusion, with improvement in BCVA.",2007,"At the final visit, BCVA improved 2 lines or more in 72.7% (8/11) of patients and was unchanged in 27.3% (3/11) patients.","['203 microm and 185 ', '119 microm, 249 ', '11 eyes of 11 patients with macular oedema secondary to retinal vein occlusion', '276 microm preoperatively to 373 ', 'macular oedema secondary to retinal vein occlusion']","['pars plana vitrectomy with ILM peeling', 'Pars plana vitrectomy and internal limiting membrane peeling', 'pars plana vitrectomy and internal limited membrane (ILM) peeling', 'Pars plana vitrectomy and ILM peeling']","['mean thickness at the foveal centre', 'vitreous haemorrhage, recurrence of macular oedema and visual field defect', 'best-corrected visual acuity (BCVA), foveal thickness on optical coherence tomography, fundus fluorescein angiography (FFA) and multifocal electroretinography', 'macular oedema']","[{'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0035328', 'cui_str': 'Retinal Vein Occlusion'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0441602', 'cui_str': 'Peeling - action (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect (finding)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0430878', 'cui_str': 'Retinal angiography'}, {'cui': 'C1627756', 'cui_str': 'Multifocal electroretinography'}]",11.0,0.0565074,"At the final visit, BCVA improved 2 lines or more in 72.7% (8/11) of patients and was unchanged in 27.3% (3/11) patients.","[{'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China. Liangxlsums@yahoo.com.cn'}, {'ForeName': 'Hao-Yu', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Kah-Guan', 'Initials': 'KG', 'LastName': 'Au Eong', 'Affiliation': ''}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
923,32034943,Merging self-reported with technically sensed data for tracking mobility behavior in a naturalistic intervention study. Insights from the GISMO study.,"Sound exposure data are central for any intervention study. In the case of utilitarian mobility, where studies cannot be conducted in controlled environments, exposure data are commonly self-reported. For short-term intervention studies, wearable devices with location sensors are increasingly employed. We aimed to combine self-reported and technically sensed mobility data, in order to provide more accurate and reliable exposure data for GISMO, a long-term intervention study. Through spatio-temporal data matching procedures, we are able to determine the amount of mobility for all modes at the best possible accuracy level. Self-reported data deviate ±10% from the corrected reference. Derived modal split statistics prove high compliance to the respective recommendations for the control group (CG) and the two intervention groups (IG-PT, IG-C). About 73.7% of total mileage was travelled by car in CG. This share was 10.3% (IG-PT) and 9.7% (IG-C), respectively, in the intervention groups. Commuting distances were comparable in CG and IG, but annual mean travel times differ between  x   ¯     = 8,458 min (σ = 6,427 min) for IG-PT,  x   ¯     = 8,444 min (σ = 5,961 min) for IG-C, and  x   ¯     = 5,223 min (σ = 5,463 min) for CG. Seasonal variabilities of modal split statistics were observable. However, in IG-PT and IG-C no shift toward the car occurred during winter months. Although no perfect single-method solution for acquiring exposure data in mobility-related, naturalistic intervention studies exists, we achieved substantially improved results by combining two data sources, based on spatio-temporal matching procedures.",2020,"Derived modal split statistics prove high compliance to the respective recommendations for the control group (CG) and the two intervention groups (IG-PT, IG-C).",[],[],[],[],[],[],,0.0227001,"Derived modal split statistics prove high compliance to the respective recommendations for the control group (CG) and the two intervention groups (IG-PT, IG-C).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Loidl', 'Affiliation': 'Department of Geoinformatics, Paris Lodron University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Stutz', 'Affiliation': 'Department of Geoinformatics, Paris Lodron University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Fernandez Lapuente de Battre', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmied', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reich', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Bohm', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Sedlacek', 'Affiliation': 'HERRY Consult GmbH, Vienna, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zurich, Switzerland.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13636']
924,31508569,Effects of autologous platelet-rich plasma on endometrial expansion in patients undergoing frozen-thawed embryo transfer: A double-blind RCT.,"Background


Adequate endometrial growth is principal for implantation and pregnancy. Thin endometrium is associated with lower pregnancy rate in assisted reproductive technology. Some frozen-thawed embryo transfer cycles are cancelled due to inadequate endometrial growth.
Objective


To assess the effectiveness of autologous platelet-rich plasma (PRP) intrauterine infusion for the treatment of thin endometrium.
Materials and Methods


A total of 72 patients who had a history of cancelled frozen-thawed embryo transfer cycle due to the thin endometrium (  <  7mm) were assessed for the eligibility to enter the study between 2016 and 2017. Twelve patients were excluded for different reasons, and 60 included patients were randomly assigned to PRP or sham-catheter groups in a double-blind manner. Hormone replacement therapy was administered for endometrial preparation in all participants. PRP intrauterine infusion or shamcatheter was performed on day 11-12 due to the thin endometrium and it was repeated after 48 hr if necessary.
Results


Endometrial thickness increased at 48 hr after the first intervention in both groups. All participants needed second intervention due to an inadequate endometrial expansion. After second intervention, endometrial thickness was 7.21  ±  0.18 and 5.76  ±  0.97 mm in the PRP group and sham-catheter group, respectively. There was a significant difference between the two groups. (p  <  0.001). Embryo transfer was done for all patients in PRP group and just in six cases in the sham-catheter group. Chemical pregnancy was reported in twelve cases in the PRP group and two cases in the sham-catheter group.
Conclusion


According to this trial, PRP was effective in endometrial expansion in patients with refractory thin endometrium.",2019,"After second intervention, endometrial thickness was 7.21  ±  0.18 and 5.76  ±  0.97 mm in the PRP group and sham-catheter group, respectively.","['patients with refractory thin endometrium', 'patients undergoing frozen-thawed embryo transfer', 'Twelve patients were excluded for different reasons, and 60 included patients', '72 patients who had a history of cancelled frozen-thawed embryo transfer cycle due to the thin endometrium (  <  7mm) were assessed for the eligibility to enter the study between 2016 and 2017']","['PRP intrauterine infusion or shamcatheter', 'Hormone replacement therapy', 'PRP or sham-catheter', 'autologous platelet-rich plasma', 'PRP']","['Chemical pregnancy', 'endometrial thickness', 'Embryo transfer', 'Endometrial thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205544', 'cui_str': 'Canceled (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",72.0,0.144346,"After second intervention, endometrial thickness was 7.21  ±  0.18 and 5.76  ±  0.97 mm in the PRP group and sham-catheter group, respectively.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Nazari', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saghar', 'Initials': 'S', 'LastName': 'Salehpour', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Hoseini', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Zadehmodarres', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Eznoallah', 'Initials': 'E', 'LastName': 'Azargashb', 'Affiliation': 'Department of Health and Social Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i6.4816']
925,17095411,Does caffeine modify corticomotor excitability?,"AIMS


To test the influence of caffeine on the lower and upper motor neuron excitability.
METHODS


In Experiment A, 18 healthy subjects received 200 mg of caffeine or placebo, in a randomized, double-blind, placebo-controlled design protocol. Mean F-waves amplitude, amplitude of the motor response evoked by magnetic stimulation (MEP), MEP duration, cortical silent period (CSP), central conduction time, and cortical threshold were evaluated. In Experiment B, 6 healthy controls received 400 mg of caffeine, the peripheral silent period (PSP) and CSP were evaluated. CSP was recorded bilaterally in biceps brachii (intensity 10% above threshold) and abductor digiti minimi (ADM) (intensity at 10% and 50% above threshold). Muscle contraction was above 50% of the maximum force in both experiments. Latencies were defined by a technician who was not aware of this investigation. Serum caffeine level was evaluated.
RESULTS


In Experiment A, only the CSP, recorded in both ADM with intensity at 10% above threshold showed a significant change after caffeine (decrease of 17.1+/-34.0 ms, about 12% reduction). In Experiment B, PSP did not change, but CSP tested with intensities 10% above threshold was significantly decreased by 20.8+/-34.4 ms in ADM and 13.5+/-13.8 ms in biceps (about 13 and 16%, respectively). Serum caffeine level clearly increased after consumption but no correlation could be found between these levels and CSP reduction.
CONCLUSIONS


In our investigation, caffeine elicited a consistent decrease of the CSP, suggesting that caffeine increases cortical neuronal excitability.",2006,CSP was recorded bilaterally in biceps brachii (intensity 10% above threshold) and abductor digiti minimi (ADM) (intensity at 10% and 50% above threshold).,['18 healthy subjects'],"['caffeine', 'caffeine or placebo', 'placebo']","['Muscle contraction', 'cortical neuronal excitability', 'CSP', 'Mean F-waves amplitude, amplitude of the motor response evoked by magnetic stimulation (MEP), MEP duration, cortical silent period (CSP), central conduction time, and cortical threshold', 'Serum caffeine level', 'abductor digiti minimi (ADM) (intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026820', 'cui_str': 'Muscular Contraction'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1278114', 'cui_str': 'Serum caffeine measurement'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",18.0,0.143475,CSP was recorded bilaterally in biceps brachii (intensity 10% above threshold) and abductor digiti minimi (ADM) (intensity at 10% and 50% above threshold).,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cerqueira', 'Affiliation': 'Dementia Group, Institute of Molecular Medicine, Faculty of Medicine of Lisbon and Hospital de Santa Maria, Portugal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Mendonça', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Minez', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Dias', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Carvalho', 'Affiliation': ''}]",Neurophysiologie clinique = Clinical neurophysiology,[]
926,32127657,Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC).,"This study (NCT01288573) investigated plerixafor's safety and efficacy in children with cancer. Stage 1 investigated the dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor + standard mobilization (G-CSF ± chemotherapy). The stage 2 primary endpoint was successful mobilization (doubling of peripheral blood CD34+ cell count in the 24 h prior to first apheresis) in patients treated with plerixafor + standard mobilization vs. standard mobilization alone. In stage 1, three patients per age group (2-<6, 6-<12, and 12-<18 years) were treated at each dose level (160, 240, and 320 µg/kg). Based on PK and PD data, the dose proposed for stage 2 was 240 µg/kg (patients 1-<18 years), in which 45 patients were enrolled (30 plerixafor arm, 15 standard arm). Patient demographics and characteristics were well balanced across treatment arms. More patients in the plerixafor arm (24/30, 80%) met the primary endpoint of successful mobilization than in the standard arm (4/14, 28.6%, p = 0.0019). Adverse events reported as related to study treatment were mild, and no new safety concerns were identified. Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.",2020,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"['children with cancer', 'pediatric patients with solid tumors eligible for autologous transplants', 'pediatric cancer patients']","['Plerixafor combined with standard regimens', 'Plerixafor', 'plerixafor']","['successful mobilization', 'successful mobilization (doubling of peripheral blood CD34+ cell count', 'Adverse events', 'dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor\u2009+\u2009standard mobilization', 'tolerated and efficacious']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}]","[{'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",45.0,0.045626,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women's and Children's Hospital, Birmingham, UK. bruce.morland@nhs.net.""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kepak', 'Affiliation': 'University Hospital Brno and ICRC/St. Anna University Hospital, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Dallorso', 'Affiliation': 'IRCCS Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sevilla', 'Affiliation': 'Hospital Infantil Universitario Niño Jesus, FIB HIUNJ, CIBERER, Madrid, Spain.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': 'Royal Hospital for Children, Glasgow, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Luksch', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Yaniv', 'Affiliation': ""Schneider Children's Medical Center of Israel, Tel Aviv University, Petah Tikva, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': 'Universitätsklinikum Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Rößler', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Department for Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Maecker-Kolhoff', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': ""University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'C Michel', 'Initials': 'CM', 'LastName': 'Zwaan', 'Affiliation': ""Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sumerauer', 'Affiliation': 'Faculty Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'Kriván', 'Affiliation': 'United St Istvan and St Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bernard', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Doyle', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': ""IRCCS Bambino Gesù Children's Hospital, Rome, Italy.""}]",Bone marrow transplantation,['10.1038/s41409-020-0836-2']
927,32434296,[Application of Single-hole Thoracoscopic Surgery Combined with ERAS Concept for Respiratory Function Exercise in Perioperative Period of Lung Cancer].,"BACKGROUND


Lung cancer is currently the leading malignant tumor in both domestic and foreign morbidity and mortality. Surgical treatment is the main treatment option for lung cancer. The aim of this study is to explore the effects of enhanced recovery after surgery (ERAS) combined with respiratory function exercise combined with single-hole thoracoscopic surgery on lung cancer patients with postoperative pulmonary complications, postoperative pain, time to get out of bed, time to extubation and length of hospital stay.
METHODS


A total of 240 patients who underwent endoscopic lung cancer surgery at the Affiliated Hospital of Yangzhou University and the Yancheng First People's Hospital from October 2017 to October 2019 were randomly divided into 4 groups, with 60 patients in each group. Patients in group A underwent single-hole thoracoscopic surgery, and preoperatively performed ERAS concept education and respiratory function training; group B used conventional 3-hole thoracoscopic surgery, and performed ERAS concept education and respiratory function training before operation; group C used conventional 3-hole thoracoscopic operation surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS concept education; group D used single-hole thoracoscopic surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS concept mission. The number of postoperative pulmonary complications, postoperative pain, time to get out of bed, extubation time, and hospital stay were recorded in the four groups.
RESULTS


Compared with the groups B, C, and D, the incidence of pulmonary complications was significantly reduced, and the time to get out of bed, extubation time, and hospital stay were significantly shortened in group A. Compared with groups B, C, the postoperative pain was significantly reduced in group A. Compared with group C, the pulmonary complications were significantly reduced, and the time to get out of bed, extubation time and hospital stay were significantly shortened in group B. The differences were statistically significant (P<0.05). There was no significant difference in postoperative pain between group A and group D, group B and group C (P>0.05).
CONCLUSIONS


For patients with single-hole thoracoscopic lung cancer surgery, the ERAS concept guidance can effectively reduce the incidence of pulmonary complications and postoperative pain, shorten the time to get out of bed, the time to extubate, and the length of hospital stay.",2020,"There was no significant difference in postoperative pain between group A and group D, group B and group C (P>0.05).
","['lung cancer patients with postoperative pulmonary complications', 'patients with single-hole thoracoscopic lung cancer surgery', 'Perioperative Period of Lung Cancer', ""240 patients who underwent endoscopic lung cancer surgery at the Affiliated Hospital of Yangzhou University and the Yancheng First People's Hospital from October 2017 to October 2019""]","['single-hole thoracoscopic surgery, and preoperatively performed ERAS concept education and respiratory function training; group B used conventional 3-hole thoracoscopic surgery, and performed ERAS concept education and respiratory function training before operation; group C used conventional 3-hole thoracoscopic operation Surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS concept education; group D used single-hole thoracoscopic surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS Concept mission', 'Single-hole Thoracoscopic Surgery Combined with ERAS Concept for Respiratory Function Exercise', 'surgery (ERAS) combined with respiratory function exercise combined with single-hole thoracoscopic surgery']","['postoperative pain, time to get out of bed, time to extubation, and length of hospital stay', 'time to get out of bed, extubation time, and hospital stay', 'postoperative pain', 'time to get out of bed, extubation time and hospital stay', 'pulmonary complications', 'incidence of pulmonary complications', 'number of postoperative pulmonary complications, postoperative pain, time to get out of bed, extubation time, and hospital stay']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",240.0,0.0207493,"There was no significant difference in postoperative pain between group A and group D, group B and group C (P>0.05).
","[{'ForeName': 'Qingtong', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Thoracic Surgery, the Affiliated Hospital of Yangzhou University, Yangzhou 225000, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Diao', 'Affiliation': 'Department of Thoracic Surgery, the Affiliated Hospital of Yangzhou University, Yangzhou 225000, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Department of Thoracic Surgery, Yancheng First People's Hospital, Yancheng 224000, China.""}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2020.101.26']
928,31883336,Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder.,"INTRODUCTION


Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability.
AIMS AND METHODS


Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions-ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up.
RESULTS


We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms.
CONCLUSIONS


Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation.
IMPLICATIONS


In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.",2020,Usefulness of program skills was rated higher for WebQuit,"['Smokers With Bipolar Disorder', 'smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability', 'We screened 119 to enroll 51 participants (target sample size=60) over 24 months', 'smokers with bipolar disorder', 'Smokers with bipolar disorder (BD', 'Daily smokers (n=51) with bipolar I or II disorder']","['nicotine patch', 'ACT-based WebQuit Plus intervention, delivered in combination with nicotine patch', 'Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov', 'smoking cessation interventions-ACT-based WebQuit Plus (n=25) or Smokefree.gov']","['feasibility, intervention acceptability, and cessation at end-of-treatment and 1-month follow-up', 'acceptability and estimated effect size of WebQuit', 'abstinence rates', 'Retention', 'Mean number of logins']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",51.0,0.223883,Usefulness of program skills was rated higher for WebQuit,"[{'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelly', 'Affiliation': 'Edith Nourse Rogers Memorial VA Medical Center, Bedford, MA.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Waxmonsky', 'Affiliation': 'Department of Family Medicine, University of Colorado Anschutz Medical Center, Aurora, CO.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mattocks', 'Affiliation': 'VA Central Western Massachusetts Healthcare System, Leeds, MA.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Serfozo', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ostacher', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz242']
929,32124549,Do children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation? A report from the Children's Oncology Group.,"BACKGROUND


The role of adjuvant radiotherapy (RT) remains unclear in patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS).
PROCEDURE


Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed. All patients received systemic chemotherapy and 36 Gy adjuvant RT (if given) to the primary site at week 12 or week 4 for D9602/D9803 and ARST0531, respectively.
RESULTS


Thirty-six patients with group I ARMS were treated on D9602 (n = 6), D9803 (n = 17), or ARST0531 (n = 13), of whom 24 (67%) were male. The median age was 4.1 years (range, 0.8-45.8). Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors > 5 cm. FOXO1-fusion status was negative, positive, and unknown in 10 (28%), 15 (42%), and 11 (30%) tumors, respectively. Twenty-two (61%) patients received RT. Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively. Patients with FOXO1 positivity who received RT had superior EFS compared with those who did not (77.8% vs 16.7%; P = 0.03). Among 10 patients who were FOXO1 negative, the outcome was similar with or without RT.
CONCLUSIONS


Although limited by a small sample size, data from this study support the routine use of adjuvant RT in patients with FOXO1-positive disease even after complete resection. Additionally, omitting adjuvant RT is rational for patients with FOXO1-negative ARMS and will be prospectively investigated in the current COG trial ARST1431.",2020,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[""Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed"", 'children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation', 'patients with FOXO1-positive disease even after complete resection', 'The median age was 4.1 years (range, 0.8-45.8', 'patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS', 'Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors\xa0>\xa05\xa0cm', 'Thirty-six patients with group', '10 patients who were FOXO1 negative, the outcome was similar with or without\xa0RT']","['adjuvant radiotherapy (RT', 'systemic chemotherapy and 36\xa0Gy adjuvant RT', 'RT']","['free survival (EFS) and overall survival (OS', 'superior EFS', 'FOXO1-fusion status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",36.0,0.138132,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Aye', 'Affiliation': ""Department of Pediatrics, Children's of Alabama, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Rudzinski', 'Affiliation': ""Department of Pathology, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Odion T', 'Initials': 'OT', 'LastName': 'Binitie', 'Affiliation': ""Department of Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Pediatric General and Thoracic Surgery, Cincinnati Children's Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Wolden', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Abha A', 'Initials': 'AA', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada.'}]",Pediatric blood & cancer,['10.1002/pbc.28243']
930,17051276,Leadership and professionalism curriculum in the Gross Anatomy course.,"INTRODUCTION


Today's physicians must demonstrate both professionalism and leadership skills in order to succeed in largely team-based healthcare environments. The purpose of this study was to determine if professionalism attributes, leadership style, and leadership style adaptability are associated with academic performance among first-year students early in their medical curriculum.
MATERIALS AND METHODS


Students were divided into 4-member dissection groups for the duration of the Gross and Developmental Anatomy course. Leadership responsibility was randomly assigned to a team member on a rotating basis every 5 weeks. After each 5-week block, student performance was measured by written and practical examinations, and each student assessed their leader's or their own professionalism attributes and leadership style using validated survey instruments.
RESULTS


Most students demonstrated either a ""selling"" only (57%) or ""participating"" only (30%) leadership style with low to moderate leadership adaptability. ""Participating"" and ""delegating"" leadership styles have the highest average group written exam scores (89.4%, P <0.008). ""Telling"" only or ""selling"" only leaders have the lowest average group exam scores (83.5%, P <0.001). ""Selling"" and ""participating"" leaders have significantly lower average group practical exam scores than other styles (81.5%, P <0.007). Positive associations were observed between the written and practical examination scores and the leader's integrity (P = 0.003, P = 0.002) and responsibility (P <0.001, P = 0.037).
CONCLUSIONS


This study demonstrates that various situational leadership styles and aspects of professionalism are associated with written and practical examination scores in the Gross and Developmental Anatomy course. Furthermore, it demonstrates that first-year medical students are in need of leadership skill development.",2006,"Positive associations were observed between the written and practical examination scores and the leader's integrity (P = 0.003, P = 0.002) and responsibility (P <0.001, P = 0.037).
","['first-year students early in their medical curriculum', 'Students were divided into 4-member dissection groups for the duration of the Gross and Developmental Anatomy course']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",[],[],,0.017364,"Positive associations were observed between the written and practical examination scores and the leader's integrity (P = 0.003, P = 0.002) and responsibility (P <0.001, P = 0.037).
","[{'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Pawlina', 'Affiliation': 'Department of Anatomy, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. pawlina.wojciech@mayo.edu'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hromanik', 'Affiliation': ''}, {'ForeName': 'Tia R', 'Initials': 'TR', 'LastName': 'Milanese', 'Affiliation': ''}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Dierkhising', 'Affiliation': ''}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Viggiano', 'Affiliation': ''}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Carmichael', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
931,17051278,The impact of experiential learning on NUS medical students: our experience with task trainers and human-patient simulation.,"INTRODUCTION


Experiential learning is one of the key methods for effective teaching of medical students. The use of simulation is ideal to achieve this goal. Simulation training allows the learner to be actively involved, and provides realism, self-direction, feedback and practice. We present 2 pilot projects in which the efficacy of experiential learning with simulation is demonstrated.
MATERIALS AND METHODS


In the first project, groups of 4 to 6 fourth-year medical students were exposed to common crisis scenarios. Each student took turns to individually handle the situation (in the hot seat), while the rest of the group watched ""live"" via video-link. A group debrief was done after the completion of all scenarios and learning points were emphasized. A test was conducted shortly after, and the student who managed the same scenario in the hot seat earlier was compared to the rest of the group with respect to crisis recognition, management and diagnosis. In the second project, 36 fourth-year medical students were assigned to learn endotracheal intubation through a directed or experiential method. Students were recalled after 3 months and tested on 4 major categories: preparation, technique, success and ventilation.
RESULTS


Students in the hot seat tended to perform better (72% vs. 64%), and were more likely to be the highest scoring student within their group; although this did not reach statistical significance. For the intubation study, students in the experiential group had a higher success rate at 3 months (78% vs. 41%).
CONCLUSIONS


Experiential teaching methods with simulation result in better learning of crisis management and endotracheal intubation.",2006,"RESULTS


Students in the hot seat tended to perform better (72% vs. 64%), and were more likely to be the highest scoring student within their group; although this did not reach statistical significance.","['36 fourth-year medical students', 'NUS medical students']","['experiential learning', 'learn endotracheal intubation through a directed or experiential method', 'Simulation training']",['success rate'],"[{'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0243012', 'cui_str': 'Experiential Learning'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]",[],,0.0293817,"RESULTS


Students in the hot seat tended to perform better (72% vs. 64%), and were more likely to be the highest scoring student within their group; although this did not reach statistical significance.","[{'ForeName': 'Lian-Kah', 'Initials': 'LK', 'LastName': 'Ti', 'Affiliation': 'Department of Anaesthesia, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Gee-Mei', 'Initials': 'GM', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Sabrina Gwendolyn M Y', 'Initials': 'SG', 'LastName': 'Khoo', 'Affiliation': ''}, {'ForeName': 'Fun-Gee', 'Initials': 'FG', 'LastName': 'Chen', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
932,31508577,Sublingual Misoprostol versus Foley catheter for cervical ripening in women with preeclampsia or gestational hypertension: A randomized control trial.,"Background


Delivery is the only definite cure for hypertensive disorders. Therefore, cervical ripening and labor induction are important to achieve favorable outcomes.
Objective


This Randomized Control Trial (RCT) is aimed to compare the effects of sublingual misoprostol and Foley catheter in cervical ripening and labor induction among patients with preeclampsia or gestational hypertension.
Materials and Methods


A total number of 144 women with preeclampsia or gestational hypertention with indication of pregnancy termination, who were referred to academic hospitals of the University of Medical Sciences in Mashhad, Iran, between March 2015 and December 2016, were randomly divided into two groups. In group one (n = 72), 25 µg of misoprostol tablet was administrated sublingually every 4 hr up to six doses. In group two (n = 72), a 16F Foley catheter was placed through the internal cervical os, inflated with 60 cc of sterile saline.
Results


There were no significant differences between groups regarding the demographic characteristics, primary bishop score, and pregnancy termination indication. The cervical ripening time (primary outcome) (8.2 vs 14.2 hr, p  <  0.00), induction to delivery interval (15.5 vs 19.9 hr, p  <  0.00), and vaginal delivery before 24 hr (63.9% vs 40%, p = 0.03) were significantly different between the two groups. There was no significant difference between groups in view of oxytocin requirement (p = 0.12), neonatal Apgar score (p = 0.84), or neonatal intensive care unit admission (p = 78).
Conclusion


This trial showed that the application of sublingual misoprostol, compared to the Foley catheter, can reduce cervical ripening period and other parameters related to the duration of vaginal delivery. This misoprostol regimen showed inconsiderable maternal complications.",2019,"There was no significant difference between groups in view of oxytocin requirement (p = 0.12), neonatal Apgar score (p = 0.84), or neonatal intensive care unit admission (p = 78).
","['women with preeclampsia or gestational hypertension', 'patients with preeclampsia or gestational hypertension', '144 women with preeclampsia or gestational hypertention with indication of pregnancy termination, who were referred to academic hospitals of the University of Medical Sciences in Mashhad, Iran, between March 2015 and December 2016']","['sublingual misoprostol and Foley catheter', 'Sublingual Misoprostol', 'sublingual misoprostol', 'misoprostol', 'Foley catheter', '16F Foley catheter was placed through the internal cervical os, inflated with 60 cc of sterile saline', 'misoprostol tablet']","['cervical ripening time', 'inconsiderable maternal complications', 'induction to delivery interval', 'neonatal intensive care unit admission', 'view of oxytocin requirement', 'vaginal delivery', 'neonatal Apgar score', 'demographic characteristics, primary bishop score, and pregnancy termination indication']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0179804'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C1185785', 'cui_str': 'External os structure'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}]",144.0,0.134321,"There was no significant difference between groups in view of oxytocin requirement (p = 0.12), neonatal Apgar score (p = 0.84), or neonatal intensive care unit admission (p = 78).
","[{'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Ayati', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Hasanzadeh', 'Affiliation': 'Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Pourali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammadtaghi', 'Initials': 'M', 'LastName': 'Shakeri', 'Affiliation': 'Department of Epidemiology and Biostatics, Health School, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Atiye', 'Initials': 'A', 'LastName': 'Vatanchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i7.4863']
933,31707770,Individuals With Recurrent Low Back Pain Exhibit Significant Changes in Paraspinal Muscle Strength After Intramuscular Fine Wire Electrode Insertion.,"OBJECTIVE


To examine how insertion and presence of intramuscular fine-wire electromyography electrodes (IFWEs) in lumbar multifidus affect paraspinal muscle strength, endurance, and activation in persons with and without recurrent lower back pain (RLBP) during activities that require high levels of muscle contraction.
DESIGN


Case-control with randomization of conditions.
SETTING


Clinical research laboratory.
PARTICIPANTS


Forty participants age 18 to 40 years were recruited (18 female; mean age = 25.5 years); 20 with a history of RLBP were compared to a matching control group of 20 without RLBP.
INTERVENTIONS


Each participant was tested under three conditions over three sessions. On Session 1, the baseline condition, we assessed muscle performance without IFWE insertion. On Sessions 2 and 3, participants were randomly alternated between two experimental conditions: (1) wire-in, in which the IFWE was inserted and remained within the muscle during testing; and (2) wire-out, in which the IFWE was inserted and immediately removed.
MAIN OUTCOME MEASUREMENTS


Lumbar spinal extensor peak strength, endurance, and normalized electromyography (EMG) amplitude during the endurance test.
RESULTS


Individuals with RLBP showed a significant decrease in peak strength during conditions that involved IFWE insertion and tend to experience more pain during muscle testing. Both groups exhibited similar levels of performance and muscle activation during the endurance test.
CONCLUSION


Our findings indicate that individuals with RLBP exhibited reduced lumbar extensor strength in response to IFWE insertion to the deep paraspinal muscles. This behavior is different from those without RLBP. Researchers should carefully consider the use of IFWE in individuals with RLBP during high exertion activities.",2020,"Both groups exhibited similar levels of performance and muscle activation during the endurance test.
","['persons with and without recurrent lower back pain (RLBP', 'individuals with RLBP during high exertion activities', 'Forty participants age 18-40 were recruited (18 female; mean age\u2009=\u200925.5\u2009yr); 20 with a history of RLBP']","['intramuscular fine-wire electromyography electrodes (IFWE', 'matching control group of 20 without RLBP']","['Paraspinal Muscle Strength', 'performance and muscle activation', 'peak strength', 'Lumbar spinal extensor peak strength, endurance, and normalized EMG amplitude during the endurance test', 'lumbar extensor strength']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0448353', 'cui_str': 'Deep Muscles of the Back'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",40.0,0.0413105,"Both groups exhibited similar levels of performance and muscle activation during the endurance test.
","[{'ForeName': 'Szu-Ping', 'Initials': 'SP', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dinglasan', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Totten', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Jo A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Physical Therapy, Chapman University, Orange, CA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12284']
934,31985516,Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial.,"PURPOSE


NRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data.
METHODS


Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm-6 cycles of gemcitabine. Gemcitabine+erlotinib arm-gemcitabine and erlotinib 100 mg/d. Two hundred deaths provided 90% power (1-sided α=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2.
RESULTS


From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ≤90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38).
CONCLUSIONS


The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.",2020,"GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22).","['Resected Cancer of the Pancreatic Head', 'From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2', 'Median age was 63 (39 to 86) years', 'patients with resected pancreatic head adenocarcinoma', 'Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180']","['Gemcitabine', 'fluoropyrimidine', 'gemcitabine and erlotinib', 'Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine', 'gemcitabine-based adjuvant chemotherapy', 'gemcitabine', 'Gemcitabine+erlotinib arm-gemcitabine and erlotinib']","['median and 3-year OS', 'survival', 'Hazard ratio', 'hypothesized OS signal']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",163.0,0.114886,"GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22).","[{'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Abrams', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Winter', 'Affiliation': 'NRG Oncology Statistics and Data Management Center.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Safran', 'Affiliation': 'Rhode Island Hospital.'}, {'ForeName': 'Karyn A', 'Initials': 'KA', 'LastName': 'Goodman', 'Affiliation': 'University of Colorado Cancer Center, Denver, CO.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Regine', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, MD.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Berger', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Gillin', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Wayne State University/Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Lowy', 'Affiliation': 'UC San Diego Moores Cancer Center, San Diego.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'DiPetrillo', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Corn', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Seaward', 'Affiliation': 'Department of Radiation Oncology.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Haddock', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Suisui', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'USC/Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, MD.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Fisher', 'Affiliation': 'London Regional Cancer Program, London, ON, Canada.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Katz', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Spartanburg Regional Medical Center, Spartanburg, SC.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Willett', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Crane', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York.'}]",American journal of clinical oncology,['10.1097/COC.0000000000000633']
935,31952323,Does Hydrotherapy Impact Behaviours Related to Mental Health and Well-Being for Children with Autism Spectrum Disorder? A Randomised Crossover-Controlled Pilot Trial.,"BACKGROUND


Children diagnosed with Autism Spectrum Disorder (ASD) are less physically active than typically developing children due to reduced socialisation and delayed gross-motor skills, negatively impacting social, emotional and physical well-being. This study aimed to determine whether hydrotherapy influences behaviours which impact mental health and well-being in children with ASD.
METHODS


A within-subjects, randomised crossover-controlled pilot trial was used over 8 weeks. Children aged 6-12 years and diagnosed with ASD (n = 8) were randomly allocated to Group 1 (n = 4) or Group 2 (n = 4). All children participated in hydrotherapy intervention from either weeks 1 to 4 or weeks 5 to 8. The Child Behaviour Checklist (CBCL) measured behaviour changes impacting mental health and well-being, administered at weeks 0, 4 and 8.
RESULTS


No observable differences were found in CBCL subscales between Group 1 or 2 at baseline (week 0). Paired-samples t-tests revealed significant improvements post-intervention: Anxious/Depressed subdomain (p = 0.02) and the Internalising Problems Domain Summary (p = 0.026), with large effect size (d = 1.03 and d = 1.06 respectively). Thought Problems (p = 0.03) and Attention Problems (p = 0.01) both significantly improved post-intervention. The Total Problems score significantly improved post-intervention (p = 0.018) with a large effect size (d = 1.04).
CONCLUSION


Hydrotherapy may enhance behaviours impacting mental health and well-being of children with ASD and could be considered a beneficial therapy option.",2020,"The Total Problems score significantly improved post-intervention (p = 0.018) with a large effect size (d = 1.04).
","['Children aged 6-12 years and diagnosed with ASD (n = 8', 'children with ASD', 'Children diagnosed with Autism Spectrum Disorder (ASD', 'Children with Autism']","['Hydrotherapy', 'hydrotherapy intervention', 'hydrotherapy']","['Total Problems score', 'Attention Problems', 'Child Behaviour Checklist (CBCL) measured behaviour changes impacting mental health', 'Anxious/Depressed subdomain', 'CBCL subscales']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.264366,"The Total Problems score significantly improved post-intervention (p = 0.018) with a large effect size (d = 1.04).
","[{'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Mills', 'Affiliation': 'Physiotherapy Department; Bond University Faculty of Health Sciences and Medicine, 2 Promethean Way, Robina, QLD 4226, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kondakis', 'Affiliation': 'Physiotherapy Department; Bond University Faculty of Health Sciences and Medicine, 2 Promethean Way, Robina, QLD 4226, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Orr', 'Affiliation': 'Physiotherapy Department; Bond University Faculty of Health Sciences and Medicine, 2 Promethean Way, Robina, QLD 4226, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Warburton', 'Affiliation': 'Physiotherapy Department; Gateway Physiotherapy, 17/590 Mount Gravatt Capalaba Road, Wishart, QLD 4122, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Milne', 'Affiliation': 'Physiotherapy Department; Bond University Faculty of Health Sciences and Medicine, 2 Promethean Way, Robina, QLD 4226, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17020558']
936,15608836,Spironolactone does not prevent restenosis after coronary stenting in humans.,"INTRODUCTION


In animal studies, aldosterone enhanced neointimal proliferation by increasing extracellular accumulation of collagen and potentiating the effects of angiotensin II. Spironolactone, an aldosterone antagonist, is a potent inhibitor of neointimal proliferation. We conducted a placebo-controlled, double-blind, randomised study to assess the effect of spironolactone on angiographic 6-month in-stent restenosis.
MATERIALS AND METHODS


Of the 310 randomised patients with significant coronary artery disease, 258 patients were available for analysis: 128 constituted the placebo group and 130 were assigned to receive spironolactone. Eligible patients were randomly assigned to receive a dose of 50 mg spironolactone or placebo orally twice a day for 6 months. The primary endpoint was the angiographic restenosis (>50% stenosis) rate at follow-up angiography.
RESULTS


At 6-month follow-up angiography after stenting, there was no difference between the 2 groups in minimal lumen diameter, percent diameter stenosis, late loss, and net gain. Angiographic restenosis occurred in 46 (35.4%) of 130 patients receiving spironolactone and 50 (39.0%) of 128 in the placebo group with an odds ratio (OR) of 0.85 with a 95% confidence interval (CI) of 0.49 to 1.46 (P = 0.62). Restenosis rate was found in 60 (32.9%) of 182 lesions in the spironolactone group, and 61 (35.5%) of 172 lesions in the placebo group with an OR of 0.89 with a 95% CI of 0.56 to 1.42 (P = 0.89).
CONCLUSIONS


Spironolactone did not reduce the incidence of in-stent restenosis as compared with placebo in human, contrary to the fact that reduction of neointimal formation in animal models has been observed upon administration of spironolactone.",2004,"At 6-month follow-up angiography after stenting, there was no difference between the 2 groups in minimal lumen diameter, percent diameter stenosis, late loss, and net gain.","['Of the 310 randomised patients with significant coronary artery disease', 'Eligible patients', 'after coronary stenting in humans', '258 patients were available for analysis: 128 constituted the placebo group and 130 were assigned to receive']","['placebo', 'aldosterone', 'Spironolactone', 'spironolactone', 'spironolactone or placebo']","['Restenosis rate', 'minimal lumen diameter, percent diameter stenosis, late loss, and net gain', 'incidence of in-stent restenosis', 'angiographic restenosis', 'restenosis', 'Angiographic restenosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}]",258.0,0.430639,"At 6-month follow-up angiography after stenting, there was no difference between the 2 groups in minimal lumen diameter, percent diameter stenosis, late loss, and net gain.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kursaklioglu', 'Affiliation': 'Cardiac Catheterization Laboratory, Department of Cardiology, Gulhane Military Medical Academy, Turkey. shurkan@superonline.com'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Iyisoy', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Amasyali', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Celik', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ozturk', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kose', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Isik', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
937,32011721,Text2Connect: a health system approach to engage tobacco users in quitline cessation services via text messaging.,"Mobile technology has created the opportunity for health systems to provide low cost tobacco cessation assistance to patients. The goal of the present study was to examine the feasibility and effectiveness of an intervention (Text2Connect) that uses text messages to offer proactive connection to the New York State Smokers' Quitline. The electronic health record at two urban health systems was queried for patients who were current smokers and who had an outpatient visit between March 2015 and February 2016. Smokers (N = 4000) were sent an informational letter. Those who did not opt out (N = 3719) were randomized to one of 6 message sequences in order to examine the effect of theoretically informed message frames on response rates. Participants were sent a series of text messages at baseline and at 1 month and were asked to reply in order to be contacted by the state quitline (QL). After removing 1403 nonworking numbers, texts were sent to 2316 patients, and 10.0% (205/2060) responded with a QL request. Almost one quarter (23.6%, 486/2060) replied STOP and 66.4% (1369/2060) never responded. QL request rates were significantly higher when response efficacy messages were not used (p < .001). There were no differences by message framing on STOP requests (p > .05). The Text2Connect intervention was well accepted with a minority opting out. A 10% QL response rate is noteworthy given that only 5-7 brief outreach text messages were used. Results indicate that simple self-efficacy-focused messaging is most effective at supporting response rates.",2020,QL request rates were significantly higher when response efficacy messages were not used (p < .001).,"['Smokers (N = 4000', 'Those who did not opt out (N = 3719', 'patients who were current smokers and who had an outpatient visit between March 2015 and February 2016', 'engage tobacco users in quitline cessation services via text messaging']","['intervention (Text2Connect', 'Text2Connect intervention', 'Text2Connect']","['QL request rates', 'STOP requests', 'QL response rate']","[{'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241966'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]",[],"[{'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]",4000.0,0.042195,QL request rates were significantly higher when response efficacy messages were not used (p < .001).,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Krebs', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wilson', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El-Shahawy', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Lorien L', 'Initials': 'LL', 'LastName': 'Abroms', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Xiaoquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Nahvi', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz033']
938,15098638,Impact of a pharmacist consult clinic on a hospital-based geriatric outpatient clinic in Singapore.,"INTRODUCTION


We study the impact of a pharmacist consult clinic on the care of elderly outpatients based on the Health Belief Model that the perceived benefits (improvement in medication knowledge, clinical status and perception) and attached barriers (cost and number of medication and adverse drug reactions) can influence health behaviour (medication compliance).
MATERIALS AND METHODS


A randomised controlled study of 136 eligible patients with risk factors for non-compliance, using Zelen's design, was conducted in a hospital-based geriatric outpatient clinic from November 2001 to June 2002. All patients were assessed for outcome variables at baseline and 2 months later.
RESULTS


One hundred and twenty-six patients were included in the intention-to-treat analysis. There were 104 pharmacist interventions with a physician acceptance rate of 76%. There was a significant improvement in medication knowledge with regards to indication (P = 0.03) and the composite dose, frequency and indication score (P = 0.06), as well as a decrease in residual adverse drug reactions that persisted at month 2 and cost avoidance of dollars 387.28 over 2 months. There was no significant difference in perception, clinical status or decrease in number of medications. The intervention group showed an improvement in adjusted compliance (odds ration [OR] = 2.52; 90% confidence interval [CI], 1.09 to 5.83) based on the ordered logistic regression model. Perception of severity of illness at baseline (OR = 1.30; 90% CI, 1.04 to 1.62), number of medication remembering methods (OR = 1.87; 90% CI, 1.08 to 3.25) and the use of routine habits (OR = 4.48; 90% CI, 1.51 to 13.28) and medication aids (OR = 3.68; 90% CI, 1.04 to 13.06) significantly affected compliance.
CONCLUSION


The addition of a pharmacist consult clinic to the management of selected geriatric outpatients can improve compliance, with the attendant benefits of improving medication knowledge, cost avoidance and reducing residual adverse drug reactions.",2004,"There was a significant improvement in medication knowledge with regards to indication (P = 0.03) and the composite dose, frequency and indication score (P = 0.06), as well as a decrease in residual adverse drug reactions that persisted at month 2 and cost avoidance of dollars 387.28 over 2 months.","['on a hospital-based geriatric outpatient clinic in Singapore', 'selected geriatric outpatients', 'elderly outpatients', ""136 eligible patients with risk factors for non-compliance, using Zelen's design, was conducted in a hospital-based geriatric outpatient clinic from November 2001 to June 2002"", 'One hundred and twenty-six patients were included in the intention-to-treat analysis']",['pharmacist consult clinic'],"['number of medication remembering methods', 'Perception of severity of illness', 'medication knowledge', 'residual adverse drug reactions', 'routine habits', 'composite dose, frequency and indication score', 'perception, clinical status or decrease in number of medications', 'adjusted compliance']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",136.0,0.03054,"There was a significant improvement in medication knowledge with regards to indication (P = 0.03) and the composite dose, frequency and indication score (P = 0.06), as well as a decrease in residual adverse drug reactions that persisted at month 2 and cost avoidance of dollars 387.28 over 2 months.","[{'ForeName': 'W S', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Department of Geriatric Medicine, Tan Tock Seng Hospital, Singapore. Wee_Shiong_Lim@ttsh.com.sg'}, {'ForeName': 'H N', 'Initials': 'HN', 'LastName': 'Low', 'Affiliation': ''}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'H N', 'Initials': 'HN', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Tan', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
939,31504798,"Smoking Cessation in the ITALUNG Lung Cancer Screening: What Does ""Teachable Moment"" Mean?","BACKGROUND


Changes in smoking habits and predictors of smoking cessation were examined in the randomized ITALUNG lung cancer screening trial.
METHODS


In three centers, eligible smokers or ex-smokers (55-69 years, ≥20 pack-years in the last 10 years) were randomized to receive annual invitation for low-dose computed tomography for 4 years or usual care. At invitation, subjects received written information for a free smoking cessation program. Quitting outcome was assessed at year 4.
RESULTS


Among participants who completed baseline assessments and year 4 screening, higher quitting (20.8% vs. 16.7%, p = .029) and lower relapse (6.41% vs. 7.56%, p = .50) rates were observed in the active screening group as compared to the usual-care control group. Corresponding figures in the intention-to-treat analysis were as follows: 16.04% versus 14.64% (p = .059) and 4.88% versus 6.43% (p = .26). Quitting smoking was significantly associated to male gender, lower pack-years, and having pulmonary nodules at baseline. Center-specific analyses showed a threefold statistically significant higher probability to quit associated with participating in the smoking cessation program. A subsample of smokers of the scan group from one center showed higher quitting rates over 12-month follow-up as compared to matched controls from the general population who underwent the same smoking cessation program.
CONCLUSIONS


Consistently with previous reports, in the ITALUNG trial, screened subjects showed significantly higher quit rates than controls, and higher quit rates were associated with both the presence of pulmonary nodules and participating in a smoking cessation program. Maximal effect on quitting outcome was observed with the participation in the smoking cessation program.
IMPLICATIONS


Participating in lung cancer screening promotes smoking cessation. An effective ""teachable moment"" may be achieved when the smoking cessation intervention is structured as integral part of the screening clinical visits and conducted by a dedicated team of health care professionals. Standardized guidelines for smoking cessation interventions in lung cancer screening are needed.",2020,Center-specific analyses showed a three-fold statistically significant higher probability to quit associated with participating in the smoking cessation program.,"['eligible smokers or ex-smokers (55-69 years, ≥ 20 pack-years in the last 10 years', 'Participating in lung cancer screening promotes smoking cessation', 'lung cancer screening']",['annual invitation for low-dose computed tomography for 4 years or usual care'],"['Quitting outcome', 'quit rates', 'quitting rates', 'Smoking cessation', 'Quitting smoking', 'quitting outcome', 'lower relapse']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0174261,Center-specific analyses showed a three-fold statistically significant higher probability to quit associated with participating in the smoking cessation program.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pistelli', 'Affiliation': 'Pulmonary Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Ferruccio', 'Initials': 'F', 'LastName': 'Aquilini', 'Affiliation': 'Pulmonary Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falaschi', 'Affiliation': '2nd Radiodiagnostic Unit, Department of Diagnostic Imaging, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ocello', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lopes Pegna', 'Affiliation': 'Formerly Pneumonology Department, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Francesca Maria', 'Initials': 'FM', 'LastName': 'Carozzi', 'Affiliation': 'Cancer Prevention Regional Laboratory, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Picozzi', 'Affiliation': 'Clinical Breast Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy, Florence, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mascalchi', 'Affiliation': 'Formerly Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Paci', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carrozzi', 'Affiliation': 'Pulmonary Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz148']
940,15114532,Extended linkage disequilibrium surrounding the hemoglobin E variant due to malarial selection.,"The hemoglobin E variant (HbE; ( beta )26Glu-->Lys) is concentrated in parts of Southeast Asia where malaria is endemic, and HbE carrier status has been shown to confer some protection against Plasmodium falciparum malaria. To examine the effect of natural selection on the pattern of linkage disequilibrium (LD) and to infer the evolutionary history of the HbE variant, we analyzed biallelic markers surrounding the HbE variant in a Thai population. Pairwise LD analysis of HbE and 43 surrounding biallelic markers revealed LD of HbE extending beyond 100 kb, whereas no LD was observed between non-HbE variants and the same markers. The inferred haplotype network suggests a single origin of the HbE variant in the Thai population. Forward-in-time computer simulations under a variety of selection models indicate that the HbE variant arose 1,240-4,440 years ago. These results support the conjecture that the HbE mutation occurred recently, and the allele frequency has increased rapidly. Our study provides another clear demonstration that a high-resolution LD map across the human genome can detect recent variants that have been subjected to positive selection.",2004,"Pairwise LD analysis of HbE and 43 surrounding biallelic markers revealed LD of HbE extending beyond 100 kb, whereas no LD was observed between non-HbE variants and the same markers.",[],[],['hemoglobin E variant (HbE; ( beta )26Glu-->Lys'],[],[],"[{'cui': 'C0019024', 'cui_str': 'Hemoglobin E'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0067291', 'cui_str': ""N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid""}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",,0.024525,"Pairwise LD analysis of HbE and 43 surrounding biallelic markers revealed LD of HbE extending beyond 100 kb, whereas no LD was observed between non-HbE variants and the same markers.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ohashi', 'Affiliation': 'Department of Human Genetics, The University of Tokyo, Tokyo, Japan. juno-tky@umin.ac.jp'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Naka', 'Affiliation': ''}, {'ForeName': 'Jintana', 'Initials': 'J', 'LastName': 'Patarapotikul', 'Affiliation': ''}, {'ForeName': 'Hathairad', 'Initials': 'H', 'LastName': 'Hananantachai', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Brittenham', 'Affiliation': ''}, {'ForeName': 'Sornchai', 'Initials': 'S', 'LastName': 'Looareesuwan', 'Affiliation': ''}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Katsushi', 'Initials': 'K', 'LastName': 'Tokunaga', 'Affiliation': ''}]",American journal of human genetics,[]
941,15154115,Long-term safety and efficacy of enzyme replacement therapy for Fabry disease.,"Elsewhere, we reported the safety and efficacy results of a multicenter phase 3 trial of recombinant human alpha -galactosidase A (rh-alpha GalA) replacement in patients with Fabry disease. All 58 patients who were enrolled in the 20-wk phase 3 double-blind, randomized, and placebo-controlled study received subsequently 1 mg/kg of rh-alpha GalA (agalsidase beta, Fabrazyme, Genzyme Corporation) biweekly in an ongoing open-label extension study. Evidence of long-term efficacy, even in patients who developed IgG antibodies against rh- alpha GalA, included the continuously normal mean plasma globotriaosylceramide (GL-3) levels during 30 mo of the extension study and the sustained capillary endothelial GL-3 clearance in 98% (39/40) of patients who had a skin biopsy taken after treatment for 30 mo (original placebo group) or 36 mo (original enzyme-treated group). The mean serum creatinine level and estimated glomerular filtration rate also remained stable after 30-36 mo of treatment. Infusion-associated reactions decreased over time, as did anti-rh- alpha GalA IgG antibody titers. Among seroconverted patients, after 30-36 mo of treatment, seven patients tolerized (no detectable IgG antibody), and 59% had > or =4-fold reductions in antibody titers. As of 30 mo into the extension trial, three patients were withdrawn from the study because of positive serum IgE or skin tests; however, all have been rechallenged successfully at the time of this report. Thus, enzyme replacement therapy for 30-36 mo with agalsidase beta resulted in continuously decreased plasma GL-3 levels, sustained endothelial GL-3 clearance, stable kidney function, and a favorable safety profile.",2004,"Infusion-associated reactions decreased over time, as did anti-rh- alpha GalA IgG antibody titers.","['All 58 patients who were enrolled in the 20-wk phase 3 double-blind, randomized, and', 'Fabry disease', 'patients who developed IgG antibodies against rh', 'patients with Fabry disease']","['subsequently 1 mg/kg of rh-alpha GalA (agalsidase beta, Fabrazyme, Genzyme Corporation', 'enzyme replacement therapy', 'recombinant human alpha -galactosidase', 'placebo']","['plasma GL-3 levels, sustained endothelial GL-3 clearance, stable kidney function, and a favorable safety profile', 'mean serum creatinine level and estimated glomerular filtration rate', 'continuously normal mean plasma globotriaosylceramide (GL-3) levels', 'antibody titers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0002986', 'cui_str': 'alpha-Galactosidase A Deficiency'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1137427', 'cui_str': 'agalsidase beta'}, {'cui': 'C1137428', 'cui_str': 'Fabrazyme'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0002268', 'cui_str': 'ALPHA-D-GALACTOSIDASE ENZYME'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C3811844'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0061338', 'cui_str': 'P(K) antigen'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",3.0,0.151544,"Infusion-associated reactions decreased over time, as did anti-rh- alpha GalA IgG antibody titers.","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Wilcox', 'Affiliation': 'Cedars-Sinai Burns and Allen Research Institute and UCLA School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Banikazemi', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Guffon', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Waldek', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Gabor E', 'Initials': 'GE', 'LastName': 'Linthorst', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Desnick', 'Affiliation': ''}, {'ForeName': 'Dominique P', 'Initials': 'DP', 'LastName': 'Germain', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of human genetics,[]
942,31504974,"Brief, one-on-one, telephone-adapted mindfulness-based stress reduction for patients undergoing percutaneous coronary intervention: a randomized controlled trial.","Psychological distress and negative conditions are highly frequent in patients with percutaneous coronary intervention (PCI). Mindfulness-based stress reduction (MBSR) has been shown to be effective in reducing psychological symptoms in patients with chronic diseases. The available evidence has supported the potential benefit of MBSR for PCI patients. However, the traditional group classroom format and long exercise times of MBSR were deemed as barriers to access for these patients. The aim of this study was to examine the short-term effectiveness of a brief, one-on-one, telephone-adapted MBSR on psychological distress of PCI patients. A randomized controlled trial was conducted. Seventy consecutive PCI patients who met the inclusion criteria were randomized to a three-session mindfulness intervention group (N = 35) or a waitlist control group (N = 35). The Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), and short form of the Freiburg Mindfulness Inventory (FMI-s) were used to assess anxiety and depression, stress, and mindfulness before and after the intervention. Sixty-two patients completed the study. Compared with the waitlist group, the MBSR group showed greater decreases in HADS (p = .006) and PSS (p = .035) scores. The intention-to-treat (ITT) analysis also demonstrated that HADS (p = .018) and PSS (p = .037) scores decreased significantly in the MBSR group compared with those in the waitlist group at Week 6. These effects were mediated by an increase in mindfulness. The brief, one-on-one, telephone-adapted mindfulness intervention can improve psychological symptoms in PCI patients.",2019,"Compared with the waitlist group, the MBSR group showed greater decreases in HADS (p = .006) and PSS (p = .035) scores.","['PCI patients', 'patients undergoing percutaneous coronary intervention', 'Seventy consecutive PCI patients who met the inclusion criteria', 'patients with chronic diseases', 'Sixty-two patients completed the study', 'patients with percutaneous coronary intervention (PCI']","['waitlist control', 'telephone-adapted mindfulness intervention', 'MBSR', 'telephone-adapted mindfulness-based stress reduction', 'Mindfulness-based stress reduction (MBSR', 'telephone-adapted MBSR']","['anxiety and depression, stress, and mindfulness', 'Psychological distress and negative conditions', 'psychological symptoms', 'Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), and short form of the Freiburg Mindfulness Inventory (FMI-s', 'HADS', 'PSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",70.0,0.0253461,"Compared with the waitlist group, the MBSR group showed greater decreases in HADS (p = .006) and PSS (p = .035) scores.","[{'ForeName': 'Yunying', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Minxia', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'School of Nursing, Soochow University, Suzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Translational behavioral medicine,['10.1093/tbm/ibz130']
943,31504982,Role of good oral hygiene on clinical evolution of rheumatoid arthritis: a randomized study nested in the ESPOIR cohort.,"OBJECTIVE


There is a relationship between RA and periodontal disease. We aimed to investigate if a good oral hygiene could improve activity of RA.
METHODS


The patients with RA according to ACR/EULAR 2010 criteria and included in the French early arthritis ESPOIR cohort were included in a randomized nested study into: (i) intervention group: general recommendations of good oral hygiene including teeth brushing, daily antiseptic mouthwash and twice a year scaling; and (ii) control group: no intervention. The primary end point was the delta DAS28-ESR.
RESULTS


Four hundred and seventy-two patients were randomized (238 in intervention and 234 in control). 92/238 from the intervention group accepted the procedure and 81 had a first visit to the dentist. 56% of patients had periodontal disease at baseline. Duration of RA was 9.0±0.7 years. Baseline DAS28-ESR was 2.7±1.3. After a median duration of 24 months, delta DAS28-ESR was -0.17±1.29 and -0.09±1.28 in intervention and control groups, respectively (mean difference (complier average causal effect): -0.37 (95% CI -1.12, 0.37), P = 0.33). In the intervention group, there was a significant decrease of the bacteria involved in the red complex: Porphyromonas gingivalis (P = 0.002), Tannerella forsythia (P = 0.002) and Treponema denticola (P = 0.019). The patients with baseline periodontal disease and those who became negative for one red complex bacterium had a slightly more important decrease of DAS28-ESR.
CONCLUSION


Oral hygiene instruction together with regular scaling and polishing of the teeth significantly decreased the load of periodontal pathogens but did not decrease RA activity. This intervention should be tested in patients with earlier RA and more active disease.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT01831648.",2020,"In the intervention group, there was a significant decrease of the bacteria involved in the red complex: Porphyromonas gingivalis (P = 0.002), Tannerella forsythia (P = 0.002) and Treponema denticola (P = 0.019).","['patients with earlier RA and more active disease', 'rheumatoid arthritis', 'Four hundred and seventy-two patients were randomized (238 in intervention and 234 in control', 'patients with RA according to ACR/EULAR 2010 criteria and included in the French early arthritis ESPOIR cohort']","['good oral hygiene', 'intervention group: general recommendations of good oral hygiene including teeth brushing, daily antiseptic mouthwash and twice a year scaling; and (ii) control group: no intervention']","['DAS28-ESR', 'load of periodontal pathogens', 'bacteria involved in the red complex: Porphyromonas gingivalis', 'RA activity', 'Tannerella forsythia', 'Duration of RA', 'periodontal disease', 'delta DAS28-ESR', 'Treponema denticola']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}]","[{'cui': 'C0457639', 'cui_str': 'Good oral hygiene (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0314961', 'cui_str': 'Bacteroides forsythus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}]",472.0,0.0855377,"In the intervention group, there was a significant decrease of the bacteria involved in the red complex: Porphyromonas gingivalis (P = 0.002), Tannerella forsythia (P = 0.002) and Treponema denticola (P = 0.019).","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Sud, INSERM UMR1184, Le Kremlin Bicêtre.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Perrodeau', 'Affiliation': 'Department of Epidemiology, Université Paris-Descartes, Paris.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Verner', 'Affiliation': 'Department of Periodontology, University of Nantes, Nantes.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Struillou', 'Affiliation': 'Department of Periodontology, University of Nantes, Nantes.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Picard', 'Affiliation': 'Private Practice, Rouen.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Department of Rheumatology, Université de Bordeaux, Bordeaux.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Constantin', 'Affiliation': 'Department of Rheumatology, Hôpital Pierre-Paul Riquet and Université Toulouse III - Paul Sabatier, Toulouse.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': 'Department of Epidemiology, Université Paris-Descartes, Paris.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bouchard', 'Affiliation': 'Department of Periodontology, Service of Odontology, Rothschild Hospital, AP-HP, Denis Diderot University.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez368']
944,31846016,Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure: The GALACTIC Randomized Clinical Trial.,"Importance


Short-term infusions of single vasodilators, usually given in a fixed dose, have not improved outcomes in patients with acute heart failure (AHF).
Objective


To evaluate the effect of a strategy that emphasized early intensive and sustained vasodilation using individualized up-titrated doses of established vasodilators in patients with AHF.
Design, Setting, and Participants


Randomized, open-label blinded-end-point trial enrolling 788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Enrollment began in December 2007 and follow-up was completed in February 2019.
Interventions


Patients were randomized 1:1 to a strategy of early intensive and sustained vasodilation throughout the hospitalization (n = 386) or usual care (n = 402). Early intensive and sustained vasodilation was a comprehensive pragmatic approach of maximal and sustained vasodilation combining individualized doses of sublingual and transdermal nitrates, low-dose oral hydralazine for 48 hours, and rapid up-titration of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan.
Main Outcomes and Measures


The primary end point was a composite of all-cause mortality or rehospitalization for AHF at 180 days.
Results


Among 788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women) completed the trial and were eligible for primary end point analysis. Follow-up at 180 days was completed for 779 patients (99.7%). The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59). The most common clinically significant adverse events with early intensive and sustained vasodilation vs usual care were hypokalemia (23% vs 25%), worsening renal function (21% vs 20%), headache (26% vs 10%), dizziness (15% vs 10%), and hypotension (8% vs 2%).
Conclusions and Relevance


Among patients with AHF, a strategy of early intensive and sustained vasodilation, compared with usual care, did not significantly improve a composite outcome of all-cause mortality and AHF rehospitalization at 180 days.
Trial Registration


ClinicalTrials.gov Identifier: NCT00512759.",2019,"The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59).","['patients with AHF', '788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women', 'patients with acute heart failure (AHF', 'Patients With Acute Heart Failure', '788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain']","['Comprehensive Vasodilation vs Usual Care', 'strategy of early intensive and sustained vasodilation throughout the hospitalization (n\u2009=\u2009386) or usual care', 'sublingual and transdermal nitrates, low-dose oral hydralazine', 'angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan']","['Mortality and Heart Failure Rehospitalization', 'hypotension', 'hypokalemia', 'composite of all-cause mortality or rehospitalization for AHF', 'dizziness', 'headache', 'worsening renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020223', 'cui_str': 'Hydralazine'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",788.0,0.189306,"The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59).","[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Kozhuharov', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Assen', 'Initials': 'A', 'LastName': 'Goudev', 'Affiliation': 'Queen Ioanna University Hospital Sofia, Department of Cardiology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Dayana', 'Initials': 'D', 'LastName': 'Flores', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Micha T', 'Initials': 'MT', 'LastName': 'Maeder', 'Affiliation': 'Department of Cardiology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Samyut', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Danielle Menosi', 'Initials': 'DM', 'LastName': 'Gualandro', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mucio Tavares', 'Initials': 'MT', 'LastName': 'de Oliveira Junior', 'Affiliation': 'Heart Institute (INCOR), University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Sabti', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Department of General Internal and Emergency Medicine, Medical University Clinic of the University of Basel, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Noveanu', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thenral', 'Initials': 'T', 'LastName': 'Socrates', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Ziller', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genís', 'Affiliation': 'Heart Institute, Hospital Universitari Germans Trias i Pujol, CIBERCV, Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Intensive Cardiac Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, Biomedical Research Institute IIB-Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Clinical Trial Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Michou', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Gujer', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wenzel', 'Affiliation': 'University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Kapos', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kobza', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Rickli', 'Affiliation': 'Department of Cardiology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Breidthardt', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Erne', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': '', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': '', 'LastName': 'Erne', 'Affiliation': ''}, {'ForeName': 'Beat', 'Initials': '', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': '', 'LastName': 'Rickli', 'Affiliation': ''}, {'ForeName': 'Micha', 'Initials': '', 'LastName': 'Maeder', 'Affiliation': ''}, {'ForeName': 'Mucio', 'Initials': '', 'LastName': 'Tavares de Oliveira', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Münzel', 'Affiliation': ''}, {'ForeName': 'Antoni', 'Initials': '', 'LastName': 'Bayés-Genís', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': '', 'LastName': 'Sionis', 'Affiliation': ''}, {'ForeName': 'Assen', 'Initials': '', 'LastName': 'Goudev', 'Affiliation': ''}, {'ForeName': 'Bojidar', 'Initials': '', 'LastName': 'Dimov', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': '', 'LastName': 'Hartwiger', 'Affiliation': ''}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Arenja', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': '', 'LastName': 'Glatz', 'Affiliation': ''}, {'ForeName': 'Natascha', 'Initials': '', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': '', 'LastName': 'Isenrich', 'Affiliation': ''}, {'ForeName': 'Tamina', 'Initials': '', 'LastName': 'Mosimann', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': '', 'LastName': 'Twerenbold', 'Affiliation': ''}, {'ForeName': 'Jasper', 'Initials': '', 'LastName': 'Boeddinghaus', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Nestelberger', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': '', 'LastName': 'Puelacher', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': '', 'LastName': 'Freese', 'Affiliation': ''}, {'ForeName': 'Janine', 'Initials': '', 'LastName': 'Vögele', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': '', 'LastName': 'Meissner', 'Affiliation': ''}, {'ForeName': 'Jasmin', 'Initials': '', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Ivo', 'Initials': '', 'LastName': 'Strebel', 'Affiliation': ''}, {'ForeName': 'Desiree', 'Initials': '', 'LastName': 'Wussler', 'Affiliation': ''}, {'ForeName': 'Carmela', 'Initials': '', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': '', 'LastName': 'Osswald', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': '', 'LastName': 'Vogt', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Hilti', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': '', 'LastName': 'Barata', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': '', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Schwarz', 'Affiliation': ''}, {'ForeName': 'Brigitte', 'Initials': '', 'LastName': 'Fitze', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': '', 'LastName': 'Hartwiger', 'Affiliation': ''}, {'ForeName': 'Nisha', 'Initials': '', 'LastName': 'Arenja', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': '', 'LastName': 'Glatz', 'Affiliation': ''}, {'ForeName': 'Natascha', 'Initials': '', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': '', 'LastName': 'Isenrich', 'Affiliation': ''}, {'ForeName': 'Tamina', 'Initials': '', 'LastName': 'Mosimann', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': '', 'LastName': 'Twerenbold', 'Affiliation': ''}, {'ForeName': 'Jasper', 'Initials': '', 'LastName': 'Boeddinghaus', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Nestelberger', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': '', 'LastName': 'Puelacher', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': '', 'LastName': 'Freese', 'Affiliation': ''}, {'ForeName': 'Janine', 'Initials': '', 'LastName': 'Vögele', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': '', 'LastName': 'Meissner', 'Affiliation': ''}, {'ForeName': 'Jasmin', 'Initials': '', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Ivo', 'Initials': '', 'LastName': 'Strebel', 'Affiliation': ''}, {'ForeName': 'Desiree', 'Initials': '', 'LastName': 'Wussler', 'Affiliation': ''}, {'ForeName': 'Carmela', 'Initials': '', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': '', 'LastName': 'Osswald', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': '', 'LastName': 'Vogt', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Hilti', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': '', 'LastName': 'Barata', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': '', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Schwarz', 'Affiliation': ''}, {'ForeName': 'Brigitte', 'Initials': '', 'LastName': 'Fitze', 'Affiliation': ''}, {'ForeName': 'Nisha', 'Initials': '', 'LastName': 'Arenja', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': '', 'LastName': 'Rentsch', 'Affiliation': ''}, {'ForeName': 'Aline', 'Initials': '', 'LastName': 'Bossa', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': '', 'LastName': 'Jallad', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': '', 'LastName': 'Soeiro', 'Affiliation': ''}, {'ForeName': 'Dimitar', 'Initials': '', 'LastName': 'Georgiev', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Jansen', 'Affiliation': ''}, {'ForeName': 'Gabriele', 'Initials': '', 'LastName': 'Gebel', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': '', 'LastName': 'Bossard', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': '', 'LastName': 'Christ', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.18598']
945,14968725,Revisiting upper respiratory tract infection (URTI) in adults in the light of the current severe acute respiratory syndrome (SARS) situation in Singapore.,,2003,,['adults in the light of the current severe acute respiratory syndrome (SARS) situation in Singapore'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1175175', 'cui_str': 'SARS (Severe Acute Respiratory Syndrome)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]",[],[],,0.0176147,,"[{'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Tan', 'Affiliation': 'National Healthcare Group Polyclinics, Hougang Polyclinic, Singapore.'}, {'ForeName': 'C Y', 'Initials': 'CY', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Chong', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Lew', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Lin', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
946,32436612,"Safety, feasibility and efficacy of side-alternating vibration therapy on bone and muscle health in children and adolescents with musculoskeletal disorders: A pilot trial.","AIMS


A pilot study was performed to establish the safety, feasibility and efficacy of vibration therapy (VT) on bone and muscle health in children and adolescents with a range of musculoskeletal disorders.
METHODS


Seventeen participants (15.7 years ± 2.9 years), with conditions that impacted on their musculoskeletal health, completed 20 weeks of side-alternating VT for 9 min/session, 4 times/week at 20 Hz. Data were collected at baseline and after 20 weeks of intervention. Assessments included whole-body dual-energyX-ray absorptiometry, muscle function (force plate) and 6-min walk test.
RESULTS


Compliance with the prescribed VT training protocol was relatively high overall at 78% and there were no adverse events reported. After 20 weeks intervention, functional assessments showed time taken to perform the chair test was reduced by 15% (P = 0.018), leg balance improved with standard ellipse area decreasing by 88% (P = 0.006) and distance walked in the 6-min walk test improved by 9% (P = 0.002). Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19). There was no change in total body bone mineral density (P = 0.44) or bone mineral content (P = 0.07).
CONCLUSIONS


Twenty weeks of side-alternating VT was a feasible protocol that was associated with improvements in physical function and no detrimental effects on lean mass, bone mass or density in children and adolescents with musculoskeletal disorders.",2020,Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19).,"['Seventeen participants (15.7\u2009years\u2009±\u20092.9\u2009years), with conditions that impacted on their musculoskeletal health, completed 20\u2009weeks of side-alternating VT for 9 min/session, 4 times/week at 20\u2009Hz', 'children and adolescents with a range of musculoskeletal disorders', 'children and adolescents with musculoskeletal disorders']","['vibration therapy (VT', 'side-alternating vibration therapy']","['lean mass, bone mass or density', 'physical function', 'whole-body dual-energyX-ray absorptiometry, muscle function (force plate) and 6-min walk test', 'lean mass', 'distance walked in the 6-min walk test', 'total body mass', 'time taken to perform the chair test', 'safety, feasibility and efficacy', 'Safety, feasibility and efficacy', 'bone mineral content', 'bone and muscle health', 'total body bone mineral density', 'leg balance']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",17.0,0.0430062,Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19).,"[{'ForeName': 'Renuka M', 'Initials': 'RM', 'LastName': 'Vesey', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'José Gb', 'Initials': 'JG', 'LastName': 'Derraik', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Colle', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Janene B', 'Initials': 'JB', 'LastName': 'Biggs', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Craig F', 'Initials': 'CF', 'LastName': 'Munns', 'Affiliation': ""Endocrinology Department, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.""}, {'ForeName': 'Wayne S', 'Initials': 'WS', 'LastName': 'Cutfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Silmara', 'Initials': 'S', 'LastName': 'Gusso', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}]",Journal of paediatrics and child health,['10.1111/jpc.14913']
947,31503086,Additive Effect of Topical Nepafenac on Mydriasis in Patients With Diabetes Mellitus.,"OBJECTIVES


To evaluate the additive effect of topical nepafenac on pupil diameter (PD) in patients with diabetes mellitus (DM) and cataract.
METHODS


This prospective comparative study included the patients having cataract surgery with and without DM. Two consecutive PD measurements were taken using an automatic quantitative pupillometry system (MonPack One, Metrovision). A baseline measurement was taken, then one drop of nepafenac % 0.1 (Nevanac; Alcon, Fort Worth, TX) was instilled only to the eye that will be operated on (study eye). Cyclopentolate 1.0% (Sikloplejin; Abdi İbrahim, İstanbul, Turkey) was instilled to both eyes (study eye/fellow eye) 5 minutes later. The second measurement was taken at 1 hour after this application.
RESULTS


The DM group consisted of 43 patients, and the control group consisted of 39 participants. The baseline PDs of both eyes were similar in the DM group (P=0.070) and the control group (P=0.345). The change in pupil size from baseline to mydriasis was statistically significantly greater in the study eyes (2.69±0.53) than fellow eyes (2.54±0.61) in the DM group (P=0.009), but there was no statistically significant difference in the control group (2.94±0.63 vs. 2.86±0.58). When the groups were compared, the PD changes were similar in the study eyes between groups (P=0.065), while the PD changes in the fellow eyes were lower in the DM group (P=0.017).
CONCLUSIONS


Nepafenac has been shown additive effect on pupil dilation in diabetic patients before cataract surgery.",2020,The baseline PDs of both eyes were similar in the DM group (P=0.070) and the control group (P=0.345).,"['patients with diabetes mellitus (DM) and cataract', 'Patients With Diabetes Mellitus', 'patients having cataract surgery with and without DM', 'diabetic patients before cataract surgery']","['Cyclopentolate', 'Nepafenac', 'topical nepafenac', 'Topical Nepafenac', 'nepafenac % 0.1 (Nevanac; Alcon, Fort Worth, TX']","['pupil dilation', 'Mydriasis', 'change in pupil size from baseline to mydriasis', 'PD changes', 'pupil diameter (PD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0010582', 'cui_str': 'Cyclopentolate'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1612191', 'cui_str': 'Nevanac'}]","[{'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]",39.0,0.0380444,The baseline PDs of both eyes were similar in the DM group (P=0.070) and the control group (P=0.345).,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Kiziltoprak', 'Affiliation': ""Ophthalmology Department (H.K.), Bingol Women's Health and Children's Hospital, Bingol, Turkey; Ophthalmology Department (M.K., E.Y.), Ankara Ulucanlar Eye Training and Research Hospital, Ankara, Turkey; Ophthalmology Department (K.T., M.I.), Ercis State Hospital, Van, Turkey; and Ophthalmology Department (K.O.), TOBB ETU Hospital, Ankara, Turkey.""}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Koc', 'Affiliation': ''}, {'ForeName': 'Esat', 'Initials': 'E', 'LastName': 'Yetkin', 'Affiliation': ''}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Tekin', 'Affiliation': ''}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Inanc', 'Affiliation': ''}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Ozulken', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000657']
948,31501493,Effect of angiotensin II receptor blocker and salt supplementation on short-term blood pressure variability in type 2 diabetes.,"High blood pressure variability (BPV) has been associated with increased cardiovascular (CV) risk. The effect of dietary salt and renin-angiotensin-aldosterone system (RAAS) activity on short-term BPV in type 2 diabetes mellitus (T2DM) is not well characterised. We aimed to determine the effect of dietary salt (sodium chloride, NaCl) supplementation on 24-h mean arterial BPV (24hBPV) during angiotensin II receptor blocker (telmisartan) use and to evaluate the effects of age, sex, plasma renin activity (PRA) and serum aldosterone on 24hBPV. In a randomised, double-blind, crossover study, patients with T2DM (n = 28), treated with telmisartan received NaCl (100 mmol/24 h) or placebo capsules during 2 weeks of telmisartan. Following a 6-week washout, the protocol was repeated in reverse. 24hBPV was evaluated as a co-efficient of variation [CV (%) = mean/standard deviation] × 100). Twenty-four hour urinary sodium excretion, ambulatory BP and biochemical tests were performed at each phase. Results were analysed using a linear mixed model to generate predicted values for 24hBPV. Predicted 24hBPV was higher with telmisartan vs baseline (p = 0.01), with a trend towards reduced 24hBPV with salt (p = 0.052). Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011). In patients with T2DM, predicted 24hBPV increased from baseline with telmisartan, but there was no additional increase in predicted 24hBPV with salt supplementation. This suggests that in the short-term, salt supplementation has no apparent deleterious effects on 24hBPV. Long-term studies are required to evaluate the effect of 24hBPV on CV outcomes in patients with T2DM.",2020,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","['patients with T2DM (n\u2009=\u200928), treated with', 'type 2 diabetes', 'type 2 diabetes mellitus (T2DM', 'patients with T2DM']","['telmisartan', 'telmisartan received NaCl', '24hBPV', 'dietary salt (sodium chloride, NaCl) supplementation', 'placebo', 'angiotensin II receptor blocker and salt supplementation', 'angiotensin II receptor blocker (telmisartan', 'dietary salt and renin-angiotensin-aldosterone system (RAAS) activity']","['urinary sodium excretion, ambulatory BP and biochemical tests', 'Predicted 24hBPV', 'cardiovascular (CV) risk', '24hBPV', 'CV outcomes', 'High blood pressure variability (BPV', 'short-term blood pressure variability', 'PRA', '24-h mean arterial BPV (24hBPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",,0.0546638,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Moran', 'Affiliation': 'Queen Elizabeth Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Libianto', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baqar', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Callaghan"", 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jerums', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia. elif.ekinci@unimelb.edu.au.'}]",Journal of human hypertension,['10.1038/s41371-019-0238-3']
949,31454045,Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial.,"Importance


Induction chemotherapy followed by high-dose therapy with autologous stem cell transplant and subsequent antidisialoganglioside antibody immunotherapy is standard of care for patients with high-risk neuroblastoma, but survival rate among these patients remains low.
Objective


To determine if tandem autologous transplant improves event-free survival (EFS) compared with single transplant.
Design, Setting, and Participants


Patients were enrolled in this randomized clinical trial from November 2007 to February 2012 at 142 Children's Oncology Group centers in the United States, Canada, Switzerland, Australia, and New Zealand. A total of 652 eligible patients aged 30 years or younger with protocol-defined high-risk neuroblastoma were enrolled and 355 were randomized. The final date of follow-up was June 29, 2017, and the data analyses cut-off date was June 30, 2017.
Interventions


Patients were randomized to receive tandem transplant with thiotepa/cyclophosphamide followed by dose-reduced carboplatin/etoposide/melphalan (n = 176) or single transplant with carboplatin/etoposide/melphalan (n = 179).
Main Outcomes and Measures


The primary outcome was EFS from randomization to the occurrence of the first event (relapse, progression, secondary malignancy, or death from any cause). The study was designed to test the 1-sided hypothesis of superiority of tandem transplant compared with single transplant.
Results


Among the 652 eligible patients enrolled, 297 did not undergo randomization because they were nonrandomly assigned (n = 27), ineligible for randomization (n = 62), had no therapy (n = 1), or because of physician/parent preference (n = 207). Among 355 patients randomized (median diagnosis age, 36.1 months; 152 [42.8%] female), 297 patients (83.7%) completed the study and 21 (5.9%) were lost to follow-up after completing protocol therapy. Three-year EFS from the time of randomization was 61.6% (95% CI, 54.3%-68.9%) in the tandem transplant group and 48.4% (95% CI, 41.0%-55.7%) in the single transplant group (1-sided log-rank P=.006). The median (range) duration of follow-up after randomization for 181 patients without an event was 5.6 (0.6-8.9) years. The most common significant toxicities following tandem vs single transplant were mucosal (11.7% vs 15.4%) and infectious (17.9% vs 18.3%).
Conclusions and Relevance


Among patients aged 30 years or younger with high-risk neuroblastoma, tandem transplant resulted in a significantly better EFS than single transplant. However, because of the low randomization rate, the findings may not be representative of all patients with high-risk neuroblastoma.
Trial Registration


ClinicalTrials.gov Identifier: NCT00567567.",2019,"The most common significant toxicities following tandem vs single transplant were mucosal (11.7% vs 15.4%) and infectious (17.9% vs 18.3%).
","['Patients', 'With High-Risk Neuroblastoma', '652 eligible patients aged 30 years or younger with protocol-defined high-risk neuroblastoma were enrolled and 355 were randomized', 'patients aged 30 years or younger with high-risk neuroblastoma', '355 patients randomized (median diagnosis age, 36.1 months; 152 [42.8%] female), 297 patients (83.7%) completed the study and 21 (5.9%) were lost to follow-up after completing protocol therapy', '652 eligible patients enrolled, 297 did not undergo randomization because they were nonrandomly assigned (n\u2009=\u200927), ineligible for randomization (n\u2009=\u200962), had no therapy (n\u2009=\u20091), or because of physician/parent preference (n\u2009=\u2009207', 'patients with high-risk neuroblastoma', ""Participants\n\n\nPatients were enrolled in this randomized clinical trial from November 2007 to February 2012 at 142 Children's Oncology Group centers in the United States, Canada, Switzerland, Australia, and New Zealand""]","['tandem transplant with thiotepa/cyclophosphamide followed by dose-reduced carboplatin/etoposide/melphalan (n\u2009=\u2009176) or single transplant with carboplatin/etoposide/melphalan', 'autologous stem cell transplant and subsequent antidisialoganglioside antibody immunotherapy', 'Tandem Autologous Stem Cell Transplant vs Single Transplant']","['toxicities', 'survival rate', 'median (range) duration', 'EFS from randomization to the occurrence of the first event (relapse, progression, secondary malignancy, or death from any cause', 'event-free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0039871', 'cui_str': 'Thiotepa'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",142.0,0.20889,"The most common significant toxicities following tandem vs single transplant were mucosal (11.7% vs 15.4%) and infectious (17.9% vs 18.3%).
","[{'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kreissman', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Department of Pediatrics, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Department of Biostatistics, University of Florida, Children's Oncology Group Statistics and Data Center, Gainesville.""}, {'ForeName': 'Susan Lerner', 'Initials': 'SL', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Department of Pediatrics Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.""}, {'ForeName': 'Sheena C', 'Initials': 'SC', 'LastName': 'Tenney', 'Affiliation': ""Department of Biostatistics, University of Florida, Children's Oncology Group Statistics and Data Center, Gainesville.""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana Farber/Brigham and Women's Cancer Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Peter John', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': ""Bone Marrow Transplant, Children's Hospital at Westmead, Sydney, Australia.""}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Kraveka', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Roberts', 'Affiliation': 'Department of Pediatrics, Memorial Sloan Kettering Cancer Center, Manhattan, New York.'}, {'ForeName': 'James Duncan', 'Initials': 'JD', 'LastName': 'Geiger', 'Affiliation': ""Section of Pediatric Surgery, CS Mott Children's Hospital, Michigan Medicine, Ann Arbor.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Doski', 'Affiliation': 'Departments of Surgery and Pediatrics, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Stephan D', 'Initials': 'SD', 'LastName': 'Voss', 'Affiliation': ""Department of Radiology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Maris', 'Affiliation': ""Department of Pediatrics Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.""}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Department of Pediatrics Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Diller', 'Affiliation': ""Department of Pediatrics, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2019.11642']
950,31494097,"Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: a phase 2a, randomised, double-blind, placebo-controlled, parallel-group study.","BACKGROUND


Refractory coeliac disease type 2 is a rare subtype of coeliac disease with high mortality rates; interleukin 15 (IL-15) is strongly implicated in its pathophysiology. This trial aimed to investigate the effects of AMG 714, an anti-IL-15 monoclonal antibody, on the activity and symptoms of refractory coeliac disease type 2.
METHODS


This was a randomised, double-blind, placebo-controlled, phase 2a study of adults with a confirmed diagnosis of refractory coeliac disease type 2. Patients were randomly assigned at a 2:1 ratio to receive seven intravenous doses over 10 weeks of AMG 714 (8 mg/kg) or matching placebo. Biopsy samples were obtained at baseline and week 12 for cellular analysis and histology. The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry. Secondary endpoints were the change in aberrant intraepithelial lymphocytes with respect to intestinal epithelial cells; intestinal histological scores (villous height-to-crypt depth ratio; VHCD); intraepithelial lymphocyte counts; Marsh score; and patient-reported symptom measures, including the Bristol stool form scale (BSFS) and gastrointestinal symptom rating scale (GSRS). Main analyses were done in the per-protocol population of patients who received their assigned treatment, provided evaluable biopsy samples, and did not have major protocol deviations; only patients with non-atypical disease were included in the analyses of aberrant intraepithelial lymphocytes, including the primary analysis. Safety was assessed in all patients who received at least one dose of study drug. This study is registered at ClinicalTrials.gov (NCT02633020) and EudraCT (2015-004063-36).
FINDINGS


From April 13, 2016, to Jan 19, 2017, 28 patients were enrolled and randomly assigned to AMG 714 (n=19) and placebo (n=9). Six patients were not included in the primary analysis because of protocol deviation (one in the AMG 714 group), insufficient biopsy samples (one in the AMG 714 group), and atypical intraepithelial lymphocytes (three in the AMG 714 group and one in the placebo group). At 12 weeks, the least square mean difference between AMG 714 and placebo in the relative change from baseline in aberrant intraepithelial lymphocyte percentage was -4·85% (90% CI -30·26 to 20·56; p=0·75). The difference between the AMG 714 and placebo groups in aberrant intraepithelial lymphocytes with respect to epithelial cells at 12 weeks was -38·22% (90% CI -95·73 to 19·29; nominal p=0·18); the difference in change in Marsh score from baseline was 0·09% (95% CI -1·60-1·90; nominal p=0·92); the difference in VHCD ratio was 10·67% (95% CI -38·97 to 60·31; nominal p=0·66); and the difference in change in total intraepithelial lymphocyte count was -12·73% (95% CI -77·57-52·12); nominal p=0·69). Regarding symptoms, the proportion of patients with diarrhoea per the BSFS score decreased from ten (53%) of 19 at baseline to seven (37%) of 19 at week 12 in the AMG 714 group and increased from two (22%) of nine at baseline to four (44%) of nine at week 12 in the placebo group (nominal p=0·0008); and the difference between the groups in change in GSRS score was -0·14 (SE 0·19; nominal p=0·48). Eight (89%) patients in the placebo group and 17 (89%) in the AMG 714 group had treatment-emergent adverse events, including one (11%) patient in the placebo group and five (26%) in the AMG 714 group who had serious adverse events. The most common adverse event in the AMG 714 group was nasopharyngitis (eight [42%] patients vs one [11%] in the placebo group).
INTERPRETATION


In patients with refractory coeliac disease type 2 who were treated with AMG 714 or placebo for 10 weeks, there was no difference between the groups in terms of the primary endpoint of aberrant intraepithelial lymphocyte reduction from baseline. Effects on symptoms and other endpoints suggest that further research of AMG 714 may be warranted in patients with refractory coeliac disease type 2.
FUNDING


Celimmune and Amgen.",2019,The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry.,"['adults with a confirmed diagnosis of refractory coeliac disease type 2', 'patients with refractory coeliac disease type 2 who were treated with', 'patients with type 2 refractory coeliac disease', 'patients with refractory coeliac disease type 2', 'Six patients were not included in the primary analysis because of protocol deviation (one in the AMG 714 group), insufficient biopsy samples (one in the AMG 714 group), and atypical intraepithelial lymphocytes (three in the AMG 714 group and one in the placebo group', 'From April 13, 2016, to Jan 19, 2017, 28 patients']","['AMG 714 (8 mg/kg) or matching placebo', 'AMG', 'placebo', 'EudraCT', 'AMG 714 or placebo']","['BSFS score', 'GSRS score', 'Safety', 'VHCD ratio', 'Safety and efficacy', 'proportion of aberrant intraepithelial lymphocytes', 'aberrant intraepithelial lymphocytes with respect to epithelial cells', 'nasopharyngitis', 'treatment-emergent adverse events', 'change in aberrant intraepithelial lymphocytes with respect to intestinal epithelial cells; intestinal histological scores (villous height-to-crypt depth ratio; VHCD); intraepithelial lymphocyte counts; Marsh score; and patient-reported symptom measures, including the Bristol stool form scale (BSFS) and gastrointestinal symptom rating scale (GSRS', 'aberrant intraepithelial lymphocyte reduction', 'total intraepithelial lymphocyte count', 'aberrant intraepithelial lymphocyte percentage', 'serious adverse events', 'change in Marsh score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample (specimen)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1721089', 'cui_str': 'Marshes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",714.0,0.631348,The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry.,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cellier', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France. Electronic address: christophe.cellier@aphp.fr.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bouma', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van Gils', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Sherine', 'Initials': 'S', 'LastName': 'Khater', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Malamut', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Crespo', 'Affiliation': 'Department of Gastroenterology, University Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': 'Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Peter H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Celiac Disease Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sheila E', 'Initials': 'SE', 'LastName': 'Crowe', 'Affiliation': 'Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Butz', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Cerf-Bensussan', 'Affiliation': 'Laboratory of Intestinal Immunity and Institut Imagine, Paris, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Macintyre', 'Affiliation': 'Haematology, Université Paris Descartes, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leon', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA; Provention Bio, Oldwick, NJ, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Haematology, Université Paris Descartes, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Mulder', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30265-1']
951,32433753,Single-dose pharmacokinetics of temocillin in plasma and soft tissues of healthy volunteers after intravenous and subcutaneous administration: a randomized crossover microdialysis trial.,"BACKGROUND


The antibiotic temocillin has recently been rediscovered as a promising therapeutic option against MDR Gram-negative bacteria. However, some aspects of the pharmacokinetic (PK) profile of the drug are still to be elucidated: subcutaneous administration of temocillin might be of interest as an alternative to the intravenous route in selected patients. Similarly, information on the penetration of temocillin into human soft tissues is lacking.
OBJECTIVES


To investigate the feasibility and plasma PK of subcutaneous dosing as well as soft tissue PK of temocillin after intravenous administration to healthy volunteers.
METHODS


Eight healthy volunteers received 2 g of temocillin both as intravenous and subcutaneous infusion in a randomized two-period crossover study. Concentration-time profiles of total temocillin in plasma (after both routes) and of unbound temocillin in plasma, muscle and subcutis (only after intravenous dosing) were determined up to 12 h post-dose.
RESULTS


Subcutaneous dosing caused some infusion site discomfort but resulted in sustained drug concentrations over time with only slightly decreased overall exposure compared with intravenous dosing. Plasma protein binding of temocillin showed concentration-dependent behaviour and was higher than previously reported. Still, unbound drug concentrations in muscle and subcutis determined by microdialysis markedly exceeded those in plasma, suggesting good tissue penetration of temocillin.
CONCLUSIONS


The subcutaneous administration of temocillin is a valid and feasible alternative to intravenous dosing. With the description of plasma protein binding and soft tissue PK of temocillin in healthy volunteers, this study provides important information that adds to the ongoing characterization of the PK profile of temocillin and might serve as input for PK/PD considerations.",2020,"RESULTS


Subcutaneous dosing caused some infusion site discomfort but resulted in sustained drug concentrations over time with only slightly decreased overall exposure compared with intravenous dosing.","['Eight healthy volunteers', 'healthy volunteers', 'healthy volunteers after intravenous and subcutaneous administration']","['temocillin', '2\u2009g of temocillin both as intravenous and subcutaneous infusion']",['infusion site discomfort'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0076079', 'cui_str': 'temocillin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0576773', 'cui_str': 'Subcutaneous infusion'}]","[{'cui': 'C2721735', 'cui_str': 'Infusion site discomfort'}]",8.0,0.0220943,"RESULTS


Subcutaneous dosing caused some infusion site discomfort but resulted in sustained drug concentrations over time with only slightly decreased overall exposure compared with intravenous dosing.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Matzneller', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Perrin', 'Initials': 'P', 'LastName': 'Ngougni Pokem', 'Affiliation': 'Pharmacologie cellulaire et moléculaire, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Capron', 'Affiliation': 'Clinical Chemistry Department, Cliniques Universitaires St. Luc, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lackner', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Wulkersdorfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Nussbaumer-Pröll', 'Affiliation': 'Department of Medicine 1, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Österreicher', 'Affiliation': 'Department of Medicine 1, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Duchek', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Van de Velde', 'Affiliation': 'EUMEDICA S.A. Manage, Belgium.'}, {'ForeName': 'Pierre E', 'Initials': 'PE', 'LastName': 'Wallemacq', 'Affiliation': 'Clinical Chemistry Department, Cliniques Universitaires St. Luc, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Van Bambeke', 'Affiliation': 'Pharmacologie cellulaire et moléculaire, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa176']
952,31494096,"Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study.","BACKGROUND


Interleukin 15 (IL-15) is implicated in the pathophysiology of coeliac disease. AMG 714 is the first anti-IL-15 monoclonal antibody to be investigated for the treatment of coeliac disease. We aimed to investigate the effects of AMG 714 in patients with coeliac disease who underwent gluten challenge.
METHODS


This randomised, double-blind, placebo-controlled, parallel-group, phase 2a trial was done at three clinical sites in Finland. Inclusion criteria included age 18-80 years, a confirmed diagnosis of coeliac disease, and adherence to a gluten-free diet for at least 12 months before screening. Patients were randomly assigned (1:1:1) to 150 mg AMG 714, 300 mg AMG 714, or placebo using permuted blocks and stratified by study site and sex. Patients and study staff were masked to treatment assignment. Treatments were administered by two subcutaneous injections every 2 weeks for 10 weeks (total six doses). Patients without severe villous atrophy at baseline received a gluten challenge (2-4 g daily) during weeks 2-12. Small bowel biopsy samples were obtained for histological assessments at baseline and week 12. The primary efficacy endpoint was the percentage change from baseline to week 12 in villous height-to-crypt depth (VHCD) ratio. Secondary endpoints were CD3-positive intraepithelial lymphocyte density; clinical symptoms measured by gastrointestinal symptom rating scale (GSRS), coeliac disease GSRS, and Bristol stool form scale (BSFS); and changes in anti-tTG and anti-DGP antibodies from baseline. The primary analysis was done in the per-protocol 1 population of patients who received at least one dose of study drug and who underwent the gluten challenge. Safety analyses were done in all patients who received at least one dose of study drug. This trial is registered at ClinicalTrials.gov, NCT02637141 and EudraCT, 2015-003647-19.
FINDINGS


Between April 13, 2016, and Nov 22, 2016, 64 patients were enrolled and randomly assigned to either the 150 mg AMG 714 group (n=22), the 300 mg AMG 714 group (n=22), or the placebo group (n=20). Two patients did not start treatment and two did not provide post-treatment biopsy samples. 49 patients underwent the gluten challenge (per-protocol 1 population) and 11 patients did not because of baseline villous atrophy. AMG 714 did not prevent mucosal injury due to gluten challenge. The least square mean difference in the relative change from baseline in VHCD ratio was -2·49% (95% CI -16·82 to 11·83; p=0·73) between 150 mg AMG 714 and placebo and 6·39% (-7·07 to 19·85; p=0·34) between 300 mg AMG 714 and placebo. Neither comparison was statistically significant. The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47). Clinical symptoms were ameliorated with AMG 714 treatment between baseline and week 12, particularly diarrhoea as measured by the BSFS (nominal p=0·01 for 150 mg vs placebo, and nominal p=0·0002 for 300 mg vs placebo). Serum antibody titres for anti-tTG and anti-DGP antibodies increased in all three treatment groups, with no significant difference between AMG 714 and placebo. Treatment-emergent adverse events occurred in 21 (95%) patients in the 150 mg AMG 714 group, 0 (95%) in the 300 mg AMG 714 group, and 19 (100%) in the placebo group. The most common treatment-emergent adverse events were gastrointestinal disorders (17 [77%] participants in the 150 mg AMG 714 group, 16 [76%] in the 300 mg AMG 714 group, and 13 [68%] in the placebo group). Injection site reactions were the most common individual adverse event, reported in eight (36%) patients in the 150 mg AMG 714 group, 11 (52%) in the 300 mg group, and five (26%) in the placebo group. No serious adverse events occurred.
INTERPRETATION


The primary endpoint, change in VHCD ratio from baseline after 12 weeks of treatment in patients with coeliac disease undergoing gluten challenge, was not significantly different between placebo and AMG 714 at either 150 mg or 300 mg. Effects on intraepithelial lymphocyte density and symptoms suggest that further research of AMG 714 may be warranted in patients with non-responsive coeliac disease.
FUNDING


Celimmune and Amgen.",2019,"The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47).","['Inclusion criteria included age 18-80 years, a confirmed diagnosis of coeliac disease, and adherence to a gluten-free diet for at least 12 months before screening', 'patients with non-responsive coeliac disease', 'Between April 13, 2016, and Nov 22, 2016, 64 patients', 'adults with coeliac disease exposed to gluten challenge', '49 patients underwent the gluten challenge (per-protocol 1 population) and 11 patients did not because of baseline villous atrophy', 'patients with coeliac disease who underwent gluten challenge']","['placebo', 'AMG', 'AMG 714, 300 mg AMG 714, or placebo']","['Small bowel biopsy samples', 'adverse events', 'VHCD ratio', 'diarrhoea', 'percentage change from baseline to week 12 in villous height-to-crypt depth (VHCD) ratio', 'severe villous atrophy', 'Safety and efficacy', 'CD3-positive intraepithelial lymphocyte density; clinical symptoms measured by gastrointestinal symptom rating scale (GSRS), coeliac disease GSRS, and Bristol stool form scale (BSFS); and changes in anti-tTG and anti-DGP antibodies', 'Serum antibody titres for anti-tTG and anti-DGP antibodies', 'change in VHCD ratio', 'Clinical symptoms', 'density of CD3-positive intraepithelial lymphocytes', 'gastrointestinal disorders']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0554101', 'cui_str': 'Villous atrophy (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample (specimen)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0554101', 'cui_str': 'Villous atrophy (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]",714.0,0.486434,"The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47).","[{'ForeName': 'Marja-Leena', 'Initials': 'ML', 'LastName': 'Lähdeaho', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'Clinical Research Services Turku, Turku, Finland; Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Vuotikka', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Taavela', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; Department of Internal Medicine, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Popp', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; University of Medicine and Pharmacy ""Carol Davila"", Bucharest, Romania.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Laukkarinen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Koffert', 'Affiliation': 'Department of Gastroenterology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli-Pekka', 'Initials': 'OP', 'LastName': 'Koivurova', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Pesu', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kivelä', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'Clinical Research Services Turku, Turku, Finland.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Keisala', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Isola', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; Tampere Center for Child Health Research, Tampere University and University Hospital, Jilab, Tampere, Finland.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leon', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Celimmune, Bethesda, MD, USA; Tampere Center for Child Health Research, Tampere University and University Hospital, Provention Bio, Oldwick, NJ, USA. Electronic address: fleon@proventionbio.com.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Mäki', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30264-X']
953,31859197,Comparison of intradermal mesotherapy with systemic therapy in the treatment of low back pain: A prospective randomized study.,"INTRODUCTION


Musculoskeletal pain such as low back pain (LBP) are routinely encountered in the ED and contribute to ED overcrowding. The aim of our study was to compare the efficiency of mesotherapy with systemic therapy in pain control in patients with lumbar disk herniation.
METHODS


We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with low back pain related to herniated lumbar disk. Mesotherapy was performed to one group, while intravenous dexketoprofen was administered to the control group. Changes in pain intensity at 15th minute, 30th minute, 60th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 h after treatment, and adverse effect of the treatment methods were compared between groups.
RESULTS


The decreases in pain intensity were statistically significantly higher in mesotherapy group for all time intervals. The need to use analgesics was statistically significantly three fold higher in the systemic therapy group. There was no statistically significant difference in having any adverse effect between study groups during one-week follow-up period.
CONCLUSIONS


Changes in medical practices, from the systemic administration of NSAIDs to the minimally invasive techniques such as mesotherapy with potent efficacy and minimal side effects, may enhance the ability of EDs to meet the waiting time targets and improve patient's satisfaction.",2020,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"['low back pain', 'patients with lumbar disk herniation', 'patients admitted to the emergency department with low back pain related to herniated lumbar disk']","['intradermal mesotherapy with systemic therapy', 'mesotherapy with systemic therapy', 'dexketoprofen', 'Mesotherapy']","['Visual Analogue Scale (VAS), need to use analgesic drug', 'pain intensity', 'adverse effect']","[{'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0708111,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"[{'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingöl State Hospital, Bingöl, Turkey. Electronic address: akbasilker@gmail.com.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.044']
954,31859346,Effectiveness and safety over 3 years after the 2-year U-Act-Early trial of the strategies initiating tocilizumab and/or methotrexate.,"OBJECTIVES


U-Act-Early was a 2-year, randomized placebo controlled, double-blind trial, in which DMARD-naïve early RA patients were treated to the target of sustained remission (SR). Two strategies initiating tocilizumab (TCZ), with and without methotrexate (MTX), were more effective than a strategy initiating MTX. The aim of the current study was to determine longer-term effectiveness in daily clinical practice.
METHODS


At the end of U-Act-Early, patients were included in a 3-year post-trial follow-up (PTFU), in which treatment was according to standard care and data were collected every 3 months during the first year and every 6 months thereafter. Primary end point was disease activity score assessing 28 joints (DAS28) over time. Mixed effects models were used to compare effectiveness between initial strategy groups, correcting for relevant confounders. Between the groups as randomized, proportions of patients were tested for DMARD use, SR and radiographic progression of joint damage.
RESULTS


Of patients starting U-Act-Early, 226/317 (71%) participated in the PTFU. Over the total 5 years, mean DAS28 was similar between groups (P > 0.20). During U-Act-Early, biologic DMARD use decreased in both TCZ initiation groups and increased in the MTX initiation group, but during follow-up this trend did not continue. SR was achieved at least once in 99% of patients. Of the 226 patients, only 30% had any radiographic progression over 5 years, without significant differences between the groups.
CONCLUSION


Although in the short-term the strategies initiating TCZ yielded the most clinical benefit, in the longer-term differences in important clinical outcomes between the strategies disappeared, probably due to continuation of the treat-to-target principle.",2020,"Over the total 5 years, mean DAS28 was similar between groups (P > 0.20).",[],"['placebo', 'tocilizumab and/or methotrexate', 'TCZ', 'tocilizumab (TCZ), with and without methotrexate (MTX']","['DMARD use, SR and radiographic progression of joint damage', 'biologic DMARD use', 'disease activity score assessing 28 joints (DAS28) over time', 'mean DAS28', 'radiographic progression', 'SR', 'Effectiveness and safety']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",226.0,0.180418,"Over the total 5 years, mean DAS28 was similar between groups (P > 0.20).","[{'ForeName': 'Maxime M A', 'Initials': 'MMA', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Tekstra', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Paco M J', 'Initials': 'PMJ', 'LastName': 'Welsing', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Pethö-Schramm', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Michelle E A', 'Initials': 'MEA', 'LastName': 'Borm', 'Affiliation': 'Roche Nederland BV, Woerden.'}, {'ForeName': 'George A W', 'Initials': 'GAW', 'LastName': 'Bruyn', 'Affiliation': 'Department of Rheumatology, MC Group, Lelystad.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Bos', 'Affiliation': 'Department of Rheumatology, Medical Center Leeuwarden, Leeuwarden.'}, {'ForeName': 'Ed N', 'Initials': 'EN', 'LastName': 'Griep', 'Affiliation': 'Department of Rheumatology, Antonius Hospital, Sneek.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Klaasen', 'Affiliation': 'Department of Rheumatology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'van Laar', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Floris P J G', 'Initials': 'FPJG', 'LastName': 'Lafeber', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes W J', 'Initials': 'JWJ', 'LastName': 'Bijlsma', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Marjolein J H', 'Initials': 'MJH', 'LastName': 'de Hair', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes W G', 'Initials': 'JWG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez602']
955,31462629,Enzyme-treated orange pomace alters acute glycemic response to orange juice.,"The goal of the present study was to determine the impact of the addition of enzyme-treated orange pomace to orange juice on postprandial glycemic response. Ten healthy subjects (aged 27.9 ± 7.7 years, body mass index 22.1 ± 1.1 kg m -2 ) participated in a randomized, 2-arm, cross-over clinical trial to test the glycemic response to 100% orange juice (OJ) or 100% orange juice with 5 g of enzyme-treated orange pomace fiber (OPF). Blood samples were collected and glucose and insulin concentrations were measured at fasting (0 min) and every 15 min for 2 h after consuming the study juice products. Analysis of the 2 h incremental area under the curve (iAUC 0-2h ) indicated a significant reduction in blood glucose after ingesting the OPF juice compared to the OJ, p = 0.02. Peak glucose concentrations were also lowered after the OPF juice compared to the OJ, p < 0.05. No significant difference was observed in insulin responses between treatments, p > 0.05. Overall, this study demonstrated that adding 5 g of fiber from orange pomace into a serving of OJ attenuated the postprandial glucose response.",2019,"Peak glucose concentrations were also lowered after the OPF juice compared to the OJ, p < 0.05.","['Ten healthy subjects (aged 27.9\u2009±\u20097.7 years, body mass index 22.1\u2009±\u20091.1\u2009kg\u2009m -2 ']","['enzyme-treated orange pomace to orange juice', 'glycemic response to 100% orange juice (OJ) or 100% orange juice with 5\u2009g of enzyme-treated orange pomace fiber (OPF', 'Enzyme-treated orange pomace']","['blood glucose', 'postprandial glucose response', 'Peak glucose concentrations', 'postprandial glycemic response', 'glucose and insulin concentrations', 'insulin responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}]","[{'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",10.0,0.0276964,"Peak glucose concentrations were also lowered after the OPF juice compared to the OJ, p < 0.05.","[{'ForeName': 'Yancui', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Replogle', 'Affiliation': 'PepsiCo R&D, Chicago, IL, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boileau', 'Affiliation': 'PepsiCo R&D, Chicago, IL, USA.'}, {'ForeName': 'Jin-E', 'Initials': 'JE', 'LastName': 'Shin', 'Affiliation': 'PepsiCo R&D, Chicago, IL, USA.'}, {'ForeName': 'Britt M', 'Initials': 'BM', 'LastName': 'Burton-Freeman', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA. iedirisi@iit.edu.'}]",Nutrition & diabetes,['10.1038/s41387-019-0091-z']
956,31439599,Glucocorticoids for acute urticaria: study protocol for a double-blind non-inferiority randomised controlled trial.,"INTRODUCTION


This study protocol describes a trial designed to investigate whether antihistamine alone in patients with acute urticaria does not increase the 7-day Urticaria Activity Score (UAS7) in comparison with an association of antihistamine and glucocorticoids and reduces short-term relapses and chronic-induced urticaria.
METHODS AND ANALYSIS


This is a prospective, double-blind, parallel-group, multicentre non-inferiority randomised controlled trial. Two-hundred and forty patients with acute urticaria admitted to emergency department will be randomised in a 1:1 ratio to receive levocetirizine or an association of levocetirizine and prednisone. Randomisation will be stratified by centre. The primary outcome will be the UAS7 at day 7. The secondary outcomes will encompass recurrence of hives and/or itch at day 7; occurrence of spontaneous hives or itch for >6 weeks; patients with angioedema at day 7, and 2, 6, 12 and 24 weeks; new emergency visits for acute urticaria recurrences at days 7 and 14, and 3 months; Dermatology Life Quality Index at days 7 and 14, and 3 and 6 months; and Chronic Urticaria Quality of Life Questionnaire at 6 weeks.
ETHICS AND DISSEMINATION


The protocol has been approved by the  Comité de Protection des Personnes   Sud-Méditerranée II  and will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A steering committee will oversee the progress of the study. Findings will be disseminated through national and international scientific conferences and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03545464.",2019,"The secondary outcomes will encompass recurrence of hives and/or itch at day 7; occurrence of spontaneous hives or itch for >6 weeks; patients with angioedema at day 7, and 2, 6, 12 and 24 weeks; new emergency visits for acute urticaria recurrences at days 7 and 14, and 3 months; Dermatology Life Quality Index at days 7 and 14, and 3 and 6 months; and Chronic Urticaria Quality of Life Questionnaire at 6 weeks.
","['Two-hundred and forty patients with acute urticaria admitted to emergency department', 'patients with acute urticaria', 'acute urticaria']","['Glucocorticoids', 'antihistamine', 'antihistamine and glucocorticoids', 'levocetirizine and prednisone', 'levocetirizine']","['Chronic Urticaria Quality of Life Questionnaire', '7-day Urticaria Activity Score (UAS7', 'Dermatology Life Quality Index', 'new emergency visits for acute urticaria recurrences', 'recurrence of hives and/or itch at day 7; occurrence of spontaneous hives or itch for >6 weeks; patients with angioedema']","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234935', 'cui_str': 'Acute urticaria (disorder)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0263338', 'cui_str': 'Chronic urticaria (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042109', 'cui_str': 'Hives'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0234935', 'cui_str': 'Acute urticaria (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869027', 'cui_str': 'Angioedema (SMQ)'}]",240.0,0.216427,"The secondary outcomes will encompass recurrence of hives and/or itch at day 7; occurrence of spontaneous hives or itch for >6 weeks; patients with angioedema at day 7, and 2, 6, 12 and 24 weeks; new emergency visits for acute urticaria recurrences at days 7 and 14, and 3 months; Dermatology Life Quality Index at days 7 and 14, and 3 and 6 months; and Chronic Urticaria Quality of Life Questionnaire at 6 weeks.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Javaud', 'Affiliation': 'Emergency Department, Hopital Louis-Mourier, Colombes, France nicolas.javaud@aphp.fr.'}, {'ForeName': 'Angele', 'Initials': 'A', 'LastName': 'Soria', 'Affiliation': 'Dermatology, Hopital Tenon, Paris, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Maignan', 'Affiliation': 'Emergency Department, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Descamps', 'Affiliation': 'Dermatology, Hopital Bichat-Claude-Bernard, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fain', 'Affiliation': 'Internal Medicine, Hopital Saint-Antoine, Paris, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Bouillet', 'Affiliation': 'National Reference Centre for Angioedema, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Berard', 'Affiliation': 'Dermatology, Hospital Édouard Herriot, Lyon, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Tazarourte', 'Affiliation': 'Emergency Medicine, University Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Roy', 'Affiliation': 'Emergency Medicine, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Fontaine', 'Affiliation': 'Emergency, Hopital Saint-Louis, Paris, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Bagot', 'Affiliation': 'Dermatology, Hopital Saint-Louis, Paris, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Khellaf', 'Affiliation': 'Emergency, Hopital Henri Mondor, Creteil, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Goulet', 'Affiliation': 'Emergency, Hopital Tenon, Paris, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'Urgences-SAMU 93-Unité Recherche-Enseignement-Qualité, APHP, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Casalino', 'Affiliation': 'Emergency, Hopital Bichat-Claude-Bernard, Paris, France.'}, {'ForeName': 'Marie-Sylvie', 'Initials': 'MS', 'LastName': 'Doutre', 'Affiliation': 'Dermatology, Centre Hospitalier Universitaire de Bordeaux, Groupe Hospitalier Pellegrin, Bordeaux, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Gil-Jardine', 'Affiliation': 'Emergency, Centre Hospitalier Universitaire de Bordeaux, Groupe Hospitalier Pellegrin, Bordeaux, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Caux', 'Affiliation': 'Dermatology, Hopital Avicenne, Bobigny, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chosidow', 'Affiliation': 'Dermatology, Hopital Henri Mondor, Creteil, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Pateron', 'Affiliation': ""Emergency, AP-HP, Hôpital Saint-Antoine, Service d'Accueil des Urgences, Paris, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Clinical Research Department, Assistance Publique-Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'Urgences-SAMU 93-Unité Recherche-Enseignement-Qualité, APHP, Hôpital Avicenne, Bobigny, France.'}]",BMJ open,['10.1136/bmjopen-2018-027431']
957,31485815,Increasing Access to Developmental Services for Children with Autism Spectrum Disorder: The Pediatric Developmental Passport Pilot Randomized Trial.,"The pediatric developmental passport was created to aid service navigation for children with autism spectrum disorder (ASD). A pilot-randomized-control trial was conducted at two developmental clinics. The intervention group received the Passport card versus the control group who received the placebo card. Primary outcome was the proportion of families who contacted ASD services 1-year following diagnosis. Of 40 families, 95% in the intervention group contacted services versus 70% in the control (p = 0.04). All families at the academic site contacted services; at the community site 90% in the intervention group contacted versus 40% in the control (p = 0.02). The Passport shows promise aiding families of children with ASD in service navigation, particularly at community clinics where specialist follow-up is not readily available.",2019,"Of 40 families, 95% in the intervention group contacted services versus 70% in the control (p = 0.04).","['Spectrum Disorder', 'children with autism spectrum disorder (ASD', 'Children with Autism']",['Passport card versus the control group who received the placebo card'],['proportion of families who contacted ASD services 1-year following diagnosis'],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",40.0,0.0893507,"Of 40 families, 95% in the intervention group contacted services versus 70% in the control (p = 0.04).","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Young', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada. younge@smh.ca.'}, {'ForeName': 'Ramanan', 'Initials': 'R', 'LastName': 'Aiyadurai', 'Affiliation': ""Pediatrics, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Thivia', 'Initials': 'T', 'LastName': 'Jegathesan', 'Affiliation': ""Pediatrics, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bechard', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ripudaman S', 'Initials': 'RS', 'LastName': 'Minhas', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dillon', 'Affiliation': ""Children's Treatment Network of Simcoe York, Richmond Hill, ON, Canada.""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Maguire', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04199-3']
958,31486832,Assessment of Treatment With Sorafenib Plus Doxorubicin vs Sorafenib Alone in Patients With Advanced Hepatocellular Carcinoma: Phase 3 CALGB 80802 Randomized Clinical Trial.,"Importance


Previous communication has reported significant improvement in overall survival (OS) when using doxorubicin plus sorafenib in the treatment of advanced hepatocellular cancer (HCC).
Objective


To determine if doxorubicin added to sorafenib therapy improves OS, with stratification for locally advanced and metastatic disease.
Design, Setting, and Participants


This unblinded randomized phase 3 clinical trial was led by Alliance in collaboration with Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Canadian Cancer Trials Group, and Southwest Oncology Group. It was launched in February 2010 and completed in May 2015; data were also analyzed during this time frame. Patients with histologically proven advanced HCC, no prior systemic therapy, Child-Pugh grade A score, Eastern Cooperative Oncology Group performance status of 0 to 2 (later amended to 0-1), and adequate hematologic, hepatic, renal, and cardiac function were eligible. The OS primary end point had a final analysis planned with 364 events observed among 480 total patients with 90% power to detect a 37% increase in median OS.
Interventions or Exposures


Patients received either 60 mg/m2 of doxorubicin every 21 days plus 400 mg of sorafenib orally twice daily or the sorafenib alone, adjusted to half doses for patients with bilirubin levels of 1.3 to 3.0 mg/dL.
Main Outcomes and Measures


The primary end point was OS, and progression-free survival (PFS) was a secondary end point.
Results


Of 356 patients included in the study, the mean (SD) age was 62 (10.1) years, and 306 (86.0%) were men. Although it was planned to include 480 patients, the study was halted after accrual of 356 patients (180 patients treated with doxorubicin plus sorafenib and 176 with sorafenib alone) with a futility boundary crossed at a planned interim analysis. Median OS was 9.3 months (95% CI, 7.3-10.8 months) in the doxorubicin plus sorafenib arm and 9.4 months (95% CI, 7.3-12.9 months) in the sorafenib alone arm (hazard ratio, 1.05; 95% CI, 0.83-1.31). The median PFS was 4.0 months (95% CI, 3.4-4.9 months) in the doxorubicin plus sorafenib arm and 3.7 months (95% CI, 2.9-4.5 months) in the sorafenib alone arm (hazard ratio, 0.93; 95% CI, 0.75-1.16). Grade 3 or 4 neutropenia and thrombocytopenia adverse events occurred in 61 (36.8%) and 29 (17.5%) patients, respectively, being treated with doxorubicin plus sorafenib vs 1 (0.6%) and 4 (2.4%) patients treated with sorafenib.
Conclusions and Relevance


This multigroup study of the addition of doxorubicin to sorafenib therapy did not show improvement of OS or PFS in patients with HCC.
Trial Registration


ClinicalTrials.gov identifier: NCT01015833.",2019,"Grade 3 or 4 neutropenia and thrombocytopenia adverse events occurred in 61 (36.8%) and 29 (17.5%) patients, respectively, being treated with doxorubicin plus sorafenib vs 1 (0.6%) and 4 (2.4%) patients treated with sorafenib.
","['collaboration with Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Canadian Cancer Trials Group, and Southwest Oncology Group', 'mean (SD) age was 62 (10.1) years, and 306 (86.0%) were men', 'and 176 with sorafenib alone) with a futility boundary crossed at a planned interim analysis', '356 patients included in the study', 'Patients with histologically proven advanced HCC, no prior systemic therapy, Child', '480 patients, the study was halted after accrual of 356 patients (180 patients treated with', 'advanced hepatocellular cancer (HCC', 'patients with HCC', 'Patients With Advanced Hepatocellular Carcinoma']","['60 mg/m2 of doxorubicin', 'sorafenib orally twice daily or the sorafenib alone', 'Sorafenib Plus Doxorubicin vs Sorafenib Alone', 'doxorubicin plus sorafenib', 'doxorubicin', 'sorafenib therapy', 'doxorubicin to sorafenib therapy']","['Grade 3 or 4 neutropenia and thrombocytopenia adverse events', 'OS, and progression-free survival (PFS', 'median PFS', 'median OS', 'OS or PFS', 'overall survival (OS', 'Median OS', 'adequate hematologic, hepatic, renal, and cardiac function']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",480.0,0.121298,"Grade 3 or 4 neutropenia and thrombocytopenia adverse events occurred in 61 (36.8%) and 29 (17.5%) patients, respectively, being treated with doxorubicin plus sorafenib vs 1 (0.6%) and 4 (2.4%) patients treated with sorafenib.
","[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Knox', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kaubisch', 'Affiliation': 'Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Posey', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Tan', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kavan', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Goel', 'Affiliation': 'Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Lammers', 'Affiliation': 'Meharry Medical College, Nashville, Tennessee.'}, {'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Tam', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Rajdev', 'Affiliation': 'Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}, {'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'El Dika', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ryan I', 'Initials': 'RI', 'LastName': 'Potaracke', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Balletti', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Harding', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Suga', 'Affiliation': 'Kaiser Permanente Vallejo Medical Center, Vallejo, California.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2792']
959,30944040,Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study).,"BACKGROUND


Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue currently approved for type 2 diabetes and obesity. Preclinical evidence in transgenic models of Alzheimer's disease suggests that liraglutide exerts neuroprotective effects by reducing amyloid oligomers, normalising synaptic plasticity and cerebral glucose uptake, and increasing the proliferation of neuronal progenitor cells. The primary objective of the study is to evaluate the change in cerebral glucose metabolic rate after 12 months of treatment with liraglutide in participants with Alzheimer's disease compared to those who are receiving placebo.
METHODS/DESIGN


ELAD is a 12-month, multi-centre, randomised, double-blind, placebo-controlled, phase IIb trial of liraglutide in participants with mild Alzheimer's dementia. A total of 206 participants will be randomised to receive either liraglutide or placebo as a daily injection for a year. The primary outcome will be the change in cerebral glucose metabolic rate in the cortical regions (hippocampus, medial temporal lobe, and posterior cingulate) from baseline to follow-up in the treatment group compared with the placebo group. The key secondary outcomes are the change from baseline to 12 months in z scores for clinical and cognitive measures (Alzheimer's Disease Assessment Scale-Cognitive Subscale and Executive domain scores of the Neuropsychological Test Battery, Clinical Dementia Rating Sum of Boxes, and Alzheimer's Disease Cooperative Study-Activities of Daily Living) and the incidence and severity of treatment-emergent adverse events or clinically important changes in safety assessments. Other secondary outcomes are 12-month change in magnetic resonance imaging volume, diffusion tensor imaging parameters, reduction in microglial activation in a subgroup of participants, reduction in tau formation and change in amyloid levels in a subgroup of participants measured by tau and amyloid imaging, and changes in composite scores using support machine vector analysis in the treatment group compared with the placebo group.
DISCUSSION


Alzheimer's disease is a leading cause of morbidity worldwide. As available treatments are only symptomatic, the search for disease-modifying therapies is a priority. If the ELAD trial is successful, liraglutide and GLP-1 analogues will represent an important class of compounds to be further evaluated in clinical trials for Alzheimer's treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01843075 . Registration 30 April 2013.",2019,"Other secondary outcomes are 12-month change in magnetic resonance imaging volume, diffusion tensor imaging parameters, reduction in microglial activation in a subgroup of participants, reduction in tau formation and change in amyloid levels in a subgroup of participants measured by tau and amyloid imaging, and changes in composite scores using support machine vector analysis in the treatment group compared with the placebo group.
","[""participants with mild Alzheimer's dementia"", '206 participants', ""Alzheimer's disease"", ""participants with Alzheimer's disease""]","['liraglutide or placebo', 'novel GLP-1 analogue liraglutide', 'placebo', 'liraglutide']","['tau formation and change in amyloid levels', ""z scores for clinical and cognitive measures (Alzheimer's Disease Assessment Scale-Cognitive Subscale and Executive domain scores of the Neuropsychological Test Battery, Clinical Dementia Rating Sum of Boxes, and Alzheimer's Disease Cooperative Study-Activities of Daily Living) and the incidence and severity of treatment-emergent adverse events or clinically important changes in safety assessments"", 'change in cerebral glucose metabolic rate in the cortical regions (hippocampus, medial temporal lobe, and posterior cingulate', 'cerebral glucose metabolic rate', 'magnetic resonance imaging volume, diffusion tensor imaging parameters, reduction in microglial activation']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",206.0,0.670611,"Other secondary outcomes are 12-month change in magnetic resonance imaging volume, diffusion tensor imaging parameters, reduction in microglial activation in a subgroup of participants, reduction in tau formation and change in amyloid levels in a subgroup of participants measured by tau and amyloid imaging, and changes in composite scores using support machine vector analysis in the treatment group compared with the placebo group.
","[{'ForeName': 'Grazia Daniela', 'Initials': 'GD', 'LastName': 'Femminella', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangou', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Busza', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Holmes', 'Affiliation': 'Southern Health NHS Foundation Trust, Havant, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ritchie', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lawrence', 'Affiliation': ""SW London and St George's Mental Health Trust, London , UK.""}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'McFarlane', 'Affiliation': 'Southern Health NHS Foundation Trust, Havant, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tadros', 'Affiliation': 'Aston Medical school, Aston University, Birmingham, UK.'}, {'ForeName': 'Basil H', 'Initials': 'BH', 'LastName': 'Ridha', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bannister', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Walker', 'Affiliation': 'University College London and Essex Partnership University NHS Foundation Trust, Runwell, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Archer', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coulthard', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Underwood', 'Affiliation': 'Cambridgeshire and Peterborough NHS Foundation Trust, Peterborough, UK.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Prasanna', 'Affiliation': 'Black Country Partnership NHS Foundation Trust, West Bromwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Koranteng', 'Affiliation': 'Northamptonshire Healthcare NHS Foundation Trust, Kettering, UK.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Karim', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Kehinde', 'Initials': 'K', 'LastName': 'Junaid', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'McGuinness', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nilforooshan', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, Leatherhead, UK.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Macharouthu', 'Affiliation': 'NHS Ayrshire and Arran, Crosshouse, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Donaldson', 'Affiliation': 'NHS Lanarkshire, Glasgow, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thacker', 'Affiliation': 'Derbyshire Healthcare NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Bradford District Care NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Naghma', 'Initials': 'N', 'LastName': 'Malik', 'Affiliation': '5 Boroughs Partnership NHS Foundation Trust, Warrington, UK.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Mate', 'Affiliation': 'Cornwall Partnership NHS Foundation Trust, Redruth, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Knight', 'Affiliation': 'Somerset Partnership NHS Foundation Trust, Bridgwater, UK.'}, {'ForeName': 'Sajeev', 'Initials': 'S', 'LastName': 'Kshemendran', 'Affiliation': 'South Staffordshire and Shropshire Healthcare NHS Foundation Trust, Stafford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Harrison', 'Affiliation': 'Alzheimer Center VUmc Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hölscher', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Brooks', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Anthony Peter', 'Initials': 'AP', 'LastName': 'Passmore', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Edison', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK. paul.edison@imperial.ac.uk.'}]",Trials,['10.1186/s13063-019-3259-x']
960,31266825,A Randomized Controlled Trial Testing Provision of Fecal and Blood Test Options on Participation for Colorectal Cancer Screening.,"Suboptimal participation is commonly observed in colorectal cancer screening programs utilizing fecal tests. This randomized controlled trial tested whether the offer of a blood test as either a ""rescue"" strategy for fecal test nonparticipants or an upfront choice, could improve participation. A total of 1,800 people (50-74 years) were randomized to control, rescue, or choice groups ( n  = 600/group). All were mailed a fecal immunochemical test (FIT, OC-Sensor, Eiken Chemical Company) and a survey assessing awareness of the screening tests. The rescue group was offered a blood test 12 weeks after FIT nonparticipation. The choice group was given the opportunity to choose to do a blood test (Colvera, Clinical Genomics) instead of FIT at baseline. Participation with any test after 24 weeks was not significantly different between groups (control, 37.8%; rescue, 36.9%; choice, 33.8%;  P  > 0.05). When the rescue strategy was offered after 12 weeks, an additional 6.5% participated with the blood test, which was greater than the blood test participation when offered as an upfront choice (1.5%;  P  < 0.001). Awareness of the tests was greater for FIT than for blood (96.2% vs. 23.1%;  P  < 0.0001). In a population familiar with FIT screening, provision of a blood test either as a rescue of FIT nonparticipants or as an upfront choice did not increase overall participation. This might reflect a lack of awareness of the blood test for screening compared with FIT.",2019,"Awareness of the tests was greater for FIT than for blood (96.2% vs 23.1%, p<0.0001).","['colorectal cancer screening', '1800 people (50-74y']",['fecal and blood test options'],"['fecal immunochemical test (FIT, OC-Sensor, Eiken Chemical Company']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0018941', 'cui_str': 'Blood Tests'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}]",,0.173561,"Awareness of the tests was greater for FIT than for blood (96.2% vs 23.1%, p<0.0001).","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Symonds', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia. Erin.Symonds@sa.gov.au.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Flight', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, School of Medicine, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Centre for Health Economics, Monash University, Caulfield East, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'College of Nursing and Health Sciences, Health and Social Care Economics Group, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Genomics Pty Ltd, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Robert J L', 'Initials': 'RJL', 'LastName': 'Fraser', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Carlene J', 'Initials': 'CJ', 'LastName': 'Wilson', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Graeme P', 'Initials': 'GP', 'LastName': 'Young', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0089']
961,31462579,Communicating about chemicals in cigarette smoke: impact on knowledge and misunderstanding.,"BACKGROUND


The USA must publicly share information about harmful and potentially harmful constituents (chemicals) in tobacco products. We sought to understand whether webpages with chemical information are ""understandable and not misleading to a lay person.""
METHODS


Participants were a national probability sample of US adults and adolescents ( n =1441, 18% smokers). In an online experiment, we randomly assigned participants to view one of the developed webpages (chemical names only, names with quantity ranges, names with visual risk indicators) or no webpage in phase one (between subjects). Participants completed a survey assessing knowledge, misunderstanding, perceived likelihood, perceived severity of health effects from smoking and quit intentions (smokers only). In phase two (within subjects), participants viewed all three webpage formats and reported webpage perceptions (clarity, usability, usefulness) and perceived impact (affect, elaboration, perceived effectiveness).
RESULTS


In phase one, viewing any webpage led to more knowledge of chemicals (48%-54% vs 28% no webpage,  p s<0.001) and health harms (77% vs 67% no webpage,  p s<0.001). When exposed to any webpage, 5%-23% endorsed misunderstandings that some cigarettes are safer than others. Webpage format did not affect knowledge or reduce misunderstandings. Viewing any webpage led to higher perceived likelihood of experiencing health effects from smoking ( p< 0.001) and, among smokers, greater intentions to quit smoking ( p =0.04). In phase two, where participants viewed all formats, a visual risk indicator led to the highest perceived impact.
CONCLUSIONS


Knowledge of chemicals and health effects can increase after viewing a website. Yet, websites may not correct the misunderstanding that some cigarettes are safer.",2020,"Viewing any webpage led to higher perceived likelihood of experiencing health effects from smoking ( p   < 0.001) and, among smokers, greater intentions to quit smoking ( p =0.04).","['Participants were a national probability sample of US adults and adolescents ( n =1441, 18% smokers', 'cigarette smoke']","['webpages (chemical names only, names with quantity ranges, names with visual risk indicators) or no webpage in phase one']","['knowledge of chemicals', 'health harms', 'webpage perceptions (clarity, usability, usefulness) and perceived impact (affect, elaboration, perceived effectiveness', 'intentions to quit smoking']","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0033206', 'cui_str': 'Probability Sample'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0532091,"Viewing any webpage led to higher perceived likelihood of experiencing health effects from smoking ( p   < 0.001) and, among smokers, greater intentions to quit smoking ( p =0.04).","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'M Justin', 'Initials': 'MJ', 'LastName': 'Byron', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': 'Psychology, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA ntb@unc.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054863']
962,11455733,Perioperative treatment with bactericidal/permeability-increasing protein (rBPI21) in major liver surgery: a concise summary.,"INTRODUCTION


Major hepatic resections are still associated with considerable morbidity. Gut-derived bacteria and bacterial endotoxin are considered to play a central role in the pathophysiology of complications. Experimental studies suggest that bactericidal/permeability-increasing protein (BPI), which has both antibacterial and endotoxin-neutralising properties, can reduce postoperative complications.
MATERIAL AND METHODS


A phase II, double-blind, placebo-controlled, multicentre, dose escalation trial was conducted in patients undergoing major liver resection, and clinical outcome, infectious complications, plasma amino acid patterns, coagulation and fibrinolytic cascade systems and neutrophil functions were compared between the two treatment groups and an extra group of patients undergoing major abdominal non-hepatic surgery.
RESULTS


Drug administration in this patient group was safe, and resulted in a significant reduction of infectious complications. Furthermore, beneficial effects were found in the postoperative amino acid ratio and fibrinolytic cascades, and rBPI21 preserved leukocyte functions.
CONCLUSION


Administration of rBPI21 in patients undergoing major liver resection is well tolerated and results in improvement of both clinical and biochemical parameters.",2001,"Furthermore, beneficial effects were found in the postoperative amino acid ratio and fibrinolytic cascades, and rBPI21 preserved leukocyte functions.
","['patients undergoing major liver resection, and clinical outcome, infectious complications, plasma amino acid patterns, coagulation and fibrinolytic cascade systems and neutrophil functions were compared between the two treatment groups and an extra group of patients undergoing major abdominal non-hepatic surgery', 'patients undergoing major liver resection', 'major liver surgery']","['rBPI21', 'bactericidal/permeability-increasing protein (rBPI21', 'placebo']","['infectious complications', 'postoperative amino acid ratio and fibrinolytic cascades, and rBPI21 preserved leukocyte functions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023884', 'cui_str': 'Liver'}]","[{'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0707583,"Furthermore, beneficial effects were found in the postoperative amino acid ratio and fibrinolytic cascades, and rBPI21 preserved leukocyte functions.
","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Wiezer', 'Affiliation': 'Department of Surgery, Vrije Universiteit Medical Centre, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Boelens', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Vuylsteke', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Nijveldt', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meijer', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Meijer', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'van Leeuwen', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
963,11455735,Effect of different endotracheal suctioning systems on cardiorespiratory parameters of ventilated patients.,"INTRODUCTION


We conducted this prospective randomised cross-over study to evaluate the effect of closed system (CS) versus open system (OS) endotracheal suctioning on heart rate (HR), mean arterial pressure (MAP), respiratory rate (RR), oxygen saturation (SpO2) and electrocardiogram (ECG) rhythm of patients on mechanical ventilation.
MATERIALS AND METHODS


Fourteen adult patients were randomly allocated to receive either CS or OS suctioning in the first instance. For the subsequent suctioning, they were crossed over to the alternate suctioning system. The various cardiorespiratory parameters were recorded at BL1 (baseline 1), S1 (first suction pass), BL2 (baseline 2, i.e. immediately post first suction pass), S2 (second suction pass), T2 (2 minutes post suction) and T5 (5 minutes post suction).
RESULTS


Compared to CS, OS suctioning was found to result in higher HR at S1 (P < or = 0.05) and S2 (P < or = 0.05); higher MAP at BL2 (P < or = 0.05); lower SpO2 at BL2 (P < or = 0.01) and S2 (P < or = 0.01). There was no significant difference in RR between the two suctioning systems. OS suctioning was also noted to result in a significantly higher incidence of arrhythmia (P < = or 0.05).
CONCLUSION


Our study shows that OS suctioning results in more adverse changes in cardiorespiratory parameters compared to CS suctioning.",2001,"OS suctioning was also noted to result in a significantly higher incidence of arrhythmia (P < = or 0.05).
","['ventilated patients', 'Fourteen adult patients']","['CS or OS suctioning', 'closed system (CS) versus open system (OS) endotracheal suctioning', 'OS suctioning', 'endotracheal suctioning systems']","['arrhythmia', 'cardiorespiratory parameters', 'heart rate (HR), mean arterial pressure (MAP), respiratory rate (RR), oxygen saturation (SpO2) and electrocardiogram (ECG) rhythm of patients on mechanical ventilation', 'RR', 'SpO2 at BL2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0450596', 'cui_str': 'BL2 (body structure)'}]",14.0,0.0179104,"OS suctioning was also noted to result in a significantly higher incidence of arrhythmia (P < = or 0.05).
","[{'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, Coronary Intensive Care Unit (Ward 6A), Tan Tock Seng Hospital, Singapore 308433.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ang', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
964,32433914,Randomized trial comparing fork-tip and side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic lesions.,"BACKGROUND AND AIMS


The aim of this study was to compare the performance of EUS-guided fine-needle biopsy using fork-tip or side-fenestrated needles in patients with solid pancreatic lesions.
METHODS


A randomized controlled study was conducted in a single academic center on patients who underwent sampling with fork-tip or side-fenestrated 22-gauge or 25-gauge needles. Three passes were performed, each independently evaluated by a blinded pathologist and by endosonographers for macroscopic on-site evaluation (MOSE). The primary outcome was histologic yield; secondary aims were safety, diagnostic yield, sample quality, number of needle passes required to establish a diagnosis, and reliability of MOSE.
RESULTS


One hundred ninety-two patients were enrolled. Both 22-gauge and 25-gauge fork-tip needles retrieved significantly higher rates of histologic samples than side-fenestrated needles (P < .013). Safety and diagnostic accuracy were comparable in the 2 arms, whereas sample quality (tissue integrity and blood contamination) was significantly better in the fork-tip group (P < .0001). The median number of diagnostic passes was lower using fork-tip needles (P = .054). The agreement between MOSE and pathologic evaluation was almost perfect in the fork-tip group and fair in the side-fenestrated group.
CONCLUSIONS


Both needles showed equivalent safety and diagnostic accuracy. However, fork-tip needles provided a higher rate of extremely good-quality histologic samples and required fewer needle passes to reach a diagnosis. MOSE is a highly reliable tool when fork-tip needles are used compared with side-fenestrated needles. (Clinical trial registration number: NCT03622229.).",2020,MOSE is a highly reliable tool when fork-tip needles are used as compared with side-fenestrated needles.,"['patients who underwent sampling with the fork-tip or the', 'One hundred ninety-two patients were enrolled', 'patients with solid pancreatic lesions']","['EUS-guided fine-needle biopsy using fork-tip (SharkCore, Medtronic, USA) or side-fenestrated (ProCore, Cook Medical, Limerick, Ireland) needles', 'fork-tip and the side-fenestrated needles for EUS-guided fine-needle biopsy', 'MOSE', 'side-fenestrated 22-gauge or 25-gauge needles']","['Safety and diagnostic accuracy', 'histological yield', 'MOSE and pathological evaluation', 'safety, diagnostic yield, sample quality, number of needle passes required to establish a diagnosis, and reliability of MOSE', 'equivalent safety and diagnostic accuracy', 'rates of histological samples', 'Median number of diagnostic passes', 'sample quality (tissue integrity and blood contamination']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0454785', 'cui_str': 'Limerick'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0456638', 'cui_str': '25G'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",192.0,0.0357894,MOSE is a highly reliable tool when fork-tip needles are used as compared with side-fenestrated needles.,"[{'ForeName': 'Stefano Francesco', 'Initials': 'SF', 'LastName': 'Crinò', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Le Grazie', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Erminia', 'Initials': 'E', 'LastName': 'Manfrin', 'Affiliation': 'Unit of Pathology, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Conti Bellocchi', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bernardoni', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Granato', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Unit of Epidemiology and Medical Statistics, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parisi', 'Affiliation': 'Unit of Pathology, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Stefano', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Frulloni', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Larghi', 'Affiliation': 'Digestive Endoscopy Unit, Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Gabbrielli', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.016']
965,1309115,The spontaneous LH surge in ovarian hyperstimulation for assisted reproductive technology.,"Thirty-seven patients who underwent assisted reproductive technology programme, in vitro fertilisation or embryo transfer and gamete intra-fallopian transfer, were randomised into two groups in order to evaluate frequency of premature spontaneous LH surge when stimulated with different type of hMG. An hMG (FSH:LH = 1:1) was administered for eighteen patients (group A) and the different highly purified hMG (FSH:LH = 19:1) was administered for nineteen patients (group B). Blood samples are drawn from day 3 of the cycle until hCG administration, and serum LH level are measured in the frozen samples. There were no statistical difference in the total amount of hMG used before hCG injection, days of hMG injection and the number of oocytes retrieved between two groups. The premature spontaneous LH surge occurred only one patient in group A (5.6%), but more frequent LH surge was observed in group B (42.1%) (p < 0.05). It is suggested that the different FSH/LH ratio may be the reason for the difference of the incidence of premature spontaneous LH surge.",1992,"There were no statistical difference in the total amount of hMG used before hCG injection, days of hMG injection and the number of oocytes retrieved between two groups.","['Thirty-seven patients who underwent assisted reproductive technology programme, in vitro fertilisation or embryo transfer and gamete intra-fallopian transfer']",[],"['frequent LH surge', 'number of oocytes', 'premature spontaneous LH surge', 'total amount of hMG', 'serum LH level']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C2718310', 'cui_str': 'Gametes'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",[],"[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C1304771', 'cui_str': 'Serum LH measurement'}]",,0.0508798,"There were no statistical difference in the total amount of hMG used before hCG injection, days of hMG injection and the number of oocytes retrieved between two groups.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hoshiai', 'Affiliation': 'Department of Obstetrics and Gynaecology Kinki University School of Medicine, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ohi', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
966,11957554,Four-month chemotherapy in the treatment of smear-negative pulmonary tuberculosis: results at 30 to 60 months.,"INTRODUCTION


Most patients with active pulmonary tuberculosis (PTB) are treated with a 6-month short course regimen. The purpose of the present study was to assess the efficacy of using 4 months of chemotherapy to treat patients with smear-negative PTB.
METHODS


A total of 314 patients were randomised to a daily or combined (daily and intermittent) regimen as follows: (1) 2HRZ/2HR--2 months of isoniazid (H), rifampicin (R) and pyrazinamide (Z), followed by 2 months of H and R or (2) 2HRZ/2H3R3--2 months of HRZ as in regimen 1, followed by H and R given 3 times weekly for 2 months or 4 months if initial sputum specimens were culture positive.
RESULTS


One hundred and fifty-eight patients were assigned to the daily regimen and 156 to the combined regimen. Of the 158 patients, 99 had negative cultures and 59 had positive cultures. There was no relapse among 96 culture-negative patients assessed at 30 months and 68 patients at 60 months. However, 6 patients had no radiological response while 1 was considered on review to have non-tuberculous disease. There was no relapse among 57 culture-positive patients assessed at 30 months and 41 at 60 months. In the combined regimen group, 102 had negative cultures and 54 had positive cultures. There was 1 relapse in the culture-negative group of 100 patients assessed at 30 months and 74 at 60 months. There was no radiological response in 5 patients. One patient in the culture-positive group failed therapy but there were no relapses during follow-up to 60 months.
CONCLUSION


A 4-month daily or combined regimen appears to be highly effective in the treatment of non-immunocompromised patients with smear- and culture-negative PTB.",2002,"One patient in the culture-positive group failed therapy but there were no relapses during follow-up to 60 months.
","['patients with smear-negative PTB', 'patients with active pulmonary tuberculosis (PTB', 'non-immunocompromised patients with smear- and culture-negative PTB', 'One hundred and fifty-eight patients', '314 patients', '158 patients, 99 had negative cultures and 59 had positive cultures', 'smear-negative pulmonary tuberculosis']","['isoniazid (H), rifampicin (R) and pyrazinamide (Z), followed by 2 months of H and R or (2) 2HRZ/2H3R3--2 months of HRZ', 'chemotherapy']",['radiological response'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],314.0,0.0313463,"One patient in the culture-positive group failed therapy but there were no relapses during follow-up to 60 months.
","[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Teo', 'Affiliation': 'Department of Medicine, Alexandra Hospital, 378 Alexandra Road, Singapore 159964.'}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Khoo', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
967,31455700,Proactive community case management and child survival: protocol for a cluster randomised controlled trial.,"INTRODUCTION


Community health workers (CHWs)-shown to improve access to care and reduce maternal, newborn, and child morbidity and mortality-are re-emerging as a key strategy to achieve health-related Sustainable Development Goals (SDGs). However, recent evaluations of national programmes for CHW-led integrated community case management (iCCM) of common childhood illnesses have not found benefits on access to care and child mortality. Developing innovative ways to maximise the potential benefits of iCCM is critical to achieving the SDGs.
METHODS AND ANALYSIS


An unblinded, cluster randomised controlled trial in rural Mali aims to test the efficacy of the addition of door-to-door proactive case detection by CHWs compared with a conventional approach to iCCM service delivery in reducing under-five mortality. In the intervention arm, 69 village clusters will have CHWs who conduct daily proactive case-finding home visits and deliver doorstep counsel, care, referral and follow-up. In the control arm, 68 village clusters will have CHWs who provide the same services exclusively out of a fixed community health site. A baseline population census will be conducted of all people living in the study area. All women of reproductive age will be enrolled in the study and surveyed at baseline, 12, 24 and 36 months. The survey includes a life table tracking all live births and deaths occurring prior to enrolment through the 36 months of follow-up in order to measure the primary endpoint: under-five mortality, measured as deaths among children under 5 years of age per 1000 person-years at risk of mortality.
ETHICS AND DISSEMINATION


The trial has received ethical approval from the Ethics Committee of the Faculty of Medicine, Pharmacy and Dentistry, University of Bamako. The results will be disseminated through peer-reviewed publications, national and international conferences and workshops, and media outlets.
TRIAL REGISTRATION NUMBER


NCT02694055; Pre-results.",2019,"An unblinded, cluster randomised controlled trial in rural Mali aims to test the efficacy of the addition of door-to-door proactive case detection by CHWs compared with a conventional approach to iCCM service delivery in reducing under-five mortality.","['68 village clusters will have CHWs who provide the same services exclusively out of a fixed community health site', 'All women of reproductive age will be enrolled in the study and surveyed at baseline, 12, 24 and 36 months', 'children under 5\u2009years of age per 1000 person-years at risk of mortality']",[],[],"[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",[],[],,0.162774,"An unblinded, cluster randomised controlled trial in rural Mali aims to test the efficacy of the addition of door-to-door proactive case detection by CHWs compared with a conventional approach to iCCM service delivery in reducing under-five mortality.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Whidden', 'Affiliation': 'Research, Monitoring & Evaluation, Muso, Bamako, Mali.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Treleaven', 'Affiliation': 'Population Studies Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Social and Behavioral Sciences, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': 'School of Public Health, University of California, Berkeley, San Francisco, California, USA.'}, {'ForeName': 'Belco', 'Initials': 'B', 'LastName': 'Poudiougou', 'Affiliation': 'Research, Monitoring & Evaluation, Muso, Bamako, Mali.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bautista-Arredondo', 'Affiliation': 'Division of Health Economics and Health Systems Innovations, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Fay', 'Affiliation': 'Biostatistics Research Branch, National Institutes of Allergy and Infectious Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'Salif', 'Initials': 'S', 'LastName': 'Samaké', 'Affiliation': 'Ministry of Health & Social Affairs, Bamako, Mali.'}, {'ForeName': 'Amadou B', 'Initials': 'AB', 'LastName': 'Cissé', 'Affiliation': 'Program, Muso, Bamako & Bankass, Mali.'}, {'ForeName': 'Djoumé', 'Initials': 'D', 'LastName': 'Diakité', 'Affiliation': 'Program, Muso, Bamako & Bankass, Mali.'}, {'ForeName': 'Youssouf', 'Initials': 'Y', 'LastName': 'Keita', 'Affiliation': 'Innovation & Learning, Muso, Bamako, Mali.'}, {'ForeName': 'Ari D', 'Initials': 'AD', 'LastName': 'Johnson', 'Affiliation': 'Research, Monitoring & Evaluation, Muso, Bamako, Mali.'}, {'ForeName': 'Kassoum', 'Initials': 'K', 'LastName': 'Kayentao', 'Affiliation': 'Research, Monitoring & Evaluation, Muso, Bamako, Mali.'}]",BMJ open,['10.1136/bmjopen-2018-027487']
968,11603137,Intravenous regional anaesthesia using lignocaine and tramadol.,"INTRODUCTION


This prospective, randomised, double-blind study was designed to assess if the addition of 50 mg tramadol to 30 mL 0.5% lignocaine would improve the efficacy of intravenous regional anaesthesia.
MATERIALS AND METHODS


Fifty-four adult patients undergoing upper limb surgery were randomly allocated to receive either 30 mL 0.5% lignocaine and 1 mL normal saline (group A) or 30 mL 0.5% lignocaine and 50 mg tramadol (group B). They were then assessed for onset of sensory and motor block and the VbAS score for tourniquet pain.
RESULTS


Although more patients in group B had a faster onset of sensory and motor block, this was not significantly different. Patients in group B had a significantly lower VbAS score 30 min after tourniquet inflation and after change over to the distal tourniquet (P < 0.05). There were no complaints of postoperative nausea and vomiting. Two patients in group B developed localised skin urticaria of the forearm which resolved with the release of the tourniquet.
CONCLUSION


There is a positive trend that tramadol might improve the quality of intravenous regional anaesthesia.",2001,Patients in group B had a significantly lower VbAS score 30 min after tourniquet inflation and after change over to the distal tourniquet (P < 0.05).,['Fifty-four adult patients undergoing upper limb surgery'],"['lignocaine and tramadol', 'tramadol', '30 mL 0.5% lignocaine and 1 mL normal saline (group A) or 30 mL 0.5% lignocaine and 50 mg tramadol', 'tramadol to 30 mL 0.5% lignocaine']","['postoperative nausea and vomiting', 'faster onset of sensory and motor block', 'quality of intravenous regional anaesthesia', 'VbAS score', 'localised skin urticaria']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0042109', 'cui_str': 'Hives'}]",54.0,0.302611,Patients in group B had a significantly lower VbAS score 30 min after tourniquet inflation and after change over to the distal tourniquet (P < 0.05).,"[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tan', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, 2 Simei Street 3, Singapore 529889.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Pay', 'Affiliation': ''}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
969,11056773,Prophylactic esmolol infusion for the control of cardiovascular responses to extubation after intracranial surgery.,"INTRODUCTION


Emergence from general anaesthesia and extubation are often accompanied by significant surges in heart rate and blood pressure. To document these changes and the efficacy of low-dose beta-blocker infusions in ameliorating these rises, we undertook a descriptive dose-ranging study comparing the use of esmolol to placebo in patients emerging from neuro-anaesthesia.
MATERIALS AND METHODS


Thirty-six patients undergoing intracranial surgery were randomised to receive saline, esmolol 100 micrograms/kg/min or 200 micrograms/kg/min infusions. The number of patients developing severe hypertension or tachycardia in each group was compared using Fisher's exact test.
RESULTS


Systolic blood pressure (SBP) and heart rate (HR) increased in all 3 groups during emergence and peaked at extubation. The proportion of patients with severe tachycardia or hypertension was reduced from 92% in the placebo group to 40% (P = 0.02) and 8% (P = 0.001) in the low and intermediate dose esmolol groups, respectively. Results were better in the intermediate dose group but the difference was not statistically significant. Two patients from the esmolol infusion groups required supplemental medication for bradycardia.
CONCLUSION


Severe hypertension or tachycardia occurs in 92% of patients during extubation following neuro-anaesthesia and warrants the consideration of routine prophylaxis. Prophylactic esmolol infusion for the control of haemodynamic disturbances during extubation is feasible and safe. A modest level of obtundation is evident at 100 micrograms/kg/min but a rate of 200 micrograms/kg/min may prove to be more effective.",2000,"The proportion of patients with severe tachycardia or hypertension was reduced from 92% in the placebo group to 40% (P = 0.02) and 8% (P = 0.001) in the low and intermediate dose esmolol groups, respectively.","['extubation after intracranial surgery', 'Thirty-six patients undergoing intracranial surgery', 'patients emerging from neuro-anaesthesia']","['esmolol', 'placebo', 'esmolol to placebo', 'saline, esmolol 100 micrograms/kg/min or 200 micrograms/kg/min infusions', 'Prophylactic esmolol']","['severe hypertension or tachycardia', 'heart rate and blood pressure', 'proportion of patients with severe tachycardia or hypertension', 'Systolic blood pressure (SBP) and heart rate (HR', 'Severe hypertension or tachycardia']","[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",36.0,0.0894225,"The proportion of patients with severe tachycardia or hypertension was reduced from 92% in the placebo group to 40% (P = 0.02) and 8% (P = 0.001) in the low and intermediate dose esmolol groups, respectively.","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Lim', 'Affiliation': 'Department of Anaesthesiology, Tan Tock Seng Hospital, Singapore. Siew_Hoon_Lim@notes.ttsh.gov.sg'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Tai', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Lin', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
970,31462735,MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.,"We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.",2020,patients receiving Benda alone (p = 0.0029).,"['rituximab-refractory follicular lymphoma (FL', 'Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement']","['obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone', 'bendamustine']","['MRD response', 'progression-free survival', 'overall survival']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0473059,patients receiving Benda alone (p = 0.0029).,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Hospital of the Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Kehden', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harbron', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mundt', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wassner-Fritsch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}]",Leukemia,['10.1038/s41375-019-0559-9']
971,12587093,Accumulation of mitochondrial DNA mutations in human immunodeficiency virus-infected patients treated with nucleoside-analogue reverse-transcriptase inhibitors.,"Nucleoside reverse-transcriptase inhibitor (NRTI) therapy for human immunodeficiency virus (HIV) infection has been associated with mitochondrial DNA (mtDNA) polymerase-gamma inhibition and subsequent mtDNA depletion. Effects on mtDNA mutation, although suggested by critical involvement of polymerase-gamma in DNA-repair reactions, are unknown. In the present study, we assessed the nature and frequency of mitochondrial genome sequence differences in peripheral-blood samples taken prior to NRTI therapy and after 6-77 mo of treatment in 16 NRTI-treated patients. Samples from 10 HIV-infected, treatment-naive control individuals were taken at similar time intervals. Single-stranded conformation polymorphism (SSCP) and DNA-sequencing analysis techniques were used to detect mitochondrial genome sequence variants between paired longitudinal samples, and heteroplasmic populations were quantified after cloning and repeat SSCP/sequencing. Of 16 individuals treated with NRTIs, 5 exhibited altered SSCP profiles associated with the development of novel heteroplasmic DNA sequence changes, whereas no SSCP pattern change within these regions was observed in the control individuals. Heteroplasmic sequence changes were distributed across four regions of the genome: the noncoding region to 12S ribosomal RNA, reduced-nicotinamide-adenine-dinucleotide dehydrogenase 1, and cytochrome oxidase subunits I and III. Of the total of 26 patients who were examined in the present study, 4 of 5 patients with detectable mtDNA sequence changes since commencement of therapy developed evidence of peripheral fat wasting (lipoatrophy) between sample intervals (P=.031). One patient, without detectable sequence changes on NRTI therapy, also developed lipoatrophy. Levels of mtDNA copies/cell in blood samples were determined by quantitative PCR for 11 of the 16 NRTI-exposed patients; 7 of these 11 patients showed reduced levels of mtDNA in blood after therapy, including all 3 patients tested with evidence of mtDNA sequence changes on therapy. These data indicate that NRTI therapy provides conditions permissive for the development of peripheral-blood mtDNA mutations in vivo.",2003,"Levels of mtDNA copies/cell in blood samples were determined by quantitative PCR for 11 of the 16 NRTI-exposed patients; 7 of these 11 patients showed reduced levels of mtDNA in blood after therapy, including all 3 patients tested with evidence of mtDNA sequence changes on therapy.","['16 NRTI-treated patients', 'human immunodeficiency virus-infected patients treated with', 'human immunodeficiency virus (HIV) infection', '26 patients who were examined in the present study, 4 of 5 patients with detectable mtDNA sequence changes since commencement of therapy developed evidence of peripheral fat wasting (lipoatrophy) between sample intervals (P=.031']","['NRTI therapy', 'nucleoside-analogue reverse-transcriptase inhibitors', 'Nucleoside reverse-transcriptase inhibitor (NRTI) therapy']","['Levels of mtDNA copies/cell in blood samples', 'SSCP pattern change']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0012929', 'cui_str': 'mtDNA'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside Analogs'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012929', 'cui_str': 'mtDNA'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0243031', 'cui_str': 'SSCP'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",26.0,0.0218073,"Levels of mtDNA copies/cell in blood samples were determined by quantitative PCR for 11 of the 16 NRTI-exposed patients; 7 of these 11 patients showed reduced levels of mtDNA in blood after therapy, including all 3 patients tested with evidence of mtDNA sequence changes on therapy.","[{'ForeName': 'Annalise M', 'Initials': 'AM', 'LastName': 'Martin', 'Affiliation': 'Centre for Clinical Immunology and Biomedical Statistics, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hammond', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nolan', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Pace', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Den Boer', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Olga Patricia', 'Initials': 'OP', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Christiansen', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mallal', 'Affiliation': ''}]",American journal of human genetics,[]
972,32439340,"Plasma kinetics of mature PCSK9, furin-cleaved PCSK9, and Lp(a) with or without administration of PCSK9 inhibitors in acute myocardial infarction.","BACKGROUND


There are two types of circulating proprotein convertase subtilisin/kexin type 9 (PCSK9), mature and furin-cleaved. Most types of lipoprotein(a) [Lp(a)], an independent risk factor of cardiovascular events, bind to mature PCSK9.
OBJECTIVE


This study examined the effects of monoclonal anti-PCSK9 antibody on plasma PCSK9 and Lp(a) levels in acute myocardial infarction (MI).
METHODS


Acute MI patients (n=36) were randomly divided into evolocumab (140mg; n=17) and non-evolocumab (n=19) groups. Changes in plasma PCSK9 and Lp(a) levels were monitored before and 1, 3, 5, 10, and 20 days after evolocumab administration.
RESULTS


In the non-evolocumab group, plasma levels of mature PCSK9, furin-cleaved PCSK9, and Lp(a) (236.4±57.3ng/mL, 22.4±5.8ng/mL, and 19.2.±16.5mg/dL, respectively) significantly increased by day 3 (408.8±77.1ng/mL, p<0.001; 47.2±15.7ng/mL, p<0.001; and 39.7±21.3mg/dL, p<0.005, respectively) and returned to the baseline by day 10 or 20. In the evolocumab group, mature PCSK9 significantly increased by >1000ng/mL with a simultaneous decline of furin-cleaved PCSK9 below the measurement sensitivity level after day 3. The incremental area under the curve for plasma Lp(a) levels was significantly smaller in the evolocumab group compared with the non-evolocumab group (p=0.038).
CONCLUSION


Mature and furin-cleaved PCSK9 are transiently upregulated after MI onset. Evolocumab significantly increases mature PCSK9 and decreases furin-cleaved PCSK9 and might inhibit transient increase of plasma Lp(a) in acute MI.",2020,"The incremental area under the curve for plasma Lp(a) levels was significantly smaller in the evolocumab group compared with the non-evolocumab group (p=0.038).
","['Acute MI patients (n=36', 'acute myocardial infarction (MI']","['monoclonal anti-PCSK9 antibody', 'evolocumab', 'non-evolocumab', 'lipoprotein(a) [Lp(a', 'PCSK9 inhibitors', 'Mature and furin']","['plasma levels of mature PCSK9, furin-cleaved PCSK9, and Lp(a', 'mature PCSK9 and decreases furin-cleaved PCSK9', 'plasma PCSK9 and Lp(a) levels', 'incremental area under the curve for plasma Lp(a) levels', 'plasma Lp(a', 'mature PCSK9']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C4522007', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0369091,"The incremental area under the curve for plasma Lp(a) levels was significantly smaller in the evolocumab group compared with the non-evolocumab group (p=0.038).
","[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan. Electronic address: AkihiroNakamura0223@msn.com.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kanazawa', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Kagaya', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Masateru', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Endo', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nozaki', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.04.006']
973,31462766,Reward related ventral striatal activity and differential response to sertraline versus placebo in depressed individuals.,"Medications to treat major depressive disorder (MDD) are not equally effective across patients. Given that neural response to rewards is altered in MDD and given that reward-related circuitry is modulated by dopamine and serotonin, we examined, for the first time, whether reward-related neural activity moderated response to sertraline, an antidepressant medication that targets these neurotransmitters. A total of 222 unmedicated adults with MDD randomized to receive sertraline (n = 110) or placebo (n = 112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task. We tested whether an index of reward system function in the ventral striatum (VS), a key reward circuitry region, moderated differential response to sertraline versus placebo, assessed with the Hamilton Rating Scale for Depression (HSRD) over 8 weeks. We observed a significant moderation effect of the reward index, reflecting the temporal dynamics of VS activity, on week-8 depression levels (Fs ≥ 9.67, ps ≤ 0.002). Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms. Thus, a more abnormal pattern of pretreatment VS dynamic response to reward expectancy (expected outcome value) and prediction error (difference between expected and actual outcome), likely reflecting serotonergic and dopaminergic deficits, was associated with better response to sertraline than placebo. Pretreatment measures of reward-related VS activity may serve as objective neural markers to advance efforts to personalize interventions by guiding individual-level choice of antidepressant treatment.",2020,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","['depressed individuals', '222 unmedicated adults with MDD randomized to receive']","['placebo (n\u2009=\u2009112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task', 'sertraline', 'placebo', 'sertraline versus placebo']","['Hamilton Rating Scale for Depression (HSRD', 'depression symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",222.0,0.129786,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","[{'ForeName': 'Tsafrir', 'Initials': 'T', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. greenbergt@upmc.edu.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Stiffler', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Toups', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Peltier', 'Affiliation': 'Functional MRI Laboratory, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Departments of Psychiatry and Behavioral Science & Radiology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0490-5']
974,31591263,Absolute Quantification of Apolipoproteins Following Treatment with Omega-3 Carboxylic Acids and Fenofibrate Using a High Precision Stable Isotope-labeled Recombinant Protein Fragments Based SRM Assay.,"Stable isotope-labeled standard (SIS) peptides are used as internal standards in targeted proteomics to provide robust protein quantification, which is required in clinical settings. However, SIS peptides are typically added post trypsin digestion and, as the digestion efficiency can vary significantly between peptides within a protein, the accuracy and precision of the assay may be compromised. These drawbacks can be remedied by a new class of internal standards introduced by the Human Protein Atlas project, which are based on SIS recombinant protein fragments called SIS PrESTs. SIS PrESTs are added initially to the sample and SIS peptides are released on trypsin digestion. The SIS PrEST technology is promising for absolute quantification of protein biomarkers but has not previously been evaluated in a clinical setting. An automated and scalable solid phase extraction workflow for desalting and enrichment of plasma digests was established enabling simultaneous preparation of up to 96 samples. Robust high-precision quantification of 13 apolipoproteins was achieved using a novel multiplex SIS PrEST-based LC-SRM/MS Tier 2 assay in non-depleted human plasma. The assay exhibited inter-day coefficients of variation between 1.5% and 14.5% (median = 3.5%) and was subsequently used to investigate the effects of omega-3 carboxylic acids (OM3-CA) and fenofibrate on these 13 apolipoproteins in human plasma samples from a randomized placebo-controlled trial, EFFECT I (NCT02354976). No significant changes were observed in the OM3-CA arm, whereas treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels. The reduction in apoCIV following fenofibrate treatment is a novel finding. The study demonstrates that SIS PrESTs can facilitate the generation of robust multiplexed biomarker Tier 2 assays for absolute quantification of proteins in clinical studies.",2019,"No significant changes were observed in the OM3-CA arm, while treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels.",[],"['OM3-CA', 'Omega-3 Carboxylic Acids and Fenofibrate', 'Stable isotope-labeled standard (SIS) peptides', 'fenofibrate', 'omega-3 carboxylic acids (OM3-CA) and fenofibrate']","['apoAII and reduced apoB, apoCI, apoE and apoCIV levels']",[],"[{'cui': 'C3832882', 'cui_str': 'Omega-3 carboxylic acids'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.013594,"No significant changes were observed in the OM3-CA arm, while treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hober', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Edfors', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ryaboshapkina', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rosengren', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Percy', 'Affiliation': 'Department of Applications Development, Cambridge Isotope Laboratories, Inc., Tewksbury, MA 01876.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Forsström', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Uhlén', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'Global Medicines Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tasso', 'Initials': 'T', 'LastName': 'Miliotis', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden Tasso.Miliotis@astrazeneca.com.'}]",Molecular & cellular proteomics : MCP,['10.1074/mcp.RA119.001765']
975,31935026,Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,"Importance


Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data.
Objective


To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer.
Design, Setting, and Participants


The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017.
Interventions


Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241).
Main Outcomes and Measures


The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy.
Results


Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]).
Conclusions and Relevance


Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT01238172.",2020,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","['Men', '64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis', 'men with early-stage prostate cancer', 'men with early-stage prostate cancer managed with active surveillance', ""Participants\n\n\nThe Men's Eating and Living (MEAL) Study (CALGB 70807"", 'With Early-Stage Prostate Cancer', '478 patients randomized (mean [SD] age', '91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group\u2009=\u20091 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level', 'prostate cancer survivors']","['Guidelines endorsing vegetable-enriched diets', 'counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n\u2009=\u2009237) or a control group, which received written information about diet and prostate cancer (n\u2009=\u2009241', 'behavioral intervention that increased vegetable intake', 'Behavioral Intervention to Increase Vegetable Consumption']","['time to progression; progression', 'Cancer Progression', 'PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade', 'cancer progression', '24-month Kaplan-Meier progression-free percentages', 'time to progression', 'risk of prostate cancer progression', 'prostate cancer progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",478.0,0.259409,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","[{'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Hansel', 'Affiliation': 'Department of Pathology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Stroup', 'Affiliation': 'Department of Urology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Veldhuizen', 'Affiliation': 'Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.'}, {'ForeName': 'Lannis', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",JAMA,['10.1001/jama.2019.20207']
976,1309127,Selective assisted hatching of human embryos.,"Overall results of assisted hatching by zona drilling using acidic Tyrode's solution performed during three randomised trials in 330 in vitro fertilisation (IVF) patients are presented. It was demonstrated retrospectively and prospectively that assisted hatching by zona drilling was effective in embryos with thick zonae (> 15 microns). This procedure is called selective assisted hatching. In order to investigate whether the success rate of embryos with thin zonae (< 13 microns) can be improved further, a fourth trial was executed in 40 consenting patients. Embryos with thin zonae were left intact in one group (control), while the outside of zonae of similar embryos were thinned with acidic Tyrode's solution. Results thus far indicate that embryos with thin zonae do not benefit from this technique. Embryonic implantation (fetal heartbeat per embryo) was high (26%-27%) in both arms of the trial, probably as a result of selective zona drilling of low prognosis embryos with thick zonae. A method is presented for quantifying zona hardening in human embryos. The exposure to acidic Tyrode's solution of each embryo was expressed as a function of the duration to pierce the zona and the diameter of the needle. Preliminary findings suggested that embryonic viability is correlated with zona hardening. In order to test the hypothesis that extracellular fragments may affect embryonic viability, small amounts of fragments were removed from embryos during assisted hatching. The pregnancy rate in 36 patients with extracted fragments was relatively high (41%) considering the poor morphology of the embryos involved.",1992,The pregnancy rate in 36 patients with extracted fragments was relatively high (41%) considering the poor morphology of the embryos involved.,"['40 consenting patients', '330 in vitro fertilisation (IVF) patients', '36 patients with extracted fragments']","[""assisted hatching by zona drilling using acidic Tyrode's solution"", 'Embryonic implantation (fetal heartbeat per embryo']","['embryonic viability', 'pregnancy rate']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0455168', 'cui_str': 'Zona drilling (procedure)'}, {'cui': 'C0077548', 'cui_str': ""Tyrode's solution""}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",,0.0388136,The pregnancy rate in 36 patients with extracted fragments was relatively high (41%) considering the poor morphology of the embryos involved.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics and Gynecology, New York Hospital-Cornell University Medical Center, New York 10021.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Alikani', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Reing', 'Affiliation': ''}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Ferrara', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Trowbridge', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tucker', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
977,31465092,Efficacy and Safety of Retinal Gene Therapy Using Adeno-Associated Virus Vector for Patients With Choroideremia: A Randomized Clinical Trial.,"Importance


Choroideremia (CHM) is a rare, degenerative, genetic retinal disorder resulting from mutation of the CHM gene, leading to an absence of functional ras-associated binding escort protein 1 (REP1). There is currently no approved treatment for CHM.
Objective


To assess the safety and efficacy of retinal gene therapy with an adeno-associated virus vector (AAV2) designed to deliver a functional version of the CHM gene (AAV2-REP1) for treatment of patients with choroideremia.
Design, Setting, and Participants


Tübingen Choroideremia Gene Therapy (THOR) was a single-center, phase 2, open-label randomized clinical trial. Data were collected from January 11, 2016, to February 26, 2018. Twenty-four-month data are reported for 6 men with a molecularly confirmed diagnosis of CHM. Intention-to-treat analysis was used.
Interventions


Patients received AAV2-REP1 by a single, 0.1-mL subretinal injection of 1011 genome particles during vitrectomy into 1 eye randomly assigned to receive treatment.
Main Outcomes and Measures


Primary end point was change in best-corrected visual acuity (BCVA) on the Early Treatment Diabetic Retinopathy Study chart from baseline to month 24 in the treated eye vs the control eye. Secondary end points included microperimetry variables, change in fundus autofluorescence, and spectral-domain optical coherence tomographic evaluations from baseline to month 24 in the treated eye vs the control eye.
Results


On enrollment, the mean (SD) age of the 6 men included in the study was 54.9 (4.1) years. The mean (SD) BCVA score was 60.3 (13.4) (approximately 20/63 Snellen equivalent) in the study eyes and 69.3 (20.6) (approximately 20/40 Snellen equivalent) in the control eyes. At 24 months, the BCVA change was 3.7 (7.5) in the treated eyes and 0.0 (5.1) in the control eyes (difference, 3.7; 95% CI, -7.2 to 14.5; P = .43). Mean change in retinal sensitivity was 10.3 (5.5) dB in the treated eyes and 9.7 (4.9) dB in the control eyes (difference, 0.6; 95% CI, -10.2 to 11.4; P = .74). A total of 28 adverse events were reported; all were consistent with the surgical procedure (eg, conjunctival hyperemia, foreign body sensation), and none were regarded as severe.
Conclusions and Relevance


Among 6 participants, gene therapy with AAV2-REP1 was associated with maintenance or improvement of visual acuity, although no significant difference was found from control eyes. All safety issues were associated with the surgical procedure and none were judged severe. Continued investigations could more precisely define the efficacy and safety of gene therapy with AAV2-REP1 in CHM.
Trial Registration


ClinicalTrials.gov identifier: NCT02671539.",2019,"Conclusions and Relevance


Among 6 participants, gene therapy with AAV2-REP1 was associated with maintenance or improvement of visual acuity, although no significant difference was found from control eyes.","['6 men with a molecularly confirmed diagnosis of CHM', 'Patients With Choroideremia', 'Data were collected from January 11, 2016, to February 26, 2018', 'On enrollment, the mean (SD) age of the 6 men included in the study was 54.9 (4.1) years', 'patients with choroideremia']","['CHM gene (AAV2-REP1', 'retinal gene therapy with an adeno-associated virus vector (AAV2', 'Tübingen Choroideremia Gene Therapy (THOR', 'Importance\n\n\nChoroideremia (CHM', 'AAV2-REP1 by a single, 0.1-mL subretinal injection of 1011 genome particles during vitrectomy', 'Retinal Gene Therapy', 'Adeno-Associated Virus Vector']","['mean (SD) BCVA score', 'visual acuity', 'change in best-corrected visual acuity (BCVA', 'microperimetry variables, change in fundus autofluorescence, and spectral-domain optical coherence tomographic evaluations', 'BCVA change', 'Mean change in retinal sensitivity', 'Efficacy and Safety', 'surgical procedure (eg, conjunctival hyperemia, foreign body sensation', 'efficacy and safety', 'safety and efficacy']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008525', 'cui_str': 'Tapetochoroidal Dystrophy, Progressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy (procedure)'}, {'cui': 'C1564874', 'cui_str': 'Adeno-Associated Virus'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0008525', 'cui_str': 'Tapetochoroidal Dystrophy, Progressive'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0042776', 'cui_str': 'Virus'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation (finding)'}]",1011.0,0.175387,"Conclusions and Relevance


Among 6 participants, gene therapy with AAV2-REP1 was associated with maintenance or improvement of visual acuity, although no significant difference was found from control eyes.","[{'ForeName': 'M Dominik', 'Initials': 'MD', 'LastName': 'Fischer', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'G Alex', 'Initials': 'GA', 'LastName': 'Ochakovski', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Beier', 'Affiliation': 'STZ eyetrial at the Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Tübingen, Germany.'}, {'ForeName': 'Immanuel P', 'Initials': 'IP', 'LastName': 'Seitz', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Yousof', 'Initials': 'Y', 'LastName': 'Vaheb', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Constanze', 'Initials': 'C', 'LastName': 'Kortuem', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Felix F L', 'Initials': 'FFL', 'LastName': 'Reichel', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kuehlewein', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Nadine A', 'Initials': 'NA', 'LastName': 'Kahle', 'Affiliation': 'STZ eyetrial at the Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Tübingen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'STZ eyetrial at the Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Tübingen, Germany.'}, {'ForeName': 'Aniz', 'Initials': 'A', 'LastName': 'Girach', 'Affiliation': 'Nightstar Therapeutics, London, United Kingdom.'}, {'ForeName': 'Eberhart', 'Initials': 'E', 'LastName': 'Zrenner', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ueffing', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'MacLaren', 'Affiliation': 'Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Karl Ulrich', 'Initials': 'KU', 'LastName': 'Bartz-Schmidt', 'Affiliation': 'University Eye Hospital, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wilhelm', 'Affiliation': 'STZ eyetrial at the Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Tübingen, Germany.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.3278']
978,10672387,Use of EMLA cream or alfentanil for analgesia during ophthalmic nerve blocks.,"This prospective double-blind study compared the effectiveness of EMLA with alfentanil and placebo in reducing the overall pain during ophthalmic nerve blocks. Seventy-five patients scheduled for cataract surgery were divided into three groups. Patients in the EMLA group had EMLA cream applied over skin areas corresponding to injection sites for retrobulbar and facial nerve blocks one hour before the nerve blocks, and placebo intravenous normal-saline injection 2 minutes before the first nerve block. The alfentanil group had placebo cream applied and intravenous alfentanil 10 micrograms.kg-1 while patients in the placebo group received placebo cream and intravenous normal-saline at similar time intervals prior to the nerve blocks. Patients then received facial nerve blocks and retrobulbar block by the same surgeon. Pain scores by patients and independent observers were significantly lower in the EMLA and alfentanil groups compared to placebo (P < 0.005) with no significant difference between the EMLA and alfentanil groups.",1999,Pain scores by patients and independent observers were significantly lower in the EMLA and alfentanil groups compared to placebo (P < 0.005) with no significant difference between the EMLA and alfentanil groups.,['Seventy-five patients scheduled for cataract surgery'],"['EMLA cream', 'EMLA', 'placebo', 'placebo cream and intravenous normal-saline', 'alfentanil', 'facial nerve blocks and retrobulbar block', 'placebo cream', 'EMLA cream or alfentanil', 'EMLA with alfentanil and placebo']","['Pain scores', 'overall pain']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0360032', 'cui_str': 'EMLA Cream'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0394811', 'cui_str': 'Injection of anesthetic agent into facial nerve (procedure)'}, {'cui': 'C0583005', 'cui_str': 'Retrobulbar block'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",75.0,0.23414,Pain scores by patients and independent observers were significantly lower in the EMLA and alfentanil groups compared to placebo (P < 0.005) with no significant difference between the EMLA and alfentanil groups.,"[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Yoong', 'Affiliation': 'Department of Anaesthesia, Changi General Hospital, Singapore.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Fong', 'Affiliation': ''}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Koay', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
979,10748957,The role of alternative therapy in the management of partial thickness burns of the face--experience with the use of moist exposed burn ointment (MEBO) compared with silver sulphadiazine.,"INTRODUCTION


Conventional management of partial thickness facial burn wounds includes the use of silver sulphadiazine dressings. Silver sulphadiazine forms an overlying slough that makes wound healing assessment difficult. Moist exposed burn ointment (MEBO) has been proposed as the ideal burn wound dressing both for burns of the face and other sites. Proponents of MEBO claim that it accelerates wound healing and results in scarless wound healing and at the same time reduce bacterial colonisation and the need for analgesics. We present here our experience with MEBO in the management of partial thickness burns of the face.
MATERIALS AND METHODS


One hundred and fifteen patients with partial thickness burns were randomly assigned to conventional treatment or MEBO. Out of this, 112 were analysed. Thirty-nine patients sustained facial burns; 17 received MEBO and 22 received silver sulphadiazine. Patients were followed up daily until the burn wounds were reduced by 75% of original body surface area (BSA).
RESULTS


In patients with facial burns, MEBO was similar to silver sulphadiazine therapy with respect to rate of wound healing. Minimal slough was present over the wounds in MEBO-treated wounds resulting in clearer assessment of healing progression.
CONCLUSIONS


Advantages of MEBO as compared to silver sulphadiazine in the management of partial thickness burns of the face include convenient change of dressing and easier assessment of healing progression. This suggests that MEBO is a useful alternative therapy for partial thickness burns of the face.",2000,"In patients with facial burns, MEBO was similar to silver sulphadiazine therapy with respect to rate of wound healing.","['One hundred and fifteen patients with partial thickness burns', 'partial thickness burns of the face--experience', 'Thirty-nine patients sustained facial burns', 'partial thickness facial burn wounds']","['sulphadiazine dressings', 'silver sulphadiazine therapy', 'MEBO', 'Silver sulphadiazine', 'moist exposed burn ointment (MEBO', 'silver sulphadiazine', 'Moist exposed burn ointment (MEBO', 'conventional treatment or MEBO']",['rate of wound healing'],"[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0433163', 'cui_str': 'Burn of face'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0038675', 'cui_str': 'Sulfadiazine'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1174850', 'cui_str': 'moist exposed burn ointment'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",115.0,0.0113892,"In patients with facial burns, MEBO was similar to silver sulphadiazine therapy with respect to rate of wound healing.","[{'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Ang', 'Affiliation': 'Department of Plastic Surgery, Singapore General Hospital, Singapore.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'See', 'Affiliation': ''}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Machin', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
980,31463925,"Isometric handgrip training reduces blood pressure and wave reflections in East Asian, non-medicated, middle-aged and older adults: a randomized control trial.","PURPOSE


The aim of this study was to investigate the effects of isometric handgrip (IHG) training on central and peripheral blood pressure (BP) and wave reflections in East Asian non-medicated middle-aged and older adults.
METHODS


Twenty-two men and women (mean age 65 ± 11 years) who were not actively involved in regular resistance or endurance training were randomly assigned to a group that did IHG and a control (CON) group. The IHG training was comprised of four unilateral 2-min isometric contractions at 30% of maximal voluntary contraction using a programmed handgrip dynamometer with 1-min rest periods for 5 days per week for 8 weeks.
RESULTS


Baseline central systolic BP (cSBP), brachial systolic BP (bSBP), brachial diastolic BP (bDBP), and the augmentation index (AIx) (via an automated applanation tonometric system) did not differ significantly between the groups. Compared to baseline, cSBP, bSBP, bDBP, and AIx decreased significantly after the 8-week study period in the IHG group (P < 0.05). No significant changes in central and peripheral BP and AIx were observed in the CON group.
CONCLUSIONS


These results suggest that IHG training could reduce central and peripheral BP and wave reflections in East Asian non-medicated middle-aged and older adults.",2020,"No significant changes in central and peripheral BP and AIx were observed in the CON group.
","['East Asian, non-medicated, middle-aged and older adults', 'Twenty-two men and women (mean age 65\u2009±\u200911\xa0years) who were not actively involved in regular resistance or endurance training', 'East Asian non-medicated middle-aged and older adults']","['did IHG and a control (CON', 'IHG training', 'CON', 'isometric handgrip (IHG) training', 'Isometric handgrip training']","['cSBP, bSBP, bDBP, and AIx', 'central and peripheral BP and AIx', 'central and peripheral BP and wave reflections', 'central and peripheral blood pressure (BP) and wave reflections', 'blood pressure and wave reflections', 'Baseline central systolic BP (cSBP), brachial systolic BP (bSBP), brachial diastolic BP (bDBP), and the augmentation index (AIx) (via an automated applanation tonometric system']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0999177', 'cui_str': 'Genus Aix (organism)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",22.0,0.0303594,"No significant changes in central and peripheral BP and AIx were observed in the CON group.
","[{'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, 7-1-1, Fukasawa, Setagaya-ku, Tokyo, 158-8508, Japan. tokamoto@nittai.ac.jp.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, 7-1-1, Fukasawa, Setagaya-ku, Tokyo, 158-8508, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Fundamental Education, Teikyo University of Science, Tokyo, Japan.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01330-3']
981,9791656,Ambulatory anorectal surgery--is it feasible locally?,"Currently, anorectal procedures are done in an inpatient setting in most local hospitals. This study examines the feasibility of performing these procedures in an outpatient setting. Patients (age range 16 to 65 years) with anorectal complaints requiring surgery were randomized into 2 groups of 40 patients each. Procedures performed included haemorrhoidectomy, fistulotomy, lateral sphincterectomy, excision of rectal polyps and examination under anaesthesia. The first group was managed in the conventional inpatient setting with regional anaesthesia. The second group was done on an ambulatory basis with local anal block. Intravenous and oral ketorolac was used for postoperative pain control and patients were discharged about 4 hours postoperatively. No complications were noted in the second group while the first group had 2 cases of acute urine retention requiring temporary catheterisation and 2 cases of significant bleeding requiring hospitalisation. Pain and satisfaction scores for both groups were similar. Anorectal surgery can be performed in an outpatient setting locally with safety and efficacy. The cost savings can be significant.",1998,No complications were noted in the second group while the first group had 2 cases of acute urine retention requiring temporary catheterisation and 2 cases of significant bleeding requiring hospitalisation.,['Patients (age range 16 to 65 years) with anorectal complaints requiring surgery'],"['Intravenous and oral ketorolac', 'Anorectal surgery']","['bleeding requiring hospitalisation', 'haemorrhoidectomy, fistulotomy, lateral sphincterectomy, excision of rectal polyps and examination under anaesthesia', 'Pain and satisfaction scores', 'No complications', 'postoperative pain control', 'cost savings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0744044', 'cui_str': 'Fistulotomy'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0034887', 'cui_str': 'Rectal polyp (disorder)'}, {'cui': 'C0558588', 'cui_str': 'Examination under anesthesia (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",,0.0208834,No complications were noted in the second group while the first group had 2 cases of acute urine retention requiring temporary catheterisation and 2 cases of significant bleeding requiring hospitalisation.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Foo', 'Affiliation': 'Department of Surgery, Alexandra Hospital, Singapore.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sim', 'Affiliation': ''}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Ng', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
982,31453982,Paracetamol is ineffective for acute low back pain even for patients who comply with treatment: complier average causal effect analysis of a randomized controlled trial.,"In 2014, the Paracetamol for Acute Low Back Pain (PACE) trial demonstrated that paracetamol had no effect compared with placebo in acute low back pain (LBP). However, noncompliance was a potential limitation of this trial. The aim of this study was to investigate the efficacy of paracetamol in acute LBP among compliers. Using individual participant data from the PACE trial (ACTN12609000966291), complier average causal effect (CACE), intention-to-treat, and per protocol estimates were calculated for pain intensity (primary), disability, global rating of symptom change, and function (all secondary) after 2 weeks of follow-up. Compliance was defined as intake of an average of at least 4 of the prescribed 6 tablets of regular paracetamol per day (2660 mg in total) during the first 2 weeks after enrolment. Exploratory analyses using alternative time points and definitions of compliance were conducted. Mean between-group differences in pain intensity on a 0 to 10 scale using the primary time point and definition of compliance were not clinically relevant (propensity-weighted CACE 0.07 [-0.37 to 0.50] P = 0.76; joint modelling CACE 0.23 [-0.16 to 0.62] P = 0.24; intention-to-treat 0.11 [-0.20 to 0.42] P = 0.49; per protocol 0.29 [-0.07 to 0.65] P = 0.12); results for secondary outcomes and for exploratory analyses were similar. Paracetamol is ineffective for acute LBP even for patients who comply with treatment. This reinforces the notion that management of acute LBP should focus on providing patients advice and reassurance without the addition of paracetamol.",2019,p = 0.76; joint modelling CACE 0.23,"['acute low back pain among compliers', 'patients who comply with treatment']","['Paracetamol', 'paracetamol', 'placebo']","['Complier Average Causal Effects (CACE), Intention-to-treat (ITT) and Per Protocol (PP) estimates', 'pain intensity (primary), and disability, global rating of symptom change and function', 'pain intensity', 'acute low back pain (LBP']","[{'cui': 'C0457950', 'cui_str': 'Acute low back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain (finding)'}]",,0.133171,p = 0.76; joint modelling CACE 0.23,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Schreijenberg', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Mclachlan', 'Affiliation': 'Sydney Pharmacy School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'Hunter Medical Research Institute, School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Kamper', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Bart W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}]",Pain,['10.1097/j.pain.0000000000001685']
983,31404750,"Comparison of supplemental oxygen delivery by continuous versus demand based flow systems in hypoxemic COPD patients - A randomized, single-blinded cross-over study.","BACKGROUND


Supplemental oxygen is a recommended therapy option in stable hypoxemic COPD patients. Often, supplemental oxygen is provided by continuous flow (CF). However, demand oxygen delivery systems (DODS) that provide an oxygen bolus only during inspiration have gained increasing use as they prolong oxygen cylinder life (beside battery life). However, there is a lack of evidence if different DODS and CF devices are equivalent.
METHODS


Seventy hypoxemic COPD patients (FEV 1  32 ± 9% predicted, PaO 2  56±7 mmHg) on long-term oxygen therapy were included in this prospective single-blinded, randomized cross-over trial. Following an initial incremental shuttle walk test, patients performed 3 endurance shuttle walk tests (ESWT) at 85% of their maximum walking speed in random order with: (A) CF (ESWT-CF), (B) a DODS based on liquid oxygen (ESWT-DL) and (C) an DODS oxygen concentrator (ESWT-DC). The primary outcome was oxygen saturation (SpO 2 ) at ESWT isotime. Secondary outcomes were total ESWT duration, heart rate (HR) and breathing frequency (BF) at isotime and dyspnea at end-exercise.
RESULTS


SpO 2  at ESWT isotime was not clinically different between devices: 90 ± 4% (CF), 89 ± 5% (DL) and 90 ± 5% (DC). However, 20% of the patients showed a ≥4% lower oxygen desaturation while using a DODS device. Secondary outcomes were similar under the three conditions.
CONCLUSION


Oxygen supplementation via DODS (based on liquid oxygen or as a concentrator) yielded comparable physiological effects during standardized walking in stable hypoxemic COPD patients like CF. However, 20% of patients showed a clinically relevant lower oxygen saturation while using a DODS device. Therefore, we suggest individual testing of oxygen saturation of DODS suitability.",2019,"RESULTS


SpO 2  at ESWT isotime was not clinically different between devices: 90 ± 4% (CF), 89 ± 5% (DL) and 90 ± 5% (DC).","['stable hypoxemic COPD patients like CF', 'Seventy hypoxemic COPD patients (FEV 1  32\u202f±\u202f9% predicted, PaO 2  56±7\u202fmmHg) on long-term', 'hypoxemic COPD patients', 'stable hypoxemic COPD patients']","['oxygen therapy', 'endurance shuttle walk tests (ESWT) at 85% of their maximum walking speed in random order with: (A) CF (ESWT-CF), (B) a DODS based on liquid oxygen (ESWT-DL) and (C) an DODS oxygen concentrator (ESWT-DC', 'Oxygen supplementation via DODS', 'supplemental oxygen delivery by continuous versus demand based flow systems']","['total ESWT duration, heart rate (HR) and breathing frequency (BF) at isotime and dyspnea at end-exercise', 'oxygen saturation (SpO 2 ) at ESWT isotime', 'oxygen saturation', 'oxygen desaturation']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C1960627', 'cui_str': 'Endurance Shuttle Walk Test'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0260090', 'cui_str': 'Liquid oxygen (substance)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator (physical object)'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",,0.497577,"RESULTS


SpO 2  at ESWT isotime was not clinically different between devices: 90 ± 4% (CF), 89 ± 5% (DL) and 90 ± 5% (DC).","[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Gloeckl', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany; Department of Prevention, Rehabilitation and Sports Medicine, Technical University of Munich, Munich, Germany. Electronic address: rgloeckl@schoen-klinik.de.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany; Department of Pulmonary Rehabilitation, Philipps-University of Marburg, German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Fiedler', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Lausen', 'Affiliation': 'Department of Internal Medicine, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Weingaertner', 'Affiliation': 'Department of Internal Medicine, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hitzl', 'Affiliation': 'Research Office (Biostatistics), Paracelsus Medical University, Salzburg, Austria; Department of Ophthalmology and Optometry, Paracelsus Medical University, Salzburg, Austria; Research Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kenn', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany; Department of Pulmonary Rehabilitation, Philipps-University of Marburg, German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Andreas Rembert', 'Initials': 'AR', 'LastName': 'Koczulla', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany; Department of Pulmonary Rehabilitation, Philipps-University of Marburg, German Center for Lung Research (DZL), Marburg, Germany.'}]",Respiratory medicine,['10.1016/j.rmed.2019.08.001']
984,9919328,"Adjuvant chemotherapy in ""high risk"" patients after Wertheim hysterectomy--10-year survivals.","Although the primary operative mortality following radical hysterectomy for stage IB and early stage IIA cervical carcinoma is less than 1%, survival is poor in those patients with histological evidence of ""risk"" features--lymph node metastases, lymphatic vascular tumour permeation and clinically undetected parametrial metastases. In the 7-year period 1983 to 1989, 239 patients with stage IB and early IIA disease had radical hysterectomy and pelvic lymphadenectomy. One hundred and eight patients (45.2%) had various poor prognostic histological features and received adjuvant chemotherapy--70 had cisplatin, vinblastine, bleomycin (PVB), 16 had mitomycin C (MMC) and 22 others received mitomycin C + 5-fluorouracil (5-FU). Although not randomised, the risk factors present in each group were identical. These patients have now been followed up for periods ranging from 8 to 14 years. All recurrences, except one, occurred within 23 months of surgery; in the remaining this occurred 8 years later. This suggests that very close long-term follow-up is needed. Recurrences were markedly higher in the group who refused adjuvant chemotherapy (31.6%). The 10-year survival in patients without risk factors was 97.2%. In those patients with risk factors refusing adjuvant therapy it was 73.7%. The adjuvant chemotherapy group had a better survival of 86.1% (P = 0.001). The 10-year survivals in patients with positive nodes were similar--66.7% in the MMC group and 71.4% in the PVB group. The 10-year survival in patients with squamous cell carcinoma was significantly better (90.3%) in the mitomycin C (and MMC + 5-FU) group compared to the PVB group (80.1%) (P = 0.005). The 10-year survival in patients with adenocarcinoma and adenosquamous carcinoma was significantly better (96.3%) in the PVB group compared to those receiving MMC (and MMC + 5-FU) (57.1%) (P = 0.01). It would, thus, appear that the adjuvant chemotherapy of choice for patients with squamous cell carcinoma would be MMC (and MMC + 5-FU) and for those with adenocarcinoma, the PVB regime.",1998,The 10-year survivals in patients with positive nodes were similar--66.7% in the MMC group and 71.4% in the PVB group.,"['239 patients with stage IB and early IIA disease had radical hysterectomy and pelvic lymphadenectomy', 'high risk"" patients after Wertheim hysterectomy--10-year survivals', 'patients with squamous cell carcinoma', 'One hundred and eight patients (45.2%) had various poor prognostic histological features and received']","['adjuvant chemotherapy--70 had cisplatin, vinblastine, bleomycin (PVB), 16 had mitomycin C (MMC', 'Adjuvant chemotherapy', 'mitomycin C + 5-fluorouracil (5-FU', 'mitomycin C (and MMC + 5-FU', 'MMC (and MMC + 5-FU', 'radical hysterectomy', 'MMC']","['Recurrences', '10-year survival', 'survival', '10-year survivals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457152', 'cui_str': 'Stage Ib'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0195305', 'cui_str': 'Wertheim operation (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",239.0,0.0514207,The 10-year survivals in patients with positive nodes were similar--66.7% in the MMC group and 71.4% in the PVB group.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sivanesaratnam', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]","Annals of the Academy of Medicine, Singapore",[]
985,9919351,Postanaesthetic shivering--a comparison of thiopentone and propofol.,One hundred and sixty patients undergoing minor surgical procedures were randomly allocated to receive either thiopentone or propofol for induction of anaesthesia. All patients were assessed in the recovery period for the development of postanaesthetic shivering. Twenty patients (25%) in the thiopentone group and 8 patients (10%) in the propofol group developed postanaesthetic shivering (p < 0.05). There was no statistically significant difference in tympanic temperature between shivering and nonshivering patients. Propofol as an induction agent is associated with a lower incidence of postanaesthetic shivering as compared to thiopentone.,1998,Propofol as an induction agent is associated with a lower incidence of postanaesthetic shivering as compared to thiopentone.,['One hundred and sixty patients undergoing minor surgical procedures'],"['thiopentone', 'thiopentone and propofol', 'Propofol', 'propofol', 'thiopentone or propofol']","['postanaesthetic shivering', 'tympanic temperature']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgery'}]","[{'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}]",160.0,0.0134098,Propofol as an induction agent is associated with a lower incidence of postanaesthetic shivering as compared to thiopentone.,"[{'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Cheong', 'Affiliation': 'Department of Anaesthesia, National University Hospital, Singapore.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Yau', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
986,9777083,Caudal morphine in paediatric patients: a comparison of two different doses in children after major urogenital surgery.,"We compared the duration of postoperative analgesia and the occurrence of side-effects of two different doses of caudal morphine in children undergoing major urogenital surgery. Fifty-two children aged between 1 and 12 years were randomly selected to receive caudal morphine, either 25 micrograms.kg-1 (Group A) or 50 micrograms.kg-1 (Group B) with 0.5 ml kg-1 of 0.25% plain bupivacaine immediately before surgery. They were monitored for 24 hours in a high dependency area for known complications of epidural morphine. There was no significant difference in postoperative analgesia between the two doses of caudal morphine. Clinically significant respiratory depression or sedation was not detected in either group. The occurrence of vomiting and pruritus was similar in both groups. Urinary retention was not recorded as all children had an indwelling catheter as required by the surgical procedure. We concluded that 25 micrograms.kg-1 of caudal morphine is as effective as 50 micrograms.kg-1 for providing postoperative analgesia in children undergoing urogenital surgery.",1998,There was no significant difference in postoperative analgesia between the two doses of caudal morphine.,"['children after major urogenital surgery', 'paediatric patients', 'children undergoing major urogenital surgery', 'children undergoing urogenital surgery', 'Fifty-two children aged between 1 and 12 years']","['caudal morphine, either 25 micrograms.kg-1 (Group A) or 50 micrograms.kg-1 (Group B) with 0.5 ml kg-1 of 0.25% plain bupivacaine', 'caudal morphine', 'Caudal morphine']","['Urinary retention', 'postoperative analgesia', 'respiratory depression or sedation', 'occurrence of vomiting and pruritus']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",52.0,0.0817248,There was no significant difference in postoperative analgesia between the two doses of caudal morphine.,"[{'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Leong', 'Affiliation': 'Department of Anaesthesia & Surgical Intensive Care, Singapore General Hospital, Singapore.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Chew', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
987,10101560,A randomized trial of the use of print material and personal contact to improve mammography uptake among screening non-attenders in Singapore.,"The Singapore Breast Screening Project was a nationwide study inviting a random sample of women between the ages of 50 and 64 years for mammography at one of two hospital-based screening centres over two years. The current study was undertaken to determine if (1) mailed health educational material alone, or (2) the same material delivered during a home visit made to the subject and her family would increase the uptake among Singapore women who had not responded to two previous invitations for mammographic screening as part of the Project. This randomized trial employed a standard second reminder letter (R), the same letter packaged with health education material designed for the project (RP) and the addition of a home visit to make contact with the woman and her family (RV). The outcome measure of interest was the proportion of women in each group subsequently attending for screening. The study population comprised 1500 non-attenders whose names appeared consecutively in the database of the larger screening centre in this Project. These were randomized into three groups of 500 each. In total, they broadly resembled the national population in ethnic composition (72.3% Chinese, 17.8% Malays, 9.0% Indians and 0.8% Others). By the end of the project, 7.0% of women in group R and 7.6% in group RP responded to the invitation. In group RV, 428 homes were visited at least once and contact was made with the subject and her family member in 306 (71.5%) cases. Subsequently, 13.3% of the women visited attended for screening. The rate ratio for attendance in group RP compared with group R was 1.09 (95% CI 0.70 to 1.70) and for group RV compared with R, 1.90 (1.27 to 2.84). When analyzed by groups originally assigned to, women in group RV remained significantly more likely to attend than those in groups R or RP. The marginal cost of a home visit, based on this study, was $25.04 per additional woman screened. Our results suggest that the response to a second reminder is generally low and that additional print material does not improve screening attendance in this group of initial non-attenders. Personal contact with the family through a home visit appears to increase uptake, and may be helpful particularly among women who have less frequent contact with the health care system.",1998,"The rate ratio for attendance in group RP compared with group R was 1.09 (95% CI 0.70 to 1.70) and for group RV compared with R, 1.90 (1.27 to 2.84).","['1500 non-attenders whose names appeared consecutively in the database of the larger screening centre in this Project', 'screening non-attenders in Singapore', 'random sample of women between the ages of 50 and 64 years for mammography at one of two hospital-based screening centres over two years', 'Singapore women who had not responded to two previous invitations for mammographic screening as part of the Project', 'women who have less frequent contact with the health care system']","['print material and personal contact', 'standard second reminder letter (R), the same letter packaged with health education material designed for the project (RP']","['rate ratio for attendance', 'mammography uptake', 'screening attendance']","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C0034036', 'cui_str': 'Publications'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0018701'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",428.0,0.0225965,"The rate ratio for attendance in group RP compared with group R was 1.09 (95% CI 0.70 to 1.70) and for group RV compared with R, 1.90 (1.27 to 2.84).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Seow', 'Affiliation': 'Department of Community, Occupational and Family Medicine, Medical Faculty MD3, National University of Singapore, Singapore.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Straughan', 'Affiliation': ''}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Lee', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
988,31435578,The effect of sexual health counseling on women's sexual satisfaction in postpartum period: A randomized clinical trial.,"Background


Many couples experience decreasing sexual satisfaction in postpartum period. Various sexual health counseling approaches have been designed for postpartum women to address their common sexual concerns and problems.
Objective


This study aimed to investigate the effectiveness of Women's Postpartum Sexual Health Program (WPSHP) on women's sexual satisfaction in postpartum period.
Materials and Methods


The study was a single blind randomized clinical trial on 75 postpartum women aged 18-35 yr with low sexual satisfaction who attended urban health-care centres in Mashhad, Iran in 2016. Data were collected using a demographic questionnaire, the Depression Anxiety Stress Scales-21, and the Larson Sexual Satisfaction Questionnaire. The intervention group received counselling based on the WPSHP, a four-session, group- and couples-based program. The control group just received postpartum routine care.
Results


Both the intervention and control groups were homogeneous for demographic variables. According to the Mann-Whitney test, sexual satisfaction score in the intervention group was significantly higher than the control group 8 weeks after the intervention (p  <  0.001). According to the Wilcoxon test, there was a significant difference in the mean score of sexual satisfaction before and after intervention in the intervention group (p  <  0.001).
Conclusion


WPSHP caused higher levels of sexual satisfaction. It is therefore recommended to use this program in women during the postpartum period to promote their sexual satisfaction.",2019,"According to the Mann-Whitney test, sexual satisfaction score in the intervention group was significantly higher than the control group 8 weeks after the intervention (p  <  0.001).","[""women's sexual satisfaction in postpartum period"", '75 postpartum women aged 18-35 yr with low sexual satisfaction who attended urban health-care centres in Mashhad, Iran in 2016']","['postpartum routine care', ""Women's Postpartum Sexual Health Program (WPSHP"", 'sexual health counseling', 'WPSHP', 'counselling based on the WPSHP, a four-session, group- and couples-based program']","['sexual satisfaction', 'demographic questionnaire, the Depression Anxiety Stress Scales-21, and the Larson Sexual Satisfaction Questionnaire', 'sexual satisfaction score', 'mean score of sexual satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0041933', 'cui_str': 'Urban Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",75.0,0.0504761,"According to the Mann-Whitney test, sexual satisfaction score in the intervention group was significantly higher than the control group 8 weeks after the intervention (p  <  0.001).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zamani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Latifnejad Roudsari', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Moradi', 'Affiliation': 'Nursing and Midwifery Care Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Esmaily', 'Affiliation': 'Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i1.3819']
989,31435585,The efficacy of group counselling on perceived stress among infertile women undergoing in vitro fertilization treatment: An RCT.,"Background


One of the stressful and critical experiences that threat the individual, family, marital, and social stability is infertility.
Objective


To identify the effects of midwifery-led counselling programs on the perceived stress of the women undergoing assisted reproductive treatment.
Materials and Methods


In this randomized clinical trial, 50 infertile women who underwent in vitro fertilization treatment for the first time were enrolled in two groups. The intervention group received six sessions of group counselling by M.Sc. midwifery of counseling student and the control group received only the routine care. All participants filled Newton's standard questionnaire before and at the time of puncture, embryo transfer and the pregnancy test.
Results


The mean  ±  SD scores for the perceived infertility stress before the intervention in the control and the intervention groups were 167.92  ±  12.14 and 166.75  ±  13.27, respectively. The mean of perceived stress after intervention at the time of oocyte puncture in the control and case group were 177.12  ±  19.37 and 115.75  ±  13.88, at the time of embryo transfer were 179.40  ±  18.34 and 118.08  ±  15.37, and at the time of pregnancy test was 183.76  ±  14.97 and 120.50  ±  16.24, respectively. The perceived stress of infertility after intervention were statistically significant in the two group (p  ≤  0.001).
Conclusion


Group counselling is one of the effective methods for reducing the perceived stress in the women undergoing assisted reproductive treatment.",2019,"The mean of perceived stress after intervention at the time of oocyte puncture in the control and case group were 177.12  ±  19.37 and 115.75  ±  13.88, at the time of embryo transfer were 179.40  ±  18.34 and 118.08  ±  15.37, and at the time of pregnancy test was 183.76  ±  14.97 and 120.50  ±  16.24, respectively.","['50 infertile women who underwent in vitro fertilization treatment for the first time were enrolled in two groups', 'infertile women undergoing in vitro fertilization treatment', 'women undergoing assisted reproductive treatment']","['six sessions of group counselling by M.Sc', 'midwifery-led counselling programs']","['mean  ±  SD scores for the perceived infertility stress', 'mean of perceived stress', 'perceived stress of infertility']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0518001,"The mean of perceived stress after intervention at the time of oocyte puncture in the control and case group were 177.12  ±  19.37 and 115.75  ±  13.88, at the time of embryo transfer were 179.40  ±  18.34 and 118.08  ±  15.37, and at the time of pregnancy test was 183.76  ±  14.97 and 120.50  ±  16.24, respectively.","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Hamzehgardeshi', 'Affiliation': 'Sexual and Reproductive Health Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Yazdani', 'Affiliation': 'Midwifery Counseling, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Forouzan', 'Initials': 'F', 'LastName': 'Elyasi', 'Affiliation': 'Department of Psychiatry, Psychiatry and Behavioral Sciences Research Center, Addiction Institute, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Moosazadeh', 'Affiliation': 'Health Science Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Peyvandi', 'Affiliation': 'IVF Ward, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Keshvar', 'Initials': 'K', 'LastName': 'Samadaee Gelehkolaee', 'Affiliation': 'Department of Reproductive Health and Midwifery, Tehran Nursing and Midwifery Faculty, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahidi', 'Affiliation': 'Department of Medical Physics, Mazandaran Medical University, Mazandaran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i1.3821']
990,31435593,Evaluation of the metformin effects on Anti-Müllerian Hormone in women with polycystic ovarian syndrome: A double-blind randomized clinical trial.,,2019,,['women with polycystic ovarian syndrome'],['metformin'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]",[],,0.661296,,"[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rahmanian', 'Affiliation': ''}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i2.3992']
991,31435605,Immediate dilation of a tight or stenotic cervix by intra-procedural administration of hyoscine butylbromide: A clinical trial.,"Background


Cervical dilation is indicated prior to performing various gynecological procedures. However, gynecologists are at times confronted with a stenotic or tight cervix, resistant to dilation. This can be problematic particularly when cervical ripening has not been attempted hours before the start of the procedure.
Objective


The objective of this study is to investigate the efficacy of administration of hyoscine butylbromide for cervical dilation for immediate dilation of the tight or stenotic cervix.
Materials and Methods


In this clinical trial study, a population of 40 women, aged 20-70 yr with stenotic cervix, evidenced by resistance to pass dilator #2 through their cervical canal were compared. Cervical patency was assessed 10 min following intra-cervical canal instillation of hyoscine butylbromide.
Results


Cervical width of 57.5% of patients became wider, as evidenced by passage of the number 4 Hegar dilator through the cervical canal without resistance. Independent  T -tests did not reveal any statistically significant difference between the two groups based on their age. Fisher Exact test revealed a statistically significant difference between the two groups based on the prior route of delivery, with a more statistically significant response in patients who had vaginal deliveries.
Conclusion


Intra-cervical canal instillation of hyoscine butylbromide is effective in immediate dilation of the tight or stenotic cervix during intra-uterine procedures.",2019,"Conclusion


Intra-cervical canal instillation of hyoscine butylbromide is effective in immediate dilation of the tight or stenotic cervix during intra-uterine procedures.","['a population of 40 women, aged 20-70 yr with stenotic cervix, evidenced by resistance to pass dilator #2 through their cervical canal were compared', 'patients who had vaginal deliveries']",['hyoscine butylbromide'],['Cervical patency'],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0227841', 'cui_str': 'Cervical canal structure (body structure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]","[{'cui': 'C0006519', 'cui_str': 'butylscopolamine bromide'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",40.0,0.177992,"Conclusion


Intra-cervical canal instillation of hyoscine butylbromide is effective in immediate dilation of the tight or stenotic cervix during intra-uterine procedures.","[{'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Hadadianpour', 'Affiliation': 'Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Tavana', 'Affiliation': 'University of Texas South West (UTSW), Dallas, Texas, USA.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Tavana', 'Affiliation': 'University of Texas Medical Branch (UTMB), Texas, USA.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Fallahian', 'Affiliation': 'Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i4.4550']
992,10497668,A study to assess the effect of dietary supplementation with soluble fibre (Minolest) on lipid levels in normal subjects with hypercholesterolaemia.,"Hypercholesterolaemia is one of the major risk factors in the development of coronary artery disease. In recent years, many nonprescription treatments have become available for cholesterol lowering. Minolest is a product that contains guar gum and psyllium as the principal active ingredients. We conducted a randomised, placebo-controlled, double-blind, parallel-group study to assess the efficacy of Minolest as a lipid-lowering agent. Secondary aims included assessment of the effect on blood pressure and obesity. We also looked at the acceptability of the product and side effects associated with its ingestion. After a 4-week run-in period, 83 subjects were randomised to receive placebo or Minolest (16.5 g/day) for 3 months. Seven subjects defaulted follow up, 5 in the placebo group and 2 in the active treatment group. In addition, 9 subjects (5 on active treatment and 4 on placebo) had total cholesterol fall into the optimal range (< 5.2 mmol/l) during the run-in phase and were removed from the study. At baseline in the active treatment group, total cholesterol was 6.1 (5.43 to 8.06) mmol/l, triglyceride 1.54 (0.56 to 4.19) mmol/l, HDL cholesterol 1.32 +/- 0.43 mmol/l and LDL cholesterol 4.1 (3.10 to 6.27) mmol/l. In the placebo group, total cholesterol was 5.84 (5.32 to 8.38) mmol/l, triglyceride 1.47 (0.69 to 11.0) mmol/l, HDL cholesterol 1.15 +/- 0.33 mmol/l and LDL cholesterol 3.87 (2.46 to 5.14) mmol/l. The differences in the baseline characteristics were not statistically significant except the LDL-cholesterol. Minolest produced a 3.24% (SD = 7.85%, P = 0.020) decrease in total cholesterol and 5.45% decrease in LDL cholesterol (SD = 10.25%, P = 0.0034) but no significant difference in serum triglyceride, weight, body mass index or blood pressure. This was not seen in the placebo group. The percentage fall in LDL cholesterol increased to 7.16% and 7.37% in subjects who consumed at least 50% and 70% of the treatment respectively. There were few side effects. The authors conclude that this product has a small impact on the lipid profile and may be useful only in subjects with mild hypercholesterolaemia and a low risk of coronary artery disease.",1999,"Minolest produced a 3.24% (SD = 7.85%, P = 0.020) decrease in total cholesterol and 5.45% decrease in LDL cholesterol (SD = 10.25%, P = 0.0034) but no significant difference in serum triglyceride, weight, body mass index or blood pressure.","['9 subjects (5 on active treatment and 4 on', '83 subjects', 'subjects with mild hypercholesterolaemia and a low risk of coronary artery disease', 'normal subjects with hypercholesterolaemia']","['Hypercholesterolaemia', 'placebo or Minolest', 'placebo', 'dietary supplementation with soluble fibre (Minolest']","['total cholesterol fall', 'serum triglyceride, weight, body mass index or blood pressure', 'lipid levels', 'total cholesterol', 'LDL cholesterol', 'blood pressure and obesity', 'LDL-cholesterol']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",83.0,0.221137,"Minolest produced a 3.24% (SD = 7.85%, P = 0.020) decrease in total cholesterol and 5.45% decrease in LDL cholesterol (SD = 10.25%, P = 0.0034) but no significant difference in serum triglyceride, weight, body mass index or blood pressure.","[{'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Tai', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore. eshyong@pacific.net.sg'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Fok', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Tan', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
993,10561764,The outcome of trial off catheter after acute retention of urine.,"The aim of this study was to analyse the outcome of trial off catheter for patients who were admitted to the Department of Urology, Singapore General Hospital (SGH) for acute retention of urine (ARU) due to benign prostatic hypertrophy (BPH). From 1 June to 15 October 1997, 150 patients were admitted for ARU. Seventy-one patients were excluded from our study due to our exclusion criteria such as chronic retention, patients with bladder stones and cancer of the prostate. Our results showed that 58% (n = 46) had a successful trial off catheter. The risk factors for failure were: high residual urine (more than 800 ml) and high prostatic specific antigen (PSA) value (10.9 versus 21.5). All patients with normal PSA value (< 4 ng/l) had successful trial off catheters. There was no difference between trial off catheter 24 hours versus 48 hours after admission.",1999,There was no difference between trial off catheter 24 hours versus 48 hours after admission.,"['Seventy-one patients were excluded from our study due to our exclusion criteria such as chronic retention, patients with bladder stones and cancer of the prostate', 'From 1 June to 15 October 1997, 150 patients were admitted for ARU', 'All patients with normal PSA value (< 4 ng/l) had successful trial off catheters', 'patients who were admitted to the Department of Urology, Singapore General Hospital (SGH) for acute retention of urine (ARU) due to benign prostatic hypertrophy (BPH']",[],"['successful trial off catheter', 'high prostatic specific antigen (PSA) value']","[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2712342', 'cui_str': 'Bladder stone (substance)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine (disorder)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]",[],"[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",150.0,0.0830222,There was no difference between trial off catheter 24 hours versus 48 hours after admission.,"[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Lim', 'Affiliation': 'Department of Urology, Singapore General Hospital.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Foo', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
994,31436165,The Elusive Path Toward Measuring Health Outcomes: Lessons Learned From a Pseudo-Randomized Controlled Trial of a Large-Scale Mobile Health Initiative.,"Mobile health (mHealth) offers new opportunities to improve access to health services and health information. It also presents new challenges in evaluating its impact, particularly in linking the use of a technology intervention that aims to improve health behaviors with the health outcomes that are impacted by changed behaviors. The availability of data from a multitude of sources (paper-based and electronic) provides the conditions to facilitate making stronger connections between self-reported data and clinical outcomes. This commentary shares lessons and important considerations based on the experience of applying new research frameworks and incorporating maternal and child health records data into a pseudo-randomized controlled trial to evaluate the impact of mMitra, a stage-based voice messaging program to improve maternal, newborn, and child health outcomes in urban slums in India.",2019,"It also presents new challenges in evaluating its impact, particularly in linking the use of a technology intervention that aims to improve health behaviors with the health outcomes that are impacted by changed behaviors.",['urban slums in India'],[],['Health Outcomes'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0516516,"It also presents new challenges in evaluating its impact, particularly in linking the use of a technology intervention that aims to improve health behaviors with the health outcomes that are impacted by changed behaviors.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mechael', 'Affiliation': 'HealthEnabled, Washington, DC, United States.'}, {'ForeName': 'Nadi Nina', 'Initials': 'NN', 'LastName': 'Kaonga', 'Affiliation': 'All of Us Research Program, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Subhashini', 'Initials': 'S', 'LastName': 'Chandrasekharan', 'Affiliation': 'All of Us Research Program, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Muthu Perumal', 'Initials': 'MP', 'LastName': 'Prakash', 'Affiliation': 'Foundation for Research in Health Systems, Chennai, India.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'Johnson & Johnson, Cape Town, South Africa.'}, {'ForeName': 'Aakash', 'Initials': 'A', 'LastName': 'Ganju', 'Affiliation': 'Saati Health, Mumbai, India.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Murthy', 'Affiliation': 'Foundation for Research in Health Systems, Bengaluru, India.'}]",JMIR mHealth and uHealth,['10.2196/14668']
995,32058555,Evaluation of Prediction Models for Identifying Malignancy in Pulmonary Nodules Detected via Low-Dose Computed Tomography.,"Importance


Malignancy prediction models based on participant-related characteristics and imaging parameters from low-dose computed tomography (CT) may improve decision-making regarding nodule management and diagnosis in lung cancer screening.
Objective


To externally validate 5 malignancy prediction models that were developed in screening settings, compared with 3 models that were developed in clinical settings, in terms of discrimination and absolute risk calibration among participants in the German Lung Cancer Screening Intervention trial.
Design, Setting, and Participants


In this population-based diagnostic study, malignancy probabilities were estimated by applying 8 prediction models to data from 1159 participants in the intervention arm of the Lung Cancer Screening Intervention trial, a randomized clinical trial conducted from October 23, 2007, to April 30, 2016, with ongoing follow-up. This analysis considers end points up to 1 year after individuals' last screening visit. Inclusion criteria for participants were at least 1 noncalcified pulmonary nodule detected on any of 5 annual screening visits, receiving a lung cancer diagnosis within the active screening phase of the Lung Cancer Screening Intervention trial, and an unequivocal identification of the malignant nodules. Data analysis was performed from February 1, 2019, through December 5, 2019.
Interventions


Five annual rounds of low-dose multislice CT.
Main Outcomes and Measures


Discrimination ability and calibration of malignancy probabilities estimated by 5 models developed in data from screening studies (4 Pan-Canadian Early Detection of Lung Cancer Study [PanCan] models using a parsimonious approach including nodule spiculation [PanCan-1b] or a comprehensive approach including nodule spiculation [PanCan-2b], and PanCan-2b replacing the nodule diameter variable with mean diameter [PanCan-MD] or volume [PanCan-VOL], as well as a model developed by the UK Lung Cancer Screening trial) and 3 models developed in clinical settings (US Department of Veterans Affairs, Mayo Clinic, and Peking University People's Hospital).
Results


A total of 1159 participants (median [range] age, 57.63 [50.34-71.89] years; 763 [65.8%] men) with 3903 pulmonary nodules were included in this study. For nodules detected in the prevalence round of CT, the PanCan models showed excellent discrimination (PanCan-1b: area under the curve [AUC], 0.93 [95% CI, 0.87-0.99]; PanCan-2b: AUC, 0.94 [95% CI, 0.89-0.99]; PanCan-MD: AUC, 0.94 [95% CI, 0.91-0.98]; PanCan-VOL: AUC, 0.94 [95% CI, 0.90-0.98]), and all of the screening models except PanCan-MD and PanCan-VOL showed acceptable calibration (PanCan-1b: Spiegelhalter z = -1.081; P = .28; PanCan-2b: Spiegelhalter z = 0.436; P = .67; PanCan-MD: Spiegelhalter z = 3.888; P < .001; PanCan-VOL: Spiegelhalter z = 1.978; P = .05; UK Lung Cancer Screening trial: Spiegelhalter z = -1.076; P = .28), whereas the other models showed worse discrimination and calibration, from an AUC of 0.58 (95% CI, 0.46-0.70) for the UK Lung Cancer Screening trial model to an AUC of 0.89 (95% CI, 0.82-0.97) for the Mayo Clinic model.
Conclusions and Relevance


This diagnostic study found that PanCan models showed excellent discrimination and calibration in prevalence screenings, confirming their ability to improve nodule management in screening settings, although calibration to nodules detected in follow-up scans should be improved. The models developed by the Mayo Clinic, Peking University People's Hospital, Department of Veterans Affairs, and UK Lung Cancer Screening Trial did not perform as well.",2020,"Spiegelhalter z = 1.978; P = .05; UK Lung Cancer Screening trial: Spiegelhalter z = -1.076; P = .28), whereas the other models showed worse discrimination and calibration, from an AUC of 0.58 (95% CI, 0.46-0.70) for the UK Lung Cancer Screening trial model to an AUC of 0.89 (95% CI, 0.82-0.97) for the Mayo Clinic model.
","['Inclusion criteria for participants were at least 1 noncalcified pulmonary nodule detected on any of 5 annual screening visits, receiving a lung cancer diagnosis within the active screening phase of the Lung Cancer Screening Intervention trial, and an unequivocal identification of the malignant nodules', '1159 participants (median [range] age, 57.63', 'participants in the German Lung Cancer Screening Intervention trial', '1159 participants in the intervention arm of the Lung Cancer Screening Intervention trial, a randomized clinical trial conducted from October 23, 2007, to April 30, 2016, with ongoing follow-up', '50.34-71.89] years; 763 [65.8%] men) with 3903 pulmonary nodules']",['low-dose computed tomography (CT'],"[""nodule spiculation [PanCan-1b] or a comprehensive approach including nodule spiculation [PanCan-2b], and PanCan-2b replacing the nodule diameter variable with mean diameter [PanCan-MD] or volume [PanCan-VOL], as well as a model developed by the UK Lung Cancer Screening trial) and 3 models developed in clinical settings (US Department of Veterans Affairs, Mayo Clinic, and Peking University People's Hospital""]","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",1159.0,0.249074,"Spiegelhalter z = 1.978; P = .05; UK Lung Cancer Screening trial: Spiegelhalter z = -1.076; P = .28), whereas the other models showed worse discrimination and calibration, from an AUC of 0.58 (95% CI, 0.46-0.70) for the UK Lung Cancer Screening trial model to an AUC of 0.89 (95% CI, 0.82-0.97) for the Mayo Clinic model.
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'González Maldonado', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Delorme', 'Affiliation': 'Division of Radiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Hüsing', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Motsch', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Claus-Peter', 'Initials': 'CP', 'LastName': 'Heussel', 'Affiliation': 'Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kaaks', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.21221']
996,9208074,Sedation for the conduct of lumbar epidural anaesthesia: a study using subanaesthetic dose of ketamine in combination with midazolam.,"We gave sedation for the conduct of lumbar epidural analgesia using intravenous ketamine 0.3 mg.kg-1 with intravenous midazolam 2 mg. Forty adult Chinese females undergoing major gynaecological laparotomies had epidural catheter inserted before general anaesthesia, 20 of whom were given ketamine and midazolam (study group) and the other 20 acted as control. During the conduct of the epidural, the pain and anxiety scores in the study group were significantly less than the control group (P < 0.05). Patients were significantly more sedated in the study group (P < 0.05). All the patients in the study group were satisfied and would consent to future epidural versus 75% in the control group (significant at P < 0.05). Ninety per cent of patients in the study group had amnesia but none in the control group. Pain experienced during the epidural was the reason for refusal of future epidural. We did not observe any emergence phenomenon or cardiovascular stimulation. There was a statistically significant decrease in the pulse oximetry oxygen saturation (SpO2) in the study group but none required oxygen supplementation. We concluded that pain caused by the conduct of epidural did decrease the patient's acceptance rate to future epidural, and the combined use of intravenous ketamine 0.3 mg.kg-1 and midazolam 2 mg provided adequate sedation, analgesia, anxiolysis and amnesia to significantly increase the acceptance rate without any significant side effects.",1997,"During the conduct of the epidural, the pain and anxiety scores in the study group were significantly less than the control group (P < 0.05).","['Forty adult Chinese females undergoing major gynaecological laparotomies had epidural catheter inserted before general anaesthesia, 20 of whom were given', 'lumbar epidural anaesthesia']","['ketamine and midazolam', 'ketamine 0.3 mg.kg-1 with intravenous midazolam', 'ketamine', 'midazolam']","['pulse oximetry oxygen saturation (SpO2', 'pain and anxiety scores', 'Pain', 'amnesia', 'satisfied and would consent to future epidural', 'acceptance rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter, device (physical object)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002622', 'cui_str': 'Amnesia-Memory Loss'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0380583,"During the conduct of the epidural, the pain and anxiety scores in the study group were significantly less than the control group (P < 0.05).","[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Loo', 'Affiliation': 'Department of Anaesthesia, Kandang Kerbau Hospital, Singapore.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Yeo', 'Affiliation': ''}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Sia', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
997,9395803,Preoperative versus postoperative pethidine for extraction of impacted third molars.,"We have studied the pre-emptive analgesic effects of pethidine by comparing its analgesic effects given before or immediately after operation in a randomized, double-blind study of 40 patients undergoing removal of bilateral impacted third molars under general anaesthesia. Group 1 patients received pethidine 50 mg as a 1 ml injection 1 to 2 hours before operation and normal saline 1 ml intramuscularly immediately after surgery. Group 2 patients received normal saline 1 ml intramuscularly before operation and pethidine 50 mg as a 1 ml injection immediately after surgery. Outcome measures included perception of pain on a visual analogue scale (VAS), the number of patients who required postoperative pethidine, time to first postoperative pethidine injection and total dose of pethidine given. Four patients in group 1 compared to 8 in group 2 required postoperative pethidine but this was not statistically significant. The VAS scores, time to first postoperative pethidine injection and total dose of pethidine also did not differ significantly between the 2 groups. We concluded that preoperative administration of pethidine intramuscularly did not confer additional analgesic effects compared with a similar dose given after surgery.",1997,"The VAS scores, time to first postoperative pethidine injection and total dose of pethidine also did not differ significantly between the 2 groups.",['40 patients undergoing removal of bilateral impacted third molars under general anaesthesia'],"['pethidine', 'normal saline 1 ml intramuscularly before operation and pethidine']","['VAS scores, time to first postoperative pethidine injection and total dose of pethidine', 'postoperative pethidine', 'additional analgesic effects', 'perception of pain on a visual analogue scale (VAS), the number of patients who required postoperative pethidine, time to first postoperative pethidine injection and total dose of pethidine given']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",40.0,0.165632,"The VAS scores, time to first postoperative pethidine injection and total dose of pethidine also did not differ significantly between the 2 groups.","[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Chew', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Singapore General Hospital, Singapore.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Low', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
998,31435581,Corifollitropin-  α  compared to daily r-FSH in for patients undergoing intracytoplasmic sperm injection: Clinical trial study.,"Background


The current treatment regimen for ovarian stimulation in Intracytoplasmic sperm injection (ICSI) patients is daily injections of Gonadotropins. Recombinant DNA technologies have produced a new recombinant molecule that is a long-acting Follicle Stimulating Hormone (FSH), named corifollitropin alfa. A single injection of long-acting FSH can replace seven daily FSH injections during the first week of controlled ovarian stimulation (COS) and can make assisted reproduction more patients-friendly. There is limited data with different results in this area.
Objective


To compare the effectiveness of long-acting FSH vs. daily r-FSH in terms of pregnancy and safety outcomes in women undergoing ICSI cycles.
Materials and Methods


In this clinical trial study, 109 women who were the candidates for ICSI at azzahra hospital were divided in two groups. The first group received 150 units of daily Gonal-f from second or third day of menstruation. The second group received a 150IU corifollitropin alfa on the second or third day of mensuration, and the treatment continued from day eighth of stimulation with Gonal-f based on the ultrasound finding. Both the groups received GnRH antagonist from fifth day of stimulation. Two groups were compared in terms of number of dominant follicles, number of oocytes, stimulation duration, total number of embryos, number of transferred embryos, and success rate of pregnancy.
Results


No significant difference was found between the two groups in terms of stimulation duration, number of follicles, number of oocytes, total number of embryos, and number of transferred embryos. Moreover, pregnancy outcomes including chemical pregnancy rate (positive pregnancy test), clinical pregnancy rate (detection of fetal heart), the rate of ovarian hyper-stimulation syndrome, multiple-pregnancy, ectopic pregnancy, and miscarriage didn't have a significant difference between the two groups.
Conclusion


As corifollitropin alfa was as effective as r-FSH, it could be used as an alternative to ovulation stimulation method in patients undergoing ICSI.",2019,"No significant difference was found between the two groups in terms of stimulation duration, number of follicles, number of oocytes, total number of embryos, and number of transferred embryos.","['patients undergoing ICSI', 'women undergoing ICSI cycles', 'patients undergoing intracytoplasmic sperm injection', '109 women who were the candidates for ICSI at azzahra hospital were divided in two groups']","['long-acting FSH vs. daily r-FSH', 'GnRH antagonist', 'Corifollitropin', 'α  compared to daily r-FSH', 'corifollitropin alfa', 'Recombinant DNA technologies', '150IU corifollitropin alfa']","['stimulation duration, number of follicles, number of oocytes, total number of embryos, and number of transferred embryos', 'number of dominant follicles, number of oocytes, stimulation duration, total number of embryos, number of transferred embryos, and success rate of pregnancy', 'chemical pregnancy rate (positive pregnancy test), clinical pregnancy rate (detection of fetal heart), the rate of ovarian hyper-stimulation syndrome, multiple-pregnancy, ectopic pregnancy, and miscarriage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C2713522', 'cui_str': 'Corifollitropin alfa product'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0015935', 'cui_str': 'Fetal Heart'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",109.0,0.0806574,"No significant difference was found between the two groups in terms of stimulation duration, number of follicles, number of oocytes, total number of embryos, and number of transferred embryos.","[{'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Zahiri Sorouri', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics & Gynecology, Al-zahra Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Davoud', 'Initials': 'D', 'LastName': 'Pourmarzi', 'Affiliation': 'Epidemiology, Reproductive Health Research Center, Gilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Safar Khah', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics & Gynecology, Al-zahra Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i1.3817']
999,8923992,The impact of laparoscopic cholecystectomy on the practice and training of gallbladder surgery in Thailand.,"The objective of this study was to find out the impact laparoscopic cholecystectomy had on the practice and training of cholecystectomy in Thailand. This study involved prospective interviewing by questionnaires, of patients who had had cholecystectomies by laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) techniques starting from their immediate postoperative days, comparison of the length of hospital stay and the costs of LC and OC, and the surveillance of Thai laparoscopic surgeons' experience and surgical residents' attitude towards this procedure. The results revealed that laparoscopic surgeons offered LC to most of their patients with gallstones but in each institution the proportion of cholecystectomies performed was below 70%. Patients' satisfaction was higher and postoperative pain was less after LC. Complications occurred in 2.12% (37 in 1744 patients). The length of hospital stay was slightly shorter (2.68 +/- 0.62 versus 3.30 +/- 0.95 days) and the expenses were only slightly higher for LC. Most residents were interested to learn this procedure only after they have finished their formal surgical training; they still felt that LC was suitable only for patients with a higher economic status and that it was associated with a higher complication rate. This study suggest that LC did have an impact on the practice of cholecystectomy and future planning of trainings should take into account the necessity to change residents' misunderstanding about the suitability of this procedure in appropriate patients.",1996,Patients' satisfaction was higher and postoperative pain was less after LC.,"['gallbladder surgery in Thailand', ""patients who had had cholecystectomies by laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) techniques starting from their immediate postoperative days, comparison of the length of hospital stay and the costs of LC and OC, and the surveillance of Thai laparoscopic surgeons' experience and surgical residents' attitude towards this procedure""]","['laparoscopic cholecystectomy', 'LC']","['length of hospital stay', 'complication rate', 'postoperative pain', 'Complications']","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C3875150', 'cui_str': 'Towards'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",1744.0,0.0186714,Patients' satisfaction was higher and postoperative pain was less after LC.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pongchairerks', 'Affiliation': 'Department of Surgery, Ramathibodi Hospital, Mahidol University, Thailand.'}]","Annals of the Academy of Medicine, Singapore",[]
1000,9055014,Topical squaric acid dibutylester therapy for alopecia areata: a double-sided patient-controlled study.,"In this prospective, double-sided patient-controlled therapeutical trial involving 20 patients with alopecia areata, we investigated the efficacy of topical acid dibutylester (SADBE) in the treatment of alopecia areata. Sensitisation was achieved with 2% SADBE in acetone followed by weekly application of topical SADBE to designated alopecia sites for 20 weeks. Untreated alopecia sites on the same patient acted as controls. Nineteen of the twenty patients completed 20 weeks of treatment. On the SADBE treated sites, excellent response (> 75% hair regrowth) was observed in 68% (13/19) of patients at the end of 20 weeks of treatment. On the untreated control sites, the corresponding figure was 11% (2/19). The difference in response between SADBE treated and untreated sites was statistically significant (P < 0.001). Mean onset of hair regrowth was 6 weeks after starting treatment. Patients with duration of alopecia 12 months or longer fared poorer compared with patients with a shorter duration of the disease. The extent of involvement did not appear to influence treatment outcome. Side effects were mainly local and were mainly local and were well tolerated. At 6 months follow-up, 33% (2/6) of responders with alopecia totalis relapsed compared to 11% (19) of those with patchy alopecia areata. We conclude that topical immunotherapy with SADBE is effective in inducing hair regrowth in alopecia areata.",1996,The difference in response between SADBE treated and untreated sites was statistically significant (P < 0.001).,"['alopecia areata', '20 patients with alopecia areata']","['topical acid dibutylester (SADBE', 'Topical squaric acid dibutylester therapy']","['tolerated', 'Mean onset of hair regrowth']","[{'cui': 'C0002171', 'cui_str': 'Alopecia Circumscripta'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0075093', 'cui_str': 'SADBE'}, {'cui': 'C0075092', 'cui_str': 'squaric acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}]",20.0,0.0210304,The difference in response between SADBE treated and untreated sites was statistically significant (P < 0.001).,"[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Chua', 'Affiliation': 'National Skin Centre, Singapore.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Goh', 'Affiliation': ''}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Ang', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1001,8900242,Association of the insulin-receptor variant Met-985 with hyperglycemia and non-insulin-dependent diabetes mellitus in the Netherlands: a population-based study.,"One of the characteristics of non-insulin-dependent diabetes mellitus (NIDDM) is the presence of insulin resistance. Most NIDDM patients have a normal sequence of the insulin receptor, indicating that, if insulin-receptor mutations contribute to the development of NIDDM, they will be present only in a minor fraction of the NIDDM population. The goal of the present study was to examine whether insulin-receptor mutations contribute to the development of NIDDM. We examined 161 individuals with NIDDM and 538 healthy controls from the population-based Rotterdam study for the presence of mutations in the insulin-receptor gene by SSCP. A heterozygous mutation changing valine-985 into methionine was detected in 5.6% of diabetic subjects and in 1.3% of individuals with normal oral glucose tolerance test. Adjusted for age, gender, and body-mass index, this revealed a relative risk for diabetes of 4.49 (95% confidence interval 1.59-12.25) for Met-985 carriers. When the total study group was analyzed, the prevalence of the mutation increased with increasing serum glucose levels (test for trend P < .005). We conclude that the Met-985 insulin-receptor variant associates with hyperglycemia and represents a risk factor for NIDDM.",1996,"When the total study group was analyzed, the prevalence of the mutation increased with increasing serum glucose levels (test for trend P < .005).",['161 individuals with NIDDM and 538 healthy controls from the population-based Rotterdam study for the presence of mutations in the insulin-receptor gene by SSCP'],['insulin-receptor variant Met-985 with hyperglycemia and non-insulin'],['serum glucose levels'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0034818', 'cui_str': 'Insulin Receptor'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0243031', 'cui_str': 'SSCP'}]","[{'cui': 'C0034818', 'cui_str': 'Insulin Receptor'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0337525,"When the total study group was analyzed, the prevalence of the mutation increased with increasing serum glucose levels (test for trend P < .005).","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Hart', 'Affiliation': 'Department of Medical Biochemistry, Sylvius Laboratories, Leiden University.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Stolk', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Heine', 'Affiliation': ''}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': ''}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'van der Does', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Maassen', 'Affiliation': ''}]",American journal of human genetics,[]
1002,8579313,A randomised single institution study comparing laser prostatectomy and transurethral resection of the prostate.,"We concluded a prospective randomised study comparing conventional electrocautery transurethral resection of the prostate (TURP) to laser prostatectomy using a right-angled Nd:YAG beam reflector. Seventy-one patients were evaluable, 34 laser and 37 TURP. Fifty patients have completed 6 months of follow-up. Using standard post prostatectomy outcome parameters of maximum flow rate and post void residual urine, laser prostatectomy shows equivalence at 6 months, with mean maximum flow rates of 8.76 ml/sec preoperatively improving to 15.47 ml/sec at 6 months, whilst for TURP patients, flow rates improved from a mean of 9.48 ml/sec preoperatively to 19.1 ml/sec at 6 months. Symptom scores remain higher for the laser patients at this time with a mean score of 9.27 compared to 4.43 for TURP patients. However, morbidity in the laser group is less, particularly given the absence of postoperative bleeding and the necessity for blood transfusion.",1995,"However, morbidity in the laser group is less, particularly given the absence of postoperative bleeding and the necessity for blood transfusion.","['Fifty patients have completed 6 months of follow-up', 'Seventy-one patients were evaluable, 34 laser and 37 TURP']","['laser prostatectomy and transurethral resection of the prostate', 'conventional electrocautery transurethral resection of the prostate (TURP) to laser prostatectomy using a right-angled Nd:YAG beam reflector']","['maximum flow rate and post void residual urine, laser prostatectomy shows equivalence', 'flow rates', 'morbidity', 'mean maximum flow rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0860124', 'cui_str': 'Laser prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0860124', 'cui_str': 'Laser prostatectomy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",71.0,0.0265049,"However, morbidity in the laser group is less, particularly given the absence of postoperative bleeding and the necessity for blood transfusion.","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Costello', 'Affiliation': ""Department of Urology, St Vincent's Hospital, Melbourne, Fitzroy Vic, Australia.""}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Crowe', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Street', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1003,31337647,Uptake of Cervical Cancer Screening in Ethiopia by Self-Sampling HPV DNA Compared to Visual Inspection with Acetic Acid: A Cluster Randomized Trial.,"In Ethiopia, the standard method of cervical cancer screening is using Visual Inspection with Acetic Acid (VIA). Self-collection-based human papillomavirus (HPV) testing is assumed to improve the uptake of screening, especially for hard to reach populations. We investigated whether HPV DNA testing with the self-collection of cervical samples would be associated with increased uptake and adherence to procedures at the population level compared with VIA within defined rural population in Ethiopia. A total of 22 clusters (comprising 2,356 women ages 30-49 years) were randomized in two arms. Following the community mobilization, women of the clusters were invited to go either to the local health post for a self-collection-based HPV DNA testing (arm A) or Butajira Hospital for VIA screening (arm B). In the HPV arm, of the 1,213 sensitized women, 1,020 (84.1%) accessed the health post for self-sampling compared with the VIA arm, where 575 of 1,143 (50.5%) visited the hospital for VIA ( P  < 0.0001). Of those women who attended the VIA and HPV arms, 40% and 65.4% adhered to all procedures expected after screening, respectively. Out of women positive for high risk HPV, 122 (85%) attended VIA as a follow-up test. The trial demonstrated significantly higher levels of population-based uptake and adherence for self-collection HPV testing. Women were more receptive for VIA after their HPV testing result was positive. Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.",2019,Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.,"['A total of 22 clusters (comprising 2,356 women ages 30-49 years']","['Acetic Acid', 'Acetic Acid (VIA', 'Self-collection-based human papillomavirus (HPV) testing', 'local health post for a self-collection-based HPV DNA testing (arm A) or Butajira Hospital for VIA screening (arm B']","['levels of population-based uptake and adherence for self-collection HPV testing', 'health post for self-sampling']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",2356.0,0.197346,Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.,"[{'ForeName': 'Muluken', 'Initials': 'M', 'LastName': 'Gizaw', 'Affiliation': 'Addis Ababa University, School of Public Health, Department of Preventive Medicine, Ethiopia.'}, {'ForeName': 'Brhanu', 'Initials': 'B', 'LastName': 'Teka', 'Affiliation': 'Addis Ababa University, School of Medicine, Department of Microbiology, Immunology and Parasitology, Ethiopia.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Ruddies', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Tamrat', 'Initials': 'T', 'LastName': 'Abebe', 'Affiliation': 'Addis Ababa University, School of Medicine, Department of Microbiology, Immunology and Parasitology, Ethiopia.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Gynecology, Charité-Universitätmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Worku', 'Affiliation': 'Addis Ababa University, School of Public Health, Department of Preventive Medicine, Ethiopia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wienke', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Ahmedin', 'Initials': 'A', 'LastName': 'Jemal', 'Affiliation': 'Department of Intramural Research, American Cancer Society, Atlanta, Georgia.'}, {'ForeName': 'Adamu', 'Initials': 'A', 'LastName': 'Addissie', 'Affiliation': 'Addis Ababa University, School of Public Health, Department of Preventive Medicine, Ethiopia.'}, {'ForeName': 'Eva Johanna', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics Martin-Luther-University, Halle-Wittenberg, Germany. eva.kantelhardt@uk-halle.de.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0156']
1004,30953467,Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone in patients with low-risk resectable colorectal liver metastases - the multicenter randomized controlled PUMP trial.,"BACKGROUND


Recurrences are reported in 70% of all patients after resection of colorectal liver metastases (CRLM), in which half are confined to the liver. Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy aims to reduce the risk of intrahepatic recurrence. A large retrospective propensity score analysis demonstrated that HAIP chemotherapy is particularly effective in patients with low-risk oncological features. The aim of this randomized controlled trial (RCT) --the PUMP trial-- is to investigate the efficacy of adjuvant HAIP chemotherapy in low-risk patients with resectable CRLM.
METHODS


This is an open label multicenter RCT. A total of 230 patients with resectable CRLM without extrahepatic disease will be included. Only patients with a clinical risk score (CRS) of 0 to 2 are eligible, meaning: patients are allowed to have no more than two out of five poor prognostic factors (disease-free interval less than 12 months, node-positive colorectal cancer, more than 1 CRLM, largest CRLM more than 5 cm in diameter, serum Carcinoembryonic Antigen above 200 μg/L). Patients randomized to arm A undergo complete resection of CRLM without any adjuvant treatment, which is the standard of care in the Netherlands. Patients in arm B receive an implantable pump at the time of CRLM resection and start adjuvant HAIP chemotherapy 4-12 weeks after surgery, with 6 cycles of floxuridine scheduled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival, hepatic PFS, safety, quality of life, and cost-effectiveness. Pharmacokinetics of intra-arterial administration of floxuridine will be investigated as well as predictive biomarkers for the efficacy of HAIP chemotherapy. In a side study, the accuracy of CT angiography will be compared to radionuclide scintigraphy to detect extrahepatic perfusion. We hypothesize that adjuvant HAIP chemotherapy leads to improved survival, improved quality of life, and a reduction of costs, compared to resection alone.
DISCUSSION


If this PUMP trial demonstrates that adjuvant HAIP chemotherapy improves survival in low-risk patients, this treatment approach may be implemented in the standard of care of patients with resected CRLM since adjuvant systemic chemotherapy alone has not improved survival.
TRIAL REGISTRATION


The PUMP trial is registered in the Netherlands Trial Register (NTR), number: 7493 . Date of registration September 23, 2018.",2019,Pharmacokinetics of intra-arterial administration of floxuridine will be investigated as well as predictive biomarkers for the efficacy of HAIP chemotherapy.,"['patients with low-risk resectable colorectal liver metastases', 'Only patients with a clinical risk score (CRS) of 0 to 2 are eligible, meaning: patients', 'low-risk patients with resectable CRLM', '230 patients with resectable CRLM without extrahepatic disease will be included', 'low-risk patients', 'patients with low-risk oncological features']","['CT angiography', 'Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone', 'HAIP chemotherapy', 'CRLM', 'adjuvant HAIP chemotherapy', 'floxuridine', 'implantable pump at the time of CRLM resection and start adjuvant HAIP chemotherapy', 'Adjuvant hepatic arterial infusion pump', 'HAIP) chemotherapy']","['overall survival, hepatic PFS, safety, quality of life, and cost-effectiveness', 'progression-free survival (PFS', 'survival', 'survival, improved quality of life', 'risk of intrahepatic recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0021436', 'cui_str': 'Perfusion Pumps'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0016343', 'cui_str': 'Floxuridine'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",230.0,0.270171,Pharmacokinetics of intra-arterial administration of floxuridine will be investigated as well as predictive biomarkers for the efficacy of HAIP chemotherapy.,"[{'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Buisman', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Erasmus University, Dr. Molewaterplein 40, 3015, GD, Rotterdam, The Netherlands. f.buisman@erasmusmc.nl.'}, {'ForeName': 'M Y V', 'Initials': 'MYV', 'LastName': 'Homs', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Grünhagen', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Erasmus University, Dr. Molewaterplein 40, 3015, GD, Rotterdam, The Netherlands.'}, {'ForeName': 'W F', 'Initials': 'WF', 'LastName': 'Filipe', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Erasmus University, Dr. Molewaterplein 40, 3015, GD, Rotterdam, The Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Bennink', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'M G H', 'Initials': 'MGH', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'I H M', 'Initials': 'IHM', 'LastName': 'Borel Rinkes', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'R C G', 'Initials': 'RCG', 'LastName': 'Bruijnen', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cercek', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': ""D'Angelica"", 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'van Delden', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Donswijk', 'Affiliation': 'Department of Nuclear Medicine, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van Doorn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Doornebosch', 'Affiliation': 'Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Emmering', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Erdmann', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'IJzerman', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grootscholten', 'Affiliation': 'Department of Medical Oncology, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hagendoorn', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Kemeny', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Kingham', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Klompenhouwer', 'Affiliation': 'Department of Radiology, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'N F M', 'Initials': 'NFM', 'LastName': 'Kok', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'K F D', 'Initials': 'KFD', 'LastName': 'Kuhlmann', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Kuiper', 'Affiliation': 'Department of Medical Oncology, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'M G E', 'Initials': 'MGE', 'LastName': 'Lam', 'Affiliation': 'Department of Nuclear Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'R H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moelker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'C J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Te Riele', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'J M L', 'Initials': 'JML', 'LastName': 'Roodhart', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Swijnenburg', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Prevoo', 'Affiliation': 'Department of Radiology, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Tanis', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vermaas', 'Affiliation': 'Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'M W J', 'Initials': 'MWJ', 'LastName': 'Versleijen', 'Affiliation': 'Department of Nuclear Medicine, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Veuger', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Weterman', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Erasmus University, Dr. Molewaterplein 40, 3015, GD, Rotterdam, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Groot Koerkamp', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Erasmus University, Dr. Molewaterplein 40, 3015, GD, Rotterdam, The Netherlands.'}]",BMC cancer,['10.1186/s12885-019-5515-6']
1005,8849179,Comparing the efficacy of pefloxacin and ciprofloxacin in the treatment of acute uncomplicated gonococcal urethritis in males.,"The aim of this study was to compare the efficacy of single-dose pefloxacin 400 mg and ciprofloxacin 250 mg in the treatment of acute uncomplicated gonococcal urethritis in males. One hundred and twenty male patients with uncomplicated gonococcal urethritis were assigned alternately to receive single oral doses of either pefloxacin 400 mg or ciprofloxacin 250 mg. Forty-one out of 43 patients (95.3%) of the pefloxacin group and 46 of 47 (97.9%) of the ciprofloxacin group were cured of gonorrhoeae. The rates of post-gonococcal urethritis were 57.7% and 53.3% in the pefloxacin and ciprofloxacin groups respectively. There was a high incidence of penicillinase-producing gonococci (34.2%). High level resistance to pefloxacin (minimum inhibitory concentration [MIC] >1.0 mg/l) resulting in clinical failure on 400 mg stat dose was noted in 1 isolate. It also showed decreased susceptibility to ciprofloxacin (MIC 0.25 mg/l). Another isolate showed high-level resistance (MIC 0.06 mg/l) to ciprofloxacin 250 mg stat dose with concomitant decreased susceptibility to pefloxacin (MIC >1.0 mg/l). Ciprofloxacin 250 mg stat dose is still useful for the treatment of uncomplicated gonococcal urethritis in males. The cure rate of 95.3% with pefloxacin at 400 mg stat dose is acceptable, but needs to be monitored with caution. The emergence of a more resistant strain of Neisseria gonorrhoeae to fluoroquinolones calls for vigilance in the monitoring of antimicrobial susceptibility.",1995,The rates of post-gonococcal urethritis were 57.7% and 53.3% in the pefloxacin and ciprofloxacin groups respectively.,"['One hundred and twenty male patients with uncomplicated gonococcal urethritis', 'uncomplicated gonococcal urethritis in males', 'acute uncomplicated gonococcal urethritis in males']","['pefloxacin', 'Ciprofloxacin', 'pefloxacin and ciprofloxacin', 'pefloxacin (minimum inhibitory concentration [MIC', 'ciprofloxacin', 'pefloxacin 400 mg or ciprofloxacin']","['high-level resistance', 'cured of gonorrhoeae', 'rates of post-gonococcal urethritis', 'cure rate']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018078', 'cui_str': 'Gonococcal urethritis (disorder)'}]","[{'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877646', 'cui_str': 'Post gonococcal urethritis'}]",120.0,0.0384801,The rates of post-gonococcal urethritis were 57.7% and 53.3% in the pefloxacin and ciprofloxacin groups respectively.,"[{'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Leow', 'Affiliation': 'National Skin Centre, Singapore.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Cheong', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Goh', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nadarajah', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1006,8849180,Dual therapy with doxycycline and ketoprofen compared to doxycycline in the treatment of uncomplicated non-gonococcal urethritis.,"The aim of this study was to compare a combination of doxycyline and ketoprofen, and doxycycline alone in treating non-gonococcal urethritis (NGU), with particular emphasis on reducing recurrent or persistent disease. Sixty-five men with first episode acute NGU were enrolled between November 1992 and November 1994. The men were randomly assigned to either the doxycycline plus ketoprofen group, group A (doxycycline 100 mg twice daily for 10 days plus ketoprofen 200 mg daily for 10 days, n = 34), or the doxycycline group, group B (100 mg twice daily for 10 days, n = 31). Out of the 65 patients studied, Chlamydia trachomatis was isolated from 9 patients (13.8%), Ureaplasma urealyticum from 6 patients (9.2%) and Mycoplasma hominis from 2 patients (3.1%). At 6 weeks in group A, 16 patients (47%) were cured, one patient had a recurrence (2.9%), and 4 patients had persistent infection (11.8%). Eleven patients defaulted follow-up (32.4%) and 2 patients were dropped from the trial. In contrast, for group B, 13 patients (42%) were cured, 5 patients (16%) had a recurrence, 2 patients (6.5%) had persistent infection and 3 patients (9.7%) were reinfected. Eight patients (25.8%) defaulted follow-up. At 12 weeks, for group A, 14 patients (41.2%) remained cured, one patient (2.9%) had a recurrence, 4 patients (11.8%) had persistent infection and one patient (2.9%) was reinfected. Twelve patients (35.3%) defaulted follow-up. For group B, 8 patients (25.8%) remained cured, 6 patients (19.4%) had recurrence, 2 patients (6.5%) had persistent infection and 5 patients (16.1%) were reinfected. Ten patients (32.2%) defaulted follow-up. There were no statistically significant differences between the two groups except for patients with recurrent NGU where the difference (1 versus 6 patients) was statistically significant (P = 0.019).",1995,"Out of the 65 patients studied, Chlamydia trachomatis was isolated from 9 patients (13.8%), Ureaplasma urealyticum from 6 patients (9.2%) and Mycoplasma hominis from 2 patients (3.1%).","['Sixty-five men with first episode acute NGU were enrolled between November 1992 and November 1994', 'uncomplicated non-gonococcal urethritis']","['doxycycline', 'ketoprofen', 'doxycycline alone', 'doxycycline plus ketoprofen', 'doxycycline and ketoprofen', 'doxycyline and ketoprofen']","['persistent infection', 'Chlamydia trachomatis', 'recurrence', 'Ureaplasma urealyticum']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C1112709', 'cui_str': 'Nongonococcal urethritis (disorder)'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0085501', 'cui_str': 'Ureaplasma urealyticum biovar 2'}]",65.0,0.0211633,"Out of the 65 patients studied, Chlamydia trachomatis was isolated from 9 patients (13.8%), Ureaplasma urealyticum from 6 patients (9.2%) and Mycoplasma hominis from 2 patients (3.1%).","[{'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Tay', 'Affiliation': 'National Skin Centre, Singapore.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Goh', 'Affiliation': ''}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Ling', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1007,8849185,Project youth inform--a school-based sexually transmitted disease/acquired immune deficiency syndrome education programme.,"A pilot project, ¿Youth Inform¿ endorsed by the Ministry of Health and Ministry of Education, Singapore, was undertaken in 1992 for 2 years. It aims to enhance sexually transmitted disease (STDs)/human immunodeficiency virus (HIV) control in Singapore by providing structured information for young people between the ages of 16 to 20 years in Polytechnics, Junior Colleges, Centralised Institutes and Pre-University Centres. Project Youth Inform comprises 8 components. They include a focus group discussion, a training seminar for teachers, a lecture/slide presentation cum question-and-answer session, an educational booklet/bookmark, exhibitions, a video, provisions for anonymous questions, and an evaluation. The programme is conducted during school hours at the premises of the institutions and the attendance per session is between 150 to 350 students. A total of 152 sessions have been completed for all the schools. It is ongoing and is currently administered by the School Health Service and Training and Health Education Department. Feedback from principals, teachers and students was gathered formally through surveys and informally through interviews and observations. One thousand students were randomly selected for the survey to assess their responses towards the programme. Eighty-six percent reported that they found it educational and informative. Indicators found to have an influence on the effectiveness of the programme were timing, vocabulary used (medical terms) and integration of the programme into the school's curriculum. In conclusion, Project Youth Inform was on the whole positively received. However, it is essential to constantly accommodate and adapt to new facts and methods of teaching and maintain close coordination with the Ministries and the schools. An effective STD/acquired immune deficiency syndrome programme is an important step towards the prevention, management and control of the epidemic.",1995,"An effective STD/acquired immune deficiency syndrome programme is an important step towards the prevention, management and control of the epidemic.","['One thousand students', 'young people between the ages of 16 to 20 years in Polytechnics, Junior Colleges, Centralised Institutes and Pre-University Centres']","['training seminar for teachers, a lecture/slide presentation cum question-and-answer session, an educational booklet/bookmark, exhibitions, a video, provisions for anonymous questions, and an evaluation']",[],"[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557813', 'cui_str': 'Polytechnic (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0600649', 'cui_str': 'Exhibitions'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",[],1000.0,0.0188441,"An effective STD/acquired immune deficiency syndrome programme is an important step towards the prevention, management and control of the epidemic.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Soon', 'Affiliation': 'Department of STD Control, National Skin Centre, Singapore.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Goh', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1008,8849189,Bacillus Calmette-Guerin (BCG) in the treatment of superficial bladder cancer.,"We evaluated the efficacy of immune and scarification Bacillus Calmette-Guerin (BCG) in the treatment of carcinoma in situ and prophylaxis against recurrence in patients with superficial transitional carcinoma of the bladder. A single-blind, randomised, comparative trial involving 43 patients with a median follow-up of 39 months was analysed. The end points were progression to muscle invasive disease or recurrence. The overall response rate was 93% after one to two courses. There was no difference between the two preparations and no statistically significant difference between the response or progression rates of the carcinoma in-situ or prophylactic groups. However, the response to BCG was found to be a significant prognostic indicator in a multivariate analysis.",1995,There was no difference between the two preparations and no statistically significant difference between the response or progression rates of the carcinoma in-situ or prophylactic groups.,"['superficial bladder cancer', '43 patients with a median follow-up of 39 months was analysed', 'patients with superficial transitional carcinoma of the bladder']","['immune and scarification Bacillus Calmette-Guerin (BCG', 'Bacillus Calmette-Guerin (BCG']","['response or progression rates', 'progression to muscle invasive disease or recurrence', 'overall response rate']","[{'cui': 'C1336527', 'cui_str': 'Superficial bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0184907', 'cui_str': 'Scarification (procedure)'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0085957', 'cui_str': 'BCG'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",43.0,0.0551442,There was no difference between the two preparations and no statistically significant difference between the response or progression rates of the carcinoma in-situ or prophylactic groups.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': 'Department of Urology, Singapore General Hospital, Singapore.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Consigliere', 'Affiliation': ''}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Foo', 'Affiliation': ''}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Tung', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Tock', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1009,32437703,"Reactions to graphic and text health warnings for cigarettes, sugar-sweetened beverages, and alcohol: An online randomized experiment of US adults.","We aimed to examine reactions to graphic versus text-only warnings for cigarettes, SSBs, and alcohol. A convenience sample of US adults completed an online survey in 2018 (n = 1352 in the analytic sample). We randomly assigned participants to view a: 1) text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information. Participants viewed their assigned warning on cigarettes, SSBs, and alcohol, in a random order. Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ. Compared to SSB and alcohol warnings, cigarette warnings led to higher perceived message effectiveness, believability, fear, thinking about harms, policy support, and greater reductions in product appeal (all p < .05). The efficacy information did not influence any outcomes. Graphic warnings out-performed text-only warnings on key predictors of behavior despite causing more reactance.",2020,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","['A convenience sample of US adults completed an online survey in 2018 (n\u202f=\u202f1352 in the analytic sample', 'cigarettes, sugar-sweetened beverages, and alcohol', 'US adults']","[""text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information""]","['message effectiveness, believability, fear, thinking about harms, policy support', 'lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0359166,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","[{'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: mghall@unc.edu.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Population and Development Studies, Harvard TH Chan School of Public Health, Cambridge, MA, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Maynard', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK; MRC Integrative Epidemiology Unit (IEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106120']
1010,31425700,"Effects of macular xanthophyll supplementation on brain-derived neurotrophic factor, pro-inflammatory cytokines, and cognitive performance.","PURPOSE


Oxidative and inflammatory processes play a major role in stress-induced neural atrophy. There is a wide body of literature linking oxidative and inflammatory stress with reductions in neurotrophic factors, stress resilience, and cognitive function. Based on their antioxidant and anti-inflammatory capacity, we investigated the effect of the dietary carotenoids lutein and zeaxanthin, along with the zeaxanthin isomer meso-zeaxanthin (collectively the ""macular xanthophylls"" [MXans]) on systemic brain-derived neurotrophic factor (BDNF) and anti-oxidant capacity (AOC), and the pro-inflammatory cytokines TNF-α, IL-6, and IL-1β. To investigate higher-order effects, we assessed cognitive performance.
METHODS


59 young (18-25 yrs.), healthy subjects participated in a 6-month, double-blind, placebo-controlled trial to evaluate the effects of MXan supplementation on the aforementioned serum parameters and cognitive performance. Subjects were randomly assigned to one of three groups: placebo, 13 mg, or 27 mg/day total MXans; all measures were taken at baseline and 6 months. Blood was obtained via fasting blood draw, and MXan concentration in the retina (termed macular pigment optical density [MPOD]) was measured via customized heterochromatic flicker photometry. Serum BDNF and cytokines were assessed via ELISA. Serum antioxidant capacity (AOC) and serum MXan concentrations were quantified via colorimetric microplate assay, and high-performance liquid chromatography, respectively. Cognitive performance was measured via a computer-based assessment tool (CNS Vital Signs).
RESULTS


BDNF, MPOD, serum MXans, and AOC all increased significantly versus placebo in both treatment groups over the 6-month study period (p < .05 for all). IL-1β decreased significantly versus placebo in both treatment groups (p = .0036 and p = .006, respectively). For cognitive measures, scores for composite memory, verbal memory, sustained attention, psychomotor speed, and processing speed all improved significantly in treatment groups (p < .05 for all) and remained unchanged in the placebo group. Several measures were found to be significantly associated in terms of relational changes over the course of the study. Notably, change in BDNF was related to change in IL-1β (r = -0.47; p < .001) and MPOD (r = 0.44; p = .0086). Additionally, changes in serum MXans were strongly related to AOC (r = 0.79 & 0.61 for lutein and zeaxanthin isomers respectively; p < .001). For cognitive scores, change in BDNF was correlated to change in composite memory (r = 0.32; p = .014) and verbal memory (r = 0.35; p = .007), whereas change in MPOD was correlated with change in both psychomotor speed (r = 0.38; p = .003), and processing speed (r = 0.35; p = .007). Change in serum lutein was found to be significantly correlated to change in verbal memory (r = 0.41; p < .001), composite memory (r = 0.31; p = .009), and sustained attention (r = 0.28; p = .036). Change in serum zeaxanthin isomers was significantly correlated with change in verbal memory (r = 0.33; p = .017). Lastly, change in AOC was significantly associated with verbal memory (r = 0.34; p = .021), composite memory (r = 0.29; p = .03), and sustained attention (r = 0.35; p = .016). No significant relational changes in any cognitive parameter were found for the placebo group.
CONCLUSIONS


Six months of daily supplementation with at least 13 mg of MXans significantly reduces serum IL-1β, significantly increases serum MXans, BDNF, MPOD, and AOC, and improves several parameters of cognitive performance. Findings suggest that increased systemic antioxidant/anti-inflammatory capacity (and not necessarily deposition of the carotenoids in neural tissues), may explain many of the effects determined in this study. The significant relationship between change in BDNF and IL-1β over the course of the study suggests that regular consumption of MXans interrupts the inflammatory cascade that can lead to reduction of BDNF. Changes in MPOD and BDNF appear to account for enhancement in cognitive parameters that involve speed of processing and complex processing, respectively. ISRCTN Clinical Trial Registration: ISRCTN16156382.",2019,"IL-1β decreased significantly versus placebo in both treatment groups (p = .0036 and p = .006, respectively).","['59 young (18-25\u202fyrs', 'healthy subjects']","['dietary carotenoids lutein and zeaxanthin, along with the zeaxanthin isomer meso-zeaxanthin', 'placebo', 'MXan supplementation', 'macular xanthophyll supplementation']","['brain-derived neurotrophic factor, pro-inflammatory cytokines, and cognitive performance', 'Serum antioxidant capacity (AOC) and serum MXan concentrations', 'Change in serum zeaxanthin isomers', 'serum MXans, BDNF, MPOD, and AOC, and improves several parameters of cognitive performance', 'For cognitive measures, scores for composite memory, verbal memory, sustained attention, psychomotor speed, and processing speed', 'verbal memory', 'Lastly, change in AOC', 'Serum BDNF and cytokines', 'change in MPOD', 'BDNF, MPOD, serum MXans, and AOC', 'Change in serum lutein', 'systemic antioxidant/anti-inflammatory capacity', 'changes in serum MXans', 'IL-1β', 'relational changes', 'cognitive scores, change in BDNF', 'serum IL-1β', 'MPOD', 'processing speed', 'composite memory', 'Cognitive performance', 'sustained attention']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C3884591', 'cui_str': 'meso-zeaxanthin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0949636', 'cui_str': 'Xanthophyll Carotenoids'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",59.0,0.154188,"IL-1β decreased significantly versus placebo in both treatment groups (p = .0036 and p = .006, respectively).","[{'ForeName': 'Nicole T', 'Initials': 'NT', 'LastName': 'Stringham', 'Affiliation': 'Interdisciplinary Neuroscience Program-Biomedical and Health Sciences Institute, University of Georgia, Athens, GA 30602, United States of America; Department of Psychology, University of Georgia, Athens, GA 30602, United States of America. Electronic address: nicole.stringham@duke.edu.'}, {'ForeName': 'Philip V', 'Initials': 'PV', 'LastName': 'Holmes', 'Affiliation': 'Interdisciplinary Neuroscience Program-Biomedical and Health Sciences Institute, University of Georgia, Athens, GA 30602, United States of America; Department of Psychology, University of Georgia, Athens, GA 30602, United States of America. Electronic address: pvholmes@uga.edu.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Stringham', 'Affiliation': 'Visual Performance Laboratory, Duke Eye Center, Durham, NC 27705, United States of America. Electronic address: james.stringham@duke.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112650']
1011,30508132,Predicting organizational readiness to implement HIV prevention with couples using practitioners' intentions: testing a heuristic.,"Couple-based interventions may play a key role in ending the AIDS epidemic. Progress has been made in demonstrating successful implementation of both manual-based and web-based modalities of couple-based HIV prevention in clinical trials. To ensure real world implementation, however, we need a better understanding of how best to prepare organizations to support such interventions. We sought to examine which domains of staff-reported organizational readiness predicted providers' intention to deliver a couple-based HIV-prevention intervention. Organizational readiness was assessed at baseline from 253 facilitators enrolled in a randomized clinical trial testing dissemination and implementation of a couple-based HIV prevention program (2007-2012). Consistent with current organizational-readiness theory, we measured general capacities; capacities specific to a couple-based intervention; and staff motivation to implement the intervention. We used multilevel regression models to examine the influence of these capacities on intention to implement at 6-, 12-, and 18-month follow-up, adjusting for staff age, education, role, years of service, and randomized condition. Higher perceived organizational resources (B = 0.126, p = .028) and better staff motivation (B = 0.510, p = .009) were significant predictors of increased intention to facilitate Connect. Higher organizational resource availability and stronger motivation to facilitate the intervention are key domains that could inform administrator and staff training to strengthen readiness for couple-based programs. However, further research is needed to clarify the role of these domains regarding actual implementation.",2020,"Higher perceived organizational resources (B = 0.126, p = .028) and better staff motivation (B = 0.510, p = .009) were significant predictors of increased intention to facilitate Connect.",[],['couple-based HIV prevention program'],"['organizational resources', 'Organizational readiness', 'better staff motivation']",[],"[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.040838,"Higher perceived organizational resources (B = 0.126, p = .028) and better staff motivation (B = 0.510, p = .009) were significant predictors of increased intention to facilitate Connect.","[{'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work, New York, NY, USA.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby121']
1012,8185271,A study on the usefulness of local anaesthesia for the laser vaporization of conizations in the uterine cervix.,"The purpose of our study is to evaluate the need to use anaesthesia during laser ablation treatment of cervical intraepithelial neoplasia (CIN) in populations of Asian women. Forty patients who were to undergo the ablation of CIN grade 1 or 2 were randomly divided into two groups. One group of patients was treated without any anaesthesia and the other group was treated using a paracervical block with lidocaine. The patients' experience of pain during the procedure was measured. These evaluations included an objective assessment made by the surgeons during the procedure using an objective pain scoring system, and a subjective estimation made by the patients themselves after the procedure using a visual analogue scale. Patients' feelings concerning the acceptability of either procedure were also elicited. Our results show that the case distribution of objective pain scores between the two groups of patients is not statistically different (p > 0.05). The mean visual analogue score of the patients who were not given anaesthesia (24.1%, SD 9.4) does not differ statistically from that of the patients who were administered a paracervical block (25.0%, SD 10.0, p > 0.05). Further, the acceptability rates of both groups are high (85% with paracervical block, 90% without anaesthesia), and the overall rates of the two groups are not statistically different (p > 0.05). These results imply that there may be differences in pain perception between Eastern and Western women. We conclude that in populations of Asian women, it is unnecessary to use anaesthesia during cervical laser ablation.",1994,"The mean visual analogue score of the patients who were not given anaesthesia (24.1%, SD 9.4) does not differ statistically from that of the patients who were administered a paracervical block (25.0%, SD 10.0, p > 0.05).","['uterine cervix', 'populations of Asian women', 'cervical intraepithelial neoplasia (CIN) in populations of Asian women', 'Forty patients who were to undergo the ablation of CIN grade 1 or 2']","['local anaesthesia', 'paracervical block with lidocaine', 'laser ablation treatment']","['mean visual analogue score', 'pain perception', 'objective pain scores', 'overall rates', 'acceptability rates']","[{'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0030401', 'cui_str': 'Paracervical Block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",90.0,0.0287144,"The mean visual analogue score of the patients who were not given anaesthesia (24.1%, SD 9.4) does not differ statistically from that of the patients who were administered a paracervical block (25.0%, SD 10.0, p > 0.05).","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynaecology, National Taiwan University Hospital, Taipei.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Chow', 'Affiliation': ''}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Huang', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1013,7741492,Randomised study comparing imipenem/cilastatin to ceftriaxone plus gentamicin in cancer chemotherapy-induced neutropenic fever.,"Prompt initiation of empiric antibiotic therapy is the cornerstone in the therapy of chemotherapy-induced neutropenic sepsis in cancer patients. Ceftriaxone plus gentamicin (ceftriaxone/gentamicin) is the most widely used combination of empiric antibiotics in the Department of Medical Oncology, Singapore General Hospital. However, imipenem/cilastatin has been shown to be a practical alternative. To compare the efficacy and cost effectiveness of monotherapy with our usual combination antibiotic therapy, 50 evaluable neutropenic cancer patients admitted for fever were randomised to empiric imipenem/cilastatin or ceftriaxone/gentamicin. Ceftriaxone/gentamicin was started in 24 patients. The initial clinical response rate to ceftriaxone/gentamicin was 62.5% and 84.6% to imipenem/cilastatin (P = 0.075). The average cost of antibiotics per patient started on ceftriaxone/gentamicin including cost of change of antibiotics was S$63 per day of antibiotic use and for imipenem/cilastatin it was S$252 (P < 0.02). In conclusion, although more patients receiving imipenem/cilastatin had an initial clinical response than those receiving ceftriaxone/gentamicin, this difference was not statistically significant. It would appear that imipenem/cilastatin is equivalent to ceftriaxone/gentamicin for the treatment of neutropenic sepsis. However, ceftriaxone/gentamicin was more cost effective.",1994,The initial clinical response rate to ceftriaxone/gentamicin was 62.5% and 84.6% to imipenem/cilastatin (P = 0.075).,"['50 evaluable neutropenic cancer patients admitted for fever', 'cancer chemotherapy-induced neutropenic fever', '24 patients', 'cancer patients']","['Ceftriaxone plus gentamicin (ceftriaxone/gentamicin', 'empiric antibiotic therapy', 'ceftriaxone plus gentamicin', 'imipenem/cilastatin', 'empiric imipenem/cilastatin or ceftriaxone/gentamicin', 'monotherapy', 'ceftriaxone/gentamicin', 'Ceftriaxone/gentamicin']","['initial clinical response', 'cost effective', 'average cost of antibiotics', 'cost of change of antibiotics', 'initial clinical response rate', 'efficacy and cost effectiveness']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0008777', 'cui_str': 'Cilastatin'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",50.0,0.0301571,The initial clinical response rate to ceftriaxone/gentamicin was 62.5% and 84.6% to imipenem/cilastatin (P = 0.075).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Au', 'Affiliation': 'Department of Medical Oncology, Singapore General Hospital.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tow', 'Affiliation': ''}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Ang', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1014,31417982,The effect of hormone replacement therapy on cognitive function in postmenopausal women: An RCT.,"Background


During the reproductive age, the human brain becomes a target for gonadal steroid hormones. Estrogens influence neural function through effects on neurons and affects indirectly the oxidative stress, inflammation, the cerebral vascular and the immune system.
Objective


To evaluate the effect of the traditional hormone replacement therapy (HRT) on the cognitive function in postmenopausal women.
Materials and Methods


In this randomized clinical trial, 140 postmenopausal women, from November 2014 to February 2015, were included. Women were randomly divided into two groups. Each woman in the case group took traditional HRT (0.625mg conjugated equine estrogens+2.5mg medroxyprogesterone acetate daily) plus one Cal+D tablet (500 mg calcium+200 IU vitamin D) daily for four months. Women in the control group received only one Cal+D tablet (500 mg calcium+200 IU vitamin D) daily for four months period. The Montreal Cognitive Assessment (MoCA) and Green Climacteric Scale (GCS) questionnaires filled out after the intervention and compared between the two groups.
Results


The mean points of the MoCA after the intervention indicate that all MoCA domains except for the orientation improved in the case group. There was a significant difference in the memory domain after the treatment between the two groups. MoCA domains and GCS were negatively correlated after the intervention (  r   =   -   0   .   235   ,   p   =   0   .   006    ).
Conclusion


The HRT has affected some of the MoCA factors. The effects of HRT on cognitive function should be studied in a large prospective study in a group of women in their early and late menopausal ages with periodic assessment of their cognitive function during these follow-up years.",2018,The mean points of the MoCA after the intervention indicate that all MoCA domains except for the orientation improved in the case group.,"['postmenopausal women', 'group of women in their early and late menopausal ages with periodic assessment of their cognitive function during these follow-up years', '235   ', '140 postmenopausal women, from November 2014 to February 2015, were included']","['Cal+D tablet', 'traditional HRT', 'traditional hormone replacement therapy (HRT', 'medroxyprogesterone acetate daily) plus one Cal+D tablet', 'hormone replacement therapy', 'HRT']","['MoCA domains and GCS', 'oxidative stress, inflammation, the cerebral vascular and the immune system', 'memory domain', 'Montreal Cognitive Assessment (MoCA) and Green Climacteric Scale (GCS) questionnaires', 'cognitive function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0020962', 'cui_str': 'Immune system'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C3496286'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",140.0,0.0445145,The mean points of the MoCA after the intervention indicate that all MoCA domains except for the orientation improved in the case group.,"[{'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Shahideh', 'Initials': 'S', 'LastName': 'Jahanian Sadatmahalleh', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Ziaei', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v16i12.3682']
1015,7847746,Effects of sleep deprivation on naval seamen: II. Short recovery sleep on performance.,"Twenty male naval volunteers, aged 18 to 20 years, with 12 to 14 years of education, underwent a total sleep deprivation experiment on board a Republic of Singapore Navy landing ship in the South China Sea for a period of 42-102 hours. The sleep group comprised eight volunteers who dropped out at the 44th-46th h of the experiment and were randomly assigned to a 2 or 4 h sleep regime. The rest served as sleep-deprived controls. Neurobehavioural performance tests, profile of mood state and the Stanford Sleepiness Scale were applied 6 hourly starting from 6.00 am on the first experimental day. No thresholds were observed in the performance of tests related to manual tasks and subjective feeling, including naval tasks, mood and sleepiness scale during the sleep deprivation experiment. However, thresholds were observed in the performance of tests requiring cognitive and perceptive skills, including the grooved peg board, trail making, sea-shore rhythm, addition, digit span, digit symbol, flicker fusion and dynamometer tests. Performances in these tests were observed to deteriorate only after approximately 30 h of sleep deprivation. The Z score for the non-threshold tests (Z-N) deteriorated from -0.01 at the start of the experiment to 1.25 at the 42nd h of the experiment just before the imposed sleep and improved to 0.81 at the 48th h of the experiment just after the imposed sleep; and the Z score for the threshold tests (Z-T) varied from -0.07 at the start to 0.49 just before sleep (at the 42nd h) and to continuously deteriorate to 0.83 just after sleep (at the 48th h).(ABSTRACT TRUNCATED AT 250 WORDS)",1994,"No thresholds were observed in the performance of tests related to manual tasks and subjective feeling, including naval tasks, mood and sleepiness scale during the sleep deprivation experiment.","['Twenty male naval volunteers, aged 18 to 20 years, with 12 to 14 years of education, underwent a total sleep deprivation experiment on board a Republic of Singapore Navy landing ship in the South China Sea for a period of 42-102 hours']",['sleep deprivation'],"['performance of tests related to manual tasks and subjective feeling, including naval tasks, mood and sleepiness scale', 'naval seamen', 'Neurobehavioural performance tests, profile of mood state and the Stanford Sleepiness Scale', 'grooved peg board, trail making, sea-shore rhythm, addition, digit span, digit symbol, flicker fusion and dynamometer tests']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C0036971', 'cui_str': 'Ships'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0016236', 'cui_str': 'Flicker Fusion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}]",,0.0127468,"No thresholds were observed in the performance of tests related to manual tasks and subjective feeling, including naval tasks, mood and sleepiness scale during the sleep deprivation experiment.","[{'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Foo', 'Affiliation': 'Department of Community, Occupational and Family Medicine, National University of Singapore.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'How', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Siew', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vijayan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kanapathy', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1016,7741493,Single-blind comparative analgesic and safety study of single doses of intramuscularly administered ketorolac tromethamine and pethidine hydrochloride in patients with pain following orthopaedic surgery.,"Ketorolac tromethamine, a potent non-narcotic prostaglandin synthetase inhibiting analgesic was compared with pethidine for relief of moderate to severe postoperative pain. Forty-eight patients received Ketorolac 0.5 mg/kg and 52 received pethidine 1.25 mg/kg. The degree of pain prior to the administration of the drug and pain relief that followed were quantified using a vertical visual analogue scale (VAS) and monitored at hourly intervals. The safety profile was also studied by recording all adverse events noted. The mean pain (VAS) score at medication for Ketorolac was 7.04 and for pethidine 7.09. The pain relief obtained in the first four hours following administration of the drugs was similar for pethidine and Ketorolac. Although Ketorolac showed a longer sustained pain relief, time to peak analgesia after administration of this drug was slower than that after pethidine. It took 30 to 50 min for pethidine compared to 75 to 150 min for Ketorolac to achieve peak analgesia. The latter is therefore inappropriate if rapid pain relief is required. The incidence of side effects was significantly greater with pethidine (40.4%) as compared to Ketorolac (10.4%). The similar analgesic efficacy to pethidine makes Ketorolac an appropriate drug for the relief of postoperative pain especially in day surgery settings where observation following administration of the drug as in the case of pethidine can be dispensed with and patients sent home earlier because of the minimal side effects associated with its use. Caution must be exercised with the use of large doses of Ketorolac especially if the drug is used for more than 5 days to avoid serious complications like renal failure and gastrointestinal bleeding.",1994,The pain relief obtained in the first four hours following administration of the drugs was similar for pethidine and Ketorolac.,['patients with pain following orthopaedic surgery'],"['Ketorolac tromethamine', 'pethidine', 'pethidine and Ketorolac', 'ketorolac tromethamine and pethidine hydrochloride', 'Ketorolac']","['peak analgesia', 'sustained pain relief, time to peak analgesia', 'pain relief', 'incidence of side effects', 'vertical visual analogue scale (VAS', 'mean pain (VAS) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0064326', 'cui_str': 'Ketorolac Tromethamine'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0353148', 'cui_str': 'Meperidine Hydrochloride'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.0310301,The pain relief obtained in the first four hours following administration of the drugs was similar for pethidine and Ketorolac.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Satku', 'Affiliation': 'Department of Orthopaedic Surgery, National University of Singapore.'}, {'ForeName': 'F O', 'Initials': 'FO', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'B P', 'Initials': 'BP', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Chhatwal', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1017,7710234,Epidural infusions of bupivacaine and fentanyl do not improve rehabilitation following one-stage bilateral total knee arthroplasty.,"Epidural analgesia with local anaesthetic minimizes the catabolic response to surgery. To determine whether this could enhance the rate of recovery following orthopaedic surgery, 51 patients undergoing bilateral one-stage total knee arthroplasty were allocated to receive infusions of either continuous epidural bupivacaine/fentanyl or continuous intravenous fentanyl to compare the efficacy of these modes of pain relief on postoperative clinical outcomes and rates of rehabilitation. Infusions were maintained for 36 to 48 hours in a post-anaesthesia care unit (PACU). Postoperatively, pain relief (visual analogue scale), attainment of physical therapy goals and cardiopulmonary complications were measured daily for 7 days. Epidural analgesia with a combination of bupivacaine and fentanyl did not result in any measurable improvement in rehabilitation milestones or reduction in postoperative complications following bilateral total knee arthroplasty than with fentanyl infusions alone.",1994,Epidural analgesia with a combination of bupivacaine and fentanyl did not result in any measurable improvement in rehabilitation milestones or reduction in postoperative complications following bilateral total knee arthroplasty than with fentanyl infusions alone.,"['51 patients undergoing bilateral one-stage total knee arthroplasty', 'one-stage bilateral total knee arthroplasty']","['continuous epidural bupivacaine/fentanyl', 'Epidural analgesia with local anaesthetic', 'bupivacaine and fentanyl']","['postoperative complications', 'catabolic response', 'pain relief (visual analogue scale), attainment of physical therapy goals and cardiopulmonary complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",51.0,0.0895306,Epidural analgesia with a combination of bupivacaine and fentanyl did not result in any measurable improvement in rehabilitation milestones or reduction in postoperative complications following bilateral total knee arthroplasty than with fentanyl infusions alone.,"[{'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Sharrock', 'Affiliation': 'Department of Anesthesiology, Hospital for Special Surgery, Cornell University Medical College, New York, NY 10021, USA.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Urquhart', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ganz', 'Affiliation': ''}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Williams-Russo', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1018,7710217,Combination of intramuscular Ketorolac and low dose epidural morphine for the relief of post-caesarean pain.,"Epidural morphine produces profound analgesia but also causes many adverse effects in a dose-dependent manner. This double-blind, randomized, prospective study evaluated the analgesic efficacy and safety of low dose (2 mg) epidural morphine in combination with 30 mg intramuscular (IM) Ketorolac, a non-steroidal anti-inflammatory drug with potent analgesic activity, in patients suffering pain after caesarean surgery. Ninety parturients who received epidural anaesthesia in the postoperative period were divided into 3 equal groups: group A received epidural morphine 2 mg plus IM placebo; group B received epidural morphine 2 mg plus IM Ketorolac 30 mg; and group C received epidural saline placebo plus IM Ketorolac 30 mg. All patients were observed for pain relief, vital signs and adverse effects for 24 hours post drug administration. Results showed that group B had statistically significant superior pain relief to that of the other 2 groups. The incidence of adverse effects was similar between those of group A and B. We concluded that the addition of Ketorolac by IM administration enhanced the analgesic effect of low dose (2 mg) epidural morphine in the relief of post-caesarean pain without potentiating its adverse effects.",1994,Results showed that group B had statistically significant superior pain relief to that of the other 2 groups.,"['Ninety parturients who received', 'patients suffering pain after caesarean surgery']","['epidural anaesthesia', 'epidural morphine 2 mg plus IM Ketorolac', 'epidural saline placebo plus IM Ketorolac', 'morphine', 'low dose (2 mg) epidural morphine in combination with 30 mg intramuscular (IM) Ketorolac', 'Epidural morphine', 'epidural morphine 2 mg plus IM placebo', 'Ketorolac', 'intramuscular Ketorolac and low dose epidural morphine']","['analgesic efficacy and safety', 'analgesic effect', 'adverse effects', 'pain relief, vital signs and adverse effects', 'relief of post-caesarean pain', 'superior pain relief']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1275733', 'cui_str': 'Mobile epidural'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0518766'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",,0.198452,Results showed that group B had statistically significant superior pain relief to that of the other 2 groups.,"[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Tzeng', 'Affiliation': 'Department of Anesthesiology, Municipal Women and Children Medical Center, Kaohsiung, Taiwan.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Mok', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1019,7944244,Sedation for gastroscopy: a comparison between midazolam and midazolam with nalbuphine.,"Forty patients received either midazolam or midazolam with nalbuphine in a double-blind randomised study of sedation for upper gastrointestinal endoscopy. There were less retching, gagging and salivation in the combination group compared to midazolam alone. They were also more cooperative. These resulted in greater ease of insertion of the gastroscope. There was no significant difference in the degree of amnesia in both groups. A significant decrease in oxygen saturation was noted in both groups during the procedure. Monitoring with a pulse oximeter is recommended when sedation is administered during gastroscopy.",1994,There was no significant difference in the degree of amnesia in both groups.,['Forty patients received either'],"['midazolam and midazolam with nalbuphine', 'midazolam or midazolam with nalbuphine', 'midazolam']","['greater ease of insertion of the gastroscope', 'degree of amnesia', 'oxygen saturation', 'retching, gagging and salivation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0181020', 'cui_str': 'Gastroscopes'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0002622', 'cui_str': 'Amnesia-Memory Loss'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0232602', 'cui_str': 'Retching (finding)'}, {'cui': 'C0036104', 'cui_str': 'Salivation'}]",,0.159078,There was no significant difference in the degree of amnesia in both groups.,"[{'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Chin', 'Affiliation': 'Department of Anaesthesia, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Chin', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1020,7979117,Subcutaneous infusion of ketamine and morphine for relief of postoperative pain: a double-blind comparative study.,Low dose ketamine by subcutaneous infusion (0.1 mg.kg-1.h-1) was compared in a double-blind fashion with a similar infusion of morphine (0.03 mg.kg-1.h-1) for postoperative analgesia in 60 ASA-I adults after major abdominal surgery. Pain was assessed using visual analogue scales and sedation was graded on a four-point rank drowsiness score. Cardiovascular and respiratory parameters were also recorded. Pain relief was better with the ketamine infusion than with morphine infusion (P < 0.001). Both tidal and minute volume parameters improved better with ketamine (P < 0.001); patients were more awake and alert as evidenced by the drowsiness score (P < 0.001). Nine out of 30 patients who received morphine required catheterisation for urinary retention (P < 0.05). The study revealed higher analgesic efficacy of a low dose subcutaneous infusion of ketamine with lesser sedation and fewer side effects.,1994,Both tidal and minute volume parameters improved better with ketamine (P < 0.001); patients were more awake and alert as evidenced by the drowsiness score (P < 0.001).,['60 ASA-I adults after major abdominal surgery'],"['morphine', 'ketamine', 'ketamine and morphine']","['Pain relief', 'Pain', 'analgesic efficacy', 'drowsiness score', 'postoperative pain', 'visual analogue scales and sedation', 'Cardiovascular and respiratory parameters', 'urinary retention']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}]",60.0,0.244011,Both tidal and minute volume parameters improved better with ketamine (P < 0.001); patients were more awake and alert as evidenced by the drowsiness score (P < 0.001).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences, Guru Teg Bahadur Hospital, Delhi, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gurnani', 'Affiliation': ''}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Sethi', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1021,7979119,Placebo effect of eutectic mixture of lidocaine and prilocaine (EMLA) cream in reducing venepuncture pain in children.,"A randomized double-blind study was made of 60 children aged 5 to 11 years to assess the efficacy of a eutectic mixture of local anaesthetics (EMLA), lidocaine and prilocaine, and placebo cream in reducing venepuncture pain. The 5% EMLA or placebo cream, approximately 2 grams (2 ml), was applied to the anticipated venepuncture site and covered with an occlusive dressing for a least 60 minutes. The venepuncture of 20-gauge butterfly needle was done after wiping the skin dry and observing for any local reactions. The pain was evaluated by three methods, one by the investigator and the other two by the children. The results showed that there were no statistical differences in the subject characteristics and pain scores, between the EMLA and the placebo group. Most children in both groups experienced no pain to mild pain from venepuncture. The possible causes were discussed and it was concluded that the placebo effect of having cream and good doctor-children rapport reduced fear and anxiety, resulting in the reduction of venepuncture pain in children.",1994,"The results showed that there were no statistical differences in the subject characteristics and pain scores, between the EMLA and the placebo group.","['60 children aged 5 to 11 years', 'children']","['placebo', 'Placebo', 'eutectic mixture of local anaesthetics (EMLA), lidocaine and prilocaine, and placebo cream', 'placebo cream', 'lidocaine and prilocaine (EMLA) cream']","['venepuncture pain', 'pain', 'fear and anxiety', 'subject characteristics and pain scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",60.0,0.186673,"The results showed that there were no statistical differences in the subject characteristics and pain scores, between the EMLA and the placebo group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lurngnateetape', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tritrakarn', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1022,31422680,Assessment of Bioabsorbable Hydroxyapatite for Secondary Bone Grafting in Unilateral Alveolar Clefts.,"PURPOSE


To evaluate the utility and efficacy of bioabsorbable hydroxyapatite and collagen complex (HA/Col) for secondary bone grafting in unilateral alveolar clefts.
PATIENTS AND METHODS


Between 2015 and 2016, 21 patients with unilateral cleft lips and alveolar clefts were enrolled. In group I, a cancellous iliac bone graft was placed at the alveolar cleft (6 males, 5 females). In group II, a bioabsorbable HA/Col was placed at the alveolar cleft (4 males, 7 females).
RESULTS


The groups did not differ in age, cleft volume, or surgical duration. There was a significant difference in intraoperative blood loss between the 2 groups (6.7 ± 1.89 mL in group II vs 38.8 ± 9.73 mL in group I [ P  < .01]). The use of patient-controlled intravenous analgesia was also significantly lower in group II than in group I (2.2 ± 1.9 times vs 12.2 ± 4.4 times [ P  < .01]). Only 1 female in group II who had maxillary sinusitis did not achieve osteosynthesis. With the exception of this patient, the 12-month bone volumes in groups I and II were 0.567 ± 0.066 and 0.596 ± 0.073 mL, respectively, without significant difference ( P  = .18).
CONCLUSION


Compared with an autogenous bone, bioabsorbable HA/Col significantly reduces postoperative pain. In addition, the use of HA/Col alone produced the same result as an autologous bone and is effective in filling the alveolar cleft.",2020,The use of patient-controlled intravenous analgesia was also significantly lower in group II than in group,"['Secondary Bone Grafting in Unilateral Alveolar Clefts', 'Between 2015 and 2016, 21 patients with unilateral cleft lips and alveolar clefts were enrolled']","['Bioabsorbable Hydroxyapatite', 'autogenous bone, bioabsorbable HA/Col', 'cancellous iliac bone graft', 'bioabsorbable HA/Col', 'bioabsorbable hydroxyapatite and collagen complex (HA/Col']","['postoperative pain', 'osteosynthesis', 'intraoperative blood loss', '12-month bone volumes']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392006'}]","[{'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C4521397', 'cui_str': 'US Military Commissioned Officer O6'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.031584,The use of patient-controlled intravenous analgesia was also significantly lower in group II than in group,"[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Orthodontics, Tokyo Dental College, Mihama Ward, Chiba, Japan.'}, {'ForeName': 'Tekenobu', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Orthodontics, Tokyo Dental College, Mihama Ward, Chiba, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619866372']
1023,31909412,Adapting the Diabetes Prevention Program for low- and middle-income countries: preliminary implementation findings from lifestyle Africa.,"Rates of cardiovascular disease and diabetes are rising in low- and middle-income countries (LMIC), but there is a dearth of research devoted to developing and evaluating chronic disease interventions in these settings, particularly in Africa. Lifestyle Africa is a novel, culturally adapted version of the Diabetes Prevention Program (DPP) being evaluated in an ongoing community-based cluster-randomized trial in an underresourced urban community in South Africa. The purpose of this study is to describe the adaptations and adaptation process used to develop the program and to report preliminary implementation findings from the first wave of groups (n = 11; 200 individuals) who participated in the intervention. The RE-AIM model and community advisory boards guided the adaptation process. The program was designed to be delivered by community health workers (CHWs) through video-assisted sessions and supplemented with text messages. Participants in the trial were overweight and obese members of existing chronic disease ""support groups"" served via CHWs. Implementation outcomes included completion of sessions, session attendance, fidelity of session delivery, and participant satisfaction. Results indicated that 10/11 intervention groups completed all 17 core sessions. Average attendance across all sessions and groups was 54% and the percentage who attended at least 75% of sessions across all groups was 35%. Fidelity monitoring indicated a mean of 84% of all required procedures were completed while overall communication skills were rated as ""good"" to ""excellent"". These preliminary results support the feasibility of culturally adapting the DPP for delivery by CHWs in underresourced settings in LMIC.",2020,Average attendance across all sessions and groups was 54% and the percentage who attended at least 75% of sessions across all groups was 35%.,"['underresourced urban community in South Africa', 'groups (n = 11; 200 individuals) who participated in the intervention', 'Participants in the trial were overweight and obese members of existing chronic disease ""support groups"" served via CHWs']",[],"['overall communication skills', 'completion of sessions, session attendance, fidelity of session delivery, and participant satisfaction', 'Average attendance']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",200.0,0.0235903,Average attendance across all sessions and groups was 54% and the percentage who attended at least 75% of sessions across all groups was 35%.,"[{'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Puoane', 'Affiliation': 'School of Public Health, University of the Western Cape, Belleville, South Africa.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Lungiswa P', 'Initials': 'LP', 'LastName': 'Tsolekile', 'Affiliation': 'School of Public Health, University of the Western Cape, Belleville, South Africa.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kandace', 'Initials': 'K', 'LastName': 'Fleming', 'Affiliation': 'Life Span Institute, University of Kansas Department of Psychology, Lawrence, KS, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schlachter', 'Affiliation': ""Division of Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Mara Z', 'Initials': 'MZ', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Estelle V', 'Initials': 'EV', 'LastName': 'Lambert', 'Affiliation': 'UCT Research Centre for Health through Physical Activity, Lifestyle and Sport (HPALS), Division of Exercise Science and Sports Medicine, Faculty of Health Sciences, University of Cape Town 7700, Cape Town, South Africa.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Hassen', 'Affiliation': 'School of Public Health, University of the Western Cape, Belleville, South Africa.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Muhali', 'Affiliation': 'School of Public Health, University of the Western Cape, Belleville, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schoor', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Kansas City, Kansas City, MO, USA.""}]",Translational behavioral medicine,['10.1093/tbm/ibz187']
1024,31419449,Effects of moderate- and high-intensity acute aerobic exercise on food reward and appetite in individuals with methamphetamine dependence.,"PURPOSE


Drug addiction is characterised by overvaluation of drug-related rewards and undervaluation of ""natural"", non-drug-related rewards. Methamphetamine (MA) is the second largest illegally abused drug in the world. Studies have shown that acute aerobic exercise can reduce the incidence of MA-dependent individuals' craving for drug-related cues, but the impact of exercise on food reward in this population has yet to be established. The aim of this study was to determine the effects of moderate and high-intensity acute aerobic exercise on food reward and subjective feelings of appetite in MA-dependent populations.
METHODS


Forty-four men, who met the DSM-V criteria for MA dependence, with BMI of 24.7 ± 3.1 kg/m 2  and age of 31.9 ± 3.8 years, were randomly assigned to two exercise training groups: moderate- (n = 22; 65%~75% HRmax) or high- (n = 22; ≥ 85% HRmax) intensity. Each group performed a resting control or exercise session for 35 min, 1wk apart, in a counterbalanced order. Food reward (explicit liking, implicit wanting and relative preference) for high or low fat and sweet or savoury food images was assessed by the Leeds Food Preference Questionnaire and subjective feelings of appetite were measured by VAS.
RESULTS


Greater relative preference (high: P = .018; moderate: P = .034) and implicit wanting (high: P = .018; moderate: P = .034) for high-fat savoury foods was noted following acute aerobic exercise compared to the control session. Exercise also increased subjective sensations of hunger (F (1,42) =8.28, P = .006).
CONCLUSIONS


The current study provides the first evidence that acute aerobic exercise can increase reward for high fat savoury foods and stimulate appetite in MA-dependent individuals. In the context of exercise as a therapeutic option for MA dependence, these changes suggest an improvement in responsiveness to natural, non-drug rewards.",2019,"Exercise also increased subjective sensations of hunger (F (1,42) =8.28, P = .006).
","['Forty-four men, who met the DSM-V criteria for MA dependence, with BMI of 24.7\u202f±\u202f3.1\u202fkg/m 2  and age of 31.9\u202f±\u202f3.8\u202fyears', 'MA-dependent populations', 'individuals with methamphetamine dependence']","['moderate and high-intensity acute aerobic exercise', 'resting control or exercise session', 'exercise training groups: moderate- (n\u202f=\u202f22; 65%~75% HRmax) or high', 'acute aerobic exercise', 'Methamphetamine (MA', 'moderate- and high-intensity acute aerobic exercise']","['subjective sensations of hunger', 'food reward and subjective feelings of appetite', 'Food reward (explicit liking, implicit wanting and relative preference', 'food reward and appetite', 'Leeds Food Preference Questionnaire and subjective feelings of appetite']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",44.0,0.0540387,"Exercise also increased subjective sensations of hunger (F (1,42) =8.28, P = .006).
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""School of Psychology, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Yingzhi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""School of Psychology, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Xinhong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ""School of Psychology, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""School of Psychology, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine & Health, University of Leeds, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""School of Psychology, Shanghai University of Sport, Shanghai, People's Republic of China. Electronic address: chenglin_600@126.com.""}]",Physiology & behavior,['10.1016/j.physbeh.2019.112649']
1025,7611285,Teaching about cystic fibrosis carrier screening by using written and video information.,"We performed two studies using only written and video materials to educate people about cystic fibrosis (CF) and carrier screening. Participants were randomized to receive written or video materials. All received a brief questionnaire. Subjects in group I (n = 238) were (1) individuals in steady relationships and their partners, (2) > or = 18 years old, and (3) not pregnant. Those who accepted free screening and were not demonstrable carriers were sent a letter explaining their results and another questionnaire. Subjects in group II (n = 108) were parents seeking well child care in a university clinic. The main outcome measures were ability to answer questions correctly about (1) health status of CF carriers and people with CF, (2) the possibility of false-negative results, and (3) for those who had screening, the implications of their own results. Written and video materials were equally effective in conveying information. Prior to screening, subjects answered an average of 86% of questions correctly. Subjects with less formal education answered fewer questions correctly; 60% of those with less than a high school education had adequate knowledge of the health consequences of having CF or being a carrier, compared with > or = 94% of college graduates. Performance improved after screening. Where neither partner was a demonstrable carrier, 88% knew their own and their partner's test results, and 90% indicated that their risk of having a child with CF was not zero. Written and video educational materials can be used without face-to-face counseling to inform most people about carrier screening and their test results. These materials may be less effective for those with lower educational backgrounds.",1995,Written and video educational materials can be used without face-to-face counseling to inform most people about carrier screening and their test results.,"['Subjects in group I (n = 238) were (1) individuals in steady relationships and their partners, (2) > or = 18 years old, and (3) not pregnant', 'Subjects in group II (n = 108) were parents seeking well child care in a university clinic']",['written or video materials'],"['ability to answer questions correctly about (1) health status of CF carriers and people with CF, (2) the possibility of false-negative results, and (3']","[{'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0205558', 'cui_str': 'False negative (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",238.0,0.0142545,Written and video educational materials can be used without face-to-face counseling to inform most people about carrier screening and their test results.,"[{'ForeName': 'E W', 'Initials': 'EW', 'LastName': 'Clayton', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Hannig', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Pfotenhauer', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Phillips', 'Affiliation': ''}]",American journal of human genetics,[]
1026,31420960,A Mobile Phone App Featuring Cue Exposure Therapy As Aftercare for Alcohol Use Disorders: An Investigator-Blinded Randomized Controlled Trial.,"BACKGROUND


Cue exposure therapy (CET) is a psychological approach developed to prepare individuals with alcohol use disorder (AUD) for confronting alcohol and associated stimuli in real life. CET has shown promise when treating AUD in group sessions, but it is unknown whether progressing from group sessions to using a mobile phone app is an effective delivery pathway.
OBJECTIVE


The objectives of this study were to investigate (1) whether CET as aftercare would increase the effectiveness of primary treatment with cognitive behavior therapy, and (2) whether CET delivered through a mobile phone app would be similarly effective to CET via group sessions.
METHODS


A total of 164 individuals with AUD were randomized to one of three groups: CET as group aftercare (CET group), CET as fully automated mobile phone app aftercare (CET app), or aftercare as usual. Study outcomes were assessed face-to-face at preaftercare, postaftercare, and again at 6 months after aftercare treatment. Generalized mixed models were used to compare the trajectories of the groups over time on drinking, cravings, and use of urge-specific coping skills (USCS).
RESULTS


In all, 153 of 164 individuals (93%) completed assessments both at posttreatment and 6-month follow-up assessments. No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time. Both CET group (predicted mean difference 5.99, SE 2.59, z=2.31, P=.02) and the CET app (predicted mean difference 4.90, SE 2.26, z=2.31, P=.02) showed increased use of USCS compared to aftercare as usual at posttreatment, but this effect was reduced at the 6-month follow-up. No differences were detected between the two experimental CET groups on any outcomes.
CONCLUSIONS


CET with USCS delivered as aftercare either via group sessions or a mobile phone app did not increase the effectiveness of primary treatment. This suggests that CET with USCS may not be an effective psychological approach for the aftercare of individuals treated for AUD.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02298751; https://clinicaltrials.gov/ct2/show/NCT02298751.",2019,No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time.,['164 individuals with AUD'],"['CET as group aftercare (CET group), CET as fully automated mobile phone app aftercare (CET app), or aftercare as usual', 'CET', 'CET with USCS', 'Cue exposure therapy (CET', 'Mobile Phone App Featuring Cue Exposure Therapy', 'USCS']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]",[],164.0,0.0788876,No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time.,"[{'ForeName': 'Angelina Isabella', 'Initials': 'AI', 'LastName': 'Mellentin', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Technology Entrepreneurship and Innovation section, Mads Clausen Institute, University of Southern Denmark, Sønderborg, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mejldal', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Dorthe Grüner', 'Initials': 'DG', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Elsebeth', 'Initials': 'E', 'LastName': 'Stenager', 'Affiliation': 'Brain Research-Inter-Disciplinary Guided Excellence, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}]",JMIR mHealth and uHealth,['10.2196/13793']
1027,32495306,Development of an Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake for Preventing Hypertension and Chronic Disease in Filipino Americans.,"Hypertension is a common chronic health condition affecting Filipino Americans. This pilot study examined the feasibility of addressing high rates of hypertension among Filipino Americans through the implementation of a culturally tailored education intervention. Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework. The study included pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake. The intervention to promote physical activity and reduce salt intake was conducted through two educational sessions and was accompanied by follow-up at 3 months and by the collection of urine samples for 24-h urinary sodium intake biomarker analysis. Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups. For systolic blood pressure, a reduction of 12.6 mmHg and an increase in 5.3 mmHg was observed in the intervention and control groups, respectively. Diastolic pressure decreased 3.8 mmHg for the intervention group and increased 5.6 mmHg among controls. The culturally tailored education intervention reported here represents a promising tool for blood pressure reduction in high-risk ethnic populations. The methods used were effective for the recruitment and retention of ethnic minorities in a community-based setting.",2020,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","['Filipino Americans', 'Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework']","['Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake', 'culturally tailored education intervention']","['Diastolic pressure', 'pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake', 'systolic blood pressure', 'urine sodium']","[{'cui': 'C0597918', 'cui_str': 'Filipino Americans'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine'}]",,0.0143801,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","[{'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA. grace.ma@temple.edu.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Bhimla', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Beeber', 'Affiliation': 'Hunter College, The City University of New York (CUNY), New York, NY, USA.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Aczon', 'Affiliation': 'Filipino American Society of South Jersey Inc., Mount Laurel, NJ, 08084, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Sally Boyle', 'Initials': 'SB', 'LastName': 'Quinn', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Crystal A', 'Initials': 'CA', 'LastName': 'Gadegbeku', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00781-z']
1028,31420883,Effects of acute prolonged sitting on cerebral perfusion and executive function in young adults: A randomized cross-over trial.,"Exposure to acute prolonged sitting reportedly leads to decreased cerebral blood flow. However, it is unclear whether this exposure translates to decreased cerebral perfusion and executive function or whether simple strategies to break up sitting can maintain cerebral perfusion and executive function. This study sought to answer two questions: in young, healthy adults, (a) does prolonged (3 hr) sitting lead to decreased cerebral perfusion and executive function? and (b) does breaking up prolonged sitting, using intermittent calf raise exercises, prevent changes in cerebral perfusion and executive function? Twenty young, healthy participants (21.7 [2.5] years, 70% female, 25.5 [6.1] kg/m 2  ) were randomized to 3 hr sitting with 10 calf raises every 10 min (CALF) and 3 hr sitting without intermittent calf raises (CON). Prefrontal cortex perfusion was assessed using near-infrared spectroscopy to monitor total hemoglobin (tHB) concentration and tissue saturation index (TSI, oxygenated hemoglobin). Executive function was assessed using the Stroop word and color tasks. Following 3 hr sitting, tHb was significantly lower in CALF versus CON (-2.1 μM, 95% CI [-3.1, -1.1]). TSI was not significantly different between conditions (p = .667). Word (1.6 ms, 95% CI [0.7, 2.5]) and color (1.3 ms, 95% CI [-0.2, 2.8]) completion times were longer (worse) for CALF compared to CON. In conclusion, calf raises decreased both cerebral perfusion and executive function. Simple strategies, such as fidgeting or calf raises, which have been reported to preserve vascular function in the legs, appear not to be sufficient to benefit cerebral perfusion or executive function.",2019,TSI was not significantly different between conditions (p = .667).,"['young, healthy adults, (a) does prolonged (3\xa0hr) sitting lead to decreased cerebral perfusion and executive function', 'Twenty young, healthy participants (21.7 [2.5] years, 70% female, 25.5 [6.1] kg/m 2  ', 'young adults']","['acute prolonged sitting', 'hr sitting without intermittent calf raises (CON', 'hr sitting with 10 calf raises every 10\xa0min (CALF) and 3']","['Stroop word and color tasks', 'Executive function', 'cerebral blood flow', 'TSI', 'cerebral perfusion and executive function', 'Prefrontal cortex perfusion', 'tHB) concentration and tissue saturation index (TSI, oxygenated hemoglobin']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0040139', 'cui_str': 'Thyroid-Stimulating Antibodies'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",20.0,0.0261136,TSI was not significantly different between conditions (p = .667).,"[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Willey', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Burnet', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, Mississippi.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Psychophysiology,['10.1111/psyp.13457']
1029,31420374,Higher negative emotions in response to cigarette pictorial warning labels predict higher quit intentions among smokers.,"BACKGROUND


Cigarette pictorial warning labels (PWLs) could produce stronger quit intentions than text-only warning labels (TWLs) due to greater emotional arousal. Yet, it remains unclear whether PWLs that elicit different levels of emotions produce different outcomes. To better understand the role of negative emotions in the effects of PWLs, this study developed two sets of PWLs arousing different emotional levels (high vs low) but equally high on informativeness and compared them to each other and to the current TWLs.
METHODS


Adult US smokers (n=1503) were randomised to view nine high-emotion-arousing or low-emotion-arousing PWLs or TWLs. After each label, participants reported the negative emotions they felt while looking at the label. After seeing all the labels, participants reported their intentions to quit smoking. Mediation analyses tested whether message condition influenced quit intentions indirectly through negative emotions.
RESULTS


Compared with TWLs, PWLs produced higher levels of negative emotions (b=0.27, SE=0.04, p<0.001). Compared with low-emotion arousing PWLs, high-emotion-arousing PWLs produced higher levels of negative emotions (b = 0.24, SE=0.07, p<0.001). Higher negative emotions predicted stronger quit intentions (b=0.20, SE=0.03, p<0.001). Negative emotions mediated the effects of PWLs versus TWLs and high-emotion-arousing versus low- emotion-arousing PWLs on quit intentions.
CONCLUSIONS


The results provide additional evidence for negative emotions as the mechanism through which PWLs motivate smokers to consider quitting. The findings call on the Food and Drug Administration to design and implement high-emotion-arousing cigarette warning labels.",2020,"Compared with TWLs, PWLs produced higher levels of negative emotions (b=0.27, SE=0.04, p<0.001).",['Adult US smokers (n=1503'],"['cigarette pictorial warning labels', 'Cigarette pictorial warning labels (PWLs', 'PWLs versus TWLs and high-emotion-arousing versus low- emotion-arousing PWLs', 'emotion-arousing or low-emotion-arousing PWLs or TWLs']","['intentions to quit smoking', 'negative emotions', 'Higher negative emotions predicted stronger quit intentions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}]",,0.0446065,"Compared with TWLs, PWLs produced higher levels of negative emotions (b=0.27, SE=0.04, p<0.001).","[{'ForeName': 'Yachao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Communication Studies and Department of Public Health, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Owusu', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA lpopova1@gsu.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055116']
1030,31194627,Effect of Instructional Format on Veterinary Students' Task Performance and Emotional State during a Simulation-Based Canine Endotracheal Intubation Laboratory: Handout versus Video.,"Video- versus handout-based instructions may influence student outcomes during simulation training and competency-based assessments. Forty-five third-year veterinary students voluntarily participated in a simulation module on canine endotracheal intubation. A prospective, randomized, double-blinded study investigated the impact of video ( n  = 23) versus handout ( n  = 22) instructions on student confidence, anxiety, and task performance. Students self-scored their confidence and anxiety before and after the simulation. During the simulation laboratory, three raters independently evaluated student performance using a 20-item formal assessment tool with a 5-point global rating scale. No significant between- or within-group differences ( p  > .05) were found for both confidence and anxiety scores. Video-based instructions were associated with significantly higher ( p  < .05) total formal assessment scores compared with handout-based instructions. The video group had significantly higher scores than the handout group on 3 of the 20 individual skills (items) assessed: placement of tie to the adaptor-endotracheal tube complex ( p  < .05), using the anesthetic machine ( p  < .01), and pop-off valve management ( p  < .001). Inter-rater reliability as assessed by Cronbach's α (.92), and Kendall's  W  (.89) was excellent and almost perfect, respectively. A two-faceted crossed-design generalizability analysis yielded  G  coefficients for both the handout ( E p 2  = .68) and the video ( E p 2  = .72) groups. Video instructions may be associated with higher performance scores than handout instructions during endotracheal intubation simulation training. Further research into skill retention and learning styles is warranted.",2020,Video-based instructions were associated with significantly higher ( p  < .05) total formal assessment scores compared with handout-based instructions.,['Forty-five third-year veterinary students voluntarily participated in a'],"['simulation module on canine endotracheal intubation', 'video ( n  = 23) versus handout ( n  = 22) instructions', 'Instructional Format', 'Video- versus handout-based instructions']","['5-point global rating scale', 'total formal assessment scores', ""Veterinary Students' Task Performance and Emotional State"", 'anxiety scores', 'student confidence, anxiety, and task performance', 'higher student confidence and performance scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.104766,Video-based instructions were associated with significantly higher ( p  < .05) total formal assessment scores compared with handout-based instructions.,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cosford', 'Affiliation': 'Department of Small Animal Clinical Sciences, Western College of Veterinary Medicine, University of Saskatchewan.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Briere', 'Affiliation': 'Department of Psychology at St. Thomas More College, University of Saskatchewan.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ambros', 'Affiliation': 'Department of Small Animal Clinical Sciences, Western College of Veterinary Medicine, University of Saskatchewan.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Beazley', 'Affiliation': 'Department of Small Animal Clinical Sciences, Western College of Veterinary Medicine, University of Saskatchewan.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Cartwright', 'Affiliation': 'Western College of Veterinary Medicine, University of Saskatchewan.'}]",Journal of veterinary medical education,['10.3138/jvme.0618-077r1']
1031,32138746,Legacy effect of fibrate add-on therapy in diabetic patients with dyslipidemia: a secondary analysis of the ACCORDION study.,"BACKGROUND


The Action to Control Cardiovascular Risk in Diabetes (ACCORD)-Lipid study found no evidence of a beneficial effect of statin-fibrate combined treatment, compared to statins alone, on cardiovascular outcomes and mortality in type 2 diabetes mellitus after 5 years of active treatment. However, a beneficial reduction in major CVD events was shown in a pre-specified sub-group of participants with dyslipidemia. The extended follow-up of this trial provides the opportunity to further investigate possible beneficial effects of fibrates in this group of patients. We aimed to evaluate possible ""legacy effects"" of fibrate add-on therapy on mortality and major cardiovascular outcomes in patients with dyslipidemia.
METHODS


The ACCORD-lipid study was a randomized controlled trial of 5518 participants assigned to receive simvastatin plus fenofibrate vs simvastatin plus placebo. After randomized treatment allocation had finished at the end of the trial, all surviving participants were invited to attend an extended follow-up study (ACCORDION) to continue prospective collection of clinical outcomes. We undertook a secondary analysis of trial and post-trial data in patients who had dyslipidemia. The primary outcome was all-cause and cardiovascular mortality, and secondary outcomes were nonfatal myocardial infarction, stroke, congestive heart failure and major coronary heart disease. We used an intention-to-treat approach to analysis to make comparisons between the original randomized treatment groups.
RESULTS


853 participants with dyslipidemia had survived at the end of the trial. Most participants continued to use statins, but few used fibrates in either group during the post-trial period. The incidence rates in the fenofibrate group were lower with respect to all-cause mortality, CVD mortality, nonfatal myocardial infarction, congestive heart failure and major coronary heart disease than those in the placebo group over a post-trial follow-up. Allocation to the combined fibrate-statin treatment arm during the trial period had a beneficial legacy effect on all-cause mortality (adjusted HR = 0.65, 95% CI 0.45-0.94; P = 0.02).
CONCLUSIONS


Fibrate treatment during the initial trial period was associated with a legacy benefit of improved survival over a post-trial follow-up. These findings support re-evaluation of fibrates as an add-on strategy to statins in order to reduce cardiovascular risk in diabetic patients with dyslipidemia. Trial registration clinicaltrials.gov, Identifier: NCT00000620.",2020,"The incidence rates in the fenofibrate group were lower with respect to all-cause mortality, CVD mortality, nonfatal myocardial infarction, congestive heart failure and major coronary heart disease than those in the placebo group over a post-trial follow-up.","['5518 participants assigned to receive', 'patients who had dyslipidemia', 'patients with dyslipidemia', 'diabetic patients with dyslipidemia', '853 participants with dyslipidemia had survived at the end of the trial', 'type 2 diabetes mellitus after 5\xa0years of active treatment']","['placebo', 'simvastatin plus fenofibrate vs simvastatin plus placebo', 'fenofibrate']","['nonfatal myocardial infarction, stroke, congestive heart failure and major coronary heart disease', 'mortality and major cardiovascular outcomes', 'cause and cardiovascular mortality', 'mortality, CVD mortality, nonfatal myocardial infarction, congestive heart failure and major coronary heart disease', 'legacy benefit of improved survival', 'incidence rates', 'cardiovascular risk']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2979241', 'cui_str': 'Legacy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",5518.0,0.224535,"The incidence rates in the fenofibrate group were lower with respect to all-cause mortality, CVD mortality, nonfatal myocardial infarction, congestive heart failure and major coronary heart disease than those in the placebo group over a post-trial follow-up.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia. Lin.Zhu@uts.edu.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Katy J L', 'Initials': 'KJL', 'LastName': 'Bell', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01002-x']
1032,31944801,A cluster randomized controlled trial of more appreciation and less criticism in Hong Kong parents.,"Our cluster randomized controlled trial tested, respectively, 2 brief interventions to promote more appreciation and less criticism in Hong Kong Chinese parents toward their children and to enhance family well-being. We randomized 56 primary schools and community service centers (clusters of parents of primary grades 3-6 students) to the more appreciation (MA) or less criticism (LC) intervention arms, or fruit and vegetable control arm (FV). A total of 803 parents received a 2-hr workshop on increasing appreciation (19 clusters,  n  = 270), reducing criticism (21 clusters,  n  = 336), or increasing fruit and vegetable consumption (16 clusters,  n  = 197) and were assessed at baseline, immediately after the workshop, at 2 weeks, and at 6 weeks. Primary outcomes were parents' frequency of appreciation and criticism behaviors. Secondary outcomes were family well-being and potential behavioral determinants proposed by the Health Action Process Approach, including outcome expectancies, self-efficacy, intention, and planning behavior. At 6 weeks, the MA and LC arms reported greater increases in appreciation behavior than the FV arm, and the LC arm reported greater decreases in criticism than the FV arm, with small effect sizes. Specific improvements were also observed in the behavioral determinants at various time points compared with the FV arm. Similar improvements in family well-being were observed across all arms. Our findings were the first to show that brief Health Action Process Approach-based workshops on Chinese parents were effective in promoting positive parental behaviors. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"At 6 weeks, the MA and LC arms reported greater increases in appreciation behavior than the FV arm, and the LC arm reported greater decreases in criticism than the FV arm, with small effect sizes.","['56 primary schools and community service centers (clusters of parents of primary grades 3-6 students) to the', '803 parents', 'Hong Kong parents']","['more appreciation (MA) or less criticism (LC) intervention arms, or fruit and vegetable control arm (FV', '2-hr workshop on increasing appreciation (19 clusters,  n  = 270), reducing criticism (21 clusters,  n  = 336), or increasing fruit and vegetable consumption']","['family well-being and potential behavioral determinants proposed by the Health Action Process Approach, including outcome expectancies, self-efficacy, intention, and planning behavior', ""parents' frequency of appreciation and criticism behaviors"", 'appreciation behavior']","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0009482', 'cui_str': 'Services, Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",56.0,0.114852,"At 6 weeks, the MA and LC arms reported greater increases in appreciation behavior than the FV arm, and the LC arm reported greater decreases in criticism than the FV arm, with small effect sizes.","[{'ForeName': 'Samantha S W', 'Initials': 'SSW', 'LastName': 'Fung', 'Affiliation': 'School of Public Health.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Public Health.'}, {'ForeName': 'Patrick K W', 'Initials': 'PKW', 'LastName': 'Man', 'Affiliation': 'Tung Wah Group of Hospitals.'}, {'ForeName': 'Janet C M', 'Initials': 'JCM', 'LastName': 'Ip', 'Affiliation': 'Tung Wah Group of Hospitals.'}, {'ForeName': 'Alice N T', 'Initials': 'ANT', 'LastName': 'Wan', 'Affiliation': 'School of Public Health.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Sai Yin', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'School of Public Health.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000628']
1033,7344590,The antihypertensive action of acebutolol.,"Acebutolol is a relatively ""cardioselective"" beta-adrenergic blocking agent with an antihypertensive action. The aims of this investigation were to establish the effective dosage range, to study the effect on supine, standing and exercise blood pressure (BP) and heart rate (HR), and to compare the efficacy of once daily (OM) with twice daily (BD) dosing of acebutolol. This was a within patient, double-blind, randomised study. This study shows that the optimum dosage of acebutolol for control of BP and heart rate is 400mg or more daily, and that OM dosing seems to be as effective as BD dosing for supine, standing and post exercise BP control, but is less so for heart rate control.",1981,"Acebutolol is a relatively ""cardioselective"" beta-adrenergic blocking agent with an antihypertensive action.",[],"['acebutolol', 'Acebutolol', 'OM']","['supine, standing and exercise blood pressure (BP) and heart rate (HR']",[],"[{'cui': 'C0000946', 'cui_str': 'Acebutolol'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0901199,"Acebutolol is a relatively ""cardioselective"" beta-adrenergic blocking agent with an antihypertensive action.","[{'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Low', 'Affiliation': ''}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Koh', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1034,6753711,Finger tip injuries--a prospective study on seven methods of treatment on 200 cases.,"7 common methods of treatment were selected at random for 200 cases of finger tip injuries. The methods included split skin grafting, full-thickness skin grafting, volar V-Y advancement, Kutler's bilateral V-Y advancement, revision amputation, cross-finger flap and simple dressing. These cases were seen weekly until healing was completed and then at 3 and 6 months. A proper functional assessment was given to each case at the last visit. The results were analysed along the parameters of wound healing, appearance, scar condition, sensory return, finger joint movements, motor-power and sick-leave benefits. The best results were obtained from the volar V-Y advancement method. Results were most unfavourable when cross-finger flaps were used. This latter method, therefore, was condemned. Simple dressing gave excellent results if one disregarded the lengthy period of wound healing, a somewhat tender scar and possible beaking of the nails. The other methods gave satisfactory results but had no outstanding advantage.",1982,The other methods gave satisfactory results but had no outstanding advantage.,['200 cases'],"[""split skin grafting, full-thickness skin grafting, volar V-Y advancement, Kutler's bilateral V-Y advancement, revision amputation, cross-finger flap and simple dressing""]","['wound healing, appearance, scar condition, sensory return, finger joint movements, motor-power and sick-leave benefits']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0191474', 'cui_str': 'Full thickness skin transplantation'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0441479', 'cui_str': 'V-Y advancement technique (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0440965', 'cui_str': 'Cross finger flap (substance)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0016125', 'cui_str': 'Interphalangeal Joint of Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}]",,0.0125121,The other methods gave satisfactory results but had no outstanding advantage.,"[{'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Leung', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1035,6354056,Use of a semi-permeable membrane dressing in donor sites in Nigerians.,"Most published studies on the use of a semi-permeable membrane dressing (opsite) on split-skin donor sites have been on Caucasians. To assess this new method on the black population of a developing country where donor sites are notoriously slow to heal, a study was conducted on fifty Nigerians of varying age groups in whom split-skin grafts of identical thickness were taken from both thighs by the same surgeon: 100 donor sites were studied. In all the patients one thigh was dressed with the conventional sofratulle and the other with opsite. The allocation was made randomly. Twenty-five donor sites (53.4%) treated with sofratulle healed by the 13th postoperative day. By contrast, thirty donor sites (62.5%) treated with opsite healed by the 7th postoperative day. All opsite treated wounds were completely healed by the 11th day but it took nearly four weeks for the sofratulle treated thighs to heal. Minimal discomfort was experienced by 10% of the patients treated with opsite but about 80% of those treated with sofratulle required mild analgesics on ambulation during the first 48 hours on account of pain. Opsite effectively reduces healing time in donor sites, is easy to apply, less bulky to use, painfree and well tolerated by patients.",1983,"Opsite effectively reduces healing time in donor sites, is easy to apply, less bulky to use, painfree and well tolerated by patients.","['black population of a developing country where donor sites are notoriously slow to heal, a study was conducted on fifty Nigerians of varying age groups in whom split-skin grafts of identical thickness were taken from both thighs by the same surgeon: 100 donor sites were studied', 'donor sites in Nigerians']",['semi-permeable membrane dressing'],"['Minimal discomfort', 'healing time']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011750', 'cui_str': 'Under-Developed Nations'}, {'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1556089', 'cui_str': 'Nigerians (ethnic group)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0230429', 'cui_str': 'Both thighs (body structure)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0205326', 'cui_str': 'Permeable (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0127396,"Opsite effectively reduces healing time in donor sites, is easy to apply, less bulky to use, painfree and well tolerated by patients.","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Iregbulem', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
1036,32438407,Thrombosis in patients with myeloma treated in the Myeloma IX and Myeloma XI phase 3 randomized controlled trials.,"Newly diagnosed multiple myeloma (NDMM) patients treated with immunomodulatory drugs are at high risk of venous thromboembolism (VTE), but data are lacking from large prospective cohorts. We present thrombosis outcome data from Myeloma IX (n = 1936) and Myeloma XI (n = 4358) phase 3 randomized controlled trials for NDMM that treated transplant-eligible and transplant-ineligible patients before and after publication of thrombosis prevention guidelines. In Myeloma IX, transplant-eligible patients randomly assigned to cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) induction had higher risk of VTE compared with patients treated with cyclophosphamide, thalidomide, and dexamethasone (CTD) (22.5% [n = 121 of 538] vs 16.1% [n = 89 of 554]; adjusted hazard ratio [aHR],1.46; 95% confidence interval [95% CI], 1.11-1.93). For transplant-ineligible patients, those randomly assigned to attenuated CTD (CTDa) induction had a higher risk of VTE compared with those treated with melphalan and prednisolone (MP) (16.0% [n = 68 of 425] vs 4.1% [n = 17 of 419]; aHR, 4.25; 95% CI, 2.50-7.20). In Myeloma XI, there was no difference in risk of VTE (12.2% [n = 124 of 1014] vs 13.2% [n = 133 of 1008]; aHR, 0.92; 95% CI, 0.72-1.18) or arterial thrombosis (1.2% [n = 12 of 1014] vs 1.5% [n = 15 of 1008]; aHR, 0.80; 95% CI, 0.37-1.70) between transplant-eligible pathways for patients treated with cyclophosphamide, lenalidomide, and dexamethasone (CRD) or CTD. For transplant-ineligible patients, there was no difference in VTEs between attenuated CRD (CRDa) and CTDa (10.4% [n = 95 of 916] vs 10.7% [n = 97 of 910]; aHR, 0.97; 95% CI, 0.73-1.29). However, arterial risk was higher with CRDa than with CTDa (3.1% [n = 28 of 916] vs 1.6% [n = 15 of 910]; aHR, 1.91; 95% CI, 1.02-3.57). Thrombotic events occurred almost entirely within 6 months of treatment initiation. Thrombosis was not associated with inferior progression-free survival (PFS) or overall survival (OS), apart from inferior OS for patients with arterial events (aHR, 1.53; 95% CI, 1.12-2.08) in Myeloma XI. The Myeloma XI trial protocol incorporated International Myeloma Working Group (IMWG) thrombosis prevention recommendations and compared with Myeloma IX, more patients received thromboprophylaxis (80.5% vs 22.3%) with lower rates of VTE for identical regimens (CTD, 13.2% vs 16.1%; CTDa, 10.7% vs 16.0%). However, thrombosis remained frequent in spite of IMWG-guided thromboprophylaxis, suggesting that new approaches are needed.",2020,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","['Patients with Myeloma Treated in the Myeloma IX and Myeloma XI', 'Newly diagnosed multiple myeloma (NDMM) patients treated with', 'Myeloma IX (n=1936) and Myeloma XI (n=4358), phase III randomized controlled trials for NDMM, treating transplant-eligible and ineligible patients before and after publication of thrombosis prevention guidelines']","['immunomodulatory drugs (IMiDs', 'CRD (cyclophosphamide, lenalidomide and dexamethasone', 'CVAD induction (cyclophosphamide, vincristine, doxorubicin and dexamethasone', 'MP (melphalan and prednisolone', 'CTD (cyclophosphamide, thalidomide and dexamethasone']","['Thrombosis', 'arterial risk', 'VTE rates', 'Thrombotic events', 'inferior progression-free or overall survival (OS', 'VTE or arterial thrombosis risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0082139', 'cui_str': 'CVAD protocol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}]","[{'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}]",,0.147899,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","[{'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Bradbury', 'Affiliation': 'School of Translational Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Craig', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hockaday', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paterson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology, School of Immunity and Infection, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Health, New York, NY; and.'}, {'ForeName': 'J Anthony', 'Initials': 'JA', 'LastName': 'Child', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Health, New York, NY; and.'}, {'ForeName': 'Graham H', 'Initials': 'GH', 'LastName': 'Jackson', 'Affiliation': 'Freeman Hospital, University of Newcastle, Newcastle Upon Tyne, United Kingdom.'}]",Blood,['10.1182/blood.2020005125']
1037,32438481,Intravesical prostatic protrusion does not compromise the therapeutic effects of Mirabegron in male patients with overactive bladder.,"AIMS


Intravesical prostatic protrusion (IPP) is associated with the degree of benign prostatic obstruction. We evaluated the effects of Mirabegron, a selective β3 adrenoceptor agonist, on overactive bladder (OAB) in male patients with different degrees of IPP.
METHODS


About 185 male patients ≥40 years with lower urinary tract symptoms were recruited from a tertiary referral center. OAB was defined by the overactive bladder symptom score (OABSS) urgency score of ≥2 and sum score of ≥3. IPP was measured in the midsagittal section using transrectal ultrasound and patients were divided into IPP ≤5 mm and IPP >5 mm groups. Outcomes were assessed at the baseline, 4, and 12 weeks.
RESULTS


About 104 patients (56.2%) were diagnosed with OAB and received Mirabegron (50 mg) daily use. Both IPP groups (≤5 and >5 mm) had similar baseline OABSS and International Prostate Symptom Scores (IPSS). Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP ≤5 mm -27.4% and IPP >5 mm -19.7% (P = .419) and IPSS: -32% and -22.5% (P = .202), respectively. Urgency, urge incontinence, and nocturia sub-scores were decreased in both groups, -26.3% and -27.4% (P = .690), 53.3% and 46.2% (P = .916), and 20.8% and 15.4% (P = .958). Effects were maintained at 12 weeks. We found no significant improvement in the frequency sub-score in either group. One patient stopped medication because of intolerable hypertension. Most frequent adverse event was increased residual urine (≥50 mL higher than baseline), IPP ≤5 mm 9.2% and IPP >5 mm 5.1% (P = .707), but no case had acute urinary retention.
CONCLUSIONS


Mirabegron is an effective drug to treat male OAB regardless of IPP grade.",2020,"Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP≤5mm -27.4% and IPP>5mm -19.7% (p=0.419) and IPSS:","['185 male patients ≥ 40 years with lower urinary tract symptoms (LUTS) were recruited from a tertiary referral center', '104 patients (56.2%) were diagnosed with OAB and received', 'male patients with overactive bladder', 'male patients with different degrees of IPP']","['Intravesical prostatic protrusion (IPP', 'Intravesical Prostatic Protrusion', 'Mirabegron']","['IPP', 'OAB', 'Urgency, urge incontinence and nocturia sub-scores', 'frequency sub-score', 'overactive bladder (OAB', 'OAB symptom score urgency score', 'IPSS', 'baseline OAB Symptom Scores and International Prostate Symptom Scores (IPSS']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",185.0,0.0757977,"Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP≤5mm -27.4% and IPP>5mm -19.7% (p=0.419) and IPSS:","[{'ForeName': 'Yuan C', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Hung J', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei C', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Chien H', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Yao C', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}]",International journal of clinical practice,['10.1111/ijcp.13537']
1038,32496397,Early Inflammatory Measures and Neurodevelopmental Outcomes in Preterm Infants.,"BACKGROUND


Inflammation may be an important predictor of long-term neurodevelopment in preterm infants. The identification of specific inflammatory biomarkers that predict outcomes is an important research goal.
OBJECTIVES


The purpose of this analysis was to identify associations between an early measure of inflammation and neurodevelopment in very preterm infants and to identify differences in the relationship between inflammation and neurodevelopment based on infant gender and race.
METHODS


We conducted a secondary analysis of data from a randomized controlled trial of a caregiving intervention for preterm infants born less than 33 weeks postmenstrual age. Plasma was collected with a clinically indicated laboratory draw by neonatal intensive care unit nurses and analyzed by multiplex assay for cytokines, chemokines, and growth factors. Neurobehavior was assessed by research nurses at the time of discharge from the neonatal intensive care unit using the motor development and vigor and alertness/orientation clusters from the Neurobehavioral Assessment of the Preterm Infant. Neurodevelopment was assessed at 6 months corrected age by the developmental specialist in the hospital's neonatal follow-up clinic using the Bayley Scales of Infant Development, Third Edition. We used linear regressions to estimate the effect of cytokine levels on neurodevelopment and allowed the effects to differ by infant gender and race.
RESULTS


In a sample of 62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with 6-month neurodevelopmental assessments, we found inconsistent associations between single-time point inflammatory measures and neurobehavior or neurodevelopment in analyses of the total sample. However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant gender and race.
DISCUSSION


Although early single-time point measures of inflammation may be insufficient to predict neurodevelopment for all preterm infants, the effect of inflammation appears to differ by infant gender and race. These demographic factors may be important considerations for future studies of inflammation and neurodevelopment as well was the development of future interventions to optimize outcomes.",2020,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","['very preterm infants', 'preterm infants born less than 33 weeks post-menstrual age', 'preterm infants', '62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with six month neurodevelopmental assessments']",['caregiving intervention'],[],"[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],62.0,0.0941311,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","[{'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': 'Marliese Dion Nist, PhD, RNC-NIC, is Postdoctoral Scholar, The Ohio State University College of Nursing, Columbus. Abigail B. Shoben, PhD, is Associate Professor, Division of Biostatistics, The Ohio State University College of Public Health, Columbus. Rita H. Pickler, PhD, RN, FAAN, is FloAnn Sours Easton Endowed Professor of Child and Adolescent Health, The Ohio State University College of Nursing, Columbus.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': ''}, {'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000448']
1039,32063157,Nebulised normal saline in moderate acute bronchiolitis and pneumonia in a low- to middle-income country: a randomised trial in Papua New Guinea.,"BACKGROUND


Acute lower respiratory tract infections are the commonest cause of hospitalisation in young children and supportive care remains the cornerstone of management. A randomised open trial was undertaken at the Port Moresby General Hospital Children's Emergency Department (CED) to determine whether nebulised normal saline had beneficial effects.
METHODS


Children <2 years of age presenting with a clinical diagnosis of moderate acute bronchiolitis or moderate pneumonia were randomised to receive standard care alone or with nebulised normal saline administered hourly. The outcomes were the difference in respiratory distress scores (RDS) and oxygen saturation between 0 and 4 hours, and admission rates.
RESULTS


A total of 199 patients participated; 100 patients were randomised to normal saline and 99 to standard care. At 4 hours there was a significant difference in the change of the respiratory distress scores: mean RDS reduced by 3.41 (95% CI 3.0-3.8) in the normal saline group, and for the standard group, the RDS reduced by 1.96 (95% CI 1.5-2.4,  p  < 0.0001). In those receiving normal saline oxygen saturation measured by pulse oximetry (SpO 2 ) increased by a mean of 7% (95% CI 6.0-7.9) to 90.7% at 4 hours. For those receiving standard care, the SpO 2  increased by a mean of 4% (95% CI 2.8-5.2) to 87.5% at 4 hours ( p  < 0.001). Of 100 patients, 58 (58%) in the normal saline group and 24 of 99 (24.2%) in the standard arm were discharged from the Children's Emergency Department ( p  < 0.001).
CONCLUSIONS


This study supports the use of nebulised normal saline in the treatment of moderate acute bronchiolitis or pneumonia in an emergency department setting in a low- to middle-income country.
ABBREVIATIONS


ALRI, acute lower respiratory infection; CED, Children's Emergency Department; NaCl, sodium chloride; PMGH, Port Moresby General Hospital; PNG, Papua New Guinea; RDS, respiratory distress score; SpO 2 , oxygen saturation by pulse oximetry.",2020,In those receiving normal saline oxygen saturation measured by pulse oximetry (SpO 2 ) increased by a mean of 7% (95% CI 6.0-7.9) to 90.7% at 4 hours.,"['moderate acute bronchiolitis or pneumonia in an emergency department setting in a low- to middle-income country', ""Port Moresby General Hospital Children's Emergency Department (CED"", 'moderate acute bronchiolitis and pneumonia in a low- to middle-income country', 'Abbreviations ', '199 patients participated; 100 patients', 'Methods : Children <2\xa0years of age presenting with a clinical diagnosis of moderate acute bronchiolitis or moderate pneumonia']","[' ', 'nebulised normal saline', 'standard care alone or with nebulised normal saline administered hourly', 'normal saline', 'Nebulised normal saline']","['respiratory distress scores: mean RDS', 'pulse oximetry (SpO 2 ', 'RDS', 'respiratory distress scores (RDS) and oxygen saturation between 0 and 4\xa0hours, and admission rates']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0001311', 'cui_str': 'Acute capillary bronchiolitis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0000723', 'cui_str': 'Abbreviations'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}]","[{'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}]",199.0,0.259124,In those receiving normal saline oxygen saturation measured by pulse oximetry (SpO 2 ) increased by a mean of 7% (95% CI 6.0-7.9) to 90.7% at 4 hours.,"[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Pukai', 'Affiliation': 'Paediatrics Department, Port Moresby General Hospital , Port Moresby, Papua New Guinea.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Duke', 'Affiliation': 'Discipline of Child Health, School of Medicine and Health Sciences, University of Papua New Guinea , Port Moresby Papua New Guinea.'}]",Paediatrics and international child health,['10.1080/20469047.2020.1725338']
1040,32499312,The Diet of Higher Insulinemic Potential Is Not Associated with Worse Survival in Patients with Stage III Colon Cancer (Alliance).,"BACKGROUND


Hyperinsulinemia is considered to be important in the development of colon cancer, but few studies have investigated the associations of hyperinsulinemia with colon cancer survival via dietary scores.
METHODS


Empirical dietary index for hyperinsulinemia (EDIH) was derived to assess the insulinemic potential of daily diets reflecting the long-term insulin exposure, with higher (more positive) scores indicating higher insulinemic diets. We prospectively estimated the HRs and 95% confidence intervals (CI) to investigate the association of EDIH with disease-free, recurrence-free, and overall survival among patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803).
RESULTS


Of 1,024 patients (median follow-up: 7.3 years), 311 died, 350 had recurrences, and 394 had events for disease-free survival. Compared with patients in the lowest quintile of EDIH, the corresponding HRs of patients in the highest quintile for disease-free survival events, cancer recurrence, and overall mortality were 0.80 (95% CI, 0.56-1.15), 0.76 (95% CI, 0.51-1.11), and 0.77 (95% CI, 0.52-1.14).
CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of patients with stage III colon cancer.
IMPACT


EDIH, as a measure of dietary insulinemic potential, may be associated with colon cancer risk but not survival in patients with late-stage colon cancer.",2020,"CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","['late stage colon cancer patients', 'Patients with Stage III Colon Cancer (Alliance', 'patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803', 'stage III colon cancer patients']",[],"['hazard ratios (HR', 'risk of colon cancer recurrence or mortality', 'EDIH with disease-free, recurrence-free, and overall survival', 'disease-free survival', 'disease-free survival events, cancer recurrence, and overall mortality']","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",,0.343602,"CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","[{'ForeName': 'En', 'Initials': 'E', 'LastName': 'Cheng', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mullen', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Saltz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Rex B', 'Initials': 'RB', 'LastName': 'Mowat', 'Affiliation': 'Toledo Community Hospital Oncology Program, Toledo, Ohio.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Whittom', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hantel', 'Affiliation': 'Loyola University, Stritch School of Medicine, Naperville, Illinois.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Atienza', 'Affiliation': 'Virginia Oncology Associates, Norfolk, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Messino', 'Affiliation': 'Southeast Cancer Oncology Research Consortium, Mission Hospitals, Asheville, North Carolina.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kindler', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology and Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Epidemiology and Biostatistics and Department of Urology, University of California, San Francisco, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut. charles.fuchs@yale.edu.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1454']
1041,32493506,Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],"['indomethacin and prophylactic pancreatic stent placement', 'Rectal indomethacin']",[],[],"[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C2747855', 'cui_str': 'Pancreatic stent placement'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}]",[],,0.0368255,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Edmundowicz', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Papachristou', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Scheiman', 'Affiliation': 'Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Vargo', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Romagnuolo', 'Affiliation': 'Tidelands Health, Murrels Inlet, SC, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Wood-Williams', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Depue', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04458-0']
1042,32493624,In vitro evaluation of enamel surface roughness and morphology after orthodontic debonding: Traditional cleanup systems versus polymer bur.,"INTRODUCTION


The primary aim of this randomized in vitro study was to compare the effectiveness of carbide, fibreglass and polymer burs on resinous remnant removal after bracket debonding, by the evaluation of enamel surface roughness and morphology. The secondary objective was to compare the time dispended on the procedures.
METHODS


The buccal surfaces of 28 bovine incisors were analysed by a profilometer to initial roughness measurement (Ra-T1). Brackets were bonded with a light-cured resin and debonded with a debonding plier. The samples were randomly divided into four groups, according to the bur used (n=7): A-Tungsten carbide; B-Fibreglass; C-Polymer; D-Polymer with 75% ethanol pre-treatment. The second roughness measurements were made after resin removal (Ra-T2). Time for removal procedures was also recorded. The third measurements were made after polishing (Ra-T3). Scanning Electronic Microscopy was performed in two samples of each group: after resin removal and after polishing. Results of roughness and time measurements were statically analysed by analysis of variance with post-hoc Bonferroni.
RESULTS


After polishing, tungsten carbide (P=0.1555) and fibreglass burs provided final surface roughness statistically similar to the baseline condition (P=1.0000). Yet, polymer burs, associated (P<0.0001) or not to alcohol (P<0.0001), provided surface roughness significantly higher when compared to baseline values. Polymer burs were more time-consuming on resinous remnant removal than tungsten carbide and fibreglass burs (P<0.05).
CONCLUSION


Polymer burs were less effective and more time-consuming to remove the remaining resin than tungsten carbide and fibreglass burs. The polishing step created smoother surfaces regardless of the burs used for resin removal.",2020,"Polymer burs were more time-consuming on resinous remnant removal than tungsten carbide and fibreglass burs (P<0.05).
",[],"['Tungsten carbide; B-Fibreglass; C-Polymer; D-Polymer with 75% ethanol pre-treatment', 'carbide, fibreglass and polymer burs']",[],[],"[{'cui': 'C0077514', 'cui_str': 'tungsten carbide'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0700351', 'cui_str': 'Bur'}]",[],28.0,0.0282465,"Polymer burs were more time-consuming on resinous remnant removal than tungsten carbide and fibreglass burs (P<0.05).
","[{'ForeName': 'Karen Christina', 'Initials': 'KC', 'LastName': 'Soares Tenório', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'Murilo Fernando', 'Initials': 'MF', 'LastName': 'Neupmann Feres', 'Affiliation': 'University of São Paulo, School of Dentistry of Ribeirão Preto, Department of Pediatric Dentistry, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Caio Junji', 'Initials': 'CJ', 'LastName': 'Tanaka', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'Mayara Karolyne Mello', 'Initials': 'MKM', 'LastName': 'Augusto', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'José Augusto', 'Initials': 'JA', 'LastName': 'Rodrigues', 'Affiliation': 'São Judas University, Department of Restorative Dental Sciences, São Paulo, Brazil.'}, {'ForeName': 'Hélio Doyle', 'Initials': 'HD', 'LastName': 'Pereira da Silva', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'Victor Elias', 'Initials': 'VE', 'LastName': 'Arana-Chavez', 'Affiliation': 'University of São Paulo, School of Dentistry, Department of Biomaterials and Oral Biology, São Paulo, Brazil.'}, {'ForeName': 'Marina Guimarães', 'Initials': 'MG', 'LastName': 'Roscoe', 'Affiliation': 'University of São Paulo, School of Dentistry, Department of Biomaterials and Oral Biology, São Paulo, Brazil. Electronic address: marinaroscoe@usp.br.'}]",International orthodontics,['10.1016/j.ortho.2020.04.006']
1043,32497599,"Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial.","OBJECTIVE


To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DESIGN: Prospective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial.
SETTING


Seven university hospitals in the Republic of Korea.
PARTICIPANTS


Patients (N=220) with poststroke upper limb spasticity.
INTERVENTIONS


All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group).
MAIN OUTCOME MEASURES


The primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention.
RESULTS


The primary outcome was found to be -1.32±0.69 and -1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures.
CONCLUSIONS


MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.",2020,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","['post-stroke upper limb spasticity treatment', '220 patients with post-stroke upper limb spasticity', 'Seven university hospitals in the Republic of Korea PARTICIPANTS', 'patients with post-stroke upper limb spasticity DESIGN']","['onabotulinum toxin A (Botox®', 'MT10107 (Coretox group) or onabotulinum toxin A (Botox group', 'MT10107 (Coretox®']","['modified Ashworth scale (MAS', 'adverse events, vital signs, physical examination findings, and laboratory test results', 'Efficacy and safety', 'MAS scores for all muscles and DAS scores', 'response rate, global assessment of treatment, and safety measures', 'change in wrist flexor spasticity', 'efficacy and safety', 'MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",220.0,0.288437,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","[{'ForeName': 'Junekyung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul. Electronic address: mhchun@amc.seoul.kr.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Ko', 'Affiliation': ""Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.""}, {'ForeName': 'Shi-Uk', 'Initials': 'SU', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul.'}, {'ForeName': 'Deog Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam.'}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': 'Department of Rehabilitation Medicine, Dongguk University Ilsan Hospital, Goyang.'}, {'ForeName': 'Yoon Ghil', 'Initials': 'YG', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gangnam Severance Hospital Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.025']
1044,32497736,Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study.,"BACKGROUND


We designed an open-label, noncomparative phase II study to assess the safety and efficacy of first-line treatment with trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B) in untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies.
PATIENTS AND METHODS


From 29 April 2016 to 29 March 2017, 153 patients were randomly assigned (1:1) to either TT-B (N = 77) or C-B (N = 76). The primary end point was progression-free survival (PFS). The primary PFS analysis was performed after 100 events (radiological progression or death) were observed. Secondary end points included overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires), and safety.
RESULTS


Median (range) duration of treatment was 7.8 (6.0-9.7) months and 6.2 (4.1-9.1) months in the TT-B and C-B groups, respectively. Median (range) PFS was 9.2 (7.6-11.6) and 7.8 (5.5-10.1) months, respectively. Median (range) OS was 18 (15.2 to NA) and 16.2 (12.5 to NA) months, respectively. QoL questionnaires showed no relevant changes over time for either treatment. Therapies were well tolerated. Patients receiving TT-B had more grade ≥3 neutropenia (47% versus 5% with C-B). Patients receiving C-B had more grade ≥3 hand-foot syndrome (12% versus 0% with TT-B) and grade ≥3 diarrhea (8% versus 1% with TT-B), consistent with the known safety profiles of these agents.
CONCLUSION


TT-B treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL.
CLINICAL TRIAL INFORMATION


NCT02743221 (ClinicalTrials.gov).",2020,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"['Patients with Untreated Metastatic Colorectal Cancer Ineligible for Intensive Therapy', 'From 29 April 2016 to 29 March 2017', 'untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies', '153 patients']","['Trifluridine/Tipiracil plus Bevacizumab', 'trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B']","['grade ≥3 hand-foot syndrome', 'Median PFS', 'Median OS', 'tolerated', 'overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires) and safety', '100 events (radiological progression or death', 'clinical activity', 'grade ≥3 diarrhea', 'safety and efficacy', 'grade ≥3 neutropenia', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",153.0,0.0974354,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Danielewicz', 'Affiliation': 'Szpitale Wojewodzkie w Gdyni/Gdansk Medical University, Gdynia, Poland.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""Vall d'Hebrón Institute of Oncology and Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'University Hospital Besançon, Besançon, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'C J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Van de Wouw', 'Affiliation': 'VieCuri Medisch Centrum Noord-Limburg, Venlo, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fedyanin', 'Affiliation': 'NN Blokhin National Medical Research Center of Oncology, Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital N62, Moscow, Russia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kroening', 'Affiliation': 'Schwerpunktpraxis für Haematologie und Onkologie Hasselbachplatz, Magdeburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Garcia-Alfonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital of Pisa, Department of Oncology, Pisa, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanehisa', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Egorov', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Aubel', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseenko', 'Affiliation': 'Saint-Petersburg Scientific Practical Center for Specialized Medical Care, St Petersburg, Russia.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.024']
1045,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002']
1046,32504574,"Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.","BACKGROUND


In the primary week-48 analyses of two phase 3 studies, coformulated bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive people with HIV. We report week-144 efficacy and safety results from these studies.
METHODS


We did two double-blind, active-controlled studies (now in open-label extension phase). Study 1 randomly assigned (1:1) HLA-B*5701-negative adults without hepatitis B virus co-infection to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg once daily. Study 2 randomly assigned (1:1) adults to bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg. We previously reported non-inferiority at the primary endpoint. Here, we report the week-144 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the same manner. These studies were registered with ClinicalTrials.gov, NCT02607930 and NCT02607956.
FINDINGS


629 participants were randomly assigned and treated in study 1 (314 to bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study 2 (327 to bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide). At week 144, bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to both dolutegravir-containing regimens for efficacy. In study 1, 256 (82%) of 314 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference -2·6%, 95% CI -8·5 to 3·4). In study 2, 262 (82%) of 320 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (difference -1·9%, -7·8 to 3·9). In both studies, no participant had treatment-emergent resistance to study drugs up to week 144. All treatment regimens were well tolerated with additional exposure. Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2). In study 1, statistically significant differences were observed in median changes from baseline in fasting total cholesterol (14 mg/dL vs 10 mg/dL; p=0·034), direct LDL (21 mg/dL vs 14 mg/dL; p=0·004), and total cholesterol to HDL ratio (-0·1 vs -0·3; p=0·007) at week 144; no differences were observed between groups in study 2. Weight gain was seen across all treatment groups in both studies, with no differences in median changes from baseline in weight at week 144 for either study.
INTERPRETATION


These long-term data support the use of bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people with HIV, with no emergent resistance.
FUNDING


Gilead Sciences.",2020,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","['people with HIV, with no emergent resistance', 'HLA-B*5701-negative adults without hepatitis B virus co-infection', '629 participants were randomly assigned and treated in study 1 (314 to']","['alafenamide', 'coformulated bictegravir, emtricitabine, and tenofovir alafenamide', 'direct LDL', 'bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide', 'tenofovir alafenamide', 'bictegravir, emtricitabine, and tenofovir', 'bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg', 'Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens', 'bictegravir, emtricitabine, and tenofovir alafenamide', 'coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine', 'lamivudine', 'bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine']","['fasting total cholesterol', 'plasma HIV-1 RNA less', 'total cholesterol to HDL ratio', 'Weight gain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0440557', 'cui_str': 'B*5701'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1331249', 'cui_str': 'emtricitabine 200 MG'}, {'cui': 'C4083965', 'cui_str': 'tenofovir alafenamide 25 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4551053', 'cui_str': 'bictegravir 50 MG'}, {'cui': 'C1629814', 'cui_str': 'abacavir 600 MG'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",629.0,0.25769,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK; Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, UK.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario La Paz, IdiPaz Madrid, Spain.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Martorell', 'Affiliation': 'The Research Institute, Springfield, MA, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Stephens', 'Affiliation': 'Department of Internal Medicine, Mercer University School of Medicine, Macon, GA, USA.'}, {'ForeName': 'Hans-Jurgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wohl', 'Affiliation': 'Department of Medicine, Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Unit of HIV-related Diseases and Experimental Therapies, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': 'Infectious Disease Department, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Flamm', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente Medical Group, Sacramento, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Elton John Centre, Royal Sussex County Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30099-0']
1047,32504575,"Population uptake of HIV testing, treatment, viral suppression, and male circumcision following a community-based intervention in Botswana (Ya Tsie/BCPP): a cluster-randomised trial.","BACKGROUND


In settings with high HIV prevalence and treatment coverage, such as Botswana, it is unknown whether uptake of HIV prevention and treatment interventions can be increased further. We sought to determine whether a community-based intervention to identify and rapidly treat people living with HIV, and support male circumcision could increase population levels of HIV diagnosis, treatment, viral suppression, and male circumcision in Botswana.
METHODS


The Ya Tsie Botswana Combination Prevention Project study was a pair-matched cluster-randomised trial done in 30 communities across Botswana done from Oct 30, 2013, to June 30, 2018. 15 communities were randomly assigned to receive HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care. The first primary endpoint of HIV incidence has already been reported. In this Article, we report findings for the second primary endpoint of population uptake of HIV prevention services, as measured by proportion of people known to be HIV-positive or tested HIV-negative in the preceding 12 months; proportion of people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised. A longitudinal cohort of residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates. Differences in intervention uptake over time by randomisation group were tested via paired Student's t test. The study has been completed and is registered with ClinicalTrials.gov (NCT01965470).
FINDINGS


In the six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015. In the same communities, 10 791 (86%) of 12 489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities). At study end, in intervention communities, 1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities. After accounting for baseline differences, at study end the proportion of people living with HIV who were diagnosed was significantly higher in intervention communities (absolute increase of 9% to 93%) compared with standard-of-care communities (absolute increase of 2% to 88%; prevalence ratio [PR] 1·08 [95% CI 1·02-1·14], p=0·032). Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
INTERPRETATION


It is possible to achieve very high population levels of HIV testing and treatment in a high-prevalence setting. Maintaining these coverage levels over the next decade could substantially reduce HIV transmission and potentially eliminate the epidemic in these areas.
FUNDING


US President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.",2020,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
","['In the same communities, 10\u2008791 (86%) of 12\u2008489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities', 'residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates', '15 communities', 'people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised', '30 communities across Botswana done from Oct 30, 2013, to June 30, 2018', 'six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015', '1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities']","['community-based intervention in Botswana (Ya Tsie/BCPP', 'HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care']","['Population levels of ART, viral suppression, and male circumcision']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}]",15.0,0.247072,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
","[{'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Wirth', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA. Electronic address: kathleen.wirth@gmail.com.'}, {'ForeName': 'Tendani', 'Initials': 'T', 'LastName': 'Gaolathe', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Pretorius Holme', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mompati', 'Initials': 'M', 'LastName': 'Mmalane', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Kadima', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Unoda', 'Initials': 'U', 'LastName': 'Chakalisa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlo', 'Initials': 'K', 'LastName': 'Manyake', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Atang', 'Initials': 'A', 'LastName': 'Matildah Mbikiwa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Selebaleng V', 'Initials': 'SV', 'LastName': 'Simon', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Letlhogile', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlwano', 'Initials': 'K', 'LastName': 'Mukokomani', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Widenfelt', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Sikhulile', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Bennett Statistical Consulting, Ballston Lake, NY, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Leidner', 'Affiliation': 'Goodtables Data Consulting, Norman, Oklahoma, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Powis', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Mary Grace', 'Initials': 'MG', 'LastName': 'Alwano', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Dryden-Peterson', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Coulson', 'Initials': 'C', 'LastName': 'Kgathi', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Raizes', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abrams', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA; Intellectual Concepts, Atlanta, GA, USA.'}, {'ForeName': 'Baraedi', 'Initials': 'B', 'LastName': 'Sento', 'Affiliation': 'Tebelopele Voluntary Counseling and Testing Center, Gaborone, Botswana.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Novitsky', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Shenaaz', 'Initials': 'S', 'LastName': 'El-Halabi', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Tafireyi', 'Initials': 'T', 'LastName': 'Marukutira', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mills', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Sexton', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Pals', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Shapiro', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Essex', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Tchetgen Tchetgen', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Department of Statistics, The Wharton School at the University of Pennsylvania, Philadelphia, PA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30103-X']
1048,32508277,"A randomized controlled pilot study evaluating  Worry Less, Live More: The Mindful Way Through Anxiety Workbook .","Effective interventions for generalized anxiety exist, but barriers to treatment prevent their broad dissemination. Commercially available self-help materials may help bridge this gap, but few have been empirically evaluated. This study compared self-reported change in generalized anxiety symptomology and associated problems between community members with excessive worry who were randomly assigned to receive the  Worry Less, Live More: The Mindful Way through Anxiety Workbook  ( n  = 35) and those in a delayed condition ( n  = 29). Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η   2  =.15), general anxiety/tension ( η   2  =.13), and anxiety ( η   2  =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected. This pilot study provides support for continued research examining the efficacy of acceptance-based behavioral therapy delivered in a self-help format.",2020,"Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η   2  =.15), general anxiety/tension ( η   2  =.13), and anxiety ( η   2  =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected.","['community members with excessive worry', 'Worry Less, Live More']",['acceptance-based behavioral therapy'],"['depression, functional impairment or acceptance', 'generalized anxiety symptomology', 'general anxiety/tension', 'anxiety']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",,0.0306532,"Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η   2  =.15), general anxiety/tension ( η   2  =.13), and anxiety ( η   2  =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected.","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'Psychology Service, VA Connecticut Healthcare System, Department of Psychiatry, Yale University School of Medicine , New Haven, CT, USA.'}, {'ForeName': 'Lizabeth', 'Initials': 'L', 'LastName': 'Roemer', 'Affiliation': 'Psychology Department, University of Massachusetts , Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Suvak', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Liverant', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Orsillo', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1765858']
1049,32505193,Exercise training alone or in combination with high-protein diet in patients with late onset Pompe disease: results of a cross over study.,"BACKGROUND


Late onset Pompe disease (LOPD) is a lysosomal neuromuscular disorder which can progressively impair the patients' exercise tolerance, motor and respiratory functions, and quality of life. The available enzyme replacement therapy (ERT) does not completely counteract disease progression. We investigated the effect of exercise training alone, or associated with a high-protein diet, on the exercise tolerance, muscle and pulmonary functions, and quality of life of LOPD patients on long term ERT.
METHODS


The patients were asked to participate to a crossover randomized study comprehending a control period (free diet, no exercise) followed by 2 intervention periods: exercise or exercise + diet, each lasting 26 weeks and separated by 13 weeks washout periods. Exercise training included moderate-intensity aerobic exercise on a cycle ergometer, stretching and balance exercises, strength training. The diet was composed by 25-30% protein, 30-35% carbohydrate and 35-40% fat. Before and after each period patients were assessed for: exercise tolerance test on a cycle-ergometer, serum muscle enzymes, pulmonary function tests and SF36 questionnaire for quality of life. Compliance was evaluated by training and dietary diaries. Patients were contacted weekly by researchers to optimize adherence to treatments.
RESULTS


Thirteen LOPD patients, median age 49 ± 11 years, under chronic ERT (median 6.0 ± 4.0 years) were recruited. Peak aerobic power (peak pulmonary O 2  uptake) decreased after control, whereas it increased after exercise, and more markedlyafter exercise + diet. Serum levels of lactate dehydrogenase (LDH) significantly decreased after exercise + diet; both creatine kinase (CK) and LDH levels were significantly reduced after exercise + diet compared to exercise. Pulmonary function showed no changes after control and exercise, whereas a significant improvement of forced expiratory volume in 1 sec (FEV1) was observed after exercise + diet. SF36 showed a slight improvement in the ""mental component"" scale after exercise, and a significant improvement in ""general health"" and ""vitality"" after exercise + diet. The compliance to prescriptions was higher than 70% for both diet and exercise.
CONCLUSIONS


Exercise tolerance (as evaluated by peak aerobic power) showed a tendency to decrease in LOPD patients on long term ERT. Exercise training, particularly if combined with high-protein diet, could reverse this decrease and result in an improvement, which was accompanied by improved quality of life. The association of the two lifestyle interventions resulted also in a reduction of muscle enzyme levels and improved pulmonary function.",2020,Serum levels of lactate dehydrogenase (LDH) significantly decreased after exercise + diet; both creatine kinase (CK) and LDH levels were significantly reduced after exercise + diet compared to exercise.,"['Thirteen LOPD patients, median age 49\u2009±\u200911\u2009years, under chronic ERT (median 6.0\u2009±\u20094.0\u2009years) were recruited', 'patients with late onset Pompe disease']","['exercise training alone', 'Exercise training', 'enzyme replacement therapy (ERT', 'control period (free diet, no exercise) followed by 2 intervention periods: exercise or exercise\u2009+\u2009diet', 'Exercise training alone or in combination with high-protein diet', 'Exercise training included moderate-intensity aerobic exercise on a cycle ergometer, stretching and balance exercises, strength training']","['quality of life', 'exercise tolerance test on a cycle-ergometer, serum muscle enzymes, pulmonary function tests and SF36 questionnaire for quality of life', 'general health"" and ""vitality', 'Peak aerobic power (peak pulmonary O 2  uptake', 'Serum levels of lactate dehydrogenase (LDH', 'exercise tolerance, muscle and pulmonary functions, and quality of life', 'mental component"" scale', 'creatine kinase (CK) and LDH levels', 'muscle enzyme levels and improved pulmonary function', 'forced expiratory volume in 1 sec (FEV1']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0342753', 'cui_str': 'Glycogen storage disease due to acid maltase deficiency, late-onset'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141895', 'cui_str': 'Muscle enzyme'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",13.0,0.0120145,Serum levels of lactate dehydrogenase (LDH) significantly decreased after exercise + diet; both creatine kinase (CK) and LDH levels were significantly reduced after exercise + diet compared to exercise.,"[{'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Sechi', 'Affiliation': 'Regional Coordinator Center for Rare Diseases, Academic hospital of Udine, p.zzale SM della Misericordia 15, 33100, Udine, Italy. annalisa.sechi@asufc.sanita.fvg.it.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Zuccarelli', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Grassi', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Frangiamore', 'Affiliation': 'Neuroimmunology and Muscle Pathology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'De Amicis', 'Affiliation': 'International Center for the Assessment of Nutritional Status (ICANS), Department of Food Environmental and Nutritional Sciences (DeFENS), University of Milan, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Marzorati', 'Affiliation': 'Institute of Biomedical Technologies, National Research Council, Segrate, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Porcelli', 'Affiliation': 'Institute of Biomedical Technologies, National Research Council, Segrate, Italy.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Tullio', 'Affiliation': 'Institute of Hygiene and Clinical Epidemiology, Academic hospital of Udine, Udine, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bacco', 'Affiliation': 'Division of Endocrinology, Metabolic Diseases and Nutrition, Academic Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bertoli', 'Affiliation': 'International Center for the Assessment of Nutritional Status (ICANS), Department of Food Environmental and Nutritional Sciences (DeFENS), University of Milan, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dardis', 'Affiliation': 'Regional Coordinator Center for Rare Diseases, Academic hospital of Udine, p.zzale SM della Misericordia 15, 33100, Udine, Italy.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Biasutti', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Maria Barbara', 'Initials': 'MB', 'LastName': 'Pasanisi', 'Affiliation': 'Neuroimmunology and Muscle Pathology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Devigili', 'Affiliation': 'Neurological Unit 1, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bembi', 'Affiliation': 'Regional Coordinator Center for Rare Diseases, Academic hospital of Udine, p.zzale SM della Misericordia 15, 33100, Udine, Italy.'}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01416-6']
1050,32513192,"Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda.","BACKGROUND


Despite initial high motivation, individuals receiving antiretroviral therapy (ART) for several years may experience incomplete adherence over time, increasing their risk of HIV-related morbidity and mortality. Habits, defined as automatic and regular practices, do not rely on conscious effort, and may therefore support high long-term ART adherence.
METHODS


This qualitative study contributes to the evidence on how clients with adherence problems remember and form habits to take ART medications. Free-listing and unstructured interviewing were used among 42 clinic-enrolled adults in Kampala, Uganda who were receiving ART and participating in a randomized clinical trial for treatment adherence (clinicaltrials.gov: NCT03494777). Data were coded and analyzed using inductive content analysis.
RESULTS


Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times. Efforts to improve ART habits included having a relative to ask about pill-taking, re-packaging medications, leaving medications in view, using alarms, carrying water, or linking pill-taking to radio/prayer schedules. Reported challenges were adhering to ART schedules during changing employment hours, social activities, and travel.
CONCLUSION


While habit-forming interventions have the potential to improve ART adherence, targeting treatment-mature clients' existing routines may be crucial in this population.",2020,"RESULTS


Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times.","['clinic-enrolled HIV-infected adults', '42 clinic-enrolled adults in Kampala, Uganda who were receiving']","['ART', 'Free-listing and unstructured interviewing', 'antiretroviral therapy (ART']",[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",[],,0.0592003,"RESULTS


Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times.","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Department of Applied Health Science, Center for Sexual Health Promotion, 1025 E. 7th Street, Bloomington, IN, USA. ljmayowi@iu.edu.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Devoto', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of International Health, Social and Behavioral Interventions Program, 615\xa0N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of International Health, Social and Behavioral Interventions Program, 615\xa0N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Mildmay Hospital and Institute of Health Sciences, Box 24985, Kampala, Uganda.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Shelton', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of International Health, Social and Behavioral Interventions Program, 615\xa0N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacCarthy', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}, {'ForeName': 'Uzaib', 'Initials': 'U', 'LastName': 'Saya', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Mildmay Uganda, Mildmay Hospital and Institute of Health Sciences, Box 24985, Kampala, Uganda.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00283-2']
1051,32513646,Development and Preliminary Evaluation of the Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.,"BACKGROUND


Pulmonary rehabilitation is one of the main interventions to reduce the use of health resources, and it promotes a reduction in chronic obstructive pulmonary disease (COPD) costs. mHealth systems in COPD aim to improve adherence to maintenance programs after pulmonary rehabilitation by promoting the change in attitude and behavior necessary for patient involvement in the management of the disease.
OBJECTIVE


This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied after pulmonary rehabilitation in COPD patients.
METHODS


COPD patients from three hospitals were randomized to a control group or an intervention group (HappyAir group). Patients from both groups received an 8-week program of pulmonary rehabilitation and educational sessions about their illness. After completion of the process, only the HappyAir group completed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The control group only underwent the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary Disease Assessment Test, St. George's Respiratory Questionnaire, and EuroQOL-5D), exercise capacity (6-Minute Walk Test), and lung function.
RESULTS


In total, 44 patients were recruited and randomized in the control group (n=24) and HappyAir group (n=20). Eight patients dropped out for various reasons. The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HappyAir group, which was statistically different compared with the control group at 12 months (56.1 [SD 4.0] vs 44.0 [SD 13.6]; P=.004) after pulmonary rehabilitation.
CONCLUSIONS


mHealth systems designed for COPD patients improve adherence to maintenance programs as long as they are accompanied by disease awareness and patient involvement in management.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04479930; https://clinicaltrials.gov/ct2/show/NCT04479930.",2020,"The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR.
","['44 patients were recruited and randomized in the CG (n=24) and HG (n=20', 'COPD patients from three hospitals', 'COPD patients', 'COPD Patients']","['control group (CG) or an intervention group (HappyAir™ group [HG', 'mHealth Web-based Platform (HappyAir™', 'integrated care plan based on an mHealth web-based platform (HappyAir™', 'Maintenance Program', 'Pulmonary rehabilitation (PR']","['adherence to physical activity (Morisky-Green Test), quality of life (CAT, SGRQ and EuroQOL-5D), exercise capacity (6MWT) and lung function', 'adherence', 'Adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",44.0,0.0421553,"The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR.
","[{'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Jiménez-Reguera', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Maroto López', 'Affiliation': 'Lovexair Foundation, Madrid, Spain.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Fitch', 'Affiliation': 'Lovexair Foundation, Madrid, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Juarros', 'Affiliation': 'Hospital Universitario 12 de octubre, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sánchez Cortés', 'Affiliation': 'Hospital Universitario 12 de octubre, Madrid, Spain.'}, {'ForeName': 'Juan Luis', 'Initials': 'JL', 'LastName': 'Rodríguez Hermosa', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Calle Rubio', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Hernández Criado', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Angulo-Díaz-Parreño', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Vilaró', 'Affiliation': 'Ramon Llull University, Barcelona, Spain.'}]",JMIR mHealth and uHealth,['10.2196/18465']
1052,32516725,"Inflammatory cytokines and DNA methylation in healthy young adults exposure to fine particulate matter: A randomized, double-blind crossover trial of air filtration.","Benefits of indoor air filtration in heavily polluted areas are not fully understood. This study aims to examine whether short-term air filtration intervention could attenuate the hazards from acute exposure to fine particulate matter (PM 2.5 ), and investigate the potential impact on inflammatory cytokines and DNA methylation. A randomized, double-blind crossover trial of true or sham indoor air filtration was conducted among 29 healthy young adults in Beijing, China. Each episode covered a typical air pollution wave, and 38 cytokines and DNAm of 20 genes were measured at 3 time points: pre-smog, during smog, and post-smog. Linear mixed-effect models were used to evaluate the associations. The indoor PM 2.5  concentration with true filtration was 67.8 % lower than sham filtration (13.8 μg/m 3 vs. 42.8 μg/m 3 ). Air filtration was significantly associated with the decreases in 9 cytokines, from 6.61 % to 21.24 %. PM 2.5  exposure was significantly associated with elevated levels of 9 cytokines and changed methylation at 7 CpG sites. Notably, PM 2.5  was significantly associated with GM-CSF, sCD40L, MCP-1, and FGF-2, as well as methylation in corresponding genes, but no mediation effect was observed. This trial suggested that indoor air filtration might attenuate the adverse effects of PM 2.5  exposure through changing cytokines and DNAm.",2020,The indoor PM 2.5  concentration with true filtration was 67.8 % lower than sham filtration (13.8 μg/m 3,"['29 healthy young adults in Beijing, China', 'healthy young adults exposure to fine particulate matter']","['short-term air filtration intervention', 'sham indoor air filtration']","['GM-CSF, sCD40L, MCP-1, and FGF-2', 'Air filtration', 'Inflammatory cytokines and DNA methylation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}]",29.0,0.181912,The indoor PM 2.5  concentration with true filtration was 67.8 % lower than sham filtration (13.8 μg/m 3,"[{'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Qisijing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Chunyue', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Yunyi', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Bingxiao', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Kuo', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China; Key Laboratory of Molecular Cardiovascular Sciences of Ministry of Education, Peking University Health Science Center, Beijing, 100191, PR China. Electronic address: shaowei_wu@bjmu.edu.cn.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China. Electronic address: zlilyepi@ccmu.edu.cn.'}]",Journal of hazardous materials,['10.1016/j.jhazmat.2020.122817']
1053,32516744,Evaluation of factors influencing obesity and the effect of a 12-week home-based exercise program in people with epilepsy - Randomized control trial.,"BACKGROUND


Association of obesity, quality of life (QoL), and physical fitness in people with epilepsy (PWE) is rarely reported. We evaluate the effect of a 12-week home-based exercise program on weight reduction and physical capacity in PWE.
METHODS


In 173 PWE, physical fitness was assessed by using six-minute walk test (6MWT) and one-minute step test. Self-reported QoL data was collected using a 12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores were derived. Effect of exercise was evaluated using randomized study of 110 PWE, divided into control and exercise groups of 55 each.
RESULTS


At baseline, mean age of study population was 25.85 ± 9.62 years with 77 (44.5%) women. Average body mass index (BMI) was 29.33 ± 6.17 kg/m 2 . Mean PCS and MCS were 45.95 ± 7.92 and 45.72 ± 10.40 respectively. In 124 (71.7%) PWE with obesity, while high-density lipoprotein (HDL-C) (46.10 ± 12.32 vs. 39.30 ± 10.39 mg/dL; p < .001) was lower, low-density lipoprotein (LDL-C) (101.60 ± 37.51 vs. 113.89 ± 32.65 mg/dL; p = .035) was high. Both the randomized groups were comparable for type and number of antiepileptic drugs (AEDs) used. At 12-week follow-up, PWE in the exercise group reduced 7.65 ± 5.62 kg while control group gained an average of 4.01 ± 4.74 kg (p < .001). Distance walked in 6MWT (293.07 ± 118.73 vs. 464.29 ± 55.33 m; p = .007) and PCS (48.59 ± 8.57 vs. 52.62 ± 4.03; p = .006) were higher in exercise group whereas MCS did not differ between the groups. None of the participants reported seizure during the 12-week follow-up period.
CONCLUSION


People with epilepsy have low PCS and MCS scores; PWE with obesity have altered metabolic profile when compared to PWE without obesity. A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used. Trials with larger sample size and longer follow-up are required to validate our findings.",2020,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","['110 PWE, divided into control and exercise groups of 55 each', 'people with epilepsy - Randomized control trial', 'At baseline, mean age of study population was 25.85\u202f±\u202f9.62\u202fyears with 77 (44.5%) women', 'people with epilepsy (PWE']",['home-based exercise program'],"['12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores', 'Average body mass index (BMI', 'physical fitness', 'Distance walked in 6MWT', 'weight and improves physical capacity', 'weight reduction and physical capacity', 'Mean PCS and MCS', 'low-density lipoprotein (LDL-C']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0800908,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","[{'ForeName': '', 'Initials': '', 'LastName': 'SudhindraVooturi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India. Electronic address: sudhindragupta@gmail.com.'}, {'ForeName': 'A N R', 'Initials': 'ANR', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Physiology, Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar, Telangana, India.'}, {'ForeName': 'Sita', 'Initials': 'S', 'LastName': 'Jayalakshmi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107148']
1054,32520897,"Dynamic impact of transfusion ratios on outcomes in severely injured patients: Targeted machine learning analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios randomized clinical trial.","BACKGROUND


Massive transfusion protocols to treat postinjury hemorrhage are based on predefined blood product transfusion ratios followed by goal-directed transfusion based on patient's clinical evolution. However, it remains unclear how these transfusion ratios impact patient outcomes over time from injury.
METHODS


The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) is a phase 3, randomized controlled trial, across 12 Level I trauma centers in North America. From 2012 to 2013, 680 severely injured patients required massive transfusion. We used semiparametric machine learning techniques and causal inference methods to augment the intent-to-treat analysis of PROPPR, estimating the dynamic relationship between transfusion ratios and outcomes: mortality and hemostasis at different timepoints during the first 24 hours after admission.
RESULTS


In the intention-to-treat analysis, the 1:1:1 group tended to have decreased mortality, but with no statistical significance. For patients in whom hemostasis took longer than 2 hours, the 1:1:1 ratio was associated with a higher probability of hemostasis, statistically significant from the 4 hour on. In the per-protocol, actual-transfusion-ratios-received analysis, during four successive time intervals, no significant association was found between the actual ratios and mortality. When comparing patient groups who received both high plasma/PRBC and high platelet/PRBC ratios to the group of low ratios in both, the relative risk of achieving hemostasis was 2.49 (95% confidence interval, 1.19-5.22) during the third hour after admission, suggesting a significant beneficial impact of higher transfusion ratios of plasma and platelets on hemostasis.
CONCLUSION


Our results suggest that the impact of transfusion ratios on hemostasis is dynamic. Overall, the transfusion ratios had no significant impact on mortality over time. However, receiving higher ratios of platelets and plasma relative to red blood cells hastens hemostasis in subjects who have yet to achieve hemostasis within 3 hours after hospital admission.
LEVEL OF EVIDENCE


Therapeutic IV.",2020,"Overall, the transfusion ratios had no significant impact on mortality over time.","['680 severely injured patients required massive transfusion', 'Severely Injured Patients', '12 level-I trauma centers in North America']",['Transfusion Ratios'],"['relative risk of achieving hemostasis', 'mortality', 'probability of hemostasis', 'actual ratios and mortality']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",680.0,0.326126,"Overall, the transfusion ratios had no significant impact on mortality over time.","[{'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'From the Division of Epidemiology and Biostatistics (M.N., J.C., A.H.), School of Public Health, University of California, Berkeley; Department of Anesthesia and Perioperative Care (R.P.), Department of Surgery (L.Z.K., R.C.), School of Medicine, University of California, San Francisco, California; Division of Acute Care Surgery, Department of Surgery (E.E.F.), Medical School, Center for Translational Injury Research, Department of Surgery (C.E.W., J.B.H.), Center for Translational Injury Research, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine (M.S.), Oregon Health & Science University, Portland, Oregon; and Department of Surgery, School of Medicine (M.C.), University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pirracchio', 'Affiliation': ''}, {'ForeName': 'Lucy Z', 'Initials': 'LZ', 'LastName': 'Kornblith', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Callcut', 'Affiliation': ''}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Coyle', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hubbard', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002819']
1055,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1056,32524827,An integrated videoconferencing intervention for chronic pain and heavy drinking among patients in HIV-care: a proof-of-concept study.,"Chronic pain and heavy drinking are common comorbid conditions among people living with HIV/AIDS (PLWHA). An integrated approach to address these co-occurring conditions in a manner that facilitates treatment utilization would represent an important advance in HIV-care. This study examined the acceptability and feasibility of a tailored, videoconferencing intervention to reduce chronic pain and heavy drinking among PLWHA. Participants in HIV-care (n = 8) completed baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions. Acceptability and feasibility were assessed with patient satisfaction ratings and interview responses 8 weeks following baseline along with videoconferencing use during the intervention period. Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format. All participants successfully enabled videoconferencing on their own smartphones and completed a median number of 4.5 (out of 6) video-sessions. Changes in heavy drinking and pain provided additional support for the potential utility of this approach. Results suggest that this videoconferencing intervention is an acceptable and feasible method of addressing chronic pain and heavy drinking among PLWHA. Findings provide the basis for future work to examine the efficacy of this approach in a Stage 1b trial.",2020,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","['patients in HIV-care', 'Participants in HIV-care (n\u2009=\u20098) completed', 'people living with HIV/AIDS (PLWHA']","['integrated videoconferencing intervention', 'baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions', 'videoconferencing intervention']","['Acceptability and feasibility', 'chronic pain and heavy drinking', 'Chronic pain and heavy drinking', 'Treatment satisfaction and comprehensibility ratings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0421099,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","[{'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Maya P L', 'Initials': 'MPL', 'LastName': 'Kratzer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Otis', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",AIDS care,['10.1080/09540121.2020.1776825']
1057,31854221,Sparing the pronator quadratus for volar plating of distal radius fractures: a comparative study of two methods.,"OBJECTIVES


The objective of this study was to compare the results of two methods for sparing the pronator quadratus in volar plating of distal radius fractures.
METHODS


A total of 110 patients were randomized to volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method (Group B, 55 people). The operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications were recorded.
RESULTS


There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups. We found no significant differences in range of motion, grip strength, VAS scores, and DASH scores at any of the study intervals between the groups. Although neurapraxia of the superficial branch of the radial nerve was more common in Group B than in Group A (6.7% vs. 0%), the difference was not significant.
CONCLUSIONS


Both methods were efficient approaches for sparing the pronator quadratus and had similar clinical outcomes, but they had different indications.",2020,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","['110 patients', 'distal radius fractures']","['volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method']","['range of motion, grip strength, VAS scores, and DASH scores', 'mean operative time, radiation time, mean bone union time, or total complication rate', 'operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C1261209', 'cui_str': 'Transverse incision'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0224264', 'cui_str': 'Structure of brachioradialis muscle'}, {'cui': 'C1444777', 'cui_str': 'Splitting sensation quality'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",110.0,0.0516226,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Yun-Qiang', 'Initials': 'YQ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Gang-Qiang', 'Initials': 'GQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ya-Di', 'Initials': 'YD', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060519893851']
1058,32526771,Criteria for the determination of maximal oxygen uptake in patients newly diagnosed with cancer: Baseline data from the randomized controlled trial of physical training and cancer (Phys-Can).,"INTRODUCTION


Maximal oxygen uptake ([Formula: see text]) is a measure of cardiorespiratory fitness often used to monitor changes in fitness during and after treatment in cancer patients. There is, however, limited knowledge in how criteria verifying [Formula: see text] work for patients newly diagnosed with cancer. Therefore, the aim of this study was to describe the prevalence of fulfillment of typical criteria verifying [Formula: see text] and to investigate the associations between the criteria and the test leader's evaluation whether a test was performed ""to exhaustion"". An additional aim was to establish new cut-points within the associated criteria.
METHODS


From the Phys-Can randomized controlled trial, 535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an incremental [Formula: see text] test on a treadmill. The test was performed before starting (neo-)adjuvant treatment and an exercise intervention. Fulfillment of different cut-points within typical criteria verifying [Formula: see text] was described. The dependent key variables included in the initial bivariate analysis were achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR). A receiver operating characteristic analysis was performed to establish cut-points for variables associated with the test leader's evaluation. Last, a cross-validation of the cut-points found in the receiver operating characteristic analysis was performed on a comparable sample of cancer patients (n = 80).
RESULTS


The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"". The cut-points that best predicted the test leader's evaluation were RER ≥ 1.14, RPE ≥ 18 and fR ≥ 40. Maximal heart rate and [Formula: see text] plateau was not associated with the test leader's evaluation.
CONCLUSION


We recommend a focus on RER (in the range between ≥1.1 and ≥1.15) and RPE (≥17 or ≥18) in addition to the test leader's evaluation. Additionally, a fR peak of ≥40 breaths/min may be a cut-point to help the test leader evaluate the degree of exhaustion. However, more research is needed to verify our findings, and to investigate how these criteria will work within a population that are undergoing or finished with cancer treatment.",2020,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","['535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an', 'cancer patients', 'patients newly diagnosed with cancer']","['incremental [Formula: see text] test on a treadmill', 'physical training and cancer (Phys-Can']","[""achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR"", 'fR peak', 'Maximal heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",535.0,0.0740939,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","[{'ForeName': 'Ann Christin Helgesen', 'Initials': 'ACH', 'LastName': 'Bjørke', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}]",PloS one,['10.1371/journal.pone.0234507']
1059,32682992,Characterizing the analgesic effects of real and imagined acupuncture using functional and structure MRI.,"Acupuncture and imagery interventions for pain management have a long history. The present study comparatively investigated whether acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture on the participant's own body while imagining it being applied) could modulate brain regional connectivity to produce analgesic effects. The study also examined whether pre-intervention brain functional and structural features could be used to predict the magnitude of analgesic effects. Twenty-four healthy participants were recruited and received four different interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control) in random order using a cross-over design. Pain thresholds and magnetic resonance imaging (MRI) data were collected before and after each intervention. We first compared the modulatory effects of real acupuncture and VGAIT on intra- and inter-regional intrinsic brain connectivity and found that real acupuncture decreased regional homogeneity (ReHo) and functional connectivity (FC) in sensorimotor areas, whereas VGAIT increased ReHo in basal ganglia (BG) (i.e., putamen) and FC between the BG subcortical network and default mode network. The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively. A multimodality fusion approach with pre-intervention ReHo and gray matter volume (GMV) as features was used to explore the brain profiles underlying individual variability of pain threshold changes by real acupuncture and VGAIT. Variability in acupuncture responses was associated with ReHo and GMV in BG, whereas VGAIT responses were associated with ReHo and GMV in the anterior insula. These results suggest that, through different pathways, both real acupuncture and VGAIT can modulate brain systems to produce analgesic effects.",2020,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.",['Twenty-four healthy participants'],"['real acupuncture and VGAIT', 'acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture', 'pre-intervention ReHo and grey matter volume (GMV', 'interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control', 'Acupuncture and imagery interventions']","['pain threshold', 'Pain thresholds and magnetic resonance imaging (MRI) data', 'regional homogeneity (ReHo) and functional connectivity (FC']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",24.0,0.0799386,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States; Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States. Electronic address: jkong2@mgh.harvard.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117176']
1060,32532328,Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham.,"BACKGROUND


People with chronic low back pain (LBP) typically have increased pain sensitivity compared to healthy controls, however its unknown if pain sensitivity differs based on LBP trajectory at baseline or after manual therapy interventions. We aimed to compare baseline pressure pain threshold (PPT) and temporal summation (TS) between people without LBP, with episodic LBP, and with persistent LBP, and to compare changes over time in PPT and TS after a lumbar spinal manipulation or sham manipulation in those with LBP.
METHODS


Participants were aged 18-59, with or without LBP. Those with LBP were categorised as having either episodic or persistent LBP. PPT and TS were tested at baseline. LBP participants then received a lumbar spinal manipulation or sham, after which PPT and TS were re-tested three times over 30 min. Generalised linear mixed models were used to analyse data.
RESULTS


One hundred participants (49 female) were included and analysed. There were 20 non-LBP participants (mean age 31 yrs), 23 episodic LBP (mean age 35 yrs), and 57 persistent LBP (mean age 37 yrs). There were no significant differences in PPT or TS between groups at baseline. There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability. Changes in PPT and TS after the interventions did not differ between the two LBP groups.
DISCUSSION


We found no differences between people with no LBP, episodic LBP, or persistent LBP in baseline PPT or TS. Changes in PPT and TS following a lumbar manual therapy intervention do not appear to differ between LBP trajectories.
TRIAL REGISTRATION


The trial was prospectively registered with ANZCTR (ACTRN12617001094369).",2020,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","['people without LBP, with episodic LBP, and with persistent LBP', 'One hundred participants (49 female) were included and analysed', 'Participants were aged 18-59, with or without LBP', '20 non-LBP participants (mean age 31\u2009yrs), 23 episodic LBP (mean age 35\u2009yrs), and 57 persistent LBP (mean age 37\u2009yrs', 'adults with episodic and persistent low back pain trajectories', 'People with chronic low back pain (LBP']","['LBP', 'lumbar spinal manipulation']","['PPT or TS', 'pain sensitivity', 'Pressure pain threshold and temporal summation', 'baseline pressure pain threshold (PPT) and temporal summation (TS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0443150', 'cui_str': 'Baseline pressure'}]",100.0,0.151039,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia. sasha.aspinall@murdoch.edu.au.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00326-5']
1061,32534120,Effect of traditional Chinese medicine formula GeGen decoction on primary dysmenorrhea: A randomized controlled trial study.,"ETHNOPHARMACOLOGICAL RELEVANCE


GeGen Decoction, a well-known Chinese herbal formula, is widely used in China and other Asian countries to treat gynecological diseases, including primary dysmenorrhea. Pharmacological studies have confirmed that GeGen Decoction is able to inhibit spasmodic contractions of the uterus in vivo and in vitro.
AIM OF THE STUDY


The objective of this study is to examine the efficacy and safety of GeGen Decoction on primary dysmenorrheic patients.
METHODS


This was a randomized, double-blinded, placebo-controlled trial. GeGen Decoction or placebo was administered a week before the expected start of each cycle for three consecutive menstrual periods. Between-group differences in pain intensity were detected by visual analogue scale (VAS). In addition, serum levels of arginine vasopressin (AVP) and estrogen (E) were examined by enzyme-linked immunosorbent assay. Metabolomic analysis was further used to evaluate the influence of GeGen Decoction on the metabolomics of primary dysmenorrheic patients.
RESULTS


A total of 71 primary dysmenorrheic women were recruited and 30 participants met the criteria were randomized into GeGen Decoction or placebo group. After three consecutive menstrual cycles' treatments, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group. Both serum levels of AVP and E decreased after GeGen Decoction administration, while the placebo seemed to have little effect on either of the index. Moreover, after GeGen Decoction treatment, seven important metabolites were identified by metabolomic analysis compared to the placebo group. No abnormalities in blood biochemical and routine physical examination pre and post GeGen Decoction intervention were observed.
CONCLUSIONS


GeGen Decoction can remarkably relieve the severity of menstrual pain without obvious adverse effects. Its therapeutic effect on primary dysmenorrhea might be related to the regulation of pituitary hypothalamic ovarian hormones, and interfering with the metabolic change.",2020,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","['primary dysmenorrhea', 'primary dysmenorrheic patients', '71 primary dysmenorrheic women were recruited and 30 participants met the criteria']","['GeGen Decoction', 'traditional Chinese medicine formula GeGen decoction', 'GeGen Decoction or placebo', 'placebo']","['VAS score', 'pain intensity', 'blood biochemical and routine physical examination pre and post GeGen Decoction intervention', 'visual analogue scale (VAS', 'serum levels of arginine vasopressin (AVP) and estrogen (E', 'serum levels of AVP and E', 'efficacy and safety', 'severity of menstrual pain']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",71.0,0.369829,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","[{'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Shanxi University, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Hospital Affiliated to Shanxi University of Traditional Chinese Medicine, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China. Electronic address: liuzhigang729@seu.edu.cn.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China. Electronic address: boyangyu59@163.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113053']
1062,32494769,Comparison of ovulation induction with letrozole plus dexamethasone and letrozole alone in infertile women with polycystic ovarian disease: An RCT.,"Background


Infertility is characterized by the inability to obtain a successful pregnancy after 6 months or more with unprotected and regular intercourse. In developing countries, the incidence of infertility is 2%. The causes of infertility could be male factor or female factor, or mixed factor.
Objective


This study was conducted with the aim of comparison the ovarian response to letrozole alone and letrozole plus dexamethasone in infertile women with poly cystic ovarian disease (PCOS).
Materials and Methods


This randomized clinical trial was conducted on 120 infertile women with PCOS referred to Ali-Ebne-Abitaleb hospital, Zahedan, Iran from February to August 2017 into two groups: group I received letrozole alone and group II recived letrozole plus dexamethasone. The endometrial thickness, follicle diameter, and ovulation were evaluated and compared by ultrasound on days 12 to 14.
Results


The mean thickness of endometrium was not different between two groups. Pregnancy rate was 8% in letrozole group and 23% in Letrozole plus Dexamethasone (p = 0.024). Also, the mean diameter of follicles in two groups were not statistically significant.
Conclusion


Overall, this study showed that dexamethasone may increase pregnancy rate.",2020,Pregnancy rate was 8% in letrozole group and 23% in Letrozole plus Dexamethasone (p = 0.024).,"['infertile women with polycystic ovarian disease', 'infertile women with poly cystic ovarian disease (PCOS', '120 infertile women with PCOS referred to Ali-Ebne-Abitaleb hospital, Zahedan, Iran from February to August 2017 into two groups: group I received']","['dexamethasone', 'Letrozole plus Dexamethasone', 'letrozole alone and letrozole plus dexamethasone', 'letrozole', 'letrozole alone and group II recived letrozole plus dexamethasone', 'letrozole plus dexamethasone and letrozole alone']","['Pregnancy rate', 'mean diameter of follicles', 'pregnancy rate', 'endometrial thickness, follicle diameter, and ovulation', 'mean thickness of endometrium']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0029928', 'cui_str': 'Disorder of ovary'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}]",120.0,0.149039,Pregnancy rate was 8% in letrozole group and 23% in Letrozole plus Dexamethasone (p = 0.024).,"[{'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Farzaneh', 'Affiliation': 'Infectious Disease and Tropical Medicine Research Center, Zahedan University of Medical Science, Zahedan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Afshar', 'Affiliation': 'Zahedan University of Medical Science, Zahedan, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i4.6893']
1063,32497453,Outside-in or Inside-out? A Randomized Controlled Trial of Two Empowerment Approaches for Family Caregivers of People with Schizophrenia.,"Training-based intervention such as psychoeducational groups has become increasingly popular to empower family caregivers of people with schizophrenia, yet existing supportive programs for caregivers tend to focus more on the needs of the patients rather than the development of the caregivers. This study aimed to compare the outcomes of a skill-based empowerment psychoeducational group and an inner-resource enhancing empowerment narrative therapy group for family caregivers of people with schizophrenia. We conducted a randomized controlled trial with a longitudinal design. The sample consisted of 132 family caregivers who were randomly assigned to eight sessions of the two groups (i.e. a narrative-based group, or a psychoeducational group), or a control group with delayed treatment. Psychometric scales were administrated throughout the project. Both the psychoeducational group and the narrative group showed significant improvements in family relationships, caregiving burden, and coping skills compared with the control group across the three time points (pretest, posttest, and 2-month follow-up). A statistically significant advancement in coping skills was found in the psychoeducational group. The narrative group outperformed the psychoeducational group and the control group in the enhancement of inner resources, perceived control, and level of hope. The findings call for the need of an integrative empowerment approach that both values the inner strength and unique experiences of the caregivers and at the same time provides them with necessary skills and knowledge in taking care of their family members with schizophrenia.",2020,"The narrative group outperformed the psychoeducational group and the control group in the enhancement of inner resources, perceived control, and level of hope.","['Family Caregivers of People with Schizophrenia', 'family caregivers of people with schizophrenia', '132 family caregivers']","['control group with delayed treatment', 'skill-based empowerment psychoeducational group and an inner-resource enhancing empowerment narrative therapy']","['family relationships, caregiving burden, and coping skills', 'coping skills', 'Psychometric scales']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C3494322', 'cui_str': 'Narrative Therapy'}]","[{'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",132.0,0.0357367,"The narrative group outperformed the psychoeducational group and the control group in the enhancement of inner resources, perceived control, and level of hope.","[{'ForeName': 'De-Hui Ruth', 'Initials': 'DR', 'LastName': 'Zhou', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, North Point, Hong Kong.'}, {'ForeName': 'Yu-Lung Marcus', 'Initials': 'YM', 'LastName': 'Chiu', 'Affiliation': 'Department of Applied Social Science, City University of Hong Kong, Kowloon, Hong Kong.'}, {'ForeName': 'Tak-Lam William', 'Initials': 'TW', 'LastName': 'Lo', 'Affiliation': 'Mental Health, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Wai-Fan Alison', 'Initials': 'WA', 'LastName': 'Lo', 'Affiliation': 'Mental Health, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Siu-Sing', 'Initials': 'SS', 'LastName': 'Wong', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, North Point, Hong Kong.'}, {'ForeName': 'Kwok-Leung', 'Initials': 'KL', 'LastName': 'Luk', 'Affiliation': 'Department Operations Manager, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Chi-Hoi Tom', 'Initials': 'CT', 'LastName': 'Leung', 'Affiliation': 'East Kowloon Psychistric Center, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Chui-Kam', 'Initials': 'CK', 'LastName': 'Yu', 'Affiliation': 'East Kowloon Psychistric Center, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Yuk Sing Geoffrey', 'Initials': 'YSG', 'LastName': 'Chang', 'Affiliation': 'East Kowloon Psychistric Center, Kwai Chung Hospital, Kowloon, Hong Kong.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1734992']
1064,32502550,Linked-color imaging versus white-light colonoscopy in an organized colorectal cancer screening program.,"BACKGROUND AND AIMS


Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss rate as compared with standard white-light imaging (WLI) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) remains unclear.
METHODS


Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity were 1:1 randomized to undergo colonoscopy with LCI or WLI, both in high-definition systems. Insertion and withdrawal phases of each colonoscopy were carried out using the same assigned light. Experienced endoscopists from 7 Italian centers participated in the study. Randomization was stratified by gender, age, and screening round. The primary outcome measure was represented by ADR.
RESULTS


Of 704 eligible subjects, 649 were included (48.9% men, mean age ± standard deviation, 60.8 ± 7.3 years) and randomized to LCI (n = 326) or WLI (n = 323) colonoscopy. The ADR was higher in the LCI group (51.8%) than in the WLI group (43.7%) (relative risk, 1.19; 95% confidence interval, 1.01-1.40). The proportions of patients with advanced adenomas and sessile serrated lesions were, respectively, 21.2% and 8.6% in the LCI arm and 18.9% and 5.9% in the WLI arm (not significant for both comparisons). At multivariate analysis, LCI was independently associated with ADR, along with male gender, increasing age, and adequate (Boston Bowel Preparation Scale score ≥6) bowel preparation. At per-polyp analysis, the mean ± standard deviation number of adenomas per colonoscopy was comparable in the LCI and WLI arms, whereas the corresponding figures for proximal adenomas was significantly higher in the LCI group (.72 ± 1.2 vs .55 ± 1.07, P = .05) CONCLUSIONS: In FIT-positive patients undergoing screening colonoscopy, the routine use of LCI significantly increased the ADR. (Clinical trial registration number: NCT03690297.).",2020,"The ADR was higher in the LCI (51.8%) than in the WL group (43.7%) (RR, 1.19; 95% CI, 1.01-1.40).","['Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity', 'Experienced endoscopists from 7 Italian centers participated in the study', '704 eligible subjects, 649 (48.9% males, mean age +SD 60.8+7.3 years']","['WL', 'LCI', 'Linked-color imaging versus white-light colonoscopy', 'colonoscopy with LCI or WL, both in high-definition systems']","['mean+SD number of adenomas per colonoscopy', 'ADR', 'proximal adenomas', 'proportions of patients with advanced adenomas and sessile serrated lesions (SSL', 'adenoma detection rate (ADR']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",704.0,0.150298,"The ADR was higher in the LCI (51.8%) than in the WL group (43.7%) (RR, 1.19; 95% CI, 1.01-1.40).","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Paggi', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Senore', 'Affiliation': 'Department of Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maselli', 'Affiliation': 'Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy.'}, {'ForeName': 'Arnaldo', 'Initials': 'A', 'LastName': 'Amato', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Andrisani', 'Affiliation': 'Digestive Endoscopy Unit, Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Matteo', 'Affiliation': 'Digestive Endoscopy Unit, Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Cecinato', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Grillo', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Sereni', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Romano', 'Initials': 'R', 'LastName': 'Sassatelli', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Manfredi', 'Affiliation': 'Gastroenterology Department, ASST Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Alicante', 'Affiliation': 'Gastroenterology Department, ASST Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Buscarini', 'Affiliation': 'Gastroenterology Department, ASST Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Canova', 'Affiliation': 'Gastroenterology Unit, San Bortolo Hospital, Azienda ULSS n.8 Berica, Vicenza, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Milan', 'Affiliation': 'Gastroenterology Unit, San Bortolo Hospital, Azienda ULSS n.8 Berica, Vicenza, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pallini', 'Affiliation': 'Gastroenterology Unit, San Bortolo Hospital, Azienda ULSS n.8 Berica, Vicenza, Italy.'}, {'ForeName': 'Mineo', 'Initials': 'M', 'LastName': 'Iwatate', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rondonotti', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Department of Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.044']
1065,32502559,Optimal timing of a second postoperative voiding trial in women with incomplete bladder emptying after vaginal reconstructive surgery: a randomized trial.,"BACKGROUND


Rates of postoperative incomplete bladder emptying vary significantly after pelvic reconstructive surgery. With enhanced recovery protocols the paradigm is shifting towards same-day discharge and the rates of incomplete bladder emptying are expected to increase. The optimal length of time for postoperative catheter drainage has not been clearly established. There are no current studies that assess the optimal timing of a repeat voiding trial in women who have unsuccessful same day voiding trials.
OBJECTIVE


This study aimed to compare the outcomes of a second voiding trial performed 2-4 days (earlier group) vs 7 days (later group) postoperatively in women with incomplete bladder emptying after vaginal prolapse surgery. Secondary aims included postoperative urinary tract infection rates, total days with a catheter, and patient-reported catheter bother between groups.
STUDY DESIGN


Across 2 sites, women undergoing multicompartment vaginal repair were enrolled. Within 6 hours postoperatively, subjects had an active retrograde voiding trial. Those who passed this voiding trial exited the study; those who had persistent incomplete bladder emptying (postvoid residual >100 mL) had a transurethral indwelling catheter placed and were randomized to return for an earlier (postoperative day 2-4) vs later (postoperative day 7) follow-up office voiding trial. Subjects were followed for 6 weeks after surgery. The primary outcome was the rate of unsuccessful repeat office voiding trial. Secondary outcomes included rates of urinary tract infection, total days with a catheter, and subjective catheter bother. A power calculation based on a projected 31% difference, a power of 0.8, and an alpha of 0.05 revealed that 30 subjects were needed in each group.
RESULTS


A total of 102 subjects were enrolled; 38 exited on postoperative day 0, leaving 64 subjects for randomization (4 of whom withdrew after randomization). A comparison of data revealed that randomization was effective, with no differences between the earlier and later groups in terms of demographic data or surgical procedures. Using an intention-to-treat analysis, women in the earlier group were more likely to be unsuccessful in their follow-up office voiding trial (23.3%) than the later group (3.3%), with a risk difference of 20% (95% confidence interval, 3.56-36.44) and a relative risk of 7.00 (95% confidence interval, 0.92-53.47; P=.02). A number-needed-to-treat calculation found that for every 5 patients using a catheter for 7 days postoperatively, 1 case of persistent postoperative incomplete bladder emptying was prevented. Rates of catheter bother did not differ between groups at the time of the follow-up office voiding trial or at 6 weeks (P=.09 and P=.20, respectively). Urinary tract infection rates were higher in the earlier group but did not reach statistical significance (23% vs 7%, P=.07). Regression analysis revealed that subjects who required additional pain medication refills were 9.6 times (95% confidence interval, 1.24-73.77) more likely to have persistent incomplete bladder emptying after the follow-up office voiding trial.
CONCLUSION


Women with incomplete bladder emptying after multicompartment prolapse repair had a 7-fold higher risk of an unsuccessful repeat office voiding trial if performed within 4 days of surgery than when performed within 7 days of surgery. In addition, requiring additional prescriptions for analgesia increased the risk of an unsuccessful follow-up office voiding trial.",2020,A comparison of data revealed that randomization was effective with no differences between the earlier and later groups in terms of demographic data or surgical procedures.,"['women with incomplete bladder emptying following vaginal prolapse surgery', 'women with incomplete bladder emptying after vaginal reconstructive surgery', 'women undergoing multi-compartment vaginal repair were enrolled', 'Those who passed this VT exited the study; those who had persistent incomplete bladder emptying (postvoid residual >100ml) had a', '102 subjects were enrolled: 38 exited on post-operative day 0, leaving 64 subjects for randomization (4 of whom withdrew after randomization']",['transurethral indwelling catheter placed'],"['rates of urinary tract infection, total days with a catheter and subjective catheter bother', 'additional pain medication refills', 'incomplete bladder emptying', 'post-operative urinary tract infection (UTI) rates, total days with a catheter, and patient reported catheter bother between groups', 'rate of unsuccessful repeat office VT', 'Rates of catheter bother', 'UTI rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0344365', 'cui_str': 'Incomplete emptying of bladder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205990', 'cui_str': 'Vaginal wall prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1288276', 'cui_str': 'Vaginoplasty'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0344365', 'cui_str': 'Incomplete emptying of bladder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",102.0,0.290319,A comparison of data revealed that randomization was effective with no differences between the earlier and later groups in terms of demographic data or surgical procedures.,"[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Schachar', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ossin', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Department of Gynecology, Cleveland Clinic Florida, Weston, FL.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Plair', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hurtado', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Department of Gynecology, Cleveland Clinic Florida, Weston, FL.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Parker-Autry', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Badlani', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'G Willy', 'Initials': 'GW', 'LastName': 'Davila', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Department of Gynecology, Cleveland Clinic Florida, Weston, FL.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Matthews', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, the Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health, Winston-Salem, NC. Electronic address: CAMatthe@wakehealth.edu.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.001']
1066,32502564,What Is the Impact of Engaging With Natural Environments Delivered Via Virtual Reality on the Psycho-emotional Health of People With Spinal Cord Injury Receiving Rehabilitation in Hospital? Findings From a Pilot Randomized Controlled Trial.,"OBJECTIVES


This study investigated (1) the effect of engaging with 20-minute simulated natural environments delivered via virtual reality (VR) on current mood state and (2) the effect of engaging with multiple VR sessions over a period of a week on the depressive symptoms of people with a spinal cord injury (SCI).
DESIGN


Randomized controlled trial design.
SETTING


Spinal Cord Injury Rehabilitation Unit in Australia.
PARTICIPANTS


Participants (N=24) were assigned to a group engaging in VR sessions during week 1 (group 1, n=10) or week 2 (group 2, n=14).
INTERVENTIONS


The intervention week involved participation in up to three 20-minute VR sessions over 3 consecutive days. The control condition involved regular rehabilitation practice over a week.
MAIN OUTCOME MEASURES


The Patient Health Questionnaire-8 (PHQ-8) was completed prior to the first week (T1), after the first week and prior to the second week (T2), and after the second week (T3). Current feeling states, including depressed/happy, anxious/relaxed, and not feeling good/feeling good, were rated immediately prior and after each VR session.
RESULTS


Levels of happiness, relaxation, and feeling good were significantly higher subsequent to engaging with each VR session. Between-group differences in PHQ-8 scores were significantly greater for participants who experienced the intervention during the first week compared to participants within the control group: intervention participants had significant improvements in psycho-emotional health. Within-group PHQ-8 scores were reduced for each group subsequent to experiencing the intervention; however, differences were not significant.
CONCLUSIONS


Engaging with simulated natural environments delivered via VR can favorably affect the psycho-emotional health of people with SCI receiving rehabilitation in hospital. Future research including larger samples and investigating the effect over a longer time period is required to confirm the findings presented.",2020,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","['people with SCI receiving rehabilitation in hospital', 'Spinal Cord Injury Rehabilitation Unit in Australia', 'Participants (n=24', 'people with spinal cord injury receiving rehabilitation in hospital']","['engaging with 20 minute simulated natural environments delivered via virtual reality (VR', 'group engaging in VR sessions', 'natural environments delivered via virtual reality', 'engaging with multiple VR sessions']","['Levels of happiness, relaxation, and feeling good', 'psycho-emotional health', 'Patient Health Questionnaire-8 (PHQ-8', 'PHQ-8 scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0204101', 'cui_str': 'Spinal cord injury rehabilitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0262716,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Lakhani', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria; Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland. Electronic address: a.lakhani@latrobe.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland; Occupational Therapy Department, PA Hospital, Metro South Health Division of Rehabilitation, Woolloongabba, Queensland.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Occupational Therapy Department, PA Hospital, Metro South Health Division of Rehabilitation, Woolloongabba, Queensland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mallison', 'Affiliation': 'Western Sydney University, Penrith, New South Wales.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grimbeek', 'Affiliation': 'Upper Brookfield, Brisbane, Queensland.'}, {'ForeName': 'Izak', 'Initials': 'I', 'LastName': 'Hollins', 'Affiliation': 'Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland.'}, {'ForeName': 'Col', 'Initials': 'C', 'LastName': 'Mackareth', 'Affiliation': 'Spinal Life Australia, Woolloongabba, Queensland, Australia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.013']
1067,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder. This article is part of the special issue on Stress, Addiction and Plasticity.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177']
1068,32512291,"Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease.","There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II-mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. METHODS: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2-infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). SUMMARY: The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2-infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.",2020,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"['hospitalized SARS-CoV-2-infected patients', 'hospitAlized patieNts with SARS-COV-2 Infection Disease', 'severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients', 'adult hospitalized SARS-CoV-2-infected patients (n = 651']","['valsartan', 'ARB valsartan', 'angiotensin receptor blockers (ARBs', 'placebo arm will receive matching placebo', 'placebo']","['occurrence of ICU admission, mechanical ventilation, and death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.592181,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"[{'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Sara-Joan', 'Initials': 'SJ', 'LastName': 'Pinto-Sietsma', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Konst', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Mensink', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Cortenbach', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Dominique V M', 'Initials': 'DVM', 'LastName': 'Verhaert', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Maxim J P', 'Initials': 'MJP', 'LastName': 'Rooijakkers', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Anouke', 'Initials': 'A', 'LastName': 'van Rumund', 'Affiliation': 'Department of Neurology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Biostatistics, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Hassing', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Jan-Hein', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Experimental Cardiology, UMCG, Groningen, the Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk-Noordergraaf', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2020.05.010']
1069,32512353,A Randomized Controlled Trial of Transcultural Validation of Group-Based Psychosocial Intervention for Patients with Bipolar Disorder.,"Adjunctive psychosocial interventions are part of the preferred method to treat bipolar disorder (BD). This study aimed to conduct a randomized control and protocol-guided trial, in order to evaluate the feasibility and effectiveness of adjunctive group-based treatments for Chinese outpatients with BD. A single-blind trial in which 68 outpatients with BD were randomly assigned to either treatment as usual (TAU) or to an experimental group with 12 additional weekly sessions and 3 monthly booster sessions. Participants were assessed at baseline for mood condition, suicidal ideation, medication adherence, and quality of life (QoL), with follow-up assessments every 3 months over a 1-year period. The overall retention rate of this study was 89.7%. The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed. The results of this study support the transcultural validity and efficacy of group-based psychosocial intervention as anadjunct to TAU among Chinese outpatients with BD to promote improvements during the course of the illness including achieving euthymia, reducing depressive symptoms, and improving QoL.",2020,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","['68 outpatients with BD', 'Patients with Bipolar Disorder', 'Chinese outpatients with BD']","['Adjunctive psychosocial interventions', 'psychosocial intervention', 'Group-Based Psychosocial Intervention']","['mood condition, suicidal ideation, medication adherence, and quality of life (QoL', 'medication adherence, reduction in manic symptoms, or suicidal ideation', 'feasibility and effectiveness', 'depression symptoms', 'transcultural validity and efficacy', 'depressive symptoms, and improving QoL', 'overall retention rate']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",68.0,0.0479467,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","[{'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Health and Welfare Policy, National Yang-Ming University.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Yang', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Taiwan Adventist Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-I', 'Initials': 'SI', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Audiology and Speech Language Pathology, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hung', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'I-Chieh', 'Initials': 'IC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'School of Medicine, Deakin University, Victoria, Australia.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan. Electronic address: maryliuyip@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113139']
1070,32513299,"Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


Patients with severe COVID-19 often suffer from significant pulmonary fibrosis. Although the pathogenesis of pulmonary fibrosis has not been fully explained, the signal pathways and cytokines involved are very similar to hepatic fibrosis. This has been successfully treated with the Anluohuaxian Pill, a proprietary Chinese medicine composed of a variety of Chinese herbal medicines. The aim of this study is to evaluate the efficacy and safety of Anluohuaxian in the treatment of pulmonary fibrosis in patients with severe COVID-19.
TRIAL DESIGN


This is a prospective, multicenter, open, randomized controlled trial. The distribution ratio was 2:1, 500 cases in the experimental group and 250 cases in the control group.
PARTICIPANTS


Minimum Age: 18 Years Maximum Age: 80 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Inclusion Criteria: 1.Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);2.Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;3.High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);4.Voluntarily participate in research and sign informed consent.
EXCLUSION CRITERIA


1.Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;2.Have been diagnosed with connective tissue disease;3.Pregnant or lactating women;4.History of mental disorders, substance abuse or dependence;5.Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;6.Researchers consider it inappropriate to participate in research;7.Participating in other clinical research. This mutli-centre RCT will be undertaken in 9 trial centres: The Second People's Hospital of Fuyang, Ezhou Central Hospital, Huoshenshan Hospital of Wuhan, Jinyintan Hospital of Wuhan, Tongji Hospital of Huazhong University of Science and Technology, West Hospital Union Hospital Huazhong University of Science and Technology, Wuhan Pulmonary Hospital, Zhongnan Hospital of Wuhan University, Wenzhou Medical University Affiliated First Hospital.
INTERVENTION AND COMPARATOR


The research drug is Anluohuaxian Pill, which is provided by Senlong Pharmaceutical Co., Ltd. The basic therapeutic drugs for COVID-19 involved in the study include antiviral drugs. Brands can be selected according to the treatment routines of each research center to facilitate the improvement of treatment compliance.
MAIN OUTCOMES


Primary Outcome Measure: 1.Changes in high-resolution computer tomography of the lung Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography [Time Frame: 3 months] 2.Change in 6-minute walking distance [Time Frame: 3 months] RANDOMISATION: In this study, the central randomization system (IWRS, an interactive network response system based on network) is used to randomise the groups. The subjects who met the entry criteria were randomly divided into the experimental group and the control group according to the proportion of 2:1. In this study, the block randomized grouping method is used, and the block length is 6. The random grouping program is set up by statistical and computer professionals in the randomization process.
BLINDING (MASKING)


This is an open label trial. Trial participants, investigators, care givers, outcome assessors, and date analysts are not blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2 (Anluohuaxian combined with regular treatment group):1 (regular treatment group).
TRIAL STATUS


Protocol version number 3.0, 10th April 2020. The recruitment has not yet started. Actual Study Start Date: April 1, 2020 Estimated Primary Completion Date: June 1, 2020 Estimated Study Completion Date: December 1, 2020 TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04334265. Registered on 3 April 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,is negative twice after the treatment,"['subjects who met the entry criteria', 'patients with severe Coronavirus disease 2019- a multicenter', 'Patients with severe COVID-19 often suffer from significant pulmonary fibrosis', 'Registered on 3 April 2020', '1.Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;2.Have been diagnosed with connective tissue disease;3.Pregnant or lactating women;4.History of mental disorders, substance abuse or', 'Protocol version number 3.0, 10th April 2020', 'Minimum Age: 18 Years Maximum Age', ""9 trial centres: The Second People's Hospital of Fuyang, Ezhou Central Hospital, Huoshenshan Hospital of Wuhan, Jinyintan Hospital of Wuhan, Tongji Hospital of Huazhong University of Science and Technology, West Hospital Union Hospital Huazhong University of Science and Technology, Wuhan Pulmonary Hospital, Zhongnan Hospital of Wuhan University, Wenzhou Medical University Affiliated First Hospital"", '750 patients', 'Healthy Volunteers', '2020 Estimated Primary Completion Date: June 1, 2020 Estimated Study Completion Date: December 1, 2020 TRIAL REGISTRATION', 'patients with severe COVID-19', '80 Years Sex']","['Anluohuaxian', 'azathioprine, cyclophosphamide, interferon-γ', 'Anluohuaxian combined with regular treatment group):1 (regular treatment group', 'dependence;5.Have']","['distribution ratio', 'efficacy and safety', 'Efficacy and safety', '6-minute walking distance']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0859004,is negative twice after the treatment,"[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Chengli', 'Initials': 'C', 'LastName': 'Que', 'Affiliation': 'Department of Respiratory Disease, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. zhaohong_pufh@bjmu.edu.cn.'}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. john131212@126.com.'}]",Trials,['10.1186/s13063-020-04399-8']
1071,32520828,Autoimmune Hepatitis in Children: Prednisone Plus Azathioprine Versus Cyclosporine: A Randomized Trial.,"OBJECTIVE


The aim of this study was to find the outcome and adverse effects of 2 initial treatments in children with autoimmune hepatitis, prednisone (PRED) plus azathioprine (AZA) versus cyclosporine (CsA).
STUDY DESIGN


Between December 2008 and February 2012, 50 consecutive patients were centrally randomized to 1 of 2 treatment arms. Group 1: PRED was indicated at a dose of 1 to 2 mg · kg · day (up to 60 mg/day) and AZA at a dose of 1 to 2 mg · kg · day. Group 2: CsA was administered at a dose of 4 mg · kg · day orally divided into 2 doses. After remission, all patients were given a combination of PRED at 0.3 to 0.5 mg · kg · day and AZA at 1 to 2 mg · kg · day. Children presenting liver failure were placed on a triple immunosuppressive regimen if this condition persisted after 1 week of treatment, after liver function normalization they were switched back to their initial scheme.
RESULTS


A total of 26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 versus CsA: 13.6 weeks (P < 0.0081). All children recovered liver function in a mean time of 32 ± 26 days. Cushingoid syndrome was more frequently observed with PRED-AZA (P < 0.001) and gingival hypertrophy with CsA (P < 0.001). A significant increase in body mass index was observed in all patients from initial treatment to remission, being greater with PRED-AZA.
CONCLUSIONS


Similar outcomes were obtained with PRED plus AZA or CsA treatments. Either therapeutic strategy could be used according to the particular characteristics of each patient. Triple immunosuppression was beneficial in patients with liver failure at onset.",2020,"RESULTS


26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","['Children presenting liver failure (LF', '50 consecutive patients', 'Autoimmune Hepatitis in Children', 'patients with liver failure at onset', 'Between 12/2008-2/2012', 'children with autoimmune hepatitis (AIH']","['prednisone (PRED) plus azathioprine (AZA) vs cyclosporine (CsA', 'Cyclosporine', 'Triple immunosuppression', 'AZA', 'Prednisone Plus Azathioprine', 'CsA']","['Cushingoid syndrome', 'effectiveness and safety', 'PRED', 'gingival hypertrophy with CsA', 'liver function', 'body mass index (BMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0332601', 'cui_str': 'Cushingoid facies'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0017567', 'cui_str': 'Hypertrophy of gingiva'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.0972557,"RESULTS


26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","[{'ForeName': 'Miriam L', 'Initials': 'ML', 'LastName': 'Cuarterolo', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Ciocca', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'López', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Araujo', 'Affiliation': 'Nutrition Department, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Álvarez', 'Affiliation': 'Department of Pediatrics, CHU-Sainte Justine, University of Montreal, Montreal, Canada.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002776']
1072,32522495,"Re ""Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial"".",,2020,,['Vascular Surgery'],"['Re ""Gentamicin Containing Collagen Implants']",[],"[{'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0590992', 'cui_str': 'Collagen implant'}]",[],,0.162808,,"[{'ForeName': 'Barend M E', 'Initials': 'BME', 'LastName': 'Mees', 'Affiliation': 'Department of Vascular Surgery, Maastricht UMC+, Maastricht, the Netherlands. Electronic address: barend.mees@mumc.nl.'}, {'ForeName': 'Lina F', 'Initials': 'LF', 'LastName': 'Wübbeke', 'Affiliation': 'Department of Vascular Surgery, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Jan Willem H C', 'Initials': 'JWHC', 'LastName': 'Daemen', 'Affiliation': 'Department of Vascular Surgery, Maastricht UMC+, Maastricht, the Netherlands.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.04.023']
1073,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
1074,32540588,Deep transcranial magnetic stimulation for obsessive-compulsive disorder is efficacious even in patients who failed multiple medications and CBT.,"OCD is a chronic and disabling disease with a lifetime prevalence of 2%-3%. About 40-60% of these patients do not adequately respond to pharmacotherapy and CBT. Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals. Yet it is unclear whether patients who failed numerous medications and/or CBT can still benefit from dTMS. Here, we analyzed recent data from a double-blind multicenter dTMS study and found efficacy of this novel treatment even in OCD patient cohorts who previously failed to respond to multiple medications and CBT.",2020,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"['OCD patient cohorts who previously failed to respond to multiple medications and CBT', 'patients who failed multiple medications and CBT']","['OCD', 'Deep transcranial magnetic stimulation', 'Deep transcranial magnetic stimulation (dTMS']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0274375,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"[{'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Roth', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, TX, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Tendler', 'Affiliation': 'Advanced Mental Health Care, Inc., Palm Beach, FL, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2020.113179']
1075,32501613,The causal pathway effects of a physical activity intervention on adiposity in children: The KISS Study cluster randomized clinical trial.,"BACKGROUND


Very little information on the potential mechanisms of the physical activity interventions effects on adiposity is available. We evaluated the possible mediating factors of a physical activity school-based intervention on the sum of skinfolds in children.
METHODS


This is a cluster randomized trial, secondary analysis of the KISS study. Children (n = 499) from the first and fifth grades were randomly assigned to intervention or control group. Adiposity was estimated by four skinfolds, aerobic fitness assessed by the shuttle run test, and insulin, triglycerides, total cholesterol, high-density lipoprotein (HDL), and glucose collected via fasting blood samples.
RESULTS


The intervention affected aerobic fitness (0.140 SD, 95% CI 0.011 to 0.270), triglycerides (0.217 SD, 95% CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95% CI -0.334 to -0.047), glucose (-0.330 SD, 95% CI -0.538 to -0.121), and skinfolds (-0.122 SD, 95% CI -0.189 to -0.056). No intervention effect on insulin was found. We observed that changes in aerobic fitness impacted children's triglycerides and cholesterol/HDL ratio and consecutively the glucose levels mediating 30% of the intervention effect on skinfolds.
CONCLUSIONS


Our findings provided evidence of the positive metabolic distress caused by a physical activity intervention on adiposity levels in children.",2020,"The intervention affected aerobic fitness (0.140 SD, 95%CI 0.011 to 0.270), triglycerides (0.217 SD, 95%CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95%CI -0.334 to -0.047), glucose (-0.330 SD, 95%CI -0.538 to -0.121) and skinfolds (-0.122 SD, 95%CI -0.189 to -0.056).","['Children (n=499) from the first and fifth grades', 'children']","['physical activity intervention', 'physical activity school-based intervention']","['aerobic fitness', 'aerobic fitness assessed by the shuttle run test, and insulin, triglycerides, total cholesterol, high-density lipoprotein (HDL) and glucose collected via fasting blood samples', 'Adiposity', 'triglycerides', 'adiposity levels', ""aerobic fitness impacted children's triglycerides and cholesterol/HDL ratio"", 'cholesterol/HDL ratio']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.117116,"The intervention affected aerobic fitness (0.140 SD, 95%CI 0.011 to 0.270), triglycerides (0.217 SD, 95%CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95%CI -0.334 to -0.047), glucose (-0.330 SD, 95%CI -0.538 to -0.121) and skinfolds (-0.122 SD, 95%CI -0.189 to -0.056).","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sports Science, University of Graz, Graz, Austria.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Susi', 'Initials': 'S', 'LastName': 'Kriemler', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13741']
1076,32496736,Exercise Training Impacts Skeletal Muscle Clock in Adults with Prediabetes.,"PURPOSE


Disruption of the skeletal muscle molecular clock leads to metabolic disease, while exercise may be restorative, leading to improvements in metabolic health. The purpose of this study was to evaluate the effects of a 12-week exercise intervention on skeletal muscle molecular clock machinery in adults with obesity and prediabetes, and determine whether these changes were related to exercise-induced improvements in metabolic health.
METHODS


Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week exercise intervention and were fully provided isoenergetic diets. Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy) were assessed at baseline and after intervention. Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER 1/2 were measured by quantitative real-time PCR and Western blot, respectively.
RESULTS


Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max) all improved (P<0.005) with exercise training. Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged. The fold change in BMAL1 correlated with post GDR (r=0.43, P=0.044), BMI (r=-0.44, P=0.042), and body weight changes (r=-0.44, P=0.039) expressed as percent delta.
CONCLUSION


Exercise training impacts skeletal muscle molecular clock machinery in a clinically-relevant cohort of adults with obesity and prediabetes. Skeletal muscle BMAL1 gene expression may improve insulin sensitivity. Future studies are needed to determine the physiological significance of exercise-induced alterations in skeletal muscle clock machinery.",2020,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","['Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week', 'adults with obesity and prediabetes', 'Adults with Prediabetes']","['exercise intervention', 'Exercise training', 'Exercise Training', 'exercise intervention and were fully provided isoenergetic diets']","['Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy', 'Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max', 'Skeletal muscle BMAL1 gene', 'PER2 protein expression', 'BMAL1', 'BMI', 'while CLOCK, CRY1/2 and PER1', 'Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER', 'body weight changes']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0337076', 'cui_str': 'Industrial machine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",26.0,0.0285188,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002368']
1077,32503395,Effects of Collaborative Care for Comorbid Attention Deficit Hyperactivity Disorder Among Children With Behavior Problems in Pediatric Primary Care.,"This study evaluates the impact of a 6-month care management intervention for 206 children diagnosed with comorbid attention deficit hyperactivity disorder (ADHD) from a sample of 321 five- to 12-year-old children recruited for treatment of behavior problems in 8 pediatric primary care offices. Practices were cluster-randomized to Doctor Office Collaboration Care (DOCC) or Enhanced Usual Care (EUC). Chart reviews documented higher rates of service delivery, prescription of medication for ADHD, and titration in DOCC (vs EUC). Based on complex conditional models, DOCC showed greater acute improvement in individualized ADHD treatment goals and follow-up improvements in quality of life and ADHD and oppositional defiant disorder goals. Medication use had a significant effect on acute and follow-up ADHD symptom reduction and quality of life. Medication continuity was associated with some long-term gains. A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.",2020,A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.,"['Children', 'Comorbid Attention Deficit Hyperactivity Disorder', '206 children diagnosed with comorbid attention deficit hyperactivity disorder (ADHD) from a sample of 321 five- to 12-year-old children recruited for treatment of behavior problems in 8 pediatric primary care offices']","['Collaborative Care', 'care management intervention', 'Doctor Office Collaboration Care (DOCC) or Enhanced Usual Care (EUC']","['quality of life and ADHD and oppositional defiant disorder goals', 'acute and follow-up ADHD symptom reduction and quality of life', 'Medication continuity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031834', 'cui_str': ""Physician's Office""}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}]",206.0,0.0862828,A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Hart', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campo', 'Affiliation': 'Ohio State University, Morgantown, WV, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rounds', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Wolraich', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Clinical pediatrics,['10.1177/0009922820920013']
1078,32505019,"Indentation marks, skin temperature and comfort of two cervical collars: A single-blinded randomized controlled trial in healthy volunteers.","BACKGROUND


Collar-related pressure ulcers (CRPU) are a problem in trauma patients with a suspicion of cervical cord injury patients. Indentation marks (IM), skin temperature (T sk ) and comfort could play a role in the development of CRPU. Two comparable cervical collars are the Stifneck® and Philadelphia®. However, the differences between them remain unclear.
AIM


To determine and compare occurrence and severity of IM, T sk  and comfort of the Stifneck® and Philadelphia® in immobilized healthy adults.
METHODS


This single-blinded randomized controlled trial compared two groups of immobilized participants in supine position for 20 min.
RESULTS


All participants (n = 60) generated IM in at least one location in the observed area. Total occurrence was higher in the Stifneck®-group (n = 95 versus n = 69; p = .002). T sk  increased significantly with 1.0  °C in the Stifneck®-group and 1.3 °C in the Philadelphia®-group (p = .024). Comfort was rated 3 on a scale of 5 (p = .506).
CONCLUSION


The occurrence of IM in both groups was high. In comparison to the Stifneck®, fewer and less severe IM were observed from the Philadelphia®. The T sk  increased significantly with both collars; however, no clinical difference in increase of T sk  between them was found. The results emphasize the need for a better design of cervical collars regarding CRPU.",2020,Total occurrence was higher in the Stifneck®-group,"['immobilized healthy adults', 'trauma patients with a suspicion of cervical cord injury patients', 'healthy volunteers', 'participants in supine position for 20\xa0min']","['immobilized', 'Collar-related pressure ulcers (CRPU']","['Indentation marks (IM), skin temperature (T sk ) and comfort', 'T sk', 'severe IM', 'Total occurrence', 'Indentation marks, skin temperature and comfort of two cervical collars']","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0457846', 'cui_str': 'Segment of cervical spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}]",,0.152707,Total occurrence was higher in the Stifneck®-group,"[{'ForeName': 'J P L', 'Initials': 'JPL', 'LastName': 'Leenen', 'Affiliation': 'Department of Surgery, Isala, Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands. Electronic address: j.p.l.leenen@isala.nl.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Ham', 'Affiliation': 'Emergency Department, University Medical Center Utrecht, University of Applied Science, Institute of Nursing Studies, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: w.h.ham@umcutrecht.nl.'}, {'ForeName': 'L P H', 'Initials': 'LPH', 'LastName': 'Leenen', 'Affiliation': 'Department of Traumatology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: l.p.h.leenen@umcutrecht.nl.'}]",International emergency nursing,['10.1016/j.ienj.2020.100878']
1079,32686337,Raloxifene Prevents Early Periprosthetic Bone Loss for Postmenopausal Women after Uncemented Total Hip Arthroplasty: A Randomized Placebo-Controlled Clinical Trial.,"OBJECTIVE


To examine the results of raloxifene for prevention of periprosthetic bone loss around the femoral stem in patients undergoing total hip arthroplasty (THA).
METHODS


Between January 2015 and May 2017, 240 female patients between 55 and 80 years underwent primary THA and were randomly allocated to receive 60 mg raloxifene hydrochloride per day (treatment group, TG, n = 120) or placebo (control group, CG, n = 120) orally at bedtime using computer-generated randomization sequence generation. Baseline data, the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), women's quality of life (QoL) score, bone mineral density (BMD) around the prosthesis, and adverse events were compared between the two groups. The measuring range of BMD around the prosthesis was divided into seven regions of interest (ROI). The sample size was calculated to detect a mean difference in BMD of 0.15 g/cm 2  with a standard deviation (SD) of 0.3. The error was set at 0.05 and the power level at 90% with additional compensation for a possible dropout rate of 20%.
RESULTS


A total of 240 participants in the study up to 24 months after THA. There were no significant differences in the mean BMD of all the zones between groups before surgery (all P > 0.05). However, there were significant differences in the BMD of Gruen zones 4 and 7 between groups at 6 months postoperatively (both P < 0.05); there were significant differences in Gruen zones 1, 4, 6, and 7 at 12 months postoperatively (all P < 0.01); there were significant differences in Gruen zones 1, 2, 4, 6, and 7 at 24 months postoperatively (all P < 0.001). Patients taking raloxifene reported higher QoL scores, with better improvement in BMD in all areas except in zones 3 and 5 compared with the control group. There were no significant differences in WOMAC pain (P = 0.4045), WOMAC function (P = 0.4456) and women's QoL scores (P = 0.5983) between groups before surgery. However, WOMAC pain, WOMAC function and women's QoL score in the treatment group were significantly better at all time points (all P < 0.05). Patients in the treatment group showed no increased adverse events, including cardiac events, stroke, venous thromboembolism, and gynecological cancer (all P > 0.05), but did show decreased odds of breast cancer in comparison with those using a placebo (P = 0.0437).
CONCLUSION


Raloxifene can help inhibit bone loss around the prosthesis and improve the QoL of postmenopausal women after THA with no increased adverse events, and can even decrease the odds of breast cancer.",2020,"There were no significant differences in WOMAC pain (P = 0.4045), WOMAC function (P = 0.4456) and women's QoL scores (P = 0.5983) between groups before surgery.","['240 female patients between 55 and 80\u2009years underwent primary THA', 'Between January 2015 and May 2017', '240 participants in the study up to 24\u2009months after THA', 'Postmenopausal Women after Uncemented Total Hip Arthroplasty', 'patients undergoing total hip arthroplasty (THA']","['Placebo', 'placebo (control group, CG, n = 120) orally at bedtime using computer-generated randomization sequence generation', 'Raloxifene', 'raloxifene hydrochloride', 'raloxifene', 'placebo']","[""WOMAC pain, WOMAC function and women's QoL score"", 'bone loss', 'periprosthetic bone loss', 'Early Periprosthetic Bone Loss', ""Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), women's quality of life (QoL) score, bone mineral density (BMD) around the prosthesis, and adverse events"", 'BMD', 'odds of breast cancer', 'range of BMD', ""women's QoL scores"", 'QoL scores', 'WOMAC pain', 'adverse events, including cardiac events, stroke, venous thromboembolism, and gynecological cancer', 'adverse events', 'WOMAC function', 'BMD of Gruen zones', 'mean BMD']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0618111', 'cui_str': 'Raloxifene hydrochloride'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",240.0,0.0719752,"There were no significant differences in WOMAC pain (P = 0.4045), WOMAC function (P = 0.4456) and women's QoL scores (P = 0.5983) between groups before surgery.","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Department of Orthopaedic Surgery, China-Japan Friendship Hospital, Peking Union Medical College, Chinese Academy of Medical College, Beijing, China.'}, {'ForeName': 'Yao-Yao', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Bao Ding Maternal and Children Hospital, Baoding, China.'}, {'ForeName': 'Huan-Juan', 'Initials': 'HJ', 'LastName': 'Qian', 'Affiliation': 'Department of Orthopedics Surgery, 81 Group Military Hospital of Chinese PLA, Baoding, China.'}, {'ForeName': 'Ling-Kun', 'Initials': 'LK', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics Surgery, 81 Group Military Hospital of Chinese PLA, Baoding, China.'}, {'ForeName': 'Ming-Sheng', 'Initials': 'MS', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, China-Japan Friendship Hospital, Peking Union Medical College, Chinese Academy of Medical College, Beijing, China.'}]",Orthopaedic surgery,['10.1111/os.12696']
1080,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1081,32524309,Measurable residual disease after the first consolidation predicts the outcomes of patients with acute promyelocytic leukemia treated with all-trans retinoic acid and chemotherapy.,"We stratified patients with newly diagnosed acute promyelocytic leukemia (APL) according to a white blood cell (WBC) count of ≥ 3 × 10 9 /L (high risk) or < 3 × 10 9 /L (low risk) before administering risk-adapted chemotherapy in combination with all-trans retinoic acid (ATRA). In total, 27 low-risk and 23 high-risk patients were assigned to receive induction and three courses of consolidation with ATRA and anthracycline, followed by 2-year maintenance regimen. High-risk group additionally received cytarabine during 1st consolidation and another one-shot idarubicin treatment during 3rd consolidation. We prospectively monitored measurable residual disease (MRD) after induction and each consolidation. In the low-risk and high-risk groups, 5-year disease-free survival (DFS) rates were 86.5% and 81.2% (p = 0.862), and 5-year overall survival rates were 100% and 84.8% (p = 0.062), respectively. In the MRD-negative and MRD-positive groups, 5-year DFS rates were 91.7% and 78.4% (p = 0.402) and 84.7% and 60.0% (p = 0.102) after induction and 1st consolidation, respectively. Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively. Achieving MRD-negativity after 1st consolidation, rather than after induction, was a potential predictor of relapse and DFS in patients with APL treated with ATRA + chemotherapy.",2020,"Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively.","['stratified patients with newly diagnosed acute promyelocytic leukemia (APL) according to a white blood cell (WBC) count of\u2009≥\u20093\u2009×\u200910 9', 'patients with APL treated with ATRA\u2009+\u2009chemotherapy', 'In total, 27 low-risk and 23 high-risk patients', 'patients with acute promyelocytic leukemia']","['cytarabine', 'ATRA and anthracycline']","['5-year DFS rates', 'residual disease (MRD', '5-year disease-free survival (DFS) rates', '5-year overall survival rates', 'Achieving MRD-negativity', 'Relapse rates']","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",27.0,0.0290423,"Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively.","[{'ForeName': 'Hideho', 'Initials': 'H', 'LastName': 'Henzan', 'Affiliation': 'Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Kamimura', 'Affiliation': 'Department of Hematology, Harasanshin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Goichi', 'Initials': 'G', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nagafuji', 'Affiliation': 'Department of Hematology, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Ogawa', 'Affiliation': 'Department of Hematology, Japan Community Health Care Organization Kyushu Hospital, Kita-Kyushu, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Department of Hematology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Fujisaki', 'Affiliation': 'Department of Hematology, Matsuyama Red Cross Hospital, Ehime, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Minami', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yoshikane', 'Initials': 'Y', 'LastName': 'Kikushige', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Akashi', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. toshmiya@intmed1.med.kyushu-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of hematology,['10.1007/s12185-020-02911-z']
1082,32525761,A prospective quasi-experimental controlled study evaluating the use of dynamic elastomeric fabric orthoses to manage common postpartum ailments during postnatal care.,"OBJECTIVE


To evaluate the effectiveness of a postnatal dynamic elastomeric fabric orthoses to manage postpartum pain, improve functional capacity and enhance the quality of life arising from postnatal ailments immediately to an 8-week postpartum, compared with patients who did not wear dynamic elastomeric fabric orthoses.
METHOD


A total of 51 postpartum women were recruited (day 0 to 10 days post-delivery) from hospitals and community-based health clinics to participate in a prospective quasi-experimental controlled study using parallel groups without random allocation. The subgroup of the compression shorts group wore SRC recovery shorts and received standard postnatal care. The comparison group received standard postnatal care alone. Wear compliance was monitored throughout the study. Primary outcome measure, Numeric Pain Rating Scale, and secondary outcome measures, Roland Morris Disability Questionnaire, Pelvic Floor Impact Questionnaire-7, and Short Form (SF-36) were assessed fortnightly over 8 weeks for both groups.
RESULTS


The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)). However, there was insufficient evidence of a statistical difference in Numeric Pain Rating Scale score at 8 weeks when comparing the compression shorts group and comparison group (-1.17; 95%CI: (-2.35, -0.01),  R 2  = .19,  p  = .050). The compression shorts group met the wear compliance of the dynamic elastomeric fabric orthoses and reported an average wear of the dynamic elastomeric fabric orthoses as 9 out of 14 days for 11 h per day (SD 4.8 h) between the fortnightly timepoints.
CONCLUSION


The use of dynamic elastomeric fabric orthoses may be considered during postnatal care as a non-pharmacological therapeutic intervention to manage pain resulting from common postpartum ailments. While the dynamic elastomeric fabric orthoses was clinically well accepted by participants with high wearing compliance, future research with larger population samples are needed to enable statistical conclusions on the effectiveness of a dynamic elastomeric fabric orthoses in postnatal care to be made.
REGISTRATION


Trial registration was not required as per the Australian Government Department of Health, Therapeutic Goods Administration.",2020,"The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)).","['51 postpartum women were recruited (day 0 to 10 days post-delivery) from hospitals and community-based health clinics to participate in a prospective quasi-experimental controlled study using parallel groups without random allocation', 'patients who did not wear dynamic elastomeric fabric orthoses']","['95%CI', 'postnatal dynamic elastomeric fabric orthoses', 'dynamic elastomeric fabric orthoses', 'standard postnatal care alone']","['Numeric Pain Rating Scale, and secondary outcome measures, Roland Morris Disability Questionnaire, Pelvic Floor Impact Questionnaire-7, and Short Form (SF-36', 'Numeric Pain Rating Scale score', 'Wear compliance', 'mean (SD) Numeric Pain Rating Scale score']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}]","[{'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",51.0,0.0465939,"The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)).","[{'ForeName': 'Jaclyn Michele', 'Initials': 'JM', 'LastName': 'Szkwara', 'Affiliation': 'Physiotherapy Program, Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Milne', 'Affiliation': 'Physiotherapy Program, Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Rathbone', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}]","Women's health (London, England)",['10.1177/1745506520927196']
1083,32525946,Motion sickness symptoms during jumping exercise on a short-arm centrifuge.,"Artificial gravity elicited through short-arm human centrifugation combined with physical exercise, such as jumping, is promising in maintaining health and performance during space travel. However, motion sickness symptoms could limit the tolerability of the approach. Therefore, we determined the feasibility and tolerability, particularly occurrence of motion sickness symptoms, during reactive jumping exercises on a short-arm centrifuge. In 15 healthy men, we assessed motion sickness induced by jumping exercises during short-arm centrifugation at constant +1Gz or randomized variable +0.5, +0.75, +1, +1.25 and +1.5 Gz along the body axis referenced to center of mass. Jumping in the upright position served as control intervention. Test sessions were conducted on separate days in a randomized and cross-over fashion. All participants tolerated jumping exercises against terrestrial gravity and on the short-arm centrifuge during 1 Gz or variable Gz at the center of mass without disabling motion sickness symptoms. While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps. Our study demonstrates that repetitive jumping exercises are feasible and tolerable during short-arm centrifugation. Since jumping exercises maintain muscle and bone mass, our study enables further development of exercise countermeasures in artificial gravity.",2020,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.",['15 healthy men'],"['repetitive jumping exercises', 'Artificial gravity elicited through short-arm human centrifugation combined with physical exercise']","['feasibility and tolerability, particularly occurrence of motion sickness symptoms', 'motion sickness scores', 'Motion sickness symptoms']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0370295,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Frett', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'David Andrew', 'Initials': 'DA', 'LastName': 'Green', 'Affiliation': 'Space Medicine Team (HRE-OM), European Astronaut Centre, European Space Agency, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Arz', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Noppe', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Petrat', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kuemmel', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institutes of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0234361']
1084,32540235,Response Shift-Adjusted Treatment Effect on Health-Related Quality of Life in a Randomized Controlled Trial of Taxane Versus S-1 for Metastatic Breast Cancer: Structural Equation Modeling.,"OBJECTIVE


We investigated the quantification of the response shift-adjusted treatment effect on quality-of-life (QOL) data in a randomized controlled trial of taxane versus S-1 for patients with metastatic breast cancer (SELECT-BC).
METHODS


This study was a secondary data analysis of a previously published trial. The response shift-adjusted treatment effect on health-related QOL (HRQOL) data measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was estimated using structural equation modeling techniques in addition to quantifying the ""true"" treatment effect. Measurement invariances in the values of the common factor loadings, intercepts, and residual variances between before treatment and at the 3-, 6-, and 12-month visits were considered the response shift effects.
RESULTS


In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning. The observed change of -4.56 for role functioning comprised +2.26 response shifts and -6.82 ""true"" change. The observed change of +9.41 for emotional functioning comprised +12.43 response shifts and -1.17 ""true"" change. In the S-1 group, we observed positive reprioritization and negative recalibration effects for emotional functioning and positive reprioritization effects for social functioning. The observed change of +10.54 for emotional functioning comprised +10.07 response shifts and +0.47 ""true"" change. The observed change of +2.43 for social functioning comprised +3.50 response shifts and -1.07 ""true"" change.
CONCLUSION


Detailed analysis of the response shift effects will improve the evaluation reliability of observed HRQOL data during clinical trials.",2020,"In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning.","['Metastatic Breast Cancer', 'patients with metastatic breast cancer (SELECT-BC']","['taxane', 'taxane versus S-1', 'Taxane']","['health-related QOL (HRQOL) data', 'Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30', 'Health-Related Quality of Life', 'quality-of-life (QOL']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}]",,0.318176,"In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning.","[{'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Murata', 'Affiliation': 'Department of Oral Implantology, Osaka Dental University, Hirakata, Japan; CRECON Medical Assessment, Inc, Tokyo, Japan. Electronic address: tatsunori.murata@crecon.jp.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Suzukamo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Shiroiwa', 'Affiliation': 'Department of Health and Welfare Services, National Institute of Public Health, Saitama, Japan.'}, {'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Shimozuma', 'Affiliation': 'Department of Biomedical Sciences, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hirohumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Division of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.02.003']
1085,32543258,Randomized phase III trial comparing switch-maintenance pemetrexed with observation followed by pemetrexed at progression in advanced NSCLC.,"Objectives:  Two phase III trials show that maintenance pemetrexed therapy after platinum-doublet chemotherapy prolongs overall survival (OS) and progression free survival (PFS) in advanced non-squamous non-small-cell lung cancer (NSCLC). However, few patients in the control arms received pemetrexed at progression in these trials, performance status (PS) two patients were ineligible and few of the participants were elderly. Thus, we designed this study comparing immediate switch - maintenance pemetrexed therapy with pemetrexed at progression after platinum-doublet chemotherapy. Methods:  Patients with stage IIIB/IV non-squamous NSCLC, ≥18 years, PS 0-2, and non-progression after four courses of carboplatin/vinorelbine were randomized to receive immediate maintenance pemetrexed therapy or observation followed by pemetrexed at progression. The primary endpoint was OS, secondary endpoints were PFS, toxicity and health related quality of life (HRQoL). Results:  105 patients were randomized between May 2014 and September 2017. Median age was 67 years, 36% were >70 years, 9% had PS 2, 91% stage IV and 47% were women. In the observation arm, 73% received pemetrexed at progression. Patients in the maintenance arm had a numerically longer OS (median 12.0 vs. 10.0 months;  p  = .10) and a statistically significant longer PFS (median 3.1 vs. 1.9 months;  p  < .01). In multivariable analyses adjusting for baseline characteristics, there was a trend toward improved OS (HR 0.65, 95% CI 0.42-1.01);  p  = .05), and a significantly improved PFS (HR 0.53, 95% CI 0.35-0.80;  p  < .01). There were no significant differences in toxicity or HRQoL between the treatment arms. Conclusion:  There was a trend toward prolonged OS and significantly longer PFS from switch -  maintenance pemetrexed therapy when 73% of patients in the control arm received pemetrexed at progression.  ClinicalTrials.gov Identifier:  NCT02004184.",2020,Patients in the maintenance arm had a numerically longer OS (median 12.0 vs. 10.0 months;  p  = .10) and a statistically significant longer PFS (median 3.1 vs. 1.9 months;  p  < .01).,"['105 patients were randomized between May 2014 and September 2017', 'advanced non-squamous non-small-cell lung cancer (NSCLC', 'Patients with stage IIIB/IV non-squamous NSCLC', 'Median age was 67\u2009years, 36% were >70\u2009years, 9% had PS 2, 91% stage IV and 47% were women', 'advanced NSCLC']","['platinum-doublet chemotherapy', 'carboplatin/vinorelbine', 'pemetrexed']","['PFS', 'overall survival (OS) and progression free survival (PFS', 'numerically longer OS', 'PFS, toxicity and health related quality of life (HRQoL', 'toxicity or HRQoL']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",105.0,0.255321,Patients in the maintenance arm had a numerically longer OS (median 12.0 vs. 10.0 months;  p  = .10) and a statistically significant longer PFS (median 3.1 vs. 1.9 months;  p  < .01).,"[{'ForeName': 'Tarje O', 'Initials': 'TO', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Stokke', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Kristin T', 'Initials': 'KT', 'LastName': 'Killingberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Sunil X', 'Initials': 'SX', 'LastName': 'Raj', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Sørhaug', 'Affiliation': 'Department of Thoracic Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Odd Terje', 'Initials': 'OT', 'LastName': 'Brustugun', 'Affiliation': 'Department of Oncology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Fløtten', 'Affiliation': 'Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Helbekkmo', 'Affiliation': 'Department of Pulmonology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Hornslien', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Madebo', 'Affiliation': 'Department of Pulmonary Medicine, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Sverre', 'Initials': 'S', 'LastName': 'Fluge', 'Affiliation': 'Department of Pulmonary Medicine, Haugesund Hospital, Haugesund, Norway.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1778179']
1086,32682994,Time limited eating in adolescents with obesity (time LEAd): Study protocol.,"BACKGROUND


Time limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
OBJECTIVES


The aim of this study is to assess the feasibility of a TLE approach in adolescents with obesity using a continuous glucose monitor (CGM) to promote adherence to the intervention.
METHODS


We propose a prospective, randomized controlled trial, in 60 adolescents (ages 14-18) with obesity (BMI% ≥ 95th percentile). Youth will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy). Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline.
CONCLUSIONS


TLE is a potentially powerful lifestyle intervention that could be readily integrated into pediatric weight management programs to optimize their impact and accelerate healthy changes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03954223.",2020,"TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
","['60 adolescents (ages 14-18) with obesity (BMI%\u202f≥\u202f95th percentile', 'adolescents with obesity (time LEAd', 'adolescents with obesity using a', 'adults with obesity and type 2 diabetes (T2D']","['TLE approach', 'LSC\u202f+\u202fTLE', 'TLE', 'Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35\u202fg)/day; <90\u202fg carbohydrate (CHO)/day)\u202f+\u202fblinded CGM', 'continuous glucose monitor (CGM']","['total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.0740017,"TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
","[{'ForeName': 'Alaina P', 'Initials': 'AP', 'LastName': 'Vidmar', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America. Electronic address: avidmar@chla.usc.edu.""}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Goran', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Naguib', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Fink', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Choo Phei', 'Initials': 'CP', 'LastName': 'Wee', 'Affiliation': 'CTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hegedus', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Kelleen', 'Initials': 'K', 'LastName': 'Lopez', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106082']
1087,32682995,The impact of narratives and active video games on long-term moderate-to-vigorous physical activity: A randomized controlled trial protocol.,"BACKGROUND


Although physical activity (PA) has been shown in helping prevent and treat obesity, current PA interventions are still not effective in ameliorating the obesity epidemic. Additional forms of PA need to be investigated to improve PA engagement and outcomes. We hypothesize that pairing a narrative (i.e., story) with an active video game (AVG), a less traditional form of PA, will increase participant engagement in PA. This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes.
OBJECTIVE


This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes.
METHODS/DESIGN


The Active Video Game Study is a six-month randomized controlled single-blind trial projected to include 210 participants. The intervention strategy will pair a narrative to an active video game (AVG). Participants will be randomized into 3 groups: condition A [Narrative + AVG], condition B [AVG Only], and condition C [Control]. Participants will undergo three in-person data collection visits over the course of six months. Inclusion criteria are that children are between the ages of 8-12 and have a BMI ≥ 85%. The primary outcome is change in moderate to vigorous physical activity (MVPA). Secondary outcome measures include change in BMI percentile, fasting insulin and glucose, lipid panel, C-reactive protein, and cognitive function. A pilot trial of n = 6 was conducted to help develop procedures and address problems that could arise in the main trial.
DISCUSSION


Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.",2020,Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.,"['210 participants', 'long-term moderate-to-vigorous physical activity']","['physical activity (PA', 'narratives and active video games', 'condition A [Narrative + AVG], condition B [AVG Only], and condition C [Control']","['change in moderate to vigorous physical activity (MVPA', 'change in BMI percentile, fasting insulin and glucose, lipid panel, C-reactive protein, and cognitive function']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",210.0,0.130661,Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.,"[{'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Alon', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': 'Distinguished Emeritus Professor, Baylor College of Medicine, 1100 Bates St, Houston, TX 77030, United States.'}, {'ForeName': 'Tiago V', 'Initials': 'TV', 'LastName': 'Barreira', 'Affiliation': 'Exercise Science Department, Syracuse University, 820 Comstock Ave, Syracuse, NY 13244, United States.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Cabrera-Perez', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Chiu', 'Affiliation': 'Harvard Medical School, Primary Care Martha Eliot, 75 Bickford St, Jamaica Plain, MA 02478, United States.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fleischman', 'Affiliation': ""Harvard Medical School, Optimal Wellness for Life Clinic, Boston Children's Hospital, Boston, MA 02115, United States.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Floating Hospital for Children at Tufts Medical Center, Boston, MA 02111, United States.'}, {'ForeName': 'Jungyun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, Stanford University Medical Center, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Melanie C', 'Initials': 'MC', 'LastName': 'Green', 'Affiliation': 'Department of Communication, University at Buffalo, 359 Baldy Hall, Buffalo, NY 14260, United States.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02215, United States.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lessard', 'Affiliation': ""Research Division, Joslin Diabetes Center, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02215, United States.""}, {'ForeName': 'Lynne L', 'Initials': 'LL', 'LastName': 'Levitsky', 'Affiliation': 'Pediatric Endocrinology, Massachusetts General Hospital, Pediatrics, Harvard Medical School, 175 Cambridge St 5(th) Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Aika', 'Initials': 'A', 'LastName': 'Misawa', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Noubary', 'Affiliation': 'Department of Health Sciences, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Samuels', 'Affiliation': ""Children's Hospital Primary Care Center, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, United States.""}, {'ForeName': 'Kyung Jin', 'Initials': 'KJ', 'LastName': 'Sun', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, 1100 Bates Avenue, Houston, TX 77030, United States.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Lu', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States. Electronic address: a.lu@northeastern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106087']
1088,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
1089,32683384,Effect of lingual-based flap design on postoperative pain of impacted mandibular third molar surgery: Split-mouth randomized clinical trial.,"BACKGROUND


The extraction of third molars is one of the most common procedures in oral and maxillofacial surgery clinic. Surgical extraction involves the manipulation of both soft and hard tissues, so the patient usually experiences pain, swelling, and trismus in the immediate post-operative period. Several studies have been conducted using different types of surgical flaps to provide access with the least possible damage of soft tissues. Designing and implementing an optimum flap, which provides easier technique, better visibility, minimal post-operative complications, and best healing, is an aspired goal of every oral surgeon. This study aimed to compare lingual-based four-cornered flap with conventional triangular flap, and to evaluate its effect on post-operative pain after surgical extraction of impacted lower third molars.
MATERIAL AND METHODS


Seventeen patients (age ranged from 19 to 26 years) with bilateral, symmetrical impacted lower third molars (n=34) were included in the study. This was a randomized clinical trial with a split-mouth design. The impacted molars were assigned randomly, by coin flipping, to two groups: Case side with lingual-based four-cornered flap (Group A), and control side with conventional triangular flap (Group B). Away from the incision, the prognosis, surgical intervention, and postoperative procedures were exactly the same for the two groups. Postsurgical pain was assessed for 5 days using visual analogue scale (VAS) and by recording patients need for analgesics on a daily basis. Patients were also evaluated via a self-reporting questionnaire, i.e. Postoperative Symptoms Severity (PoSSe) scale, administered on the seventh postoperative day.
RESULTS


Pain scores recorded in Group A were found to be significantly lower as compared to pain scores in Group B in the 5 postoperative days (P<0.05). Total analgesic intake in Group B was significantly higher (P<0.05). PoSSe scores were lower in Group A, however, this difference was insignificant (P>0.05).
CONCLUSIONS


According to the data of the current study and within its limits, it appeared that lingual-based four-cornered flap design was superior to the conventional triangular flap regarding the postsurgical discomfort and pain.",2020,Total analgesic intake in Group B was significantly higher (P<0.05).,"['Seventeen patients (age ranged from 19 to 26 years) with bilateral, symmetrical impacted lower third molars (n=34) were included in the study', 'postoperative pain of impacted mandibular third molar surgery']","['Case side with lingual-based four-cornered flap (Group A), and control side with conventional triangular flap', 'lingual-based flap design', 'lingual-based four-cornered flap with conventional triangular flap']","['pain scores', 'Total analgesic intake', 'PoSSe scores', 'visual analogue scale (VAS', 'Postsurgical pain', 'self-reporting questionnaire, i.e. Postoperative Symptoms Severity (PoSSe) scale', 'Pain scores']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",34.0,0.119895,Total analgesic intake in Group B was significantly higher (P<0.05).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hassan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery Faculty of Dentistry, Syrian Private University P.O. Box 36822, Damascus, Syria nuraldeen.alkhanati@gmail.com.'}, {'ForeName': 'N-M', 'Initials': 'NM', 'LastName': 'Al-Khanati', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bahhah', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23666']
1090,32683388,Hemostatic agents in endodontic surgery of maxillary molars: A randomized controlled pilot study of polytetrafluoroethylene (PTFE) strips as an adjunct to epinephrine impregnated gauze versus aluminum chloride.,"BACKGROUND


Hemostasis is of critical importance in endodontic surgery. Studies on bleeding control in maxillary molars are scarce. The present study compares the efficacy of two hemostatic techniques in controlling bleeding in endodontic surgery.
MATERIAL AND METHODS


A randomized two-arm pilot study involving 30 patients with peri-radicular lesions in maxillary molars (first and second molars) was carried out including the following hemostatic agents: polytetrafluoroethylene (PTFE) strips as an adjunct to epinephrine impregnated gauze (test group; n = 15) and aluminum chloride (Expasyl™) (control; n = 15). Bleeding control was independently assessed by the surgeon and by two blinded observers before and after application of the hemostatic agent, and was classified as either adequate (complete bleeding control) or inadequate (incomplete bleeding control).
RESULTS


Bleeding control was similar in both groups. Simple binary logistic regression analysis failed to identify variables affecting bleeding control. Only the height of the keratinized mucosal band (≥ 2 mm) suggested a decreased risk of inadequate bleeding control of up to 89% (OR=0.11; p=0.06).
CONCLUSIONS


No difference in the efficacy of bleeding control was observed between PTFE strips as an adjunct to epinephrine impregnated gauze and aluminum chloride in maxillary molars.",2020,No difference in the efficacy of bleeding control was observed between PTFE strips as an adjunct to epinephrine impregnated gauze and aluminum chloride in maxillary molars.,"['30 patients with peri-radicular lesions in maxillary molars (first and second molars', 'endodontic surgery of maxillary molars']","['epinephrine impregnated gauze (test group; n = 15) and aluminum chloride (Expasyl™', 'polytetrafluoroethylene (PTFE) strips', 'epinephrine impregnated gauze and aluminum chloride', 'Hemostatic agents', 'hemostatic agents: polytetrafluoroethylene (PTFE) strips', 'hemostatic techniques', 'epinephrine impregnated gauze versus aluminum chloride']","['Bleeding control', 'efficacy of bleeding control', 'risk of inadequate bleeding control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019120', 'cui_str': 'Hemostatic agent'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0019119', 'cui_str': 'Hemostatic Technics'}]","[{'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",30.0,0.0325652,No difference in the efficacy of bleeding control was observed between PTFE strips as an adjunct to epinephrine impregnated gauze and aluminum chloride in maxillary molars.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Peñarrocha-Oltra', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Soto-Peñaloza', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cervera-Ballester', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cabanes-Gumbau', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23652']
1091,32561410,Computer-aided detection-assisted colonoscopy: classification and relevance of false positives.,"BACKGROUND AND AIMS


False positive (FP) results by computer-aided detection (CADe) hamper the efficiency of colonoscopy by extending examination time. Our aim was to develop a classification of the causes and clinical relevance of CADe FPs, and to assess the relative distribution of FPs in a real-life setting.
METHODS


In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe colonoscopy videos. Using a modified Delphi process, 4 expert endoscopists identified the main domains for the reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP and classified it according to the proposed domains. The analysis was limited to the withdrawal phase.
RESULTS


The 2 main domains for the causes of CADe FPs were identified as artifacts due to either the mucosal wall or bowel content, and clinical relevance was defined as the time spent on FPs and the FP rate per minute. The mean number of FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) were due to artifacts in the bowel wall and bowel content, respectively. Of the 27.3 FPs per colonoscopy, 1.6 (5.7%) required additional exploration time of 4.8 ± 6.2 seconds per FP (ie, 0.7% of the mean withdrawal time). In detail, 15 (24.2%), 33 (53.2%), and 14 (22.6%) FPs were classified as being of mild, moderate, or severe clinical relevance. The rate of FPs per minute of withdrawal time was 2.4 ± 1.2, and was higher for FPs due to artifacts from the bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, P < .001).
CONCLUSIONS


FPs by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase in the total withdrawal time because most of them are immediately discarded by the endoscopist.",2020,"Of the 27.3 FP per colonoscopy, 1.6 (5.7%) required an additional exploration time of 4.8 ± 6.2 seconds per FP, ie, 0.7% of the mean withdrawal time (WT).",[],"['colonoscopy with and without CADe (NCT', 'Computer-aided detection-assisted colonoscopy']","['mean withdrawal time (WT', 'Mean FPs per colonoscopy', 'Rate of FP per minute of WT', 'total withdrawal time', 'causes of CADe-FPs']",[],"[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.0532188,"Of the 27.3 FP per colonoscopy, 1.6 (5.7%) required an additional exploration time of 4.8 ± 6.2 seconds per FP, ie, 0.7% of the mean withdrawal time (WT).","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Badalamenti', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maselli', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Correale', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Iannone', 'Affiliation': 'Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of ""Aldo Moro"" of Bari, Bari.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rondonotti', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spadaccini', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Thanyan Alghanim Center for Gastroenterology and Hepatology, Alamiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fugazza', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderloni', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Piera Alessia', 'Initials': 'PA', 'LastName': 'Galtieri', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Pellegatta', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Carrara', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Di Leo', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Craviotto', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lamonaca', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorenzetti', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Andrealli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Kansas City Veterans Affairs Hospital, Kansas City, Kansas, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosch', 'Affiliation': 'Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.021']
1092,32561426,Recombinant human thrombopoietin in critically ill patients with sepsis-associated thrombocytopenia: A clinical study.,"BACKGROUND


Sepsis causes varying degrees of thrombocytopenia that are closely related to the likelihood of patient mortality. This study analysed the effect of recombinant human thrombopoietin (rhTPO) on the platelet count in critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment.
MATERIAL/METHODS


The study was a retrospective analysis of the clinical data of patients. Patients were divided into an rhTPO group and control group according to rhTPO use during treatment. Demographical and clinical data (age, sex, history of hypertension, diabetes, platelet counts, mortality rate, etc.) of the patients were collected and analysed using statistical software; p < 0.05 was considered statistically significant.
RESULTS


Of 213 patients, 84 constituted the rhTPO group and 129 constituted the control group. The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01 ± 18.23 × 10 9 /L vs. 36.31 ± 14.17 × 10 9 /L, p = 0.003), fifth day (71.51 ± 39.59 × 10 9 /L vs. 42.95 ± 20.48 × 10 9 /L, p < 0.001) and seventh day (115.36 ± 69.41 × 10 9 /L vs. 62.54 ± 42.70 × 10 9 /L, p < 0.001). Further statistical analysis of the data of patients with platelet counts ≤30 × 10 9 /L and >30 × 10 9 /L and APACHE II scores >15 and ≤15 at the time of diagnosis showed that the increase in platelet counts in the rhTPO group was greater. There was no significant between-group difference in volume of platelet transfusions (rhTPO group 15.42 ± 17.20 vs. control group 10.93 ± 17.48, p = 0.068). The cost of ICU treatment in patients with rhTPO was higher (RMB 126,936.21 ± 86,548.27 vs. 101,685.28 ± 77,291.75, p = 0.027); however, the ICU stay time was shorter (9.20 ± 5.38 vs. 10.88 ± 6.82, p = 0.047). There was no significant difference in 28-day mortality (rhTPO group: 25.0% vs. control group: 34.1%, p = 0.158) between the two groups.
CONCLUSION


For patients with severe thrombocytopenia or severe sepsis, rhTPO was efficacious in increasing their platelet counts, resulting in a shorter ICU stay time.",2020,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"['patients with severe thrombocytopenia or patients with severe sepsis', 'patients with platelet counts', 'critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment', '213 patients', '84 patients constituted the rhTPO group and 129 constituted the control group', 'critically ill patients with sepsis-associated thrombocytopenia', '≤30×10 9']","['recombinant human thrombopoietin (rhTPO', 'Recombinant human thrombopoietin', 'rhTPO']","['ICU stay time', 'platelet counts', 'volume of platelet transfusions', 'cost of ICU treatment', '28-days mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",213.0,0.0258731,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': ""Emergency Department, Xi'an Aerospace General Hospital, Xi'an, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: wangxuejd2008@126.com.""}, {'ForeName': 'Litao', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: glt2002@xjtu.edu.cn.""}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.045']
1093,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069']
1094,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS


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


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


ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070']
1095,32562807,Minimising COVID-19 exposure during tracheal intubation by using a transparent plastic box: A randomised prospective simulation study.,,2020,,[],[],[],[],[],[],,0.0231458,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clariot', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France. Electronic address: simon.clariot@aphp.fr.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Dumain', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gauci', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Langeron', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France; Experimental Neuropathology Unit, Institut Pasteur, 75015 Paris, France.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Levesque', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France; EA DYNAMYC Université Paris-Est Créteil (UPEC), École Nationale Vétérinaire d'Alfort (ENVA), Faculté de Santé de Créteil, 8, rue du Général Sarrail, 94010 Créteil, France.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.06.005']
1096,32563378,"Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.","BACKGROUND


Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding.
METHODS


We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.
FINDINGS


Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).
INTERPRETATION


We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"['patients with gastrointestinal bleeding', 'Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding', 'patients with trauma', '164 hospitals in 15 countries', 'patients with acute gastrointestinal bleeding (HALT-IT', 'Between July 4, 2013, and June 21, 2019, we randomly allocated 12\u2008009 patients to receive']","['Tranexamic acid', 'placebo', 'matching placebo', 'tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9', 'tranexamic acid', '0·9% sodium chloride']","['death due to bleeding', 'death and thromboembolic events', 'Venous thromboembolic events (deep vein thrombosis or pulmonary embolism', 'Arterial thromboembolic events (myocardial infarction or stroke', 'Death due to bleeding', 'death from gastrointestinal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0024050', 'cui_str': 'Lower gastrointestinal hemorrhage'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0266807', 'cui_str': 'Acute gastrointestinal hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0104485', 'cui_str': 'AT 125'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",12009.0,0.734066,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30848-5']
1097,32565122,A Secondary Analysis from a Randomized Trial on the Effect of Plasma Tetrahydrocannabinol Levels on Pain Reduction in Painful Diabetic Peripheral Neuropathy.,"This report examines the association between tetrahydrocannabinol (THC) plasma levels and pain response in a secondary analysis of data from a recent diabetic neuropathy study that demonstrated a dose-dependent reduction in spontaneous and elicited pain at specific time points. A randomized, double-blinded, placebo-controlled crossover study was conducted in sixteen patients with painful diabetic peripheral neuropathy. Subjects participated in four sessions, separated by 2 weeks, during each of which they were exposed to one of four conditions: placebo, or 1%, 4%, or 7% THC dose of cannabis. Baseline assessments of spontaneous and evoked pain were performed. Subjects were then administered aerosolized cannabis or placebo and pain intensity and cognitive testing at specific time points for 4 hours. A blood sample was drawn from the left antecubital vein for plasma assay of total THC at 0, 15, 30, 45, 60, 150, and 240 minutes. Associations were made between pain intensity, cognitive impairment and THC plasma levels in this secondary analysis. Results suggested a U-shaped relation whereby pain ratings are greatest at extreme (low and high) levels of THC. The therapeutic window appeared to fall between 16 ng/mL and 31 ng/mL THC plasma level. There was a significant linear effect of THC on only one out of the three cognitive tests. These findings stress the importance of measuring cannabinoid plasma levels when performing future research. Perspective: This analysis correlating plasma THC levels and pain reduction in diabetic neuropathy suggest a therapeutic window. Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). There was a minor negative linear effect of THC on cognitive function.",2020,Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). ,"['sixteen patients with painful diabetic peripheral neuropathy (PDN', 'Painful Diabetic Peripheral Neuropathy']","['THC', 'Plasma Tetrahydrocannabinol Levels', 'aerosolized cannabis or placebo', 'placebo']","['THC levels', 'Pain Reduction', 'cognitive function', 'pain intensity, cognitive impairment and THC plasma levels', 'THC plasma level', 'pain ratings', 'spontaneous and evoked pain', 'THC plasma levels and pain response']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",16.0,0.176395,Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). ,"[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Wallace', 'Affiliation': 'Department of Anesthesiology, School of Medicine, University of California, San Diego, La Jolla, CA. Electronic address: mswallace@ucsd.edu.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Marcotte', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA; Department of Psychiatry, VA San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Hayley Treloar', 'Initials': 'HT', 'LastName': 'Padovano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Center for Alcohol and Addiction Studies, Brown University, Providence, RI.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bonn-Miller', 'Affiliation': 'Director, Cannabinoid Research, Zynerba Pharmaceuticals, Devon, PA.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.03.003']
1098,32565127,Comparison of Overall Survival Between De Novo and Secondary Acute Lymphoblastic Leukemia Patients of Different Ages.,"PURPOSE


To compare the overall survival (OS) between de novo and secondary acute lymphoblastic leukemia (ALL) patients in different age groups after chemotherapy.
PATIENTS AND METHODS


Data from 8305 ALL patients undergoing chemotherapy from the Surveillance, Epidemiology, and End Results (SEER) database during 1975 to 2015 were included in this study, of which 7454 (80.11%) were in the de novo ALL group, and 851 (19.89%) were in the secondary ALL (sALL) group. Propensity matching was used before comparison of OS between the two groups.
RESULTS


Female ALL patients had a lower risk of death than male (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.88-0.98; P < .01). The mortality of black patients was higher than in white patients (HR, 1.29; 95% CI, 1.18-1.42; P < .001). Patients aged 45-75 years (HR, 1.82; 95% CI, 1.72-1.94; P < .001) and ≥ 75 years (HR, 3.85; 95% CI, 3.52-4.23; P < .001) had a higher risk of death. Separated/divorced (HR, 1.21; 95% CI, 1.10-1.34; P < .001) and widowed (HR, 1.35; 95% CI, 1.21-1.51; P < .001) patients had a higher risk of death than single patients. sALL patients had a higher risk of death than de novo ALL patients (HR, 1.21; 95% CI, 1.12-1.30; P < .001). The mean age of the de novo ALL group was lower than in the sALL group (51.05 vs. 60.25; P < .001) after the propensity score was matched, and the 1-, 2-, 3-, 4-, and 5-year OS of the de novo ALL group were higher than that of the sALL group aged 18-75 years (P < .001).
CONCLUSION


The survival rate of ALL decreased with increased age. Patients with sALL had poorer OS than de novo patients aged 18-75 years.",2020,"ALL group were higher than that of the sALL group aged 18-75 years (P < .001).
","['de novo and secondary acute lymphoblastic leukemia (ALL) patients in different age groups after chemotherapy', 'Data from 8305 ALL patients undergoing chemotherapy from the Surveillance, Epidemiology, and End Results (SEER) database during 1975 to 2015 were included in this study, of which 7454 (80.11%) were in the de novo ALL group, and 851 (19.89%) were in the secondary ALL (sALL) group', 'Acute Lymphoblastic Leukemia Patients of Different Ages']",['sALL'],"['risk of death', 'mortality of black patients', '5-year OS of the de novo', 'Overall Survival', 'poorer OS', 'overall survival (OS', 'survival rate of ALL']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]",,0.200058,"ALL group were higher than that of the sALL group aged 18-75 years (P < .001).
","[{'ForeName': 'Jiansheng', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Hematology, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China. Electronic address: jianshengz123@163.com.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Laboratory, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.04.013']
1099,32572777,Protective Effects of Salvianolate on Myocardial Injury or Myocardial Infarction after Elective Percutaneous Coronary Intervention in NSTE-ACS Patients: A Randomized Placebo-Controlled Trial.,"OBJECTIVE


To evaluate the protective effects of salvianolate on percutaneous coronary intervention (PCI) related myocardial injury or myocardial infarction after elective PCI in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients.
METHODS


A total of 149 patients with NSTE-ACS who underwent elective PCI were enrolled. The patients were randomly allocated in a 1:1 ratio to the salvianolate group (74 cases) or the control group (75 cases). After exclusion criteria of coronary angiography, 60 patients with PCI therapy remained in the salvianolate group and 68 in the control group. The incidence and the severity of PCI related myocardial injury or myocardial infarction, in addition to major adverse cardiac events (MACEs) during 1 year follow-up after PCI were studied between the two groups. Multivariate logistic regression analysis was used to determine the independent factors for PCI related myocardial injury or myocardial infarction after elective PCI.
RESULTS


Compared with the control group, salvianolate treatment reduced the incidence of PCI related severe myocardial injury or myocardial infarction (11.7% vs. 26.5%, P=0.035). The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups.
CONCLUSIONS


Periprocedural treatment with salvianolate reduces the incidence of PCI related severe myocardial injury or myocardial infarction, although it does not influence clinical prognosis. [Chinese clinical trial registry: ChiCTR1800016992].",2020,"The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups.
","['non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients', '149 patients with NSTE-ACS who underwent elective PCI were enrolled', 'Myocardial Injury or Myocardial Infarction after Elective Percutaneous Coronary Intervention in NSTE-ACS Patients', '60 patients with PCI therapy remained in the salvianolate group and 68 in the control group']","['percutaneous coronary intervention (PCI', 'Salvianolate', 'salvianolate', 'Placebo']","['severity of PCI related myocardial injury or myocardial infarction, in addition to major adverse cardiac events (MACEs', 'incidence of PCI related severe myocardial injury or myocardial infarction', 'rate of MACEs or all-cause death']","[{'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3252125', 'cui_str': 'salvianolate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C3252125', 'cui_str': 'salvianolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",149.0,0.0886597,"The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups.
","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ou', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Sheng-Jia', 'Initials': 'SJ', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Hai-Ming', 'Initials': 'HM', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Luo', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Xin-Ping', 'Initials': 'XP', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Yun-Zhi', 'Initials': 'YZ', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Yu-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Hong-Ying', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Medical Department, Shanghai Green Valley Pharmaceutical Co., Ltd., Shanghai, 201203, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China. drshenwei@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-2728-0']
1100,32573767,Information on early medical abortion for women using an audiovisual animation versus face-to-face consultation: A consortium randomized and quasi-randomized trial.,"INTRODUCTION


There is some evidence that audiovisual formats can be an effective way of providing information about early medical abortion (EMA). A short animation (3 minutes) was developed about EMA in three languages that summarized the EMA process for use in the UK, France and Sweden.
MATERIAL AND METHODS


We conducted a multicenter randomized controlled trial to compare information on EMA delivered by an animated film versus a face-to-face consultation. Women requesting EMA (≤9 weeks' gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited. The primary outcome was women's recall of prespecified key information on EMA. Secondary outcomes were acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale. The study was prospectively registered with clinicaltrials.gov, ID number: NCT03417362.
RESULTS


172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48). There was no statistically significant difference in recall scores between the animation and standard arms in Edinburgh and Stockholm sites. However, the difference between arms at the Paris site was statistically significant (P = .007) in favor of the animation. All participants in the animation arm rated it as an acceptable way to receive information on EMA.
CONCLUSIONS


A ""short"" audiovisual animation can adequately and acceptably deliver key information about EMA. This intervention could be used routinely to provide standardized and high-quality information to women seeking EMA.",2020,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","['Women requesting EMA (<=9 weeks gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited', '172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48']",['audiovisual animation'],"['recall scores', ""women's recall of prespecified key information on EMA"", 'acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000789', 'cui_str': 'Abortion Clinics'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376650', 'cui_str': 'Animation'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",172.0,0.142109,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Reynolds-Wright', 'Affiliation': 'MRC Centre for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Belleuvre', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Daberius', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Faucher', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'MRC Centre for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13944']
1101,32568808,A Randomized Controlled Trial of a Physical Activity Intervention for Self-management of Fatigue in Adolescents and Young Adults With Cancer.,"BACKGROUND


Fatigue remains a persistent and troubling symptom for adolescents and young adults (AYAs) with cancer. Physical activity (PA) is recommended as a strategy for self-management of fatigue.
OBJECTIVE


The aim of the study was to examine a PA intervention to improve the self-management of fatigue in AYAs during chemotherapy.
METHODS


This randomized controlled trial enrolled AYAs (18-39 years) receiving chemotherapy. Adolescents and young adults in the intervention group received a 12-week PA intervention integrated into 5 clinic visits that included education, PA tracking, and collaboration. Physical activity was measured with an accelerometer, and participants completed measures of fatigue severity, self-efficacy for PA, and self-regulation at baseline and end of study.
RESULTS


Forty-four AYAs completed the study. At baseline, AYAs averaged 4290 (SD, 2423) steps/day and 14.4 (SD, 20.6) minutes/day of moderate- to vigorous-intensity PA; their average Patient-Reported Outcomes Measurement Information System fatigue score was 55.0 (SD, 9.2). At end of study, there were no significant differences between groups in fatigue, self-efficacy, self-regulation, or PA, but trends in the desired direction were observed for each of the variables in the intervention group.
CONCLUSION


During chemotherapy, AYAs had variable levels of PA and engaged in mostly light-intensity PA. Their average fatigue level was slightly worse than a national comparison group.
IMPLICATIONS FOR PRACTICE


Tailored interventions are needed to promote PA in AYAs as a self-management strategy for fatigue. Enhancing self-efficacy and self-regulation may be important approaches to promote PA.",2020,"At end of study, there were no significant differences between groups in fatigue, self-efficacy, self-regulation, or PA, but trends in the desired direction were observed for each of the variables in the intervention group.
","['Adolescents and Young Adults With Cancer', 'Forty-four AYAs completed the study', 'adolescents and young adults (AYAs) with cancer', 'Adolescents and young adults']","['PA intervention', 'PA intervention integrated into 5 clinic visits that included education, PA tracking, and collaboration', 'Physical Activity Intervention', 'Physical activity (PA', 'chemotherapy']","['fatigue, self-efficacy, self-regulation, or PA', 'Physical activity', 'Outcomes Measurement Information System fatigue score', 'average fatigue level', 'fatigue severity, self-efficacy for PA, and self-regulation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0738748,"At end of study, there were no significant differences between groups in fatigue, self-efficacy, self-regulation, or PA, but trends in the desired direction were observed for each of the variables in the intervention group.
","[{'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Erickson', 'Affiliation': 'Author Affiliations: College of Nursing (Drs Erickson and Ke) and College of Health Sciences and Department of Kinesiology (Mr Tokarek and Dr Swartz), University of Wisconsin-Milwaukee, Milwaukee, Wisconsin.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Tokarek', 'Affiliation': ''}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Ke', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Swartz', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000834']
1102,32570152,To study the changes in maternal hemodynamics with intravenous labetalol or nifedipine in acute severe hypertension.,"OBJECTIVE


To study the maternal hemodynamic changes in acute severe hypertension after treatment with intravenous labetalol or oral nifedipine using color doppler ultrasound.
STUDY DESIGN


We evaluated thirty pregnant women with gestational age between 28 and 40 weeks in acute severe hypertension (more than or equal to 160/105 mmHg) which were randomly allocated to receive either intravenous labetalol or oral nifedipine until blood pressure was lowered to less than or equal to 140/90 mmHg. Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery were measured baseline at the time of acute severe hypertension and repeated after control of blood pressure, to assess the changes in maternal hemodynamics if any with labetalol or nifedipine.
RESULTS


When evaluating right uterine artery Doppler parameters, a trend to increase in PI and RI was observed in those who received labetalol and nifedipine however the difference was not statistically significant. Whereas, while evaluating left uterine artery indices a trend to decrease PI was seen in nifedipine group but the difference was not statistically significant. On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
CONCLUSION


The use of labetalol and nifedipine were not related to any significant changes in maternal Doppler, which is reassuring about the safety of these drugs when treating acute severe hypertension in pregnancy.",2020,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","['thirty pregnant women with gestational age between 28 and 40\xa0weeks in acute severe hypertension (more than or equal to 160/105\xa0mmHg', 'acute severe hypertension', 'acute severe hypertension after treatment with intravenous']","['labetalol or nifedipine', 'nifedipine', 'labetalol or oral nifedipine', 'intravenous labetalol or oral nifedipine', 'labetalol and nifedipine', 'labetalol']","['renal artery indices', 'Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery', 'PI and RI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",30.0,0.0341283,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Department of Obstetrics & Gynaecology, YSPGMC, Nahan, India. Electronic address: thakurmonika126@gmail.com.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gainder', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Saha', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, PGIMER, Chandigarh, India.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.014']
1103,32570480,A Study of the Possibility of Detecting Pediatric Mild Developmental Delay Through a Serious Game: A Randomized Cluster Trial in Cambodia.,"Although early diagnosis of developmental delay is important, there are challenges in identifying cognitive status in developing countries because of limited human and financial resources to perform diagnostic tests. Moreover, diagnosis stability of developmental delay in children using neuropsychological tests (NPTs) can remain unsettled. The aim of this study is (1) to verify the effectiveness of a serious game (DoBrain), (2) to identify existing inconsistencies between NPTs, and (3) to explore the potential of the serious game as a complement to diagnostic tools. Eligible children who had completed results of NPTs were selected (n=119/235; 116/235; case, control). With these children's scores, we performed the Mann- Whitney U test to investigate the effectiveness of the serious game by comparing the improvement of scores in both groups. Among the participants, we additionally selected a case group to identify the potential of the serious game for detecting mild developmental delay. Using the results of the CGI-S as a baseline, we defined the participants whose scores indicated more than mild illness (>=2 points) in at least one area as the suspected group. The score improvement related to memory in case group was greater than that of the control group (p<0.05). Furthermore, four of the NPTs were not inconsistent, and the sensitivity/specificity of DDST-II was the highest score considering CGI-S results as the ground truth (0.43; 0.96). Additionally, games measuring discrimination, velocity, memory, and spatial perception showed statistical significance (p<0.05). This study verifies that the serious game can help specific cognitive areas and suggests that the serious game could be used as a low-cost and unconstrained spatiotemporal alternative to NPTs.",2020,The score improvement related to memory in case group was greater than that of the control group (p<0.05).,"['Pediatric Mild Developmental Delay Through a Serious Game', 'Eligible children who had completed results of NPTs were selected (n=119/235; 116/235; case, control']",['serious game (DoBrain'],"['games measuring discrimination, velocity, memory, and spatial perception', 'mild illness']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0037744', 'cui_str': 'Space Perception'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",,0.0218095,The score improvement related to memory in case group was greater than that of the control group (p<0.05).,"[{'ForeName': 'Ho Heon', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Systems Informatics Yonsei University College of Medicine, Korea.'}, {'ForeName': 'Hong Wook', 'Initials': 'HW', 'LastName': 'Kwon', 'Affiliation': 'Department of Biomedical Systems Informatics Yonsei University College of Medicine, Korea.'}, {'ForeName': 'Sambath', 'Initials': 'S', 'LastName': 'Kao', 'Affiliation': 'National Pediatric Hospital, Cambodia.'}, {'ForeName': 'Hyuk-Sang', 'Initials': 'HS', 'LastName': 'Sohn', 'Affiliation': 'Kyung Hee University, Korea.'}, {'ForeName': 'Joohye', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Busan Presbyterian University, Korea.'}, {'ForeName': 'Yejin', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Dobrain inc., Korea.'}, {'ForeName': 'Doora', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Dobrain inc., Korea.'}, {'ForeName': 'Mirae', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Dobrain inc., Korea.'}, {'ForeName': 'Yu Rang', 'Initials': 'YR', 'LastName': 'Park', 'Affiliation': 'Department of Biomedical Systems Informatics Yonsei University College of Medicine, Korea.'}]",Studies in health technology and informatics,['10.3233/SHTI200258']
1104,32571403,"Correction to: Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['adult patients with phenylketonuria (the PICO study'],"['phenylalanine', 'placebo']","['cognitive, cerebral, and neurometabolic parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.158712,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Trepp', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Raphaela', 'Initials': 'R', 'LastName': 'Muri', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Abgottspon', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Bosanska', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hochuli', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Slotboom', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rummel', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kreis', 'Affiliation': 'Magnetic Resonance Methodology Unit, Department of Biomedical Research & Institute of Interventional, Diagnostic and Pediatric Radiology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Regula', 'Initials': 'R', 'LastName': 'Everts', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland. regula.everts@insel.ch.'}]",Trials,['10.1186/s13063-020-04489-7']
1105,32571602,"Exercise handout and one-on-one hand therapy for management of stiffness after plaster cast immobilization of simple phalangeal and metacarpal fractures in children: A randomized, noninferiority trial.","STUDY DESIGN


This is a noninferior, single-blind, randomized controlled trial.
INTRODUCTION


Joint stiffness is common after plaster cast immobilization for simple phalanx and metacarpal fractures in children. The limited literature suggests this joint stiffness in children resolves without one-on-one therapy; however, without robust studies confirming that there is no detrimental effect from withdrawing treatment, many children are still referred.
PURPOSE OF THE STUDY


The purpose of this study was to determine if an educational handout for self-management of stiffness is noninferior to one-on-one hand therapy for achieving full range of motion (ROM).
METHODS


Participants were randomly assigned to group one who received the handout or group two who received hand therapy in addition to the handout. The ROM was measured by composite flexion and total active motion (TAM). The noninferiority margin was 10% difference between the two groups in the proportion of participants who achieved full ROM at two weeks after cast removal.
RESULTS


Sixty participants in each group completed the study. Group difference for composite flexion was 1.7% (95% CI: -3.9% to 7.2%), demonstrating noninferiority. Group difference for TAM was inconclusive at 8.3% (95% CI: -2.1% to 18.7%). Sensitivity analysis adjusting for participants with full composite flexion at the baseline resulted in the group difference for composite flexion of 3.1% (95% CI: -3.6% to 9.8%), maintaining noninferiority, but group difference for TAM at 10.4% (95% CI: 0.0% to 20.9%), was inconclusive with the handout group significantly worse.
CONCLUSION


An educational handout is noninferior to hand therapy for achieving full ROM in composite flexion but not TAM. This needs to be taken into consideration for changing clinical practise.",2020,Group difference for TAM was inconclusive at 8.3% (95% CI: -2.1% to 18.7%).,"['simple phalangeal and metacarpal fractures in children', 'Participants', 'simple phalanx and metacarpal fractures in children', 'Sixty participants in each group completed the study']","['TAM', 'Exercise handout and one-on-one hand therapy']","['composite flexion', 'full ROM', 'composite flexion and total active motion (TAM']","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0272677', 'cui_str': 'Fracture of metacarpal bone'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222682', 'cui_str': 'Phalanx structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}]",,0.163378,Group difference for TAM was inconclusive at 8.3% (95% CI: -2.1% to 18.7%).,"[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia. Electronic address: Cheng.Tan@health.wa.gov.au.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Depiazzi', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Department of Clinical Research and Education, Child Adolescent Health Service, Perth, Western Australia, Australia.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Blennerhassett', 'Affiliation': 'Department of Plastics and Reconstructive Surgery, Child and Adolescent Health Service, Perth, Western Australia, Australia.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'Department of Plastics and Reconstructive Surgery, Child and Adolescent Health Service, Perth, Western Australia, Australia.'}, {'ForeName': 'Noula', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia.""}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.017']
1106,31411147,Association Between User Engagement of a Mobile Health App for Gout and Improvements in Self-Care Behaviors: Randomized Controlled Trial.,"BACKGROUND


Mobile health (mHealth) apps represent a promising approach for improving health outcomes in patients with chronic illness, but surprisingly few mHealth interventions have investigated the association between user engagement and health outcomes. We aimed to examine the efficacy of a recommended, commercially available gout self-management app for improving self-care behaviors and to assess self-reported user engagement of the app in a sample of adults with gout.
OBJECTIVE


Our objective was to examine differences in self-reported user engagement between a recommended gout app (treatment group) and a dietary app (active control group) over 2 weeks as well as to examine any differences in self-care behaviors and illness perceptions.
METHODS


Seventy-two adults with gout were recruited from the community and three primary and secondary clinics. Participants were randomized to use either Gout Central (n=36), a self-management app, or the Dietary Approaches to Stop Hypertension Diet Plan (n=36), an app based on a diet developed for hypertension, for 2 weeks. The user version of the Mobile Application Rating Scale (uMARS, scale: 1 to 5) was used after the 2 weeks to assess self-reported user engagement, which included an open-ended question. Participants also completed a self-report questionnaire on self-care behaviors (scale: 1-5 for medication adherence and diet and 0-7 for exercise) and illness perceptions (scale: 0-10) at baseline and after the 2-week trial. Independent samples t tests and analysis of covariance were used to examine differences between groups at baseline and postintervention.
RESULTS


Participants rated the gout app as more engaging (mean difference -0.58, 95% CI -0.96 to -0.21) and more informative (mean difference -0.34, 95% CI -0.67 to -0.01) than the dietary app at the 2-week follow-up. The gout app group also reported a higher awareness of the importance of gout (mean difference -0.64, 95% CI -1.27 to -0.003) and higher knowledge/understanding of gout (mean difference -0.70, 95% CI -1.30 to -0.09) than the diet app group at follow-up. There were no significant differences in self-care behaviors between the two groups postintervention. The gout app group also demonstrated stronger negative beliefs regarding the impact of gout (mean difference -2.43, 95% CI -3.68 to -1.18), stronger beliefs regarding the severity of symptoms (mean difference -1.97, 95% CI -3.12 to -0.82), and a stronger emotional response to gout (mean difference -2.38, 95% CI -3.85 to -0.90) at follow-up. Participant feedback highlighted the importance of tracking health-related information, customizing to the target group/individual, providing more interactive features, and simplifying information.
CONCLUSIONS


Participants found the commercially available gout app more engaging. However, these findings did not translate into differences in self-care behaviors. The gout app group also demonstrated stronger negative illness perceptions at the follow-up. Overall, these findings suggest that the development of gout apps would benefit from a user-centered approach with a focus on daily, long-term self-care behaviors as well as modifying illness beliefs.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617001052325; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373217.",2019,"The gout app group also reported a higher awareness of the importance of gout (mean difference -0.64, 95% CI -1.27 to -0.003) and higher knowledge/understanding of gout (mean difference -0.70, 95% CI -1.30 to -0.09) than the diet app group at follow-up.","['adults with gout', 'patients with chronic illness', 'Self-Care Behaviors', 'Seventy-two adults with gout were recruited from the community and three primary and secondary clinics']","['self-report questionnaire on self-care behaviors (scale: 1-5 for medication adherence and diet and 0-7 for exercise', 'Gout Central', 'self-management app, or the Dietary Approaches to Stop Hypertension Diet Plan']","['stronger negative illness perceptions', 'stronger beliefs regarding the severity of symptoms', 'Mobile Application Rating Scale', 'higher knowledge/understanding of gout', 'self-care behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0222045'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",72.0,0.135377,"The gout app group also reported a higher awareness of the importance of gout (mean difference -0.64, 95% CI -1.27 to -0.003) and higher knowledge/understanding of gout (mean difference -0.70, 95% CI -1.30 to -0.09) than the diet app group at follow-up.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kiralee', 'Initials': 'K', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anel', 'Initials': 'A', 'LastName': 'Kieser', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Arroll', 'Affiliation': 'General Practice and Primary Healthcare, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Bone and Joint Research Group, Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",JMIR mHealth and uHealth,['10.2196/15021']
1107,31374537,Number line unidimensionality is a critical feature for promoting fraction magnitude concepts.,"Children's ability to estimate fractions on a number line is strongly related to algebra and overall high school math achievement, and number line training leads to better fraction magnitude comparisons compared with area model training. Here, we asked whether unidimensionality is necessary for the number line to promote fraction magnitude concepts and whether left-to-right orientation and labeled endpoints are sufficient. We randomly assigned second- and third-graders (N = 148) to one of four 15-min one-on-one, experimenter-led trainings. Three number line trainings had identical scripts, where the experimenter taught children to segment and shade the number line along the horizontal dimension. The number line conditions varied only in the vertical dimension of the training number line: pure unidimensional number line (17.5 cm horizontal line), hybrid unidimensional number line (17.5 × 0.6 cm rectangle), and square number line (17.5 × 17.5 cm). In the area model condition, children were taught to segment and shade a square (17.5 × 17.5 cm) along both dimensions. The conditions significantly differed in posttest fraction magnitude comparison accuracy (a transfer task), controlling for pretest accuracy, reading achievement, and age. In preregistered analyses, the hybrid unidimensional number line condition significantly outperformed the square area model condition and the square number line condition. In exploratory analyses accounting for training protocol fidelity, these results held and the pure unidimensional number line also outperformed the area model condition on fraction magnitude comparisons. We argue that unidimensionality is a critical feature of the number line for promoting fraction magnitude concepts because it aligns with a key concept-that real numbers, including fractions, can be ordered along a single dimension.",2019,"Children's ability to estimate fractions on a number line is strongly related to algebra and overall high school math achievement, and number line training leads to better fraction magnitude comparisons compared with area model training.",[],[],"['posttest fraction magnitude comparison accuracy (a transfer task), controlling for pretest accuracy, reading achievement, and age']",[],[],"[{'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.0200516,"Children's ability to estimate fractions on a number line is strongly related to algebra and overall high school math achievement, and number line training leads to better fraction magnitude comparisons compared with area model training.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Gunderson', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA 19122, USA. Electronic address: liz.gunderson@temple.edu.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Hamdan', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Psychology, Boston College, Chestnut Hill, MA 02467, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bartek', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA 19122, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.06.010']
1108,32271041,Switching cluster membership in cluster randomized control trials: Implications for design and analysis.,"Randomized control trials (RCTs) often use clustered designs, where intact clusters (such as classroom, schools, or treatment centers) are randomly assigned to treatment and control conditions. Hierarchical linear models (HLMs) are used almost universally to estimate the effects in such experiments. While study designs that utilize intact clusters have many potential advantages, there is little guidance in the literature on how to respond when cluster switching induces noncompliance with the randomization protocol. In the presence of noncompliance the intent-to-treat (ITT) effect becomes the estimand of interest. When fitting the HLM, these individuals who switch clusters can be assigned to either their as-assigned cluster (the cluster they belonged to at the time of randomization) or their as-treated cluster (the cluster they belonged to at the time the outcome was collected). We show analytically and via simulation, that using the as-treated cluster in HLM will bias the estimate of the ITT effect and using the as-assigned cluster will bias the standard error estimates when heterogeneity among clusters is because of heterogeneity in treatment effects. We show that using linear regression with two-way cluster adjusted standard errors can yield unbiased ITT estimates and consistent standard errors regardless of the source of the random effects. We recommend this method replace HLM as the method of choice for testing intervention effects with cluster-randomized trials with noncompliance and cluster switching. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"We show analytically and via simulation, that using the as-treated cluster in HLM will bias the estimate of the ITT effect and using the as-assigned cluster will bias the standard error estimates when heterogeneity among clusters is because of heterogeneity in treatment effects.",[],[],[],[],[],[],,0.0549137,"We show analytically and via simulation, that using the as-treated cluster in HLM will bias the estimate of the ITT effect and using the as-assigned cluster will bias the standard error estimates when heterogeneity among clusters is because of heterogeneity in treatment effects.","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Schweig', 'Affiliation': 'RAND Corporation.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Pane', 'Affiliation': 'RAND Corporation.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McCaffrey', 'Affiliation': 'Educational Testing Service.'}]",Psychological methods,['10.1037/met0000258']
1109,32494763,The effectiveness of counseling based on acceptance and commitment therapy on body image and self-esteem in polycystic ovary syndrome: An RCT.,"Background


Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders known with irregular menstruation, hirsutism, alopecia, obesity, infertility, and acne. These symptoms cause a negative effect on the satisfaction of body image, self-esteem, and quality of life in such patients. Recent studies emphasize the need to consider the psychological problems in these women and also the need for appropriate interventions.
Objective


The aim of this study was to determine the effectiveness of group counseling based on acceptance and commitment therapy (ACT) on body image and self-esteem in patients with PCOS.
Materials and Methods


In this randomized controlled trial, 52 women with PCOS were randomly allocated to intervention and control groups (n = 26/each) using the table of random numbers. Group counseling based on the ACT was held in eight sessions of 90 min once a week for the intervention group. The demographic questionnaire, Littleton development of the body image concern inventory and Rosenberg self-esteem scale were completed in both groups before, immediately after, and one month after the intervention.
Results


The mean scores of body image concern (p = 0.001) and self-esteem (p  ≤  0.001) in the intervention group after the intervention and follow-up were significantly different from the control group.
Conclusion


Based on the findings of this study, use of cognitive-behavioral therapies in health care centers is recommended as a complementary method.",2020,"The mean scores of body image concern (p = 0.001) and self-esteem (p  ≤  0.001) in the intervention group after the intervention and follow-up were significantly different from the control group.
","['health care centers', 'polycystic ovary syndrome', 'patients with PCOS', '\n\n\nPolycystic ovary syndrome (PCOS', '52 women with PCOS']","['cognitive-behavioral therapies', 'group counseling based on acceptance and commitment therapy (ACT']","['satisfaction of body image, self-esteem, and quality of life', 'mean scores of body image concern', 'self-esteem', 'demographic questionnaire, Littleton development of the body image concern inventory and Rosenberg self-esteem scale', 'body image and self-esteem']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}]",52.0,0.0844013,"The mean scores of body image concern (p = 0.001) and self-esteem (p  ≤  0.001) in the intervention group after the intervention and follow-up were significantly different from the control group.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Faculty of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ghadiri-Anari', 'Affiliation': 'Department of Internal Medicine, Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dehghani', 'Affiliation': 'Department of Biostatistics and Epidemiology, Public Health School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Reza Vaziri', 'Affiliation': 'Clinical Psychologist, Private Counseling Center of Negaresh, Yazd, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Enjezab', 'Affiliation': 'Department of Midwifery, Research Center for Nursing and Midwifery Care, Faculty of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i4.6887']
1110,32494767,Effect of adding letrozole to gonadotropin on in vitro fertilization outcomes: An RCT.,"Background


Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth.
Objective


This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders.
Materials and Methods


In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins.
Results


Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
Conclusion


Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.",2020,"There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
","['normal responders', '100 normal responder women candidate for controlled ovarian stimulation']","['letrozole to gonadotropin', 'letrozole', 'conventional antagonist protocol']","['number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins', 'Estradiol level', 'fertilization rate and chemical and clinical pregnancy rates', 'vitro fertilization outcomes', 'total gonadotropin consumption', 'endometrial thickness', 'number of MII oocytes']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",100.0,0.0569174,"There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eftekhar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Saeed', 'Affiliation': 'Afzalipour Hospital, Kerman University of Medical Science, Kerman, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i4.6891']
1111,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND


There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS


In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS


At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION


Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
1112,32506371,Repeat radiation with bevacizumab and minocycline in bevacizumab-refractory high grade gliomas: a prospective phase 1 trial.,"INTRODUCTION


There are no effective treatments for gliomas after progression on radiation, temozolomide, and bevacizumab. Microglia activation may be involved in radiation resistance and can be inhibited by the brain penetrating antibiotic minocycline. In this phase 1 trial, we examined the safety and effect on survival, symptom burden, and neurocognitive function of reirradiation, minocycline, and bevacizumab.
METHODS


The trial used a 3 + 3 design for dose escalation followed by a ten person dose expansion. Patients received reirradiation with dosing based on radiation oncologist judgment, bevacizumab 10 mg/kg IV every two weeks, and oral minocycline twice a day. Symptom burden was measured using MDASI-BT. Neurocognitive function was measured using the COGSTATE battery.
RESULTS


The maximum tolerated dose of minocycline was 400 mg twice a day with no unexpected toxicities. The PFS3 was 64.6%, and median overall survival was 6.4 months. Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression.
CONCLUSIONS


Minocycline 400 mg orally twice a day with bevacizumab and reirradiation is well tolerated by physician and patient reported outcomes in people with gliomas that progress on bevacizumab.",2020,"Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression.
",['refractory high grade gliomas'],"['temozolomide, and bevacizumab', 'bevacizumab', 'Minocycline 400\xa0mg orally twice a day with bevacizumab and reirradiation', 'minocycline', 'bevacizumab and minocycline']","['toxicities', 'median overall survival', 'Neurocognitive function', 'Symptom burden', 'Symptom burden and neurocognitive function', 'survival, symptom burden, and neurocognitive function of reirradiation, minocycline, and bevacizumab']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",,0.0873686,"Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression.
","[{'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Cohen', 'Affiliation': 'Division of Medical Oncology, University of Utah School of Medicine, Salt Lake City, UT, USA. Adam.cohen@hci.utah.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Anker', 'Affiliation': 'Division of Radiation Oncology, University of Vermont Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Burt', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Shrieve', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Salzman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Jensen', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Boucher', 'Affiliation': 'Division of Medical Oncology, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03551-3']
1113,32686440,[Effect of a Mediterranean-pattern diet on the metabolic response secondary to weight loss; role of the single nucleotide polymorphism (rs16147) of neuropeptide Y].,"Introduction


Background and aims: intervention studies that evaluate the effect of rs16147 on metabolic response and weight change after dietary intervention are scarce. We propose to evaluate the role of the rs16147 genetic variant in the metabolic effects produced by a hypocaloric Mediterranean-pattern diet with high content of omega-9. Material and methods: a sample of 363 obese subjects was recruited. At the baseline visit the patients were randomly assigned to one of two hypocaloric diets for 12 weeks (diet M, Mediterranean pattern; diet C, standard hypocaloric). All patients, at baseline and at 12 weeks, had biochemical and anthropometric variables measured, and genotyping performed for the rs16147 variant. Results: in all subjects, and with both diets, the parameters of adiposity, blood pressure, and circulating leptin improved. In obese subjects with allele (A) insulin levels (GG vs. GA + AA) (-0.9 ± 1.1 IU/L vs. -4.4 ± 1.0 IU/L; p = 0.01) and HOMA-IR (-0.3 ± 0.1 units vs. -1.2 ± 0.3 units; p = 0.02) decreased significantly with diet M. Subjects carrying the minor allele showed a significant decrease in basal insulin levels (GG vs. GA + AA) (0.7 ± 0.3 IU/L vs. -2.2 ± 0.9 IU/L: p = 0.02) and HOMA-IR (-0.3 ± 0.2 units vs. -0.7 ± 0.1 units: p = 0.01) after diet C. This decrease in circulating insulin and HOMA-IR levels in patients with allele A was significantly higher with diet M than with diet C. Conclusions: the A allele of the rs16147 variant produces a better metabolic response in terms of insulin resistance and basal insulin secondary to weight loss with two different hypocaloric diets in obese subjects, with improvement being higher with the Mediterranean diet.",2020,"This decrease in circulating insulin and HOMA-IR levels in patients with allele A was significantly higher with diet M than with diet C.
CONCLUSIONS


the A allele of the rs16147 variant produces a better metabolic response in terms of insulin resistance and basal insulin secondary to weight loss with two different hypocaloric diets in obese subjects, with improvement being higher with the Mediterranean diet.","['obese subjects', 'a sample of 363 obese subjects was recruited']","['Mediterranean-pattern diet', 'hypocaloric Mediterranean-pattern diet with high content of omega-9', 'hypocaloric diets for 12 weeks (diet M, Mediterranean pattern; diet C, standard hypocaloric']","['circulating insulin and HOMA-IR levels', 'adiposity, blood pressure, and circulating leptin improved', 'basal insulin levels', 'metabolic response and weight change']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",363.0,0.0271651,"This decrease in circulating insulin and HOMA-IR levels in patients with allele A was significantly higher with diet M than with diet C.
CONCLUSIONS


the A allele of the rs16147 variant produces a better metabolic response in terms of insulin resistance and basal insulin secondary to weight loss with two different hypocaloric diets in obese subjects, with improvement being higher with the Mediterranean diet.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo Martín', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola Jáuregui', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'López Gómez', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Gómez Hoyos', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortolá Buigues', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Delgado', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Díaz', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Torres Torres', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'de Luis Román', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}]",Nutricion hospitalaria,['10.20960/nh.02941']
1114,32686444,ACYL-CoA synthetase long-chain 5 polymorphism is associated with weight loss and metabolic changes in response to a partial meal-replacement hypocaloric diet.,"Introduction


Aims:to analyze the effects of the rs2419621 genetic variant of the ACSL5 gene on weight change and metabolic parameters after a partial meal-replacement hypocaloric diet. Methods: this was a non-randomized, single-treatment study with a formula-diet in 44 obese subjects with body mass index (BMI) greater than 35 kg/m2. Patients received nutritional education and a modified diet with two intakes of a normocaloric hyperproteic formula during 3 months. Anthropometric parameters and biochemical profile were measured at baseline and after 3 months. The rs2419621 variant of the ACSL5 gene was assessed using real-time polymerase chain reaction. Results: T-allele carriers showed greater improvement in body weight (CC vs. CT + TT; -7.4 ± 2.1 kg vs. -9.3 ± 1.8 kg; p = 0.01), body mass index (-3.1 ± 0.4 kg/m2 vs. -3.4 ± 0.5 kg/m2; p = 0.02), fat mass (-5.2 ± 1.4 kg vs. -6.4 ± 1.2 kg; p = 0.01) and waist circumference (-6.1 ± 1.1 cm vs. -8.6 ± 0.8 cm; p = 0.02) than non-T-allele carriers. Only subjects with the T allele showed significant improvement in triglyceride levels (-4.6 ± 2.4 md/dL vs. -14.4 ± 2.3 mg/dL; p = 0.01). Finally, improvements in insulin (-2.0 ± 0.3 mU/L vs. -4.5 ± 0.5 mU/L; p = 0.01) and HOMA-IR (-0.4 ± 0.2 units vs. -1.3 ± 0.3 units; p = 0.02) were higher in T-allele carriers than in non-T-allele carriers. Conclusions: our data suggest that the genetic variant (rs2419621) of the ACSL5 gene is associated with diet response after a partial-meal replacement intervention, with greater improvements in adiposity and biochemical parameters in subjects with the T allele.",2020,"RESULTS


T-allele carriers showed greater improvement in body weight (CC vs. CT + TT; -7.4 ± 2.1 kg vs. -9.3 ± 1.8 kg; p = 0.01), body mass index (-3.1 ± 0.4 kg/m2 vs. -3.4 ± 0.5 kg/m2; p = 0.02), fat mass (-5.2 ± 1.4 kg vs. -6.4 ± 1.2 kg; p = 0.01) and waist circumference (-6.1 ± 1.1 cm vs. -8.6 ± 0.8 cm; p = 0.02) than non-T-allele carriers.","['44 obese subjects with body mass index (BMI) greater than 35 kg/m2', 'subjects with the T allele']","['formula-diet', 'nutritional education and a modified diet with two intakes of a normocaloric hyperproteic formula']","['waist circumference', 'Anthropometric parameters and biochemical profile', 'body mass index', 'body weight', 'triglyceride levels', 'HOMA-IR', 'adiposity and biochemical parameters', 'weight change and metabolic parameters']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0452264', 'cui_str': 'Therapeutic diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",44.0,0.114747,"RESULTS


T-allele carriers showed greater improvement in body weight (CC vs. CT + TT; -7.4 ± 2.1 kg vs. -9.3 ± 1.8 kg; p = 0.01), body mass index (-3.1 ± 0.4 kg/m2 vs. -3.4 ± 0.5 kg/m2; p = 0.02), fat mass (-5.2 ± 1.4 kg vs. -6.4 ± 1.2 kg; p = 0.01) and waist circumference (-6.1 ± 1.1 cm vs. -8.6 ± 0.8 cm; p = 0.02) than non-T-allele carriers.","[{'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola Jáuregui', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'López Gómez', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo Martín', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Torres Torres', 'Affiliation': 'Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Gómez Hoyos', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortolá Buigues', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Delgado', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'de Luis Román', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}]",Nutricion hospitalaria,['10.20960/nh.03019']
1115,32513251,"Correction to: Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD).",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"['HER2-positive, locally advanced or metastatic breast cancer']","['Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane']",[],"[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]",[],,0.0233853,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, 241-8515, Japan. tyamashita@kcch.jp.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Department of Medical Oncology, Fukeushima Medical University, 1 Hikarigaoka Fukushima, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Araki', 'Affiliation': 'Department of Breast Surgery, Gunma Prefectural Cancer Center, 617-1 Takahayashinishicho, Ota, Gunma, 373-8550, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Breast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Breast Surgery, NHO Hokkaido Cancer Center, 2-3-54 Yonjyo Kikusui Shiraishi-ku, Sapporo-shi, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Department of Medical Oncology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, Tokyo, 142-8666, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, 431-3192, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kitada', 'Affiliation': 'Breast Disease Center, Asahikawa Medical University Hospital, 1-1 Higashi 2-jyo 1-chome, Midorigaoka, Asahikawa-shi, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Breast Surgery, St. Marianna University School of Medicine Hospital, 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Breast Surgical Oncology, Sagara Hospital, 3-31 Matsubaracho Kagoshima-shi, Kagoshima, 892-0833, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Breast and Endocrine Surgical Oncology, Tohoku University Hospital, 1-1 Seiryocho Aoba-ku, Sendai-shi, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Iwasa', 'Affiliation': 'Oncology Internal Medicine, Kindai University Hospital, 377-2 Ohnohigashi Sayama-shi Osaka, Osaka, 589-8511, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kadoya', 'Affiliation': 'Breast Surgery, Hiroshima University Hospital, 1-2-3 Kasumi Minami-ku Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Tsuguo', 'Initials': 'T', 'LastName': 'Iwatani', 'Affiliation': 'Department of Breast Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Eisai Co., Ltd., 4-6-10 Koishikawa Bunkyo-ku, Tokyo, 112-8088, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine Kyoto University, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}]",Trials,['10.1186/s13063-020-04408-w']
1116,32518696,"Comment on ""Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial"".",,2020,,['Chronic Obstructive Pulmonary Disease'],['Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique'],[],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",[],,0.0301672,,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bordoni', 'Affiliation': 'Foundation Don Carlo Gnocchi IRCCS, Department of Cardiology, Institute of Hospitalization and Care with Scientific, Via Capecelatro 66, Milan 20100, Italy.'}]",Pulmonary medicine,['10.1155/2020/7437019']
1117,32530426,Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial.,"BACKGROUND


WHO recommends that men who have sex with men (MSM) receive gonorrhoea and chlamydia testing, but many evidence-based preventive services are unaffordable. The pay-it-forward strategy offers an individual a gift (eg, a test for sexually transmitted diseases) and then asks whether they would like to give a gift (eg, a future test) to another person. This study examined the effectiveness of a pay-it-forward programme to increase gonorrhoea and chlamydia testing among MSM in China.
METHODS


We did a randomised controlled superiority trial at three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China. We included MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing. Restricted randomisation was done using computer-generated permuted blocks. 30 groups were randomised into three arms (1:1:1): a pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing and then asked whether they would like to donate for testing of prospective participants, a pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing was offered at ¥150 (US$22). There was no masking to arm assignment. The primary outcome was gonorrhoea and chlamydia test uptake ascertained by administrative records. We used generalised estimating equations to estimate intervention effects with one-sided 95% CIs and a prespecified superiority margin of 20%. The trial is registered with ClinicalTrials.gov, NCT03741725.
FINDINGS


Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis. 101 were randomly assigned to the pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group. Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm. The estimated difference in test uptake between the pay-it-forward and standard-of-care group was 38·4% (95% CI lower bound 28·4%). Among men in the pay-it-forward arm, 54 of 57 (95%) chose to donate to support testing for others.
INTERPRETATION


The pay-it-forward strategy can increase gonorrhoea and chlamydia testing uptake among Chinese MSM and could be a useful tool for scaling up preventive services that carry a mandatory fee.
FUNDING


US National Institute of Health; Special Programme for Research and Training in Tropical Diseases, sponsored by UNICEF, UNDP, World Bank, and WHO; the National Key Research and Development Program of China; Doris Duke Charitable Foundation; and Social Entrepreneurship to Spur Health.",2020,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","['MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing', 'men who have sex with men in China', 'MSM in China', 'three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China', 'Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis', 'men who have sex with men (MSM']","['pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing', 'pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group', 'Pay-it-forward gonorrhoea and chlamydia testing', 'pay-it-forward programme', 'pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing']",['gonorrhoea and chlamydia test uptake'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",301.0,0.098425,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Tiange P', 'Initials': 'TP', 'LastName': 'Zhang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Loyola University Chicago Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, VIC, Australia; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forastiere', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA; Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Li', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Mi', 'Affiliation': 'Blued, Beijing, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Weizan', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vickerman', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK. Electronic address: jdtucker@med.unc.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30172-9']
1118,32533228,Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).,"PURPOSE


To investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer.
METHODS


This randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2‑year overall survival (OS). Arm A was considered insufficiently active if 2‑year OS was ≤40% (null hypothesis = H 0 ), and promising if the lower limit of the 95% confidence interval was >45%. If that lower limit was >40%, H 0  was rejected. Secondary objectives included progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity. The study was terminated early after 74 patients; 68 patients were evaluable.
RESULTS


Two-year OS was 71% in arm A (95% CI: 55-87%) vs. 53% in arm B (95% CI: 36-71%); H 0  was rejected. Median OS was 49.1 vs. 24.1 months (p = 0.147). Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21). At 2 years, PFS was 56% vs. 44%, LC 84% vs. 72%, and MFS 74% vs. 54%. HRs were 0.51 (0.25-1.04) for progression, 0.43 (0.13-1.40) for locoregional failure, and 0.43 (0.17-1.05) for distant metastasis. Overall response was 81% vs. 69% (p = 0.262). Twenty-six and 27 patients, respectively, experienced at least one toxicity grade ≥3 (p = 0.573). A significant difference was found for grade ≥3 allergic reactions (12.5% vs. 0%, p = 0.044).
CONCLUSION


Given the limitations of this trial, radiochemotherapy plus cetuximab was feasible. There was a trend towards improved PFS and MFS. Larger studies are required to better define the role of cetuximab for unresectable esophageal cancer.",2020,Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21).,"['74\xa0patients; 68\xa0patients were evaluable', 'unresectable esophageal cancer']","['cetuximab', 'radiochemotherapy', 'radiochemotherapy plus cetuximab', 'Radiochemotherapy with or without cetuximab']","['PFS', 'Median OS', 'efficacy and toxicity', 'PFS and MFS', 'locoregional failure', 'progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity', '2‑year overall survival (OS', 'Overall response', 'grade ≥3 allergic reactions', 'Hazard ratio (HR) for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.261344,Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21).,"[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Rades', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee\xa0160, 23562, Lübeck, Germany. Rades.Dirk@gmx.net.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bartscht', 'Affiliation': 'Department of Hematology and Oncology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hunold', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidberger', 'Affiliation': 'Department of Radiation Oncology, Johannes-Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'König', 'Affiliation': 'Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Belka', 'Affiliation': 'Department of Radiation Oncology, Ludwig-Maximillians University, Munich, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Homann', 'Affiliation': 'Medical Department II, Klinikum Wolfsburg, Wolfsburg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Spillner', 'Affiliation': 'Department of Radiation Oncology, Eberhard-Karls University, Tübingen, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Petersen', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuhnt', 'Affiliation': 'Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Ridwelski', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Karcher-Kilian', 'Affiliation': 'Practice for Gastroenterology, Diabetology, Oncology and Hematology Lübeck, Lübeck, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kranich', 'Affiliation': 'Gesellschaft für Studienmanagement und Onkologie mbH, Hamburg, Germany.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Männikkö', 'Affiliation': 'Pharma Ltd, Turku, Finland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Scottsdale, AZ, USA.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Maderer', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01646-4']
1119,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND


Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate.
OBJECTIVE


This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game.
PARTICIPANTS AND SETTING


The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia.
METHOD


All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34).
RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not.
CONCLUSIONS


This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569']
1120,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
1121,32574223,A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults.,"PURPOSE


Nitrate (NO3-), through its conversion to nitrite (NO2-) and nitric oxide, has been shown to increase exercise tolerance in healthy younger adults and older diseased patients. Nitrate's effect in well-trained middle to older-aged adults has not been studied. Therefore, the purpose of this investigation was to examine the effects of a NO3- rich beverage on submaximal constant work rate exercise time in well-trained middle to older-aged adults.
METHODS


This was a randomized controlled cross-over trial with 15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments (NO3- rich beverage then placebo or placebo then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed.
RESULTS


The NO3- rich beverage increased plasma NO3- and NO2- levels by 260 μM and 0.47 μM, respectively (p<0.001). Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (1130±151 vs 1060±132 sec, respectively). Changes in exercise time between the two conditions ranged from a 55% improvement to a 40% decrease with the NO3- rich beverage. Oxygen consumption and rating of perceived exertion were not significantly different between the two conditions.
CONCLUSION


In middle to older-aged well-trained adults, NO3- supplementation has non-significant, albeit highly variable, effects on exercise tolerance. ClinicalTrials.gov Identifier: NCT03371966.",2020,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"['healthy younger adults and older diseased patients', 'well-trained middle to older-aged adults', 'well-trained middle and older-aged adults', ""then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed"", '15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments']","['NO3- rich beverage then placebo or placebo', 'nitrate supplementation', 'NO3- rich beverage']","['exercise time', 'Exercise time', 'exercise tolerance', 'submaximal constant work rate exercise time', 'plasma NO3- and NO2- levels', 'Oxygen consumption and rating of perceived exertion']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.426141,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Macie S', 'Initials': 'MS', 'LastName': 'Fletcher', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Caleb G', 'Initials': 'CG', 'LastName': 'Jones', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Gauthier', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Summer L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Heinrich', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0235047']
1122,32575930,[Application of Endo-GIA stapler in laparoscopic radicalcystectomy].,"Objective:  To explore the application of Endo-GIA stapler in laparoscopic radical cystectomy, especially in the treatment of lateral bladder ligament, and to evaluate its clinical feasibility and practicability.  Methods:  A retrospective analysis of clinical data about 38 cases of laparoscopic radical cystectomy (LRC) treated in the Department of Urology, Chaoyang Hospital of Beijing and Cancer Hospital, Chinese Academy of Medical Sciences from July 2017 to June 2019 were conducted. The patients were divided into Endo-GIA stopler group(18 cases) and non-Endo-GIA stopler group (20 cases) according to whether Endo-GIA stapler were used. The basic clinical data, operation time of bladder lateral ligament, operation time of bladder lateral wall, operation time of bladder resection, amount of bleeding during operation, pathological data after operation and related indicators of recovery after operation were compared between the two groups.  Results:  All 38 patients underwent radical cystectomy (RC) successfully under 3-D laparoscopy without conversion to open surgery. The operation time of bladder lateral ligament in Endo-GIA stapler group was significantly shorter than that in non-Endo-GIA stapler group [(3.25±0.75) min vs (9.20±2.95) min,  P= 0.042]; the operation time of bladder lateral wall in Endo-GIA stapler group was significantly shorter than that in non-Endo-GIA stapler group [(8.06±1.66) min vs (14.30±3.37) min,  P= 0.016]. The operation time of cystectomy in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(47.06±4.70) min vs (61.60±14.91) min, P= 0.003]. The amount of bleeding in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(37.77±21.30) ml vs (114.50±39.80) ml,  P= 0.015]. The time of drainage tube removal in Endo-GIA group was significantly shorter than that in the non-Endo-GIA group [(5.83±1.54) d vs (7.30±3.00) d,  P= 0.002]. The length of post-hospitalization in Endo-GIA group was significantly shorter than that in the non-Endo-GIA group [(7.67±1.78) d vs (9.60±3.25) d, P= 0.036]. However, there was no significant difference in other basic clinical data, post-operative pathology and post-operative recovery related indicators.  Conclusions:  Laparoscopic radical cystectomy using Endo-GIA stapler device is safe and feasible. It is easy to operate, shorten the operation time significantly, and reduce the amount of bleeding. To a certain extent, it is conducive to the recovery of patients after operation to some extent, and worthy of clinical application.",2020,"The amount of bleeding in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(37.77±21.30) ml vs (114.50±39.80) ml,  P= 0.015].","['38 patients underwent', '38 cases of laparoscopic radical cystectomy (LRC) treated in the Department of Urology, Chaoyang Hospital of Beijing and Cancer Hospital, Chinese Academy of Medical Sciences from July 2017 to June 2019 were conducted']","['Endo-GIA stapler', 'Laparoscopic radical cystectomy using Endo-GIA stapler device', 'radical cystectomy (RC) successfully under 3-D laparoscopy without conversion to open surgery', 'non-Endo-GIA stopler group (20 cases) according to whether Endo-GIA stapler']","['operation time of cystectomy', 'operation time of bladder lateral ligament, operation time of bladder lateral wall, operation time of bladder resection, amount of bleeding during operation, pathological data after operation and related indicators of recovery', 'amount of bleeding', 'length of post-hospitalization', 'operation time of bladder lateral ligament', 'operation time of bladder lateral', 'time of drainage tube removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3494226', 'cui_str': 'Conversion to an Open Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0006205', 'cui_str': 'Broad ligament structure'}, {'cui': 'C0496828', 'cui_str': 'Malignant neoplasm of lateral wall of urinary bladder'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}]",,0.0197267,"The amount of bleeding in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(37.77±21.30) ml vs (114.50±39.80) ml,  P= 0.015].","[{'ForeName': 'Q X', 'Initials': 'QX', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'F Y', 'Initials': 'FY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Beijing Chao-yang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'X S', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Urology Institute of Shenzhen University, the Third Affiliated Hospital of Shenzhen University, Shenzhen Following Precision Medical Research Institute, Luohu Hospital Group, Shenzhen 518000, China.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Shi', 'Affiliation': 'Department of Urology, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'N Z', 'Initials': 'NZ', 'LastName': 'Xing', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20190925-02112']
1123,30685685,Survival and prognosis with osteosarcoma: outcomes in more than 2000 patients in the EURAMOS-1 (European and American Osteosarcoma Study) cohort.,"BACKGROUND


High-grade osteosarcoma is a primary malignant bone tumour mainly affecting children and young adults. The European and American Osteosarcoma Study (EURAMOS)-1 is a collaboration of four study groups aiming to improve outcomes of this rare disease by facilitating randomised controlled trials.
METHODS


Patients eligible for EURAMOS-1 were aged ≤40 years with M0 or M1 skeletal high-grade osteosarcoma in which case complete surgical resection at all sites was deemed to be possible. A three-drug combination with methotrexate, doxorubicin and cisplatin was defined as standard chemotherapy, and between April 2005 and June 2011, 2260 patients were registered. We report survival outcomes and prognostic factors in the full cohort of registered patients.
RESULTS


For all registered patients at a median follow-up of 54 months (interquartile range: 38-73) from biopsy, 3-year and 5-year event-free survival were 59% (95% confidence interval [CI]: 57-61%) and 54% (95% CI: 52-56%), respectively. Multivariate analyses showed that the most adverse factors at diagnosis were pulmonary metastases (hazard ratio [HR] = 2.34, 95% CI: 1.95-2.81), non-pulmonary metastases (HR = 1.94, 95% CI: 1.38-2.73) or an axial skeleton tumour site (HR = 1.53, 95% CI: 1.10-2.13). The histological subtypes telangiectatic (HR = 0.52, 95% CI: 0.33-0.80) and unspecified conventional (HR = 0.67, 95% CI: 0.52-0.88) were associated with a favourable prognosis compared with chondroblastic subtype. The 3-year and 5-year overall survival from biopsy were 79% (95% CI: 77-81%) and 71% (95% CI: 68-73%), respectively. For patients with localised disease at presentation and in complete remission after surgery, having a poor histological response was associated with worse outcome after surgery (HR = 2.13, 95% CI: 1.76-2.58). In radically operated patients, there was no good evidence that axial tumour site was associated with worse outcome.
CONCLUSIONS


In conclusion, data from >2000 patients registered to EURAMOS-1 demonstrated survival rates in concordance with institution- or group-level osteosarcoma trials. Further efforts are required to drive improvements for patients who can be identified to be at higher risk of adverse outcome. This trial reaffirms known prognostic factors, and owing to the large numbers of patients registered, it sheds light on some additional factors to consider.",2019,"The histological subtypes telangiectatic (HR = 0.52, 95% CI: 0.33-0.80) and unspecified conventional (HR = 0.67, 95% CI: 0.52-0.88) were associated with a favourable prognosis compared with chondroblastic subtype.","['April 2005 and June 2011, 2260 patients were registered', 'full cohort of registered patients', 'children and young adults', 'Patients eligible for EURAMOS-1 were aged ≤40 years with M0 or M1 skeletal high-grade osteosarcoma in which case complete surgical resection at all sites was deemed to be possible', '2000 patients in the EURAMOS-1 (European and American Osteosarcoma Study) cohort']","['methotrexate, doxorubicin and cisplatin']","['3-year and 5-year overall survival', 'biopsy, 3-year and 5-year event-free survival', 'histological subtypes telangiectatic', 'survival rates']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",2260.0,0.415819,"The histological subtypes telangiectatic (HR = 0.52, 95% CI: 0.33-0.80) and unspecified conventional (HR = 0.67, 95% CI: 0.52-0.88) were associated with a favourable prognosis compared with chondroblastic subtype.","[{'ForeName': 'Sigbjørn', 'Initials': 'S', 'LastName': 'Smeland', 'Affiliation': 'SSG Oslo University Hospital and Scandinavian Sarcoma Group and Institute for Clinical Medicine, University of Oslo, Norway. Electronic address: ssm@ous-hf.no.'}, {'ForeName': 'Stefan S', 'Initials': 'SS', 'LastName': 'Bielack', 'Affiliation': 'COSS Klinikum Stuttgart - Olgahospital Stuttgart, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': 'EOI University College Hospital, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'COG IWK Health Center, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Pancras', 'Initials': 'P', 'LastName': 'Hogendoorn', 'Affiliation': 'TMG Path Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': ""COG Children's Oncology Group, Arcadia, CA, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gorlick', 'Affiliation': 'COG the University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Janeway', 'Affiliation': 'COG Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Ingleby', 'Affiliation': 'CDC MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Anninga', 'Affiliation': 'EOI, Netherlands.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Antal', 'Affiliation': 'COSS Semmelweis Egyetem Budapest, Budapest, Hungary.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Arndt', 'Affiliation': 'COG Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ken L B', 'Initials': 'KLB', 'LastName': 'Brown', 'Affiliation': 'COG University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Trude', 'Initials': 'T', 'LastName': 'Butterfass-Bahloul', 'Affiliation': 'EISD Centre for Clinical Trials, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Calaminus', 'Affiliation': 'QLCC Pädiatrische Hämatologie und Onkologie, Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': ""EOI Our Lady's Children's Hospital, Dublin, Ireland.""}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Dhooge', 'Affiliation': 'EOI University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'SSG Lund University, Lund, Sweden.'}, {'ForeName': 'Adrienne M', 'Initials': 'AM', 'LastName': 'Flanagan', 'Affiliation': 'EOI Royal National Orthopaedic Hospital, Stanmore; Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Godehard', 'Initials': 'G', 'LastName': 'Friedel', 'Affiliation': 'COSS Klinik Schillerhöhe - Thoraxchirurgie Gerlingen, Germany.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Gebhardt', 'Affiliation': 'COG Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'EOI Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': 'COG UCSF Medical Center-Mission Bay, Pediatric Oncology, San Francisco, CA, USA.'}, {'ForeName': 'Holcombe E', 'Initials': 'HE', 'LastName': 'Grier', 'Affiliation': 'COG Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grimer', 'Affiliation': 'EOI Royal Orthopaedic Hospital, Birmingham, UK.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': 'COG University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hecker-Nolting', 'Affiliation': 'COSS Klinikum Stuttgart - Olgahospital Stuttgart, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Sundby Hall', 'Affiliation': 'SSG Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Isakoff', 'Affiliation': ""COG Connecticut Children's Medical Center, Hartford, CT, USA.""}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Jovic', 'Affiliation': 'CDC MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kühne', 'Affiliation': 'COSS Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Kager', 'Affiliation': 'COSS St. Anna Kinderspital /CCRI, Wien, Austria.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'von Kalle', 'Affiliation': 'COSS Klinikum Stuttgart - Olgahospital Stuttgart, Germany.'}, {'ForeName': 'Edita', 'Initials': 'E', 'LastName': 'Kabickova', 'Affiliation': 'COSS University Hospital MOTOL, Praha, Czech Republic.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'COSS Medizinische Universität Wien, Vienna, Austria.'}, {'ForeName': 'Ching C', 'Initials': 'CC', 'LastName': 'Lau', 'Affiliation': 'COG Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Leavey', 'Affiliation': ""COG Southwestern and Children's Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""COG Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': 'COG Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Mayer-Steinacker', 'Affiliation': 'COSS Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Meyers', 'Affiliation': 'COG Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Nagarajan', 'Affiliation': ""COG Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'COG Primary Childrens Hospital, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'COSS Helios Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Renard', 'Affiliation': 'EOI University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rechnitzer', 'Affiliation': 'SSG Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Schwartz', 'Affiliation': 'COG the University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Strauss', 'Affiliation': 'EOI University College Hospital, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Teot', 'Affiliation': ""COG Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Timmermann', 'Affiliation': 'COSS Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'CDC MRC Clinical Trials Unit at UCL, London, UK. Electronic address: mrcctu.euramos@ucl.ac.uk.'}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'COG Five Prime Therapeutics, Inc South San Francisco, CA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.11.027']
1124,32442205,No effect of repetitive tDCS on daily smoking behaviour in light smokers: A placebo controlled EMA study.,"INTRODUCTION


The effectiveness of repetitive transcranial Direct Current Stimulation (tDCS) on reducing smoking behaviour has been studied with mixed results. Smoking behaviour is influenced by affect and context, therefore we choose to use mobile ecological momentary assessments (EMA) to measure changes in smoking behaviour after tDCS.
METHODS


In a randomized, placebo-controlled, between subject study, we applied tDCS bilaterally with the anodal electrode targeting the right DLPFC (https://clinicaltrials.gov/ct2/show/NCT03027687). Smokers were allocated to six sessions of either active tDCS (n = 35) or sham tDCS (n = 36) and received two sessions on three different days in one week. They were asked to keep track of their daily cigarette consumption, craving and affect in an application on their mobile phones for three months starting one week before the first tDCS session.
RESULTS


Number of smoked cigarettes a day progressively decreased up to one week after the last tDCS session in both conditions. Active treatment had no additional effect on cigarette consumption, craving and affect.
CONCLUSIONS


In this exploratory study, repetitive bilateral tDCS over the DLPFC had no effect on daily smoking behaviour. Future research needs to investigate how motivation to quit smoking and the number of tDCS sessions affect the efficacy of repetitive tDCS.",2020,"Active treatment had no additional effect on cigarette consumption, craving and affect.
",['light smokers'],"['repetitive transcranial Direct Current Stimulation (tDCS', 'sham tDCS', 'active tDCS', 'repetitive tDCS', 'placebo']","['daily smoking behaviour', 'cigarette consumption, craving and affect']","[{'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0277547,"Active treatment had no additional effect on cigarette consumption, craving and affect.
","[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Jongerling', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233414']
1125,32442523,"Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial.","BACKGROUND


The globally synchronised introduction of inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV) were successfully implemented in China's routine immunisation programme in May, 2016. In response to the global shortage of Salk-strain IPV, Sabin-strain IPV production was encouraged to develop and use in low-income and middle-income countries. We assessed the immunogenicity of the current routine poliovirus vaccination schedule in China and compared it with alternative schedules that use Sabin-strain IPV (sIPV) and bOPV.
METHODS


This open-label, randomised, controlled trial recruited healthy infants aged 60-75 days from two centres in Zhejiang, China. Eligible infants were full-term, due for their first polio vaccination, weighed more than 2·5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination. Infants were randomly assigned (1:1:1) using permuted block randomisation (block size of 12) to one of three polio vaccination schedules, with the first, second, and third doses given at ages 2 months, 3 months, and 4 months, respectively: sIPV-bOPV-bOPV (1sIPV+2bOPV group; current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group). The primary endpoint was the proportion of infants with seroconversion to each of the three poliovirus serotypes 1 month after the third dose. Serious and medically important adverse events were monitored for up to 30 days after each vaccination. We assessed immunity in the per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine. This trial is registered with Clinicaltrials.gov, NCT03147560.
RESULTS


Between May 1, 2016, and Dec 1, 2017, we enrolled and randomly assigned 528 eligible infants to one of the three treatment groups (176 in each group); 473 infants (158 in the 1sIPV+2bOPV group, 152 in the 2sIPV+1bOPV group, and 163 in the 3sIPV group) were included in the per-protocol population. 100% seroconversion against poliovirus types 1 and 3 was observed in all three groups. Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001). Seroconversion against type 2 poliovirus was observed in 98 (62%) infants in the 1sIPV+2bOPV group, 145 (95%) infants in the 2sIPV+1bOPV group, and 161 (99%) infants in the 3sIPV group. No serious adverse events occurred during the study; 14 minor, transient adverse events were observed, with no significant differences across study groups.
INTERPRETATION


All three study schedules were well tolerated and highly immunogenic against poliovirus types 1 and 3. Schedules containing two or three sIPV doses had higher seroconversion rates against poliovirus type 2 than did the schedule with a single dose of sIPV. Our findings support inclusion of two sIPV doses in the routine poliovirus vaccination schedule in China to provide better protection against poliovirus type 2 than provided by the current regimen.
FUNDING


Chinese Center for Disease Control and Prevention and China National Biotec Group Company.",2020,Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001).,"['healthy infants aged 60-75 days from two centres in Zhejiang, China', 'per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine', 'Eligible infants were full-term, due for their first polio vaccination, weighed more than 2·5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination', '528 eligible infants to one of the three treatment groups (176 in each group); 473 infants (158 in the 1sIPV+2bOPV group, 152 in the 2sIPV+1bOPV group, and 163 in the 3sIPV group) were included in the per-protocol population', 'Zhejiang, China']","['inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV', 'sIPV-bOPV-bOPV (1sIPV+2bOPV group; current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group', 'Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine']","['Seroconversion against type 2 poliovirus', 'seroconversion rates', 'serious adverse events', 'transient adverse events', 'antibody titres against poliovirus types', 'proportion of infants with seroconversion', 'Immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0419714', 'cui_str': 'First polio vaccination'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0852650', 'cui_str': 'Contraindication to vaccination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",528.0,0.155858,Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001).,"[{'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Chenyan', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Immunisation Programme Department, Hangzhou Municipal Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Immunisation Programme Department, Quzhou Municipal Center for Disease Control and Prevention, Quzhou, Zhejiang, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Immunisation Programme Department, Chun'an County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Zhongbing', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Immunisation Programme Department, Longyou County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Shuyun', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wen', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China. Electronic address: zhpchen@cdc.zj.cn.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: wanghq@chinacdc.cn.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30738-8']
1126,32445670,Long-term safety and efficacy of subcutaneous C1-inhibitor in older patients with hereditary angioedema.,"BACKGROUND


Patients aged 65 years and older with hereditary angioedema (HAE) owing to C1-inhibitor (C1-INH) deficiency may have an altered response to treatment and are at higher risk for treatment-related adverse events (AEs) because of comorbidities and polypharmacy.
OBJECTIVE


To investigate the safety and efficacy of subcutaneous C1 esterase inhibitor (C1-INH) in patients aged 65 years and older treated in an open-label extension of a phase 3 trial.
METHODS


Eligible patients (≥4 attacks for more than 2 consecutive months) were randomized to receive twice-weekly subcutaneous C1-INH with a dosage of 40 IU/kg or 60 IU/kg for 52 to 140 weeks. Safety end points and efficacy outcomes were evaluated for patients aged 65 years and above and younger than 65 years.
RESULTS


Of the 126 patients treated, 10 were 65 years and older (mean age [range], 68 [65-72 years]). A total of 8 of 10 patients had multiple comorbidities, and 6 of these 10 patients were taking more than 5 non-HAE-related drugs concomitantly. AEs occurring in more than 1 patient included injection site bruising (n = 2, related), injection site pain (n = 2, related), urinary tract infection (n = 2, unrelated), and diarrhea (n = 2, unrelated). No thromboembolic events or cases of anaphylaxis were reported. Two patients aged 65 years and older experienced unrelated serious AEs (dehydration and hypokalemia in 1 and pneumonia and an HAE attack leading to hospitalization in another). A total of 6 of 9 evaluable patients were responders, with a greater than or equal to 50% reduction in HAE attacks vs prestudy; 6 of 10 patients had less than 1 attack over 4 weeks and 3 were attack-free (median attack rate, 0.52 attacks per month).
CONCLUSION


Subcutaneous C1-INH was well-tolerated and effective in the management of HAE in patients aged 65 years and older with multiple comorbid conditions and polypharmacy.",2020,No thromboembolic events or cases of anaphylaxis were reported.,"['126 subjects treated', 'Patients ≥65 years old with hereditary angioedema (HAE', 'Eligible patients (≥4 attacks over 2 consecutive months', 'patients ≥65 years old treated in an open-label extension of a phase 3 trial', 'Two subjects ≥65 years old experienced unrelated serious AEs (dehydration and hypokalemia in one and pneumonia and an HAE attack leading to hospitalization in another', 'patients aged ≥65 and <65 years', 'Older Patients With Hereditary Angioedema', 'subjects ≥65 years old with multiple comorbid conditions and polypharmacy', 'Eight of 10 subjects had multiple comorbidities; 6/10 were taking >5 non-HAE-related drugs concomitantly', ' 10 were ≥65 years old (mean age [range], 68 [65-72 years']","['Subcutaneous C1-Inhibitor', 'C1-INH (SC', 'subcutaneous (SC) C1-INH']","['Safety endpoints and efficacy outcomes', 'tolerated and effective', 'urinary tract infection', 'safety and efficacy', 'thromboembolic events', 'HAE attacks']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}]",,0.0321857,No thromboembolic events or cases of anaphylaxis were reported.,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Allergy Section, Division of Immunology, Department of Internal Medicine, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio. Electronic address: jonathan.bernstein@uc.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation and University of Ottawa Medical School, Ottawa, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Baker Allergy, Asthma, and Dermatology Research Center, Portland, Oregon.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Bygum', 'Affiliation': 'Hereditary Angioedema Centre Denmark, Department of Dermatology, and Allergy Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring, King of Prussia, Pennsylvania.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.015']
1127,32449296,Short-term neurophysiological effects of sensory pathway neurorehabilitation strategies on chronic poststroke oropharyngeal dysphagia.,"BACKGROUND


Neurorehabilitation strategies for chronic poststroke (PS) oropharyngeal dysphagia (OD) have been mainly focused on the neurostimulation of the pharyngeal motor cortex with only marginal effects. In contrast, treatments targeting the PS oropharyngeal sensory pathway dysfunction offer very promising results, but there is little knowledge on the underlying mechanisms. We aimed to explore the neurophysiological mechanisms behind the effect of three sensory neurostimulation strategies.
METHODS


We carried out a randomized two-blinded parallel group's crossover sham-controlled clinical trial in 36 patients with unilateral stroke and chronic unsafe swallow to investigate the effect of repetitive transcranial magnetic stimulation (rTMS) of the primary sensory cortex (A), oral capsaicin (B) and intra-pharyngeal electrical stimulation (IPES; C). The effect was evaluated immediately after the interventions with videofluoroscopy (VFS) and motor/sensory evoked potentials (MEP/SEP).
KEY RESULTS


Interventions induced no changes in the biomechanics of the swallow response during VFS. However, an enhancement of motor cortex excitability (latency shortening and increased size of thenar MEP) was found with active interventions (A + B + C, and B/C alone; P < .05 for all) but not with sham. Active but not sham interventions shortened pharyngeal SEP latency in the ipsilesional hemisphere (A + B + C: P2-peak, P = .039; A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
CONCLUSIONS AND INFERENCES


Sensory pathway neurostimulation strategies caused immediate enhancement of motor cortex excitability with peripheral strategies (capsaicin and IPES) and of pharyngeal sensory conduction with rTMS. These changes support the use of sensory neurorehabilitation strategies in promoting swallow recovery in chronic PS-OD.",2020,"A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
","['chronic poststroke (PS) oropharyngeal dysphagia (OD', '36 patients with unilateral stroke and chronic unsafe swallow']","['videofluoroscopy (VFS) and motor/sensory evoked potentials (MEP/SEP', 'sensory pathway neurorehabilitation strategies', 'sensory neurorehabilitation strategies', 'repetitive transcranial magnetic stimulation (rTMS) of the primary sensory cortex (A), oral capsaicin (B) and intra-pharyngeal electrical stimulation (IPES; C']","['motor cortex excitability (latency shortening and increased size of thenar MEP', 'biomechanics of the swallow response', 'chronic poststroke oropharyngeal dysphagia', 'pharyngeal SEP latency']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0230374', 'cui_str': 'Thenar region structure'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}]",36.0,0.0786383,"A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cabib', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Weslania', 'Initials': 'W', 'LastName': 'Nascimento', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Rofes', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Viridiana', 'Initials': 'V', 'LastName': 'Arreola', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Tomsen', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Mundet', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Palomeras', 'Affiliation': 'Neurology Department, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Michou', 'Affiliation': 'Technological Educational Institute Western Greece, Patras, Greece.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Clavé', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ortega', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13887']
1128,32449716,Combining Behavior and EEG to Study the Effects of Mindfulness Meditation on Episodic Memory.,"Although there has been recent interest in how mindfulness meditation can affect episodic memory as well as brain structure and function, no study has examined the behavioral and neural effects of mindfulness meditation on episodic memory. Here we present a protocol that combines mindfulness meditation training, an episodic memory task, and EEG to examine how mindfulness meditation changes behavioral performance and the neural correlates of episodic memory. Subjects in a mindfulness meditation experimental group were compared to a waitlist control group. Subjects in the mindfulness meditation experimental group spent four weeks training and practicing mindfulness meditation. Mindfulness was measured before and after training using the Five Facet Mindfulness Questionnaire (FFMQ). Episodic memory was measured before and after training using a source recognition task. During the retrieval phase of the source recognition task, EEG was recorded. The results showed that mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels increased following mindfulness meditation training. In addition, increases in mindfulness correlated with increases in theta power in right frontal channels. Therefore, results obtained from combining mindfulness meditation training, an episodic memory task, and EEG reveal the behavioral and neural effects of mindfulness meditation on episodic memory.",2020,"The results showed that mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels increased following mindfulness meditation training.",[],"['Mindfulness Meditation', 'mindfulness meditation experimental group spent four weeks training and practicing mindfulness meditation', 'mindfulness meditation training, an episodic memory task, and EEG to examine how mindfulness meditation', 'mindfulness meditation', 'waitlist control group']","['episodic memory', 'Episodic memory', 'Episodic Memory', 'mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]",,0.0109079,"The results showed that mindfulness, source recognition behavioral performance, and EEG theta power in right frontal and left parietal channels increased following mindfulness meditation training.","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nyhus', 'Affiliation': 'Department of Psychology, Bowdoin College; Program in Neuroscience, Bowdoin College; enyhus@bowdoin.edu.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Engel', 'Affiliation': 'Program in Neuroscience, Bowdoin College.'}, {'ForeName': 'Tomas Donatelli', 'Initials': 'TD', 'LastName': 'Pitfield', 'Affiliation': 'Program in Neuroscience, Bowdoin College.'}, {'ForeName': 'Isabella M W', 'Initials': 'IMW', 'LastName': 'Vakkur', 'Affiliation': 'Program in Neuroscience, Bowdoin College.'}]",Journal of visualized experiments : JoVE,['10.3791/61247']
1129,32446674,Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey.,"STUDY OBJECTIVE


It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.
METHODS


A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ 2 , and Fisher's exact tests were conducted.
RESULTS


Of 317 patients and surrogates, 90% agreed with or were neutral about the statement ""I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,"" whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.
CONCLUSION


This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.",2020,"General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants.","['participants at all sites in a large, multicenter exception from informed consent trial', 'Twenty-seven percent disagreed with enrollment in the study without prospective consent', '317 patients and surrogates, 90% agreed with or were neutral about the statement ""I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,"" whereas 10% disagreed', 'Black participants', 'pediatric and adult patients']",['benzodiazepine-refractory status epilepticus'],"['attitudes toward trial enrollment, exception from informed consent, and community consultation']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",317.0,0.0303521,"General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants.","[{'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Scicluna', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI. Electronic address: vmah@med.umich.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Biros', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Deneil K', 'Initials': 'DK', 'LastName': 'Harney', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Jones', 'Affiliation': 'University of Texas Health Sciences Center at Houston, Houston, TX.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Mitchell', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rebecca D', 'Initials': 'RD', 'LastName': 'Pentz', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA; Winship Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'Speight', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Neal W', 'Initials': 'NW', 'LastName': 'Dickert', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA; Emory University Rollins School of Public Health, Atlanta, GA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.03.017']
1130,32452814,The Personal Health Network Mobile App for Chemotherapy Care Coordination: Qualitative Evaluation of a Randomized Clinical Trial.,"BACKGROUND


Cancer care coordination addresses the fragmented and inefficient care of individuals with complex care needs. The complexity of care coordination can be aided by innovative technology. Few examples of information technology-enabled care coordination exist beyond the conventional telephone follow-up. For this study, we implemented a custom-designed app, the Personal Health Network (PHN)-a Health Insurance Portability and Accountability Act-compliant social network built around a patient to enable patient-centered health and health care activities in collaboration with clinicians, care team members, caregivers, and others designated by the patient. The app facilitates a care coordination intervention for patients undergoing chemotherapy.
OBJECTIVE


This study aimed to understand patient experiences with PHN technology and assess their perspectives on the usability and usefulness of PHNs with care coordination during chemotherapy.
METHODS


A two-arm randomized clinical trial was conducted to compare the PHN and care coordination with care coordination alone over a 6-month period beginning with the initiation of chemotherapy. A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting. All participants in the intervention arm were interviewed on completion of the study. Interviews were recorded and transcribed verbatim. A summative thematic analysis was completed for the transcribed interviews. Features of the app were also evaluated.
RESULTS


A total of 27 interviews were completed. The resulting themes included the care coordinator as a partner in care, learning while sick, comparison of other technology to make sense of the PHN, communication, learning, usability, and usefulness. Users expressed that the nurse care coordinators were beneficial to them because they helped them stay connected to the care team and answered their questions. They shared that the mobile app gave them access to the health information they were seeking. Users expressed that the mobile app would be more useful if it was fully integrated with the electronic health record.
CONCLUSIONS


The findings highlight the value of care coordination from the perspectives of cancer patients undergoing chemotherapy and the important role of technology, such as the PHN, in enhancing this process by facilitating better communication and access to information regarding their illness.",2020,"A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting.","['cancer patients undergoing', 'patients undergoing chemotherapy']","['chemotherapy', 'care coordination intervention']",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],27.0,0.0497466,"A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ngo', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Cynthia G', 'Initials': 'CG', 'LastName': 'Matsumoto', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Joseph', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Bell', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bold', 'Affiliation': 'Comprehensive Cancer Center, University of California Davis Health, Sacramento, CA, United States.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Washington State University College of Nursing - Vancouver, Vancouver, WA, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Reed', 'Affiliation': 'Division of Social Work, California State University Sacramento, Sacramento, CA, United States.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Kim', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/16527']
1131,32452817,A Questionnaire for Assessing User Satisfaction With Mobile Health Apps: Development Using Rasch Measurement Theory.,"BACKGROUND


Mobile health (mHealth) apps offer great opportunities to deliver large-scale, cost-efficient digital solutions for implementing lifestyle changes. Furthermore, many mHealth apps act as medical devices. Yet, there is little research on how to assess user satisfaction with an mHealth solution.
OBJECTIVE


This study presents the development of the mHealth Satisfaction Questionnaire and evaluates its measurement properties.
METHODS


Respondents who took part in the Health Integrator Study and were randomized to use the Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching, rated their satisfaction with the app using the new 14-item mHealth Satisfaction Questionnaire. The ratings were given on a 5-point Likert scale and measurement properties were evaluated using Rasch measurement theory (RMT).
RESULTS


Optimal scoring was reached when response options 2, 3, and 4 were collapsed, giving three response categories. After omitting two items that did not fit into the scale, fit residuals were within, or close to, the recommended range of ±2.5. There was no differential item functioning between intervention group, age group, or sex. The Person Separation Index was 0.79, indicating that the scale's ability to discriminate correctly between person leniency was acceptable for group comparisons but not for individual evaluations. The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96. In addition, several items showed local dependency and three underlying dimensions emerged: negative experiences, positive experiences, and lifestyle consequences of using the mHealth solution.
CONCLUSIONS


In times where mHealth apps and digital solutions are given more attention, the mHealth Satisfaction Questionnaire provides a new possibility to measure user satisfaction to ensure usability and improve development of new apps. Our study is one of only a few cases where RMT has been used to evaluate the usability of such an instrument. There is, though, a need for further development of the mHealth Satisfaction Questionnaire, including the addition of more items and consideration of further response options. The mHealth Satisfaction Questionnaire should also be evaluated in a larger sample and with other mHealth apps and in other contexts.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03579342; http://clinicaltrials.gov/ct2/show/NCT03579342.",2020,The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96.,"['Respondents who took part in the Health Integrator Study', 'Mobile Health Apps']","['Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching']",['Person Separation Index'],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0311165,The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Melin', 'Affiliation': 'Research Institutes of Sweden AB, Göteborg, Sweden.'}, {'ForeName': 'Stephanie Erika', 'Initials': 'SE', 'LastName': 'Bonn', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Pendrill', 'Affiliation': 'Research Institutes of Sweden AB, Göteborg, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/15909']
1132,32452818,Assessment of the Efficacy of a Mobile Phone-Delivered Just-in-Time Planning Intervention to Reduce Alcohol Use in Adolescents: Randomized Controlled Crossover Trial.,"BACKGROUND


Interventions to reduce alcohol use typically include several elements, such as information on the risks of alcohol consumption, planning for sensible drinking, and training of protective behavioral strategies. However, the effectiveness of these individual intervention elements within comprehensive programs has not been addressed so far, but it could provide valuable insights for the development of future interventions. Just-in-time interventions provided via mobile devices are intended to help people make healthy decisions in the moment and thus could influence health behavior.
OBJECTIVE


The aim of this study was to test the proximal effects of a mobile phone-delivered, just-in-time planning intervention to reduce alcohol use in adolescents who reported recent binge drinking. The efficacy of this individual intervention element was tested within a comprehensive intervention program to reduce problem drinking in adolescents.
METHODS


The study had an AB/BA crossover design, in which participants were randomly allocated to (1) a group receiving the planning intervention (A) in period 1 and assessment only (B) in period 2 or (2) a group receiving assessment only (B) in period 1 and the planning intervention (A) in period 2. The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan. There was a washout period of at least 1 week between period 1 and period 2.
RESULTS


Out of 633 program participants who recently binge drank, 136 (21.5%) were receptive in both periods of time and provided data on the proximal outcome, which was the number of alcoholic drinks consumed with friends or when going out. After the planning intervention, the number of alcoholic drinks consumed was approximately one standard drink lower compared with the finding without the intervention (P=.01).
CONCLUSIONS


A mobile phone-delivered, just-in-time, if-then planning intervention to practice sensible drinking with friends or when going out is effective in reducing alcohol consumption among adolescents who report recent binge drinking. Based on the relatively low percentage of participants with self-reported receptivity for the planning intervention, measures to increase the population impact of similar planning interventions should be implemented and tested in future trials.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN52150713; http://www.isrctn.com/ISRCTN52150713.",2020,The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan.,"['Adolescents', 'Out of 633 program participants who recently binge drank, 136 (21.5', 'adolescents who report recent binge drinking', 'adolescents who reported recent binge drinking', 'adolescents']","['mobile phone-delivered, just-in-time planning intervention', 'Mobile Phone-Delivered Just-in-Time Planning Intervention', 'planning intervention (A) in period 1 and assessment only (B) in period 2 or (2) a group receiving assessment only (B) in period 1 and the planning intervention']",['number of alcoholic drinks'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]",633.0,0.048824,The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan.,"[{'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Paz Castro', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'Applied Social and Health Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Center for Digital Health Interventions, Institute of Technology Management, University of St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Michael Patrick', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Radtke', 'Affiliation': 'Health, Work & Organizational Psychology, School of Psychology and Psychotherapy, Witten/Herdecke University, Witten/Herdecke, Germany.'}]",JMIR mHealth and uHealth,['10.2196/16937']
1133,32453168,Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial.,"BACKGROUND


Ultrasound has increased the efficacy of femoral nerve catheters but their postoperative dislocation still remains a common problem. Although catheter placement parallel to the nerve seems to reduce dislocation rates in other nerves and plexuses, the possible advantage for femoral nerve catheter placement remains unclear.
OBJECTIVE


To compare the dislocation rates of femoral catheters when placed perpendicular or parallel to the femoral nerve.
DESIGN


Randomised controlled study.
SETTING


University orthopaedic hospital. Duration of study: October 2018 to June 2019.
PATIENTS


Eighty patients scheduled for major knee surgery with femoral catheter were enrolled and randomly allocated in two groups. Data from 78 patients could be analysed.
INTERVENTIONS


The femoral nerve catheters was placed perpendicular to the nerve in Group 1 (n=40), whereas in Group 2 (n=38) parallel to it. For Group 1 the short-axis view of the nerve and an in-plane puncture was used. For Group 2 we used the short-axis view of the nerve and an out-of-plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane.
MAIN OUTCOME MEASURES


Primary outcome was the catheter dislocation rate in the first 48 h. Secondary outcomes were pain scores and sensory blockade.
RESULTS


There was no statistically significant difference between the two techniques regarding dislocation of the catheters at 24 or 48 h (at 48 h, Group 1: 15%, Group 2: 2.6%, P = 0.109). Also pain scores, sensory blockade and rescue doses of ropivacaine did not differ between the groups. However, in Group 2 the technique took longer.
CONCLUSION


Rotating the ultrasound probe to the long-axis in-plane view enabled examination of the catheter position when it was placed parallel to the nerve. The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03693755.",2020,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
","['University orthopaedic hospital', '78 patients could be analysed', 'Eighty patients scheduled for major knee surgery with femoral catheter', 'Duration of study: October 2018 to June 2019']","['perineural catheters placed either perpendicular or parallel to the femoral nerve', 'ropivacaine', 'plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane']","['Dislocation rates', 'dislocation of the catheters', 'pain scores and sensory blockade', 'catheter dislocation rate', 'dislocation rates', 'pain scores, sensory blockade and rescue doses', 'dislocation rate, pain scores or sensory blockade', 'dislocation rates of femoral catheters']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",80.0,0.154648,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade.
","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kalimeris', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rupnik', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Allenspach', 'Affiliation': ''}, {'ForeName': 'Sandro F', 'Initials': 'SF', 'LastName': 'Fucentese', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Götschi', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Aguirre', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Eichenberger', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001237']
1134,31410765,Effect of Lozenges Containing Lactobacillus reuteri on the Severity of Recurrent Aphthous Ulcers: a Pilot Study.,"To investigate the effect of a probiotic supplement on the severity of aphthous lesions in patients with recurrent aphthous stomatitis (RAS) over a 3-month period. A second endpoint was to study the effect on pain related to the lesions. The study employed a double-blind randomized, placebo-controlled design with two parallel arms. Twenty patients with minor and major RAS were consecutively enrolled and randomly assigned to the test or the control group. The intervention consisted of lozenges containing two strains of Lactobacillus reuteri taken twice daily for 90 days. Ulcer Severity Score (USS) consisting of six lesion characteristics (number, size, duration, ulcer-free period, site, and pain) was calculated at baseline and after the intervention. Oral pain related to the lesions was estimated by the patients with a Visual Analogue Pain Scale. An improvement of the USS, as well as oral pain, was evident in both groups after 90 days but the reduction was only statistically significant (p < 0.05) compared with baseline in the test group. There were no significant differences between the groups, neither at baseline nor at follow-up. No side effects were recorded. Daily supplements with L. reuteri reduced the severity of aphthous lesions over a 90-day period but the improvement was not significantly better than placebo. The results encourage further research and provide a basis for power calculations of larger and extended studies. ClinicalTrials.gov Identifier: NCT02976922.",2020,Daily supplements with L. reuteri reduced the severity of aphthous lesions over a 90-day period but the improvement was not significantly better than placebo.,"['patients with recurrent aphthous stomatitis (RAS', 'Twenty patients with minor and major RAS']","['lozenges containing two strains of Lactobacillus reuteri', 'placebo', 'probiotic supplement', 'Lozenges Containing Lactobacillus reuteri']","['Oral pain', 'severity of aphthous lesions', 'pain', 'oral pain', 'Severity of Recurrent Aphthous Ulcers', 'Ulcer Severity Score (USS) consisting of six lesion characteristics (number, size, duration, ulcer-free period, site, and pain', 'Visual Analogue Pain Scale', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937365', 'cui_str': 'Recurrent aphthous ulcer (disorder)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0221776', 'cui_str': 'Painful mouth (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2937365', 'cui_str': 'Recurrent aphthous ulcer (disorder)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0855241,Daily supplements with L. reuteri reduced the severity of aphthous lesions over a 90-day period but the improvement was not significantly better than placebo.,"[{'ForeName': 'Anne Marie Lynge', 'Initials': 'AML', 'LastName': 'Pedersen', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark. amlp@sund.ku.dk.'}, {'ForeName': 'Kathrine Hansen', 'Initials': 'KH', 'LastName': 'Bukkehave', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'Eric Paul', 'Initials': 'EP', 'LastName': 'Bennett', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Twetman', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-019-09586-x']
1135,32493780,Accuracy of Xpert Ultra in Diagnosis of Pulmonary Tuberculosis among Children in Uganda: a Substudy from the SHINE Trial.,"Childhood tuberculosis (TB) presents significant diagnostic challenges associated with paucibacillary disease and requires a more sensitive test. We evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Ultra) compared to other microbiological tests using respiratory samples from Ugandan children in the SHINE trial. SHINE is a randomized trial evaluating shorter treatment in 1,204 children with minimal TB disease in Africa and India. Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with the Xpert MTB/RIF assay (Xpert) and with Lowenstein-Jensen medium (LJ) and liquid mycobacterial growth indicator tube (MGIT) cultures. We selected only uncontaminated stored sample pellets for Ultra testing. We estimated the sensitivity of Xpert and Ultra against culture and a composite microbiological reference standard (any positive result). Of 398 children, 353 (89%) had culture, Xpert, and Ultra results. The median age was 2.8 years (interquartile range [IQR], 1.3 to 5.3); 8.5% (30/353) were HIV infected, and 54.4% (192/353) were male. Of the 353, 31 (9%) were positive by LJ and/or MGIT culture, 36 (10%) by Ultra, and 16 (5%) by Xpert. Sensitivities (95% confidence intervals [CI]) were 58% (39 to 65% [18/31]) for Ultra and 45% (27 to 64% [14/31]) for Xpert against any culture-positive result, with false positives of <1% and 5.5% for Xpert and Ultra. Against a composite microbiological reference, sensitivities were 72% (58 to 84% [36/50]) for Ultra and 32% (20 to 47% [16/50]) for Xpert. However, there were 17 samples that were positive only with Ultra (majority trace). Among children screened for minimal TB in Uganda, Ultra has higher sensitivity than Xpert. This represents an important advance for a condition which has posed a diagnostic challenge for decades.",2020,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","['Ugandan children in the SHINE trial', '1204 children with minimal TB disease in Africa/India', '398 children, 353 (89%) had culture, Xpert and Ultra results', 'Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with', 'Median age was 2.8-years (IQR 1.3-5.3); 8.5% (30/353) HIV-infected, 54.4% (192/353) male', 'pulmonary tuberculosis among children in Uganda']","['Xpert MTB/Rif (Xpert), Lowenstein Jensen (LJ) and liquid (MGIT) cultures', 'XpertMTB/Rif Ultra (Ultra', 'Xpert Ultra']",['Sensitivities'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C1280568', 'cui_str': 'Specimen obtained by fine needle aspiration procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",1204.0,0.137987,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","[{'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Ssengooba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda Willyssengooba@gmail.com.'}, {'ForeName': 'Jean de Dieu', 'Initials': 'JD', 'LastName': 'Iragena', 'Affiliation': 'Communicable Diseases Cluster, HIV/TB and Hepatitis Programme, World Health Organization Regional Office for Africa, Brazzaville, Congo.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Nakiyingi', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Serestine', 'Initials': 'S', 'LastName': 'Mujumbi', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wobudeya', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mboizi', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulware', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Choo', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lebeau', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Joloba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Demers', 'Affiliation': 'Desmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Fiona V', 'Initials': 'FV', 'LastName': 'Cresswell', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}]",Journal of clinical microbiology,['10.1128/JCM.00410-20']
1136,32493872,Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement.,"OBJECTIVE


To evaluate the effect of music therapy on the chronic pain and midterm quality of life of patients after mechanical valve replacement.
METHODS


Patients were divided into two groups according to whether or not they received music therapy. The patients in the music group received 30 minutes of music therapy every day for 6 months after the operation. The patients in the control group received standard treatment and had 30 minutes of quiet rest time every day in the same period. The short-form of McGill Pain Questionnaire (SF-MPQ) was used to evaluate the degree of postoperative chronic pain, and the SF-36 was used to evaluate the midterm quality of life of patients.
RESULTS


In terms of the degree of postoperative chronic pain, the score of the pain rating index (PRI) emotional item in the music group was significantly lower than that in the control group. In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
CONCLUSION


This study preliminarily showed that music therapy can effectively reduce chronic pain and improve midterm quality of life after surgery.",2020,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","['Patients after Mechanical Valve Replacement', 'Patients', 'patients after mechanical valve replacement']","['music therapy', 'standard treatment and had 30 minutes of quiet rest time', 'Music Therapy']","['chronic pain', 'emotional function score', 'chronic pain and midterm quality of life', 'postoperative chronic pain, the score of the pain rating index (PRI) emotional item', 'midterm quality of life', 'Chronic Pain and Midterm Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0493251,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","[{'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.20-00022']
1137,32502306,Motivational processes during physical endurance tasks.,"PURPOSE


Motivational processes are insufficiently recognized in models of human endurance. Hence, two studies examined a motivational model proposing that the quality of pre-task autonomous motivation influences performance at high intensity via the in-task temptation to reduce effort and value of goal pursuit.
METHODS


The studies involved 40 participants each (Study 1:33% female, M age   = 21.55, SD = 1.97; Study 2:45% female, M age   = 22.65, SD = 2.61) completing measures of autonomous motivation prior to a 10-minute cycling task. Measures of the temptation to reduce effort and value of goal pursuit were taken every minute during the trial (Study 1) or near the midpoint of the trial (Study 2). Data were analyzed using multilevel growth and parallel mediation models.
RESULTS


In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance. Study 1 revealed nuances within these relationships depending on whether task initiation or change over time was considered. In Study 2, indirect effects of autonomous motivation on performance via temptation to reduce effort (b = 0.20, 95% CIs 0.03-0.50) and goal value (b = 0.26, 95% CIs 0.01-0.44) were evidenced.
CONCLUSION


Two studies supported a theoretically viable model explaining the dynamics between pre-task and in-task motivation underpinning performance at high intensities.",2020,"In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance.","['40 participants each (Study 1: 33% female, M age  = 21.55, SD = 1.97; Study 2: 45% female, M age  = 22.65, SD = 2.61) completing measures of autonomous motivation prior to a ten-minute cycling task']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}]",[],[],40.0,0.0755075,"In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance.","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Taylor', 'Affiliation': 'School of Sport, Exercise & Health Sciences, Loughborough University, Leicestershire, UK.'}, {'ForeName': 'Kieren', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'One-Eighty Psychology Behaviour Support, Oxford, UK.'}, {'ForeName': 'Raymon', 'Initials': 'R', 'LastName': 'Hunte', 'Affiliation': 'Nottingham Trent University, Nottingham, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13739']
1138,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND


Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes.
OBJECTIVES


We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL).
METHODS


46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS.
RESULTS


There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion.
CONCLUSIONS


Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015']
1139,32512234,Oxygen supplementation increases the total work and muscle damage markers but reduces the inflammatory response in COPD patients.,"INTRODUCTION


Oxygen supplementation (O 2 -Suppl) is recommended for pulmonary rehabilitation with higher exercise intensities. However, high-intensity exercise tends toward muscle damage and a greater inflammatory response. We aimed to investigate the effect of O 2 -Suppl during exercise test (EET) on CRP level and muscle damage (CPK, LDH, lactate) in non-hypoxemic COPD patients.
METHODS


Eleven non-depleted patients with COPD (FEV 1  65.5 ± 4.3 %) performed two EET (room-air or O 2 -Suppl-100 %), through a blind, randomized, and placebo-controlled crossover design. CPK, LDH and CRP were measured before, immediately after and 24 h after EET.
RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3 %; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L). The O 2 -Suppl protocol resulted in a lower increase in CRP (92.1 ± 112.4 % vs. 400.1 ± 384.9 %; p = 0.003).
CONCLUSIONS


O 2 -Suppl increases exercise-tolerance, resulting in increased muscle injury markers in COPD. However, oxygen supplementation attenuates the inflammatory response, even upon increased physical exercise.",2020,"RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","['Eleven non-depleted patients with COPD (FEV 1  65.5\u2009±\u20094.3%) performed two EET (room-air or O 2 -Suppl-100', 'COPD patients', 'non-hypoxemic COPD patients']","['oxygen supplementation', 'Oxygen supplementation (O 2 -Suppl', 'O 2 -Suppl during exercise test (EET', 'Oxygen supplementation', 'placebo']","['Exercise time', 'CRP', 'CPK and LDH', 'CPK, LDH and CRP', 'total work and muscle damage markers', 'physical exercise', 'exercise-tolerance', 'CRP level and muscle damage (CPK, LDH, lactate', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",11.0,0.185322,"RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","[{'ForeName': 'Daniela Rodrigues', 'Initials': 'DR', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Kelly Critine', 'Initials': 'KC', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Julia Sampel', 'Initials': 'JS', 'LastName': 'de Castro', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Viviani Aparecida', 'Initials': 'VA', 'LastName': 'Lara', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'de Luca', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil.'}, {'ForeName': 'Mayron F', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; VO2Care Research Group, Research Physiotherapy Coordinator of Vila Nova Star Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Wladimir Musetti', 'Initials': 'WM', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil; Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil; Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; HEART - Institute of Cardiology, Department of Education and Research, São Paulo, Brazil. Electronic address: wmusettimedeiros@hotmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103475']
1140,32513518,Combinatorial Pharmacogenomic Testing Improves Outcomes for Older Adults With Depression.,"OBJECTIVE


Evaluate the clinical utility of combinatorial pharmacogenomic testing for informing medication selection among older adults who have experienced antidepressant medication failure for major depressive disorder (MDD).
DESIGN


Post hoc analysis of data from a blinded, randomized controlled trial comparing two active treatment arms.
SETTING


Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites.
PARTICIPANTS


Adults age 65 years or older at baseline (n = 206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode.
INTERVENTION


Combinatorial pharmacogenomic testing to inform medication selection (guided-care), compared with treatment as usual (TAU).
OUTCOMES


Mean percent symptom improvement, response rate, and remission rateat week 8, measured using the 17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis.
RESULTS


At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU. By week 8, more than twice as many patients in guided-care than in TAU were on medications predicted to have no gene-drug interactions (χ 2  = 19.3, df = 2; p <0.001). Outcomes in the guided-care arm showed consistent improvement through the end of the open-design 24-week trial, indicating durability of the effect. Differences in outcomes between arms were not significantly impacted by comorbidities.
CONCLUSIONS


Combinatorial pharmacogenomic test-informed medication selection improved outcomes over TAU among older adults with depression.",2020,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","['older adults with depression', 'older adults who have experienced antidepressant medication failure for major depressive disorder (MDD', 'Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites', 'Older Adults With Depression', 'Adults age 65 years or older at baseline (n\u202f=\u202f206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode']","['combinatorial pharmacogenomic testing', 'Combinatorial PharmacogenomicTesting']","['Mean percent symptom improvement, response rate, and remission rateat', 'symptom improvement', '17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis', 'remission']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0861888,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","[{'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA. Electronic address: bforester@mclean.harvard.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weisenbach', 'Affiliation': 'Stony Brook University, Department of Psychiatry & Behavioral Health (SW), Stony Brook, NY.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Ajilore', 'Affiliation': 'University of Illinois at Chicago, School of Public Health/Psychiatric Institute (OJ), Chicago, IL.'}, {'ForeName': 'Ipsit', 'Initials': 'I', 'LastName': 'Vahia', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Healthcare (AJR), Worcester, MA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, the Corporal Michael Crescenz VAMC (MET), Philadelphia, PA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences (BWD), Atlanta, GA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences (CDB), Stanford, CA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Washington University School of Medicine, Department of Psychiatry, and the John Cochran Veteran's Administration Hospital (CRC), St. Louis, MO.""}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychiatry and School of Medicine (RCS), Birmingham, AL.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Psychiatry and Behavioral Sciences (MM), Wichita, KS.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Traxler', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dechairo', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.005']
1141,32516483,Cycling-specific isometric resistance training improves peak power output in elite sprint cyclists.,"INTRODUCTION


This study aimed to assess the efficacy of a 6-week cycling-specific, isometric resistance training program on peak power output (PPO) in elite cyclists.
METHODS


Twenty-four elite track sprint cyclists were allocated to EXP (n = 13, PPO, 1537 ± 307 W) and CON (n = 11, PPO, 1541 ± 389 W) groups. All participants completed a 6-week training program; training content was identical except participants in the EXP group replaced their usual compound lower body resistance training exercise with a cycling-specific, isometric resistance training stimulus. Cycling PPO, knee extensor and cycling-specific isometric strength, and measures of muscle architecture were assessed pre- and post-training.
RESULTS


In EXP, absolute and relative PPO increased (46 ± 62 W and 0.8 ± 0.7 W/kg, P < .05), and the change in relative PPO was different to CON (-0.1 ± 1.0 W/kg, group × time interaction P = .02). The increase in PPO was concurrent with an increase in extrapolated maximal torque in EXP (7.1 ± 6.5 Nm, P = .007), but the effect was not different from the change in CON (2.4 ± 9.7 Nm, group × time P = .14). Cycling-specific isometric strength also increased more in EXP (group × time P = .002). There were no other between-group differences in response to training.
CONCLUSION


A 6-week novel, cycling-specific isometric resistance training period improved PPO in a group of elite sprint cyclists by 3%-4%. These data support the use of a cycling-specific isometric resistance training stimulus in the preparation programs of world-class cyclists.",2020,Cycling-specific isometric strength also increased more in EXP (group × time p = 0.002).,"['elite cyclists', 'world-class cyclists', 'elite\xa0sprint cyclists', 'Twenty-four elite track sprint cyclists']","['EXP group replaced their usual compound lower body resistance training exercise with a cycling-specific, isometric resistance training stimulus', 'Cycling-specific isometric resistance training', 'EXP', 'CON', 'six-week cycling-specific, isometric resistance training programme']","['Cycling-specific isometric strength', 'change in relative PPO', 'PPO', 'absolute and relative PPO', 'peak power output (PPO', 'Cycling PPO, knee extensor and cycling-specific isometric strength, and measures of muscle architecture', 'extrapolated maximal torque']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",,0.0195751,Cycling-specific isometric strength also increased more in EXP (group × time p = 0.002).,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Kordi', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Folland', 'Affiliation': 'School of Sport, Exercise & Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Menzies', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Tejal Sarika', 'Initials': 'TS', 'LastName': 'Patel', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The Football Association, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13742']
1142,32524612,Impact of Labeled Glasses in a Bar Laboratory Setting: No Effect on Ad Libitum Alcohol Consumption.,"AIMS


Information provided on glass labels may be an effective method to reduce alcohol consumption. The aim of this study was to assess the impact of glass labels conveying unit information and a health warning in reducing ad libitum alcohol consumption.
METHODS


A cluster-randomized experimental study was conducted to measure the efficacy of a labeled glass in reducing alcohol consumption in a semi naturalistic bar laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers. Pairs were randomized to receive two 340-ml glasses of beer or wine: labeled or plain (control). Alcohol consumption was assessed in an ad libitum drinking period, and urge to drink was measured at baseline and postdrinking period. Focus groups (n = 2) were conducted, and thematic analysis was used to gain an insight into the acceptability and the perceived effectiveness of the glasses.
RESULTS


Mean unit consumption was 1.62 (SD ± 0.83) units in the labeled glass condition and 1.69 (SD ± 0.82) units in the non labeled glass condition. There were no significant effects of the labeled glasses on ad libitum alcohol consumption (95% CI -0.25 to 0.37, p = 0.35), despite participants (85%) noticing the information. Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behavior due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts.
CONCLUSIONS


Labeled glasses did not change alcohol consumption in the current study, potentially due to ineffectiveness of this type of message in a young adult population. The information on the glasses was attended to, highlighting that glasses could be a feasible tool for providing information.",2020,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts.
","['a semi-naturalistic bar-laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers']","['labelled glass', '340 ml glasses of beer or wine: labelled or plain (control', 'labelled glasses']","['alcohol consumption', 'Mean unit consumption', 'labelled glasses on ad libitum alcohol consumption', 'Alcohol consumption']","[{'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",2.0,0.0811205,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts.
","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'University of Cambridge Institute of Public Health, (NC), Cambridge, UK.'}, {'ForeName': 'Abigail K', 'Initials': 'AK', 'LastName': 'Rose', 'Affiliation': 'Department of Psychological Sciences, (NC, AKR), University of Liverpool, Liverpool, UK.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14392']
1143,32526534,The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.
METHODS


RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.
DISCUSSION


This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.
TRIAL REGISTRATION


Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001']
1144,32683215,Intensive upper extremity training improved whole body movement control for children with unilateral spastic cerebral palsy.,"BACKGROUND


Children with unilateral spastic cerebral palsy (USCP) exhibit impaired bimanual coordination, gait control, and whole body movement control. Intensive upper extremity training has been found to be effective for improving upper extremity function. However, the effectiveness of the intensive upper extremity training on whole body movement control is not known.
RESEARCH QUESTION


The present study aimed to evaluate the effects of Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT) on bimanual coordination and gait control during a complex whole body task.
METHODS


Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS: I-II, MACS: I-II) were randomly assigned to either CIMT or HABIT for 6 h per day training for 15 days. Children were asked to perform two whole body tasks (walking with and without a tray carrying) while 3-D kinematic analysis was performed before and after training.
RESULTS


After training, the HABIT group increased the symmetry in height of their hands during tray carrying (more leveled tray). Both CIMT and HABIT groups decreased the lateral motion of the tray. The CIMT group increased speed and stride length after training in both the walking and tray carrying tasks. Both groups also increased their minimum toe clearance (all p < 0.05).
SIGNIFICANCE


Two types of intensive upper extremity training have provided significant improvements to whole body movement control for children with USCP. Adhering to the specificity of practice concept, HABIT improved bimanual coordination after training during the whole body tray carrying tasks. Given extensive interactions between the upper and lower extremities in real-world activities, future studies should focus on the effects of such combined training.",2020,"Both groups also increased their minimum toe clearance (all p < 0.05).
","['children with unilateral spastic cerebral palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', 'Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS']","['CIMT or HABIT', 'Intensive upper extremity training improved whole body movement control', 'CIMT', 'Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT', 'intensive upper extremity training', 'Intensive upper extremity training']","['bimanual coordination and gait control', 'symmetry in height of their hands', 'speed and stride length', 'lateral motion of the tray', 'minimum toe clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",16.0,0.0108967,"Both groups also increased their minimum toe clearance (all p < 0.05).
","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA. Electronic address: yaching.hung@qc.cuny.edu.'}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Shirzad', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Box 199, NY 10027, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.009']
1145,32683383,Efficacy of ozonized water for the treatment of erosive oral lichen planus: a randomized controlled study.,"BACKGROUND


Management of erosive Oral Lichen Planus (eOLP) is challenging. Currently, topical corticosteroids are widely used as first-line therapy, but they might be associated with side-effects and incomplete clinical response. Among non-pharmacological strategies, ozone at low medical concentration has proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases. The aim of this randomized controlled study was to investigate the effectiveness of ozonized water in association with conventional topical corticosteroids for the treatment of eOLP.
MATERIAL AND METHODS


Fifty-one patients were included in the study and randomized into 2 groups: study group (n=26) included patients receiving ozonized water treatment; control group (n=25) included patients receiving placebo treatment (i.e. double-distilled water). Treatment protocol consisted of 1-minute oral rinses, repeated for 4 times, twice a week for 4 weeks. All patients received conventional corticosteroid topical therapy (betamethasone soluble tablets, 2 rinses/day for 4 weeks). Assessment of size of lesions, sign and pain scores was performed before treatment, after 2 weeks of treatment (T1) and at the end of 4-week treatment (T2). Efficacy Index (EI) of treatment, candidiasis and relapse rates were also recorded.
RESULTS


All patients experienced significant improvement of sign and pain scores with a higher rate of improvement in ozone-treated group (T1 improvement rates: Thongprasom 92.2% vs 28%; VAS pain 76.9% vs 32%; p<0.05). Pain and size reduction were significantly higher in ozone-treated group both at T1 and T2 (p<0.05). Ozone-treated group showed a higher EI at every time point (T0-T2: 72.77% vs 37.66%, p<0.01). Candidiasis (32% vs 11.5%) and relapse (40% vs 34.6%) rates were higher in control group, however the differences were not statistically significant.
CONCLUSIONS


Within the limitations of this study, ozonized water seems to be effective as an adjunct therapy, in combination with topical corticosteroids, for the treatment of eOLP.",2020,Pain and size reduction were significantly higher in ozone-treated group both at T1 and T2 (p<0.05).,"['Fifty-one patients were included in the study and randomized into 2 groups: study group (n=26) included patients receiving', 'erosive oral lichen planus', 'erosive Oral Lichen Planus']","['conventional corticosteroid topical therapy (betamethasone soluble tablets', 'ozonized water treatment; control group', 'placebo treatment (i.e. double-distilled water', 'ozonized water']","['size of lesions, sign and pain scores', 'Candidiasis', 'sign and pain scores', 'Efficacy Index (EI) of treatment, candidiasis and relapse rates', 'relapse', 'Pain and size reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0406378', 'cui_str': 'Erosive oral lichen planus'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",51.0,0.0461569,Pain and size reduction were significantly higher in ozone-treated group both at T1 and T2 (p<0.05).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Veneri', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bardellini', 'Affiliation': 'Dental Clinic, p.le Spedali Civili n.1 25133 Brescia elena.bardellini@unibs.it.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Majorana', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23693']
1146,32552446,Online couples mindfulness-based intervention for young breast cancer survivors and their partners: A randomized-control trial.,"PURPOSE


Young breast cancer survivors (YBCS) face unique challenges in coping with disease, distress, and relationship concerns. The purposes of this study were to understand the acceptability and feasibility of an online Mindfulness-Based Intervention (MBI) for YBCS and their partners (i.e., Couples Mindfulness-Based Intervention: C-MBI) and to compare the effectiveness of the C-MBI to a closely-matched control, an online MBI for individuals (I-MBI).
METHODS


YBCS and their partners were recruited. Couples were randomly assigned to an 8-week C-MBI (couples = 41) or to I-MBI (couples = 36), which included one-hour video modules, a manual, and guided-meditation audios. Both couple members participated in the C-MBI; only the YBCS participated in the control I-MBI. Participants answered surveys about individual- and couple-level functioning at baseline and post-intervention.
RESULTS


Online delivery was shown to be feasible and acceptable. For YBCS and their partners, levels of perceived stress, anxiety, depression, and fatigue were lower after the intervention, in both conditions. Unexpectedly, however, participating in the C-MBI appeared to have detrimental effects on dyadic adjustment and relationship quality.
CONCLUSION


Although YBCS and their partners reported online delivery was acceptable and benefited well-being, for couple-based MBIs to have benefits for relationship functioning, it may be necessary for couples to have the support of other couples and an instructor. Online delivery may be particularly acceptable and effective for clinical populations, including YBCS. Medical professionals may be more likely to recommend online-MBI programs to cancer survivors, because the programs are of little or no cost.",2020,"For YBCS and their partners, levels of perceived stress, anxiety, depression, and fatigue were lower after the intervention, in both conditions.","['individuals (I-MBI', 'young breast cancer survivors and their partners', 'Young breast cancer survivors (YBCS']","['online Mindfulness-Based Intervention (MBI', 'Online couples mindfulness-based intervention', 'YBCS']","['levels of perceived stress, anxiety, depression, and fatigue']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0334225,"For YBCS and their partners, levels of perceived stress, anxiety, depression, and fatigue were lower after the intervention, in both conditions.","[{'ForeName': 'Mollie A', 'Initials': 'MA', 'LastName': 'Price-Blackshear', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Pratscher', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Oyler', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Armer', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'An-Lin', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas, Kansas City, Missouri, USA.'}, {'ForeName': 'Maggie X', 'Initials': 'MX', 'LastName': 'Cheng', 'Affiliation': 'Department of Applied Mathematics, Illinois Institute of Technology, Chicago, Illinois, USA.'}, {'ForeName': 'Kathie', 'Initials': 'K', 'LastName': 'Records', 'Affiliation': 'University of Missouri-St. Louis, College of Nursing, St. Louis, Missouri, USA.'}, {'ForeName': 'Tipparat', 'Initials': 'T', 'LastName': 'Udmuangpia', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Departments of Anesthesiology & Perioperative Medicine, and Psychiatry, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ann Bettencourt', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1778150']
1147,32452561,Randomised clinical trial: standard of care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding.,"BACKGROUND


Early-transjugular intrahepatic porto-systemic shunt (TIPSS) has been recommended in international guidelines for high-risk patients with oesophageal variceal bleeding.
AIM


To validate the results of a previous randomised control trial which supports use of early-TIPSS.
METHODS


In a two-centre open-label parallel-group randomised control trial, patients with cirrhosis and acute variceal bleeding were recruited following haemostasis with vaso-active drugs and endoscopic band ligation. Participants were randomised to standard of care or early-TIPSS. The primary outcome was 1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension.
RESULTS


Fifty-eight patients (58 ± 11.12 years; 32.7% female) were randomised. After one year, seven patients died in the standard of care group and six in the early-TIPSS group, a 1-year survival of 75.9% vs 79.3% respectively (P = 0.79). Variceal rebleeding occurred in eight patients in the standard of care group compared with three patients in the early-TIPSS group (P = 0.09). Not all participants randomised to early-TIPSS received the intervention in time. For those receiving TIPSS per-protocol, variceal rebleeding rates were reduced (0% vs 27.6%, P = 0.04) but this had no effect on survival (76.9% vs 75.9%, P = 0.91). Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
CONCLUSIONS


Early-TIPSS reduced variceal rebleeding, increased encephalopathy but had no effect on survival in high-risk patients with oesophageal variceal bleeding. Early-TIPSS may not be feasible in many centres however, larger studies are needed. ClinicalTrials.gov reference: NCT02377141.",2020,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","['high-risk patients with oesophageal variceal bleeding', 'Fifty-eight patients (58\xa0±\xa011.12\xa0years; 32.7% female', 'patients with cirrhosis and acute variceal bleeding were recruited following', 'patients with cirrhosis and oesophageal variceal bleeding']","['transjugular intrahepatic porto-systemic shunt (TIPSS', 'standard of care or early-TIPSS', 'care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS', 'haemostasis with vaso-active drugs and endoscopic band ligation']","['Variceal rebleeding', 'rates of hepatic encephalopathy', 'Serious adverse events', 'survival', 'variceal rebleeding, increased encephalopathy', 'variceal rebleeding rates', '1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension', '1-year survival']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]","[{'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]",58.0,0.414712,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","[{'ForeName': 'Philip D J', 'Initials': 'PDJ', 'LastName': 'Dunne', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Lachlan', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Ireland', 'Affiliation': 'Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Shams', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Kasthuri', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Ewan H', 'Initials': 'EH', 'LastName': 'Forrest', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hayes', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15797']
1148,32246478,Results of the prematurely terminated TEMPLE randomized controlled trial in patients with myelodysplastic syndrome: liberal versus restrictive red blood cell transfusion threshold.,,2020,,['patients with myelodysplastic syndrome'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}]",[],[],,0.0599636,,"[{'ForeName': 'A J G', 'Initials': 'AJG', 'LastName': 'Jansen', 'Affiliation': 'Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'van den Bosch', 'Affiliation': 'Department of Oncology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Peter A W', 'Initials': 'PAW', 'LastName': 'Te Boekhorst', 'Affiliation': 'Department of Hematology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Schipperus', 'Affiliation': 'Department of Hematology, Leyenburg Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Erik A M', 'Initials': 'EAM', 'LastName': 'Beckers', 'Affiliation': 'Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.'}]",Transfusion,['10.1111/trf.15708']
1149,32502179,"Efficacy of topical bevacizumab 0.05% eye drops in dry eye disease: A double-masked, randomized trial.","The objective of this double-masked, placebo-controlled, randomized trial was to assess the efficacy and safety of bevacizumab 0.05% eye drops in dry eye patients. This study included Dry Eye Workshop Study (DEWS) Grade 3-4 dry eye participants (n = 31) whose tear break-up time (TBUT) was ≤5 seconds(s). Participants were randomized to undergo treatment with either bevacizumab 0.05% eye drops (n = 19) or placebo (n = 12). The primary outcome was TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade were secondary outcomes. All outcomes were measured at 1-, 4- and 12 weeks. TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001). Moreover, the improvement of TBUT in bevacizumab group versus placebo group at 4- and 12 weeks differed significantly from that difference at baseline (P = 0.002 and P = 0.003, respectively). The proportion of participants achieving increase of 3 seconds or more of TBUT at week 12 in the bevacizumab group was significantly greater than that in the placebo group (P = 0.02). Oxford scheme grade at 1-, 4- and 12 weeks differed significantly from the values at baseline in bevacizumab group (P = 0.001, P = 0.01, and P = 0.03, respectively). OSDI scores at 1-, 4- and 12-week follow-ups were significantly lower than that at baseline in bevacizumab group (P<0.001 at each follow-up). Schirmer test were not significantly different within or between groups (the lowest P = 0.92). No adverse events occurred in this study. Patients treated with bevacizumab 0.05% eye drops showed significant improvement in tear film stability, corneal staining and symptoms.",2020,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"['dry eye patients', 'dry eye disease']","['bevacizumab 0.05% eye drops', 'topical bevacizumab', 'bevacizumab', 'placebo']","['tear film stability, corneal staining and symptoms', 'OSDI scores', 'proportion of participants achieving increase of 3 seconds or more of TBUT', 'efficacy and safety', 'TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade', 'adverse events']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",31.0,0.52162,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"[{'ForeName': 'Ngamjit', 'Initials': 'N', 'LastName': 'Kasetsuwan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kanawat', 'Initials': 'K', 'LastName': 'Chantaralawan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Usanee', 'Initials': 'U', 'LastName': 'Reinprayoon', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lita', 'Initials': 'L', 'LastName': 'Uthaithammarat', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0234186']
1150,32502206,Digital versus analogue record systems for mass casualty incidents at sea-Results from an exploratory study.,"OBJECTIVE


Mis-triage may have serious consequences for patients in mass casualty incidents (MCI) at sea. The purpose of this study was to assess outcome, reliability and validity of an analogue and a digital recording system for triage of a MCI at sea.
METHODS


The study based on a triage exercise conducted with a cross-over-design. Forty-eight volunteers were presented a fictional MCI with 50 cases. The volunteers were randomly assigned to start with the analogue (Group A, starting with the analogue followed by the digital system) or digital system (Group B, starting with the digital followed by the analogue system). Triage score distribution and agreement between the triage methods and a predefined standard were reported. Reliability was analysed using Cronbach's Alpha and Cohen's Kappa. Validity was measured through sensitivity, specificity and predictive value. Treatment, period and carry-over-effects were analysed using a linear mixed-effects model.
RESULTS


The number of patients triaged (total: n = 3545) with the analogue system (n = 1914; 79.75%) was significantly higher (p = 0.001) than with the digital system (n = 1631; 67.96%). A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282). Ratio of under-triage was significantly smaller with the digital system (p = 0.001). Validity measured with Cronbach's Alpha and Cohen's Kappa was higher with the digital system. So was sensitivity (category; green: 80.67%, yellow: 73.24%, red: 83.54%; analogue: green: 93.28%, yellow: 82.36%, red: 94.04%) and specificity of the digital system (green: 78.07%, yellow: 63.75%, red: 66.25%; analogue: green: 85.50%, yellow: 79.88%, red: 91.50%). Comparing the predictive values and accuracy, the digital system showed higher scores than the analogue system. No significant patterns of carry-over-effects were observed.
CONCLUSIONS


Significant differences were found for the number of triages comparing the analogue and digital recording system. The digital system has a slightly higher reliability and validity than the analogue triage system.",2020,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"['patients in mass casualty incidents (MCI) at sea', 'Forty-eight volunteers were presented a fictional MCI with 50 cases']","['analogue (Group A, starting with the analogue followed by the digital system) or digital system', 'analogue']","['Ratio of under-triage', 'specificity of the digital system ', 'sensitivity, specificity and predictive value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1955957', 'cui_str': 'Mass Casualty Incidents'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",3545.0,0.0347985,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Henning', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Mustafa Sinan', 'Initials': 'MS', 'LastName': 'Bakir', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Lyubomir', 'Initials': 'L', 'LastName': 'Haralambiev', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schulz-Drost', 'Affiliation': 'Department of Trauma Surgery, Helios Kliniken Schwerin, Schwerin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hinz', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohlmann', 'Affiliation': 'Institute for Community Medicine, Section Methods in Community Medicine, University Medicine Greifswald, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Ekkernkamp', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gümbel', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0234156']
1151,32504207,Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).,"BACKGROUND


Patients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.
METHODS


In this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. Patients' postoperative courses were followed for 1 year after the index operation. Effectiveness and safety outcomes were compared at a level of significance of 5% between the two techniques.
RESULTS


A total of 100 out of 131 patients (76.3%) were evenly randomised to the small stitches and large stitches groups. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334). The overall comprehensive complication index was 14.4 ± 15.5 in the small stitches group and 19.9 ± 23.4 in the large stitches group (p = 0.168). Specifically, rates of surgical site infection (small stitches 30.0% versus large stitches 36.0%; p = 0.524) and burst abdomen (small stitches 4.0% versus large stitches 0.0%; p = 0.495) did not differ. After 1 year, incisional hernia rate was 7.5% in the small stitches group and 10.0% in the large stitches group (p > 0.999).
DISCUSSION


Both abdominal wall closure techniques investigated in this trial were feasible in relaparotomy patients. This exploratory trial revealed no noticeable difference in the effectiveness or safety of the small stitches technique with Monomax® 2-0 versus the large stitches technique with PDS II® 1 loop. Therefore, surgeons should stay with their preferred suture technique in relaparotomy patients.
TRIAL REGISTRATION


Deutsches Register Klinischer Studien ( www.germanctr.de ): DRKS00013001.",2020,The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334).,"['patients undergoing relaparotomy (ReLap study', 'patients scheduled for elective relaparotomy', 'relaparotomy patients', 'A total of 100 out of 131 patients (76.3', 'patients undergoing relaparotomy']","['abdominal wall closure techniques', 'abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop']","['burst abdomen', 'Effectiveness and safety outcomes', 'rates of surgical site infection', 'incisional hernia rate', 'overall comprehensive complication index', 'time for abdominal wall closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0023035', 'cui_str': 'Suture of abdominal wall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0085242', 'cui_str': 'Polydioxanone'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]","[{'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023035', 'cui_str': 'Suture of abdominal wall'}]",131.0,0.176231,The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334).,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. pascal.probst@med.uni-heidelberg.de.'}, {'ForeName': 'Dinh Thien-An', 'Initials': 'DT', 'LastName': 'Tran', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Harnoss', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heger', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Alina S', 'Initials': 'AS', 'LastName': 'Ritter', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Doerr-Harim', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01903-1']
1152,32514756,"Effect of zinc supplementation on quality of life and sleep quality in young women with premenstrual syndrome: a randomized, double-blind, placebo-controlled trial.","INTRODUCTION


Premenstrual syndrome is a prevalent disorder affecting a large number of women in their reproductive ages. Nutritional importance of zinc has been known for a long time and studies have shown that zinc can positively affect psychological disorders.
PURPOSE


The aim of this study was to evaluate the effects of zinc supplementation on quality of life and sleep quality of young women diagnosed with premenstrual syndrome.
METHODS


This randomized, double-blind, placebo-controlled trial was carried out on 60 young university women that were allocated into two groups of intervention who took 30 mg/day of elemental zinc or placebo for three months. Pre- and post-intervention, participants completed the questionnaires of quality of life and Pittsburgh sleep quality.
RESULTS


After supplementation, quality of life score in the intervention group was increased (+ 9.185 ± 7.29, P < 0.001), however, in comparison with the control group, results were not significant; Physical aspects of quality of life score were significantly enhanced (+ 5.55 ± 3.71 vs. + 0.13 ± 2.87, P < 0.001). Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
CONCLUSION


Zinc supplementation for 12 weeks had beneficial effects on physical aspects of quality of life in young women with premenstrual syndrome.",2020,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
","['60 young university women', 'young women with premenstrual syndrome', 'young women diagnosed with premenstrual syndrome']","['Zinc supplementation', 'elemental zinc or placebo', 'zinc supplementation', 'Pre- and post-intervention', 'placebo']","['quality of life', 'questionnaires of quality of life and Pittsburgh sleep quality', 'quality of life score', 'quality of life and sleep quality', 'Physical aspects of quality of life score', 'Sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",60.0,0.426181,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Farhang', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. r_amani@nutr.mui.ac.ir.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05628-w']
1153,32521250,"Efficacy and safety of TS-121, a novel vasopressin V 1B  receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study.","Vasopressin 1B (V 1B ) receptor has a pivotal role in the regulation of the hypothalamus-adrenal-pituitary axis, and V 1B  receptor antagonists have shown efficacy in a number of preclinical models of depression. The efficacy and safety of, TS-121 (active ingredient: THY1773), a novel V 1B  receptor antagonist, was investigated in patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy. In a randomized, double-blind, placebo-controlled phase 2 study, 51 MDD patients (43 of whom completed the study) were randomly assigned to either TS-121 10 mg, 50 mg or placebo for 6 weeks treatment period. The primary endpoint was change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6. The study was conducted from Jul 2017 to Dec 2018. The changes from baseline in MADRS score at week 6 (Least Square Mean [95% Confidence interval] were: TS-121 10 mg (-9.0 [-13.9, -4.1]), TS-121 50 mg (-9.0 [-13.4, -4.5]), and placebo (-6.4 [-10.7, -2.2]). TS-121 groups showed greater numerical reductions in MADRS score change from baseline compared to placebo, though these reductions did not achieve statistical significance. Similar trends of numerically greater improvements in TS-121 groups were observed across secondary endpoints. Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint. These findings, combined with favorable safety and tolerability, warrant further investigation of TS-121 in an adequately powered study in patients with MDD.",2020,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"['51 MDD patients (43 of whom completed the study', 'patients with MDD', 'patients with major depressive disorder', 'patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy', 'Jul 2017 to Dec 2018']","['TS-121, a novel vasopressin V 1B  receptor antagonist', 'Vasopressin 1B (V 1B ) receptor', 'TS-121', 'TS-121 50\xa0mg', 'TS-121 10\xa0mg, 50\xa0mg or placebo', 'placebo']","['MADRS score', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'MADRS score change', 'Higher baseline urinary and hair cortisol levels']","[{'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",51.0,0.556683,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kamiya', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA. Electronic address: ma-kamiya@taisho.co.jp.'}, {'ForeName': 'Helene D', 'Initials': 'HD', 'LastName': 'Sabia', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marella', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit Street, Bulfinch 351, Boston, MA, 02114, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': 'University of Texas Dell Medical School in Austin, 1601 Trinity Street, Stop Z0600, Office HDB 4.112, Austin, TX, 78712, USA.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Umeuchi', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Michihiko', 'Initials': 'M', 'LastName': 'Iijima', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Chaki', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nishino', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.017']
1154,32524424,High efavirenz levels but not neurofilament light plasma levels are associated with poor neurocognitive functioning in asymptomatic HIV patients.,"The aim of this study is to assess the effect of efavirenz exposure on neurocognitive functioning and investigate plasma neurofilament light (Nfl) as a biomarker for neurocognitive damage. Sub-analysis of the ESCAPE-study, a randomised controlled trial where virologically suppressed, cognitively asymptomatic HIV patients were randomised (2:1) to switch to rilpivirine or continue on efavirenz. At baseline and week 12, patients underwent an extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels were measured. Subgroups of elevated (≥ 4.0 mg/L) and therapeutic (0.74 to< 4.0 mg/L) baseline efavirenz concentration were made. Differences between these groups in baseline NPA Z-scores and in delta scores after efavirenz discontinuation were assessed. Nfl level was measured using an ELISA analysis using single molecule array (Simoa) technology. Correlation of plasma NFL with NPA Z-scores was evaluated using a linear mixed model. The elevated group consisted of 6 patients and the therapeutic group of 48. At baseline, the elevated group showed lower composite Z-scores (median - 1.03; IQR 0.87 versus 0.27; 0.79. p 0.02). This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01). In the switch group, the elevated group improved more on composite scores after discontinuing efavirenz (mean 0.58; SD 0.32 versus 0.22; 0.54, p 0.15). No association between plasma Nfl and composite Z-score was found. High efavirenz exposure is associated with worse cognitive functioning compared with patients with therapeutic concentrations. Plasma Nfl is not a suitable biomarker to measure cognitive damage in this group.",2020,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","['cognitively asymptomatic HIV patients', 'asymptomatic HIV patients']","['efavirenz', 'rilpivirine or continue on efavirenz']","['plasma Nfl and composite Z-score', 'subdomains verbal', 'executive functioning', 'composite scores', 'cognitive functioning', 'extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels', 'lower composite Z-scores', 'plasma NFL with NPA Z-scores']","[{'cui': 'C0343751', 'cui_str': 'Asymptomatic human immunodeficiency virus infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",6.0,0.0736464,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","[{'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Hakkers', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands. c.s.hakkers@umcutrecht.nl.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Hermans', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': 'Division of Laboratory and Pharmacy, Clinical Pharmacy, University Medical Center (UMC) Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Inge M W', 'Initials': 'IMW', 'LastName': 'Verberk', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Joop E', 'Initials': 'JE', 'LastName': 'Arends', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Andy I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}]",Journal of neurovirology,['10.1007/s13365-020-00860-1']
1155,32525955,Simulation-based training using a vessel phantom effectively improved first attempt success and dynamic needle-tip positioning ability for ultrasound-guided radial artery cannulation in real patients: An assessor-blinded randomized controlled study.,"BACKGROUND


We evaluated whether a simulation-based training with a vessel phantom improves the basic skills of a novice required for ultrasound-guided radial artery cannulation in real patients. In addition, we analysed whether repeated simulation training sets with an inter-training interval would accelerate the learning curve.
METHODS


From March 2019 to July 2019, twenty-one anesthesiology residents were randomized into either a simulation group (n = 11) or control group (n = 10). Residents performed a total of 84 ultrasound-guided radial artery cannulations in real patients. The simulation group participated in two sets of simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval. Trainee's performance proficiency was scored using a developed checklist, and a learning curve for each training set was constructed. To evaluate the effectiveness of our training curriculum in skill transfer, each resident performed four ultrasound-guided radial artery cannulations in real patients. The primary outcome was first attempt success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients.
RESULTS


The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively). A reduced number of sessions was required to reach a plateau score on the learning curve in the repeated training set compared in the first-set (7 (5-8) vs. 3 (2-4), P = 0.003, respectively).
CONCLUSIONS


Simulation-based training using a vessel phantom effectively improved the first attempt success rate for ultrasound-guided radial artery cannulation in real patients and the dynamic needle-tip positioning ability by ultrasound transducer in novice anesthesiology residents. In addition, repeated training curriculum accelerated the learning curve for recall skill proficiency and reduced inter-individual variability for skill acquisition.
CLINICAL TRIAL REGISTRATION


Clinical Research Information Service (KCT0003471, Principle investigator: Jeong Jin Min, Date of registration: 06/March/2019).",2020,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","['From March 2019 to July 2019, twenty-one anesthesiology residents', 'real patients']","['simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval', '84 ultrasound-guided radial artery cannulations', 'ultrasound-guided radial artery cannulation']","['success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients', 'success rate and dynamic needle-tip positioning ability by ultrasound transducer']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}]",,0.0489383,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","[{'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0234567']
1156,32527261,Social response to the delivery of HIV self-testing in households: experiences from four Zambian HPTN 071 (PopART) urban communities.,"BACKGROUND


Door-to-door distribution of HIV self-testing kits (HIVST) has the potential to increase uptake of HIV testing services (HTS). However, very few studies have explored the social response to and implications of door-to-door including secondary distribution of HIVST on household relations and the ability of individuals to self-test with or without supervision within households.
METHODS


A CRT of HIVST distribution was nested within the HPTN 071 (PopART) trial, in four Zambian communities randomised to receive the PopART intervention. The nested HIVST trial aimed to increase knowledge of HIV status at population level. Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities were randomly allocated to either the PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST (33 clusters). In clusters randomised to HIVST, trained Community HIV care provider (CHiPs) visited households and offered individuals aged ≥ 16 and eligible for an offer of HTS the choice of HIV testing using HIVST or routine door-to-door HTS (finger-prick RDT). To document participants' experiences with HIVST, Interviews (n = 40), observations (n = 22) and group discussions (n = 91) with household members and CHiPs were conducted. Data were coded using Atlas.ti 7 and analysed thematically.
RESULTS


The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs. Door-to-door distribution of HIVST kits was appreciated for being novel, convenient, private, empowering, autonomous and easy-to-use. Literacy and age influenced accurate usage of HIVST kits. The novelty of using oral fluids to test for HIV raised questions, some anxiety and doubts about the accuracy of HIVST. Although HIVST protected participants from experiencing clinic-based stigma, it did not address self-stigma. Within households, HIVST usually strengthened relationships but, amongst couples, there were a few reports of social harms.
CONCLUSION


Door-to-door distribution of HIVST as a choice for how to HIV test is appreciated at community level and provides an important testing option in the sub-Saharan context. However, it should be accompanied by counselling to manage social harms and by supporting those testing HIV-positive to link to care.",2020,"The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs.","[""participants' experiences with HIVST, Interviews (n\u2009=\u200940), observations (n\u2009=\u200922) and group discussions (n\u2009=\u200991) with household members and CHiPs were conducted"", ' trained Community HIV care provider (CHiPs) visited households and offered individuals aged\u2009≥\u200916 and eligible for an offer of HTS the choice of HIV testing using', 'households: experiences from four Zambian HPTN 071 (PopART) urban communities', 'Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities']","['HIVST', 'PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST', 'PopART intervention', 'HIV self-testing kits (HIVST', 'HIVST or routine door-to-door HTS (finger-prick RDT']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}]",[],,0.0271676,"The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs.","[{'ForeName': 'Chiti', 'Initials': 'C', 'LastName': 'Bwalya', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia. Bwalya@zambart.org.zm.'}, {'ForeName': 'Musonda', 'Initials': 'M', 'LastName': 'Simwinga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Clinical Research Department, Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Lwiindi', 'Initials': 'L', 'LastName': 'Gwanu', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Able', 'Initials': 'A', 'LastName': ""Hang'andu"", 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chama', 'Initials': 'C', 'LastName': 'Mulubwa', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwelwa', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Mwinga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS research and therapy,['10.1186/s12981-020-00287-y']
1157,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND


External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
OBJECTIVE


To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
METHODS


Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
RESULTS


Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
CONCLUSIONS


ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005']
1158,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND


Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates.
OBJECTIVE


We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation.
METHODS


We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms.
RESULTS


Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013).
CONCLUSIONS


Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007']
1159,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1160,32682996,THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design.,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.",2020,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","['Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress', 'teens with type 1 diabetes', 'adolescents with T1D']","['Diabetes Education + text-message-based Positive Affect intervention', 'Positive psychology intervention']","[""adolescents' diabetes distress, self-management, and glycemic control"", 'diabetes distress']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0417244,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Vanderbilt University Medical Center, USA. Electronic address: sarah.jaser@vumc.org.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Datye', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Morrow', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Sinisterra', 'Affiliation': ""Children's National Hospital, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'LeStourgeon', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Fayo', 'Initials': 'F', 'LastName': 'Abadula', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Streisand', 'Affiliation': ""Children's National Hospital, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106086']
1161,32546187,Correction to: Effectiveness of a multi-level intervention to reduce men's perpetration of intimate partner violence: a cluster randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"[""men's perpetration of intimate partner violence""]",['multi-level intervention'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0718428,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Christofides', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa. nicola.christofides@wits.ac.za.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Dumisani', 'Initials': 'D', 'LastName': 'Rebombo', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Ruari-Santiago', 'Initials': 'RS', 'LastName': 'McBride', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Shehnaz', 'Initials': 'S', 'LastName': 'Munshi', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Pino', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Abdelatif', 'Affiliation': 'South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Peacock', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Jewkes', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}]",Trials,['10.1186/s13063-020-04386-z']
1162,32548849,Duration of adhesion of swallowed alginates to distal oesophageal mucosa: implications for topical therapy of oesophageal diseases.,"BACKGROUND


We have previously shown, ex vivo, that alginate solutions can have a topical protective effect on oesophageal mucosal biopsies exposed to simulated gastric juice. Oesophageal mucosal impedance can measure the duration of mucosal adherence of ionic solutions since the impedance drops when the solution is present, and rises to baseline as the solution clears.
AIM


To investigate the in vivo duration of adhesion of swallowed alginate solution to distal oesophageal mucosa.
METHODS


We studied 20 healthy volunteers and 10 patients with heartburn. A pH-impedance catheter was inserted, and baseline distal channel oesophageal impedance measured. Healthy volunteers received 10 mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry (saline mixed with sucralose), given in a randomised, single-blinded order over three visits. Patients received either sodium alginate or placebo on two visits. Initial impedance drop was measured, then 1-minute mean impedance was measured each minute until ≥75% recovery to baseline.
RESULTS


In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01). In patients, sodium alginate adhered to the oesophageal mucosa for longer than placebo (9.0 (5.4) vs 3.7 (4.1), P < 0.01).
CONCLUSIONS


Sodium alginate solution adhered to the oesophageal mucosa for significantly longer than placebo or viscous slurry. This demonstrates that alginates could confer a protective benefit due to mucoadhesion and can be a basis for further development of topical protectants and for topical drug delivery in oesophageal disease.",2020,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","['oesophageal diseases', 'healthy volunteers', '20 healthy volunteers and 10 patients with heartburn', 'distal oesophageal mucosa', 'Healthy volunteers']","['sodium alginate or placebo', '10\xa0mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry ', 'saline mixed with sucralose', 'swallowed alginate solution', 'placebo']",['oesophageal mucosa'],"[{'cui': 'C0014852', 'cui_str': 'Disorder of esophagus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]","[{'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]",20.0,0.0734851,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Sonmez', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sifrim', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Woodland', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15884']
1163,32546347,"Re: Timothy J. Wilt, Tien N. Vo, Lisa Langsetmo, et al. Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT). Eur Urol 2020;77:713-724: External Validity of the Updated Prostate Cancer Intervention Versus Observation Trial (PIVOT).",,2020,,['Clinically Localized Prostate Cancer'],"['Radical Prostatectomy or Observation', 'Updated Prostate Cancer Intervention', 'https://doi.org/10.1016/j.eururo.2020.02.009']",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0236809,,"[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Rakic', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Keeley', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Abdollah', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA. Electronic address: firas.abdollah@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2020.05.002']
1164,32544161,Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe.,"BACKGROUND


Voluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up.
METHODS


The RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively.
RESULTS


Clients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts.
CONCLUSION


Results strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.",2020,"Wage and age did not influence text response rates or potential AE texts.
","['100 texting clients filled a self-administered usability survey on day 14', 'post-operative follow-up for voluntary medical male circumcision in Zimbabwe', '362 adult MC clients with cell phones into 2wT; these men', 'Men with concerns solicited provider guidance and reassurance offered via text']",[],"['Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality', '2wT acceptability and usability', 'Response rates', 'Usability and acceptability', 'Clients felt 2wT saved them time and money']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]",[],"[{'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",362.0,0.0385762,"Wage and age did not influence text response rates or potential AE texts.
","[{'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korir', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Wambua', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Marrianne', 'Initials': 'M', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}]",PloS one,['10.1371/journal.pone.0233234']
1165,32544221,Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection.,"BACKGROUND


Finding a suitable treatment for HCV patients with swallowing disorders is still a major challenge. In practice, direct-acting antivirals are crushed without knowledge of adequate absorption. Crushing can alter drug exposure, possibly leading to treatment failure, development of resistance or toxicity. Currently, there is no information about crushing of the fixed-dose combination tablet of elbasvir/grazoprevir; therefore, crushing of this tablet is not recommended.
OBJECTIVES


To investigate the influence of crushing on the pharmacokinetics of the elbasvir/grazoprevir fixed-dose combination tablet.
METHODS


We conducted an open-label, two-period, randomized, cross-over, Phase I, single-dose trial in 11 healthy adult volunteers. Subjects randomly received whole-tablet elbasvir/grazoprevir or crushed and suspended elbasvir/grazoprevir in a fasted state. Pharmacokinetic similarity criteria (90% CIs lie within 70%-143% acceptance range) were used for AUC0-∞ and AUC0-72.
RESULTS


Mean plasma concentration-time curves of elbasvir and grazoprevir showed similar pharmacokinetic profiles. The primary pharmacokinetic parameters AUC0-∞ and AUC0-72 of elbasvir and grazoprevir after intake of a crushed tablet were on average 12%-16% higher compared with the whole tablet, but 90% CIs were all within the predefined boundaries of pharmacokinetic similarity. Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir. No serious adverse events were reported during the trial.
CONCLUSIONS


Pharmacokinetic similarity could be demonstrated for a crushed and suspended tablet compared with a whole tablet, without impacting drug safety or efficacy. Crushed and suspended administration of elbasvir/grazoprevir can be used in patients with swallowing disorders.",2020,Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir.,"['11 healthy adult volunteers', 'HCV patients with swallowing disorders', 'patients with swallowing disorders']","['whole-tablet elbasvir/grazoprevir or crushed and suspended elbasvir/grazoprevir', 'elbasvir/grazoprevir', 'elbasvir/grazoprevir fixed-dose combination tablet']","['serious adverse events', 'primary pharmacokinetic parameters AUC0-∞ and AUC0-72 of elbasvir and grazoprevir after intake of a crushed tablet', 'Cmax of elbasvir']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4080052', 'cui_str': 'elbasvir'}]",11.0,0.0342333,Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir.,"[{'ForeName': 'Daniëlle W M', 'Initials': 'DWM', 'LastName': 'Pijnenburg', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Minou', 'Initials': 'M', 'LastName': 'van Seyen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Evertine J', 'Initials': 'EJ', 'LastName': 'Abbink', 'Affiliation': 'Radboudumc Technology Center Clinical Studies, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa230']
1166,32556348,Gait improvement in adults with hemiparesis using a rolling cane: A cross-over trial.,"OBJECTIVE


To assess the changes in gait parameters in adults with hemiparesis using a rolling cane (quadripod cane with small wheels; Wheeleo®) compared with a classical quadripod cane.
DESIGN


A prospective, multicentric, cross-over randomized trial.
PARTICIPANTS


Thirty-two ambulatory adults with hemiparesis.
METHODS


Participants were assessed using a quadripod cane and a rolling cane. Outcome measures were changes in: walking speed during a 10-m walk test and a 6-min walk test; frequency of 2-step gait; physiological cost index; number of therapist interventions to control the balance; perceived exertion; and participant satisfaction.
RESULTS


The following outcomes were improved with the use of a rolling cane: walking speed during a 10-m walk test at comfortable (+22%: p<0.001) and maximal (+30: p<0.001) speeds; walking speed (+50%: p<0.001) and distance (+49%: p<?0.001) during a 6-min walk test; and the frequency of 2-step gait. The physiological cost index, perceived exertion, and number of therapist interventions to control the balance remained unchanged. Participant satisfaction improved.
CONCLUSION


A rolling cane, Wheeleo®, increases walking speed in adults with hemiparesis without additional risk of falls.",2020,The following outcomes were improved with the use of a rolling cane: walking speed during a 10-m walk test at comfortable (+22%: p < 0.001) and maximal (+30: p < 0.001) speeds; walking speed (+50%: p < 0.001) and distance (+49%: p < 0.001) during a 6-min walk test; and the frequency of 2-step gait.,"['adults with hemiparesis using a', 'Participants were assessed using a quadripod cane and a rolling cane', 'adults with hemiparesis without additional risk of falls', 'adults with hemiparesis using a rolling cane', 'Thirty-two ambulatory adults with hemiparesis']","['classical quadripod cane', 'rolling cane (quadripod cane with small wheels; Wheeleo®']","['frequency of 2-step gait', 'walking speed', 'rolling cane: walking speed during a 10-m walk test at comfortable', 'changes in: walking speed during a 10-m walk test and a 6-min walk test; frequency of 2-step gait; physiological cost index; number of therapist interventions to control the balance; perceived exertion; and participant satisfaction', 'physiological cost index, perceived exertion, and number of therapist interventions', 'gait parameters', 'Participant satisfaction improved', 'Gait improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",32.0,0.113001,The following outcomes were improved with the use of a rolling cane: walking speed during a 10-m walk test at comfortable (+22%: p < 0.001) and maximal (+30: p < 0.001) speeds; walking speed (+50%: p < 0.001) and distance (+49%: p < 0.001) during a 6-min walk test; and the frequency of 2-step gait.,"[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Deltombe', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Université catholique de Louvain, Cliniques universitaires de Mont-Godinne, BE-5530 Yvoir, Belgium. E-mail: thierry.deltombe@uclouvain.be.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Leeuwerck', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Jamart', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frederick', 'Affiliation': ''}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Dellicour', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2705']
1167,32553881,Efficacy and safety of weekly rifapentine and isoniazid for tuberculosis prevention in Chinese silicosis patients: a randomized controlled trial.,"OBJECTIVE


The aim was to evaluate the efficacy, safety and completion rate of 3-month, once-weekly rifapentine and isoniazid for tuberculosis (TB) prevention among Chinese silicosis patients.
METHODS


Male silicosis patients without human immunodeficiency virus infection, aged 18 years to 65 years, with or without latent TB infection, were randomized 1:1 to receive rifapentine/isoniazid under direct observation (3RPT/INH group) or were untreated (observation group). Active TB incidence was compared between the two groups with 37 months of follow-up. Safety profile and complete rates were evaluated.
RESULTS


A total of 1227 adults with silicosis were screened; 513 eligible participants were enrolled and assigned to 3RPT/INH (n = 254) vs. observation (n = 259). Twenty-eight participants were diagnosed with active TB, and 9 and 19 in the 3RPT/INH group and observation groups, respectively. In the intention-to-treat analysis, the cumulative active TB rate was 3.5% (9/254) in the 3RPT/INH group and 7.3% (19/259) in the observation group (log rank p 0.055). On per protocol analysis, the cumulative active TB rates were 0.7% (1/139) and 7.3% (19/259), respectively (log rank p 0.01). Owing to an unexpected high frequency of adverse events (70.4%) and Grade 3 or 4 AEs (7.9%), the completion rate of the 3RPT/INH regimen was 54.7% (139/254). Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity.
DISCUSSION


Weekly rifapentine/isoniazid prophylaxis prevented active TB among Chinese people with silicosis when taken, irrespective of LTBI screening; efficacy was reduced by lack of compliance. The regimen must be used with caution because of the high rates of adverse effects.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number: NCT02430259.",2020,"Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity.
","['Chinese silicosis patients', 'Twenty-eight participants were diagnosed with active TB, 9 and 19 in the 3RPT/INH group and observation groups, respectively', 'Male silicosis patients without human immunodeficiency virus infection, aged 18\xa0years to 65\xa0years, with or without latent TB infection', 'n=254) vs observation (n=259', '1,227 adults with silicosis were screened; 513 eligible participants']","['3RPT/INH', 'rifapentine/isoniazid under direct observation (3RPT/INH group) or were untreated (observation group', 'rifapentine and isoniazid', 'rifapentine/isoniazid prophylaxis']","['Active TB incidence', 'completion rate', 'Safety profile and complete rates', 'Efficacy and safety', 'efficacy, safety and completion rate', 'flu-like systemic drug reactions', 'cumulative active TB rate', 'adverse events', 'cumulative active TB rates', 'active TB', 'hepatotoxicity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0037116', 'cui_str': 'Pneumoconiosis due to silica'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]",1227.0,0.444171,"Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity.
","[{'ForeName': 'Qiao-Ling', 'Initials': 'QL', 'LastName': 'Ruan', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Xi-Tian', 'Initials': 'XT', 'LastName': 'Huang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Qing-Luan', 'Initials': 'QL', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Xue-Feng', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Ke-Chuan', 'Initials': 'KC', 'LastName': 'Pan', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Yao-Jie', 'Initials': 'YJ', 'LastName': 'Shen', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Cai', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Ling', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jin-Jing', 'Initials': 'JJ', 'LastName': 'Hong', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Xiao-Dan', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Chun-Lian', 'Initials': 'CL', 'LastName': 'Ma', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Guan-Qing', 'Initials': 'GQ', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Xiu-Zhen', 'Initials': 'XZ', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jin-Chao', 'Initials': 'JC', 'LastName': 'Mao', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Tian-Zhou', 'Initials': 'TZ', 'LastName': 'Wu', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Miao-Yao', 'Initials': 'MY', 'LastName': 'Lin', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Shao', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China. Electronic address: lingyun26@fudan.edu.cn.'}, {'ForeName': 'Wen-Hong', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China; Key Laboratory of Medical Molecular Virology (MOE/MOH) and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 200032, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China. Electronic address: zhangwenhong@fudan.edu.cn.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.06.008']
1168,32553888,Effect of practical hyperoxic high-intensity interval training on exercise performance.,"This study investigated the effect of a practical hyperoxic high-intensity interval training (HIIT) on aerobic and anaerobic exercise capacity. Sixteen male athletes were randomized into 2 groups: normoxic HIIT (NHIIT, n = 8) group or hyperoxic HIIT (HHIIT, n = 8) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia. All training sessions were performed until exhaustion. Participants performed maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests before and after the training period. Maximal oxygen uptake (P < 0.01) increased significantly in both groups. Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01). Mean power output during maximal exercise increased significantly only in the HHIIT group (P = 0.02). This study demonstrated that a practical hyperoxic HHIIT might be effective for improving aerobic capacity and anaerobic performance.",2020,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,['Sixteen male athletes'],"['normoxic HIIT (NHIIT, n\u2009=\u20098) group or hyperoxic HIIT (HHIIT, n\u2009=\u20098) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia', 'maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests', 'practical hyperoxic high-intensity interval training', 'practical hyperoxic high-intensity interval training (HIIT']","['Mean power output during maximal exercise', 'Blood lactate curve during submaximal exercise', 'Maximal oxygen uptake', 'aerobic capacity and anaerobic performance', 'aerobic and anaerobic exercise capacity', 'exercise performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",16.0,0.0253253,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,"[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, 101-2 Yagotohonmachi, Showa-ku, Nagoya, 466-8666, Japan; Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan. Electronic address: kon.michihiro@gmail.com.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nakagaki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan; Department of Sports Sciences, Yamanashi Gakuin University, 2-4-5 Sakaori, Kofu, Yamanashi, 400-8575, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Ebi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103481']
1169,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).
CONCLUSIONS


As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008']
1170,32555011,Effect of Tactile Experience During Preterm Infant Feeding on Clinical Outcomes.,"BACKGROUND


Although the survival rate of very preterm infants has improved, rates of subsequent neurobehavioral disabilities remain high. One factor implicated in poor neurobehavioral and developmental outcomes is hospitalization and inconsistent caregiving patterns in the neonatal intensive care unit. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies may stop progression of damage, particularly when these strategies are used during the most sensitive periods of neural plasticity 2-3 months before term age.
OBJECTIVE


The purpose of this analysis was to test the effect of a patterned feeding experience involving a tactile component (touch and/or holding) provided during feedings on preterm infants' clinical outcomes, measured by oral feeding progress, as an early indicator of neurodevelopment.
METHODS


We used an experimental, longitudinal, two-group random assignment design. Preterm infants (n = 120) were enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience or to a control group receiving usual feeding care.
RESULTS


Analysis of data from 91 infants showed that infants receiving touch at more than 25% of early gavage feedings achieved full oral feeding more quickly; as touch exposure increased, time from first oral to full oral feeding decreased. There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
DISCUSSION


Neurological expectation during critical periods of development is important for infants. However, a preterm infant's environment is not predictable: Caregivers change regularly, medical procedures dictate touch and holding, and care provision based on infant cues is limited. Current knowledge supports caregiving that occurs with a naturally occurring sensation (i.e., hunger), is provided in a manner that is congruent with the expectation of the neurological system, and occurs with enough regularity to enhance neuronal and synaptic development. In this study, we modeled an experience infants would ""expect"" if they were not in the neonatal intensive care unit and demonstrated a shorter time from first oral feeding to full oral feeding, an important clinical outcome with neurodevelopmental implications. We recommend further research to determine the effect of patterned caregiving experiences on other areas of neurodevelopment, particularly those that may occur later in life.",2020,"There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
",['Preterm infants (n = 120'],"['experimental group receiving a patterned feeding experience or to a control group receiving usual feeding care', 'Tactile Experience', 'patterned feeding experience involving a tactile component (touch and/or holding']",['survival rate'],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",120.0,0.0399053,"There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
","[{'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ""Rita H. Pickler, PhD, RN, FAAN, is FloAnn Sours Easton Professor of Child and Adolescent Health, College of Nursing, The Ohio State University, Columbus. Jareen Meinzen-Derr, PhD, MPH, is Professor, Department of Pediatrics, University of Cincinnati College of Medicine, and Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Ohio. Margo Moore, MS, RN, is Research Nurse III, Division of Infectious Disease, Cincinnati Children's Hospital Medical Center, Ohio. Stephanie Sealschott, MS, RN, is PhD Candidate, College of Nursing, The Ohio State University, Columbus. Karin Tepe, BS, RN, is Research Nurse in Neonatology, Cincinnati Children's Hospital Medical Center, Ohio.""}, {'ForeName': 'Jareen', 'Initials': 'J', 'LastName': 'Meinzen-Derr', 'Affiliation': ''}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sealschott', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Tepe', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000453']
1171,32561942,[A superoxide dismutase mimetic (GC4419) vs. placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer: a phase-IIb randomized double-blind study].,,2020,,['head and neck cancer'],"['superoxide dismutase mimetic (GC4419) vs. placebo', 'radiotherapy and cisplatin']",['severe oral mucositis'],"[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",,0.573769,,"[{'ForeName': 'Irenäus A', 'Initials': 'IA', 'LastName': 'Adamietz', 'Affiliation': 'Klinik für Strahlentherapie und Radio-Onkologie, Marien Hospital Herne Universitätsklinik, Ruhr-Universität Bochum, Hölkeskampring\xa040, 44625, Herne, Deutschland. irenaeus.adamietz@elisabethgruppe.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01639-3']
1172,32562682,"Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial.","BACKGROUND


In A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up.
METHODS


ARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion. Patients were randomly assigned (1:1) by a web-based data collection system, stratified by clinical centre in a random permuted block design with block sizes of two, four, and six, to medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number). Although patients and investigators at a given centre were not masked to treatment assignment, investigators at other centres and those in the clinical coordinating centre were not informed of assignment or outcomes at any of the centres. The primary outcome was time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care, and monitored by an independent committee using an adaptive approach with interim analyses. Enrolment began on April 4, 2007, and was halted on April 15, 2013, after which follow-up continued until July 15, 2015. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00389181.
FINDINGS


Of 1740 patients screened, 226 were randomly assigned to medical management alone (n=110) or medical management plus interventional therapy (n=116). During a mean follow-up of 50·4 months (SD 22·9), the incidence of death or symptomatic stroke was lower with medical management alone (15 of 110, 3·39 per 100 patient-years) than with medical management with interventional therapy (41 of 116, 12·32 per 100 patient-years; hazard ratio 0·31, 95% CI 0·17 to 0·56). Two patients in the medical management group and four in the interventional therapy group (two attributed to intervention) died during follow-up. Adverse events were observed less often in patients allocated to medical management compared with interventional therapy (283 vs 369; 58·97 vs 78·73 per 100 patient-years; risk difference -19·76, 95% CI -30·33 to -9·19).
INTERPRETATION


After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation. The data concerning the disparity in outcomes should affect standard specialist practice and the information presented to patients. The even longer-term risks and differences between the two therapeutic approaches remains uncertain.
FUNDING


National Institute of Neurological Disorders and Stroke for the randomisation phase and Vital Projects Fund for the follow-up phase.",2020,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","['patients with an unruptured brain arteriovenous malformation', '1740 patients screened, 226 were randomly assigned to', '39 clinical centres in nine countries', 'Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion', 'unruptured brain arteriovenous malformations (ARUBA']","['interventional therapy versus medical management alone', 'medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number', 'medical management alone (n=110) or medical management plus interventional therapy']","['death or symptomatic stroke', 'Adverse events', ""time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care"", 'symptomatic stroke or death', 'incidence of death or symptomatic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0003857', 'cui_str': 'Congenital arteriovenous malformation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C3846112', 'cui_str': 'Stereotactic radiosurgery'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",226.0,0.149025,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","[{'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Mohr', 'Affiliation': 'Doris and Stanley Tananbaum Stroke Center, The Neurological Institute, Columbia University Irving Medical Center, New York, NY, USA. Electronic address: jpm10@cumc.columbia.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Department of Neurology, Klinikum Frankfurt/Oder, Frankfurt/Oder, Germany.'}, {'ForeName': 'Rüdiger von', 'Initials': 'RV', 'LastName': 'Kummer', 'Affiliation': 'Department of Neuroradiology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California, San Francisco, CA, USA.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Albert Einstein Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology and Neurosurgery, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Neuroradiology, APHP-Hôpital Lariboisière, Université Paris Diderot-Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Libman', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pile-Spellman', 'Affiliation': 'Department of Neuroradiology, NYU-Winthrop Medical Center, Mineola, NY, USA.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Harkness', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cordonnier', 'Affiliation': 'Université Lille, Inserm, CHU Lille, U1172, LilNCog, Lille Neuroscience and Cognition, Lille, France.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moquete', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Department of Interventional Neuroradiology, Jean Minjoz Hospital, University of Franche Comté, Besançon, France.'}, {'ForeName': 'Catharina J M', 'Initials': 'CJM', 'LastName': 'Klijn', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stapf', 'Affiliation': ""Neuroscience Axis, Neurovascular Group, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Division of Neurology, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada; Department of Neurosciences, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30181-2']
1173,32562683,Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.,"BACKGROUND


Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial.
METHODS


REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 . Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.
FINDINGS


Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1-5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85-1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
INTERPRETATION


Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated.
FUNDING


Eli Lilly and Company.",2020,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
","['371 sites in 24 countries', '8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned', 'men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 ', 'Between Aug 18, 2011, and Aug 14, 2013, 9901 participants', 'type 2 diabetes', 'people with type 2 diabetes']","['placebo', 'dulaglutide (1·5 mg) or an equal volume of matching placebo', 'dulaglutide', 'glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide']","['hazard of substantive cognitive impairment', 'stroke, myocardial infarction, or death from cardiovascular or unknown causes', 'cognitive outcome', 'Cognitive function', 'cognitive impairment', 'Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",9901.0,0.689964,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
","[{'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cukierman-Yaffe', 'Affiliation': 'Endocrinology Institute, Gertner Institute, Sheba Medical Center, Ramat-Gan, Israel; Epidemiology Department, Sackler School of Medicine, Herceg Institute of Aging, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Luis-Emilio', 'Initials': 'LE', 'LastName': 'García-Pérez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Angelyn', 'Initials': 'A', 'LastName': 'Bethel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, India.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health and Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital, Warsaw, Poland.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Center, Sofia, Bulgaria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30173-3']
1174,32562684,"Safety and immunogenicity of the α-synuclein active immunotherapeutic PD01A in patients with Parkinson's disease: a randomised, single-blinded, phase 1 trial.","BACKGROUND


Robust evidence supports the role of α-synuclein pathology as a driver of neuronal dysfunction in Parkinson's disease. PD01A is a specific active immunotherapy with a short peptide formulation targeted against oligomeric α-synuclein. This phase 1 study assessed the safety and tolerability of the PD01A immunotherapeutic in patients with Parkinson's disease.
METHODS


We did a first-in-human, randomised, phase 1 study of immunisations with PD01A, followed by three consecutive study extensions. Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria. Patients were randomly assigned (1:1), using a computer-generated sequence with varying block size, to receive four subcutaneous immunisations with either 15 μg or 75 μg PD01A injected into the upper arms and followed up initially for 52 weeks, followed by a further 39 weeks' follow-up. Patients were then randomly assigned (1:1) again to receive the first booster immunisation at 15 μg or 75 μg and were followed up for 24 weeks. All patients received a second booster immunisation of 75 μg and were followed up for an additional 52 weeks. Patients were masked to dose allocation. Primary (safety) analyses included all treated patients. These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16.
FINDINGS


32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible and randomly assigned to receive four PD01A priming immunisations. One patient had a diagnosis change to multiple system atrophy and was withdrawn and two patients withdrew consent during the studies. 21 (87%) of 24 patients received all six immunisations and completed 221-259 weeks in-study (two patients in the 15 μg dose group and one patient in the 75 μg dose group discontinued). All patients experienced at least one adverse event, but most of them were considered unrelated to study treatment (except for transient local injection site reactions, which affected all but one patient). Serial MRI assessments also ruled out inflammatory processes. Systemic treatment-related adverse events were fatigue (n=4), headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2). The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group. Antibody titres returned to baseline over 2 years, but could be rapidly reactivated after booster immunisation from week 116 onwards, reaching geometric group mean titres up to 1:20218.
INTERPRETATION


Repeated administrations of PD01A were safe and well tolerated over an extended period. Specific active immunotherapy resulted in a substantial humoral immune response with target engagement. Phase 2 studies are needed to further assess the safety and efficacy of PD01A for the treatment of Parkinson's disease.
FUNDING


AFFiRiS, Michael J Fox Foundation.",2020,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[""patients with Parkinson's disease"", ""Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria"", 'These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16', '32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible']","['PD01A', 'PD01A immunotherapeutic', 'α-synuclein active immunotherapeutic PD01A']","['Safety and immunogenicity', 'geometric group mean titre of antibodies against the immunising peptide PD01', 'safety and tolerability', 'headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2', 'Antibody titres', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0165073', 'cui_str': 'Synuclein'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",32.0,0.129353,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[{'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Volc', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kutzelnigg', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lührs', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Thun-Hohenstein', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Schneeberger', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Galabova', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Majbour', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Vaikath', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El-Agnaf', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Dorian', 'Initials': 'D', 'LastName': 'Winter', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mihailovska', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mairhofer', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwenke', 'Affiliation': 'Schwenke Consulting: Strategies and Solutions in Statistics, Berlin, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Staffler', 'Affiliation': 'AFFiRiS, Vienna, Austria. Electronic address: guenther.staffler@affiris.com.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Medori', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30136-8']
1175,32563858,Capitalizing on cross-language similarities in intervention with bilingual children.,"PURPOSE


This study examined the effects of a vocabulary intervention for bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates. We measured effects in terms of change from pre- to post-intervention in Spanish as well as associations with the non-target language, English.
METHOD


Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder. Children completed the intervention in pairs (one child with DLD and a typically developing peer) for 70-minute sessions, 3 days a week, for four weeks. Intervention targeted 32 words (16 cognates, 16 non-cognates) using four storybooks (8 words/book) and interactive activities that highlighted similarities across languages. Pre- and post-intervention measures in Spanish and English included tasks of word definition and cognate facilitation.
RESULTS


As a group, children showed improvement in definition quality and cognate naming in Spanish. There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD. All children showed positive cross-language correlations on post-intervention measures.
CONCLUSIONS


Bilingual children, with and without DLD, have the capacity to improve in their awareness and use of cognates. Explicit teaching of cognates can be an effective tool for building vocabulary skills. Children with DLD may need additional time and support to apply their knowledge of cognates to vocabulary learning.",2020,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[""bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates"", 'Children with DLD', 'Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder', 'Spanish and English']",['vocabulary intervention'],"['included tasks of word definition and cognate facilitation', 'definition quality and cognate naming', 'positive cross-language correlations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0437372,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[{'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Dam', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States; University of California San Diego, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: qdam@sdsu.edu.'}, {'ForeName': 'Giang T', 'Initials': 'GT', 'LastName': 'Pham', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: gpham@sdsu.edu.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Pruitt-Lord', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: spruitt@sdsu.edu.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Limon-Hernandez', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: jlimon-hernandez@sdsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Goodwiler', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: cgoodwiler@sdsu.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106004']
1176,32464280,"Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial.","BACKGROUND


There is a high unmet clinical need for treatments of advanced/metastatic biliary tract cancers after progression on first-line chemotherapy. Regorafenib has demonstrated efficacy in some gastrointestinal tumors that progress on standard therapies.
PATIENTS AND METHODS


REACHIN was a multicenter, double-blind, placebo-controlled, randomized phase II study designed to evaluate the safety and efficacy of regorafenib in patients with nonresectable/metastatic biliary tract cancer that progressed after gemcitabine/platinum chemotherapy. Patients were randomly assigned 1 : 1 to best supportive care plus either regorafenib 160 mg once daily 3 weeks on/1 week off or placebo until progression or unacceptable toxicity. No crossover was allowed. The primary objective was progression-free survival (PFS). Secondary objectives were response rate, overall survival, and translational analysis.
RESULTS


Sixty-six patients with intrahepatic (n = 42), perihilar (n = 6), or extrahepatic (n = 9) cholangiocarcinoma, or gallbladder carcinoma (n = 9) were randomized, 33 to each treatment group (33 per group). At a median follow-up of 24 months, all patients had progressed and six patients were alive. Median treatment duration was 11.0 weeks [95% confidence interval (CI): 6.0-15.9] in the regorafenib group and 6.3 weeks (95% CI: 3.9-7.0) in the placebo group (P = 0.002). Fourteen of 33 patients (42%) in the regorafenib group had a dose reduction. Stable disease rates were 74% (95% CI: 59-90) in the regorafenib group and 34% with placebo (95% CI: 18-51; P = 0.002). Median PFS in the regorafenib group was 3.0 months (95% CI: 2.3-4.9) and 1.5 months (95% CI: 1.2-2.0) in the placebo group (hazard ratio 0.49; 95% CI: 0.29-0.81; P = 0.004) and median overall survival was 5.3 months (95% CI: 2.7-10.5) and 5.1 months (95% CI: 3.0-6.4), respectively (P = 0.28). There were no unexpected/new safety signals.
CONCLUSION


Regorafenib significantly improved PFS and tumor control in patients with previously treated metastatic/unresectable biliary tract cancer in the second- or third-line setting.
CLINICAL TRIAL REGISTRATION


The trial is registered in the European Clinical Trials Register database (EudraCT 2012-005626-30) and at ClinicalTrials.gov (NCT02162914).",2020,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"['advanced/metastatic biliary tract cancers (BTC) after progression on first-line chemotherapy', 'patients with previously treated metastatic/unresectable BTC in the second- or third-line setting', 'locally advanced/metastatic biliary tumors', 'patients with nonresectable/metastatic BTC that progressed after', 'Sixty-six patients with intra-hepatic (n=42), peri-hilar (n=6), or extra-hepatic (n=9) cholangiocarcinoma, or gallbladder carcinoma (n=9']","['regorafenib', 'supportive care plus either regorafenib', 'Regorafenib', 'gemcitabine/platinum chemotherapy', 'gemcitabine and platinum-based chemotherapy', 'placebo']","['PFS and tumor control', 'Median PFS', 'median OS', 'Stable disease rates', 'Median treatment duration', 'safety and efficacy', 'progression-free survival (PFS', 'response rate, overall survival (OS), and translational analysis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0005426', 'cui_str': 'Neoplasm of biliary tract'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0235782', 'cui_str': 'Carcinoma of gallbladder'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",66.0,0.690482,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demols', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: anne.demols@erasme.ulb.ac.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van den Eynde', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Houbiers', 'Affiliation': 'Oncology Department, Saint-Joseph Community Health Center, Liège, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Oncology Department - University Hospital Antwerp, Edegem, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marechal', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delaunoit', 'Affiliation': 'GE Department, INDC Entité Jolimontoise, Haine-St-Paul, Belgium.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Goemine', 'Affiliation': 'Oncology Department, Cliniques et Maternité Ste Elisabeth, Namur, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'GE Department - Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Holbrechts', 'Affiliation': 'Oncology Department, Centre Hospitalier Universitaire A. Paré, Mons, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paesmans', 'Affiliation': 'Data Center, Institut J. Bordet, Brussels, Belgium.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.018']
1177,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION


As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
1178,32472340,Computerized occlusal analysis of Essix and Hawley retainers used during the retention phase: a controlled clinical trial.,"AIM


The aim of this study was to evaluate the occlusal force distribution (OFD), individual tooth force (ITF), and occlusal surface area (OSA) of Essix and Hawley retainers, using T‑Scan III (Tekscan Inc., South Boston, MA, USA) analysis.
MATERIALS AND METHODS


A total of 35 subjects were randomly assigned to one of the retention groups following fixed orthodontic treatment. While 18 of these subjects were provided with Essix retainers, 17 were given Hawley retainers. Computerized occlusal analysis of the patients' dentitions was performed using T‑Scan III. The evaluations were made after debonding (T0) and at month 3 (T1), month 6 (T2) and 1 year (T3) after the retention phase.
RESULTS


The changes in OFD were significant only in the Hawley group for the left/right half jaws and the right posterior quadrants when comparing the T2-T3 time interval. Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals. The changes in ITF were insignificant within groups, but significant between the groups for tooth 11 and 22. Although there was an increase observed in OSA for both groups, the difference between the groups was insignificant. However, the OSA increase in the Essix group for the left/right anterior quadrants was significant only for the T0-T2 and the T0-T3 time intervals, while in both groups, for the posterior left quadrant, the OSA was insignificant only for the T0-T1 time interval.
CONCLUSIONS


Although OSA increased when using both retention appliances, OFD did not change.",2020,"Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals.",['A\xa0total of 35\xa0subjects'],['OSA'],"['changes in OFD', 'OSA increase', 'changes in ITF', 'occlusal force distribution (OFD), individual tooth force (ITF), and occlusal surface area (OSA) of Essix and Hawley retainers, using T‑Scan\xa0III (Tekscan Inc., South Boston, MA, USA) analysis', 'OSA']","[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0329424,"Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals.","[{'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Alkan', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Yüzüncü Yıl University, Van, Turkey. yesimkaya82@hotmail.com.'}, {'ForeName': 'Sıddık', 'Initials': 'S', 'LastName': 'Keskin', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00236-4']
1179,32471657,Effect of Sit-to-Stand Exercises Combined With Protein-Rich Oral Supplementation in Older Persons: The Older Person's Exercise and Nutrition Study.,"OBJECTIVES


Nursing home (NH) residents are often undernourished and physically inactive, which contributes to sarcopenia and frailty. The Older Person's Exercise and Nutrition Study aimed to investigate the effects of sit-to-stand exercises (STS) integrated into daily care, combined with a protein-rich oral nutritional supplement (ONS), on physical function, nutritional status, body composition, health-related quality of life, and resource use.
DESIGN


Residents in 8 NHs were randomized by NH units into an intervention group (IG) or a control group (CG) (n = 60/group). The IG was a combination of STS (4 times/day) and ONS (2 bottles/day providing 600 kcal and 36 g protein) for 12 weeks.
SETTING AND PARTICIPANTS


The participants resided in NH units (dementia and somatic care), were ≥75 years of age, and able to rise from a seated position.
METHODS


The 30-second Chair Stand Test was the primary outcome. Secondary outcomes were balance, walking speed, dependence in activities of daily living, nutritional status and body composition, health-related quality of life, and resource use.
RESULTS


Altogether, 102 residents (age 86 ± 5 years, 62% female) completed the study. No improvement in the physical function assessments was observed in the IG, whereas body weight increased significantly (2.05 ± 3.5 kg, P = .013) vs the CG. Twenty-one (of 52) participants with high adherence to the intervention (ie, at least 40% compliance to the combined intervention) increased their fat free mass (2.12 kg (0.13, 4.26 interquartile range), P = .007 vs CG). Logistic regression analyses indicated that the odds ratio for maintained/improved 30-second Chair Stand Test was 3.5 (confidence interval 1.1, 10.9, P = .034) among the participants with high adherence compared with the CG.
CONCLUSIONS/IMPLICATIONS


Twelve-week intervention of daily STS combined with ONS in NH residents did not improve physical function, but increased body weight. Subgroup analyses indicated that high adherence to the combined intervention was associated with maintained or improved physical function and a gain of fat free mass.",2020,Subgroup analyses indicated that high adherence to the combined intervention was associated with maintained or improved physical function and a gain of fat free mass.,"['102 residents (age 86\xa0±\xa05\xa0years, 62% female) completed the study', 'Residents in 8 NHs', 'Nursing home (NH) residents', 'Older Persons', 'participants resided in NH units (dementia and somatic care), were ≥75\xa0years of age, and able to rise from a seated position']","['control group (CG', 'Sit-to-Stand Exercises Combined With Protein-Rich Oral Supplementation', 'STS', 'sit-to-stand exercises (STS) integrated into daily care, combined with a protein-rich oral nutritional supplement (ONS', 'STS combined with ONS']","['physical function', 'body weight', 'physical function and a gain of fat free mass', 'fat free mass', 'balance, walking speed, dependence in activities of daily living, nutritional status and body composition, health-related quality of life, and resource use', 'odds ratio for maintained/improved 30-second Chair Stand Test', 'physical function assessments', 'physical function, nutritional status, body composition, health-related quality of life, and resource use']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",52.0,0.0601907,Subgroup analyses indicated that high adherence to the combined intervention was associated with maintained or improved physical function and a gain of fat free mass.,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Grönstedt', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Allied Health Professionals, Function Area Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Vikström', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Occupational Therapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Stockholm, Sweden; Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden; Theme Aging, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Franzén', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Allied Health Professionals, Function Area Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvette C', 'Initials': 'YC', 'LastName': 'Luiking', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, the Netherlands.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Seiger', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wimo', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Neurogeriatrics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Faxén-Irving', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden; Allied Health Professionals, Function Area Clinical Nutrition, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boström', 'Affiliation': 'Stockholms Sjukhem R&D Unit, Stockholm, Sweden; Theme Aging, Karolinska University Hospital, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Nursing, Karolinska Institutet, Stockholm, Sweden; Western Norway University of Applied Sciences, Haugesund, Norway. Electronic address: anne-marie.bostrom@ki.se.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.03.030']
1180,32478917,Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis.,"BACKGROUND


Palliative care remains suboptimal in end-stage liver disease.
AIM


To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison.
METHODS


A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion.
RESULTS


Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway.
CONCLUSIONS


The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation.
TRIAL REGISTRATION


ISRCTN30697116, date assigned: 07/10/2015.",2020,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"['59 eligible patients, 36 (61']","['palliative long-term abdominal drains vs large-volume paracentesis', 'large-volume paracentesis vs long-term abdominal drains']","['Total attrition', 'peritonitis incidence', 'serum creatinine', 'Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital', 'Self-limiting cellulitis/leakage', 'median number (IQR) of hospital ascitic drains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441140', 'cui_str': 'Abdominal drain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040227', 'cui_str': 'Time Studies'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439685', 'cui_str': 'Ascitic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]",59.0,0.162379,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macken', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crook', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mason', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Lambert', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Timeyin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Steer', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Austin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parnell', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Thomson', 'Affiliation': 'Worthing, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sheridan', 'Affiliation': 'Plymouth, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Isaacs', 'Affiliation': 'Blackpool, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hashim', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Brighton, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15802']
1181,32475183,Does lopinavir measure up in the treatment of COVID-19?,"INTRODUCTION


Lopinavir in combination with ritonavir is approved for the treatment of HIV and has recently been subject to a clinical trial in severe COVID-19.
AREAS COVERED


This evaluation is of LOTUS China (the Lopinavir Trial for Suppression of SARS-Cov-2 in China), which was a randomized trial in hospitalized subjects with COVID-9 in a respiratory sample and pneumonia. As, in severe COVID-19, lopinavir/ritonavir had no beneficial effects but increased gastrointestinal adverse effects, this combination should not be used at this stage of COVID-19.
EXPERT OPINION


In my opinion, the rationale for undertaking a trial of lopinavir/ritonavir in COVID-19 was poor. The analysis of a modified intention to treat group analysis in LOTUS China may have introduced bias. After LOTUS China, there is probably no future for lopinavir in the treatment of severe COVID-19, but some clinical trials for prevention or in various stages of COVID-19 have recently started or are ongoing. The major limitation of these trials is that as lopinavir does not inhibit COVID-19, it is unlikely to prevent infection, reduce viral load, or reduce the severity. However, these trials may be worthwhile in finally determining whether lopinavir has any role in preventing or treating COVID-19.",2020,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.",['hospitalised subjects with Covid-9 in a respiratory sample and pneumonia'],"['lopinavir', 'ritonavir', 'lopinavir/ritonavir']",['gastrointestinal adverse effects'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444279', 'cui_str': 'Respiratory sample'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.148574,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1777277']
1182,32475360,"Vitamin D 3  reduces risk of cardiovascular and liver diseases by lowering homocysteine levels: double-blinded, randomised, placebo-controlled trial.","The objective of this study was to evaluate the effect of vitamin D3 on total homocysteine (tHcy) and C-reactive protein (CRP) levels and liver and kidney function tests in overweight women with vitamin D deficiency. Therefore, a randomised, double-blind placebo, controlled clinical trial was conducted on 100 eligible women. Subjects were randomly divided into two groups: the placebo (n 50) and the vitamin D (n 50) which received 1250 µg vitamin D3 per week for 2 months. The participants' 25-hydroxyvitamin D (25(OH)D), tHcy, CRP, alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea, creatinine and estimated glomerular filtration rate (eGFR) were measured and compared before and after treatment. Results showed that the tHcy, CRP, AST, ALT and eGFR levels after the 2nd month of vitamin D3 intervention were significantly (P < 0·001) decreased and the 25(OH)D, urea and creatinine levels were significantly (P < 0·001) increased in the treatment group. In the placebo group, no significant changes were identified throughout the follow-up period. In conclusion, vitamin D3 intervention with a treatment dose of 1250 µg/week for at least 2 months may help in lowering Hcy and CRP levels and may improve liver function tests, which in turn might help in minimising the risk of CVD and liver diseases among overweight women but negatively affect kidney function.",2020,"Results showed that the tHcy, CRP, AST, ALT, and eGFR levels after the second month of vitamin D3 intervention were significantly (p < 0.001) decreased and the 25(OH)D, urea, and creatinine levels were significantly (p < 0.001) increased in the treatment group.","['overweight women with vitamin D deficiency', 'one hundred eligible women']","['Vitamin D', 'placebo', 'vitamin D3 intervention', 'vitamin D', 'vitamin D3', '50,000 IU vitamin D3']","['tHcy, CRP, AST, ALT, and eGFR levels', 'risk of cardiovascular and liver diseases', '25(OH)D, urea, and creatinine levels', 'total homocysteine (tHcy) and C-reactive protein (CRP) levels and liver and kidney function tests', 'lowering homocysteine and CRP levels', '25- hydroxyvitamin D (25 (OH)D), tHcy, CRP, aspartate and alanine aminotransferases (AST, ALT), urea, creatinine and estimated glomerular filtration rate (eGFR', 'liver function tests']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}]",100.0,0.469588,"Results showed that the tHcy, CRP, AST, ALT, and eGFR levels after the second month of vitamin D3 intervention were significantly (p < 0.001) decreased and the 25(OH)D, urea, and creatinine levels were significantly (p < 0.001) increased in the treatment group.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Al-Bayyari', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Al-Huson University College, Al-Balqa Applied University, Al-Salt, 19117, Jordan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hailat', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, MI48824, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Subih', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, Irbid, 22110, Jordan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Alkhalidy', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, Irbid, 22110, Jordan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eaton', 'Affiliation': 'Department of Integrated Physiology and Health Sciences, Alma College, Alma, MI48801, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001890']
1183,32487243,Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial.,"BACKGROUND


According to the American Physical Therapy Association, there is strong evidence to show that vertebral mobilization and manipulation procedures can be used to improve spinal and hip mobility and reduce pain and incapacity in low back pain patients that fit the clinical prediction rule.
OBJECTIVES


To evaluate the immediate effects of high-velocity low-amplitude (HVLA) manipulation on pain and postural control parameters in individuals with nonspecific low back pain.
METHODS


This study used a participant-blinded and assessor-blinded randomized controlled clinical trial involving a single session, in which 24 participants were randomly distributed into control (simulated manipulation) and intervention (HVLA lumbar manipulation) groups. The primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity) were evaluated before and after the session using a numerical pain scale, algometer, and a force platform. For all outcomes, multiple mixed 2 (group) × 2 (time) ANOVAs were performed.
RESULTS


For the subjective pain intensity, only time was significant as a main effect, where pre-intervention presented a greater value then post-intervention (F [1.44] = 4.377; p = 0.042; r = 0.30). For the pressure pain threshold no significant effect was found. For the postural control parameters, as a main effect, only the ellipse area was significantly greater in the control group (F [1.44] = 6.760; p = 0.013; effect size = 0.36).
CONCLUSIONS


There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure. No effect of HVLA lumbar manipulation was identified for postural control variables in either the intervention or control groups.
TRIAL REGISTRATION


The study was registered at ClinicalTrials.gov under the number NCT02312778, registered at 14 September 2014.",2020,"There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure.","['low back pain patients', '24 participants were randomly distributed into', 'individuals with nonspecific low back pain']","['high-velocity low-amplitude (HVLA) manipulation', 'HVLA lumbar manipulation', 'lumbar spine manipulation', 'control (simulated manipulation) and intervention (HVLA lumbar manipulation']","['pain sensitivity and postural control', 'pain and postural control parameters', 'subjective pain intensity', 'primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity', 'numerical pain scale, algometer, and a force platform']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0600578', 'cui_str': 'Lumbar Manipulation'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",24.0,0.116324,"There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure.","[{'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Fagundes Loss', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil. jefferson.loss@ufrgs.br.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'de Souza da Silva', 'Affiliation': 'Instituto Brasileiro de Osteopatia, Porto Alegre, Brazil.'}, {'ForeName': 'Iã', 'Initials': 'I', 'LastName': 'Ferreira Miranda', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Groisman', 'Affiliation': 'Instituto Brasileiro de Osteopatia, Porto Alegre, Brazil.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Santiago Wagner Neto', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}, {'ForeName': 'Catiane', 'Initials': 'C', 'LastName': 'Souza', 'Affiliation': 'Faculdade Social da Bahia, Salvador, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Tarragô Candotti', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00316-7']
1184,32490642,Baseline characteristics predicting clinical outcomes and serious adverse events in middle-aged hypertensive women: a subanalysis of the SPRINT in women aged <65 years,"Background/aim


The predictability of clinical outcomes in hypertension in specific patient groups, especially underrepresented populations is the key to rational treatment. This study aimed to investigate the impact of baseline characteristics of <65-year-old hypertensive women with an increased risk of cardiovascular events, managed with standard- or intensive-approach, on their clinical outcomes and serious adverse events (SAEs).
Materials and methods


Baseline characteristics of <65-year-old hypertensive women (n = 1247) in SPRINT, a multicenter randomized trial to compare standard and intensive antihypertensive treatment, were analyzed with Cox-regression method to determine potential predictors of the clinical outcomes and SAEs. The primary outcome was the composite of myocardial infarction (MI), non-MI acute coronary syndrome, stroke, heart failure, or cardiovascular death.
Results


The primary outcome occurred in 3.1% and SAEs in 27.6% of the population. The treatment groups were similar in terms of the primary outcome, SAEs, or their individual components. The primary outcome occurred significantly more in current smokers vs. nonsmokers (HR: 2.85, 95% CI: 1.34–6.09). The subjects who were on aspirin in the intensive-group were significantly more likely to develop the primary outcome (HR: 3.17, 95% CI: 1.23-8.19) and MI (HR: 10.15, 95% CI: 1.19-86.88) compared with those not using aspirin. The risk of overall SAEs was significantly higher in blacks vs. nonblacks (HR: 1.27, 95% CI: 1.01-1.58), in current-smokers vs. nonsmokers (HR: 1.59, 95% CI: 1.23-2.05), and those with vs. without chronic kidney disease (CKD), (HR: 1.38, 95% CI: 1.08-1.77). The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
Conclusion


Smoking, aspirin, CKD, black race, and age seemed as important baseline characteristics in follow-up of <65-year-old hypertensive women, also depending on therapeutic strategy. Clinicians are expected to consider these critical parameters for effective antihypertensive management that promotes better outcomes in this middle-aged female population.",2020,"The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
","['65-year-old hypertensive women with an increased risk of cardiovascular events, managed with standard- or intensive-approach', 'middle-aged hypertensive women', 'women aged <65 years', '65-year-old hypertensive women', 'Baseline characteristics of <65-year-old hypertensive women ', 'middle-aged female population']",['aspirin'],"['SAEs, or their individual components', 'risk of overall SAEs', 'composite of myocardial infarction (MI), non-MI acute coronary syndrome, stroke, heart failure, or cardiovascular death', 'current-smokers vs. non-smokers', 'likelihood of SAEs']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.264691,"The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
","[{'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Aydin', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Akici', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Sakarya', 'Affiliation': 'Department of Public Health, School of Medicine, Koç University, İstanbul, Turkey'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Akman', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}, {'ForeName': 'Ali Serdar', 'Initials': 'AS', 'LastName': 'Fak', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}]",Turkish journal of medical sciences,['10.3906/sag-1907-144']
1185,32485641,"Caloric restriction, resting metabolic rate and cognitive performance in Non-obese adults: A post-hoc analysis from CALERIE study.","Physical activity (PA) has been proposed as a determinant of cognitive function and is one component of energy balance (EB). EB is the difference between energy intake (EI) and the total daily energy expenditure (TDEE). TDEE is a combination of resting metabolic rate (RMR), thermic effect of food and PA. The potential role of each of these components on cognitive function has not yet been systemically investigated. We aim to evaluate the association between each component of EB on cognition, using baseline and longitudinal data from a clinical trial of caloric restriction (CR). This is a parallel-group, randomized clinical trial comparing two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI ≥ 22 kg/m2 and <28 kg/m2. Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content were evaluated, as well as RMR, TDEE, cognitive performance and baseline energy intake. A 30 min/day of a moderate level on a minimum of 5 days/week was advised as PA measure. Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass. EB and homeostasis are crucial to modulate the RMR. Moreover, RMR presents an important influence on cognitive function in individuals submitted to CR in a long term.",2020,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","['two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI', 'Non-obese adults']","['TDEE', 'Physical activity (PA', 'caloric restriction (CR']","['cognitive performance', 'RMR, TDEE, cognitive performance and baseline energy intake', 'total daily energy expenditure (TDEE', 'cognitive function', 'resting metabolic rate (RMR), thermic effect of food and PA', 'Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content', 'cognitive performance and the RMR', 'Caloric restriction, resting metabolic rate and cognitive performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]",220.0,0.044031,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","[{'ForeName': 'Ruth Bartelli', 'Initials': 'RB', 'LastName': 'Grigolon', 'Affiliation': 'Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil; Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada; Centre for Neuroscience Studies (CNS), Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Alisson Paulino', 'Initials': 'AP', 'LastName': 'Trevizol', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada; Brain and Cognition Foundation, Toronto, ON, Canada.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada. Electronic address: rodrigomansur71@uol.com.br.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.018']
1186,32589148,Web-Based Health Coaching for Spinal Cord Injury: Results From a Mixed Methods Feasibility Evaluation.,"BACKGROUND


Individuals with spinal cord injury (SCI) are at high risk of experiencing secondary conditions like pressure injuries. Self-management programs may reduce the risk of complications, but traditional programs have proven to be insufficiently tailored to the needs of people with SCI. To overcome barriers to self-management support, a web-based, self-management program was developed for Canadians with SCI called SCI & U.
OBJECTIVE


This study aims to evaluate the feasibility and potential impact of the SCI & U program in the context of a mixed methods pilot study.
METHODS


The study followed an explanatory, sequential mixed methods design. Participants (N=11) were Canadians with SCI who had been living in the community for more than 1 year. Each took part in a self-paced, six-session self-management program guided by a trained peer health coach. During sessions, participants could discuss a health topic with their coach from a predefined list (eg, skin or bowel management). Quantitative data were gathered before and after program participation to assess program feasibility and impact. Feasibility measures included attrition rates, frequency of topics selected, and recorded goals, whereas impact measures included measures of self-efficacy (University of Washington Self-Efficacy Scale [UW-SES]), mood (Personal Health Questionnaire Depression Scale [PHQ-8]), secondary conditions (Spinal Cord Injury Secondary Conditions Scale [SCI-SCS]), and resilience (Spinal Cord Injury Quality of Life Resilience Scale [SCI-QOL-R]). Qualitative measures were based on postintervention interviews; these were designed to confirm and expand on quantitative.
RESULTS


Of the 11 participants, 10 completed pre- and postassessments, and 6 coaching sessions. Sessions lasted between 31 and 81 min (average 55, SD 13), and the duration of the program ranged from 35 to 88 days (average 56, SD 23). Diet and exercise were selected as topics 40% (20/50 sessions with topics) of the time, whereas topics such as mental health, bladder management, pain, and bowel management were chosen less frequently. Results gathered before and after the pilot study demonstrated improvements with moderate effect sizes on the UW-SES and the electronic health literacy scale (ie, Hedges g>0.5). Effect sizes for measures of resilience (SCI-QOL-R), depression (PHQ-8), and secondary conditions (SCI-SCS) were small (ie, Hedges g>0.3). Qualitative results confirmed a common focus on diet and exercise, and defined coaches as sources of accountability, information, reassurance and affirmation, and emotional and technical support.
CONCLUSIONS


Results demonstrated that a web-based self-management program is feasible and acceptable by Canadians with SCI. Results also indicated a web-based, peer-led self-management program may impact resilience, self-efficacy, mood, and secondary complications. Finally, results illuminated the role of the coach in facilitating behavior change. Future work seeks to validate results in the context of a randomized controlled trial.",2020,Pre- and post results demonstrated improvements with moderate effect sizes on the UW-SES and eHEALS,"['Spinal Cord Injury', 'Individuals with spinal cord injury (SCI', 'Participants (N=11) were Canadians with SCI who had been living in the community for more than 1 year']","['Online Health Coaching', 'SCI&U"" program']","['resilience (SCI-QOL-R), depression (PHQ-8) and secondary conditions (SCI-SCS', 'impact resilience, self-efficacy, mood and secondary complications', 'attrition rates, frequency of health topics selected and recorded goals, while impact measures included measures of self-efficacy (UW-SES), mood (PHQ-8), secondary conditions (SCI-SCS) and resilience (SCI-QOL-R', 'UW-SES and eHEALS']","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",11.0,0.0375081,Pre- and post results demonstrated improvements with moderate effect sizes on the UW-SES and eHEALS,"[{'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Allin', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shepherd', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Thorson', 'Affiliation': 'Spinal Cord Injury BC, Vancouver, BC, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tomasone', 'Affiliation': 'School of Kinesiology and Health Studies, Queens University, Kingston, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Munce', 'Affiliation': 'Toronto Rehabilitation Institute, Toronto, ON, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Linassi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'McBride', 'Affiliation': 'Spinal Cord Injury BC, Vancouver, BC, Canada.'}, {'ForeName': 'Tizneem', 'Initials': 'T', 'LastName': 'Jiancaro', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jaglal', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, ON, Canada.'}]",JMIR rehabilitation and assistive technologies,['10.2196/16351']
1187,32590385,Mechanical Ventilation Strategy Guided by Transpulmonary Pressure in Severe Acute Respiratory Distress Syndrome Treated With Venovenous Extracorporeal Membrane Oxygenation.,"OBJECTIVES


Previous studies have suggested that adjusting ventilator settings based on transpulmonary pressure measurements may minimize ventilator-induced lung injury, but this has never been investigated in patients with severe acute respiratory distress syndrome supported with venovenous extracorporeal membrane oxygenation. We aimed to evaluate whether a transpulmonary pressure-guided ventilation strategy would increase the proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation support in patients with severe acute respiratory distress syndrome.
DESIGN


Single-center, prospective, randomized controlled trial.
SETTING


Sixteen-bed, respiratory ICU at a tertiary academic medical center.
PATIENTS


Severe acute respiratory distress syndrome patients receiving venovenous extracorporeal membrane oxygenation.
INTERVENTIONS


One-hundred four patients were randomized to transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group (n = 52) groups. Two patients had cardiac arrest during establishment of venovenous extracorporeal membrane oxygenation in the lung rest group did not receive the assigned intervention. Thus, 102 patients were included in the analysis.
MEASUREMENTS AND MAIN RESULTS


The proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation in the transpulmonary pressure-guided group was significantly higher than that in the lung rest group (71.2% vs 48.0%; p = 0.017). Compared with the lung rest group, driving pressure, tidal volumes, and mechanical power were significantly lower, and positive end-expiratory pressure was significantly higher, in the transpulmonary pressure-guided group during venovenous extracorporeal membrane oxygenation support. In the transpulmonary pressure-guided group, levels of interleukin-1β, interleukin-6, and interleukin-8 were significantly lower, and interleukin-10 was significantly higher, than those of the lung rest group over time. Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
CONCLUSIONS


A transpulmonary pressure-guided ventilation strategy could increase the proportion of patients with severe acute respiratory distress syndrome successfully weaned from venovenous extracorporeal membrane oxygenation.",2020,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
","['102 patients were included in the analysis', 'Severe Acute Respiratory Distress Syndrome Treated With', 'Severe acute respiratory distress syndrome patients receiving', 'Sixteen-bed, respiratory ICU at a tertiary academic medical center', 'patients with severe acute respiratory distress syndrome', 'One-hundred four patients']","['transpulmonary pressure-guided ventilation strategy', 'venovenous extracorporeal membrane oxygenation', 'Mechanical Ventilation Strategy Guided by Transpulmonary Pressure', 'transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group', 'Venovenous Extracorporeal Membrane Oxygenation', 'venovenous extracorporeal membrane oxygenation support']","['proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation', 'driving pressure, tidal volumes, and mechanical power', 'cardiac arrest', 'Lung density', 'positive end-expiratory pressure', 'levels of interleukin-1β, interleukin-6, and interleukin-8']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",104.0,0.101497,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'All authors: Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Xuyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Hangyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Haichao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004445']
1188,32591170,"Targeting Cognitive Control Deficits With Neuroplasticity-Based Computerized Cognitive Remediation in Patients With Geriatric Major Depression: A Randomized, Double-Blind, Controlled Trial.","Late life major depression (LLD) is often accompanied by cognitive deficits. When patients have specific deficits in cognitive control functions (CCD), they are not only distressing and debilitating, they often predict poor clinical outcomes such as reduced response to SSRI/SNRI antidepressants, increased disability, suicide and all-cause mortality. We recently reported that in an open label trial, our treatment designed to target these specific CCD with neuroplasticity-based computerized cognitive remediation (nCCR) improved depression and CCD in patients who failed to remit with conventional antidepressant treatment. This study tested the hypothesis that in patients with LLD who have failed at least one trial of an SSRI/SNRI antidepressant at an adequate dose for at least 8 weeks, nCCR will improve both depressive symptoms and the CCD associated with poor antidepressant response (i.e. semantic strategy, inhibition of prepotent responses) more than an active control group. Participants were randomized (1:1) to receive either 30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff. All participants and raters were blinded. Mixed effects model analysis the time effect (week) (F(1,71.22)=25.2, p<0.0001) and treatment group X time interaction (F(1,61.8)=11.37, p=.002) reached significance indicating that the slope of decline in MADRS was steeper in the nCCR-GD group. Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B). Further, results transferred to memory performance, which was not a function trained by nCCR. clinicaltrials.gov.",2020,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","['With Geriatric Major Depression', 'patients who failed to remit with conventional antidepressant treatment', 'patients with LLD who have failed at least one trial of an', 'Patients']","['neuroplasticity-based computerized cognitive remediation (nCCR', '30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff', 'Neuroplasticity-Based Computerized Cognitive Remediation', 'SSRI/SNRI antidepressant']","['Stroop interference condition, and cognitive flexibility (Trails B', 'MADRS', 'Late life major depression (LLD']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008928', 'cui_str': 'Cleidocranial dysostosis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}]","[{'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.145174,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","[{'ForeName': 'Sarah Shizuko', 'Initials': 'SS', 'LastName': 'Morimoto', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT. Electronic address: sarah.morimoto@hsc.utah.edu.'}, {'ForeName': 'Roger Alan', 'Initials': 'RA', 'LastName': 'Altizer', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Therapeutic Games and Apps Lab, Department of Entertainment Arts and Engineering, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Zhongda Hospital, Medical School of Southeast University, Nanjing, China.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cote', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Nitis', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.023']
1189,32592776,"Highly accurate artificial intelligence systems to predict the invasion depth of gastric cancer: efficacy of conventional white-light imaging, nonmagnifying narrow-band imaging, and indigo-carmine dye contrast imaging.","BACKGROUND AND AIMS


Diagnosing the invasion depth of gastric cancer (GC) is necessary to determine the optimal method of treatment. Although the efficacy of evaluating macroscopic features and EUS has been reported, there is a need for more accurate and objective methods. The primary aim of this study was to test the efficacy of novel artificial intelligence (AI) systems in predicting the invasion depth of GC.
METHODS


A total of 16,557 images from 1084 cases of GC for which endoscopic resection or surgery was performed between January 2013 and June 2019 were extracted. Cases were randomly assigned to training and test datasets at a ratio of 4:1. Through transfer learning leveraging a convolutional neural network architecture, ResNet50, 3 independent AI systems were developed. Each system was trained to predict the invasion depth of GC using conventional white-light imaging (WLI), nonmagnifying narrow-band imaging (NBI), and indigo-carmine dye contrast imaging (Indigo).
RESULTS


The area under the curve of the WLI AI system was .9590. The lesion-based sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the WLI AI system were 84.4%, 99.4%, 94.5%, 98.5%, and 92.9%, respectively. The lesion-based accuracies of the WLI, NBI, and Indigo AI systems were 94.5%, 94.3%, and 95.5%, respectively, with no significant difference.
CONCLUSIONS


These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy. The lesion-based accuracy of the WLI, NBI, and Indigo AI systems was not significantly different.",2020,These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy.,['A total of 16557 images from 1084 cases of GC for which endoscopic resection or surgery was performed between January 2013 and June 2019 were extracted'],"['GC using conventional white-light imaging (WLI), nonmagnifying narrow-band imaging (NBI) and indigo-carmine dye contrast imaging (Indigo), respectively', 'novel artificial intelligence systems', 'conventional white-light imaging, nonmagnifying narrow-band imaging, and indigo-carmine dye contrast imaging']","['lesion-based accuracy of the WLI, NBI, and Indigo AI systems', 'lesion-based sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the WLI AI system']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",16557.0,0.0451834,These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy.,"[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Nagao', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Minatsuki', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Niimi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroharu', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Nobutake', 'Initials': 'N', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Seto', 'Affiliation': 'Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Tada', 'Affiliation': 'Department of Surgical Oncology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; AI Medical Service Inc, Tokyo, Japan; Tada Tomohiro Institute of Gastroenterology and Proctology, Saitama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Koike', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.047']
1190,32592897,In-Hospital Management of Sleep Apnea During Heart Failure Hospitalization: A Randomized Controlled Trial.,"BACKGROUND


Obstructive sleep apnea (OSA) is associated with increased mortality and readmissions in patients with heart failure (HF). The effect of in-hospital diagnosis and treatment of OSA during decompensated HF episodes remains unknown.
METHODS AND RESULTS


A single-site, randomized, controlled trial of hospitalized patients with decompensated HF (n = 150) who were diagnosed with OSA during the hospitalization was undertaken. All participants received guideline-directed therapy for HF decompensation. Participants were randomized to an intervention arm which received positive airway pressure (PAP) therapy during the hospitalization (n = 75) and a control arm (n = 75). The primary outcome was discharge left ventricular ejection fraction (LVEF). The LVEF changed in the PAP arm from 25.5 ± 10.4 at baseline to 27.3 ± 11.9 at discharge. In the control group, LVEF was 27.3 ± 11.7 at baseline and 28.8 ± 10.5 at conclusion. There was no significant effect on LVEF of in-hospital PAP compared with controls (P = .84) in the intention-to-treat analysis. The on-treatment analysis in the intervention arm showed a significant increase in LVEF in participants who used PAP for ≥3 hours per night (n = 36, 48%) compared with those who used it less (P = .01). There was a dose effect with higher hours of use associated with more improvement in LVEF. Follow-up of readmissions at 6 months after discharge revealed a >60% decrease in readmissions for patients who used PAP ≥3 h/night compared with those who used it <3 h/night (P < .02) and compared with controls (P < .04).
CONCLUSIONS


In-hospital treatment with PAP was safe but did not significantly improve discharge LVEF in patients with decompensated HF and newly diagnosed OSA. An exploratory analysis showed that adequate use of PAP was associated with higher discharge LVEF and decreased 6 months readmissions.",2020,There was no significant effect on LVEF of in-hospital PAP compared to control (p = 0.84) in the intention to treat analysis.,"['hospitalized patients with decompensated HF (n=150) who were diagnosed with OSA during the hospitalization', 'patients with decompensated HF and newly diagnosed OSA', 'patients with heart failure (HF', 'Obstructive sleep apnea (OSA']","['positive airway pressure (PAP) therapy', 'LVEF', 'guideline directed therapy', 'OSA']","['LVEF', 'discharge LVEF', 'discharge left ventricular ejection fraction (LVEF', 'readmissions', 'LVEF of in-hospital PAP']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.0782909,There was no significant effect on LVEF of in-hospital PAP compared to control (p = 0.84) in the intention to treat analysis.,"[{'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Khayat', 'Affiliation': 'The UCI Sleep Disorders Center and the Division of Pulmonary and Critical Care, University of California at Irvine, Irvine, California; The Sleep Heart Program at the Ohio State University, Columbus, Ohio. Electronic address: rnkhayat@gmail.com.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': 'Bethesda North Hospital, Cincinnati, Ohio; Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio; University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Porter', 'Affiliation': 'The Center for Biostatistics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sow', 'Affiliation': 'The Sleep Heart Program at the Ohio State University, Columbus, Ohio; The Center for Clinical and Translational Science, The Ohio State University Columbus, Ohio.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Holt', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Randerath', 'Affiliation': 'Bethanien Hospital, Institute of Pneumology at the University of Cologne, Solingen, Germany.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jarjoura', 'Affiliation': 'The Sleep Heart Program at the Ohio State University, Columbus, Ohio; Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio; The Center for Biostatistics, The Ohio State University, Columbus, Ohio.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.06.007']
1191,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
1192,32555582,Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial.,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",2020,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",[],[],[],[],[],[],,0.264659,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Bessette', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Jacobs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Heleniak', 'Affiliation': 'Department of Psychology, Columbia University, New York City, NY, United States of America.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Department of Psychiatry, University of Utah, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Watkins', 'Affiliation': 'Mood Disorders Centre, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}]",PloS one,['10.1371/journal.pone.0233539']
1193,32683390,"Efficacy of a topical gel containing chitosan, chlorhexidine, allantoin and dexpanthenol for pain and inflammation control after third molar surgery: A randomized and placebo-controlled clinical trial.","BACKGROUND


The aim of this study was to evaluate and compare the postoperative effect of a topic gel containing chlorhexidine, chitosan, allantoine and dexpanthenol versus a placebo for pain and inflammation control after third molar surgery.
MATERIAL AND METHODS


A gel combining 0.2% chlorhexdine, 0.5% chitosan, 5% dexpanthenol, 0.15% allantoin and 0.01% sodium saccharin was selected for this split mouth randomized controlled and double-blind trial including 36 patients with bilaterally and symmetrically impacted lower third molars. The teeth (n=72) were randomly divided into two groups before surgical removal: control group (CG; in which a placebo was given) and experimental group (EG). Swelling, trismus, postoperative pain, wound healing and complications were measured and recorded in order to evaluate differences between the placebo and experimental product.
RESULTS


Five patients suffered from an alveolitis in the CG (13.9%), and none in the study group (0%), but no statistically significant difference was found (p=0.063). From day 0 to day 7, trismus and swelling were significantly less pronounced in the EG, and wound healing was considered 'good' in 22.2% for the CG and 97.2% for the EG (p<0.001). Mean VAS scores during the seven postoperative days were statistically lower in the study (2.56±1,19) compared to the placebo group (3.25±1.6) (p=0.002). The mean consumption of analgesic pills during the first 92 hours was also statistically lower in the EG (0.26±0.51) in comparison to the CG (0.56±0.67) (p=0.003).
CONCLUSIONS


The use of an experimental gel containing chlorhexidine, chitosan, allantoine and dexpanthenol seems to significantly reduce postoperative pain, trismus and signs of inflammation. Future studies should further evaluate, if the gel is effective in dry socket preventing after third molar removal.",2020,"From day 0 to day 7, trismus and swelling were significantly less pronounced in the EG, and wound healing was considered 'good' in 22.2% for the CG and 97.2% for the EG (p<0.001).","['36 patients with bilaterally and symmetrically impacted lower third molars', 'pain and inflammation control after third molar surgery', 'The teeth (n=72']","['topical gel containing chitosan, chlorhexidine, allantoin and dexpanthenol', 'placebo', 'surgical removal: control group (CG; in which a placebo', 'gel combining 0.2% chlorhexdine, 0.5% chitosan, 5% dexpanthenol, 0.15% allantoin and 0.01% sodium saccharin', 'chlorhexidine, chitosan, allantoine and dexpanthenol']","['trismus and swelling', 'mean consumption of analgesic pills', 'wound healing', 'Mean VAS scores', 'Swelling, trismus, postoperative pain, wound healing and complications', 'postoperative pain, trismus and signs of inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C1160728', 'cui_str': 'Cutaneous gel'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0057610', 'cui_str': 'dexpanthenol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0917900', 'cui_str': 'Saccharin sodium'}]","[{'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",36.0,0.206127,"From day 0 to day 7, trismus and swelling were significantly less pronounced in the EG, and wound healing was considered 'good' in 22.2% for the CG and 97.2% for the EG (p<0.001).","[{'ForeName': 'L-M', 'Initials': 'LM', 'LastName': 'Sáez-Alcaide', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Molinero-Mourelle', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Serrano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rubio-Alonso', 'Affiliation': ''}, {'ForeName': 'M-M', 'Initials': 'MM', 'LastName': 'Bornstein', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'López-Quiles', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23661']
1194,32561468,Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.,"Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289.",2020,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","['Posttraumatic stress disorder (PTSD', 'PTSD among veterans with']","['Prolonged Exposure (PE) therapy', 'oxytocin', 'oxytocin (vs. placebo) administration combined with PE therapy', 'Intranasal oxytocin', 'placebo']","['PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.421747,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: jennifer.mitchell@ucsf.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bakern@musc.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: josh.woolley@ucsf.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Wangelin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bethany.wangelin@va.gov.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: john.mcquaid@va.gov.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: thomas.neylan@ucsf.edu.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: william.wolfe@ucsf.edu.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradykt@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106074']
1195,32562650,"Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis.","BACKGROUND


Trials of intermittent preventive treatment (IPTp) of malaria in pregnant women that compared dihydroartemisinin-piperaquine with the standard of care, sulfadoxine-pyrimethamine, showed dihydroartemisinin-piperaquine was superior at preventing malaria infection, but not at improving birthweight. We aimed to assess whether sulfadoxine-pyrimethamine shows greater non-malarial benefits for birth outcomes than does dihydroartemisinin-piperaquine, and whether dihydroartemisinin-piperaquine shows greater antimalarial benefits for birth outcomes than does sulfadoxine-pyrimethamine.
METHODS


We defined treatment as random assignment to sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine before pooling individual participant-level data from 1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811). We quantified the relative effect of treatment on birthweight (primary outcome) attributed to preventing placental malaria infection (mediator). We estimated antimalarial (indirect) and non-malarial (direct) effects of IPTp on birth outcomes using causal mediation analyses, accounting for confounders. We used two-stage individual participant data meta-analyses to calculate pooled-effect sizes.
FINDINGS


Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69 g, 95% CI 26 to 112), despite placental malaria infection being lower in the dihydroartemisinin-piperaquine group (relative risk [RR] 0·64, 95% CI 0·39 to 1·04). Mediation analyses showed sulfadoxine-pyrimethamine conferred a greater non-malarial effect than did dihydroartemisinin-piperaquine (mean difference 87 g, 95% CI 43 to 131), whereas dihydroartemisinin-piperaquine conferred a slightly larger antimalarial effect than did sulfadoxine-pyrimethamine (8 g, -9 to 26), although more frequent dosing increased the antimalarial effect (31 g, 3 to 60).
INTERPRETATION


IPTp with sulfadoxine-pyrimethamine appears to have potent non-malarial effects on birthweight. Further research is needed to evaluate monthly dihydroartemisinin-piperaquine with sulfadoxine-pyrimethamine (or another compound with non-malarial effects) to achieve greater protection against malarial and non-malarial causes of low birthweight.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bill & Melinda Gates Foundation, and Worldwide Antimalarial Resistance Network.",2020,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","['pregnant women that compared dihydroartemisinin-piperaquine with the standard of care', '1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811']","['sulfadoxine-pyrimethamine', 'sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine', 'IPTp']","['placental malaria infection (mediator', 'antimalarial effect', 'Overall, birthweight', 'placental malaria infection']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",1617.0,0.206058,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","[{'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Roh', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA. Electronic address: michelle.roh@ucsf.edu.'}, {'ForeName': 'Feiko O Ter', 'Initials': 'FOT', 'LastName': 'Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Rerolle', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'M Maria', 'Initials': 'MM', 'LastName': 'Glymour', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Shiboski', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Ianziva"", 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Chico', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30119-4']
1196,32563179,The effects of the iPlayClean education programme on doping attitudes and susceptibility to use banned substances among high-level adolescent athletes from the UK: A cluster-randomised controlled trial.,"Background This study examined the effects of the iPlayClean anti-doping intervention on attitudes towards doping and susceptibility, and whether delivery mode affected the results. Methods A total of 1081 high-level UK athletes (14-18 years old, 904 males, 177 females) were cluster-randomised to the control (11 teams/organisations/schools, 314 athletes), face-to-face group presentation (8 teams/organisations/schools, 254 athletes), online (11 teams/organisations/schools, 251 athletes), or face-to-face presentation with online access (5 teams/organisations/schools, 262 athletes). Results Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later. All delivery modes impacted doping susceptibility immediately after the intervention, in comparison to the control group, but the effects were only sustained for the face-to-face presentation group. Conclusion Contrary to findings within previous anti-doping interventions, we have shown that doping attitudes can be changed and that the results can be sustained across all modes of delivery, 8 weeks later. Research is required to assess for how long these changes are sustained, and how often anti-doping education should be delivered to high-level athletes to reinforce clean play values.",2020,"Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later.","['1081 high-level UK athletes (14-18 years old, 904 males, 177 females) were cluster-randomised to the control (11 teams/organisations/schools, 314 athletes), face-to-face group presentation (8 teams/organisations/schools, 254 athletes), online (11 teams/organisations/schools, 251 athletes), or face-to-face presentation with online access (5 teams/organisations/schools, 262 athletes', 'high-level adolescent athletes from the UK']","['iPlayClean anti-doping intervention', 'iPlayClean education programme']",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0233269', 'cui_str': 'Face presentation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]",[],1081.0,0.0185148,"Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Nicholls', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK. Electronic address: A.Nicholls@hull.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morley', 'Affiliation': 'Department of Dietetics, Nutrition, and Sport, La Trobe University, Melbourne 3086 VIC, Australia.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Hull York Medical School, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Abt', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Rothwell', 'Affiliation': 'Academy of Sport and Physical Activity, Sheffield Hallam University, Howard St, Sheffield S1 1WB, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cope', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Espinal Way, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-Being Research Group,(,) School of Psychology, Curtin University, Kent St, Bentley, WA 6102, Australia.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102820']
1197,32565067,Smartphone-Based Therapeutic Exercises for Men Affected by Premature Ejaculation: A Pilot Study.,"INTRODUCTION


Smartphone-delivered healthcare interventions allow patients to access services on demand when needed, improving motivation and compliance. However, the use of mobile health apps has been scarcely explored in sexual medicine.
AIM


To evaluate the effects of integrating psychological treatment for premature ejaculation (PE) with a mobile coaching app that offers therapeutic exercises on the patient's smartphone.
METHODS


This study comprised 35 heterosexual men with primary psychogenic PE (mean age 34 years, standard deviation = 9.15). All patients entered a cycle of 15 sessions of psychodynamic psychotherapy integrating behavioral therapy, each lasting about 45 minutes. The patients were randomly assigned to 2 groups, each of which performed daily homework exercises (physiotherapy exercises for reinforcing the pelvic floor muscles and cognitive exercises for distancing from sexual failure.) The first group (15 patients) received verbal and printed instructions only (treatment as usual-TAU), whereas the second group (17 patients) experienced the exercises with guidance from the mobile app (app). In both groups, the exercises started after the seventh session. Patients were advised to perform the exercises 3 times a day for 3 months.
MAIN OUTCOME MEASURES


The primary outcome measures were the Premature Ejaculation Diagnostic Tool and the Premature Ejaculation Profile.
RESULTS


Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01). The frequency of patients with no-PE condition for the app group after treatment was significantly higher than the frequency of patients with no-PE condition for the TAU group (P < .001).
CONCLUSION


Results suggest that a mobile coaching app performs better than TAU in improving both the behavioral skills of ejaculatory delay and sexual self-confidence within a psychological treatment for PE. Future studies should collect follow-up data and explore the potential of mobile coaching apps in combined pharmacotherapy and psychotherapy interventions. Optale G, Burigat S, Chittaro L. et al. Smartphone-Based Therapeutic Exercises for Men Affected by Premature Ejaculation: A Pilot Study. J Sex Med 2020;8:461-471.",2020,"RESULTS


Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01).","['35 heterosexual men with primary psychogenic PE (mean age 34 years, standard deviation\xa0=\xa09.15', 'premature ejaculation (PE', 'Men Affected by Premature Ejaculation']","['integrating psychological treatment', 'Smartphone-Based Therapeutic Exercises', 'TAU', 'verbal and printed instructions only (treatment as usual-TAU', 'exercises with guidance from the mobile app (app', 'homework exercises (physiotherapy exercises for reinforcing the pelvic floor muscles and cognitive exercises for distancing from sexual failure', 'psychodynamic psychotherapy integrating behavioral therapy', 'Smartphone-delivered healthcare interventions']","['behavioral skills of ejaculatory delay and sexual self-confidence', 'Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores', 'frequency of patients with no-PE condition', 'Premature Ejaculation Diagnostic Tool and the Premature Ejaculation Profile']","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0458006', 'cui_str': 'Psychogenic'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",35.0,0.0387204,"RESULTS


Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Optale', 'Affiliation': 'Male and Female Sexual Dysfunctions Center of the Regione Veneto, ASL3, Mestre-Venezia, Italy. Electronic address: optale.gabriele@gmail.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Burigat', 'Affiliation': 'HCI Lab, Department of Mathematics, Computer Science, and Physics, Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Chittaro', 'Affiliation': 'HCI Lab, Department of Mathematics, Computer Science, and Physics, Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Riva', 'Affiliation': 'Applied Technology for Neuro-Psychology Lab, IRCCS Istituto Auxologico Italiano, Milan, Italy; Department of Psychology, Università Cattolica del Sacro Cuore, Milan, Italy.'}]",Sexual medicine,['10.1016/j.esxm.2020.05.003']
1198,32573365,Evaluation of an Adapted Collaborative Care Model for Older Adult Depression Severity Reduction and Quality of Life Improvement.,"PURPOSE


The purpose of this clinical study was to evaluate the efficacy of a collaborative care model in the reduction of depression severity and the improvement of quality of life (QOL) of older adults.
METHODS


Individual participant encounters were conducted approximately every 2 weeks over 4 months with nineteen participants. Average participant age was 73 years. A pre-experimental single pretest-posttest group was conducted in which the Patient Health Questionnaire 9 (PHQ-9) and Quality of Life Assessment (QOLA) scores respectively measured depression severity and QOL of participants.
RESULTS


The average PHQ-9 score (0-27; higher indicates worse depression) decreased from 14 pre-intervention to 8.3 post-intervention ( p  < .001), while the average QOLA score (0-10; higher indicates better QOL) increased from 5.7 pre-intervention to 6.5 post-intervention ( p  = .342).
CONCLUSION


The adapted collaborative care model provided an affordable, effective method of older adult depression management within the contexts of this clinical study.",2020,"The adapted collaborative care model provided an affordable, effective method of older adult depression management within the contexts of this clinical study.","['Individual participant encounters were conducted approximately every 2\xa0weeks over 4\xa0months with nineteen participants', 'older adults', 'Average participant age was 73\xa0years']",['collaborative care model'],"['Older Adult Depression Severity Reduction and Quality of Life Improvement', 'QOL', 'quality of life (QOL', 'worse depression', 'average PHQ-9 score', 'Patient Health Questionnaire 9 (PHQ-9) and Quality of Life Assessment (QOLA) scores respectively measured depression severity and QOL of participants', 'average QOLA score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0319654,"The adapted collaborative care model provided an affordable, effective method of older adult depression management within the contexts of this clinical study.","[{'ForeName': 'Victor Ross', 'Initials': 'VR', 'LastName': 'Bench', 'Affiliation': 'Department of Acute & Tertiary Care, University of Pittsburgh, School of Nursing , Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beach', 'Affiliation': 'Department of Acute & Tertiary Care, University of Pittsburgh, School of Nursing , Pittsburgh, PA, USA.'}, {'ForeName': 'Dianxu', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': 'Department of Health & Community Systems, University of Pittsburgh, School of Nursing , Pittsburgh, PA, USA.'}]",Journal of evidence-based social work (2019),['10.1080/26408066.2020.1768193']
1199,32569757,"A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment.","Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a ""coverage with evidence"" trial. This study, entitled, A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees. Predetermined interim analyses will define the necessary sample size. All participants will be implanted with VNS devices: half receive active stimulation during year one, and half receive delayed stimulation after year one. Participants will be followed for 5 years. This RCT is unique for DTD studies: 1) large sample size and long study duration (one year of controlled comparison); 2) use of a percent time in response as the primary outcome measure, given the chronic illness and its fluctuating course (vis-à-vis meeting a response criteria at a single time point); 3) inclusion of diverse measures of VNS impact on function, including quality of life, degree of disability, health status, and suicidality.",2020,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"['depression', 'patients with difficult-to-treat depression (DTD', 'Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees']","['vagus nerve stimulation', 'VNS Therapy® System as AdjunctivE Therapy']","['quality of life, degree of disability, health status, and suicidality']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220726', 'cui_str': 'Diastrophic dysplasia'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.0937023,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: conwaycr@wustl.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Olin', 'Affiliation': 'LivaNova PLC, London, United Kingdom. Electronic address: bryan.olin@livanova.com.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Aaronson', 'Affiliation': 'Sheppard Pratt Health System, Department of Psychiatry, University of Maryland, Baltimore, MD, USA. Electronic address: SAaronson@sheppardpratt.org.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, New York, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bunker', 'Affiliation': 'LivaNova PLC, Houston, TX, USA. Electronic address: Mark.Bunker@livanova.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kriedt', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: ckriedt@wustl.edu.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Greco', 'Affiliation': 'LivaNova PLC, SORIN Group Italia S.r.l., Milano, Italy. Electronic address: teresa.greco@livanova.com.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vestrucci', 'Affiliation': 'Berry Consultants, Austin, TX, USA; Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA. Electronic address: matteo@berryconsultants.net.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': 'Duke-NUS Medical School, Singapore; Duke University, Durham, NC, USA; Texas Tech University, Permian Basin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106066']
1200,32571649,"Comparison of rate of orthodontic tooth movement in adolescent patients undergoing treatment by first bicuspid extraction and en-mass retraction, associated with low level laser therapy in passive self-ligating and conventional brackets: A randomized controlled trial.","BACKGROUND


Low Level Laser Therapy (LLLT) is one of the various interventions to accelerate the rate of Orthodontic Tooth Movement (OTM) in adolescent patients who are undergoing en-mass retraction after all first bicuspid extractions.
OBJECTIVES


To assess the efficacy of LLLT in increasing the rate of OTM.
MATERIALS AND METHODS


Setting and sample population: Institutional Department of Orthodontics and Dentofacial Orthopaedics. Participants, study design and methods: 65 Patients requiring all first premolar extractions were randomly allocated to three groups. Two groups (Comprising of passive self-ligating brackets and conventional brackets) were treated with LLLT and one group served as the control (conventional brackets). The allocation ratio was 1:1:1.32. Eligibility criteria: adolescent patients with sound and healthy permanent dentition with Little's Irregularity Index<5mm.
MAIN OUTCOME


rate of tooth movement in mm/month. Randomization and blinding: computer-generated random allocation sequence; only the data analyser was blinded by coding the digital models. Patients were reviewed once every month till the completion of space closure.
STATISTICS


data normality was checked using Shapiro-Wilks test and Q-Q Plot. Parametric tests were applied for the inferential statistics (ANCOVA) with Dunnett's t test being used for post hoc analysis.
RESULTS


There was a statistically significant enhancement in the rate of OTM in the 2 experimental groups (0.68/0.67mm/month in the right and left side of the maxilla and 0.66/0.65mm/month in the right and left side of the mandible) when compared with the control group (0.48mm/month in the maxilla and 0.48mm/month in the mandible) (P<0.05), but when the 2 experimental groups were compared no difference was observed (P>0.05). No serious harms were reported.
CONCLUSION


A significant increase in the rate of OTM was observed with the application of LLLT. No difference was observed in the rate of OTM when comparing different ligation methods treated with LLLT.
REGISTRATION


National Trial Registry (CTRI No- CTRI/2018/04/013156). Protocol was not published before trial commencement.",2020,"There was a statistically significant enhancement in the rate of OTM in the 2 experimental groups (0.68/0.67mm/month in the right and left side of the maxilla and 0.66/0.65mm/month in the right and left side of the mandible) when compared with the control group (0.48mm/month in the maxilla and 0.48mm/month in the mandible) (P<0.05), but when the 2 experimental groups were compared no difference was observed (P>0.05).","['adolescent patients undergoing treatment by first bicuspid extraction and en-mass retraction, associated with low level laser therapy in passive self-ligating and conventional brackets', '65 Patients requiring all first premolar extractions', 'Setting and sample population: Institutional Department of Orthodontics and Dentofacial Orthopaedics', 'adolescent patients who are undergoing en-mass retraction after all first bicuspid extractions', ""Eligibility criteria: adolescent patients with sound and healthy permanent dentition with Little's Irregularity Index<5mm""]","['LLLT', 'Low Level Laser Therapy (LLLT', 'LLLT and one group served as the control (conventional brackets']","['rate of tooth movement in mm/month', 'rate of Orthodontic Tooth Movement (OTM', 'rate of OTM']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005373', 'cui_str': 'Bicuspid'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",65.0,0.0733495,"There was a statistically significant enhancement in the rate of OTM in the 2 experimental groups (0.68/0.67mm/month in the right and left side of the maxilla and 0.66/0.65mm/month in the right and left side of the mandible) when compared with the control group (0.48mm/month in the maxilla and 0.48mm/month in the mandible) (P<0.05), but when the 2 experimental groups were compared no difference was observed (P>0.05).","[{'ForeName': 'Hmar', 'Initials': 'H', 'LastName': 'Lalnunpuii', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Batra', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Sreevatsan', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India. Electronic address: sreevatsanr32@gmail.com.'}]",International orthodontics,['10.1016/j.ortho.2020.05.008']
1201,32578778,Comparison of the effect of ultrasound-guided thoracic paravertebral nerve block and intercostal nerve block for video-assisted thoracic surgery under spontaneous-ventilating anesthesia.,"OBJECTIVE


The aim of the current study was to compare the efficacy of two different techniques for blocking chest nerves during video-assisted thoracic surgery (VATS) under spontaneous-ventilating anesthesia.
METHODS


One hundred patients were recruited in this study and divided into two groups. The first, P group, underwent the TPVB approach; the second, I group, underwent the ICNB approach. Then, the rate of clinical efficacy, duration of the block procedure, and its complications were recorded for comparison of the effect of the two approaches.
RESULTS


No difference was found in the clinical effect of chest nerve blocks between the two groups. Two patients in the ICNB group were converted to general anesthesia due to severe mediastinal flutter (grade three). The number of patients who had grade one mediastinal flutter in the TPVB group was significantly higher than in the ICNB group. Vascular puncture was detected in four patients in the ICNB group and in one patient in the TPVB group. No other complications were observed.
CONCLUSIONS


No difference was found regarding the clinical efficacy in the two groups. However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia. Additionally, vascular puncture should receive more attention.",2020,"However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia.",['One hundred patients'],"['ICNB', 'ultrasound-guided thoracic paravertebral nerve block and intercostal nerve block for video-assisted thoracic surgery under spontaneous-ventilating anesthesia', 'video-assisted thoracic surgery (VATS']","['clinical effect of chest nerve blocks', 'clinical efficacy', 'rate of clinical efficacy, duration of the block procedure, and its complications', 'grade one mediastinal flutter', 'Vascular puncture', 'general anesthesia due to severe mediastinal flutter']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",100.0,0.0389686,"However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia.","[{'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Weibao', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Donghua', 'Initials': 'D', 'LastName': 'Shao', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.4.452']
1202,32574722,HSD3B1 (1245A>C) germline variant and clinical outcomes in metastatic castration-resistant prostate cancer patients treated with abiraterone and enzalutamide: results from two prospective studies.,"BACKGROUND


A common polymorphism (1245A>C) in the HSD3B1 gene is associated with increased de novo synthesis of androgens and worse outcomes in men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer. The objective of the study was to determine whether this polymorphism is associated with outcomes for metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone or enzalutamide.
PATIENTS AND METHODS


A total of 547 patients treated with abiraterone or enzalutamide from two prospective cohorts were evaluated. The HSD3B1 genotype was determined by targeted sequencing and/or TaqMan single-nucleotide polymorphism genotyping. In cohort 1, patients were randomized to receive abiraterone + prednisone or enzalutamide. In cohort 2, patients received either agent according to investigator's choice. Prostate-specific antigen (PSA) response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival were determined. Associations between HSD3B1 genotypes and outcomes were evaluated via univariate Cox regression. Multivariable Cox model was used to determine the independent association of each covariate.
RESULTS


The HSD3B1 variant genotype (CC) was present in 15% of patients and was associated with worse TTP [hazard ratio (HR) 1.31, 95% confidence interval (CI) 1.02-1.67, P = 0.032] and PSA response rates (48% for CC versus 62% and 65% for AA and AC, respectively [P = 0.019]), with no significant difference in TTPP (HR 1.28, 95% CI 0.99-1.66, P = 0.064). The effect of genotype was similar for treatment with abiraterone or enzalutamide with a negative test for interaction for TTPP (P = 0.997) and TTP (P = 0.749). Multivariable analysis did not show a significant association between genotype and TTP or TTPP.
CONCLUSIONS


The HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in patients with mCRPC treated with abiraterone or enzalutamide. However, the CC genotype did not provide prognostic information beyond that conferred by standard clinical variables, suggesting that it may not be a suitable stand-alone biomarker in mCRPC.",2020,"CONCLUSIONS


HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","['metastatic castration-resistant prostate cancer (mCRPC) treated with', 'metastatic castration-resistant prostate cancer patients treated with', 'men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer', '547 patients treated with']","['abiraterone + prednisone or enzalutamide', 'abiraterone and enzalutamide', 'abiraterone or enzalutamide']","['PSA response rate', 'PSA response rates', 'PSA response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival (OS', 'HSD3B1 variant genotype (CC', 'TTPP']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]",547.0,0.123766,"CONCLUSIONS


HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'BC Cancer Vancouver, Vancouver, BC, Canada.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Aragón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lozano', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taavitsainen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorente', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Hospital General Universitari de Castelló, Castellon, Spain.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Finch', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; BC Cancer Kelowna, Kelowna, BC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Romero-Laorden', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Medical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vergidis', 'Affiliation': 'BC Cancer Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cendón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oja', 'Affiliation': 'BC Cancer Surrey, Surrey, BC, Canada.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Pacheco', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'BC Cancer Abbotsford, Abbotsford, BC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Gleave', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer Vancouver, Vancouver, BC, Canada; Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castro', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain; Medical Oncology Department, Hospital Universitario Virgen de la Victoria y Regional de Málaga, Malaga, Spain. Electronic address: elena.castro@ibima.eu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.006']
1203,32579567,School-based intervention to address self-regulation and executive functioning in children attending primary schools in remote Australian Aboriginal communities.,"Executive functioning and self-regulation influence a range of outcomes across the life course including physical and mental health, educational success, and employment. Children prenatally exposed to alcohol or early life trauma (ELT) are at higher risk of impairment of these skills and may require intervention to address self-regulation deficits. Researchers partnered with the local Aboriginal health organization and schools to develop and pilot a manualized version of the Alert Program® in the Fitzroy Valley, north Western Australia, a region with documented high rates of fetal alcohol spectrum disorder and ELT. This self-controlled cluster randomized trial evaluated the effect of an 8-week Alert Program® intervention on children's executive functioning and self-regulation skills. Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study. This reflects a 75% participation rate and indicates the strong community support that exists for the study. Teachers from 26 primary school classrooms across eight Fitzroy Valley schools received training to deliver eight, one-hour Alert Program® lessons over eight-weeks to students. Student outcomes were measured by parent and teacher ratings of children's behavioral, emotional, and cognitive regulation. The mean number of lessons attended by children was 4.2. Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior. The effectiveness of future self-regulation programs may be enhanced through multimodal delivery through home, school and community based settings to maximize children's exposure to the intervention. Despite mixed findings of effect, this study was an important first step in adapting and evaluating the Alert Program® for use in remote Australian Aboriginal community schools, where access to self-regulation interventions is limited.",2020,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","['Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study', 'children attending primary schools in remote Australian Aboriginal communities', ""children's executive functioning and self-regulation skills"", 'Teachers from 26 primary school classrooms across eight Fitzroy Valley schools', 'remote Australian Aboriginal community schools']","['alcohol or early life trauma (ELT', 'School-based intervention to address self-regulation and executive functioning', '8-week Alert Program® intervention']","[""parent and teacher ratings of children's behavioral, emotional, and cognitive regulation"", 'executive functioning and behavior', ""children's executive functioning skills or behavior"", 'physical and mental health, educational success, and employment']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",271.0,0.0226753,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","[{'ForeName': 'Bree', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Adams', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Carmichael Olson', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Symons', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Mazzucchelli', 'Affiliation': 'Child and Family Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Jirikowic', 'Affiliation': 'Division of Occupational Therapy, Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Watkins', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Cross', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boulton', 'Affiliation': 'The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Edie', 'Initials': 'E', 'LastName': 'Wright', 'Affiliation': 'Western Australian Department of Education Kimberley Education Region, Broome, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Carter', 'Affiliation': 'Nindilingarri Cultural Health Services, Fitzroy Crossing, Western Australia, Australia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fitzpatrick', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0234895']
1204,32579674,Kin recognition and perceived facial similarity.,"Facial similarity between individuals informs kinship judgments in third-party kin recognition. Indeed, one study found that similarity and kinship judgments encapsulate the same information (Maloney & Dal Martello, 2006). Yet, another study found that this is not the case when comparing adult face pairs of different sex (DeBruine et al., 2009). We replicated these studies to further clarify the role of facial similarity in kin recognition. We recruited 318 raters, who were shown 50 sibling pairs and 50 age- and sex-matched unrelated pairs ranging from 3 to 17 years old. Each rater was randomly assigned to make either kinship judgments (""related"" or ""unrelated"") or similarity judgments (scale from 0 [not very similar] to 10 [very similar]). The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task. In both tasks, opposite-sex siblings were perceived to be siblings less often than same-sex siblings, and judgments of unrelated face pairs were not affected by the sex of faces. Conversely, the effect of age difference within pairs of faces differed for the two tasks: a greater age difference decreased all kinship judgments, but only decreased similarity judgments of siblings, not unrelated pairs. In line with DeBruine et al. (2009), these findings suggest that similarity and kinship judgments are highly correlated but not strictly synonymous. The OSF Pre-registration Challenge for this project can be found at osf.io/ps9hy and the data at osf.io/sef9k.",2020,"The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task.","['We recruited 318 raters, who were shown 50 sibling pairs and 50 age- and sex-matched unrelated pairs ranging from 3 to 17 years old']","['kinship judgments (""related"" or ""unrelated"") or similarity judgments (scale from 0 [not very similar] to 10 [very similar']","['Kin recognition and perceived facial similarity', 'Facial similarity']","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",,0.0189401,"The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task.","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hansen', 'Affiliation': ',.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'DeBruine', 'Affiliation': '.'}, {'ForeName': 'Iris J', 'Initials': 'IJ', 'LastName': 'Holzleitner', 'Affiliation': '.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Lee', 'Affiliation': '.'}, {'ForeName': 'Kieran J', 'Initials': 'KJ', 'LastName': ""O'Shea"", 'Affiliation': '.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Fasolt', 'Affiliation': '.'}]",Journal of vision,['10.1167/jov.20.6.18']
1205,32597615,The effect of four weeks of plyometric training on reactive strength index and leg stiffness is sport dependent.,"BACKGROUND


Plyometric exercises are often used to develop lower limb strength and performance-related biomechanics such as leg stiffness. However, the effectiveness of plyometric training may depend on participants' own training and performance demands. The purpose of this study was to examine the effect of plyometric training on Reactive Strength Index (RSI) and leg stiffness (Kleg) on young athletes of different sports.
METHODS


Forty eight female athletes (25 Taekwondo (TKD) and 23 rhythmic gymnastics (RG), mean±SD: age: 8.94±2.50 years; mass: 29.73±7.69 kg; height: 138.84±11.90 cm; training experience: 4.62±2.37 years) participated in this study. Participants were randomly assigned to experimental (PT, N.=24) and control (CG, N.=24) groups. The PT group followed a twice-weekly plyometric training program for 4 weeks. Plyometric drills lasted approximately 5-10 s, and at least 90 s rest was allowed after each set. To examine RSI, participants performed trials of five maximal CMJs. Submaximal hopping (20 hops) was performed in order to examine leg stiffness.
RESULTS


Significant interaction effect was found for RSI and the post hoc analysis showed that RSI significantly increased by 35% (P=0.017) in RG athletes, whereas a significantly reduction by 28% (P=0.004) was revealed in TKD athletes. The interaction effect between time and group was statistically significant for Kleg (P<0.05) with Kleg significantly increasing by 31% (P=0.008) in TKD athletes, but remaining unchanged (P>0.05) in RG athletes.
CONCLUSIONS


The results showed that the effect of a 4-week plyometric training program on RSI and leg stiffness is sport dependent. Further, the applied plyometric program was effective in reducing ground contact time and therefore increasing leg stiffness.",2020,"The interaction effect between time and group was statistically significant for Kleg (P<0.05) with Kleg significantly increasing by 31% (P=0.008) in TKD athletes, but remaining unchanged (P>0.05) in RG athletes.
","['young athletes of different sports', 'Forty eight female athletes (25 Taekwondo (TKD) and 23 rhythmic gymnastics (RG), mean±SD: age: 8.94±2.50 years; mass: 29.73±7.69 kg; height: 138.84±11.90 cm; training experience: 4.62±2.37 years) participated in this study']","['Plyometric exercises', 'plyometric training', 'plyometric training program']","['RSI', 'RSI and leg stiffness', 'ground contact time and therefore increasing leg stiffness', 'reactive strength index and leg stiffness', 'Reactive Strength Index (RSI) and leg stiffness (Kleg']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",48.0,0.0131781,"The interaction effect between time and group was statistically significant for Kleg (P<0.05) with Kleg significantly increasing by 31% (P=0.008) in TKD athletes, but remaining unchanged (P>0.05) in RG athletes.
","[{'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Dallas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece - gdallas@phed.uoa.gr.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Pappas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Constantinos G', 'Initials': 'CG', 'LastName': 'Ntallas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Giorgos P', 'Initials': 'GP', 'LastName': 'Paradisis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Exell', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10384-0']
1206,32597616,"Does rest interval between sets affect resistance training volume, density, and rating of perceived exertion when adopting the crescent pyramid system in young women?","BACKGROUND


The rest interval between sets can affect the responses to resistance training. Thus, the purpose of this study was to compare the effects of different rest intervals (RI) on volume, density, and rating of perceived exertion (RPE) when adopting a crescent pyramid (CP) system.
METHODS


Twenty young women (21.1±2.6 years, 1.59±0.06 m, 58.5±9.3 kg) participated in this study. All participants performed three experimental sessions of the leg press exercise in 5 sets until voluntary muscular failure at 60%, 65%, 70%, 75%, and 80% of one-repetition maximum (1RM). A randomized and crossover design was used so that in each session one of three RI (RI-1 = 1 min, RI-2 = 2 min, and RI-3 = 3 min) was tested.
RESULTS


The participants performed a significantly larger volume in the RI-3 (12820±3134 kg) when compared to RI-1 (10367±3053 kg) condition (P<0.05). The volume did not differ between RI-2 and RI-3 (P>0.05). The density was higher (P<0.05) in RI-1 (43.1±12.7 kg/s) when compared RI-2 (25.6±5.8 kg/s) and RI-3 (17.7±4.3 kg/s). The RI-2 presented higher density compared to RI-3 condition (P<0.05). The RPE was not different between the three conditions (P>0.05).
CONCLUSIONS


The use of 2 minutes of rest between sets allowed the performance of a high volume-load and density of the session in young women. In addition, the three experimental sessions provided a high perception of effort.",2020,The density was higher (P<0.05) in RI-1 (43.1±12.7 kg/s) when compared RI-2 (25.6±5.8 kg/s) and RI-3 (17.7±4.3 kg/s).,"['Twenty young women (21.1±2.6 years, 1.59±0.06 m, 58.5±9.3 kg) participated in this study', 'young women']",['leg press exercise'],"['resistance training volume, density, and rating of perceived exertion', 'volume, density, and rating of perceived exertion (RPE']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",20.0,0.0268077,The density was higher (P<0.05) in RI-1 (43.1±12.7 kg/s) when compared RI-2 (25.6±5.8 kg/s) and RI-3 (17.7±4.3 kg/s).,"[{'ForeName': 'Witalo', 'Initials': 'W', 'LastName': 'Kassiano', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil - witalokf@gmail.com.'}, {'ForeName': 'Alexandre I', 'Initials': 'AI', 'LastName': 'Medeiros', 'Affiliation': 'Federal University of Ceará (UFC), Fortaleza, Brazil.'}, {'ForeName': 'Bruna D', 'Initials': 'BD', 'LastName': 'de Vasconcelos Costa', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Ana D', 'Initials': 'AD', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Paraiba (UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Mário A', 'Initials': 'MA', 'LastName': 'Moura Simim', 'Affiliation': 'Federal University of Ceará (UFC), Fortaleza, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'de Sousa Fortes', 'Affiliation': 'Federal University of Paraiba (UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'de Oliveira Assumpção', 'Affiliation': 'Federal University of Ceará (UFC), Fortaleza, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10612-1']
1207,32597617,Effects of three different stretching protocols on hamstring muscle flexibility in professional soccer players: a randomized study.,"BACKGROUND


The current study aimed to investigate and compare the influences of global postural rieducation techniques (GPR), stretching exercises on a whole-body vibration platform (WBV), and static stretching exercises on hamstrings flexibility in elite soccer players.
METHODS


24 professional soccer players were randomly assigned to either global postural re-education (N.=8), stretching on whole-body vibration group (N.=8) or static stretching (N.=8), during the first 4 weeks of the precompetitive season. Assessment of hamstring muscle flexibility was performed using a straight leg raise test. All participants were assessed three times: at baseline, at the end of the study protocol and 14 days after the end of the study protocol.
RESULTS


The short-term increase in hamstring muscle flexibility was observed in all 3 groups, without significant differences among groups. However, after 14 days from the end of the interventions only the WBV group maintained the flexibility level achieved just at the end of the protocol with no significant changes in both legs whereas a significant decrease in the SLRT in GPR and SS groups, in right and left legs (GPR, P=0.002; P=0.015; SS, P=0.0001; P=0.0001), was observed.
CONCLUSIONS


These results would suggest that GPR, static stretching on whole-body vibration and static stretching techniques all improve hamstring muscle flexibility, but only stretching on WBV maintains the effect over time in professional soccer players.",2020,"The short-term increase in hamstring muscle flexibility was observed in all 3 groups, without significant differences among groups.","['professional soccer players', '24 professional soccer players', 'elite soccer players']","['global postural rieducation techniques (GPR), stretching exercises', 'global postural re-education (N.=8), stretching on whole-body vibration group (N.=8) or static stretching', 'stretching protocols', 'static stretching exercises']","['hamstring muscle flexibility', 'flexibility level', 'SLRT']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",24.0,0.014341,"The short-term increase in hamstring muscle flexibility was observed in all 3 groups, without significant differences among groups.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Manzi', 'Affiliation': 'IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Iellamo', 'Affiliation': 'IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Anas R', 'Initials': 'AR', 'LastName': 'Alashram', 'Affiliation': 'Department of Medicine Systems, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': ""D'onofrio"", 'Affiliation': 'Scientific Society of Sport Rehabilitation and Posturology, Rome, Italy.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Padua', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, San Raffaele University, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Casasco', 'Affiliation': 'Federazione Italiana Medicina dello Sport (FMSI), Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Annino', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, San Raffaele University, Rome, Italy - g_annino@hotmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10562-0']
1208,32597619,"Creatine supplementation improves performance, but is it safe? Double-blind placebo-controlled study.","BACKGROUND


Creatine represents a natural supplement and ergogenic aid for sport performance, but there are several concerns regarding its safety for health. The present double-blind placebo-controlled study evaluated the effect of creatine monohydrate supplementation on a panel of blood and urine health indicators in resistance training practitioners.
METHODS


Eighteen males performing resistance training three times per week were supplemented with 0.3 g/kg per day creatine monohydrate for 7 days and compared with matched controls supplemented with dextrosol. Blood and urine samples were collected pre- and 30 days post-supplementation to evaluate 41 biochemical parameters and renal function.
RESULTS


Creatine monohydrate supplementation did not cause adverse events and, as expected, promoted an increase of the performance and body weight. No modification of red blood cells parameters, white blood cells profile, blood lipid profile, metabolic and urine markers, hepatic and renal function were observed in the supplemented group.
CONCLUSIONS


Despite the expected weight increase, the creatine monohydrate supplementation is safe for health and no detrimental effects on different organs and physiological systems were observed in our cohort of volunteers.",2020,"Despite the expected weight increase, the creatine monohydrate supplementation is safe for health and no detrimental effects on different organs and physiological systems were observed in our cohort of volunteers.","['Eighteen males performing', 'resistance training practitioners']","['resistance training three times per week were supplemented with 0.3 g/kg per day creatine monohydrate for 7 days and compared with matched controls supplemented with dextrosol', 'Creatine supplementation', 'creatine monohydrate supplementation', 'placebo']","['performance and body weight', 'red blood cells parameters, white blood cells profile, blood lipid profile, metabolic and urine markers, hepatic and renal function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0873188', 'cui_str': 'Creatine monohydrate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",18.0,0.265685,"Despite the expected weight increase, the creatine monohydrate supplementation is safe for health and no detrimental effects on different organs and physiological systems were observed in our cohort of volunteers.","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Almeida', 'Affiliation': 'Laboratory of Physiology and Biokinetic, Faculty of Biological Sciences and Health, UNIG Campus V, Itaperuna, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Colombini', 'Affiliation': 'Orthopedic Biotechnology Lab, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy - alessandra.colombini@grupposandonato.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Physiology and Biokinetic, Faculty of Biological Sciences and Health, UNIG Campus V, Itaperuna, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10437-7']
1209,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
1210,32594766,Carotid Atherosclerosis Evolution When Targeting a Low-Density Lipoprotein Cholesterol Concentration <70 mg/dL After an Ischemic Stroke of Atherosclerotic Origin.,"BACKGROUND


The TST trial (Treat Stroke to Target) showed the benefit of targeting a low-density lipoprotein cholesterol (LDL-C) concentration of <70 mg/dL in terms of reducing the risk of major cardiovascular events in 2860 patients with ischemic stroke with atherosclerotic stenosis of cerebral vasculature. The impact on carotid atherosclerosis evolution is not known.
METHODS


TST-PLUS (Treat Stroke to Target-Plaque Ultrasound Study) included 201 patients assigned to an LDL-C concentration of <70 mg/dL and 212 patients assigned to a target of 100±10 mg/dL. To achieve these goals, investigators used the statin and dosage of their choice and added ezetimibe as needed. Ultrasonographers were certified and carotid ultrasound examinations were performed using M'Ath software at baseline and at 2, 3, and 5 years. All images were uploaded to the Intelligence in Medical Technologies database directly from the carotid ultrasound device. The central core laboratory performed all offline measurements of the intima-media thickness of both common carotid arteries blinded from the randomization arm. The main outcomes were newly diagnosed atherosclerotic plaque on carotid bifurcation or internal carotid artery using the Mannheim consensus definition and between-group comparison of common carotid arteries intima-media thickness change.
RESULTS


After a median follow-up of 3.1 years, the achieved LDL-C concentrations were 64 mg/dL (1.64 mmol/L) in the lower-target group and 106 mg/dL (2.72 mmol/L) in the higher-target group. Compared with the higher-target group, patients in the lower-target group had a similar incidence of newly diagnosed carotid plaque: 46/201 (5-year rate, 26.1%) versus 45/212 (5-year rate, 29.7%). The change in common carotid arteries intima-media thickness was -2.69 µm (95% CI, -6.55 to 1.18) in the higher-target group and -10.53 µm (95% CI, -14.21 to -6.85) in the lower-target group, resulting in an absolute between-group difference of -7.84 µm (95% CI, -13.18 to -2.51;  P =0.004).
CONCLUSIONS


In patients with ischemic stroke and atherosclerosis, an LDL-C target of <70 mg/dL (1.8 mmol/L) did not reduce the incidence of new carotid plaques but produced significantly greater regression of carotid atherosclerosis than an LDL-C target of 90 to 110 mg/dL. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01252875.",2020,"After a median follow-up of 3.1 years, the achieved LDL-C concentrations were 64 mg/dL (1.64 mmol/L) in the lower-target group and 106 mg/dL (2.72 mmol/L) in the higher-target group.","['201 patients assigned to a LDL-C concentration of <70 mg/dL and 212 patients assigned', '2860 patients with ischemic stroke with atherosclerotic stenosis of cerebral vasculature']","['statin and dosage of their choice and added ezetimibe', 'TST-PLUS']","['low-density lipoprotein cholesterol (LDL-C) concentration', 'carotid atherosclerosis', 'change in CCA-IMT', 'achieved LDL-C concentrations', 'incidence of newly diagnosed carotid plaque', 'incidence of new carotid plaques', 'newly diagnosed atherosclerotic plaque on carotid bifurcation or internal carotid artery origin', 'carotid arteries intima-media thickness (CCA-IMT) change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0226088', 'cui_str': 'Structure of carotid bifurcation'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",2860.0,0.405341,"After a median follow-up of 3.1 years, the achieved LDL-C concentrations were 64 mg/dL (1.64 mmol/L) in the lower-target group and 106 mg/dL (2.72 mmol/L) in the higher-target group.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Center (P.A., C.H., H.C., E.M., P.C.L., P.-J.T.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hobeanu', 'Affiliation': 'Department of Neurology and Stroke Center (P.A., C.H., H.C., E.M., P.C.L., P.-J.T.).'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'EA 2694-Santé Publique: Épidémiologie et Qualité des Soins, Université Lille, CHU Lille, France (J.L.).'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Charles', 'Affiliation': 'Department of Neurology and Stroke Center (P.A., C.H., H.C., E.M., P.C.L., P.-J.T.).'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Giroud', 'Affiliation': 'Department of Neurology, University Hospital of Dijon, University of Burgundy, France (M.G.).'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Meseguer', 'Affiliation': 'Department of Neurology and Stroke Center (P.A., C.H., H.C., E.M., P.C.L., P.-J.T.).'}, {'ForeName': 'Philippa C', 'Initials': 'PC', 'LastName': 'Lavallée', 'Affiliation': 'Department of Neurology and Stroke Center (P.A., C.H., H.C., E.M., P.C.L., P.-J.T.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gabriel Steg', 'Affiliation': 'Department of Cardiology (P.G.S.), APHP, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, France.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Vicaut', 'Affiliation': 'Department of Biostatistics, APHP, Fernand Widal Hospital, Université Paris-Diderot, Sorbonne-Paris Cité, France (É.V.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': 'Department of Endocrinology, APHP, Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France (E.B.).'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Touboul', 'Affiliation': 'Department of Neurology and Stroke Center (P.A., C.H., H.C., E.M., P.C.L., P.-J.T.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046774']
1211,32602170,Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial.,"It is unclear if genetic variants affect smoking cessation treatment response. This study tested whether variants in the cholinergic receptor nicotinic alpha 5 subunit (CHRNA5) predict response to smoking cessation medication by directly comparing the two most effective smoking cessation pharmacotherapies. In this genotype-stratified randomized, double-blind, placebo-controlled clinical trial (May 2015-August 2019 in St Louis, Missouri), smokers were randomized by genotype in blocks of six (1:1:1 ratio) to three conditions: 12 weeks of placebo (n = 273), combination nicotine patch and lozenge (combination nicotine replacement therapy, cNRT, n = 275), or varenicline (n = 274). All participants received counseling and were followed for 12 months. The primary end point was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT, week 12). Trial registration and eligibility criteria are on clinicaltrials.gov (https://clinicaltrials.gov/) (NCT02351167). We conducted the genetic analyses separately for 516 European ancestry (EA) smokers and 306 non-EA smokers (including 270 African American smokers). In African American smokers, there was a genotype-by-treatment interaction for EOT abstinence (χ 2   = 10.7, degrees of freedom = 2. P = 0.0049): specifically, cNRT was more effective in smokers with rs16969968 GG genotype than was placebo, while varenicline was more effective in smokers of GA/AA genotypes. In EA ancestry smokers, there was no significant genotype-by-treatment interaction. In the whole sample, although both were effective at EOT, only varenicline, and not cNRT, was significantly effective relative to placebo at 6-month follow-up. Importantly, this study suggests that genetic information can further enhance smoking cessation treatment effectiveness.",2020,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","['African American smokers', '516 European American (EA) smokers and 306 non-EA smokers (including 270 African American smokers']","['varenicline, and not cNRT', 'placebo', 'cholinergic receptor nicotinic alpha 5 subunit (CHRNA5', 'Varenicline and Combination Nicotine Replacement', 'varenicline', 'combination nicotine patch and lozenge (cNRT, n=275), or varenicline', 'cNRT']",['7-day point prevalence abstinence'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.197091,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Smock', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Jingling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Stoneking', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Culverhouse', 'Affiliation': 'John T. Milliken Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Amos', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1971']
1212,32602744,The Effect of Therapeutic Meibomian Glands Expression on Evaporative Dry Eye: A Prospective Randomized Controlled Trial.,"PURPOSE


To determine the clinical benefits of Meibomian gland expression therapy for the treatment of dry-eye disease caused by Meibomian gland dysfunction (MGD).
METHODS


In a prospective randomized controlled double-masked trial, 87 eyes of 44 patients with MGD and dry-eye symptoms were enrolled. Patients were randomly assigned into two groups; a study group that received therapeutic Meibomian gland expression once every month, and a control group that received sham treatment. All patients received treatment with artificial tears.
RESULTS


One week after the first treatment, the Ocular Surface Disease Index (OSDI) score improved significantly in the study group (mean change -18.5 ± 21.2,  p  = .01) but not in the control group (-3.8 ± 15.8,  p  = .16); after 1 month, both groups improved significantly (-20.5 ± 19  p  = .001 in the study group and -6.5 ± 11,  p  = .016 in the control group). The improvement continued at 2 months in the study group (-28.4 ± 26.1,  P  < .0001) and in the control group (-9.6 ± 9.9,  p  = .007). The blepharitis questionnaire score improved in the study group compared to controls after 1 week (-9.95 ± 12.52 versus -1.77 ± 9.1,  p  = .03) 1 month (-11.5 ± 10.9 versus -1.1 ± 9.4,  p  = .02) and 2 months (-16.5 ± 8.0 versus -8.8 ± 11.7,  p  = .02). Burning sensation was significantly reduced only in the study group. Mean change after 2-month treatment was -2.00 ± 1.2583 ( p  < .0001) vs -0.67 ± 1.44 ( p  = .08). The trend was similar in Eyelid scales. Conjunctival hyperemia improved only in the study group 1 week after the treatment (-0.12 ± 0.32  p  = .03).
CONCLUSION


Therapeutic Meibomian gland expression improves dry-eye symptoms in subjects with MGD, compared to conventional treatment with artificial tears.",2020,Mean change after two months treatment was -2.00±1.2583 (p < 0.0001),"['87 eyes of 44 patients with MGD and dry eye symptoms were enrolled', 'dry-eye disease caused by Meibomian gland dysfunction (MGD', 'subjects with MGD', 'Evaporative Dry Eye']","['therapeutic Meibomian gland expression once every month, and a control group which received sham treatment', 'Meibomian gland expression therapy', 'artificial tears', 'Therapeutic Meibomian Glands Expression']","['Ocular Surface Disease Index (OSDI) score', 'Mean change', 'dry eye symptoms', 'Burning sensation', 'Conjunctival hyperemia', 'blepharitis questionnaire score', 'Eye lid scales']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C5197850', 'cui_str': 'Evaporative Dry Eye Syndrome'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",87.0,0.0465455,Mean change after two months treatment was -2.00±1.2583 (p < 0.0001),"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Kaiserman', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Rabina', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University , Tel Aviv, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mimouni', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus , Haifa, Israel.'}, {'ForeName': 'Naava B', 'Initials': 'NB', 'LastName': 'Sadi Optom', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}, {'ForeName': 'Nitsan', 'Initials': 'N', 'LastName': 'Duvdevan', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus , Haifa, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Levartovsky', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ben David', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}]",Current eye research,['10.1080/02713683.2020.1789663']
1213,32598397,Profiling the health-related physical fitness of Irish adolescents: A school-level sociodemographic divide.,"BACKGROUND AND AIMS


Examining factors that may explain disparities in fitness levels among youth is a critical step in youth fitness promotion. The purpose of this study was twofold; 1) to examine the influence of school-level characteristics on fitness test performance; 2) to compare Irish adolescents' physical fitness to European norms.
METHODS


Adolescents (n = 1215, girls = 609) aged 13.4 years (SD .41) from a randomised sample of 20 secondary schools, stratified for gender, location and educational (dis)advantage, completed a series of field-based tests to measure the components of health-related physical fitness. Tests included: body mass index; 20 metre shuttle run test (20 m SRT); handgrip strength; standing broad jump (SBJ); 4 x 10 metre shuttle run; and back-saver sit-and-reach (BSR).
RESULTS


Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction). Participants in designated disadvantaged schools had significantly higher body mass index levels (p < 0.001), and significantly lower cardiorespiratory endurance (20 m SRT) (p < 0.001) and muscular strength (handgrip strength) (p = 0.018) levels compared to participants in non-disadvantaged schools. When compared to European norms, girls in this study scored significantly higher in the 20 m SRT, 4 x 10 metre shuttle run and SBJ tests, while boys scored significantly higher in the BSR test (Cohen's d 0.2 to 0.6, p < 0.001). However, European adolescents had significantly higher handgrip strength scores (Cohen's d 0.6 to 0.8, p < 0.001).
CONCLUSION


Irish adolescents compared favourably to European normative values across most components of HRPF, with the exception of muscular strength. School socioeconomic status was a strong determinant of performance among Irish adolescents. The contrasting findings for different fitness components reiterate the need for multi-component testing batteries for monitoring fitness in youth.",2020,"Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction).","[""Irish adolescents' physical fitness to European norms"", 'Irish adolescents', 'Adolescents (n = 1215, girls = 609) aged 13.4 years (SD .41) from a randomised sample of 20 secondary schools, stratified for gender, location and educational (dis)advantage, completed a series of field-based tests to measure the components of health-related physical fitness']",[],"['handgrip strength scores', 'muscular strength (handgrip strength', 'cardiorespiratory endurance', 'body mass index; 20 metre shuttle run test (20 m SRT); handgrip strength; standing broad jump (SBJ); 4 x 10 metre shuttle run; and back-saver sit-and-reach (BSR', 'body mass index levels', 'BSR test']","[{'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1215.0,0.0397272,"Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction).","[{'ForeName': 'Brendan T', 'Initials': 'BT', 'LastName': ""O'Keeffe"", 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'MacDonncha', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Purtill', 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}]",PloS one,['10.1371/journal.pone.0235293']
1214,32607967,Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam.,"AIM


Exploratory analyses evaluated patient characteristics and outcomes among patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU).
METHODS


Adults with cSSTI (surface area ≥ 75 cm 2 ) and evidence of systemic inflammation and/or underlying comorbidities were randomized 2:1 to intravenous ceftaroline fosamil (600 mg every 8 h [q8h]) or vancomycin (15 mg/kg every 12 h) plus aztreonam (1 g q8h) for 5-14 days. Clinical response and ICU length of stay (LOS) within first hospitalization were evaluated in the modified intent-to-treat (MITT) and clinically evaluable (CE) populations; a Cox proportional hazards model identified factors associated with increased hospital LOS.
RESULTS


Overall, 42 of 761 randomized patients were admitted to the ICU (ceftaroline fosamil, n = 32; vancomycin plus aztreonam, n = 10) prior to, or at start of, study treatment. Baseline differences between the ICU and non-ICU populations were indicative of more severe disease in ICU patients; within this subset, there were also some notable imbalances between treatment groups. Clinical cure rates at test-of-cure (ceftaroline fosamil vs. vancomycin plus aztreonam) were generally similar in the non-ICU and ICU subsets (MITT population 79% vs. 79% and 69% vs. 90.0%, respectively; CE population 87% vs. 85% and 80% vs. 89%, respectively). Median ICU LOS was 8 vs. 13 days, respectively. ICU admission was a risk factor predicting increased hospital LOS (P < 0.001).
CONCLUSIONS


Clinical outcomes for patients admitted to the ICU were generally similar to non-ICU patients, despite more severe baseline disease, with shorter median treatment duration in the ceftaroline fosamil group. ICU admission was associated with longer hospital LOS. Given the small sample size and unbalanced patient and disease characteristics within the ICU subgroup, differences between treatment groups should be interpreted with caution.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01499277.",2020,"ICU admission was a risk factor predicting increased hospital LOS (P < 0.001).
","['42 of 761 randomized patients were admitted to the ICU (ceftaroline fosamil, n\u2009=\u200932', ' n\u2009=\u200910) prior to, or at start of, study treatment', 'Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit', 'Adults with cSSTI (surface area\u2009≥\u200975 cm 2 ) and evidence of systemic inflammation and/or underlying comorbidities', 'patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU']","['vancomycin plus aztreonam', 'vancomycin', 'aztreonam', 'intravenous ceftaroline fosamil', 'Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam']","['hospital LOS', 'Clinical response and ICU length of stay (LOS', 'Clinical cure rates', 'Median ICU LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004521', 'cui_str': 'Aztreonam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",761.0,0.064208,"ICU admission was a risk factor predicting increased hospital LOS (P < 0.001).
","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sánchez-García', 'Affiliation': 'Hospital Clínico San Carlos, Calle del Prof Martín Lagos, Madrid, Spain. miguelsanchez.hcsc@gmail.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hammond', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Jean Li', 'Initials': 'JL', 'LastName': 'Yan', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kantecki', 'Affiliation': 'Pfizer, Paris, France.'}, {'ForeName': 'Wajeeha', 'Initials': 'W', 'LastName': 'Ansari', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dryden', 'Affiliation': 'Royal Hampshire County Hospital, Winchester, UK.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00297-3']
1215,32576828,Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial.,"Short-term fasting protects tumor-bearing mice against the toxic effects of chemotherapy while enhancing therapeutic efficacy. We randomized 131 patients with HER2-negative stage II/III breast cancer, without diabetes and a BMI over 18 kg m -2 , to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy. Here we show that there was no difference in toxicity between both groups, despite the fact that dexamethasone was omitted in the FMD group. A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039). Moreover, per-protocol analysis reveals that the Miller&Payne 4/5 pathological response, indicating 90-100% tumor-cell loss, is more likely to occur in patients using the FMD (OR 4.109, P = 0.016). Also, the FMD significantly curtails chemotherapy-induced DNA damage in T-lymphocytes. These positive findings encourage further exploration of the benefits of fasting/FMD in cancer therapy. Trial number: NCT02126449.",2020,"A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039).","['131 patients with HER2-negative stage II/III breast cancer, without diabetes and a BMI over 18\u2009kg\u2009m -2 , to receive either a']","['Fasting mimicking diet', 'chemotherapy', 'fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy', 'dexamethasone']","['Miller&Payne 4/5 pathological response', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",131.0,0.0375448,"A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039).","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Rieneke T', 'Initials': 'RT', 'LastName': 'Lugtenberg', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Marij J P', 'Initials': 'MJP', 'LastName': 'Welters', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Ilina', 'Initials': 'I', 'LastName': 'Ehsan', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Maaike P G', 'Initials': 'MPG', 'LastName': 'Vreeswijk', 'Affiliation': 'Department of Human Genetics, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Vincent T H B M', 'Initials': 'VTHBM', 'LastName': 'Smit', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hiltje', 'Initials': 'H', 'LastName': 'de Graaf', 'Affiliation': 'Department of Medical Oncology, Medical center Leeuwarden, P.O. Box 888, 8901 NR, Leeuwarden, The Netherlands.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Heijns', 'Affiliation': 'Department of Medical Oncology, Amphia, P.O. Box 90157, 4800 RL, Breda, The Netherlands.'}, {'ForeName': 'Johanneke E A', 'Initials': 'JEA', 'LastName': 'Portielje', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Agnes J', 'Initials': 'AJ', 'LastName': 'van de Wouw', 'Affiliation': 'Department of Medical Oncology, Viecuri, 5912BL, Venlo, The Netherlands.'}, {'ForeName': 'Alex L T', 'Initials': 'ALT', 'LastName': 'Imholz', 'Affiliation': 'Department of Medical Oncology, Deventer hospital, P.O. Box 5001, 7416 SE, Deventer, The Netherlands.'}, {'ForeName': 'Lonneke W', 'Initials': 'LW', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Oncology, Deventer hospital, P.O. Box 5001, 7416 SE, Deventer, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Vrijaldenhoven', 'Affiliation': 'Department of Medical Oncology, Noordwest hospital group, location Alkmaar, P.O. Box 501, 1815 JD, Alkmaar, The Netherlands.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Baars', 'Affiliation': 'Department of Medical Oncology, Hospital Gelderse vallei, 6710 HN, Ede, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Marjolijn Duijm-de', 'Initials': 'MD', 'LastName': 'Carpentier', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, P.O. Box 9600, 2300RC, Leiden, The Netherlands.'}, {'ForeName': 'Jacobus J M', 'Initials': 'JJM', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Johan W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Longo', 'Affiliation': 'Longevity Institute, School of Gerontology, and Department of Biological Sciences, University of Southern California, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Department of Endocrinology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. j.r.kroep@lumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-020-16138-3']
1216,32577737,Four-Week Ankle-Rehabilitation Programs in Adolescent Athletes With Chronic Ankle Instability.,"CONTEXT


Researchers have shown that rehabilitation programs incorporating resistance-band and balance-board exercises are effective for improving clinical measures of function and patient-reported outcomes in individuals with chronic ankle instability (CAI). However, whether combining the 2 exercises increases improvement is unknown.
OBJECTIVE


To determine the effectiveness of 3 rehabilitation programs on clinical measures of balance and self-reported function in adolescent patients with CAI.
DESIGN


Randomized controlled clinical trial (Trail Registration Number: ClinicalTrails.gov: NCT03447652).
SETTING


High school athletic training facilities.
PATIENTS OR OTHER PARTICIPANTS


Forty-three patients with CAI (age = 16.37 ± 1.00 years, height = 171.75 ± 12.05 cm, mass = 69.38 ± 18.36 kg) were block randomized into 4 rehabilitation groups.
INTERVENTION(S)


Protocols were completed 3 times per week for 4 weeks. The resistance-band group performed 3 sets of 10 repetitions of ankle plantar flexion, dorsiflexion, inversion, and eversion with a resistance band. The Biomechanical Ankle Platform System group performed 5 trials of clockwise and counterclockwise rotations, changing direction every 10 seconds during each 40-second trial. The combination group completed resistance-band and Biomechanical Ankle Platform System programs during each session. The control group did not perform any exercises.
MAIN OUTCOME MEASURE(S)


Variables were assessed before and after the intervention: time-in-balance test, foot-lift test, Star Excursion Balance Test, side-hop test, figure-8 hop test, Foot and Ankle Ability Measure, and Cumberland Ankle Instability Tool. We conducted 4 separate multivariate repeated-measures analyses of variance, followed by univariate analyses for any findings that were different.
RESULTS


Using the time-in-balance test, foot-lift test, Star Excursion Balance Test (medial, posteromedial, and posterolateral directions), and figure-8 hop test, we detected improvement for each rehabilitation group compared with the control group (P < .05). However, no intervention group was superior.
CONCLUSIONS


All 3 rehabilitation groups demonstrated improvement compared with the control group, yet the evidence was too limited to support a superior intervention. Over a 4-week period, either of the single-task interventions or the combination intervention can be used to combat the residual deficits associated with CAI in an adolescent patient population.",2020,"All 3 rehabilitation groups demonstrated improvement compared with the control group, yet the evidence was too limited to support a superior intervention.","['Adolescent Athletes', 'individuals with chronic ankle instability (CAI', 'Forty-three patients with CAI (age = 16.37 ± 1.00 years, height = 171.75 ± 12.05 cm, mass = 69.38 ± 18.36 kg', 'High school athletic training facilities', 'adolescent patients with CAI', 'adolescent patient population']",['3 rehabilitation programs'],"['time-in-balance test, foot-lift test, Star Excursion Balance Test, side-hop test, figure-8 hop test, Foot and Ankle Ability Measure, and Cumberland Ankle Instability Tool', 'time-in-balance test, foot-lift test, Star Excursion Balance Test (medial, posteromedial, and posterolateral directions']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",43.0,0.0290524,"All 3 rehabilitation groups demonstrated improvement compared with the control group, yet the evidence was too limited to support a superior intervention.","[{'ForeName': 'M Spencer', 'Initials': 'MS', 'LastName': 'Cain', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Ban', 'Affiliation': 'Department of Kinesiology and Health, Georgia State University, Atlanta.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Therapy, Georgia State University, Atlanta.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Geil', 'Affiliation': 'Department of Exercise Science and Sports Management, Kennesaw State University, Georgia.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Goerger', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Shelley W', 'Initials': 'SW', 'LastName': 'Linens', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene. Dr Linens is now with the Department of Kinesiology, University of North Carolina at Charlotte.'}]",Journal of athletic training,['10.4085/1062-6050-41-19']
1217,32578718,Subjective time under altered states of consciousness in ayahuasca users in shamanistic rituals involving music.,"Ayahuasca is described as a hallucinogenic substance whose property is to alter the subjective experience of time and impair the perception of the passage of time during stimuli of more than two to three seconds. The dose-dependent effects of two concentrations of ayahuasca in the ritualistic context were investigated employing temporal reproduction tasks in participants experienced in shamanistic ayahuasca rituals. The study was conducted on nine healthy volunteers who ingested two doses of ayahuasca at two times during a ritual session. The doses of each session, consumed in amounts ranging from 20 to 60 mL, were either of low concentration or of experimental ayahuasca according to a double-blind procedure. Participants performed the task of immediately listening and reproducing, with a laptop, 20-s musical stimuli during the session. The results showed that significant temporal distortion was triggered by the musical stimulus presented without the ingestion of ayahuasca, with means of 16.33 to 16.52 s. There were minor temporal distortions after ingestion of ayahuasca: a mean of 17.91 s for control ayahuasca and of 18.38 s for experimental ayahuasca. These results with less temporal distortion among participants with ayahuasca intake disagree with other studies of hallucinogens involving temporal reproduction.",2020,"The results showed that significant temporal distortion was triggered by the musical stimulus presented without the ingestion of ayahuasca, with means of 16.33 to 16.52 s.","['ayahuasca users in shamanistic rituals involving music', 'participants with ayahuasca intake disagree with other studies of hallucinogens involving temporal reproduction', 'nine healthy volunteers who ingested two doses of ayahuasca at two times during a ritual session', 'participants experienced in shamanistic ayahuasca rituals']",['ayahuasca'],['Subjective time under altered states of consciousness'],"[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0233622', 'cui_str': 'Compulsion expressed as ritual'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150450', 'cui_str': 'Altered state of consciousness'}]",9.0,0.0386083,"The results showed that significant temporal distortion was triggered by the musical stimulus presented without the ingestion of ayahuasca, with means of 16.33 to 16.52 s.","[{'ForeName': 'A P S', 'Initials': 'APS', 'LastName': 'Campagnoli', 'Affiliation': 'Departamento de Psicologia, Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brasil.'}, {'ForeName': 'L A S', 'Initials': 'LAS', 'LastName': 'Pereira', 'Affiliation': 'Departamento de Psicologia, Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brasil.'}, {'ForeName': 'J L O', 'Initials': 'JLO', 'LastName': 'Bueno', 'Affiliation': 'Departamento de Psicologia, Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brasil.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20209278']
1218,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children.
OBJECTIVES


To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
METHODS


240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months.
CONCLUSIONS


If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, 551 W 51st Pl, Hialeah, FL 33012, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, 915 West State Street, West Lafayette, IN 47907-2053, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061']
1219,32579549,"A novel nutritional supplement containing amino acids and chromium decreases postprandial glucose response in a randomized, double-blind, placebo-controlled study.","High postprandial blood glucose levels are associated with increased mortality, cardiovascular events and development of diabetes in the general population. Interventions targeting postprandial glucose have been shown to prevent both cardiovascular events and diabetes. This study evaluates the efficacy and safety of a novel nutritional supplement targeting postprandial glucose excursions in non-diabetic adults. Sixty overweight healthy male and female participants were recruited at two centers and randomized in a double-blind, placebo-controlled, crossover design. The supplement, a water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal. The primary endpoint was the incremental area under the curve (iAUC) for venous blood glucose from 0 to 120 minutes. Secondary endpoints included glucose iAUC 0-180 minutes and the maximum glucose concentration (Cmax), for both venous and capillary blood glucose. In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017). The Cmax for venous blood glucose for the supplement and placebo were 6.45 (0.12) versus 6.10 (<0.12), respectively, a difference of -0.35 mmol/L (95% CI -0.17 to -0.53, p<0.001). In the per protocol-analysis (n = 48), the supplement resulted in a decreased Cmax compared to placebo from 6.42 (0.14) to 6.12 (0.14), a difference of -0.29 mmol/L (95% CI -0.12 to -0.47, p = 0.002). No significant differences in capillary blood glucose were found, as measured by regular bed-side glucometers. The nutritional supplement drink containing amino acids and chromium improves the postprandial glucose homeostasis in overweight adults without diabetes. Future studies should clarify, whether regular consumption of the supplement improves markers of disease or could play a role in a diet aiming at preventing the development of diabetes.",2020,"In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017).","['Sixty overweight healthy male and female participants', 'non-diabetic adults', 'overweight adults without diabetes']","['novel nutritional supplement targeting postprandial glucose excursions', 'nutritional supplement drink containing amino acids and chromium', 'water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal', 'amino acids and chromium', 'placebo']","['glucose iAUC 0-180 minutes and the maximum glucose concentration (Cmax), for both venous and capillary blood glucose', 'High postprandial blood glucose levels', 'capillary blood glucose', 'incremental area under the curve (iAUC) for venous blood glucose', 'Cmax for venous blood glucose', 'efficacy and safety', 'postprandial glucose homeostasis', 'postprandial glucose response', 'mortality, cardiovascular events and development of diabetes', 'venous blood glucose iAUC0-120min']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",60.0,0.255059,"In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017).","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Östman', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Azat', 'Initials': 'A', 'LastName': 'Samigullin', 'Affiliation': 'StarScience GmbH, Heidelberg, Germany.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Heyman-Lindén', 'Affiliation': 'Aventure AB, Lund, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Andersson', 'Affiliation': 'Aventure AB, Lund, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Björck', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Öste', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Humpert', 'Affiliation': 'StarScience GmbH, Heidelberg, Germany.'}]",PloS one,['10.1371/journal.pone.0234237']
1220,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION


Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.
METHODS


The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.
DISCUSSION


Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.
TRIAL REGISTRATION


This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067']
1221,32446176,"Efficacy and safety of safinamide as an add-on therapy to L-DOPA for patients with Parkinson's disease: A randomized, double-blind, placebo-controlled, phase II/III study.","INTRODUCTION


Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PD patients with wearing-off.
METHODS


This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PD patients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index.
RESULTS


A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%).
CONCLUSION


As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PD patients with wearing-off.",2020,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[""patients with Parkinson's disease"", 'PD patients with wearing-off', 'Japanese PD patients with wearing-off on l-DOPA treatment', 'A total of 406 subjects were randomized, of whom 349 completed the study']","['sodium channel inhibitor', 'safinamide', 'placebo (P), safinamide 50\xa0mg/day (S50), or safinamide 100\xa0mg/day (S100', 'placebo']","['Adverse events', 'dyskinesias', 'Efficacy and safety', 'mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part', 'visual hallucinations', 'mean daily ON-time', 'efficacy and safety', ""mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index"", 'change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time', 'ON-time and improved PD symptoms/signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4475891', 'cui_str': 'safinamide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4475900', 'cui_str': 'safinamide 100 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0233763', 'cui_str': 'Visual hallucinations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",406.0,0.175291,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Sasagawa', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shizugawa, Tohon, Ehime, 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime, 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.04.012']
1222,32450080,Access to single-visit IUD insertion at obstetrician-gynecology practices in Ohio: An audit study.,"OBJECTIVE


Single-visit intrauterine device (IUD) insertion protocols are recommended. We assessed the availability of single-visit IUD insertions, and whether access to these services varies by age, race or parity.
STUDY DESIGN


Using audit study methodology, we called a random sample of 396 obstetrician-gynecology practices in Ohio while posing as a potential client seeking an IUD insertion appointment. Callers used eight standardized scripts and noted justifications for protocols offered by clinic staff. Practices were randomized to follow a balanced 3×2 factorial design, whereby practices were assigned to one of two conditions: (1) age (18 vs. 30 years of age); (2) race (white vs. black); and (3) parity. Multivariable logistic regression was used to control for clinics rural vs. urban location while considering the effects of these variables on service provision.
RESULTS


Almost all (95%) of the practices called offered IUD placement, of which 92% required multiple appointments for IUD insertion. Although access to single-visit IUD services did not vary by age or race, we found that parity was associated with clinics' willingness to schedule a single-visit insertion visit (OR = 3.84, 95% CI = 1.23, 12.04). The most frequent justification provided by clinic staff for their multiple-appointment protocol was the need to verify insurance coverage or order the device directly through the patient's insurance company.
CONCLUSION


Ohio patients seeking IUD placement must typically make more than one clinic visit.
IMPLICATIONS


Efforts are needed to reassure Ohio clinics that IUDs are routinely covered by insurers and to increase access to same-day IUD placement for women in Ohio, as the requirement to attend multiple clinics appointments to obtain a desired contraceptive may pose an insurmountable barrier to care for those with the fewest resources.",2020,"RESULTS


Almost all (95%) of the practices called offered IUD placement,",['396 obstetrician-gynecology practices in Ohio while posing as a potential client seeking an IUD insertion appointment'],[],[],"[{'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],[],396.0,0.233788,"RESULTS


Almost all (95%) of the practices called offered IUD placement,","[{'ForeName': 'Jaclyn J', 'Initials': 'JJ', 'LastName': 'Serpico', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA; The Ohio State University, College of Arts and Sciences, Columbus, OH 43210, USA. Electronic address: serpico.6@osu.edu.'}, {'ForeName': 'JaNelle M', 'Initials': 'JM', 'LastName': 'Ricks', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA.'}, {'ForeName': 'Wendy G', 'Initials': 'WG', 'LastName': 'Smooth', 'Affiliation': 'The Ohio State University, College of Arts and Sciences, Columbus, OH 43210, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Romanos', 'Affiliation': 'Planned Parenthood of Greater Ohio, Columbus, OH 43215, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Brook', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA; The Ohio State University Wexner Medical Center, Medical Scientist Training Program, Columbus, OH 43210, USA.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Gallo', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA.'}]",Contraception,['10.1016/j.contraception.2020.05.007']
1223,32451267,In vitro evaluation of shear bond strength of orthodontic metal brackets to aged composite using a self-adhesive composite: Effect of surface conditioning and different bonding agents.,"OBJECTIVES


Bracket bonding to composite surfaces is increasing. This study sought to assess the effect of different adhesives (acid etchant+Transbond XT™, acid etchant+Vertise Flow™, Vertise Flow™) with different surface treatments (no preparation, bur, sandblasting, Er:YAG laser) on shear bond strength (SBS) of metal brackets to aged composite.
MATERIALS AND METHODS


In this in vitro, experimental study, Filtek™ Z250 composite discs were fabricated (10×4mm). After thermocycling (10,000 cycles between 5-55°C), the samples were randomly divided into three groups (n=48) based on the type of adhesive namely acid etchant+Transbond XT™, Vertise Flow™, and acid etchant+Vertise Flow™. Samples in each group were randomly divided into four subgroups (n=12) based on the surface treatment including no-treatment, diamond bur, sandblasting and Er:YAG laser. Samples in each group were randomly divided into three subgroups (n=12) based on the type of adhesive namely acid etchant+Transbond XT™, Vertise Flow™, and acid etchant+Vertise Flow™. After bracket bonding to composite discs, the samples underwent thermocycling (5000 cycles between 5-55°C), and their SBS was measured in a universal testing machine. The samples were then inspected under a stereomicroscope at x10 magnification to determine their mode of failure and adhesive remnant index (ARI).
RESULTS


No significant difference was noted in SBS between adhesives in no-preparation and laser groups (P>0.05). In all adhesive groups, sandblast had highest SBS, but it was not significantly different in Vertise Flow™ groups, with and without etching. The SBS provided by acid etchant+Transbond XT™ was significantly higher than that of the other two adhesives (P<0.05). The SBS of sandblasted samples was significantly higher compared with other surface treatments in all adhesive subgroups (P<0.05).
CONCLUSION


Bracket bonding to aged composite using Vertise Flow™ with or without surface treatment can serve as an alternative to the conventional orthodontic adhesives.",2020,"In all adhesive groups, sandblast had highest SBS, but it was not significantly different in Vertise Flow™ groups, with and without etching.","['orthodontic metal brackets to aged composite using a self-adhesive composite', 'In this in vitro, experimental study, Filtek™ Z250 composite discs were fabricated (10×4mm']","['adhesive namely acid etchant+Transbond XT™, Vertise Flow™, and acid etchant+Vertise Flow™', 'surface treatment including no-treatment, diamond bur, sandblasting and Er:YAG laser', 'adhesives (acid etchant+Transbond XT™, acid etchant+Vertise Flow™, Vertise Flow™) with different surface treatments (no preparation, bur, sandblasting, Er:YAG laser']","['SBS of sandblasted samples', 'shear bond strength (SBS', 'SBS']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C3659065', 'cui_str': 'vertise flow'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0174207,"In all adhesive groups, sandblast had highest SBS, but it was not significantly different in Vertise Flow™ groups, with and without etching.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Restorative Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golnoosh', 'Initials': 'G', 'LastName': 'Alimohammadi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh Hosseinzadeh', 'Initials': 'TH', 'LastName': 'Nik', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Etemadi', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Periodontics, Faculty of Dentistry, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Behrad', 'Initials': 'B', 'LastName': 'Tanbakuchi', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: behrad.tanbakuchi@yahoo.com.'}]",International orthodontics,['10.1016/j.ortho.2020.04.005']
1224,32456442,"Herbal Drug EPs 7630  versus  Amoxicillin in Patients with Uncomplicated Acute Bacterial Rhinosinusitis: A Randomized, Open-Label Study.","OBJECTIVE


Previous investigations suggest the use of extract from the root of  Pelargonium sidoides  (EPs 7630) for the therapy of uncomplicated acute upper airway inflammations, due to its strong antimicrobial and immunomodulatory effect. We aimed to compare clinical efficacy, safety and bactericidal effect of EPs 7630 and amoxicillin monotherapy in treatment of patients with mild to moderate acute bacterial rhinosinusitis (ABRS).
METHODS


Fifty ABRS patients were divided into two groups by randomization. Group 1 (n = 25) received EPs 7630 tablets, 3 × 20 mg/day per os for 10 days. Group 2 (n = 25) received amoxicillin tablets 3 × 500 mg/day per os, for 10 days. We assessed total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion), before and after treatment. Samples of discharge taken from the middle meatus of all patients were cultivated for bacteria before and after therapy.
RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters). However, there were no differences in absolute improvement of rhinorrhea score and postnasal drip score between groups ( P  = .248;  P  = .679, respectively). Fewer types of bacteria grew on culture from middle meatal samples in EPs 7630 group compared to amoxicillin group. There were no reported adverse events from patients from either group.
CONCLUSION


Our results demonstrated better clinical and antimicrobial efficacy of EPs 7630 than amoxicillin. EPs 7630 was shown as a potent agent and good alternative to antibiotic treatment of uncomplicated ABRS.",2020,"RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters).","['Fifty ABRS patients', 'Patients with Uncomplicated Acute Bacterial Rhinosinusitis', 'patients with mild to moderate acute bacterial rhinosinusitis (ABRS']","['amoxicillin', 'EPs 7630 and amoxicillin monotherapy', 'amoxicillin tablets', 'Herbal Drug EPs 7630  versus  Amoxicillin']","['rhinorrhea score and postnasal drip score', 'clinical efficacy, safety and bactericidal effect', 'TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion', 'adverse events', 'total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1244600', 'cui_str': 'Amoxicillin Oral Tablet'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0443266', 'cui_str': 'Mucopurulent'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",50.0,0.0241304,"RESULTS


Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P  < .001 for all parameters).","[{'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Perić', 'Affiliation': 'Department of Otorhinolaryngology, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Gaćeša', 'Affiliation': 'ENT Hospital ""Dr. Žutić"", Belgrade, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Barać', 'Affiliation': 'School of Medicine, University in Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Sotirović', 'Affiliation': 'Department of Otorhinolaryngology, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}, {'ForeName': 'Aneta V', 'Initials': 'AV', 'LastName': 'Perić', 'Affiliation': 'Institute for Pharmacy, Military Medical Academy Faculty of Medicine, University of Defence, Belgrade, Serbia.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420918266']
1225,32459600,"ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia.","PURPOSE


Acalabrutinib, a highly selective, potent, Bruton tyrosine kinase inhibitor, was evaluated in this global, multicenter, randomized, open-label, phase III study in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).
METHODS


Eligible patients, aged ≥ 18 years with R/R CLL, were randomly assigned 1:1 centrally and stratified by del(17p) status, Eastern Cooperative Oncology Group performance status score, and number of prior lines of therapy. Patients received acalabrutinib monotherapy or investigator's choice (idelalisib plus rituximab [I-R] or bendamustine plus rituximab [B-R]). The primary end point was progression-free survival (PFS) assessed by an independent review committee (IRC) in the intent-to-treat population. Key secondary end points included IRC-assessed overall response rate, overall survival, and safety.
RESULTS


From February 21, 2017, to January 17, 2018, a total of 398 patients were assessed for eligibility; 310 patients were randomly assigned to acalabrutinib monotherapy (n = 155) or investigator's choice (n = 155; I-R, n = 119; B-R, n = 36). Patients had received a median of two prior therapies (range, 1-10). After a median follow-up of 16.1 months (range, 0.03-22.4 months), median PFS was significantly longer with acalabrutinib monotherapy (PFS not reached) compared with investigator's choice (16.5 months [95% CI, 14.0 to 17.1 months]; hazard ratio, 0.31 [95% CI, 0.20 to 0.49];  P  < .0001). Estimated 12-month PFS was 88% (95% CI, 81% to 92%) for acalabrutinib and 68% (95% CI, 59% to 75%) for investigator's choice. Serious adverse events occurred in 29% of patients (n = 44 of 154) treated with acalabrutinib monotherapy, 56% (n = 66 of 118) with I-R, and 26% (n = 9 of 35) with B-R. Deaths occurred in 10% (n = 15 of 154), 11% (n = 13 of 118), and 14% (n = 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively.
CONCLUSION


Acalabrutinib significantly improved PFS compared with I-R or B-R and has an acceptable safety profile in patients with R/R CLL.",2020,"Serious adverse events occurred in 29% of patients (n = 44 of 154) treated with acalabrutinib monotherapy, 56% (n = 66 of 118) with I-R, and 26% (n = 9 of 35) with B-R. Deaths occurred in 10% (n = 15 of 154), 11% (n = 13 of 118), and 14% (n = 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively.
","['Relapsed or Refractory Chronic Lymphocytic Leukemia', 'Eligible patients, aged ≥ 18 years with R/R CLL', '398 patients were assessed for eligibility; 310 patients', 'patients with R/R CLL', 'patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL', 'From February 21, 2017, to January 17, 2018']","['Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab', ""acalabrutinib monotherapy or investigator's choice (idelalisib plus rituximab [I-R] or bendamustine plus rituximab [B-R"", 'del(17p', 'acalabrutinib monotherapy']","['performance status score, and number of prior lines of therapy', 'PFS', 'Serious adverse events', 'progression-free survival (PFS) assessed by an independent review committee (IRC', 'Estimated 12-month PFS', 'IRC-assessed overall response rate, overall survival, and safety', 'median PFS']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0278791', 'cui_str': 'Chronic lymphocytic leukaemia refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}]","[{'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",398.0,0.249092,"Serious adverse events occurred in 29% of patients (n = 44 of 154) treated with acalabrutinib monotherapy, 56% (n = 66 of 118) with I-R, and 26% (n = 9 of 35) with B-R. Deaths occurred in 10% (n = 15 of 154), 11% (n = 13 of 118), and 14% (n = 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively.
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele, Milano, Italy.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pluta', 'Affiliation': 'Szpital Specjalistyczny w Brzozowie im. Ks. Markiewicza, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku, Brzozow, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wach', 'Affiliation': 'Department of Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lysak', 'Affiliation': 'Fakultní Nemocnice Plzeň, Pilsen, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kozak', 'Affiliation': 'Fakultní Nemocnice Královske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Simkovic', 'Affiliation': 'University Hospital Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Kaplan', 'Affiliation': 'Dnipropetrovsk City Clinical Hospital No. 4, Dnipropetrovsk, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Kraychok', 'Affiliation': 'National Cancer Institute, Kiev, Ukraine.'}, {'ForeName': 'Arpad', 'Initials': 'A', 'LastName': 'Illes', 'Affiliation': 'University of Debrecen, Faculty of Medicine, Department of Hematology, Debrecen, Hungary.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Serna', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Dolan', 'Affiliation': 'Saint John Regional Hospital, University of New Brunswick, St John, New Brunswick, Canada.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Campbell', 'Affiliation': 'Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Musuraca', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Jacob', 'Affiliation': 'Royal Wolverhampton Hospital National Health Service Trust, Wolverhampton, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Avery', 'Affiliation': 'Nebraska Hematology Oncology, Lincoln, NE.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, CA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, CA.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Quah', 'Affiliation': 'Acerta Pharma (a member of the AstraZeneca group), South San Francisco, CA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Institute of Oncology, Kraków, Poland.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03355']
1226,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES


Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome.
METHODS


Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention.
RESULTS


Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself.
LIMITATIONS


The mean level of procrastination in this study was lower than in other treatment studies of procrastination.
CONCLUSIONS


Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579']
1227,32460875,Correction to: Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"[""patients with Parkinson's disease""]",['robot-assisted gait training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]",[],,0.0670688,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Min-Gu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Seo Jung', 'Initials': 'SJ', 'LastName': 'Yun', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Hyun Iee', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Eunkyung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Hyun Haeng', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Byung-Mo', 'Initials': 'BM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea. hgseo80@gmail.com.'}]",Trials,['10.1186/s13063-020-04437-5']
1228,32460879,Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial.,"BACKGROUND


There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice.
METHODS/DESIGN


DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial.
DISCUSSION


Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.",2020,"DISCUSSION


Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis.","['In September 2019 the study began recruiting children aged 6\u2009months to 18\u2009years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72\u2009h of gastroenteritis symptoms and who were administered a dose of', 'six Canadian pediatric emergency departments (EDs', '1030 children (1:1 allocation via an internet-based, third-party, randomization service', 'children presenting to emergency departments with vomiting secondary to acute gastroenteritis', 'children focusing on post-emergency department visit and patient-centered outcomes', 'children with acute gastroenteritis', 'Pediatric Gastroenteritis', 'pediatric Acute GastroEnteritis (DOSE-AGE']","['ondansetron', 'Multi-dose Oral Ondansetron', 'ondansetron oral solution or placebo', 'placebo']","['duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety', 'development of moderate-to-severe gastroenteritis in the 7\u2009days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1238268', 'cui_str': 'Ondansetron Oral Solution [Zofran]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1030.0,0.588411,"DISCUSSION


Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Stephen.freedman@ahs.ca.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Alberta Children's Hospital, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'The Hospital for Sick Children, Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Pechlivanoglou', 'Affiliation': 'The Hospital for Sick Children, Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Hopkin', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Departments of Pediatric Emergency Medicine and Pediatrics, CHU Sainte-Justine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Plint', 'Affiliation': ""Children's Hospital of Eastern Ontario, Departments of Pediatric and Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dixon', 'Affiliation': ""Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Women and Children's Health Research Institute, Edmonton, AB, Canada.""}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Beer', 'Affiliation': ""Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Joubert', 'Affiliation': ""Division of Paediatric Emergency Medicine, Department of Paediatrics, Children's Hospital LHSC, Western University, London, ON, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics and the Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'Divisions of Emergency Medicine and Clinical Pharmacology and Toxicology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': ""Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04347-6']
1229,32605074,Reduction of High Expressed Emotion and Treatment Outcomes in Anorexia Nervosa-Caregivers' and Adolescents' Perspective.,"High expressed emotion (EE) is common in caregivers of patients with anorexia nervosa (AN) and associated with poorer outcome for patients. In this study, we examined the prevalence of high EE in caregivers of adolescents with AN and analyzed predictors for EE using multivariate linear regression models. We further analyzed whether EE is reduced by the ""Supporting Carers of Children and Adolescents with Eating Disorders in Austria"" (SUCCEAT) intervention using general linear mixed models and whether a reduction of EE predicts patients' outcomes. Caregivers were randomly allocated to the SUCCEAT workshop ( N  = 50) or online intervention ( N  = 50) and compared to a comparison group ( N  = 49). EE and patients' outcomes were assessed at the baseline, post-intervention, and at the 12-month follow-up. Up to 47% of caregivers showed high EE. Lower caregiver skills, higher AN symptom impact, higher levels of depression and motivation to change in caregivers were significant predictors for high EE. EE significantly decreased in the SUCCEAT groups and the comparison group according to the caregivers', but not the patients' perspective. The level of reduction could partially predict subjective improvement and improvement in clinically assessed AN symptoms and body mass index of patients. Implementing interventions for caregivers addressing EE in the treatment of adolescents with AN is strongly recommended.",2020,"EE significantly decreased in the SUCCEAT groups and the comparison group according to the caregivers', but not the patients' perspective.","['caregivers of patients with anorexia nervosa (AN', ""Anorexia Nervosa-Caregivers' and Adolescents' Perspective""]","['High expressed emotion (EE', 'SUCCEAT workshop ( N  = 50) or online intervention']",['EE'],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}]",,0.0360736,"EE significantly decreased in the SUCCEAT groups and the comparison group according to the caregivers', but not the patients' perspective.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Philipp', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Truttmann', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeiler', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Franta', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Wittek', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Schöfbeck', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mitterer', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Mairhofer', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Zanko', 'Affiliation': 'Parkland Clinic, Clinic for Psychosomatic Medicine and Psychotherapy, 34537 Bad Wildungen, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Imgart', 'Affiliation': 'Parkland Clinic, Clinic for Psychosomatic Medicine and Psychotherapy, 34537 Bad Wildungen, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Auer-Welsbach', 'Affiliation': 'Department for Neurology and Child and Adolescent Psychiatry, 9020 Klagenfurt am Wörthersee, Austria.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London WC2R 2LS, UK.""}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wagner', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Andreas F K', 'Initials': 'AFK', 'LastName': 'Karwautz', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9072021']
1230,32610059,Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials.,"The objective of the reported research was to assess the impact of text message (SMS) reminders and their content on cervical screening rates. Women invited for cervical screening in Northwest London from February-October 2015 were eligible. 3133 women aged 24-29 (Study 1) were randomized (1, 1) to 'no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP). 11,405 women aged 30-64 (Study 2), were randomized (1, 1:1:1:1:1:1) to either: no SMS, an SMS without manipulation (SMS), the SMS-PCP, an SMS with a total or proportionate social norm (SMS-SNT or SMS-SNP), or an SMS with a gain-framed or loss-framed message (SMS-GF and SMS-LF). The primary outcome was participation at 18 weeks. In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002). In Study 2 participation was highest in the SMS-PCP (38.4%) and SMS (38.1%) arms compared to control (34.4%), (aOR: 1.19, 95%CI: 1.03-1.38; p = 0.02 and aOR: 1.18, 95%CI: 1.02-1.37; p = 0.03, respectively). The results demonstrate that behavioral SMSs improve cervical screening participation. The message content plays an important role in the impact of SMS. The results from this trial have already been used to designing effective policy for cervical cancer screening. The NHS Cervical Screening Programme started running a London-wide screening SMS campaign which was based on the cervical screening trial described here. According to figures published by Public Health England, after six months attendance increased by 4.8%, which is the equivalent of 13,400 more women being screened at 18 weeks.",2020,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","['3133 women aged 24-29 (Study 1', 'Women invited for cervical screening in Northwest London from February-October 2015 were eligible', '11,405 women aged 30-64 (Study 2']","['behavioral SMSs', ""no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP""]","['cervical screening participation', 'SMS-PCP', 'cervical screening rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]",11405.0,0.199584,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huf', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'King', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, UK.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Richmond', 'Affiliation': 'Breast Cancer Now, 5th Floor Ibex House, 42-47 Minories, London EC3N 1DY, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'West of London Breast Screening Service, Imperial College Healthcare NHS Trust, First Floor, Charing Cross Hospital, Fulham Palace Road, London W6 8RF, UK.'}, {'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Friedman', 'Affiliation': 'Faculty of Public Health, 4 St Andrews Place, London NW1 4LB, UK.'}, {'ForeName': 'Heema', 'Initials': 'H', 'LastName': 'Shukla', 'Affiliation': 'Global Health Capacity, Unit 4, Vista Place, Coy Pond Business Park Ingworth Road, Poole, BH12 1JY, UK.'}, {'ForeName': 'Fu-Min', 'Initials': 'FM', 'LastName': 'Tseng', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Judah', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Scarman Rd, Coventry CV4 7AL, UK. Electronic address: ivo.vlaev@wbs.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106170']
1231,32610608,The Effects of Timing of a Leucine-Enriched Amino Acid Supplement on Body Composition and Physical Function in Stroke Patients: A Randomized Controlled Trial.,"The combination of exercise and nutritional intervention is widely used for stroke patients, as well as frail or sarcopenic older persons. As previously shown, supplemental branched chain amino acids (BCAAs) or protein to gain muscle mass has usually been given just after exercise. This study investigated the effect of the timing of supplemental BCAAs with exercise intervention on physical function in stroke patients. The participants were randomly assigned to two groups based on the timing of supplementation: breakfast ( n  = 23) and post-exercise ( n  = 23). The supplement in the breakfast group was provided at 08:00 with breakfast, and in the post-exercise group it was provided just after the exercise session in the afternoon at 14:00-18:00. In both groups, the exercise intervention was performed with two sessions a day for two months. The main effects were observed in body fat mass ( p  = 0.02, confidence interval (CI): 13.2-17.7), leg press strength ( p  = 0.04, CI: 94.5-124.5), and Berg balance scale ( p  = 0.03, CI: 41.6-52.6), but no interaction with intake timing was observed. Although the effect of the timing of supplementation on skeletal muscle mass was similar in both groups, BCAA intake with breakfast was effective for improving physical performance and decreasing body fat mass. The results suggest that a combination of BCAA intake with breakfast and an exercise program was effective for promoting rehabilitation of post-stroke patients.",2020,"The main effects were observed in body fat mass ( p  = 0.02, confidence interval (CI): 13.2-17.7), leg press strength ( p  = 0.04, CI: 94.5-124.5), and Berg balance scale ( p  = 0.03, CI: 41.6-52.6), but no interaction with intake timing was observed.","['stroke patients, as well as frail or sarcopenic older persons', 'stroke patients', 'Stroke Patients']","['supplemental branched chain amino acids (BCAAs', 'supplemental BCAAs with exercise intervention', 'exercise and nutritional intervention', 'exercise program', 'exercise intervention', 'Leucine-Enriched Amino Acid Supplement', 'supplementation: breakfast ( n  = 23) and post-exercise']","['physical function', 'Body Composition and Physical Function', 'Berg balance scale', 'skeletal muscle mass', 'physical performance and decreasing body fat mass', 'leg press strength', 'body fat mass']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0522278,"The main effects were observed in body fat mass ( p  = 0.02, confidence interval (CI): 13.2-17.7), leg press strength ( p  = 0.04, CI: 94.5-124.5), and Berg balance scale ( p  = 0.03, CI: 41.6-52.6), but no interaction with intake timing was observed.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Tokaichiba 1865, Midori ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Morotomi', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Arinori', 'Initials': 'A', 'LastName': 'Kamono', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Tokaichiba 1865, Midori ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Ishimoto', 'Affiliation': 'Department of Health and Welfare, Health promotion section, Yamato, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Miyazawa', 'Affiliation': 'Rehabilitation Center, Showa University Fujigaoka Rehabilitation Hospital, Fujigaoka 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Kometani', 'Affiliation': 'Rehabilitation Center, Showa University Fujigaoka Rehabilitation Hospital, Fujigaoka 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Rikitaro', 'Initials': 'R', 'LastName': 'Sako', 'Affiliation': 'Rehabilitation Center, Showa University Fujigaoka Rehabilitation Hospital, Fujigaoka 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Kaneko', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Iida', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Kawate', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}]",Nutrients,['10.3390/nu12071928']
1232,32610634,Do Infants at Risk of Developing Cerebral Palsy or Other Neurodevelopmental Disorders Learn What They Practice?,"Through secondary analyses of the Small Step. Randomized Control Trial, we tested the hypothesis that children at risk of developing cerebral palsy (CP) or other neurodevelopmental disorders would learn what they practice, i.e., that they would have a more rapid development within the specifically trained foci (hand use or mobility) of each time period compared to the development rate within the foci not trained at that time. Nineteen infants (6.3 (1.62) months corrected age) included in the Small Step program were assessed at six time points during the intervention. For statistical analysis, general and mixed linear models were used, and the independent variables were the Peabody Developmental Motor scale (stationary, locomotion, grasping and visuomotor sub scales), the Gross Motor Function Measure-66 and the Hand Assessment for Infants. Outcomes related to gross motor function improved significantly more after mobility training than after hand use training, while fine motor function was improved to the same extent following both training types. Significantly higher improvements after the first training period were seen in one out of three outcome measures in both gross and fine motor assessments. The improvements observed were all independent of diagnosis at two years. The concept ""you learn what you practice"" was most clearly confirmed in the case of gross motor development.",2020,Significantly higher improvements after the first training period were seen in one out of three outcome measures in both gross and fine motor assessments.,"['children at risk of developing cerebral palsy (CP) or other neurodevelopmental disorders', 'Nineteen infants (6.3 (1.62) months corrected age) included in the Small Step program']",[],"['gross motor function', 'Peabody Developmental Motor scale (stationary, locomotion, grasping and visuomotor sub scales), the Gross Motor Function Measure-66 and the Hand Assessment for Infants', 'fine motor function']","[{'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0562229', 'cui_str': 'Fine motor functions'}]",19.0,0.0177285,Significantly higher improvements after the first training period were seen in one out of three outcome measures in both gross and fine motor assessments.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Löwing', 'Affiliation': ""Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, SE-171 76 Stockholm, Sweden.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Holmström', 'Affiliation': ""Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, SE-171 76 Stockholm, Sweden.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Almeida', 'Affiliation': 'Stockholm University Brain Imaging Center (SUBIC), Stockholm University, SE-106 91 Stockholm, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Eliasson', 'Affiliation': ""Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, SE-171 76 Stockholm, Sweden.""}]",Journal of clinical medicine,['10.3390/jcm9072041']
1233,32611242,Plant Stanol Esters Reduce LDL (Low-Density Lipoprotein) Aggregation by Altering LDL Surface Lipids: The BLOOD FLOW Randomized Intervention Study.,"OBJECTIVE


Plant stanol ester supplementation (2-3 g plant stanols/d) reduces plasma LDL (low-density lipoprotein) cholesterol concentration by 9% to 12% and is, therefore, recommended as part of prevention and treatment of atherosclerotic cardiovascular disease. In addition to plasma LDL-cholesterol concentration, also qualitative properties of LDL particles can influence atherogenesis. However, the effect of plant stanol ester consumption on the proatherogenic properties of LDL has not been studied. Approach and Results: Study subjects (n=90) were randomized to consume either a plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters for 6 months. Blood samples were taken at baseline and after the intervention. The aggregation susceptibility of LDL particles was analyzed by inducing aggregation of isolated LDL and following aggregate formation. LDL lipidome was determined by mass spectrometry. Binding of serum lipoproteins to proteoglycans was measured using a microtiter well-based assay. LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001. Plant stanol ester-induced decrease in LDL aggregation was more extensive in participants having body mass index<25 kg/m 2 . Decreased LDL aggregation susceptibility was associated with decreased proportion of LDL-sphingomyelins and increased proportion of LDL-triacylglycerols. LDL binding to proteoglycans was decreased in the plant stanol ester group, the decrease depending on decreased serum LDL-cholesterol concentration.
CONCLUSIONS


Consumption of plant stanol esters decreases the aggregation susceptibility of LDL particles by modifying LDL lipidome. The resulting improvement of LDL quality may be beneficial for cardiovascular health. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01315964.",2020,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001.","['participants having body mass', 'Study subjects (n=90']","['plant stanol ester consumption', 'Plant stanol ester', 'Plant stanol ester supplementation', 'plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters', 'plant stanol esters', 'plant stanol ester', 'Plant Stanol Esters']","['plasma LDL (low-density lipoprotein) cholesterol concentration', 'LDL aggregation susceptibility', 'LDL aggregation', 'LDL binding to proteoglycans', 'Decreased LDL aggregation susceptibility', 'serum LDL-cholesterol concentration', 'LDL quality', 'proportion of LDL-triacylglycerols', 'aggregation susceptibility of LDL particles', 'median aggregate size']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872973', 'cui_str': 'plant stanol ester'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0033692', 'cui_str': 'Proteoglycan'}, {'cui': 'C0853085', 'cui_str': 'Low density lipoprotein decreased'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0065191', 'cui_str': 'Low density lipoprotein triglyceride'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",90.0,0.0510065,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001.","[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Ruuth', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Äikäs', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Feven', 'Initials': 'F', 'LastName': 'Tigistu-Sahle', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Reijo', 'Initials': 'R', 'LastName': 'Käkelä', 'Affiliation': 'Molecular and Integrative Biosciences Research Programme, Faculty of Biological and Environmental Sciences (F.T.-S., R.K., K.Ö.), University of Helsinki, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Lindholm', 'Affiliation': 'Finnish Institute of Occupational Health, Helsinki, Finland (H.L.).'}, {'ForeName': 'Piia', 'Initials': 'P', 'LastName': 'Simonen', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology (P.S., H.G.), University of Helsinki, Finland.'}, {'ForeName': 'Petri T', 'Initials': 'PT', 'LastName': 'Kovanen', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gylling', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology (P.S., H.G.), University of Helsinki, Finland.'}, {'ForeName': 'Katariina', 'Initials': 'K', 'LastName': 'Öörni', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.314329']
1234,32398324,"Combination of PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab, in Recurrent Ovarian Cancer: a Proof-of-Concept Phase II Study.","PURPOSE


Preclinical studies suggest PARP inhibition (PARPi) induces immunostimulatory micromilieu in ovarian cancer thus complementing activity of immune checkpoint blockade. We conducted a phase II trial of PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies and blood samples to test this hypothesis.
PATIENTS AND METHODS


In a single-center, proof-of-concept phase II study, we enrolled women aged ≥18 with recurrent ovarian cancer. All patients were immune checkpoint inhibitor-naïve and had measurable disease per RECISTv1.1, ECOG performance status 0-2, and adequate organ and marrow function. Patients received olaparib 300 mg twice daily and durvalumab 1,500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Primary endpoint was overall response rate (ORR). Secondary objectives were safety and progression-free survival (PFS). Translational objectives included biomarker evaluation for relationships with clinical response and immunomodulatory effects by treatment.
RESULTS


Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%),  BRCA  wild-type (77%)] received at least one full cycle of treatment. ORR was 14% [5/35; 95% confidence interval (CI), 4.8%-30.3%]. Disease control rate (PR+SD) was 71% (25/35; 95% CI, 53.7%-85.4%). Treatment enhanced  IFNγ  and  CXCL9/CXCL10  expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes, indicating an immunostimulatory environment. Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
CONCLUSIONS


The PARPi and anti-PD-L1 combination showed modest clinical activity in recurrent ovarian cancer. Our correlative study results suggest immunomodulatory effects by olaparib/durvalumab in patients and indicate that VEGF/VEGFR pathway blockade would be necessary for improved efficacy of the combination.",2020,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
","['recurrent ovarian cancer', 'enrolled women aged ≥18 with recurrent ovarian cancer', 'Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%),  BRCA  wild-type (77', 'Recurrent Ovarian Cancer']","['olaparib 300 mg twice daily and durvalumab', 'PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies', 'PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab', 'PARP inhibition (PARPi']","['IFNγ  and  CXCL9/CXCL10  expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes', 'Disease control rate (PR+SD', 'overall response rate (ORR', 'safety and progression-free survival (PFS', 'ORR', 'elevated VEGFR3 levels', 'Increased IFNγ production']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1567710', 'cui_str': 'PARP1 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3657407', 'cui_str': 'vegfr3 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",35.0,0.174604,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
","[{'ForeName': 'Erika J', 'Initials': 'EJ', 'LastName': 'Lampert', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zimmer', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Padget', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cimino-Mathews', 'Affiliation': 'Department of Pathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Jayakumar R', 'Initials': 'JR', 'LastName': 'Nair', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Hodge', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Nichols', 'Affiliation': 'Clinical Research Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bagheri', 'Affiliation': 'Department of Radiology and Imaging Sciences, Clinical Center, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Interventional Radiology, NIH Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Radke', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Lipkowitz', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Annunziata', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Taube', 'Affiliation': 'Department of Dermatopathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland. leej6@mail.nih.gov.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0056']
1235,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
1236,32615777,Acute differences in blood lipids and inflammatory biomarkers following controlled exposures to cookstove air pollution in the STOVES study.,"Household air pollution is a leading risk factor for morbidity and premature mortality. Numerous cookstoves have been developed to reduce household air pollution, but it is unclear whether such cookstoves meaningfully improve health. In a controlled exposure study with a crossover design, we assessed the effect of pollution emitted from multiple cookstoves on acute differences in blood lipids and inflammatory biomarkers. Participants (n = 48) were assigned to treatment sequences of exposure to air pollution emitted from five cookstoves and a filtered-air control. Blood lipids and inflammatory biomarkers were measured before and 0, 3, and 24 hours after treatments. Many of the measured outcomes had inconsistent results. However, compared to control, intercellular adhesion molecule-1 was higher 3 hours after all treatments, and C-reactive protein and serum amyloid-A were higher 24 hours after the highest treatment. Our results suggest that short-term exposure to cookstove air pollution can increase inflammatory biomarkers within 24 hours.",2020,"However, compared to control, intercellular adhesion molecule-1 was higher 3 hours after all treatments, and C-reactive protein and serum amyloid-A were higher 24 hours after the highest treatment.",['Participants (n\xa0=\xa048'],['exposure to air pollution emitted from five cookstoves and a filtered-air control'],"['blood lipids and inflammatory biomarkers', 'inflammatory biomarkers', 'C-reactive protein and serum amyloid-A', 'Blood lipids and inflammatory biomarkers', 'intercellular adhesion molecule-1']",[],"[{'cui': 'C0476602', 'cui_str': 'Exposure to air pollution'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}]",48.0,0.0426891,"However, compared to control, intercellular adhesion molecule-1 was higher 3 hours after all treatments, and C-reactive protein and serum amyloid-A were higher 24 hours after the highest treatment.","[{'ForeName': 'Ethan S', 'Initials': 'ES', 'LastName': 'Walker', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Fedak', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Good', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'Department of Medicine, University of California San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School , Ann Arbor, MI, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cole-Hunter', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Environmental Public Health Division, United States Environmental Protection Agency, Research Triangle Park , NC, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': ""L'Orange"", 'Affiliation': 'Department of Mechanical Engineering, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Luckasen', 'Affiliation': 'Heart Center of the Rockies , Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehaffy', 'Affiliation': 'Department of Mechanical Engineering, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Shelton', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Statistics, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Volckens', 'Affiliation': 'Department of Mechanical Engineering, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}]",International journal of environmental health research,['10.1080/09603123.2020.1785402']
1237,32618242,Assessment of the Acceptability of Testing and Treatment during a Mass Drug Administration Trial for Malaria in Zambia Using Mixed Methods.,"From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care. Acceptability of the intervention was assessed quantitatively using closed-ended and Likert scale-based questions posed during three household surveys conducted from April to May in 2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls. In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms. Concurrently, 27 focus group discussions and 23 in-depth interviews with 248 participants were conducted on reasons for testing and treatment refusal, reasons for nonadherence, and community perception of the MDA campaign. Results demonstrated that the MDA campaign was highly accepted with more than 99% of respondents stating that they would take treatment if positive for malaria. High acceptability at baseline could be associated with test-and-treat campaigns recently conducted in the study area. There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each. This likely resulted from an intensive community-wide sensitization program that occurred before the first treatment round at each household during community health worker visits.",2020,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","['2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls', 'In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms', 'Malaria in Zambia Using Mixed Methods', 'From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care']",[],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],[],248.0,0.0973838,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","[{'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jennings', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Chilumba', 'Initials': 'C', 'LastName': 'Sikombe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chiyende', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0663']
1238,32618245,"A Longitudinal Cohort to Monitor Malaria Infection Incidence during Mass Drug Administration in Southern Province, Zambia.","Rigorous evidence of effectiveness is needed to determine where and when to apply mass drug administration (MDA) or focal MDA (fMDA) as part of a malaria elimination strategy. The Zambia National Malaria Elimination Centre recently completed a community-randomized controlled trial in Southern Province to evaluate MDA and fMDA for transmission reduction. To assess the role of MDA and fMDA on infection incidence, we enrolled a longitudinal cohort for an 18-month period of data collection including monthly malaria parasite infection detection based on polymerase chain reaction and compared time to first infection and cumulative infection incidence outcomes across study arms using Cox proportional hazards and negative binomial models. A total of 2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis. Infection incidence declined dramatically across all study arms during the period of study, and MDA was associated with reduced risk of first infection (hazards ratio: 0.36; 95% CI: 0.16-0.80) and cumulative infection incidence during the first rainy season (first 5 months of follow-up) (incidence rate ratio: 0.34; 95% CI: 0.12-0.95). No significant effect was found for fMDA or for either arm over the full study period. Polymerase chain reaction infection status at baseline was strongly associated with follow-up infection. The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.",2020,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"['Southern Province, Zambia', '2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis']","['MDA', 'MDA and fMDA']","['Infection incidence', 'cumulative infection incidence', 'Polymerase chain reaction infection status', 'reduced risk of first infection']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2026.0,0.0828922,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Mulenga C', 'Initials': 'MC', 'LastName': 'Mwenda', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Mambwe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Chishimba', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Conceptor', 'Initials': 'C', 'LastName': 'Mulube', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bridges', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0657']
1239,32618247,"Impact of Four Rounds of Mass Drug Administration with Dihydroartemisinin-Piperaquine Implemented in Southern Province, Zambia.","Over the past decade, Zambia has made substantial progress against malaria and has recently set the ambitious goal of eliminating by 2021. In the context of very high vector control and improved access to malaria diagnosis and treatment in Southern Province, we implemented a community-randomized controlled trial to assess the impact of four rounds of community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP) implemented between December 2014 and February 2016. The mass treatment campaigns achieved relatively good household coverage (63-79%), were widely accepted by the community (ranging from 87% to 94%), and achieved very high adherence to the DHAP regimen (81-96%). Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial. Children in areas of lower transmission (< 10% prevalence at baseline) that received four MDA rounds had a 72% (95% CI = 12-91%) reduction in malaria parasite prevalence as compared with those with the standard of care without any mass treatment. Mass drug administration consistently had the largest short-term effect size across study end points in areas of lower transmission following the first two MDA rounds. In the context of achieving very high vector control coverage and improved access to diagnosis and treatment for malaria, our results suggest that MDA should be considered for implementation in African settings for rapidly reducing malaria outcomes in lower transmission settings.",2020,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","['Southern Province', 'Southern Province, Zambia']","['community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP', 'Dihydroartemisinin-Piperaquine', 'MDA']","['malaria parasite prevalence', 'overall parasite prevalence']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0868305,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chalwe', 'Affiliation': 'Institute for Medical Research and Training, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kooma', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Mulakwa', 'Initials': 'M', 'LastName': 'Kamuliwo', 'Affiliation': 'Zambia Ministry of Health, Southern Provincial Health Office, Choma, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Kammerle', 'Initials': 'K', 'LastName': 'Schneider', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0659']
1240,32618267,"Adherence to Mass Drug Administration with Dihydroartemisinin-Piperaquine and  Plasmodium falciparum  Clearance in Southern Province, Zambia.","Mass drug administration (MDA) with artemisinin combination therapy is a potentially useful tool for malaria elimination programs, but its success depends partly on drug effectiveness and treatment coverage in the targeted population. As part of a cluster-randomized controlled trial in Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with dihydroartemisinin-piperaquine (DHAp), sub-studies were conducted investigating population drug adherence rates and effectiveness of DHAp as administered in clearing  Plasmodium falciparum  infections following household mass administration. Adherence information was reported for 181,534 of 336,821 DHAp (53.9%) treatments administered during four rounds of MDA/fMDA, of which 153,197 (84.4%) reported completing the full course of DHAp. The proportion of participants fully adhering to the treatment regimen differed by MDA modality (MDA versus fMDA), RDT status, and whether the first dose was observed by those administering treatments. Among a subset of participants receiving DHAp and selected for longitudinal follow-up, 58 were positive for asexual-stage  P. falciparum  infection by microscopy at baseline. None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia. For those with longer term follow-up, one participant was positive 47 days after treatment, and two additional participants were positive after 69 days, although these two were determined to be new infections by genotyping. High completion of a 3-day course of DHAp and parasite clearance in the context of household MDA are promising as Zambia's National Malaria Programme continues to weigh appropriate interventions for malaria elimination.",2020,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"['Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with', 'Southern Province, Zambia']","['Dihydroartemisinin-Piperaquine', 'DHAp', 'artemisinin combination therapy', 'dihydroartemisinin-piperaquine (DHAp']","['Adherence information', 'MDA modality (MDA versus fMDA), RDT status', 'slide positive for asexual-stage parasitemia']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}]",,0.179382,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital Grounds, Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Daniels', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, Massachusetts.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Volkman', 'Affiliation': 'Simmons University, Boston, Massachusetts.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0667']
1241,32618279,"Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.","BACKGROUND


The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules.
METHODS


We did a single-centre, double-blind, randomised controlled, phase 1 trial in healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA. Participants were sequentially enrolled into one of three groups: ZPIV given at weeks 0 and 4 (standard regimen), weeks 0 and 2 (accelerated regimen), or week 0 alone (single-dose regimen). Within each group, participants were randomly assigned using a computer-generated randomisation schedule to receive an intramuscular injection of 5 μg ZPIV or saline placebo, in a ratio of 5:1. The sponsor, clinical staff, investigators, participants, and laboratory personnel were masked to treatment assignment. The primary endpoint was safety up to day 364 after final dose administration, and secondary endpoints were proportion of participants with positive humoral immune responses (50% microneutralisation titre [MN 50 ] ≥100) and geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level observed for an individual participant across all timepoints) and week 28. All participants who received at least one dose of ZPIV or placebo were included in the safety population; the analysis of immunogenicity at observed peak included all participants who received at least one dose of ZPIV or placebo and had any adverse events or immunogenicity data after dosing. The week 28 immunogenicity analysis population consisted of all participants who received ZPIV or placebo and had immunogenicity data available at week 28. This trial is registered with ClinicalTrials.gov, NCT02937233.
FINDINGS


Between Dec 8, 2016, and May 17, 2017, 12 participants were enrolled into each group and then randomly assigned to vaccine (n=10) or placebo (n=2). There were no serious or grade 3 treatment-related adverse events. The most common reactions among the 30 participants who received the vaccine were injection-site pain (24 [80%]), fatigue (16 [53%]), and headache (14 [46%]). A positive response at observed peak titre was detected in all participants who received ZPIV via the standard regimen, in eight (80%) of ten participants who received ZPIV via the accelerated regimen, and in none of the ten participants who received ZPIV via the single-dose regimen. The geometric mean of all individual participants' observed peak values was 1153·9 (95% CI 455·2-2925·2) in the standard regimen group, 517·7 (142·9-1875·6) in the accelerated regimen group, and 6·3 (3·7-10·8) in the single-dose regimen group. At week 28, a positive response was observed in one (13%) of eight participants who received ZPIV via the standard regimen and in no participant who received ZPIV via the accelerated (n=7) or single-dose (n=10) regimens. The geomteric mean titre (GMT) at this timepoint was 13·9 (95% CI 3·5-55·1) in the standard regimen group and 6·9 (4·0-11·9) in the accelerated regimen group; antibody titres were undetectable at 28 weeks in participants who received ZPIV via the single-dose regimen. For all vaccine schedules, GMTs peaked 2 weeks after the final vaccination and declined to less than 100 by study week 16. There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
INTERPRETATION


ZPIV was safe and well tolerated in humans up to 52 weeks of follow-up. ZPIV immunogenicity required two doses and was not durable. Additional studies of ZPIV to optimise dosing schedules are ongoing.
FUNDING


The Henry M Jackson Foundation for the Advancement of Military Medicine.",2020,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","['healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA']","['intramuscular injection of 5 μg ZPIV or saline placebo', 'ZPIV or placebo', 'Zika purified inactivated virus vaccine', 'vaccine', 'ZPIV', 'placebo']","['headache', 'Safety and immunogenicity', 'fatigue', 'ZPIV immunogenicity', 'geomteric mean titre (GMT', 'injection-site pain', 'adverse events or immunogenicity data', 'safety and immunogenicity', 'proportion of participants with positive humoral immune responses', 'serious or grade 3 treatment-related adverse events', ' antibody titres', 'geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level', 'positive response', 'peak titre', 'observed peak GMTs']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.542669,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA; Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Moseley', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30085-2']
1242,32618695,Acute Kidney Injury in Acute Ischemic Stroke Patients in Clinical Trials.,"OBJECTIVES


Acute ischemic stroke patients are at risk of acute kidney injury due to volume depletion, contrast exposure, and preexisting comorbid diseases. We determined the occurrence rate and identified predictors associated with acute kidney injury in acute ischemic stroke patients.
SETTING


Multiple specialized ICUs within academic medical centers.
DESIGN


Post hoc analysis of pooled data from prospective randomized clinical trials.
PATIENTS


Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset.
INTERVENTIONS


IV recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo.
MEASUREMENTS AND MAIN RESULTS


Serum creatinine levels from baseline and within day 5 or discharge were used to classify acute kidney injury classification into stages. Any increase in serum creatinine was seen in 697 (36.1%) and acute kidney injury was seen in 68 (3.5%) of 1,931 patients with acute ischemic stroke. Severity of acute kidney injury was grade I, II, and III in 3.1%, 0.4%, and 0.05% patients, respectively. Patients with albumin (5.5% compared with 2.6%; p = 0.001), preexisting hypertension (4.3% compared with 1.5%; p = 0.0041), and preexisting renal disease (9.1% compared with 3.0%; p < 0.0001) had higher risk of acute kidney injury. The risk of acute kidney injury was lower between those who either underwent CT angiography (2.0% compared with 4.7%; p = 0.0017) or endovascular treatment (1.6% compared with 4.2%; p = 0.0071). In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury. The risk of death was significantly higher among patients with acute kidney injury (odds ratio, 2.7; 95% CI, 1.4-4.9) after adjusting for age and National Institutes of Health Stroke Scale score strata.
CONCLUSIONS


The occurrence rate of acute kidney injury in acute ischemic stroke patients was low and was not higher in patients who underwent CT angiogram or those who received endovascular treatment. Occurrence of acute kidney injury increased the risk of death within 3 months among acute ischemic stroke patients.",2020,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","['1,931 patients with acute ischemic stroke', 'Multiple specialized ICUs within academic medical centers', 'Acute Ischemic Stroke Patients', 'acute ischemic stroke patients', 'Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset', 'Acute ischemic stroke patients']","['CT angiography', 'recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo', 'CT angiogram']","['preexisting renal disease', 'risk of death', 'serum creatinine', 'renal disease', 'Serum creatinine levels', 'acute kidney injury', 'preexisting hypertension', 'risk of acute kidney injury']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1931.0,0.150194,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Hunain', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Werdah', 'Initials': 'W', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Syed H', 'Initials': 'SH', 'LastName': 'Naqvi', 'Affiliation': 'Department of Medicine, University of Missouri, Columbia, MO.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of Missouri, Columbia, MO.'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Premkumar N', 'Initials': 'PN', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Siddiq', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Missouri, Columbia, MO.'}, {'ForeName': 'Brandi R', 'Initials': 'BR', 'LastName': 'French', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Camilo R', 'Initials': 'CR', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}]",Critical care medicine,['10.1097/CCM.0000000000004464']
1243,32684359,Improving Colorectal Cancer Screening in a Rural Setting: A Randomized Study.,"INTRODUCTION


Colorectal cancer screening has been shown to prevent or detect early colorectal cancer and reduce mortality; yet, adherence to screening recommendations remains low, particularly in rural settings.
STUDY DESIGN


RCT.
SETTING/PARTICIPANTS


Adults (n=7,812) aged 50-75 years and due for colorectal cancer screening in a largely rural health system were randomly assigned to either the intervention (n=3,906) or the control (n=3,906) group in September 2016, with analysis following through 2018.
INTERVENTION


A mailed motivational messaging screening reminder letter with an option to call and request a free at-home fecal immunochemical screening test (intervention) or the standard invitation letter detailing that the individual was due for screening (control). Multifaceted motivational messaging emphasized colorectal cancer preventability and the ease and affordability of screening, and communicated a limited supply of test kits.
MAIN OUTCOME MEASURES


Colorectal cancer screening participation within 6 months after mailed invitation was ascertained from the electronic medical record.
RESULTS


Colorectal cancer screening participation was significantly improved in the intervention (30.1%) vs the usual care control group (22.5%; p<0.001). Individuals randomized to the intervention group had 49% higher odds of being screened over follow-up than those randomized to the control group (OR=1.49, 95% CI=1.34, 1.65). A total of 13.2 screening invitations were needed to accomplish 1 additional screening over the usual care. Of the 233 fecal immunochemical test kits mailed to participants, 154 (66.1%) were returned, and 18 (11.7%) tested positive.
CONCLUSIONS


A mailed motivational messaging letter with a low-cost screening alternative increased colorectal cancer screening in this largely rural community with generally poor adherence to screening recommendations. Mailed colorectal cancer screening reminders using motivational messaging may be an effective method for increasing screening and reducing rural colorectal cancer disparities.",2020,"RESULTS


Colorectal cancer screening participation was significantly improved in the intervention (30.1%) vs the usual care control group (22.5%; p<0.001).","['Adults (n=7,812', 'aged 50-75 years and due for colorectal cancer screening in a largely rural health system']",['motivational messaging screening reminder letter with an option to call and request a free at-home fecal immunochemical screening test (intervention) or the standard invitation letter detailing that the individual was due for screening (control'],['Colorectal cancer screening participation'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",7812.0,0.0487801,"RESULTS


Colorectal cancer screening participation was significantly improved in the intervention (30.1%) vs the usual care control group (22.5%; p<0.001).","[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hirko', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, Michigan. Electronic address: khirko@epi.msu.edu.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Lennon', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, Michigan; Division of Public Health, College of Human Medicine, Michigan State University, Flint, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Miller', 'Affiliation': 'Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Jimbo', 'Affiliation': 'Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan; Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Leibfritz', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}, {'ForeName': 'Suzanne J', 'Initials': 'SJ', 'LastName': 'Knoff', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Janney', 'Affiliation': 'Department of Psychiatry, College of Human Medicine West Michigan, Michigan State University, Grand Rapids, Michigan; Pine Rest Christian Mental Health Services, Grand Rapids, Michigan.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Berg', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.019']
1244,32619609,"Evaluating the structural effects of intra-articular sprifermin on cartilage and non-cartilaginous tissue alterations, based on sqMRI assessment over 2 years.","OBJECTIVE


Sprifermin (recombinant human fibroblast growth factor-18), a potential disease-modifying osteoarthritis (OA) drug, demonstrated dose-dependent effects on femorotibial cartilage thickness (by quantitative magnetic resonance imaging [MRI]) in the phase II FORWARD study. This post-hoc analysis evaluated the potential effects of sprifermin on several articular structures in the whole joint over 24 months using semi-quantitative MRI assessment.
DESIGN


Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee were randomized (1:1:1:1:1) to receive three double-blinded, once-weekly, intra-articular injections of sprifermin 30 μg or 100 μg or placebo every 6 (q6mo) or 12 months. 1.5- or 3 T MRIs were read using the Whole-Organ Magnetic Resonance Imaging Score (WORMS) system at baseline and 24 months. Change from baseline at 24 months on compartment and/or whole knee level was assessed for cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches. Menisci, Hoffa-synovitis, and effusion-synovitis were also evaluated for worsening.
RESULTS


549 patients were included. Dose-dependent treatment effects from baseline to 24 months were observed on cartilage morphology (sprifermin 100 μg q6mo vs placebo; mean DSM (95% confidence interval [CI]) -0.6 (-1.5, 0.2); less cartilage worsening) in the entire knee and BMLs sprifermin 100 μg q6mo vs placebo; mean DSM (95% CI) -0.2 (-0.5, 0.1) in the patellofemoral compartment. No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
CONCLUSIONS


Positive effects associated with sprifermin were observed for cartilage morphology changes, and BML improvement. There were no meaningful negative or positive effects associated with sprifermin in the other joint tissues examined.",2020,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
","['549 patients were included', 'Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee']","['Sprifermin (recombinant human fibroblast growth factor-18', 'sprifermin 30 μg or 100 μg or placebo', 'placebo']","['Menisci, Hoffa-synovitis, and effusion-synovitis', 'cartilage morphology', 'osteophytes, menisci, Hoffa-synovitis or effusion-synovitis', 'cartilage morphology changes, and BML improvement', 'femorotibial cartilage thickness', 'cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C1432638', 'cui_str': 'fibroblast growth factor 18, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0224498', 'cui_str': 'Meniscus structure of joint'}, {'cui': 'C0268203', 'cui_str': 'Liposynovitis prepatellaris'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",549.0,0.160466,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
","[{'ForeName': 'F W', 'Initials': 'FW', 'LastName': 'Roemer', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; University of Erlangen-Nuremberg, Erlangen, Germany. Electronic address: froemer@bu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kraines', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA, a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aydemir', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA, a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wax', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA, a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Crema', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; Institute of Sports Imaging, French National Institute of Sports, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; Department of Radiology, VA Boston Healthcare System, West Roxbury, MA, 02132, USA.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.05.015']
1245,32619656,Endoscopic debridement for non-insertional Achilles tendinopathy with and without platelet-rich plasma.,"BACKGROUND


When non-operative management fails to improve symptoms in patients with non-insertional Achilles tendinopathy, surgery may be required. Various open and endoscopic techniques have been proposed, and platelet-rich plasma (PRP) injections have been proposed as an adjunct to aid tendon healing.
METHODS


Thirty-six patients with mid-portion Achilles tendinopathy were randomized to undergo endoscopic debridement alone (n = 19) or in combination with intraoperative PRP application (n = 17). Clinical outcome measures included the Visual Analogue Scale for pain, function, and satisfaction and the Victorian Institute of Sports Assessment - Achilles (VISA-A) questionnaire. Patients were followed-up at 6 weeks, 3 months, 6 months, and 12 months after surgery. An MRI examination at 3 and 12 months was used to assess signal alterations within the tendon.
RESULTS


Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups. Tendon diameter increased at 3 months and decreased at 12 months. The tendinopathy area increased at 3 months and decreased at 12 months below baseline level in both groups. There was no significant difference between the groups regarding the MRI parameters. Nodular thickening and MRI-detected signal alteration persisted after surgery, with no association between imaging and clinical outcome. Five minor complications were reported: 2 in the PRP group and 3 in the control group.
CONCLUSION


Endoscopic debridement of the Achilles tendon improved clinical outcomes in patients with mid-portion tendinopathy. The addition of PRP did not improve outcomes compared to debridement alone. MRI parameters showed no association with clinical outcomes.",2020,"Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups.","['patients with mid-portion tendinopathy', 'patients with non-insertional Achilles tendinopathy', 'Thirty-six patients with mid-portion Achilles tendinopathy']","['Endoscopic debridement', 'PRP', 'endoscopic debridement alone (n\u202f=\u202f19) or in combination with intraoperative PRP application']","['clinical outcomes', 'MRI parameters', 'Tendon diameter', 'Visual Analogue Scale (VAS) for pain, function and satisfaction and the VISA-A questionnaire (Victorian Institute of Sports Assessment - Achilles', 'tendinopathy area', 'Nodular thickening and MRI-detected signal alteration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C3838916', 'cui_str': 'Non-insertional Achilles tendinopathy'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",36.0,0.0569791,"Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups.","[{'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Thermann', 'Affiliation': 'HKF-International Center for Hip, Foot and Knee Surgery, Bismarckstraße 9-15, 69115 Heidelberg, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'HKF-International Center for Hip, Foot and Knee Surgery, Bismarckstraße 9-15, 69115 Heidelberg, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Gougoulias', 'Affiliation': 'Footsurgery Clinic, 54631 Thessaloniki, Greece.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Cipollaro', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno 89100, Italy; Department of Medicine, Surgery and Dentistry, University of Salerno, Via S. Allende, 84081 Baronissi (SA), Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno 89100, Italy; Department of Medicine, Surgery and Dentistry, University of Salerno, Via S. Allende, 84081 Baronissi (SA), Italy; Centre for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, Mile End Hospital, 275 Bancroft Road, London E1 4DG, Queen Mary University of London, London, UK; School of Pharmacy and Bioengineering, Keele University Faculty of Medicine, Thornburrow Drive, Stoke on Trent, ST4 7QB, UK. Electronic address: n.maffulli@qmul.ac.uk.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.06.012']
1246,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
1247,32619832,Definitive chemoradiotherapy plus cetuximab for cancer in the oesophagus or gastro-oesophageal junction.,"BACKGROUND


Chemoradiotherapy is standard treatment for localized oesophageal cancer unsuitable for surgery. We aimed to evaluate the efficacy of cetuximab in combination with chemoradiotherapy.
METHODS


This non-randomised multicentre phase II trial recruited patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery. Chemotherapy was three 21-day cycles of fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg/m 2, cycle 2-3:85 mg/m 2). Radiotherapy was 50Gy in 2Gy/fraction, 5 days a week, concurrent with cycle 2 and 3 and weekly cetuximab. The primary objective was loco-regional control at one year.
RESULTS


52 patients were included. 51 were eligible for toxicity and survival analysis and 46 for recurrence analysis. Full radiotherapy dose was delivered to 80%, 75% received all three cycles of chemotherapy and 75% received four or more doses of cetuximab. The most common related grade III-IV adverse events were gastro-intestinal(16), hypersensitivity(6) and infection(5). There were two drug-related deaths. Within six months from the end of treatment, six patients died from complications from fistulas. The loco-regional control rate at one year was 47.3%(95%CI 30.9%-62.1%). Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
CONCLUSIONS


Oxaliplatin and fluorouracil given concurrent with radiotherapy and cetuximab had an acceptable safety profile and showed a clinical response in patients with locoregionally advanced oesophageal cancer unsuitable for surgery. However, the primary end-point was not met, and the addition of cetuximab to definitive chemoradiotherapy cannot be recommended.",2020,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","['localized oesophageal cancer unsuitable for surgery', 'cancer in the oesophagus or gastro-oesophageal junction', 'patients with locoregionally advanced oesophageal cancer unsuitable for surgery', 'patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery', '52 patients were included']","['radiotherapy and cetuximab', 'Chemotherapy', 'Definitive chemoradiotherapy plus cetuximab', 'Oxaliplatin and fluorouracil', 'Full radiotherapy', 'cetuximab', 'Chemoradiotherapy', 'fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg', 'Radiotherapy']","['toxicity and survival analysis', 'Overall survival', 'loco-regional control at one year', 'loco-regional control rate']","[{'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",52.0,0.16028,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","[{'ForeName': 'Gabriella Alexandersson', 'Initials': 'GA', 'LastName': 'von Döbeln', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden. Electronic address: gabriella.alexandersson-vondobeln@sll.se.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Wagenius', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Holtved', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anne-Birgitte', 'Initials': 'AB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Oncology, Oslo University hospital, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences Intervention and Technology Karolinska Institutet Division of Upper Abdominal Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baeksgaard', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100187']
1248,32621071,"Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.","BACKGROUND


Aripiprazole lauroxil (AL) is a long-acting injectable antipsychotic approved for treatment of schizophrenia in adults. Approved AL doses and dosing regimens include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks (q6wk), as well as the most recently approved dose, 1064 mg, administered every 2 months.
OBJECTIVE


Pharmacokinetics, safety, and tolerability of an AL regimen with a dose interval of every 2 months (1064 mg) were compared with two other regimens available as monthly and q6wk options.
METHODS


This study evaluated pharmacokinetics of AL given at a higher dosage strength (1064 mg) and at a longer dose interval (every 8 weeks [q8wk]) than previously studied. Patients with schizophrenia or schizoaffective disorder entering this 44-week, phase I, open-label, multicenter study had no recent exposure to aripiprazole and were maintained on other oral antipsychotics throughout the study. Patients were randomized to one of three AL dose regimens for 24 weeks (four 1064-mg injections [q8wk], five 882-mg injections [q6wk], or seven 441-mg injections [q4wk], with the last AL exposure at week 24). Oral aripiprazole was prohibited. Patients were followed for an additional 20 weeks to assess terminal aripiprazole plasma concentrations and ongoing safety. Plasma concentration samples were obtained at regular intervals to provide pharmacokinetic data for the duration of AL exposure and to measure persistence of plasma aripiprazole concentrations after AL discontinuation.
RESULTS


Eligible patients received AL 1064 mg q8wk (n = 35), 882 mg q6wk (n = 34), or 441 mg q4wk (n = 35). Overall, 103/104 (99.0%) patients were taking concomitant non-aripiprazole oral antipsychotic medications during the study. All three AL dose regimens provided continuous exposure to aripiprazole. Mean aripiprazole concentrations from the 1064-mg q8wk regimen were comparable to the 882-mg q6wk regimen and higher than the 441-mg q4wk regimen. Overall incidence by group of any adverse events (AEs) throughout the study was 68.6% (1064 mg q8wk), 50.0% (882 mg q6wk), and 65.7% (441 mg q4wk). The most common AE across regimens was injection-site pain (range 8.6%-11.4%). Serious AEs were reported by eight patients (all but one [increased psychosis in one patient, 441-mg q4wk group] considered unrelated to study drug). Discontinuations due to AEs were reported for 2.9%, 11.8%, and 5.7% of patients receiving the 8-, 6-, and 4-week regimens, respectively. AEs of akathisia, dyskinesia, and dystonia occurred in 2.9%, 8.6%, and 5.7% of patients in the 1064-mg q8wk group, 8.8%, 0%, and 2.9% in the 882-mg q6wk group, and 8.6%, 0%, and 0% in the 441-mg q4wk group, respectively.
CONCLUSIONS


AL 1064 mg q8wk provided continuous exposure to aripiprazole throughout the 8-week dosing interval and had a safety profile consistent with the 4- and 6-week regimens. These findings were used to support FDA approval of the 1064-mg dose administered every 2 months.
REGISTRATION


Clinicaltrials.gov: NCT02320032.",2020,"Overall incidence by group of any adverse events (AEs) throughout the study was 68.6% (1064 mg q8wk), 50.0% (882 mg q6wk), and 65.7% (441 mg q4wk).","['schizophrenia in adults', 'Patients with schizophrenia or schizoaffective disorder entering this 44-week, phase I, open-label, multicenter study had no recent exposure to']","['Aripiprazole lauroxil (AL', 'Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil', 'Oral aripiprazole', 'aripiprazole']","['Pharmacokinetics, Safety, and Tolerability', 'terminal aripiprazole plasma concentrations and ongoing safety', 'akathisia, dyskinesia, and dystonia', 'Plasma concentration samples', 'plasma aripiprazole concentrations', 'Mean aripiprazole concentrations', 'Pharmacokinetics, safety, and tolerability']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0184254,"Overall incidence by group of any adverse events (AEs) throughout the study was 68.6% (1064 mg q8wk), 50.0% (882 mg q6wk), and 65.7% (441 mg q4wk).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA. pjweiden@gmail.com.'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'von Moltke', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wehr', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Marjie', 'Initials': 'M', 'LastName': 'Hard', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Marandi', 'Affiliation': 'Radiant Clinical Research, Cerritos, CA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Walling', 'Affiliation': 'CNS Network, LLC, Garden Grove, CA, USA.'}]",CNS drugs,['10.1007/s40263-020-00745-1']
1249,32622225,The impact of adult trauma triage training on decision-making skills and accuracy of triage decision at emergency departments in Malaysia: A randomized control trial.,"INTRODUCTION


Patients who visit emergency departments need to undergo a precise assessment to determine their priority and accurate triage category to ensure they receive the right treatment.
AIM


To identify the effect of triage training on the skills and accuracy of triage decisions for adult trauma patients.
METHOD


A randomized controlled trial design was conducted in ten emergency department of public hospitals. A total of 143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n = 74) and the intervention group (n = 69). The skill and accuracy of triage decisions were measured two weeks and four weeks after the intervention group were exposed to the intervention.
RESULTS


There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31. Concerning the accuracy of triage decisions, the effect was significantly different between the control group and the intervention group p < 0.001, η 2 partial  = 0.66 across time.
CONCLUSION


The triage training improved the skills of the participants and the accuracy of triage decision-making across time.",2020,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31.","['emergency departments in Malaysia', 'Patients who visit emergency departments', 'ten emergency department of public hospitals', '143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n\xa0=\xa074) and the intervention group (n\xa0=\xa069', 'adult trauma patients']","['triage training', 'adult trauma triage training']","['skill and accuracy of triage decisions', 'skill of triage decision-making']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0557516', 'cui_str': 'Medical officer'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",143.0,0.0515258,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31.","[{'ForeName': 'Siti Aishah', 'Initials': 'SA', 'LastName': 'Ghazali', 'Affiliation': 'School of Health Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia; Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: schah@usm.my.'}, {'ForeName': 'Khatijah Lim', 'Initials': 'KL', 'LastName': 'Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: katlim@um.edu.my.'}, {'ForeName': 'Foong Ming', 'Initials': 'FM', 'LastName': 'Moy', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: moyfm@ummc.edu.my.'}, {'ForeName': 'Rashidi', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Department of Emergency Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: rashidi@ummc.edu.my.'}, {'ForeName': 'Emni Omar Daw', 'Initials': 'EOD', 'LastName': 'Hussin', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.'}]",International emergency nursing,['10.1016/j.ienj.2020.100889']
1250,32468267,Endometrial Scratching Effect on Clinical Pregnancy Rates in Patients Undergoing Egg Donor In Vitro Fertilization Cycles: the ENDOSCRATCH Randomized Clinical Trial (NCT03108157).,"The potential benefit of endometrial scratching (ES) on embryo implantation is still a controversial subject. At present, the single retrospective study in egg donor IVF cycles concluded that ES has no beneficial effect. Our objective was to determine if there are differences in clinical pregnancy rates (CPR) in egg donor cycles when an ES is performed. This is a randomized controlled trial (RCT) in egg donor IVF patients conducted at ProcreaTec Fertility Center in Madrid. Three hundred fifty-two patients were included in total. One hundred sixty-one patients completed the protocol in group A and 172 patients in group B. Patients allocated to group A received an ES in the luteal phase of the cycle preceding the embryo transfer cycle. Group B patients did not receive any intervention. Primary outcome of this RCT was CPR. Secondary outcomes were implantation (IR), miscarriage (MR), ongoing pregnancy (OPR), multiple pregnancy (MulPR), and live birth rates (LBR). CPR was 104 of 161 (64.6%) in group A and 102 of 172 (59.3%) in group B (RR 1.09, 95% confidence interval (CI) (0.92-1.29); p = 0.378). OPR, MR, MulPR, and LBR were also comparable. No major complications were detected after ES and pregnancy complications were comparable. Our results show that there is no beneficial role of ES in egg donor IVF cycles, considering these patients as the ideal model as they share homogeneous embryo quality and endometrial preparation protocols. This trial was registered on April 5, 2017, as the ENDOSCRATCH trial (NCT03108157).",2020,No major complications were detected after ES and pregnancy complications were comparable.,"['Patients Undergoing Egg Donor', 'egg donor IVF patients conducted at ProcreaTec Fertility Center in Madrid', 'Three hundred fifty-two patients were included in total']","['ES', 'endometrial scratching (ES']","['pregnancy complications', 'Clinical Pregnancy Rates', 'CPR', 'OPR, MR, MulPR, and LBR', 'clinical pregnancy rates (CPR', 'major complications', 'implantation (IR), miscarriage (MR), ongoing pregnancy (OPR), multiple pregnancy (MulPR), and live birth rates (LBR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029975', 'cui_str': 'Egg donor'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]","[{'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",352.0,0.354115,No major complications were detected after ES and pregnancy complications were comparable.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Izquierdo Rodriguez', 'Affiliation': 'ProcreaTec Fertility Center, Manuel de Falla 6, 28036, Madrid, Spain. endoscratchtrial@gmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'de la Fuente Bitaine', 'Affiliation': 'Human Reproduction Unit, Department of Obstetrics and Gynecology, University Hospital 12 de Octubre, Avda. Andalucia s/n, Madrid, Spain.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Spies', 'Affiliation': 'ProcreaTec Fertility Center, Manuel de Falla 6, 28036, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lora', 'Affiliation': 'Clinical Research Unit (imas12-CIBERESP), University Hospital 12 de Octubre, Avda. Andalucia s/n, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Galindo', 'Affiliation': 'Fetal Medicine Unit - Maternal and Child Health and Development Network (Red SAMID-RD12/0026/0016), Department of Obstetrics and Gynecology, University Hospital 12 de Octubre, 12 de Octubre Research Institute (imas12), Complutense University of Madrid, Avda. Andalucia s/n, Madrid, Spain.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00204-8']
1251,32471973,The neuropeptide substance P regulates aldosterone secretion in human adrenals.,"Aldosterone, produced by the adrenals and under the control of plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure. Here we report that the neuropeptide substance P (SP) released by intraadrenal nerve fibres, stimulates aldosterone secretion via binding to neurokinin type 1 receptors (NK1R) expressed by aldosterone-producing adrenocortical cells. The action of SP is mediated by the extracellular signal-regulated kinase pathway and involves upregulation of steroidogenic enzymes. We also conducted a prospective proof-of-concept, double blind, placebo-controlled clinical trial aimed to investigate the impact of the NK1R antagonist aprepitant on aldosterone secretion in healthy male volunteers (EudraCT: 2008-003367-40, ClinicalTrial.gov: NCT00977223). Participants received during two 7-day treatment periods aprepitant (125 mg on the 1 st  day and 80 mg during the following days) or placebo in a random order at a 2-week interval. The primary endpoint was plasma aldosterone levels during posture test. Secondary endpoints included basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH during the three different stimulatory tests. The safety of the treatment was assessed on the basis of serum transaminase measurements on days 4 and 7. All pre-specified endpoints were achieved. Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture. These results indicate that the autonomic nervous system exerts a direct stimulatory tone on mineralocorticoid synthesis through SP, and thus plays a role in the maintenance of hydromineral homeostasis. This regulatory mechanism may be involved in aldosterone excess syndromes.",2020,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"['healthy male volunteers (EudraCT', 'human adrenals']","['NK1R antagonist aprepitant', 'Aldosterone', 'neuropeptide substance P (SP', 'placebo']","['plasma aldosterone levels', 'aldosterone secretion', 'aldosterone production', 'plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure', 'basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}]","[{'cui': 'C0038581', 'cui_str': 'Neurokinin alpha'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]",,0.0620632,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Wils', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Duparc', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Cailleux', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Antoine-Guy', 'Initials': 'AG', 'LastName': 'Lopez', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Guiheneuf', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutelet', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hadrien-Gaël', 'Initials': 'HG', 'LastName': 'Boyer', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubessy', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Saloua', 'Initials': 'S', 'LastName': 'Cherifi', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cauliez', 'Affiliation': 'Rouen University Hospital, Department of Biochemistry, 76000, Rouen, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Gobet', 'Affiliation': 'Rouen University Hospital, Department of Pathology, 76000, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Defortescu', 'Affiliation': 'Rouen University Hospital, Department of Urology, 76000, Rouen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Ménard', 'Affiliation': 'Rouen University Hospital, Department of Biostatistics, 76000, Rouen, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Louiset', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lefebvre', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France. herve.lefebvre@chu-rouen.fr.'}]",Nature communications,['10.1038/s41467-020-16470-8']
1252,32473378,Annexin A1 is a Potential Novel Biomarker of Congestion in Acute Heart Failure.,"OBJECTIVES


This study sought to identify the role of annexin A1 (AnxA1) as a congestion marker in acute heart failure (AHF) and to identify its putative role in predicting clinical outcomes.
BACKGROUND


AnxA1 is a protein that inhibits inflammation following ischemia-reperfusion injury in cardiorenal tissues. Because AHF is a state of tissue hypoperfusion, we hypothesized that plasma AnxA1 levels are altered in AHF.
METHODS


In the Renal Optimization Strategies Evaluation (ROSE) trial, patients hospitalized for AHF with kidney injury were randomized to receive dopamine, nesiritide, or placebo for 72 hours in addition to diuresis. In a subanalysis, plasma AnxA1 levels were measured at baseline and at 72 hours in 275 patients. Participants were divided into 3 tertiles based on their baseline AnxA1 levels.
RESULTS


The prevalence of peripheral edema 2+ increased with increasing AnxA1 levels (P < .007). Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (P< .05). Patients with a congestion score of 4 had a mean baseline AnxA1 level 8.63 units higher than those with a congestion score of 0 (P = .03). Patients in tertiles 2 and 3 were twice as likely to experience creatinine elevation as patients in tertile 1 (P = .03). Patients in tertiles 2 and 3 were at a higher risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality (P < .05).
CONCLUSIONS


Among patients hospitalized for AHF with impaired kidney function, elevated AnxA1 levels are associated with worse congestion, higher risk for further creatinine elevation, and higher rates of 60-day morbidity or all-cause mortality and 180-day all-cause mortality.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01132846.",2020,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).",['patients hospitalized for AHF with kidney injury'],"['dopamine, nesiritide, or placebo', 'nAnnexin A1', 'Annexin A1']","['plasma AnxA1 levels', '60-day morbidity', 'Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels', 'risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality', 'experience creatinine elevation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.20289,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).","[{'ForeName': 'Fadi W', 'Initials': 'FW', 'LastName': 'Adel', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Rikhi', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Siu-Hin', 'Initials': 'SH', 'LastName': 'Wan', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Seethalakshmi R', 'Initials': 'SR', 'LastName': 'Iyer', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. Electronic address: Chen.Horng@mayo.edu.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.05.012']
1253,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
1254,32474062,The effects on ovarian activity of delaying versus immediately restarting combined oral contraception after missing three pills and taking ulipristal acetate 30 mg.,"OBJECTIVE


Among combined oral contraception (COC) users, to determine the effect on ovarian activity and ovulation of waiting five days before restarting COC, versus restarting immediately, having taken ulipristal acetate 30 mg (UPA, the dose used for emergency contraception) after missing three consecutive COC pills.
STUDY DESIGN


Women already using COC were enrolled for two cycles of COC use (21/7 regimen). In cycle 2, all women omitted COC pills for three consecutive days (days 5,6,7), and on day 8 took UPA 30 mg. They were randomized either to restart their COC pills that same day (immediate restart) or to wait five days (delayed restart). Transvaginal ultrasound, and blood sampling for estradiol and progesterone were undertaken on days 4,8,11,13,15,18,22 and 26. A modified Hoogland score was used to quantify ovarian activity/ovulation and to assess whether luteal phase progesterone concentrations were sufficiently 'adequate' to have conferred a theoretical risk of pregnancy.
RESULTS


No one ovulated with risk of pregnancy during the five days following UPA. Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle. Four of 23 women (17.4% CI [5.0; 38.8]) with delayed restart ovulated with theoretical risk of pregnancy before the end of the cycle. This difference was statistically significant (p = 0.042).
CONCLUSION


Women who delay restarting COC for five days after taking UPA 30 mg are at much greater risk of ovulation, and therefore theoretically of pregnancy, than if they restart their COC on the same day as taking UPA. Current recommendations should be revisited.
IMPLICATIONS


Women who take UPA-EC after having missed combined oral contraceptive pills are advised to wait five days before restarting the COC. This delay puts them at risk of ovulation and, if intercourse occurs, theoretically therefore of pregnancy. Women who restart their COC pills immediately are much less likely to ovulate. The label for UPA-EC and clinical guidelines on using EC after missed pills should be revisited.",2020,"Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle.","['Women who delay restarting COC for five after taking', 'Women already using COC were enrolled for two cycles of COC use (21/7 regimen', '26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle']","['UPA', 'combined oral contraception (COC']","['ovarian activity', 'Transvaginal ultrasound, and blood sampling for estradiol and progesterone', 'risk of ovulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4546343', 'cui_str': 'Uses contraception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0404588', 'cui_str': 'Finding related to risk factor in pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",26.0,0.105905,"Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle.","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Banh', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France. Electronic address: c.banh@HRA-PHARMA.COM.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Rautenberg', 'Affiliation': 'Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Duijkers', 'Affiliation': 'Dinox Consultancy, Marktstraat 19, 9712 PB Groningen, the Netherlands.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Borenzstein', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Monteil', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Levy-Gompel', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klipping', 'Affiliation': 'Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scherrer', 'Affiliation': 'Bruno Scherrer Conseil, 78730 Saint-Arnoult-en-Yvelines, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Midlothian EH16 4TJ, UK.""}]",Contraception,['10.1016/j.contraception.2020.05.013']
1255,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE


By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.
METHODS


This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.
CONCLUSION


This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047']
1256,32483939,Umbilical closure using 2-octyl cyanoacrylate in transumbilical laparoscopic adrenalectomy: A randomized controlled trial.,"OBJECTIVES


To evaluate postoperative pain and esthetic outcomes in patients undergoing transumbilical laparoscopic adrenalectomy with wound closure using 2-octyl cyanoacrylate.
METHODS


A total of 26 patients who underwent laparoscopic adrenalectomy with the transumbilical approach and agreed to participate in this study were included. Patients were randomly divided into two groups: the 2-octyl cyanoacrylate group (Glue group) or the non-use group (non-Glue group). A single surgeon (AM) carried out all procedures between 2014 and 2017.
RESULTS


There were no significant differences in the clinical background of the Glue and non-Glue groups. The number of patients with moderate or high levels of pain in the resting/moving period on postoperative days 1, 2 and 3 was 6/10 (46%/77%), 6/9 (46%/69%) and 3/5 (23%/38%) in the non-Glue group, and 5/7 (38%/54%), 2/7 (15%/54%) and 1/3 (8%/23%) in the Glue group. These differences were not significant. In the subgroup analysis of patients aged <50 years, the numbers were 4/6 (57%/86%), 5/7 (71%/100%) and 3/5 (43%/71%) in the non-Glue group, and 3/4 (33%/44%), 1/4 (11%/44%) and 0/1 (0%/11%) in the Glue group in the resting/moving period. On postoperative days 2 and 3, these differences were significant (P = 0.035 and 0.037 in the resting period, and P = 0.017 and 0.013 in the moving period).
CONCLUSIONS


2-octyl cyanoacrylate can be used safely for laparoscopic adrenalectomy with the transumbilical approach, and might be useful for reducing postoperative pain in patients aged <50 years.",2020,"On postoperative days 2 and 3, these differences were significant (P = 0.035 and 0.037 in the resting period, and P = 0.017 and 0.013 in the moving period).
","['26 patients who underwent', 'patients aged <50\xa0years', 'patients undergoing transumbilical', 'transumbilical laparoscopic adrenalectomy']","['2-octyl cyanoacrylate group (Glue group) or the non-use group (non-Glue group', 'laparoscopic adrenalectomy with the transumbilical approach', 'Umbilical closure using 2-octyl cyanoacrylate', 'laparoscopic adrenalectomy with wound closure using 2-octyl cyanoacrylate']","['postoperative pain and esthetic outcomes', 'number of patients with moderate or high levels of pain', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0457793', 'cui_str': 'Transumbilical'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}]","[{'cui': 'C0391770', 'cui_str': '2-octyl cyanoacrylate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}, {'cui': 'C0457793', 'cui_str': 'Transumbilical'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",26.0,0.050219,"On postoperative days 2 and 3, these differences were significant (P = 0.035 and 0.037 in the resting period, and P = 0.017 and 0.013 in the moving period).
","[{'ForeName': 'Keishiro', 'Initials': 'K', 'LastName': 'Fukumoto', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Miyajima', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Niwa', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hongo', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Kurihara', 'Affiliation': 'Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14270']
1257,32491236,The McGill Denture Satisfaction Questionnaire revisited: Exploratory factor analysis of a binational sample.,"OBJECTIVES


To examine the McGill Denture Satisfaction Questionnaire (MDSQ) in terms of dimensionality, item reduction and construct validity in a binational sample of complete denture wearers.
MATERIALS AND METHODS


We conducted secondary analyses of baseline data from two studies on implant-retained overdentures: a quasi-experimental study in the United States (n = 145) and a randomised trial in Brazil (n = 120). All participants wore upper/lower dentures and responded at baseline to the MDSQ items concerning their original mandibular dentures. A putative model of the MDSQ items resulted in two question subsets: (a) overall satisfaction, retention/stability, aesthetics, cleaning, speech and comfort, plus general chewing ability; (b) mastication of specific foods. Analyses focused on the internal consistency of each subset and possible item reduction, using Cronbach's alpha (Cα), inter-item correlation and exploratory factor analysis (EFA).
RESULTS


The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8). An item on cleaning had low correlation, but its removal does not increase internal consistency (Cα ≥ .83). Results were similar for both studies, with EFA showing a single significant factor (namely ""overall satisfaction, lower denture"") able to explain nearly 54% of the variance. The 2nd subset also shows strong internal consistency (Cα ≥ .95) and inter-item correlation, with a single factor representing 65% of the variation.
CONCLUSIONS


This study discloses the reliability and construct validity of the MDSQ for patient-centred evaluation of complete dental prostheses in the edentulous mandible. Findings also support the use of both ""overall satisfaction"" and ""masticatory ability"" as summary scores, for improved outcome assessment.",2020,The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8).,"['patient-centred evaluation of complete dental prostheses in the edentulous mandible', 'We conducted secondary analyses of baseline data from two studies on implant-retained overdentures: a quasi-experimental study in the United States (n\xa0=\xa0145) and a randomised trial in Brazil (n\xa0=\xa0120', 'binational sample of complete denture wearers']",['MDSQ'],"['overall satisfaction, retention/stability, aesthetics, cleaning, speech and comfort, plus general chewing ability; (b) mastication of specific foods', 'internal consistency ', ""Cronbach's alpha (Cα), inter-item correlation and exploratory factor analysis (EFA"", 'McGill Denture Satisfaction Questionnaire (MDSQ', 'single significant factor (namely ""overall satisfaction, lower denture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",145.0,0.0931388,The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8).,"[{'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Ribeiro', 'Affiliation': 'School of Dentistry, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Oates', 'Affiliation': 'School of Dentistry, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Jocelyne S', 'Initials': 'JS', 'LastName': 'Feine', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, Montreal, QC, Canada.'}]",Gerodontology,['10.1111/ger.12477']
1258,32485095,"Differential effects of testosterone on circulating neutrophils, monocytes, and platelets in men: Findings from two trials.","BACKGROUND


Testosterone treatment increases erythrocytes in men, but its effects on leukocyte and platelet counts are unknown and could affect its safety.
OBJECTIVE


To determine whether testosterone affects circulating leukocytes and platelets in men.
METHODS


Secondary analyses of two randomized testosterone trials were performed: the 5α-reductase (5aR) and OPTIMEN trials. In 5aR trial, 102 healthy men, 21-50 years (mean age 38), received a long-acting GnRH agonist, and 50, 125, 300, or 600 mg/week testosterone enanthate (TE) plus placebo or 2.5 mg /  day dutasteride for 20 weeks. In OPTIMEN, 78 functionally limited men, ≥65 years (mean age 72) with protein intake ≤ 0.83 g kg -1   day -1  , were randomized to controlled diets with 0.8 g kg -1   day -1  protein or 1.3 g kg -1   day -1  protein plus placebo or TE (100 mg/week) for 6 months. Changes from baseline in total and differential leukocyte count, and platelet count were evaluated.
RESULTS


In 5aR, testosterone administration was associated with increases in total leukocyte (estimated change from baseline 40, 490, 1230, and 1280 cells/µL, P < .001), neutrophil (65.1, 436.1, 1177.2, and 1192.2 cells/µL, P < .001), monocyte (-20.2, 24.5, 90.6, and 143.9 cells/µL, P < .001), platelet (-7.3, 8.4, 8.7, and 8.9 × 10 3  cells/µL, P = .033), and erythrocyte counts. Testosterone did not affect absolute lymphocyte count. Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77 × 10 3  cells/µL, P vs placebo = 0.004).
CONCLUSIONS


Testosterone administration in men differentially increases neutrophil and monocyte counts. These findings, together with its erythropoietic effects, suggest that testosterone promotes the differentiation of hematopoietic progenitors into the myeloid lineage. These findings have potential mechanistic, therapeutic, and safety implications.",2020,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"['78 functionally-limited men, ≥65 years (mean age 72) with protein intake ≤0.83 g *  kg -1   *  day -1', 'men', '102 healthy men, 21-50 years (mean age 38', 'Men']","['controlled diets with 0.8 g *  kg -1   *  day -1  protein or 1.3 g *  kg -1   *  day -1  protein plus placebo or TE', 'testosterone', 'Testosterone', 'enanthate (TE) plus placebo', '5α-Reductase (5aR']","['total and differential leukocyte count, and platelet count', 'monocyte', 'total leukocyte', 'total leukocyte count', 'Peripheral Neutrophils, Monocytes and Platelets', 'platelet', 'neutrophil and monocyte counts', 'absolute lymphocyte count', 'neutrophil', 'erythrocyte counts']","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0019226', 'cui_str': 'Enanthates'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162401', 'cui_str': 'Differential white blood cell count procedure'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",102.0,0.505029,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Gagliano-Jucá', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Andrology,['10.1111/andr.12834']
1259,32585354,The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.,"BACKGROUND


Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies.
OBJECTIVE


To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received.
METHODS


Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT.
RESULTS


Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT.
CONCLUSIONS


In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016']
1260,32584828,Potentials and pitfalls of increasing prosocial behavior and self-efficacy over time using an online personalized platform.,"BACKGROUND


This longitudinal mixed methods experimental study aimed to better understand the interplay between digital technology exposure over time, self-efficacy, and prosocial behavior in everyday contexts.
METHODS


66 psychology students tracked their daily prosocial behavior over three weeks. Additionally, half of the participants were randomly assigned to receive access to an online platform, which made personalized suggestions for prosocial actions to complete. Qualitative post-study interviews complemented quantitative measures.
RESULTS


Platform exposure had no measurable impact beyond that of tracking over time on either prosocial behavior or self-efficacy. Tracking increased self-efficacy to perform everyday prosocial actions, but did not affect self-efficacy to impact change. Prosocial behavior was predicted by self-efficacy to impact change. Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future. Avenues for increasing platform effectiveness include context-specific action personalization, an effective reminder system, and better support for the development of self-efficacy to impact change through meaningful actions.
CONCLUSION


Technology for prosocial behavior should be enjoyable, capable of being seamlessly integrated into everyday life, and ensure that suggested actions are perceived as meaningful in order to support the sustainable development of self-efficacy and prosocial behavior over time.",2020,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,['66 psychology students tracked their'],[],"['prosocial behavior and self-efficacy', 'daily prosocial behavior', 'prosocial behavior or self-efficacy', 'self-efficacy', 'Prosocial behavior']","[{'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0040594', 'cui_str': 'Track'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",66.0,0.025428,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,"[{'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Steinemann', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Geelan', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zaehringer', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Kamalatharsi', 'Initials': 'K', 'LastName': 'Mutuura', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Ewgenij', 'Initials': 'E', 'LastName': 'Wolkow', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frasseck', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Opwis', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}]",PloS one,['10.1371/journal.pone.0234422']
1261,32584834,Gender-differences in predictors for time to metabolic syndrome resolution: A secondary analysis of a randomized controlled trial study.,"Understanding gender differences in health-related behaviors and their impacts is a crucial aspect of effective primary care. We studied gender-based differences in predictors of metabolic syndrome (MetS) resolution among newly diagnosed MetS patients. This study was a secondary analysis of a prospective clinical trial study comprising of 637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces. We conducted Cox proportional hazard analysis to estimate cumulative probability of MetS resolution within a 12-month observation period. Among the 637 patients, 47.6% of participants achieved MetS resolution. The resolution rate was similar among men and women (44.7% and 49.1%, respectively, P = 0.320). Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women. For women, however, longer sleeping hours (1.18, 1.04-1.34) and living with a partner (1.58, 1.06-2.35) were positive predictors of MetS resolution. Being overweight (0.63, 0.44-0.89) was associated with lower cumulative probability of MetS resolution in women than in men. The factors associated with cumulative probability of MetS resolution within the 12-month follow-up were different between men and women. These findings facilitate further exploration on gender-based differences in risk factors for less optimal improvements in MetS.",2020,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","['637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces', 'newly diagnosed MetS patients']",[],"['metabolic syndrome (MetS) resolution', 'current employment', 'cumulative probability of MetS resolution', 'MetS resolution', 'resolution rate']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",637.0,0.231571,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","[{'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Choe', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, CHA University, Gyunggi-do, Republic of Korea.'}, {'ForeName': 'Nan-He', 'Initials': 'NH', 'LastName': 'Yoon', 'Affiliation': 'Department of Health Administration, Hanyang Cyber University, Seoul, Republic of Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyekyeong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Health Convergence, Ewha Womans University, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0234035']
1262,32589648,"Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study).","Despite the availability of effective antimicrobials, tuberculosis (TB) is still a serious health threat. Mortality is even higher in people living with HIV who are diagnosed with TB. New therapies are needed to shorten the time required to cure TB and decrease fatality rates in this population. N-acetylcysteine (NAC) is a glutathione precursor and has shown recently in experimental setting to present in vitro and in vivo anti-mycobacterial activity. We test the hypothesis that NAC is safe, well tolerated and secondarily efficacious as adjunctive anti-TB therapy in hospitalized individuals with HIV-associated TB. Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon. We performed a randomized, parallel group, single-center, open study trial of two arms, in hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC Group). A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively. Adverse event rates were similar in the two arms. Our findings suggest that in the more critical population of hospitalized patients with HIV-associated TB, the use of NAC was not unsafe, despite the low sample size, and a potential impact on faster negative cultures needs to be further explored in larger studies.",2020,Adverse event rates were similar in the two arms.,"['hospitalized individuals with HIV-associated TB', 'hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with', 'Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon', 'A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively', 'people living with HIV who are diagnosed with TB', 'hospitalized patients with HIV-associated tuberculosis']","['NAC', 'N-acetylcysteine (NAC', 'N-acetylcysteine', 'rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC']","['Adverse event rates', 'Safety and efficacy', 'Mortality']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",21.0,0.095281,Adverse event rates were similar in the two arms.,"[{'ForeName': 'Izabella Picinin', 'Initials': 'IP', 'LastName': 'Safe', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vitoria Silva', 'Initials': 'VS', 'LastName': 'Printes', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Adriana Ferreira', 'Initials': 'AF', 'LastName': 'Praia Marins', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Amanda Lia', 'Initials': 'AL', 'LastName': 'Rebelo Rabelo', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Amanda Araújo', 'Initials': 'AA', 'LastName': 'Costa', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Michel Araújo', 'Initials': 'MA', 'LastName': 'Tavares', 'Affiliation': 'Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Jaquelane Silva', 'Initials': 'JS', 'LastName': 'Jesus', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Alexandra Brito', 'Initials': 'AB', 'LastName': 'Souza', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Beraldi-Magalhães', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Cynthia Pessoa', 'Initials': 'CP', 'LastName': 'Neves', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Eduardo P', 'Initials': 'EP', 'LastName': 'Amaral', 'Affiliation': 'Immunobiology Section, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Renata Spener', 'Initials': 'RS', 'LastName': 'Gomes', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Bruno B', 'Initials': 'BB', 'LastName': 'Andrade', 'Affiliation': 'Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz (FIOCRUZ), Salvador, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cordeiro-Santos', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}]",PloS one,['10.1371/journal.pone.0235381']
1263,32589670,"Does the type of foam roller influence the recovery rate, thermal response and DOMS prevention?","PURPOSE


Supporting post-exercise recovery requires choosing not only the right treatment but also the equipment, in which the impact is not always clear. The study aimed to determine the effect of foam rolling on the rate of lactate removal and DOMS prevention and whether the type of foam roller is effective in the context of post-exercise recovery.
METHODS


This randomized trial enrolled 33 active healthy males divided into three groups of eleven individuals: foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS). All the participants performed full squat jumps for one minute. Examination took place at rest (thermal imaging of skin temperature-[Tsk] and blood lactate-[LA]), immediately following exercise (Tsk & LA), immediately after recovery treatment (Tsk) and after 30 minutes of rest (Tsk & LA). Their pain levels were assessed using the Visual Analog Scale (VAS) 24, 48, 72, and 96 hours after exercise.
RESULTS


The magnitude of lactate decrease depended on the type of recovery used. In the PAS group, the decrease in lactate concentration by 2.65 mmol/L following a half-hour rest was significantly lower than that in the other groups (STH vs. PAS p = 0.042 / GRID vs. PAS p = 0.025). For thermal responses, significant differences between both experimental groups were noted only 30 minutes after exercise. A significant decrease in pain in the STH group occurred between 48 and 96 hours, while the GRID group showed a systematic significant decrease in VAS values in subsequent measurements. Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05).
CONCLUSIONS


Foam rolling seems to be effective for enhancing lactate clearance and counteracting DOMS, but the type of foam roller does not seem to influence the recovery rate.",2020,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05).
",['33 active healthy males divided into three groups of eleven individuals'],['foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS'],"['VAS values', 'lactate concentration', 'pain levels', 'recovery rate, thermal response and DOMS prevention', 'pain']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",33.0,0.0430707,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05).
","[{'ForeName': 'Jakub Grzegorz', 'Initials': 'JG', 'LastName': 'Adamczyk', 'Affiliation': 'Theory of Sport Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Gryko', 'Affiliation': 'Athletics and Team Sport Games Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Boguszewski', 'Affiliation': 'Rehabilitation Department, Physiotherapy Division, Medical University of Warsaw, Warsaw, Poland.'}]",PloS one,['10.1371/journal.pone.0235195']
1264,32456618,"Effectiveness of mobile SMS based counselling intervention in improving the knowledge, attitude, and practices of HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia: a mixed mode study protocol.","BACKGROUND


HIV/AIDS is one of the most serious problems in many parts of the world, and is a high priority for health managers and decision-makers. The aim of the qualitative part of this study will be to develop a mobile SMS (short messaging services) counselling intervention to prevent HIV/AIDS, while the quantitative part will be to test the effectiveness of a mobile SMS counselling intervention to improve the knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS.
METHOD


A mixed methods approach will be used. Qualitative part: Design: focus group discussions (FGDs) will be conducted.
SETTING


Hospital/NGOs in Terengganu, Malaysia.
PARTICIPANTS


Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders. One FGD will be conducted for each group. Three in-depth interviews (IDIs) will be conducted with patients who had HIV/AIDS, of which one will be female. Quantitative part: Design: a cluster randomized clinical trial with 384 HIV/AIDS patients in Terengganu, Malaysia.
INTERVENTION


Mobile SMS counselling intervention for patients concerning the prevention of HIV/AIDS.
RESULTS


The main outcomes of this study will be the differences in knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS between the baseline and immediate follow-up after the intervention, and after 3 months.
CONCLUSIONS


The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
TRIAL REGISTRATION


Thai Clinical Trials Registry, TCTR20200212001; 7/02/2020.",2020,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
","['Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders', '384 HIV/AIDS patients in Terengganu, Malaysia', 'Hospital/NGOs in Terengganu, Malaysia', 'HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia', 'patients who had HIV/AIDS, of which one will be female']","['mobile based SMS counselling intervention', 'mobile SMS based counselling intervention', 'Mobile SMS counselling intervention', 'mobile SMS counselling intervention']","['knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS']","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]",384.0,0.220058,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
","[{'ForeName': 'Md Mosharaf', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia. md.hossain@umt.edu.my.'}, {'ForeName': 'Ruhani Binti Mat', 'Initials': 'RBM', 'LastName': 'Min', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Zikri', 'Initials': 'Z', 'LastName': 'Muhammad', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Kulanthayan K C', 'Initials': 'KKC', 'LastName': 'Mani', 'Affiliation': 'Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}]",BMC public health,['10.1186/s12889-020-08910-3']
1265,32463140,Efficacy and safety of three times daily dosing of tacrolimus in pediatric kidney transplantation patients: A single-center comparative study.,"BACKGROUND/AIM


Several PK studies have shown that most pediatric patients may require higher doses on a mg/kg basis compared to adults to attain similar therapeutic trough concentrations. The aim of this study was to compare the efficacy and safety of three times daily to twice a day dosing of tacrolimus in pediatric kidney transplant recipients at a major tertiary care transplant center.
METHODS AND MATERIALS


Retrospective, single-center, and comparative cohort study. All pediatric kidney transplant recipients received either tacrolimus BID (group 1) or tacrolimus TID (group 2).
RESULTS


A total of 87 patients were included in this study; 48 patients received BID tacrolimus (group 1), and 39 patients received TID tacrolimus (group 2). The percentage of patients who achieved therapeutic trough concentrations in group 2 did not significantly differ from those in group 1 at day 7 (84.62% TID vs 83.33% BID; P = .42). The median time to reach therapeutic trough concentrations was three days in group 1 compared to four days in group 2.
CONCLUSION


No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.",2020,No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.,"['87 patients were included in this study; 48 patients received', 'pediatric kidney transplantation patients', 'pediatric kidney transplant recipients at a major tertiary care transplant center', 'All pediatric kidney transplant recipients']","['tacrolimus TID', 'tacrolimus BID', 'BID tacrolimus', 'TID tacrolimus', 'tacrolimus']","['efficacy and safety', 'percentage of patients who achieved therapeutic trough concentrations', 'Efficacy and safety', 'median time to reach therapeutic trough concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",87.0,0.0266428,No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.,"[{'ForeName': 'Zinah', 'Initials': 'Z', 'LastName': 'Alabdulkarim', 'Affiliation': 'Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al-Jedai', 'Affiliation': 'Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Delal', 'Initials': 'D', 'LastName': 'Alkortas', 'Affiliation': 'Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Alhasan', 'Affiliation': 'Kidney & Pancreas Transplantation Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Devol', 'Affiliation': 'Biostatistics Epidemiology & Scientific Computing Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}]",Pediatric transplantation,['10.1111/petr.13733']
1266,32460804,Views among Malawian women about joining HIV prevention clinical trials when pregnant.,"BACKGROUND


The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women's views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population.
METHODS


We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women's perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach.
RESULTS


A majority of women accepted participation in all trials. Women's views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions.
CONCLUSIONS


The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.",2020,"Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low.","['35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa', 'Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy']",['oral PrEP (Truvada) (2) a vaginal ring (dapivirine'],[],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0574464', 'cui_str': 'Nyanja language'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}]",[],3.0,0.0678425,"Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA. ksullivan@med.unc.edu.'}, {'ForeName': 'Tiwonge', 'Initials': 'T', 'LastName': 'Mtande', 'Affiliation': 'UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Jaffe', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Health Behavior, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 170 Rosenau Hall, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Chifundo', 'Initials': 'C', 'LastName': 'Zimba', 'Affiliation': 'UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Bioinformatics Building, 130 Mason Farm Road, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'The Kennedy Institute of Ethics, Georgetown University, 3700 O Street Northwest, Washington, DC, 20057, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Faden', 'Affiliation': 'Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Anne Drapkin', 'Initials': 'AD', 'LastName': 'Lyerly', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00271-6']
1267,32461104,Tumor mutational burden and immune infiltration as independent predictors of response to neoadjuvant immune checkpoint inhibition in early TNBC in GeparNuevo.,"BACKGROUND


The predictive value of tumor mutational burden (TMB), alone or in combination with an immune gene expression profile (GEP), for response to neoadjuvant therapy in early triple negative breast cancer (TNBC) is currently not known, either for immune checkpoint blockade (ICB) or conventional chemotherapy.
PATIENTS AND METHODS


We obtained both whole exome sequencing and RNA-Seq data from pretreatment samples of 149 TNBC of the recent neoadjuvant ICB trial, GeparNuevo. In a predefined analysis, we assessed the predictive value of TMB and a previously developed immune GEP for pathological complete remission (pCR).
RESULTS


Median TMB was 1.52 mut/Mb (range 0.02-7.65) and was significantly higher in patients with pCR (median 1.87 versus 1.39; P = 0.005). In multivariate analysis, odds ratios for pCR per mut/Mb were 2.06 [95% confidence intervals (CI) 1.33-3.20, P = 0.001] among all patients, 1.77 (95% CI 1.00-3.13, P = 0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P = 0.016) in the placebo treatment arm, respectively. We also found that both continuous TMB and immune GEP (or tumor infiltrating lymphocytes) independently predicted pCR. When we stratified patients in groups based on the upper tertile of TMB and median GEP, we observed a pCR rate of 82% (95% CI 60% to 95%) in the group with both high TMB and GEP in contrast to only 28% (95% CI 16% to 43%) in the group with both low TMB and GEP.
CONCLUSIONS


TMB and immune GEP add independent value for pCR prediction. Our results recommend further analysis of TMB in combination with immune parameters to individually tailor therapies in breast cancer.",2020,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.",['early triple negative breast cancer (TNBC'],[],"['pCR rate', 'Median TMB']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]",[],"[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",,0.160939,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University, Frankfurt, Germany. Electronic address: t.karn@em.uni-frankfurt.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Weber', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Holtrich', 'Affiliation': 'Goethe University, Frankfurt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jank', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Sinn', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University Hospital, Ulm, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'University Hospital, Kiel, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'University Hospital, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum, Hamburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'University Hospital, Aachen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Comprehensive Cancer Center, Friedrich-Alexander University, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center of Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.015']
1268,32464224,Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial.,"OBJECTIVE


To determine whether higher-volume feedings improve postnatal growth among infants born very preterm.
STUDY DESIGN


Randomized clinical trial with 1:1 parallel allocation conducted from January 2015 to June 2018 in a single academic medical center in the US. In total, 224 infants with a birth weight 1001-2500 g born at <32 weeks of gestation were randomized to higher-volume (180-200 mL/kg/d) or usual-volume (140-160 mL/kg/d) feedings after establishing full enteral feedings (≥120 mL/kg/d). The primary outcome was growth velocity (g/kg/d) from randomization to study completion at 36 weeks of postmenstrual age or hospital discharge if earlier.
RESULTS


Growth velocity increased among infants in the higher-volume group compared with the usual-volume group (mean [SD], 20.5 [4.5] vs 17.9 [4.5] g/kg/d; P < .001). At study completion, all measurements were higher among infants in the higher-volume group compared with the usual-volume group: weight (2365 [324] g, z score -0.60 [0.73] vs 2200 [308] g, z score -0.94 [0.71]; P < .001); head circumference (31.9 [1.3] cm, z score -0.30 [0.91] vs 31.4 [1.3] cm, z score -0.53 [0.84]; P = .01); length (44.9 [2.1] cm, z score -0.68 [0.88] vs 44.4 [2.0], z score -0.83 [0.84]; P = .04); and mid-arm circumference (8.8 [0.8] cm vs 8.4 [0.8] cm; P = .002). Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
CONCLUSIONS


In infants born very preterm weighing 1001-2500 g at birth, higher-volume feedings increased growth velocity, weight, head circumference, length, and mid-arm circumference compared with usual-volume feedings without adverse effects.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT02377050.",2020,"Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
","['Very Preterm Infants', '224 infants with a birth weight 1001-2500 grams born at <32 weeks of gestation', 'very preterm infants', '1/2015 to 6/2018 in a single academic medical center in the United States']",['usual volume feedings'],"['growth velocity, weight, head circumference, length, and mid-arm circumference', 'Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis', 'growth velocity', 'head circumference', 'hospital discharge if earlier', 'Growth velocity']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",224.0,0.372561,"Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
","[{'ForeName': 'Colm P', 'Initials': 'CP', 'LastName': 'Travers', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL. Electronic address: ctravers@peds.uab.edu.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Pediatrics, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Pediatrics, Division of Neonatology, University of Maryland, Baltimore, MD.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Dills', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Surgery, Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Laney', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Pediatrics, Division of Neonatology, Nemours Alfred I. duPont Hospital for Children, Wilmington, DE.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Winter', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.05.033']
1269,32487180,Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families: study protocol for a quasi-experimental trial.,"BACKGROUND


Need-oriented family support programs are examples of voluntary-based interventions increasingly recognized by the public sector as an important contribution to health and social care provision. Voluntary interventions are attractive because of their focus on activism, inclusion, and participation, but also their low cost and easy accessibility. There is an increasing demand for documentation of the effectiveness of family support programs. Methodologically sound studies are, however, limited and findings are generally inconsistent. This trial aims to assess the effectiveness of the volunteer-based intervention Family Club Denmark on parental stress, mental health, development and well-being of parents and children and to get insight into the experiences of both volunteers and families.
METHODS


This is a prospective quasi-experimental trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group. Participants are families with children aged 2-12 years who wish to participate in the program. Participants are allocated to intervention primarily after a first-come-first-serve principle, and further families will join the wait-list and be offered participation after around 6 months. Quantitative data are collected through web surveys at three time-points: at baseline, post-intervention (6 months after baseline), and follow-up (12 months after baseline). The primary outcome is mental health. Secondary outcomes include parenting behavior, parenting stress, self-efficacy and self-worth, family routines and child well-being. Qualitative data are collected through observations, focus groups, and interviews.
DISCUSSION


This trial is among the first experimental studies of a group-based third sector need-oriented family support program offered to a wide array of families. The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines. Furthermore, the trial will provide knowledge on volunteer, parent, and child experiences with participating in the intervention and knowledge on how to conduct experimental trails in a complex volunteer environment.
TRIAL REGISTRATION


ClinicalTrials.govNCT03657888 (registered 29.08.2018).",2020,"The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines.","['Participants are families with children aged 2-12\u2009years who wish to participate in the program', 'Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families']","['intervention group participating in Family Club Denmark and (2) wait-list control group', 'volunteer-based intervention Family Club Denmark']","['mental health', 'parenting behavior, parenting stress, self-efficacy and self-worth, family routines and child well-being']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}]",,0.0487298,"The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines.","[{'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Pontoppidan', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark. mpo@vive.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thorsager', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}, {'ForeName': 'Arendse Tange', 'Initials': 'AT', 'LastName': 'Larsen', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Friis-Hansen', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}]",BMC psychology,['10.1186/s40359-020-00426-0']
1270,32581121,Toward a science of delivering aid with dignity: Experimental evidence and local forecasts from Kenya.,"How can governments and nonprofits design aid programs that afford dignity and facilitate beneficial outcomes for recipients? We conceptualize dignity as a state that manifests when the stigma associated with receiving aid is countered and recipients are empowered, both in culturally resonant ways. Yet materials from the largest cash transfer programs in Africa predominantly characterize recipients as needy and vulnerable. Three studies examined the causal effects of alternative aid narratives on cash transfer recipients and donors. In study 1, residents of low-income settlements in Nairobi, Kenya ( N =  565) received cash-based aid accompanied by a randomly assigned narrative: the default deficit-focused ""Poverty Alleviation"" narrative, an ""Individual Empowerment"" narrative, or a ""Community Empowerment"" narrative. They then chose whether to spend time building business skills or watching leisure videos. Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma. Given the diverse settings in which aid is delivered, how can organizations quickly identify effective narratives in a context? We asked recipients to predict which narrative would best motivate skill-building in their community. In study 2, this ""local forecasting"" methodology outperformed participant evaluations and experimental pilots in accurately ranking treatments. Finally, study 3 confirmed that the narrative most effective for recipients did not undermine donors' willingness to contribute to the program. Together these studies show that responding to recipients' psychological and sociocultural realities in the design of aid can afford recipients dignity and help realize aid's potential.",2020,"Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma.","['residents of low-income settlements in Nairobi, Kenya ( N =  565) received']","['dignity', 'cash-based aid accompanied by a randomly assigned narrative: the default deficit-focused ""Poverty Alleviation"" narrative, an ""Individual Empowerment"" narrative, or a ""Community Empowerment"" narrative']",['self-efficacy and anticipated social mobility'],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0181758,"Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma.","[{'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305; ccthomas@stanford.edu hmarkus@stanford.edu.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Otis', 'Affiliation': 'Division of Health Policy and Management, University of California, Berkeley, CA 94720.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Abraham', 'Affiliation': 'Department of Economics, University of California, San Diego, CA 92161.'}, {'ForeName': 'Hazel Rose', 'Initials': 'HR', 'LastName': 'Markus', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305; ccthomas@stanford.edu hmarkus@stanford.edu.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Walton', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1917046117']
1271,32583907,Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation.,"BACKGROUND


Agonists of 5-hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS-C). However, only tegaserod has been approved for a very limited population in the US.
AIM


To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS-C.
METHODS


A double-blind, placebo-controlled, dose-finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The primary endpoint was Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements from baseline and improvement of ≥30% from baseline in weekly average of worst abdominal pain score, both in the same week for ≥6/12 weeks).
RESULTS


The FDA composite responder rate was 13.6% (14/103) in the placebo group, 13.6% (14/103) in the 10 mg group, 19.2% (20/104) in the 20 mg group and 14.9% (15/101) in the 40 mg group, and no dose-response relationship was found. A greater percentage of minesapride 40 mg-treated patients than placebo-treated patients met both responder requirements for ≥9/12 weeks as the stricter composite evaluation (P < 0.05). Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12). The most common adverse event was mild diarrhoea.
CONCLUSIONS


Minesapride was safe and well-tolerated. Although the primary endpoint was negative, minesapride 40 mg is likely to improve the stricter composite endpoint and SBM frequency. Japan Pharmaceutical Information Center Number: Japic CTI-163459.",2020,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","['irritable bowel syndrome with predominant constipation (IBS-C', 'patients with Rome IV defined IBS-C', 'irritable bowel syndrome with predominant constipation', '411 patients']","['5-hydroxytryptamine', 'minesapride vs placebo', 'minesapride', 'placebo']","['stricter composite endpoint and SBM frequency', 'SBM frequency', 'Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements', 'efficacy and safety', 'safe and well-tolerated', 'worst abdominal pain score', 'FDA composite responder rate']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",411.0,0.467554,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","[{'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Inada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kiyoyasu', 'Initials': 'K', 'LastName': 'Kazumori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15907']
1272,32589302,Effects of chewing exercises on the occlusal force and masseter muscle thickness in community-dwelling Koreans aged 65 years and older: A randomised assessor-blind trial.,"Chewing exercises have been applied in clinical settings to improve the occlusal force and function of the masseter muscle in elderly individuals. However, the clinical relevance and effects of chewing exercises are unclear. This study aimed to investigate the effects of bilateral chewing exercises on the occlusal force and masseter muscle thickness in community-dwelling Koreans aged 65 years. Forty community-dwelling healthy elderly individuals were enrolled in this study. They were assigned to the experimental or the control group. The experimental group performed chewing exercises using medical equipment developed to facilitate such exercises. The chewing exercises were divided into isometric and isotonic types and were performed for 20 min/d, 5 days/wk, for 6 weeks. The control group did not perform any chewing exercises. The outcome measures were occlusal force and masseter muscle thickness, which were evaluated using an occlusometer and ultrasound device, respectively. A paired t test and an independent t test were used to evaluate the training effects. Within-group comparisons showed that occlusal force and masseter muscle thickness improved significantly in the experimental group (P < .001 for both), while the control group showed no significant improvements (P = .098 and .130). Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (P < .05 for both) compared to the control group. These results suggest that chewing exercises are effective in improving occlusal force and masseter muscle thickness in healthy elderly individuals.",2020,"Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (p < 0.05 for both) compared to the control group.
","['elderly individuals', 'community-dwelling Koreans aged 65 years and older', 'community-dwelling Koreans aged 65 years', 'Forty community-dwelling healthy elderly individuals', 'healthy elderly individuals']","['chewing exercises using medical equipment developed to facilitate such exercises', 'chewing exercises', 'bilateral chewing exercises', 'control group did not perform any chewing exercises']",['occlusal force and masseter muscle thickness'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0589278', 'cui_str': 'Chewing exercises'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0261273,"Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (p < 0.05 for both) compared to the control group.
","[{'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Hygiene, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Multidisplinary Radiological Science, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Samsung Medical Center, Heart Vascular Stroke Institute, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Occupational Therapy, Division of Health Sciences, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Se-Hyun', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Dental Hygiene, DongJu College, Busan, South Korea.'}, {'ForeName': 'Hwan-Hee', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon, South Korea.'}, {'ForeName': 'YoungJin', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Department of Multidisplinary Radiological Science, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, South Korea.'}]",Journal of oral rehabilitation,['10.1111/joor.13036']
1273,32590148,Physical and mental health effects of repeated short walks in a blue space environment: A randomised crossover study.,"INTRODUCTION


Blue spaces may benefit mental health and promote physical activity, although the evidence is still scarce. And benefits on physical health are less consistent. The objective of this randomized crossover study was to assess psychological and cardiovascular responses to blue spaces' exposure.
METHODS


A sample of 59 healthy adult office workers was randomly assigned to a different environment (i.e. blue space, urban space, and control site) on 4 days each week, for 3 weeks. For 20 min per day, they either walked along a blue or an urban space or rested at a control site. Before, during and/or after the exposure, we measured self-reported well-being and mood, blood pressure, and heart rate variability parameters. For well-being, we also assessed the duration of these potential effects over time (at least 4 h after exposure).
RESULTS


We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site. Cardiovascular responses showed increased activity of the sympathetic nervous system, both during and after walking along the blue and urban spaces. However, cardiovascular responses measured after the walks, showed no statistically significant differences between the blue and the urban space environments.
CONCLUSIONS


Short walks in blue spaces can benefit both well-being and mood. However, we did not observe a positive effect of blue spaces for any of the cardiovascular outcomes assessed in this study.",2020,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,['59 healthy adult office workers'],[],"['psychological and cardiovascular responses', 'cardiovascular responses', 'self-reported well-being and mood, blood pressure, and heart rate variability parameters', 'well-being and mood responses', 'Physical and mental health effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",59.0,0.0763709,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vert', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Gascon', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Ranzani', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Márquez', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Triguero-Mas', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain; Institute for Environmental Science and Technology, Barcelona, Spain; IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Barcelona Lab for Urban Environmental Justice and Sustainability, Barcelona, Spain.'}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Carrasco-Turigas', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Arjona', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Llopis', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Donaire-Gonzalez', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Institute for Risk Assessment Sciences (IRAS), Division of Environmental Epidemiology (EEPI), Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Lewis R', 'Initials': 'LR', 'LastName': 'Elliott', 'Affiliation': 'European Centre for Environment and Human Health, University of Exeter Medical School, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nieuwenhuijsen', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: mark.nieuwenhuijsen@isglobal.org.'}]",Environmental research,['10.1016/j.envres.2020.109812']
1274,32591475,"Natalizumab in acute ischemic stroke (ACTION II): A randomized, placebo-controlled trial.","OBJECTIVE


We evaluated the effect of 2 doses of natalizumab on functional outcomes in patients with acute ischemic stroke (AIS).
METHODS


In this double-blind phase 2b trial, patients with AIS aged 18-80 years with NIH Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg IV natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model;  p  values were not used for hypothesis testing.
RESULTS


An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90.0%, 92.1%, and 92.3%, respectively), serious adverse events (25.6%, 32.6%, and 20.9%, respectively), or deaths (6.7%, 4.5%, and 5.5%, respectively).
CONCLUSIONS


Natalizumab administered ≤24 hours after AIS did not improve patient outcomes.
CLINICALTRIALSGOV IDENTIFIER


NCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.",2020,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"['patients with AIS', 'acute ischemic stroke (AIS) patients', 'AIS patients aged 18-80 years with National Institutes of Health Stroke Scale scores of 5-23 from 53 US and European sites']","['Natalizumab', 'placebo (natalizumab', 'natalizumab or placebo, with randomization stratified by treatment window ', 'natalizumab', 'placebo']","['serious adverse events', 'deaths', 'patient outcomes', 'composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.783971,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"[{'ForeName': 'Mitchell S V', 'Initials': 'MSV', 'LastName': 'Elkind', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA. mse13@columbia.edu.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Montaner', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Aneesh B', 'Initials': 'AB', 'LastName': 'Singhal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Kasliwal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Elkins', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}]",Neurology,['10.1212/WNL.0000000000010038']
1275,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE


To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM).
METHODS


A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated.
RESULTS


Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
CONCLUSIONS


The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024']
1276,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE


To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK).
METHOD


The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting.
RESULTS


The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed.
CONCLUSION


Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005']
1277,32460989,"Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study.","BACKGROUND


Sodium hyaluronate has been proposed as a treatment for improving the symptoms of chronic rhinosinusitis. The present study evaluated the effect of the intranasal administration of hyaluronic acid in a group of patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP).
MATERIALS AND METHODS


Thirty subjects aged 18-65 years affected by CRSsNP were enrolled. The subjects were randomly administered hyaluronic acid or isotonic saline solution by nasal nebulizer twice per day for 30 days. They were evaluated before (T0) and after the treatment (T1) with Sino-Nasal Outcome Test-22, visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology.
RESULTS


Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters. Being included in the study group rather than in the control group did not have a significant effect on the variation of the considered parameters between T0 and T1. Considering the effects of the micronized douches independently from the type of solution used (either hyaluronic acid or isotonic saline solution), although no difference emerged between study and control group for any of the objective parameters, there was an improvement of Sino-Nasal Outcome Test-22 scores (p = .0005), visual analogue scale for nasal obstruction (p = .0006) and for hyposmia/hypogeusia (p = .04).
CONCLUSIONS


The treatment with micronized nasal douches can improve the sino-nasal symptoms of CRSsNP, in particular nasal obstruction and olfactory ability. No advantage of the use of hyaluronic acid over isotonic saline solution emerged.",2020,"Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters.","['Thirty subjects aged 18-65\xa0years affected by CRSsNP were enrolled', 'non-polipoid chronic rhinosinusitis', 'patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP']","['micronized nasal irrigations with hyaluronic acid/isotonic saline solution', 'hyaluronic acid', 'hyaluronic acid or isotonic saline solution']","['Sino-Nasal Outcome Test-22 scores', 'visual analogue scale for nasal obstruction', 'objective and subjective parameters', 'sino-nasal symptoms of CRSsNP', 'visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0151934', 'cui_str': 'Hypogeusia'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0430616', 'cui_str': 'Active anterior rhinomanometry'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}]",30.0,0.0947609,"Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters.","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Savietto', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Marioni', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Maculan', 'Affiliation': 'Department of Cardiac Thoracic and Vascular Sciences and Public Health, Hygiene and Public Health Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pettorelli', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scarpa', 'Affiliation': 'Department of Statistical Sciences, University of Padova, Padova, Italy; Department of Mathematics ""Tullio Levi-Civita"", University of Padova, Padova, Italy.'}, {'ForeName': 'Edi', 'Initials': 'E', 'LastName': 'Simoni', 'Affiliation': 'Department of Neuroscience, Bioacoustics Research Laboratory, University of Padova, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Astolfi', 'Affiliation': 'Department of Neuroscience, Bioacoustics Research Laboratory, University of Padova, Padova, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Marchese-Ragona', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Ottaviano', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy. Electronic address: giancarlo.ottaviano@unipd.it.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102502']
1278,32463701,Effects of Transcranial Direct Current Stimulation on Visual Neuroplasticity in Schizophrenia.,"People with schizophrenia (SZ) exhibit visual processing abnormalities that affect their daily functioning and remediating these deficits might help to improve functioning. Transcranial direct current stimulation (tDCS) is a potential tool for perceptual enhancement for this purpose, though there are no reports of tDCS applied to visual cortex in SZ. In a within-subject, crossover design, we evaluated the effects of tDCS on visual processing in 27 SZ. All patients received anodal, cathodal, or sham stimulation over the central occipital region in 3 visits separated by 1 week. In each visit, a backward masking task and an electroencephalography measure of visual neuroplasticity were administered after tDCS. Neuroplasticity was assessed with visual evoked potentials before and after tetanizing visual high-frequency stimulation. Masking performance was significantly poorer in the anodal and cathodal conditions compared with sham. Both anodal and cathodal stimulation increased the amplitude of P1 but did not change the plasticity index. We found significant plasticity effects of tDCS for only one waveform for one stimulation condition (P2 for anodal tDCS) which did not survive correction for multiple comparisons. The reason for the lack of tDCS stimulation effects on plasticity may be because tDCS was not delivered simultaneously with the tetanizing visual stimulus. The present findings emphasize the need for more research on the relevant parameters for stimulation of visual processing regions in clinical populations.",2020,We found significant plasticity effects of tDCS for only one waveform for one stimulation condition (P2 for anodal tDCS) which did not survive correction for multiple comparisons.,"['27 SZ', 'People with schizophrenia (SZ', 'Schizophrenia']","['Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', 'tDCS', 'anodal, cathodal, or sham stimulation']","['Visual Neuroplasticity', 'amplitude of P1', 'Neuroplasticity', 'visual processing', 'Masking performance']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0589087', 'cui_str': 'Visual processing'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]",,0.0630777,We found significant plasticity effects of tDCS for only one waveform for one stimulation condition (P2 for anodal tDCS) which did not survive correction for multiple comparisons.,"[{'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Jahshan', 'Affiliation': 'Mental Illness Research, Education and Clinical Center (MIRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Wynn', 'Affiliation': 'Mental Illness Research, Education and Clinical Center (MIRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'San Francisco Department of Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'San Francisco Department of Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'Mental Illness Research, Education and Clinical Center (MIRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}]",Clinical EEG and neuroscience,['10.1177/1550059420925697']
1279,32472663,Effects and Mechanisms of Transcutaneous Electrical Acustimulation on Postoperative Recovery After Elective Cesarean Section.,"OBJECTIVES


To explore the effects and mechanisms of transcutaneous electrical acustimulation (TEA) on postoperative recovery after cesarean section (CS).
MATERIALS AND METHODS


A total of 108 women who underwent CS were randomized to receive TEA or sham-TEA. Four hours after CS, electrogastrogram (EGG) and electrocardiogram (ECG) were recorded for 30 min to assess gastric slow waves and autonomic functions, respectively. TEA at ST36 or sham-TEA at non-acupoints was performed for one hour right after recording ECG and EGG and then twice daily from postoperative days (POD) 1 to 3. In the morning of POD4, the EGG and ECG were recorded again for 30 min.
RESULTS


TEA enhanced postoperative recovery associated with lower GI motility, reflected as a reduction in time of first flatus (p = 0.002) and time of first defecation (p < 0.001), an increase in the Bristol stool score (p < 0.001) and the number of SBMs (p < 0.001) in comparison with sham-TEA. TEA reduced symptoms associated with upper GI motility, including a reduction in time to resume semifluid (p = 0.008), and the total score of loss of appetite (p = 0.003) and belching (p = 0.038) from POD1 to POD3. Physiologically, TEA but not sham-TEA increased the percentage of normal gastric slow waves on POD4 compared with POD0 (p = 0.001). TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001). TEA but not sham-TEA increased vagal activity (p = 0.013) and decreased sympathetic activity (p = 0.013) on POD4 compared with POD0. Two factors were found to be independent predictors of shortened time of the first defecation: the use of TEA and a shorter surgical duration.
CONCLUSIONS


Needleless non-invasive TEA at ST36 is effective in promoting both lower and upper GI symptoms after CS by enhancing vagal and suppressing sympathetic activities [Correction added on 23 June 2020, after first online publication: The first word of the preceded sentence has been corrected.].",2020,TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001).,"['after cesarean section (CS', '108 women who underwent CS']","['transcutaneous electrical acustimulation (TEA', 'TEA', 'TEA at ST36 or sham-TEA', 'TEA or sham-TEA', 'Transcutaneous Electrical Acustimulation']","['Postoperative Recovery', 'number of SBMs', 'sympathetic activity', 'visual analogue scale (VAS) pain score from POD1 to POD3', 'postoperative recovery', 'vagal activity', 'Bristol stool score', 'percentage of normal gastric slow waves on POD4', 'time to resume semifluid', 'belching', 'total score of loss of appetite', 'time of first flatus', 'electrogastrogram (EGG) and electrocardiogram (ECG', 'time of first defecation']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C4523797', 'cui_str': 'Electrogastrogram'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",108.0,0.194432,TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001).,"[{'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Division of Gastroenterology, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Yinfang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Jingfei', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jiande', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13178']
1280,32470492,Mediators of the effects of canagliflozin on kidney protection in patients with type 2 diabetes.,"Canagliflozin reduced kidney disease progression in participants with type 2 diabetes in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program. This analysis explored potential mediators of the effects of canagliflozin on kidney outcomes. The percent mediating effect of 18 biomarkers indicative of disease was determined by comparing the hazard ratios for the effect of randomized treatment from an unadjusted model and from a model adjusting for the average post-randomization level of each biomarker. Multivariable analyses assessed the joint effects of biomarkers that mediated most strongly in univariable analyses. The kidney outcome was defined as a composite of 40% estimated glomerular filtration rate decline, end-stage kidney disease, or death due to kidney disease. Nine biomarkers (systolic blood pressure [8.9% of effect explained], urinary albumin:creatinine ratio [UACR; 23.9%], gamma glutamyltransferase [4.1%], hematocrit [51.1%], hemoglobin [41.3%], serum albumin [19.5%], erythrocytes [56.7%], serum urate [35.4%], and urine pH [7.5%]) individually mediated the effect of canagliflozin on the kidney outcome. In a parsimonious multivariable model, erythrocyte concentration, serum urate, and systolic blood pressure maximized cumulative mediation (115%). Mediating effects of UACR, but not other mediators, were highly dependent upon the baseline level of UACR: UACR mediated 42% and 7% of the effect in those with baseline UACR 30 mg/g or more and under 30 mg/g, respectively. The identified mediators support existing hypothesized mechanisms for the prevention of kidney outcomes with sodium glucose co-transporter 2 inhibitors. Thus, the disparity in mediating effects across baseline UACR subgroups suggests that the mechanism for kidney protection with canagliflozin may vary across patient subgroups.",2020,"Mediating effects of UACR, but not other mediators, were highly dependent upon the baseline level of UACR: UACR mediated 42% and 7% of the effect in those with baseline UACR 30 mg/g or more and under 30 mg/g, respectively.","['participants with type 2 diabetes in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program', 'patients with type 2 diabetes']","['Canagliflozin', 'UACR', 'canagliflozin']","['erythrocyte concentration, serum urate, and systolic blood pressure maximized cumulative mediation', 'kidney protection', 'serum albumin', 'serum urate', 'urinary albumin:creatinine ratio [UACR; 23.9%], gamma glutamyltransferase', 'hematocrit', 'glomerular filtration rate decline, end-stage kidney disease, or death due to kidney disease', 'hemoglobin', 'kidney disease progression', 'Nine biomarkers (systolic blood pressure']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0810127,"Mediating effects of UACR, but not other mediators, were highly dependent upon the baseline level of UACR: UACR mediated 42% and 7% of the effect in those with baseline UACR 30 mg/g or more and under 30 mg/g, respectively.","[{'ForeName': 'JingWei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia; Department of Cardiology, Xinqiao Hospital, Army Military Medical University, Chongqing, China; Department of Cardiology, People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Imperial College London, London, UK.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Simpson', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center, Groningen, The Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",Kidney international,['10.1016/j.kint.2020.04.051']
1281,32473765,Outcomes of orthodontic treatment performed by individual orthodontists vs 2 orthodontists collaborating on treatment.,"INTRODUCTION


One factor that can affect treatment outcomes is the treatment provider, and this factor has not been extensively studied. This research aimed to evaluate orthodontic treatment quality, length, and efficiency when 2 orthodontists collaborated on treatment, compared with the treatment provided solely by either orthodontist.
METHODS


A total of 150 consecutively treated subjects were divided into 3 equal groups based on the treating clinician. Patients in group A were treated by orthodontist A, group B by orthodontist B, and group C by both orthodontists in collaboration. The Peer Assessment Rating (PAR), Index of Complexity, Outcome, and Need (ICON), American Board of Orthodontics-Discrepancy Index, and American Board of Orthodontics-Cast and Radiographic Evaluation were used to assess the pretreatment and posttreatment status. Patient age, gender, type of malocclusion, extraction treatment, orthognathic surgery, treatment length, number of visits, and treatment efficiency index were assessed.
RESULTS


Posttreatment PAR and ICON indices showed excellent results in all 3 groups. American Board of Orthodontics-Cast and Radiographic Evaluation was significantly higher in group C (25.3 points) than in group A (21.5 points) or group B (22.0 points) (P = 0.014). Patients in group A had significantly shorter treatment time (23 months) than those in either group B or C (26 months) (P = 0.011). Patients in group C required more appointments (27 visits) than those in either group A or B (23 and 25 visits, respectively). The treatment efficiency index showed no statistically significant difference among the 3 groups.
CONCLUSIONS


There was no difference in treatment quality among the 3 groups, as assessed by the PAR index and ICON. Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist. Complex cases required 6 to 7 more months when they were treated collaboratively.",2020,Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist.,['A total of 150 consecutively treated subjects'],[],"['shorter treatment time', 'Peer Assessment Rating (PAR), Index of Complexity, Outcome, and Need (ICON), American Board of Orthodontics-Discrepancy Index, and American Board of Orthodontics-Cast and Radiographic Evaluation', 'PAR index and ICON', 'treatment quality', 'higher American Board of Orthodontics-Cast and Radiograph Evaluation scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429164', 'cui_str': 'Peer assessment rating (orthodontic index)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.0151119,Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist.,"[{'ForeName': 'Suliman A', 'Initials': 'SA', 'LastName': 'Alsaeed', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada; College of Dentistry, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: alsaeeds@mail.ubc.ca.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Kennedy', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada; Private Practice, Vancouver and Richmond, British Columbia, Canada.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Aleksejuniene', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Yen', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Pliska', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Donal C', 'Initials': 'DC', 'LastName': 'Flanagan', 'Affiliation': 'Private Practice, Vancouver and Delta, British Columbia, Canada.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.015']
1282,32474979,Isometric exercises do not provide immediate pain relief in Achilles tendinopathy: A quasi-randomized clinical trial.,"BACKGROUND


Isometric exercises may provide an immediate analgesic effect in patients with lower-limb tendinopathy and have been proposed as initial treatment and for immediate pain relief. Current evidence is conflicting, and previous studies were small.
OBJECTIVE


To study whether isometric exercises result in an immediate analgesic effect in patients with chronic midportion Achilles tendinopathy.
METHODS


Patients with clinically diagnosed chronic midportion Achilles tendinopathy were quasi-randomized to one of four arms: isometric calf-muscle exercises (tiptoes), isometric calf-muscle exercises (dorsiflexed ankle position), isotonic calf-muscle exercises, or rest. The primary outcome was pain measured on a visual analogue scale (VAS) score (0-100) during a functional task (10 unilateral hops) both before and after the intervention. Between-group differences were analyzed using a generalized estimation equations model.
RESULTS


We included 91 patients. There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7. There were also no between-group differences after the interventions.
CONCLUSION


The isometric exercises investigated in this study did not result in immediate analgesic benefit in patients with chronic midportion Achilles tendinopathy. We do not recommend isometric exercises if the aim is providing immediate pain relief. Future research should focus on the use of isometric or isotonic exercise therapy as initial treatment as all exercise protocols used in this study were well-tolerated.",2020,"There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7.","['patients with chronic midportion Achilles tendinopathy', '91 patients', 'Achilles', 'tendinopathy', 'Patients with clinically diagnosed chronic midportion Achilles tendinopathy', 'patients with lower-limb tendinopathy']","['Isometric exercises', 'isotonic exercise therapy', 'isometric calf-muscle exercises (tiptoes), isometric calf-muscle exercises (dorsiflexed ankle position), isotonic calf-muscle exercises, or rest', 'isometric exercises']","['pain measured on a visual analogue scale (VAS)-score (0-100) during a functional task (10 unilateral hops', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0950959', 'cui_str': 'Dorsiflex'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}]",91.0,0.139609,"There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7.","[{'ForeName': 'Arco C', 'Initials': 'AC', 'LastName': 'van der Vlist', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter L J', 'Initials': 'PLJ', 'LastName': 'van Veldhoven', 'Affiliation': 'Department of Sports Medicine, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'van Oosterom', 'Affiliation': 'Department of Sports Medicine, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Jan A N', 'Initials': 'JAN', 'LastName': 'Verhaar', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13728']
1283,32480307,Prolonged-release melatonin in Parkinson's disease patients with a poor sleep quality: A randomized trial.,"BACKGROUND


The present study was a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of prolonged-release melatonin (PRM) in Parkinson's disease (PD) patients with poor sleep quality.
METHODS


PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score > 5 were included. Patients were assessed using the PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale (UPDRS)-III at the beginning of the study and after 4 weeks of treatment with 2 mg of PRM. Partial correlation analysis was performed to investigate the relationship between PSQI score and the other scales.
RESULTS


Thirty-four PD patients with poor sleep quality were enrolled and divided into 2 groups based on medication; PRM (n = 16) and placebo (n = 18). Regarding efficacy, PSQI was significantly improved in the PRM group compared to the control group. Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group. PSQI improvement correlated with improvement in NMSS score and PDQ-39 summary index. Regarding safety, all enrolled subjects did not complain of side effects due to PRM.
CONCLUSION


PRM is an effective and safe treatment option for subjective sleep quality in PD patients and beneficial effects on sleep quality are associated with improved non-motor symptoms and quality of life in PD patients.",2020,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"['PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score', 'Thirty-four PD patients with poor sleep quality', ""Parkinson's disease (PD) patients with poor sleep quality"", '\xa05 were included', ""Parkinson's disease patients with a poor sleep quality""]","['Prolonged-release melatonin', 'prolonged-release melatonin (PRM', 'PRM', 'placebo']","['subjective sleep quality', ""PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale"", 'efficacy, PSQI', 'NMSS and PDQ-39 summary index', 'efficacy and safety', 'NMSS score and PDQ-39 summary index', 'UPDRS-III score']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0488383,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"[{'ForeName': 'Jong Hyeon', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Minkyeong', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Suyeon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, Soonchunhyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Wooyoung', 'Initials': 'W', 'LastName': 'Jang', 'Affiliation': 'Department of Neurology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Jinse', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Haeundae Paik Hospital, Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Eungseok', 'Initials': 'E', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Chungnam National University Hospital, College of Medicine, Daejun, Republic of Korea.'}, {'ForeName': 'Jin Whan', 'Initials': 'JW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: sunnyfor@hanmail.net.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Youn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: genian@skku.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.03.029']
1284,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1285,32486864,Robot-Assisted Laparoscopic Partial Nephrectomy  Vs  Conventional Laparoscopic Partial Nephrectomy: Functional and Surgical Outcomes of a Prospective Single Surgeon Randomized Study.,"Background:  Laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (RAPN) are commonly used techniques for treating small renal masses. Regarding renal function (RF) preservation, no superiority of one technique over the other has yet been definitely demonstrated.  Objective:  To compare functional and surgical outcomes of LPN and RAPN.  Patients and Methods:  Between 2015 and 2019, we prospectively randomized 115 patients with cT1-T2 renal masses to LPN in total ischemia or RAPN in selective ischemia. Primary endpoint was RF preservation, assessed by renal scintigraphy (RS). RS assessments were performed preoperatively and at 6 months follow-up. Secondary endpoints included clinical, histopathologic, and surgical outcomes.  Results:  One hundred eight patients were included in the final analysis. Patient and tumor characteristics were comparable. No significant difference in RS values after 6 months was observed between both groups. Median (interquartile range) RF change after 6 months was -18.0% (-26.5 to -11.0) in LPN group and -20.0 (-33.2 to -12.0) in RAPN group ( p  = 0.3). Mean (standard deviation [SD]) warm ischemia time was 21.1 (6.1) minutes in LPN group and 19.6 (7.7) minutes in RAPN group ( p  = 0.2). No positive surgical margins (PSMs) occurred in the LPN group, whereas RAPN group had PSM in 4.9% ( n  = 3);  p  = 0.099. Renal volume loss after 6 months was 27.5% (22.7-45.7) in the LPN group  vs  37.5 (13.7-54.2) in the RAPN group ( p  = 0.5). Mean operative times were lower in the LPN group (192.3 minutes [SD 44.5]  vs  230.2 minutes [SD 59.6],  p  = 0.001). More complications occurred in the LPN group (31%  vs  21%,  p  = 0.075). Transfusion rates were 15% for LPN and 11% for RAPN.  Conclusions:  In terms of preserving RF, LPN in total ischemia and RAPN in selective ischemia are comparable. In most patients, RF decrease of the affected kidney after PN seems to not exceed 25%, regardless of the surgical approach.",2020,"Mean operative times were lower in the LPN group (192.3 min (SD 44.5) versus 230.2 min (SD 59.6), p=0.001).","['115 patients with cT1-T2 renal masses to LPN in total ischemia or RAPN in selective ischemia', 'Total Ischemia', '108 patients were included in the final analysis', 'Patients/Methods Between 2015 and 2019']","['RAPN', 'LPN', ' Laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (RAPN', 'Conventional Laparoscopic Partial Nephrectomy', 'Robot-assisted Laparoscopic Partial Nephrectomy', 'LPN and RAPN']","['Mean (SD) warm ischemia time', 'More complications', 'Median (IQR) RF change', 'positive surgical margins (PSM', 'Renal volume loss', 'Mean operative times', 'RF preservation, assessed by renal scintigraphy (RS', 'clinical, histopathological and surgical outcomes', 'Transfusion rates', 'RS values']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C4039858', 'cui_str': 'Robot assisted laparoscopic partial nephrectomy'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C4039858', 'cui_str': 'Robot assisted laparoscopic partial nephrectomy'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1563923', 'cui_str': 'Warm Ischemic Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1310550', 'cui_str': 'Pteroylpoly-gamma-glutamate carboxypeptidase'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",115.0,0.0746323,"Mean operative times were lower in the LPN group (192.3 min (SD 44.5) versus 230.2 min (SD 59.6), p=0.001).","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Würnschimmel', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Giovanni Battista', 'Initials': 'GB', 'LastName': 'Di Pierro', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Grande', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Baumeister', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Roth', 'Affiliation': 'Klinik für Radiologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Mordasini', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Mattei', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}]",Journal of endourology,['10.1089/end.2020.0143']
1286,32484754,Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial.,"PURPOSE


The oligometastatic paradigm hypothesizes that patients with a limited number of metastases may achieve long-term disease control, or even cure, if all sites of disease can be ablated. However, long-term randomized data that test this paradigm are lacking.
METHODS


We enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to stereotactic ablative radiotherapy (SABR). We stratified by the number of metastases (1-3  v  4-5) and randomized in a 1:2 ratio between palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR (arm 2). We used a randomized phase II screening design with a primary end point of overall survival (OS), using an α of .20 (wherein  P  < .20 indicates a positive trial). Secondary end points included progression-free survival (PFS), toxicity, and quality of life (QOL). Herein, we present long-term outcomes from the trial.
RESULTS


Between 2012 and 2016, 99 patients were randomly assigned at 10 centers internationally. The most common primary tumor types were breast (n = 18), lung (n = 18), colorectal (n = 18), and prostate (n = 16). Median follow-up was 51 months. The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank  P  = .006). The 5-year PFS rate was not reached in arm 1 (3.2%; 95% CI, 0% to 14% at 4 years with last patient censored) and 17.3% in arm 2 (95% CI, 8% to 30%;  P  = .001). There were no new grade 2-5 adverse events and no differences in QOL between arms.
CONCLUSION


With extended follow-up, the impact of SABR on OS was larger in magnitude than in the initial analysis and durable over time. There were no new safety signals, and SABR had no detrimental impact on QOL.",2020,"The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank  P  = .006).","['99 patients were randomly assigned at 10 centers internationally', 'patients with a limited number of metastases', 'Oligometastatic Cancers', 'Between 2012 and 2016', 'enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to']","['stereotactic ablative radiotherapy (SABR', 'Stereotactic Ablative Radiotherapy', 'palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR', 'SABR']","['5-year PFS rate', 'QOL', '5-year OS rate', 'overall survival (OS', 'progression-free survival (PFS), toxicity, and quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0449798', 'cui_str': 'Number of metastases'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",99.0,0.206806,"The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank  P  = .006).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Olson', 'Affiliation': 'BC Cancer, Centre for the North, Prince George, British Columbia, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrow', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Gaede', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Haasbeek', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Mulroy', 'Affiliation': 'Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Yaremko', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Schellenberg', 'Affiliation': 'BC Cancer, Surrey Centre, Surrey, British Columbia, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Sashendra', 'Initials': 'S', 'LastName': 'Senthi', 'Affiliation': 'Alfred Health Radiation Oncology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaminath', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kopek', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BC Cancer, Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Currie', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Schlijper', 'Affiliation': 'BC Cancer, Centre for the North, Prince George, British Columbia, Canada.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Bauman', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Laba', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'X Melody', 'Initials': 'XM', 'LastName': 'Qu', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00818']
1287,32485785,"Stem cell mobilization with plerixafor and healing of diabetic ischemic wounds: A phase IIa, randomized, double-blind, placebo-controlled trial.","Bone marrow-derived cells contribute to tissue repair, but traffic of hematopoietic stem/progenitor cells (HSPCs) is impaired in diabetes. We therefore tested whether HSPC mobilization with the CXCR4 antagonist plerixafor improved healing of ischemic diabetic wounds. This was a pilot, phase IIa, double-blind, randomized, placebo-controlled trial (NCT02790957). Patients with diabetes with ischemic wounds were randomized to receive a single subcutaneous injection of plerixafor or saline on top of standard medical and surgical therapy. The primary endpoint was complete healing at 6 months. Secondary endpoints were wound size, transcutaneous oxygen tension (TcO 2  ), ankle-brachial index (ABI), amputations, and HSPC mobilization. Twenty-six patients were enrolled: 13 received plerixafor and 13 received placebo. Patients were 84.6% males, with a mean age of 69 years. HSPC mobilization was successful in all patients who received plerixafor. The trial was terminated after a preplanned interim analysis of 50% of the target population showed a significantly lower healing rate in the plerixafor vs the placebo group. In the final analysis data set, the rate of complete healing was 38.5% in the plerixafor group vs 69.2% in the placebo group (chi-square P = .115). Wound size tended to be larger in the plerixafor group for the entire duration of observation. No significant difference was noted for the change in TcO 2  and ABI or in amputation rates. No other safety concern emerged. In conclusion, successful HSPC mobilization with plerixafor did not improve healing of ischemic diabetic wounds. Contrary to what was expected, outside the context of hematological disorders, mobilization of diabetic HSPCs might exert adverse effects on wound healing.",2020,No significant difference was noted for the change in TcO 2  and ABI or in amputation rates.,"['Twenty-six patients were enrolled: 13 received', 'diabetic ischemic wounds', 'Patients were 84.6% males, with a mean age of 69\u2009years', 'Patients with diabetes with ischemic wounds']","['CXCR4 antagonist plerixafor', 'plerixafor', 'plerixafor or saline', 'placebo']","['HSPC mobilization', 'healing rate', 'healing of ischemic diabetic wounds', 'rate of complete healing', 'Wound size', 'complete healing', 'change in TcO 2  and ABI or in amputation rates', 'wound size, transcutaneous oxygen tension (TcO 2  ), ankle-brachial index (ABI), amputations, and HSPC mobilization']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4761249', 'cui_str': 'Ischaemic wound'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C4728046', 'cui_str': 'Diabetic wound'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1863925', 'cui_str': 'Nonmedullary thyroid carcinoma, with or without cell oxyphilia'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}]",26.0,0.472383,No significant difference was noted for the change in TcO 2  and ABI or in amputation rates.,"[{'ForeName': 'Benedetta Maria', 'Initials': 'BM', 'LastName': 'Bonora', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cappellari', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mazzucato', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Rigato', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Menegolo', 'Affiliation': 'Department of Cardiothoracic and Vascular Sciences, University of Padova, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruttocao', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Avogaro', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Gian Paolo', 'Initials': 'GP', 'LastName': 'Fadini', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}]",Stem cells translational medicine,['10.1002/sctm.20-0020']
1288,32584893,Effectiveness of a digital device providing real-time visualized tooth brushing instructions: A randomized controlled trial.,"INTRODUCTION


The aim of this trial was to investigate whether a digital device that provides real-time visualized brushing instructions would contribute to the removal of dental plaque over usual brushing instructions.
METHODS


We conducted a single-center, parallel-group, stratified permuted block randomized control trial with 1:1 allocation ratio. Eligibility criteria included people aged ≥ 18 years, and exclude people who met the following criteria: severely crowded teeth; using interdental cleaning implement; having external injury in the oral cavity, or stomatitis; having less than 20 teeth; using orthodontic apparatus; visited to a dental clinic; having the possibility of consulting a dental clinic; having a dental license; not owning a smartphone or tablet device; smoker; taken antibiotics; pregnant; an allergy to the staining fluid; and employee of Sunstar Inc. All participants received tooth brushing instructions using video materials and were randomly assigned to one of two groups for four weeks: (1) an intervention group who used the digital device, providing real-time visualized instructions by connection with a mobile application; and (2) a control group that used a digital device which only collected their brushing logs. The primary outcome was the change in 6-point method plaque control record (PCR) score of all teeth between baseline and week 4. The t-test was used to compare the two groups in accordance with intention-to-treat principles.
RESULTS


Among 118 enrolled individuals, 112 participants were eligible for our analyses. The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07).
CONCLUSIONS


A digital device providing real-time visualized brushing instructions may be effective for the removal of dental plaque.",2020,"The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07).
","['118 enrolled individuals', '112 participants were eligible for our analyses', 'Eligibility criteria included people aged ≥ 18 years, and exclude people who met the following criteria: severely crowded teeth; using interdental cleaning implement; having external injury in the oral cavity, or stomatitis; having less than 20 teeth; using orthodontic apparatus; visited to a dental clinic; having the possibility of consulting a dental clinic; having a dental license; not owning a smartphone or tablet device; smoker; taken antibiotics; pregnant; an allergy to the staining fluid; and employee of Sunstar Inc']","['intervention group who used the digital device, providing real-time visualized instructions by connection with a mobile application; and (2) a control group that used a digital device which only collected their brushing logs', 'digital device providing real-time visualized tooth brushing instructions']","['change in 6-point method plaque control record (PCR) score of all teeth', 'mean of PCR score', 'change of PCR score']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040433', 'cui_str': 'Crowding of teeth'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0443212', 'cui_str': 'External injury'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",118.0,0.27291,"The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07).
","[{'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Shida', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Satoe', 'Initials': 'S', 'LastName': 'Okabayashi', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Oral Health Sciences, Faculty of Health and Welfare, Tokushima Bunri University, Tokushima, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishiura', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Okazawa', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kiyohara', 'Affiliation': ""Department of Food Science, Otsuma Women's University, Tokyo, Japan.""}, {'ForeName': 'Manako', 'Initials': 'M', 'LastName': 'Konda', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Nishioka', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Iwami', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}]",PloS one,['10.1371/journal.pone.0235194']
1289,32590010,Bacterial skin recolonization in the operating room: comparison between various antisepsis protocols.,"BACKGROUND


Surgical site infection (SSI) largely implicates the patient's endogenous skin microbiota. Perioperative disinfection protocols do not follow a general agreement.
AIM


To compare antisepsis and skin protection protocols on quantitative analysis of recolonization in the operating room at regular time-steps. The study hypothesis was that one protocol would be more effective than others.
METHODS


A single-centre prospective interventional study was conducted between January and June 2019. Healthy volunteers were randomized between protocols and served as their own controls. The protocols began ahead of scheduled orthopaedic surgery with a preoperative shower, mechanical cleansing, application of major antiseptics (alcoholic Bétadine™ 5% or alcoholic chlorhexidine 0.5%), sterile draping, then adhesive draping (3M™ Steri-Drape™ or iodine-impregnated 3M™ Ioban2™). Sampling was by swabbing in the operating room at 30 min intervals up to 90 min after draping. Cultures were performed under aerobic and anaerobic conditions. Qualitative and quantitative (cfu/mL) bacteriology was performed in the laboratory by direct reading on the blood agar plates.
FINDINGS


Thirty subjects were included; none was lost to follow-up or excluded from analysis. Bacterial load before manipulation (T0) was significantly higher in males (P < 0.0001) despite a significantly shorter shower-to-sampling interval (P = 0.03). Smoking (P = 0.85), body mass index (P = 0.38), and depilation (P = 0.50) did not significantly affect preoperative load. Mean load increased significantly under all protocols up to T90 min, without significant superiority for any one protocol. Associated Bétadine™/Ioban™ showed the lowest T90 load, and chlorhexidine alone the highest, but without significant difference. Isolates at T0 were predominantly healthy skin commensals: coagulase-negative staphylococci, micrococci, and coryneforms.
CONCLUSION


No one protocol demonstrated superiority, whether in immediate bactericidal action or in preventing skin recolonization in the operating room. Further studies are needed to define generally agreed protocols for SSI risk management.",2020,"Associated Bétadine™/Ioban™ showed the lowest T90 load, and chlorhexidine alone the highest, but without significant difference.","['A single-centre prospective interventional study was conducted between January and June 2019', 'Thirty subjects were included; none was lost to follow-up or excluded from analysis', 'Healthy volunteers']","['Steri-Drape™ or iodine-impregnated 3M™ Ioban2™', 'chlorhexidine', 'scheduled orthopaedic surgery with a preoperative shower, mechanical cleansing, application of major antiseptics (alcoholic Bétadine™ 5% or alcoholic chlorhexidine 0.5%), sterile draping, then adhesive draping (3M™']","['body mass index', 'Qualitative and quantitative (cfu/mL', 'Mean load', 'Bacterial load before manipulation (T0', 'Bacterial skin recolonization', 'skin recolonization']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0950000', 'cui_str': 'Silene'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1275716', 'cui_str': 'Application of surgical drapes'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",30.0,0.0209764,"Associated Bétadine™/Ioban™ showed the lowest T90 load, and chlorhexidine alone the highest, but without significant difference.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rouquette', 'Affiliation': 'Université Clermont Auvergne et associés, Clermont Ferrand, France. Electronic address: lorouquett@gmail.com.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Traore', 'Affiliation': ""CHU Clermont Ferrand, Service d'Hygiène Hospitalière, Clermont Ferrand, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Descamps', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boisgard', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Villatte', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Erivan', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}]",The Journal of hospital infection,['10.1016/j.jhin.2020.06.014']
1290,32591219,Cognitive Behavioral Sex Therapy: An Emerging Treatment Option for Nonorganic Erectile Dysfunction in Young Men: A Feasibility Pilot Study.,"INTRODUCTION


An increasing number of young men have been found to develop nonorganic erectile dysfunction (NOED) in recent years. The NOED has been shown to respond better to cognitive behavior sex therapy (CBST) in a few past studies.
AIM


The present research aims to establish the efficacy of CBST as a promising treatment option in young men suffering from NOED by administering a feasibility pilot trial.
METHODS


28 young men (M = 31 years) out of a total of 39 men (7 excluded, 4 quit treatment) diagnosed with NOED from sexual health clinics in Pakistan were recruited to receive CBST treatment (n = 13) on average twice a week for a period of 50 minutes per session for a period of 4, 6, 8, and 12 weeks for the mild, mild to moderate, moderate, and severe forms of NOED, respectively, and sildenafil citrate group (n = 15) receiving sildenafil citrate 50 mg on demand. The trial design was sequential random assignment clinical trial.
MAIN OUTCOME MEASURES


International Index of Erectile Functoning-5 and Depression Anxiety Stress Scale-21 were used before treatment, after treatment, and in follow-up as the main outcome measures.
RESULTS


The repeated measures analysis of covariance established a nonsignificant difference between CBST and sildenafil citrate 50 mg in NOED scores improvement, NOED severity reduction, and reduction in depression scores at posttreatment assessment. There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores. There was significant difference in CBST and sildenafil citrate 50 mg in anxiety reduction at posttreatment assessment. The covariates age, age groups, and NOED duration did not significantly impact the treatment outcome for both treatment groups except age which impacted the interaction of treatment and anxiety scores.
CONCLUSION


The CBST is an emerging and promising treatment choice in younger men suffering from NOED. Bilal A, Abbasi NuH. Cognitive Behavioral Sex Therapy: An Emerging Treatment Option for Nonorganic Erectile Dysfunction in Young Men: A Feasibility Pilot Study. J Sex Med 2020;8:396-407.",2020,"There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores.","['28 young men (M\xa0', 'Young Men', 'young men suffering from NOED', '31\xa0years) out of a total of 39 men (7 excluded, 4 quit treatment) diagnosed with NOED from sexual health clinics in Pakistan', 'younger men suffering from NOED']","['Cognitive Behavioral Sex Therapy', 'Abbasi NuH. Cognitive Behavioral Sex Therapy', 'CBST and sildenafil citrate', 'CBST', 'CBST treatment', 'sildenafil citrate 50\xa0mg on demand', 'sildenafil citrate']","['NOED scores improvement, NOED severity reduction, and reduction in depression scores', 'CBST and sildenafil citrate 50', 'International Index of Erectile Functoning-5 and Depression Anxiety Stress Scale-21', 'anxiety reduction', 'anxiety scores', 'NOED scores, reduction in NOED severity, and depression scores']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",28.0,0.0202324,"There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Bilal', 'Affiliation': 'PhD Research Scholar, Department of Psychology, International Islamic University, Islamabad, Pakistan. Electronic address: ahmadbilal4@gmail.com.'}, {'ForeName': 'Najam Ul Hasan', 'Initials': 'NUH', 'LastName': 'Abbasi', 'Affiliation': 'Assistant Professor, Department of Psychology, International Islamic University, Islamabad, Pakistan.'}]",Sexual medicine,['10.1016/j.esxm.2020.05.005']
1291,32591246,"The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE's ""M1|RT Comparison"".","BACKGROUND


Prostate radiotherapy (RT) is a first-line option for newly diagnosed men with low-burden metastatic prostate cancer. The current criterion to define this clinical state is based on manual bone metastasis counts, but enumeration of bone metastases is limited by interobserver variations, and it does not account for metastasis volume or lesional coalescence. The automated bone scan index (aBSI) is a quantitative method of evaluating bone metastatic burden in a standardised and reproducible manner.
OBJECTIVE


To evaluate whether aBSI has utility as a predictive imaging biomarker to define a newly diagnosed metastatic prostate cancer population that might benefit from the addition of prostate RT to standard of care (SOC) systemic therapy.
DESIGN, SETTING, AND PARTICIPANTS


This is an exploratory analysis of men with newly diagnosed metastatic prostate cancer randomised in a 1:1 ratio to either SOC or SOC + prostate RT within the STAMPEDE ""M1|RT comparison"".
INTERVENTION


The SOC was lifelong androgen deprivation therapy, with up-front docetaxel permitted from December 2015. Men allocated RT received either a daily or a weekly schedule that was nominated before randomisation.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Baseline bone scans were evaluated retrospectively to calculate aBSI. We used overall (OS) and failure-free (FFS) survival as the end points. Treatment-aBSI interaction was evaluated using the multivariable fractional polynomial interaction (MFPI) and subpopulation treatment effect pattern plot. Further analysis was done in aBSI quartiles using Cox regression models adjusted for stratification factors.
RESULTS AND LIMITATIONS


Baseline bone scans for 660 (SOC: 323 and SOC + RT: 337) of 2061 men randomised within the ""M1|RT comparison"" met the software requirements for aBSI calculation. The median age was 68 yr, median PSA was 100 ng/mL, median aBSI was 0.9, and median follow-up was 39 mo. Baseline patient characteristics including aBSI were balanced between the treatment groups. Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure). Graphical evaluation of estimated treatment effect plots showed that the OS and FFS benefit from prostate RT was greatest in patients with a low aBSI. Further analysis in quartiles based on aBSI supported this finding.
CONCLUSIONS


A low automated bone scan index is predictive of survival benefit associated with prostate RT in men with newly diagnosed metastatic prostate cancer.
PATIENT SUMMARY


The widely used bone scan can be evaluated using an automated technique to potentially select men with newly diagnosed metastatic prostate cancer who might benefit from prostate radiotherapy.",2020,"Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure).","['men with newly diagnosed metastatic prostate cancer who might benefit from prostate radiotherapy', 'newly diagnosed men with low-burden metastatic prostate cancer', 'men with newly diagnosed metastatic prostate cancer randomised in a 1:1 ratio to either', 'men with newly diagnosed metastatic prostate cancer', 'patients with a low aBSI', 'Men with Newly Diagnosed Metastatic Prostate Cancer', 'newly diagnosed metastatic prostate cancer population', 'Baseline bone scans for 660 (SOC: 323 and SOC\u2009+\u2009RT: 337) of 2061 men']","['aBSI', 'Prostate Radiotherapy', 'Prostate radiotherapy (RT', 'SOC or SOC\u2009+\u2009prostate RT']","['aBSI', 'overall (OS) and failure-free (FFS) survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",2061.0,0.146123,"Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure).","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Hoyle', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK; Department of Urology, The Salford NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Amos', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Calvert', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Douis', 'Affiliation': 'Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Malcolm D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK; Department of Urology, The Salford NHS Foundation Trust, Manchester, UK. Electronic address: noel.clarke@christie.nhs.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology oncology,['10.1016/j.euo.2020.05.003']
1292,32639241,The 11th Trial of a Cardiovascular Clinical Trialist: Coronavirus-2: Part 2.,,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000328']
1293,32634486,Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.,"BACKGROUND


Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.
METHODS


This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).
DISCUSSION


AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).",2020,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","['Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups', 'adolescents with type 1 diabetes', 'patients with T1D often receive care in clinics and institutions with limited resources and time', ""middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population""]",[],"['patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0267749,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, United States of America.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ruelas', 'Affiliation': 'Keck School of Medicine, University of Southern California, United States of America.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ashwal', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""The Vision Center, Children's Hospital Los Angeles, United States of America.""}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'School of Pharmacy, University of Southern California, United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClain', 'Affiliation': 'School of Social Work, University of Southern California, United States of America.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Center for Endocrinology, Diabetes, & Metabolism, Children's Hospital Los Angeles, United States of America. Electronic address: jraymond@chla.usc.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106079']
1294,32634551,Effects of resistance training on hepcidin levels and iron bioavailability in older individuals with end-stage renal disease: A randomized controlled trial.,"Anemia is an inherent complication of older individuals with end-stage renal disease (ESRD) that is associated with inflammation which in turn is an important factor in the activation of hepcidin that contributes to the decrease in serum iron. Athough resistance training (RT) seems to reduce inflammation in ESRD, its influence on hepcidin and iron availability in hemodialysis patients is unclear. Therefore, the aim of this study was to exemine the effects of RT in on inflammatory profile, hepcidin, and iron status in older individuals with ESRD. End-stage renal disease patients (N: 157, age: 66.8 ± 3.6; body mass: 73 ± 15 body mass index:27 ± 3), were assigned to control (CTL n: 76) and exercise groups (RT n: 81). RT consisted of 24 weeks/3 days per week of a moderate intensity. There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile. These novel findings show that RT is a potential coadjuvant to reduce iron deficiency by decreasing the levels of hepcidin and pro-inflammatory markers in older patients undergoing hemodialysis.",2020,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","['N: 157, age: 66.8\u202f±\u202f3.6; body mass: 73\u202f±\u202f15 body mass index:27\u202f±\u202f3', 'older individuals with ESRD', 'older individuals with end-stage renal disease', 'older individuals with end-stage renal disease (ESRD', 'older patients undergoing hemodialysis', 'hemodialysis patients', 'End-stage renal disease patients']","['Athough resistance training (RT', 'RT', 'resistance training']","['inflammatory profile, hepcidin, and iron status', 'hepcidin levels and iron bioavailability', 'hepcidin levels', 'bioavailability of iron']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",157.0,0.0490397,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","[{'ForeName': 'Sting Ray Gouveia', 'Initials': 'SRG', 'LastName': 'Moura', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Hugo Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil. Electronic address: hugo.efucb@gmail.com.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Cláudio Avelino Rodrigues', 'Initials': 'CAR', 'LastName': 'Santos', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Luiz Sinésio Silva', 'Initials': 'LSS', 'LastName': 'Neto', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Fabiani Lage Rodrigues', 'Initials': 'FLR', 'LastName': 'Beal', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'University of Nevada, Las Vegas, Department of Kinesiology and Nutrition Sciences, Las Vegas, NV, USA.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'André Bonadias', 'Initials': 'AB', 'LastName': 'Gadelha', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil; Federal Institute of Education, Science and Technology Goiano, Goiás, Brazil.'}, {'ForeName': 'Thiago Dos Santos', 'Initials': 'TDS', 'LastName': 'Rosa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111017']
1295,32593717,Caring for older veterans with chronic low back pain using a geriatric syndrome approach: Rationale and methods for the aging back clinics (ABC) trial.,"The purpose of the ongoing trial is to improve care of older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6 months on ≥ half the days). Current CLBP care is limited by being either overly spine-focused or non-specifically prescribed and both approaches frequently lead to suboptimal reduction in pain and improvement in function. Through prior studies we have laid the foundation for a patient-centered approach to care for older Veterans with CLBP in which the spine is a source of vulnerability but not the sole treatment target. The approach considers CLBP a geriatric syndrome, a final common pathway for the expression of multiple contributors rather than a disease of the spine. We describe here the rationale and design of a randomized controlled trial to test the efficacy of an older Veteran-centered approach to CLBP care in ""Aging Back Clinics (ABCs)"" compared with Usual Care (UC). Three hundred thirty Veterans age 65-89 with CLBP will be randomized to ABCs or UC and followed for 12 months after randomization. We will assess the impact of ABCs on our primary outcome of pain-associated disability with the Oswestry Disability Index at 6 and 12 months, and secondary outcomes of pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization. If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.",2020,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","['Three hundred thirty Veterans age 65-89 with CLBP', 'older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6\u202fmonths on ≥ half the days', 'older veterans with chronic low back pain using a geriatric syndrome approach', 'older adults with CLBP']","['ABCs or UC', 'older Veteran-centered approach to CLBP care', 'Usual Care (UC']","['pain-associated disability with the Oswestry Disability Index', 'pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",330.0,0.0631505,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","[{'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America. Electronic address: debra.weiner@va.gov.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gentili', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Meika A', 'Initials': 'MA', 'LastName': 'Fang', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Garay', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Thiru', 'Initials': 'T', 'LastName': 'Annaswamy', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Castle', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Joseph', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lawson', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Una E', 'Initials': 'UE', 'LastName': 'Makris', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Rossi', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'University of Alabama, Tuscaloosa, AL, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Clemens', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Newman', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America; University of Pittsburgh Graduate School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106077']
1296,32594123,Comment on: Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study.,,2020,,['refractory Takayasu arteritis'],['tocilizumab'],[],"[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0039263', 'cui_str': ""Takayasu's disease""}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]",[],,0.0466438,,"[{'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'Department of Rheumatology, Osaki Citizen Hospital, Osaki.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa253']
1297,32594147,Comment on: Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study: reply.,,2020,,['refractory Takayasu arteritis'],['tocilizumab'],[],"[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0039263', 'cui_str': ""Takayasu's disease""}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]",[],,0.0443197,,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Nakaoka', 'Affiliation': 'Department of Vascular Physiology, National Cerebral and Cardiovascular Center Research Institute, Suita.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yamakido', 'Affiliation': 'Chugai Pharmaceutical Co. Ltd, Tokyo, Japan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa255']
1298,32594702,[Effects of two dimensional gray-scale blood flow imaging combined with color Doppler flow imaging in guiding arterial puncture and catheterization through wounds in patients with large burns].,"Objective:  To explore the effects of two dimensional gray-scale blood flow imaging (hereinafter referred to as "" B-flow"" ) combined with color Doppler flow imaging (CDFI) in guiding arterial puncture and catheterization through wounds in patients with large burns.  Methods:  Sixty-seven patients with large burns who met the inclusion criteria and hospitalized in the First Hospital of Jilin University from January 2017 to January 2019 were enrolled in the prospectively randomized control study. According to the random number table, CDFI alone group was allocated with 35 patients (23 males and 12 females) and B-flow+ CDFI group with 32 patients (22 males and 10 females), aged 19-60 and 18-58 years, respectively. According to the progress of the disease, arterial puncture and catheterization were performed in the right time. During the operation, CDFI was used alone for guidance in patients of CDFI alone group, while B-flow and CDFI were used together for guidance in patients of B-flow+ CDIF group. Based on the first time of catheterization, the catheterization location, one-time catheterization success rate, post-back stitching re-catheterization success rate, catheterization failure rate, catheterization duration, and incidences of wound sepsis, catheter-related bloodstream infection, and arterial thrombosis within post catheterization day (PCD) 3 of patients in the two groups were recorded. Data were statistically analyzed with the independent-sample  t  test, chi-square test or Fisher's exact probability test.  Results:  (1) All the patients underwent catheterization through wounds, and there was no statistically significant difference in catheterization location of patients between the two groups ( χ (2)=0.574,  P >0.05). The one-time catheterization success rate of patients in B-flow+ CDFI group was 81.25% (26/32), which was obviously higher than 51.43% (18/35) in CDFI alone group ( χ (2)=6.594,  P <0.05). The catheterization failure rate of patients in B-flow+ CDFI group was 3.12% (1/32), which was obviously lower than 20.00% (7/35) in CDFI alone group ( P <0.05). The post-back stitching re-catheterization success rate of patients was similar between the two groups ( χ (2)=1.029,  P >0.05). (3) The catheterization duration of patients was (15.7±1.1) min in B-flow+ CDFI group, which was obviously shorter than (17.1±2.2) min in CDFI alone group ( t =11.316,  P <0.01). (4) Within PCD 3, the incidences of wound sepsis and catheter-related bloodstream infection of patients in CDFI alone group were 2.86% (1/35) and 0, close to 0 and 3.12% (1/32) in B-flow+ CDFI group ( P >0.05); the incidence of arterial thrombosis of patients in B-flow+ CDFI group was 0, which was obviously lower than 20.00% (7/35) in CDFI alone group ( P <0.05).  Conclusions:  Compared with CDFI alone, B-flow combined with CDFI can improve the success rate of arterial puncture and catheterization through wounds in large area burn patients, shorten the catheterization duration, and effectively reduce the incidence of arterial thrombosis after catheterization, with a good clinical application value.",2020,", B-flow combined with CDFI can improve the success rate of arterial puncture and catheterization through wounds in large area burn patients, shorten the catheterization duration, and effectively reduce the incidence of arterial thrombosis after catheterization, with a good clinical application value.","['35 patients (23 males and 12 females) and B-flow+ CDFI group with 32 patients (22 males and 10 females), aged 19-60 and 18-58 years, respectively', 'Sixty-seven patients with large burns who met the inclusion criteria and hospitalized in the First Hospital of Jilin University from January 2017 to January 2019', 'patients with large burns']","['CDFI alone', 'CDFI', 'dimensional gray-scale blood flow imaging (hereinafter referred to as "" B-flow"" ) combined with color Doppler flow imaging (CDFI', 'dimensional gray-scale blood flow imaging combined with color Doppler flow imaging']","['incidence of arterial thrombosis', 'catheterization failure rate', 'incidences of wound sepsis and catheter-related bloodstream infection', 'time catheterization success rate', 'catheterization duration', 'catheterization location', 'catheterization location, one-time catheterization success rate, post-back stitching re-catheterization success rate, catheterization failure rate, catheterization duration, and incidences of wound sepsis, catheter-related bloodstream infection, and arterial thrombosis within post catheterization day (PCD', 'success rate of arterial puncture and catheterization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0522507', 'cui_str': 'With color'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1141927', 'cui_str': 'Wound sepsis'}, {'cui': 'C2886794', 'cui_str': 'Catheter related bloodstream infection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}]",67.0,0.0208289,", B-flow combined with CDFI can improve the success rate of arterial puncture and catheterization through wounds in large area burn patients, shorten the catheterization duration, and effectively reduce the incidence of arterial thrombosis after catheterization, with a good clinical application value.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Wu', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Zhang', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Chi', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Q Y', 'Initials': 'QY', 'LastName': 'Zhao', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20190309-00099']
1299,32602000,Contrast-enhanced ultrasonography and blue dye methods in detection of sentinel lymph nodes following neoadjuvant chemotherapy in initially node positive breast cancer.,"BACKGROUND


Recent studies show that contrast-enhanced ultrasonography (CEUS) using SonoVue has the potential to improve the performance of sentinel lymph node biopsy (SLNB) in patients with early breast cancer. However, the evidence of SLNB using CEUS in patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC) is lacking. The aim of this prospective study is to evaluate the feasibility of CEUS using SonoVue for the identification of sentinel lymph node (SLN) and the value of the combination of CEUS and blue dye (BD) for SLNB in patients converting from cN1 to cN0 following NAC.
METHODS


Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC. Patients converting from cN1 to cN0 following NAC were enrolled and randomized into two groups for SLNB: the combination method group using CEUS and BD together, and the single BD method group. Then all patients underwent complete axillary lymph node dissection (ALND) and primary breast surgery. Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
RESULTS


A total of 400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5%) patients had clinically negative node confirmed by imaging after NAC and randomized into two groups. Each group included 67 cases. In the combination method group, contrast-enhanced lymphatic vessels in 66 cases of 67 were clearly visualized by US soon after the periareolar injection of SonoVue and the SLNs were accurately localized. The identification rate of the combination method was 98.5%%, which was significantly higher than 83.6% (56/67) using the single BD method. The mean numbers of SLNs identified by the combination method was higher than that by the single BD method. Compared with pathological diagnosis, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method were 84.4%, 100%, 89.4%, 100%, 75%, and 15.6%, respectively. In contrast, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR using single blue dye were 73.9%, 100%, 89.3%, 100%, 84.6%, and 26.1%, respectively. The FNR using the combination method was significantly lower than that using single BD.
CONCLUSION


Identification of SLNs in patients converting from cN1 to cN0 following NAC by CEUS is a technically feasible. The combination of CEUS and BD is more effective than BD alone for SLNB in patients converting from cN1 to cN0 following NAC.",2020,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
","['initially node positive breast cancer', '400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5', 'Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC', 'patients converting from cN1 to cN0 following NAC', 'Patients converting from cN1 to cN0 following NAC', 'patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC', 'patients with early breast cancer']","['SLNB: the combination method group using CEUS', 'CEUS', 'CEUS and BD', 'CEUS and blue dye (BD', 'complete axillary lymph node dissection (ALND) and primary breast surgery', 'Contrast-enhanced ultrasonography and blue dye methods', 'neoadjuvant chemotherapy', 'contrast-enhanced ultrasonography (CEUS']","['identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value', 'mean numbers of SLNs', 'sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method', 'sensitivity, specificity, accuracy, the positive predictive value']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",400.0,0.0388999,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
","[{'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Breast Surgical Oncology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, No. 420 Fuma Road, Fuzhou, 350014, Fujian, People's Republic of China. wxf200104@hotmail.com.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Shixin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': ""Department of Clinical Laboratory, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': ""Department of Pathology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05646-8']
1300,32602079,Randomized controlled trial of single incision versus conventional multiport laparoscopic cholecystectomy with long-term follow-up.,"BACKGROUND


Within the last years, single-incision laparoscopic cholecystectomy (SLC) emerged as an alternative to multiport laparoscopic cholecystectomy (MLC). SLC has advantages in cosmetic results, and postoperative pain seems lower. Overall complications are comparable between SLC and MLC. However, long-term results of randomized trials are lacking, notably to answer questions about incisional hernia rates, long-term cosmetic impact and chronic pain.
METHODS


A randomized trial of SLC versus MLC with a total of 193 patients between December 2009 and June 2011 was performed. The primary endpoint was postoperative pain on the first day after surgery. Secondary endpoints were conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay. A long-term follow-up after surgery was added.
RESULTS


Ninety-eight patients (50.8%) underwent SLC, and 95 patients (49.2%) had MLC. Pain on the first postoperative day showed no difference between the operative procedures (SLC vs. MLC, 3.4 ± 1.8 vs. 3.7 ± 1.9, respectively; p = 0.317). No significant differences were observed in operating time or the overall rate of postoperative complications (4.1% vs. 3.2%; p = 0.731). SLC exhibited better cosmetic results in the short term. In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups.
CONCLUSIONS


Taking into account a follow-up rate of 68%, the early postoperative advantages of SLC in relation to cosmetic appearance and pain did not persist in the long term. In the present trial, there was no difference in incisional hernia rates between SLC and MLC, but the sample size is too small for a final conclusion regarding hernia rates.
TRIAL REGISTRATION


German Registry of Clinical Trials DRKS00012447.",2020,"In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups.
",['193 patients between December 2009 and June 2011 was performed'],"['single incision versus conventional multiport laparoscopic cholecystectomy', 'MLC', 'multiport laparoscopic cholecystectomy (MLC', 'SLC', 'incision laparoscopic cholecystectomy (SLC']","['cosmetic appearance and pain', 'incisional hernia rates', 'postoperative pain', 'Pain', 'MLC', 'conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay', 'Overall complications', 'incisional hernia rate, cosmetic results or pain', 'operating time or the overall rate of postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",193.0,0.191944,"In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups.
","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Klein', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Atakan Görkem', 'Initials': 'AG', 'LastName': 'Barutcu', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Kröll', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Kilian', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Pratschke', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Raakow', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Vivantes Klinikum Am Urban, Dieffenbachstrasse 1, 10967, Berlin, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Raakow', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. jonas.raakow@charite.de.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01911-1']
1301,32598234,Acute Effects of Weighted Baseball Throwing Programs on Shoulder Range of Motion.,"BACKGROUND


Baseball pitching injuries are increasing at an alarming rate. While weighted ball throwing programs may be effective at increasing pitching velocity, previous research has identified a 24% injury rate and a 3.3° increase in shoulder external rotation (ER) range of motion (ROM) after performing a 6-week program. However, previous research has not investigated, separately, the immediate effects of throwing underloaded and overloaded balls on ROM. The purpose of this study was to examine the acute effects of throwing differently weighted baseballs on shoulder ROM. By analyzing these differences, it may be possible to determine the specific weight range that may lead to the greatest increase in ROM and potential injury risk.
HYPOTHESIS


Throwing with weighted balls will result in an increase in shoulder ER ROM.
STUDY DESIGN


Randomized controlled trial.
LEVEL OF EVIDENCE


Level 2.
METHODS


A total of 16 male high school baseball pitchers agreed to participate in this study. The participants were (mean ± SD) 17.1 ± 1.0 years of age, 1.81 ± 0.09 m tall, and had a mass of 79.2 ± 11.1 kg. Each participant was tested on 3 different days, 1 week apart, with 3 different conditions in random order: (1) underload throwing, using regulation 5-oz baseballs and 4- and 2-oz balls; (2) overload throwing, using 5-, 6-, and 9-oz balls; and (3) extreme overload throwing, using 5-, 16-, and 32-oz balls. Each testing session began by measuring passive shoulder ROM (external rotation and internal rotation) using standard goniometric measurements. Participants then performed 3 throws with each weighted ball from 3 different positions (kneeling, rocker, and run-and-gun) for a total of 27 throws each test session. ROM measurements were repeated at the end of each test session. The effect of each throwing condition on ROM was compared from pre- to posttraining using a paired  t  test ( P  ≤ 0.05).
RESULTS


There was no significant difference in ER after throwing at underloaded weights. The overload condition showed a statistically significant increase of 3.3° in external rotation ( P  = 0.05). The extreme overload condition showed a statistically significant increase in ER of 8.4° ( P  < 0.001). There were no differences in internal rotation for any group.
CONCLUSION


A significant increase in shoulder ER was observed immediately after throwing overload weighted balls. This effect increased as the weights of the balls increased.
CLINICAL RELEVANCE


Throwing with overload weighted baseballs causes an immediate increase in shoulder ER ROM. It is unknown why these changes occur; however, the results may explain both the increase in velocity and injury rates previously observed from throwing weighted balls. The current study results may be used to develop more scientifically validated weighted ball programs. Heavier balls should be used with caution, and ROM should be monitored during implementation of these programs.",2020,The overload condition showed a statistically significant increase of 3.3° in external rotation ( P  = 0.05).,"['16 male high school baseball pitchers', 'The participants were (mean ± SD) 17.1 ± 1.0 years of age, 1.81 ± 0.09 m tall, and had a mass of 79.2 ± 11.1 kg']","['Weighted Baseball Throwing Programs', 'underload throwing, using regulation 5-oz baseballs and 4- and 2-oz balls; (2) overload throwing, using 5-, 6-, and 9-oz balls; and (3) extreme overload throwing, using 5-, 16-, and 32-oz balls']","['ROM', 'shoulder external rotation (ER) range of motion (ROM', 'weights of the balls increased', 'internal rotation', 'external rotation', 'Shoulder Range of Motion', 'ER', 'velocity and injury rates', 'shoulder ER ROM', 'shoulder ER', 'ROM measurements']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",16.0,0.0570077,The overload condition showed a statistically significant increase of 3.3° in external rotation ( P  = 0.05).,"[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Reinold', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Leonard C', 'Initials': 'LC', 'LastName': 'Macrina', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Fleisig', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Drogosz', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Andrews Sports Medicine and Orthopaedic Center, Birmingham, Alabama.'}]",Sports health,['10.1177/1941738120925728']
1302,32599257,"A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.","Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.",2020,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","['Patients with heart failure who are clinically eligible for an ICD are eligible for the study', 'Patients offered implantable Cardioverter-DEfibrillators', 'patients who have chronic progressive illness', '900 participants']","['implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation', 'shared DECision Support Intervention']",['decision quality (defined by knowledge and values-treatment concordance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0983498,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","[{'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Monica D', 'Initials': 'MD', 'LastName': 'Fitzgerald', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Tzou', 'Affiliation': 'Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kramer', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Varosy', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Cardiology Section, VA Eastern Colorado Health Care System, Aurora, CO.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Mid-America Heart Institute, Kansas City, MO.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Louisville, KY.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Brancato', 'Affiliation': 'Providence Heart Institute, Portland, OR.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}]",American heart journal,['10.1016/j.ahj.2020.04.010']
1303,32608055,Can radiographic patellofemoral osteoarthritis be diagnosed using clinical assessments?,"INTRODUCTION


The aim of this study was to determine whether participant characteristics and clinical assessments could identify radiographic osteoarthritis (OA) in individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA).
METHODS


Participant characteristics and clinical assessments were obtained from 179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial. Anteroposterior, lateral, and skyline X-rays were taken of the symptomatic knee. The presence of radiographic PFOA was defined as ""no or early PFOA"" (Kellgren and Lawrence [KL] grade ≤1 in the PF compartment) or ""definite PFOA"" (KL grade ≥2). Diagnostic test statistics were applied to ascertain which participant characteristics and clinical assessments could identify the presence of definite radiographic PFOA.
RESULTS


A total of 118 participants (66%) had definite radiographic PFOA. Univariate analysis identified that older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2  ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21) were associated with the presence of definite radiographic PFOA. Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
CONCLUSION


In individuals over 50 years of age with a clinical diagnosis of PFOA, higher BMI, longer pain duration, and fewer repeated single step-ups to pain onset increased the likelihood of radiographic PFOA. However, overall diagnostic accuracy was modest, suggesting that radiographic PFOA cannot be confidently identified using these tests.",2020,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
","['older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2  ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21', '118 participants (66%) had definite radiographic PFOA', '179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial', 'individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA']",[],"['BMI, pain duration, and repeated single step-ups to pain onset', 'radiographic osteoarthritis (OA', 'overall diagnostic accuracy', 'radiographic PFOA']","[{'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}]",118.0,0.0692962,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%.
","[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Tan', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Harvi F', 'Initials': 'HF', 'LastName': 'Hart', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Donnar', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Gearoid', 'Initials': 'G', 'LastName': 'Cleary', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Isobel C', 'Initials': 'IC', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Liam R', 'Initials': 'LR', 'LastName': 'Maclachlan', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Derham', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}]",Musculoskeletal care,['10.1002/msc.1490']
1304,32603336,Short-term effect of osteopathic manual techniques (OMT) on respiratory function in healthy individuals.,"BACKGROUND


Respiratory system diseases are some of the most common pathologies worldwide. Although osteopathic manual therapy (OMT) is used predominantly to treat other pathologies, certain OMT techniques have been shown to improve patients' respiratory function.
OBJECTIVES


The aim of this study was to assess the influence of osteopathic techniques on breathing.
METHODS


Tests were performed with the use of a spirometer and the results were expressed as Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Peak Expiratory Flow (PEF). Thirty healthy males and females between the age of 18 and 50 took part in the research. Fifteen individuals were randomly assigned to the experimental group and fifteen persons were assigned to the placebo group. The participants from the experimental group were treated with such osteopathic techniques aimed at the pulmonary system as the thoracic thrust (manipulations of vertebral joints and ribs), the sternal pump technique and stretching of the diaphragm. The placebo group was treated with soft tissue therapy (STT) techniques for the masseter muscle.
RESULTS


The described set of osteopathic techniques exerts an influence on PEF in healthy individuals; however, it does not affect FVC and FEV1.
CONCLUSION


Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.",2020,"Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.","['Fifteen individuals', 'Thirty healthy males and females between the age of 18 and 50 took part in the research', 'healthy individuals']","['osteopathic manual therapy (OMT', 'soft tissue therapy (STT) techniques', 'sternal pump technique and stretching of the diaphragm', 'osteopathic manual techniques (OMT', 'placebo']","['Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Peak Expiratory Flow (PEF', 'lung health', 'respiratory function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C3658309', 'cui_str': 'Soft Tissue Therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",30.0,0.044022,"Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.","[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Stępnik', 'Affiliation': 'Still Academy of Osteopathy, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kędra', 'Affiliation': 'Faculty of Physical Education and Health, Józef Pilsudski University of Physical Education in Warsaw, Biała Podlaska, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Czaprowski', 'Affiliation': 'Department of Health Sciences, Physiotherapy Unit, University of Medical Science, Poznań, Poland.'}]",PloS one,['10.1371/journal.pone.0235308']
1305,32603351,Low-intensity blood flow restriction calf muscle training leads to similar functional and structural adaptations than conventional low-load strength training: A randomized controlled trial.,"The purpose of this study was to investigate whether a six-week, twice weekly resistance training (4 sets at 30% 1-RM until failure) with practical blood flow restriction (BFR) using 7cm wide cuffs with a twist lock placed below the patella is superior to training without BFR (NoBFR) concerning muscle mass and strength gains in calf muscles. A two-group (BFR n = 12, mean age 27.33 (7.0) years, training experience 7.3 (7.0) years; NoBFR n = 9, mean age 28.9 (7.4) years, training experience 7.1 (6.6) years) randomized matched pair design based on initial 1-RM was used to assess the effects on structural and functional adaptations in healthy males (Perometer calf volume [CV], gastrocnemius muscle thickness using ultrasound [MT], 7-maximal hopping test for leg stiffness [LS], 1-RM smith machine calf raise [1-RM], and visual analogue scale as a measure of pain intensity [VAS]). The mean number of repetitions completed per training session across the intervention period was higher in the NoBFR group compared to the BFR group (70 (16) vs. 52 (9), p = 0.002). VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001). No group effects or time×group interactions were found for CV, MT, LS, and 1-RM. However, there were significant time effects for MT (BFR +0.07 cm; NoBFR +0.04; p = 0.008), and 1-RM (BFR +40 kg; NoBFR +34 kg; p<0.001). LS and CV remained unchanged through training. VAS in both groups were similar, and BFR and NoBFR were equally effective for increasing 1-RM and MT in trained males. However, BFR was more time efficient, due to lesser repetition per training session.",2020,VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001).,"['A two-group (BFR n = 12, mean age 27.33 (7.0) years, training experience 7.3 (7.0) years; NoBFR n = 9, mean age 28.9 (7.4) years, training experience 7.1 (6.6) years']","['practical blood flow restriction (BFR) using 7cm wide cuffs with a twist lock placed below the patella is superior to training without BFR (NoBFR', 'healthy males (Perometer calf volume [CV], gastrocnemius muscle thickness using ultrasound', 'conventional low-load strength training', 'Low-intensity blood flow restriction calf muscle training']","['CV, MT, LS, and 1-RM', 'VAS', 'LS and CV', '1-RM', '7-maximal hopping test for leg stiffness [LS], 1-RM smith machine calf raise [1-RM], and visual analogue scale as a measure of pain intensity [VAS', 'mean number of repetitions completed per training session']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0201696,VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gavanda', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Isenmann', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Schlöder', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Roth', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Freiwald', 'Affiliation': 'Department of Sport Science Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schiffer', 'Affiliation': 'Outpatient Clinic for Sports Traumatology and Public Health Consultation, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Geisler', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Behringer', 'Affiliation': 'Institute of Sports Sciences, Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0235377']
1306,32603357,Shallow-angle needle guide for ultrasound-guided internal jugular venous catheterization: A randomized controlled crossover simulation study (CONSORT).,"BACKGROUND


Needle guides for ultrasound-guided internal jugular venous catheterization facilitate successful cannulation. The ability of a needle guide to prevent a posterior vein wall injury which may secondarily induce lethal complications, is unknown. Previous studies showed that a shallow angle of approach may reduce the incidence of posterior wall injuries. We developed a novel needle guide with a shallow angle of approach for ultrasound-guided venous catheterization and examined whether this needle guide reduces the incidence of posterior wall injuries compared to a conventional needle guide and free-hand placement in a simulated vein.
METHODS


This study was a randomized crossover-controlled trial. The primary outcome was the rate of posterior vein wall injuries. Participants had a didactic lecture about three ultrasound-guided techniques using the short-axis out-of-plane approach, including free-hand (P-free), a commercial needle guide (P-com), and a novel needle guide (P-sha). The view inside a simulated vein was recorded during venipuncture.
RESULTS


Thirty-five residents participated in this study. Posterior vein wall injuries occurred in 66% using P-free, 60% using P-com, and 0% using P-sha (p< 0.01). There was no significant difference in the incidence of posterior vein wall injuries between P-free and P-com.
CONCLUSIONS


Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.",2020,"CONCLUSIONS


Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.",['Thirty-five residents participated in this study'],['Shallow-angle needle guide for ultrasound-guided internal jugular venous catheterization'],"['rate of posterior vein wall injuries', 'incidence of posterior vein wall injuries', 'Posterior vein wall injuries', 'rate of posterior vein injuries']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0181951', 'cui_str': 'Needle guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0226509', 'cui_str': 'Structure of wall of vein'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340770', 'cui_str': 'Injury of vein'}]",35.0,0.0425578,"CONCLUSIONS


Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.","[{'ForeName': 'Kunitaro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Joho', 'Initials': 'J', 'LastName': 'Tokumine', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Alan Kawarai', 'Initials': 'AK', 'LastName': 'Lefor', 'Affiliation': 'Department of Surgery, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yorozu', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0235519']
1307,32603380,Treatment outcomes of Pumani bubble-CPAP versus oxygen therapy among preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial.,"BACKGROUND


Respiratory distress syndrome (RDS) is the most common respiratory disease in premature babies and the major cause of morbidity and mortality among preterm babies. Effective treatment of these babies requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in low and middle income countries. A cheaper, simpler and more accessible treatment for preterms with RDS called bubble-continuous positive airway pressure (bCPAP) has been reported to be effective in treating RDS in preterm babies with varying levels of effectiveness ranging from 42% to 85%. We aimed to implement and determine the efficacy of bCPAP and its immediate outcomes as compared to oxygen therapy in preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania.
METHOD


A randomized control trial, conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria. The primary outcome was survival while the secondary outcomes were treatment duration, duration of hospital stay and treatment complications.
RESULTS


A total of 824 babies were admitted in the neonatal care unit during the study period. Of these, 187 babies were preterm and 48 babies were recruited and randomized (25 bCPAP vs 23 oxygen). The overall survival to discharge for all eligible participants (n = 48) was 58.2% compared to those who adhered to treatment protocol (n = 45, 62.2%). Babies in the bCPAP group had higher survival (17/22; 77.3%) as compared to their counterparts in the oxygen therapy group (11/23; 47.8%). Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy. The median duration of treatment for babies in the oxygen therapy group was 2 (Range 0-16) days compared to 2 (Range 0-5) days in the bCPAP group. The median duration of hospital stay for babies receiving bCPAP was 14 (range 7-43) days. Nasal bleeding was commonly observed among babies in the bCPAP group as compared to those in the oxygen therapy group.
CONCLUSION


This study revealed that treatment with bCPAP had a 30% clinical improvement in survival to discharge. Our findings highlight the role of bCPAP in reducing neonatal mortality in resource limited settings but further adequately powered studies in this or similar settings are required.",2020,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","['conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania', '187 babies were preterm and 48 babies', 'Respiratory distress syndrome (RDS', 'preterm babies', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial', '824 babies were admitted in the neonatal care unit during the study period']","['oxygen therapy', 'bCPAP', 'Pumani bubble-CPAP versus oxygen therapy']","['Nasal bleeding', 'median duration of hospital stay', 'risk of death', 'survival to discharge', 'median duration of treatment for babies', 'treatment duration, duration of hospital stay and treatment complications', 'survival', 'neonatal mortality', 'overall survival to discharge', 'higher survival']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}]",824.0,0.182245,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","[{'ForeName': 'Annette Baine', 'Initials': 'AB', 'LastName': 'Mwatha', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mahande', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Raimos', 'Initials': 'R', 'LastName': 'Olomi', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Philemon', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}]",PloS one,['10.1371/journal.pone.0235031']
1308,32684162,Correction to: Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study).,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"[""Alzheimer's disease""]",['novel GLP-1 analogue liraglutide'],[],"[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]",[],,0.0782946,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Grazia Daniela', 'Initials': 'GD', 'LastName': 'Femminella', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangou', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Busza', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Holmes', 'Affiliation': 'Southern Health NHS Foundation Trust, Havant, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ritchie', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lawrence', 'Affiliation': ""SW London and St George's Mental Health Trust, London, UK.""}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'McFarlane', 'Affiliation': 'Southern Health NHS Foundation Trust, Havant, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tadros', 'Affiliation': 'Aston Medical school, Aston University, Birmingham, UK.'}, {'ForeName': 'Basil H', 'Initials': 'BH', 'LastName': 'Ridha', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bannister', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Walker', 'Affiliation': 'University College London and Essex Partnership University NHS Foundation Trust, Runwell, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Archer', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coulthard', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Underwood', 'Affiliation': 'Cambridgeshire and Peterborough NHS Foundation Trust, Peterborough, UK.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Prasanna', 'Affiliation': 'Black Country Partnership NHS Foundation Trust, West Bromwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Koranteng', 'Affiliation': 'Northamptonshire Healthcare NHS Foundation Trust, Kettering, UK.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Karim', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Kehinde', 'Initials': 'K', 'LastName': 'Junaid', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'McGuinness', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nilforooshan', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, Leatherhead, UK.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Macharouthu', 'Affiliation': 'NHS Ayrshire and Arran, Crosshouse, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Donaldson', 'Affiliation': 'NHS Lanarkshire, Glasgow, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thacker', 'Affiliation': 'Derbyshire Healthcare NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Bradford District Care NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Naghma', 'Initials': 'N', 'LastName': 'Malik', 'Affiliation': '5 Boroughs Partnership NHS Foundation Trust, Warrington, UK.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Mate', 'Affiliation': 'Cornwall Partnership NHS Foundation Trust, Redruth, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Knight', 'Affiliation': 'Somerset Partnership NHS Foundation Trust, Bridgwater, UK.'}, {'ForeName': 'Sajeev', 'Initials': 'S', 'LastName': 'Kshemendran', 'Affiliation': 'South Staffordshire and Shropshire Healthcare NHS Foundation Trust, Stafford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Harrison', 'Affiliation': 'Alzheimer Center VUmc Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hölscher', 'Affiliation': 'Research Department, Henan University of Chinese Medicine, Zhengzhou, China.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Brooks', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Anthony Peter', 'Initials': 'AP', 'LastName': 'Passmore', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Edison', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK. paul.edison@imperial.ac.uk.'}]",Trials,['10.1186/s13063-020-04608-4']
1309,32609859,Effectiveness of Best Possible Self and Gratitude Writing Intervention on Mental Health Among Parents of Troubled Children.,"The current study was conducted to determine if journaling focused on best possible self and gratitude could improve physiological and mental health outcomes in a sample of affected parents who have teenagers or adult children with emotional and/or behavioral problems. A quasi-experimental, pretest/posttest design was used with blood pressure measure and saliva collection at baseline, after a first journal entry, and after a 6-week journaling intervention. Among 42 parents who completed the pretest, 37 (88.1%) completed the 6-week guided journal and posttest. Findings of paired t tests indicated a statistically significant decrease in stress level (p < 0.001), anxiety (p < 0.001), somatic symptoms (p = 0.001), and depression (p = 0.01), as well as increased gratitude (p = 0.012) among participants. Repeated measures analysis of variance indicated the journaling intervention showed a statistically significant reduction in systolic blood pressure (p = 0.016), but not diastolic blood pressure, or cortisol level at the three testing times. [Journal of Psychosocial Nursing and Mental Health Services, 58(9), 31-39.].",2020,"Findings of paired t tests indicated a statistically significant decrease in stress level (p < 0.001), anxiety (p < 0.001), somatic symptoms (p = 0.001), and depression (p = 0.01), as well as increased gratitude (p = 0.012) among participants.","['Parents of Troubled Children', 'a sample of affected parents who have teenagers or adult children with emotional and/or behavioral problems', '42 parents who completed the pretest, 37 (88.1%) completed the 6-week guided journal and posttest']",['Best Possible Self and Gratitude Writing Intervention'],"['blood pressure measure and saliva collection', 'anxiety', 'stress level', 'somatic symptoms', 'depression', 'systolic blood pressure', 'diastolic blood pressure, or cortisol level', 'physiological and mental health outcomes', 'Mental Health']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",42.0,0.0249079,"Findings of paired t tests indicated a statistically significant decrease in stress level (p < 0.001), anxiety (p < 0.001), somatic symptoms (p = 0.001), and depression (p = 0.01), as well as increased gratitude (p = 0.012) among participants.","[{'ForeName': 'YeounSoo', 'Initials': 'Y', 'LastName': 'Kim-Godwin', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200624-07']
1310,32647051,Effect of High-Intensity Interval Training on Glycemic Control in Adults With Type 1 Diabetes and Overweight or Obesity: A Randomized Controlled Trial With Partial Crossover.,"OBJECTIVE


To study the effect of 12 weeks of high-intensity interval training (HIIT) on glycemic control in adults with type 1 diabetes and overweight or obesity.
RESEARCH DESIGN AND METHODS


Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2  and HbA 1c  ≥7.5% were randomized to 12 weeks of either HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control. In a partial crossover design, the control group subsequently performed the 12-week HIIT intervention. The primary end point was the change in HbA 1c  from baseline to 12 weeks. Glycemic and cardiometabolic outcomes were measured at 0, 12, and 24 weeks.
RESULTS


Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 . HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08). In participants who undertook at least 50% of the prescribed HIIT intervention, the HbA 1c  reduction was significantly greater than control (HIIT -0.64 ± 0.64% [ n  = 9], control -0.14 ± 0.48% [ n  = 15],  P  = 0.04). There were no differences in insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition between groups.
CONCLUSIONS


Overall, there was no significant reduction in HbA 1c  with a 12-week HIIT intervention in adults with type 1 diabetes. However, glycemic control may improve for people who undertake HIIT with greater adherence.",2020,"HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08).","['Adults With Type 1 Diabetes and Overweight or Obesity', 'adults with type 1 diabetes', 'Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2  and HbA 1c  ≥7.5', 'adults with type 1 diabetes and overweight or obesity', 'Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 ']","['HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control', 'high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['change in HbA 1c', 'Glycemic and cardiometabolic outcomes', 'HbA 1c  reduction', 'insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition', 'HbA 1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517683', 'cui_str': '3.1'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",30.0,0.0504138,"HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08).","[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'McGill', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Overland', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Callum J', 'Initials': 'CJ', 'LastName': 'Baker', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Martinez-Huenchullan', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jencia', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Flack', 'Affiliation': 'Diabetes Centre, Bankstown-Lidcombe Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia stephen.twigg@sydney.edu.au.'}]",Diabetes care,['10.2337/dc20-0342']
1311,32647053,Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial.,,2020,,['Type 2 Diabetes Patients With and'],['Liraglutide'],['Cardiovascular Outcomes'],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0347564,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC matthew.crowley@duke.edu.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Thomas Jon', 'Initials': 'TJ', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",Diabetes care,['10.2337/dc20-0437']
1312,32644875,Effects of Estradiol Dose and Serum Estradiol Levels on Metabolic Measures in Early and Late Postmenopausal Women in the REPLENISH Trial.,"Background:  To identify the association of estradiol (E2) dose and serum E2 levels with metabolic measures in early (<6 years) compared with late (≥10 years) postmenopausal women from the REPLENISH trial.  Material and Methods:  This is a  post hoc  analysis of a multicenter randomized clinical trial in the United States. Four doses of TX-001HR, an oral combination of E2 and progesterone (P4), and placebo were tested. This analysis included a total of 1,216 early and 297 late postmenopausal women. Linear mixed-effects models tested the association of E2 dose and serum E2 levels with changes in metabolic parameters; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and glucose (GLUC) levels from six visits over 12 months, adjusted for the serum P4 level.  Results:  A higher E2 dose was significantly associated with lower TC ( p  = 0.02) and LDL-C ( p  = 0.002) and higher HDL-C ( p  = 0.04) levels in early, but not late, postmenopause. With longer time since menopause, the inverse association of E2 dose with TC and LDL-C and positive association with HDL-C were attenuated (interaction  p  < 0.05). Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause.  Conclusion:  E2 dose differentially affects metabolic measures among early compared with late postmenopausal women. No significant main effect of the serum P4 level was found. As the metabolic parameters studied are risk factors for cardiovascular events, these results support the timing hypothesis of E2 therapy and its cardiovascular benefits.",2020,"Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause.  ","['early (<6 years) compared with late (≥10 years', 'Early and Late Postmenopausal Women', 'postmenopausal women', 'late postmenopausal women', '1,216 early and 297 late postmenopausal women']","['Estradiol Dose and Serum Estradiol Levels', 'TX-001HR, an oral combination of E2 and progesterone (P4), and placebo']","['fasting blood GLUC', 'serum P4 level', 'association of estradiol (E2) dose and serum E2 levels with metabolic measures', 'LDL-C', 'Higher serum E2 levels', 'metabolic measures', 'metabolic parameters; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and glucose (GLUC) levels']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",1216.0,0.0619169,"Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause.  ","[{'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, Florida, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, Florida, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2019.8238']
1313,32656994,A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study.,"OBJECTIVE


Intensive behavioral obesity treatments face scalability challenges, but evidence is lacking about which treatment components could be cut back without reducing weight loss. The Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (Opt-IN) study applied the Multiphase Optimization Strategy to develop an entirely remotely delivered, technology-supported weight-loss package to maximize the amount of weight loss attainable for ≤$500.
METHODS


Six-month weight loss was examined among adults (N = 562) with BMI ≥ 25 who were randomly assigned to conditions in a factorial experiment crossing five dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training).
RESULTS


About 84.3% of participants completed the final assessment. The treatment package yielding maximum weight loss for ≤$500 included 12 coaching calls, buddy training, and primary care provider progress reports; produced average weight loss of 6.1 kg, with 57.1% losing ≥5% and 51.8% losing ≥7%; and cost $427 per person. The most expensive candidate-treatment component (24 vs. 12 coaching calls) was screened out of the optimized treatment package because it did not increase weight loss.
CONCLUSIONS


Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.",2020,"Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.","['Obesity', 'Six-month weight loss was examined among adults (N\u2009=\u2009562) with BMI\u2009≥\u200925 who']","['dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training']","['average weight loss', 'weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",562.0,0.0217213,"Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.","[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Angela F', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Sara H', 'Initials': 'SH', 'LastName': 'Marchese', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Stump', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'H Gene', 'Initials': 'HG', 'LastName': 'McFadden', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Siddique', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'The Methodology Center, Pennsylvania State University, University Park, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22915']
1314,32603613,Randomised comparison of 1.1 GBq and 3.7 GBq radioiodine to ablate the thyroid in the treatment of low-risk thyroid cancer: a 13-year follow-up.,"Purpose:  The optimal activity of radioiodine (I-131) administered for ablation therapy in papillary and follicular thyroid cancer after thyroidectomy remains unknown in a long-term (> 10 year) follow-up. Some, shorter follow-up studies suggest that activities 1.1 GBq and 3.7 GBq are equally effective. We evaluated the long-term outcomes after radioiodine treatment to extend current knowledge about the optimal ablative dose of I-131. Methods:  One hundred and sixty consecutive adult patients (129 females, 31 males; mean age 46 ± 14 y, range 18-89 y) diagnosed with histologically confirmed differentiated thyroid cancer, were randomised in a prospective, phase III, open-label, single-centre study, to receive either 1.1 GBq or 3.7 GBq of I-131 after thyroidectomy. At randomisation, patients were stratified according to the histologically verified cervical lymph node status and were prepared for ablation using thyroid hormone withdrawal. No uptake in the whole-body scan with I-131 and serum thyroglobulin concentration less than 1 ng/mL at 4-8 months after treatment was considered successful ablation. Results:  Median follow-up time was 13.0 years (mean 11.0 ± 4.8 y; range 0.3-17.1 y). Altogether 81 patients received 1.1 GBq with successful ablation in 45 (56%) patients. In the original study, thirty-six patients (44%) needed one or more extra administrations to replete the ablation. Of these, 4 (8.9%) and 5 (14%) patients relapsed during the follow-up, respectively. Of the 79 patients treated with 3.7 GBq 45 (57%) had successful ablation after one administration of radioiodine and 34 (43%) needed several treatments. Of these, 2 (4.4%) and 9 (26.5%) patients relapsed, respectively. The groups did not differ in the proportion of patients relapsing ( p  = .591). Conclusion:  During follow-up of median 13 years, 3.7 GBq is not superior to 1.1 GBq in the radioiodine treatment after thyroidectomy in papillary and follicular thyroid cancer.",2020,"During follow-up of median 13 years, 3.7 GBq is not superior to 1.1 GBq in the radioiodine treatment after thyroidectomy in papillary and follicular thyroid cancer.","['low-risk thyroid cancer', 'One hundred and sixty consecutive adult patients (129 females, 31 males; mean age 46\u2009±\u200914\u2009y, range 18-89\u2009y) diagnosed with histologically confirmed differentiated thyroid cancer']","['1.1 GBq and 3.7 GBq radioiodine', 'radioiodine (I-131) administered for ablation therapy', 'radioiodine']","['serum thyroglobulin concentration', 'proportion of patients relapsing', 'successful ablation']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}]","[{'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C1688582', 'cui_str': 'GBq'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}, {'cui': 'C0303029', 'cui_str': 'iodine I-131'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",160.0,0.027105,"During follow-up of median 13 years, 3.7 GBq is not superior to 1.1 GBq in the radioiodine treatment after thyroidectomy in papillary and follicular thyroid cancer.","[{'ForeName': 'Veera', 'Initials': 'V', 'LastName': 'Ahtiainen', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Vaalavirta', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Tenhunen', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mäenpää', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1785003']
1315,32609756,Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.,"BACKGROUND


Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design.
METHODS AND FINDINGS


Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan-Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15-0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period.
CONCLUSIONS


ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02776254.",2020,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"['At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC', 'Zambian urban adherence club (AC', '489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female', 'HIV-infected adults in Zambia', '10 clinics were randomized to intervention (5 clinics) or control (5 clinics']",['differentiated service delivery (DSD'],"['rate of late drug pickup', 'median time since ART initiation', 'Median MPR', 'unadjusted Kaplan-Meier survival curves', 'time to first late drug pickup', 'median CD4 count', 'Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",10.0,0.184599,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bolton-Moore', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Izukanji', 'Initials': 'I', 'LastName': 'Sikazwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mpande', 'Initials': 'M', 'LastName': 'Mukumbwa-Mwenechanya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Efronson', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chanda', 'Initials': 'C', 'LastName': 'Mwamba', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Somwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kalunkumya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwansa', 'Initials': 'M', 'LastName': 'Lumpa', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Pry', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Wilbroad', 'Initials': 'W', 'LastName': 'Mutale', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': 'University of California, Berkeley, Berkeley, California, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Topp', 'Affiliation': 'James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Geng', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Holmes', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003116']
1316,32610573,The Performance Effect of Scheduled Carbohydrate and Caffeine Intake during Simulated Team Sport Match-Play.,"The aim of the current investigation was to identify the effects of scheduled carbohydrate (CHO) and caffeine (CAF) supplementation on simulated team sport match-play performance. Ten male hurling players completed three hurling match-play simulation protocols (HSP) performed 7 days apart in a double-blind, randomized design. Supplementation included CHO, CHO + CAF, and placebo (PLA). In a randomized order, participants ingested either a 6% CHO solution, a PLA solution of similar taste, or a combined intake of 6% CHO solution + 200 mg CAF capsule. At specific time points (Pre-0 min; half time (HT)-30 min; full time (FT)-60 min), participants completed a repeated sprint protocol (RAST; 12 × 20 m). Physiological [% maximal oxygen uptake (%VO 2max ), % mean oxygen uptake (%VO 2mean ), % maximal heart rate (%HR max ), % mean heart rate (%HR mean ), respiratory exchange ratio (RER), and blood lactate (BLa)] and performance [(best sprint time (RSA best ), mean sprint time (RSA mean ), and rate of perceived exertion (RPE)] variables were monitored throughout each simulation. Non-significant differences were observed between supplement trials (CHO, CHO + CAF, and PLA) for BLa (η 2  = 0.001,  small ), %VO 2max  (η 2  = 0.001,  small ), %VO 2mean  (η 2  = 0.004,  small ), %HR max  (η 2  = 0.007,  small ), %HR mean  (η 2  = 0.018,  small ), RER (η 2  = 0.007,  small ), RPE (η 2  = 0.007,  small ), and RSA best  (η 2  = 0.050,  small ). RSA mean  performance significantly improved in CHO + CAF trials compared to PLA, with sprint times significantly improved from Pre to FT also (η 2  = 0.135,  medium ). A significant difference was observed in BLa between time points (Pre, HT, and FT) (η 2  = 0.884,  large ) in % HRmax (η 2  = 0.202,  medium ), %HR mean  (η 2  = 0.477,  large ), and RER (η 2  = 0.554,  large ) across halves and in RPE across time points (η 2  = 0.670,  large ). Our data provide novel data regarding the effects of CHO and CAF supplementation on team sport performance, with co-ingestion of CHO + CAF reducing the decrement in repeated sprint performance compared to PLA.",2020,"RSA mean  performance significantly improved in CHO + CAF trials compared to PLA, with sprint times significantly improved from Pre to FT also (η 2  = 0.135,  medium ).",['Ten male hurling players completed three'],"['scheduled carbohydrate (CHO) and caffeine (CAF) supplementation', 'Scheduled Carbohydrate and Caffeine Intake', 'CHO and CAF supplementation', '6% CHO solution, a PLA solution of similar taste, or a combined intake of 6% CHO solution + 200 mg CAF capsule', 'hurling match-play simulation protocols (HSP']","[' mean oxygen uptake', 'CHO, CHO + CAF, and placebo (PLA', 'maximal heart rate', 'RER', 'repeated sprint performance', 'HR mean  ', 'supplement trials (CHO, CHO + CAF, and PLA) for BLa', 'BLa between time points (Pre, HT, and FT', 'RSA mean  performance', 'Physiological [% maximal oxygen uptake', 'mean heart rate (%HR mean ), respiratory exchange ratio (RER), and blood lactate (BLa)] and performance [(best sprint time (RSA best ), mean sprint time (RSA mean ), and rate of perceived exertion (RPE)] variables']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0574531', 'cui_str': 'Blackfoot language'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",10.0,0.234824,"RSA mean  performance significantly improved in CHO + CAF trials compared to PLA, with sprint times significantly improved from Pre to FT also (η 2  = 0.135,  medium ).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keane', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Aidan', 'Initials': 'A', 'LastName': 'Shovlin', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Devenney', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Limerick Institute of Technology, Thurles Campus, V94 EC5T Limerick, Ireland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Coratella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Collins', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Shortall', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}]",Nutrients,['10.3390/nu12071926']
1317,32610647,Intermittent Hypoxic Exposure with High Dose of Arginine Impact on Circulating Mediators of Tissue Regeneration.,"Intermittent exposure to hypoxia (IHE) increases production of reactive oxygen and nitrogen species which, as signalling molecules, participate in tissue injury-repair-regeneration cascade. The process is also stimulated by arginine whose bioavailability is a limiting factor for NO synthesis. The effects of IHE in combination with arginine (Arg) intake on myogenesis and angiogenesis mediators were examined in a randomized and placebo-controlled trial. Blood samples were collected from 38 elite athletes on the 1st, 7th and 14th days during the training camp. The oral doses of arginine (2 × 6 g/day) and/or IHE using hypoxicator GO2Altitude (IHE and Arg/IHE) were applied. Serum NO and H 2 O 2  concentrations increased significantly and were related to muscle damage (CK activity >900 IU/mL) in IHE and Arg/IHE compared to placebo. The changes in NO and H 2 O 2  elevated the levels of circulating growth factors such as HGF, IHG-1, PDGF BB , BDNF, VEGF and EPO. Modification of the lipid profile, especially reduced non-HDL, was an additional beneficial effect of hypoxic exposure with arginine intake. Intermittent hypoxic exposure combined with high-dose arginine intake was demonstrated to affect circulating mediators of injury-repair-regeneration. Therefore, a combination of IHE and arginine seems to be a potential therapeutic and non-pharmacological method to modulate the myogenesis and angiogenesis in elite athletes.",2020,2 O 2  concentrations increased significantly and were related to muscle damage (CK activity >900 IU/mL) in IHE and Arg/IHE compared to placebo.,"['elite athletes', '38 elite athletes on the 1st, 7th and 14th days during the training camp']","['Intermittent exposure to hypoxia (IHE', 'arginine', 'Intermittent hypoxic exposure combined with high-dose arginine intake', 'IHE using hypoxicator GO2Altitude (IHE and Arg/IHE', 'IHE', 'arginine (Arg) intake', 'placebo']","['circulating mediators of injury-repair-regeneration', 'Circulating Mediators of Tissue Regeneration', 'Serum', 'levels of circulating growth factors such as HGF, IHG-1, PDGF BB , BDNF, VEGF and EPO', 'muscle damage (CK activity', 'myogenesis and angiogenesis mediators']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0596997', 'cui_str': 'Myogenesis'}]",38.0,0.025484,2 O 2  concentrations increased significantly and were related to muscle damage (CK activity >900 IU/mL) in IHE and Arg/IHE compared to placebo.,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Zembron-Lacny', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Gramacki', 'Affiliation': 'Faculty of Computer, Electrical and Control Engineering. Institute of Control and Computation Engineering University of Zielona Gora, 65-417 Zielona Gora Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Wawrzyniak-Gramacka', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tylutka', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Hertmanowska', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kasperska', 'Affiliation': 'Department of Physiology, University School of Physical Education in Poznan, 61-871 Poznan, Poland.'}, {'ForeName': 'Miłosz', 'Initials': 'M', 'LastName': 'Czuba', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}]",Nutrients,['10.3390/nu12071933']
1318,32610864,"A Prospective, Randomized, Interventional Study of Oral Iron Supplementation Comparing Daily Dose with Alternate Day Regimen Using Hepcidin as a Biomarker in Iron Deficiency Anemia.","Aim


To assess effect of daily vis-a-vis alternate day oral iron therapy in terms of hemoglobin, reticulocyte hemoglobin equivalent (RET-He) and GI side effects using hepcidin as a biomarker.
Methods


A hospital based randomized interventional two-arm analytical study was done among patients of IDA (20 in each group). The study population was divided into two groups by randomisation. Group 1 received oral iron supplements on alternate day and Group 2 received iron supplements daily. Hemoglobin, RET-He, Serum ferritin and Hepcidin level were assessed.
Results


On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group. On day 3, the rise in hepcidin was significant from base line in both the groups but the mean change in hepcidin was more in daily therapy group. RET-He began increasing on day 2nd in both the groups. In alternate day therapy group, the rise in RET-He was significant from base line from the day 2nd onwards while the rise in RET-He in daily therapy group was not significant even on day 3. In alternate day iron therapy group, the mean increase in hemoglobin on day 21th (1.58 ±0.53 gm/dl) was significantly more than mean increase among daily therapy (0.41 ± 0.25 gm/dl, P <0.05).
Conclusion


Alternate day single tablet dosing schedule of oral iron therapy (60mg of elemental iron, ferrous sulfate) was more effective and better tolerated (gastrointestinal side effects) compared to daily supplementation in IDA.",2020,"On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group.",['patients of IDA (20 in each group'],"['daily vis-a-vis alternate day oral iron therapy', 'Oral Iron Supplementation', 'oral iron therapy (60mg of elemental iron, ferrous sulfate', 'oral iron supplements']","['Hemoglobin, RET-He, Serum ferritin and Hepcidin level', 'mean increase in hemoglobin', 'effective and better tolerated (gastrointestinal side effects', 'hemoglobin, reticulocyte hemoglobin equivalent (RET-He) and GI side effects', 'rise in Hepcidin', 'rise in RET-He', 'rise in hepcidin', 'mean change in hepcidin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1571809', 'cui_str': 'Visceral manipulation'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4049225', 'cui_str': 'Reticulocyte haemoglobin equivalent'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0337129,"On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group.","[{'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Senior Professor, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Bhawani Shankar', 'Initials': 'BS', 'LastName': 'Sharma', 'Affiliation': 'Resident, Department of Medicine, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Senior Professor, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Assistant Professor, Department of Pathology, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Laxmi Kant', 'Initials': 'LK', 'LastName': 'Goyal', 'Affiliation': 'Assistant Professor, Geriatric Medicine, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Shaurya', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Senior Resident, Department of Medicine, SMS Medical College, Jaipur, Rajasthan.'}]",The Journal of the Association of Physicians of India,[]
1319,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE


This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy.
MATERIALS AND METHODS


This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment.
RESULTS


All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response.
CONCLUSIONS


Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609']
1320,32618249,"Cost-Effectiveness of Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine for Malaria Prevention in Southern Province, Zambia: Results of a Community-Randomized Controlled Trial.","Community-wide administration of antimalarial drugs in therapeutic doses is a potential tool to prevent malaria infection and reduce the malaria parasite reservoir. To measure the effectiveness and cost of using the antimalarial drug combination dihydroartemisinin-piperaquine (DHAp) through different community-wide distribution strategies, Zambia's National Malaria Control Centre conducted a three-armed community-randomized controlled trial. The trial arms were as follows: 1) standard of care (SoC) malaria interventions, 2) SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA. Mass drug administration consisted of offering all eligible individuals DHAP, irrespective of a rapid diagnostic test (RDT) result. Focal mass drug administration consisted of offering DHAP to all eligible individuals who resided in a household where anyone tested positive by RDT. Results indicate that the costs of fMDA and MDA per person targeted and reached are similar (US$9.01 versus US$8.49 per person, respectively,  P  = 0.87), but that MDA was superior in all cost-effectiveness measures, including cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted. Subsequent costing of the MDA intervention in a non-trial, operational setting yielded significantly lower costs per person reached (US$2.90). Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations. A sensitivity analysis using costs from operational deployment and trial effectiveness yielded improved cost-effectiveness estimates. Mass drug administration may be a cost-effective intervention in the Zambian context and can help reduce the parasite reservoir substantially. Mass drug administration was more cost-effective in relatively higher transmission settings. In all scenarios examined, the cost-effectiveness of MDA was superior to that of fMDA.",2020,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","['Southern Province, Zambia', 'eligible individuals who resided in a household where anyone tested positive by RDT']","['SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA', 'MDA intervention', 'Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine', 'antimalarial drug combination dihydroartemisinin-piperaquine (DHAp']","['costs of fMDA and MDA', 'cost-effectiveness of MDA', 'cost-effectiveness estimates', 'cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0012324', 'cui_str': 'Dihydroxyacetone 3-Phosphate'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.139118,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","[{'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Callie', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Larson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0661']
1321,32618251,"Treatment Coverage Estimation for Mass Drug Administration for Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia.","Mass drug administration (MDA) is currently being considered as an intervention in low-transmission areas to complement existing malaria control and elimination efforts. The effectiveness of any MDA strategy is dependent on achieving high epidemiologic coverage and participant adherence rates. A community-randomized controlled trial was conducted from November 2014 to March 2016 to evaluate the impact of four rounds of MDA or focal MDA (fMDA)-where treatment was given to all eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000). This study examined epidemiologic coverage and program reach using capture-recapture and satellite enumeration methods to estimate the degree to which the trial reached targeted individuals. Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment. When the maximum number of visited households across all campaign rounds was used as the numerator, program reach for at least one visit would have been 86.4% (95% CI: 80.8-92.0) in MDA and 83.5% (95% CI: 78.0-89.1) in fMDA trial arms. As per the protocol, the trial provided dihydroartemisinin-piperaquine treatment to an average of 58.8% and 13.3% of the estimated population based on capture-recapture in MDA and fMDA, respectively, across the four rounds.",2020,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","['Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia', 'eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000']",['MDA or focal MDA (fMDA)-where treatment'],[],"[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.101887,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0665']
1322,32618265,"Moving from Malaria Burden Reduction toward Elimination: An Evaluation of Mass Drug Administration in Southern Province, Zambia.","From December 2014 to February 2016, a cluster randomized controlled trial was carried out in 60 health facility catchment areas along Lake Kariba in Zambia's Southern Province. The trial sought to evaluate the impact of four rounds of a mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP at the household level compared with a control population that received the standard of care. This study was the first randomized controlled trial with DHAP for MDA in sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University. This article serves as an introduction to a collection of articles designed to explore different aspects of the intervention. By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.",2020,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","['sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University', ""60 health facility catchment areas along Lake Kariba in Zambia's Southern Province"", 'Southern Province, Zambia']","['Elimination', 'DHAP', 'mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP']",[],"[{'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",[],,0.0505108,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Maya S', 'Initials': 'MS', 'LastName': 'Fraser', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Manuel T', 'Initials': 'MT', 'LastName': 'Lewis', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0669']
1323,32618627,Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial.,"BACKGROUND


Perioperative pediatric anxiety is common and can have a negative psychological impact on children undergoing surgery and anesthesia. Studies have shown an incidence of anxiety at induction of up to 50%. Audiovisual distraction, including virtual reality (VR), is a noninvasive, nonpharmacological modality that may reduce perioperative anxiety. The goal of this study was to determine whether immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA) in pediatric patients reduced preoperative anxiety.
METHODS


In this randomized-controlled, parallel-group study, 71 children 5-12 years of age scheduled for elective surgery with GA were randomly allocated to a VR group or a non-VR (No VR) control group. VR group patients underwent audiovisual distraction with a VR headset during induction in the operating room, whereas the control group received no audiovisual distraction. The primary outcome was the Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety: in the preoperative holding area before randomization, on entering the operating room, and during induction of GA. The primary outcome was analyzed using univariate analysis and a linear mixed-effects model. Secondary outcomes included postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction.
RESULTS


Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female. Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients). No patients received preoperative anxiolytic medication. Baseline mYPAS scores were not different between the groups, with scores of 28.3 (23.3-28.3) (median [interquartile range {IQR}]) in both. The change in mYPAS scores from baseline to time of induction was significantly lower in the VR group versus control group (0.0 [0.0-5.0] vs 13.3 [5.0-26.7]; P< .0001). In the mixed-effects model, the VR group had an estimated 6.0-point lower mYPAS score (95% confidence interval [CI], 0.7-11.3; P= .03) at room entry than the No VR group, and 14.5-point lower score (95% CI, 9.3-19.8; P< .0001) at induction versus control. Randomization to VR did not alter parental anxiety (0 [-2 to 2]), pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 [-8 to 2]) (difference in medians [95% CI]).
CONCLUSIONS


This study demonstrates a reduction in pediatric preoperative anxiety with the use of VR. Preoperative VR may be an effective noninvasive modality for anxiolysis during induction of anesthesia in children.",2020,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"['children', 'Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female', 'children undergoing surgery and anesthesia', '71 children 5-12 years of age scheduled for elective surgery with GA', 'pediatric patients reduced preoperative anxiety']","['Anesthesia With Virtual Reality and Perioperative Anxiolysis', 'immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA', 'Audiovisual distraction, including virtual reality (VR', 'audiovisual distraction with a VR headset', 'preoperative anxiolytic medication', 'Pediatric Distraction', 'control group received no audiovisual distraction', 'VR group or a non-VR (No VR) control group']","['Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety', 'pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 ', 'postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction', 'mYPAS score', 'pediatric preoperative anxiety', 'parental anxiety', 'perioperative anxiety', 'Baseline mYPAS scores', 'mYPAS scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",71.0,0.0798988,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Jung', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Libaw', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Whitlock', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Feiner', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Jina L', 'Initials': 'JL', 'LastName': 'Sinskey', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005004']
1324,32618692,Prospective Randomized Controlled Trial of Video- Versus Recall-Assisted Reflection in Simulation-Based Teaching on Acquisition and Retention of Airway Skills Among Trainees Intubating Critically Ill Patients.,"OBJECTIVES


Conventionally, simulation-based teaching involves reflection on recalled events (recall-assisted reflection). Instead of recall, video-assisted reflection may reduce recall bias and improve skills retention by contributing to visual memory. Here, we test the hypothesis that when compared with recall, video-assisted reflection results in higher acquisition and retention of skills involved in airway management among junior critical care doctors.
DESIGN


Randomized control trial. Participants were randomized 1:1 to video-assisted reflection or recall-assisted reflection group.
SETTING


University-affiliated tertiary care center.
SUBJECTS


Junior critical care doctors.
INTERVENTION


Video-assisted reflection.
MEASUREMENTS AND MAIN RESULTS


All participants underwent simulation-based teaching of technical and nontechnical airway skills involved in managing a critically ill patient. These skills were assessed before, post-workshop, and in the following fourth week, by two independent blinded assessors using a validated scoring tool. Quality of debrief was assessed using a validated questionnaire. Repeated-measures analysis of variance was used to assess time and group interaction. Forty doctors were randomized. At baseline, the groups had similar airway experience (p = 0.34) and skill scores (p = 0.97). There was a significant interaction between study groups and changes over time for total skill scores (F[2, 37] = 4.06; p = 0.02). Although both the study groups had similar and significant improvement in total skills scores at the postworkshop assessment, the decline in total skills scores at delayed assessment (F[1, 38] = 5.64; p = 0.02) was significantly more in the recall-assisted reflection group when compared with the video-assisted reflection group. This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01). Better retention was predominantly in the nontechnical skills. The perceived quality of debrief was similar between the two groups.
CONCLUSION


When compared with recall, video-assisted reflection resulted in similar improvement in airway skills, but better retention over time.",2020,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"['junior critical care doctors', 'Intubating Critically Ill Patients', 'Junior critical care doctors', 'Forty doctors', 'University-affiliated tertiary care center', 'Trainees']","['video-assisted reflection or recall-assisted reflection group', 'Video', 'Video-assisted reflection']","['total skills scores', 'quality of debrief', 'airway skills', 'mean skill scores', 'Skills', 'recall bias and improve skills retention', 'total skill scores', 'Acquisition and Retention of Airway', 'similar airway experience', 'skill scores', 'Quality of debrief']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",40.0,0.212539,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"[{'ForeName': 'Shivesh', 'Initials': 'S', 'LastName': 'Prakash', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Laver', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Giresh', 'Initials': 'G', 'LastName': 'Chandran', 'Affiliation': 'Department of Anaesthesia, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Kerr', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Schuwirth', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bersten', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}]",Critical care medicine,['10.1097/CCM.0000000000004448']
1325,32619524,Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.,"BACKGROUND


Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
OBJECTIVES


The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes.
METHODS


In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076']
1326,32621905,The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).,"Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.",2020,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.",[],"['motivational interviewing-enhanced, integrated behavior therapy', 'video-based behavioral weight loss program and problem-solving therapy']",[],[],"[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]",[],,0.0347898,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Corina R', 'Initials': 'CR', 'LastName': 'Ronneberg', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98104, United States.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Wittels', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Amruta', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Aashutos S', 'Initials': 'AS', 'LastName': 'Patel', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Tessa L', 'Initials': 'TL', 'LastName': 'Eckley', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stetz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Departments of Biobehavioral Health and Medicine, Pennsylvania State University, University Park, PA 16802, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'National Institute of Mental Health (NIMH), National Institutes of Health, Bethesda, MD 20892, United States.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States; Department of Medicine, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States; Department of Medicine, University of Illinois at Chicago, Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106072']
1327,32658765,Assessment of stress markers in restrained individuals following physical stress with and without sham CED activation.,"INTRODUCTION


Law enforcement and pre-hospital care personnel often confront individuals who must be physically restrained. Many are under the influence of illicit substances, and law enforcement officers may need to use a controlled electrical device (CED) to gain control of the individual and they are often placed into the prone maximum restraint (PMR) position. These techniques have previously been evaluated for their physiologic effects. The purpose of this study was to investigate the psychological effects of anticipating and experiencing a sham CED activation in healthy human subjects who were exercised and restrained compared with no sham activation by assessing the differences in a panel of several known biomarkers of stress.
METHODS


We performed a randomized, crossover controlled human subject trial to study the stress associated with exercise, physical exhaustion, and restraint with and without an added psychological stress simulating the field use of a CED. Twenty five total subjects; each subject performed two different trials each consisting of a brief period of intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress. Blood samples were collected for analysis pre and post exercise, as well as 10 min after completion of the exercise. A panel of hormones and stress markers were measured.
RESULTS


We found no significant differences in any of the stress biomarkers measured between the two study groups. A trend towards higher levels of copeptin was measured in the sham CED activation arm.
CONCLUSION


During a brief period of intense exercise followed by the psychological stress of anticipated CED application, there did not appear to be statistically significant changes in the stress panel of biomarkers measured, only a trend towards significance for higher copeptin levels in the patients exposed to the psychological stress.",2020,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"['healthy human subjects', 'Twenty five total subjects']",['intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress'],"['stress biomarkers', 'levels of copeptin']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",25.0,0.0515782,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sloane', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA. Electronic address: csloane@ucsd.edu.'}, {'ForeName': 'Deborah C', 'Initials': 'DC', 'LastName': 'Mash', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Chan', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Kolkhorst', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University San Diego, CA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Neuman', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Castillo', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lasoff', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Wardi', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA; Division of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}]",Journal of forensic and legal medicine,['10.1016/j.jflm.2020.101982']
1328,32660041,"Effects of Rapid Recovery on Alcohol Hangover Severity: A Double-Blind, Placebo-Controlled, Randomized, Balanced Crossover Trial.","The aim of this study was to evaluate the efficacy of putative hangover treatment, Rapid Recovery, in mitigating alcohol hangover (AH) symptom severity. Using a double-blind, randomized, placebo-controlled, balanced crossover design, 20 participants attended the laboratory for two evenings of alcohol consumption, each followed by morning assessments of AH severity. Participants were administered Rapid Recovery and placebo on separate visits. In the first testing visit, participants self-administered alcoholic beverages of their choice, to a maximum of 1.3 g/kg alcohol. Drinking patterns were recorded and replicated in the second evening testing visit. In the morning visits, AH severity was assessed using questionnaires measuring AH symptom severity and sleep quality, computerized assessments of cognitive functioning as well as levels of blood biomarkers of liver function (gamma-glutamyl transferase (GGT)) and inflammation (high-sensitive C-reactive protein (hs-CRP)). There were no differences in the blood alcohol concentrations (BAC) obtained in the Rapid Recovery (mean = 0.096%) and placebo (mean = 0.097%) conditions. Participants reported significantly greater sleep problems in the Rapid Recovery compared to placebo condition, although this difference was no longer significant following Bonferroni's correction. There were no other significant differences between Rapid Recovery and placebo. These data suggest that Rapid Recovery has no significant effect on alcohol hangover nor on associated biomarkers.",2020,There were no differences in the blood alcohol concentrations (BAC) obtained in the Rapid Recovery (mean = 0.096%) and placebo (mean = 0.097%) conditions.,"['20 participants attended the laboratory for two evenings of alcohol consumption, each followed by morning assessments of AH severity']","['Placebo', 'placebo']","['questionnaires measuring AH symptom severity and sleep quality, computerized assessments of cognitive functioning as well as levels of blood biomarkers of liver function (gamma-glutamyl transferase (GGT)) and inflammation (high-sensitive C-reactive protein (hs-CRP', 'sleep problems', 'Alcohol Hangover Severity', 'mitigating alcohol hangover (AH) symptom severity', 'blood alcohol concentrations (BAC']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0393756', 'cui_str': 'Hangover'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0393756', 'cui_str': 'Hangover'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}]",20.0,0.271567,There were no differences in the blood alcohol concentrations (BAC) obtained in the Rapid Recovery (mean = 0.096%) and placebo (mean = 0.097%) conditions.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ayre', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Joris C', 'Initials': 'JC', 'LastName': 'Verster', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9072175']
1329,32660159,The Effectiveness of a Dyadic Pain Management Program for Community-Dwelling Older Adults with Chronic Pain: A Pilot Randomized Controlled Trial.,"BACKGROUND


Chronic pain is a major health problem among older adults and their informal caregivers, which has negative effects on their physical and psychological status. The dyadic pain management program (DPMP) is provided to community-dwelling older adults and informal caregivers to help the dyads reduce pain symptoms, improve the quality of life, develop good exercise habits, as well as cope and break the vicious circle of pain.
METHODS


A pilot randomized controlled trial was designed and all the dyads were randomly divided into two groups: the DPMP group and control group. Dyads in the DPMP group participated in an 8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information.
RESULTS


In total, 64 dyads participated in this study. For baseline comparisons, no significant differences were found between the two groups. After the interventions, the pain score was significantly reduced from 4.25 to 2.57 in the experimental group, respectively. In the repeated measures ANOVA, the differences in pain score (F = 107.787,  p  < 0.001,  d  = 0.777) was statistically significant for the group-by-time interaction. After the interventions, the experimental group participants demonstrated significantly higher pain self-efficacy compared with the control group (F = 80.535,  p  < 0.001,  d  = 0.722). Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
CONCLUSIONS


These results provide preliminary support for the effectiveness of a DPMP for relieving the symptoms of chronic pain among the elderly.",2020,"Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
","['Community-Dwelling Older Adults with Chronic Pain', 'older adults and their informal caregivers', '64 dyads participated in this study', 'community-dwelling older adults and informal caregivers']","['dyadic pain management program (DPMP', 'DPMP', 'Dyadic Pain Management Program', '8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information', 'DPMP group and control group']","['exercise time', 'pain score', 'pain self-efficacy']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",64.0,0.025096,"Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
","[{'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17144966']
1330,32660869,"A Double-Blind, Randomized, Placebo-Controlled Clinical Study of Trofinetide in the Treatment of Fragile X Syndrome.","BACKGROUND


We analyze the safety and tolerability of trofinetide and provide a preliminary evaluation of its efficacy in adolescent and adult males with fragile X syndrome.
METHODS


This study was an exploratory, phase 2, multicenter, double-blind, placebo-controlled, parallel group study of the safety and tolerability of orally administered trofinetide in 72 adolescent and adult males with fragile X syndrome. Subjects were randomly assigned in a 1:1:1 ratio to 35 or 70 mg/kg twice daily trofinetide or placebo for 28 days. Safety assessments included adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and concomitant medications. Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
RESULTS


Both 35 and 70 mg/kg dose levels of trofinetide were well tolerated and appeared to be generally safe. Trofinetide at the 70 mg/kg dose level demonstrated efficacy compared with placebo based on prespecified criteria. On the basis of a permutation test, the probability of a false-positive outcome for the achieved prespecified success was 0.045. In the group analysis, improvement from treatment baseline was demonstrated on three fragile X syndrome-specific outcome measures.
CONCLUSIONS


Trofinetide was well tolerated in adolescent and adult males with fragile X syndrome. Despite the relatively short duration of the study, a consistent signal of efficacy at the higher dose was observed in both caregiver and clinician assessments, based on a novel analytical model incorporating evaluation of multiple key symptom areas of fragile X syndrome. This finding suggests a potential for trofinetide treatment to provide clinically meaningful improvement in core fragile X syndrome symptoms.",2020,"Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
","['72 adolescent and adult males with fragile X syndrome', 'Fragile X Syndrome', 'adolescent and adult males with fragile X syndrome']","['trofinetide or placebo', 'trofinetide', 'Placebo', 'placebo']","['safety and tolerability', 'adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and concomitant medications']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016667', 'cui_str': 'Fragile X syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",72.0,0.270683,"Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Berry-Kravis', 'Affiliation': 'Department of Pediatrics, Rush University Medical Center, Chicago, Illinois; Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois; Department of Biochemistry, Rush University Medical Center, Chicago, Illinois. Electronic address: Elizabeth_Berry-Kravis@rush.edu.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Horrigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tartaglia', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Hagerman', 'Affiliation': 'Department of Pediatrics, University of California Davis MIND Institute, Sacramento, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Child and Adolescent Psychiatry, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Hatti', 'Affiliation': 'Suburban Research Associates, Media, Pennsylvania.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'AMO Pharma Ltd., London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yaroshinsky', 'Affiliation': 'Vital Systems, Inc., Rolling Meadows, Illinois.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Stoms', 'Affiliation': 'Vital Systems, Inc., Rolling Meadows, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Glass', 'Affiliation': 'Neuren Pharmaceuticals, Ltd., Melbourne, Victoria, Australia.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Jones', 'Affiliation': 'Neuren Pharmaceuticals, Ltd., Melbourne, Victoria, Australia.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.04.019']
1331,32661106,Hyperglycemia But Not Hyperinsulinemia Is Favorable for Exercise in Type 1 Diabetes: A Pilot Study.,"OBJECTIVE


To distinguish the effects of hyperglycemia and hyperinsulinemia on exercise-induced increases in R d  and endogenous glucose production (EGP) in type 1 diabetes.
RESEARCH DESIGN AND METHODS


We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI). Glucose fluxes were measured using [6,6- 2 H 2 ] glucose before, during, and after 60 min of exercise.
RESULTS


R d  increased ( P  < 0.01) with exercise within groups while peak R d  during exercise was lower ( P  < 0.01) in participants with type 1 diabetes than participants without diabetes during all visits. In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI. This demonstrates that hyperinsulinemia, but not hyperglycemia, blunts the compensatory exercise-induced increase in EGP in type 1 diabetes.
CONCLUSIONS


The data from this pilot study indicate that  1 ) Exercise-induced compensatory increase in EGP was inhibited in participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia;  2 ) In contrast, in participants without diabetes, exercise-induced increase in EGP was inhibited only during combined hyperinsulinemia and hyperglycemia. Taken together, these results suggest that low insulin coupled with euglycemia or modest hyperglycemia appear to be the most favorable milieu for type 1 diabetes during exercise.",2020,"In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","['type 1 diabetes', 'participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia;  2 ', 'We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI']",[],"['R d  and endogenous glucose production (EGP', 'compensatory increase in EGP', 'Hyperglycemia', 'Glucose fluxes', 'EGP']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205452', 'cui_str': '6'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}]",[],"[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",6.0,0.031498,"In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Romeres', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Olson', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rickey', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cobelli', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dalla Man', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}]",Diabetes care,['10.2337/dc20-0611']
1332,32627420,"A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis.","ABP 798 is a proposed biosimilar to rituximab reference product (RP), an anti-CD20 monoclonal antibody. Pharmacokinetics (PK), pharmacodynamics (PD), and safety results from the comparative clinical study that evaluated the PK, PD, safety, efficacy, and immunogenicity of ABP 798 versus rituximab RP are presented here. Subjects with moderate to severe rheumatoid arthritis (RA) received 2 doses of ABP 798, United States-sourced RP (rituximab US) or European Union-sourced RP (rituximab EU), each consisting of two 1000-mg infusions 2 weeks apart. For the second dose (week 24), ABP 798- and rituximab EU-treated subjects received the same treatment; rituximab US-treated subjects transitioned to ABP 798. End points included area under the serum concentration-time curve from time 0 extrapolated to infinity and maximum observed serum concentration following the second infusion of the first dose (PK) and percentage of subjects with complete CD19+ cell depletion days 1-33 (PD). Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25. Complete CD19+ B-cell depletion on day 3 among groups confirmed PD similarity. These findings demonstrated PK/PD similarity between ABP 798 and rituximab RP in subjects with moderate to severe RA.",2020,Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25.,"['Subjects With Moderate to Severe Rheumatoid Arthritis', 'subjects with moderate to severe RA', 'Subjects with moderate to severe rheumatoid arthritis (RA']","['ABP 798, United States-sourced RP (rituximab US) or European Union-sourced RP (rituximab EU']","['PK, PD, safety, efficacy, and immunogenicity', 'Complete CD19+ B-cell depletion', 'area under the serum concentration-time curve', 'Pharmacokinetics (PK), pharmacodynamics (PD), and safety']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0433337,Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25.,"[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Clinical R&D, Biosimilars, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chow', 'Affiliation': 'Clinical Pharmacology M&S, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gessner', 'Affiliation': 'Clinical Immunology, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Clinical R&D, Biosimilars, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, Texas, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.845']
1333,32622871,Treatment of postmenopausal osteoporosis with bone-forming and antiresorptive treatments: Combined and sequential approaches.,"Efficient therapies are available for the treatment of osteoporosis. Bisphosphonates and denosumab are the most commonly used antiresorptive therapies. Despite differences in the increase in bone mineral density seen with these drugs, the reductions in fracture risk are similar; 50-70%, 20%, and 40% for vertebral, non-vertebral and hip fractures, respectively. The bone-forming treatments; teriparatide and abaloparatide increase bone mineral density more than the antiresorptives and the reductions in fracture risk are 85% and 40-50% for vertebral and non-vertebral fractures, respectively, compared to placebo. The VERO study demonstrated a >50% reduction in vertebral and clinical fractures in women treated with teriparatide compared to risedronate. The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years. The evidence for combination therapy targeting both resorption and formation is limited as only short-term studies with BMD as the endpoint have been performed. All bone-forming and dual-action treatments increase BMD and reduce the fracture risk, however, the effect wears off with time and treatment is therefore only temporary and should be followed by antiresorptive treatment with a bisphosphonate or denosumab. The sequence of treatment matters as the BMD response to teriparatide is reduced in patients previously treated with bisphosphonates; however, based on the findings of the VERO trial, the anti-fracture efficacy of bone-forming treatment in comparison with risedronate seems to be preserved after bisphosphonate therapy. The DATA study suggested that transitioning from denosumab to teriparatide is problematic due to the increase in bone resorption occurring after stopping denosumab. Studies have shown further improvements in BMD when transitioning from oral bisphosphonates to zoledronic acid or denosumab. Management of osteoporosis will in many patients include a long-term treatment plan. This will often include sequential therapy which in severe cases preferably should start with bone-forming followed by antiresorptive treatment. The severity of osteoporosis, reaching a treatment goal, and responding to treatment failure are important factors determining the treatment sequence in the individual patient.",2020,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","['patients previously treated with', 'postmenopausal osteoporosis with bone-forming and antiresorptive treatments']","['teriparatide', 'zoledronic acid or denosumab', 'Bisphosphonates and denosumab', 'bisphosphonates', 'alendronate', 'bisphosphonate or denosumab', 'risedronate', 'placebo']","['bone mineral density', 'vertebral and clinical fractures', 'risk of vertebral, non-vertebral and hip fractures', 'BMD', 'risk of vertebral and clinical fractures', 'fracture risk', 'BMD response', 'bone resorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C1286272', 'cui_str': 'Form of bone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",,0.0195905,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","[{'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Endocrinology and Internal Medicine, Palle Juul Jensen Boulevard 115, DK8200 Aarhus N, Denmark. Electronic address: bente.langdahl@aarhus.rm.dk.'}]",Bone,['10.1016/j.bone.2020.115516']
1334,32622904,"Effects of acute inspiratory loading during treadmill running on cerebral, locomotor and respiratory muscle oxygenation in women soccer players.","Respiratory limitation can be a primary mechanism for exercise cessation in female athletes. This study aimed to assess the effects of inspiratory loading (IL) on intercostal muscles (IM), vastus lateralis (VL) and cerebral (Cox) muscles oxygenation in women soccer players during high-intensity dynamic exercise. Ten female soccer players were randomized to perform in order two constant-load tests on a treadmill until the exhaustion time (Tlim) (100 % of maximal oxygen uptake- V˙O 2 ). They breathed freely or against a fixed inspiratory loading (IL) of 41 cm H 2 O (∼30 % of maximal inspiratory pressure). Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb]), total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI) were obtained by NIRs. Also, blood lactate [La - ] was obtained. IL significantly reduced Tlim (224 ± 54 vs 78 ± 20; P < 0.05) and increased [La - ], V˙O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05). IL also resulted in decrease of Δ[OxyHb] of Cox and IM during exercise compared with rest condition. In addition, decrease of Δ[OxyHb] was observed on IM during exercise when contrasted with Sham (P < 0.05). Furthermore, significant higher Δ[DeoxyHb] of IM and significant lower Δ[DeoxyHb] of Cox were observed when IL was applied during exercise in contrast with Sham (P < 0.05). These results were accompanied with significant reduction of Δ[tHb] and ΔTSI of IM and VL when IL was applied (P < 0.05). High-intensity exercise with IL decreased respiratory and peripheral muscle oxygenation with negative impact on exercise performance. However, the increase in ventilatory work did not impact cerebral oxygenation in soccer players.",2020,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","['women soccer players', 'Ten female soccer players', 'female athletes', 'women soccer players during high-intensity dynamic exercise', 'soccer players']","['acute inspiratory loading during treadmill running', 'Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb', 'High-intensity exercise with IL']","['Δ[OxyHb', 'intercostal (IM), vastus lateralis (VL) and cerebral (Cox) oxygenation', 'total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI', 'Δ[DeoxyHb', 'Δ[tHb] and ΔTSI of IM and VL', 'increased [La-], V̇O 2 , respiratory cycles and dyspnea', 'blood lactate [La', 'cerebral, locomotor and respiratory muscle oxygenation', 'exercise performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0592251,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","[{'ForeName': 'Flavia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Archiza', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Trimer', 'Affiliation': 'Physical Therapy Department, University of Santa Cruz Do Sul - UNISC, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Bonjorno-Junior', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Claudio Ricardo', 'Initials': 'CR', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Cleiton A', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103488']
1335,32623088,Effectiveness of Intramuscular Electrical Stimulation on Postsurgical Nociceptive Pain for Patients Undergoing Open Pancreaticoduodenectomy: A Randomized Clinical Trial.,"BACKGROUND


After pylorus-preserving pancreaticoduodenectomy (PPPD), incision and suture of the abdominal muscles cause inflammatory changes and elicit somatic pain that deteriorates the quality of life. There have been no previous reports on needle electrical twitch obtaining intramuscular stimulation (NETOIMS) in abdominal open operation; this study aimed to apply NETOIMS for postoperative somatic pain in patients undergoing PPPD as a new treatment modality for pain control.
METHODS


Between June 2018 and January 2019, 44 patients who underwent PPPD were randomly assigned to a control group and the NETOIMS group. The NETOIMS group received NETOIMS in the transverse abdominis muscle under ultrasound guidance right after operation under general anesthesia. The pain score (visual analog scale), peak cough flow (PCF), and gait speed were repetitively measured from 1 day before operation to 2 weeks after discharge as scheduled. Data were analyzed by the linear mixed model and repeated-measures analysis of variance.
RESULTS


Of the 44 patients recruited, data from 38 patients were finally analyzed. The pain scores were significantly lower in the NETOIMS group after PPPD (p = 0.01). Although the PCF at each measuring time point did not show inter-group difference (p = 0.20), improvement of PCF from the second day after operation to discharge was greater (p = 0.02) and gait speed improved significantly faster (p < 0.01) in the NETOIMS group than in the control group.
CONCLUSIONS


NETOIMS helps in rapid reduction of postoperative somatic pain developed after PPPD and in improvement of PCF and gait speed.",2020,"Although the PCF at each measuring time point did not show inter-group difference (P = 0.20), improvement of PCF from the second day of surgery to discharge was greater (P = 0.02) and gait speed improved significantly faster (P < 0.01) in the NETOIMS group than in the control group.
","['44 patients recruited, data of 38 patients were finally analyzed', 'Patients Undergoing Open Pancreaticoduodenectomy', 'after surgery under general anesthesia', 'Between June 2018 and January 2019, 44 patients who underwent PPPD', 'patients undergoing PPPD as a new treatment modality for pain control']","['transverse abdominis muscle under ultrasound guidance right', 'Intramuscular Electrical Stimulation']","['pain scores', 'gait speed', 'PCF and gait speed', 'Postsurgical Nociceptive Pain', 'improvement of PCF', 'pain score (visual analog scale, VAS), peak cough flow (PCF), and gait speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C3178766', 'cui_str': 'Nociceptive Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",38.0,0.0740017,"Although the PCF at each measuring time point did not show inter-group difference (P = 0.20), improvement of PCF from the second day of surgery to discharge was greater (P = 0.02) and gait speed improved significantly faster (P < 0.01) in the NETOIMS group than in the control group.
","[{'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Rehabilitation Institute of Neuromuscular Disease, Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung Sun', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Rehabilitation Institute of Neuromuscular Disease, Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Ghil', 'Initials': 'YG', 'LastName': 'Park', 'Affiliation': 'Rehabilitation Institute of Neuromuscular Disease, Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sanghoon', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Gangnam Severance Hospital, Department Rehabilitation Medicine, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Gangnam Severance Hospital, Department Rehabilitation Medicine, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sangwon', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Gangnam Severance Hospital, Department Rehabilitation Medicine, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Jun', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon Seong', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jspark330@yuhs.ac.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.06.008']
1336,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1337,32624377,"Transdermal buprenorphine patch versus oral celecoxib for pain management after total knee arthroplasty: An open- label, randomized controlled trial.","BACKGROUND


This study was performed to evaluate the analgesic efficacy and safety of transdermal buprenorphine (TDB) patched for post-operative pain control after total knee arthroplasty (TKA). The hypothesis was that patients receiving the TDB patch would have less pain in comparison to those treated with the oral COX-2 inhibitor celecoxib without increasing side effects.
PATIENTS AND METHODS


A total of 160 patients scheduled for primary TKA were randomly assigned to two groups: patients provided the TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group). The outcomes were pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively.
RESULTS


The total morphine given during the first 72h post-operatively was significantly lower in the TDB group than CX group. The VAS scores were significantly lower in the TDB group than CX group during rest at 2, 4, 6, 12, 24 and 48h post-operatively, and during activity at 12, 24 and 48h and 3 days post-operatively. The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group. In addition, the Lysholm score was significantly higher in the TDB group on PD 3. There were no remarkable adverse events in either group.
DISCUSSION


Use of the TDB patch provides effective pain relief and reduces the requirement for rescue morphine without increasing side effects in comparison with oral celecoxib during the early post-operative stage following TKA.
LEVEL OF EVIDENCE


II.",2020,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","['160 patients scheduled for primary TKA', 'pain management after total knee arthroplasty']","['Transdermal buprenorphine patch versus oral celecoxib', 'TDB', 'oral COX-2 inhibitor celecoxib', 'TDB patch', 'celecoxib', 'transdermal buprenorphine', 'TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group', 'CX']","['mean range of motion on post-operative days (PD', 'Lysholm score', 'analgesic efficacy and safety', 'effective pain relief', 'adverse events', 'pain', 'pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively', 'VAS scores']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",160.0,0.0687527,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","[{'ForeName': 'Xinxian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Linghui', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'The Radiology Department of Wenzhou Seventh Hospital, Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Haixiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Yuezheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China. Electronic address: huyuezheng3@163.com.""}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.010']
1338,32632523,Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity.,"BACKGROUND


Due to the SARS-CoV2 pandemic, medical face masks are widely recommended for a large number of individuals and long durations. The effect of wearing a surgical and a FFP2/N95 face mask on cardiopulmonary exercise capacity has not been systematically reported.
METHODS


This prospective cross-over study quantitated the effects of wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask (ffpm) in 12 healthy males (age 38.1 ± 6.2 years, BMI 24.5 ± 2.0 kg/m 2 ). The 36 tests were performed in randomized order. The cardiopulmonary and metabolic responses were monitored by ergo-spirometry and impedance cardiography. Ten domains of comfort/discomfort of wearing a mask were assessed by questionnaire.
RESULTS


The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± 1.6 l/s; p < 0.001). The maximum power was 269 ± 45, 263 ± 42 and 277 ± 46 W with sm, ffpm and nm, respectively; p = 0.002; the ventilation was significantly reduced with both face masks (131 ± 28 vs 114 ± 23 vs 99 ± 19 l/m; p < 0.001). Peak blood lactate response was reduced with mask. Cardiac output was similar with and without mask. Participants reported consistent and marked discomfort wearing the masks, especially ffpm.
CONCLUSION


Ventilation, cardiopulmonary exercise capacity and comfort are reduced by surgical masks and highly impaired by FFP2/N95 face masks in healthy individuals. These data are important for recommendations on wearing face masks at work or during physical exercise.",2020,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","['12 healthy males (age 38.1\u2009±\u20096.2\xa0years, BMI 24.5\u2009±\u20092.0\xa0kg/m 2 ', 'healthy individuals']","['wearing a surgical and a FFP2/N95 face mask', 'wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask', 'surgical and FFP2/N95 face masks']","['Cardiac output', 'Peak blood lactate response', 'ventilation', 'pulmonary function parameters', 'cardiopulmonary exercise capacity', 'cardiopulmonary and metabolic responses']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",12.0,0.0184074,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Fikenzer', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany. sven.fikenzer@medizin.uni-leipzig.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Uhe', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lavall', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Rudolph', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hepp', 'Affiliation': 'Klinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01704-y']
1339,32632894,Temozolomide and seizure outcomes in a randomized clinical trial of elderly glioblastoma patients.,"INTRODUCTION


Tumor-related epilepsy may respond to chemotherapy. In a previously-published multi-centre randomized clinical trial of 562 elderly glioblastoma patients, temozolomide plus short-course radiotherapy conferred a survival benefit over radiotherapy alone. Seizure outcomes were not reported.
METHODS


We performed an unplanned secondary analysis of this trial's data. The trial design has been previously reported. Seizures were recorded by clinicians as adverse events and by patients in quality of life questionnaires. A Chi-square test of seizure rates between the two groups (α = 0.05) and a Kaplan-Meier estimator of time-to-first self-reported seizure were planned.
RESULTS


Almost all patients were followed until they died. In the radiotherapy alone group, 68 patients (24%) had a documented or self-reported seizure versus 83 patients (30%) in the temozolomide plus radiotherapy group, Chi-square analysis showed no difference (p = 0.15). Patients receiving radiotherapy alone tended to develop seizures earlier than those receiving temozolomide plus radiotherapy (p = 0.054). Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02).
CONCLUSIONS


This study was not powered to detect differences in seizure outcomes, but temozolomide seemed to have minimal impact on seizure control in elderly patients with glioblastoma.
CLINICAL TRIAL REGISTRATION


NCT00482677 2007-06-05.",2020,"Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02).
","['elderly glioblastoma patients', '562 elderly glioblastoma patients', 'elderly patients with glioblastoma']","['temozolomide plus short-course radiotherapy', 'temozolomide', 'Temozolomide', 'radiotherapy', 'temozolomide plus radiotherapy']","['seizure rates', 'develop seizures earlier', 'survival benefit', 'overall survival', 'Seizures', 'documented or self-reported seizure', 'quality of life questionnaires']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",562.0,0.441488,"Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02).
","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Climans', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada. seth.climans@uhn.com.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Azienda Unità Sanitaria Locale - Istituto di Ricovero e Cura a Carattere Scientifico Istituto delle Scienze Neurologiche, Bologna, Italy.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Cairncross', 'Affiliation': 'University of Calgary, Calgary, Canada.'}, {'ForeName': 'Keyue', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': ""The Canadian Cancer Trials Group, Queen's University, Kingston, Canada.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fay', 'Affiliation': 'University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Normand', 'Initials': 'N', 'LastName': 'Laperriere', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Menten', 'Affiliation': 'University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nishikawa', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': ""The Canadian Cancer Trials Group, Queen's University, Kingston, Canada.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Perry', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Roa', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, University of Heidelberg and Neurooncology Program, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Winch', 'Affiliation': ""The Canadian Cancer Trials Group, Queen's University, Kingston, Canada.""}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Mason', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03573-x']
1340,32628385,[Hypertrophy of palatine tonsils - possible treatment approaches].,"OBJECTIVE


To evaluate the effectiveness of different approaches to the treatment of patients with hypertrophy of the palatine tonsils (HPT).
MATERIAL AND METHODS


90 children with HPT of II-III degree and 20 healthy children (group 1) aged from 3 to 7 years were included in the study. Children with HPT were divided into three groups: group 2 - children who underwent tonsillotomy ( n =30), group 3 - children who underwent conservative treatment, including only topical use of Polyoxidonium ( n =30), group 4 - children who underwent complex treatment (tonsillotomy with subsequent local use of Polyoxidonium), (n=30). The severity of nasal breathing disturbances on a visual analogue scale, the average number of acute respiratory viral infections 6 months before and after treatment, the level of gene expression of antimicrobial peptides before and after treatment, the degree of hypertrophy of the palatine tonsils and spleen with an assessment of the echostructure and determination of the spleen mass coefficient using Ultrasound were evaluated in the study.
RESULTS


In children receiving only Polyoxidonium, there was a decrease in the severity of nasal breathing disorders, a decrease in the frequency of acute respiratory viral infections, an increase in the expression of antimicrobial peptide genes compared to the initial level of these indicators. Comprehensive treatment of children with HPT (group 4) showed a significant decrease in the severity of nasal breathing disorders, a decrease in the average number of acute respiratory infections within 6 months, an increase in the expression of antimicrobial peptide genes compared to children who underwent only tonsillotomy (group 2) or only conservative therapy (group 3).
CONCLUSION


It is proved that the use of Polyoxidonium in the complex treatment of HPT is clinically effective and safe.",2020,"Comprehensive treatment of children with HPT (group 4) showed a significant decrease in the severity of nasal breathing disorders, a decrease in the average number of acute respiratory infections within 6 months, an increase in the expression of antimicrobial peptide genes compared to children who underwent only tonsillotomy (group 2) or only conservative therapy (group 3).
","['90 children with HPT of II-III degree and 20 healthy children (group 1) aged from 3 to 7 years were included in the study', 'Children with HPT', 'children with', 'patients with hypertrophy of the palatine tonsils (HPT']","['tonsillotomy', 'conservative treatment, including only topical use of Polyoxidonium', 'complex treatment (tonsillotomy with subsequent local use of Polyoxidonium', 'Polyoxidonium', 'HPT']","['severity of nasal breathing disorders', 'severity of nasal breathing disturbances', 'average number of acute respiratory infections', 'frequency of acute respiratory viral infections', 'expression of antimicrobial peptide genes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0193930', 'cui_str': 'Incision of tonsil'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C2716079', 'cui_str': 'Polyoxidonium'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",90.0,0.0182445,"Comprehensive treatment of children with HPT (group 4) showed a significant decrease in the severity of nasal breathing disorders, a decrease in the average number of acute respiratory infections within 6 months, an increase in the expression of antimicrobial peptide genes compared to children who underwent only tonsillotomy (group 2) or only conservative therapy (group 3).
","[{'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Karpova', 'Affiliation': 'Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Gankovskaya', 'Affiliation': 'Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Vozgoment', 'Affiliation': 'Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Ya S', 'Initials': 'YS', 'LastName': 'Avalyan', 'Affiliation': 'Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'I Yu', 'Initials': 'IY', 'LastName': 'Kulikova', 'Affiliation': 'Lomonosov Institute of Fine Chemical Technologies, Russian Technological University, Moscow, Russia.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Merkusheva', 'Affiliation': 'Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Khasanova', 'Affiliation': 'Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.'}]",Vestnik otorinolaringologii,['10.17116/otorino20208503157']
1341,32629403,Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.,"BACKGROUND


Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability.
METHODS


This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability.
RESULTS


Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
CONCLUSIONS


Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.",2020,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
",['healthy subjects'],"['DMF', 'Monomethyl fumarate (MMF', 'MMF 190 mg vs DMF']","['LSMean AUC values', 'MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events', 'gastrointestinal tolerability profile', 'derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS', 'Area Under the Curve (AUC', 'safety/tolerability', 'Abdominal Pain', 'GI tolerability', 'severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C3848524', 'cui_str': 'monomethyl fumarate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0797155,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wynn', 'Affiliation': 'Consultants in Neurology, Ltd, Northbrook, IL 60062, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Lategan', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA. Electronic address: Lategan@bannerls.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Sprague', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Franck S', 'Initials': 'FS', 'LastName': 'Rousseau', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX 78681, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102335']
1342,32629757,The Effect of Vitamin D 3  Supplementation on Physical Capacity among Active College-Aged Males.,"Vitamin D 3  supplementation can affect strength and power; however, the effect on both aerobic and anaerobic performance remains unclear. Here, we investigate the effects of eight weeks of a high dose of vitamin D 3  supplementation and its impact on circulating 25-hydroxyvitamin D (25-OH-D 3 ) concentrations and selected indicators of physical capacity. Subjects ( n  = 28, age 21.1 ± 1.6) were divided into two groups: supplemented (SUP), which was given 6000 IU of vitamin D 3  daily for eight weeks; and placebo group (PLA). Serum 25-OH-D 3  concentrations were determined in pre- and post-intervention. Aerobic (VO 2max  test) and anaerobic (Wingate Anaerobic Test) capacity were determined before and after the supplementation. The mean baseline concentration of 25-OH-D 3  was recognized as deficient (20 ng/mL) and significantly increased over time in the supplemented group ( p  < 0.01, η 2  = 0.86), whilst it remained unchanged in the placebo group. Moreover, the supplementation caused a significant improvement in maximal aerobic ( p  < 0.05, η 2  = 0.27) and anaerobic power ( p  < 0.01, η 2  = 0.51) whereas no changes were observed in PLA group. The VO 2max  differences were also significant in the supplemented group ( p  < 0.05). In summary, the changes in aerobic and anaerobic capacity observed in this study were associated with a serum concentration of 25-OH-D 3 . Our data imply that vitamin D 3  supplementation with a dose of 6000 IU daily for eight weeks is sufficient to improve physical capacity and vitamin D 3  status.",2020,"Moreover, the supplementation caused a significant improvement in maximal aerobic ( p  < 0.05, η 2  = 0.27) and anaerobic power ( p  < 0.01, η 2  = 0.51) whereas no changes were observed in PLA group.","['Subjects ( n  = 28, age 21.1 ± 1.6', 'Active College-Aged Males']","['Vitamin D 3  supplementation', 'vitamin D 3  supplementation', 'Vitamin D 3  Supplementation', 'vitamin D 3  daily for eight weeks; and placebo', 'placebo']","['anaerobic power', 'aerobic and anaerobic capacity', 'Serum 25-OH-D 3  concentrations', 'maximal aerobic', 'Physical Capacity', 'circulating 25-hydroxyvitamin D (25-OH-D 3 ) concentrations and selected indicators of physical capacity', 'mean baseline concentration of 25-OH-D 3', 'Aerobic (VO 2max  test) and anaerobic (Wingate Anaerobic Test) capacity']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0716502,"Moreover, the supplementation caused a significant improvement in maximal aerobic ( p  < 0.05, η 2  = 0.27) and anaerobic power ( p  < 0.01, η 2  = 0.51) whereas no changes were observed in PLA group.","[{'ForeName': 'Sylwester', 'Initials': 'S', 'LastName': 'Kujach', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Lyzwinski', 'Affiliation': 'Department of Sport and Physical Education, Medical University of Gdansk, M. Skłodowskiej-Curie 3a, 80-210 Gdansk, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Chroboczek', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Bialowas', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Faculty of Health Sciences, Department of Bioenergetics and Physiology of Exercise, Medical University of Gdansk, Debinki 1, 80-211 Gdansk, Poland.'}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Laskowski', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}]",Nutrients,['10.3390/nu12071936']
1343,32629906,"Wheat Sensitivity and Functional Dyspepsia: A Pilot, Double-Blind, Randomized, Placebo-Controlled Dietary Crossover Trial with Novel Challenge Protocol.","Introduction:  Functional dyspepsia (FD), characterised by symptoms of epigastric pain or early satiety and post prandial distress, has been associated with duodenal eosinophilia, raising the possibility that it is driven by an environmental allergen. Non-coeliac gluten or wheat sensitivity (NCG/WS) has also been associated with both dyspeptic symptoms and duodenal eosinophilia, suggesting an overlap between these two conditions. The aim of this study was to evaluate the role of wheat (specifically gluten and fructans) in symptom reduction in participants with FD in a pilot randomized double-blind, placebo controlled, dietary crossover trial.  Methods:  Patients with Rome III criteria FD were recruited from a single tertiary centre in Newcastle, Australia. All were individually counselled on a diet low in both gluten and fermentable oligo-, di-, mono-saccharides, and polyols (FODMAPs) by a clinical dietitian, which was followed for four weeks (elimination diet phase). Those who had a >30% response to the run-in diet, as measured by the Nepean Dyspepsia Index, were then re-challenged with 'muesli' bars containing either gluten, fructan, or placebo in randomised order. Those with symptoms which significantly reduced during the elimination diet, but reliably reappeared (a mean change in overall dyspeptic symptoms of >30%) with gluten or fructan re-challenge were deemed to have wheat induced FD.  Results:  Eleven participants were enrolled in the study (75% female, mean age 43 years). Of the initial cohort, nine participants completed the elimination diet phase of whom four qualified for the rechallenge phase. The gluten-free, low FODMAP diet led to an overall (albeit non-significant) improvement in symptoms of functional dyspepsia in the diet elimination phase (mean NDI symptom score 71.2 vs. 47.1,  p  = 0.087). A specific food trigger could not be reliably demonstrated.  Conclusions:  Although a gluten-free, low-FODMAP diet led to a modest overall reduction in symptoms in this cohort of FD patients, a specific trigger could not be identified. The modified Salerno criteria for NCG/WS identification trialled in this dietary rechallenge protocol was fit-for-purpose. However, larger trials are required to determine whether particular components of wheat induce symptoms in functional dyspepsia.",2020,"The gluten-free, low FODMAP diet led to an overall (albeit non-significant) improvement in symptoms of functional dyspepsia in the diet elimination phase (mean NDI symptom score 71.2 vs. 47.1,  p  = 0.087).","['participants with FD', 'Patients with Rome III criteria FD were recruited from a single tertiary centre in Newcastle, Australia', 'Eleven participants were enrolled in the study (75% female, mean age 43 years']","['placebo', 'wheat (specifically gluten and fructans', 'Placebo', 'wheat sensitivity (NCG/WS']","['symptoms of functional dyspepsia', 'Wheat Sensitivity and Functional Dyspepsia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027983', 'cui_str': 'Newcastle disease'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",11.0,0.379517,"The gluten-free, low FODMAP diet led to an overall (albeit non-significant) improvement in symptoms of functional dyspepsia in the diet elimination phase (mean NDI symptom score 71.2 vs. 47.1,  p  = 0.087).","[{'ForeName': 'Michael D E', 'Initials': 'MDE', 'LastName': 'Potter', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Kerith', 'Initials': 'K', 'LastName': 'Duncanson', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Walker', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Keely', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}]",Nutrients,['10.3390/nu12071947']
1344,32629992,Effects of Dietary Fibres on Acute Indomethacin-Induced Intestinal Hyperpermeability in the Elderly: A Randomised Placebo Controlled Parallel Clinical Trial.,"The effect of dietary fibres on intestinal barrier function has not been well studied, especially in the elderly. We aimed to investigate the potential of the dietary fibres oat β-glucan and wheat arabinoxylan to strengthen the intestinal barrier function and counteract acute non-steroid anti-inflammatory drug (indomethacin)-induced hyperpermeability in the elderly. A general population of elderly subjects (≥65 years,  n  = 49) was randomised to a daily supplementation (12g/day) of oat β-glucan, arabinoxylan or placebo (maltodextrin) for six weeks. The primary outcome was change in acute indomethacin-induced intestinal permeability from baseline, assessed by an in vivo multi-sugar permeability test. Secondary outcomes were changes from baseline in: gut microbiota composition, systemic inflammatory status and self-reported health. Despite a majority of the study population (85%) showing a habitual fibre intake below the recommendation, no significant effects on acute indomethacin-induced intestinal hyperpermeability in vivo or gut microbiota composition were observed after six weeks intervention with either dietary fibre, compared to placebo.",2020,"Despite a majority of the study population (85%) showing a habitual fibre intake below the recommendation, no significant effects on acute indomethacin-induced intestinal hyperpermeability in vivo or gut microbiota composition were observed after six weeks intervention with either dietary fibre, compared to placebo.","['Elderly', 'A general population of elderly subjects (≥65 years,  n  = 49']","['dietary fibres oat β-glucan and wheat arabinoxylan', 'Placebo', 'dietary fibres', 'Dietary Fibres', 'oat β-glucan, arabinoxylan or placebo (maltodextrin', 'placebo']","['change in acute indomethacin-induced intestinal permeability from baseline, assessed by an in vivo multi-sugar permeability test', 'Intestinal Hyperpermeability', 'intestinal hyperpermeability in vivo or gut microbiota composition', 'changes from baseline in: gut microbiota composition, systemic inflammatory status and self-reported health']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.287326,"Despite a majority of the study population (85%) showing a habitual fibre intake below the recommendation, no significant effects on acute indomethacin-induced intestinal hyperpermeability in vivo or gut microbiota composition were observed after six weeks intervention with either dietary fibre, compared to placebo.","[{'ForeName': 'John-Peter', 'Initials': 'JP', 'LastName': 'Ganda Mall', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Fart', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Sabet', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Carl Mårten', 'Initials': 'CM', 'LastName': 'Lindqvist', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Nestestog', 'Affiliation': 'Genetic Analysis AS, Kabelgata 8, 0580 Oslo, Norway.'}, {'ForeName': 'Finn Terje', 'Initials': 'FT', 'LastName': 'Hegge', 'Affiliation': 'Genetic Analysis AS, Kabelgata 8, 0580 Oslo, Norway.'}, {'ForeName': 'Åsa V', 'Initials': 'ÅV', 'LastName': 'Keita', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, 581 85 Linköping, Sweden.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brummer', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Schoultz', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}]",Nutrients,['10.3390/nu12071954']
1345,32662699,Can Brief Email Guidance Enhance the Effects of an Internet Intervention for People with Problematic Alcohol Use? A Randomized Controlled Trial.,"BACKGROUND


Some research suggests that internet interventions aimed at people with problematic alcohol use are more effective when provided with guidance from a therapist or coach.  Purpose/Objectives:  This trial intended to compare the effects of a previously evaluated internet intervention for people with problematic alcohol use when delivered with or without brief email guidance.  Methods:  Using online advertising, 238 participants, 18 years or older, were recruited and randomized to receive access to the Internet intervention Alcohol Help Center with or without brief email guidance from a health educator. The guidance consisted of at least four structured, slightly individualized emails delivered during the first two weeks after randomization. Participants were followed up at 3 and 6 months.  Results:  Number of log-ins did not differ significantly between groups throughout the follow-up period. The follow-up rate at 6 months was 47.0%. Generalized estimating equations run on the primary (standard drinks in preceding week/heavy drinking days in preceding week) and secondary outcome variables (AUDIT, AUDIT-C, quality of life) revealed no significant differences between the interventions on any of the outcomes.  Conclusions/Importance:  The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.",2020,The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.,"['people with problematic alcohol', 'People with Problematic Alcohol Use', 'problem drinkers', '238 participants, 18\u2009years or older']","['Internet Intervention', 'internet intervention', 'Internet intervention Alcohol Help Center with or without brief email guidance from a health educator']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}]",[],238.0,0.0894453,The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sundström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatric Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schell', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Wardell', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Godinho', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Cunningham', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}]",Substance use & misuse,['10.1080/10826084.2020.1788087']
1346,32684537,Clopidogrel Monotherapy vs. Aspirin Monotherapy Following Short-Term Dual Antiplatelet Therapy in Patients Receiving Everolimus-Eluting Coronary Stent Implantation.,"BACKGROUND


There is a scarcity of data on short-duration dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy as compared with aspirin monotherapy after percutaneous coronary intervention (PCI).Methods and Results:STOPDAPT-1 is a prospective trial enrolling patients who agreed to 3-month DAPT followed by aspirin monotherapy after everolimus-eluting stent (EES) implantation. STOPDAPT-2 is a randomized trial comparing 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after EES implantation. We compared the clinical outcomes of patients assigned to the 1-month DAPT group in STOPDAPT-2 and the 3-month DAPT group enrolled in STOPDAPT-1. The current study population consisted of 1,480 patients in STOPDAPT-2 and 1,339 patients in STOPDAPT-1. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis and TIMI major/minor bleeding. Cumulative 1-year incidence of the primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (2.3% vs. 2.3%, P=0.98). After adjusting for confounders, there was no excess risk of STOPDAPT-2 relative to STOPDAPT-1 for the primary endpoint. Between 3 and 12 months, the cumulative incidence of primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (1.7% vs. 1.6%, P=0.77).
CONCLUSIONS


The effect of 1-month DAPT followed by clopidogrel monotherapy on clinical outcomes was similar to that of 3-month DAPT followed by aspirin monotherapy in patients receiving PCI.",2020,"Cumulative 1-year incidence of the primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (2.3% vs. 2.3%, P=0.98).","['patients assigned to the 1-month DAPT group in STOPDAPT-2 and the 3-month DAPT group enrolled in STOPDAPT-1', 'enrolling patients who agreed to 3-month DAPT followed by aspirin monotherapy after everolimus-eluting stent (EES) implantation', 'Patients', 'patients receiving PCI', '1,480 patients in STOPDAPT-2 and 1,339 patients in STOPDAPT-1']","['clopidogrel monotherapy', 'DAPT', 'aspirin monotherapy', 'Clopidogrel Monotherapy vs. Aspirin Monotherapy', 'Everolimus-Eluting Coronary Stent Implantation']","['cumulative incidence of primary endpoint', 'Cumulative 1-year incidence', 'composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis and TIMI major/minor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",1480.0,0.0987282,"Cumulative 1-year incidence of the primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (2.3% vs. 2.3%, P=0.98).","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Natsuaki', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kawai', 'Affiliation': 'Department of Cardiology, Chikamori Hospital.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Cardiology, Saiseikai Kumamoto Hospital.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University Hospital.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Igarashi Hanaoka', 'Affiliation': 'Hanaoka Seishu Memorial Cardiovascular Clinic.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Department of Cardiology, Iwate Medical University Hospital.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Department of Cardiology, Teikyo University Hospital.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Kadota', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0298']
1347,32629091,Early-onset pneumonia following bag-mask ventilation versus endotracheal intubation during cardiopulmonary resuscitation: A substudy of the CAAM trial.,"AIM


Early-onset pneumonia (EOP) is a common in-hospital complication in survivors of out-of-hospital cardiac arrest. In this substudy of the CAAM trial, we aimed to compare whether bag mask ventilation (BMV) compared to endotracheal intubation (ETI) performed during cardiopulmonary resuscitation increases the risk of developing EOP.
METHODS


Adult patients from the CAAM trial that survived beyond 12 h of hospitalization were included. Information about in-hospital management and outcome of study subjects was systematically collected. Our primary aim was to compare the incidence of EOP in the BMV and ETI group using a series of bivariate analysis adjusting for one variable at a time and a logistic regression controlled for survival beyond 96 h, age, gender, catecholamine administration, no flow time, and initial shockable rhythm.
RESULTS


Of 627 patients from the CAAM trial that survived to hospital admission, 409 patients were hospitalized beyond 12 h and thus included (202 randomized to BMV and 20 7 randomized to ETI). Patients in the BMV group had a significantly longer period of unsecured airway during prehospital cardiopulmonary resuscitation (BMV (median): 33 min; ETI (median): 17 min, p < 0.0001). No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7-1.5], p = 1.0). We found no difference in the development of EOP according to airway management in the series of bivariate analyses or in the multivariable regression analysis either.
CONCLUSION


In this substudy of the CAAM trial, development of early-onset pneumonia in out-of-hospital cardiac arrest survivors did not depend on airway management technique during CPR.",2020,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","['cardiopulmonary resuscitation', 'Adult patients from the CAAM trial that survived beyond 12\u2009hours of hospitalization were included', '627 patients from the CAAM trial that survived to hospital admission', '409 patients were hospitalized beyond 12\u2009hours and thus included (202 randomized to BMV and 20 7 randomized to ETI']","['endotracheal intubation (ETI', 'bag-mask ventilation versus endotracheal intubation', 'bag mask ventilation (BMV']","['development of EOP according to airway management', 'risk of developing EOP', 'incidence of EOP']","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",627.0,0.0603892,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","[{'ForeName': 'Josefine S', 'Initials': 'JS', 'LastName': 'Baekgaard', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark; Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France. Electronic address: josefine.stokholm.baekgaard.01@regionh.dk.'}, {'ForeName': 'Mohamed N', 'Initials': 'MN', 'LastName': 'Triba', 'Affiliation': ""Sorbonne Paris Cité, Equipe Nanomédecine Biomarqueurs Détection, Laboratoire de Chimie, Structures et Propriétés de Biomateriaux et d'Agents Therapeutiques, UMR CNRS 7244, University Paris 13 Bobigny, France.""}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Brandeis', 'Affiliation': 'Service des Urgences, Hopital Ballanger, 93600 Aulnays, France.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Cohen', 'Affiliation': 'Intensive Care Unit, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gorlicki', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Deltour', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}]",Resuscitation,['10.1016/j.resuscitation.2020.06.011']
1348,32630191,Acute Effects of Lixisenatide on Energy Intake in Healthy Subjects and Patients with Type 2 Diabetes: Relationship to Gastric Emptying and Intragastric Distribution.,"Glucagon-like peptide-1 receptor agonists induce weight loss, which has been suggested to relate to the slowing of gastric emptying (GE). In health, energy intake (EI) is more strongly related to the content of the distal, than the total, stomach. We evaluated the effects of lixisenatide on GE, intragastric distribution, and subsequent EI in 15 healthy participants and 15 patients with type 2 diabetes (T2D). Participants ingested a 75-g glucose drink on two separate occasions, 30 min after lixisenatide (10 mcg) or placebo subcutaneously, in a randomised, double-blind, crossover design. GE and intragastric distribution were measured for 180 min followed by a buffet-style meal, where EI was quantified. Relationships of EI with total, proximal, and distal stomach content were assessed. In both groups, lixisenatide slowed GE markedly, with increased retention in both the proximal ( p  < 0.001) and distal ( p  < 0.001) stomach and decreased EI ( p  < 0.001). EI was not related to the content of the total or proximal stomach but inversely related to the distal stomach at 180 min in health on placebo ( r  = -0.58,  p =  0.03) but not in T2D nor after lixisenatide in either group. In healthy and T2D participants, the reduction in EI by lixisenatide is unrelated to changes in GE/intragastric distribution, consistent with a centrally mediated effect.",2020,"In both groups, lixisenatide slowed GE markedly, with increased retention in both the proximal ( p  < 0.001) and distal ( p  < 0.001) stomach and decreased EI ( p  < 0.001).","['Healthy Subjects and Patients with Type 2 Diabetes', '15 healthy participants and 15 patients with type 2 diabetes (T2D']","['lixisenatide', '75-g glucose drink', 'Lixisenatide', 'placebo']","['Energy Intake', 'GE and intragastric distribution', 'weight loss', 'Relationships of EI with total, proximal, and distal stomach content', 'distal stomach', 'content of the total or proximal stomach']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0038352', 'cui_str': 'Gastric contents'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1267582', 'cui_str': 'Proximal stomach structure'}]",15.0,0.0659903,"In both groups, lixisenatide slowed GE markedly, with increased retention in both the proximal ( p  < 0.001) and distal ( p  < 0.001) stomach and decreased EI ( p  < 0.001).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jalleh', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Hung', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Chinmay S', 'Initials': 'CS', 'LastName': 'Marathe', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Madeline D', 'Initials': 'MD', 'LastName': 'Buttfield', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide SA 5001, Australia.'}, {'ForeName': 'Seva', 'Initials': 'S', 'LastName': 'Hatzinikolas', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Malbert', 'Affiliation': 'Aniscan, Institut National de la Rechercher Agronomique, 35590 Saint-Gilles, France.'}, {'ForeName': 'Rachael S', 'Initials': 'RS', 'LastName': 'Rigda', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Laurence G', 'Initials': 'LG', 'LastName': 'Trahair', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}]",Nutrients,['10.3390/nu12071962']
1349,32630629,The Migration Pattern of a Cementless Hydroxyapatite-Coated Titanium Stem under Immediate Full Weight-Bearing-A Randomized Controlled Trial Using Model-Based RSA.,"(1) Background: High primary stability is important for the long-term survival of cementless femoral stems in total hip arthroplasty (THA). The objective of this study was to investigate the migration pattern of a hydroxyapatite-coated cementless hip stem developed for minimally invasive surgery using model-based radiostereometric analysis (RSA). (2) Methods: In this randomized controlled trial, 44 patients with an indication for cementless primary THA were randomly allocated to receive either the SL-PLUS MIA stem, developed for minimally invasive surgery, or the SL-PLUS stem (Smith & Nephew Orthopaedics, Baar, Switzerland) which served as a control group. Unlimited weight-bearing was permitted postoperatively in both groups. Model-based RSA was performed after six weeks and after 3, 6, 12 and 24 months postoperatively. (3) Results: Mean total stem subsidence at two-year follow-up was 0.40 mm (SD 0.66 mm) in the SL-PLUS group and 1.08 mm (SD 0.93 mm) in the SL-PLUS MIA group ( p  = 0.030). Stem subsidence occurred during the first six weeks after surgery, indicating initial settling of the stem under full weight-bearing. Both stem designs showed good osseointegration and high secondary stability with no further migration after initial settling. (4) Conclusions: Settling of a cementless straight femoral stem occurs during the first six weeks after surgery under full weight-bearing. Although initial stem migration was higher in the SL-PLUS MIA group, it had no influence on secondary stability. All implants showed good osseointegration and high secondary stability with no signs of implant loosening during this two-year follow-up period.",2020,All implants showed good osseointegration and high secondary stability with no signs of implant loosening during this two-year follow-up period.,"['total hip arthroplasty (THA', '44 patients with an indication for cementless primary THA']","['hydroxyapatite-coated cementless hip stem', 'SL-PLUS MIA stem, developed for minimally invasive surgery, or the SL-PLUS stem (Smith & Nephew Orthopaedics, Baar, Switzerland) which served as a control group', 'minimally invasive surgery using model-based radiostereometric analysis (RSA', 'Cementless Hydroxyapatite-Coated Titanium Stem']","['Mean total stem subsidence', 'Stem subsidence', 'good osseointegration and high secondary stability with no signs of implant loosening', 'secondary stability']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0337579', 'cui_str': 'Nephew'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0079949', 'cui_str': 'Osseointegration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}]",44.0,0.120705,All implants showed good osseointegration and high secondary stability with no signs of implant loosening during this two-year follow-up period.,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Reiner', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sonntag', 'Affiliation': 'Laboratory of Biomechanics and Implant Research, Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstr. 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Jan Philippe', 'Initials': 'JP', 'LastName': 'Kretzer', 'Affiliation': 'Laboratory of Biomechanics and Implant Research, Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstr. 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clarius', 'Affiliation': 'Department for Orthopedics and Traumatology, Vulpius Klinik GmbH, Vulpiusstrasse 29, 74906 Bad Rappenau, Germany.'}, {'ForeName': 'Eike', 'Initials': 'E', 'LastName': 'Jakubowitz', 'Affiliation': 'Laboratory for Biomechanics and Biomaterials, Department of Orthopaedic Surgery, Hannover Medical School, Anna-von-Borries-Str. 1-7, 30625 Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Weiss', 'Affiliation': 'ARCUS Clinics Pforzheim, Rastatter Str. 17-19, 75179 Pforzheim, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Ewerbeck', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Merle', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moradi', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kinkel', 'Affiliation': 'ARCUS Clinics Pforzheim, Rastatter Str. 17-19, 75179 Pforzheim, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gotterbarm', 'Affiliation': 'Department for Orthopedics and Traumatology, Kepler University Hospital GmbH, Johannes Kepler University Linz, Krankenhausstrasse 9, 4020 Linz and Altenberger Strasse 69, 4040 Linz, Austria.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Hagmann', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9072077']
1350,32632364,Videogame intervention to encourage HIV testing and counseling among adolescents.,"Background


Adolescents in the United States account for one-fifth of new HIV cases, and have the highest rate of undiagnosed HIV, with more than half (51%) not knowing their status. It is a crucial public health concern to help equip youth with the information and autonomy to minimize their risk and know their status. Serious videogames are emerging as valuable tools for health and behavior change in adolescents, and have potential to engage this population and increase their use of HIV testing and counseling (HTC). The purpose of this study was to: (I) modify an original serious game targeting risk reduction and HIV prevention developed by the play2PREVENT Lab and create a new serious game that focuses on HTC; (II) evaluate its feasibility and acceptability; (III) pilot-test the assessment measures that are subsequently being used in a large randomized controlled trial.
Methods


Three focus groups with adolescents, aged 14-17 (n=13, mean age =15), informed artwork and storylines for  PlayTest!  After the game was completed, a pilot test was conducted using a one-group pretest-posttest design to collect data on: (I) participants' gameplay satisfaction and experience; (II) the validity of the project's assessments. Twenty-six participants, aged 15-16 were enrolled from a local after-school program. Participants played  PlayTest!  twice weekly for three weeks. Data were collected on behavior, intentions, knowledge, perceived susceptibility, and attitudes related to HTC at baseline, post-gameplay (three weeks), and follow-up (six weeks).
Results


For the focus groups used in the game development, four major themes emerged: (I) adolescents have strong misperceptions about HTC, including who should get tested and what the test entails; (II) adolescents have incorrect knowledge about how HIV is contracted, spread, and treated; (III) adolescents are supportive of their peers getting tested for HIV, but are not likely to get tested themselves; (IV) while the majority of adolescents know where to get tested for HIV, social stigma, misperceptions around HTC, and fear of having a positive diagnosis keep them from seeking it. For the pilot study, overall, participant experience with the game was highly favorable. The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up.
Conclusions


The  PlayTest!  game provides promising results regarding using an engaging and evidence-informed videogame intervention to promote HTC in adolescents.",2020,"The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up.
","['groups with adolescents, aged 14-17 (n=13, mean age =15), informed artwork and storylines for  PlayTest', 'Twenty-six participants, aged 15-16 were enrolled from a local after-school program', 'adolescents', 'Participants played  PlayTest']",['Videogame intervention'],"['behavior, intentions, knowledge, perceived susceptibility, and attitudes related to HTC']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",26.0,0.0406421,"The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up.
","[{'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Pendergrass', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hieftje', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Duncan', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Fiellin', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}]",mHealth,['10.21037/mhealth.2020.01.05']
1351,32634485,Virtual mind-body treatment for adolescents with neurofibromatosis: Study protocol for a single-blind randomized controlled trial.,"BACKGROUND


Neurofibromatoses (NF) are a group of genetically distinct disorders of the nervous system unified by the predisposition to nerve sheath tumors. Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs. This paper presents the study design and protocol for the first randomized controlled trial (RCT) of a mind-body intervention for adolescents with NF, Resilient Youth with NF (RY-NF), versus an educational control group, Health Education for NF (HE-NF), both delivered in groups via secure live video.
METHODS


This is an ongoing, single-blind efficacy RCT. Recruitment began in November 2019 and will continue until March 2022. We will enroll 200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms. We will use a shared-baseline, linear mixed model to compare the effect of RY-NF versus HE-NF on changes in quality of life (QoL) and psychosocial outcomes from baseline to post-intervention, and 6- and 12-month follow-ups. We will also develop NF-specific minimal clinically important difference (MCID) for QoL variables, and conduct mediation and moderation analyses to understand mechanisms of improvement.
DISCUSSION


This study has important clinical and public health implications for the psychosocial functioning of adolescents with NF. It provides a model for efficient delivery of virtual psychosocial care for adolescents with rare diseases. Plans for dissemination and implementation of the RY-NF should efficacy be ascertained are also discussed.",2020,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","['adolescents with NF, Resilient Youth with NF (RY-NF', 'adolescents with neurofibromatosis', 'adolescents with NF', 'adolescents with rare diseases', '200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms']","['educational control group, Health Education for NF (HE-NF', 'Virtual mind-body treatment', 'mind-body intervention', 'RY-NF versus HE-NF']",['quality of life (QoL) and psychosocial outcomes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0678236', 'cui_str': 'Rare Diseases'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0582154', 'cui_str': 'Difficulty coping'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0666435,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Reichman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: mreichman@mgh.harvard.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Riklin', 'Affiliation': 'Department of Psychology, Fordham University, Dealy 336, 441 East Fordham Rd, Bronx, NY 10458, United States of America. Electronic address: eriklin@fordham.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, 50 Staniford Street, St 560, Boston, MA 02114, United States of America. Electronic address: emacklin@mgh.harvard.edu.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America; Harvard Medical School, One Bowdoin Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: avranceanu@mgh.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106078']
1352,32637860,Endometrial preparation using gonadotropin-releasing hormone agonist prior to frozen-thawed embryo transfer in women with repeated implantation failure: An RCT.,"Background


Preparation of endometrial thickness in frozen-thawed embryo transfer (FET) is extremely important, particularly in repeated implantation failure (RIF) patients.
Objective


This study aimed to investigate the clinical outcomes of FET cycles among RIF women, based on the effects of administering gonadotropin-releasing hormone (GnRH) agonist prior to estrogen-progesterone preparation of the endometrium.
Materials and Methods


In this randomized clinical trial, 67 infertile women who were candidates for FET were divided into two groups: A) case group (n = 34), treated with GnRH agonist prior to endometrial preparation and B) control group (n = 33), which received the routine protocol. (6 mg daily estradiol started from second day) The clinical outcomes) including chemical and clinical pregnancy, in addition to implantation rates, were compared between the two groups.
Results


The results showed no significant differences in women's age (p = 0.558), duration (p = 0.540), type (p = 0.562), and cause of infertility (p = 0.699). Regarding pregnancy and implantation rates, there was a trend toward an increase in the case group; however, differences were not statistically significant.
Conclusion


Although our results showed no significant differences between groups. Because there are trends to better results in case group larger sample size may show significant difference.",2020,"The results showed no significant differences in women's age (p = 0.558), duration (p = 0.540), type (p = 0.562), and cause of infertility (p = 0.699).","['women with repeated implantation failure', '67 infertile women who were candidates for FET', 'repeated implantation failure (RIF) patients', 'RIF women']","['GnRH agonist prior to endometrial preparation and B) control group', 'gonadotropin-releasing hormone agonist prior to frozen-thawed embryo transfer', 'gonadotropin-releasing hormone (GnRH) agonist prior to estrogen-progesterone', 'frozen-thawed embryo transfer (FET']","['pregnancy and implantation rates', 'chemical and clinical pregnancy, in addition to implantation rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}]",67.0,0.0825234,"The results showed no significant differences in women's age (p = 0.558), duration (p = 0.540), type (p = 0.562), and cause of infertility (p = 0.699).","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Dashti', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Omidi', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i5.7150']
1353,32638545,Percutaneous Vertebroplasty with Side-Opening Cannula or Front-Opening Cannula in the Treatment of Kummell Disease?,"OBJECTIVE


To explore the effect of bone cement distribution, cement leakage, and clinical outcomes with side-opening cannula for bone cement injection in percutaneous vertebroplasty (PVP) in treatment of Kummell disease.
METHODS


A prospective study of patients with Kummell disease undergoing PVP was conducted from April 2012 to September 2017. In total, 43 patients (11 males, 32 females) with Kummell disease who received bilateral PVP were included in the study. The patients were divided into front-opening cannulas (FOC) group with front-opening cannulas and side-opening cannulas (SOC) group with side-opening cannulas. All patients were followed up for 6 months. The patient general information such as gender, age, bone density, compression ratio, operative time, and location of fracture vertebrae were recorded. Visual analogue scale (VAS), Oswestry Disability Index (ODI), bone cement distribution, radiation exposure time, bone cement leakage rate and vertebral height, and kyphosis angle were measured and compared for two groups before surgery, 1 day and 6 months after surgery.
RESULTS


A total of 43 patients were enrolled, including 11 males and 32 females, aged 61-84 years. The bone density (T value) was 2.5 ± 0.6 in FOC group and 2.4 ± 0.6 in SOC group (P > 0.05). The compression ratio and operative time were 36.1% ± 13.0%, 39.3 ± 7.9 min in FOC group and 35.2% ± 13.7%, 40.0 ± 10.7 min in SOC group (P > 0.05). There was no significance between FOC and SOC groups in the location of fracture vertebrae. All patients underwent at least 6 months of follow-up. At 6 months postoperatively, the VAS and ODI were significantly higher in the FOC group (3.0 ± 0.8, 35.7% ± 2.1%) than in the SOC group (1.3 ± 0.4, 18.6% ± 2.4%) (P < 0.05). The cement leakage rate of the SOC group was 4.8%, which was lower than that of the FOC group (31.8%, P < 0.05), and the bone cement distribution ratio was higher than that of the FOC group (63.1% ± 7.9% vs 40.5% ± 8.6%, P < 0.05). At 6 months after operation, the height of the anterior and posterior vertebral bodies of the patients in the SOC group restored better than the FOC group (anterior SOC: FOC 5.1 ± 0.5 mm vs 4.5 ± 0.5 mm; posterior SOC: FOC 0.6 ± 0.1 mm vs 0.3 ± 0.1 mm, P < 0.05), and the kyphosis correction was more obvious than patients in FOC group (SOC: FOC 8.5° ± 1.4° vs 4.6° ± 0.8°, P < 0.05).
CONCLUSION


Percutaneous vertebroplasty with side-opening cannula is safe and effective in avoiding bone cement leakage, improving bone cement distribution, and restoring vertebral height.",2020,"Percutaneous vertebroplasty with side-opening cannula is safe and effective in avoiding bone cement leakage, improving bone cement distribution, and restoring vertebral height.","['43 patients (11 males, 32 females) with Kummell disease who received bilateral PVP were included in the study', '43 patients were enrolled, including 11 males and 32 females, aged 61-84\u2009years', 'patients with Kummell disease undergoing PVP was conducted from April 2012 to September 2017']","['FOC', 'front-opening cannulas (FOC) group with front-opening cannulas and side-opening cannulas (SOC) group with side-opening cannulas', 'percutaneous vertebroplasty (PVP', 'Percutaneous vertebroplasty with side-opening cannula', 'side-opening cannula', 'Percutaneous Vertebroplasty with Side-Opening Cannula or Front-Opening Cannula']","['compression ratio and operative time', 'VAS and ODI', 'Visual analogue scale (VAS), Oswestry Disability Index (ODI), bone cement distribution, radiation exposure time, bone cement leakage rate and vertebral height, and kyphosis angle', 'height of the anterior and posterior vertebral bodies', 'bone cement distribution ratio', 'bone density (T value', 'bone density, compression ratio, operative time, and location of fracture vertebrae', 'kyphosis correction', 'cement leakage rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152088', 'cui_str': 'Traumatic spondylopathy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]",43.0,0.0197373,"Percutaneous vertebroplasty with side-opening cannula is safe and effective in avoiding bone cement leakage, improving bone cement distribution, and restoring vertebral height.","[{'ForeName': 'Xi-Fa', 'Initials': 'XF', 'LastName': 'Wu', 'Affiliation': 'Department of Spinal Surgery, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ping', 'Affiliation': 'Department of Orthopaedics, Rizhao Central Hospital, Rizhao, China.'}, {'ForeName': 'Xiang-Qin', 'Initials': 'XQ', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiology, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopaedics, Chongqing University Central Hospital, Chongqing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Spinal Surgery, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Spinal Surgery, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Dong-Jin', 'Initials': 'DJ', 'LastName': 'Wu', 'Affiliation': 'Department of Spinal Surgery, The Second Hospital of Shandong University, Jinan, China.'}]",Orthopaedic surgery,['10.1111/os.12730']
1354,32640940,Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Delayed cerebral ischemia (DCI) is the most important cause for a poor clinical outcome after a subarachnoid hemorrhage. The aim of this study was to assess whether goal-directed hemodynamic therapy (GDHT), as compared to standard clinical care, reduces the rate of DCI after subarachnoid hemorrhage.
METHODS


We conducted a prospective randomized controlled trial. Patients >18 years of age with an aneurysmal subarachnoid hemorrhage were enrolled and randomly assigned to standard therapy or GDHT. Advanced hemodynamic monitoring and predefined GDHT algorithms were applied in the GDHT group. The primary end point was the occurrence of DCI. Functional outcome was assessed using the Glasgow Outcome Scale (GOS) 3 months after discharge.
RESULTS


In total, 108 patients were randomized to the control (n=54) or GDHT group (n=54). The primary outcome (DCI) occurred in 13% of the GDHT group and in 32% of the control group patients (odds ratio, 0.324 [95% CI, 0.11-0.86];  P =0.021). Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02). The GOS was assessed 3 months after discharge in 107 patients; it showed more patients with a low disability (GOS 5, minor or no deficits) than patients with higher deficits (GOS 1-4) in the GDHT group compared with the control group (GOS 5, 66% versus 44%; GOS 1-4, 34% versus 56%;  P =0.025). There was no significant difference in mortality between the groups.
CONCLUSIONS


GDHT reduced the rate of DCI after subarachnoid hemorrhage with a better functional outcome (GOS=5) 3 months after discharge. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01832389.",2020,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02).","['108 patients', 'After Aneurysmal Subarachnoid Hemorrhage', 'Patients >18 years of age with an aneurysmal subarachnoid hemorrhage']","['standard therapy or GDHT', 'GDHT', 'goal-directed hemodynamic therapy (GDHT', 'Goal-Directed Therapy']","['rate of DCI after subarachnoid hemorrhage', 'GOS', 'Glasgow Outcome Scale (GOS', 'occurrence of DCI', 'mortality', 'Delayed Ischemia']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",108.0,0.182296,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02).","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Anetsberger', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ringel', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bogdanski', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heim', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Ryang', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wostrack', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029279']
1355,32643163,Effects of a standardized community health worker intervention on hospitalization among disadvantaged patients with multiple chronic conditions: A pooled analysis of three clinical trials.,"OBJECTIVE


To analyze the effects of a standardized community health worker (CHW) intervention on hospitalization.
DATA SOURCES/STUDY SETTING


Pooled data from three randomized clinical trials (n = 1340) conducted between 2011 and 2016.
STUDY DESIGN


The trials in this pooled analysis were conducted across diseases and settings, with a common study design, intervention, and outcome measures. Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured. They were randomly assigned to receive usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation. Trial one (n = 446) tested two weeks of IMPaCT among hospitalized general medical patients. Trial two (n = 302) tested six months of IMPaCT among outpatients at two academic primary care clinics. Trial three (n = 592) tested six months of IMPaCT among outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices.
DATA COLLECTION/EXTRACTION METHODS


The primary outcome for this study was all-cause hospitalization, as measured by total number of hospital days per patient. Hospitalization data were collected from statewide or VA databases at 30 days postenrollment in Trial 1, twelve months postenrollment in Trial 2, and nine months postenrollment in Trial 3.
PRINCIPAL FINDINGS


Over 9398 observed patient months, the total number of hospital days per patient in the intervention group was 66 percent of the total in the control group (849 days for 674 intervention patients vs 1258 days for 660 control patients, incidence rate ratio (IRR) 0.66, P < .0001). This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03). The intervention also decreased rates of hospitalization outside patients' primary health system (18.8 percent vs 34.8 percent, P = .0023).
CONCLUSIONS


Data from three randomized clinical trials across multiple settings show that a standardized CHW intervention reduced total hospital days and hospitalizations outside the primary health system. This is the largest analysis of randomized trials to demonstrate reductions in hospitalization with a health system-based social intervention.",2020,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","['Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured', 'outpatients at two academic primary care clinics', 'hospitalized general medical patients', 'outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices', 'Pooled data from three randomized clinical trials (n\xa0', 'disadvantaged patients with multiple chronic conditions', '1340) conducted between 2011 and 2016']","['standardized community health worker intervention', 'standardized CHW intervention', 'usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation', 'standardized community health worker (CHW) intervention']","['incidence rate ratio', 'total hospital days and hospitalizations', ""rates of hospitalization outside patients' primary health system"", 'total number of hospital days per patient', 'shorter mean length of stay', 'cause hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.281442,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Vasan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Morgan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mitra', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Kangovi', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Health services research,['10.1111/1475-6773.13321']
1356,32645109,"A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan.","BACKGROUND


Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
METHODS AND FINDINGS


A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints.
CONCLUSIONS


Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230).
TRIAL REGISTRATION


The trial is registered at ISRCTN, trial number ISRCTN30393230.",2020,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","['children aged 6-59 months', 'in Kenya and South Sudan', 'acute malnutrition in children 6-59 months (ComPAS trial', 'From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male', 'Kenya and South Sudan']","['combined protocol against standard care', 'SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF']","['cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains', 'nutritional recovery']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C3273373', 'cui_str': 'South Sudan'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517590', 'cui_str': '16.7'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}]",2071.0,0.180003,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lelijveld', 'Affiliation': 'No Wasted Lives, Action Against Hunger UK, London, United Kingdom.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Marron', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Onyo', 'Affiliation': 'Action Against Hunger, Juba, South Sudan.'}, {'ForeName': 'Eunice N', 'Initials': 'EN', 'LastName': 'Musyoki', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Adongo', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Department of International Health, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Kerac', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003192']
1357,32651013,Randomized Study of Delayed Cord Clamping of 30 to 60 Seconds in the Larger Infant Born Preterm.,"In a randomized study of infants born preterm (gestational age 28-34 6/7 weeks), we evaluated delayed cord clamping for 30 (n = 50) vs 60 (n = 55) seconds. The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds. There were no differences in secondary outcomes and no adverse consequences between groups. These findings should serve as a stimulus to many centers that are reluctant to implement delayed cord clamping in this targeted larger premature population.",2020,"The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds.","['Larger Infant Born Preterm', 'infants born preterm (gestational age 28-34 6/7\xa0weeks), we evaluated delayed cord clamping for 30 (n\xa0=\xa050) vs 60 (n\xa0=\xa055) seconds']",['Delayed Cord Clamping'],"['adverse consequences', 'initial hematocrit']","[{'cui': 'C0349482', 'cui_str': 'High birth weight'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]",,0.0611567,"The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Perretta', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Spaight', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Yap', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Perlman', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY. Electronic address: jmp2007@med.cornell.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.058']
1358,32651030,"Effects of an integrative approach to bipolar disorders combining psychoeducation, mindfulness-based cognitive therapy and functional remediation: Study protocol for a randomized controlled trial.","INTRODUCTION


Bipolar disorder is related to a high level of personal, familial, social and economic burden. There is a need for feasible adjunctive psychological interventions easy to implement in clinical practice in order to enhance aspects that medication alone cannot achieve. This study aims to evaluate the impact of a 12-session adjunctive integrative program designed for patients with bipolar disorder.
METHODS


This is a single-blind prospective, randomized controlled trial involving a total of 132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona. All participants will be randomly assigned to two arms. All the patients will receive treatment as usual (TAU) but in addition the experimental group will receive an integrative approach consisting of 12-sessions of 90min each in which contents of psychoeducation for patients have been combined with a session for family members, and complemented with aspects related to health promotion, mindfulness training, and strategies for cognitive and functional enhancement. The whole sample will be assessed at baseline, after completion (3-months) and at 12 months from baseline regarding demographic and clinical variables, psychosocial and cognitive functioning, wellbeing and quality of life. The primary outcome measure will be improvement in psychosocial functioning.
CONCLUSIONS


If the integrative approach is effective, it would allow clinicians to cover different areas that may be affected by bipolar disorder, by means of a brief intervention that can therefore be easily generalized to clinical practice.
TRIAL REGISTRATION


NCT04031560. Date registered July 24, 2019.",2020,"This is a single-blind prospective, randomized controlled trial involving a total of 132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona.","['132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona', 'patients with bipolar disorder']","['integrative approach to bipolar disorders combining psychoeducation, mindfulness-based cognitive therapy']","['psychosocial functioning', 'demographic and clinical variables, psychosocial and cognitive functioning, wellbeing and quality of life']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",132.0,0.145927,"This is a single-blind prospective, randomized controlled trial involving a total of 132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona.","[{'ForeName': 'Èlia', 'Initials': 'È', 'LastName': 'Valls', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sánchez-Moreno', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain. Electronic address: JSANCHE1@clinic.cat.'}, {'ForeName': 'C Mar', 'Initials': 'CM', 'LastName': 'Bonnín', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Brisa', 'Initials': 'B', 'LastName': 'Solé', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Prime-Tous', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Torres', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Brat', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gavin', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ivette', 'Initials': 'I', 'LastName': 'Morilla', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Montejo', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jiménez', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Varo', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Torrent', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Hidalgo-Mazzei', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Martínez-Arán', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain. Electronic address: AMARTIAR@clinic.cat.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Reinares', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}]",Revista de psiquiatria y salud mental,['10.1016/j.rpsm.2020.05.005']
1359,32664282,"Changes in Metabolites During an Oral Glucose Tolerance Test in Early and Mid-Pregnancy: Findings from the PEARLS Randomized, Controlled Lifestyle Trial.","The oral glucose tolerance test (OGTT) is used to diagnose gestational and other types of diabetes. We examined metabolite changes during an OGTT, and how a comprehensive diet and physical activity intervention may influence these changes in a population of overweight/obese Hispanic pregnant women. Integration of changes in metabolites during an OGTT may help us gain preliminary insights into how glucose metabolism changes during pregnancy. Among women from the Pregnancy and EARly Lifestyle improvement Study (PEARLS), we measured metabolites during a multipoint OGTT (fasting, 30, 60 and 120 min) at early and mid-pregnancy. Metabolite levels were measured by liquid chromatography-mass spectrometry in plasma samples in the lifestyle intervention ( n  = 13) and control ( n  = 16) arms of the study. A total of 65 candidate metabolites were selected that displayed changes during an OGTT in previous studies. Paired and unpaired  t -tests were used to examine differences in Δfast-120 min: (1) at early and mid-pregnancy; and (2) by intervention assignment. We applied principal component analysis (PCA) to identify those metabolites that differed by intervention assignment and OGTT time points. Most of the characteristic changes in metabolites post-OGTT were similar at both gestational time points. PCA identified characteristic metabolite patterns associated with OGTT time points at both early and mid-pregnancy. These metabolites included ketone bodies, tryptophan, acyl carnitines, polyunsaturated fatty acids, and biomarkers related to bile acid, urea cycle, arginine, and proline metabolism. PCA identified distinct Δfast-120 min in fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels at mid- compared to early pregnancy. Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group. These findings provide preliminary insight into metabolites, whose role in increased insulin resistance during pregnancy, should be explored further in future studies.",2020,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"['population of overweight/obese Hispanic pregnant women', 'Early and Mid-Pregnancy']",['comprehensive diet and physical activity intervention'],"['Metabolite levels', 'fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels', 'oral glucose tolerance test (OGTT']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.0276949,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Haslam', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Marijulie', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Center for Clinical Research and Health Promotion, University of Puerto Rico Medical Sciences Campus, San Juan, PR 00936-5067, Puerto Rico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12, SE-214 28 Malmö, Sweden.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Shilpa N', 'Initials': 'SN', 'LastName': 'Bhupathiraju', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}]",Metabolites,['10.3390/metabo10070284']
1360,32664289,"Effects of PrObiotics on the Symptoms and Surgical ouTComes after Anterior REsection of Colon Cancer (POSTCARE): A Randomized, Double-Blind, Placebo-Controlled Trial.","We investigated microbiota changes following surgical colon cancer resection and evaluate effects of probiotics on microbiota and surgical recovery. This randomized double-blind trial was performed at four medical centers in South Korea. Of 68 patients expected to undergo anterior sigmoid colon cancer resection, 60 were eligible, of whom 29 and 31 received probiotics and placebo, respectively, for four weeks, starting at one week preoperatively. Third- and/or fourth-week information on anterior resection syndrome (ARS), inflammatory markers, and quality of life was obtained. Stool sample analysis was conducted after randomization and bowel preparation and at three and four postoperative weeks. Bacteria were categorized into Set I (with probiotic effects) and II (colon cancer-associated). The probiotic group's ARS score showed an improving trend ( p =  0.063), particularly for flatus control ( p =  0.030). Serum zonulin levels significantly decreased with probiotics. Probiotic ingestion resulted in compositional changes in gut microbiota; greater increases and decreases in Set I and II bacteria, respectively, occurred with probiotics. Compositional increase in Set I bacteria was associated with reduced white blood cells, neutrophils, neutrophil-lymphocyte ratio, and zonulin.  Bifidobacterium  composition was negatively correlated with zonulin levels in the probiotic group. Probiotics improved postoperative flatus control and modified postoperative changes in microbiota and inflammatory markers.",2020,"Probiotic ingestion resulted in compositional changes in gut microbiota; greater increases and decreases in Set I and II bacteria, respectively, occurred with probiotics.","['68 patients expected to undergo anterior sigmoid colon cancer resection, 60 were eligible, of whom 29 and 31 received', 'after Anterior REsection of Colon Cancer (POSTCARE', 'four medical centers in South Korea']","['Placebo', 'Probiotic ingestion', 'surgical colon cancer resection', 'PrObiotics', 'probiotics', 'probiotics and placebo']","['postoperative flatus control and modified postoperative changes in microbiota and inflammatory markers', 'zonulin levels', 'white blood cells, neutrophils, neutrophil-lymphocyte ratio, and zonulin', 'anterior resection syndrome (ARS), inflammatory markers, and quality of life', 'Symptoms and Surgical ouTComes', 'Serum zonulin levels', 'Set I and II bacteria', 'microbiota and surgical recovery', 'Bifidobacterium  composition', 'ARS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",68.0,0.423716,"Probiotic ingestion resulted in compositional changes in gut microbiota; greater increases and decreases in Set I and II bacteria, respectively, occurred with probiotics.","[{'ForeName': 'In Ja', 'Initials': 'IJ', 'LastName': 'Park', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Centre and University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Ju-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Food Science and Biotechnology, Graduate School of Biotechnology, Kyung Hee University, 1732, Deogyeong-daero, Giheung-gu, Yongin-si, Gyeonggi-do 17104, Korea.'}, {'ForeName': 'Bong-Hyeon', 'Initials': 'BH', 'LastName': 'Kye', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do 16247, Korea.""}, {'ForeName': 'Heung-Kwon', 'Initials': 'HK', 'LastName': 'Oh', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, 300 Gumi-dong Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Korea.'}, {'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea.'}, {'ForeName': 'You-Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Biotechnology, Graduate School of Biotechnology, Kyung Hee University, 1732, Deogyeong-daero, Giheung-gu, Yongin-si, Gyeonggi-do 17104, Korea.'}, {'ForeName': 'Joo Yun', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'R&BD Centre, Korea Yakult Co. Ltd., 577, Gangnam-daero, Seocho-gu, Seoul 05505, Korea.'}, {'ForeName': 'Na Young', 'Initials': 'NY', 'LastName': 'Sung', 'Affiliation': 'National Cancer Control Institute, National Cancer Centre, 323 Ilsan-ro, Ilsandong-gu, Goyang-si Gyeonggi-do 10408, Korea.'}, {'ForeName': 'Sung-Bum', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, 300 Gumi-dong Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Korea.'}, {'ForeName': 'Jeong-Meen', 'Initials': 'JM', 'LastName': 'Seo', 'Affiliation': 'Division of Pediatric Surgery, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Ilwon-ro, Gangnam-gu, Seoul 06351, Korea.'}, {'ForeName': 'Jae-Hun', 'Initials': 'JH', 'LastName': 'Sim', 'Affiliation': 'R&BD Centre, Korea Yakult Co. Ltd., 577, Gangnam-daero, Seocho-gu, Seoul 05505, Korea.'}, {'ForeName': 'Jung-Lyoul', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'R&BD Centre, Korea Yakult Co. Ltd., 577, Gangnam-daero, Seocho-gu, Seoul 05505, Korea.'}, {'ForeName': 'In Kyu', 'Initials': 'IK', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Division of Colorectal Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea.""}]",Journal of clinical medicine,['10.3390/jcm9072181']
1361,32671536,"The first management using intubation of a nasogastric tube with Gastrografin enterography or long tube for non-strangulated acute small bowel obstruction: a multicenter, randomized controlled trial.","BACKGROUND


Gastrointestinal decompression is generally applied to a non-strangulated acute small bowel obstruction (NSASBO). Although long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G) have shown advantages over NGT alone in previous studies, no studies appear to have compared LT and NGT-G.
METHODS


In this multicenter, randomized controlled trial, patients with NSASBO were randomly assigned to receive LT or NGT-G between July 2016 and November 2018 at 11 Japanese institutions. The primary endpoint was non-inferiority of NGT-G compared to LT for non-surgery rate, and the lower limit of the 95% confidence interval for the non-surgery rate (-15%) was set as the lower margin for inferiority of NGT-G compared to LT.
RESULTS


In total, 223 patients (LT group, n = 111; NGT-G group, n = 112) were analyzed in the present trial. The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923). On the other hand, the non-surgery rate with pure NGT-G alone (76.8%) that represents non-cross-over NGT-G without subsequent LT was significantly lower than that with LT (P = 0.039). Median procedure time was significantly shorter with NGT-G (1 min) than with LT (25 min; P < 0.001), whereas no significant differences in mortality or hospital stay were noted between groups.
CONCLUSION


NGT-G is an effective alternative to LT as a first-line treatment for NSASBO. A sequential strategy comprising NGT-G followed by LT might offer a new standard for NSASBO.
CLINICAL TRIALS REGISTRATION


This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (umin.ac.jp/ctr Identifier: UMIN000022669) prior to the start of this trial.",2020,"The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923).","['between July 2016 and November 2018 at 11 Japanese institutions', '223 patients (LT group, n\u2009=\u2009111; NGT-G group, n\u2009=\u2009112', 'patients with NSASBO', 'for non-strangulated acute small bowel obstruction']","['nasogastric tube with Gastrografin enterography or long tube', 'LT or NGT-G', 'long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G', 'NGT-G']","['non-surgery rate', 'mortality or hospital stay', 'non-inferiority of NGT-G', 'Median procedure time']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205362', 'cui_str': 'Strangulated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction'}]","[{'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0733796', 'cui_str': 'Gastrografin'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",223.0,0.14338,"The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923).","[{'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Katano', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. tshimura@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Hirotada', 'Initials': 'H', 'LastName': 'Nishie', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Iwai', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Itoh', 'Affiliation': 'Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Ebi', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Togawa', 'Affiliation': 'Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, 5-161 Maehata, Tajimi, 507-8522, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Gastroenterology, Gamagori City Hospital, 1-1 Mukaida, Hirata-cho, Gamagori, 443-8501, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nojiri', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sugiura', 'Affiliation': 'Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Matoya', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Nagura', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Koguchi', 'Affiliation': 'Department of Gastroenterology, Chukyo Hospital, 1-1-10 Sanjyo, Minami-ku, Nagoya, 457-8510, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ono', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Ozeki', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kataoka', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-020-01708-5']
1362,32668666,"An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial.","The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow's milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF ( n  = 134) or IPF ( n  = 134) from ≤14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/-3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means -1.2 g/d; 90% CI (-2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula; it is also safe for use and well-tolerated in healthy term infants.",2020,"No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups.","['healthy term infants', ""intact cow's milk protein formula (IPF"", 'infants whose mothers intended to fully formula feed']","['partially hydrolyzed whey protein-based infant formula (PHF', 'PHF', 'IPF']","['recorded adverse events, growth and gastro-intestinal tolerance parameters', 'weight gain', 'growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes', 'safety and tolerance']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.262772,"No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups.","[{'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Picaud', 'Affiliation': 'Hospices Civils de Lyon; Neonatal Intensive Care Unit, Hôpital de la Croix Rousse, 69004 Lyon, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pajek', 'Affiliation': 'NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska, 41-103 Siemianowice-Slaskie, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Arciszewska', 'Affiliation': 'Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k, 15-435 Bialystok, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Tarczón', 'Affiliation': 'Specjalistyczna Poradnia Medyczna Przylądek Zdrowia, 31-589 Kraków, Poland.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Escribano', 'Affiliation': 'Hospital Universitari Sant Joan de Reus, 43204 Reus, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Porcel', 'Affiliation': 'Hospital Quirónsalud Barcelona, 08023 Barcelona, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Adelt', 'Affiliation': 'Paediatric Practice, 49565 Bramsche, Germany.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Hassink', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Rijnierse', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Abrahamse-Berkeveld', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Korczowski', 'Affiliation': 'Department of Pediatrics and Pediatric Gastroenterology, College of Medical Sciences, University of Rzeszów, 35-302 Rzeszów, Poland.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Tenuto Study Group', 'Affiliation': ''}]",Nutrients,['10.3390/nu12072072']
1363,32675483,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","['79 ileocolic CD patients', ""Crohn's Disease""]",['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis'],"['SR rate', 'severe postoperative ER', 'postoperative outcomes', 'clinical recurrence (CR', 'endoscopic recurrence (ER) ', 'reduced risk of ER', 'endoscopic recurrence score and surgical recurrence rate', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'surgical recurrence (SR', 'longer time until CR']","[{'cui': 'C0450203', 'cui_str': 'Ileocolic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic'}, {'cui': 'C0332856', 'cui_str': 'Anastomosis, side to side'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",79.0,0.161354,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
1364,32675536,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2020,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'absorbable or nonabsorbable mesh repair']","['chest pain, diarrhea, and bloat symptoms', 'clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}]","[{'cui': 'C0014857', 'cui_str': 'Repair of paraesophageal diaphragmatic hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0450093', 'cui_str': 'Very large'}, {'cui': 'C0376710', 'cui_str': 'Sliding hiatus hernia'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdominal bloating'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
1365,32675537,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 7.9 (95% confidence interval: 1.0-62.4)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2020,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'One hundred twenty-two patients received', '304 patients were randomized', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution', 'simple appendicitis (SA) in children']","['placebo', 'placebo or antibiotics (Abx', 'Laparoscopic Appendicectomy', 'laparoscopic appendicectomy']","['incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation', 'WI rates', 'postoperative length of stay in a hospital', 'intra-abdominal abscess']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",304.0,0.815373,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
1366,32675541,Evidence-based Reviews in Surgery Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: Five-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial).,"QUESTION


Does surgery or conservative management of recurring diverticulitis/ongoing symptoms results in a higher quality of life (QoL) at 5-year follow-up.
DESIGN


Randomized controlled trial.
SETTING


Multicenter trial in the Netherlands.
PATIENTS


Patients aged 18 to 75 years, who presented with either ongoing abdominal complaints (for >3 months) and/or frequently recurring left-sided diverticulitis (>2 episodes in 2 years) after an objectified (via Computed Tomography, Ultrasound or Endoscopy) episode of diverticulitis were included in this study.
INTERVENTION


Elective Sigmoid Resection within 6 weeks vs. Conservative Management MAIN OUTCOME:: QoL at 5-year follow-up, as measured by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes included additional QoL assessments (including the EuroQoL-5D-3L, Visual Analogue Score for pain, and the short form 36 health survey) RESULTS:: The intention to treat analysis showed the surgical group had a higher quality of life (GIQLI) score than the conservative group (mean difference 9.7, 95% confidence interval 1.7-17.7, P = 0.018), which approached but did not meet the minimum important difference of 10. This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
CONCLUSIONS


The study results demonstrate that HRQOL at 5-year follow-up may be improved in patients undergoing surgical resection, although this difference did not meet the MID for the GIQLI.",2020,"This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
","['patients undergoing surgical resection', 'Patients aged 18 to 75 years, who presented with either ongoing abdominal complaints (for >3 months) and/or frequently recurring left-sided diverticulitis (>2 episodes in 2 years) after an objectified (via Computed Tomography, Ultrasound or Endoscopy) episode of diverticulitis were included in this study', 'Multicenter trial in the Netherlands']","['Surgery Versus Conservative Management', 'Elective Sigmoid Resection']","['Gastrointestinal Quality of Life Index (GIQLI', 'additional QoL assessments (including the EuroQoL-5D-3L, Visual Analogue Score for pain, and the short form 36 health survey', 'higher quality of life (GIQLI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid colon structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.183572,"This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
","[{'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': ""Department of Surgery Queen's University, Kingston, Canada.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hendren', 'Affiliation': 'Department of Surgery University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zaborowski', 'Affiliation': ""Centre for Colorectal Disease St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Des', 'Initials': 'D', 'LastName': 'Winter', 'Affiliation': ""Centre for Colorectal Disease St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003920']
1367,32674351,The Use of Different Modes of Post-Activation Potentiation (PAP) for Enhancing Speed of the Slide-Step in Basketball Players.,"Background : This study aimed to determine whether 5% of body mass-resisted or assisted conditioning activity (CA) can enhance 5 m slide-step movement performance.  Methods : Sixteen division I basketball players participated in this study (23.6 ± 4.4 years; 86.3 ± 5.9 kg; 192.3 ± 6.2 cm; training experience 6.7 ± 2.6 years). The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols-assisted and resisted CA each consisting of four sets of 10 m slide-step movement with 5% of body mass external load and 1 min rest intervals between. To assess the differences between baseline and post-assisted, as well as post-resisted CA, the participants performed a 2 × 5 m slide-step movement 6 min after each CA protocol. The differences in time between baseline, post-assisted and post-resisted CA were examined using repeated-measures ANOVA.  Results : ANOVA indicated a statistically significant difference between baseline and post-assisted postactivation performance enhancement (PAPE) ( p  = 0.011). There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  Conclusion : Findings of the study show that a light load assisted CA (5% of body mass) effectively elicits a potentiation response among basketball players.",2020,There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  ,"['Sixteen division I basketball players participated in this study (23.6 ± 4.4 years; 86.3 ± 5.9 kg; 192.3 ± 6.2 cm; training experience 6.7 ± 2.6 years', 'Basketball Players']","[' ', 'body mass-resisted or assisted conditioning activity (CA', 'Different Modes of Post-Activation Potentiation (PAP', 'light load assisted CA']",['postactivation performance enhancement (PAPE'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]",,0.0797312,There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  ,"[{'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Golas', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Zajac', 'Affiliation': 'Human Performance Laboratory, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145057']
1368,32679281,"China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial.","Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. METHODS AND RESULTS: The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. CONCLUSIONS: Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.",2020,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","['patients with Acute Myocardial Infarction (CTS-AMI', '3,796 eligible patients with STEMI from about 120 centers']","['Tongxinluo (TXL', 'TXL', 'TXL or placebo', 'placebo']","['each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters', '30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1742872', 'cui_str': 'tongxinluo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0948369', 'cui_str': 'Myocardial reinfarction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",3796.0,0.355531,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Dou', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qiuting', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guangyuan', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guihao', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ruijie', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingang', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Peking University Clinical Research Institute, Peking University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: yangyjfw@126.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.011']
1369,32679370,Early application of caffeine improves white matter development in very preterm infants.,"The aim of this study was to evaluate the effect of early prophylactic caffeine treatment on white matter development in very preterm infants using cerebral magnetic resonance imaging. A total of 194 preterm infants (≤32 weeks gestational age) were randomly assigned to the caffeine (n = 96) or placebo (n = 93) treatment group and administered with either caffeine or placebo within 72 h after birth. Cerebral magnetic resonance imaging, including diffuse tensor imaging examination, was performed at 34-36 weeks of corrected gestational age, and the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were measured. In total, 160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group. There were fewer instances of apnea of prematurity and shorter assisted ventilation times for infants in the caffeine group compared to the placebo group (p < 0.05). Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group. ADC values in the above white matter areas were significantly reduced in the caffeine group. However, there were no significant differences regarding the FA and ADC in the gray matter between the two groups. These results demonstrate that early administration of caffeine improves white matter micro-structural development in preterm infants, but with no significant effect on short-term complications related to prematurity.",2020,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","['very preterm infants', 'very preterm infants using cerebral magnetic resonance imaging', 'preterm infants', '194 preterm infants (≤32 weeks gestational age', '160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group']","['placebo', 'caffeine', 'caffeine or placebo', 'prophylactic caffeine']","['white matter micro-structural development', 'apnea of prematurity and shorter assisted ventilation times', 'FA values', 'fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values', 'FA and ADC', 'ADC values']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",194.0,0.144528,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","[{'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Ruili', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Perinatal Medicine and Health, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden.'}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm 17177, Sweden. Electronic address: changlian.zhu@neuro.gu.se.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103495']
1370,32679400,Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study.,"OBJECTIVES


There is limited evidence available on the health-seeking behaviours of individuals in relation to determinants of healthcare use. This study aimed to analyse the determinants of healthcare use (including both hospital and outpatient services) among homeless people with severe mental health illnesses.
STUDY DESIGN


The study used data from a multicentre, randomised, controlled trial conducted in four large French cities (the French Housing First Study).
METHODS


Data were drawn from 671 homeless people enrolled in the study between August 2011 and April 2014. Mobile mental health outreach teams recruited homeless individuals with severe mental health illnesses who were living on the street or in emergency shelters, hospitals or prisons. Data collection was performed during face-to-face interviews. Healthcare service use included hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits to healthcare facilities or physicians' offices over a 6-month follow-up period. The data were analysed with zero-inflated (ZI) two-part models.
RESULTS


In total, 61.1% of participants had at least one hospitalisation stay over the previous 6 months, with a mean of 25 (+/- 39.2) hospital days, and the majority (51%) had visited the ED (either for regular or mental health issues) during the same time period. The results confirmed the role of financial barriers (resources and health insurance) in seeking hospital care (P < 0.05). The main predictors for hospital use in the study population were a better social functioning score (odds ratio [OR]: 1.03; P < 0.001) and having schizophrenia (OR: 1.39; P < 0.01). Higher mental health scores (assessed by the Medical Outcomes Study 36-item Short Form Health Survey) (OR: 1.03, P < 0.01) and alcohol dependence (OR: 2.13; P < 0.01) were associated with not using ED healthcare services. Being 'absolutely homeless' predicted an increased use of the ED and a zero use of outpatient services. Inversely, no association with factors related to the homelessness trajectory was found in hospital ZI negative binomial models.
CONCLUSION


This study is important because a comprehensive understanding of the determinants of healthcare use enables healthcare systems to adapt and develop. The efficiency of medicosocial interventions targeting the homeless population with mental health illnesses must also be assessed.
CLINICAL TRIAL NUMBER


NCT01570712.",2020,"Healthcare service use included hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits to healthcare facilities or physicians' offices over a 6-month follow-up period.","['homeless people with schizophrenia or bipolar disorder', 'Mobile mental health outreach teams recruited homeless individuals with severe mental health illnesses who were living on the street or in emergency shelters, hospitals or prisons', 'Data were drawn from 671 homeless people enrolled in the study between August 2011 and April 2014', 'four large French cities (the French Housing First Study', 'homeless people with severe mental health illnesses', 'homeless population with mental health illnesses']",['medicosocial interventions'],"['hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits', 'alcohol dependence ', 'social functioning score', 'hospitalisation stay', 'financial barriers (resources and health insurance', 'Higher mental health scores']","[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3178959', 'cui_str': 'Evacuation Shelter'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0642052,"Healthcare service use included hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits to healthcare facilities or physicians' offices over a 6-month follow-up period.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France. Electronic address: sandrine.loubiere@univ-amu.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Psychiatry, Sainte-Marguerite University Hospital, Marseille, 13009, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Taylor', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Loundou', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Girard', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boyer', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France.'}]",Public health,['10.1016/j.puhe.2020.05.019']
1371,32679403,"Commentary on Liu, K. et al. (2018). Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial.",,2020,,['patients with solid cancers'],['Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",[],,0.162369,,"[{'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China. Electronic address: yanpingying0116@126.com.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103691']
1372,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1373,32681472,"Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data.","INTRODUCTION


An extensive clinical development program showed that the meningococcal serogroup B-factor H binding protein (MenB-FHbp) vaccine affords protection against MenB disease for adolescents and adults. Data were pooled from multiple studies within the program to examine whether MenB-FHbp immunogenicity was influenced by sex, age, or race.
METHODS


Immunogenicity was assessed in subjects from seven studies who received 120 µg MenB-FHbp (at 0, 2, 6 months) and had evaluated immune responses against four representative test strains via serum bactericidal assays using human complement (hSBAs). Immune responses were presented by sex (male, female), age group (10-14, 15-18, 19-25, 10-25 years), and race (white, black, Asian, other).
RESULTS


Among 8026 subjects aged 10-25 years included in this analysis, MenB-FHbp elicited robust immune responses in a high percentage of subjects regardless of demographic characteristics. Across all test strains and demographic subsets, a ≥ 4-fold rise in titer from baseline was achieved in 76.7-95.0% of subjects, with no major differences by sex, age groups assessed, or races evaluated. Corresponding percentages achieving titers ≥ the lower limit of quantification (LLOQ) against all four strains combined were 79.7-87.3% (sex), 81.6-85.5% (age), and 80.0-88.1% (race). Minor differences were observed for geometric mean titers and percentages of subjects achieving titers ≥ LLOQ against each strain based on demographics.
CONCLUSION


These data suggested no clinically meaningful differences in MenB-FHbp immunogenicity when administered as a three-dose schedule based on sex, ages assessed, or races evaluated. This analysis supports the continued recommended use of MenB-FHbp to prevent MenB disease in adolescents and young adults.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers, NCT00808028, NCT01830855, NCT01323270, NCT01461993, NCT01461980, NCT01352845, and NCT01299480.",2020,"Minor differences were observed for geometric mean titers and percentages of subjects achieving titers ≥ LLOQ against each strain based on demographics.
","['8026 subjects aged 10-25\xa0years', 'adolescents and young adults', 'adolescents and adults', 'Immune responses were presented by sex (male, female), age group (10-14, 15-18, 19-25, 10-25\xa0years), and race (white, black, Asian, other', 'subjects from seven studies who received 120\xa0µg MenB-FHbp (at 0, 2, 6\xa0months) and had evaluated immune responses against four representative test strains via serum bactericidal assays using human complement (hSBAs']",[],['geometric mean titers'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0033453', 'cui_str': 'Complement factor B'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009498', 'cui_str': 'Complement'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",8026.0,0.182601,"Minor differences were observed for geometric mean titers and percentages of subjects achieving titers ≥ LLOQ against each strain based on demographics.
","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beeslaar', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Hurley, UK. johannes.beeslaar@pfizer.com.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Peyrani', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Maguire', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eiden', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Balmer', 'Affiliation': 'Pfizer Vaccine Medical Development, Scientific and Clinical Affairs, Collegeville, PA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Maansson', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00322-5']
1374,32681596,Caffeine increases strength and power performance in resistance-trained females during early follicular phase.,"The effects of 4 mg·kg -1  caffeine ingestion on strength and power were investigated for the first time, in resistance-trained females during the early follicular phase utilizing a randomized, double-blind, placebo-controlled, crossover design. Fifteen females (29.8 ± 4.0 years, 63.8 ± 5.5 kg [mean ± SD]) ingested caffeine or placebo 60 minutes before completing a test battery separated by 72 hours. One-repetition maximum (1RM), repetitions to failure (RTF) at 60% of 1RM, was assessed in the squat and bench press. Maximal voluntary contraction torque (MVC) and rate of force development (RFD) were measured during isometric knee extensions, while utilizing interpolated twitch technique to measure voluntary muscle activation. Maximal power and jump height were assessed during countermovement jumps (CMJ). Caffeine metabolites were measured in plasma. Adverse effects were registered after each trial. Caffeine significantly improved squat (4.5 ± 1.9%, effect size [ES]: 0.25) and bench press 1RM (3.3 ± 1.4%, ES: 0.20), and squat (15.9 ± 17.9%, ES: 0.31) and bench press RTF (9.8 ± 13.6%, ES: 0.31), compared to placebo. MVC torque (4.6 ± 7.3%, ES: 0.26), CMJ height (7.6 ± 4.0%, ES: 0.50), and power (3.8 ± 2.2%, ES: 0.24) were also significantly increased with caffeine. There were no differences in RFD or muscle activation. Plasma [caffeine] was significantly increased throughout the protocol, and mild side effects of caffeine were experienced by only 3 participants. This study demonstrated that 4 mg·kg -1  caffeine ingestion enhanced maximal strength, power, and muscular endurance in resistance-trained and caffeine-habituated females during the early follicular phase, with few adverse effects. Female strength and power athletes may consider using this dose pre-competition and -training as an effective ergogenic aid.",2020,"Caffeine significantly improved squat (4.5±1.9%, effect size [ES]: 0.25) and bench press 1RM (3.3±1.4%, ES: 0.20), and squat (15.9±17.9%, ES: 0.31) and bench press RTF (9.8±13.6%, ES: 0.31), compared to placebo.","['Fifteen females (29.8±4.0 years, 63.8±5.5 kg [mean±SD]) ingested', 'resistance-trained females during the early follicular phase utilizing', 'Resistance-trained Females During Early Follicular Phase']","['4 mg·kg -1  caffeine ingestion', 'caffeine', 'Caffeine', 'caffeine or placebo', 'placebo']","['Plasma [caffeine', 'Caffeine Increases Strength and Power Performance', 'CMJ height', 'Caffeine metabolites', 'maximal strength, power and muscular endurance', 'One-repetition maximum (1RM), repetitions to failure (RTF', 'Maximal power and jump height', 'Adverse effects', 'Maximal voluntary contraction torque (MVC) and rate of force development (RFD', 'MVC torque', 'RFD or muscle activation', 'squat']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0861097', 'cui_str': 'Caffeine increased'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",,0.187158,"Caffeine significantly improved squat (4.5±1.9%, effect size [ES]: 0.25) and bench press 1RM (3.3±1.4%, ES: 0.20), and squat (15.9±17.9%, ES: 0.31) and bench press RTF (9.8±13.6%, ES: 0.31), compared to placebo.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Norum', 'Affiliation': 'School of Science and Technology, London Sport Institute, Middlesex University, London, UK.'}, {'ForeName': 'Linn Christin', 'Initials': 'LC', 'LastName': 'Risvang', 'Affiliation': 'School of Science and Technology, London Sport Institute, Middlesex University, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bjørnsen', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Lygeri', 'Initials': 'L', 'LastName': 'Dimitriou', 'Affiliation': 'School of Science and Technology, London Sport Institute, Middlesex University, London, UK.'}, {'ForeName': 'Per Ola', 'Initials': 'PO', 'LastName': 'Rønning', 'Affiliation': 'Department of Mechanical, Electronics and Chemical Engineering, Faculty of Technology, Art and Design, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bjørgen', 'Affiliation': 'Department of Life Sciences and Health, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13776']
1375,32687974,Design and rationale for a randomized trial of a theory- and technology- enhanced physical activity intervention for Latinas: The Seamos Activas II study.,"INTRODUCTION


Latina women report disproportionately high rates of physical inactivity and related chronic health conditions. Physical activity (PA) efforts to date have shown modest success in this at-risk population; thus, more effective interventions are necessary to help Latinas reach national PA guidelines and reduce related health disparities. This paper describes the design, rationale, and baseline findings from the Seamos Activas II intervention.
METHODS/DESIGN


The ongoing RCT will test the efficacy of the Seamos Saludables PA print intervention vs. a theory-and technology-enhanced version (Seamos Activas II). The purpose of the study is to increase the percentage of Latinas meeting the national PA guidelines compared to the prior trial, improve biomarkers related to disease, and extend generalizability to a broader and more representative population of Latinas (i.e. Mexican/Mexican-Americans). Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies. The primary outcome is change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers at 6- and 12-months. Secondary PA outcomes assessed by the 7-Day PA Recall will be used to corroborate findings.
RESULTS


Participants (N = 199) are Latinas 18-65 years (mean = 43.8) of predominantly Mexican origin (89%). At baseline, objectively measured MVPA was 39.51 min/week (SD = 71.20, median = 10) and self-reported MVPA was 12.47 min/week (SD = 22.54, median = 0).Participants reported generally low self-efficacy and higher cognitive vs. behavioral processes of change.
CONCLUSION


Addressing interactivity and accountability through text messaging, and more rigorously targeting theoretical constructs may be key to helping Latinas achieve nationally recommended PA levels and thereby reducing health disparities.",2020,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","['representative population of Latinas (i.e. Mexican/Mexican-Americans', 'Latina women report disproportionately high rates of physical inactivity and related chronic health conditions', 'Participants (N\u202f=\u202f199) are Latinas 18-65\u202fyears (mean\u202f=\u202f43.8) of predominantly Mexican origin (89', 'Latinas']","['Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies', 'theory- and technology- enhanced physical activity intervention']","['low self-efficacy and higher cognitive vs. behavioral processes of change', 'change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2712043', 'cui_str': 'Lacking belief in own ability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0266557,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","[{'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Dori J', 'Initials': 'DJ', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health at University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Mendoza-Vasconez', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Beth C', 'Initials': 'BC', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America; Department of Human Development and Family Studies, University of Connecticut, Storrs, CT, United States of America.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America. Electronic address: bess_marcus@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106081']
1376,32682074,Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects.,"This gamma scintigraphy imaging study assessed pulmonary, extrathoracic and regional lung deposition patterns of a radiolabelled inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist triple fixed-dose combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF 320/14.4/10 μg), delivered by pressurised metered dose inhaler (pMDI) using innovative co-suspension delivery technology (Aerosphere™). In this Phase I, randomised, single-centre, single-dose, two-period, crossover study (NCT03740373), 10 healthy male adults received two actuations of BGF MDI (160/7.2/4.8 μg per actuation) radiolabelled with  99m Tc, not exceeding 5 MBq per actuation. Immediately following each inhalation, subjects performed a 10- or 3-second breath-hold, then exhaled into an exhalation filter. The primary objective was to assess the pulmonary deposition of BGF MDI following the 10-second breath-hold. The secondary objectives were to assess deposition after the 3-second breath-hold and lung regional and extrathoracic deposition after each breath-hold length. Imaging of the lungs, stomach, head and neck was recorded by gamma scintigraphy immediately after exhalation. The mean BGF MDI emitted dose deposited in the lungs was 37.7% for the 10-second breath-hold and 34.5% for the 3-second breath-hold. Emitted dose detected in the exhalation filter was ≤0.4% for both breath-hold lengths. The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively. There were no new or unexpected safety findings. In conclusion, BGF MDI was efficiently deposited in the central and the peripheral regions of the lungs, with similar regional deposition patterns following a 10- and 3-second breath-hold.",2020,"The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively.","['10 healthy male adults received', 'healthy male subjects']","['two actuations of BGF MDI', 'budesonide/glycopyrronium/formoterol fumarate dihydrate']","['exhalation filter', 'deposition after the 3-second breath-hold and lung regional and extrathoracic deposition after each breath-hold length', 'mean BGF MDI', 'pulmonary deposition of BGF MDI', 'mean normalised peripheral/central ratio', 'BGF MDI']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C1579393', 'cui_str': 'Formoterol fumarate dihydrate'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",10.0,0.0611695,"The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Israel', 'Affiliation': 'Simbec Research Ltd, Merthyr Tydfil, South Wales, CF48 4DR, UK.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Kelly Services Global LLC, Suite 401A, 999W. Big Beaver Rd., Troy, MI, 48084, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'Formerly of AstraZeneca, 4222 Emperor Blvd, Suite 560, Durham, NC, 27703, USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'AstraZeneca Gothenburg, Pepparedsleden 1, SE-431 50, Mölndal, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, 4222 Emperor Blvd, Suite 560, Durham, NC, 27703, USA. Electronic address: paul.dorinsky1@astrazeneca.com.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Respiratory Medicine, Hôpital Cochin (AP-HP), University Paris Descartes, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Usmani', 'Affiliation': 'National Heart and Lung Institute (NHLI), Imperial College London & Royal Brompton Hospital, Guy Scadding Building, Dovehouse St, Chelsea, London SW3 6LY, UK.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105472']
1377,32630031,Influence of Dietary Supplementation for Hyperhomocysteinemia Treatments.,"Hyperhomocysteinemia is recognized as risk factor for cardiovascular and age-associated diseases. Folic acid supplementation efficiently lowers plasma homocysteine (Hcy) levels, but high intake may negatively affect health because of unnatural levels of unmetabolized folic acid in the systemic circulation. Oxoproline (Oxo) provides by glutamic acid production an increase of intracellular folic acid trapping. Aim of this study was to compare the efficacy of three supplementation protocols: (1) traditional therapy (5-methyl-tetrahydrofolate: 15 mg/day); (2) 5 mL/day of Oxo with 300 μg folic acid (oxifolic); (3) 5 mL/day of Oxo alone (magnesio+) in a 90 days randomized trial on thirty-two moderate hyperhomocysteinemic (18.6 ± 2.4 μmol.L -1 ) patients (age 48 ± 14 yrs). Thiols: cysteine (Cys), cysteinylglycine (Cys-Gly) and glutathione levels were assessed too. Every supplementation induced significant ( p  range <0.05-0.0001) reductions of Hcy level and Cys concentration after the three protocols adopted. Otherwise glutathione concentration significantly increased after oxifolic ( p  < 0.01) and traditional ( p  < 0.05) supplementation. The integration of Oxo resulted an interesting alternative to traditional therapy because absence or minimal number of folates in the integrator eliminates any chance of excess that can constitute a long-term risk.",2020,Every supplementation induced significant ( p  range <0.05-0.0001) reductions of Hcy level and Cys concentration after the three protocols adopted.,['L -1 ) patients (age 48 ± 14 yrs'],"['Oxo with 300 μg folic acid (oxifolic); (3) 5 mL/day of Oxo alone (magnesio', 'Folic acid supplementation', 'Dietary Supplementation', 'supplementation protocols: (1) traditional therapy (5-methyl-tetrahydrofolate', 'Oxoproline (Oxo']","['plasma homocysteine (Hcy) levels', 'Hcy level and Cys concentration', 'Thiols: cysteine (Cys), cysteinylglycine (Cys-Gly) and glutathione levels', 'Otherwise glutathione concentration']","[{'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039669', 'cui_str': 'Tetrahydrofolates'}]","[{'cui': 'C1278165', 'cui_str': 'Plasma homocysteine measurement'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0056886', 'cui_str': 'cysteinylglycine'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}]",32.0,0.0328471,Every supplementation induced significant ( p  range <0.05-0.0001) reductions of Hcy level and Cys concentration after the three protocols adopted.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Vezzoli', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Dellanoce', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Teresa Maria', 'Initials': 'TM', 'LastName': 'Caimi', 'Affiliation': 'S.S Emostasi, S.C. Ematologia ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Vietti', 'Affiliation': ""Driatec srl, Cassina de' Pecchi, 20060 Milan, Italy.""}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Montorsi', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, San Raffaele Roma Open University, 20122 Milan, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Mrakic-Sposta', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Accinni', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}]",Nutrients,['10.3390/nu12071957']
1378,32630697,Leptin and Nutrition in Gestational Diabetes.,"Leptin is highly expressed in the placenta, mainly by trophoblastic cells, where it has an important autocrine trophic effect. Moreover, increased leptin levels are found in the most frequent pathology of pregnancy: gestational diabetes, where leptin may mediate the increased size of the placenta and the fetus, which becomes macrosomic. In fact, leptin mediates the increased protein synthesis, as observed in trophoblasts from gestational diabetic subjects. In addition, leptin seems to facilitate nutrients transport to the fetus in gestational diabetes by increasing the expression of the glycerol transporter aquaporin-9. The high plasma leptin levels found in gestational diabetes may be potentiated by leptin resistance at a central level, and obesity-associated inflammation plays a role in this leptin resistance. Therefore, the importance of anti-inflammatory nutrients to modify the pathology of pregnancy is clear. In fact, nutritional intervention is the first-line approach for the treatment of gestational diabetes mellitus. However, more nutritional intervention studies with nutraceuticals, such as polyphenols or polyunsaturated fatty acids, or nutritional supplementation with micronutrients or probiotics in pregnant women, are needed in order to achieve a high level of evidence. In this context, the Mediterranean diet has been recently found to reduce the risk of gestational diabetes in a multicenter randomized trial. This review will focus on the impact of maternal obesity on placental inflammation and nutrients transport, considering the mechanisms by which leptin may influence maternal and fetal health in this setting, as well as its role in pregnancy pathologies.",2020,"In addition, leptin seems to facilitate nutrients transport to the fetus in gestational diabetes by increasing the expression of the glycerol transporter aquaporin-9.","['pregnant women', 'gestational diabetes mellitus', 'Gestational Diabetes', 'gestational diabetic subjects']",[],"['protein synthesis', 'leptin levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",[],"[{'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0142626,"In addition, leptin seems to facilitate nutrients transport to the fetus in gestational diabetes by increasing the expression of the glycerol transporter aquaporin-9.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pérez-Pérez', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, and Immnology, School of Medicine, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Vilariño-García', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, and Immnology, School of Medicine, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Guadix', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Dueñas', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Sánchez-Margalet', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, and Immnology, School of Medicine, Virgen Macarena University Hospital, 41009 Seville, Spain.'}]",Nutrients,['10.3390/nu12071970']
1379,32630786,Bifidobacterium longum subsp. longum  OLP-01 Supplementation during Endurance Running Training Improves Exercise Performance in Middle- and Long-Distance Runners: A Double-Blind Controlled Trial.,"Bifidobacterium longum subsp. longum  Olympic No. 1 (OLP-01) has been shown in previous animal experiments to improve exercise endurance performance, but this effect has not been confirmed in humans, or more particularly, in athletes. Toward this end, the current study combined OLP-01 supplementation with regular exercise training in well-trained middle- and long-distance runners at the National Taiwan Sport University. The study was designed as a double-blind placebo-controlled experiment. Twenty-one subjects (14 males and seven females aged 20-30 years) were evenly distributed according to total distance (meters) traveled in 12 min to one of the following two groups: a placebo group (seven males and three females) and an OLP-01 (1.5 × 10 10  colony forming units (CFU)/day) group (seven males and four females). All the participants received placebo or OLP-01 supplements for five consecutive weeks consisting of three weeks of regular training and two weeks of de-training. Before and after the experiment, the participants were tested for 12-min running/walking distance, and body composition, blood/serum, and fecal samples were analyzed. The results showed that OLP-01 significantly increased the change in the 12-min Cooper's test running distance and the abundance of gut microbiota. Although no significant change in body composition was found, OLP-01 caused no adverse reactions or harm to the participants' bodies. In summary, OLP-01 can be used as a sports nutrition supplement, especially for athletes, to improve exercise performance.",2020,"Although no significant change in body composition was found, OLP-01 caused no adverse reactions or harm to the participants' bodies.","['well-trained middle- and long-distance runners at the National Taiwan Sport University', 'Middle- and Long-Distance Runners', 'group (seven males and three females) and an OLP-01 (1.5 × 10 10  colony forming units (CFU)/day) group (seven males and four females', 'Twenty-one subjects (14 males and seven females aged 20-30 years']","['placebo or OLP-01 supplements', 'Bifidobacterium longum subsp', 'longum', 'OLP-01 supplementation with regular exercise training', 'Endurance Running Training', 'placebo']","['Exercise Performance', 'exercise endurance performance', 'body composition', ""12-min Cooper's test running distance and the abundance of gut microbiota"", 'OLP-01', 'exercise performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.105597,"Although no significant change in body composition was found, OLP-01 caused no adverse reactions or harm to the participants' bodies.","[{'ForeName': 'Che-Li', 'Initials': 'CL', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedic Surgery, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}, {'ForeName': 'Hsieh-Hsun', 'Initials': 'HH', 'LastName': 'Ho', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Yung-Cheng', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Training Science-Athletics, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}, {'ForeName': 'Yi-Wei', 'Initials': 'YW', 'LastName': 'Kuo', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Yao-Tsung', 'Initials': 'YT', 'LastName': 'Yeh', 'Affiliation': 'Department of Medical Laboratory Sciences and Biotechnology, Fooyin University, Kaohsiung City 83102, Taiwan.'}, {'ForeName': 'Shin-Yu', 'Initials': 'SY', 'LastName': 'Tsai', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Ching-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Jui-Fen', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Chi-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}, {'ForeName': 'Mon-Chien', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}]",Nutrients,['10.3390/nu12071972']
1380,32634642,Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations.,"PURPOSE


This randomized double-blind study aimed to evaluate the effects of dexmedetomidine on hemodynamic parameters and the quality of surgery and recovery criteria in tympanoplasty operations.
MATERIALS AND METHODS


A total of 75 patients 18-55 years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II, were randomly divided into three groups. Group 1 included patients receiving remifentanil alone, Group 2 included patients receiving dexmedetomidine + remifentanil and Group 3 included patients receiving dexmedetomidine + ½ remifentanil. Anesthesia was induced with propofol and cisatracurium. For maintenance of anesthesia, a mixture of 2-2.5% sevoflurane, 40-60% oxygen/air was used. The groups were compared in terms of hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects.
RESULTS


Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3. Surgical field satisfaction was higher in Group 2 and Group 3 than Group 1. Spontaneous breathing, eye opening and verbal cooperation times were shorter in Group 3 compared to Group 2. Eye opening and verbal cooperation times were longer in Group 2 compared to Group 1. The 30-minute modified Aldrete scores was higher in Group 3 compared to Group 1. There was no difference between the groups in terms of postoperative pain and adverse effects.
CONCLUSION


The use of dexmedetomidine during tympanoplasty operations may provide better hemodynamic control and surgical view, may provide faster recovery and may reduce remifentanil consumption.",2020,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","['75 patients 18-55\xa0years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II']","['dexmedetomidine + ½ remifentanil', 'remifentanil alone', 'propofol and cisatracurium', 'sevoflurane', 'dexmedetomidine', 'dexmedetomidine + remifentanil']","['Eye opening and verbal cooperation times', 'Mean arterial pressure and heart rate values', 'Surgical field satisfaction', 'Spontaneous breathing, eye opening and verbal cooperation times', 'postoperative pain and adverse effects', 'hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects', 'tympanoplasty operations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.0542959,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Bengu', 'Initials': 'B', 'LastName': 'Cobanoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Otorhinolaryngology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102619']
1381,32635429,A Review of Topical Phage Therapy for Chronically Infected Wounds and Preparations for a Randomized Adaptive Clinical Trial Evaluating Topical Phage Therapy in Chronically Infected Diabetic Foot Ulcers.,"The advent and increasing prevalence of antimicrobial resistance commensurate with the absence of novel antibiotics on the horizon raises the specter of untreatable infections. Phages have been safely administered to thousands of patients exhibiting signals of efficacy in many experiencing infections refractory to antecedent antibiotics. Topical phage therapy may represent a convenient and efficacious treatment modality for chronic refractory infected cutaneous wounds spanning all classifications including venous stasis, burn-mediated, and diabetic ulcers. We will initially provide results from a systematic literature review of topical phage therapy used clinically in refractorily infected chronic wounds. We will then segue into a synopsis of the preparations for a forthcoming phase II a randomized placebo-controlled clinical trial assessing the therapeutic efficacy exploiting adjunctive personalized phage administration, delivered topically, intravenously (IV) and via a combination of both modalities (IV + topical) in the treatment of infected diabetic foot ulcers (perhaps the canonical paradigm representing complicated recalcitrant infected cutaneous wounds).",2020,"Topical phage therapy may represent a convenient and efficacious treatment modality for chronic refractory infected cutaneous wounds spanning all classifications including venous stasis, burn-mediated, and diabetic ulcers.","['infected diabetic foot ulcers (perhaps the canonical paradigm representing complicated recalcitrant infected cutaneous wounds', 'Chronically Infected Diabetic Foot Ulcers', 'Chronically Infected Wounds and Preparations']","['Topical phage therapy', 'Topical Phage Therapy', 'placebo']",[],"[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4277645', 'cui_str': 'Bacteriophage Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0417629,"Topical phage therapy may represent a convenient and efficacious treatment modality for chronic refractory infected cutaneous wounds spanning all classifications including venous stasis, burn-mediated, and diabetic ulcers.","[{'ForeName': 'Christopher Anthony', 'Initials': 'CA', 'LastName': 'Duplessis', 'Affiliation': 'Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Biswas', 'Affiliation': 'Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9070377']
1382,32635494,Phytoplankton Supplementation Lowers Muscle Damage and Sustains Performance across Repeated Exercise Bouts in Humans and Improves Antioxidant Capacity in a Mechanistic Animal.,"The purpose of this study was to investigate the impact of antioxidant-rich marine phytoplankton supplementation (Oceanix, OCX) on performance and muscle damage following a cross-training event in endurance-trained subjects. Additionally, an animal model was carried out to assess the effects of varying dosages of OCX, with exercise, on intramuscular antioxidant capacity.
METHODS


In the human trial, endurance-trained subjects (average running distance = 29.5 ± 2.6 miles × week -1 ) were randomly divided into placebo (PLA) and OCX (25 mg) conditions for 14 days. The subjects were pre-tested on a one-mile uphill run, maximal isometric strength, countermovement jump (CMJ) and squat jump (SJ) power, and for muscle damage (creatine kinase (CK)). On Day 12, the subjects underwent a strenuous cross-training event. Measures were reassessed on Day 13 and 14 (24 h and 48 h Post event). In the animal model, Wistar rats were divided into four groups ( n  = 7): (i) Control (no exercise and placebo (CON)), (ii) Exercise (E), (iii) Exercise + OCX 1 (Oceanix, 2.55 mg/day, (iv) Exercise + OCX 2 (5.1 mg/day). The rats performed treadmill exercise five days a week for 6 weeks. Intramuscular antioxidant capacity (superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GSH-Px)) and muscle damage (CK and myoglobin (MYOB) were collected. The data were analyzed using repeated measures ANOVA and  t -test for select variables. The alpha value was set at  p  < 0.05.
RESULTS


For the human trial, SJ power lowered in PLA relative to OCX at 24 h Post (-15%,  p  < 0.05). Decrements in isometric strength from Pre to 48 h Post were greater in the PLA group (-12%,  p  < 0.05) than in the OCX. Serum CK levels were greater in the PLA compared to the OCX (+14%,  p  < 0.05). For the animal trial, the intramuscular antioxidant capacity was increased in a general dose-dependent manner (E + Oc2 > E + Oc1 > E > CON). Additionally, CK and MYOB were lower in supplemented compared to E alone.
CONCLUSIONS


Phytoplankton supplementation (Oceanix) sustains performance and lowers muscle damage across repeated exercise bouts. The ingredient appears to operate through an elevating oxidative capacity in skeletal muscle.",2020,"Serum CK levels were greater in the PLA compared to the OCX (+14%,  p  < 0.05).","['endurance-trained subjects', 'human trial, endurance-trained subjects (average running distance = 29.5 ± 2.6 miles × week -1 ', 'Wistar rats were divided into four groups ( n  = 7']","['OCX 1 (Oceanix, 2.55 mg/day, (iv) Exercise ', 'OCX', 'antioxidant-rich marine phytoplankton supplementation (Oceanix, OCX', 'Phytoplankton Supplementation', 'i) Control (no exercise and placebo (CON)), (ii) Exercise (E), (iii', ' Exercise ', 'placebo (PLA) and OCX']","['Serum CK levels', 'intramuscular antioxidant capacity', 'maximal isometric strength, countermovement jump (CMJ) and squat jump (SJ) power, and for muscle damage (creatine kinase (CK', 'CK and MYOB', 'Intramuscular antioxidant capacity (superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GSH-Px)) and muscle damage (CK and myoglobin (MYOB', 'isometric strength']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034716', 'cui_str': 'Wistar rat'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0031865', 'cui_str': 'Phytoplankton'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}]",,0.0452336,"Serum CK levels were greater in the PLA compared to the OCX (+14%,  p  < 0.05).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sharp', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Kazim', 'Initials': 'K', 'LastName': 'Sahin', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stefan', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Orhan', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Raad', 'Initials': 'R', 'LastName': 'Gheith', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Dallen', 'Initials': 'D', 'LastName': 'Reber', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Nurhan', 'Initials': 'N', 'LastName': 'Sahin', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Tuzcu', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lowery', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Durkee', 'Affiliation': 'Lonza Consumer Health Inc., Morristown, NJ 07960, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}]",Nutrients,['10.3390/nu12071990']
1383,32639099,Ex vivo-expanded autologous adipose tissue-derived stromal cells ensure enhanced fat graft retention in breast augmentation: A randomized controlled clinical trial.,"Autologous fat grafting and implant surgery are used for volume restoration in plastic surgery. With the aim of producing a treatment superior to current solutions, we report a randomized, controlled, data assessor-blinded clinical trial comparing fat grafts enriched with ex vivo-expanded autologous adipose-derived stromal cells (ASCs) to nonenriched fat grafts in breast augmentation. The intervention group received ASC-enriched fat grafts (≥20 × 10 6  viable ex vivo-expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts. Volume retention was measured by magnetic resonance imaging, and clinical photographs were taken simultaneously for outcome evaluation. ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%). Clinical photos showed statistically significant superior results in the intervention group, assessed by independent clinical experts. These results improve the prospects for using culture-expanded ASCs in both reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants. This study is registered at www.clinicaltrials.gov, number H-16046960.",2020,ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%).,"['plastic surgery', 'breast augmentation']","['ASC-enriched fat grafts (≥20\u2009×\u200910 6  viable ex vivo-expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts', 'Autologous fat grafting and implant surgery', 'fat grafts enriched with ex vivo-expanded autologous adipose-derived stromal cells (ASCs', 'Ex vivo-expanded autologous adipose tissue-derived stromal cells']","['retention rates', 'Volume retention']","[{'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}]","[{'cui': 'C3710940', 'cui_str': 'STS protein, human'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0761152,ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%).,"[{'ForeName': 'Stig-Frederik T', 'Initials': 'ST', 'LastName': 'Kølle', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Duscher', 'Affiliation': 'Department of Plastic and Hand Surgery, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Taudorf', 'Affiliation': 'Department of Radiology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fischer-Nielsen', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Jesper D', 'Initials': 'JD', 'LastName': 'Svalgaard', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Munthe-Fog', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jønsson', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Selvig', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Frederik P', 'Initials': 'FP', 'LastName': 'Mamsen', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Katz', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}]",Stem cells translational medicine,['10.1002/sctm.20-0081']
1384,32641374,The Association Between HbA 1c  and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4).,"OBJECTIVE


According to recent guidelines, individuals with type 1 diabetes should spend <4.0% per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).
RESEARCH DESIGN AND METHODS


In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA 1c  levels.
RESULTS


Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA 1c  and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA 1c  <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA 1c  7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
CONCLUSIONS


Reaching current targets for time in hypoglycemia while at the same time reaching HbA 1c  targets is challenging for type 1 diabetes patients treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA 1c  levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets.",2020,"Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
","['People With Type 1 Diabetes and Multiple Daily Insulin Injections', '161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI']","['CGM', 'continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG', 'CGM and Self-Monitoring of Blood Glucose']","['mean HbA 1c  and mean glucose levels', 'mean time spent in hypoglycemia', 'time spent in hypoglycemia and various mean glucose and HbA 1c  levels', 'Time spent in hypoglycemia', 'time with glucose levels', 'mean glucose levels', 'time spent in hypoglycemia', 'HbA 1c  and Time in Hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",161.0,0.01482,"Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
","[{'ForeName': 'Shilan', 'Initials': 'S', 'LastName': 'Seyed Ahmadi', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden shilan.seyed.ahmadi@vgregion.se.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Westman', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Aldina', 'Initials': 'A', 'LastName': 'Pivodic', 'Affiliation': 'Statistiska Konsultgruppen, Gothenburg, Sweden.'}, {'ForeName': 'Arndís F', 'Initials': 'AF', 'LastName': 'Ólafsdóttir', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Dahlqvist', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, WA.'}, {'ForeName': 'Jarl', 'Initials': 'J', 'LastName': 'Hellman', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Type 1 Diabetes & Functional Insulins, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Wijkman', 'Affiliation': 'Department of Internal Medicine and Department of Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Schwarcz', 'Affiliation': 'Department of Medicine, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}]",Diabetes care,['10.2337/dc19-2606']
1385,32643327,Effects of an electric toothbrush combined with 3-color light-emitting diodes on antiplaque and bleeding control: a randomized controlled study.,"PURPOSE


This randomized controlled study aimed to evaluate the effects of an electric toothbrush with 3 colors of light-emitting diodes (LEDs) on antiplaque and bleeding control.
METHODS


This randomized, placebo-controlled, double-blinded, parallel-group clinical trial included 50 healthy adults with gingivitis, who were randomly assigned to 2 groups. The experimental group used electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush as the experimental group, but with LED sources with one-hundredth of the strength. The subjects used the electric toothbrush 3 times a day for 4 minutes each time. As clinical indices, bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI) were assessed at baseline, at 3 weeks, and at 6 weeks.
RESULTS


There were significant decreases in all clinical indices (BOMP, GI, QHI) in both the experimental and control groups compared to baseline at 3 weeks and at 6 weeks. In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05). However, at 6 weeks, statistically significant differences were observed between the experimental and control groups in BOMP and GI, which are indicators of gingival inflammation ( P <0.05).
CONCLUSIONS


This study demonstrated that an electric toothbrush combined with 3-color LEDs reduced gingival bleeding and inflammation after 6 weeks.",2020,"In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05).",['50 healthy adults with gingivitis'],"['electric toothbrush with 3 colors of light-emitting diodes (LEDs', 'electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush', 'electric toothbrush combined with 3-color LEDs', 'electric toothbrush combined with 3-color light-emitting diodes', 'placebo']","['gingival bleeding and inflammation', 'gingival inflammation', 'bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI', 'BOMP and GI', 'clinical indices (BOMP, GI, QHI', 'antiplaque and bleeding control']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}]",50.0,0.0547114,"In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05).","[{'ForeName': 'Chakyoung', 'Initials': 'C', 'LastName': 'Kwon', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Jae Mok', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Jo Young', 'Initials': 'JY', 'LastName': 'Suh', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Seung Jun', 'Initials': 'SJ', 'LastName': 'Seo', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Youngkyun', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Biochemistry, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Yong Gun', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea. periokyg@knu.ac.kr.'}]",Journal of periodontal & implant science,['10.5051/jpis.2001800090']
1386,32649925,"Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study.","BACKGROUND


Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis.
METHODS


We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433.
FINDINGS


Of 101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68·6 (SD 17·3) for antipsychotic monotherapy (6·2 points lower than at randomisation), 59·8 (13·7) for psychological intervention (13·1 points lower than at randomisation), and 62·0 (15·9) for antipsychotics plus psychological intervention (13·9 points lower than at randomisation). A good clinical response at 6 months (defined as ≥50% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial.
INTERPRETATION


This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence.
FUNDING


National Institute for Health Research.",2020,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","['101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to', 'young people with first-episode psychosis', 'adolescents with first-episode psychosis (MAPS', 'participants from seven UK National Health Service Trust sites', 'adolescents with first-episode psychosis', 'Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service', 'The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups', 'early-onset psychosis']","['CBT', 'antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention', 'antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT', 'antipsychotic monotherapy', 'Antipsychotic medication versus psychological intervention', 'antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention', 'antipsychotics plus psychological intervention']","['feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS', 'serious adverse events', 'PANSS total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0011251', 'cui_str': 'Delusional disorder'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",61.0,0.11201,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Morrison', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK. Electronic address: anthony.p.morrison@manchester.ac.uk.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pyle', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Maughan', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Broome', 'Affiliation': ""Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK; Institute for Mental Health and Centre for Human Brain Health, School of Psychology, University of Birmingham, Birmingham, UK; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK; Early Intervention in Psychosis Service, Lancashire and South Cumbria NHS Foundation Trust, Chorley, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh Medical School, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'National Institute for Health Research (NIHR) MindTech MedTech Co-operative and NIHR Nottingham Biomedical Research Centre, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30248-0']
1387,32650033,Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications.,"AIM


Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required.
METHODS


We compared improvement in glycaemic control in a pooled set of people assigned to the ""placebo"" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated.
RESULTS


The overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between -0.23% (-2.50 mmol/mol) and -0.32% (-3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months.
CONCLUSIONS


Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.",2020,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"['people with diabetes and their healthcare team', 'people with diabetes', 'younger and older adults with diabetes having comorbidities and progressive complications', 'people living with diabetes']","['sham or non-pharmacological intervention', 'placebo']","['metabolic parameters', 'fasting plasma glucose', 'Mean change in HbA1c (ANCOVA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.202893,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"[{'ForeName': 'William David', 'Initials': 'WD', 'LastName': 'Strain', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom; Academic Department of Healthcare for the Elderly, Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom. Electronic address: d.strain@exeter.ac.uk.'}, {'ForeName': 'Päivi Maria', 'Initials': 'PM', 'LastName': 'Paldánius', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108310']
1388,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
1389,32657759,Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial.,"BACKGROUND


Sepsis remains a major health challenge with high mortality. Adequate volume administration is fundamental for a successful outcome. However, individual fluid needs differ between patients due to varying degrees of systemic vasodilation, circulatory flow maldistribution, and increased vascular permeability. The current fluid resuscitation practice has been questioned. Fluid overload is associated with higher mortality in sepsis. A sign of fluid overload is extravascular lung water, seen as B lines in lung ultrasound. B lines correlate inversely with oxygenation (measured by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen ie, PaO2/FiO2). Thus, B lines seen by bedside ultrasound may have a role in guiding fluid therapy.
OBJECTIVE


We aim to evaluate if fluid administration guided by lung ultrasound in patients with sepsis in emergency departments will lead to better oxygenation and patient outcomes than those in the standard therapy.
METHODS


A phase II, multicenter, randomized, open-label, parallel-group, superiority trial will be performed. Patients will be recruited at emergency departments of the participating centers. A total of 340 patients will be randomly allocated to the intervention or standard-of-care group (30mL/kg). The intervention group will receive ultrasound-guided intravenous fluid until 3 B lines appear. The primary outcome will be oxygenation (measured as PaO2/FiO2 ratio) at 48 hours after starting intravenous fluid administration. Secondary outcomes will be patients' outcome parameters, including oxygenation after 15 mL/kg fluid at 6, 12, 24, and 48 hours; sepsis progress through Sequential Organ Failure Assessment (SOFA) scores; pulmonary edema evaluation; and 30-day mortality.
RESULTS


The trial will be conducted in accordance with the Declaration of Helsinki. Institutional review board approval will be sought after the participating sites are selected. The protocol will be registered once the institutional review board approval is granted. The trial duration is expected to be 1.5-2.5 years. The study is planned to be performed from 2021 to 2022, with enrollment starting in 2021. First results are expected in 2022. Informed written consent will be obtained before the patient's enrollment in the study. An interim analysis and data monitoring will ensure the patient safety. The results will be published in a peer-reviewed journal and discussed at international conferences.
CONCLUSIONS


This is a protocol for a randomized control trial that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B lines evaluation.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/15997.",2020,"This is a protocol for an RCT that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B-Lines evaluation.
","['Patients with Sepsis', 'patients with sepsis via B-Lines evaluation', '340 patients', '2021 to 2022, with enrolment starting in 2021', 'patients with sepsis in the Emergency Departments (ED']",['Lung Ultrasound (FERLU'],"[""patients' outcome parameters, including oxygenation, sepsis progress (SOFA), pulmonary edema course after 15ml/kg fluid and at 6, 12, 24, 48 hrs and 30-day mortality"", 'oxygenation (PaO2/FiO2', 'vascular permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0162337', 'cui_str': 'Blood vessel permeability'}]",340.0,0.211776,"This is a protocol for an RCT that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B-Lines evaluation.
","[{'ForeName': 'Mouhand F H', 'Initials': 'MFH', 'LastName': 'Mohamed', 'Affiliation': 'Department of General Internal Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Malewicz', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Hanan Ibrahim', 'Initials': 'HI', 'LastName': 'Zehry', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Dina A Monim', 'Initials': 'DAM', 'LastName': 'Hussain', 'Affiliation': 'Department of Obstetrics and Gynecology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Judah Leão', 'Initials': 'JL', 'LastName': 'Barouh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Adriana V', 'Initials': 'AV', 'LastName': 'Cançado', 'Affiliation': 'Radiology Department, Santa Casa Belo Horizonte, Belo Horizonte, Brazil.'}, {'ForeName': 'Jeancarllo Sousa', 'Initials': 'JS', 'LastName': 'Silva', 'Affiliation': 'Division of Oncological Surgery, State University of Amazonas, Manaus, Brazil.'}, {'ForeName': 'Salah', 'Initials': 'S', 'LastName': 'Suwileh', 'Affiliation': 'Department of General Internal Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Jose Retamal', 'Initials': 'JR', 'LastName': 'Carvajal', 'Affiliation': 'Faculty Of Emergency Medicine, Universidad Del Desarrollo-Clinica Alemana De Santiago, Santiago, Chile.'}]",JMIR research protocols,['10.2196/15997']
1390,32653414,"Re: Toni K. Choueiri, Daniel Y.C. Heng, Jae Lyun Lee, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. In press. https://doi.org/10.1001/jamaoncol.2020.2218: SAVOIR: From Own Goal to Winning Goal?",,2020,,"['Patients With MET-Driven Papillary Renal Cell Carcinoma', 'https://doi.org/10.1001/jamaoncol.2020.2218']","['SAVOIR', 'Savolitinib vs Sunitinib']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}]",[],,0.0560533,,"[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: francesco.massari@aosp.bo.it.'}]",European urology oncology,['10.1016/j.euo.2020.06.008']
1391,32653539,The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.,"Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.",2020,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","['African American adults with uncontrolled diabetes and multiple chronic health conditions', ' African American patients with uncontrolled diabetes living in medically underserved areas', 'Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability', '646 patients (n\u202f=\u202f581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC', 'African Americans individuals with uncontrolled diabetes']","['Text messaging (TM) and health coaching (HC', 'text messaging versus health coaching', 'TM and HC with enhanced usual care (EC']","['diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c', 'general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",646.0,0.105121,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Bailey', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America. Electronic address: jeb@uthsc.edu.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Surbhi', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gatwood', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Butterworth', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Q-consult, LLC, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Sohul A', 'Initials': 'SA', 'LastName': 'Shuvo', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ankur A', 'Initials': 'AA', 'LastName': 'Dashputre', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Brooks', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Surgery, Anne Arundel Medical Center, Annapolis, MD, United States of America.'}, {'ForeName': 'Bonnie L', 'Initials': 'BL', 'LastName': 'Binkley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Carrie Jo', 'Initials': 'CJ', 'LastName': 'Riordan', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Helmut O', 'Initials': 'HO', 'LastName': 'Steinberg', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of Endocrinology, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Gutierrez', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Haley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Cardella L', 'Initials': 'CL', 'LastName': 'Leak', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tolley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106080']
1392,32643326,Evaluation of the mechanical properties and clinical efficacy of biphasic calcium phosphate-added collagen membrane in ridge preservation.,"PURPOSE


This study aimed to evaluate the biocompatibility and the mechanical properties of ultraviolet (UV) cross-linked and biphasic calcium phosphate (BCP)-added collagen membranes and to compare the clinical results of ridge preservation to those obtained using chemically cross-linked collagen membranes.
METHODS


The study comprised an  in vitro  test and a clinical trial for membrane evaluation. BCP-added collagen membranes with UV cross-linking were prepared. In the  in vitro  test, scanning electron microscopy, a collagenase assay, and a tensile strength test were performed. The clinical trial involved 14 patients undergoing a ridge preservation procedure. All participants were randomly divided into the test group, which received UV cross-linked membranes (n=7), and the control group, which received chemically cross-linked membranes (n=7). BCP bone substitutes were used for both the test group and the control group. Cone-beam computed tomography (CBCT) scans were performed and alginate impressions were taken 1 week and 3 months after surgery. The casts were scanned via an optical scanner to measure the volumetric changes. The results were analyzed using the nonparametric Mann-Whitney  U  test.
RESULTS


The fastest degradation rate was found in the collagen membranes without the addition of BCP. The highest enzyme resistance and the highest tensile strength were found when the collagen-to-BCP ratio was 1:1. There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
CONCLUSIONS


The addition of BCP and UV cross-linking improved the biocompatibility and the mechanical strength of the membranes. Within the limits of the clinical trial, the sites grafted using BCP in combination with UV cross-linked and BCP-added collagen membranes (test group) did not show any statistically significant difference in terms of dimensional change compared with the control group.",2020,"There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
",['14 patients undergoing a ridge preservation procedure'],"['Cone-beam computed tomography (CBCT) scans', 'UV cross-linked membranes (n=7), and the control group, which received chemically cross-linked membranes', 'ultraviolet (UV) cross-linked and biphasic calcium phosphate (BCP)-added collagen membranes', 'biphasic calcium phosphate-added collagen membrane']","['dimensional change', 'highest enzyme resistance and the highest tensile strength', 'fastest degradation rate', '3-dimensional modeling or CBCT scans', 'dimensional changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0210087', 'cui_str': 'hydroxyapatite-beta tricalcium phosphate'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",14.0,0.0258414,"There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
","[{'ForeName': 'Jung Tae', 'Initials': 'JT', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontics, One-Stop Specialty Center, Seoul National University Dental Hospital, Seoul, Korea.'}, {'ForeName': 'Yoonsub', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Dajung', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Yusang', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Bio Team, Implant Research Institute, Dentis Co., Ltd., Daegu, Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Bio Team, Implant Research Institute, Dentis Co., Ltd., Daegu, Korea.'}, {'ForeName': 'Sungtae', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea. kst72@snu.ac.kr.'}]",Journal of periodontal & implant science,['10.5051/jpis.2001080054']
1393,32651286,"A randomized, placebo-controlled, phase 2 trial of laquinimod in primary progressive multiple sclerosis.","OBJECTIVE


To evaluate efficacy, safety, and tolerability of laquinimod in patients with primary progressive multiple sclerosis (PPMS).
METHODS


In the randomized, double-blind, placebo-controlled, phase 2 study, ARPEGGIO (A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations in MRI and Clinical Outcomes), eligible patients with PPMS were randomized 1:1:1 to receive once-daily oral laquinimod 0.6 mg or 1.5 mg or matching placebo. Percentage brain volume change (PBVC; primary endpoint) from baseline to week 48 was assessed by MRI. Secondary and exploratory endpoints included clinical and MRI measures. Efficacy endpoints were evaluated using a predefined, hierarchical statistical testing procedure. Safety was monitored throughout the study. The laquinimod 1.5 mg dose arm was discontinued on January 1, 2016, due to findings of cardiovascular events.
RESULTS


A total of 374 patients were randomized to laquinimod 0.6 mg (n = 139) or 1.5 mg (n = 95) or placebo (n = 140). ARPEGGIO did not meet the primary endpoint of significant treatment effect with laquinimod 0.6 mg vs placebo on PBVC from baseline to week 48 (adjusted mean difference = 0.016%,  p  = 0.903). Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001). Incidence of adverse events was higher among patients treated with laquinimod 0.6 mg (83%) vs laquinimod 1.5 mg (66%) and placebo (78%).
CONCLUSIONS


Laquinimod 0.6 mg did not demonstrate a statistically significant effect on brain volume loss in PPMS at week 48.
CLINICALTRIALSGOV IDENTIFIER


NCT02284568.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, although well tolerated, laquinimod 0.6 mg did not demonstrate a significant treatment effect on PBVC in patients with PPMS.",2020,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","['primary progressive multiple sclerosis', 'patients with primary progressive multiple sclerosis (PPMS', '374 patients', 'eligible PPMS patients']","['Placebo', 'laquinimod 0.6 mg or 1.5 mg or matching placebo', 'Laquinimod', 'laquinimod', 'placebo']","['Safety', 'number of new T2 brain lesions', 'clinical and MRI measures', 'brain volume loss', 'Percentage brain volume change (PBVC', 'efficacy, safety, and tolerability', 'Incidence of adverse events', 'PBVC']","[{'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1260208', 'cui_str': 'laquinimod'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",374.0,0.695841,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK. g.giovannoni@qmul.ac.uk.""}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Knappertz', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Steinerman', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Tansy', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Krieger', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Uccelli', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pia Sormani', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lublin', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}]",Neurology,['10.1212/WNL.0000000000010284']
1394,32651322,The Effects of Propofol and Sevoflurane on Postoperative Delirium in Older Patients: A Randomized Clinical Trial Study.,"BACKGROUND


Postoperative delirium is associated with adverse postoperative outcomes. However, whether intravenous and inhalation anesthetics are associated with different risks of postoperative delirium remains unknown.
OBJECTIVE


We set up to determine the incidence and duration of postoperative delirium in older patients who had surgery under the intravenous anesthetic propofol or the inhalational anesthetic sevoflurane.
METHODS


Participants were patients who had total hip/knee replacements and were randomized to propofol (N = 106) or sevoflurane (N = 103) anesthesia group. The Confusion Assessment Method was employed by investigators who were blinded to the anesthesia regimen to assess the incidence and duration (days of postoperative delirium per person) of postoperative delirium on postoperative days 1, 2, and 3.
RESULTS


A total of 209 participants (71.2±6.7 years old, 29.2% male) were included in the final data analysis. The incidence of postoperative delirium was 33.0% with propofol anesthesia and 23.3% with sevoflurane anesthesia (p = 0.119, Chi-square test), and we estimated that we would need 316 participants in each arm to detect a potential statistically significant difference. Days of postoperative delirium per person were higher in the propofol (0.5±0.8) anesthesia group compared to the sevoflurane anesthesia group (0.3±0.5, p = 0.049, Student's t-test).
CONCLUSION


This pilot study established a system to compare effects of different anesthetics and generated a hypothesis that propofol trended to have a higher incidence and had longer duration of postoperative delirium than sevoflurane. Additional studies with a larger sample size are needed to test this hypothesis.",2020,"Days of postoperative delirium per person were higher in the propofol (0.5±0.8) anesthesia group compared to the sevoflurane anesthesia group (0.3±0.5, p = 0.049, Student's t-test).
","['older patients who had surgery under the intravenous anesthetic propofol or the inhalational anesthetic sevoflurane', 'Older Patients', 'A total of 209 participants (71.2±6.7 years old, 29.2% male', 'Participants were patients who had total hip/knee replacements']","['propofol', 'sevoflurane', 'Propofol and Sevoflurane', 'sevoflurane anesthesia']","['Postoperative Delirium', 'incidence of postoperative delirium']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0242904', 'cui_str': 'General intravenous anesthetic'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",209.0,0.173944,"Days of postoperative delirium per person were higher in the propofol (0.5±0.8) anesthesia group compared to the sevoflurane anesthesia group (0.3±0.5, p = 0.049, Student's t-test).
","[{'ForeName': 'Xinchun', 'Initials': 'X', 'LastName': 'Mei', 'Affiliation': ""Department of Psychiatry, Shanghai Tenth People's Hospital, Anesthesia and Brain Research Institute, Tongji University School of Medicine, Shanghai, P. R. China.""}, {'ForeName': 'Hai-Lin', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': ""Department of Psychiatry, Shanghai Tenth People's Hospital, Anesthesia and Brain Research Institute, Tongji University School of Medicine, Shanghai, P. R. China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, P. R. China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Tongji University School of Medicine, Shanghai, P. R. China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Marcantonio', 'Affiliation': 'Divisions of General Medicine and Primary Care and Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Zhongcong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Geriatric Anesthesia Research Unit, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Psychiatry, Shanghai Tenth People's Hospital, Anesthesia and Brain Research Institute, Tongji University School of Medicine, Shanghai, P. R. China.""}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200322']
1395,32657920,Banded Versus Nonbanded Sleeve Gastrectomy: A Randomized Controlled Trial With 3 Years of Follow-up.,"OBJECTIVE


The aim of this study was to compare silicone-banded sleeve gastrectomy (BSG) to nonbanded sleeve gastrectomy (SG) regarding weight loss, obesity-related comorbidities, and complications.
SUMMARY BACKGROUND DATA


As a primary bariatric procedure, SG leads to excellent weight loss, yet weight regain is a relevant issue in mid- to long-term follow-up. Retrospective analyses suggest that banding a sleeve using a silicone ring may decrease weight regain and improve weight loss.
METHODS


The banded versus nonbanded sleeve gastrectomy single-center, randomized controlled trial was conducted from January 2015 to August 2019. The primary endpoint was defined as excess weight loss 3 years after surgery. Secondary endpoints included the surgery's impact on obesity-related comorbidities, quality of life, and complications. The study was registered under DRKS00007729.
RESULTS


Among 94 patients randomized, 97% completed 3-year follow-up. Mean initial body mass index was 50.9 kg/m [95% confidence interval (CI), 49.6-52.2]. Mean adjusted excess weight loss 3 years after SG amounted to 62.3% (95% CI, 56.2-68.5) and 73.9% ( 95% CI, 67.8-80.0) after BSG (difference 11.6%, P = 0.0073). Remission of type 2 diabetes occurred in 66.7% (4/6) after SG and in 91.0% (10/11) following BSG (P = 0.21). Three years after surgery, ring implantation correlated with decreased frequency of symptomatic reflux episodes (P = 0.01) but increased frequency of regurgitation (P = 0.03). The rate of major complications was not different between the study groups (BSG, n = 3; SG, n = 2; P = 0.63). Quality of life was better following BSG (P = 0.001).
CONCLUSIONS


BSG provided better weight loss than nonbanded SG 3 years after surgery. Regurgitation was the main clinically relevant negative effect after BSG.",2020,"Quality of life was better following BSG (P = 0.001).
","['94 patients randomized, 97% completed 3-year follow-up']","['banded versus nonbanded sleeve gastrectomy single-center', 'Banded Versus Nonbanded Sleeve Gastrectomy', 'silicone-banded sleeve gastrectomy (BSG', 'nonbanded sleeve gastrectomy (SG']","['Remission of type 2 diabetes', 'frequency of symptomatic reflux episodes', 'Mean initial body mass index', 'weight regain and improve weight loss', 'Mean adjusted excess weight loss 3 years after SG', 'frequency of regurgitation', 'weight loss', ""surgery's impact on obesity-related comorbidities, quality of life, and complications"", 'excess weight loss 3 years after surgery', 'Quality of life', 'rate of major complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",94.0,0.15993,"Quality of life was better following BSG (P = 0.001).
","[{'ForeName': 'Jodok M', 'Initials': 'JM', 'LastName': 'Fink', 'Affiliation': 'Department of General and Visceral Surgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hetzenecker', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': ''}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Runkel', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Laessle', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fichtner-Feigl', 'Affiliation': ''}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Marjanovic', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004174']
1396,32654257,Improving Follow-up Attendance for Discharged Emergency Care Patients Using Automated Phone System to Self-schedule: A Randomized Controlled Trial.,"BACKGROUND


Automated phone appointment reminders have improved adherence with follow-up appointments in a variety of hospital settings, but have mixed results in patients discharged from the emergency department (ED). Increasing adherence to follow-up care has been a priority in the ED to improve patient outcomes and reduce unnecessary future visits.
METHODS


We conducted a prospective randomized open, blinded end-point (PROBE) trial of 278 adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard-of-care written instructions to contact listed referral providers. The primary outcome was time to appointment. The secondary outcome was time to return visit to the ED.
RESULTS


The automated reminders increased the cumulative incidence of keeping the referral appointment after ED discharge (p < 0.001, Gray's test). Of participants randomized to the automated phone intervention, 49.3% (n = 74) kept their follow-up appointment versus 23.4% (n = 30) in the control arm, with a hazard ratio (HR) and 95% confidence interval (CI) over the duration of the study period of 2.4 (1.6 to 3.7; p < 0.001). In a sensitivity analysis using 30 days of follow-up data, 42.0% (n = 63) of participants randomized to the phone intervention kept their follow-up versus 21.1% (n = 27) in the control arm, with a HR (95% CI) of 2.2 (1.4 to 3.5; p < 0.001). There was no difference in ED revisits between the intervention and control group within 120 days postdischarge.
CONCLUSIONS


An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.",2020,"An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.","['278 adult patients discharged from the ED and referred to a provider for follow-up care', 'patients discharged from the emergency department (ED', 'Discharged Emergency Care Patients']",['self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders'],"['cumulative incidence of keeping the referral appointment after ED discharge', 'time to return visit to the ED', 'ED revisits', 'time to appointment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",278.0,0.137672,"An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.","[{'ForeName': 'Kyla L', 'Initials': 'KL', 'LastName': 'Bauer', 'Affiliation': 'From the, School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Omolade O', 'Initials': 'OO', 'LastName': 'Sogade', 'Affiliation': 'From the, School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'Gage', 'Affiliation': 'General Medical Sciences, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Ruoff', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Lawrence M', 'Initials': 'LM', 'LastName': 'Lewis', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine, Washington University, St. Louis, MO, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14080']
1397,32654447,[Analysis of the safety and efficacy of bronchial thermoplasty for severe asthma with the first second forced expiratory volume (FEV(1)) as a percentage of the predicted value (FEV(1)%pred)<60].,"Objective:  To investigate the efficacy and safety of bronchial thermoplasty (BT) in severe asthma patients with the first second forced expiratory volume (FEV(1)) as a percentage of the predicted value (FEV(1)%pred) <60%.  Methods:  A retrospective analysis was performed on 75 patients with asthma who were treated with BT at Shenzhen University Hospital of the Chinese Academy of Sciences from January 2016 to January 2018. The patients were divided into two groups based on the FEV(1)%pred before treatment: FEV(1)%pred <60% group (39 cases) and FEV(1)%pred ≥60% group (36 cases). Comparative analysis of glucocorticoid consumption, times of acute attack, asthma control test (ACT) score, changes in lung function, and adverse reactions at 3 weeks after treatment were performed between the two groups of patients.  Results:  Before BT treatment, the consumption of oral prednisone, the amount of budesonide inhaled, and the times of acute attack [ M  ( Q (1),  Q (3))] in the FEV(1)%pred <60% group were significantly greater than those in the FEV(1)%pred ≥60% group, and the ACT score was significantly lower than the FEV(1)%pred ≥60% group [10.00 (0, 20.00) vs 0(0, 3.75) mg/d, 960 (320, 960) vs 320 (320, 640) μg/d, 5(4, 8) vs 4 (4, 5) times/year, 13 (9, 15) vs 17 (13, 19) scores] (all  P< 0.05). Except that the oral prednisone dosage in the FEV(1)%pred<60% group was still higher 1 year after treatment [0 (0, 5.00) vs 0 (0, 0) mg/d] ( P= 0.009), there was no significant difference in the remaining indicators between the two groups 1 year after treatment and 2 years after treatment (all  P> 0.05). After 1 year and 2 years of treatment, all indicators in the two groups were better than before treatment (all  P< 0.05). The inhaled budesonide amount and the times of acute exacerbation in the FEV(1)%pred <60% group 2 years after treatment were less than those 1 year after treatment [320 (320, 320) vs 320 (320, 640) μg/d, 0 (0, 0) vs 0(0, 1) times/year] (all  P< 0.05), and there was no significant difference in the remaining indicators. In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05). In the FEV(1)%pred <60% group, FEV(1) and the FEV(1)%pred were significantly lower than the FEV(1)%pred ≥60% group before treatment, 1 year after treatment and 2 years after treatment [FEV(1):(1.21±0.41) vs (2.26±0.80)L, (1.84±0.73) vs (2.30±0.78)L, (1.70±0.66) vs (2.38±0.76)L; FEV(1)%pred:46.2 (38.5, 53.7)% vs 80.8(66.5, 93.6)%, 60.1 (48.2, 71.6)% vs 87.4 (68.5, 96.5)%, 58.5 (48.6, 74.8)% vs 86.6 (73.0, 97.3)%] (all  P< 0.05). In the FEV(1)%pred <60% group, FEV(1) and FEV(1)%pred 1 year after treatment and 2 years after treatment were all increased compared with before treatment (all  P< 0.05). In the FEV(1)%pred ≥60% group, there was no statistical difference in FEV(1) at each time point before and after treatment (all  P> 0.05), but the FEV(1)%pred at 2 years after treatment was higher than before treatment ( P< 0.05). There were no significant differences in adverse events between the two groups (all  P> 0.05).  Conclusion:  BT can significantly improve the lung function, reduce the times of acute attack and the dosage of glucocorticoids in severe asthma patients with FEV(1)% pred<60%, which is safe and effective.",2020,"In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05).","['75 patients with asthma who were treated with BT at Shenzhen University Hospital of the Chinese Academy of Sciences from January 2016 to January 2018', 'severe asthma patients with the first second forced expiratory volume (FEV(1']","['bronchial thermoplasty (BT', 'BT', 'FEV(1)%pred']","['acute exacerbation', 'FEV(1', 'FEV(1)%pred', 'consumption of oral prednisone, the amount of budesonide inhaled, and the times of acute attack [ M  ( Q (1),  Q (3', 'lung function', 'adverse events', 'ACT score', 'glucocorticoid consumption, times of acute attack, asthma control test (ACT) score, changes in lung function, and adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]","[{'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",75.0,0.0274246,"In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200119-00127']
1398,32659437,Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods.,"Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. The objective of the On The Move randomized controlled trial is to test the effectiveness of a linguistically and culturally targeted SMS PA intervention (SMS PA Advisor) versus two comparison conditions: a) a standard, staff-delivered phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention to promote a healthy diet (SMS Nutrition Advisor). The study sample (N = 350) consists of generally healthy, insufficiently active Latino adults ages 35 years and older living in five northern California counties. Study assessments occur at baseline, 6, and 12 months, with a subset of participants completing 18-month assessments. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields. Trial Registration: clinicaltrial.gov Identifier = NCT02385591.",2020,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"['Latino population', 'The study sample (N\u202f=\u202f350) consists of generally healthy, insufficiently active Latino adults ages 35\u202fyears and older living in five northern California counties']","['phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention', 'linguistically and culturally targeted SMS PA intervention (SMS PA Advisor', 'Text messaging (SMS', 'physical activity advice delivered via text messaging vs. human phone advisors']","['12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0964757,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"[{'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Epidemiology & Population Health, Stanford University School of Medicine, Stanford, CA 94305, United States of America; Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: king@stanford.edu.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Campero', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: icampero@stanford.edu.'}, {'ForeName': 'Jylana L', 'Initials': 'JL', 'LastName': 'Sheats', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: JSheats@tulane.edu.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Castro Sweet', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: cynthia@omadahealth.com.'}, {'ForeName': 'Patricia Rodriguez', 'Initials': 'PR', 'LastName': 'Espinosa', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: prespinosa@stanford.edu.'}, {'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dgarcia3@stanford.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hauser', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mehauser@stanford.edu.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Done', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mdone@stanford.edu.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Patel', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: michele.patel@stanford.edu.'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Parikh', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: nparikh@caremessage.org.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Corral', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: ccorral@caremessage.org.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Ahn', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dahn@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106084']
1399,32659480,Effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia: A randomized controlled trial.,"PURPOSE


The present study aimed to assess the effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia.
METHODS


Thirty-four participants with behavioral dysphonia were randomly assigned to one of two treatment groups: 1) voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program only (n=14). Laryngoscopic assessment was performed in all subjects. Before and after voice therapy, participants underwent aerodynamic, electroglottographic, and acoustic assessment. The Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE). Comparison for all variables were performed between experimental group and control group.
RESULTS


Wilcoxon test showed significant improvements for experimental group for VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase). Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
CONCLUSION


Physiologic voice therapy based on semioccluded vocal tract exercises seems to be an effective tool to improve voice in subjects diagnosed with behavioral dysphonia. Apparently, most changes should be expected in variables related to physical and functional aspects compared to objective variables. Subglottic pressure and phonation threshold pressure seem to be the most change-sensitive parameters and they may reflect a reduction in phonatory effort reported by patients after voice therapy.",2020,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","['subjects diagnosed with behavioral dysphonia', 'Thirty-four participants with behavioral dysphonia', 'subjects with behavioral dysphonia']","['physiologic voice therapy program', 'phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE', 'voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program', 'Physiologic voice therapy']","['VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase', 'Subglottic pressure and phonation threshold pressure', 'Laryngoscopic assessment', 'Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality', 'subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",34.0,0.0112718,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile; Department of Otolaryngology, Las Condes Clinic, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bertucci', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: terebertucci@gmail.com.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Pacheco', 'Affiliation': 'Department of Otolaryngology, Las Condes Clinic, Av. Estoril 850, Santiago, Chile. Electronic address: cpachecob@clinicalascondes.cl.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leiva', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad Pedro de Valdivia, Vicuña Mackena 44, Santiago, Chile. Electronic address: fernando.leiva.solari@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Quintana', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: quintana.b.felipe@gmail.com.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Ansaldi', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad de las Américas, Santiago, Chile. Electronic address: romina.ansaldi@gmail.com.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: cequezad@uc.cl.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Department of Otolaryngology, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: daniel.uchile@gmail.com.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106023']
1400,32659919,A Gluten-Free Meal Produces a Lower Postprandial Thermogenic Response Compared to an Iso-Energetic/Macronutrient Whole Food or Processed Food Meal in Young Women: A Single-Blind Randomized Cross-Over Trial.,"Consumption of ultra-processed food (PF) is associated with obesity risk compared with whole food (WF) intake. Less is known regarding the intake of gluten-free (GF) food products. The purpose of this study was to directly compare the thermic effect (TEM), substrate utilization, hunger/taste ratings, and glucose response of three different meals containing PF, WF, and GF food products in young healthy women. Eleven volunteers completed all three iso-caloric/macronutrient test meals in a single-blind, randomized crossover design: (1) whole food meal (WF); (2) processed food meal (PF); or (3) gluten-free meal (GF). TEM was significantly lower following GF compared with WF (-20.94 kcal/meal, [95% CI, -35.92 to -5.96],  p  = 0.008) and PF (mean difference: -14.94 kcal/meal, [95% CI, -29.92 to 0.04],  p  = 0.04), respectively. WF consumption resulted in significantly higher feelings of fullness compared to GF (mean difference: +14.36%, [95% CI, 3.41 to 25.32%],  p  = 0.011) and PF (mean difference: +16.81%, [95% CI, 5.62 to 28.01%],  p  = 0.004), respectively, and enhanced palatability (taste of meal) compared to PF meal (mean Δ: +27.41%, [95% CI, 5.53 to 49.30%],  p  = 0.048). No differences existed for substrate utilization and blood glucose response among trials. Consumption of a GF meal lowers postprandial thermogenesis compared to WF and PF meals and fullness ratings compared to a WF meal which may impact weight control and obesity risk over the long-term.",2020,"WF consumption resulted in significantly higher feelings of fullness compared to GF (mean difference: +14.36%, [95% CI, 3.41 to 25.32%],  p  = 0.011) and PF (mean difference: +16.81%, [95% CI, 5.62 to 28.01%],  p  = 0.004), respectively, and enhanced palatability (taste of meal) compared to PF meal (mean Δ: +27.41%, [95% CI, 5.53 to 49.30%],  p  = 0.048).","['Eleven volunteers', 'young healthy women', 'Young Women']","['whole food meal (WF); (2) processed food meal (PF); or (3) gluten-free meal (GF', 'ultra-processed food (PF', 'GF meal', 'Energetic/Macronutrient Whole Food or Processed Food Meal']","['substrate utilization and blood glucose response', 'Postprandial Thermogenic Response', 'TEM', 'PF', 'feelings of fullness', 'enhanced palatability (taste of meal', 'fullness ratings', 'postprandial thermogenesis', 'thermic effect (TEM), substrate utilization, hunger/taste ratings, and glucose response']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",11.0,0.0721658,"WF consumption resulted in significantly higher feelings of fullness compared to GF (mean difference: +14.36%, [95% CI, 3.41 to 25.32%],  p  = 0.011) and PF (mean difference: +16.81%, [95% CI, 5.62 to 28.01%],  p  = 0.004), respectively, and enhanced palatability (taste of meal) compared to PF meal (mean Δ: +27.41%, [95% CI, 5.53 to 49.30%],  p  = 0.048).","[{'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Dioneda', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Healy', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Sheridan', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Alex E', 'Initials': 'AE', 'LastName': 'Mohr', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85281, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Arciero', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]",Nutrients,['10.3390/nu12072035']
1401,32660977,"Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52.","OBJECTIVES


SPIRIT head-to-head (H2H) is a 52-week (Wk) trial comparing ixekizumab (IXE) with adalimumab (ADA) for simultaneous American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 responses in 566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA). IXE was superior to ADA for this primary end point at Wk24. We aimed to determine the final efficacy and safety results through Wk52 including a prespecified subgroup analysis of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use.
METHODS


SPIRIT-H2H is a Wk52 multicentre, open-label, blinded-assessor study comparing IXE and ADA in bionaïve patients with PsA. Patients were randomised 1:1 to IXE or ADA with stratification by concomitant csDMARD use and presence of moderate-to-severe plaque psoriasis. Prespecified end points at Wk24 and Wk52 included musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety.
RESULTS


A significantly higher proportion of patients treated with IXE versus ADA simultaneously achieved ACR50 and PASI100 (39% vs 26%, p<0.001), PASI100 (64% vs 41%, p<0.001) at Wk52. Efficacy of IXE and ADA was similar at Wk52 for ACR50 (49.8% vs 49.8%, p=0.924), treat-to-target outcomes, enthesitis and dactylitis resolution. Responses to IXE were consistent irrespective of concomitant csDMARD use. Significantly more patients on IXE monotherapy versus ADA monotherapy had simultaneous ACR50 and PASI100 (38% vs 19%, p=0.007), and PASI100 responses (66% vs 35%, p<0.001) at Wk52. There were no new safety findings for IXE or ADA.
CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations. IXE efficacy was consistent irrespective of concomitant csDMARD use.
TRIAL REGISTRATION NUMBER


NCT03151551.",2020,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","['566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA', 'bionaïve patients with PsA. Patients', 'patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug']","['IXE or ADA', 'conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD', 'IXE', 'ixekizumab (IXE) with adalimumab (ADA', 'ixekizumab versus adalimumab', 'IXE and ADA']","['simultaneous ACR50 and PASI100', 'musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety', 'simultaneous joint and skin improvement', 'IXE efficacy', 'PASI100 responses', 'efficacy and safety', 'ACR50 and PASI100']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0954263,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria josef.smolen@meduniwien.ac.at.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Providence St Joseph Health, Rentton, Washington, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'de la Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lingnan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Hojnik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sapin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': ""Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Caporali', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, G. Pini Hospital, Milan, Lombardia, Italy.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Rheumatology Department, Hospital Universitario Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology, Regional University Hospital Centre Tours, Tours, Centre, France.'}, {'ForeName': 'Soyi', 'Initials': 'S', 'LastName': 'Liu Leage', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sreekumar', 'Initials': 'S', 'LastName': 'Pillai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Gold Coast, Queensland, Australia.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217372']
1402,32661006,A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19.,"To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively,  P  = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively,  P  = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.).",2020,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","['Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications ', 'severe COVID-19', 'Between 29 th  February to 3 rd  April 2020, 92 patients were recruited that finally 42 patients in the IFN group and 39 patients in the control group completed the study', 'patients with severe COVID-19']","['hydroxychloroquine plus lopinavir/ritonavir or atazanavir/ritonavir', 'IFN β-1a', 'IFN', 'interferon β-1a']","['reduced mortality', 'time to the clinical response', 'Efficacy and safety', 'duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization', 'time to reach clinical response', '28-day mortality', 'discharge rate', '28-day overall mortality']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",92.0,0.186626,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","[{'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran Khalilih@sina.tums.ac.ir.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Abbasian', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kazemzadeh', 'Affiliation': 'Advanced Thoracic Research Center, Occupational Sleep Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01061-20']
1403,32658939,Minimal transmission in an influenza A (H3N2) human challenge-transmission model within a controlled exposure environment.,"Uncertainty about the importance of influenza transmission by airborne droplet nuclei generates controversy for infection control. Human challenge-transmission studies have been supported as the most promising approach to fill this knowledge gap. Healthy, seronegative volunteer 'Donors' (n = 52) were randomly selected for intranasal challenge with influenza A/Wisconsin/67/2005 (H3N2). 'Recipients' randomized to Intervention (IR, n = 40) or Control (CR, n = 35) groups were exposed to Donors for four days. IRs wore face shields and hand sanitized frequently to limit large droplet and contact transmission. One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure. The main difference between these studies was mechanical building ventilation in the follow-on study, suggesting a possible role for aerosols.",2020,"One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure.","[""Healthy, seronegative volunteer 'Donors' (n = 52""]",['intranasal challenge with influenza A/Wisconsin/67/2005 (H3N2). '],[],"[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}]",[],52.0,0.0134321,"One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure.","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Nguyen-Van-Tam', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Killingley', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enstone', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hewitt', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Jovan', 'Initials': 'J', 'LastName': 'Pantelic', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Grantham', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'P Jacob', 'Initials': 'PJ', 'LastName': 'Bueno de Mesquita', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lambkin-Williams', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gilbert', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mann', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Forni', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Noakes', 'Affiliation': 'University of Leeds School of Civil Engineering, Leeds, United Kingdom.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'LaShondra', 'Initials': 'L', 'LastName': 'Berman', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lindstrom', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cauchemez', 'Affiliation': 'Imperial College London, MRC Centre for Outbreak Analysis and Modelling, Department of Infectious Disease Epidemiology, London, United Kingdom.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Bischoff', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tellier', 'Affiliation': 'McGill University, Dept of Medicine, Montreal, Canada.'}, {'ForeName': 'Donald K', 'Initials': 'DK', 'LastName': 'Milton', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS pathogens,['10.1371/journal.ppat.1008704']
1404,32659482,Transcranial random noise stimulation is more effective than transcranial direct current stimulation for enhancing working memory in healthy individuals: Behavioural and electrophysiological evidence.,"BACKGROUND


Transcranial direct current stimulation (tDCS) has been shown to improve working memory (WM) performance in healthy individuals, however effects tend to be modest and variable. Transcranial random noise stimulation (tRNS) can be delivered with a direct-current offset (DC-offset) to induce equal or even greater effects on cortical excitability than tDCS. To-date, no research has directly compared the effects of these techniques on WM performance or underlying neurophysiological activity.
OBJECTIVE


To compare the effects of anodal tDCS, tRNS + DC-offset, or sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) on WM performance and task-related EEG oscillatory activity in healthy adults.
METHODS


Using a between-subjects design, 49 participants were allocated to receive either anodal tDCS (N = 16), high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC. Changes in WM performance were assessed using the Sternberg WM task completed before and 5- and 25-min post-stimulation. Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity was analysed from EEG recorded during WM encoding and maintenance.
RESULTS


tRNS induced more pronounced and consistent enhancements in WM accuracy when compared to both tDCS and sham stimulation. Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
CONCLUSIONS


These findings demonstrate the potential of tRNS + DC-offset to modulate cognitive and electrophysiological measures of WM and raise the possibility that tRNS + DC-offset may be more effective and reliable than tDCS for enhancing WM performance in healthy individuals.",2020,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","['49 participants', 'healthy individuals', 'healthy adults', 'Healthy Individuals']","['Transcranial direct current stimulation (tDCS', 'high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC', 'anodal tDCS', 'tDCS', 'Transcranial random noise stimulation (tRNS', 'Transcranial Direct Current Stimulation', 'Transcranial Random Noise Stimulation', 'anodal tDCS, tRNS + DC-offset, or sham stimulation']","['WM performance and task-related EEG oscillatory activity', 'Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity', 'Changes in WM performance', 'working memory (WM) performance', 'WM accuracy', 'theta ERS and diminished gamma ERD', 'WM performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",49.0,0.0357647,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","[{'ForeName': 'O W', 'Initials': 'OW', 'LastName': 'Murphy', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Central Clinical School, The Alfred and Monash University, Melbourne, Australia; Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: oscar.murphy@monash.edu.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: kate.hoy@monash.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia. Electronic address: d.wong@latrobe.edu.au.'}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Bailey', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: neil.bailey@monash.edu.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: paul.fitzgerald@monash.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Segrave', 'Affiliation': 'Brain and Mental Health Research Hub, School of Psychological Sciences and Monash Biomedical Imaging, Monash Institute of Cognitive and Clinical Neuroscience, Monash University, Clayton, Australia. Electronic address: rebecca.segrave@monash.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.07.001']
1405,32659483,Non-invasive vagal nerve stimulation decreases brain activity during trauma scripts.,"BACKGROUND


Traumatic stress can have lasting effects on neurobiology and result in psychiatric conditions such as posttraumatic stress disorder (PTSD). We hypothesize that non-invasive cervical vagal nerve stimulation (nVNS) may alleviate trauma symptoms by reducing stress sympathetic reactivity. This study examined how nVNS alters neural responses to personalized traumatic scripts.
METHODS


Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study. In three sequential time blocks, personalized traumatic scripts were presented to participants immediately followed by either sham stimulation (n = 8; 0-14 V, 0.2 Hz, pulse width = 5s) or active nVNS (n = 11; 0-30 V, 25 Hz, pulse width = 40 ms). Brain activity during traumatic scripts was assessed using High Resolution Positron Emission Tomography (HR-PET) with radiolabeled water to measure brain blood flow.
RESULTS


Traumatic scripts resulted in significant activations within the bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen. Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate. During the first exposure to the trauma scripts, greater activations were found in the motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations were more predominant with later script presentations for those subjects receiving sham stimulation.
CONCLUSION


nVNS decreases neural reactivity to an emotional stressor in limbic and other brain areas involved in stress, with changes over repeated exposures suggesting a shift from scene appraisal to cognitively processing the emotional event.",2020,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.",['Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study'],"['invasive cervical vagal nerve stimulation (nVNS', 'active nVNS', 'nVNS']","['bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen', 'motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations', 'Greater activation', 'Brain activity']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",19.0,0.0708328,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: mattwittbrodt@emory.edu.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Minxuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Pearce', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Zuhayr S', 'Initials': 'ZS', 'LastName': 'Alam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Rapaport', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Murrah', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ammer A', 'Initials': 'AA', 'LastName': 'Haffer', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Shallenberger', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA; Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.002']
1406,32659637,Cost and cost-effectiveness of three strategies for implementing motivational interviewing for substance misuse on medical inpatient units.,"BACKGROUND


This study conducted cost and cost-effectiveness analyses of three strategies for implementing motivational interviewing for substance misuse on general medical inpatient units: workshop, apprenticeship, and consult.
METHODS


The economic analyses were conducted prospectively alongside a type 3 hybrid effectiveness-implementation randomized trial comprising 38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts. The trial took place in a university affiliated teaching hospital in New Haven, CT, USA. After completing a 1-day workshop on motivational interviewing, providers were randomized to conditions. The primary outcome measure was the number of study-eligible patients who received a motivational interview. The economic analyses included the costs of both start-up and on-going activities in each condition. Incremental cost-effectiveness ratios were used to determine cost effectiveness. Results are presented from the healthcare provider (i.e., hospital) perspective in 2018 US dollars.
RESULTS


The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively. Workshop and apprenticeship were extended dominated by the combination of consult and doing nothing. Doing nothing is cost effective when the willingness-to-pay for an additional patient receiving a motivational interview is less than $185.65, and consult is cost-effective when the willingness-to-pay for an additional patient receiving a motivational interview is greater than $185.65.
CONCLUSIONS


Given that typical reimbursements for brief intervention services for substance misuse are $35-$65, none of the three implementation strategies is likely to be economically viable from the healthcare provider perspective.",2020,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","['substance misuse on medical inpatient units', '38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts', 'university affiliated teaching hospital in New Haven, CT, USA']",['implementing motivational interviewing'],"['Cost and cost-effectiveness', 'Incremental cost-effectiveness ratios', 'total cost per patient receiving a motivational interview']","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",38.0,0.0294972,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'The University of Texas at Austin, Lyndon B. Johnson School of Public Affairs, Sid Richardson Hall, Unit 3, Austin, TX, 78712, USA. Electronic address: tolmstead@austin.utexas.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; Yale School of Medicine, Department of Obstetrics, Gynecology & Reproductive Sciences, 333 Cedar Street, New Haven, CT, 06510, USA; Yale School of Epidemiology and Public Health Division of Chronic Disease, 60 College Street, New Haven, CT, 06520, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; VA Connecticut Healthcare System, Psychology Service, 950 Campbell Avenue (116B), West Haven, CT, 06516, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108156']
1407,32663660,"Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.","BACKGROUND


Current guidelines recommend anticoagulation therapy during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, whether anticoagulation should be continued after pPCI has not been well investigated.
METHODS/DESIGN


The RIGHT trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure. Patients are randomized in a 1:1 fashion to receive either prolonged anticoagulant or matching placebo (no anticoagulation) for at least 48 hours after the procedure. When randomized to anticoagulation prolongation, the patient is assigned to intravenous unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin (same drug and same regimen at each center). The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The primary safety endpoint is major bleeding (BARC 3-5) at 30 days. Based on a superiority design and assuming a 35% relative risk reduction (from 7% to 4.5%), 2856 patients will be enrolled, accounting for a 5% drop-out rate (α = 0.05 and power = 80%).
CONCLUSION


The RIGHT trial tests the hypothesis that post-procedural anticoagulation is superior to no anticoagulation in reducing ischemic events in STEMI patients undergoing pPCI.",2020,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","['STEMI patients undergoing pPCI', 'STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure', 'after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction']","['prolonged anticoagulant or matching placebo (no anticoagulation', 'unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin', 'anticoagulation prolongation versus no anticoagulation', 'placebo']","['composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel', 'major bleeding (BARC 3-5', 'ischemic events']","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",2856.0,0.600901,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: eva3321@sina.com.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spaceeye123@126.com.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Beijing Luhe Hospital, Capital Medical University, Beijing, China. Electronic address: guojcmd@126.com.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Hospital of Hebei Medical University, Shijiazhuang, China. Electronic address: lyjbs2009@yeah.net.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ai', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: aihui0814@126.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: tjmusky@126.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Que', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: quebin@sohu.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhen', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: 13439546840@yeah.net.'}, {'ForeName': 'Jiapeng', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: jiapeng.lu@fwoxford.org.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: chshma@vip.sina.com.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Nie', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spnie@ccmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.06.005']
1408,32664643,Effects of 6 Weeks Direct Instruction and Teaching Games for Understanding Programs on Physical Activity and Tactical Behaviour in U-12 Soccer Players.,"The purpose of this study was to compare the effects of 6 weeks direct instruction and teaching games for understanding (TGfU) programs on the decision-making and execution (post-interventions), as well, as on the physical activity (PA) levels during sessions. Thirty under-12 football players participated in this study (age: 10.3 ± 0.45 years) and were randomly assigned to TGfU ( n  = 15) or direct instruction ( n  = 15) group. Two sessions/week were implemented. Results revealed that TGfU promoted higher levels ( p  = 0.043; d = 2.99) of light PA (28.96%) compared with direct instruction (27.55%). Non-significant higher sedentary PA levels ( p  = 0.073; d = 2.62) were found in the control group (35.48%). In terms of tactical principles, conservation of the ball increased the percentage of moderate to vigorous physical activity in TGfU (43.60%) compared with direct instruction (38.05%). According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2). TGfU seems to be more appropriate than direct instruction to increase the light PA levels during sessions while no significant differences were found between programs in moderate and vigorous intensities. Regarding the effects of programs in decisions, greater improvements in decisions with the ball were found in TGFU compared to DI.",2020,"According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2).","['Thirty under-12 football players participated in this study (age: 10.3 ± 0.45 years', 'U-12 Soccer Players']","['TGfU', '6 Weeks Direct Instruction and Teaching Games', 'direct instruction']","['light PA levels', 'Physical Activity and Tactical Behaviour', 'sedentary PA levels', 'physical activity (PA) levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]",,0.01403,"According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2).","[{'ForeName': 'Juan Vicente', 'Initials': 'JV', 'LastName': 'Sierra-Ríos', 'Affiliation': 'Physical Education Department, Faculty of Education, University of Castilla-La Mancha, 16071 Cuenca, Spain.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Rey', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Sixto', 'Initials': 'S', 'LastName': 'González-Víllora', 'Affiliation': 'Physical Education Department, Faculty of Education, University of Castilla-La Mancha, 16071 Cuenca, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17145008']
1409,32671131,Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19.,"Background


We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients.
Methods


In this single-center, randomized, and open-label trial, mild patients with polymerase chain reaction (PCR)-confirmed COVID-19 were enrolled in Shanghai, China. Participants were randomized to receive DRV/c for 5 days on the top of interferon alpha 2b inhaling or interferon alpha 2b inhaling alone. The primary end point was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population (clinicaltrials.gov: NCT04252274).
Results


From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2 ± 2.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment. The participants were randomized (range) at 4 (2-5) days after onset of symptoms. The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups ( P  = .72), respectively. The viral clearance rate at day 3 was 20% (3/15) in both study groups, while the number increased to 26.7% (4/15) in the DRV/c group and remained 20% (3/15) in the control group at day 5. Fourteen days after randomization, 1 participant in the DRV/c group progressed to critical illness and discontinued DRV/c, while all the patients in the control group were stable ( P  = 1.0). The frequencies of adverse events in the 2 groups were comparable.
Conclusions


Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.",2020,"The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups ( P  = .72), respectively.","['From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2\u2005±\u20052.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment', 'treating COVID-19 patients', 'mild patients with polymerase chain reaction (PCR)-confirmed COVID-19 were enrolled in Shanghai, China']","['interferon alpha 2b inhaling or interferon alpha 2b inhaling alone', 'darunavir/cobicistat (DRV/c']","['critical illness and discontinued DRV/c', 'virological clearance rate of oropharyngeal swabs', 'tolerated', 'Antiviral Activity and Safety', 'frequencies of adverse events', 'antiviral activity and safety', 'viral clearance rate', 'proportion of negative PCR results', 'proportion of negative conversion']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}]","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",30.0,0.211463,"The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups ( P  = .72), respectively.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Department of Tuberculosis, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Qingnian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Traditional Chinese Medicine, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Department of Infectious Diseases, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Tuberculosis, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Cardiovascular Diseases, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Shuibao', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Yingzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa241']
1410,32674461,Efficacy and Safety of the Combination of Pravastatin and Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (ESTAHEP Clinical Trial).,"Pravastatin has demonstrated anti-tumor activity in preclinical and clinical studies. This multicentric randomized double-blind placebo-controlled phase II study (NCT01418729) investigated the efficacy and safety of sorafenib + pravastatin combination on the overall survival (OS) and time to progression (TTP) of patients with advanced hepatocellular carcinoma (aHCC). A total of 31 patients were randomized. Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group). Of note, however, the radiological TTP was higher in patients treated with sorafenib + pravastatin than in the control group (9.9 months vs. 3.2 months;  p  = 0.008). Considering all the study population, the presence of portal vein thrombosis (PVT) was associated with worse OS, being lower in patients with PVT compared to patients without PVT (6.3 months vs. 14.8 months;  p  = 0.026). Data also showed a decrease in OS in patients with vascular invasion (VI) compared to patients who did not present it (6.3 months vs. 14.8 months;  p  = 0.041). The group of patients without dermatological events (DE) showed lower OS (6.9 months vs. 14.5 months;  p  = 0.049). In conclusion, combination of sorafenib + pravastatin was safe and well-tolerated, prolonging the TTP of patients with aHCC but not improving the OS compared to sorafenib + placebo. The absence of PVT and VI and the development of DE are positive prognostic factors of sorafenib response.",2020,Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group).,"['31 patients were randomized', 'patients with advanced hepatocellular carcinoma (aHCC']","['sorafenib + pravastatin combination', 'Pravastatin and Sorafenib', 'sorafenib + placebo', 'Pravastatin', 'sorafenib + pravastatin', 'placebo']","['Efficacy and Safety', 'Median OS', 'OS', 'radiological TTP', 'safe and well-tolerated', 'overall survival (OS) and time to progression (TTP', 'portal vein thrombosis (PVT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis'}]",31.0,0.0521069,Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group).,"[{'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Riaño', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Martín', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Varela', 'Affiliation': 'Digestive Service, Hepatology Unit, Asturias Central University Hospital, The University Institute of Oncology of Asturias (IUOPA), FINBA, 33006 Oviedo, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Serrano', 'Affiliation': 'Liver Unit, Lozano Blesa University Hospital-Aragon Health Research Institute, 50009 Zaragoza, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Núñez', 'Affiliation': 'Digestive Service, Infanta Sofía University Hospital, 28703 San Sebastián de los Reyes-Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mínguez', 'Affiliation': ""Liver Unit, Department of Medicine, Hospital Universitari Vall d'Hebron, Vall d´Hebron Institut of Research (VHIR), Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.""}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Perugorria', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Jesus M', 'Initials': 'JM', 'LastName': 'Banales', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Juan I', 'Initials': 'JI', 'LastName': 'Arenas', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}]",Cancers,['10.3390/cancers12071900']
1411,32675553,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2020,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', 'FRS) Skills Curriculum', '12 international American College of Surgeons (ACS']","['Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'dV-Trainer', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.173584,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
1412,32674419,Impact of an Educational Program on Behavioral Changes toward Environmental Health among Laotian Students.,"This study evaluates the effect of an integrated health care educational program on several behavioral changes related to environmental health among Laotian students. Students in the experimental group received education concerning environmental health-related issues, including air pollution and chemical exposure. Analyses of covariance (ANCOVA) and paired  t -tests were conducted for the statistical analysis of the pre- and post-survey scores. The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores. Moreover, in the experimental group, the girls' risk perception scores significantly increased after receiving the education, which was not observed in the control group. The risk perception score among non-drinking students also significantly increased after the program. These results indicate that the education program effectively enhanced the students' risk perception, especially that of girls and nondelinquent students.",2020,The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores.,"['Laotian Students', 'Laotian students']","['education concerning environmental health-related issues, including air pollution and chemical exposure', 'Educational Program', 'integrated health care educational program']","['risk perception score', 'risk perception and information-seeking behaviors towards air pollution and chemical exposure', ""students' risk perception"", ""girls' risk perception scores"", 'Behavioral Changes toward Environmental Health']","[{'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014413', 'cui_str': 'Health, Environmental'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0678803', 'cui_str': 'Chemical exposure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0596775', 'cui_str': 'Information Seeking Behavior'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0678803', 'cui_str': 'Chemical exposure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0014413', 'cui_str': 'Health, Environmental'}]",,0.0119297,The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores.,"[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Department of Occupational and Environmental Medicine, College of Medicine, Ewha Womans University, Seoul 07804, Korea.'}, {'ForeName': 'Harris Hyun-Soo', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Sociology, College of Social Sciences, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Eun Mee', 'Initials': 'EM', 'LastName': 'Kim', 'Affiliation': 'Department of International Studies, Graduate School of International Studies, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Yookyung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Kinesiology & Sports Studies, College of Science and Industry Convergence, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Ha', 'Affiliation': 'Department of Occupational and Environmental Medicine, College of Medicine, Ewha Womans University, Seoul 07804, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17145055']
1413,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1414,32661107,"Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA).","OBJECTIVE


Sulfonylureas are first-line treatment of hepatocyte nuclear factor 1-α (HNF1A) diabetes (maturity-onset diabetes of the young type 3), but many patients do not achieve optimal glycemic control without episodes of hypoglycemia. We investigated the combination of the sulfonylurea glimepiride and the dipeptidyl peptidase-4 inhibitor linagliptin versus glimepiride monotherapy with respect to glycemic variability, glycemic control, and risk of hypoglycemia.
RESEARCH DESIGN AND METHODS


In a randomized, double-blinded, crossover trial, patients with HNF1A diabetes ( n  = 19; mean ± SD age 43 ± 14 years, BMI 24.8 ± 2.8 kg/m 2 , and glycated hemoglobin [HbA 1c ] 7.4 ± 0.2% [57.1 ± 7.3 mmol/mol]) were randomly assigned to treatment with glimepiride + linagliptin 5 mg (16 weeks), washout (4 weeks), and glimepiride + placebo (16 weeks) (or vice versa). Glimepiride was titrated targeting a fasting plasma glucose of 4.5-6.0 mmol/L without hypoglycemia. Treatments were evaluated by continuous glucose monitoring (CGM), HbA 1c , and meal test.
RESULTS


Compared with glimepiride + placebo, glimepiride + linagliptin did not significantly improve the primary end point mean amplitude of glycemic excursions (MAGE) (mean difference -0.7 mmol/L,  P =  0.1540) but displayed significant reductions in coefficient of variation on CGM (-3.6%,  P =  0.0401), HbA 1c  (-0.5%,  P =  0.0048), and glimepiride dose (-0.7 mg/day,  P =  0.0099). β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin. Incidences of hypoglycemia were similar with both treatments.
CONCLUSIONS


Linagliptin as add-on treatment to glimepiride improved glycemic variability and control without increasing risk of hypoglycemia in patients with HNF1A diabetes.",2020,β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin.,"['patients with HNF1A diabetes ( n  = 19; mean ± SD age 43 ± 14 years, BMI 24.8 ± 2.8 kg/m 2 , and glycated hemoglobin', 'Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3', 'patients with HNF1A diabetes']","['Linagliptin', 'Placebo', 'sulfonylurea glimepiride and the dipeptidyl peptidase-4 inhibitor linagliptin versus glimepiride monotherapy', 'glimepiride + placebo, glimepiride + linagliptin', 'glimepiride', 'glimepiride + placebo', 'Glimepiride', 'glimepiride + linagliptin']","['Efficacy and Safety', 'continuous glucose monitoring (CGM), HbA 1c , and meal test', 'glycemic variability', 'Incidences of hypoglycemia', 'glycemic variability, glycemic control, and risk of hypoglycemia', 'β-cell glucose sensitivity', 'coefficient of variation on CGM', 'mean amplitude of glycemic excursions (MAGE', 'risk of hypoglycemia', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1451774', 'cui_str': 'HNF1A protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",,0.166354,β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin.,"[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Støy', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Kampmann', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Seghieri', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark t.vilsboll@dadlnet.dk.'}]",Diabetes care,['10.2337/dc20-0408']
1415,32661108,Effect of Afrezza on Glucose Dynamics During HCL Treatment.,"OBJECTIVE


A major obstacle in optimizing the performance of closed loop automated insulin delivery systems has been the delay in insulin absorption and action that results from the subcutaneous (SC) route of insulin delivery leading to exaggerated postmeal hyperglycemic excursions. We aimed to investigate the effect of Afrezza inhaled insulin with ultrafast-in and -out action profile on improving postprandial blood glucose control during hybrid closed-loop (HCL) treatment in young adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS


We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (A L ) and a high (A H ) dose as compared with a standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H  and down for A L ). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to 4 h after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics.
RESULTS


The mean ± SD PPG for the rapid-acting insulin control arm and A H  was similar (185 ± 50 mg/dL vs. 195 ± 46 mg/dL, respectively;  P  = 0.45), while it was higher for meals using A L  (208 ± 54 mg/dL,  P  = 0.04). The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
CONCLUSIONS


Afrezza (A H ) premeal bolus reduced the early glycemic excursion and improved PPG during HCL compared with aspart premeal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120 min.",2020,"The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
",['young adults with type 1 diabetes'],"['Afrezza', 'hybrid closed-loop (HCL', 'Afrezza inhaled insulin with ultrafast-in and -out action profile', 'standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment', 'premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H  and down for A L ']","['early PPG level', 'PPG', 'postprandial blood glucose control', 'mean ± SD PPG', 'efficacy and safety', 'early glycemic excursion and improved PPG', 'hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics', 'peak postprandial plasma glucose (PPG) level']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3834216', 'cui_str': 'Afrezza'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.101007,"The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Galderisi', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT alfonso.galderisi@yale.edu alfonso.galderisi@unipd.it.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kraemer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}]",Diabetes care,['10.2337/dc20-0091']
1416,32662327,"Do different sit-stand workstations influence lumbar kinematics, lumbar muscle activity and musculoskeletal pain in office workers? A secondary analysis of a randomized controlled trial.","Purpose.  This study investigated the effect of different sit-stand workstations on lumbar spine kinematics, lumbar muscle activity and musculoskeletal pain.  Methods.  Thirty-two office workers were randomized to one of three sit-stand workstations (Group 1, ratio of minutes spent sitting to standing each hour at work 40:20,  n  = 8; Group 2, 30:30,  n  = 6; Group 3, 20:40,  n  = 7) and a control group (usual sitting,  n  = 11). Intervention groups (Groups 1, 2 and 3) were collapsed into one group for analysis ( n  = 21). Data on lumbar kinematics and muscle activity were only collected for 25 participants due to equipment availability.  Results.  Participants in the intervention group had lower overall lumbar spine flexion angles during the workday compared to the control group (mean difference 10.6°; 95% confidence interval [-18.1, -3.2];  p  = 0.008; Cohen's  d  = 1.5). There were no between-group differences for the remaining kinematic measures (i.e., mean flexion angle in standing and sitting, mean side flexion angle in standing and sitting, and percentage of time in upright sitting), muscle activity or presence of musculoskeletal pain.  Conclusions.  Sit-stand workstations reduced overall lumbar spine flexion angles over the course of a workday but had no effect on other kinematic measures, lumbar spine muscle activity or musculoskeletal pain.  Trial registration:  Australian New Zealand Clinical Trials Registry identifier: ACTRN12615001018505..",2020,"had lower overall lumbar spine flexion angles during the workday compared to the control group (mean difference: 10.6°; 95% CI [-18.1, -3.2]; p=0.008; Cohen's d=1.5).","['Results:  Participants in the intervention group', 'Materials and methods:  Thirty-two office workers', '25 participants due to equipment availability']",['sit-stand workstations'],"['overall lumbar spine flexion angles', 'lumbar kinematics and muscle activity', 'lumbar kinematics, lumbar muscle activity and musculoskeletal pain', 'kinematic measures, lumbar spine muscle activity or musculoskeletal pain', 'lumbar spine kinematics, lumbar muscle activity and musculoskeletal pain', 'remaining kinematic measures (i.e. mean flexion angle in standing and sitting, mean side flexion angle in standing and sitting, and the percentage of time in upright sitting), muscle activity or the presence of musculoskeletal pain']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",25.0,0.081067,"had lower overall lumbar spine flexion angles during the workday compared to the control group (mean difference: 10.6°; 95% CI [-18.1, -3.2]; p=0.008; Cohen's d=1.5).","[{'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Australia.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Pappas', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Australia.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Foley', 'Affiliation': 'Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Zadro', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mackey', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Shirley', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Voukelatos', 'Affiliation': 'Health Promotion Unit, Sydney Local Health District, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Australia.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2020.1796039']
1417,32666826,Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals.,"BACKGROUND/AIMS


Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation.
METHODS


We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
RESULTS


Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4-96.7] and 89.8 [83.6-95.2], respectively;  P  = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3-46.3),  P  < 0.001.
CONCLUSION


Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.",2020,"Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
",[],['JAMA'],"['trial protocol adherence rate', 'Protocol adherence rates', 'median and interquartile protocol adherence rates']",[],[],"[{'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3.0,0.501073,"Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
","[{'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Bamat', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Osayame A', 'Initials': 'OA', 'LastName': 'Ekhaguere', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Lingqiao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Flannery', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Handley', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Herrick', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520941428']
1418,32665432,Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate.,"OBJECTIVES


Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment.
METHODS


Children aged 4-17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1).
RESULTS


Of 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
CONCLUSIONS


Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.",2020,"Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
","['Children aged 4-17\xa0years with polyarticular JIA', 'patients with polyarticular juvenile idiopathic arthritis receiving', 'patients with juvenile idiopathic arthritis (JIA', '171 patients enrolled, 62 (36%) completed the long-term extension']","['adalimumab with or without methotrexate', 'adalimumab', 'placebo']","['Mean JADAS27', 'clinical remission (JADAS27', 'efficacy assessments included JIA American College of Rheumatology (JIA ACR', '27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1', 'JIA ACR 30/50/70/90 responses and JADAS27 LDA', 'Adverse events (AEs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4521004', 'cui_str': 'Polyarticular juvenile idiopathic arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",11.0,0.208291,"Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lovell', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA Daniel.lovell@cchmc.org.""}, {'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Andreas O', 'Initials': 'AO', 'LastName': 'Reiff', 'Affiliation': 'Department of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Jung', 'Affiliation': ""Department of Rheumatology, Children's National Medical Center for Cancer and Immunology Research, Washington, District of Columbia, USA.""}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Jarosova', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Němcová', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mouy', 'Affiliation': 'Pediatric Rheumatology, Univeristé Paris-Descartes and Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Sandborg', 'Affiliation': ""Pediatric Rheumatology, Lucile Packard Children's Hospital at Stanford, Palo Alto, California, USA.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Bohnsack', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Pediatric Rheumatology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elewaut', 'Affiliation': 'Rheumatology, University Hospital Gent, Gent, Belgium.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Gabriel', 'Affiliation': ""Pediatric Rheumatology, Children's Hospital of the King's Daughters, Norfolk, Virginia, USA.""}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Higgins', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Kone-Paut', 'Affiliation': 'Department of Paediatric Rheumatology and CEREMAI, Hôpital De Bicêtre, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, Paris, France.'}, {'ForeName': 'Olcay Y', 'Initials': 'OY', 'LastName': 'Jones', 'Affiliation': 'Pediatric Rheumatology, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Vargová', 'Affiliation': 'Pediatric Rheumatology Unit, Faculty Hospital, Kosice, Slovakia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chalom', 'Affiliation': 'Pediatric-Rheumatology, Saint Barnabas Medical Center, Livingston, New Jersey, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Wouters', 'Affiliation': 'Pediatric Immunology, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lagunes', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI),, Università degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Clinica Pediatrica e Reumatologia-PRINTO, IRCCS Istituto Giannina Gaslini, Genova, Italy.'}]",RMD open,['10.1136/rmdopen-2020-001208']
1419,32665433,"Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study.","OBJECTIVE


To evaluate the effect of guselkumab on enthesitis and dactylitis in a phase II trial of patients with active psoriatic arthritis (PsA).
METHODS


This was a phase II, randomised, placebo-controlled, double-blind trial of adults with active PsA (≥3 swollen and ≥3 tender joints and C reactive protein ≥0.3 mg/dL) despite conventional synthetic disease-modifying anti-rheumatic drug, non-steroidal anti-inflammatory drug, and/or oral corticosteroid therapy. Patients were randomised to subcutaneous injections of guselkumab 100 mg or placebo at weeks 0, 4 and every 8 weeks, with placebo crossover to guselkumab at week 24. Dactylitis was scored on a scale of 0-3 on each digit; enthesitis was assessed using the Leeds Enthesitis Index (0-6). Other assessments included American College of Rheumatology (ACR) and Psoriasis Area and Severity Index responses.
RESULTS


Of 149 randomised patients, 107 patients had enthesitis (mean score=2.7) and 81 patients had dactylitis (mean dactylitis score=5.7) at baseline. Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56. Similar results were observed for the proportions of patients with resolution of enthesitis and dactylitis. At week 56, mean improvements in enthesitis and dactylitis among patients who switched from placebo to guselkumab treatment were similar to those in the guselkumab group. In the guselkumab group, ACR20 responders had greater improvements in enthesitis and dactylitis versus non-responders (week 24).
CONCLUSIONS


At week 24, the guselkumab group had greater mean improvements in enthesitis and dactylitis and greater proportions of patients with resolution of enthesitis and dactylitis versus placebo. ACR20 response was associated with improvements in enthesitis and dactylitis.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT02319759.URL: https://clinicaltrials.gov/ct2/show/NCT02319759; Registered 18 December 2014.",2020,Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56.,"['patients with moderate to severe psoriatic arthritis', 'Of 149 randomised patients, 107 patients had enthesitis (mean score=2.7) and 81 patients had dactylitis (mean dactylitis score=5.7) at baseline', 'adults with active PsA (≥3 swollen and ≥3 tender joints and C reactive protein ≥0.3 mg/dL) despite conventional synthetic disease-modifying anti-rheumatic drug, non-steroidal anti-inflammatory drug, and/or oral corticosteroid therapy', 'patients with active psoriatic arthritis (PsA']","['guselkumab', 'https://clinicaltrials.gov/ct2/show/NCT02319759', 'guselkumab 100 mg or placebo', 'NCT02319759.URL', 'placebo']","['American College of Rheumatology (ACR) and Psoriasis Area and Severity Index responses', 'enthesitis and dactylitis', 'resolution of enthesitis and dactylitis', 'ACR20 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}]",,0.345895,Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56.,"[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington, USA pmease@philipmease.com.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Dennis G', 'Initials': 'DG', 'LastName': 'McGonagle', 'Affiliation': 'Chapel Allerton Hospital, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Brisbane, Australia.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mt Sinai, NewYork, NewYork, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development LLC, La Jolla, California, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Chetan S', 'Initials': 'CS', 'LastName': 'Karyekar', 'Affiliation': 'Janssen Global Services LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Section of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.'}]",RMD open,['10.1136/rmdopen-2020-001217']
1420,32664244,Effect of PreAnaesThesia Computerized Health (PATCH) Assessment on Duration of Nurse-Patient Consultation and Patient Experience: A Pilot Trial.,"Preanaesthesia health assessment is gradually transitioning from paper-based, face-to-face assessment to digitized assessment, self-administered by the patient. This transition could potentially optimize the various goals of assessment, notably facilitating the efficient collection of the patient's health information. We have previously developed and validated a tablet application (PreAnaesThesia Computerized Health assessment application or ""PATCH"") for patients to conduct preanaesthesia self-assessment. In a randomized controlled trial, we sought to compare the duration of nurse-patient consultation and patient satisfaction between patients who underwent PATCH self-assessment vs. standard care nurse-led assessment. Fifty-two elective surgical patients were randomized to complete either PATCH assessment or standard care nurse-led assessment at an outpatient preoperative clinic. The duration of nurse-patient consultation was subsequently noted for all patients who also completed a satisfaction survey. The mean (SD) nurse-patient consultation times in the PATCH and standard care groups were comparable, at 11.5 (3.6) min and 12.2 (2.9) min, respectively ( p  = 0.703). Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups. Favorable perceptions of PATCH among users ranged between 41.7% and 79.2%. In conclusion, PATCH self-assessment can feasibly be introduced into current practice with comparable nurse-patient consultation times and patient satisfaction.",2020,"Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups.",['Fifty-two elective surgical patients'],"['PATCH self-assessment vs. standard care nurse-led assessment', 'PreAnaesThesia Computerized Health (PATCH) Assessment', 'tablet application (PreAnaesThesia Computerized Health assessment application or ""PATCH', 'PATCH assessment or standard care nurse-led assessment at an outpatient preoperative clinic']","['mean (SD) nurse-patient consultation times', 'duration of nurse-patient consultation', 'Overall satisfaction scores']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028658', 'cui_str': 'Nurse Patient Relations'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.0193419,"Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups.","[{'ForeName': 'Tarig', 'Initials': 'T', 'LastName': 'Osman', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Lew', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lum', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Chew', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Rajive', 'Initials': 'R', 'LastName': 'Dabas', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Ban Leong', 'Initials': 'BL', 'LastName': 'Sng', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17144972']
1421,32664535,Manipulative Therapy Plus Ankle Therapeutic Exercises for Adolescent Baseball Players with Chronic Ankle Instability: A Single-Blinded Randomized Controlled Trial.,"Manipulative therapies and exercises are commonly used for the management of chronic ankle instability (CAI), but there is no evidence regarding the efficacy of high-velocity low-amplitude manipulation (HVLA) in addition to ankle therapeutic exercise to improve CAI in adolescent baseball players (ABP). To compare the effects of HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone on ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability in ABP with CAI, a single-blinded randomized controlled trial was conducted. A total of 31 ABP with CAI were randomly allocated to the intervention (n = 16) or control (n = 15) groups. The intervention group received HVLA plus resistance exercise twice a week for 4 weeks, while the control group received resistance exercise alone. Ankle status, pain intensity, PPT, ROM, and balance ability were assessed before and after the intervention. The American Orthopedic Foot and Ankle Society scores showed significant group and time interactions (total,  p  = 0.002; pain,  p  < 0.001; alignment,  p  = 0.001). There were significant group and time interactions in pain intensity (resting pain,  p  = 0.008; movement pain,  p  < 0.001). For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026). The unipedal stance of the balance ability showed significant group and time interactions in path length ( p  = 0.006) and velocity ( p  = 0.006). Adding HVLA to resistance exercises may be synergistically effective in improving the ankle status, pain intensity, ROM, and balance ability in ABP with CAI.",2020,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","['A total of 31 ABP with CAI', 'Adolescent Baseball Players with Chronic Ankle Instability', 'adolescent baseball players (ABP']","['Manipulative Therapy Plus Ankle Therapeutic Exercises', 'Manipulative therapies and exercises', 'resistance exercise alone', 'HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone', 'HVLA plus resistance exercise']","['ankle status, pain intensity, ROM, and balance ability', 'time interactions in path length', 'Ankle status, pain intensity, PPT, ROM, and balance ability', 'time interactions in pain intensity (resting pain,  p  = 0.008; movement pain', 'time interactions on dorsiflexion', 'ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}]","[{'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}]",31.0,0.0724231,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Suk-Chan', 'Initials': 'SC', 'LastName': 'Hahm', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17144997']
1422,32669306,Effects of Intensive Blood Pressure Control in Patients with and without Albuminuria:  Post Hoc  Analyses from SPRINT.,"BACKGROUND AND OBJECTIVES


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


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


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


Albuminuria did not modify the absolute benefits and risks of intensive systolic BP lowering.",2020,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","['nondiabetic adults ≥50 years of age at high cardiovascular risk to a systolic BP target of <120 or <140 mm Hg, measured by automated office BP', 'Patients with and without Albuminuria', 'participants with albuminuria (intensive, 1.74 per 100 person-years; standard, 1.17 per 100 person-years) than in participants without albuminuria (intensive, 0.48 per 100 person-years; standard, 0.11 per 100 person-years']",['Intensive Blood Pressure Control'],"['eGFR decline, cardiovascular events, or mortality', 'Incidence rates of ≥40% eGFR decline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C4517425', 'cui_str': '0.11'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.459874,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","[{'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Kidney Health Research Institute, Department of Population Health Sciences, Geisinger Health System, Danville, Pennsylvania achang@geisinger.edu.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Kramer', 'Affiliation': 'Division of Nephrology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Morgan E', 'Initials': 'ME', 'LastName': 'Grams', 'Affiliation': 'Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Public Health, University of Massachusetts-Lowell, Lowell, Massachusetts.'}, {'ForeName': 'Udayan', 'Initials': 'U', 'LastName': 'Bhatt', 'Affiliation': 'Division of Nephrology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Renal Division, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drawz', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension and Metabolic Research Institute, Carollton, Texas.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Amret', 'Initials': 'A', 'LastName': 'Hawfield', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horwitz', 'Affiliation': 'Division of Nephrology, MetroHealth Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McLouth', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Morisky', 'Affiliation': 'Department of Community Health Sciences, University of California, Los Angeles Fielding School of Public Health, Los Angeles, California.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'Department of Cardiology, Veterans Affairs Medical Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Wall', 'Affiliation': 'Division of Nephrology, Veterans Affairs Medical Center, Memphis, Tennessee.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Zias', 'Affiliation': 'Stony Brook University School of Medicine, Stony Brook, New York.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.12371019']
1423,32669132,"Correction to: Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],['home- and gym-based resistance exercise training'],"['glycaemic control, body composition and muscle strength']",[],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0448273,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al Ozairi', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dalal', 'Initials': 'D', 'LastName': 'Alsaeed', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Taliping', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Jalali', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'El Samad', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mashankar', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Etab', 'Initials': 'E', 'LastName': 'Taghadom', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Guess', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Gray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK. stuart.gray@glasgow.ac.uk.'}]",Trials,['10.1186/s13063-020-04597-4']
1424,32674691,Omission of a carbohydrate-rich breakfast impairs evening endurance exercise performance despite complete dietary compensation at lunch.,"Omission of a carbohydrate-rich breakfast followed by consuming an  ad libitum  lunch impairs evening exercise performance. However, it is unclear if this is due to breakfast omission  per se , or secondary to lower carbohydrate intake over the day. To test whether impaired evening performance following breakfast omission persists when complete dietary compensation occurs at lunch, in a randomised cross-over design, eleven highly trained cyclists (age: 25 ± 7 y, VO 2 max: 61 ± 5 ml·kg -1 ·min -1 ) completed two trials: breakfast (B) and no breakfast (NB). During B, participants consumed an individualised breakfast (583 ± 54 kcal; 8-9am) and lunch (874 ± 80 kcal; 12-2pm), whilst during NB participants fasted until 12pm and then consumed a standardised lunch (1457 ± 134 kcal: 12-2pm). The overall energy (1457 ± 134 kcal) and macronutrient profile (carbohydrate: 81.5 ± 0.4%, fat: 5.8 ± 0.1%, protein: 12.7 ± 0.3%) was identical in both trials, with timing the only difference. Mean power output during a 20 km time trial performed in the evening was ~3% lower in NB compared to B (mean difference [95% CI]: -9.1 [-15.3, -2.9] watts,  p  < 0.01 for condition main effect). No differences in heart rate, blood glucose or blood lactate concentrations were apparent, but perception of effort appeared to be higher in the early stages of the time trial in NB compared to B despite lower power output. Impaired high-intensity endurance performance in the evening following breakfast omission is related to meal timing rather than carbohydrate intake / availability. Provision of an early morning high-carbohydrate meal should be considered to optimise evening exercise performance.",2020,"No differences in heart rate, blood glucose or blood lactate concentrations were apparent, but perception of effort appeared to be higher in the early stages of the time trial in NB compared to B despite lower power output.","['eleven highly trained cyclists (age: 25 ± 7 y, VO 2 max: 61 ± 5 ml·kg -1 ·min -1 ) completed two trials']","['breakfast (B) and no breakfast (NB', 'carbohydrate-rich breakfast']","['Mean power output', 'heart rate, blood glucose or blood lactate concentrations', 'evening exercise performance', 'Impaired high-intensity endurance performance']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",11.0,0.153908,"No differences in heart rate, blood glucose or blood lactate concentrations were apparent, but perception of effort appeared to be higher in the early stages of the time trial in NB compared to B despite lower power output.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Metcalfe', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre, Swansea University, Wales, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre, Swansea University, Wales, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lamb', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre, Swansea University, Wales, UK.'}, {'ForeName': 'Enhad A', 'Initials': 'EA', 'LastName': 'Chowdhury', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1797890']
1425,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1426,32675772,Durable Suppression and Low Rate of Virologic Failure 3 Years After Switch to Dolutegravir + Rilpivirine 2-Drug Regimen: 148-Week Results From the SWORD-1 and -2 Randomized Clinical Trials.,"BACKGROUND


The SWORD trials showed that in participants who achieved virologic suppression taking 3- or 4-drug regimens, switching to the 2-drug regimen dolutegravir plus rilpivirine was non-inferior in maintaining HIV-1 RNA <50 copies/mL at the Week 48 primary endpoint. We present pooled Week 148 analysis results from both studies.
SETTING


SWORD-1: 65 centers, 13 countries; SWORD-2: 60 centers, 11 countries.
METHODS


SWORD-1 and SWORD-2 are identical, open-label, phase III studies. Participants with screening HIV-1 RNA <50 copies/mL for ≥6 months; no prior virologic failure; and no documented resistance-associated major PI, INI, NRTI, or NNRTI mutations or integrase resistance-associated substitution R263K were randomly assigned 1:1 to switch to once-daily dolutegravir 50 mg plus rilpivirine 25 mg on Day 1 (Early-Switch group) or to continue their current antiretroviral regimen and, if virologically suppressed at Week 48, switch to dolutegravir plus rilpivirine at Week 52 (Late-Switch group) until Week 148.
RESULTS


Using Snapshot algorithm at Week 148, 432/513 (84%) Early-Switch participants (148 weeks of exposure) and 428/477 (90%) Late-Switch participants (96 weeks of exposure) maintained HIV-1 RNA <50 copies/mL. Eleven participants (1%) on dolutegravir plus rilpivirine met the confirmed virologic withdrawal criterion through Week 148 (Early-Switch group, n=8; Late-Switch group, n=3) with no integrase resistance identified. NNRTI resistance-associated mutations were identified in 6 participants (<1%). Drug-related adverse events (grades 2-4) were observed in 31 (6%) Early-Switch and 16 (3%) Late-Switch participants. Significant improvements in bone biomarkers were observed. Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.",2020,"Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.","['65 centers, 13 countries; SWORD-2', 'SWORD-1', 'R263K', 'Early-Switch participants (148 weeks of exposure) and 428/477 (90', '60 centers, 11 countries']","['Dolutegravir + Rilpivirine', 'rilpivirine', 'tenofovir disoproxil fumarate', 'dolutegravir 50 mg plus rilpivirine', 'dolutegravir plus rilpivirine']","['virologic failure', 'renal biomarkers', 'Durable Suppression and Low Rate of Virologic Failure', 'virologic suppression', 'bone biomarkers', 'resistance-associated major PI, INI, NRTI, or NNRTI mutations or integrase resistance-associated substitution', 'NNRTI resistance-associated mutations']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0522656', 'cui_str': 'Sword'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C4530989', 'cui_str': 'dolutegravir and rilpivirine'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0063690', 'cui_str': 'Integrase'}]",,0.0523723,"Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'van Wyk', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rubio', 'Affiliation': 'HIV Unit, Department of Internal Medicine, Hospital Universitario 12 de Octubre, UCM, Madrid, Spain.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Munich University Hospital, Med IV, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'East Sydney Doctors, Darlinghurst, Sydney, Australia.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Khuong-Josses', 'Affiliation': 'CHG - Hôpital Delafontaine, Saint Denis Cedex, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parks', 'Affiliation': 'Central West Clinical Research, St Louis, MO, USA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Angelis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Lesley P', 'Initials': 'LP', 'LastName': 'Kahl', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Ruolan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Maria Claudia', 'Initials': 'MC', 'LastName': 'Nascimento', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Vandermeulen', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002449']
1427,32673652,Can the Positional Release Technique Affect Central Sensitization in Patients With Chronic Tension-Type Headache? A Randomized Clinical Trial.,"OBJECTIVES


To investigate whether the positional release technique (PRT) affects central sensitization in patients with chronic tension-type headache (TTH).
DESIGN


Randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis.
SETTING


Two university neurology clinics.
PARTICIPANTS


Patients (N=32) with TTH and myofascial trigger points (MTrP) in their cervical muscles.
INTERVENTIONS


Patients in the PRT group received 10 treatment sessions for each of their MTrPs over the course of 5 weeks. All participants could use ibuprofen 200 mg for their headaches during the study.
MAIN OUTCOME MEASURES


The primary outcome measure was brain metabolite profile. The secondary outcome measures were headache frequency and intensity, McGill score, and pressure pain threshold (PPT), which were evaluated in each participant during 5 weeks with proton magnetic resonance spectroscopy, patients' self-reports, the McGill Pain Questionnaire, and a pressure algometer.
RESULTS


Analysis of the data from 26 patients showed that headache frequency (P=.001), headache intensity (P=.002), McGill score (P=.003), and local PPT (P=.003) changed significantly after PRT. The myo-inositol/creatine concentration ratio in the somatosensory cortex (P=.041) decreased significantly in the control group. Furthermore, there were significant differences between groups in headache frequency (P<.001), headache intensity (P<.001), McGill score (P<.001), local PPT (P=.004), distal PPT (P=.041), and glutamate-glutamine/creatine concentration ratio in the thalamus (P=.014).
CONCLUSIONS


These findings indicate that PRT did not affect central sensitization in patients with TTH despite the improvement in clinical symptoms.",2020,Myo-inositol/creatine concentration ratio in the somatosensory cortex (p=0.041) decreased significantly in the control group.,"['patients with chronic TTH', 'patients with TTH', '32 patients with TTH and MTrPs in their cervical muscles', 'patients with chronic tension-type headache', 'Two university neurology clinics']","['positional release technique (PRT', 'ibuprofen']","['McGill Pain Questionnaire and a pressure algometer', 'headache frequency', 'distal PPT', 'brain metabolite profile', 'McGill score', 'local PPT', 'headache frequency and intensity, McGill score, and pressure pain threshold', 'headache intensity', 'Myo-inositol/creatine concentration ratio', 'headache intensity (p<0.001), McGill score (p<0.001), local PPT', 'glutamate-glutamine/creatine concentration ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0393738', 'cui_str': 'Chronic tension-type headache'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]",32.0,0.145641,Myo-inositol/creatine concentration ratio in the somatosensory cortex (p=0.041) decreased significantly in the control group.,"[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mohamadi', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rojhani-Shirazi', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: rojhaniz@sums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Assadsangabi', 'Affiliation': 'Department of Radiology, Davis School of Medicine, University of California, Sacramento, CA.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Rahimi-Jaberi', 'Affiliation': 'Department of Neurology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.028']
1428,32673830,Accelerated treatment of endocarditis-The POET II trial: Rationale and design of a randomized controlled trial.,"BACKGROUND


The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients.
OBJECTIVE


The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE.
METHODS


The POET II trial is a multicenter, multinational, open-label, noninferiority randomized controlled trial. Patients with definite left-sided IE due to Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis will be eligible for enrolment. Each patient will be randomized to accelerated antibiotic treatment or standard-length treatment (1:1) following clinical stabilization as defined by clinical parameters, laboratory values, and transesophageal echocardiography findings. Accelerated treatment will be between 2 and 4 weeks, whereas standard-length treatment will be between 4 and 6 weeks, depending on microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis. The primary outcome is a composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6 months of randomization.
CONCLUSIONS


The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis. The results of the POET II trial will improve the evidence base of treatment recommendations, and clinical practice may be altered.",2020,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","['patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis', 'patients with left-sided IE']","['accelerated (shortened) antibiotic therapy', 'accelerated antibiotic therapy']","['microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis', 'composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6\u202fmonths of randomization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1827151', 'cui_str': 'Left sided infective endocarditis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1142550', 'cui_str': 'Native valve endocarditis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.224308,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","[{'ForeName': 'Lauge', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mia Marie', 'Initials': 'MM', 'LastName': 'Pries-Heje', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus Bo', 'Initials': 'RB', 'LastName': 'Hasselbalch', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Åkesson', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horvath', 'Affiliation': 'Department of Infectious Diseases, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Povlsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Müllertz', 'Affiliation': 'Department of Cardiology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Christian Ditlev', 'Initials': 'CD', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Ihlemann', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jannik', 'Initials': 'J', 'LastName': 'Helweg-Larsen', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Microbiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emil Loldrup', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark. Electronic address: Henning.Bundgaard@regionh.dk.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.05.012']
1429,32664369,Countering Vaccine Hesitancy among Pregnant Women in England: The Case of Boostrix-IPV.,"This study explored the effects of message framing on vaccine hesitancy for the antenatal whooping cough vaccine. The study also assessed whether the Theory of Planned Behaviour (TPB) constructs had any explanatory utility for vaccine intentions and behaviours in pregnant women. A between-subjects, cross-sectional design was employed. Participants ( n  = 282) were women who were pregnant (mean = 28 weeks, SD = 7.0), living in England and between 18 and 44 years of age. A self-report web-based survey was used to collect data. Participants were randomly assigned to read either (i) disease risk, (ii) myth busting, or (iii) control information before answering questions based on the TPB. No significant effects of message framing were found. Attitudes (Beta = 0.699;  p  < 0.001) and subjective norms (Beta = 0.262,  p  < 0.001) significantly predicted intention to vaccinate but perceived behavioural control did not. The TPB constructs accounted for 86% and 36% of the variance in vaccine intention and vaccine history respectively. Disease risk information did not influence vaccine acceptability in this sample of English pregnant women. The study offered preliminary evidence that interventions targeting constructs from the TPB may promote vaccine acceptability among pregnant women.",2020,No significant effects of message framing were found.,"['Participants ( n  = 282) were women who were pregnant (mean = 28 weeks, SD = 7.0), living in England and between 18 and 44 years of age', 'Pregnant Women in England', 'English pregnant women', 'pregnant women']","['read either (i) disease risk, (ii) myth busting, or (iii) control information before answering questions based on the TPB']","['behavioural control', 'vaccine acceptability', 'Attitudes']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",282.0,0.10224,No significant effects of message framing were found.,"[{'ForeName': 'Mairead', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Laura A V', 'Initials': 'LAV', 'LastName': 'Marlow', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17144984']
1430,32664375,Long-Term Influence of the Practice of Physical Activity on the Self-Perceived Quality of Life of Women with Breast Cancer: A Randomized Controlled Trial.,"Background:  There is still no consensus on the most suitable interventions for exercise practice in breast cancer survivors. Therefore, the aim of this study was to evaluate the effect of a two-year physical activity intervention (strength, aqua fitness and aerobic exercise programs) on the self-perceived quality of life and physical functionality of female breast cancer survivors.  Methods:  A randomized, controlled, experimental trial with a sample of 316 women (63 ± 7 years), who had been diagnosed with breast cancer. The evaluations were performed using the Rikli & Jones Senior Fitness Test, and the Short Form 12 Health Survey (SF-12).  Results:  The participants in the strength program showed statistically significant improvements in all the items of the SF-12. The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12. The participants in the aerobic program showed a progressive deterioration of Vitality and Mental Health.  Conclusion:  When assigning breast cancer survivors to an exercise program, the preferential or predominant activity should include strength exercises. On the other hand, as the second choice, those patients with particularly low levels of Vitality or Physical Limitations will show greater improvement with an aqua fitness program.",2020,"The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12.","['breast cancer survivors', 'Women with Breast Cancer', 'female breast cancer survivors', '316 women (63 ± 7 years), who had been diagnosed with breast cancer']","['two-year physical activity intervention (strength, aqua fitness and aerobic exercise programs']","['Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12', 'self-perceived quality of life and physical functionality', 'progressive deterioration of Vitality and Mental Health', 'Self-Perceived Quality of Life', 'SF-12']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",316.0,0.0362931,"The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12.","[{'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'García-Soidán', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Pérez-Ribao', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Leirós-Rodríguez', 'Affiliation': 'Faculty of Physical Therapy, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Anxela', 'Initials': 'A', 'LastName': 'Soto-Rodríguez', 'Affiliation': 'Health Service from Galicia (SERGAS), Galician Health Services-Ourense Hospital, 32005 Ourense, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17144986']
1431,32668323,A randomized controlled trial of lung ultrasound-guided therapy in heart failure (CLUSTER-HF study).,"BACKGROUND


Lung ultrasound (LUS) has emerged as a new tool for the evaluation of congestion in heart failure (HF); incorporation of LUS during follow-up may detect congestion earlier and prompt interventions to prevent hospitalizations. The aim of this study was to test the hypothesis that the incorporation of LUS during follow-up of patients with HF may reduce the rate of adverse events compared with usual care.
METHODS


In this single-blinded, randomized controlled trial, patients were randomized into an LUS-guided arm or control arm. Patients were followed in 4 prespecified visits during a 6-month period. LUS was performed in every patient visit in both groups; however, LUS results were available for the treating physician only in the LUS group. The primary outcome was the composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause.
RESULTS


One hundred twenty-six patients were randomized to either LUS (n = 63) or control (n = 63) (age 62.5 ± 10 years, median left ventricular ejection fraction 31%). The primary end point occurred in 30 (47.6%) patients in the control group and 20 (31.7%) patients in the LUS group (P = .041). LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001). No significant differences in rehospitalizations for HF or death were found.
CONCLUSIONS


Incorporation of LUS into clinical follow-up of patients with HF significantly reduced the risk of urgent visits for worsening HF.",2020,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).",['One hundred twenty-six patients'],"['LUS-guided arm or control arm', 'lung ultrasound-guided therapy', 'Lung ultrasound (LUS', 'LUS']","['rate of adverse events', 'urgent HF visits', 'rehospitalizations for HF or death', 'composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause', 'risk of urgent visits']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",126.0,0.114217,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Araiza-Garaygordobil', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico. Electronic address: dargaray@gmail.com.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gopar-Nieto', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Amezcua', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Cabello-López', 'Affiliation': 'Centro Médico Nacional ""Siglo XXI,"" Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Alanis-Estrada', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Luna-Herbert', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'González-Pacheco', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Cynthia Paola', 'Initials': 'CP', 'LastName': 'Paredes-Paucar', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Martinez Daniel', 'Initials': 'MD', 'LastName': 'Sierra-Lara', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Briseño-De la Cruz', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Rodriguez-Zanella', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Martinez-Rios', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Arias-Mendoza', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}]",American heart journal,['10.1016/j.ahj.2020.06.003']
1432,32676976,Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.,"OBJECTIVES


To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
METHODS


A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
RESULTS


An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
CONCLUSIONS


Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).",2020,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","['48 participants (24 cases each arm', 'COVID-19 patients']","['control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir', 'Keguan-1-based integrative therapy']","['adverse events', 'development of ARDS', 'adverse events, time to fever resolution, ARDS development, and lung injury', 'time to fever resolution']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}]",48.0,0.271286,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","[{'ForeName': 'Jia-Bo', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhong-Xia', 'Initials': 'ZX', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Hui', 'Initials': 'JH', 'LastName': 'Dong', 'Affiliation': 'Department of Radiology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Feng', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Niu', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Tian-Jun', 'Initials': 'TJ', 'LastName': 'Jiang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Feng', 'Initials': 'JF', 'LastName': 'Bi', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhao-Fang', 'Initials': 'ZF', 'LastName': 'Bai', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Guo', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Si-Miao', 'Initials': 'SM', 'LastName': 'Yu', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Qiang', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zi-Teng', 'Initials': 'ZT', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Zhan', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Yan', 'Initials': 'PY', 'LastName': 'Li', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jin-Biao', 'Initials': 'JB', 'LastName': 'Ding', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Zhao', 'Affiliation': 'College of Life Science, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Xue-Ai', 'Initials': 'XA', 'LastName': 'Song', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jian-Yuan', 'Initials': 'JY', 'LastName': 'Tang', 'Affiliation': 'Sichuan Evidence-Based Medicine Center of Traditional Chinese Medicine Affliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Dong-Chu', 'Initials': 'DC', 'LastName': 'He', 'Affiliation': 'Department of Integrated Treatment, General Hospital of Central Theater Command, Wuhan, 430070, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Clinical Research Center for Infectious Diseases, Beijing, 100039, China.'}, {'ForeName': 'En-Qiang', 'Initials': 'EQ', 'LastName': 'Qin', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. qeq2004@sina.com.'}, {'ForeName': 'Rui-Lin', 'Initials': 'RL', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. wrl7905@163.com.'}, {'ForeName': 'Xiao-He', 'Initials': 'XH', 'LastName': 'Xiao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. pharmacy302xxh@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3426-7']
1433,32679201,Predicting Nasal High-Flow Treatment Success in Newborn Infants with Respiratory Distress Cared for in Nontertiary Hospitals.,"OBJECTIVE


To evaluate demographic and clinical variables as predictors of nasal high-flow treatment success in newborn infants with respiratory distress cared for in Australian nontertiary special care nurseries.
STUDY DESIGN


A secondary analysis of the HUNTER trial, a multicenter, randomized controlled trial evaluating nasal high-flow as primary respiratory support for newborn infants with respiratory distress who were born ≥31 weeks of gestation and with birth weight ≥1200 g, and cared for in Australian nontertiary special care nurseries. Treatment success within 72 hours after randomization to nasal high-flow was determined using objective criteria. Univariable screening and multivariable analysis was used to determine predictors of nasal high-flow treatment success.
RESULTS


Infants (n = 363) randomized to nasal high-flow in HUNTER were included in the analysis; the mean gestational age was 36.9 ± 2.7 weeks and birth weight 2928 ± 782 g. Of these infants, 290 (80%) experienced nasal high-flow treatment success. On multivariable analysis, nasal high-flow treatment success was predicted by higher gestational age and lower fraction of inspired oxygen immediately before randomization, but not strongly. The final model was found to have an area under the curve of 0.65, which after adjustment for optimism was found to be 0.63 (95% CI, 0.57-0.70).
CONCLUSIONS


Gestational age and supplemental oxygen requirement may be used to guide decisions regarding the most appropriate initial respiratory support for newborn infants in nontertiary special care nurseries. Further prospective research is required to better identify which infants are most likely to be successfully treated with nasal high-flow.
TRIAL REGISTRATION


ACTRN12614001203640.",2020,"The final model was found to have an area under the curve of 0.65, which after adjustment for optimism was found to be 0.63 (95% confidence interval: 0.57-0.70).
","['Newborn Infants with Respiratory Distress Cared for in Non-Tertiary Hospitals', 'in HUNTER were included in the analysis', 'newborn infants in non-tertiary SCNs', 'Infants (n =363) randomized to', 'gestational age was 36.9 (2.7) weeks and birth weight 2928 (782) grams', 'newborn infants with respiratory distress cared for in Australian non-tertiary special care nurseries (SCNs', ""newborn infants, born ≥31 weeks' gestation and had a birth weight ≥1200g, with respiratory distress, cared for in Australian non-tertiary SCNs, was performed""]",['nHF'],"['Nasal High-Flow Treatment Success', 'nHF treatment success', 'mean (standard deviation']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",[],"[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",363.0,0.209507,"The final model was found to have an area under the curve of 0.65, which after adjustment for optimism was found to be 0.63 (95% confidence interval: 0.57-0.70).
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McKimmie-Doherty', 'Affiliation': ""Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Australia; Newborn Research Center, The Royal Women's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gaston R B', 'Initials': 'GRB', 'LastName': 'Arnolda', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, New South Wales, Australia; University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Buckmaster', 'Affiliation': 'Pediatrics, Central Coast Local Health District, Gosford, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Center, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Hodgson', 'Affiliation': ""Newborn Research Center, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Pediatric Infant Perinatal Emergency Retrieval, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ian M R', 'Initials': 'IMR', 'LastName': 'Wright', 'Affiliation': 'Illawarra Health and Medical Research Institute, and Graduate Medicine, University of Wollongong, Wollongong, New South Wales, Australia; Illawarra and Shoalhaven Health District, Wollongong, New South Wales, Australia; The University of Queensland Center for Clinical Research, The University of Queensland, Brisbane, Queensland, Australia; James Cook University, Douglas, Queensland, Australia.'}, {'ForeName': 'Calum T', 'Initials': 'CT', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, Australia; Department of Pediatrics, Monash University, Melbourne, Australia.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Center, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Center, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia. Electronic address: Brett.Manley@thewomens.org.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.07.037']
1434,32679866,The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients with Burn: A Prospective Randomized Single-Blind Study.,"We performed pulmonary function (PF) tests and factors affecting PF evaluation in 120 patients with inhalation injury to evaluate the effects of pulmonary rehabilitation (PR) in burn patients with inhalation injury. Patients were randomized into pulmonary rehabilitation (PR) group and conventional rehabilitation (CON) group. PF tests, including forced vital capacity (FVC), 1-s forced expiratory volume FEV1), maximum voluntary ventilation (MVV), and respiratory muscles strength (maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP)), were measured by mouth pressure meter in the sitting position. Diffusing capacity for carbon monoxide (DLco) was determined by the single-breath carbon monoxide technique. Peak cough flow (PCF) was measured by a peak flow meter. Diaphragmatic mobility (DM) was evaluated on anteroposterior fluoroscopy. All evaluations were performed in all groups at baseline and after 12 weeks. There were no differences in evaluations between the PR group and CON group before the intervention. There were significant improvements in the PCF and MIP (%) changes, taken before and after rehabilitation in the PR group, compared with the changes in the CON group ( p  = 0.01, and  p  = 0.04). There were no significant changes in the other parameters in the PR group compared with the changes in the CON group ( p  > 0.05). There were significant differences in DLco (%), MIP, MIP (%), and DM between the PR group and the CON group ( p  = 0.02,  p  = 0.005, and  p  = 0.001) after 12 weeks of rehabilitation. There were no differences between the PR group and CON group after 12 weeks rehabilitation in the other parameters ( p  > 0.05). PR for patients with major burns and smoke inhalation induced improved PCF, MIP, MIP (%), DLco (%), and DM. These results show that PR should be a fundamental component of the treatment program for patients with burns.",2020,There were no differences between the PR group and CON group after 12 weeks rehabilitation in the other parameters ( p  > 0.05).,"['patients with major burns and smoke inhalation', '120 patients with inhalation injury', 'Patients with Burn', 'burn patients with inhalation injury', 'patients with burns']","['pulmonary rehabilitation (PR) group and conventional rehabilitation (CON', 'CON', 'pulmonary rehabilitation (PR', 'Pulmonary Rehabilitation']","['forced vital capacity (FVC', 'Lung Function and Exercise Capacity', 'Diaphragmatic mobility (DM', 'PCF, MIP, MIP (%), DLco (%), and DM', 'PCF and MIP', 'mouth pressure meter in the sitting position', '1-s forced expiratory volume FEV1), maximum voluntary ventilation (MVV), and respiratory muscles strength (maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP', 'Peak cough flow (PCF', 'DLco (%), MIP, MIP (%), and DM', 'Diffusing capacity for carbon monoxide (DLco']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0037367', 'cui_str': 'Smoke inhalation injury'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0745334', 'cui_str': 'Inhalation injury'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280474', 'cui_str': 'Transfer factor (respiratory measure)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",120.0,0.0139461,There were no differences between the PR group and CON group after 12 weeks rehabilitation in the other parameters ( p  > 0.05).,"[{'ForeName': 'Yu Hui', 'Initials': 'YH', 'LastName': 'Won', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju 54907 Korea.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, 94-200 Yeongdeungpo-Dong Yeongdeungpo-Ku, Seoul 07247, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, 94-200 Yeongdeungpo-Dong Yeongdeungpo-Ku, Seoul 07247, Korea.'}, {'ForeName': 'Cheong Hoon', 'Initials': 'CH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, 94-200 Yeongdeungpo-Dong Yeongdeungpo-Ku, Seoul 07247, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9072250']
1435,32680841,A Swedish primary healthcare prevention programme focusing on promotion of physical activity and a healthy lifestyle reduced cardiovascular events and mortality: 22-year follow-up of 5761 study participants and a reference group.,"OBJECTIVE


To evaluate long-term risk of first cardiovascular (CV) events, CV deaths and all-cause deaths in community-dwelling participants of a cardiovascular disease (CVD) prevention programme delivered in a primary care setting.
METHODS


Individuals who visited a primary healthcare service in Sollentuna (Sweden) and agreed to participate in the programme between 1988 and 1993 were followed. They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management. Participants (n=5761) were compared with a randomly selected, propensity score-matched reference group from the general population in Stockholm County (n=34 556). All individuals were followed in Swedish registers until December 2011.
RESULTS


In the intervention group and the reference group there were 698 (12.1%) and 4647 (13.4%) first CV events, 308 (5.3%) and 2261 (6.5%) CV deaths, and 919 (16.5%) and 6405 (18.5%) all-cause deaths, respectively, during a mean follow-up of 22 years. The HR (95% CI) in the intervention group compared with the reference group was 0.88 (0.81 to 0.95) for first CV events, 0.79 (0.70 to 0.89) for CV deaths and 0.83 (0.78 to 0.89) for all-cause deaths.
CONCLUSIONS


Participation in a CVD prevention programme in primary healthcare focusing on promotion of physical activity and healthy lifestyle was associated with lower risk of CV events (12%), CV deaths (21%) and all-cause deaths (17%) after two decades. Promoting physical activity and healthy living in the primary healthcare setting may prevent CVD.",2020,"They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management.","['Participants (n=5761) were compared with a randomly selected, propensity score-matched reference group from the general population in Stockholm County (n=34 556', 'All individuals were followed in Swedish registers until December 2011', 'community-dwelling participants of a cardiovascular disease (CVD) prevention programme delivered in a primary care setting', 'Individuals who visited a primary healthcare service in Sollentuna (Sweden) and agreed to participate in the programme between 1988 and 1993 were followed', '5761 study participants and a reference group']",[],"['risk of CV events', 'cardiovascular events and mortality', 'CV deaths']","[{'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",5761.0,0.0433087,"They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management.","[{'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Journath', 'Affiliation': 'Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden gunilla.journath@ki.se.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Hammar', 'Affiliation': 'Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Vikström', 'Affiliation': 'Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Linnersjö', 'Affiliation': 'Unit of Occupational Medicine, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Walldius', 'Affiliation': 'Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Krakau', 'Affiliation': 'Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lindgren', 'Affiliation': 'Medical Management Center, Department of Learning, Information, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'de Faire', 'Affiliation': 'Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellenius', 'Affiliation': 'Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101749']
1436,31822477,Implementing a junior high school-based programme to reduce sports injuries through neuromuscular training (iSPRINT): a cluster randomised controlled trial (RCT).,"OBJECTIVE


To evaluate the effectiveness of a junior high school-based sports injury prevention programme to reduce injuries through neuromuscular training (NMT).
METHODS


This was a cluster randomised controlled trial. Students were recruited from 12 Calgary junior high schools (2014-2017). iSPRINT is a 15 min NMT warm-up including aerobic, agility, strength and balance exercises. Following a workshop, teachers delivered a 12-week iSPRINT NMT (six schools) or a standard-of-practice warm-up (six schools) in physical education classes. The definition of all recorded injuries included injuries that resulted in participants being unable to complete a sport and recreation (S&R) session, lost time from sport and/or seek medical attention. Incidence rate ratios (IRRs) were estimated based on multiple multilevel Poisson regression analyses (adjusting for sex (considering effect modification) and previous injury, offset by S&R participation hours, and school-level and class-level random effects were examined) for intent-to-treat analyses.
RESULTS


1067 students (aged 11-16) were recruited across 12 schools (6 intervention schools (22 classes), 6 control schools (27 classes); 53.7% female, 46.3% male). The iSPRINT programme was protective of all recorded S&R injuries for girls (IRR=0.543, 95% CI 0.295 to 0.998), but not for boys (IRR=0.866, 95% CI 0.425 to 1.766). The iSPRINT programme was also protective of each of lower extremity injuries (IRR=0.357, 95% CI 0.159 to 0.799) and medical attention injuries (IRR=0.289, 95% CI 0.135 to 0.619) for girls, but not for boys (IRR=1.055, 95% CI 0.404 to 2.753 and IRR=0.639, 95% CI 0.266 to 1.532, respectively).
CONCLUSION


The iSPRINT NMT warm-up was effective in preventing each of all recorded injuries, lower extremity injuries and medically treated S&R injuries in female junior high school students.
TRIAL REGISTRATION NUMBER


NCT03312504.",2020,"The iSPRINT programme was protective of all recorded S&R injuries for girls (IRR=0.543, 95% CI 0.295 to 0.998), but not for boys (IRR=0.866, 95% CI 0.425 to 1.766).","['1067 students (aged 11-16) were recruited across 12 schools (6 intervention schools (22 classes), 6 control schools (27 classes); 53.7% female, 46.3% male', 'Students were recruited from 12 Calgary junior high schools (2014-2017', 'female junior high school students']","['neuromuscular training (iSPRINT', '12-week iSPRINT NMT (six schools) or a standard-of-practice warm-up (six schools) in physical education classes', 'junior high school-based sports injury prevention programme']","['medical attention injuries', 'extremity injuries', 'Incidence rate ratios (IRRs']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004161', 'cui_str': 'Sports injury'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0743668', 'cui_str': 'Limb injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.058628,"The iSPRINT programme was protective of all recorded S&R injuries for girls (IRR=0.543, 95% CI 0.295 to 0.998), but not for boys (IRR=0.866, 95% CI 0.425 to 1.766).","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Emery', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada caemery@ucalgary.ca.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'van den Berg', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sarah Ann', 'Initials': 'SA', 'LastName': 'Richmond', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Palacios-Derflingher', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Carly D', 'Initials': 'CD', 'LastName': 'McKay', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Doyle-Baker', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McKinlay', 'Affiliation': 'Ever Active Schools, Calgary, Alberta, Canada.'}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Toomey', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Departments of Pediatrics and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Collaboration for Health and Safety in Sports, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Belton', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Macpherson', 'Affiliation': 'Faculty of Health, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Brent E', 'Initials': 'BE', 'LastName': 'Hagel', 'Affiliation': 'Departments of Pediatrics and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101117']
1437,32681995,Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study.,"STUDY OBJECTIVE


To compare a reusable hysteroscopic morcellator and standard resectoscopes in the hysteroscopic management of uterine polyps.
DESIGN


Single-center randomized prospective single-blind trial (resectoscope-morcellator study).
SETTING


Centre Médico-chirurgical Obstétrique teaching hospital, Strasbourg University Hospitals, France.
PATIENTS


All patients presenting with a single endometrial polyp of size 1 cm or larger.
INTERVENTIONS


After consent, the patients were randomized into 2 groups: hysteroscopic morcellation (HM) group or standard resection (SR) group. Office-based review hysteroscopy was performed 6 weeks to 8 weeks after surgery. Primary end point: time of morcellation or resection.
SECONDARY OUTCOMES


total operating time (minutes), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (visual analog scale: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (visual analog scale), and length of hospitalization. At review hysteroscopy, we noted whether the resection or morcellation had been effective and if synechiae were present or absent. Statistical analyses followed Bayesian methods.
MEASUREMENTS AND MAIN RESULTS


Ninety patients were randomized: 45 in the HM group and 45 in the SR group. The average size of polyps at hysteroscopy was 13.3 mm. Morcellation time was lower than resection time (6.1 minutes vs 9 minutes; p [HM < SR] = .996). This also applied to total operating time (12.7 minutes vs 15.6 minutes; p [HM < SR] = .985), number of device insertions (1.50 vs 6; p [HM < SR] > .999), volume of fluid used (766.9 mL vs 1118.9 mL; p [HM < SR] = .994), and fluid deficit (60.2 mL vs 169.8 mL; p [HM < SR] = .989). Operator comfort was better in the HM group (8.4 vs 7.4; p [HM > SR] = .999) as was visualization (4 vs 3.7; p [HM > SR] = .911, highly probable). Operative complications were higher in the SR group (5 vs 0; p [HM < SR] = .989]. One patient in the SR group died after surgery owing to an anesthetic complication (anaphylactic shock complicated by pulmonary embolism). No differences were noted between the groups for pain assessment, length of hospitalization, and outcome on review hysteroscopy.
CONCLUSION


The reusable morcellator is quicker, uses less fluid with less deficit and fewer introductory maneuvers, and offers better comfort and visualization than the resectoscope while being as effective for the hysteroscopic treatment of uterine polyps.",2020,Operative complications were higher in the SR group [5 vs 0; P(HM<SR)=0.989].,"['Ninety patients were randomized, 45 in the HM group and 45 in the SR group', 'All patients presenting a single endometrial polyp of size greater than or equal to a centimeter', 'CMCO teaching hospital, Strasbourg University Hospitals', 'uterine polyps']","['hysteroscopic morcellator (HM) or standard resection group (SR', 'reusable hysteroscopic morcellator and standard resectoscopes', 'reusable morcellator to a resectoscope']","['volume of fluid', 'time of morcellation or resection', 'Morcellation time', 'Operative complications', 'Operator comfort', 'pain assessment, length of hospitalization and outcome on review hysteroscopy', 'number of device insertions', 'average size of polyps at hysteroscopy', 'fluid deficit', 'total operating time (min), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (Visual Analogic Scale VAS: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (VAS), and length of hospitalization', 'total operating time']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0156369', 'cui_str': 'Polyp of corpus uteri'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",90.0,0.0507971,Operative complications were higher in the SR group [5 vs 0; P(HM<SR)=0.989].,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Stoll', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France. Electronic address: francois.stoll@gmail.com.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Lecointre', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Faller', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Host', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hummel', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boisrame', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Cherif', 'Initials': 'C', 'LastName': 'Akladios', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Garbin', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Stoll, Lecointre, Faller, Host, Hummel, Boisrame, Akladios, and Garbin); Medical Information Department (Dr. Meyer), Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.07.007']
1438,32499466,The efficacy of two doses versus 7 days' course of prophylactic antibiotics following cesarean section: An experience from Aminu Kano Teaching Hospital.,"Background


Postcesarean wound infection is a leading cause of prolonged hospital stay. Considerable debates still exist regarding choice of antibiotics, dose, and duration of use.
Objectives


The objective is to compare the efficacy of 2 doses of amoxicillin-clavulanic acid versus a 7 days combination of amoxicillin-clavulanic acid and metronidazole as prophylactic antibiotics following cesarean section (CS).
Methodology


It was a randomized controlled trial that was conducted among 160 women undergoing CS at Aminu Kano Teaching Hospital. Women were randomized into two groups. Group I (study group) received 2 doses of 1.2 g amoxicillin-clavulanic acid. Group II (control group) received a 7 days course of amoxicillin-clavulanic acid and metronidazole. The data obtained were analyzed using SPSS version 17. Categorical (qualitative) variables were analyzed using Chi-square test and Fisher's exact test as appropriate while continuous (quantitative) variables were analyzed using independent sample t-test. P < 0.05 was considered statistically significant.
Results


There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups. There was statistically significant difference in the mean cost of antibiotics (₦2883/US$9.5 vs. ₦7040/US$23.1, P < 0.001) and maternal side effects (10.3% vs. 26.3%, P < 0.001) between the study and the control groups, respectively.
Conclusion


This study found no statistically significant difference in infectious morbidity, duration of hospital stay, and neonatal outcomes when two doses of amoxicillin-clavulanic acid was compared with a 7 days course of prophylactic antibiotic following CS. The use of two doses of amoxicillin-clavulanic acid has the advantages of reduced cost and some maternal side effects. The two doses were cheaper with minimal side effects.",2020,"There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups.","['160 women undergoing CS at Aminu Kano Teaching Hospital', 'cesarean section']","['prophylactic antibiotics', 'amoxicillin-clavulanic acid', 'amoxicillin-clavulanic acid and metronidazole']","['mean duration of hospital stay', 'occurrence of fever', 'mean cost of antibiotics', 'wound infection', 'infectious morbidity, duration of hospital stay, and neonatal outcomes', 'endometritis', 'maternal side effects', 'neonatal outcomes']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",160.0,0.0917406,"There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups.","[{'ForeName': 'Salihu Ozegya', 'Initials': 'SO', 'LastName': 'Mohammed', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Samaila Danjuma', 'Initials': 'SD', 'LastName': 'A Shuaibu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Sule Abdullahi', 'Initials': 'SA', 'LastName': 'Gaya', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Ayyuba', 'Initials': 'A', 'LastName': 'Rabiu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}]",Annals of African medicine,['10.4103/aam.aam_39_19']
1439,32499471,The effect of combination of warm intravenous fluid infusion and forced air warming versus forced air warming alone on maternal temperature and shivering during cesarian delivery under spinal anesthesia.,"Objective


Administration of warm intravenous (IV) fluid infusion and use of forced air warmers is the most easy and physiologically viable method for maintaining normothermia during surgery and postsurgical periods This study was conducted to assess the effect of combination of active warming (AW) methods namely warm IV fluid infusion and forced air warming versus forced air warming only (WA) on maternal temperature during elective C-delivery under spinal anesthesia.
Materials and Methods


A total of 100 patients scheduled for elective c-section were grouped into those who received both warmed IV fluid infusion and forced air warmer (Combination of active warming WI= 50) and those who received only forced air warmer (WA = 50). Core body temperature and shivering incidence were recorded using a tympanic thermometer from prespinal till the end of surgery every 10 min and in postanesthesia care unit (PACU) at 0, 15, and 30 min.
Results


Core temperature showed statistically significant difference in 15, 35, 45, and 55 min between air warmer and warm infusion groups and in PACU at 0, 15, and 30 min, it was statistically significant (P = 0.000) among WI group (mean temperature = 36.79°C) when compared to WA group (mean temperature = 35.96°C). There was a lower incidence of shivering in WI compared to WA group, which is statistically significant.
Conclusion


Combination of warm Intravenous fluid infusion and Forced air warming is better than forced air warming alone. In maintaining near normal maternal core body temperature during elective cesarean section following spinal anesthesia. Combined warming method also reduces shivering incidence.",2020,"There was a lower incidence of shivering in WI compared to WA group, which is statistically significant.
","['maternal temperature and shivering during cesarian delivery under spinal anesthesia', '100 patients scheduled for elective c-section']","['warm intravenous fluid infusion and forced air warming versus forced air warming alone', 'warm intravenous (IV) fluid infusion', 'warmed IV fluid infusion and forced air warmer (Combination of active warming WI= 50) and those who received only forced air warmer', 'active warming (AW) methods namely warm IV fluid infusion and forced air warming versus forced air warming only (WA']","['Core body temperature and shivering incidence', 'incidence of shivering', 'shivering incidence']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",100.0,0.0345044,"There was a lower incidence of shivering in WI compared to WA group, which is statistically significant.
","[{'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Meghana', 'Affiliation': 'Department of Anaesthesia, KMC Mangalore, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}, {'ForeName': 'Sunil Baikadi', 'Initials': 'SB', 'LastName': 'Vasudevarao', 'Affiliation': 'Department of Anaesthesia, KMC Mangalore, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}, {'ForeName': 'Shaila S', 'Initials': 'SS', 'LastName': 'Kamath', 'Affiliation': 'Department of Anaesthesia, KMC Mangalore, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}]",Annals of African medicine,['10.4103/aam.aam_58_19']
1440,32687478,Assessing a WeChat-Based Integrative Family Intervention (WIFI) for Schizophrenia: Protocol for a Stepped-Wedge Cluster Randomized Trial.,"BACKGROUND


Schizophrenia is a persistent and debilitating mental illness, and its prognosis depends largely on supportive care and systematic treatment. In developing countries like China, families constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills, and resources. The approach to support family caregiving in an accessible, affordable, feasible, and cost-effective way remains unclear. The wide-spread use of WeChat provides a promising and cost-effective medium for support.
OBJECTIVE


We aim to present a protocol for assessing a WeChat-based integrative family intervention (WIFI) to support family caregiving for schizophrenia.
METHODS


We will develop a WIFI program that includes the following three core components: (1) psychoeducation (WeChat official account), (2) peer support (WeChat chat group), and (3) professional support (WeChat video chat). A rigorous stepped-wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with Changsha Psychiatric Hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every 2 months during an 8-month intervention period in four clusters of three communities each. Outcomes will be assessed for both family caregivers and people with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support, coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. People with schizophrenia will be assessed for their symptoms, functioning, quality of life, recovery, and rehospitalization. Cost data, such as intervention costs, health care utilization costs, and costs associated with lost productivity, will be collected. Moreover, we will collect process data, including fidelity and quality of program implementation, as well as user attitude data. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost-effectiveness ratios. Qualitative analysis will use the grounded theory approach and immersion-crystallization process.
RESULTS


The study was funded in August 2018 and approved by the institutional review board on January 15, 2019. Preliminary baseline data collection was conducted in May 2019 and completed in September 2019. The WIFI program is expected to start in September 2020.
CONCLUSIONS


This is the first study to assess a WeChat-based mHealth intervention to support family caregiving for schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for people with schizophrenia, and the approach could potentially be integrated into national policy and adapted for use in other populations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04393896; https://clinicaltrials.gov/ct2/show/NCT04393896.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18538.",2020,This is the first study to test a WeChat-based mHealth intervention to support family caregiving of schizophrenia in China.,"['Schizophrenia individuals', '12 communities affiliated with the Changsha psychiatric hospital through the free medicine delivery process in the 686 Program', 'family caregiving of schizophrenia in China']","['WeChat-based mHealth intervention', 'WeChat WeChat-based integrative family intervention (WIFI', 'WeChat-based integrative family intervention (WIFI', 'psycho-education through WeChat Official Account (WOA), 2) peer support through WeChat chat group, and 3) professional support through WeChat video chat']",[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",[],,0.0677755,This is the first study to test a WeChat-based mHealth intervention to support family caregiving of schizophrenia in China.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Social Medicine and Health Management, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Tongxin', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Social Medicine and Health Management, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Xi', 'Affiliation': 'Department of Social Medicine and Health Management, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Yilu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Social Medicine and Health Management, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Psychiatry, Changsha Psychiatric Hospital, Changsha, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, Changsha Psychiatric Hospital, Changsha, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': 'Department of Psychiatry, Changsha Psychiatric Hospital, Changsha, China.'}, {'ForeName': 'Shuiyuan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Department of Social Medicine and Health Management, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Tebes', 'Affiliation': 'Division of Prevention and Community Research, Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States.'}]",JMIR research protocols,['10.2196/18538']
1441,32696021,Preconception nutraceutical food supplementation can prevent oxidative and epigenetic DNA alterations induced by ovarian stimulation for IVF and increases pregnancy rates.,"Background


It is hypothesized that oxidative and epigenetic alterations to DNA induced by ovarian stimulation for in vitro fertilization (IVF) may be associated with an increased risk of diseases and cancer in the offspring and could possibly be attenuated by preconception food supplementation.
Methods


In a prospective randomised open-label trial, 62 patients were randomly assigned to either 30 days of preconception treatment with the nutraceutical Fertility woman ® duo (Nutriphyt, Beernem, Belgium) (group 1), this nutraceutical complemented with selenomethionine (group 2), or folic acid only (group 3). Biochemical and epigenetic effects and pregnancy rates were assessed.
Results


In all 3 groups the level of DNA oxidative damage, estimated by the concentration of 8-hydroxy- 2-deoxyguanosine over creatinine in early morning urine, and the concentration of homocysteine in the blood decreased after treatment. In group 2, the degree of methylation of the cancer-associated CpG2 dinucleotide of the human Telomerase Reverse Transcriptase (hTERT) promoter region, assessed by pyrosequence in follicular cells obtained at oocyte pick-up, was 18% lower than that of group 3. The pregnancy rate, including the transfer of fresh and frozen embryos, was significantly higher in group 2 (50%) than in group 3 (6%) with the result in group 1 being intermediate (30%).
Conclusion


The results suggest that preconception food supplementation using a specific nutraceutical significantly reduces oxidative and epigenetic DNA changes to follicular cells of women treated by IVF, and may optimize gene expression in the oocytes, thus increasing the pregnancy rate per cycle of ovarian stimulation.",2020,"In all 3 groups the level of DNA oxidative damage, estimated by the concentration of 8-hydroxy- 2-deoxyguanosine over creatinine in early morning urine, and the concentration of homocysteine in the blood decreased after treatment.",['62 patients'],"['preconception treatment with the nutraceutical Fertility woman ® duo (Nutriphyt, Beernem, Belgium', 'selenomethionine (group 2), or folic acid']","['Biochemical and epigenetic effects and pregnancy rates', 'level of DNA oxidative damage', 'oxidative and epigenetic DNA changes to follicular cells', 'degree of methylation of the cancer-associated CpG2 dinucleotide of the human Telomerase Reverse Transcriptase (hTERT) promoter region', 'pregnancy rate, including the transfer of fresh and frozen embryos']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0034616', 'cui_str': 'Selenomethionine Se 75'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007072', 'cui_str': 'glucarpidase'}, {'cui': 'C0012476', 'cui_str': 'Dinucleoside Phosphates'}, {'cui': 'C0754515', 'cui_str': 'TERT protein, human'}, {'cui': 'C0033413', 'cui_str': 'Genetic promotor region'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0440733', 'cui_str': 'Frozen embryo'}]",62.0,0.135308,"In all 3 groups the level of DNA oxidative damage, estimated by the concentration of 8-hydroxy- 2-deoxyguanosine over creatinine in early morning urine, and the concentration of homocysteine in the blood decreased after treatment.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Decleer', 'Affiliation': 'Fertility-Belgium Clinic, Weststraat, 16-18, B-9880 Aalter, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Comhaire', 'Affiliation': 'Fertility-Belgium Clinic, Weststraat, 16-18, B-9880 Aalter, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'De Clerck', 'Affiliation': 'Lab Protein Science, Proteomics and Epigenetic Signaling, Department of Biomedical Sciences, University Antwerp, Campus Drie Eiken, Universiteitsplein 1, B-2610 Wilrijk, Belgium.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Vanden Berghe', 'Affiliation': 'Lab Protein Science, Proteomics and Epigenetic Signaling, Department of Biomedical Sciences, University Antwerp, Campus Drie Eiken, Universiteitsplein 1, B-2610 Wilrijk, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Devriendt', 'Affiliation': 'Pures Ltd., Kasteelhoek 12, B-8730 Beernem, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Osmanagaoglu', 'Affiliation': 'Centre for Fertility, AZ Jan Palfijn Gent, Watersportlaan 5, B-9000 Gent, Belgium.'}]","Facts, views & vision in ObGyn",[]
1442,32691499,Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program.,"This study compared initiation of insulin and other antihyperglycaemic agents (AHAs) with canagliflozin versus placebo for participants with type 2 diabetes and a history/high risk of cardiovascular disease in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program. After 1 year, fewer participants treated with canagliflozin versus placebo initiated any AHA (7% vs. 16%), insulin (3% vs. 9%) or any non-insulin AHA (5% vs. 12%) (P < .001 for all); overall AHA initiation rates increased over time but were consistently lower with canagliflozin compared with placebo. During the study, the likelihood of initiating insulin was 2.7 times lower for participants treated with canagliflozin compared with placebo (hazard ratio, 0.37; 95% CI: 0.31, 0.43; P < .001). The time difference between 10% of patients in the canagliflozin and placebo groups being initiated on insulin from the beginning of the trial was about 2 years. Time to initiation of other AHAs, including metformin, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists and sulphonylureas, was also delayed for canagliflozin versus placebo (P < .001 for each). Compared with placebo, canagliflozin delayed the need for initiation of other AHAs and delayed time to insulin therapy, an outcome that is important to many people with diabetes.",2020,"Compared with placebo, canagliflozin delayed the need for initiation of other AHAs and delayed time to insulin therapy, an outcome that is important to many people with diabetes.",['participants with type 2 diabetes and a history/high risk of cardiovascular disease in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program'],"['insulin and other AHAs with canagliflozin versus placebo', 'canagliflozin', 'placebo, canagliflozin', 'canagliflozin versus placebo', 'placebo']","['overall AHA initiation rates', 'likelihood of initiating insulin']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.476696,"Compared with placebo, canagliflozin delayed the need for initiation of other AHAs and delayed time to insulin therapy, an outcome that is important to many people with diabetes.","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Wysham', 'Affiliation': 'University of Washington, Spokane, Washington, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Slee', 'Affiliation': 'Axio Research, Seattle, Washington, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alba', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14143']
1443,32691513,Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index ≥27 kg/m 2 .,"AIM


The DEPICT-1 and -2 studies (NCT02268214, NCT02460978) evaluated the efficacy and safety of dapagliflozin in individuals with type 1 diabetes who were receiving intensive insulin therapy. The DEPICT-1 and -2 studies (NCT02268214, NCT02460978) evaluated the efficacy and safety of dapagliflozin in individuals with type 1 diabetes. This post-hoc study investigated the safety and efficacy of dapagliflozin in individuals with BMI ≥27 kg/m 2  to assess if the benefit/risk ratio associated with dapagliflozin treatment can be further improved than that observed in the overall DEPICT population.
METHODS


Changes in glycated haemoglobin (HbA1c) and body weight, percentage change in daily insulin dose and proportion of participants achieving HbA1c reduction ≥0.5% without severe hypoglycaemia were evaluated at weeks 24 and 52. Changes in mean interstitial glucose, mean amplitude of glycaemic excursions and time in target glycaemic range were evaluated at week 24. Safety was assessed until week 56.
RESULTS


Week-52 adjusted mean (SE) change from baseline for HbA1c was -0.26% (0.05) with dapagliflozin versus +0.08% (0.05) with placebo and for body weight was -2.74 kg (0.25) with dapagliflozin versus +0.81 kg (0.26) with placebo. Mean (SE) percentage change in daily insulin dose was -10.5% (1.23) with dapagliflozin versus -1.4% (1.36) with placebo. Time spent in target glycaemic range increased by 2.2 h/day versus placebo. Dapagliflozin was well tolerated, with fewer participants experiencing diabetic ketoacidosis (dapagliflozin, 1.7%; placebo, 1.0%) than dapagliflozin 5 mg receiving participants in the pooled DEPICT populations.
CONCLUSIONS


Compared with the pooled DEPICT population, the benefit/risk profile of adjunct dapagliflozin therapy was more favourable in individuals with type 1 diabetes with body mass index ≥27 kg/m 2  because of the reduced risk of diabetic ketoacidosis in this population.",2020,Week-52 adjusted mean (SE) change from baseline for HbA1c was -0.26% (0.05) with dapagliflozin versus +0.08% (0.05) with placebo and for body weight was -2.74,"['Individuals with Type 1 Diabetes and BMI ≥27 kg/m 2 ', 'individuals with BMI ≥27 kg/m 2  ', 'individuals with type 1 diabetes who were receiving intensive insulin therapy']","['dapagliflozin therapy', 'Dapagliflozin', 'dapagliflozin', 'placebo']","['Safety', 'tolerated', 'Time spent in target glycaemic range', 'Mean [SE] percent change in daily insulin dose', 'diabetic ketoacidosis', 'efficacy and safety', 'safety and efficacy', 'mean interstitial glucose, mean amplitude of glycaemic excursions, and time in target glycaemic range', 'HbA1c and body weight, percent change in daily insulin dose and proportion of participants achieving HbA1c reduction ≥0.5% without severe hypoglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",,0.178292,Week-52 adjusted mean (SE) change from baseline for HbA1c was -0.26% (0.05) with dapagliflozin versus +0.08% (0.05) with placebo and for body weight was -2.74,"[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Centre Munich, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Troels Krarup', 'Initials': 'TK', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Repetto', 'Affiliation': 'Global Medical Affairs, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Markus Florian', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'Diabetes Medical Department, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thoren', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14144']
1444,32688457,[The application of amodified scalp retractor in the craniotomy for intracranial aneurysms].,"Objective:  To investigate the application of a modified scalp retractor in the craniotomy for intracranial aneurysms withlateral supraorbital approach.  Methods:  From January 2019 to April 2020, a total of 32 patients with anterior circulation aneurysms clipping by superior lateral orbital approach were selected from Beijing Tiantan Hospital and Peking University International Hospital. The subjects were randomly divided into the traditional scalp retractor group and the modified scalp retractor group utilizing a random number table, with 16 patients in each group. The number of intraoperative retractor adjustment, incision length, postoperative scalp necrosis rate, postoperative wound healing grade, postoperative neurosurgical satisfaction score and patients' satisfaction score for incision were compared between the two groups.  Results:  The number of retractor adjustment in the modified scalp retractors group was significantly less than that in the traditional scalp retractor group (10.1±2.2 vs 14.2±3.6,  P< 0.05) . Incision length was also significantly shorter than that of the conventional scalp retractor group ( (10.1±1.0) cm vs (13.9±0.9) cm,  P< 0.05) .Neurosurgeons were significantly more satisfied with modified scalp retractors than the traditional scalp retractors (8.1±0.9 vs 6.0±0.9,  P< 0.05). There was no significant difference in postoperative scalp necrosis rate between two groups ( P> 0.05).  Conclusion:  The modified scalp retractor group is superior to the traditional scalp retractor group in the craniotomy for intracranial aneurysms with later supraorbital approach, with shorter in cision, less retractor adjustment and shorter surgical time.",2020,There was no significant difference in postoperative scalp necrosis rate between two groups ( P> 0.05).  ,['32 patients with anterior circulation aneurysms clipping by superior lateral orbital approach were selected from Beijing Tiantan Hospital and Peking University International Hospital'],"['conventional scalp retractor group((10.1±1.0', 'amodified scalp retractor', 'modified scalp retractor', 'traditional scalp retractor group and the modified scalp retractor group utilizing a random number table']","[""number of intraoperative retractor adjustment, incision length, postoperative scalp necrosis rate, postoperative wound healing grade, postoperative neurosurgical satisfaction score and patients' satisfaction score for incision"", 'postoperative scalp necrosis rate', 'number of retractor adjustment', 'Incision length']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0179977', 'cui_str': 'Aneurysm clip'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0183031', 'cui_str': 'Scalp retractor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",32.0,0.0135821,There was no significant difference in postoperative scalp necrosis rate between two groups ( P> 0.05).  ,"[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Ge', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Duan', 'Affiliation': 'Department of Neurosurgery, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'C X', 'Initials': 'CX', 'LastName': 'Tan', 'Affiliation': 'Department of Neurosurgery, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'X L', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Meng', 'Affiliation': 'Department of Operating Room, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200529-01705']
1445,32696472,Cost-Effectiveness of 2 Support Models for a Healthy School Initiative.,"BACKGROUND


In school year (SY) 2014-2015, 128 schools in 24 districts and 14 states were randomly assigned to receive either onsite or online support to implement a school-based wellness program. The objective of this study was to assess the cost-effectiveness (CE) of the 2 models of implementation support: onsite and online.
METHODS


We adapted the ""ingredients method"" for the CE analysis. Using expenditure data, we tabulated the costs of relevant expense categories and allocated the appropriate proportion to determine the total costs of providing each type of support for 4 years (SY 2014-2015 through SY 2017-2018). We divided the average cost per school by the average change in school wellness policies and practices, using assessment data provided by the program provider, to calculate a CE ratio for schools in each group.
RESULTS


Findings indicate that when the program is implemented as intended, online support is, on average, approximately 1.3 times more cost-effective than onsite support at the end of 4 years.
CONCLUSIONS


By demonstrating the relative CE of 2 approaches to supporting the implementation of a school health program, this study provides further insight on more efficient interventions for improving overall school wellness.",2020,"RESULTS


Findings indicate that when the program is implemented as intended, online support is, on average, approximately 1.3 times more cost-effective than onsite support at the end of 4 years.
","['Healthy School Initiative', 'In school year (SY) 2014-2015, 128 schools in 24 districts and 14 states']",['onsite or online support to implement a school-based wellness program'],"['cost-effectiveness (CE', 'Cost-Effectiveness']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0227649,"RESULTS


Findings indicate that when the program is implemented as intended, online support is, on average, approximately 1.3 times more cost-effective than onsite support at the end of 4 years.
","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Finster', 'Affiliation': 'Senior Study Director, (matthewfinster@westat.com), Westat, Inc., 1600 Research Blvd., Rockville, MD 20850.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Feldman', 'Affiliation': 'Senior Study Director, (jillfeldman@westat.com), Westat, Inc.,1600 Research Blvd., Rockville, MD 20850.'}]",The Journal of school health,['10.1111/josh.12931']
1446,32689752,[Application value of non-invasive ventilation combined with high flow nasal cannula oxygen therapy in sequential treatment of patients with chronic obstructive pulmonary disease after mechanical ventilation].,"Objective:  To investigate the value of non-invasive ventilation (NIV) combined with high flow nasal cannula oxygen therapy (HFNCO) in sequential treatment of patients with chronic obstructive pulmonary disease after mechanical ventilation.  Methods:  Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) patients with invasive mechanical ventilation (MV) and successful withdrawal admitted into Huxi Affiliated Hospital of Jining Medical College from January 2018 to December 2019 were enrolled for perspective study. The patients were divided into treatment group ( n= 40) and control group ( n= 33) by random number table method. The treatment group was given NIV and HFNCO, the control group was given NIV treatment alone. Bedside ultrasound was used to measure the patients' diaphragmatic motion, and the differences between the two groups of patients before treatment, 24, 48 and 72 h after treatment were compared in diaphragmatic excursions during quiet breathing (DEq), diaphragmatic excursions during deep breathing(DEd), diaphragmatic shallow fast breathing index (D-RSBI), arterial oxygen partial pressure (PaO(2)), arterial partial pressure of carbon dioxide (PaCO(2)), re-tracheal intubation rate, mortality rate for 28 days and average duration of NPPV treatment within 3 days.  Results:  There were no statistically significant differences in DEq, DEd, D-RSBI, PaO(2) and PaCO(2) between the two groups before treatment (all  P> 0.05). After 24 h treatment, DEd decreased in both groups, D-RSBI increased in both groups, However, D-RSBI [(1.33±0.56) vs (1.62±0.59) times·min(-1)·mm(-1)] in the treatment group was significantly lower than the control group,  P= 0.034. After 72 h treatment, DEd [(41.4±8.1) vs (37.8±6.0) mm] was significantly higher than the control group, D-RSBI [(1.02±0.27) vs (1.22±0.43) times·min(-1)·mm(-1)] was significantly lower than the control group (all  P< 0.05). The average duration of NIV treatment time [(7.5±1.2) vs (9.3±2.6) h] in the treatment group was significantly shorter than that in the control group ( P< 0.01). There were no statistically significant differences in PaO(2), PCO(2), re-tracheal intubation rate and the mortality rate of 28 days.  Conclusion:  NIV combined with HFNCO sequential therapy can effectively relieve diaphragm fatigue and promote recovery of respiratory muscle strength, and it's better than NIV alone.",2020,"There were no statistically significant differences in DEq, DEd, D-RSBI, PaO(2) and PaCO(2) between the two groups before treatment (all  P> 0.05).","['Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) patients with invasive mechanical ventilation (MV) and successful withdrawal admitted into Huxi Affiliated Hospital of Jining Medical College from January 2018 to December 2019 were enrolled for perspective study', 'patients with chronic obstructive pulmonary disease after mechanical ventilation']","['non-invasive ventilation combined with high flow nasal cannula oxygen therapy', 'HFNCO sequential therapy', 'non-invasive ventilation (NIV) combined with high flow nasal cannula oxygen therapy (HFNCO', 'times·min(-1)·mm(-1']","['diaphragm fatigue and promote recovery of respiratory muscle strength', 'diaphragmatic excursions during quiet breathing (DEq), diaphragmatic excursions during deep breathing(DEd), diaphragmatic shallow fast breathing index (D-RSBI), arterial oxygen partial pressure (PaO(2)), arterial partial pressure of carbon dioxide (PaCO(2)), re-tracheal intubation rate, mortality rate for 28 days and average duration of NPPV treatment within 3 days', 'DEq, DEd, D-RSBI, PaO(2) and PaCO(2', 'PaO(2), PCO(2), re-tracheal intubation rate and the mortality rate of 28 days', 'average duration of NIV treatment time', 'DEd', 'D-RSBI']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0241827,"There were no statistically significant differences in DEq, DEd, D-RSBI, PaO(2) and PaCO(2) between the two groups before treatment (all  P> 0.05).","[{'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Yang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary Medicine, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Meng', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'W B', 'Initials': 'WB', 'LastName': 'Yang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'G Z', 'Initials': 'GZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'Q B', 'Initials': 'QB', 'LastName': 'Shi', 'Affiliation': 'Department of Emergency, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200306-00616']
1447,32689756,[Effect and underling mechanism of 6% hydroxyethyl starch 130/0.4 on serum albumen in trauma orthopedic patients during operation].,"Objective:  To investigate the effect of 6% hydroxyethyl starch 130/0.4(HES) on protein in severe trauma orthopedic patients after acute hemodilution.  Methods:  Fourty-eight severe trauma patients who met the inclusion criteria were selected from June 2018 to December 2018 in Yantaishan Hospital, and were randomly divided into two groups ( n= 24): group A and group B. Group A was ringer's sodium lactate control group, and group B was HES treatment group. After the tracheal intubation, the patients of group A were infused with 10% blood volume of sodium lactate ringer at 0.5 ml·kg(-1)·min(-1), and the patients in group B were infused with 10% blood volume of HES at 0.5 ml·kg(-1)·min(-1). Total protein (TP), human serum albumin (HSA), numbers of circulating endothelium cells (CEC), C-reactive protein (CRP), and serum levels of tumor necrosis factor-alpha (TNF-α), interleukin (IL)-10 and IL-6 were measured immediately after acute hemodilution (T(0)), 24 hours (T(1)) and 48 hours (T(2)) after acute hemodilution. After infusion into human body, HES bond to HSA, and fluorescence spectroscopy was used to analyze the binding relationship between HES and HSA in order to further study the effects of HES on HSA.  Results:  The HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0) of group A were (38±5) g/L, (66±5) g/L, (5.5±0.4)/0.9 μl, (24±5) μg/L, (8.9±0.8) μg/L, (44±6) μg/L, (13.6±1.4) mg/L; While at T(1) were (33±5) g/L, (60±6) g/L, (10.2±0.7)/0.9 μl, (87±9) μg/L, (38.8±2.3) μg/L, (57±7) μg/L, (23.4±2.4) mg/L. The HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0) of group B were(38±4)g/L, (66±5) g/L, (5.4±0.6)/0.9 μl, (24±6) μg/L, (9.1±0.9) μg/L, (45±6) μg/L, (13.4±1.8) mg/L; While at T(1) were (35±5)g/L, (62±5)g/L, (7.4±0.6)/0.9 μl, (70±8) μg/L, (29.5±3.1) μg/L, (72±6) μg/L, (19.7±2.2) mg/L. HSA and TP decreased at T(1) in group A as compared with T(0) ( P< 0.05), contrarily CEC increased significantly at T(1), TNF-ɑ, IL-6, IL-10 and CRP augmented at T(1) and T(2) in two groups ( P< 0.05). In comparison with the patients of group A, CEC decreased significantly at T(1) ( P< 0.05). TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2) ( P< 0.05), but IL-10 increased at T(1) and T(2) in group B ( P< 0.05). The secondary structure of HSA changed after HES was added in the HES solution. The fluorescence intensity of HSA decreased with the increase of HES concentration,which suggested that HES induced HSA fluorescence quenching. HES could bind to Trp-214 residue in HSA at a molecular ration of 1∶1.  Conclusions:  6% HES reduces the occurrence of low protein level in severe trauma patients after operation. HES could bind to Trp-214 amino acid residue in HSA and form the complex at a molecular ratio of 1∶1. The formation of HES-HSA complex increases the volume of HES, avoids the vascular leakage, protects the vascular endothelial cells, and induces anti-inflammatory immunity in the patients with capillary syndrome.",2020,"TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2)","['severe trauma orthopedic patients after acute hemodilution', 'severe trauma patients after operation', 'trauma orthopedic patients during operation', 'patients with capillary syndrome', 'Fourty-eight severe trauma patients who met the inclusion criteria were selected from June 2018 to December 2018 in Yantaishan Hospital']","['hydroxyethyl starch 130/0.4(HES', ""ringer's sodium lactate control group, and group B was HES treatment group"", 'HES', 'T(0', 'sodium lactate ringer at 0.5 ml·kg(-1)·min(-1', 'hydroxyethyl starch']","['serum albumen', 'CEC decreased significantly at T(1', 'Total protein (TP), human serum albumin (HSA), numbers of circulating endothelium cells (CEC), C-reactive protein (CRP), and serum levels of tumor necrosis factor-alpha (TNF-α), interleukin (IL)-10 and IL-6 were measured immediately after acute hemodilution (T(0)), 24 hours (T(1)) and 48 hours (T(2', 'contrarily CEC increased significantly at T(1), TNF-ɑ, IL-6, IL-10 and CRP augmented at T(1) and T(2', 'IL-10 increased at T(1) and T(2', 'TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2', 'HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0) of group B were(38±4)g/L, (66±5', 'fluorescence intensity of HSA', 'occurrence of low protein level', 'HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0142874', 'cui_str': 'Sodium lactate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018763', 'cui_str': 'Health Systems Agencies'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}]",,0.0377761,"TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2)","[{'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Qu', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'X N', 'Initials': 'XN', 'LastName': 'Yi', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Shao', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Yantaishan Hospital, Yantai 264008, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191114-02475']
1448,32692747,"Polygenic risk score for obesity and the quality, quantity, and timing of workplace food purchases: A secondary analysis from the ChooseWell 365 randomized trial.","BACKGROUND


The influence of genetic risk for obesity on food choice behaviors is unknown and may be in the causal pathway between genetic risk and weight gain. The aim of this study was to examine associations between genetic risk for obesity and food choice behaviors using objectively assessed workplace food purchases.
METHODS AND FINDINGS


This study is a secondary analysis of baseline data collected prior to the start of the ""ChooseWell 365"" health-promotion intervention randomized control trial. Participants were employees of a large hospital in Boston, MA, who enrolled in the study between September 2016 and February 2018. Cafeteria sales data, collected retrospectively for 3 months prior to enrollment, were used to track the quantity (number of items per 3 months) and timing (median time of day) of purchases, and participant surveys provided self-reported behaviors, including skipping meals and preparing meals at home. A previously validated Healthy Purchasing Score was calculated using the cafeteria traffic-light labeling system (i.e., green = healthy, yellow = less healthy, red = unhealthy) to estimate the healthfulness (quality) of employees' purchases (range, 0%-100% healthy). DNA was extracted and genotyped from blood samples. A body mass index (BMI) genome-wide polygenic score (BMIGPS) was generated by summing BMI-increasing risk alleles across the genome. Additionally, 3 polygenic risk scores (PRSs) were generated with 97 BMI variants previously identified at the genome-wide significance level (P < 5 × 10-8): (1) BMI97 (97 loci), (2) BMICNS (54 loci near genes related to central nervous system [CNS]), and (3) BMInon-CNS (43 loci not related to CNS). Multivariable linear and logistic regression tested associations of genetic risk score quartiles with workplace purchases, adjusted for age, sex, seasonality, and population structure. Associations were considered significant at P < 0.05. In 397 participants, mean age was 44.9 years, and 80.9% were female. Higher genetic risk scores were associated with higher BMI. The highest quartile of BMIGPS was associated with lower Healthy Purchasing Score (-4.8 percentage points [95% CI -8.6 to -1.0]; P = 0.02), higher quantity of food purchases (14.4 more items [95% CI -0.1 to 29.0]; P = 0.03), later time of breakfast purchases (15.0 minutes later [95% CI 1.5-28.5]; P = 0.03), and lower likelihood of preparing dinner at home (Q4 odds ratio [OR] = 0.3 [95% CI 0.1-0.9]; P = 0.03) relative to the lowest BMIGPS quartile. Compared with the lowest quartile, the highest BMICNS quartile was associated with fewer items purchased (P = 0.04), and the highest BMInon-CNS quartile was associated with purchasing breakfast at a later time (P = 0.01), skipping breakfast (P = 0.03), and not preparing breakfast (P = 0.04) or lunch (P = 0.01) at home. A limitation of this study is our data come from a relatively small sample of healthy working adults of European ancestry who volunteered to enroll in a health-promotion study, which may limit generalizability.
CONCLUSIONS


In this study, genetic risk for obesity was associated with the quality, quantity, and timing of objectively measured workplace food purchases. These findings suggest that genetic risk for obesity may influence eating behaviors that contribute to weight and could be targeted in personalized workplace wellness programs in the future.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02660086.",2020,"Compared with the lowest quartile, the highest BMICNS quartile was associated with fewer items purchased (P = 0.04), and the highest BMInon-CNS quartile was associated with purchasing breakfast at a later time (P = 0.01), skipping breakfast (P = 0.03), and not preparing breakfast (P = 0.04) or lunch (P = 0.01) at home.","['healthy working adults of European ancestry who volunteered to enroll in a health-promotion study', 'Participants were employees of a large hospital in Boston, MA, who enrolled in the study between September 2016 and February 2018', '397 participants, mean age was 44.9 years, and 80.9% were female']",[],"['higher quantity of food purchases', 'skipping breakfast', 'A body mass index (BMI) genome-wide polygenic score (BMIGPS', 'highest BMInon-CNS quartile', 'Polygenic risk score for obesity and the quality, quantity, and timing of workplace food purchases', '3 polygenic risk scores (PRSs', 'Higher genetic risk scores', 'later time of breakfast purchases', 'Healthy Purchasing Score']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.112173,"Compared with the lowest quartile, the highest BMICNS quartile was associated with fewer items purchased (P = 0.04), and the highest BMInon-CNS quartile was associated with purchasing breakfast at a later time (P = 0.01), skipping breakfast (P = 0.03), and not preparing breakfast (P = 0.04) or lunch (P = 0.01) at home.","[{'ForeName': 'Hassan S', 'Initials': 'HS', 'LastName': 'Dashti', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'McCurley', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003219']
1449,32692751,Effect of supplemental nutrition in pregnancy on offspring's risk of cardiovascular disease in young adulthood: Long-term follow-up of a cluster trial from India.,"BACKGROUND


Undernutrition during intrauterine life and early childhood is hypothesised to increase the risk of cardiovascular disease (Developmental Origins of Health and Disease Hypothesis), but experimental evidence from humans is limited. This hypothesis has major implications for control of the cardiovascular disease epidemic in South Asia (home to a quarter of world's population), where a quarter of newborns have low birth weight. We investigated whether, in an area with prevalent undernutrition, supplemental nutrition offered to pregnant women and their offspring below the age of 6 years was associated with a lower risk of cardiovascular disease in the offspring when they were young adults.
METHODS AND FINDINGS


The Hyderabad Nutrition Trial was a community-based nonrandomised controlled intervention trial conducted in 29 villages near Hyderabad, India (1987-1990). Protein-calorie food supplement was offered daily to pregnant and lactating women (2.09 MJ energy and 20-25 g protein) and their offspring (1.25 MJ energy and 8-10 g protein) until the age of six years in the 15 intervention villages, but not in the 14 control villages. A total of 1,826 participants (949 from the intervention villages and 877 from the control villages, representing 70% of the cohort) at a mean age of 21.6 years (62% males) were examined between 2009 and 2012. The mean body mass index (BMI) of the participants was 20 kg/m2 and the mean systolic blood pressure was 115 mm Hg. The age, sex, socioeconomic position, and urbanisation-adjusted effects of intervention (beta coefficients and 95% confidence intervals) on outcomes were as follows: carotid intima-media thickness, 0.01 mm (-0.01 to 0.03), p = 0.36; arterial stiffness (augmentation index), -1.1% (-2.5 to 0.3), p = 0.097; systolic blood pressure, 0.5 mm Hg (-0.6 to 1.6), p = 0.36; BMI, -0.13 kg/m2 (-0.75 to 0.09), p = 0.093; low-density lipoprotein (LDL) cholesterol, 0.06 mmol/L (-0.07 to 0.2), p = 0.37; and fasting insulin (log), -0.06 mU/L (-0.19 to 0.07), p = 0.43. The limitations of this study include nonrandomised allocation of intervention and lack of data on compliance, and potential for selection bias due to incomplete follow-up.
CONCLUSIONS


Our results showed that in an area with prevalent undernutrition, protein-calorie food supplements offered to pregnant women and their offspring below the age of 6 years were not associated with lower levels of cardiovascular risk factors among offspring when they were young adults. Our findings, coupled with evidence from other intervention studies to date, suggest that policy makers should attach limited value to cardiovascular health benefits of maternal and child protein-calorie food supplementation programmes.",2020,"The Hyderabad Nutrition Trial was a community-based nonrandomised controlled intervention trial conducted in 29 villages near Hyderabad, India (1987-1990).","['pregnant women and their offspring below the age of 6 years was associated with a lower risk of cardiovascular disease in the offspring when they were young adults', 'young adulthood', '1,826 participants (949 from the intervention villages and 877 from the control villages, representing 70% of the cohort) at a mean age of 21.6 years (62% males) were examined between 2009 and 2012', 'pregnant and lactating women (2.09 MJ energy and 20-25 g protein) and their offspring (1.25 MJ energy and 8-10 g protein) until the age of six years in the 15 intervention villages, but not in the 14 control villages', '29 villages near Hyderabad, India (1987-1990']","['supplemental nutrition', 'Protein-calorie food supplement']","['mean systolic blood pressure', 'mean body mass index (BMI', 'cardiovascular risk factors', 'arterial stiffness (augmentation index', 'fasting insulin', 'systolic blood pressure', 'low-density lipoprotein (LDL) cholesterol']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0456591', 'cui_str': '1987'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",1826.0,0.0584498,"The Hyderabad Nutrition Trial was a community-based nonrandomised controlled intervention trial conducted in 29 villages near Hyderabad, India (1987-1990).","[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, Delhi, India.'}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Anthropology, University of Delhi, Delhi, India.'}, {'ForeName': 'Gagandeep Kaur', 'Initials': 'GK', 'LastName': 'Walia', 'Affiliation': 'Public Health Foundation of India, Delhi, India.'}, {'ForeName': 'Santhi', 'Initials': 'S', 'LastName': 'Bhogadi', 'Affiliation': 'National Institute of Nutrition, Hyderabad, India.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, Delhi, India.'}, {'ForeName': 'Aastha', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Public Health Foundation of India, Delhi, India.'}, {'ForeName': 'Poppy Alice Carson', 'Initials': 'PAC', 'LastName': 'Mallinson', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Bharati', 'Initials': 'B', 'LastName': 'Kulkarni', 'Affiliation': 'National Institute of Nutrition, Hyderabad, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, Delhi, India.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Davey Smith', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Radha Krishna', 'Affiliation': 'National Institute of Nutrition, Hyderabad, India.'}, {'ForeName': 'Shah', 'Initials': 'S', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Kuper', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Ben-Shlomo', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003183']
1450,32702299,"Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


This is the first randomised controlled trial for assessment of the immunogenicity and safety of a candidate non-replicating adenovirus type-5 (Ad5)-vectored COVID-19 vaccine, aiming to determine an appropriate dose of the candidate vaccine for an efficacy study.
METHODS


This randomised, double-blind, placebo-controlled, phase 2 trial of the Ad5-vectored COVID-19 vaccine was done in a single centre in Wuhan, China. Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate and were randomly assigned to receive the vaccine at a dose of 1 × 10 11  viral particles per mL or 5 × 10 10  viral particles per mL, or placebo. Investigators allocated participants at a ratio of 2:1:1 to receive a single injection intramuscularly in the arm. The randomisation list (block size 4) was generated by an independent statistician. Participants, investigators, and staff undertaking laboratory analyses were masked to group allocation. The primary endpoints for immunogenicity were the geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses. This study is registered with ClinicalTrials.gov, NCT04341389.
FINDINGS


603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020. 508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial and were randomly assigned to receive the vaccine (1 × 10 11  viral particles n=253; 5 × 10 10  viral particles n=129) or placebo (n=126). In the 1 × 10 11  and 5 × 10 10  viral particles dose groups, the RBD-specific ELISA antibodies peaked at 656·5 (95% CI 575·2-749·2) and 571·0 (467·6-697·3), with seroconversion rates at 96% (95% CI 93-98) and 97% (92-99), respectively, at day 28. Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively. Specific interferon γ enzyme-linked immunospot assay responses post vaccination were observed in 227 (90%, 95% CI 85-93) of 253 and 113 (88%, 81-92) of 129 participants in the 1 × 10 11  and 5 × 10 10  viral particles dose groups, respectively. Solicited adverse reactions were reported by 183 (72%) of 253 and 96 (74%) of 129 participants in the 1 × 10 11  and 5 × 10 10  viral particles dose groups, respectively. Severe adverse reactions were reported by 24 (9%) participants in the 1 × 10 11  viral particles dose group and one (1%) participant in the 5 × 10 10  viral particles dose group. No serious adverse reactions were documented.
INTERPRETATION


The Ad5-vectored COVID-19 vaccine at 5 × 10 10  viral particles is safe, and induced significant immune responses in the majority of recipients after a single immunisation.
FUNDING


National Key R&D Programme of China, National Science and Technology Major Project, and CanSino Biologics.",2020,"Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively.","['single centre in Wuhan, China', 'healthy adults aged 18 years or older', '508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial', 'Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate', '603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020', 'All recruited participants who received at least one dose were included in the primary and safety analyses']","['recombinant adenovirus type-5-vectored', 'vaccine at a dose of 1\u2008×\u200810 11  viral particles per mL or 5\u2008×\u200810 10  viral particles per mL, or placebo', 'Ad5-vectored COVID-19 vaccine', 'vaccine', 'COVID-19 vaccine', 'placebo']","['serious adverse reactions', 'Specific interferon γ enzyme-linked immunospot assay responses post vaccination', 'Severe adverse reactions', 'seroconversion rates', 'incidence of adverse reactions', 'geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses', 'Solicited adverse reactions', 'Immunogenicity and safety', 'RBD-specific ELISA antibodies']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",508.0,0.652323,"Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively.","[{'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. Electronic address: jszfc@vip.sina.com.'}, {'ForeName': 'Xu-Hua', 'Initials': 'XH', 'LastName': 'Guan', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jian-Ying', 'Initials': 'JY', 'LastName': 'Huang', 'Affiliation': 'Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Hou', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Jing-Xin', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Bei-Fang', 'Initials': 'BF', 'LastName': 'Yang', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Wen-Juan', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Shi-Po', 'Initials': 'SP', 'LastName': 'Wu', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Si-Yue', 'Initials': 'SY', 'LastName': 'Jia', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Bu-Sen', 'Initials': 'BS', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiao-Ai', 'Initials': 'XA', 'LastName': 'Qian', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Pan', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Hu-Dachuan', 'Initials': 'HD', 'LastName': 'Jiang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Deng', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Jin-Bo', 'Initials': 'JB', 'LastName': 'Gou', 'Affiliation': 'CanSino Biologics, Tianjin, China.'}, {'ForeName': 'Xue-Wen', 'Initials': 'XW', 'LastName': 'Wang', 'Affiliation': 'Shanghai Canming Medical Technology, Shanghai, China.'}, {'ForeName': 'Xing-Huan', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China. Electronic address: wangxinghuan@whu.edu.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China. Electronic address: cw0226@foxmail.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31605-6']
1451,32702298,"Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.","BACKGROUND


The pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might be curtailed by vaccination. We assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2.
METHODS


We did a phase 1/2, single-blind, randomised controlled trial in five trial sites in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY) as control. Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 at a dose of 5 × 10 10  viral particles or MenACWY as a single intramuscular injection. A protocol amendment in two of the five sites allowed prophylactic paracetamol to be administered before vaccination. Ten participants assigned to a non-randomised, unblinded ChAdOx1 nCoV-19 prime-boost group received a two-dose schedule, with the booster vaccine administered 28 days after the first dose. Humoral responses at baseline and following vaccination were assessed using a standardised total IgG ELISA against trimeric SARS-CoV-2 spike protein, a muliplexed immunoassay, three live SARS-CoV-2 neutralisation assays (a 50% plaque reduction neutralisation assay [PRNT 50 ]; a microneutralisation assay [MNA 50 , MNA 80 , and MNA 90 ]; and Marburg VN), and a pseudovirus neutralisation assay. Cellular responses were assessed using an ex-vivo interferon-γ enzyme-linked immunospot assay. The co-primary outcomes are to assess efficacy, as measured by cases of symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were done by group allocation in participants who received the vaccine. Safety was assessed over 28 days after vaccination. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. The study is ongoing, and was registered at ISRCTN, 15281137, and ClinicalTrials.gov, NCT04324606.
FINDINGS


Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised ChAdOx1 nCoV-19 prime-boost group. Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05). There were no serious adverse events related to ChAdOx1 nCoV-19. In the ChAdOx1 nCoV-19 group, spike-specific T-cell responses peaked on day 14 (median 856 spot-forming cells per million peripheral blood mononuclear cells, IQR 493-1802; n=43). Anti-spike IgG responses rose by day 28 (median 157 ELISA units [EU], 96-317; n=127), and were boosted following a second dose (639 EU, 360-792; n=10). Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 . After a booster dose, all participants had neutralising activity (nine of nine in MNA 80  at day 42 and ten of ten in Marburg VN on day 56). Neutralising antibody responses correlated strongly with antibody levels measured by ELISA (R 2 =0·67 by Marburg VN; p<0·001).
INTERPRETATION


ChAdOx1 nCoV-19 showed an acceptable safety profile, and homologous boosting increased antibody responses. These results, together with the induction of both humoral and cellular immune responses, support large-scale evaluation of this candidate vaccine in an ongoing phase 3 programme.
FUNDING


UK Research and Innovation, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research (NIHR), NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and the German Center for Infection Research (DZIF), Partner site Gießen-Marburg-Langen.",2020,Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 .,"['n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised', 'Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either', 'Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms']","['ChAdOx1 nCoV-19 at a dose of 5', 'ChAdOx1 nCoV-19 vaccine against SARS-CoV-2', 'vaccine', 'ChAdOx1 nCoV-19 prime-boost group', 'chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY', 'ChAdOx1 nCoV-19']","['pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05', 'Safety', 'Safety and immunogenicity', 'spike-specific T-cell responses', 'Neutralising antibody responses', 'antibody responses', 'safety, reactogenicity, and cellular and humoral immune responses', 'Humoral responses', 'safety, reactogenicity, and immunogenicity', 'Local and systemic reactions', 'Neutralising antibody responses against SARS-CoV-2', 'neutralising activity', 'symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events']","[{'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008111', 'cui_str': 'Pan troglodytes'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687681', 'cui_str': 'Feeling feverish'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1077.0,0.295654,Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 .,"[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Belij-Rammerstorfer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'National Infection Service, Public Health England, Salisbury, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heath', 'Affiliation': ""Vaccine Institute, St George's University, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Rajeka', 'Initials': 'R', 'LastName': 'Lazarus', 'Affiliation': 'Department of Microbiology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Pollock', 'Affiliation': 'NIHR Imperial Clinical Research Facility, Imperial College London, London, UK.'}, {'ForeName': 'Maheshi', 'Initials': 'M', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tarrant', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: andrew.pollard@paediatrics.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31604-4']
1452,32701954,Effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among UK adolescents: A cluster randomised controlled trial.,"BACKGROUND


Less than 20% of adolescents globally meet recommended levels of physical activity, and not meeting these recommended levels is associated with social disadvantage and rising disease risk. The determinants of physical activity in adolescents are multilevel and poorly understood, but the school's social environment likely plays an important role. We conducted a cluster randomised controlled trial to assess the effectiveness of a school-based programme (GoActive) to increase moderate-to-vigorous physical activity (MVPA) among adolescents.
METHODS AND FINDINGS


Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion. Within participating schools (n = 16), all Year 9 students were eligible and invited to participate. Participants were 2,862 13- to 14-year-olds (84% of eligible students). After baseline assessment, schools were computer-randomised, stratified by school-level pupil premium funding (below/above county-specific median) and county (control: 8 schools, 1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43]). Measurement staff were blinded to allocation. The iteratively developed, feasibility-tested 12-week intervention, aligned with self-determination theory, trained older adolescent mentors and in-class peer-leaders to encourage classes to conduct 2 new weekly activities. Students and classes gained points and rewards for engaging in any activity in or out of school. The primary outcome was average daily minutes of accelerometer-assessed MVPA at 10-month follow-up; a mixed-methods process evaluation evaluated implementation. Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5%). At 10 months, there was a mean (SD) decrease in MVPA of 8.3 (19.3) minutes in the control group and 10.4 (22.7) minutes in the intervention group (baseline-adjusted difference [95% confidence interval] -1.91 minutes [-5.53 to 1.70], p = 0.316). The programme cost £13 per student compared with control; it was not cost-effective. Overall, 62.9% of students and 87.3% of mentors reported that GoActive was fun. Teachers and mentors commented that their roles in programme delivery were unclear. Implementation fidelity was low. The main methodological limitation of this study was the relatively affluent and ethnically homogeneous sample.
CONCLUSIONS


In this study, we observed that a rigorously developed school-based intervention was no more effective than standard school practice at preventing declines in adolescent physical activity. Interdisciplinary research is required to understand educational-setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN31583496.",2020,The programme cost £13 per student compared with control; it was not cost-effective.,"['1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43', 'Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion', 'Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5', 'Within participating schools (n = 16), all Year 9 students were eligible and invited to participate', 'UK adolescents', 'Participants were 2,862 13- to 14-year-olds (84% of eligible students', 'adolescents']","['school-based programme (GoActive', 'GoActive intervention']","['average daily minutes of accelerometer-assessed MVPA', 'physical activity', 'Effectiveness and cost-effectiveness', 'moderate-to-vigorous physical activity (MVPA', 'mean (SD) decrease in MVPA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0454843', 'cui_str': 'Cambridgeshire'}, {'cui': 'C0454853', 'cui_str': 'Essex'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",2862.0,0.114617,The programme cost £13 per student compared with control; it was not cost-effective.,"[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Corder', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Jong', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Foubister', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Helen Elizabeth', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Wells', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sofie M', 'Initials': 'SM', 'LastName': 'Armitage', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Caroline H D', 'Initials': 'CHD', 'LastName': 'Croxson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vignoles', 'Affiliation': 'Faculty of Education, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003210']
1453,32694318,"Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-based Cognitive Therapy for Chronic Low Back Pain.","OBJECTIVES


This study evaluated theoretically derived mechanisms and common therapeutic factors to test their role in accounting for pain-related outcome change during group-delivered cognitive therapy, mindfulness meditation, and mindfulness-based cognitive therapy for chronic low back pain.
METHODS


A secondary analysis of a pilot randomized controlled trial was used to explore the primary mechanisms of pretreatment to posttreatment changes in pain control beliefs, mindful observing, and pain catastrophizing, and the secondary common factor mechanisms of therapeutic alliance, group cohesion, and amount of at-home skill practice during treatment. The primary outcome was pain interference; pain intensity was a secondary outcome.
RESULTS


Large effect size changes in the 3 primary mechanisms and the outcome variables were found across the conditions. Across all 3 treatment conditions, change in pain control beliefs and pain catastrophizing were significantly associated with improved pain interference, but not pain intensity. Therapeutic alliance was significantly associated with pain intensity improvement and change in the therapy-specific mechanisms across the 3 conditions. Mindful observing, group cohesion, and amount of at-home practice were not significantly associated with changes in the outcomes.
DISCUSSION


Cognitive therapy, mindfulness meditation, and mindfulness-based cognitive therapy for chronic low back pain were all associated with significant changes in the primary mechanisms to a similar degree. Change in perceived pain control and pain catastrophizing emerged as potential ""meta-mechanisms"" that might be a shared pathway that contributes to improved pain-related outcomes across treatments. Further, strong working alliance may represent a critical therapeutic process that both promotes and interacts with therapeutic techniques to influence outcome.",2020,"Across all three treatment conditions, change in pain control beliefs and pain catastrophizing were significantly associated with improved pain interference, but not pain intensity.",['Chronic Low Back Pain'],"['cognitive therapy (CT), mindfulness meditation (MM) and mindfulness-based cognitive therapy (MBCT', 'Mindfulness Meditation, Cognitive Therapy, and Mindfulness-based Cognitive Therapy']","['pain control beliefs, mindful observing, and pain catastrophizing', 'pain intensity', 'pain interference; pain intensity', 'pain control beliefs and pain catastrophizing', 'pain interference']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",3.0,0.0798335,"Across all three treatment conditions, change in pain control beliefs and pain catastrophizing were significantly associated with improved pain interference, but not pain intensity.","[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'L Charles', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, AL.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Barnier', 'Affiliation': 'Department of Cognitive Science, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Mattingley', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000862']
1454,32698912,Intake of  Calanus finmarchicus  oil for 12 weeks improves omega-3 index in healthy older subjects engaging in an exercise programme.,"The n-3 PUFA, EPA and DHA, play an important role in human health. As the intake of EPA and DHA from the diet is often inadequate, supplementation of those fatty acids is recommended. A novel source of n-3 PUFA is Calanus finmarchicus oil (CO) which contains fatty acids mainly bound in wax esters. To date, no data are available on the effects of long-term intake of this marine oil on n-3 PUFA blood levels. Therefore, the aim of this study was to evaluate the effect of CO on the n-3 PUFA blood levels using the omega-3 index (O3I). The data originate from a larger randomised controlled trial. For this analysis, samples from seventy-two participants (59·2 (sd 6·2) years, BMI 27·7 (sd 5·28) kg/m2) were analysed. Of those, thirty-six performed 2×/week exercise and received 2 g of CO, which provided 124 mg stearidonic acid (SDA), 109 mg EPA and 87 mg DHA daily (EXCO group), while the other group performed exercise only (EX group) and served as a control for this analysis. The O3I increased from 6·07 (sd 1·29) % at baseline to 7·37 (sd 1·10) % after 12 weeks within the EXCO group (P < 0·001), while there were no significant changes in the EX group (6·01 (sd 1·26)-6·15 (sd 1·32) %, P = 0·238). These data provide first evidence that wax ester-bound n-3 PUFA from CO can significantly increase the O3I despite relatively low EPA + DHA amounts. Further, the effects of exercise could be excluded.",2020,"The O3I increased from 6.07 ± 1.29% at baseline to 7.37 ± 1.10% after 12 weeks within the EXCO group (p<0.001), while there were no significant changes in the EX group (6.01 ± 1.26% to 6.15 ± 1.32%, p=0.238).","['human health', '72 participants (59.2 ± 6.2 years, BMI was 27.7 ± 5.28 kg/m2) were analyzed', 'healthy older subjects engaging in an exercise program']","['n-3 PUFAs', 'CO, which provided 124 mg stearidonic acid (SDA), 109 mg EPA, and 87 mg DHA daily (EXCO group), while the other group performed exercise only (EX group) and served as a control for this analysis', 'CO', 'Calanus finmarchicus  oil intake', 'omega-3 polyunsaturated fatty acids (n-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'EXCO']",['n-3 PUFA blood levels'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0075197', 'cui_str': 'stearidonic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0556200', 'cui_str': 'Oil intake'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0342047,"The O3I increased from 6.07 ± 1.29% at baseline to 7.37 ± 1.10% after 12 weeks within the EXCO group (p<0.001), while there were no significant changes in the EX group (6.01 ± 1.26% to 6.15 ± 1.32%, p=0.238).","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wasserfurth', 'Affiliation': 'Faculty of Natural Sciences, Institute of Food Science and Human Nutrition, Leibniz University Hannover, 30167Hannover, Germany.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Nebl', 'Affiliation': 'Faculty of Natural Sciences, Institute of Food Science and Human Nutrition, Leibniz University Hannover, 30167Hannover, Germany.'}, {'ForeName': 'Tim Konstantin', 'Initials': 'TK', 'LastName': 'Boßlau', 'Affiliation': 'Department of Exercise Physiology and Sports Therapy, Institute of Sports Science, Justus-Liebig-University Giessen, 35394Giessen, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Krüger', 'Affiliation': 'Department of Exercise Physiology and Sports Therapy, Institute of Sports Science, Justus-Liebig-University Giessen, 35394Giessen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Faculty of Natural Sciences, Institute of Food Science and Human Nutrition, Leibniz University Hannover, 30167Hannover, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Schuchardt', 'Affiliation': 'Faculty of Natural Sciences, Institute of Food Science and Human Nutrition, Leibniz University Hannover, 30167Hannover, Germany.'}]",The British journal of nutrition,['10.1017/S0007114520002809']
1455,32701900,"The Effects of Nicotine on Cortical Excitability After Exercise: A Double-Blind Randomized, Placebo-controlled, Crossover Study.","PURPOSE


The use of smokeless tobacco/nicotine products is common among athletes, but clear evidence for their positive or negative effect on sports performance is lacking. Nicotine is a psychoactive substance involved in numerous neuronal processes including cortical excitability. The aim of this study was to evaluate its effect on cortical excitability associated with aerobic exercise in nicotine-naive healthy volunteers.
METHODS


Ten nicotine-naive healthy volunteers were recruited for this double-blind, randomized, crossover study to compare the effect of snus (8 mg nicotine), an oral, smokeless tobacco product, to placebo on cortical excitability before and after aerobic exercise. Transcranial magnetic stimulation (TMS) was used to measure changes in corticomotor excitability (motor-evoked potentials, MEPs) and electromyography of leg muscles during maximal voluntary contractions (MVC) to assess changes in muscle contractions. Before and after aerobic exercise and with or without nicotine treatment, MEPs and MVCs were measured.
RESULTS


Analysis of TMS data showed lower motor cortex activation (lower MEP amplitude) after snus administration compared with placebo, whereas electromyography data showed no difference in muscle contraction between snus and placebo treatment.
CONCLUSIONS


These findings suggest a general reduction in cortical excitability, without no relevant effect on physical performance.",2020,"RESULTS


Analysis of TMS data showed lower motor cortex activation (lower MEP amplitude) after snus administration compared with placebo, whereas electromyography data showed no difference in muscle contraction between snus and placebo treatment.
","['nicotine-naive healthy volunteers', 'Ten nicotine-naive healthy volunteers']","['Placebo', 'aerobic exercise and with or without nicotine', 'oral, smokeless tobacco product, to placebo', 'placebo', 'snus (8 mg nicotine', 'Transcranial magnetic stimulation (TMS', 'smokeless tobacco/nicotine products', 'Nicotine', 'aerobic exercise']","['muscle contraction', 'Cortical Excitability', 'motor cortex activation', 'cortical excitability', 'corticomotor excitability (motor-evoked potentials, MEPs) and electromyography of leg muscles', 'physical performance']","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C4288198', 'cui_str': 'Snus'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.62248,"RESULTS


Analysis of TMS data showed lower motor cortex activation (lower MEP amplitude) after snus administration compared with placebo, whereas electromyography data showed no difference in muscle contraction between snus and placebo treatment.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zandonai', 'Affiliation': 'From the Department of Pharmacology, Pediatrics and Organic Chemistry, Miguel Hernández University, Elche.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pizzolato', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruseghini', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Chiamulera', 'Affiliation': 'Neuropsychopharmacology Laboratory, Department of Diagnostic and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cesari', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001246']
1456,32701901,Lurasidone Efficacy in Mixed Depressive States: A Comparison of Standard Rating Scales to the Koukopoulos Mixed Depression Rating Scale.,"INTRODUCTION


A new mood rating scale for mixed states of depression along with manic-like excitatory symptoms, the Koukopoulos Mixed Depression Rating Scale (KMDRS), was assessed in a post hoc analysis of a randomized clinical trial of lurasidone versus placebo in major depressive disorder (MDD) with mixed features.
METHODS


The KMDRS was compared with the Montgomery Asberg Depression Rating Scale (MADRS) and the Young Mania Rating Scale (YMRS). Item weighting was performed and compared with an original KMDRS validation data set. Weighting was used to provide imputed KMDRS scores in the lurasidone study, based on observed MADRS and YMRS scores.
RESULTS


Standardized effect sizes were larger for MADRS (0.61) and YMRS (0.79) than for KMDRS (0.44, Cohen d).
CONCLUSIONS


This analysis did not find that the KMDRS produced a larger effect size than the MADRS in Diagnostic and Statistical Manual for Mental Disorder-5 (DSM-5) defined MDD with mixed features. The lower utility of KMDRS may be due to the imputed nature of this analysis, or also to the DSM-5 defined patient population, which may reflect mixed hypomania rather than mixed depression.",2020,This analysis did not find that the KMDRS produced a larger effect size than the MADRS in Diagnostic and Statistical Manual for Mental Disorder-5 (DSM-5) defined MDD with mixed features.,"['Mixed Depressive States', 'major depressive disorder (MDD) with mixed features']","['lurasidone versus placebo', 'KMDRS']","['Koukopoulos Mixed Depression Rating Scale (KMDRS', 'Montgomery Asberg Depression Rating Scale (MADRS) and the Young Mania Rating Scale (YMRS', 'Koukopoulos Mixed Depression Rating Scale']","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}]",,0.0448118,This analysis did not find that the KMDRS produced a larger effect size than the MADRS in Diagnostic and Statistical Manual for Mental Disorder-5 (DSM-5) defined MDD with mixed features.,"[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Vöhringer', 'Affiliation': 'From the Department of Psychiatry, Tufts University School of Medicine, Boston, MA.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Sani', 'Affiliation': 'From the Department of Psychiatry, Tufts University School of Medicine, Boston, MA.'}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Barroilhet', 'Affiliation': 'From the Department of Psychiatry, Tufts University School of Medicine, Boston, MA.'}, {'ForeName': 'Yongcai', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Sunovion Pharmaceuticals, Marlborough.'}, {'ForeName': 'S Nassir', 'Initials': 'SN', 'LastName': 'Ghaemi', 'Affiliation': 'From the Department of Psychiatry, Tufts University School of Medicine, Boston, MA.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001261']
1457,32701903,Is Sitagliptin Effective for Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients? A Double-blind Placebo-controlled Clinical Trial.,"PURPOSE/BACKGROUND


The mortality rate of patients with schizophrenia due to metabolic disturbances is high. Our aim is to survey the effects of sitagliptin on metabolic disturbances associated with olanzapine in patients with schizophrenia.
METHODS/PROCEDURES


In this 12-week double-blind placebo-controlled clinical trial, 71 patients taking olanzapine (10 to 30 mg) for at least 1 month were randomly allocated to enter 1 of the 2 treatment groups (olanzapine plus placebo or olanzapine plus sitagliptin). Sitagliptin was added to patients 'current medications with the dose of 100 mg/d. Physical examinations and measurement of anthropometric (body mass index and waist circumference) and laboratory parameters (fasting blood sugar, glycated hemoglobin, total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride) were measured at baseline, week 4, and week 12. The patients were assessed for any side effects of the medications in each visit.
FINDINGS/RESULTS


Sixty-one patients (30 in the sitagliptin and 31 in the placebo group) completed the trial. The anthropometric measurements at the end of the study did not differ between the 2 groups. glycated hemoglobin and total cholesterol were significantly lower in the sitagliptin group after 12 weeks. Other metabolic profile revealed either no change or minimal magnitude changes. No major side effect was reported.
IMPLICATIONS/CONCLUSIONS


Metabolic disturbances associated with olanzapine treatment in patients with schizophrenia can be modulated by sitagliptin.",2020,glycated hemoglobin and total cholesterol were significantly lower in the sitagliptin group after 12 weeks.,"['patients with schizophrenia', '71 patients taking', 'Sixty-one patients (30 in the sitagliptin and 31 in the placebo group) completed the trial', '10 to 30 mg) for at least 1 month']","['olanzapine', 'Placebo', 'Olanzapine', 'olanzapine plus placebo or olanzapine plus sitagliptin', 'Sitagliptin', 'sitagliptin', 'placebo']","['glycated hemoglobin and total cholesterol', 'Physical examinations and measurement of anthropometric (body mass index and waist circumference) and laboratory parameters (fasting blood sugar, glycated hemoglobin, total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",71.0,0.0833552,glycated hemoglobin and total cholesterol were significantly lower in the sitagliptin group after 12 weeks.,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Moghimi Sarani', 'Affiliation': 'From the Substance Abuse and Mental Health Research Center, Department of Psychiatry.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Memari', 'Affiliation': 'Research Center for Psychiatry and Behavioral Sciences, Department of Psychiatry, Shiraz University of Medical Sciences, School of Medicine, Shiraz.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushiravani', 'Affiliation': 'Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mowla', 'Affiliation': 'Research Center for Psychiatry and Behavioral Sciences, Department of Psychiatry, Shiraz University of Medical Sciences, School of Medicine, Shiraz.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001259']
1458,32710396,Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study.,"BACKGROUND


Alemtuzumab efficacy versus subcutaneous interferon-β-1a (SC IFNB-1a) was demonstrated over 2 years in patients with relapsing-remitting multiple sclerosis, with continued efficacy over 7 additional years. Alemtuzumab is included as a recommended treatment for patients with highly active disease (HAD) by the American Academy of Neurology Practice Guidelines, and the label indication in Europe was recently restricted to the treatment of HAD patients. There is currently no consensus definition for HAD, and alemtuzumab efficacy across various HAD definitions has not been explored previously.
OBJECTIVES


In this post hoc analysis, we assess the efficacy and safety of alemtuzumab in Comparison of Alemtuzumab and Rebif ®  Efficacy in Multiple Sclerosis (CARE-MS) trial patients who met criteria for at least one of four separate definitions of HAD (one primary and three alternatives). Over 2 years, alemtuzumab-treated HAD patients were compared with SC IFNB-1a-treated HAD patients, with additional 7-year follow-up in patients from the alemtuzumab arm.
METHODS


Patients in the CARE-MS studies received either alemtuzumab (baseline: 5 days; 12 months later: 3 days) or SC IFNB-1a (3 times weekly). Alemtuzumab-treated patients who enrolled in the extensions could receive additional courses ≥ 12 months apart. Four definitions of HAD were applied to assess alemtuzumab efficacy: the pre-specified primary definition (two or more relapses in the year prior to baseline and at least one gadolinium [Gd]-enhancing lesion at baseline) and three alternative definitions that focused on relapse, magnetic resonance imaging (MRI), or prior treatment response criteria. Efficacy outcomes were annualized relapse rate, change in Expanded Disability Status Scale score, 6-month confirmed disability worsening, 6-month confirmed disability improvement, MRI disease activity, and brain volume change. Adverse events were summarized for HAD patients meeting the primary definition.
RESULTS


In the pooled CARE-MS population, 208 alemtuzumab-treated patients met the primary HAD definition. Annualized relapse rate was 0.27 in years 0-2 and 0.16 in years 3-9. Over 9 years, 62% of patients were free of 6-month confirmed disability worsening, 50% had 6-month confirmed disability improvement, and median cumulative change in brain volume was - 2.15%. During year 9, 62% had no evidence of disease activity, and 69% were free of MRI disease activity. Similar efficacy outcomes were observed using an alternative relapse-driven HAD definition. For patients meeting alternative HAD definitions focused on either higher MRI lesion counts or disease activity while on prior therapy, reduced efficacy for some endpoints was seen. Safety was consistent with the overall CARE-MS population through year 9.
CONCLUSIONS


Over 9 years, alemtuzumab efficacy was maintained in CARE-MS HAD patients based on four HAD definitions. These results support intervention with alemtuzumab in patients with early indicators of HAD, including frequent relapse without high MRI activity. No safety signals were observed over 9 years that were unique to the HAD populations. CLINICALTRIALS.
GOV IDENTIFIERS


NCT00530348; NCT00548405; NCT00930553; NCT02255656.",2020,Annualized relapse rate was 0.27 in years 0-2 and 0.16 in years 3-9.,"['patients with relapsing-remitting multiple sclerosis', 'Multiple Sclerosis (CARE-MS) trial patients who met criteria for at least one of four separate definitions of HAD', 'Patients in the CARE-MS studies received either', 'Patients with Highly Active Disease', 'treated patients who enrolled in the extensions could receive additional courses ≥', 'patients with highly active disease (HAD) by the American Academy of Neurology Practice Guidelines']","['subcutaneous interferon-β-1a (SC IFNB-1a', 'Alemtuzumab', 'alemtuzumab', 'alemtuzumab (baseline: 5\xa0days; 12\xa0months later: 3\xa0days) or SC IFNB-1a']","['annualized relapse rate, change in Expanded Disability Status Scale score, 6-month confirmed disability worsening, 6-month confirmed disability improvement, MRI disease activity, and brain volume change', 'Efficacy and Safety', 'alternative relapse-driven HAD definition', 'disease activity', 'Adverse events', 'free of MRI disease activity', 'MRI lesion counts or disease activity', 'efficacy and safety', 'alemtuzumab efficacy', 'Annualized relapse rate', 'disability improvement, and median cumulative change in brain volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0162793', 'cui_str': 'Practice Guidelines as Topic'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0685088,Annualized relapse rate was 0.27 in years 0-2 and 0.16 in years 3-9.,"[{'ForeName': 'Tjalf', 'Initials': 'T', 'LastName': 'Ziemssen', 'Affiliation': 'Center of Clinical Neuroscience, University Clinic Carl Gustav Carus, Fetscherstr. 74, 01307, Dresden, Germany. Tjalf.Ziemssen@uniklinikum-dresden.de.'}, {'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Bass', 'Affiliation': 'Neurology Center of San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Berkovich', 'Affiliation': 'Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Eichau', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Hobart', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.'}, {'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, Franklin, TN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'LaGanke', 'Affiliation': 'North Central Neurology Associates, Cullman, AL, USA.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Limmroth', 'Affiliation': 'Klinik für Neurologie und Palliativmedizin, Cologne, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pelletier', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schippling', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Research, University Hospital Zürich and University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Sousa', 'Affiliation': 'Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Traboulsee', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Van Wijmeersch', 'Affiliation': 'Rehabilitation and MS-Centre Overpelt, BIOMED, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Choudhry', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Singer', 'Affiliation': 'MS Center for Innovations in Care, Missouri Baptist Medical Center, St. Louis, MO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CNS drugs,['10.1007/s40263-020-00749-x']
1459,32707342,"Inter- and Intra-individual Variation, and Limited Prognostic Utility, of Serum Alkaline Phosphatase in a Trial of Patients With Primary Sclerosing Cholangitis.","BACKGROUND & AIMS


Serum alkaline phosphatase (ALP) and the enhanced liver fibrosis (ELF) score are used as endpoints in trials of patients with primary sclerosing cholangitis (PSC). We aimed to quantify inter- and intra-individual variation in levels of ALP and the ELF score over time, and evaluated their association with fibrosis progression.
METHODS


We analyzed data from 234 patients with large-duct PSC enrolled in a 2-year, phase 2b placebo-controlled trial of simtuzumab. Participants were assessed by laboratory tests every 4 weeks, and liver biopsies collected at time of screening, week 48, and week 96.
RESULTS


Serum levels of ALP and ELF scores did not differ significantly between simtuzumab and placebo groups, so the data were pooled. Median per-patient variations in ALP between clinic visits were approximately 12% over 12 weeks, 20% over 48 weeks, and 20% over 96 weeks. Reductions, unrelated to study intervention, of more than 40% in ALP were observed in 10.9% of patients with baseline activity greater than 2-fold the upper limit of normal (ULN) and 12.5% of patients with more than 3-fold the ULN at 1 year. At 2 years, reductions of more than 40% in ALP were observed in 15.8% of patients with baseline activity greater than 2-fold the ULN and 17.9% of patients with more than 3-fold the ULN. Among the 209 patients with Ishak fibrosis stage 0-4 at baseline, serum levels of ALP did not associate with development of cirrhosis or with a 2-point increase in fibrosis stage at 2 years. The median per-patient variation in ELF scores between clinic visits was approximately 3% over 12 weeks, 4% over 48 weeks, and 4% over 96 weeks. Increased ELF scores at baseline and at weeks 12, 24 and 48, each associated with development of cirrhosis at 2 years (odds ratio >2.75; P < .01 for all timepoints). ELF scores at baseline and weeks 12, 24 and 48, also associated with a 2-point increase in fibrosis stage at 2 years (odds ratios all greater than 2; P < .01 for all timepoints).
CONCLUSIONS


In an analysis of data from patients with large-duct PSC enrolled in a prospective trial, we found large variations in serum levels of ALP, within and among patients. Serum levels of ALP did not associate with disease progression over a 2-year period. Variations in ELF score were smaller, and scores determined at multiple timepoints associated with fibrosis progression and development of cirrhosis.",2020,"RESULTS


Serum levels of ALP and ELF scores did not differ significantly between simtuzumab and placebo groups, so the data were pooled.","['Patients With Primary Sclerosing Cholangitis', 'patients with large-duct PSC', '209 patients with Ishak fibrosis stage 0-4 at baseline', '234 patients with large-duct PSC enrolled in a 2-year, phase 2b', 'patients with primary sclerosing cholangitis (PSC']","['simtuzumab', 'placebo']","['ELF scores', 'fibrosis stage', 'ALP', 'ELF score', 'upper limit of normal (ULN', 'Increased ELF scores', 'Serum levels of ALP', 'fibrosis progression and development of cirrhosis', 'serum levels of ALP', 'Serum levels of ALP and ELF scores', 'median per-patient variation in ELF scores between clinic visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C4054022', 'cui_str': 'simtuzumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",234.0,0.0822935,"RESULTS


Serum levels of ALP and ELF scores did not differ significantly between simtuzumab and placebo groups, so the data were pooled.","[{'ForeName': 'Palak J', 'Initials': 'PJ', 'LastName': 'Trivedi', 'Affiliation': 'National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, United Kingdom; University Hospitals Birmingham, Birmingham, United Kingdom; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, United Kingdom; Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Muir', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California Davis, Davis, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Crans', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Vierling', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Indra Neil', 'Initials': 'IN', 'LastName': 'Guha', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: Hirsch.hirschfield@uhn.ca.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.032']
1460,32707403,"Changes to stance limb peak, cumulative, and regional plantar foot forces among normal walking and three mobility aids in healthy older adults.","BACKGROUND


Mobility aids are commonly prescribed to offload an injured lower extremity. Device selection may impact stance foot loading patterns and foot health in clinical populations at risk of foot ulceration.
RESEARCH QUESTIONS


Two questions motivated this study: How does device selection influence peak plantar and regional (rearfoot, mid foot and forefoot) foot forces on the stance foot? Does device selection influence peak, cumulative, and regional plantar forces within a 200 m walking trial?
METHODS


Twenty-one older adults walked 200 m at self-selected pace in four randomized conditions for this prospective crossover study. Participants used a walker, crutches, wheeled knee walker (WKW), and no assistive device (control condition). Plantar forces were measured using a wireless in-shoe system (Loadsol, Novel Inc., St. Paul, MN). Repeated measures analyses of variance were used to determine differences in peak and cumulative total and regional forces among walking conditions. Paired sample t-tests compared forces during first and last 30 s epochs of each condition to determine device influence over time.
RESULTS


The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions. Crutch use had similar peak forces as control. There were no differences in the number of steps taken within devices comparing first and last epochs. Crutches had a 0.04 and 0.07 BW increase in peak net and forefoot forces during the last epoch. Walker use had 66.44 BW lower cumulative forefoot forces in the last epoch.
SIGNIFICANCE


Crutches had similar stance foot loading as normal walking while a walker lowered forefoot forces at the expense of increased steps. A WKW may be the best choice to 'protect' tissues in the stance foot from exposure to peak and cumulative forces in the forefoot region.",2020,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"['healthy older adults', 'Twenty-one older adults walked 200 m at self-selected pace']",['normal walking and three mobility aids'],"['device selection influence peak, cumulative, and regional plantar forces', 'peak net forces', 'Plantar forces', 'peak net and forefoot forces', 'stance limb peak, cumulative, and regional plantar foot forces', 'peak and cumulative total and regional forces among walking conditions', 'cumulative forefoot forces']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3495449', 'cui_str': 'Mobility aid'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",21.0,0.0456241,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Kingston', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada. Electronic address: david.kingston@usask.ca.'}, {'ForeName': 'A Gary', 'Initials': 'AG', 'LastName': 'Linassi', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada; School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: anl931@mail.usask.ca.'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Zucker-Levin', 'Affiliation': 'School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: audrey.zuckerlevin@usask.ca.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.015']
1461,32710862,Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial.,"BACKGROUND


Although gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised.
METHODS


This unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov, NCT03112018.
FINDINGS


Between Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81). No harm or adverse effects were found.
INTERPRETATION


Fresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening.
FUNDING


Bill & Melinda Gates Foundation.",2020,"347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81).","['Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis', 'Between Oct 1, 2016, and April 30, 2019', 'western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year', ' 20 facilities', '5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group', 'preterm and low-birthweight babies in Kenya and Uganda']","['provider mentoring using PRONTO simulation and team training', 'quality improvement package for intrapartum and immediate newborn care']","['fresh stillbirth and 28-day neonatal mortality', 'low-birthweight and preterm babies', 'fresh stillbirth and neonatal mortality', 'stillborn or died', 'harm or adverse effects', 'stillbirth and preterm neonatal survival']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1442824', 'cui_str': 'POU2F1 protein, human'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}]","[{'cui': 'C1260720', 'cui_str': 'Pronto'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}]","[{'cui': 'C0405334', 'cui_str': 'Fresh stillbirth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.207075,"347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81).","[{'ForeName': 'Dilys', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA. Electronic address: dilys.walker@ucsf.edu.'}, {'ForeName': 'Phelgona', 'Initials': 'P', 'LastName': 'Otieno', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Butrick', 'Affiliation': 'Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Namazzi', 'Affiliation': 'Maternal, Newborn and Child Health Centre of Excellence, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Achola', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Rikita', 'Initials': 'R', 'LastName': 'Merai', 'Affiliation': 'Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Otare', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mubiri', 'Affiliation': 'Maternal, Newborn and Child Health Centre of Excellence, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Ghosh', 'Affiliation': 'Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Santos', 'Affiliation': 'Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sloan', 'Affiliation': 'Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Waiswa', 'Affiliation': 'Maternal, Newborn and Child Health Centre of Excellence, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda; Global Health Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30232-1']
1462,32692701,Could Anise decrease the intensity of premenstrual syndrome symptoms in comparison to placebo? A double-blind randomized clinical trial.,"Background Premenstrual syndrome (PMS) has a high prevalence among women of reproductive ages but despite its high prevalence, it has no determined and absolute treatment, so far. So, the aim of the present study was to compare the effect Pimpinella Anisum (Anise) with placebo on the intensity of the symptoms of PMS. Methods The present study was a randomized double-blind controlled clinical trial. College students who were suffering from PMS and had the inclusion criteria were selected and randomly assigned into two groups of intervention (Anise) and control (placebo). Participants in the intervention group, received 110 mg capsules of Anise three times day (a total dose of 330 mg per day); the control group received similar capsules with the same dosing that contained starch. Consumption of the capsules was started 7 days before the start of the menstruation and continued until 3 days after, which was a total of 10 days during two consecutive menstruation cycles. The intensity of the symptoms of premenstrual syndrome was measured using Premenstrual Symptoms Screening Tool (PSST). To compare the intensity of the symptoms between the two study groups, generalized estimating equation statistical method was used. Results Eventually, sixty-seven 18-35 year old college students who were suffering from premenstrual syndrome were enrolled in the study. Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively. Conclusion Results of the study showed that, in general, Anise was effective in decreasing the symptoms of premenstrual syndrome in comparison to placebo.",2020,"Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively.","['Eventually, sixty-seven 18-35\u2006year old college students who were suffering from premenstrual syndrome were enrolled in the study', 'College students who were suffering from PMS and had the inclusion criteria']","['control group received similar capsules with the same dosing that contained starch', 'intervention (Anise) and control (placebo', 'placebo']","['mean score of the intensity of the syndrome', 'symptoms of premenstrual syndrome', 'intensity of premenstrual syndrome symptoms', 'intensity of the symptoms of premenstrual syndrome']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1857276', 'cui_str': 'Trichohepatoenteric syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}]",,0.376752,"Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farahmand', 'Affiliation': 'Research Institute for Endocrine Sciences, Reproductive Endocrinology Research Center, Shahid Beheshti University of Medical Sciences Tehran, Iran (Islamic Republic of).'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Ramezani Tehrani', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Amin', 'Affiliation': 'Department of Pharmacognosy, faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Negarandeh', 'Affiliation': 'Nursing & Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0077']
1463,32693214,Biomarkers of Type 2 Airway Inflammation as Predictors of Loss of Asthma Control During Step-Down Therapy for Well-Controlled Disease: The Long-Acting Beta-Agonist Step-Down Study (LASST).,"BACKGROUND


Biomarkers that can predict loss of asthma control among patients being considered for step-down therapy in well-controlled disease are lacking.
OBJECTIVE


To evaluate whether baseline biomarkers of type 2 airway inflammation and/or serial measurement of fractional exhaled nitric oxide (Feno) predict loss of asthma control as therapy is stepped down.
METHODS


In subanalyses of a multicenter randomized, double-blind, parallel 3-arm trial comparing strategies for step-down therapy in well-controlled asthma (Long-Acting Beta-Agonist Step-Down Study), we assessed whether baseline atopy as determined by serum aeroallergen allergy screening test (Phadiatop), baseline serum eosinophil peroxidase, or baseline or serial Feno measurements during follow-up predicted the time to loss of asthma control among participants. Loss of asthma control was defined in the study protocol. We analyzed these associations in adjusted models including all participants, after testing for interactions with assignment to each of the 3 treatment groups (continuation of stable dose of combination inhaled corticosteroid-long-acting beta-agonist, step-down of inhaled corticosteroid, or discontinuation of long-acting bronchodilator).
RESULTS


Four hundred forty-seven of the 553 Long-Acting Beta-Agonist Step-Down Study participants who were randomized to 1 of 3 treatment arms and had at least 1 biomarker measurement were included in this analysis. At baseline, higher levels of Feno were significantly associated with greater levels of multiallergen IgE levels (P < .001), but not with serum eosinophil peroxidase (P = .742). Among all participants as a group, elevations in baseline biomarkers were not predictive of a higher risk of treatment failure. In addition, Feno levels measured serially at 6-week intervals demonstrated that compared with participants with low levels (<25 parts per billion), those with intermediate (25-50 parts per billion) and high (>50 parts per billion) levels did not have significantly increased likelihood of subsequent treatment failure (hazard ratios, 1.03 [95% CI, 0.59-1.78] and 1.29 [95% CI, 0.65-2.54], respectively). There were no significant interactions of treatment group and baseline biomarkers.
CONCLUSIONS


In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of Feno are strong predictors of treatment failure.",2020,"In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of FeNO are strong predictors of treatment failure.",['Four hundred and forty-seven of the 553 LASST participants who were randomized to one of 3 treatment arms and had at least one biomarker measurement were included in this analysis'],"['combination ICS-LABA, step-down of inhaled corticosteroid (ICS), or discontinuation of long acting bronchodilator (LABA']","['levels of FeNO', 'likelihood of subsequent treatment failure', 'FeNO levels', 'levels of multi-allergen IgE levels', 'serum aeroallergen allergy screening test (Phadiatop), baseline serum eosinophil peroxidase (EpX), or baseline or serial FeNO measurements', 'Loss of asthma control']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C1273434', 'cui_str': 'Allergy screening test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",553.0,0.395791,"In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of FeNO are strong predictors of treatment failure.","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Bose', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY; Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bime', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Henderson', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Blake', 'Affiliation': ""Nemours Children's Health System, Jacksonville, Fla.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'DiMango', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Irvin', 'Affiliation': 'University of Vermont, Burlington, Vt.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Reibman', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: linda.rogers@mssm.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.067']
1464,32693310,The influence of type of feedback during tablet-based delivery of intensive treatment for childhood apraxia of speech.,"PURPOSE


One of the key principles of motor learning supports using knowledge of results feedback (KR, i.e., whether a response was correct / incorrect only) during high intensity motor practice, rather than knowledge of performance (KP, i.e., whether and how a response was correct/incorrect). In the future, mobile technology equipped with automatic speech recognition (ASR) could provide KR feedback, enabling this practice to move outside the clinic, supplementing speech pathology sessions and reducing burden on already stretched speech-language pathology resources. Here, we employ a randomized controlled trial design to test the impact of KR vs KP feedback on children's response to the Nuffield Dyspraxia Programme 3, delivered through an android tablet. At the time of testing, ASR was not feasible and so correctness of responses was decided by the treating clinician.
METHOD


Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS. Both groups attended a university clinic for 1-hr therapy sessions 4 days a week for 3 weeks. One group received high frequency feedback comprised of both KR and KP, in the style of traditional, face-to-face intensive intervention on all days. The other group received high frequency KR + KP feedback on 1 day per week and high frequency KR feedback on the other 3 days per week, simulating the service delivery model of one clinic session per week supported by tablet-based home practice.
RESULTS


Both groups had significantly improved speech outcomes at 4-months post-treatment. Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment. Heterogeneity in response to intervention within the groups suggests that other factors, not measured here, may be having a substantive influence on response to intervention and feedback type.
CONCLUSION


Mobile technology has the potential to increase motivation and engagement with therapy and to mitigate barriers associated with distance and access to speech pathology services. Further research is needed to explore the influence of type and frequency of feedback on motor learning, optimal timing for transitioning from KP to KR feedback, and how these parameters interact with task, child and context-related factors.",2020,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"['childhood apraxia of speech', 'Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS']","['KR vs KP feedback', 'mobile technology equipped with automatic speech recognition (ASR', 'high frequency KR + KP feedback', 'high frequency feedback comprised of both KR and KP']",['speech outcomes'],"[{'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0201653,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'McKechnie', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia; Faculty of Health, University of Canberra, Bruce, ACT, Australia. Electronic address: Jacqui.McKechnie@canberra.edu.au.'}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Ahmed', 'Affiliation': 'Texas A&M University at Qatar, Doha, Qatar; Faculty of Engineering, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gutierrez-Osuna', 'Affiliation': 'Texas A & M University, College Station, TX, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCabe', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Kirrie J', 'Initials': 'KJ', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106026']
1465,32698159,"Effect of conjugated estrogens and bazedoxifene on glucose, energy and lipid metabolism in obese postmenopausal women.","Objective


Combining conjugated estrogens (CE) with the selective estrogen receptor modulator bazedoxifene (BZA) is a novel, orally administered menopausal therapy. We investigated the effect of CE/BZA on insulin sensitivity, energy metabolism, and serum metabolome in postmenopausal women with obesity.
Design


Randomized, double-blind, crossover pilot trial with washout was conducted at Pennington Biomedical Research Center. Eight postmenopausal women (age 50-60 years, BMI 30-40 kg/m2) were randomized to 8 weeks CE/BZA or placebo. Primary outcome was insulin sensitivity (hyperinsulinemic-euglycemic clamp). Secondary outcomes included body composition (DXA); resting metabolic rate (RMR); substrate oxidation (indirect calorimetry); ectopic lipids (1H-MRS); fat cell size, adipose and skeletal muscle gene expression (biopsies); serum inflammatory markers; and serum metabolome (LC/MS).
Results


CE/BZA treatment produced no detectable effect on insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation, but resulted in a non-significant increase in RMR (basal: P = 0.06; high-dose clamp: P = 0.08) compared to placebo. CE/BZA increased serum high-density lipoprotein (HDL)-cholesterol. CE/BZA also increased serum diacylglycerol (DAG) and triacylglycerol (TAG) species containing long-chain saturated, mono- and polyunsaturated fatty acids (FAs) and decreased long-chain acylcarnitines, possibly reflecting increased hepatic de novo FA synthesis and esterification into TAGs for export into very low-density lipoproteins, as well as decreased FA oxidation, respectively (P < 0.05). CE/BZA increased serum phosphatidylcholines, phosphatidylethanolamines, ceramides, and sphingomyelins, possibly reflecting the increase in serum lipoproteins (P < 0.05).
Conclusions


A short treatment of obese postmenopausal women with CE/BZA does not alter insulin action or ectopic fat but increases serum markers of hepatic de novo lipogenesis and TAG production.",2020,"RESULTS


CE/BZA treatment produced no detectable effect on insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation, but resulted in a non-significant increase in RMR (basal: p=0.06; high-dose clamp: p=0.08) compared to placebo.","['obese postmenopausal women', 'postmenopausal women with obesity', 'Eight postmenopausal women (age 50-60 y, BMI 30-40 kg/m2', 'obese postmenopausal women with']","['CE/BZA or placebo', 'conjugated estrogens (CE) with the selective estrogen receptor modulator bazedoxifene (BZA', 'CE/BZA', 'conjugated estrogens and bazedoxifene', 'placebo']","['serum phosphatidylcholines, phosphatidylethanolamines, ceramides, and sphingomyelins, possibly reflecting the increase in serum lipoproteins (p<0.05', 'RMR', 'glucose, energy and lipid metabolism', 'body composition (DXA); resting metabolic rate (RMR); substrate oxidation (indirect calorimetry); ectopic lipids (1H-MRS); fat cell size, adipose and skeletal muscle gene expression (biopsies); serum inflammatory markers; and serum metabolome (LC/MS', 'insulin sensitivity (hyperinsulinemic-euglycemic clamp', 'insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation', 'serum high-density lipoprotein (HDL)-cholesterol', 'insulin sensitivity, energy metabolism, and serum metabolome', 'serum diacylglycerol (DAG) and triacylglycerol']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0732611', 'cui_str': 'Selective estrogen receptor modulator'}, {'cui': 'C2346970', 'cui_str': 'bazedoxifene'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0031618', 'cui_str': 'Phosphatidylethanolamines'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0012262', 'cui_str': 'Diacylglycerols'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.199062,"RESULTS


CE/BZA treatment produced no detectable effect on insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation, but resulted in a non-significant increase in RMR (basal: p=0.06; high-dose clamp: p=0.08) compared to placebo.","[{'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Marlatt', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Lovre', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Chandra R', 'Initials': 'CR', 'LastName': 'Tate', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Evelyn K', 'Initials': 'EK', 'LastName': 'Hayes', 'Affiliation': 'Baton Rouge General Hospital, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Burant', 'Affiliation': 'Departments of Internal Medicine, Molecular and Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Mauvais-Jarvis', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, Louisiana, USA.'}]",European journal of endocrinology,['10.1530/EJE-20-0619']
1466,32698681,Efficacy of laparoscopic gastric bypass  vs  laparoscopic sleeve gastrectomy in treating obesity combined with type-2 diabetes.,"OBJECTIVE


This prospective study compared the efficacy and safety of laparoscopic gastric bypass and laparoscopic sleeve gastrectomy in treating overweight and obese patients with BMI>28 kg/m 2  and type-2 diabetes.
METHODS


Patients were randomized into a gastric bypass group (n = 77) or a gastrectomy group (n = 80). The surgery time, intraoperative blood loss, recovery time, and hospitalization time were collected. BMI, waistline, hipline, C-peptide level, insulin resistance index (HOMA-IR), and their blood and lipid profile were also measured.
RESULTS


Surgery time and blood loss were significantly higher in the gastrectomy group, when compared to the gastric bypass group ( P  < 0.05). In both groups, the levels of BMI, waist circumference and hip circumference (but not their ratio) gradually and significantly decreased after surgery compared with baseline ( P  < 0.05), and no significant difference was found between these two groups. The C-peptide level, HOMA-IR, fasting blood glucose, 2-hour postprandial blood glucose and glycosylated haemoglobin gradually and significantly decreased after surgery compared with the values before treatment ( P  < 0.05). The levels of total cholesterol, triglyceride, LDL, and monocyte chemoattractant protein-1 were also lower after surgery in both groups, while HDL and glucagon-like peptide-1 were significantly higher after surgery compared with the values before treatment ( P  < 0.05). However, no significant difference was found between these two groups of patients.
CONCLUSION


Both laparoscopic gastric bypass and laparoscopic sleeve gastrectomy improved the BMI and diabetic conditions of overweight/obese diabetics, while laparoscopic sleeve gastrectomy had a shorter surgical time and less blood loss.",2020,"Both laparoscopic gastric bypass and laparoscopic sleeve gastrectomy improved the BMI and diabetic conditions of overweight/obese diabetics, while laparoscopic sleeve gastrectomy had a shorter surgical time and less blood loss.","['treating overweight and obese patients with BMI>28 kg/m 2  and type-2 diabetes', 'overweight/obese diabetics', 'Patients were randomized into a gastric bypass group (n=77) or a gastrectomy group (n=80']","['laparoscopic gastric bypass and laparoscopic sleeve gastrectomy', 'laparoscopic gastric bypass  vs  laparoscopic sleeve gastrectomy', 'laparoscopic sleeve gastrectomy']","['levels of total cholesterol, triglyceride, LDL, and monocyte chemoattractant protein-1', 'C-peptide level, HOMA-IR, fasting blood glucose, 2-hour postprandial blood glucose and glycosylated hemoglobin', 'levels of BMI, waist circumference and hip circumference', 'surgery time, intraoperative blood loss, recovery time, and hospitalization time', 'BMI, waistline, hipline, C-peptide level, insulin resistance index (HOMA-IR), and their blood and lipid profile', 'efficacy and safety', 'Surgery time and blood loss', 'BMI and diabetic conditions', 'surgical time and less blood loss', 'HDL and glucagon-like peptide-1']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0129514,"Both laparoscopic gastric bypass and laparoscopic sleeve gastrectomy improved the BMI and diabetic conditions of overweight/obese diabetics, while laparoscopic sleeve gastrectomy had a shorter surgical time and less blood loss.","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Gastrointestinal Surgery, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , JiangSu, China.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Gastrointestinal Surgery, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , JiangSu, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Gastrointestinal Surgery, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , JiangSu, China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Soochow University; the First Affiliated Hospital of Kangda College, Nanjing Medical University , Nanjing, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hui', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, the First People's Hospital of Lianyungang; Lianyungang Clinical College of Nanjing Medical University, the First People's Hospital of Lianyungang , Jiangsu, China.""}]",British journal of biomedical science,['10.1080/09674845.2020.1798578']
1467,32698694,Tailoring Health-promoting Programs for Patients with Chronic Kidney Disease: Randomized Controlled Trial.,"Research on dietary and lifestyle modifications to decrease cardiovascular risk and slow disease progression has been limited to patients in the later stages of chronic kidney disease (CKD). Studies on the effectiveness of stage-of-change-tailored interventions on lifestyle modifications for individuals with early stage CKD are limited. Using random assignment, 60 patients with early stage CKD who received up to six tailored intervention visits over 30 months were compared to 60 usual care patients on physical indicators, lifestyle behaviors, and quality of life. Tailored interventions were consistent with the trans-theoretical Model of Change. Waist circumference, nutrition, and stress management improved over time in the intervention group. There was no difference or change in quality of life. To promote a healthier lifestyle, findings suggest that clinicians working with patients with CKD should consider patients' readiness to change their behaviors as well as implementation strategies tailored for different processes of change.",2020,There was no difference or change in quality of life.,"['patients in the later stages of chronic kidney disease (CKD', '60 patients with early stage CKD who received', 'individuals with early stage CKD', 'Patients with Chronic Kidney Disease']","['Tailoring Health-promoting Programs', 'up to six tailored intervention visits']","['Waist circumference, nutrition, and stress management', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0266218,There was no difference or change in quality of life.,"[{'ForeName': 'Hsiu-Lan', 'Initials': 'HL', 'LastName': 'Teng', 'Affiliation': 'Department of Nursing, Foo-Yin University, Kaohsiung City, Taiwan.'}, {'ForeName': 'Miaofen', 'Initials': 'M', 'LastName': 'Yen', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Fetzer', 'Affiliation': 'Department of Nursing, College of Health and Human Services, University of New Hampshire, Durham, NH, USA.'}, {'ForeName': 'Junne-Ming', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Research Institute of Clinical Medicine, School of Medicine, National Cheng Kung University/Renal Division, National Cheng Kung University Hospital, Tainan City, Taiwan.'}, {'ForeName': 'Shih-Yuan', 'Initials': 'SY', 'LastName': 'Hung', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, E-DA Hospital / Department of Health Management, I-Shou University, Kaohsiung City, Taiwan.'}]",Western journal of nursing research,['10.1177/0193945920942487']
1468,32700188,"Long-Term Cost-Effectiveness Analyses of Empagliflozin Versus Oral Semaglutide, in Addition to Metformin, for the Treatment of Type 2 Diabetes in the UK.","INTRODUCTION


International guidelines recommend treatment with a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist for treatment intensification in type 2 diabetes mellitus (T2DM) patients with progression on metformin. In the randomised, controlled, Peptide Innovation for Early Diabetes Treatment (PIONEER) 2 trial, the SGLT-2 inhibitor empagliflozin was compared with the GLP-1 receptor agonist oral semaglutide, in addition to metformin. The aim of the current study was to assess the long-term cost-effectiveness of empagliflozin 25 mg versus oral semaglutide 14 mg, in addition to metformin, for T2DM patients in the UK.
METHODS


Analyses were conducted from the UK healthcare payer perspective, using the IQVIA Core Diabetes model, with a time horizon of 50 years. Patients received either empagliflozin or oral semaglutide, in addition to metformin, until Hba1c threshold of 7.5% (58 mmol/mol) was exceeded, following which treatment intensification with insulin glargine in addition to empagliflozin or oral semaglutide plus metformin was assumed. Baseline cohort characteristics and 52-week treatment effects were derived from the PIONEER 2 trial. Treatment effects of empagliflozin and GLP-1 receptor agonists on hospitalisation for heart failure (hHF) were based on the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) real-world study. Utilities, treatment costs and costs of diabetes-related complications were obtained from published sources.
RESULTS


Direct costs for empagliflozin plus metformin were considerably lower than those for oral semaglutide plus metformin (by more than GBP 6000). Compared with oral semaglutide plus metformin, empagliflozin plus metformin was a cost-effective treatment for T2DM patients in all scenarios tested. Probabilistic sensitivity analysis showed cost-effectiveness in > 95% of the iterations using a threshold of 20,000 GBP/QALY.
CONCLUSION


Empagliflozin 25 mg is a cost-effective treatment option versus oral semaglutide 14 mg, when used in addition to metformin, for the treatment of T2DM patients in the UK.",2020,"Probabilistic sensitivity analysis showed cost-effectiveness in > 95% of the iterations using a threshold of 20,000 GBP/QALY.
","['type 2 diabetes mellitus (T2DM) patients with progression on', 'T2DM patients in the UK', 'Early Diabetes Treatment (PIONEER', 'Analyses were conducted from the UK healthcare payer perspective, using the IQVIA Core Diabetes model, with a time horizon of 50\xa0years', 'Type 2 Diabetes in the UK']","['oral semaglutide plus metformin, empagliflozin plus metformin', 'Metformin', 'empagliflozin', 'SGLT-2 inhibitor empagliflozin', 'Empagliflozin Versus Oral Semaglutide', 'metformin', 'insulin glargine in addition to empagliflozin or oral semaglutide plus metformin', 'empagliflozin and GLP-1 receptor agonists', 'Empagliflozin', 'oral semaglutide plus metformin', 'empagliflozin plus metformin', 'sodium-glucose cotransporter-2\xa0(SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist', 'empagliflozin or oral semaglutide, in addition to metformin']","['cost-effectiveness', 'hospitalisation for heart failure (hHF', 'Utilities, treatment costs and costs of diabetes-related complications']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2348942', 'cui_str': 'Healthcare payer'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}]",,0.0229317,"Probabilistic sensitivity analysis showed cost-effectiveness in > 95% of the iterations using a threshold of 20,000 GBP/QALY.
","[{'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'Global HEOR/Real World Solutions, IQVIA, 2740-266, Porto Salvo, Portugal.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Cummings', 'Affiliation': 'Academic Department of Diabetes and Endocrinology, Queen Alexandra Hospital, Portsmouth, PO6 3LY, Hampshire, UK.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ustyugova', 'Affiliation': 'Boehringer Ingelheim International GmbH, 55216, Ingelheim Am Rhein, Germany.'}, {'ForeName': 'Syed I', 'Initials': 'SI', 'LastName': 'Raza', 'Affiliation': 'Boehringer Ingelheim Ltd., Bracknell, RG12 8YS, Berkshire, UK.'}, {'ForeName': 'Shamika U', 'Initials': 'SU', 'LastName': 'de Silva', 'Affiliation': 'Boehringer Ingelheim Ltd., Bracknell, RG12 8YS, Berkshire, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lamotte', 'Affiliation': 'Global HEOR/Real World Solutions, IQVIA, 1930, Zaventem, Belgium. Mark.lamotte@iqvia.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00883-1']
1469,32701188,"Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer.","BACKGROUND


Tegoprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders.
AIMS


To assess whether tegoprazan is non-inferior to lansoprazole in terms of efficacy and safety in patients with gastric ulcers.
METHODS


In this phase 3, double-blind, active control, multicentre study, 306 gastric ulcer patients were randomised to one of three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg once daily for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed ulcers confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms and safety were assessed.
RESULTS


In the full analysis set, the cumulative healing rates at week 8 were 94.8% (91/96) for the tegoprazan 50 mg, 95.0% (94/99) for the tegoprazan 100 mg and 95.7% (89/93) for the lansoprazole 30 mg groups. At week 4, the respective healing rates were 90.6% (87/96), 91.9% (91/99), and 89.2% (83/93). In per protocol analysis, 4-week healing rates were 95.4% (84/88), 94.6% (88/93) and 92.9% (79/85) for tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg, respectively. Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks. The incidence of drug-related treatment-emergent adverse events did not differ among groups. The increase in serum gastrin concentration was not higher in tegoprazan-treated patients than in lansoprazole-treated patients.
CONCLUSIONS


Tegoprazan 50 or 100 mg were not inferior to lansoprazole 30 mg once daily in the treatment of gastric ulcers.",2020,Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks.,"['306 gastric ulcer patients', 'patients with gastric ulcers', 'gastric ulcer']","['tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole', 'lansoprazole', 'Tegoprazan', 'tegoprazan', 'tegoprazan 50\xa0mg, tegoprazan 100\xa0mg and lansoprazole']","['ulcer healing', 'cumulative healing rates', 'cumulative percentages of patients with healed ulcers', 'respective healing rates', 'Symptoms and safety', 'efficacy and safety', '4-week healing rates', 'incidence of drug-related treatment-emergent adverse events', 'serum gastrin concentration']","[{'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",306.0,0.118333,Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks.,"[{'ForeName': 'Yu Kyung', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Myung-Gyu', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Suck Chei', 'Initials': 'SC', 'LastName': 'Choi', 'Affiliation': 'Iksan, Korea.'}, {'ForeName': 'Kee Myung', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Suwon, Korea.'}, {'ForeName': 'Tae Oh', 'Initials': 'TO', 'LastName': 'Kim', 'Affiliation': 'Busan, Korea.'}, {'ForeName': 'Soo-Heon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Jeong Seop', 'Initials': 'JS', 'LastName': 'Moon', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': 'Goyang, Korea.'}, {'ForeName': 'Dae Hwan', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Yangsan, Korea.'}, {'ForeName': 'Gab Jin', 'Initials': 'GJ', 'LastName': 'Cheon', 'Affiliation': 'Gangneung, Korea.'}, {'ForeName': 'Gwang Ho', 'Initials': 'GH', 'LastName': 'Baik', 'Affiliation': 'Chuncheon, Korea.'}, {'ForeName': 'Kyoung Oh', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Incheon, Korea.'}, {'ForeName': 'Kwang Bum', 'Initials': 'KB', 'LastName': 'Cho', 'Affiliation': 'Daegu, Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Busan, Korea.'}, {'ForeName': 'Jong-Jae', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Byoung Kwan', 'Initials': 'BK', 'LastName': 'Son', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Hye-Kyung', 'Initials': 'HK', 'LastName': 'Jung', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Byung-Wook', 'Initials': 'BW', 'LastName': 'Kim', 'Affiliation': 'Incheon, Korea.'}, {'ForeName': 'Sung Kuk', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Daegu, Korea.'}, {'ForeName': 'Soo Teik', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Jeonju, Korea.'}, {'ForeName': 'Jae Myung', 'Initials': 'JM', 'LastName': 'Cha', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Ah Rong', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Hyun Wook', 'Initials': 'HW', 'LastName': 'Park', 'Affiliation': 'Seoul, Korea.'}, {'ForeName': 'Geun Seog', 'Initials': 'GS', 'LastName': 'Song', 'Affiliation': 'Seoul, Korea.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15865']
1470,32700489,[Experimental study of individualized 3D printing-guided template combined with thoracolumbar pedicle screw placement for the treatment of ankylosing spondylitis].,"OBJECTIVE


To evaluate accuracy and safety of individualized 3D printing guided template for thoracolumbar pedicle screw placement in patients with ankylosing spondylitis.
METHODS


From January 2016 to September 2019, thoracolumbar spine three-dimensional CT data of 8 patients with ankylosing spondylitis were included, Mimics 17.0 and ideaMaker computer software were applied to design thoracolumbar pedicle screw guided template of patients with AS, physical model of all patients (T 10 -L 2 )were printed by 3D printer, 2 parts in each patient, and divided into guide-plate-assisted screw group (experimental group) and free-hand nail group (control group). Thoracolumbar pedicle screws of both groups were placed by the same spinal surgeon. The accuracy of pedicle screw placement between two groups were evaluated according to results of postoperative CT, the accuracy of the fixation of thoracolumbar pedicle screw was divided into 4 grades, grade 0 and 1 screws were acceptable nails, grade 2 and 3 screws were unacceptable nails. The diameter and length of pedicle screws, the distance between entry point and posterior median line designed by preoperative 3D printing were compared with actual use in operation.
RESULTS


Twenty three blocks of thoracolumbar 3D printing screw of ankylosing spondylitis guided templates were designed and printed in guide-plate-assisted screw group, 46 screws were inserted and 44 screws were accepted. The time of implanting a screw into thoracolumbar pedicle was (4.20±1.15) min, the frequency of X-ray was (5.00±1.25) times and the average adjustment times of screw and Kirschner needle during screw placement was (1.76±1.32) times. In the control group, 46 nails were placed by traditional surgical method and 30 screws were accepted. The time of implanting a screw into thoracolumbar pedicle was (14.67±2.23) min, the frequency of X-ray fluoroscopy was (14.46±2.21) times and the average times of Kirschner needle adjustment was (4.76±3.39) times. The success rates between experimental group and control group were 95.65%(44 / 46) and 56.22%(30 / 46) respectively, and had statistical difference (χ 2 =13.538,  P <0.05). There was no significant difference in diameter, length of pedicle screws and the distance of posterior median line between virtual designed by 3D printing before operation and actual situation in opertaion ( P >0.05). The operation time of inserting a single screw, the times of X-ray fluoroscopy, and the average times of adjustment screw and Kirschner needle in experimental group were significant less than those in control group( P <0.01).
CONCLUSION


The personalized guide template assisted the thoracolumbar fixation designed by 3D printing could significantly improve safety, accuracy and efficiency of surgery, especially suitable for thoracolumbar vertebral bodies requiring posterior pedicle screw fixation for fracture or dislocation with AS.",2020,"There was no significant difference in diameter, length of pedicle screws and the distance of posterior median line between virtual designed by 3D printing before operation and actual situation in opertaion ( P >0.05).","['patients with ankylosing spondylitis', 'From January 2016 to September 2019, thoracolumbar spine three-dimensional CT data of 8 patients with ankylosing spondylitis', 'ankylosing spondylitis', 'Twenty']","['thoracolumbar pedicle screw placement', 'individualized 3D printing guided template', 'thoracolumbar', 'thoracolumbar pedicle screw guided template', 'individualized 3D printing-guided template combined with thoracolumbar pedicle screw placement', 'guide-plate-assisted screw group (experimental group) and free-hand nail group (control group']","['time of implanting a screw into thoracolumbar pedicle', 'Thoracolumbar pedicle screws', 'accuracy of pedicle screw placement', 'diameter, length of pedicle screws and the distance of posterior median line between virtual designed by 3D printing before operation and actual situation in opertaion', 'safety, accuracy and efficiency of surgery', 'success rates', 'operation time of inserting a single screw', 'average times of adjustment screw and Kirschner needle', 'diameter and length of pedicle screws, the distance between entry point and posterior median line designed by preoperative 3D printing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}]","[{'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}]",8.0,0.0132114,"There was no significant difference in diameter, length of pedicle screws and the distance of posterior median line between virtual designed by 3D printing before operation and actual situation in opertaion ( P >0.05).","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233000, Anhui, China.'}, {'ForeName': 'Guo-Qi', 'Initials': 'GQ', 'LastName': 'Niu', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233000, Anhui, China.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233000, Anhui, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233000, Anhui, China.'}, {'ForeName': 'Lu-Tan', 'Initials': 'LT', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233000, Anhui, China.'}, {'ForeName': 'Qian-Kun', 'Initials': 'QK', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233000, Anhui, China.'}, {'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233000, Anhui, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.07.011']
1471,32700492,[Back arm flexion and extension combined with manipulation for the treatment of patient with adhesive scapulohumeral periarthritis].,"OBJECTIVE


To observe clinical efficacy of back arm flexion and extension combined with manipulation in treating adhesive scapulohumeral periarthritis.
METHODS


From March 2016 to April 2018, 53 patients with adhesive scapulohumeral periarthritis were treated with back arm flexion and extension combined with manipulation, the main symptoms were shoulder pain and limited activity. There were 22 males and 31 females aged from 45 to 71 years old with an average of (51.63±5.79) years;the courses of disease ranged from 3 to 24 months with an average of (8.62±3.73) months. Manipulation treatment was carried out once a week, and back arm flexion and extension were performed for 3 times a day with15 movements each time, totally 4 weeks for a single course. Visual analogue scale (VAS) and Constant-Murley shoulder function score were observed and compared before treatment and one week, one and three months after treatment.
RESULTS


All patients were followed up from 3 to 12 months, with an average of (5.91±3.55) months. VAS score before treatment was 4.02±1.46, and was improved to 3.15±1.54, 1.98±1.37, 1.12±0.86 respectively at one week, one and three months after treatment. Constant-Murley score before treatment was 42.70 ±5.72, and improved to 54.25 ±6.34, 67.45 ±6.84, 82.40 ±6.63 at one week, one and three months after treatment respectively;19 patients got excellent result, 22 good, 9 fair and 3 poor.
CONCLUSION


Back arm flexion combined with manipulation for the treatment of adhesive scapulohumeral periarthritis could effectively relieve pain, improve shoulder function, which is a simple effective treatment strategy.",2020,"CONCLUSION


Back arm flexion combined with manipulation for the treatment of adhesive scapulohumeral periarthritis could effectively relieve pain, improve shoulder function, which is a simple effective treatment strategy.","['22 males and 31 females aged from 45 to 71 years old with an average of (51.63±5.79) years;the courses of disease ranged from 3 to 24 months with an average of (8.62±3.73) months', 'patient with adhesive scapulohumeral periarthritis', 'From March 2016 to April 2018, 53 patients with adhesive scapulohumeral periarthritis']","['back arm flexion and extension combined with manipulation', 'Back arm flexion and extension combined with manipulation']","['Constant-Murley score', 'Visual analogue scale (VAS) and Constant-Murley shoulder function score', 'VAS score']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0031037', 'cui_str': 'Periarthritis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",53.0,0.0277231,"CONCLUSION


Back arm flexion combined with manipulation for the treatment of adhesive scapulohumeral periarthritis could effectively relieve pain, improve shoulder function, which is a simple effective treatment strategy.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Hong-Sheng', 'Initials': 'HS', 'LastName': 'Zhan', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Qing-Lai', 'Initials': 'QL', 'LastName': 'Wang', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Hui-Ming', 'Initials': 'HM', 'LastName': 'Wu', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Jiang-Tao', 'Initials': 'JT', 'LastName': 'Zhou', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.07.014']
1472,32703808,"When possible, report a Fisher-exact  P  value and display its underlying null randomization distribution.","In randomized experiments, Fisher-exact  P  values are available and should be used to help evaluate results rather than the more commonly reported asymptotic  P  values. One reason is that using the latter can effectively alter the question being addressed by including irrelevant distributional assumptions. The Fisherian statistical framework, proposed in 1925, calculates a  P  value in a randomized experiment by using the actual randomization procedure that led to the observed data. Here, we illustrate this Fisherian framework in a crossover randomized experiment. First, we consider the first period of the experiment and analyze its data as a completely randomized experiment, ignoring the second period; then, we consider both periods. For each analysis, we focus on 10 outcomes that illustrate important differences between the asymptotic and Fisher tests for the null hypothesis of no ozone effect. For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value. For the other outcomes, the Fisher-exact null randomization distribution substantially differed from the bell-shaped one assumed by the asymptotic  t  test. Our conclusions: When researchers choose to report  P  values in randomized experiments, 1) Fisher-exact  P  values should be used, especially in studies with small sample sizes, and 2) the shape of the actual null randomization distribution should be examined for the recondite scientific insights it may reveal.",2020,"For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value.",[],[],[],[],[],[],,0.0315853,"For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value.","[{'ForeName': 'M-A C', 'Initials': 'MC', 'LastName': 'Bind', 'Affiliation': 'Department of Statistics, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138; ma.bind@mail.harvard.edu.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Rubin', 'Affiliation': 'Yau Center for Mathematical Sciences, Tsinghua University, Beijing 100084, China.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1915454117']
1473,32708860,We Don't Talk about It: Cancer Pain and American Indian Survivors.,"Pain is a common symptom among cancer survivors, yet is rarely talked about by American Indians. Understanding the reasons for reduced communication by American Indian cancer survivors is important for healthcare providers, family members, and others providing treatment and support for cancer symptoms. Thirteen focus groups with Southwest American Indian adult cancer survivors were audiotaped and transcribed as part of a randomized intervention to remove barriers to cancer symptom management. Constant comparative methods were employed in the data analysis, topic categories were grouped for comparison, and final assessment followed Grounded Theory methods. Findings were categorized into two major groupings: communication with family members and communication with health care providers. Within these two groupings, three themes emerged to describe cancer pain experiences and communication barriers: (1) We don't talk about it, (2) Respect for healthcare providers; and (3) Culturally prohibitive topics on death and pain experiences. Not talking about their cancer diagnosis and cancer-related pain leaves many American Indian cancer survivors without much-needed social support, contributing to reduced treatment compliance and access to healthcare. Findings have implications for educational interventions and quality of life improvement for American Indian and other underrepresented communities.",2020,"Not talking about their cancer diagnosis and cancer-related pain leaves many American Indian cancer survivors without much-needed social support, contributing to reduced treatment compliance and access to healthcare.","['Thirteen focus groups with Southwest American Indian adult cancer survivors', 'American Indian and other underrepresented communities', 'American Indian cancer survivors']",[],['death and pain experiences'],"[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0190248,"Not talking about their cancer diagnosis and cancer-related pain leaves many American Indian cancer survivors without much-needed social support, contributing to reduced treatment compliance and access to healthcare.","[{'ForeName': 'Felicia Schanche', 'Initials': 'FS', 'LastName': 'Hodge', 'Affiliation': 'School of Nursing, University of California, 700 Tiverton Avenue, Room 5-934A Factor Building, Los Angeles, CA 90095-1702, USA.'}, {'ForeName': 'Tracy Line', 'Initials': 'TL', 'LastName': 'Itty', 'Affiliation': 'School of Nursing, University of California, 700 Tiverton Avenue, Room 5-934A Factor Building, Los Angeles, CA 90095-1702, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Samuel-Nakamura', 'Affiliation': 'School of Nursing, University of California, 700 Tiverton Avenue, Room 5-934A Factor Building, Los Angeles, CA 90095-1702, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cadogan', 'Affiliation': 'School of Nursing, University of California, 700 Tiverton Avenue, Room 5-934A Factor Building, Los Angeles, CA 90095-1702, USA.'}]",Cancers,['10.3390/cancers12071932']
1474,32706660,Combination of 3-Dimensional Virtual Reality and Hands-On Aromatherapy in Improving Institutionalized Older Adults' Psychological Health: Quasi-Experimental Study.,"BACKGROUND


In Taiwan, which has one of the most rapidly aging populations in the world, it is becoming increasingly critical to promote successful aging strategies that are effective, easily usable, and acceptable to institutionalized older adults. Although many practitioners and professionals have explored aromatherapy and identified its psychological benefits, the effectiveness of combining 3-dimensional (3D) virtual reality and hands-on aromatherapy remains unknown.
OBJECTIVE


A quasi-experimental trial was designed to evaluate the effectiveness of this combination in lowering perceived stress and promoting happiness, sleep quality, meditation experience, and life satisfaction among institutionalized older adults in Taiwan.
METHODS


A total of 60 institutionalized elderly participants either received the combined intervention or were in a control group. Weekly 2-hour sessions were implemented over 9 weeks. The outcome variables were happiness, perceived stress, sleep quality, meditation experience, and life satisfaction, which were assessed at baseline and after the intervention.
RESULTS


Generalized estimating equation (GEE) analyses indicated that the experimental group showed significant post-intervention improvements in terms of scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction (n=48; all P<.001). Another GEE analysis showed that the significant improvements in the 5 outcome variables persisted in participants aged 80 years and older (n=35; all P<.001).
CONCLUSIONS


This is the first trial to explore the effectiveness of a combination of 3D virtual reality and hands-on aromatherapy in improving older adults' psychological health. The results are promising for the promotion of psychological health in institutionalized older adults.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04324216; https://clinicaltrials.gov/ct2/show/NCT04324216.",2020,"RESULTS


Generalized estimating equation (GEE) analyses indicated that the experimental group showed significant post-intervention improvements in terms of scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction (n=48; all P<.001).","['institutionalized older adults in Taiwan', '60 institutionalized elderly participants', ""older adults' psychological health"", 'participants aged 80 years and older (n=35; all P<.001', 'institutionalized older adults', ""Institutionalized Older Adults' Psychological Health""]","['3-Dimensional Virtual Reality and Hands', 'Aromatherapy', '3D virtual reality and hands-on aromatherapy', 'combined intervention']","['scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction', 'lowering perceived stress and promoting happiness, sleep quality, meditation experience, and life satisfaction', 'happiness, perceived stress, sleep quality, meditation experience, and life satisfaction']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",60.0,0.0374316,"RESULTS


Generalized estimating equation (GEE) analyses indicated that the experimental group showed significant post-intervention improvements in terms of scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction (n=48; all P<.001).","[{'ForeName': 'Vivian Ya-Wen', 'Initials': 'VY', 'LastName': 'Cheng', 'Affiliation': 'PureAroma Healing Academy, Taipei, Taiwan.'}, {'ForeName': 'Chiu-Mieh', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jung-Yu', 'Initials': 'JY', 'LastName': 'Liao', 'Affiliation': 'Institute of Population Health sciences, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Hsiao-Pei', 'Initials': 'HP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Wen', 'Initials': 'SW', 'LastName': 'Wang', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Su-Fei', 'Initials': 'SF', 'LastName': 'Huang', 'Affiliation': 'Department of Senior Citizen Service, Mackay Junior College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jong-Long', 'Initials': 'JL', 'LastName': 'Guo', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Journal of medical Internet research,['10.2196/17096']
1475,32706734,Acceptability of an Embodied Conversational Agent for Type 2 Diabetes Self-Management Education and Support via a Smartphone App: Mixed Methods Study.,"BACKGROUND


Embodied conversational agents (ECAs) are increasingly used in health care apps; however, their acceptability in type 2 diabetes (T2D) self-management apps has not yet been investigated.
OBJECTIVE


This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
METHODS


A sequential mixed methods design was applied. Adults with T2D allocated to the intervention arm of the MDC trial used the MDC app over a period of 12 months. At 6 months, they completed questions assessing their interaction with, and attitudes toward, the ECA. In-depth qualitative interviews were conducted with a subsample of the participants from the intervention arm to explore their experiences of using the ECA. The interview questions included the participants' perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character. The quantitative and qualitative data were interpreted using integrated synthesis.
RESULTS


Of the 93 intervention participants, 44 (47%) were women; the mean (SD) age of the participants was 55 (SD 10) years and the baseline glycated hemoglobin A1c level was 7.3% (SD 1.5%). Overall, 66 of the 93 participants (71%) provided survey responses. Of these, most described Laura as being helpful (57/66, 86%), friendly (57/66, 86%), competent (56/66, 85%), trustworthy (48/66, 73%), and likable (40/66, 61%). Some described Laura as not real (18/66, 27%), boring (26/66, 39%), and annoying (20/66, 30%). Participants reported that interacting with Laura made them feel more motivated (29/66, 44%), comfortable (24/66, 36%), confident (14/66, 21%), happy (11/66, 17%), and hopeful (8/66, 12%). Furthermore, 20% (13/66) of the participants were frustrated by their interaction with Laura, and 17% (11/66) of the participants reported that interacting with Laura made them feel guilty. A total of 4 themes emerged from the qualitative data (N=19): (1) perceived role: a friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura's words and actions.
CONCLUSIONS


These findings suggest that an ECA is an acceptable means to deliver T2D self-management education and support. A human-like character providing ongoing, friendly, nonjudgmental, emotional, and motivational support is well received. Nevertheless, the ECA can be improved by increasing congruence between its verbal and nonverbal communication and accommodating user preferences.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry CTRN12614001229662; https://tinyurl.com/yxshn6pd.",2020,"This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
","['Adults with T2D', ""participants' perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character""]","['Embodied Conversational Agent', 'Embodied conversational agents (ECAs', 'ECA (Laura', ""friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura's words and actions"", 'ECA']","['survey responses', 'baseline glycated hemoglobin A1c level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007952', 'cui_str': 'Character'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}]",93.0,0.0433844,"This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
","[{'ForeName': 'Shaira', 'Initials': 'S', 'LastName': 'Baptista', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Wadley', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bird', 'Affiliation': 'The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""see Authors' Contributions, .""}]",JMIR mHealth and uHealth,['10.2196/17038']
1476,32714001,Evaluation of a Novel Trocar-Site Closure Device in Laparoscopic Surgery.,"Background and Objectives


We evaluated the effectiveness and safety of EZ-Close TM  compared to those of hand suture for trocar-site closure according to obesity.
Methods


Fifty-four cases of laparoscopic colorectal surgery were enrolled. For the same patient, the right port site was closed using EZ-Close TM  and left port site was closed by hand suture among cases with port-site diameter ≥10 mm. Cases switched to use of a conventional fascial closure device or with closure time 120 s were considered failures. Closure time was analyzed according to body mass index (BMI) and abdominal wall thickness (AWT).
Results


The mean closure time was significantly shorter with EZ-Close TM  than with hand suture (87.9 ± 21.0 vs. 128.0 ± 59.0 s,  p  < 0.001). The number of failure cases was significantly lower with EZ-Close TM  than with hand suture (7 vs. 27,  p  < 0.001). The closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with BMI ≥ 25 and < 27 kg/m 2  (n = 15, 85.9 ± 19.8 vs. 135.6 ± 67.9 s,  p  < 0.014) and ≥ 27 kg/m 2  (n = 13, 85.1 ± 18.4 vs. 150.2 ± 70.6 s,  p  < 0.010). With respect to AWT, the closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with AWT ≥ 20 and < 26 mm (n = 12, 81.1 ± 11.5 vs. 142.3 ± 83.7 s,  p  = 0.023) and ≥ 26 mm (n = 17, 85.6 ± 22.6 vs. 160.2 ± 55.5,  p  < 0.001). No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
Conclusion


EZ-Close TM  could provide time efficiency in trocar-site closure, especially in obese patients.",2020,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","['obese patients', 'Methods\n\n\nFifty-four cases of laparoscopic colorectal surgery were enrolled', 'Laparoscopic Surgery']","['Novel Trocar-Site Closure Device', 'conventional fascial closure device', 'EZ-Close TM']","['number of failure cases', 'mean closure time', 'closure time of EZ-Close TM', 'No infection and herniation', 'Closure time', 'body mass index (BMI) and abdominal wall thickness (AWT']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C2712105', 'cui_str': 'Absence of signs and symptoms of infection'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0446081,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","[{'ForeName': 'Youngbae', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Soohwa', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kyoung-Won', 'Initials': 'KW', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dong-Hyuk', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Jeong-Heum', 'Initials': 'JH', 'LastName': 'Baek', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00033']
1477,32717350,A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction.,"College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive intervention (API) to reduce high-risk drinking among first-year college students. The API is designed to educate students and to motivate heavy-drinking college students to engage in existing resources to support reducing high-risk alcohol use, by leveraging technology-based intervention modalities. The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization. Adaptive preventive interventions have the potential to reduce the acute and long-term negative health consequences of young adult alcohol use.",2020,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","['college student drinking reduction', 'first-year college students']",['adaptive preventive intervention (API'],"['reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization']","[{'cui': 'C4042862', 'cui_str': 'Alcohol Drinking, College Students'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",,0.0187936,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Boatman', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Morrell', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Wagner', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Grace R', 'Initials': 'GR', 'LastName': 'Lyden', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, 2800 Plymouth Road, NCRC Building 10, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Vock', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106089']
1478,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
1479,32717684,"Switching to fingolimod in PREFERMS: Effect of treatment history and naïvety on clinical, MRI and treatment satisfaction outcomes ✰ .","BACKGROUND


Injectable disease-modifying therapies (iDMTs) are often used as first-line treatments for relapsing multiple sclerosis. Fingolimod is frequently used following treatment with iDMTs. Whether prior iDMT treatment impacts the effectiveness of subsequent fingolimod therapy is unclear. Here, we assessed switching from iDMTs to fingolimod, and the impact of treatment history on fingolimod escalation using data from the 12-month 'Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention on Fingolimod versus approved first-line disease-modifying thErapies in adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS). The study design and results at the end of randomized treatment (EoRT) in PREFERMS have been published.
METHODS


Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study. Pre-specified exploratory analyses compared outcomes in those randomized to fingolimod or to an iDMT at end of study (EoS), which included time spent on randomized and on switch treatment. Post hoc exploratory analyses (unadjusted for multiplicity owing to the large number of comparisons) among patients randomized to an iDMT who switched to fingolimod, compared outcomes longitudinally before (EoRT) and after (EoS) switching, and compared outcomes at EoRT and EoS among subgroups stratified by iDMT-treatment history. Outcomes included brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates.
RESULTS


At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to fingolimod had switched to an iDMT. By EoS, 44.2% of total treatment exposure in the iDMT group was to fingolimod and the mean time spent on fingolimod in this group was 220 days (approximately 7 months). Outcomes in the fingolimod group at EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score) were similar to those seen at EoRT, but in the iDMT group these outcomes were more favorable at EoS than at EoRT and were similar to rates seen in the fingolimod group. Among patients who switched from iDMT to fingolimod, there were longitudinal improvements in ARR (EoRT, 0.3 [95% confidence interval (CI), 0.2-0.4]; EoS, 0.2 [0.1-0.3]; odds ratio, 0.5 [0.3-0.9]) and in treatment satisfaction (proportion of patients with MSQ > 5; EoRT, 67.4%; EoS, 90.4%; odds ratio, 5.7 [95% CI, 3.4-9.4]) after fingolimod treatment, and changes in brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation were also more favorable at EoS than at EoRT. In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
CONCLUSION


These analyses indicate that patients in PREFERMS had improved outcomes within months of switching to fingolimod from an iDMT and that improvements occurred irrespective of the number of iDMTs previously administered. These data provide a unique opportunity to explore clinical, radiological and safety outcomes associated with a range of clinically relevant treatment pathways.",2020,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","['At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to', 'Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study', ""adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS""]","['fingolimod had switched to an iDMT', 'Fingolimod versus approved first-line disease-modifying thErapies']","['EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score', 'mean time spent on fingolimod', 'brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates', 'longitudinal improvements in ARR', 'brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation']","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",439.0,0.0609136,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, 101 Forrest Crossing Blvd. Suite 103, Franklin, TN 37064, United States. Electronic address: sfhunter@neurosci.us.'}, {'ForeName': 'Florian P', 'Initials': 'FP', 'LastName': 'Thomas', 'Affiliation': 'Hackensack Meridian School of Medicine at Seton Hall University, South Orange, and Hackensack University Medical Center, Hackensack, NJ, United States. Electronic address: florian.thomas@hackensackmeridian.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cascione', 'Affiliation': 'Tampa Neurology Associates, Tampa, FL, United States. Electronic address: me@markcascione.com.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Williams', 'Affiliation': 'Oxford PharmaGenesis, Oxford, United Kingdom. Electronic address: ian.williams@pharmagenesis.com.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: xiangyi.meng@novartis.com.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: lesley.schofield@novartis.com.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Weiss', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: jamie.weiss@novartis.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: nadia.tenebaum@novartis.com.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, United States. Electronic address: bruce.cree@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102346']
1480,32720131,Focused Training of Community Health Volunteers on Cervical Cancer in Rural Kisumu.,"The cancer disease burden is higher in the low- and middle-income countries like Kenya where uptake of screening services is low. Community health volunteers (CHVs) have been shown to be effective in improving uptake of health services and could also be used in cervical cancer screening. However, they still have inadequate knowledge hindering effective public education. The aim of this study is to determine the effect of focused training of the CHVs on their knowledge on cervical cancer and screening uptake among women of reproductive age. This was a quasi-experimental study in rural sub-counties of Nyando and Nyakach. Nyando was the intervention arm with 186 CHVs and Nyakach the control with 239 CHVs. Participants' knowledge on cervical cancer was assessed using a self-administered questionnaire. CHVs in the intervention arm were trained about cervical cancer and screening. Knowledge was re-assessed following a 6-month public education period. The focused training improved the CHVs' knowledge on cervical cancer to 60.9% compared to 13.4% in the control arm (p = 0.004) at the end-line. The knowledge was dependent on the level of education (χ 2  = 34.41, p = 0.045), religion (χ 2  = 25.85, p = 0.007), and occupation (χ 2  = 95.04, p < 0.0001). Screening uptake was significantly associated with knowledge of risk factors (p = 0.019) and sign and symptoms (p = 0.017). Screening uptake improved in the intervention arm while declined in the control arm. The training significantly improved the CHVs' knowledge on cervical cancer and uptake of screening services in the intervention area, Kisumu County, Kenya, and should be continuous.",2020,"The training significantly improved the CHVs' knowledge on cervical cancer and uptake of screening services in the intervention area, Kisumu County, Kenya, and should be continuous.","['Community Health Volunteers on Cervical Cancer in Rural Kisumu', 'rural sub-counties of Nyando and Nyakach', 'women of reproductive age', 'Community health volunteers (CHVs']",['CHVs'],"[""CHVs' knowledge on cervical cancer"", 'cervical cancer', 'Screening uptake', 'knowledge of risk factors', ""CHVs' knowledge on cervical cancer and uptake of screening services""]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0225371,"The training significantly improved the CHVs' knowledge on cervical cancer and uptake of screening services in the intervention area, Kisumu County, Kenya, and should be continuous.","[{'ForeName': 'Edwin Onyango', 'Initials': 'EO', 'LastName': 'Ochomo', 'Affiliation': 'AMPATH Cervical Cancer Program, P.O. Box 4606, Eldoret, Kenya. edochomo@gmail.com.'}, {'ForeName': 'Samson', 'Initials': 'S', 'LastName': 'Ndege', 'Affiliation': 'AMPATH Cervical Cancer Program, P.O. Box 4606, Eldoret, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Itsura', 'Affiliation': 'AMPATH Cervical Cancer Program, P.O. Box 4606, Eldoret, Kenya.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01839-6']
1481,32724929,Effect of Different Kinds of Music on Anxiety During Implant Surgery in Turkey: Randomized Controlled Study.,"PURPOSE


Dental anxiety causes patients to avoid or delay dental treatments. This delay leads to more serious dental problems, which can then lead to more invasive and expensive treatment with possible emergency situations. The purpose of this study was to determine the most successful and effective kind of music to lessen the anxiety of patients during dental implant surgery.
MATERIALS AND METHODS


This study was a prospective observational randomized controlled study. Eighty dental implant surgery patients aged between 40 and 70 years were chosen for the study. Patients were divided into four groups: group 1-classic Turkish music group (Saba or Rast Tune); group 2-classical music (Vivaldi); group 3-slow rock music; and group 4-control group. Blood pressures, heart rate, and O 2  saturations of the patients were evaluated along with Corah's Dental Anxiety Survey (CDAS) at admittance. After 5 minutes of music in the room, the same evaluations were recorded, and the survey was repeated.
RESULTS


All the groups with music treatment had a significant decrease in anxiety levels. It was observed that listening to music had a positive effect on dental anxiety regardless of the kind of music. There were significant differences in CDAS values postoperatively. Turkish music and classical music were much more effective in diminishing dental anxiety compared with soft rock music (P = .000 and .002, respectively).
CONCLUSION


This study indicated that regardless of the kind of music, listening to music diminishes dental anxiety significantly; Turkish music and classical music were the most effective kinds of music.",2020,"Turkish music and classical music were much more effective in diminishing dental anxiety compared with soft rock music (P = .000 and .002, respectively).
","['Eighty dental implant surgery patients aged between 40 and 70 years were chosen for the study', 'patients during dental implant surgery', 'Turkey', 'Dental anxiety causes patients to avoid or delay dental treatments']","['1-classic Turkish music group (Saba or Rast Tune); group 2-classical music (Vivaldi); group 3-slow rock music; and group 4-control group', 'Different Kinds of Music']","['Anxiety', 'dental anxiety', 'CDAS values postoperatively', 'anxiety levels', 'Blood pressures, heart rate, and O 2  saturations']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}]","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0034554', 'cui_str': 'Radioallergosorbent test'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0005899', 'cui_str': 'Repetitive rocking movements'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}]",80.0,0.16342,"Turkish music and classical music were much more effective in diminishing dental anxiety compared with soft rock music (P = .000 and .002, respectively).
","[{'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Gulnahar', 'Affiliation': ''}, {'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Kupeli', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.8329']
1482,32725695,Effects of blood flow restriction on muscle size and gene expression in muscle during immobilization: A pilot study.,"PURPOSE


Muscle mass is known to rapidly decrease with muscle disuse. Previous reports suggest that repetitive blood flow restriction (BFR) mitigates the reduction of muscle mass with disuse. However, the effects of BFR on muscle atrophy and gene expression levels in muscle during cast immobilization have not been clarified.
METHODS


To investigate the effect of BFR on muscle atrophy and gene expression levels during cast immobilization in humans, we recruited 10 healthy males who were randomly divided into the control and BFR treatment groups. All subjects were immobilized with a cast for 14 days. BFR treatment was conducted only in the BFR group. We evaluated cross sectional area (CSA) of thigh muscles by magnetic resonance imaging before and 14 days after cast immobilization. A percutaneous biopsy of the vastus lateralis muscle (VL) was performed before and 1, 7, and 14 days after cast immobilization. Expression of genes related to muscle atrophy and synthesis were evaluated using real-time PCR.
RESULTS


The CSA of the VL and the thigh flexor muscles were significantly decreased in both groups; however, percent decrease in CSA was significantly smaller in the BFR group compared with the control group. In two-way repeated ANOVA analysis, the time × treatment interaction in gene expression of the muscle-specific ubiquitin ligases muscle ring finger 1 (MuRF1) was significant, and elevated MURF1 expression level by cast immobilization was seemed to be suppressed by the BFR treatment.
CONCLUSION


BFR treatment may prevent reduced VL and thigh flexor muscles and increased MuRF1 expression level during cast immobilization. Further study is required to confirm these results.",2020,"The CSA of the VL and the thigh flexor muscles were significantly decreased in both groups; however, percent decrease in CSA was significantly smaller in the BFR group compared with the control group.","['humans, we recruited 10 healthy males who were randomly divided into the control and BFR treatment groups', 'muscle during immobilization']","['blood flow restriction', 'BFR', 'repetitive blood flow restriction (BFR']","['reduced VL and thigh flexor muscles and increased MuRF1 expression level', 'muscle size and gene expression', 'CSA of the VL and the thigh flexor muscles', 'elevated MURF1 expression level', 'CSA', 'muscle atrophy and gene expression levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}]",10.0,0.0159256,"The CSA of the VL and the thigh flexor muscles were significantly decreased in both groups; however, percent decrease in CSA was significantly smaller in the BFR group compared with the control group.","[{'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Kakehi', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kubota', 'Affiliation': 'Department of Sports Medicine, Juntendo University Graduate School of Health and Sports Science, Chiba, Japan.'}, {'ForeName': 'Kageumi', 'Initials': 'K', 'LastName': 'Takeno', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keishoku', 'Initials': 'K', 'LastName': 'Sakuraba', 'Affiliation': 'Department of Sports Medicine, Juntendo University Graduate School of Health and Sports Science, Chiba, Japan.'}, {'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Kawamori', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Physiological reports,['10.14814/phy2.14516']
1483,32721549,High intensity interval training combined with L-citrulline supplementation: Effects on physical performance in healthy older adults.,"INTRODUCTION


The aim of this study was to evaluate the effect of citrulline (CIT) supplementation combined to high intensity interval training (HIIT) on physical performance in healthy older adults.
METHODS


This study is a secondary analysis from a double-blind, randomized trial. Among the participants (sedentary & inactive older adults aged over 65 yrs), 44 were non obese (BMI <30 kg/m 2 ) and completed the intervention: Placebo + HIIT (PLA; n = 21) or CIT + HIIT (n = 23). All participants ingested either 10 g of CIT supplementation/day or placebo and followed HIIT sessions (30 min/session; cycle: 30 s > 85% of maximal heart rate (HR) and Borg scale >17/20 + 1:50 min at 65% HR and Borg scale between 13 and 16) on an elliptical device 3 times per week over a 12-week period. Body composition, muscle strength, muscle power, functional capacities (unipodal balance; self-paced and fast Timed Up and Go (nTUG; fTUG); chair test; step tests; 4-meter walking test; 6-minute walking test); dietary intake, energy expenditure and biological markers were measured pre and post-intervention. A repeated-measure analysis of variance was used to estimate time (HIIT intervention), group (PLA vs. CIT) and time*group effects.
RESULTS


The decrease in BMI (p = 0.02) and android fat mass (p = 0.05) were significantly greater in the HIIT+CIT group than in the HIIT+PLA group. Finally, a greater increase in self-paced gait speed (nTUG) (p = 0.02) and fast-paced gait speed (fTUG) (p = 0.03) were also observed in the HIIT+CIT group than in the HIIT+PLA group.
CONCLUSION


CIT supplementation combined to HIIT is more effective in improving functional capacities and body composition in healthy older adults than HIIT alone.",2020,"Finally, a greater increase in self-paced gait speed (nTUG) (p = 0.02) and fast-paced gait speed (fTUG) (p = 0.03) were also observed in the HIIT+CIT group than in the HIIT+PLA group.
","['participants (sedentary & inactive older adults aged over 65\u202fyrs), 44 were non obese (BMI <30\u202fkg/m 2 ) and completed the intervention', 'healthy older adults']","['HIIT+CIT', 'citrulline (CIT) supplementation combined to high intensity interval training (HIIT', 'HIIT+PLA', 'CIT supplementation/day or placebo and followed HIIT sessions', 'CIT supplementation combined to HIIT', 'Placebo + HIIT (PLA; n\u202f=\u202f21) or CIT\u202f+\u202fHIIT', 'High intensity interval training combined with L-citrulline supplementation']","['Body composition, muscle strength, muscle power, functional capacities (unipodal balance; self-paced and fast Timed Up and Go (nTUG; fTUG); chair test; step tests; 4-meter walking test; 6-minute walking test); dietary intake, energy expenditure and biological markers', 'BMI', 'physical performance', 'self-paced gait speed (nTUG', 'fast-paced gait speed (fTUG', 'android fat mass', 'functional capacities and body composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.15454,"Finally, a greater increase in self-paced gait speed (nTUG) (p = 0.02) and fast-paced gait speed (fTUG) (p = 0.03) were also observed in the HIIT+CIT group than in the HIIT+PLA group.
","[{'ForeName': 'Buckinx', 'Initials': 'B', 'LastName': 'F', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, Liège, Belgium.""}, {'ForeName': 'Carvalho', 'Initials': 'C', 'LastName': 'L P', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Marcangeli', 'Initials': 'M', 'LastName': 'V', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Dulac', 'Initials': 'D', 'LastName': 'M', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Hajj Boutros', 'Initials': 'HB', 'LastName': 'G', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Gouspillou', 'Initials': 'G', 'LastName': 'G', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Gaudreau', 'Initials': 'G', 'LastName': 'P', 'Affiliation': ""Département de Médecine, Université de Montréal, Montréal, Canada; Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Noirez', 'Initials': 'N', 'LastName': 'P', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Inserm UMR S-1124 & IRMES EA7329, Université de Paris, Paris, France.""}, {'ForeName': 'Aubertin-Leheudre', 'Initials': 'AL', 'LastName': 'M', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada. Electronic address: aubertin-leheudre.mylene@uqam.ca.""}]",Experimental gerontology,['10.1016/j.exger.2020.111036']
1484,32722634,Effects of an Unstructured Free Play and Mindfulness Intervention on Wellbeing in Kindergarten Students.,"Play is known as the core occupation of young children as it lays a foundation for their early development and physical, emotional and social wellbeing. Literature suggests that unstructured free play and mindfulness interventions may independently promote wellbeing among preschoolers. However, there is no clear evidence of their combination in supporting wellness in early learning environments. We conducted a quasi-experimental study with 42 children aged four to six years, attending two kindergartens in Hong Kong. The intervention included unstructured play with non-directional loose parts (play materials), conducted outdoors for one hour daily followed by a mindfulness intervention for 10 min per day indoors. The intervention lasted for five consecutive days. We examined happiness and aspects of playfulness before and after the intervention, finding a significant increase in all areas. Given greater freedom in play choice, children showed more disruptive behaviors during unstructured play than the control group engaging in recess as usual. We conclude that unstructured play in addition to mindfulness intervention is effective in promoting students' happiness and playfulness, both of which may help maintain mental health and wellbeing amid stressors such as transition and separation. The increased disruptive behavior requires additional investigation.",2020,"Given greater freedom in play choice, children showed more disruptive behaviors during unstructured play than the control group engaging in recess as usual.","['Kindergarten Students', '42 children aged four to six years, attending two kindergartens in Hong Kong']","['Unstructured Free Play and Mindfulness Intervention', 'unstructured play with non-directional loose parts (play materials), conducted outdoors for one hour daily followed by a mindfulness intervention']",['disruptive behaviors'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]",42.0,0.0184046,"Given greater freedom in play choice, children showed more disruptive behaviors during unstructured play than the control group engaging in recess as usual.","[{'ForeName': 'Regina Lai Tong', 'Initials': 'RLT', 'LastName': 'Lee', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health and Medicine, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Shelly Jerrine', 'Initials': 'SJ', 'LastName': 'Lane', 'Affiliation': 'College of Health and Human Sciences, Colorado State University, Fort Collins, CO 80526, USA.'}, {'ForeName': 'Anson Chiu Yan', 'Initials': 'ACY', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, Tung Wah College, Hong Kong, China.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Lobo Hung Tak', 'Initials': 'LHT', 'LastName': 'Louie', 'Affiliation': 'Department of Physical Education, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Browne', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health and Medicine, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Sally Wai Chi', 'Initials': 'SWC', 'LastName': 'Chan', 'Affiliation': 'University of Newcastle Singapore Pte Limited, Singapore 038986, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17155382']
1485,32728832,Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog ®  in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis.,"INTRODUCTION


We evaluated the efficacy and safety of ultra-rapid lispro (URLi) in comparison to lispro in a subgroup analysis of Japanese adults with type 1 diabetes mellitus from the phase 3 PRONTO-T1D trial.
METHODS


After an 8-week lead-in to optimize basal insulin treatment, patients were randomized to 52-week double-blind mealtime URLi or lispro, or 26-week open-label postmeal URLi. The primary endpoint was change in hemoglobin A1c (HbA1c) from baseline (week 0) to week 26 between mealtime URLi and lispro. The multiplicity adjusted objectives were 1- and 2-h postprandial glucose (PPG) excursions after a meal test between mealtime URLi and lispro, and change in HbA1c from baseline to week 26 between postmeal URLi and mealtime lispro.
RESULTS


This manuscript presents pre-specified exploratory analyses of 26-week data from Japanese patients randomized to double-blind URLi (n = 62) or lispro (n = 59), or open-label URLi (n = 46). Mean baseline HbA1c levels were 7.52% for mealtime URLi, 7.44% for lispro, and 7.51% for postmeal URLi at randomization. At week 26, the least squares mean (LSM) difference compared to lispro was 0.04% (95% confidence interval [CI] - 0.14 to 0.22) for mealtime URLi, and 0.16% (95% CI - 0.04 to 0.35) for postmeal URLi. In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1- and 2-h PPG excursions during the mixed-meal tolerance test. LSM differences were - 40.5 mg/dL, 95% CI - 59.5 to 21.4 (- 2.25 mmol/L, 95% CI - 3.3 to - 1.2) for 1-h PPG excursions and - 51.7 mg/dL, 95% CI - 81.7 to - 21.8 (- 2.87 mmol/L, 95% CI - 4.5 to - 1.2) for 2-h PPG excursions at week 26. There were no significant treatment differences in rates of severe/overall hypoglycemia, or incidence of treatment-emergent adverse events.
CONCLUSIONS


Mealtime and postmeal URLi provide effective and comparable glycemic control in Japanese patients. Mealtime URLi demonstrated more effective PPG control compared to lispro.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03214367.",2020,"In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1- and 2-h PPG excursions during the mixed-meal tolerance test.","['Japanese patients', 'Japanese adults with type\xa01 diabetes mellitus from the phase\xa03 PRONTO-T1D trial', 'Japanese patients randomized to', 'Japanese Patients with Type\xa01 Diabetes']","['double-blind mealtime URLi or lispro, or 26-week open-label postmeal URLi', 'ultra-rapid lispro (URLi', 'lispro (n\u2009=\u200959), or open-label URLi', 'double-blind URLi']","['change in hemoglobin A1c (HbA1c', '2-h postprandial glucose (PPG) excursions', 'rates of severe/overall hypoglycemia, or incidence of treatment-emergent adverse events', 'Mean baseline HbA1c levels', 'LSM differences', 'Ultra-Rapid Lispro Efficacy and Safety', '1- and 2-h PPG excursions']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C1260720', 'cui_str': 'Pronto'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}]",,0.14673,"In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1- and 2-h PPG excursions during the mixed-meal tolerance test.","[{'ForeName': 'Junnosuke', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': ""Tokyo Women's Medical University School of Medicine, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Imori', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan. imori_makoto@lilly.com.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Imaoka', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00892-0']
1486,32728833,Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis.,"INTRODUCTION


The aim of this study was to evaluate the efficacy and safety of ultra-rapid lispro (URLi) versus lispro in a subgroup analysis of Japanese adults with type 2 diabetes mellitus (T2DM) from the phase 3 PRONTO-T2D trial.
METHODS


After an 8-week lead-in period during which patients transitioned to insulin lispro 3 times a day before main meals in association with basal insulin (glargine or degludec), the patients were randomized to 26 weeks of double-blind URLi or lispro injected immediately prior to meals. The primary endpoint was change in hemoglobin A1c (HbA1c) from baseline to week 26 between URLi and lispro. The multiplicity-adjusted objectives were 1- and 2-h postprandial glucose (PPG) excursions after a test meal and change in HbA1c from baseline to week 26 in the URLi and lispro groups.
RESULTS


Results were obtained from prespecified exploratory analyses of 26-week data in Japanese patients randomized to receive URLi (n = 47) or lispro (n = 46). Mean baseline HbA1c levels significantly improved during the lead-in period to a baseline value of 7.50% and 7.60% in patients subsequently randomized to the URLi and lispro treatment groups, respectively. At week 26, the least squares mean (LSM) difference in HbAc1 between the URLi and lispro groups was 0.13% (95% confidence interval [CI] - 0.12 to 0.39) (1.4 mmol/mol, 95% CI - 1.3 to 4.2). Although there were no significant differences in PPG excursions at any time-point, numerically smaller PPG excursions were consistently observed from 30 min to 3 h during the mixed-meal tolerance test in patients on URLi compared to those on lispro. LSM differences in PPG excursions at week 26 were - 10.5 mg/dL (95% CI - 32.7 to 11.7) (- 0.58 mmol/L, 95% CI - 1.82 to 0.65) at 1 h and - 14.9 mg/dL (95% CI - 40.3 to 10.5) (- 0.83 mmol/L, 95% CI - 2.24 to 0.58) at 2 h. There were no significant differences between treatments in rates of severe/overall hypoglycemia or incidence of treatment-emergent adverse events.
CONCLUSIONS


URLi administered as prandial insulin in combination with basal insulin provides effective glycemic control when administered immediately before a meal in Japanese patients with T2DM. URLi was well tolerated in this population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03214380.",2020,"Although there were no significant differences in PPG excursions at any time-point, numerically smaller PPG excursions were consistently observed from 30 min to 3 h during the mixed-meal tolerance test in patients on URLi compared to those on lispro.","['Japanese adults with type 2 diabetes mellitus (T2DM', 'Japanese Patients With Type 2 Diabetes', 'Japanese patients with T2DM']","['double-blind URLi or lispro injected immediately prior to meals', 'Humalog®', 'ultra-rapid lispro (URLi) versus lispro', 'lispro', 'URLi', 'insulin lispro 3 times a day before main meals in association with basal insulin (glargine or degludec']","['change in hemoglobin A1c (HbA1c', 'rates of severe/overall hypoglycemia or incidence of treatment-emergent adverse events', 'LSM differences in PPG excursions', 'PPG excursions', 'Mean baseline HbA1c levels', 'efficacy and safety', 'postprandial glucose (PPG) excursions', 'Ultra-Rapid Lispro Efficacy and Safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}]",,0.143219,"Although there were no significant differences in PPG excursions at any time-point, numerically smaller PPG excursions were consistently observed from 30 min to 3 h during the mixed-meal tolerance test in patients on URLi compared to those on lispro.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Jinnouchi Hospital, 6 Chome-2-3 Kuhonji, Chuo Ward, Kumamoto, 862-0976, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Imori', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K, 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan. imori_makoto@lilly.com.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K, 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Imaoka', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K, 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00890-2']
1487,32729631,Evaluation of the efficacy of pimavanserin in the treatment of agitation and aggression in patients with Alzheimer's disease psychosis: A post hoc analysis.,"OBJECTIVES


Patients with Alzheimer's disease psychosis (ADP) commonly experience concomitant agitation and aggression. We investigated whether a reduction in ADP following pimavanserin treatment conferred a reduction in associated agitation and aggression.
METHODS


ACP-103-019 was a 12-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy of pimavanserin (34 mg) in reducing psychotic symptoms in patients with ADP. The primary endpoint was change from baseline in Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS) at week six. A post hoc analysis examined whether there was a greater reduction in agitation and aggression (NPI-NH domain C [agitation/aggression] and Cohen-Mansfield Agitation Inventory-Short Form [CMAI-SF]) in pimavanserin-treated patients who experienced a reduction of hallucinations and delusions (psychosis responders defined as ≥50% reduction from baseline in NPI-NH-PS, week six) when compared with those who did not (nonresponders).
RESULTS


Pimavanserin-treated patients with ≥50% response in psychotic symptoms (n = 44) showed a greater improvement in agitation and aggression symptoms on the NPI-NH domain C (week six, least squares mean [LSM] difference = -3.64, t = -4.69, P < .0001) and the CMAI-SF (week six, LSM difference = -3.71, t = -2.01, P = .0483) than nonresponders (n = 32). Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = -3.03, t = -2.44, P = .019).
CONCLUSIONS


Patients with ADP, who show improvement in psychotic symptoms after pimavanserin treatment, also experience an improvement in concomitant agitation and aggression.",2020,"Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = ","[""patients with Alzheimer's disease psychosis"", 'patients with ADP', ""Patients with Alzheimer's disease psychosis (ADP) commonly experience concomitant agitation and aggression""]","['pimavanserin', 'placebo']","['agitation and aggression', 'severe agitation and aggression', 'concomitant agitation and aggression', 'psychotic symptoms', 'CMAI-SF', 'agitation and aggression (NPI-NH domain C [agitation/aggression] and Cohen-Mansfield Agitation Inventory-Short Form [CMAI-SF', 'agitation and aggression symptoms', 'Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.405078,"Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = ","[{'ForeName': 'Clive G', 'Initials': 'CG', 'LastName': 'Ballard', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Coate', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Abler', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Foff', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}]",International journal of geriatric psychiatry,['10.1002/gps.5381']
1488,32729835,Effects of Incentives on Adherence to a Web-Based Intervention Promoting Physical Activity: Naturalistic Study.,"BACKGROUND


Despite many advantages of web-based health behavior interventions such as wide accessibility or low costs, these interventions are often accompanied by high attrition rates, particularly in usage under real-life conditions. It would therefore be helpful to implement strategies such as the use of financial incentives to motivate program participation and increase adherence.
OBJECTIVE


This naturalistic study examined real-life usage data of a 12-week web-based physical activity (PA) intervention (Fitness Coach) among insurants who participated in an additional incentive program (incentive group) and those who did not (nonincentive group). Users in the incentive group had the perspective of receiving €30 (about US $33) cash back at the end of the intervention.
METHODS


Registration and real-life usage data as part of routine data management and evaluation of the Fitness Coach were analyzed between September 2016 and June 2018. Depending on the duration of use and the weekly recording of tasks, 4 adherence groups (low, occasional, strong, and complete adherence) were defined. Demographic characteristics were collected by a self-reported questionnaire at registration. We analyzed baseline predictors and moderators of complete adherence such as participation in the program, age, gender, and BMI using binary logistic regressions.
RESULTS


A total of 18,613 eligible persons registered for the intervention. Of these, 15,482 users chose to participate in the incentive program (incentive group): mean age 42.4 (SD 14.4) years, mean BMI 24.5 (SD 4.0) kg/m 2 , median (IQR) BMI 23.8 (21.7-26.4) kg/m 2 ; 65.12% (10,082/15,482) female; and 3131 users decided not to use the incentive program (nonincentive group): mean age 40.7 (SD 13.4) years, mean BMI 26.2 (SD 5.0) kg/m 2 , median BMI 25.3 (IQR 22.6-28.7) kg/m 2 ; 72.18% (2260/3131) female. At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group. Gender significantly moderated the effect with men in the incentive group showing higher odds to be completely adherent than women overall and men in the nonincentive group (OR 1.761). Furthermore, older age and male gender were significant predictors of complete adherence for all participants, whereas BMI did not predict intervention completion.
CONCLUSIONS


This is the first naturalistic study in the field of web-based PA interventions that shows the potential of even small financial incentives to increase program adherence. Male users, in particular, seem to be strongly motivated by incentives to complete the intervention. Based on these findings, health care providers can use differentiated incentive systems to increase regular participation in web-based PA interventions.",2020,"At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group.","['Male users', '18,613 eligible persons registered for the intervention', 'age 42.4 (SD 14.4) years, mean BMI 24.5 (SD 4.0) kg/m 2 , median (IQR) BMI 23.8 (21.7-26.4) kg/m 2 ; 65.12% (10,082/15,482) female; and 3131 users decided not to use the incentive program (nonincentive group', '15,482 users chose to participate in the incentive program (incentive group): mean', 'insurants who participated in an additional incentive program (incentive group) and those who did not (nonincentive group', 'mean age 40.7 (SD 13.4) years, mean BMI 26.2']",['12-week web-based physical activity (PA) intervention (Fitness Coach'],['complete adherence rates'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4517558', 'cui_str': '13.4'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",18613.0,0.0359261,"At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group.","[{'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Maliezefski', 'Affiliation': 'IGEL-M GbR, Bad Oldesloe, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ramsenthaler', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Brame', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}]",Journal of medical Internet research,['10.2196/18338']
1489,32726727,Effects of a health education program targeted to Chinese women adhering to their cultural practice of doing the month: A randomized controlled trial.,"BACKGROUND


""Doing the month"" is a prevalent Chinese postpartum custom which is believed to restore health after delivery. However, some traditional practices are potentially harmful for women's health.
OBJECTIVES


To examine the effect of an evidence-based health education program on Chinese postpartum women's adherence to traditional practices of doing the month and the effect of adherence to doing the month on maternal physiological and psychological health.
METHODS


A randomized controlled trial was conducted. During December 2016-July 2017, we recruited postpartum women at a tertiary hospital. Women randomized to the intervention group received evidence-based health education within 1 week after returning home and received a second visit 1 month later. The control group received routine postpartum home visits. Adherence to doing the month was measured by the Adherence to Doing-the-Month Practices questionnaire (ADP). Maternal physical health was measured by the Chair Stand Test and Postpartum Symptom Checklist. Maternal psychological health was measured by the Edinburgh Postnatal Depression Scale (EPDS). Descriptive statistics, t-test, and chi-squared test were used to analyze the differences in scores and symptoms of the two groups.
RESULTS


We recruited 124 eligible postpartum women and 108 of them (54 intervention group, 54 control group) completed this study. The ADP score of the intervention group was significantly lower than that of the control group (p < 0.001). The number of participants in the experimental group with poor appetite and indigestion was significantly lower than that of control group. No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
CONCLUSIONS


Evidence-based health education can reduce postpartum women's adherence to some traditional practices of doing the month and improve women's physical health.",2020,"No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
","['During December 2016-July 2017, we recruited postpartum women at a tertiary hospital', '124 eligible postpartum women and 108 of them (54 intervention group, 54 control group) completed this study', ""Chinese postpartum women's"", 'Chinese women adhering to their cultural practice of doing the month']","['health education program', 'routine postpartum home visits', 'evidence-based health education program', 'evidence-based health education']","['Edinburgh Postnatal Depression Scale (EPDS', 'poor appetite and indigestion', 'Maternal physical health', 'ADP score', 'Maternal psychological health', 'numbers of symptoms and average EPDS scores', 'Chair Stand Test and Postpartum Symptom Checklist']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}]",124.0,0.0672713,"No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
","[{'ForeName': 'YanQun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}, {'ForeName': 'JuYing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Obstetrics Department of Hubei Maternal and Child Health Hospital, China.'}, {'ForeName': 'XiaoLi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing, China. Electronic address: yuyun7169@163.com.'}, {'ForeName': 'JinBing', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}]",Midwifery,['10.1016/j.midw.2020.102796']
1490,32734815,Salt intake impacts sympathetic neural control but not morning blood pressure surge in premenopausal women with a history of normal pregnancy.,"Salt intake may alter blood pressure (BP) regulation, but no study has investigated the impact of salt reduction versus salt loading on morning blood pressure surge (MBPS) and sympathetic neural control in premenopausal women with a history of normal pregnancy. Nine healthy women (42 ± 3 yr; mean ± SD) were given a low-salt diet (LS; 50 mEq sodium/day) and high-salt diet (HS; 250 mEq sodium/day) for 1 wk each (~2 mo apart with the order randomized), while water intake was ad libitum. Ambulatory BP at 24 h was measured, and the percent change in blood volume (BV) was calculated following LS and HS. MBPS was defined as the morning systolic BP (averaged for 2 h after wake-up) minus the lowest nocturnal systolic BP. Beat-by-beat BP, heart rate, and muscle sympathetic nerve activity (MSNA) were measured during supine rest. Signal averaging was used to characterize changes in beat-by-beat mean arterial pressure and total vascular conductance following spontaneous MSNA bursts to assess sympathetic vascular transduction. Ambulatory BP and MBPS (32 ± 7 vs. 26 ± 12 mmHg,  P  = 0.208) did not differ between LS and HS. From LS to HS, BV increased by 4.3 ± 3.7% ( P  = 0.008). MSNA (30 ± 20 vs. 18 ± 13 bursts/100 heartbeats,  P  = 0.005) was higher, whereas sympathetic vascular transduction was lower in LS than HS (both,  P  < 0.01). Changes in MSNA from LS to HS were correlated to percent changes in BV ( r  = -0.673;  P  = 0.047). Thus, salt intake affects sympathetic neural control but not MBPS in premenopausal women with a history of normal pregnancy. The underlying mechanisms remain unknown; however, alterations in sympathetic vascular transduction may, in part, contribute. NEW & NOTEWORTHY  This is the first study to demonstrate that MBPS and ambulatory BP were not affected by salt intake despite a significant change in sympathetic outflow in healthy premenopausal women with a history of normal pregnancy. This may be due to compensatory adaptations in MSNA and sympathetic vascular transduction during salt reduction versus salt loading.",2020,"From LS to HS, BV increased by 4.3±3.7% (p=0.008).","['Nine healthy women [42±3 (SD) yr', 'premenopausal women with a history of normal pregnancy', 'Premenopausal Women with A History of Normal Pregnancy']","['Salt Intake Impacts Sympathetic Neural Control', 'low-salt (LS; 50 mEq sodium/day) and high-salt diet (HS; 250 mEq sodium/day) for 1 week each', 'salt reduction versus salt loading']","['blood pressure (BP) regulation', 'MBPS', 'morning systolic BP', 'Beat-by-beat BP, heart rate, and muscle sympathetic nerve activity (MSNA', 'blood volume (BV', 'sympathetic vascular transduction', 'Ambulatory BP and MBPS', 'nocturnal systolic BP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0232989', 'cui_str': 'Normal pregnancy'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",9.0,0.0561719,"From LS to HS, BV increased by 4.3±3.7% (p=0.008).","[{'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takeda', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Stickford', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Best', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Jeung-Ki', 'Initials': 'JK', 'LastName': 'Yoo', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00197.2020']
1491,32734929,Self-Myofascial Release Intervention and Mobile App in Patients With Hemophilic Ankle Arthropathy: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Hemophilic ankle arthropathy is manifested by degenerative functional alterations and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity.
OBJECTIVE


This study aims to evaluate the safety and efficacy of a protocol using self-myofascial release with a foam roller to be applied in patients with hemophilic ankle arthropathy.
METHODS


Patients with ankle arthropathy (N=70) will be recruited, enrolled, and assigned to one of two groups-experimental or control-in a 1:1 allocation ratio. Patients will be recruited from 5 centers in different regions of Spain. Patient data will be collected at baseline, posttreatment, and follow-up. The primary outcome will be frequency of ankle joint bleeding (self-reported). The secondary outcomes will be ankle range of motion (measured with a digital goniometer); joint pain (measured with a visual analog scale and an algometer); joint status (measured using the Hemophilia Joint Health Score); muscle strength (measured with a dynamometer); functionality of lower limbs (measured using the 6-minute walking test); activity (self-reported); and muscle flexibility (measured using the fingertip-to-floor test). The treatment program includes 11 exercises that must be administered bilaterally. A mobile app will be developed where each patient will be able to observe the exercises to be carried out. Each session will last 15 minutes with 5 physiotherapy sessions per week for a period of 3 months. It is expected that patients with hemophilia who receive the foam roller intervention will show improvement in mobility, pain, and status of the ankle joint; muscle strength; and function in the lower extremities.
RESULTS


The study has been approved by the institutional review board of the University of Murcia. Patient recruitment will begin in September 2020, and the intervention period will last until June 2021. Data collection will take place between September 2020 and October 2021.
CONCLUSIONS


This protocol describes a randomized clinical trial to examine the safety and efficacy of a self-myofascial release intervention using a foam roller in patients with hemophilic ankle arthropathy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03914287; http://clinicaltrials.gov/ct2/show/NCT03914287.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/15612.",2020,"It is expected that patients with hemophilia who receive the foam roller intervention will show improvement in mobility, pain, and status of the ankle joint; muscle strength; and function in the lower extremities.
","['Patients', 'Patients with ankle arthropathy (N=70', 'patients with hemophilia', 'Patients will be recruited from 5 centers in different regions of Spain', 'patients with hemophilic ankle arthropathy']","['Self-Myofascial Release Intervention and Mobile App', 'self-myofascial release intervention']","['frequency of ankle joint bleeding (self-reported', 'safety and efficacy', 'mobility, pain, and status of the ankle joint; muscle strength; and function', 'ankle range of motion (measured with a digital goniometer); joint pain (measured with a visual analog scale and an algometer); joint status (measured using the Hemophilia Joint Health Score); muscle strength (measured with a dynamometer); functionality of lower limbs (measured using the 6-minute walking test); activity (self-reported); and muscle flexibility (measured using the fingertip-to-floor test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0741040', 'cui_str': 'Ankle arthropathy'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}]",,0.163128,"It is expected that patients with hemophilia who receive the foam roller intervention will show improvement in mobility, pain, and status of the ankle joint; muscle strength; and function in the lower extremities.
","[{'ForeName': 'Antonio Javier', 'Initials': 'AJ', 'LastName': 'Meroño-Gallut', 'Affiliation': 'Tú. Bienestar 360º, Physiotherapy and Medical Center, San Javier-Murcia, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Cuesta-Barriuso', 'Affiliation': 'Department of Physiotherapy, European University of Madrid, Madrid, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Pérez-Llanes', 'Affiliation': 'Department of Physiotherapy, Catholic University San Antonio-UCAM, Murcia, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Donoso-Úbeda', 'Affiliation': 'Optimus Osteopathy and Physiotherapy Clinic, Murcia, Spain.'}, {'ForeName': 'José-Antonio', 'Initials': 'JA', 'LastName': 'López-Pina', 'Affiliation': 'Department of Basic Phycology and Methodology, University of Murcia, Murcia, Spain.'}]",JMIR research protocols,['10.2196/15612']
1492,32730797,Balance training monitoring and individual response during unstable vs. stable balance Exergaming in elderly adults: Findings from a randomized controlled trial.,"OBJECTIVE


Exercise-based fall prevention programs mainly refer to multimodal and challenging balance exercises. Individual load monitoring and interpretations are crucial to enable adequate adaptation responses on the individual level. Thus, assessing internal responses to external stimuli throughout an intervention period need to be adequately addressed. The aim of this secondary analysis of a 3-armed randomized controlled trial was to analyze internal and external loads of unstable vs. stable balance Exergame training in healthy seniors. We intended to elucidate whether differences of external and internal load criteria occur over the intervention period.
METHODS


A total of 51 healthy seniors (females: n = 34; males: n = 17; age: 69 ± 6 years; BMI: 27 ± 5) were allocated to either volitional stepping (VOL), volitional stepping under unstable conditions (VOL + US) or an inactive control group (CON). VOL and VOL + US completed 8 weeks of Exergame based step training (three weekly sessions, 45 min each) using the Dividat Senso device. Twelve different balance Exergames were used, consisting of virtual reality like video games. The original nonswinging, stable platform was employed for VOL, whereas VOL + US used an adapted Senso mounted on a swinging Posturomed Rack. The instability level was increased for VOL + US only every second week. External (game scores) and internal (perceived efforts, using the rated perceived exertion scale (RPE)) load measures were individually recorded for every session. Statistical analysis was carried out using linear mixed-effects modelling.
RESULTS


Although VOL + US completed similar games at identical training volumes under unstable conditions, the achieved game scores did not significantly differ between both training groups (p = 0.71). Both intervention groups notably improved their game scores over the 8 training weeks (p < 0.01). A significant time x group interaction effect was observed for perceived effort (p < 0.01), serving as an internal load measure. Subsequent post-hoc testing revealed significant greater perceived exertion values in each of the first 7 weeks (p < 0.05) in VOL + US compared to VOL. No between-group differences were found for RPE in week 8. Whereas RPE values in VOL + US decreased over time (week 1: 4.6 ± 1.9; week 8: 3.1 ± 1.6), VOL indicated similar RPE values for all weeks (week 1: 3.1 ± 1.3; week 8: 2.9 ± 1.4). A detailed analysis of all twelve games revealed that differences in perceived exertion depend on the game content: in 75% of the involved games the RPE level was significantly higher in VOL + US compared to VOL (p < 0.05).
CONCLUSION


Monitoring internal and external loads on individual level are paramount for gaining adequate training adaptations. Our results indicate that between-group differences in perceived efforts a) can funnel over time, b) depend on game content and c) do not necessarily affect overall scoring. Future studies should individually employ and monitor measures of perceived efforts to guarantee an adequate challenge to the balance system within exercise-based fall prevention programs.",2020,Both intervention groups notably improved their game scores over the 8 training weeks (p < 0.01).,"['51 healthy seniors (females: n\u202f=\u202f34; males: n\u202f=\u202f17; age: 69\u202f±\u202f6\u202fyears; BMI: 27\u202f±\u202f5', 'healthy seniors', 'elderly adults']","['unstable vs. stable balance Exergame training', 'volitional stepping (VOL), volitional stepping under unstable conditions (VOL\u202f+\u202fUS) or an inactive control group (CON', 'Balance training monitoring', 'Exercise-based fall prevention programs']","['instability level', 'game scores', 'perceived exertion', 'RPE values', 'exertion values', 'RPE level', 'External (game scores) and internal (perceived efforts, using the rated perceived exertion scale (RPE)) load measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",51.0,0.0158194,Both intervention groups notably improved their game scores over the 8 training weeks (p < 0.01).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University, Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University, Cologne, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rein', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University, Cologne, Germany. Electronic address: r.rein@dshs-koeln.de.'}]",Experimental gerontology,['10.1016/j.exger.2020.111037']
1493,32730798,"Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.","BACKGROUND


Cushing's disease is a rare endocrine disorder characterised by cortisol overproduction with severe complications. Therapies for cortisol reduction are often necessary. Here we report the outcomes from the pivotal phase III study of osilodrostat (a potent oral inhibitor of cytochrome P450 11B1, mitochondrial [11β-hydroxylase]; Novartis Pharma AG, Basel, Switzerland) in patients with Cushing's disease.
METHODS


LINC 3 was a prospective, multicentre, open-label, phase III study with a double-blind randomised withdrawal period, that comprised four periods. Patients aged 18-75 years, with confirmed persistent or recurrent Cushing's disease (defined as mean 24-h urinary free cortisol [UFC] concentration >1·5 times the upper limit of normal [ULN] and morning plasma adrenocorticotropic hormone above the lower limit of normal) who had previously had pituitary surgery or irradiation, or were newly diagnosed and who refused surgery or were not surgical candidates, were recruited from 66 hospital sites and private clinical practices in 19 countries. In period 1, open-label osilodrostat was initiated in all participants and adjusted every 2 weeks (1-30 mg twice daily; film-coated tablets for oral administration) on the basis of mean 24-h UFC concentration and safety until week 12. In period 2, weeks 13-24, osilodrostat was continued at the therapeutic dose determined during period 1. In period 3, beginning at week 26, participants who had a mean 24-h UFC concentration of less than or equal to the ULN at week 24, without up-titration after week 12, were randomly assigned (1:1), via an interactive-response technology, stratified by osilodrostat dose at week 24 and history of pituitary irradiation, to continue osilodrostat or switch to placebo for 8 weeks. Participants and investigators were masked to treatment assignment. Ineligible participants continued open-label osilodrostat. In period 4, weeks 35-48, all participants were given open-label osilodrostat until core-study end. The primary objective was to compare the efficacy of osilodrostat versus placebo at the end of period 3. The primary endpoint was the proportion of participants who had been randomly assigned to treatment or placebo with a complete response (ie, mean 24-h UFC concentration of ≤ULN) at the end of the randomised withdrawal period (week 34), without up-titration during this period. The key secondary endpoint was the proportion of participants with a complete response at the end of the single-arm, open-label period (ie, period 2, week 24) without up-titration during weeks 13-24. Analysis was by intention-to-treat for all patients who received at least one dose of osilodrostat (full analysis set; key secondary endpoint) or randomised treatment (randomised analysis set; primary endpoint) and safety was assessed in all enrolled patients who received at least one dose of osilodrostat and had at least one post-baseline safety assessment. LINC 3 is registered with ClinicalTrials.gov, NCT02180217, and is now complete.
FINDINGS


Between Nov 12, 2014, and March 22, 2017, 202 patients were screened and 137 were enrolled. The median age was 40·0 years (31·0-49·0) and 106 (77%) participants were female. 72 (53%) participants were eligible for randomisation during the withdrawal phase, of whom 36 were assigned to continue osilodrostat and 35 were assigned to placebo; one patient was not randomly assigned due to investigator decision and continued open-label osilodrostat. More patients maintained a complete response with osilodrostat versus with placebo at week 34 (31 [86%] vs ten [29%]; odds ratio 13·7 [95% CI 3·7-53·4]; p<0·0001). At week 24, 72 (53%; 95% CI 43·9-61·1) of 137 patients maintained a complete response without up-titration after week 12. Most common adverse events (ie, occurred in >25% of participants) were nausea (57 [42%]), headache (46 [34%]), fatigue (39 [28%]), and adrenal insufficiency (38 [28%]). Hypocortisolism occurred in 70 (51%) patients and adverse events related to adrenal hormone precursors occurred in 58 (42%) patients. One patient died, unrelated to study drug, after the core study phase.
INTERPRETATION


Twice-daily osilodrostat rapidly reduced mean 24-h UFC and sustained this reduction alongside improvements in clinical signs of hypercortisolism; it was also generally well tolerated. Osilodrostat is an effective new treatment option that is approved in Europe for the treatment of endogenous Cushing's syndrome and in the USA for Cushing's disease.
FUNDING


Novartis Pharma AG.",2020,More patients maintained a complete response with osilodrostat versus with placebo at week 34 (31 [86%] vs ten [29%]; odds ratio 13·7 [95% CI 3·7-53·4]; p<0·0001).,"[""patients with Cushing's disease"", '72 (53%) participants were eligible for randomisation during the withdrawal phase, of whom 36 were assigned to continue osilodrostat and 35 were assigned to', 'participants who had a mean 24-h UFC concentration of less than or equal to the ULN at week 24, without up-titration after week 12', 'Between Nov 12, 2014, and March 22, 2017, 202 patients were screened and 137 were enrolled', '137 patients', 'The median age was 40·0 years (31·0-49·0) and 106 (77%) participants were female', ""Patients aged 18-75 years, with confirmed persistent or recurrent Cushing's disease (defined as mean 24-h urinary free cortisol [UFC] concentration >1·5 times the upper limit of normal [ULN] and morning plasma adrenocorticotropic hormone above the lower limit of normal) who had previously had pituitary surgery or irradiation, or were newly diagnosed and who refused surgery or were not surgical candidates, were recruited from 66 hospital sites and private clinical practices in 19 countries"", ""patients with Cushing's disease (LINC 3""]","['osilodrostat versus placebo', 'investigator decision and continued open-label osilodrostat', 'osilodrostat', 'placebo']","['headache', 'adrenal hormone precursors', 'proportion of participants with a complete response', 'fatigue', 'complete response (ie, mean 24-h UFC concentration of ≤ULN', 'Efficacy and safety', 'adrenal insufficiency', 'nausea', 'Hypocortisolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1271647', 'cui_str': 'Plasma ACTH level'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0001403', 'cui_str': ""Addison's disease""}]",202.0,0.359008,More patients maintained a complete response with osilodrostat versus with placebo at week 34 (31 [86%] vs ten [29%]; odds ratio 13·7 [95% CI 3·7-53·4]; p<0·0001).,"[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Pivonello', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università Federico II di Napoli, Naples, Italy. Electronic address: rosario.pivonello@unina.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Northwest Pituitary Center, Departments of Medicine and Neurological Surgery, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Newell-Price', 'Affiliation': 'Department of Oncology and Metabolism, The Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bertagna', 'Affiliation': 'Department of Endocrinology, Centre de Référence des Maladies Rares de la Surrénale, Hôpital Cochin, Faculté de Médecine Paris Descartes, Université Paris 5, Paris, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Findling', 'Affiliation': 'Division of Endocrinology and Molecular Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimatsu', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan; Advanced Medical Care Center, Kusatsu General Hospital, Kusatsu, Japan.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Auchus', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rattana', 'Initials': 'R', 'LastName': 'Leelawattana', 'Affiliation': 'Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Eun Jig', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Pituitary Tumor Center, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': ""Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Laplanche', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Connell"", 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Libuse', 'Initials': 'L', 'LastName': 'Tauchmanova', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Pedroncelli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Beverly M K', 'Initials': 'BMK', 'LastName': 'Biller', 'Affiliation': 'Neuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30240-0']
1494,32730905,Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial.,"BACKGROUND


New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization.
STUDY DESIGN


This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months.
SUMMARY


This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.",2020,"The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months.","['200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI', 'patients with peripheral artery disease (PAD) undergoing arterial angioplasty', 'patients undergoing InfraPoPliteal angioplasty for critical limb ischemia', 'patients with CLI undergoing endovascular infrapopliteal revascularization', 'patients undergoing endovascular infrapopliteal revascularization']","['apixaban plus aspirin', 'apixaban 2.5 mg twice daily plus aspirin', 'Apixaban versus ClopidoGRel', 'standard of care dual antiplatelet therapy (DAPT', 'DAPT (clopidogrel plus aspirin', 'aspirin', 'clopidogrel', 'oral apixaban']","['composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death', 'thrombotic restenosis and artery re-occlusion', 'composite of major bleeding or clinically relevant non-major bleeding at 12 months', 'efficacy and safety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0397654', 'cui_str': 'Angioplasty of artery'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3530461', 'cui_str': 'apixaban 2.5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.221901,"The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months.","[{'ForeName': 'Rodrigo Bruno', 'Initials': 'RB', 'LastName': 'Biagioni', 'Affiliation': 'São Paulo State Public Servant Hospital, São Paulo, Brazil. Electronic address: rbbiagioni@gmail.com.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Leandro Barile', 'Initials': 'LB', 'LastName': 'Agati', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacilotto', 'Affiliation': 'São Paulo State Public Servant Hospital, São Paulo, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wolosker', 'Affiliation': 'Albert Einstein Hospital, São Paulo, Brazil; Hospital das Clínicas de São Paulo, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Marcone Lima', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Universidade Estadual Paulista (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Bruno Leonardo', 'Initials': 'BL', 'LastName': 'de Freitas Soares', 'Affiliation': 'Santa Casa de Maceio, Maceio, Alagoas, Brazil.'}, {'ForeName': 'Edwaldo Edner', 'Initials': 'EE', 'LastName': 'Joviliano', 'Affiliation': 'Hospital das Clínicas de Ribeirão Preto, São Paulo University Medical School (USP), Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Walkiria Hueb', 'Initials': 'WH', 'LastName': 'Bernardi', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Valter Castelli', 'Initials': 'VC', 'LastName': 'Junior', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Roberto Augusto', 'Initials': 'RA', 'LastName': 'Caffaro', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Fioranelli', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Bonno', 'Initials': 'B', 'LastName': 'Van Bellen', 'Affiliation': 'Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ivan Benaduce', 'Initials': 'IB', 'LastName': 'Casella', 'Affiliation': 'Hospital das Clínicas de São Paulo, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Ronald José Ribeiro', 'Initials': 'RJR', 'LastName': 'Fidelis', 'Affiliation': 'Vascular and Endovascular Surgery-Federal University of Bahia.'}, {'ForeName': 'Ronald Luiz Gomes', 'Initials': 'RLG', 'LastName': 'Flumignan', 'Affiliation': 'Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anthony James', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ramacciotti', 'Affiliation': 'Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center, Maywood, IL, USA; Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}]",American heart journal,['10.1016/j.ahj.2020.06.010']
1495,32731365,Effectiveness of Resistance Training with the Use of a Suspension System in Patients after Myocardial Infarction.,"The aim of the study was to assess the effects of resistance training with the use of a suspension system on exercise tolerance, evaluated through an exercise test, and the changes in selected echocardiographic parameters of patients after myocardial infarction. The study involved 44 males. The subjects were divided into two groups: Standard (20) and Suspension system (24). All the subjects had undergone an angioplasty with stent implantation. The standard and suspension system groups carried out a 24-day improvement program comprising 22 training units. Each session consisted of endurance, general stamina and resistance training. Instead of resistance training, the experimental group made multijoint exercises with a suspension system. Statistically significant changes in both groups were observed in the parameters of the echocardiographic exercise test, such as test duration ( p  = 0.000), distance covered ( p  = 0.000), MET ( p  = 0.000), VO2max ( p  = 0.000) and SBPrest ( p  = 0.013). Additionally, SBPmax in the suspension system group improved ( p  = 0.035). The echocardiographic test revealed significant improvement of Left Ventricular Ejection Fraction in both groups (SP group  p  = 0.001, standard group  p  = 0.005). The lipid profile test in the SP group revealed statistically significant improvement of TC ( p  = 0.003), HDL ( p  = 0.000) and LDL ( p  = 0.005). Training with the suspension system had a positive effect on the change of exercise tolerance level, left ventricular function and blood lipid profile.",2020,"The echocardiographic test revealed significant improvement of Left Ventricular Ejection Fraction in both groups (SP group  p  = 0.001, standard group  p  = 0.005).","['patients after myocardial infarction', 'Patients after Myocardial Infarction', '44 males']","['angioplasty with stent implantation', 'endurance, general stamina and resistance training', 'Resistance Training', 'resistance training']","['exercise tolerance level, left ventricular function and blood lipid profile', 'echocardiographic exercise test, such as test duration', 'Left Ventricular Ejection Fraction', 'LDL', 'VO2max', 'HDL', 'TC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0429930', 'cui_str': 'Test duration'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",44.0,0.0138713,"The echocardiographic test revealed significant improvement of Left Ventricular Ejection Fraction in both groups (SP group  p  = 0.001, standard group  p  = 0.005).","[{'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Nowak', 'Affiliation': ""Department of Physiotherapy, Jerzy Kukuczka's Academy of Physical Education, 40-065 Katowice, Poland.""}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Morawiec', 'Affiliation': 'Uppersilesian Center of Medicine and Rehabilitation AMED, 40-514 Katowice, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Gabrys', 'Affiliation': 'Department of Physical Education and Sport Science, Faculty of Pedagogy, University of West Bohemia, 301 00 Pilsen, Czech Republic.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Nowak', 'Affiliation': ""Department of Physiotherapy, Jerzy Kukuczka's Academy of Physical Education, 40-065 Katowice, Poland.""}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Szmatlan-Gabryś', 'Affiliation': 'Department Anathomy Faculty of Rehabilitation University of Physical Education, 31-571 Krakow, Poland.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Salcman', 'Affiliation': 'Department of Physical Education and Sport Science, Faculty of Pedagogy, University of West Bohemia, 301 00 Pilsen, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17155419']
1496,32731424,Healthy Promotion for Fighting Metabolic Syndrome: Insights from Multi-Center HeRO-FiT Cohort.,"We know that metabolic syndrome (MS) is a modern cardiovascular (CV) ""epidemic"", especially in western populations. MS is indeed strictly related to the risk of developing CV diseases (CVD) and/or diabetes. Therefore, the aim of our multi-center study was to promote a ""healthy style"" for fighting MS. Each participating center analyzed its own database of outpatients and globally we have pulled out 100 volunteers to participate in the study. Before starting, we collected their written consent. Enrolled subjects have not any history of overt CVD and/or diabetes, but they matched National Cholesterol Education Program/Adult Treatment Panel (NCEP/ATP) criteria for MS. After enrolment (t0), subjects were randomly divided into two homogeneous groups: a) only diet suggestions; b) both diet and exercise prescription. Later, we measured for each subject: blood pressure (BP), heart rate (HR), height, weight, body mass index (BMI), waist circumference (WC), waist hip ratio (WHR), six-minute walking test (WT6M), distance and common blood tests such as fasting plasma glucose, high-density lipoproteins (HDL) and triglycerides (T1 assessments). At six months (T2), the same parameters were measured and then statistical comparisons were performed. Attention to diet caused significant changes only in WC and WHR, whilst a coupling of exercise and diet revealed a statistically significant improvement in HR, BP, BMI, blood samplings and WT6M too. In conclusion, a healthy lifestyle should be more encouraged by physicians and/or collaborators (such as dieticians) operating in preventive settings. Diet and physical activity may be early useful strategies in the ""battle"" against MS even before any medication choices. Further studies will be necessary in order to better address the topic.",2020,"Attention to diet caused significant changes only in WC and WHR, whilst a coupling of exercise and diet revealed a statistically significant improvement in HR, BP, BMI, blood samplings and WT6M too.","['Enrolled subjects have not any history of overt CVD and/or diabetes, but they matched National Cholesterol Education Program/Adult Treatment Panel (NCEP/ATP) criteria for MS', 'Each participating center analyzed its own database of outpatients and globally we have pulled out 100 volunteers to participate in the study']",['diet and exercise prescription'],"['WC and WHR', 'HR, BP, BMI, blood samplings and WT6M too', 'blood pressure (BP), heart rate (HR), height, weight, body mass index (BMI), waist circumference (WC), waist hip ratio (WHR), six-minute walking test (WT6M), distance and common blood tests such as fasting plasma glucose, high-density lipoproteins (HDL) and triglycerides (T1 assessments']","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",100.0,0.0113874,"Attention to diet caused significant changes only in WC and WHR, whilst a coupling of exercise and diet revealed a statistically significant improvement in HR, BP, BMI, blood samplings and WT6M too.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Gianturco', 'Affiliation': 'Hospital for the Elderly ""Madonna del Divino Amore"", Via Casilina, 1839, 00132 Borghesiana, Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Gianturco', 'Affiliation': 'ASST Rhodense, Cardiac-Rehab Unit, Passirana-Rho Hospital, Via Luigi Settembrini, 1, 20017 Rho Milan, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Regnoli', 'Affiliation': 'IRCCS Galeazzi Orthopedic Institute, Dietician Service, Via Riccardo Galeazzi, 4, 20161 Milan, Italy.'}, {'ForeName': 'Bruno Dino', 'Initials': 'BD', 'LastName': 'Bodini', 'Affiliation': 'ASST Rhodense, Pulmonology Rehab Unit, Passirana-Rho Hospital, Via Luigi Settembrini, 1, 20017 Rho Milan, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Turiel', 'Affiliation': 'IRCCS Galeazzi Orthopedic Institute, Cardiology Unit, Via Riccardo Galeazzi, 4, 20161 Milan, Italy.'}, {'ForeName': 'Martino', 'Initials': 'M', 'LastName': 'Trapani', 'Affiliation': 'ASST Rhodense, Public Health Division, Garbagnate Hospital, Via Carlo Forlanini, 20024 Garbagnate Milanese Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bini', 'Affiliation': 'ASST Rhodense, Chief of Pulmonology, Garbagnate Hospital, Via Carlo Forlanini, 20024 Garbagnate Milanese Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Angelis', 'Affiliation': 'ASST Rhodense, Cardiac-Rehab Unit, Passirana-Rho Hospital, Via Luigi Settembrini, 1, 20017 Rho Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17155424']
1497,32731825,Migration of a novel 3D-printed cementless versus a cemented total knee arthroplasty: two-year results of a randomized controlled trial using radiostereometric analysis.,"AIMS


Although bone cement is the primary mode of fixation in total knee arthroplasty (TKA), cementless fixation is gaining interest as it has the potential of achieving lasting biological fixation. By 3D printing an implant, highly porous structures can be manufactured, promoting osseointegration into the implant to prevent aseptic loosening. This study compares the migration of cementless, 3D-printed TKA to cemented TKA of a similar design up to two years of follow-up using radiostereometric analysis (RSA) known for its ability to predict aseptic loosening.
METHODS


A total of 72 patients were randomized to either cementless 3D-printed or a cemented cruciate retaining TKA. RSA and clinical scores were evaluated at baseline and postoperatively at three, 12, and 24 months. A mixed model was used to analyze the repeated measurements.
RESULTS


The mean maximum total point motion (MTPM) at three, 12, and 24 months was 0.33 mm (95% confidence interval (CI) 0.25 to 0.42), 0.42 mm (95% CI 0.33 to 0.51), and 0.47 mm (95% CI 0.38 to 0.57) respectively in the cemented group, versus 0.52 mm (95% CI 0.43 to 0.63), 0.62 mm (95% CI 0.52 to 0.73), and 0.64 mm (95% CI 0.53 to 0.75) in the cementless group (p = 0.003). However, using three months as baseline, no difference in mean migration between groups was found (p = 0.497). Three implants in the cemented group showed a > 0.2 mm increase in MTPM between one and two years of follow-up. In the cementless group, one implant was revised due to pain and progressive migration, and one patient had a liner-exchange due to a deep infection.
CONCLUSION


The cementless TKA migrated more than the cemented TKA in the first two-year period. This difference was mainly due to a higher initial migration of the cementless TKA in the first three postoperative months after which stabilization was observed in all but one malaligned and early revised TKA. Whether the biological fixation of the cementless implants will result in an increased long-term survivorship requires a longer follow-up. Cite this article:  Bone Joint J  2020;102-B(8):1016-1024.",2020,Three implants in the cemented group showed a > 0.2 mm increase in MTPM between one and two years of follow-up.,['72 patients'],"['cementless 3D-printed or a cemented cruciate retaining TKA', 'novel 3D-printed cementless versus a cemented total knee arthroplasty', 'cemented TKA']","['mean maximum total point motion (MTPM', 'RSA and clinical scores', 'MTPM', 'mean migration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}]",72.0,0.134871,Three implants in the cemented group showed a > 0.2 mm increase in MTPM between one and two years of follow-up.,"[{'ForeName': 'Shaho', 'Initials': 'S', 'LastName': 'Hasan', 'Affiliation': 'Department of Orthopaedic Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Koen T', 'Initials': 'KT', 'LastName': 'van Hamersveld', 'Affiliation': 'Department of Orthopaedic Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Perla J', 'Initials': 'PJ', 'LastName': 'Marang-van de Mheen', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Kaptein', 'Affiliation': 'Department of Orthopaedic Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Rob G H H', 'Initials': 'RGHH', 'LastName': 'Nelissen', 'Affiliation': 'Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Toksvig-Larsen', 'Affiliation': 'Department of Orthopaedic Surgery, Hässleholm Hospital, Hässleholm, Sweden.'}]",The bone & joint journal,['10.1302/0301-620X.102B8.BJJ-2020-0054.R1']
1498,32736216,Combined exercise training improves cognitive functions in multiple sclerosis patients with cognitive impairment: A single-blinded randomized controlled trial.,"BACKGROUND


Cognitive impairment is common in patients with multiple sclerosis (MS). The effects of different exercise trainings on cognitive functions in patients with MS are promising. However, the effects are not yet clear in MS patients with cognitive impairment. This study aimed to investigate the effect of combined exercise training on different cognitive functions in MS patients with cognitive impairment.
METHODS


Relapsing-remitting and mild disabled MS patients with cognitive impairment were randomly assigned to two groups: Exercise Group (EG, n:17) and the Control Group (CG, n:17). The EG received a combined exercise training consisting of aerobic and Pilates training in three sessions per week for 8 weeks while the CG performed the relaxation exercises at home. Cognitive functions, walking capacity, fatigue, mood, and quality of life were assessed at baseline and after eight weeks using the Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively.
RESULTS


This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003). Moreover, verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory increased in the CG (p<0.05). Furthermore, the change in visuospatial memory was associated with the change in mental quality of life (r:0.352, p: 0.041) while the change in verbal fluency (r: -0.362, p:0.035) and processing speed (r: -0.356, p:0.039) were associated with the change in mood.
CONCLUSION


Combined exercise training has beneficial effects on different cognitive functions in mild disabled RRMS patients with cognitive impairment. In addition, there is a mutual relationship in improvements in cognitive functions, mood, and quality of life after exercise.",2020,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","['mild disabled RRMS patients with cognitive impairment', 'multiple sclerosis patients with cognitive impairment', 'patients with MS', 'Relapsing-remitting and mild disabled MS patients with cognitive impairment', 'patients with multiple sclerosis (MS', 'MS patients with cognitive impairment']","['Combined exercise training', 'combined exercise training consisting of aerobic and Pilates training', 'exercise trainings', 'Exercise Group (EG, n:17) and the Control Group (CG, n:17', 'combined exercise training']","['change in visuospatial memory', 'verbal fluency', 'long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life', 'processing speed', 'Cognitive functions, walking capacity, fatigue, mood, and quality of life', 'cognitive functions', ""Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively"", 'verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory', 'mental quality of life', 'cognitive functions, mood, and quality of life']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0502248,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey. Electronic address: caglaozkul@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102419']
1499,32737183,Effects of Inactivation of the Periaqueductal Gray on Song Production in Testosterone-Treated Male Canaries ( Serinus canaria ).,"Male canaries ( Serinus canaria ) display seasonal changes in the motivation to sing which have been found to be dependent on the action of testosterone (T). During the breeding season when T is high, males sing at a higher rate compared with males with low T. The effect of T on song rate is known to be mediated by the medial preoptic nucleus (POM); however, it is unclear how T signaling in POM impacts song production. One potential mechanism is via modulation of dopaminergic input into song control nuclei by the periaqueductal gray (PAG). In order to test the role of PAG in T-mediated song production, we treated male canaries with peripheral T implants and implanted a guide cannula targeting the PAG. Through this guide cannula, we transiently inactivated PAG with injections of the GABA A  agonist, muscimol. Each bird received multiple infusions of both muscimol and saline with a 48-h washout period between treatments. The order of injection type was randomized and counterbalanced between individuals. Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection. These results support the hypothesis that PAG is involved in the production of song, potentially mediating the motivation to sing or alternatively interfering with the pre-motor activity of nucleus RA. Other song features were however not affected.",2020,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.",['Testosterone-Treated Male Canaries ( Serinus canaria '],['muscimol and saline'],[],"[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C1095844', 'cui_str': 'Serinus canaria'}]","[{'cui': 'C0026818', 'cui_str': 'Muscimol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.0304729,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.","[{'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Haakenson', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742, chaakens@umd.edu.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Balthazart', 'Affiliation': 'Laboratory of Behavioral Neuroendocrinology, GIGA Neurosciences, University of Liege, 15 Avenue Hippocrate, 4000, Liege, Belgium.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Ball', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742.'}]",eNeuro,['10.1523/ENEURO.0048-20.2020']
1500,32738042,Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty.,"CONTEXT


Gonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP). A 6-month subcutaneous injection has recently been approved by the Food and Drug Administration.
OBJECTIVE


Determine efficacy, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for CPP.
DESIGN


Phase 3 multicenter, open-label, single-arm study.
SETTING


25 sites in 6 countries.
SUBJECTS


64 GnRHa-naïve children with CPP (age: 7.5 ± 0.1 years) received study drug: 59 completed the study.
INTERVENTION(S)


2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks; children were followed for 48 weeks.
MAIN OUTCOME MEASURE(S)


Percentage of children with serum luteinizing hormone (LH) <4 IU/L 30 minutes following GnRHa stimulation at week 24.
RESULTS


54/62 (87%) children achieved poststimulation LH <4 IU/L at week 24; 49/56 (88%) girls and 1/2 boys maintained peak LH <4 IU/L at week 48. Mean growth velocity decreased from 8.9 cm/year at week 4 to 6.0 cm/year at week 48. Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48. Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys. Adverse events were mild and did not cause treatment discontinuation.
CONCLUSIONS


A small volume of 45-mg subcutaneous leuprolide acetate administered at a 6-month interval effectively suppressed pubertal hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.",2020,Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys.,"['Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48', '64 GnRHa naive children with CPP (age: 7.5±0.1 years) received study drug: 59 completed the study', 'children with CPP', '25 sites in 6 countries', 'central precocious puberty']","['Gonadotropin releasing hormone agonists (GnRHa', 'leuprolide acetate treatment', 'leuprolide acetate', 'subcutaneous leuprolide acetate', 'luteinizing hormone (LH', '6-month 45 mg subcutaneous leuprolide acetate']","['pubertal hormones and stopped or caused regression of pubertal progression', 'Mean growth velocity', 'Adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429620', 'cui_str': 'Bone age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0342543', 'cui_str': 'Central precocious puberty'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0700596', 'cui_str': 'Leuprolide acetate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0790454,Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys.,"[{'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Klein', 'Affiliation': ""Rady Children's Hospital and University of California, San Diego, California.""}, {'ForeName': 'Analía', 'Initials': 'A', 'LastName': 'Freire', 'Affiliation': 'Centro de Investigaciones Endocrinológicas ""Dr. César Bergadá"" (CEDIE) CONICET - FEI - División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina.'}, {'ForeName': 'Mirta Graciela', 'Initials': 'MG', 'LastName': 'Gryngarten', 'Affiliation': 'Centro de Investigaciones Endocrinológicas ""Dr. César Bergadá"" (CEDIE) CONICET - FEI - División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina.'}, {'ForeName': 'Gad B', 'Initials': 'GB', 'LastName': 'Kletter', 'Affiliation': 'MultiCare Institute for Research and Innovation, Tacoma, Washington.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Benson', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida.""}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Miller', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota.""}, {'ForeName': 'Tala S', 'Initials': 'TS', 'LastName': 'Dajani', 'Affiliation': 'School of Osteopathic Medicine in Arizona, A.T. Still University, Mesa, Arizona.'}, {'ForeName': 'Erica A', 'Initials': 'EA', 'LastName': 'Eugster', 'Affiliation': 'Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mauras', 'Affiliation': ""Nemours Children's Health System, Jacksonville, Florida.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa479']
1501,32736046,"Evaluation of sedative effects of an intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double-dummy, double-blind placebo controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian Medicine (TPM) has been established as a valuable source of medicinal plants for the treatment of insomnia for thousands of years. Accordingly, oil extracts from plants' parts have been widely used to alleviate central nervous system (CNS) ailments including sleep disorders. A number of preparations have been recommended by TPM for the treatment of insomnia. Among them, an intranasal formulation containing oily macerates of Viola odorata L., Crocus sativus L. and Lactuca sativa L. stands out.
AIM OF THE STUDY


In the present double-dummy, double-blind placebo controlled clinical trial, we aim to evaluate the effectiveness of a combination of violet oil, saffron oil, and lettuce seeds oil nasal drop compared with the placebo (sesame oil).
MATERIALS AND METHODS


Fifty patients with primary chronic insomnia were randomly assigned in TPM-treatment or placebo groups, received either two drops of the herbal oil or placebo into each nostril every noon and evening for 8 weeks. Before the study commencement and after 1, 4 and 8 weeks of treatment, Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all patients. The primary outcome measure was considered as any changes in ISI scores between the first visit and after 8 weeks. Changes in PSQI scores during the study and possible side effects were also assessed. The multicompound herbal oil was standardized using HPLC analysis and contained 0.02 mg/mL crocin and 4 μg/mL isoquercitrin.
RESULTS


Our study revealed a significant reduction in the ISI and PSQI scores from baseline by the study endpoint (P ≤ 0.01). The mean ISI scores in week 8 decreased significantly for the intervention group (P = 0.001) and also the placebo group (P < 0.01) when compared with baseline. Moreover, the use of hypnotic drugs in the intervention group was significantly reduced (P < 0.001), while in the control group was maintained at baseline level.
CONCLUSIONS


It seems that intranasal use of the multi-herbal preparation can be used to improve chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients.",2020,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"['primary chronic insomnia', 'Fifty patients with primary chronic insomnia']","['violet oil, saffron oil, and lettuce seeds oil nasal drop', 'placebo (sesame oil', 'TPM-treatment or placebo', 'TPM', 'intranasal dosage form containing saffron, lettuce seeds and sweet violet', 'herbal oil or placebo', 'placebo']","['ISI scores', 'mean ISI scores', 'chronic insomnia', 'PSQI scores', 'ISI and PSQI scores', 'Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242765', 'cui_str': 'Lettuce'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0330464', 'cui_str': 'Viola odorata'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",50.0,0.415055,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"[{'ForeName': 'Zhila', 'Initials': 'Z', 'LastName': 'Taherzadeh', 'Affiliation': 'Targeted Drug Delivery Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khaluyan', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Iranshahy', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Rezaeitalab', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Eshaghi Ghalibaf', 'Affiliation': 'Anesthesiology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Behjat', 'Initials': 'B', 'LastName': 'Javadi', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: javadib@mums.ac.ir.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113116']
1502,32736164,The presence of a caregiver is associated with patient outcomes in patients with Parkinson's disease and atypical parkinsonisms.,"INTRODUCTION


Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver. Although caregivers can play a key role in supporting patients, little is known about how and whether PD patients with and without caregivers differ in terms of physical, cognitive, and mood outcomes. This study explored whether caregiver presence was associated with variations in patient presentation and outcomes in a palliative PD and atypical PD population.
METHODS


Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada. Measures included: MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale.
RESULTS


Of 210 participants, 175 (83%) had a caregiver. Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale. Despite poorer cognitive and motor function, those with caregivers had higher QOL as measured by the Quality of Life in Alzheimer Disease and less spiritual distress. There were no group differences on anxiety, depression, or grief. Caregiver presence moderated the association between lower MoCA score and worse motor symptoms.
CONCLUSION


Findings of the present study highlight the influence of caregiver engagement on PD patient outcomes. These findings have implications for clinical practice and suggest that presence of a caregiver may be an important modifying variable on patient outcomes to examine in future research.",2020,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","['Of 210 participants, 175 (83%) had a caregiver', ""patients with Parkinson's disease and atypical parkinsonisms"", 'Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada', ""Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver""]",[],"['Palliative Performance Scale', 'MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale', 'anxiety, depression, or grief', 'lower MoCA score and worse motor symptoms', 'motor difficulty, lower cognitive scores']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585086', 'cui_str': 'Has a caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4302185', 'cui_str': 'Atypical Parkinsonism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]",[],"[{'cui': 'C4720846', 'cui_str': 'Palliative performance scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",210.0,0.115968,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","[{'ForeName': 'Lindsay Penny', 'Initials': 'LP', 'LastName': 'Prizer', 'Affiliation': 'Division of General Medicine and Geriatrics, Emory University School of Medicine, 6 Executive Park, 1st Floor, Atlanta, GA, 30329, USA. Electronic address: lprizer@emory.edu.'}, {'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Departments of Neurology and Medicine, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Galifianakis', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miyasaki', 'Affiliation': 'Parkinson and Movement Disorders Program, Neuropalliative Care, Department of Medicine, University of Alberta, Canada.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.07.003']
1503,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
1504,32738662,"Reaching reliable change using short, daily, cognitive training exercises delivered on a mobile application: The case of Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions in a subclinical cohort.","BACKGROUND


Relationship Obsessive Compulsive Disorder (ROCD) is a presentation of OCD centering on interpersonal relationships. The aim of this Randomized Control Trial (RCT) was to assess the efficacy of short, game like, daily cognitive interventions delivered via mobile application in reducing subclinical ROCD symptoms and associated phenomena.
METHODS


Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version) were randomized into: immediate-use group (iApp group; n = 25) and delayed-use group (dApp group; n = 25). The iApp group started using the evaluated cognitive-behavioral training application at baseline for 15 days (T0 to T1). The dApp group commenced using the application at T1 for 15 days (T1 to T2). All participants completed questionnaires at baseline (T0), 15 days from baseline (T1), and 30 days from baseline (T2).
RESULTS


Repeated measure MANOVAs showed significant Group (iApp vs. dApp) × Time (T0 vs. T1) interactions. These interactions indicated greater decrease in ROCD symptoms, OCD beliefs and social anxiety symptoms, as well as a greater increase in self-esteem in the iApp group compared to dApp group at T1. Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
LIMITATIONS


Sample size and the use of self-report measures limits the generalizability of the results.
CONCLUSIONS


Short, daily cognitive training interventions delivered via mobile applications may be useful in reducing subclinical ROCD symptoms and associated features. Further testing is needed for clinical populations.",2020,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
",['Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version'],"['immediate-use group (iApp group; n\xa0=\xa025) and delayed-use group (dApp group; n\xa0=\xa025', 'cognitive training exercises delivered on a mobile application']","['subclinical ROCD symptoms', 'Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions', 'ROCD symptoms, OCD beliefs and social anxiety symptoms', 'subclinical ROCD symptoms and associated phenomena', 'self-esteem', 'ROCD symptoms']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0088932', 'cui_str': '1-(diethylaminopropyl)-4-phenylpiperazine'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",,0.0611703,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cerea', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy. Electronic address: silvia.cerea@unipd.it.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ghisi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Gioia', 'Initials': 'G', 'LastName': 'Bottesi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Carraro', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Broggio', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, PO Box 167, Herzliya 46150, Israel. Electronic address: gdoron@idc.ac.il.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.043']
1505,32743968,Crestal Bone Changes and Patient Satisfaction with Single Implant-Retained Mandibular Overdentures with Dalla Bona and Locator Attachments with Immediate Loading Protocols. A Randomized Controlled Clinical Study.,"PURPOSE


There is no enough evidence present on the success of single implant-retained mandibular overdentures (SIMO) with Dalla Bona and Locator attachments. This study aims to compare crestal bone loss and patient satisfaction with SIMO with Dalla Bona and Locator attachment following immediate loading protocols.
MATERIAL AND METHODS


Twelve patients included in Group 1 received immediate SIMO with Dalla Bona attachments, and another twelve patients in Group 2 received immediate SIMO with Locator attachments in the mid symphyseal region. The follow-up was scheduled at 6 and 12 months after implant placement. The patient satisfaction with the denture was evaluated with the visual analog scale (VAS) score. The data obtained were statistically analyzed with the independent student t-test for intergroup comparison and repeated measures of ANOVA followed by Bonferroni's Post hoc analysis for intragroup comparison of mean crestal bone loss at a different time interval.
RESULTS


Ten patients each in both the groups were available for follow-up. Crestal bone loss at 6 months follow-up for Dalla Bona group was 0.42 ± 0.10 mm on the mesial side and 0.43 ± 0.14 mm on the distal side and at 1 year 1.54 ± 0.16 mm on the mesial side and 1.66 ± 0.13 mm on the distal side. The mean crestal bone loss at 6 months follow-up for Locator group was 0.48 ± 0.16 mm on the mesial side and 0.45 ± 0.11 mm on the distal side and at 1 year was 1.71 ± 0.22 mm on mesial side and 1.74 ± 0.28 mm on the distal side. There was difference in bone loss at 6 months (mesial: 0.06 mm, p = 0.327; distal:0.02 mm; p = 0.726) and at 1 year (mesial: 0.17 mm, p = 0.063; distal: 0.08 mm; p = 0.423) in between two groups but the difference was statistically insignificant. There was a significant difference found in the VAS score for patient satisfaction with SIMO with Dalla Bona attachments and Locator attachments at 6 months (54.2 vs. 51.8, p = 0.005) and 1 year (60.6 vs. 55.2, p = 0.005).
CONCLUSIONS


Patient satisfaction with SIMO with Dalla Bona attachments was higher during the follow-up. SIMO with Dalla Bona attachments had less crestal bone loss and less prosthetic complications when compared to Locator attachments, although the difference in the bone loss was statistically insignificant.",2020,"There was difference in bone loss at 6 months (mesial: 0.06 mm, p = 0.327; distal:0.02 mm; p = 0.726) and at 1 year (mesial: 0.17 mm, p = 0.063; distal: 0.08 mm; p = 0.423) in between two groups but the difference was statistically insignificant.",[],"['immediate SIMO with Dalla Bona attachments, and another twelve patients in Group 2 received immediate SIMO with Locator attachments']","['VAS score', 'visual analog scale (VAS) score', 'Crestal Bone Changes and Patient Satisfaction', 'bone loss', 'crestal bone loss', 'prosthetic complications', 'Crestal bone loss', 'crestal bone loss and patient satisfaction with SIMO with Dalla Bona and Locator attachment', 'mean crestal bone loss']",[],"[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",12.0,0.0435881,"There was difference in bone loss at 6 months (mesial: 0.06 mm, p = 0.327; distal:0.02 mm; p = 0.726) and at 1 year (mesial: 0.17 mm, p = 0.063; distal: 0.08 mm; p = 0.423) in between two groups but the difference was statistically insignificant.","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Nischal', 'Affiliation': 'Department of Prosthodontics, Rajarajeswari Dental College and Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Mishra', 'Affiliation': 'Department of Prosthodontics, Peoples College of Dental Sciences and Research Centre, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Chowdhary', 'Affiliation': 'Department of Prosthodontics, Rajarajeswari Dental College and Hospital, Bengaluru, Karnataka, India.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13230']
1506,32744134,A Simple Goal Elicitation Tool Improves Shared Decision Making in Outpatient Orthopedic Surgery: A Randomized Controlled Trial.,"Introduction . Shared decision making involves educating the patient, eliciting their goals, and collaborating on a decision for treatment. Goal elicitation is challenging for physicians as previous research has shown that patients do not bring up their goals on their own. Failure to properly elicit patient goals leads to increased patient misconceptions and decisional conflict. We performed a randomized controlled trial to test the efficacy of a simple goal elicitation tool in improving patient involvement in decision making.  Methods . We conducted a randomized, single-blind study of new patients presenting to a single, outpatient surgical center. Prior to their consultation, the intervention group received a demographics questionnaire and a goal elicitation worksheet. The control group received a demographics questionnaire only. After the consultation, both groups were asked to complete the Perceived Involvement in Care Scale (PICS) survey. We compared the mean PICS scores for the intervention and control groups using a nonparametric Mann-Whitney Wilcoxon test. Secondary analysis included a qualitative content analysis of the patient goals.  Results . Our final cohort consisted of 96 patients (46 intervention, 50 control). Both groups were similar in terms of demographic composition. The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27],  P  < 0.01). Thirty-nine percent of patient goals were focused on receiving a diagnosis or treatment, while 21% of patients wanted to receive education regarding their illness or their treatment options.  Discussion . A single-step goal elicitation tool was effective in improving patient-perceived involvement in their care. This tool can be efficiently implemented in both academic and nonacademic settings.",2020,"The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27],  P  < 0.01).","['96 patients (46 intervention, 50 control', 'Outpatient Orthopedic Surgery', 'new patients presenting to a single, outpatient surgical center']","['demographics questionnaire and a goal elicitation worksheet', 'demographics questionnaire only']","['mean PICS scores', 'qualitative content analysis of the patient goals', 'mean (SD) PICS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroidopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",96.0,0.0671466,"The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27],  P  < 0.01).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mertz', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Romil F', 'Initials': 'RF', 'LastName': 'Shah', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Safran', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Palanca', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Serena S', 'Initials': 'SS', 'LastName': 'Hu', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gardner', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Derek F', 'Initials': 'DF', 'LastName': 'Amanatullah', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20943520']
1507,32739331,Which brand should be more nervous about nutritional information disclosure: McDonald's or Subway?,"This study examines the health halo and horn effects in the context of two fast food brands commonly associated with healthy and unhealthy food (i.e., Subway and McDonald's). Health halo is consumers' tendency to overestimate the healthiness of certain food categories or items based on a single claim, whereas health horn is the tendency to underestimate it. Specifically, we investigated the moderating effects of nutritional information disclosure and dietary restraint on consumers' behavioral intentions. Two items from the McDonald's and Subway menus each served as stimuli. They represented health halo confirmation (Roast Chicken sandwich) or disconfirmation (Italian Spicy sandwich) and health horn confirmation (Big Mac burger) or disconfirmation (McSpicy Cajun Burger). This study employed a 2 (nutritional information: present vs. absent) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) mixed factorial design. Participants were randomly assigned to one of two experimental conditions (nutritional information: present vs. absent) and presented with all four menu items. There was a decrease in behavioral intentions toward all menu items except the one representing health horn disconfirmation. In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich). The findings not only delineate the different practices companies adopt but also underscore the importance of nutritional information disclosure in helping consumers make healthier food choices.",2020,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[""consumers' behavioral intentions""]","[""absent)\u202f×\u202f4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters"", 'nutritional information disclosure and dietary restraint', ""health halo or horn associated with Subway or McDonald's menu items""]",['behavioral intentions'],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0019939', 'cui_str': 'Horns'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0524709', 'cui_str': 'Subways'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0167676,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[{'ForeName': 'Meeyoung', 'Initials': 'M', 'LastName': 'Joe', 'Affiliation': 'Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 505, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: cookie22@yonsei.ac.kr.'}, {'ForeName': 'Seoki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Hospitality Management, The Pennsylvania State University, 217 Mateer Building University Park, PA, 16802, USA. Electronic address: leeseoki@psu.edu.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Ham', 'Affiliation': 'Dept. of Food & Nutrition, Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 510, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: sham2@yonsei.ac.kr.'}]",Appetite,['10.1016/j.appet.2020.104805']
1508,32739460,The effect of moderate-intensity aerobic training on pulmonary function and estrogen receptor-alpha gene in postmenopausal women with vitamin D deficiency: A randomized control trial.,"BACKGROUND


The impact of aerobic training on pulmonary function by modulating gene expression of estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D) in postmenopausal women (PMW) with Vit D deficiency is uncertain.
OBJECTIVE


The purpose of this study was to examine the effect of 12 weeks of moderate-intensity aerobic training on pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D in PMW with Vit D deficiency.
METHODS


Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs) were randomized to exercise (EX, n = 15) and control (C, n = 14) groups. The EX group performed moderate-intensity aerobic training for 12 weeks (50-60 min/day, 3 days/week at 65-70% of maximal heart rate reserve), but the C group participated in no intervention and maintain their normal lifestyle during 12 weeks. The pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D were measured at baseline and week-12.
RESULTS


After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
CONCLUSIONS


The results suggested that 12 weeks of moderate-intensity aerobic training increased lymphocyte ERα gene expression as well as serum Vit D in sedentary PMW with Vit D deficiency although pulmonary function was not improved.",2020,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","['postmenopausal women with vitamin D deficiency', 'postmenopausal women (PMW) with Vit D deficiency', 'Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs']","['aerobic exercise intervention', 'aerobic training', 'C group participated in no intervention and maintain their normal lifestyle', 'exercise (EX', 'moderate-intensity aerobic training']","['pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D', 'estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D', 'pulmonary function parameters and sex hormones (17β-estradiol and progesterone', 'lymphocyte ERα gene expression', 'serum Vit D', 'pulmonary function and estrogen receptor-alpha gene', 'pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptors alpha'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",29.0,0.0296952,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran. Electronic address: ba.tartibian@gmail.com.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: rahmati_bio@yahoo.com.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: r.afsargarebag@gmail.com.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: Z.sheikhlou@gmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103510']
1509,32739493,Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial.,"BACKGROUND


Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system.
METHODS


A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania. Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians.
DISCUSSION


This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.",2020,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","['Patients with advanced cancer and their caregivers are invited to enroll', 'patients with advanced cancer']","['person advance care planning (ACP) discussions versus web-based ACP', 'person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool']","['patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs', 'ACP effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.133077,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","[{'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Resick', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: jmr58@pitt.edu.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: rabob@pitt.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, USA; San Francisco Veterans Affairs Health Care System, SFVAMC 4150 Clement Street, #151R, San Francisco, CA 94121, USA. Electronic address: Rebecca.Sudore@ucsf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., 1304 Broad Street, Durham, NC 27705, USA. Electronic address: dfarrell@peopledesigns.com.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Belin', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: belin@pitt.edu.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh School of Medicine, 200 Meyran Avenue, Suite 300, Pittsburgh, PA 15213, USA. Electronic address: ada62@pitt.edu.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Division of Nursing Research and Education, Department of Population Sciences, City of Hope Medical Center, 1500 Duarte Road, Duarte, CA 91010, USA. Electronic address: BFerrell@coh.org.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Hammes', 'Affiliation': 'Respecting Choices, A Division of C-TAC Innovations, PO Box 258, Oregon, WI 53575-0258, USA. Electronic address: bhammes@respectingchoices.org.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology and Cancer Therapeutics Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: chue2@upmc.edu.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 600 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15213, USA. Electronic address: douglas.white@pitt.edu.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Rak', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 3520 Fifth Ave, Suite100, Pittsburgh, PA 15213, USA. Electronic address: kjr8@pitt.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: yas28@pitt.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106071']
1510,32739494,Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial.,"BACKGROUND


Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population.
METHODS


At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years.
RESULTS


Nearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use.
CONCLUSIONS


Personal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).",2020,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"['healthy older individuals to 100\u202fmg', 'Eligible participants were healthy, free of major diseases and expected to survive 5\u202fyears', 'healthy older ASPREE participants', 'healthy older people enrolling', 'At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n\u202f=\u202f16,703; U.S., n\u202f=\u202f2411', 'uniquely healthy older population']","['ASPirin', 'aspirin or placebo']","['Cancer history and risk factors', 'Prevalence of prostate and breast cancer history', 'Cancer prevalence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",19114.0,0.463069,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"[{'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Suzanne.orchard@monash.edu.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Jessica.lockery@monash.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, University of Melbourne,1G Royal Parade, Parkville, Victoria 3052, Australia. Electronic address: Peter.gibbs@petermac.org.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Galhina.polekhina@monash.edu.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Rory.wolfe@monash.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.zalcberg@monash.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Andrew.haydon@monash.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.mcneil@monash.edu.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St (Private Bag 23), Hobart 7000, Tasmania, Australia. Electronic address: Mark.nelson@utas.edu.au.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Kent Street, Bentley, Perth 6102, Western Australia, Australia. Electronic address: Christpher.reid@curtin.edu.au.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA. Electronic address: bkirpach@bermancenter.org.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA; Division of Geriatrics, Department of Medicine, Hennepin Healthcare and University of Minnesota, East River Parkway, Minneapolis 55455, Minnesota, USA. Electronic address: AMurray@bermancenter.org.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Robyn.woods@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106095']
1511,32739495,Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis.,"BACKGROUND/AIMS


Despite high mortality of alcohol-associated hepatitis, there has been limited advancement in treatment strategies. Defeat Alcoholic Steatohepatitis (DASH) is a multicenter, randomized, double-blind controlled trial whose primary objective was to evaluate the safety and efficacy of a novel combination of 3 drugs targeting different perturbations in AH.
METHODS


Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score ≥ 20 stratified by MELD scores (20-25 and ≥ 26) and randomized to a combination of an interleukin receptor 1 antagonist, Anakinra(100 mg daily for 14 days) to suppress acute inflammation, pentoxifylline (400 mg three times a day for 28 days) to prevent hepatorenal syndrome, and zinc sulfate (220 mg orally once daily for 6 months) or the standard of care therapy including methylprednisolone 32 mg orally once daily for 28 days. The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
RESULTS


Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6 ± 3.2 (20.0-35.0) in the investigational arm and 25.8 ± 4.5 (20.0-40.0) in the standard of care arm. Causes of screen failures included not meeting eligibility criteria (n = 347), declining to participate (n = 39), and other reasons (n = 10).
CONCLUSIONS


Data from the DASH consortium studies will determine if a combination of drugs targeting multiple mechanisms of injury in the severe AH will improve clinical outcomes.",2020,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","['Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6\u202f±\u202f3.2 (20.0-35.0) in the investigational arm and 25.8\u202f±\u202f4.5 (20.0-40.0) in the standard of care arm', 'Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score\u202f≥']","['interleukin receptor 1 antagonist, Anakinra(100\u202fmg daily for 14\u202fdays) to suppress acute inflammation, pentoxifylline', 'zinc sulfate (220\u202fmg orally once daily for 6\u202fmonths) or the standard of care therapy including methylprednisolone']","['safety and efficacy', 'unadjusted log-rank test of the Kaplan-Meier survival estimates']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0206553', 'cui_str': 'Interleukin Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0333361', 'cui_str': 'Acute inflammation'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",104.0,0.725088,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","[{'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Cleveland Clinic, USA. Electronic address: dasaras@ccf.org.'}, {'ForeName': 'Mack C', 'Initials': 'MC', 'LastName': 'Mitchell', 'Affiliation': 'University of Texas at Southwestern University, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'University of Massachusetts, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'University of Louisville, USA.'}, {'ForeName': 'Gyongyi', 'Initials': 'G', 'LastName': 'Szabo', 'Affiliation': 'Harvard Medical School & Beth Israel Deaconess Medical Center, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Nagy', 'Affiliation': 'Cleveland Clinic, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Radaeva', 'Affiliation': 'National Institute of Alcohol Abuse and Alcoholism, USA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Cleveland Clinic, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106094']
1512,32739537,Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial.,"BACKGROUND


Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued.
METHODS


The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure.
CONCLUSIONS


The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).",2020,The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).,"['acute coronary syndrome patients with multivessel disease', 'patients presenting with acute coronary syndrome and multivessel disease', 'patients with an acute coronary syndrome and multivessel disease', '1,525 patients 1:1 to', 'Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain']","['immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm', 'sirolimus-eluting biodegradable polymer-coated stents']","['composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1525.0,0.0551991,The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).,"[{'ForeName': 'Wijnand K', 'Initials': 'WK', 'LastName': 'den Dekker', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands. Electronic address: w.dendekker@erasmusmc.nl.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': 'Cardiovascular institute, Hospital Clinic University of Barcelona, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Rutger J', 'Initials': 'RJ', 'LastName': 'van Bommel', 'Affiliation': 'Department of Cardiology, Tergooi Blaricum, Blaricum, the Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Daemen', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vrolix', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Cummins', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Mattie J', 'Initials': 'MJ', 'LastName': 'Lenzen', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.006']
1513,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1514,32739652,"Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.","BACKGROUND


Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear.
STUDY DESIGN


The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks (""bi-risk""). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization.
CONCLUSIONS


OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.",2020,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","['7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS', 'patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention', 'acute coronary syndrome patients with both high bleeding and ischemic risk', 'patients at special risk', 'ACS patients with both high bleeding and high ischemic risks (""bi-risk']","['clopidogrel alone versus clopidogrel plus aspirin', 'aspirin and a P2Y12 inhibitor', 'aspirin monotherapy', 'aspirin and clopidogrel', 'clopidogrel monotherapy or aspirin plus clopidogrel', 'placebo']","['major adverse cardiac and cerebral events', 'composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization', 'bleeding events', 'Bleeding Academic Research Consortium type 2, 3, or 5 bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",7700.0,0.0625651,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shubing', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital of Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Nanjing First Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.07.005']
1515,32739670,"The effects of a transitional care program on discharge readiness, transitional care quality, health services utilization and satisfaction among Chinese kidney transplant recipients: A randomized controlled trial.","BACKGROUND


Kidney transplantation is the major treatment for end-stage renal disease (ESRD). However, kidney transplant recipients (KTRs) face severe challenges during the transition period from hospital discharge to home, increasing the risk of early hospital readmission (EHR) and affecting patient safety. Nevertheless, knowledge of effective transitional care for KTRs is limited in China.
OBJECTIVE


To evaluate the effectiveness of an innovative transitional care program in improving discharge readiness, transitional care quality, health services utilization and patient satisfaction among KTRs in China.
DESIGN


A prospective randomized controlled trial.
SETTINGS AND PARTICIPANTS


Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China.
METHODS


A total of 220 eligible patients were recruited and randomly assigned to the intervention and control groups. Participants in the intervention group received a transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge. The control group received routine care of comparable length and follow-up contact. A trained research assistant collected all patients' baseline data on admission (T0), evaluated the discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge. Intervention effects were analyzed using independent samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test.
RESULTS


Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
CONCLUSIONS


This study provides evidence that an innovative transitional care program is effective in promoting KTRs' discharge readiness, transitional care quality, reducing hospital readmission and emergency room visits, and improving their satisfaction with transitional care services.
TRIAL REGISTRATION


Clinical Trials ChiCTR1800014971.",2020,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","['A total of 220 eligible patients', 'KTRs in China', 'Chinese kidney transplant recipients', 'Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China']","['transitional care program', 'transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge', 'routine care of comparable length and follow-up contact', 'innovative transitional care program']","['discharge readiness', ""discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge"", 'lower emergency room visit rate', 'lower readmission rate', 'discharge readiness, transitional care quality, health services utilization and satisfaction', 'discharge readiness, transitional care quality, health services utilization and patient satisfaction', 'risk of early hospital readmission (EHR) and affecting patient safety', 'transitional care quality', ""samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012622', 'cui_str': 'Discharge planning'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}]",220.0,0.0555818,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","[{'ForeName': 'Rujun', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Emergency Department, Affiliated Hospital of Zunyi Medical University, Zunyi Medical University, Zunyi 563000, Guizhou, China; School of Nursing, Zunyi Medical University, Zunyi 563000, Guizhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Gu', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Qiling', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'KaiZhi', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Hemodialysis Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Turun', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaolian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China. Electronic address: jiangxiaolianhl@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103700']
1516,32739671,Effects and mediating mechanisms of a structured limbs-exercise program on general cognitive function in older adults with mild cognitive impairment: A randomized controlled trial.,"BACKGROUND


Exercise is known to prevent cognitive decline. Sleep quality and depression symptoms, which are associated with processing speed, are considered as common mediators in the exercise-cognition putative model. However, these mediating mechanisms have not been empirically tested in an intervention study.
OBJECTIVE


The aim of this study was to evaluate the effects of a structured limbs-exercise program on general cognitive function, and to test the mediating effects and mediating pathways of depressive symptoms, sleep quality and processing speed in the relationship of exercise-induced cognitive benefits.
DESIGN


A two-arm and assessor-blinded randomized controlled trial.
SETTINGS AND PARTICIPANTS


Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China.
METHODS


Participants (N=116) were randomly allocated to one of the two arms: (1) a 24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60 min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60 min /session for the following 12 weeks) or (2) health promotion classes alone. Measures of depressive symptoms, sleep quality, processing speed, and general cognitive function were collected at baseline, 12-week, and 24-week. Multivariate analysis of variance and structural equation modeling was used to test the effectiveness and mechanisms of structured limbs-exercise-induced cognitive improvement respectively.
RESULTS


The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group. The results from the goodness-of-fit indices of structural equation modeling show as following: (1) The effect of structured limbs-exercise program on cognitive function was partially mediated by depressive symptoms, sleep quality, and processing speed, with 69.22% of joint mediation proportion; (2) Relative to the combined Z values of depressive symptoms and processing speed, sleep quality was more strongly related to cognitive function in the structured limbs-exercise program (Z= 9.294, p<0.01); (3) Processing speed was affected by depressive symptoms, sleep quality, and in turn, yielding a significant effect on cognitive function; and (4) Five potential mediating pathways for improvement in general cognitive function in the structured limbs-exercise intervention were identified.
CONCLUSION


This study shows that this exercise program can maintain general cognitive function for older adults with mild cognitive impairment. Mediating variables include depressive symptoms, sleep quality and processing speed. Future research should continue to incorporate path-oriented intervention strategies in the exercise intervention to maximize improvements in cognitive function. Registration number: ChiCTR1800016299.",2020,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","['Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China', 'Participants (N=116', 'older adults with mild cognitive impairment']","['exercise program', '24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60\xa0min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60\xa0min /session for the following 12 weeks) or (2) health promotion classes alone', 'structured limbs-exercise program']","['general cognitive function', 'depressive symptoms, sleep quality, and processing speed', 'depressive symptoms, sleep quality', 'depressive symptoms and processing speed, sleep quality', 'cognitive function', 'depressive symptoms, sleep quality, processing speed, and general cognitive function', 'depressive symptoms, sleep quality and processing speed', 'Sleep quality and depression symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",116.0,0.141098,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: aring2000@163.com.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY 10010, USA. Electronic address: bei.wu@nyu.edu.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'AdventHealth Whole-Person Research, Orlando, FL 32804, USA. Electronic address: Hong.Tao@AdventHealth.com.'}, {'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Chai', 'Affiliation': 'School of Nursing, Chifeng University, Chifeng, Inner Mongolia 024000, China. Electronic address: 151606873@qq.com.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 17858368692@163.com.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Zhen', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: zhenxueting1029@163.com.'}, {'ForeName': 'Xianglian', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 18777119676@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103706']
1517,32739704,Aerobic exercise or stretching as add-on to inpatient treatment of depression: Similar antidepressant effects on depressive symptoms and larger effects on working memory for aerobic exercise alone.,"BACKGROUND


Aerobic exercise (AE) has positive effects on symptom severity and cognitive symptoms of depression. Since data on AE as add-on to inpatient treatment in depression is still scarce, we conducted this double-blind randomized controlled study.
METHODS


Patients aged between 18 and 60 years were recruited into the study if Hamilton Depression Rating Scale 17 (HDRS-17) score was >16. Participants were randomly assigned to either AE or basic stretching activities (control), which took place 3x/week for 6 weeks. Primary outcome was depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI). Further physiological and psychological variables and cognitive performance were assessed as secondary outcomes.
RESULTS


Forty-two patients were included in the analysis (exercise: n = 22; control: n = 20). Regardless of group allocation, we found a significant short-term time effect for symptom-severity (HDRS17: p<0.001, η²=0.70; BDI: p<0.001, η²=0.51), mental toughness (p<0.001, η²=0.32), physical self-description endurance score (p = 0.013, η²=0.16), cognitive flexibility (p = 0.013, η²=0.14), and body mass index (BMI) (p = 0.006, η²=0.19). Working memory showed a significant time by group interaction in favor of AE (p = 0.043, η²=0.10). Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period. Finally, self-reported physical activity increased significantly from baseline to follow-up (p = 0.014, η²=0.15).
LIMITATIONS


The sample-size is rather small. The control intervention might have been too active as to find a time by group interaction for symptom severity.
CONCLUSIONS


AE was associated with comparably large depression alleviation vs. stretching and with add-on benefits on working memory.",2020,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","['Forty-two patients were included in the analysis (exercise: n\xa0=\xa022; control: n\xa0=\xa020', 'Patients aged between 18 and 60 years']","['Aerobic exercise or stretching', 'Aerobic exercise (AE', 'AE or basic stretching activities (control', 'aerobic exercise alone']","['mental toughness', 'depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI', 'physical activity', 'symptom severity, mental toughness and BMI', 'physical self-description endurance score', 'Hamilton Depression Rating Scale 17 (HDRS-17) score', 'cognitive flexibility', 'body mass index (BMI']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",42.0,0.225194,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Imboden', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland; Private Clinic Wyss, Muenchenbuchsee, Switzerland. Electronic address: christian.imboden@pkwyss.ch.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland; Private Clinic Sonnenhalde, Riehen, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hatzinger', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.052']
1518,32739716,The comparison of access to an eHealth resource to current practice on mother and co-parent teamwork and breastfeeding rates: A randomized controlled trial.,"BACKGROUND


Breastfeeding rates are suboptimal, putting mothers and their infants' health at risk. One modifiable risk factor amenable to intervention is partner support. Having women work as a team with their co-parents to meet their breastfeeding goals has been found to improve breastfeeding outcomes. eHealth resources have been found to be accessible and feasible ways to provide breastfeeding education yet, the best way to design breastfeeding interventions for mothers and their co-parents is not known.
OBJECTIVES


To compare two study conditions to determine: (1) which way is more effective to provide breastfeeding education to women and their co-parents on increasing breastfeeding rates and associated secondary outcomes, such as breastfeeding knowledge, attitude, self-efficacy and overcoming challenges; (2) the difference in co-parenting and partner support between the study groups; (3) how parents in both groups preferred to access breastfeeding information; and (4) the groups' satisfaction with the eHealth resource that was provided.
DESIGN


This study used a randomized controlled trial design (Clinicaltrials.org #NCT03492411). Participants were randomly allocated to study groups with concealed opaque envelopes by a blinded research assistant. Participants in Study Condition #1 (SC1) accessed a previously created, online e-Health resource, in addition to other generally available resources they could access in the community; participants in Study Condition #2 (SC2) accessed only the generally available resources.
SETTING


Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada.
PARTICIPANTS


Expectant women (n = 113) and their co-parents (n = 104) were enrolled.
METHODS


After eligibility was determined, consents obtained and baseline surveys completed, group allocation was conducted. SC1 had a virtual meeting with a research assistant to review the eHealth resource. Weekly emails were sent to all participants for 6 weeks as reminders. Follow-up data were electronically collected from mothers and co-parents at 2 weeks post enrollment and 4, 12, 26 and 52-weeks postpartum.
RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different. High scores were found in both groups in secondary outcome measures. Generally available breastfeeding resources were used in both groups with websites being used often and rated as most helpful. SC1 rated the eHealth resource provided to them highly.
CONCLUSION


The findings suggest both mothers and their co-parents should be targeted in breastfeeding education and web-based resources designed to meet their needs.",2020,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","['Expectant women (n\xa0=\xa0113) and their co-parents (n\xa0=\xa0104) were enrolled', 'Participants in Study Condition', ""Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada""]",[],['Breastfeeding rates'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}]",104.0,0.0703829,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Abbass-Dick', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada. Electronic address: jennifer.abbassdick@ontariotechu.ca.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Newport', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Fangli', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Godfrey', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Goodman', 'Affiliation': 'Faculty of Business and Information Technology, Ontario Tech University.'}]",Midwifery,['10.1016/j.midw.2020.102812']
1519,32739974,"New evidence on prognostic features, prevention and treatment of congenital Cytomegalovirus infection.","PURPOSE OF REVIEW


Congenital Cytomegalovirus (CMV) infection remains a major cause of lifelong disability, with no systematic screening implemented in pregnancy or the postnatal period. In this review article, we outline the preventive strategies, antenatal prognostic features and experimental therapies as well as evidence of efficacy from recent trials.
RECENT FINDINGS


A recent randomized, double blinded, placebo-controlled study investigated the efficacy of Valaciclovir in women contracting primary CMV in the periconception period or first trimester. They concluded that Valaciclovir at a dose of 8 g/day is effective in reducing the rate of foetal CMV infection following early maternal primary infection. Administration of CMV hyperimmune globulin (HIG) was investigated in a recent randomized double-masked controlled trial. This study concluded that CMV HIG was ineffective at reducing the risk of congenital CMV among women with primary CMV in early pregnancy.
SUMMARY


Congenital CMV infection remains a significant cause of disability. There is currently no vaccine available, with the best preventive strategy being patient education on transmission as well as hygiene measures to reduce risk of exposure. Experimental therapies have been investigated in recent years and there is evidence supporting the use of Valaciclovir. Data for the efficacy of CMV HIG remains inconsistent and administration is currently limited to clinical trial settings.",2020,"This study concluded that CMV HIG was ineffective at reducing the risk of congenital CMV among women with primary CMV in early pregnancy.
","['women with primary CMV in early pregnancy', 'women contracting primary CMV in the periconception period or first trimester']","['Valaciclovir', 'CMV hyperimmune globulin (HIG', 'CMV HIG', 'placebo']","['risk of congenital CMV', 'rate of foetal CMV infection']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}]","[{'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}]",,0.471966,"This study concluded that CMV HIG was ineffective at reducing the risk of congenital CMV among women with primary CMV in early pregnancy.
","[{'ForeName': 'Mercede', 'Initials': 'M', 'LastName': 'Sebghati', 'Affiliation': ""Fetal Medicine Unit, St George's University Hospitals.""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Fetal Medicine Unit, St George's University Hospitals.""}]",Current opinion in obstetrics & gynecology,['10.1097/GCO.0000000000000651']
1520,32740286,"Ergogenic Effects of 8 Days of Sceletium Tortuosum Supplementation on Mood, Visual Tracking, and Reaction in Recreationally Trained Men and Women.","Hoffman, JR, Marcus, I, Dubnov-Raz, G, and Gepner, Y. Ergogenic effects of 8 days of Sceletium tortuosum supplementation on mood, visual tracking, and reaction in recreationally trained men and women. J Strength Cond Res 34(9): 2476-2481, 2020-Sceletium tortuosum (ST) is a South African plant that has been reported to promote a sense of well-being in healthy individuals and used in treating people with anxiety, stress, or depression. These studies have been conducted in middle-aged and older adults, but no investigations have been performed in a healthy, young adult population. Thus, the purpose of this study was to examine the effect of 8 days of ST extract (25-mg) supplementation on changes in reactive agility, visual tracking, and mood. Sixty recreationally trained men (n = 48) and women (n = 12), between 20 and 35 years, were randomly assigned to 1 of 2 groups: ST or placebo (PL). Subjects were tested on 2 occasions: before supplementation and 2-hours after supplementation on day 8. Subjects completed a subjective questionnaire to assess alertness and energy using a visual analog scale (VAS). In addition, subjects completed the Profile of Mood States questionnaire and performed reactive agility and visual tracking assessments. Significant improvements were noted for ST in complex reactive performance that required subjects to respond to repeated visual stimuli with a cognitive load compared with PL. However, no significant changes were noted between the groups in either VAS or total mood score. In addition, no differences were observed in simple reaction assessments. The results of this study demonstrate an ergogenic benefit in complex reactive tasks that include a cognitive load. However, in this subject population studied, no benefits in mood were observed.",2020,Significant improvements were noted for ST in complex reactive performance that required subjects to respond to repeated visual stimuli with a cognitive load compared with PL.,"['middle-aged and older adults', 'Sixty recreationally trained men (n = 48) and women (n = 12), between 20 and 35 years', 'Recreationally Trained Men and Women']","['J Strength Cond Res XX(X', '2020-Sceletium tortuosum (ST', 'ST extract (25-mg) supplementation', 'Sceletium Tortuosum Supplementation', 'ST or placebo (PL']","['VAS or total mood score', 'mood, visual tracking, and reaction', 'subjective questionnaire to assess alertness and energy using a visual analog scale (VAS', 'reactive agility, visual tracking, and mood', 'simple reaction assessments', 'Profile of Mood States questionnaire and performed reactive agility and visual tracking assessments', 'Mood, Visual Tracking, and Reaction']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",60.0,0.0716422,Significant improvements were noted for ST in complex reactive performance that required subjects to respond to repeated visual stimuli with a cognitive load compared with PL.,"[{'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Hoffman', 'Affiliation': 'Department of Molecular Biology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Markus', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine and Sylvan Adams Sports Institute, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Dubnov-Raz', 'Affiliation': ""The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine and Sylvan Adams Sports Institute, Tel Aviv University, Tel Aviv, Israel.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003693']
1521,32740321,Minimum effective volume of 0.5% ropivacaine for ultrasound-guided costoclavicular brachial plexus block: A dose finding study.,"BACKGROUND


Costoclavicular brachial plexus block (CC-BPB) is a relatively new regional anaesthetic technique and there are no data on the minimum effective volume 90 (MEV90) of 0.5% ropivacaine required for an ultrasound-guided CC-BPB.
OBJECTIVE


To determine the MEV90 of 0.5% ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB.
DESIGN


Prospective up-down sequential allocation study design.
SETTING


University teaching hospital in Hong Kong from March 2016 to December 2017.
PATIENTS


Forty-eight, ASA physical status I to III patients, aged 70 years or less and scheduled for elective forearm or hand surgery under an ultrasound-guided CC-BPB, were recruited.
INTERVENTION


Ultrasound-guided CC-BPB was performed with the assigned volume of 0.5% ropivacaine. The Dixon 'up-and-down' sequential allocation method using the biased coin design was used to determine the MEV90 of 0.5% ropivacaine. The assigned volume of ropivacaine was based on the outcome of the previous patient. After a block failure the next patient received a volume increase of 2 ml. If the block was a success, the next patient was allocated, with a probability of b = 0.11, to receive 2 ml less, or, with a probability of 1 - b = 0.89, the same volume.
MAIN OUTCOME MEASURES


A successful block was defined as a minimum score of 14 of 16 points, using a composite sensory and motor block score at 45 min after the injection. The study was stopped when 45 successful blocks were achieved. MEV90 with 95% confidence interval was calculated using the centred isotonic regression for point and interval dose response studies.
RESULTS


The MEV90 of 0.5% ropivacaine for ultrasound-guided CC-BPB was 20.9 (95% confidence interval, 20.7 to 21.8) ml. The mean ± SD time to readiness for surgery was 31.4 ± 12.60 min.
CONCLUSION


The MEV90 of 0.5% ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB is 20.9 ml.
CLINICAL TRIAL REGISTRATION


The trial was registered with the Chinese Clinical Trials Registry (www.chictr.org.cn, ChiCTR-IOR-15007515, principal investigator: Manoj Kumar Karmakar, date of registration: 4 December 2015).
CLINICAL TRIAL NUMBER AND REGISTRY URL


ChiCTR-IOR-15007515, Chinese Clinical Trials Registry (www.chictr.org.cn).",2020,"The MEV90 of 0.5% w/v ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB is 20.9 ml.
","['III patients, aged 70 years or less and scheduled for elective forearm or hand surgery under an ultrasound-guided CC-BPB, were recruited', 'University teaching hospital in Hong Kong from March 2016 to December 2017', 'Forty-eight, ASA physical status']","['ropivacaine', 'Costoclavicular brachial plexus block (CC-BPB']",['mean\u200a±\u200aSD time to readiness'],"[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1608675', 'cui_str': '4-iodo-N-(4-(4-(2-methoxyphenyl)-piperazin-1-yl)butyl)-benzamide'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C1608675', 'cui_str': '4-iodo-N-(4-(4-(2-methoxyphenyl)-piperazin-1-yl)butyl)-benzamide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",45.0,0.0788485,"The MEV90 of 0.5% w/v ropivacaine required to produce surgical anaesthesia with an ultrasound-guided CC-BPB is 20.9 ml.
","[{'ForeName': 'Ming H', 'Initials': 'MH', 'LastName': 'Wong', 'Affiliation': 'From the Department of Anaesthesia & Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China (MHW, MKK, LYHM, BS, WS).'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Karmakar', 'Affiliation': ''}, {'ForeName': 'Louis Y H', 'Initials': 'LYH', 'LastName': 'Mok', 'Affiliation': ''}, {'ForeName': 'Banchobporn', 'Initials': 'B', 'LastName': 'Songthamwat', 'Affiliation': ''}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Samy', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001287']
1522,32740578,Abdominoplasty with Scarpa Fascia Preservation: Randomized Controlled Trial with Assessment of Scar Quality and Cutaneous Sensibility.,"BACKGROUND


Scarpa fascia preservation during abdominoplasty has been shown to reduce complications associated with the traditional technique. As an extension of a previously published randomized controlled trial, this study aims to clarify whether preservation of Scarpa fascia during abdominoplasty has an influence on scar quality or sensibility recovery.
METHODS


This was a single-center clinical trial, involving 160 patients randomly assigned to one of two surgical procedures: classic full abdominoplasty (group A) and abdominoplasty with preservation of Scarpa fascia (group B). Patients were later convoked to assess scar quality and abdominal cutaneous sensibility. Scar quality was evaluated through the Patient and Observer Scar Assessment Scale. Cutaneous sensibility was measured on the upper and lower abdomen, using light touch, Semmes-Weinstein testing (5.07/10-g monofilament), and a 25-gauge needle.
RESULTS


A total of 99 patients (group A, 54 patients; group B, 45 patients) responded to contact, with a mean follow-up time of 44 months. Concerning scar quality, Patient and Observer Scar Assessment Scale scores were similar between groups. On the upper abdomen, there was a statistically significant difference between groups on cutaneous sensibility, on the examination with the Semmes-Weinstein 5.07/10-g monofilament (group A, 79.6 percent; group B, 93.3 percent; p = 0.046) and pain (group A, 90.7 percent; group B, 100 percent; p = 0.044). No statistically significant differences were found between groups on the lower abdomen. A considerable proportion of patients (two-thirds) still presented sensibility alterations in the subumbilical area 3½ years after abdominoplasty.
CONCLUSION


Scarpa fascia preservation during abdominoplasty does not influence scar quality, but it improves sensibility recovery in the supraumbilical area.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"On the upper abdomen, there was a statistically significant difference between groups on cutaneous sensibility, on the examination with the Semmes-Weinstein 5.07/10-g monofilament (group A, 79.6 percent; group B, 93.3 percent; p = 0.046) and pain (group A, 90.7 percent; group B, 100 percent; p = 0.044).","['99 patients (group A, 54 patients; group B, 45 patients', '160 patients randomly assigned to one of two surgical procedures']","['classic full abdominoplasty (group A) and abdominoplasty with preservation of Scarpa fascia', 'Abdominoplasty with Scarpa Fascia Preservation']","['Patient and Observer Scar Assessment Scale', 'Cutaneous sensibility', 'Concerning scar quality, Patient and Observer Scar Assessment Scale scores', 'Scar quality', 'sensibility recovery', 'scar quality or sensibility recovery', 'scar quality', 'pain', 'scar quality and abdominal cutaneous sensibility', 'Scar Quality and Cutaneous Sensibility', 'cutaneous sensibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]",160.0,0.0753179,"On the upper abdomen, there was a statistically significant difference between groups on cutaneous sensibility, on the examination with the Semmes-Weinstein 5.07/10-g monofilament (group A, 79.6 percent; group B, 93.3 percent; p = 0.046) and pain (group A, 90.7 percent; group B, 100 percent; p = 0.044).","[{'ForeName': 'Catarina S', 'Initials': 'CS', 'LastName': 'Novais', 'Affiliation': 'Porto, Portugal From Porto University Medical School; the Department of Plastic, Aesthetic, and Reconstructive Surgery, São João University Hospital; the Department of Surgery and Physiology, Faculty of Medicine, Porto University; the Plastic Surgery Department, Portuguese Institute of Oncology of Porto; the Interdisciplinary Centre of Marine and Environmental Research; and the Department of Biology, Faculty of Sciences, University of Porto.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': ''}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Valença-Filipe', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': ''}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Peres', 'Affiliation': ''}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Costa-Ferreira', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007024']
1523,32741773,Ubiquinol supplementation in elderly patients undergoing aortic valve replacement: biochemical and clinical aspects.,"Epidemiological data show a rise in the mean age of patients affected by heart disease undergoing cardiac surgery. Senescent myocardium reduces the tolerance to ischemic stress and there are indications about age-associated deficit in post-operative cardiac performance. Coenzyme Q10 (CoQ10), and more specifically its reduced form ubiquinol (QH), improve several conditions related to bioenergetic deficit or increased exposure to oxidative stress. This trial (Eudra-CT 2009-015826-13) evaluated the clinical and biochemical effects of ubiquinol in 50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either placebo or 400 mg/day ubiquinol from 7 days before to 5 days after surgery. Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin I, CK-MB (primary endpoints), IL-6 and S100B were assessed. Moreover, main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints) were evaluated during a 6-month follow-up visit. Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin I (QH, 1.90 [1.47-2.48] ng/dL; placebo, 4.03 [2.45-6.63] ng/dL; p=0.007) related to cardiac surgery. Moreover, ubiquinol prevented the adverse outcomes that might have been associated with defective left ventricular ejection fraction recovery in elderly patients.",2020,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"['50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either', 'elderly patients undergoing aortic valve replacement', 'mean age of patients affected by heart disease undergoing cardiac surgery', 'elderly patients']","['Coenzyme Q10 (CoQ10', 'Ubiquinol supplementation', 'placebo or 400 mg/day ubiquinol', 'dL; placebo']","['Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin', 'troponin', 'main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints', 'post-operative plasma CoQ10 decline (p<0.0001) and oxidation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1272575', 'cui_str': 'Heart tissue'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3495916', 'cui_str': 'Myocardial hypertrophy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",50.0,0.241265,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Orlando', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Sabbatinelli', 'Affiliation': 'Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, Ancona 60100, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Silvestri', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Marcheggiani', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Cirilli', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Phiwayinkosi Vusi', 'Initials': 'PV', 'LastName': 'Dludla', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Molardi', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nicolini', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tiano', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}]",Aging,['10.18632/aging.103742']
1524,32738837,"Efficacy and Safety of a Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin Compared with Linezolid for Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Openlabel, Randomized Study.","Background


Levonadifloxacin is a novel broad-spectrum anti-MRSA agents belonging to the benzoquinolizine subclass of quinolone. It is developed for oral or intravenous administration for the treatment of infections caused by Gram-positive organisms including methicillin-resistant Staphylococcus aureus (MRSA).
Objectives


To establish the non-inferiority of levonadifloxacin compared with linezolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and to compare the safety of the two antimicrobials.
Subjects and methods


This was a Phase 3, multicentre, randomized, open-label, active- comparator study with 500 subjects. Oral levonadifloxacin 1000 mg was compared with oral linezolid 600 mg whereas IV levonadifloxacin 800mg was compared with IV linezolid 600 mg, each treatment was administered twice daily for 7-10 days. Non-inferiority was evaluated by comparing oral levonadifloxacin to oral linezolid and IV levonadifloxacin to IV linezolid for overall clinical response at TOC (Test of Cure) Visit.
Results


The clinical cure rates observed at the TOC in the mITT (modified Intent to treat) populations for levonadifloxacin was numerically higher compared to linezolid in the IV sub-group [(91.0% verses 87.8%); treatment difference of 3.2% (95%CI, -4.5 to 10.9)] and in the oral sub-group (95.2% versus 93.6%); treatment difference of 1.6 % [95%CI, -4.2 to 7.3]). As the lowerbound of the 95% CI around the treatment difference was greater than -15% for both subgroups, the primary objective of the study was met. Therefore, both IV levonadifloxacin and oral levonadifloxacin were non-inferior to IV linezolid and oral linezolid, respectively. The majority of subjects in the micro-ITT population had a baseline infection caused by S. aureus with approximately 30% of subjects having MRSA. Levonadifloxacin (IV and oral) had a higher clinical cure rate at TOC for MRSA patients compared with linezolid (IV and oral), (95.0% vs. 89.3% respectively). Levonadifloxacin showed evidence of favourable clinical and microbiological efficacy in subjects with concurrent bacteraemia as well as in subjects with diabetes including diabetic foot infections caused by Gram-positive pathogens including MRSA. Pharmacokinetic analysis showed that bioavailability of oral levonadifloxacin was 90% and similar pharmacokinetic profile of levonadifloxacin by both routes provide an option for IV to oral switch for the treatment of subjects. Incidences of treatment-emergent adverse events (TEAEs) were similar between treatment groups and between IV (20.8% vs. 22.4%, for levonadifloxacin and linezolid, respectively) and oral therapy (16.0% vs. 13.5%, respectively), There were no SAEs or deaths related to study drug and the majority of the AEs observed were mild in nature. Overall, the administration of both IV and oral levonadifloxacin was well-tolerated in subjects with ABSSSI.
Conclusions


The results demonstrate that IV and oral levonadifloxacin therapy has excellent clinical activity against MRSA and offers advantage compared to other quinolones which generally lack MRSA coverage. Levonadifloxacin is safe and well tolerated in the treatment of ABSSSI caused by Gram -positive pathogens including MRSA as well as non-inferior to IV and oral linezolid, respectively. Similar pharmacokinetic profile of IV and oral levonadifloxacin provides an option for IV to oral switch for the treatment of subjects. Both oral and IV levonadifloxacin have recently been granted approval in India for the treatment of ABSSSI including diabetic foot infections and concurrent bacteraemia in adults (18 years of age or older). ClinicalTrials.gov Registration: NCT03405064. CTRI No.: CTRI/2017/06/008843.",2020,"Levonadifloxacin (IV and oral) had a higher clinical cure rate at TOC for MRSA patients compared with linezolid (IV and oral), (95.0% vs. 89.3% respectively).","['subjects with ABSSSI', 'adults (18 years of age or older', '500 subjects', 'acute bacterial skin and skin structure infections (ABSSSI', 'subjects', 'Subjects and methods']","['linezolid and oral linezolid', 'oral linezolid 600 mg whereas IV levonadifloxacin', 'levonadifloxacin and oral levonadifloxacin', 'linezolid and IV levonadifloxacin to IV linezolid', 'Linezolid', 'levonadifloxacin', 'Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin', 'Levonadifloxacin', 'IV and oral levonadifloxacin', 'linezolid', 'Oral levonadifloxacin']","['Efficacy and Safety', 'favourable clinical and microbiological efficacy', 'Incidences of treatment-emergent adverse events (TEAEs', 'clinical cure rate', 'bioavailability of oral levonadifloxacin', 'clinical cure rates']","[{'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1127473', 'cui_str': 'linezolid 600 MG'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",,0.0470759,"Levonadifloxacin (IV and oral) had a higher clinical cure rate at TOC for MRSA patients compared with linezolid (IV and oral), (95.0% vs. 89.3% respectively).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mastim', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutte', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joshi', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kumbhar', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Periasamy', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Palwe', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chavan', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhagwat', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Llorens', 'Affiliation': ""Wockhardt's Morton Grove Pharmaceuticals Inc., Morton Grove, Illinois, USA.""}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Friedland', 'Affiliation': ""Wockhardt's Morton Grove Pharmaceuticals Inc., Morton Grove, Illinois, USA.""}]",The Journal of the Association of Physicians of India,[]
1525,32738955,"Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial.","BACKGROUND


Treatment of dysplastic Barrett's oesophagus prevents progression to adenocarcinoma; however, the optimal diagnostic strategy for Barrett's oesophagus is unclear. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus. The aim of this study was to investigate whether offering this test to patients on medication for gastro-oesophageal reflux would increase the detection of Barrett's oesophagus compared with standard management.
METHODS


This multicentre, pragmatic, randomised controlled trial was done in 109 socio-demographically diverse general practice clinics in England. Randomisation was done both at the general practice clinic level (cluster randomisation) and at the individual patient level, and the results for each type of randomisation were analysed separately before being combined. Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years. General practice clinics were selected by the local clinical research network and invited to participate in the trial. For cluster randomisation, clinics were randomly assigned (1:1) by the trial statistician using a computer-generated randomisation sequence; for individual patient-level randomisation, patients were randomly assigned (1:1) by the general practice clinics using a centrally prepared computer-generated randomisation sequence. After randomisation, participants received either standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group). The primary outcome was the diagnosis of Barrett's oesophagus at 12 months after enrolment, expressed as a rate per 1000 person-years, in all participants in the intervention group (regardless of whether they had accepted the offer of the Cytosponge-TFF3 procedure) compared with all participants in the usual care group. Analyses were intention-to-treat. The trial is registered with the ISRCTN registry, ISRCTN68382401, and is completed.
FINDINGS


Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation. Using an automated search of the electronic prescribing records of the remaining 109 clinics, we identified 13 657 eligible patients who were sent an introductory letter with 14 days to opt out. 13 514 of these patients were randomly assigned (per practice or at the individual patient level) to the usual care group (n=6531) or the intervention group (n=6983). Following randomisation, 149 (2%) of 6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study. Of the remaining 6834 participants in the intervention group, 2679 (39%) expressed an interest in undergoing the Cytosponge-TFF3 procedure. Of these, 1750 (65%) met all of the eligibility criteria on telephone screening and underwent the procedure. Most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample. 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy. Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner. During an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (<1%) of 6388 participants in the usual care group were diagnosed with Barrett's oesophagus (absolute difference 18·3 per 1000 person-years [95% CI 14·8-21·8]; rate ratio adjusted for cluster randomisation 10·6 [95% CI 6·0-18·8], p<0·0001). Nine (<1%) of 6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage I oesophago-gastric cancer (n=5) in the intervention group, whereas no participants were diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer in the usual care group. Among 1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer. One patient had a detachment of the Cytosponge from the thread requiring endoscopic removal, and the most common side-effect was a sore throat in 63 (4%) of 1654 participants.
INTERPRETATION


In patients with gastro-oesophageal reflux, the offer of Cytosponge-TFF3 testing results in improved detection of Barrett's oesophagus. Cytosponge-TFF3 testing could also lead to the diagnosis of treatable dysplasia and early cancer. This strategy will lead to additional endoscopies with some false positive results.
FUNDING


Cancer Research UK, National Institute for Health Research, the UK National Health Service, Medtronic, and the Medical Research Council.",2020,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"['Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years', 'Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner', 'remaining 109 clinics, we identified 13\u2008657 eligible patients who were sent an introductory letter with 14 days to opt out', '6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study', 'Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation', ""1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer"", ""6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage"", '231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy', '109 socio-demographically diverse general practice clinics in England', 'patients with gastro-oesophageal reflux']","[""Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus"", 'standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group']","[""diagnosis of Barrett's oesophagus"", ""diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer"", ""diagnosed with Barrett's oesophagus""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",6834.0,0.132661,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Fitzgerald', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK. Electronic address: rcf29@mrc-cu.cam.ac.uk.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'di Pietro', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""O'Donovan"", 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maroni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Muldrew', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Debiram-Beecham', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Gehrung', 'Affiliation': 'Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Offman', 'Affiliation': ""Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Samuel G', 'Initials': 'SG', 'LastName': 'Smith', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Aigret', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Walter', 'Affiliation': 'The Primary Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rubin', 'Affiliation': 'Institute of Population Health Sciences, Newcastle University, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)31099-0']
1526,32747329,Effect of an E-Learning Module on Personal Protective Equipment Proficiency Among Prehospital Personnel: Web-Based Randomized Controlled Trial.,"BACKGROUND


To avoid misuse of personal protective equipment (PPE), ensure health care workers' safety, and avoid shortages, effective communication of up-to-date infection control guidelines is essential. As prehospital teams are particularly at risk of contamination given their challenging work environment, a specific gamified electronic learning (e-learning) module targeting this audience might provide significant advantages as it requires neither the presence of learners nor the repetitive use of equipment for demonstration.
OBJECTIVE


The aim of this study was to evaluate whether a gamified e-learning module could improve the rate of adequate PPE choice by prehospital personnel in the context of the coronavirus disease (COVID-19) pandemic.
METHODS


This was an individual-level randomized, controlled, quadruple-blind (investigators, participants, outcome assessors, and data analysts) closed web-based trial. All emergency prehospital personnel working in Geneva, Switzerland, were eligible for inclusion, and were invited to participate by email in April 2020. Participants were informed that the study aim was to assess their knowledge regarding PPE, and that they would be presented with both the guidelines and the e-learning module, though they were unaware that there were two different study paths. All participants first answered a preintervention quiz designed to establish their profile and baseline knowledge. The control group then accessed the guidelines before answering a second set of questions, and were then granted access to the e-learning module. The e-learning group was shown the e-learning module right after the guidelines and before answering the second set of questions.
RESULTS


Of the 291 randomized participants, 176 (60.5%) completed the trial. There was no significant difference in baseline knowledge between groups. Though the baseline proportion of adequate PPE choice was high (75%, IQR 50%-75%), participants' description of the donning sequence was in most cases incorrect. After either intervention, adequate choice of PPE increased significantly in both groups (P<.001). Though the median of the difference in the proportion of correct answers was slightly higher in the e-learning group (17%, IQR 8%-33% versus 8%, IQR 8%-33%), the difference was not statistically significant (P=.27). Confidence in the ability to use PPE was maintained in the e-learning group (P=.27) but significantly decreased in the control group (P=.04).
CONCLUSIONS


Among prehospital personnel with an already relatively high knowledge of and experience with PPE use, both web-based study paths increased the rate of adequate choice of PPE. There was no major added value of the gamified e-learning module apart from preserving participants' confidence in their ability to correctly use PPE.",2020,"There was no major added value of the gamified e-learning module apart from preserving participants' confidence in their ability of correctly using PPE.
","['Out of the 291 randomized participants, 176 (60.5%) completed the trial', 'Personal Protective Equipment Proficiency by Prehospital Personnel', 'All emergency prehospital personnel working in Geneva, Switzerland, were eligible for inclusion, and were invited to participate by e-mail, in April 2020']","['gamified e-learning module', 'E-Learning Module', 'personal protective equipment (PPE']","['baseline knowledge', 'adequate PPE choice', 'proportion of correct answers', 'adequate choice of PPE']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",291.0,0.0691654,"There was no major added value of the gamified e-learning module apart from preserving participants' confidence in their ability of correctly using PPE.
","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abbas', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Geneva, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottet', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larribau', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Golay', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Iten', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Gartner', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Suppan', 'Affiliation': 'Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",Journal of medical Internet research,['10.2196/21265']
1527,32745732,Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization.,"BACKGROUND


Secondary preventive therapies play a key role in the prevention of adverse events after coronary artery bypass grafting (CABG). However, adherence to secondary preventive drugs after CABG is often poor. With the increasing penetration of smartphones, health-related smartphone applications might provide an opportunity to improve medication adherence. We aimed to evaluate the effectiveness and feasibility of using a smartphone-based application to improve medication adherence in patients after CABG.
METHODS


The Measurement and Improvement Studies of Surgical coronary revascularizatION: medication adherence (MISSION-2) study is a multicenter randomized controlled trial that planned to enroll over 1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications. The investigators randomly assigned the participants to one of two groups: (1) the intervention group with an advanced smartphone application for 6 months which was designed specifically for this trial and did not exist before. Participants could receive medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care. The primary outcome was CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 6 months after randomization. The secondary outcomes were mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status. All analyses were conducted using the intention-to-treat principle.
RESULTS


A total of 1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016 and were randomly assigned to the intervention (n = 501) or control group (n = 499). At 6 months, the proportion of low-adherence participants, categorized by MMAS-8 scores, was 11.8% in the intervention group and 11.7% in the control group (RR = 1.005, 95% CI 0.682 to 1.480, P = 1.000). Similar results were found in sensitivity analyses that considered participants who withdrew from the study, or were lost to follow-up as nonadherent. There were no significant differences in the secondary clinical outcome measures, and there were no significant differences in the primary outcome across the subgroups tested. In the intervention group, the proportion of participants who used and operated the application during the first month after CABG was 88.1%; however, the use rate decreased sharply from 42.5% in the second month to 9.2% by the end of the study (6 months).
CONCLUSIONS


A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications. The limited room for improvement in medication adherence and the low participants' engagement with the smartphone applications might account for these non-significant outcomes.",2020,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"['patients after CABG', 'coronary artery bypass grafting (CABG', 'patients after surgical coronary revascularization', '1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications', '1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016']","['Surgical coronary revascularizatION', 'smartphone-based application', 'Smartphone-based application', 'medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care', 'intervention group with an advanced smartphone application']","['proportion of low-adherence participants, categorized by MMAS-8 scores', 'mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status', 'CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1000.0,0.0677726,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"[{'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chongyang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junzhe', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanning', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Tianjin, China.'}, {'ForeName': 'Chenfei', 'Initials': 'C', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: raochenfeifuwai@126.com.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: zhengzhe@fuwai.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.019']
1528,32745733,"Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial).","BACKGROUND


Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk.
METHODS/DESIGN


The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life.
DISCUSSION


The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis.
TRIAL REGISTRATION


clinicaltrials.gov: NCT04160130.",2020,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","['440 patients across 35 sites in Europe', 'female than male patients', 'Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status', 'female patients with severe symptomatic aortic stenosis', 'women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk', 'female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA', 'women with severe symptomatic aortic stenosis']","['surgical aortic valve replacement (SAVR', 'transcatheter (TAVR', 'transcatheter heart valve replacement', 'TAVR with SAVR', 'TAVR']","['composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure', 'safety and efficacy', 'cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0182431', 'cui_str': 'Aortic valve prosthesis'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.159675,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Eltchaninoff', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, Rouen, France. Electronic address: helene.eltchaninoff@chu-rouen.fr.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Bonaros', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@tirol-kliniken.at.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prendergast', 'Affiliation': ""St. Thomas' Hospital, London, United Kingdom. Electronic address: bernard.prendergast@gstt.nhs.uk.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Nietlispach', 'Affiliation': 'CardioVascularCenter, Hirslanden Klinik Im Park, Zurich, Switzerland. Electronic address: fabian.nietlispach@hirslanden.ch.'}, {'ForeName': 'Mariuca', 'Initials': 'M', 'LastName': 'Vasa-Nicotera', 'Affiliation': 'University Heart Center Frankfurt, Frankfurt, Germany. Electronic address: mariuca.vasa-nicotera@kgu.de.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada. Electronic address: philippe.pibarot@med.ulaval.ca.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: peter.bramlage@ippmed.de.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Sykorova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: lenka_sykorova@edwards.com.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kurucova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: jana_kurucova@edwards.com.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.j.bax@lumc.nl.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: Stephan.Windecker@insel.ch.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: ndumonteil@clinique-pasteur.com.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: dtchetche@clinique-pasteur.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.016']
1529,32745734,Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial.,"BACKGROUND


Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system.
TRIAL DESIGN


OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
CONCLUSIONS


OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.",2020,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","['480 event-free patients will undergo repeat AMCE', 'patients receiving different antiplatelet therapy regimens after stent implantation', 'patients treated with antiplatelet agents after percutaneous coronary intervention (PCI']","['aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo', 'open-label aspirin', 'clopidogrel', 'placebo']","['incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding', 'gastrointestinal erosions, ulceration or bleeding']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1261962', 'cui_str': 'Gastrointestinal erosion'}]",,0.524049,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Endoscopy, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Heyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.06.004']
1530,32745830,A randomised trial comparing a brief online delivery of mindfulness-plus-values versus values only for symptoms of depression: Does baseline severity matter?,"BACKGROUND


Acceptance/mindfulness-based interventions often focus on (a) developing dispositional mindfulness and (b) pursuing personally meaningful and valued activities. Acceptance/mindfulness-based interventions can reduce depression, but little is known about the combined effects of components or the influence of baseline variables on outcomes. This study tested whether practicing a brief (10-min) mindfulness meditation over a 2-week period followed by a single values session (mindfulness+values) was more effective than values alone (values only) in reducing symptoms of depression. The study was delivered online and modules were fully self-help (i.e., no therapist contact).
METHODS


206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10) were randomised to: mindfulness+values condition or a 2-week wait period followed by the values session (i.e., values only condition). Symptoms of depression were assessed at baseline, after the 2-week mindfulness practice/wait period, and 1-week following the values session.
RESULTS


Reductions in depression and recovery rates were significantly greater following mindfulness+values than values only. Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression. Outcomes did not differ for those with low levels of depression. Rates of deterioration were higher than expected for values only participants.
LIMITATIONS


Conclusions are preliminary and tentative due to no follow-up period and a small sample. Drop-out was high (50%) and findings cannot be assumed to generalise to treatment seeking or more diverse samples.
CONCLUSIONS


Tentatively, results suggest mindfulness+values can significantly reduce depression, especially for individuals with higher baseline depression.",2020,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"['206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10']","['mindfulness-plus-values', 'practicing a brief (10-min) mindfulness meditation']","['Symptoms of depression', 'Rates of deterioration', 'depression and recovery rates']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",206.0,0.0678318,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kingston', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom. Electronic address: Jessica.kingston@rhul.ac.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Becker', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Woeginger', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.087']
1531,32745945,"Chasing the desire: An investigation on the role of craving, time perspective, and alcohol use in adolescent gambling.","Chasing, or continuing to gamble to recoup losses, is a behavioral marker and a diagnostic criterion for gambling disorder. Research on chasing has focused mainly on adults, whereas the analysis of chasing behavior among adolescents has not received empirical attention in the gambling literature. The aim of the present study was to first investigate the interplay between chasing behavior, craving, temporal perspective, alcohol use, and gambling severity among Italian adolescents. Three hundred and sixty-four adolescents took part in the study. Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior. Participants were randomly assigned to the control and the loss condition of the computerized task. Results indicated that the choice to continue playing, as well as chasing frequency did not vary as a function of experimental condition. Hierarchical logistic and linear regression analyses revealed that the decision to chase depended mostly on craving, whereas chasing propensity was affected by craving and alcohol misuse. Notably, gambling severity did not predict either the decision to chase, or the chasing persistence. The present study contributes important findings to the gambling literature, highlighting the role of craving alcohol use in facilitating the inability to stop within-sessions gambling among adolescents. These findings may provide evidence that nonchasers and chasers represent two different types of gamblers, and that the difference may be useful for targeting more effective therapies.",2020,"Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior.","['Chasing the desire', 'Three hundred and sixty-four adolescents took part in the study', 'Italian adolescents', 'adolescent gambling']",[],"['South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]",[],"[{'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",364.0,0.0202985,"Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cosenza', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: marina.cosenza@unicampania.it.'}, {'ForeName': 'Olimpia', 'Initials': 'O', 'LastName': 'Matarazzo', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: olimpia.matarazzo@unicampania.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ciccarelli', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: maria.ciccarelli@unicampania.it.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Nigro', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: giovanna.nigro@unicampania.it.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106566']
1532,32745964,"Impact of sex and age on chemotherapy efficacy, toxicity and survival in localised oesophagogastric cancer: A pooled analysis of 3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03).","BACKGROUND


There is a lack of large-scale randomised data evaluating the impact of sex and age in patients undergoing chemotherapy followed by potentially curative surgery for oesophagogastric cancer.
PATIENTS AND METHODS


Individual patient data from four prospective randomised controlled trials were pooled using a two-stage meta-analysis. For survival analysis, hazard ratios (HRs) were calculated for patients aged <70 and ≥ 70 years, as well as between males and females. Mandard tumour regression grade (TRG) and, ≥grade III toxicities were compared using logistic regression models to calculate odds ratios. All analyses were adjusted for the type of chemotherapy received.
RESULTS


3265 patients were included for survival analysis (2668 [82%] male, 597 [18%] female; 2627 (80%) <70 years, 638 (20%) ≥70 years). A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males. No significant differences in OS (HR: 1.11; p = 0.045) or DSS (HR: 1.01; p = 0.821) were observed in older patients compared with younger patients. For patients who underwent resection, older patients (15% vs 10%; p = 0.03) and female patients (14% vs 10%, p = 0.10) were more likely to achieve favourable Mandard TRG scores. Females experienced significantly more ≥grade III nausea (10% vs 5%; p≤0.001), vomiting (10% vs 4%; p≤0.001) and diarrhoea (9% vs 4%; p≤0.001) than males.
CONCLUSIONS


In this large pooled analysis using prospective randomised trial data, females had significantly improved survival while experiencing more gastrointestinal toxicities. Older patients achieved comparable survival to younger patients and thus, dependent on fitness, should be offered the same treatment paradigm.",2020,A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males.,"['Older patients', '3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03', 'localised oesophagogastric cancer', 'patients undergoing chemotherapy followed by potentially curative surgery for oesophagogastric cancer', '3265 patients were included for survival analysis (2668 [82%] male, 597 [18%] female; 2627 (80%) <70 years, 638 (20%) ≥70 years']",[],"['chemotherapy efficacy, toxicity and survival', '≥grade III nausea', 'Mandard tumour regression grade (TRG) and, ≥grade III toxicities', 'favourable Mandard TRG scores', 'diarrhoea', 'survival', 'gastrointestinal toxicities', 'vomiting', 'disease-specific survival (DSS', 'overall survival (OS', 'For survival analysis, hazard ratios (HRs']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024460', 'cui_str': 'Magic'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",3265.0,0.254262,A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males.,"[{'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Athauda', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nankivell', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, Second Floor, London, WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, Second Floor, London, WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Alderson', 'Affiliation': 'Department of Surgery, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Allum', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands; Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, LS9 7TF, United Kingdom.""}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom. Electronic address: david.cunningham@rmh.nhs.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.005']
1533,32746598,[Effects of desflurane and sevoflurane anesthesia on postoperative recovery after long-term tumor surgery].,"Objective:  To analyze the effects of desflurane and sevoflurane anesthesia on postoperative recovery after long lasting tumor surgery.  Methods:  One hundred and sixty patients undergoing endoscopic radical esophagectomy and gastrectomy (80 cases of each surgical type) from November 2019 to March 2020 at Henan Cancer Hospital, were randomized into 4 groups( n= 40): group CS (esophageal cancer+sevoflurane anesthesia), group DS (esophageal cancer+desflurane anesthesia),group CW (stomach cancer+sevoflurane anesthesia) and group DW (gastric cancer+desflurane anesthesia). General anesthesia was induced by intravenous agents in all four groups, which were maintained by inhaled anesthetic during the operation. The mean arterial pressure (MAP), heart rate (HR), and surplus pulse O(2) (SpO(2)) immediately before induction (T(1)), the moment of operation begin (T(2)), operation end (T(3)) and extubation (T(4)) were recorded. Also, the duration required for inhalation anesthetic alveolar concentration reaching 0.5 minimum alveolar concentration (MAC) during induction, the alveolar anesthetic concentration at the beginning of the operation, the duration required for XMAC (patients specific alveolar concentration) declining to 0.5 MAC on recovery period, and the duration of alveolar concentration of 0.5 MAC declining to 0.2 MAC were determined. Additionally, the durations of spontaneous breathing recovery, eyes opening, extubation and recovery of consciousness were recorded. Finally, restlessness score (RS) during recovery period was used to evaluate postoperative agitation.  Results:  Compared with group CS and group CW, no significant differences in MAP, HR, SpO(2) in group DS and group DW at T(1) to T(4) were found (all  P> 0.05). The durations required for inhalation anesthetic alveolar concentration reaching 0.5 MAC were (5.6±1.3), (5.8±2.1), (3.5±1.5) and (3.8±1.0) min in group CS, group CW, group DS and group DW, where the durations in group DS and group DW were significantly shorter than those in group CS and group CW ( F= 32.538,  P< 0.05). The durations of alveolar concentration of 0.5 MAC declining to 0.2 MAC were (6.4±2.2), (7.0±1.5), (4.2±2.2) and (4.1±1.5) min in group CS, group CW, group DS and group DW, and the durations in group DS and group DW were significantly shortened as compared with group CS and group CW ( F= 42.113,  P< 0.05). Compared with group CS and group CW, group DS and group DW required significantly shorter time for spontaneous breathing recovery, eye opening,extubation, and directional force recovery after operation (all  P< 0.05).  Conclusions:  Both desflurane and sevoflurane anesthesia can achieve satisfactory anesthesia depth during long lasting tumor surgery. Desflurane can shorten the recovery time and early extubation, and improve the quality of recovery.",2020,"Compared with group CS and group CW, no significant differences in MAP, HR, SpO(2) in group DS and group DW at T(1) to T(4) were found (all  P> 0.05).","['80 cases of each surgical type) from November 2019 to March 2020 at Henan Cancer Hospital', 'after long-term tumor surgery', 'One hundred and sixty patients undergoing']","['CS (esophageal cancer+sevoflurane anesthesia), group DS (esophageal cancer+desflurane anesthesia),group CW (stomach cancer+sevoflurane anesthesia) and group DW (gastric cancer+desflurane anesthesia', 'desflurane and sevoflurane anesthesia', 'endoscopic radical esophagectomy and gastrectomy', 'Desflurane']","['duration of alveolar concentration', 'durations required for inhalation anesthetic alveolar concentration reaching 0.5 MAC', 'restlessness score (RS', 'postoperative recovery', 'duration required for inhalation anesthetic alveolar concentration reaching 0.5 minimum alveolar concentration (MAC) during induction, the alveolar anesthetic concentration', 'MAP, HR, SpO(2', 'shorter time for spontaneous breathing recovery, eye opening,extubation, and directional force recovery', 'recovery time and early extubation', 'durations of alveolar concentration of 0.5 MAC declining to 0.2 MAC', 'satisfactory anesthesia depth', 'mean arterial pressure (MAP), heart rate (HR), and surplus pulse O(2) (SpO(2)) immediately before induction (T(1)), the moment of operation begin (T(2)), operation end (T(3)) and extubation (T(4', 'quality of recovery', 'durations of spontaneous breathing recovery, eyes opening, extubation and recovery of consciousness']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}]",160.0,0.01659,"Compared with group CS and group CW, no significant differences in MAP, HR, SpO(2) in group DS and group DW at T(1) to T(4) were found (all  P> 0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Cancer Hospital, Fudan University, Shanghai 200032, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200422-01273']
1534,32746602,[Efficacy of thymectomy in patients with non-thymoma myasthenia gravis].,"Objective:  To compare the efficacy between thymectomy plus prednisone and prednisone alone in patients with non-thymoma myasthenia gravis (MG).  Methods:  Thirty generalized MG patients without thymoma who underwent thymectomy were collected as the operation group, and thirty-nine patients without thymectomy who were treated with prednisone alone were matched as the control group. The start point was the enrollment time and the endpoint event was the ""clinical remission"" (including complete stabilization remission, drug remission, and poor performance). The survival curve was used to analyze the difference of endpoint event time between the two groups. Besides, a 12-month follow-up study was conducted to compare relevant clinical indicators between the two groups.  Results:  There was no significant difference in the occurrence time of endpoint events between the two groups ( P= 0.614). After 6-month follow-up, no significant differences were found in clinical remission rate, the dosage of pyridostigmine bromide and prednisone, the peak dosage of prednisone, the use of other immunosuppressive medications and the rate of hospitalization for exacerbation of disease between the two groups (all  P> 0.05). After 12-month follow-up, the dosage of prednisone and pyridostigmine in the operation group was significantly lower than that in the control group (5(0,10)mg/d vs 7.5(5,10)mg/d and 30(0,105)mg/d vs 90(15,180)mg/d;  P= 0.038, 0.032).  Conclusion:  In patients with mild to moderate non-thymoma generalized MG, thymectomy does not achieve faster remission, but it does reduce the long-term dosage of prednisone and bromopyrazine.",2020,There was no significant difference in the occurrence time of endpoint events between the two groups ( P= 0.614).,"['Thirty generalized MG patients without thymoma who underwent thymectomy were collected as the operation group, and thirty-nine patients without thymectomy who were treated with', 'patients with non-thymoma myasthenia gravis', 'patients with non-thymoma myasthenia gravis (MG']","['prednisone', 'thymectomy', 'prednisone and pyridostigmine', 'thymectomy plus prednisone and prednisone alone', 'pyridostigmine bromide and prednisone']","['clinical remission"" (including complete stabilization remission, drug remission, and poor performance', 'survival curve', 'rate of hospitalization for exacerbation of disease', 'occurrence time of endpoint events', 'clinical remission rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040100', 'cui_str': 'Thymoma'}, {'cui': 'C0040071', 'cui_str': 'Excision of thymus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040071', 'cui_str': 'Excision of thymus'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034262', 'cui_str': 'Pyridostigmine bromide'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0235874', 'cui_str': 'Condition aggravated'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",39.0,0.0160311,There was no significant difference in the occurrence time of endpoint events between the two groups ( P= 0.614).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, China [Yang Song is now working at the Department of Neurology, the Third Affiliated Hospital of Soochow University (Changzhou First People's Hospital), Changzhou 213003, China].""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Huan', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191206-02664']
1535,32749938,Bevacizumab Plus mFOLFOX6 Versus mFOLFOX6 Alone as First-Line Treatment for  RAS  Mutant Unresectable Colorectal Liver-Limited Metastases: The BECOME Randomized Controlled Trial.,"PURPOSE


To assess the effects of bevacizumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) as first-line treatment of  RAS  mutant unresectable colorectal liver metastases.
METHODS


From October 2013 to December 2017, patients with  RAS  mutant unresectable liver-limited metastases from colorectal cancer were randomly assigned to receive mFOLFOX6 plus bevacizumab (arm A) or mFOLFOX6 alone (arm B). The resectability of liver metastases was determined by a local multidisciplinary team. The primary end point was the actual rate of patients converted to R0 resection for liver metastases. Secondary end points included tumor response, survival, and toxicity. The block randomization method was used.
RESULTS


The intention-to-treat population comprised 241 patients. A total of 121 patients were randomly assigned to arm A and 120 to arm B. The median follow-up time was 37.0 months for all patients. The R0 resection rates for liver metastases were 22.3% (27 of 121 patients) in arm A and 5.8% (7 of 120 patients) in arm B, with a significant difference ( P  < .01). Patients in arm A had significantly better objective response rates (54.5%  v  36.7%;  P  < .01), median progression-free survival (9.5  v  5.6 months;  P  < .01) and median overall survival (25.7  v  20.5 months;  P  = .03) compared with those in arm B. The addition of bevacizumab was associated with more frequent proteinuria (9.9%  v  3.3%;  P  = .04) and hypertension (8.3%  v  2.5%;  P  < .05).
CONCLUSION


For patients with initially unresectable  RAS  mutant colorectal liver metastases, bevacizumab combined with mFOLFOX6 increased the resectability of liver metastases and improved response rates and survival compared with mFOLFOX6 alone.",2020,"The R0 resection rates for liver metastases were 22.3% (27 of 121 patients) in arm A and 5.8% (7 of 120 patients) in arm B, with a significant difference ( P  < .01).","['From October 2013 to December 2017', 'RAS  Mutant Unresectable Colorectal Liver-Limited Metastases', 'patients with  RAS  mutant unresectable liver-limited metastases from colorectal cancer', 'RAS  mutant unresectable colorectal liver metastases', 'A total of 121 patients were randomly assigned to arm A and 120 to arm B']","['mFOLFOX6 plus bevacizumab (arm A) or mFOLFOX6 alone', 'bevacizumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6', 'Bevacizumab Plus mFOLFOX6 Versus mFOLFOX6 Alone', 'bevacizumab']","['frequent proteinuria', 'median progression-free survival', 'resectability of liver metastases', 'R0 resection rates for liver metastases', 'objective response rates', 'median overall survival', 'actual rate of patients converted to R0 resection for liver metastases', 'response rates and survival', 'hypertension', 'tumor response, survival, and toxicity']","[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",121.0,0.164236,"The R0 resection rates for liver metastases were 22.3% (27 of 121 patients) in arm A and 5.8% (7 of 120 patients) in arm B, with a significant difference ( P  < .01).","[{'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': ""Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'He', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': ""Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ""Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00174']
1536,32750332,The effect of oxytocin on pupil response to naturalistic dynamic facial expressions.,"The neuropeptide oxytocin (OT) has been found to play an important role in a variety of social behaviours and social cognition in particular. The social salience hypothesis of OT suggests that OT shifts attention towards socially relevant stimuli, which offers an explanation for improvements on social cognition measures following OT administration. Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention. The current study aimed to investigate the effects of OT on pupillary responses to more naturalistic social stimuli in a larger sample. Ninety-four male participants took part in the double-blind, placebo controlled, mixed-design study, in which they self-administered either an OT or PL nasal spray before viewing naturalistic dynamic facial expressions of emotion (happy, sad, fear and anger). Contrary to prediction, there was no effect of OT administration on pupil diameter. The results are discussed in light of the social salience hypothesis and with reference to the methodological differences between studies.",2020,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.",['Ninety-four male participants took part in the double-blind'],"['OT', 'oxytocin', 'OT or PL nasal spray', 'neuropeptide oxytocin (OT', 'placebo']","['social cognition measures', 'pupil response to naturalistic dynamic facial expressions', 'emotion (happy, sad, fear and anger']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",94.0,0.0408089,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.","[{'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Burley', 'Affiliation': 'Cardiff University Centre for Human Developmental Science, School of Psychology, Cardiff University, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Daughters', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University, United Kingdom of Great Britain and Northern Ireland. Electronic address: k.daughters@essex.ac.uk.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104837']
1537,32750393,Efficacy and safety of one-month DAPT followed by 23-month ticagrelor monotherapy in patients undergoing proximal LAD stenting: Insights from the GLOBAL LEADERS trial.,"BACKGROUNDS


Data on optimal antiplatelet therapy in patients undergoing stenting of the proximal left anterior descending artery (LAD) are limited.
METHODS


This is a post-hoc analysis of the GLOBAL LEADERS trial, a prospective, multi-center, randomized controlled trial, comparing the experimental strategy (1-month dual anti-platelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) with the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in relation to stenting of the proximal LAD. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years.
RESULTS


Among 15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not. In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P interaction  = 0.951). However, the risk of any MI (2.63% vs. 3.88%; HR:0.68; 95% CI:0.47-0.97; P interaction  = 0.015) and any revascularization (7.84% vs. 9.94%; HR:0.78; 95% CI:0.63-0.97; P interaction  = 0.058) was significantly lower in the experimental strategy group, while demonstrating a similar risk of BARC type 3 or 5 bleeding between the two antiplatelet strategies (1.93% vs. 1.99%; HR:0.98; 95% CI:0.62-1.54; P interaction  = 0.981).
CONCLUSIONS


The present study showed patients having stenting to the proximal LAD could potentially benefit from the experimental strategy with lower ischaemic events without a trade-off in major bleeding at two years.",2020,"In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P interaction  = 0.951).","['patients having stenting to the proximal LAD', 'patients undergoing proximal LAD stenting', 'patients undergoing stenting of the proximal left anterior descending artery (LAD', '15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not']","['dual anti-platelet therapy [DAPT', 'aspirin monotherapy', 'ticagrelor monotherapy']","['risk of any MI', 'Efficacy and safety', 'composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C5197905', 'cui_str': 'Dual Anti-Platelet Therapy'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0439234', 'cui_str': 'year'}]",15845.0,0.0682053,"In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P interaction  = 0.951).","[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Depatment of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Depatment of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Werner', 'Affiliation': 'Department of Medicine II, Heart Center, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Teiger', 'Affiliation': 'University Hospital Henri Mondor, Créteil, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Almeida', 'Affiliation': 'Hospital de Santa Cruz, Lisbon, Portugal.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Barraud', 'Affiliation': 'Clinique des Dômes, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lantelme', 'Affiliation': 'Hôpital de la Croix-Rousse, Lyon, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barlis', 'Affiliation': ""Northern Hospital, Epping, Australia; St. Vincent's Heart Centre, Fitzroy, Australia.""}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Kerckhoff Heartand Thorax Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa, Ziekenhuis, Hasselt, Belgium, Faculty of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.07.042']
1538,32750431,Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.,"BACKGROUND


Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss.
METHODS


Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support.
DISCUSSION


This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.",2020,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.",['Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity'],"['training in principles of cognitive behavioral therapy', 'standard weight management program alone or with their partner']","['Partner weight and caloric intake', 'participant weight loss at 24\u202fmonths, with caloric intake and moderate-intensity physical activity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0164121,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.","[{'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA; William S Middleton Memorial Veterans Hospital, 2500 Overlook Terrace (151), Madison, WI 53705, USA. Electronic address: voils@surgery.wisc.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shaw', 'Affiliation': 'Duke University School of Nursing, 307 Trent Dr., 1055 Clipp, Durham, NC 27710, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Adler', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, One Brigham Circle, 1620 Tremont Street Suite 2-016, Boston, MA 02120, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jeanes', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, 119 S. Main St., Union Trust Bldg., Suite 220, Seattle, WA 98104, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Sharp', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Cronin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Johnson', 'Affiliation': ""Boca Raton Regional Hospital, Christine E. Lynn Women's Health & Wellness Institute, 690 Meadows Road, Boca Raton, FL 33486, USA.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Elwert', 'Affiliation': 'University of Wisconsin-Madison Department of Sociology, 11800 Observatory Dr, Madison, WI 53706, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Pabich', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Medicine, 1685 Highland Ave Madison, WI 53705-2281, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Gavin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University School of Medicine, Department of Medicine, 501 Douglas St., Durham, NC 27705, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Box 90399, Durham, NC 27708, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106092']
1539,32750502,"Impact of age on efficacy and early mortality of initial sequential treatment versus upfront combination chemotherapy in patients with metastatic colorectal cancer: a subgroup analysis of a phase III trial (AIO KRK0110, XELAVIRI study).","INTRODUCTION


The XELAVIRI study compared application of fluoropyrimidine (FP) and bevacizumab (Bev) followed by sequential escalation to irinotecan (Iri), FP and Bev (arm A) to upfront combination therapy with FP, Iri and Bev (arm B) in patients with metastatic colorectal cancer (mCRC). To elucidate the impact of age on survival, we evaluated efficacy and early mortality in the underlying trial.
METHODS


Patients were stratified for age in three cohorts (<65 years, 65-74 years and ≥75 years). Survival end-points were expressed by the Kaplan-Meier method and compared by log-rank testing and Cox regression. Objective response and 60-day mortality were evaluated by chi-square testing.
RESULTS


The efficacy analyses suggest more substantial benefit from upfront combination chemotherapy in younger patients with mCRC. Elderly patients (≥75 years) derived limited benefit from upfront combination chemotherapy, particularly in terms of overall survival. Of 421 randomised patients, 13 patients (3.1%) died within 60 days after treatment initiation with the highest prevalence in elderly patients (1.6% < 65 years, 2.8% 65-74 years and 5.2% ≥ 75 years, p = 0.26). The frequency of 60-day mortality was significantly associated with age (with a maximum of 8.7% in patients aged ≥75 years) in patients undergoing upfront combination therapy (p = 0.027) but not in patients receiving sequential treatment (p = 0.63).
CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm. These patients appear to be at a relevant risk for 60-day mortality under Iri-based combination chemotherapy plus Bev.",2020,"CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm.","['patients with metastatic colorectal cancer', 'Elderly patients (≥75 years', 'younger patients with mCRC', 'patients aged ≥75 years', 'Patients were stratified for age in three cohorts (<65 years, 65-74 years and ≥75 years', 'patients with metastatic colorectal cancer (mCRC']","['upfront combination chemotherapy', 'fluoropyrimidine (FP) and bevacizumab (Bev) followed by sequential escalation to irinotecan (Iri), FP and Bev (arm A) to upfront combination therapy with FP, Iri and Bev (arm B']","['Objective response and 60-day mortality', 'frequency of 60-day mortality', 'efficacy and early mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",421.0,0.107606,"CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm.","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kurreck', 'Affiliation': 'Charité University Medicine, Department of Hematology, Oncology, and Tumor Immunology (CVK), Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany; German Cancer Consortium (DKTK), DKFZ, Heidelberg, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Gesundheitszentrum St. Marien, Amberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Oncological Practice, Ravensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Oncological Practice, Landshut, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Uhlig', 'Affiliation': 'Oncological Practice, Naunhof, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenk', 'Affiliation': ""Clinic 'Barmherzige Brüder Regensburg', Regensburg, Germany.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Freiberg-Richter', 'Affiliation': 'Oncological Practice, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Peuser', 'Affiliation': 'Oncological Practice am Diakonissenhaus, Leipzig, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': 'Marienhospital, Stuttgart, Germany.'}, {'ForeName': 'Ullrich', 'Initials': 'U', 'LastName': 'Graeven', 'Affiliation': 'Kliniken Maria Hilf GmbH, Mönchengladbach, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schwaner', 'Affiliation': 'Oncological Practice Kurfürstendamm, Berlin, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Stahler', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'German Cancer Consortium (DKTK), DKFZ, Heidelberg, Germany; Ludwig Maximilians-University, Department of Pathology, Munich, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'Jobst C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Charité University Medicine Berlin, Department of Hematology, Oncology, and Tumor Immunology (CCM), Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Charité University Medicine Berlin, Department of Hematology, Oncology, and Tumor Immunology (CCM), Berlin, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Giessen-Jung', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Charité University Medicine, Department of Hematology, Oncology, and Tumor Immunology (CVK), Berlin, Germany. Electronic address: dominik.modest@charite.de.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.010']
1540,32750571,Recurrent venous thromboembolism during anticoagulation with edoxaban or warfarin: A post hoc analysis of the Hokusai-VTE trial.,"INTRODUCTION


Venous thromboembolism (VTE) may recur during anticoagulation, but the actual rate is not well established. In a post hoc analysis of the Hokusai-VTE trial we evaluated the risk and determinants of recurrent VTE of patients during anticoagulation with heparin, edoxaban or warfarin.
MATERIALS AND METHODS


The Hokusai-VTE study showed that in VTE patients edoxaban was non-inferior to warfarin with significantly less bleeding. Treatment duration ranged from 3 to 12 months. The recurrent VTE during anticoagulation period was defined as the VTE which occurred from the date of the first to the last dose (+3 days) of study drug.
RESULTS


147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment. Median duration of anticoagulation was 267 days. 80 (54%) patients recurred within the first 30 days, 39 of those during heparin lead-in. 23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%). 13 of those fatalities (57%) occurred during the first 30 days; 4 of those during heparin lead-in. The recurrence risk was numerically lower in patients assigned to edoxaban compared to those assigned to warfarin, particularly beyond 30 days. We observed a trend towards a higher proportion of men, high NT-proBNP levels and obesity at the time of diagnosis among patients with early recurrence and mortality in particular.
CONCLUSION


The risk of recurrent VTE and PE-related mortality during the time of anticoagulation is low but noteworthy. Further studies are warranted to sharpen the risk profile of VTE patients in order to improve treatment and reduce mortality.",2020,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"['23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6', '147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment']","['edoxaban', 'warfarin', 'heparin, edoxaban or warfarin', 'VTE patients edoxaban', 'edoxaban or warfarin']","['Median duration of anticoagulation', 'recurrence risk', 'Recurrent venous thromboembolism', 'bleeding']","[{'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",8240.0,0.0356656,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Eichinger', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria. Electronic address: sabine.eichinger@meduniwien.ac.at.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kyrle', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.028']
1541,32750626,Association of patient preferences on medication discussion in hypertension: Results from a randomized clinical trial.,"Patient-centered care has received significant attention and is an integral component of high-quality healthcare. While it is often assumed that most prefer a patient-centered role orientation, such preferences exist along a continuum with some patients preferring a more provider-centered role. The present study examines patient preference data from a randomized clinical trial designed to test the efficacy of a patient activation intervention to promote thiazide prescribing for veteran patients with uncontrolled hypertension. Patient preferences for involvement in healthcare were assessed using the 9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS). The primary aim was to examine differences in discussion of thiazide use in the clinical encounter by those scoring high versus low on the PPOS. Five hundred ninety-five veteran patients were randomized to either one of three intervention groups or a usual care control group. The adjusted odds ratios (OR) for the three intervention groups relative to the control group indicated that thiazide discussion increased as a function of intervention intensity across both high and low PPOS groups. ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients. Results suggest that this patient activation intervention is effective for veteran patients representing a range of preferred involvement. Consideration of such preferences may be useful in tailoring future interventions in the healthcare context.",2020,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","['Five hundred ninety-five veteran patients', 'veteran patients with uncontrolled hypertension', 'hypertension']","['patient activation intervention', 'thiazide prescribing', 'thiazide', 'activation intervention', 'usual care control group']","['9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS', 'adjusted odds ratios (OR', 'function of intervention intensity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",595.0,0.0335965,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Department of Behavioral Sciences & Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA. Electronic address: matthew.howren@med.fsu.edu.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA; Department of Psychological & Brain Sciences, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Christensen', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kaboli', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113244']
1542,32750730,"Efficacy of postoperative oral metronidazole for haemorrhoidectomy pain: a randomized double-blind, placebo-controlled trial.","AIM


The aim of this work was to examine the efficacy of oral metronidazole in reducing posthaemorrhoidectomy pain versus placebo.
METHOD


Forty patients were randomized to either metronidazole and standard care or placebo and standard care (21 metronidazole, 19 placebo) in a double-blinded, randomized controlled trial. The main outcome measure was posthaemorrhoidectomy pain scores over 21 days, measured on a 10-point Likert scale.
RESULTS


There were no significant differences between groups with regards to age, gender, smoking status, self-reported general health or quality of life, haemorrhoid-related pain, haemorrhoid-related impact on quality of life, reported satisfaction with surgery, experience of surgery, median overall pain score or likelihood of recommending surgery to others. For reported median worst pain scores and defaecation-related pain, a trend to significance was identified between groups on days 16 and 18-21, with the metronidazole group reporting less pain. However, these differences were not significant when prespecified Bonferroni correction criteria were used. Using multilevel mixed effects modelling, the impact of time on median worst pain score was identified to be highly significant (P < 0.0001) whereas treatment allocation (placebo versus metronidazole) did not significantly affect the improvement in patients' reported pain (P = 0.8837).
CONCLUSION


Our data do not support the hypothesis that postoperative metronidazole has a clinically meaningful effect on posthaemorrhoidectomy pain. This study adds to the previous literature, and implies that it should not be routinely used as an adjunct to analgesia.",2020,"For reported median worst pain scores and defaecation-related pain, a trend to significance was identified between groups on days 16 and 18-21 with the metronidazole group reporting less pain.","['haemorrhoidectomy pain', 'Forty patients']","['placebo', 'metronidazole', 'metronidazole and standard care or placebo and standard care (21 metronidazole, 19 placebo', 'post-operative oral metronidazole']","['quality of life, reported satisfaction with surgery, experience of surgery, median overall pain score, or likelihood of recommending surgery to others', 'post-haemorrhoidectomy pain scores', 'pain', 'median worst pain score', 'median worst pain scores and defaecation-related pain']","[{'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",40.0,0.678707,"For reported median worst pain scores and defaecation-related pain, a trend to significance was identified between groups on days 16 and 18-21 with the metronidazole group reporting less pain.","[{'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Wilkie', 'Affiliation': 'Department of Surgery, Eastern Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chandra', 'Affiliation': 'Department of Surgery, Eastern Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chua', 'Affiliation': 'Department of Surgery, Eastern Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'D C S', 'Initials': 'DCS', 'LastName': 'Lam', 'Affiliation': 'Department of Surgery, Eastern Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Paratz', 'Affiliation': ""St Vincent's Hospital Melbourne, Fitzroy, Melbourne, Victoria, Australia.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Eastern Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Keck', 'Affiliation': 'Department of Surgery, Eastern Health, Melbourne, Victoria, Australia.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15291']
1543,32751204,HRV-Guided Training for Professional Endurance Athletes: A Protocol for a Cluster-Randomized Controlled Trial.,"Physiological training responses depend on sympathetic (SNS) and parasympathetic nervous system (PNS) balance. This activity can be measured using heart rate variability (HRV). Such a measurement method can favor individualized training planning to improve athletes' performance. Recently, HRV-guided training has been implemented both on professional and amateur sportsmen and sportswomen with varied results. There is a dearth of studies involving professional endurance athletes following a defined HRV-guided training protocol. The objectives of the proposed protocol are: (i) to determine changes in the performance of high-level athletes after following an HRV-guided or a traditional training period and (ii) to determine differences in the athletes' performance after following both training protocols. This will be a 12-week cluster-randomized controlled protocol in which professional athletes will be assigned to an HRV-based training group (HRV-G) or a traditional-based training group (TRAD-G). TRAD-G will train according to a predefined training program. HRV-G training will depend on the athletes' daily HRV. The maximal oxygen uptake (VO 2max ) attained in an incremental treadmill test will be considered as the primary outcome. It is expected that this HRV-guided training protocol will improve functional performance in the high-level athletes, achieving better results than a traditional training method, and thus providing a good strategy for coaches of high-level athletes.",2020,"Recently, HRV-guided training has been implemented both on professional and amateur sportsmen and sportswomen with varied results.","['professional endurance athletes', 'professional athletes', 'Professional Endurance Athletes']","['HRV-based training group (HRV-G) or a traditional-based training group (TRAD-G', 'HRV-G training', 'HRV-Guided Training']","['TRAD', 'functional performance', 'maximal oxygen uptake (VO 2max ', 'sympathetic (SNS) and parasympathetic nervous system (PNS) balance', 'heart rate variability (HRV']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0030510', 'cui_str': 'Parasympathetic nervous system structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0470006,"Recently, HRV-guided training has been implemented both on professional and amateur sportsmen and sportswomen with varied results.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Carrasco-Poyatos', 'Affiliation': 'Department of Education, Health and Public Administration Research Center, University of Almeria, 04120 Almeria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'González-Quílez', 'Affiliation': 'Department of Education, University of Almeria, 04120 Almeria, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Martínez-González-Moro', 'Affiliation': 'Department of Physiotherapy, Physical Exercise and Human Performance Research Group, University of Murcia, 30001 Murcia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Granero-Gallegos', 'Affiliation': 'Department of Education, Health and Public Administration Research Center, University of Almeria, 04120 Almeria, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17155465']
1544,32751340,The Effect of Gaseous Ozone Therapy in Conjunction with Periodontal Treatment on Glycated Hemoglobin Level in Subjects with Type 2 Diabetes Mellitus: An Unmasked Randomized Controlled Trial.,"BACKGROUND


It is established that inflammation is involved in the pathogenesis of Type 2 Diabetes Mellitus (T2DM) by promoting insulin resistance and impaired beta cell function in the pancreas. Among the hypothesized independent risk factors implicated in the pathogenetic basis of disease, periodontal infection has been proposed to promote an amplification of the magnitude of the advanced glycation end product (AGE)-mediated upregulation of cytokine synthesis and secretion. These findings suggest an interrelationship between periodontal disease and type 2 diabetes, describing poor metabolic control in subjects with periodontitis as compared to nondiabetic subjects and more severe periodontitis in subjects with T2DM as compared to a healthy population, with a significant positive correlation between periodontal inflammatory parameters and glycated hemoglobin level. Results from clinical trials show that periodontal treatment is able to improve glycemic control in subjects with diabetes. Many therapeutic strategies have been developed to improve periodontal conditions in conjunction with conventional treatment, among which ozone (O 3 ) is of specific concern. The principal aim of this trial was to compare the clinical effectiveness of an intensive periodontal intervention consisting of conventional periodontal treatment in conjunction with ozone gas therapy in reducing glycated hemoglobin level in type 2 diabetic patients and standard periodontal treatment.
METHODS


This study was a 12-month unmasked randomized trial and included 100 patients aged 40-74 years older, with type 2 diabetes mellitus diagnosed. All the patients received conventional periodontal treatment, or periodontal treatment in conjunction with ozone gas therapy in a randomly assigned order (1:1). The primary outcome was a clinical measure of glycated hemoglobin level at 3, 6, 9 and 12 months from randomization. Secondary outcomes were changes in periodontal inflammatory parameters.
RESULTS


At 12 months, the periodontal treatment in conjunction with ozone gas therapy did not show significant differences than standard therapy in decreasing glycated hemoglobin (HbA1C) level and the lack of significant differences in balance is evident.
CONCLUSIONS


Although the change was not significant, periodontal treatment in conjunction with the gaseous ozone therapy tended to reduce the levels of glycated hemoglobin. The study shows a benefit with ozone therapy as compared to traditional periodontal treatment.",2020,"At 12 months, the periodontal treatment in conjunction with ozone gas therapy did not show significant differences than standard therapy in decreasing glycated hemoglobin (HbA1C) level and the lack of significant differences in balance is evident.
","['Subjects with Type 2 Diabetes Mellitus', 'type 2 diabetic patients and standard periodontal treatment', 'subjects with diabetes', '100 patients aged 40-74 years older, with type 2 diabetes mellitus diagnosed']","['intensive periodontal intervention', 'ozone therapy', 'conventional periodontal treatment', 'ozone gas therapy', 'conventional periodontal treatment, or periodontal treatment in conjunction with ozone gas therapy', 'Periodontal Treatment', 'Gaseous Ozone Therapy']","['glycated hemoglobin level', 'glycated hemoglobin (HbA1C) level', 'changes in periodontal inflammatory parameters', 'severe periodontitis', 'Glycated Hemoglobin Level', 'clinical measure of glycated hemoglobin level', 'levels of glycated hemoglobin', 'glycemic control']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",100.0,0.0391699,"At 12 months, the periodontal treatment in conjunction with ozone gas therapy did not show significant differences than standard therapy in decreasing glycated hemoglobin (HbA1C) level and the lack of significant differences in balance is evident.
","[{'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Rapone', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Complex Operative Unit of Odontostomatology, Hospital S.S. Annunziata, 66100 Chieti, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Corsalini', 'Affiliation': 'Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Converti', 'Affiliation': 'Department of Emergency and Organ Transplantation, Division of Plastic and Reconstructive Surgery, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Felice Roberto', 'Initials': 'FR', 'LastName': 'Grassi', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Santacroce', 'Affiliation': 'Ionian Department (DJSGEM), ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Skender', 'Initials': 'S', 'LastName': 'Topi', 'Affiliation': 'Department of Clinical Disciplines, School of Technical Medical Sciences, University A. Xhuvani, 3001 Elbasan, Albania.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gnoni', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Scacco', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Scarano', 'Affiliation': 'Department of Oral Science, Nano and Biotechnology and CeSi-Met University of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Delvecchio', 'Affiliation': ""Department of Metabolic and Genetic Diseases, Giovanni XXIII Children's Hospital, 70126 Bari, Italy.""}]",International journal of environmental research and public health,['10.3390/ijerph17155467']
1545,32751430,Relief Alternatives during Resuscitation: Instructions to Teach Bystanders. A Randomized Control Trial.,"To analyze the quality of resuscitation (CPR) performed by individuals without training after receiving a set of instructions (structured and unstructured/intuitive) from an expert in a simulated context, the specific objective was to design a simple and structured CPR learning method on-site. An experimental study was designed, consisting of two random groups with a post-intervention measurement in which the experimental group (EG) received standardized instructions, and the control group (CG) received intuitive or non-standardized instructions, in a public area simulated scenario. Statistically significant differences were found ( p  < 0.0001) between the EG and the CG for variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil. The average depth of the EG was 51.1 mm (SD 7.94) and 42.2 mm (SD 12.04) for the CG. The chest recoil median was 86.32% (IQR 62.36, 98.87) for the EG, and 58.3% (IQR 27.46, 84.33) in the CG. The use of a sequence of simple, short and specific orders, together with observation-based learning makes possible the execution of chest compression maneuvers that are very similar to those performed by rescuers, and allows the teaching of the basic notions of ventilation. The structured order method was shown to be an on-site learning opportunity when faced with the need to maintain high-quality CPR in the presence of an expert resuscitator until the arrival of emergency services.",2020,"Statistically significant differences were found ( p  < 0.0001) between the EG and the CG for variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil.",[],"['standardized instructions, and the control group (CG) received intuitive or non-standardized instructions, in a public area simulated scenario']","['chest recoil median', 'average depth of the EG', 'quality of resuscitation (CPR', 'variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil']",[],"[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0205142,"Statistically significant differences were found ( p  < 0.0001) between the EG and the CG for variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil.","[{'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Pujalte-Jesús', 'Affiliation': 'Faculty of Nursing, Universidad Católica de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Leal-Costa', 'Affiliation': 'Faculty of Nursing, University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ruzafa-Martínez', 'Affiliation': 'Faculty of Nursing, University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Antonio Jesús', 'Initials': 'AJ', 'LastName': 'Ramos-Morcillo', 'Affiliation': 'Faculty of Nursing, University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Díaz Agea', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia, 30107 Murcia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17155495']
1546,32751455,Short-Term Resistance Training Supported by Whole-Body Cryostimulation Induced a Decrease in Myostatin Concentration and an Increase in Isokinetic Muscle Strength.,"The study aimed to determine whether combining cryostimulation with resistance training would effectively increase muscle strength, and if so, whether this adaptation would be related to changes in circulating levels of exerkines (i.e., mediators of systemic adaptation to exercise). Twenty-five students completed 12 sessions of resistance training, each followed by either cryostimulation ( n  = 15, 3 min exposure at -110 °C) or passive recovery ( n  = 10). Prior to and post this intervention, participants performed two eccentric cycling bouts (before and after training). At these points, serum concentrations of muscle damage marker (myoglobin), exerkines (interleukin 6 (IL-6), interleukin 15 (IL-15), irisin, brain-derived neurotrophic factor), hypertrophy-related factors (myostatin, insulin-like growth factor 1), and muscle strength were measured. The applied procedure reduced the physiological burden of the second eccentric cycling bout and myoglobin concentrations only in the group subject to cryostimulation. The same group also exhibited decreased levels of myostatin (from 4.7 ± 1.7 to 3.8 ± 1.8 ng·mL -1 ,  p  < 0.05). A significant and large interaction between the group × time was noted in IL-15 concentration ( p  = 0.01, ηp2=0.27). Training and cryostimulation induced a positive and likely significant improvement of isokinetic muscle strength. Altogether, obtained results support the claim that resistance training combined with cold exposure modified muscle strength through modulation of myostatin and IL-15 concentrations.",2020,The applied procedure reduced the physiological burden of the second eccentric cycling bout and myoglobin concentrations only in the group subject to cryostimulation.,[],['resistance training'],"['serum concentrations of muscle damage marker (myoglobin), exerkines (interleukin 6 (IL-6), interleukin 15 (IL-15), irisin, brain-derived neurotrophic factor), hypertrophy-related factors (myostatin, insulin-like growth factor 1), and muscle strength', 'levels of myostatin', 'Myostatin Concentration', 'Isokinetic Muscle Strength', 'isokinetic muscle strength', 'IL-15 concentration']",[],"[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.0218574,The applied procedure reduced the physiological burden of the second eccentric cycling bout and myoglobin concentrations only in the group subject to cryostimulation.,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jaworska', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, Kazimierza Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Rodziewicz-Flis', 'Affiliation': 'Department of Physical Therapy and Biological Regeneration, Gdansk University of Physical Education and Sport, Kazimierza Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Kortas', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sport, Kazimierza Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kozłowska', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, Kazimierza Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Micielska', 'Affiliation': 'Department of Physical Education and Lifelong sports, Poznan University of Physical Education, Krolowej Jadwigi 27/39, 61-871 Poznan, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Babińska', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Medical University, Marii Sklodowskiej-Curie 3, 80-001 Gdansk, Poland.'}, {'ForeName': 'Radosław', 'Initials': 'R', 'LastName': 'Laskowski', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, Kazimierza Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Department of Athletics, Strength and Conditioning, Poznan University of Physical Education, Krolowej Jadwigi 27/39, 61-871 Poznan, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Ziemann', 'Affiliation': 'Department of Athletics, Strength and Conditioning, Poznan University of Physical Education, Krolowej Jadwigi 27/39, 61-871 Poznan, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17155496']
1547,32751720,"Effect of a Six-Week Core Conditioning as a Warm-Up Exercise in Physical Education Classes on Physical Fitness, Movement Capability, and Balance in School-Aged Children.","Whether the implementation of feasible, equipment-free, and simple core exercises in warm-up routines in physical education classes for school-aged children is beneficial remains unclear. Therefore, this study investigated the effects of a core conditioning in the warm-up routine of physical education classes on trunk muscular endurance, movement capability, and flexibility in this population. In these pre- and post-test control group experiments, 52 healthy, school-aged children (aged 10-11 years) were cluster randomized allocated to either the dynamic core exercise (DCE) group or general physical education (GPE) group. The DCE group performed a 10-min core exercise routine twice per week for six consecutive weeks; the GPE group performed traditional physical education warm-up exercises regularly. The children were assessed by conducting the trunk muscular endurance test (i.e., dynamic curl-up, static curl-up, plank, and lateral plank), functional movement screen (FMS), and single-leg balance test before and after the intervention. At the end of the intervention, the DCE group demonstrated a significant effect on trunk muscular endurance, movement capability (i.e., FMS scores), flexibility, and balance (each p < 0.001, effect size: 0.38-1.3). Furthermore, the DCE group showed significant improvements in all outcome measurements compared with the GPE group ( p  < 0.05, effect size: 0.29-1.68). These data may provide a reference for incorporating additional core stability exercises in the warm-up routine of physical education classes in school-aged children in the future.",2020,"Furthermore, the DCE group showed significant improvements in all outcome measurements compared with the GPE group ( p  < 0.05, effect size: 0.29-1.68).","['School-Aged Children', 'school-aged children', '52 healthy, school-aged children (aged 10-11 years']","['dynamic core exercise (DCE) group or general physical education (GPE', 'GPE group performed traditional physical education warm-up exercises regularly', 'DCE', 'GPE']","['trunk muscular endurance, movement capability, and flexibility', 'Physical Fitness, Movement Capability, and Balance', 'trunk muscular endurance, movement capability (i.e., FMS scores), flexibility, and balance']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.036687,"Furthermore, the DCE group showed significant improvements in all outcome measurements compared with the GPE group ( p  < 0.05, effect size: 0.29-1.68).","[{'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'I-Hsien', 'Initials': 'IH', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Chia-Lun', 'Initials': 'CL', 'LastName': 'Lee', 'Affiliation': 'Center for Physical and Health Education, National Sun Yat-sen University, Kaohsiung 804, Taiwan.'}, {'ForeName': 'Chun-Hao', 'Initials': 'CH', 'LastName': 'Liang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17155517']
1548,32751812,Does A Multiple-Sport Intervention Based on the TGfU Pedagogical Model for Physical Education Increase Physical Fitness in Primary School Children?,"Teaching Games for Understanding (TGfU) is one of the pedagogical models used for increasing health through physical education (PE), being associated with several psychological benefits. However, only few studies have studied the effect of TGfU on physical fitness. This study aims at assessing the changes in students' physical fitness after a six-month TGfU-based program with primary school children. A total of eight schools from the state of Sonora (Mexico) were randomly distributed into experimental (EG) and control group (CG). The final sample consisted of 188 pupils (100 boys, 88 girls; age = 10.22 ± 0.76 years) from the 5th and 6th grade. Employing a quasi-experimental design, physical fitness was assessed by means of the Eurofit test battery. At post-test, EG obtained significantly higher scores than CG in flexibility, abdominals, speed ( p  < 0.001), handgrip ( p  = 0.002), low-limb power ( p  = 0.032), and cardiorespiratory fitness ( p  = 0.048). Our findings suggest that TGfU can be a valid alternative to traditional methodologies not only when the aim of a PE unit is to stimulate the cognitive domain, but also for the development of physical fitness attributes that may help pupils develop in a comprehensive manner.",2020,"At post-test, EG obtained significantly higher scores than CG in flexibility, abdominals, speed ( p  < 0.001), handgrip ( p  = 0.002), low-limb power ( p  = 0.032), and cardiorespiratory fitness ( p  = 0.048).","['Primary School Children', ""students' physical fitness after a six-month TGfU-based program with primary school children"", 'A total of eight schools from the state of Sonora (Mexico', '188 pupils (100 boys, 88 girls; age = 10.22 ± 0.76 years) from the 5th and 6th grade']",[],"['low-limb power', 'cardiorespiratory fitness']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",[],"[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",188.0,0.0104797,"At post-test, EG obtained significantly higher scores than CG in flexibility, abdominals, speed ( p  < 0.001), handgrip ( p  = 0.002), low-limb power ( p  = 0.032), and cardiorespiratory fitness ( p  = 0.048).","[{'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Cocca', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Jovanny Edmundo', 'Initials': 'JE', 'LastName': 'Carbajal Baca', 'Affiliation': 'Degree in Sport Training, State University of Sonora, Boulevard Rosales 189, Colonia Centro, 83079 Hermosillo, Mexico.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Hernández Cruz', 'Affiliation': 'School of Sport Organization, Autonomous University of Nuevo Leon, Ciudad Universitaria s/n, 66455 San Nicolás de los Garza, Mexico.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Cocca', 'Affiliation': 'School of Sport Organization, Autonomous University of Nuevo Leon, Ciudad Universitaria s/n, 66455 San Nicolás de los Garza, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17155532']
1549,32752026,Improving Breastfeeding by Empowering Mothers in Vietnam: A Randomised Controlled Trial of a Mobile App.,"Breastfeeding provides benefits to the infant and mother; however, the rates of breastfeeding, particularly exclusive breastfeeding, remain below optimal levels in many Asian countries. The aim of this study is to review the benefits of breastfeeding to mothers and infants and current rates of breastfeeding in Vietnam, and to evaluate the effectiveness of a mobile application on exclusive breastfeeding among mothers in Vietnam. A two-arm, parallel triple-blinded randomised controlled trial will be conducted among 1000 mothers in Hanoi City, Vietnam, during 2020-2021. Eligible participants are pregnant women who will seek antenatal care from health facilities at 24-36 weeks of gestation and plan to deliver at two participating hospitals, own a smartphone, and carry a singleton foetus. Permuted-block randomisation method stratified by maternal age, education and parity will be used to ensure an equal number of participants in each group. A smartphone app will be developed to deliver breastfeeding and non-breastfeeding information to the intervention and control group, respectively. Data will be collected at baseline, before hospital discharge, and at 1, 4, and 6 months postpartum. This study envisages demonstrating whether a smartphone-based intervention can be effective at improving breastfeeding in Vietnam. Trials registration: ACTRN12619000531112.",2020,"Permuted-block randomisation method stratified by maternal age, education and parity will be used to ensure an equal number of participants in each group.","['1000 mothers in Hanoi City, Vietnam, during 2020-2021', 'Eligible participants are pregnant women who will seek antenatal care from health facilities at 24-36 weeks of gestation and plan to deliver at two participating hospitals, own a smartphone, and carry a singleton foetus', 'Empowering Mothers in Vietnam', 'mothers in Vietnam']",['smartphone-based intervention'],[],"[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.142532,"Permuted-block randomisation method stratified by maternal age, education and parity will be used to ensure an equal number of participants in each group.","[{'ForeName': 'Thi Thuy Duong', 'Initials': 'TTD', 'LastName': 'Doan', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Binns', 'Affiliation': 'School of Public Health, Curtin University, Bentley, WA 6102, Australia.'}, {'ForeName': 'Ngoc Minh', 'Initials': 'NM', 'LastName': 'Pham', 'Affiliation': 'School of Public Health, Curtin University, Bentley, WA 6102, Australia.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health, Curtin University, Bentley, WA 6102, Australia.'}, {'ForeName': 'Thi Phuong Hoa', 'Initials': 'TPH', 'LastName': 'Dinh', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Thi Thu Ha', 'Initials': 'TTH', 'LastName': 'Bui', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Trung Chuyen', 'Initials': 'TC', 'LastName': 'Tran', 'Affiliation': 'Faculty of Information Technology, Department of Hanoi University of Mining and Geology, 18 Vien Street-Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Xuan Hoai', 'Initials': 'XH', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of IT, Ho Chi Minh University of Technology (HUTECH), Ho Chi Minh 700000, Vietnam.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Giglia', 'Affiliation': 'Foodbank Perth Airport, Perth, WA 6105, Australia.'}, {'ForeName': 'Fenglian', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Data Analysis & Surgical Outcomes Unit (DASO), Royal North Shore Hospital, St Leonards, NSW 2065, Australia.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}]",International journal of environmental research and public health,['10.3390/ijerph17155552']
1550,32752077,Parental Opinion about the Low FODMAP Diet in Dietary Treatment of Children with Functional Abdominal Pain.,"The aim of this study was primarily to evaluate differences between parental opinion about the diet and overall changes in children's symptoms of functional abdominal pain (FAP) during the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet and National Institute for Health and Care Excellence (NICE) diet. Secondly, this paper examined the agreement between parental perception of children's symptoms and children's self-assessment of symptoms during the diet in both treatment groups. Twenty-seven children with diagnosed functional abdominal pain (FAP) were randomized to one of two group, receiving the low FODMAP diet or the diet based on NICE guidelines. Children reported gastrointestinal symptoms at baseline and during the diet. At the end of the intervention, parents assessed their children's diet and symptoms changes, using Likert scales. The agreement between parental and children assessments of gastrointestinal symptoms was defined as the percentage of compatible answers. In the low FODMAP group a significantly lower percentage of parents (38%) declared that it was easy to follow the diet, compared to the NICE group (57%), ( p  = 0.017). A high percentage of parents in both groups reported improvement in all symptoms of children during dietary intervention. A high level of agreement was also observed between parental and children's self-assessment of abdominal pain intensity and frequency. Our research suggests that in parental opinion the low FODMAP diet is as effective as the diet based on NICE guidelines in children with FAP. However, the low FODMAP diet may seem more difficult to follow, and this may have had an impact on the effectiveness and acceptability of the FODMAP diet by children.",2020,A high level of agreement was also observed between parental and children's self-assessment of abdominal pain intensity and frequency.,"['children with FAP', 'Children with Functional Abdominal Pain', 'Twenty-seven children with diagnosed functional abdominal pain (FAP']","['low FODMAP diet or the diet based on NICE guidelines', 'Low FODMAP Diet']","['functional abdominal pain (FAP', 'gastrointestinal symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",27.0,0.0139782,A high level of agreement was also observed between parental and children's self-assessment of abdominal pain intensity and frequency.,"[{'ForeName': 'Katarzyna Mirosława', 'Initials': 'KM', 'LastName': 'Boradyn', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Sciences, University of Warmia and Mazury in Olsztyn, Słoneczna 45F, 10-718 Olsztyn, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Jarocka-Cyrta', 'Affiliation': 'Department of Pediatrics, Gastroenterology and Nutrition, Faculty of Medicine Collegium Medicum, University of Warmia and Mazury in Olsztyn, Żołnierska 18A, 10-561 Olsztyn, Poland.'}, {'ForeName': 'Katarzyna Eufemia', 'Initials': 'KE', 'LastName': 'Przybyłowicz', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Sciences, University of Warmia and Mazury in Olsztyn, Słoneczna 45F, 10-718 Olsztyn, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Obara-Gołębiowska', 'Affiliation': 'Department of Clinical, Developmental and Educational Psychology, Faculty of Social Sciences, University of Warmia and Mazury in Olsztyn, Prawocheńskiego 13, 10-447 Olsztyn, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17155554']
1551,32752228,Benefits of Brief Group Cognitive Behavioral Therapy in Reducing Diabetes-Related Distress and HbA1c in Uncontrolled Type 2 Diabetes Mellitus Patients in Thailand.,"This study evaluated the short-term efficacy of brief group cognitive behavioral therapy (BG-CBT) in reducing diabetes-related distress (DRD), lowering hemoglobin A1c (HbA1c), improving food consumption behavior, increasing physical activity, and improving medication adherence behavior. A quasi-experimental pretest/post-test design with follow-up assessments was used with an experimental and a control group. Participants were patients with uncontrolled type 2 diabetes mellitus (T2DM) and moderate or high diabetes-related distress recruited from the Diabetes Mellitus Clinic of Hang Dong Hospital, Chiang Mai, Thailand. Fifty-six eligible participants were purposively selected and enrolled, then randomly assigned to either the BG-CBT group or the control group. The BG-CBT group received six brief weekly sessions of cognitive behavioral group therapy, while the control group received conventional care. Baseline data were collected at week 0 (pretest) and at week 6 (post-test), including food consumption behavior, physical activity, and adherence to medication regimes, as well as a blood examination to determine levels of HbA1c at the week 12 follow-up. DRD was assessed using the Diabetes Distress Scale (DDS-17) and analyzed using descriptive statistics, including pair t-test and independence t-test results. The BG-CBT had a significant effect on the amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels, demonstrating the effectiveness of BG-CBT in maintaining diabetes control in people with T2DM-related distress.",2020,"The BG-CBT had a significant effect on the amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels, demonstrating the effectiveness of BG-CBT in maintaining diabetes control in people with T2DM-related distress.","['Participants were patients with uncontrolled type 2 diabetes mellitus (T2DM) and moderate or high diabetes-related distress recruited from the Diabetes Mellitus Clinic of Hang Dong Hospital, Chiang Mai, Thailand', 'Uncontrolled Type 2 Diabetes Mellitus Patients in Thailand', 'Fifty-six eligible participants']","['brief group cognitive behavioral therapy (BG-CBT', 'cognitive behavioral group therapy, while the control group received conventional care', 'BG-CBT', 'Brief Group Cognitive Behavioral Therapy']","['diabetes-related distress (DRD), lowering hemoglobin A1c (HbA1c), improving food consumption behavior, increasing physical activity, and improving medication adherence behavior', 'Diabetes Distress Scale (DDS-17', 'DRD', 'amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels', 'food consumption behavior, physical activity, and adherence to medication regimes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",56.0,0.0198252,"The BG-CBT had a significant effect on the amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels, demonstrating the effectiveness of BG-CBT in maintaining diabetes control in people with T2DM-related distress.","[{'ForeName': 'Kongprai', 'Initials': 'K', 'LastName': 'Tunsuchart', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Peerasak', 'Initials': 'P', 'LastName': 'Lerttrakarnnon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Kriengkrai', 'Initials': 'K', 'LastName': 'Srithanaviboonchai', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Surinporn', 'Initials': 'S', 'LastName': 'Likhitsathian', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Sombat', 'Initials': 'S', 'LastName': 'Skulphan', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Nursing, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17155564']
1552,32752234,The Effectiveness of Individual or Group Physiotherapy in the Management of Sub-Acromial Impingement: A Randomised Controlled Trial and Health Economic Analysis.,"Background : Shoulder pain is common in primary care. The management of subacromial impingement (SAI) can include corticosteroid injections and physiotherapy. Physiotherapy can be on an individual or group basis.  Aim : To examine the clinical effectiveness and make an economic analysis of individual versus group physiotherapy, following corticosteroid injection for SAI.  Design and Setting : A single-blind, open-label, randomised equivalence study comparing group and individual physiotherapy. Patients referred by local general practitioners and physiotherapists were considered for inclusion.  Method : Patients were randomised to individual or group physiotherapy groups, and all received corticosteroid injection before physiotherapy. The primary outcome measure was shoulder pain and disability index (SPADI) at 26 weeks. An economic analysis was conducted.  Results and Conclusion : 136 patients were recruited, 68 randomised to each group. Recruitment was 68% of the target 200 participants. SPADI (from baseline to 26 weeks) demonstrated a difference (SE) in mean change between groups of -0.43 (5.7) ( p -value = 0.050001), and the TOST (two-one-sided test for equivalence) 90% CI for this difference was (-10.0 to 9.14). This was borderline. In a secondary analysis using inputted data, patients without SPADI at week 26 were analysed by carrying forward scores at week 12 (mean difference (95% CI) = -0.14 (-7.5 to 7.3),  p -value = 0.014). There is little difference in outcome at 26 weeks. Group physiotherapy was cheaper to deliver per patient (£252 versus £84). Group physiotherapy for SAI produces similar clinical outcomes to individual physiotherapy with potential cost savings. Due to low recruitment to our study, firm conclusions are difficult and further research is required to give a definitive answer to this research question. (NCT Clinical Trial Registration Number NCT04058522).",2020,Group physiotherapy was cheaper to deliver per patient (£252 versus £84).,"['Sub-Acromial Impingement', '136 patients were recruited, 68 randomised to each group', 'Patients referred by local general practitioners and physiotherapists were considered for inclusion']","['corticosteroid injection before physiotherapy', 'subacromial impingement (SAI', 'Individual or Group Physiotherapy', 'corticosteroid injections and physiotherapy']","['shoulder pain and disability index (SPADI', 'TOST', 'SPADI']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4704938', 'cui_str': 'Group Physiotherapy'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.232029,Group physiotherapy was cheaper to deliver per patient (£252 versus £84).,"[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ryans', 'Affiliation': 'General Practice Elective Care Service (MSK), Eastern GP Federations, Belfast, BT8 7AR, Ireland.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'Galway', 'Affiliation': 'Rheumatology Department, South Eastern Health and Social Services Trust, Dundonald BT16 1RH, Ireland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Harte', 'Affiliation': 'School of Health Sciences, Ulster University, Belfast BT37 0QB, Ireland.'}, {'ForeName': 'Rejina', 'Initials': 'R', 'LastName': 'Verghis', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast BT12 6BA, Ireland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast BT12 6BA, Ireland.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Heron', 'Affiliation': ""Department of General Practice, Queen's University Belfast, Belfast BT7 1NN, UK.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'McKane', 'Affiliation': 'Rheumatology Department, South Eastern Health and Social Services Trust, Dundonald BT16 1RH, Ireland.'}]",International journal of environmental research and public health,['10.3390/ijerph17155565']
1553,32752306,Thermotherapy Plus Neck Stabilization Exercise for Chronic Nonspecific Neck Pain in Elderly: A Single-Blinded Randomized Controlled Trial.,"Neck pain is a serious problem for public health. This study aimed to compare the effects of thermotherapy plus neck stabilization exercise versus neck stabilization exercise alone on pain, neck disability, muscle properties, and alignment of the neck and shoulder in the elderly with chronic nonspecific neck pain. This study is a single-blinded randomized controlled trial. Thirty-five individuals with chronic nonspecific neck pain were randomly allocated to intervention ( n  = 18) or control ( n  = 17) groups. The intervention group received thermotherapy with a salt-pack for 30 min and performed a neck stabilization exercise for 40 min twice a day for 5 days (10 sessions). The control group performed a neck stabilization exercise at the same time points. Pain intensity, pain pressure threshold (PPT), neck disability index, muscle properties, and alignment of the neck and shoulder were evaluated before and after the intervention. Significant time and group interactions were observed for pain at rest ( p  < 0.001) and during movement ( p  < 0.001), and for PPT at the upper-trapezius ( p  < 0.001), levator-scapula ( p  = 0.003), and splenius-capitis ( p  = 0.001). The disability caused by neck pain also significantly changed between groups over time ( p  = 0.005). In comparison with the control group, the intervention group showed significant improvements in muscle properties for the upper-trapezius (tone,  p  = 0.021; stiffness,  p  = 0.017), levator-scapula (stiffness,  p  = 0.025; elasticity,  p  = 0.035), and splenius-capitis (stiffness,  p  = 0.012), and alignment of the neck ( p  = 0.016) and shoulder ( p  < 0.001) over time. These results recommend the clinical use of salt pack thermotherapy in addition to neck stabilization exercise as a complementary intervention for chronic nonspecific neck pain control.",2020,"Significant time and group interactions were observed for pain at rest ( p  < 0.001) and during movement ( p  < 0.001), and for PPT at the upper-trapezius ( p  < 0.001), levator-scapula ( p  = 0.003), and splenius-capitis ( p  = 0.001).","['elderly with chronic nonspecific neck pain', 'chronic nonspecific neck pain control', 'Thirty-five individuals with chronic nonspecific neck pain', 'Chronic Nonspecific Neck Pain in Elderly']","['thermotherapy plus neck stabilization exercise versus neck stabilization exercise alone', 'neck stabilization exercise', 'Thermotherapy Plus Neck Stabilization Exercise', 'thermotherapy with a salt-pack for 30 min and performed a neck stabilization exercise']","['pain, neck disability, muscle properties, and alignment of the neck and shoulder', 'Pain intensity, pain pressure threshold (PPT), neck disability index, muscle properties, and alignment of the neck and shoulder', 'muscle properties for the upper-trapezius', 'pain at rest', 'disability caused by neck pain', 'levator-scapula']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0231493', 'cui_str': 'Muscle property'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}]",35.0,0.064528,"Significant time and group interactions were observed for pain at rest ( p  < 0.001) and during movement ( p  < 0.001), and for PPT at the upper-trapezius ( p  < 0.001), levator-scapula ( p  = 0.003), and splenius-capitis ( p  = 0.001).","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Suk-Chan', 'Initials': 'SC', 'LastName': 'Hahm', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17155572']
1554,32753571,Are There Lower Complication Rates with Bidirectional Barbed Suture in Total Knee Arthroplasty Incision Closure? A Randomized Clinical Trial.,"BACKGROUND The use of barbed suture in total knee arthroplasty (TKA) remains controversial. We performed a prospective study to investigate the clinical outcomes of bidirectional barbed suture for incision closure in TKA. MATERIAL AND METHODS We conducted a single-center, randomized controlled trial to determine the efficiency and safety of barbed suture in TKA at our institution between December 2017 and April 2019. Eligible patients were randomly assigned to different suture methods for skin closure. Randomization was conducted via computerized randomization list. Our primary endpoint was the incidence of wound complications within 3 months of surgery. This trial was registered at ClinicalTrials.gov, number ChiCTR-IPR-17013677. RESULTS A total of 582 patients were enrolled, consisting of 193 who received full-layer barbed suture (group A), 195 who received barbed suturing of the joint capsule (group B), and 194 who received suturing of the joint capsule by traditional absorbable suture (group C). The incidence of incision complications in group A (19.7%) was significantly higher than that in group B (7.2%) and C (9.3%) (P<0.0125). The incidence rate for incision complications in group B was similar to that in group C (P>0.0125). The time for incision closure in groups A (13.5±2.0 min) and B (16.1±1.9 min) was significantly shorter than that in group C (25.0±2.0 min) (P<0.001). CONCLUSIONS The use of full-thickness bidirectional barbed suture for incision closure after TKA may increase postoperative incision complications, and therefore is not recommended. However, the use of barbed suture for the joint capsule has shown effectiveness, reducing suture time with no increase in incision complications.",2020,The incidence rate for incision complications in group B was similar to that in group C (P>0.0125).,"['total knee arthroplasty (TKA', 'at our institution between December 2017 and April 2019', 'Eligible patients', '582 patients were enrolled, consisting of 193 who received']","['barbed suturing of the joint capsule', 'suturing of the joint capsule by traditional absorbable suture', 'bidirectional barbed suture for incision closure in TKA', 'suture methods for skin closure', 'barbed suture', 'Bidirectional Barbed Suture', 'full-thickness bidirectional barbed suture for incision closure after TKA', 'barbed suture in TKA', 'full-layer barbed suture']","['suture time', 'efficiency and safety', 'incidence rate for incision complications', 'incidence of wound complications', 'incision complications', 'postoperative incision complications', 'time for incision closure', 'incidence of incision complications', 'Complication Rates']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",582.0,0.205795,The incidence rate for incision complications in group B was similar to that in group C (P>0.0125).,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Postgraduate Department, Harbin Medical University, Harbin, Heilongjiang, China (mainland).'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Guo-Chun', 'Initials': 'GC', 'LastName': 'Zha', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922783']
1555,31611625,The relative importance of factors predicting outcome for myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial.,"Disease factors such as tumor burden and molecular risk affect myeloma patient outcomes as well as patient factors that impact the capacity to deliver treatment. How the relative importance of these factors changes with patient age has not previously been investigated comprehensively. We analyzed data from 3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI. Even with novel therapeutic approaches progression-free survival (PFS) and overall survival (OS) are affected by age with a stepwise reduction in PFS and OS with each decade increase. Renal function deteriorated with increasing age whilst the frequency of t(4;14) and del(17p) decreased and gain(1q) increased. The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group. Molecular events have a larger effect on outcome in younger patients with their relative contribution diminishing in the elderly. Performance status is important for patient outcome at all ages suggesting that physical frailty may be a more important predictor of outcome than age itself. Significant differences in the factors driving patient outcomes at different ages are important to consider as we design disease segmentation strategies to deliver personalized treatment approaches.",2020,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","['myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial', 'younger patients with their relative contribution diminishing in the elderly', '3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI']",[],"['relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0547204,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK. charlotte.pawlyn@icr.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vallari', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Section of Experimental Haematology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}]",Leukemia,['10.1038/s41375-019-0595-5']
1556,32756078,The effect of Sancai powder on glycemic variability of type 2 diabetes in the elderly: A randomized controlled trial.,"BACKGROUND


Type 2 diabetes is a kind of metabolic disease. Its clinical characteristic is hyperglycemia. Recently, more and more elderly people suffer from type 2 diabetes, and the glycemic variability of the elderly is greater. In addition, blood sugar variation is more likely to cause diabetes complications than simple hyperglycemia. Sancai podwer (SC) is based on the theory of traditional Chinese medicine and gradually formed in the summary of clinical experience. It has the effect of lowering blood sugar and alleviating clinical symptoms of diabetes. But the existing evidence of its efficacy on glycemic variability is insufficient. So, in our study, the randomized controlled trials will be used as a research method to explore the effects of SC on glycemic variability of type 2 diabetes.
METHOD


We will use randomized controlled experiments based on the recommended diagnostic criteria, inclusion and exclusion criteria. A total of 60 elderly patients with type 2 diabetes will be randomly divided into treatment group and control group, 30 cases in each group. The control group will receive conventional western medicine and the intervention group will receive SC combined with western medicine. The standard deviation and coefficient of variation of blood glucose level will be used as evaluation indexes.
DISCUSSION


This study can provide evidence for the clinical efficacy and safety of SC in elderly patients with type 2 diabetes mellitus.
TRIAL REGISTRATION


This study is registered on the Chinese Clinical Trial Registry: ChiCTR2000032611.",2020,Sancai podwer (SC) is based on the theory of traditional Chinese medicine and gradually formed in the summary of clinical experience.,"['type 2 diabetes in the elderly', 'elderly patients with type 2 diabetes mellitus', '60 elderly patients with type 2 diabetes']","['Sancai podwer (SC', 'Sancai powder', 'conventional western medicine and the intervention group will receive SC combined with western medicine', 'SC']","['standard deviation and coefficient of variation of blood glucose level', 'glycemic variability']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",60.0,0.0609136,Sancai podwer (SC) is based on the theory of traditional Chinese medicine and gradually formed in the summary of clinical experience.,"[{'ForeName': 'Dongqi', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Xuke', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020750']
1557,32756081,Study on preventing adverse events in neonates (SEPREVEN): A stepped-wedge randomised controlled trial to reduce adverse event rates in the NICU.,"INTRODUCTION


Adverse events (AE) in care are recognized as a leading cause of mortality and injury in patients. Improving patients' safety is difficult to achieve. Therefore, innovative research strategies are needed to identify errors in subgroups of patients and related severity of outcomes as well as reliably measured efficiency of reproducible strategies to improve safety. This trial aims to evaluate the impact of a combined multiprofessional education program on the rate of AE in neonatal intensive care units (NICUs).
METHODS AND ANALYSIS


This is a stepped-wedge cluster randomised controlled trial with 3 clusters each containing 4 units. The study time period will be 20 months. The education program will be implemented within each cluster following a random sequence with a control period, a 4-month transition period and a post-educational intervention period. Eligibility criteria: for clusters: 6 NICUs from Ile-de-France and 6 NICUs from different regions in France; for patients: in-hospital during the study period (November 23, 2015 and November 2, 2017 [inclusion start dates varying by unit]) in one of the 12 NICUs; corrected gestational age ≤42 weeks upon admission; hospitalization period >2 days; and parents informed and not opposed to the use of their newborn's data. A routine occurrence reporting of medical errors and their consequence will take place during the entire study period. The intervention will combine an education to implement a standardized root cause analysis method, creation of bundles (insertion, daily goals, maintenance bundles) to prevent catheter-associated blood-stream infection and a poster to prevent extravasation injuries.
OUTCOME


We hypothesize a reduction from 60 (control) to 50 (intervention) AE/1000 patient-days. The primary outcome will be the rate of AE/1000 patient-days in the NICU.
TRIAL REGISTRATION NUMBER


NCT02598609, trial registered November 6, 2015. https://clinicaltrials.gov/ct2/show/NCT02598609.
ETHICS AND DISSEMINATION


Study approved by the regional ethic committee CPP Ile-de-France III (no 2014-A01751-46). The results will be published in peer-reviewed journals.",2020,"This trial aims to evaluate the impact of a combined multiprofessional education program on the rate of AE in neonatal intensive care units (NICUs).
","[""Eligibility criteria: for clusters: 6 NICUs from Ile-de-France and 6 NICUs from different regions in France; for patients: in-hospital during the study period (November 23, 2015 and November 2, 2017 [inclusion start dates varying by unit]) in one of the 12 NICUs; corrected gestational age ≤42 weeks upon admission; hospitalization period >2 days; and parents informed and not opposed to the use of their newborn's data"", 'neonates (SEPREVEN', 'neonatal intensive care units (NICUs']",['combined multiprofessional education program'],"['adverse event rates', 'rate of AE', 'rate of AE/1000\u200apatient-days in the NICU', 'adverse events']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]",,0.170506,"This trial aims to evaluate the impact of a combined multiprofessional education program on the rate of AE in neonatal intensive care units (NICUs).
","[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Caeymaex', 'Affiliation': 'Faculty of Health and CEDITEC, University Paris East Creteil.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Lebeaux', 'Affiliation': 'Neonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Creteil.'}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Roze', 'Affiliation': 'Pediatric Intensive Care Unit Nantes, University Hospital Centre Nantes, Pays de la Loire.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Danan', 'Affiliation': 'Neonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Creteil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Reynaud', 'Affiliation': 'Association SOS Prema, Boulogne Billancourt.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Clinical Research Center (CRC), Centre Hospitalier Intercommunal de Creteil, Créteil.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Audureau', 'Affiliation': 'Faculty of Health and CEDITEC, University Paris East Creteil.'}]",Medicine,['10.1097/MD.0000000000020912']
1558,32756124,A randomized study protocol of microendoscopic versus open discectomy in treatment of lumbar disc herniation.,"BACKGROUND


Lumbar disk herniation (LDH) is one of the main causes of discogenic low back pain. However, the evidence comparing different approaches for discectomy has lacked definitive conclusions, with conflicting results regarding the benefit of minimally invasive versus open techniques for LDH. We are now conducting a randomized controlled trial to figure out whether or not microendoscopic discectomy yields better clinical outcomes and causes less surgical trauma than open surgery.
METHODS


This prospective, randomized, single-blind, controlled, superiority clinical trial was approved by the institutional review board in the People's Hospital of Jianyang City. The conduct of this study followed the Declaration of Helsinki principles and the reporting of this study adhered to the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials. Subjects were randomized into 2 groups as follows: open surgery and microendoscopic group. The outcomes included pain score, functional outcome, satisfaction rate, radiological outcomes, and complications. The statistical analyses in this study were performed using the Statistical Package for the Social Sciences 20.0 software. P < .05 was accepted as statistically significant.
RESULTS


The hypothesis was that the open technique would achieve similar clinical outcomes as compared to the microendoscopic technique in LDH.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5708).",2020,"We are now conducting a randomized controlled trial to figure out whether or not microendoscopic discectomy yields better clinical outcomes and causes less surgical trauma than open surgery.
","['lumbar disc herniation', ""People's Hospital of Jianyang City""]","['open surgery and microendoscopic group', 'microendoscopic versus open discectomy']","['pain score, functional outcome, satisfaction rate, radiological outcomes, and complications']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.132044,"We are now conducting a randomized controlled trial to figure out whether or not microendoscopic discectomy yields better clinical outcomes and causes less surgical trauma than open surgery.
","[{'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Leshan.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, the Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lei', 'Affiliation': 'Department of Orthopedics, the Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Leshan.""}, {'ForeName': 'Xufeng', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': ""Department of Orthopedics, The People's Hospital of Jianyang City, Sichuan Province, China.""}]",Medicine,['10.1097/MD.0000000000021361']
1559,32756176,"Effects of Yangxinshi tablet on exercise tolerance in patients with coronary heart disease: A protocol of randomized, double-blind, placebo-controlled, and multi-center trial.","BACKGROUND


Exercise intolerance is very common in patients with coronary heart disease (CHD). Although some researches confirming the validation of traditional Chinese medicine (TCM) on CHD treatment, the effect of TCM on improving the exercise tolerance of patients with CHD remains unclear so far. Our trial is to investigate whether the Yangxinshi (YXS) tablet can improve exercise tolerance as well as the quality of life among CHD patients.
METHODS


It is a randomized, double-blind, placebo-controlled, multi-center trial. A total of 90 patients with CHD from 3 hospitals in China will be enrolled and randomly assigned to one of 2 groups: YXS group, N = 45; placebo group, N = 45. The 2 groups will simultaneously receive standardized western medicine and exercise-based cardiac rehabilitation program for 12 weeks. The primary outcome measure is the exercise capacity, which will be evaluated by the cardiopulmonary exercise test and 6-minute walking test. The 2nd outcomes include symptom improvement, psychologic issues, laboratory tests, side effects, and adverse events.
DISCUSSION


To our knowledge, it is the 1st randomized controlled trial to evaluate the effect of TCM YXS tablet on exercise tolerance in patients with CHD. The results will provide more evidence for future studies in this area.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5752).",2020,"Our trial is to investigate whether the Yangxinshi (YXS) tablet can improve exercise tolerance as well as the quality of life among CHD patients.
","['90 patients with CHD from 3 hospitals in China', 'patients with coronary heart disease (CHD', 'patients with coronary heart disease', 'CHD patients', 'patients with CHD']","['Yangxinshi (YXS) tablet', 'Yangxinshi tablet', 'TCM', 'TCM YXS tablet', 'YXS group, N\u200a=\u200a45; placebo', 'standardized western medicine and exercise-based cardiac rehabilitation program', 'traditional Chinese medicine (TCM', 'placebo']","['symptom improvement, psychologic issues, laboratory tests, side effects, and adverse events', 'exercise tolerance', 'exercise capacity, which will be evaluated by the cardiopulmonary exercise test and 6-minute walking test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C4742319', 'cui_str': 'Yangxinshi tablet'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C4742318', 'cui_str': 'Yangxinshi'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",90.0,0.531614,"Our trial is to investigate whether the Yangxinshi (YXS) tablet can improve exercise tolerance as well as the quality of life among CHD patients.
","[{'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Zhijia', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Operating Room Department, Feicheng Mining Bureau Central Hospital, Tai'an City, Shandong Province, China.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}]",Medicine,['10.1097/MD.0000000000021485']
1560,32756180,Th17/Treg imbalance in patients with severe acute pancreatitis: Attenuated by high-volume hemofiltration treatment.,"BACKGROUND


To investigate the effect of high-volume hemofiltration (HVHF) on Th17/Treg imbalance in patients with severe acute pancreatitis (SAP).
METHODS


Forty-two patients with SAP were randomly received 24 hours of continuous HVHF (n = 21) or without HVHF (n = 21). At day 28, all 42 patients were divided into survival group (n = 32) and non-survival group (n = 10). Venous blood samples collected at 0, 6, 12, and 24 hours during HVHF treatment (or equivalent time in non-HVHF group) were assessed by flow cytometry to detect Th17 and Treg cells. Concentrations of IL-6, IL-17, IL-10, and TGF-β1 were detected by enzyme-linked immunosorbent assay.
RESULTS


Th17%, Treg%, Th17/Treg, and levels of related cytokines were significantly higher in SAP patients than healthy controls (P < .05), and these changes were more pronounced in SAP patients with multiple organ failure than those with single organ failure (P < .05). After HVHF treatment, Th17%, Treg%, Th17/Treg, IL-6, IL-17, and IL-10 significantly reduced (P < .05), while there were no significant changes in non-HVHF group (P > .05). In addition, acute physiology and chronic health evaluation II and sequential organ failure assessment scores decreased markedly after HVHF treatment. Baselines of Th17%, Treg%, Th17/Treg, and related cytokines were significantly higher in non-survival group than survival group. Both acute physiology and chronic health evaluation I score and IL-6 level were positively correlated with Th17% before and after HVHF treatment (P < .01).
CONCLUSIONS


Th17/Treg imbalance is present in SAP and may be correlated with its severity and prognosis. HVHF effectively attenuates the Th17/Treg imbalance in SAP patients. The beneficial effect of HVHF on Th17/Treg imbalance is possibly associated with removing excess inflammatory mediators.",2020,"After HVHF treatment, Th17%, Treg%, Th17/Treg, IL-6, IL-17, and IL-10 significantly reduced (P < .05), while there were no significant changes in non-HVHF group (P > .05).","['Forty-two patients with SAP', 'patients with severe acute pancreatitis', 'SAP patients', 'patients with severe acute pancreatitis (SAP']","['high-volume hemofiltration (HVHF', 'HVHF', 'continuous HVHF (n\u200a=\u200a21) or without HVHF']","['Treg%, Th17/Treg, and levels of related cytokines', 'acute physiology and chronic health evaluation I score and IL-6 level', 'Treg%, Th17/Treg, IL-6, IL-17, and IL-10', 'Th17/Treg imbalance', 'Concentrations of IL-6, IL-17, IL-10, and TGF-β1', 'acute physiology and chronic health evaluation II and sequential organ failure assessment scores', 'Treg%, Th17/Treg, and related cytokines']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019014', 'cui_str': 'Hemofiltration'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",42.0,0.0236775,"After HVHF treatment, Th17%, Treg%, Th17/Treg, IL-6, IL-17, and IL-10 significantly reduced (P < .05), while there were no significant changes in non-HVHF group (P > .05).","[{'ForeName': 'Jiguang', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Nephrology,People's Hospital of Rongchang District.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Yongchuan Hospital of Chongqing Medical University.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, Yongchuan Hospital of traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Yongchuan Hospital of Chongqing Medical University.'}]",Medicine,['10.1097/MD.0000000000021491']
1561,32756204,A study on respiratory management in acute postoperative period by nasal high flow for patients undergoing surgery under general anesthesia.,"In head and neck surgery where the oropharyngeal area is the operative field, postoperative respiratory depression and upper airway obstruction are common. Therefore, supplemental oxygen is administered to prevent severe postoperative early hypoxemia. However, a high concentration of oxygen increases the likelihood of secondary complications, such as carbon dioxide (CO2) narcosis. Nasal high-flow (NHF) therapy generates high flows (≤60 L/min) of heated and humidified gas delivered via nasal cannula and provides respiratory support by generating positive airway pressure, clearance of dead space and reduction of work of breathing. This study aims to determine whether the postoperative hypoxemia and hypercapnia can be prevented by NHF without the requirement of supplemental oxygen. The study will recruit adult patients undergoing planned oral surgery under general anesthesia at Nagasaki University Hospital. It is a randomized parallel group comparative study with 3 groups: NHF with room air only and no supplemental oxygen, no respiratory support, and face mask oxygen administration. The study protocol will begin at the time that the patient is returned to the general ward and will finish 3 hours later. The primary endpoint is the time-weighted average of transcutaneous O2 over the 180 minutes and secondary endpoints are the time-weighted average of transcutaneous CO2 (tcpCO2), SpO2, and respiratory rate, incidence rate of marked hypercapnia (tcpCO2 ≥60 mm Hg for 5 minutes or longer), incidence rate of moderate hypercapnia (tcpCO2 ≥50 mm Hg for 5 minutes or longer) and the percentage of time that SpO2 is <90%. Included also is a group in which the postoperative management is performed only by spontaneous breathing without performing respiratory support such as oxygen administration, to investigate the efficacy and necessity of conventional oxygen administration. This exploratory study will investigate the use of NHF without supplemental oxygen as an effective respiratory support during the acute postoperative period. TRIAL REGISTRATION:: The study was registered the jRCTs072200018. URL https://jrct.niph.go.jp/latest-detail/jRCTs072200018.",2020,"Nasal high-flow (NHF) therapy generates high flows (≤60 L/min) of heated and humidified gas delivered via nasal cannula and provides respiratory support by generating positive airway pressure, clearance of dead space and reduction of work of breathing.","['patients undergoing surgery under general anesthesia', 'adult patients undergoing planned oral surgery under general anesthesia at Nagasaki University Hospital']","['Nasal high-flow (NHF) therapy', 'NHF without supplemental oxygen', 'NHF with room air only and no supplemental oxygen, no respiratory support, and face mask oxygen administration']","['carbon dioxide (CO2) narcosis', 'positive airway pressure, clearance of dead space and reduction of work of breathing', 'time-weighted average of transcutaneous O2', 'time-weighted average of transcutaneous CO2 (tcpCO2), SpO2, and respiratory rate, incidence rate of marked hypercapnia (tcpCO2 ≥60 mm Hg for 5 minutes or longer), incidence rate of moderate hypercapnia (tcpCO2 ≥50 mm Hg for 5 minutes or longer) and the percentage of time that SpO2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0221340', 'cui_str': 'Carbon dioxide narcosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C1318131', 'cui_str': 'TcPCO2'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0988491,"Nasal high-flow (NHF) therapy generates high flows (≤60 L/min) of heated and humidified gas delivered via nasal cannula and provides respiratory support by generating positive airway pressure, clearance of dead space and reduction of work of breathing.","[{'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Sekino', 'Affiliation': 'Division of Intensive Care.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher and Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher and Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Dental Anesthesiology.'}]",Medicine,['10.1097/MD.0000000000021537']
1562,32756313,Energy Intake and Satiety Responses of Eggs for Breakfast in Overweight and Obese Adults-A Crossover Study.,"The type of food eaten for breakfast may determine the amount of food consumed at the next meal. This may be important when considering dietary advice for overweight and obese individuals who are trying to lose weight. The aim of the study was to investigate the energy intake and subjective sensations of hunger using a visual analogue scale (VAS) of a breakfast meal of eggs compared with a breakfast meal of cereal in overweight Australian adults. In a cross-over study, participants attended the University of South Australia's Clinical Trial Facility on two separate days, one week apart. On each day participants consumed one of two isoenergetic breakfasts (1800 kJ), either eggs and toast or cereal with milk and orange juice. Fifty overweight or obese participants, 44 ± 21 years, 86 ± 14 kg, with a body mass index (BMI) of 31 ± 4 kg/m 2  completed both study visits. Energy intake following the egg breakfast was significantly reduced compared with the cereal breakfast (4518 vs. 5283 kJ,  p  = 0.001). BMI and gender were unrelated to these effects. The sensation of hunger was less after the egg breakfast ( p  = 0.028 for diet by time interaction) and returned more quickly after the cereal breakfast. There were no effects of gender or age. Energy intake was reduced at an ad libitum lunch meal 4 hours after a breakfast meal containing eggs. The findings suggest that satiety responses of overweight and obese are not different to non-obese participants as our study confirms findings from studies conducted in different populations. Determining which foods may help overweight and obese individuals manage their food intake is important for diet planning.",2020,The sensation of hunger was less after the egg breakfast ( p  = 0.028 for diet by time interaction) and returned more quickly after the cereal breakfast.,"[""participants attended the University of South Australia's"", 'Eggs for Breakfast in Overweight and Obese Adults', 'overweight Australian adults', 'overweight and obese individuals who are trying to lose weight', 'Fifty overweight or obese participants, 44 ± 21 years, 86 ± 14 kg, with a body mass index (BMI) of 31 ± 4 kg/m 2  completed both study visits']","['hunger using a visual analogue scale (VAS) of a breakfast meal of eggs compared with a breakfast meal of cereal', 'isoenergetic breakfasts (1800 kJ), either eggs and toast or cereal with milk and orange juice']","['Energy intake', 'sensation of hunger', 'Energy Intake and Satiety Responses']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036240', 'cui_str': 'Satiety Response'}]",,0.0627151,The sensation of hunger was less after the egg breakfast ( p  = 0.028 for diet by time interaction) and returned more quickly after the cereal breakfast.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'B Keogh', 'Affiliation': 'UniSA Clinical and Health Sciences, University of South Australia, Adelaide SA 5000, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'M Clifton', 'Affiliation': 'UniSA Clinical and Health Sciences, University of South Australia, Adelaide SA 5000, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17155583']
1563,32756479,Effects of Ramadan Intermittent Fasting on Gut Hormones and Body Composition in Males with Obesity.,"We studied the effects of Ramadan intermittent fasting (RIF) on gut hormones (leptin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), and ghrelin) in males with obesity. Thirty sedentary males were randomly allocated to either an experimental group (EG,  n  = 15) or a control group (CG,  n  = 15). The EG group completed their Ramadan fasting rituals (30 days), whereas the CG continued with their normal daily habits. Blood samples were collected at four time points: 24 h before the start of Ramadan (T0), on the 15th day of Ramadan (T1), the day after the end of Ramadan (T2) and 21 days after Ramadan (T3). There were significant pre-to-post improvements for leptin ( p  = 0.01,  d  = 1.52), GLP-1 ( p  = 0.022,  d  = 0.75), PYY ( p  = 0.031,  d  = 0.69) and CCK ( p  = 0.027,  d  = 0.81) in the EG, with no interaction effect for ghrelin ( p  = 0.74;  d  = 0.008). No significant changes ( p  > 0.05) occurred in plasma volume variations (ΔPV) after RIF in both EG (-0.03 ± 0.01%) and CG (0.06 ± 0.07%). RIF represents an effective strategy to modify appetite-regulating hormones, leading to improved body composition indices and reduced obesity.",2020,"There were significant pre-to-post improvements for leptin ( p  = 0.01,  d  = 1.52), GLP-1 ( p  = 0.022,  d  = 0.75), PYY ( p  = 0.031,  d  = 0.69) and CCK ( p  = 0.027,  d  = 0.81) in the EG, with no interaction effect for ghrelin ( p  = 0.74;  d  = 0.008).","['Males with Obesity', 'Thirty sedentary males', 'males with obesity']","['Ramadan Intermittent Fasting', 'Ramadan intermittent fasting (RIF']","['plasma volume variations (ΔPV', 'Gut Hormones and Body Composition', 'leptin', 'Blood samples', 'GLP-1', 'GLP-1), peptide YY (PYY), cholecystokinin (CCK), and ghrelin', 'gut hormones (leptin, glucagon-like peptide-1']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}]",30.0,0.0168911,"There were significant pre-to-post improvements for leptin ( p  = 0.01,  d  = 1.52), GLP-1 ( p  = 0.022,  d  = 0.75), PYY ( p  = 0.031,  d  = 0.69) and CCK ( p  = 0.027,  d  = 0.81) in the EG, with no interaction effect for ghrelin ( p  = 0.74;  d  = 0.008).","[{'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Zouhal', 'Affiliation': 'Laboratoire Mouvement, Sport, Santé (M2S)-EA 1274, Université Rennes, F-35000 Rennes, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan 8174673441, Iran.'}, {'ForeName': 'Raoua', 'Initials': 'R', 'LastName': 'Triki', 'Affiliation': 'ISSEP Ksar Said, University of La Manouba, Tunis 2000, Tunisia.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Saeidi', 'Affiliation': 'Department of Physical Education, Damghan Branch, Islamic Azad University, Damghan 3671637849, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Laher', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, BC V6T 1Z4, Canada.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa 359-1192, Japan.'}, {'ForeName': 'Abderraouf', 'Initials': 'A', 'LastName': 'Ben Abderrahman', 'Affiliation': 'ISSEP Ksar Said, University of La Manouba, Tunis 2000, Tunisia.'}]",International journal of environmental research and public health,['10.3390/ijerph17155600']
1564,32756485,Schoolteachers' Knowledge of Attention-Deficit/Hyperactivity Disorder-Current Status and Effectiveness of Knowledge Improvement Program: A Randomized Controlled Trial.,"BACKGROUND


Adequately knowledgeable schoolteachers can play an essential role in early detection and proper treatment of children with attention-deficit/hyperactivity disorder (ADHD) at school.
OBJECTIVES


To assess the schoolteachers' knowledge of ADHD and to evaluate the effectiveness of the ADHD knowledge improvement program.
METHODS


A randomized controlled trial study design was followed on 100 primary school teachers from Abha City, Saudi Arabia. Teachers were randomly selected and allocated into trial and control groups. A self-administered questionnaire was used to evaluate teachers' knowledge about ADHD. After the baseline assessment, participants in the trial group received a two-day ADHD knowledge improvement program. Teachers' knowledge about ADHD was reassessed using the same questionnaire immediately after finishing the intervention program and after three months in both groups.
RESULTS


Only 16% and 22% of trial and control groups, respectively, showed adequate baseline knowledge about ADHD. Teachers' main sources of information about ADHD were the internet (67%), friends (47%), TV (34%), and reading books (23%). Knowledge of teachers in the trial group significantly improved immediately after the intervention. After three months, these knowledge benefits slightly declined but remained more adequate than those of teachers in the control group. The logistic regression model revealed that being a participant in the trial group and of higher qualification were associated with significant improvement in teachers' retained knowledge on ADHD ( p  < 0.001 and  p  = 0.050, respectively).
CONCLUSIONS


The majority of male primary school teachers in Abha City, Saudi Arabia, have inadequate knowledge about ADHD. Applying a knowledge improvement program can substantially improve their knowledge of ADHD. Consideration should be given to the integration of ADHD knowledge improvement program into teachers' educational programs.",2020,"Teachers' main sources of information about ADHD were the internet (67%), friends (47%), TV (34%), and reading books (23%).","['male primary school teachers in Abha City, Saudi Arabia', '100 primary school teachers from Abha City, Saudi Arabia', 'children with attention-deficit/hyperactivity disorder (ADHD) at school']",['Knowledge Improvement Program'],"[""teachers' retained knowledge on ADHD""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",100.0,0.0228989,"Teachers' main sources of information about ADHD were the internet (67%), friends (47%), TV (34%), and reading books (23%).","[{'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Alshehri', 'Affiliation': 'Joint Program of Saudi Board in Community Medicine, Southern Region 61421, Saudi Arabia.'}, {'ForeName': 'Shehata F', 'Initials': 'SF', 'LastName': 'Shehata', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, King Khalid University, Abha 61421, Saudi Arabia.'}, {'ForeName': 'Khalid M', 'Initials': 'KM', 'LastName': 'Almosa', 'Affiliation': 'Community Medicine Consultant, Joint Program of Saudi Board in Community Medicine, Southern Region 61421, Saudi Arabia.'}, {'ForeName': 'Nabil J', 'Initials': 'NJ', 'LastName': 'Awadalla', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, King Khalid University, Abha 61421, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph17155605']
1565,32756488,Antidepressant Effect of Shaded White Leaf Tea Containing High Levels of Caffeine and Amino Acids.,"The young leaves of green tea become lighter in color than usual when protected from sunlight by a shading net for about two weeks while growing. These leaves are called ""shaded white leaf tea"" or SWLT. In the eluate of SWLT, the amount of amino acids (361 mg/L) was significantly higher than that in regular tea (53.5 mg/L). Since theanine and arginine, the first and second most abundant amino acids in SWLT, have significant antistress effects, we examined the antistress effect of SWLT on humans. SWLT or placebo green tea (3 g) was eluted with room-temperature water (500 mL). Participants consumed the tea for one week prior to pharmacy practice and continued for 10 days in the practice period. The state-trait anxiety inventory, an anxiety questionnaire, tended to be scored lower in the SWLT group than the placebo, but other stress markers showed no differences. The effect of the difference in SWLT components examined with mice showed that aspartic acid and asparagine, which are abundant in SWLT, counteracted the antistress effects of theanine and arginine. Large amounts of caffeine also interfered with SWLT's antistress effect. Thus, SWLT, which is high in caffeine and amino acids, suppressed depressant behavior in mice.",2020,"In the eluate of SWLT, the amount of amino acids (361 mg/L) was significantly higher than that in regular tea (53.5 mg/L).",[],"['Caffeine and Amino Acids', 'caffeine', 'Shaded White Leaf Tea', 'SWLT or placebo green tea', 'amino acids', 'placebo']","['state-trait anxiety inventory, an anxiety questionnaire']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0461238,"In the eluate of SWLT, the amount of amino acids (361 mg/L) was significantly higher than that in regular tea (53.5 mg/L).","[{'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Unno', 'Affiliation': 'Tea Science Center, Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Furushima', 'Affiliation': 'Department of Drug Evaluation & Informatics, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Yuzuki', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Department of Drug Evaluation & Informatics, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Department of Drug Evaluation & Informatics, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Iguchi', 'Affiliation': 'Department of Neurophysiology, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Taguchi', 'Affiliation': 'Tea Science Center, Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Tea Research Center, Shizuoka Prefectural Research Institute of Agriculture and Forestry, Kikugawa, Shizuoka 439-0002, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ozeki', 'Affiliation': 'Nutrition Division, R&D Group, Taiyo Kagaku Co., Ltd., Yokkaichi, Mie 510-0844, Japan.'}, {'ForeName': 'Yoriyuki', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Tea Science Center, Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25153550']
1566,32757418,The efficacy of administrating a sweet-tasting solution for reducing the pain related to dental injections in children: A randomized controlled trial.,"BACKGROUND


Anaesthetic injections are an unpleasant experience for children in the dental office. Oral intake of sweet substances by newborns has been shown to be effective in reducing pain.
AIM


The purpose of this study was to determine whether a prior administration of a sweet-tasting solution has an effect on dental injection pain.
DESIGN


A total 60 healthy children needing bilateral maxillary primary canine extraction were included in this split-mouth randomized clinical trial. In the test side, dental injection (local infiltration) was applied after the patient received a sweet-tasting solution, while in the control side sterile water was administered. The patients' demographic characteristics, body mass index (BMI), and sweet taste preference were recorded. Pain perception during injection was measured using visual analogue scale (VAS) and sound, eye, body movement (SEM).
RESULTS


Mean VAS (28.30 ± 6.43) and SEM (2.14 ± 0.78) in the test side were lower than the control side (45.80 ± 7.17 and 2.95 ± 1.00). It was shown that higher BMI was associated with reduction in the analgesic effect, while the individual's tendency to sweetness increased pain reduction.
CONCLUSIONS


Sweet taste administration before dental injections in children helps to control the associated pain. This effect is influenced by the individual's sweet taste tendency and BMI.",2020,"It was shown that higher BMI was associated with reduction in the analgesic effect while the individual's tendency to sweetness increased pain reduction.
","['children in the dental office', '60 healthy children needing bilateral maxillary primary canine extraction', 'children']","['sweet tasting solution', 'sweet-tasting solution']","['pain reduction', 'Pain perception', 'visual analogue scale (VAS) and sound, eye, body movement (SEM', 'demographic characteristics, body mass index (BMI) and sweet taste preference', 'Mean VAS ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011386', 'cui_str': 'Dental Office'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.181686,"It was shown that higher BMI was associated with reduction in the analgesic effect while the individual's tendency to sweetness increased pain reduction.
","[{'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Shiraz University of Medical Science, Shiraz, Fars, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Ahmadbeigi', 'Affiliation': 'School of Dentistry, Shaherkord University of Medical Sciences, Shahrekord, Chaharmahal Bakhtiari, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Vossoughi', 'Affiliation': 'Oral and Dental Disease Research Center, Department of Dental Public Health, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Sardarian', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.'}]",International journal of paediatric dentistry,['10.1111/ipd.12697']
1567,32757427,Use of an audit with feedback implementation strategy to promote medication error reporting by nurses.,"AIMS AND OBJECTIVES


To outline the development and effect of an audit with feedback implementation strategy that intended to increase the rate of voluntary medication error reporting by nurses.
BACKGROUND


Medication errors are a serious global health issue. Audit with feedback is a widely used implementation strategy that has potential to modify nurses' reporting behaviour and improve medication error reporting rates.
DESIGN


Quasi-experimental implementation study (fulfilling the TIDieR checklist) with two pairs of matched wards at a private hospital in Australia was conducted from March 2015-September 2016. One ward from each pair was randomised to either the intervention or control group.
METHOD


Nurses within intervention wards received audit with feedback on a quarterly basis over a 12-month implementation period. Control wards underwent quarterly audits only (without feedback). Feedback consisted of a one-page infographic poster, with content based on medication error data obtained from audits and the hospitals' risk management system (RiskMan). The primary outcome-rate of medication errors reported per month-was determined in both groups at pre-implementation, implementation and postimplementation phases. Differences between groups were compared using generalised linear mixed models with Poisson distribution and log link.
RESULTS


A nonsignificant intervention effect was found for rate of medication errors reported per month. Interestingly, when combining data from both groups, a significant increasing time trend was observed for medication errors reported per month across pre-implementation and implementation phases (80% increase).
CONCLUSIONS


The audit with feedback strategy developed in the present study did not effectively influence the voluntary reporting of medication errors by nurses.
RELEVANCE TO CLINICAL PRACTICE


Despite the lack of intervention effects, the use of a published checklist to optimise the reporting quality of this study will contribute to the field by furthering the understanding of how to enhance audit with feedback implementation strategies for nurses.",2020,"Audit with feedback is a widely-used implementation strategy that has potential to modify nurses' reporting behaviour and improve medication error reporting rates.
","['Nurses within intervention wards received audit with feedback on a quarterly basis over a 12-month implementation period', 'Quasi-experimental implementation study (fulfilling the TIDieR checklist) with two pairs of matched wards at a private hospital in Australia was conducted from March 2015-September 2016']",[],"['rate of medication errors', ' rate of medication errors reported per month ']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]",[],"[{'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0347824,"Audit with feedback is a widely-used implementation strategy that has potential to modify nurses' reporting behaviour and improve medication error reporting rates.
","[{'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Hutchinson', 'Affiliation': 'School of Nursing & Midwifery, Centre for Quality & Patient Safety Research, Institute for Health Transformation, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Brotto', 'Affiliation': 'School of Nursing & Midwifery, Centre for Quality & Patient Safety Research, Institute for Health Transformation, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chapman', 'Affiliation': 'School of Nursing & Midwifery, Centre for Quality & Patient Safety Research, Institute for Health Transformation, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Sales', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Tracey K', 'Initials': 'TK', 'LastName': 'Bucknall', 'Affiliation': 'School of Nursing & Midwifery, Centre for Quality & Patient Safety Research, Institute for Health Transformation, Faculty of Health, Deakin University, Geelong, VIC, Australia.'}]",Journal of clinical nursing,['10.1111/jocn.15447']
1568,32693009,Physical exercise interventions have no effect on serum BDNF concentration in older adults living in long-term nursing homes.,"Physical exercise protects against age-related cognitive decline. Brain-derived neurotrophic factor (BDNF) may mediate some of the cognitive benefits of physical exercise, but the effect of physical exercise on serum BDNF is unclear. Indeed, differential findings have been reported depending on the characteristics of the participants and the intensity, duration, and type of exercise. The aim of this study was to determine whether three different physical exercise interventions alter serum BDNF levels in older adults living in long-term nursing homes (LTNHs) and whether changes in physical, cognitive, and dual-task performance are related to changes in serum BDNF. LTNH study participants (n = 126) were randomly assigned to multicomponent or dual-task training or a walking program and serum BDNF levels were analyzed by ELISA. We also assessed physical, cognitive, and dual-task parameters. Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs. Changes in BDNF during the interventions were not significantly associated with modifications in physical, cognitive or dual-task performance parameters. Our results provide new evidence clarifying the relationship between physical and cognitive exercise and BDNF.",2020,"Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs.","['older adults living in long-term nursing homes (LTNHs', 'older adults living in LTNHs', 'LTNH study participants (n\u202f=\u202f126', 'older adults living in long-term nursing homes']","['physical exercise interventions', 'multicomponent or dual-task training or a walking program and serum BDNF levels were analyzed by ELISA', 'Physical exercise', 'multicomponent, dual-task, nor walking exercise programs', 'Physical exercise interventions']","['physical, cognitive, and dual-task parameters', 'physical, cognitive or dual-task performance parameters', 'serum BDNF levels', 'serum BDNF concentration']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",126.0,0.0209679,"Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: chloe.rezola@ehu.eus.'}, {'ForeName': 'Gotzone', 'Initials': 'G', 'LastName': 'Hervás', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: gotzone.hervas@ehu.eus.'}, {'ForeName': 'Haritz', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursery, University of the Basque Country (UPV/EHU), Paseo Dr. J. Beguiristain, 105, Donostia/San Sebastian 20014, Gipuzkoa, Spain; Onkologikoa Foundation, Paseo Doctor Beguiristain, 121, Donostia/San Sebastián 20014, Gipuzkoa, Spain. Electronic address: haritz.arrieta@ehu.eus.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Hernández-de Diego', 'Affiliation': 'Zorroaga Foundation, Alto Zorroaga, 1, Donostia/San Sebastian 20014, Gipuzkoa, Spain. Electronic address: s.hernandez@zorroaga.eus.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ruiz-Litago', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: fatima.ruiz@ehu.eus.'}, {'ForeName': 'Susana Maria', 'Initials': 'SM', 'LastName': 'Gil', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: susana.gil@ehu.eus.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: ana.rodriguez@ehu.eus.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: jon.irazusta@ehu.eus.'}]",Experimental gerontology,['10.1016/j.exger.2020.111024']
1569,32698326,Psychometric and Structural Validity of the Pittsburgh Sleep Quality Index among Filipino Domestic Workers.,"Objectives : Evaluate the psychometric properties and structural validity of the Filipino version of the Pittsburgh Sleep Quality Index (PSQI) among Filipino domestic workers (FDWs).  Methods : In Study 1, 131 FDWs completed PSQI and other scales, along with 10-day actigraphic assessment with accompanying electronic daily sleep dairy. A subsample of 61 participants completed follow-up assessment after 10 days. In Study 2, 1363 FDWs were recruited and randomized into two halves. Exploratory factor analysis (EFA) and Confirmatory factor analysis (CFA) were used in the two halves, respectively.  Results : In Study 1, the Cronbach's alpha of the PSQI was 0.63 at baseline and 0.67 at follow-up. Test-retest reliability for the PSQI global score based on intraclass correlation was 0.63. Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination. Small correlations between the PSQI global score and measures of daytime sleepiness, social support, and self-reported height, supported discriminant validity. In Study 2, EFA yielded two PSQI factors with acceptable factor loadings. CFA established that this two-factor model, comprised of perceived sleep quality and sleep efficiency, evidenced better model fit than alternative models tested. The Cronbach's alpha of two factors was 0.70 and 0.81, respectively.  Conclusions : The PSQI demonstrated good internal consistency of two factors, and good convergent, and divergent validity. Results can be referenced in future studies to measure and screen sleep dysfunction among clinical and non-clinical populations in the Philippines.",2020,"Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination.","['1363 FDWs', 'Filipino domestic workers (FDWs', 'Filipino Domestic Workers']",['Filipino version of the Pittsburgh Sleep Quality Index (PSQI'],"['Exploratory factor analysis (EFA) and Confirmatory factor analysis (CFA', 'sleep quality and sleep efficiency', 'PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination', 'PSQI global score and measures of daytime sleepiness, social support, and self-reported height', 'Psychometric and Structural Validity of the Pittsburgh Sleep Quality Index']","[{'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",1363.0,0.0399617,"Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiong', 'Affiliation': 'Division of Medical Psychology and Behavioral Sciences, Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Johns Hopkins Center on Aging and Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hall', 'Affiliation': 'Global and Community Mental Health Research Group, Department of Psychology, The University of Macau, Macau (SAR) 999078, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17145219']
1570,32698410,"Treatment of Patients with Advanced Biliary Tract Cancer with Either Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine-A Randomized Phase II Trial.","This study is an investigator-initiated randomized phase II trial focusing on the treatment of advanced biliary tract cancer with either oxaliplatin 50 mg/m 2  and gemcitabine 1000 mg/m 2  on day 1 in a two-week cycle with capecitabine 650 mg/m 2  twice-daily continuously or cisplatin 25 mg/m 2  and gemcitabine 1000 mg/m 2  on day 1 and day 8 in a three-week cycle. One-hundred patients were included. Forty-seven patients received oxaliplatin, gemcitabine, and capecitabine with a median progression-free survival (mPFS) of 5.7 months (95% CI 3.0-7.8) and a median overall survival (mOS) of 8.7 months (95% CI 6.5-11.2). Forty-nine patients received cisplatin and gemcitabine with a mPFS of 7.3 months (95% CI 6.0-8.7) and a mOS of 12.0 months (95% CI 8.3-16.7). This trial confirms a mOS of 12 months with cisplatin and gemcitabine, as found in earlier trials. With a superior tumor control rate of 79% vs. 60% ( p  = 0.045), a difference in the mPFS of 1.6 months (HR = 0.721,  p  = 0.1), and a difference in the mOS of 3.3 months (HR = 0.731,  p  = 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.",2020,"With a superior tumor control rate of 79% vs. 60% ( p  = 0.045), a difference in the mPFS of 1.6 months (HR = 0.721,  p  = 0.1), and a difference in the mOS of 3.3 months (HR = 0.731,  p  = 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.","['One-hundred patients were included', 'Patients with Advanced Biliary Tract Cancer with Either', 'advanced biliary tract cancer', 'advanced biliary tract cancer with either']","['Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine', 'oxaliplatin 50 mg/m 2  and gemcitabine', 'capecitabine 650 mg/m 2  twice-daily continuously or cisplatin 25 mg/m 2  and gemcitabine', 'oxaliplatin, gemcitabine, and capecitabine', 'cisplatin and gemcitabine']",['median overall survival'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4081032', 'cui_str': 'oxaliplatin 50 MG'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",100.0,0.0374273,"With a superior tumor control rate of 79% vs. 60% ( p  = 0.045), a difference in the mPFS of 1.6 months (HR = 0.721,  p  = 0.1), and a difference in the mOS of 3.3 months (HR = 0.731,  p  = 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Markussen', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, 2730 Herlev, Denmark.'}, {'ForeName': 'Lars Henrik', 'Initials': 'LH', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, Vejle University Hospital, 7100 Vejle, Denmark.'}, {'ForeName': 'Laura Vittrup', 'Initials': 'LV', 'LastName': 'Diness', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, 2730 Herlev, Denmark.'}, {'ForeName': 'Finn Ole', 'Initials': 'FO', 'LastName': 'Larsen', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, 2730 Herlev, Denmark.'}]",Cancers,['10.3390/cancers12071975']
1571,32697879,"Bi-hemispheric transcranial direct current stimulation for upper-limb hemiparesis in acute stroke: a randomized, double-blind, sham-controlled trial.","BACKGROUND AND PURPOSE


Neuromodulation is a promising approach to increasing motor recovery in stroke; however, to date, there is a scarcity of evidence documenting the clinical potential of transcranial direct current stimulation (tDCS) administered in the acute phase of stroke. The present study aims to examine the clinical effects of a treatment involving the application of tDCS in the acute stage post-stroke.
METHODS


This was a randomized, double-blind, sham-controlled trial. A cohort of 32 stroke patients with severe motor impairment underwent 5 days of treatment with real or sham bi-hemispheric tDCS over the motor cortex. During the treatment, tDCS was applied twice per day (two daily applications each of 15 min), starting 48 to 72 h after stroke onset.
RESULTS


We found statistically significant improvements after both real and sham tDCS treatments in primary (hand grip strength, Motricity Index) and secondary (National Institutes of Health Stroke Scale score, Barthel Index) outcomes. Patients receiving real tDCS showed a larger improvement of upper-limb muscle strength at the end of treatment phase; this advantage was no longer present after 6 months.
CONCLUSIONS


Transcranial direct current stimulation may be used to accelerate the rate of upper-limb motor recovery during the spontaneous recovery period.",2020,"We found statistically significant improvements after both real and sham tDCS treatments in primary (Hand Grip Strength, Motricity Index) and secondary (NIHSS, Barthel Index) outcomes.","['acute stroke', '32 stroke patients with severe motor impairment underwent a']","['real tDCS', 'tDCS', 'Bihemispheric tDCS', '5-days treatment with real or sham bi-hemispheric tDCS']","['upper-limb muscle strength', 'rate of upper-limb motor recovery', 'primary (Hand Grip Strength, Motricity Index) and secondary (NIHSS, Barthel Index) outcomes']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0451322', 'cui_str': 'Motricity index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.629061,"We found statistically significant improvements after both real and sham tDCS treatments in primary (Hand Grip Strength, Motricity Index) and secondary (NIHSS, Barthel Index) outcomes.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bolognini', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Russo', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Souza Carneiro', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nicotra', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Olgiati', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Spandri', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Agostoni', 'Affiliation': ""Neurology and Stroke Unit, Department of Neurosciences, Niguarda Ca' Granda Hospital, Milan, Italy.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salmaggi', 'Affiliation': 'Neurology - Stroke Unit, A. Manzoni Hospital, ASST Lecco, Lecco, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vallar', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}]",European journal of neurology,['10.1111/ene.14451']
1572,32702468,Predicting post one-year durability of glucose-lowering monotherapies in patients with newly-diagnosed type 2 diabetes mellitus - A MASTERMIND precision medicine approach (UKPDS 87).,"AIMS


Predicting likely durability of glucose-lowering therapies for people with type 2 diabetes (T2D) could help inform individualised therapeutic choices.
METHODS


We used data from UKPDS patients with newly-diagnosed T2D randomised to first-line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin. In 2339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥ 7.5% or requiring second-line therapy). Model validation was performed using bootstrap sampling.
RESULTS


Follow-up was median (IQR) 11.0 (8.0-14.0) years. Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years. Time-to-monotherapy-failure was predicted primarily by HbA 1c  and BMI values-with other risk factors varying by type of monotherapy-with predictions to within ±2.5 years for 55%-60%-56% and 57% of the chlorpropamide-glibenclamide-basal insulin and metformin monotherapy cohorts respectively.
CONCLUSIONS


Post one-year glycaemic durability can be predicted robustly in individuals with newly-diagnosed T2D who achieve HbA 1c values  < 7.5% one year after commencing traditional monotherapies. Such information could be used to help guide glycaemic management for individual patients.",2020,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"['2,339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥7.5% or requiring second-line therapy', 'people with type 2 diabetes ', 'Patients with Newly-diagnosed Type 2 Diabetes Mellitus', 'UKPDS patients with newly-diagnosed T2D randomised to first']","['chlorpropamide-glibenclamide-basal insulin or metformin', 'line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin', 'glucose-lowering therapies', 'Glucose-lowering Monotherapies']","['Monotherapy-failure', 'Time-to-monotherapy-failure']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0008287', 'cui_str': 'Chlorpropamide'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2339.0,0.0533422,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"[{'ForeName': 'Olorunsola F', 'Initials': 'OF', 'LastName': 'Agbaje', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK. Electronic address: olorunsola.agbaje@dtu.ox.ac.uk.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Jones', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Medical Research Institute, University of Dundee, Dundee, UK.'}, {'ForeName': 'Beverley M', 'Initials': 'BM', 'LastName': 'Shields', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108333']
1573,32708859,Exploring the Effect of Esomeprazole on Gastric and Duodenal Fluid Volumes and Absorption of Ritonavir.,"Proton-pump inhibitors (PPIs), frequently prescribed to lower gastric acid secretion, often exert an effect on the absorption of co-medicated drug products. A previous study showed decreased plasma levels of the lipophilic drug ritonavir after co-administration with the PPI Nexium (40 mg esomeprazole), even though duodenal concentrations were not affected. The present study explored if a PPI-induced decrease in gastrointestinal (GI) fluid volume might contribute to the reduced absorption of ritonavir. In an exploratory cross-over study, five volunteers were given a Norvir tablet (100 mg ritonavir) orally, once without PPI pre-treatment and once after a three-day pre-treatment with the PPI esomeprazole. Blood samples were collected for eight hours to assess ritonavir absorption and magnetic resonance imaging (MRI) was used to determine the gastric and duodenal fluid volumes during the first three hours after administration of the tablet. The results confirmed that PPI intake reduced ritonavir plasma concentrations by 40%. The gastric residual volume and gastric fluid volume decreased by 41% and 44% respectively, while the duodenal fluid volume was reduced by 33%. These data suggest that the PPI esomeprazole lowers the available fluid volume for dissolution, which may limit the amount of ritonavir that can be absorbed. Although additional factors may play a role, the effect of PPI intake on the GI fluid volume should be considered when simulating the absorption of poorly soluble drugs like ritonavir in real-life conditions.",2020,"The gastric residual volume and gastric fluid volume decreased by 41% and 44% respectively, while the duodenal fluid volume was reduced by 33%.",[],"['Norvir tablet (100 mg ritonavir', 'PPI esomeprazole', 'esomeprazole', 'Proton-pump inhibitors (PPIs', 'Esomeprazole', 'ritonavir absorption and magnetic resonance imaging (MRI']","['duodenal concentrations', 'Gastric and Duodenal Fluid Volumes and Absorption of Ritonavir', 'duodenal fluid volume', 'plasma levels', 'gastric residual volume and gastric fluid volume', 'ritonavir plasma concentrations']",[],"[{'cui': 'C0678152', 'cui_str': 'Norvir'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0227306', 'cui_str': 'Duodenal juice'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}]",5.0,0.0522133,"The gastric residual volume and gastric fluid volume decreased by 41% and 44% respectively, while the duodenal fluid volume was reduced by 33%.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'de Waal', 'Affiliation': 'Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Herestraat 49-Box 921, 3000 Leuven, Belgium.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Rubbens', 'Affiliation': 'Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Herestraat 49-Box 921, 3000 Leuven, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grimm', 'Affiliation': 'Center of Drug Absorption and Transport, Institute of Pharmacy, University of Greifswald, 17489 Greifswald, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vandecaveye', 'Affiliation': 'Radiology Department, University Hospitals Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, TARGID, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Weitschies', 'Affiliation': 'Center of Drug Absorption and Transport, Institute of Pharmacy, University of Greifswald, 17489 Greifswald, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Brouwers', 'Affiliation': 'Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Herestraat 49-Box 921, 3000 Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Augustijns', 'Affiliation': 'Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Herestraat 49-Box 921, 3000 Leuven, Belgium.'}]",Pharmaceutics,['10.3390/pharmaceutics12070670']
1574,32710219,Correction to: Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.",2020,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.",['vertical bone augmentation'],[],[],"[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],[],,0.0260633,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Moest', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany. tobias.moest@uk-erlangen.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Frabschka', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Marco Rainer', 'Initials': 'MR', 'LastName': 'Kesting', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Christian Martin', 'Initials': 'CM', 'LastName': 'Schmitt', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Gesche', 'Initials': 'G', 'LastName': 'Frohwitter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Lutz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Karl Andreas', 'Initials': 'KA', 'LastName': 'Schlegel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03466-3']
1575,32706780,Transcranial direct current stimulation and working memory: Comparison of effect on learning shapes and English letters.,"We present the results of a study investigating whether there is an effect of Anodal-Transcranial Direct Current Stimulation (A-tDCS) on working memory (WM) performance. The relative effectiveness of A-tDCS on WM is investigated using a 2-back test protocol using two commonly used memory visual stimuli (shapes and letters). In a double-blinded, randomised, crossover, sham-controlled experiment, real A-tDCS and sham A-tDCS were applied separately to the left dorsolateral prefrontal cortex (L-DLPFC) of twenty healthy subjects. There was a minimal interval of one week between sham and real A-tDCS sessions. For the letters based stimulus experiment, 2-back test recall accuracy was measured for a set of English letters (A-L) which were presented individually in a randomised order where each was separated by a blank interval. A similar 2-back protocol was used for the shapes based stimuli experiment where instead of letters, a set of 12 geometric shapes were used. The working memory accuracy scores measured appeared to be significantly affected by memory stimulus type used and by the application of A-tDCS (repeated measures ANOVA p<0.05). A large effect size (d = 0.98) and statistical significance between sham and real A-tDCS WM scores (p = 0.01) was found when shapes were used as a visual testing stimulus, while low (d = 0.38) effect size and insignificant difference (p = 0.15) was found when letters were used. This results are important as they show that recollection different stimuli used in working memory can be affected differently by A-tDCS application. This highlights the importance of considering using multiple methods of WM testing when assessing the effectiveness of A-tDCS.",2020,"A large effect size (d = 0.98) and statistical significance between sham and real A-tDCS WM scores (p = 0.01) was found when shapes were used as a visual testing stimulus, while low (d = 0.38) effect size and insignificant difference (p = 0.15) was found when letters were used.",['twenty healthy subjects'],"['Transcranial direct current stimulation and working memory', 'Anodal-Transcranial Direct Current Stimulation (A-tDCS', 'tDCS and sham A-tDCS']","['working memory (WM) performance', 'working memory accuracy scores']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0482749,"A large effect size (d = 0.98) and statistical significance between sham and real A-tDCS WM scores (p = 0.01) was found when shapes were used as a visual testing stimulus, while low (d = 0.38) effect size and insignificant difference (p = 0.15) was found when letters were used.","[{'ForeName': 'Sriharsha', 'Initials': 'S', 'LastName': 'Ramaraju', 'Affiliation': 'Interdisciplinary Computing and Complex Bio Systems (ICOS) Faculty of Computing, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Roula', 'Affiliation': 'Medical Electronics and Signal Processing Research Unit, University of South Wales, Treforest, United Kingdom.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'McCarthy', 'Affiliation': 'Clinical Technology and Diagnostics Research Unit, University of South Wales, Treforest, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0222688']
1576,32707593,"Effects of Child-Pugh B Cirrhosis on Pharmacokinetics of Tofogliflozin, a New Sodium-Glucose Co-Transporter (SGLT2) Inhibitor.","BACKGROUND


Tofogliflozin is a highly selective sodium-glucose co-transporter 2 (SGLT2) inhibitor. A mass balance study with combinations of microdoses revealed that tofogliflozin has high oral bioavailability (97.5%) and that tofogliflozin in circulation is eliminated primarily by metabolic pathways, with the liver playing a prominent role in elimination.
OBJECTIVES


This study aimed to evaluate the effect of moderate hepatic impairment on the pharmacokinetics of tofogliflozin and on the pharmacodynamics (urinary glucose excretion [UGE]).
METHODS


In an open-label, parallel-group study, 17 subjects (9 with moderate hepatic impairment [Child-Pugh Class B, score 7-9] and 8 healthy) received a single oral dose of 40 mg tofogliflozin. Plasma and urine concentrations of tofogliflozin were determined. Accumulated UGE, adverse events, and physiological and laboratory test data were monitored.
RESULTS


Geometric mean ratio (GMR; geometric mean value for subjects with moderate hepatic impairment / geometric mean value for healthy subjects) of C max  was 1.47 and GMR of AUC inf  was 1.70. Moderate hepatic impairment had only a little effect on t max  and CL R  but it prolonged MRT. The levels of cumulative UGE were similar between the 2 groups. No clinically significant adverse events, laboratory test values, or physiological test values were observed in any subject.
CONCLUSIONS


Moderate hepatic impairment increased C max  and AUC inf  of tofogliflozin by 47% and 70%, respectively. This increase in tofogliflozin exposure did not increase UGE in hepatically impaired subjects. A single oral dose of 40 mg tofogliflozin was well tolerated, supporting dose adjustment is unnecessary even in moderately hepatically impaired subjects.",2020,"No clinically significant adverse events, laboratory test values, or physiological test values were observed in any subject.
","['17 subjects (9 with moderate hepatic impairment [Child-Pugh Class B, score 7-9] and 8 healthy']","['tofogliflozin', 'Tofogliflozin', 'single oral dose of 40 mg tofogliflozin', 'Tofogliflozin, a New Sodium-Glucose Co-Transporter (SGLT2) Inhibitor']","['adverse events, laboratory test values, or physiological test values', 'C max  and AUC inf  of tofogliflozin', 'Moderate hepatic impairment', 'oral bioavailability', 'levels of cumulative UGE', 'Geometric mean ratio (GMR; geometric mean value', 'tofogliflozin exposure', 'Plasma and urine concentrations of tofogliflozin', 'Accumulated UGE, adverse events, and physiological and laboratory test data']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",17.0,0.0295616,"No clinically significant adverse events, laboratory test values, or physiological test values were observed in any subject.
","[{'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Social Insurance Chuo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Ohira', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Ikegami', 'Affiliation': 'Clinical Research Hospital Tokyo, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Clinical Research Hospital Tokyo, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Kazumichi', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Inano', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Sumire', 'Initials': 'S', 'LastName': 'Shimada', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ohba', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kimio', 'Initials': 'K', 'LastName': 'Terao', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Ohnishi', 'Affiliation': 'The Jikei University School of Medicine, Tokyo, Japan.'}]",Drug research,['10.1055/a-1202-0818']
1577,32711121,A Population-Based Mortality Follow-Back Survey Evaluating Good Death for Cancer and Noncancer Patients: A Randomized Feasibility Study.,"CONTEXT


Evaluation of end-of-life care is a key element in quality improvement, and population-based mortality follow-back designs have been used in several countries. This design was adapted to evaluate a good death in Japan.
OBJECTIVES


This study aimed to explain the scientific background and rationale for assessing the feasibility of a mortality follow-back survey using a randomized design.
DESIGN


We used a cross-sectional questionnaire survey to assess feasibility using response rate, sample representativeness, effect on response rate with two methods, and survey acceptability.
SETTING/PARTICIPANTS


The subjects were 4812 bereaved family members of patients who died from the major five causes of death: cancer, heart disease, cerebrovascular disease, pneumonia, or kidney failure, using mortality data.
RESULTS


Overall, 682 (14.2%) questionnaires could not be delivered, and 2294 (55.5%) family members agreed to participate in the survey. There was little difference in the distribution of characteristics between the study subjects and the full population, and sample representativeness was acceptable. Sending the questionnaire with a pen achieved a higher response rate than without (weighted: 48.2% vs. 40.8%; P < 0.001). In follow-up contact, there was no difference in response rate between resending the questionnaire and a reminder letter alone (weighted: 32.9% vs. 32.4%; P = 0.803). In total, 84.8% (weighted) of the participants agreed with improving quality of care through this kind of survey.
CONCLUSION


This study demonstrated the feasibility of conducting a population-based mortality follow-back survey using a randomized design. An attached pen with the questionnaire was effective in improving the response rate.",2020,"In follow-up contact, there was no difference in response rate between resending the questionnaire and a reminder letter alone (weighted: 32.9% vs. 32.4%; p=0.803).","['Cancer and Non-cancer Patients', 'subjects were 4,812 bereaved family members of patients who died from the major five causes of death: cancer, heart disease, cerebrovascular disease, pneumonia, or kidney failure, using mortality data']",[],['response rate'],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",[],[],4812.0,0.0916359,"In follow-up contact, there was no difference in response rate between resending the questionnaire and a reminder letter alone (weighted: 32.9% vs. 32.4%; p=0.803).","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Nakazawa', 'Affiliation': 'Division of Medical Support and Partnership, Center for Cancer Control and Information Services, National Cancer Center, Chuo-ku, Tokyo, Japan. Electronic address: ynakazaw@ncc.go.jp.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Medical Support and Partnership, Center for Cancer Control and Information Services, National Cancer Center, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Department of Palliative Nursing, Health Sciences, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Nursing, Nagoya University Graduate School of Medicine, Nagoya Higashi-ku, Aichi, Japan.'}, {'ForeName': 'Asao', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Division of Psycho-Oncology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Palliative Care, Tokatu Hospital, Nagareyama, Chiba, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kizawa', 'Affiliation': 'Division of Palliative Medicine, Kobe University Hospital, Kobe University School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Department of Palliative and Supportive Care, Palliative Care Team, and Seirei Hospice, Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Division of Medical Support and Partnership, Center for Cancer Control and Information Services, National Cancer Center, Chuo-ku, Tokyo, Japan.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.013']
1578,32715653,"A pharmacist-managed dosing algorithm for darbepoetin alfa and iron sucrose in hemodialysis patients: A randomized, controlled trial.","The attainment of target hemoglobin levels in hemodialysis patients is low. Several factors play a role, such as hyporesponsiveness to erythropoiesis-stimulating agents (ESA), but also suboptimal prescribing of ESA and iron. The goal of this study was to investigate if a pharmacist-managed dosing algorithm for darbepoetin alfa (DA) and iron sucrose improves the attainment of target hemoglobin levels. In this randomized controlled trial, 200 hemodialysis patients from a Dutch teaching hospital were included. In the intervention group (n = 100), a pharmacist monthly provided dose recommendations for DA and iron sucrose based on dosing algorithms. The control group (n = 100) received usual care. In the intervention group, the percentage per patient within the target range (PTR) for hemoglobin (target range 6.8-7.4 mmol/L) and iron status was higher than in the control group (for hemoglobin median 38.5% vs 23.1%, P = .001 and for iron status median 21.1% vs 8.3%, P = .003). The percentage of high hemoglobin levels (>8.1 mmol/L) was lower in the intervention group (median 0.0% vs 7.7%, P = .034). The weekly dose of DA was lower in the intervention group (median 34.0 vs 46.9 mcg, P = .020), whereas iron dose was higher (median 75 vs 0 mg). No difference was found for the percentage of hemoglobin levels below the target range. In conclusion, a pharmacist-managed dosing algorithm for DA and iron sucrose increased the attainment of target levels for hemoglobin and iron status, reduced the percentage of high hemoglobin levels, and was associated with a lower DA and a higher iron sucrose dose.",2020,"The percentage of high hemoglobin levels (>8.1 mmol/L) was lower in the intervention group (median 0.0% vs 7.7%, P = .034).","['200 hemodialysis patients from a Dutch teaching hospital were included', 'hemodialysis patients']","['pharmacist monthly provided dose recommendations for DA and iron sucrose based on dosing algorithms', 'usual care', 'darbepoetin alfa and iron sucrose', 'darbepoetin alfa (DA) and iron sucrose']","['attainment of target hemoglobin levels', 'iron status', 'hemoglobin levels', 'percentage per patient within the target range (PTR) for hemoglobin', 'percentage of high hemoglobin levels']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",200.0,0.0682988,"The percentage of high hemoglobin levels (>8.1 mmol/L) was lower in the intervention group (median 0.0% vs 7.7%, P = .034).","[{'ForeName': 'Francisca Johanna', 'Initials': 'FJ', 'LastName': 'van den Oever', 'Affiliation': 'Department of Clinical Pharmacy, Franciscus Gasthuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Carolien F M', 'Initials': 'CFM', 'LastName': 'Heetman-Meijer', 'Affiliation': 'Department of Clinical Pharmacy, Franciscus Gasthuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Birnie', 'Affiliation': 'Department of Genetics, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Erwin C', 'Initials': 'EC', 'LastName': 'Vasbinder', 'Affiliation': 'Department of Clinical Pharmacy, Franciscus Gasthuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Eleonora L', 'Initials': 'EL', 'LastName': 'Swart', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacy, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne C', 'Initials': 'YC', 'LastName': 'Schrama', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis, Rotterdam, the Netherlands.'}]",Pharmacology research & perspectives,['10.1002/prp2.628']
1579,32712307,A 24-month randomized controlled trial on the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with the ART approach.,"OBJECTIVE


To compare the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with atraumatic restorative treatment (ART) approach.
METHOD


Cavitated dentine caries lesions in preschool children were randomly allocated to two groups to be applied with either 38% silver diamine fluoride (SDF) solution or tonic water (control) ten weeks before being restored with the ART approach. Status of the restorations were assessed every six months by a blinded independent examiner. Multilevel logistic regression and multilevel survival analyses were conducted to assess the restoration success rates.
RESULTS


A total of 194 children (SDF group, 101; control group, 93) were included, with 260 and 249 ART restorations placed in the SDF and the control groups, respectively. At 24-month follow-up, 88 (87 %) and 84 (90 %) children remained in the SDF and the control groups, respectively. There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05). The success rate of ART restorations was associated with the class of restorations. Class I restorations had the highest success rate (∼50 %), followed by Class V (∼35 %), Class II (∼15 %) and Class III (<10 %). Besides, the mean time used to place an ART restoration in a SDF-treated caries lesion was shorter than that in untreated lesion (4.8 vs. 5.1 min, p = 0.006).
CONCLUSION


Prior SDF application does not significantly affect the success rate of ART restorations placed in primary teeth. Besides, it is faster to place ART restorations in caries lesions that have been previously treated with SDF.
CLINICAL SIGNIFICANCE


Prior application of silver diamine fluoride solution on cavitated dentine caries lesions in primary teeth can shorten the average time required to place an ART restoration while not jeopardizing the success rate of the restorations.",2020,There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05).,"['Cavitated dentine caries lesions in preschool children', 'primary teeth with atraumatic restorative treatment (ART) approach', '194 children (SDF group, 101; control group, 93) were included, with 260 and 249 ART restorations placed in the SDF and the control groups, respectively', 'cavitated dentine caries lesions in primary teeth', 'primary teeth with the ART approach']","['38% silver diamine fluoride (SDF) solution or tonic water (control) ten weeks before being restored with the ART approach', 'restoring untreated and SDF-treated dentine caries lesions', 'silver diamine fluoride solution']","['ART restoration success rates', 'highest success rate', 'success rates', 'mean time used to place an ART restoration in a SDF-treated caries lesion', 'success rate of ART restorations', 'success rate']","[{'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0452449', 'cui_str': 'Tonic water'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",194.0,0.0638187,There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05).,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Chu', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Linlu', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China. Electronic address: edward-lo@hku.hk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103435']
1580,32717696,Using unfolding case studies to develop critical thinking skills in baccalaureate nursing students: A pilot study.,"BACKGROUND


Research has consistently demonstrated that new graduate nurses do not possess sufficient critical thinking skills when they transition to clinical practice. Unfolding case studies encourage students to participate in a number of critical thinking skills including information-seeking, logical reasoning, and analyzing of clinical data.
OBJECTIVE


The aim of this study was to determine how the use of unfolding case studies as a learning modality affected baccalaureate students' critical thinking skills in their Adult Health Theory course. The researcher compared course examination scores earned by nursing students who were taught using traditional case studies to scores obtained by nursing students who completed unfolding case studies.
SETTING


The pilot study took place at a moderate-sized comprehensive university in Wisconsin.
DESIGN


A non-experimental correlational design using course examination scores data was employed to examine how the use of unfolding case studies as a learning modality affected baccalaureate students' critical thinking skills in their Adult Health Theory course.
PARTICIPANTS


A total of 160 students comprised the intervention group while an additional 142 students represented the control group in the study.
METHODS


An independent-samples t-test was performed to explore differences in mean scores between the intervention and control groups.
RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
CONCLUSIONS


Results of this study suggest that unfolding case studies more effectively develop students' critical thinking skills than do a more traditional, static case study.",2020,"RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
","['A total of 160 students comprised the intervention group while an additional 142 students represented the control group in the study', 'baccalaureate nursing students', 'The pilot study took place at a moderate-sized comprehensive university in Wisconsin']",[],"['mean scores', 'mean examination scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",160.0,0.0283034,"RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Englund', 'Affiliation': 'University of Wisconsin Oshkosh, College of Nursing, 800 Algoma Blvd, Oshkosh, WI, United States of America. Electronic address: englundh@uwosh.edu.'}]",Nurse education today,['10.1016/j.nedt.2020.104542']
1581,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1582,32719129,Randomized trial shows healthcare payment reform has equal-sized spillover effects on patients not targeted by reform.,"Changes in the way health insurers pay healthcare providers may not only directly affect the insurer's patients but may also affect patients covered by other insurers. We provide evidence of such spillovers in the context of a nationwide Medicare bundled payment reform that was implemented in some areas of the country but not in others, via random assignment. We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients. We discuss the implications of these findings for estimates of the impact of healthcare payment reforms and more generally for the design of healthcare policy.",2020,"We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients.",[],[],[],[],[],[],,0.0338305,"We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients.","[{'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Einav', 'Affiliation': 'Department of Economics, Stanford University, Stanford, CA 94305.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA 02138; afink@mit.edu.'}, {'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Graduate School of Arts and Sciences, Harvard University, Cambridge, MA 02138.'}, {'ForeName': 'Neale', 'Initials': 'N', 'LastName': 'Mahoney', 'Affiliation': 'Department of Economics, Stanford University, Stanford, CA 94305.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2004759117']
1583,32719133,Objecting to experiments even while approving of the policies or treatments they compare.,"We resolve a controversy over two competing hypotheses about why people object to randomized experiments: 1) People unsurprisingly object to experiments only when they object to a policy or treatment the experiment contains, or 2) people can paradoxically object to experiments even when they approve of implementing either condition for everyone. Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.",2020,"Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.","['five preregistered within-subjects studies with 1,955 participants']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],,0.0207082,"Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.","[{'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Heck', 'Affiliation': 'Center for Translational Bioethics and Health Care Policy, Geisinger Health System, Danville, PA 17822; pheck1000@gmail.com.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Chabris', 'Affiliation': 'Autism and Developmental Medicine Institute, Geisinger Health System, Lewisburg, PA 17837.'}, {'ForeName': 'Duncan J', 'Initials': 'DJ', 'LastName': 'Watts', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, PA 19104.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Meyer', 'Affiliation': 'Center for Translational Bioethics and Health Care Policy, Geisinger Health System, Danville, PA 17822.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2009030117']
1584,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1585,32761160,Effects of Candesartan vs Lisinopril on Neurocognitive Function in Older Adults With Executive Mild Cognitive Impairment: A Randomized Clinical Trial.,"Importance


Observational studies have suggested that angiotensin receptor blockers are associated with a unique cognitive protection. It is unclear if this is due to reduced blood pressure (BP) or angiotensin receptors type 1 blockade.
Objective


To determine neurocognitive effects of candesartan vs lisinopril in older adults with mild cognitive impairment (MCI).
Design, Setting, and Participants


This randomized clinical trial included participants aged 55 years or older with MCI and hypertension. Individuals were withdrawn from prior antihypertensive therapy and randomized in a 1 to 1 ratio to candesartan or lisinopril from June 2014 to December 2018. Participants underwent cognitive assessments at baseline and at 6 and 12 months. Brain magnetic resonance images were obtained at baseline and 12 months. This intent-to-treat study was double-blind and powered for a sample size accounting for 20% dropout. Data were analyzed from May to October 2019.
Interventions


Escalating doses of oral candesartan (up to 32 mg) or lisinopril (up to 40 mg) once daily. Open-label antihypertensive drug treatments were added as needed to achieve BP less than 140/90 mm Hg.
Main Outcomes and Measures


The primary outcome was executive function (measured using the Trail Making Test, Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research tool) and secondary outcomes were episodic memory (measured using the Hopkins Verbal Learning Test-Revised) and microvascular brain injury reflected by magnetic resonance images of white matter lesions.
Results


Among 176 randomized participants (mean [SD] age, 66.0 [7.8] years; 101 [57.4%] women; 113 [64.2%] African American), 87 were assigned to candesartan and 89 were assigned to lisinopril. Among these, 141 participants completed the trial, including 77 in the candesartan group and 64 in the lisinopril group. Although the lisinopril vs candesartan groups achieved similar BP (12-month mean [SD] systolic BP: 130 [17] mm Hg vs 134 [20] mm Hg; P = .20; 12-month mean [SD] diastolic BP: 77 [10] mm Hg vs 78 [11] mm Hg; P = .52), candesartan was superior to lisinopril on the primary outcome of executive function measured by Trail Making Test Part B (effect size [ES] = -12.8 [95% CI, -22.5 to -3.1]) but not Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research score (ES = -0.03 [95% CI, -0.08 to 0.03]). Candesartan was also superior to lisinopril on the secondary outcome of Hopkins Verbal Learning Test-Revised delayed recall (ES = 0.4 [95% CI, 0.02 to 0.8]) and retention (ES = 5.1 [95% CI, 0.7 to 9.5]).
Conclusions and Relevance


These findings suggest that in older adults with MCI, 1-year treatment with candesartan had superior neurocognitive outcomes compared with lisinopril. These effects are likely independent of the BP-lowering effect of candesartan.
Trial Registration


ClinicalTrials.gov Identifier: NCT01984164.",2020,", candesartan was superior to lisinopril on the primary outcome of executive function measured by Trail Making Test Part B (effect size [ES] = -12.8","['older adults with MCI', 'participants aged 55 years or older with MCI and hypertension', '176 randomized participants (mean [SD] age', '141 participants completed the trial, including 77 in the candesartan group and 64 in the lisinopril group', 'Hg vs 134 [20', 'Older Adults With Executive Mild Cognitive Impairment', 'older adults with mild cognitive impairment (MCI', '66.0 [7.8] years; 101 [57.4%] women; 113 [64.2%] African American']","['lisinopril vs candesartan', 'oral candesartan', 'Candesartan', 'candesartan or lisinopril', 'angiotensin receptor blockers', 'Candesartan vs Lisinopril', 'candesartan', 'candesartan vs lisinopril', 'lisinopril']","['SD] diastolic BP', 'Neurocognitive Function', 'executive function (measured using the Trail Making Test, Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research tool) and secondary outcomes were episodic memory (measured using the Hopkins Verbal Learning Test-Revised) and microvascular brain injury reflected by magnetic resonance images of white matter lesions', 'executive function measured by Trail Making Test Part B (effect size [ES', 'Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research score', 'Hopkins Verbal Learning Test-Revised delayed recall', 'blood pressure (BP', 'superior neurocognitive outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C2752009', 'cui_str': 'White matter lesion'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",176.0,0.234526,", candesartan was superior to lisinopril on the primary outcome of executive function measured by Trail Making Test Part B (effect size [ES] = -12.8","[{'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Hajjar', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Okafor', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'McDaniel', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Obideen', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dee', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Shokouhi', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Levey', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Goldstein', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.12252']
1586,32761890,Two-year outcomes after percutaneous coronary intervention with drug-eluting stents or bare-metal stents in elderly patients with coronary artery disease.,"OBJECTIVES


Report the results at 2 years of the patients included in the SENIOR trial.
BACKGROUND


Patients above 75 years of age represent a fast-growing population in the cathlab. In the SENIOR trial, patients treated by percutaneous coronary intervention (PCI) with drug eluting stent (DES) and a short duration of P2Y12 inhibitor (1 and 6 months for stable and unstable coronary syndromes, respectively) compared with bare metal stents (BMS) was associated with a 29% reduction in the rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR) at 1 year. The results at 2 years are reported here.
METHODS AND RESULTS


We randomly assigned 1,200 patients (596[50%] to the DES group and 604[50%] to the BMS group). At 2 years, the composite endpoint of all-cause mortality, MI, stroke and ID-TLR had occurred in 116 (20%) patients in the DES group and 131 (22%) patients in the BMS group (RR 0.90 [95%CI 0.72-1.13], p = .37). IDTLR occurred in 14 (2%) patients in the DES group and 41 (7%) patients in the BMS group (RR 0.35 [95%CI 0.16-0.60], p = .0002). Major bleedings (BARC 3-5) occurred in 27(5%) patients in both groups (RR 1.00, [95%CI 0.58-1.75], p = .99). Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52 [95%CI 0.01-1.95], p = .27).
CONCLUSION


Among elderly PCI patients, a strategy combining a DES together with a short duration of DAPT is associated with a reduction in revascularization up to 2 years compared with BMS with very few late events and without any increased in bleeding complications or stent thrombosis.",2020,"Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52","['2 years of the patients included in the SENIOR trial', 'elderly PCI patients', 'Patients above 75\u2009years of age represent a fast-growing population in the cathlab', 'elderly patients with coronary artery disease']","['DES', 'percutaneous coronary intervention with drug-eluting stents or bare-metal stents', 'bare metal stents (BMS', 'percutaneous coronary intervention (PCI) with drug eluting stent (DES']","['Stent thrombosis rates', 'bleeding complications or stent thrombosis', 'Major bleedings', 'TLR', 'rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR', 'composite endpoint of all-cause mortality, MI, stroke and ID', 'IDTLR', 'DES and BMS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]",1200.0,0.0960011,"Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lafont', 'Affiliation': 'Cardiology Department Hôpital Cochin, Assistance Publique-Hôpitaux de Paris and, Université de Paris, Paris, France.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Timone, Marseille, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Cardiology Department, University and Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Giorgios', 'Initials': 'G', 'LastName': 'Sideris', 'Affiliation': 'Cardiology Department Service de Cardiologie-Institut national de la santé et de la recherche médicale U942, Hôpital Lariboisiere, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Sasko', 'Initials': 'S', 'LastName': 'Kedev', 'Affiliation': 'Cardiology Department, University St Cyril and Methodius, Skopje, Macedonia.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hovasse', 'Affiliation': 'Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Garot', 'Affiliation': 'Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'El Mahmoud', 'Affiliation': 'Hôpital Ambroise Paré Assistance Publique-Hôpitaux de Paris, Université Versailles-Saint Quentin en Yvelines, Versailles, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Spaulding', 'Affiliation': 'Service de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université de Paris and Sudden Death Expert Center, Institut national de la santé et de la recherche médicale U990, Paris, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Helft', 'Affiliation': 'Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie et Institut hospitalo-universitaire, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France.'}, {'ForeName': 'José F', 'Initials': 'JF', 'LastName': 'Diaz Fernandez', 'Affiliation': 'Cardiology department, Juan Ramón Jiménez University Hospital, Huelva, Spain.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Pinar-Bermudez', 'Affiliation': 'Cardiology department, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.'}, {'ForeName': 'Josepa Mauri', 'Initials': 'JM', 'LastName': 'Ferre', 'Affiliation': 'Cardiology department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Commeau', 'Affiliation': 'Département de Cardiologie Interventionnelle, Polyclinique Les Fleurs, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Teiger', 'Affiliation': 'Service de Cardiologie, Hôpital Henri Mondor Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), Department of Public Health and Primary Care, Katholieke Universiteit Leuven, Leuven, Belgium, and Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': ""Interventional Cardiology Unit, Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Marie Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'CERC (Cardiovascular European Research Center), Massy, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Varenne', 'Affiliation': 'Cardiology Department Hôpital Cochin, Assistance Publique-Hôpitaux de Paris and, Université de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29159']
1587,32761909,Topical phenytoin effects on palatal wound healing.,"BACKGROUND


The clinical benefits of autogenous soft tissue grafts are countered by donor site morbidity. The aim of this prospective split-mouth clinical trial is to assess clinical, histological and patient outcomes following topical phenytoin (PHT) treatment of experimental palatal wounds.
METHODS


Systemically healthy adults were recruited. One 6 mm diameter wound (posterior) and one 4 mm diameter wound (anterior), each 1-1.5 mm deep, were created on both sides of the palate. Wounds on one randomly chosen side received 10% phenytoin USP and contralateral wounds received carrier alone. Biopsies were harvested from anterior wounds (Day 1 or Day 5) and were routinely processed for histology. Posterior wounds were left undisturbed to clinically evaluate healing (using photographs and Healing Score Index) on Days 1, 5, 14, and 21. Questionnaires were used to assess patient-centered outcomes. Data analysis was performed using generalized logistic and generalized linear mixed models.
RESULTS


Twenty participants completed all visits. 30% of participants reported more pain on control side than the PHT side at Day 1 (P = 0.014). PHT treated sites were more likely to not exhibit swelling (OR = 9.35; P = 0.009) and to not experience pain on palpation (OR = 6.278; P = 0.007). PHT significantly and time-dependently affected granulation tissue appearance (P = 0.004). Histologically, there were no significant differences between control and PHT, at any time point (P ≥ 0.853).
CONCLUSIONS


The results of the present study, the first one to report on topical PHT as palatal wound treatment, suggest that PHT application on palatal wounds could result in improved healing outcomes.",2020,PHT treated sites were more likely to not exhibit swelling (OR = 9.35; p = 0.009) and to not experience pain on palpation (OR = 6.278; p = 0.007).,"['experimental palatal wounds', '20 participants completed all visits', 'Systemically healthy adults were recruited']","['topical phenytoin (PHT', 'phenytoin USP and contralateral wounds received carrier alone', 'Topical phenytoin']","['pain on control side', 'healing outcomes', 'granulation tissue appearance', 'palatal wound healing']","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}]",1.0,0.0375099,PHT treated sites were more likely to not exhibit swelling (OR = 9.35; p = 0.009) and to not experience pain on palpation (OR = 6.278; p = 0.007).,"[{'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Division of Periodontology, College of Dentistry, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'McAuley', 'Affiliation': 'College of Pharmacy, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Dimitris N', 'Initials': 'DN', 'LastName': 'Tatakis', 'Affiliation': 'Division of Periodontology, College of Dentistry, Ohio State University, Columbus, Ohio, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0340']
1588,32758281,"Correction to: A nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: a study protocol for a randomized controlled trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"['stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China']",['nurse-led health coaching intervention'],[],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0630952,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Shuanglan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia.'}, {'ForeName': 'Lily Dongxia', 'Initials': 'LD', 'LastName': 'Xiao', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia. lily.xiao@flinders.edu.au.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Chamberlain', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia.'}]",Trials,['10.1186/s13063-020-04609-3']
1589,32758684,Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.,"OBJECTIVE


To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars.
METHODS


One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots.
RESULTS


The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups.
CONCLUSIONS


After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).",2020,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","['150 4-8-year-old children', 'primary molars']","['glass ionomer cements (GICs', 'restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM', 'Atraumatic Restorative Treatment (ART', 'Fuji IX']","['overall survival rate of occlusal ART restorations', 'Restoration survival', '2-year survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3529286', 'cui_str': 'Maxxion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0977731,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Olegário', 'Affiliation': 'Department of Public and Child Dental Health, Dublin Dental University Hospital, University of Dublin, Trinity College, Dublin, Ireland; Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nathalia de Miranda', 'Initials': 'NM', 'LastName': 'Ladewig', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Clarissa Calil', 'Initials': 'CC', 'LastName': 'Bonifácio', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Carlos Pettorossi', 'Initials': 'JCP', 'LastName': 'Imparato', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103446']
1590,32700393,The effects of ertugliflozin on β-cell function: Pooled analysis from four phase 3 randomized controlled studies.,"AIM


To identify potential predictors and mediators of changes in β-cell function in response to ertugliflozin treatment in people with type 2 diabetes mellitus (T2DM).
PARTICIPANTS AND METHODS


Data from patients with T2DM randomized to ertugliflozin (5 or 15 mg; observations from both doses were pooled) or placebo in four phase 3 clinical studies (clinicaltrials.gov: NCT01958671, NCT02226003, NCT02036515, NCT02099110) were pooled and analysed. Change from baseline in β-cell function at week 26 was assessed, and its potential predictors and mediators were analysed using linear and multiple regression analyses.
RESULTS


Compared with placebo, ertugliflozin improved β-cell function when assessed by mean percent change from baseline in homeostatic model assessment of β-cell function (HOMA-%β; ertugliflozin: 14.7%, 95% confidence interval [CI] 12.3, 17.1; placebo: -0.4%, 95% CI -3.4, 2.5], but not when assessed by change in C-peptide index following a mixed meal tolerance test. Change in HOMA-%β correlated with change from baseline in glycated haemoglobin (HbA1c) and treatment with ertugliflozin, and weakly with change from baseline in body weight. In the ertugliflozin group, change in HOMA-%β correlated with baseline fasting plasma glucose (FPG; r = 0.235, P < 0.001), baseline HbA1c (r = 0.138, P < 0.001), baseline homeostatic model assessment of insulin resistance (HOMA-IR; r = 0.162, P < 0.01), and baseline HOMA-%β (r = -0.321, P < 0.001) in linear regression analyses. Multiple regression analyses yielded similar results.
DISCUSSION


In people with T2DM, ertugliflozin treatment improved fasting β-cell function, but no effect on postprandial β-cell function was observed in this analysis. Improvement in HOMA-%β was predicted by high baseline FPG, HbA1c, HOMA-IR, and low baseline HOMA-%β, and mediated by ertugliflozin treatment, and improved HbA1c and body weight.",2020,"Improvement in HOMA-%β was predicted by high baseline FPG, HbA1C, HOMA-IR, and low baseline HOMA-%β, and mediated by ertugliflozin treatment, and improved HbA1c and body weight.","['Data from patients with T2DM randomized to', 'people with type 2 diabetes mellitus (T2DM']","['ertugliflozin', 'ertugliflozin treatment', 'placebo, ertugliflozin', 'placebo']","['homeostatic model assessment', 'fasting β-cell function', 'Change in HOMA-%β', 'β-cell function', 'change in HOMA-%β correlated with baseline fasting plasma glucose', 'high baseline FPG, HbA1C, HOMA-IR, and low baseline HOMA-%β, and mediated by ertugliflozin treatment, and improved HbA1c and body weight', 'postprandial β-cell function', 'baseline HOMA of insulin resistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.125365,"Improvement in HOMA-%β was predicted by high baseline FPG, HbA1C, HOMA-IR, and low baseline HOMA-%β, and mediated by ertugliflozin treatment, and improved HbA1c and body weight.","[{'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Clinical Development and Operation, Pfizer Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': ""Global Clinical Development: Diabetes, Endocrinology & Women's Health, Merck & Co., Inc., Kenilworth, New Jersey, USA.""}, {'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Calle', 'Affiliation': 'Internal Medicine Research Unit, Worldwide Research, Development & Medical, Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Scientific Affairs, Merck & Co., Inc., Kenilworth, New Jersey.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14149']
1591,32708600,Impact of Exercises and Chair Massage on Musculoskeletal Pain of Young Musicians.,"Due to the occurrence among musicians of musculoskeletal problems associated with playing a musical instrument, it is necessary to use prophylaxis. The aim of the study was to compare the effectiveness of two physioprophylaxis methods: chair massage and an original set of exercises. The study lasted four weeks and consisted of eight 15-min meetings (chair massage/exercises). The study was conducted on 44 music students assigned to three groups (chair massage/exercise program/control group). The algometric measurements and questionnaire were conducted. Health problems associated with playing an instrument was reported by 86.4% of the participants. The largest changes in pain threshold concerned the trigger points of the muscles with the highest pain sensitivity, i.e., upper part of trapezius ones, and reached 25-34% in relation to the initial values. For the trigger points of the levator scapulae and lower part of trapezius, the increase in the pain threshold was between 20 and 28%. Raising the pain threshold was observed both after each session and meeting by meeting, and these differences were most visible in the massage group. This effect was particularly visible from the fourth treatment. Chair massage and exercise should be used regularly, and significant results can be obtained after two weeks.",2020,"For the trigger points of the levator scapulae and lower part of trapezius, the increase in the pain threshold was between 20 and 28%.","['44 music students assigned to three groups ', 'Musculoskeletal Pain of Young Musicians']","['Exercises and Chair Massage', 'physioprophylaxis methods: chair massage', 'Chair massage and exercise', 'chair massage/exercise program/control group']",['pain threshold'],"[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",44.0,0.0195533,"For the trigger points of the levator scapulae and lower part of trapezius, the increase in the pain threshold was between 20 and 28%.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cygańska', 'Affiliation': 'Faculty of Rehabilitation, Józef Piłsudski University of Physical Education in Warsaw, Poland, Marymoncka 34, 00-968 Warsaw, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Truszczyńska-Baszak', 'Affiliation': 'Faculty of Rehabilitation, Józef Piłsudski University of Physical Education in Warsaw, Poland, Marymoncka 34, 00-968 Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Tomaszewski', 'Affiliation': 'Faculty of Physical Education, Józef Piłsudski University of Physical Education in Warsaw, Poland, Marymoncka 34, 00-968 Warsaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145128']
1592,32708055,The Effect of Inquiry-Based Stress Reduction on Teacher Burnout: A Controlled Trial.,"Burnout is a well-known phenomenon with significant social, biological and economic costs. In particular, teacher burnout is associated with unfavorable mental health outcomes and economic costs due to reduced hours and teacher turnover. This study investigated the effect of an Inquiry-Based Stress Reduction (IBSR) cognitive-reframing program on teacher burnout using a quasi-experimental design. Fifty-three teachers participated in a prospective intervention with a passive control group. The intervention group completed a 12-week IBSR program with 4.5 h of weekly engagement. Relative to control, teachers in the intervention group showed greater improvements in emotional exhaustion (18.8 ± 5.2 to 15.9 ± 5.7 vs. 16.0 ± 4.8 to 17.4 ± 4.8;  p  = 0.01) and personal accomplishment (21.8 ± 5.0 to 24.6 ± 4.3 vs. 21.9 ± 4.5 to 22.8 ± 4.3;  p  = 0.04). Significant correlations were found between change in emotional exhaustion and negative affect (positive correlation; r = 0.32;  p  = 0.034) and between personal accomplishment and perceived stress (negative correlation; r = -0.451;  p  = 0.002). This study demonstrates the potential of IBSR to improve teacher well-being. Future randomized studies are needed to evaluate the causality of IBSR in reducing burnout among teachers and other high-stress workplaces.",2020,"Relative to control, teachers in the intervention group showed greater improvements in emotional exhaustion (18.8 ± 5.2 to 15.9 ± 5.7 vs. 16.0 ± 4.8 to 17.4 ± 4.8;  p  = 0.01) and personal accomplishment (21.8 ± 5.0 to 24.6 ± 4.3 vs. 21.9 ± 4.5 to 22.8 ± 4.3;  p  = 0.04).",['Fifty-three teachers participated in a prospective intervention with a passive control group'],"['Inquiry-Based Stress Reduction (IBSR) cognitive-reframing program', 'IBSR program with 4.5 h of weekly engagement', 'Inquiry-Based Stress Reduction']","['personal accomplishment', 'emotional exhaustion', 'personal accomplishment and perceived stress']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",53.0,0.0193901,"Relative to control, teachers in the intervention group showed greater improvements in emotional exhaustion (18.8 ± 5.2 to 15.9 ± 5.7 vs. 16.0 ± 4.8 to 17.4 ± 4.8;  p  = 0.01) and personal accomplishment (21.8 ± 5.0 to 24.6 ± 4.3 vs. 21.9 ± 4.5 to 22.8 ± 4.3;  p  = 0.04).","[{'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Schnaider-Levi', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.'}, {'ForeName': 'Ariel B', 'Initials': 'AB', 'LastName': 'Ganz', 'Affiliation': 'Department of Genetics, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Zafrani', 'Affiliation': ""Begin High School, John Kennedy Street 8, Rosh Ha'Ayin 4852028, Israel.""}, {'ForeName': 'Zehavit', 'Initials': 'Z', 'LastName': 'Goldman', 'Affiliation': ""Begin High School, John Kennedy Street 8, Rosh Ha'Ayin 4852028, Israel.""}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Mitnik', 'Affiliation': ""Begin High School, John Kennedy Street 8, Rosh Ha'Ayin 4852028, Israel.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rolnik', 'Affiliation': 'Department of Genetics, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Lev-Ari', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.'}]",Brain sciences,['10.3390/brainsci10070468']
1593,32716114,"A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma.","A previous randomized phase 2 study of hepatocellular carcinoma revealed that the c-Met inhibitor tivantinib as second-line treatment significantly prolonged progression-free survival in a subpopulation whose tumor samples highly expressed c-Met (MET-high). Accordingly, this phase 3 study was conducted to evaluate the efficacy of tivantinib as a second-line treatment for Japanese patients with MET-high hepatocellular carcinoma. This randomized, double-blind, placebo-controlled study was conducted at 60 centers in Japan. Hepatocellular carcinoma patients with one prior sorafenib treatment and those with MET-high tumor samples were eligible for inclusion. Registered patients were randomly assigned to either the tivantinib or placebo group at a 2:1 ratio and were treated with twice-a-day oral tivantinib (120 mg bid) or placebo until the discontinuation criteria were met. The primary endpoint was progression-free survival while the secondary endpoints included overall survival and safety. Between January 2014 and June 2016, 386 patients provided consent, and 195 patients were randomized to the tivantinib (n = 134) or placebo (n = 61) group. Median progression-free survival was 2.8 (95% confidence interval: 2.7-2.9) and 2.3 (1.5-2.8) mo in the tivantinib and placebo groups, respectively (hazard ratio = 0.74, 95% confidence interval: 0.52-1.04, P = .082). Median overall survival was 10.3 (95% confidence interval: 8.1-11.6) and 8.5 (6.2-11.4) mo in the tivantinib and placebo group, respectively (hazard ratio = 0.82, 95% confidence interval: 0.58-1.15). The most common tivantinib-related grade ≥3 adverse events were neutropenia (31.6%), leukocytopenia (24.8%), and anemia (12.0%). This study did not confirm the significant efficacy of tivantinib as a second-line treatment for Japanese patients with MET-high hepatocellular carcinoma. (NCT02029157).",2020,"Median progression-free survival was 2.8 (95% confidence interval: 2.7-2.9) and 2.3 (1.5-2.8) months in the tivantinib and placebo groups, respectively (hazard ratio=0.74, 95% confidence interval: 0.52-1.04, p=0.082).","['Between January 2014 and June 2016, 386 patients provided consent, and 195 patients', '60 centers in Japan', 'Japanese patients with MET-high hepatocellular carcinoma', 'Japanese Patients with MET-high Hepatocellular Carcinoma', 'Hepatocellular carcinoma patients with one prior sorafenib treatment and those with MET-high tumor samples were eligible for inclusion']","['tivantinib', 'Placebo', 'tivantinib or placebo', 'placebo']","['Median overall survival', 'neutropenia', 'Median progression-free survival', 'leukocytopenia', 'progression-free survival', 'anemia', 'overall survival and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.681592,"Median progression-free survival was 2.8 (95% confidence interval: 2.7-2.9) and 2.3 (1.5-2.8) months in the tivantinib and placebo groups, respectively (hazard ratio=0.74, 95% confidence interval: 0.52-1.04, p=0.082).","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Michihisa', 'Initials': 'M', 'LastName': 'Moriguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Department of Gastroenterology and Oncology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yoshiji', 'Affiliation': 'Department of Gastroenterology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hino', 'Affiliation': 'Department of Hepatology and Pancreatology, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Oikawa', 'Affiliation': 'Department of Internal Medicine, Division of Hepatology, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Department of Hepatology, Aso Iizuka Hospital, Fukuoka, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yasuchika', 'Affiliation': 'Department of Surgery, Division of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ido', 'Affiliation': 'Department of Gastroenterology, Kagoshima University Medical and Dental Hospital, Kagoshima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'R&D Division, Kyowa Kirin Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakashima', 'Affiliation': 'R&D Division, Kyowa Kirin Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kyorin University, Tokyo, Japan.'}]",Cancer science,['10.1111/cas.14582']
1594,32717956,Impact of Trunk Resistance and Stretching Exercise on Fall-Related Factors in Patients with Parkinson's Disease: A Randomized Controlled Pilot Study.,"BACKGROUND


This study aimed to examine the effect of a 12-week progressive trunk resistance and stretching exercise program on fall-related factors in patients with Parkinson's disease (PD).
METHODS


A randomized study assessed a progressive trunk resistance and stretching exercise program over a 12-week period. A total of 17 patients with PD participated and wererandomly allocated into an exercise group ( n  = 10) or a control group ( n  = 7). Participants in the exercise group completed the exercise program in 60- to 90-min sessions for three days per week. Primary and secondary outcome measures included the trunk mobility scale, functional fitness test, standing balance, and sit-to-walk test.
RESULTS


The exercise group showed improvements in functional fitness, trunk mobility, standing balance, and dynamic stability compared with the control group (all  p  < 0.05). The 2.44 m timed up and go test (odds ratio (OR): 0.125) and the 2 min step test (OR: 10.584) of the functional fitness test, and the first-step length (OR: 3.558) and first-toe clearance height (OR: 4.777) of the sit-to-walk test, were different between the groups following the exercise program.
CONCLUSION


This 12-week exercise program improved fall-related factors in patients with PD and may lead to prevention of fall-related injuries.",2020,"The exercise group showed improvements in functional fitness, trunk mobility, standing balance, and dynamic stability compared with the control group (all  p  < 0.05).","[""patients with Parkinson's disease (PD"", ""Patients with Parkinson's Disease"", '17 patients with PD', 'patients with PD and may lead to prevention of fall-related injuries']","['exercise program', 'progressive trunk resistance and stretching exercise program', 'Trunk Resistance and Stretching Exercise']","['functional fitness, trunk mobility, standing balance, and dynamic stability', 'trunk mobility scale, functional fitness test, standing balance, and sit-to-walk test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",17.0,0.0209581,"The exercise group showed improvements in functional fitness, trunk mobility, standing balance, and dynamic stability compared with the control group (all  p  < 0.05).","[{'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Youm', 'Affiliation': 'Department of Health Care and Science, College of Health Sciences, Dong-A University, Saha-gu, Busan 49315, Korea.'}, {'ForeName': 'Youkyung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Biomechanics Laboratory, College of Health Sciences, Dong-A University, Saha-gu, Busan 49315, Korea.'}, {'ForeName': 'Byungjoo', 'Initials': 'B', 'LastName': 'Noh', 'Affiliation': 'Department of Health Care and Science, College of Health Sciences, Dong-A University, Saha-gu, Busan 49315, Korea.'}, {'ForeName': 'Myeounggon', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Biomechanics Laboratory, College of Health Sciences, Dong-A University, Saha-gu, Busan 49315, Korea.'}, {'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Biomechanics Laboratory, College of Health Sciences, Dong-A University, Saha-gu, Busan 49315, Korea.'}, {'ForeName': 'Sang-Myung', 'Initials': 'SM', 'LastName': 'Cheon', 'Affiliation': 'Department of Neurology, School of Medicine, Dong-A University, Dongdaesin-dong 3-ga, Seo-gu, Busan 49201, Korea.'}]","Sensors (Basel, Switzerland)",['10.3390/s20154106']
1595,32718044,The Effectiveness of Laser-Activated Irrigation on the Apical Microleakage Qualities of MTA Repair HP and NeoMTA Plus in Simulated Immature Teeth: A Comparative Study.,"There are limited data regarding the potential effect of erbium, chromium: yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser-activated irrigation (LAI) on the microleakage qualities of calcium silicate-based cements. The objective of the present study was to assess the effect of LAI on the microleakage qualities of MTA Repair HP (MTA-HP) and NeoMTA Plus (Neo) used in root-end filling and to compare the antimicrobial effectiveness of MTA- HP. Two experimental sets were conducted: antimicrobial activity (agar diffusion test/at 24, 48 h) and microleakage (glucose leakage model/at 1st, 10th, 20th days). Antimicrobial activities of MTA-HP, Neo, Biodentine, ProRoot and MTA Angelus were evaluated, and inhibition zones were observed not only against a range of Gram-positive and Gram-negative bacteria but also against yeast at 48h. For microleakage evaluation, fifty teeth were prepared to simulate the clinical situation where the root-tips (apex) are open, and randomly divided into two experimental groups (n = 20/group) according to the cement type ( MTA-HP  and  Neo ), and two control (n = 5/group) groups. Each experimental group was further divided into two subgroups (n = 10/group) with respect to LAI:  MTA-HP ,  L-HP ,  Neo ,  L-Neo . A statistical difference was only detected between Neo and L-HP groups on day 1. Subsequently, MTA-HP exhibited superior microleakage quality compared to Neo in the short-term. Er,Cr:YSGG laser-activated irrigation could be used as a reliable technique without creating adverse effects on the sealing abilities of MTA Repair HP and NeoMTA Plus.",2020,"Er,Cr:YSGG laser-activated irrigation could be used as a reliable technique without creating adverse effects on the sealing abilities of MTA Repair HP and NeoMTA",['Simulated Immature Teeth'],"['Er,Cr:YSGG) laser-activated irrigation (LAI', 'Laser-Activated Irrigation', 'erbium, chromium: yttrium-scandium-gallium-garnet', 'MTA Repair HP (MTA-HP) and NeoMTA Plus (Neo', 'MTA- HP']","['microleakage quality', 'antimicrobial activity']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0036274', 'cui_str': 'Scandium'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1271650', 'cui_str': 'Antimicrobial activity'}]",50.0,0.0163903,"Er,Cr:YSGG laser-activated irrigation could be used as a reliable technique without creating adverse effects on the sealing abilities of MTA Repair HP and NeoMTA","[{'ForeName': 'Serenad', 'Initials': 'S', 'LastName': 'Çırakoğlu', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry Near East University, 99138 Nicosia, North Cyprus.'}, {'ForeName': 'Buket', 'Initials': 'B', 'LastName': 'Baddal', 'Affiliation': 'Department of Medical Microbiology and Clinical Microbiology, Faculty of Medicine, Near East University, 99138 Nicosia, North Cyprus.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'İslam', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry Near East University, 99138 Nicosia, North Cyprus.'}]","Materials (Basel, Switzerland)",['10.3390/ma13153287']
1596,32723804,"Efficacy and Safety of Daprodustat Compared with Darbepoetin Alfa in Japanese Hemodialysis Patients with Anemia: A Randomized, Double-Blind, Phase 3 Trial.","BACKGROUND AND OBJECTIVES


Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates genes related to iron metabolism. The efficacy (noninferiority) and safety of daprodustat compared with standard therapy (darbepoetin alfa) was evaluated.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This was a randomized, phase 3, double-blind, active-control study in Japanese patients receiving hemodialysis with anemia of CKD. Participants' treatment was switched from current erythropoiesis-stimulating agents (ESAs) to daprodustat 4 mg once daily or darbepoetin alfa 10-60  μ g once weekly (on the basis of the prestudy ESA dose). Dose was adjusted every 4 weeks for daprodustat or every 2 weeks for darbepoetin alfa, according to a protocol-specified algorithm. The primary end point was mean hemoglobin during weeks 40-52 in the intent-to-treat population.
RESULTS


Of 332 participants screened, 271 participants were randomized (safety evaluation: 271 participants; efficacy evaluation: 267 intent-to-treat population). The mean hemoglobin during weeks 40-52 were maintained within the target range in both groups (10.9 g/dl [95% confidence interval (95% CI), 10.8 to 11.0] for daprodustat, and 10.8 g/dl [95% CI, 10.7 to 11.0] for darbepoetin alfa). Daprodustat was noninferior to darbepoetin alfa, as the lower bound of the confidence interval for the treatment difference (0.1 g/dl; 95% CI, -0.1 to 0.2 g/dl) was greater than the noninferiority criterion of -1.0 g/dl. For most participants, hemoglobin was maintained within the target range (10.0-12.0 g/dl) during weeks 40-52 (88% daprodustat; 90% darbepoetin alfa). Geometric mean hepcidin levels decreased more at week 52 with daprodustat (-37%; 95% CI, -49 to -23) than with darbepoetin alfa (-20%; 95% CI, -36 to -1), and an increase in total iron-binding capacity was observed in the daprodustat group. Frequency of adverse events were generally similar between daprodustat and darbepoetin alfa.
CONCLUSIONS


Oral daprodustat was noninferior to darbepoetin alfa as measured by mean hemoglobin over weeks 40-52 in Japanese patients receiving hemodialysis switched from ESAs.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


201754, Clinicaltrials.gov, NCT02969655.",2020,"Geometric mean hepcidin levels decreased more at week 52 with daprodustat (-37%; 95% CI, -49 to -23) than with darbepoetin alfa (-20%; 95% CI, -36 to -1), and an increase in total iron-binding capacity was observed in the daprodustat group.","['Japanese Hemodialysis Patients with Anemia', 'Japanese patients receiving hemodialysis switched from ESAs', 'Japanese patients receiving hemodialysis with anemia of CKD', '332 participants screened, 271 participants were randomized', '271 participants; efficacy evaluation: 267 intent-to-treat population']","['current erythropoiesis-stimulating agents (ESAs) to daprodustat 4 mg once daily or darbepoetin alfa', 'standard therapy (darbepoetin alfa', 'Daprodustat Compared with Darbepoetin Alfa']","['Efficacy and Safety', 'Geometric mean hepcidin levels', 'mean hemoglobin', 'hemoglobin', 'total iron-binding capacity', 'Frequency of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0700379', 'cui_str': 'Total iron binding capacity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",271.0,0.415077,"Geometric mean hepcidin levels decreased more at week 52 with daprodustat (-37%; 95% CI, -49 to -23) than with darbepoetin alfa (-20%; 95% CI, -36 to -1), and an increase in total iron-binding capacity was observed in the daprodustat group.","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Yonekawa', 'Affiliation': 'Medicines Development, Japan Development, GlaxoSmithKline, Tokyo, Japan taeko.yonekawa@gsk.com.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Okuda', 'Affiliation': 'Medicines Development, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kawamatsu', 'Affiliation': 'Clinical Operations, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Onoue', 'Affiliation': 'Biomedical Data Sciences, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Endo', 'Affiliation': 'Medicines Development, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Katsutoshi', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Clinical Pharmacology, Japan Development, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Cobitz', 'Affiliation': 'Medicine Delivery, GlaxoSmithKline, Collegeville, Pennsylvania.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.16011219']
1597,32729749,Cost-utility analysis of normothermic liver perfusion with the OrganOx  metra  compared to static cold storage in the United Kingdom.,"BACKGROUND


Rising numbers of patients on the liver transplant waiting list has led to the utilization of organs from higher-risk donors that are more likely to be discarded and are prone to post-transplant complications. Storage and transportation of these livers at low temperatures can cause damage. OrganOx  metra  is a portable device intended to preserve and maintain the donated liver in normothermic conditions for up to 24 h prior to transplantation.
OBJECTIVE


To evaluate the cost-utility of normothermic machine perfusion with OrganOx  metra  in liver transplantation compared to the current practice of static cold storage (SCS).
METHODS


A de novo decision analytic model (a decision tree along with a Markov model), based on current treatment pathways, was developed to estimate the costs and outcomes. Results from a randomized clinical trial and national standard sources were used to inform the model. Costs were estimated from the National Health Service and Personal Social Services perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to explore uncertainty surrounding input parameters.
RESULTS


Over a lifetime time horizon, liver transplantation with OrganOx  metra  was more costly and more effective than the current practice of static cold storage. The total costs per patient were £37,370 vs £46,711, and the total effectiveness per patient was 9.09 QALYs vs 10.27 QALYs for SCS and OrganOx  metra  groups, respectively. The estimated ICER was £7,876 per each QALY gained. Results from the PSA showed that use of OrganOx  metra  has 99% probability of being cost-effective at a £20,000 willingness-to-pay threshold. OrganOx  metra  led to the utilization of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events.
CONCLUSIONS


Use of OrganOx  metra  for the perfusion and transportation of livers prior to transplantation is a cost-effective strategy. KEY POINTS FOR DECISION MAKERS Introduction of OrganOx  metra  into NHS could increase the utilisation of donated livers with patients experiencing lower rates of early allograft dysfunction and adverse events, compared with current practice. Results of the economic analysis indicate that the OrganOx  metra  is highly likely to be cost-effective and result in improved patient outcomes.",2020,OrganOx metra led to the utilisation of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events.,[],"['OrganOx metra', 'normothermic machine perfusion with OrganOx metra', 'OrganOx']","['total costs per patient', 'early allograft dysfunction and adverse events']",[],"[{'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.035054,OrganOx metra led to the utilisation of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Javanbakht', 'Affiliation': 'Optimax Access UK Ltd, University of Southampton Science Park, Chilworth, UK.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Mashayekhi', 'Affiliation': 'Optimax Access UK Ltd, University of Southampton Science Park, Chilworth, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Trevor', 'Affiliation': 'School of Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Branagan-Harris', 'Affiliation': 'Device Access UK Ltd, Market Access Consultancy, University of Southampton Science Park, Chilworth, UK.'}, {'ForeName': 'Jowan', 'Initials': 'J', 'LastName': 'Atkinson', 'Affiliation': 'Device Access UK Ltd, Market Access Consultancy, University of Southampton Science Park, Chilworth, UK.'}]",Journal of medical economics,['10.1080/13696998.2020.1804391']
1598,32726899,Effects of a Gluteal Muscles Specific Exercise Program on the Vertical Jump.,"The vertical jump is a complex movement where many factors are involved in the final result. Currently, how a specific exercise program for gluteal muscles can affect the vertical jump is unknown. So, the aim of this study was to examine the effect of a specific exercise program for the gluteal muscles on a vertical jump. Forty-nine amateur athletes completed an 8-week program. The experimental group received a specific gluteal muscle training program in addition to their regular training routine, whereas the control group received their regular training routine. Jump height, flight time, speed and power were assessed (baseline, postintervention, and 4-week follow-up). Repeated-measures analyses of variance were conducted with ∝ ≤ 0.05. We calculated Eta squared effect sizes with 95% confidence intervals. Measurements at 8 weeks revealed significant increases in the experimental group compared to the control group for the values: jump height ( p  < 0.05) (experimental group = 17.15%; control group = 3.09%), flight time ( p  < 0.001) (experimental group = 7.98%; control group = 3.52%), speed ( p  < 0.01) (experimental group = 1.96%; control group = 1.83%) and power ( p  < 0.05) (experimental group = 4.43%; control group = 0.32%). However, at follow-up, these changes were not maintained. These data suggest that this specific training protocol for the gluteal muscles is effective in order to improve vertical jump performance in amateur athletes who use the vertical jump in their routine training habits.",2020,"Measurements at 8 weeks revealed significant increases in the experimental group compared to the control group for the values: jump height ( p  < 0.05) (experimental group = 17.15%; control group = 3.09%), flight time ( p  < 0.001) (experimental group = 7.98%; control group = 3.52%), speed ( p  < 0.01) (experimental group = 1.96%; control group = 1.83%) and power ( p  < 0.05) (experimental group = 4.43%; control group = 0.32%).","['Forty-nine amateur athletes completed an 8-week program', 'amateur athletes who use the vertical jump in their routine training habits']","['specific exercise program', 'Gluteal Muscles Specific Exercise Program', 'specific gluteal muscle training program in addition to their regular training routine, whereas the control group received their regular training routine']","['Jump height, flight time, speed and power', 'vertical jump performance', 'flight time']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",49.0,0.0148403,"Measurements at 8 weeks revealed significant increases in the experimental group compared to the control group for the values: jump height ( p  < 0.05) (experimental group = 17.15%; control group = 3.09%), flight time ( p  < 0.001) (experimental group = 7.98%; control group = 3.52%), speed ( p  < 0.01) (experimental group = 1.96%; control group = 1.83%) and power ( p  < 0.05) (experimental group = 4.43%; control group = 0.32%).","[{'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gallego-Izquierdo', 'Affiliation': 'Physiotherapy and Pain Group, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Vidal-Aragón', 'Affiliation': 'Physical Therapist, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Calderón-Corrales', 'Affiliation': 'Physical Therapist, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Acuña', 'Affiliation': 'Physical Therapist, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Achalandabaso-Ochoa', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain..'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Aibar-Almazán', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain..'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez-Amat', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain..'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Physiotherapy and Pain Group, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17155383']
1599,32727086,"Evaluating the Implementation and Effectiveness of the SWITCH-MS: An Ecological, Multi-Component Adolescent Obesity Prevention Intervention.","Background : The purpose of this study was to evaluate the implementation and effectiveness of an ecological, multi-component adolescent obesity prevention intervention called School Wellness Integration Targeting Child Health-Middle School (SWITCH-MS).  Methods : Following the effectiveness-implementation hybrid type 3 quasi-experimental design, seven middle schools (377 students) in Iowa, United States, were stratified into ""experienced"" ( n  = 3; 110 students) or ""inexperienced"" ( n  = 4; 267 students) groups to receive the 12-week SWITCH-MS intervention. To evaluate implementation, school informants ( n  = 10) responded to a survey and students completed behavioral tracking in the classroom on a website. For effectiveness evaluation, students in 6th, 7th, and 8th grades completed a validated questionnaire before and after intervention, to measure behaviors of physical activity (PA; ""Do""), screen-based activity (""View""), and fruits and vegetable consumption (""Chew"").  Results : The two groups of schools showed similar levels of implementation for best practices, awareness, and engagement. Behavioral tracking rate favored the experienced schools early on (47.5% vs. 11.7%), but differences leveled off in weeks 3-12 (sustained at 30.1-44.3%). Linear mixed models demonstrated significant time effects for ""Do"" (at school and out of school;  p  < 0.01) and ""View"" behaviors ( p  = 0.02), after controlling for student- and school-level covariates.  Conclusions : This study demonstrates that prior experience with SWITCH-MS may not be a prominent factor for implementation and effectiveness, although greater experience is associated with favorable behavioral tracking when the intervention is first launched.",2020,"Linear mixed models demonstrated significant time effects for ""Do"" (at school and out of school;  p  < 0.01) and ""View"" behaviors ( p  = 0.02), after controlling for student- and school-level covariates.  ","['seven middle schools (377 students) in Iowa, United States, were stratified into ""experienced"" ( n  = 3; 110 students) or ""inexperienced"" ( n  = 4; 267 students) groups to']",['receive the 12-week SWITCH-MS intervention'],"['Behavioral tracking rate', 'similar levels of implementation for best practices, awareness, and engagement', 'View"" behaviors', 'behaviors of physical activity (PA; ""Do""), screen-based activity (""View""), and fruits and vegetable consumption (""Chew']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}]",377.0,0.0127318,"Linear mixed models demonstrated significant time effects for ""Do"" (at school and out of school;  p  < 0.01) and ""View"" behaviors ( p  = 0.02), after controlling for student- and school-level covariates.  ","[{'ForeName': 'Senlin', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA 70803, USA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics, & Health, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Gabriella M', 'Initials': 'GM', 'LastName': 'McLoughlin', 'Affiliation': 'College of Human Sciences and Education, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'Spyridoula', 'Initials': 'S', 'LastName': 'Vazou', 'Affiliation': 'College of Human Sciences and Education, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Lanningham-Foster', 'Affiliation': 'College of Human Sciences and Education, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Gentile', 'Affiliation': 'College of Human Sciences and Education, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Dzewaltowski', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE 69198, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17155401']
1600,32732787,Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial.,"BACKGROUND


Telephone call programs are a common intervention used to improve patients' transition to outpatient care after hospital discharge.
OBJECTIVE


To examine the impact of a follow-up telephone call program as a readmission reduction initiative.
RESEARCH DESIGN


Pragmatic randomized controlled real-world effectiveness trial.
SUBJECTS


We enrolled and randomized all patients discharged home from a hospital general medicine service to a follow-up telephone call program or usual care discharge. Patients discharged against medical advice were excluded. The intervention was a hospital program, delivering a semistructured follow-up telephone call from a nurse within 3-7 days of discharge, designed to assess understanding and provide education, and assistance to support discharge plan implementation.
MEASURES


Our primary endpoint was hospital inpatient readmission within 30 days identified by the electronic health record. Secondary endpoints included observation readmission, emergency department revisit, and mortality within 30 days, and patient experience ratings.
RESULTS


All 3054 patients discharged home were enrolled and randomized to the telephone call program (n=1534) or usual care discharge (n=1520). Using a prespecified intention-to-treat analysis, we found no evidence supporting differences in 30-day inpatient readmissions [14.9% vs. 15.3%; difference -0.4 (95% confidence interval, 95% CI), -2.9 to 2.1; P=0.76], observation readmissions [3.8% vs. 3.6%; difference 0.2 (95% CI, -1.1 to 1.6); P=0.74], emergency department revisits [6.1% vs. 5.4%; difference 0.7 (95% CI, -1.0 to 2.3); P=0.43], or mortality [4.4% vs. 4.9%; difference -0.5 (95% CI, -2.0 to 1.0); P=0.51] between telephone call and usual care groups.
CONCLUSIONS


We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.",2020,We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.,"['Patients discharged against medical advice were excluded', ""patients' transition to outpatient care after hospital discharge"", 'All 3054 patients discharged home were enrolled and randomized to the', 'We enrolled and randomized all patients discharged home from a hospital general medicine service to a follow-up telephone call program or usual care discharge']","['telephone call program (n=1534) or usual care discharge', 'Follow-up Telephone Call Program']","['30-day readmissions or mortality', 'observation readmission, emergency department revisit, and mortality within 30 days, and patient experience ratings', 'emergency department revisits', 'hospital inpatient readmission', 'mortality', '30-day inpatient readmissions', 'observation readmissions', '30-Day Readmissions (FUTR-30']","[{'cui': 'C1304701', 'cui_str': 'Patient self-discharge against medical advice'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",3054.0,0.401488,We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.,"[{'ForeName': 'Maame Yaa A B', 'Initials': 'MYAB', 'LastName': 'Yiadom', 'Affiliation': 'Departments of Emergency Medicine.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Domenico', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hasselblad', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Neesha', 'Initials': 'N', 'LastName': 'Choma', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tucker-Marlow', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Monisha C', 'Initials': 'MC', 'LastName': 'Bhatia', 'Affiliation': 'School of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Johnston', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Tina V', 'Initials': 'TV', 'LastName': 'Hartert', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Departments of Emergency Medicine.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Medicine, Vanderbilt University.'}]",Medical care,['10.1097/MLR.0000000000001353']
1601,32731011,The effect of Hatha yoga intervention on students' creative ability.,"There is increasing demand for individual creativity as organizations seek innovative ways to remain relevant. Higher education institutions, particularly business schools, are sensitive to this demand and are constantly in search for innovative ways to enhance the creative ability of their students. Prior studies have shown encouraging results for physical activity-oriented interventions. Building on this research, this study uses Randomized Controlled Trial (RCT) to understand if an acute combinatory intervention, involving both physical and mental exercises embodied in Hatha yoga can improve individual creativity. This study uses 92 MBA student participants to investigate the impact of a 20-minute Hatha yoga session intervention against a short 20-minute case study session for the control group. Creative ability of the participants is operationalized through divergent and convergent thinking, which are then assessed through counter-balanced forms of Guilford Alternate Uses tasks and Remote Associate Test, respectively. The results show that while Hatha yoga significantly improves divergent thinking, the control group shows deterioration in divergent thinking. There is no effect on convergent thinking. These findings lend some support to the executive function hypothesis. The study also finds that prodding a person to be more creative on a routine academic task may not enhance their creative ability.",2020,There is no effect on convergent thinking.,"['92 MBA student participants', ""students' creative ability""]",['Hatha yoga intervention'],"['divergent thinking', 'individual creativity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",92.0,0.0286741,There is no effect on convergent thinking.,"[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bollimbala', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India; T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: ashish@tapmi.edu.in.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'James', 'Affiliation': 'IFIM Business School, Bangalore, Karnataka, India.'}, {'ForeName': 'Shirshendu', 'Initials': 'S', 'LastName': 'Ganguli', 'Affiliation': 'T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: shirshenduganguli@tapmi.edu.in.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103121']
1602,32731521,"Evaluation of a Cervical Stabilization Exercise Program for Pain, Disability, and Physical Impairments in University Violinists with Nonspecific Neck Pain.","Cervical stabilization exercises are frequently used to reduce pain, maximize function, and improve physical impairments for people with nonspecific neck pain. We conducted a single arm study to evaluate the effects of a home-based cervical stabilization exercise program for university violin players with nonspecific neck pain who frequently assume an asymmetrical neck posture and activate their superficial cervical flexors to stabilize the violin. Twenty violin players with nonspecific neck pain from university symphony orchestras participated in this study. All participants received assessments twice before the intervention and once immediately after a 6-week cervical stabilization exercise program. No significant differences were found between the two pretests before the intervention. After the intervention, the Numeric Rating Scale, the Neck Disability Index, the craniocervical flexion test, muscle endurance tests, cervical range of motion (all directions except flexion) tests, and cervicocephalic relocation tests (flexion and left rotation) showed improvements. The forward head posture indicated by the craniovertebral angle also slightly improved. The results of this single arm study suggest that cervical stabilization exercise is feasible and has the potential to improve physical health for collegiate violin players with nonspecific neck pain.",2020,"After the intervention, the Numeric Rating Scale, the Neck Disability Index, the craniocervical flexion test, muscle endurance tests, cervical range of motion (all directions except flexion) tests, and cervicocephalic relocation tests (flexion and left rotation) showed improvements.","['people with nonspecific neck pain', 'collegiate violin players with nonspecific neck pain', 'Twenty violin players with nonspecific neck pain from university symphony orchestras participated in this study', 'university violin players with nonspecific neck pain who frequently assume an asymmetrical neck posture and activate their superficial cervical flexors to stabilize the violin', 'University Violinists with Nonspecific Neck Pain']","['cervical stabilization exercise', 'Cervical Stabilization Exercise Program', 'home-based cervical stabilization exercise program', 'cervical stabilization exercise program', 'Cervical stabilization exercises']","['Numeric Rating Scale, the Neck Disability Index, the craniocervical flexion test, muscle endurance tests, cervical range of motion (all directions except flexion) tests, and cervicocephalic relocation tests (flexion and left rotation', 'Pain, Disability, and Physical Impairments']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231171', 'cui_str': 'Physical impairment'}]",,0.0369142,"After the intervention, the Numeric Rating Scale, the Neck Disability Index, the craniocervical flexion test, muscle endurance tests, cervical range of motion (all directions except flexion) tests, and cervicocephalic relocation tests (flexion and left rotation) showed improvements.","[{'ForeName': 'Yi-Liang', 'Initials': 'YL', 'LastName': 'Kuo', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70152, Taiwan.'}, {'ForeName': 'Tsung-Han', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70152, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70152, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17155430']
1603,32732022,"Effects of a leaflet on breast cancer screening knowledge, explicit attitudes, and implicit associations.","OBJECTIVE


To assess the effect of an information leaflet on knowledge, explicit attitudes, implicit associations, and attendance for breast cancer screening.
METHODS


Dutch women (aged 49-75 years) were approached three months before their breast cancer screening invitation. After providing informed consent, participants were randomised to receiving the information leaflet (intervention condition) or not (control condition). Screening knowledge, explicit attitudes, and implicit associations were assessed through web-based questionnaires, at baseline and two weeks later. Actual screening attendance data were collected.
RESULTS


In total, 988 women completed both questionnaires. Participants in the leaflet condition scored higher on knowledge (9.9 versus 9.6, p < 0.001, scale 0-11), and more often had positive explicit attitudes (97 % versus 95 %, p = 0.03), than those in the control condition. This contrast was bigger among first-time invitees. Implicit associations were not correlated with explicit attitudes or attendance. Explicit attitudes were moderately correlated with attendance (r=.30, p < 0.001).
CONCLUSION


The information leaflet led to more knowledge and more positive explicit attitudes. Implicit associations towards breast cancer screening were not correlated with attendance.
PRACTICE IMPLICATIONS


Encouragement to learn about the screening programme can increase levels of knowledge of invitees and therefore support their decision-making about participation. This might be especially relevant for first-time invitees.",2020,"Participants in the leaflet condition scored higher on knowledge (9.9 versus 9.6, p < 0.001, scale 0-11), and more often had positive explicit attitudes (97 % versus 95 %, p = 0.03), than those in the control condition.","['988 women completed both questionnaires', 'Dutch women (aged 49-75 years']",['information leaflet (intervention condition) or not (control condition'],"['Explicit attitudes', 'positive explicit attitudes', 'Implicit associations towards breast cancer screening', 'breast cancer screening knowledge, explicit attitudes, and implicit associations', 'knowledge']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",988.0,0.0280732,"Participants in the leaflet condition scored higher on knowledge (9.9 versus 9.6, p < 0.001, scale 0-11), and more often had positive explicit attitudes (97 % versus 95 %, p = 0.03), than those in the control condition.","[{'ForeName': 'Lindy M', 'Initials': 'LM', 'LastName': 'Kregting', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands. Electronic address: l.kregting@erasmusmc.nl.'}, {'ForeName': 'Nicolien T', 'Initials': 'NT', 'LastName': 'van Ravesteyn', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Wolfert', 'Initials': 'W', 'LastName': 'Spijker', 'Affiliation': 'Bevolkingsonderzoek Zuid-West, Rotterdam, the Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Dierks', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Clare A', 'Initials': 'CA', 'LastName': 'Aitken', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'H Amarens', 'Initials': 'HA', 'LastName': 'Geuzinge', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Ida J', 'Initials': 'IJ', 'LastName': 'Korfage', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}]",Patient education and counseling,['10.1016/j.pec.2020.06.032']
1604,32738408,Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.,"For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.",2020,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"['diverse patients attending HIV primary care clinics', 'Eligible and consenting patients from four HIV primary care clinical sites', 'people with HIV in health care', 'patients seen in HIV primary care']",['Positive Health Check intervention in addition to the standard of care or the standard of care only'],['HIV viral loads'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",4.0,0.0882936,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America. Electronic address: melewis@rti.org.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Harshbarger', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burrus', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Peinado', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Khavjou', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Karns', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Zulkiewicz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Galindo', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DallaPiazza', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Holm', 'Affiliation': 'NO AIDS Task Force dba CrescentCare, New Orleans, LA, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, Emory Vaccine Center, and Rollins School of Public Health, Atlanta, GA, United States of America; Atlanta VA Medical Center, Decatur, GA, United States of America.'}, {'ForeName': 'Charurut', 'Initials': 'C', 'LastName': 'Somboonwit', 'Affiliation': 'University of South Florida, Morsani College of Medicine, Tampa, FL, United States of America.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106097']
1605,32738416,"Afatinib in patients with advanced non-small cell lung cancer harboring HER2 mutations, previously treated with chemotherapy: A phase II trial.","BACKGROUND


Despite 1-4 % of NSCLC tumors harboring mutations in the HER2 gene, there are no approved HER2-pathway-targeted treatments available. We report an open-label, single-arm, multicenter phase II study investigating the efficacy and safety of afatinib in Asian patients with HER2-mutation positive (HER2m+) NSCLC.
METHODS


Eligible patients for Part A had confirmed stage IIIb/IV HER2m + NSCLC, had failed one or two prior lines of chemotherapy, and were EGFR/HER2-inhibitor naïve. Patients received oral afatinib 40 mg/day in continuous 28-day cycles, until disease progression or intolerable adverse events (AEs). Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2. In Part B, patients were to receive afatinib at the last received dose, plus paclitaxel 80 mg/m 2  weekly, until disease progression or intolerable AEs. The primary endpoint in Part A was objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS). Further exploratory endpoints were OR, DC, and PFS in Part B.
RESULTS


Eighteen patients received afatinib in Part A. No patient achieved an OR; 11 patients (61.1 %) achieved stable disease, and six patients (33.3 %) had progressive disease. DC rate was therefore 61.1 % (95 % confidence interval [CI]: 35.7, 82.7). A decrease in tumor size from baseline of > 0 to < 30 % was observed in eight patients. At the time of analysis, 16 patients (88.9 %) had progressed or died. Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08). All patients experienced ≥ 1 AE, most commonly diarrhea (66.7 %) and rash (33.3 %). No patients met the inclusion criteria for Part B, and recruitment was slow; therefore, the study was terminated.
CONCLUSIONS


This study found no clinical benefit of afatinib for EGFR TKI-naïve patients with HER2m + NSCLC.",2020,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","['Eighteen patients received afatinib in Part A', ""Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2"", 'EGFR TKI-naïve patients with HER2m\u202f+\u202fNSCLC', 'Asian patients with HER2-mutation positive (HER2m+) NSCLC', 'Eligible patients for Part A had confirmed stage IIIb/IV HER2m', 'patients with advanced non-small cell lung cancer harboring HER2 mutations']","['Afatinib', 'oral afatinib', 'plus paclitaxel 80\u202fmg/m 2  weekly, until disease progression or intolerable AEs', 'chemotherapy', 'afatinib']","['OR, DC, and PFS in Part B', 'diarrhea', 'DC rate', 'progressive disease', 'Median PFS', 'median OS', 'objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS', 'progressed or died', 'efficacy and safety', 'tumor size', 'stable disease', 'rash']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.160329,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'The First Affiliated Hospital with Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Hairui', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Dennis Chin-Lun', 'Initials': 'DC', 'LastName': 'Huang', 'Affiliation': 'Boehringer Ingelheim Taiwan Limited, Taipei, Taiwan.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China. Electronic address: caicunzhoudr@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.07.017']
1606,32738479,"Safety and immunogenicity of an alum-adjuvanted whole-virion H7N9 influenza vaccine: a randomized, blinded, clinical trial.","OBJECTIVES


A case of H7N9 influenza virus infection was first identified in China in 2013. This virus is considered to have high pandemic potential. Here we developed an H7N9 influenza vaccine containing an aluminium adjuvant and evaluated the safety and immunogenicity of the vaccine.
METHODS


From October 2017 through August 2018 we conducted a randomized, double-blinded, single-centre phase I clinical trial in China among 360 participants aged ≥12 years. All participants received two doses of the vaccine (7.5, 15 or 30 μg haemagglutinin antigen) or placebo at an interval of 21 days. Adverse event data were collected for 30 days after vaccination. Serum samples were collected on days 0, 21 and 42 for the haemagglutinin inhibition (HI) antibody assay.
RESULTS


A total of 347 participants (347/360, 96.4%) completed the study. The proportions of vaccine-related adverse events after one injection were 56.7% (34/60) in the 7.5-μg group, 86.7% (52/60) in the 15-μg group and 86.7% (52/60) in the 30-μg group. The proportions of adverse events after two injections were less than those reported after the first dose. None of the serious adverse events were related to the vaccine. After receiving two doses of the 7.5-μg vaccine, the proportion of participants achieving an HI titre of ≥40 was 98.2% (55/56, 95%CI 72.3~100.0%), with a geometric mean titre (GMT) of 192.6 (95%CI 162.9~227.8).
CONCLUSIONS


The alum-adjuvanted H7N9 whole-virion inactivated vaccine was safe and strongly immunogenic in a population aged ≥12 years.",2020,The alum-adjuvanted H7N9 whole-virion inactivated vaccine was safe and strongly immunogenic in a population aged 12 years and older.,"['population aged 12\xa0years and older', 'A total of 347 participants (347/360, 96.4%) completed the study', 'From October 2017 through August 2018', '360 participants aged 12\xa0years or older']","['placebo', 'vaccine', 'alum-adjuvanted whole-virion H7N9 influenza vaccine', 'H7N9 influenza vaccine containing an aluminium adjuvant']","['proportion of participants achieving an HI titer', 'Safety and immunogenicity']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319607', 'cui_str': '360'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C3665951', 'cui_str': 'Influenza due to Influenza A virus subtype H7N9'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",360.0,0.708817,The alum-adjuvanted H7N9 whole-virion inactivated vaccine was safe and strongly immunogenic in a population aged 12 years and older.,"[{'ForeName': 'Shilei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China; Key Laboratory of Medical Molecular Virology, School of Basic Medical Sciences, Shanghai Medical College of Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Province Centre for Disease Control and Prevention, Centre of Vaccine Clinical Research, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Province Centre for Disease Control and Prevention, Centre of Vaccine Clinical Research, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Yuelian', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'National Institutes for Food and Drug Control, WHO Collaborating Centre for Standardization and Evaluation of Biologicals, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Duan', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, 450001, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Province Centre for Disease Control and Prevention, Centre of Vaccine Clinical Research, China.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Key Laboratory of Medical Molecular Virology, School of Basic Medical Sciences, Shanghai Medical College of Fudan University, Shanghai, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Qu', 'Affiliation': 'Biosafety Level-3 Laboratory, Key Laboratory of Medical Molecular Virology MOE & MOH, School of Basic Medical Sciences, Fudan University, Shanghai, China.'}, {'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Biological Products, Shanghai, China. Electronic address: chenze2005@hotmail.com.'}, {'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Province Centre for Disease Control and Prevention, Centre of Vaccine Clinical Research, China. Electronic address: 1792865518@qq.com.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.07.033']
1607,32762708,Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial.,"BACKGROUND


Cervicothoracic (CT) junction hypomobility has been proposed as a contributing factor for neck pain. However, there are limited studies that compared the effect of CT junction mobilization against an effective intervention in neck pain. Thoracic spine manipulation is a nonspecific intervention for neck pain where remote spinal segments are treated based on the concept of regional interdependence. The effectiveness of segment-specific spinal mobilization in the cervical spine has been researched in the last few years, and no definite conclusions could be made from the previous studies. The above reasons warrant the investigation of the effects of a specific CT junction mobilization against a nonspecific thoracic manipulation intervention in neck pain. The present study aims to compare the immediate effects of C7-T1 Maitland mobilization with thoracic manipulation in individuals with mechanical neck pain presenting with CT junction dysfunction specifically.
METHODS


A randomized clinical trial is conducted where participants with complaints of mechanical neck pain and CT junction dysfunction randomly assigned to either C7-T1 level Maitland mobilization group or mid-thoracic (T3-T6) manipulation group (active control group). In both the groups, the post graduate student (SJ) pursuing Master's in orthopedic physiotherapy delivered the intervention. The outcomes of cervical flexion, extension, side flexion & rotation range of motion (ROM) were measured before & after the intervention with a cervical range of motion (CROM) device. Self-reported pain intensity was measured with the numerical pain rating scale (NPRS). The post-intervention between-group comparison was performed using a one-way ANCOVA test.
RESULTS


Forty-two participants with mean age CT junction group: 35.14 ± 10.13 and Thoracic manipulation group: 38.47 ± 11.47 were recruited for the study. No significant differences in the post-intervention baseline adjusted outcomes of cervical ROM & self-reported pain intensity were identified between the groups after the treatment (p = 0.08, 0.95, 0.01, 0.39, 0.29, 0.27for flexion, extension, bilateral lateral flexion & rotations respectively) & neck pain intensity (p = 0.68). However, within-group, pre, and post comparison showed significant improvements in cervical ROM and pain in both groups.
CONCLUSION


This preliminary study identified that CT junction mobilization is not superior to thoracic manipulation on the outcomes of cervical ROM and neck pain when level-specific CT junction mobilization was compared with remote mid-thoracic manipulation in individuals with mechanical neck pain and CT junction dysfunction.
TRIAL REGISTRATION


CTRI: 2018/04/013088, Registered 6 April 2018, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=24418.",2020,"No significant differences in the post-intervention baseline adjusted outcomes of cervical ROM & self-reported pain intensity were identified between the groups after the treatment (p = 0.08, 0.95, 0.01, 0.39, 0.29, 0.27for flexion, extension, bilateral lateral flexion & rotations respectively) & neck pain intensity (p = 0.68).","['participants with complaints of mechanical neck pain and CT junction dysfunction randomly assigned to either', 'individuals with mechanical neck pain presenting with CT junction dysfunction specifically', 'Forty-two participants with mean age CT junction group: 35.14\u2009±\u200910.13 and Thoracic manipulation group: 38.47\u2009±\u200911.47 were recruited for the study', 'mechanical neck pain with cervicothoracic junction dysfunction', 'individuals with mechanical neck pain and CT junction dysfunction', 'neck pain']","['cervicothoracic junction mobilization versus thoracic manipulation', 'CT junction mobilization', 'Thoracic spine manipulation', 'segment-specific spinal mobilization', 'C7-T1 level Maitland mobilization group or mid-thoracic (T3-T6) manipulation group (active control group', 'specific CT junction mobilization against a nonspecific thoracic manipulation intervention', 'C7-T1 Maitland mobilization with thoracic manipulation']","['cervical ROM & self-reported pain intensity', 'numerical pain rating scale (NPRS', 'range of motion and pain', 'cervical ROM and pain', 'neck pain intensity', 'Self-reported pain intensity', 'cervical flexion, extension, side flexion & rotation range of motion (ROM', 'cervical ROM and neck pain']","[{'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0450195', 'cui_str': 'Cervicothoracic'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0450195', 'cui_str': 'Cervicothoracic'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0446419', 'cui_str': 'Level of the first thoracic vertebra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",42.0,0.166055,"No significant differences in the post-intervention baseline adjusted outcomes of cervical ROM & self-reported pain intensity were identified between the groups after the treatment (p = 0.08, 0.95, 0.01, 0.39, 0.29, 0.27for flexion, extension, bilateral lateral flexion & rotations respectively) & neck pain intensity (p = 0.68).","[{'ForeName': 'Shriya', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Balthillaya', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Y V Raghava', 'Initials': 'YVR', 'LastName': 'Neelapala', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India. yuvaraghava999@gmail.com.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00327-4']
1608,32763585,Plasma MCP-1 levels in bipolar depression during cyclooxygenase-2 inhibitor combination treatment.,"BACKGROUND


Neuroinflammation plays a role in the pathophysiology of Bipolar Disorder Depression (BDD) and altered levels of inflammatory mediators, such as monocyte chemoattractant protein-1 (MCP-1, aka CCL2) have been reported. This study reports specifically on MCP-1 levels, as a potential marker of BDD and/or treatment response in patients receiving combination treatment with the cyclooxygenase-2 inhibitor, celecoxib (CBX).
METHODS


In this randomized, 10-week, double-blind, two-arm, placebo-controlled study, 47 patients with treatment resistant BDD received either escitalopram (ESC) + CBX, or ESC + placebo (PBO). Plasma MCP-1 levels were measured at 3 time points in the BDD subjects, and in a healthy control (HC) group. Depression severity was quantified using the Hamilton Depression Scale (HAMD-17).
RESULTS


The CBX group had significantly lower HAMD-17 scores vs. PBO at week 4 (P = 0.026) and week 8 (P = 0.002). MCP-1 levels were not significantly different in BDD vs. HC subjects at baseline (P = 0.588), nor in CBX vs. PBO groups at week 8 (P = 0.929). Week 8 HAMD-17 scores and MCP-1 levels were significantly negatively correlated in treatment non-responders to CBX or PBO (P = 0.050). Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014). MCP-1 was positively correlated with pro-inflammatory analytes in the PBO group and with anti-inflammatory analytes in the CBX group.
CONCLUSIONS


Combination treatment reduced treatment resistance and augmented antidepressant response. Baseline plasma MCP-1 levels were not altered in BDD patients. Since non-responders had lower levels of MCP-1, elevated MCP-1 may indicate a better response to CBX + SSRI treatment.",2020,Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014).,"['47 patients with treatment resistant BDD received either', 'patients receiving combination treatment with the']","['cyclooxygenase-2 inhibitor combination treatment', 'cyclooxygenase-2 inhibitor, celecoxib (CBX', 'CBX', 'escitalopram (ESC)\xa0+\xa0CBX, or ESC\xa0+\xa0placebo (PBO', 'placebo']","['Depression severity', 'Hamilton Depression Scale (HAMD-17', 'treatment resistance and augmented antidepressant response', 'MCP-1 levels', 'HAMD-17 scores and MCP-1 levels', 'MCP-1', 'Baseline plasma MCP-1 levels', 'Plasma MCP-1 levels', 'HAMD-17 scores vs. PBO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",47.0,0.0285352,Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edberg', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoppensteadt', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Walborn', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sinacore', 'Affiliation': 'Department of Public Health Sciences, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Halaris', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA. Electronic address: ahalaris@lumc.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.010']
1609,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2020,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
1610,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1611,32693197,"Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve.","Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.",2020,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","['patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft', 'subjects with atrial fibrillation or with venous thromboembolism', '1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3\u202fmonths prior', 'patients with a mechanical heart valve', 'patients with a mechanical On-X Aortic Heart Valve']","['PROACT Xa', 'apixaban 5\u202fmg twice daily or warfarin', 'apixaban versus warfarin', 'apixaban', 'warfarin', 'Vitamin K antagonists', 'apixaban with warfarin']","['efficacy and safety', 'composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding', 'hazard rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018829', 'cui_str': 'Prosthetic heart'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C3530472', 'cui_str': 'apixaban 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0697264,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","[{'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Department of Surgery, Duke University Medical Center, Durham, NC. Electronic address: oliver.jawitz@duke.edu.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Brittanny', 'Initials': 'B', 'LastName': 'Boyer', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Diseases, University of Cincinnati Heart, Lung & Vascular Institute, Cincinnati, OH.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Blackstone', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Department of Cardiovascular Surgery, Mount Sinai St. Luke's, New York, NY.""}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Gerdisch', 'Affiliation': 'Department of Cardiothoracic Surgery, Franciscan Hospital, Indianapolis, IN.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Johnston', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Capps', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Svensson', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}]",American heart journal,['10.1016/j.ahj.2020.06.014']
1612,32698033,The Role of Topical Antibiotic Prophylaxis in Oculofacial Plastic Surgery: A Randomized Controlled Study.,"PURPOSE


The usefulness of topical antibiotic prophylaxis for routine oculofacial plastic surgery is not well established. Given concerns such as contact dermatitis, antibiotic resistance, and healthcare costs in conjunction with a low baseline rate of surgical site infections, the investigators sought to determine the frequency of infection with and without the use of topical antibiotic prophylaxis.
DESIGN


Randomized, controlled, unmasked clinical trial.
PARTICIPANTS


Adult patients undergoing routine periocular surgery without prior history of periocular surgical site infection, need for perioperative oral or parenteral antibiotics, or allergy to all study medications.
METHODS


Participants were randomized before surgery to receive either antibiotic or placebo (mineral oil and petrolatum-based) ointment after surgery. Outcomes were measured at the first postoperative visit. The 2-tailed Fisher exact test was used to compare outcomes between groups.
MAIN OUTCOME MEASURES


The primary outcome was the incidence of surgical site infections. The secondary outcomes included stratification of infections by patient risk characteristics, incidence of allergic contact dermatitis, and incidence of wound complications.
RESULTS


Four hundred one participants were enrolled and randomized, and 13 participants did not proceed with surgery or were lost to follow-up. High-risk features for infection were identified in 24% of the placebo group and 21% of the antibiotic group. Surgical site infections were more common in the placebo group (2.7% vs. 0.0%; P = 0.025). The rate of contact dermatitis was similar (0.5% vs. 0.5%; P = 1.00), as was the rate of wound dehiscence (2.7% vs. 3.5%; P = 0.77). Among the placebo group, the incidence of infections in the low- and high-risk participants was 2.9% and 2.2%, respectively. Infections were treated with oral or topical antibiotics and resolved without complication, except in 1 patient who required 2 subsequent surgeries to address the sequelae.
CONCLUSIONS


After routine oculofacial plastic surgery, patients treated with a topical antibiotic ointment showed a lower risk of surgical site infection compared with patients treated with a nonantibiotic ointment.",2020,Surgical site infections were more common in the placebo group (2.7% vs. 0.0%; p=0.025).,"['Adult patients undergoing routine periocular surgery without prior history of periocular surgical site infection, need for perioperative oral or parenteral antibiotics, or allergy to all study medications', 'Participants', 'Four hundred and one participants were enrolled and randomized, and 13 participants did not proceed with surgery or were lost to follow-up', 'Oculofacial Plastic Surgery']","['topical antibiotic ointment', 'oral or topical antibiotics', 'antibiotic or placebo (mineral oil/petrolatum-based) ointment', 'Topical Antibiotic Prophylaxis', 'topical antibiotic prophylaxis', 'placebo']","['High-risk features for infection', 'rate of contact dermatitis', 'incidence of infections', 'stratification of infections by patient risk characteristics, incidence of allergic contact dermatitis, and incidence of wound complications', 'Surgical site infections', 'rate of wound dehiscence', 'risk of surgical site infection', 'incidence of surgical site infections']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1875504', 'cui_str': 'Mineral Oil / Petrolatum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011616', 'cui_str': 'Contact dermatitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0162820', 'cui_str': 'Allergic contact dermatitis'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}]",401.0,0.379817,Surgical site infections were more common in the placebo group (2.7% vs. 0.0%; p=0.025).,"[{'ForeName': 'Davin C', 'Initials': 'DC', 'LastName': 'Ashraf', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California. Electronic address: davin.ashraf@ucsf.edu.'}, {'ForeName': 'Oluwatobi O', 'Initials': 'OO', 'LastName': 'Idowu', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Qinyun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Tak', 'Initials': 'T', 'LastName': 'YeEun', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Copperman', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sombat', 'Initials': 'S', 'LastName': 'Tanaboonyawat', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, Phramongkutklao College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'M Reza', 'Initials': 'MR', 'LastName': 'Vagefi', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Kersten', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}]",Ophthalmology,['10.1016/j.ophtha.2020.07.032']
1613,32697957,"Effects of long-term concurrent training to failure or not in muscle power output, muscle quality and cardiometabolic risk factors in older men: A secondary analysis of a randomized clinical trial.","This study investigated the effects of concurrent training performed either with repetitions to failure or not to failure in muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat in older men. This is an ancillary analysis of a randomized controlled trial. 36 older men (mean age ± SD; 67.1 ± 5.1 years) were randomized into three groups: one performing repetitions to failure (RFG, n = 13), another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n = 12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n = 11). The training was performed twice a week for 20 weeks at intensities ranging from 65 to 80% of maximal strength. In each session, the individuals started with strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill. The primary endpoint was change from baseline to post-20 wk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak  through a maximal incremental test on a treadmill. All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001). In addition, all groups significantly decreased visceral fat thickness (ranging from -11 to -21%) (P < .001), and significantly increased VO 2peak  (ranging from 4 to 8%) (P < .01), with no differences between groups. No changes were observed in the MQ outcomes. Concurrent training performed using repetitions to failure or not to failure promoted similar gains in the muscle power output, aerobic capacity, and visceral fat in healthy older men.",2020,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"['36 older men (mean age\u202f±\u202fSD; 67.1\u202f±\u202f5.1\u202fyears', 'healthy older men', 'older men']","['another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n\u202f=\u202f12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n', 'strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill']","['VO 2peak', 'visceral fat thickness', 'MQ outcomes', 'muscle power output, muscle quality and cardiometabolic risk factors', 'change from baseline to post-20\u202fwk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak  through a maximal incremental test on a treadmill', 'jump height', 'muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",36.0,0.0273081,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"[{'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Teodoro', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Larissa X N', 'Initials': 'LXN', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Grazioli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina G', 'Initials': 'CG', 'LastName': 'Fritsch', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Radaelli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Saez de Asteasu', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil; Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'College of Physical Education, University of Brasilia, Brasília, DF, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Farinha', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ronei S', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: edu.cadore@ufrgs.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111023']
1614,32702335,"Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Studies have suggested that fluoxetine could improve neurological recovery after stroke. The Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke (EFFECTS) trial aimed to assess whether administration of oral fluoxetine for 6 months after acute stroke improves functional outcome.
METHODS


EFFECTS was an investigator-led, multicentre, randomised, placebo-controlled, double-blind, parallel group trial that enrolled patients aged 18 years or older between 2 and 15 days after stroke onset in 35 stroke and rehabilitation centres in Sweden. Eligible patients had a clinical diagnosis of ischaemic or intracerebral haemorrhage, brain imaging that was consistent with intracerebral haemorrhage or ischaemic stroke, and had at least one persisting focal neurological deficit. A web-based randomisation system that incorporated a minimisation algorithm was used to randomly assign (1:1) participants to receive oral fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Patients, care providers, investigators, and outcomes assessors were masked to the allocation. The primary outcome was functional status, measured with the modified Rankin Scale (mRS) at 6 months, analysed in all patients with available mRS data at the 6-month follow-up; we did an ordinal analysis adjusted for the minimisation variables used in the randomisation. This trial is registered with EudraCT, 2011-006130-16; ISRCTN, 13020412; and ClinicalTrials.gov, NCT02683213.
FINDINGS


Between Oct 20, 2014, and June 28, 2019, 1500 patients were enrolled, of whom 750 were randomly assigned to fluoxetine and 750 were randomly assigned to placebo. At 6 months, mRS data were available for 737 (98%) patients in the fluoxetine group and 742 (99%) patients in the placebo group. There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42). The proportion of patients with a new diagnosis of depression was lower with fluoxetine than with placebo (54 [7%] patients vs 81 [11%] patients; difference -3·60% [-6·49 to -0·71]; p=0·015), but fluoxetine was associated with more bone fractures (28 [4%] vs 11 [2%]; difference 2·27% [0·66 to 3·87]; p=0·0058) and hyponatraemia (11 [1%] vs one [<1%]; difference 1·33% [0·43 to 2·23]; p=0·0038) at 6 months.
INTERPRETATION


Functional outcome after acute stroke did not improve with oral fluoxetine 20 mg once daily for 6 months. Fluoxetine reduced the occurrence of depression but increased the risk of bone fractures and hyponatraemia. Our results do not support the use of fluoxetine after acute stroke.
FUNDING


The Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Brain Foundation, the Swedish Society of Medicine, King Gustav V and Queen Victoria's Foundation of Freemasons, and the Swedish Stroke Association (STROKE-Riksförbundet).",2020,There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42).,"['enrolled patients aged 18 years or older between 2 and 15 days after stroke onset in 35 stroke and rehabilitation centres in Sweden', 'Eligible patients had a clinical diagnosis of ischaemic or intracerebral haemorrhage, brain imaging that was consistent with intracerebral haemorrhage or ischaemic stroke, and had at least one persisting focal neurological deficit', '1500 patients were enrolled, of whom 750 were randomly assigned to', 'Between Oct 20, 2014, and June 28, 2019']","['oral fluoxetine', 'fluoxetine', 'oral fluoxetine 20 mg once daily or matching placebo', 'Fluoxetine', 'placebo']","['occurrence of depression', 'functional outcome', 'bone fractures', 'risk of bone fractures and hyponatraemia', 'Safety and efficacy', 'proportion of patients with a new diagnosis of depression', 'functional status, measured with the modified Rankin Scale (mRS', 'neurological recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",1500.0,0.629145,There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42).,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30219-2']
1615,32702334,"Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population.
METHODS


AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2-15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921.
FINDINGS


Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76-1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months.
INTERPRETATION


Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke.
FUNDING


National Health and Medical Research Council of Australia.",2020,"Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures.","['43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten', 'ethnically diverse population', 'Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2-15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more', '1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706', 'after acute stroke (AFFINITY', 'Between Jan 11, 2013, and June 30, 2019']","['FluoxetINe', 'fluoxetine', 'fluoxetine 20 mg capsules or matching placebo', 'Oral fluoxetine', 'placebo']","['functional outcome', 'distribution of mRS categories', 'bone fractures', 'falls', 'Safety and efficacy', 'epileptic seizures', 'risk of falls, bone fractures, and epileptic seizures', 'mRS data']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1280.0,0.655404,"Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30207-6']
1616,32702169,Randomised clinical trial: significant biochemical and colonic transit effects of the farnesoid X receptor agonist tropifexor in patients with primary bile acid diarrhoea.,"BACKGROUND


In primary bile acid diarrhoea, feedback by farnesoid X receptor (FXR) and fibroblast growth hormone 19 (FGF19) on hepatic bile acid production is impaired.
AIMS


To evaluate the safety, mechanisms and efficacy of negative feedback by FXR activation with tropifexor, a non-bile acid FXR agonist, in patients with primary bile acid diarrhoea.
METHODS


In this double-blind, multicentre, randomised, cross-over study, patients received tropifexor 60 µg or placebo once daily for 14 days in each of two treatment periods. Primary objectives included tropifexor safety and tolerability, and on stool frequency and form. Other assessments included pharmacokinetic and pharmacodynamic measures, biochemical markers and gastrointestinal transit.
RESULTS


Twenty patients (tropifexor 60 µg/placebo [N = 10]; placebo/tropifexor 60 µg [N = 10]) were enrolled. Adverse event rates were lower with tropifexor vs placebo (52.9% vs 73.7%). No patient had pruritus during tropifexor intake. There were no significant differences in stool frequency, stool form or loperamide use between treatments. Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels for up to 8 h. Plasma tropifexor concentrations peaked at 5 hours post-dose on days 1 and 12. At day 12, tropifexor caused reduction in peak total bile acid concentration (33%, P = 0.032) and exposure (36%, P = 0.005). Moreover, tropifexor showed a significant increase in ascending colon half-emptying time (P = 0.036).
CONCLUSIONS


Tropifexor 60 µg once daily had acceptable safety and tolerability. Changes in FGF19 and C4 showed effective target engagement; however, higher doses may be required to observe stool frequency changes. Slowing of ascending colon emptying suggests therapeutic potential of tropifexor in patients with primary bile acid diarrhoea. ClinicalTrials.gov number: NCT02713243.",2020,Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels for up to 8 h. Plasma tropifexor concentrations peaked at 5 hours post-dose on days 1 and 12.,"['60\xa0µg [N\xa0=\xa010]) were enrolled', 'patients with primary bile acid diarrhoea', 'Twenty patients (tropifexor 60\xa0µg']","['placebo/tropifexor', 'placebo', 'tropifexor 60\xa0µg or placebo', 'farnesoid X receptor agonist tropifexor', 'tropifexor vs placebo']","['stool frequency, stool form or loperamide use', 'tropifexor safety and tolerability, and on stool frequency and form', 'acceptable safety and tolerability', 'Plasma tropifexor concentrations', 'peak total bile acid concentration', 'Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels', 'Adverse event rates', 'pharmacokinetic and pharmacodynamic measures, biochemical markers and gastrointestinal transit', 'ascending colon half-emptying time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4524087', 'cui_str': 'Bile acid diarrhea'}, {'cui': 'C4726919', 'cui_str': 'tropifexor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4726919', 'cui_str': 'tropifexor'}, {'cui': 'C4521707', 'cui_str': 'Farnesoid X receptor agonist'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4726919', 'cui_str': 'tropifexor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0201914', 'cui_str': 'Total bile acids measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0055520', 'cui_str': 'cholest-4-en-3-one'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0017191', 'cui_str': 'Gastrointestinal transit study'}, {'cui': 'C0227375', 'cui_str': 'Ascending colon structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.357184,Tropifexor increased FGF19 and decreased 7α-hydroxy-4-cholesten-3-one (C4) levels for up to 8 h. Plasma tropifexor concentrations peaked at 5 hours post-dose on days 1 and 12.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Sara Linker', 'Initials': 'SL', 'LastName': 'Nord', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ibironke', 'Initials': 'I', 'LastName': 'Oduyebo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Koeun', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Prafulla', 'Initials': 'P', 'LastName': 'Bhad', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Badman', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Sanders', 'Affiliation': 'The Academic Unit of Gastroenterology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Julian R F', 'Initials': 'JRF', 'LastName': 'Walters', 'Affiliation': 'Division of Digestive Diseases, Imperial College London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15967']
1617,32708637,Virtual Reality Aggression Prevention Therapy (VRAPT) versus Waiting List Control for Forensic Psychiatric Inpatients: A Multicenter Randomized Controlled Trial.,"Many forensic psychiatric inpatients have difficulties regulating aggressive behavior. Evidence of effective aggression treatments is limited. We designed and investigated the effectiveness of a transdiagnostic application of a virtual reality aggression prevention training (VRAPT). In this randomized controlled trial at four Dutch forensic psychiatric centers, 128 inpatients with aggressive behavior were randomly assigned to VRAPT ( N  = 64) or waiting list control group ( N  = 64). VRAPT consisted of 16 one-hour individual treatment sessions twice a week. Assessments were done at baseline, post-treatment and at 3-month follow-up. Primary outcome measures were aggressive behavior observed by staff and self-reported aggressive behavior. Analysis was by intention to treat. This trial was registered in the Dutch Trial Register (NTR, TC = 6340). Participants were included between 1 March 2017, and 31 December 2018. Compared to waiting list, VRAPT did not significantly decrease in self-reported or observed aggressive behavior (primary outcomes). Hostility, anger control, and non-planning impulsiveness improved significantly in the VRAPT group compared to the control group at post-treatment. Improvements were not maintained at 3-month follow-up. Results suggest that VRAPT does not decrease aggressive behavior in forensic inpatients. However, there are indications that VRAPT temporarily influences anger control skills, impulsivity and hostility.",2020,"Hostility, anger control, and non-planning impulsiveness improved significantly in the VRAPT group compared to the control group at post-treatment.","['forensic inpatients', 'Participants were included between 1 March 2017, and 31 December 2018', 'Forensic Psychiatric Inpatients', 'four Dutch forensic psychiatric centers, 128 inpatients with aggressive behavior']","['virtual reality aggression prevention training (VRAPT', 'waiting list control', 'Virtual Reality Aggression Prevention Therapy (VRAPT', 'VRAPT']","['anger control skills, impulsivity and hostility', 'Hostility, anger control, and non-planning impulsiveness', 'aggressive behavior', 'aggressive behavior observed by staff and self-reported aggressive behavior']","[{'cui': 'C0016557', 'cui_str': 'Medicine, Forensic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",128.0,0.149137,"Hostility, anger control, and non-planning impulsiveness improved significantly in the VRAPT group compared to the control group at post-treatment.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Klein Tuente', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Developmental Psychology, Tilburg University, Prof Cobbenhagenlaan 225, P.O. Box 90153, 5000 LE Tilburg, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bulten', 'Affiliation': 'Division Diagnostics Research and Education, Forensic Psychiatric Hospital Pompefoundation, Weg door Jonkerbos 55, 6532 CN Nijmegen, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Keulen-de Vos', 'Affiliation': 'Forensic Psychiatric Center (FPC) de Rooyse Wissel, P.O. Box 433, 5800AK Venray, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Vos', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Bokern', 'Affiliation': 'Forensic Psychiatric Center (FPC) Dr. S. van Mesdag, Helperlinie 2, 9722 AZ Groningen, The Netherlands.'}, {'ForeName': 'Sarah van', 'Initials': 'SV', 'LastName': 'IJzendoorn', 'Affiliation': 'Fivoor, Fivoor Science & Treatment Innovation, Kijvelandsekade 1, 3172 AB Poortugaal, The Netherlands.'}, {'ForeName': 'Chris N W', 'Initials': 'CNW', 'LastName': 'Geraets', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Veling', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9072258']
1618,32708657,Changes in Circulating Extracellular Vesicles in Patients with ST-Elevation Myocardial Infarction and Potential Effects of Remote Ischemic Conditioning-A Randomized Controlled Trial.,"(1) Background: Extracellular vesicles (EVs) have been recognized as a cellular communication tool with cardioprotective properties; however, it is unknown whether cardioprotection by remote ischemic conditioning (RIC) involves EVs. (2) Methods: We randomized patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) to additionally receive a protocol of RIC or a sham-intervention. Blood was taken before and immediately, 24 h, four days and one month after PCI. Additionally, we investigated EVs from healthy volunteers undergoing RIC. EVs were characterized by a high-sensitive flow cytometer (Beckman Coulter Cytoflex S, Krefeld, Germany). (3) Results: We analyzed 32 patients (16 RIC, 16 control) and five healthy volunteers. We investigated platelet-, endothelial-, leukocyte-, monocyte- and granulocyte-derived EVs and their pro-thrombotic sub-populations expressing superficial phosphatidylserine (PS + ). We did not observe a significant effect of RIC on the numbers of circulating EVs, although granulocyte-derived EVs were significantly higher in the RIC group. In line, RIC had not impact on EVs in healthy volunteers. Additionally, we observed changes of PS + /PEV, EEVs and PS + /CD15 +  EVs irrespective of RIC with time following STEMI. 4) Conclusion: We provide further insights into the course of different circulating EVs during the acute and sub-acute phases of STEMI. With respect to the investigated EV populations, RIC seems to have no effect, with only minor differences found for granulocyte EVs.",2020,"With respect to the investigated EV populations, RIC seems to have no effect, with only minor differences found for granulocyte EVs.","['patients with ST-elevation myocardial infarction (STEMI) undergoing primary', 'healthy volunteers', 'Patients with ST-Elevation Myocardial Infarction', '32 patients (16 RIC, 16 control) and five healthy volunteers', 'healthy volunteers undergoing RIC']","['platelet-, endothelial-, leukocyte-, monocyte- and granulocyte-derived EVs and their pro-thrombotic sub-populations expressing superficial phosphatidylserine (PS + ', 'percutaneous coronary intervention (PCI) to additionally receive a protocol of RIC or a sham-intervention']","['PS + /PEV, EEVs and PS + /CD15 +  EVs irrespective of RIC', 'numbers of circulating EVs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0031623', 'cui_str': 'Phosphatidylserine'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",32.0,0.0477398,"With respect to the investigated EV populations, RIC seems to have no effect, with only minor differences found for granulocyte EVs.","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Haller', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, 1160 Vienna, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Jäger', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, 1160 Vienna, Austria.'}, {'ForeName': 'Edita', 'Initials': 'E', 'LastName': 'Piackova', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, 1160 Vienna, Austria.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Sztulman', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, 1160 Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Wegberger', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, 1160 Vienna, Austria.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Wojta', 'Affiliation': 'Ludwig Boltzmann Institute for Cardiovascular Research, 1160 Vienna, Austria.'}, {'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Gyöngyösi', 'Affiliation': 'Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Ludwig Boltzmann Institute for Cardiovascular Research, 1160 Vienna, Austria.'}, {'ForeName': 'Bruno K', 'Initials': 'BK', 'LastName': 'Podesser', 'Affiliation': 'Ludwig Boltzmann Institute for Cardiovascular Research, 1160 Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Spittler', 'Affiliation': 'Core Facility, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, 1160 Vienna, Austria.'}]",Biomedicines,['10.3390/biomedicines8070218']
1619,32708705,Metabolites as Prognostic Markers for Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients Treated with First-Line Platinum-Doublet Chemotherapy.,"The metabolic requirements of metastatic non-small cell lung (mNSCLC) tumors from patients receiving first-line platinum-doublet chemotherapy are hypothesized to imprint a blood signature suitable for survival prediction. Pre-treatment samples prospectively collected at baseline from a randomized phase III trial were assayed using nuclear magnetic resonance (NMR) spectroscopy ( n  = 341) and ultra-high performance liquid chromatography - mass spectrometry (UPLC-MS) ( n  = 297). Distributions of time to event outcomes were estimated by Kaplan-Meier analysis, and baseline characteristics adjusted Cox regression modeling was used to correlate markers' levels to time to event outcomes. Sixteen polar metabolites were significantly correlated with overall survival (OS) by univariate analysis ( p  < 0.025). Formate, 2-hydroxybutyrate, glycine and  myo -inositol were selected for a multivariate model. The median OS was 6.6 months in the high-risk group compared to 11.4 months in the low risk group HR (Hazard Ratio) = 1.99, 95% C.I. (Confidence Interval) 1.45-2.68;  p  < 0.0001). Modeling of lipids by class (sphingolipids, acylcarnitines and lysophosphatidylcholines) revealed a median OS = 5.7 months vs. 11. 9 months for the high vs. low risk group. (HR: 2.23, 95% C.I. 1.55-3.20;  p  < 0.0001). These results demonstrate that metabolic profiles from pre-treatment samples may be useful to stratify clinical outcomes for mNSCLC patients receiving chemotherapy. Genomic and longitudinal measurements pre- and post-treatment may yield addition information to personalize treatment decisions further.",2020,Sixteen polar metabolites were significantly correlated with overall survival (OS) by univariate analysis ( p  < 0.025).,"['Metastatic Non-Small Cell Lung Cancer', 'metastatic non-small cell lung (mNSCLC) tumors from patients receiving first-line platinum-doublet chemotherapy', 'mNSCLC patients receiving chemotherapy']","['nuclear magnetic resonance (NMR) spectroscopy ( n  = 341) and ultra-high performance liquid chromatography - mass spectrometry (UPLC-MS', 'First-Line Platinum-Doublet Chemotherapy']","['median OS', 'overall survival (OS']","[{'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0024121', 'cui_str': 'Neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}, {'cui': 'C0008562', 'cui_str': 'High pressure liquid chromatography'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0689696,Sixteen polar metabolites were significantly correlated with overall survival (OS) by univariate analysis ( p  < 0.025).,"[{'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Hao', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Centre and Cummings School of Medicine, University of Calgary, 1331-29th Street N.W., Calgary, AB T2N 4N2, Canada.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia PA 19104, USA.'}, {'ForeName': 'Keyue', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Ubeydullah', 'Affiliation': 'Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia PA 19104, USA.'}, {'ForeName': 'Saikumari', 'Initials': 'S', 'LastName': 'Krishnaiah', 'Affiliation': 'Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia PA 19104, USA.'}, {'ForeName': 'Natasha B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, 700 University Avenue, Toronto, ON M5G 1Z5, Canada.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, 700 University Avenue, Toronto, ON M5G 1Z5, Canada.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Seymour', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Aalim', 'Initials': 'A', 'LastName': 'Weljie', 'Affiliation': 'Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia PA 19104, USA.'}]",Cancers,['10.3390/cancers12071926']
1620,32707332,An invited commentary: The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,,2020,,['renal transplantation'],['transversus abdominis plane block with or without dexmedetomidine'],[],"[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.168804,,"[{'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: yulang5301@sina.com.'}, {'ForeName': 'Taowu', 'Initials': 'T', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: chenmingaini1232@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.008']
1621,32712103,Progression of Fatty Liver Disease in Children Receiving Standard of Care Lifestyle Advice.,"BACKGROUND & AIMS


Nonalcoholic fatty liver disease (NAFLD) is the most common pediatric chronic liver disease. Little is known about outcomes in recognized youth.
METHODS


We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13±3 years; age range, 8-17 years) who received placebo and standard of care lifestyle advice in 2 double-blind, randomized clinical trials within the nonalcoholic steatohepatitis (NASH) clinical research network from 2005 through 2015. We analyzed histologic changes with respect to baseline and longitudinal change in clinical variables using regression analysis.
RESULTS


At enrollment, 31% of the children had definite NASH, 34% had borderline zone 1 NASH, 13% had borderline zone 3 NASH, and 21% had fatty liver but not NASH. Over a mean time period of 1.6±0.4 years, borderline or definite NASH resolved in 29% of the children, whereas 18% of the children with fatty liver or borderline NASH developed definite NASH. Fibrosis improved in 34% of the children but worsened in 23%. Any progression to definite NASH or in fibrosis occurred in 36% of the children, and both occurred in 11% of the children. Any improvement in NASH or fibrosis occurred in 52%, and both occurred in 20% of children. Type 2 diabetes developed in 5% of the cohort. Any progression to NASH and/or fibrosis were associated with adolescent age, higher waist circumference, levels of alanine or aspartate aminotransferase, total and low density lipoprotein cholesterol at baseline, increasing level of alanine aminotransferase, hemoglobin A1C (P<.05). Progression to NASH and/or fibrosis were also associated with increasing level of gamma-glutamyl transferase and development of type 2 diabetes (P<.01). Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003).
CONCLUSIONS


One-third of children with NAFLD enrolled in placebo groups of clinical trials had histologic features of progression within 2 years, in association with increasing obesity and serum levels of aminotransferases and loss of glucose homeostasis.",2020,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003).
","['We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13±3 years; age range, 8-17 years) who received', 'Children Receiving Standard of Care Lifestyle Advice']","['placebo and standard of care lifestyle advice', 'placebo', 'NASH']","['Increasing level of gamma-glutamyl transferase', 'Fibrosis', 'borderline or definite NASH', 'level of gamma-glutamyl transferase and development of type 2 diabetes', 'obesity and serum levels of aminotransferases and loss of glucose homeostasis', 'NASH or fibrosis', 'waist circumference, levels of alanine or aspartate aminotransferase, total and low density lipoprotein cholesterol at baseline, increasing level of alanine aminotransferase, hemoglobin A1C (P<.05']","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",139.0,0.180644,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003).
","[{'ForeName': 'Stavra A', 'Initials': 'SA', 'LastName': 'Xanthakos', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia Vagelos College of Physicians and Surgeons, New York, New York. Electronic address: jl3553@columbia.edu.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Molleston', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Indiana University School of Medicine/Riley Hospital for Children, Indianapolis, Indiana.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosenthal', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, Benioff Children's Hospital, San Francisco, California.""}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Murray', 'Affiliation': ""Pediatrics Institute, Cleveland Clinic Children's, Cleveland, Ohio.""}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, St. Louis University, St. Louis, Missouri.'}, {'ForeName': 'Ann O', 'Initials': 'AO', 'LastName': 'Scheimann', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tamir', 'Initials': 'T', 'LastName': 'Miloh', 'Affiliation': 'Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fishbein', 'Affiliation': 'Department of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'Department of Pathology, Sharp Memorial Hospital; Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Diego, CA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Brunt', 'Affiliation': 'Department of Pathology and Immunology, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.034']
1622,32717846,"The Sustainability and Scalability of Private Sector Sanitation Delivery in Urban Informal Settlement Schools: A Mixed Methods Follow Up of a Randomized Trial in Nairobi, Kenya.","There are considerable challenges to achieving the Sustainable Development Goals' target of universal access to basic sanitation in schools. Schools require safe, clean, and sex-segregated facilities for a large number of students. Robust and affordable solutions are needed to address the economic, spatial, social, institutional, and political factors which contribute to poor sanitary conditions in informal settlements. In 2015, we undertook a randomized controlled trial to assess the feasibility of private sector sanitation delivery (PSSD) in 20 primary schools, in informal settlements of Nairobi, Kenya. Our preliminary evaluation after one year of service delivery suggested that PSSD of urine-diverting dry latrines with routine waste collection and maintenance provided a feasible, lower-cost alternative to the government standard delivery (GSD) of cistern-flush toilets or ventilated improved pit latrines. We conducted a mixed-methods follow-up study to assess sanitation delivery over 3-4 years and investigate prevailing drivers and barriers that may influence the scalability of PSSD. The conditions of newly constructed and rehabilitated GSD facilities diminished quickly, reverting to the conditions of existing facilities, indicating lower sustainability compared to sanitation delivered from the private sector. Barriers in financial aspects related to the ongoing implementation of PSSD emerged, particularly among public schools, and few were able to pay for continued service. Our study demonstrates that the engagement of the private sector may lead to improvements in affordable, safely managed sanitation for schools and their students. Yet, to reach a sustained scale, additional guidance is needed on how to develop these partnerships, streamline procurement and contracting processes, and incorporate appropriate financing mechanisms.",2020,"Our study demonstrates that the engagement of the private sector may lead to improvements in affordable, safely managed sanitation for schools and their students.","['Urban Informal Settlement Schools', '20 primary schools, in informal settlements of Nairobi, Kenya']",['private sector sanitation delivery (PSSD'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0033176', 'cui_str': 'Private Sector'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],,0.0218354,"Our study demonstrates that the engagement of the private sector may lead to improvements in affordable, safely managed sanitation for schools and their students.","[{'ForeName': 'Jedidiah S', 'Initials': 'JS', 'LastName': 'Snyder', 'Affiliation': 'Gangarosa Department of Environmental Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Prentice-Mott', 'Affiliation': 'Gangarosa Department of Environmental Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Boera', 'Affiliation': 'Consultant, Nairobi 00100, Kenya.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mwaki', 'Affiliation': 'Safe Water & AIDS Project, Kisumu 40100, Kenya.'}, {'ForeName': 'Kelly T', 'Initials': 'KT', 'LastName': 'Alexander', 'Affiliation': 'CARE, Atlanta, GA 30307, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Freeman', 'Affiliation': 'Gangarosa Department of Environmental Health, Emory University, Atlanta, GA 30322, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17155298']
1623,32717868,Assessment of Attitudes Toward Physical Education by the Implementation of an Extracurricular Program for Obese Children.,"The World Health Organization (WHO) identifies the importance of implementing physical activity programs such as physical education (PE) classes in schools. This study identifies the attitudes of obese children toward PE, before and after participation in a vigorous-intensity physical exercise program without the participation of normal-weight peers using a questionnaire on Attitudes toward Physical Education (CAEF). 98 children between 8-11 years of age were randomized in an Experimental Group (GE) ( n  = 48) and a Control Group (CG) ( n  = 47). They were assessed using a questionnaire on Attitudes toward Physical Education (CAEF). All the study participants exhibited a BMI Z-score ≥ 2. Before the intervention, the only difference between boys and girls was ""empathy to teacher and physical education subject"" ( p  = 0.001, d de Cohen = 0.72, r = 0.34). The interaction between gender and training was only present in empathy for the teacher, with a medium effect size ( η 2  = 0.055). The implementation of PE with two hours per week elicits only a few effects over the attitude of obese children, even though with a certain engagement of gender through training in the adjustment of empathy for teachers and the PE class.",2020,"Before the intervention, the only difference between boys and girls was ""empathy to teacher and physical education subject"" ( p  = 0.001, d de Cohen =","['Obese Children', '98 children between 8-11 years of age']","['vigorous-intensity physical exercise program', 'Control Group (CG']","['Attitudes toward Physical Education (CAEF', 'empathy to teacher and physical education subject']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",98.0,0.017797,"Before the intervention, the only difference between boys and girls was ""empathy to teacher and physical education subject"" ( p  = 0.001, d de Cohen =","[{'ForeName': 'Ena Monserrat', 'Initials': 'EM', 'LastName': 'Romero-Pérez', 'Affiliation': 'Division of Biological Sciences and Health, University of Sonora, 83000 Hermosillo, Sonora, Mexico.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Núñez Enríquez', 'Affiliation': 'Faculty of Physical Culture Sciences, Autonomous University of Chihuahua, 31000 Chihuahua, Chih, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gastélum-Cuadras', 'Affiliation': 'Faculty of Physical Culture Sciences, Autonomous University of Chihuahua, 31000 Chihuahua, Chih, Mexico.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Horta-Gim', 'Affiliation': 'Division of Biological Sciences and Health, University of Sonora, 83000 Hermosillo, Sonora, Mexico.'}, {'ForeName': 'Jerónimo J', 'Initials': 'JJ', 'LastName': 'González-Bernal', 'Affiliation': 'Department of Health Sciences, University of Burgos, 09001 Burgos, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'de Paz', 'Affiliation': 'Division of Biological Sciences and Health, University of Sonora, 83000 Hermosillo, Sonora, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17155300']
1624,32717926,The Effects of Alcohol Consumption on Cardiometabolic Health Outcomes Following Weight Loss in Premenopausal Women with Obesity: A Pilot Randomized Controlled Trial.,"Alcohol (i.e., ethanol) is consumed regularly by much of the adult population; yet, the health effects associated with its use are not well-characterized. Clinical interventions to investigate the effects of moderate alcohol consumption on metabolic outcomes, including adiposity and cardiovascular risk factors, are limited and have yielded conflicting data. In addition, no study has reported the effects of routine alcohol intake during weight loss in a controlled feeding trial. We present the first randomized controlled pilot trial to investigate the effects of moderate alcohol consumption on metabolic outcomes during weight loss in women with obesity. Both groups consumed 30% energy restricted diets and were randomized to either an ethanol-free control (CTL) group or a group (EtOH) that consumed 35 g ethanol daily for eight weeks. Our findings demonstrate that, despite similar weight loss, the decrease in mean arterial pressure was attenuated in the EtOH group, relative to the CTL group ( p  = 0.02). In addition, decreases in other outcomes, including visceral adipose tissue ( p  = 0.23), circulating lipids (triglycerides ( p  = 0.11) and cholesterol ( p  = 0.11)), and uric acid ( p  = 0.07) tended to be attenuated with alcohol consumption. These pilot data provide potential evidence that moderate alcohol consumption may mitigate the beneficial effects of weight loss and support the need for larger Randomized Controlled Trials (RCTs) to better investigate the metabolic effects of moderate alcohol intake in humans.",2020,"In addition, decreases in other outcomes, including visceral adipose tissue ( p  = 0.23), circulating lipids (triglycerides ( p  = 0.11) and cholesterol ( p  = 0.11)), and uric acid ( p  = 0.07) tended to be attenuated with alcohol consumption.","['Premenopausal Women with Obesity', 'women with obesity']","['ethanol-free control (CTL', 'moderate alcohol consumption', 'Alcohol Consumption', 'Alcohol (i.e., ethanol']","['visceral adipose tissue', 'circulating lipids (triglycerides', 'Cardiometabolic Health Outcomes', 'uric acid', 'mean arterial pressure', 'weight loss', 'adiposity and cardiovascular risk factors']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0546005,"In addition, decreases in other outcomes, including visceral adipose tissue ( p  = 0.23), circulating lipids (triglycerides ( p  = 0.11) and cholesterol ( p  = 0.11)), and uric acid ( p  = 0.07) tended to be attenuated with alcohol consumption.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'White', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17155302']
1625,32721578,The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods.,"BACKGROUND


Data addressing air quality effects on children with asthma in rural U.S. communities are rare. Our community engaged research partnership previously demonstrated associations between neighborhood NH 3  and ambient PM 2.5  and asthma in the agricultural lower Yakima Valley of Washington. As a next step, the partnership desired an intervention approach to address concerns about pediatric asthma in this largely Latino immigrant, farm worker community.
OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  We investigated the effect of this enriched approach on these exposures and asthma health measures.
DESIGN


We randomized children with poorly controlled asthma to a control arm (current asthma education program) or an intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home). Outcomes included (1) 14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics at baseline, midpoint (4-6 months) and one-year follow-up. These included the Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration.
DISCUSSION


To our knowledge, this is the first randomized HEPA cleaner intervention designed to assess NH 3  as well as PM 2.5  and to evaluate health outcomes of children with asthma in an agricultural region.",2020,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","['children with asthma in rural U.S. communities', 'children with asthma in an agricultural region', 'children with poorly controlled asthma to a control arm (current asthma education program) or an']","[""intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home""]","['14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics', 'Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337099', 'cui_str': 'Air contaminant'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4704932', 'cui_str': 'Health Metrics'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0221442,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Masterson', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America. Electronic address: emaster@uw.edu.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Younglove', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': ""Yakima Valley Farm Worker's Clinic, Toppenish, WA, United States of America.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Torres', 'Affiliation': 'Northwest Communities Education Center, Radio KDNA, Granger, WA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Krenz', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tchong French', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Riederer', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sampson', 'Affiliation': 'Department of Statistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Nervana', 'Initials': 'N', 'LastName': 'Metwali', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Min', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Aisenberg', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Babadi', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Farquhar', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Health Services, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Karr', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Pediatrics, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106085']
1626,32721655,Do ethics classes influence student behavior? Case study: Teaching the ethics of eating meat.,"Do university ethics classes influence students' real-world moral choices? We aimed to conduct the first controlled study of the effects of ordinary philosophical ethics classes on real-world moral choices, using non-self-report, non-laboratory behavior as the dependent measure. We assigned 1332 students in four large philosophy classes to either an experimental group on the ethics of eating meat or a control group on the ethics of charitable giving. Students in each group read a philosophy article on their assigned topic and optionally viewed a related video, then met with teaching assistants for 50-minute group discussion sections. They expressed their opinions about meat ethics and charitable giving in a follow-up questionnaire (1032 respondents after exclusions). We obtained 13,642 food purchase receipts from campus restaurants for 495 of the students, before and after the intervention. Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after). Ethical opinion also differed, with 43% of students in the experimental group agreeing that eating the meat of factory farmed animals is unethical compared to 29% in the control group. We also attempted to measure food choice using vouchers, but voucher redemption rates were low and no effect was statistically detectable. It remains unclear what aspect of instruction influenced behavior.",2020,"Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after).",['1332 students in four large philosophy classes to either an experimental group on the ethics of eating meat or a control group on the ethics of charitable giving'],['ordinary philosophical ethics classes'],['Purchase of meat products'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0031534', 'cui_str': 'Philosophy'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0025018', 'cui_str': 'Meat products'}]",1332.0,0.0290026,"Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Schwitzgebel', 'Affiliation': 'University of California at Riverside, USA. Electronic address: eschwitz@ucr.edu.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Cokelet', 'Affiliation': 'University of Kansas, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'Princeton University, USA.'}]",Cognition,['10.1016/j.cognition.2020.104397']
1627,32721845,Implementation of magnesium sulphate as an adjunct to multimodal analgesic approach for perioperative pain control in lumbar laminectomy surgery: A randomized placebo-controlled clinical trial.,"OBJECTIVE


To investigate the effect of systemic intraoperative administration of magnesium sulphate when used in the context of a multimodal pain management plan on analgesics consumption and pain scores, and perioperative outcomes after lumbar laminectomy surgery.
METHODS


Seventy-four patients undergoing lumbar laminectomy were enrolled in this randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to receive magnesium (20 mg/kg iv given as bolus before anesthesia induction followed by 20 mg/kg/h civ until surgery completion) or saline. Hemodynamic variables and desflurane consumption were noted at predefined time-intervals intraoperatively. Primary outcome was postoperative cumulative analgesic consumption over 24 h, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24 h), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points.
RESULTS


Demographics, surgery duration, desflurane requirements, and recovery profile were comparable between groups. Magnesium attenuated hemodynamic response during incision and emergence from anesthesia. Postoperative analgesics consumption in morphine iv equivalents (mean difference -9.24 [95 %CI -13.31, -5.17] mg; p = 0.001) and VAS scores at all-time points of assessment were lower in magnesium group; this effect peaked at 4 h (mean difference -2.15 [95 %CI -3.21,-1.09; p = 0.001]. Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01). No notable adverse effects were recorded.
CONCLUSION


It occurs that magnesium infusion during lumbar laminectomy surgery potentiates perioperative analgesia and reduces analgesic requirements up to 24 h postoperatively. No profound adverse effect on either intraoperative hemodynamics or any other clinically relevant endpoints becomes evident.",2020,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"['lumbar laminectomy surgery', 'Seventy-four patients undergoing lumbar laminectomy']","['Magnesium', 'placebo', 'magnesium (20\u202fmg/kg iv given as bolus before anesthesia induction followed by 20\u202fmg/kg/h civ until surgery completion) or saline', 'magnesium sulphate', 'magnesium', 'morphine']","['adverse effects', 'time-interval to first rescue analgesia', 'intraoperative remifentanil consumption', 'analgesics consumption and pain scores, and perioperative outcomes', 'postoperative cumulative analgesic consumption over 24\u202fh, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24\u202fh), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points', 'analgesic requirements', 'hemodynamic response', 'Postoperative analgesics consumption', 'Hemodynamic variables and desflurane consumption', 'Demographics, surgery duration, desflurane requirements, and recovery profile', 'VAS scores']","[{'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.791883,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tsaousi', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: tsaousig@otenet.gr.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Nikopoulou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: anastasian1991@windowslive.com.'}, {'ForeName': 'Ioakeim', 'Initials': 'I', 'LastName': 'Pezikoglou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: makispez@gmail.com.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Birba', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: bsbvasso@yahoo.gr.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Grosomanidis', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: grosoman@otenet.gr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106091']
1628,32721919,Desmopressin acetate decreases blood loss in patients with massive hemorrhage undergoing gastrointestinal surgery.,"BACKGROUND/AIMS


Intraoperative blood loss more than 400 mL during gastrointestinal surgery is an independent predictor of mortality. Desmopressin acetate (DDAVP) could reduce perioperative blood loss. Few studies have prompted concerning the effects of DDAVP on gastrointestinal surgery. This study was to investigate whether DDAVP can decrease blood loss in patients with massive hemorrhage undergoing gastrointestinal surgery.
MATERIALS AND METHODS


A multiple-centers, double-blind clinical trial was conducted, patients who underwent gastrointestinal surgery were recruited from 3 hospitals, randomly assigned to two different groups. Patients in the treatment group received desmopressin 0.3 ug/kg,30 min once a day after surgery, patients in the control group received 50 ml saline for 30 min. The primary outcome was the changes of hemoglobin at 24 hours after the surgery. And the secondary outcomes included coagulation function, urine volume, serum creatinine, and safety.
RESULTS


There were 59 patients enrolled between 1 June 2015 and 1 June 2017. At 24hr.after surgery, a decrease in hemoglobin in the DDAVP group was significantly lower than that in the NS group (-5.0±6.9 g/L vs. -10.2±9.3g/L, p=0.03). Sonoclot® showed that the platelet function in the DDAVP group was higher than that in NS group at 24 hr. (2.56 ±0.59 vs. 1.91 ±0.72, p<0.05). There was no difference in urine volume and serum creatinine at 24 hr. between two group.
CONCLUSION


DDAVP could reduce post-operation blood loss in patients with massive hemorrhage undergoing surgery by improving the platelet function. We observed no difference in urine volume and serum creatinine in two groups.",2020,"(2.56 ±0.59 vs. 1.91 ±0.72, p<0.05).","['patients with massive hemorrhage undergoing gastrointestinal surgery', 'patients with massive hemorrhage undergoing surgery', 'patients who underwent gastrointestinal surgery were recruited from 3 hospitals', '59 patients enrolled between 1 June 2015 and 1 June 2017']","['Desmopressin acetate (DDAVP', 'Desmopressin acetate', 'DDAVP', '50 ml saline', 'desmopressin']","['platelet function', 'hemoglobin', 'perioperative blood loss', 'urine volume and serum creatinine', 'coagulation function, urine volume, serum creatinine, and safety', 'changes of hemoglobin', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0086135', 'cui_str': 'Desmopressin acetate'}, {'cui': 'C0701195', 'cui_str': 'Desmospray'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",59.0,0.131007,"(2.56 ±0.59 vs. 1.91 ±0.72, p<0.05).","[{'ForeName': 'Li-Chun', 'Initials': 'LC', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, the Sixth Affiliated Hospital of Sun Yat-Sen University，Guangzhou, China.'}, {'ForeName': 'Ying-Fang', 'Initials': 'YF', 'LastName': 'Hu', 'Affiliation': 'Department of Intensive Care Unit, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Intensive Care Unit, the Sixth Affiliated Hospital of Sun Yat-Sen University，Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Xing', 'Affiliation': 'Department of Intensive Care Unit, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Xin-Feng', 'Initials': 'XF', 'LastName': 'Lin', 'Affiliation': 'Department of Intensive Care Unit, The fist affiliated hospital of Guangzhou university of Chinese medicine, Guangzhou, China.'}, {'ForeName': 'Qiu-Ye', 'Initials': 'QY', 'LastName': 'Kou', 'Affiliation': 'Department of Intensive Care Unit, the Sixth Affiliated Hospital of Sun Yat-Sen University，Guangzhou, China.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19021']
1629,32769643,Botulinum Toxin A as a Treatment for Provoked Vestibulodynia: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate pain reduction after two injections of 50 units botulinum toxin A compared with placebo for provoked vestibulodynia.
METHODS


We conducted a double-blinded, placebo-controlled randomized trial of 50 units botulinum toxin A or placebo injected in the bulbocavernosus muscles twice, 3 months apart, in women with provoked vestibulodynia. Primary outcome was self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100). Secondary outcomes were pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress. A sample size of 38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76±31 SD).
RESULTS


Between May 2016 and June 2018, 124 women with provoked vestibulodynia were assessed, and 88 were randomized to botulinum toxin A (BTA group, n=44) or placebo (placebo group, n=44). Primary outcome showed a lower but statistically nonsignificant pain rating by 7 VAS units (95% CI -15.0 to 0.4) in the BTA group compared with the placebo group. Secondary results showed a significant decrease in pain at weekly tampon insertion by 11 VAS units (95% CI -16.6 to 6.0) with botulinum toxin A injection. The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm Hg (95% CI -7.72 to -1.16) in the BTA group compared with the placebo group. No changes were observed for sexual function and distress, but there was a significant increase in women attempting vaginal intercourse in the BTA group (0.27, 95% CI 0.06-0.48). No severe adverse events were reported.
CONCLUSION


Twice-repeated injections of 50 units of botulinum toxin A in women with provoked vestibulodynia did not reduce dyspareunia or pain at tampon use, but secondary outcomes suggested positive effects of the treatment.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02773641.",2020,The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm,"['38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76±31 SD', 'group, n=44', 'women with provoked vestibulodynia', 'Provoked Vestibulodynia', 'Between May 2016 and June 2018, 124 women with provoked vestibulodynia']","['Botulinum Toxin A', 'botulinum toxin A (BTA', '50 units botulinum toxin A or placebo', 'placebo (placebo', 'placebo']","['women attempting vaginal intercourse', 'sexual function and distress', 'severe adverse events', 'pain reduction', 'pain at weekly tampon insertion by 11 VAS units', 'self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100', 'pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress', '10-second endurance strength', 'pain rating', 'maximum contraction strength', 'dyspareunia or pain']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039288', 'cui_str': 'Tampon'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026826', 'cui_str': 'Increased muscle tone'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",124.0,0.796461,The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Haraldson', 'Affiliation': 'Department of Clinical Sciences, Division of Obstetrics and Gynecology, Karolinska Institutet Danderyd Hospital, Stockholm, and the Center for Clinical Research, Uppsala University, County Council of Västmanland Central Hospital, and the School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mühlrad', 'Affiliation': ''}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Heddini', 'Affiliation': ''}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Nilsson', 'Affiliation': ''}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bohm-Starke', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004008']
1630,32769647,Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.,"OBJECTIVE


To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.
METHODS


Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.
RESULTS


Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure.
CONCLUSION


Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01959347.",2020,Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence.,"['Four hundred three women who participated in a randomized trial that compared', 'counseling women with mixed incontinence who are considering surgery', 'women with mixed urinary incontinence', 'Women With Mixed Urinary Incontinence']","['Midurethral Sling', 'Sling type (retropubic vs transobturator', 'perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling', 'midurethral sling', 'midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone']","['Worse UDI urgency scores', 'UDI (Urogenital Distress Inventory)-total score', 'Subjective failure', 'body mass index', 'Valsalva leak point pressure', 'mean incontinence episodes', 'Overall treatment failure', 'detrusor overactivity on cystometrogram (OR 2.25, aOR', 'overall failure', 'Objective failure']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}, {'cui': 'C0200000', 'cui_str': 'Cystometrogram'}, {'cui': 'C4068875', 'cui_str': '2.25'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",403.0,0.319142,Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence.,"[{'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ""Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, Kaiser Permanente, Downey, California; the Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico; the Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; the Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, Pennsylvania; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; and Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.""}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': ''}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Weidner', 'Affiliation': ''}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': ''}, {'ForeName': 'Beri', 'Initials': 'B', 'LastName': 'Ridgeway', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Borello-France', 'Affiliation': ''}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': ''}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003989']
1631,32769657,Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder outcomes 12 months after retropubic midurethral sling surgery.
METHODS


The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique. The primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention. Secondary outcomes included outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry. Sample size of 159 in each arm (N=318) was planned for a superiority trial, hypothesizing a 10% difference in primary outcome.
RESULTS


From September 2015 to December 2017, 506 women were screened and 318 were randomized. Baseline characteristics were similar in each arm. At 12 months, 253 (79.6%) women provided information on primary outcome: 40 of 128 (31.3%) patients with midurethral slings tensioned by Scissor experienced abnormal bladder, compared with 23 of 125 (18.4%) of those with midurethral slings tensioned by Babcock (P=.018, relative difference 12.9%). Secondary analyses favored Babcock for median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis. Uroflowmetry parameters suggest the Scissor technique is more restrictive. Rates of mesh erosion were lower for the Scissor arm. No differences occurred in proportions of women experiencing patient reported persistent SUI after surgery.
CONCLUSION


Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock. Both techniques provided a comparable patient reported cure for SUI at 12 months. Women with midurethral slings tensioned by Scissors experienced more intervention for obstruction, whereas those with midurethral slings tensioned by Babcock experienced higher rates of mesh erosion. This information about how the postoperative courses differ allows surgeons to better counsel patients preoperatively or tailor their choice of technique.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02480231.
FUNDING SOURCE


Boston Scientific.",2020,Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock.,"['From September 2015 to December 2017, 506 women were screened and 318 were randomized', 'allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique']","['retropubic midurethral sling surgery', 'Babcock clamp holding a loop of tape', 'Midurethral Sling Tensioning', 'Mayo Scissor']","['Rates of mesh erosion', 'primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention', 'median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis', 'Abnormal bladder outcomes', 'abnormal bladder', 'rates of mesh erosion', 'outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C4505203', 'cui_str': 'A-Loop'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C1272733', 'cui_str': 'Mayo scissors'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}]",506.0,0.669678,Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock.,"[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Brennand', 'Affiliation': 'Department of Obstetrics & Gynecology, the Department of Community Health Sciences, the Division of Urology, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, the Department of Obstetrics & Gynecology, University of British Columbia, Vancouver, British Columbia, the Department of Obstetrics & Gynecology, University of Manitoba, Winnipeg, Manitoba, the Department of Obstetrics & Gynecology, University of Toronto, Toronto, Ontario, the Department of Obstetrics & Gynecology, University of Alberta, Edmonton, Alberta, Canada; and the Department of Obstetrics & Gynecology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Guosong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Houlihan', 'Affiliation': ''}, {'ForeName': 'Dobrochna', 'Initials': 'D', 'LastName': 'Globerman', 'Affiliation': ''}, {'ForeName': 'Louise-Helene', 'Initials': 'LH', 'LastName': 'Gagnon', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Birch', 'Affiliation': ''}, {'ForeName': 'Momoe', 'Initials': 'M', 'LastName': 'Hyakutake', 'Affiliation': ''}, {'ForeName': 'Kevin V', 'Initials': 'KV', 'LastName': 'Carlson', 'Affiliation': ''}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Al-Shankiti', 'Affiliation': ''}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': ''}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Lazare', 'Affiliation': ''}, {'ForeName': 'Shunaha', 'Initials': 'S', 'LastName': 'Kim-Fine', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004027']
1632,32769658,Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial.,"OBJECTIVE


To assess whether outpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing elective labor induction shortens the time from admission to delivery.
METHODS


We performed a randomized controlled trial of patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5. Women were randomized 1:1 to outpatient or inpatient transcervical Foley. In the outpatient group, the Foley was inserted the day before admission for scheduled induction; insertion was performed at scheduled admission in the inpatient group. The primary outcome was duration of time from admission to the labor and delivery unit to delivery. With 80% power and a two-sided α of 0.05, a sample size of 126 was estimated to detect at least a 5-hour mean difference in time from admission to delivery between groups from a baseline duration of 19±10 hours.
RESULTS


From May 2018 to October 2019, 126 women were randomized, 63 in each group. Baseline characteristics were balanced between groups, except that body mass index (31±5.4 vs 34±7.5, P=.01) and group B streptococcus colonization (31% vs 54%, P=.01) were lower in the outpatient group. The time from admission to delivery was shorter in the outpatient group (17.4±7.4 vs 21.7±9.1 hours, P<.01, mean difference 4.3 hours, 95% CI 1.3-7.2). Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR] 4.7, 95% CI 1.4-15.4, P<.01), as was median modified Bishop score on admission (3 vs 1, P<.01). Cesarean delivery (24% vs 32%, RR 0.8, 95% CI 0.4-1.3, P=.32) and chorioamnionitis (22% vs 13%, RR 1.8, 95% CI 0.8-3.9, P=.16) were not significantly different between groups.
CONCLUSION


In nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery.
CLINCAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03472937.",2020,"Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR]","['nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a', 'patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5', 'Nulliparous Women', 'nulliparous women undergoing elective labor induction shortens the time from admission to delivery', 'From May 2018 to October 2019, 126 women were randomized, 63 in each group']","['outpatient cervical ripening with a transcervical Foley catheter', 'transcervical Foley catheter', 'Outpatient Foley Catheter', 'inpatient transcervical Foley']","['duration of time from admission to the labor and delivery unit to delivery', 'Cesarean delivery', 'relative risk [RR', 'time from admission to delivery', 'streptococcus colonization', 'chorioamnionitis']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1321138', 'cui_str': 'Labor and delivery unit'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}]",126.0,0.316198,"Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR]","[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Ausbeck', 'Affiliation': ""Center for Women's Reproductive Health, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; and Tri-State Perinatology, Deaconess-The Women's Hospital, Newburgh, Indiana.""}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Jauk', 'Affiliation': ''}, {'ForeName': 'Yumo', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Files', 'Affiliation': ''}, {'ForeName': 'Spencer G', 'Initials': 'SG', 'LastName': 'Kuper', 'Affiliation': ''}, {'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Subramaniam', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ''}, {'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ''}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004041']
1633,32769027,Does CPAP treat depressive symptoms in individuals with OSA? An analysis of two 12-week randomized sham CPAP-controlled trials.,"BACKGROUND


Depression is common in patients with obstructive sleep apnea (OSA). Whether treating OSA with continuous positive airway pressure (CPAP) improves depressive symptoms remains inconclusive. We examined the impact of CPAP on depressive symptoms in OSA patients compared to sham CPAP.
METHODS


A sub-analysis of two previous randomized sham-controlled trials was conducted. 126 male OSA patients (age = 51 ± 11 years; BMI = 32.0 ± 5.1 kg/m 2 ; apnea hypopnea index = 42.4 ± 22.6 events/hour) were randomised either to therapeutic CPAP (n = 65) or sham CPAP (n = 61). Depressive symptoms were measured using the Depression, Anxiety and Stress Scale (DASS). The main outcome was the change in the DASS depression score (DASSD) after three months between the therapeutic and sham CPAP arms.
RESULTS


The change in DASSD at three months did not differ between therapeutic and sham CPAP (mean difference: 0.5, 95% CI -3.6 to 4.6, p = 0.80). There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9). In a secondary analysis of patients with baseline depression, adherent therapeutic CPAP use was associated with a greater reduction in DASSD scores compared to non-adherers (-10.0, 95% CI -18.3 to -1.8, p = 0.019).
CONCLUSIONS


Overall, three months of CPAP did not significantly improve depression scores in OSA patients. Adherent use of therapeutic CPAP in patients with baseline depressive symptoms was associated with a reduction in symptom score. Future trials involving OSA patients with higher depressive symptoms will enable us to understand the complex interaction between OSA and depression.",2020,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","['OSA patients with higher depressive symptoms', '126 male OSA patients (age\xa0=\xa051\xa0±\xa011 years; BMI\xa0=\xa032.0\xa0±\xa05.1\xa0kg/m 2 ; apnea hypopnea index\xa0=\xa042.4\xa0±\xa022.6 events/hour', 'patients with baseline depressive symptoms', 'individuals with OSA', 'OSA patients', 'patients with obstructive sleep apnea (OSA']","['OSA with continuous positive airway pressure (CPAP', 'sham CPAP', 'CPAP', 'therapeutic CPAP']","['depression scores', 'Depression, Anxiety and Stress Scale (DASS', 'change in DASSD', 'Depressive symptoms', 'DASSD scores', 'DASS depression score (DASSD', 'depressive symptoms']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",126.0,0.313538,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Department of Sleep Medicine, Surgery and Science, Department of Respiratory and Critical Care Medicine, Changi General Hospital, Singapore.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Melehan', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California, USA.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; School of Psychology, Brain and Mind Centre and Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: camilla.hoyos@sydney.edu.au.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.021']
1634,32769065,The effects of foot reflexology on agitation and extubation time in male patients following coronary artery bypass surgery: A randomized controlled clinical trial.,"BACKGROUND AND PURPOSE


This study examined the effects of foot reflexology on agitation and extubation time of male patients following coronary artery bypass graft surgery.
MATERIALS AND METHODS


In this randomized three-arm controlled clinical trial, participants (n = 120) were randomly assigned to the intervention, placebo, or control groups. The intervention group received foot reflexology massage for 15 min. Agitation was assessed using the Richmond Agitation- Sedation Scale before the intervention (Time 1) and immediately (Time 2) and 10 min after the intervention (Time 3). Extubation time was measured as the time from gaining full consciousness to endotracheal extubation.
RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001). Also, extubation time was significantly shorter in the intervention group (p < 0.01).
CONCLUSION


Foot reflexology may be introduced as a nursing intervention to facilitate the weaning process in the cardiac ICUs.",2020,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","['male patients following coronary artery bypass surgery', 'male patients following coronary artery bypass graft surgery', 'participants (n\xa0=\xa0120']","['foot reflexology', 'foot reflexology massage', 'placebo']","['agitation and extubation time', 'Extubation time', 'extubation time', 'Richmond Agitation- Sedation Scale', 'Agitation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]",120.0,0.0559303,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Allahbakhhsian', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Gholizadeh', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, Australia. Electronic address: Leila.gholizadeh@uts.edu.au.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Allahbakhshian', 'Affiliation': 'Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences. Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'Faculty of Public Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Abbaszadeh', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: abbaszadeh_yaser@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101201']
1635,32779460,[Practical application of ophthalmic nutraceuticals in patients with dry form of age-related macular degeneration].,"Development and progression of age-related macular degeneration (AMD) is associated with insufficiency of protective antioxidant systems of the body. Nutraceutical medications can positively affect the course of the disease and the visual functions of patients with AMD.
PURPOSE


To conduct a placebo-controlled clinical monitoring of visual functions in patients with dry AMD while taking a drug Complex that corresponds to the AREDS 2 formula.
MATERIAL AND METHODS


The study included 90 people in 3 equivalent parallel groups, two of which were represented by patients with AMD who took the Complex for 3-6 months or Placebo for 3 months. The third group included healthy subjects of the same age. In addition to standard eye examination, participants underwent evaluation of the macular pigment optical density (MPOD), spatial-frequency contrast sensitivity (CS), photostress test, and reading parameters on the Salzburg Reading Desk device. The changes of blood plasma antioxidant activity (AOA) were also evaluated in the main group.
RESULTS


By day 90 of the study, patients of the main group showed statistically significant ( p <0.001) growth of MPOD from 0.24±0.13 to 0.32±0.1, reduction of photostress recovery time from 68.2±17.8 to 57.3±17.5 seconds, improvement of high-spatial-frequency CS - from 25.0±8.2 to 30.6±6.8 dB, increase of near visual acuity logMAR from 0.22±0.04 to 0.19±0.03 and reading speed, and decrease of reading mistakes. Statistically significant ( p <0.05) reduction of in AOA was seen during the observation period from 1.52±0.16 to 1.68±0.16. Patients of the main group who received the Complex for 180 days demonstrated additional improvements of visual functions.
CONCLUSION


The drug Complex corresponding to the AREDS 2 formula contributes to a significant increase in MPOD, improvements of visual functions and overall antioxidant status of patients, which confirms the feasibility of its use in patients with dry AMD.",2020,"By day 90 of the study, patients of the main group showed statistically significant ( p <0.001) growth of MPOD from 0.24±0.13 to 0.32±0.1, reduction of photostress recovery time from 68.2±17.8 to 57.3±17.5 seconds, improvement of high-spatial-frequency CS - from 25.0±8.2 to 30.6±6.8 dB, increase of near visual acuity logMAR from 0.22±0.04 to 0.19±0.03 and reading speed, and decrease of reading mistakes.","['patients with AMD', 'patients with dry AMD', 'healthy subjects of the same age', 'patients with dry form of age-related macular degeneration', '90 people in 3 equivalent parallel groups, two of which were represented by patients with AMD who took the Complex for 3-6 months or Placebo for 3 months']",['placebo'],"['photostress recovery time', 'AOA', 'near visual acuity logMAR', 'blood plasma antioxidant activity (AOA', 'MPOD', 'reading mistakes', 'visual functions and overall antioxidant status', 'visual functions', 'macular pigment optical density (MPOD), spatial-frequency contrast sensitivity (CS), photostress test, and reading parameters on the Salzburg Reading Desk device', 'growth of MPOD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C3888461', 'cui_str': 'Dry age-related macular degeneration'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429489', 'cui_str': 'Photostress recovery time'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0430873', 'cui_str': 'Photostress test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",90.0,0.0372968,"By day 90 of the study, patients of the main group showed statistically significant ( p <0.001) growth of MPOD from 0.24±0.13 to 0.32±0.1, reduction of photostress recovery time from 68.2±17.8 to 57.3±17.5 seconds, improvement of high-spatial-frequency CS - from 25.0±8.2 to 30.6±6.8 dB, increase of near visual acuity logMAR from 0.22±0.04 to 0.19±0.03 and reading speed, and decrease of reading mistakes.","[{'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Eskina', 'Affiliation': 'Academy of post-graduate education of the Federal Clinical Scientific Center of the Federal Medical-Biological Agency, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Belogurova', 'Affiliation': 'Ophthalmological clinic «Sphera» of Professor Eskina, Moscow, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Gvetadze', 'Affiliation': 'Ophthalmological clinic «Sphera» of Professor Eskina, Moscow, Russia.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Smorchkova', 'Affiliation': 'Ophthalmological clinic «Sphera» of Professor Eskina, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013604186']
1636,32779967,10-kHz spinal cord stimulation treatment for painful diabetic neuropathy: results from  post-hoc  analysis of the SENZA-PPN study.,"Aim:  Previous studies of 10 kHz spinal cord stimulation demonstrated its safety and efficacy for treatment of neuropathic pain of the trunk and/or limbs. This study analyzed data from a subset of subjects with painful diabetic neuropathy enrolled in a prospective, multicenter study of peripheral polyneuropathy with various etiologies.  Materials & methods:  Of the eight subjects that had permanent devices, seven attended the 12-month follow-up assessment.  Results & conclusion:  At 12 months, 6/7 subjects were treatment responders (≥50% pain relief) and had pain remission (visual analog scale ≤ 3.0 cm). Worsening of neurologic deficits was not reported in any subject. Instead, 5/7 subjects showed improvements in sensory testing and/or reflexes. These results support further investigation of 10 kHz spinal cord stimulation as a safe and effective treatment for intractable painful diabetic neuropathy.",2020,Worsening of neurologic deficits was not reported in any subject.,"['neuropathic pain of the trunk and/or limbs', 'painful diabetic neuropathy', 'subjects with painful diabetic neuropathy enrolled in a prospective, multicenter study of peripheral polyneuropathy with various etiologies', 'eight subjects that had permanent devices']","['10\xa0kHz spinal cord stimulation', 'kHz spinal cord stimulation', 'kHz\xa0spinal cord stimulation treatment']","['Worsening of neurologic deficits', 'pain remission', 'sensory testing and/or reflexes']","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}]",,0.0351065,Worsening of neurologic deficits was not reported in any subject.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Galan', 'Affiliation': 'Georgia Pain Care, Stockbridge, GA 30281, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': ""KC Pain Centers, Lee's Summit, MO 64086, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Georgia Pain Care, Stockbridge, GA 30281, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ 20852, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ 20852, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Rotte', 'Affiliation': 'Nevro Corp., Redwood City, CA 94065, USA.'}, {'ForeName': 'Jeyakumar', 'Initials': 'J', 'LastName': 'Subbaroyan', 'Affiliation': 'Nevro Corp., Redwood City, CA 94065, USA.'}]",Pain management,['10.2217/pmt-2020-0033']
1637,32774508,Chloroquine and COVID-19: Should We Care about Ototoxicity?,"Introduction   Severe acute respiratory syndrome coronavirus 2 was first described in December 2019 in China leading to a Public Health Emergency of International Concern. It was named by the World Health Organization as Coronavirus Disease 2019 (COVID-19), and it garnered unprecedented attention from public health researchers around the world, and studies analyzing chloroquine and hydroxychloroquine as a possible therapy have arisen in the last 2 months.  Objective   To review the literature and describe updated facts about the ototoxicity of chloroquine and hydroxychloroquine, an important side effect that can be present in patients with COVID-19 treated with these drugs.  Data Synthesis   The most typical treatment regimen is 5 days of hydroxychloroquine at daily doses of 400 to 600 mg. There is no randomized clinical trial that can prove so far the efficacy of this medication, and few studies have evaluated adverse events potentially linked to their use in patients with COVID-19. While there is no concrete evidence on the incidence of ototoxicity using chloroquine in the short term, we need to consider that, as a pandemic disease, millions of patients with COVID-19 may receive this treatment, and ototoxicity can be a possible adverse event.  Conclusion   Despite the urgent global situation caused by the COVID-19, the risk of irreversible hearing loss may outweigh the unproven benefit of using hydroxychloroquine or chloroquine, especially in patients with mild forms of COVID-19, who may be cured with supportive treatment. The potential hearing loss that can be caused by these medications may advise against their use in COVID-19 patients.",2020,The potential hearing loss that can be caused by these medications may advise against their use in COVID-19 patients.,"['patients with COVID-19', 'patients with mild forms of COVID-19, who may be cured with supportive treatment', 'Introduction  \u2003Severe acute respiratory syndrome coronavirus 2 was first described in December 2019 in China leading to a Public Health Emergency of International Concern', 'patients with COVID-19 treated with these drugs']","['Chloroquine and COVID-19', 'hydroxychloroquine or chloroquine', 'hydroxychloroquine', 'chloroquine', 'chloroquine and hydroxychloroquine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0582394,The potential hearing loss that can be caused by these medications may advise against their use in COVID-19 patients.,"[{'ForeName': 'Eduardo Machado Rossi', 'Initials': 'EMR', 'LastName': 'Monteiro', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Maria Fernanda Lima', 'Initials': 'MFL', 'LastName': 'Nascimento', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Thayanne Rachel Cangussu', 'Initials': 'TRC', 'LastName': 'Brito', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Marcos Correia', 'Initials': 'MC', 'LastName': 'Lima', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Laura Rodrigues', 'Initials': 'LR', 'LastName': 'Sefair', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Maisa Mendes', 'Initials': 'MM', 'LastName': 'Pedrosa', 'Affiliation': 'Department of Otorhinolaryngology, Hospital Felício Rocho, Belo Horizonte, MG, Brazil.'}]",International archives of otorhinolaryngology,['10.1055/s-0040-1714142']
1638,32776649,The benefits of mechanical insufflator-exsufflator compared to autogenic drainage in adults with cystic fibrosis.,"BACKGROUND


Autogenic drainage (AD) is used for airway clearance in individuals with cystic fibrosis (CF). The mechanical insufflator-exsufflator (MI-E) device is commonly used in patients with neuromuscular diseases for airway clearance by increasing inspiratory volume and expiratory flow. MI-E use has not been studied extensively in CF patients.
OBJECTIVES


To examine whether there are advantages to using the MI-E device in patients with CF.
SUBJECTS


Fourteen males and eight females from the national center for CF, with an average FEV 1  of 54% were recruited DESIGN: Prospective cross-over trial (IRB 3009-16-SMC).
INTERVENTION


Subjects received either AD or MI-E in a random order. Sputum was collected and weighed immediately after treatment. Subjects performed lung function tests at baseline, 20 minutes after and 1 hour after treatment; additionally, a 2-minute walk test was performed at the end of all lung function tests. Saturation, dyspnea scores while resting and after a 2-minute walk and subjective fatigue were recorded.
RESULTS


Thirty-six percent more sputum was collected following MI-E than AD treatment (P < .0001). A significant difference in saturation in response to the 2MWT was noted in both treatments significantly less desaturation was recorded after the 2MWT in the MI-E treatment (P < .01).
CONCLUSIONS


Treatment with the MI-E was more effective for clearing sputum in CF subjects, initial evidence suggests that the MI-E may be successfully incorporated into treatment protocols. Further studies are needed to assess the long-term benefits of MI-E in patients with CF.",2020,"A significant difference in saturation in response to the 2MWT was noted in both treatments significantly less desaturation was recorded after the 2MWT in the MI-E treatment (P<0.01).
","['individuals with Cystic fibrosis (CF', 'adults with Cystic Fibrosis (CF', 'patients with neuromuscular diseases', '14 males and 8 females from the national center for CF, with an average FEV 1  of 54% were recruited DESIGN', 'patients with CF']","['autogenic drainage (AD', 'mechanical insufflator-exsufflator (MI-E', 'AD or MI-E', 'Autogenic drainage (AD']","['Saturation, dyspnea scores while resting and after a 2-minute walk and subjective fatigue', 'lung function tests', 'saturation in response to the 2MWT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0454507', 'cui_str': 'Autogenic pulmonary drainage'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0021639', 'cui_str': 'Insufflator'}]","[{'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",14.0,0.0189022,"A significant difference in saturation in response to the 2MWT was noted in both treatments significantly less desaturation was recorded after the 2MWT in the MI-E treatment (P<0.01).
","[{'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Helper', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Einat', 'Initials': 'E', 'LastName': 'Kodesh', 'Affiliation': 'Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Sokol', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Hakimi', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Vilozni', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Efrati', 'Affiliation': ""Pediatric Pulmonary Unit, The National Center for Cystic Fibrosis, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel.""}]",Pediatric pulmonology,['10.1002/ppul.25020']
1639,32777381,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino emergency department patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building, Rooms 102 and 104, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106104']
1640,32777706,Comparison of the efficacy and safety of recombinant human growth hormone in treating idiopathic short stature and growth hormone deficiency in children.,"PURPOSE


The present study aimed to compare the efficacy and safety of recombinant human growth hormone (rhGH) therapy between children with idiopathic short stature (ISS) and growth hormone deficiency (GHD).
METHODS


A total of 150 pediatric patients with ISS and 153 pediatric patients with GHD who received rhGH treatment for more than one year from 2005 to 2016 were enrolled. Growth velocity (GV); height standard deviation (HtSD); insulin-like growth factor-1 standard deviation (IGF-1SD); body mass index (BMI); and the incidence of fasting hyperglycemia, fasting hyperinsulinemia, and hypothyroidism were recorded and compared.
RESULTS


At the beginning of treatment, chronological age, bone age, height, and BMI were not statistically significant between the two groups. rhGH dosage in ISS was significantly higher compared with GHD (P = 0). GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05). HtSD increased in the two groups after rhGH therapy. HtSD at the beginning and after three years of therapy was not different between groups except for after half a year of therapy. HtSD in patients with ISS was significantly higher compared with GHD (P < 0 .05). The incidence of hypothyroidism was significantly higher in the GHD group compared with the ISS group (13.72% vs. 6.0%; P < 0.05). Moreover, the incidence of hyperinsulinemia was significantly higher in the ISS group compared with the GHD group (15.33% vs. 7.84%; P < 0 .05).
CONCLUSIONS


rhGH increases growth in children with ISS and GHD. Fasting insulin and thyroid function were closely monitored for long-term follow up.",2020,"GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05).","['children with ISS and GHD', 'children with idiopathic short stature (ISS) and growth hormone deficiency (GHD', 'children', 'patients with ISS', '150 pediatric patients with ISS and 153 pediatric patients with GHD who received rhGH treatment for more than one year from 2005 to 2016 were enrolled']","['recombinant human growth hormone', 'GHD', 'recombinant human growth hormone (rhGH) therapy']","['incidence of hyperinsulinemia', 'Fasting insulin and thyroid function', 'efficacy and safety', 'Growth velocity (GV); height standard deviation (HtSD); insulin-like growth factor-1 standard deviation (IGF-1SD); body mass index (BMI); and the incidence of fasting hyperglycemia, fasting hyperinsulinemia, and hypothyroidism', 'incidence of hypothyroidism', 'HtSD', 'rhGH dosage in ISS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}]",150.0,0.0207075,"GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Han-Hua', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Luo', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Yan-Qin', 'Initials': 'YQ', 'LastName': 'Ying', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. Electronic address: yingyanqin@126.com.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101331']
1641,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
1642,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
1643,32778139,Correction to: Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['Ugandan neonates'],['BCG vaccination'],[],"[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0199804', 'cui_str': 'BCG vaccination'}]",[],,0.0719374,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Prentice', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Sarah.prentice@lshtm.ac.uk.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Dockrell', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'MRC/Uganda Virus Research Institute on AIDS, Plot 51-59, Nakiwogo Road, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cose', 'Affiliation': 'Department of Infection and Immunology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",Trials,['10.1186/s13063-020-04594-7']
1644,32772684,Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial.,"BACKGROUND AND PURPOSE


To quantify workflow metrics in patients receiving stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography) in either a computed-tomography scanner suite (CT-Transit [CTT]) or an angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT) before undergoing mechanical thrombectomy.
METHODS


Prospective, single-center investigator initiated randomized controlled trial in a comprehensive stroke center focusing on time from imaging to groin puncture (primary end point) and time from hospital admission to final angiographic result (secondary end point) in patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway.
RESULTS


The trial was stopped early after the enrollment of n=60 patients (CTT: n=34/60 [56.7 %]; DTAS: n=26/60 [43.3%]) of n=110 planned patients because of a preplanned interim analysis. Time from imaging to groin puncture was shorter in DTAS-patients (in minutes, median [interquartile range]: CTT: 26 [23-32]; DTAS: 19 [15-23];  P  value: 0.001). Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS (CTT: 12 (7-18); DTAS: 21 (15-25),  P  value: 0.007). Time from hospital admission to final angiographic reperfusion was comparable between patient groups (CTT: 78 [58-92], DTAS: 80 [66-118];  P  value: 0.067).
CONCLUSIONS


This trial showed a reduction in time from imaging to groin-puncture when patients are transferred directly to the angiosuite for advanced stroke-imaging compared with imaging in a CT scanner suite. This time saving was outweighed by a longer admission to imaging time and could not translate into a shorter time to final angiographic reperfusion in this trial.",2020,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"['n=60 patients (CTT: n=34/60 [56.7 %]; DTAS', 'Patients Receiving Mechanical Thrombectomy', 'patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway', 'patients receiving']","['angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT', 'Direct Transfer to Angio-Suite Versus Computed Tomography-Transit', 'stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography', 'DTAS', 'computed-tomography scanner suite (CT-Transit [CTT']","['Time from imaging to groin puncture', 'Time from hospital admission to final angiographic reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.0900532,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"[{'ForeName': 'Johannes A R', 'Initials': 'JAR', 'LastName': 'Pfaff', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herweh', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ulfert', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nagel', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029905']
1645,32707101,The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).,"BACKGROUND


Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
METHODS


We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
PROJECTED OUTCOMES


This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.",2020,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","['partnership with a primary care clinic in a low-income, majority Latino community', 'Families with 2- to 5-year-old children', 'integrated primary care (the healthy communities 4 healthy students study']",['Family Check-Up 4 Health (FCU4Health) program'],"['RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance', 'cost, acceptability, appropriateness, and feasibility', 'child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",,0.0514529,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","[{'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': ""REACH Institute, Arizona State University, Tempe, AZ, USA; Phoenix Children's Hospital, Phoenix, AZ, USA. Electronic address: Cady.Berkel@asu.edu.""}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology (Ce-PIM), Department of Psychiatry and Behavioral Sciences, Department of Preventive Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Meg M', 'Initials': 'MM', 'LastName': 'Bruening', 'Affiliation': 'Department of Nutrition, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mauricio', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Winslow', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ray', 'Affiliation': 'Bayless Integrated Healthcare, Phoenix, AZ, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bourne', 'Affiliation': 'Southwest Maricopa Regional Council, First Things First, Peoria, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106088']
1646,32712460,Effect of a newly developed ready-to-use supplementary food on growth indicators in children with mild to moderate malnutrition.,"OBJECTIVES


Malnutrition is one of the leading causes of death among children younger than five years. In this study, we aimed to formulate a ready-to-use supplementary food (RUSF), based on local food products, and investigate its efficacy on growth indicators in children with mild to moderate malnutrition.
STUDY DESIGN


This is a randomized controlled clinical trial.
METHODS


This study was performed in six health centers in Shahr-e-Rey, Tehran, Iran, between April and October 2017. One hundred children, aged 24-59 months, with mild to moderate malnutrition (weight-for-height Z-score [WHZ] between -3 and -1) were randomly assigned to two groups to receive either 1-3 sachets of RUSF or normal diet for 8 weeks. All mothers and caregivers received nutrition education. Growth indicators including weight and height, WHZ, and body mass index (BMI), along with clinical outcomes, were assessed.
RESULTS


Children who received RUSF had a significant increase in weight (1.44 ± 0.38 vs 0.7 ± 0.32 kg, respectively, P < 0.001), and BMI (1.2 ± 0.47 vs 0.35 ± 0.33 kg/m 2 , respectively, P < 0.001) compared with the control group. There was a greater daily weight gain during the first 4 weeks (P < 0.001) and throughout the study (P = 0.013) in the RUSF group. Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027). Children in the RUSF group had more improvement in WHZ (1.18 ± 0.41 vs 0.41 ± 0.31, P < 0.001) after supplementation. Besides, 92% of the RUSF and 12% of the control group reached to WHZ > -1 at the end of the study (P < 0.001). There was lower prevalence of diarrhea (12% vs 28.6%, respectively, P = 0.01) and marginally lower fever (16% vs 36.7%, respectively, P = 0.05) in the intervention than in the control group.
CONCLUSIONS


A newly developed RUSF improved growth indicators and clinical outcomes in children with mild to moderate malnutrition.
CLINICAL TRIAL REGISTRY NUMBER


IRCT2017021315536N6 (registered at www.irct.ir).",2020,Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027).,"['children with mild to moderate malnutrition', 'One hundred children, aged 24-59 months, with mild to moderate malnutrition (weight-for-height Z-score [WHZ] between\xa0-3 and\xa0-1', 'six health centers in Shahr-e-Rey, Tehran, Iran, between April and October 2017', 'children younger than five years']","['RUSF or normal diet', 'nutrition education', 'RUSF', 'ready-to-use supplementary food (RUSF']","['diarrhea', 'weight', 'Daily height gain', 'weight and height, WHZ, and body mass index (BMI', 'BMI', 'daily weight gain', 'WHZ', 'fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",100.0,0.0904359,Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Azimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alipoor', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moslemi', 'Affiliation': 'Food and Drug Laboratories Research Center, Food and Drug Administration, Ministry of Health and Medical Education, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran; Cardiac Primary Prevention Research Center (CPPRC), Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hosseinzadeh.md.phd@gmail.com.'}]",Public health,['10.1016/j.puhe.2020.06.025']
1647,32712560,Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson's disease psychosis.,"INTRODUCTION


Pimavanserin is a selective 5-HT 2A  inverse agonist/antagonist approved for treating hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Results from short-term, placebo-controlled studies demonstrated a positive benefit/risk profile. This multi-year, open-label study assessed long-term safety and tolerability of pimavanserin.
METHODS


This was an open-label extension (OLE) study in patients previously completing a double-blind, placebo-controlled study or a previous OLE study. Safety was evaluated from adverse events (AEs), clinical laboratory results, motor symptoms, electrocardiograms (ECG), and mortality. Durability of response was assessed from the Clinical Global Impression-Severity (CGI-S) scale and Caregiver Burden Scale (CBS).
RESULTS


Of 459 participants treated in this OLE study (average age 71.2 years), the median duration of treatment was 454 days. Over the entire study period (approximately 11 years), ≥1 AE occurred in 392 (85.4%) patients; the majority were of mild to moderate intensity, with fall (32.0%), urinary tract infection (19.0%), and hallucination (13.7%) most common. Serious AEs occurred in 188 (41.0%) patients, and an AE leading to study termination or dose discontinuation occurred in 133 (29.0%) patients. Sixty-one patients died, 59 (12.9%) during treatment or within 30 days after the last dose of study drug; the observed mortality rate was 6.45 per 100 patient-years of exposure. Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
CONCLUSIONS


Long-term treatment with pimavanserin 34 mg once daily demonstrated a favorable benefit/risk profile with no unexpected safety concerns. Mortality rates suggested no increased risk following long-term treatment.",2020,"Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
","[""Parkinson's disease psychosis"", '459 participants treated in this OLE study (average age 71.2 years']","['pimavanserin', 'Pimavanserin', 'placebo']","['adverse events (AEs), clinical laboratory results, motor symptoms, electrocardiograms (ECG), and mortality', 'Mean scores for the CGI-S scale and CBS', 'Clinical Global Impression-Severity (CGI-S) scale and Caregiver Burden Scale (CBS', 'urinary tract infection', 'AE leading to study termination or dose discontinuation', 'Serious AEs', 'Mortality rates', 'observed mortality rate', 'median duration of treatment']","[{'cui': 'C3805119', 'cui_str': ""Parkinson's disease psychosis""}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",459.0,0.12366,"Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
","[{'ForeName': 'Clive G', 'Initials': 'CG', 'LastName': 'Ballard', 'Affiliation': 'University of Exeter Medical School, Exeter, UK. Electronic address: c.ballard@exeter.ac.uk.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kreitzman', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Long Island, Commack, NY, USA.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'I-Yuan', 'Initials': 'IY', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Norton', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demos', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Tihomir V', 'Initials': 'TV', 'LastName': 'Ilic', 'Affiliation': 'Medical Faculty of Military Medical Academy, Belgrade, Serbia.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Azulay', 'Affiliation': 'Timone Hospital, Marseille, France.'}, {'ForeName': 'Joaquim J', 'Initials': 'JJ', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Abler', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.06.026']
1648,32717295,Effects of Nicotine on Task Switching and Distraction in Non-smokers. An fMRI Study.,"Nicotine improves sustained attention and reduces distractor interference, promoting cognitive stability. While stable performance may be beneficial in some situations, others require flexible updating of task demands. Frontoparietal networks, basal ganglia and thalamus contribute to an optimal balance of stable and flexible performance. We aimed to test how the cholinergic agonist nicotine modulates this balance and used an ongoing visual task including switch and distractor trials to gauge cognitive flexibility and stability respectively. Young healthy non-smokers (n = 39) received either a 7 mg transdermal nicotine or placebo patch in a double-blind, within-subject design one hour prior to performing the task in a 3 T MR scanner. Nicotine enhanced response times in all task conditions but did not significantly impact distractor or switch costs. Neurally, there was no significant nicotine induced modulation of distractor- or switch-related activity on group level. However, a brain-behaviour correlation analysis revealed that the nicotine-induced alterations of distractor costs correlated positively with distractor-related neural activity in the right intraparietal sulcus and the right pulvinar nucleus of the thalamus. We suggest that a nicotinic contribution to balancing stability and flexibility is weak in young healthy non-smokers. The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.",2020,"The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.","['young healthy non-smokers', 'non-smokers', 'Young healthy non-smokers (n=39']","['Nicotine', 'cholinergic agonist nicotine', 'transdermal nicotine or placebo patch', 'nicotine']","['task switching and distraction', 'distractor costs', 'distractor interference', 'sustained attention and reduces distractor interference, promoting cognitive stability', 'impact distractor or switch costs']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0242894', 'cui_str': 'Cholinergic Agonist'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0408686,"The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ahrens', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christiane M', 'Initials': 'CM', 'LastName': 'Thiel', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany; Cluster of Excellence ""Hearing4all"", Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany; Research Center Neurosensory Science, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany. Electronic address: christiane.thiel@uni-oldenburg.de.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.029']
1649,32718528,"Aprepitant in the Treatment of Subacute Sclerosing Panencephalitis: A Randomized, Double-Blind, Placebo-Controlled Study.","BACKGROUND


Aprepitant is a neurokinin-1 receptor antagonist approved for the treatment of chemotherapy-induced nausea. We aimed to investigate the safety and efficacy of aprepitant in patients with subacute sclerosing panencephalitis.
METHODS


A randomized, double-blind, placebo-controlled study was conducted in patients with subacute sclerosing panencephalitis assigned to receive two courses of aprepitant 250 mg/day orally or placebo for 15 days with an interval of two months between courses. Primary end points were safety and tolerability, and secondary end point was clinical improvement or stabilization assessed by subacute sclerosing panencephalitis scoring system. Electroencephalography (EEG), brain magnetic resonance imaging, and cerebrospinal fluid measles-specific immunoglobulin G index were evaluated before and after treatment.
RESULTS


Sixty-two patients with subacute sclerosing panencephalitis were allocated to aprepitant (n = 31, median age 18 years) or placebo (n = 31, median age 22 years) group. Fifteen patients left the study within the first six months and 12 patients left between six and 12 months. Aprepitant was well tolerated and treatment-associated adverse events were similar to those described in the treatment of nausea. Clinical status at six and 12 months' follow-up did not differ between aprepitant and placebo groups. Post-treatment EEG scores at 12 months were better in the aprepitant group (P = 0.015). Cerebral atrophy on magnetic resonance imaging increased in both groups, whereas measles-specific immunoglobulin G index decreased in the placebo group.
CONCLUSIONS


In this first clinical trial of aprepitant treatment in patients with subacute sclerosing panencephalitis, the drug was safe and well tolerated. No clinical effect was observed. A modest improvement in EEG findings might justify trials for longer periods because EEG changes can precede clinical findings in subacute sclerosing panencephalitis.",2020,Post-treatment EEG scores at 12 months were better in the aprepitant group (P = 0.015).,"['Sixty-two patients with subacute sclerosing panencephalitis', 'patients with subacute sclerosing panencephalitis', 'Subacute Sclerosing Panencephalitis', 'Fifteen patients left the study within the first six\xa0months and 12 patients left between six and 12\xa0months']","['Placebo', 'aprepitant 250\xa0mg/day orally or placebo', 'placebo']","['Cerebral atrophy on magnetic resonance imaging', 'safety and efficacy', 'safety and tolerability, and secondary end point was clinical improvement or stabilization assessed by subacute sclerosing panencephalitis scoring system', 'measles-specific immunoglobulin G index', 'tolerated and treatment-associated adverse events', 'Electroencephalography (EEG), brain magnetic resonance imaging, and cerebrospinal fluid measles-specific immunoglobulin G index', 'nausea', 'safe and well tolerated']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038522', 'cui_str': 'Subacute sclerosing panencephalitis'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038522', 'cui_str': 'Subacute sclerosing panencephalitis'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",62.0,0.342205,Post-treatment EEG scores at 12 months were better in the aprepitant group (P = 0.015).,"[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Oncel', 'Affiliation': 'Department of Pediatric Neurology, Hacettepe University, Ankara, Turkey. Electronic address: dribrahimoncel@gmail.com.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Sancar', 'Affiliation': 'Faculty of Pharmacy, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Konuskan', 'Affiliation': 'Department of Pediatric Neurology, Hacettepe University, Ankara, Turkey; Pediatric Neurology Clinic, Ministry of Health Mardin Public Hospital, Mardin, Turkey.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Arioz', 'Affiliation': 'Analytic Chemistry, Istanbul, Turkey.'}, {'ForeName': 'Songul', 'Initials': 'S', 'LastName': 'Tezcan', 'Affiliation': 'Faculty of Pharmacy, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arman-Kandirmaz', 'Affiliation': 'School of Applied Disciplines, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Safak', 'Initials': 'S', 'LastName': 'Parlak', 'Affiliation': 'Department of Radiology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Ekim', 'Initials': 'E', 'LastName': 'Gumeler', 'Affiliation': 'Department of Radiology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Anlar', 'Affiliation': 'Department of Pediatric Neurology, Hacettepe University, Ankara, Turkey.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.05.009']
1650,32721411,School-based soccer practice is an effective strategy to improve cardiovascular and metabolic risk factors in overweight children.,"We examined the effects of a 6-month school-based soccer programme on cardiovascular (CV) and metabolic risk factors in overweight children. Methods: 40 boys [8-12 years; body mass index (BMI) >2 standard deviations of WHO reference values] participated in complementary school-based physical education classes (two sessions per week, 45-90 min each). The participants were divided into a soccer group (SG; n = 20) and a control group (CG; n = 20). The SG intervention involved 3 extra-curricular school-based soccer sessions per week, 60-90 min each. The intervention lasted for 6-months. All measurements were taken at baseline and after 6-months. From baseline to 6-months, the SG significantly improved (p < .05) BMI z-score, waist circumference, waist-to-height ratio, percentage of fat mass, percentage of fat-free mass, diastolic blood pressure, total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol, but no such improvements were observed for the CG. After the intervention, the prevalence of soccer participants with normal waist-to-height ratio (30 vs. 5%; p = .037), systolic blood pressure (90 vs. 55%; p = .039), total cholesterol (80 vs. 65%; p = .035) and LDL-C (90 vs. 75%; p = .012) were significantly higher than at baseline. The findings suggest that a 6-month school-based soccer intervention program represents an effective strategy to reduce CV and metabolic risk factors in overweight children prepared to take part in a soccer program.",2020,"From baseline to 6-months, the SG significantly improved (p < .05) BMI z-score, waist circumference, waist-to-height ratio, percentage of fat mass, percentage of fat-free mass, diastolic blood pressure, total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol, but no such improvements were observed for the CG.","['Methods: 40 boys [8-12\u202fyears; body mass index (BMI) >2 standard deviations of WHO reference values] participated in complementary school-based physical education classes (two sessions per week, 45-90\u202fmin each', 'overweight children']",['school-based soccer programme'],"['cardiovascular (CV) and metabolic risk factors', 'cardiovascular and metabolic risk factors', 'BMI z-score, waist circumference, waist-to-height ratio, percentage of fat mass, percentage of fat-free mass, diastolic blood pressure, total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol', 'total cholesterol', 'normal waist-to-height ratio', 'systolic blood pressure', 'CV and metabolic risk factors']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",3.0,0.0154865,"From baseline to 6-months, the SG significantly improved (p < .05) BMI z-score, waist circumference, waist-to-height ratio, percentage of fat mass, percentage of fat-free mass, diastolic blood pressure, total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol, but no such improvements were observed for the CG.","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Seabra', 'Affiliation': 'Portugal Football School, Portugal Football Federation, Portugal; Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Portugal. Electronic address: andre.seabra@fpf.pt.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Brito', 'Affiliation': 'Portugal Football School, Portugal Football Federation, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Figueiredo', 'Affiliation': 'Portugal Football School, Portugal Football Federation, Portugal; Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, University Institute of Maia, ISMAI, Portugal.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Beirão', 'Affiliation': 'Center of Research, Education, Innovation and Intervention in Sport (CIFI2D), Faculty of Sport, University of Porto, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Seabra', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Portugal.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Carvalho', 'Affiliation': 'Center of Research, Education, Innovation and Intervention in Sport (CIFI2D), Faculty of Sport, University of Porto, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Abreu', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Portugal.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Vale', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Portugal; School of Education, Polytechnic Institute of Porto, Portugal; Research and Innovation Centre in Education, School of Education, Polytechnic Institute of Porto, Portugal.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Pedretti', 'Affiliation': 'Research Group Projeto Esporte Brasil (PROESP-Br), School of Physical Education, Physical Therapy and Dance, Federal University of Rio Grande do Sul, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Nascimento', 'Affiliation': 'UCIBIO, REQUIMTE, Laboratory of Biochemistry, Department of Biological Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Belo', 'Affiliation': 'UCIBIO, REQUIMTE, Laboratory of Biochemistry, Department of Biological Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Rêgo', 'Affiliation': 'Center for Research in Health Technologies and Information Systems, Faculty of Medicine, University of Porto, Portugal.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.07.007']
1651,32723680,Same-day discharge after elective percutaneous coronary intervention: A single center experience.,"INTRODUCTION AND OBJECTIVES


Elective percutaneous coronary intervention (PCI) has become an increasingly safe procedure. However, same day discharge (SDD) has yet to become standard practice. Our aim is to characterize the patients who underwent elective PCI and compare outcomes between the overnight stay (ONS) patient group and the group that was discharged on the same day at 24 hours and at 30 days.
METHODS


One-year registry of patients who underwent an elective PCI. The possibility of SDD was established by the operator. Appropriate candidates were discharged at least four hours after the end of the intervention. The primary endpoints were defined as: Major adverse cardiac and cerebrovascular events (MACCE) - death, myocardial infarction (MI) stroke or transient ischemic attack (TIA), non-planned re-intervention - and vascular complications. Secondary endpoints were any unplanned hospital visit, readmission and re-catheterization.
RESULTS


We performed 155 elective PCIs. One patient was admitted to the coronary care unit; 111 patients stayed overnight (ONS Group); 43 patients were discharged the same day (SDD Group). Three patients had early (<4 hours) post procedure complications: two TIAs and one vascular access site complication. There were no MACCE between four and 24 hours, nor at 30 days. At 24 hours, two patients from the SDD group had unplanned visits. Between one and 30 days, more patients from the SDD group had unplanned visits (9.3% vs. 0.9%. p=0.02). One patient from the ONS group had a recatherization. There were no readmissions or reinterventions.
CONCLUSION


Same day discharge of selected patients who undergo elective PCIs is feasible and safe.",2020,"There were no readmissions or reinterventions.
","['One-year registry of patients who underwent an elective PCI', 'One patient was admitted to the coronary care unit; 111 patients stayed overnight (ONS Group); 43 patients were discharged the same day (SDD Group']",['Elective percutaneous coronary intervention (PCI'],"['unplanned hospital visit, readmission and', 'Major adverse cardiac and cerebrovascular events (MACCE) - death, myocardial infarction (MI) stroke or transient ischemic attack (TIA), non-planned re-intervention - and vascular complications', 'unplanned visits', 'readmissions or reinterventions']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",155.0,0.0488091,"There were no readmissions or reinterventions.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal. Electronic address: rodrigues.jal@gmail.com.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Almeida', 'Affiliation': 'Hospital do Divino Espírito Santo de Ponta Delgada, Ponta Delgada, Açores, Portugal.'}, {'ForeName': 'Francisco Castro', 'Initials': 'FC', 'LastName': 'Ferreira', 'Affiliation': 'Hospital da Senhora da Oliveira, Guimarães, Portugal.'}, {'ForeName': 'Gustavo Pires de', 'Initials': 'GP', 'LastName': 'Morais', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Santos', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Melica', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Braga', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}]",Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de Cardiologia = Portuguese journal of cardiology : an official journal of the Portuguese Society of Cardiology,['10.1016/j.repc.2019.10.008']
1652,32729838,Effects of the e-Motivate4Change Program on Metabolic Syndrome in Young Adults Using Health Apps and Wearable Devices: Quasi-Experimental Study.,"BACKGROUND


The health behaviors of young adults lag behind those of other age groups, and active health management is needed to improve health behaviors and prevent chronic diseases. In addition, developing good lifestyle habits earlier in life could reduce the risk of metabolic syndrome (MetS) later on.
OBJECTIVE


The aim of this study is to investigate the effects of the e-Motivate4Change program, for which health apps and wearable devices were selected based on user needs. The program was developed for the prevention and management of MetS in young adults.
METHODS


This experimental study used a nonequivalent control group. In total, 59 students from 2 universities in Daegu, Korea participated in the study (experimental group n=30; control group n=29). Data were collected over 4 months, from June 1 to September 30, 2018. The experimental group received a 12-week e-Motivate4Change program intervention, and the control group received MetS education and booklets without the e-Motivate4Change program intervention.
RESULTS


After the program, the experimental group had significantly higher scores for health-related lifestyle (t=3.86; P<.001) and self-efficacy (t=6.00; P<.001) than did the control group. Concerning BMI, there were significant effects by group (F=1.01; P<.001) and for the group × time interaction (F=4.71; P=.034). Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001).
CONCLUSIONS


The e-Motivate4Change program effectively improved participants' health-related lifestyle scores and self-efficacy, and significantly reduced their BMI and cholesterol levels. The program can be used to identify and prevent MetS among young adults.",2020,"Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001).
","['59 students from 2 universities in Daegu, Korea participated in the study (experimental group n=30; control group n=29', 'young adults', 'Young Adults Using Health Apps and Wearable Devices']","['e-Motivate4Change program', '12-week e-Motivate4Change program intervention, and the control group received MetS education and booklets without the e-Motivate4Change program intervention', 'e-Motivate4Change Program']","[""participants' health-related lifestyle scores and self-efficacy"", 'higher scores for health-related lifestyle', 'Metabolic Syndrome', 'self-efficacy', 'BMI and cholesterol levels']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",59.0,0.0179104,"Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001).
","[{'ForeName': 'Ji-Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Min-Ah', 'Initials': 'MA', 'LastName': 'Kang', 'Affiliation': 'Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Soo-Kyoung', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Keimyung University, Daegu, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/17031']
1653,32729843,Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and leads to frequent hospital admissions and emergency department (ED) visits. COPD exacerbations are an important patient outcome, and reducing their frequency would result in significant cost savings. Remote monitoring and self-monitoring could both help patients manage their symptoms and reduce the frequency of exacerbations, but they have different resource implications and have not been directly compared.
OBJECTIVE


This study aims to compare the effectiveness of implementing a technology-enabled self-monitoring program versus a technology-enabled remote monitoring program in patients with COPD compared with a standard care group.
METHODS


We conducted a 3-arm randomized controlled trial evaluating the effectiveness of a remote monitoring and a self-monitoring program relative to standard care. Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program. Patients in both interventions used a Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms, but only patients in the remote monitoring group were monitored by a respiratory therapist. All patients were assessed at baseline and at 3 and 6 months after program initiation. Outcomes included self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ). Patients were also asked to self-report on health system use, and data on health use were collected from the hospital.
RESULTS


A total of 122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups. Although all 3 groups improved in PIH scores, BCKQ scores, and SGRQ impact scores, there were no significant differences among any of the groups. No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.
CONCLUSIONS


Despite regular use of the technology, patients with COPD assigned to remote monitoring or self-monitoring did not have any improvement in patient outcomes such as self-management skills, knowledge, or symptoms, or in health care use compared with each other or with a standard care group. This may be owing to low health care use at baseline, the lack of structured educational components in the intervention groups, and the lack of integration of the action plan with the technology.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03741855; https://clinicaltrials.gov/ct2/show/ NCT03741855.",2020,"No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.
","['Chronic obstructive pulmonary disease (COPD', 'patients with COPD compared with a standard care group', 'Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program', '122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups', 'Chronic Obstructive Pulmonary Disease']","['technology-enabled self-monitoring program versus a technology-enabled remote monitoring program', 'remote monitoring and a self-monitoring program relative to standard care']","['PIH scores, BCKQ scores, and SGRQ impact scores', 'SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits', ""self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ"", 'Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms', 'COPD exacerbations']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}]",122.0,0.0434727,"No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.
","[{'ForeName': 'Vess', 'Initials': 'V', 'LastName': 'Stamenova', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Engel', 'Affiliation': 'Respiratory Therapy Department, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'van Lieshout', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lalingo', 'Affiliation': 'Medicine, Care Transitions, Access & Flow, Respiratory Therapy, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Cheung', 'Affiliation': 'Respiratory Therapy Department, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Erwood', 'Affiliation': 'Support Services & Transformation, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Radina', 'Affiliation': 'Center for Respiratory Health, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Greenwald', 'Affiliation': 'Center for Respiratory Health, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sidhu', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Shafai', 'Affiliation': 'Hospital to Home and Community Medicine Clinic, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Onil', 'Initials': 'O', 'LastName': 'Bhattacharyya', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}]",Journal of medical Internet research,['10.2196/18598']
1654,32735216,Perceived Effectiveness and Motivations for the Use of Web-Based Mental Health Programs: Qualitative Study.,"BACKGROUND


The prevalence of depression is high and has been stable despite increased treatment, research, and dissemination. People encounter barriers to seeking traditional mental health services, which could be mitigated by using web-based prevention methods.
OBJECTIVE


This study aims to understand what people at high risk for depression perceive as effective aspects of web-based mental health programs and what motivates people at high risk for depression to use web-based mental health programs.
METHODS


We conducted an inductive content analysis using telephone interview data from 77 participants at high risk for depression who were recruited from 2 randomized controlled trials (RCTs). Participants from the first RCT were working men who had been randomly assigned to 1 of the following 3 groups: control group, who had access to general depression information from a website called BroMatters; intervention group 1, who had access to the BroMatters website along with the associated BroHealth web-based mental health program; and intervention group 2, who had access to the BroMatters website, the BroHealth web-based mental health program, and telephone sessions with a life coach. Participants from the second RCT were men and women who had been assigned to the intervention group, who received access to the HardHat web-based mental health program, or the control group, who only received access to the HardHat web-based mental health program following completion of the RCT. Participants for this inductive content analysis study were recruited from the intervention groups in both RCTs. Two groups of participants (n=41 and n=20) were recruited from the BroHealth RCT, and a third group comprised 16 participants that were recruited from the HardHat RCT.
RESULTS


We generated four categories regarding the perceived effectiveness of web-based programs and five categories related to what motivates the use of web-based programs. Participants identified awareness, program medium and functionality, program content, and coaches as categories related to the effectiveness of the programs. Categories of motivators to use web-based programs included providing reminders or incentives, promotion of the programs, providing appropriate medium and functionality, appropriate content, and perceived need. The final category related to motivators reflects perceptions of participants who were either unsure about what motivates them or believed that there is no way to motivate use.
CONCLUSIONS


Conflicting evidence was obtained regarding the perceived effectiveness of aspects of the content and functionality of web-based programs. In general, web-based mental health programs were perceived to help increase mental health awareness, especially when it includes live access to a coach. However, the results also revealed that it is difficult to motivate people to begin using web-based mental health programs. Strategies that may motivate the use of such programs include perceived personal need, effective promotion, providing incentives and reminders, and improving functionality.",2020,"In general, web-based mental health programs were perceived to help increase mental health awareness, especially when it includes live access to a coach.","['Participants from the first RCT were working men who had been randomly assigned to 1 of the following 3 groups', 'Two groups of participants (n=41 and n=20) were recruited from the BroHealth RCT, and a third group comprised 16 participants that were recruited from the HardHat RCT', '77 participants at high risk for depression who were recruited from 2 randomized controlled trials (RCTs', 'Participants from the second RCT were men and women who had been assigned to the intervention group, who received']","['control group, who had access to general depression information from a website called BroMatters; intervention group 1, who had access to the BroMatters website along with the associated BroHealth web-based mental health program; and intervention group 2, who had access to the BroMatters website, the BroHealth web-based mental health program, and telephone sessions with a life coach', 'access to the HardHat web-based mental health program, or the control group, who only received access to the HardHat web-based mental health program following completion of the RCT']",[],"[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",[],77.0,0.075457,"In general, web-based mental health programs were perceived to help increase mental health awareness, especially when it includes live access to a coach.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Eccles', 'Affiliation': 'Work & Mental Health Research Unit, The Institute of Mental Health Research, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Nannarone', 'Affiliation': 'Work & Mental Health Research Unit, The Institute of Mental Health Research, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences,, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Attridge', 'Affiliation': 'Attridge Consulting, Inc, Minneapolis, MN, United States.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Marchand', 'Affiliation': 'School of Industrial Relations, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Aiken', 'Affiliation': 'Office of Research and Innovation, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Work & Mental Health Research Unit, The Institute of Mental Health Research, University of Ottawa, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/16961']
1655,32735218,Effects of an mHealth Brisk Walking Intervention on Increasing Physical Activity in Older People With Cognitive Frailty: Pilot Randomized Controlled Trial.,"BACKGROUND


Cognitive frailty is the coexistence of physical frailty and cognitive impairment and is an at-risk state for many adverse health outcomes. Moderate-to-vigorous physical activity (MVPA) is protective against the progression of cognitive frailty. Physical inactivity is common in older people, and brisk walking is a feasible form of physical activity that can enhance their MVPA. Mobile health (mHealth) employing persuasive technology has been successful in increasing the levels of physical activity in older people. However, its feasibility and effects on older people with cognitive frailty are unclear.
OBJECTIVE


We aimed to identify the issues related to the feasibility of an mHealth intervention and the trial (ie, recruitment, retention, participation, and compliance) and to examine the effects of the intervention on cognitive function, physical frailty, walking time, and MVPA.
METHODS


An open-label, parallel design, randomized controlled trial (RCT) was employed. The eligibility criteria for the participants were age ≥60 years, having cognitive frailty, and having physical inactivity. In the intervention group, participants received both conventional behavior change intervention and mHealth (ie, smartphone-assisted program using Samsung Health and WhatsApp) interventions. In the control group, participants received conventional behavior change intervention only. The outcomes included cognitive function, frailty, walking time, and MVPA. Permuted block randomization in 1:1 ratio was used. The feasibility issue was described in terms of participant recruitment, retention, participation, and compliance. Wilcoxon signed-rank test was used to test the within-group effects in both groups separately.
RESULTS


We recruited 99 participants; 33 eligible participants were randomized into either the intervention group (n=16) or the control (n=17) group. The median age was 71.0 years (IQR 9.0) and the majority of them were females (28/33, 85%). The recruitment rate was 33% (33/99), the participant retention rate was 91% (30/33), and the attendance rate of all the face-to-face sessions was 100% (33/33). The majority of the smartphone messages were read by the participants within 30 minutes (91/216, 42.1%). ActiGraph (58/66 days, 88%) and smartphone (54/56 days, 97%) wearing compliances were good. After the interventions, cognitive function improvement was significant in both the intervention (P=.003) and the control (P=.009) groups. The increase in frailty reduction (P=.005), walking time (P=.03), step count (P=.02), brisk walking time (P=.009), peak cadence (P=.003), and MVPA time (P=.02) were significant only in the intervention group.
CONCLUSIONS


Our mHealth intervention is feasible for implementation in older people with cognitive impairment and is effective at enhancing compliance with the brisk walking training program delivered by the conventional behavior change interventions. We provide preliminary evidence that this mHealth intervention can increase MVPA time to an extent sufficient to yield clinical benefits (ie, reduction in cognitive frailty). A full-powered and assessor-blinded RCT should be employed in the future to warrant these effects.
TRIAL REGISTRATION


HKU Clinical Trials Registry HKUCTR-2283; http://www.hkuctr.com/Study/Show/31df4708944944bd99e730d839db4756.",2020,"After the interventions, cognitive function improvement was significant in both the intervention (P=.003) and the control (P=.009) groups.","['older people with cognitive impairment', 'participants were age ≥60 years, having cognitive frailty, and having physical inactivity', 'older people with cognitive frailty', 'older people', '99 participants; 33 eligible participants', 'Older People']","['conventional behavior change intervention and mHealth (ie, smartphone-assisted program using Samsung Health and WhatsApp) interventions', 'conventional behavior change intervention', 'ActiGraph', 'mHealth intervention', 'Mobile health (mHealth) employing persuasive technology', 'mHealth Brisk Walking Intervention', 'Moderate-to-vigorous physical activity (MVPA']","['cognitive function, physical frailty, walking time, and MVPA', 'attendance rate', 'cognitive function improvement', 'frailty reduction', 'recruitment rate', 'participant retention rate', 'Physical Activity', 'walking time', 'brisk walking time', 'MVPA time', 'cognitive function, frailty, walking time, and MVPA', 'peak cadence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",33.0,0.0726845,"After the interventions, cognitive function improvement was significant in both the intervention (P=.003) and the control (P=.009) groups.","[{'ForeName': 'Rick Yc', 'Initials': 'RY', 'LastName': 'Kwan', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong (China).'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Daphne Sk', 'Initials': 'DS', 'LastName': 'Cheung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Ladda', 'Initials': 'L', 'LastName': 'Thiamwong', 'Affiliation': 'College of Nursing, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Kup-Sze', 'Initials': 'KS', 'LastName': 'Choi', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong (China).'}]",JMIR mHealth and uHealth,['10.2196/16596']
1656,32735221,Effectiveness of a Mobile App Intervention for Anxiety and Depression Symptoms in University Students: Randomized Controlled Trial.,"BACKGROUND


Depression and anxiety symptoms are common among university students, but many do not receive treatment. This is often because of lack of availability, reluctance to seek help, and not meeting the diagnostic criteria required to access services. Internet-based interventions, including smartphone apps, can overcome these issues. However, a large number of apps are available, each with little evidence of their effectiveness.
OBJECTIVE


This study aims to evaluate for the first time the effectiveness of a self-guided mobile app, Feel Stress Free, for the treatment of depression and anxiety symptoms in students.
METHODS


A web-based randomized controlled trial compared a cognitive behavioral therapy (CBT)-based mobile app Feel Stress Free with a wait-list control. University students self-identified as experiencing symptoms of anxiety or depression and were randomized to 6 weeks of intervention (n=84) or control (n=84), unblinded. The app is self-guided and incorporates behavioral relaxation activities, mood tracking and thought challenging, and minigames. Participants completed the Hospital Anxiety and Depression Scale online at baseline and every fortnight.
RESULTS


At week 6, the primary end point, there was evidence that the Feel Stress Free app reduced depression symptoms (mean difference -1.56; 95% CI -2.67 to -0.44; P=.006) but only very weak evidence that it reduced anxiety symptoms (mean difference -1.36; 95% CI -2.93 to 0.21; P=.09). At week 4, there was evidence to support the effectiveness of the intervention for anxiety symptoms (mean difference -1.94; 95% CI -3.11 to -0.77; P=.001) and, though weaker, depression symptoms (mean difference -1.08; 95% CI -2.12 to -0.04; P=.04). At week 6, 83% (34/41) of participants indicated that they were using the app weekly or more frequently.
CONCLUSIONS


The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT. Further research is needed to establish its effectiveness at and beyond 6 weeks.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03032952; https://clinicaltrials.gov/ct2/show/NCT03032952.",2020,The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT.,"['depression and anxiety symptoms in students', 'University students self-identified as experiencing symptoms of anxiety or depression', 'University Students', 'university students']","['Mobile App Intervention', 'cognitive behavioral therapy (CBT)-based mobile app Feel Stress Free with a wait-list control']","['anxiety symptoms', 'Hospital Anxiety and Depression Scale online', 'Feel Stress Free app reduced depression symptoms', 'Anxiety and Depression Symptoms', 'depression symptoms']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.247771,The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT.,"[{'ForeName': 'Tayla', 'Initials': 'T', 'LastName': 'McCloud', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Vaughan', 'Initials': 'V', 'LastName': 'Bell', 'Affiliation': 'Division of Psychology & Language Sciences, University College London, London, United Kingdom.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Tsakanikos', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}]",JMIR mHealth and uHealth,['10.2196/15418']
1657,32735225,Use of a Smartphone App for Weight Loss Versus a Paper-Based Dietary Diary in Overweight Adults: Randomized Controlled Trial.,"BACKGROUND


Mobile health (mHealth) tools may be useful platforms for dietary monitoring and assessment.
OBJECTIVE


This study aims to evaluate the effectiveness of a mobile dietary self-monitoring app for weight loss versus a paper-based diary among adults with a BMI of 23 kg/m 2  or above.
METHODS


A total of 33 men and 17 women aged 18-39 years participated in a 6-week randomized controlled trial. We randomly assigned participants to one of two groups: (1) a smartphone app group (n=25) or (2) a paper-based diary group (n=25). The smartphone app group recorded foods and dietary supplements that they consumed and received immediate dietary feedback using Well-D, a dietary self-monitoring app developed by our team. The paper-based diary group was instructed to record foods or supplements that they consumed using a self-recorded diary. The primary outcomes were weight, BMI, waist circumference, body fat mass, and skeletal muscle mass. We also examined changes in nutrient intake, including energy, carbohydrate, protein, fat, dietary fiber, vitamins, and minerals, using 3-day 24-hour recalls. Differences in changes between the two groups were analyzed using independent t tests or Wilcoxon Mann-Whitney tests. All of the data were analyzed using intent-to-treat analysis.
RESULTS


The mean number of days recorded was 18.5 (SD 14.1) for the app group and 15.5 (SD 10.1) for the paper-based diary group. The differences in changes in weight, BMI, and waist circumference were not significantly different between the app group and paper-based diary group (P=.33, .34, and .70, respectively). Similarly, changes in body fat mass or skeletal muscle mass did not differ between the two groups (P=.71 and .054, respectively). Although energy intake was reduced in both groups, there was no significant difference in changes in energy intake between the two groups (P=.98).
CONCLUSIONS


There were no differences in changes in anthropometric measures and nutrient intake between the app group and the paper-based diary group. Both mobile dietary self-monitoring app and paper-based diary may be useful for improving anthropometric measures.
TRIAL REGISTRATION


Clinical Research Information Service KCT0003170; https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=11642&ltype=&rtype=.",2020,There were no differences in changes in anthropometric measures and nutrient intake between the app group and the paper-based diary group.,"['Overweight Adults', '33 men and 17 women aged 18-39 years', 'adults with a BMI of 23 kg/m 2  or above']","['smartphone app group (n=25) or (2) a paper-based diary group', 'Smartphone App', 'smartphone app group recorded foods and dietary supplements that they consumed and received immediate dietary feedback using Well-D, a dietary self-monitoring app developed by our team', 'mobile dietary self-monitoring app']","['weight, BMI, waist circumference, body fat mass, and skeletal muscle mass', 'weight, BMI, and waist circumference', 'Weight Loss', 'nutrient intake, including energy, carbohydrate, protein, fat, dietary fiber, vitamins, and minerals, using 3-day 24-hour recalls', 'anthropometric measures and nutrient intake', 'body fat mass or skeletal muscle mass', 'weight loss', 'mean number of days recorded', 'energy intake']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]",33.0,0.148849,There were no differences in changes in anthropometric measures and nutrient intake between the app group and the paper-based diary group.,"[{'ForeName': 'Jeong Sun', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Heejin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Jiae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Platform Development Team, Bluecore, Seoul, Republic of Korea.'}, {'ForeName': 'Haemin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Platform Development Team, Bluecore, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Woo', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Home Economics, Korea National Open University, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/14013']
1658,32735987,"A two-site, open-label, non-randomized trial comparing Focal Electrically-Administered Seizure Therapy (FEAST) and right unilateral ultrabrief pulse electroconvulsive therapy (RUL-UBP ECT).","BACKGROUND


Focal Electrically-Administered Seizure Therapy (FEAST) is a form of electroconvulsive therapy (ECT) that spatially focuses the electrical stimulus to initiate seizure activity in right prefrontal cortex. Two open-label non-comparative studies suggested that FEAST has reduced cognitive side effects when compared to historical data from other forms of ECT. In two different ECT clinics, we compared the efficacy and cognitive side effects of FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT.
METHODS


Using a non-randomized, open-label design, 39 depressed adults were recruited after referral for ECT. Twenty patients received FEAST (14 women; age 45.2 ± 12.7), and 19 received RUL-UBP ECT (16 women; age 43.2 ± 16.4). Key cognitive outcome measures were the postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF). Antidepressant effects were assessed using the Hamilton Rating Scale for Depression (HRSD 24 ).
RESULTS


In the Intent-to-treat sample, a repeated measures mixed model suggested no between group difference in HRSD 24  score over time (F 1,35  = 0.82, p = 0.37), while the response rate favored FEAST (FEAST: 65%; RUL-UBP ECT: 57.9%), and the remission rate favored RUL-UBP ECT (FEAST: 35%; RUL-UBP ECT: 47.4%). The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6 ± 5.0 min; RUL-UBP ECT: 8.8 ± 5.8 min; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2 ± 14.2%; RUL-UBP ECT: 63.9 ± 9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
CONCLUSIONS


FEAST exerts similar efficacy relative to an optimal form of conventional ECT and may have milder cognitive side effects. A blinded, randomized, non-inferiority trial is needed.",2020,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","['Twenty patients received FEAST (14 women; age 45.2±12.7), and 19 received', '39 depressed adults were recruited after referral for ECT']","['electroconvulsive therapy (ECT', 'FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT', 'Focal Electrically-Administered Seizure Therapy (FEAST) and Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy (RUL-UBP ECT', 'RUL-UBP ECT', 'FEAST', 'Focal Electrically-Administered Seizure Therapy (FEAST']","['cognitive side effects', 'CUAMI-SF consistency score', 'efficacy and cognitive side effects', 'postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF', 'Hamilton Rating Scale for Depression (HRSD 24 ', 'numeric superiority', 'Antidepressant effects', 'HRSD 24  score over time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0451013', 'cui_str': 'Autobiographical memory interview'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",39.0,0.0739028,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Sahlem', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA. Electronic address: sahlem@musc.edu.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'E Baron', 'Initials': 'EB', 'LastName': 'Short', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fox', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Manett', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Kerns', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Dancy', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA; Ralph H. Johnson VA Medical Center, SC, USA.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.015']
1659,32736036,"Bouncing back after lumbar spine surgery: early postoperative resilience is associated with 12-month physical function, pain interference, social participation, and disability.","BACKGROUND CONTEXT


Positive psychosocial factors early after surgery, such as resilience and self-efficacy, may be important characteristics for informing individualized postoperative care.
PURPOSE


To examine the association of early postoperative resilience and self-efficacy on 12-month physical function, pain interference, social participation, disability, pain intensity, and physical activity after lumbar spine surgery.
STUDY DESIGN/SETTING


Pooled secondary analysis of prospectively collected trial data from two academic medical centers.
PATIENT SAMPLE


Two hundred and forty-eight patients who underwent laminectomy with or without fusion for a degenerative lumbar condition.
OUTCOME MEASURES


Physical function, pain inference, and social participation (ability to participate in social roles and activities) were measured using the Patient Reported Outcomes Measurement Information System. The Oswestry Disability Index, Numeric Rating Scale, and accelerometer activity counts were used to measure disability, pain intensity, and physical activity, respectively.
METHODS


Participants completed validated outcome questionnaires at 6 weeks (baseline) and 12 months after surgery. Baseline positive psychosocial factors included resilience (Brief Resilience Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). Multivariable linear regression analyses were used to assess the associations between early postoperative psychosocial factors and 12-month outcomes adjusting for age, sex, study site, randomized group, fusion status, fear of movement (Tampa Scale for Kinesiophobia), and outcome score at baseline. This study was funded by Patient-Centered Outcomes Research Institute and Foundation for Physical Therapy Research. There are no conflicts of interest.
RESULTS


Resilience at 6 weeks after surgery was associated with 12-month physical function (unstandardized beta=1.85 [95% confidence interval [CI]: 0.29; 3.40]), pain interference (unstandardized beta=-1.80 [95% CI: -3.48; -0.12]), social participation (unstandardized beta=2.69 [95% CI: 0.97; 4.41]), and disability (unstandardized beta=-3.03 [95% CI: -6.04; -0.02]). Self-efficacy was associated with 12-month disability (unstandardized beta=-0.21 [95% CI: -0.37; -0.04].
CONCLUSIONS


Postoperative resilience and pain self-efficacy were associated with improved 12-month patient-reported outcomes after spine surgery. Future work should consider how early postoperative screening for positive psychosocial characteristics can enhance risk stratification and targeted rehabilitation management in patients undergoing spine surgery.",2020,Self-efficacy was associated with 12-month disability (unstandardized beta = -0.21 [95% CI: -0.37;,"['Participants completed validated outcome questionnaires at 6 weeks (baseline) and 12 months after surgery', 'Bouncing Back after Lumbar Spine Surgery', 'patients undergoing spine surgery', 'SAMPLE\n\n\n248 patients who underwent laminectomy with or without fusion for a degenerative lumbar condition']",[],"['disability (unstandardized beta', '12-month disability', '12-Month Physical Function, Pain Interference, Social Participation, and Disability', '12-month physical function, pain interference, social participation, disability, pain intensity, and physical activity', 'Oswestry Disability Index, Numeric Rating Scale, and accelerometer activity counts', 'social participation', '12-month physical function', 'disability, pain intensity, and physical activity, respectively', 'fusion status, fear of movement (Tampa Scale of Kinesiophobia), and outcome score', 'Postoperative resilience and pain self-efficacy', 'pain interference', 'Physical function, pain inference, and social participation (ability to participate in social roles and activities', 'Baseline positive psychosocial factors included resilience (Brief Resilience Scale) and self-efficacy (Pain Self-Efficacy Questionnaire', 'Self-efficacy']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}]",248.0,0.07827,Self-efficacy was associated with 12-month disability (unstandardized beta = -0.21 [95% CI: -0.37;,"[{'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East-South Tower, Suite 4200, Nashville, TN 37232, USA.'}, {'ForeName': 'Payton E', 'Initials': 'PE', 'LastName': 'Robinette', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East-South Tower, Suite 4200, Nashville, TN 37232, USA.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East-South Tower, Suite 4200, Nashville, TN 37232, USA.'}, {'ForeName': 'Jacquelyn S', 'Initials': 'JS', 'LastName': 'Pennings', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East-South Tower, Suite 4200, Nashville, TN 37232, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Haug', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East-South Tower, Suite 4200, Nashville, TN 37232, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Skolasky', 'Affiliation': 'Department of Orthopaedic Surgery, Johns Hopkins University, 601 N. Caroline St, Baltimore, MD 21287, USA.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Riley', 'Affiliation': 'Department of Orthopaedic Surgery, Johns Hopkins University, 601 N. Caroline St, Baltimore, MD 21287, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Neuman', 'Affiliation': 'Department of Orthopaedic Surgery, Johns Hopkins University, 601 N. Caroline St, Baltimore, MD 21287, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurological Surgery, University of Cincinnati College of Medicine, 222 Piedmont Ave, Suite 2200, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Oran S', 'Initials': 'OS', 'LastName': 'Aaronson', 'Affiliation': 'Howell Allen Clinic, Saint Thomas Medical Partners, 2011 Murphy Ave, Suite 301, Nashville, TN 37203, USA.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Devin', 'Affiliation': 'Steamboat Orthopaedic and Spine Institute, 904 Central Park Drive, Suite 280, Steamboat Springs, CO 80487, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University, 601 N. Caroline St, Baltimore, MD 21287, USA.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East-South Tower, Suite 4200, Nashville, TN 37232, USA. Electronic address: kristin.archer@vumc.org.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.07.013']
1660,32781112,Maintenance of muscle strength following a one-year resistance training program in older adults.,"BACKGROUND


Muscle mass, strength and function declines with advancing age. Strength training (ST) improves these parameters in older adults, but the gains often disappear after completion of a short-term intervention. The purpose of the present study was to investigate muscle mass, -strength and -function one year after the completion of a successful long-term (12 months) supervised ST program in older adults.
METHOD


Men and women (n = 419, age: 62-70 years) completed one year of supervised heavy resistance training (HRT, n = 143) or moderate intensity resistance training (MIT, n = 144) and were compared to a non-exercising control group (CON, n = 132). At 1-year follow-up, 398 participants returned for measurements of muscle power, -strength and -mass, physical function, body composition, hippocampus volume and physical/mental well-being. The results were compared to pre-training (baseline) and post-training (1-year) values. Further, the participants from the two previous training groups (HRT + MIT, n = 265) were divided into 1) those who on their own continued the ST program (>9 months) the year after completion of the supervised ST program (CONTIN, n = 65) and 2) those who stopped during the follow-up year (<9 months) (STOP, n = 200).
RESULTS


Out of all the improvements obtained after the 1-year training intervention, only knee extensor muscle strength in HRT was preserved at 1-year follow-up (p < 0.0001), where muscle strength was 7% higher than baseline. Additionally, the decrease in muscle strength over the second year was lower in CONTIN than in STOP with decreases of 1% and 6%, respectively (p < 0.05). Only in CONTIN was the muscle strength still higher at 1-year follow-up compared with baseline with a 14% increase (p < 0.0001). The heavy strength training induced increase in whole-body lean mass was erased at 1-year follow-up. However, there was a tendency for maintenance of the cross-sectional area of m. vastus lateralis from baseline to 1-year follow-up in HRT compared with CON (p = 0.06). Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
CONCLUSION


Even though long-term strength training effectively improved muscle function and other health parameters in older adults, only knee extensor muscle strength was preserved one year after completion of heavy (but not moderate intensity) resistance training. Continuation of strength training resulted in better maintenance of muscle strength and health, which indicates that it is required to continue with physical activity to benefit from the long-term effects of strength training upon muscle function and health in older men and women.",2020,"Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
","['older adults', 'Men and women (n\u202f=\u202f419, age: 62-70\u202fyears) completed one year of', 'older men and women']","['Strength training (ST', 'training intervention', 'supervised heavy resistance training (HRT, n\u202f=\u202f143) or moderate intensity resistance training (MIT, n\u202f=\u202f144) and were compared to a non-exercising control', 'heavy strength training', 'strength training', 'successful long-term (12\u202fmonths) supervised ST program']","['knee extensor muscle strength', 'knee extensor muscle strength in HRT', 'Waist circumference', 'muscle function and other health parameters', 'muscle strength still higher', 'muscle power, -strength and -mass, physical function, body composition, hippocampus volume and physical/mental well-being', 'muscle strength', 'whole-body lean mass']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",265.0,0.0132112,"Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
","[{'ForeName': 'Anne Theil', 'Initials': 'AT', 'LastName': 'Gylling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark. Electronic address: anne.theil.gylling@regionh.dk.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bloch-Ibenfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Christian Skou', 'Initials': 'CS', 'LastName': 'Eriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Andreas Kraag', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Cathrine Lawaetz', 'Initials': 'CL', 'LastName': 'Wimmelmann', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baekgaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Danish Research Center for Magnetic Resonance, Center for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, 2650 Hvidovre, Denmark; Department of Radiation Sciences, Umeå University, S-901 87 Umeå, Sweden.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Center for Magnetic Resonance, Center for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, 2650 Hvidovre, Denmark; Department of Neurology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2020.111049']
1661,32781256,A comparative evaluation of iliac crest bone graft with and without injectable and advanced platelet rich fibrin in secondary alveolar bone grafting for cleft alveolus in unilateral cleft lip and palate patients: A randomized prospective study.,"PURPOSE


Platelet rich fibrin enhances bone healing and results in better graft intake and helps in faster periodontal healing. In this study we have used a combination of two newly developed forms of platelet rich fibrin: injectable and advanced along with iliac bone graft for secondary alveolar bone grafting and compared it with cases in which only iliac bone graft was used.
METHODS


30 patients with alveolar cleft, with age group of ≥7 years, having complete unilateral cleft alveolus were included and divided into 2 groups of 15 patients each randomly. In Group A, secondary alveolar bone grafting was done using iliac bone graft along with injectable and advanced palate rich fibrin and in Group B, secondary alveolar bone grafting was done only with iliac bone graft. Success of the treatment was assessed using radiographic and clinical methods which included: The bone resorption of the interalveolar septum height of the teeth adjacent to the cleft, evaluated as per Bergland classification, assessment of periodontal status of the teeth adjacent to cleft alveolus.
RESULTS


After 3 months and 6 months postoperatively: study group had better overall scores as per Bergland criteria. Periodontal status improved in both groups but was more in study group compared to control group. For both evaluations the data was clinically favorable in the study group.
CONCLUSION


On preliminary investigations it shows that combination of injectable and advanced platelet rich fibrin seems to enhance bone formation in alveolar clefts when admixed with autologous cancellous bone harvested from the iliac crest than using iliac bone graft alone. It also reduces the chances of bone resorption and show higher percentage of bone volume. Secondary alveolar grafting improves periodontal health around the cleft alveolus.",2020,Periodontal status improved in both groups but was more in study group compared to control group.,"['30 patients with alveolar cleft, with age group of ≥ 7 years, having complete unilateral cleft alveolus were included and divided into 2 groups of 15 patients each randomly']","['OF ILIAC CREST BONE', 'Secondary alveolar grafting', 'secondary alveolar bone grafting was done using iliac bone graft along with injectable and advanced palate rich fibrin and in Group B, secondary alveolar bone grafting was done only with iliac bone graft']","['Periodontal status', 'chances of bone resorption', 'bone resorption of the interalveolar septum height', 'periodontal health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0432084', 'cui_str': 'Cleft of primary palate'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0227130', 'cui_str': 'Structure of alveolus dentalis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0407708', 'cui_str': 'Alveolar bone graft'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0752060', 'cui_str': 'Septum of Brain'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",30.0,0.0356828,Periodontal status improved in both groups but was more in study group compared to control group.,"[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Dayashankara Rao', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, Qassim University, Buraida, Al Qassim Region, Saudi Arabia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India. Electronic address: rajeevpandeyleo@gmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Arya', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Arora', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bootwala', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}, {'ForeName': 'W N', 'Initials': 'WN', 'LastName': 'Devi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, SGT University, Gurugram, India.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.07.007']
1662,32781939,Electroanalgesia during a carboxytherapy procedure for cellulite: a study protocol for a randomized controlled trial.,"The aim of the present study is to describe a study protocol to compare different types of analgesic electrical currents on pain intensity and sensory comfort during the application of carboxytherapy for the treatment of cellulite. Seventy five women with the presence of moderate and/or severe gluteal cellulite will be randomly allocated into three groups: carboxytherapy plus transcutaneous electrical nerve stimulation, carboxytherapy plus interferential current or carboxytherapy plus Aussie current. Pain intensity, which is the primary outcome, will be measured by a numeric rating scale (0-10). The secondary outcome is sensory comfort, which will be measured using the visual analogue scale (0-10). Trial registration: Brazilian Clinical Trials Registry: ReBEC (RBR-6z82zb) www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/.",2020,www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/.,"['five women with the presence of moderate and/or severe gluteal cellulite', 'Seventy']","['analgesic electrical currents', 'carboxytherapy', 'Electroanalgesia', 'carboxytherapy plus transcutaneous electrical nerve stimulation, carboxytherapy plus interferential current\xa0or carboxytherapy plus Aussie current', 'ReBEC (RBR-6z82zb', 'www.ensaiosclinicos.gov.br/rg/RBR-6z82zb']","['pain intensity and sensory comfort', 'Pain intensity', 'sensory comfort, which will be measured using the visual analogue scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1522015', 'cui_str': 'Electroanalgesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",75.0,0.126507,www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/.,"[{'ForeName': 'Adria Yared', 'Initials': 'AY', 'LastName': 'Sadala', 'Affiliation': 'Physioterapeutics Resources Laboratory, Department of Physical Therapy, Federal University of São Carlos (UFSCar), Rod. Washington Luis, km 235, São Carlos/SP, Brazil.'}, {'ForeName': 'Érika Patrícia', 'Initials': 'ÉP', 'LastName': 'Rampazo da Silva', 'Affiliation': 'Physioterapeutics Resources Laboratory, Department of Physical Therapy, Federal University of São Carlos (UFSCar), Rod. Washington Luis, km 235, São Carlos/SP, Brazil.'}, {'ForeName': 'Richard Eloin', 'Initials': 'RE', 'LastName': 'Liebano', 'Affiliation': 'Physioterapeutics Resources Laboratory, Department of Physical Therapy, Federal University of São Carlos (UFSCar), Rod. Washington Luis, km 235, São Carlos/SP, Brazil.'}]",Pain management,['10.2217/pmt-2020-0003']
1663,32788051,Lack of effect on ambulation of dalfampridine-ER (4-AP) treatment in adult SMA patients.,"SMA is a genetically determined motor system disorder that results in muscle weakness, selective motor neuron death, muscle atrophy, and impaired functional mobility. In SMA model systems, long-term treatment with 4-aminopyridine (4-AP) has been shown to improve motor function. To assess tolerability and preliminary efficacy of 4-AP on walking ability, endurance and EMG in adult ambulatory SMA patients, we conducted a double blind, placebo control, crossover pilot study with dalfampridine (4-AP, 10 mg BID). The study is comprised of a short-term (2 weeks) treatment arm with 1-week washout and a long-term (6 weeks) treatment arm with a 2-week washout. The primary outcome measure, for which the study was powered, was the 6 min walk test (6MWT, distance and percent fatigue); secondary outcome measures were the Hammersmith Functional Motor Scale Expanded (HFMSE), Manual Muscle Testing (MMT), Myometry with Hand held Dynamometry, HHD) and Quantitative Gait Analyses. We performed electrophysiology, including CMAP and H-reflex, during the short-term treatment trial. The mean age of the 11 participants enrolled was 37.7 ± 11.9 years; 54.5% were male. Dalfampridine was safe and well tolerated and no patient suffered a serious adverse event related to treatment. We observed no statistically significant positive effects of dalfampridine treatment on our primary functional motor outcome (6MWT distance, fatigue). Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude. The effect on the H-reflex is of interest, as it suggests dalfampridine may enhance neuronal activity, an effect observed in SMA Drosophila and mouse models at doses (mg/kg) not recommended for clinical use. Larger studies with dalfampridine in SMA patients are needed to confirm our findings, especially in light of studies in other populations showing drug effects in only a subset of patients.",2020,Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude.,"['The mean age of the 11 participants enrolled was 37.7\u202f±\u202f11.9 years; 54.5% were male', 'SMA patients', 'adult ambulatory SMA patients', 'adult SMA patients']","['SMA', '4-AP', 'Dalfampridine', 'dalfampridine (4-AP, 10\u202fmg BID', '4-aminopyridine (4-AP', 'dalfampridine', 'dalfampridine-ER (4-AP', 'placebo']","['functional motor outcome (6MWT distance, fatigue', '6\xa0min walk test (6MWT, distance and percent fatigue', 'walking ability, endurance and EMG', 'H-reflex and H/M ratio', 'Hammersmith Functional Motor Scale Expanded (HFMSE), Manual Muscle Testing (MMT), Myometry with Hand held Dynamometry, HHD) and Quantitative Gait Analyses', 'safe and well tolerated']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0335933', 'cui_str': 'Hammersmith'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0085106', 'cui_str': 'Familial benign pemphigus'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]",11.0,0.104935,Dalfampridine had a positive effects on H-reflex and H/M ratio but not on CMAP amplitude.,"[{'ForeName': 'Claudia A', 'Initials': 'CA', 'LastName': 'Chiriboga', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States. Electronic address: cac3@cumc.columbia.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marra', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'LaMarca', 'Affiliation': 'Division of Child Neurology, Department of Neurology, Columbia College of Physicians and Surgeons, Columbia University Medical Center, 180 Fort Washington Avenue # 552, New York, NY 10032-3791, United States.'}, {'ForeName': 'Sally Dunaway', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'Department of Neurology, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Louis H', 'Initials': 'LH', 'LastName': 'Weimer', 'Affiliation': 'Department of Neurology, Columbia College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McCabe', 'Affiliation': 'Brain Mind Institute, EPFL, Lausanne, Switzerland.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.07.007']
1664,32788190,Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.,"INTRODUCTION


Human papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.
METHODS AND ANALYSIS


The TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.
ETHICS AND DISSEMINATION


The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l'Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.
TRIAL REGISTRATION NUMBER


NCT01824537.",2020,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","['heterosexual couples living in Montreal, Canada', 'sexual partners of vaccinated individuals', 'heterosexual couples', 'Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible']","['HPV vaccination (TRAP-HPV', 'intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo', 'HPV vaccination', 'HPV vaccine']",['transmission of genital and oral HPV infection'],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C3864947', 'cui_str': 'Gardasil 9'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}]",,0.257928,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'MacCosham', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'El-Zein', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ann N', 'Initials': 'AN', 'LastName': 'Burchell', 'Affiliation': ""Department of Family and Community Medicine and Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Tellier', 'Affiliation': 'Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Coutlée', 'Affiliation': ""Service de Microbiologie Médicale et Service d'Infectiologie, Départements de Médecine et de Médecine de Laboratoire, Centre Hospitalier de L'Universite de Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada eduardo.franco@mcgill.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039383']
1665,32711800,"Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial.","BACKGROUND


Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention.
METHODS


This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and tenofovir alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02842086, and is no longer recruiting.
FINDINGS


Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and tenofovir alafenamide was non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19-1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and tenofovir alafenamide group (0·16 infections per 100 person-years [95% CI 0·06-0·33]), and 15 participants in the emtricitabine and tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19-0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and tenofovir alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and tenofovir disoproxil fumarate group). Emtricitabine and tenofovir alafenamide was superior to emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints.
INTERPRETATION


Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.
FUNDING


Gilead Sciences.",2020,"Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.
","['group (0·34 infections per 100 person-years [0·19-0·56', 'Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants', 'enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections', 'After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the', '94 community, public health, and hospital-associated clinics located in regions of Europe and North America', '15 participants in the', 'Participants with current or previous use of PrEP with', 'HIV pre-exposure prophylaxis (DISCOVER', 'group (0·16 infections per 100 person-years']","['Tenofovir alafenamide', 'tenofovir alafenamide', 'emtricitabine', 'emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate', 'emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate', 'emtricitabine and tenofovir alafenamide', 'placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate', 'Emtricitabine and tenofovir alafenamide', 'placebo tablets (emtricitabine and tenofovir disoproxil fumarate group', 'Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate', 'pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate', 'emtricitabine and tenofovir disoproxil fumarate']","['bone mineral density and biomarkers of renal safety', 'incident HIV infection', 'antiviral efficacy and improved renal and bone safety', 'efficacy and safety', 'bone mineral density and renal biomarker safety endpoints', 'HIV incidence rate ratio (IRR']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",22.0,0.592697,"Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.
","[{'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'The Fenway Institute, Fenway Health, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Infectious Diseases Department, Hopitaux Saint-Louis Lariboisière, University of Paris and INSERM U944, Paris, France.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Karam C', 'Initials': 'KC', 'LastName': 'Mounzer', 'Affiliation': 'Philadelphia FIGHT, Philadelphia, PA, USA.'}, {'ForeName': 'Joss J', 'Initials': 'JJ', 'LastName': 'De Wet', 'Affiliation': 'Spectrum Health, Vancouver, BC, Canada.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Jessen', 'Affiliation': 'Praxis Jessen(2)\u2008+\u2008Kollegen, Berlin, Germany.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Grant', 'Affiliation': 'San Francisco AIDS Foundation, and University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ruane', 'Affiliation': 'Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathias', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Callebaut', 'Affiliation': 'Department of Virology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Moupali', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA. Electronic address: moupali.as@gilead.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McCallister', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV and Emerging Viral Infections Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Royal Sussex County Hospital, Brighton and Sussex University Hospitals National Health Service (NHS) Trust, Brighton, UK.'}, {'ForeName': 'Pep', 'Initials': 'P', 'LastName': 'Coll', 'Affiliation': 'BCN Checkpoint and IrsiCaixa-AIDS Research Institute, Barcelona, Spain.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Post', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's College Hospital, London, UK.""}, {'ForeName': 'C Bradley', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31065-5']
1666,32711801,"Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Abrocitinib, an oral selective Janus kinase 1 inhibitor, was effective and well tolerated in adults with moderate-to-severe atopic dermatitis in a phase 2b trial. We aimed to assess the efficacy and safety of abrocitinib monotherapy in adolescents and adults with moderate-to-severe atopic dermatitis.
METHODS


In this multicentre, double-blind, randomised phase 3 trial (JADE MONO-1), patients (aged ≥12 years) with moderate-to-severe atopic dermatitis (Investigator Global Assessment score ≥3, Eczema Area and Severity Index [EASI] score ≥16, percentage of body surface area affected ≥10%, and Peak Pruritus Numerical Rating Scale score ≥4) with a bodyweight of 40 kg or more, were enrolled at 69 sites in Australia, Canada, Europe, and the USA. Patients were randomly assigned (2:2:1) to oral abrocitinib 100 mg, abrocitinib 200 mg, or placebo once daily for 12 weeks. Randomisation was done using an interactive response technology system, stratified by baseline disease severity and age. Patients, investigators, and the funder of the study were masked to study treatment. The coprimary endpoints were the proportion of patients who had achieved an Investigator Global Assessment response (score of 0 [clear] or 1 [almost clear] with a ≥2-grade improvement from baseline), and the proportion of patients who achieved at least a 75% improvement in EASI score from baseline (EASI-75) score, both assessed at week 12. Efficacy was assessed in the full analysis set, which included all randomised patients who received at least one dose of study medication. Safety was assessed in all randomised patients. This study is registered with ClinicalTrials.gov, NCT03349060.
FINDINGS


Between Dec 7, 2017, and March 26, 2019, 387 patients were enrolled: 156 were assigned to abrocitinib 100 mg, 154 to abrocitinib 200 mg, and 77 to placebo. All enrolled patients received at least one dose of study treatment and thus were evaluable for 12-week efficacy. Of the patients with available data for the coprimary endpoints at week 12, the proportion of patients who had achieved an Investigator Global Assessment response was significantly higher in the abrocitinib 100 mg group than in the placebo group (37 [24%] of 156 patients vs six [8%] of 76 patients; p=0·0037) and in the abrocitinib 200 mg group compared with the placebo group (67 [44%] of 153 patients vs six [8%] of 76 patients; p<0·0001). Of the patients with available data for the coprimary endpoints at week 12, compared with the placebo group, the proportion of patients who had achieved an EASI-75 response was significantly higher in the abrocitinib 100 mg group (62 [40%] of 156 patients vs nine [12%] of 76 patients; p<0·0001) and abrocitinib 200 mg group (96 [63%] of 153 patients vs nine [12%] of 76 patients; p<0·0001). Adverse events were reported in 108 (69%) of 156 patients in the abrocitinib 100 mg group, 120 (78%) of 154 patients in the abrocitinib 200 mg group, and 44 (57%) of 77 patients in the placebo group. Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group. No treatment-related deaths were reported.
INTERPRETATION


Monotherapy with oral abrocitinib once daily was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis.
FUNDING


Pfizer.",2020,"Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group.","['adolescents and adults with moderate-to-severe atopic dermatitis', 'patients (aged ≥12 years) with moderate-to-severe atopic dermatitis (Investigator Global Assessment score ≥3, Eczema Area and Severity Index [EASI] score ≥16, percentage of body surface area affected ≥10%, and Peak Pruritus Numerical Rating Scale score ≥4) with a bodyweight of 40 kg or more, were enrolled at 69 sites in Australia, Canada, Europe, and the USA', '387 patients were enrolled: 156', 'adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1', 'adults with moderate-to-severe atopic dermatitis', 'Between Dec 7, 2017, and March 26, 2019']","['abrocitinib 100 mg, 154 to abrocitinib 200 mg, and 77 to placebo', 'abrocitinib monotherapy', 'oral abrocitinib 100 mg, abrocitinib 200 mg, or placebo', 'abrocitinib', 'placebo']","['Safety', 'proportion of patients who had achieved an Investigator Global Assessment response', 'Investigator Global Assessment response', 'Adverse events', 'Efficacy and safety', 'efficacy and safety', 'Efficacy', 'EASI-75 response', 'EASI score', 'Serious adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",387.0,0.611278,"Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group.","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Sinclair Dermatology, Melbourne, VIC, Australia.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'ForCare Clinical Research, Tampa, FL, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Aschoff', 'Affiliation': 'University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cork', 'Affiliation': ""Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield Children's Hospital, Sheffield Teaching Hospitals, Sheffield, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Miami Itch Center, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Magnolo', 'Affiliation': 'University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montréal, QC, Canada; University of Montreal Hospital Center, Montréal, QC, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Feeney', 'Affiliation': 'Pfizer UK, Surrey, UK.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Biswas', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Svitlana', 'Initials': 'S', 'LastName': 'Tatulych', 'Affiliation': 'Pfizer, Groton, CT, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer, Groton, CT, USA. Electronic address: ricardo.rojo@pfizer.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30732-7']
1667,32717273,Effect of high-velocity and traditional resistance exercise on serum antioxidants and inflammation biomarkers in older women: A randomized crossover trial.,"INTRODUCTION


Contrary to the production of oxidant and inflammation biomarkers, antioxidant enzymes decrease with age and the adaptive response to oxidative stress is reduced. The effects of the different resistance exercise protocols to attenuate these conditions are largely unexplored.
OBJECTIVE


We compared the acute effects of traditional resistance exercise (TRE) and high velocity RE (HVRE) on inflammatory biomarkers and antioxidant activity in elderly women.
METHODS


Fourteen elderly women (67 ± 7 years) were randomly assigned to TRE or HVRE. Blood samples were collected to measure inflammatory markers and antioxidant enzymes at three time-points (pre-exercise, post-exercise, 30 min post-exercise).
RESULTS


TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha, interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione and superoxide dismutase antioxidant levels without differences between groups. In addition, TRE and HVRE groups displayed acute increments in interleukin-10 (IL-10) and IL-10/IL-6 ratio over time, while the HVRE protocol displayed higher IL-10 values post-exercise and 30 min post-exercise time points as compared with TRE. Based on magnitude based inference, subjects from the HVRE group demonstrated superior responsiveness for IL-6 and IL-10 as compared with the TRE group. All participants from the HVRE group displayed a minimal clinical important difference on IL-10 levels as compared to only two persons from the TRE group.
CONCLUSION


Both RE protocols were capable of positive changes in inflammatory and antioxidant status in elderly subjects, but HVRE demonstrated a superior response on IL-10. The HVRE may be incorporated to exercise recommendation in this population.",2020,"TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels without differences between groups.","['older women', 'elderly subjects', 'Fourteen elderly women (67\u202f±\u202f7\u202fyears', 'elderly women']","['traditional resistance exercise (TRE) and high velocity RE (HVRE', 'HVRE', 'TRE or HVRE', 'TRE and HVRE', 'High-velocity and traditional resistance exercise']","['superior responsiveness for IL-6 and IL-10', 'inflammatory biomarkers and antioxidant activity', 'Minimal Clinical Important Difference (MCID) on IL-10 levels', 'tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels', 'interleukin-10 (IL-10) and IL-10/IL-6 ratio', 'serum antioxidants and inflammation biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",14.0,0.134689,"TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels without differences between groups.","[{'ForeName': 'Danilo Leandro Santos', 'Initials': 'DLS', 'LastName': 'de Castro', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Dahan', 'Initials': 'D', 'LastName': 'da Cunha Nascimento', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil; Department of Physical Education, Center University of Distrito Federal (UDF), Brasilia, Brazil; Department of Gerontology, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil.'}, {'ForeName': 'Vânia Silva Macedo', 'Initials': 'VSM', 'LastName': 'Orsano', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Ivo Vieira', 'Initials': 'IV', 'LastName': 'de Sousa Neto', 'Affiliation': 'Laboratory of Molecular Analysis, Graduate Program of Sciences and Technology of Health, University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Fabiani Lage Rodrigues', 'Initials': 'FLR', 'LastName': 'Beal', 'Affiliation': 'Department of Nutrition, Health and Medicine School, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil; Department of Gerontology, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil.'}, {'ForeName': 'Whitley', 'Initials': 'W', 'LastName': 'Stone', 'Affiliation': 'School of Kinesiology Recreation and Sport, Western Kentucky University, Bowling Green, USA.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dos Santos Rosa', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil. Electronic address: jonatop@gmail.com.'}]",Experimental gerontology,['10.1016/j.exger.2020.111026']
1668,32718816,"First-in-human administration of a live-attenuated RSV vaccine lacking the G-protein assessing safety, tolerability, shedding and immunogenicity: a randomized controlled trial.","BACKGROUND


Human respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections in early infancy and in elderly. A pediatric vaccine against RSV would not only prevent morbidity and mortality amongst infants and young children but could also reduce transmission to elderly. The RSVΔG vaccine consists of a live-attenuated RSV that lacks the G attachment protein. RSVΔG is severely impaired in binding to host cells and exhibits reduced infectivity in preclinical studies. Intranasal immunization of cotton rats with RSVΔG vaccine protected against replication of wildtype RSV, without inducing enhanced disease.
METHODS


We performed a first-in-human trial with primary objective to evaluate safety and shedding of RSVΔG (6.5 log 10  CCID 50 ) after intranasal administration. Healthy adults aged between 18 and 50, with RSV neutralizing serum titers below 9.6 log 2 , received a single dose of either vaccine or placebo (n = 48, ratio 3:1). In addition to safety and tolerability, nasal viral load, and systemic and humoral immune responses were assessed at selected time points until 4 weeks after immunization.
RESULTS


Intranasal administration of RSVΔG was well tolerated with no findings of clinical concern. No infectious virus was detected in nasal wash samples. Similar to other live-attenuated RSV vaccines, neutralizing antibody response following inoculation was limited in seropositive adults.
CONCLUSIONS


A single dose of 6.5 log 10  CCID 50  of RSVΔG was safe and well-tolerated in seropositive healthy adults. RSVΔG was sufficiently attenuated but there were no signs of induction of antibodies. Safety and immunogenicity can now be explored in children and eventually in seronegative infants. Clinical trial register: NTR7173/EudraCT number 2016-002437-30.",2020,"In addition to safety and tolerability, nasal viral load, and systemic and humoral immune responses were assessed at selected time points until 4 weeks after immunization.
","['seropositive healthy adults', 'early infancy and in elderly', 'infants and young children', 'children and eventually in seronegative infants', 'number 2016-002437-30', 'Healthy adults aged between 18 and 50, with RSV neutralizing serum titers below 9.6 log 2 , received a single dose of either', 'cotton rats with']","['RSVΔG', 'RSVΔG vaccine', 'vaccine or placebo', 'NTR7173/EudraCT']","['morbidity and mortality', 'safety, tolerability, shedding and immunogenicity', 'Safety and immunogenicity', 'safety and tolerability, nasal viral load, and systemic and humoral immune responses']","[{'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034695', 'cui_str': 'Rats, Cotton'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}]",,0.293366,"In addition to safety and tolerability, nasal viral load, and systemic and humoral immune responses were assessed at selected time points until 4 weeks after immunization.
","[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Verdijk', 'Affiliation': 'Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.'}, {'ForeName': 'Johan L', 'Initials': 'JL', 'LastName': 'van der Plas', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands; Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Emilie M J', 'Initials': 'EMJ', 'LastName': 'van Brummelen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rienk E', 'Initials': 'RE', 'LastName': 'Jeeninga', 'Affiliation': 'Viroclinics Biosciences B.V., Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis A M', 'Initials': 'CAM', 'LastName': 'de Haan', 'Affiliation': 'Virology Division, Department Biomolecular Health Sciences, Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands; Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands; Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ingrid M C', 'Initials': 'IMC', 'LastName': 'Kamerling', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands; Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: IdVisser@chdr.nl.'}]",Vaccine,['10.1016/j.vaccine.2020.07.029']
1669,32720457,Examining the interdependence of parent-child dyads: Effects on weight loss and maintenance.,"BACKGROUND


This study aimed to further elucidate correlated weight changes in parent-child dyads enrolled in family-based treatment (FBT) by modeling the interdependence of weight changes during treatment.
METHODS


Parent-child dyads (n = 172) with overweight/obesity (child mean zBMI = 2.16 ± 0.39; parent mean BMI = 37.9 ± 9.4 kg/m 2  ) completed 4 months of FBT and were randomized to one of three 8-month maintenance interventions (Social Facilitation Maintenance [SFM]-high dose, SFM-low dose or control). Weight/height was measured at 0, 4 and 12 months. Structural equation models simultaneously estimated the effect that an individual had on their own (actor effect) and on one another's (partner effect) weight-status across time using the actor-partner interdependence model.
RESULTS


Actor paths were significant over time for parent and child. Partner paths were significant for child zBMI predicting parent BMI at 4 and 12 months. Maintenance condition moderated actor/partner paths in the model.
CONCLUSIONS


Child weight change may motivate parents to make environmental and behavioural changes that impact their own weight.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT00759746.",2020,Partner paths were significant for child zBMI predicting parent BMI at 4 and 12 months.,"['Parent-child dyads (n = 172) with overweight/obesity (child mean zBMI = 2.16\u2009±\u20090.39', 'parent-child dyads enrolled in family-based treatment (FBT']","['maintenance interventions (Social Facilitation Maintenance [SFM]-high dose, SFM-low dose or control']","['weight loss and maintenance', 'Weight/height', 'weight changes', 'child zBMI predicting parent BMI']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4552097', 'cui_str': 'Epidermal nevus syndrome'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",172.0,0.0215294,Partner paths were significant for child zBMI predicting parent BMI at 4 and 12 months.,"[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Grammer', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Mary Katherine', 'Initials': 'MK', 'LastName': 'Ray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Balantekin', 'Affiliation': 'Department of Exercise and Nutrition Sciences, University of Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Stein', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Kolko Conlon', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R Robinson', 'Initials': 'RR', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical & Health Psychology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Pediatric obesity,['10.1111/ijpo.12697']
1670,32725791,"Supplemental CO 2  improves oxygen saturation, oxygen tension ,  and cerebral oxygenation in acutely hypoxic healthy subjects.","Oxygen is viewed in medicine as the sole determinant of tissue oxygenation, though carbon dioxide homeostasis is equally important and clinically often ignored. The aims of this study were as follows: (a) to examine the effects of different acute hypoxic conditions on partial pressure of arterial oxygen (  Pa   O   2      ), arterial oxygen saturation of hemoglobin (  Sa   O   2      ), and regional cerebral saturation of hemoglobin (rSO 2  ); and (b) to evaluate supplemental CO 2  as a tool to improve oxygenation in acutely hypoxic individuals. We hypothesized that exposure to gas mixtures with added CO 2  would improve oxygenation in hypoxic human subjects. Twenty healthy subjects were exposed to 5-min intervals of two gas mixtures: hypoxic gas mixture containing 8% oxygen, and a CO 2  -enriched mixture containing 8% oxygen plus either 3% or 5% CO 2  . Ten subjects received the 3% CO 2  -enriched mixture, and the remaining 10 subjects received the 5% CO 2  -enriched mixture. The order of exposure was randomized. Blood gases, pulse oximetry, end-tidal CO 2  , and cerebral oximetry were measured. Compared to the purely hypoxic gas group,  Pa   O   2      was increased in the 3% and 5% CO 2  -enriched groups by 14.9 and 9.5 mmHg, respectively. Compared to pure hypoxia,  Sa   O   2      was increased in the 3% and 5% CO 2  -enriched groups by 16.8% and 12.9%, respectively. Both CO 2  -enriched gas groups had significantly higher end-exposure rSO 2  and recovered to baseline rSO 2  within 1 min, compared to the pure hypoxic gas group, which returned to baseline in 5 min. These results suggest that in acutely hypoxic subjects, CO 2  supplementation improves blood oxygen saturation and oxygen tension as well as cerebral oxygenation measures.",2020,"Both CO 2  -enriched gas groups had significantly higher end-exposure rSO 2  and recovered to baseline rSO 2  within 1 min, compared to the pure hypoxic gas group, which returned to baseline in 5 min.","['acutely hypoxic individuals', 'hypoxic human subjects', 'Twenty healthy subjects', 'acutely hypoxic healthy subjects']","['pure hypoxia,  Sa', 'hypoxic gas mixture containing 8% oxygen, and a CO 2  -enriched mixture containing 8% oxygen plus either 3% or 5% CO 2  ']","['Blood gases, pulse oximetry, end-tidal CO 2  , and cerebral oximetry', 'partial pressure of arterial oxygen (  Pa   O   2      ), arterial oxygen saturation of hemoglobin (  Sa   O   2      ), and regional cerebral saturation of hemoglobin (rSO 2  ', 'Pa   O   2', 'blood oxygen saturation and oxygen tension', 'oxygen saturation, oxygen tension ,  and cerebral oxygenation', 'cerebral oxygenation measures']","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0068879', 'cui_str': 'nitrox'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.0431829,"Both CO 2  -enriched gas groups had significantly higher end-exposure rSO 2  and recovered to baseline rSO 2  within 1 min, compared to the pure hypoxic gas group, which returned to baseline in 5 min.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stepanek', 'Affiliation': 'Mayo Clinic, Aerospace Medicine and Vestibular Research Laboratory (AMVRL), Scottsdale, AZ, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Dunn', 'Affiliation': 'Mayo Clinic Alix School of Medicine, Scottsdale, AZ, USA.'}, {'ForeName': 'Gaurav N', 'Initials': 'GN', 'LastName': 'Pradhan', 'Affiliation': 'Mayo Clinic, Aerospace Medicine and Vestibular Research Laboratory (AMVRL), Scottsdale, AZ, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cevette', 'Affiliation': 'Mayo Clinic, Aerospace Medicine and Vestibular Research Laboratory (AMVRL), Scottsdale, AZ, USA.'}]",Physiological reports,['10.14814/phy2.14513']
1671,32721986,Effect of a Multicomponent Intervention Program on Community-Dwelling People With Intellectual Disabilities.,"OBJECTIVE


To investigate the effectiveness of a novel and complex intervention in community-dwelling people with intellectual disabilities.
METHODS


Forty-three participants completed the experiment. The subjects were randomly assigned the experimental (n=33) or control (n=10) groups. The multicomponent intervention program comprised exercise and nutrition management and behavior modification. The intervention was performed for 60 minutes once weekly for 10 weeks. The assessment included anthropometric data, body composition and blood pressure analysis, and blood tests. In addition, pulmonary function, physical function, and health-related quality of life were measured before and after the intervention.
RESULTS


No adverse events occurred during the intervention. After the intervention, the experimental group showed a significantly higher increase in high-density lipoprotein cholesterol level than did the control group (effect size=0.152, p=0.019).
CONCLUSION


This innovative intervention was effective in improving cardiovascular health. Even greater effects could be achieved through improvements in implementation strategies to increase compliance.",2020,"After the intervention, the experimental group showed a significantly higher increase in high-density lipoprotein cholesterol level than did the control group (effect size=0.152, p=0.019).
","['Methods\n\n\nForty-three participants completed the experiment', 'community-dwelling people with intellectual disabilities', 'Community-Dwelling People With Intellectual Disabilities']","['novel and complex intervention', 'multicomponent intervention program comprised exercise and nutrition management and behavior modification', 'Multicomponent Intervention Program']","['cardiovascular health', 'anthropometric data, body composition and blood pressure analysis, and blood tests', 'adverse events', 'pulmonary function, physical function, and health-related quality of life', 'high-density lipoprotein cholesterol level']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1258068', 'cui_str': 'Nutrition management'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}]",43.0,0.0433813,"After the intervention, the experimental group showed a significantly higher increase in high-density lipoprotein cholesterol level than did the control group (effect size=0.152, p=0.019).
","[{'ForeName': 'Ye-Soon', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Healthcare and Public Health Research, National Rehabilitation Research Institute, National Rehabilitation Center, Seoul, Korea.'}, {'ForeName': 'Jong-Hoon', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Healthcare and Public Health Research, National Rehabilitation Research Institute, National Rehabilitation Center, Seoul, Korea.'}, {'ForeName': 'Bo Kyoon', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Department of Occupational Therapy, Graduate School, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Seung Hee', 'Initials': 'SH', 'LastName': 'Ho', 'Affiliation': 'Department of Healthcare and Public Health Research, National Rehabilitation Research Institute, National Rehabilitation Center, Seoul, Korea.'}]",Annals of rehabilitation medicine,['10.5535/arm.19124']
1672,32721988,A Fully Immersive Virtual Reality Method for Upper Limb Rehabilitation in Spinal Cord Injury.,"OBJECTIVE


To determine whether a fully immersive virtual reality (VR) intervention combined with conventional rehabilitation (CR) can improve upper limb function more than CR alone in patients with spinal cord injury (SCI), we conducted a prospective, randomized, controlled clinical trial.
METHODS


Participants were randomly assigned to either the control group (CG; n=10) or experimental group (EG; n=10). The participants in the CG received 60 minutes of conventional therapy per day, 4 days per week for 4 weeks, whereas those in the EG received 30 minutes of VR training and 30 minutes of conventional therapy per day, 4 days per week for 4 weeks. The clinical outcome measures included Medical Research Council grade, the American Spinal Injury Association upper extremity motor score (ASIA-UEMS), and scores in the Hand Strength Test, Box and Block Test, Nine-Hole Peg Test, Action Research Arm Test, and Korean version of the Spinal Cord Independence Measure (K-SCIM). The assessments were performed at the beginning (T0) and end of the intervention (T1).
RESULTS


Grip power and K-SCIM score significantly improved in the EG after the intervention. When comparing differences between the groups, elbow extensor, wrist extensor, ASIA-UEMS, grip power, lateral pinch power, and palmar pinch power were all significantly improved.
CONCLUSION


VR training of upper limb function after SCI can provide an acceptable adjunctive rehabilitation method without significant adverse effects.",2020,"When comparing differences between the groups, elbow extensor, wrist extensor, ASIA-UEMS, grip power, lateral pinch power, and palmar pinch power were all significantly improved.
","['Spinal Cord Injury', 'patients with spinal cord injury (SCI']","['CR alone', 'fully immersive virtual reality (VR) intervention combined with conventional rehabilitation (CR', 'conventional therapy', 'VR training and 30 minutes of conventional therapy']","['Grip power and K-SCIM score', 'Medical Research Council grade, the American Spinal Injury Association upper extremity motor score (ASIA-UEMS), and scores in the Hand Strength Test, Box and Block Test, Nine-Hole Peg Test, Action Research Arm Test, and Korean version of the Spinal Cord Independence Measure (K-SCIM', 'elbow extensor, wrist extensor, ASIA-UEMS, grip power, lateral pinch power, and palmar pinch power']","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}]",,0.035922,"When comparing differences between the groups, elbow extensor, wrist extensor, ASIA-UEMS, grip power, lateral pinch power, and palmar pinch power were all significantly improved.
","[{'ForeName': 'Da Young', 'Initials': 'DY', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Dong Min', 'Initials': 'DM', 'LastName': 'Hwang', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Kang Hee', 'Initials': 'KH', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Chang Won', 'Initials': 'CW', 'LastName': 'Moon', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Ahn', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}]",Annals of rehabilitation medicine,['10.5535/arm.19181']
1673,32729244,"Effects of short-term xylitol chewing gum on pro-inflammatory cytokines and Streptococcus mutans: A randomised, placebo-controlled trial.","INTRODUCTION


Dental caries is an infectious disease with predominantly of cariogenic bacteria such as Streptococcus mutans (S mutans). Xylitol is considered as one of the effective agents that can limit this dental infection. In this randomised, placebo-controlled trial, we aimed to evaluate the potential reflection of short-term xylitol consumption on pro-inflammatory cytokines (TNF-α, IL-6 and IL-8) and S mutans counts by ELISA and qPCR (Quantitative real-time PCR), respectively.
METHODS


In this study, 154 participants were assigned to two groups, control and xylitol. Dental examination, saliva and swab samples were done at baseline and at 3-week for clinical and microbiological assessment.
RESULTS


In xylitol group at the end of 3-week, gingival and plaque index scores were significantly decreased with respect to baseline values (P < .001 and P < .05, respectively). The salivary concentration of TNF-α, IL-6 and IL-8 were statistically declined at 3-week, more so than those at baseline in xylitol group (P < .001). S mutans expression was reduced about fivefold at 3-week use of xylitol and it was a statistically significant difference compared to baseline (P < .001).
CONCLUSION


Intriguingly, even short-term consumption of xylitol might play a favourable role in maintaining the oral health status, possibly as a result of decreasing the release of pro-inflammatory cytokines and the counts of S mutans. Nonetheless, this investigation warrants further endorsement.",2020,"The salivary concentration of TNF-α, IL-6 and IL-8 were statistically declined at 3-week, more so than those at baseline in xylitol group (p<0.001).",['154 participants'],"['xylitol', 'short-term xylitol chewing gum', 'Xylitol', 'control and xylitol', 'placebo']","['pro-inflammatory cytokines (TNF-α, IL-6 and IL-8) and S. mutans counts by ELISA and qPCR (Quantitative real-time PCR', 'gingival and plaque index scores', 'pro-inflammatory cytokines and Streptococcus mutans', 'S. mutans expression', 'salivary concentration of TNF-α, IL-6 and IL-8']","[{'cui': 'C5191279', 'cui_str': '154'}]","[{'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",154.0,0.136313,"The salivary concentration of TNF-α, IL-6 and IL-8 were statistically declined at 3-week, more so than those at baseline in xylitol group (p<0.001).","[{'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Akgül', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, Istanbul Aydin University, Istanbul, Turkey.'}, {'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Topaloğlu Ak', 'Affiliation': 'Department of Pedodontics, School of Dentistry, Istanbul Aydin University, Istanbul, Turkey.'}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Zorlu', 'Affiliation': 'Department of Pedodontics, School of Dentistry, Istanbul Aydin University, Istanbul, Turkey.'}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Öner Özdaş', 'Affiliation': 'Department of Pedodontics, School of Dentistry, Istanbul Aydin University, Istanbul, Turkey.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Uslu', 'Affiliation': 'Department of Pedodontics, School of Dentistry, Istanbul Aydin University, Istanbul, Turkey.'}, {'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Çayirgan', 'Affiliation': 'Department of Pedodontics, School of Dentistry, Istanbul Aydin University, Istanbul, Turkey.'}]",International journal of clinical practice,['10.1111/ijcp.13623']
1674,32726513,Scalene and sternocleidomastoid activation during normoxic and hypoxic incremental inspiratory loading.,"The purpose of this study was to examine scalene (SA) and sternocleidomastoid (SM) activation during normoxic (norm-ITL; FIO 2   = 21%) and hypoxic (hyp-ITL; FIO 2   = 15%) incremental inspiratory threshold loading (ITL). Thirteen healthy participants (33 ± 4 years, 9 female) performed two ITL tests breathing randomly assigned gas mixtures through an inspiratory loading device where the load was increased every two minutes until task failure. SA and SM root mean square (RMS) electromyography (EMG) were calculated and expressed as a percentage of maximum (RMS %max  ) to reflect muscle activation intensity. Myoelectric manifestations of fatigue were characterized as decreased SA or SM EMG median frequency during maximum inspiratory pressure maneuvers before and after ITL. Dyspnea was recorded at baseline and task failure. Ventilatory parameters and mouth pressure (Pm) were recorded throughout the ITL. SA,RMS %max  and SM,RMS %max  increased in association with ITL load (p ≤ .01 for both). SA,RMS %max  was similar between norm-ITL and hyp-ITL (p = .17), whereas SM,RMS %max  was greater during the latter (p = .001). Neither SA nor SM had a decrease in EMG median frequency after ITL (p = .75 and 0.69 respectively). Pm increased in association with ITL load (p < .001) and tended to be higher during hyp-ITL compared to norm-ITL (p = .05). Dyspnea was similar during both conditions (p > .05). There was a trend for higher tidal volumes during hyp-ITL compared to norm-ITL (p = .10). Minute ventilation was similar between both conditions (p = .23). RMS, %max  of the SA and SM increased linearly with increasing ITL. The presence of hypoxia only increased SM activation. Neither SA nor SM presented myoelectric manifestations of fatigue during both conditions.",2020,"SA,RMS %max  and SM,RMS %max  increased in association with ITL load (p ≤ .01 for both).","['Thirteen healthy participants (33\xa0±\xa04 years, 9 female']",['ITL tests breathing randomly assigned gas mixtures through an inspiratory loading device'],"['Dyspnea', 'scalene (SA) and sternocleidomastoid (SM) activation', 'EMG median frequency', 'RMS, %max  of the SA and SM increased linearly with increasing ITL', 'SA,RMS %max', 'Ventilatory parameters and mouth pressure (Pm', 'SM activation', 'Minute ventilation', 'SA and SM root mean square (RMS) electromyography (EMG', 'higher tidal volumes', 'ITL load']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0581444', 'cui_str': 'Gas mixture'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",13.0,0.023465,"SA,RMS %max  and SM,RMS %max  increased in association with ITL load (p ≤ .01 for both).","[{'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Basoudan', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, BC, Canada.'}, {'ForeName': 'Antenor', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Physical Therapy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Gallina', 'Affiliation': 'Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Garland', 'Affiliation': 'Faculty of Health Sciences, Western University, London, ON, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, BC, Canada.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Shadgan', 'Affiliation': 'International Collaboration on Repair Discoveries, Vancouver, BC, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Road', 'Affiliation': 'Division of Respiratory Medicine, Department of Medicine, University of British Columbia (UBC), Vancouver, BC, Canada.'}, {'ForeName': 'W Darlene', 'Initials': 'WD', 'LastName': 'Reid', 'Affiliation': 'Physical Therapy, University of Toronto, Toronto, ON, Canada.'}]",Physiological reports,['10.14814/phy2.14522']
1675,32732772,Effectiveness of a 2-Week Strength Training Learning Intervention on Self-selected Weight-Training Intensity.,"Glass, SC, Ahmad, S, and Gabler, T. Effectiveness of a 2-week strength training learning intervention on self-selected weight-training intensity. J Strength Cond Res 34(9): 2443-2448, 2020-The purpose of this study was to determine the effectiveness of an imposed (IM) vs. self-selected (SS) 2-week strength training intervention on SS resistance training intensity. Subjects 18-40 years (SS n = 10 and IM n = 10) were provided resistance training orientation (chest press, leg press, triceps extension, bicep curl, and shoulder press). On 6 different training days, subjects completed 2 sets on each machine while blinded to the load. The SS group SS loads without any intensity or effort feedback. Load, repetitions, and ratings of perceived exertion (RPE) were recorded. The IM group was encouraged to lift to fatigue, and if they exceeded 12 repetitions, subsequent load was increased (goal-attain 70% one repetition maximum [1RM]). After training, SS and IM SS loads and repetitions for all lifts, plus 3 novel lifts (pec fly, leg extension, and shoulder raise). One repetition maximum was assessed last. Comparisons between groups were made using 2-way analysis of variance. There were significant main effects for % 1RM for the condition and day (day 1 IM = 57.2 ± 12.0%, SS = 47.2 ± 13.7% and day 6 IM = 74.7 ± 10.8%, SS = 66.2 ± 13.4%). There were significant effects across days for reps (day 1 IM = 10.8 ± 4.8, SS = 12.3 ± 4.0 and day 6 IM = 9.3 ± 3.6, SS = 10.0 ± 3.0) and RPE (day 1 = 15.4 ± 2.0 and day 6 = 16.5 ± 1.9). For both SS and IM post-training SS loads exceeded 60% 1RM. However, among the novel lifts, only the pec fly was greater than 60% 1RM (pec fly 63.0 ± 11.0%, leg extension 39.8 ± 12.5%, and shoulder raise 53.1 ± 12.8%). Two weeks of supervised resistance training resulted in both IM and SS self-selecting loads greater than 60% 1RM. There were no differences after 2-weeks of training between IM load and SS load groups.",2020,"There were significant effects across days for reps (day 1 IM = 10.8 ± 4.8, SS = 12.3 ± 4.0 and day 6 IM = 9.3 ± 3.6, SS = 10.0 ± 3.0) and RPE (day 1 = 15.4 ± 2.0 and day 6 = 16.5 ± 1.9).",['Subjects 18-40 years (SS n = 10 and IM n = 10'],"['J Strength Cond Res XX(X', 'strength training learning intervention', 'resistance training orientation (chest press, leg press, triceps extension, bicep curl, and shoulder press', 'imposed (IM) vs. self-selected (SS', 'supervised resistance training', '2-Week Strength Training Learning Intervention', '2-week strength training intervention']","['Load, repetitions, and ratings of perceived exertion (RPE', 'SS resistance training intensity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0454325', 'cui_str': 'Shoulder press'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",10.0,0.012273,"There were significant effects across days for reps (day 1 IM = 10.8 ± 4.8, SS = 12.3 ± 4.0 and day 6 IM = 9.3 ± 3.6, SS = 10.0 ± 3.0) and RPE (day 1 = 15.4 ± 2.0 and day 6 = 16.5 ± 1.9).","[{'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Glass', 'Affiliation': 'Department of Movement Science, Human Performance Laboratory, Grand Valley State University, Allendale, Michigan.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gabler', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003729']
1676,32732774,Can Simulated Partners Boost Workout Effort in Long-Term Exercise?,"Feltz, DL, Hill, CR, Samendinger, S, Myers, ND, Pivarnik, JM, Winn, B, Ede, A, and Ploutz-Snyder, L. Can simulated partners boost workout effort in long-term exercise? J Strength Cond Res 34(9): 2434-2442, 2020-We tested whether exercising with a stronger simulated (i.e., software-generated) partner leads to greater work effort compared to exercising alone, to help those seeking to maintain or improve fitness levels with long-term high-intensity training, but who find it necessary or practical to exercise in social isolation. Forty-one middle-aged adults, who participated in at least 30 minutes of vigorous exercise 3x·wk, trained on a cycle ergometer 6 days per week for 24 weeks in an alternating regimen of moderate-intensity 30-minute continuous and 3 types of high-intensity interval sessions (8 × 30-second sprints, 6 × 2-minute ladders, and 4 × 4-minute intervals). They were assigned either no partner (control), an always superior partner, or a not always superior partner. Participants varied cycle power output to increase or decrease session intensity during the repeated moderate-intensity sessions (30-minute continuous) and 1 of the 3 high-intensity sessions (4 × 4-minute intervals). Changes in intensity were used as a measure of effort motivation over time. Nested multilevel models of effort trajectory were developed and alpha was set to 0.05. For continuous and interval sessions, effort trajectory was positive and significant for those with an always superior partner, but not significantly different from control. Within interval sessions, those with an always superior partner significantly increased effort in the fourth interval compared to control (p = 0.02). Exercising with an always superior partner leads to greater work efforts during the hardest interval training compared to exercising alone.",2020,Exercising with an always superior partner leads to greater work efforts during the hardest interval training compared to exercising alone.,"['Forty-one middle-aged adults, who participated in at least 30 minutes of']","['J Strength Cond Res XX(X', 'exercising with a stronger simulated (i.e., software-generated) partner leads to greater work effort compared to exercising alone, to help those seeking to maintain or improve fitness levels with long-term high-intensity training, but who find it necessary or practical to exercise in social isolation', 'vigorous exercise 3x·wk, trained on a cycle ergometer 6 days per week for 24 weeks in an alternating regimen of moderate-intensity 30-minute continuous and 3 types of high-intensity interval sessions']","['session intensity', 'Feltz, DL, Hill, CR, Samendinger, S, Myers, ND, Pivarnik, JM, Winn, B, Ede, A, and Ploutz-Snyder']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0442532', 'cui_str': 'Hill'}]",41.0,0.015072,Exercising with an always superior partner leads to greater work efforts during the hardest interval training compared to exercising alone.,"[{'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Feltz', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Hill', 'Affiliation': 'Department of Kinesiology, California State University, San Bernardino, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Samendinger', 'Affiliation': 'Department of Health Promotion and Wellness, Farmingdale State College, Farmingdale, New York.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Myers', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Pivarnik', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Winn', 'Affiliation': 'Department of Media and Information, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ede', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, California.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Ploutz-Snyder', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003732']
1677,32735021,Platelet-rich Plasma for Androgenetic Alopecia Treatment: A Randomized Placebo-controlled Pilot Study.,"Platelet-rich plasma injections have been presented as an effective treatment for androgenetic alopecia; however, reliable study data concerning this therapy are lacking. The current randomized, placebo-controlled pilot study explored this novel therapy in 30 healthy male subjects with androgenetic alopecia. Five platelet-rich plasma treatments, at intervals of 4-6 weeks, and 2 follow-up examinations were performed. Twenty subjects were injected intracutaneously with platelet-rich plasma and 10 with physiological saline. Treatment efficacy was assessed by changes in hair number and diameter, measured with the TrichoScan system. A secondary objective was to assess clinical improvement, which was evaluated by an independent reviewer using patient photographs and a 5-point Likert scale. In addition, subject satisfaction was assessed by survey. No improvements were seen over the course of the trial, using TrichoScan measurements or visual assessment. In conclusion, these results suggest that treatment with platelet-rich plasma as a monotherapy does not improve hair growth in men with androgenetic alopecia.",2020,"No improvements were seen over the course of the trial, using TrichoScan measurements or visual assessment.","['30 healthy male subjects with androgenetic alopecia', 'Twenty subjects were', 'Androgenetic Alopecia Treatment', 'men with androgenetic alopecia']","['Platelet-rich plasma injections', 'injected intracutaneously with platelet-rich plasma and 10 with physiological saline', 'Placebo', 'placebo']","['TrichoScan measurements or visual assessment', 'hair growth']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0232407', 'cui_str': 'Hair growth'}]",30.0,0.0799981,"No improvements were seen over the course of the trial, using TrichoScan measurements or visual assessment.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gressenberger', 'Affiliation': 'Department of Dermatology, Medical University of Graz, AT-8036 Graz, Austria. paul.gressenberger@medunigraz.at.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Pregartner', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gary', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Kopera', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3609']
1678,32730920,The role of endogenous GIP and GLP-1 in postprandial bone homeostasis.,"The incretin hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are well known for their insulinotropic effects and they are thought to affect bone homeostasis as mediators in the so-called entero-osseous axis. We examined the contributions of endogenous GIP and GLP-1, respectively, to postprandial bone homeostasis, in healthy subjects in two randomized and double-blind crossover studies. We included healthy men who received either four oral glucose tolerance tests (OGTTs) (n = 18, median age 27 (range 20-70), BMI 27.2 (22.4-37.0) kg/m 2 ) or liquid mixed meal tests (MMTs) (n = 12, age 23 (19-65), BMI 23.7 (20.3-25.5) kg/m 2 ) with infusions of 1) the GIP receptor antagonist GIP(3-30)NH 2 , 2) the GLP-1 receptor antagonist exendin(9-39)NH 2 , 3) both GIP(3-30)NH 2  and exendin(9-39)NH 2 , or 4) placebo infusions (saline) on four separate visits. Bone resorption was evaluated from levels of circulating carboxy-terminal collagen crosslinks (CTX) and bone formation from levels of procollagen type 1 amino-terminal propeptide (P1NP). During placebo infusions, baseline-subtracted area under the curve values for CTX were -39 ± 5.0 (OGTT) and -57 ± 4.3 ng/ml × min (MMT). When GIP(3-30)NH 2  was administered, CTX suppression was significantly diminished compared to placebo (-30 ± 4.8 (OGTT) and -45 ± 4.6 ng/ml × min (MMT), P = 0.0104 and P = 0.0288, respectively, compared to placebo. During exendin(9-39)NH 2  infusion, CTX suppression after OGTT/MMT was similar to placebo (P = 0.28 (OGTT) and P = 0.93 (MMT)). The relative contribution of endogenous GIP to postprandial suppression of bone resorption during both OGTT and MMT was similar and reached 22-25%. There were no differences in P1NP concentrations between interventions. In conclusion, endogenous GIP contributes by up to 25% to postprandial suppression of bone resorption in humans whereas an effect of endogenous GLP-1 could not be demonstrated.",2020,There were no differences in P1NP concentrations between interventions.,"['healthy subjects', 'healthy men who received either four oral glucose tolerance tests (OGTTs) (n = 18, median age 27 (range 20-70), BMI 27.2 (22.4-37.0) kg/m 2 ) or']","['liquid mixed meal tests (MMTs', 'placebo infusions (saline', 'placebo']","['bone resorption', 'CTX suppression', 'P1NP concentrations', 'Bone resorption']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191357', 'cui_str': '27.2'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.20213,There were no differences in P1NP concentrations between interventions.,"[{'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Stensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark. Electronic address: filipknop@dadlnet.dk.'}]",Bone,['10.1016/j.bone.2020.115553']
1679,32730930,A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures.,"Bone morphogenetic proteins (BMPs) are known to induce new bone formation in vivo but treating trabecular bone defects with a BMP based therapeutic remains controversial. Here, we evaluated the safety and efficacy of a novel Autologous Bone Graft Substitute (ABGS) comprised of recombinant human BMP6 (rhBMP6) dispersed within an autologous blood coagulum (ABC) as a physiological natural carrier in patients with a closed distal radial fracture (DRF). We enrolled 32 patients in a randomized, standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase I First in Human (FiH) clinical trial. ABGS was prepared from peripheral blood as 250 μg rhBMP6/mL ABC or PBO (1 mL ABC containing excipients only) and was administered dorsally via a syringe injection into the fracture site following closed fracture fixation with 3 Kirschner wires. Patients carried an immobilization for 5 weeks and were followed-up for 0 to 26 weeks by clinical examination, safety, serial radiographic analyses and CT. During the 13 weeks follow-up and at 26 weeks post study there were no serious adverse reactions recorded. The results showed that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 32 patients at 13- and 26-weeks following treatment. Pharmacokinetic analyses of plasma from patients treated with ABGS showed no detectable rhBMP6 at any time point within the first 24 h following administration. The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P = 0.027), while at week 13 all patients had similar healing outcomes. In conclusion, we show that intraosseous administration of ABGS (250 μg rhBMP6/mL ABC) into the distal radial fracture site demonstrated a good tolerability with no serious adverse reactions as well as early accelerated trabecular bone healing as compared to control PBO and SoC patients.",2020,"The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes.","['patients with distal radial fractures', 'patients with a closed distal radial fracture (DRF']","['ABGS', 'novel Autologous Bone Graft Substitute (ABGS', 'standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase', 'novel autologous bone graft substitute', 'Bone morphogenetic proteins (BMPs', 'recombinant human BMP6 (rhBMP6']","['accelerated bone healing', 'safety and efficacy', 'CT image and radiographic analyses score', 'detectable anti-rhBMP6 antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0053932', 'cui_str': 'Bone morphogenetic proteins'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",32.0,0.0547507,"The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes.","[{'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Durdevic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Vlahovic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Pehar', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Miklic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Oppermann', 'Affiliation': 'Genera Research, Svetonedeljska 2, Kalinovica, 10436, Rakov Potok, Croatia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Bordukalo-Niksic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Ismet', 'Initials': 'I', 'LastName': 'Gavrankapetanovic', 'Affiliation': 'University Clinical Center Sarajevo, Clinic of Orthopedics and Traumatology, Bolnicka 25, 71000 Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Mehmed', 'Initials': 'M', 'LastName': 'Jamakosmanovic', 'Affiliation': 'University Clinical Center Sarajevo, Clinic of Orthopedics and Traumatology, Bolnicka 25, 71000 Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'School of Public Health ""Andrija Stampar"", University of Zagreb School of Medicine, Rockefellerova 4, 10000 Zagreb, Croatia.'}, {'ForeName': 'Snjezana', 'Initials': 'S', 'LastName': 'Martinovic', 'Affiliation': 'SmartMedico, Zupanova 5, 10000 Zagreb, Croatia.'}, {'ForeName': 'T Kuber', 'Initials': 'TK', 'LastName': 'Sampath', 'Affiliation': 'perFormBiologics Inc., Holliston, MA 01746, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department for Intracellular Communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 2, 10000 Zagreb, Croatia.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Grgurevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Vukicevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia. Electronic address: slobodan.vukicevic@mef.hr.'}]",Bone,['10.1016/j.bone.2020.115551']
1680,32730948,An Integrative Clustering Approach to tDCS Individual Response Variability in Cognitive Performance: Beyond a Null Effect on Working Memory.,"Despite the growing interest in the use of transcranial direct current stimulation (tDCS) for the modulation of human cognitive function, there are contradictory findings regarding the cognitive benefits of this technique. Inter-individual response variability to tDCS may play a significant role. We explored the effects of anodal versus sham tDCS over the left prefrontal cortex (LPFC) on working memory performance, taking into account the inter-individual variability. Twenty-nine healthy volunteers received an 'offline' anodal tDCS (1.5 mA, 15 min) to the left prefrontal cortex (F3 electrode site) in an intra-individual, cross-over, sham-controlled experimental design. n-back and Sternberg task performance was assessed before (baseline), immediately after tDCS administration (T1) and 5 min post-T1 (T2). We applied an integrative clustering approach to characterize both the group and individual responses to tDCS, as well as identifying naturally occurring subgroups that may be present within the total sample. Anodal tDCS failed to improve working memory performance in the total sample. Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition. The proportion of 'responders' ranged from 15% to 59% across task conditions and behavioral outputs. Our findings show a high inter-individual variability of the tDCS response, suggesting that the use of tCDS may not be an effective tool to improve working memory performance in healthy subjects. We propose that the use of clustering methods is more suitable in identifying 'responders' and for evaluating the efficacy of this technique.",2020,"Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition.","['Twenty-nine healthy volunteers', 'healthy subjects']","['Anodal tDCS', 'transcranial direct current stimulation (tDCS', 'anodal versus sham tDCS', ""offline' anodal tDCS (1.5mA, 15min) to the left prefrontal cortex (F3 electrode site) in an intra-individual, cross-over, sham-controlled experimental design""]","['n-back and Sternberg task performance', 'working memory performance']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",29.0,0.0384338,"Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Luque-Casado', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Rodríguez-Freiría', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group, A Coruña, Spain.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Fogelson', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group, A Coruña, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernández-Del-Olmo', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain. Electronic address: miguel.delolmo@urjc.es.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.036']
1681,32784117,Idebenone does not inhibit disability progression in primary progressive MS.,"BACKGROUND


Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disorder of the central nervous system (CNS). While current MS therapies target the inflammatory processes, no treatment explicitly targets mitochondrial dysfunction and resulting axonal loss. Therefore, the aim of this study was to determine whether idebenone inhibits mitochondrial dysfunction and accumulation of disability in primary progressive MS (PPMS) and to enhance understanding of pathogenic mechanisms of PPMS progression using cerebrospinal fluid (CSF) biomarkers.
METHODS


The double-blind, placebo-controlled Phase I/II clinical trial of Idebenone in patients with Primary Progressive MS (IPPoMS; NCT00950248) was an adaptively designed, baseline-versus-treatment, placebo-controlled, CSF-biomarker-supported trial. Based on interim analysis of the 1-year pre-treatment data, change in the area under the curve of Combinatorial Weight-Adjusted Disability Score (CombiWISE) became the primary outcome, with >80% power to detect ≥40% efficacy with 28 patients/arm treated for 2 years in baseline versus treatment paradigm. Changes in traditional disability scales and in brain ventricular volume were secondary outcomes. Exploratory outcomes included CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning.
RESULTS


Idebenone was well tolerated but did not inhibit disability progression or CNS tissue destruction. Concentrations of GDF15, secreted predominantly by astrocytes and choroid plexus epithelium in vitro, increased after exposure to mitochondrial toxin rotenone, validating the ability of this biomarker to measure intrathecal mitochondrial damage. CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS. Idebenone did not change CSF GDF15 levels.
CONCLUSION


Mitochondrial dysfunction exceeding normal aging reflected by age-adjusted CSF GDF15 is present in the majority of PPMS patients, but it is not inhibited by idebenone.",2020,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","['patients with Primary Progressive MS (IPPoMS', 'primary progressive MS (PPMS']","['Idebenone', 'idebenone', 'placebo']","['Mitochondrial dysfunction', 'traditional disability scales', 'CSF levels of GDF15', 'CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning', 'CSF GDF15 levels', 'Combinatorial Weight-Adjusted Disability Score (CombiWISE', 'disability progression or CNS tissue destruction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0123163', 'cui_str': 'idebenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0020969', 'cui_str': 'Innate Immunity'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}]",,0.0721347,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kosa', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical trials Unit, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Santhera Pharmaceuticals (Switzerland) AG, Pratteln Switzerland.'}, {'ForeName': 'Ruturaj', 'Initials': 'R', 'LastName': 'Masvekar', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wichman', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sandford', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Bielekova', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: Bibi.Bielekova@nih.gov.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102434']
1682,32786188,Compression Therapy to Prevent Recurrent Cellulitis of the Leg.,"BACKGROUND


Chronic edema of the leg is a risk factor for cellulitis. Daily use of compression garments on the leg has been recommended to prevent the recurrence of cellulitis, but there is limited evidence from trials regarding its effectiveness.
METHODS


In this single-center, randomized, nonblinded trial, we assigned participants with chronic edema of the leg and recurrent cellulitis, in a 1:1 ratio, to receive leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group). Follow-up occurred every 6 months for up to 3 years or until 45 episodes of cellulitis had occurred in the trial. The primary outcome was the recurrence of cellulitis. Participants in the control group who had an episode of cellulitis crossed over to the compression group. Secondary outcomes included cellulitis-related hospital admission and quality-of-life assessments.
RESULTS


A total of 183 patients were screened, and 84 were enrolled; 41 participants were assigned to the compression group, and 43 to the control group. At the time of a planned interim analysis, when 23 episodes of cellulitis had occurred, 6 participants (15%) in the compression group and 17 (40%) in the control group had had an episode of cellulitis (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.59; P = 0.002; relative risk [post hoc analysis], 0.37; 95% CI, 0.16 to 0.84; P = 0.02), and the trial was stopped for efficacy. A total of 3 participants (7%) in the compression group and 6 (14%) in the control group were hospitalized for cellulitis (hazard ratio, 0.38; 95% CI, 0.09 to 1.59). Most quality-of-life outcomes did not differ between the two groups. No adverse events occurred during the trial.
CONCLUSIONS


In this small, single-center, nonblinded trial involving patients with chronic edema of the leg and cellulitis, compression therapy resulted in a lower incidence of recurrence of cellulitis than conservative treatment. (Funded by Calvary Public Hospital Bruce; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000412336.).",2020,Most quality-of-life outcomes did not differ between the two groups.,"['Participants in the control group who had an episode of cellulitis crossed over to the compression group', 'A total of 183 patients were screened, and 84 were enrolled; 41 participants', 'participants with chronic edema of the leg and recurrent cellulitis, in a 1:1 ratio, to receive', 'patients with chronic edema of the leg and cellulitis']","['leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group', 'compression therapy', 'Compression Therapy', 'compression garments']","['cellulitis-related hospital admission and quality-of-life assessments', 'Most quality-of-life outcomes', 'adverse events', 'hospitalized for cellulitis', 'recurrence of cellulitis', 'episode of cellulitis']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0333241', 'cui_str': 'Chronic edema'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0742020', 'cui_str': 'Recurrent cellulitis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}]","[{'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",183.0,0.162501,Most quality-of-life outcomes did not differ between the two groups.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Webb', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Neeman', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Bowden', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gaida', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Mumford', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Bissett', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}]",The New England journal of medicine,['10.1056/NEJMoa1917197']
1683,32755419,Blast exposure results in tau and neurofilament light chain changes in peripheral blood.,"OBJECTIVES


To evaluate how blast exposure impacts peripheral biomarkers.
in military personnel enrolled in 10-day blast training.
METHODS


On day 7, 21 military personnel experienced peak overpressure <2 pounds per square inch (psi); while 29 military personnel experienced peak overpressure ≥5 psi. Blood samples were collected each day to measure changes in amyloid beta (Aβ), neurofilament light chain (NFL), and tau concentrations.
RESULTS


Within 24 hours following exposure ≥5 psi, the ≥5 psi group had lower Aβ42 ( p  = .004) and NFL ( p  < .001) compared to the <2 psi group and lower Aβ42 (9.35%) and NFL (22.01%) compared to baseline. Twenty-four hours after ≥5 psi exposure, the ≥5 psi group had lower tau ( p  < .001) and NFL ( p  < .001) compared to the <2 psi group and baseline. Seventy-two hours after exposure ≥5 psi, tau increased in the ≥5 psi group compared to the <2 psi group ( p  = .02) and baseline. The tau:Aβ42 ratio 24 hours after blast ( p  = .012), and the Aβ40:Aβ42 ratio 48 hours after blast ( p  = .04) differed in the ≥5 psi group compared to the <2 psi group.
CONCLUSIONS


These findings provide an initial report of acute alterations in biomarker concentrations following blast exposure.",2020,"The tau:Aβ42 ratio 24 hours after blast ( p  = .012), and the Aβ40:Aβ42 ratio 48 hours after blast ( p  = .04) differed in the ≥5 psi group compared to the <2 psi group.
",['military personnel enrolled in 10-day blast training'],[],"['peripheral blood', 'neurofilament light chain (NFL), and tau concentrations', 'NFL', 'amyloid beta ']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],"[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",,0.0370886,"The tau:Aβ42 ratio 24 hours after blast ( p  = .012), and the Aβ40:Aβ42 ratio 48 hours after blast ( p  = .04) differed in the ≥5 psi group compared to the <2 psi group.
","[{'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Edwards', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Leete', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Tschiffely', 'Affiliation': 'Department of Neurotrauma, Naval Medical Research Center , Silver Spring, MD, USA.'}, {'ForeName': 'Candace Y', 'Initials': 'CY', 'LastName': 'Moore', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Kristine C', 'Initials': 'KC', 'LastName': 'Dell', 'Affiliation': 'Department of Psychology, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Statz', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, MD, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Carr', 'Affiliation': 'Oak Ridge Institute for Science and Education, Oak Ridge, TN, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Walker', 'Affiliation': 'Joint Artificial Intelligence Center, Arlington, VA, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'LoPresti', 'Affiliation': 'Center for Military Psychiatry & Neuroscience, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Ahlers', 'Affiliation': 'Operational & Undersea Medicine Directorate, Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Yarnell', 'Affiliation': 'Operational & Undersea Medicine Directorate, Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}]",Brain injury,['10.1080/02699052.2020.1797171']
1684,32761109,Transfer and retention of oculomotor alignment rehabilitation training.,"Ocular alignment defects such as strabismus affect around 5% of people and are associated with binocular vision impairments. Current nonsurgical treatments are controversial and have high levels of recidivism. In this study, we developed a rehabilitation method for ocular alignment training and examined the rate of learning, transfer to untrained alignments, and retention over time. Ocular alignment was controlled with a real-time dichoptic feedback paradigm where a static fixation target and white gaze-contingent ring were presented to the dominant eye and a black gaze-contingent ring with no fixation target was presented to the nondominant eye. Observers were required to move their eyes to center the rings on the target, with real-time feedback provided by the size of the rings. Offsetting the ring of the nondominant temporal or nasal visual field required convergent or divergent ocular deviation, respectively, to center the ring on the fixation target. Learning was quantified as the time taken to achieve target deviation of 2° (easy, E) or 4° (hard, H) for convergence (CE, CH) or divergence (DE, DH) over 40 trials. Thirty-two normally sighted observers completed two training sequences separated by one week. Subjects were randomly assigned to a training sequence: CE-CH-DE, CH-CE-DE, DE-DH-CE, or DH-DE-CE. The results showed that training was retained over the course of approximately one week across all conditions. Training on an easy deviation angle transferred to untrained hard angles within convergence or divergence but not between these directions. We conclude that oculomotor alignment can be rapidly trained, retained, and transferred with a feedback-based dichoptic paradigm. Feedback-based oculomotor training may therefore provide a noninvasive method for the rehabilitation of ocular alignment defects.",2020,"Learning was quantified as the time taken to achieve target deviation of 2° (easy, E) or 4° (hard, H) for convergence (CE, CH) or divergence (DE, DH) over 40 trials.",[],"['Feedback-based oculomotor training', 'static fixation target and white gaze-contingent ring were presented to the dominant eye and a black gaze-contingent ring with no fixation target', 'training sequence: CE-CH-DE, CH-CE-DE, DE-DH-CE, or DH-DE-CE', 'oculomotor alignment rehabilitation training']","['rate of learning, transfer to untrained alignments, and retention over time']",[],"[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0149007,"Learning was quantified as the time taken to achieve target deviation of 2° (easy, E) or 4° (hard, H) for convergence (CE, CH) or divergence (DE, DH) over 40 trials.","[{'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Walter', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Taveras-Cruz', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bex', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}]",Journal of vision,['10.1167/jov.20.8.9']
1685,32761620,Diagnostic workup including CD203c-based basophil activation test in immediate hypersensitivity due to metronidazole and ornidazole and evaluation of cross-reactivity in between.,"BACKGROUND


Little is known about the diagnostic approaches for immediate hypersensitivity reactions (IHRs) due to 5-nitroimidazole antibiotics. The aim was to evaluate the usefulness of in vivo tests and basophil activation test (BAT) for the diagnosis of IHRs due to metronidazole and ornidazole and to determine possible cross-reactivity in between.
METHODS


Forty-nine patients with a clear history of IHRs due to these drugs and 20 healthy subjects who were known to tolerate these drugs were included. Skin tests (STs) and single-blind placebo-controlled drug provocation tests (SBPCDPTs) were performed with both drugs whereas BAT was applied only with the culprit drug.
RESULTS


The most and least common reaction types were urticaria/angioedema (34.7%) and anaphylaxis (14.3%), respectively. SBPCDPTs were positive in 15 out of 47 patients, and only 7 had positive STs. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of STs for metronidazole/ornidazole were 33.3%/16.6%, 94.2%/97.3%, 60%/50%, and 84.6%/88.1%, respectively. BAT was positive in 12 out of 15 patients and negative in 10 control subjects, giving a sensitivity rate of 71.4% (CI, 29.0%-96.3%) for metronidazole and 83.3% (CI, 35.8%-99.5%) for ornidazole. The optimal concentration of both drugs for BAT was determined as 5 mg/mL. No cross-reactivity among two drugs was observed according to in vivo tests.
CONCLUSIONS


Our study showed that SBPCDPT and BAT are both useful diagnostic tools for IHRs due to 5-nitroimidazole antibiotics and can be used as supplementary to each other. No cross-reactivity between metronidazole and ornidazole in IHRs exists.",2020,"The most and least common reaction types were urticaria/angioedema (34.7%) and anaphylaxis (14.3%), respectively.",['Forty-nine patients with a clear history of IHRs due to these drugs and 20 healthy subjects who were known to tolerate these drugs were included'],"['metronidazole', 'SBPCDPT and BAT', 'basophil activation test (BAT', 'Skin tests (STs), and single-blind placebo-controlled drug provocation tests (SBPCDPTs']","['sensitivity rate', 'urticaria/angioedema', 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of STs for metronidazole/ornidazole', 'BAT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020523', 'cui_str': 'IgE-mediated allergic disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0029274', 'cui_str': 'Ornidazole'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}]",49.0,0.0301092,"The most and least common reaction types were urticaria/angioedema (34.7%) and anaphylaxis (14.3%), respectively.","[{'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Beyaz', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Nilgün', 'Initials': 'N', 'LastName': 'Akdeniz', 'Affiliation': 'Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Demir', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Öztop', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Bahauddin', 'Initials': 'B', 'LastName': 'Çolakoğlu', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Büyüköztürk', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Günnur', 'Initials': 'G', 'LastName': 'Deniz', 'Affiliation': 'Department of Immunology, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Gelincik', 'Affiliation': 'Division of Immunology and Allergic Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}]",Allergy,['10.1111/all.14542']
1686,32761810,Laser-assisted regenerative surgical therapy for peri-implantitis: A randomized controlled clinical trial.,"BACKGROUND


Different surgical approaches have been proposed to treat peri-implantitis defects with limited effectiveness and predictability. Laser has been proposed as an effective tool to assist in bacterial decontamination and modulating peri-implant tissue inflammation. The aim of this pilot clinical trial was to evaluate the adjunctive benefits of Er:YAG laser irradiation for regenerative surgical therapy of peri-implantitis-associated osseous defects.
METHODS


Twenty-four patients diagnosed with peri-implantitis with a radiographic infrabony defect were randomized into two groups. Both test and control groups received the following treatment: open flap mechanical debridement, supracrestal implantoplasty, bone grafting using a mixture of human allograft with demineralized bone matrix human allograft putty, and then covered with acellular dermal matrix membrane. The only difference in the test group was the adjunctive use of Er:YAG laser to modulate and remove inflammatory tissue as well as to decontaminate the implant surface. Clinical assessments, including pocket depth (PD), clinical attachment level (CAL), and gingival index (GI) were performed by calibrated masked examiners for up to 6 months following surgery. Standardized radiographs were also taken to evaluate linear bone gain and defect bone fill. Student t-tests were used to analyze those clinical parameters.
RESULTS


Both groups showed significant reductions in PD, GI, and CAL gain overtime. The test group demonstrated significantly higher PD reductions at the site level compared to the control group (2.65 ± 2.14 versus 1.85 ± 1.71 mm; test versus control, P = 0.014). There were no statistical differences found in CAL gain (1.90 ± 2.28 versus 1.47 ± 1.76 mm; test versus control), GI reduction (-1.14 ± 1.15 versus -1.04 ± 0.89; test versus control), radiographic linear bone gain (1.27 ± 1.14 versus 1.08 ± 1.04 mm; test versus control) or proportional defect size reduction (- 24.46 ± 19.00% versus -15.19 ± 23.56%; test versus control). There was a positive trend for test patients on PD reduction and CAL gain found in narrow infrabony defects. Major membrane exposure negatively impaired the overall treatment outcome of CAL gain (2.47 ± 1.84 versus 1.03 ± 1.48 mm; no/minor versus major exposure, P = 0.051) and PD reduction in the test group (-3.63 ± 2.11 versus -1.66 ± 1.26 mm, P = 0.049).
CONCLUSION


This pilot study indicated using laser irradiation during peri-implantitis regenerative therapy may aid in better probing PD reduction. Nonetheless, a larger sample size and longer follow-up is needed to confirm if Er:YAG laser irradiation provides additional clinical benefits for peri-implantitis regenerative therapy (Clinicaltrials.gov: NCT03127228).",2020,"The test group demonstrated significantly higher PD reductions at the site level compared to the control group (2.65 ± 2.14 vs. 1.85 ± 1.71 mm; test vs. control, p = 0.014).","['Twenty-four patients diagnosed with peri-implantitis with a radiographic infrabony defect', 'peri-implantitis']","['laser irradiation', 'treatment: open flap mechanical debridement, supracrestal implantoplasty, bone grafting using a mixture of human allograft with demineralized bone matrix human allograft putty, and then covered with acellular dermal matrix membrane', 'Laser-assisted regenerative surgical therapy', 'Er:YAG laser irradiation']","['PD reduction', 'pocket depth (PD), clinical attachment level (CAL), and gingival index (GI', 'CAL gain', 'PD, GI, and CAL gain overtime', 'radiographic linear bone gain', 'PD reductions', 'linear bone gain and defect bone fill', 'PD reduction and CAL gain']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C2961731', 'cui_str': 'Overtime'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",24.0,0.10956,"The test group demonstrated significantly higher PD reductions at the site level compared to the control group (2.65 ± 2.14 vs. 1.85 ± 1.71 mm; test vs. control, p = 0.014).","[{'ForeName': 'Chin-Wei', 'Initials': 'CW', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Ashnagar', 'Affiliation': 'Private practice, Dallas, Texas, USA.'}, {'ForeName': 'Riccardo Di', 'Initials': 'RD', 'LastName': 'Gianflippo', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Arnett', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota School of Dentistry, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Kinney', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0040']
1687,32757725,Cognitive and skill performance of individuals at sitting versus standing workstations: a quasi-experimental study.,"Objectives.  This study aimed to assess cognitive and skill performance at sitting and standing workstations among students from Shiraz University of Medical Sciences.  Methods.  Forty students (20 females and 20 males) participated in this quasi-experimental study. Tests were performed among randomly selected participants over two consecutive days: day 1, the Beck depression inventory and Beck anxiety inventory were used to assess the severity of depression and anxiety in the study participants, respectively, and Raven's general intelligence test was used to measure intelligence quotient; day 2, five performance assessment tests (cognitive performance assessment tests ' n -back', 'Stroop' and 'advanced reaction time'; skill performance assessment tests 'two-arm coordination' and 'Purdue pegboard') were randomly selected and presented to individuals at each workstation (sitting and standing workstations). At the end of each sitting and standing position, the comfort of the workstation was measured using a visual analog scale.  Results.  No statistically significant difference was shown between sitting and standing positions in terms of ' n -back', 'Stroop', 'advanced reaction time', 'two-arm coordination' and 'Purdue pegboard'. Participants were more comfortable in sitting positions and more easily distracted in standing positions.  Conclusions.  Sitting and standing positions had no significant effects on participants' cognitive and skill performance.",2020,"The results showed no statistically significant difference between the sitting and standing positions in terms of 'n-back', 'Stroop', 'advanced reaction time', 'two arm coordination', and 'Purdue pegboard'.","['40 students of Shiraz University of Medical Sciences', '40 students (20 females and 20 males) participated']",['Sitting versus Standing Workstations'],"['severity of depression and anxiety', 'visual analogue scale (VAS', 'Cognitive and Skill Performance', 'intelligence quotient (IQ', 'comfortable in sitting positions', ""participants' cognitive and skill performances"", ""sitting and standing positions in terms of 'n-back', 'Stroop', 'advanced reaction time', 'two arm coordination', and 'Purdue pegboard"", 'Beck depression inventory (BDI) and Beck anxiety inventory (BAI', ""performance assessment tests (cognitive performance assessment tests: 'n-back', 'Stroop', and 'advanced reaction time', and skill performance assessment tests: 'two arm coordination', and 'Purdue pegboard"", 'cognitive and skill performances']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",40.0,0.0234461,"The results showed no statistically significant difference between the sitting and standing positions in terms of 'n-back', 'Stroop', 'advanced reaction time', 'two arm coordination', and 'Purdue pegboard'.","[{'ForeName': 'Matin', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'School of Health, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Razeghi', 'Affiliation': 'School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Daneshmandi', 'Affiliation': 'Research Center for Health Sciences, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Hassanzadeh', 'Affiliation': 'School of Health, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Choobineh', 'Affiliation': 'Research Center for Health Sciences, Shiraz University of Medical Sciences, Iran.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2020.1806565']
1688,32757822,Effect of Acupressure on Dynamic Balance in Elderly Women: A Randomized Controlled Trial.,"BACKGROUND


Balance disorders are common in the elderly and are a major cause of falls. This study aimed to determine the effect of acupressure on dynamic balance in elderly women.
METHODS


This randomized controlled clinical trial was conducted on 72 elderly women in Qazvin, Iran. The intervention group received rotary massage using the thumb at the pressure points for 4 weeks, 3 times a week for 20 minutes each session. Dynamic balance in both groups was measured before, 2 and 4 weeks after the intervention using timed up and go test and the step test. Data were analyzed using two way repeated measures ANOVA.
RESULTS


The mean age of participants was 67.34 ± 6.30 with a range of 60 to 80 years old. The results showed statistically significant improvement in the dynamic balance quantified by timed up and go test (%Δ = 26.53) and step test for the right (%Δ = 35.22) and left (Δ% = 32.62) legs ( p  < .001). However, in the control group, no significant change was observed in the dynamic balance after completion of the program.
CONCLUSION


The results support that acupressure therapy can be an effective, safe, and inexpensive method to improve the dynamic balance and maintain maximum autonomy of the elderly.",2020,The results showed statistically significant improvement in the dynamic balance quantified by timed up and go test (%Δ = 26.53) and step test for the right (%Δ = 35.22) and left (Δ% = 32.62) legs ( p  < .001).,"['The mean age of participants was 67.34\xa0±\xa06.30 with a range of 60 to 80\xa0years old', 'Elderly Women', '72 elderly women in Qazvin, Iran', 'elderly women']","['Acupressure', 'rotary massage', 'acupressure', 'acupressure therapy']","['Dynamic balance', 'Dynamic Balance', 'dynamic balance']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",72.0,0.0333272,The results showed statistically significant improvement in the dynamic balance quantified by timed up and go test (%Δ = 26.53) and step test for the right (%Δ = 35.22) and left (Δ% = 32.62) legs ( p  < .001).,"[{'ForeName': 'Seyedeh Ameneh', 'Initials': 'SA', 'LastName': 'Motalebi', 'Affiliation': 'Social Determinants of Health Research Center (SDH), Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Zajkani', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Social Determinants of Health Research Center (SDH), Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Habibi', 'Affiliation': 'Irannian Scientific Accupancture , Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mafi', 'Affiliation': 'School of Nursing and Midwifery, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ranjkesh', 'Affiliation': 'Children Growth Research Center, Research Institute for Prevention of Non Communicable Diseases, Qazvin University of Medical Sciences , Qazvin, Iran.'}]",Experimental aging research,['10.1080/0361073X.2020.1802981']
1689,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
1690,32758677,Inspiratory neural drive and dyspnea in interstitial lung disease: Effect of inhaled fentanyl.,"BACKGROUND


Exertional dyspnea in interstitial lung disease (ILD) remains difficult to manage despite advances in disease-targeted therapies. Pulmonary opioid receptors present a potential therapeutic target for nebulized fentanyl to provide dyspnea relief.
METHODS


ILD patients were characterized with reference to healthy volunteers. A randomized, double-blind, placebo-controlled crossover comparison of 100 mcg nebulized fentanyl vs placebo on dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise was performed in 21 ILD patients.
RESULTS


Dyspnea intensity in ILD increased in association with an increase in IND (diaphragm activation) from a high resting value of 16.66 ± 6.52 %-60.04 ± 12.52 % of maximum (r = 0.798, p < 0.001). At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
CONCLUSION


IND rose sharply during constant work rate exercise in association with dyspnea intensity in mild to moderate ILD but was not different after nebulized fentanyl compared with placebo.",2020,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","['ILD patients were characterized with reference to healthy volunteers', 'interstitial lung disease', '21 ILD patients']","['inhaled fentanyl', '100 mcg nebulized fentanyl vs placebo', 'nebulized fentanyl', 'fentanyl vs placebo', 'placebo']","['IND responses', 'IND (diaphragm activation', 'dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise', 'dyspnea intensity ratings', 'Inspiratory neural drive and dyspnea']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",21.0,0.334941,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada; Clinician Investigator Program, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Ibrahim-Masthan', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Moran-Mendoza', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'Neder', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada. Electronic address: odonnell@queensu.ca.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103511']
1691,32759888,Elevated Lateral Position Improves the Success of Paramedian Approach Subarachnoid Puncture in Spinal Anesthesia before Hip Fracture Surgery in Elderly Patients: A Randomized Controlled Study.,"BACKGROUND The aim of this study was to determine whether an elevated lateral recumbent position, compared to regular lateral recumbent position, may reduce the number of needle passes and attempts required for success subarachnoid puncture in spinal aesthesia before surgery in elderly patients with hip fractures. MATERIAL AND METHODS This was a randomized controlled interventional study in Beijing Jishuitan Hospital. Patients older than 65 years of age with hip fracture orthopedics who were planned to receive subarachnoid block in the lateral recumbent position before surgery were enrolled. The eligible patients were randomly allocated into the experimental group, in which a lateral recumbent position with head and chest elevated 30° was taken during subarachnoid puncture. In the control group, subarachnoid puncture was performed in the lateral recumbent position. The main outcome was the numbers of needle passes required for a success puncture. Other outcomes included success rate in different numbers of attempts, patients reported discomfort score, and complications. RESULTS A total of 90 patients were enrolled, with 45 patients in each group. The number of needle passes (2.00 versus 3.00, P=0.001) and the number of attempts (1.00 versus 2.00, P<0.001) required for a successful subarachnoid puncture were significantly less in the experimental group than in the control group. Patients in the experimental group also had lower discomfort scores. The procedure process, including overall times needed for puncture, anesthesia, and surgery did not show differences between the 2 groups. Complications were few and similar between the 2 groups. CONCLUSIONS An elevated lateral recumbent position during the subarachnoid puncture in spinal anesthesia significantly reduced the needle pass numbers needed for success dural puncture, and reduced discomfort in elderly patients with hip fractures.",2020,"The procedure process, including overall times needed for puncture, anesthesia, and surgery did not show differences between the 2 groups.","['Beijing Jishuitan Hospital', 'Elderly Patients', 'elderly patients with hip fractures', '90 patients were enrolled, with 45 patients in each group', 'Patients older than 65 years of age with hip fracture orthopedics who were planned to receive subarachnoid block in the lateral recumbent position before surgery were enrolled']","['lateral recumbent position with head and chest elevated 30° was taken during subarachnoid puncture', 'Spinal Anesthesia before Hip Fracture Surgery']","['discomfort scores', 'number of attempts', 'numbers of needle passes required for a success puncture', 'number of needle passes', 'successful subarachnoid puncture', 'Complications', 'success rate', 'overall times needed for puncture, anesthesia, and surgery', 'discomfort score, and complications', 'subarachnoid puncture']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",90.0,0.11917,"The procedure process, including overall times needed for puncture, anesthesia, and surgery did not show differences between the 2 groups.","[{'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China (mainland).'}, {'ForeName': 'Tianlong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, China (mainland).'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China (mainland).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China (mainland).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China (mainland).'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China (mainland).'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Beijing Jishuitan Hospital, Beijing, China (mainland).'}, {'ForeName': 'Shaoqiang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923813']
1692,32767879,[Comparative study of anterior cruciate ligament reconstruction between the One Band and U-Two techniques].,"INTRODUCTION


ACL injuries are found within the most common ligament injuries. This has led to the development of different surgical techniques to restore knee stability.
MATERIAL Y METHODS


Clinical study, randomized, blind comparing ACL reconstruction techniques with One Band and «U-Two» using clinical scales and arthrometria with KT-1000 and Pivot Shift Meter.
RESULTS


Of 36 patients, 52.94% was drawn for the One Band technique and 47.06% for «U-Two». 11.76% of patients had a displacement greater than 11mm in the affected knee with KT-1000. 8.82% showed an equal anterior displacement on both knees. One patient had a major previous displacement after reconstruction surgery with the one band technique, but with improvement on clinical scales. Pivot Shift measurements found a difference in displacement greater than 4,000 m/s on the X axis following the One Band technique compared to the healthy knee calculating integrals, while with U-Two the difference was less than 600 m/s. On the Y axis a difference of 3,500 m/s was found between the healthy and the injured leg, which decreases to less than 2,000 m/s after reconstruction using U-Two technique.
CONCLUSIONS


Differences have been found throughout the study in patient evolution, indicating that repair using the U-Dos technique has better results in recovering the anteroposterior and rotational stability of the affected limb.",2019,"On the Y axis a difference of 3,500 m/s was found between the healthy and the injured leg, which decreases to less than 2,000 m/s after reconstruction using U-Two technique.
",[],"['ACL reconstruction techniques with One Band and «', 'anterior cruciate ligament reconstruction']",['clinical scales'],[],"[{'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0168216,"On the Y axis a difference of 3,500 m/s was found between the healthy and the injured leg, which decreases to less than 2,000 m/s after reconstruction using U-Two technique.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Berumen-Nafarrate', 'Affiliation': 'Ortopedia y Traumatología, Hospital Christus Muguerza del Parque. Chihuahua, Chihuahua. México.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carmona-González', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Tonche-Ramos', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Carmona-Máynez', 'Affiliation': 'Ortopedia y Traumatología, Hospital Christus Muguerza del Parque. Chihuahua, Chihuahua. México.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aguirre-Madrid', 'Affiliation': 'Ortopedia y Traumatología, Hospital Christus Muguerza del Parque. Chihuahua, Chihuahua. México.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moreno-Brito', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Leal-Berumen', 'Affiliation': 'Facultad de Medicina y Ciencias Biomédicas, Universidad Autónoma de Chihuahua. México.'}]",Acta ortopedica mexicana,[]
1693,32762427,"Medication use, renin-angiotensin system inhibitors, and acute care utilization after hospitalization in patients with chronic kidney disease.","OBJECTIVES


The aims of this secondary analysis were to: (a) characterize medication use following hospital discharge for patients with chronic kidney disease (CKD), and (b) investigate relationships of medication use with the primary composite outcome of acute care utilization 90 days after hospitalization.
METHODS


The CKD-Medication Intervention Trial (CKD-MIT) enrolled acutely ill hospitalized patients with CKD stages 3-5 not dialyzed (CKD 3-5 ND). In this post hoc analysis, data for medication use were characterized, and the relationship of medication use with the primary outcome was evaluated using Cox proportional hazards models.
RESULTS


Participants were taking a mean of 12.6 (standard deviation=5.1) medications, including medications from a wide variety of medication classes. Nearly half of study participants were taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB). ACE inhibitor/ARB use was associated with decreased risk of the primary outcome (hazard ratio=0.51; 95% confidence interval 0.28-0.95;  p =0.03) after adjustment for baseline estimated glomerular filtration rate, age, sex, race, blood pressure, albuminuria, and potential nephrotoxin use.
CONCLUSIONS


A large number, variety, and complexity of medications were used by hospitalized patients with CKD 3-5 ND. ACE inhibitor or ARB use at hospital discharge was associated with a decreased risk of 90-day acute care utilization.",2020,"ACE inhibitor/ARB use was associated with decreased risk of the primary outcome (hazard ratio=0.51; 95% confidence interval 0.28-0.95;  p =0.03) after adjustment for baseline estimated glomerular filtration rate, age, sex, race, blood pressure, albuminuria, and potential nephrotoxin use.
","['acutely ill hospitalized patients with CKD stages 3-5 not dialyzed (CKD 3-5 ND', 'Participants were taking a mean of 12.6 (standard deviation=5.1) medications, including medications from a wide variety of medication classes', 'patients with chronic kidney disease', 'patients with chronic kidney disease (CKD), and (b) investigate relationships of medication use with the primary composite outcome of acute care utilization 90 days after hospitalization']","['ACE inhibitor or ARB', 'renin-angiotensin system inhibitors', 'ACE inhibitor/ARB', 'angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB']",[],"[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}]",[],,0.0473132,"ACE inhibitor/ARB use was associated with decreased risk of the primary outcome (hazard ratio=0.51; 95% confidence interval 0.28-0.95;  p =0.03) after adjustment for baseline estimated glomerular filtration rate, age, sex, race, blood pressure, albuminuria, and potential nephrotoxin use.
","[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Neumiller', 'Affiliation': 'College of Pharmacy and Pharmaceutical Sciences, Washington State University, USA.'}, {'ForeName': 'Kenn B', 'Initials': 'KB', 'LastName': 'Daratha', 'Affiliation': 'School of Anesthesia, Providence Health Care, USA.'}, {'ForeName': 'Radica Z', 'Initials': 'RZ', 'LastName': 'Alicic', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Short', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}, {'ForeName': 'Haleigh M', 'Initials': 'HM', 'LastName': 'Miller', 'Affiliation': 'Sacred Heart Medical Center, Providence Health Care, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Gregg', 'Affiliation': 'Sacred Heart Medical Center, Providence Health Care, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gates', 'Affiliation': 'College of Pharmacy and Pharmaceutical Sciences, Washington State University, USA.'}, {'ForeName': 'Cynthia F', 'Initials': 'CF', 'LastName': 'Corbett', 'Affiliation': 'College of Nursing, University of South Carolina, USA.'}, {'ForeName': 'Sterling M', 'Initials': 'SM', 'LastName': 'McPherson', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, USA.'}]",Journal of the renin-angiotensin-aldosterone system : JRAAS,['10.1177/1470320320945137']
1694,32763217,"Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial.","BACKGROUND


Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest. We did nested pharmacokinetic substudies in patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV.
METHODS


We did pharmacokinetic and safety substudies within the open-label, multicentre, randomised ODYSSEY trial (NCT02259127) of children with HIV starting treatment in four research centres in Uganda and Zimbabwe. Eligible children were randomised to dolutegravir in ODYSSEY and weighed 20 kg to less than 40 kg. In children weighing 20 kg to less than 25 kg, we assessed dolutegravir's pharmacokinetics in children given once daily 25 mg film-coated tablets (approved by the SRAs at the time of the study) in part one of the study, and 50 mg film-coated tablets (adult dose) or 30 mg dispersible tablets in part two of the study. In children weighing 25 kg to less than 40 kg, we also assessed dolutegravir pharmacokinetics within-subject on film-coated tablet doses of 25 mg or 35 mg once daily, which were approved by the SRAs for the children's weight band; then switched to 50 mg film-coated tablets once daily. Steady-state 24 h dolutegravir plasma concentration-time pharmacokinetic profiling was done in all enrolled children at baseline and 1, 2, 3, 4, 6, and 24 h after observed dolutegravir intake. Target dolutegravir trough concentrations (C trough ) were based on reference adult pharmacokinetic data and safety was evaluated in all children in the corresponding weight bands who consented to pharmacokinetic studies and received the studied doses.
FINDINGS


Between Sept 22, 2016, and May 31, 2018, we enrolled 62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles). In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32 mg/L (94%), which was 61% lower than the GM C trough  of 0·83 mg/L (26%) in fasted adults on dolutegravir 50 mg once-daily; in children weighing 25 kg to less than 30 kg taking 25 mg film-coated tablets, the GM C trough  was 0·39 mg/L (48%), which was 54% lower than the GM C trough  in fasted adults; and in those 30 kg to less than 40 kg taking 35 mg film-coated tablets the GM C trough  was 0·46 mg/L (63%), which was 45% lower than the GM C trough  in fasted adults. On 50 mg film-coated tablets or 30 mg dispersible tablets, C trough  was close to the adult reference (with similar estimates on the two formulations in children in the 20 to <25 kg weight band), with total exposure (area under the concentration-time curve from 0 h to 24 h) in between reference values in adults dosed once and twice daily, where safety data are reassuring, although maximum concentrations were higher in children weighing 20 kg to less than 25 kg than in the twice-daily adult reference. Over a 24-week follow-up period in 47 children on 30 mg dispersible tablets or 50 mg film-coated tablets, none of the three reported adverse events (cryptococcal meningitis, asymptomatic anaemia, and asymptomatic neutropenia) were considered related to dolutegravir.
INTERPRETATION


Adult dolutegravir 50 mg film-coated tablets given once daily provide appropriate pharmacokinetic profiles in children weighing 20 kg or more, with no safety signal, allowing simplified practical dosing and rapid access to dolutegravir. These results informed the WHO 2019 dolutegravir paediatric dosing guidelines and have led to US Food and Drug Administration approval of adult dosing down to 20 kg.
FUNDING


Paediatric European Network for Treatment of AIDS Foundation, ViiV Healthcare, UK Medical Research Council.",2020,"In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32","['62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles', 'children with HIV weighing 20 kg or more', '47 children', 'Between Sept 22, 2016, and May 31, 2018', 'patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV', 'Eligible children', 'children with HIV starting treatment in four research centres in Uganda and Zimbabwe']",[],"[""dolutegravir's pharmacokinetics"", 'dolutegravir pharmacokinetics', 'adverse events (cryptococcal meningitis, asymptomatic anaemia, and asymptomatic neutropenia']","[{'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}]",[],"[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",62.0,0.226703,"In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32","[{'ForeName': 'Pauline D J', 'Initials': 'PDJ', 'LastName': 'Bollen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Moore', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Hilda A', 'Initials': 'HA', 'LastName': 'Mujuru', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Shafic', 'Initials': 'S', 'LastName': 'Makumbi', 'Affiliation': 'Joint Clinical Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Adeodata R', 'Initials': 'AR', 'LastName': 'Kekitiinwa', 'Affiliation': ""Baylor College of Medicine Children's Foundation, Kampala, Uganda.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kaudha', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Musoro', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Nanduudu', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Lugemwa', 'Affiliation': 'Joint Clinical Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Amuge', 'Affiliation': ""Baylor College of Medicine Children's Foundation, Kampala, Uganda.""}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rojo', 'Affiliation': 'Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Giaquinto', 'Affiliation': 'University of Padova, Padova, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands. Electronic address: angela.colbers@radboudumc.nl.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ford', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Turkova', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30189-2']
1695,32763640,Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness.,"BACKGROUND


Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, including ICU-related post-traumatic stress disorder (PTSD), depression and anxiety. As we encounter a growing number of ICU survivors, in particular in the wake of the coronavirus pandemic, clinicians must be equipped to understand the severity and prevalence of significant psychiatric complications of critical illness.
METHODS


We compared the efficacy of the ICU diary, written by family and healthcare workers during the patient's intensive care course, versus education alone in reducing acute PTSD symptoms after discharge. Patients with an ICU stay >72 h, who were intubated and mechanically ventilated over 24 h, were recruited and randomized to either receive a diary at bedside with psychoeducation or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7 was conducted at baseline within 1 week of ICU discharge and at weeks 4, 12, and 24 after ICU discharge. Change from baseline in these scores was assessed using Wilcoxon rank sum tests.
RESULTS


From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital. 60 patients were enrolled and randomized, of which 35 patients completed post-discharge follow-up, (n = 18) in the diary intervention group and (n = 17) in the education-only control group. The control group had a significantly greater decrease in PTSD, hyperarousal, and depression symptoms at week 4 compared to the intervention group. There were no significant differences in other measures, or at other follow-up intervals. Both study groups exhibited clinically significant PTSD symptoms at all timepoints after ICU discharge. Follow-up phone interviews with patients revealed that while many were interested in getting follow-up for their symptoms, there were many barriers to accessing appropriate therapy and clinical attention.
CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay. However, our study finds an important gap in clinical practice - patients at high risk for PICS are infrequently connected to appropriate follow-up care. Perhaps ICU diaries would prove beneficial if utilized to support the work within a program providing wrap-around services and close psychiatric follow up for PICS patients. This study demonstrates the high prevalence of ICU-related PTSD in our cohort of survivors, the high barrier to accessing care for appropriate treatment of PICS, and the consequence of that barrier-prolonged psychological morbidity.
TRIAL REGISTRATION


NCT04305353.
GRANT IDENTIFICATION


GH-17-022 (Arnold P. Gold Foundation).",2020,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","['From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital', '60 patients', 'Patients with an ICU stay >72\u202fh, who were intubated and mechanically ventilated over 24\u202fh']","['intensive care unit (ICU) diary program', 'diary intervention group and (n\u202f=\u202f17) in the education-only control group', 'diary at bedside with psychoeducation or psychoeducation alone']","['acute PTSD symptoms', 'PTSD symptoms', 'PTSD, hyperarousal, and depression symptoms', 'Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0747767', 'cui_str': 'Acute Post-Traumatic Stress Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}]",60.0,0.0503067,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","[{'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Sayde', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: gsayde@tulane.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Stefanescu', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, 1440 Canal Street, New Orleans, LA 70122, USA. Electronic address: astefanescu@tulane.edu.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Conrad', 'Affiliation': 'Department of Psychiatry, Louisiana State University, 2025 Gravier Street, New Orleans, LA 70112, USA. Electronic address: econra@lsuhsc.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of New Mexico School of Medicine, 1 University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hammer', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: rhammer@tulane.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.017']
1696,32763649,"Parenting, mental health and economic pathways to prevention of violence against children in South Africa.","BACKGROUND


Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.
METHODS


The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.
RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.
CONCLUSIONS


Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.",2020,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","['rural South Africa with 40 sites, n\xa0=\xa0552 family dyads (including adolescents aged 10-18 and primary caregivers', 'reduced violence against children', 'Emotional and physical violence against children/adolescents', 'violence against children in South Africa', 'violence against children']","['brief informational workshop', '14-session parenting program delivered by local community members, including modules on family budgeting and savings']","['violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare', 'parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening', 'child behaviour']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",552.0,0.117351,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Institute of Criminology, University of Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meinck', 'Affiliation': 'School of Social and Political Science, University of Edinburgh, United Kingdom; Optentia, Faculty of Health Sciences, North-West University, South Africa. Electronic address: Franziska.Meinck@ed.ac.uk.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Berezin', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Applied Psychology, New York University, New York, USA. Electronic address: mnb387@nyu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Doubt', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: jennydoubt@gmail.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa. Electronic address: Catherine.Ward@uct.ac.za.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parra-Cardona', 'Affiliation': 'Steve Hicks School of Social Work, The University of Texas at Austin, Texas, USA. Electronic address: rparra@austin.utexas.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, South Africa. Electronic address: carl.lombard@mrc.ac.za.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; MRC/CSO Social and Public Health Sciences Unit, University of Glasglow, United Kingdom. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wittesaele', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: camille.wittesaele@spi.ox.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychology, University of Cape Town, South Africa. Electronic address: inge.wessels@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: frances.gardner@wolfson.ox.ac.uk.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; TUM School of Governance, Technical University of Munich, Germany. Electronic address: janina.steinert@tum.de.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113194']
1697,32763776,Effect of brief encouragement to use twitter on knowledge of the critical-care literature by ICU residents: The randomized controlled IMKREASE trial.,,2020,,['ICU residents'],[],[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],[],,0.0232695,,"[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jeanbaptiste.lascarrou@chu-nantes.fr.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Tours, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Potier', 'Affiliation': 'Department of internal medicine, University Hospital Center, Nantes, France. Electronic address: pierre.potier@chu-nantes.fr.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reignier', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jean.reignier@chu-nantes.fr.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Canet', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: emmanuel.canet@chu-nantes.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.07.022']
1698,32763873,Comparing a Mobile Phone Automated System With a Paper and Email Data Collection System: Substudy Within a Randomized Controlled Trial.,"BACKGROUND


Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes.
OBJECTIVE


The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women.
METHODS


We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods.
RESULTS


Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; P<.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; P<.001) and a higher recommendation rate for future use (95% vs 64%; P<.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable.
CONCLUSIONS


MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.",2020,"A mobile phone automated system is an effective and acceptable method for improving the overall management, treatment compliance and methodological quality of clinical research to ensure validity and reliability of findings.
","['555 women: 471 using the MPAS and 84 the PEDC', 'Women were recruited between April 2015 and December 2016', 'a cohort of breastfeeding women', 'Sydney, Australia which included women with uncomplicated term births who intended to breastfeed', 'Women were recruited within 72 hours of birth']","['PEDC', 'web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC', 'mobile phone automated system with a paper and email data collection system']","['effectiveness of data collection, impact on study outcomes, response rate, acceptability and cost analysis between the MPAS and PEDC methods', 'response rate', 'rate of self-reported treatment compliance', 'clinical outcomes']","[{'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3887707', 'cui_str': 'Data Collection Methods'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",555.0,0.169899,"A mobile phone automated system is an effective and acceptable method for improving the overall management, treatment compliance and methodological quality of clinical research to ensure validity and reliability of findings.
","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Bond', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Hammond', 'Affiliation': 'Strategic Ventures, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Antonia W', 'Initials': 'AW', 'LastName': 'Shand', 'Affiliation': ""Children's Hospital at Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Nassar', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}]",JMIR mHealth and uHealth,['10.2196/15284']
1699,32758689,"SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.","BACKGROUND


The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial.
METHODS


In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance.
RESULTS


Novaferon inhibited viral replication (EC 50 =1.02ng/ml), and prevented viral infection (EC 50 =0.10ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p=0.0400, and 60.0% vs. 24.1%, p=0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group.
CONCLUSIONS


Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon.
TRIAL REGISTRATION NUMBER


Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).",2020,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","['COVID-19 patients with treatment of Novaferon', 'COVID-19 Patients with Novaferon Treatment']","['Lopinavir/Ritonavir', 'Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir', 'Novaferon', '6than Lopinavir/Ritonavir']","['viral infection', 'SARS-CoV-2 Clearance', 'Median time to viral clearance', 'viral replication', 'SARS-CoV-2 clearance rates', 'time to SARS-CoV-2 clearance', 'viral clearance rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",89.0,0.111733,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yaxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Internal Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Niu', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: jiangyongfang@csu.edu.cn.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China. Electronic address: 1286779459@qq.com.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: gongguozhong@csu.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.053']
1700,32762590,Communicating value to patients-a high-value care communication skills curriculum.,"INTRODUCTION


With rising health care costs in the United States, trainees will be increasingly challenged in discussing testing stewardship with patients.
OBJECTIVE


We piloted a high-value care (HVC) communication skills curriculum utilizing the Four Habits Model for communication. We hoped residents would 1) learn to apply the Four Habits communication model to HVC discussions with standardized patients (SP) and 2) improve value-based communication skills through training in a high-intensity curriculum with feedback from trained faculty facilitators and peers.
METHODS


Thirty interns at the University of Minnesota were randomized to a standard HVC communication SP encounter (n = 15) or a high-intensity HVC communication skills curriculum (n = 15). The high-intensity curriculum included video and audio-recorded SP encounters followed by facilitated small group discussions/feedback. Experiences were reported in a post-intervention survey; communication skills were assessed with the CARE empathy scale.
RESULTS


70% (21/30) of interns (57% high intensity, 43% standard) responded to the survey. In total, 88% of high intensity v. 44% of standard interns agreed/strongly agreed that the curriculum was valuable for their communication skills. High-intensity interns were more likely to report that feedback was valuable with subsequent incorporation of feedback into future patient encounters. High-intensity participants also reported higher levels of interest in future HVC curricula (55% vs 22%).
CONCLUSION


There was no difference in overall performance on the CARE empathy scale. Our HVC high-intensity skills curriculum was well received by interns and provided opportunities to practice structured conversations and debrief around testing stewardship.",2020,88% of high intensity v. 44% of standard interns agreed/strongly agreed that the curriculum was valuable for their communication skills.,['Thirty interns at the University of Minnesota'],['standard HVC communication SP encounter (n=15) or a high intensity HVC communication skills curriculum'],"['CARE empathy scale', 'overall performance on the CARE empathy scale']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0332911,88% of high intensity v. 44% of standard interns agreed/strongly agreed that the curriculum was valuable for their communication skills.,"[{'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': ""Section of Women's Health and General Internal Medicine, Minneapolis VA Health Care System, University of Minnesota , Minneapolis, MN, USA.""}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Donelan', 'Affiliation': 'Department of Emergency Medicine, George Washington University , Washington D.C., USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bowman Peterson', 'Affiliation': 'Department of Medicine, University of Minnesota , Minneapolis, MN, USA.'}, {'ForeName': 'Sophia P', 'Initials': 'SP', 'LastName': 'Gladding', 'Affiliation': 'Department of Medicine, University of Minnesota , Minneapolis, MN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Weissmann', 'Affiliation': 'Department of Medicine, University of Minnesota , Minneapolis, MN, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of Minnesota , Minneapolis, MN, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1807728']
1701,32766757,Long-Term Glycemic Variability and Vascular Complications in Type 2 Diabetes: Post Hoc Analysis of the FIELD Study.,"AIMS


To investigate whether long-term glycemic variability (GV) is associated with vascular complication development in type 2 diabetes.
METHODS


In a post hoc FIELD trial analysis, GV was calculated as the standard deviation and coefficient of variation (CV) of glycated hemoglobin A1c (HbA1c) and fasting plasma glucose. Baseline variables were compared across quartiles of on-study variability by chi square and ANOVA. Prospective associations between baseline to 2-year GV and subsequent vascular and mortality outcomes were analyzed using landmark logistic and Cox proportional hazards regression.
RESULTS


Baseline factors associated with higher on-study GV included younger age, male gender, longer diabetes duration, and higher pharmacological therapies usage. Both HbA1c and fasting glucose CV were associated with increased risk of microvascular complications (HR 1.02 [95% CI, 1.01-1.03] P < 0.01; and HR 1.01 [95% CI, 1.00-1.01] P < 0.001, respectively). HbA1c and fasting glucose CV were associated with increased cardiovascular disease (HR 1.02 [95% CI, 1.00-1.04]; and HR 1.01 [95% CI, 1.00-1.02], both P < 0.05). HbA1c CV associated with increased stroke (HR 1.03 [95% CI, 1.01-1.06) P < 0.01). Glucose CV associated with increased coronary events (HR 1.01 [95% CI, 1.00-1.02] P < 0.05). Both HbA1c and glucose CV associated with increased total mortality (HR 1.04 [95% CI, 1.02-1.06]; and HR 1.01 [95% CI, 1.01-1.02], both P < 0.001) and noncardiovascular mortality (HR 1.05 [95% CI, (1.03-1.07]; and HR 1.02 [95% CI, 1.01-1.03], both P < 0.001). HbA1c CV associated with coronary mortality (HR 1.04 [95% CI, 1.01-1.07] P < 0.05).
CONCLUSIONS


Long-term GV was associated with increased risk of vascular outcomes in type 2 diabetes.",2020,"HbA1c and fasting glucose CV were associated with increased cardiovascular disease (HR 1.02 (95% CI 1.00-1.04); HR 1.01 (95% CI 1.00-1.02), both p<0.05).",['Type 2 diabetes'],['long-term glycaemic variability (GV'],"['Glucose CV associated with increased coronary events', 'cardiovascular disease', 'risk of vascular outcomes', 'stroke', 'total mortality', 'HbA1c and fasting glucose CV', 'non-cardiovascular mortality', 'standard deviation and coefficient of variation (CV) of HbA1c and fasting plasma glucose', 'coronary mortality', 'risk of microvascular complications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.264684,"HbA1c and fasting glucose CV were associated with increased cardiovascular disease (HR 1.02 (95% CI 1.00-1.04); HR 1.01 (95% CI 1.00-1.02), both p<0.05).","[{'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Scott', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrzej S', 'Initials': 'AS', 'LastName': 'Januszewski', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Connell"", 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Department of Endocrinology and Diabetes, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Scott', 'Affiliation': 'Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Antero', 'Initials': 'A', 'LastName': 'Kesaniemi', 'Affiliation': 'Oulu Medical Research Centre, University of Oulu and Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Colagiuri', 'Affiliation': 'The Boden Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa361']
1702,32768592,Efficacy and safety of basiliximab as initial immunosuppression in liver transplantation: A single center study.,"INTRODUCTION AND AIM


The interleukin-2 receptor antagonist; basiliximab is used to allow delayed introduction of Calcineurin inhibitors (CNI) after liver transplantation and thus delay their renal insult. However, there is only little evidence for the safety and the efficacy of this regimen. This study aimed to evaluate the effectiveness and safety of basiliximab induction in liver transplantation.
MATERIALS AND METHODS


This study included 89 patients who were classified into two groups: standard triple immunosuppression (IS) regimen of steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF) (n = 47) and induction IS regimen of basiliximab, low dose steroids and MMF with delayed introduction of CNI (n = 42). All patients were followed after liver transplantation for at least six months or until death.
RESULTS


There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups. The acute rejection rate was equivalent in both groups. Renal dysfunction in the first six months post-transplant was less in the basiliximab group in comparison to the other group (7.1% and 19.1% respectively).
CONCLUSION


Basiliximab-induced IS protocol is a safe regimen that reduces medium-term renal dysfunction and achieves similar survival without increasing the acute rejection or infection rate in liver transplantation recipients.",2020,"There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups.","['liver transplantation recipients', '89 patients who were classified into two groups', 'Liver Transplantation']","['interleukin-2 receptor antagonist', 'Basiliximab', 'standard triple immunosuppression (IS) regimen of steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF) (n\u2009=\u200947) and induction IS regimen of basiliximab, low dose steroids and MMF with delayed introduction of CNI', 'Basiliximab-induced IS protocol']","['Efficacy and Safety', 'Renal dysfunction', 'acute rejection rate', 'patient survival, graft dysfunction, infection rate or type, or wound healing']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",89.0,0.0258293,"There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hashim', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt. Electronic address: msaadhh@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Alsebaey', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ragab', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Hossam Eldeen', 'Initials': 'HE', 'LastName': 'Soliman', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Imam', 'Initials': 'I', 'LastName': 'Waked', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}]",Annals of hepatology,['10.5604/01.3001.0012.2246']
1703,32768597,Reply to letter to the editor: 'effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands - a randomized controlled trial'.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.0830795,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pelle', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: T.Pelle@maartenskliniek.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bevers', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Research Methodology, Measurement, and Data-Analysis, Behavioural, Management and Social Sciences, University of Twente, Enschede, the Netherlands; Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'F H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'C H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.07.007']
1704,32768599,Commentary on: effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands; a randomized controlled trial.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.10498,,"[{'ForeName': 'S F J', 'Initials': 'SFJ', 'LastName': 'Chudy', 'Affiliation': 'Erasmus MC, Netherlands. Electronic address: stanchudy@gmail.com.'}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Volwater', 'Affiliation': 'Leiden University, Netherlands. Electronic address: mike_volwater@hotmail.com.'}, {'ForeName': 'Ö F', 'Initials': 'ÖF', 'LastName': 'Ozbulut', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: o.ozbulut@erasmusmc.nl.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: b.koes@erasmusmc.nl.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.06.011']
1705,32769506,Oral fluid intake during the first stage of labour: A randomised trial.,"BACKGROUND


Obstetric anaesthesia has been associated with concern for the inhalation of gastric contents for many years, justifying fasting during labour. However, many anaesthesiologists and obstetricians now allow fluid intake during labour.
OBJECTIVE(S)


We hypothesised that allowing oral fluid intake during labour is not associated with increased gastric contents. We used ultrasound assessment of gastric contents to evaluate this hypothesis.
DESIGN


A randomised, single-blind and intention-to-treat noninferiority trial comparing antral area measured by ultrasound in fasting parturients and in those who were allowed to drink fluid for 90 min after randomisation.
SETTING


Tenon University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
PATIENTS


Pregnant women, aged from 18 to 40 years and from week 36 of an uncomplicated singleton gestation, were randomised into a fasting group and a fluid intake group after admission to the delivery room. Of the 184 patients screened, data from 125 were analysed: fasting group (62), fluid intake group (63).
INTERVENTION


Women in the fluid intake group were allowed to drink up to 400 ml of apple juice for 90 min after randomisation.
MAIN OUTCOME MEASURE


We compared the percentage of women with an 'empty stomach' between the two groups: empty stomach was defined as an antral cross-sectional area (CSA) less than 300 mm assessed in a semirecumbent position with a 45-degree head-up tilt.
RESULTS


At full cervical dilatation an antral CSA less than 300 mm was measured in 76 and 79% of the parturients in the fasting group and the fluid intake groups respectively (P = 0.633).
CONCLUSION


The current study reveals that the percentage of pregnant women with an 'empty stomach', defined by an antral CSA less than 300 mm in a semirecumbent position with a 45-degree head-up tilt, was comparable at full cervical dilation among those who remained nil by mouth and those allowed to drink up to 400 ml for 90 min after their randomisation.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02362815.",2020,"At full cervical dilatation an antral CSA less than 300 mm was measured in 76 and 79% of the parturients in the fasting group and the fluid intake groups respectively (P = 0.633).
","['184 patients screened, data from 125 were analysed: fasting group (62), fluid intake group (63', 'Tenon University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France', ""pregnant women with an 'empty stomach"", 'Pregnant women, aged from 18 to 40 years and from week 36 of an uncomplicated singleton gestation', ""women with an 'empty stomach' between the two groups: empty stomach was defined as an antral cross-sectional area (CSA) less than 300\u200amm assessed in a semirecumbent position with a 45-degree head-up tilt"", 'first stage of labour', 'fasting parturients and in those who were allowed to drink fluid for 90\u200amin after randomisation']","['fasting group and a fluid intake group after admission to the delivery room', 'drink up to 400\u200aml of apple juice']",['Oral fluid intake'],"[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}]","[{'cui': 'C0429648', 'cui_str': 'Quantity of drinking'}]",,0.217113,"At full cervical dilatation an antral CSA less than 300 mm was measured in 76 and 79% of the parturients in the fasting group and the fluid intake groups respectively (P = 0.633).
","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Rousset', 'Affiliation': 'From the Department of Anaesthesiology and Perioperative Medicine, Hôpital Tenon (JR, SC, FT, JB, EMH, CQ, FB), Biostatistics Department, Hôpital Saint Louis-Lariboisière, Assistance Publique Hôpitaux de Paris (EF), Faculty of Medicine Paris VI, Sorbonne University (CQ, FB) and Department of Anaesthesiology, Hôpital Foch, Paris, France (MF).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clariot', 'Affiliation': ''}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Tounou', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Burey', 'Affiliation': ''}, {'ForeName': 'El M', 'Initials': 'EM', 'LastName': 'Hafiani', 'Affiliation': ''}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Féliot', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Quesnel', 'Affiliation': ''}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001278']
1706,32769511,"Clinical effectiveness of ultrasound-guided dual transversus abdominis plane block for postoperative analgesia in open abdominal aortic surgery patients: The randomised, double-blind ETAP trial.",,2020,,['open abdominal aortic surgery patients'],['ultrasound-guided dual transversus abdominis plane block'],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",[],,0.615371,,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Chenet', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon (JC, ED, TL, VS, SP-F, ES, GB), EA 3920, Bourgogne Franche-Comte University (LSdM, SP-F, ES, GB), Department of Vascular Surgery (LSdM) and Clinical Methodology Center, University Hospital of Besancon, Besancon, France (MP).'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Dupont', 'Affiliation': ''}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Salomon du Mont', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Salignon', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Puyraveau', 'Affiliation': ''}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Pili-Floury', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Samain', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Besch', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001240']
1707,32769515,Efficacy of incisional infiltration and intraperitoneal instillation of ropivacaine for the management of pain after laparoscopic sleeve gastrectomy: A randomised clinical trial.,,2020,,['pain after laparoscopic sleeve gastrectomy'],['incisional infiltration and intraperitoneal instillation of ropivacaine'],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]",[],,0.0516737,,"[{'ForeName': 'Leonidas', 'Initials': 'L', 'LastName': 'Alevizos', 'Affiliation': 'From the 1st Department of Propaedeutic Surgery, Hippokration General Hospital, Athens Medical School, Athens, Greece (LA, VK, KA, EM, GZ, EL) and Department of Anaesthesiology and Pain Management, American Medical Centre, Nicosia, Cyprus (PZ).'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Zavridis', 'Affiliation': ''}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Kalles', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Albanopoulos', 'Affiliation': ''}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Menenakos', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zografos', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Leandros', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001206']
1708,32769842,Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial.,"SIGNIFICANCE


Lotrafilcon B lenses packaged in and cared for with block copolymer-containing (polyoxyethylene-polyoxybutylene; EOBO) lens care solutions resulted in lower cholesterol extraction than each of the habitual silicone hydrogel lens/multipurpose solution (MPS) regimens tested.
PURPOSE


This study aimed to compare the extracted cholesterol of lotrafilcon B lenses packaged in and cared for with EOBO-containing lens care solutions with the extracted cholesterol of habitual silicone hydrogel lenses cared for with MPS not containing EOBO.
METHODS


In this prospective, randomized, observer-masked parallel study, habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS were randomized 1:1 to lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS. Subjects randomized to lotrafilcon B were further randomized to one of two EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde (Alcon Laboratories, Inc., Fort Worth, TX). A subset of right eye lenses was collected after wear, and total cholesterol was extracted and measured using a fluorometric enzymatic assay.
RESULTS


Of 143 lenses analyzed, 95 were from subjects randomized to their habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE PUREMOIST. The mean amounts of cholesterol extracted from lotrafilcon B + EOBO lenses cared for with CLEAR CARE PLUS with HydraGlyde (0.28 ± 0.18 μg/lens) and OPTI-FREE PUREMOIST (0.28 ± 0.48 μg/lens) were significantly lower than those extracted from senofilcon C (4.18 ± 3.25 μg/lens), senofilcon A (2.19 ± 2.69 μg/lens), comfilcon A (2.17 ± 1.47 μg/lens), and samfilcon A (2.07 ± 1.48 μg/lens) lenses used with MPS (P < .0001 each).
CONCLUSIONS


Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.",2020,"CONCLUSIONS


Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.","['habitual silicone hydrogel lenses cared for with MPS not containing EOBO', 'Of 143 lenses analyzed', 'habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS']","['polyoxyethylene-polyoxybutylene-containing lens care solutions', 'lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS', 'EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde', 'habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE']",[],"[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C2002497', 'cui_str': 'senofilcon A'}, {'cui': 'C2715682', 'cui_str': 'comfilcon A'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2001571', 'cui_str': 'lotrafilcon B'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]",[],,0.0694105,"CONCLUSIONS


Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Shows', 'Affiliation': 'Alcon Research, LLC, Fort Worth, Texas.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Redfern', 'Affiliation': 'College of Optometry, University of Houston, Houston, Texas.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Sickenberger', 'Affiliation': 'Jenvis Research, Ernst-Abbe University of Applied Sciences, Jena, Germany.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Fogt', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schulze', 'Affiliation': 'University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lievens', 'Affiliation': 'Southern College of Optometry, Memphis, Tennessee.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Szczotka-Flynn', 'Affiliation': 'University Hospitals of Cleveland Eye Institute, Cleveland, Ohio.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwarz', 'Affiliation': 'Private Practice, Hildesheim, Germany.'}, {'ForeName': 'Anna A', 'Initials': 'AA', 'LastName': 'Tichenor', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Marx', 'Affiliation': 'Jenvis Research, Ernst-Abbe University of Applied Sciences, Jena, Germany.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'Lemp-Hull', 'Affiliation': 'Alcon Research, LLC, Fort Worth, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001553']
1709,32769914,Effect of butylphthalide on new cerebral microbleeds in patients with acute ischemic stroke.,"BACKGROUND


To evaluate the effect of dl-3-N-butylphthalide (NBP) on new cerebral microbleeds (CMBs) in patients with acute ischemic stroke (AIS).
METHODS


We will prospectively enroll patients with AIS admitted to the stroke center of Jingjiang People's Hospital. Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1. Patients will complete the brain magnetic resonance imaging within 48 hours and 14 days after stroke onset to observe the CMBs through susceptibility weighted imaging, and evaluate whether the use of NBP will affect the new CMBs in AIS patients. SPSS 20.0 will be used for statistical analyses.
RESULT


We will provide practical and targeted results assessing the safety of NBP for AIS patients, to provide reference for clinical use of NBP.
CONCLUSION


The stronger evidence about the effect of NBP on new CMBs in AIS patients will be provided for clinicians.",2020,Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1.,"[""enroll patients with AIS admitted to the stroke center of Jingjiang People's Hospital"", 'patients with acute ischemic stroke (AIS', 'patients with acute ischemic stroke']","['butylphthalide', 'dl-3-N-butylphthalide (NBP', 'NBP group (NBP injection) or the control group (NBP injection placebo', 'NBP']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.122005,Qualified participants will be randomly assigned to either the NBP group (NBP injection) or the control group (NBP injection placebo) in a ratio of 1:1.,"[{'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Zhiqun', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhai', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Yanrong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Clinical Pharmacy, Jingjiang People's Hospital, the Seventh Affiliated Hospital of Yangzhou University, Jiangsu, China.""}]",Medicine,['10.1097/MD.0000000000021594']
1710,32769919,"Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial.","BACKGROUND


Low back pain (LBP) affects approximately 51% to 57% of hospital nurses and nurses' aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP.
METHODS AND ANALYSIS


We conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to 2 groups: intervention group, where patients received LED photobiomodulation therapy 3 times a week for 2 weeks, and the sham group, where patients had sham therapy 3 times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index. The outcome measures were assessed before therapy and 2weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.
DISCUSSION


This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. Our results will be useful for patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain.
TRIAL REGISTRATION NUMBER


NCT04424823.",2020,"Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index.","['non-specific low back pain in working nurses', ""hospital nurses and nurses' aides in Europe"", ""patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain"", '148 patients with NSCLBP']","['Light-emitting diode photobiomodulation therapy', 'LED therapy', 'light-emitting diode (LED) therapy', 'low-level laser therapy', 'LED photobiomodulation therapy', 'Light therapy', 'placebo']","['visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times', 'multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1271036', 'cui_str': 'Hospital nurse'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1444228', 'cui_str': 'Range of motion assessment'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",148.0,0.57227,"Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index.","[{'ForeName': 'Yen-Po', 'Initials': 'YP', 'LastName': 'Lin', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Ying-Hao', 'Initials': 'YH', 'LastName': 'Su', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Shih-Fang', 'Initials': 'SF', 'LastName': 'Chin', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Chou', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taipei, Taiwan (R.O.C.).'}, {'ForeName': 'Wei-Tso', 'Initials': 'WT', 'LastName': 'Chia', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Hsinchu City.'}]",Medicine,['10.1097/MD.0000000000021611']
1711,32768682,Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.,"Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and implementation of this approach. Thus, we will conduct a two-arm randomized trial in 128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing. The primary aim will compare weight loss between interventions arms across 6 months. Secondarily, we will compare weight loss (0-18 mos.), the proportion of participants who achieve clinically meaningful weight loss (≥5%) from 0 to 6 and 0 to18 months, and changes in quality of life from 0 to 6 and 0 to 18 months between interventions arms. We will also conduct cost, cost-effectiveness and contingent valuation comparisons and explore the influence of behavioral session attendance, compliance with the recommendations for diet and physical activity, self-monitoring of diet and physical activity, barriers to physical activity, sleep quality, and medications on weight change across 6 and 18 months. NCT REGISTRATION: NCT04046471.",2020,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","['adults with mobility related disabilities', 'adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an', '128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between', 'Adults with mobility related disabilities (MRDs']","['Weight management', 'enhanced Stop Light Diet (eSLD', 'interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing']","['quality of life', 'weight loss', 'physical activity, sleep quality, and medications on weight change', 'meaningful weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0419181', 'cui_str': 'Light diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",128.0,0.0374796,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@kumc.edu.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Smith', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: psmith18@kumc.edu.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: mmayo@kumc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rlee2@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106098']
1712,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2020,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
1713,32769505,"Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial.","BACKGROUND


Adding a regional block to general anaesthesia can prevent postoperative pain and improve peripheral circulation.
OBJECTIVE


To seek improved postoperative analgesia and care due to a long-acting combined femoral and sciatic nerve block in patients undergoing femoropopliteal bypass surgery.
DESIGN


A randomised, double-blind, controlled trial.
SETTING


Vascular surgery unit of a French university hospital.
PATIENTS


Forty-four adults scheduled for bypass surgery under general anaesthesia.
INTERVENTION


Patients were allocated to receive either an active nerve block with 20 ml of 0.375% levobupivacaine and clonidine 0.5 μg kg, or a simulated (sham) block only, but with local anaesthesia of the skin, before general anaesthesia. General anaesthesia was standardised with propofol, then sevoflurane and sufentanil adjusted according to clinical need. Postoperative analgesia was standardised with paracetamol 1 g every 6 h, and intravenous morphine, initially titrated in the postanaesthesia care unit and then patient-controlled. Oral analgesics were repeated up to day 3.
MAIN OUTCOME MEASURES


The primary outcome was morphine consumption during the first 24 postoperative hours. In a subgroup of postoperative patients distal tissue oxygen saturation was recorded at the lateral side of the blocked calf.
RESULTS


Patients in the active group received less intra-operative sufentanil (median dose 25 vs. 41 μg), needed less morphine during the first 24 h (15 vs. 27 mg) and 72 (20 vs. 35 mg) postoperative hours, than in the control group. They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment. Tolerance outcomes were also similar between groups.
CONCLUSION


Combining the two regional blocks improves the quality of postoperative care in this frail population, probably by reducing the amount of peri-operative opioid.
TRIAL REGISTRATION


ClinicalTrials.gov (ref. NCT01785693).",2020,"They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment.","['patients undergoing femoropopliteal bypass surgery', 'Forty-four adults scheduled for bypass surgery under general anaesthesia', 'femoropopliteal bypass surgery', 'Vascular surgery unit of a French university hospital']","['sevoflurane and sufentanil', 'active nerve block with 20\u200aml of 0.375% levobupivacaine and clonidine 0.5\u200aμg\u200akg, or a simulated (sham) block only, but with local anaesthesia of the skin, before general anaesthesia', 'paracetamol', 'long-acting combined femoral and sciatic nerve block', 'levobupivacaine and clonidine', 'propofol', 'morphine']","['Postoperative analgesia', 'pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes', 'postoperative patients distal tissue oxygen saturation', 'quality of postoperative care', 'morphine consumption', 'intra-operative sufentanil', 'Tolerance outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0190932', 'cui_str': 'Femoral-popliteal artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0600378', 'cui_str': 'Rehabilitation Outcome'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",44.0,0.534089,"They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Charvin', 'Affiliation': 'From the CHU Clermont-Ferrand, Médecine Péri-Opératoire (MC, FL, PJ, A-LC, EF); Université Clermont-Auvergne (EF); CHU Clermont-Ferrand, Unité de Biostatistiques, Direction de la Recherche Clinique et des Innovations (BP); CHU Clermont-Ferrand, Centre de Pharmacologie Clinique (CD); and INSERM, CIC1405 & UMR1107, Clermont-Ferrand, France (CD).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Longeras', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jouve', 'Affiliation': ''}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Cherprenet', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001263']
1714,32772509,Effects of a Web-Based Educational Support Intervention on Total Exercise and Cardiovascular Risk Markers in Adults With Coronary Heart Disease.,"BACKGROUND


eHealth educational programs have proven to be an effective means for health promotion, yet limited studies have been conducted for coronary heart disease (CHD) patients to improve their total physical exercise, self-efficacy for exercise, and cardiovascular risk factor profile.
METHOD


A prospective randomized controlled trial (RCT) was conducted in two cardiac clinics in Hong Kong. Four hundred thirty-eight eligible CHD clients were randomly assigned to either the control or the intervention group. All of the participants received standard care, which consisted of regular medical and nursing care in the cardiac clinic. The intervention group received an additional web-based educational support intervention (eHES), which consisted of a 20-minute individual educational session on the use of the eHES web link. The eHES web link contains a health information platform related to CHD care and an individual member area with records of health measures and physical exercise data for six months. Data were collected at baseline, at three-month and six-month intervals at the cardiac clinic. The primary outcome was the total amount of physical exercise, measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire. The secondary outcomes were self-efficacy for exercise and cardiovascular disease (CVD) risk markers (body weight, blood pressure, lipid profile). The data were analyzed using a generalized estimating equations model.
RESULTS


The intervention group reported a statistically higher amount of physical exercise and a higher HDL-C at 3 and 6 months, respectively. There were no statistical differences between the groups in self-efficacy for exercise and other CVD risk markers.
LINKING EVIDENCE TO ACTION


The study demonstrated the effectiveness of the eHES in meeting the challenge of boosting the amount of physical exercise and increase HDL-C among CHD patients who engaged for over three months. The results provide insight for eHealth development to support and promote exercise among CHD patients in the community.",2020,"The intervention group reported a statistically higher amount of physical exercise and a higher HDL-C at 3 and 6 months, respectively.","['CHD patients who engaged for over three months', 'Four hundred thirty-eight eligible CHD clients', 'two cardiac clinics in Hong Kong', 'Adults With Coronary Heart Disease']","['Web-Based Educational Support Intervention', 'additional web-based educational support intervention (eHES']","['amount of physical exercise and a higher HDL-C', 'total amount of physical exercise, measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire', 'Total Exercise and Cardiovascular Risk Markers', 'self-efficacy for exercise and cardiovascular disease (CVD) risk markers (body weight, blood pressure, lipid profile']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",438.0,0.0338477,"The intervention group reported a statistically higher amount of physical exercise and a higher HDL-C at 3 and 6 months, respectively.","[{'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Doris Y P', 'Initials': 'DYP', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Sek-Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Janet W H', 'Initials': 'JWH', 'LastName': 'Sit', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12456']
1715,32771678,Gamma transcranial alternating current stimulation improves mood and cognition in patients with major depression.,"Major depression is one of the most common psychiatric disorders with a high rate of treatment resistance where new treatment options are urgently warranted. One of these new options are non-invasive brain stimulation techniques like transcranial magnetic or electric stimulation. One of the latter is transcranial Alternating Current Stimulation (tACS) in various frequencies. Here, we report a case series of six patients suffering from major depression treated with tACS in gamma (40 Hz) frequency. Patients were randomized to two groups, receiving either two 10-min stimulations (group 1) or a 20-min stimulation or per day (group 2) over ten days. Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2). Results also showed an improvement in cognitive functions assessed by word fluency and n-back test. It is hypothesized that gamma tACS could help to synchronize disturbed frequency bands in frontal and prefrontal cortex areas and thus restore dysbalanced neural connectivity in psychiatric disorders.",2020,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","['six patients suffering from major depression treated with tACS in gamma (40\xa0Hz) frequency', 'patients with major depression']","['Gamma transcranial alternating current stimulation', 'transcranial Alternating Current Stimulation (tACS', 'gamma tACS']","['Hamilton Depression Rating Scale and Beck Depression Inventory', 'cognitive functions assessed by word fluency and n-back test', 'mood and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0221377,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","[{'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Senner', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Institute of Psychiatric Phenomics and Genomics (IPPG), Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of Sao Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Bernau, Felden, Germany. Electronic address: u.palm@medicalpark.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.009']
1716,32790844,"Efficacy of folinic acid rescue following MTX GVHD prophylaxis: results of a double-blind, randomized, controlled study.","The use of methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis is associated with increased rates of organ-specific toxicities. Despite limited data, the European Society for Blood and Marrow Transplantation-European LeukemiaNet working group recommend the use of folinic acid (FA) rescue to reduce MTX toxicity after allogeneic hematopoietic cell transplantation (allo-HCT). In a multicenter, double-blind, randomized, controlled trial, we explored whether FA rescue reduces MTX-induced toxicity. We enrolled patients undergoing allo-HCT with myeloablative conditioning with peripheral blood stem cell grafts, with GVHD prophylaxis consisting of cyclosporine and MTX. Patients were randomized to receive FA or placebo starting 24 hours after each MTX dose and continuing over 24 hours in 3 to 4 divided doses. The primary end point was the rate of grades 3 and 4 oral mucositis. After enrollment of 52 patients (FA, n = 28; placebo, n = 24), preplanned interim analysis revealed similar rates of grade 3 and 4 (46.6% vs 45.8%; P = .97) and grades 1 to 4 (83.3% vs 77.8%; P = .65) oral mucositis. With a median follow-up of 17 (range, 4.5-50) months, there was no difference in the rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival. These interim results did not support continuation of the study. We conclude that FA rescue after MTX GVHD prophylaxis does not decrease regimen-related toxicity or affect transplantation outcomes. This study was registered at clinicaltrials.gov as #NCT02506231.",2020,"With a median follow-up of 17 (range, 4.5-50) months, there was no difference in the rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival.","['enrolled patients undergoing allo-HCT with myeloablative conditioning with peripheral blood stem cell grafts, with GVHD prophylaxis consisting of']","['FA or placebo', 'methotrexate (MTX', 'folinic acid (FA', 'placebo', 'cyclosporine and MTX', 'FA', 'MTX GVHD prophylaxis', 'folinic acid']","['MTX toxicity', 'MTX-induced toxicity', 'rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival', 'rate of grades 3 and 4 oral mucositis', 'oral mucositis', 'rates of organ-specific toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0568062', 'cui_str': 'Methotrexate poisoning'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.615281,"With a median follow-up of 17 (range, 4.5-50) months, there was no difference in the rates of acute and chronic GVHD, disease relapse, nonrelapse mortality, and overall survival.","[{'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Yeshurun', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Rozovski', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Pasvolsky', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Wolach', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Ram', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Odelia', 'Initials': 'O', 'LastName': 'Amit', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Tsila', 'Initials': 'T', 'LastName': 'Zuckerman', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Pek', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Maly', 'Initials': 'M', 'LastName': 'Rubinstein', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sela-Navon', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Raanani', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Shargian-Alon', 'Affiliation': 'Institution of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}]",Blood advances,['10.1182/bloodadvances.2020002039']
1717,32790845,Recombinant human thrombopoietin promotes platelet engraftment after umbilical cord blood transplantation.,"Delayed platelet engraftment is a common complication after umbilical cord blood transplantation (UCBT) accompanied by increased transplant-related complications or death. This study was designed to determine the safety and efficacy of recombinant human thrombopoietin (rhTPO) in promoting platelet engraftment after UCBT. A total of 120 patients scheduled to receive UCBT were randomly assigned to the rhTPO group (300 U/kg once daily from days 14 to 28 after UCBT, n = 60) or the control group (n = 60). The primary outcome was the 60-day cumulative incidence of platelet engraftment after single-unit cord blood transplantation. The 60-day cumulative incidence of platelet engraftment (platelet count ≥20 × 109/L) and the 120-day cumulative incidence of platelet recovery (platelet count ≥50 × 109/L) were both significantly higher in the rhTPO group than in the control group (83.1% vs 66.7%, P = .020; and 81.4% vs 65.0%, P = .032, respectively). In addition, the number of required platelet infusions was significantly lower in the rhTPO group than in the control group (6 vs 8 units, respectively; P = .026). The cumulative incidence of neutrophil engraftment and the probability of 2-year overall survival, disease-free survival, and graft-versus-host disease-free relapse-free survival did not differ between the 2 groups. Other transplant-related outcomes and complications did not differ between the 2 groups, and no severe adverse effects were observed in patients receiving rhTPO. This study demonstrated that rhTPO is well tolerated in patients and could effectively promote platelet engraftment after UCBT. This study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) as ChiCTR-IPR-16009357.",2020,"Other transplant-related outcomes and complications did not differ between the 2 groups, and no severe adverse effects were observed in patients receiving rhTPO.","['umbilical cord blood transplantation', '120 patients scheduled to receive']","['recombinant human thrombopoietin (rhTPO', 'UCBT', 'Recombinant human thrombopoietin', 'rhTPO']","['120-day cumulative incidence of platelet recovery (platelet count ≥50 × 109/L', 'Delayed platelet engraftment', 'cumulative incidence of neutrophil engraftment and the probability of 2-year overall survival, disease-free survival, and graft-versus-host disease-free relapse-free survival', 'number of required platelet infusions', '60-day cumulative incidence of platelet engraftment', 'severe adverse effects', '60-day cumulative incidence of platelet engraftment after single-unit cord blood transplantation']","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",120.0,0.0992311,"Other transplant-related outcomes and complications did not differ between the 2 groups, and no severe adverse effects were observed in patients receiving rhTPO.","[{'ForeName': 'Baolin', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Kaidi', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Xuhan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Ning', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Jiehui', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Zimin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}]",Blood advances,['10.1182/bloodadvances.2020002257']
1718,32472590,Therapeutic benefits of combined sorafenib for intermediate hepatocellular carcinoma unresponsive to transarterial chemoembolization in a Chinese population.,"OBJECTIVE


Transarterial chemoembolization (TACE) is the treatment modality for intermediate, or Barcelona Clinic Liver Cancer stage B, hepatocellular carcinoma (HCC), but its beneficial effect on outcomes is still unsatisfactory. This study aimed to assess the outcomes of combined TACE and sorafenib for patients with intermediate HCC.
METHODS


Patients with intermediate HCC who were receiving TACE alone (the monotherapy group), or combined TACE and sorafenib (the combined therapy group) from January 2013 to June 2018 were enrolled.
RESULTS


Altogether 64 patients were enrolled, of whom 34 were assigned to the monotherapy group and 30 to the combined therapy group. A prolonged time-to-progression (TTP) (mean 14.46 mo vs 6.39 mo, P = 0.001) was noted in the combined therapy group compared with the monotherapy group. Overall survival (OS) (mean 18.96 mo vs15.44 mo, P = 1.000) between the two groups did not differ significantly. After adjustment, there were no significant differences in the 12-18 month mortality rate between the two groups.
CONCLUSION


Patients with intermediate HCC receiving combined TACE and sorafenib had a better TTP, but not OS, than those receiving TACE alone.",2020,"Overall survival (OS) (mean 18.96 mo vs15.44 mo, P = 1.000) between the two groups did not differ significantly.","['Altogether 64 patients were enrolled, of whom 34 were assigned to the monotherapy group and 30 to the combined therapy group', 'the combined therapy group) from January 2013 to June 2018 were enrolled', 'Patients with intermediate HCC who were receiving TACE alone (the monotherapy group), or', 'patients with intermediate HCC', 'intermediate hepatocellular carcinoma unresponsive to transarterial chemoembolization in a Chinese population']","['TACE', 'combined TACE and sorafenib', 'Transarterial chemoembolization (TACE', 'TACE and sorafenib', 'combined sorafenib']","['prolonged time-to-progression (TTP', 'Overall survival (OS', 'mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",64.0,0.026161,"Overall survival (OS) (mean 18.96 mo vs15.44 mo, P = 1.000) between the two groups did not differ significantly.","[{'ForeName': 'Shou Wu', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan Province, China.'}, {'ForeName': 'Chun Fang', 'Initials': 'CF', 'LastName': 'Tung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan Province, China.'}, {'ForeName': 'Yen Chun', 'Initials': 'YC', 'LastName': 'Peng', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan Province, China.'}, {'ForeName': 'Han Chung', 'Initials': 'HC', 'LastName': 'Lien', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan Province, China.'}, {'ForeName': 'Chi Sen', 'Initials': 'CS', 'LastName': 'Chang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan Province, China.'}]",Journal of digestive diseases,['10.1111/1751-2980.12911']
1719,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND


Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS


We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS


A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
1720,32769633,Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix.,"OBJECTIVE


To evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30).
METHODS


Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis were pooled and analyzed as three groups: placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. Patients were administered the EHP-30 questionnaire at baseline, and at months 1, 3, and 6 of treatment. Previously established responder definitions were applied to determine percentages of patients with clinically meaningful EHP-30 improvements. The probability of meeting EHP-30 responder definitions with elagolix compared with placebo at months 3 and 6 was determined by Poisson regression analysis, controlling for baseline scores.
RESULTS


At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group. Although lower in magnitude than the 200-mg group, the 150-mg group also had greater probabilities of meeting responder definitions than the placebo group for all subscales except sexual intercourse. The probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being were 75% (aRR 1.75, 95% CI 1.44-2.14), 50% (aRR 1.50, 95% CI 1.25-1.80), 22% (aRR 1.22, 95% CI 1.01-1.47), 30% (aRR 1.30, 95% CI 1.09-1.53), and 35% (aRR 1.35, 95% CI 1.16-1.57) greater, respectively (all P<.05), in the 150-mg group than in the placebo group.
CONCLUSION


Patients with moderate to severe pain associated with endometriosis and were treated with elagolix experienced clinically meaningful HRQOL improvements.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01620528 and NCT01931670.
FUNDING SOURCE


AbbVie Inc.",2020,"At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group.","['Patients', 'Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis']","['elagolix', 'Elagolix', 'placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily', 'placebo']","['health-related quality of life (HRQOL', 'Health-Related Quality of Life Improvements', 'probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being', 'probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse', 'probabilities of meeting responder definitions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704593', 'cui_str': 'elagolix 150 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150063', 'cui_str': 'Feeling powerless'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",,0.419231,"At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group.","[{'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut; AbbVie Inc., North Chicago, Illinois; and Evidera, Bethesda, Maryland.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': ''}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Johns', 'Affiliation': ''}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Snabes', 'Affiliation': ''}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003917']
1721,32769639,Reducing the Risk for Postpartum Depression in Adolescent Mothers: A Randomized Controlled Trial.,"OBJECTIVE


To estimate the effect of an interpersonal therapy-based intervention on reducing the risk of postpartum depression in adolescents.
METHODS


A randomized controlled trial enrolled 250 pregnant adolescents who were aged 18 years or younger at conception. The initial sample size calculation estimated 276 participants (324 with attrition) were needed to detect a 50% reduction in risk of the primary outcome, postpartum major depressive episode, with an alpha of 0.05% and 80% power. An interim analysis by the Data Safety and Monitoring Committee informed a revision in the sample size target to 250. Participants were randomized to the intervention (n=129) or a time-matched control group (n=121) who attended sessions about pregnancy topics. Each group received five prenatal sessions and a postpartum booster session. A structured diagnostic interview was administered at baseline and specific time points through 12-months postpartum to assess for major depressive episode onset.
RESULTS


Participants were recruited from December 2011 to May 2016 through urban prenatal care sites in the state of Rhode Island. Of the 250 participants, 58% identified as Hispanic and 20% as black or African American. The rate of major depressive episode by 12 months postpartum was 7.0% (95% CI 2.3-11.7%) in the control group and 7.6% (95% CI 2.5-12.7%) in the intervention group, with no significant difference between groups at any time point (P=.88 by log-rank test).
CONCLUSION


No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted). Enhanced local community resources available to pregnant and parenting adolescents during the study period may be an explanation for this result.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01482832.",2020,"No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted).","['250 pregnant adolescents who were aged 18 years or younger at conception', 'Participants were recruited from December 2011 to May 2016 through urban prenatal care sites in the state of Rhode Island', '276 participants (324 with attrition', 'pregnant and parenting adolescents', 'Adolescent Mothers', 'adolescents', '250 participants, 58% identified as Hispanic and 20% as black or African American']","['time-matched control group (n=121) who attended sessions about pregnancy topics', 'interpersonal therapy-based intervention', 'five prenatal sessions and a postpartum booster session']","['rate of major depressive episode', 'rates of major depressive episode']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]",250.0,0.208404,"No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted).","[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Phipps', 'Affiliation': 'Departments of Obstetrics and Gynecology and Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, the Department of Epidemiology, Brown University School of Public Health, the Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island, and the Women & Infants Hospital of Rhode Island, Providence, Rhode Island; the University of Cape Town, Cape Town, South Africa, and the Pacific Institute for Research and Evaluation, Beltsville, Maryland.'}, {'ForeName': 'Crystal F', 'Initials': 'CF', 'LastName': 'Ware', 'Affiliation': ''}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Stout', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': ''}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004003']
1722,32769754,Remote corneal suturing wet lab: Microsurgical education during the COVID-19 pandemic.,"PURPOSE


To study the feasibility and efficacy of a novel remote wet lab for microsurgical education using a corneal suturing task.
SETTING


Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.
DESIGN


Prospective randomized controlled study.
METHODS


Ten ophthalmology residents were stratified by postgraduate year and randomized to perform a corneal suturing task consisting of placing the 4 cardinal sutures for a penetrating keratoplasty in porcine eyes with or without remote ophthalmology attending feedback. Subsequently, both groups repeated the same task without remote feedback to test whether initial remote feedback affected subsequent performance. Finally, the group without feedback was crossed over to repeat the same corneal suturing task with remote feedback. The effectiveness of the remote wet lab was assessed subjectively by survey and objectively by grading each suture pass.
RESULTS


Resident-reported comfort with corneal suturing improved significantly after the remote wet lab for all residents. Residents and attendings rated the remote wet lab as equally or more effective compared to prior in-person wet labs and overall effective in corneal suturing. Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale. Objective corneal suturing performance was similar for both groups.
CONCLUSION


The remote wet lab was feasible and effective for training ophthalmology residents in corneal suturing. This represents a novel social distancing compliant platform for microsurgical education during the COVID-19 pandemic.",2020,Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale.,"['Ten ophthalmology residents', 'Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA']","['Remote corneal suturing wet lab', 'corneal suturing task consisting of placing the 4 cardinal sutures for a penetrating keratoplasty in porcine eyes with or without remote ophthalmology attending feedback', 'novel remote wet lab for microsurgical education']","['comfort with corneal suturing', 'Objective corneal suturing performance']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0022592', 'cui_str': 'Penetrating keratoplasty'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0200271,Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale.,"[{'ForeName': 'Neel D', 'Initials': 'ND', 'LastName': 'Pasricha', 'Affiliation': 'From the Department of Ophthalmology (Pasricha, Haq, Chan, Redd, Seitzman, Parikh, Kim, Schallhorn, Ramanathan), School of Medicine (Ahmad), and Francis I. Proctor Foundation (Redd, Seitzman, Schallhorn), University of California San Francisco, San Francisco, California, USA. Supported in part by a Research to Prevent Blindness unrestricted grant to the University of California San Francisco, Department of Ophthalmology.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Haq', 'Affiliation': ''}, {'ForeName': 'Tessnim R', 'Initials': 'TR', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Travis K', 'Initials': 'TK', 'LastName': 'Redd', 'Affiliation': ''}, {'ForeName': 'Gerami D', 'Initials': 'GD', 'LastName': 'Seitzman', 'Affiliation': ''}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Parikh', 'Affiliation': ''}, {'ForeName': 'Tyson N', 'Initials': 'TN', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Schallhorn', 'Affiliation': ''}, {'ForeName': 'Saras', 'Initials': 'S', 'LastName': 'Ramanathan', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000374']
1723,32769884,The therapeutic effect of repetitive transcranial magnetic stimulation in elderly depression patients.,"BACKGROUND


Depression, a common psychiatric disorder in elderly, serves as a remarkable precipitating factor for suicide among the elderly people. Here, a randomized double-blinded study was performed to investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) on improving the clinical symptoms and reducing suicidal ideation in elderly patients with depression.
METHODS


In this study, 103 elderly patients with depression and suicidal ideation were randomly divided into 2 groups, 48 cases in the rTMS group and 55 cases in the control group (sham rTMS). Both groups received routine drug therapy with rTMS or sham rTMS. The patients received evaluation by Hamilton depression scale and self-rating idea of suicide scale before treatment and after 2 and 4 weeks of treatment, respectively.
RESULTS


The measurement from the present study demonstrated that Hamilton depression scale and self-rating idea of suicide scale scores decreased to varying degrees in the 2 groups after treatment, and the decrease was more significant in rTMS group. The rate of marked effectiveness was much higher in rTMS group after 2 weeks of treatment compared with the control group. Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
CONCLUSION


Together, the present study shows that rTMS with routine drug therapy exhibited effect with quick onset to improve the clinical symptoms and reduce suicidal ideation in elderly patients with depression.",2020,"Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
","['elderly depression patients', 'elderly patients with depression', '103 elderly patients with depression and suicidal ideation']","['repetitive transcranial magnetic stimulation', 'rTMS', 'control group (sham rTMS', 'routine drug therapy with rTMS or sham rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['Hamilton depression scale and self-rating idea of suicide scale', 'rate of marked effectiveness', 'suicidal ideation', 'Hamilton depression scale and self-rating idea of suicide scale scores', 'rate of moderate effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",103.0,0.0269797,"Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.
","[{'ForeName': 'Lilei', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Psychology, Jingmen Oral Hospital, Jingmen, Hubei, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Xinfu', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Clinical Psychology, Jingmen NO.2 People's Hospital, Jingmen, Hubei.""}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Luan', 'Affiliation': ""Department of Psychiatry, The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi.""}]",Medicine,['10.1097/MD.0000000000021493']
1724,32769888,Computer-navigated versus conventional total knee arthroplasty: A randomized controlled trial protocol in China.,"BACKGROUND


The literature lacks studies that confirm whether the improved radiographic alignment that can be achieved with computer-navigated total knee arthroplasty (TKA) improves patients' activities of daily living or the durability of total knee prostheses. Thus, in this protocol, we designed a randomized controlled trial to compare implant alignment, functional scores, and survival of the implant using computer-assisted surgery versus a conventional surgical technique.
METHODS


This prospective, blinded randomized controlled trial was conducted at our single hospital. This study was approved by the ethics committee of Jiaxing Second Hospital. The patient inclusion criteria were age 20 to 80 years' old, a body mass index of ≤35 kg/m, and consented for primary knee arthroplasty performed through a medial parapatellar approach by the senior author. We randomized consented study participants on a 1:1 ratio to 1 of 2 study groups using a computer-generated list of random numbers in varying block sizes. The primary outcome in this study was the Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant. Statistical significance was defined as a P value of ≤0.05.
CONCLUSIONS


Authors hypothesized that computer-assisted surgery in primary TKA improves implant alignment, functional scores, and survival of the implant compared to the conventional technique.",2020,"Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant.","[""patient inclusion criteria were age 20 to 80 years' old, a body mass index of ≤35\u200akg/m, and consented for primary knee arthroplasty performed through a medial parapatellar approach by the senior author""]","['computer-navigated total knee arthroplasty (TKA', 'implant using computer-assisted surgery versus a conventional surgical technique', 'Computer-navigated versus conventional total knee arthroplasty']","['implant alignment, functional scores, and survival of the implant', 'Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant', 'Knee Injury and Osteoarthritis Outcome Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0949696', 'cui_str': 'Computer-Assisted Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}]",,0.166324,"Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant.","[{'ForeName': 'Yefeng', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of orthopedics, Jiaxing Second Hospital, Zhejiang Province, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021508']
1725,32768874,Intermittent Motivational Interviewing and Transdiagnostic CBT for Anxiety: A Randomized Controlled Trial.,"Recent meta-analytic findings suggest that Motivational Interviewing (MI) used as an adjunct to Cognitive Behavior Therapy (CBT) for anxiety disorders improves overall treatment outcomes (Marker & Norton, 2018). However, when used as a prelude to CBT, MI significantly increases the length of treatment and numerous studies note that the effectiveness of pre-treatment MI subsides over time. The current study adapted an already established 12-session transdiagnostic CBT protocol (tCBT, Norton, 2012) to include one hour of MI spread across four sessions of tCBT (sessions 1, 3, 8, and 10) at 15 minutes each, with the option of including additional MI if resistance arose in therapy. Thirty-six treatment seeking adults with principal anxiety disorder diagnosis were randomly assigned to receive intermittent MI and tCBT (iMI + tCBT) or tCBT and psychoeducation. Results indicated that the iMI + tCBT condition significantly outperformed the tCBT condition on several primary outcome variables. While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning. These effects were not moderated by baseline motivation or baseline ambivalence. The study also found that the iMI + tCBT condition showed significantly greater improvement to comorbid conditions and greater reduction in self-report depressive symptoms. The inclusion of MI did not impact participant drop out. This study provides further support for integrating MI and tCBT and highlights that even small doses of MI can improve treatment outcomes, without increasing length of usual therapy. Limitations and future research options are also discussed.",2020,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","['for Anxiety', 'Thirty-six treatment seeking adults with principal anxiety disorder diagnosis']","['Intermittent Motivational Interviewing and Transdiagnostic CBT', 'Cognitive Behavior Therapy (CBT', 'Motivational Interviewing (MI', 'intermittent MI and tCBT (iMI\u202f+\u202ftCBT) or tCBT and psychoeducation']","['self-report depressive symptoms', ""composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning""]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",36.0,0.0207886,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Marker', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Bronte E', 'Initials': 'BE', 'LastName': 'Corbett', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'Monash University, Australia. Electronic address: Peter.Norton@monash.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102276']
1726,32768938,Yidu-toxicity blocking lung decoction ameliorates inflammation in severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome by eliminating IL-6 and TNF-a.,"The present study investigates the differences in inflammatory agents alterations, immune function, and leukocyte differential count evaluation in severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome after the recommended Chinese medicine prescription of Yidu-toxicity blocking lung decoction. A total of 40 patients with yidu-toxicity blocking lung syndrome, diagnosed as severe pneumonia of SARS-COV-2 following the latest Chinese national recommendations for the diagnosis and treatment of pneumonia caused by SARS-COV-2 (the 5th edition), were recruited. They were randomly divided into the pure western medicine therapy group (PWM) and integrated into Chinese and Western medicine therapy group (ICW). The general strategies were given to both groups according to the national recommendations, and the ICW group was given Yidu-toxicity blocking lung decoction extraorally. A radioimmunoassay method was adopted to detect the content of IL-6, IL-8,IL-2R,TNF-α, procalcitonin (PCT) and high-sensitivity C-reactive protein (hs-CRP) in sera. Flow cytometry was used to determine the peripheral blood lymphocyte subsets (the levels of CD3+, CD4+, CD8+, and the ratios of CD4+/CD8+). The white blood cell counts (WBC#), neutrophils count(N#), and lymphocyte counts (L#) were measured using a fully automatic blood rheological instrument. The t-test or Rank Sum Test and Spearman analysis were conducted to evaluate the differences. The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment. Infection related indicators such as WBC#, N#, L#, hs-CRP showed no differences. The analysis showed that there was no statistical difference in the values of CD4 and CD8 between the two groups. By the end of Day 29, all patients were discharged and the final cure rate for both group were 100 %. Taken together, we conclude that Yidu-toxicity blocking lung decoction could relieve inflammation of SARS-COV-2 patients with yidu-toxicity blocking lung syndrome by eliminating inflammatory agents. CM can serve as a complementary medication to western medicine, which should be highlighted in clinical settings.",2020,The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment.,"['severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome', '40 patients with yidu-toxicity blocking lung syndrome, diagnosed as severe pneumonia of SARS-COV-2 following the latest Chinese national recommendations for the diagnosis and treatment of pneumonia caused by SARS-COV-2 (the 5th edition), were recruited', 'severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome after the recommended Chinese medicine prescription of Yidu-toxicity blocking lung decoction']","['ICW', 'pure western medicine therapy group (PWM) and integrated into Chinese and Western medicine therapy group (ICW', 'ICW group was given Yidu-toxicity blocking lung decoction extraorally', 'Yidu-toxicity blocking lung decoction']","['TNF-α', 'final cure rate', 'content of IL-6, IL-8,IL-2R,TNF-α, procalcitonin (PCT) and high-sensitivity C-reactive protein (hs-CRP', 'values of CD4 and CD8', 'white blood cell counts (WBC#), neutrophils count(N#), and lymphocyte counts (L', 'IL-6', 'peripheral blood lymphocyte subsets (the levels of CD3+, CD4+, CD8+, and the ratios of CD4+/CD8']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0200254,The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China. Electronic address: zhaojie0506888@126.com.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Chenghua', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Cao', 'Affiliation': 'Department of Orthopaedic, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Taohua', 'Initials': 'T', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230022, China.'}, {'ForeName': 'Qiaoxue', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Wanqun', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Institute for Medical Virology, Goethe University Frankfurt am Main, Frankfurt 60596, Germany.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110436']
1727,32772451,An exploratory randomised controlled trial evaluating text prompts in Lebanon to encourage health-seeking behaviour for hypertension.,"AIMS OF THE STUDY


The current study evaluates the effectiveness of an opportunistic mobile screening on the percentage of people who are aware of whether they may be hypertensive (in an observational study) and the effectiveness of reminder prompts on the percentage of people who seek further medical attention (in a randomised controlled trial).
METHODS USED TO CONDUCT THE STUDY


The screening of 1227 participants (529 female) was conducted during the registration period of the 2018 Beirut International Marathon in Lebanon. Next, 266 participants whose screening indicated hypertension (64 Female) were randomly allocated to a treatment group or a control group in a 1:1 fashion. The treatment group received a reminder prompt to seek further medical attention for their potential hypertension and the control group did not. The overt nature of the text message meant that participants in the treatment group could not be blinded to their group allocation. The primary outcome is participants' self-reports of whether they sought further medical attention.
RESULTS OF THE STUDY


For the opportunistic screening, a 25% prevalence rate and a 24% awareness rate of hypertension was indicated. A McNemar analysis suggested that the screening increased participant awareness (X 2  (N = 1227) = 72.16, P < .001). For the randomised controlled trial, 219 participants provided follow-up data via a phone call (82% retention). A Chi-squared analysis suggested that the reminder prompt successfully encouraged more participants to seek further medical attention, 45.5% treatment group vs 28.0% control group (X 2  (1, N = 219) = 7.19, P = .007, φ = 0.18).
CONCLUSIONS DRAWN AND CLINICAL IMPLICATIONS


Extra support in the form of a brief reminder message can increase the percentage of people who seek further medical attention after attending an opportunistic screening at a marathon event. The discussion reviews how the results align with previous research, strengths and limitations of the current study, and implications for future research and practice.",2020,"A McNemar analysis suggested that the screening increased participant awareness (X 2  (N =1227)=72.16, p<0.001).","['266 participants whose screening indicated hypertension (64 Female', '219 participants provided follow-up data via a phone call (82% retention', '1227 participants (529 female) was conducted during the registration period of the 2018 Beirut International Marathon in Lebanon']","['reminder prompt to seek further medical attention', 'Lebanon', 'opportunistic mobile screening']","['participant awareness', ""participants' self-reports of whether they sought further medical attention""]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C4517806', 'cui_str': '529'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",219.0,0.0881207,"A McNemar analysis suggested that the screening increased participant awareness (X 2  (N =1227)=72.16, p<0.001).","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Schmidtke', 'Affiliation': 'Medical School, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Behavioural Science Group, Warwick Business School, University of Warwick, Coventry, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kabbani', 'Affiliation': 'Cardiology Department, Rafik Hariri University Hospital, Beirut, Lebanon.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Klauznicer', 'Affiliation': 'Supreme Committee for Delivery and Legacy, B4Development Foundation (formerly Qatar Behavioural Insights Unit), Doha, Qatar.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baasiri', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Osseiran', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'El Rifai', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fares', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Saleh', 'Affiliation': 'Nudge Lebanon, Beirut, Lebanon.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Makki', 'Affiliation': 'Supreme Committee for Delivery and Legacy, B4Development Foundation (formerly Qatar Behavioural Insights Unit), Doha, Qatar.'}]",International journal of clinical practice,['10.1111/ijcp.13669']
1728,32771032,"Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8 hourly thrice a day for 5 days), versus oseltamivir (75 mg orally twice a day for 5 days), and versus Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus (COVID-19) nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
TRIAL DESIGN


An adaptive design, set within a comprehensive cohort study, to permit flexibility in this fast-changing clinical and public health scenario. The randomized study will be a multicenter, multiarm, multistage, randomized controlled trial with a parallel design. An observation only cohort will emerge from those not consenting to randomization.
PARTICIPANTS


Eligible will be newly diagnosed patients, either hospitalized or in self-isolation, without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension. Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan. Those pregnant or lactating, severely dyspneic or with respiratory distress, already undergoing treatment, and with serious comorbidities like liver or kidney failure will be excluded.
INTERVENTION AND COMPARATOR


There will be a total of seven comparator groups: Each drug (Hydroxychloroquine Phosphate/Sulfate, Oseltamivir and Azithromycin) given as monotherapy (three groups); combinations of each of two drugs (three groups); and a final group on triple drug regimen.
MAIN OUTCOMES


The laboratory-based primary outcome will be turning the test negative for COVID-19 on qRT-PCR on day 7 of follow-up. The clinical primary outcome will be improvement from baseline of two points on a seven-category ordinal scale of clinical status on day 7 of follow-up.
RANDOMIZATION


Participants will be randomized, maintaining concealment of allocation sequence, using a computer-generated random number list of variable block size into multiple intervention groups in the allocation ratio of 1:1 for all groups.
BLINDING (MASKING)


This is an open label study, neither physician nor participants will be blinded.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


This is an adaptive design and parameters for formal sample size calculation in a new disease of a previously unknown virus are not available. Thus, the final sample size will be subjected to periodic reviews at each stage of adaptive design and subsequent advice of National Data Safety & Management Board (NDSMB) notified by Drug Regulatory Authority of Pakistan.
TRIAL STATUS


Protocol Version 1.7 dated July 5, 2020. By July 03, 2020, the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan. Recruitment started on April 20, 2020. The recruitment is expected to continue for at least three months subject to review by the National Data Safety and Management Board (NDSMB) notified by Drug Regulatory Authority of Pakistan.
TRIAL REGISTRATION


Prospectively registered on 8 April 2020 at clinicaltrials.gov ID: NCT04338698 The full protocol is attached as an additional file, accessible from the Trials website (Additional file1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file2).",2020,Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan.,"['Those pregnant or lactating, severely dyspneic or with respiratory distress, already undergoing treatment, and with serious comorbidities like liver or kidney failure will be excluded', 'newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus', '8 April 2020 at clinicaltrials.gov ID', 'By July 03, 2020, the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan', 'Eligible will be newly diagnosed patients, either hospitalized or in self-isolation, without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension', 'Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan', 'Protocol Version 1.7 dated July 5, 2020']","['Hydroxychloroquine Phosphate/Sulfate', 'oseltamivir', 'Azithromycin', 'Hydroxychloroquine, Oseltamivir and Azithromycin', 'drug (Hydroxychloroquine Phosphate/Sulfate, Oseltamivir and Azithromycin']",['seven-category ordinal scale of clinical status on day 7 of follow-up'],"[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0005489', 'cui_str': 'Bioethics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.220653,Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan.,"[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Akram', 'Affiliation': 'Vice Chancellor/Professor of Internal Medicine, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Shehnoor', 'Initials': 'S', 'LastName': 'Azhar', 'Affiliation': 'Assistant Professor Public Health, University of Health Sciences, Lahore, Pakistan. shehnoor.azhar@gmail.com.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shahzad', 'Affiliation': 'Professor of Pharmacology, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Latif', 'Affiliation': 'Data Analyst at University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Distinguished Investigator at Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}]",Trials,['10.1186/s13063-020-04616-4']
1729,32779452,[Antiangiogenic therapy in high-risk keratoplasty].,"PURPOSE


To analyze the effectiveness and safety of VEGF inhibitor used to improve keratoconus transplant survival in patients with corneal neovascularization as stand-alone and in combination with laser coagulation of ingrowing vessels before keratoplasty.
MATERIAL AND METHODS


The study included 56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV). The patients were divided into three groups. The 1st group included 27 patients with diffuse CNV who were undergoing an antiangiogenic therapy using anti-VEGF drug, the 2nd group - 14 patients with stem cell CNV who underwent laser coagulation of major corneal vessels combined with subconjunctival administration of drug before keratoplasty; the control group consisted of 15 patients with mixed type CNV who were undergoing conventional treatment without antiangiogenic therapy.
RESULTS


During the follow-up (24.5±4.84 months, 4 to 25 months), transplant rejection reaction was recorded in 7 (23%) patients of the 1 st  group, 5 (35%) patients of the 2 nd  group and 9 (60%) patients of the control group.
CONCLUSION


Subconjunctival administration of Aflibercept as a stand-alone measure and in combination with laser coagulation of ingrowing vessels may increase the chances of transparent transplant acceptance in high-risk keratoplasty.",2020,The study included 56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV).,"['56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV', 'patients with corneal neovascularization as stand-alone and in combination with laser coagulation of ingrowing vessels before keratoplasty', 'high-risk keratoplasty', '27 patients with diffuse CNV who were undergoing an antiangiogenic therapy using anti-VEGF drug, the 2nd group - 14 patients with stem cell CNV who underwent']","['VEGF inhibitor', 'Antiangiogenic therapy', 'laser coagulation of major corneal vessels combined with subconjunctival administration of drug before keratoplasty; the control group consisted of 15 patients with mixed type CNV who were undergoing conventional treatment without antiangiogenic therapy', 'Aflibercept']","['transplant rejection reaction', 'keratoconus transplant survival', 'chances of transparent transplant acceptance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449584', 'cui_str': 'Opacification'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0085109', 'cui_str': 'Corneal neovascularization'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0086524', 'cui_str': 'Laser beam photocoagulation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0086524', 'cui_str': 'Laser beam photocoagulation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0085109', 'cui_str': 'Corneal neovascularization'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",15.0,0.017268,The study included 56 patients (56 eyes) with corneal opacifications of various etiology complicated by corneal neovascularization (CNV).,"[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Trufanov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Malozhen', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Krakhmaleva', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'Z V', 'Initials': 'ZV', 'LastName': 'Surnina', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Pivin', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Kasparova', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013604111']
1730,32777605,"The psychological impact of a nurse-led proactive self-care program on independent, non-frail community-dwelling older adults: A randomized controlled trial.","BACKGROUND


Poor mental health is common later in life and is a crucial factor in determining older adults' ability to live independently in the community. Existing nurse-led proactive self-care programs for older adults focus on physical health, since many are living with chronic diseases. Little is known about their effectiveness on the psychological outcomes of independent, non-frail community-dwelling older adults.
AIM


The aim of this study was to examine the impact of a nurse-led proactive self-care program with a health-social partnership model for community-dwelling older adults on depressive symptoms, life satisfaction, and the mental component of health-related quality of life.
DESIGN AND METHODS


This was a single-blinded, randomized controlled trial. Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included. Data were collected using questionnaires pre- (T1), post- (T2), and three month after the intervention (T3). The program provided a comprehensive assessment, health and self-management information, and empowerment, and promoted the accessibility of community services by building a health-social partnership network in the community. Generalized Estimating Equation was used to calculate the group, time, and interaction effects. Intention-to-treat was employed as the primary analysis in this study.
RESULTS


Of the 843 potential community-dwelling older adults who were assessed for eligibility, 457 eligible participants were randomized into the intervention (n = 230) or control group (n = 227). Among them, 175 (76.0%) participants in the intervention group and 190 (83.7%) participants in the control group completed data collection at T3, 6 months after T2 at the completion of the program. The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (Wald χ2 = 7.40, p = .007) in terms of the presence of depressive symptoms.
CONCLUSIONS


Interprofessional care addressing health and social needs improves the depressive symptoms among older adults dwelling in the community.",2020,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","['older adults', 'non-frail community-dwelling older adults', 'older adults dwelling in the community', 'community-dwelling older adults', 'frail community-dwelling older adults', '457 eligible participants', 'Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included', '843 potential community-dwelling older adults who were assessed for eligibility']","['Existing nurse-led proactive self-care programs', 'nurse-led proactive self-care program', 'nurse-led proactive self-care program with a health-social partnership model']","['depressive symptoms, life satisfaction, and the mental component of health-related quality of life', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",457.0,0.0758161,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Arkers.wong@polyu.edu.hk.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Frances.wong@polyu.edu.hk.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103724']
1731,32777606,Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.,"BACKGROUND


Opioid use disorder (OUD) is associated with cognitive dysfunction. Understanding how pharmacotherapy may affect cognition is an important treatment consideration.
METHODS


This was a hybrid residential-outpatient, randomized trial assessing transition regimens (naltrexone/buprenorphine [NTX/BUP] vs placebo-NTX/buprenorphine [PBO-N]/BUP) to extended-release naltrexone (XR-NTX) in patients with OUD seeking BUP discontinuation. Cognition was assessed at baseline, Day 22 (XR-NTX Day 14), and Day 36 (XR-NTX Day 28) using a range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance). Pre-specified exploratory analyses compared treatment groups. Post hoc analyses were treatment-arm-independent analyses overall and by baseline BUP dose (<8 mg/day [low-dose] or 8 mg/day [higher-dose]).
RESULTS


Baseline cognitive measures were similar between NTX/BUP and PBO-N/BUP groups and between BUP low-dose and higher-dose groups. There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed. Participants entering the study on low-dose BUP showed improvements at Day 36 relative to baseline in 5 of 7 cognitive outcomes; participants entering the study on higher-dose BUP generally did not show improvements in cognitive outcomes.
CONCLUSIONS


Improvements in most cognitive domains were associated with the transition from BUP to XR-NTX, particularly in participants entering the study on low-dose (<8 mg/day) BUP. These improvements may be due to the discontinuation of BUP, the treatment with XR-NTX, or both.",2020,"There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed.","['patients with OUD seeking BUP discontinuation', 'patients with opioid use disorder transitioned to extended-release injectable']","['naltrexone (XR-NTX', 'naltrexone', 'naltrexone/buprenorphine [NTX/BUP', 'buprenorphine', 'placebo-NTX/buprenorphine [PBO-N]/BUP']","['cognitive outcomes', 'range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance', 'Cognition', 'several cognitive outcomes', 'Cognitive performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",,0.0245195,"There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kosten', 'Affiliation': 'Baylor College of Medicine and MEDVAMC, Houston, TX, United States. Electronic address: kosten@bcm.edu.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Aharonovich', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, and The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Zavod', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Akerman', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lopez-Bresnahan', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Sullivan', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, and The New York State Psychiatric Institute, New York, NY, United States; Alkermes, Inc., Waltham, MA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106538']
1732,32777617,Longitudinal suicide ideation trajectories in a clinical trial of brief CBT for U.S. military personnel recently discharged from psychiatric hospitalization.,"Research among adolescent samples has suggested patterns of change in suicidal ideation (SI) following psychiatric hospitalization discharge are heterogenous and predictive of subsequent suicide attempts. However, no studies have examined SI trajectories following discharge among adult samples or the effect of treatment on trajectories. We used growth mixture modeling to examine trajectories of SI among 152 active duty military personnel in a randomized controlled trial comparing brief cognitive-behavioral therapy (CBT) for suicide prevention to treatment as usual following discharge from inpatient psychiatric hospitalization for a suicide risk. Analyses of SI at baseline, 3-, 6-, and 12-months post-discharge among the full sample randomized to both conditions revealed two trajectories: rapid improvers (59.21%) and gradual improvers (40.79%). Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge. Exploratory analyses suggested that, relative to those in the treatment as usual condition, those randomized to brief CBT in both trajectories may be less likely to make a suicide attempt during the follow-up period. Results replicate and extend prior research in identifying distinct ideation trajectories following psychiatric inpatient hospitalization for suicide risk to active-duty personnel in a treatment trial and linking these trajectories to suicide attempts during follow-up.",2020,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,['152 active duty military personnel'],['cognitive-behavioral therapy (CBT'],['Longitudinal suicide ideation trajectories'],"[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",152.0,0.135962,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, United States; VA Boston Healthcare System, Boston, MA, United States; Boston University School of Medicine, Boston, MA, United States. Electronic address: daniel.lee14@va.gov.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Memphis, Memphis, TN, United States.'}]",Psychiatry research,['10.1016/j.psychres.2020.113335']
1733,32777664,Digital application developed to evaluate functional results following robot-assisted radical prostatectomy: App for prostate cancer.,"INTRODUCTION


Mobile applications (""apps"") developed for smartphones and tablets are increasingly used in healthcare, allowing remote patient support or promoting self-health care. Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy. The main complications following surgery are urinary incontinence and erectile dysfunction. However, the exact numbers related to these morbidities are often missing due to brief interviews during consultations in the medical office. Therefore, the aim of this study was to create an app to determine whether response rates to pre- and post-surgical PC questionnaires will increase.
METHODS


The app was built using the IONIC framework system and provided to patients through a prospective randomized study. We included 100 patients divided into two groups: 1. first group used the app (n = 50); and 2. second group responded via validated printed questionnaires (control group) (n = 50). All patients received discharge counseling to respond to the questionnaires 1, 3, 6 and 12 months after the procedure. The app group received verbal guidance on how monitoring would occur, received an SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires.
RESULTS


The new app is called UroHealth and is available for download in the Apple App Store or at www.urohealth.com.br. When we evaluated the response rates, we found that 42.9% of the patients answered the preoperative questionnaire in the app group, while 16% responded in the control group (p = 0.003). By the end of the follow-up, we found that 24.5% of the patients answered the questionnaire in the app group, while 4% responded in the control group (p = 0.003).
CONCLUSION


This app enabled almost 6 times more patients to answer long-term follow-up questions after surgical procedures, providing high-quality information regarding morbidity related to treatment. Although our initial results indicate that this app may become a useful tool in obtaining more frequent and realistic answers, thus helping to improve surgical techniques, other ways of reaching the patient should be tested to achieve higher response rates.",2020,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.",['100 patients divided into two groups: 1. first group used the app (n\xa0=\xa050); and'],"['robot-assisted radical prostatectomy', 'SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires', 'verbal guidance', '2. second group responded via validated printed questionnaires (control group', 'discharge counseling']","['response rates', 'preoperative questionnaire', 'urinary incontinence and erectile dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",100.0,0.0209113,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.","[{'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Faria', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: lfaria83@gmail.com.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Reis', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Faculdade Atenas - Campus Passos, Minas Gerais, 37900-380, Brazil. Electronic address: sasareis@gmail.com.'}, {'ForeName': 'Katia R', 'Initials': 'KR', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: katiaramos@usp.br.'}, {'ForeName': 'José Arnaldo Shiomi', 'Initials': 'JAS', 'LastName': 'da Cruz', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: arnadolshiomi@yahoo.com.br.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Pimenta', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: ruanpimenta22@gmail.com.'}, {'ForeName': 'Nayara I', 'Initials': 'NI', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: nayara_viana_2@hotmail.com.'}, {'ForeName': 'Gabriela Q', 'Initials': 'GQ', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: gabriela.queiroz.amaral@gmail.com.'}, {'ForeName': 'Gabriel A G D', 'Initials': 'GAGD', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: arantes_gabriel@hotmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ilias', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: daniel.ilias22@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fakhouri', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: ffakhouri@gmail.com.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Xavier', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: geraldoxaviermed@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: srougi@uol.com.br.'}, {'ForeName': 'Carlo Camargo', 'Initials': 'CC', 'LastName': 'Passerotti', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: carlopasserotti@hotmail.com.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105683']
1734,32773013,"Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT.","BACKGROUND


Prostate cancer is the most common cancer among men in the UK. Prostate-specific antigen testing followed by biopsy leads to overdetection, overtreatment as well as undertreatment of the disease. Evidence of treatment effectiveness has lacked because of the paucity of randomised controlled trials comparing conventional treatments.
OBJECTIVES


To evaluate the effectiveness of conventional treatments for localised prostate cancer (active monitoring, radical prostatectomy and radical radiotherapy) in men aged 50-69 years.
DESIGN


A prospective, multicentre prostate-specific antigen testing programme followed by a randomised trial of treatment, with a comprehensive cohort follow-up.
SETTING


Prostate-specific antigen testing in primary care and treatment in nine urology departments in the UK.
PARTICIPANTS


Between 2001 and 2009, 228,966 men aged 50-69 years received an invitation to attend an appointment for information about the Prostate testing for cancer and Treatment (ProtecT) study and a prostate-specific antigen test; 82,429 men were tested, 2664 were diagnosed with localised prostate cancer, 1643 agreed to randomisation to active monitoring ( n  = 545), radical prostatectomy ( n  = 553) or radical radiotherapy ( n  = 545) and 997 chose a treatment.
INTERVENTIONS


The interventions were active monitoring, radical prostatectomy and radical radiotherapy.
TRIAL PRIMARY OUTCOME MEASURE


Definite or probable disease-specific mortality at the 10-year median follow-up in randomised participants.
SECONDARY OUTCOME MEASURES


Overall mortality, metastases, disease progression, treatment complications, resource utilisation and patient-reported outcomes.
RESULTS


There were no statistically significant differences between the groups for 17 prostate cancer-specific ( p  = 0.48) and 169 all-cause ( p  = 0.87) deaths. Eight men died of prostate cancer in the active monitoring group (1.5 per 1000 person-years, 95% confidence interval 0.7 to 3.0); five died of prostate cancer in the radical prostatectomy group (0.9 per 1000 person-years, 95% confidence interval 0.4 to 2.2 per 1000 person years) and four died of prostate cancer in the radical radiotherapy group (0.7 per 1000 person-years, 95% confidence interval 0.3 to 2.0 per 1000 person years). More men developed metastases in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring,  n  = 33 (6.3 per 1000 person-years, 95% confidence interval 4.5 to 8.8); radical prostatectomy,  n  = 13 (2.4 per 1000 person-years, 95% confidence interval 1.4 to 4.2 per 1000 person years); and radical radiotherapy,  n  = 16 (3.0 per 1000 person-years, 95% confidence interval 1.9 to 4.9 per 1000 person-years;  p  = 0.004). There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring ( n  = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy ( n  = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy ( n  = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years;  p  < 0.001). Radical prostatectomy had the greatest impact on sexual function/urinary continence and remained worse than radical radiotherapy and active monitoring. Radical radiotherapy's impact on sexual function was greatest at 6 months, but recovered somewhat in the majority of participants. Sexual and urinary function gradually declined in the active monitoring group. Bowel function was worse with radical radiotherapy at 6 months, but it recovered with the exception of bloody stools. Urinary voiding and nocturia worsened in the radical radiotherapy group at 6 months but recovered. Condition-specific quality-of-life effects mirrored functional changes. No differences in anxiety/depression or generic or cancer-related quality of life were found. At the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year, the probabilities that each arm was the most cost-effective option were 58% (radical radiotherapy), 32% (active monitoring) and 10% (radical prostatectomy).
LIMITATIONS


A single prostate-specific antigen test and transrectal ultrasound biopsies were used. There were very few non-white men in the trial. The majority of men had low- and intermediate-risk disease. Longer follow-up is needed.
CONCLUSIONS


At a median follow-up point of 10 years, prostate cancer-specific mortality was low, irrespective of the assigned treatment. Radical prostatectomy and radical radiotherapy reduced disease progression and metastases, but with side effects. Further work is needed to follow up participants at a median of 15 years.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN20141297.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 37. See the National Institute for Health Research Journals Library website for further project information.",2020,"There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring ( n  = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy ( n  = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy ( n  = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years;  p  < 0.001).","['Between 2001 and 2009, 228,966 men aged 50-69 years received an', 'men in the UK', ' n \u2009=\u2009545) and 997 chose a treatment', 'PSA-detected clinically localised prostate cancer', '82,429 men were tested, 2664 were diagnosed with localised prostate cancer, 1643 agreed to randomisation to active monitoring ( n \u2009=\u2009545', 'Prostate-specific antigen testing in primary care and treatment in nine urology departments in the UK', 'men aged 50-69 years']","['invitation to attend an appointment for information about the Prostate testing for cancer and Treatment (ProtecT) study and a prostate-specific antigen test', 'conventional treatments', 'radical prostatectomy and radical radiotherapy', 'localised prostate cancer (active monitoring, radical prostatectomy and radical radiotherapy', 'Active monitoring, radical prostatectomy and radical radiotherapy', 'Radical radiotherapy', 'radical prostatectomy ( n \u2009=\u2009553) or radical radiotherapy', 'Radical prostatectomy', 'Radical prostatectomy and radical radiotherapy', 'radical radiotherapy']","['17 prostate cancer-specific', 'Definite or probable disease-specific mortality', 'died of prostate cancer', 'Overall mortality, metastases, disease progression, treatment complications, resource utilisation and patient-reported outcomes', 'Sexual and urinary function', 'rates of disease progression', 'Bowel function', 'sexual function', 'anxiety/depression or generic or cancer-related quality of life', 'disease progression and metastases', 'Urinary voiding and nocturia', 'sexual function/urinary continence', 'prostate cancer-specific mortality']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517809', 'cui_str': '545'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0587531', 'cui_str': 'Urology department'}]","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0542565', 'cui_str': 'Bladder control'}]",228966.0,0.168612,"There were higher rates of disease progression in the active monitoring group than in the radical prostatectomy and radical radiotherapy groups: active monitoring ( n  = 112; 22.9 per 1000 person-years, 95% confidence interval 19.0 to 27.5 per 1000 person years); radical prostatectomy ( n  = 46; 8.9 per 1000 person-years, 95% confidence interval 6.7 to 11.9 per 1000 person-years); and radical radiotherapy ( n  = 46; 9.0 per 1000 person-years, 95% confidence interval 6.7 to 12.0 per 1000 person years;  p  < 0.001).","[{'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wade', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blazeby', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology and Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Doble', 'Affiliation': ""Department of Urology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': ""Department of Urology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Powell', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Prescott', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Rosario', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24370']
1735,32773732,Effects of Cognitive Task Training on Dynamic Balance and Gait of Patients with Stroke: A Preliminary Randomized Controlled Study.,"BACKGROUND The decreased postural control ability of stroke patients affects their ability to balance in various postures such as sitting and standing. This study aimed to determine whether cognitive task training for stroke patients is effective in improving walking and balancing abilities. MATERIAL AND METHODS Seventeen stroke patients (10 males, 7 females) were randomized by ballot to be assigned to the cognitive task group (CBT) or the general task group (GBT). For the cognitive task training, a dual task of balance and cognition using traffic signals, a familiar form to the subjects, was applied as a program. In both groups the interventions were performed for 30 min a day, 3 times a week, for 4 weeks. The timed up and go test (TUG), the Berg balance scale (BBS), and gait ability evaluation were performed to compare the therapeutic effects. RESULTS After the intervention, the BBS showed significant differences in both groups (p<0.05). The cognitive task training group had significant improvement in all outcome scores after the intervention (p<0.05). The TUG score of the CBT group significantly decreased to 6.17 s (p<0.05), but that of the GBT showed no statistically significant change. CONCLUSIONS Cognitive task training could be used in clinical rehabilitation as a more effective intervention method to improve balance and gait ability of stroke patients.",2020,"The TUG score of the CBT group significantly decreased to 6.17 s (p<0.05), but that of the GBT showed no statistically significant change.","['Patients with Stroke', 'stroke patients', 'Seventeen stroke patients (10 males, 7 females']","['Cognitive task training', 'Cognitive Task Training', 'cognitive task group (CBT) or the general task group (GBT', 'cognitive task training']","['Berg balance scale (BBS), and gait ability evaluation', 'Dynamic Balance and Gait', 'postural control ability', 'TUG score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0111076,"The TUG score of the CBT group significantly decreased to 6.17 s (p<0.05), but that of the GBT showed no statistically significant change.","[{'ForeName': 'Su-Yeon', 'Initials': 'SY', 'LastName': 'Hong', 'Affiliation': 'Department of Physical Therapy, Cheongju IM Rehabilitation Hospital, Cheongju, South Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, The Graduate School, Daejeon University, Daejeon, South Korea.'}, {'ForeName': 'Jong-Duk', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Daejeon, South Korea.'}]",Medical science monitor basic research,['10.12659/MSMBR.925264']
1736,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China. Electronic address: tina_yai@126.com.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1737,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
1738,32781371,A pragmatic randomised controlled trial of the fostering changes programme.,"BACKGROUND


Many looked after young people in Wales are cared for by foster or kinship carers, usually as a consequence of maltreatment or developmentally traumatising experiences within a family context. Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
OBJECTIVE


To determine whether group-based training improves foster carer self-efficacy.
PARTICIPANTS AND SETTING


Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks. Carers from households where one or more carer had previously attended the training were not eligible. Sixteen local authorities and three independent fostering providers in Wales took part.
METHODS


The primary outcome measure was the Carer Efficacy Questionnaire assessed at 12 months. Secondary outcomes included the Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves.
RESULTS


312 consented foster carers were allocated to FC (n = 204) or usual care (n = 108) group. 65.3 % of FC group participants attended sufficient training sessions (8/12, including sessions three and four). There were no differences in carer-reported self-efficacy at 12 months (adjusted difference in means (95 % CI): -0.19 (-1.38 to 1.00)). Small differences in carer-reported child behaviour difficulties and carer coping strategies over time favoured the intervention but these effects diminished from three to 12 months. No other intervention effects were observed.
CONCLUSIONS


Although well-received by participants, training was associated with small and mostly short-term benefit for trial secondary outcomes.",2020,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","['Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks', 'Sixteen local authorities and three independent fostering providers in Wales took part', '312 consented foster carers']","['usual care', 'FC']","['foster carer self-efficacy', 'carer-reported self-efficacy', 'Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves', 'Carer Efficacy Questionnaire']","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.166724,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","[{'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom, Wales. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: Scourfield@cardiff.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104646']
1739,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
1740,32782008,Predictors of low back disability in chiropractic and physical therapy settings.,"BACKGROUND


Predicting ongoing disability for chronic non-specific low back pain (LBP) is important to avoid prolonged disability.
OBJECTIVE


Determine predictors of disability at 6 month follow-up in patients with LBP at medium risk of ongoing disability.
METHODS


Baseline data was collected from 108 patients with medium-risk chronic non-specific LBP (mean age 50.4 years, SD 13.6) from six private chiropractic and physiotherapy clinics in Australia who took part in a randomised control trial. All patients received a pragmatic course of multimodal physical treatments [e.g., manual therapy (spinal manipulation or mobilization and/or soft tissue massage)] combined with advice, education and exercise. Baseline prognostic variables included sociodemographic, physical and psychological characteristics. Primary outcome was disability (Roland Morris Disability) at 6 month follow-up. Multivariable linear regression analysis was conducted.
RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70; p < 0.0001) and consultation with a medical specialist for back pain in the preceding 3 months (β = 3.35, 95% CI 1.14 to 5.55; p < 0.003), which significantly predicted higher disability at 6 months (unadjusted R  2  = 0.31). Those with a lower work ability (scale 1 to 10) and who had seen a medical specialist for their back pain were more likely to report greater LBP-related disability at 6 months.
CONCLUSION


Patients with chronic LBP presenting to primary care with lower work ability and recent consultation with a medical specialist for LBP are more likely to have a worse prognosis; these are indicators to clinicians that standard conservative care may not adequately manage the patients' needs.",2020,"RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70;","['patients with LBP at medium risk of ongoing disability', 'Patients with chronic LBP presenting to primary care with lower work ability and recent consultation with a medical specialist for LBP', '108 patients with medium-risk chronic non-specific LBP (mean age 50.4\u2009years, SD 13.6) from six private chiropractic and physiotherapy clinics in Australia who took part in a randomised control trial']","['multimodal physical treatments [e.g., manual therapy (spinal manipulation or mobilization and/or soft tissue massage)] combined with advice, education and exercise']","['sociodemographic, physical and psychological characteristics', 'consultation with a medical specialist for back pain', 'disability (Roland Morris Disability', 'disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0556852', 'cui_str': 'Soft tissue massage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",108.0,0.0812215,"RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70;","[{'ForeName': 'M John', 'Initials': 'MJ', 'LastName': 'Petrozzi', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia. mpet9893@uni.sydney.edu.au.'}, {'ForeName': 'Sidney M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leaver', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Mackey', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00328-3']
1741,32783238,"Suppression of Helicobacter pylori infection by daily cranberry intake: A double-blind, randomized, placebo-controlled trial.","BACKGROUND AND AIM


Dietary strategies that contribute to reducing incidence of Helicobacter pylori infection without negative side effects are highly desirable owing to worldwide bacterial prevalence and carcinogenesis potential. The aim of this study was to determine dosage effect of daily cranberry consumption on H. pylori suppression over time in infected adults to assess the potential of this complementary management strategy in a region with high gastric cancer risk and high prevalence of H. pylori infection.
METHODS


This double-blind, randomized, placebo-controlled trial on 522 H. pylori-positive adults evaluated dose-response effects of proanthocyanidin-standardized cranberry juice, cranberry powder, or their placebos on suppression of H. pylori at 2 and 8 weeks by  13  C-urea breath testing and eradication at 45 days post-intervention.
RESULTS


H. pylori-negative rates in placebo, low-proanthocyanidin, medium-proanthocyanidin, and high-proanthocyanidin cranberry juice groups at week 2 were 13.24%, 7.58%, 1.49%, and 13.85% and at week 8 were 7.35%, 7.58%, 4.48%, and 20.00%, respectively. Consumption of high-proanthocyanidin juice twice daily (44 mg proanthocyanidin/240-mL serving) for 8 weeks resulted in decreased H. pylori infection rate by 20% as compared with other dosages and placebo (P < 0.05). Percentage of H. pylori-negative participants increased from 2 to 8 weeks in subjects who consumed 44 mg proanthocyanidin/day juice once or twice daily, showing a statistically significant positive trend over time. Encapsulated cranberry powder doses were not significantly effective at either time point. Overall trial compliance was 94.25%. Cranberry juice and powder were well-tolerated.
CONCLUSIONS


Twice-daily consumption of proanthocyanidin-standardized cranberry juice may help potentiate suppression of H. pylori infection.
TRIAL REGISTRATION


ChiCTR1800017522, per WHO ICTRP.",2020,"Percentage of H. pylori-negative participants increased from 2 to 8 weeks in subjects that consumed 44 mg proanthocyanidin/day juice once or twice daily, showing a statistically significant positive trend over time.","['a region with high gastric cancer risk and high prevalence of H. pylori infection', '522 H. pylori-positive adults', 'infected adults']","['Daily Cranberry Intake', 'Placebo', 'daily cranberry consumption', 'high-proanthocyanidin juice', 'proanthocyanidin-standardized cranberry juice', 'proanthocyanidin-standardized cranberry juice, cranberry powder or their placebos', 'proanthocyanidin', 'placebo, low-, medium- and high-proanthocyanidin cranberry juice', 'placebo']","['suppression of H. pylori', 'tolerated', 'Percentage of H. pylori-negative participants', 'Overall trial compliance', 'H. pylori infection rate']","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C1572601', 'cui_str': 'CRANBERRY JUICE'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]",522.0,0.518413,"Percentage of H. pylori-negative participants increased from 2 to 8 weeks in subjects that consumed 44 mg proanthocyanidin/day juice once or twice daily, showing a statistically significant positive trend over time.","[{'ForeName': 'Zhe-Xuan', 'Initials': 'ZX', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jun-Ling', 'Initials': 'JL', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Liu', 'Affiliation': 'Office for Gastric Cancer Prevention, Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Office for Gastric Cancer Prevention, Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Lan-Fu', 'Initials': 'LF', 'LastName': 'Zhang', 'Affiliation': 'Office for Gastric Cancer Prevention, Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jing-Ying', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ha-Er', 'Initials': 'HE', 'LastName': 'Gao', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Dong-Man', 'Initials': 'DM', 'LastName': 'Ye', 'Affiliation': 'Department of Medical Imaging, Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'You', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15212']
1742,32780643,"Patient-reported outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated  EGFR -mutated metastatic non-small-cell lung cancer.","OBJECTIVE


In the phase 3 RELAY trial, ramucirumab/erlotinib demonstrated superior progression-free survival (PFS) over placebo/erlotinib in patients with  EGFR -mutated metastatic NSCLC (median PFS 19.4 versus 12.4 months; HR = 0.59, 95% CI = 0.46-0.76;  p  < .0001). Safety was consistent with established profiles for ramucirumab and erlotinib in NSCLC. Here, we present patient-reported outcomes.
METHODS


Patients received oral erlotinib (150 mg daily) plus intravenous ramucirumab (10 mg/kg) or placebo Q2W until progressive disease or unacceptable toxicity. Patients completed the Lung Cancer Symptom Scale (LCSS) and EQ-5D questionnaires at baseline and every other cycle. Analyses included time to deterioration (TtD) for LCSS via Kaplan-Meier method and Cox models and changes from baseline using mixed-model repeated-measures regression analysis.
RESULTS


Overall patient compliance for LCSS and EQ-5D was >95%. TtD did not differ between treatment arms for LCSS Total Score (HR = 0.962, 95% CI = 0.690-1.343) and Average Symptom Burden Index (HR = 1.012, 95% CI = 0.732-1.400). TtD of individual LCSS items (appetite loss, fatigue, cough, shortness of breath, pain, symptom distress, difficulties with daily activities, quality of life) indicated no difference between arms; however, patient-reported blood in sputum was worse for ramucirumab/erlotinib (HR = 1.987, 95% CI = 1.206-3.275). Results of LCSS mean changes from baseline were consistent with TtD, indicating no significant differences between treatment arms except for blood in sputum. Mean changes from baseline in EQ-5D index score ( p  = .94) and visual analogue scale ( p  = .95) revealed no overall differences in health status between treatment arms.
CONCLUSIONS


Patients' overall quality of life and symptom burden did not differ with the addition of ramucirumab to erlotinib compared to placebo/erlotinib. These data support the clinical benefit of ramucirumab/erlotinib in untreated  EGFR -mutated metastatic NSCLC.",2020,Mean changes from baseline in EQ-5D index score (p = 0.94) and visual analogue scale (p = 0.95) revealed no overall differences in health status between treatment arms.,[],"['placebo/erlotinib', 'ramucirumab/erlotinib', 'placebo Q2W', 'oral erlotinib (150\u2009mg daily) plus intravenous ramucirumab', 'placebo plus erlotinib']","['overall quality-of-life and symptom burden', 'superior progression-free survival (PFS', 'Overall patient compliance for LCSS and EQ-5D', 'LCSS Total Score', 'visual analogue scale', 'TtD of individual LCSS items (appetite loss, fatigue, cough, shortness of breath, pain, symptom distress, difficulties with daily activities, quality-of-life', 'blood-in-sputum', 'health status', 'Lung Cancer Symptom Scale (LCSS) and EQ-5D questionnaires', 'time-to-deterioration (TtD) for LCSS via Kaplan-Meier method and Cox models', 'Average Symptom Burden Index', 'EQ-5D index score', 'LCSS mean changes']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012772', 'cui_str': 'Disulfiram'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.423814,Mean changes from baseline in EQ-5D index score (p = 0.94) and visual analogue scale (p = 0.95) revealed no overall differences in health status between treatment arms.,"[{'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lungen Clinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles/TRIO-US Network, Los Angeles, CA, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce Aix', 'Affiliation': 'Hospital Universitario, CNIO Lung Cancer Clinical Research Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Winfree', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Frimodt-Moller', 'Affiliation': 'Eli Lilly and Company, Copenhagen, Denmark.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Visseren-Grul', 'Affiliation': 'Lilly Oncology, Utrecht, Netherlands.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Current medical research and opinion,['10.1080/03007995.2020.1808781']
1743,32788567,Levosimendan in the treatment of patients with acute cardiac conditions: an expert opinion of the Association of Intensive Cardiac Care of the Polish Cardiac Society.,"Levosimendan is a new inodilator which involves 3 main mechanisms: increases the calcium sensitivity of cardiomyocytes, acts as a vasodilator due to the opening of potassium channels, and has a cardioprotective effect. Levosimendan is mainly used in the treatment of acute decompensated heart failure (class IIb recommendation according to the European Society of Cardiology guidelines). However, numerous clinical trials indicate the validity of repeated infusions of levosimendan in patients with stable heart failure as a bridge therapy to heart transplantation, and in patients with accompanying right ventricular heart failure and pulmonary hypertension. Due to the complex mechanism of action, including the cardioprotective and anti- -aggregating effect, the use of levosimendan may be particularly beneficial in acute coronary syndromes, preventing the occurrence of acute heart failure. There are data indicating that levosimendan administered prior to cardiac surgery may improve outcomes in patients with severely impaired left ventricular function. The multidirectional mechanism of action also affects other organs and systems. The positive effect of levosimendan in the treatment of cardiorenal and cardiohepatic syndromes has been shown. It has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis. However, with inconclusive results of previous studies, there is aneed for awell-designed multicenter randomized placebo-‑controlled study, including an adequately large group of outpatients with chronic advanced systolic heart failure.",2020,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","['patients with accompanying right ventricle heart failure and pulmonary hypertension', 'patients with stable heart failure', 'patients with acute coronary syndromes', 'patients with severely impaired left ventricle function', 'patients with acute cardiac conditions', 'outpatients with chronic advanced systolic heart failure']","['levosimendan', 'Levosimendan', 'levosimandan', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0197177,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Tycińska', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Gierlotka', 'Affiliation': ''}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Bugajski', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Deja', 'Affiliation': ''}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Depukat', 'Affiliation': ''}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': ''}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Grześk', 'Affiliation': ''}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Kasprzak', 'Affiliation': ''}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kucewicz-Czech', 'Affiliation': ''}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Leszek', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Płonka', 'Affiliation': ''}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Sobkowicz', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Straburzyńska-Migaj', 'Affiliation': ''}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wilk', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zawiślak', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zymliński', 'Affiliation': ''}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stępińska', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15551']
1744,32789723,Comparison of different types of covered self-expandable metal stents for malignant colorectal obstruction.,"BACKGROUND


Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi).
METHODS


We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed.
RESULTS


A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups.
CONCLUSIONS


Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.",2020,"Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups.
","['Patients with malignant colorectal obstruction were eligible for the study', 'A total of 60 patients were included (mean age, 70.5\u2009±\u200912.5\xa0years; male, 31 [51.7', 'malignant colorectal obstruction', 'four tertiary referral centers between July 2016 and April 2018']","['covered self-expandable metal stents', 'flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi']","['Migration', 'risk of other complications, including perforation and re-obstruction', 'effectiveness and complication rates', 'Rates of technical success, clinical success, and complications', 'clinical success rates', 'technical success rates', 'migration rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",60.0,0.176818,"Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups.
","[{'ForeName': 'Joon Seop', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hyun Seok', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Eun Soo', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea. dandy813@hanmail.net.'}, {'ForeName': 'Min Kyu', 'Initials': 'MK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jin Tae', 'Initials': 'JT', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ho Gak', 'Initials': 'HG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Dong Wook', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Dae Jin', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Fatima Hospital of Daegu, Daegu, South Korea.'}, {'ForeName': 'Yoo Jin', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Chang Heon', 'Initials': 'CH', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Dongguk University School of Medicine, Gyeongju, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-020-07869-x']
1745,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
1746,32795623,Effects of flexibility and strength training on peak hamstring musculotendinous strains during sprinting.,"BACKGROUND


Hamstring injury is 1 of the most common injuries in sports involving sprinting. Hamstring flexibility and strength are often considered to be modifiable risk factors in hamstring injury. Understanding the effects of hamstring flexibility or strength training on the biomechanics of the hamstring muscles during sprinting could assist in improving prevention strategies and rehabilitation related to these injuries. The purpose of this study was to determine the effects of altering hamstring flexibility or strength on peak hamstring musculotendinous strain during sprinting.
METHODS


A total of 20 male college students (aged 18-24 years) participated and were randomly assigned to either a flexibility-intervention group or a strength-intervention group. Each participant executed exercise training 3 times a week for 8 weeks. Flexibility, sprinting, and isokinetic strength testing were performed before and after the 2 interventions. Paired t tests were performed to determine hamstring flexibility or strength intervention effects on optimal hamstring musculotendinous lengths and peak hamstring musculotendinous strains during sprinting.
RESULTS


Participants in the flexibility intervention group significantly increased the optimal musculotendinous lengths of the semimembranosus and biceps long head (p ≤ 0.026) and decreased peak musculotendinous strains in all 3 bi-articulate hamstring muscles (p ≤ 0.004). Participants in the strength-intervention group significantly increased the optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
CONCLUSION


Increasing hamstring flexibility or strength through exercise training may assist in reducing the risk of hamstring injury during sprinting for recreational male athletes.",2020,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","['peak hamstring musculotendinous strains during sprinting', '20 male college students (aged 18-24 years', 'recreational male athletes']","['exercise training', 'flexibility intervention group or a strength intervention group', 'flexibility and strength training', 'hamstring flexibility or strength', 'hamstring flexibility or strength training']","['peak musculotendinous strains', 'peak musculotendinous strain', 'Hamstring flexibility and strength', 'optimal musculotendinous lengths of the semimembranosus and biceps long head', 'optimal musculotendinous lengths of all 3 hamstring muscles', 'Flexibility, sprinting and isokinetic strength testing']","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0224452', 'cui_str': 'Semimembranosus muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",20.0,0.0138512,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","[{'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Shangxiao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Best', 'Affiliation': 'UHealth Sports Medicine Institute, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China. Electronic address: lihanjun@bsu.edu.cn.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Center for Human Movement Science, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7135, USA. Electronic address: byu@med.unc.edu.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.08.001']
1747,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
1748,32789935,Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment.,"The aim of this study is to ascertain whether the simultaneous measurement of hemoglobin O 2  saturation (StO 2  ) and dimension of venous leg ulcers (VLU) by near infrared spectroscopy (NIRS) imaging can predict the healing course with protocols employing a conventional treatment alone or in combination with hyperbaric oxygen therapy (HBOT). NIRS 2D images of wound region were obtained in 81 patients with hard-to-heal VLU that had been assigned, in a randomized controlled clinical trial, to the following protocols: 30 HBOT sessions, adjunctive to the conventional therapy, either twice daily over 3 weeks (group A) or once daily over 6 weeks (group B), and conventional therapy without HBOT (group C). Seventy-three patients completed the study with a total of 511 NIRS images being analyzed. At the end of treatment, wound area was significantly smaller in all three groups. However, at the 3-week mark the wound area reduction tended to be less evident in group A than in the other groups. This trend continued up to the 6-week end-point when a significantly greater area reduction was found with group B (65.5%) and group C (56.8%) compared to group A (29.7%) (P < .01). Furthermore, a higher incidence of complete healing was noted with group B (20%) than with group A (4.5%) and group C (3.8%). When using a final wound reduction in excess of 40% to distinguish healing from nonhealing ulcers, it was found that only the former present NIRS StO 2  values abating over the study period both at center and edge of lesions. In conclusion, NIRS analysis of StO 2  and wound area can predict the healing course of VLU. Adjunctive HBOT significantly facilitates VLU healing compared to the conventional treatment alone. This positive action, however, becomes manifest only with a longer and less intensive treatment schedule.",2020,This trend continued up to the 6-week end-point when a significantly greater area reduction was found with Group B (65.5%) and Group C (56.8%) compared to Group A (29.7%) (p<0.01).,"['Seventy-three patients completed the study with a total of 511 NIRS images being analyzed', '81 patients with hard-to-heal VLU']","['Hyperbaric Oxygen Therapy (HBOT', 'Adjunctive HBOT', 'conventional with Hyperbaric Oxygen treatment', 'conventional therapy without HBOT', 'hemoglobin O 2  saturation (StO 2  ) and dimension of venous leg ulcers (VLU) by Near Infrared Spectroscopy (NIRS) imaging']","['healing course of VLU', 'area reduction', 'wound area', 'complete healing', 'VLU healing']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321170', 'cui_str': 'Hemoglobin O'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",81.0,0.0281359,This trend continued up to the 6-week end-point when a significantly greater area reduction was found with Group B (65.5%) and Group C (56.8%) compared to Group A (29.7%) (p<0.01).,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Longobardi', 'Affiliation': 'Centro Iperbarico, Ravenna, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Hartwig', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Santarella', 'Affiliation': 'Centro Iperbarico, Bologna, Italy.'}, {'ForeName': 'Klarida', 'Initials': 'K', 'LastName': 'Hoxha', 'Affiliation': 'Centro Iperbarico, Ravenna, Italy.'}, {'ForeName': 'Jhonny', 'Initials': 'J', 'LastName': 'Campos', 'Affiliation': 'Centro Iperbarico, Ravenna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Laurino', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Salvo', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa, Italy.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Trivella', 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Coceani', 'Affiliation': ""Istituto Scienze della Vita, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rocco', 'Affiliation': 'Dipartimento di Scienze Medico-Chirurgiche e di Medicina Traslazionale, Università degli Studi di Roma ""La Sapienza"", Roma, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': ""L'Abbate"", 'Affiliation': 'Istituto di Fisiologia Clinica-CNR, Pisa, Italy.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12853']
1749,32783547,Vitamin D: does it help Tregs in active rheumatoid arthritis patients.,"Background Regulatory T cells (Tregs) play an important role in the maintenance of immunological tolerance. Tregs deficiency or suppressor functions reduction may be associated with autoimmune diseases development. Objectives To estimate the effect of vitamin D supplementation on Tregs level in the peripheral blood of active rheumatoid arthritis (RA) patients. Methods 40 active RA patients were randomly assigned into two groups. Group I received methotrexate (MTX) plus hydroxychloroquine, group II received MTX, hydroxychloroquine plus vitamin D supplementation for 3 months, and 30 healthy volunteers as control group. Peripheral blood Tregs were measured at baseline and after 3 months by Flow Cytometry. Results At baseline, Tregs percentage was significantly decreased (p<0.001) in both RA patient groups (13.52±1.95%, 13.65±2.98% respectively), compared to controls (28.44±7.37%) with no significant difference between the two patient groups (p=0.866). After 3 months, there was a significant elevation in Tregs percentage in group II compared to group I (p<0.001). Tregs elevation was associated with significant DAS-28 score reduction (p<0.001). Conclusion Vitamin D appears to have important immunomodulatory functions. Vitamin D supplementation can be combined safely with traditional DMARDs to regulate the immune system. Clinical trial registration Tanta University Protocol Record 33846, Vitamin D Effect in Rheumatoid Arthritis, http://www.clinicaltrials.gov, NCT04472481.",2020,"At baseline, the percentage of Tregs was significantly decreased (p<0.001) in both groups of RA patients (13.52 ±1.95 % and 13.65 ±2.98 % respectively), in comparison to controls (28.44 ±7.37%) with no significant difference between the two patient groups (p=0.866).","['active rheumatoid arthritis patients', '40 patients with active RA', 'active rheumatoid arthritis (RA) patients', 'Rheumatoid Arthritis', '30 healthy volunteers as a control group']","['Vitamin D', 'vitamin D supplementation', 'methotrexate (MTX) plus hydroxychloroquine', 'MTX and hydroxychloroquine plus vitamin D supplementation']","['percentage of Tregs', 'Peripheral blood Tregs', 'DAS-28 score reduction']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",30.0,0.223212,"At baseline, the percentage of Tregs was significantly decreased (p<0.001) in both groups of RA patients (13.52 ±1.95 % and 13.65 ±2.98 % respectively), in comparison to controls (28.44 ±7.37%) with no significant difference between the two patient groups (p=0.866).","[{'ForeName': 'Hanaa Samy', 'Initials': 'HS', 'LastName': 'El-Banna', 'Affiliation': 'Faculty of Medicine, Tanta University , Tanta, Egypt.'}, {'ForeName': 'Souzan Ezzat', 'Initials': 'SE', 'LastName': 'Gado', 'Affiliation': 'Faculty of Medicine, Tanta University , Tanta, Egypt.'}]",Expert review of clinical immunology,['10.1080/1744666X.2020.1805317']
1750,32785021,A Five-Ingredient Nutritional Supplement and Home-Based Resistance Exercise Improve Lean Mass and Strength in Free-Living Elderly.,"Old age is associated with lower physical activity levels, suboptimal protein intake, and desensitization to anabolic stimuli, predisposing for age-related muscle loss (sarcopenia). Although resistance exercise (RE) and protein supplementation partially protect against sarcopenia under controlled conditions, the efficacy of home-based, unsupervised RE (HBRE) and multi-ingredient supplementation (MIS) is largely unknown. In this randomized, placebo-controlled and double-blind trial, we examined the effects of HBRE/MIS on muscle mass, strength, and function in free-living, older men. Thirty-two sedentary men underwent twelve weeks of home-based resistance band training (3 d/week), in combination with daily intake of a novel five-nutrient supplement ('Muscle5'; M5,  n  = 16, 77.4 ± 2.8 y) containing whey, micellar casein, creatine, vitamin D, and omega-3 fatty acids, or an isocaloric/isonitrogenous placebo (PLA;  n  = 16, 74.4 ± 1.3 y), containing collagen and sunflower oil. Appendicular and total lean mass (ASM; +3%, TLM; +2%), lean mass to fat ratios (ASM/% body fat; +6%, TLM/% body fat; +5%), maximal strength (grip; +8%, leg press; +17%), and function (5-Times Sit-to-Stand time; -9%) were significantly improved in the M5 group following HBRE/MIS therapy (pre vs. post tests;  p  < 0.05). Fast-twitch muscle fiber cross-sectional areas of the quadriceps muscle were also significantly increased in the M5 group post intervention (Type IIa; +30.9%, Type IIx, +28.5%,  p  < 0.05). Sub-group analysis indicated even greater gains in total lean mass in sarcopenic individuals following HBRE/MIS therapy (TLM; +1.65 kg/+3.4%,  p  < 0.05). We conclude that the Muscle5 supplement is a safe, well-tolerated, and effective complement to low-intensity, home-based resistance exercise and improves lean mass, strength, and overall muscle quality in old age.",2020,"Sub-group analysis indicated even greater gains in total lean mass in sarcopenic individuals following HBRE/MIS therapy (TLM; +1.65 kg/+3.4%,  p  < 0.05).","['free-living, older men', 'Thirty-two sedentary men']","['HBRE/MIS', 'containing collagen and sunflower oil', 'Muscle5 supplement', ""home-based resistance band training (3 d/week), in combination with daily intake of a novel five-nutrient supplement ('Muscle5'; M5,  n  = 16, 77.4 ± 2.8 y) containing whey, micellar casein, creatine, vitamin D, and omega-3 fatty acids, or an isocaloric/isonitrogenous placebo"", 'Home-Based Resistance Exercise Improve', 'resistance exercise (RE) and protein supplementation', 'placebo']","['lean mass to fat ratios', 'muscle mass, strength, and function', 'Lean Mass and Strength', 'Appendicular and total lean mass', 'Fast-twitch muscle fiber cross-sectional areas of the quadriceps muscle', 'maximal strength', 'total lean mass', 'safe, well-tolerated, and effective complement to low-intensity, home-based resistance exercise and improves lean mass, strength, and overall muscle quality']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242873', 'cui_str': 'Skeletal muscle fiber, type II'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",32.0,0.0485037,"Sub-group analysis indicated even greater gains in total lean mass in sarcopenic individuals following HBRE/MIS therapy (TLM; +1.65 kg/+3.4%,  p  < 0.05).","[{'ForeName': 'Mats I', 'Initials': 'MI', 'LastName': 'Nilsson', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mikhail', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Di Carlo', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Bethanie', 'Initials': 'B', 'LastName': 'Hamilton', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Barnard', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Bart P', 'Initials': 'BP', 'LastName': 'Hettinga', 'Affiliation': 'Exerkine Corporation, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hatcher', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Milla G', 'Initials': 'MG', 'LastName': 'Tarnopolsky', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Nederveen', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Bujak', 'Affiliation': 'Exerkine Corporation, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'May', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Tarnopolsky', 'Affiliation': 'Department of Pediatrics, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.'}]",Nutrients,['10.3390/nu12082391']
1751,32785514,ERRATUM: Patient safety: within the reach of the homeless?,,2020,,[],[],[],[],[],[],,0.0221623,,[],Revista brasileira de enfermagem,['10.1590/0034-7167.202073n6e10']
1752,32794259,The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in Nonalcoholic Steatohepatitis.,"BACKGROUND & AIMS


The composition of the human gut microbiota is linked to health and disease, and knowledge of the impact of therapeutics on the microbiota is essential to decipher their biological roles and to gain new mechanistic insights. Here we report the effect of aldafermin, an analog of the gut hormone FGF19, versus placebo on the gut microbiota in a prospective, phase 2 study in patients with NASH.
APPROACH & RESULTS


176 patients with biopsy-confirmed NASH (NAS ≥4), fibrosis (F1-F3 by NASH CRN criteria) and elevated liver fat content (≥8% by MRI-PDFF) received 0.3 mg (n=23), 1 mg (n=49), 3 mg (n=49), 6 mg (n=28) aldafermin or placebo (n=27) for 12 weeks. Stool samples were collected on day 1 and week 12 and profiled using 16S rRNA gene sequencing; 122 patients had paired stool microbiome profiles at both day 1 and week 12. Overall, the state of the gut microbial community was distinctly stable in patients treated with aldafermin, with all major phyla and genera unaltered during therapy. Patients treated with aldafermin showed a significant, dose-dependent enrichment in the rare genus Veillonella, a commensal microbe known to have lactate-degrading and performance-enhancing properties, which correlated with changes in serum bile acid profile.
CONCLUSIONS


Veillonella may be a bile acid-sensitive bacteria whose enrichment is enabled by aldafermin-mediated suppression of bile acid synthesis and in particular, decreases in toxic bile acids. This study provides an integrated analysis of gut microbiome, serum bile acid metabolome, imaging and histological measurements in clinical trials testing aldafermin for NASH. Our results reveal novel biology and provide better understanding of the intricacies of microbiome-host interactions.",2020,"Patients treated with aldafermin showed a significant, dose-dependent enrichment in the rare genus Veillonella, a commensal microbe known to have lactate-degrading and performance-enhancing properties, which correlated with changes in serum bile acid profile.
","['176 patients with biopsy-confirmed NASH (NAS ≥4), fibrosis (F1-F3 by NASH CRN criteria) and elevated liver fat content (≥8% by MRI-PDFF', 'patients with NASH']","['aldafermin', 'aldafermin or placebo', 'placebo']","['state of the gut microbial community', 'Stool samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0027446', 'cui_str': 'National Academy of Sciences (U.S.)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}]",176.0,0.0410101,"Patients treated with aldafermin showed a significant, dose-dependent enrichment in the rare genus Veillonella, a commensal microbe known to have lactate-degrading and performance-enhancing properties, which correlated with changes in serum bile acid profile.
","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, University of California, San Diego, United States.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Duy M', 'Initials': 'DM', 'LastName': 'Dinh', 'Affiliation': 'Diversigen, Houston, United States.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'DePaoli', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Hsiao D', 'Initials': 'HD', 'LastName': 'Lieu', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'University of Oxford, London, United Kingdom.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond, United States.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31523']
1753,32794673,[Optimized preparation method of leukocytes-rich platelet-rich plasma by varying conditions during centrifugation].,"Objective


To identify a more popularized preparation protocol of leukocytes-rich platelet-rich plasma (L-PRP) for higher tolerance rate.
Methods


The peripheral blood samples of 76 volunteers (45.0 mL/case) were mixed with 5 mL sodium citrate injection for blood transfusion, and L-PRP was prepared by twice centrifugations. All blood samples were divided into three groups according to the parameters of twice centrifugation: experimental group A (12 cases, 400×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time), experimental group B (27 cases, 800×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time), and control group (37 cases, 1 360×  g , 10 minutes for the first time and 1 360×  g , 10 minutes for the second time). The platelet recovery rate and platelet and leukocyte enrichment coefficient of L-PRP in each group were calculated and compared.
Results


After removal of abnormal blood samples (platelet recovery rate was more than 100% or white thrombus), the remaining 55 cases were included in the statistical analysis, including 10 cases in experimental group A, 21 cases in experimental group B, and 24 cases in control group. The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05). There was no significant difference in leukocyte enrichment coefficient between experimental groups A, B, and control group (  P >0.05).
Conclusion


The preparation quality of PRP is affected by various factors, including centrifugal force, centrifugal time, temperature, and operation process,  etc . Twice centrifugation (800×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time) is an ideal and feasible centrifugation scheme, which can obtain satisfactory platelet recovery rate and enrichment coefficient with thicker buffy coat, which can reduce the fine operation requirements for operators, improve the fault tolerance rate and generalization.",2020,The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05).,['76 volunteers (45.0 mL/case'],"['leukocytes-rich platelet-rich plasma (L-PRP', 'Twice centrifugation']","['abnormal blood samples (platelet recovery rate', 'leukocyte enrichment coefficient', 'platelet enrichment coefficient and platelet recovery rate', 'platelet recovery rate and platelet and leukocyte enrichment coefficient of L-PRP']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]",,0.0113833,The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05).,"[{'ForeName': 'Zhaoyuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': '.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201911054']
1754,32791704,"Evaluation of efficacy and safety of single and multiple therapy of herbal medicine/Chuna therapy on non-specific chronic low back pain: A study protocol for multicenter, 3-arm, randomized, single blinded, parallel group, incomplete factorial design, pilot study.","INTRODUCTION


Chronic non-specific low back pain is one of the common health issues which reduce the quality of life and in working population. While combined therapeutic treatment method is widely used for musculoskeletal related disorders in Korea, well-developed trials on the efficacy of single or combine therapy on herbal medicine and Chuna manual therapy (CMT) are scarce.
OBJECTIVE


This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang (SGHH) on work related chronic low back pain patients. The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone. The secondary aim is to examine the naïve direct comparison between SGHH and placebo.
METHOD


This trial is designed as a multicenter, randomized, controlled, clinical trial. A total of 150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center will be randomly assigned to 1 of 3 treatments with a ratio of 1:1:1. Eligible participant will be randomized to treatment arm A receive single treatment of Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy are administered concurrently, in treatment arm C, where individuals receive placebo with Chuna manual therapy. They will receive assigned treatment in 4 weeks and follow-up for 4 weeks. The primary endpoint is to assess the change in severity of low back pain from baseline. The secondary endpoints are the following: the changes in disability and health related quality of life. Adverse events will also be reported.
DISCUSSION


The study result will provide the valuable information for efficacy and safety of monotherapy and multiple therapy of herbal medicinal extract and Chuna manual therapy on chronic non-specific low back pain.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03132974.",2020,The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone.,"['non-specific chronic low back pain', 'chronic low back pain patients', '150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center']","['herbal medicine, Sogyeonghwalhyeol-tang (SGHH', 'placebo with Chuna manual therapy', 'herbal medicine/Chuna therapy', 'SGHH and placebo', 'Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy', 'herbal medicinal extract and Chuna manual therapy']","['change in severity of low back pain', 'disability and health related quality of life']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",150.0,0.222222,The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone.,"[{'ForeName': 'Youme', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'aDepartment of Science in Korean Medicine, Graduate School, Kyung Hee University, Seoul bDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Dae-Jeon University, Daejeon cDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Semyung University, Jecheon dDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Woosuk University, Jecheon eJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul fJaseng Hospital of Korean Medicine, Seoul gDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon University, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Bo-Hyoung', 'Initials': 'BH', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Min-Seok', 'Initials': 'MS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Sun Joong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yeon-Seok', 'Initials': 'YS', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Me-Riong', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yun-Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Seong-Gyu', 'Initials': 'SG', 'LastName': 'Ko', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021260']
1755,32791711,Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia.,"BACKGROUND


Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint may be an alternative approach. However, the efficacy and mechanism of rMS at HT7 acupoint for chronic insomnia has not been confirmed.
METHODS/DESIGN


This is a 3-armed randomized positive-controlled noninferiority clinical trial. We will allocate 45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1. Patients in the experimental group will be treated with rMS at HT7 acupoint while the others in the control group will be treated with rTMS at r-DLPFC or waiting treatment. All will be given rMS at HT7 or rTMS at r-DLPFC or no treatment for 10 days, and then received 20-day follow-up. Patients will be evaluated with the insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores for the cognition state before and the 10th day of treatment, 30th day of follow-up; study on mechanisms of rMS will be revealed through the resting motor threshold diversity of the motor cortex before and the 10th day of treatment, 30th day of follow-up. Baseline characteristics of patients will be summarized by groups and compared with Chi-squared for categorical variables, and analysis of variance or Kruskal-Wallis test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal-Wallis test.
CONCLUSION


The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia. With this research, we are looking forward to find out an appropriate alternative and easy therapy for chronic insomnia individuals compared with rTMS at r-DLPFC.
TRIAL REGISTRATION


The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR1900026844 on October 24, 2019.",2020,"The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia.","['45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1', 'patients with chronic insomnia']","['rMS at HT7 acupoint', 'Repetitive transcranial magnetic stimulation (rTMS', 'repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint', 'rMS at HT7 acupoint therapy', 'rTMS at r-DLPFC or waiting treatment', 'HT7 acupoint', 'low frequency repetitive magnetic stimulation at Shenmen (HT7']","['univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal-Wallis test', 'chronic insomnia', 'insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores', 'sleep quality']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450571', 'cui_str': 'HT7'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4274492', 'cui_str': 'Beck Anxiety Inventory score'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",45.0,0.0701115,"The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""aSchool of Basic Medical Sciences, Chengdu University of Traditional Chinese Medicine, Chengdu bDepartment of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine cSyndrome and Treatment Research Office For Insomnia With Yin Yang Sequential Treatment, Shaanxi Administration of Traditional Chinese Medicine dDepartment of Geriatrics, Xi'an Hospital of Traditional Chinese Medicine, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ''}, {'ForeName': 'Zhaoxin', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Zucheng', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Dongling', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021292']
1756,32792358,Tumor copy-number alterations predict response to immune-checkpoint-blockade in gastrointestinal cancer.,"BACKGROUND


Despite the great achievements made in immune-checkpoint-blockade (ICB) in cancer therapy, there are no effective predictive biomarkers in gastrointestinal (GI) cancer.
METHODS


This study included 93 metastatic GI patients treated with ICBs. The first cohort comprising 73 GI cancer patients were randomly assigned into discovery (n=44) and validation (n=29) cohorts. Comprehensive genomic profiling was performed on all samples to determine tumor mutational burden (TMB) and copy-number alterations (CNAs). A subset of samples was collected for RNA immune oncology (IO) panel sequencing, microsatellite instability (MSI)/mismatch repair and program death ligand 1 (PD-L1) expression evaluation. In addition, 20 gastric cancer (GC) patients were recruited as the second validation cohort.
RESULTS


In the first cohort of 73 GI cancer patients, a lower burden of CNA was observed in patients with durable clinical benefit (DCB). In both the discovery (n=44) and validation (n=29) subsets, lower burden of CNA was associated with an improved clinical benefit and better overall survival (OS). Efficacy also correlated with a higher TMB. Of note, a combinatorial biomarker of TMB and CNA may better stratify DCB patients from ICB treatment, which was further confirmed in the second validation cohort of 20 GC patients. Finally, patients with lower burden of CNA revealed increased immune signatures in our cohort and The Cancer Genome Atlas data sets as well.
CONCLUSIONS


Our results suggest that the burden of CNA may have superior predictive value compared with other signatures, including PD-L1, MSI and TMB. The joint biomarker of CNA burden and TMB may better stratify DCB patients, thereby providing a rational choice for GI patients treated with ICBs.",2020,Efficacy also correlated with a higher TMB.,"['20 gastric cancer (GC) patients were recruited as the second validation cohort', '93 metastatic GI patients treated with', '73\u2009GI cancer patients', 'gastrointestinal cancer']",['ICBs'],"['Efficacy', 'clinical benefit and better overall survival (OS', 'tumor mutational burden (TMB) and copy-number alterations (CNAs', 'burden of CNA']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}]",93.0,0.124652,Efficacy also correlated with a higher TMB.,"[{'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jifang', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Huaibo', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhenghang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Henghui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000374']
1757,32792359,Prediction of immune checkpoint inhibition with immune oncology-related gene expression in gastrointestinal cancer using a machine learning classifier.,"Immune checkpoint inhibitors (ICIs) have revolutionized the therapeutic landscape of gastrointestinal cancer. However, biomarkers correlated with the efficacy of ICIs in gastrointestinal cancer are still lacking. In this study, we performed 395-plex immune oncology (IO)-related gene target sequencing in tumor samples from 96 patients with metastatic gastrointestinal cancer patients treated with ICIs, and a linear support vector machine learning strategy was applied to construct a predictive model. ResultsAll 96 patients were randomly assigned into the discovery (n=72) and validation (n=24) cohorts. A 24-gene RNA signature (termed the IO-score) was constructed from 395 immune-related gene expression profiling using a machine learning strategy to identify patients who might benefit from ICIs. The durable clinical benefit rate was higher in patients with a high IO-score than in patients with a low IO-score (discovery cohort: 92.0% vs 4.3%, p<0.001; validation cohort: 85.7% vs 17.6%, p=0.004). The IO-score may exhibit a higher predictive value in the discovery (area under the receiver operating characteristic curve (AUC)=0.97)) and validation (AUC=0.74) cohorts compared with the programmed death ligand 1 positivity (AUC=0.52), tumor mutational burden (AUC=0.69) and microsatellite instability status (AUC=0.59) in the combined cohort. Moreover, patients with a high IO-score also exhibited a prolonged overall survival compared with patients with a low IO-score (discovery cohort: HR, 0.29; 95% CI 0.15 to 0.56; p=0.003; validation cohort: HR, 0.32; 95% CI 0.10 to 1.05; p=0.04). Taken together, our results indicated the potential of IO-score as a biomarker for immunotherapy in patients with gastrointestinal cancers.",2020,The durable clinical benefit rate was higher in patients with a high IO-score than in patients with a low IO-score (discovery cohort:,"['96 patients with metastatic gastrointestinal cancer patients treated with', 'ResultsAll 96 patients were randomly assigned into the discovery (n=72) and validation (n=24) cohorts', 'patients with gastrointestinal cancers', 'patients with a high IO-score than in patients with a low IO-score (discovery cohort']","['395-plex immune oncology (IO)-related gene target sequencing', 'Immune checkpoint inhibitors (ICIs', 'ICIs, and a linear support vector machine learning strategy']","['durable clinical benefit rate', 'potential of IO-score', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242613', 'cui_str': 'Gene Targeting'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",96.0,0.0635341,The durable clinical benefit rate was higher in patients with a high IO-score than in patients with a low IO-score (discovery cohort:,"[{'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Genecast Precision Medicine Technology Institute, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jifang', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Qi', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhenghang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Henghui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China shenlin@bjmu.edu.cn zhhbao@ccmu.edu.cn.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000631']
1758,32792449,Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial.,"INTRODUCTION


Temporomandibular disorders (TMDs) are considered a collection of musculoskeletal conditions involving the masticatory muscles, the temporomandibular joint and associated structures. The myogenous group appears to represent the most frequently diagnosed category. In the context of a multimodal approach, splint therapy and musculoskeletal physiotherapy are often considered as a preferred therapy. The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
METHODS AND ANALYSIS


All consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible. Inclusion criteria shall be based on the presence of myogenous TMDs, as diagnosed through clinical examination in reference to the international diagnostic criteria of TMDs. Randomisation, concealed allocation, blinded assessment and intention-to-treat analysis will be employed. The splint therapy will consist of the use of the splint every night and concurrent delivery of an educational programme; the protocol shall have a duration of three consecutive months. The combined musculoskeletal physiotherapy, splint therapy and education will additionally consist of manual therapy techniques and exercise; such protocol shall consist of a duration of three consecutive months, inclusive of 10 sessions for the enhanced elements. All outcome measures will be collected at baseline, after treatment and at a 6 months follow-up.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Independent Ethic Committee in Clinical Research of AUSL Bologna-Italy (47/2018/SPER/AUSLBO). Pursuant to applicable rules,we will obtain informed consent from each participant and collect data anonymously to maintain privacy. Results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences.
TRIAL REGISTRATION NUMBER


NCT03726060.",2020,"The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
","['myogenic temporomandibular disorders', 'All consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible']","['musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone', 'occlusal splint', 'physical therapy']",['pain and mandibular range of motion'],"[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",,0.0617932,"The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Incorvati', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy cristina.incorvati@unibo.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Romeo', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Fabrizi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Defila', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Vanti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Maria Rosaria Antonella', 'Initials': 'MRA', 'LastName': 'Gatto', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences(DIBINEM) Medical Statistics, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Marchetti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pillastrini', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-038438']
1759,32792454,"TASCI-transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial.","INTRODUCTION


Neurogenic lower urinary tract dysfunction (NLUTD), including neurogenic detrusor overactivity (NDO) and detrusor sphincter dyssynergia, is one of the most frequent and devastating sequelae of spinal cord injury (SCI), as it can lead to urinary incontinence and secondary damage such as renal failure. Transcutaneous tibial nerve stimulation (TTNS) is a promising, non-invasive neuromodulatory intervention that may prevent the emergence of the C-fibre evoked bladder reflexes that are thought to cause NDO. This paper presents the protocol for TTNS in acute SCI (TASCI), which will evaluate the efficacy of TTNS in preventing NDO. Furthermore, TASCI will provide insight into the mechanisms underlying TTNS, and the course of NLUTD development after SCI.
METHODS AND ANALYSIS


TASCI is a nationwide, randomised, sham-controlled, double-blind clinical trial, conducted at all four SCI centres in Switzerland. The longitudinal design includes a baseline assessment period 5-39 days after acute SCI and follow-up assessments occurring 3, 6 and 12 months after SCI. A planned 114 participants will be randomised into verum or sham TTNS groups (1:1 ratio), stratified on study centre and lower extremity motor score. TTNS is performed for 30 min/day, 5 days/week, for 6-9 weeks starting within 40 days after SCI. The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation. Secondary outcome measures assess bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue. Safety of TTNS is the tertiary outcome.
ETHICS AND DISSEMINATION


TASCI is approved by the Swiss Ethics Committee for Northwest/Central Switzerland, the Swiss Ethics Committee Vaud and the Swiss Ethics Committee Zürich (#2019-00074). Findings will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03965299.",2020,"The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation.","['A planned 114 participants', 'patients with acute spinal cord injury to prevent neurogenic detrusor overactivity']","['TASCI-transcutaneous tibial nerve stimulation', 'Transcutaneous tibial nerve stimulation (TTNS', 'TTNS', 'verum or sham TTNS']","['occurrence of NDO jeopardising the upper urinary tract at 1\u2009year after SCI, assessed by urodynamic investigation', 'bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue']","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0341736', 'cui_str': 'Neurogenic detrusor overactivity'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0341736', 'cui_str': 'Neurogenic detrusor overactivity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",114.0,0.485529,"The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation.","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Birkhäuser', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Collene E', 'Initials': 'CE', 'LastName': 'Anderson', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Inc., Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baumberger', 'Affiliation': 'Spinal Cord and Rehabilitation Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Birder', 'Affiliation': 'Neuro-Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Botter', 'Affiliation': 'Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland.'}, {'ForeName': 'Silvan', 'Initials': 'S', 'LastName': 'Büeler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Célia D', 'Initials': 'CD', 'LastName': 'Cruz', 'Affiliation': 'Instituto de Investigação e Inovação em Saúde, Translational Neuro-urology Group, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'David', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Freund', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Friedl', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Margret', 'Initials': 'M', 'LastName': 'Hund-Georgiadis', 'Affiliation': 'Clinic of Neurorehabilitation and Paraplegiology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Husmann', 'Affiliation': 'Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jordan', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koschorke', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Luca', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Möhr', 'Affiliation': 'Clinic of Neurorehabilitation and Paraplegiology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Freschta', 'Initials': 'F', 'LastName': 'Mohammadzada', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Monastyrskaya', 'Affiliation': 'Urology Research Laboratory, DBMR, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Pfender', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Sadri', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Sartori', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sprengel', 'Affiliation': 'Department of Trauma, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Stalder', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jivko', 'Initials': 'J', 'LastName': 'Stoyanov', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Stress', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Tatu', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tawadros', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wöllner', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Zubler', 'Affiliation': 'Department of Radiology, Balgrist University Hospital, Zürich, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Curt', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Pannek', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Martin W G', 'Initials': 'MWG', 'LastName': 'Brinkhof', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland tkessler@gmx.ch.'}]",BMJ open,['10.1136/bmjopen-2020-039164']
1760,32792467,"Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Doubleblind, Active-controlled Study.","Background/Aims


Prokinetics such as mosapride citrate (Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day DWJ1252, a sustained-release formulation of Gasmotin, compared with Gasmotin 3 times a day, in patients with FD.
Methods


In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for DWJ1252 and 59 for Gasmotin) were randomly allocated to DWJ1252 once daily or Gasmotin thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed.
Results


The study included 51 and 49 subjects in the test and control groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: -10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively;  P  < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81;  P  = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion


In patients with FD, DWJ1252 once daily is as effective as Gasmotin thrice daily, with a similar safety profile.",2020,"GIS scores at week 4 were significantly reduced in both groups (-10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively; p<0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; p=0.643).","['51 and 49 subjects in the test and control groups, respectively', '119 patients with FD (by the Rome III criteria, 60 for DWJ1252 and 59 for Gasmotin ® ', 'functional dyspepsia', 'patients with FD']","['Gasmotin®', 'DWJ1252', 'Gasmotin ®', 'DWJ1252 once daily or Gasmotin ®', 'mosapride citrate (Gasmotin ® ']","['GIS scores', 'Adverse events', 'Efficacy and safety', 'GIS changes', 'efficacy and safety', 'Changes in GIS', 'change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0245956', 'cui_str': 'mosapride citrate'}]","[{'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",119.0,0.385485,"GIS scores at week 4 were significantly reduced in both groups (-10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively; p<0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; p=0.643).","[{'ForeName': 'Jin Hwa', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kang Nyeong', 'Initials': 'KN', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Oh Young', 'Initials': 'OY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Gyu', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunsoo', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Suck-Chei', 'Initials': 'SC', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University Gangnam Hospital, Seoul, Korea.'}, {'ForeName': 'In-Kyung', 'Initials': 'IK', 'LastName': 'Sung', 'Affiliation': 'Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chong Il', 'Initials': 'CI', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sam Ryong', 'Initials': 'SR', 'LastName': 'Jee', 'Affiliation': 'Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Kyunghee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Poong-Lyul', 'Initials': 'PL', 'LastName': 'Rhee', 'Affiliation': 'Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Moo In', 'Initials': 'MI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Joong Goo', 'Initials': 'JG', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyung Sik', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Kwang Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology, Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea.'}, {'ForeName': 'Joon Seong', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20061']
1761,32804308,Improving cognitive mapping by training for people with a poor sense of direction.,"The skill of spatial learning and orientation is fundamental in humans and differs widely among individuals. Despite its importance, however, the malleability of this skill through practice has scarcely been studied empirically, in contrast to psychometric spatial ability. Thus, this article examines the possibility of improving the accuracy of configurational understanding of the environment by training. A total of 40 adults with a poor sense of direction participated in the experiment; and were randomly assigned to either a condition in which they received feedback only or a condition in which they additionally practiced allocentric spatial updating. Participants walked one route in each session, once a week for 6 weeks, and conducted spatial tasks designed to assess their knowledge of the route. A total of 20 people with an average sense of direction also participated as a comparison group. Results showed that training in allocentric spatial updating improved the accuracy of direction estimates, although the size of the effect was limited: the improvement was not large enough to equate the performance in the groups with a poor versus average sense of direction. The two groups, however, did not differ in spatial skill in mental rotation or path integration. Feedback was effective for improving accuracy in straight-line distance estimates and sketch maps: repeated trials with feedback led to improved accuracy by the sixth session to a level comparable to the group with an average sense of direction. The results show that flexible translation between viewer-centered and environment-centered representations is difficult and not readily trainable, and provide insights into the nature of individual differences in large-scale environmental cognition.",2020,Feedback was effective for improving accuracy in straight-line distance estimates and sketch maps: repeated trials with feedback led to improved accuracy by the sixth session to a level comparable to the group with an average sense of direction.,"['20 people with an\xa0average sense of direction also participated as a comparison group', '40 adults with a poor sense of direction participated in the experiment', 'people with a poor sense of direction']",['feedback only or a condition in which they additionally practiced allocentric spatial updating'],"['accuracy of direction estimates', 'spatial skill in mental rotation or path integration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0522247', 'cui_str': 'Sense of direction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",40.0,0.0181052,Feedback was effective for improving accuracy in straight-line distance estimates and sketch maps: repeated trials with feedback led to improved accuracy by the sixth session to a level comparable to the group with an average sense of direction.,"[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'University of Tokyo, Tokyo, Japan. toru.ishikawa@iniad.org.'}, {'ForeName': 'Yiren', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'University of Tokyo, Tokyo, Japan.'}]",Cognitive research: principles and implications,['10.1186/s41235-020-00238-1']
1762,32804388,Intubation using the gum-elastic bougie while wearing personal protective equipment.,"OBJECTIVE


To determine whether application of a gum-elastic bougie (GEB), a visual stylet used to improve success rates of difficult intubations, reduces the time, and number of attempts to achieve successful intubation while wearing personal protective equipment (PPE).
DESIGN


A randomized cross-over study comparing orotracheal intubations performed on an AirMan® Mannequin, using either a semirigid stylet or a GEB, while wearing an active hood with a charcoal impregnated suit and butyl rubber gloves.
SETTING


Simulation training field of the Israel Defense Force Medical Corps.
PARTICIPANTS


27 military physicians and 23 paramedics (PMs).
INTERVENTIONS


Comparing intubation with and without using the GEB while wearing PPE.
MAIN OUTCOME MEASURE(S)


Airway (AW) control was considered successful if the ""lungs"" of the mannequin ex-panded during bag ventilation. Three unsuccessful attempts or a procedure exceeding 60 seconds were regarded as a failure. Correlations between parameters of self-assessment of skills and successful intubation were also determined.
RESULTS


With the GEB, success rate was lower (82 percent versus 100 percent, p = 0.002), more attempts were needed (1.4 ± 0.7 versus 1.0 ± 0.2, p = 0.005) and time-to-achieve AW control was longer (43.6 ± 14.6 sec-onds versus 23.1 ± 10.5 seconds, P < 0.001) than without it. Participants with high self-assessment of GEB-assisted AW management skills needed less attempts to perform successful intubation with GEB than participants with low self-assessment (1.0 ± 0.0 versus 1.4 ± 0.8, p = 0.001), but not less time to achieve it.
CONCLUSIONS


While donning PPE, the use of GEB (versus semirigid stylets) did not reduce the time or the number of attempts necessary to achieve successful intubation.",2020,"Participants with high self-assessment of GEB-assisted AW management skills needed less attempts to perform successful intubation with GEB than participants with low self-assessment (1.0 ± 0.0 versus 1.4 ± 0.8, p = 0.001), but not less time to achieve it.
",['27 military physicians and 23 paramedics (PMs'],"['semirigid stylet or a GEB, while wearing an active hood with a charcoal impregnated suit and butyl rubber gloves', 'gum-elastic bougie while wearing personal protective equipment', 'GEB', 'orotracheal intubations', 'gum-elastic bougie (GEB']","['time-to-achieve AW control', 'success rate']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}]","[{'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C1742512', 'cui_str': 'Gum elastic bougie'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0054283', 'cui_str': 'butyl rubber'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}]",,0.0333568,"Participants with high self-assessment of GEB-assisted AW management skills needed less attempts to perform successful intubation with GEB than participants with low self-assessment (1.0 ± 0.0 versus 1.4 ± 0.8, p = 0.001), but not less time to achieve it.
","[{'ForeName': 'Nadav', 'Initials': 'N', 'LastName': 'Milk', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}, {'ForeName': 'Yossi', 'Initials': 'Y', 'LastName': 'Rosman', 'Affiliation': 'Unit of Allergy and Clinical Immunology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Nirit', 'Initials': 'N', 'LastName': 'Yavnai', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Division of Anesthesia, Intensive Care, and Pain Management, Tel-Aviv Medical Center, Tel-Aviv University, Tel-Aviv, Israel; Outcomes Research Consortium, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Nimrod', 'Initials': 'N', 'LastName': 'Ophir', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}, {'ForeName': 'Arik', 'Initials': 'A', 'LastName': 'Eisenkraft', 'Affiliation': 'Professor, Faculty of Medicine, Institute for Research in Military Medicine, The Hebrew University of Jeru-salem, Jerusalem, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kassirer', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}]",American journal of disaster medicine,['10.5055/ajdm.2020.0358']
1763,32801102,"Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results.","The relationships between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life (HRQoL) may be important for determining the overall impact of medication therapy on patients with epilepsy. The objectives of these post hoc analyses of the global Phase III 093-0304 trial (NCT00988429, Study 304) of adjunctive eslicarbazepine acetate (ESL) in patients with refractory focal (partial-onset) seizures (FS) were to evaluate associations between seizure severity change, measured by the Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS). The analyses were conducted on the per-protocol population (PPP) of patients who were randomized to a placebo arm (n = 188) or an ESL-active group that included treatment with adjunctive ESL 800 mg once daily (QD; n = 184) or adjunctive ESL 1200 mg QD (n = 175). General linear models (GLM) were used to measure the association between SSQ change and patient baseline characteristics or percentage change in the SSF from baseline. Associations between changes in the SSQ and changes in the QOLIE-31 and MADRS were examined using GLM with patient baseline characteristics as covariates. Subgroup analyses were performed for patients in the ESL-active group and those treated with ESL 800 mg or ESL 1200 mg. Minimal clinically important difference (MCIDs) thresholds were used to assess improvements in SSQ scores. The analyses included 547 per-protocol patients. Patients using 1 antiepileptic drug (AED) at baseline had greater improvements in the SSQ compared with those receiving 2 AEDs (P = 0.0606). Treatment with ESL 1200 mg was significantly associated with clinically meaningful improvements in the SSQ (P = 0.0005). The SSQ improvements were significantly associated with an SSF reduction of ≥75%, compared with no reduction (P < 0.0001). In the PPP and the ESL-active group, SSQ improvements were significantly associated with improvements in QOLIE-31 Total Score (TS; P < 0.0001) and the Seizure Worry (SW; P < 0.0001) and Social Functioning (SF; P = 0.0030) subscales. In the ESL 1200 mg subgroup, SSQ improvements were significantly associated with improvements in QOLIE-31 TS (P < 0.0001) and the SW (P < 0.0001) and Energy/Fatigue (EF; P = 0.0007) subscales. In the ESL 800 mg subgroup, improvements in the SSQ were significantly associated with improvements in QOLIE-31 TS (P = 0.0362) and the SW (P = 0.0241) subscale. There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL. These findings demonstrated that in this clinical trial population, adding ESL to baseline AED therapy had utility for decreasing seizure severity and improving HRQoL. There were no significant associations between changes in seizure severity and changes in depressive symptoms in patients with FS.",2020,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"['patients with refractory focal (partial-onset) seizures (FS', 'patients with epilepsy', 'patients with focal seizures treated with']","['adjunctive eslicarbazepine acetate', 'adjunctive eslicarbazepine acetate (ESL', 'adjunctive ESL 1200\u202fmg QD', 'ESL-active group that included treatment with adjunctive ESL 800', 'ESL 800\u202fmg or ESL', 'ESL', 'placebo']","['SSF reduction', 'SSQ scores', 'seizure frequency, and health-related quality of life (HRQoL', 'seizure frequency, and health-related quality of life', 'SSQ', 'QOLIE-31 Total Score', 'Seizure Worry', 'QOLIE-31 and MADRS', 'QOLIE-31 TS', 'seizure severity and improving HRQoL', 'Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social Functioning', 'seizure severity and changes in depressive symptoms', 'Energy/Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.147528,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"[{'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Cramer', 'Affiliation': 'Yale University School of Medicine and Consultant, Houston, TX 77027, United States of America. Electronic address: joyce.cramer@gmail.com.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Inc., Suite 3.02, Level 3, Building A, 97 Waterloo Road, Macquarie Corporate Centre, Macquarie Park, New South Wales 2113, Australia. Electronic address: Sam.Colman@covance.com.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Anastassopoulos', 'Affiliation': 'Covance Inc., 9801 Washingtonian Blvd., 9th. Floor, Gaithersburg, MD 20878, United States of America. Electronic address: kathryn.anastassopoulos@covance.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Darshan.Mehta@sunovion.com.'}, {'ForeName': 'G Rhys', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Gwilym.Williams@sunovion.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107312']
1764,32791321,Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial.,"The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy. We propose a theoretically-based approach that incorporates expression of the self-conscious emotion of guilt and the written analogue of change talk as proposed mechanisms of intervention efficacy. We will also examine individual differences in guilt-proneness as a moderator of intervention efficacy. Heavy drinking college students (N = 600) will be randomly assigned to one of six expressive writing conditions based on a 2 (alcohol vs. distress) × 2 (guilt vs. no guilt) + 1 (control writing) + 1 (personalized feedback) design. Participation in the study involves completion of a screening assessment, a baseline assessment, three in-lab intervention sessions, post-intervention assessments, and follow-up assessments one-month, three-months, six months, and twelve-months later. If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.",2020,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","['College students', 'Heavy drinking college students (N\u202f=\u202f600', 'college students']","['\u202f1 (control writing', 'Guilt and expressive writing', 'six expressive writing conditions based on a 2 (alcohol vs. distress']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",[],600.0,0.018722,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jordanna Lembo', 'Initials': 'JL', 'LastName': 'Riggs', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, NJ, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Angosta', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America. Electronic address: jangosta@central.uh.edu.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Cunningham-Erdogdu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Psychology, University of Texas at Austin, Austin, TX, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106107']
1765,32791322,The Aging PLUS  trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults.,"BACKGROUND


Negative views of aging (NVOA), low self-efficacy beliefs, and poor goal planning skills represent risk factors that undermine adults' motivation to engage in physical activity (PA). Targeting these three risk factors may motivate adults to become physically active.
OBJECTIVE


To assess the efficacy of Aging PLUS , a 4-week educational program that explicitly targets NVOA, low self-efficacy beliefs, and poor goal planning skills compared to a 4-week health education program. The study also examines the role of NVOA, self-efficacy beliefs, and goal planning as the mechanisms underlying change in PA.
DESIGN


This randomized controlled trial (RCT) utilizes the experimental medicine approach to assess change in PA as a function of modifying three risk factors. The RCT recruitment target includes 288 mostly sedentary adults ranging in age from 45 to 75 years.
METHODS


Eligible middle-aged and older adults are recruited through community sources. Participants are randomized to either the Aging PLUS  or the control group. Participants in both groups are enrolled in the trial for 8 months total, with four assessment points: Baseline (pre-test), Week 4 (immediate post-test), Week 8 (delayed post-test), and Month 6 (long-term follow-up). The intervention takes place over 4 consecutive weeks with 2-h sessions each week. PA engagement is the primary outcome variable. Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
SUMMARY


By utilizing a multi-component approach and targeting a cluster of psychological mechanisms, the Aging PLUS  program implements the experimental medicine approach to health behavior change.",2020,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","['middle-aged and older adults', '288 mostly sedentary adults ranging in age from 45 to 75\u202fyears', 'Eligible middle-aged and older adults']",[],"['physical activity', 'Positive changes in NVOA, self-efficacy beliefs']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",288.0,0.0622321,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Diehl', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States. Electronic address: manfred.diehl@colostate.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Nehrkorn-Bailey', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kaigang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bland', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Skylar', 'Initials': 'S', 'LastName': 'Feltner', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Forsyth', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hulett', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Berkeley', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Mars', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Martinez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mast', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Monasterio', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'Schoenberg', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomson', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Tseng', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106105']
1766,32791393,A Prospective Randomized Control Study Comparing the Effects of Dermal Staples and Intradermal Sutures on Postoperative Scarring After Thyroidectomy.,"BACKGROUND


We compared cosmetic outcomes, pain intensity, and costs between dermal stapling and intradermal suturing in patients who underwent thyroidectomy through cervical incision.
PATIENTS AND METHODS


In total, 40 patients were randomly assigned to undergo thyroidectomy through a low cervical incision and dermal closure using either absorbable staples (n = 20, staple group) or interrupted intradermal sutures (n = 20, suture group). Wound complications, cosmetic outcomes (modified Stony Brook Scar Evaluation Scale [SBSES] and Manchester Scar Scale [MSS]), and pain intensity (visual analog scale) were assessed at 1, 4, 12, and 24 weeks postoperatively. The difference in total ""wound-closure cost"" between the two groups was also analyzed.
RESULTS


There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively). However, the staple group had significantly higher SBSES scores, compared to the suture group, at 24 wk postoperatively (4.06 ± 0.94 versus 3.26 ± 1.24; P = 0.030, respectively); MSS scores were significantly lower in the staple group than in the suture group at 24 wk postoperatively (6.72 ± 1.27 versus 8.16 ± 2.17, respectively; P = 0.028). Visual analog scale scores were significantly lower in the suture group than in the staple group (P = 0.038). The total wound-closure cost was significantly higher in the staple group than in the suture group (137.10 ± 8.39 versus 81.79 ± 19.95 USD; P < 0.001).
CONCLUSIONS


When dermal staples were used, wound complications were absent and long-term cosmetic outcomes were superior; however, pain intensity was higher and the cost was greater, although healing was significantly more rapid, compared to intradermal sutures. Closure using absorbable dermal staples may be safe and effective for cervical incisions during thyroid surgery. Further studies with larger number of participants are needed to confirm our findings.",2020,"There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively).","['patients who underwent thyroidectomy through cervical incision', '40 patients']","['thyroidectomy through a low cervical incision and dermal closure using either absorbable staples (n\xa0=\xa020, staple group) or interrupted intradermal sutures', 'Dermal Staples and Intradermal Sutures', 'dermal stapling and intradermal suturing']","['Postoperative Scarring', 'total wound-closure cost', 'total ""wound-closure cost', 'healing', 'pain intensity', 'MSS scores', 'wound complications', 'Wound complications, cosmetic outcomes (modified Stony Brook Scar Evaluation Scale [SBSES] and Manchester Scar Scale [MSS]), and pain intensity (visual analog scale', 'pain intensity, and costs', 'SBSES or MSS scores', 'Visual analog scale scores', 'SBSES scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0442944', 'cui_str': 'Incision of neck'}]","[{'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442944', 'cui_str': 'Incision of neck'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}]","[{'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024814', 'cui_str': 'Marinesco-Sjögren syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",40.0,0.0378732,"There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively).","[{'ForeName': 'Dohoe', 'Initials': 'D', 'LastName': 'Ku', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Koo', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Dong Sik', 'Initials': 'DS', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea. Electronic address: md.ds.bae@gmail.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.06.052']
1767,32791434,Factors associated with readiness to quit smoking among young adults enrolled in a Facebook-based tobacco and alcohol intervention study.,"INTRODUCTION


Young adults who smoke cigarettes often report heavy episodic drinking (HED) and co-use of other psychoactive substances which may complicate efforts to quit cigarette smoking. The current study examined factors associated with readiness to quit cigarette smoking among young adults who smoke and engage in HED.
METHODS


One hundred seventy-nine young adults aged 18 to 25 who reported regular cigarette smoking and past month HED enrolled in the 90-day Facebook-based Smoking Tobacco and Drinking (STAND) intervention study. Analyses compared baseline differences in patterns of cigarette smoking and alcohol and cannabis use, thoughts about abstinence, use of nicotine replacement therapy (NRT), sociodemographic characteristics, and other health behaviors between participants who were ready to quit cigarette smoking in the next 30 days and those who were not.
RESULTS


Participants were 40.2% female, 49.7% male, 10.1% non-binary, and 80.4% Non-Hispanic White. They reported on average moderate nicotine dependence (FTCD), moderate risk for alcohol use disorder (AUDIT), and occasional or regular cannabis use. Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
CONCLUSIONS


Findings indicate that readiness to quit cigarette smoking among young adults who drink is positively associated with importance to reduce alcohol use, but not with use patterns or levels of dependence. Interventions addressing polysubstance use may be better suited to help young adults reduce or quit cigarette smoking once they signal readiness for behavior change.",2020,"Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
","['One hundred seventy-nine young adults aged 18 to 25 who reported regular cigarette smoking and past month HED enrolled in the 90-day Facebook-based Smoking Tobacco and Drinking (STAND) intervention study', 'young adults who smoke and engage in HED', 'young adults enrolled in a Facebook-based tobacco and alcohol intervention study', 'Young adults who smoke cigarettes often report heavy episodic drinking (HED', 'Participants were 40.2% female, 49.7% male, 10.1% non-binary, and 80.4% Non-Hispanic White']",[],"['Readiness to quit cigarette smoking', 'cigarette smoking and alcohol and cannabis use, thoughts about abstinence, use of nicotine replacement therapy (NRT), sociodemographic characteristics, and other health behaviors']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",179.0,0.016447,"Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
","[{'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States; Early Postdoc. Mobility Grantee (P2ZHP1_174812), Swiss National Science Foundation, Bern, Switzerland. Electronic address: larissa.maier@ucsf.edu.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: Danielle.Ramo@ucsf.edu.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: manpreetkaurkh@gmail.com.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: meredith.meacham@ucsf.edu.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States; Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States. Electronic address: derek.satre@ucsf.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106524']
1768,32792425,"Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric controlled, open, cluster-randomised, parallel-group study protocol.","INTRODUCTION


Fever is one of the most common reasons for consultation in the paediatric emergency department (ED). Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment. The aims of this study are to demonstrate that using a procalcitonin (PCT) rapid test-based prediction rule (1) would not be inferior to usual practice in terms of morbidity and mortality (non-inferiority objective) and (2) would result in a significant reduction in antibiotic use (superiority objective).
METHODS AND ANALYSIS


This prospective multicentric cluster-randomised study aims to include 7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period. During first period, all children will receive usual care. In a second period, a point-of-care PCT-based algorithm will be used in half of the clusters. The primary endpoints collected on day 15 after ED consultation will be a composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment administered for the superiority objective. The endpoints will be compared between the two groups (experimental and control) by using a mixed logistic regression model adjusted on clustering of participants within centres and period within centres.
DISCUSSION


If the algorithm is validated, a new strategy will be discussed with medical societies to safely manage fever in young children without the need for invasive procedures for microbiological testing or empirical antibiotics.
ETHICS AND DISSEMINATION


This study was submitted to an independent ethics committee on 17 May 2018 (no. 2018-A00252-53). Results will be submitted to international peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT03607162; Pre-results.",2020,"Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment.","['young febrile children in the emergency department (DIAFEVERCHILD', '7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period', 'young children', 'independent ethics committee on 17 May 2018 (no. 2018-A00252-53']",[],"['composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",7245.0,0.218545,"Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment.","[{'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Hubert', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France gaelle.hubert@chu-nantes.fr.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Launay', 'Affiliation': 'General Paediatrics Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Feildel Fournial', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chauvire-Drouard', 'Affiliation': 'Clinical Research Department, Clinical Investigation Center Femme Enfant Adolescent-1413 INSERM, CHU Nantes, Nantes, France.'}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Lorton', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': 'Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France.'}, {'ForeName': 'Christele', 'Initials': 'C', 'LastName': 'Gras Le Guen', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}]",BMJ open,['10.1136/bmjopen-2019-034828']
1769,32792427,Microwave ablation versus radiofrequency ablation for the treatment of severe complicated monochorionic pregnancies in China：protocol for a pilot randomised controlled trial.,"INTRODUCTION


Complicated monochorionic twin pregnancies are often associated with high perinatal morbidity and mortality, some of which are severe enough to require a gestational reduction surgery to improve fetal survival and reduce disabilities. While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions. Currently there is limited evidence to prove the feasibility of MWA for selective reduction. The aim of this pilot study is to explore the feasibility, efficacy and safety of MWA reduction for severe complicated monochorionic pregnancies and may provide evidence for using the MWA in intrauterine surgeries extensively.
METHODS AND ANALYSIS


This is a study protocol for a parallel-design pilot randomised controlled trial. 60 eligible patients with severe complicated monochorionic pregnancies will be randomised in a ratio of 1:1 to MWA group and radiofrequency group. Patients will be followed up until 6 months of age of the retained fetal. The primary analysis will compare the rates of neonatal survival at 28 days to evaluate the effect of MWA. The study will also evaluate the safety profile of MWA including the occurrence of postoperative adverse events and maternal and fetal complications. Additional secondary outcomes to be explored include the condition of neonatal asphyxia and the growth of surviving fetus at 6 months. Outcomes will be analysed by both a frequentist and the Bayesian statistical approach.
ETHICS AND DISSEMINATION


This study was approved by the ethical review committee of the Peking University Third Hospital (Beijing, China). The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences.
TRIAL REGISTRATION NUMBER


NCT04014452; Pre-results.",2020,"While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions.","['Peking University Third Hospital (Beijing, China', '60 eligible patients with severe complicated monochorionic pregnancies', 'severe complicated monochorionic pregnancies']","['Microwave ablation versus radiofrequency ablation', 'radiofrequency ablation', 'MWA', 'MWA group and radiofrequency group']","['condition of neonatal asphyxia and the growth of surviving fetus at 6 months', 'rates of neonatal survival']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",60.0,0.194793,"While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions.","[{'ForeName': 'Jialei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Tianchen', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China xlwang@bjmu.edu.cn weiyuanbysy@163.com.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China xlwang@bjmu.edu.cn weiyuanbysy@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034995']
1770,32792431,Impact of incremental versus conventional initiation of haemodialysis on residual kidney function: study protocol for a multicentre feasibility randomised controlled trial.,"INTRODUCTION


Preserving residual kidney function (RKF) may be beneficial to patients on haemodialysis (HD) and it has been proposed that commencing dialysis incrementally rather than three times a week may preserve RKF. In Incremental HD, target dose includes a contribution from RKF, which is added to HD dose, allowing individualisation of the HD prescription. We will conduct a feasibility randomised controlled trial (RCT) comparing incremental HD and conventional three times weekly treatments in incident HD patients. The study is designed also to provide pilot data to allow determination of effect size to power a definitive study.
METHODS AND ANALYSIS


After screening to ensure native renal urea clearance >3 mL/min/1.73 m 2 , the study will randomise 54 patients within 3 months of HD initiation to conventional in-centre thrice weekly dialysis or incremental in-centre HD commencing 2 days a week. Subjects will be followed up for 12 months. The study will be carried out across four UK renal centres.The primary outcome is to evaluate the feasibility of conducting a definitive RCT and to estimate the difference in rate of decline of RKF between the two groups at 6 and 12 months time points. Secondary outcomes will include the impact of dialysis intensity on vascular access events, major adverse cardiac events and survival. Impact of dialysis intensity on patient-reported outcomes measures, cognition and frailty will be assessed using EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score. Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.This study will inform the design of a definitive study, adequately powered to determine whether RKF is better preserved after incremental HD initiation compared with conventional initiation.
ETHICS AND DISSEMINATION


Ethics approval has been granted by Cambridge South Research Ethics Committee, United Kingdom(REC17/EE/0311). Results will be disseminated via peer-reviewed publication.
TRIAL REGISTRATION NUMBER


NCT03418181.",2020,"Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.","['incident HD patients', 'four UK renal centres']","['RKF', 'incremental versus conventional initiation of haemodialysis']","['impact of dialysis intensity on vascular access events, major adverse cardiac events and survival', 'feasibility of conducting a definitive RCT', 'hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events', 'EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score', 'residual kidney function', 'rate of decline of RKF']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",54.0,0.192481,"Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.","[{'ForeName': 'Raja Mohammed', 'Initials': 'RM', 'LastName': 'Kaja Kamal', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Farrington', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wellsted', 'Affiliation': 'School of Life Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK.'}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Sridharan', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Alchi', 'Affiliation': 'Renal Unit, Royal Berkshire NHS Foundation Trust, Reading, Berkshire, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': 'Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, Leicestershire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'Renal Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Vilar', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK enric.vilar@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2019-035919']
1771,32792446,"The GALANT trial: study protocol of a randomised placebo-controlled trial in patients with a  68   Ga  -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of  lan  reotide on  t  umour size.","INTRODUCTION


At present, there is no approved medical treatment option for patients with non-functioning pituitary adenoma. A number of open-label studies suggest that treatment with somatostatin analogues may prevent tumour progression. In vivo somatostatin receptor imaging using  68 Ga-DOTATATE PET (PET, positron emission tomography) could help in preselecting patients potentially responsive to treatment. Our aim is to investigate the effect of the somatostatin analogue lanreotide as compared with placebo on tumour size in patients with a  68 Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA).
METHODS AND ANALYSIS


The GALANT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients with a suprasellar extending NFMA. Included patients undergo a  68 Ga-DOTATATE PET/CT of the head and tracer uptake is assessed after coregistration with pituitary MRI. Forty-four patients with a  68 Ga-DOTATATE PET-positive NFMA are randomised in a 1:1 ratio between lanreotide 120 mg or placebo, both administered as subcutaneous injections every 28 days for 72 weeks. The primary outcome is the change in cranio-caudal tumour diameter on pituitary MRI after treatment. Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events. Final results are expected in the second half of 2021.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Medical Research Ethics Committee of the Academic Medical Centre (AMC) of the Amsterdam University Medical Centres and by the Dutch competent authority. It is an investigator-initiated study with financial support by Ipsen Farmaceutica BV. The AMC, as sponsor, remains owner of all data. Results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NL5136 (Netherlands Trial Register); pre-recruitment.",2020,"Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events.","['patients with a  68 Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA', 'Forty-four patients with a  68 Ga-DOTATATE PET-positive NFMA', 'patients with a  68   Ga  -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of  lan  reotide on  t  umour size', 'patients with non-functioning pituitary adenoma', 'adult patients with a suprasellar extending NFMA']","['somatostatin analogue lanreotide', 'lanreotide 120 mg or placebo', 'placebo']","['change in cranio-caudal tumour diameter on pituitary MRI', 'change in tumour volume, time to tumour progression, change in quality of life and number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C4256789', 'cui_str': 'dotatate'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0346308', 'cui_str': 'Pituitary macroadenoma'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0338078', 'cui_str': 'Functionless pituitary adenoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0230054', 'cui_str': 'Structure of suprasellar region'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0732165', 'cui_str': 'Somatostatin analog'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.570073,"Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events.","[{'ForeName': 'Tessel M', 'Initials': 'TM', 'LastName': 'Boertien', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands t.m.boertien@amsterdamumc.nl.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Drent', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Booij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel P M', 'Initials': 'MPM', 'LastName': 'Stokkel', 'Affiliation': 'Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jantien', 'Initials': 'J', 'LastName': 'Hoogmoed', 'Affiliation': 'Department of Neurosurgery, Neurosurgical Centre Amsterdam, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pereira', 'Affiliation': 'Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Nienke R', 'Initials': 'NR', 'LastName': 'Biermasz', 'Affiliation': 'Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Simsek', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Groote Veldman', 'Affiliation': 'Department of Internal Medicine, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Michael W T', 'Initials': 'MWT', 'LastName': 'Tanck', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fliers', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bisschop', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-038250']
1772,32796392,Adjunctive Raloxifene and Isradipine Improve Cognitive Functioning in Patients With Schizophrenia: A Pilot Study.,"BACKGROUND


Cognitive impairment is the most important feature of schizophrenia leading to severe functional disability. To identify pathways that improve pathophysiological neurocognition in schizophrenia is a current challenge for the development of goal-directed clinical interventions. In the present study, we investigated the effects of raloxifene (a selective estrogen modulator) and isradipine (a voltage-gated L-type calcium channel blocker) on cognitive deficits in patients with schizophrenia.
METHOD


We designed a double-blind, randomized, parallel, placebo-controlled trial. We randomized 60 patients with schizophrenia into 3 groups including isradipine 5 mg, raloxifine 60 mg, and placebo for 6 consequent weeks, all in the same shape capsules, 2 times a day, along with treatment as usual. The initial and final results of blood tests, electrocardiograms, and cognitive tests in specific domains, such as attention, processing speed, executive function, and verbal memory were evaluated.
RESULTS


Our findings revealed a remarkable association between adjunctive raloxifene treatment and the alleviation of verbal memory deficits. Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo. However, no effect was observed in processing speed and executive function deficits.
CONCLUSIONS


To the best of our knowledge, this study provides the first evidence that isradipine is a novel therapy option improving verbal memory and attention, both related to its activity in the hippocampus and the cerebellum. Further investigations are necessary to elucidate the mechanisms of action for both drugs in schizophrenia.",2020,"Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo.","['Patients With Schizophrenia', '60 patients with schizophrenia into 3 groups including', 'patients with schizophrenia']","['Isradipine', 'Adjunctive Raloxifene and Isradipine', 'isradipine', 'isradipine (a voltage-gated L-type calcium channel blocker', 'isradipine 5 mg, raloxifine 60 mg, and placebo', 'raloxifene', 'placebo']","['blood tests, electrocardiograms, and cognitive tests in specific domains, such as attention, processing speed, executive function, and verbal memory', 'Cognitive Functioning', 'verbal memory and attention dysfunction', 'alleviation of verbal memory deficits', 'processing speed and executive function deficits', 'cognitive deficits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0288263', 'cui_str': 'L-Type Calcium Channels'}, {'cui': 'C0987008', 'cui_str': 'Isradipine 5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",60.0,0.0752954,"Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo.","[{'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Vahdani', 'Affiliation': 'From the Department of Psychiatry, Bahamn Hospital, Qazvin University of Medical Sciences, Qazvin.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Armani Kian', 'Affiliation': 'Department of Psychiatry, Beheshti Hospital.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Department of Immunology.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Zenoozian', 'Affiliation': 'Department of Clinical Psychology, Beheshti Hospital.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Yousefi', 'Affiliation': 'Department of Clinical Psychology, Beheshti Hospital.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Mazloomzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001274']
1773,32796391,Anti-inflammatory Combination Therapy for the Treatment of Schizophrenia.,"BACKGROUND


Despite adequate antipsychotic treatment, most people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. The current study was designed to examine the efficacy and safety of adjunctive anti-inflammatory combination therapy for these illness manifestations.
METHODS


Thirty-nine people with either Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, schizophrenia or schizoaffective disorder were entered into a 12-week double-blind, 2-arm, triple-dummy, placebo-controlled, randomized clinical trial: 19 were randomized to anti-inflammatory combination therapy and 20 were randomized to placebo. The Brief Psychiatric Rating Scale positive symptom item total score was used to assess positive symptom change, the Scale for the Assessment of Negative Symptoms total score was used to assess negative symptom change, the Calgary Depression Scale total score was used to assess depressive symptom change, and the MATRICS Consensus Cognitive Battery was used to assess neuropsychological test performance.
RESULTS


There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant. There were no significant time (t144 = 0.53, P = 0.72), treatment (t58=0.48, P = 0.63), or treatment × time (t143 = -0.20, P = 0.84) effects for the Scale for the Assessment of Negative Symptoms total score; or for any of the other symptom measures. There were no significant group differences in the change in the MATRICS Consensus Cognitive Battery composite score over the course of the study (F1,26=2.20, P = 0.15).
CONCLUSIONS


The study results suggest that there is no significant benefit of combined anti-inflammatory treatment for persistent positive symptoms or negative symptoms or cognitive impairments (clinicaltrials.gov trial number: NCT01514682).",2020,"There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant.","['Thirty-nine people with either Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, schizophrenia or schizoaffective disorder']","['adjunctive anti-inflammatory combination therapy', 'anti-inflammatory combination therapy', 'placebo']","['Brief Psychiatric Rating Scale positive symptom item score', 'Consensus Cognitive Battery composite score', 'negative symptom change, the Calgary Depression Scale total score', 'Brief Psychiatric Rating Scale positive symptom item total score', 'efficacy and safety', 'neuropsychological test performance']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]",19.0,0.122251,"There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant.","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'From the Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zaranski', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Blatt', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wehring', 'Affiliation': ''}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Carpenter', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001253']
1774,32360744,Maternal-fetal disposition of domoic acid following repeated oral dosing during pregnancy in nonhuman primate.,"Domoic acid (DA) is a marine algal toxin that causes acute and chronic neurotoxicity in animals and humans. Prenatal exposure to DA has been associated with neuronal damage and cognitive and behavioral deficits in juvenile California sea lions, cynomolgus monkeys and rodents. Yet, the toxicokinetics (TK) of DA during pregnancy and the maternal-fetal disposition of DA have not been fully elucidated. In this study, we investigated the TK before, during, and after pregnancy and the maternal-fetal disposition of DA in 22 cynomolgus monkeys following daily oral doses of 0.075 or 0.15 mg/kg/day of DA. The AUC 0-τ  of DA was not changed while the renal clearance of DA was increased by 30-90% during and after pregnancy when compared to the pre-pregnancy values. DA was detected in the infant plasma and in the amniotic fluid at delivery. The infant plasma concentrations correlated positively with both the maternal plasma and the amniotic fluid concentrations. The paired infant-to-maternal plasma DA concentration ratios ranged from 0.3 to 0.6 and increased as a function of time which suggests placental efflux and longer apparent fetal half-life than the maternal half-life. The paired amniotic fluid-to-infant plasma DA concentration ratios ranged from 4.5 to 7.5 which indicates significant accumulation of DA in the amniotic fluid. A maternal-fetal TK model was developed to explore the processes that give the observed maternal-fetal disposition of DA. The final model suggests that placental transport and recirculation of DA between the fetus and amniotic fluid are major determining factors of the maternal-fetal TK of DA.",2020,The AUC 0-τ  of DA was not changed while the renal clearance of DA was increased by 30-90% during and after pregnancy when compared to the pre-pregnancy values.,[],['Domoic acid (DA'],"['paired infant-to-maternal plasma DA concentration ratios', 'renal clearance of DA', 'paired amniotic fluid-to-infant plasma DA concentration ratios', 'infant plasma concentrations']",[],"[{'cui': 'C0058678', 'cui_str': 'Amnesic shellfish poison'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0058678', 'cui_str': 'Amnesic shellfish poison'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}]",,0.0275756,The AUC 0-τ  of DA was not changed while the renal clearance of DA was increased by 30-90% during and after pregnancy when compared to the pre-pregnancy values.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shum', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Petroff', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crouthamel', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Grant', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA; Infant Primate Research Laboratory, Washington National Primate Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Burbacher', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA; Center on Human Development and Disability, University of Washington, Seattle, Washington, USA; Infant Primate Research Laboratory, Washington National Primate Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Isoherranen', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, USA; Center on Human Development and Disability, University of Washington, Seattle, Washington, USA. Electronic address: ni2@uw.edu.'}]",Toxicology and applied pharmacology,['10.1016/j.taap.2020.115027']
1775,32795086,"Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58.","BACKGROUND


Patients with peripheral artery disease (PAD) are at heightened risk of cardiovascular complications. The sodium-glucose cotransporter 2 inhibitor dapagliflozin reduces the risk for hospitalization for heart failure (HHF) and kidney events in patients with type 2 diabetes mellitus. An increased risk of amputation has been observed with canagliflozin in 1 previous trial. We examined cardiovascular and kidney efficacy and the risk of limb-related events in patients with and without PAD in an exploratory analysis.
METHODS


A total of 17 160 patients with type 2 diabetes mellitus, including 1025 (6%) with PAD, were randomized. Key efficacy outcomes were MACE (cardiovascular [CV] death, myocardial infarction, stroke), CV death/HHF, and progression of kidney disease. Amputations, peripheral revascularization, and limb ischemic adverse events were site-reported and categorized by a blinded reviewer.
RESULTS


Patients in the placebo arm with PAD versus those without tended to have higher adjusted risk of CV death, myocardial infarction, or stroke (adjusted hazard ratio [HR], 1.23 [95% CI, 0.97-1.56],  P =0.094) and significantly higher adjusted risk of CV death/HHF (adjusted HR, 1.60 [95% CI, 1.21-2.12],  P =0.0010) and progression of kidney disease (adjusted HR, 1.51 [95% CI, 1.13 - 2.03],  P =0.0058), and limb adverse events (adjusted HR, 8.37,  P <0.001). The relative risk reductions with dapagliflozin for CV death/HHF (HR, 0.86, PAD; HR, 0.82, no-PAD;  P -interaction=0.79) and progression of kidney disease (HR, 0.78, PAD; HR, 0.76, no-PAD;  P -interaction=0.84) were consistent regardless of PAD. There were 560 patients who had at least 1 limb ischemic event, 454 patients with at least 1 peripheral revascularization, and 236 patients with at least 1 amputation, with a total of 407 amputations reported. Overall, there were no significant differences in any limb outcome with dapagliflozin versus placebo including limb ischemic adverse events (HR, 1.07 [95% CI, 0.90-1.26]) and amputation (HR, 1.09 [95% CI, 0.84-1.40]), with no significant interactions by a history of PAD versus not ( P -interactions=0.30 and 0.093, respectively).
CONCLUSIONS


Patients with versus without PAD are at a higher risk of CV death of CV death, HHF, and kidney outcomes, and have a consistent benefits for CV death/HHF and progression of kidney disease with dapagliflozin. Patients with PAD had a higher risk of limb events, with no consistent pattern of incremental risk observed with dapagliflozin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01730534.",2020,"Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  ","['17,160 patients with T2DM, including 1,025 (6%) with PAD', 'Patients', '560 patients who had at least one limb ischemic event, 454 patients with at least one peripheral revascularization, and 236 patients with at least one amputation with a total of 407 amputations reported', 'patients with and without peripheral artery disease (PAD) in an exploratory analysis', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with peripheral artery disease (PAD']","['SGLT2 inhibitor (SGLT2i) dapagliflozin', 'dapagliflozin vs. placebo', 'canagliflozin', 'placebo']","['Dapagliflozin and Cardiac, Kidney and Limb Outcomes', 'adjusted risk of CV Death/HHF', 'progression of kidney disease', 'MACE (CV Death, MI, stroke), CV Death/HHF, and progression of kidney disease', 'risk of MACE, CV Death/HHF and kidney outcomes', 'risk of limb events', 'Amputations, peripheral revascularization and limb ischemic adverse events', 'limb ischemic adverse events', 'adjusted risk of MACE', 'risk of amputation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",17160.0,0.184605,"Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  ","[{'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI (Thrombolysis in Myocardial Infarction) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA (M.P.B., S.D.W., T.A.Z., D.L.B., E.L.G., M.S.S.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI (Thrombolysis in Myocardial Infarction) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA (M.P.B., S.D.W., T.A.Z., D.L.B., E.L.G., M.S.S.).""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI (Thrombolysis in Myocardial Infarction) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA (M.P.B., S.D.W., T.A.Z., D.L.B., E.L.G., M.S.S.).""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Israel (O.M., A.C., I.R.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI (Thrombolysis in Myocardial Infarction) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA (M.P.B., S.D.W., T.A.Z., D.L.B., E.L.G., M.S.S.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Ontario, Canada (L.A.L.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI (Thrombolysis in Myocardial Infarction) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA (M.P.B., S.D.W., T.A.Z., D.L.B., E.L.G., M.S.S.).""}, {'ForeName': 'Remo Holanda', 'Initials': 'RH', 'LastName': 'De Mendonca Furtado', 'Affiliation': 'Hospital Albert Einstein and Instituto do Coracao da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil (R.H.D.M.F.).'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, United Kingdom (J.P.H.W.).'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Israel (O.M., A.C., I.R.).'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., P.J., M.F., P.A.J., A.M.L.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., P.J., M.F., P.A.J., A.M.L.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., P.J., M.F., P.A.J., A.M.L.).'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., P.J., M.F., P.A.J., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., P.J., M.F., P.A.J., A.M.L.).'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Israel (O.M., A.C., I.R.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI (Thrombolysis in Myocardial Infarction) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA (M.P.B., S.D.W., T.A.Z., D.L.B., E.L.G., M.S.S.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.044775']
1776,32803820,Short Message Service reminders reduce outpatient colonoscopy nonattendance rate: A randomized controlled study.,"BACKGROUND AND AIM


Nonattendance of outpatient colonoscopy leads to inefficient use of health-care resources. We aimed to study the effectiveness of using Short Message Service (SMS) reminder prior in patients scheduled for outpatient colonoscopy on their nonattendance rate.
METHODS


Patients who scheduled for an outpatient colonoscopy and had access of SMS were recruited from three clinics in Hong Kong. Patients were randomized to SMS group and standard care (SC) group. All patients were given a written appointment slip on the booking date. In addition, patients in the SMS group received an SMS reminder 7-10 days before their colonoscopy appointment. Patients' demographics, attendance, colonoscopy completion, and bowel preparation quality were recorded. Logistic regression was performed to identify predictors of nonattendance.
RESULTS


From November 2013 to October 2019, a total of 2225 eligible patients were recruited. A total of 1079 patients were allocated to the SMS group and 1146 to the SC group. The nonattendance rate of patients in the SMS group was significantly lower than that in the SC group (8.9% vs 11.9%, P = 0.022). There were no significant differences in their baseline characteristics and colonoscopy completion rate and bowel preparation quality. A trend towards a higher rate of adequate bowel preparation was observed in the SMS group when compared with the SC group (69.9% vs 65.8%, P = 0.053). Independent predictors for nonattendance included younger age, underprivilege, and existing diabetes.
CONCLUSIONS


An SMS reminder for outpatient colonoscopy is effective in reducing the nonattendance rate and may potentially improve the bowel preparation quality.",2020,There were no significant differences in their baseline characteristics and colonoscopy completion rate and bowel preparation quality.,"['patients scheduled for outpatient colonoscopy on their nonattendance rate', '1079 patients', 'From November 2013 to October 2019, a total of 2225 eligible patients were recruited', 'Patients who scheduled for an outpatient colonoscopy and had access of SMS were recruited from three clinics in Hong Kong']","['SMS', 'Short Message Service (SMS) reminder prior', 'Short Message Service (SMS) reminders', 'SMS group and standard care group (SC']","['nonattendance rate', 'colonoscopy completion rate and bowel preparation quality', 'rate of adequate bowel preparation', ""Patients' demographics, attendance, colonoscopy completion and bowel preparation quality""]","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",2225.0,0.111367,There were no significant differences in their baseline characteristics and colonoscopy completion rate and bowel preparation quality.,"[{'ForeName': 'Thomas Y T', 'Initials': 'TYT', 'LastName': 'Lam', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Aric J', 'Initials': 'AJ', 'LastName': 'Hui', 'Affiliation': 'Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sia', 'Affiliation': 'Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong.'}, {'ForeName': 'Mei Y', 'Initials': 'MY', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Casper C P', 'Initials': 'CCP', 'LastName': 'Lee', 'Affiliation': 'Wong Siu Ching Family Medicine Centre, Hong Kong.'}, {'ForeName': 'Ka W', 'Initials': 'KW', 'LastName': 'Chung', 'Affiliation': 'Wong Siu Ching Family Medicine Centre, Hong Kong.'}, {'ForeName': 'James Y W', 'Initials': 'JYW', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Peter I', 'Initials': 'PI', 'LastName': 'Wu', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Joseph J Y', 'Initials': 'JJY', 'LastName': 'Sung', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15218']
1777,32803113,Does the repeat dose of gonadotropin-releasing hormone agonist trigger in polycystic ovarian syndrome improve in vitro fertilization cycles outcome? A clinical trial study.,"Background


A repeat dose of Gonadotropin-releasing Hormone (GnRH) agonist could provide long duration of luteinizing hormone (LH) surge and amplitude appropriately.
Objective


Improvement in oocyte maturity could be obtained by a repeat dose of GnRH agonist.
Materials and Methods


In this randomized double-blinded study, 120 women with polycystic ovarian syndrome and serum estradiol level (E2)  >  3000 who were candidate for in vitro fertilization with Antagonist protocol were enrolled between July 2018 and July 2019. Participants were randomized in two groups - and final oocyte maturation was triggered with two doses: In group A, a repeat dose of 0.1 mg, 12 hr. after the first dose and in group B, 0.2 mg SC triptorelin (decapeptyl) 35 hr. prior to oocyte retrieval. Serum Estradiol, LH, and progesterone concentration were measured on the trigger day. Serum LH measurement was done three times in both groups. The outcomes were oocyte yield, meiosis (M) I, MII, Maturity rate, germinal vesicle (GV) rate, 2 pronuclear, embryo yield, ovarian hyper stimulation syndrome rates.
Results


Maturity rate (p = 0.89), MI (p = 0.38), MII (p = 0.89), and GV oocytes (p = 0.38) were not statistically different between the two study groups. LH levels measured at 12 hr post-trigger did not relate statistically significant with maturity rate in our participants (p = 0.96). No empty follicular syndrome was reported.
Conclusion


Although, the second dose of GnRH agonist after 12 hr since the first dose could provide duration of LH surge and amplitude and as a result no empty follicular syndrome was seen, the maturity rate, MI, MII, and GV oocytes were not different between the two study groups.",2020,"Results


Maturity rate (p = 0.89), MI (p = 0.38), MII (p = 0.89), and GV oocytes (p = 0.38) were not statistically different between the two study groups.",['120 women with polycystic ovarian syndrome and serum estradiol level (E2)  >  3000 who were candidate for in vitro fertilization with Antagonist protocol were enrolled between July 2018 and July 2019'],"['SC triptorelin', 'gonadotropin-releasing hormone agonist trigger', 'Gonadotropin-releasing Hormone (GnRH) agonist']","['oocyte yield, meiosis (M) I, MII, Maturity rate, germinal vesicle (GV) rate, 2 pronuclear, embryo yield, ovarian hyper stimulation syndrome rates', 'MI', 'luteinizing hormone (LH) surge', 'MII', 'maturity rate', 'Serum Estradiol, LH, and progesterone concentration', 'Maturity rate', 'GV oocytes', 'maturity rate, MI, MII, and GV oocytes', 'LH levels', 'Serum LH measurement']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0025186', 'cui_str': 'Meiosis'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0333262', 'cui_str': 'Vesicle'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441683', 'cui_str': 'Hormone measurement'}]",120.0,0.307118,"Results


Maturity rate (p = 0.89), MI (p = 0.38), MII (p = 0.89), and GV oocytes (p = 0.38) were not statistically different between the two study groups.","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Aflatoonian', 'Affiliation': 'Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haghighi', 'Affiliation': 'Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'Masrooreh', 'Initials': 'M', 'LastName': 'Hoseini', 'Affiliation': 'Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Haghdani', 'Affiliation': 'Department of Urology, Hasheminejad Kidney Research Center (HKRC), Iran University of Medical Science, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i7.7363']
1778,32791810,"[Phase Ⅲ randomized controlled, multicenter, prospective study of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer: the HOPES Study].","Objective:  To evaluate the clinical efficacy and safety of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer.  Methods:  Patients were randomized 2∶1 to test group and control group. Patients in test group received Cipterbin (4 mg/kg loading dose and 2 mg/kg maintenance dose each week, IV) combined with vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV). Patients in control group received vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV).The primary end point was progression free survival (PFS).  Results:  A total of 315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group). The median PFS of test group was significantly longer than that of control group, 39.1 weeks vs 14.0 weeks ( HR =0.24; 95 %CI , 0.16-0.36;  P< 0.000 1). The objective response rate (ORR) and disease control rate (DCR) in test group were significantly higher than those in control group, ORR was 46.7% vs 18.45% ( P< 0.000 1) and DCR was 79.72% vs 45.63% ( P< 0.000 1). The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.The most common adverse events associated with Cipterbin were infusion reactions. Left ventricular ejection fraction reduced to less than 50% in 5 patients, which were recovered. No serious cardiotoxicity.  Conclusion:  The recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine has significant efficacy and good safety. It is the optimized therapy regime for patients with taxane-pretreated HER2 positive metastatic breast cancer, which provides more targeted therapy opportunities for HER2 positive breast cancer patients in China.",2020,"The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.","['patients with taxane-pretreated HER2 positive metastatic breast cancer', 'HER2 positive breast cancer patients in China', 'patients with HER2 positive metastatic breast cancer', '315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group']","['recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine', 'vinorelbine', 'Cipterbin']","['progression free survival (PFS', 'incidence of neutropenia, leucopenia and erythrocytopenia', 'ORR', 'median PFS', 'Left ventricular ejection fraction', 'objective response rate (ORR) and disease control rate (DCR', 'DCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0221395', 'cui_str': 'Erythropenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]",315.0,0.0281007,"The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Xu', 'Affiliation': 'Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Di', 'Affiliation': 'Peking University Cancer Hospital & Institute, Beijing 100038, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou310000, China.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Jiao', 'Affiliation': 'The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Z S', 'Initials': 'ZS', 'LastName': 'Tong', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Fujian Cancer Hospital, Fuzhou 350011, China.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing 210009, China.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou 510080, China.'}, {'ForeName': 'Q T', 'Initials': 'QT', 'LastName': 'Yu', 'Affiliation': 'Guangxi Medical University Affiliated Cancer Hospital, Nanning 530021, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'The First Hospital of China Medical University, Shenyang110001, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Sunshine Guojian Pharmaceutical(Shanghai)Co., Ltd, Shanghai 200090, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 210002 China.'}, {'ForeName': 'Z F', 'Initials': 'ZF', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200116-00105']
1779,32795875,Cost-effectiveness analysis of the 70-gene signature compared with clinical assessment in breast cancer based on a randomised controlled trial.,"BACKGROUND


The clinical utility of the 70-gene signature (MammaPrint®) to guide chemotherapy use in T1-3N0-1M0 breast cancer was demonstrated in the Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (MINDACT) study. One thousand four ninety seven of 3356 (46.2%) enrolled patients with high clinical risk (in accordance with the modified Adjuvant! Online clinical-pathological assessment) had a low-risk 70-gene signature. Using patient-level data from the MINDACT trial, the cost-effectiveness of using the 70-gene signature to guide adjuvant chemotherapy selection for clinical high risk, estrogen receptor positive (ER+), human epidermal growth factor 2 negative (HER2-) patients was analysed.
PATIENTS AND METHODS


A hybrid decision tree-Markov model simulated treatment strategies in accordance with the 70-gene signature with clinical assessment versus clinical assessment alone, over a 10-year time horizon. Primary outcomes were quality-adjusted life years (QALYs), country-specific costs and incremental cost-effectiveness ratios (ICERs) for six countries: Belgium, France, Germany, Netherlands, UK and the US.
RESULTS


Treatment strategies guided by the 70-gene signature result in more QALYs compared with clinical assessment alone. Costs of the 70-gene signature strategy were lower in five of six countries. This led to dominance of the 70-gene signature in Belgium, France, Germany, Netherlands and the US and to a cost-effective situation in the UK (ICER £22,910/QALY). Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US). UK budget increase was £8.4M.
CONCLUSION


Using the 70-gene signature to safely guide chemotherapy de-escalation in clinical high risk patients with ER+/HER2- tumours is cost-effective compared with using clinical assessment alone. Long-term follow-up and outcomes from the MINDACT trial are necessary to address uncertainties in model inputs.",2020,"Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US).",['One thousand four ninety seven of 3356 (46.2%) enrolled patients with high clinical risk (in accordance with the modified Adjuvant'],[],"['quality-adjusted life years (QALYs), country-specific costs and incremental cost-effectiveness ratios (ICERs) for six countries: Belgium, France, Germany, Netherlands, UK and the US', 'Annual national cost savings']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]",[],"[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.0661509,"Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US).","[{'ForeName': 'Valesca P', 'Initials': 'VP', 'LastName': 'Retèl', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands. Electronic address: v.retel@nki.nl.'}, {'ForeName': 'Danalyn', 'Initials': 'D', 'LastName': 'Byng', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Linn', 'Affiliation': 'Division of Molecular Pathology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Department of Medical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Department of Pathology, University Medical Centre, Utrecht University, Huispost STR 6.131, P.O. Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Jóźwiak', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Institute of Biostatistics and Registry Research, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Koffijberg', 'Affiliation': 'Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}, {'ForeName': 'Emiel J', 'Initials': 'EJ', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal, Av. De Brasilia, s/n, 1400-048, Lisbon, Portugal.'}, {'ForeName': 'Martine J', 'Initials': 'MJ', 'LastName': 'Piccart', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.-C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles, 121-125, Boulevard de Waterloo, 1000, Brussels, Belgium.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Avenue Emmanuel Mounier, 83/11, 1200, Brussels, Belgium.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""Van't Veer"", 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, 2340 Sutter Street, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Harten', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.002']
1780,32795903,Ventilatory support during whole-body row training improves oxygen uptake efficiency in patients with high-level spinal cord injury: A pilot study.,"High-level spinal cord injury (SCI) is characterized by profound respiratory compromise. One consequence is a limitation of whole-body exercise-based rehabilitation, reducing its cardioprotective effect. We investigated the use of ventilatory support during training on cardiorespiratory response to exercise. Nine subjects with high-level SCI (T3-C4) were included in this double-blind sham-controlled study. All had training adaptations plateauing for more than 6 months before enrolling in the study. After performing baseline assessment, participants were randomly assigned to continue training with non-invasive ventilation (NIV: n = 6: IPAP = 20 ± 2, EPAP: 3 cmH 2 O) or sham (n = 3: IPAP = 5, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests. We compared the oxygen uptake efficiency slope (OUES, the rate of increases in VO 2  in relation to increasing VE) before and after training. Training with NIV increased OUES both compared to baseline (4.1 ± 1.1 vs. 3.4 ± 1.0, i.e. +20 ± 12%, p < 0.05) and Sham (p = 0.01), representing an increase in ability to uptake oxygen for a given ventilation. This result was sustained without NIV during the test, suggesting improved cardiopulmonary reserve. Best responders were the youngest whose characteristics were very similar to sham participants. In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham). Our results are very suggestive of a positive effect of ventilatory support during whole-body exercise in high-level SCI. Training adaptations found are of great importance since this sub-population of patients have the greatest need for exercise-based cardio-protection.",2020,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","['Nine subjects with high-level SCI (T3-C4', 'patients with high-level spinal cord injury']","['continue training with non-invasive ventilation (NIV: n\xa0=\xa06: IPAP\xa0=\xa020\xa0±\xa02, EPAP: 3 cmH 2 O) or sham (n\xa0=\xa03: IPAP\xa0=\xa05, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests', 'Ventilatory support during whole-body row training']","['oxygen uptake efficiency', 'weekly rowing distance', 'ability to uptake oxygen', 'oxygen uptake efficiency slope (OUES']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",9.0,0.0857854,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, 75013, Paris, France. Electronic address: isabelle.vivodtzev@sorbonne.universite.fr.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Napolitano', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106104']
1781,32804188,Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial.,"Importance


Morphine is used as palliative treatment of chronic breathlessness in patients with advanced chronic obstructive pulmonary disease (COPD). Evidence on respiratory adverse effects and health status is scarce and conflicting.
Objective


To assess the effects of regular, low-dose, oral sustained-release morphine on disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness in patients with COPD.
Interventions


Participants were randomly assigned to 10 mg of regular, oral sustained-release morphine or placebo twice daily for 4 weeks, with the possibility to increase to 3 times daily after 1 or 2 weeks.
Design, Setting, and Participants


The Morphine for Treatment of Dyspnea in Patients With COPD (MORDYC) study was a randomized, double-blind, and placebo-controlled study of a 4-week intervention. Patients were enrolled between November 1, 2016, and January 24, 2019. Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program. Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4) despite optimal pharmacological and nonpharmacological treatment were included. A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate.
Main Outcomes and Measures


Primary outcomes were CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2). Secondary outcome was breathlessness in the previous 24 hours (numeric rating scale). Data were analyzed by intention to treat. Subgroup analyses in participants with mMRC grades 3 to 4 were performed.
Results


A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54%]). Difference in CAT score was 2.18 points lower in the morphine group (95% CI, -4.14 to -0.22 points; P = .03). Difference in Paco2 was 1.19 mm Hg higher in the morphine group (95% CI, -2.70 to 5.07 mm Hg; P = .55). Breathlessness remained unchanged. Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03). Five participants of 54 in the morphine group (9%) and 1 participant of 57 in the placebo group (2%) withdrew because of adverse effects. No morphine-related hospital admissions or deaths occurred.
Conclusions and Relevance


In this randomized clinical trial, regular, low-dose, oral sustained-release morphine for 4 weeks improved disease-specific health status in patients with COPD without affecting Paco2 or causing serious adverse effects. The worst breathlessness improved in participants with mMRC grades 3 to 4. A larger randomized clinical trial with longer follow-up in patients with mMRC grades 3 to 4 is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02429050.",2020,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","['Patients With COPD (MORDYC', 'A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54', 'patients with COPD without affecting Paco2 or causing serious adverse effects', 'Patients were enrolled between November 1, 2016, and January 24, 2019', 'participants with mMRC grades 3 to 4 were performed', 'Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4', 'patients with COPD', 'A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate', 'patients with advanced chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease on Health Status', 'patients with mMRC grades 3 to 4 is warranted', 'Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program']","['regular, oral sustained-release morphine or placebo', 'morphine', 'oral sustained-release morphine', 'regular, low-dose, oral sustained-release morphine', 'Morphine', 'Sustained-Release Morphine', 'placebo']","['Worst breathlessness', 'adverse effects', 'CAT score', 'Breathlessness', 'Difference in Paco2', 'CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2', 'worst breathlessness', 'hospital admissions or deaths occurred', 'disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness', 'disease-specific health status', 'breathlessness in the previous 24 hours (numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1380.0,0.443493,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","[{'ForeName': 'Cornelia A', 'Initials': 'CA', 'LastName': 'Verberkt', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke H J', 'Initials': 'MHJ', 'LastName': 'van den Beuken-van Everdingen', 'Affiliation': 'Centre of Expertise for Palliative Care, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hameleers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research & Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.3134']
1782,32804205,Effect of High-Dose Erythropoietin on Blood Transfusions in Extremely Low Gestational Age Neonates: Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Extremely preterm infants are among the populations receiving the highest levels of transfusions. Erythropoietin has not been recommended for premature infants because most studies have not demonstrated a decrease in donor exposure.
Objectives


To determine whether high-dose erythropoietin given within 24 hours of birth through postmenstrual age of 32 completed weeks will decrease the need for blood transfusions.
Design, Setting, and Participants


The Preterm Erythropoietin Neuroprotection Trial (PENUT) is a randomized, double-masked clinical trial with participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States. Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days). Exclusion criteria included conditions known to affect neurodevelopmental outcomes. Of 3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to erythropoietin (n = 477) or placebo (n = 464). Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019.
Interventions


In this post hoc analysis, erythropoietin, 1000 U/kg, or placebo was given every 48 hours for 6 doses, followed by 400 U/kg or sham injections 3 times a week through postmenstrual age of 32 weeks.
Main Outcomes and Measures


Need for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level are presented herein.
Results


A total of 936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g. Erythropoietin treatment (vs placebo) decreased the number of transfusions (unadjusted mean [SD], 3.5 [4.0] vs 5.2 [4.4]), with a relative rate (RR) of 0.66 (95% CI, 0.59-0.75); the cumulative transfused volume (mean [SD], 47.6 [60.4] vs 76.3 [68.2] mL), with a mean difference of -25.7 (95% CI, 18.1-33.3) mL; and donor exposure (mean [SD], 1.6 [1.7] vs 2.4 [2.0]), with an RR of 0.67 (95% CI, 0.58-0.77). Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001). Of 936 infants, 160 (17.1%) remained transfusion free at the end of 12 postnatal weeks, including 43 in the placebo group and 117 in the erythropoietin group (P < .001).
Conclusions and Relevance


These findings suggest that high-dose erythropoietin as used in the PENUT protocol was effective in reducing transfusion needs in this population of extremely preterm infants.
Trial Registration


ClinicalTrials.gov Identifier: NCT01378273.",2020,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","['Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days', '936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g', '3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to', 'Extremely Low Gestational Age Neonates', 'participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States', 'Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019']","['Erythropoietin treatment (vs placebo', 'High-Dose Erythropoietin', 'erythropoietin', 'Erythropoietin', 'placebo']","['Measures\n\n\nNeed for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level', 'number of transfusions', 'Blood Transfusions', 'transfusion free', 'hematocrit levels', 'cumulative transfused volume']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1963096', 'cui_str': 'AE-941'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",936.0,0.764264,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Wadhawan', 'Affiliation': 'Department of Neonatal-Perinatal Medicine, AdventHealth, Orlando, Florida.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Arkansas, Little Rock.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Kaashif A', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': ""Department of Neonatal Medicine, Methodist Children's Hospital, San Antonio, Texas.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bendel-Stenzel', 'Affiliation': ""Department of Neonatology, Children's Minnesota, Minneapolis.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Baserga', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City.'}, {'ForeName': 'Edmund F', 'Initials': 'EF', 'LastName': 'LaGamma', 'Affiliation': ""Department of Neonatal Medicine, Maria Fareri Children's Hospital at Westchester, Valhalla, New York.""}, {'ForeName': 'L Corbin', 'Initials': 'LC', 'LastName': 'Downey', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Shea"", 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Fahim', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""Department of Neonatology, Children's Minnesota, St Paul.""}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Prentice Women's Hospital, Chicago, Illinois.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ohls', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of New Mexico, Albuquerque.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of the University of Illinois, Chicago.""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Perez', 'Affiliation': 'Department of Neonatology, South Miami Hospital, South Miami, Florida.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'McKay', 'Affiliation': ""Department of Neonatology, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.2271']
1783,32798834,The role of parental psychological flexibility in childhood asthma management: An analysis of cross-lagged panel models.,"OBJECTIVE


This is a secondary analysis of a previously reported randomized controlled trial, aimed at examining the mediating role of parental psychological flexibility (PF) in an Acceptance and Commitment Therapy (ACT)-based childhood asthma management program for parents.
METHODS


The participants were 168 parents (mean age (SD) = 38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD) = 6.81 (2.50) years; 62% boys). They were randomly allocated to either the program composed of a four-session, group-based ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group). The parents underwent assessments at baseline, and immediately, 3-months, and 6-months after the intervention for the following outcomes: PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21); and the asthma symptoms and use of inhaled bronchodilators of their children.
RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
CONCLUSION


ACT makes a unique contribution to improving the health outcomes of parents and their children diagnosed with asthma through fostering parental PF.",2020,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","['childhood asthma management', 'participants were 168 parents (mean age (SD)\u202f=\u202f38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD)\u202f=\u202f6.81 (2.50) years; 62% boys', 'parents', 'parents and their children diagnosed with asthma through fostering parental PF']","['ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group', 'ACT', 'parental psychological flexibility (PF', 'inhaled bronchodilators of their children']","['nighttime symptoms', 'childhood asthma symptoms', 'parental psychological distress', 'PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21']","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",168.0,0.118973,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","[{'ForeName': 'Yuen Yu', 'Initials': 'YY', 'LastName': 'Chong', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong. Electronic address: conniechong@cuhk.edu.hk.'}, {'ForeName': 'Yim Wah', 'Initials': 'YW', 'LastName': 'Mak', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Alice Yuen', 'Initials': 'AY', 'LastName': 'Loke', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110208']
1784,32798835,"Effects of food-related behavioral activation therapy on eating styles, diet quality and body weight change: Results from the MooDFOOD Randomized Clinical Trial.","OBJECTIVE


Depression and obesity are bi-directionally related, eating styles and diet quality are two important factors associated with both. It remains uncertain if and how these two factors can be modified. Therefore the current study aims to investigate whether food-related behavioral activation therapy (F-BA), targeting mood, dietary habits and food related behavior, can improve eating styles, and diet quality and reduce body weight in adults with overweight or obesity and subsyndromal depressive symptoms.
METHODS


Data were derived from the MooDFOOD prevention trial, a 2x2 factorial RCT investigating the effect of nutritional strategies on prevention of depression. Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight were analyzed among 1025 adults who either received F-BA or no intervention for 12 months. Intervention effect was tested by longitudinal analysis of covariance using mixed model analysis.
RESULTS


The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA. The effect of the F-BA therapy on emotional and uncontrolled eating was stronger in those with higher baseline depressive symptoms (IDS-SR). The F-BA did also lead to small improvements in MDS (β=1.95, p<.001), but not to change in body weight.
CONCLUSION


Our trial showed no reduction in bodyweight, but provides support for the possibility to improve both unhealthy eating styles and diet quality using an intervention targeting these specifically, although effects were small [Trial registration: clinicaltrials.gov NCT02529423].",2020,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","['adults with overweight or obesity and subsyndromal depressive symptoms', '1025 adults who either received']","['food-related behavioral activation therapy', 'F-BA therapy', 'F-BA or no intervention', 'food-related behavioral activation therapy (F-BA']","['Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight', 'uncontrolled eating', 'emotional and uncontrolled eating', 'eating styles, and diet quality and reduce body weight', 'cognitive restrained eating', 'emotional', 'eating styles, diet quality and body weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",1025.0,0.112594,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","[{'ForeName': 'Nadine P G', 'Initials': 'NPG', 'LastName': 'Paans', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands. Electronic address: n.paans@ggzingeest.nl.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatic and Psychotherapy, Senckenberg Distinguished Professorship, Goethe-University Frankfurt, Frankfurt A.M., Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Medical Faculty, Leipzig, Germany.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110206']
1785,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
1786,32798927,A randomized controlled trial of 25 sessions comparing music therapy and music listening for children with autism spectrum disorder.,"BACKGROUND


Music therapy is based on the use of musical elements by a trained and qualified therapist. Clinical researches have suggested that children with Autism Spectrum Disorders (ASD) may benefit from MT. In this regard, this study examines if MT is more effective than simply listening to music for children with ASD.
METHOD


A 8-month RCT has been carried out comparing music therapy (MT) to music listening (ML) for children with ASD aged from 4 to 7 years old. Thirty-seven participants were randomly assigned to one of the two groups (MT vs. ML). The outcome measures were the Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML).
RESULTS


CGI scores decreased more for participants in the MT than in the ML condition. This clinical improvement was associated with an improvement of autistic symptoms on lethargy and stereotypy ABC subscales.
CONCLUSION


Our findings suggest that music therapy is more efficient than music listening for children with ASD. The present study thus supports the consideration of MT as a rightful add-on to ASD healthcare programs.",2020,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","['children with ASD', 'children with ASD aged from 4 to 7 years old', 'children with autism spectrum disorder', 'Thirty-seven participants', 'children with Autism Spectrum Disorders (ASD']","['MT', 'music therapy', 'music therapy and music listening', 'music therapy (MT) to music listening (ML']","['autistic symptoms on lethargy and stereotypy ABC subscales', 'Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML', 'CGI scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.0933362,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rabeyron', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France. Electronic address: thomas.rabeyron@univ-lorraine.fr.'}, {'ForeName': 'Juan-Pablo', 'Initials': 'JP', 'LastName': 'Robledo Del Canto', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre for Music and Science, University of Cambridge, United Kingdom.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Carasco', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bisson', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bodeau', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Vrait', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': 'Université de Strasbourg, Hôpitaux Universitaires de Strasbourg, Inserm U1114, France; Collègue Universitaire des Médecines Intégratives et Complémentaires (CUMIC), Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonnot', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}]",Psychiatry research,['10.1016/j.psychres.2020.113377']
1787,32800792,Exercise intensity and cardiovascular health outcomes after 12 months of football fitness training in women treated for stage I-III breast cancer: Results from the football fitness After Breast Cancer (ABC) randomized controlled trial.,"PURPOSE


To examine the exercise intensity and impact of 12 months of twice-weekly recreational football training on cardiorespiratory fitness (CRF), blood pressure (BP), resting heart rate (HR rest ), body fat mass, blood lipids, inflammation, and health-related quality of life in women treated for early-stage breast cancer (BC).
METHODS


Sixty-eight women who had received surgery for stage I-III BC and completed adjuvant chemo- and/or radiation therapy within 5 years were randomized in a 2:1 ratio to a Football Fitness group (FFG, n = 46) or a control group (CON, n = 22). Football Fitness sessions comprised a warm-up, drills and 3-4 × 7 min of small-sided games (SSG). Assessments were performed at baseline, 6 months and 12 months. Outcomes were peak oxygen uptake (VO 2 peak), blood pressure (BP), HR rest , total body fat mass, and circulating plasma lipids and hs-CRP, and the 36-Item Short Form Health Survey (SF36). Intention-to-treat (ITT) analyses were performed using linear mixed models. Data are means with SD or 95% confidence intervals.
RESULTS


Adherence to training in participants completing the 12-months follow-up (n = 33) was 47.1% (22.7), and HR during SSG was ≥80% of HR max  for 69.8% (26.5) of total playing time. At baseline, VO 2 peak was 28.5 (6.4) and 25.6 (5.9) ml O 2 /kg/min in FFG and CON, respectively, and no significant changes were observed at 6- or 12 months follow-up. Systolic BP (SBP) was 117.1 (16.4) and 116.9 (14.8) mmHg, and diastolic BP (DBP) was 72.0 (11.2) and 72.4 (8.5) mmHg in FFG and CON, respectively, at baseline, and a 9.4 mmHg decrease in SBP in CON at 12 months resulted in a between-group difference at 12 months of 8.7 mmHg (p = .012). Blood lipids and hs-CRP were within the normal range at baseline, and there were no differences in changes between groups over the 12 months. Similarly, no differences between groups were observed in HR rest  and body fat mass at 6- and12-months follow-up. A between-group difference in mean changes of 23.5 (0.95-46.11) points in the role-physical domain of the SF36 survey favored FFG at 6 months.
CONCLUSION


Football Fitness training is an intense exercise form for women treated for breast cancer, and self-perceived health-related limitations on daily activities were improved after 6 months. However, 1 year of Football Fitness training comprising 1 weekly training session on average did not improve CRF, BP, blood lipids, fat mass, or HR rest .
TRIAL REGISTRATION NUMBER


The trial was registered at ClinicalTrials.gov with identifier NCT03284567.",2020,"Blood lipids and hs-CRP were within the normal range at baseline, and there were no differences in changes between groups over the 12 months.","['women treated for early-stage breast cancer (BC', 'women treated for stage I-III breast cancer', 'within 5\u202fyears', 'Sixty-eight women who had received surgery for stage I-III BC and completed adjuvant chemo']","['and/or radiation therapy', 'Football Fitness group (FFG, n\u202f=\u202f46) or a control group (CON', 'twice-weekly recreational football training', 'Football Fitness training', 'football fitness training']","['peak oxygen uptake (VO 2 peak), blood pressure (BP), HR rest , total body fat mass, and circulating plasma lipids and hs-CRP, and the 36-Item Short Form Health Survey (SF36', 'HR rest  and body fat mass', 'diastolic BP (DBP', 'Systolic BP (SBP', 'Exercise intensity and cardiovascular health outcomes', 'SBP in CON', 'CRF, BP, blood lipids, fat mass, or HR rest ', 'Blood lipids and hs-CRP', 'cardiorespiratory fitness (CRF), blood pressure (BP), resting heart rate (HR rest ), body fat mass, blood lipids, inflammation, and health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0016712', 'cui_str': ""Freund's adjuvant""}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",68.0,0.192289,"Blood lipids and hs-CRP were within the normal range at baseline, and there were no differences in changes between groups over the 12 months.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Uth', 'Affiliation': 'University Hospitals Centre for Health Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. Electronic address: jacob.baekmark.uth@regionh.dk.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Fristrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sørensen', 'Affiliation': 'University Hospitals Centre for Health Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Eva Wulff', 'Initials': 'EW', 'LastName': 'Helge', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maja Kjærgaard', 'Initials': 'MK', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julie Boye', 'Initials': 'JB', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Trine Kjeldgaard', 'Initials': 'TK', 'LastName': 'Møller', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Magni', 'Initials': 'M', 'LastName': 'Mohr', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Faculty of Health Sciences, University of the Faroe Islands, Tórshavn, Faroe Islands.'}, {'ForeName': 'Jørn Wulff', 'Initials': 'JW', 'LastName': 'Helge', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark; Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Eva Soelberg', 'Initials': 'ES', 'LastName': 'Vadstrup', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Sport and Health Sciences, Exeter University, United Kingdom; Shanghai University of Sport, China.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.08.002']
1788,32805594,Behavioral changes in preterm children during nasogastric tube feeding. Comparative study of manual administration by parents versus mechanical administration via electric syringe pump.,"INTRODUCTION


Manual feeding by parents using a syringe, a widespread practice in Sweden since the 1980s, favors parents' involvement in childcare tasks. This approach is used in our neonatal unity since 2007.
OBJECTIVE


To study the behavioral changes of preterm children during nasogastric tube feeding: manual milk administration by parents (MAP) versus electric syringe administration (ESA) over a 30-minute period.
METHOD


This is a randomized, crossover study conducted in the neonatology unit of Toulouse. Preterm children under 33 weeks of age and over 7 days of life were included. A video recording was performed to assess the children's behavioral response, using the Dsilna score. The reviewer was blinded.
RESULTS


15 preterm children with a median gestational age of 30.1 weeks and a median birth weight of 1.210 g were included from March to October 2012. The facility, environment, and state of alertness of children were similar in both groups. Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"". Although not significant, motor withdrawal signs were more apparent and fluctuating in the ESA group. Qualitative analysis of NIDCAP observations confirms this data.
CONCLUSION


There are behavior changes of preterm children during nasogastric tube feeding. This pilot study showed previously undescribed results: MAP is associated with more common well-being signs and could be more widely used in neonatal units.",2020,"Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"".","['15 preterm children with a median gestational age of 30.1\xa0weeks and a median birth weight of 1.210\xa0g were included from March to October 2012', 'preterm children during nasogastric tube feeding', 'Preterm children under 33\xa0weeks of age and over 7\xa0days of life were included', 'preterm children']","['nasogastric tube feeding: manual milk administration by parents (MAP) versus electric syringe administration (ESA', 'manual administration by parents versus mechanical administration via electric syringe pump', 'ESA']","['Behavioral changes', 'motor withdrawal signs', 'facility, environment, and state of alertness of children']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric feeding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0192456', 'cui_str': 'Nasogastric feeding'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0181332', 'cui_str': 'Syringe pump'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C4304523', 'cui_str': 'Withdrawal sign'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",15.0,0.0633833,"Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"".","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Angot', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France. Electronic address: angot-florent@laposte.net.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Van Vooren', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Castex', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France; Nursery Hospital, Nîme, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Glorieux', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Casper', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France; Department of Neonatology, University Hospital, Doha, Qatar.'}]",Early human development,['10.1016/j.earlhumdev.2020.105151']
1789,32805700,"The effect of circadian-adjusted LED-based lighting on sleep, daytime sleepiness and biomarkers of inflammation in a randomized controlled cross-over trial by pragmatic design in elderly care home dwellers.","AIM


Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities. The project aimed to study the possible effect of indoor circadian-adjusted LED-lighting (CaLED) in the elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation.
METHODS


A 16-week trial study was performed to follow the intervention and control groups using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation.
RESULTS


There was no significant impact on sleep improvement after the short intervention time when analyzing the PSQI and ESS results. However, we found several challenges using these tools for this specific group of individuals. Thus, important knowledge was gained for future studies in elderly care home dwellers. The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention. This study represents a first-to-date attempt to ameliorate the adverse effects of sleep disturbances that characterize a randomly chosen group of elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment.
CONCLUSION


In this pragmatic randomized study of home dwelling individuals we were not able to demonstrate an improved sleep pattern as judged by PSQI, ESS or a change in inflammatory state.",2020,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"['elderly care home dwellers', ""elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation"", 'elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment', 'Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities', 'home dwelling individuals']","['indoor circadian-adjusted LED-lighting (CaLED', 'circadian-adjusted LED-based lighting']","['sleep improvement', 'inflammation state', 'sleep, daytime sleepiness and biomarkers of inflammation', 'Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0167666,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"[{'ForeName': 'Christine Borgen', 'Initials': 'CB', 'LastName': 'Linander', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: christine.borgen.linander@regionh.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: thomas.kallemose@regionh.dk.'}, {'ForeName': 'Lillian Moerch', 'Initials': 'LM', 'LastName': 'Joergensen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: lillian.moerch.joergensen@regionh.dk.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: ove.andersen@regionh.dk.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Nehlin', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: jan.nehlin@regionh.dk.'}, {'ForeName': 'Baker Nawfal', 'Initials': 'BN', 'LastName': 'Jawad', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: baker.jawad@regionh.dk.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104223']
1790,32807209,A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial.,"BACKGROUND


Azithromycin is an orally active synthetic macrolide antibiotic with a wide range of anti-bacterial, anti-inflammatory and antiviral properties. It is a safe, inexpensive, generic licenced drug available worldwide and manufactured to scale and is a potential candidate therapy for pandemic coronavirus disease 2019 (COVID-19). Azithromycin was widely used to treat severe SARS-CoV and MERS-CoV, but to date, no randomised data are available in any coronavirus infections. Other ongoing trials are exploring short courses of azithromycin either in early disease, within the first 7 days of symptoms, when azithromycin's antiviral properties may be important, or late in disease when anti-bacterial properties may reduce the risk of secondary bacterial infection. However, the molecule's anti-inflammatory properties, including suppression of pulmonary macrophage-derived pro-inflammatory cytokines such as interleukins-1β, -6, -8, and -18 and cytokines G-CSF and GM-CSF may provide a distinct therapeutic benefit if given in as a prolonged course during the period of progression from moderate to severe disease.
METHODS


ATOMIC2 is a phase II/III, multi-centre, prospective, open-label, two-arm randomised superiority clinical trial of azithromycin versus standard care for adults presenting to hospital with COVID-19 symptoms who are not admitted at initial presentation. We will enrol adults, ≥ 18 years of age assessed in acute hospitals in the UK with clinical diagnosis of COVID-19 infection where management on an ambulatory care pathway is deemed appropriate. Participants will be randomised in a 1:1 ratio to usual care or to azithromycin 500 mg orally daily for 14 days with telephone follow-up at days 14 and 28. The primary objective is to compare the proportion with either death or respiratory failure requiring invasive or non-invasive mechanical ventilation over 28 days from randomisation. Secondary objectives include mortality/respiratory failure in those with a PCR-confirmed diagnosis; all-cause mortality; progression to pneumonia; progression to severe pneumonia; peak severity of illness and mechanistic analysis of blood and nasal biomarkers.
DISCUSSION


This trial will determine the clinical utility of azithromycin in patients with moderately severe, clinically diagnosed COVID-19 and could be rapidly applicable worldwide.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04381962 . Registered on 11 May 2020. EudraCT identifier 2020-001740-26 . Opened for accrual on 29 May 2020.",2020,"It is a safe, inexpensive, generic licenced drug available worldwide and manufactured to scale and is a potential candidate therapy for pandemic coronavirus disease 2019 (COVID-19).","['adults presenting to hospital with COVID-19 symptoms who are not admitted at initial presentation', 'enrol adults, ≥\u200918\u2009years of age assessed in acute hospitals in the UK with clinical diagnosis of COVID-19 infection where management on an ambulatory care pathway is deemed appropriate', 'ambulatory COVID-19', 'patients with moderately severe']","['azithromycin', 'Azithromycin', 'invasive or non-invasive mechanical ventilation']","['proportion with either death or respiratory failure', 'mortality/respiratory failure in those with a PCR-confirmed diagnosis; all-cause mortality; progression to pneumonia; progression to severe pneumonia; peak severity of illness and mechanistic analysis of blood and nasal biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449976', 'cui_str': 'Initial presentation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.197629,"It is a safe, inexpensive, generic licenced drug available worldwide and manufactured to scale and is a potential candidate therapy for pandemic coronavirus disease 2019 (COVID-19).","[{'ForeName': 'Timothy S C', 'Initials': 'TSC', 'LastName': 'Hinks', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK. timothy.hinks@ndm.ox.ac.uk.'}, {'ForeName': 'Vicki S', 'Initials': 'VS', 'LastName': 'Barber', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maisha', 'Initials': 'M', 'LastName': 'Jabeen', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Melhorn', 'Affiliation': 'University Hospital Llandough, Cardiff, CF64 2XX, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lasserson', 'Affiliation': 'Nuffield Department of Medicine, Oxford University, Oxford, UK.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bafadhel', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}]",Trials,['10.1186/s13063-020-04593-8']
1791,32810055,"Effects of Teaching Evidence-Based Medicine on Physician Assistant Students' Critical Appraisal, Self-Efficacy, and Clinical Application: A Randomized Controlled Trial.","PURPOSE


To use a randomized controlled design to explore the effects of evidence-based medicine (EBM) education on physician assistant (PA) students' EBM knowledge, self-efficacy, and evidence-seeking behavior in a simulated clinical situation and to present a model of EBM competence.
METHODS


Sixty-one didactic-year PA students from one Midwestern University (2 sequential cohorts) were randomized to receive the standard PA curriculum plus EBM training (intervention) or the standard PA curriculum only (control). Evidence-based medicine knowledge was measured with a validated Fresno test. Self-efficacy was measured with a validated Likert scale. Clinical application of EBM skills was measured with an objective structured clinical examination (OSCE).
RESULTS


Evidence-based medicine education led to significant improvements on the Fresno and self-efficacy tests, both within and between groups. On the OSCE, the intervention group performed no better than the control group. Higher Fresno pretest scores were significantly related to decreasing improvements in the posttest scores: R = -0.634.
CONCLUSION


Teaching EBM to PA students improved their EBM knowledge and self-efficacy but not their clinical application. Future research should focus on enhancing EBM evaluation and application in the clinical setting.",2020,Higher Fresno pretest scores were significantly related to decreasing improvements in the posttest scores:,['Sixty-one didactic-year PA students from one Midwestern University (2 sequential cohorts'],"['Teaching Evidence-Based Medicine', 'standard PA curriculum plus EBM training (intervention) or the standard PA curriculum only (control', 'evidence-based medicine (EBM) education']","['EBM knowledge and self-efficacy', 'Fresno and self-efficacy tests', 'posttest scores', 'Self-efficacy']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.043621,Higher Fresno pretest scores were significantly related to decreasing improvements in the posttest scores:,"[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Stack', 'Affiliation': 'Matthew A. Stack, DHA, PA-C, is an adjunct professor for behavior health at the MSU/MidMichigan Gratiot Family Medicine Residency Program in Alma, Michigan. Nailya O. DeLellis, PhD, MPH, is an associate professor in the Health Administration Program, College of Health Professions, at Central Michigan University in Mt. Pleasant, Michigan. Wallace Boeve, EdD, PA-C, is the program director for the Physician Assistant Program at Bethel University in St. Paul, Minnesota. Robert C. Satonik, MD, is an associate professor at the Medical College of Georgia at Augusta University and assistant dean for clinical curriculum at the Augusta University-University of Georgia Medical Partnership in Athens, Georgia.'}, {'ForeName': 'Nailya O', 'Initials': 'NO', 'LastName': 'DeLellis', 'Affiliation': ''}, {'ForeName': 'Wallace', 'Initials': 'W', 'LastName': 'Boeve', 'Affiliation': ''}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Satonik', 'Affiliation': ''}]",The journal of physician assistant education : the official journal of the Physician Assistant Education Association,['10.1097/JPA.0000000000000313']
1792,32810739,"The mitochondria-targeted antioxidant MitoQ, attenuates exercise-induced mitochondrial DNA damage.","High-intensity exercise damages mitochondrial DNA (mtDNA) in skeletal muscle. Whether MitoQ - a redox active mitochondrial targeted quinone - can reduce exercise-induced mtDNA damage is unknown. In a double-blind, randomized, placebo-controlled design, twenty-four healthy male participants consisting of two groups (placebo; n = 12, MitoQ; n = 12) performed an exercise trial of 4 x 4-min bouts at 90-95% of heart rate max. Participants completed an acute (20 mg MitoQ or placebo 1-h pre-exercise) and chronic (21 days of supplementation) phase. Blood and skeletal muscle were sampled immediately pre- and post-exercise and analysed for nuclear and mtDNA damage, lipid hydroperoxides, lipid soluble antioxidants, and the ascorbyl free radical. Exercise significantly increased nuclear and mtDNA damage across lymphocytes and muscle (P < 0.05), which was accompanied with changes in lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P < 0.05). Acute MitoQ treatment failed to impact any biomarker likely due to insufficient initial bioavailability. However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05). Our work is the first to show a protective effect of chronic MitoQ supplementation on the mitochondrial and nuclear genomes in lymphocytes and human muscle tissue following exercise, which is important for genome stability.",2020,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","['twenty-four healthy male participants consisting of two groups (placebo; n\xa0=\xa012, MitoQ; n\xa0=\xa012']","['High-intensity exercise damages mitochondrial DNA (mtDNA', 'MitoQ or placebo', 'placebo']","['Blood and skeletal muscle', 'lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P', 'nuclear and mtDNA damage across lymphocytes and muscle (P', 'mtDNA damage in lymphocytes and muscle tissue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",24.0,0.192572,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'Ciara M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': 'Ulster University, Nursing and Health Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Cobley', 'Affiliation': 'Free Radical Research Group, University of the Highlands and Islands, Centre for Health Sciences, Inverness, IV2 3JH, UK.'}, {'ForeName': 'Gareth W', 'Initials': 'GW', 'LastName': 'Davison', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK. Electronic address: gw.davison@ulster.ac.uk.'}]",Redox biology,['10.1016/j.redox.2020.101673']
1793,32811378,Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation.,"BACKGROUND AND PURPOSE


We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke.
METHODS


This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed.
RESULTS


Both DOSE1 (mean change 61 m [95% CI, 9-113],  P =0.02) and DOSE2 (mean change 58 m, 6-110,  P =0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care.
CONCLUSIONS


This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01915368.",2020,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","['Subjects (n=75; 25/group', '6 Canadian inpatient rehabilitation units, between 2014 and 2018', 'patients with stroke']","['control (usual care) physical therapy', 'DOSE1']","['DOSE2 in gait speed (5-m walk', 'Walking Recovery', 'quality of life (EQ-5D-5 L', 'DOSE2', 'walking endurance at completion of the 4-week intervention (post-evaluation', 'walking endurance benefits', 'walking endurance']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.0592141,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","[{'ForeName': 'Tara D', 'Initials': 'TD', 'LastName': 'Klassen', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Dukelow', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute (S.P.D., M.D.H.)University of Calgary, Canada.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Bayley', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Toronto, Canada (M.T.B.).'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Benavente', 'Affiliation': 'Division of Neurology (O.B.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute (S.P.D., M.D.H.)University of Calgary, Canada.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Krassioukov', 'Affiliation': 'Division of Physical Medicine and Rehabilitation (A.K., J.Y.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Pooyania', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Manitoba (S.P.).'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': 'Department of Physiology & Pharmacology (M.J.P.) University of Calgary, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schneeberg', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Division of Physical Medicine and Rehabilitation (A.K., J.Y.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Janice J', 'Initials': 'JJ', 'LastName': 'Eng', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}]",Stroke,['10.1161/STROKEAHA.120.029245']
1794,32804212,Effect of Clinician Training in the Modular Approach to Therapy for Children vs Usual Care on Clinical Outcomes and Use of Empirically Supported Treatments: A Randomized Clinical Trial.,"Importance


The Modular Approach to Therapy for Children (MATCH) was developed to address the comorbidities common among clinically referred youth, with beneficial outcomes shown in 2 US randomized clinical trials, where it outperformed both usual clinical care and single disorder-specific treatments.
Objective


To determine whether MATCH training of clinicians would result in more use of empirically supported treatment (EST) and better clinical outcomes than usual care (UC) in the publicly funded, multidisciplinary context of New Zealand.
Design, Setting, and Participants


This multisite, single-blind, computer-randomized clinical effectiveness trial compared MATCH with UC in child and adolescent mental health services in 5 regions of New Zealand. Recruitment occurred from March 2014 to July 2015, and a 3-month follow-up assessment was completed by May 2016. Clinicians at participating child and adolescent mental health services were randomized (1:1) to undertake training in MATCH or to deliver UC, and young people with anxiety, depression, trauma-related symptoms, or disruptive behavior seeking treatment at child and adolescent mental health services were randomized (1:1) to receive MATCH or UC. Participants and research assistants were blind to allocation. Data analysis was performed from April 2016 to July 2017.
Interventions


MATCH comprises EST components for flexible management of common mental health problems. UC includes case management and psychological therapies. Both can include pharmacotherapy.
Main Outcomes and Measures


There were 3 primary outcomes: trajectory of change of clinical severity, as measured by weekly ratings on the Brief Problem Monitor (BPM); fidelity to EST content, as measured by audio recordings of therapy sessions coded using the Therapy Integrity in Evidence Based Interventions: Observational Coding System; and efficiency of service delivery, as measured by duration of therapy (days) and clinician time (minutes).
Results


The study included 65 clinicians (mean age, 38.7 years; range, 23.0-64.0 years; 54 female [83%]; MATCH, 32 clinicians; UC, 33 clinicians) and 206 young people (mean age, 11.2 years; range 7.0-14.0 years; 122 female [61%]; MATCH, 102 patients; UC, 104 patients). For the BPM total ratings for parents, there was a mean (SE) slope of -1.04 (0.14) (1-year change, -6.12) in the MATCH group vs -1.04 (0.10) (1-year change, -6.17) in the UC group (effect size, 0.00; 95% CI, -0.27 to 0.28; P = .96). For the BPM total for youths, the mean (SE) slope was -0.74 (0.15) (1-year change, -4.35) in the MATCH group vs -0.73 (0.10) (1-year change, -4.32) in the UC group (effect size, -0.02; 95% CI, -0.30 to 0.26; P = .97). Primary analyses (intention-to-treat) showed no difference in clinical outcomes or efficiency despite significantly higher fidelity to EST content in the MATCH group (58 coded sessions; mean [SD], 80.0% [20.0%]) than the UC group (51 coded sessions; mean [SD], 57.0% [32.0%]; F(1,108) = 23.0; P < .001). With regard to efficiency of service delivery, there were no differences in total face-to-face clinician time between the MATCH group (mean [SD], 806 [527] minutes) and the UC group (mean [SD], 677 [539] minutes) or the overall duration of therapy between the MATCH group (mean [SD], 167 [107 days]) and the UC group (mean [SD], 159 [107] days).
Conclusions and Relevance


MATCH significantly increased adherence to EST practices but did not improve outcomes or efficiency. The nonsuperiority of MATCH may be attributable to high levels of EST use in UC in New Zealand.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614000297628.",2020,"Primary analyses (intention-to-treat) showed no difference in clinical outcomes or efficiency despite significantly higher fidelity to EST content in the MATCH group (58 coded sessions; mean [SD], 80.0% [20.0%]) than the UC group (51 coded sessions; mean [SD], 57.0% [32.0%]; F(1,108) = 23.0; P < .001).","['young people with anxiety, depression, trauma-related symptoms, or disruptive behavior seeking treatment at child and adolescent mental health services', '65 clinicians (mean age, 38.7 years; range, 23.0-64.0 years; 54 female [83%]; MATCH, 32 clinicians; UC, 33 clinicians) and 206 young people (mean age, 11.2 years; range 7.0-14.0 years; 122 female [61%]; MATCH, 102 patients; UC, 104 patients', 'Children (MATCH', 'child and adolescent mental health services in 5 regions of New Zealand', 'Clinicians at participating child and adolescent mental health services']","['undertake training in MATCH or to deliver UC', 'MATCH with UC', 'MATCH or UC', 'Clinician Training']","['overall duration of therapy', 'total face-to-face clinician time', 'mean (SE) slope', 'BPM total ratings', 'change of clinical severity, as measured by weekly ratings on the Brief Problem Monitor (BPM); fidelity to EST content, as measured by audio recordings of therapy sessions coded using the Therapy Integrity in Evidence Based Interventions: Observational Coding System; and efficiency of service delivery, as measured by duration of therapy (days) and clinician time (minutes', 'fidelity to EST content']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0454766', 'cui_str': 'Regions of New Zealand'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}]",65.0,0.108387,"Primary analyses (intention-to-treat) showed no difference in clinical outcomes or efficiency despite significantly higher fidelity to EST content in the MATCH group (58 coded sessions; mean [SD], 80.0% [20.0%]) than the UC group (51 coded sessions; mean [SD], 57.0% [32.0%]; F(1,108) = 23.0; P < .001).","[{'ForeName': 'Sally N', 'Initials': 'SN', 'LastName': 'Merry', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mathijs F G', 'Initials': 'MFG', 'LastName': 'Lucassen', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stasiak', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Christopher M A', 'Initials': 'CMA', 'LastName': 'Frampton', 'Affiliation': 'Department of Psychological Medicine, Christchurch School of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Sarah Kate', 'Initials': 'SK', 'LastName': 'Bearman', 'Affiliation': 'Department of Educational Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Ugueto', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Herren', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Ainsleigh', 'Initials': 'A', 'LastName': ""Cribb-Su'a"", 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kingi-Uluave', 'Affiliation': 'Le Va, Harakeke House, Manukau, Auckland, New Zealand.'}, {'ForeName': 'Jik', 'Initials': 'J', 'LastName': 'Loy', 'Affiliation': 'Infant, Child and Adolescent Mental Health Services, Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'Morgyn', 'Initials': 'M', 'LastName': 'Hartdegen', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Crengle', 'Affiliation': 'Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.11799']
1795,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
1796,32798588,Anti-erosive effect of rinsing before or after toothbrushing with a Fluoride/Stannous Ions solution: an in situ investigation: Application order of Fluoride/Tin products for erosive tooth wear.,"OBJECTIVE


To evaluate the impact of the application of a F - /Sn 2+ -containing mouthrinse before or after toothbrushing with a F - /Sn 2+ /chitosan toothpaste on the progression of erosion/abrasion on enamel and dentin.
METHODS


This crossover in situ study had five arms: Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing + Rinsing, Rinsing + Brushing, and Rinsing (without toothbrushing). Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to erosion-abrasion cycling of 60 min salivary pellicle formation followed by 5 min extra-oral erosion with 1% citric acid (4x/day for 5 days). Treatments were performed in situ after first and last erosive challenges with rinse (10 ml; 30 s) and/or toothbrushing with/without toothpaste (with electric toothbrush; 5 s per specimen; total 2 min contact with slurry). Surface loss (SL) was evaluated with an optical profilometer. Data were analyzed by two-way repeated measures ANOVA and Tukey tests (α = 0.05).
RESULTS


The Control showed the highest SL (mean ± SD for enamel: 24.58 ± 11.32; dentin: 32.32 ± 10.10; all μm). Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing. None of the arms that underwent toothbrushing with the toothpaste differed from each other (p > 0.05). Dentin specimens showed significantly higher SL values than enamel (p < 0.001).
CONCLUSION


The order of treatment applications had no influence on their anti-erosive effect; however, toothbrushing with F - /Sn 2+ /chitosan toothpaste reduced enamel surface loss. Additional rinsing with F - /Sn 2+  mouthrinse did not offer improved protection.
CLINICAL SIGNIFICANCE


The use of fluoride- and stannous- containing toothpastes and mouthrinses is an important approach in the prevention of erosive tooth wear. Further evidence is needed to support the benefit of combining these products against this condition.",2020,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","['Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to']","['Rinsing', 'erosion-abrasion cycling of 60\u2009min salivary pellicle formation followed by 5\u2009min extra-oral erosion with 1% citric acid', 'fluoride- and stannous- containing toothpastes and mouthrinses', 'Fluoride/stannous Ions Solution', 'F-/Sn2+/chitosan toothpaste', 'F-/Sn2+ mouthrinse', 'Fluoride/Tin products', 'Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing\u2009+\u2009Rinsing, Rinsing\u2009+\u2009Brushing, and Rinsing (without toothbrushing', 'toothbrushing with/without toothpaste (with electric toothbrush; 5\u2009s per specimen; total 2\u2009min contact with slurry', 'F-/Sn2+-containing mouthrinse']","['Surface loss (SL', 'progression of erosion/abrasion on enamel and dentin', 'protection', 'enamel surface loss', 'SL values', 'SL value']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0225144,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: alanam@usp.br.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Sakae', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: leticia.sakae@usp.br.'}, {'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: thiago.saads@zmk.univbe.ch.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, University of Texas Health Science Center of San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: tais.sca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103450']
1797,32799029,Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women.,"STUDY OBJECTIVES


To determine whether insomnia patients with objective sleep disturbance are less responsive to cognitive and behavioral treatments than those without objective sleep disturbance, characterize effects of insomnia therapy on objective sleep, and determine whether reductions in nocturnal cognitive arousal correspond to changes in objective sleep.
METHODS


Secondary analysis of a single-site, randomized controlled trial. 113 postmenopausal women (56.40 ± 5.34 years) with menopause-related insomnia disorder were randomized to three treatment conditions: cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control. Primary outcomes were the Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters and were collected at pretreatment, posttreatment, and six-month follow-up.
RESULTS


Patients with lower pretreatment PSG sleep efficiency had lower rates of insomnia remission after active treatment relative to those with higher sleep efficiency (37.8% vs 61.8%). Neither CBTI and SRT produced clinically meaningful effects on PSG sleep. Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
CONCLUSIONS


Our findings support an emerging literature suggesting that insomnia patients with objective sleep disturbance may have blunted response to insomnia therapy. Research is needed to enhance treatments to better improve insomnia in patients with objective sleep disturbance. A lack of observed CBTI and SRT effects on PSG sleep suggests that these therapies may be presently ill-designed to improve objective sleep. Nocturnal cognitive arousal may represent an entry point to improve objective sleep latency in insomnia. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.",2020,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","['insomnia patients with objective sleep disturbance', 'postmenopausal women', 'patients with objective sleep disturbance', '113 postmenopausal women (56.40\xa0±\xa05.34 years) with menopause-related insomnia disorder']","['NAME', 'CBTI and SRT', 'cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control']","['Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters', 'PSG sleep', 'nocturnal cognitive arousal', 'Nocturnal cognitive arousal', 'PSG sleep latency', 'sleep efficiency', 'insomnia remission']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",113.0,0.0431924,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Chaewon', 'Initials': 'C', 'LastName': 'Sagong', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA. Electronic address: cdrake1@hfhs.org.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.024']
1798,32799042,Continuous positive airway pressure effectively ameliorates arrhythmias in patients with obstructive sleep apnea-hypopnea via counteracting the inflammation.,"INTRODUCTION


This work is aimed at evaluating the therapeutic effect of continuous positive airway pressure (CPAP) in treatment of patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) combined with arrhythmias as well as clarifying the possible mechanism underpinning such an intervention.
METHODS


Through exclusions, a total of 108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work. A computerized permuted block design with varying block stratification and size according to age, sex, AHI and type of arrhythmia was used to randomize 108 patients to CPAP versus sham CPAP for a period of 12-week. All were subjected to unchanged pharmacological anti-arrhythmia therapy combined with CPAP. Before and after CPAP treatment, the improvement of various arrhythmias was compared between the CPAP group and the sham-CPAP group. The levels of CRP, IL-6 and TNF-ɑ were measured simultaneously.
RESULTS


During follow-up, the mean (±SD) CPAP pressure used in the CPAP group was 12.3 (±3.1) cm H2O. The use of CPAP and sham CPAP was on average of 5.2 ± 0.56 and 5.1 ± 0.63 h/night, respectively. After 12 weeks of CPAP therapy, the AHI was significantly decreased and the lowest blood oxygen saturation was notably elevated in the CPAP group compared to the sham-CPAP group, P < 0.05. The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS. The level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) was significantly lower in the CPAP group than in the sham-CPAP group (P < 0.05). Pearson correlation analysis showed that the reduction in the incidence of total arrhythmias was positively correlated with the decrease of CRP, IL-6 and TNF-ɑ levels, respectively.
CONCLUSION


Findings from this work suggest that proper use of CPAP significantly benefits to OSAHS patients combined with arrhythmias, possibly via counteracting the inflammation.",2020,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","['patients with obstructive sleep apnea-hypopnea via counteracting the inflammation', '108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work', 'patients with obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with OSAHS']","['CPAP versus sham CPAP', 'CPAP', 'continuous positive airway pressure (CPAP', 'pharmacological anti-arrhythmia therapy combined with CPAP', 'Continuous positive airway pressure', 'CPAP and sham CPAP']","['mean (±SD) CPAP pressure', 'incidence of total arrhythmias', 'lowest blood oxygen saturation', 'improvement of various arrhythmias', 'CRP, IL-6 and TNF-ɑ levels', 'level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', 'incidence of all types of arrhythmia', 'levels of CRP, IL-6 and TNF-ɑ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",108.0,0.024615,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","[{'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Minglu', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 250021, PR China. Electronic address: zg000507@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102655']
1799,32799056,Comparing the impact of educational messages based on an extended parallel process model on solid waste separation behaviors in female students: A four-group randomized trial.,"BACKGROUND


The increase in non-separated solid waste is a threat to environmental health. People may be motivated to reduce the destructive effects of waste accumulation in the environment by receiving educational messages and learning the proper methods of waste separation. This study aimed to determine the effect of educational messages on waste separation in dormitory students based on Extended Parallel Process Model (EPPM).
METHODS


This randomized controlled trial was performed on 320 students categorized into four groups from October to December 2019. After installing waste separation tags on separate containers, three types of messages were presented to encourage and educate waste separation in the following four groups: threat messages; efficacy messages; threat/efficacy messages; and control group. Data were collected prior to and one week after training by a self-reported valid and reliable questionnaire. They were analyzed in SPSS21.
RESULTS


In the efficacy group and threat/efficacy group, not only the mean scores of ""perceived threat associated with non-segregation and waste accumulation"", ""attitude"" and ""intention"" but also the mean score of ""efficacy"" and ""waste separation behavior"" were improved (P < 0.05). In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
DISCUSSION


Use of efficacy-based massages alone or in combination with the threat component was proposed to promote waste separation. No specific study has documented the effectiveness of messages based on EPPM on solid waste separation behaviors. The current study highlighted the effectiveness of using EPPM to promote waste-separation behavior in practice, not in theory.",2020,"In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
","['female students', '320 students categorized into four groups from October to December 2019', 'dormitory students based on Extended Parallel Process Model (EPPM']","['educational messages', 'EPPM']","['mean score of ""perceived barriers"" for waste separation', 'mean score of ""efficacy"" and ""waste separation behavior', 'mean scores of ""perceived threat associated with non-segregation and waste accumulation"", ""attitude"" and ""intention']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0080141', 'cui_str': 'Racial Segregation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",320.0,0.0326594,"In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
","[{'ForeName': 'Aazam', 'Initials': 'A', 'LastName': 'Abbasi', 'Affiliation': 'Student Research Committee, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Araban', 'Affiliation': 'Health Education and Promotion Department, Public Health School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Alidosti', 'Affiliation': 'Department of Public Health, Behbahan Faculty of Medical Sciences, Behbahan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Zamani-Alavijeh', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: fe.zamani@hlth.mui.ac.ir.'}]","Waste management (New York, N.Y.)",['10.1016/j.wasman.2020.07.041']
1800,32799180,The effect of small versus large clog size on emergency response time: A randomized controlled trial.,"OBJECTIVES


To assess the effect on healthcare professional emergency response time and safety of small compared to large clog size.
DESIGN


Randomized controlled trial.
SETTING


The intensive care unit of a single university medical centre in The Netherlands.
PARTICIPANTS


Intensive care medicine professionals.
INTERVENTIONS


Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125 m course from the coffee break room to the elevator providing access to the emergency department.
MAIN OUTCOME MEASURES


The primary outcome was the time to complete the running course. Height, shoe size, self-described fitness, age and staff category were investigated as possible effect modifiers. Secondary endpoints were reported clog comfort and suspected unexpected clog-related adverse events (SUCRAEs).
RESULTS


50 participants were randomized (25 to European size 38 clogs and 25 to size 47 clogs). Mean age was 37 years (SD 12) and 29 participants (58%) were female. The primary outcome was 4.4 s (95% CI -7.1; -1.6) faster in the size 5 clogs group compared to the size 12 clogs group. This effect was not modified by any of the predefined participant characteristics. No differences were found in reported clog comfort or SUCRAEs.
CONCLUSIONS


European size 38 clogs lead to faster emergency response times than size 47 clogs.
TRIAL REGISTRATION


NCT04406220.",2020,"No differences were found in reported clog comfort or SUCRAEs.
","['Intensive care medicine professionals', 'The intensive care unit of a single university medical centre in The Netherlands', 'Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125\xa0m course from the coffee break room to the elevator providing access to the emergency department', 'Mean age was 37\xa0years (SD 12) and 29 participants (58%) were female', '50 participants']",[],"['clog comfort and suspected unexpected clog-related adverse events (SUCRAEs', 'time to complete the running course', 'emergency response time', 'Height, shoe size, self-described fitness, age and staff category']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0013890', 'cui_str': 'Elevator'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0426931', 'cui_str': 'Shoe size'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",50.0,0.195819,"No differences were found in reported clog comfort or SUCRAEs.
","[{'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands. Electronic address: p.elbers@amsterdamumc.nl.'}, {'ForeName': 'Harm-Jan', 'Initials': 'HJ', 'LastName': 'de Grooth', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}]",Journal of critical care,['10.1016/j.jcrc.2020.07.028']
1801,32799933,Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial.,"BACKGROUND


There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality.
METHODS/DESIGN


This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO 2 /FiO 2  ≤ 200 mmHg on PEEP ≥ 10 cmH 2 O and FiO 2  ≥ 0.5 after 12 ± 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle.
DISCUSSION


This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04325061 . Registered on 25 March 2020 as DEXA-COVID19.",2020,"The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization.","['200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection', 'patients with established moderate-to-severe ARDS caused by SARS-CoV-2', 'patients with the acute respiratory distress syndrome caused by COVID-19', 'Eligible patients']","['dexamethasone', 'corticosteroids', 'dexamethasone plus standard intensive care or standard intensive care alone']","['duration of mechanical ventilation and in mortality', 'pulmonary and systemic inflammatory response', 'number of ventilator-free days, defined as days alive and free from mechanical ventilation', '60-day mortality']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",,0.322383,"The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. jesus.villar54@gmail.com.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Añón', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrando', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Aguilar', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universitario, Valencia, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Muñoz', 'Affiliation': 'Intensive Care Unit, Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ferreres', 'Affiliation': 'Intensive Care Unit, Hospital Clínico Universitario, Valencia, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ambrós', 'Affiliation': 'Intensive Care Unit, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Aldecoa', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Suárez-Sipmann', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Applied Health Research Center, Li Ka Shing Knowledge Institute, Toronto, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Applied Health Research Center, Li Ka Shing Knowledge Institute, Toronto, Canada.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04643-1']
1802,32800029,[Effect of intermittent versus daily inhalation of budesonide on pulmonary function and fractional exhaled nitric oxide in children with mild persistent asthma].,"OBJECTIVE


To study the effect of intermittent versus daily inhalation of budesonide on pulmonary function and fractional exhaled nitric oxide (FeNO) in children with mild persistent asthma.
METHODS


A total of 120 children, aged 6-14 years, with mild persistent asthma who attended the hospital from January 2016 to January 2018 were enrolled. The children were divided into an intermittent inhalation group with 60 children (inhalation of budesonide 200 μg/day for 6 weeks when symptoms of asthma appeared) and a daily inhalation group with 60 children (continuous inhalation of budesonide 200 μg/day) by stratified randomization. The children were followed up at months 3, 6, 9, and 12 of treatment. The two groups were compared in terms of baseline data, changes in FeNO and pulmonary function parameters, amount of glucocorticoid used, number of asthma attacks, and asthma control.
RESULTS


At the start of treatment, there were no significant differences in baseline data, FeNO, and pulmonary function between the two groups (P>0.05). Over the time of treatment, FeNO gradually decreased and pulmonary function parameters were gradually improved in both groups (P<0.001). Compared with the intermittent inhalation group, the daily inhalation group had a better effect in reducing FeNO and increasing the predicted percentage of forced expiratory volume in 1 second (FEV1%pred) (P<0.001). The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001). In the daily inhalation group, FeNO and lung function parameters were improved rapidly and stabilized after 3 months of treatment, while those in the intermittent inhalation group stabilized after 6 months. After 12 months of treatment, there were no significant differences in the increases in body height and body weight and the degree of disease control between the two groups (P>0.05). Compared with the daily inhalation group, the intermittent inhalation group had a significantly lower amount of budesonide inhaled (P<0.05) and a significantly higher number of asthma attacks (P<0.05).
CONCLUSIONS


Intermittent inhalation and daily inhalation of budesonide can achieve the same level of asthma control in children with mild persistent asthma and both have no influence on the increases in body height and body weight. Daily inhalation of budesonide can produce a better efficiency in reduing FeNO and increasing FEV1%pred. Although intermittent inhalation can reduce the amount of glucocorticoid used, it may lead to a higher risk of asthma attacks.",2020,The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001).,"['children with mild persistent asthma', '120 children, aged 6-14 years, with mild persistent asthma who attended the hospital from January 2016 to January 2018 were enrolled']","['intermittent inhalation group with 60 children (inhalation of budesonide 200\u2005μg/day for 6 weeks when symptoms of asthma appeared) and a daily inhalation group with 60 children (continuous inhalation of budesonide', 'budesonide']","['pulmonary function and fractional exhaled nitric oxide', 'FeNO and lung function parameters', 'number of asthma attacks', 'baseline data, FeNO, and pulmonary function', 'forced expiratory volume', 'body height and body weight and the degree of disease control', 'pulmonary function and fractional exhaled nitric oxide (FeNO', 'FeNO and pulmonary function parameters', 'FeNO', 'pulmonary function parameters', 'body height and body weight', 'FeNO and pulmonary function parameters, amount of glucocorticoid used, number of asthma attacks, and asthma control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960046', 'cui_str': 'Mild persistent asthma'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",120.0,0.0254881,The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001).,"[{'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, Fifth People's Hospital of Shanghai, Fudan University, Shanghai 200240, China. wxmyj@sina.com.""}, {'ForeName': 'Wen-Xuan', 'Initials': 'WX', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Wang', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
1803,32800078,"Searching for Personalized Medicine for Binge Drinking Smokers: Smoking Cessation Using Varenicline, Nicotine Patch, or Combination Nicotine Replacement Therapy.","OBJECTIVE


Heavy drinking is common among smokers and is associated with especially poor health outcomes. Varenicline may affect mechanisms and clinical outcomes that are relevant for both smoking cessation and alcohol use. The current study examines whether varenicline, relative to nicotine replacement therapy, yields better smoking cessation outcomes among binge drinking smokers.
METHOD


Secondary data analyses of a comparative effectiveness randomized controlled trial of three smoking cessation pharmacotherapies (12 weeks of varenicline, nicotine patch, or nicotine patch and lozenge) paired with six counseling sessions were conducted. Adult daily cigarette smokers (N = 1,078, 52% female) reported patterns of alcohol use, cigarette craving, and alcohol-related cigarette craving at baseline and over 4 weeks after quitting. Smoking cessation outcome was 7-day biochemically confirmed point-prevalence abstinence.
RESULTS


Binge drinkers had higher relapse rates than moderate drinkers at 4-week post-target quit day but not at the end of treatment or long-term follow up (12 and 26 weeks). Varenicline did not yield superior smoking cessation outcomes among binge drinkers, nor did it affect alcohol use early in the quit attempt. Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
CONCLUSIONS


Varenicline did not yield higher smoking abstinence rates or reduce alcohol use among binge drinkers. Varenicline did reduce alcohol-related cigarette craving but this did not translate to meaningful differences in smoking abstinence. Varenicline's effects on smoking abstinence do not appear to vary significantly as a function of drinking status.",2020,"Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
","['Binge Drinking Smokers', 'Adult daily cigarette smokers (N = 1,078, 52% female) reported patterns of alcohol use, cigarette craving, and alcohol-related cigarette craving at baseline and over 4 weeks after quitting', 'binge drinking smokers']","['Varenicline, Nicotine Patch, or Combination Nicotine Replacement Therapy', 'smoking cessation pharmacotherapies', 'Varenicline', 'varenicline', 'nicotine replacement therapy', 'varenicline, nicotine patch, or nicotine patch and lozenge) paired with six counseling sessions']","['alcohol-related cigarette craving', 'smoking abstinence', 'relapse rates', 'alcohol-related cigarette craving and overall cigarette craving', 'Smoking cessation outcome', 'smoking abstinence rates']","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.0099727,"Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
","[{'ForeName': 'Jesse T', 'Initials': 'JT', 'LastName': 'Kaye', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}, {'ForeName': 'Adrienne L', 'Initials': 'AL', 'LastName': 'Johnson', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}]",Journal of studies on alcohol and drugs,[]
1804,32800081,"Effects of Alcohol, Condom Request Style, and State Anger on Men's Condom Use Resistance.","OBJECTIVE


The purpose of this study was to examine the distal predictors (alcohol expectancies, adversarial heterosexual beliefs) and proximal predictors (alcohol intoxication, partner's condom use request style, state anger) of young men's condom use resistance (CUR).
METHOD


Young, male, non-problem drinking, inconsistent condom users (N = 297) completed an alcohol administration experiment. After completing background measures, participants were randomly assigned to receive a control or alcoholic beverage (target peak breath alcohol concentration = .08%). They then read a randomly assigned hypothetical sexual scenario in which their female partner requested to use a condom either indirectly, directly, or insistently. Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
RESULTS


Path analyses demonstrated that alcohol intoxication directly predicted noncoercive CUR intentions. In addition, a moderated mediation pathway was found such that, relative to sober participants, intoxicated men's sexual aggression-related alcohol expectancies were positively associated with their state anger in response to the partner's condom use request. This increased anger was related to stronger noncoercive CUR intentions. Adversarial heterosexual beliefs both directly and indirectly predicted coercive and noncoercive CUR intentions.
CONCLUSIONS


Path analysis demonstrated that alcohol intoxication increased intentions to resist condom use through noncoercive tactics. In addition, men's misogynistic attitudes and alcohol intoxication were associated with greater feelings of anger, which predicted stronger coercive and noncoercive CUR intentions.",2020,"Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
","['Young, male, non-problem drinking, inconsistent condom users (N = 297) completed an alcohol administration experiment']","['control or alcoholic beverage', 'Alcohol, Condom Request Style, and State Anger']","[""distal predictors (alcohol expectancies, adversarial heterosexual beliefs) and proximal predictors (alcohol intoxication, partner's condom use request style, state anger) of young men's condom use resistance (CUR"", 'noncoercive CUR intentions', 'sexual aggression-related alcohol expectancies', ""Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0233953', 'cui_str': 'Sexual aggression'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",297.0,0.0222601,"Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cue Davis', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Kirwan', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Rhiana', 'Initials': 'R', 'LastName': 'Wegner', 'Affiliation': 'University of Massachusetts, Boston, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Neilson', 'Affiliation': 'Department of Psychology, Morehead State University, Morehead, Kentucky.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Stappenbeck', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia.'}]",Journal of studies on alcohol and drugs,[]
1805,32801193,REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.,"INTRODUCTION


Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system. It is considered a major cause of non-traumatic disability in young adults. One of the most common and disabling symptoms of MS is fatigue. MS fatigue can impact all aspects of quality of life, including physical, mental and social function. Fortunately, fatigue self-management interventions, such as ' Managing Fatigue: A 6 week energy conservation course' , can decrease the impact of fatigue and improve health-related quality of life. The purpose of this study is to compare three modes of delivering the  Managing Fatigue  intervention-two remote delivery formats (teleconference and internet) and one in-person format-on perceptions of fatigue and its impact on physical, mental and social function.
METHODS AND ANALYSIS


A non-inferiority randomised clinical trial is being conducted to compare the three delivery formats (1:1:1 allocation ratio) among 582 participants with MS living in the Midwestern and Northeastern United States. The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale). Outcomes are being measured at baseline, 2 months, 3 months and 6 months. The primary analysis tool will be linear mixed effects model. The prespecified inferiority margin for the primary outcome is 10 points. We will also examine whether baseline characteristics (eg, sociodemographic) moderate outcomes of the  Managing Fatigue  intervention and whether changes in self-efficacy and fatigue self-management behaviours mediate changes in outcomes.
ETHICS AND DISSEMINATION


The protocol is approved centrally by the institutional review board at Case Western Reserve University. Eligible participants give consent before being enrolled and randomised into the study. The study results will be disseminated through relevant advocacy organisations, newsletters to participants, publication in peer-reviewed journals and presentations at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03550170; Pre-results.",2020,"The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale).","['persons with multiple sclerosis', 'young adults', 'Eligible participants give consent before being enrolled and randomised into the study', '582 participants with MS living in the Midwestern and Northeastern United States']",['Managing Fatigue  intervention-two remote delivery formats (teleconference and internet'],"['MS fatigue', 'quality of life, including physical, mental and social function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",582.0,0.146994,"The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Plow', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio, USA map208@case.edu.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Packer', 'Affiliation': 'School of Occupational Therapy and School of Health Administration, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Virgil G', 'Initials': 'VG', 'LastName': 'Mathiowetz', 'Affiliation': 'Program in Occupational Therapy, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Preissner', 'Affiliation': 'Department of Occupational Therapy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Ghahari', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bethoux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-035470']
1806,32801202,"Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.","INTRODUCTION


The WHO recommends daily oral iron supplementation for 12 weeks in women and adolescents where anaemia prevalence is greater than 40%. However, if iron deficiency is not a major cause of anaemia, then, at best, untargeted iron supplementation is a waste of resources; at worst, it could cause harm. Further, different forms of iron with varying bioavailability may present greater risks of harm.
METHODS AND ANALYSIS


A 12-week three-arm, double-blind, randomised controlled supplementation trial was conducted in Cambodia to determine if there is potential harm associated with untargeted iron supplementation. We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo. We will measure ferritin concentrations (to evaluate non-inferiority between the two forms of iron), as well as markers of potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage) at baseline and 12 weeks. Mixed-effects generalised linear models will be used to assess the effect of iron on ferritin concentration and markers of potential harm at 12 weeks.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of British Columbia Clinical Research Ethics Board (H18-02610), the Children's and Women's Health Centre of British Columbia Research Ethics Board (H18-02610) and the National Ethics Committee for Health Research in Cambodia (273-NECHR). Findings will be published in peer-reviewed journals, presented to stakeholders and policymakers globally and shared within participants' communities.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04017598).",2020,"We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo.","['non-pregnant Cambodian women', '480 non-pregnant women (ages 18-45 years']","['oral iron supplementation', 'elemental iron as ferrous sulfate (the standard, commonly used form), 18\u2009mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo']","['anaemia prevalence', 'potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage', 'ferritin concentrations']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1721498', 'cui_str': 'ferrous bisglycinate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.77336,"We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo.","[{'ForeName': 'Jordie Aj', 'Initials': 'JA', 'LastName': 'Fischer', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lulu X', 'Initials': 'LX', 'LastName': 'Pei', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Goldfarb', 'Affiliation': ""Healthy Starts, British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': ""Department of Biostatistics, Women's Health Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': ""Healthy Starts, British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Hou', 'Initials': 'H', 'LastName': 'Kroeun', 'Affiliation': 'Helen Keller International Cambodia, Phnom Penh, British Columbia, Cambodia.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada Crystal.Karakochuk@ubc.ca.'}]",BMJ open,['10.1136/bmjopen-2020-037232']
1807,32802039,Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study.,"Background


Transcutaneous auricular vagus nerve stimulation (taVNS) is regarded as a potential method for recovery in stroke. The effectiveness of taVNS in acute and subacute stroke should be further discussed as previously, only a few small-scale trials have focused on chronic stroke patients. The objective of this study is to investigate the effect and safety of taVNS on upper limb motor function in subacute ischemic stroke patients.
Methods


Twenty-one subacute ischemia stroke patients with single upper limb motor function impairment were enrolled and randomly assigned to conventional rehabilitation training with real or sham taVNS, delivered for 15 consecutive days. Electrodes were fixed to the cymba conchae of the left ear with or without electrical stimulation. Conventional rehabilitation training was performed immediately after the end of real or sham taVNS by the same therapists. Baseline assessments were performed on day 0 of enrollment, and posttreatment evaluations were performed at 15 days, 4 weeks, and 12 weeks after the first intervention. The assessment included the upper limb Fugl-Meyer assessment (FMA-U), the Wolf motor function test (WMFT), the Functional Independence Measurement (FIM), and Brunnstrom stage. Heart rate (HR) and blood pressure (BP) were measured before and after each taVNS intervention. At the same time, any adverse effects were observed during the procedure. Outcomes were assessed by a blind evaluator.
Results


There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline ( P  > 0.05). At the endpoint, the FMA-U, WMFT, and FIM scores were significantly higher than before treatment ( P  < 0.05), and there was a significantly greater improvement of those measurements in taVNS group compared with sham-taVNS group ( P  < 0.05). Significant improvements in FMA-U score were found between groups at follow-up. Only one case of skin redness occurred during the study.
Conclusions


This study revealed that taVNS appeared to be beneficial to the recovery of upper limb motor function in subacute ischemia stroke patients without obvious adverse effects.  Trial registration . This trial is registered with ChiCTR1800019635 on 20 November 2018 (http://www.chictr.org.cn/showproj.aspx?proj=32961).",2020,"There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline ( P  > 0.05).","['20 November 2018 (http://www.chictr.org.cn/showproj.aspx?proj=32961', 'subacute ischemia stroke patients', 'Methods\n\n\nTwenty-one subacute ischemia stroke patients with single upper limb motor function impairment', 'Subacute Ischemic Stroke Patients', 'subacute ischemic stroke patients', 'chronic stroke patients']","['Transcutaneous Auricular Vagus Nerve Stimulation', 'taVNS', 'conventional rehabilitation training with real or sham taVNS', '\n\n\nTranscutaneous auricular vagus nerve stimulation (taVNS', 'Conventional rehabilitation training']","['FMA-U score', 'skin redness', 'FMA-U, WMFT, FIM, and Brunnstrom scores', 'Heart rate (HR) and blood pressure (BP', 'FMA-U, WMFT, and FIM scores', 'adverse effects', 'upper limb Fugl-Meyer assessment (FMA-U), the Wolf motor function test (WMFT), the Functional Independence Measurement (FIM), and Brunnstrom stage']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",21.0,0.0807745,"There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline ( P  > 0.05).","[{'ForeName': 'Dandong', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Jingxi', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Chongqing General Hospital, University of Chinese Academy of Sciences, Yuzhong District, Chongqing 400013, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Chongqing Medical University, 1 Yixueyuan Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Sanrong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Gongwei', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}]",Neural plasticity,['10.1155/2020/8841752']
1808,32818325,Randomized trial of cognitive behaviour group therapy and a mindfulness-based intervention for social anxiety disorder: Preliminary findings.,"Recent studies have evaluated the possible efficacy of mindfulness-based interventions (MBIs) for social anxiety disorder (SAD). However, few trials have compared MBIs with a first-line treatment. This study evaluated the relative efficacy of an MBI adapted for SAD (MBI-SAD) to cognitive behaviour group therapy (CBGT) for SAD. Participants were randomized to 12 weekly group sessions of the MBI-SAD (n = 52) or CBGT (n = 45). Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity. The difference between the MBI-SAD and CBGT exceeded the prespecified noninferiority margin for our primary outcome the Liebowitz Social Anxiety Scale, but findings are inconclusive as the width of the confidence interval extended in both directions surrounding the noninferiority margin. The MBI-SAD compared favourably with CBGT in improving other indices of well-being (depression, self-esteem, satisfaction with life, social adjustment). Contrary to expectation, the MBI-SAD did not produce greater changes in mindfulness and self-compassion than CBGT. Overall, results confirm that CBGT is robust treatment for SAD and should be considered as first-line treatment.",2020,Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity.,['Social Anxiety Disorder'],"['MBI-SAD (n=52) or CBGT', 'Cognitive Behavior Group Therapy and a Mindfulness-based Intervention', 'CBGT', 'MBI adapted for SAD (MBI-SAD) to cognitive behavior group therapy (CBGT', 'MBI-SAD', 'mindfulness-based interventions (MBIs']","['MBI-SAD and CBGT', 'Liebowtiz Social Anxiety Scale', 'clinician- and self-rated social anxiety severity', 'mindfulness and self-compassion', 'indices of well-being (depression, self-esteem, satisfaction with life, social adjustment']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0215358,Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity.,"[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Koszycki', 'Affiliation': 'Faculty of Education (Counselling Psychology), University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Guérin', 'Affiliation': 'Montfort Hospital, Institut du Savoir Montfort, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'DiMillo', 'Affiliation': 'Montfort Hospital, Institut du Savoir Montfort, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bradwejn', 'Affiliation': 'Faculty of Medicine (Psychiatry), University of Ottawa, Ottawa, Ontario.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2502']
1809,32818328,"Intraindividual comparison of cytokine and prostaglandin levels with and without low-energy, high-frequency femtosecond laser cataract pretreatment after single-dose topical NSAID application.","PURPOSE


To investigate interleukin (IL)-1β, IL-6, and total prostaglandin (PG) levels in the anterior chamber in patients undergoing low pulse energy femtosecond laser-assisted cataract surgery.
METHODS


Forty patients undergoing immediate sequential cataract surgery received randomized low-energy femtosecond laser pretreatment in 1 eye and conventional phacoemulsification in the other. Aqueous humor was collected precisely 5 minutes after femtosecond laser pretreatment and before conventional phacoemulsification from all 80 eyes. IL-1β, IL-6, and total PG (including PGE1, PGE2; PGF1a, PGF2a) levels were analyzed using enzyme-linked immunoassay kits. One drop of ketorolac 0.5% was administered 30 minutes preoperatively.
RESULTS


Mean concentrations of IL-1β, IL-6, and total PG were 0.87, 0.67, and 32.19 pg/mL in the femto group compared with 0.10 (P = .36), 0.78 (P = .79), and 19.66 pg/mL (P < .05) in the nonfemto group. Levels of IL-1β and IL-6 were not statistically significantly different when compared between groups. There was a small but statistically significant increase of PG levels in the femto group. There were no statistically significant correlations between levels of 1β, IL-6, or total PG and suction time or lens density (P > .05).
CONCLUSIONS


Low pulse energy femtosecond laser pretreatment did not trigger any additional IL and only a small but statistically significant increase of PG release in the anterior chamber after a single-dose of topical nonsteroidal antiinflammatory drug administered 30 minutes before the start of cataract surgery. The findings indicated that the minor inflammatory reaction was due to the lower pulse energy concept applied by the femtosecond laser.",2020,"Mean concentrations of IL-1β, IL-6, and total PG were 0.87, 0.67, and 32.19 pg/mL in the femto group compared with 0.10 (P = .36), 0.78","['patients undergoing', 'Forty patients undergoing immediate sequential cataract surgery received']","['cytokine and prostaglandin levels with and without low-energy, high-frequency femtosecond laser cataract', 'low pulse energy femtosecond laser-assisted cataract surgery', 'ketorolac', 'randomized low-energy femtosecond laser pretreatment in 1 eye and conventional phacoemulsification', 'femtosecond laser pretreatment and before conventional phacoemulsification']","['levels of 1β, IL-6, or total PG and suction time or lens density', 'Mean concentrations of IL-1β, IL-6, and total PG', 'Levels of IL-1β and IL-6', 'PG release', 'PG levels', 'interleukin (IL)-1β, IL-6, and total prostaglandin (PG) levels', 'IL-1β, IL-6, and total PG (including PGE1, PGE2; PGF1a, PGF2a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1266240', 'cui_str': 'Prostaglandin measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1266240', 'cui_str': 'Prostaglandin measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0012471', 'cui_str': 'Dinoprost'}]",40.0,0.0724059,"Mean concentrations of IL-1β, IL-6, and total PG were 0.87, 0.67, and 32.19 pg/mL in the femto group compared with 0.10 (P = .36), 0.78","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'From the Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': ''}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000221']
1810,32818720,A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors.,"OBJECTIVE


Interventions for fear of recurrence (FOR) of cancer have nominal effects, perhaps due to limited integration of empirically supported skills. This pilot trial tested the acceptability and feasibility of a multimodal, mind-body resiliency intervention targeting FOR among survivors of various cancers.
METHODS


Early stage cancer survivors 3-30 months post-treatment were recruited to participate in an eight-session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR. Primary outcomes were feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance). Patient-reported outcomes (FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills) were collected at baseline, post-intervention, +1 month, and +3 months. Exit interviews assessed survivors' reported benefits.
RESULTS


Participants (N = 4 groups, 23 survivors, enrollment response rate = 58%) included survivors of seven common cancer types who were on average 12 months post-treatment. Attendance was high (M = 6.1 sessions), and 96% of survivors completed all surveys. Sustained increases in relaxation skills practice 3+ days/week were reported (baseline = 16%, post-intervention = 76%, +3 months = 71%). Most sessions (87%) were rated as highly or very highly acceptable. Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes. Exit interviews revealed behavioral, cognitive, emotional, and existential benefits.
CONCLUSIONS


The targeted mind-body resiliency intervention shows promising acceptability, feasibility, and favorable changes in FOR and coping skills practice. Further adaptation and testing in a randomized trial are warranted. ClinicalTrials.govRegistration Number: NCT03695406.",2020,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","['survivors of various cancers', 'Cancer Survivors', 'Early stage cancer survivors 330\xa0months post-treatment were recruited to participate in an eight']","['multimodal, mind-body resiliency intervention', 'session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR']","['FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills', 'behavioral, cognitive, emotional, and existential benefits', 'feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance', 'FOR severity', 'relaxation skills practice']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",,0.129392,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America. Electronic address: hall@mgh.harvard.edu.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110215']
1811,32818949,Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial.,"BACKGROUND


Intrauterine infection and/or inflammation (Triple I) is an important cause of preterm birth (PTB) and adverse newborn outcomes. N-acetylcysteine (NAC) is a Food and Drug Administration (FDA)-approved drug safely administered to pregnant women with acetaminophen toxicity.
METHODS


We conducted a single-center, quadruple-blind, placebo-controlled trial of pregnant women with impending PTB due to confirmed Triple I. Participants (n = 67) were randomized to an intravenous infusion of NAC or placebo mimicking the FDA-approved regimen. Outcomes included clinical measures and mechanistic biomarkers.
RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34). Fewer NAC-exposed newborns developed two or more prematurity-related severe morbidities [NAC: 21% vs. placebo: 47%, relative risk, 0.45; 95% confidence interval (CI) 0.21-0.95] with the strongest protection afforded against bronchopulmonary dysplasia (BPD, NAC: 3% vs. placebo: 32%, relative risk, 0.10; 95% CI: 0.01-0.73). These effects were independent of gestational age, birth weight, sex, or race. Umbilical cord plasma NAC concentration correlated directly with cysteine, but not with plasma or whole blood glutathione. NAC reduced the placental expression of histone deacetylase-2, suggesting that epigenetic mechanisms may be involved.
CONCLUSIONS


These data provide support for larger studies of intrapartum NAC to reduce prematurity-related morbidity.
IMPACT


In this randomized clinical trial of 65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight. Administration of NAC in amniocentesis-confirmed Triple I resulted in a remarkably lower incidence of BPD. As prior studies have not shown a benefit of postnatal NAC in ventilated infants, our trial highlights the critical antenatal timing of NAC administration. Repurposing of NAC for intrapartum administration should be explored in larger clinical trials as a strategy to improve prematurity-related outcomes and decrease the incidence of BPD.",2020,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","['premature infants with intra-amniotic infection and inflammation (Triple I', '65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight', 'pregnant women with impending PTB due to confirmed Triple I. Participants (n\u2009=\u200967', 'women with idiopathic preterm birth (iPTB, a, b) absent', 'Thirteen patients who were ineligible for the trial based on negative assessment for Triple I contributed placental samples as reference for immunohistochemistry experiments', 'pregnant women with acetaminophen toxicity']","['NAC or placebo', 'Antenatal N-acetylcysteine', 'N-acetylcysteine (NAC', 'placebo (c, d) or N-acetylcysteine infusion (e, f', 'Triple I or PTB', 'NAC', 'immunohistochemical staining for histone deacetylase-2 (HDAC2', 'placebo']","['status at birth and required less intensive resuscitation', 'Umbilical cord plasma NAC concentration', 'BPD', 'clinical measures and mechanistic biomarkers', 'placental expression of histone deacetylase-2', 'prematurity-related severe morbidities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0237963', 'cui_str': 'Poisoning caused by acetaminophen'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0404413', 'cui_str': 'Placental expression'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",65.0,0.55222,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","[{'ForeName': 'Catalin S', 'Initials': 'CS', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA. csb01@uic.edu.'}, {'ForeName': 'Mert Ozan', 'Initials': 'MO', 'LastName': 'Bahtiyar', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Guomao', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Abdelghany', 'Affiliation': 'Clinical Department of Pharmacy, Yale New Haven Hospital, New Haven, CT, 06510, USA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Sonya Abdel', 'Initials': 'SA', 'LastName': 'Razeq', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Antonette T', 'Initials': 'AT', 'LastName': 'Dulay', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Lipkind', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Saya', 'Initials': 'S', 'LastName': 'Mieth', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Bhandari', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}]",Pediatric research,['10.1038/s41390-020-01106-w']
1812,32818953,Navigation aid for blind persons by visual-to-auditory sensory substitution: A pilot study.,"PURPOSE


In this study, we investigate to what degree augmented reality technology can be used to create and evaluate a visual-to-auditory sensory substitution device to improve the performance of blind persons in navigation and recognition tasks.
METHODS


A sensory substitution algorithm that translates 3D visual information into audio feedback was designed. This algorithm was integrated in an augmented reality based mobile phone application. Using the mobile device as sensory substitution device, a study with blind participants (n = 7) was performed. The participants navigated through pseudo-randomized obstacle courses using either the sensory substitution device, a white cane or a combination of both. In a second task, virtual 3D objects and structures had to be identified by the participants using the same sensory substitution device.
RESULTS


The realized application for mobile devices enabled participants to complete the navigation and object recognition tasks in an experimental environment already within the first trials without previous training. This demonstrates the general feasibility and low entry barrier of the designed sensory substitution algorithm. In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.",2020,"In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.",[],"['visual-to-auditory sensory substitution', 'sensory substitution device, a white cane or a combination of both']",['navigation'],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006856', 'cui_str': 'Cane'}]",[],,0.0374328,"In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Neugebauer', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rifai', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Getzlaff', 'Affiliation': 'Institute for Applied Physics, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Wahl', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0237344']
1813,32819321,Pain trajectories of dorsomedial prefrontal intermittent theta burst stimulation versus sham treatment in depression.,"BACKGROUND


Prefrontal repetitive transcranial magnetic stimulation is an established add-on treatment for major depressive disorder and is increasingly feasible with protocols of short duration, such as intermittent theta burst stimulation (iTBS). The most common and limiting side effect is pain at the site of application. Our objective was to investigate how pain develops over time in patients with depression receiving iTBS compared to sham stimulation.
METHODS


This is a subsample from a randomized clinical trial. Patients received daily sessions of 2400 pulses of dorsomedial prefrontal iTBS or sham stimulation with transcutaneous electric stimulation during 2 to 3 weeks. After unmasking of treatment allocation, patients receiving sham treatment were offered active iTBS in an open phase. Patients rated pain on a scale from 0 to 10 after the last train of stimulation on the first, fifth and final treatment day. A Mann-Whitney U-test was conducted to test for group differences and related-samples Friedman's tests to analyze changes in pain ratings over time.
RESULTS


The scalp pain in the group receiving iTBS was rated higher than sham treatment on the first (U = 263.5, p = 0.035) and fifth day (U = 271.0, p = 0.020) but not on the final day (U = 210.5, p = 0.121). The pain decreased mainly during the first 5 days of treatment (χ 2  = 0.875, p = 0.040). In the open phase the pain decreased from the first day to the final day (χ 2  = 1.194, p = 0.001).
CONCLUSIONS


The subjective pain perception of active dorsomedial iTBS was higher than sham treatment but decreased over time, indicating an analgesic effect, or habituation. The result from this study can be used to inform patients about what to expect regarding pain during an iTBS treatment course.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02905604 . Registered 19 September 2016.",2020,"The pain decreased mainly during the first 5 days of treatment (χ 2  = 0.875, p = 0.040).",['patients with depression receiving'],"['iTBS', 'daily sessions of 2400 pulses of dorsomedial prefrontal iTBS or sham stimulation with transcutaneous electric stimulation', 'dorsomedial prefrontal intermittent theta burst stimulation']","['analgesic effect, or habituation', 'active iTBS', 'Pain trajectories', 'subjective pain perception of active dorsomedial iTBS', 'pain', 'pain ratings', 'scalp pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0240940', 'cui_str': 'Scalp pain'}]",,0.10188,"The pain decreased mainly during the first 5 days of treatment (χ 2  = 0.875, p = 0.040).","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Malm', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden. robert.boden@neuro.uu.se.'}]",BMC neurology,['10.1186/s12883-020-01881-3']
1814,32819350,"Intellectual disability, exercise and aging: the IDEA study: study protocol for a randomized controlled trial.","BACKGROUND


People with intellectual disabilities (ID) have low levels of physical activity (PA) together with accelerated aging profiles. Adherence to PA interventions for persons with ID is low based on barriers such as motivation. The IDEA study aims to determine the effect of two types of exercise programs, continuous aerobic (CAEP) vs sprint interval training (SIT), designed for seniors with ID on health-related physical fitness, cardiovascular parameters, quality of life (QoL), and emotional and cognitive function.
METHODS


In this trial, ninety seniors with ID between the ages of 40 and 75 yrs. from occupational health centers from the Autonomous Region of Catalonia (Spain) will be recruited. Participants will be randomly allocated to the CAEP, SIT, and control group. Both intervention groups will train 3 days/week, 1.5 h/day over 6 months. Outcome variables will be assessed at baseline, 6 months and 12 months. The outcome variables include weight, height, body composition, cardiorespiratory fitness, muscle strength, balance, flexibility, cardiovascular parameters (blood pressure, pulse-wave velocity, pulse-wave analysis), QoL and cognitive function. The intervention effect will be determined with mixed models with repeated measures to assess changes in the outcome variables over time (baseline to month 12) and between study arms. Relationship between variables will be analyzed with appropriate regression analyses.
DISCUSSION


Various studies reported on CAEP and SIT as exercise interventions for persons with ID with beneficial outcomes on body composition, fitness and blood pressure. To our knowledge, this is the first trial designed to analyse the positive changes on fitness, PA levels, cardiovascular, QoL and cognitive function promoted by CAEP training and SIT in seniors with ID. The findings of this study will assist in the development of more effective exercise interventions to ensure better compliance and adherence to exercise in seniors with ID.
TRIAL REGISTRATION


The trial is registered at the ISRCTN registry. Registration number: ISRCTN43594228 . Registered 11 February 2019 - Retrospectively registered.",2020,"Various studies reported on CAEP and SIT as exercise interventions for persons with ID with beneficial outcomes on body composition, fitness and blood pressure.","['People with intellectual disabilities (ID', 'seniors with ID on health-related', 'seniors with ID', 'from occupational health centers from the Autonomous Region of Catalonia (Spain', 'Registered 11 February 2019 - Retrospectively registered', 'persons with ID', 'ninety seniors with ID between the ages of 40 and 75\u2009yrs']","['exercise programs, continuous aerobic (CAEP) vs sprint interval training (SIT', 'CAEP, SIT, and control group']","['physical fitness, cardiovascular parameters, quality of life (QoL), and emotional and cognitive function', 'fitness, PA levels, cardiovascular, QoL and cognitive function', 'weight, height, body composition, cardiorespiratory fitness, muscle strength, balance, flexibility, cardiovascular parameters (blood pressure, pulse-wave velocity, pulse-wave analysis), QoL and cognitive function', 'body composition, fitness and blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}]",90.0,0.0951115,"Various studies reported on CAEP and SIT as exercise interventions for persons with ID with beneficial outcomes on body composition, fitness and blood pressure.","[{'ForeName': 'Guillermo R', 'Initials': 'GR', 'LastName': 'Oviedo', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain. guillermorubeno@blanqnuerna.url.edu.'}, {'ForeName': 'Casimiro', 'Initials': 'C', 'LastName': 'Javierre', 'Affiliation': 'Department of Physiological Sciences, School of Medicine, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Font-Farré', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Nauris', 'Initials': 'N', 'LastName': 'Tamulevicius', 'Affiliation': 'Department of Health Sciences and Human Performance, College of Natural and Health Sciences, The University of Tampa, Tampa, Florida, USA.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Carbó-Carreté', 'Affiliation': 'Faculty of Psychology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Pérez-Testor', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Cabedo-Sanromá', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Moss', 'Affiliation': 'Physical Activity, Sport and Recreation Research Focus Area, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Massó-Ortigosa', 'Affiliation': 'School of Health Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Guerra-Balic', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}]",BMC public health,['10.1186/s12889-020-09353-6']
1815,32819352,A randomised controlled trial of feedback to improve patient satisfaction and consultation skills in medical students.,"BACKGROUND


The use of feedback has been integral to medical student learning, but rigorous evidence to evaluate its education effect is limited, especially in the role of patient feedback in clinical teaching and practice improvement. The aim of the Patient Teaching Associate (PTA) Feedback Study was to evaluate whether additional written consumer feedback on patient satisfaction improved consultation skills among medical students and whether multisource feedback (MSF) improved student performance.
METHODS


In this single site, double-blinded randomised controlled trial, 71 eligible medical students from two universities in their first clinical year were allocated to intervention or control and followed up for one semester. They participated in five simulated student-led consultations in a teaching clinic with patient volunteers living with chronic illness. Students in the intervention group received additional written feedback on patient satisfaction combined with guided self-reflection. The control group received usual immediate formative multisource feedback from tutors, patients and peers. Student characteristics, baseline patient-rated satisfaction scores and tutor-rated consultation skills were measured.
RESULTS


Follow-up assessments were complete in 70 students attending the MSF program. At the final consultation episodes, both groups improved patient-rated rapport (P = 0.002), tutor-rated patient-centeredness and tutor-rated overall consultation skills (P = 0.01). The intervention group showed significantly better tutor-rated patient-centeredness (P = 0.003) comparing with the control group. Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills did not differ significantly between the two groups.
CONCLUSIONS


The innovative multisource feedback program effectively improved consultation skills in medical students. Structured written consumer feedback combined with guided student reflection further improved patient-centred practice and effectively enhanced the benefit of an MSF model. This strategy might provide a valuable adjunct to communication skills education for medical students.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry Number ACTRN12613001055796 .",2020,"Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills did not differ significantly between the two groups.
","['71 eligible medical students from two universities in their first clinical year', 'patient volunteers living with chronic illness', 'medical students', '70 students attending the MSF program']","['additional written feedback on patient satisfaction combined with guided self-reflection', 'usual immediate formative multisource feedback']","['patient-rated rapport', 'consultation skills', 'Student characteristics, baseline patient-rated satisfaction scores and tutor-rated consultation skills', 'Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills', 'tutor-rated patient-centeredness and tutor-rated overall consultation skills', 'patient satisfaction and consultation skills', 'better tutor-rated patient-centeredness']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",71.0,0.167151,"Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills did not differ significantly between the two groups.
","[{'ForeName': 'Michelle M Y', 'Initials': 'MMY', 'LastName': 'Lai', 'Affiliation': 'Medical Student Programs, Eastern Health Clinical School, Monash University and Deakin University, Level 2, Arnold Street, Box Hill, VIC, 3128, Australia. michelle.m.lai@curtin.edu.au.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Medical Student Programs, Eastern Health Clinical School, Monash University and Deakin University, Level 2, Arnold Street, Box Hill, VIC, 3128, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Jenepher', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Medical Student Programs, Eastern Health Clinical School, Monash University and Deakin University, Level 2, Arnold Street, Box Hill, VIC, 3128, Australia.'}]",BMC medical education,['10.1186/s12909-020-02171-9']
1816,32819404,Evaluation of the analgesic effect of vertebral cancellous bone infiltration anaesthesia during vertebroplasty.,"OBJECTIVE


To evaluate the analgesic effect of vertebral cancellous bone infiltration anaesthesia during percutaneous vertebroplasty (PVP).
METHODS


Patients treated with vertebral cancellous bone infiltration anaesthesia (intervention group) or local anaesthesia alone (control group) during PVP at our institution during 2016-2018 were reviewed. The visual analogue scale (VAS) score before the operation, during establishment of the puncture channel, during pressure changes in the vertebral body (e.g., when removing or inserting pushers or needle cores), during bone cement injection, immediately after the operation, and at 2 h and 1 day postoperatively were compared between the groups. The patient's satisfaction with the operation was recorded and compared between groups.
RESULTS


A total of 112 patients were enrolled (59 cases in the intervention group and 53 cases in the control group). There was no difference in the VAS score between the groups before the operation or during establishment of the intraoperative puncture channel (P > 0.05). The VAS score in the intervention group was significantly lower than that in the control group during pressure changes in the vertebral body (removal or insertion of puncture needle cores or pushers) and bone cement injection (P < 0.05). Immediately after the operation and at 2 h postoperatively, the pain in the intervention group was also significantly lower than that in the control group (P < 0.05), but there was no significant difference between the groups at 1 day postoperatively (P > 0.05). The patient satisfaction rate was 88% (52/59) in the intervention group and 67% (35/53) in the control group (P < 0.05).
CONCLUSIONS


Vertebral cancellous bone infiltration anaesthesia may effectively relieve intraoperative pain and improve the surgical experience of patients without affecting the clinical effect of surgery.",2020,The VAS score in the intervention group was significantly lower than that in the control group during pressure changes in the vertebral body (removal or insertion of puncture needle cores or pushers) and bone cement injection (P < 0.05).,"['at our institution during 2016-2018 were reviewed', '112 patients were enrolled (59 cases in the intervention group and 53 cases in the control group', 'Patients treated with vertebral cancellous bone infiltration anaesthesia (intervention group) or']","['vertebral cancellous bone infiltration anaesthesia during percutaneous vertebroplasty (PVP', 'vertebral cancellous bone infiltration anaesthesia', 'local anaesthesia alone (control group) during PVP']","['VAS score', 'patient satisfaction rate', 'intraoperative pain', 'pain', 'visual analogue scale (VAS) score']","[{'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}]","[{'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",112.0,0.0189299,The VAS score in the intervention group was significantly lower than that in the control group during pressure changes in the vertebral body (removal or insertion of puncture needle cores or pushers) and bone cement injection (P < 0.05).,"[{'ForeName': 'Zhaofei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China. hanyangzzf@163.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiao', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Fengwei', 'Initials': 'F', 'LastName': 'Qin', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Sineng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Donghua', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01872-7']
1817,32819412,Virtual reality-based action observation facilitates the acquisition of body-powered prosthetic control skills.,"BACKGROUND


Regular body-powered (BP) prosthesis training facilitates the acquisition of skills through repeated practice but requires adequate time and motivation. Therefore, auxiliary tools such as indirect training may improve the training experience and speed of skill acquisition. In this study, we examined the effects of action observation (AO) using virtual reality (VR) as an auxiliary tool. We used two modalities during AO: three-dimensional (3D) VR and two-dimensional (2D) computer tablet devices (Tablet). Each modality was tested from first- and third-person perspectives.
METHODS


We studied 40 healthy right-handed participants wearing a BP prosthesis simulator on their non-dominant hands. The participants were divided into five groups based on combinations of the different modalities and perspectives: first-person perspective on VR (VR1), third-person perspective on VR (VR3), first-person perspective on a tablet (Tablet1), third-person perspective on a tablet (Tablet3), and a control group (Control). The intervention groups observed and imitated the video image of prosthesis operation for 10 min in each of two sessions. We evaluated the level of immersion during AO using the visual analogue scale. Prosthetic control skills were evaluated using the Box and Block Test (BBT) and a bowknot task (BKT).
RESULTS


In the BBT, there were no significant differences in the amount of change in the skills between the five groups. In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group. Additionally, the immersion scores of VR1 (p < 0.05, d = 1.45) and VR3 (p < 0.05, d = 1.18) were higher than those of Tablet3. There was a significant negative correlation between the immersion scores and the relative change in the BKT scores (Spearman's r s  = - 0.47, p < 0.01).
CONCLUSIONS


Using the BKT of bilateral manual dexterity, VR-based AO significantly improved short-term prosthetic control acquisition. Additionally, it appeared that the higher the immersion score was, the shorter the execution time of the BKT task. Our findings suggest that VR-based AO training may be effective in acquiring bilateral BP prosthetic control, which requires more 3D-based operation.",2020,"In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group.",['40 healthy right-handed participants wearing a BP prosthesis simulator on their non-dominant hands'],"['person perspective on VR (VR1), third-person perspective on VR (VR3), first-person perspective on a tablet (Tablet1), third-person perspective on a tablet (Tablet3), and a control group (Control', 'Regular body-powered (BP) prosthesis training', 'AO: three-dimensional (3D) VR and two-dimensional (2D) computer tablet devices (Tablet', 'Virtual reality-based action observation', 'VR-based AO training', 'action observation (AO) using virtual reality (VR']","['Box and Block Test (BBT) and a bowknot task (BKT', 'execution time of the BKT task', 'immersion scores of VR1', 'VR3', 'BKT scores']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0170855,"In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group.","[{'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Yoshimura', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan. mnb328@med.kawasaki-m.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kurumadani', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Osaka', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Katsutoshi', 'Initials': 'K', 'LastName': 'Senoo', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Date', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ueda', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Ishii', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Kawasaki Medical School Hospital, Okayama, Japan, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Hanayama', 'Affiliation': 'Kawasaki Medical School, Department of Rehabilitation Medicine, Okayama, Japan, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sunagawa', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00743-w']
1818,32819413,Impact of a ketogenic diet intervention during radiotherapy on body composition: III-final results of the KETOCOMP study for breast cancer patients.,"BACKGROUND


Obesity and low muscle mass are associated with worse outcomes of breast cancer patients. We conducted a controlled trial to study the impact of a ketogenic diet (KD) based on natural foods versus an unspecified standard diet (SD) on body composition in breast cancer patients undergoing radiotherapy.
METHODS


Patients with non-metastasized breast cancer were allocated to either the KD (N = 32) or the SD (N = 31) during radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters and quality of life were assessed before, during, and at the end of radiotherapy.
RESULTS


A total of 29 KD and 30 SD patients completed the study. During radiotherapy, mean and median fasting BHB concentrations in the KD group were 0.72 and 0.49 mmol/l (range 0.06-4.9) which was significantly higher than those in the SD group (p < 2.2 × 10 -16 ). There was a very small and insignificant increase in body weight and fat mass in the SD group, as well as a decrease of fat free mass. In contrast, patients in the KD group lost body weight and fat free and skeletal muscle mass quickly after diet onset, which for the most part was related to water losses. The KD did not cause further substantial changes in fat free or skeletal muscle mass, but was associated with a gradual decrease of 0.4 kg body weight and fat mass per week (p < 0.0001). The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ). Global quality of life remained stable in the SD group but increased in the KD group from a score of 66.7 to 75.0 (p = 0.20).
CONCLUSIONS


In breast cancer patients undergoing curative radiotherapy, a KD based on natural foods is feasible. After initial water losses, the KD tends to reduce body weight and fat mass while preserving fat free and skeletal muscle mass.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02516501 , registered on August 06, 2015.",2020,The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ).,"['breast cancer patients undergoing', 'Patients with non-metastasized breast cancer', 'breast cancer patients', 'breast cancer patients undergoing radiotherapy', 'A total of 29 KD and 30 SD patients completed the study']","['ketogenic diet intervention', 'ketogenic diet (KD) based on natural foods versus an unspecified standard diet (SD', 'radiotherapy', 'curative radiotherapy']","['fat free or skeletal muscle mass', 'Body composition', 'body composition', 'Blood parameters and quality of life', 'free T3 levels', 'body weight and fat free and skeletal muscle mass', 'mean and median fasting BHB concentrations', 'Global quality of life', 'body weight and fat mass']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0519160', 'cui_str': 'Triiodothyronine, free measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0482809,The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ).,"[{'ForeName': 'Rainer J', 'Initials': 'RJ', 'LastName': 'Klement', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany. rainer_klement@gmx.de.'}, {'ForeName': 'Colin E', 'Initials': 'CE', 'LastName': 'Champ', 'Affiliation': 'Department of Radiation Oncology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Kämmerer', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Petra S', 'Initials': 'PS', 'LastName': 'Koebrunner', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Krage', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Schäfer', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weigel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leopoldina Hospital, Breast Cancer Centre, Schweinfurt, Germany.'}, {'ForeName': 'Reinhart A', 'Initials': 'RA', 'LastName': 'Sweeney', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01331-5']
1819,32819429,"The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design.","BACKGROUND


The diagnostic accuracy of CT-derived fractional flow reserve (CT-FFR) in clinical application has been well validated. This advanced technology focus on evaluating anatomical stenosis and functional ischemia simultaneously. However, the effect of CT-FFR on the management of decision making has not been fully evaluated in randomized controlled design.
METHOD/DESIGN


TARGET study is a pragmatic, multicenter, prospective, open-label, and randomized controlled trial evaluating the effect of a CCTA/CT-FFR strategy (group A) versus usual care (group B) on intermediate-to-high risk patients with suspected CAD who undergo clinically indicated diagnostic evaluation. A total sample size of 1216 subjects will be enrolled and followed up for 12 months. This study will be performed in 6 Chinese hospitals, and the primary endpoint is the planned ICA without significant obstructive CAD within 90 days. The secondary endpoints include MACE, quality of life, medical expenditure, and cumulative radiation exposure during 1-year follow-up.
DISCUSSION


The study will provide information to patients, health care providers, and other stakeholders in China about which strategy could be more effective in the management of intermediate-to-high risk patients with suspect CAD.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03901326 . Registered on 3 April 2019.",2020,"BACKGROUND


The diagnostic accuracy of CT-derived fractional flow reserve (CT-FFR) in clinical application has been well validated.","['risk patients with suspected CAD who undergo clinically indicated diagnostic evaluation', '6 Chinese hospitals', 'A total sample size of 1216 subjects will be enrolled and followed up for 12\u2009months', 'patients with stable chest pain (TARGET trial']","['CCTA/CT-FFR strategy (group A) versus usual care', 'CT-FFR', 'site CT-derived fractional flow reserve', 'CT-derived fractional flow reserve (CT-FFR']","['MACE, quality of life, medical expenditure, and cumulative radiation exposure during 1-year follow-up']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1216.0,0.121725,"BACKGROUND


The diagnostic accuracy of CT-derived fractional flow reserve (CT-FFR) in clinical application has been well validated.","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Rd, Haidian District, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Dongkai', 'Initials': 'D', 'LastName': 'Shan', 'Affiliation': ""Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Rd, Haidian District, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, Qilu Hospital of Shandong University, Jinan, People's Republic of China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumchi, People's Republic of China.""}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Hesong', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': ""Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Rd, Haidian District, Beijing, 100853, People's Republic of China. cyundai@vip.163.com.""}]",Trials,['10.1186/s13063-020-04649-9']
1820,32819447,"Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk.","BACKGROUND


Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM).
METHODS


This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10 -5  sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk.
RESULTS


After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR.
CONCLUSION


These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.",2020,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","['patients with relapsed or refractory MM (RRMM', 'Multiple myeloma (MM) patients with high cytogenetic risk']","['Daratumumab, bortezomib, and dexamethasone', 'bortezomib/dexamethasone (Vd) alone', 'bortezomib/dexamethasone']","['progression-free survival (PFS', 'higher rates of MRD negativity and sustained MRD negativity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",498.0,0.142329,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. k.weisel@uke.de.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lentzsch', 'Affiliation': 'Division of Hematology/Oncology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unite de Genomique du Myelome, CHU Rangueil, Toulouse, France.'}, {'ForeName': 'Tomer M', 'Initials': 'TM', 'LastName': 'Mark', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': 'Clinical Department of Haematology, 1st Medical Department, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'László Hospital, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Lauri', 'Affiliation': 'Department of Hematology, Sunderbyn Hospital, Luleå, Sweden.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bosi', 'Affiliation': 'Department of Hematology, Careggi Hospital and University of Florence, Firenze, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Irmandade Da Santa Casa De Misericordia De São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': '""Seràgnoli"" Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Je-Jung', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, South Korea.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nooka', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'University Medical Center of the Johannes Gutenberg University, Third Department of Medicine, Mainz, Germany.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Wolney', 'Initials': 'W', 'LastName': 'Barreto', 'Affiliation': 'University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Milan, Italy.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Asher A', 'Initials': 'AA', 'LastName': 'Chanan-Khan', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Horvath', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': 'Instituto do Cancer-Hospital Mae de Deus, Porto Alegre, Brazil.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ovilla', 'Affiliation': 'Hospital Angeles Lomas, Naucalpan de Juárez y alrededores, Mexico.'}, {'ForeName': 'Jae-Cheol', 'Initials': 'JC', 'LastName': 'Jo', 'Affiliation': 'Ulsan University Hospital, Ulsan, South Korea.'}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'Casneuf', 'Affiliation': 'Janssen Research & Development, LLC, Beerse, Belgium.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'DeAngelis', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Amin', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00948-5']
1821,32819928,ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.,"INTRODUCTION


Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
METHODS AND ANALYSIS


We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent-child interactions to improve early social reciprocity, while supporting parental mental health and the parent-child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent-infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs.
ETHICS AND DISSEMINATION


This protocol has been approved by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).",2020,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","['infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD', 'infants at risk of autism spectrum disorder', 'Autism spectrum disorder (ASD', '66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT']","['ENACT (ENvironmental enrichment', 'innovative intervention', 'ENACT', 'social reciprocity intervention']","['parent-infant interaction, parental mental health, infant development and early ASD markers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.264507,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","[{'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia koawhittingham@uq.edu.au.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McGlade', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kavindri', 'Initials': 'K', 'LastName': 'Kulasinghe', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mitchell', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Honey', 'Initials': 'H', 'LastName': 'Heussler', 'Affiliation': 'Mater Medical Research Institute, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034315']
1822,32819929,"Multiple-dose tranexamic acid for perioperative blood loss in total knee arthroplasty in patients with rheumatoid arthritis：a single-blinded, randomised, parallel-controlled study protocol in China.","INTRODUCTION


This clinical trial is designed to evaluate the effect of multiple-dose tranexamic acid (TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA).
METHODS AND ANALYSIS


A randomised, single-blinded, parallel-controlled study will be designed. Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery. The primary outcomes will be evaluated with blood loss, maximum haemoglobin drop and transfusion rate. The secondary outcomes will be evaluated with knee function and complications.
ETHICS AND DISSEMINATION


The Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine Ethics Committee approved in this study in July 2019. Informed consent will be obtained from all participants. Results of the trial will be published in the Dryad and repository in a peer-reviewed journal. Additionally, deidentified data collected and analysed for this study will be available for review from the corresponding author on reasonable request.
TRIAL REGISTRATION NUMBER


ChiCTR1900025013.",2020,"Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery.","['patients with rheumatoid arthritis (RA', 'Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty', 'total knee arthroplasty in patients with rheumatoid arthritis：a single-blinded']","['tranexamic acid (TXA', 'tranexamic acid', 'TXA']","['blood loss, maximum haemoglobin drop and transfusion rate', 'knee function and complications', 'perioperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.222455,"Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery.","[{'ForeName': 'Bing-Xin', 'Initials': 'BX', 'LastName': 'Kang', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chen-Xin', 'Initials': 'CX', 'LastName': 'Gao', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Song-Tao', 'Initials': 'ST', 'LastName': 'Sun', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ying-Hui', 'Initials': 'YH', 'LastName': 'Ma', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei-Tao', 'Initials': 'WT', 'LastName': 'Zhai', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lian-Bo', 'Initials': 'LB', 'LastName': 'Xiao', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China 13701888178@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034431']
1823,32819927,"Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).","OBJECTIVES


To compare the effectiveness of oral versus intramuscular (IM) vitamin B 12  (VB12) in patients aged ≥65 years with VB12 deficiency.
DESIGN


Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain).
PARTICIPANTS


283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm.
INTERVENTIONS


The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52.
MAIN OUTCOMES


Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction.
RESULTS


The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B 12  levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B 12  levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route.
CONCLUSIONS


Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.
TRIAL REGISTRATION NUMBERS


NCT01476007; EUDRACT (2010-024129-20).",2020,(133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis.,"['patients aged ≥65 years with VB12 deficiency', '22 primary healthcare centres in Madrid (Spain', '283 patients ≥65 years with VB12 deficiency']","['vitamin B12', 'oral versus intramuscular (IM) vitamin B 12  (VB12']","['normal B 12  levels', 'Quality of life and adverse effects', 'Serum VB12 concentration normalisation', 'symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction', 'success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4708786', 'cui_str': '283'}]","[{'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",22.0,0.335499,(133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanz-Cuesta', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Escortell-Mayor', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Cura-Gonzalez', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain isabel.cura@salud.madrid.org.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Martin-Fernandez', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Riesgo-Fuertes', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Garrido-Elustondo', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Jose Enrique', 'Initials': 'JE', 'LastName': 'Mariño-Suárez', 'Affiliation': 'Healthcare Centre El Greco, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Álvarez-Villalba', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gómez-Gascón', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'González-García', 'Affiliation': 'Healthcare Centre Barajas, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'González-Escobar', 'Affiliation': 'Healthcare Centre Buenos Aires, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Vargas-Machuca Cabañero', 'Affiliation': 'Healthcare Centre Guayaba, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Noguerol-Álvarez', 'Affiliation': 'Healthcare Centre Cuzco, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'García de Blas-González', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Baños-Morras', 'Affiliation': 'Healthcare Centre Buenos Aires, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Díaz-Laso', 'Affiliation': 'Healthcare Centre Fuentelarreina, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Caballero-Ramírez', 'Affiliation': 'Healthcare Centre Juncal, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Herrero de-Dios', 'Affiliation': 'Healthcare Centre Miguel de Cervantes, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Fernández-García', 'Affiliation': 'Healthcare Centre Santa Isabel, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Herrero-Hernández', 'Affiliation': 'Healthcare Centre Lavapiés, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Pose-García', 'Affiliation': 'Healthcare Centre Mendiguchía Carriche, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Sevillano-Palmero', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Mateo-Ruiz', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Medina-Bustillo', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Aguilar-Jiménez', 'Affiliation': 'UICEC Hospital Ramón y Cajal. Plataforma SCReN, Hospital Ramón y Cajal; Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033687']
1824,32819944,"Protocol of a multicenter, single-blind, randomised, parallel controlled feeding trial evaluating the effect of a Chinese Healthy Heart (CHH) diet in lowering blood pressure and other cardiovascular risk factors.","INTRODUCTION


Unhealthy diet has been identified as the number one attributor of total mortality in China, accounting for more than 20% of total deaths. Although the Dietary Approach to Stop Hypertension (DASH) and Mediterranean diets have been proven beneficial in managing cardiovascular risk factors in Western countries, whether healthy diets with similar cardiovascular benefits can be developed that are consistent with Chinese food culture remains unknown.
METHODS/DESIGN


The Diet, ExerCIse and CarDiovascular hEalth (DECIDE)-Diet trial is a multicentre, single-blind, randomised controlled feeding trial to evaluate the effect of the Chinese Healthy Heart (CHH) diet, in comparison with the Chinese usual diet, in lowering cardiovascular risk factors among community residents with the increased cardiovascular risk. A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu. After 1 week of run-in period with local usual diet, the compliant participants will be randomised to the intervention group with the CHH diet or the control group with the usual local diet, on a 1:1 ratio, for 4 weeks. Body weight of study participants will be maintained during the entire study period. The primary outcome is the change in SBP from the baseline to the end of the study. DECIDE-Diet trial will be the first randomised controlled feeding trial to evaluate the effect of a CHH diet in lowering cardiovascular risk factors. This trial will provide compelling evidence on the CHH diet in effect of improving cardiovascular health among Chinese food consumers all around the world.
ETHICS AND DISSEMINATION


This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Peking University Institutional Review Board (approval number: IRB00001052-18094). The results will be disseminated through academic conferences and publications in international peer-reviewed journals.
TRAIL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03882645); Pre-results.",2020,"A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu.","['community residents with the increased cardiovascular risk', '360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159\u2009mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu']","['Chinese Healthy Heart (CHH) diet', 'CHH diet or the control group with the usual local diet', 'CHH diet']","['blood pressure and other cardiovascular risk factors', 'change in SBP', 'Diet, ExerCIse and CarDiovascular hEalth']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",360.0,0.111837,"A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu.","[{'ForeName': 'Wuxiang', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China pucri_wangyf1225@bjmu.edu.cn.'}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Clinical Nutrition Center, Huadong Hospital affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Nutrition, Food Safety and Toxicology, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Huilian', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhenquan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'College of Tourism and Culinary Science, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, China CDC, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Nephrology Division, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Society of Health Risk Assessment & Control, Chinese Preventive Medicine Association, Beijing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, China CDC, Beijing, China.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Food Safety Risk Assessment of Ministry of Health, National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-036394']
1825,32819949,Comparing two dry needling interventions for plantar heel pain: a randomised controlled trial.,"OBJECTIVES


To compare the effectiveness of dry needling (DN) versus percutaneous needle electrolysis (PNE) for improving the level of pain, function and quality of life (QoL) of patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points.
DESIGN


A prospective, parallel-group, randomised controlled trial with blinded outcome assessment.
SETTING


A single treatment facility in the State of Kuwait.
PARTICIPANTS


118 participants were screened for eligibility. Of these, 102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial.
INTERVENTIONS


Two parallel groups, one study arm received DN and a stretching protocol whereas the other arm received percutaneous needling electrolysis with a stretching protocol.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome measure was the Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains. Secondary outcome measures included the 0-10 numerical rating scale pain visual analogue scale (VAS) scores, performed before and after each treatment session. In addition, QoL was measured using the EuroQoL-5 dimensions. All measurements were taken at baseline, at 4, 8, 12, 26 and 52 weeks.
RESULTS


Foot Pain domain improved at all time points for DN group (p<0.001; 29.7 (17.8 to 41.5)) and percutaneous needling electrolysis group (p<0.001; 32.7 (18.3 to 47.0)), without significant differences between groups. Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6 (-4.0 to -1.2)) and percutaneous needling electrolysis group (p<0.001; -3.0 (-4.5 to -1.6)). QoL improved at 4 weeks for both DN (p<0.01; 0.15 (0.5 to 0.25)) and percutaneous needling electrolysis group (p<0.01; 0.09 (0.01 to 0.17)) and at 8 and 52 weeks for the PNE group (p<0.01; 0.10 (0.02 to 0.18)), with significant differences between groups for the QoL at 52 weeks (p<0.05; 0.10 (0.01 to 0.18)). There were two small haematomas in the PNE group and one in the DN group. No serious adverse events were reported.
CONCLUSIONS


Both PNE and DN were effective for PHP management, reducing mean and maximum pain since the first treatment session, with long lasting effects (52 weeks) and significant differences between groups in the case of QoL at 52 weeks in favour of the PNE group.
TRIAL REGISTRATION NUMBER


NCT03236779.",2020,Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6,"['patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points', 'A single treatment facility in the State of Kuwait', '118 participants were screened for eligibility', 'plantar heel pain', '102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial']","['percutaneous needling electrolysis with a stretching protocol', 'percutaneous needling electrolysis', 'dry needling (DN) versus percutaneous needle electrolysis (PNE', 'dry needling interventions', 'DN and a stretching protocol']","['QoL', 'Pain VAS scores', 'level of pain, function and quality of life (QoL', '0-10 numerical rating scale pain visual analogue scale (VAS) scores', 'serious adverse events', 'Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains', 'Foot Pain domain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",118.0,0.160401,Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6,"[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Boloushi', 'Affiliation': 'Fisiatría y Enfermería, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Fisiatría y Enfermería, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Arian', 'Affiliation': 'Physical Therapy, Kuwait Ministry of Health, Safat, Kuwait.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain pherrero@usj.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Bellosta-López', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-038033']
1826,32819960,Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2).,"INTRODUCTION


Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.
METHODS AND ANALYSIS


A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.
ETHICS AND DISSEMINATION


This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.
TRIAL REGISTRATION NUMBER


ISRCTN14736486.",2020,The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design).,"['Patients with current LBP and no indicators of serious spinal pathology', 'primary care', 'primary care patients', 'patients with low back pain (LBP', 'Participants undergo a secondary screen for possible serious spinal pathology']","[""SupportBack' internet intervention, with or without physiotherapist telephone support"", 'internet intervention', 'usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support']","['pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis', 'physical function (using the Roland and Morris Disability Questionnaire', 'LBP-related disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332149', 'cui_str': 'Possible'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",,0.160252,The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design).,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK A.W.Geraghty@soton.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Department of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Keele Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, Keele, Newcastle, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Webley', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Durcan', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Alannah', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bathers', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Butler-Walley', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wathall', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Mansell', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Leigh', 'Affiliation': 'Patient and Public Involvement Representative, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040543']
1827,32819979,Prognostic value of 12 novel cardiological biomarkers in stable coronary artery disease. A 10-year follow-up of the placebo group of the Copenhagen CLARICOR trial.,"OBJECTIVE


To assess if 12 novel circulating biomarkers, when added to 'standard predictors' available in general practice, could improve the 10-year prediction of cardiovascular events and mortality in patients with stable coronary heart disease.
DESIGN


The patients participated as placebo receiving patients in the randomised clarithromycin for patients with stable coronary artery disease (CLARICOR) trial at a random time in their disease trajectory.
SETTING


Five Copenhagen University cardiology departments and a coordinating centre.
PARTICIPANTS


1998 participants with stable coronary artery disease.
OUTCOMES


Death and composite of myocardial infarction, unstable angina pectoris, cerebrovascular disease and death.
RESULTS


When only 'standard predictors' were included, 83.4% of all-cause death predictions and 68.4% of composite outcome predictions were correct. Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors. Adding the remaining 10 biomarkers (high-sensitive assay cardiac troponin T; neutrophil gelatinase-associated lipocalin; osteoprotegerin; N-terminal pro-B-type natriuretic peptide; tumour necrosis factor receptor 1 and 2; pregnancy-associated plasma protein A; endostatin; YKL40; cathepsin-B), which were all individually significantly associated with the prediction of the two outcomes, increased the figures to 84.7% and 69.7%.
CONCLUSION


When 'standard predictors' routinely available in general practices are used for risk assessment in consecutively sampled patients with stable coronary artery disease, the addition of 10 novel biomarkers to the prediction model improved the correct prediction of all-cause death and the composite outcome by <1.5%.
TRIAL REGISTRATION NUMBER


NCT00121550.",2020,"Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors.","['Five Copenhagen University cardiology departments and a coordinating centre', '1998 participants with stable coronary artery disease', 'patients with stable coronary heart disease', 'consecutively sampled patients with stable coronary artery disease', 'patients with stable coronary artery disease (CLARICOR) trial at a random time in their disease trajectory', 'stable coronary artery disease']","['log(cathepsin-S', 'clarithromycin', 'placebo']","['Death and composite of myocardial infarction, unstable angina pectoris, cerebrovascular disease and death']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587453', 'cui_str': 'Cardiology department'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}]",1998.0,0.0905681,"Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors.","[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark pwinkel@ctu.dk.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Section of Biostatistics, Department of Public Health Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'Cardiology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshopitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans Jørn', 'Initials': 'HJ', 'LastName': 'Kolmos', 'Affiliation': 'Department of Clinical Microbiology, Odense University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kasper Karmark', 'Initials': 'KK', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bjerre', 'Affiliation': 'The Medical Research Laboratory, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Family Medicine and Primary Care, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-033720']
1828,32819981,mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study.,"INTRODUCTION


Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.
METHODS AND ANALYSIS


In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.
ETHICS AND DISSEMINATION


The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03490253; pre-results.",2020,"In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression.","['low-income ethnic minority patients with comorbid diabetes and depression', 'diabetes and depression', '276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5']","['adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm', 'machine learning', 'text-messaging smartphone application']",['physical activity'],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439084', 'cui_str': '>5'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442598', 'cui_str': 'Bank'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0707012,"In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Figueroa', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA c.a.figueroa@berkeley.edu.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Hernandez-Ramos', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Cemballi', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gomez-Pathak', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Miramontes', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Yom-Tov', 'Affiliation': 'Microsoft Research, Herzeliya, Israel.'}, {'ForeName': 'Bibhas', 'Initials': 'B', 'LastName': 'Chakraborty', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Modiri', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Aggarwal', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jay Williams', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Lyles', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034723']
1829,32819997,The VRIMM study: Virtual Reality for IMMunisation pain in young children-protocol for a randomised controlled trial.,"INTRODUCTION


Pain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive 'virtual world', has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations.
METHODS AND ANALYSIS


The study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects.
ETHICS AND DISSEMINATION


Ethics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences.
TRIAL REGISTRATION NUMBER


ACTRN12618001363279.",2020,The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised.,"['100 children receiving routine 4-year-old vaccination', 'young children-protocol', 'Children attending a single general practice in metropolitan Melbourne, Australia', '4-year-old children receiving routine immunisations']","['VR intervention prior to vaccination in addition to standard care; the control group will receive standard care', 'Virtual reality (VR']","[""child's self-rated pain scores"", 'another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100\u2009mm visual analogue scales) and adverse effects', 'pain and distress', 'Faces Pain Scale-Revised']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",,0.108349,The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised.,"[{'ForeName': 'Kirrily', 'Initials': 'K', 'LastName': 'Ellerton', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Harishan', 'Initials': 'H', 'LastName': 'Tharmarajah', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Medres', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Lona', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ringelblum', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Kateena', 'Initials': 'K', 'LastName': 'Vogel', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Dolphin', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'McKellar', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Bridson', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'John-White', 'Affiliation': 'Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia Simon.Craig@monashhealth.org.'}]",BMJ open,['10.1136/bmjopen-2020-038354']
1830,32819999,"Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol.","INTRODUCTION


Community-acquired pneumonia (CAP) continues to be a major health problem worldwide and is one of the main reasons for prescribing antibiotics. However, the causative agent is often not identified, resulting in antibiotic overtreatment, which is a key driver of antimicrobial resistance and adverse events. We aim to test the hypothesis that comprehensive molecular testing, compared with routine microbiological testing, would be effective in reducing antibiotic use in patients with CAP.
METHODS AND ANALYSIS


We will perform a randomised, controlled, open-label clinical trial with two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022. Non-severely immunosuppressed adults hospitalised for CAP will be considered eligible. Patients will be randomly assigned to receive either the experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing). The primary endpoint will be antibiotic consumption measured as days of antibiotic therapy per 1000 patient-days. Secondary endpoints will be de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death from any cause by 48 hours and 30 days after randomisation. We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Ethics Committee of Bellvitge Hospital (AC028/19) and from the Spanish Medicines and Medical Devices Agency, and it is valid for all participating centres under existing Spanish legislation. Results will be presented at international meetings and will be made available to patients, their caregivers and funders.
TRIAL REGISTRATION NUMBER


ClinicalTrials: NCT04158492. EudraCT: 2018-004880-29.",2020,"We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
","['community-acquired pneumonia (RADICAP', '440 subjects', 'patients with CAP', 'two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022']","['comprehensive molecular testing', 'EudraCT', 'experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing']","['de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death', 'antibiotic consumption']","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.28202,"We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Abelenda-Alonso', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain gabi.abelenda.alonso@gmail.com.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rombauts', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Gudiol', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Meije', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ardanuy', 'Affiliation': ""Department of Clinical Microbiology Unit, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Niubó', 'Affiliation': ""Department of Clinical Microbiology Unit, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Padullés', 'Affiliation': ""Department of Farmacology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': ""Department of Clinical Farmacology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebe', 'Affiliation': ""Statistics Advisory Service, Institut d\\'Investigacio Biomedica de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}]",BMJ open,['10.1136/bmjopen-2020-038957']
1831,32820000,"Study protocol for a double-blind, randomised placebo-controlled trial evaluating clinical effects of platelet-rich plasma injection for acute grade-2 hamstring tear among high performance athletes.","INTRODUCTION


Hamstring injury among athletes often results in significant morbidity. Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
METHODS AND ANALYSIS


This study is a single-centre double-blind randomised placebo-controlled trial. Sixty-eight patients will be randomised to receive under ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline. All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist. Outcome data will be collected before intervention (baseline), and thereafter on a weekly basis. The primary outcome measure is the duration to return-to-play. It is defined as the duration (in days) from the date on which the injury occurred until the patients were pain-free, able to perform the active knee extension test and have regained hamstring muscle strength. Secondary outcome measures include assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory-Short Form questionnaire. Both the primary and secondary outcomes were assessed at baseline and thereafter once a week until return to play. Also, hamstring injury recurrence within the first 6 months after recovery will be monitored via telephone. The results of this study will provide insights into the effect of LR-PRP in muscle and may help to identify the best PRP application protocol for muscle injuries.
ETHICS AND DISSEMINATION


Ethics approval were obtained from the Medical Research Ethics Committee of the University of Malaya Medical Centre. Results of this trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ISRCTN76844299.",2020,"Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
","['All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist', 'acute grade-2 hamstring tear among high performance athletes', 'Sixty-eight patients']","['ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline', 'platelet-rich plasma injection', 'placebo']","['hamstring injury recurrence', 'duration to return-to-play', 'assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory-Short Form questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450387', 'cui_str': '68'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",68.0,0.577388,"Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
","[{'ForeName': 'Mohamad Shariff', 'Initials': 'MS', 'LastName': 'A Hamid', 'Affiliation': 'Sports Medicine, Universiti Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia ayip@um.edu.my.'}, {'ForeName': 'Kamarul Hashimy', 'Initials': 'KH', 'LastName': 'Hussein', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Ahmad Munawwar', 'Initials': 'AM', 'LastName': 'Helmi Salim', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Puji', 'Affiliation': 'Department of Orthopaedic and Traumatology, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Rosnah', 'Initials': 'R', 'LastName': 'Mat Yatim', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chin Chee', 'Initials': 'CC', 'LastName': 'Yong', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Thomas Wong Yong', 'Initials': 'TWY', 'LastName': 'Sheng', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}]",BMJ open,['10.1136/bmjopen-2020-039105']
1832,32820002,Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol.,"INTRODUCTION


Intracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO 2 ) and ICP during the first 5 days following severe TBI.
METHODS AND ANALYSIS


Multicentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO 2  group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO 2  group is managed to maintain PbtO 2  ≥20 mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze.
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament et des produits de santé) (141 435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications.The study was registered with ClinTrials NCT02754063 on 28 April 2016 (pre-results).",2020,"Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days.","['patients at the early phase of severe traumatic brain injury', '28 April 2016 (pre-results', '300 patients with severe TBI']","['ICP + PbtO 2  group', 'ICP']","['quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days', 'neurological status at 6 months as assessed using the extended Glasgow Outcome Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0378456', 'cui_str': '3,4,4a,10b-tetrahydro-4-propyl-2H,5H-(1)benzopyrano(4,3-b)-1,4-oxazin-9-ol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}]",300.0,0.102688,"Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days.","[{'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France jfpayen@univ-grenoble-alpes.fr.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Richard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Francony', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Audibert', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Lorraine University, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Emmanuel L', 'Initials': 'EL', 'LastName': 'Barbier', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aix-Marseille University, Assistance Publique - Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Poitiers University Hospital and Poitiers Hospital, Pharmacology of antimicrobial agents, INSERM U1070, Poitiers, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Geeraerts', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Toulouse University Hospital and Toulouse 3-Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gergele', 'Affiliation': 'Department of Intensive care, Ramsay Sante, Hopital Privé de la Loire, Saint-Etienne, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Puybasset', 'Affiliation': 'Department of Anaesthesia and Critical Care, Sorbonne University, GRC 29, AP-HP, DMU DREAM, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Vigue', 'Affiliation': 'Department of Anaesthesia and Intensive care, Centre Hospitalier Universitaire de Bicêtre, Assistance Publique - Hopitaux de Paris, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Skaare', 'Affiliation': 'Department of Public Health, Univ. Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC IMAG, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bouzat', 'Affiliation': 'Centre Hospitalier Universitaire de Grenoble, Grenoble, France.'}]",BMJ open,['10.1136/bmjopen-2020-040550']
1833,32820879,Treating Scalp Psoriasis with Calcipotriene/Betamethasone Dipropionate Fixed-dose Combination Cutaneous Foam: Review of Phase 2 Data,"Two Phase 2 studies investigated the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in adult and adolescent patients. Patients had psoriasis classified as at least 'mild' per PGA. NCT01536938 enrolled adult patients (≥18 years) randomized 1:1:1 to once-daily (QD) Cal/BD foam (Cal 0.005%, BD 0.064%), Cal foam (0.005%) or BD foam (0.064%). NCT02387853 enrolled adolescent patients (12- <17 years) to Cal/BD foam QD (dose as previously). Treatment success was based on improvement in PGA classification at week 4. Additional efficacy endpoints included mPASI in adults and effect on extent of scalp surface area (SSA) in adolescents. Safety was also assessed. Overall, 302 adults (n=100 Cal/BD foam; n=101 Cal foam; n=101 BD foam) and 106 adolescents received treatment. Treatment success in adults was significantly higher with Cal/BD vs Cal foam (53.0% vs 35.6%, P=0.021) and numerically higher than with BD foam (47.5%, P=0.45). Mean percentage changes in mPASI were -80.0%, -57.8% and -71.2%, for Cal/BD, Cal and BD foam, respectively. In adolescents, 73.6% of patients treated with Cal/BD foam achieved treatment success and mean SSA fell from 50.6% at baseline to 12.5% at week 4. All treatment-related AEs were considered mild-to-moderate across both studies, except one severe AE (hypersensitivity reaction with urticaria) in the adult Cal/BD foam group, which led to withdrawal from the study. In these studies, treatment of scalp psoriasis with Cal/BD foam provided good efficacy for adults and adolescents and was generally well tolerated. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5168.",2020,"Mean percentage changes in mPASI were -80.0%, -57.8% and -71.2%, for Cal/BD, Cal and BD foam, respectively.","['302 adults (n=100 Cal/BD foam; n=101 Cal foam; n=101 BD foam) and 106 adolescents received treatment', 'adult and adolescent patients', ""Patients had psoriasis classified as at least 'mild' per PGA"", 'NCT01536938 enrolled adult patients (≥18 years', 'NCT02387853 enrolled adolescent patients (12- <17 years) to Cal/BD foam QD (dose as previously', 'adolescents']","['fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD', 'Calcipotriol/Betamethasone Dipropionate', 'Cal/BD']","['Safety', 'tolerated', 'Mean percentage changes in mPASI', 'scalp psoriasis', 'treatment success and mean SSA fell', 'extent of scalp surface area (SSA', 'severe AE (hypersensitivity reaction with urticaria']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3474001', 'cui_str': 'Calcipotriol monohydrate'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3474001', 'cui_str': 'Calcipotriol monohydrate'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated adenoma'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}]",302.0,0.0618305,"Mean percentage changes in mPASI were -80.0%, -57.8% and -71.2%, for Cal/BD, Cal and BD foam, respectively.","[{'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849']
1834,32821038,Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT.,"BACKGROUND


Major trauma is the leading cause of death in people aged < 45 years. Patients with major trauma usually have lower-limb fractures. Surgery to fix the fractures is complicated and the risk of infection may be as high as 27%. The type of dressing applied after surgery could potentially reduce the risk of infection.
OBJECTIVES


To assess the deep surgical site infection rate, disability, quality of life, patient assessment of the surgical scar and resource use in patients with surgical incisions associated with fractures following major trauma to the lower limbs treated with incisional negative-pressure wound therapy versus standard dressings.
DESIGN


A pragmatic, multicentre, randomised controlled trial.
SETTING


Twenty-four specialist trauma hospitals representing the UK Major Trauma Network.
PARTICIPANTS


A total of 1548 adult patients were randomised from September 2016 to April 2018. Exclusion criteria included presentation > 72 hours after injury and inability to complete questionnaires.
INTERVENTIONS


Incisional negative-pressure wound therapy ( n  = 785), in which a non-adherent absorbent dressing covered with a semipermeable membrane is connected to a pump to create a partial vacuum over the wound, versus standard dressings not involving negative pressure ( n  = 763). Trial participants and the treating surgeon could not be blinded to treatment allocation.
MAIN OUTCOME MEASURES


Deep surgical site infection at 30 days was the primary outcome measure. Secondary outcomes were deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery.
RESULTS


A total of 98% of participants provided primary outcome data. There was no evidence of a difference in the rate of deep surgical site infection at 30 days. The infection rate was 6.7% (50/749) in the standard dressing group and 5.8% (45/770) in the incisional negative-pressure wound therapy group (intention-to-treat odds ratio 0.87; 95% confidence interval 0.57 to 1.33;  p  = 0.52). There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19;  p  = 0.32). There was no difference between the two groups in disability, quality of life or scar appearance at 3 or 6 months. Incisional negative-pressure wound therapy did not reduce the cost of treatment and was associated with a low probability of cost-effectiveness.
LIMITATIONS


Owing to the emergency nature of the surgery, we anticipated that some patients who were randomised would subsequently be unable or unwilling to participate. However, the majority of the patients (85%) agreed to participate. Therefore, participants were representative of the population with lower-limb fractures associated with major trauma.
CONCLUSIONS


The findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to the lower limbs.
FUTURE WORK


Our work suggests that the use of incisional negative-pressure wound therapy dressings in other at-risk surgical wounds requires further investigation. Future research may also investigate different approaches to reduce postoperative infections, for example the use of topical antibiotic preparations in surgical wounds and the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN12702354 and UK Clinical Research Network Portfolio ID20416.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 38. See the NIHR Journals Library for further project information.",2020,"There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19;  p  = 0.32).","['participants were representative of the population with lower-limb fractures associated with major trauma', 'patients having surgery for major trauma to the lower limbs', 'Twenty-four specialist trauma hospitals representing the UK Major Trauma Network', 'people aged <\u200945 years', 'A total of 1548 adult patients were randomised from September 2016 to April 2018', 'patients with surgical incisions associated with fractures following major trauma to the lower limbs treated with', 'Patients with major trauma usually have lower-limb fractures']","['negative-pressure wound therapy', 'incisional negative-pressure wound therapy dressings', 'Negative-pressure wound therapy', 'incisional negative-pressure wound therapy versus standard dressings', 'Incisional negative-pressure wound therapy']","['deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery', 'deep surgical site infection rate', 'infection rate', 'disability, quality of life or scar appearance', 'rate of deep surgical site infection', 'risk of infection', 'deep surgical site infection rate, disability, quality of life, patient assessment of the surgical scar and resource use']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0334150', 'cui_str': 'Surgical scar'}]",1548.0,0.129949,"There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19;  p  = 0.32).","[{'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Vadher', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Masters', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Spoors', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Campolier', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Patient and public involvement group member.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Patient and public involvement group member.'}, {'ForeName': 'Jagdeep', 'Initials': 'J', 'LastName': 'Nanchahal', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24380']
1835,32821078,Epigastric pain syndrome: What can traditional Chinese medicine do? A randomized controlled trial of Biling Weitong Granules.,"BACKGROUND


Recent research suggests that although prokinetic agents, acid suppressors, and radical treatment for  Helicobacter pylori  infection may be effective in patients with functional dyspepsia (FD), a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a traditional Chinese medicinal herbal compound formula, in alleviating epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease.
AIM


To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.
METHODS


In this multicenter, stratified, randomized, double-blind, placebo-controlled, parallel group clinical trial, eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk. Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.
RESULTS


The baseline demographic data and clinical characteristics, such as epigastric pain symptoms, pain intensity, and frequency of attacks, were matched between the two groups before randomization. After 6 wk of treatment and after the center effect was eliminated, the epigastric pain was significantly improved in 28.33% and 85.59% of the patients in the placebo and BLWTG groups, respectively ( P  < 0.05). At 6 wk, the resolution rate of epigastric pain was 15% and 69.49% in the placebo and BLWTG groups, respectively ( P  < 0.05). The differences of total FD clinical score between these two groups were significant ( P  < 0.05) at 2, 4, and 6 wk ( P  < 0.05). The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated ( P  < 0.05). There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
CONCLUSION


Compared with placebo, BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.",2020,"There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
","['patients with functional dyspepsia (FD', 'epigastric pain syndrome (EPS) in FD patients', 'Epigastric pain syndrome', 'patients with FD.\nMETHODS']","['Biling Weitong Granules (BLWTG', 'BLWTG', 'placebo']","['total score in the Functional Digestive Disorders Quality of Life Questionnaire', 'clinical efficacy and safety', 'epigastric pain', 'EPS', 'resolution rate of epigastric pain', 'total FD clinical score', 'epigastric pain symptoms, pain intensity, and frequency of attacks', 'severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0012242', 'cui_str': 'Disorder of digestive system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0059954', 'cui_str': 'Exophthalmos producing substance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.153839,"There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
","[{'ForeName': 'Yan-Dong', 'Initials': 'YD', 'LastName': 'Wen', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Institution of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Ying-Pan', 'Initials': 'YP', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Hebei Provincial Hospital of Chinese Medicine, Shijiazhuang 050011, Hebei Province, China.'}, {'ForeName': 'Jun-Xiang', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Hui-Zhen', 'Initials': 'HZ', 'LastName': 'Li', 'Affiliation': 'Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Chi', 'Affiliation': 'Department of Gastroenterology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China.'}, {'ForeName': 'Zheng-Hua', 'Initials': 'ZH', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Tianjin Nankai Hospital, Tianjin 300100, China.'}, {'ForeName': 'Jin-Kang', 'Initials': 'JK', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, The Kunshan Hospital Affiliated to Nanjing University of Chinese Medicine, Kunshan 215300, Jiangsu Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Institution of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. txdly@sina.com.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i28.4170']
1836,32821082,"Simple Methods for Evaluating 4 Types of Biomarkers: Surrogate Endpoint, Prognostic, Predictive, and Cancer Screening.","We review simple methods for evaluating 4 types of biomarkers. First, we discuss the evaluation of surrogate endpoint biomarkers (to shorten a randomized trial) using 2 statistical and 3 biological criteria. Second, we discuss the evaluation of prognostic biomarkers (to predict the risk of disease) by comparing data collection costs with the anticipated net benefit of risk prediction. Third, we discuss the evaluation of predictive markers (to search for a promising subgroup in a randomized trial) using a multivariate subpopulation treatment effect pattern plot involving a risk difference or responders-only benefit function. Fourth, we discuss the evaluation of cancer screening biomarkers (to predict cancer in asymptomatic persons) using methodology to substantially reduce the sample size with stored specimens.",2020,"Fourth, we discuss the evaluation of cancer screening biomarkers (to predict cancer in asymptomatic persons) using methodology to substantially reduce the sample size with stored specimens.",[],[],[],[],[],[],,0.064939,"Fourth, we discuss the evaluation of cancer screening biomarkers (to predict cancer in asymptomatic persons) using methodology to substantially reduce the sample size with stored specimens.","[{'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Baker', 'Affiliation': 'Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Barnett S', 'Initials': 'BS', 'LastName': 'Kramer', 'Affiliation': 'Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}]",Biomarker insights,['10.1177/1177271920946715']
1837,32821083,A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK).,"Purpose


To determine the preference of patients undergoing bilateral LASIK for either the dexamethasone intracanalicular insert or topical prednisolone acetate for control of postoperative symptoms and ocular surface signs.
Methods


In this randomized clinical trial, one eye was randomized to receive the dexamethasone insert or topical prednisolone acetate 1% four times daily for one week and 2 times daily for a second week; the fellow eye received the alternate therapy. One month postoperatively, patient preference for these two therapies was assessed using an adapted COMTOL questionnaire. Ocular comfort was assessed using the SPEED questionnaire. Corneal staining and uncorrected distance visual acuity (UDVA) were also assessed.
Results


Twenty patients participated. At Month 1, 80% of patients preferred the dexamethasone insert, 10% preferred prednisolone acetate, and 10% expressed no preference (p<0.001). SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms were similar between groups (p=0.72), and both the incidence of patient-reported ocular dryness and the corneal staining scores were similar between groups. Both groups attained the same final UDVA.
Conclusion


Patients undergoing elective bilateral femtosecond LASIK surgery overwhelmingly (by an 8-to-1 margin) preferred the dexamethasone insert to topical prednisolone acetate for postoperative treatment. The insert produced comparable ocular comfort, corneal staining, and visual acuity outcomes to topical prednisolone. The insert is an appropriate means of postoperative symptom control in this quality of life-conscious population.",2020,"SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms were similar between groups (p=0.72), and both the incidence of patient-reported ocular dryness and the corneal staining scores were similar between groups.","['Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK', 'Twenty patients participated', 'patients undergoing bilateral LASIK for either the']","['elective bilateral femtosecond LASIK surgery', 'dexamethasone', 'prednisolone acetate', 'prednisolone', 'Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate', 'topical prednisolone acetate', 'dexamethasone intracanalicular insert or topical prednisolone acetate']","['SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms', 'ocular comfort, corneal staining, and visual acuity outcomes', 'ocular dryness and the corneal staining scores', 'Corneal staining and uncorrected distance visual acuity (UDVA', 'Ocular comfort']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}]",20.0,0.116557,"SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms were similar between groups (p=0.72), and both the incidence of patient-reported ocular dryness and the corneal staining scores were similar between groups.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Greenwood', 'Affiliation': 'Vance Thompson Vision, West Fargo, ND, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Gorham', 'Affiliation': 'Ektropia Solutions LLC, Laguna Beach, CA, USA.'}, {'ForeName': 'Keeley R', 'Initials': 'KR', 'LastName': 'Boever', 'Affiliation': 'Ektropia Solutions LLC, Laguna Beach, CA, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S265311']
1838,32821089,Hormonal Function Responses to Moderate Aerobic Exercise in Older Adults with Depression.,"Background


Poor daily life physical activities among older people were related to depressive mood especially memory loss. In addition to that, the change in physical ability is significantly associated with the score of depression among older age.
Objective


The present study aimed to evaluate the effects of a supervised aerobic training program with moderate intensity for 12 weeks on mood profiles and hormonal levels of the hypothalamus-pituitary-adrenal axis (HPA axis) of older adults.
Methods


A total of 80 individuals of both gender (90 males, 110 females) of ages ranged between 65 and 95 years were recruited for this study. Based upon the profile of mood states (POMS) analysis, the participants were classified into two groups: control group (n=30) and depressive group (n=50). Leisure-time physical activity (LTPA), adrenal hormones such as ACTH, corticosterone (CORT), cortisol, DHEA/S, and cortisol:DHEA/S ratio were measured at baseline and post-intervention of moderate aerobic exercise for 12 weeks.
Results


Older adults with higher depressive scores showed a remarkable change in the level of adrenal hormones compared to control. There was a significant increase in the level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S. Compared to females, males showed an improvement in depressive mood score along with an increase in LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol:DHEA/S ratio following 12 weeks of supervised aerobic training, respectively.
Conclusion


The findings of this study showed that 12 weeks of supervised exercise interventions are promising non-drug therapeutic strategies in improving depression among older adults. The potential performance in a psychological state occurs physiologically via optimizing the levels of the hormones of the HPA axis.",2020,"There was a significant increase in the level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S. Compared to females, males showed an improvement in depressive mood score along with an increase in LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol:","['older adults', '80 individuals of both gender (90 males, 110 females) of ages ranged between 65 and 95 years', 'older people', 'participants were classified into two groups: control group (n=30) and depressive group (n=50', 'Older Adults with Depression']","['Hormonal Function Responses to Moderate Aerobic Exercise', 'supervised exercise interventions', 'supervised aerobic training program']","['depressive mood score', 'level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S', 'LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol', 'level of adrenal hormones', 'mood profiles and hormonal levels of the hypothalamus-pituitary-adrenal axis (HPA axis', 'Leisure-time physical activity (LTPA), adrenal hormones such as ACTH, corticosterone (CORT), cortisol, DHEA/S, and cortisol:DHEA/S ratio']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0010124', 'cui_str': 'Corticosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0348598,"There was a significant increase in the level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S. Compared to females, males showed an improvement in depressive mood score along with an increase in LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol:","[{'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair (RRC), College of Applied Medical Sciences (CAMS), King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Sami A', 'Initials': 'SA', 'LastName': 'Gabr', 'Affiliation': 'Rehabilitation Research Chair (RRC), College of Applied Medical Sciences (CAMS), King Saud University, Riyadh, Kingdom of Saudi Arabia.'}]",Clinical interventions in aging,['10.2147/CIA.S259422']
1839,32821109,A Randomized Controlled Trial Comparing Analgesic Efficacies of an Ultrasound-Guided Approach with and without a Combined Pressure Measurement Technique for Thoracic Paravertebral Blocks After Open Thoracotomy.,"Purpose


Ultrasound-guided thoracic paravertebral block (TPVB) is an established means for providing postoperative analgesia in thoracic surgery. However, there are conflicting results regarding the efficacy of post-thoracotomy pain management of ultrasound-guided TPVB when compared with that using traditional landmark approach. We therefore conducted a comparative study to evaluate the analgesic efficacy of TPVB when pressure measurement during needle advancement is combined with an ultrasound-guided approach.
Patients and Methods


The patients scheduled for lobectomy through thoracotomy were randomly allocated to receive either the ultrasound-guided approach only group (U group) or the ultrasound-guided approach combined with pressure measurement group (UP group) (n = 36 per group). Before thoracic muscle closure, 0.375% ropivacaine (20 mL) was administered as a bolus, followed by a continuous infusion of 0.2% ropivacaine (0.1 mL/kg/hr) in both groups. Postoperative pain was assessed using the visual analogue scale (VAS) pain score while resting and coughing. Local anesthetics and pethidine usage and sensory block area were also evaluated.
Results


The UP group showed significantly lower VAS scores, local anesthetics and pethidine usage, and a wider sensory block area than the U group.
Conclusion


A combined technique with ultrasound guidance and pressure measurement provided a superior analgesic effect over that of an ultrasound-guided approach alone for the management of post-thoracotomy pain.",2020,"The UP group showed significantly lower VAS scores, local anesthetics and pethidine usage, and a wider sensory block area than the U group.
","['thoracic surgery', 'patients scheduled for lobectomy through thoracotomy']","['Ultrasound-Guided Approach with and without a Combined Pressure Measurement Technique for Thoracic Paravertebral Blocks', 'ropivacaine', 'Ultrasound-guided thoracic paravertebral block (TPVB', 'ultrasound-guided approach only group (U group) or the ultrasound-guided approach combined with pressure measurement group (UP group', 'TPVB']","['Postoperative pain', 'VAS scores, local anesthetics and pethidine usage, and a wider sensory block area', 'visual analogue scale (VAS) pain score while resting and coughing']","[{'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",,0.0605639,"The UP group showed significantly lower VAS scores, local anesthetics and pethidine usage, and a wider sensory block area than the U group.
","[{'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Ji-Il', 'Initials': 'JI', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}]",Therapeutics and clinical risk management,['10.2147/TCRM.S263353']
1840,32821177,Impact of Intraoperative Fluid Management on Electrolyte and Acid-Base Variables During Posterior Spinal Fusion in Adolescents.,"Introduction


Various isotonic fluids may be used to maintain intravascular homeostasis during major surgical procedures. Variations in the electrolyte and buffer concentrations between these solutions may result in differential changes in electrolyte and acid-base status during fluid resuscitation. This study evaluates these changes during posterior spinal fusion in adolescents.
Methods


Patients were randomized to receive lactated Ringers (LR), normal saline (NS) or Normosol-R® (NR) during posterior spinal fusion (N=19, 20, and 20, respectively). The specific fluid was used for maintenance fluids as well as fluid replacement of deficits, third space losses, and blood loss.
Results


Patients who received NS had a greater base deficit (NS: -2.0 ± 2.2 vs NR -0.6 ± 1.8, p=0.031 or LR: -0.2 ± 1.7, p=0.007) and were more likely to have a ≥2 point change in the base deficit (60% with NS compared to 30% with NR and 47% with LR). Patients receiving NS also had a lower pH (NS: 7.37 ± 0.03 vs NR: 7.39 ± 0.04, p=0.013) and a greater change in pH (NS: -0.03 ± 0.04 vs NR: 0.01 ± 0.06).
Conclusion


The use of NS for intraoperative resuscitation during posterior spinal fusion in adolescents resulted in a greater base deficit and a lower pH than the use of LR or NR. Although these changes had limited clinical significance in our patient population, future studies are indicated to further investigate the potential clinical impact of these changes.",2020,The use of NS for intraoperative resuscitation during posterior spinal fusion in adolescents resulted in a greater base deficit and a lower pH than the use of LR or NR.,"['Adolescents', 'adolescents']","['Intraoperative Fluid Management', 'lactated Ringers (LR), normal saline (NS) or Normosol-R® (NR']",['Electrolyte and Acid-Base Variables'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0069013', 'cui_str': 'Normosol-R'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.279124,The use of NS for intraoperative resuscitation during posterior spinal fusion in adolescents resulted in a greater base deficit and a lower pH than the use of LR or NR.,"[{'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Miketic', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Beebe', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Samora', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klamar', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Tumin', 'Affiliation': 'Department of Pediatrics, Brody School of Medicine at East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}]",Orthopedic research and reviews,['10.2147/ORR.S262509']
1841,32821251,The Effects of a Recollection-Based Occupational Therapy Program of Alzheimer's Disease: A Randomized Controlled Trial.,"Considering the high socioeconomic costs related to the increasing number of dementia patients and their poor quality of life and that of their families, it is important to identify the condition early on and provide an appropriate intervention. This study organized a recollection-based occupational therapy program: a nonpharmacological intervention consisting of five categories of activities (physical, horticultural, musical, art, and instrumental activity of daily living; IADL) and applied it to those having a mild stage of Alzheimer's disease. The experimental group participated in a total of 24 sessions--five times per week for one hour per session--while the control group took part in regular activities offered by the existing facilities. The experimental group presented improved cognitive functions, reduced depression, and enhanced quality of life; the two groups showed a statistically significant difference in every category. This study is meaningful in that it made a cognitive stimulation program concerning five different categories, implemented it for people suffering mild dementia, and confirmed positive outcomes. If a systemic version of the program is offered in dementia care facilities, it is expected to make a considerable contribution to the care of dementia patients.",2020,"The experimental group presented improved cognitive functions, reduced depression, and enhanced quality of life; the two groups showed a statistically significant difference in every category.","[""Alzheimer's Disease""]","['Recollection-Based Occupational Therapy Program', 'activities (physical, horticultural, musical, art, and instrumental activity of daily living; IADL']","['cognitive functions, reduced depression, and enhanced quality of life']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0211207,"The experimental group presented improved cognitive functions, reduced depression, and enhanced quality of life; the two groups showed a statistically significant difference in every category.","[{'ForeName': 'DeokJu', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Cheongju University, Daesung-ro, 298, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea.'}]",Occupational therapy international,['10.1155/2020/6305727']
1842,32821255,Effects of fish oil during hemodialysis on nutritional status and quality of life: a randomized double-blinded trial.,"Background


Supplementation of fish oil has been shown to exert beneficial effects in patients undergoing hemodialysis. The aim of this study was to investigate the efficacy of fish oil in improving the quality of life of these patients through a randomized, double-blinded clinical trial.
Methods


Among the 103 patients enrolled in the study, a total of 74 patients were randomized to receive fish oil (intervention group) or placebo ( n =37 per group). Patients received identical soft-gel capsules, with each capsule containing either 1000 mg fish oil or placebo for 4 months. Personnel responsible for data collection and analyses were blinded to the grouping.
Results


The reduction of protein-energy wasting (PEW) in the intervention group was significantly more prominent compared to the placebo group ( P =0.023). The intervention group demonstrated significant increase in midarm circumference, arm muscle circumference, and triceps skinfold thickness after fish oil intake. The intervention group also exhibited significant differences from the placebo group in creatinine, uric acid, and serum calcium levels. Significant improvement was seen regarding the physical role and energy/figure in the intervention group.
Conclusions


Our study demonstrated that fish oil intake in patient undergoing hemodialysis can significantly reduce PEW, and improve physical and biochemical parameters and quality of life, which could provide guidance to clinical management of these patients.",2020,"The intervention group demonstrated significant increase in midarm circumference, arm muscle circumference, and triceps skinfold thickness after fish oil intake.","['103 patients enrolled in the study, a total of 74 patients', 'patient undergoing hemodialysis', 'patients undergoing hemodialysis']","['fish oil (intervention group) or placebo', 'fish oil', 'identical soft-gel capsules, with each capsule containing either 1000 mg fish oil or placebo', 'placebo']","['quality of life', 'nutritional status and quality of life', 'creatinine, uric acid, and serum calcium levels', 'physical and biochemical parameters and quality of life', 'reduction of protein-energy wasting (PEW', 'physical role and energy/figure', 'midarm circumference, arm muscle circumference, and triceps skinfold thickness']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518022', 'cui_str': 'Triceps skin fold thickness'}]",74.0,0.659958,"The intervention group demonstrated significant increase in midarm circumference, arm muscle circumference, and triceps skinfold thickness after fish oil intake.","[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Ge', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, The Affiliated Suqian Hospital of Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The Affiliated Suqian Hospital of Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Xuzhou Medical University, Jiangsu, China.'}]",Food & nutrition research,['10.29219/fnr.v64.4450']
1843,32821284,Combined Aerobic and Resistance Exercises Evokes Longer Reductions on Ambulatory Blood Pressure in Resistant Hypertension: A Randomized Crossover Trial.,"Aim


The present study compared the acute effects of aerobic (AER), resistance (RES), and combined (COM) exercises on blood pressure (BP) levels in people with resistant hypertension (RH) and nonresistant hypertension (NON-RH).
Methods


Twenty patients (10 RH and 10 NON-RH) were recruited and randomly performed three exercise sessions and a control session. Ambulatory BP was monitored over 24 hours after each experimental session.
Results


Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions. Notably, ambulatory BP was reduced during awake-time and night-time periods after COM. On the other hand, the effects of AER were more prominent during awake periods, while RES caused greater reductions during the night-time period. In NON-RH, only RES acutely reduced systolic BP, while diastolic BP was reduced after all exercise sessions. However, the longest postexercise ambulatory hypotension was observed after AER (~11 h) in comparison to RES (~8 h) and COM (~4 h) exercises.
Conclusion


Findings of the present study indicate that AER, RES, and COM exercises elicit systolic and diastolic postexercise ambulatory hypotension in RH patients. Notably, longer hypotension periods were observed after COM exercise. In addition, NON-RH and RH people showed different changes on BP after exercise sessions, suggesting that postexercise hypotension is influenced by the pathophysiological bases of hypertension.",2020,"Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions.","['Twenty patients (10 RH and 10 NON-RH', 'Resistant Hypertension', 'people with resistant hypertension (RH) and nonresistant hypertension (NON-RH', 'RH patients']","['exercise sessions and a control session', 'Combined Aerobic and Resistance Exercises Evokes', 'aerobic (AER), resistance (RES), and combined (COM) exercises']","['AER, RES, and COM exercises elicit systolic and diastolic postexercise ambulatory hypotension', 'BP', 'ambulatory BP', 'Ambulatory Blood Pressure', 'systolic BP, while diastolic BP', 'longest postexercise ambulatory hypotension', 'longer hypotension periods', 'postexercise hypotension', 'Ambulatory BP', 'blood pressure (BP) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0262751,"Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions.","[{'ForeName': 'Nayara Fraccari', 'Initials': 'NF', 'LastName': 'Pires', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Helio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Laboratory of Cardiovascular Investigation and Exercise, School of Physical Education (FEF), University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Bruno Bavaresco', 'Initials': 'BB', 'LastName': 'Gambassi', 'Affiliation': 'Laboratory of Cardiovascular Investigation and Exercise, School of Physical Education (FEF), University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Ana Paula Cabral', 'Initials': 'APC', 'LastName': 'de Faria', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Alessandra Mileni Versuti', 'Initials': 'AMV', 'LastName': 'Ritter', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'de Andrade Barboza', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Silvia Elaine', 'Initials': 'SE', 'LastName': 'Ferreira-Melo', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Heitor Moreno', 'Initials': 'HM', 'LastName': 'Júnior', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}]",Cardiovascular therapeutics,['10.1155/2020/8157858']
1844,32821287,Comparison of the effect of clarithromycin triple therapy with or without  N -acetylcysteine in the eradication of  Helicobacter pylori : a randomized controlled trial.,"Background


Whether adjunctive  N -acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of  Helicobacter pylori  infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of  H. pylori .
Material and methods


Between 1 January 2014 and 30 June 2018, 680 patients with  H. pylori  infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC [NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d.] for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and  CYP2C19  gene polymorphism were determined.
Results


The ITT analysis demonstrated  H. pylori  eradication rates in NAC-T14 and T14 were 81.7% [276/338, 95% confidence interval (CI): 77.5-85.8%] and 84.3% (285/338, 95% CI 80.4-88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by  CYP2C19  polymorphism.
Conclusion


Add-on NAC to triple therapy was not superior to triple therapy alone for first-line  H. pylori  eradication [ClinicalTrials.gov identifier: NCT02249546].",2020,"The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14.","['subjects with clarithromycin-resistant, amoxicillin-resistant, or either', 'Between 1 January 2014 and 30 June 2018, 680 patients with  H. pylori  infection naïve to treatment', 'Helicobacter pylori ', '646 participants who adhered to their assigned therapy, the']","['adjunctive  N -acetylcysteine (NAC', 'clarithromycin triple therapy with or without  N -acetylcysteine', 'clarithromycin 500\u2009mg b.i.d., NAC 600\u2009mg b.i.d.] for 14\u2009days, or triple therapy alone (T14, dexlansoprazole 60\u2009mg q.d.; amoxicillin', 'triple therapy with NAC [NAC-T14, dexlansoprazole 60\u2009mg four times daily (q.d.); amoxicillin', 'clarithromycin/amoxicillin', 'clarithromycin']","['compliance or adverse effects', 'H. pylori  eradication rates', 'Antibiotic resistance and  CYP2C19  gene polymorphism', 'eradication rates by intention to treat (ITT', 'eradication rates']","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2608717', 'cui_str': 'dexlansoprazole 60 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",680.0,0.0856568,"The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14.","[{'ForeName': 'Chieh-Chang', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jiing-Chyuan', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Fang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ji-Yuh', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Kuo', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Tsung-Hua', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Min-Chin', 'Initials': 'MC', 'LastName': 'Chiu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Jian-Jyun', 'Initials': 'JJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Ming-Jong', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan.'}, {'ForeName': 'Po-Yueh', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chu-Kuang', 'Initials': 'CK', 'LastName': 'Chou', 'Affiliation': 'Department of Internal Medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chi-Yi', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chi-Yang', 'Initials': 'CY', 'LastName': 'Chang', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Yao-Chun', 'Initials': 'YC', 'LastName': 'Hsu', 'Affiliation': 'Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan.'}, {'ForeName': 'Cheng-Hao', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Internal Medicine, E-DA Cancer Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Hu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.'}, {'ForeName': 'Min-Horn', 'Initials': 'MH', 'LastName': 'Tsai', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.'}, {'ForeName': 'Cheng-Lin', 'Initials': 'CL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.'}, {'ForeName': 'Mei-Jyh', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chia-Tung', 'Initials': 'CT', 'LastName': 'Shun', 'Affiliation': 'Department of Pathology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tzeng-Ying', 'Initials': 'TY', 'LastName': 'Liu', 'Affiliation': 'Health Bureau of Lienchiang County, Nangan Hsiang, Lienchiang County, Matsu, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jyh-Ming', 'Initials': 'JM', 'LastName': 'Liou', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, No. 7, Chung-Shan S. Road, Taipei Taiwan.'}, {'ForeName': 'Ming-Shiang', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, No. 7, Chung-Shan S. Road, Taipei Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Therapeutic advances in gastroenterology,['10.1177/1756284820927306']
1845,32821419,Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F).,"Background


The aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the outpatient setting.
Methods


An open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥ 16 years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners' questionnaire.
Results


During the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess ( n  = 20) and CRB ( n  = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL ( n  = 22), preference for inpatient IOL ( n  = 22) and preference for a specific method, Propess ( n  = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the dinoprostone group and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. - 21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group.
Conclusions


A third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers.
Trial registration


NCT03199820. Registered on June 27, 2017.",2020,No deaths were recorded.,"['Women aged ≥\u200916\u2009years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible', '274 eligible women were identified', 'two UK maternity units from October 2017 to March 2019', '93 women', ""Women who declined to participate were requested to complete a decliners' questionnaire"", 'outpatient labour induction']","['dinoprostone', 'CRB', 'RCT', 'Prostaglandin insert dinoprostone', 'cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess', 'trans-cervical balloon catheter']","['Spontaneous vaginal delivery', 're-admitted prior to diagnosis of active labour', 'Severe maternal adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C2931258', 'cui_str': 'Amaurosis congenita of Leber, type 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1960759', 'cui_str': 'Cervical ripening with balloon'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",274.0,0.118362,No deaths were recorded.,"[{'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Bhide', 'Affiliation': ""Fetal Medicine Unit, St. George's University Hospital Foundation Trust, Blackshaw Road, London, SW17 0QT UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Sedgwick', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': ""King's Clinical Trials Unit, London, UK.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Cupples', 'Affiliation': ""Fetal Medicine Unit, St. George's University Hospital Foundation Trust, Blackshaw Road, London, SW17 0QT UK.""}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Coates', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Goode', 'Affiliation': ""Maternity Voices Partnership Chair, St. George's University Hospital Foundation Trust, London, UK.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Linton', 'Affiliation': ""Fetal Medicine Unit, St. George's University Hospital Foundation Trust, Blackshaw Road, London, SW17 0QT UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCourt', 'Affiliation': 'City, University of London, London, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00661-7']
1846,32821420,Peer navigation for individuals with serious mental illness leaving jail: a pilot randomized trial study protocol.,"Background


Serious mental illness (SMI) is a prevalent public health problem affecting 25% of individuals in jail. Re-entry to the community following incarceration is a vulnerable time for justice-involved individuals with SMI. SMI requires prompt and ongoing access to mental health and other healthcare services.
Methods


The study will (1) develop a Mentoring And Peer Support (MAPS) intervention for post-release mental health and other service connection among jailed individuals with SMI and (2) pilot test the MAPS intervention to determine its feasibility and acceptability. The primary outcomes will be to evaluate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, and of delivering the enhanced peer-navigator and control interventions. Study samples include focus groups (n=36), open trial (n=15), and a randomized pilot trial in a sample of 40 individuals with SMI re-entering the community after jail release. Secondary outcomes will include post-release enrollment in mental health, medical care, and substance use services. We will also evaluate reduction in psychiatric symptoms, improvements in functioning, adherence to psychiatric medications, fewer substance using days, fewer hospitalizations and suicide attempts, nights unstably housed, and time until rearrest.
Discussion


This pilot study will evaluate the feasibility and acceptability of a peer navigation intervention for individuals with serious mental illness leaving jails. The study will serve as a formative work for a larger randomized controlled trial assessing the effectiveness of peer navigator intervention for (include the primary outcome) in this population.",2020,This pilot study will evaluate the feasibility and acceptability of a peer navigation intervention for individuals with serious mental illness leaving jails.,"['jailed individuals with SMI and (2', 'individuals with serious mental illness leaving jail', 'individuals with serious mental illness leaving jails', '40 individuals with SMI re-entering the community after jail release']","['peer navigation intervention', 'Mentoring And Peer Support (MAPS) intervention', 'peer navigator intervention', 'Peer navigation', 'MAPS intervention']","['feasibility and acceptability', 'feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, and of delivering the enhanced peer-navigator and control interventions', 'post-release enrollment in mental health, medical care, and substance use services']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",40.0,0.181935,This pilot study will evaluate the feasibility and acceptability of a peer navigation intervention for individuals with serious mental illness leaving jails.,"[{'ForeName': 'Maji', 'Initials': 'M', 'LastName': 'Hailemariam', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine, Michigan State University, East Lansing, MI USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Weinstock', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School of Brown University, Providence, RI USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Johnson', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine, Michigan State University, East Lansing, MI USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00659-1']
1847,32821422,Self-administration of medication during hospitalization-a randomized pilot study.,"Background


Self-administration of medication (SAM) during hospitalization is a complex intervention where patients are involved in their course of treatment. The study aim was to pilot test the SAM intervention. The objectives were to assess the feasibility of conducting a randomized controlled trial on the safety and cost-consequences of SAM during hospitalization.
Methods


The study was performed in a Danish cardiology unit.Patients ≥ 18 years capable of self-administering medication during hospitalization were eligible. Patients were excluded if they did not self-administer medication at home, were incapable of self-administering medication, were not prescribed medication suitable for self-administration, did not bring their medication, or were unable to speak Danish.Feasibility was assessed as part of the pilot study. A future randomized controlled trial was considered feasible if it was possible to recruit 60 patients within 3 months, if outcome measurement method was capable of detecting dispensing errors in both groups, and if patients in the intervention group were more satisfied with the medication management during hospitalization compared to the control group.Forty patients were recruited to gain experience about the intervention (self-administration). Additionally, 20 patients were randomized to the intervention or control group (nurse-led dispensing) to gain experience about the randomization procedure.Dispensing error proportions were based on data collected through disguised observation of patients and nurses during dispensing. The error proportion in the control group was used for the sample size calculation. Patient acceptability was assessed through telephone calls.
Results


Of the 60 patients recruited, one withdrew and 11 were discharged before observation resulting in analysis of 39 patients in the intervention group and nine in the control group. A dispensing error proportion of 3.4% was found in the intervention group and 16.1% in the control group. A total of 91.7% of patients in the intervention group and 66.7% in the control group were highly satisfied with the medication management during hospitalization. The overall protocol worked as planned. Minor changes in exclusion criteria, intervention, and outcome measures were considered.
Conclusions


It may be feasible to perform a pragmatic randomized controlled trial of the safety and cost-consequences of self-administration of medication during hospitalization.
Trial registration


ClinicalTrials.gov, NCT03541421, retrospectively registered on 30 May 2018.",2020,A dispensing error proportion of 3.4% was found in the intervention group and 16.1% in the control group.,"['20 patients', '60 patients within 3 months', 'Forty patients were recruited to gain experience about the intervention (self-administration', 'Patients were excluded if they did not self-administer medication at home, were incapable of self-administering medication, were not prescribed medication suitable for self-administration, did not bring their medication, or were unable to speak Danish', 'Patients ≥ 18\u2009years capable of self-administering medication during hospitalization were eligible']","['intervention or control group (nurse-led dispensing) to gain experience about the randomization procedure', '\n\n\nSelf-administration of medication (SAM', 'Self-administration of medication']",['Patient acceptability'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0564216', 'cui_str': 'Unable to speak'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0824047,A dispensing error proportion of 3.4% was found in the intervention group and 16.1% in the control group.,"[{'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Olesen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Enemark', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'de Thurah', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00665-3']
1848,32821423,Exploring community perceptions in preparation for a randomised controlled trial of biofortified flour in Pakistan.,"Background


Biofortification of staple food crops may be a cost-effective and sustainable approach to reducing micronutrient deficiencies in resource-poor settings with low dietary diversity. However, its success depends on uptake by the local population. This paper presents formative research conducted in a remote, rural community in North West Pakistan, prior to commencing a randomised controlled trial to test the effectiveness of consuming zinc-biofortified wheat flour for alleviating zinc deficiency. It explored local community members' knowledge, understanding and attitudes towards biofortification and views on members of their community taking part in the trial.
Methods


Four focus group discussions were conducted with male and female community members (separately for cultural reasons) and four in-depth interviews were conducted with Jirga members-respected male elders. Participation was limited to households that were ineligible for the trial so that we could explore the perspectives of community members who were not influenced by the incentives of the trial. Focus group participants were selected at community events for transparency. Data collection took place at the local school and homes of Jirga members. Thematic analysis was undertaken, using a combination of deductive and inductive approaches to identify key themes.
Results


A total of 47 men and women participated in this study. Participants reported clear motivation to access and consume more nutritious flour, believing this would bring health benefits, particularly to women and children. Trusted members of the local community, including Jirga members and female health workers, should be involved in providing information on biofortified flour (and the trial) to increase levels of awareness and acceptance. Without their involvement, there is a risk that biofortified flour would be mistrusted. The cost of flour is the main factor affecting purchasing decisions, and biofortified flour will need to be cost-competitive to achieve widespread uptake in marginalised, rural communities.
Conclusion


This formative study generated rich, qualitative data from a range of community stakeholders to improve the understanding of important barriers and facilitators to the widespread acceptability and adoption of biofortified wheat. Implementation research such as this will inform future decision-making in relation to scaling up biofortified wheat in Pakistan.",2020,"Trusted members of the local community, including Jirga members and female health workers, should be involved in providing information on biofortified flour (and the trial) to increase levels of awareness and acceptance.","['male and female community members (separately for cultural reasons) and four in-depth interviews were conducted with Jirga members-respected male elders', 'in Pakistan', 'Trusted members of the local community, including Jirga members and female health workers', '47 men and women participated in this study', 'remote, rural community in North West Pakistan']","['biofortified flour', 'consuming zinc-biofortified wheat flour']",[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}]","[{'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}]",[],47.0,0.0817448,"Trusted members of the local community, including Jirga members and female health workers, should be involved in providing information on biofortified flour (and the trial) to increase levels of awareness and acceptance.","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Mahboob', 'Affiliation': 'Khyber Medical University, Phase V, Hayatabad, Peshawar, Khyber Pakhtunkhwa Pakistan.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ohly', 'Affiliation': 'University of Central Lancashire, Preston, Lancashire PR1 2HE UK.'}, {'ForeName': 'Edward J M', 'Initials': 'EJM', 'LastName': 'Joy', 'Affiliation': 'London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Moran', 'Affiliation': 'University of Central Lancashire, Preston, Lancashire PR1 2HE UK.'}, {'ForeName': 'Mukhtiar', 'Initials': 'M', 'LastName': 'Zaman', 'Affiliation': 'Rehman Medical College, 5-B/2, Phase-V, Hayatabad, Peshawar, Khyber Pakhtunkhwa Pakistan.'}, {'ForeName': 'Nicola M', 'Initials': 'NM', 'LastName': 'Lowe', 'Affiliation': 'University of Central Lancashire, Preston, Lancashire PR1 2HE UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00664-4']
1849,32821459,"The Effect of the Modified Thoracolumbar Interfacial Nerve Plane Block on Postoperative Analgesia and Healing Quality in Patients Undergoing Lumbar Disk Surgery: A Prospective, Randomized Study.","Objective


The purpose of this study was to investigate the effect of the modified thoracolumbar interfascial plane block (TLIP) on postoperative analgesia and quality of recovery in patients undergoing lumbar disk surgery.
Method


Ninety patients scheduled for lumbar disk surgery were divided into a control group (Group C) and a modified TLIP block group (Group T). Controlled analgesia was administered to both groups. Pain evaluation was performed at 30 min and at 1., 2., 4., 8.,12., and 24. hrs using a VAS scale, with patients at rest and duringand patients completed the QoR-40 quality of recovery inventory.
Results


Fentanyl used during postoperative 24 hours was 742.5±220.3 mcg in Group C and 446.0±241.98 in Group T. Postoperative fentanyl consumption was statistically significantly lower in Group T (p<0.001) with a statistically significant intergroup difference. The patient's pain, physical independence, physical comfort, psychological support, and emotional support were compared using the QoR-40 questionnaire survey. Significant differences in favor of Group T were observed (p<0.001, p=0.017, p=0.002, p=0.001 and p<0.001, respectively). Static and dynamic pain scores in Group C and Group T were recorded at 30 min and at 1, 2, 4, 8, 12, and 24 h . Mean static scores were statistically significantly different in favor of Group T with the exception of 8 th  and 12 h  assessments (p<0.05). Dynamic scores were statistically significantly different in favor of Group T at all time points (p<0.05).
Conclusion


Pain scores, opioid consumption and QoR-40 values after lumbar disk surgery were superior in the group undergoing TLIP. We think that the modified TLIP block may be an important method in terms of postoperative analgesia and patient recovery for lumbar spinal disk surgery.",2019,Group T. Postoperative fentanyl consumption was statistically significantly lower in Group T (p<0.001) with a statistically significant intergroup difference.,"['Patients Undergoing Lumbar Disk Surgery', 'Method\n\n\nNinety patients scheduled for lumbar disk surgery', 'patients undergoing lumbar disk surgery']","['Modified Thoracolumbar Interfacial Nerve Plane Block', 'modified thoracolumbar interfascial plane block (TLIP', 'modified TLIP block']","[""patient's pain, physical independence, physical comfort, psychological support, and emotional support"", 'Postoperative fentanyl consumption', 'Mean static scores', 'QoR-40 quality of recovery inventory', 'Postoperative Analgesia and Healing Quality', 'Static and dynamic pain scores', 'Dynamic scores', 'Pain scores, opioid consumption and QoR-40 values', 'Pain evaluation', 'postoperative analgesia and quality of recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",90.0,0.052138,Group T. Postoperative fentanyl consumption was statistically significantly lower in Group T (p<0.001) with a statistically significant intergroup difference.,"[{'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Ozmen', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aksoy', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Aysenur', 'Initials': 'A', 'LastName': 'Dostbil', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Atalay', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Kamber', 'Initials': 'K', 'LastName': 'Kasali', 'Affiliation': 'Ataturk University, School of Medicine, Department of Biostatistics, Erzurum, Turkey.'}]",Medeniyet medical journal,['10.5222/MMJ.2019.36776']
1850,32821460,Comparison of General Anesthesia with Spinal Anesthesia in Laparoscopic Cholecystectomy Operations.,"Objective


Laparoscopic cholecystectomy (LC) operations are being performed under general anesthesia (GA). Further studies are needed on the issue whether these operations can be performed under spinal anesthesia (SA). In this study we aimed to compare SA with (GA) in terms of efficacy and complications in patients who will undergo LC operations, and to investigate the effects of preemptive analgesia on the development of shoulder pain, transition to general anesthesia, and postoperative analgesia.
Method


Sixty patients in ASA I-II risk group between 18-65 years of age undergoing laparoscopic cholecystectomy were randomly divided into general anesthesia (GA, n=30) and spinal anesthesia (SA, n=30) groups. Patients were premedicated with i.v. midazolam and fentanyl preoperatively. Anesthesia was induced with propofol in the GA group, and maintained with Desflurane and remifentanil. In the SA group, spinal anesthesia was provided with intratechal administration of 15 mg bupivacaine at L2-3 level, and block level was increased to T4 by keeping the patient in Trendelenburg position for 7-10 minutes. Demographic data, hemodynamic parameters, operation time, visual analog scale (VAS) scores at postoperative 0 th ,1 st , 4 th , 8 th ,12 th  and 24 th  hours, patient-surgeon satisfaction, side effects, and occurrence of right shoulder pain in SA group were inquired and recorded.
Results


Effective anesthesia was produced in both groups. Hypotension was observed in 5, bradycardia requiring atropin administration in 4, and perioperative shoulder pain in 9 patients in Group SA, but none of them required general anesthesia. Hypotension developed in one patient in Group GA. The postoperative VAS scores were significantly lower in Group SA at 0 th ,1 st , 4 th  hours. Patient satisfection scores were higher in Group SA.
Conclusion


We concluded that spinal anesthesia may be an alternative method to general anesthesia in patients who will undergo laparoscopic cholecystectomy operations especially when the risk of general anesthesia is too high.",2019,"The postoperative VAS scores were significantly lower in Group SA at 0 th ,1 st , 4 th  hours.","['patients who will undergo LC operations', 'patients who will undergo laparoscopic cholecystectomy operations', 'Method\n\n\nSixty patients in ASA I-II risk group between 18-65 years of age undergoing laparoscopic cholecystectomy', 'Laparoscopic Cholecystectomy Operations']","['propofol', 'bupivacaine', 'General Anesthesia with Spinal Anesthesia', 'general anesthesia (GA, n=30) and spinal anesthesia', 'Desflurane and remifentanil', 'midazolam', 'SA with (GA', 'Laparoscopic cholecystectomy (LC) operations']","['efficacy and complications', 'Demographic data, hemodynamic parameters, operation time, visual analog scale (VAS) scores', 'Patient satisfection scores', 'postoperative VAS scores', 'perioperative shoulder pain', 'Hypotension', 'patient-surgeon satisfaction, side effects, and occurrence of right shoulder pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0241040', 'cui_str': 'Pain of right shoulder joint'}]",,0.0185863,"The postoperative VAS scores were significantly lower in Group SA at 0 th ,1 st , 4 th  hours.","[{'ForeName': 'Alperen', 'Initials': 'A', 'LastName': 'Kisa', 'Affiliation': 'Hitit University Erol Olcok Education and Research Hospital, Department Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Koruk', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Kocoglu', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'İhsan Metin', 'Initials': 'İM', 'LastName': 'Leblebici', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Training and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}]",Medeniyet medical journal,['10.5222/MMJ.2019.37929']
1851,32821465,Effects of Bispectral Index-controlled Use of Magnesium on Propofol Consumption and Sedation Level in Patients Undergoing Colonoscopy.,"Objective


The aim of this study is to investigate the effects of bispectral index-controlled use of magnesium on propofol consumption, periprocedural hemodynamic response and patient comfort.
Material


A total of 60 patients were enrolled in the study. In Group 1 (magnesium), a single dose 50 mg/kg magnesium sulfate diluted with 100 mL 0.9% NaCl was administered 10 minutes before the beginning of the procedure. Initially bolus dose of 0.5 mg/kg propofol was applied. The maintenance dose of propofol was 60 mcg/kg/min. During the procedure, the propofol infusion was increased by titration until the bispectral index (BIS) value of 70 was achieved. In Group 2 (saline), 100 ml 0.9% NaCl was administered 10 minutes before the beginning of the procedure. The bolus and maintenance doses of propofol, and target BIS values were the same as those in Group 1.
Results


When BIS values were compared between the groups, the initial BIS values in the magnesium group (Group 1) were significantly higher than those of the saline group (Group 2) (p<0.05). The time to reach BIS 70 was significantly shorter in the magnesium group (p<0.05). Propofol consumption was greater in Group 2 than in Group 1 (p<0.05). The time to reach BIS 70 was significantly shorter in Group 1 (p<0.05). No significant difference was found between the groups in terms of patient- and endoscopist-satisfaction (p<0.05).
Conclusion


The use of magnesium in addition to propofol may be an efficient and reliable option to reduce the drug consumption during colonoscopic interventions.",2019,The time to reach BIS 70 was significantly shorter in the magnesium group (p<0.05).,"['Patients Undergoing Colonoscopy', '60 patients were enrolled in the study']","['Magnesium', 'Material', 'magnesium sulfate diluted with 100 mL 0.9% NaCl', 'propofol', 'magnesium']","['Propofol consumption', 'titration until the bispectral index (BIS) value', 'patient- and endoscopist-satisfaction (p<0.05', 'initial BIS values', 'time to reach BIS', 'Propofol Consumption and Sedation Level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0513658,The time to reach BIS 70 was significantly shorter in the magnesium group (p<0.05).,"[{'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Yoldas', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Yildiz', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Karagoz', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sit', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of General Surgery, Bolu, Turkey.'}, {'ForeName': 'Muhammed Nur', 'Initials': 'MN', 'LastName': 'Ogun', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Neurology, Bolu, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirhan', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bilgi', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}]",Medeniyet medical journal,['10.5222/MMJ.2019.99705']
1852,32821494,Histologic Changes Following Continuous Wave and Micropulse Transscleral Cyclophotocoagulation: A Randomized Comparative Study.,"Purpose


To compare the macroscopic and microscopic histologic changes in eyes treated with micropulse transscleral cyclophotocoagulation (MP-TCP) versus continuous wave transscleral cyclophotocoagulation (CW-TCP).
Methods


Twelve halves of globes from three pairs of adult cadaveric eyes were randomly assigned to nontreated control, CW-TCP, single MP-TCP treatment, or double MP-TCP treatments, and then sectioned for histologic analysis. Presence or absence of the following four unique histologic changes was recorded: splitting within the ciliary process epithelium (splitting), separation of the pigmented ciliary process epithelium from the stroma (separation), coagulation of collagen and destruction of ciliary process stroma (coagulation), and full-thickness destruction of ciliary process epithelium (destruction).
Results


A total of 498 slides were analyzed, and laser scars in all treated specimens were located in the pars plana. Logistic regression analysis showed that compared with controls, CW-TCP-treated specimens were significantly more likely to experience separation (odds ratio [OR] = 11.1,  P  = 0.02), coagulation (OR = 24.3,  P  = 0.002), and destruction (OR = 11.1,  P  = 0.03). Destruction of the ciliary process epithelium was observed exclusively in CW-TCP-treated sections. No significant differences in histologic features were observed between controls and MP-TCP.
Conclusions


MP-TCP does not produce significant histologic changes in cadaveric eyes, whereas CW-TCP treatment does.
Translational Relevance


These findings improve understanding of the mechanism of MP-TCP, help explain the increased rates of adverse effects following CW-TCP treatment compared with MP-TCP, and describe effects of MP-TCP at various doses.",2020,"Logistic regression analysis showed that compared with controls, CW-TCP-treated specimens were significantly more likely to experience separation (odds ratio [OR] = 11.1,  P  = 0.02), coagulation (OR = 24.3,  P  = 0.002), and destruction (OR = 11.1,  P  = 0.03).","['eyes treated with', 'Methods\n\n\nTwelve halves of globes from three pairs of adult cadaveric eyes']","['Continuous Wave and Micropulse Transscleral Cyclophotocoagulation', 'micropulse transscleral cyclophotocoagulation (MP-TCP) versus continuous wave transscleral cyclophotocoagulation (CW-TCP', 'CW-TCP', 'nontreated control, CW-TCP, single MP-TCP treatment, or double MP-TCP treatments']","['Destruction of the ciliary process epithelium', 'Histologic Changes', 'histologic features', 'coagulation', 'macroscopic and microscopic histologic changes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0395490', 'cui_str': 'Photocoagulation of ciliary body'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C1261761', 'cui_str': 'Structure of ciliary processes'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]",498.0,0.0289074,"Logistic regression analysis showed that compared with controls, CW-TCP-treated specimens were significantly more likely to experience separation (odds ratio [OR] = 11.1,  P  = 0.02), coagulation (OR = 24.3,  P  = 0.002), and destruction (OR = 11.1,  P  = 0.03).","[{'ForeName': 'Kareem', 'Initials': 'K', 'LastName': 'Moussa', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Feinstein', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Pekmezci', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jun Hui', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bloomer', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}]",Translational vision science & technology,['10.1167/tvst.9.5.22']
1853,32821503,Biofeedback Rehabilitation and Visual Cortex Response in Stargardt's Disease: A Randomized Controlled Trial.,"Purpose


to evaluate the effect of biofeedback (BF) rehabilitation on the visual function and on the activity of primary visual cortex (PVC) in patients with Stargardt's disease owing to mutations in the  ABCA4  gene (STGD1).
Methods


This was a single-center, controlled, randomized study. Twenty-four patients with STGD1 were randomized into two groups: a treatment group (TG) undergoing BF rehabilitation and a control group (CG). Treatment with BF consisted of a 10-minute session per eye performed weekly for 12 weeks. The subjects underwent a baseline and 3-month follow-up visits, including best-corrected visual acuity (BCVA), reading test, microperimetry, and functional magnetic resonance imaging (fMRI). The fMRI studies were acquired sequentially using a passive viewing condition and an active reading task. The primary outcomes were the change in the fMRI activation of primary visual cortex and the change in reading ability.
Results


After treatment, the patients in the TG were able to read smaller characters ( P  = 0.002) with a greater reading speed ( P  = 0.014) compared with patients in the CG. The fMRI studies showed a significant effect ( P  < 0.001) of BF on primary visual cortex activation in the TG compared with the CG. Finally, we observed significant ( P  < 0.05) improvements of best-corrected visual acuity, macular sensitivity, and fixation stability parameters in the TG compared with the CG.
Conclusions


Our study showed that visual rehabilitation using BF improved the usage of residual visual function in patients with STGD1.
Translational Relevance


Our findings show that the BF treatment compared with no treatment at all resulted in benefits. The specificity of the treatment could be examined to determine whether BF can be included in clinical practice.",2020,The fMRI studies showed a significant effect ( P  < 0.001) of BF on primary visual cortex activation in the TG compared with the CG.,"['patients with STGD1', ""Stargardt's Disease"", 'Twenty-four patients with STGD1', ""patients with Stargardt's disease owing to mutations in the  ABCA4  gene (STGD1""]","['treatment group (TG) undergoing BF rehabilitation and a control group (CG', 'biofeedback (BF) rehabilitation']","['best-corrected visual acuity, macular sensitivity, and fixation stability parameters', 'best-corrected visual acuity (BCVA), reading test, microperimetry, and functional magnetic resonance imaging (fMRI', 'residual visual function', 'Biofeedback Rehabilitation and Visual Cortex Response', 'fMRI activation of primary visual cortex and the change in reading ability', 'primary visual cortex activation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1855465', 'cui_str': 'Macular Dystrophy With Flecks, Type 1'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0038446', 'cui_str': 'Area striata structure'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0586739', 'cui_str': 'Ability to read'}]",24.0,0.0587559,The fMRI studies showed a significant effect ( P  < 0.001) of BF on primary visual cortex activation in the TG compared with the CG.,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Melillo', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Prinster', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Naples, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Iorio', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Olivo', 'Affiliation': 'Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Francesco Maria', 'Initials': 'FM', 'LastName': ""D'Alterio"", 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Sirio', 'Initials': 'S', 'LastName': 'Cocozza', 'Affiliation': 'Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Quarantelli', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Testa', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Brunetti', 'Affiliation': 'Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Simonelli', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}]",Translational vision science & technology,['10.1167/tvst.9.6.6']
1854,32821675,Comparative 2-year outcomes of conventional and accelerated corneal collagen crosslinking in progressive keratoconus.,"AIM


To compare the safety and efficacy of conventional versus accelerated (9 mW/cm 2 ) corneal collagen crosslinking (CXL) in progressive keratoconus at the 2-year follow-up.
METHODS


In this prospective study, consecutive progressive keratoconus patients were randomized to receive either conventional CXL (CCXL) or accelerated CXL (ACXL; using hydroxypropyl methylcellulose-assisted riboflavin imbibition for 10min at 9 mW/cm 2 ). Visual, refractive, keratometric, topographic, and aberrometric outcomes and stromal demarcation line depth (DLD) measurements were compared at the end of a 2-year follow-up.
RESULTS


Thirty-two eyes from 32 patients in the CCXL and 27 eyes from 27 patients in the ACXL groups completed 2-year follow-up. At 2y post-CXL, both uncorrected and corrected visual acuities improved significantly in both groups. The improvements in keratometric readings, flattening rate (flattening of the maximum keratometry more than 1 D), 3 topographic indices, and vertical coma were significantly better in the CCXL group compared to the ACXL group ( P <0.05). The DLD as measured by anterior segment optical coherence tomography or  in vivo  confocal microscopy was better detectable and significantly deeper in the CCXL group compared to the ACXL group. The deeper DLD was found to be significantly correlated with improvements in the mean keratometry measurements. Progression was noted in 11.1% of eyes in the ACXL group, whereas progression was not observed in any patient eye in the CCXL group.
CONCLUSION


In this prospective randomized study, ACXL is less effective in halting the progression of keratoconus at a 2-year follow-up compared to CCXL.",2020,"Progression was noted in 11.1% of eyes in the ACXL group, whereas progression was not observed in any patient eye in the CCXL group.
","['progressive keratoconus', 'consecutive progressive keratoconus patients', 'Thirty-two eyes from 32 patients in the CCXL and 27 eyes from 27 patients in the ACXL groups completed 2-year follow-up']","['conventional CXL (CCXL) or accelerated CXL (ACXL; using hydroxypropyl methylcellulose-assisted riboflavin imbibition', 'CCXL', 'conventional versus accelerated (9 mW/cm 2 ) corneal collagen crosslinking (CXL', 'conventional and accelerated corneal collagen crosslinking', 'ACXL']","['keratometric readings, flattening rate (flattening of the maximum keratometry', 'corrected visual acuities', 'safety and efficacy', 'Progression', 'Visual, refractive, keratometric, topographic, and aberrometric outcomes and stromal demarcation line depth ', 'topographic indices, and vertical coma']","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0009421', 'cui_str': 'Coma'}]",32.0,0.029813,"Progression was noted in 11.1% of eyes in the ACXL group, whereas progression was not observed in any patient eye in the CCXL group.
","[{'ForeName': 'Ömür Ö', 'Initials': 'ÖÖ', 'LastName': 'Uçakhan', 'Affiliation': 'Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara 06550, Turkey.'}, {'ForeName': 'Yağmur Seda', 'Initials': 'YS', 'LastName': 'Yeşiltaş', 'Affiliation': 'Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara 06550, Turkey.'}]",International journal of ophthalmology,['10.18240/ijo.2020.08.07']
1855,32821700,Effect of Niacin on Carotid Atherosclerosis in Patients at Low-Density Lipoprotein-Cholesterol Goal but High Lipoprotein (a) Level: a 2-Year Follow-Up Study.,"Objective


To examine the effect of niacin on the progression of carotid intima-media thickness (IMT) in patients with high level of lipoprotein (Lp) (a).
Methods


Patients at low-density lipoprotein-cholesterol goal but with Lp (a) >25 mg/dL and mean carotid IMT >0.75 mm were included. Eligible patients were randomized at a 1:2 ratio into one of two groups for 24 months: control or 1,500 mg extended release niacin. The primary study outcomes were the percentage changes in mean and maximal carotid IMT. The percentage change in lipid profiles including Lp (a) was analyzed as a secondary study outcome.
Results


Among 96 randomized patients, 31 completed the study (mean age: 65 years; male: 44%). At follow-up, the percentage change in mean carotid IMT was not significantly different between the two groups (-1.4%±15.5% and -1.1%±7.3% in the control and niacin groups, respectively,  p =0.95). The percentage change in maximal carotid IMT was also similar in the two groups (0.7%±16.5% and -4.4%±11.6%, respectively,  p =0.35). Elevation of high-density lipoprotein-cholesterol tended to be higher in the niacin group ( p =0.07), and there was a significant difference in the percentage change in hemoglobin A1c between the two groups (-1.9%±2.2% and 3.3%±6.7%, respectively,  p =0.02). Reduction of Lp (a) was greater in the niacin-treated group compared to placebo, but the difference was not statistically significant.
Conclusion


Treatment with niacin for two years did not inhibit the progression of carotid intima-media thickening in patients with high Lp (a) level. However, this study may have been underpowered to evaluate the primary study outcome.",2019,"Elevation of high-density lipoprotein-cholesterol tended to be higher in the niacin group ( p =0.07), and there was a significant difference in the percentage change in hemoglobin A1c between the two groups (-1.9%±2.2% and 3.3%±6.7%, respectively,  p =0.02).","['Methods\n\n\nPatients at low-density lipoprotein-cholesterol goal but with Lp (a) >25 mg/dL and mean carotid IMT >0.75 mm were included', 'patients with high level of lipoprotein (Lp) (a', 'Patients at Low-Density Lipoprotein-Cholesterol Goal but High Lipoprotein', '96 randomized patients, 31 completed the study (mean age: 65 years; male: 44', 'Eligible patients']","['placebo', 'Niacin', 'niacin', 'control or 1,500 mg extended release niacin']","['hemoglobin A1c', 'Elevation of high-density lipoprotein-cholesterol', 'percentage changes in mean and maximal carotid IMT', 'Reduction of Lp (a', 'maximal carotid IMT', 'progression of carotid intima-media thickness (IMT', 'Carotid Atherosclerosis', 'progression of carotid intima-media thickening', 'mean carotid IMT']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}]",96.0,0.192089,"Elevation of high-density lipoprotein-cholesterol tended to be higher in the niacin group ( p =0.07), and there was a significant difference in the percentage change in hemoglobin A1c between the two groups (-1.9%±2.2% and 3.3%±6.7%, respectively,  p =0.02).","[{'ForeName': 'Shinjeong', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chan Joo', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Department of Health Promotion, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jaewon', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seok-Min', 'Initials': 'SM', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Hak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of lipid and atherosclerosis,['10.12997/jla.2019.8.1.58']
1856,32821711,Intensity of Statin Treatment in Korean Patients with Acute Myocardial Infarction and Very Low LDL Cholesterol.,"Objective


Data on the intensity of statin therapy for patients with acute myocardial infarction (MI) and very low baseline low-density lipoprotein (LDL) cholesterol level are lacking. We sought to assess the impact of statin intensity in patients with acute MI and LDL cholesterol <70 mg/dL.
Methods


A total of 1,086 patients with acute MI and baseline LDL cholesterol <70 mg/dL from the Korea Acute Myocardial Infarction Registry-National Institute of Health database were divided into less intensive statin (expected LDL reduction <40%, n=302) and more intensive statin (expected LDL reduction ≥40%, n=784) groups. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, MI, revascularization occurring at least 30 days after admission, and stroke, at 12 months.
Results


After 1:2 propensity matching, differences were not observed between less intensive (n=302) and more intensive statin (n=604) groups in incidence of cardiac death (0.3% vs. 0.3%) and hemorrhagic stroke (0.3% vs. 0.5%,  p =0.727) at 12 months. Compared with the less intensive statin group, the more intensive statin group showed lower target-vessel revascularization (4.6% vs. 1.8%,  p =0.027) and MACCE (11.6% vs. 7.0%,  p =0.021). Major bleeding was not different between less intensive and more intensive statin groups (1.0% vs. 2.6%,  p =0.118).
Conclusion


More intensive statin therapy was associated with significantly lower major adverse cardiovascular events in patients with acute MI and very low LDL cholesterol compared with less intensive statin therapy.",2019,"Major bleeding was not different between less intensive and more intensive statin groups (1.0% vs. 2.6%,  p =0.118).
","['Korean Patients with Acute Myocardial Infarction and Very Low LDL Cholesterol', 'patients with acute myocardial infarction (MI) and very low baseline low-density lipoprotein (LDL) cholesterol level are lacking', 'patients with acute MI and LDL cholesterol', 'patients with acute MI', '1,086 patients with acute MI and baseline LDL cholesterol <70 mg/dL from the Korea Acute Myocardial Infarction Registry-National Institute of Health database were divided into less intensive statin (expected LDL reduction <40%, n=302) and more intensive statin (expected LDL reduction ≥40%, n=784) groups']",['statin therapy'],"['hemorrhagic stroke', 'target-vessel revascularization', 'incidence of cardiac death', 'MACCE', 'major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, MI, revascularization occurring at least 30 days after admission, and stroke, at 12 months', 'Major bleeding']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",1086.0,0.0522134,"Major bleeding was not different between less intensive and more intensive statin groups (1.0% vs. 2.6%,  p =0.118).
","[{'ForeName': 'Doo Sun', 'Initials': 'DS', 'LastName': 'Sim', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Hyo Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Hyeon Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Department of Cardiology, Seoul Samsung Medical Center, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Ki Bae', 'Initials': 'KB', 'LastName': 'Seung', 'Affiliation': 'Department of Cardiology, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Seung Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'The Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Shung Chull', 'Initials': 'SC', 'LastName': 'Chae', 'Affiliation': 'Department of Cardiology, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Chong Jin', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, Korea.'}, {'ForeName': 'Kwang Soo', 'Initials': 'KS', 'LastName': 'Cha', 'Affiliation': 'Department of Cardiology, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'Jong Seon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Yeungnam University Hospital, Daegu, Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Korea.'}, {'ForeName': 'Jei Keon', 'Initials': 'JK', 'LastName': 'Chae', 'Affiliation': 'Department of Cardiology, Chunbuk National University Hospital, Jeonju, Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Joo', 'Affiliation': 'Department of Cardiology, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Dong Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Seung Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Medical Center, Daegu, Korea.'}, {'ForeName': 'In Whan', 'Initials': 'IW', 'LastName': 'Seong', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Myeong Chan', 'Initials': 'MC', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiology, Chungbuk National University Hospital, Cheongju, Korea.'}, {'ForeName': 'Doo Il', 'Initials': 'DI', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Inje University Haeundae Paik Hospital, Busan, Korea.'}, {'ForeName': 'Seok Kyu', 'Initials': 'SK', 'LastName': 'Oh', 'Affiliation': 'Department of Cardiology, Wonkwang University Hospital, Iksan, Korea.'}, {'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Jin Yong', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Division of Cardiology, Gyungsang National University Hospital, Jinju, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of lipid and atherosclerosis,['10.12997/jla.2019.8.2.208']
1857,32821712,Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial.,"Objective


The aim of this study was to investigate the effects of omega-3 fatty acids added to statin monotherapy in Korean patients with type 2 diabetes who have persistent hypertriglyceridemia despite statin therapy.
Methods


This study was a randomized controlled trial conducted in 4 clinical sites between February 2009 and February 2011. The inclusion criteria were patients with type 2 diabetes who had received ≥6 weeks of statin therapy and had fasting triglyceride (TG) levels ≥1.7mmol/L and low-density lipoprotein (LDL) cholesterol levels <2.6 mmol/L. The study regimen consisted of 16 weeks of randomized treatment with omega-3 fatty acids (4 g/day) plus a statin (n=26) or statin only (n=30). The primary endpoint was the change from baseline to final visit in mean TG level.
Results


A total of 56 participants were analyzed. At week 16, the change in the TG level in the combination therapy group differed significantly from the change in the statin monotherapy group (-34.8% vs. -15.2%,  p =0.0176). Treatment with omega-3 fatty acids plus a statin was also associated with a significant decrease in non-high-density lipoprotein cholesterol compared with baseline, but the difference was not significant compared with the statin monotherapy group (-8.0% vs. -2.5%,  p =0.165). The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups. The study medications were well tolerated, and adverse events were comparable between two groups.
Conclusion


Adding omega-3 fatty acids to statin treatment reduced TG levels more effectively than statin monotherapy without undesirable effects in Korean type 2 diabetic patients who had hypertriglyceridemia despite well-controlled LDL cholesterol on stable statin therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02305355.",2019,The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups.,"['patients with type 2 diabetes who had received ≥6 weeks of statin therapy and had', 'Korean type 2 diabetic patients who had hypertriglyceridemia despite well-controlled LDL cholesterol on stable statin therapy', 'Korean Patients with Type 2 Diabetes and Hypertriglyceridemia', 'Korean patients with type 2 diabetes who have persistent hypertriglyceridemia despite statin therapy', '4 clinical sites between February 2009 and February 2011', 'A total of 56 participants were analyzed']","['omega-3 fatty acids', 'Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy', 'statin (n=26) or statin', 'statin monotherapy']","['LDL cholesterol and HbA1c levels', 'non-high-density lipoprotein cholesterol', 'TG level', 'change from baseline to final visit in mean TG level', 'fasting triglyceride (TG) levels ≥1.7mmol/L and low-density lipoprotein (LDL) cholesterol levels', 'tolerated, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",56.0,0.103999,The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups.,"[{'ForeName': 'Jang Won', 'Initials': 'JW', 'LastName': 'Son', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.""}, {'ForeName': 'Chul-Hee', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Mun Suk', 'Initials': 'MS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Ie Byung', 'Initials': 'IB', 'LastName': 'Park', 'Affiliation': 'Department of Endocrinology, Gachon University of Medicine and Science, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Soon Jib', 'Initials': 'SJ', 'LastName': 'Yoo', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.""}]",Journal of lipid and atherosclerosis,['10.12997/jla.2019.8.2.221']
1858,32821729,Efficacy and Safety of High-Dose Atorvastatin in Moderate-to-High Cardiovascular Risk Postmenopausal Korean Women with Dyslipidemia.,"Objective


Postmenopausal women show a more atherogenic lipid profile and elevated cardiovascular risk compared to premenopausal women. The aim of this study was to investigate the efficacy and safety of high-dose atorvastatin on the improvement of the blood lipid profile of postmenopausal women in Korea.
Methods


This study is a prospective, open-label, single-arm clinical trial that was conducted in 3 teaching hospitals. Postmenopausal women with a moderate-to-high cardiovascular risk, according to guidelines from the Korean Society of Lipid & Atherosclerosis, were enrolled. Participants were administered 20 mg of atorvastatin daily for the first 8 weeks, and if the targeted low-density lipoprotein cholesterol (LDL-C) level was not achieved, the dose was increased to 40 mg for the second 8 weeks. The primary endpoint was percentage change of LDL-C from baseline after 16 weeks of drug administration.
Results


Forty-four women were enrolled, 28 of whom (75.6%) had diabetes mellitus. By the end of treatment period (16 weeks) all patients had achieved LDL-C target levels, with 33 (94.2%) of the participants achieving it after only 8 weeks of administration. After 16 weeks, LDL-C decreased by 45.8±16.7% ( p <0.001) from the baseline, and total cholesterol (33.2±10.9%;  p <0.001), triglyceride (24.2±37.5%;  p =0.001), and apolipoprotein B (34.9±15.6%;  p <0.001) also significantly decreased. Blood glucose and liver enzyme levels slightly increased, but none of the participants developed serious adverse events that would cause them to prematurely withdraw from the clinical trial.
Conclusion


20 and 40 mg atorvastatin was effective and safe for treating dyslipidemia in postmenopausal Korean women with moderate-to-high cardiovascular risk.",2020,"After 16 weeks, LDL-C decreased by 45.8±16.7% ( p <0.001) from the baseline, and total cholesterol (33.2±10.9%;  p <0.001), triglyceride (24.2±37.5%;  p =0.001), and apolipoprotein B (34.9±15.6%;  p <0.001) also significantly decreased.","['3 teaching hospitals', 'postmenopausal women in Korea', 'postmenopausal Korean women with moderate-to-high cardiovascular risk', 'Moderate-to-High Cardiovascular Risk Postmenopausal Korean Women with Dyslipidemia', 'Results\n\n\nForty-four women were enrolled, 28 of whom (75.6%) had diabetes mellitus', 'Postmenopausal women with a moderate-to-high cardiovascular risk, according to guidelines from the Korean Society of Lipid & Atherosclerosis, were enrolled', 'premenopausal women']","['atorvastatin', 'High-Dose Atorvastatin']","['Efficacy and Safety', 'percentage change of LDL-C', 'blood lipid profile', 'total cholesterol', 'atherogenic lipid profile and elevated cardiovascular risk', 'apolipoprotein B', 'LDL-C target levels', 'efficacy and safety', 'serious adverse events', 'triglyceride', 'density lipoprotein cholesterol (LDL-C) level', 'LDL-C', 'Blood glucose and liver enzyme levels']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}]",44.0,0.0767014,"After 16 weeks, LDL-C decreased by 45.8±16.7% ( p <0.001) from the baseline, and total cholesterol (33.2±10.9%;  p <0.001), triglyceride (24.2±37.5%;  p =0.001), and apolipoprotein B (34.9±15.6%;  p <0.001) also significantly decreased.","[{'ForeName': 'Jaecheol', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Gwanpyo', 'Initials': 'G', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Kyung-Wan', 'Initials': 'KW', 'LastName': 'Min', 'Affiliation': 'Department of Internal Medicine, Eulji Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Ho', 'Initials': 'HH', 'LastName': 'Shin', 'Affiliation': 'Department of Medicine/Cardiology, Cheil General Hospital, Seoul, Korea.'}]",Journal of lipid and atherosclerosis,['10.12997/jla.2020.9.1.162']
1859,32821737,Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin.,"Objective


The aim of this study was to investigate whether a new generic rosuvastatin is non-inferior to a proprietary one in terms of lipid-lowering efficacy. We also evaluated its non-lipid effects including adverse events.
Methods


One-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened. After a 4-week run-in period, 126 individuals who met the lipid criteria for drug therapy were randomly assigned to receive the new generic or proprietary rosuvastatin 10 mg daily for 8 weeks. The primary outcome variables were low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement. Hematological and biochemical parameters and adverse events were assessed.
Results


After 8 weeks of drug treatment, the mean percentage change in LDL-C was not different between the groups (-45.5%±19.9% and -45.1%±19.0% for generic and proprietary rosuvastatin, respectively;  p =0.38). The LDL-C target achievement rate was similar between the groups (75.0% and 77.1% for generic and proprietary rosuvastatin, respectively;  p =0.79). The percentage change in the other lipid profiles was not significantly different. Although generic- and proprietary rosuvastatins modestly affected creatine kinase and blood pressure, respectively, the changes were all within normal ranges. Incidence of adverse events did not differ between the receivers of the 2 formulations.
Conclusion


The new generic rosuvastatin was non-inferior to the proprietary rosuvastatin in terms of lipid-lowering efficacy. The rosuvastatin formulations did not exhibit clinically significant non-lipid effects with good safety profiles. Our study provides comprehensive data regarding 2 rosuvastatin formulations in East Asian subjects.
Trial Registration


ClinicalTrials.gov Identifier: NCT03949374.",2020,"Incidence of adverse events did not differ between the receivers of the 2 formulations.
","['East Asian subjects', 'Koreans', '126 individuals who met the lipid criteria for drug therapy', 'Methods\n\n\nOne-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened']","['new generic or proprietary rosuvastatin', 'rosuvastatin', 'New Generic Rosuvastatin', 'Proprietary Rosuvastatin']","['low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement', 'LDL-C target achievement rate', 'creatine kinase and blood pressure', 'Hematological and biochemical parameters and adverse events', 'Incidence of adverse events', 'mean percentage change in LDL-C']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",158.0,0.0482785,"Incidence of adverse events did not differ between the receivers of the 2 formulations.
","[{'ForeName': 'Hyoeun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Health Promotion, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chan Joo', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In-Cheol', 'Initials': 'IC', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Geu-Ru', 'Initials': 'GR', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In-Jeong', 'Initials': 'IJ', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Chi-Young', 'Initials': 'CY', 'LastName': 'Shim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Hak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of lipid and atherosclerosis,['10.12997/jla.2020.9.2.283']
1860,32821745,The Effect of Nano-Curcumin Supplementation on Pentraxin 3 Gene Expression and Serum Level in Migraine Patients.,"Background


This study was designed to investigate the effect of nano-curcumin supplementation on pentraxin 3 (PTX3) gene exp ression and serum level in migraine patients.
Methods


The present study, performed as a clinical trial, included 38 episodic migraine patients in two groups that received either nano-curcumin or placebo over a two-month period. At the start and the end of the study, PTX3 gene expression and serum levels were measured.
Results


After two months of treatment, PTX3 gene expression and serum levels were both significantly less in the nano-curcumin than in the placebo group (P= 0.01 and P< 0.001, respectively). No significant gene expression differences were found between the two groups.
Conclusion


Curcumin may have a potential inhibitory effect on PTX3 gene expression and serum levels in migraine disease and can be considered as an efficient therapy in migraine management.",2020,"After two months of treatment, PTX3 gene expression and serum levels were both significantly less in the nano-curcumin than in the placebo group (P= 0.01 and P< 0.001, respectively).","['Migraine Patients', '38 episodic migraine patients in two groups that received either', 'migraine patients']","['placebo', 'Nano-Curcumin Supplementation', 'nano-curcumin or placebo', 'nano-curcumin supplementation']","['PTX3 gene expression and serum levels', 'pentraxin 3 (PTX3) gene exp ression and serum level', 'Pentraxin 3 Gene Expression and Serum Level']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",38.0,0.043574,"After two months of treatment, PTX3 gene expression and serum levels were both significantly less in the nano-curcumin than in the placebo group (P= 0.01 and P< 0.001, respectively).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Abdolahi', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Heidari', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Faculty of Basic Sciences, Tehran Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Sadeghizadeh', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, Shahed University, Tehran, Iran.'}]",Reports of biochemistry & molecular biology,['10.29252/rbmb.9.1.1']
1861,32821805,"A Resident-Authored, Case-Based Electrocardiogram Email Curriculum for Internal Medicine Residents.","Introduction


The interpretation of electrocardiograms (ECGs) is a critical competency for internal medicine trainees, yet time and resources to foster proficiency are limited.
Methods


This resident-authored ECG email curriculum for first-year residents involved 129 first-year internal medicine residents at three major academic university hospitals. Residents either received the resident-authored ECG email curriculum (intervention group) or continued standard training (control group). The curriculum involved 10 multiple-choice ECG cases emailed biweekly over the 6-month study period. All participants were asked to complete a pre- and postintervention test to assess ECG interpretation competency and attitudes. The primary outcome was improvement in ECG test performance.
Results


Among the 129 first-year residents participating, 21 of the 65 (32%) randomized to the intervention group and 13 of the 64 (20%) randomized to the control group completed both the pre- and posttests for analysis. While all participants' ECG test scores improved over the study period ( p  < .001), improvement did not differ between groups ( p  = .860). We found that the effect of the intervention on ECG test performance varied significantly by the number of cardiology rotations an intern experienced ( p  = .031), benefiting naïve learners the most. All intervention group participants who completed the posttest reported they would recommend it to a colleague.
Discussion


While it did not improve resident performance on an ECG posttest, this resident-authored ECG email curriculum offers a scalable way to provide trainees additional practice with ECG interpretation, with particular benefit to trainees who have not yet rotated on cardiology.",2020,"Discussion


While it did not improve resident performance on an ECG posttest","['Among the 129 first-year residents participating, 21 of the 65 (32', 'first-year residents involved 129 first-year internal medicine residents at three major academic university hospitals']",['resident-authored ECG email curriculum (intervention group) or continued standard training (control group'],"['ECG posttest', 'ECG test scores', 'ECG test performance']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",129.0,0.0405118,"Discussion


While it did not improve resident performance on an ECG posttest","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Klein', 'Affiliation': 'Clinical Instructor, Division of General Internal Medicine, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Berlacher', 'Affiliation': 'Fellow, Department of Cardiology, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Doran', 'Affiliation': 'Fellow, Division of Cardiology, University of Rochester Medical Center.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Corbelli', 'Affiliation': 'Associate Professor of Medicine, Division of General Internal Medicine, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rothenberger', 'Affiliation': 'Assistant Professor of Medicine, Division of General Internal Medicine, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Berlacher', 'Affiliation': 'Assistant Professor of Medicine, Heart and Vascular Institute, University of Pittsburgh School of Medicine.'}]",MedEdPORTAL : the journal of teaching and learning resources,['10.15766/mep_2374-8265.10927']
1862,32821924,Association of Sex or Race With the Effect of Weight Loss on Physical Function: A Secondary Analysis of 8 Randomized Clinical Trials.,"Importance


Consideration of differential treatment effects among subgroups in clinical trial research is a topic of increasing interest. This is an especially salient issue for weight loss trials.
Objective


To determine whether stratification by sex and race is associated with meaningful differences in physical function response to weight loss among older adults.
Design, Setting, and Participants


This pooled analysis used individual-level data from 8 completed randomized clinical trials of weight loss conducted at Wake Forest University or Wake Forest School of Medicine, Winston-Salem, North Carolina. Data were housed within the Wake Forest Older Americans Independence Center data repository and provided complete exposure, outcome, and covariate information. Data were collected from November 1996 to March 30, 2017, and analyzed from August 15, 2019, to June 10, 2020.
Exposures


Treatment arms within each study were collapsed into caloric restriction (CR [n = 734]) and non-CR (n = 583) categories based on whether caloric restriction was specified in the original study protocol.
Main Outcomes and Measures


Objectively measured 6-month change in weight, fast-paced gait speed (meters per second), and Short Physical Performance Battery (SPPB) score.
Results


A total of 1317 adults (mean [SD] age, 67.7 [5.4] years; 920 [69.9%] female; 275 [20.9%] Black) with overweight or obesity (mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 33.9 [4.4]) were included at baseline. Six-month weight change achieved among those randomized to CR was -7.7% (95% CI, -8.3% to -7.2%), with no difference noted by sex; however, White individuals lost more weight than Black individuals assigned to CR (-9.0% [95% CI, -9.6% to -8.4%] vs -6.0% [95% CI, -6.9% to 5.2%]; P < .001), and all CR groups lost a significantly greater amount from baseline compared with non-CR groups (Black participants in CR vs non-CR groups, -5.3% [95% CI, -6.4% to -4.1%; P < .001]; White participants in CR vs non-CR groups, -7.2% [95% CI, -7.8% to -6.6%; P < .001]). Women experienced greater weight loss-associated improvement in SPPB score (CR group, 0.35 [95% CI, 0.18-0.52]; non-CR group, 0.08 [95% CI, -0.11 to 0.27]) compared with men (CR group, 0.23 [95% CI, 0.00-0.46]; non-CR group, 0.34 [95% CI, 0.09-0.58]; P = .03). Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s; non-CR group, 0.02 [95% CI, -0.01 to 0.05] m/s) compared with White participants (CR group, 0.07 [95% CI, 0.06-0.09] m/s; non-CR group, 0.06 [95% CI, 0.04-0.08] m/s; P = .02).
Conclusions and Relevance


The association of weight loss on physical function in older adults appears to differ by sex and race. These findings affirm the need to consider biological variables in clinical trial design.",2020,"Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s;","['older adults', 'weight loss conducted at Wake Forest University or Wake Forest School of Medicine, Winston-Salem, North Carolina', 'A total of 1317 adults (mean [SD] age, 67.7\u2009[5.4] years; 920', '69.9%] female; 275 [20.9%] Black) with overweight or obesity (mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 33.9\u2009[4.4]) were included at baseline', 'Data were collected from November 1996 to March 30, 2017, and analyzed from August 15, 2019, to June 10, 2020']",[],"['Main Outcomes and Measures\n\n\nObjectively measured 6-month change in weight, fast-paced gait speed (meters per second), and Short Physical Performance Battery (SPPB) score', 'SPPB score', 'weight loss', 'Physical Function', 'weight loss-associated improvement in gait speed']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",1317.0,0.165494,"Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s;","[{'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Jamy D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.14631']
1863,32821939,Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.,"Importance


Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown.
Objective


To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment.
Design, Setting, and Participants


Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020.
Interventions


Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d.
Main Outcomes and Measures


The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group.
Results


Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.
Conclusions and Relevance


Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.
Trial Registration


ClinicalTrials.gov Identifier: NCT04292730.",2020,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"['patients with moderate COVID-19', '94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia', '596 patients who were randomized', 'Patients With Moderate COVID-19', 'hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation', 'patients with severe coronavirus disease 2019 (COVID-19', ' 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial']","['Remdesivir vs Standard Care', 'remdesivir treatment', 'placebo']","['headache', 'Nausea', 'clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7', 'hypokalemia', 'clinical status distribution', 'Median length of treatment', 'clinical status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.105766,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"[{'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Arribas López', 'Affiliation': 'Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cattelan', 'Affiliation': 'Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Soriano Viladomiu', 'Affiliation': 'Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Onyema', 'Initials': 'O', 'LastName': 'Ogbuagu', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': 'North Shore University Hospital, Manhasset, New York.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Louis Yi Ann', 'Initials': 'LYA', 'LastName': 'Chai', 'Affiliation': 'National University Health System, Singapore.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Owen Tak Yin', 'Initials': 'OTY', 'LastName': 'Tsang', 'Affiliation': 'Princess Margaret Hospital, Hong Kong, China.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Le Turnier', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'Shan-Chwen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anu O', 'Initials': 'AO', 'LastName': 'Osinusi', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'McPhail', 'Affiliation': ""King's College, London, England.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Bhagani', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Ahn', 'Affiliation': 'Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.16349']
1864,32822131,Editorial Comment: Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,,2020,,[],"['Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia', 'Editorial Comment']",[],[],"[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.018115,,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Denstedt', 'Affiliation': 'Division of Urology, Western University, Ontario, Canada.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770.1']
1865,32822130,Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,"PURPOSE


To compare the effect of general anesthesia (GA) and regional anesthesia (RA) on f-URS outcomes and surgeon comfort.
MATERIAL AND METHODS


The study was conducted between June 2017 to January 2018 and data collection was applied in a prospective, randomized fashion. 120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64). Demographic, operative and post-operative parameters of patients were analysed. The end point of this study was the effect of two anesthesia regimens on the comfort of the surgeon, and the comparability of feasibility and safety against perioperative complications.
RESULTS


The study including 120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group). No difference was detected between the two groups in terms of preoperative data. During the monitorization of operative vital signs, 3 patients in RA group experienced bradycardia, and this finding was significant when compared with GA group (p=0.041). Additionally, 2 patients in RA group experienced mucosal tears and 1 patient experienced hemorrhage during the operation, but no complications were observed in the GA group (p=0.041). Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
CONCLUSIONS


Both GA and RA are equally effective and safe anesthesia methods for f-URS procedures. However, RA group showed significantly increased likelihood of bradycardia and mucosal injury during surgery, and significantly decreased surgeon comfort during surgery.",2020,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","['June 2017 to January 2018 and data collection', '120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group', '120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64']","['general anesthesia (GA) and regional anesthesia (RA', 'Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia']","['bradycardia', 'likelihood of bradycardia and mucosal injury', 'surgeon comfort', 'mucosal tears and 1 patient experienced hemorrhage']","[{'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",120.0,0.0376006,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sahan', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Sarilar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Fatih', 'Initials': 'MF', 'LastName': 'Akbulut', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Demir', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Savun', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Oznur', 'Initials': 'O', 'LastName': 'Sen', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Ozgor', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770']
1866,32822141,"Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial.",,2020,,['prostate cancer'],['Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.109669,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.06.09']
1867,32817068,Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials.,"BACKGROUND


Symptoms of advanced hepatocellular carcinoma (HCC) represent a substantial burden for the patient and are important endpoints to assess when evaluating treatment. Patient-reported outcomes were evaluated in subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400 ng/mL treated with second-line ramucirumab.
PATIENTS AND METHODS


Patients with AFP≥400 ng/mL enrolled in the REACH or REACH-2 phase 3 studies were used in this analysis. Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib. Patients received ramucirumab 8 mg/kg or placebo once every 2 weeks. Disease-related symptoms and health-related quality of life (HRQoL) were assessed with the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D) instruments, respectively. Time to deterioration (TTD) (≥3-point decrease in FHSI-8 total score;≥0.06-point decrease in EQ-5D score, from randomisation to first date of deterioration) was determined using Kaplan-Meier estimation and the Cox proportional hazards model. Both separate and pooled analyses for REACH AFP≥400 ng/mL and REACH-2 patients were conducted.
RESULTS


In the pooled population with AFP ≥400 ng/mL (n=542; ramucirumab, n=316; placebo, n=226), median TTD in FHSI-8 total score was prolonged with ramucirumab relative to placebo (3.3 vs 1.9 months; HR 0.725; (95% CI 0.559 to 0.941); p=0.0152), including significant differences in back pain (0.668; (0.497 to 0.899); p=0.0044), weight loss (0.699; (0.505 to 0.969); p=0.0231) and pain (0.769; (0.588 to 1.005); p=0.0248) symptoms. TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months). Results in the individual trials were consistent with these findings.
CONCLUSIONS


Ramucirumab in second-line treatment of advanced HCC demonstrates consistent benefit in the delay of deterioration in disease-related symptoms with no worsening of HRQoL. Taken with previously demonstrated ramucirumab-driven survival benefits in this setting, these data may inform patient-clinician discussions about the benefit-risk profile of this therapy.
TRIAL REGISTRATION NUMBER


NCT01140347; NCT02435433, NCT02435433.",2020,TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months).,"['patients with hepatocellular carcinoma and elevated alpha-fetoprotein', 'subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400', 'Patients with AFP≥400\u2009ng/mL enrolled in the REACH or REACH-2 phase 3 studies', 'Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib', 'advanced hepatocellular carcinoma (HCC']","['ramucirumab 8\u2009mg/kg or placebo', 'Ramucirumab', 'placebo']","['TTD in EQ-5D score', 'Time to deterioration (TTD', 'Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D', 'median TTD in FHSI-8 total score', 'back pain', 'weight loss', 'Disease-related symptoms and health-related quality of life (HRQoL', 'pain', 'EQ-5D score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0235971', 'cui_str': 'Alpha 1 foetoprotein increased'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.551931,TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months).,"[{'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA azhu@mgh.harvard.edu.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, Geffen School of Medicine, University of California-Los Angeles Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'First Department of Internal Medicine, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': ""Translational Research Lab in Hepatic Oncology, Liver Unit, Institut d'Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Department of Hepatogastroenterology and Medical Oncology, CHU de Bordeaux Hôpital Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'Allicia', 'Initials': 'A', 'LastName': 'Girvan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Gable', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bowman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'TG Therapeutics, New York City, New York, USA.'}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Gastroenterology and Hepatology, Kindai University, Osaka, Japan.'}]",ESMO open,['10.1136/esmoopen-2020-000797']
1868,32817130,Gemcitabine/nab-paclitaxel with pamrevlumab: a novel drug combination and trial design for the treatment of locally advanced pancreatic cancer.,"PURPOSE


Pancreatic ductal adenocarcinomas exhibit a high degree of desmoplasia due to extensive extracellular matrix deposition. Encasement of mesenteric vessels by stroma in locally advanced pancreatic cancer (LAPC) prevents surgical resection. This study sought to determine if the addition of a monoclonal antibody to connective tissue growth factor, pamrevlumab, to neoadjuvant chemotherapy would be safe and lead to improved resectability in this surgically adverse patient population.
METHODS


In this phase I/II trial, 37 patients with LAPC were randomised 2:1 to gemcitabine/nab-paclitaxel plus (Arm A, n=24) or minus (Arm B, n=13) pamrevlumab. Those who completed six cycles of treatment were assessed for surgical eligibility by protocol-defined criteria. Resection rates, progression-free and overall survival were evaluated.
RESULTS


Eighteen (75%) patients in Arm A and seven (54%) in Arm B completed six cycles of therapy with similar toxicity patterns. In Arms A and B, carbohydrate antigen 19-9 response, as defined by ≥50% decline from baseline, occurred in 13 (65%) and 5 (42%), respectively. Sixteen (16%) per cent of patients were radiographically downstaged by National Comprehensive Cancer Network criteria (5 in Arm A (21%) and 1 (8%) in Arm B). Positron emission tomography normalised in 9 (38%) vs 3 (23%) of patients in Arm A vs Arm B, respectively, and correlated with surgical exploration. Eligibility for surgical exploration was 17 (71%) vs 2 (15%) (p=0.0019) and resection was achieved in 8 (33%) vs 1 (8%) of patients in Arm A vs Arm B (p=0.1193), respectively. Postoperative complication rates were not different between arms.
CONCLUSIONS


Neoadjuvant chemotherapy with pamrevlumab holds promise for enhancing resection rates in patients with LAPC without added toxicity. This combination merits evaluation in a larger patient cohort.",2020,"Eligibility for surgical exploration was 17 (71%) vs 2 (15%) (p=0.0019) and resection was achieved in 8 (33%) vs 1 (8%) of patients in Arm A vs Arm B (p=0.1193), respectively.","['37 patients with LAPC', 'patients with LAPC without added toxicity', 'surgically adverse patient population', 'locally advanced pancreatic cancer (LAPC', 'locally advanced pancreatic cancer']","['Gemcitabine/nab-paclitaxel with pamrevlumab', 'gemcitabine/nab-paclitaxel plus']","['Eligibility for surgical exploration', 'Positron emission tomography normalised', 'enhancing resection rates', 'Resection rates, progression-free and overall survival', 'Postoperative complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0184899', 'cui_str': 'Exploratory incision'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",37.0,0.0920044,"Eligibility for surgical exploration was 17 (71%) vs 2 (15%) (p=0.0019) and resection was achieved in 8 (33%) vs 1 (8%) of patients in Arm A vs Arm B (p=0.1193), respectively.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA vincent.picozzi@vmmc.org.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Alseidi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Thomas Jefferson Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pishvaian', 'Affiliation': 'Georgetown Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kabir', 'Initials': 'K', 'LastName': 'Mody', 'Affiliation': 'Mayo Clinic Jacksonville, Jacksonville, Florida, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'UCLA Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Larson', 'Affiliation': 'Virginia Piper Cancer Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Matrana', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, Louisiana, USA.'}, {'ForeName': 'Mairead', 'Initials': 'M', 'LastName': 'Carney', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kouchakji', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Rocha', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Carrier', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}]",ESMO open,['10.1136/esmoopen-2019-000668']
1869,32817131,Effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors at baseline: an exploratory analysis.,"BACKGROUND


The choice of treatment in patients with metastatic colorectal cancer (mCRC) is generally influenced by tumour and patient characteristics, treatment efficacy and tolerability, and quality of life. Better patient selection might lead to improved outcomes.
METHODS


This post hoc exploratory analysis examined the effect of prognostic factors on outcomes in the Randomized, Double-blind, Phase 3 Study of trifluridine tipiracil (FTD/TPI) plus Best Supportive Care (BSC) versus Placebo plus BSC in Patients with mCRC Refractory to Standard Chemotherapies (RECOURSE) trial. Patients were redivided by prognosis into two subgroups: those with <3 metastatic sites at randomisation (low tumour burden) and ≥18 months from diagnosis of metastatic disease to randomisation (indolent disease) were included in the good prognostic characteristics (GPC) subgroup; the remaining patients were considered to have poor prognostic characteristics (PPC).
RESULTS


GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms. GPC patients receiving trifluridine/tipiracil (n=261) had an improved median overall survival (9.3 vs 5.3 months; HR (95% CI) 0.46 (0.37 to 0.57), p<0.0001) and progression-free survival (3.3 vs 1.9 months; HR (95% CI) 0.56 (0.46 to 0.67), p<0.0001) than PPC patients receiving trifluridine/tipiracil (n=273). Improvements in survival were irrespective of age, Eastern Cooperative Oncology Group Performance Status (ECOG PS),  KRAS  mutational status, and site of metastases at randomisation. In the trifluridine/tipiracil arm, time to deterioration of ECOG PS to ≥2 and proportion of patients with PS=0-1 discontinuing treatment were longer for GPC than for PPC patients (7.8 vs 4.2 months and 89.1% vs 78.4%, respectively).
CONCLUSION


Low tumour burden and indolent disease were factors of good prognosis in late-line mCRC, with patients experiencing longer progression-free survival and greater overall survival.",2020,"RESULTS


GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms.","['Patients with mCRC Refractory to Standard Chemotherapies (RECOURSE) trial', 'GPC patients receiving', 'patients with metastatic colorectal cancer (mCRC', 'Patients were redivided by prognosis into two subgroups: those with <3 metastatic sites at randomisation (low tumour burden) and ≥18 months from diagnosis of metastatic disease to randomisation (indolent disease) were included in the good prognostic characteristics (GPC) subgroup; the remaining patients were considered to have poor prognostic characteristics (PPC']","['trifluridine/tipiracil', 'trifluridine tipiracil (FTD/TPI) plus Best Supportive Care (BSC) versus Placebo plus BSC']","['Performance Status (ECOG PS),  KRAS  mutational status, and site of metastases', 'progression-free survival', 'overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.322874,"RESULTS


GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms.","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron Institute of Oncology, UVic-UCC, Medical Oncology, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain jtabernero@vhio.net.""}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Argiles', 'Affiliation': ""Vall d'Hebron Institute of Oncology, UVic-UCC, IOB-QuironMedical Oncology, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain.""}, {'ForeName': 'Alberto F', 'Initials': 'AF', 'LastName': 'Sobrero', 'Affiliation': ""Medical Oncology, Ospedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l'Oncologia, Genova, Liguria, Italy.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Medical Oncology, University Hospital Centre Besançon, Besancon, Bourgogne Franche-Comté, France.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'Kashiwa, National Cancer Center-Hospital East, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Loick', 'Initials': 'L', 'LastName': 'Vidot', 'Affiliation': 'Centre of EXcellence Methodology and Valorization of Data (CentEX MVD), Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Shanti R', 'Initials': 'SR', 'LastName': 'Moreno Vera', 'Affiliation': 'Global Medical Affairs, Les Laboratoires Servier SAS, Suresnes, Île-de-France, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, KU Leuven University Hospitals Leuven, Leuven, Flanders, Belgium.'}]",ESMO open,['10.1136/esmoopen-2020-000752']
1870,32817632,Evaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial.,"BACKGROUND


The World Health Organization has yet to endorse deployment of topical repellents for malaria prevention as part of public health campaigns. We aimed to quantify the effectiveness of repellent distributed by the village health volunteer (VHV) network in the Greater Mekong Subregion (GMS) in reducing malaria in order to advance regional malaria elimination.
METHODS AND FINDINGS


Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks) to test the effectiveness of 12% N,N-diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp. infection. The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40%). No adverse events were reported during the study. Generalised linear mixed modelling estimated the effect of repellent on infection detected by rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR) (secondary outcome). Overall Plasmodium infection detected by RDT was low (0.16%; 50/32,194), but infection detected by PCR was higher (3%; 419/13,157). There was no significant protection against RDT-detectable infection (adjusted odds ratio [AOR] = 0.25, 95% CI 0.004-15.2, p = 0.512). In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233). Repellent effects were similar when delayed effects were modelled, across risk groups, and regardless of village-level and temporal heterogeneity in malaria prevalence. The incremental cost-effectiveness ratio was US$256 per PCR-detectable infection averted. Study limitations were a lower than expected Plasmodium spp. infection rate and potential geographic dilution of the intervention.
CONCLUSIONS


In this study, we observed apparent protection against new infections associated with the large-scale distribution of repellent by VHVs. Incorporation of repellent into national strategies, particularly in areas where bed nets are less effective, may contribute to the interruption of malaria transmission. Further studies are warranted across different transmission settings and populations, from the GMS and beyond, to inform WHO public health policy on the deployment of topical repellents for malaria prevention.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry (ACTRN12616001434482).",2020,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","['infection in Myanmar', 'Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks', 'village health volunteer networks against\xa0Plasmodium spp', 'The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40']","['diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp', 'village health volunteer (VHV) network in the Greater Mekong Subregion (GMS']","['infection rate and potential geographic dilution', 'protection against RDT-detectable infection', 'rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR', 'incremental cost-effectiveness ratio', 'adverse events', 'Overall Plasmodium infection']","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086312', 'cui_str': 'Forest'}]","[{'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",,0.250486,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Agius', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Cutts', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Han Oo', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Thi', 'Affiliation': 'Department of Public Health, Myanmar Ministry of Health and Sports, Nay Pyi Taw, Myanmar.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': ""O'Flaherty"", 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Kyaw', 'Initials': 'K', 'LastName': 'Zayar Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Htin', 'Initials': 'H', 'LastName': 'Kyaw Thu', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Poe', 'Initials': 'P', 'LastName': 'Poe Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Myat', 'Initials': 'M', 'LastName': 'Mon Thein', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Nyi', 'Initials': 'N', 'LastName': 'Nyi Zaw', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Yan Min Htay', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Paing Soe', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Razook', 'Affiliation': 'Population Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alyssa E', 'Initials': 'AE', 'LastName': 'Barry', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Htike', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendan S', 'Initials': 'BS', 'LastName': 'Crabb', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Naanki', 'Initials': 'N', 'LastName': 'Pasricha', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Freya J I', 'Initials': 'FJI', 'LastName': 'Fowkes', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}]",PLoS medicine,['10.1371/journal.pmed.1003177']
1871,32817638,Correction: A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults.,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,['well-trained middle and older-aged adults'],['nitrate supplementation'],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],,0.0815607,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': ''}, {'ForeName': 'Macie S', 'Initials': 'MS', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'Caleb G', 'Initials': 'CG', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Gauthier', 'Affiliation': ''}, {'ForeName': 'Summer L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': ''}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Heinrich', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238271']
1872,32816829,Adherence to early pulmonary rehabilitation after COPD exacerbation and risk of hospital readmission: a secondary analysis of the COPD-EXA-REHAB study.,"BACKGROUND


Early pulmonary rehabilitation after exacerbation of chronic obstructive pulmonary disease (COPD) has previously been shown to reduce the risk of hospital admission and improve physical performance and quality of life. However, the impact of attendance at early rehabilitation programmes has not been established.
OBJECTIVES


To evaluate the impact of increasing attendance to pulmonary rehabilitation on the risk of hospital admission, physical performance and quality of life in patients attending an early rehabilitation programme after an exacerbation of COPD.
METHODS


This study was a secondary exploratory analysis of the randomised controlled trial COPD-EXA-REHAB study, involving patients hospitalised with an exacerbation of COPD. The COPD-EXA-REHAB study compared early pulmonary rehabilitation, starting within 2 weeks after an exacerbation, with standard treatment, that is, the same programme starting 2 months later. The present analysis included only the 70 patients allocated to early pulmonary rehabilitation.
RESULTS


At 1-year follow-up, we found an association between the number of sessions attended and a reduction in hospital admissions (incidence rate ratio 0.93 (95% CI 0.88 to 0.99), p=0.02), corresponding to a 7% reduction for each session attended. Similarly, at 2-month follow-up, physical performance was positively associated with sessions attended: the mean Incremental Shuttle Walk Test result improved by 8 m with each session (95% CI 2.54 to 13.56, p=0.005) and the Endurance Shuttle Walk Test result by 44 s (95% CI 18.41 to 68.95, p=0.001). Quality of life, assessed using the COPD Assessment Test, was not significantly associated with the number of attended sessions, with the average score increasing by 0.15 points with each session (95% CI -0.35 to 0.65, p=0.55).
CONCLUSION


Increased attendance at early pulmonary rehabilitation after exacerbation of COPD was associated with reduced risk of hospital admission and improved physical performance.",2020,"the Endurance Shuttle Walk Test result by 44 s (95% CI 18.41 to 68.95, p=0.001).","['patients attending an early rehabilitation programme after an exacerbation of COPD', '70 patients allocated to early pulmonary rehabilitation', 'chronic obstructive pulmonary disease (COPD', 'patients hospitalised with an exacerbation of COPD']",[],"['risk of hospital admission and improved physical performance', 'risk of hospital admission, physical performance and quality of life', 'COPD exacerbation and risk of hospital readmission', 'mean Incremental Shuttle Walk Test result', 'Quality of life', 'physical performance', 'hospital admissions', 'physical performance and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.177559,"the Endurance Shuttle Walk Test result by 44 s (95% CI 18.41 to 68.95, p=0.001).","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Internal Medicine, Respiratory Section, Herlev and Gentofte Hospital, Copenhagen University, Hellerup, Denmark jakob@naj.dk.'}, {'ForeName': 'Carsten Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospitals, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Section of Epidemiology, Institute of Public Health, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Department of Internal Medicine, Respiratory Section, Herlev and Gentofte Hospital, Copenhagen University, Hellerup, Denmark.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000582']
1873,32816830,"Does Fibre-fix provided to people with irritable bowel syndrome who are consuming a low FODMAP diet improve their gut health, gut microbiome, sleep and mental health? A double-blinded, randomised controlled trial.","INTRODUCTION


A diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) is an effective way to reduce gut symptoms in people with irritable bowel syndrome (IBS). This diet reduces the intake of fermentable fibres, leading to changes of the gut microbiota and insufficient fermentation in the large bowel, resulting in reduced production of short-chain fatty acids (SCFAs), such as butyrate, which has unfavourable implications for gut health, sleep and mental health. This study will examine the effect of Fibre-fix, a supplement containing a mix of dietary fibres, on the human gut microbiome composition, fermentative capacity, sleep, quality of life (QOL) and mental health of people with IBS who consume a low FODMAP diet (LFD).
METHODS AND ANALYSIS


A randomised, double-blind, placebo-controlled, study design is proposed to examine whether Fibre-fix added to an existing LFD may help modulate gastrointestinal function, improve markers of sleep, mental health and promote QOL in patients with IBS. Participants will provide stool and blood samples, daily bowel symptoms diaries and 3-day diet records. Additionally, they will complete validated questionnaires relating to FODMAP intake, sleep, mental health and QOL before and after a 3-week intervention. Gut health will be assessed via faecal microbiome composition, faecal pH and SCFA levels. Alteration of sleep will be recorded using an actigraphy device worn by all participants over the whole study. Multivariate analysis will be used to examine the gut microbiome and repeated measures Analysis of variance (ANOVA) will be used for dependent variables from questionnaires related to bowel symptoms, stool type, sleep, mental health and QOL to assess the differences between intervention and control groups after adjustment for confounding variables.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Human Research Ethics Committee of Edith Cowan University (2019-00619-YAN). Results will be disseminated in peer-review journal publications, and conference presentations. Participants will be provided with a summary of findings once the study is completed. If Fibre-fix is shown to result in favourable changes in gut microbial composition, SCFA production, sleep and mental well-being without exacerbating symptoms, this will provide additional dietary management options for those with IBS following an LFD.
TRIAL REGISTRATION NUMBER


ACTRN12620000032954.",2020,"If Fibre-fix is shown to result in favourable changes in gut microbial composition, SCFA production, sleep and mental well-being without exacerbating symptoms, this will provide additional dietary management options for those with IBS following an LFD.
","['people with irritable bowel syndrome', 'people with irritable bowel syndrome (IBS', 'people with IBS who consume a low FODMAP diet (LFD', 'patients with IBS']",['placebo'],"['FODMAP intake, sleep, mental health and QOL', 'bowel symptoms, stool type, sleep, mental health and QOL', 'faecal microbiome composition, faecal pH and SCFA levels', 'human gut microbiome composition, fermentative capacity, sleep, quality of life (QOL) and mental health']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2711455', 'cui_str': 'Fecal pH'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.320202,"If Fibre-fix is shown to result in favourable changes in gut microbial composition, SCFA production, sleep and mental well-being without exacerbating symptoms, this will provide additional dietary management options for those with IBS following an LFD.
","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia r.yan@ecu.edu.au.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genoni', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Evania', 'Initials': 'E', 'LastName': 'Marlow', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Dunican', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Andrew', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Claus T', 'Initials': 'CT', 'LastName': 'Christophersen', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000448']
1874,32816872,Exercise training improves adipose tissue metabolism and vasculature regardless of baseline glucose tolerance and sex.,"INTRODUCTION


We investigated the effects of a supervised progressive sprint interval training (SIT) and moderate-intensity continuous training (MICT) on adipocyte morphology and adipose tissue metabolism and function; we also tested whether the responses were similar regardless of baseline glucose tolerance and sex.
RESEARCH DESIGN AND METHODS


26 insulin-resistant (IR) and 28 healthy participants were randomized into 2-week-long SIT (4-6×30 s at maximum effort) and MICT (40-60 min at 60% of maximal aerobic capacity (VO 2peak )). Insulin-stimulated glucose uptake and fasting-free fatty acid uptake in visceral adipose tissue (VAT), abdominal and femoral subcutaneous adipose tissues (SATs) were quantified with positron emission tomography. Abdominal SAT biopsies were collected to determine adipocyte morphology, gene expression markers of lipolysis, glucose and lipid metabolism and inflammation.
RESULTS


Training increased glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake in VAT (p=0.01) irrespective of baseline glucose tolerance and sex. In IR participants, training increased adipose tissue vasculature and decreased CD36 and ANGPTL4 gene expression in abdominal SAT. SIT was superior in increasing VO 2peak  and VAT glucose uptake in the IR group, whereas MICT reduced VAT fatty acid uptake more than SIT.
CONCLUSIONS


Short-term training improves adipose tissue metabolism both in healthy and IR participants independently of the sex. Adipose tissue angiogenesis and gene expression was only significantly affected in IR participants.",2020,"RESULTS


Training increased glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake in VAT (p=0.01) irrespective of baseline glucose tolerance and sex.",['26 insulin-resistant (IR) and 28 healthy participants'],"['MICT', 'supervised progressive sprint interval training (SIT) and moderate-intensity continuous training (MICT', 'Exercise training', 'Short-term training']","['adipose tissue metabolism and vasculature regardless of baseline glucose tolerance and sex', 'adipocyte morphology and adipose tissue metabolism and function', 'adipose tissue metabolism', 'glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake', 'Adipose tissue angiogenesis and gene expression', 'Insulin-stimulated glucose uptake and fasting-free fatty acid uptake in visceral adipose tissue (VAT), abdominal and femoral subcutaneous adipose tissues (SATs', 'VO 2peak  and VAT glucose uptake', 'adipocyte morphology, gene expression markers of lipolysis, glucose and lipid metabolism and inflammation', 'adipose tissue vasculature and decreased CD36']","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0054954', 'cui_str': 'Lymphocyte antigen CD36'}]",,0.0307792,"RESULTS


Training increased glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake in VAT (p=0.01) irrespective of baseline glucose tolerance and sex.","[{'ForeName': 'Sanna Maria', 'Initials': 'SM', 'LastName': 'Honkala', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Piryanka', 'Initials': 'P', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Kivelä', 'Affiliation': 'Stem Cells and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Karthik Amudhala', 'Initials': 'KA', 'LastName': 'Hemanthakumar', 'Affiliation': 'Stem Cells and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Tolvanen', 'Affiliation': 'Stem Cells and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kumail Kumar', 'Initials': 'KK', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jari-Joonas', 'Initials': 'JJ', 'LastName': 'Eskelinen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi A', 'Initials': 'KA', 'LastName': 'Virtanen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Kemppainen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Marja Anneli', 'Initials': 'MA', 'LastName': 'Heiskanen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nuutila', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Kalliokoski', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jarna Christina', 'Initials': 'JC', 'LastName': 'Hannukainen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland jarna.hannukainen@tyks.fi.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000830']
1875,32825070,Incentivizing Commuter Cycling by Financial and Non-Financial Rewards.,"Current mobility patterns over-rely on transport modes that do not benefit sustainable and healthy lifestyles. To explore the potential for active mobility, we conducted a randomized experiment aimed at increasing regular commuter cycling in cities. In designing the experiment, we teamed up with developers of the ""Cyclers"" smartphone app to improve the effectiveness of the app by evaluating financial and non-financial motivational features. Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation). Our analysis suggests that people can be effectively motivated to engage in more frequent commuter cycling with incentives via a smartphone app. Offering small financial rewards seems to be more effective than smart gamification. A combination of both motivational treatments-smart gamification and financial rewards-may work the same or slightly better than financial rewards alone. We demonstrate that small financial rewards embedded in smartphone apps such as ""Cyclers"" can be effective in nudging people to commute by bike more often.",2020,"Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation).","['Participants in the experiment were recruited among new users of the app', 'cities']","['motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation']",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",[],,0.0338274,"Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation).","[{'ForeName': 'Vojtěch', 'Initials': 'V', 'LastName': 'Máca', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Ščasný', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Zvěřinová', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Jakob', 'Affiliation': 'FEE, Artificial Intelligence Center, Czech Technical University in Prague, 121 35 Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hrnčíř', 'Affiliation': 'Umotional s.r.o., 120 00 Prague, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17176033']
1876,32825282,Impact of Nurses' Intervention in the Prevention of Falls in Hospitalized Patients.,"BACKGROUND


Clinical safety is a crucial component of healthcare quality, focused on identifying and avoiding the risks to which patients are exposed. Among the adverse events that occur in a hospital environment, falls have a large impact (1.9-10% of annual income in acute care hospitals); they can cause pain, damage, costs, and mistrust in the health system. Our objective was to assess the effect of an educational intervention aimed at hospital nurses (systematic assessment of the risk of falls) in reducing the incidence of falls.
METHODS


this was a quasi-experimental study based on a sample of 581 patients in a third level hospital (Comunitat Valenciana, Spain). An educational program was given to the intervention group ( n  = 303), and a control group was included for comparison ( n  = 278). In the intervention group, the nurses participated in a training activity on the systematized assessment of the risk of falls. Analysis was undertaken using the Bayesian logistic regression model.
RESULTS


a total of 581 patients were studied (50.6% male, 49.4% female), with an average age of 68.3 (DT = 9) years. The overall incidence of falls was 1.2% (0.3% in the intervention group and 2.2% in the control group). Most of the falls occurred in people ≥65 years old (85.7%). The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821). Neither the length of hospital stay, nor the age of the participants, had any relevant effect.
CONCLUSIONS


the systematic assessment of the risk of a patient falling during hospital processes is an effective intervention to reduce the incidence of falls.",2020,The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821).,"['Hospitalized Patients', 'a total of 581 patients were studied (50.6% male, 49.4% female), with an average age of 68.3 (DT = 9) years', '581 patients in a third level hospital (Comunitat Valenciana, Spain']","['educational intervention', ""Nurses' Intervention""]","['lower probability of falling', 'length of hospital stay', 'overall incidence of falls']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",581.0,0.0392586,The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821).,"[{'ForeName': 'Raimunda', 'Initials': 'R', 'LastName': 'Montejano-Lozoya', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Miguel-Montoya', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Gea-Caballero', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Mármol-López', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ruíz-Hontangas', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Ortí-Lucas', 'Affiliation': 'Public Health Department, Catholic University of Valencia, 46001 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176048']
1877,32825324,High-Dose Vitamin D Supplementation Improves Microcirculation and Reduces Inflammation in Diabetic Neuropathy Patients.,"We assessed the effect of different doses of vitamin D supplementation on microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers in patients with type 2 diabetes (T2DM). Sixty-seven patients with T2DM and peripheral neuropathy (34 females) were randomized into two treatment groups: Cholecalciferol 5000 IU and 40,000 IU once/week orally for 24 weeks. Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment. Vitamin D deficiency/insufficiency was detected in 78% of the 62 completed subjects. Following treatment with cholecalciferol 40,000 IU/week, a significant decrease in neuropathy severity (NSS,  p  = 0.001; NDS,  p  = 0.001; VAS,  p  = 0.001) and improvement of cutaneous MC were observed ( p  < 0.05). Also, we found a decrease in IL-6 level (2.5 pg/mL vs. 0.6 pg/mL,  p  < 0.001) and an increase in IL-10 level (2.5 pg/mL vs. 4.5 pg/mL,  p  < 0.001) after 24 weeks of vitamin D supplementation in this group. No changes were detected in the cholecalciferol 5000 IU/week group. High-dose cholecalciferol supplementation of 40,000 IU/week for 24 weeks was associated with improvement in clinical manifestation, cutaneous microcirculation and inflammatory markers in patients with T2DM and peripheral neuropathy.",2020,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","['78% of the 62 completed subjects', 'Diabetic Neuropathy Patients', 'Sixty-seven patients with T2DM and peripheral neuropathy (34 females', 'patients with type 2 diabetes (T2DM', 'patients with T2DM and peripheral neuropathy']","['High-Dose Vitamin D Supplementation', 'Cholecalciferol 5000 IU', 'vitamin D supplementation', 'cholecalciferol']","['microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers', 'Vitamin D deficiency/insufficiency', 'clinical manifestation, cutaneous microcirculation and inflammatory markers', 'neuropathy severity', 'Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα', 'improvement of cutaneous MC', 'IL-10 level', 'IL-6 level']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4319610', 'cui_str': '5000'}]","[{'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",67.0,0.160226,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Karonova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stepanova', 'Affiliation': 'Internal Medicine Department, Pavlov First Saint Petersburg State Medical University, 6-8 L.Tolstoy str., 197022 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bystrova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Jude', 'Affiliation': 'Tameside Hospital NHS Foundation Trust, Ashton Under Lyne OL69RW, UK.'}]",Nutrients,['10.3390/nu12092518']
1878,32825337,Enhancing Cognitive Performance of Healthy Czech Seniors through Non-Native Language Learning-A Mixed-Methods Pilot Study.,"The aim of this article is to discuss the effect of learning a non-native language on the enhancement of cognitive performance in healthy native Czech elderly. In addition, special emphasis is put on the qualitative assessment. To do this, 42 Czech cognitively unimpaired seniors were enrolled into the study. These were then divided into an experimental group (i.e., 20 healthy elderly studied English as a non-native language for three months) and a passive control group (22 healthy elderly, who did not undergo any non-native language intervention). The main outcome measures included the Montreal Cognitive Assessment, statistical processing of the data, and a qualitative content analysis. The results indicate that the cognitive performance of the intervention group did not differ from the control group. Therefore, no cognitive enhancement through non-native language learning was achieved. However, the findings of the qualitative analysis show that such non-native language learning with the peers of the same age is especially beneficial for the overall well-being of healthy seniors, especially as far as their social networks are concerned. Furthermore, participant's subjective feelings from their self-reports indicate that foreign language learning also contributes to acquiring new English words and phrases. However, as there are very few empirical studies on this research topic, further research is needed in order to confirm or refute the present research findings on the enhancement of cognitive performance through non-native language learning in healthy seniors.",2020,The results indicate that the cognitive performance of the intervention group did not differ from the control group.,"['42 Czech cognitively unimpaired seniors were enrolled into the study', '20 healthy elderly studied English as a non-native language for three months) and a passive control group (22 healthy elderly, who did not undergo any non-native language intervention', 'Healthy Czech Seniors', 'healthy native Czech elderly', 'healthy seniors']",['learning a non-native language'],"['cognitive performance', 'Montreal Cognitive Assessment, statistical processing of the data, and a qualitative content analysis']","[{'cui': 'C0010871', 'cui_str': 'Czech language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",20.0,0.0153599,The results indicate that the cognitive performance of the intervention group did not differ from the control group.,"[{'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Klimova', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Slaninova', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Prazak', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Kacetl', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Valis', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}]",Brain sciences,['10.3390/brainsci10090573']
1879,32825378,Effects of Six Weeks of High-Intensity Functional Training on Physical Performance in Participants with Different Training Volumes and Frequencies.,"High-intensity functional training (HIFT) is characterized by presenting high volumes and training intensities with constantly varied exercises. The aim of this study was to analyze the internal training load and the effects of high-intensity functional training on physical performance in subjects with different training volumes and frequencies. A total of 31 volunteers involved in high-intensity functional training (14 men and 17 women) were divided according to their training volumes and frequencies (high training-volume and frequency-HTVF; ( n  = 17) (nine women and eight men; age: 31.0 ± 6.3 years; height: 168.8 ± 8.1 cm, body weight: 73.6 ± 11.9 kg; BMI: 25.96 kg/m 2 ) and moderate training volume and frequency-MTVF; ( n  = 14) (eight women and six men; age: 26.6 ± 4.7 years; height: 167.2 ± 8.6 cm, body weight: 75.8 ± 18.0 kg; BMI: 27.33 kg/m 2 )). The internal training load was determined using the session-rating of perceived exertion method. The monotony index (MI) and training strain (TS) were used to determine training variability during the training weeks. Countermovement vertical jump height, 20-m sprinting and handgrip strength were assessed at baseline and after six weeks of training. There was a time effect for MI ((F (5, 145)  = 5.942;  p  = 0.0001)), TS ((F (5, 145)  = 5.734;  p  = 0.0001)), weekly internal training load ((F (4.006, 116.87)  = 4.188;  p  = 0.003)) and mean weekly internal training load ((F (4.006, 116.87)  = 4.188;  p  = 0.003)). There was no increase in performance in either group for countermovement vertical jump height ((F (1,29)  = 6.081;  p  = 0.050)), sprinting ((F (1,29)  = 1.014;  p  = 0.322)), right handgrip strength ((F (1,29)  = 2.522;  p  = 0.123)) or left handgrip strength ((F (1,29)  = 2.550;  p  = 0.121)). The current findings suggest that six weeks of high-intensity functional training was not able to increase performance in either group. Therefore, different volumes and frequencies do not seem to influence the increase in physical performance of HIFT practitioners.",2020,"There was no increase in performance in either group for countermovement vertical jump height ((F (1,29)  = 6.081;  p  = 0.050)), sprinting ((F (1,29)  = 1.014;  p  = 0.322)), right handgrip strength ((F (1,29)  = 2.522;  p  = 0.123)) or left handgrip strength ((F (1,29)  = 2.550;  p  = 0.121)).","['Participants with Different Training Volumes and Frequencies', ' n  = 17) (nine women and eight men; age: 31.0 ± 6.3 years; height: 168.8 ± 8.1 cm, body weight: 73.6 ± 11.9 kg; BMI: 25.96 kg/m 2 ) and moderate training volume and frequency-MTVF; ( n  = 14) (eight women and six men; age: 26.6 ± 4.7 years; height: 167.2 ± 8.6 cm, body weight: 75.8 ± 18.0 kg; BMI: 27.33 kg/m 2 ', 'subjects with different training volumes and frequencies', '31 volunteers involved in high-intensity functional training (14 men and 17 women']","['training volumes and frequencies (high training-volume and frequency-HTVF', 'High-Intensity Functional Training', 'high-intensity functional training', 'High-intensity functional training (HIFT']","['weekly internal training load', 'performance', 'countermovement vertical jump height', 'right handgrip strength', 'monotony index (MI) and training strain (TS', 'mean weekly internal training load', 'Countermovement vertical jump height, 20-m sprinting and handgrip strength', 'physical performance', 'left handgrip strength', 'Physical Performance']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205091', 'cui_str': 'Left'}]",31.0,0.0237396,"There was no increase in performance in either group for countermovement vertical jump height ((F (1,29)  = 6.081;  p  = 0.050)), sprinting ((F (1,29)  = 1.014;  p  = 0.322)), right handgrip strength ((F (1,29)  = 2.522;  p  = 0.123)) or left handgrip strength ((F (1,29)  = 2.550;  p  = 0.121)).","[{'ForeName': 'Rômulo Vasconcelos', 'Initials': 'RV', 'LastName': 'Teixeira', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Gilmário Ricarte', 'Initials': 'GR', 'LastName': 'Batista', 'Affiliation': 'Department of Physical Education, Federal University of Paraíba, João Pessoa, Paraíba 58051900, Brazil.'}, {'ForeName': 'Arnaldo Luis', 'Initials': 'AL', 'LastName': 'Mortatti', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Paulo Moreira Silva', 'Initials': 'PMS', 'LastName': 'Dantas', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Breno Guilherme de Araújo Tinôco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176058']
1880,32825509,Continuous Compared to Accumulated Walking-Training on Physical Function and Health-Related Quality of Life in Sedentary Older Persons.,"The present study aimed to analyze the impact of overground walking interval training (WIT) in a group of sedentary older adults, comparing two different dose-distributions. In this quasi-experimental and longitudinal study, we recruited twenty-three sedentary older adults (71.00 ± 4.10 years) who were assigned to two groups of WIT. The continuous group (CWIT) trained for 60 min/session in the morning, while the accumulated group (AWIT) performed the same duration and intensity of exercise, but it was distributed twice a day (30 min in the morning and 30 more in the afternoon). After 15 weeks of an equal external-load training (3 days/week), Bonferroni post-hoc comparisons revealed significant ( p  < 0.050) and similar large improvements in both groups in cardiorespiratory fitness and lower limb strength; even larger gains in preferred walking speed and instrumental daily life activity, which was slightly superior for CWIT; and improvements in agility, which were moderate for CWIT and large for AWIT. However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life. Although both training protocols induced a general significant improvement in physical function in older adults, our results showed that the accumulative strategy should be recommended when health-related quality of life is the main target, and the continuous strategy should be recommended when weakness may be a threat in the short or medium term.",2020,"However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life.","['twenty-three sedentary older adults (71.00 ± 4.10 years) who were assigned to two groups of WIT', 'older adults', 'Sedentary Older Persons', 'a group of sedentary older adults']","['Accumulated Walking-Training', 'overground walking interval training (WIT']","['Physical Function and Health-Related Quality of Life', 'physical function', 'walking speed and instrumental daily life activity', 'health-related quality of life', 'executive function', 'cardiorespiratory fitness and lower limb strength']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",23.0,0.0179847,"However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life.","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Mari Carmen', 'Initials': 'MC', 'LastName': 'Gómez-Cabrera', 'Affiliation': 'Freshage Research Group, Department of Physiology, faculty of Medicine, University of Valencia, CIBERFES, Fundación Investigación Hospital Clínico Universitario/INCLIVA, 46010 Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176060']
1881,32825535,Physical Activity Counseling for Adults with Hypertension: A Randomized Controlled Pilot Trial.,"The effect of physical activity counseling (PAC) in hypertensive adults is unclear. This study investigated the effect of PAC on blood pressure (BP), physical activity level, sitting time, metabolic profile, and body composition in hypertensive adults. Twenty-two hypertensive adults (48.8 ± 7.3 years) participated in this pilot trial. The 12-week PAC was based on the 5 A's model considering the FITT principle (Frequency, Intensity, Time, and Type) of physical activity. The control group received instructions about FITT in one face-to-face meeting at baseline. Pedometer-measured physical activity, sitting time, resting and ambulatory BP, metabolic profile (cholesterol, triglycerides, fasting glucose), and body composition (fat mass, abdominal fat, fat free mass) were assessed. The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902;  p  = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day;  p  = 0.059) than the control group. No changes were observed in BP, metabolic profile, and body composition ( p >  0.05). In conclusion, 12 weeks of a PAC program based on the 5 A's model resulted in a modest increase of ~800 steps per day and a trend to decrease ~2 h/day in sitting time, but there were no associated reduction in BP and improvements in metabolic and body composition.",2020,The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902;  p  = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day;  p  = 0.059) than the control group.,"['Adults with Hypertension', 'Twenty-two hypertensive adults (48.8 ± 7.3 years', 'hypertensive adults']","['physical activity counseling (PAC', 'Physical Activity Counseling', 'PAC', 'instructions about FITT']","['Pedometer-measured physical activity, sitting time, resting and ambulatory BP, metabolic profile (cholesterol, triglycerides, fasting glucose), and body composition (fat mass, abdominal fat, fat free mass', 'BP and improvements in metabolic and body composition', 'lower sitting time', 'blood pressure (BP), physical activity level, sitting time, metabolic profile, and body composition', 'BP, metabolic profile, and body composition']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0060398', 'cui_str': 'FITT'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",22.0,0.0226444,The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902;  p  = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day;  p  = 0.059) than the control group.,"[{'ForeName': 'Altieres E', 'Initials': 'AE', 'LastName': 'Sousa Junior', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Geovani A D', 'Initials': 'GAD', 'LastName': 'Macêdo', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schwade', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'Sócrates', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'José W', 'Initials': 'JW', 'LastName': 'Alves', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Farias-Junior', 'Affiliation': 'Graduate Program in Psychobiology, Federal University of Rio Grande do Norte, Natal 59064-741, RN, Brazil.'}, {'ForeName': 'Yuri A', 'Initials': 'YA', 'LastName': 'Freire', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Telma M A M', 'Initials': 'TMAM', 'LastName': 'Lemos', 'Affiliation': 'Department of Clinical and Toxicological Analysis, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'Rodrigo A V', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'Eduardo C', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176076']
1882,32825555,Beneficial Effects of Interactive Physical-Cognitive Game-Based Training on Fall Risk and Cognitive Performance of Older Adults.,"Physical and cognitive declines are significant risk factors for falls. Promising evidence suggests that combined physical-cognitive training would be an effective fall risk reduction and cognitive improvement intervention. However, a limited number of studies have been conducted and findings have been inconclusive. This study investigated the effects of interactive physical-cognitive game-based training on the fall risk and cognitive performance of older adults. Forty participants were randomly allocated to the intervention (n = 20) and control (n = 20) groups. Participants in the intervention group performed a 1 h session, 3 times a week for 12 weeks of the interactive physical-cognitive game-based training program. Fall risk (Physiological Profile Assessment, PPA; and Timed Up and Go, TUG) and cognitive outcome (Montreal Cognitive Assessment, MoCA) were assessed at pre- and post-intervention. Thirty-nine participants (mean age = 69.81 ± 3.78 years) completed the study (97.5%). At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p  = 0.015), postural sway ( p  = 0.005), MoCA score ( p  = 0.001), and TUG-dual task ( p  = 0.045) compared to controls. In conclusion, the interactive physical-cognitive, game-based training was effective in reducing physiological fall risk and improving cognitive function in community-dwelling older adults.",2020,"At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p  = 0.015), postural sway ( p  = 0.005), MoCA score ( p  = 0.001), and TUG-dual task ( p  = 0.045) compared to controls.","['Older Adults', 'older adults', 'community-dwelling older adults', 'Thirty-nine participants (mean age = 69.81 ± 3.78 years) completed the study (97.5', 'Forty participants']","['Interactive Physical-Cognitive Game-Based Training', 'interactive physical-cognitive game-based training program', 'interactive physical-cognitive game-based training', 'interactive physical-cognitive, game-based training', 'combined physical-cognitive training']","['Fall risk (Physiological Profile Assessment, PPA; and Timed Up and Go, TUG) and cognitive outcome (Montreal Cognitive Assessment, MoCA', 'MoCA score', 'TUG-dual task', 'PPA fall risk score', 'fall risk and cognitive performance', 'Fall Risk and Cognitive Performance', 'physiological fall risk and improving cognitive function', 'postural sway']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031495', 'cui_str': 'Phenylpropanolamine'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]",40.0,0.0128531,"At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p  = 0.015), postural sway ( p  = 0.005), MoCA score ( p  = 0.001), and TUG-dual task ( p  = 0.045) compared to controls.","[{'ForeName': 'Kochaphan', 'Initials': 'K', 'LastName': 'Phirom', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Teerawat', 'Initials': 'T', 'LastName': 'Kamnardsiri', 'Affiliation': 'Department of Digital Game, College of Arts, Media, and Technology, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17176079']
1883,32825556,"Acute Epigallocatechin-3-Gallate Supplementation Alters Postprandial Lipids after a Fast-Food Meal in Healthy Young Women: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.","A high-fat fast-food meal negatively impacts postprandial metabolism even in healthy young people. In experimental studies, epigallocatechin-3-gallate (EGCG), a bioactive compound present in green tea, has been described as a potent natural inhibitor of fatty acid synthase. Thus, we sought to evaluate the effects of acute EGCG supplementation on postprandial lipid profile, glucose, and insulin levels following a high-fat fast-food meal. Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2  were enrolled in a randomized, double-blind, placebo-controlled crossover study. Participants ingested capsules containing 800 mg EGCG or placebo immediately before a typical fast-food meal rich in saturated fatty acids. Blood samples were collected at baseline and then at 90 and 120 min after the meal. The EGCG treatment attenuated postprandial triglycerides ( p  = 0.029) and decreased high-density lipoprotein cholesterol (HDL-c) ( p  = 0.016) at 120 min. No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels. The incremental area under the curve (iAUC) for glucose was decreased by EGCG treatment ( p  < 0.05). No difference was observed in the iAUC for triglycerides and HDL-c. In healthy young women, acute EGCG supplementation attenuated postprandial triglycerides and glucose but negatively impacted HDL-c following a fast-food meal.",2020,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","['Healthy Young Women', 'healthy young people', 'Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2', 'healthy young women']","['Placebo', 'EGCG', 'acute EGCG supplementation', 'EGCG or placebo', 'epigallocatechin-3-gallate (EGCG', 'Acute Epigallocatechin-3-Gallate Supplementation', 'placebo']","['incremental area under the curve (iAUC) for glucose', 'high-density lipoprotein cholesterol (HDL-c', 'iAUC for triglycerides and HDL-c', 'postprandial triglycerides', 'Blood samples', 'postprandial lipid profile, glucose, and insulin levels', 'total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels', 'postprandial triglycerides and glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",14.0,0.329711,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","[{'ForeName': 'Alcides C', 'Initials': 'AC', 'LastName': 'de Morais Junior', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Schincaglia', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Passarelli', 'Affiliation': 'Laboratório de Lípides (LIM 10), Hospital das Clínicas (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo 05403-900, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}]",Nutrients,['10.3390/nu12092533']
1884,32825565,The Prototypes of Tobacco Users Scale (POTUS) for Cigarette Smoking and E-Cigarette Use: Development and Validation.,"Endorsing prototypes of cigarette smokers predicts cigarette smoking, but less is known about prototypes of users of other tobacco products. Our study sought to establish the reliability and validity of a measure of prototypes of smokers and e-cigarette users. Participants were from a national survey of smokers and non-smokers ( n  = 1414), a randomized clinical trial (RCT) of adult smokers ( n  = 2149), and adolescent children of adults in the trial ( n  = 112). The Prototypes of Tobacco Users Scale (POTUS) has four positive adjectives (cool, sexy, smart, and healthy) and four negative adjectives (disgusting, unattractive, immature, and inconsiderate) describing cigarette smokers and e-cigarette users. Confirmatory factor analyses identified a two-factor solution. The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up). In the RCT, smokers more often agreed with negative prototypes for smokers than for e-cigarette users (mean = 2.03 vs. 1.67,  p  < 0.05); negative prototypes at baseline were also associated with more forgoing of cigarettes and making a quit attempt at the end of the trial (Week 4 follow-up). The POTUS may be useful to public health researchers seeking to design interventions that reduce tobacco initiation or cessation through the manipulation of tobacco user prototypes.",2020,"The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up).","['smokers and e-cigarette users', 'Participants were from a national survey of smokers and non-smokers ( n  = 1414), a randomized clinical trial (RCT) of adult smokers ( n  = 2149), and adolescent children of adults in the trial ( n  = 112']",[],['internal consistency reliability'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319548', 'cui_str': '112'}]",[],"[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0224771,"The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up).","[{'ForeName': 'Eboneé N', 'Initials': 'EN', 'LastName': 'Butler', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599 USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'May S', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'RTI International, Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Hart', 'Initials': 'H', 'LastName': 'Blanton', 'Affiliation': 'Department of Communication, Texas A&M University, College Station, TX 77843, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176081']
1885,32825588,TILs Immunophenotype in Breast Cancer Predicts Local Failure and Overall Survival: Analysis in a Large Radiotherapy Trial with Long-Term Follow-Up.,"AIM


To determine the prognostic significance of the immunophenotype of tumour-infiltrating lymphocytes (TILs) within a cohort of breast cancer patients with long-term follow-up.
METHODS


Multiplexed immunofluorescence and automated image analysis were used to assess the expression of CD3, CD8, CD20, CD68, Fox P3, PD-1 and PD-L1 in a clinical trial of local excision and radiotherapy randomised to a cavity boost or not ( n  = 485, median follow-up 16 years). Kaplan-Meier and Cox multivariate analysis (MVA) methodology were used to ascertain relationships with local recurrence (LR), overall survival (OS) and disease-free survival (DFS). NanoString BC360 gene expression panel was applied to a subset of luminal patients to identify pathways associated with LR.
RESULTS


LR was predicted by low CD8 in MVA in the whole cohort (HR 2.34, CI 1.4-4.02,  p  = 0.002) and luminal tumours (HR 2.19, CI 1.23-3.92,  p  = 0.008) with associations with increased stromal components, decreased Tregs (FoxP3), inflammatory chemokines and SOX2. Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
CONCLUSIONS


Immunophenotype adds further prognostic data to help further stratify risk of LR and OS even in TILs low-luminal tumours.",2020,"Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
",['breast cancer patients with long-term'],"['Immunophenotype', 'local excision and radiotherapy']","['local recurrence (LR), overall survival (OS) and disease-free survival (DFS', 'luminal tumours', 'Poor OS', 'low CD8 in MVA', 'expression of CD3, CD8, CD20, CD68, Fox P3, PD-1 and PD-L1', 'stromal components, decreased Tregs (FoxP3), inflammatory chemokines and SOX2']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0079611', 'cui_str': 'Immunophenotyping'}, {'cui': 'C0278259', 'cui_str': 'Local excision'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0052712', 'cui_str': 'AVM protocol'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0016632', 'cui_str': 'Fox-Fordyce disease'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1568630', 'cui_str': 'SOX2 protein, human'}]",,0.133403,"Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
","[{'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Millar', 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Browne', 'Affiliation': 'Cancer Care Centre, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Slapetova', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shang', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Bradshaw', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ann Brauer', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, Royal Prince Alfred Hospital, Camperdown, NSW 2217, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Beretov', 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Whan', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Graham', 'Affiliation': 'Faculty of Medicine, St George & Sutherland Clinical School, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}]",Cancers,['10.3390/cancers12092365']
1886,32825677,A Comparison of the Acute Effects of Different Forms of Yoga on Physiological and Psychological Stress: A Pilot Study.,"Yoga is a frequently recommended stress management strategy; however, the acute stress response to varying types of yoga are not fully clear. Thus, the purpose of this study was to compare the acute effects of meditative and power yoga on indices of physiological and psychological stress. In a crossover counterbalanced design, physically active females (n = 13; age = 20.8 yrs ± 0.8, height = 164.5 cm ± 6.1, body mass = 65.0 kg ± 13.8) who did not regularly participate in yoga or mindful training enrolled in this study. Participants completed two visits each, with a standardized instructional-video 30-min yoga session with either A) meditative (Hatha style) yoga or B) power (Vinyasa style) yoga. Prior to and immediately after each yoga bout, psychological stress was assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, and salivary cortisol samples were obtained to measure indices of physiological stress. State anxiety scores were significantly lower following meditative yoga ( p  = 0.047) but were not different following power yoga ( p  = 0.625). Salivary cortisol levels were significantly lower following meditative yoga ( p  = 0.020) but not following power yoga ( p  = 0.242). Results indicate that acute engagement in meditative yoga decreases markers of psychological and physiological stress, while power yoga does not impart a significant stress-relieving benefit. Findings indicate that differing types of yoga may have various stress-relieving capabilities and should be considered by individuals seeking anxiolytic benefits.",2020,State anxiety scores were significantly lower following meditative yoga ( p  = 0.047) but were not different following power yoga ( p  = 0.625).,"['physically active females (n = 13; age = 20.8 yrs ± 0.8, height = 164.5 cm ± 6.1, body mass = 65.0 kg ± 13.8) who did not regularly participate in yoga or mindful training enrolled in this study']","['meditative and power yoga', 'standardized instructional-video 30-min yoga session with either A) meditative (Hatha style) yoga or B) power (Vinyasa style) yoga']","['State-Trait Anxiety Inventory (STAI) questionnaire, and salivary cortisol samples', 'Salivary cortisol levels', 'State anxiety scores', 'psychological and physiological stress']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}]",13.0,0.0164619,State anxiety scores were significantly lower following meditative yoga ( p  = 0.047) but were not different following power yoga ( p  = 0.625).,"[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'McKenzie', 'Initials': 'M', 'LastName': 'McClanahan', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McArthur Warren', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Rogers', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ballmann', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176090']
1887,32825814,Elastic pneumatic tourniquet cuff can reduce postoperative thigh pain after total knee arthroplasty: a prospective randomized trial.,"BACKGROUND


Tourniquet use is associated with complications such as thigh pain, skin problems, and deep vein thrombosis (DVT). This prospective study aimed to evaluate the efficacy and safety of the pneumatic tourniquet system using an elastic cuff and limb occlusion pressure (LOP) in total knee arthroplasty (TKA). The hypothesis of this study was that an elastic cuff tourniquet would result in less postoperative thigh pain after TKA.
METHODS


This prospective randomized controlled trial involved a total of 98 patients who underwent primary TKA. They were randomized into two groups: tourniquet system using an elastic cuff and LOP group (Group E) and tourniquet system using a conventional-cuff and LOP group (Group C). Outcomes including postoperative thigh pain assessed using a visual analog scale (VAS), serum muscle enzymes, recommended tourniquet pressure (RTP), bloodlessness of surgical field, surgical time, incidence of DVT, and the frequency of rescue analgesic use after surgery, were compared between groups.
RESULTS


Patients in Group E experienced significantly less thigh pain compared to those in Group C on postoperative day 4 (P = 0.01) and day 7 (P = 0.04). The difference between RTP and systolic blood pressure was significantly lower in Group E (P = 0.045). One case of thigh DVT was found in Group E, while no such cases were found in Group C. One and two cases of poor bloodless surgical fields were observed in Group E and Group C, respectively. There was no significant difference in surgical time, levels of serum muscle enzymes, and the frequency of rescue analgesic use between the two groups.
CONCLUSIONS


The pneumatic tourniquet system using an elastic cuff and LOP reduced early postoperative thigh pain more effectively than did the tourniquet system using a conventional cuff and LOP.
TRIAL REGISTRATION


# KCT0003149 . Registered August 17, 2018 - Retrospectively registered.",2020,The difference between RTP and systolic blood pressure was significantly lower in Group E (P = 0.045).,"['Registered August 17, 2018 - Retrospectively registered', 'total knee arthroplasty (TKA', 'after total knee arthroplasty', '98 patients who underwent primary TKA']","['tourniquet system using an elastic cuff and LOP group (Group E) and tourniquet system using a conventional-cuff and LOP', 'Elastic pneumatic tourniquet cuff', 'elastic cuff and limb occlusion pressure (LOP', 'pneumatic tourniquet system', 'pneumatic tourniquet system using an elastic cuff and LOP']","['postoperative thigh pain', 'RTP and systolic blood pressure', 'thigh DVT', 'thigh pain', 'surgical time, levels of serum muscle enzymes, and the frequency of rescue analgesic use', 'efficacy and safety', 'bloodless surgical fields', 'postoperative thigh pain assessed using a visual analog scale (VAS), serum muscle enzymes, recommended tourniquet pressure (RTP), bloodlessness of surgical field, surgical time, incidence of DVT, and the frequency of rescue analgesic use after surgery']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0180209', 'cui_str': 'Tourniquet cuff'}, {'cui': 'C3880990', 'cui_str': 'Pneumatic tourniquet system'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0241374', 'cui_str': 'Thigh pain'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141895', 'cui_str': 'Muscle enzyme'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",98.0,0.0518565,The difference between RTP and systolic blood pressure was significantly lower in Group E (P = 0.045).,"[{'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Myung Chul', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea. oshawks7@snu.ac.kr.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03579-6']
1888,32825817,The effect of intraoperative goal-directed crystalloid versus colloid administration on perioperative inflammatory markers - a substudy of a randomized controlled trial.,"BACKGROUND


Excessive perioperative fluid administration may result in iatrogenic endothelial dysfunction and tissue edema, transducing inflammatory markers into the bloodstream. Colloids remain longer in the circulation, requiring less volume to reach similar hemodynamic endpoints compared to crystalloids. Thus, we tested the hypothesis that a goal-directed colloid regimen attenuates the inflammatory response compared to a goal-directed crystalloid regime.
METHODS


Patients undergoing moderate- to high-risk open abdominal surgery were randomly assigned to goal-directed lactated Ringer's solution (n = 58) or a hydroxyethyl starch 6% 130/0.4 (n = 62) fluid regimen. Our primary outcome was perioperative levels of pro- and anti-inflammatory cytokines. Secondary outcome was perioperative levels of white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT) and lipopolysaccharide-binding protein (LBP). Measurements were performed preoperatively, immediate postoperatively, on postoperative day one, two and four.
RESULTS


The areas under the curve of Interleukin (IL) 6 (p = 0.60), IL 8 (p = 0.46), IL 10 (p = 0.68) and tumor necrosis factor α (p = 0.47) levels did not differ significantly between the groups. WBC, CRP and PCT values were also comparable. LBP, although significantly higher in the crystalloid group, remained in the normal range. Patients assigned to crystalloids received a median (IQR) amount of 3905 mL (2880-5288) of crystalloid. Patients assigned to colloids received 1557 mL (1207-2116) of crystalloid and 1250 mL (750-1938) of colloid.
CONCLUSION


Cytokine and inflammatory marker levels did not differ between goal-directed crystalloid and colloid administration after moderate to high-risk abdominal surgery.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT00517127 ). Registered 16th August 2007.",2020,"The areas under the curve of Interleukin (IL) 6 (p = 0.60), IL 8 (p = 0.46), IL 10 (p = 0.68) and tumor necrosis factor α (p = 0.47) levels did not differ significantly between the groups.",['Patients undergoing moderate- to high-risk open abdominal surgery'],"['crystalloid', 'hydroxyethyl starch', 'intraoperative goal-directed crystalloid versus colloid administration', ""goal-directed lactated Ringer's solution""]","['perioperative levels of white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT) and lipopolysaccharide-binding protein (LBP', 'LBP', 'CRP and PCT values', 'tumor necrosis factor α', 'perioperative levels of pro- and anti-inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.436471,"The areas under the curve of Interleukin (IL) 6 (p = 0.60), IL 8 (p = 0.46), IL 10 (p = 0.68) and tumor necrosis factor α (p = 0.47) levels did not differ significantly between the groups.","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Obradovic', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'Department of Outcomes Research and General Anesthesiology, Anesthesiology Institute, 9500 Euclid Avenue, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. barbara.kabon@meduniwien.ac.at.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Roth', 'Affiliation': 'Department of Anesthesiology and General Intensive Care, Franziskus Hospital, Nikolsdorfergasse 32, 1050, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kimberger', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zotti', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Ahamed', 'Initials': 'A', 'LastName': 'Bayoumi', 'Affiliation': 'Department of Gynecology, Klinik Ottakring, Montleartstrasse 37, 1160, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Stift', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]",BMC anesthesiology,['10.1186/s12871-020-01126-3']
1889,32825845,"TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol-a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of ""high-intensity"" vs. ""low-intensity"" smoking cessation intervention in active smokers with chronic obstructive pulmonary disease.","BACKGROUND


Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15-20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
METHODS


This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, ""low intensity"" group) or an intervention (""high-intensity"" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and ""buddy-matching"" (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months.
DISCUSSION


The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019.",2020,"The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
","['600 active smokers with COPD', 'active smokers with COPD', 'chronic obstructive pulmonary disease (COPD', 'COPD patients', 'active smokers with chronic obstructive pulmonary disease']","['high-intensity"" vs. ""low-intensity"" smoking cessation intervention', 'standard treatment (guideline-based municipal smoking cessation program, ""low intensity"" group) or an intervention (""high-intensity"" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and ""buddy-matching"" (smoker matched with COPD patient who has ceased smoking', 'low-intensity intervention', 'high-intensity intervention', 'pharmacological smoking cessation']","['anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation', 'quality of life and longevity', 'smoking cessation rates']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}]",600.0,0.0837198,"The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
","[{'ForeName': 'Mohamad Isam', 'Initials': 'MI', 'LastName': 'Saeed', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark. mohamad.isam.saeed.02@regionh.dk.'}, {'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Eklöf', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Pisinger', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Tønnesen', 'Affiliation': 'Department of Respiratory Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Hoyer', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie Lavesen', 'Initials': 'ML', 'LastName': 'Karlsson', 'Affiliation': 'Department of Respiratory and Infectious Medicine, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Charlotte Sandau', 'Initials': 'CS', 'LastName': 'Bech', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Marså', 'Affiliation': 'Palliation Unit, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brøndum', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Munk', 'Affiliation': 'Rygestopcaféen, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Raaschou', 'Affiliation': 'Patient Representative, Hellerup, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Browatzski', 'Affiliation': 'Department of Respiratory and Infectious Medicine, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Lütken', 'Affiliation': 'Rygestopkonsulenterne ApS, Hillerød, Denmark.'}, {'ForeName': 'Jens-Ulrik Stæhr', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}]",Trials,['10.1186/s13063-020-04653-z']
1890,32825977,Persian manual therapy method for chronic low-back pain with lumbar radiculopathy; a randomized controlled trial.,"BACKGROUND


Manual therapy is a non-surgical approach for management of musculoskeletal symptoms. This study investigated safety and efficacy of a Persian manual therapy method (Fateh technique) for management of chronic low-back pain (LBP) and radiculopathy.
METHODS


In this controlled trial, 52 eligible patients with chronic LBP and lumbar radiculopathy were randomly assigned into two intervention groups; one received a 16-min soft tissue manipulation for four weekly sessions and did two daily home active exercises. The other group only did the two daily exercises for four weeks. Roland-Morris disability score, Visual Analogue Scale scores of LBP, radiculopathy and paresthesia, and finger-to-floor test result were assessed at the baseline, and in fourth and eighth weeks of trial.
RESULTS


Data of 48 participants was analyzed. Distributions of age, sex, and duration of symptoms in two groups were the same. Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters. Compared with home exercise, Fateh technique was associated with greater changes in all outcomes. No adverse event has occurred.
CONCLUSIONS


Fateh technique is safe and effective for management of LBP and radiculopathy in patients without severe progressive symptoms.",2020,"Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters.","['52 eligible patients with chronic LBP and lumbar radiculopathy', 'chronic low-back pain with lumbar radiculopathy', '48 participants was analyzed', 'patients without severe progressive symptoms']","['16-min soft tissue manipulation for four weekly sessions and did two daily home active exercises', 'Persian manual therapy method (Fateh technique']","['pain, radiculopathy, paresthesia, and disability', 'Roland-Morris disability score, Visual Analogue Scale scores of LBP, radiculopathy and paresthesia, and finger-to-floor test result', 'safety and efficacy', 'body flexibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",52.0,0.117942,"Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters.","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Sanei', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Roozafzai', 'Affiliation': 'Digestive Disease Research Institute, Shariati Hopital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shobeir Rostami', 'Initials': 'SR', 'LastName': 'Abousaidi', 'Affiliation': 'Department of Orthopedics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Hamze', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir-Masoud', 'Initials': 'AM', 'LastName': 'Negarestani', 'Affiliation': 'Department of Radiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mokaberinejad', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: rmokaberi@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.015']
1891,32825981,A randomized clinical trial for the effect of static stretching and strengthening exercise on pelvic tilt angle in LBP patients.,"BACKGROUND


Stretching and strengthening exercises are commonly used to improve muscle shortness of the hamstring as any tension in this muscle can have an effect on the pelvic posture. Thus, the aim of this study was to evaluate the effects of two methods of improving short hamstring on the angle of pelvic tilt in LBP sufferers.
METHODS


Forty-five low back pain patients aged 19-59 years with hamstring tightness participated in this clinical trial. The patients were categorized randomly into three groups: 1- static stretching, 2-strengthening exercise and 3-control group. The two intervention groups received physical therapy and special exercise program thrice a week in a total of 12 sessions, while the control group received only conventional physical therapy. Before and after the treatment implementation, the pelvic tilt and straight leg raising (SLR) degree were assessed for each group.
RESULT


After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups. In addition, no statistically significant correlation was observed between the pelvic tilt and SLR test [except for the strengthening exercise group (Pearson correlation coefficient = -0.54, P < 0.05)].
CONCLUSIONS


In LBP sufferers, both static stretching and strengthening of hamstring muscle in its lengthened position caused elongation and extensibility in the hamstring muscle and increased SLR test score, but did not change pelvic tilt angle.",2020,"After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups.","['LBP patients', 'Forty-five low back pain patients aged 19-59 years with hamstring tightness participated in this clinical trial', 'LBP sufferers']","['strengthening exercise', 'physical therapy and special exercise program', '1- static stretching, 2-strengthening exercise and 3-control group', 'control group received only conventional physical therapy', 'static stretching and strengthening exercise', 'Stretching and strengthening exercises']","['pelvic tilt angle', 'pelvic tilt and straight leg raising (SLR) degree', 'pelvic tilt and SLR test', 'pelvic tilt angle and SLR score changes', 'SLR test score']","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0207692,"After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups.","[{'ForeName': 'MohammadBagher', 'Initials': 'M', 'LastName': 'Shamsi', 'Affiliation': 'Rehabilitation and Sport Medicine Department, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: mbshamsi@yahoo.com.'}, {'ForeName': 'Soodeh', 'Initials': 'S', 'LastName': 'Shahsavari', 'Affiliation': 'Health Information Management Department, Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: soodeh_shahsavari@yahoo.com.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Safari', 'Affiliation': 'Research Management Office, Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: safari.ameneh0@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: maryam.mirzaee@kums.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.001']
1892,32825982,Effects of non-linear resistance training and curcumin supplementation on the liver biochemical markers levels and structure in older women with non-alcoholic fatty liver disease.,"BACKGROUND


With increasing age, non-alcoholic fatty liver disease is very common among women with low levels of physical activity. Nonlinear resistance training is one of the new methods to help patients who have low levels of physical activity. Curcumin is an herbal supplement that has anti-inflammatory effects. The present study aimed to examine the effects of nonlinear resistance training and curcumin supplementation on the liver structure and biochemical markers in obese older women with non-alcoholic fatty liver disease.
METHODS


Forty-five obese women with non-alcoholic fatty liver disease were randomly assigned into resistance training (RT), curcumin supplement (C), resistance training with curcumin supplement (RTC), and placebo (P) groups. The RT and RTC groups received 12-weeks of nonlinear resistance training while the C and P groups had a normal sedentary lifestyle. Daily, the C and RTC groups received a curcumin capsule while the P and RT groups were given a placebo capsule. Blood sampling and ultrasonography were taken before and after the protocol.
RESULTS


Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels significantly decreased in the RT and RTC groups (P ≤ 0.05) but not in the C and P groups (P > 0.05). Alkaline phosphatase (ALP), total bilirubin (TB) levels, platelet counts (PLT), and liver structure did not significantly change in all groups (P > 0.05). Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
CONCLUSION


12-week non-linear resistance training has beneficial effects on non-alcoholic fatty liver disease in older obese women.",2020,"Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
","['women with low levels of physical activity', 'Forty-five obese women with non-alcoholic fatty liver disease', 'older women with non-alcoholic fatty liver disease', 'older obese women', 'obese older women with non-alcoholic fatty liver disease']","['non-linear resistance training and curcumin supplementation', 'Resistance training alone and with curcumin supplementation', 'resistance training (RT), curcumin supplement (C), resistance training with curcumin supplement (RTC), and placebo', 'Nonlinear resistance training', 'nonlinear resistance training and curcumin supplementation', 'linear resistance training', 'nonlinear resistance training']","['Alkaline phosphatase (ALP), total bilirubin (TB) levels, platelet counts (PLT), and liver structure', 'liver function', 'Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels', 'liver structure and biochemical markers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}]",45.0,0.113311,"Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
","[{'ForeName': 'Baharak', 'Initials': 'B', 'LastName': 'Moradi Kelardeh', 'Affiliation': 'Phd Exercise Physiology, Sama Technical and Vocational Training College, Islamic Azad University, Esfahan (Khorasgan) Branch, Esfahan, Iran.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Rahmati-Ahmadabad', 'Affiliation': 'Department of Physical Education, Pardis Branch, Islamic Azad University, Pardis, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Farzanegi', 'Affiliation': 'Department of Exercise Physiology, Sari Branch, Islamic Azad University, Sari, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Helalizadeh', 'Affiliation': 'Department of Exercise Physiology, Sport Medicine Research Center, Sport Sciences Research Institute, Tehran, Iran.'}, {'ForeName': 'Mohammad-Ali', 'Initials': 'MA', 'LastName': 'Azarbayjani', 'Affiliation': 'Department of Exercise Physiology, Central Tehran Branch, Islamic Azad University, Tehran, Iran. Electronic address: m_azarbayjani@iauctb.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.021']
1893,32825983,Treatment of panic disorder by trigeminal nerve manipulation: A case series.,"This is a report on two cases of patients with acute severe panic disorder relieved of their symptoms by manual manipulations of the trigeminal nerve's alveolar branches. The manipulations were performed via the oral cavity during one session, or two consecutive sessions less than a week apart. No other effective treatment was administered prior, concurrently or since the time of the treatment. The recovery from panic disorder was immediate and lasted for the entire period of observation of three years. The authors used the same procedure and achieved identical clinical results treating ten other clients over a period of three years. This was not a planned experiment or randomized study. Rather, this report presents clinical evidence and the authors' hypothesis based on clinical data and literature review.",2020,The recovery from panic disorder was immediate and lasted for the entire period of observation of three years.,['patients with acute severe panic disorder'],['trigeminal nerve manipulation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}]","[{'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]",[],10.0,0.0143006,The recovery from panic disorder was immediate and lasted for the entire period of observation of three years.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Birstein', 'Affiliation': 'Pittsburgh Integrative Mental Health, 160 N. Craig St. Suite 212 Pittsburgh, PA, 15213, USA. Electronic address: birstein@gmail.com.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gusky', 'Affiliation': 'Pittsburgh Integrative Mental Health, 160 N. Craig St. Suite 212 Pittsburgh, PA, 15213, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.01.002']
1894,32825989,Osteopathic treatment leads to significantly greater reductions in chronic thoracic pain after CABG surgery: A randomised controlled trial.,"BACKGROUND


There are a number of long-term postoperative complications after coronary artery bypass graft (CABG) surgery. Pulmonary function is decreased by 12% and 30%-50% of the patients have chronic thoracic pain.
METHODS


This randomised controlled trial with two parallel groups aimed to explore the effectiveness of osteopathic treatments (OTs) on these conditions. The standard care (SC) group and the and OT group received a 12-week standard cardiac rehabilitation programme, which was supplemented with four OTs for the OT group only. The outcome assessors were blinded to the patients' allocation.
RESULTS


Eighty-two patients with median sternotomy after CABG surgery were randomly allocated in a 1:1 ratio (SC: n = 42, OT: n = 42). Slow vital capacity and pain intensity were measured at baseline and at 12 weeks and 52 weeks after surgery. Pain intensity was significantly lower in the OT group 12 weeks after surgery (3.6-0.80 vs. 2.6 to 1.2, p = 0.030). One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014). No significant changes between groups were found in pulmonary function. There were no adverse events reported.
CONCLUSIONS


From this study, it can be concluded that the addition of OT to exercise-based cardiac rehabilitation may lead to significantly greater reductions in thoracic pain after CABG surgery.
TRIAL REGISTRATION


This study was registered on ClinicalTrials.gov (NCT01714791).",2020,"One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014).",['Eighty-two patients with median sternotomy after CABG surgery'],"['standard cardiac rehabilitation programme', 'OT', 'coronary artery bypass graft (CABG) surgery', 'osteopathic treatments (OTs']","['chronic thoracic pain', 'Pulmonary function', 'pain intensity', 'Slow vital capacity and pain intensity', 'Pain intensity', 'thoracic pain', 'pulmonary function']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}]",82.0,0.255498,"One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014).","[{'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Roncada', 'Affiliation': 'Jessa Hospital, Heart Centre Hasselt, Hasselt, Belgium; Commission for Osteopathic Research, Practice and Promotion, Mechelen, Belgium. Electronic address: gert.roncada@telenet.be.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.03.004']
1895,32825990,Osteopathic treatment of patients with shoulder pain. A pragmatic randomized controlled trial.,"BACKGROUND


Shoulder complaints are common in the general population. Typically, the diagnosis of a specific pathology is lacking. The objective of this trial was to evaluate the effectiveness of an osteopathic treatment in patients suffering from shoulder pain.
METHODS


A pragmatic randomized controlled trial was conducted in patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS). Participants were identified from the general population in Germany and allocated by means of external randomization to an intervention group or a control group. Patients in the intervention group received five osteopathic treatments at intervals of two weeks. Treatment was custom tailored and based on osteopathic principles. Controls received their osteopathic treatment after an 8-week untreated waiting period. Primary outcome parameters were pain intensity and frequency, measured by VAS and Likert Scales. Secondary outcome parameters were shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36).
RESULTS


A total of 70 patients aged 25-70 years (average age 45.6 ± 13.4 years) were included, 36 in the intervention group and 34 in the control group. The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005). The proportion of participants with a low frequency of pain increased in the osteopathic group only (from 7 to 34 vs. 9 to 6 in the control group, p = 0.006), and the number of patients with a high frequency decreased in the osteopathic group only (from 29 to 2 vs. 25 to 28, p < 0.0005). Shoulder specific pain and disability also improved. The follow-up assessment in the intervention group showed further improvements.
CONCLUSIONS


Five osteopathic treatments over a period of eight weeks led to statistically significant and clinically relevant positive changes of pain and disability in patients suffering from shoulder pain.",2020,The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005).,"['patients suffering from shoulder pain', '70 patients aged 25-70 years (average age 45.6\xa0±\xa013.4 years) were included, 36 in the intervention group and 34 in the control group', 'patients with shoulder pain', 'patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS']","['control group', 'osteopathic treatment']","['average pain intensity (VAS', 'pain and disability', 'shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36', 'maximal pain intensity (VAS', 'Shoulder specific pain and disability', 'pain intensity and frequency, measured by VAS and Likert Scales', 'low frequency of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]",70.0,0.16424,The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005).,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schwerla', 'Affiliation': 'German Academy of Osteopathy, Research Commission, Gauting, Germany. Electronic address: f.schwerla@german-afo.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Hinse', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: torsten.hinse@gmx.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Klosterkamp', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: markus.klosterkamp@t-online.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmitt', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: osteopathie-schmitt@web.de.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Rütz', 'Affiliation': 'German Academy of Osteopathy, Research Commission, Gauting, Germany. Electronic address: m.ruetz@osteopathie-akademie.de.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Resch', 'Affiliation': 'German Institute for Health Research (DIG), Bad Elster, Germany. Electronic address: K.L.Resch@t-online.de.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.009']
1896,32825994,Neuromuscular activation analysis of the trunk muscles during hippotherapy sessions.,"INTRODUCTION


Hippotherapy allows the development of affective, sensory, motor, and cognitive areas, besides providing the practitioner with several movements and stimuli necessary for therapeutic progress. However, there is a limited amount of scientific evidence regarding the suitability of the mount material, mount type, and hippotherapy session duration, as well as regarding the activation of specific muscle groups during the practice and its applicability to activities of daily living.
OBJECTIVE


This study aimed to study the neuromuscular activation behavior of the iliocostalis, longissimus, multifidus, and upper trapezius muscles of children during four hippotherapy session time points using a functional task. It also compared two different mount materials for riding.
METHODOLOGY


A total of 30 children were randomly assigned to one of three groups: Saddle Hippotherapy Group, Blanket Hippotherapy Group, and Control Group. Data were collected with an electromyograph in a functional task that comprised trunk movements to pick up an object. Assessments took place at four times during the session.
RESULTS


There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session. The trapezius muscle showed increased neuromuscular activation after only 10 min. It continued to increase (but without a statistical difference) after and 20 and 30 min.
CONCLUSION


Hippotherapy promoted neuromuscular activation of the trunk muscles in children, assessed through a functional task, and was influenced by both session time and mount material. Specifically, the greater neuromuscular performance occurred when an exercise was performed using saddle and stirrup and lasted 30 min.",2020,"There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session.","['30 children', 'children during four hippotherapy session time points using a functional task']","['Saddle Hippotherapy Group, Blanket Hippotherapy Group, and Control Group', 'electromyograph', 'Hippotherapy']","['neuromuscular activation', 'neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles', 'neuromuscular performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0180677', 'cui_str': 'Electromyograph'}]","[{'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}]",30.0,0.0185116,"There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session.","[{'ForeName': 'Júlio Ribeiro', 'Initials': 'JR', 'LastName': 'Bravo Gonçalves Junior', 'Affiliation': 'Federal University of Viçosa, Brazil. Electronic address: julioebravo@yahoo.com.br.'}, {'ForeName': 'André Gustavo', 'Initials': 'AG', 'LastName': 'Fernandes de Oliveira', 'Affiliation': 'Federal University of Juiz de Fora, Brazil.'}, {'ForeName': 'Silvia Almeida', 'Initials': 'SA', 'LastName': 'Cardoso', 'Affiliation': 'Federal University of Viçosa, Brazil.'}, {'ForeName': 'Kamila Gabriela', 'Initials': 'KG', 'LastName': 'Jacob', 'Affiliation': 'Dinâmica of Vale of Piranga of Ponte Nova University, Brazil.'}, {'ForeName': 'Lucas Vilas', 'Initials': 'LV', 'LastName': 'Boas Magalhães', 'Affiliation': 'Federal University of Viçosa, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.029']
1897,32825996,Effects of dry needling on symptomatic hallux valgus: A randomized single blind clinical trial.,"OBJECTIVES


The purpose of the present study was to determine the short and medium effects of dry needling (DN) on myofascial trigger points (MTrPs) in individuals with symptomatic hallux valgus (SHV).
METHODS


A total of 30 female volunteers, aged 25-60, with hallux valgus (HV) were randomly divided into two groups: DN group (n = 15) and control group (n = 15) who received sham dry needling. The outcome measures were pain intensity (Visual Analogue Scale, VAS), Foot Function Index (FFI), hallux valgus angle (HVA), and first metatarsophalangeal joint radiography.
RESULTS


At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05). These findings were maintained for a week and a month during follow-ups.
CONCLUSION


According to the findings, dry needling can be recommended for improving first metatarsophalangeal joint alignment in the mild to moderate SHV individuals.",2020,"At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05).","['30 female volunteers, aged 25-60, with hallux valgus (HV', 'symptomatic hallux valgus', 'individuals with symptomatic hallux valgus (SHV']","['dry needling', 'DN group (n\xa0=\xa015) and control group (n\xa0=\xa015) who received sham dry needling', 'dry needling (DN']","['pain intensity and foot function', 'myofascial trigger points (MTrPs', 'pain intensity (Visual Analogue Scale, VAS), Foot Function Index (FFI), hallux valgus angle (HVA), and first metatarsophalangeal joint radiography']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal joint structure'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]",30.0,0.0274087,"At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05).","[{'ForeName': 'Aliye Sadat', 'Initials': 'AS', 'LastName': 'Kharazmi', 'Affiliation': 'School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Okhovatian', 'Affiliation': 'Physiotherapy Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: farshadokhovatian1965@gmail.com.'}, {'ForeName': 'Alireza Akbarzadeh', 'Initials': 'AA', 'LastName': 'Baghban', 'Affiliation': 'Proteomics Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh Mohammadi', 'Initials': 'MM', 'LastName': 'Kojidi', 'Affiliation': 'Physiotherapy Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Azimi', 'Affiliation': 'Department of English Language Teaching, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.016']
1898,32826000,"The effectiveness of biomechanical taping and Kinesiotaping on shoulder pain, active range of motion and function of participants with Trapezius Myalgia: A randomized controlled trial.","BACKGROUND


Trapezius Myalgia (TM) is characterized by shoulder pain and dysfunction. Kinesio Taping is commonly used in symptom management of TM. Biomechanical Taping (BMT), a novel intervention, may provide equally effective management.
OBJECTIVES


This paper reports on the effectiveness of Biomechanical Taping compared with Kinesio Taping in improving shoulder pain, active range of motion (AROM), and function.
METHODS


Two groups of participants with TM were recruited through simple random sampling of participants from nine call centers and purposively-sampled participants from one fast-food chain and one community based rehabilitation center in Manila, Philippines. Participants were randomly allocated to either Kinesio Taping or biomechanical taping group in a double-blind clinical trial. Irrespective of the type of taping, participants performed gentle passive stretching of upper trapezius for six times each held for 30 s on Days 1, 3, and 5. On Days 2 and 4, participants performed gentle passive stretch of upper trapezius three times a day. Pre- and post-intervention measures were taken of Visual Analogue Scale for pain intensity, AROM for shoulder movement, and Disability of Arm, Shoulder, and Hand for function.
RESULTS


Of 68 participants, 62 had shoulder symptoms secondary to TM. Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
CONCLUSION


Biomechanical Taping appears to be as effective as Kinesio Taping in the short term in decreasing pain and improving function of individuals with TM. Both taping techniques did not restrict shoulder AROM of included participants.
MESH TERMS


Athletic Tape, Myalgia, Pain Measurements, Shoulder Pain NON-MESH TERMS: Biomechanical Taping Technique.",2020,"Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
","['Two groups of participants with TM were recruited through simple random sampling of participants from nine call centers and purposively-sampled participants from one fast-food chain and one community based rehabilitation center in Manila, Philippines', '68 participants, 62 had shoulder symptoms secondary to TM', 'participants with Trapezius Myalgia']","['Biomechanical Taping', 'MESH', 'Kinesio Taping or biomechanical taping', 'Biomechanical Taping (BMT', 'biomechanical taping and Kinesiotaping', 'Biomechanical Taping Technique', 'Shoulder Pain NON-MESH TERMS', 'Kinesio Taping']","['Visual Analogue Scale for pain intensity, AROM for shoulder movement, and Disability of Arm, Shoulder, and Hand for function', 'Athletic Tape, Myalgia, Pain Measurements', 'shoulder pain, active range of motion and function', 'shoulder pain, active range of motion (AROM), and function', 'Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C4277665', 'cui_str': 'Call Center'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2350263', 'cui_str': 'Orthotic Tape'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",68.0,0.164617,"Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
","[{'ForeName': 'Valentin C', 'Initials': 'VC', 'LastName': 'Dones Iii', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines; Center for Health Research and Movement Science, College of Rehabilitation Sciences, University of Santo Tomas, Philippines. Electronic address: vcdones@ust.edu.ph.'}, {'ForeName': 'Jocel M', 'Initials': 'JM', 'LastName': 'Regino', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines; Center for Health Research and Movement Science, College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Nicole Trizia S', 'Initials': 'NTS', 'LastName': 'Esplana', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Ivan Rafael V', 'Initials': 'IRV', 'LastName': 'Rivera', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Melissa Kaye R', 'Initials': 'MKR', 'LastName': 'Tomas', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.004']
1899,32826001,The effect of osteopathic manual therapy with breathing retraining on cardiac autonomic measures and breathing symptoms scores: A randomised wait-list controlled trial.,"BACKGROUND


Breathing retraining and manual therapy (MT), delivered independently or together, influence autonomic activity, and improve symptoms in patients with chronic conditions. This study evaluated the effects of breathing retraining and osteopathic MT on cardiac autonomic measures and breathing symptoms during spontaneous breathing in healthy active adults.
METHODS


Participants (n = 18) received breathing retraining and four, weekly manual therapy sessions, randomised to start immediately, or after 6-week delay. Heart-rate (HR) variability was assessed as a 7-day average of waking 6-min electrocardiograms, using time (logarithm of root-mean-square of successive differences; LnRMSSD) and frequency domain (logarithm of high-frequency; LnHF) measures. Recordings were taken before, one week following intervention or delay, and then following the later intervention for those with delayed starts. Changes were compared between those who received and had yet to receive the intervention, and before and after treatment for the whole cohort.
RESULTS


Following the intervention, HR-variability measures increased 4% overall (Effect Sizes: 1.0-1.1) for the whole cohort. Between-group analyses showed that the immediate-start group increased more than the delayed start group: LnRMSSD 0.27 (0.02-0.52; 95%CI) ln.ms, and LnHF 0.41 (-0.01-0.84) ln.ms 2  for immediate start; compared with LnRMSSD -0.09 (-0.29-0.11) ln.ms, and LnHF -0.19 (-0.59-0.22) ln.ms 2  (P = 0.02-0.03 for interaction) for delayed start. Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
CONCLUSION


A 6-week osteopathic treatment consisting of breathing retraining and MT is beneficial in raising HR-variability compared to no treatment, and may induce favourable (parasympathetic over sympathetic) autonomic modulation.
TRIAL REGISTRATION


ACTRN12614001119684.",2020,"Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
","['Participants (n\xa0=\xa018) received', 'patients with chronic conditions', 'healthy active adults']","['breathing retraining and osteopathic MT', 'breathing retraining and four, weekly manual therapy sessions', 'osteopathic manual therapy with breathing retraining', 'breathing retraining', 'Breathing retraining and manual therapy (MT']","['Resting HR', 'cardiac autonomic measures and breathing symptoms scores', 'HR-variability measures', '7-day average of waking 6-min electrocardiograms, using time (logarithm of root-mean-square of successive differences; LnRMSSD) and frequency domain (logarithm of high-frequency; LnHF) measures', 'cardiac autonomic measures and breathing symptoms', 'Heart-rate (HR) variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424805', 'cui_str': 'Breath symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0562482,"Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
","[{'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Benjamin', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Moran', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Plews', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Kilding', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Barnett', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Verhoeff', 'Affiliation': 'Sport, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Bacon', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand; School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. Electronic address: c.bacon@auckland.ac.nz.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.014']
1900,32826003,The immediate effect of whole body vibration training on the electromyographic activity of contralateral hand muscles; a randomized controlled trial.,"Whole Body Vibration (WBV) has been used as a useful adjunct to improve the neuromuscular function of the upper limb. Cross-transfer of strength plays an important role in rehabilitation of unilateral injuries. The present research intended to evaluate the acute effect of low frequency WBV training on cross-transfer of electromyographic activity and hand muscles strength when the measurement was performed on the contralateral limb. This was a randomized crossover trial conducted in a clinical biomechanics laboratory. Twenty-eight healthy participants aging between 20 and 35 years were included who were involved in two sessions with two weeks of rest. The participants were randomly assigned in two groups as follows: 1) active WBV/sham WBV; 2) sham WBV/active WBV. The participants were asked to stand on the vibrating plate and pull its belt in a vibrating mode using their dominant hand. Then, after a two-week rest, they performed the same task in the vibrating mode (35 Hz). Grip strength and electromyography (root mean square) in flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), extensor carpi radialis (ECR), and extensor carpi ulnaris (ECU) muscles of the contralateral limb were measured before and after exercise in both phases. No significant change was observed in the electrical activity of FDP, FDS, ECR, ECU muscles, and hands' grip strength of the contralateral limb (P > 0.05). WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb. Further studies would help to explore these results for several sessions of WBV on cross-transfer of training.",2020,WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb.,['Twenty-eight healthy participants aging between 20 and 35 years were included who were involved in two sessions with two weeks of rest'],"['low frequency WBV training', 'active WBV/sham WBV; 2) sham WBV/active WBV', 'whole body vibration training', 'Whole Body Vibration (WBV']","['electromyographic activity of contralateral hand muscles', 'Grip strength and electromyography (root mean square) in flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), extensor carpi radialis (ECR), and extensor carpi ulnaris (ECU) muscles of the contralateral limb', ""electrical activity of FDP, FDS, ECR, ECU muscles, and hands' grip strength of the contralateral limb"", 'electromyographic activity and hand muscles strength']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0581668', 'cui_str': 'Muscle structure of hand'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0224261', 'cui_str': 'Structure of flexor digitorum profundus muscle of hand'}, {'cui': 'C0224258', 'cui_str': 'Structure of flexor digitorum superficialis muscle of hand'}, {'cui': 'C0224272', 'cui_str': 'Extensor carpi ulnaris muscle structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0060663', 'cui_str': 'formycin diphosphate'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",28.0,0.0166128,WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb.,"[{'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Taghizadeh Delkhoush', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: Rasool.Bagheri@Semums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Mashhadi Hashemi', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Fatemy', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rozita', 'Initials': 'R', 'LastName': 'Hedayati', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.027']
1901,32826008,"Effect of adding stretching to standardized procedures on cervical range of motion, pain, and disability in patients with non-specific mechanical neck pain: A randomized clinical trial.","OBJECTIVE


to investigate the benefit of adding stretching exercises to cervical joint mobilization and active rotation exercises for patients with non-specific mechanical neck pain.
METHODS


Thirty-eight subjects with non-specific mechanical neck pain were randomly assigned to a standard procedure group (passive cervical mobilization and active cervical rotation range of motion exercise) or a combined procedure (passive cervical mobilization, active cervical rotation range of motion exercises, and stretching procedures). Mixed factorial analysis of variance was used to compare changes between groups over time in active cervical range of motion, Numeric Pain Rating Scale, Neck Disability Index, Global Rating of Change, and Pressure Pain Threshold.
RESULTS


There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001). There was a significant group by time interaction in mean active range of motion during extension (p = 0.01), right rotation (p = 0.004), right and left lateral flexion (p = 0.05, and p = 0.02 respectively). However, there was no significant group by time interaction in mean active range of motion during flexion, left rotation, pain intensity (p = 0.09), right and left pressure pain threshold (p = 0.30, 0.47, respectively), and disability (p = 0.07).
CONCLUSIONS


Both study groups improved significantly in all subjective and objective outcome measures. However, data from this study suggest that adding stretching to the standard procedures may be more effective than the standard procedure alone at improving cervical extension, right rotation, and lateral flexion active range of motion, but not pain and disability.",2020,"There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001).","['Thirty-eight subjects with non-specific mechanical neck pain', 'patients with non-specific mechanical neck pain']","['stretching exercises to cervical joint mobilization and active rotation exercises', 'adding stretching to standardized procedures', 'standard procedure group (passive cervical mobilization and active cervical rotation range of motion exercise) or a combined procedure (passive cervical mobilization, active cervical rotation range of motion exercises, and stretching procedures']","['time interaction in mean active range of motion during extension', 'right and left pressure pain threshold', 'disability', 'right rotation', 'active cervical range of motion, Numeric Pain Rating Scale, Neck Disability Index, Global Rating of Change, and Pressure Pain Threshold', 'time interaction in mean active range of motion during flexion, left rotation, pain intensity', 'mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time', 'cervical range of motion, pain, and disability', 'cervical extension, right rotation, and lateral flexion active range of motion', 'right and left lateral flexion']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}]",38.0,0.127046,"There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001).","[{'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alfawaz', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Department of Physical Therapy, College of Medical Rehabilitation Sciences, King Abdulaziz University, Saudi Arabia.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Lohman', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Alameri', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Brockton Physical Therapy, Riverside, CA, USA.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Daher', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Jaber', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Department of Physical Therapy, School of Rehabilitative Sciences, University of St. Augustine for Health Sciences, Austin, TX, USA. Electronic address: Hjaber@llu.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.020']
1902,32826010,Short-term effect of muscle energy technique and mechanical diagnosis and therapy in sacroiliac joint dysfunction: A pilot randomized clinical trial.,"INTRODUCTION


Sacroiliac joint dysfunction (SIJD) is a prominent source of pain in low back pain (LBP) patients. Tenderness inferior to the posterior superior iliac spine (PSIS) is an important sign presented in SIJD. Techniques including muscle energy technique (MET) and mechanical diagnosis and therapy (MDT) have shown benefits in SIJD. However, the effects of these treatments on tenderness and pain around the PSIS are yet to be determined.
AIM


Compare and examine the preliminary short-term effect of MET and MDT on tenderness and pain around the PSIS in SIJD.
METHODS


Twenty patients, aged between 20 and 65 years and diagnosed with unilateral, sub-acute, or chronic SIJD, were screened for the inclusion criteria and were randomly allocated to the MET or the MDT group. Both the groups received treatment for four sessions over one week. Pain pressure threshold (PPT) and visual analogue scale (VAS) were determined by a blinded assessor on pre- and post-treatment basis.
RESULTS


Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups. No drop-outs and no adverse events were reported.
CONCLUSION


The findings of the study suggest that both interventions may be equally effective in reducing symptoms around the PSIS. However, due to the small sample size, the results need to be interpreted cautiously. Future studies on larger sample size and long-term follow up are warranted.",2020,"Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups.","['Twenty patients, aged between 20 and 65 years and diagnosed with unilateral, sub-acute, or chronic SIJD, were screened for the inclusion criteria', 'low back pain (LBP) patients', 'sacroiliac joint dysfunction']","['MET and MDT', 'muscle energy technique (MET) and mechanical diagnosis and therapy (MDT', 'muscle energy technique and mechanical diagnosis and therapy', 'posterior superior iliac spine (PSIS']","['tenderness and pain', 'drop-outs and no adverse events', 'Pain pressure threshold (PPT) and visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0223646', 'cui_str': 'Structure of posterior superior iliac spine'}]","[{'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0363968,"Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups.","[{'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India. Electronic address: saumyasri2000@nitte.edu.in.'}, {'ForeName': 'Dhanesh', 'Initials': 'D', 'LastName': 'Kumar K U', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India.'}, {'ForeName': 'Harramb', 'Initials': 'H', 'LastName': 'Mittal', 'Affiliation': 'Department of Trauma and Orthopedics, Kanachur Institute of Medical Sciences, Mangalore, Karnataka, India. Electronic address: dr_harramb@yahoo.co.in.'}, {'ForeName': 'Snehil', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Department of Medical Rehabilitation Sciences, King Khalid University, Saudi Arabia.'}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.017']
1903,32826011,"The immediate effect of lumbopelvic manipulation on knee pain, knee position sense, and balance in patients with patellofemoral pain: A randomized controlled trial.","BACKGROUND


Patellofemoral pain (PFP) is a common musculoskeletal disorder. Quadriceps and core muscle neuromuscular control impairments are frequently associated with PFP. Lumbopelvic manipulation (LPM) has been shown to improve quadriceps and core muscle activation and decrease their inhibition, but changes in balance and knee joint position sense (JPS) after this intervention remain unknown.
OBJECTIVE


To determine whether LPM decreases knee pain and JPS error and increases balance performance in patients with PFP.
DESIGN


Randomized controlled trial.
SETTING


Biomechanics laboratory at a rehabilitation science research center.
METHODS


Forty-four patients with PFP participated in this study that randomly divided into two equal groups. One group received LPM and the other received sham LPM (positioning with no thrust) in a single session. At baseline and immediately after the intervention, the outcomes of pain using a visual analog scale, balance using the modified star excursion balance test (mSEBT), and JPS at 20° and 60° of knee flexion using a Biodex dynamometer.
RESULTS


There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention. In addition, we observed significant differences between groups in pain, balance control (anterior direction) and JPS at 60° of knee flexion immediately after the intervention.
CONCLUSION


A single session of LPM immediately improved balance control, knee JPS, and pain in patients diagnosed with PFP.
CLINICAL REHABILITATION IMPACT


Findings suggest that LPM may be used as a therapeutic tool for immediate improvement of symptoms of PFP. However, more research is needed to determine long term results.",2020,"There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention.","['patients with patellofemoral pain', 'patients diagnosed with PFP', 'patients with PFP', 'Biomechanics laboratory at a rehabilitation science research center', 'Forty-four patients with PFP participated']","['Lumbopelvic manipulation (LPM', 'LPM', 'sham LPM', 'lumbopelvic manipulation']","['knee pain, knee position sense, and balance', 'balance performance', 'pain, balance control (anterior direction) and JPS', 'pain using a visual analog scale, balance using the modified star excursion balance test (mSEBT), and JPS at 20° and 60° of knee flexion using a Biodex dynamometer', 'balance control, knee JPS, and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]",44.0,0.0687298,"There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motealleh', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Abbasi', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: leabbasi@sums.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.01.006']
1904,32826014,The effect of Kinesio-tape® on pain and vertical jump performance in active individuals with patellar tendinopathy.,"BACKGROUND


Patellar tendinopathy is a common inflammatory condition in athletes who undergo large volumes of running and jumping. Kinesio-tape® (KT) is proposed to provide pain relief; however, its effect has not been examined on patellar tendinopathy.
OBJECTIVE


To examine the effects of KT on pain modulation for active individuals with patellar tendinopathy during functional activities.
METHODS


Thirteen symptomatic knees from seven college-aged females (6 bilateral; 1 unilateral) were included. Participants underwent three data collection sessions with KT, sham, and no tape (NT) in a randomized order. During the session, participants performed a maximum vertical jump, single-leg squats and isometric knee extension. The KT intervention was applied according to the KT manual and the sham utilized the same pattern without tension. Pain level was evaluated using the numeric pain scale before, during and after each activity. Function was assessed as maximum vertical jump height and maximum isometric strength. A separate repeated measures ANOVA was used to compare each dependent variable (pain level, vertical jump height, and isometric strength) among the conditions.
RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22). Significantly lower jump heights were found under KT (17.73 ± 3.06in) during the maximum vertical jump test compared to sham (18.65 ± 2.17in, p = 0.000) and NT (18.18 ± 2.93in, p = 0.008).
CONCLUSIONS


The use of the KT tape with a tendon corrective strip and muscle facilitative strip was effective for decreasing pain associated with patellar tendinopathy during jump landing but led to decreased maximum jump height.
CLINICAL TRIAL IDENTIFIER


NCT04153877.",2020,"RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22).","['athletes who undergo large volumes of running and jumping', 'Thirteen symptomatic knees from seven college-aged females (6 bilateral; 1 unilateral) were included', 'active individuals with patellar tendinopathy', 'active individuals with patellar tendinopathy during functional activities']","['KT', 'Kinesio-tape®', 'KT tape with a tendon corrective strip and muscle facilitative strip', 'KT, sham, and no tape (NT', 'KT intervention', 'Kinesio-tape® (KT']","['pain scores', 'pain modulation', 'variable (pain level, vertical jump height, and isometric strength', 'pain and vertical jump performance', 'numeric pain scale', 'maximum vertical jump height and maximum isometric strength', 'Pain level', 'jump heights']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",13.0,0.0538643,"RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22).","[{'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: ktamura@hawaii.edu.'}, {'ForeName': 'Portia B', 'Initials': 'PB', 'LastName': 'Resnick', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, 1250 Bellflower Boulevard, Long Beach, CA, 90804, USA. Electronic address: portia.resnick@csulb.edu.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Hamelin', 'Affiliation': 'Department of Athletics, Florida Atlantic University, 777 Glades Rd, Boca Raton, FL, 33431, USA. Electronic address: bhamelin@fau.edu.'}, {'ForeName': 'Yukiya', 'Initials': 'Y', 'LastName': 'Oba', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: yukiya@hawaii.edu.'}, {'ForeName': 'Ronald K', 'Initials': 'RK', 'LastName': 'Hetzler', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: hetzler@hawaii.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Stickley', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: cstickle@hawaii.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.005']
1905,32826015,The immediate effect of IASTM vs. Vibration vs. Light Hand Massage on knee angle repositioning accuracy and hamstrings flexibility: A pilot study.,"INTRODUCTION


The effectiveness of novel soft-tissue interventions relative to traditional ones requires further exploration. The purpose of this pilot study was to evaluate the immediate effect of Instrument Assisted Soft Tissue Mobilization (IASTM) compared to Vibration Massage or Light Hand Massage on hamstrings' flexibility and knee proprioception.
METHODS


16 healthy non-injured male participants (mean age 23.7 years, height 1.80 cms and body mass 77.7 kg) were randomly assigned to the following interventions: (a) 5min IASTM, (b) 5min Vibration Massage and (c) 8min Light Hand-Massage, sequentially delivered to all participants with an in-between 1-week time interval. A single application of each intervention was given over the hamstrings of their dominant leg (repeated measures under 3 different experimental conditions). An active knee angle reproduction proprioception test and the back-saver sit and reach flexibility test were performed before and immediately after each intervention. Reliability of outcomes was also assessed.
RESULTS


Reliability for flexibility (ICC 3,1  = 0.97-0.99/SEM = 0.83-1.52 cm) and proprioception (ICC 3,1  = 0.83-0.88/SEM = 1.63-2.02°) was very good. For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences. For proprioception, improvement in the IASTM (2.12°), Vibration Massage (0.32°) and Light Hand-Massage (1.17°) conditions was not statistically significant; no between-group differences were also evident.
CONCLUSIONS


Our findings indicate that muscle flexibility was positively influenced immediately after a single intervention of IASTM, Vibration Massage or Light Hand Massage. Proprioception changes were not statistically significant either within or between groups. Further evaluation of those interventions in a larger population with hamstrings pathology is required.",2020,"For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences.","['16 healthy non-injured male participants ', 'mean age 23.7 years, height 1.80\xa0cms and body mass 77.7\xa0kg']","['Instrument Assisted Soft Tissue Mobilization (IASTM', 'novel soft-tissue interventions', 'IASTM vs. Vibration vs. Light Hand Massage', 'Vibration Massage or Light Hand Massage', '5min IASTM, (b) 5min Vibration Massage and (c) 8min Light Hand-Massage']","['knee angle repositioning accuracy and hamstrings flexibility', 'Proprioception changes', 'Vibration Massage', 'muscle flexibility']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0041718', 'cui_str': 'Centers for Medicare and Medicaid Services'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",16.0,0.0143657,"For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Koumantakis', 'Affiliation': '401 General Army Hospital of Athens, Physiotherapy Department, Pan. Kanellopoulou 1, Athens, Greece; Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK. Electronic address: g.koumantakis2@gmail.com.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Roussou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Georgios A', 'Initials': 'GA', 'LastName': 'Angoules', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Nikolaos A', 'Initials': 'NA', 'LastName': 'Angoules', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Alexandropoulos', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Mavrokosta', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Prokopios', 'Initials': 'P', 'LastName': 'Nikolaou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Filippi', 'Initials': 'F', 'LastName': 'Karathanassi', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papadopoulou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.007']
1906,32826624,"Double standards: why is pulse oximetry standard care, whereas tissue oximetry is not?","PURPOSE OF REVIEW


Why is pulse oximetry a standard monitor, whereas tissue oximeter is not? Is this a double-standard treatment?
RECENT FINDINGS


There appears to be a lack of enthusiasm for a continual investigation into whether the use of pulse oximetry leads to reduced morbidity and mortality in acute care although there is no robust evidence attesting to its outcome benefits. In contrast, research investigating the outcome effectiveness of tissue oximetry-guided care is consistently ongoing. A recent randomized controlled trial involving 800 patients who underwent laparoscopic hysterectomy found that, although muscular tissue oxygen saturation-guided care did not reduce the overall occurrence of postoperative nausea and vomiting for all patients, it did reduce the occurrence of these symptoms in patients who had a body mass index ≥25. It was also observed that muscular tissue oxygen saturation increases when blood pressure falls following the administration of nicardipine. These studies highlight the persistence of interest in understanding the value of tissue oximetry in patient care.
SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits. This difference may root in the difference in the physiology they monitor, the cost, the ease of use/interpretation/intervention and the relevance to patient safety and care quality. Pulse oxygen saturation represents a vital sign, whereas tissue oxygen saturation is likely a quality sign; however, further research endeavors are required to fully understand how to best use tissue oximetry.",2020,"SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits.","['800 patients who underwent', 'patients who had a body mass index ≥25']","['laparoscopic hysterectomy', 'tissue oximetry-guided care', 'muscular tissue oxygen saturation-guided care', 'nicardipine']","['blood pressure falls', 'overall occurrence of postoperative nausea and vomiting']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0439779', 'cui_str': 'BP fall'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",800.0,0.0313832,"SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits.","[{'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Jiangxi Cancer Hospital.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Lingzhong', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Current opinion in anaesthesiology,['10.1097/ACO.0000000000000910']
1907,32826717,"Intervention and Mechanisms of Alanyl-glutamine for Inflammation, Nutrition, and Enteropathy: A Randomized Controlled Trial.","OBJECTIVE


Determine the minimum dosage of alanyl-glutamine (Ala-Gln) required to improve gut integrity and growth in children at risk of environmental enteropathy (EE).
METHODS


This was a double-blinded randomized placebo-controlled dose-response trial. We enrolled 140 children residing in a low-income community in Fortaleza, Brazil. Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1. We randomized children to 10 days of nutritional supplementation: Ala-Gln at 3 g/day, Ala-Gln at 6 g/day, Ala-Gln at 12 g/day, or an isonitrogenous dose of glycine (Gly) placebo at 12.5 g/day. Our primary outcome was urinary lactulose-mannitol excretion testing. Secondary outcomes were anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy).
RESULTS


Of 140 children, 103 completed 120 days of follow-up (24% dropout). In the group receiving the highest dose of Ala-Gln, we detected a modest improvement in urinary lactulose excretion from 0.19% on day 1 to 0.17% on day 10 (P = 0.05). We observed significant but transient improvements in WHZ at day 10 in 2 Ala-Gln groups, and in WHZ and WAZ in all Ala-Gln groups at day 30. We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose Ala-Gln promotes short-term improvement in gut integrity and ponderal growth in children at risk of EE. Lower doses produced improvements in ponderal growth in the absence of enhanced gut integrity.",2020,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","['140 children residing in a low-income community in Fortaleza, Brazil', 'children at risk of EE', 'Of 140 children, 103 completed 120 days of follow-up (24% dropout', 'children at risk of environmental enteropathy (EE', 'Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1', 'participants receiving Ala-Gln.\nCONCLUSIONS\n\n\nIntermediate dose']","['glycine (Gly) placebo', 'nutritional supplementation: Ala-Gln at 3\u200ag/day, Ala-Gln at 6\u200ag/day, Ala-Gln', 'alanyl-glutamine (Ala-Gln', 'placebo']","['anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy', 'gut integrity and ponderal growth', 'fecal energy and fecal lactoferrin', 'Inflammation, Nutrition, and Enteropathy', 'urinary lactulose-mannitol excretion testing', 'urinary lactulose excretion', 'fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",140.0,0.33091,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","[{'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Moore', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Quinn', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Maier', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Guedes', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Josiane S', 'Initials': 'JS', 'LastName': 'Quetz', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Ramprasad', 'Affiliation': 'Department of Internal Medicine, NYU School of Medicine/NYU Langone Medical Center, New York, NY.'}, {'ForeName': 'Gabriela M L', 'Initials': 'GML', 'LastName': 'Lanzarini Lopes', 'Affiliation': 'Department of Emergency Medicine, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mayneris-Perxachs', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, and Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swann', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College, London.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'José Q', 'Initials': 'JQ', 'LastName': 'Filho', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Junior', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Havt', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Noelia L', 'Initials': 'NL', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Disease and International Health, Department of Medicine, Center for Global Health, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Aldo A M', 'Initials': 'AAM', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002834']
1908,32826776,Tailored to Fit: How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings.,"BACKGROUND


Veterans Affairs (VA) has rolled out a holistic, multicomponent Whole Health care model nationwide, yet no pragmatic trials have been conducted in real-world clinical settings to compare its effectiveness against other evidence-based approaches for chronic pain management in veterans.
OBJECTIVES


We describe the adaptation of the first large pragmatic randomized controlled trial of the Whole Health model for chronic pain care for diverse VA clinical settings.
RESEARCH DESIGN


Informed by the Promoting Action on Research Implementation in Health Systems implementation framework, we conducted qualitative semistructured interviews to obtain feedback on trial design from VA leadership, frontline clinicians, and veterans with chronic pain at 5 VA enrollment sites. Next, we convened in-person evidence-based quality improvement (EBQI) meetings with study stakeholders (including frontline clinicians and administrators) at each site to discuss study design; review interview themes; and identify site-specific barriers, facilitators, and approaches to implementation. Ethnographic observations from EBQI meetings provided additional insight into implementation strategies.
SUBJECTS


Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings.
RESULTS


At each site, unique clinical contexts and varying resources for Whole Health and pain care delivery affected plans for trial implementation. We present examples of local adaptations that emerged through the formative evaluation process to facilitate implementation and yield a more pragmatic trial design.
CONCLUSIONS


A systematic formative evaluation can facilitate engagement and buy-in of study stakeholders. Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.",2020,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,['Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings'],[],[],"[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]",[],[],,0.194153,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Purcell', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Becker', 'Affiliation': 'VA Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Kara A', 'Initials': 'KA', 'LastName': 'Zamora', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGrath', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Hildi J', 'Initials': 'HJ', 'LastName': 'Hagedorn', 'Affiliation': 'Minneapolis VA Health Care System.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Fabian', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'McCamish', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Seal', 'Affiliation': 'San Francisco VA Health Care System.'}]",Medical care,['10.1097/MLR.0000000000001376']
1909,32826778,A Brief Report on an 8-Week Course of Mindfulness-based Care for Chronic Pain in the Treatment of Veterans With Back Pain: Barriers Encountered to Treatment Engagement and Lessons Learned.,"BACKGROUND


Chronic pain and associated symptoms are debilitating for veterans. Medical costs of treatments are high and current treatment options, most notably with opioid medications, have been associated with significant risk. Mindfulness-based interventions appear promising for chronic pain, but require additional testing in veteran care settings.
OBJECTIVE


This project was designed to test the feasibility of engaging and retaining veterans with chronic lower back pain in a new mindfulness protocol tailored for veterans, mindfulness-based care for chronic pain (MBCP). Clinical outcomes were also assessed.
DESIGN


An open pilot trial of an 8-week MBCP course that included meditation, gentle yoga, and psychoeducation.
SUBJECTS


Twenty-two veterans (mean age=49.77; 18% women) were recruited from a VA Medical Center in the Northeastern US. After screening for inclusion/exclusion criteria, 20 were eligible at baseline.
MEASURES


Veterans were assessed at baseline and postintervention for functional impairment, pain intensity and bothersomeness, depression, and mindfulness.
RESULTS


The average number of sessions completed was 5; only 4 (20%) attended all sessions. Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits. Five of the 11 had a clinically meaningful decrease in pain intensity and in depressive symptoms, while 6 of 11 had a meaningful decrease in pain bothersomeness and functional impairment.
CONCLUSIONS


It was challenging to enroll and retain participants in this study, even with our intervention designed for veterans. We discuss possible adaptations and refinements in MBCP for veterans with chronic pain to enhance feasibility and improve upon these interventions.",2020,Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits.,"['Twenty-two veterans (mean age=49.77; 18% women) were recruited from a VA Medical Center in the Northeastern US', 'veterans, mindfulness-based care for chronic pain (MBCP', 'Veterans With Back Pain', 'Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits', 'veterans with chronic pain']","['Mindfulness-based Care', 'MBCP course that included meditation, gentle yoga, and psychoeducation']","['pain bothersomeness and functional impairment', 'functional impairment, pain intensity and bothersomeness, depression, and mindfulness', 'pain intensity and in depressive symptoms']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0468803,Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits.,"[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Eaton', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Department of Veteran Affairs Medical Center, Providence VA Medical Center.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'Department of Veteran Affairs Medical Center, Center for Neurorestoration and Neurotechnology.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zand Vakili', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Department of Veteran Affairs Medical Center, Providence VA Medical Center.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Jones', 'Affiliation': 'Department of Veteran Affairs Medical Center, Center for Neurorestoration and Neurotechnology.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Greenberg', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Department of Veteran Affairs Medical Center, Providence VA Medical Center.'}]",Medical care,['10.1097/MLR.0000000000001377']
1910,32826784,Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.,"BACKGROUND


Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP).
OBJECTIVE


Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care.
METHODS


Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon.
RESULTS


Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was ""dominant"" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost.
DISCUSSION/CONCLUSIONS


Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.",2020,Negligible differences in health care costs were found between groups.,"['Veterans', 'military veterans with cLBP', 'Participants (n=150', 'persons with chronic low back pain (cLBP']",[],"['Roland-Morris Disability Questionnaire', 'Health care costs', 'pain and disability', 'EQ-5D scale', 'health care costs', 'Quality-adjusted life years (QALYs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",150.0,0.0429254,Negligible differences in health care costs were found between groups.,"[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Richard', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Tally', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}]",Medical care,['10.1097/MLR.0000000000001356']
1911,32827209,Effect of the Combination of Ketorolac and Bupivacaine on Transversus Abdominis Plane Block for Postoperative Analgesia After Gynecological Laparoscopic Surgery.,"BACKGROUND This study assessed the additional benefits of bupivacaine when combined with ketorolac for transversus abdominis plane (TAP) block after gynecological laparoscopic surgery. MATERIAL AND METHODS This randomized, observer-blind trial recruited 153 patients who underwent gynecological laparoscopic surgery. Patients were randomly assigned to receive bupivacaine combined with ketorolac 15 mg/side for TAP block (TK group), bupivacaine for TAP block and 30 mg postoperative intravenous ketorolac (T group), or 30 mg postoperative intravenous ketorolac alone (C group). The primary endpoints included consumption of sufentanil for 24 h postoperatively, actual press times of the patient-controlled analgesia (PCA) pump, and effective press times of the PCA pump, whereas the secondary endpoints included numerical rating scale (NRS) pain scores at rest and during activity, satisfaction with analgesia, episodes of nausea and vomiting and length of hospital stay. RESULTS Sufentanil consumption, actual press times of the PCA pump, and effective press times of the PCA pump were lower in the TK and T groups than in the C group. NRS scores at rest and during activity at 1, 2, 4, 6, and 24 hours were significantly lower in the TK and T groups than in the C group. The TK and T groups showed greater satisfaction with analgesia than the C group, while the TK group showed greater overall satisfaction than the C group. Lengths of stay, rates of nausea and vomiting, and venting times did not differ significantly among the three groups. CONCLUSIONS Combined ketorolac and bupivacaine as TAP block improved the effectiveness of analgesia without increasing adverse events. Trial registration number: ChiCTR1900022577.",2020,"NRS scores at rest and during activity at 1, 2, 4, 6, and 24 hours were significantly lower in the TK and T groups than in the C group.","['transversus abdominis plane (TAP) block after gynecological laparoscopic surgery', '153 patients who underwent']","['bupivacaine combined with ketorolac 15 mg/side for TAP block (TK group), bupivacaine for TAP block and 30 mg postoperative intravenous ketorolac (T group), or 30 mg postoperative intravenous ketorolac alone', 'gynecological laparoscopic surgery', 'bupivacaine', 'Ketorolac and Bupivacaine', 'Gynecological Laparoscopic Surgery', 'ketorolac']","['overall satisfaction', 'satisfaction with analgesia', 'effective press times of the PCA pump', 'numerical rating scale (NRS) pain scores at rest and during activity, satisfaction with analgesia, episodes of nausea and vomiting and length of hospital stay', 'consumption of sufentanil for 24 h postoperatively, actual press times of the patient-controlled analgesia (PCA) pump, and effective press times of the PCA pump', 'Lengths of stay, rates of nausea and vomiting, and venting times', 'Transversus Abdominis Plane Block for Postoperative Analgesia', 'NRS scores']","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",153.0,0.160045,"NRS scores at rest and during activity at 1, 2, 4, 6, and 24 hours were significantly lower in the TK and T groups than in the C group.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}, {'ForeName': 'Shao-Qiang', 'Initials': 'SQ', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925006']
1912,32827348,"Double-Blind, Placebo-Controlled Study of Lurasidone Monotherapy for the Treatment of Bipolar I Depression.","AIM


Previous studies conducted primarily in the US and Europe have demonstrated the efficacy and safety of lurasidone 20-120 mg/day for the treatment of bipolar I depression. The aim of the current study was to evaluate the efficacy and safety of lurasidone monotherapy for the treatment of bipolar I depression among patients from diverse ethnic backgrounds including those from Japan.
METHODS


Patients were randomly assigned to double-blind treatment with lurasidone, 20-60 mg/day (N = 182) or 80-120 mg/day (N = 169) or placebo (N = 171) for 6 weeks. The primary endpoint was change from baseline to week 6 on the Montgomery Åsberg Depression Rating Scale (MADRS).
RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6). Treatment with lurasidone 20-60 mg/day also improved MADRS response rates, functional impairment, and anxiety symptoms. The most common adverse events associated with lurasidone were akathisia and nausea. Lurasidone treatments were associated with minimal changes in body weight, lipids, and measures of glycemic control.
CONCLUSION


Monotherapy with daily doses of lurasidone 20-60 mg, but not 80-120 mg, significantly reduced depressive symptoms and improved functioning in patients with bipolar I depression. Results were overall consistent with previous studies, suggesting that lurasidone 20-60 mg/day is effective and safe in diverse ethnic populations including Japanese. This article is protected by copyright. All rights reserved.",2020,"RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","['patients with bipolar I depression', 'bipolar I depression among patients from diverse ethnic backgrounds including those from Japan', 'Patients']","['lurasidone', 'Placebo', 'Monotherapy', 'lurasidone monotherapy', 'Lurasidone Monotherapy', 'placebo']","['Montgomery Åsberg Depression Rating Scale (MADRS', 'depressive symptoms', 'weight or metabolic parameters', 'efficacy and safety', 'akathisia and nausea', 'mean MADRS total scores', 'MADRS response rates, functional impairment, and anxiety symptoms', 'body weight, lipids, and measures of glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.15438,"RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","[{'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Laboratory for Molecular Dynamics of Mental Disorders, RIKEN Center for Brain Science, Wako, Saitama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': 'Institute of CNS Pharmacology, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Miyajima', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Watabe', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Fujimori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Masuda', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Japan Depression Center, Tokyo, Japan.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Bipolar and Depressive Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13137']
1913,32822347,Safety and parasite clearance of artemisinin-resistant Plasmodium falciparum infection: A pilot and a randomised volunteer infection study in Australia.,"BACKGROUND


Artemisinin resistance is threatening malaria control. We aimed to develop and test a human model of artemisinin-resistant (ART-R) Plasmodium falciparum to evaluate the efficacy of drugs against ART-R malaria.
METHODS AND FINDINGS


We conducted 2 sequential phase 1, single-centre, open-label clinical trials at Q-Pharm, Brisbane, Australia, using the induced blood-stage malaria (IBSM) model, whereby healthy participants are intravenously inoculated with blood-stage parasites. In a pilot study, participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites. In a comparative study, participants were randomised to receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1). In both studies, participants were administered a single approximately 2 mg/kg oral dose of artesunate (AS; Day 9). Primary outcomes were safety, ART-R parasite infectivity, and parasite clearance. In the pilot study, 2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years]). In the comparative study, 25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years]). In both studies, all participants inoculated with ART-R parasites became parasitaemic. A total of 36 adverse events were reported in the pilot study and 277 in the comparative study. Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious. Seven participants experienced transient severe falls in white cell counts and/or elevations in liver transaminase levels which were considered related to malaria. Additionally, 2 participants developed ventricular extrasystoles that were attributed to unmasking of a predisposition to benign fever-induced tachyarrhythmia. In the comparative study, parasite clearance half-life after AS was significantly longer for ART-R infected participants (n = 13, 6.5 hours; 95% confidence interval [CI] 6.3-6.7 hours) compared with ART-S infected participants (n = 9, 3.2 hours; 95% CI 3.0-3.3 hours; p < 0.001). The main limitation of this study was that the ART-R and ART-S parasite strains did not share the same genetic background.
CONCLUSIONS


We developed the first (to our knowledge) human model of ART-R malaria. The delayed clearance profile of ART-R parasites after AS aligns with field study observations. Although based on a relatively small sample size, results indicate that this model can be safely used to assess new drugs against ART-R P. falciparum.
TRIAL REGISTRATION


The studies were registered with the Australian New Zealand Clinical Trials Registry: ACTRN12617000244303 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372357) and ACTRN12617001394336 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373637).",2020,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","['healthy participants are intravenously inoculated with blood-stage parasites', '25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years', 'participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites', 'volunteer infection study in Australia', '2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years']","['receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1', 'artemisinin-resistant Plasmodium falciparum infection']","['ventricular extrasystoles', 'delayed clearance profile of ART-R parasites', 'headache, pyrexia, myalgia, nausea, and chills', 'safety, ART-R parasite infectivity, and parasite clearance', 'liver transaminase levels', 'transient severe falls']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}]","[{'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030657', 'cui_str': 'pathogenicity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",2.0,0.271382,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Watts', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Odedra', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marquart', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Azrin N', 'Initials': 'AN', 'LastName': 'Abd-Rahman', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cascales', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Zuleima', 'Initials': 'Z', 'LastName': 'Pava', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cielo', 'Initials': 'C', 'LastName': 'Pasay', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Peatey', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Jörg J', 'Initials': 'JJ', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McCarthy', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003203']
1914,32822361,The effects of whole-body electromyostimulation (WB-EMS) in comparison to a multimodal treatment concept in patients with non-specific chronic back pain-A prospective clinical intervention study.,"BACKGROUND


According to present guidelines, active exercise is one key component in the comprehensive treatment of nonspecific chronic back pain (NSCBP). Whole body electromyostimulation (WB-EMS) is a safe, and time-effective training method, that may be effective in NSCBP-patients.
METHODS


In this prospective and controlled nonrandomized clinical study, two therapeutic approaches were compared. One group received 20 minutes WB-EMS per week. An active control group (ACG) received a multimodal therapy program. A third group included subjects without back pain. To all groups, the following measurement instruments were applied: Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability. In the EMS-group: T0: baseline; T1: at 6 weeks; T2: at 12 weeks and T3: at 24 weeks. In the ACG: T0 baseline and T1 after 4 weeks.
RESULTS


In the intervention group, 128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG. 34 subjects were allocated to the passive control group. The average age was 58.6 years (18-86 years). In the EMS group, the NRS (1-10) improved statistically and clinically significantly by 2 points. The ODI was reduced by 19.7 points. The NASS and most of the SF 36 items improved significantly. In the multimodal treatment group, only the muscular function improved slightly.
CONCLUSION


Our data support the hypothesis that WB-EMS is at least as effective as a multimodal treatment, which is often referred to as being the golden standard. Therefore WB-EMS may be an effective and, with 20 min./week training time, very time-efficient alternative to established multimodal treatment models.",2020,The NASS and most of the SF 36 items improved significantly.,"['The average age was 58.6 years (18-86 years', 'patients with non-specific chronic back pain', '128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG', '34 subjects']","['Whole body electromyostimulation (WB-EMS', 'whole-body electromyostimulation (WB-EMS', 'multimodal therapy program']","['muscular function improved slightly', 'subjects without back pain', 'ODI', 'Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",128.0,0.022024,The NASS and most of the SF 36 items improved significantly.,"[{'ForeName': 'Karl Lorenz', 'Initials': 'KL', 'LastName': 'Konrad', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Baeyens', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Birkenmaier', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Anna Helena', 'Initials': 'AH', 'LastName': 'Ranker', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Widmann', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Leukert', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wenisch', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Kraft', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Jansson', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wegener', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}]",PloS one,['10.1371/journal.pone.0236780']
1915,32822362,"Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali.","BACKGROUND


Seasonal malaria chemoprevention (SMC) is now widely deployed in the Sahel, including several countries that are major contributors to the global burden of malaria. Consequently, it is important to understand whether SMC continues to provide a high level of protection and how SMC might be improved. SMC was evaluated using data from a large, household-randomised trial in Houndé, Burkina Faso and Bougouni, Mali.
METHODS AND FINDINGS


The parent trial evaluated monthly SMC plus either azithromycin (AZ) or placebo, administered as directly observed therapy 4 times per year between August and November (2014-2016). In July 2014, 19,578 children aged 3-59 months were randomised by household to study group. Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016. These analyses focus on the approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group. Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August. The incidence rate ratio comparing SMC within the past 28 days with SMC more than 35 days ago-adjusted for age, country, and household clustering-was 0.13 (95% CI: 0.08, 0.20), P < 0.001 for malaria hospitalisations and deaths from malaria and 0.21 (95% CI 0.20, 0.23), P < 0.001 for uncomplicated malaria, indicating protective efficacy of 87.4% (95% CI: 79.6%, 92.2%) and 78.3% (95% CI: 76.8%, 79.6%), respectively. The prevalence of malaria parasitaemia at weekly surveys during the rainy season and at the end of the transmission season was several times higher in children who missed the SMC course preceding the survey contact, and the smallest prevalence ratio observed was 2.98 (95% CI: 1.95, 4.54), P < 0.001. The frequency of molecular markers of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance did not increase markedly over the study period either amongst study children or amongst school-age children resident in the study areas. After 3 years of SMC deployment, the day 28 PCR-unadjusted adequate clinical and parasitological response rate of the SP + AQ regimen in children with asymptomatic malaria was 98.3% (95% CI: 88.6%, 99.8%) in Burkina Faso and 96.1% (95% CI: 91.5%, 98.2%) in Mali. Key limitations of this study are the potential overdiagnosis of uncomplicated malaria by rapid diagnostic tests and the potential for residual confounding from factors related to adherence to the monthly SMC schedule.
CONCLUSION


Despite strong evidence that SMC is providing a high level of protection, the burden of malaria remains substantial in the 2 study areas. These results emphasise the need for continuing support of SMC programmes. A fifth monthly SMC course is needed to adequately cover the whole transmission season in the study areas and in settings with similar epidemiology.
TRIAL REGISTRATION


The AZ-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT02211729.",2020,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","['In July 2014, 19,578 children aged 3-59 months', 'Houndé District, Burkina Faso and Bougouni District, Mali', 'approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group', 'Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016', 'study children or amongst school-age children resident in the study areas']","['seasonal malaria chemoprevention', 'azithromycin (AZ) or placebo', 'sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance', 'SP + AQ', 'placebo']","['prevalence of malaria parasitaemia', 'parasitological response rate', 'incidence rate ratio comparing SMC', 'smallest prevalence ratio', 'protective efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",19578.0,0.276926,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Cairns', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Serge R', 'Initials': 'SR', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Milligan', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}]",PLoS medicine,['10.1371/journal.pmed.1003214']
1916,32822417,Correction: Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial.,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,['primary care patients with obesity and depression'],[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",[],[],,0.0271133,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': ''}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': ''}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': ''}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': ''}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': ''}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Lenard I', 'Initials': 'LI', 'LastName': 'Lesser', 'Affiliation': ''}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Kristen M J', 'Initials': 'KMJ', 'LastName': 'Azar', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238276']
1917,32822600,"Efficacy and safety of once-daily nitisinone for patients with alkaptonuria (SONIA 2): an international, multicentre, open-label, randomised controlled trial.","BACKGROUND


Alkaptonuria is a rare, genetic, multisystem disease characterised by the accumulation of homogentisic acid (HGA). No HGA-lowering therapy has been approved to date. The aim of SONIA 2 was to investigate the efficacy and safety of once-daily nitisinone for reducing HGA excretion in patients with alkaptonuria and to evaluate whether nitisinone has a clinical benefit.
METHODS


SONIA 2 was a 4-year, open-label, evaluator-blind, randomised, no treatment controlled, parallel-group study done at three sites in the UK, France, and Slovakia. Patients aged 25 years or older with confirmed alkaptonuria and any clinical disease manifestations were randomly assigned (1:1) to receive either oral nitisinone 10 mg daily or no treatment. Patients could not be masked to treatment due to colour changes in the urine, but the study was evaluator-blinded as far as possible. The primary endpoint was daily urinary HGA excretion (u-HGA 24 ) after 12 months. Clinical evaluation Alkaptonuria Severity Score Index (cAKUSSI) score was assessed at 12, 24, 36, and 48 months. Efficacy variables were analysed in all randomly assigned patients with a valid u-HGA 24  measurement at baseline. Safety variables were analysed in all randomly assigned patients. The study was registered at ClinicalTrials.gov (NCT01916382).
FINDINGS


Between May 7, 2014, and Feb 16, 2015, 139 patients were screened, of whom 138 were included in the study, with 69 patients randomly assigned to each group. 55 patients in the nitisinone group and 53 in the control group completed the study. u-HGA 24  at 12 months was significantly decreased by 99·7% in the nitisinone group compared with the control group (adjusted geometric mean ratio of nitisinone/control 0·003 [95% CI 0·003 to 0·004], p<0·0001). At 48 months, the increase in cAKUSSI score from baseline was significantly lower in the nitisinone group compared with the control group (adjusted mean difference -8·6 points [-16·0 to -1·2], p=0·023). 400 adverse events occurred in 59 (86%) patients in the nitisinone group and 284 events occurred in 57 (83%) patients in the control group. No treatment-related deaths occurred.
INTERPRETATION


Nitisinone 10 mg daily was well tolerated and effective in reducing urinary excretion of HGA. Nitisinone decreased ochronosis and improved clinical signs, indicating a slower disease progression.
FUNDING


European Commission Seventh Framework Programme.",2020,u-HGA 24  at 12 months was significantly decreased by 99·7% in the nitisinone group compared with the control group (adjusted geometric mean ratio of nitisinone/control 0·003,"['Patients aged 25 years or older with confirmed alkaptonuria and any clinical disease manifestations', 'patients with alkaptonuria', 'Between May 7, 2014, and Feb 16, 2015, 139 patients were screened, of whom 138 were included in the study, with 69 patients randomly assigned to each group', 'patients with alkaptonuria (SONIA 2', '55 patients in the nitisinone group and 53 in the control group completed the study']","['oral nitisinone 10 mg daily or no treatment', 'once-daily nitisinone']","['cAKUSSI score', 'Clinical evaluation Alkaptonuria Severity Score Index (cAKUSSI) score', 'HGA excretion', 'Efficacy and safety', 'daily urinary HGA excretion', 'efficacy and safety', '400 adverse events', 'urinary excretion of HGA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002066', 'cui_str': 'Alkaptonuria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0173083', 'cui_str': 'nitisinone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1171018', 'cui_str': 'nitisinone 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0173083', 'cui_str': 'nitisinone'}]","[{'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0002066', 'cui_str': 'Alkaptonuria'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019881', 'cui_str': 'Homogentisic acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",139.0,0.228309,u-HGA 24  at 12 months was significantly decreased by 99·7% in the nitisinone group compared with the control group (adjusted geometric mean ratio of nitisinone/control 0·003,"[{'ForeName': 'Lakshminarayan R', 'Initials': 'LR', 'LastName': 'Ranganath', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK. Electronic address: lrang@liv.ac.uk.'}, {'ForeName': 'Eftychia Eirini', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Arnoux', 'Affiliation': 'Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Braconi', 'Affiliation': 'Department of Biotechnology, Chemistry and Pharmacy, University of Siena, Siena, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Briggs', 'Affiliation': 'Department of Ophthalmology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bröijersén', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Loftus', 'Affiliation': 'Department of Physiotherapy, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bygott', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Trevor F', 'Initials': 'TF', 'LastName': 'Cox', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Davison', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Dillon', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Cardiology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'FitzGerald', 'Affiliation': 'Department of Clinical Pharmacology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Genovese', 'Affiliation': 'Nordic Bioscience, Herlev, Denmark.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Glasova', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia; Institute of Pharmacology and Clinical Pharmacology, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Hall', 'Affiliation': 'Cudos, Hoofddorp, Netherlands.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hughes', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Juliette H', 'Initials': 'JH', 'LastName': 'Hughes', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Imrich', 'Affiliation': ""Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia; National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Jarvis', 'Affiliation': 'School of Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Khedr', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Dinny', 'Initials': 'D', 'LastName': 'Laan', 'Affiliation': 'PSR Group, Hoofddorp, Netherlands.'}, {'ForeName': 'Kim-Hanh', 'Initials': 'KH', 'LastName': 'Le Quan Sang', 'Affiliation': 'Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Luangrath', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': ""Ol'ga"", 'Initials': 'O', 'LastName': 'Lukáčová', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Alpesh', 'Initials': 'A', 'LastName': 'Mistry', 'Affiliation': 'Department of Radiology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Mlynáriková', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Norman', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Olsson', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Rhodes', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Rovenský', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Rudebeck', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Santucci', 'Affiliation': 'Department of Biotechnology, Chemistry and Pharmacy, University of Siena, Siena, Italy.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Shweihdi', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Ciarán', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'AKU Society, Cambridge, UK.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Sedláková', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sireau', 'Affiliation': 'AKU Society, Cambridge, UK.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Stančík', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Szamosi', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Department of Physiotherapy, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'van Kan', 'Affiliation': 'PSR Group, Hoofddorp, Netherlands.'}, {'ForeName': 'Sobhan', 'Initials': 'S', 'LastName': 'Vinjamuri', 'Affiliation': 'Department of Nuclear Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Vrtíková', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webb', 'Affiliation': 'Department of Ear, Nose and Throat, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'West', 'Affiliation': 'Department of Dermatology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Záňová', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Zatkova', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Gallagher', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30228-X']
1918,32822633,"Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial.","BACKGROUND


Atogepant is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist under investigation for treatment of migraine. We aimed to examine a range of oral doses for safety, tolerability, and efficacy for the preventive treatment of migraine.
METHODS


In this double-blind, phase 2b/3 trial, adults (aged 18-75 years), with a history (≥1 year) of migraine and 4-14 migraine days per month, were randomly assigned 2:1:2:2:1:1 (by means of a sequence generated by the statistical programming department of the sponsor, and operationalised through an automated interactive web-based response system) to receive placebo or atogepant 10 mg once daily, 30 mg once daily, 60 mg once daily, 30 mg twice daily, or 60 mg twice daily, in matching capsules. Participants, site personnel, and all study sponsor personnel were masked to treatment allocations. The study was done in 78 academic and private practice settings in the USA. The primary outcome was change from baseline in monthly migraine days across 12 weeks of treatment using a modified intention-to-treat approach. The overall type I error rate for multiple comparisons across active treatment doses was controlled at the 0·05 level by means of a graphic approach. The main outcomes to assess safety and tolerability were adverse event recordings. The trial is registered with ClinicalTrials.gov, NCT02848326 and is completed.
FINDINGS


Between Sept 6, 2016, and April 23, 2018, of 1772 individuals screened, 834 were randomly assigned and 825 received one dose or more of study medication: 186 received placebo, 93 atogepant 10 mg once daily, 183 atogepant 30 mg once daily, 186 atogepant 60 mg once daily, 86 atogepant 30 mg twice daily, and 91 atogepant 60 mg twice daily. Overall, 714 (87%) of 825 participants were female, 628 (76%) were white, median migraine duration was 17·5 years (IQR 10·0-28·0), and 232 (28%) had previously used preventive treatment. The primary efficacy analysis included 795 patients: 178 received placebo, 92 atogepant 10 mg once daily, 182 atogepant 30 mg once daily, 177 atogepant 60 mg once daily, 79 atogepant 30 mg twice daily, and 87 atogepant 60 mg twice daily. Across the 12-week treatment period, all five atogepant groups showed significant least-squares mean (SE) change from baseline in mean monthly migraine days versus placebo: atogepant 10 mg once daily -4·0 (0·3; p=0·024), 30 mg once daily -3·8 (0·2; p=0·039), 60 mg once daily -3·6 (0·2; p=0·039), 30 mg twice daily -4·2 (0·4; p=0·0034), and 60 mg twice daily -4·1 (0·3; p=0·0031); placebo -2·9 (0·2). The most common treatment-emergent adverse events (TEAEs) across all groups were nausea (range 5% [5/93] for 10 mg once daily to 12% [22/186] for 60 mg once daily vs 5% [9/186] for placebo) and fatigue (1% [1/93] for 10 mg once daily to 10% [9/91] for 60 mg twice daily vs 3% [6/186] for placebo). Treatment-related TEAE frequency ranged from 18% (17/93) for 10 mg once daily to 26% (24/91) for 60 mg twice daily, versus 16% (30/186) for placebo. Seven participants reported a total of eight serious TEAEs (two participants each in the placebo, 30 mg once-daily, and 60 mg once-daily groups, and one participant in the 10 mg once-daily group). TEAEs leading to discontinuation were reported in 33 (5%) of 639 atogepant participants and 5 (3%) of 186 of those randomised to placebo. All serious TEAEs were unrelated to treatment.
INTERPRETATION


All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo. Atogepant was safe and well tolerated over 12 weeks, supporting its phase 3 development for the preventive treatment of migraine.
FUNDING


Allergan (before its acquisition by AbbVie).",2020,All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo.,"['714 (87%) of 825 participants were female, 628 (76%) were white, median migraine duration was 17·5 years (IQR 10·0-28·0), and 232 (28%) had previously used preventive treatment', 'adults (aged 18-75 years), with a history (≥1 year) of migraine and 4-14 migraine days per month', 'Between Sept 6, 2016, and April 23, 2018, of 1772 individuals screened, 834 were randomly assigned and 825 received one dose or more of study medication: 186 received', 'episodic migraine in adults', '795 patients: 178 received', '78 academic and private practice settings in the USA']",['placebo'],"['Safety, tolerability, and efficacy', 'fatigue', 'least-squares mean (SE) change', 'safety and tolerability', 'safety, tolerability, and efficacy', 'monthly migraine days', 'nausea', 'safe and well tolerated']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",834.0,0.533574,All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK. Electronic address: UKpeter.goadsby@kcl.ac.uk.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'Medstar Georgetown University Hospital, Washington DC, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30234-9']
1919,32822683,Randomized study of antiseptic application technique in healthy volunteers before vascular access insertion (TApAS trial).,"BACKGROUND


In France about 32% of hospitalized patients have a vascular access placement. However, a common complication associated with these is catheter-related bloodstream infection (CRBI) due to the introduction of microorganisms from the skin during catheter insertion. There is no consensus on the best way to clean the skin prior to catheter insertion, which could be a key element of CRBI prevention. The two techniques most commonly used to apply antiseptic to the skin are the concentric circle and back-and-forth techniques, but these have not been compared in clinical trials. Hence, this study conducted this comparison.
METHODS


This single-center, non-comparative, randomized, matched pilot study investigated the levels of cutaneous microorganisms before and after antiseptic application using both techniques in a population of healthy French volunteers. The two application methods were used on each participant's arms at the elbow fold, with randomization for the application side (right or left). Quantification of cutaneous microorganisms was performed in a blinded manner with regard to the technique used.
FINDINGS


From April 8 to July 17, 2019, 132 healthy volunteers participated in the study. For the whole study population, the mean initial colonization level was 2.68 log10 colony forming units (CFU)/mL (SD 0.82) before the back-and-forth technique, and 2.66 log10 CFU/mL (SD 0.85) before the concentric circle technique. The mean differences in number of microorganisms between the initial sample and the final sample were 2.45 log10 CFU/mL (95% CI: 2.29 to 2.61) for the back-and-forth technique and 2.43 log10 CFU/mL (95% CI: 2.27 to 2.59) for the concentric circle technique. The mean difference in reduction in microorganisms between the back-and-forth technique and the concentric circle technique was 0.02 log10 CFU/mL (95% CI: -0.11 to 0.15).
INTERPRETATION


There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 s of drying of the antiseptic. These findings have a significant impact on time required to achieve antiseptic application before catheter insertion because there is yet no argument to justify application for 30 s, because a single concentric circle pass was much faster with similar results. Future studies should investigate the impact of skin application technique on the prevention of infectious risk associated with catheter insertion on admission to health care facilities (conventional, outpatient, or emergency) and throughout the period of stay in a health care facility.",2020,"There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 seconds of drying of the antiseptic.","['healthy French volunteers', 'healthy volunteers before vascular access insertion (TApAS trial', 'Findings From April 8 to July 17, 2019, 132 healthy volunteers participated in the study']","['antiseptic application technique', 'log10 CFU/mL', 'CFU/mL']",['mean initial colonization level'],"[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",132.0,0.0404688,"There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 seconds of drying of the antiseptic.","[{'ForeName': 'Yolène', 'Initials': 'Y', 'LastName': 'Carre', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France. Electronic address: yolene.carre@chu-bordeaux.fr.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Moal', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Germain', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Frison', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Dubreuil', 'Affiliation': 'Université de Bordeaux, Bordeaux Population Health Research Center, Pharmacoépidémiologie, UMR 1219, F-33000 Bordeaux, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chansel', 'Affiliation': 'CHU de Bordeaux, Nursing Training Institute, F-33000 Bordeaux, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Berger', 'Affiliation': 'CHU Bordeaux Care and human sciences research unit, F-33000 Bordeaux France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Boulestreau', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Lasheras-Bauduin', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Rogues', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France; Université de Bordeaux, Bordeaux Population Health Research Center, Pharmacoépidémiologie, UMR 1219, F-33000 Bordeaux, France.'}]",The Journal of infection,['10.1016/j.jinf.2020.08.022']
1920,32822692,Effect of early and late prenatal vitamin D and maternal asthma status on offspring asthma or recurrent wheeze.,"BACKGROUND


Childhood asthma developmental programming is complex. Maternal asthma is a strong risk factor for childhood asthma, while vitamin D (VD) has emerged as a modifiable prenatal exposure.
OBJECTIVE


To examine the combined effect of early and late prenatal VD status in pregnancies with and without asthma on childhood asthma/recurrent wheeze development.
METHODS


We conducted a cohort study using prospectively collected data from the Vitamin D Antenatal Asthma Reduction Trial (VDAART), a randomized, double-blinded, placebo-controlled vitamin D supplementation trial in pregnant women at high risk of offspring asthma (N=806 mother-offspring pairs). 25-hydroxyvitamin-D [25(OH)D] was measured in early and late pregnancy. Our main exposure was an ordered variable representing early and late prenatal VD sufficiency [25(OH)D>30ng/mL)] status in pregnancies with and without asthma. The primary outcome was offspring asthma or recurrent wheeze by age 3 years. We also examined the effect of prenatal VD on early life asthma/recurrent wheeze progression to active asthma at age 6 years.
RESULTS


Among maternal asthmatics, compared to those with early and late prenatal VD insufficiency, those with early or late VD sufficiency (aOR=0.56; 95% CI 0.31-1.00) or early and late VD sufficiency (aOR=0.36; 95% CI 0.15-0.81) had lower risk of offspring asthma/recurrent wheeze by age 3 years (P for trend =0.008). This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
CONCLUSION


This study implicates a protective role for VD sufficiency throughout pregnancy, particularly in attenuating the risk conferred by maternal asthma on childhood asthma/recurrent wheeze development.
CLINICAL IMPLICATION


Early identification and correction of vitamin D insufficiency in asthmatic pregnant women have implications for the prevention of early offspring asthma/recurrent wheeze and the persistence of offspring asthma to later childhood.",2020,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
","['early life asthma/recurrent wheeze progression to active asthma at age 6 years', 'pregnant women at high risk of offspring asthma (N=806 mother-offspring pairs', 'pregnancies with and without asthma on childhood asthma/recurrent wheeze development', 'asthmatic pregnant women', 'offspring asthma or recurrent wheeze', 'pregnancies with and without asthma']","['early and late prenatal vitamin D', 'Vitamin D Antenatal Asthma Reduction Trial (VDAART', 'prenatal VD', 'placebo-controlled vitamin D supplementation']","['25-hydroxyvitamin-D [25(OH)D', 'offspring asthma or recurrent wheeze by age 3 years', 'lower risk of offspring asthma/recurrent wheeze']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",,0.10878,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
","[{'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Golisano Children's Hospital at University of Rochester Medical Center, Rochester, NY, USA.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center, Department of Medicine, Boston Medical Center, Boston University, Boston, MA, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Department of Allergy and Research and Evaluation, Kaiser Permanente Southern California Region, San Diego and Pasadena, CA, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bacharier', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schatz', 'Affiliation': 'Department of Allergy and Research and Evaluation, Kaiser Permanente Southern California Region, San Diego and Pasadena, CA, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: hoomi@post.harvard.edu.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.041']
1921,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis (RA). Eighty RA patients were randomized to tocilizumab (n = 40) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and glucocorticoids (GC) (n = 40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: (a)perfused boundary region (PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), (b)pulse wave velocity (PWV), (c)global LV longitudinal strain (GLS), (d)global work index (GWI) using speckle tracking echocardiography and e)C-reactive protein (CRP), malondialdehyde (MDA) and protein carbonyls (PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers (P < 0.05). Compared with baseline, tocilizumab reduced PBR(2.14 ± 0.2 versus 1.97 ± 0.2 μm; P < 0.05) while no significant differences were observed post-csDMARDs + GC(P > 0.05). Compared with csDMARDs + GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P < 0.05). The percent improvement of glycocalyx thickness (PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P < 0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs + GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: url: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
1922,32822827,A community-based asthma program: Study design and methods of RVA Breathes.,"Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, asthma symptoms, and quality of life. We will enroll 300 elementary school children from the Richmond City Public School system. Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years. Participants will be randomized to one of three groups: asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition. Data will be collected across one baseline research visit, four intervention sessions, and four follow-up research visits over the course of 18 months. A General Linear Mixed Model (GLMM) will be used to test primary aims. We expect the findings will provide support for coordination of asthma care across sectors. Further, we hope RVA Breathes will serve as a model of community-based pediatric asthma care.",2020,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","['Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years', '300 elementary school children from the Richmond City Public School system']","['asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition', 'RVA']","['asthma control, asthma symptoms, and quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",300.0,0.0360733,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","[{'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Everhart', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America. Electronic address: reverhart@vcu.edu.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Holder', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Schechter', 'Affiliation': ""Children's Hospital of Richmond at VCU, Richmond, VA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106121']
1923,32822898,Temporal precedence of the change in obsessive-compulsive symptoms and change in depressive symptoms during exposure and response prevention for pediatric obsessive-compulsive disorders.,"The current study examined the temporal precedence of change in obsessive-compulsive symptoms and change in depressive symptoms during the course of an Exposure and Response Prevention (ERP) for pediatric OCD. Participants included 142 children and adolescents (7-17 years; mean age = 12.39, SD = 2.92; 51.40% female; 60.40% Non-Hispanic White) with a primary or co-primary diagnosis of OCD who received ERP in a two-site randomized controlled trial on d-cycloserine augmentation of CBT for pediatric OCD. Participants completed clinician-administered assessments of OC symptoms (Children's Yale-Brown Obsessive Compulsive Scale) and depressive symptoms (Children's Depression Rating Scale-Revised) from baseline to post-treatment follow-up. Lagged mediational analyses did not yield evidence in support of a mediating role for the change in OC symptoms in the effect of ERP on the change in depressive symptoms. In contrast, change in depressive symptoms mediated the effect of ERP treatment on the subsequent change in OC symptoms (95% confidence interval for indirect effect = -0.04 to -0.001), though the effect size was small. Controlling for the prior levels of the depressive symptoms this indirect effect became non-significant. Theoretical and clinical implications of the findings for the youth with OCD and comorbid depression are discussed.",2020,Lagged mediational analyses did not yield evidence in support of a mediating role for the change in OC symptoms in the effect of ERP on the change in depressive symptoms.,"['Participants included 142 children and adolescents (7-17 years; mean age\xa0=\xa012.39, SD\xa0=\xa02.92; 51.40% female; 60.40% Non-Hispanic White) with a primary or co-primary diagnosis of OCD who received ERP in a two-site randomized controlled trial on d-cycloserine augmentation of CBT for pediatric OCD', 'pediatric obsessive-compulsive disorders']",[],"[""clinician-administered assessments of OC symptoms (Children's Yale-Brown Obsessive Compulsive Scale) and depressive symptoms (Children's Depression Rating Scale-Revised"", 'obsessive-compulsive symptoms and change in depressive symptoms', 'depressive symptoms', 'OC symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",[],"[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",142.0,0.25284,Lagged mediational analyses did not yield evidence in support of a mediating role for the change in OC symptoms in the effect of ERP on the change in depressive symptoms.,"[{'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Bakhshaie', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA. Electronic address: jbakhshaie@mgh.harvard.edu.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Geller', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, USA; Harvard University Medical School, 25 Shattuck St, Boston, MA, 02115, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, USA; Harvard University Medical School, 25 Shattuck St, Boston, MA, 02115, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Johns Hopkins University School of Medicine, 1800 Orleans Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Small', 'Affiliation': 'School of Aging Studies, University of South Florida, 13301 Bruce B Downs Blvd, Tampa, FL, 33620, USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Cepeda', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Schneider', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Murphy', 'Affiliation': ""Department of Pediatrics, University of South Florida, 2 Tampa General Cir, Tampa, FL, 33606, USA; Department of Psychiatry & Behavioral Neurosciences, University of South Florida, 3515 E Fletcher Ave, Tampa, FL, 33613, USA; Johns Hopkins Medicine All Children's Hospital, 501 6th Ave S, St. Petersburg, FL, 33701, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Porth', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103697']
1924,32823200,Opposite effects of smoking and nicotine intake on cognition.,"Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped effect. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the cognitive tasks. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.",2020,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","['heavy smokers and healthy nonsmokers', 'healthy nonsmokers']","['nicotine', 'nicotine gum', 'placebo']",[],"[{'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0106464,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","[{'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: natalialalmeida@hotmail.com.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Letícia M', 'Initials': 'LM', 'LastName': 'Gonçalves', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'University of Rochester Medical Center, Department of Psychiatry, NY, USA.'}, {'ForeName': 'Isadora C', 'Initials': 'IC', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, NY, USA.'}, {'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: paivatm@gmail.com.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.113357']
1925,32823218,Effect of adjunctive single dose parental vitamin D replacement on improving depression ratings in major depression with concurrent vitamin D deficiency: A double-blind randomized placebo-controlled trial.,"Adjunctive vitamin D replacement is a theoretically promising strategy to improve outcomes in major depression. Our objective was to assess the efficacy of a single parenteral dose of vitamin D supplementation at baseline as an adjunct to treatment as usual on change in depression symptom ratings (primary outcome), quality of life and clinical severity of illness (secondary outcomes) at the end of 12 weeks when compared to treatment as usual in patients with major depression and concurrent Vitamin D deficiency. Eligible participants were randomized to receive either treatment as usual (TAU; n = 23) or TAU plus single parenteral dose of 3,00,000 IU of vitamin D (n = 23) at baseline. Rater-blinded assessments of depression (primary outcome), quality of life (QoL) and clinical severity of illness were obtained at baseline, and end of follow-up (12 weeks). Intent-to-treat analyses were performed on the entire randomized sample. The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase. These findings indicate that a single parenteral dose (3,00,000 IU) of adjunctive vitamin D replacement at baseline is an effective and well tolerated intervention in major depressive disorder with concurrent Vitamin D deficiency. Additionally, it points to a possible role for vitamin D in the pathophysiology of depression and supports personalized approaches for treatment of major depressive disorder.",2020,"The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase.","['major depression with concurrent vitamin D deficiency', 'Eligible participants', 'major depressive disorder with concurrent Vitamin D deficiency', 'patients with major depression and concurrent Vitamin D deficiency']","['adjunctive single dose parental vitamin D replacement', 'vitamin D', 'adjunctive vitamin D replacement', 'TAU plus single parenteral dose of 3,00,000 IU of vitamin D', 'Adjunctive vitamin D replacement', 'vitamin D supplementation', 'placebo']","['depression symptom ratings, quality of life and clinical severity of illness', 'quality of life (QoL) and clinical severity of illness', 'depression ratings', 'depression symptom ratings (primary outcome), quality of life and clinical severity of illness (secondary outcomes']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.409899,"The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase.","[{'ForeName': 'Favaz', 'Initials': 'F', 'LastName': 'Vellekkatt', 'Affiliation': 'Department of Psychiatry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: favazvkptaj@gmail.com.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Psychiatry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: drvmenon@gmail.com.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Rajappa', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: linkmedha@gmail.com.'}, {'ForeName': 'Jayaprakash', 'Initials': 'J', 'LastName': 'Sahoo', 'Affiliation': 'Department of Endocrinology, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: jppgi@yahoo.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.037']
1926,32823413,Anti-vascular endothelial growth factor in the treatment of macular edema in epidemic retinitis.,"Purpose


To study efficacy of anti-vascular endothelial growth factor (anti-VEGF) in resolution of macular edema in epidemic retinitis (ER).
Methods


In this retrospective, comparative study, patients diagnosed as ER with central macular thickness (CMT) ≥ 600 μm on SD-OCT at presentation were studied. Eyes which did not receive intravitreal anti-VEGF formed group A and eyes receiving additional anti-VEGF formed group B. Eyes receiving anti-VEGF monotherapy were studied separately. Cases with subsequent OCT scans with interval of more than 20 days and cases without OCT scan at the resolution were excluded. Treatment details, visual outcome, and days to resolution of macular edema were studied.
Results


Mean CMT in group A (n = 8) was 820.1 μm (range 607-1004 μm) and in Group B (n = 4) was 756.0 μm (range 603-1000 μm). Macular edema resolved in 34.8 days (range: 16-65) and 39.0 days (range: 21-45) in group A and B, respectively. Two eyes with anti-VEGF monotherapy recovered in 45 and 18 days, respectively. Mean corrected distance visual acuity (CDVA) at presentation in group A was 19.1 (range: 0-61) ETDRS letters and in group B was 14.3 (range: 0-35) ETDRS letters. Mean CDVA improved to 65.7 (range: 0-85) and 50.8 (range: 20-76) ETDRS letters in group A and B, respectively. Anti-VEGF monotherapy eyes improved from 35 and 46 ETDRS letters to 70 and 85 ETDRS letters, respectively.
Conclusion


Additional anti-VEGF therapy has no added advantage in speed of resolution of macular edema due to ER. A randomized controlled trial with steroids sparing ""anti-VEGF monotherapy"" may verify our observations.",2020,Mean CDVA improved to 65.7 (range: 0-85) and 50.8 (range: 20-76),"['patients diagnosed as ER with central macular thickness (CMT) ≥', 'macular edema in epidemic retinitis (ER', 'macular edema in epidemic retinitis', 'n = 8) was 820.1 μm ']","['intravitreal anti-VEGF formed group A and eyes receiving additional anti-VEGF formed group B. Eyes receiving anti-VEGF monotherapy', 'anti-VEGF monotherapy', 'steroids sparing ""anti-VEGF monotherapy', 'anti-VEGF therapy', 'anti-vascular endothelial growth factor (anti-VEGF', 'Anti-vascular endothelial growth factor']","['Mean CDVA', 'Macular edema', 'Mean corrected distance visual acuity (CDVA', 'visual outcome, and days to resolution of macular edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0035333', 'cui_str': 'Retinitis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0333061,Mean CDVA improved to 65.7 (range: 0-85) and 50.8 (range: 20-76),"[{'ForeName': 'Ankush A', 'Initials': 'AA', 'LastName': 'Kawali', 'Affiliation': 'Department of Uveitis and Ocular Immunology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Retina, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Mehta', 'Affiliation': 'Retina, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Padmamalini', 'Initials': 'P', 'LastName': 'Mahendradas', 'Affiliation': 'Department of Uveitis and Ocular Immunology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Uveitis and Ocular Immunology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Bhujang', 'Initials': 'B', 'LastName': 'Shetty', 'Affiliation': 'General Ophthalmology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_439_20']
1927,32823504,Different Effects of Transcranial Direct Current Stimulation on Leg Muscle Glucose Uptake Asymmetry in Two Women with Multiple Sclerosis.,"Asymmetrical lower limb strength is a significant contributor to impaired walking abilities in people with multiple sclerosis (PwMS). Transcranial direct current stimulation (tDCS) may be an effective technique to enhance cortical excitability and increase neural drive to more-affected lower limbs. A sham-controlled, randomized, cross-over design was employed. Two women with MS underwent two 20 min sessions of either 3 mA tDCS or Sham before 20 min of treadmill walking at a self-selected speed. During walking, the participants were injected with the glucose analogue, [ 18 F] fluorodeoxyglucose (FDG). Participants were then imaged to examine glucose metabolism and uptake asymmetries in the legs. Standardized uptake values (SUVs) were compared between the legs and asymmetry indices were calculated. Subject 2 was considered physically active (self-reported participating in at least 30 min of moderate-intensity physical activity on at least three days of the week for the last three months), while Subject 1 was physically inactive. In Subject 1, there was a decrease in SUVs at the left knee flexors, left upper leg, left and right plantar flexors, and left and right lower legs and SUVs in the knee extensors and dorsiflexors were considered symmetric after tDCS compared to Sham. Subject 2 showed an increase in SUVs at the left and right upper legs, right plantar flexors, and right lower leg with no muscle group changing asymmetry status. This study demonstrates that tDCS may increase neural drive to leg muscles and decrease glucose uptake during walking in PwMS with low physical activity levels.",2020,"Subject 2 showed an increase in SUVs at the left and right upper legs, right plantar flexors, and right lower leg with no muscle group changing asymmetry status.","['Two Women with Multiple Sclerosis', 'people with multiple sclerosis (PwMS', 'Two women with MS']","['Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', '3 mA tDCS or Sham before 20 min of treadmill walking at a self-selected speed', 'tDCS']","['Leg Muscle Glucose Uptake Asymmetry', 'Standardized uptake values (SUVs', 'SUVs at the left and right upper legs, right plantar flexors, and right lower leg', 'SUVs at the left knee flexors, left upper leg, left and right plantar flexors, and left and right lower legs and SUVs']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0230442', 'cui_str': 'Structure of right lower leg'}, {'cui': 'C4281599', 'cui_str': 'Structure of left knee region'}, {'cui': 'C0205091', 'cui_str': 'Left'}]",2.0,0.030917,"Subject 2 showed an increase in SUVs at the left and right upper legs, right plantar flexors, and right lower leg with no muscle group changing asymmetry status.","[{'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Fietsam', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Workman', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Laura L Boles', 'Initials': 'LLB', 'LastName': 'Ponto', 'Affiliation': 'Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kamholz', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Rudroff', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}]",Brain sciences,['10.3390/brainsci10080549']
1928,32823519,On Performance and Perceived Effort in Trail Runners Using Sensor Control to Generate Biosynchronous Music.,"Music has been shown to be capable of improving runners' performance in treadmill and laboratory-based experiments. This paper evaluates a generative music system, namely HEARTBEATS, designed to create biosignal synchronous music in real-time according to an individual athlete's heartrate or cadence (steps per minute). The tempo, melody, and timbral features of the generated music are modulated according to biosensor input from each runner using a combination of PPG (Photoplethysmography) and GPS (Global Positioning System) from a wearable sensor, synchronized via Bluetooth. We compare the relative performance of athletes listening to music with heartrate and cadence synchronous tempos, across a randomized trial (N = 54) on a trail course with 76 ft of elevation. Participants were instructed to continue until their self-reported perceived effort went beyond an 18 using the Borg rating of perceived exertion. We found that cadence-synchronous music improved performance and decreased perceived effort in male runners. For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested. This work has implications for the future design and implementation of novel portable music systems and in music-assisted coaching.",2020,"For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested.","['male runners', 'Trail Runners Using Sensor Control to Generate Biosynchronous Music']",['athletes listening to music with heartrate and cadence synchronous tempos'],[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}]",[],,0.175,"For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested.","[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'School of Computing, Science & Engineering, the University of Salford, the Crescent, Salford M5 4WT, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fazenda', 'Affiliation': 'School of Computing, Science & Engineering, the University of Salford, the Crescent, Salford M5 4WT, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Williamson', 'Affiliation': 'Lucerne University of Applied Sciences and Arts, 6002 Luzern, Switzerland.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Fazekas', 'Affiliation': 'School of Electronic Engineering and Computer Science, Queen Mary University of London, London E1 4FZ, UK.'}]","Sensors (Basel, Switzerland)",['10.3390/s20164528']
1929,32823594,Effects of  CYP1A2  and  ADORA2A  Genotypes on the Ergogenic Response to Caffeine in Professional Handball Players.,"Previous investigations have found that several genes may be associated with the interindividual variability to the ergogenic response to caffeine. The aim of this study is to analyze the influence of the genetic variations in  CYP1A2  (-163C  > A, rs762551; characterized such as ""fast"" (AA genotype) and ""slow"" caffeine metabolizers (C-carriers)) and  ADORA2A  (1976T  > C; rs5751876; characterized by ""high"" (TT genotype) or ""low"" sensitivity to caffeine (C-carriers)) on the ergogenic response to acute caffeine intake in professional handball players. Thirty-one professional handball players (sixteen men and fifteen women; daily caffeine intake = 60 ± 25 mg·d -1 ) ingested 3 mg·kg -1 ·body mass (bm) of caffeine or placebo 60 min before undergoing a battery of performance tests consisting of a countermovement jump (CMJ), a sprint test, an agility test, an isometric handgrip test, and several ball throws. Afterwards, the handball players performed a simulated handball match (2 × 20 min) while movements were recorded using inertial units. Saliva samples were analyzed to determine the genotype of each player for the -163C  > A polymorphism in the  CYP1A2  gene (rs762551) and for the 1976T  > C polymorphism in the  ADORA2A  gene (rs5751876). In the  CYP1A2 , C-allele carriers (54.8%) were compared to AA homozygotes (45.2%). In the  ADORA2A , C-allele carriers (80.6%) were compared to TT homozygotes (19.4%). There was only a genotype x treatment interaction for the ball throwing from 7 m ( p  = 0.037) indicating that the ergogenic effect of caffeine on this test was higher in  CYP1A2  AA homozygotes than in C-allele carriers. In the remaining variables, there were no genotype x treatment interactions for  CYP1A2  or for  ADORA2A . As a whole group, caffeine increased CMJ height, performance in the sprint velocity test, and ball throwing velocity from 9 m (2.8-4.3%,  p  = 0.001-0.022, effect size = 0.17-0.31). Thus, pre-exercise caffeine supplementation at a dose of 3 mg·kg -1 ·bm can be considered as an ergogenic strategy to enhance some neuromuscular aspects of handball performance in professional handball players with low daily caffeine consumption. However, the ergogenic response to acute caffeine intake was not modulated by  CYP1A2  or  ADORA2A  genotypes.",2020,There was only a genotype x treatment interaction for the ball throwing from 7 m ( p  = 0.037) indicating that the ergogenic effect of caffeine on this test was higher in  CYP1A2  AA homozygotes than in C-allele carriers.,"['professional handball players', 'Professional Handball Players', 'Thirty-one professional handball players (sixteen men and fifteen women; daily caffeine intake = 60 ± 25 mg·d -1 ) ingested 3 mg·kg -1 ·body mass (bm) of', 'professional handball players with low daily caffeine consumption']","['caffeine', 'Caffeine', 'high"" (TT genotype) or ""low"" sensitivity to caffeine (C-carriers', 'countermovement jump (CMJ), a sprint test, an agility test, an isometric handgrip test, and several ball throws', 'caffeine or placebo']","['genotype x treatment interaction', 'CMJ height, performance in the sprint velocity test, and ball throwing velocity']","[{'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}]",,0.0565286,There was only a genotype x treatment interaction for the ball throwing from 7 m ( p  = 0.037) indicating that the ergogenic effect of caffeine on this test was higher in  CYP1A2  AA homozygotes than in C-allele carriers.,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': 'Exercise and Sport Sciences, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'López-Samanes', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Millán', 'Initials': 'M', 'LastName': 'Aguilar-Navarro', 'Affiliation': 'Exercise and Sport Sciences, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Varillas-Delgado', 'Affiliation': 'Faculty of Medicine, Research Unit, Universidad Francisco de Vitoria, 28223 Pozuelo de Alarcon, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rivilla-García', 'Affiliation': 'Faculty of Physical Activity and Sports Sciences (INEF), Universidad Politécnica de Madrid (UPM), 28040 Madrid, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Moreno-Pérez', 'Affiliation': 'Sports Research Centre, Miguel Hernandez University of Elche, 03202 Alicante, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943 Fuenlabrada, Madrid, Spain.'}]",Genes,['10.3390/genes11080933']
1930,32823599,Displacing Sedentary Behaviour with Light Intensity Physical Activity Spontaneously Alters Habitual Macronutrient Intake and Enhances Dietary Quality in Older Females.,"Displacing Sedentary Behaviour (SB) with light intensity physical activity (LIPA) is increasingly viewed as a viable means of health enhancement. It is, however, unclear whether any behavioural compensations accompany such an intervention. Therefore, the aim of this study was to identify any dietary changes that accompany SB displacement. We hypothesised that SB displacement would improve dietary quality. Thirty-five elderly females (73 ± 5 years) were randomly allocated to one of three groups: (1) sedentary behaviour fragmentation (SBF) ( n  = 14), (2) continuous LIPA ( n  = 14), or (3) control ( n  = 7). Habitual diet (four-day food diary) and physical behaviour (accelerometery) were assessed at weeks 0 and 8. Out of 45 nutrients examined, only glucose exhibited a group × time interaction ( p  = 0.03), mediated by an exclusive reduction following SBF (-31%). SBF was also the sole experimental group to increase nutrients promoting bone health (SBF: 17%, LIPA: -34%. control: 21%), whereas both experimental groups consumed more nutrients promoting anabolism (SBF: 13%, LIPA: 4%, control: -34%) (z-scores). New ambulators ( n  = 8) also consumed more nutrients promoting bone health (16%)/anabolism (2%) (z-scores), including significantly increased Zinc intake ( p  = 0.05, 29%). Displacing SB with LIPA improves dietary quality in older females. Furthermore, SB fragmentation appears advantageous for various dietary outcomes.",2020,"New ambulators ( n  = 8) also consumed more nutrients promoting bone health (16%)/anabolism (2%) (z-scores), including significantly increased Zinc intake ( p  = 0.05, 29%).","['older females', 'Thirty-five elderly females (73 ± 5 years', 'Older Females']","['Displacing SB with LIPA', 'Light Intensity Physical Activity Spontaneously Alters Habitual Macronutrient Intake', 'Displacing Sedentary Behaviour (SB) with light intensity physical activity (LIPA', 'LIPA', 'sedentary behaviour fragmentation (SBF', 'SB displacement', 'continuous LIPA', 'SBF']","['nutrients promoting anabolism', 'nutrients promoting bone health (16%)/anabolism', 'dietary quality', 'nutrients promoting bone health', 'Zinc intake']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}]",35.0,0.0197407,"New ambulators ( n  = 8) also consumed more nutrients promoting bone health (16%)/anabolism (2%) (z-scores), including significantly increased Zinc intake ( p  = 0.05, 29%).","[{'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Grant', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tomlinson', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""School of Life Sciences, Faculty of Medicine & Health Sciences, The University of Nottingham Medical School, Queen's Medical Centre, Nottingham NG7 2UH, UK.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Kolic', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Onambele-Pearson', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}]",Nutrients,['10.3390/nu12082431']
1931,32823606,Multiple Micronutrients and Docosahexaenoic Acid Supplementation during Pregnancy: A Randomized Controlled Study.,"Maternal dietary intake during pregnancy needs to meet increased nutritional demands to maintain metabolism and to support fetal development. Docosahexaenoic acid (DHA) is essential for fetal neuro-/visual development and in immunomodulation, accumulating rapidly within the developing brain and central nervous system. Levels available to the fetus are governed by the maternal diet. In this multicenter, parallel, randomized controlled trial, we evaluated once-daily supplementation with multiple micronutrients and DHA (i.e., multiple micronutrient supplementation, MMS) on maternal biomarkers and infant anthropometric parameters during the second and third trimesters of pregnancy compared with no supplementation. Primary efficacy endpoint: change in maternal red blood cell (RBC) DHA ( wt % total fatty acids) during the study. Secondary variables: other biomarkers of fatty acid and oxidative status, vitamin D, and infant anthropometric parameters at delivery. Supplementation significantly increased RBC DHA levels, the omega-3 index, and vitamin D levels. Subscapular skinfold thickness was significantly greater with MMS in infants. Safety outcomes were comparable between groups. This first randomized controlled trial of supplementation with multiple micronutrients and DHA in pregnant women indicated that MMS significantly improved maternal DHA and vitamin D status in an industrialized setting-an important finding considering the essential roles of DHA and vitamin D.",2020,"Supplementation significantly increased RBC DHA levels, the omega-3 index, and vitamin D levels.","['during Pregnancy', 'pregnant women']","['Docosahexaenoic Acid Supplementation', 'MMS', 'multiple micronutrients and DHA (i.e., multiple micronutrient supplementation, MMS', 'Docosahexaenoic acid (DHA']","['Safety outcomes', 'Subscapular skinfold thickness', 'maternal DHA and vitamin D status', 'maternal red blood cell (RBC) DHA ( wt % total fatty acids', 'Maternal dietary intake', 'maternal biomarkers and infant anthropometric parameters', 'biomarkers of fatty acid and oxidative status, vitamin D, and infant anthropometric parameters at delivery', 'RBC DHA levels, the omega-3 index, and vitamin D levels']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0025706', 'cui_str': 'Methylmesilate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0829976,"Supplementation significantly increased RBC DHA levels, the omega-3 index, and vitamin D levels.","[{'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Massari', 'Affiliation': 'Department of Woman, Mother and Neonate, Buzzi Children Hospital, ASST Fatebenefratelli Sacco, 20154 Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Novielli', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Mandò', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Di Francesco', 'Affiliation': 'Department of Woman, Mother and Neonate, Buzzi Children Hospital, ASST Fatebenefratelli Sacco, 20154 Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Della Porta', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cazzola', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Panteghini', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Savasi', 'Affiliation': 'Department of Woman, Mother and Neonate, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, 20157 Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Maggini', 'Affiliation': 'Bayer Consumer Care AG, 4002 Basel, Switzerland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Schaefer', 'Affiliation': 'Bayer Consumer Care AG, 4002 Basel, Switzerland.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cetin', 'Affiliation': 'Department of Woman, Mother and Neonate, Buzzi Children Hospital, ASST Fatebenefratelli Sacco, 20154 Milan, Italy.'}]",Nutrients,['10.3390/nu12082432']
1932,32823682,Antibiotics Effects on the Fecal Metabolome in Preterm Infants.,"Within a randomized prospective pilot study of preterm infants born at less than 33 weeks' gestation, weekly fecal samples from 19 infants were collected and metabolomic analysis was performed. The objective was to evaluate for differences in fecal metabolites in infants exposed to antibiotics vs. not exposed to antibiotics in the first 48 h after birth. Metabolomics analysis was performed on 123 stool samples. Significant differences were seen in the antibiotics vs. no antibiotics groups, including pathways related to vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters. Early antibiotic exposure in preterm infants may alter metabolites in the intestinal tract of preterm infants. Broader multi-omic studies that address mechanisms will guide more prudent antibiotic use in this population.",2020,"Significant differences were seen in the antibiotics vs. no antibiotics groups, including pathways related to vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters.","[""preterm infants born at less than 33 weeks' gestation, weekly fecal samples from 19 infants"", 'Preterm Infants', 'preterm infants']",[],"['vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters', 'fecal metabolites', 'Fecal Metabolome']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",19.0,0.127272,"Significant differences were seen in the antibiotics vs. no antibiotics groups, including pathways related to vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Patton', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Garrett', 'Affiliation': 'Department of Pathology, Immunology and Laboratory Medicine, College of Medicine, University of Florida, Gainesville, FL 32610, USA.'}, {'ForeName': 'J Lauren', 'Initials': 'JL', 'LastName': 'Ruoss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Jordan T', 'Initials': 'JT', 'LastName': 'Russell', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL 32603, USA.'}, {'ForeName': 'Diomel', 'Initials': 'D', 'LastName': 'de la Cruz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Bazacliu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Polin', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Triplett', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL 32603, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Neu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}]",Metabolites,['10.3390/metabo10080331']
1933,32823720,Comparison of Opioid-Free Anesthesia Versus Opioid-Containing Anesthesia for Elective Laparoscopic Surgery (COFA: LAP): A Protocol Measuring Recovery Outcomes.,"The administration of opioids is a central element in contemporary anesthetic techniques in Australia; however, opioids have a range of side effects. As an alternative, opioid-free anesthesia (OFA) is an emerging mode of anesthesia intended to avoid these side effects. This study is the first to publish the use of OFA in Australia and is conducted in a regional Queensland Health Service. The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40). Participant outcomes to be measured include: Quality of Recovery (QoR-15); Oral Morphine Equivalent Daily Dose (OMEDD) at 24-h post-operatively; time to first opioid (TTFO) dose; post-operative nausea and vomiting (PONV); Post Anesthetic Care Unit length of stay (PACU-LOS); and hospital length of stay (LOS). The findings may challenge the essentiality of opioids in the peri-operative period, which in turn would influence the future intra-operative management of surgical patients. Ultimately, a reduction in anesthesia-associated opioid use will support a more general decline in opioid use.",2020,The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40).,['patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40'],"['Opioid-Containing Anesthesia', 'opioids', 'opioid-free anesthesia (OFA', 'OFA', 'COFA: LAP', 'Elective Laparoscopic Surgery', 'Opioid-Free Anesthesia']",[' Quality of Recovery (QoR-15); Oral Morphine Equivalent Daily Dose (OMEDD) at 24-h post-operatively; time to first opioid (TTFO) dose; post-operative nausea and vomiting (PONV); Post Anesthetic Care Unit length of stay (PACU-LOS); and hospital length of stay (LOS'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0520483', 'cui_str': 'Ligation of fallopian tube'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]",,0.0797404,The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Eidan', 'Affiliation': 'Anesthetic Department, Bundaberg Hospital, Wide Bay Hospital and Health Service, Bundaberg 4670, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ratsch', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Burmeister', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}]",Methods and protocols,['10.3390/mps3030058']
1934,32823733,No Effects of New Zealand Blackcurrant Extract on Physiological and Performance Responses in Trained Male Cyclists Undertaking Repeated Testing across a Week Period.,"Anthocyanin supplements are receiving attention due to purported benefits to physiological, metabolic, and exercise responses in trained individuals. However, the efficacy of anthocyanin intake over multiple testing days is not known. We compared a placebo and two doses of anthocyanin-rich New Zealand blackcurrant (NZBC) extract (300 and 600 mg·day -1 ) on plasma lactate, substrate oxidation, and 16.1 km time trial (TT) performance on three occasions over 7-days in a fed state (day 1 (D1), D4, and D7). Thirteen male cyclists participated in a randomized, crossover, placebo-controlled double-blind design. There was no difference in plasma lactate and substrate oxidation between conditions and between days. A time difference was observed between D1 (1701 ± 163 s) and D4 (1682 ± 162 s) for 600 mg ( p  = 0.05), with an increment in average speed (D1 = 34.3 ± 3.4 vs. D4 = 34.8 ± 3.4 km·h -1 ,  p  = 0.04). However, there was no difference between the other days and between conditions. Overall, one week of intake of NZBC extract did not affect physiological and metabolic responses. Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.",2020,Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.,"['Trained Male Cyclists', 'Thirteen male cyclists']","['New Zealand Blackcurrant Extract', 'Anthocyanin supplements', 'NZBC extract', 'anthocyanin-rich New Zealand blackcurrant (NZBC) extract', 'placebo']","['Physiological and Performance Responses', 'physiological and metabolic responses', 'plasma lactate, substrate oxidation, and 16.1 km time trial (TT) performance', 'plasma lactate and substrate oxidation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",13.0,0.300606,Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Montanari', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Mehmet A', 'Initials': 'MA', 'LastName': 'Şahin', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Sam D', 'Initials': 'SD', 'LastName': 'Blacker', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8080114']
1935,32823771,"Mobile-Based Lifestyle Intervention in Women with Glucose Intolerance after Gestational Diabetes Mellitus (MELINDA), A Multicenter Randomized Controlled Trial: Methodology and Design.","The aims of the 'Mobile-based lifestyle intervention in women with glucose intolerance after gestational diabetes mellitus (GDM)' study (MELINDA) are: (1) to evaluate the prevalence and risk factors of glucose intolerance after a recent history of GDM; and (2) to evaluate the efficacy and feasibility of a telephone- and mobile-based lifestyle intervention in women with glucose intolerance after GDM. This is a Belgian multicenter randomized controlled trial (RCT) in seven hospitals with the aim of recruiting 236 women. Women in the intervention group will receive a blended program, based on one face-to-face education session and further follow-up through a mobile application and monthly telephone advice. Women in the control group will receive follow-up as in normal routine with referral to primary care. Participants will receive an oral glucose tolerance test (OGTT) one year after baseline. Primary endpoint is the frequency of weight goal achievement (≥5% weight loss if pre-pregnancy BMI ≥ 25 Kg/m 2  or return to pre-gravid weight if BMI < 25 Kg/m 2 ). At each visit blood samples are collected, anthropometric measurements are obtained, and self-administered questionnaires are completed. Recruitment began in May 2019.",2020,< 25 Kg,"['Women with Glucose Intolerance after Gestational Diabetes Mellitus', ' 25 Kg', 'women with glucose intolerance after GDM', 'seven hospitals with the aim of recruiting 236 women', 'women with glucose intolerance after gestational diabetes mellitus (GDM']","['blended program, based on one face-to-face education session and further follow-up through a mobile application and monthly telephone advice', 'oral glucose tolerance test (OGTT', 'Mobile-based lifestyle intervention', 'telephone- and mobile-based lifestyle intervention', 'Mobile-Based Lifestyle Intervention']",['frequency of weight goal achievement (≥5% weight loss if pre-pregnancy BMI ≥'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",236.0,0.0914501,< 25 Kg,"[{'ForeName': 'Caro', 'Initials': 'C', 'LastName': 'Minschart', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Toon', 'Initials': 'T', 'LastName': 'Maes', 'Affiliation': 'Department of Endocrinology, Imelda Hospital, 2820 Bonheiden, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'De Block', 'Affiliation': 'Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, 2650 Edegem, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Van Pottelbergh', 'Affiliation': 'Department of Endocrinology, OLV Hospital Aalst, 9300 Aalst, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Myngheer', 'Affiliation': 'Department of Endocrinology, General Hospital Groeninge, 8510 Kortrijk, Belgium.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Department of Endocrinology, GZA Hospital Sint-Vincentius, 2018 Antwerp, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Vinck', 'Affiliation': 'Department of Endocrinology, GZA Hospital Sint-Augustinus, 2610 Wilrijk, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Leuridan', 'Affiliation': 'Department of Endocrinology, General Hospital Klina, 2930 Brasschaat, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Billen', 'Affiliation': 'Department of Laboratory Medicine, University Hospitals Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Matthys', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Babs', 'Initials': 'B', 'LastName': 'Weyn', 'Affiliation': 'Department of Electrical Engineering, Processing Speech and Images, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Annouschka', 'Initials': 'A', 'LastName': 'Laenen', 'Affiliation': 'Centre of Biostatics and Statistical Bioinformatics, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Benhalima', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9082635']
1936,32823828,Physical Fitness Promotion among Adolescents: Effects of a Jump Rope-Based Physical Activity Afterschool Program.,"The major purpose of this study was to examine the effects of a jump rope-based physical activity afterschool program on middle school students' physical fitness. Sixty students ( M age  = 13.37,  SD  = 0.58; 53.3% female) participated in a 12-week jump rope-based afterschool program (45 min/time, three times/week). Participants were randomly assigned to three groups: (a) freestyle rope skipping ( N  = 20), traditional jump rope ( N  = 20), and a control group ( N  = 20). Physical fitness tests, including muscular strength (standing long jump, right-hand grip, and left-hand grip), flexibility, body composition, and bone mineral density (BMD) were measured in pre- and post-tests. A 2 (time) × 3 (groups) repeated measure multivariate analysis of variance (MANOVA) was performed. The results found significant improvements in muscular strength (standing long jump, right-hand grip, and left-hand grip) in both intervention groups ( p  < 0.001;  d s = 0.2-0.44). Only the freestyle rope skipping group had increased BMD ( p  < 0.05,  d  = 0.33). Compared to the traditional jump rope, the freestyle rope skipping group showed significantly higher improvement in flexibility ( p  < 0.05,  d  = 0.83). These findings suggest that the jump rope-based afterschool program with freestyle rope skipping would be more effective than traditional jump rope to promote physical fitness performance among adolescents.",2020,"The results found significant improvements in muscular strength (standing long jump, right-hand grip, and left-hand grip) in both intervention groups ( p  < 0.001;  d s = 0.2-0.44).","[""middle school students' physical fitness"", 'Adolescents', 'adolescents', 'Sixty students ( M age  = 13.37,  SD  = 0.58; 53.3% female']","['freestyle rope skipping ( N  = 20), traditional jump rope', 'Jump Rope-Based Physical Activity Afterschool Program', 'jump rope-based afterschool program', 'jump rope-based physical activity afterschool program']","['flexibility', 'Physical fitness tests, including muscular strength (standing long jump, right-hand grip, and left-hand grip), flexibility, body composition, and bone mineral density (BMD', 'muscular strength (standing long jump, right-hand grip, and left-hand grip', 'BMD']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",60.0,0.0137646,"The results found significant improvements in muscular strength (standing long jump, right-hand grip, and left-hand grip) in both intervention groups ( p  < 0.001;  d s = 0.2-0.44).","[{'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'School of Leisure Sport, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Joonyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Xiangli', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington, Arlington, TX 76019, USA.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington, Arlington, TX 76019, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, TX 76203, USA.'}]","Children (Basel, Switzerland)",['10.3390/children7080095']
1937,32823850,Tunnel/Pouch versus Coronally Advanced Flap Combined with a Connective Tissue Graft for the Treatment of Maxillary Gingival Recessions: Four-Year Follow-Up of a Randomized Controlled Trial.,"BACKGROUND


The long-term stability after soft tissue graft for covering gingival recession remains a pivotal goal for both patient and periodontist. Therefore, the aim of this study was to compare the four-year outcomes of the coronally advanced flap (CAF) versus the pouch/tunnel (POT) technique, both combined with connective tissue graft (CTG), for gingival recession treatment.
METHODS


Forty patients were initially randomly assigned to the control group (CAF + CTG; N = 20) and the test group (POT + CTG; N = 20). Clinical outcomes included mean root coverage (MRC) and complete root coverage (CRC), gingival thickness (GT), and keratinized tissue (KT) gain. Esthetic outcomes were also analyzed using the pink esthetic score (PES) and patient-reported outcome measures (PROMs). All outcomes initially assessed at six months were extended to four years post-surgery.
RESULTS


No significant differences were observed between the two patient groups in terms of MRC and CRC. At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
CONCLUSIONS


The POT + CTG technique allows for long-term clinical coverage of gingival recessions comparable to that of the CAF + CTG technique, but it potentially improves gingival thickness, keratinized tissue and esthetic results.",2020,"At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
","['Maxillary Gingival Recessions', 'Forty patients']","['POT + CTG', 'Tunnel/Pouch versus Coronally Advanced Flap Combined with a Connective Tissue Graft', 'POT + CTG technique', 'coronally advanced flap (CAF) versus the pouch/tunnel (POT) technique, both combined with connective tissue graft (CTG', 'control group (CAF + CTG']","['tissue texture enhancement', 'MRC and CRC', 'pink esthetic score (PES) and patient-reported outcome measures (PROMs', 'GT and KT gain', 'mean root coverage (MRC) and complete root coverage (CRC), gingival thickness (GT), and keratinized tissue (KT) gain', 'gingival thickness, keratinized tissue and esthetic results']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4319584', 'cui_str': 'Pouch'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",40.0,0.052694,"At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
","[{'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Salem', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Salhi', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Seidel', 'Affiliation': 'Biostatistics and Medico-Economic Information, University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rompen', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9082641']
1938,32823886,A High Polyphenol Diet Improves Psychological Well-Being: The Polyphenol Intervention Trial (PPhIT).,"Mental ill health is currently one of the leading causes of disease burden worldwide. A growing body of data has emerged supporting the role of diet, especially polyphenols, which have anxiolytic and antidepressant-like properties. The aim of the present study was to assess the effect of a high polyphenol diet (HPD) compared to a low polyphenol diet (LPD) on aspects of psychological well-being in the Polyphenol Intervention Trial (PPhIT). Ninety-nine mildly hypertensive participants aged 40-65 years were enrolled in a four-week LPD washout period and then randomised to either an LPD or an HPD for eight weeks. Both at baseline and the end of intervention, participants' lifestyle and psychological well-being were assessed. The participants in the HPD group reported a decrease in depressive symptoms, as assessed by the Beck Depression Inventory-II, and an improvement in physical component and mental health component scores as assessed with 36-Item Short Form Survey. No differences in anxiety, stress, self-esteem or body image perception were observed. In summary, the study findings suggest that the adoption of a polyphenol-rich diet could potentially lead to beneficial effects including a reduction in depressive symptoms and improvements in general mental health status and physical health in hypertensive participants.",2020,"The participants in the HPD group reported a decrease in depressive symptoms, as assessed by the Beck Depression Inventory-II, and an improvement in physical component and mental health component scores as assessed with 36-Item Short Form Survey.","['Ninety-nine mildly hypertensive participants aged 40-65 years', 'hypertensive participants']","['low polyphenol diet (LPD', 'high polyphenol diet (HPD', 'polyphenol-rich diet', 'Polyphenol Diet', 'LPD or an HPD']","['physical component and mental health component scores', 'general mental health status and physical health', 'anxiety, stress, self-esteem or body image perception', 'depressive symptoms']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",99.0,0.0281013,"The participants in the HPD group reported a decrease in depressive symptoms, as assessed by the Beck Depression Inventory-II, and an improvement in physical component and mental health component scores as assessed with 36-Item Short Form Survey.","[{'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, Eleftheriou Venizelou 70, 17671 Kallithea, Greece.'}, {'ForeName': 'Aswathy', 'Initials': 'A', 'LastName': 'Vijayakumar', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Rooney', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Noad', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Appleton', 'Affiliation': 'Department of Psychology, Bournemouth University, Bournemouth BH12 5BB, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': ""Institute for Global Food Security, Queen's University Belfast, Belfast BT9 5DL, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Donnelly', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Young', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'McKinley', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Pascal P', 'Initials': 'PP', 'LastName': 'McKeown', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Jayne V', 'Initials': 'JV', 'LastName': 'Woodside', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}]",Nutrients,['10.3390/nu12082445']
1939,32798558,Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages.,"AIMS


We aimed to evaluate the effect of Dexmedetomidine (Dex) on immunology function of macrophages and inflammatory reactions in non-ventilated lung tissues from both humans and rats.
MAIN METHODS


Patients scheduled for lung lobectomy were randomly assigned to traditional anesthesia group or Dex anesthesia group, 15 subjects in each group. CD68, CD86 and CD206 were used to mark activate and polarized macrophages using immunofluorescence staining in human lung tissues. Sprague-Dawley rats were used to set lung injury model and randomly divided into Control group, one-lung ventilation group (CLI group) and CLI + Dex group. Lung tissues and bronchoalveolar lavage fluid (BALF) from non-ventilated lungs were collected. The acquired lung tissues were subjected to hematoxylin-eosin (H&E) staining and the inflammatory cells in BALF were calculated. Levels of cytokines and chemokines were detected by enzyme-linked immunosorbent assays (ELISA).
KEY FINDINGS


Results from humans showed that anesthesia with Dex decreased the number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1) in human lung. Results from rats demonstrated that treatment with Dex reversed the increased inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif) ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
SIGNIFICANCE


This study showed that Dex modulated the activation and immunological function of macrophages in non-ventilated lung and revealed a protective role in collapsed lung injury.",2020,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","['Patients scheduled for lung lobectomy', 'non-ventilated lung tissues from both humans and rats']","['traditional anesthesia group or Dex anesthesia', 'Dexmedetomidine (Dex', 'Control group, one-lung ventilation group (CLI group) and CLI\u202f+\u202fDex group', 'Dexmedetomidine', 'Dex']","['inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif', 'Levels of cytokines and chemokines', 'immunology function of macrophages and inflammatory reactions', 'Lung tissues and bronchoalveolar lavage fluid (BALF', 'number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1', 'anti-inflammatory cytokine interleukin-10 (IL-10']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C1453673', 'cui_str': 'CLU protein, human'}]","[{'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",15.0,0.0272658,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","[{'ForeName': 'Qiying', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: shenqiying-yy@163.com.'}, {'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Department of Anesthesiology, the Fourth Affiliated Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Life sciences,['10.1016/j.lfs.2020.118249']
1940,32798761,A randomized controlled trial on irrigation of open appendectomy wound with gentamicin- saline solution versus saline solution for prevention of surgical site infection.,"BACKGROUND


Surgical site infection (SSI) is one of the most common complications after abdominal surgery. The present trial examined the efficacy of saline irrigation of open appendectomy wound with or without topical antibiotics in prevention of SSI.
METHODS


This was a double-blind randomized trial on patients with acute appendicitis who underwent open appendectomy. Patients were randomly allocated to one of three equal groups; group I had layer-by-layer wound irrigation with gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group). The main outcome measures were the incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction.
RESULTS


205 patients (113 female) of a mean age of 27.9 years were included. The average hospital stay and pain scores were similar in the three groups. Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p = 0.005) and SSO (24.6% Vs 13.4% Vs 43.5%; p = 0.0003) as compared to group III. Groups I and II had comparable rates of SSI and SSO. The three groups had similar rates of wound seroma, hematoma, and dehiscence. Groups I and II had significantly higher satisfaction with the procedure than group III.
CONCLUSIONS


Layer-by-layer irrigation of open appendectomy wound decreased the rates of incisional SSI and SSO significantly compared to the no-irrigation group. Adding gentamicin to saline solution was useless to improve the outcome and did not decrease rates of SSI or other complications.",2020,"Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p= 0.005) and SSO (24.6 %","['patients with acute appendicitis who underwent open appendectomy', '205 patients (113 female) of a mean age of 27.9 years were included']","['gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group', 'Gentamicin- Saline Solution versus Saline Solution', 'saline irrigation of open appendectomy wound with or without topical antibiotics', 'gentamicin to saline solution']","['SSO', 'rates of SSI and SSO', 'rates of incisional SSI', 'rates of wound seroma, hematoma, and dehiscence', 'average hospital stay and pain scores', ""incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction"", 'rates of incisional SSI and SSO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0406831', 'cui_str': 'Wound seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",205.0,0.0751698,"Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p= 0.005) and SSO (24.6 %","[{'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: Sameh200@hotmail.com.'}, {'ForeName': 'Ahmed Hossam', 'Initials': 'AH', 'LastName': 'Elfallal', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: ahmedhos2011@gmail.com.'}, {'ForeName': 'Mohamed Anwar', 'Initials': 'MA', 'LastName': 'Abdel-Razik', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: drmohamedanwar1981@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Said', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: mmelsaidshehab@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elshobaky', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: elshobakyayman@yahoo.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.057']
1941,32798787,"Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial.","AIMS


To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF).
METHODS AND RESULTS


Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6].
CONCLUSION


In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.",2020,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","['age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy', 'patients with heart failure (HF) and reduced ejection fraction (HFrEF', '582', 'Patients with mildly symptomatic HFrEF, mean (standard deviation (SD', 'patients with heart failure and reduced ejection fraction']","['Placebo', 'empagliflozin', 'sodium-glucose co-transporter-2 inhibitor empagliflozin', 'empagliflozin/placebo', 'HF therapy, empagliflozin', 'Empagliflozin', 'empagliflozin 10 mg once daily or placebo', 'placebo']","['daily activity level or health status', 'change of NT-proBNP', 'accelerometer-measured daily activity level', 'median (interquartile range (IQR', 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",95.0,0.793933,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark. Electronic address: jesper.jensen.06@regionh.dk.'}, {'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Mikael Kjær', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Internal Medicine, Center of Endocrinology and Metabolism, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Sygehusvej 10, 4000 Roskilde, Denmark; Clinical Institute, Aalborg University, Søndre Skovvej 15, 9000 Aalborg, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jan Christian', 'Initials': 'JC', 'LastName': 'Brønd', 'Affiliation': 'RICH/EXE, Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Julie Lyng', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.07.011']
1942,32799565,Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects.,"OBJECTIVE


The aim of the present study was to assess the bioequivalence of a generic empagliflozin tablet versus a brand-named empagliflozin tablet (Jardiance ® ) and evaluate the food effects on the pharmacokinetics (PK) of empagliflozin in healthy Chinese subjects.
METHODS


Forty-eight healthy volunteers were included in this randomized, open-label, crossover, two-period study (fasting:  n  = 24, fed:  n  = 24). A single dose of 25-mg generic (or test) or brand-named (or reference) empagliflozin was administered to each subject in a randomized sequence. Blood samples were collected at the baseline and during the 72 h post-dose, and plasma empagliflozin concentrations were determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Pharmacokinetic parameters were analyzed with non-compartmental methods. Safety was monitored.
RESULTS


The major PK parameters including  C   max , AUC 0-   t  , and AUC 0-∞  were similar between the generic and brand-named tablets under fasting and fed conditions (all  p  > .05). The 90% confidence intervals of the test/reference ratios of log-transformed  C   max , AUC 0-   t  , and AUC 0-∞  were 94.90-106.70%, 100.62-106.99%, and 100.64-106.85%, respectively, under fasting condition, and 94.21-104.91%, 97.31-101.79%, and 97.32-101.83%, respectively, under fed condition. High-fat food did not affect  C   max , AUC 0-   t  , AUC 0-∞ , or  T   max  of empagliflozin (all  p  > .05). There was no serious adverse event during the study period.
CONCLUSION


The generic formulation of empagliflozin tablet is bioequivalent to the brand-named product in healthy Chinese volunteers, and well tolerated. High-fat food had no effects on the PK of empagliflozin in healthy Chinese volunteers.",2020,"High-fat food did not affect C max , AUC 0-t ,","['Methods:  Forty-eight healthy volunteers', 'healthy Chinese subjects', 'healthy Chinese volunteers']","['empagliflozin', 'generic empagliflozin', 'generic empagliflozin tablet  versus  a brand-named empagliflozin tablet (Jardiance®', '25-mg generic (or test) or brand-named (or reference) empagliflozin', 'empagliflozin ']","['tolerated', 'Blood samples', 'C max , AUC 0-t ', 'plasma empagliflozin concentrations', 'reference ratios of log-transformed C max , AUC 0-t  and AUC 0-∞', 'C max , AUC 0-t  and AUC 0-∞']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C3848959', 'cui_str': 'empagliflozin Oral Tablet'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C3848669', 'cui_str': 'Jardiance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",48.0,0.0296417,"High-fat food did not affect C max , AUC 0-t ,","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}]",Drug development and industrial pharmacy,['10.1080/03639045.2020.1810263']
1943,32799753,The immediate effect of the abdominal drawing-in maneuver technique on stature change in seated sedentary workers with chronic low back pain.,"Many studies have measured stature change arising from loads imposed on the spine during sitting. To improve stature recovery, it is important to stabilise the lumbar spine and compensate forces from the upper body. The abdominal drawing-in maneuver (ADIM) technique has been found to mainly activate deep trunk muscles. The purpose of this study was to determine whether activation of deep trunk muscles by the ADIM technique could immediately improve stature recovery during prolonged sitting. Twenty-four patients with chronic low back pain (CLBP) were randomly allocated into different orders of experimental conditions: control (sitting without ADIM technique) and intervention conditions (sitting with ADIM technique). The latter condition required participants to complete ADIM technique for 1 min and repeat it three times throughout 41 min prolonged sitting time. Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition ( p -value = 0.001). Our finding demonstrated that ADIM technique improved stature recovery.  Practitioner Summary:  Prolonged sitting seemingly harms sedentary workers' health, particularly affecting the lower back. Activation of deep trunk muscles using abdominal drawing-in maneuver technique can promote spinal recovery. Clinicians can teach abdominal drawing-in maneuver technique to activate deep trunk muscles in chronic low back pain, thereby promoting self-management of seated stature recovery.  Abbrevations:  ADIM: abdominal drawing-in maneuver; RA: rectus abdominis; ICLT: iliocostalis lumborum pars thoracis; LM: lumbar multifidus; TrA: transversus abdominis; IO: internal oblique; CLBP: chronic low back pain; LBP: low back pain; RMDQ: Roland Morris disability questionnaire; NRS: numerical rating scale.",2020,Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition (p-value =0.001).,"['Twenty-four patients with chronic low back pain (CLBP', 'seated sedentary workers with chronic low back pain']","['abdominal drawing-in maneuver technique', 'experimental conditions: control (sitting without ADIM technique) and intervention conditions (sitting with ADIM technique']","['stature recovery', 'Stature recovery']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}]",24.0,0.0123001,Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition (p-value =0.001).,"[{'ForeName': 'Pongsatorn', 'Initials': 'P', 'LastName': 'Saiklang', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Rungthip', 'Initials': 'R', 'LastName': 'Puntumetakul', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Manida', 'Initials': 'M', 'LastName': 'Swangnetr Neubert', 'Affiliation': 'Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Boucaut', 'Affiliation': 'International Centre for Allied Health Evidence, University of South Australia, Adelaide, Australia.'}]",Ergonomics,['10.1080/00140139.2020.1810326']
1944,32800909,Impact of cognitive behavioral therapy on depression symptoms after transcatheter aortic valve replacement: A randomized controlled trial.,"BACKGROUND


Depression is a significant concern after cardiac surgery and has not been studied in patients undergoing transcatheter aortic valve replacement (TAVR). We sought to examine the prevalence of pre-procedure depression and anxiety symptoms and explore whether brief bedside cognitive behavioral therapy (CBT) could prevent post-TAVR psychological distress.
METHODS


We prospectively recruited consecutive TAVR patients and randomized them to receive brief CBT or treatment as usual (TAU) during their hospitalization. Multi-level regression techniques were used to evaluate changes by treatment arm in depression, anxiety, and quality of life from baseline to 1 month post-TAVR adjusted for sex, race, DM, CHF, MMSE, and STS score.
RESULTS


One hundred and forty six participants were randomized. The mean age was 82 years, and 43% were female. Self-reported depression and anxiety scores meeting cutoffs for clinical level distress were 24.6% and 23.2% respectively. Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83). Similarly, both TAU and CBT groups had comparable improvements in anxiety symptoms at 1-month (8% reduction for TAU and 11% reduction for CBT, p = .1). Quality of life scores also improved and were not significantly different between the two groups.
CONCLUSIONS


Pre-procedure depression and anxiety may be common among patients undergoing TAVR. However, TAVR patients show spontaneous improvement in depression and anxiety scores at 1-month follow up, regardless of brief CBT. Further research is needed to determine whether more tailored CBT interventions may improve psychological and medical outcomes.",2020,"Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83).","['The mean age was 82\u202fyears, and 43% were female', 'patients undergoing transcatheter aortic valve replacement (TAVR', 'patients undergoing TAVR', 'One hundred and forty six participants were randomized', 'depression symptoms after transcatheter aortic valve replacement']","['bedside cognitive behavioral therapy (CBT', 'TAU and CBT', 'CBT or treatment as usual (TAU', 'cognitive behavioral therapy', 'TAVR']","['Quality of life scores', 'anxiety symptoms', 'depression, anxiety, and quality of life', 'depression and anxiety scores', 'depressive symptoms', 'Self-reported depression and anxiety scores meeting cutoffs for clinical level distress']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",146.0,0.118211,"Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83).","[{'ForeName': 'Katharine S', 'Initials': 'KS', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, Stanford University, United States of America. Electronic address: ksedwards@stanford.edu.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chow', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dao', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Derik', 'Initials': 'D', 'LastName': 'Hossepian', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, United States of America.'}, {'ForeName': 'Audrey G', 'Initials': 'AG', 'LastName': 'Johnson', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, United States of America.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, United States of America.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, United States of America.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fischbein', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, United States of America.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.08.007']
1945,32800962,The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury.,"There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 27,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. Few studies have reported the safety and efficacy for use of these devices in the home and community environments, and none evaluated their impact on patient-centered outcomes through a randomized clinical trial (RCT). Absence of reported RCTs for powered exoskeletons may be due to a range of challenges, including designing, statistically powering, and conducting such a trial within an appropriate experimental framework. An RCT for the study of exoskeletal-assisted walking in the home and community environments also requires the need to address key factors such as: avoiding selection bias, participant recruitment and retention, training, and safety concerns, particularly in the home environment. These points are described here in the context of a national, multisite Department of Veterans Affairs Cooperative Studies Program-sponsored trial. The rationale and methods for the study design were focused on providing a template for future studies that use powered exoskeletons or other strategies for walking and mobility in people with immobilization due to SCI.",2020,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"['persons with chronic spinal cord injury', 'Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care', 'people with immobilization due to SCI']",['exoskeletal-assisted walking'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0719972,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Spungen', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Ann.Spungen@va.gov.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: William.Bauman@va.gov.'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Kousick.Biswas@va.gov.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Jones', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Karen.Jones2@va.gov.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Snodgrass', 'Affiliation': 'VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM 87106, United States of America; University of New Mexico, College of Pharmacy, Albuquerque, NM 87106, United States of America. Electronic address: Amanda.Snodgrass@va.gov.'}, {'ForeName': 'Lance L', 'Initials': 'LL', 'LastName': 'Goetz', 'Affiliation': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA 23249, United States of America; Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA 23298, United States of America. Electronic address: Lance.Goetz@va.gov.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gorman', 'Affiliation': 'Department of Neurology, University of Maryland School of Medicine, Baltimore, MD 21201, United States of America; VA Maryland Healthcare System, Baltimore, MD 21201, United States of America. Electronic address: Pgorman@umm.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Institute for Rehabilitation, West Orange, NJ 07052, United States of America; Rutgers New Jersey Medical School, Newark, NJ 07103, United States of America; Kessler Foundation, West Orange, NJ 07052, United States of America. Electronic address: skirshblum@kessler-rehab.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sabharwal', 'Affiliation': 'VA Boston Health Care System, Boston, MA 02130, United States of America; Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA 02115, United States of America. Electronic address: Sunil.Sabharwal2@va.gov.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'White', 'Affiliation': ""James A Haley Veterans' Hospital, Tampa, FL 33612, United States of America; University of South Florida, Tampa, FL 33612, United States of America. Electronic address: Kevin.White2@va.gov.""}, {'ForeName': 'Pierre K', 'Initials': 'PK', 'LastName': 'Asselin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Pierre.Asselin@va.gov.'}, {'ForeName': 'Kel G', 'Initials': 'KG', 'LastName': 'Morin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America. Electronic address: Kel.Morin@va.gov.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America. Electronic address: Christopher.Cirnigliaro@va.gov.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Huang', 'Affiliation': 'Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC 20420, United States of America. Electronic address: Grant.Huang@va.gov.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106102']
1946,32801342,L-DOPA and consolidation of fear extinction learning among women with posttraumatic stress disorder.,"This study tested whether L-DOPA delivered during the consolidation window following fear extinction learning reduces subsequent fear responding among women with PTSD. Adult women diagnosed with PTSD completed a contextual fear acquisition and extinction task during fMRI and then immediately received either placebo (n = 34), 100/25 mg L-DOPA/carbidopa (n = 28), or 200/50 mg L-DOPA/carbidopa (n = 29). Participants completed a resting-state scan before the task and again 45 min following drug ingestion to characterize effects of L-DOPA on extinction memory neural reactivation patterns during consolidation. Twenty-four hours later, participants returned for tests of context renewal, extinction recall, and reinstatement during fMRI with concurrent skin conductance responding (SCR) assessment. Both active drug groups demonstrated increased reactivation of extinction encoding in the amygdala during the post-task resting-state scan. For SCR data, both drug groups exhibited decreased Day 2 reinstatement across all stimuli compared to placebo, and there was some evidence for decreased context renewal to the fear stimulus in the 100 mg group compared to placebo. For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo. There was no evidence in SCR or neural activity that L-DOPA improved extinction recall. Reactivation of extinction encodings in the amygdala during consolidation on Day 1 predicted Day 2 activation of the insula network. These results support a role for dopamine during the consolidation window in boosting reactivation of amygdala extinction encodings and reducing reinstatement, but not improving extinction recall, in women with PTSD.",2020,"For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo.","['women with PTSD', 'Adult women diagnosed with PTSD completed a contextual fear acquisition and extinction task during fMRI and then immediately received either', 'women with posttraumatic stress disorder']","['200/50\u2009mg L-DOPA/carbidopa', 'L-DOPA', '100/25\u2009mg L-DOPA/carbidopa', 'L-DOPA and consolidation of fear extinction learning', 'placebo']","['reactivation of extinction encoding', 'SCR or neural activity that L-DOPA improved extinction recall']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0800658,"For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo.","[{'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Cisler', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA. jcisler2@wisc.edu.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Privratsky', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}, {'ForeName': 'Anneliis', 'Initials': 'A', 'LastName': 'Sartin-Tarm', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Kyrie', 'Initials': 'K', 'LastName': 'Sellnow', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Weaver', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hahn', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Herringa', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'George Andrew', 'Initials': 'GA', 'LastName': 'James', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}, {'ForeName': 'Clinton D', 'Initials': 'CD', 'LastName': 'Kilts', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}]",Translational psychiatry,['10.1038/s41398-020-00975-3']
1947,32804837,Comparative study of allicin-containing quadruple therapy vs. bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection: a prospective randomized study.,"BACKGROUND


Bismuth has antimicrobial activity and can improve the efficacy of triple Helicobacter pylori (H. pylori) therapy. Allicin added to conventional therapy for H. pylori infection also improves H. pylori eradication rates. Thus, this study aims to evaluate and compare the efficacy, safety and tolerability of allicin-containing quadruple therapy and bismuth-containing quadruple therapy and to investigate the factors that affect the eradication rates.
METHODS


Two hundred twenty H. pylori-infected patients were included and randomly (1:1) assigned to 14-day quadruple therapy: ilaprazole (5 mg bid), doxycycline (100 mg bid), and furazolidone (100 mg bid) with an allicin soft capsule (40 mg of DATS tid) (IDFA) or colloidal bismuth tartrate (220 mg of elemental bismuth bid) (IDFB). Eradication was confirmed by urea breath tests. Symptom improvement, adverse events, and adherence were assessed by a questionnaire.
RESULTS


In the intention-to-treat and per-protocol analysis, the eradication rates for IDFA and IDFB groups were 87.5% (70/80) vs. 86.3% (69/80, P = 0.815) and 91.9% (68/74) vs. 91.8% (67/73, P = 0.980) as first-line therapies; 83.3% (25/30) vs. 83.3% (25/30, P = 1) and 89.3% (25/28) vs. 88.9% (24/27, P = 1) as second-line therapies. Symptom improvement rates were 96.1% and 97.0% for IDFA and IDFB (P = 1). The adverse event rates were 10.9% in IDFA and 14.5% in IDFB groups (P = 0.418). Nausea occurred frequently in IDFB than IDFA (1.8% vs. 8.2%, P = 0.030). Smoking and sharing utensils significantly affected the efficacy.
CONCLUSION


Allicin-containing quadruple therapy might be regarded as a promising alternative to bismuth-containing quadruple therapy in H. pylori eradication.",2020,Symptom improvement rates were 96.1% and 97.0% for IDFA and IDFB (P = 1).,"['Two hundred twenty H. pylori-infected patients', 'Helicobacter pylori infection']","['doxycycline', 'Allicin-containing quadruple therapy', 'allicin-containing quadruple therapy and bismuth-containing quadruple therapy', '14-day quadruple therapy: ilaprazole', 'furazolidone', 'allicin soft capsule (40 mg of DATS tid) (IDFA) or colloidal bismuth tartrate', 'allicin-containing quadruple therapy vs. bismuth-containing quadruple therapy']","['efficacy, safety and tolerability', 'Symptom improvement rates', 'Symptom improvement, adverse events, and adherence', 'Nausea', 'adverse event rates', 'H. pylori eradication rates', 'eradication rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0051200', 'cui_str': 'allicin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C1273639', 'cui_str': 'Soft capsule'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0053781', 'cui_str': 'bismoverol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",220.0,0.0405258,Symptom improvement rates were 96.1% and 97.0% for IDFA and IDFB (P = 1).,"[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, the Third Xiangya Hospital of Central South University, Changsha, Hunan Province, People's Republic of China.""}, {'ForeName': 'Xiu-Juan', 'Initials': 'XJ', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Lin-Fang', 'Initials': 'LF', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jing-Shu', 'Initials': 'JS', 'LastName': 'Chi', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'De-Lin', 'Initials': 'DL', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Kai-Xiao', 'Initials': 'KX', 'LastName': 'Kun', 'Affiliation': ''}, {'ForeName': 'Ren-Jie', 'Initials': 'RJ', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Can-Xia', 'Initials': 'CX', 'LastName': 'Xu', 'Affiliation': ''}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001896']
1948,32804929,Cardiac and renal function interactions in heart failure with reduced ejection fraction: A mathematical modeling analysis.,"Congestive heart failure is characterized by suppressed cardiac output and arterial filling pressure, leading to renal retention of salt and water, contributing to further volume overload. Mathematical modeling provides a means to investigate the integrated function and dysfunction of heart and kidney in heart failure. This study updates our previously reported integrated model of cardiac and renal functions to account for the fluid exchange between the blood and interstitium across the capillary membrane, allowing the simulation of edema. A state of heart failure with reduced ejection fraction (HF-rEF) was then produced by altering cardiac parameters reflecting cardiac injury and cardiovascular disease, including heart contractility, myocyte hypertrophy, arterial stiffness, and systemic resistance. After matching baseline characteristics of the SOLVD clinical study, parameters governing rates of cardiac remodeling were calibrated to describe the progression of cardiac hemodynamic variables observed over one year in the placebo arm of the SOLVD clinical study. The model was then validated by reproducing improvements in cardiac function in the enalapril arm of SOLVD. The model was then applied to prospectively predict the response to the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin, which has been shown to reduce heart failure events in HF-rEF patients in the recent DAPAHF clinical trial by incompletely understood mechanisms. The simulations predict that dapagliflozin slows cardiac remodeling by reducing preload on the heart, and relieves congestion by clearing interstitial fluid without excessively reducing blood volume. This provides a quantitative mechanistic explanation for the observed benefits of SGLT2i in HF-rEF. The model also provides a tool for further investigation of heart failure drug therapies.",2020,"The model was then applied to prospectively predict the response to the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin, which has been shown to reduce heart failure events in HF-rEF patients in the recent DAPAHF clinical trial by incompletely understood mechanisms.","['heart failure with reduced ejection fraction', 'heart failure']","['reduced ejection fraction (HF-rEF', 'dapagliflozin', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin']","['cardiac function', 'heart contractility, myocyte hypertrophy, arterial stiffness, and systemic resistance']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C1258017', 'cui_str': 'Heart Contractility'}, {'cui': 'C0596981', 'cui_str': 'Myocytes'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0281883,"The model was then applied to prospectively predict the response to the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin, which has been shown to reduce heart failure events in HF-rEF patients in the recent DAPAHF clinical trial by incompletely understood mechanisms.","[{'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, United States of America.'}, {'ForeName': 'Sanchita', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, United States of America.'}, {'ForeName': 'K Melissa', 'Initials': 'KM', 'LastName': 'Hallow', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, United States of America.'}]",PLoS computational biology,['10.1371/journal.pcbi.1008074']
1949,32808484,Is Dietary Non-Adherence unique to obesity and weight loss? Results from a randomized clinical trial.,,2020,"However, total percent adherence did not differ between groups (p=0.60) and hunger scores did not change across groups over time (p=0.08).
","['between lean and two groups of individuals with obesity', '23males; age 48±14), lean participants (n=23; BMI 23±2 kg/m 2  ) received a', 'and participants with obesity (BMI 36±7']","['outpatient dietary intervention', 'weight maintaining diet (WMEN', 'WMEN (n=18) or 35% calorie reduced (CR) diet']","['hunger scores', 'total percent adherence', 'dietary adherence', 'Weight', 'dietary adherence and perceived hunger']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0597085,"However, total percent adherence did not differ between groups (p=0.60) and hunger scores did not change across groups over time (p=0.08).
","[{'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Stinson', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Votruba', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Venti', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lovato-Morales', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Marci E', 'Initials': 'ME', 'LastName': 'Gluck', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23008']
1950,32810697,A comparison of young children's spatiotemporal measures of walking and running in three common types of footwear compared to bare feet.,"BACKGROUND


Clinicians and footwear manufacturers often advise young children to wear soft-soled footwear when they are first learning to walk. There is limited evidence as to why this advice is given, and if soft-soled shoes are as close to barefoot as thought.
RESEARCH QUESTION


What are the differences in spatiotemporal measures of gait during walking and running in three common types of children's footwear with a soft-soled compared to barefoot in young children?
METHODS


The study used a quasi-experimental design, with the condition order randomised using a Latin square sequence. Forty-seven children were recruited (2 - 4 years). Participants walked or ran the length of a GAITrite mat in a randomized order for barefoot and soft-soled sneaker, boot and sandal conditions. Linear regression analyses were used to investigate the main effect of each soft-soled footwear compared to bare feet in the different gait parameters.
RESULTS


For walking and running trials, cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition. While wearing sneakers and sandals increased the stance percentage for walking and running trials, compared to barefoot, this difference was only apparent during the running trial for the boots. Likewise, although double support time increased for both the boots and sneakers in walking and running, compared to barefoot, this difference was only observed in the sandals during walking.
SIGNIFICANCE


This research found that various types of soft-soled footwear impacted gait compared to the barefoot condition, with some differences seen between walking and running trials. These findings challenge the assumption that soft-soled footwear facilitate a similar gait to barefoot walking and running, although the clinical significance of these differences is unknown.",2020,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.",['Forty-seven children were recruited (2 - 4\u202fyears'],[],['step time and stride length'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",47.0,0.0330217,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cranage', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia. Electronic address: simone.cranage@monash.edu.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Perraton', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kelly-Ann', 'Initials': 'KA', 'LastName': 'Bowles', 'Affiliation': 'Department of Paramedicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cylie', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.147']
1951,32811480,A realist evaluation approach to explaining the role of context in the impact of a complex eHealth intervention for improving prevention of cardiovascular disease.,"BACKGROUND


Reduction of cardiovascular disease (CVD) is a worldwide health priority and innovative uses of technology-based interventions may assist patients with improving prevention behaviours. Targeting these interventions to recipients most likely to benefit requires understanding how contexts of use influence responsiveness to the intervention, and how this interaction favours or discourages health behaviour. Using a realist evaluation approach, the aim of this study was to examine the contextual factors influencing behaviour change within a multi-feature eHealth intervention with personalised data integration from the primary care electronic health record (EHR).
METHODS


Realist evaluation of qualitative data from the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised trial (N = 934). Thirty-six participants from the intervention group (N = 486) who had completed 12 months of study follow-up were interviewed. Coding of transcripts was structured around configurations of contexts, mechanisms, and outcomes of intervention use. Contextual narratives were derived from thematic analysis of the interviews.
RESULTS


Mechanisms favouring positive health behaviour occurred when participants responded to four interactive features of the intervention. Facilitating mechanisms included greater cognitive engagement whereby participants perceived value and benefit, and felt motivated, confident and incentivised. Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention. Increased personalisation occurred when modifiable CVD risk factors became relatable to lifestyle behaviour; and experiences of feeling greater agency/self-efficacy emerged. Use and non-use of the intervention were influenced by four overarching narratives within the individual's micro-level and meso-level environments: illness experiences; receptiveness to risk and prevention information; history of the doctor-patient relationship; and relationship with technology.
CONCLUSIONS


Intervention-context interactions are central to understanding how change mechanisms activate within complex interventions to exert their impact on recipients. Intervention use and non-use were context-dependent, underscoring the need for further research to target eHealth innovations to those most likely to benefit.",2020,Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention.,"['Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention', 'Thirty-six participants from the intervention group (N\u2009=\u2009486) who had completed 12\u2009months of study follow-up were interviewed']",['complex eHealth intervention'],['positive health behaviour'],"[{'cui': 'C1269909', 'cui_str': 'MOVED FROM'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",36.0,0.0727726,Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention.,"[{'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Coorey', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia. gcoorey@georgeinstitute.org.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peiris', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Neubeck', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia.'}]",BMC health services research,['10.1186/s12913-020-05597-5']
1952,32813780,Learning musculoskeletal anatomy through new technologies: a randomized clinical trial.,"OBJECTIVE


to investigate the influence of the application of new methodologies on learning and the motivation of students of the Anatomy discipline.
METHOD


randomized, longitudinal, prospective, intervention study. Sixty-two students were recruited to assess the impact of different methodologies. The sample was randomized to compare the results of teaching with a 3D atlas, ultrasound and the traditional method. The parameters were assessed through a satisfaction evaluation questionnaire and anatomical charts. Repeated measures ANOVA was used to determine statistical significance.
RESULTS


in terms of the usefulness of the seminars, 98.1% of the students considered them to be very positive or positive, stating that they had stimulated their interest in anatomy. The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040). In general, the students improved their grades by around 20%.
CONCLUSION


the traditional method combined with new technologies increases the interest of students in human anatomy and enables them to acquire skills and competencies during the learning process.",2020,The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040).,['Sixty-two students'],[],[],"[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],62.0,0.0349984,The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040).,"[{'ForeName': 'Elena Sonsoles', 'Initials': 'ES', 'LastName': 'Rodríguez-López', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Sofía Olivia', 'Initials': 'SO', 'LastName': 'Calvo-Moreno', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Eduardo Cimadevilla', 'Initials': 'EC', 'LastName': 'Fernández-Pola', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Guodemar-Pérez', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Ruiz-López', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3237.3281']
1953,32824214,Estimated Intakes of Nutrients and Polyphenols in Participants Completing the MaPLE Randomised Controlled Trial and Its Relevance for the Future Development of Dietary Guidelines for the Older Subjects.,"The evaluation of food intake in older subjects is crucial in order to be able to verify adherence to nutritional recommendations. In this context, estimation of the intake of specific dietary bioactives, such as polyphenols, although particularly challenging, is necessary to plan possible intervention strategies to increase their intake. The aims of the present study were to: (i) evaluate the nutritional composition of dietary menus provided in a residential care setting; (ii) estimate the actual intake of nutrients and polyphenols in a group of older subjects participating in the MaPLE study; and (iii) investigate the impact of an eight-week polyphenol-rich dietary pattern, compared to an eight-week control diet, on overall nutrient and polyphenol intake in older participants. The menus served to the participants provided ~770 mg per day of total polyphenols on average with small variations between seasons. The analysis of real consumption, measured using weighed food diaries, demonstrated a lower nutrient (~20%) and polyphenol intake (~15%) compared to that provided by the menus. The feasibility of dietary patterns that enable an increase in polyphenol intake with putative health benefits for age-related conditions is discussed, with a perspective to developing dietary guidelines for this target population.",2020,The menus served to the participants provided ~770 mg per day of total polyphenols on average with small variations between seasons.,"['older subjects', 'older participants', 'Participants', 'older subjects participating in the MaPLE study; and (iii', 'Older Subjects']","['polyphenol-rich dietary pattern, compared to an eight-week control diet, on overall nutrient and polyphenol intake', 'nutrients and polyphenols']","['polyphenol intake', 'Estimated Intakes of Nutrients and Polyphenols']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0330996', 'cui_str': 'Genus Acer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",,0.0158559,The menus served to the participants provided ~770 mg per day of total polyphenols on average with small variations between seasons.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Martini', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bernardi', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': ""Del Bo'"", 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hidalgo Liberona', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Zamora-Ros', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': ""Geriatria, Accettazione Geriatrica e Centro di ricerca per l'invecchiamento, IRCCS INRCA, 60127 Ancona, Italy.""}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Porrini', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gargari', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'González-Domínguez', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Peron', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kirkup', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich NR4 7UG, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich NR4 7UG, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andres-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guglielmetti', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Riso', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}]",Nutrients,['10.3390/nu12082458']
1954,32824387,A Traditional Korean Diet with a Low Dietary Inflammatory Index Increases Anti-Inflammatory IL-10 and Decreases Pro-Inflammatory NF-κB in a Small Dietary Intervention Study.,"Chronic low-grade inflammation may increase the risk of chronic disease, while diets rich in anti-inflammatory components may reduce it. To determine the anti-inflammatory properties of the traditional Korean diet (K-diet) that comprises high amounts of vegetables, fiber and phytochemicals, moderate amounts of legumes, and low amounts of animal fat, ten obese women aged 50-60 years were randomly assigned to the K-diet or control diet group. The control diet was a Westernized Korean diet commonly consumed in Korea, which is high in animal fat and protein. Subjects were housed in metabolic unit-like conditions during the 2-week intervention. Plasma was collected before and after the intervention to measure inflammatory cytokines using ELISA. The dietary inflammatory index (DII) was calculated based on nutrients and food intake. The DII score for the K-diet was lower than that of the control diet (-0.94 ± 1.39 vs. 1.04 ± 1.61,  p  < 0.001). In the K-diet group, anti-inflammatory interleukin (IL)-10 levels increased (4.45 ± 0.34 pg/mL vs. 5.94 ± 0.33 pg/mL,  p  = 0.0102), whereas pro-inflammatory nuclear factor kappa B (NF-κB) levels decreased (7.70 ± 0.62 pg/mL vs. 2.71 ± 0.49 pg/mL,  p  = 0.0015), but not in the control group. In the K-diet group, NF-κB levels negatively correlated with IL-10 levels (r = -0.794,  p  = 0.006). The K-diet has anti-inflammatory properties, and IL-10 and NF-κB are putative inflammatory markers for K-diet studies.",2020,"In the K-diet group, anti-inflammatory interleukin (IL)-10 levels increased (4.45 ± 0.34 pg/mL vs. 5.94 ± 0.33 pg/mL,  p  = 0.0102), whereas pro-inflammatory nuclear factor kappa B (NF-κB) levels decreased (7.70 ± 0.62 pg/mL vs. 2.71 ± 0.49 pg/mL,  p  = 0.0015), but not in the control group.",['ten obese women aged 50-60 years'],"['K-diet or control diet group', 'traditional Korean diet (K-diet']","['DII score for the K-diet', 'IL-10 levels', 'NF-κB levels', 'Plasma', 'anti-inflammatory interleukin (IL)-10 levels', 'dietary inflammatory index (DII', 'pro-inflammatory nuclear factor kappa B (NF-κB) levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}]",10.0,0.0199436,"In the K-diet group, anti-inflammatory interleukin (IL)-10 levels increased (4.45 ± 0.34 pg/mL vs. 5.94 ± 0.33 pg/mL,  p  = 0.0102), whereas pro-inflammatory nuclear factor kappa B (NF-κB) levels decreased (7.70 ± 0.62 pg/mL vs. 2.71 ± 0.49 pg/mL,  p  = 0.0015), but not in the control group.","[{'ForeName': 'Phil-Kyung', 'Initials': 'PK', 'LastName': 'Shin', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Seon-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Myung Sunny', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'KyongChol', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'GangNam Major Hospital, Seoul 06279, Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Sang-Woon', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}]",Nutrients,['10.3390/nu12082468']
1955,32824392,"The Role of Primary Tumor Resection in Colorectal Cancer Patients with Asymptomatic, Synchronous, Unresectable Metastasis: A Multicenter Randomized Controlled Trial.","We aimed to assess the survival benefits of primary tumor resection (PTR) followed by chemotherapy in patients with asymptomatic stage IV colorectal cancer with asymptomatic, synchronous, unresectable metastases compared to those of upfront chemotherapy alone. This was an open-label, prospective, randomized controlled trial (ClnicalTrials.gov Identifier: NCT01978249). From May 2013 to April 2016, 48 patients (PTR,  n  = 26; upfront chemotherapy,  n  = 22) diagnosed with asymptomatic colorectal cancer with unresectable metastases in 12 tertiary hospitals were randomized (1:1). The primary endpoint was two-year overall survival. The secondary endpoints were primary tumor-related complications, PTR-related complications, and rate of conversion to resectable status. The two-year cancer-specific survival was significantly higher in the PTR group than in the upfront chemotherapy group (72.3% vs. 47.1%;  p  = 0.049). However, the two-year overall survival rate was not significantly different between the PTR and upfront chemotherapy groups (69.5% vs. 44.8%,  p  = 0.058). The primary tumor-related complication rate was 22.7%. The PTR-related complication rate was 19.2%, with a major complication rate of 3.8%. The rates of conversion to resectable status were 15.3% and 18.2% in the PTR and upfront chemotherapy groups. While PTR followed by chemotherapy resulted in better two-year cancer-specific survival than upfront chemotherapy, the improvement in the two-year overall survival was not significant.",2020,The two-year cancer-specific survival was significantly higher in the PTR group than in the upfront chemotherapy group (72.3% vs. 47.1%;  p  = 0.049).,"['Colorectal Cancer Patients with Asymptomatic, Synchronous, Unresectable Metastasis', '48 patients (PTR,  n  = 26; upfront chemotherapy,  n  = 22) diagnosed with asymptomatic colorectal cancer with unresectable metastases in 12 tertiary hospitals', 'patients with asymptomatic stage IV colorectal cancer with asymptomatic, synchronous, unresectable metastases']","['PTR', 'primary tumor resection (PTR) followed by chemotherapy']","['cancer-specific survival', 'primary tumor-related complications, PTR-related complications, and rate of conversion to resectable status', 'year cancer-specific survival', 'overall survival rate', 'overall survival', 'survival benefits', 'year overall survival', 'complication rate', 'PTR-related complication rate', 'rates of conversion to resectable status']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0677950', 'cui_str': 'Colorectal cancer stage IV'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.232137,The two-year cancer-specific survival was significantly higher in the PTR group than in the upfront chemotherapy group (72.3% vs. 47.1%;  p  = 0.049).,"[{'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Division of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Jeong-Heum', 'Initials': 'JH', 'LastName': 'Baek', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon 21565, Korea.'}, {'ForeName': 'Gyu-Seog', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Colorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu 41404, Korea.'}, {'ForeName': 'Won Cheol', 'Initials': 'WC', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Wonkwang University School of Medicine, Iksan 54538, Korea.'}, {'ForeName': 'Chang Sik', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Sung-Bum', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam 13620, Korea.'}, {'ForeName': 'Byung Soh', 'Initials': 'BS', 'LastName': 'Min', 'Affiliation': 'Division of Colon and Rectal Surgery, Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Jae Hwang', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yeungnam University College of Medicine, Daegu 42415, Korea.'}, {'ForeName': 'Hyeong Rok', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun 58128, Korea.'}, {'ForeName': 'Bong Hwa', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Hallym University Sacred Heart Hospital, Anyang 14068, Korea.'}, {'ForeName': 'Jae Hwan', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang 10408, Korea.'}, {'ForeName': 'Seung-Yong', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Seung Hyuk', 'Initials': 'SH', 'LastName': 'Baik', 'Affiliation': 'Division of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}]",Cancers,['10.3390/cancers12082306']
1956,32824394,"Effects of Virtual Reality versus Exercise on Pain, Functional, Somatosensory and Psychosocial Outcomes in Patients with Non-specific Chronic Neck Pain: A Randomized Clinical Trial.","Background : Virtual reality (VR) applied to patients with neck pain is a promising intervention to produce positive effects when used alone or combined with exercise. Therefore, the objective of this manuscript is to compare the effects of VR versus exercise treatment on pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes in patients with non-specific chronic neck pain (NS-CNP).  Methods : A single-blinded, randomized clinical trial was carried out. A total sample of 44 patients with NS-CNP was randomized into a VR treatment group or neck exercises group. The intervention consisted of two treatment sessions per week, for four weeks and eight sessions. Four measurement moments (at baseline, immediately, 1 month, and 3 months after intervention) were considered. Pain intensity, CPM, TS, functional and somatosensory outcomes were measured.  Results : Statistically significant differences were revealed for time factor (F = 16.40,  p  < 0.01, η p 2  = 0.28) and group*time interaction for kinesiophobia (F = 3.89,  p  = 0.01, η p 2  = 0.08) showing post-hoc differences in favor of the VR group at 3 months ( p  < 0.05, d = 0.65). Significant effects were shown for time factor ( p  < 0.05) but not for the group*time interaction ( p  > 0.05) for pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety. Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  Conclusions : Kinesiophobia was the only outcome that showed differences between VR and exercise at 3 months. Nevertheless, pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety did not show differences between both interventions.",2020,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","['Patients with Non-specific Chronic Neck Pain', 'patients with non-specific chronic neck pain (NS-CNP', '44 patients with NS-CNP', 'patients with neck pain']","[' ', 'Kinesiophobia', 'Virtual Reality versus Exercise', 'Virtual reality (VR', 'VR treatment group or neck exercises group', 'VR versus exercise']","['CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM', 'pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety', 'pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety', 'time factor', 'group*time interaction for kinesiophobia', 'pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes', 'Pain intensity, CPM, TS, functional and somatosensory outcomes', 'Pain, Functional, Somatosensory and Psychosocial Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",44.0,0.113865,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","[{'ForeName': 'David Morales', 'Initials': 'DM', 'LastName': 'Tejera', 'Affiliation': 'Escuela Internacional de Doctorado, Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, 28032 Alcorcón, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Beltran-Alacreu', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine. Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Leon Hernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid 28008, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Gil-Martínez', 'Affiliation': 'CranioSpain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'CranioSpain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17165950']
1957,32824920,Can Creatine Supplementation Interfere with Muscle Strength and Fatigue in Brazilian National Level Paralympic Powerlifting?,"The aim of the present study was to analyze the effect of creatine (Cr) supplementation on peak torque (PT) and fatigue rate in Paralympic weightlifting athletes. Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg. The measurements of muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time) were determined by a Musclelab load cell. The study was performed in a single-blind manner, with subjects conducting the experiments first with placebo supplementation and then, following a 7-day washout period, beginning the same protocol with creatine supplementation for 7 days. This sequence was chosen because of the lengthy washout of creatine. Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05). However, when comparing the results of the moments with the use of Cr and placebo, a difference was observed for the FI after seven days (U 3 : 1.12; 95% CI: (0.03, 2.27);  p  = 0.02); therefore, the FI was higher for placebo. Creatine supplementation has a positive effect on the performance of Paralympic powerlifting athletes, reducing fatigue index, and keeping the force levels as well as PT.",2020,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","['Paralympic weightlifting athletes', 'Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg']","['placebo', 'Creatine supplementation', 'creatine (Cr) supplementation', 'placebo supplementation']","['muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time', 'muscle force, peak torque, RFD, and time to maximum isometric force', 'peak torque (PT) and fatigue rate']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.0998311,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","[{'ForeName': 'Carlos Rodrigo', 'Initials': 'CR', 'LastName': 'Soares Freitas Sampaio', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Felipe J', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Alexandre R P', 'Initials': 'ARP', 'LastName': 'Ferreira', 'Affiliation': 'College of Physical Education and Exercise Science, University of Brasília (UnB), Brasília 70910-900, Brazil.'}, {'ForeName': 'Jymmys Lopes Dos', 'Initials': 'JLD', 'LastName': 'Santos', 'Affiliation': 'Program in Biotechnology, Northeast Network in Biotechnology (RENORBIO), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Anderson Carlos', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Dihogo Gama de', 'Initials': 'DG', 'LastName': 'Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Raphael Fabrício de', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Osvaldo Costa', 'Initials': 'OC', 'LastName': 'Moreira', 'Affiliation': 'Institute of Biological Sciences and Health, Federal University of Viçosa, Campus Florestal, Minas Gerais 35690-000, Brazil.'}, {'ForeName': 'Ialuska', 'Initials': 'I', 'LastName': 'Guerra', 'Affiliation': 'Federal Institute of Education, Science and Technology of Ceará (IFCE), Campus of Juazeiro do Norte, Ceará 63040-540, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernandes Filho', 'Affiliation': 'Brazilian Paralympic Academy, Brazilian Paralympic Committee, São Paulo 04329-000, SP, Brazil.'}, {'ForeName': 'Lucas Soares', 'Initials': 'LS', 'LastName': 'Marcucci-Barbosa', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Albená', 'Initials': 'A', 'LastName': 'Nunes-Silva', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Paulo Francisco de', 'Initials': 'PF', 'LastName': 'Almeida-Neto', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Breno Guilherme Araújo Tinoco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Victor Machado', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Trásos Montes and Alto Douro University, 5001-801 Vila Real, Portugal.'}]",Nutrients,['10.3390/nu12092492']
1958,32824994,Exploring Perceptions of Internet-Delivered Cognitive Behaviour Therapy among Public Safety Personnel: Informing Dissemination Efforts.,"Background  Public safety personnel (PSP) experience high rates of mental health disorders but have limited access to treatment. To improve treatment access, there is a growing interest in offering internet-delivered cognitive behaviour therapy (ICBT) to PSP. As attitudes towards ICBT can both impact and inform ICBT implementation efforts, this study examines perceptions of ICBT among PSP who viewed a poster (a commonly used method of advertising ICBT) or a poster supplemented with a story of a PSP who benefitted from ICBT.  Methods  Participants ( N  = 132) from various PSP sectors were randomly assigned to view a poster or a poster and a story. Participants then completed an online survey assessing their perceptions of ICBT using both qualitative and quantitative questions. We used a mixed-methods approach to analyze the data.  Results  No differences in perceptions of ICBT were identified between the conditions. Ratings of credibility, treatment expectancy, anticipated treatment adherence, and acceptability suggested that PSP had positive perceptions of ICBT. Most participants (93%) reported that they would access ICBT if they needed help with mental health concerns. Participants ranked therapist-guided ICBT as their second most preferred treatment, with psychologists ranked first. Female participants found ICBT more credible than male participants. More experienced PSP reported lower acceptability and anticipated adherence to ICBT.  Conclusions  The findings suggest that many PSP are likely to be receptive to ICBT even when a simple poster is used as a method of informing PSP of this treatment option. Further attention to improving the perceptions of ICBT among certain groups may be warranted.",2020,No differences in perceptions of ICBT were identified between the conditions.,"['Female participants found ICBT more credible than male participants', 'Methods  Participants ( N  = 132) from various PSP sectors']",['Internet-Delivered Cognitive Behaviour Therapy'],"['Ratings of credibility, treatment expectancy', 'perceptions of ICBT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0686862,No differences in perceptions of ICBT were identified between the conditions.,"[{'ForeName': 'Hugh C', 'Initials': 'HC', 'LastName': 'McCall', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Angelo P', 'Initials': 'AP', 'LastName': 'Sison', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Jody L', 'Initials': 'JL', 'LastName': 'Burnett', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Janine D', 'Initials': 'JD', 'LastName': 'Beahm', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Hadjistavropoulos', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17176026']
1959,32825020,"Comparative Indoor Pollution from Glo, Iqos, and Juul, Using Traditional Combustion Cigarettes as Benchmark: Evidence from the Randomized SUR-VAPES AIR Trial.","Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) are appealing alternatives to combustion cigarettes. Limited between- and within-device comparative data are available on MRP. We aimed at comparing indoor particulate matter (PM) emissions measured in a randomized trial enforcing standardized smoking sessions, testing different devices and flavors of MRP, using traditional combustion cigarettes (TCC) as benchmark. Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP < 100 μg/m 3 , and for TCC > 1000 μg/m 3 ). Despite this, significant differences among MRP were found, with Iqos appearing associated with a significantly lower burden of emissions for all the monitored fractions of PM, including total PM (all  p  < 0.05). Precisely, during use, PM ≤1 µm (PM 1 ) emissions were 28 (16; 28) μg/m 3  for Glo, 25 (15; 57) μg/m 3  for Iqos, and 73 (15; 559) μg/m 3  for Juul ( p  < 0.001 for Glo vs. Iqos,  p  < 0.001 for Glo vs. Juul, and  p  = 0.045 for Iqos vs. Juul). Exploratory within-MRP analyses suggested significant differences between flavors, favoring, for instance, Ultramarine for Glo, Bronze for Iqos, and Mango for Juul, even if results varied substantially according to individual smoker. In conclusion, leading MRP have significantly less intense and persistent effects on indoor pollution in comparison to TCC. Yet, when focusing solely on MRP, between-product and between-flavor differences appear, with quantitative estimates suggesting lower polluting effects with Iqos. These results, if confirmed externally, could be used to individualize product and flavor choice to minimize the untoward effects of EVC and HNBC on indoor pollution.",2020,"Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP",[],"['MRP', 'traditional combustion cigarettes (TCC', 'indoor particulate matter (PM) emissions', 'TCC', 'Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC']","['burden of emissions', 'total PM']",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0077072', 'cui_str': 'triclocarban'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0455956', 'cui_str': 'Cigarette burn'}]","[{'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0436517,"Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Peruzzi', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Frati', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carnevale', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Miraldi', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Viale Del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Sciarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Versaci', 'Affiliation': 'UOC UTIC Emodinamica e Cardiologia, Ospedale Santa Maria Goretti, Via Antonio Canova, 04100 Latina, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Cammalleri', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Avino', 'Affiliation': 'Department of Agricultural, Environmental and Food Sciences (DiAAA), University of Molise, via De Sanctis, 86100 Campobasso, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Protano', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vitali', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17176029']
1960,32721580,Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.,"Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection. 1 , 2  In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19. 3  In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported. 4 , 5  In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n = 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0). 6  Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients.",2020,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"['adults admitted to hospital with severe COVID-19 (n\xa0= 237', 'healthy volunteers and patients with COVID-19', 'recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0', 'patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection']",['placebo'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0311468', 'cui_str': 'Increased bilirubin level'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.110012,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Montastruc', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France. Electronic address: francois.montastruc@univ-tlse3.fr.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Thuriot', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Durrieu', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.050']
1961,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and Design of a Cluster-Randomized Trial.,"BACKGROUND


The Systolic Blood Pressure Intervention Trial (SPRINT) reported intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS


Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi. FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0 mmHg difference in systolic BP at a 0.05 significance level and 80% follow-up rate.
CONCLUSIONS


IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the US.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
1962,32827483,"Low-cost oral metronomic chemotherapy versus intravenous cisplatin in patients with recurrent, metastatic, inoperable head and neck carcinoma: an open-label, parallel-group, non-inferiority, randomised, phase 3 trial.","BACKGROUND


Regimens for palliation in patients with head and neck cancer recommended by the US National Comprehensive Cancer Network (NCCN) have low applicability (less than 1-3%) in low-income and middle-income countries (LMICs) because of their cost. In a previous phase 2 study, patients with head and neck cancer who received metronomic chemotherapy had better outcomes when compared with those who received intravenous cisplatin, which is commonly used as the standard of care in LMICs. We aimed to do a phase 3 study to substantiate these findings.
METHODS


We did an open-label, parallel-group, non-inferiority, randomised, phase 3 trial at the Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India. We enrolled adult patients (aged 18-70 years) who planned to receive palliative systemic treatment for relapsed, recurrent, or newly diagnosed squamous cell carcinoma of the head and neck, and who had an Eastern Cooperative Oncology Group performance status score of 0-1 and measurable disease, as defined by the Response Evaluation Criteria In Solid Tumors. We randomly assigned (1:1) participants to receive either oral metronomic chemotherapy, consisting of 15 mg/m 2  methotrexate once per week plus 200 mg celecoxib twice per day until disease progression or until the development of intolerable side-effects, or 75 mg/m 2  intravenous cisplatin once every 3 weeks for six cycles. Randomisation was done by use of a computer-generated randomisation sequence, with a block size of four, and patients were stratified by primary tumour site and previous cancer-directed treatment. The primary endpoint was median overall survival. Assuming that 6-month overall survival in the intravenous cisplatin group would be 40%, a non-inferiority margin of 13% was defined. Both intention-to-treat and per-protocol analyses were done. All patients who completed at least one cycle of the assigned treatment were included in the safety analysis. This trial is registered with the Clinical Trials Registry-India, CTRI/2015/11/006388, and is completed.
FINDINGS


Between May 16, 2016, and Jan 17, 2020, 422 patients were randomly assigned: 213 to the oral metronomic chemotherapy group and 209 to the intravenous cisplatin group. All 422 patients were included in the intention-to-treat analysis, and 418 patients (211 in the oral metronomic chemotherapy group and 207 in the intravenous cisplatin group) were included in the per-protocol analysis. At a median follow-up of 15·73 months, median overall survival in the intention-to-treat analysis population was 7·5 months (IQR 4·6-12·6) in the oral metronomic chemotherapy group compared with 6·1 months (3·2-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·773 [95% CI 0·615-0·97, p=0·026]). In the per-protocol analysis population, median overall survival was 7·5 months (4·7-12·8) in the oral metronomic chemotherapy group and 6·1 months (3·4-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·775 [95% CI 0·616-0·974, p=0·029]). Grade 3 or higher adverse events were observed in 37 (19%) of 196 patients in the oral metronomic chemotherapy group versus 61 (30%) of 202 patients in the intravenous cisplatin group (p=0·01).
INTERPRETATION


Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events. It therefore represents a new alternative standard of care if current NCCN-approved options for palliative therapy are not feasible.
FUNDING


Tata Memorial Center Research Administration Council.
TRANSLATIONS


For the Hindi, Marathi, Gujarati, Kannada, Malayalam, Telugu, Oriya, Bengali, and Punjabi translations of the abstract see Supplementary Materials section.",2020,"INTERPRETATION


Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events.","['patients with recurrent, metastatic, inoperable head and neck carcinoma', 'All 422 patients were included in the intention-to-treat analysis, and 418 patients (211 in the oral metronomic chemotherapy group and 207 in the intravenous cisplatin group) were included in the per-protocol analysis', 'Between May 16, 2016, and Jan 17, 2020, 422 patients were randomly assigned: 213 to the', 'patients with head and neck cancer', 'enrolled adult patients (aged 18-70 years) who planned to receive palliative systemic treatment for relapsed, recurrent, or newly diagnosed squamous cell carcinoma of the head and neck, and who had an Eastern Cooperative Oncology Group performance status score of 0-1 and measurable disease, as defined by the Response Evaluation Criteria In Solid Tumors', 'patients with head and neck cancer who received']","['intravenous cisplatin', 'oral metronomic chemotherapy, consisting of 15 mg/m 2  methotrexate', 'oral metronomic chemotherapy', 'metronomic chemotherapy', 'cisplatin', 'celecoxib', 'Low-cost oral metronomic chemotherapy']","['Grade 3 or higher adverse events', 'overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",422.0,0.319059,"INTERPRETATION


Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events.","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sachin Babanrao', 'Initials': 'SB', 'LastName': 'Dhumal', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Section of Biostatistics, Centre for Cancer Epidemiology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Suyash', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Suman Kumar', 'Initials': 'SK', 'LastName': 'Ankathi', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Sable', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nawale', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Bhelekar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Mukadam', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Chandrasekharan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Vallathol', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Hollis', 'Initials': 'H', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Satvik', 'Initials': 'S', 'LastName': 'Khaddar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Narmadha', 'Initials': 'N', 'LastName': 'Rathnasamy', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Ramnath', 'Initials': 'R', 'LastName': 'Shenoy', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Lakhan', 'Initials': 'L', 'LastName': 'Kashyap', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Rahul Kumar', 'Initials': 'RK', 'LastName': 'Rai', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Abraham', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Saswata', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Swaratika', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karuvandan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Vijai', 'Initials': 'V', 'LastName': 'Simha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Vasu', 'Initials': 'V', 'LastName': 'Babu', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Prahalad', 'Initials': 'P', 'LastName': 'Elamarthi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Annu', 'Initials': 'A', 'LastName': 'Rajpurohit', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kanteti Aditya Pavan', 'Initials': 'KAP', 'LastName': 'Kumar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Srikanth', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Ravind', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Shripad', 'Initials': 'S', 'LastName': 'Banavali', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India. Electronic address: id-kumarprabhashtmh@gmail.com.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30275-8']
1963,32827501,Intranasal vasopressin expedites dishonesty in females.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in males and females. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP. The dishonest behavior of females treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in females, contingent on the motivation of dishonesty. Our findings provide insight into sex-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
1964,32827598,Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: a randomized controlled trial: Effectiveness of a parental-oriented mobile text messages to early childhood caries control.,"OBJECTIVES


To evaluate the effectiveness of educational messages as an aid in the control of early childhood caries (ECC) in low socioeconomic children.
METHODS


A single-blinded, randomized, and parallel-group study was conducted with 104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded). The participants were randomly allocated into control and intervention groups (1:1), stratified by eHealth literacy scores (eHEALS) of parents and caries experience of children. Each 2 weeks, text messages were sent to parents of intervention group via WhatsApp. Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS) were assessed at baseline, 3- and 6-month follow-up, while eHEALS and dietary habits were determined at baseline and 6-month follow-up. Statistical analysis was performed to intra and intergroup comparisons through Fischer´s exact and McNemar tests, and Mann-Whitney U and Friedman tests, respectively (P < 0.05).
RESULTS


Despite similarities between groups, intervention increased parental eHEALS scores, influenced the reports about the children's consumption of sugar-free sweets and controlled the severity of ECC.
CONCLUSION


Therefore, mobile text messages were effective to control the severity of ECC in low socioeconomic preschoolers, improving parental eHealth literacy and changing children's dietary patterns.
CLINICAL SIGNIFICANCE


These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.",2020,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"['low socioeconomic children', '104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded']","['educational messages', 'parental-oriented mobile text messages', 'Parental-oriented educational mobile messages']","['Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS', 'parental eHEALS scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0747732,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lotto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Strieder', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Patricia Estefania', 'Initials': 'PE', 'LastName': 'Ayala Aguirre', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thais Marchini', 'Initials': 'TM', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'de Andrade Moreira Machado', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil. Electronic address: thiagocruvinel@fob.usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103456']
1965,32827645,Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low- to Middle-Income Countries: A Phase II Non-Inferiority Randomized Controlled Study.,"BACKGROUND


Minimal access surgery [MAS] is not available to most people in the rural areas of Low Middle-Income Countries [LMIC]. This leads to an increase in the morbidity and the economic loss to the poor and the marginalized. The Gasless laparoscopic surgeries [GAL] are possible in rural areas as they could be carried out under spinal-anaesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anaesthesia. The current study compares GAL with conventional Laparoscopic surgeries [COL] for general surgical procedures METHODS: A single-centre, non-blinded randomized control trial [RCT] was conducted to evaluate non - inferiority of GAL versus COL at a teaching hospital in New Delhi. Patients were allocated into two groups and underwent MAS (Cholecystectomies and appendectomies). The procedure was carried out by two surgeons by randomly choosing between GAL and COL. The data was collected by postgraduates and analyzed by a biostatistician.
RESULTS


100 patients who met the inclusion criteria were allocated into two groups. No significant difference was observed in the mean operating time between GAL group (52.9 min) vs COL group (55 minutes) [p=0.3]. The intraoperative vital signs were better in the GAL group [p < 0.05]. The postoperative pain score was slightly higher in the GAL group [p = 0.01]; however, it did not require additional analgesics.
CONCLUSIONS


No significant differences were found between the two groups. GAL can be classed as non-inferior compared to COL and has the potential to be adopted in low resource settings.",2020,The intraoperative vital signs were better in the GAL group [p < 0.05].,['100 patients who met the inclusion criteria'],"['GAL versus COL', 'MAS (Cholecystectomies and appendectomies', 'Gasless Laparoscopy', 'RCT', 'Gasless laparoscopic surgeries [GAL', 'Minimal access surgery [MAS', 'GAL', 'conventional Laparoscopic surgeries [COL']","['postoperative pain score', 'mean operating time', 'intraoperative vital signs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",100.0,0.035368,The intraoperative vital signs were better in the GAL group [p < 0.05].,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi. Electronic address: anurag.alok@gmail.com.'}, {'ForeName': 'Lovenish', 'Initials': 'L', 'LastName': 'Bains', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}, {'ForeName': 'Gnanaraj', 'Initials': 'G', 'LastName': 'Jesudin', 'Affiliation': 'Project GILLS Association of Rural Surgeons of India.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Aruparayil', 'Affiliation': ""Leeds Institute of Medical Research at St. James's, University of Leeds, UK.""}, {'ForeName': 'Rajdeep', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shashi', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.07.783']
1966,32827709,Acute effect of inspiratory resistive loading on sprint interval exercise performance in team-sport athletes.,"This study examined acute effects of inspiratory resistive loading (IRL) during rest intervals on sprint interval exercise (SIE) performance. In a randomized crossover design, nine collegiate basketball players performed IRL (15 cmH 2 O) or passive recovery (CON) at 5-min rest intervals during and immediately after 6 sets of a 30-s SIE test. Performance, muscular oxygenation of vastus lateralis, blood lactate and pH were measured at each condition. Blood lactate at 5-min (-20.5 %) and 20-min (-21.3 %) after SIE were significantly lower in IRL than in CON. The pH at 5-min after SIE was significantly higher in IRL than in CON (+0.8 %, p <  0.05). However, the total work in IRL was significantly lower than in CON (-2.7 %, p <  0.05). Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5 %, p <  0.05). The IRL could attenuate exercise-induced metabolic acidosis; however, the decreased blood flow at rest intervals might increase the physical challenge in SIE.",2020,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).",['team-sport athletes'],"['inspiratory resistive loading (IRL', 'CON', 'inspiratory resistive loading', 'IRL (15\u2009cmH 2 O) or passive recovery (CON']","['sprint interval exercise performance', 'Blood lactate', 'IRL', 'sprint interval exercise (SIE) performance', 'total hemoglobin at rest intervals in IRL', 'blood flow', 'Performance, muscular oxygenation of vastus lateralis, blood lactate and pH', 'total work in IRL']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",,0.0174742,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).","[{'ForeName': 'Ching-Feng', 'Initials': 'CF', 'LastName': 'Cheng', 'Affiliation': 'Department of Athletic Performance, National Taiwan Normal University, Taipei, Taiwan; Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan. Electronic address: andescheng@ntnu.edu.tw.'}, {'ForeName': 'Wei-Chieh', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Graduate Institute of Sports Training, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Wei', 'Initials': 'TW', 'LastName': 'Chen', 'Affiliation': 'Physical Education Office, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103531']
1967,32827752,"Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: A randomized, open-label study.","AIMS


Sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase (DPP)-4 inhibitors added to insulin regimens in patients with type 2 diabetes mellitus (T2DM) can improve glycaemic control. This study compared the efficacy and safety of empagliflozin and linagliptin added to premixed insulin therapy in patients with poorly controlled T2DM.
METHODS


In this 24-week, open-label, parallel-design randomized controlled trial, patients with poorly controlled T2DM despite a premixed insulin regimen were randomized to receive 5mg of linagliptin (n=53) or 25mg of empagliflozin (n=53) for 24 weeks.
RESULTS


At week 24, changes in glycated haemoglobin (HbA1c) from baseline were -0.06±0.17% and -1.01±0.16% in the linagliptin and empagliflozin groups, respectively, and the mean treatment HbA1c difference was -0.88% (95% CI: -1.33, -0.43). At week 24, the empagliflozin group showed significant reductions, compared with the linagliptin group, in fasting plasma glucose (P<0.001), body weight (P<0.001), systolic blood pressure (P=0.003) and total daily insulin dose (P=0.042). Hypoglycaemia was reported to be slightly, and not significantly, higher in the empagliflozin group vs linagliptin group (30.2% vs 22.6%, respectively; P=0.51). Similar percentages of patients (1.9%) had urinary tract infections in the two groups.
CONCLUSION


In Asian patients with inadequately controlled T2DM while taking premixed insulin, the addition of empagliflozin for 24 weeks provided better glycaemic control and greater reductions in body weight and systolic blood pressure than the addition of linagliptin. Clinical Trial Registration #: NCT03458715.",2020,"At week 24, the empagliflozin group showed significant reductions, compared with the linagliptin group, in fasting plasma glucose (P<0.001), body weight (P<0.001), systolic blood pressure (P=0.003) and total daily insulin dose (P=0.042).","['patients with poorly controlled T2DM', 'patients with uncontrolled type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'Asian patients with inadequately controlled T2DM while taking', 'patients with poorly controlled T2DM despite a premixed insulin regimen']","['DPP)-4 inhibitors added to insulin regimens', 'empagliflozin and linagliptin', 'empagliflozin', 'premixed insulin therapy', 'empagliflozin vs linagliptin', 'premixed insulin', 'Sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase ', 'linagliptin']","['urinary tract infections', 'total daily insulin dose', 'glycated haemoglobin (HbA1c', 'body weight', 'efficacy and safety', 'body weight and systolic blood pressure', 'systolic blood pressure', 'fasting plasma glucose', 'Hypoglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.108803,"At week 24, the empagliflozin group showed significant reductions, compared with the linagliptin group, in fasting plasma glucose (P<0.001), body weight (P<0.001), systolic blood pressure (P=0.003) and total daily insulin dose (P=0.042).","[{'ForeName': 'S-C', 'Initials': 'SC', 'LastName': 'Liu', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, New Taipei City, Taiwan.'}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, New Taipei City, Taiwan.'}, {'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Chuang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'F-J', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Biomedical Informatics, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Zeng', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, New Taipei City, Taiwan; Institute of Public Health, National Yang Ming University, Taipei, Taiwan. Electronic address: starrydouchain@gmail.com.'}]",Diabetes & metabolism,['10.1016/j.diabet.2020.08.001']
1968,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
1969,32802823,Effect of hypertonic saline on mucociliary clearance and clinical outcomes in chronic bronchitis.,"Background


Mucus dehydration and impaired mucus clearance are common features of cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD). In CF, inhaled hypertonic saline (HS) improves lung function and produces sustained increases in mucociliary clearance (MCC). We hypothesised that administration of HS (7% NaCl) twice daily for 2 weeks would improve clinical outcomes and produce sustained increases in MCC in COPD subjects with a chronic bronchitis (CB) phenotype.
Methods


Twenty-two CB subjects completed a double-blinded, crossover study comparing inhaled HS to a hypotonic control solution (0.12% saline) administered  via  nebuliser twice daily for 2 weeks. Treatment order was randomised. During each treatment period, symptoms and spirometry were measured. MCC was measured at baseline, shortly after initial study agent administration, and approximately 12 h after the final dose.
Results


HS was safe and well tolerated but overall produced no significant improvements in spirometry or patient-reported outcomes. CB subjects had slower baseline MCC than healthy subjects. The MCC rates over 60 min (Ave60Clr) in CB subjects following 2 weeks of HS were not different from 0.12% saline but were slower than baseline (Ave60Clr was 9.1±6.3% at baseline  versus  5.3±6.9% after HS; p<0.05). Subgroup analyses determined that subjects with residual baseline central lung clearance (14 subjects) had improved spirometry and symptoms following treatment with HS, but not 0.12% saline, treatment.
Conclusions


Inhaled HS appeared to be safe in a general CB population. A specific phenotypic subgroup may benefit from HS but requires additional study.",2020,The MCC rates over 60 min (Ave60Clr) in CB subjects following 2 weeks of HS were not different from 0.12% saline but were slower than baseline (Ave60Clr was 9.1±6.3% at baseline  versus  5.3±6.9% after HS; p<0.05).,"['chronic bronchitis', 'COPD subjects with a chronic bronchitis (CB) phenotype', 'cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD', 'Methods\n\n\nTwenty-two CB subjects']","['HS', 'hypotonic control solution', 'hypertonic saline (HS', 'inhaled HS', 'hypertonic saline']","['mucociliary clearance and clinical outcomes', 'MCC rates', 'clinical outcomes', 'spirometry and symptoms', 'mucociliary clearance (MCC', 'lung function', 'residual baseline central lung clearance', 'MCC', 'safe and well tolerated']","[{'cui': 'C0008677', 'cui_str': 'Chronic bronchitis'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",22.0,0.419048,The MCC rates over 60 min (Ave60Clr) in CB subjects following 2 weeks of HS were not different from 0.12% saline but were slower than baseline (Ave60Clr was 9.1±6.3% at baseline  versus  5.3±6.9% after HS; p<0.05).,"[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Bennett', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Ashley G', 'Initials': 'AG', 'LastName': 'Henderson', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Ceppe', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kirby L', 'Initials': 'KL', 'LastName': 'Zeman', 'Affiliation': 'Center for Environmental Medicine, Asthma and Lung Biology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Center for Environmental Medicine, Asthma and Lung Biology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gladman', 'Affiliation': 'Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Fuller', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gazda', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Button', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Boucher', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Donaldson', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",ERJ open research,['10.1183/23120541.00269-2020']
1970,32805434,Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.,"INTRODUCTION


Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
OBJECTIVE


To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs.
METHODS AND ANALYSIS


The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.",2020,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","['152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose', ""cardiorespiratory failure survivors' psychological distress (LIFT2""]","['self-directed mobile mindfulness intervention', 'LIFT intervention', 'telephone-based mindfulness program or education control']","['change in depression symptoms 1\u202fmonth from randomization measured by the PHQ-9 instrument', 'LIFT reduced distress symptoms', 'anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1444565', 'cui_str': 'Cardiorespiratory failure'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",152.0,0.143957,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics, Duke University and the Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Center for Global Health, Duke University, Durham, NC, United States of America. Electronic address: john.gallis@duke.edu.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: laura.porter@duke.edu.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Greeson', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: greeson@rowan.edu.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Gremore', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: tina.gremore@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ungar', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: amu@uw.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'McKeehan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: jeffrey.mckeehan@cuanschutz.edu.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'McDowell', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: brittany.mcdowell@duke.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McDaniel', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: hannah.mcdaniel@cuanschutz.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: marc.moss@cuanschutz.edu.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: houghc@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106119']
1971,32805520,Blunted salivary cortisol response to psychosocial stress in women with posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD) is characterized by alterations in the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system (SNS). There is evidence for a blunted HPA axis reactivity to psychosocial stress. Less is known about how the SNS reacts to psychosocial stress. Here, we compared the HPA axis and SNS responses to psychosocial stress and a non-stressful condition in patients with PTSD and in healthy individuals. Twenty-one women with PTSD and 32 healthy women participated in the Trier social stress test (TSST) and placebo TSST (P-TSST). We measured salivary cortisol, alpha amylase activity and blood pressure before and after the tests. Subjective perceived stress response was also assessed. We found a blunted cortisol response to the TSST in patients with PTSD compared with healthy participants 10 min (t (51) = -2.58, p = .01) and 25 min (t (51) = -2.16, p = .04) after TSST. We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05). Patients with PTSD, but not healthy participants, reported more dissociative symptoms (t (20) = -2.31, p = .03) and being more tired (t (20) = 2.90, p = .01) directly after TSST compared with the placebo condition. Our results suggest a blunted HPA stress reactivity and an increased subjective perceived stress response in female patients with PTSD. Longitudinal studies could test if these altered stress responses constitute a predisposition to or a cause of PTSD. Future studies should investigate whether these results are transferable to men.",2020,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"['Posttraumatic stress disorder (PTSD', 'patients with PTSD and in healthy individuals', 'women with posttraumatic stress disorder', 'patients with PTSD compared with healthy participants 10\xa0min (t (51)\xa0', 'female patients with PTSD', 'Twenty-one women with PTSD and 32 healthy women participated in the']","['TSST', 'Trier social stress test (TSST) and placebo TSST (P-TSST']","['blunted cortisol response', 'blunted HPA stress reactivity', 'Subjective perceived stress response', 'SNS reactivity', 'dissociative symptoms', 'salivary cortisol, alpha amylase activity and blood pressure', 'Blunted salivary cortisol response']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",21.0,0.0110716,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: sophie.metz@charite.de.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.014']
1972,32807241,"Multi-centre, three arm, randomized controlled trial on the use of methylprednisolone and unfractionated heparin in critically ill ventilated patients with pneumonia from SARS-CoV-2 infection: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


To assess the hypothesis that an adjunctive therapy with methylprednisolone and unfractionated heparin (UFH) or with methylprednisolone and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill ventilated patients with pneumonia from SARS-CoV-2 infection compared to LMWH alone.
TRIAL DESIGN


The study is designed as a multi-centre, interventional, parallel group, superiority, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned to one of the three treatment groups in a ratio 1:1:1.
PARTICIPANTS


Inpatients will be recruited from 8 Italian Academic and non-Academic Intensive Care Units INCLUSION CRITERIA (ALL REQUIRED): 1. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) 2. Positive pressure ventilation (either non-invasive or invasive) from > 24 hours 3. Invasive mechanical ventilation from < 96 hours 4. PaO 2 /FiO 2  ratio lower than 150 mmHg 5. D-dimer level > 6 times the upper limit of normal reference range 6. C-reactive Protein > 6-fold upper the limit of normal reference range EXCLUSION CRITERIA: 1. Age < 18 years 2. On-going treatment with anticoagulant drugs 3. Platelet count < 100.000/mm 3  4. History of heparin-induced thrombocytopenia 5. Allergy to sodium enoxaparin or other LMWH, UFH or methylprednisolone 6. Active bleeding or on-going clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment 7. Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery 8. Chronic assumption or oral corticosteroids 9. Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available 10. Clinical decision to withhold life-sustaining treatment or ""too sick to benefit"" 11. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition) 12. Lack or withdrawal of informed consent INTERVENTION AND COMPARATOR: • LMWH group: patients in this group will be administered enoxaparin at standard prophylactic dosage. • LMWH + steroid group: patients in this group will receive enoxaparin at standard prophylactic dosage and methylprednisolone. • UFH + steroid group: patients in this group will receive UFH at therapeutic dosages and methylprednisolone. UFH will be administered intravenously in UFH + steroid group at therapeutic doses. The infusion will be started at an infusion rate of 18 UI/kg/hour and then modified to obtain aPTT Ratio in between the range of 1.5-2.0. aPTT will be periodically checked at intervals no longer than 12 hours. The treatment with UFH will be administered up to ICU discharge. After ICU discharge anticoagulant therapy may be interrupted or switched to prophylaxis with LMWH in the destination ward up to clinical judgement of the attending physician. Enoxaparin will be administered in both LMWH group and LMWH + steroid group at standard prophylactic dose (i.e., 4000 UI once day, increased to 6000 UI once day for patients weighting more than 90 kg). The treatment will be administered subcutaneously once a day up to ICU discharge. After ICU discharge it may be continued or interrupted in the destination ward up to clinical judgement of the attending physician. Methylprednisolone will be administered in both LMWH + steroid group and UHF + steroid group intravenously with an initial bolus of 0,5 mg/kg followed by administration of 0,5 mg/kg 4 times daily for 7 days, 0,5 mg/kg 3 times daily from day 8 to day 10, 0,5 mg/kg 2 times daily at days 11 and 12 and 0,5 mg/kg once daily at days 13 and 14.
MAIN OUTCOMES


Primary Efficacy Endpoint: All-cause mortality at day 28 Secondary Efficacy Endpoints: - Ventilation free days (VFDs) at day 28, defined as the total number of days that patient is alive and free of ventilation (either invasive or non-invasive) between randomization and day 28 (censored at hospital discharge). - Need of rescue administration of high-dose steroids or immune-modulatory drugs; - Occurrence of switch from non-invasive to invasive mechanical ventilation during ICU stay; - Delay from start of non-invasive ventilation to switch to invasive ventilation; - All-cause mortality at ICU discharge and hospital discharge; - ICU free days (IFDs) at day 28, defined as the total number of days between ICU discharge and day 28. - Occurrence of new infections from randomization to day 28; including infections by Candida, Aspergillus, Adenovirus, Herpes Virus e Cytomegalovirus - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay. - Objectively confirmed venous thromboembolism, stroke or myocardial infarction; Safety endpoints: - Occurrence of major bleeding, defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death); - Occurrence of clinically relevant non-major bleeding, defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm 2 , intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.
RANDOMIZATION


A block randomisation will be used with variable block sizes (block size 4-6-8), stratified by 3 factors: Centre, BMI (<30/≥30) and Age (<75/≥75). Central randomisation will be performed using a secure, web-based, randomisation system with an allocation ratio of 1:1:1. The allocation sequence will be generated by the study statistician using computer generated random numbers.
BLINDING (MASKING)


Participants to the study will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The target sample size is based on the hypothesis that the combined use of UHF and steroid versus the LMWH group will significantly reduce the risk of death at day 28. The overall sample size in this study is expected to be 210 with a randomization 1:1:1 and seventy patients in each group. Assuming an alpha of 2.5% (two tailed) and mortality rate in LMWH group of 50%, as indicated from initial studies of ICU patients, the study will have an 80% power to detect at least a 25 % absolute reduction in the risk of death between: a) LMHW + steroid group and LMWH group or b) UHF + steroid group and LMWH group. The study has not been sized to assess the difference between LMHW + steroid group and UHF + steroid group, therefore the results obtained from this comparison will need to be interpreted with caution and will need further adequately sized studies confirm the effect. On the basis of a conservative estimation, that 8 participating sites admit an average of 3 eligible patients per month per centre (24 patients/month). Assuming that 80 % of eligible patients are enrolled, recruitment of 210 participants will be completed in approximately 10 months.
TRIAL STATUS


Protocol version 1.1 of April 26 th , 2020. Recruitment start (expected): September 1 st , 2020 Recruitment finish (expected): June 30 th , 2021 TRIAL REGISTRATION: EudraCT number 2020-001921-30 , registered on April 15 th , 2020 AIFA approval on May 4 th , 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Central randomisation will be performed using a secure, web-based, randomisation system with an allocation ratio of 1:1:1.","['Patients, who satisfy all inclusion criteria and no exclusion criteria', 'critically ill ventilated patients with pneumonia from SARS-CoV-2 infection', 'Inpatients will be recruited from 8 Italian Academic and non-Academic Intensive Care Units INCLUSION CRITERIA (ALL REQUIRED): 1', 'Protocol version 1.1 of April 26 th , 2020', 'Age', '0,5', 'group', '2020-001921-30 , registered on April 15 th , 2020 AIFA approval on May 4 th ', 'critically-ill ventilated patients with pneumonia from SARS-CoV-2 infection compared to LMWH alone']","['Invasive mechanical ventilation', 'LMWH, UFH or methylprednisolone 6', 'LMWH', 'Positive pressure ventilation (either non-invasive or invasive', 'methylprednisolone and low molecular weight heparin (LMWH', 'UFH + steroid', 'LMWH + steroid group and UHF + steroid', 'LMWH + steroid', 'UFH', 'Enoxaparin', 'sodium enoxaparin', 'methylprednisolone', 'Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material', 'methylprednisolone and unfractionated heparin (UFH', 'enoxaparin', 'Methylprednisolone', 'methylprednisolone and unfractionated heparin']","['risk of death', 'Active bleeding', 'Platelet count', 'cause mortality at day 28 Secondary Efficacy Endpoints: - Ventilation free days (VFDs) at day 28, defined as the total number of days', 'infections by Candida, Aspergillus, Adenovirus, Herpes Virus e Cytomegalovirus - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay', 'venous thromboembolism, stroke or myocardial infarction; Safety endpoints: - Occurrence of major bleeding, defined as transfusion of 2 or more units of packed red blood cells', 'mortality rate', 'Pregnancy or breastfeeding or positive pregnancy test', 'life expectancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0004034', 'cui_str': 'Aspergillus'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",210.0,0.145771,"Central randomisation will be performed using a secure, web-based, randomisation system with an allocation ratio of 1:1:1.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Busani', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Terapia Intensiva Polivalente, Policlinico di Modena, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Via del Pozzo, 71, 41124, Modena, Italy. stefano.busani@unimore.it.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Tosi', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Terapia Intensiva Polivalente, Policlinico di Modena, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Via del Pozzo, 71, 41124, Modena, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Mighali', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vandelli', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': ""Cattedra di Statistica Medica, Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto, Università di Modena e Reggio Emilia, Modena, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marietta', 'Affiliation': 'Haematology Unit, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Forfori', 'Affiliation': 'Dipartimento di Anestesia e Terapia Intensiva, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Abele', 'Initials': 'A', 'LastName': 'Donati', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, Torrette di Ancona, Italy.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Cinnella', 'Affiliation': 'Department of Anesthesia and Intensive Care, O.O. Riuniti Hospital, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Amato', 'Initials': 'A', 'LastName': 'De Monte', 'Affiliation': 'Anesthesiology and Intensive Care 1, Department of Anesthesia and Intensive Care, Azienda Sanitaria Universitaria Integrata-Udine, Udine, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pasero', 'Affiliation': 'Department of Medical, Surgical and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Bellani', 'Affiliation': 'Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tascini', 'Affiliation': 'Clinica di Malattie Infettive, Azienda Sanitaria Universitaria Friuli centrale, Udine, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Foti', 'Affiliation': 'Department of Emergency Medicine, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ranieri', 'Affiliation': ""Anesthesia and Intensive Care Medicine, University Hospital of Bologna Sant'Orsola, Alma Mater Studiorum, University of Bologna, Bologna, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Girardis', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Terapia Intensiva Polivalente, Policlinico di Modena, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Via del Pozzo, 71, 41124, Modena, Italy.'}]",Trials,['10.1186/s13063-020-04645-z']
1973,32809002,"Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial.","Importance


Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.
Objective


To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression.
Design, Setting, and Participants


Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018.
Interventions


Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months.
Main Outcomes and Measures


The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol.
Results


Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0).
Conclusions and Relevance


Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings.
Trial Registration


ClinicalTrials.gov Identifier: NCT02022111.",2020,"A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]).","['adults with diabetes and depression', 'Patients With Depression and Diabetes in India', 'people with diabetes', 'patients with diabetes and depression in India', '404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial', '4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range,\u20090-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018']","['intervention group (n\u2009=\u2009196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention', 'usual care over 24 months', 'collaborative care vs usual care', 'Collaborative Care Model']","['severe hypoglycemia', 'Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol', 'cardiovascular events or hospitalizations', 'Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol', 'SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm', 'death', 'stroke', 'cardiometabolic indices', 'depressive symptoms and cardiometabolic indices', 'SBP <130 mm Hg, LDL cholesterol', 'SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol', 'Symptom Checklist Depression Scale (SCL-20) scores', 'Serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",404.0,0.155763,"A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]).","[{'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Chwastiak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Subramani', 'Initials': 'S', 'LastName': 'Poongothai', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Karl M F', 'Initials': 'KMF', 'LastName': 'Emmert-Fees', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Shivani A', 'Initials': 'SA', 'LastName': 'Patel', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Ranjit Mohan', 'Initials': 'RM', 'LastName': 'Anjana', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sagar', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Shankar', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Gumpeny R', 'Initials': 'GR', 'LastName': 'Sridhar', 'Affiliation': 'Endocrine and Diabetes Centre, Visakhapatnam, India.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Kosuri', 'Affiliation': 'Department of Psychology, Andhra University, Visakhapatnam, India.'}, {'ForeName': 'Aravind R', 'Initials': 'AR', 'LastName': 'Sosale', 'Affiliation': 'Diacon Hospital, Diabetes Care and Research Center, Bangalore, India.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Sosale', 'Affiliation': 'Diacon Hospital, Diabetes Care and Research Center, Bangalore, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Endocrinology & Metabolism, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.11747']
1974,32809003,"Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial.","Importance


The combination of ascorbic acid, corticosteroids, and thiamine has been identified as a potential therapy for septic shock.
Objective


To determine whether the combination of ascorbic acid, corticosteroids, and thiamine attenuates organ injury in patients with septic shock.
Design, Setting, and Participants


Randomized, blinded, multicenter clinical trial of ascorbic acid, corticosteroids, and thiamine vs placebo for adult patients with septic shock. Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States. Follow-up continued until November 26, 2019.
Interventions


Patients were randomly assigned to receive parenteral ascorbic acid (1500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days (n = 103) or placebo in matching volumes at the same time points (n = 102).
Main Outcomes and Measures


The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score (range, 0-24; 0 = best) between enrollment and 72 hours. Key secondary outcomes included kidney failure and 30-day mortality. Patients who received at least 1 dose of study drug were included in analyses.
Results


Among 205 randomized patients (mean age, 68 [SD, 15] years; 90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group). Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1 [-4.1] points with placebo; adjusted mean difference, -0.8; 95% CI, -1.7 to 0.2; P = .12 for interaction). There was no statistically significant difference in the incidence of kidney failure (31.7% with intervention vs 27.3% with placebo; adjusted risk difference, 0.03; 95% CI, -0.1 to 0.2; P = .58) or in 30-day mortality (34.7% vs 29.3%, respectively; hazard ratio, 1.3; 95% CI, 0.8-2.2; P = .26). The most common serious adverse events were hyperglycemia (12 patients with intervention and 7 patients with placebo), hypernatremia (11 and 7 patients, respectively), and new hospital-acquired infection (13 and 12 patients, respectively).
Conclusions and Relevance


In patients with septic shock, the combination of ascorbic acid, corticosteroids, and thiamine, compared with placebo, did not result in a statistically significant reduction in SOFA score during the first 72 hours after enrollment. These data do not support routine use of this combination therapy for patients with septic shock.
Trial Registration


ClinicalTrials.gov Identifier: NCT03389555.",2020,"Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1","['Patients who received at least 1 dose of study drug were included in analyses', 'patients with septic shock', '205 randomized patients (mean age, 68 [SD, 15] years', 'adult patients with septic shock', 'Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States', 'Septic Shock', '90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group']","['ascorbic acid, corticosteroids, and thiamine', 'Ascorbic Acid, Corticosteroids, and Thiamine', 'hydrocortisone (50 mg), and thiamine', 'parenteral ascorbic acid', 'ascorbic acid, corticosteroids, and thiamine vs placebo', 'placebo']","['Sequential Organ Failure Assessment (SOFA) score', 'new hospital-acquired infection', 'kidney failure and 30-day mortality', '30-day mortality', 'incidence of kidney failure', 'SOFA score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205721', 'cui_str': 'Nosocomial infection'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",205.0,0.79798,"Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1","[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hou', 'Affiliation': ""Division of Emergency Critical Care Medicine, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Emergency Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Pratik B', 'Initials': 'PB', 'LastName': 'Doshi', 'Affiliation': 'Department of Emergency Medicine, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Sherwin', 'Affiliation': 'Sinai Grace Hospital, Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Berg', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Cocchi', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'McCannon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mount Auburn Hospital, Cambridge, Massachusetts.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hershey', 'Affiliation': 'Division of Critical Care Medicine, South Shore Hospital, Weymouth, Massachusetts.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Hilewitz', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Maksim', 'Initials': 'M', 'LastName': 'Korotun', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Lance B', 'Initials': 'LB', 'LastName': 'Becker', 'Affiliation': 'Department of Emergency Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Ronny M', 'Initials': 'RM', 'LastName': 'Otero', 'Affiliation': 'Beaumont Hospital, Department of Emergency Medicine, Oakland University William Beaumont School of Medicine, Beaumont, Michigan.'}, {'ForeName': 'Junior', 'Initials': 'J', 'LastName': 'Uduman', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Ayan', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Critical Care Medicine, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.11946']
1975,32809014,Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial.,"Importance


Cryptogenic sensory polyneuropathy (CSPN) is a common generalized slowly progressive neuropathy, second in prevalence only to diabetic neuropathy. Most patients with CSPN have significant pain. Many medications have been tried for pain reduction in CSPN, including antiepileptics, antidepressants, and sodium channel blockers. There are no comparative studies that identify the most effective medication for pain reduction in CSPN.
Objective


To determine which medication (pregabalin, duloxetine, nortriptyline, or mexiletine) is most effective for reducing neuropathic pain and best tolerated in patients with CSPN.
Design, Setting, and Participants


From December 1, 2014, through October 20, 2017, a bayesian adaptive, open-label randomized clinical comparative effectiveness study of pain in 402 participants with CSPN was conducted at 40 neurology care clinics. The trial included response adaptive randomization. Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain). Participant allocation to 1 of 4 drug groups used the utility function and treatment's sample size for response adaptation randomization. At each interim analysis, a decision was made to continue enrolling (up to 400 participants) or stop the whole trial for success (80% power). Patient engagement was maintained throughout the trial, which helped guide the study and identify ways to communicate and disseminate information. Analysis was performed from December 11, 2015, to January 19, 2018.
Interventions


Participants were randomized to receive nortriptyline (n = 134), duloxetine (n = 126), pregabalin (n = 73), or mexiletine (n = 69).
Main Outcomes and Measures


The primary outcome was a utility function that was a composite of the efficacy (participant reported pain reduction of ≥50% from baseline to week 12) and quit (participants who discontinued medication) rates.
Results


Among the 402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3%]), the utility function of nortriptyline was 0.81 (95% bayesian credible interval [CrI], 0.69-0.93; 34 of 134 [25.4%] efficacious; and 51 of 134 [38.1%] quit), of duloxetine was 0.80 (95% CrI, 0.68-0.92; 29 of 126 [23.0%] efficacious; and 47 of 126 [37.3%] quit), pregabalin was 0.69 (95% CrI, 0.55-0.84; 11 of 73 [15.1%] efficacious; and 31 of 73 [42.5%] quit), and mexiletine was 0.58 (95% CrI, 0.42-0.75; 14 of 69 [20.3%] efficacious; and 40 of 69 [58.0%] quit). The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
Conclusions and Relevance


This study found that, although there was no clearly superior medication, nortriptyline and duloxetine outperformed pregabalin and mexiletine when pain reduction and undesirable adverse effects are combined to a single end point.
Trial Registration


ClinicalTrials.gov Identifier: NCT02260388.",2020,"The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
","['Real Life Situations (PAIN-CONTRoLS', '402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3', 'patients with CSPN', '402 participants with CSPN was conducted at 40 neurology care clinics', 'Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain']","['mexiletine', 'nortriptyline', 'duloxetine', 'pregabalin', 'medication (pregabalin, duloxetine, nortriptyline, or mexiletine']","['neuropathic pain and best tolerated', 'utility function that was a composite of the efficacy (participant reported pain reduction', 'pain reduction and undesirable adverse effects', 'pain']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0271681', 'cui_str': 'Sensory polyneuropathy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0025887', 'cui_str': 'Mexiletine'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",402.0,0.150063,"The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Herbelin', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Kim S', 'Initials': 'KS', 'LastName': 'Kimminau', 'Affiliation': 'Department of Family Medicine, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Dinesh Pal', 'Initials': 'DP', 'LastName': 'Mudaranthakam', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Jawdat', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Iyadurai', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'Amro', 'Initials': 'A', 'LastName': 'Stino', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kissel', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pascuzzi', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wicklund', 'Affiliation': 'Pennsylvania State University, Centre County.'}, {'ForeName': 'Aiesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Pennsylvania State University, Centre County.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walk', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Quan', 'Affiliation': 'University of Colorado-Denver, Denver.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': 'Texas Neurology, Dallas.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Tobon', 'Affiliation': 'UT Health Science-San Antonio, San Antonio, Texas.'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'Barrow Neurology, Phoenix, Arizona.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida Jacksonville, Jacksonville.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Hayat', 'Affiliation': 'Saint Louis University, St Louis, Missouri.'}, {'ForeName': 'Yuebing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Pariwat', 'Initials': 'P', 'LastName': 'Thaisetthawatkul', 'Affiliation': 'University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Suur', 'Initials': 'S', 'LastName': 'Biliciler', 'Affiliation': 'University of Texas Health Science Center at Houston.'}, {'ForeName': 'Khema', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Salajegheh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Trivedi', 'Affiliation': 'UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Mallonee', 'Affiliation': 'Hutchinson Clinic, Hutchinson, Kansas.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Burns', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jacoby', 'Affiliation': 'Mercy Medical Center, Des Moines, Iowa.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida-Tampa, Tampa.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Ramchandren', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bazant', 'Affiliation': 'Norton Neurology Services, Louisville, Kentucky.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Austin', 'Affiliation': 'Seton Brain and Spine, Austin, Texas.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'Yessar', 'Initials': 'Y', 'LastName': 'Hussain', 'Affiliation': 'Austin Neuromuscular Center, Austin, Texas.'}, {'ForeName': 'Christen', 'Initials': 'C', 'LastName': 'Kutz', 'Affiliation': 'Colorado Springs Neurological Associates, Colorado Springs.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Twydell', 'Affiliation': 'Spectrum Health, Grand Rapids, Michigan.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scelsa', 'Affiliation': 'Mt Sinai Beth Israel, New York, New York.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Kushlaf', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': 'University of Florida-Gainesville, Gainesville.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hehir', 'Affiliation': 'University of Vermont, Burlington.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kolb', 'Affiliation': 'University of Vermont, Burlington.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Ralph', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Barboi', 'Affiliation': 'NorthShore University Health System, Evanston, Illinois.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Neurological Services of Orlando Research, Orlando, Florida.'}, {'ForeName': 'Moiz', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Grand Medical Clinic, Katy, Texas.'}, {'ForeName': 'Anza', 'Initials': 'A', 'LastName': 'Memon', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saperstein', 'Affiliation': 'Phoenix Neurological, Phoenix, Arizona.'}, {'ForeName': 'Jau-Shin', 'Initials': 'JS', 'LastName': 'Lou', 'Affiliation': 'University of North Dakota, Grand Forks.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City.'}, {'ForeName': 'Tiyonnoh', 'Initials': 'T', 'LastName': 'Cash', 'Affiliation': 'University of California-Irvine, Irvine.'}]",JAMA neurology,['10.1001/jamaneurol.2020.2590']
1976,32811531,Treatment of severe COVID-19 with human umbilical cord mesenchymal stem cells.,"BACKGROUND


COVID-19 is a highly infectious respiratory disease. No therapeutics have yet been proven effective for treating severe COVID-19.
OBJECTIVES


To determine whether human umbilical cord mesenchymal stem cell infusion may be effective and safe for the treatment of severe COVID-19.
METHODS


Patients with severe COVID-19 were randomly divided into 2 groups: the standard treatment group and the standard treatment plus hUC-MSC infusion group. The incidence of progression from severe to critical illness, 28-day mortality, clinical symptom improvement, time to clinical symptom improvement, hematologic indicators including C-reactive protein, lymphocyte number, and interleukin 6, and imaging changes were observed and compared between the two groups.
MEASUREMENTS AND MAIN RESULTS


The incidence of progression from severe to critical illness and the 28-day mortality rate were 0 in the hUC-MSC treatment group, while 4 patients in the control group deteriorated to critical condition and received invasive ventilation; 3 of them died, and the 28-day mortality rate was 10.34%. In the hUC-MSC treatment group, the time to clinical improvement was shorter than that in the control group. Clinical symptoms of weakness and fatigue, shortness of breath, and low oxygen saturation obviously improved beginning on the third day of stem cell infusion and reached a significant difference on day 7. CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.
CONCLUSIONS


Intravenous transplantation of hUC-MSCs is a safe and effective method that can be considered a salvage and priority treatment option for severe COVID-19.
TRIAL REGISTRATION


Chinese Clinical Trial Registration; ChiCTR2000031494; Registered on 2 April 2020; http:// www.medresman.org.",2020,"CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.
","['severe COVID-19 with human umbilical cord mesenchymal stem cells', 'Patients with severe COVID-19']","['hUC-MSC', 'human umbilical cord mesenchymal stem cell infusion', 'standard treatment group and the standard treatment plus hUC-MSC infusion group']","['time to clinical improvement', 'incidence of progression from severe to critical illness, 28-day mortality, clinical symptom improvement, time to clinical symptom improvement, hematologic indicators including C-reactive protein, lymphocyte number, and interleukin 6, and imaging changes', 'Clinical symptoms of weakness and fatigue, shortness of breath, and low oxygen saturation', 'lung inflammation absorption', '28-day mortality rate', 'CRP and IL-6 levels']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.062267,"CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shu', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Niu', 'Affiliation': 'Department of Critical Care Medicine, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu, China.'}, {'ForeName': 'Ruyou', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, Huangshi Central Hospital, Hangshi, 435000, Hubei, China.'}, {'ForeName': 'Tingrong', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, Huangshi Hospital of Traditional Chinese Medicine, Hangshi, 435000, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Cell Tech Medical Research Institute, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Ningfei', 'Initials': 'N', 'LastName': 'Ji', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Nephrology, Huangshi Hospital of Traditional Chinese Medicine, Hangshi, 435000, Hubei, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Mingjing', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Kaili', 'Initials': 'K', 'LastName': 'Deng', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Ganzhu', 'Initials': 'G', 'LastName': 'Feng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the Second Affiliated Hospital of Nanjing Medical University, Address: No. 121 Jiangjiayuan Rd, Gulou District, Nanjing, 210011, Jiangsu, China. fenggz163@163.com.'}]",Stem cell research & therapy,['10.1186/s13287-020-01875-5']
1977,32812363,Transcutaneous spinal direct current stimulation increases corticospinal transmission and enhances voluntary motor output in humans.,"Optimization of motor performance is of importance in daily life, in relation to recovery following injury as well as for elite sports performance. The present study investigated whether transcutaneous spinal direct current stimulation (tsDCS) may enhance voluntary ballistic activation of ankle muscles and descending activation of spinal motor neurons in able-bodied adults. Forty-one adults (21 men; 24.0 ± 3.2 years) participated in the study. The effect of tsDCS on ballistic motor performance and plantar flexor muscle activation was assessed in a double-blinded sham-controlled cross-over experiment. In separate experiments, the underlying changes in excitability of corticospinal and spinal pathways were probed by evaluating soleus (SOL) motor evoked potentials (MEPs) following single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex, SOL H-reflexes elicited by tibial nerve stimulation and TMS-conditioning of SOL H-reflexes. Measures were obtained before and after cathodal tsDCS over the thoracic spine (T11-T12) for 10 min at 2.5 mA. We found that cathodal tsDCS transiently facilitated peak acceleration in the ballistic motor task compared to sham tsDCS. Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes. The short-latency facilitation of the H-reflex by subthreshold TMS, which is assumed to be mediated by the fast conducting monosynaptic corticomotoneuronal pathway, was also enhanced by tsDCS. We argue that tsDCS briefly facilitates voluntary motor output by increasing descending drive from corticospinal neurones to spinal plantar flexor motor neurons. tsDCS can thus transiently promote within-session CNS function and voluntary motor output and holds potential as a technique in the rehabilitation of motor function following central nervous lesions.",2020,"Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes.","['Forty-one adults (21 men; 24.0\xa0±\xa03.2\xa0years) participated in the study', 'able-bodied adults', 'humans']","['transcutaneous spinal direct current stimulation (tsDCS', 'tsDCS', 'single-pulse transcranial magnetic stimulation (TMS', 'Transcutaneous spinal direct current stimulation']","['H-reflex amplitudes', 'ballistic motor performance and plantar flexor muscle activation', 'soleus (SOL) motor evoked potentials (MEPs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}]",41.0,0.088158,"Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes.","[{'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Mikkel M', 'Initials': 'MM', 'LastName': 'Beck', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Therkildsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Svane', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Forman', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Lorentzen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Bernard A', 'Initials': 'BA', 'LastName': 'Conway', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Lundbye-Jensen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Svend S', 'Initials': 'SS', 'LastName': 'Geertsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Jens B', 'Initials': 'JB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}]",Physiological reports,['10.14814/phy2.14531']
1978,32812384,Muscular endurance and muscle metabolic responses to 8 weeks of omega-3 polyunsaturated fatty acids supplementation.,"BACKGROUND


It has been well known that exercise training improves muscular endurance; however, whether nutritional strategies can be used to enhance muscular endurance remains unclear. Herein, we tested the hypothesis that 8 weeks of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation, known to promote oxygen availability and lipid metabolism, would attenuate muscular fatigue caused by numerous muscle contractions.
METHODS


Nineteen healthy men were randomly assigned to a placebo group (n = 9) and fish oil group (n = 10) in a double-blind fashion. The fish oil group consumed EPA-rich fish oil that contains 600-mg EPA and 260-mg DHA per day for 8 weeks. The placebo group received matching capsules for the same duration of time. After the 8-week intervention, subjects performed muscular endurance test that was repeated knee extensions with weights equal to 40% of the subject's body weight.
RESULTS


Maximal repetitions to exhaustion were recorded. In addition, maximum isometric voluntary muscle contraction (MVC), muscle metabolism using near-infrared spectroscopy, and blood lactate were measured during the test. Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups. Similarly, there is no significant difference in oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability, between the groups. Also, MVC and blood lactate did not change between groups.
CONCLUSION


In conclusion, the present study provided evidence that muscle fatigue caused by knee extensions cannot be attenuated by EPA and DHA supplementation in healthy subjects.",2020,"Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups.","['Nineteen healthy men', 'healthy subjects']","['exercise training', 'omega-3 polyunsaturated fatty acids supplementation', 'placebo group (n\xa0=\xa09) and fish oil group', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation', 'placebo']","['maximum isometric voluntary muscle contraction (MVC), muscle metabolism using near-infrared spectroscopy, and blood lactate', 'MVC and blood lactate', 'muscular endurance', 'Muscular endurance and muscle metabolic responses', 'oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",19.0,0.209075,"Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups.","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Morishima', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Laboratory of Health and Sports Sciences, Meiji Gakuin University, Kanagawa, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Ueda', 'Affiliation': 'Faculty of Health and Medical Science, Teikyo Heisei University, Chiba, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ochi', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, Japan.'}]",Physiological reports,['10.14814/phy2.14546']
1979,32813610,Children's Oncology Group AALL0434: A Phase III Randomized Clinical Trial Testing Nelarabine in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia.,"PURPOSE


Nelarabine is effective in inducing remission in patients with relapsed and refractory T-cell acute lymphoblastic leukemia (T-ALL) but has not been fully evaluated in those with newly diagnosed disease.
PATIENTS AND METHODS


From 2007 to 2014, Children's Oncology Group trial AALL0434 (ClinicalTrials.gov identifier: NCT00408005) enrolled 1,562 evaluable patients with T-ALL age 1-31 years who received the augmented Berlin-Frankfurt-Muenster (ABFM) regimen with a 2 × 2 pseudo-factorial randomization to receive escalating-dose methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX) or high-dose MTX (HDMTX) with leucovorin rescue. Intermediate- and high-risk patients were also randomly assigned after induction to receive or not receive six 5-day courses of nelarabine that was incorporated into ABFM. Patients who experienced induction failure were nonrandomly assigned to HDMTX plus nelarabine. Patients with overt CNS disease (CNS3; ≥ 5 WBCs/μL with blasts) received HDMTX and were randomly assigned to receive or not receive nelarabine. All patients, except those with low-risk disease, received cranial irradiation.
RESULTS


The 5-year event-free and overall survival rates were 83.7% ± 1.1% and 89.5% ± 0.9%, respectively. The 5-year disease-free survival (DFS) rates for patients with T-ALL randomly assigned to nelarabine (n = 323) and no nelarabine (n = 336) were 88.2% ± 2.4% and 82.1% ± 2.7%, respectively ( P  = .029). Differences between DFS in a four-arm comparison were significant ( P  = .01), with no interactions between the MTX and nelarabine randomizations ( P  = .41). Patients treated with the best-performing arm, C-MTX plus nelarabine, had a 5-year DFS of 91% (n = 147). Patients who received nelarabine had significantly fewer isolated and combined CNS relapses compared with patients who did not receive nelarabine (1.3% ± 0.63%  v  6.9% ± 1.4%, respectively;  P  = .0001). Toxicities, including neurotoxicity, were acceptable and similar between all four arms.
CONCLUSION


The addition of nelarabine to ABFM therapy improved DFS for children and young adults with newly diagnosed T-ALL without increased toxicity.",2020,"Patients who received nelarabine had significantly fewer isolated and combined CNS relapses compared with patients who did not receive nelarabine (1.3% ± 0.63%  v  6.9% ± 1.4%, respectively;  P  = .0001).","['Patients who experienced induction failure', '1,562 evaluable patients with T-ALL age 1-31 years who received the augmented Berlin-Frankfurt-Muenster (ABFM) regimen with a 2 × 2 pseudo-factorial randomization to receive', 'Intermediate- and high-risk patients', 'patients with relapsed and refractory T-cell acute lymphoblastic leukemia (T-ALL', 'Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia', 'Patients with overt CNS disease (CNS3; ≥ 5 WBCs/μL with blasts) received']","['nelarabine to ABFM therapy', 'escalating-dose methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX) or high-dose MTX (HDMTX) with leucovorin rescue', 'Nelarabine', 'nelarabine', 'HDMTX', 'HDMTX plus nelarabine']","['DFS', '5-year event-free and overall survival rates', 'Toxicities, including neurotoxicity', 'toxicity', 'CNS relapses', '5-year disease-free survival (DFS) rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1961099', 'cui_str': 'T-cell acute lymphoblastic leukemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0337026', 'cui_str': 'Blast'}]","[{'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",336.0,0.122522,"Patients who received nelarabine had significantly fewer isolated and combined CNS relapses compared with patients who did not receive nelarabine (1.3% ± 0.63%  v  6.9% ± 1.4%, respectively;  P  = .0001).","[{'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Dunsmore', 'Affiliation': 'Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, VA.'}, {'ForeName': 'Stuart S', 'Initials': 'SS', 'LastName': 'Winter', 'Affiliation': ""Children's Minnesota Cancer and Blood Disorders Program, Minneapolis, MN.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': ""Laboratory Medicine, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Natia', 'Initials': 'N', 'LastName': 'Esiashvili', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Eisenberg', 'Affiliation': 'Pediatric Hematology/Oncology, University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Briegel', 'Affiliation': ""Pharmacy Department, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hayashi', 'Affiliation': ""Pediatric Hematology/Oncology, Washington School of Medicine, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Gastier-Foster', 'Affiliation': ""Nationwide Children's Hospital, Columbus OH.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Asselin', 'Affiliation': 'Department of Pediatrics, University of Rochester Medical Center and Wilmot Cancer Institute, Rochester, NY.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Pediatric Hematology/Oncology, Baylor College of Medicine/Dan L. Duncan Comprehensive Cancer Center, Houston TX.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Zweidler-Mckay', 'Affiliation': 'ImmunoGen, Waltham, MA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center at New York University Langone Health, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, University of California, San Francisco Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Schultz', 'Affiliation': ""Pediatric Hematology-Oncology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Pediatric Hematology/Oncology, University of Texas Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center at New York University Langone Health, New York, NY.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and The Center for Childhood Cancer Research, The Children's Hospital of Philadelphia and The Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00256']
1980,32831969,Conversational Therapy through Semi-Immersive Virtual Reality Environments for Language Recovery and Psychological Well-Being in Post Stroke Aphasia.,"Aphasia is a highly disabling acquired language disorder generally caused by a left-lateralized brain damage. Even if traditional therapies have been shown to induce an adequate clinical improvement, a large percentage of patients are left with some degree of language impairments. Therefore, new approaches to common speech therapies are urgently needed in order to maximize the recovery from aphasia. The recent application of virtual reality (VR) to aphasia rehabilitation has already evidenced its usefulness in promoting a more pragmatically oriented treatment than conventional therapies (CT). In the present study, thirty-six chronic persons with aphasia (PWA) were randomly assigned to two groups. The VR group underwent conversational therapy during VR everyday life setting observation, while the control group was trained in a conventional setting without VR support. All patients were extensively tested through a neuropsychological battery which included not only measures for language skills and communication efficacy but also self-esteem and quality of life questionnairies. All patients were trained through a conversational approach by a speech therapist twice a week for six months (total 48 sessions). After the treatment, no significant differences among groups were found in the different measures. However, the amount of improvement in the different areas was distributed over far more cognitive and psychological aspects in the VR group than in the control group. Indeed, the within-group comparisons showed a significant enhancement in different language tasks (i.e., oral comprehension, repetition, and written language) only in the VR group. Significant gains, after the treatment, were also found, in the VR group, in different psychological dimensions (i.e., self-esteem and emotional and mood state). Given the importance of these aspects for aphasia recovery, we believe that our results add to previous evidence which points to the ecological validity and feasibility of VR treatment for language recovery and psychosocial well-being.",2020,"However, the amount of improvement in the different areas was distributed over far more cognitive and psychological aspects in the VR group than in the control group.",['thirty-six chronic persons with aphasia (PWA'],"['conversational therapy', 'virtual reality (VR) to aphasia rehabilitation']","['cognitive and psychological aspects', 'language skills and communication efficacy but also self-esteem and quality of life questionnairies', 'language tasks (i.e., oral comprehension, repetition, and written language', 'psychological dimensions (i.e., self-esteem and emotional and mood state']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}]",36.0,0.0168358,"However, the amount of improvement in the different areas was distributed over far more cognitive and psychological aspects in the VR group than in the control group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Giachero', 'Affiliation': 'Aphasia Experimental Laboratory-Fondazione Carlo Molo Onlus, Turin, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Calati', 'Affiliation': 'Aphasia Experimental Laboratory-Fondazione Carlo Molo Onlus, Turin, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pia', 'Affiliation': 'Dipartimento di Psicologia, University of Turin, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'La Vista', 'Affiliation': 'Aphasia Experimental Laboratory-Fondazione Carlo Molo Onlus, Turin, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Molo', 'Affiliation': 'Aphasia Experimental Laboratory-Fondazione Carlo Molo Onlus, Turin, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rugiero', 'Affiliation': 'Aphasia Experimental Laboratory-Fondazione Carlo Molo Onlus, Turin, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fornaro', 'Affiliation': 'Aphasia Experimental Laboratory-Fondazione Carlo Molo Onlus, Turin, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marangolo', 'Affiliation': 'Aphasia Experimental Laboratory-Fondazione Carlo Molo Onlus, Turin, Italy.'}]",Behavioural neurology,['10.1155/2020/2846046']
1981,32831984,Effect of Preoperative Zoledronic Acid Administration on Pain Intensity after Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures.,"Introduction


This study aimed to compare and analyze the effect of preoperative zoledronic acid (ZOL) administration on pain intensity after percutaneous vertebroplasty (PVP) for osteoporotic vertebral compression fracture (OVCF).
Methods


The study included 242 patients with OVCFs who underwent PVP in our hospital between January 2015 and June 2018. The patients were randomly assigned to either a ZOL group ( n  = 121) or a control group ( n  = 121). The patients in the ZOL group were treated preoperatively with intravenous infusion of 5 mg ZOL. Those in the control group were treated without ZOL. All the patients were followed up for 1 year.
Results


No statistically significant differences in age, sex, weight, and body mass index (BMI) were found between the two groups. During the follow-up period, the visual analog scale score and Oswestry dysfunction index score in the ZOL group were lower than those in the control group. The bone mineral density at 6 or 12 months after treatment was significantly higher and the levels of the bone metabolism markers were significantly lower in the ZOL group than in the control group ( P  < 0.05 for both). Two patients in the treatment group had new vertebral fractures, whereas 13 patients in the control group had new vertebral fractures, which translate to recompression vertebral fracture incidence rates of 1.7% and 10.7%, respectively. The incidence rate of mild adverse reactions was significantly higher in the ZOL group than in the control group, but all the cases were endurable.
Conclusion


Intravenous infusion of ZOL before PVP can effectively reduce postoperative pain intensity, reduce bone loss, increase bone density, reduce the risk of refracture, and improve patient quality of life.",2020,"During the follow-up period, the visual analog scale score and Oswestry dysfunction index score in the ZOL group were lower than those in the control group.","['Osteoporotic Vertebral Compression Fractures', '242 patients with OVCFs who underwent PVP in our hospital between January 2015 and June 2018']","['Preoperative Zoledronic Acid Administration', 'preoperative zoledronic acid (ZOL', 'ZOL', 'percutaneous vertebroplasty (PVP', 'intravenous infusion of 5 mg ZOL']","['levels of the bone metabolism markers', 'bone mineral density', 'patient quality of life', 'recompression vertebral fracture incidence rates', 'Pain Intensity', 'pain intensity', 'new vertebral fractures', 'age, sex, weight, and body mass index (BMI', 'incidence rate of mild adverse reactions', 'visual analog scale score and Oswestry dysfunction index score', 'postoperative pain intensity, reduce bone loss, increase bone density']","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029464', 'cui_str': 'Osteosclerosis'}]",242.0,0.0169221,"During the follow-up period, the visual analog scale score and Oswestry dysfunction index score in the ZOL group were lower than those in the control group.","[{'ForeName': 'Weiran', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}, {'ForeName': 'Xinge', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}, {'ForeName': 'Yuepeng', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}, {'ForeName': 'Guangquan', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Xing', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}, {'ForeName': 'Yanzheng', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Spinal Cord Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan 45003, China.""}]",Pain research & management,['10.1155/2020/8039671']
1982,32832040,Effect of Amniotic Membrane Dressing on Pain and Healing of Palatal Donor Site: A Randomized Controlled Trial.,"Background


Free gingival graft is the most commonly practiced predictable technique for gingival augmentation.
Objective


To assess the effectiveness of human amniotic membrane, a biological dressing, on wound healing and post-operative pain after its application on the palatal donor site after free gingival graft surgery.
Methods


Of 27 eligible patients, 15 were randomized into a test group and received human amniotic membrane dressing sutured over their palatal donor site; 12 were randomized into a control group in whom the palatal donor site was only sutured. Standard clinical photographs were taken at 7, 14, and 21 days post-operatively and evaluated by 3 periodontists. The pain score at the donor site was assessed by a visual analog score; the number of analgesics taken was also recorded.
Results


The mean color match scores were higher in the test group than the control group at 14 (p<0.01) and 21 days after surgery (p=0.02). The difference in tissue texture (p=0.01) and inflammation (p=0.02) between the two groups was only significant on day 14 (p<0.05). The pattern of pain relief was better in the test group compared with the control group, especially in first days, although the differences were not significant in terms of the number of analgesics taken or the pain score.
Conclusion


Application of human amniotic membrane can accelerate wound healing and may decrease post-operative pain and discomfort by a limited amount.",2020,The mean color match scores were higher in the test group than the control group at 14 (p<0.01) and 21 days after surgery (p=0.02).,['27 eligible patients'],"['human amniotic membrane, a biological dressing', 'Amniotic Membrane Dressing', 'human amniotic membrane dressing sutured over their palatal donor site']","['Pain and Healing of Palatal Donor Site', 'mean color match scores', 'wound healing', 'tissue texture (p=0.01) and inflammation', 'pattern of pain relief', 'pain score', 'number of analgesics taken or the pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0005513', 'cui_str': 'Dressing, Biological'}, {'cui': 'C0002639', 'cui_str': 'Amniotic Membrane Dressings'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1286321', 'cui_str': 'Pattern of pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",27.0,0.0965404,The mean color match scores were higher in the test group than the control group at 14 (p<0.01) and 21 days after surgery (p=0.02).,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Kadkhoda', 'Affiliation': 'Associate Professor, Department of Periodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tavakoli', 'Affiliation': 'Assistant Professor, Iranian Tissue Bank Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chokami Rafiei', 'Affiliation': 'Assistant Professor, Department of Periodontics, School of Dentistry, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zolfaghari', 'Affiliation': 'Postgraduate Student, Department of Periodontics, School of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Akbari', 'Affiliation': 'Assistant Professor, Department of Periodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of organ transplantation medicine,[]
1983,32832098,"Problem-solving therapy rather than treatment as usual for adults after self-harm: a pragmatic, feasibility, randomised controlled trial (the MIDSHIPS trial).","Background


Non-fatal self-harm is one of the commonest reasons for adults' emergency hospital attendance. Although strongly associated with fatal and non-fatal repetition, there is weak evidence about effective interventions-and no clear NICE guidance or clinical consensus concerning aftercare. We examined the practicability of a definitive trial to evaluate problem-solving therapy (PST) to reduce repetition of self-harm; MIDSHIPS is a single-centre, parallel-group, individually randomised controlled feasibility trial comparing treatment-as-usual (TAU) alone to TAU plus up to six sessions of brief problem-solving therapy (PST) with adults who had recently attended hospital because of self-harm. Objectives were to adapt the intervention for a UK setting, train therapists, recruit and randomise patients, deliver PST under supervision, and establish comparative outcomes, assessed blindly.
Methods


We adapted the problem-solving intervention from an earlier trial and trained a mental-health nurse to deliver it. Adult patients attending the general hospital for self-harm were recruited while undergoing psychosocial assessment by the mental health team, and 62 were randomly allocated (32 TAU, 30 PST). The primary outcome assessed repeat hospital attendance due to further self-harm 6 months post-randomisation. Secondary outcomes included participant-reported outcomes and service use at 3 and 6 months post-randomisation.
Results


The recruitment period had to be extended and 710 patients screened in order to establish a trial sample of the planned size ( N  = 62). A quarter of participants allocated to PST did not undertake the therapy offered; those who received PST attended a median of three sessions. Secondary outcomes were established for 49 (79%) participants at 6 months; all participants' hospital records were retrieved. Repetition of self-harm leading to hospital presentation occurred in 19 of the 62 participants (30.6%, 95% CI 19.2%, 42.1%) within 6 months of randomisation. Promising differential rates of self-harm were observed with an event rate of 23.3% (95% CI 8.2%, 38.5%) in the PST arm; and 37.5% (95% CI 20.7%, 54.3%) in TAU. Economic findings were also encouraging, with a small QALY gain (0.0203) in the PST arm together with less reported use of the NHS in the PST arm (average £2120) than with TAU-only (£2878).
Conclusions


The feasibility trial achieved its objectives despite considerable difficulties with recruitment-adapting the PST, training a therapist, recruiting patients who had recently self-harmed, delivering the therapy, and establishing primary and secondary outcomes. These data provide a robust platform for a definitive multicentre randomised controlled trial of brief problem-solving therapy after hospital attendance due to self-harm.
Trial registration


Identification number and URL: ISRCTN54036115 http://www.isrctn.com/search?q=midships. Registered: 13 January 2012.",2020,"Promising differential rates of self-harm were observed with an event rate of 23.3% (95% CI 8.2%, 38.5%) in the PST arm; and 37.5% (95% CI 20.7%, 54.3%) in TAU.","['710 patients screened in order to establish a trial sample of the planned size ( N  = 62', 'Adult patients attending the general hospital for self-harm were recruited while undergoing psychosocial assessment by the mental health team, and 62 were randomly allocated (32 TAU, 30 PST', 'adults who had recently attended hospital because of self-harm', 'patients who had recently self-harmed, delivering the therapy, and establishing primary and secondary outcomes', ""adults' emergency hospital attendance""]","['URL', 'usual (TAU) alone to TAU plus up to six sessions of brief problem-solving therapy (PST', 'PST', 'problem-solving therapy (PST']","['repeat hospital attendance due to further self-harm 6\u2009months post-randomisation', 'participant-reported outcomes and service use at 3 and 6\u2009months post-randomisation', 'Repetition of self-harm leading to hospital presentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",,0.212657,"Promising differential rates of self-harm were observed with an event rate of 23.3% (95% CI 8.2%, 38.5%) in the PST arm; and 37.5% (95% CI 20.7%, 54.3%) in TAU.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Owens', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wright-Hughes', 'Affiliation': 'Leeds Institute of Clinical Trials Research, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Graham', 'Affiliation': 'Leeds Institute of Clinical Trials Research, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Blenkiron', 'Affiliation': 'Tees, Esk & Wear Valleys NHS Foundation Trust, West Park Hospital, Edward Pease Way, Darlington, DL2 2TS UK.'}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Burton', 'Affiliation': 'Leeds Institute of Clinical Trials Research, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Leeds Institute of Clinical Trials Research, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Leeds Institute of Clinical Trials Research, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hatcher', 'Affiliation': 'Department of Psychiatry, University of Ottawa, 1145 Carling Avenue, Ottawa, Ontario K1Z 7\u2009K4 Canada.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Tees, Esk & Wear Valleys NHS Foundation Trust, West Park Hospital, Edward Pease Way, Darlington, DL2 2TS UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Dwyer"", 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Pembroke', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Protheroe', 'Affiliation': 'Leeds and York Partnership NHS Foundation Trust, 2150 Century Way, Thorpe Park, Leeds, LS15 8ZB UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Tubeuf', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Leeds, LS2 9NL UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'House', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Leeds, LS2 9NL UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00668-0']
1984,32832985,Effects of an intervention to reduce fear of falling and increase physical activity during hip and pelvic fracture rehabilitation.,"BACKGROUND


fear of falling and reduced fall-related self-efficacy are frequent consequences of falls and associated with poorer rehabilitation outcomes. To address these psychological consequences, geriatric inpatient rehabilitation was augmented with a cognitive behavioural intervention (""Step by Step"") and evaluated in a RCT.
METHODS


one hundred fifteen hip and pelvic fracture patients (age = 82.5 years, 70% female) admitted to geriatric inpatient rehabilitation were randomly allocated to the intervention or control group. The intervention consisted of eight additional individual sessions during inpatient rehabilitation, one home visit and four telephone calls delivered over 2 months after discharge. Both groups received geriatric inpatient rehabilitation. Primary outcomes were fall-related self-efficacy (short falls efficacy scale-international) and physical activity as measured by daily walking duration (activPAL3™ sensor) after admission to rehabilitation, before discharge and 1-month post-intervention.
RESULTS


in covariance analyses, patients in the intervention group showed a significant improvement in fall-related self-efficacy (P = 0.025, d = -0.42), but no difference in total daily walking duration (P = 0.688, d = 0.07) 1-month post-intervention compared to the control condition. Further significant effects in favour of the intervention group were found in the secondary outcomes ""perceived ability to manage falls"" (P = 0.031, d = 0.41), ""physical performance"" (short physical performance battery) (P = 0.002, d = 0.58) and a lower ""number of falls"" (P = 0.029, d = -0.45).
CONCLUSIONS


the intervention improved psychological and physical performance measures but did not increase daily walking duration. For the inpatient part of the intervention further research on the required minimum intensity needed to be effective is of interest. Duration and components used to improve physical activity after discharge should be reconsidered.",2020,"RESULTS


in covariance analyses, patients in the intervention group showed a significant improvement in fall-related self-efficacy (P = 0.025, d = -0.42), but no difference in total daily walking duration (P = 0.688, d = 0.07) 1-month post-intervention compared to the control condition.","['one hundred fifteen hip and pelvic fracture patients (age\u2009=\u200982.5\xa0years, 70% female) admitted to geriatric inpatient rehabilitation', 'hip and pelvic fracture rehabilitation']","['geriatric inpatient rehabilitation', 'cognitive behavioural intervention (""Step by Step']","['fall-related self-efficacy (short falls efficacy scale-international) and physical activity as measured by daily walking duration (activPAL3™ sensor) after admission to rehabilitation, before discharge and 1-month post-intervention', 'psychological and physical performance measures', 'physical performance"" (short physical performance battery', 'fear of falling and increase physical activity', 'physical activity', 'daily walking duration', 'total daily walking duration', 'lower ""number of falls', 'secondary outcomes ""perceived ability to manage falls', 'fall-related self-efficacy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]",115.0,0.0170878,"RESULTS


in covariance analyses, patients in the intervention group showed a significant improvement in fall-related self-efficacy (P = 0.025, d = -0.42), but no difference in total daily walking duration (P = 0.688, d = 0.07) 1-month post-intervention compared to the control condition.","[{'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kampe', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Klenk', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Rapp', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Albrecht', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Büchele', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Eberhard Karls University, Tubingen, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Taraldsen', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}]",Age and ageing,['10.1093/ageing/afaa050']
1985,32833063,Reduced attentional capture by reward following an acute dose of alcohol.,"RATIONALE


Previous research has shown that physically salient and reward-related distractors can automatically capture attention and eye gaze in a visual search task, even though participants are motivated to ignore these stimuli.
OBJECTIVES


To examine whether an acute, low dose of alcohol would influence involuntary attentional capture by stimuli signalling reward.
METHODS


Participants were assigned to the alcohol or placebo group before completing a visual search task. Successful identification of the target earned either a low or high monetary reward but this reward was omitted if any eye gaze was registered on the reward-signalling distractor.
RESULTS


Participants who had consumed alcohol were significantly less likely than those in the placebo condition to have their attention captured by a distractor stimulus that signalled the availability of high reward. Analysis of saccade latencies suggested that this difference reflected a reduction in the likelihood of impulsive eye movements following alcohol.
CONCLUSIONS


Our findings suggest that alcohol intoxication reduces the capacity to attend to information in the environment that is not directly relevant to the task at hand. In the current task, this led to a performance benefit under alcohol, but in situations that require rapid responding to salient events, the effect on behaviour would be deleterious.",2020,"RESULTS


Participants who had consumed alcohol were significantly less likely than those in the placebo condition to have their attention captured by a distractor stimulus that signalled the availability of high reward.",['Participants'],['alcohol or placebo'],"['likelihood of impulsive eye movements', 'Reduced attentional capture']",[],"[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.267884,"RESULTS


Participants who had consumed alcohol were significantly less likely than those in the placebo condition to have their attention captured by a distractor stimulus that signalled the availability of high reward.","[{'ForeName': 'Poppy', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, 2052, Australia. poppy.watson@unsw.edu.au.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pearson', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Mike E', 'Initials': 'ME', 'LastName': 'Le Pelley', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, 2052, Australia.'}]",Psychopharmacology,['10.1007/s00213-020-05641-6']
1986,32833109,Cardiac arrhythmia catheter ablation procedures guided by x-ray imaging: N-acetylcysteine protection against radiation-induced cellular damage (CARAPACE study): study design.,"PURPOSE


Catheter ablation (CA) procedures are characterized by exposure to ionizing radiations (IR). IR can cause DNA damage and may lead to carcinogenesis if not efficiently repaired. The primary endpoint of this study is to investigate whether intravenous administration of N-acetylcysteine prior to CA procedure may prevent systemic oxidative stress and genomic DNA damage induced by exposure to IR.
METHODS


The ""Cardiac Arrhythmia catheter ablation procedures guided by x-Ray imaging: N-Acetylcysteine Protection Against radiation induced Cellular damagE"" (CARAPACE) study is a prospective, randomized, single-blinded, parallel-arm monocenter study enrolling 550 consecutive patients undergoing CA at the Arrhythmology Unit of Centro Cardiologico Monzino (CCM). Inclusion criteria are age ≥ 18, indication for CA procedure guided by IR imaging, and written informed consent. IR levels will be measured via fluoroscopy time, effective dose, and dose area product. Glutathione and glutathione disulfide concentrations will be measured, and urinary levels of 8-iso-prostaglandin-F 2α  and 8-hydroxy-2-deoxyguanosine will be quantified. The enrolled patients will be randomized 1:1 to the N-acetylcysteine group or to the control group.
RESULTS


We expect that pre-operative administration of N-acetylcysteine will prevent IR-induced systemic oxidative stress. The study will provide data on oxidative DNA damage assessed by urinary 8-hydroxy-2-deoxyguanosine levels and direct evidence of genomic DNA damage in blood cells by comet assay.
CONCLUSION


Catheter ablation procedures can lead to IR exposure and subsequent DNA damage. N-acetylcysteine administration prior to the procedure may prevent them and therefore lead to less possible complications.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT04154982).",2020,"The study will provide data on oxidative DNA damage assessed by urinary 8-hydroxy-2-deoxyguanosine levels and direct evidence of genomic DNA damage in blood cells by comet assay.
",['550 consecutive patients undergoing CA at the Arrhythmology Unit of Centro Cardiologico Monzino (CCM'],"['acetylcysteine group or to the control group', 'Arrhythmia catheter ablation procedures guided by x-Ray imaging: N-Acetylcysteine Protection Against radiation', 'Catheter ablation procedures', 'Catheter ablation (CA', 'Cardiac arrhythmia catheter ablation procedures guided by x-ray imaging: N-acetylcysteine protection']","['IR levels', 'Glutathione and glutathione disulfide concentrations', 'systemic oxidative stress and genomic DNA damage induced by exposure to IR']","[{'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0043299', 'cui_str': 'X-Ray, Diagnostic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0034538', 'cui_str': 'Ionizing radiation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",550.0,0.0496811,"The study will provide data on oxidative DNA damage assessed by urinary 8-hydroxy-2-deoxyguanosine levels and direct evidence of genomic DNA damage in blood cells by comet assay.
","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Catto', 'Affiliation': 'Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Stronati', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti"", Via Conca 71, Torrette (AN), 60126, Ancona, Italy. g.stronati@staff.univpm.it.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Porro', 'Affiliation': 'Unit of Metabolomics and Cellular Biochemistry of Atherothrombosis, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Fiorelli', 'Affiliation': 'Unit of Metabolomics and Cellular Biochemistry of Atherothrombosis, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Ricci', 'Affiliation': 'Unit of Immunology and Functional Genomics, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Vavassori', 'Affiliation': 'Unit of Immunology and Functional Genomics, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Russo', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Surgery, Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Guerra', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti"", Via Conca 71, Torrette (AN), 60126, Ancona, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Gasperetti', 'Affiliation': 'Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ribatti', 'Affiliation': 'Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Sicuso', 'Affiliation': 'Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Russo', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti"", Via Conca 71, Torrette (AN), 60126, Ancona, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Veglia', 'Affiliation': 'Unit of Biostatistics, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Tondo', 'Affiliation': 'Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Cavalca', 'Affiliation': 'Unit of Metabolomics and Cellular Biochemistry of Atherothrombosis, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Gualtiero I', 'Initials': 'GI', 'LastName': 'Colombo', 'Affiliation': 'Unit of Immunology and Functional Genomics, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tremoli', 'Affiliation': 'Centro Cardiologico Monzino IRCCS, 20138, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casella', 'Affiliation': 'Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-020-00853-4']
1987,32833128,Influence of Prenatal Aerobic Exercise on Fetal Morphometry.,"OBJECTIVE


The purpose of this study was to determine the effects of supervised prenatal aerobic exercise on fetal morphometrics at 36 weeks of gestation.
METHODS


This study used data from a, 24-week, two-arm randomized controlled trial: aerobic exercise (EX) and stretching/breathing comparison group (CON). Singleton pregnancies (< 16 weeks pregnant) and women aged 18 to 40 years, BMI between 18.5 and 34.99 kg/m 2 , and no preexisting chronic health conditions were eligible. The EX group participated in 150 min of moderate-intensity weekly exercise while CON group participated in low-intensity stretching/breathing. Fetal morphometric outcomes included estimated fetal weight (EFW), ponderal index (PI), abdominal circumference (AC), anterior abdominal wall thickness (AAWT), fat mass, percent body fat, fat-free mass, assessed at 36 weeks gestation. Partial spearman rank correlations were performed, adjusting for 3 rd  trimester weight gain.
RESULTS


Of the 128 pregnant women randomized, 83 (EX [n = 46] and CON [n = 37]) were eligible for analyses. Intention-to-treat analysis showed no differences in EFW (rho s  = - 0.13; p = 0.28), PI (rho s  = 0.03; p = 0.81), AC (rho s  = - 0.22; p = 0.09), AAWT (rho s  = - 0.11; p = 0.40), fat mass (rho s  = - 0.16; p = 0.23), percent body fat (rho s  = - 0.10; p = 0.43), and fat-free mass (rho s  = - 0.22; p = 0.08), after adjusting for 3rd trimester weight gain. Similar results were observed in the per protocol analyses.
CONCLUSIONS


For Practice Moderate-intensity aerobic exercise during pregnancy was not associated with select fetal morphometrics at 36 weeks gestation. Potential differences in offspring morphometrics may only appear in the postnatal period, as previously documented. Further research into offspring tissue composition after birth is encouraged, specifically studies investigating differences in cellular signaling pathways related to adipose and skeletal muscle tissue development.",2020,"Intention-to-treat analysis showed no differences in EFW (rho s  = - 0.13; p = 0.28), PI (","['128 pregnant women randomized, 83 (EX [n\u2009=\u200946] and CON [n\u2009=\u200937]) were eligible for analyses', 'Singleton pregnancies (<\u200916\xa0weeks pregnant) and women aged 18 to 40\xa0years, BMI between 18.5 and 34.99\xa0kg/m 2 , and no preexisting chronic health conditions were eligible']","['supervised prenatal aerobic exercise', 'moderate-intensity weekly exercise while CON group participated in low-intensity stretching/breathing', 'aerobic exercise (EX) and stretching/breathing comparison group (CON', 'Prenatal Aerobic Exercise']","['EFW', 'Fetal Morphometry', 'fat mass', 'fetal morphometrics', 'percent body fat', 'estimated fetal weight (EFW), ponderal index (PI), abdominal circumference (AC), anterior abdominal wall thickness (AAWT), fat mass, percent body fat, fat-free mass']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0230193', 'cui_str': 'Anterior abdominal wall structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",128.0,0.191963,"Intention-to-treat analysis showed no differences in EFW (rho s  = - 0.13; p = 0.28), PI (","[{'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'McDonald', 'Affiliation': 'Department of Foundational Science and Research, ECU, 1851 MacGregor Downs Rd, Greenville, NC, 27834, USA.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Newton', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Strickland', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Isler', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Haven', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kelley', 'Affiliation': 'Department of Biostatistics, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chasan-Taber', 'Affiliation': 'Department of Biostatistics & Epidemiology, University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kuehn', 'Affiliation': 'Department of Clinical Pediatrics, ECU, Greenville, NC, USA.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'May', 'Affiliation': 'Department of Foundational Science and Research, ECU, 1851 MacGregor Downs Rd, Greenville, NC, 27834, USA. mayl@ecu.edu.'}]",Maternal and child health journal,['10.1007/s10995-020-03000-7']
1988,32833133,Postoperative effects of intra-alveolar application of 0.2% chlorhexidine or 1% hyaluronic acid bioadhesive gels after mandibular third molar extraction: a double-blind randomized controlled clinical trial.,"OBJECTIVE


The aim of this study was to analyze the postoperative effects of intra-alveolar applications of 0.2% chlorhexidine (CHL) or 1% hyaluronic (HA) acid bioadhesive gels following the extraction of mandibular impacted third molars (MITMs).
MATERIALS AND METHODS


In this double-blind randomized controlled clinical trial, 90 patients with one asymptomatic MITM were randomized into three group (n = 30 per group): group 1 (0.2% CHL), group 2 (1% HA), and group 3 (control). Visual analogue scales (VAS) were used to assess postoperative pain 24, 48, and 72 h and 7 days after surgery. Postsurgical complications were recorded: trismus, alveolitis osteitis, infection, or hematoma.
RESULTS


In order from least to greatest, postoperative pain at all evaluation times was 0.2% CHL < 1% HA < control. At 24 h, statistically significant differences were found between both study groups and the control groups (0.2% CHL/control: P = 0.001; 1% HA/control: P = 0.010). At 48 and 72 h, significant differences were only found between 0.2% CHL and the control group (P = 0.229 and P = 0.046, respectively). At 7 days, no significant differences were found between any groups. Comparing the incidence of postoperative trismus, alveolitis osteitis, infection, or hematoma, although complications were more frequent in the control group, no statistical differences between groups were found (P > 0.050).
CONCLUSIONS


Both 0.2% CHL and 1% HA bioadhesive gels applied intra-alveolarly minimize the postoperative complications after MITM extraction. Further research is necessary to confirm the present results.
CLINICAL RELEVANCE


This study might help to reduce the postsurgical complications in patients after MITM extraction.",2020,"At 24 h, statistically significant differences were found between both study groups and the control groups (0.2% CHL/control: P = 0.001; 1% HA/control: P = 0.010).","['after mandibular third molar extraction', '90 patients with one asymptomatic MITM', 'patients after MITM extraction', 'mandibular impacted third molars (MITMs']","['chlorhexidine or 1% hyaluronic acid bioadhesive gels', 'chlorhexidine (CHL) or 1% hyaluronic (HA) acid bioadhesive']","['Visual analogue scales (VAS', 'postoperative complications', 'postsurgical complications', 'Postsurgical complications', 'trismus, alveolitis osteitis, infection, or hematoma', 'postoperative trismus, alveolitis osteitis, infection, or hematoma, although complications', 'postoperative pain']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0549493', 'cui_str': 'Alveolitis'}, {'cui': 'C0029400', 'cui_str': 'Osteitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",90.0,0.220021,"At 24 h, statistically significant differences were found between both study groups and the control groups (0.2% CHL/control: P = 0.001; 1% HA/control: P = 0.010).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Muñoz-Cámara', 'Affiliation': ', Murcia, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pardo-Zamora', 'Affiliation': 'Department of Integral Dentistry, University of Murcia, Murcia, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Camacho-Alonso', 'Affiliation': 'Department of Oral Surgery, University of Murcia, Murcia, Spain. fcamacho@um.es.'}]",Clinical oral investigations,['10.1007/s00784-020-03522-y']
1989,32833136,"Efficacy of the eribulin, pertuzumab, and trastuzumab combination therapy for human epidermal growth factor receptor 2-positive advanced or metastatic breast cancer: a multicenter, single arm, phase II study (JBCRG-M03 study).","Purpose To date, it is not clear which anticancer agent is useful in combination with trastuzumab and pertuzumab As the first and second selective regimens for advanced or metastatic breast cancer (AMBC), this multicenter, open-label, phase II trial (JBCRG-M03: UMIN000012232) presents a prespecified analysis of eribulin in combination with pertuzumab and trastuzumab. Methods We enrolled 50 patients with no or single prior chemotherapy for HER2-positive AMBC during November 2013-April 2016. All patients received adjuvant or first-line chemotherapy with trastuzumab and a taxane. The treatment comprised eribulin on days 1 and 8 of a 21-day cycle and trastuzumabplus pertuzumab once every 3 weeks, all administered intravenously. While the primary endpoint was the progression-free survival (PFS), secondary endpoints were the response rate and safety. Results Of 50 patients, 49 were eligible for safety analysis, and the full analysis set (FAS) included 46 patients. We treated 8 (16%) and 41 (84%) patients in first- and second-line settings, respectively. While 11 patients (23.9%) had advanced disease, 35 (76.1%) had metastatic disease. The median PFS was 9.2 months for all patients [95% confidence interval (CI): 7.0-11.4]. In the FAS, 44 patients had the measurable lesions and the complete response rate (CR) was 17.4%, and partial response rate (PR) was 43.5%. The grade 3/4 adverse events were neutropenia (5 patients, 10.2%), including febrile neutropenia (2 patients, 4.1%), hypertension (3 patients, 6.1%), and other (1 patient). The average of the left ventricular ejection fraction did not decline markedly. No symptomatic left ventricular systolic dysfunction was observed. Conclusions In patients with HER2-positive AMBC, eribulin, pertuzumab, and trastuzumab combination therapy exhibited substantial antitumor activity with an acceptable safety profile. Hence, we have started a randomized phase III study comparing eribulin and a taxane in combination with pertuzumab and trastuzumab for the treatment of HER2-positive AMBC. Trial registration ID: UMIN-CTR: UMIN000012232.",2020,"The grade 3/4 adverse events were neutropenia (5 patients, 10.2%), including febrile neutropenia (2 patients, 4.1%), hypertension (3 patients, 6.1%), and other (1 patient).","['human epidermal growth factor receptor 2-positive advanced or metastatic breast cancer', 'advanced or metastatic breast cancer (AMBC', '50 patients, 49 were eligible for safety analysis, and the full analysis set (FAS) included 46 patients', '50 patients with no or single prior chemotherapy for HER2-positive AMBC during November 2013-April 2016', 'HER2-positive AMBC']","['taxane', 'adjuvant or first-line chemotherapy with trastuzumab and a taxane', 'eribulin, pertuzumab, and trastuzumab combination therapy', 'pertuzumab and trastuzumab']","['febrile neutropenia', 'metastatic disease', 'complete response rate (CR', 'advanced disease', 'partial response rate (PR', 'symptomatic left ventricular systolic dysfunction', 'average of the left ventricular ejection fraction', 'response rate and safety', 'neutropenia', 'hypertension', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",50.0,0.0720979,"The grade 3/4 adverse events were neutropenia (5 patients, 10.2%), including febrile neutropenia (2 patients, 4.1%), hypertension (3 patients, 6.1%), and other (1 patient).","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama, 241-8515, Japan. tyamashita@kcch.jp.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Breast Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kitada', 'Affiliation': 'Breast Disease Center, Asahikawa Medical University Hospital, Asahikawa, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Narui', 'Affiliation': 'Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Hattori', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Yoshinami', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Nobuki', 'Initials': 'N', 'LastName': 'Matsunami', 'Affiliation': 'Department of Breast Surgery, Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yanagihara', 'Affiliation': 'Department of Medical Oncology, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Teru', 'Initials': 'T', 'LastName': 'Kawasoe', 'Affiliation': 'Department of Breast and Endocrine Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagashima', 'Affiliation': 'Department of General Surgery, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yano', 'Affiliation': 'Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Breast Surgery, Hirosaki Municipal Hospital, Hirosaki, Japan.'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Department of Breast Surgery, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kashiwaba', 'Affiliation': 'Breast Surgery, Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Center of Breast Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Surgery (Breast Surgery), Graduate School of Medicine Kyoto University, Kyoto, Japan.'}]",Investigational new drugs,['10.1007/s10637-020-00991-6']
1990,32833167,Don't Invite Everyone! Training Variables Impacting the Effectiveness of QPR Trainings.,"Gatekeeper trainings have been increasingly utilized in response to rising suicide rates in youths. However, the extent to which common factors inherent to gatekeeper trainings impact training outcomes is largely understudied. As such, the present study explored how factors such as training size and trainer engagement abilities influenced trainee participation and outcomes (i.e. changes in attitudes, perceived behavioral control (PBC), and knowledge regarding suicide prevention). All trainees participated in a gatekeeper training; trainers were not randomly assigned. Mediation and moderation analyses were completed using the PROCESS macro for SPSS (Hayes in Introduction to mediation, moderation, and conditional process analysis: a regression-based approach, Guilford Press, New York, 2013). Trainee participation in a training was examined as a mediator of the relationship between the training size and training outcomes, while trainer engagement was examined as a moderator of the relationship between size of training and trainee participation. Size of training was significantly related to lower changes in participant knowledge, along with lower trainee participation in gatekeeper trainings. Trainee participation significantly mediated the relationship between size of training, attitudes, and PBC. Additionally, trainer engagement significantly moderated the association between size of training and trainee participation. The results of this study suggest that general gatekeeper training-related variables may influence participant outcomes, specifically through trainee participation.",2020,"Size of training was significantly related to lower changes in participant knowledge, along with lower trainee participation in gatekeeper trainings.",['All trainees participated in a gatekeeper training; trainers'],['Gatekeeper trainings'],"['size of training, attitudes, and PBC']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}]",,0.016592,"Size of training was significantly related to lower changes in participant knowledge, along with lower trainee participation in gatekeeper trainings.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of South Florida, Tampa, USA. amandayeager@mail.usf.edu.'}, {'ForeName': 'Maureen F', 'Initials': 'MF', 'LastName': 'Monahan', 'Affiliation': 'University of South Florida, Tampa, USA.'}, {'ForeName': 'Ansley M', 'Initials': 'AM', 'LastName': 'Bender', 'Affiliation': 'University of South Florida, Tampa, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Gryglewicz', 'Affiliation': 'University of Central Florida, Orlando, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Karver', 'Affiliation': 'University of South Florida, Tampa, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01078-3']
1991,32833285,Susceptibility-guided quadruple therapy is not superior to medication history-guided therapy for the rescue treatment of Helicobacter pylori infection: a randomized controlled trial.,"AIM


Personalized regimens are increasingly emphasized for the rescue treatment of Helicobacter pylori (H. pylori) infection. This study aims to compare the efficacy of two personalized rescue therapies.
METHODS


An open-label, single-center, randomized controlled trial was conducted. Patients with1-2 regimen failures were randomized to receive an antimicrobial susceptibility testing (AST) or personal medication history (PMH)-guided 14-day bismuth quadruple therapy. In AST group, two sensitive antibiotics were prescribed according to susceptibility test results. In PMH group, amoxicillin plus either levofloxacin or furazolidone were prescribed based on quinolones history. The primary outcomes were eradication rates confirmed by urea breath test at 6 weeks after treatment. The secondary outcomes were adherence, incidence of adverse events (AEs) and cost-effectiveness analysis (ClincialTrials.gov, number NCT03658746).
RESULTS


A total of 420 patients were recruited and randomized, 164 patients with positive culture received AST-guided therapy, 192 patients received PMH-guided therapy. Both AST and PMH-guided therapies achieved comparable efficacies with intention-to-treat eradication rates of 78.10% vs. 74.29% (P=0.42), per-protocol eradication rates of 87.10% vs. 88.64% (P=0.80). Notably, susceptibility-guided clarithromycin regimen showed a lower per-protocol eradication rate as compared to levofloxacin (75.47% vs. 96.30%, P=0.03) or furazolidone containing regimen (75.47% vs. 92.75%, P=0.02). Both groups had high adherence with low incidences of AEs. PMH-guided therapy yielded a lower cost-effectiveness analysis ratio over AST-guided therapy.
CONCLUSION


AST-guided therapy was not superior to PMH-guided therapy as a second or third-line treatment for H. pylori infection. Considering the cost-effectiveness, PMH-guided therapy is clinically more favorable with lower cost and non-invasive convenience. This article is protected by copyright. All rights reserved.",2020,"PMH-guided therapy yielded a lower cost-effectiveness analysis ratio over AST-guided therapy.
","['Patients with1-2 regimen failures', 'Helicobacter pylori infection', '420 patients were recruited and randomized, 164 patients with positive culture received AST-guided therapy, 192 patients received']","['levofloxacin or furazolidone', 'levofloxacin', 'amoxicillin', 'Susceptibility-guided quadruple therapy', 'antimicrobial susceptibility testing (AST) or personal medication history (PMH)-guided 14-day bismuth quadruple therapy', 'clarithromycin', 'furazolidone', 'PMH-guided therapy', 'AST-guided therapy']","['per-protocol eradication rates', 'efficacies with intention-to-treat eradication rates', 'lower per-protocol eradication rate', 'adherence, incidence of adverse events (AEs) and cost-effectiveness analysis (ClincialTrials.gov, number NCT03658746', 'eradication rates confirmed by urea breath test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0427965', 'cui_str': 'Antimicrobial susceptibility - finding'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517623', 'cui_str': '192'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0427965', 'cui_str': 'Antimicrobial susceptibility - finding'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}]",420.0,0.0953708,"PMH-guided therapy yielded a lower cost-effectiveness analysis ratio over AST-guided therapy.
","[{'ForeName': 'Chao-Ran', 'Initials': 'CR', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yue-Yue', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Qiao', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Qu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Jun-Nan', 'Initials': 'JN', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Min-Juan', 'Initials': 'MJ', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Li-Xiang', 'Initials': 'LX', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Zuo', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yan-Qing', 'Initials': 'YQ', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheloo College of Medicine, Shandong University, Jinan, Shandong Province, China.'}]",Journal of digestive diseases,['10.1111/1751-2980.12934']
1992,32833291,"Single-session Comprehend, Cope, and Connect intervention in acute and crisis psychology: A feasibility and acceptability study.","Comprehend, Cope and Connect (CCC) is a third-wave cognitive behavioural approach developed for acute mental health services. The aim of this study was to assess feasibility and acceptability of a newly-developed, manualised single-session CCC intervention delivered face-to-face with service users in acute and crisis psychology services in South London. The study adopted a within-subjects pre-post-test design. Participants (N=23) were recruited from five acute psychiatric wards and a crisis resolution home treatment team. Service users had a range of diagnoses of complex and severe mental health conditions, in particular mood, personality, and psychotic disorders. Feasibility data was gathered for number of times the CCC formulation was accepted, duration of CCC intervention, clinician adherence to manualised protocol, and frequency of goal-based activity completion. Acceptability data on pre- and post-CCC mood and post-CCC helpfulness were self-reported by participants. Findings indicated a significant increase in positive mood (large effect) and moderate-high helpfulness rating post-intervention. Most participants reported goal-based activity completion. There was high fidelity to the protocol, high percentage of acceptance of the formulation and formulation components completed, and frequent single-session completion. Single-session CCC appears feasible and acceptable in acute and crisis psychology services and yields formulation-driven goal-based activities intended to stabilise mental health crisis. High fidelity to formulation protocol suggests broader applications for single-session CCC, e.g. to support clinical staff to manage crisis situations in their work environment or to train non-psychologist clinicians to deliver the intervention for service users. A randomised-controlled trial of single-session CCC would increase validity and generalisability of findings.",2020,"Comprehend, Cope and Connect (CCC) is a third-wave cognitive behavioural approach developed for acute mental health services.","['Service users had a range of diagnoses of complex and severe mental health conditions, in particular mood, personality, and psychotic disorders', 'Participants (N=23) were recruited from five acute psychiatric wards and a crisis resolution home treatment team', 'acute and crisis psychology', 'service users in acute and crisis psychology services in South London']","['Cope and Connect (CCC', 'single-session CCC', 'manualised single-session CCC intervention', 'Connect intervention']","['Acceptability data on pre- and post-CCC mood and post-CCC helpfulness', 'positive mood (large effect) and moderate-high helpfulness rating', 'goal-based activity completion', 'feasibility and acceptability', 'duration of CCC intervention, clinician adherence to manualised protocol, and frequency of goal-based activity completion']","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0587654', 'cui_str': 'Psychology service'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",23.0,0.0901442,"Comprehend, Cope and Connect (CCC) is a third-wave cognitive behavioural approach developed for acute mental health services.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bullock', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Kent, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Whiteley', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Kent, United Kingdom.'}, {'ForeName': 'Kaylee', 'Initials': 'K', 'LastName': 'Moakes', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Kent, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Clarke', 'Affiliation': 'Southern Health NHS Foundation Trust, Tatchbury Mount, Calmore, Southampton, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Riches', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Kent, United Kingdom.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2505']
1993,32828115,A pilot study into bosentan (Tracleer®) as an immunomodulating agent in patients with Behçet's disease.,"BACKGROUND


Behçet's disease (BD) is an auto-inflammatory vasculitis characterized by aphthous oro-genital ulcers, inflammatory skin changes and uveitis. Treatment is mainly immunosuppressive. Interestingly, elevated endotheline-1 (ET-1) levels suggest a possible beneficial effect of treatment with an ET-1 receptor antagonist.
OBJECTIVE


The aim of our study was to investigate the possible beneficial effect of the ET-1 inhibitor bosentan.
METHODS


We performed a prospective double-blind placebo controlled pilot study into the effect and safety of bosentan in BD patients. Disease activity was measured using the Behçet Disease Current Activity Form. The primary objective of the study was to determine whether bosentan is therapeutically effective in patients with BD. Secondary endpoints were safety, tapering of medication and the effect of bosentan on possible disease activity markers such as ET-1, circulating endothelial cells (CECs), soluble interleukin-2 receptor (sIL2R) and cytokine levels.
RESULTS


Ten patients were randomized to either bosentan or placebo. Overall, no effect on disease activity was observed, although one patient responded clinically and continued treatment after the study period. Despite one SAE, bosentan seems safe to use. No effect on tapering of medication, CECs, sIL2R and cytokine levels was found. In the bosentan group, ET-1 levels were elevated during the treatment period, with no correlation with disease activity.
CONCLUSIONS


Although this is a small pilot study, bosentan appears to be safe in BD patients. One patient had a durable and significant clinical response. Our observations should be confirmed and extended in a larger patient cohort to be of significant impact in the treatment options for BD.",2020,"In the bosentan group, ET-1 levels were elevated during the treatment period, with no correlation with disease activity.
","[""patients with Behçet's disease"", 'patients with BD', 'BD patients']","['bosentan (Tracleer®', 'bosentan or placebo', 'placebo', 'ET-1 inhibitor bosentan']","['disease activity', 'Disease activity', 'elevated endotheline-1 (ET-1) levels', 'ET-1 levels', 'tapering of medication, CECs, sIL2R and cytokine levels', 'safety, tapering of medication and the effect of bosentan on possible disease activity markers such as ET-1, circulating endothelial cells (CECs), soluble interleukin-2 receptor (sIL2R) and cytokine levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004943', 'cui_str': ""Behcet's syndrome""}]","[{'cui': 'C0252643', 'cui_str': 'bosentan'}, {'cui': 'C1101331', 'cui_str': 'Tracleer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0487019', 'cui_str': 'Interleukin 2 receptor, soluble'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0252643', 'cui_str': 'bosentan'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",10.0,0.103821,"In the bosentan group, ET-1 levels were elevated during the treatment period, with no correlation with disease activity.
","[{'ForeName': 'Tim B van der', 'Initials': 'TBV', 'LastName': 'Houwen', 'Affiliation': 'Department of Immunology, Section Clinical Immunology, Erasmus University Medical Center, Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'P Martin van', 'Initials': 'PMV', 'LastName': 'Hagen', 'Affiliation': 'Department of Immunology, Section Clinical Immunology, Erasmus University Medical Center, Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Jasper H', 'Initials': 'JH', 'LastName': 'Kappen', 'Affiliation': 'Allergy and Clinical Immunology, Immunomodulation and Tolerance Group, National Heart and Lung Institute, Inflammation Repair and Development, Imperial College, London, United Kingdom; Department of Pulmonology, STZ Centre of Excellence for Asthma & COPD, Franciscus group, Rotterdam, United Kingdom.'}, {'ForeName': 'Robert W A M', 'Initials': 'RWAM', 'LastName': 'Kuijpers', 'Affiliation': 'Department of Ophthalmology, Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Paul L A van', 'Initials': 'PLAV', 'LastName': 'Daele', 'Affiliation': 'Department of Immunology, Section Clinical Immunology, Erasmus University Medical Center, Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Wim A van', 'Initials': 'WAV', 'LastName': 'Dik', 'Affiliation': 'Department of Immunology, Section Clinical Immunology, Erasmus University Medical Center, Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Wim A van', 'Initials': 'WAV', 'LastName': 'Dik', 'Affiliation': 'Department of Immunology, Section Clinical Immunology, Erasmus University Medical Center, Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Jan A M van', 'Initials': 'JAMV', 'LastName': 'Laar', 'Affiliation': 'Department of Immunology, Section Clinical Immunology, Erasmus University Medical Center, Rotterdam, Rotterdam, the Netherlands.'}]",Asian Pacific journal of allergy and immunology,['10.12932/AP-160919-0648']
1994,32828116,The effect of vitamin D add-on therapy on the improvement of quality of life and clinical symptoms of patients with chronic spontaneous urticaria.,"BACKGROUND


Chronic urticaria is a common distressing allergic skin disorder. Immune dysregulation, histamine release and mast cell degranulation are suggested as its underlying mechanisms.
OBJECTIVE


Add-on therapy of vitamin D was evaluated in patients with chronic spontaneous urticaria to determine the quality of life and urticaria severity score.
METHODS


In a prospective, double-blinded study, 80 participants with chronic spontaneous urticaria were randomized to low (4200 IU/week, group 1) and high (28,000 IU/week, group 2) vitamin D3 supplementation groups for 12 weeks. Demographic data; quality of life, urticaria severity and medication scores; 25-hydroxyvitamin D and anti-thyroid peroxidase antibody levels; and autologous serum skin test data were collected.
RESULTS


Both groups showed significantly reduced total urticaria severity score; decrement in group 2 score was significant compared to group 1 at week 6 (P = 0.010). Quality of life score was also significantly reduced; decrement in group 2 score was significant compared to group 1 at both weeks 6 (P = 0.005) and 12 (P = 0.007). 25-hydroxyvitamin D levels were elevated significantly over the course of 12 weeks in both groups; however, the elevation in group 2 was significantly higher than group 1 at week 12 (P = 0.002). Medication score was significantly reduced, with no significant difference between groups. No association was observed between positive autologous serum skin test, angioedema and high level of Anti thyroperoxidase antibody with positive response to vitamin D.
CONCLUSIONS


Add-on therapy with vitamin D (28,000 IU/week) can be considered as a safe and potentially beneficial treatment in patients with chronic spontaneous urticaria.",2020,decrement in group 2 score was significant compared to group 1 at both weeks 6 (P = 0.005) and 12 (P = 0.007).,"['80 participants with chronic spontaneous urticaria', 'patients with chronic spontaneous urticaria']","['vitamin D3 supplementation', '25-hydroxyvitamin', 'vitamin D']","['quality of life and urticaria severity score', 'positive autologous serum skin test, angioedema', 'quality of life and clinical symptoms', 'Demographic data; quality of life, urticaria severity and medication scores; 25-hydroxyvitamin D and anti-thyroid peroxidase antibody levels; and autologous serum skin test data', 'Medication score', 'Quality of life score', 'total urticaria severity score', 'D levels']","[{'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0076635', 'cui_str': 'Thyroid microsomal antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",80.0,0.0403739,decrement in group 2 score was significant compared to group 1 at both weeks 6 (P = 0.005) and 12 (P = 0.007).,"[{'ForeName': 'Seyed Hesamedin', 'Initials': 'SH', 'LastName': 'Nabavizadeh', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Alyasin', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Mosavat', 'Affiliation': 'Department of Allergy and Clinical Immunology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Ebrahimi', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Asian Pacific journal of allergy and immunology,['10.12932/AP-021219-0705']
1995,32828117,"A randomized, double-blind, placebo-controlled trial on the effect of intranasal corticosteroid as a treatment for moderate to severe obstructive sleep apnea with coexisting chronic rhinitis.","BACKGROUND


Chronic rhinitis is a common co-existing disease with obstructive sleep apnea (OSA). Current evidence on intranasal steroid efficacy as a treatment modality is scarce.
OBJECTIVE


This study assessed the efficacy of intranasal steroid in moderate to severe OSA with coexisting chronic rhinitis.
METHODS


A prospective randomized, double-blind, placebo-controlled trial was conducted in non-2nd to 3rd degree obese, non-severe oropharyngeal obstruction, moderate to severe OSA with coexisting chronic rhinitis (total nasal symptom score (TNSS) ≥ 6, BMI < 30 kg/m2, modified Mallampati < 3). We randomized the patients to receive intranasal steroid (fluticasone furoate, 110 mcg/day) or placebo for one-month duration. The primary end point was the change in apnea hypopnea index (AHI).
RESULTS


A total of 34 patients were randomly assigned to receive intranasal steroid (N = 18) or placebo (N = 16). The adjusted absolute difference mean change of AHI did not show significant difference (11.5 ± 7.9 events/hour [95% CI; -4.9 to 27.8; p = 0.16]). Interestingly, significant reduction in non-supine respiratory disturbance index (RDI) (56.1 ± 21.9 events/hour [95% CI; 18.9 to 93.2; p = 0.01]) was observed in intranasal steroid group. When comparison was made within group, only intranasal steroid group demonstrated significant reduction in AHI, RDI, NREM RDI, TNSS, and Thai Pittsburgh sleep quality index (p = 0.02, 0.02, 0.01, 0.003, and < 0.001; respectively) after receiving the drug.
CONCLUSIONS


In moderate to severe OSA patients with coexisting chronic rhinitis, intranasal steroid demonstrated significant reduction in obstructive respiratory events during non-supine sleep. Intranasal steroid may be considered as adjunctive or alternative to OSA treatment.",2020,"In moderate to severe OSA patients with coexisting chronic rhinitis, intranasal steroid demonstrated significant reduction in obstructive respiratory events during non-supine sleep.","['34 patients', 'severe OSA patients with coexisting chronic rhinitis', 'moderate to severe obstructive sleep apnea with coexisting chronic rhinitis', 'moderate to severe OSA with coexisting chronic rhinitis', 'non-2nd to 3rd degree obese, non-severe oropharyngeal obstruction, moderate to severe OSA with coexisting chronic rhinitis (total nasal symptom score (TNSS) ≥ 6, BMI < 30 kg/m2, modified Mallampati < 3', 'obstructive sleep apnea (OSA']","['intranasal steroid (fluticasone furoate', 'Intranasal steroid', 'intranasal corticosteroid', 'placebo', 'intranasal steroid']","['intranasal steroid efficacy', 'obstructive respiratory events', 'non-supine respiratory disturbance index (RDI', 'change in apnea hypopnea index (AHI', 'AHI, RDI, NREM RDI, TNSS, and Thai Pittsburgh sleep quality index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",34.0,0.156767,"In moderate to severe OSA patients with coexisting chronic rhinitis, intranasal steroid demonstrated significant reduction in obstructive respiratory events during non-supine sleep.","[{'ForeName': 'Vorakamol', 'Initials': 'V', 'LastName': 'Phoophiboon', 'Affiliation': 'Division of Pulmonary and Critical Care medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Dittapol', 'Initials': 'D', 'LastName': 'Muntham', 'Affiliation': 'Section for Mathematics, Faculty of Science and Technology, Rajamangala University of Technology Suvarnabhumi, Phranakhon Si Ayutthaya, Thailand.'}, {'ForeName': 'Naricha', 'Initials': 'N', 'LastName': 'Chirakalwasan', 'Affiliation': 'Division of Pulmonary and Critical Care medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Asian Pacific journal of allergy and immunology,['10.12932/AP-070320-0785']
1996,32828129,"Correction to: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection: A structured summary of a study protocol for a randomized controlled trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['newly diagnosed patients with COVID-19 infection'],"['Hydroxychloroquine, Oseltamivir and Azithromycin']",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],,0.12893,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Akram', 'Affiliation': 'Vice Chancellor/Professor of Internal Medicine, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Shehnoor', 'Initials': 'S', 'LastName': 'Azhar', 'Affiliation': 'Assistant Professor Public Health, University of Health Sciences, Lahore, Pakistan. shehnoor.azhar@gmail.com.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shahzad', 'Affiliation': 'Professor of Pharmacology, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Latif', 'Affiliation': 'Data Analyst at University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Distinguished Investigator at Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}]",Trials,['10.1186/s13063-020-04697-1']
1997,32828130,"Does a ketogenic diet have beneficial effects on quality of life, physical activity or biomarkers in patients with breast cancer: a randomized controlled clinical trial.","INTRODUCTION


Despite recent interest in the use of ketogenic diets (KDs) for cancer, evidence of beneficial effects is lacking. This study examined the impact of a randomly assigned KD on quality of life, physical activity and biomarkers in patients with breast cancer.
METHOD


A total of 80 patients with locally advanced or metastatic breast cancer and without a history of renal disease or diabetes were randomly assigned to either a KD or a control group for this 12-week trial. Concurrent with the first, third, and fifth chemotherapy sessions, quality of life, physical activity, and biomarkers (thyroid function tests, electrolytes, albumin, ammonia, ALP, lactate and serum ketones) were assessed. Dietary intake was also recorded on admission and the end of the treatment.
RESULTS


No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P = 0.02 P = 0.01). Also, serum lactate and ALP levels decreased significantly in the KD group compared to the control group at the end of the intervention (10.7 ± 3 vs 13.3 ± 4, 149 ± 71 vs 240 ± 164, P = 0.02 and P = 0.007, respectively). A significant inverse association was observed between total carbohydrate intake and serum beta-hydroxybutyrate at 12 weeks (r = - 0.77 P < 0.001). No significant differences between groups were observed in thyroid hormones, electrolytes, albumin, LDH or ammonia. Compliance among KD subjects ranged from 66.7 to 79.2% as assessed by dietary intake and serum ketones levels of > 0.5.
CONCLUSION


According to our results, besides a higher global quality of life and physical activity scores compared to the control group at 6 weeks, KD diet combined to chemotherapy in patients with breast cancer does not bring additional benefit about quality of life and physical activity at 12 weeks. However, decreases seen in levels of lactate and ALP in the KD group suggest that a KD may benefit patients with breast cancer.
TRIAL REGISTRATION


This trial has been registered on Iranian Registry of Clinical Trials (IRCT) under the identification code: IRCT20171105037259N2 https://www.irct.ir/trial/30755.",2020,"No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P = 0.02 P = 0.01).","['80 patients with locally advanced or metastatic breast cancer and without a history of renal disease or diabetes', 'patients with breast cancer']","['KD', 'KD diet combined to chemotherapy']","['serum lactate and ALP levels', 'levels of lactate and ALP', 'quality of life, physical activity or biomarkers', 'total carbohydrate intake and serum beta-hydroxybutyrate', 'thyroid hormones, electrolytes, albumin, LDH or ammonia', 'quality of life or physical activity scores', 'Dietary intake', 'quality of life, physical activity, and biomarkers (thyroid function tests, electrolytes, albumin, ammonia, ALP, lactate and serum ketones', 'quality of life, physical activity and biomarkers', 'dietary intake and serum ketones levels', 'global quality of life and physical activity scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0455686', 'cui_str': 'H/O: kidney disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0040130', 'cui_str': 'Thyroid panel'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C1303221', 'cui_str': 'Serum ketone level'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",80.0,0.0266931,"No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P = 0.02 P = 0.01).","[{'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Khodabakhshi', 'Affiliation': 'Department of Nutrition, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Seyfried', 'Affiliation': 'Biology Department, Boston College, Chestnut Hill, MA, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kalamian', 'Affiliation': 'Dietary Therapies LLC, Hamilton, MT, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Beheshti', 'Affiliation': ""Department of Nutrition and Dietetics, Mofid children's hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Sayed Hossein', 'Initials': 'SH', 'LastName': 'Davoodi', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. khodabakhshiadeleh@yahoo.com.'}]",Nutrition journal,['10.1186/s12937-020-00596-y']
1998,32828135,Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.,"The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical ventilation ( P  = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.",2020,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","['patients with COVID-19', 'COVID-19', 'three major university hospitals in Egypt', 'One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent']","['HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group', 'Hydroxychloroquine', 'hydroxychloroquine (HCQ', 'HCQ']","['mechanical ventilation', 'mortality rates', 'safety and efficacy', 'recovery within 28 days, need for mechanical ventilation, or death', 'overall mortality', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",194.0,0.126559,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Eslam Saber', 'Initials': 'ES', 'LastName': 'Esmail', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Khalaf', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ehab Fawzy', 'Initials': 'EF', 'LastName': 'Abdo', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Medhat', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Samir', 'Initials': 'MS', 'LastName': 'Abd El Ghafar', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ossama Ashraf', 'Initials': 'OA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public Health and Community Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ghada N', 'Initials': 'GN', 'LastName': 'Serangawy', 'Affiliation': 'Department of Forensic Medicine and Toxicology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alboraie', 'Affiliation': 'Department of Internal Medicine, Al-Azhar University, Cairo, Egypt.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0873']
1999,32828167,"Effectiveness of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal: a cluster randomised trial in Pakistan.","BACKGROUND


Maternal depression has a recurring course that can influence offspring outcomes. Evidence on how to treat maternal depression to improve longer-term maternal outcomes and reduce intergenerational transmission of psychopathology is scarce, particularly for task-shifted, low-intensity, and scalable psychosocial interventions. We evaluated the effects of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal.
METHODS


40 village clusters in Pakistan were randomly allocated using a computerised randomisation sequence to receive a group-based, psychosocial intervention and enhanced usual care for 36 months, or enhanced usual care alone. Pregnant women (≥18 years) were screened for moderate or severe symptoms of depression (patient health questionnaire-9 [PHQ-9] score ≥10) and were recruited into the trial (570 participants), and a cohort without depression (PHQ-9 score <10) was also enrolled (584 participants). Including the non-depressed dyads enabled us to determine how much of the excess risk due to maternal depression exposure the intervention could mitigate. Research teams responsible for identifying, obtaining consent, and recruiting trial participants were blind to the allocation status throughout the duration of the study, and principal investigators, site coordinators, statisticians, and members of the trial steering committee were also blinded to the allocation status until the analysis of 6-month data for the intervention. Primary outcomes were maternal depression symptoms and remission (PHQ-9 score <10) and child socioemotional skills (strengths and difficulties questionnaire [SDQ-TD]) at 36-months postnatal. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02658994.
FINDINGS


From Oct 15, 2014 to Feb 25, 2016 46 village clusters were assessed for eligibility, of which 40 (including 1910 mothers were enrolled. After exclusions, 288 women were randomly assigned to the enhanced usual care group and 284 to the intervention group, and 1159 women were included in a group without prenatal depression. At 36-months postnatal, complete data were available from 889 mother-child dyads: 206 (72·5%) in the intervention group, 216 (75·3%) in the enhanced usual care group, and 467 (80·0%) women who did not have prenatal-depression. We did not observe significant outcome differences between the intervention group and the enhanced usual care group for the primary outcomes. The standardised mean difference of PHQ-9 total score was -0·13 (95% CI -0·33 to 0·07), relative risk of patient health questionnaire-9 remission was 1·00 (95% CI 0·88 to 1·14), and the SDQ-TD treatment estimate was -0·10 (95% CI -1·39 to 1·19).
INTERPRETATION


Reduced symptom severity and high remission rates were seen across both the intervention and enhanced usual care groups, possibly masking any effects of the intervention. A multi-year, psychosocial intervention can be task-shifted via peers but might be susceptible to reductions in fidelity and dosage over time (which were not among the outcomes of this trial). Early intervention efforts might need to rely on multiple models (eg, collaborative care), be of greater intensity, and potentially targeted at mothers who are at high risk for depression to reduce the intergenerational transmission of psychopathology from mothers to children.
FUNDING


National Institutes of Health.",2020,"Reduced symptom severity and high remission rates were seen across both the intervention and enhanced usual care groups, possibly masking any effects of the intervention.","['PHQ-9] score ≥10) and were recruited into the trial (570 participants), and a cohort without depression (PHQ-9 score <10) was also enrolled (584 participants', '46 village clusters were assessed for eligibility, of which 40 (including 1910 mothers were enrolled', 'Pregnant women (≥18 years) were screened for moderate or severe symptoms of depression (patient health questionnaire-9', '40 village clusters in Pakistan', '889 mother-child dyads: 206 (72·5%) in the intervention group, 216 (75·3%) in the enhanced usual care group, and 467 (80·0%) women who did not have prenatal-depression', '288 women were randomly assigned to the enhanced usual care group and 284 to the intervention group, and 1159 women were included in a group without prenatal depression']","['peer-delivered, psychosocial intervention', 'psychosocial intervention and enhanced usual care for 36 months, or enhanced usual care alone']","['symptom severity and high remission rates', 'relative risk of patient health questionnaire-9 remission', 'maternal depression and child development', 'PHQ-9 total score', 'maternal depression symptoms and remission (PHQ-9 score <10) and child socioemotional skills (strengths and difficulties questionnaire [SDQ-TD']","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",288.0,0.131877,"Reduced symptom severity and high remission rates were seen across both the intervention and enhanced usual care groups, possibly masking any effects of the intervention.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Maselko', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: jmaselko@unc.edu.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan; Health Services Academy, Islamabad, Pakistan.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bates', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ikhlaq', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Najia', 'Initials': 'N', 'LastName': 'Atif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Baranov', 'Affiliation': 'Department of Economics, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bhalotra', 'Affiliation': 'Department of Economics, University of Essex, Colchester, UK.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Tayyaba', 'Initials': 'T', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Bilal', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Biroli', 'Affiliation': 'Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Chung', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Hagaman', 'Affiliation': 'Department of Social and Behavioral Sciences, Yale School of Public Health, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'LeMasters', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Donnell"", 'Affiliation': 'Center for Child and Family Health, Durham, NC, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Scherer', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Research Triangle International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sharif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Waqas', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaidi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Shaffaq', 'Initials': 'S', 'LastName': 'Zulfiqar', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30258-3']
2000,32828187,"The Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials in Mozambique, Pakistan, and India: an individual participant-level meta-analysis.","BACKGROUND


To overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries.
METHODS


In this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014-17. Consenting pregnant women, aged 12-49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564.
FINDINGS


Overall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22-30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90-1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
INTERPRETATION


The CLIP intervention did not reduce adverse pregnancy outcomes. Future community-level interventions should expand the community health worker workforce, assess general (rather than condition-specific) messaging, and include health system strengthening.
FUNDING


University of British Columbia, a grantee of the Bill & Melinda Gates Foundation.",2020,"No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
","['6990 group and 16\u2008691 home-based community engagement sessions and 138\u2008347 community health worker-led visits to 20\u2008819 (57·8%) of 36\u2008008 women (of whom 11\u2008095', 'for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia', '1255', '44 clusters (69\u2008330 pregnant women', 'consenting participants who were followed up with completed pregnancies at trial end', '6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral', 'Median maternal age of included women was 26 years (IQR 22-30', 'women with pregnancy hypertension in three low-income countries', 'Consenting pregnant women, aged 12-49 years, were recruited in their homes']","['intramuscular magnesium sulfate', 'community-level interventions targeting', 'community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension', 'magnesium sulfate', 'CLIP intervention', 'methyldopa']","['composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby', 'adverse pregnancy outcomes', 'adverse effects', 'Blood pressure and dipstick proteinuria', 'control clusters', 'severe hypertension', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019982', 'cui_str': 'Referral to hospital'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",69330.0,0.274918,"No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada. Electronic address: pvd@kcl.ac.uk.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, Toronto, ON, Canada; Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Mrutyunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': 'KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': 'KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, Hanagal Shree Kumareshwar Hospital and Research Centre, Bagalkote, Karnataka, India.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça, Manhiça, Mozambique; Department of Physiological Sciences, Clinical Pharmacology, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça, Manhiça, Mozambique.'}, {'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Physiological Sciences, Clinical Pharmacology, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31128-4']
2001,32828349,Effectiveness of nurses training in routine screening of violence against women with mental illness: A randomized controlled trail.,"BACKGROUND


Globally, people with mental illness are highly vulnerable to various forms of abuse. Yet, research on routine screening of violence by mental health professionals is limited.
AIM


The aim of this study was to evaluate the impact of training on nurses' attitudes towards routine screening and confidence in implementing routine screening of violence among women with mental illness.
METHODS


A randomized controlled trial design was adopted for the present study. The participants of this study were 68 nurses randomly assigned to either experimental or control group (34 in each group). The experimental group was provided eight interactive sessions based on a Nursing Module on abuse among women with mental illness. The assessments were done in both groups at baseline, after the intervention, at three months and at six months. All assessments were self-rated questionnaires to assess nurses' attitudes and confidence in implementing routine screening of violence attitudes.
RESULTS


The experimental group showed a statistically significant improvement in the attitudes and confidence in implementing routine screening of abuse in women with mental illness (p < 0.05) than the control group. Repeated measures of analysis also revealed statistically significant differences related to attitude and confidence in implementing routine screening of abuse between the groups and within the experimental group at different time points of assessment (p < 0.001).
CONCLUSION


This study concluded that training based on a nursing module improved nurses' attitudes and confidence to conduct routine screening of violence among women with mental illness. However, further studies are necessary to clarify whether the training is effective in implementing in nursing practice.",2020,"Repeated measures of analysis also revealed statistically significant differences related to attitude and confidence in implementing routine screening of abuse between the groups and within the experimental group at different time points of assessment (p < 0.001).
","['people with mental illness', 'on abuse among women with mental illness', 'routine screening of violence against women with mental illness', 'women with mental illness']","['interactive sessions based on a Nursing Module', 'nurses training']","['attitudes and confidence in implementing routine screening of abuse in women with mental illness', 'attitude and confidence in implementing routine screening of abuse']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",68.0,0.0776145,"Repeated measures of analysis also revealed statistically significant differences related to attitude and confidence in implementing routine screening of abuse between the groups and within the experimental group at different time points of assessment (p < 0.001).
","[{'ForeName': 'Vijayalakshmi', 'Initials': 'V', 'LastName': 'Poreddi', 'Affiliation': 'College of Nursing, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India. Electronic address: pvijayalakshmireddy@gmail.com.'}, {'ForeName': 'Sailaxmi', 'Initials': 'S', 'LastName': 'Gandhi', 'Affiliation': 'Department of Nursing, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India.'}, {'ForeName': 'Sai Nikhil', 'Initials': 'SN', 'LastName': 'Reddy', 'Affiliation': 'Bangalore Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Marimuthu', 'Initials': 'M', 'LastName': 'Palaniappan', 'Affiliation': 'Department of Bio-statistics, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'BadaMath', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.05.003']
2002,32828351,"Effects of psychological intervention for Korean infertile women under In Vitro Fertilization on infertility stress, depression, intimacy, sexual satisfaction and fatigue.","This quasi-experimental study with a nonequivalent control group pretest-posttest design was conducted to evaluate the effects of a psychological intervention program for 50 women with infertility (experimental group: 26, control group: 24) utilizing assisted reproductive technology. The experimental group received six four-hour sessions of intervention, with outcomes measured at baseline and four weeks post-intervention. The experimental group demonstrated significant improvements in marital intimacy (z = 6.528, p < .001) and sexual satisfaction (z = 3.148, p = .003) and significant reductions in depression (z = -4.850, p < .001) and fatigue (z = -4.597, p < .001). Thus, the program can alleviate depression and fatigue. Further, psychological intervention centered on the marital and personal dimensions may improve marital intimacy and sexual satisfaction.",2020,"The experimental group demonstrated significant improvements in marital intimacy (z = 6.528, p < .001) and sexual satisfaction (z = 3.148, p = .003) and significant reductions in depression (z = -4.850, p < .001) and fatigue (z = -4.597, p < .001).","['Korean infertile women under', '50 women with infertility (experimental group: 26, control group: 24']","['psychological intervention program', 'psychological intervention', 'utilizing assisted reproductive technology']","['marital intimacy and sexual satisfaction', 'sexual satisfaction', 'infertility stress, depression, intimacy, sexual satisfaction and fatigue', 'marital intimacy', 'fatigue', 'depression']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",50.0,0.0201846,"The experimental group demonstrated significant improvements in marital intimacy (z = 6.528, p < .001) and sexual satisfaction (z = 3.148, p = .003) and significant reductions in depression (z = -4.850, p < .001) and fatigue (z = -4.597, p < .001).","[{'ForeName': 'Miok', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dankook University, Dandae-ro 119, Cheonan 31116, Chungnam, South Korea. Electronic address: aprilsea@hanmail.net.'}, {'ForeName': 'So-Hyun', 'Initials': 'SH', 'LastName': 'Moon', 'Affiliation': 'Department of Nursing, College of Medicine, Chosun University, Pilmundae-ro 309, Dong-gu, Gwangju 61452, South Korea. Electronic address: shmoon@chosun.ac.kr.'}, {'ForeName': 'Jee-Ean', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': ""Department of Early Childhood Education, Baewha Women's University, Pirundaero 1-gil 34, Jongno-gu, Seoul 03039, South Korea. Electronic address: 10105@baewha.ac.kr.""}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.05.001']
2003,32828358,The effect of behavioral parent training on sleep problems of school-age children with ADHD: A parallel randomized controlled trial.,"OBJECTIVE


The aim of this study was to examine the effect of behavioral parental training (BPT) on sleep problems in children diagnosed with ADHD.
METHODS


This parallel randomized controlled trial was conducted in a psychiatric clinic in an urban area of Iran. Participants of this study were 58 school-age children who were diagnosed with ADHD, were receiving methylphenidate and had at least one problem in sleeping. They were randomly assigned into BPT or control groups. Participants' parents in the BPT group underwent a 5-week behavioral intervention program. Data were collected at baseline, immediately after the intervention, and two months after the intervention. Data were analyzed using Chi-square, Fisher's exact test, independent sample t-test, and repeated measure ANOVA test via the SPSS software.
RESULTS


Children in the intervention group experienced a significant improvement in total sleep scores two months after the intervention compared to the control group (p = 0.03). Also, the findings showed a significant decline in total sleep problems in the intervention group compared to the control group over time (p = 0.01).
CONCLUSION


The results suggest that BPT could be an effective method in improving sleep problems of school-age children diagnosed with ADHD undergoing methylphenidate treatment.",2020,"RESULTS


Children in the intervention group experienced a significant improvement in total sleep scores two months after the intervention compared to the control group (p = 0.03).","['children diagnosed with ADHD', 'Participants of this study were 58 school-age children who were diagnosed with ADHD, were receiving methylphenidate and had at least one problem in sleeping', 'sleep problems of school-age children with ADHD', ""Participants' parents in the BPT group underwent a"", 'school-age children diagnosed with ADHD undergoing methylphenidate treatment', 'psychiatric clinic in an urban area of Iran']","['behavioral parent training', '5-week behavioral intervention program', 'BPT', 'behavioral parental training (BPT']","['total sleep problems', 'sleep problems', 'total sleep scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",58.0,0.113286,"RESULTS


Children in the intervention group experienced a significant improvement in total sleep scores two months after the intervention compared to the control group (p = 0.03).","[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Mehri', 'Affiliation': 'Department of Paediatric Nursing, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Minoo Mitra', 'Initials': 'MM', 'LastName': 'Chehrzad', 'Affiliation': 'Department of Paediatric Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mardani', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.. Electronic address: maleki@shmu.ac.ir.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Dianatinasab', 'Affiliation': 'Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kousha', 'Affiliation': 'Department of Epidemiology, Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assari', 'Affiliation': 'Department of Family Medicine, Charles R Drew University of Medicine and science, Los Angeles, CA, USA.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.04.001']
2004,32828570,The Effect of a Personalized Newsletter to Physical Therapists on Patient Recruitment: A Cluster Randomized Trial in Primary Physiotherapy Care.,"OBJECTIVE


To assess the effect of a personalized newsletter compared with a standard newsletter on patient recruitment in physiotherapy research.
METHODS


We performed a cluster-randomized trial including 120 physiotherapists who recruited patients for a prospective cohort and were randomly assigned to either receiving personalized feedback in a newsletter (intervention group) or a standard newsletter (control group). We calculated the difference in the number of patients included in the study corrected for inclusion time between both groups.
RESULTS


The physiotherapists in the control group (n = 59) included 110 patients (35.4% of the total number of patients included) compared with an inclusion of 200 patients (64.6% of the total number of patients included) by the physiotherapists in the intervention group (n = 61), a difference of 90 patients in favor of the intervention group. However, when corrected for inclusion time and a cluster effect, we found no statistically significant difference between both groups. In addition, therapists who did not include a single patient (inactive therapists) were evenly divided between the 2 groups (n = 29 [49%] in the control group; n = 30 [49%] in the intervention group).
CONCLUSIONS


A personalized newsletter does not significantly increase the number of recruited patients by physiotherapists. However, therapists receiving personalized feedback recruited nearly double the number of patients compared with the ones receiving standard feedback.",2020,"However, when corrected for inclusion time and a cluster effect, we found no statistically significant difference between both groups.","['Patient Recruitment', '120 physiotherapists who recruited patients for a prospective cohort']","['personalized feedback in a newsletter (intervention group) or a standard newsletter (control group', 'Personalized Newsletter to Physical Therapists']",[],"[{'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]",[],120.0,0.0950398,"However, when corrected for inclusion time and a cluster effect, we found no statistically significant difference between both groups.","[{'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Thoomes-de Graaf', 'Affiliation': 'Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands; Research Group Diagnostics, Avans University of Applied Science, Breda, Netherlands. Electronic address: marloesthoomes@me.com.'}, {'ForeName': 'Rienke E', 'Initials': 'RE', 'LastName': 'Wiersma', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Yasmaine', 'Initials': 'Y', 'LastName': 'Karel', 'Affiliation': 'Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands; Research Group Diagnostics, Avans University of Applied Science, Breda, Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Duijn', 'Affiliation': 'Research Group Diagnostics, Avans University of Applied Science, Breda, Netherlands.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Spek', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Rizopoulos', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gwendolijne G M', 'Initials': 'GGM', 'LastName': 'Scholten-Peeters', 'Affiliation': 'Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Arianne P', 'Initials': 'AP', 'LastName': 'Verhagen', 'Affiliation': 'Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands; Department of Physiotherapy, Graduate School of Health University of Technology Sydney, Sydney, Australia.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.12.002']
2005,32828644,An investigation of the effects of an anger management psychoeducation programme on psychological resilience and affect of intensive care nurses.,"BACKGROUND


It is known that intensive care nurses experience stressful events more frequently than nurses working in other units. Experiencing stressful events frequently may reduce the psychological resilience of intensive care nurses and cause them to express their tension and negative emotions as anger. However, nurses' failure to manage their anger may also lead to medical errors and adversely affect the quality of healthcare services.
PURPOSE


This study aims to investigate the effects of an anger management psychoeducation programme on psychological resilience and affect of intensive care nurses.
METHODS


Using a self-controlled design, this study was conducted with nurses working in a tertiary intensive care unit of a private hospital in Turkey. The participants were randomly and equally distributed to the study group (n = 16) and the control group (n = 16). The participants in the study group attended an eight-week anger management psychoeducation programme, while those in the control group did not. The Psychological Resilience Scale for Adults (RSA) and Positive and Negative Affect Scale (PANAS) were applied to both groups as pre-test and post-test. In addition, one month after the post-test, RSA and PANAS were administered again to determine the stability of the impact of the psychoeducation program on the participants.
RESULTS


No significant change over time was observed in the scores of the control group from the overall scale (all ıntra-group comparison p-values > 0.05), while a significant change over time was observed in the scores of the study group from the overall scale (all ıntra-group comparison p-values < 0.001). Although it was observed that both groups' positive affect scores changed over time (both ıntra-group comparison p-values < 0.05), the paired comparison revealed that the scores of the control group were similar. On the other hand, it was observed that the study group's positive effect scores increased significantly after the psychoeducation programme but remained similar in the follow-up period. Furthermore, only the study group's negative affect scores decreased over time, this decrease continued in the follow-up period.
CONCLUSIONS


The study concludes that the anger management psychoeducation programme affected the psychological resilience and emotional state of intensive care nurses.",2020,"No significant change over time was observed in the scores of the control group from the overall scale (all ıntra-group comparison p-values > 0.05), while a significant change over time was observed in the scores of the study group from the overall scale (all ıntra-group comparison p-values < 0.001).","['intensive care nurses', 'nurses working in a tertiary intensive care unit of a private hospital in Turkey']","['RSA and PANAS', 'eight-week anger management psychoeducation programme', 'anger management psychoeducation programme']","['psychological resilience', 'psychological resilience and emotional state', 'positive effect scores', 'overall scale', 'Psychological Resilience Scale for Adults (RSA) and Positive and Negative Affect Scale (PANAS']","[{'cui': 'C0586960', 'cui_str': 'Intensive therapy nurse'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0557992', 'cui_str': 'Anger management therapy'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",16.0,0.0226905,"No significant change over time was observed in the scores of the control group from the overall scale (all ıntra-group comparison p-values > 0.05), while a significant change over time was observed in the scores of the study group from the overall scale (all ıntra-group comparison p-values < 0.001).","[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Turan', 'Affiliation': 'Nursing Department, Ufuk University, Ankara, Turkey. Electronic address: deniz-nazan@hotmail.com.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102915']
2006,32828663,Harnessing Augmented Reality and CT to Teach First-Year Medical Students Head and Neck Anatomy.,"RATIONALE AND OBJECTIVES


Three-dimensional (3D) visualization has been shown to benefit new generations of medical students and physicians-in-training in a variety of contexts. However, there is limited research directly comparing student performance after using 3Dtools to those using two-dimensional (2D) screens.
MATERIALS AND METHODS


A CT was performed on a donated cadaver and a 3D CT hologram was created. A total of 30 first-year medical students were randomly assigned into two groups to review head and neck anatomy in a teaching session that incorporated CT. The first group used an augmented reality headset, while the second group used a laptop screen. The students were administered a five-question anatomy test before and after the session. Two-tailed t-tests were used for statistical comparison of pretest and posttest performance within and between groups. A feedback survey was distributed for qualitative data.
RESULTS


Pretest vs. posttest comparison of average percentage of questions answered correctly demonstrated both groups showing significant in-group improvement (p < 0.05), from 59% to 95% in the augmented reality group, and from 57% to 80% in the screen group. Between-group analysis indicated that posttest performance was significantly better in the augmented reality group (p = 0.022, effect size = 0.73).
CONCLUSION


Immersive 3D visualization has the potential to improve short-term anatomic recall in the head and neck compared to traditional 2D screen-based review, as well as engage millennial learners to learn better in anatomy laboratory. Our findings may reflect additional benefit gained from the stereoscopic depth cues present in augmented reality-based visualization.",2020,"Immersive 3D visualization has the potential to improve short-term anatomic recall in the head and neck compared to traditional 2D screen-based review, as well as engage millennial learners to learn better in anatomy laboratory.",['A total of 30 first-year medical students'],"['augmented reality headset, while the second group used a laptop screen', 'Harnessing Augmented Reality and CT', 'teaching session that incorporated CT']",['posttest performance'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],,0.0188048,"Immersive 3D visualization has the potential to improve short-term anatomic recall in the head and neck compared to traditional 2D screen-based review, as well as engage millennial learners to learn better in anatomy laboratory.","[{'ForeName': 'Joanna K', 'Initials': 'JK', 'LastName': 'Weeks', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Pakpoor', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA.'}, {'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Robinson', 'Affiliation': 'Department of Cell and Developmental Biology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Neal A', 'Initials': 'NA', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Cell and Developmental Biology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Prouty', 'Affiliation': 'Department of Cell and Developmental Biology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Arun C', 'Initials': 'AC', 'LastName': 'Nachiappan', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA. Electronic address: arun.nachiappan@pennmedicine.upenn.edu.'}]",Academic radiology,['10.1016/j.acra.2020.07.008']
2007,32828678,Features predicting treatment failure in pediatric acute otitis media.,"OBJECTIVES


To facilitate better antibiotic stewardship, we conducted this clinical trial to identify the prognostic features of treatment failure in pediatric acute otitis media (AOM).
STUDY


Design: This is a randomized, parallel-group, open-label, comparative clinical trial.
SUBJECTS AND METHODS


Children with AOM and aged between 1 month and 5 years were enrolled. Patients were randomly assigned to receive either amoxicillin alone (70 mg/kg) for five days, or the same with additional clarithromycin (15 mg/kg) for the initial three days. The clinical course of AOM was evaluated based on tympanic membrane scores. Failure of treatment for AOM was confirmed on day 14. Nasal conditions were also assessed by a clinical scoring system for acute rhinosinusitis.
RESULTS


Treatment failures occurred in 25 out of 129 (19.4%) children. The ratio of treatment failures by age was significantly higher in children younger than 2 years than in children older than 2 years. The tympanic membrane scores on day 3 (P = 0.0334) and day 5 (P < 0.0001) and acute rhinosinusitis scores on day 5 (P = 0.0004) were higher in failure cases than in cured cases. Multivariate logistic regression analysis indicated significant associations between the treatment failure with tympanic membrane scores and acute rhinosinusitis scores on day 5, and the antimicrobial treatment regimen.
CONCLUSIONS


Improvement of acute rhinosinusitis and tympanic membrane scores on day five were important predictive features in failure of treatment for pediatric AOM. These results will be useful when discussing the treatment decisions with the patient's parents.",2020,The ratio of treatment failures by age was significantly higher in children younger than 2 years than in children older than 2 years.,"['Children with AOM and aged between 1 month and 5 years were enrolled', 'pediatric acute otitis media', 'pediatric acute otitis media (AOM']","['clarithromycin', 'amoxicillin alone']","['tympanic membrane scores and acute rhinosinusitis scores', 'acute rhinosinusitis and tympanic membrane scores', 'tympanic membrane scores', 'acute rhinosinusitis scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2317131', 'cui_str': 'Acute rhinosinusitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",129.0,0.0719061,The ratio of treatment failures by age was significantly higher in children younger than 2 years than in children older than 2 years.,"[{'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Kono', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama-shi, Wakayama 641-8510, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Fukushima', 'Affiliation': 'Department of Dermatology & Otolaryngology, Hayashima Clinic, 1475-2 Hayashima, Hayashima-cho, Tokubo-gun, Okayama, 701-0304, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kamide', 'Affiliation': 'Kamide ENT Clinic, 2433-4 Denbou, Fuji-shi, Shizuoka 417-0061, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kunimoto', 'Affiliation': 'Kunimoto ENT Clinic, 5769-7 Tomo Aza Oohara, Numata-cho, Asa Minami-ku, Hiroshima -shi, Hiroshima 731-3161, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Matsubara', 'Affiliation': 'Matsubara ORL Clinic, 100 Ikeda-cho, Seki-shi, Gifu 501-3247, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Sawada', 'Affiliation': 'Sawada Eye and Ear Clinic, 1734-5 Fukui-cho, Kochi-shi, Kochi, 780-0965, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Shintani', 'Affiliation': 'Tomo ENT Clinic, 1-246 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido 060-8611, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Togawa', 'Affiliation': 'Sunsun Clinic, 569-1 Nogawa, Wakayama-shi, Wakayama 640-8481, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Uchizono', 'Affiliation': 'Sendai ENT Clinic, 1945-1 Taki-cho, Satsuma Sendai-shi, Kagoshima 895-0211, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Uno', 'Affiliation': 'Uno ENT Clinic, 3702-4 Kita Tomihara, Okayama-shi, Okayama, 701-1153, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamanaka', 'Affiliation': 'Moriya Keiyu Hospital, 980-1 Tachizawa, Moriya-shi, Ibaraki, 302-0118, Japan.'}, {'ForeName': 'Muneki', 'Initials': 'M', 'LastName': 'Hotomi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama-shi, Wakayama 641-8510, Japan. Electronic address: mhotomi@wakayama-med.ac.jp.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2020.08.003']
2008,32828682,Does intraoperative penile tourniquet application during hypospadias repair affect the patients and surgeons reported outcomes? A randomized controlled trial.,"BACKGROUND


Hemostasis aimed to maintain the bloodless surgical field for better exposure for the surgeon. There are no trials regarding the impact of hemostasis techniques for hypospadias surgery on surgeon satisfaction and patients' reported outcomes. Application of penile tourniquet is a common practice in hypospadias surgery that aims at reducing blood loss and improving visualization. Yet, scarce data exist on the effect of penile tourniquet on hypospadias repair outcomes.
PURPOSE


To evaluate the safety and efficacy of restraining penile perfusion using a tourniquet in hypospadias repair on the surgical outcome, also surgeons and patients reported outcomes. To evaluate the effect of penile tourniquet application on hypospadias repair outcome and surgeon's satisfaction with intraoperative hemostasis.
STUDY DESIGN


In this single-blinded randomized controlled trial, a total of 110 children with distal hypospadias amenable for TIP repair were assigned to hypospadias repair with or without intraoperative application of a penile tourniquet. Surgeries were performed by a junior (2-5 years of experience in TIP repair) or a senior pediatric urologist (with >5 years of experience). Intraoperative blood loss, the number of times bipolar diathermy was used, hemoglobin deficit, and operative time were compared. Surgeon's satisfaction with intraoperative hemostasis was evaluated using a 4-tiered questionnaire. Patients were followed up for a minimum of one year. Complications and readmission rates were compared. The patient-reported outcome of hypospadias repair was assessed using the hypospadias objective scoring evaluation (HOSE).
RESULTS


Baseline patient demographics and hypospadias characteristics were comparable between the study groups. Bipolar diathermy was more often used in the non-tourniquet group (mean ± SD = 5.7 ± 1.8 times vs. 6.7 ± 1.9 for the tourniquet group; p = 0.007). Also, the operative time was longer in non-tourniquet group [mean = 54.7 ± 14.9 vs. 60.8 ± 12.5 min (p = 0.028)]. Junior surgeons were more likely to be satisfied with hemostasis when a tourniquet was used (97.4% vs. 79.5%, p = 0.02). Postoperative complications, readmission rates, and patient-reported outcomes were similar between both groups.
CONCLUSION


The application of penile tourniquet during hypospadias repair can reduce operative time and the need for diathermy use; and also improves junior surgeon's satisfaction with intraoperative hemostasis without adversely affecting success rates or patient-reported outcomes.",2020,"Postoperative complications, readmission rates, and patient-reported outcomes were similar between both groups.
",['110 children with distal hypospadias amenable for TIP repair'],"['intraoperative penile tourniquet application', 'penile tourniquet application', 'hypospadias repair with or without intraoperative application of a penile tourniquet', 'penile tourniquet', 'Bipolar diathermy', 'restraining penile perfusion']","['operative time', 'safety and efficacy', 'hypospadias objective scoring evaluation (HOSE', 'Complications and readmission rates', 'hemoglobin deficit, and operative time', 'hypospadias repair', 'Intraoperative blood loss, the number of times bipolar diathermy', 'Postoperative complications, readmission rates, and patient-reported outcomes', 'blood loss and improving visualization']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet'}, {'cui': 'C0558337', 'cui_str': 'Hypospadias repair'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0441520', 'cui_str': 'Bipolar diathermy'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0558337', 'cui_str': 'Hypospadias repair'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0441520', 'cui_str': 'Bipolar diathermy'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",110.0,0.281258,"Postoperative complications, readmission rates, and patient-reported outcomes were similar between both groups.
","[{'ForeName': 'Tamer E', 'Initials': 'TE', 'LastName': 'Helmy', 'Affiliation': 'Department of Pediatric Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abdelwahab', 'Initials': 'A', 'LastName': 'Hashem', 'Affiliation': 'Department of Pediatric Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt. Electronic address: abdelwahab_hashem@yahoo.com.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mursi', 'Affiliation': 'Department of Pediatric Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'AbdelHalim', 'Affiliation': 'Department of Pediatric Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Hafez', 'Affiliation': 'Department of Pediatric Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Dawaba', 'Affiliation': 'Department of Pediatric Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.07.044']
2009,32828683,Therapeutic effects of desmopressin in primary monosymptomatic noctural enuresis treatment depending on Patients'Age.,"PURPOSE


To test the therapeutic effects of Desmopressin (dDAVP) in primary monosymptomatic nocturnal enuresis (PMNE) treatment depending on patients'age.
MATERIAL AND METHODS


The prospective research was carried out in the 2014-2018 period, during which 89 patients were observed who were treated with dDAVP due to the previously diagnosed PMNE. The patients were divided into two age groups. The first group (Group 1) consisted of 43 patients age 5 to 6, with the average age of 5.6 ± 0.5, out of whom 35 (81.4%) were boys, and 8 (18.6%) girls. The second group (Group 2) consisted of 46 patients age over 7 to 12, with the average age of 9.7 ± 1.6, out of whom 30 (65.2%) were boys, and 16 (34.8%) were girls. There was no statistically relevant difference according to sex (p = 0.086). After the 3-month treatment, all the patients in both groups were tested for the effects of dDAVP in PMNE treatment.
RESULTS


The average enuresis frequency in the first group (Group 1) before therapy was 26.0 ± 6.2 per month, whereas the average enuresis frequency after therapy was 11.0 ± 8.0 per month (p = 0.040). The average enuresis frequency in the second group (Group 2) before therapy was 23.1 ± 6.2 per month, whereas the average enuresis frequency after therapy was 3.8 ± 3.6 per month (p = 0.036). ANOVA data analysis of repeated measurements has indicated that there is a statistically relevant interaction between the groups (p = 0.006), i.e. enuresis frequency decreases considerably more in the second group (Group 2).
CONCLUSION


PMNE with dDAVP is noticeably more effective with patients over 7 years of age.",2020,There was no statistically relevant difference according to sex (p = 0.086).,"['2014-2018 period, during which 89 patients were observed who were treated with dDAVP due to the previously diagnosed PMNE', ""primary monosymptomatic noctural enuresis treatment depending on Patients'Age"", '43 patients age 5 to 6, with the average age of 5.6\xa0±\xa00.5, out of whom 35 (81.4%) were boys, and 8 (18.6%) girls', '46 patients age over 7 to 12, with the average age of 9.7\xa0±\xa01.6, out of whom 30 (65.2%) were boys, and 16 (34.8%) were girls', ""primary monosymptomatic nocturnal enuresis (PMNE) treatment depending on patients'age""]","['dDAVP', 'desmopressin', 'Desmopressin (dDAVP']","['enuresis frequency', 'average enuresis frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0701195', 'cui_str': 'Desmospray'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C0701195', 'cui_str': 'Desmospray'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",43.0,0.0112588,There was no statistically relevant difference according to sex (p = 0.086).,"[{'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Radojicic', 'Affiliation': ""University Children's Hospital Belgrade. Electronic address: drzoranradojicic@gmail.com.""}, {'ForeName': 'Sasa', 'Initials': 'S', 'LastName': 'Milivojevic', 'Affiliation': ""University Children's Hospital Belgrade.""}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Milin Lazovic', 'Affiliation': 'Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Djordje', 'Initials': 'D', 'LastName': 'Toplicic', 'Affiliation': ""University Children's Hospital Belgrade.""}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Milic', 'Affiliation': 'Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Department of Internal Medicine, Mayo Clinic, Rochester, USA.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.08.003']
2010,32828687,Massage and heat application on labor pain and comfort: A quasi-randomized controlled experimental study.,"AIM


The aim of this study was to determine the effects of sacral massage and heat application on the perceptions of labor pain and comfort level in pregnant women.
METHODS


This was a quasi-randomized controlled experimental study. The data were collected under three groups in 2016: the heat application group (HAG), the massage group (MG), and the control group (CG). Each group included 30 primiparous pregnant women (range of age: 17-35) whose cervix was dilated to 4-5 cm. At 4-5 cm, 6-7 cm, and 8-9 cm cervical dilation, sacral massage was applied to MG, and sacral heat application was applied to HAG. Each group received standard midwifery care during labor. The data were collected using the Childbirth Comfort Questionnaire (CCQ) and the Numerical Rating Scale (NRS). The data were analyzed by using the Chi-square test, the Friedman test, Paired sample t-test, ANOVA, the Kruskal-Wallis test, and Wilcoxon signed-ranks test RESULTS: The mean pain score in HAG (4.56±0.67) during 4-5 cm of cervical dilation was significantly lower than those in MG (5.03±1.06) or CG (5.23±0.72) (p < 0.05). The mean pain scores in HAG (6.80±0.7) and MG (7.30±0.8) during 6-7 cm of cervical dilation were significantly lower than that in CG (7.70±0.5) (p < 0.001). Moreover, a statistically significant difference was found between the mean CCQ total scores (HAG: 31.06±3.46, CG: 27.66±3.85, p < 0.05), mean CCQ physical comfort scores (HAG: 13.16±1.89, CG: 11.03±1.80, p < 0.001), mean CCQ relief comfort level score (HAG: 11.23±1.43, CG: 10.00±2.01, p < 0.05) and mean CCQ transcendence comfort level scores (HAG: 19.83±2.37, CG: 17.66±2.15, p < 0.05) and both HAG and CG during 8-9 cm of cervical dilation.
CONCLUSIONS


Heat application and massage can be used as a safe and effective midwifery intervention to reduce the perception of pain in pregnant women and provide comfort during labor.",2020,"17.66±2.15, p < 0.05) and both HAG and CG during 8-9 cm of cervical dilation.
","['pregnant women', '30 primiparous pregnant women (range of age: 17-35) whose cervix was dilated to 4-5\xa0cm']","['sacral massage and heat application', 'Massage and heat application', 'heat application group (HAG), the massage group (MG', 'CG']","['mean pain scores', 'HAG and CG', 'labor pain and comfort level', 'labor pain and comfort', 'mean CCQ physical comfort scores', 'Childbirth Comfort Questionnaire (CCQ) and the Numerical Rating Scale (NRS', 'mean CCQ transcendence comfort level scores', 'mean CCQ total scores', 'perception of pain', 'mean CCQ relief comfort level score (HAG', 'cervical dilation', 'mean pain score in HAG']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}]","[{'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}]",30.0,0.0230464,"17.66±2.15, p < 0.05) and both HAG and CG during 8-9 cm of cervical dilation.
","[{'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Türkmen', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Balıkesir University, Balıkesir, Turkey. Electronic address: hulyaturkmen@balikesir.edu.tr.'}, {'ForeName': 'Nazan Tuna', 'Initials': 'NT', 'LastName': 'Oran', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Ege University, İzmir, Turkey. Electronic address: nazanoran@ege.edu.tr.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.08.002']
2011,32828721,Trial-by-Trial Fluctuations in Brain Responses to Stress Predict Subsequent Smoking Decisions That Occur Several Seconds Later.,"BACKGROUND


To investigate the neurobiological mechanisms that determine self-regulation of smoking urges when a person encounters stress, we investigated brain network interactions of smoking self-regulation by employing a real-time smoking (nicotine delivery) decision paradigm and a brain-as-predictor neuroimaging approach.
METHODS


While in the functional magnetic resonance imaging scanner, 25 cigarette smokers who abstained from smoking overnight made 200 real smoking decisions regarding whether or not to take a puff of an electronic cigarette during 3 different stress conditions (cognitive stress, emotional stress, and no stress). Cognitive stress was induced by a concurrent working memory load, and emotional stress was induced by manipulating a chance of aversive electric shock.
RESULTS


Behaviorally, both cognitive and emotional stress manipulations increased the probability of making a decision to smoke (i.e., taking a puff). In magnetic resonance imaging trial-by-trial analyses, the dorsolateral prefrontal cortex activity measured at the time of the stress cue significantly predicted future smoking decisions that occurred several seconds later. Furthermore, the influence of dorsolateral prefrontal cortex activity on smoking decisions was mediated by the ventral striatum activity at the time of smoking decisions.
CONCLUSIONS


Our study demonstrated that brain responses at the time of a stressful moment determine subsequent trial-by-trial smoking decisions by systematically altering brain executive (dorsolateral prefrontal cortex) and reward (ventral striatum) system network activities. Our results further suggest potential translational importance of neuroscientific approaches to predicting self-regulation failures at critical stressful moments.",2020,"Behaviorally, both cognitive and emotional stress manipulations increased the probability of making a decision to smoke (i.e., taking a puff).","['25 cigarette smokers who abstained from smoking overnight made 200 real smoking decisions regarding whether or not to take a puff of an electronic cigarette during 3 different stress conditions (cognitive stress, emotional stress, and no stress']",[],"['brain executive (dorsolateral prefrontal cortex) and reward (ventral striatum) system network activities', 'Brain Responses to Stress Predict Subsequent Smoking Decisions', 'dorsolateral prefrontal cortex activity', 'Cognitive stress', 'probability of making a decision to smoke']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0086209', 'cui_str': 'Emotional stress'}]",[],"[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",200.0,0.018067,"Behaviorally, both cognitive and emotional stress manipulations increased the probability of making a decision to smoke (i.e., taking a puff).","[{'ForeName': 'Seung-Lark', 'Initials': 'SL', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: limse@umkc.edu.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, Kansas; Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kansas City, Kansas; Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Kansas City, Kansas City, Missouri.""}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.06.012']
2012,32828737,Randomized Trial Comparing Consumption of Military Rations to Usual Intake for 21 Consecutive Days: Nutrient Adequacy and Indicators of Health Status.,"BACKGROUND


The US military Meal, Ready-to-Eat food ration is approved as a nutritionally adequate sole source of nutrition for ≤21 days. However, the ration continuously evolves, requiring periodic reassessment of its influence on nutritional status and health.
OBJECTIVE


To determine the effects of consuming the US Armed Services Meal, Ready-to-Eat ration for 21 days, relative to usual diets, on nutrient intake, and indicators of nutritional status and cardiometabolic health.
DESIGN


Parallel-arm, randomized, controlled trial, secondary analysis.
PARTICIPANTS


Sixty healthy, weight stable, free-living adults from the Natick, MA, area participated between June 2015 and March 2017.
INTERVENTION


Participants were randomized to consume their usual diet for 31days (CON), or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE).
MAIN OUTCOME MEASURES


Nutrient intake (absolute and adjusted) throughout the study period, and indicators of nutrition status (vitamins B, D, folate, homocysteine, iron, magnesium, and zinc) and cardiometabolic health (glucose, insulin, and blood lipid levels) before (Day 0), during (Day 10 through Day 21), and after (Day 31) the intervention period.
STATISTICAL ANALYSIS PERFORMED


Between-group differences over time were assessed using marginal models. Models for nutritional status and cardiometabolic health indicators were adjusted for age, initial body mass index, and baseline value of the dependent variable.
RESULTS


Energy-adjusted fiber; polyunsaturated fatty acids; vitamins A, thiamin, riboflavin, B-6, C, D, and E; and magnesium and zinc intakes all increased in MRE during the intervention and were higher compared with CON (P<0.05), whereas relative protein intake decreased and was lower (P<0.05). Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05). No statistically significant effects of diet on any other nutritional status or cardiometabolic health indicators were observed.
CONCLUSIONS


Findings demonstrate that a Meal, Ready-to-Eat ration diet can provide a more micronutrient-dense diet than usual dietary intake aiding in maintenance of nutritional status over 21 days.",2020,Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05).,"['Sixty healthy, weight stable, free-living adults from the Natick, MA, area participated between June 2015 and March\xa02017']","['consume their usual diet for 31days (CON), or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE', 'Consumption of Military Rations']","['nutritional status or cardiometabolic health indicators', 'Serum triglyceride concentrations', 'relative protein intake', 'MRE relative to CON', 'thiamin, riboflavin, B-6, C, D, and E; and magnesium and zinc intakes', 'nutrition status (vitamins B, D, folate, homocysteine, iron, magnesium, and zinc) and cardiometabolic health (glucose, insulin, and blood lipid levels']","[{'cui': 'C0424657', 'cui_str': 'Weight steady'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",60.0,0.0422149,Serum triglyceride concentrations averaged 19% (95% CI 0% to 41%) higher in MRE relative to CON during Days 10 to 31 (P=0.05).,"[{'ForeName': 'Holly L', 'Initials': 'HL', 'LastName': 'McClung', 'Affiliation': ''}, {'ForeName': 'Nicholes J', 'Initials': 'NJ', 'LastName': 'Armstrong', 'Affiliation': ''}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Hennigar', 'Affiliation': ''}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Staab', 'Affiliation': ''}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Montain', 'Affiliation': ''}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2020.06.018']
2013,32828785,Oral Calcium Supplements Associate With Serial Coronary Calcification: Insights From Intravascular Ultrasound.,"OBJECTIVES


This study sought to evaluate and assess the extent of serial coronary artery calcification in response to oral calcium supplementation.
BACKGROUND


Oral calcium supplements are frequently used despite their cardiovascular safety remaining controversial. Their effects on serial coronary calcification are not well established.
METHODS


In a post hoc patient-level analysis of 9 prospective randomized trials using serial coronary intravascular ultrasound, changes in serial percentage of atheroma volume (PAV) and calcium indices (CaI) were compared in matched segments of patients coronary artery disease who were receiving concomitant calcium supplements (n = 447) and in those who did not receive supplements (n = 4,700) during an 18- to 24-month trial period.
RESULTS


Patients (mean age 58 ± 9 years; 73% were men; 43% received concomitant high-intensity statins) demonstrated overall annualized changes in PAV and CaI with a mean of -0.02 ± 1.9% (p = 0.44) and a median of 0.02 (interquartile range: 0.00 to 0.06) (p < 0.001) from baseline, respectively. Following propensity-weighted mixed modeling adjusting for treatment and a range of demographic, clinical, ultrasonic, and laboratory parameters (including but not limited to sex, race, baseline, and annualized change in PAV, baseline CaI, concomitant high-intensity statins, diabetes mellitus, renal function), there were no significant between-group differences in annualized changes in PAV (least-squares mean: 0.09; 95% confidence interval [CI]: -0.20 to 0.37 vs. 0.01; 95% CI: -0.27 to 0.29; p = 0.092) according to calcium supplement intake. Per a multivariable logistic regression model accounting for the range of covariates described, calcium supplementation independently associated with an increase in annualized CaI (odds ratio: 1.15; 95% CI: 1.05 to 1.26; p = 0.004).
CONCLUSIONS


Oral calcium supplementation may increase calcium deposition in the coronary vasculature independent of changes in atheroma volume. The impact of these changes on plaque stability and cardiovascular outcomes requires further investigation.",2020,"Per a multivariable logistic regression model accounting for the range of covariates described, calcium supplementation independently associated with an increase in annualized CaI (odds ratio: 1.15; 95% CI: 1.05 to 1.26; p = 0.004).
","['With Serial Coronary Calcification', 'n\xa0=\xa0447) and in those who did not receive supplements (n\xa0=\xa04,700) during an 18- to 24-month trial period', 'patients coronary artery disease who were receiving']","['Oral calcium supplementation', 'concomitant calcium supplements', 'serial coronary intravascular ultrasound', 'Oral Calcium Supplements Associate']","['calcium deposition', 'serial coronary calcification', 'annualized CaI', 'serial percentage of atheroma volume (PAV) and calcium indices (CaI']","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0264956', 'cui_str': 'Atheroma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.170435,"Per a multivariable logistic regression model accounting for the range of covariates described, calcium supplementation independently associated with an increase in annualized CaI (odds ratio: 1.15; 95% CI: 1.05 to 1.26; p = 0.004).
","[{'ForeName': 'Najdat', 'Initials': 'N', 'LastName': 'Bazarbashi', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio; Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Department of Cardiology, MonashHeart, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Carlo', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Ohio.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Gad', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Antonette', 'Initials': 'A', 'LastName': 'Karrthik', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Sammour', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Diab', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Keerat Rai', 'Initials': 'KR', 'LastName': 'Ahuja', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'E Murat', 'Initials': 'EM', 'LastName': 'Tuzcu', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Ohio.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Ohio. Electronic address: purir@ccf.org.'}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2020.06.030']
2014,32828825,Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial.,"BACKGROUND


In EMBRACA, talazoparib prolonged progression-free survival versus chemotherapy (hazard ratio [HR] 0.542 [95% CI 0.413-0.711]; P < 0.0001) and improved patient-reported outcomes (PRO) in germline BRCA1/2 (gBRCA1/2)-mutated advanced breast cancer (ABC). We report final overall survival (OS).
PATIENTS AND METHODS


This randomized phase III trial enrolled patients with gBRCA1/2-mutated HER2-negative ABC. Patients received talazoparib or physician's choice of chemotherapy. OS was analyzed using stratified HR and log-rank test and prespecified rank-preserving structural failure time model to account for subsequent treatments.
RESULTS


431 patients were randomized (287 talazoparib/144 chemotherapy) with 412 patients treated (286 talazoparib/126 chemotherapy). By September 30, 2019, 216 deaths (75.3%) occurred for talazoparib and 108 (75.0%) chemotherapy; median follow-up was 44.9 and 36.8 months, respectively. HR for OS with talazoparib versus chemotherapy was 0.848 (95% CI 0.670-1.073; P = 0.17); median (95% CI) 19.3 months (16.6-22.5) versus 19.5 months (17.4-22.4). Kaplan-Meier survival percentages (95% CI) for talazoparib versus chemotherapy: Month 12, 71% (66-76)/74% (66-81); Month 24, 42% (36-47)/38% (30-47); Month 36, 27% (22-33)/21% (14-29). Most patients received subsequent treatments: for talazoparib and chemotherapy, respectively, 46.3%/41.7% received platinum and 4.5%/32.6% received a poly(ADP-ribose) polymerase (PARP) inhibitor. Adjusting for subsequent PARP and/or platinum use, HR for OS was 0.756 (95% bootstrap CI 0.503-1.029). Grade 3-4 adverse events occurred in 69.6% (talazoparib) and 64.3% (chemotherapy) patients, consistent with previous reports. Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P < 0.01 for all), consistent with initial analyses.
CONCLUSIONS


In gBRCA1/2-mutated HER2-negative ABC, talazoparib did not significantly improve OS over chemotherapy; subsequent treatments may have impacted analysis. Safety was consistent with previous observations. PRO continued to favor talazoparib.",2020,"Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P < 0.01 for all), consistent with initial analyses.
","['This randomized phase III trial enrolled patients with gBRCA1/2-mutated HER2-negative ABC', 'patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer', '431 patients were randomized (287 talazoparib/144 chemotherapy) with 412 patients treated (286 talazoparib/126 chemotherapy']","['poly(ADP-ribose) polymerase (PARP) inhibitor', 'talazoparib versus chemotherapy', 'Talazoparib versus chemotherapy', ""talazoparib or physician's choice of chemotherapy"", 'talazoparib and chemotherapy']","['Kaplan-Meier survival percentages', 'overall survival (OS', 'Grade 3-4 adverse events', 'global health status/quality of life and breast symptoms']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",431.0,0.135085,"Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P < 0.01 for all), consistent with initial analyses.
","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: jlitton@mdanderson.org.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Mina', 'Affiliation': 'Banner M.D. Anderson Cancer Center, Gilbert, AZ, USA.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'K-H', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Diab', 'Affiliation': 'Rocky Mountain Cancer Centers, Littleton, CO, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Woodward', 'Affiliation': 'Mater Misericordiae Ltd/Mater Research Institute and the University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goodwin', 'Affiliation': 'Medical Oncology Department, Concord Repatriation General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yerushalmi', 'Affiliation': 'Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roché', 'Affiliation': 'Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse, Toulouse, France.'}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Interdisziplinäres Onkologisches Zentrum München, Munich, Germany.'}, {'ForeName': 'R G W', 'Initials': 'RGW', 'LastName': 'Quek', 'Affiliation': 'Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Usari', 'Affiliation': 'Pfizer Oncology, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lanzalone', 'Affiliation': 'Pfizer Oncology, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Czibere', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Blum', 'Affiliation': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas, TX, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, CIBERONC, Departamento de Medicina, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.08.2098']
2015,32828873,Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Non-Variceal Upper Gastrointestinal Bleeding.,"BACKGROUND AND AIMS


No prior randomized controlled trial (RCT) has reported patient outcomes of large over-the-scope clip (OTSC) compared to standard hemostasis as initial endoscopic treatment of severe NVUGIB. This was our study aim.
METHODS


Patients with bleeding ulcers or Dieulafoy's lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe) were randomized to OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC). Patients and their healthcare providers were blinded to treatments and made all post-randomization management decisions. Ulcer patients received high dose intravenous infusions of proton pump inhibitors (PPI) for 3 days, then 27 days of oral PPI. 30 day outcomes were prospectively recorded; data management was with SAS; and data analysis was by a statistician.
RESULTS


53 patients (25 OTSC, 28 Standard) were randomized, with similar baseline risk factors. However, there were significant differences in OTSC vs. Standard groups in rates of rebleeding (4% vs. 28.6%; p = 0.017; relative risk 0.10, 95% confidence intervals 0.01, 0.91; number needed to treat 4); severe complications (0 % vs. 14.3%); and post-randomization units of red cell transfusions (0.04 vs. 0.68). All rebleeds occurred in patients with major SRH and none with lesser SRH.
CONCLUSION


1. OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions. 2. Patients with major stigmata benefited significantly from hemostasis with OTSC, but those with lesser stigmata did not.",2020,"OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions.","['53 patients (25 OTSC, 28 Standard', ""Patients with bleeding ulcers or Dieulafoy's lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe"", 'Severe Non-Variceal Upper Gastrointestinal Bleeding', 'Ulcer patients']","['OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC', 'Scope Clip', 'OTSC', 'proton pump inhibitors (PPI']","['number needed to treat 4); severe complications', 'rates of rebleeding', 'rates of rebleeding, severe complications, and post-randomization red cell transfusions', 'hemostasis with OTSC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer'}, {'cui': 'C0341217', 'cui_str': ""Dieulafoy's vascular malformation""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0441086', 'cui_str': 'Doppler probe'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085148', 'cui_str': 'Endoscopic Hemostasis'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]",2.0,0.223487,"OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions.","[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Jensen', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, CA; David Geffen School of Medicine at UCLA and Ronald Reagan UCLA Medical Center, Los Angeles; West Los Angeles Veterans Administration Medical Center, Los Angeles, CA. Electronic address: djensen@mednet.ucla.edu.'}, {'ForeName': 'Kovacs', 'Initials': 'K', 'LastName': 'Tog', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, CA; David Geffen School of Medicine at UCLA and Ronald Reagan UCLA Medical Center, Los Angeles.'}, {'ForeName': 'Ghassemi', 'Initials': 'G', 'LastName': 'Ka', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, CA; David Geffen School of Medicine at UCLA and Ronald Reagan UCLA Medical Center, Los Angeles.'}, {'ForeName': 'Kaneshiro', 'Initials': 'K', 'LastName': 'M', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, CA; David Geffen School of Medicine at UCLA and Ronald Reagan UCLA Medical Center, Los Angeles.'}, {'ForeName': 'Gornbein', 'Initials': 'G', 'LastName': 'J', 'Affiliation': 'David Geffen School of Medicine at UCLA and Ronald Reagan UCLA Medical Center, Los Angeles; Department of Medicine - GIM - DOMSTATS, UCLA, Los Angeles, CA, United States.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.046']
2016,32828877,Influence of artificial tears on keratometric measurements in cataract patients.,"PURPOSE


Assessing the influence of artificial tears of different viscosity on K-readings prior to cataract surgery.
DESIGN


Prospective randomized cross-over, before-and-after clinical study METHODS: Setting: Department of Ophthalmology, Medical University Vienna PATIENT POPULATION: A total of 123 eyes of 80 patients prior to cataract surgery were assigned to two groups based on normal and dry eyes.
INTERVENTION


Two native baseline keratometries were followed by instillation of either high- or low-viscosity eye-drops. Keratometry was repeated 30 seconds, 2 minutes and 5 minutes after instillation.
MAIN OUTCOME MEASURES


Influence of eye-drops of different viscosity in normal and dry eyes on short time K-readings.
RESULTS


Repeatability between native baseline measurements was high (SD=0.02mm in normal and in dry eyes). In normal and dry eyes, a statistically significant increase in measurement variability after instillation of both low-viscosity and high-viscosity eye-drops was observed (p<0.01). Measurement variability was most pronounced between baseline measurement and 30 seconds and diminished over time. Variability of K-readings appeared higher in dry eyes compared to normal eyes. Astigmatism changed more than 0.5 diopters in 13.2% of normal eyes and 34.4% in dry eyes using eye drops of high viscosity.
CONCLUSION


Tear film stabilizing eye-drops prior to keratometry measurements influenced K-readings significantly, especially in dry eyes. A time period of more than five minutes should be allowed to pass after instillation of eye-drops. The higher the viscosity of the eye-drops, the stronger the influence and the longer its persistence.",2020,"A total of 123 eyes of 80 patients prior to cataract surgery were assigned to two groups based on normal and dry eyes.
","['cataract patients', 'A total of 123 eyes of 80 patients prior to cataract surgery', 'Setting: Department of Ophthalmology, Medical University Vienna PATIENT POPULATION']","['artificial tears', 'high- or low-viscosity eye-drops']","['Variability of K-readings', 'Measurement variability', 'K-readings', 'keratometric measurements', 'measurement variability']","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",123.0,0.0380802,"A total of 123 eyes of 80 patients prior to cataract surgery were assigned to two groups based on normal and dry eyes.
","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Röggla', 'Affiliation': 'Medical University of Vienna, Department of Ophthalmology and Optometry, Spitalgasse 23, 1090 Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Medical University of Vienna, Department of Ophthalmology and Optometry, Spitalgasse 23, 1090 Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Medical University of Vienna, Department of Ophthalmology and Optometry, Spitalgasse 23, 1090 Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Medical University of Vienna, Department of Ophthalmology and Optometry, Spitalgasse 23, 1090 Vienna, Austria.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Meyer', 'Affiliation': 'Section for Medical Statistics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria.'}, {'ForeName': 'Claudette', 'Initials': 'C', 'LastName': 'Abela-Formanek', 'Affiliation': 'Medical University of Vienna, Department of Ophthalmology and Optometry, Spitalgasse 23, 1090 Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Medical University of Vienna, Department of Ophthalmology and Optometry, Spitalgasse 23, 1090 Vienna, Austria. Electronic address: rupert.menapace@meduniwien.ac.at.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.024']
2017,32828880,"SCORE2 Report 13: Intraretinal Hemorrhage Changes in Eyes with Central or Hemiretinal Vein Occlusion Managed with Aflibercept, Bevacizumab or Observation. Secondary Analysis of the SCORE and SCORE2 Clinical Trials.","PURPOSE


To investigate the relationship between intraretinal macular hemorrhage and visual acuity outcomes in eyes with CRVO or HRVO managed with aflibercept, bevacizumab, or observation.
DESIGN


Retrospective analysis of data from two randomized clinical trials.
METHODS


362 participants were randomized in the Study of COmparative Treatments for REtinal Vein Occlusion 2 and 88 participants randomized to observation in the Standard Care versus COrticosteroid in REtinal Vein Occlusion Study. Participants received monthly intravitreal aflibercept or bevacizumab through Month 6 or observation through Month 8. Main outcome was visual acuity letter score (VALS).
RESULTS


Reduced area of hemorrhage by Month 6 was observed in 70.7% (116/164) of aflibercept-treated eyes, 63.8% (104/163) of bevacizumab-treated eyes, and 42.2% (27/64) of observation eyes by Month 8 (P<0.01). Relative to eyes with hemorrhage during follow-up: aflibercept-treated eyes without hemorrhage at Month 6 had a mean VALS improvement of 8.0 (99% CI: 1.9, 14.2); bevacizumab-treated eyes without hemorrhage at Month 6 had a mean VALS improvement of 3.2 (99% CI: -4.6, 11.0); observation eyes without hemorrhage at Month 8 had a mean VALS improvement of 13.5 (99% CI: 0.4, 26.5). At Month 6, presence of hemorrhage and change in central subfield thickness (CST) were significantly associated with change in VALS; however, CST was a more important predictor.
CONCLUSION


Improvement in hemorrhage during follow-up was associated with visual acuity improvements and predicted visual acuity changes beyond what was explained by CST. These findings suggest intraretinal macular hemorrhage is an important indicator of disease severity in retinal vein occlusion.",2020,"RESULTS


Reduced area of hemorrhage by Month 6 was observed in 70.7% (116/164) of aflibercept-treated eyes, 63.8% (104/163) of bevacizumab-treated eyes, and 42.2% (27/64) of observation eyes by Month 8 (P<0.01).","['362 participants', 'eyes with CRVO or HRVO managed with', 'Eyes with Central or Hemiretinal Vein Occlusion']","['Standard Care versus COrticosteroid', 'Aflibercept, Bevacizumab or Observation', 'bevacizumab', 'CST', 'REtinal Vein Occlusion', 'intravitreal aflibercept or bevacizumab', 'aflibercept, bevacizumab, or observation']","['visual acuity letter score (VALS', 'visual acuity improvements and predicted visual acuity changes', 'intraretinal macular hemorrhage and visual acuity outcomes', 'presence of hemorrhage and change in central subfield thickness (CST', 'area of hemorrhage', 'mean VALS improvement']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1735356', 'cui_str': 'Hemiretinal vein occlusion'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0035328', 'cui_str': 'Retinal vein occlusion'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",362.0,0.313113,"RESULTS


Reduced area of hemorrhage by Month 6 was observed in 70.7% (116/164) of aflibercept-treated eyes, 63.8% (104/163) of bevacizumab-treated eyes, and 42.2% (27/64) of observation eyes by Month 8 (P<0.01).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hendrick', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'VanVeldhuisen', 'Affiliation': 'The Emmes Company, LLC, Rockville, MD. Electronic address: score2@emmes.com.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'The Emmes Company, LLC, Rockville, MD.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Blodi', 'Affiliation': 'University of Wisconsin Fundus Photograph Reading Center, Madison, WI.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, University of California, Los Angeles, California.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, CA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Oden', 'Affiliation': 'The Emmes Company, LLC, Rockville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.030']
2018,32828927,"Virtual training leads to physical, cognitive and neural benefits in healthy adults.","Physical activity, such as high-intensity intermittent aerobic exercise (HIE), can improve executive functions. Although performing strength or aerobic training might be problematic or not feasible for someone. An experimental situation where there is no actual movement, but the body shows physiological reactions, is during the illusion through immersive virtual reality (IVR). We aimed to demonstrate whether a virtual HIE-based intervention (vHIE) performed exclusively by the own virtual body has physical, cognitive, and neural benefits on the real body. 45 healthy young adults (cross-over design) experienced HIE training in IVR (i.e., the virtual body performed eight sets of 30 s of running followed by 30 s of slow walking, while the subject is completely still) in two random-ordered conditions (administered in two sessions one week apart): the virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP). During the vHIE, we recorded the heart rate and subjective questionnaires to confirm the effectiveness of the illusion; before and after vHIE, we measured cortical hemodynamic changes in the participants' left dorsolateral prefrontal cortex (lDLPFC) using the fNIRS device during the Stroop task to test our main hypothesis. Preliminary, we confirmed that the illusion was effective: during the vHIE in 1PP, subjects' heart rate increased coherently with the virtual movements, and they reported subjective feelings of ownership and agency. Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently. Clinically, these results might be exploited to train cognition and body simultaneously. Theoretically, we proved that the sense of body ownership and agency can affect other parameters, even in the absence of actual movements.",2020,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","['healthy adults', '45 healthy young adults']","['strength or aerobic training', 'virtual HIE-based intervention (vHIE', 'Virtual training', 'Physical activity, such as high-intensity intermittent aerobic exercise (HIE', 'virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP', 'HIE training']","['heart rate and subjective questionnaires', 'lDLPFC activity', 'heart rate']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",45.0,0.0142803,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","[{'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Burin', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan. Electronic address: burin.dalila.c3@tohoku.ac.jp.'}, {'ForeName': 'Yingxu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Noriki', 'Initials': 'N', 'LastName': 'Yamaya', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117297']
2019,32828931,Stable symptom clusters and evolving symptom networks in relation to chemotherapy cycles.,"CONTEXT


The existence of stable symptom clusters with variations or changes in cluster membership and the merging of symptom clusters over time urges us to investigate how symptom relationships change over time.
OBJECTIVES


To identify stable symptom clusters and understand networks among symptoms using longitudinal data.
METHODS


Secondary data analysis was conducted using data from a nonblinded randomized clinical trial, which evaluated the effect and feasibility of the developed cancer symptom management system. For the current study, data from all participants of the original trial were analyzed (N=249). The severity of 20 symptoms was measured before the start of chemotherapy (CTx) and during the initial 4 cycles of CTx. Symptom clusters were identified using principal component and hierarchical cluster analyses, and network analysis was used to explore the relationships among symptoms.
RESULTS


Three common symptom clusters were identified. The first cluster consisted of anxiety, depression, sleep disturbance, pain and dyspnea. Fatigue, difficulty concentrating, and drowsiness formed a second stable cluster throughout the CTx cycles. The third cluster comprised loss of appetite, taste change, nausea and vomiting. In terms of the symptom networks, close relationships were recognized, irrespective of symptom severity level, between anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change. Fatigue was the most central symptom with the highest strength. Edge thickening after starting CTx demonstrated evolving symptom networks in relation to CTx cycles.
CONCLUSION


Stable symptom clusters and evolving networks were identified. The most central symptom was fatigue; however, the paucity of studies which investigated symptom networks and central symptoms calls for further investigations on these phenomena. Identification of central symptoms and underlying mechanisms will guide efficient symptom management. Future studies will need to focus on developing comprehensive interventions for managing symptom clusters or targeting central symptoms.",2020,"In terms of the symptom networks, close relationships were recognized, irrespective of symptom severity level, between anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change.",[],[],"['severity of 20 symptoms', 'anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change', 'loss of appetite, taste change, nausea and vomiting', 'Fatigue, difficulty concentrating, and drowsiness', 'Fatigue', 'anxiety, depression, sleep disturbance, pain and dyspnea']",[],[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.0475643,"In terms of the symptom networks, close relationships were recognized, irrespective of symptom severity level, between anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change.","[{'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Rha', 'Affiliation': 'Professor, College of Medicine & Yonsei Cancer Center, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Associate Professor College of Nursing & Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, Korea, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Korea. Electronic address: jiyeonest@yuhs.ac.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.08.008']
2020,32828934,Five-strand versus four-strand hamstring autografts in anterior cruciate ligament reconstruction - A prospective randomized controlled study.,"PURPOSE


The purpose of this 2-year follow-up study is to compare the clinical outcomes of the routine use of 5-strand hamstring grafts (where possible) with those of 4-strand grafts in primary anterior cruciate ligament (ACL) reconstruction. The hypothesis was that the routine use of 5-strand grafts would lead to superior clinical outcomes.
METHODS


A total of 64 patients were enrolled in a prospective randomized controlled study comparing the use of 5-strand and 4-strand semitendinosus-gracilis autografts in single bundle ACL reconstruction (n=32 in each group). 4 participants in each group were lost to follow-up, and were excluded from the outcomes analysis. The outcomes of 28 patients in the 5-strand group and 28 patients in the 4-strand group were analyzed. The diameters of all grafts were measured intra-operatively. Patients were assessed post-operatively at 2-years with objective assessments (anterior knee laxity using the KT-2000 arthrometer, Lachman test, Pivot-shift test, Hop test) and patient reported outcome scores (Lysholm knee score, KOOS, IKDC subjective knee score, SF-36 physical and mental components, Tegner activity scale). Post-operative graft ruptures were also noted.
RESULTS


There were improvements in all outcome measures post-operatively regardless of the number of graft strands. Comparing the study and control groups, there were no significant differences in all subjective and objective outcome measures except the KOOS symptoms score (5-strand group 93.3 ± 9.2 vs 4-strand group 86.2 ± 14.7, p=0.04). The KT-2000 side to side difference was 2.79 ± 2.11mm in the 5-strand group, and 2.54 ± 1.75mm in the 4-strand group (p=0.63). The 5-strand study group had two graft ruptures at 1 year, while the 4-strand control group had one partial graft rupture at 6 months.
CONCLUSIONS


At the 2-year follow-up, the routine use of the 5-strand hamstring tendon autograft was not superior to that of the quadrupled or 4-strand graft in primary ACL reconstruction.",2020,"Comparing the study and control groups, there were no significant differences in all subjective and objective outcome measures except the KOOS symptoms score (5-strand group 93.3 ± 9.2 vs 4-strand group 86.2 ± 14.7, p=0.04).","['28 patients in the 5-strand group and 28 patients in the 4-strand group were analyzed', 'anterior cruciate ligament reconstruction ', 'primary anterior cruciate ligament (ACL) reconstruction', '64 patients']","['Five-strand versus four-strand hamstring autografts', '5-strand hamstring grafts', '5-strand and 4-strand semitendinosus-gracilis autografts in single bundle ACL reconstruction']","['KOOS symptoms score', 'graft ruptures', 'objective assessments (anterior knee laxity using the KT-2000 arthrometer, Lachman test, Pivot-shift test, Hop test) and patient reported outcome scores (Lysholm knee score, KOOS, IKDC subjective knee score, SF-36 physical and mental components, Tegner activity scale', 'partial graft rupture', 'number of graft strands']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0224439', 'cui_str': 'Structure of gracilis muscle'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0183894', 'cui_str': 'Arthrometer'}, {'cui': 'C0231752', 'cui_str': 'Lachman test response'}, {'cui': 'C3669378', 'cui_str': 'Pivot shift test'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scoring Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Level'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",64.0,0.0346747,"Comparing the study and control groups, there were no significant differences in all subjective and objective outcome measures except the KOOS symptoms score (5-strand group 93.3 ± 9.2 vs 4-strand group 86.2 ± 14.7, p=0.04).","[{'ForeName': 'Lingaraj', 'Initials': 'L', 'LastName': 'Krishna', 'Affiliation': 'Division of Sports Medicine and Surgery, Department of Orthopaedic Surgery, National University Hospital, National University Health System (NUHS), Singapore.'}, {'ForeName': 'Chloe Xiaoyun', 'Initials': 'CX', 'LastName': 'Chan', 'Affiliation': 'Division of Sports Medicine and Surgery, Department of Orthopaedic Surgery, National University Hospital, National University Health System (NUHS), Singapore. Electronic address: chloe.chan@mohh.com.sg.'}, {'ForeName': 'Lakshmipathi', 'Initials': 'L', 'LastName': 'Lokaiah', 'Affiliation': 'Department of Rehabilitation, National University Hospital, National University Health System (NUHS), Singapore.'}, {'ForeName': 'Duraimurugan', 'Initials': 'D', 'LastName': 'Chinnasamy', 'Affiliation': 'Department of Rehabilitation, National University Hospital, National University Health System (NUHS), Singapore.'}, {'ForeName': 'Saumitra', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': 'Division of Sports Medicine and Surgery, Department of Orthopaedic Surgery, National University Hospital, National University Health System (NUHS), Singapore.'}, {'ForeName': 'Mingchang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Division of Sports Medicine and Surgery, Department of Orthopaedic Surgery, National University Hospital, National University Health System (NUHS), Singapore.'}, {'ForeName': 'Amritpal', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopaedic Surgery, Ng Teng Fong General Hospital.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.08.012']
2021,32828993,Comparison of different surgical procedures on the stability of Dental Implants in Posterior Maxilla: a randomized clinical study.,"BACKGROUND


Stability of a dental implant is very important when planning immediate loading and design of a final restoration. The aim of this study was to compare the primary and the secondary stability of dental implants inserted by three different surgical techniques: conventional (standard) technique using a sequence of drills for implant bed preparation, osteotome technique using tapered hand instruments for creating implant sites by condensing the bone and guided flapless implant surgery with surgical templates.
MATERIAL AND METHODS


The study included 150 patients (80 males and 70 females), 46-71 years old, who required implant supported fixed partial dentures in the posterior maxilla of D3 or D4 bone density. Patients were randomly assigned into one of the three surgical insertion technique groups. All patients received tapered implants of the same manufacturer of the same length and two different widths (3.3 x 11.5 mm or 4.2 x 11.5 mm). Primary and secondary implant stability were measured by means of resonance frequency analysis (RFA) at the time of implant placement and 5 months after surgery using the Ostell ISQ device (Osstell AB, Sampgatan, Goteborg, Sweden). Statistical analysis included one-sample Kolmogorov Smirnov test, descriptive statistics, multivariate analysis (Bonferoni post-hoc tests) and paired t-tests.
RESULTS


Patients in the osteotome group exhibited higher primary stability (P < 0.01) than in the conventional and surgically guided flapless groups. There were no significant differences in the secondary stability (p >  0.05). Wider implants presented higher ISQ values (P<0.01).
CONCLUSION


The osteotome technique led to the highest implant primary stability, therefore it can be recommended when immediate loading is planned or for one-piece implant insertion.",2020,"RESULTS


Patients in the osteotome group exhibited higher primary stability (P < 0.01) than in the conventional and surgically guided flapless groups.","['Posterior Maxilla', '150 patients (80 males and 70 females), 46-71 years old, who required implant supported fixed partial dentures in the posterior maxilla of D3 or D4 bone density']",['surgical techniques: conventional (standard) technique'],"['ISQ values', 'Ostell ISQ device (Osstell AB, Sampgatan, Goteborg, Sweden', 'stability of Dental Implants', 'secondary stability', 'primary stability']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",150.0,0.114953,"RESULTS


Patients in the osteotome group exhibited higher primary stability (P < 0.01) than in the conventional and surgically guided flapless groups.","[{'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Planinić', 'Affiliation': 'Private dental office, Medjugorje, Bosnia and Hercegovina.'}, {'ForeName': 'Dubravica', 'Initials': 'D', 'LastName': 'Ivica', 'Affiliation': 'Private dental office, Vodice, Croatia.'}, {'ForeName': 'Šarac', 'Initials': 'Š', 'LastName': 'Zdenko', 'Affiliation': 'Department of head and neck diseases, School of Medicine, University of Mostar, Mostar, Bosnia and Hercegovina.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Poljak-Guberina', 'Affiliation': 'Department of Dental Prosthetics, School of Medicine, University of Split, Split, Croatia. Electronic address: poljak@sfzg.hr.'}, {'ForeName': 'Celebic', 'Initials': 'C', 'LastName': 'Asja', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Bago', 'Initials': 'B', 'LastName': 'Ivona', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Cabov', 'Initials': 'C', 'LastName': 'Tomislav', 'Affiliation': 'Department of Oral Surgery, School of Dental Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Peric', 'Initials': 'P', 'LastName': 'Berislav', 'Affiliation': 'Department of Oral Surgery, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.08.004']
2022,31816049,History and Correlates of Smoking Cessation Behaviors Among Smokers With Serious Mental Illness.,"INTRODUCTION


Individuals with serious mental illness (SMI) smoke at rates two to three times greater than the general population but are less likely to receive treatment. Increasing our understanding of correlates of smoking cessation behaviors in this group can guide intervention development.
AIMS AND METHODS


Baseline data from an ongoing trial involving smokers with SMI (N = 482) were used to describe smoking cessation behaviors (ie, quit attempts, quit motivation, and smoking cessation treatment) and correlates of these behaviors (ie, demographics, attitudinal and systems-related variables).
RESULTS


Forty-three percent of the sample did not report making a quit attempt in the last year, but 44% reported making one to six quit attempts; 43% and 20%, respectively, reported wanting to quit within the next 6 months or the next 30 days. Sixty-one percent used a smoking cessation medication during their quit attempt, while 13% utilized counseling. More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking. Greater quit motivation was associated with lower carbon monoxide, minority race, benefits of cessation counseling, and importance of counseling within the clinic. A greater likelihood of using smoking cessation medications was associated with being female, smoking more cigarettes, and receiving smoking cessation advice. A greater likelihood of using smoking cessation counseling was associated with being male, greater academic achievement, and receiving smoking cessation advice.
CONCLUSIONS


Many smokers with SMI are engaged in efforts to quit smoking. Measures of smoking cessation behavior are associated with tobacco use indicators, beliefs about smoking, race and gender, and receiving cessation advice.
IMPLICATIONS


Consideration of factors related to cessation behaviors among smokers with SMI continues to be warranted, due to their high smoking rates compared to the general population. Increasing our understanding of these predictive characteristics can help promote higher engagement in evidence-based smoking cessation treatments among this subpopulation.",2020,More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking.,"['Smokers', 'Baseline data from an ongoing trial involving smokers with SMI (N = 482', 'smokers with SMI']",[],"['smoking cessation behaviors', 'Smoking Cessation Behaviors', 'Greater quit motivation', 'smoking cessation medication']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",482.0,0.0126191,More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking.,"[{'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Wileyto', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Ziedonis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine, Pulmonary, Allergy, & Critical Care Division, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mandell', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kimberly', 'Affiliation': 'Department of Management, The Wharton School of Business, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Rinad', 'Initials': 'R', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz229']
2023,31820002,Motivational Interviewing to Encourage Quit Attempts Among Smokers Not Ready to Quit: A Trial-Based Economic Analysis.,"INTRODUCTION


This study used data from a randomized controlled trial evaluating the efficacy of motivational interviewing (MI) relative to health education (HE) and brief advice (BA) to encourage quit attempts and cessation in order to determine their relative cost-effectiveness.
AIMS AND METHODS


Urban community residents (n = 255) with low desire to quit smoking were randomized to MI, HE, or BA which differed in communication style and/or number of treatment sessions. Incremental cost-effectiveness ratios were used to compare the intensive interventions (MI and HE) to BA for facilitating quit attempts and smoking cessation. Costs were calculated from the perspective of an agency that might engage in program delivery. Sensitivity analysis examined different assumptions for MI training and pharmacotherapy costs.
RESULTS


Total intervention delivery time costs per participant for MI, HE, and BA were $46.63, $42.87, and $2.4, respectively. Cost-effectiveness ratios per quit attempt at 24 weeks were $380 for MI, $272 for HE, and $209 for BA. The cost per additional quit attempt for MI and HE relative to BA was $508 and $301, respectively. The cost per additional quit for MI and HE relative to BA was $2030 and $752, respectively. Four separate sensitivity analyses conducted in our study did not change the conclusion the HE had a lower Incremental Cost-Effectiveness Ratio for both quit attempts and cessation.
CONCLUSIONS


HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit. Providing valuable cost information in choosing different clinical methods for motivating smokers to quit.
IMPLICATIONS


All direct costs and activity-based time costs associated with delivering the intervention were analyzed from the perspective of an agency that may wish to replicate these strategies. A randomized controlled trial evaluating the efficacy of MI relative to HE and BA to encourage quit attempts and cessation determined their relative cost-effectiveness. HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable. Despite guideline recommendations, MI may not be the best approach to encourage quit attempts in diverse populations. Rather, a structured, intensive HE intervention might be the most cost-effective alternative.",2020,HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit.,"['Quit', 'Smokers', 'Urban community residents (n = 255) with low desire to quit smoking']","['Motivational Interviewing', 'MI relative to HE and BA', 'motivational interviewing (MI) relative to health education (HE) and brief advice (BA']","['Incremental cost-effectiveness ratios', 'cost per additional quit for MI and HE relative to BA', 'Total intervention delivery time costs per participant for MI, HE, and BA', 'Incremental Cost-Effectiveness Ratio', 'cost per additional quit attempt for MI and HE relative to BA', 'Cost-effectiveness ratios per quit attempt']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}]",255.0,0.0521855,HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit.,"[{'ForeName': 'Rafia S', 'Initials': 'RS', 'LastName': 'Rasu', 'Affiliation': 'University of North Texas Health Science Center, Fort Worth, TX.'}, {'ForeName': 'Joanie', 'Initials': 'J', 'LastName': 'Thelen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, MO.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Agbor Bawa', 'Affiliation': 'University of North Texas Health Science Center, Fort Worth, TX.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Division of Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO.""}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz228']
2024,31828315,A Randomized Clinical Trial Examining the Effects of Instructions for Electronic Cigarette Use on Smoking-Related Behaviors and Biomarkers of Exposure.,"INTRODUCTION


Electronic cigarettes (e-cigarettes) have the potential to significantly reduce exposure to harmful constituents associated with cigarette smoking when smokers completely substitute cigarettes with e-cigarettes. This study examined patterns of e-cigarette and cigarette use, and extent of toxicant exposure, if smokers were instructed and incentivized to completely switch to e-cigarettes compared to instructions to use the product ad libitum.
AIMS AND METHODS


US adult daily smokers (n = 264; 49.2% female; Mage = 47.0), uninterested in quitting smoking immediately, were recruited from Minneapolis, MN, Columbus, OH, and Buffalo, NY. Participants were randomized to 8 weeks of instructions for (1) ad libitum use of e-cigarettes (AD-E), (2) complete substitution of cigarettes with e-cigarettes (CS-E), (3) complete substitution of cigarettes with nicotine gum or lozenge (CS-NRT), or (4) continue smoking of usual brand cigarettes (UB). Participants were incentivized for protocol compliance, including complete switching in the CS-E and CS-NRT groups. Outcome variables were cigarette smoking rate and tobacco-related biomarkers of exposure.
RESULTS


Smokers in the CS-E and CS-NRT groups showed lower rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens, and other toxicants than smokers in the AD-E group. In general, no significant differences were observed between CS-E versus CS-NRT or between AD-E versus UB for most biomarkers. Significantly higher 7-day point prevalence smoke-free rates were observed for CS-E versus CS-NRT.
CONCLUSIONS


Smokers instructed and incentivized to completely switch to e-cigarettes resulted in lower smoking rates and greater reductions in exposures to harmful chemicals than smokers instructed to use the product ad libitum.
IMPLICATIONS


Smokers instructed to completely substitute e-cigarettes for cigarettes displayed significantly lower levels of smoking and biomarkers of exposure to carcinogens and toxicants, compared to smokers instructed to use e-cigarettes ad libitum and similar levels as smokers instructed to completely substitute with nicotine replacement therapies. Furthermore, a higher rate of complete switching was achieved with e-cigarettes versus nicotine replacement therapies. Approaches to maximize complete substitution with e-cigarettes are an important area for future research.",2020,"RESULTS


Smokers in the CS-E and CS-NRT groups showed lower rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens, and other toxicants than smokers in the AD-E group.","['US adult daily smokers (n = 264; 49.2% female; Mage = 47.0), uninterested in quitting smoking immediately, were recruited from Minneapolis, MN, Columbus, OH, and Buffalo, NY']","['nicotine replacement therapies', 'instructions for (1) ad libitum use of e-cigarettes (AD-E), (2) complete substitution of cigarettes with e-cigarettes (CS-E), (3) complete substitution of cigarettes with nicotine gum or lozenge (CS-NRT), or (4) continue smoking of usual brand cigarettes (UB']","['higher rate of complete switching', 'rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens', 'smoking rates', '7-day point prevalence smoke-free rates', 'Smoking-Related Behaviors and Biomarkers of Exposure', 'cigarette smoking rate and tobacco-related biomarkers of exposure']","[{'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0007090', 'cui_str': 'Carcinogen'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]",,0.0151011,"RESULTS


Smokers in the CS-E and CS-NRT groups showed lower rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens, and other toxicants than smokers in the AD-E group.","[{'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Wisconsin - Stevens Point, Stevens Point, WI.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Reisinger', 'Affiliation': 'James Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Kaila J', 'Initials': 'KJ', 'LastName': 'Norton', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Strayer', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dick', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Mei-Kuen', 'Initials': 'MK', 'LastName': 'Tang', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Menglan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'connor"", 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Shields', 'Affiliation': 'James Cancer Center, The Ohio State University, Columbus, OH.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz233']
2025,31964219,Protective role of black seed oil in doxorubicin-induced cardiac toxicity in children with acute lymphoblastic leukemia.,"BACKGROUND


Leukemia is the most common pediatric malignancy. It affects bone marrow cells especially lymphoid cell precursor. Leukemia is treated mainly by chemotherapy. Doxorubicin is a well-established chemotherapeutic agent included in treatment protocols of acute lymphoblastic leukemia. Its efficacy is often limited by its cardiotoxic side effects. Many studies are directed to overcome this problem. Black seed oil was found to have a potent cardioprotective effect. Aim of the study:  To assess the protective role of black seed oil against doxorubicin-induced cardiotoxicity in children with acute lymphoblastic leukemia.
SUBJECTS AND METHODS


This study was carried out on 40 children with acute lymphoblastic leukemia including 20 patients under doxorubicin therapy and black seed oil 80 mg/kg/dose divided into 3 doses starting at the same moment of beginning of doxorubicin infusion therapy and continued for 1 week after each doxorubicin dose [group I] and 20 patients under doxorubicin and placebo for 1 week after each doxorubicin dose [group II]. They underwent conventional echo-Doppler measures of left ventricular systolic and diastolic functions and pulsed wave tissue Doppler of lateral mitral annulus.
RESULTS


No significant differences were found in parameters of electrocardiograph including S-T segment and Q-T interval either before or after doxorubicin therapy. No significant differences in echocardiographic parameters were found between group I and group II before therapy. Non-significant changes in parameters of diastolic function [E/A ratio or e/a ratio] were found after doxorubicin therapy in group I and II, but there were significant reduction in parameters of systolic function [EF, FS and s wave] after doxorubicin therapy more in group II than group I. Conclusion and recommendation:  From this study, we concluded that: Black seed oil improves some cardiac side effects of doxorubicin as shown by better systolic functions in children with acute lymphoblastic leukemia who were treated with Doxorubicin and black seed (group I) than in children with acute lymphoblastic leukemia who were treated with doxorubicin alone with no black seeds (group II), and therefore multi center studies is recommended to be done before we can recommend the use of black seed oil as an adjuvant therapy in patients with acute lymphoblastic leukemia under doxorubicin-based treatment protocol.",2020,"Non-significant changes in parameters of diastolic function [E/A ratio or e/a ratio] were found after doxorubicin therapy in group I and II, but there were significant reduction in parameters of systolic function [EF, FS and s wave] after doxorubicin therapy more in group II than group I. Conclusion and recommendation:  From this study","['40 children with acute lymphoblastic leukemia including 20 patients under', 'patients with acute lymphoblastic leukemia under', 'group I) than in children with acute lymphoblastic leukemia', '20 patients under', 'children with acute lymphoblastic leukemia', 'acute lymphoblastic leukemia', 'children with acute lymphoblastic leukemia who were treated with']","['black seed oil in doxorubicin', 'doxorubicin dose [group', 'doxorubicin and placebo', 'Black seed oil', 'doxorubicin alone with no black seeds', 'doxorubicin-based treatment protocol', 'Doxorubicin and black seed', 'doxorubicin', 'conventional echo-Doppler measures of left ventricular systolic and diastolic functions and pulsed wave tissue Doppler of lateral mitral annulus', 'doxorubicin infusion therapy', 'black seed oil against doxorubicin-induced cardiotoxicity', 'doxorubicin therapy and black seed oil 80', 'Doxorubicin']","['echocardiographic parameters', 'systolic function [EF, FS and s wave', 'parameters of electrocardiograph including S-T segment and Q-T interval', 'systolic functions', 'cardiac toxicity', 'diastolic function [E/A ratio or e/a ratio']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0225947', 'cui_str': 'Structure of anulus fibrosus of mitral orifice'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0429094', 'cui_str': 'S wave feature'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0122988,"Non-significant changes in parameters of diastolic function [E/A ratio or e/a ratio] were found after doxorubicin therapy in group I and II, but there were significant reduction in parameters of systolic function [EF, FS and s wave] after doxorubicin therapy more in group II than group I. Conclusion and recommendation:  From this study","[{'ForeName': 'Adel A', 'Initials': 'AA', 'LastName': 'Hagag', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Badraia', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Walid A', 'Initials': 'WA', 'LastName': 'El-Shehaby', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Maaly M', 'Initials': 'MM', 'LastName': 'Mabrouk', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219897294']
2026,32829027,"Aflibercept With or Without Suprachoroidal CLS-TA for Diabetic Macular Edema: A Randomized, Double-Masked, Parallel-Design, Controlled Study.","PURPOSE


This study evaluated the potential safety, efficacy, and durability advantages of CLS-TA administered suprachoroidally in conjunction with intravitreal aflibercept compared to aflibercept monotherapy for the treatment of Diabetic Macular Edema (DME).
DESIGN


TYBEE was a prospective, randomized, controlled, double-masked study. Subjects were randomized 1:1 to CLS-TA in conjunction with aflibercept ('Active') or aflibercept monotherapy ('Control') and tracked over 24 weeks.
PARTICIPANTS


Treatment-naïve DME subjects with Best Corrected Visual Acuity (BCVA) 20-70 letters and central subfield retinal thickness (CST) > 300 μm.
METHODS


Subjects in the Active group (n=36) received CLS-TA in conjunction with aflibercept at baseline and week 12. Subjects in the Control group (n=35) received aflibercept at baseline, week 4, week 8, and week 12. All subjects were eligible to receive aflibercept as needed (PRN) at weeks 4, 8, 16 and 20 per additional therapy criteria: presence of macular edema CST ≥ 340 μm; increase in CST of > 50 μm associated with a decrease in BCVA (≥6 letters from the previous visit or 10 letters from the best measurement) MAIN OUTCOME MEASURE: Mean change in BCVA from baseline; treatment differences were assessed with a 2-sided significance level of 0.10.
RESULTS


Mean changes from baseline in BCVA at week 24 were not statistically different in the Active and Control groups (+11.4 and +13.8 letters, p=0.288, intention to treat (ITT); +12.3 and +13.5 letters, p=0.664, per protocol (PP) populations, respectively). Greater improvement in CST was seen in the Active group versus Control (-212.1 μm and -178.6 μm, p=0.089, ITT; -226.5 μm and -176.1 μm, p=0.035, PP, respectively). Eyes in the Active group received an average of 2.6 treatments, while eyes in the Control group received an average of 4.6 treatments. No treatment-related serious AEs were observed. Elevated IOP and cataract events trended higher in the Active group versus the Control group.
CONCLUSION


CLS-TA administered suprachoroidally in conjunction with IVT aflibercept in the treatment of DME provides no visual benefit at 24 weeks follow up compared to IVT aflibercept monotherapy, but a modest anatomical benefit and the potential to reduce treatment burden. Ocular adverse events were low for both arms.",2020,"Mean changes from baseline in BCVA at week 24 were not statistically different in the Active and Control groups (+11.4 and +13.8 letters, p=0.288, intention to treat (ITT); +12.3 and +13.5 letters, p=0.664, per protocol (PP) populations, respectively).","['Diabetic Macular Edema', 'Treatment-naïve DME subjects with Best Corrected Visual Acuity (BCVA) 20-70 letters and central subfield retinal thickness (CST) > 300 μm', 'Subjects in the Active group (n=36) received', 'Diabetic Macular Edema (DME']","['Aflibercept With or Without Suprachoroidal CLS-TA', ""CLS-TA in conjunction with aflibercept ('Active') or aflibercept monotherapy ('Control"", 'aflibercept', 'aflibercept monotherapy', 'CLS-TA in conjunction with aflibercept', 'intravitreal aflibercept', 'CLS-TA']","['BCVA', 'Ocular adverse events', 'CST', 'Elevated IOP and cataract events', 'Mean change in BCVA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0006790', 'cui_str': 'Calusterone'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.115216,"Mean changes from baseline in BCVA at week 24 were not statistically different in the Active and Control groups (+11.4 and +13.8 letters, p=0.288, intention to treat (ITT); +12.3 and +13.5 letters, p=0.664, per protocol (PP) populations, respectively).","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Barakat', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ. Electronic address: mark.barakat@gmail.com.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, TX; Blanton Eye Institute, Houston Methodist Hospital, Houston, TX.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Gonzalez', 'Affiliation': 'Valley Retina Institute, PA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Cumberland Valley Retina Consultants, Hagerstown, MD.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Marcus', 'Affiliation': 'Southeast Retina Center, PC, Augusta, GA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zavaleta', 'Affiliation': 'West Texas Retina Consultants, LLC, Abilene, TX; Retina Research Institute of Texas, Abilene, TX.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Ciulla', 'Affiliation': 'Clearside Biomedical, Inc.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.08.007']
2027,32829060,The role of endogenous Antisecretory Factor (AF) in the treatment of Ménière's Disease: A two-year follow-up study. Preliminary results.,"PURPOSE


To evaluate the effects of increased endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC) in a sample of patients with defined unilateral Meniere's disease (MD), compared to the results of a treatment protocol of intravenous glycerol and dexamethasone.
MATERIALS AND METHODS


Twenty-six patients with unilateral MD were divided in 2 groups and treated with SPC and with intravenous glycerol and dexamethasone for 24 months. Audio-vestibular evaluation was performed before (T0) and every six months. The number of vertigo spells were evaluated before and after therapy and the Efficacy Index (EI) was calculated. Questionnaires for hearing loss, tinnitus and quality of life were administered.
RESULTS


EI decreased in the SPC group after 18 (T18) (p = .0017) and 24 (T24) months of therapy (p = .0111). There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131). No significant differences were found between the two groups at T0 (p = .4723), while a significant difference was found at T24 (p = .0027). Quality of life showed a significant improvement in daily activities in the SPC group (p = .0033) compared to the infusion therapy group. No statistically significant changes in PTA thresholds were found in both groups between T0 and T24.
CONCLUSION


The preliminary results of our study show a significant reduction of vertigo spells and a positive effect on tinnitus severity and on quality of life in patients with unilateral MD treated with SPC and when compared to patients treated with intravenous glycerol and dexamethasone. No effects on hearing thresholds were noted in both groups.",2020,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"['Twenty-six patients with unilateral MD', ""Ménière's Disease"", 'patients with unilateral MD treated with', ""patients with defined unilateral Meniere's disease (MD""]","['SPC and with intravenous glycerol and dexamethasone', 'endogenous Antisecretory Factor (AF', 'glycerol and dexamethasone', 'intravenous glycerol and dexamethasone', 'SPC', 'endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC']","['Efficacy Index (EI', 'number of vertigo spells', 'daily activities', 'tinnitus severity and on quality of life', 'hearing thresholds', 'hearing loss, tinnitus and quality of life', 'Quality of life', 'vertigo spells', 'PTA thresholds', 'tinnitus score']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0025281', 'cui_str': ""Ménière's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0052093', 'cui_str': 'antisecretory factor'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0201493,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Viola', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Pisani', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Scarpa', 'Affiliation': 'Department of Medicine and Surgery, University of Salerno, Salerno, Italy. Electronic address: alfonsoscarpa@yahoo.it.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cassandro', 'Affiliation': 'Surgical Sciences Department, University of Turin, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Laria', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit of Audiology, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Aragona', 'Affiliation': 'Otolaryngology, A.O.U. Ospedali Riuniti, Ancona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ciriolo', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Spadera', 'Affiliation': 'Otolaryngology, San Leonardo Hospital, Castellammare di Stabia, Napoli, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavaliere', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Iengo', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Chiarella', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102673']
2028,32829105,Determination of the UGT1A1 polymorphism as guidance for irinotecan dose escalation in metastatic colorectal cancer treated with first-line bevacizumab and FOLFIRI (PURE FIST).,"AIM


Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism plays a crucial role in the increased susceptibility of patients to irinotecan and its toxicity. This study is a multicenter, randomised clinical trial comparing the clinical outcomes and adverse events (AEs) in metastatic colorectal cancer (mCRC) patients treated with bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan dose escalation as the first-line therapy.
METHODS


The control group received conventional biweekly FOLFIRI plus bevacizumab without UGT1A1 genotyping, whereas the study group received the same regimen with irinotecan dose escalation based on UGT1A1 genotyping. The primary end-point was progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate.
RESULTS


Over a median follow-up of 26.0 months (IQR, 17.0-35.0 months), study group (n = 107) was superior to the control group (n = 106) in PFS, OS, ORR, DCR, and metastasectomy rate (all P < 0.05). Furthermore, there were no significant differences in AEs ≥ grade III between the two groups, even with the 1.36-fold increase in the relative dose intensity of irinotecan in the study group. Dose escalation of irinotecan, an independent factor of ORR (P < 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
CONCLUSION


The current study revealed that mCRC patients, regardless of KRAS gene status, with UGT1A1 genotyping can tolerate escalated doses of irinotecan and potentially achieve a more favourable clinical outcome without significantly increased toxicities.
CLINICAL TRIAL REGISTRATION


NCT02256800.",2020,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","['metastatic colorectal cancer (mCRC) patients treated with', 'metastatic colorectal cancer treated with first-line']","['bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan', 'bevacizumab and FOLFIRI (PURE FIST', 'conventional biweekly FOLFIRI plus bevacizumab', 'irinotecan dose escalation based on UGT1A1 genotyping', 'irinotecan']","['DCR', 'progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate', 'PFS', 'PFS, OS, ORR, DCR, and metastasectomy rate', 'toxicities']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041986', 'cui_str': 'Uridine diphosphate'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0336667', 'cui_str': 'Fist'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0452964,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","[{'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: chunpin870132@yahoo.com.tw.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: baseball5824@yahoo.com.tw.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lin', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: linyiewen@yahoo.com.tw.'}, {'ForeName': 'Jui-Ho', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. Electronic address: rayhowang@gmail.com.'}, {'ForeName': 'Chang-Chieh', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Keelung Branch, Tri-Service General Hospital, Keelung, Taiwan. Electronic address: doc20276@gmail.com.'}, {'ForeName': 'Yung-Chuan', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Taipei Cathay General Hospital, Taipei, Taiwan. Electronic address: yungchuans@cgh.org.tw.'}, {'ForeName': 'Tzu-Liang', 'Initials': 'TL', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: golfma22@gmail.com.'}, {'ForeName': 'Hwei-Ming', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: phillipwhm@gmail.com.'}, {'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Tang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Sin-Lan Hospital, Tainan, Taiwan. Electronic address: schoetz.tang@gmail.com.'}, {'ForeName': 'Joe-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan. Electronic address: jbchen@vghtc.gov.tw.'}, {'ForeName': 'Tao-Wei', 'Initials': 'TW', 'LastName': 'Ke', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: ketaowei@gmail.com.'}, {'ForeName': 'Chang-Sung', 'Initials': 'CS', 'LastName': 'Tsai', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: chonsonechai@gmail.com.'}, {'ForeName': 'Hsuan-Yuan', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan. Electronic address: 107431@cch.org.tw.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: cy614112@ms14.hinet.net.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.031']
2029,32829109,High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production in obese men in response to an acute exercise bout.,"The aim of this study was to evaluate the inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin) profile of inactive obese men in response to two isoenergetic models of aerobic exercise training (~300  kcal each exercise session). Twenty-two participants (28.7 ± 1.6 years; BMI = 34.4 ± 0.1 kg/m 2 ) were randomized into two groups: I) HIIT: high-intensity interval training (10× 1 bout: 1 min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT). Both groups trained three times per week for 6-weeks. Fasting blood samples were collected before and 0, 30, and 60 min after exercise during the first and last training sessions for evaluation of: I) MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10 were analyzed before, 0, and 60 min after sessions. IL-6 concentration remained elevated up to 60-min after the acute exercise session (p < 0.001), and IL-10 concentration was higher after 30 and 60-min (p = 0.001) compared to rest, independent of training period and protocol. AUC of IL-10 presented effect of type of training (p = 0.023) with MICT group showed significantly higher values than the HIIT. The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period. Fifteen subjects presented decreased HOMA-IR after 6-weeks and seven presented an increase in this index. When we excluded the two least responsive subjects, it was possible to observe a decrease in HOMA-IR (p = 0.020) after training. Taken together, our results suggest that both HIIT and MICT (with same energy expenditure) promote similar effects on HOMA-IR and led to elevations in IL-10 production in LPS-stimulated whole blood, suggesting that leukocytes had an enhanced ability to secrete anti-inflammatory cytokines after the exercise bout.",2020,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","['Twenty-two participants (28.7\xa0±\xa01.6\xa0years; BMI\xa0=\xa034.4\xa0±\xa00.1\xa0kg/m 2 ', 'obese men in response to an acute exercise bout', 'inactive obese men']","['MICT', 'HIIT and MICT', 'IL-6', 'inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin', 'HIIT: high-intensity interval training (10× 1 bout: 1\xa0min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT', 'aerobic exercise training', 'High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production']","['MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10', 'HOMA-IR', 'Fasting blood samples', 'IL-10 secretion', 'concentration', 'IL-10 concentration']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0237388,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil; Physical Education, Physiotherapy, University Center of Maringa (UniCesumar), Parana, Brazil.'}, {'ForeName': 'Paula Alves', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Daniela Sayuri', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Batatinha', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Gilson Pires', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'José Cesar', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil. Electronic address: fabio.lira@unesp.br.'}]",Cytokine,['10.1016/j.cyto.2020.155249']
2030,32829304,Longitudinal panretinal microaneurysm dynamics on ultra-widefield fluorescein angiography in eyes treated with intravitreal aflibercept for proliferative diabetic retinopathy in the recovery study.,"BACKGROUND/AIMS


Quantifying microaneurysms (MAs) turnover may be an objective measure for therapeutic response in diabetic retinopathy. This study assesses changes in MA counts on ultra-widefield fluorescein angiography (UWFA) in subjects undergoing treatment with intravitreal aflibercept injection (IAI) for proliferative diabetic retinopathy (PDR) in the Intravit re al Afliber c ept for Retinal N o n-Perfusion in Proliferati v e Diab e tic  R etinopath y (RECOVERY) study using an automated MA detection platform.
METHODS


RECOVERY is a prospective study that enrolled 40 subjects with PDR randomised 1:1 to receive 2 mg IAI every 4 weeks(q4wk) or every 12 weeks (q12wk). UWFA images were obtained at baseline, 6 months and 1 year. Images were analysed using an automated segmentation platform to detect and quantify MAs. Zones 1, 2 and 3 correspond to the macula, mid-periphery and far-periphery, respectively.
RESULTS


The q4wk cohort demonstrated a significant decline in MAs in all zones and panretinally at baseline versus month 6, baseline versus year 1, and month 6 versus year 1 (-20.0% to -61.8%; all p<0.001). In the q12wk cohort, baseline versus month 6 showed a significant decline panretinally (mean: -34.2%; p<0.001) and in zone 3 (mean -44.18%; p<0.001). Addiitonally, baseline to year 1 in the q12wk group demonstrated significant decline panretinally (mean: -47.7%; p<0.001) and in zone 3 (mean: -59.8%; p<0.001). All zones demonstrated significantly decline from month 6 to year 1 in the q12wk group.
CONCLUSION


Therapy with IAI demonstrates significantly reduced panretinal MA counts in PDR at 1 year in both treatment groups. The use of automated platforms to detect and quantify MAs may provide a novel imaging marker for evaluating disease activity and therapeutic impact.
TRIAL REGISTRATION NUMBER


NCT02863354.",2020,"The q4wk cohort demonstrated a significant decline in MAs in all zones and panretinally at baseline versus month 6, baseline versus year 1, and month 6 versus year 1 (-20.0% to -61.8%; all p<0.001).","['diabetic retinopathy', 'enrolled 40 subjects with PDR', 'subjects undergoing treatment with']","['ultra-widefield fluorescein angiography (UWFA', 'ultra-widefield fluorescein angiography', 'intravitreal aflibercept', 'intravitreal aflibercept injection (IAI']","['MAs', 'panretinal MA counts']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0333101', 'cui_str': 'Microaneurysm'}, {'cui': 'C0442132', 'cui_str': 'Panretinal'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",40.0,0.0846932,"The q4wk cohort demonstrated a significant decline in MAs in all zones and panretinally at baseline versus month 6, baseline versus year 1, and month 6 versus year 1 (-20.0% to -61.8%; all p<0.001).","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Babiuch', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Charles Clifton', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Retina Consultants of Houston, Houston, Texas, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Hach', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Talcott', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Retina Consultants of Houston, Houston, Texas, USA.'}, {'ForeName': 'Muneeswar', 'Initials': 'M', 'LastName': 'Nittala', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California, USA.'}, {'ForeName': 'SriniVas', 'Initials': 'S', 'LastName': 'Sadda', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Le', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Reese', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio, USA ehlersj1@yahoo.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316952']
2031,32829400,BCG vaccination in infancy does not protect against COVID-19. Evidence from a natural experiment in Sweden.,"BACKGROUND


The Bacille Calmette-Guérin (BCG) tuberculosis vaccine has immunity benefits against respiratory infections. Accordingly, it has been hypothesized to have a protective effect against COVID-19. Recent research found that countries with universal BCG childhood vaccination policies tend to be less affected by the COVID-19 pandemic. However, such ecological studies are biased by numerous confounders. Instead, this paper takes advantage of a rare nationwide natural experiment that took place in Sweden in 1975, where discontinuation of newborns BCG vaccination led to a dramatic fall of the BCG coverage rate, thus allowing us to estimate the BCG's effect without the biases associated with cross-country comparisons.
METHODS


Numbers of COVID-19 cases and hospitalizations were recorded for birth cohorts born just before and just after 1975, representing 1,026,304 and 1,018,544 individuals, respectively. We used regression discontinuity to assess the effect of BCG vaccination on Covid-19 related outcomes. This method used on such a large population allows for a high precision that would be hard to achieve using a randomized controlled trial.
RESULTS


The odds ratio for Covid-19 cases and Covid-19 related hospitalizations were 1·0005 (CI95: [0·8130-1·1881]) and 1·2046 (CI95: [0·7532-1·6560]), allowing us to reject fairly modest effects of universal BCG vaccination. We can reject with 95% confidence that universal BCG vaccination reduces the number of cases by 19% and the number of hospitalizations by 25%.
CONCLUSIONS


While the effect of a recent vaccination must be evaluated, we provide strong evidence that receiving the BCG vaccine at birth does not have a protective effect against COVID-19 among middle-aged individuals.",2020,"We can reject with 95% confidence that universal BCG vaccination reduces the number of cases by 19% and the number of hospitalizations by 25%.
","['Evidence from a natural experiment in Sweden', 'Numbers of COVID-19 cases and hospitalizations were recorded for birth cohorts born just before and just after 1975, representing 1,026,304 and 1,018,544 individuals, respectively', 'middle-aged individuals']",['universal BCG vaccination'],[],"[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.165255,"We can reject with 95% confidence that universal BCG vaccination reduces the number of cases by 19% and the number of hospitalizations by 25%.
","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'de Chaisemartin', 'Affiliation': 'Department of Economics, University of California, Santa Barbara, Santa Barbara, CA 93106, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'de Chaisemartin', 'Affiliation': 'Immunology Department, APHP.Nord-Université de Paris, Bichat Hospital, Paris, France.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1223']
2032,32829410,Efavirenz Pharmacogenetics and Weight Gain following Switch to Integrase Inhibitor-containing Regimens.,"BACKGROUND


Unwanted weight gain affects some people living with HIV who are prescribed integrase strand transfer inhibitors (INSTI). Mechanisms and risk factors are incompletely understood.
METHODS


We utilized two cohorts to study pharmacogenetics of weight gain following switch from efavirenz- to INSTI-based regimens. In an observational cohort, we studied weight gain at 48 weeks following switch from efavirenz- to INSTI-based regimens among patients who had been virologically suppressed for at least 2 years at a clinic in the United States. Associations were characterized with CYP2B6 and UGT1A1 genotypes that affect efavirenz and INSTI metabolism, respectively. In a clinical trials cohort, we studied weight gain at 48 weeks among treatment-naïve participants who were randomized to receive efavirenz-containing regimens in AIDS Clinical Trials Group studies A5095, A5142 and A5202 and did not receive INSTIs.
RESULTS


In the observational cohort (N=61), CYP2B6 slow metabolizers had greater weight gain after switch (p=0.01). This was seen following switch to elvitegravir or raltegravir, but not dolutegravir. UGT1A1 genotype was not associated with weight gain. In the clinical trials cohort (N=462), CYP2B6 slow metabolizers had lesser weight gain at week 48 among participants receiving efavirenz with tenofovir disoproxil fumarate (p=0.001) but not those receiving efavirenz with abacavir (p=0.65). Findings were consistent when stratified by race/ethnicity and by sex.
CONCLUSIONS


Among patients who switched from efavirenz- to INSTI-based therapy, CYP2B6 genotype was associated with weight gain, possibly reflecting withdrawal of the inhibitory effect of higher efavirenz concentrations on weight gain. The difference by concomitant nucleoside analogue is unexplained.",2020,UGT1A1 genotype was not associated with weight gain.,"['at 48 weeks among treatment-naïve participants', 'patients who had been virologically suppressed for at least 2 years at a clinic in the United States', 'people living with HIV who are prescribed integrase strand transfer inhibitors (INSTI']","['efavirenz with tenofovir disoproxil fumarate', 'efavirenz-containing regimens in AIDS Clinical Trials Group studies A5095, A5142 and A5202 and did not receive INSTIs', 'Efavirenz', 'elvitegravir or raltegravir', 'efavirenz with abacavir']","['Weight Gain', 'weight gain']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0376601', 'cui_str': 'Integrase strand transfer inhibitor-containing product'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1320290', 'cui_str': 'Clinical trial group'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2606637', 'cui_str': 'elvitegravir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.164307,UGT1A1 genotype was not associated with weight gain.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Leonard', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Zinhle', 'Initials': 'Z', 'LastName': 'Cindi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Bradford', 'Affiliation': 'Department of Genetics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kassem', 'Initials': 'K', 'LastName': 'Bourgi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Koethe', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Jamison', 'Initials': 'J', 'LastName': 'Norwood', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Woodward', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Husamettin', 'Initials': 'H', 'LastName': 'Erdem', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Basham', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Rebeiro', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Sterling', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hulgan', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Daar', 'Affiliation': 'Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Gulick', 'Affiliation': 'Weill Cornell Medicine, New York, New York, NY, USA.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Riddler', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Phumla', 'Initials': 'P', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Marylyn D', 'Initials': 'MD', 'LastName': 'Ritchie', 'Affiliation': 'Department of Genetics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Haas', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1219']
2033,32829456,Pilot Study of a Virtual Reality Educational Intervention for Radiotherapy Patients Prior to Initiating Treatment.,"Virtual reality (VR) presents opportunities for innovative patient educational methods. This study used a combination of subjective questionnaires and objective physiological measures to investigate the impact of a VR radiotherapy (RT) educational system on patients' understanding and anxiety prior to commencing RT. Sixty patients were randomized to control (n = 30) and intervention (n = 30) groups prior to initiating RT. The control group received the standard nursing care process. The intervention group additionally participated in a detailed introduction to RT positioning, procedures, treatments, and other RT-related information via VR education. All patients completed a data collection from pre- and postintervention, which included questions on RT comprehension, anxiety-related scales, and objective physiological data reflecting the patient's psychological state, such as blood pressure, heart rate, and respiration. Both groups had high anxiety levels before the intervention, and there was no significant difference between the questionnaire and physiological data of the two groups. Following the intervention, anxiety scores (state-trait anxiety scale and visual analog scale) of the intervention group decreased significantly compared with those of the control group, and there was a significant decrease in systolic blood pressure (p < 0.05) and increase in cognitive score (p < 0.05). This study reports the positive impact of a virtual reality radiotherapy (VRRT) patient educational system on increasing patient RT comprehension and reducing anxiety. Further work is needed to improve the acceptability of the system to patients and to explore further the impact of VR education on patients' psychological and physical needs.",2020,"Following the intervention, anxiety scores (state-trait anxiety scale and visual analog scale) of the intervention group decreased significantly compared with those of the control group, and there was a significant decrease in systolic blood pressure (p < 0.05) and increase in cognitive score (p < 0.05).","[""patients' understanding and anxiety prior to commencing RT"", 'Sixty patients']","['Virtual Reality Educational Intervention', 'Virtual reality (VR', 'VR radiotherapy (RT) educational system', 'virtual reality radiotherapy (VRRT) patient educational system', 'standard nursing care process']","[""RT comprehension, anxiety-related scales, and objective physiological data reflecting the patient's psychological state, such as blood pressure, heart rate, and respiration"", 'cognitive score', 'systolic blood pressure', 'patient RT comprehension and reducing anxiety', 'anxiety scores (state-trait anxiety scale and visual analog scale', 'high anxiety levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",60.0,0.0199379,"Following the intervention, anxiety scores (state-trait anxiety scale and visual analog scale) of the intervention group decreased significantly compared with those of the control group, and there was a significant decrease in systolic blood pressure (p < 0.05) and increase in cognitive score (p < 0.05).","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qingmin', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Mengya', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. whuhcce@163.com.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01848-5']
2034,32829494,"""Music Makes My Old Heart Beat"": A Randomised Controlled Study on the Benefits of the Use of Music in Comprehensive Care for Institutionalised Older Adults.","BACKGROUND


Research on the therapeutic use of music is growing, but the lack of experimental rigour and outcomes diversity has impeded researchers from obtaining clear evidence of the multiple benefits of music interventions in older adults. We explored the outcomes of a music-complemented intervention integrated into the therapeutic activities of institutionalised elderly people.
METHODS


A randomised controlled study with baseline, post-intervention, and 2-week follow-up measures was carried out with 50 residents in a caring institution. Several indicators of physical health, cognitive functioning, emotional well-being, pain, and happiness were assessed at all phases.
RESULTS


Mixed factorial ANOVAs showed a positive impact of the music intervention on the outcomes in the intervention group (effect sizes up to .78) compared to the stability in the control (waiting list) group. Notably, the benefits seemed to be temporary, as they decreased progressively after the discontinuation of the intervention.
CONCLUSIONS


This study demonstrates the effects of a planned music-based intervention on several health- and well-being-related outcomes and has important applications regarding the use of music as a complement in therapeutic interventions with elderly people. The implementation of music therapy within the comprehensive care of institutionalised people must be maintained over time for the effects to be durable.",2020,"RESULTS


Mixed factorial ANOVAs showed a positive impact of the music intervention on the outcomes in the intervention group (effect sizes up to .78) compared to the stability in the control (waiting list) group.","['older adults', 'institutionalised elderly people', 'elderly people', 'Institutionalised Older Adults', '50 residents in a caring institution']","['Music', 'music-complemented intervention integrated', 'planned music-based intervention']","['physical health, cognitive functioning, emotional well-being, pain, and happiness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",,0.0678944,"RESULTS


Mixed factorial ANOVAs showed a positive impact of the music intervention on the outcomes in the intervention group (effect sizes up to .78) compared to the stability in the control (waiting list) group.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Castillejos', 'Affiliation': 'Universidad de Granada, Granada, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Godoy-Izquierdo', 'Affiliation': 'Universidad de Granada, Granada, Spain.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12217']
2035,32829497,"Comment on ""Investigation of topical intranasal cocaine for sinonasal procedures: a randomized, phase III clinical trial"".",,2020,,['sinonasal procedures'],['topical intranasal cocaine'],[],"[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",[],,0.0336323,,"[{'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Francis', 'Affiliation': 'Division of Medical Toxicology, Ronald O. Perelman Department of Emergency Medicine, NYU Langone Medical Center, 455 First Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Backus', 'Affiliation': 'Division of Medical Toxicology, Ronald O. Perelman Department of Emergency Medicine, NYU Langone Medical Center, 455 First Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Howland', 'Affiliation': 'New York City Poison Control Center, 455 First Avenue, New York, NY, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Hoffman', 'Affiliation': 'Division of Medical Toxicology, Ronald O. Perelman Department of Emergency Medicine, NYU Langone Medical Center, 455 First Avenue, New York, NY, 10016, USA.'}]",International forum of allergy & rhinology,['10.1002/alr.22676']
2036,32829526,"Intradialytic Isometric Handgrip Exercise Does Not Cause Hemodynamic Instability: A Randomized, Cross-Over, Pilot Study.","Hemodialysis patients experience hemodynamic instability. Intradialytic exercise seems to attenuate it. This study aimed to verify the acute hemodynamic response to different intradialytic handgrip exercise intensities in hemodialysis patients. In a randomized, cross-over, experimental pilot study, 8 patients completed two experimental sessions and one control in random order: i) regular hemodialysis, ii) low-intensity isometric handgrip exercise, and ii) moderate-intensity isometric handgrip exercise. Blood pressure and heart rate variability were recorded immediately before and every 15 minutes. Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (p>0.05). The systolic blood pressure and double product significantly increased immediately after the moderate-intensity protocol (122.0±15.9 vs 131.3±19.8, p<0.05; 9094.7±1705.7 vs 9783.0±1947.9, p<0.05, respectively) but returned to the pre-exercise values 10 minutes later. We conclude that intradialytic isometric handgrip exercise does not induce hemodynamic instability at low- and moderate-intensities.",2020,"Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (p>0.05).","['Hemodialysis patients experience hemodynamic instability', 'hemodialysis patients']","['Isometric handgrip exercise protocols', 'Intradialytic Isometric Handgrip Exercise', 'intradialytic handgrip exercise intensities', 'intradialytic isometric handgrip exercise', 'regular hemodialysis, ii) low-intensity isometric handgrip exercise, and ii) moderate-intensity isometric handgrip exercise', 'Intradialytic exercise']","['hemodynamic instability', 'hemodynamic stability', 'systolic blood pressure', 'Cause Hemodynamic Instability', 'Blood pressure and heart rate variability']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",8.0,0.0224199,"Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (p>0.05).","[{'ForeName': 'Heitor Siqueira', 'Initials': 'HS', 'LastName': 'Ribeiro', 'Affiliation': 'Faculty of Physical Education, University of Brasília (UnB), Federal District, Brazil.'}, {'ForeName': 'Vinícius Albuquerque', 'Initials': 'VA', 'LastName': 'Cunha', 'Affiliation': 'Faculty of Health Science, University of Brasília (UnB), Brazil.'}, {'ForeName': 'Victor Mota', 'Initials': 'VM', 'LastName': 'Baiao', 'Affiliation': 'University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'Lucas Silva', 'Initials': 'LS', 'LastName': 'Almeida', 'Affiliation': 'Faculty of Physical Education, University of Brasília (UnB), Federal District, Brazil.'}, {'ForeName': 'Gustavo Ítalo', 'Initials': 'GÍ', 'LastName': 'Dourado', 'Affiliation': 'Faculty of Health Science, University of Brasília (UnB), Brazil.'}, {'ForeName': 'Helton Lucas', 'Initials': 'HL', 'LastName': 'Carvalho', 'Affiliation': 'University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'Marvery Peterson', 'Initials': 'MP', 'LastName': 'Duarte', 'Affiliation': 'Faculty of Physical Education, University of Brasília (UnB), Federal District, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Inda-Filho', 'Affiliation': 'University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'João Luís', 'Initials': 'JL', 'LastName': 'Viana', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University Institute of Maia (ISMAI), Portugal.'}, {'ForeName': 'Otávio Toledo', 'Initials': 'OT', 'LastName': 'Nóbrega', 'Affiliation': 'Faculty of Health Science, University of Brasília (UnB), Brazil.'}, {'ForeName': 'Aparecido Pimentel', 'Initials': 'AP', 'LastName': 'Ferreira', 'Affiliation': 'University Center ICESP, Brasília, Brazil.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13581']
2037,32829540,Comparison Of Two Intra-Canal Medicaments On The Incidence Of Post-Operative Endodontic Pain.,"BACKGROUND


Post-operative pain is the most annoying factor for the patients for which different intra-canal medicaments are used. The aim of this study was to compare calcium hydroxide mixed with dexamethasone and triple antibiotic paste as intra-canal medicaments on the incidence of post-operative endodontic pain.
METHODS


This was a randomized controlled trail in which a total of 120 patients presenting to the department of Operative Dentistry AFID, Rawalpindi from 20-50 years of age from both gender presenting with acute apical periodontitis in their maxillary and mandibular central incisors were selected and randomly divided into three equal groups of 40 patients with the help of scientific random number table. Group A patients were given calcium hydroxide mixed with dexamethasone, group B patients were given triple antibiotic paste and in group C patients only cotton pellet was placed in the pulp chamber as a placebo. Endodontic therapy was initiated, following pulpectomy and disinfection, canals were prepared and intra-canal dressings were placed according to the allotted group and restored with cavit. Pain was recorded at 24, 48 and 72 hours using the visual analogue scale. Data was analysed using SPSS 21.
RESULTS


After 72 hours, 55% of group A patients had no pain, 47.5% patients in group B while in group C 17.5% of the patients reported no pain.
CONCLUSIONS


Both calcium hydroxide combined with dexamethasone and triple antibiotic paste are effective in reducing post-operative pain in teeth with symptomatic irreversible pulpitis while placebo showed little reduction in pain.",2020,"CONCLUSIONS


Both calcium hydroxide combined with dexamethasone and triple antibiotic paste are effective in reducing post-operative pain in teeth with symptomatic irreversible pulpitis while placebo showed little reduction in pain.","['40 patients with the help of scientific random number table', '120 patients presenting to the department of Operative Dentistry AFID, Rawalpindi from 20-50 years of age from both gender presenting with acute apical periodontitis in their maxillary and mandibular central incisors']","['Endodontic therapy', 'Two Intra-Canal Medicaments', 'calcium hydroxide combined with dexamethasone and triple antibiotic paste', 'calcium hydroxide mixed with dexamethasone and triple antibiotic paste', 'placebo', 'triple antibiotic paste and in group C patients only cotton pellet was placed in the pulp chamber as a placebo', 'calcium hydroxide mixed with dexamethasone']","['Pain', 'Incidence Of Post-Operative Endodontic Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011440', 'cui_str': 'Operative Dentistry'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0155934', 'cui_str': 'Acute apical periodontitis of pulpal origin'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0456386', 'cui_str': 'Medicament'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0441436', 'cui_str': 'Pellet gun missile'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0034099', 'cui_str': 'Pulp chamber of tooth'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}]",120.0,0.115891,"CONCLUSIONS


Both calcium hydroxide combined with dexamethasone and triple antibiotic paste are effective in reducing post-operative pain in teeth with symptomatic irreversible pulpitis while placebo showed little reduction in pain.","[{'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'Department of Operative Dentistry, Armed Forces Institute of Dentistry, Rawalpindi, Pakistan.'}, {'ForeName': 'Ajmal', 'Initials': 'A', 'LastName': 'Yousaf', 'Affiliation': 'Department of Operative Dentistry, Armed Forces Institute of Dentistry, Rawalpindi, Pakistan.'}, {'ForeName': 'Zoobia', 'Initials': 'Z', 'LastName': 'Daud', 'Affiliation': 'Department of Operative Dentistry, Armed Forces Institute of Dentistry, Rawalpindi, Pakistan.'}, {'ForeName': 'Syed Muzammil', 'Initials': 'SM', 'LastName': 'Hussain', 'Affiliation': 'Department of Operative Dentistry, Armed Forces Institute of Dentistry, Rawalpindi, Pakistan.'}, {'ForeName': 'Mohib', 'Initials': 'M', 'LastName': 'Ullah', 'Affiliation': 'Department of Operative Dentistry, Armed Forces Institute of Dentistry, Rawalpindi, Pakistan.'}, {'ForeName': 'Muzammil Jamil', 'Initials': 'MJ', 'LastName': 'Ahmed Rana', 'Affiliation': 'Department of Operative Dentistry, Armed Forces Institute of Dentistry, Rawalpindi, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[]
2038,32829585,Detection of Spinal Muscular Atrophy Using a Duplexed Real-Time PCR Approach With Locked Nucleic Acid-Modified Primers.,"BACKGROUND


Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disorder mainly caused by homozygous deletions that include exon 7 of the survival motor neuron 1 (SMN1) gene. A nearby paralog gene, SMN2, obstructs the specific detection of SMN1. We optimized a duplexed real-time PCR approach using locked nucleic acid (LNA)-modified primers to specifically detect SMN1.
METHODS


An LNA-modified primer pair with 3' ends targeting SMN1 specific sites c.835-44g and c.840C was designed, and its specificity was examined by real-time PCR and Sanger Sequencing. A duplexed real-time PCR approach for amplifying SMN1 and control gene albumin (ALB) was developed. A randomized double-blind trial with 97 fresh peripheral blood samples and 25 dried blood spots (DBS) was conducted to evaluate the clinical efficacy of the duplexed approach. This new approach was then used to screen 753 newborn DBS.
RESULTS


The LNA-modified primers exhibited enhanced specificity and 6.8% increased efficiency for SMN1 amplification, compared with conventional primers. After stabilizing the SMN1 test by optimizing the duplexed real-time PCR approach, a clinical trial validated that the sensitivity and specificity of our new approach for detecting SMA patients and carriers was 100%. Using this new approach, 15 of the screened 753 newborns were identified as carriers via DBS, while the rest were identified as normal individuals. These data reveal a carrier rate of 1.99% in Hunan province, South Central China.
CONCLUSIONS


We have developed a novel, specific SMN1 detection approach utilizing real-time PCR with LNA-modified primers, which could be applied to both prenatal carrier and newborn screening.",2021,"The LNA-modified primers exhibited enhanced specificity and 6.8% increased efficiency for SMN1 amplification, compared with conventional primers.",['screen 753 newborn DBS'],"['Duplexed Real-Time PCR Approach With Locked Nucleic Acid-Modified Primers', '97 fresh peripheral blood samples and 25 dried blood spots (DBS']",[],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1311713', 'cui_str': 'locked nucleic acid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",[],753.0,0.191072,"The LNA-modified primers exhibited enhanced specificity and 6.8% increased efficiency for SMN1 amplification, compared with conventional primers.","[{'ForeName': 'Jianyan', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Center for Medical Genetics & Hunan Key Laboratory of Medical Genetics, School of Life Sciences, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Center for Medical Genetics & Hunan Key Laboratory of Medical Genetics, School of Life Sciences, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'Laboratory of Molecular Genetics, Hunan Jiahui Genetics Hospital, Changsha, Hunan, China.'}, {'ForeName': 'Sijing', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Center for Medical Genetics & Hunan Key Laboratory of Medical Genetics, School of Life Sciences, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Center for Medical Genetics & Hunan Key Laboratory of Medical Genetics, School of Life Sciences, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Desheng', 'Initials': 'D', 'LastName': 'Liang', 'Affiliation': 'Center for Medical Genetics & Hunan Key Laboratory of Medical Genetics, School of Life Sciences, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Center for Medical Genetics & Hunan Key Laboratory of Medical Genetics, School of Life Sciences, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lingqian', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Center for Medical Genetics & Hunan Key Laboratory of Medical Genetics, School of Life Sciences, Central South University, Changsha, Hunan, China.'}]",Annals of laboratory medicine,['10.3343/alm.2021.41.1.101']
2039,32829594,[Clinical study on the treatment of calculous renal colic through external physical vibration lithecbole under different position].,"Objective:  To observe the clinical efficacy of external physical vibration lithecbole (EPVL) in the treatment of calculous renal colic under different positions.  Method:  A total of 120 calculous renal colic patients who underwent EPVL from September 2018 to September 2019, were randomly divided into three groups utilizing random number table: supine position group, the lateral position group and the hybrid position group, with 40 cases in each group. Prior to the EPVL, each patient was given an intravenous injection of 20 mg furosemide. When the patients accumulated enough urine, they began to undergo EPVL. Numeric Rating Scale (NRS) was applied to assess the pain intensity before and after the treatment. Furthermore, all the patients were examined by B-ultrasound or urinary CT a day and a week after the treatment. The NRS score, side effects, stone discharge rate, time of pain relief, and pain recurrence rate were compared among different groups.  Results:  Prior to the treatment, there was no significant difference of the pain intensity among three groups ( P> 0.05). After the treatment, the pain intensity considerably alleviated in all the groups. The NRS score decreased by 4.05±0.24, 3.23±0.23 and 2.90±0.21 in supine, lateral and hybrid position groups, respectively. The time of pain relief was (8.88±0.46) min, (10.33±0.44) min and (10.38±0.50) min in supine, lateral and hybrid position groups, respectively. Overall, the efficacy of lateral position group was better than the other two groups in terms of speed and degree of pain relief ( P<  0.05). The total pain relief rate was 91.7%. However, the pain recurrence rate was 15.0% (6/40), 15.0% (6/40) and 12.5% (5/40) in supine, lateral and hybrid position groups, respectively, however, there was no significant difference among three groups ( P> 0.05). But the hybrid position group had a relatively low rate of pain recurrence. The aggregate stone discharge rate of three groups was 25.8% and 62.5% a day and a week after the treatment respectively. The calculus clearance rate of surgical day was 22.5% (9/40), 35% (14/40) and 20% (8/40) in supine, lateral and hybrid position groups, respectively. Moreover, the stone removal rate was 60% (24/40), 75% (30/40) and 52.5% (21/40) in supine, lateral and hybrid position groups, respectively. The result indicated that the supine position group had the highest stone discharge rate ( P< 0.05). Overall, there was no case with severe complications, and there was no significant difference of side effects among three groups ( P> 0.05).  Conclusion:  EPVL can safely and effectively improve calculous renal colic and assist the removal of stone. When calculous renal colic was treated under EPVL, the patients can benefit from all three positions, and thus it is crucial to decide which position is more appropriate in different scenarios.",2020,"Overall, the efficacy of lateral position group was better than the other two groups in terms of speed and degree of pain relief ( P<  0.05).","['calculous renal colic under different positions', '120 calculous renal colic patients who underwent EPVL from September 2018 to September 2019']","['random number table: supine position group, the lateral position group and the hybrid position group', 'external physical vibration lithecbole (EPVL', 'furosemide', 'external physical vibration lithecbole', 'EPVL']","['calculus clearance rate of surgical day', 'Numeric Rating Scale (NRS', 'pain recurrence rate', 'pain recurrence', 'stone removal rate', 'highest stone discharge rate', 'pain intensity', 'speed and degree of pain relief', 'aggregate stone discharge rate', 'side effects', 'time of pain relief', 'severe complications', 'calculous renal colic and assist the removal of stone', 'NRS score, side effects, stone discharge rate, time of pain relief, and pain recurrence rate', 'NRS score', 'total pain relief rate']","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",120.0,0.0180049,"Overall, the efficacy of lateral position group was better than the other two groups in terms of speed and degree of pain relief ( P<  0.05).","[{'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Chen', 'Affiliation': ""Department of Urology, Jiangshan People's Hospital/Jiangshan Branch of Sir Run Run Shaw Hospital of Zhejiang University, Jiangshan 324100, China.""}, {'ForeName': 'C Y', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, Jiangshan People's Hospital/Jiangshan Branch of Sir Run Run Shaw Hospital of Zhejiang University, Jiangshan 324100, China.""}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191216-02742']
2040,32829596,[The effects of vestibular rehabilitation training on the symptoms of vertigo and disability in patients with vestibular peripheral vertigo].,"Objective:  To compare the effects of vestibular rehabilitation training and drug therapy on the symptoms of vertigo and disability in patients with vestibular peripheral vertigo.  Methods:  This prospective study was enrolled 43 patients with vestibular peripheral vertigo who admitted to the outpatient department of Eye & ENT Hospital of Fudan University from January 2018 to December 2018. They were randomly divided into two groups: control group (drug treatment group) and experimental group (drug treatment combined rehabilitation training group). All patients filled in the first vertigo disability rating scale (DHI), specific activity balance confidence scale (ABC) and anxiety self-rating scale (SAS) on the day of treatment and at two, four and eight weeks after treatment intervention, and the data were statistically analyzed.  Results:  There was no significant difference in gender, age and body weight between the two groups ( P> 0.05). After treatment (Control group (4w) : DHI (45.5±30.6) , ABC (86.9±12.4) , SAS (37.9±8.2) Experimental group (8w) : DHI (34.8±28.5) , SAS (35.7±7.9) ) , the three scales of the two groups were better than before treatment (Control group: DHI (59.2±25.9) , ABC (79.7±16.7) ,SAS (41.1±6.8) ; Experimental group: DHI (55.2±20.5) , ABC (80.3±18.3) , SAS (41.9±9.1) ) . The comparison of data before and after treatment in each group according to treatment time indicated that DHI and ABC scores in the experimental group showed that the DHI and ABC scores of the experimental group changed significantly at 2 weeks after treatment, and the SAS scores changed at 4 weeks after treatment. The difference was statistically significant ( P< 0.05). However, there was a statistically significant difference between the control group DHI score 4 weeks after treatment and SAS score 8 weeks after treatment ( P< 0.05). ABC score did not show statistical difference ( P> 0.05).  Conclusion:  The subjective symptoms and anxiety of vertigo and disability in the two groups improved obviously after treatment. Compared with drug therapy alone, drug therapy combined with vestibular rehabilitation training can significantly improve patients' subjective symptoms of vertigo and disability, as well as their anxiety and depression, so as to improve their overall quality of life.",2020,"There was no significant difference in gender, age and body weight between the two groups ( P> 0.05).","['patients with vestibular peripheral vertigo', '43 patients with vestibular peripheral vertigo who admitted to the outpatient department of Eye & ENT Hospital of Fudan University from January 2018 to December 2018']","['vestibular rehabilitation training and drug therapy', 'vestibular rehabilitation training', 'control group (drug treatment group) and experimental group (drug treatment combined rehabilitation training']","['SAS scores', 'vertigo and disability', 'ABC score', ""patients' subjective symptoms of vertigo and disability"", 'gender, age and body weight', 'overall quality of life', 'subjective symptoms and anxiety of vertigo and disability', 'DHI and ABC scores', 'vertigo disability rating scale (DHI), specific activity balance confidence scale (ABC) and anxiety self-rating scale (SAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155501', 'cui_str': 'Peripheral vertigo'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451125', 'cui_str': 'Disability rating scale'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",43.0,0.017613,"There was no significant difference in gender, age and body weight between the two groups ( P> 0.05).","[{'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Otorhinolaryngology, Eye & ENT Hospital of Fudan University, Shanghai 200031, China.'}, {'ForeName': 'S X', 'Initials': 'SX', 'LastName': 'Xi', 'Affiliation': 'Department of Otorhinolaryngology, Eye & ENT Hospital of Fudan University, Shanghai 200031, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology, Eye & ENT Hospital of Fudan University, Shanghai 200031, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191202-02621']
2041,32829608,[Influence of silver ion dressing on central venous catheter-related infection in severe burn patients].,"Objective:  To investigate the influence of silver ion dressing on related infections induced by inserted central venous catheter through wounds in patients with severe burn.  Methods:  From June 2017 to December 2018, 90 severe burn patients who were admitted to the First Hospital of Hebei Medical University and met the inclusion criteria were included in this prospectively randomized control study. According to the random number table, they were divided into silver ion dressing group (30 patients, 20 males and 10 females, aged (37.2±3.4) years), sterile dressing group (30 patients, 18 males and 12 females, aged (35.2±4.1) years), and Anerdian dressing group (30 patients, 17 males and 13 females, aged (36.3±2.6) years). After admission, the patients in three groups were treated with a 16 G single-lumen central venous catheter inserted into the subclavian vein of burn wounds, with the depth of 19 cm. The puncture points of the patients in silver ion dressing group, sterile dressing group, and Anerdian dressing group were covered with silver ion medical antibacterial dressing, sterile dressing, and sterile gauze dressing infiltrated with Anerdian skin and mucous membrane washing and disinfecting solution, respectively. The patients in three groups underwent catheter maintenance and dressing change every 12 hours. The thousand-day infection rates of catheter outlet infection and catheter-related bloodstream infection (CRBSI), catheter indwelling days, and pathogen detection of the patients in three groups were counted. Data were statistically analyzed with chi-square test, one-way analysis of variance, least significant difference test, Fisher's exact probability test, and Bonferroni correction.  Results:  (1) The thousand-day infection rates of catheter outlet infection of patients in sterile dressing group and Anerdian dressing group were 22.29‰ (7/314) and 20.83‰ (7/336), respectively, which were similar ( P >0.05), and both were significantly higher than 1.54‰ (1/651) in silver ion dressing group ( P <0.01). The thousand-day infection rates of CRBSI of patients in sterile dressing group and Anerdian dressing group were 25.48‰ (8/314) and 20.83‰ (7/336), respectively, which were similar ( P >0.05), and both were significantly higher than 1.54‰ (1/651) in silver ion dressing group ( P <0.01). The catheter indwelling days of patients in sterile dressing group and Anerdian dressing group were similar ( P >0.05), and both were significantly shorter than the days in silver ion dressing group ( P <0.01). (2) A total of 16 cases of CRBSI occurred in all the patients in 3 groups. A total of 16 pathogenic bacteria were isolated from catheter tip attachment microbial culture and blood microbial culture. The detections rates of pathogenic bacteria of patients in sterile dressing group and Anerdian dressing group were significantly higher than the rate in silver ion dressing group ( P <0.05).  Conclusions:  For severe burn patients, the use of silver ion dressings in the maintenance of central venous catheters inserted through wounds can effectively reduce the rate of central venous catheter-related infections and extend the catheter indwelling days.",2020,"The catheter indwelling days of patients in sterile dressing group and Anerdian dressing group were similar ( P >0.05), and both were significantly shorter than the days in silver ion dressing group ( P <0.01).","['patients with severe burn', 'severe burn patients', 'Methods:  From June 2017 to December 2018, 90 severe burn patients who were admitted to the First Hospital of Hebei Medical University and met the inclusion criteria', '30 patients, 20 males and 10 females, aged (37.2±3.4) years), sterile dressing group (30 patients, 18 males and 12 females, aged (35.2±4.1) years), and Anerdian dressing group (30 patients, 17 males and 13 females, aged (36.3±2.6) years']","['silver ion medical antibacterial dressing, sterile dressing, and sterile gauze dressing infiltrated with Anerdian skin and mucous membrane washing and disinfecting solution', 'silver ion dressing', '16 G single-lumen central venous catheter inserted into the subclavian vein', 'silver ion dressing group', 'silver ion dressings']","['infection rates of catheter outlet infection and catheter-related bloodstream infection (CRBSI), catheter indwelling days, and pathogen detection', 'infection rates of catheter outlet infection', 'detections rates of pathogenic bacteria', 'CRBSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0456636', 'cui_str': '16G'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C2886794', 'cui_str': 'Catheter related bloodstream infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",16.0,0.0246141,"The catheter indwelling days of patients in sterile dressing group and Anerdian dressing group were similar ( P >0.05), and both were significantly shorter than the days in silver ion dressing group ( P <0.01).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Burns and Plastic Surgery, the First Hospital of Hebei Medical University, Burns Treatment Project Technology Research Center of Hebei Province, Shijiazhuang 050031, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Burns and Plastic Surgery, the First Hospital of Hebei Medical University, Burns Treatment Project Technology Research Center of Hebei Province, Shijiazhuang 050031, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Burns and Plastic Surgery, the First Hospital of Hebei Medical University, Burns Treatment Project Technology Research Center of Hebei Province, Shijiazhuang 050031, China.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Feng', 'Affiliation': 'Department of Burns and Plastic Surgery, the First Hospital of Hebei Medical University, Burns Treatment Project Technology Research Center of Hebei Province, Shijiazhuang 050031, China.'}, {'ForeName': 'Q F', 'Initials': 'QF', 'LastName': 'Zhang', 'Affiliation': 'Department of Burns and Plastic Surgery, the First Hospital of Hebei Medical University, Burns Treatment Project Technology Research Center of Hebei Province, Shijiazhuang 050031, China.'}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20190519-00246']
2042,32829654,"Casein hydrolysate containing milk-derived peptides reduces facial pigmentation partly by decreasing advanced glycation end products in the skin: A randomized, double-blind, placebo-controlled trial.","Casein hydrolysate has been shown to improve arterial stiffness as estimated by brachial-ankle pulse wave velocity in untreated hypertensive patients. Facial pigmentation is associated with atherosclerosis, both of which are supposed to be modulated by tissue accumulation of advanced glycation end products. However, effects of casein hydrolysate on facial pigmentation and advanced glycation end products remain largely unknown. This randomized, double-blind, placebo-controlled trial evaluated whether and how casein hydrolysate improves facial pigmentation in 80 non-hypertensive Japanese patients. Study participants were randomly assigned to receive either active tablets containing casein hydrolysate or placebo for 48 weeks. Facial pigmentation area, brachial-ankle pulse wave velocity, and skin accumulation levels of advanced glycation end products were evaluated by Robo Skin Analyzer RSA50S II, volume-plethysmographic apparatus, and AGE Reader, respectively at baseline and at the end of the intervention. Treatment with casein hydrolysate, but not placebo significantly reduced triglycerides and facial pigmentation area. There were significant differences of changes in triglycerides, facial pigmentation area, skin accumulation levels of advanced glycation end products, and brachial-ankle pulse wave velocity between the two groups. Furthermore, changes in triglycerides and skin accumulation levels of advanced glycation end products were positively and independently associated with those in facial pigmentation area, whereas changes in brachial-ankle pulse wave velocity were not. Our present study suggests that casein hydrolysate reduces facial pigmentation area in non-hypertensive participants partly by decreasing skin accumulation levels of advanced glycation end products.",2020,"There were significant differences of changes in triglycerides, facial pigmentation area, skin accumulation levels of advanced glycation end products, and brachial-ankle pulse wave velocity between the two groups.","['untreated hypertensive patients', '80 non-hypertensive Japanese patients']","['casein hydrolysate', 'Casein hydrolysate containing milk-derived peptides', 'Casein hydrolysate', 'placebo', 'active tablets containing casein hydrolysate or placebo']","['Facial pigmentation area, brachial-ankle pulse wave velocity, and skin accumulation levels of advanced glycation end products', 'triglycerides and facial pigmentation area', 'triglycerides, facial pigmentation area, skin accumulation levels of advanced glycation end products, and brachial-ankle pulse wave velocity', 'facial pigmentation', 'brachial-ankle pulse wave velocity', 'facial pigmentation area', 'arterial stiffness', 'facial pigmentation and advanced glycation', 'Robo Skin Analyzer RSA50S II, volume-plethysmographic apparatus, and AGE Reader', 'triglycerides and skin accumulation levels of advanced glycation end products']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0054845', 'cui_str': 'Casein hydrolysate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",80.0,0.315026,"There were significant differences of changes in triglycerides, facial pigmentation area, skin accumulation levels of advanced glycation end products, and brachial-ankle pulse wave velocity between the two groups.","[{'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Igase', 'Affiliation': 'Ehime University Graduate School of Medicine, 38050, 454 Shitsukawa, Toon, Ehime, Japan, 791-0295; migase@m.ehime-u.ac.jp.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Ehime University Graduate School of Medicine, 38050, Toon, Ehime, Japan; mitchiecandy@gmail.com.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Igase', 'Affiliation': 'Ehime University Graduate School of Medicine, 38050, Toon, Ehime, Japan; igase@sadamoto-hsp.jp.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Ehime University Graduate School of Medicine, 38050, Toon, Ehime, Japan; pigase1212@yahoo.co.jp.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Senzaki', 'Affiliation': 'Ehime University Graduate School of Medicine, 38050, Toon, Ehime, Japan; migase1212@yahoo.co.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ochi', 'Affiliation': 'Ehime University Graduate School of Medicine, 38050, Toon, Ehime, Japan; kigase9119@yahoo.co.jp.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Ohyagi', 'Affiliation': 'Ehime University Graduate School of Medicine, 38050, Toon, Ehime, Japan; mitchiecandy@i.softbank.jp.'}, {'ForeName': 'Sho-Ichi', 'Initials': 'SI', 'LastName': 'Yamagishi', 'Affiliation': 'Showa University Graduate School of Medicine School of Medicine, 38557, Shinagawa-ku, Tokyo, Japan; shoichi@med.showa-u.ac.jp.'}]",Rejuvenation research,['10.1089/rej.2020.2343']
2043,32829666,Effects of Intensive Versus Standard Office-Based Hypertension Treatment Strategy on White-Coat Effect and Masked Uncontrolled Hypertension: From the SPRINT ABPM Ancillary Study.,"Guidelines recommend using out-of-office blood pressure (BP) measurements to confirm the diagnoses of hypertension and in the titration of antihypertensive medication. The prevalence of out-of-office BP phenotypes for an office systolic/diastolic BP goal <140/90 mm Hg has been reported. However, the prevalence of these phenotypes when targeting an office systolic/diastolic BP goal <120/80 is unknown. The SPRINT (Systolic Blood Pressure Intervention Trial) Ambulatory BP Ancillary study evaluated out-of-office BP using ambulatory BP monitoring in 897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg). We used office and daytime BP to assess the proportion of participants with white-coat effect (standard target: office BP ≥140/90 mm Hg and daytime BP <135/85 mm Hg versus intensive target: office BP ≥120/80 mm Hg and daytime BP <120/80 mm Hg) and masked uncontrolled hypertension (standard target: office BP <140/90 mm Hg and daytime BP ≥135/85 mm Hg versus intensive target: office BP <120/80 mm Hg and daytime BP ≥120/80 mm Hg) in each treatment arm. The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups. Among participants with uncontrolled office BP, white-coat effect was present in 20% and 23% in the intensive and standard groups, respectively. Among participants with controlled office BP, masked uncontrolled hypertension was present in 62% and 56% in the intensive and standard groups, respectively. In conclusion, a more intensive BP target resulted in a similar proportion of patients with white-coat effect and masked uncontrolled hypertension compared with a standard target.",2020,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","['897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg', 'White-Coat Effect and Masked Uncontrolled Hypertension', 'participants with white-coat effect (standard target']",['Intensive Versus Standard Office-Based Hypertension Treatment Strategy'],"['prevalence of white-coat effect and masked uncontrolled hypertension', 'uncontrolled hypertension']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]",27.0,0.101849,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","[{'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Cohen', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham (P.M.).'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'The Columbia Hypertension Center, Columbia University, New York, NY (L.P.C., D.S.).'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15300']
2044,32829739,Advancement of a standardised enteral feeding protocol in functional single ventricle patients following stage I palliation using cerebro-somatic near-infrared spectroscopy.,"INTRODUCTION


Infants with single ventricle following stage I palliation are at risk for poor nutrition and growth failure. We hypothesise a standardised enteral feeding protocol for these infants that will result in a more rapid attainment of nutritional goals without an increased incidence of gastrointestinal co-morbidities.
MATERIALS AND METHODS


Single-centre cardiac ICU, prospective case series with historical comparisons. Feeding cohort consisted of consecutive patients with a single ventricle admitted to cardiac ICU over 18 months following stage I palliation (n = 33). Data were compared with a control cohort and admitted to the cardiac ICU over 18 months before feeding protocol implementation (n = 30). Feeding protocol patients were randomised: (1) protocol with cerebro-somatic near-infrared spectroscopy feeding advancement criteria (n = 17) or (2) protocol without cerebro-somatic near-infrared spectroscopy feeding advancement criteria (n = 16).
RESULTS


Median time to achieve goal enteral volume was significantly higher in the control compared to feeding cohort. There were no significant differences in enteral feeds being held for feeding intolerance or necrotising enterocolitis between cohorts. Feeding cohort had significant improvements in discharge nutritional status (weight, difference admit to discharge weight, weight-for-age z score, volume, and caloric enteral nutrition) and late mortality compared to the control cohort. No infants in the feeding group with cerebro-somatic near-infrared spectroscopy developed necrotising enterocolitis versus 4/16 (25%) in the feeding cohort without cerebro-somatic near-infrared spectroscopy (p = 0.04).
CONCLUSIONS


A feeding protocol is a safe and effective means of initiating and advancing enteral nutrition in infants following stage I palliation and resulted in improved nutrition delivery, weight gain, and nourishment status at discharge without increased incidence of gastrointestinal co-morbidities.",2020,There were no significant differences in enteral feeds being held for feeding intolerance or necrotising enterocolitis between cohorts.,"['functional single ventricle patients following stage I palliation using cerebro-somatic near-infrared spectroscopy', 'Infants with single ventricle following stage', 'consecutive patients with a single ventricle admitted to cardiac ICU over 18 months following stage I palliation (n = 33']","['standardised enteral feeding protocol', 'protocol with cerebro-somatic near-infrared spectroscopy feeding advancement criteria (n = 17) or (2) protocol without cerebro-somatic near-infrared spectroscopy feeding advancement criteria']","['discharge nutritional status (weight, difference admit to discharge weight, weight-for-age z score, volume, and caloric enteral nutrition) and late mortality', 'Median time to achieve goal enteral volume', 'necrotising enterocolitis']","[{'cui': 'C2732741', 'cui_str': 'Functional single ventricle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152424', 'cui_str': 'Common ventricle'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272277', 'cui_str': 'Goal achieved'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]",33.0,0.0458667,There were no significant differences in enteral feeds being held for feeding intolerance or necrotising enterocolitis between cohorts.,"[{'ForeName': 'Tia T', 'Initials': 'TT', 'LastName': 'Raymond', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Valle', 'Affiliation': ""HCA Research Institute at Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Garza', 'Affiliation': ""Children's Health, Division of Cardiology, Dallas, TX, USA.""}, {'ForeName': 'Samrat', 'Initials': 'S', 'LastName': 'Yeramaneni', 'Affiliation': ""HCA Research Institute at Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Wurtz', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Sample', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kozak', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stigall', 'Affiliation': ""Pediatric Critical Care, Cook Children's Hospital, Fort Worth, TX, USA.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gatlin', 'Affiliation': ""Department of Pediatrics, Division of Cardiology, Arkansas Children's Hospital, Little Rock, AR, USA.""}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Burton', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}]",Cardiology in the young,['10.1017/S104795112000253X']
2045,32829745,Face masks for the prevention of COVID-19 - Rationale and design of the randomised controlled trial DANMASK-19.,"INTRODUCTION


The coronavirus disease 19 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), progresses globally, and means to reduce the transmission are needed. In the community, the use of face masks is increasing world-wide, but documentation for the efficacy of this remedy is lacking. This trial investigates whether the use of face masks in the community will reduce wearers' risk of SARS-CoV-2 infection.
METHODS


This study will be a two-arm, unblinded, randomised controlled trial. We will include adults (>18 years of age) without prior confirmed COVID-19 or symptoms suggestive of COVID-19, who spend more than three hours per day outside the home with exposure to other people. A total of 6,000 participants are randomly assigned 1:1 to use face masks or not for a 30-day period during the pandemic. Participants will perform self-testing; quick test for SARS-CoV-2 antibodies (immunoglobulin M (IgM) and immunoglobulin G (IgG)) (the Livzon lateral flow test) and oropharyngeal/nasal swabs for viral detection using polymerase chain reaction (PCR). The primary endpoint following the 30-day study period is the difference in the number of SARS-CoV-2-infected individuals between the two study groups as assessed by a positive nasopharyngeal swap, a positive antibody test or a hospital-based diagnosis of SARS-CoV-2 infection.
CONCLUSIONS


We will study whether a face mask protects the wearer of the mask against SARS-CoV-2 infection. The findings are expected to apply to the present pandemic and to future viral outbreaks and to provide evidence for authority recommendations across the world.
FUNDING


This study was funded by Salling Fondene.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04337541.",2020,Participants will perform self-testing; quick test for SARS-CoV-2 antibodies (immunoglobulin M (IgM) and immunoglobulin G (IgG)),"['6,000 participants', 'adults (>18 years of age) without prior confirmed COVID-19 or symptoms suggestive of COVID-19, who spend more than three hours per day outside the home with exposure to other people']",['polymerase chain reaction (PCR'],"['SARS-CoV-2 antibodies (immunoglobulin M (IgM) and immunoglobulin G (IgG', 'positive antibody test or a hospital-based diagnosis of SARS-CoV-2 infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",6000.0,0.266451,Participants will perform self-testing; quick test for SARS-CoV-2 antibodies (immunoglobulin M (IgM) and immunoglobulin G (IgG)),"[{'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'henning.bundgaard@regionh.dk.'}, {'ForeName': 'Johan Skov', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': ''}, {'ForeName': 'Daniel Emil Tadeusz', 'Initials': 'DET', 'LastName': 'Raaschou-Pedersen', 'Affiliation': ''}, {'ForeName': 'Anton Friis', 'Initials': 'AF', 'LastName': 'Mariager', 'Affiliation': ''}, {'ForeName': 'Natasja', 'Initials': 'N', 'LastName': 'Schytte', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Buchwald', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Todsen', 'Affiliation': ''}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Skovgaard', 'Affiliation': ''}, {'ForeName': 'Romona', 'Initials': 'R', 'LastName': 'Trebbien', 'Affiliation': ''}, {'ForeName': 'Mikkel Porsborg', 'Initials': 'MP', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ullum', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': ''}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Iversen', 'Affiliation': ''}]",Danish medical journal,[]
2046,32829900,"""Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial"".",,2020,,[],['Botulinum Toxin'],['Poststroke Postural Sway'],[],"[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}]",,0.79864,,"[{'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, Yokohama, Kanagawa, Japan; Systematic Review Workshop Peer Support Group (SRWS-PSG), Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiroshita', 'Affiliation': 'Systematic Review Workshop Peer Support Group (SRWS-PSG), Osaka, Japan; Department of Pulmonology, Kameda Medical Center, Kamogawa, Chiba, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Systematic Review Workshop Peer Support Group (SRWS-PSG), Osaka, Japan; Department of Nephrology and Dialysis, Kyoritsu Hospital, Kawanishi, Japan; Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.027']
2047,32829925,[Effects of music therapy on pain and oxidative stress in oocyte pick-up: a randomized clinical trial].,"BACKGROUND AND OBJECTIVE


The aim was to investigate the effects of Turkish classical music on pain and oxidative stress in patients undergoing oocyte pick-up.
METHODS


The study was a randomized, controlled trial. The groups included were Group NM (Non-Music), control group; Group PM, which comprised patients who listened to music before the operation; and Group CM, which comprised patients who listened to music both before and during the operation. Blood was drawn prior to the operation to measure the oxidative stress values. Pain, hemodynamic parameters, oxidative stress values were assessed postoperatively.
RESULTS


The number of patients requiring additional propofol was higher in Group PM than in Groups NM and CM (p=0.003). The postoperative Visual Analog Scale (VAS) score were lower in Groups PM and CM than in Group NM (p=0.001, p=0.007) in the 1 st  and 60 th  minutes. The postoperative VAS score was lower in Group CM than in Group NM (p=0.045) in the 5 th  minute. The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045). The postoperative blood glutathione peroxidase values were significantly higher in Groups PM and CM than in Group NM (p=0.001). The postoperative catalase values were significantly higher in Groups PM and CM than in Group NM (p=0.008 and p ≤0.001). The preoperative malondialdehyde values were significantly lower in Groups PM and CM than in Group NM. The preoperative nitric oxide values were higher in Groups PM and CM than in Group NM (p ≤0.001), whereas the postoperative nitric oxide values were lower in Groups PM and CM than in Group NM (p ≤0.001).
CONCLUSION


Turkish classical music has beneficial effects on pain and oxidative stress in oocyte pick-up patients.",2020,The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045).,"['patients undergoing oocyte pick-up', 'oocyte pick-up']","['control group; Group PM, which comprised patients who listened to music before the operation; and Group CM', 'music therapy', 'Turkish classical music']","['postoperative VAS score', 'postoperative blood glutathione peroxidase values', 'oxidative stress values', 'postoperative catalase values', 'preoperative malondialdehyde values', 'Pain, hemodynamic parameters, oxidative stress values', 'number of patients requiring additional propofol', 'postoperative additional analgesic requirements', 'postoperative nitric oxide values', 'preoperative nitric oxide values', 'postoperative Visual Analog Scale (VAS) score', 'pain and oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0356329,The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Orak', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Onikişubat, Turquia. Electronic address: dryavuzorak@hotmail.com.'}, {'ForeName': 'Suleyman Murat', 'Initials': 'SM', 'LastName': 'Bakacak', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Obstetrics and Gynecology, Onikişubat, Turquia.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Yaylali', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Histology Department, Onikişubat, Turquia.'}, {'ForeName': 'Fatma Inanc', 'Initials': 'FI', 'LastName': 'Tolun', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Biochemistry, Onikişubat, Turquia.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kiran', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Obstetrics and Gynecology, Onikişubat, Turquia.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Boran', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Onikişubat, Turquia.'}, {'ForeName': 'Akif Hakan', 'Initials': 'AH', 'LastName': 'Kurt', 'Affiliation': 'Bolu Abant Izzet Baysal University, Faculty of Medicine, Medical Pharmacology, Bolu, Turquia.'}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Doganer', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Biostatistics and Medical Informatics, Onikişubat, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.015']
2048,32829942,"Plantar Myofascial Mobilization: Plantar Area, Functional Mobility, and Balance in Elderly Women: A Randomized Clinical Trial.","OBJECTIVE


The purpose of this study was to evaluate the effects of plantar myofascial mobilization (PMM) on the plantar area, balance, and functional mobility of elderly women.
METHODS


In this randomized, single-blind, placebo-controlled clinical trial, elderly women with maintained independent orthostatism were recruited from the community and randomly separated into a PMM group (MG = 15), a placebo group (PG = 13), or a control group (control group = 14). Vigorous PMM and soft PMM were performed in the MG and PG, respectively, for 5 days with a rest day between each. The measures of plantar area, single leg stance test with open eye and closed eye, and timed up-and-go test were performed pre-PMM, immediately post-PMM, and on the last day of the protocol. The control group only underwent evaluation before and on the last day of the protocol. The sample size was calculated, and, for quantitative variables, a mixed analysis of variance was used for repeated measurements (split plot), followed by the Bonferroni post hoc test. The results were analyzed in 2 ways: 3 groups at 2 moments (pre, last day), and 2 groups at 3 moments (pre, post, last day).
RESULTS


Forty-two elderly women with mean age of 69.03 ± 3.32 years were included in the study. The vigorous MMP showed a statistically significant increase in the plantar area of the right foot (3 groups: P = .49) and single leg stance test with open eye time (2 groups: P = .002; 3 groups: P = .001), and a decrease in the timed up-and-go time (2 groups: P = .04; 3 groups: P = .0001).
CONCLUSION


The vigorous PMM showed increases of the plantar area and promoted beneficial effects on functional mobility and body balance.",2020,"The vigorous MMP showed a statistically significant increase in the plantar area of the right foot (3 groups: P = .49) and single leg stance test with open eye time (2 groups: P = .002; 3 groups: P = .001), and a decrease in the timed up-and-go time (2 groups: P = .04; 3 groups: P = .0001).
","['Forty-two elderly women with mean age of 69.03 ± 3.32 years were included in the study', 'elderly women with maintained independent orthostatism', 'Elderly Women', 'elderly women']","['plantar myofascial mobilization (PMM', 'PMM', 'placebo']","['timed up-and-go time', 'functional mobility and body balance', 'single leg stance test with open eye time', 'plantar area of the right foot', 'plantar area, single leg stance test with open eye and closed eye, and timed up-and-go test', 'plantar area, balance, and functional mobility']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517689', 'cui_str': '3.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1299583', 'cui_str': 'Independent'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0230460', 'cui_str': 'Structure of right foot'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",42.0,0.0348885,"The vigorous MMP showed a statistically significant increase in the plantar area of the right foot (3 groups: P = .49) and single leg stance test with open eye time (2 groups: P = .002; 3 groups: P = .001), and a decrease in the timed up-and-go time (2 groups: P = .04; 3 groups: P = .0001).
","[{'ForeName': 'Ana E Z', 'Initials': 'AEZ', 'LastName': 'Stroppa-Marques', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil. Electronic address: anastropa@hotmail.com.'}, {'ForeName': 'João S Melo', 'Initials': 'JSM', 'LastName': 'Neto', 'Affiliation': 'Faculty of Physical Therapy and Occupational Therapy, Health Science Institute, Federal University of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Cristiane R', 'Initials': 'CR', 'LastName': 'Pedroni', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}, {'ForeName': 'Beatriz M', 'Initials': 'BM', 'LastName': 'Tozim', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}, {'ForeName': 'Eduardo F B', 'Initials': 'EFB', 'LastName': 'Chagas', 'Affiliation': 'Department of Physical Education, University of Marilia, Marília, São Paulo, Brazil.'}, {'ForeName': 'Flávia R F', 'Initials': 'FRF', 'LastName': 'Navega', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}, {'ForeName': 'Marcelo T', 'Initials': 'MT', 'LastName': 'Navega', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.11.007']
2049,32829943,Predictors for Positive Response to Home Kinematic Training in Chronic Neck Pain.,"OBJECTIVES


There is strong evidence for exercise therapy in neck pain, but a wide variety of protocols. Predictors for outcome are unknown and current practice is based on trial and error. The objective of this study was to identify predictors for response to home kinematic training (KT) considering improvement in both self-reported and kinematic measures.
METHODS


A continuing analysis of data from the second phase of a randomized controlled trial, which included 4 weeks of KT using laser or virtual reality, with baseline, postintervention, and 3-month follow-up measures. Positive self-reported response was defined as a ≥50% pain reduction, ≥7% reduction in neck disability index (NDI), or a global perceived effect of 3 to 5 of 5. A second model defined improvement by ≥40% increase in cervical velocity.
RESULTS


Data were retrieved from 79 participants with chronic neck pain who completed the postintervention evaluation and 52 who completed the 3-month follow-up. Self-reported response was 71% to 73% and kinematic response was 41% to 46%. Prediction models indicated an immediate increase in self-reported measures in men with NDI ≥ 20% slower (≤65°/s), and less accurate (≥16° error) cervical motion at baseline. In the longer term, older patients with higher NDI seemed to benefit more. In the second model, no factors significantly predicted improvement in kinematic measures at either time point.
CONCLUSION


A high positive response rate to home KT was found by self-reported criteria. Males with poorer clinical and kinematic presentation at baseline, that is greater disability and slower neck motion, were more likely to respond.",2020,"Positive self-reported response was defined as a ≥50% pain reduction, ≥7% reduction in neck disability index (NDI), or a global perceived effect of 3 to 5 of 5.","['Chronic Neck Pain', 'older patients with higher NDI', '79 participants with chronic neck pain who completed the postintervention evaluation and 52 who completed the 3-month follow-up']","['Home Kinematic Training', 'home kinematic training (KT']","['kinematic measures', 'cervical velocity', 'neck disability index (NDI', 'kinematic response']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",79.0,0.0635534,"Positive self-reported response was defined as a ≥50% pain reduction, ≥7% reduction in neck disability index (NDI), or a global perceived effect of 3 to 5 of 5.","[{'ForeName': 'Hilla', 'Initials': 'H', 'LastName': 'Sarig Bahat', 'Affiliation': 'Department of Physical Therapy, University of Haifa, Haifa, Israel. Electronic address: hbahat@research.haifa.ac.il.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Hadar', 'Affiliation': 'Department of Physical Therapy, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Treleaven', 'Affiliation': 'Division of Physiotherapy, University of Queensland, St. Lucia, Queensland, Australia.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.12.008']
2050,32829945,Chronic Resistance Exercise Improves Functioning and Reduces Toll-Like Receptor Signaling in Elderly Patients With Postoperative Deconditioning.,"OBJECTIVE


Elderly patients continue to experience low levels of mobility during and following postoperative hospitalization that lead to persistent physical decline. Therefore, here we compared chronic resistance (CR) exercise against chronic aerobic (CA) exercise in ameliorating postoperative functioning and reducing proinflammatory muscular Toll-like receptor (TLR)-associated signaling in elderly postoperative patients.
METHODS


We conducted a prospective, randomized trial comparing the effects of 3 exercise programs (CR, CA, and CR + CA) in 66 elderly patients recovering from recent hip, femur, or pelvic fracture repair surgery. The primary outcomes were changes in anatomic/physical performance parameters (ie, maximal oxygen intake, endurance, quadriceps cross-sectional area, and maximum knee-extensor force). The secondary outcomes were changes in TLR/nuclear factor kappa beta signaling pathway marker expression.
RESULTS


Three of the 4 anatomic/physical performance parameters significantly improved for the CR and CR + CA cohorts. Muscular expression of myeloid differentiation primary response gene 88, transforming growth factor beta-activated kinase 1 (TLR signaling pathway markers), p50, p65, tumor necrosis factor α, and interleukin 6 (nuclear factor kappa beta signaling pathway markers) all showed significant reductions after CR and CR + CA. Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
CONCLUSIONS


Three months of CR or CR + CA improves maximal oxygen consumption, quadriceps cross-sectional area, and maximum knee-extensor force while lowering muscular proinflammatory signaling markers in elderly adults with postoperative deconditioning.",2020,"Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
","['elderly postoperative patients', 'Elderly Patients With Postoperative Deconditioning', 'elderly adults with postoperative deconditioning', 'Elderly patients', '66 elderly patients recovering from recent hip, femur, or pelvic fracture repair surgery']","['\u202fCA', 'Chronic Resistance Exercise', 'chronic resistance (CR) exercise against chronic aerobic (CA) exercise', '3 exercise programs (CR, CA, and CR\u202f+\u202fCA']","['changes in TLR/nuclear factor kappa beta signaling pathway marker expression', 'changes in anatomic/physical performance parameters (ie, maximal oxygen intake, endurance, quadriceps cross-sectional area, and maximum knee-extensor force', 'maximal oxygen consumption, quadriceps cross-sectional area, and maximum knee-extensor force', 'Muscular expression of myeloid differentiation primary response gene 88, transforming growth factor beta-activated kinase 1 (TLR signaling pathway markers), p50, p65, tumor necrosis factor α, and interleukin 6 (nuclear factor kappa beta signaling pathway markers', 'physical performance parameters', 'Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0379816', 'cui_str': 'MAP kinase kinase kinase 7'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}]",66.0,0.0703044,"Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
","[{'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Training, Sports Institute, Zhengzhou University, Zhengzhou, Henan, China. Electronic address: m18530021718@163.com.'}, {'ForeName': 'Xiaohai', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Rehabilitation Medicine, Hainan Provincial People's Hospital, Haikou, Hainan, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Rehabilitation, Sports Institute, Zhengzhou University, Zhengzhou, Henan, China.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2020.01.001']
2051,32830127,12-month randomised trial of 360° and 180° Schlemm's canal incisions in suture trabeculotomy ab interno for open-angle glaucoma.,"BACKGROUND/AIMS


To perform a 12-month comparison between the different extents and locations of Schlemm's canal incisions during suture trabeculotomy ab interno for open-angle glaucoma (OAG).
METHODS


This is a prospective, single-centre, three-arm randomised trial. A total of 99 eyes of 99 patients were randomly assigned to one of three groups: the 360° incision group (n=34), the upper-180° incision group (n=34) and the lower-180° incision group (n=31). Intraocular pressure (IOP), number of medications and complications were evaluated until 12 months after surgery. Surgical success (with or without medication) was defined as IOP ≤21 mmHg and ≥20% IOP reduction (criterion A) or IOP ≤15 mmHg and ≥20% IOP reduction (criterion B).
RESULTS


The mean IOP (±SD) in all eyes was reduced from 18.6 (5.9) mmHg with 3.1 (1.1) medications to 13.7 (3.4) mmHg (20.8% reduction;  p <0.001) with 1.4 (1.3) medications (p<0.001) at postoperative 12-month. Each group produced comparable mean reductions in both IOP and the number of medications throughout 12 months of follow-up. Kaplan-Meier cumulative survival analyses showed no significance among these three groups for criterion A and criterion B. Postoperative hyphema with niveau formation occurred significantly more in the 360° group than in the lower-180° group (p=0.031).
CONCLUSIONS


The different extents and locations of Schlemm's canal incisions during suture trabeculotomy ab interno for OAG, including the 360° incision, the upper-180° incision and the lower-180° incision, do not affect both the IOP reduction and the medications throughout 12 months of follow-up.
TRIAL REGISTRATION NUMBER


UMIN000021169.",2020,"Kaplan-Meier cumulative survival analyses showed no significance among these three groups for criterion A and criterion B. Postoperative hyphema with niveau formation occurred significantly more in the 360° group than in the lower-180° group (p=0.031).
","['A total of 99 eyes of 99 patients', '360° and']","['suture trabeculotomy ab interno for OAG, including the 360° incision', 'upper-180° incision group', 'suture trabeculotomy ab interno', 'lower-180° incision group']","['Intraocular pressure (IOP), number of medications and complications', 'criterion B. Postoperative hyphema with niveau formation', 'mean IOP (±SD', 'Surgical success', 'IOP reduction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319607', 'cui_str': '360'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020581', 'cui_str': 'Hyphema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",99.0,0.148632,"Kaplan-Meier cumulative survival analyses showed no significance among these three groups for criterion A and criterion B. Postoperative hyphema with niveau formation occurred significantly more in the 360° group than in the lower-180° group (p=0.031).
","[{'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Sato Eye and Internal Medicine Clinic, Arao, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kawaji', 'Affiliation': 'Sato Eye and Internal Medicine Clinic, Arao, Japan kawag@white.plala.or.jp.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316624']
2052,32830164,Microleakage of resin infiltration in artificial white-spot lesions.,"This study examined the effectiveness of resin infiltration in inhibiting microleakage from artificial white-spot lesions (AWL) in enamel. Fifty sound extracted premolars were selected and randomly divided into five groups (n = 10 each). Group 1 included sound teeth. In contrast, an AWL was created in all specimens in groups 2 to 5, as follows-Group 2: AWL with no treatment; Group 3: AWL treated with resin infiltration; Group 4: AWL treated with resin infiltration and 5,000 cycles of thermocycling; Group 5: AWL treated with resin infiltration and 10,000 cycles of thermocycling. All specimens were then coated with nail varnish, except for a 4 × 4 mm 2  area on the buccal surface (the measurement area), immersed in 2% methylene blue solution, and sectioned buccolingually. Microleakage was evaluated with a stereomicroscope. Data were analyzed by using the Kruskal-Wallis test and Bonferroni post-hoc correction. Application of resin infiltrant reduced microleakage in AWL. No microleakage was seen in Group 3, and differences between Groups 3, 4, and 5 were not significant (P > 0.05). The resin infiltration technique appears to aid in sealing enamel AWL and may help provide long-term protection against microleakage in enamel AWL.",2020,"No microleakage was seen in Group 3, and differences between Groups 3, 4, and 5 were not significant (P > 0.05).","['Fifty sound extracted premolars', 'artificial white-spot lesions']","['resin infiltration and 5,000 cycles of thermocycling; Group 5: AWL treated with resin infiltration and 10,000 cycles of thermocycling']",[],"[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]",[],50.0,0.0157046,"No microleakage was seen in Group 3, and differences between Groups 3, 4, and 5 were not significant (P > 0.05).","[{'ForeName': 'Awiruth', 'Initials': 'A', 'LastName': 'Klaisiri', 'Affiliation': 'Division of Operative Dentistry, Faculty of Dentistry, Thammasat University.'}, {'ForeName': 'Suksantiphop', 'Initials': 'S', 'LastName': 'Janchum', 'Affiliation': 'School of Dentistry, Mae Fah Luang University.'}, {'ForeName': 'Kunyakorn', 'Initials': 'K', 'LastName': 'Wongsomtakoon', 'Affiliation': 'Dental department of Buayai hospital.'}, {'ForeName': 'Panukorn', 'Initials': 'P', 'LastName': 'Sirimanathon', 'Affiliation': 'Dental department of Pabon hospital.'}, {'ForeName': 'Nantawan', 'Initials': 'N', 'LastName': 'Krajangta', 'Affiliation': 'Division of Operative Dentistry, Faculty of Dentistry, Thammasat University.'}]",Journal of oral science,['10.2334/josnusd.19-0321']
2053,32830200,Bacterial lipopolysaccharide as negative predictor of gemcitabine efficacy in advanced pancreatic cancer - translational results from the AIO-PK0104 Phase 3 study.,"BACKGROUND


Gram-negative bacteria mediated gemcitabine resistance in pre-clinical models. We determined if intratumoural lipopolysaccharide (LPS) detection by immunohistochemistry is associated with outcome in advanced pancreatic ductal adenocarcinoma (PDAC) treated with gemcitabine and non-gemcitabine containing 1st-line chemotherapy.
METHODS


We examined LPS on tumour tissue from 130 patients treated within the randomised AIO-PK0104 trial and a validation cohort (n = 113) and analysed the association of LPS detection to patient outcome according to treatment subgroups.
RESULTS


In 24% of samples from the AIO-PK0104 study LPS was detected; in LPS-positive patients median OS was 4.4 months, compared to 7.3 months with LPS negative tumours (HR 1.732, p = 0.010). A difference in OS was detected in 1st-line gemcitabine-treated patients (n = 71; HR 2.377, p = 0.002), but not in the non-gemcitabine treatment subgroup (n = 59; HR 1.275, p = 0.478). Within the validation cohort, the LPS positivity rate was 23%, and LPS detection was correlated with impaired OS in the gemcitabine subgroup (n = 94; HR 1.993, p = 0.008) whereas no difference in OS was observed in the non-gemcitabine subgroup (n = 19; HR 2.596, p = 0.219).
CONCLUSIONS


The detection of intratumoural LPS as surrogate marker for gram-negative bacterial colonisation may serve as a negative predictor for gemcitabine efficacy in advanced PDAC.
CLINICAL TRIAL REGISTRY


The Clinical trial registry identifier is NCT00440167.",2020,"A difference in OS was detected in 1st-line gemcitabine-treated patients (n = 71; HR 2.377, p = 0.002), but not in the non-gemcitabine treatment subgroup (n = 59; HR 1.275, p = 0.478).","['advanced pancreatic ductal adenocarcinoma (PDAC) treated with', '130 patients treated within the randomised AIO-PK0104 trial and a validation cohort (n\u2009=\u2009113']","['gemcitabine', 'Bacterial lipopolysaccharide', 'gemcitabine and non-gemcitabine', 'LPS']","['LPS positivity rate', 'OS', 'LPS detection']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",130.0,0.0321348,"A difference in OS was detected in 1st-line gemcitabine-treated patients (n = 71; HR 2.377, p = 0.002), but not in the non-gemcitabine treatment subgroup (n = 59; HR 1.275, p = 0.478).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Guenther', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kruger', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Christoph Benedikt', 'Initials': 'CB', 'LastName': 'Westphalen', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'von Bergwelt-Baildon', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Department of Internal Medicine II, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirchner', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Boeck', 'Affiliation': 'Department of Internal Medicine III, Grosshadern University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Ormanns', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University, Munich, Germany. steffen.ormanns@med.uni-muenchen.de.'}]",British journal of cancer,['10.1038/s41416-020-01029-7']
2054,32830326,Attrition and attendance in group therapy for university students: An examination of predictors across time.,"OBJECTIVES


There exists a dearth of research focused explicitly on predictors of attrition, particularly in the area of group therapy, where both attrition and attendance becomes of primary concern. The present study examined both pretreatment and treatment-specific variables in the prospective prediction of attendance and attrition in group therapy.
METHOD


Fifty-two participants were randomized to one of two 12-week group treatments. Participants completed baseline interviews and questionnaires, as well as weekly assessments of treatment-specific factors.
RESULTS


No pretreatment factors predicted attendance or drop out, although men attended a larger amount of sessions and were less likely to drop out. Cross-lagged panel analyses supported bidirectional, causal relationships both treatment-specific predictors (therapeutic alliance and number of therapeutic techniques) and attendance.
CONCLUSIONS


Successful retention in group therapy may be less predictable from pretreatment factors and instead lie in increasing alliance and fostering the practice of therapeutic strategies.",2020,"No pretreatment factors predicted attendance or drop out, although men attended a larger amount of sessions and were less likely to drop out.","['Fifty-two participants', 'university students']",[],['Attrition and attendance'],"[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",52.0,0.0185663,"No pretreatment factors predicted attendance or drop out, although men attended a larger amount of sessions and were less likely to drop out.","[{'ForeName': 'Tahira', 'Initials': 'T', 'LastName': 'Gulamani', 'Affiliation': 'Department of Psychological Clinical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Amanda A', 'Initials': 'AA', 'LastName': 'Uliaszek', 'Affiliation': 'Department of Psychological Clinical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Chugani', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Tayyab', 'Initials': 'T', 'LastName': 'Rashid', 'Affiliation': 'The Health and Wellness Centre, University of Toronto Scarborough, Toronto, Ontario, Canada.'}]",Journal of clinical psychology,['10.1002/jclp.23042']
2055,32830332,The therapeutic effects and safety of bright light therapy combined with escitalopram oxalate on insomnia in patients with poststroke depression.,"INTRODUCTION


Bright light therapy (BLT) is known to treat depression and sleep disorders in clinical practice, but its efficacy on poststroke depression (PSD) has not been studied.
OBJECTIVE


To investigate the therapeutic effects and safety of BLT combined with escitalopram oxalate (ESC) on insomnia in patients with poststroke depression.
METHODS


Ischemic stroke patients with depressive symptoms and a score of ≥ 8 on the Hamilton Depression Scale (HAMD-17) while meeting DSM-IV criteria were diagnosed as having PSD. A total of 112 PSD patients with symptoms of insomnia were randomly assigned to polytherapy (BLT plus ESC) and monotherapy (ESC only) groups. Each regimen continued for six weeks. The primary outcomes were a change in scores on the Pittsburgh Sleep Quality Index (PSQI) and a remission rate (PSQI ≤ 7 at the endpoint). The secondary outcomes included changes in the HAMD-17 and Barthel Index (BI) scores. Adverse effects were assessed by the Adverse Events Scale.
RESULTS


The endpoint assessment included 106 patients (monotherapy, 54; polytherapy, 52). The mean changes in the PSQI scores for the monotherapy and polytherapy groups were 4.85 (1.47) and 5.87 (1.72) (P = 0.001), respectively. Compared to monotherapy, polytherapy improved PSQI remission rate (71.4% vs 50.0%; χ2 = 5.390; P = 0.020), and HAMD-17 score (6.70 [2.12] vs 4.75 [1.98]; P < 0.001). Both treatments improved BI score, with no statistical difference, and were well-tolerated, with few significant differences in treatment-associated adverse events.
CONCLUSION


BLT combined with ESC is effective and well-tolerated for the treatment of PSD-associated insomnia. This article is protected by copyright. All rights reserved.",2020,"Both treatments improved BI score, with no statistical difference, and were well-tolerated, with few significant differences in treatment-associated adverse events.
","['Ischemic stroke patients with depressive symptoms and a score of ≥\u20098 on the Hamilton Depression Scale (HAMD-17) while meeting DSM-IV criteria were diagnosed as having PSD', '106 patients (monotherapy, 54; polytherapy, 52', '112 PSD patients with symptoms of insomnia', 'patients with poststroke depression']","['bright light therapy combined with escitalopram oxalate', 'polytherapy (BLT plus ESC) and monotherapy (ESC', 'BLT combined with ESC', 'BLT combined with escitalopram oxalate (ESC', 'Bright light therapy (BLT']","['effective and well-tolerated', 'BI score', 'changes in the HAMD-17 and Barthel Index (BI) scores', 'change in scores on the Pittsburgh Sleep Quality Index (PSQI) and a remission rate (PSQI ≤\u20097 at the endpoint', 'HAMD-17 score', 'PSQI scores', 'Adverse effects', 'PSQI remission rate']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",112.0,0.0682695,"Both treatments improved BI score, with no statistical difference, and were well-tolerated, with few significant differences in treatment-associated adverse events.
","[{'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Qiongzhang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Luan', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Siyan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Jincai', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}]",International journal of geriatric psychiatry,['10.1002/gps.5412']
2056,32830368,"Time-varying Effects of 'Optimized Smoking Treatment' on Craving, Negative Affect, and Anhedonia.","AIMS


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


Secondary analysis of data from a 2-arm randomized controlled trial.
SETTING


Seven primary care clinics in Wisconsin, USA.
PARTICIPANTS


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


Intervention was Abstinence-Optimized Treatment (A-OT, n=276) comprising 3 weeks of nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD, and extensive psychosocial support. Comparator was Recommended Usual Care (RUC, n=298) comprising brief counseling and 8 weeks of nicotine patch post-TQD.
MEASUREMENTS


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


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


Time-varying effect models showed that a multicomponent treatment intervention for smoking cessation suppressed significant withdrawal symptoms better than recommended usual care among daily adult smokers motivated to quit. The intervention reduced craving pre- and post-target quit day (TQD) and anhedonia post-TQD.",2020,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","['Seven primary care clinics in Wisconsin, USA', 'Adult primary care patients who smoked daily (N=574']","['nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD, and extensive psychosocial support', 'nicotine patch post-TQD']","['post-TQD anhedonia', 'nightly cigarette craving, negative affect, and anhedonia', 'post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence', 'Craving, Negative Affect, and Anhedonia', 'Greater post-TQD craving', 'anhedonia', 'Time-varying effect models examined dynamic effects of A-OT (versus RUC', 'pre- and post-TQD craving', 'RUC', 'craving pre- and post-target quit day (TQD) and anhedonia post-TQD', 'greater craving', 'lower anhedonia', 'withdrawal symptoms']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}]",,0.0239201,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, 53711, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, 53711, USA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, 53711, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, 53711, USA.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, 53711, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, 53711, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15232']
2057,32830383,Skin Cleaning among Hospitalized Persons Who Inject Drugs: A randomized controlled trial.,"AIMS


To test the hypothesis that among hospitalized people who inject drugs (PWID), a brief intervention in skin-cleaning would result in greater reductions in follow-up emergency department (ED) or hospitalization rates compared with a usual care condition.
DESIGN


Randomized, two group (intervention. n=128; usual care, n=124), single site clinical trial with12-month follow-up.
SETTING


Hospital inpatient services in Boston, Massachusetts, USA.
PARTICIPANTS


Persons who injected drugs on at least 3 days each week prior to hospital admission (n=252). Participants averaged 37.9 (± 10.7) years of age, 58.5% were male, 59.3% were white, and 61.1% had a diagnosis related to skin infection at enrollment.
INTERVENTION AND COMPARATOR


Intervention was a skin hygiene education and skills-training behavioral intervention (SKIN) consisting of two education and skills-based skin-cleaning sessions, one during hospitalization and another 4 weeks later. Comparator was treatment as usual: an informational brochure about substance use treatment options and needle exchange programs in the area, and follow-up clinical appointments as arranged by the inpatient medical staff.
MEASUREMENTS


Electronic medical records were reviewed and discharge diagnoses for each ED visit and hospital admission were categorized into injection-related bacterial events (e.g., cellulitis) and non-injection-related events. Negative binomial regression was used to test the intervention effects for the primary outcome, total ED visits, as well as the secondary outcomes, total number of hospitalizations, injection drug use related (IDU-related) ED visits, and IDU-related hospitalizations. We also tested whether the outcomes were moderated by whether the initial hospitalization was IDU-related.
FINDINGS


Of persons assigned to SKIN, 66 completed two sessions, 55 completed one session and seven completed zero sessions. Adjusting for baseline covariates, the mean rate of total ED visits in the next 12 months was non-significantly higher (IRR = 1.13; 95%CI 0.96; 1.33, p = .152) compared with usual treatment. The intervention did not significantly reduce total hospitalizations or IDU-related hospitalisations. Adjusting for baseline covariates, the mean rate of injection drug use related ED visits in the next 12 months was lower (IRR = 0.58; 95%CI 0.37; 0.92, p = .019) compared with treatment as usual.
CONCLUSIONS


A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization. There was some evidence that it may have reduced injection drug use related emergency department visits.",2020,"CONCLUSIONS


A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization.","['n=128; usual care, n=124), single site clinical trial with12-month follow-up', 'hospitalized people who inject drugs (PWID', 'Hospitalized Persons', 'Hospital inpatient services in Boston, Massachusetts, USA.\nPARTICIPANTS\n\n\nPersons who injected drugs on at least 3 days each week prior to hospital admission (n=252', 'Participants averaged 37.9 (± 10.7) years of age, 58.5% were male, 59.3% were white, and 61.1% had a diagnosis related to skin infection at enrollment']","['Inject Drugs', 'Skin Cleaning', 'SKIN', 'skin hygiene education and skills-training behavioral intervention (SKIN) consisting of two education and skills-based skin-cleaning sessions', 'skin-cleaning intervention', 'informational brochure about substance use treatment options and needle exchange programs']","['discharge diagnoses for each ED visit and hospital admission were categorized into injection-related bacterial events (e.g., cellulitis) and non-injection-related events', 'total hospitalizations or IDU-related hospitalisations', 'mean rate of total ED visits', 'mean rate of injection drug use related ED visits', 'total ED visits, as well as the secondary outcomes, total number of hospitalizations, injection drug use related (IDU-related) ED visits, and IDU-related hospitalizations', 'overall emergency department use or hospitalization']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1286234', 'cui_str': 'Skin hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0574729', 'cui_str': 'Skin clean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0242883', 'cui_str': 'Syringe-Exchange Programs'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0020811', 'cui_str': 'Idoxuridine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.061035,"CONCLUSIONS


A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, 02906, USA.'}, {'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Phillips', 'Affiliation': 'Center for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI, 96817, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Herman', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, 02906, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Keosaian', 'Affiliation': 'Boston University School of Public Health, Boston, MA, 02118, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Boston University School of Public Health, Boston, MA, 02118, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, 02906, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Weinstein', 'Affiliation': 'Boston University School of Medicine, Section of General Internal Medicine, Boston, MA, 02118, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Liebschutz', 'Affiliation': 'Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh, Pittsburgh, PA, 15213, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15236']
2058,32830416,Effect of polyethylene cover on the treatment of exposure keratopathy in ICU.,"BACKGROUND


Exposure keratopathy may lead to serious complications such as microbial keratitis, corneal perforation, and visual impairment if not treated.
AIM


To compare the effect of carbomer eye drops when used alone and in combination with polyethylene covers in the healing of exposure keratopathy.
METHODS


A single blind randomized-controlled trial (RCT) in two intensive care units (ICUs) was carried out in a university hospital in Western Turkey between September 2011 and December 2012. The control group received only carbomer, eye drops while the intervention group received both carbomer eye drops and polyethylene covers. The primary outcome was the decrease or absence of corneal damage, which refers to healing. Corneal damage was followed up with a fluorescein dye test (decrease/absence of the corneal staining) by the same ophthalmologist for 10 days.
RESULTS


A total of 43 corneas in 24 patients were studied. Corneal epithelial defects decreased in the intervention group by day 2 and progressed or remained unchanged in the control group every day (P = .001). Patient characteristics did not affect the grade ranges of corneal staining in the groups except for level of consciousness.
CONCLUSION


Carbomer eye drops, when used in combination with polyethylene covers, were effective in managing exposure keratopathy.
RELEVANCE TO CLINICAL PRACTICE


Corneal damage and further ocular complications can be reduced with the utilization of polyethylene covers in nursing care and treatment.",2020,Corneal epithelial defects decreased in the intervention group by day 2 and progressed or remained unchanged in the control group every day (P = .001).,"['two intensive care units (ICUs) was carried out in a university hospital in Western Turkey between September 2011 and December 2012', 'A total of 43 corneas in 24 patients were studied', 'exposure keratopathy in ICU']","['carbomer eye drops', 'only carbomer, eye drops while the intervention group received both carbomer eye drops and polyethylene covers', 'polyethylene']","['Corneal damage', 'decrease or absence of corneal damage, which refers to healing', 'Corneal epithelial defects', 'grade ranges of corneal staining']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0339295', 'cui_str': 'Exposure keratoconjunctivitis'}]","[{'cui': 'C0770624', 'cui_str': 'Carbomer'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0339289', 'cui_str': 'Injury of cornea'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1299691', 'cui_str': 'Corneal epithelial defect'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}]",24.0,0.0716824,Corneal epithelial defects decreased in the intervention group by day 2 and progressed or remained unchanged in the control group every day (P = .001).,"[{'ForeName': 'Elem', 'Initials': 'E', 'LastName': 'Kocaçal', 'Affiliation': 'Department of Fundamentals of Nursing, İzmir Demokrasi University, Faculty of Health Sciences, İzmir, Turkey.'}, {'ForeName': 'İsmet', 'Initials': 'İ', 'LastName': 'Eşer', 'Affiliation': 'Department of Fundamentals of Nursing, Ege University Faculty of Nursing, İzmir, Turkey.'}, {'ForeName': 'Sait', 'Initials': 'S', 'LastName': 'Eğrilmez', 'Affiliation': 'Department of Ophthalmology, Ege University Medical Hospital, İzmir, Turkey.'}]",Nursing in critical care,['10.1111/nicc.12542']
2059,32830436,Different Surgical Strategy for Patients with Cervical Angina: A Potential Role of Luschka's Joint Osteophyte.,"OBJECTIVE


Cervical angina is an underrecognized type of noncardiac chest pain and its mechanism of pain remains obscure. The objective of the current study was to investigate the clinical outcomes of different surgical strategies for patients with cervical angina and to analyze the potential pathogenesis of Luschka's joint osteophyte.
METHODS


From February 2013 to March 2018, a prospective study on cervical angina was performed in our hospital. All patients who were diagnosed with both noncardiac chest pain and cervical pathology were identified. During admission, they consulted with a cardiologist and underwent strict cardiac workups to exclude true angina pectoris. The included 41 patients were randomly divided into two groups according to different surgical strategies of whether or not to remove Luschka's joint osteophyte during anterior cervical decompression surgery: the osteophyte resection (OR group) and the nonresection (NR group).
RESULTS


The OR group consisted of 21 patients (8 men and 13 women) with a mean age of 54.7 years (range, 41-65 years). The NR group was composed of 20 patients (9 men and 11 women) with an average age of 56.3 years (range, 43-68 years). Before surgery, the mean duration of symptoms was 6.1 months (range, 4-20 months). The Luschka's joint osteophytes were located at C 6  -C 7  (19 cases, 46.3%), C 5  -C 6  (17 cases, 41.5%), and C 4  -C 5  (4 cases, 12.2%). Their average area was 34.85 mm 2  and the average length were 5.09 mm. No statistically significant differences in demographic characteristics were detected between the two groups (P > 0.05). After operation, there were significant improvements in the Japanese Orthopedic Association score and the Neck Disability Index score in both groups (P < 0.05). However, the visual analogue scale score for chest pain in the OR group was statistically lower than that in the NR group (1.4 ± 1.0 vs 2.1 ± 1.6, P < 0.05). In the OR group, the results of cervical spine surgery were excellent in 18 patients (85.7%), and fair in 3 patients (14.3%). In the NR group, there were 10 patients (50.0%) with excellent results, 9 patients with fair results (45.0%), and 1 patient with poor results (5.0%). Notably, there were statistically significant differences between the two groups (χ 2  = 6.265, P = 0.044). The average follow-up was 31 months (24-52 months).
CONCLUSION


Anterior cervical decompression surgery with resection of Luschka's joint osteophyte can effectively reduce cervical angina symptom and improve the patient's quality of life. In addition to nerve root compression, Luschka's joint osteophyte may be another pathogenic factor in cervical angina.",2020,"However, the visual analogue scale score for chest pain in the OR group was statistically lower than that in the NR group (1.4 ± 1.0 vs 2.1 ± 1.6, P < 0.05).","['Patients with Cervical Angina', 'From February 2013 to March 2018, a prospective study on cervical angina was performed in our hospital', '21 patients (8 men and 13 women) with a mean age of 54.7\u2009years (range, 41-65\u2009years', ""patients with cervical angina and to analyze the potential pathogenesis of Luschka's joint osteophyte"", '20 patients (9 men and 11 women) with an average age of 56.3\u2009years (range, 43-68\u2009years', '41 patients', 'All patients who were diagnosed with both noncardiac chest pain and cervical pathology']","[""Luschka's joint osteophyte during anterior cervical decompression surgery: the osteophyte resection (OR group) and the nonresection (NR group""]","['cervical angina symptom', 'Japanese Orthopedic Association score and the Neck Disability Index score', 'cervical spine surgery', 'mean duration of symptoms', 'visual analogue scale score for chest pain', ""Luschka's joint osteophytes"", 'demographic characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0543483', 'cui_str': 'pathogenesis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",41.0,0.0170172,"However, the visual analogue scale score for chest pain in the OR group was statistically lower than that in the NR group (1.4 ± 1.0 vs 2.1 ± 1.6, P < 0.05).","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': 'Department of Spine Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiu-Yuan', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Spine Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Li-Feng', 'Initials': 'LF', 'LastName': 'Lao', 'Affiliation': 'Department of Spine Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Shen', 'Affiliation': 'Department of Spine Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Orthopaedic surgery,['10.1111/os.12751']
2060,32830463,Kinetic-Pharmacodynamic Model of Platelet Time Course in Patients With Moderate-to-Severe Atopic Dermatitis Treated With Oral Janus Kinase 1 Inhibitor Abrocitinib.,"The oral Janus kinase 1 (JAK1) inhibitor abrocitinib reduced signs and symptoms of atopic dermatitis (AD) in a placebo-controlled, randomized, double-blind, phase 2b trial (dose range, 10 mg-200 mg). A kinetic-pharmacodynamic (K-PD) model consisting of proliferation, maturation, and blood circulation compartments was developed to characterize platelet count changes during the study. The K-PD model consisted of a drug elimination constant, 4 system parameters describing platelet dynamics, variance terms, correlation, and residual errors. Overall, these patients exhibited mean transit time from progenitor cells to platelets of 8.2 days (longer than the reported megakaryocyte life span), likely arising from JAK1-induced perturbations of platelet progenitor homeostasis. The final model described dose-related platelet count declines until nadir at treatment week 4 and return to baseline levels thereafter. The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.",2020,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,['Patients With Moderate-to-Severe Atopic Dermatitis'],[],['mean transit time'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.114435,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Pfizer Inc., Sandwich, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Peterson', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12548']
2061,32830462,Effect of vitamin D supplementation on N-glycan branching and cellular immunophenotypes in MS.,"OBJECTIVE


To investigate the effect of cholecalciferol (vitamin D3) supplementation on peripheral immune cell frequency and N-glycan branching in patients with relapsing-remitting multiple sclerosis (RRMS).
METHODS


Exploratory analysis of high-dose (20 400 IU) and low-dose (400 IU) vitamin D3 supplementation taken every other day of an 18-month randomized controlled clinical trial including 38 RRMS patients on stable immunomodulatory therapy (NCT01440062). We investigated cholecalciferol treatment effects on N-glycan branching using L-PHA stain (phaseolus vulgaris leukoagglutinin) at 6 months and frequencies of T-, B-, and NK-cell subpopulations at 12 months with flow cytometry.
RESULTS


High-dose supplementation did not change CD3+ T cell subsets, CD19+ B cells subsets, and NK cells frequencies, except for CD8+ T regulatory cells, which were reduced in the low-dose arm compared to the high-dose arm at 12 months. High-dose supplementation decreased N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI). A reduction of N-glycan branching in B cells was not significant. In contrast, low-dose supplementation did not affect N-glycan branching. Changes in N-glycan branching did not correlate with cell frequencies.
INTERPRETATION


Immunomodulatory effect of vitamin D may involve regulation of N-glycan branching in vivo. Vitamin D3 supplementation did at large not affect the frequencies of peripheral immune cells.",2020,"High-dose supplementation decreased N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI).","['38 RRMS patients on stable immunomodulatory therapy (NCT01440062', 'patients with relapsing-remitting multiple sclerosis (RRMS']","['vitamin D supplementation', 'vitamin D', 'cholecalciferol (vitamin D3) supplementation', 'cholecalciferol', 'low-dose (400\xa0IU) vitamin D3 supplementation', 'Vitamin D3 supplementation']","['frequencies of peripheral immune cells', 'peripheral immune cell frequency and N-glycan branching', 'N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI', 'change CD3+\xa0T cell subsets, CD19+ B cells subsets, and NK cells frequencies, except for CD8+\xa0T regulatory cells']","[{'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1963758', 'cui_str': 'Immunomodulatory therapy'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030779', 'cui_str': 'Pelger-Huët anomaly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0079004', 'cui_str': 'B-Cell Subsets'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}]",38.0,0.136472,"High-dose supplementation decreased N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI).","[{'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Bäcker-Koduah', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Infante-Duarte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Institute for Medical Immunology, Berlin, Germany.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ivaldi', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, CEBR University of Genoa, Genoa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Uccelli', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, CEBR University of Genoa, Genoa, Italy.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bellmann-Strobl', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Klaus-Dieter', 'Initials': 'KD', 'LastName': 'Wernecke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sy', 'Affiliation': 'Department of Neurology, University of California, Irvine, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Demetriou', 'Affiliation': 'Department of Neurology, University of California, Irvine, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dörr', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ulrich Brandt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51148']
2062,32830514,Chondral Defects Cause Kissing Lesions in a Porcine Model.,"OBJECTIVE


To assess the development of kissing lesions 12 months after the generation of full-thickness chondral defects.
DESIGN


Eight minipigs were randomized into 2 groups: the Φ8.5 mm full-thickness chondral defect group (8.5FT group) and the Φ6.5 mm full-thickness chondral defect group (6.5FT group). The Φ8.5 mm or Φ6.5 mm full-thickness chondral defects were prepared in the medial femoral condyle. Knee magnetic resonance imaging (MRI) was performed before sacrifice. India ink staining was performed to macroscopically assess kissing lesions. Histologic staining (hematoxylin-eosin [HE], safranin O/fast green, toluidine blue staining) and immunohistochemistry (collagen I, collagen II, collagen X, MMP-3) were performed. Microcomputed tomography analysis was completed to assess subchondral bone alterations.
RESULTS


Obvious kissing lesions were observed on the tibial plateau. Knee MRI demonstrated high cartilage signal intensity in the medial femoral condyle and opposite tibial plateau. HE staining demonstrated cartilage fibrillation and prominent cell death. The depletion of safranin O, toluidine blue staining, and collagen II was observed in the kissing lesion areas. The kissing lesion areas demonstrated increased collagen I, Collagen X, and MMP-3 expression. The 8.5FT group showed a significantly lower mean trabecular number (2.80 1/mm) than the control group (3.26 1/mm). The 6.5FT group showed a significantly increased mean trabecular thickness (0.54 mm) and a decreased mean trabecular number (2.71 1/mm) compared to the control group (0.32 mm; 3.26 1/mm).
CONCLUSIONS


Obvious kissing lesions were observed on the tibial plateau. Knee MRI demonstrated high cartilage signal The presented findings support the development of kissing lesions caused by full-thickness chondral defects.",2020,"The depletion of safranin O, toluidine blue staining, and collagen II was observed in the kissing lesion areas.",['Eight minipigs'],"['Knee magnetic resonance imaging (MRI', 'Φ8.5 mm full-thickness chondral defect group (8.5FT group) and the Φ6.5 mm full-thickness chondral defect group (6.5FT group']","['mean trabecular number', 'cartilage signal intensity', 'collagen', 'depletion of safranin O, toluidine blue staining, and collagen II', 'Histologic staining (hematoxylin-eosin [HE], safranin O/fast green, toluidine blue staining) and immunohistochemistry (collagen I, collagen II, collagen X, MMP-3', 'cartilage fibrillation and prominent cell death', 'mean trabecular thickness']","[{'cui': 'C0039011', 'cui_str': 'Miniature Swine'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C3844007', 'cui_str': '6.5'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0073949', 'cui_str': 'Safranin stain'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0018964', 'cui_str': 'Hematoxylin stain'}, {'cui': 'C0014448', 'cui_str': 'Eosine Yellowish'}, {'cui': 'C0060086', 'cui_str': 'Fast Green'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0232197', 'cui_str': 'Fibrillation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",8.0,0.0214159,"The depletion of safranin O, toluidine blue staining, and collagen II was observed in the kissing lesion areas.","[{'ForeName': 'Wenqiang', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ziying', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zhongyang', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Dongquan', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}]",Cartilage,['10.1177/1947603520951636']
2063,32830524,A New Medical Device for Improved Rotation of Insulin Injections in Type 1 Diabetes Mellitus: A Proof-of-Concept Study.,"INTRODUCTION


Lipohypertrophy (LH) is caused by repetitively injecting insulin into the same location. This can lead to unpredictable insulin absorption and increased glucose variability (GV). A new medical device, ROTO Track, automatically guides the user to rotate abdominal insulin injections to avoid LH lesions. This study aimed to test whether the medical device could reduce the number of insulin injections in the same subcutaneous area as compared with non-aided standard insulin injection techniques.
METHODS


In this proof-of-concept cross-over study, baseline data about injection site in the abdominal region were collected blinded for 1 week with a nonguiding version of the device and compared to 1 and 12 weeks of device guidance in 35 people with type 1 diabetes. The device registered time and location of abdominal injections. The primary endpoint was a ""rotation score."" Secondary endpoints included number and size of LH, GV, and hemoglobin A1c.
RESULTS


The rotation score improved significantly from a baseline mean of 40.2% to 49.9% after 1 week (confidence interval: 2.2-17.2%,  P  = .012) and improved further after 12 weeks to 52.2% ( P  < .001). After 12 weeks, LH was reduced both in median size from 9.2 (range: [0.9-29.4]) cm 2  to 5.4 (range: [0.0- 26.8]) cm 2  ( P  = .041) and mean count from 1.4 (range: [1-2]) to 1.1 (range: [0-2],  P  = .039) and the coefficient of variation of interstitial glucose was reduced from 38.6 to 35.1 ( P  = .009).
CONCLUSION


This proof-of-concept study indicates that the device improves rotation of insulin injections, and reduces LH and GV.",2020,"The rotation score improved significantly from a baseline mean of 40.2% to 49.9% after 1 week (confidence interval: 2.2-17.2%,  P  = .012) and improved further after 12 weeks to 52.2% ( P  < .001).","['Type 1 Diabetes Mellitus', '35 people with type 1 diabetes']",['Lipohypertrophy (LH'],"['glucose variability (GV', 'number and size of LH, GV, and hemoglobin A1c', 'number of insulin injections', 'coefficient of variation of interstitial glucose', 'rotation score', 'LH']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1262113', 'cui_str': 'Lipohypertrophy'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1262113', 'cui_str': 'Lipohypertrophy'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",35.0,0.130422,"The rotation score improved significantly from a baseline mean of 40.2% to 49.9% after 1 week (confidence interval: 2.2-17.2%,  P  = .012) and improved further after 12 weeks to 52.2% ( P  < .001).","[{'ForeName': 'Carina Kirstine', 'Initials': 'CK', 'LastName': 'Klarskov', 'Affiliation': 'Department of Endocrinology and Nephrology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Yasmin Hassan', 'Initials': 'YH', 'LastName': 'Hamid', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Tjalk-Bøggild', 'Affiliation': 'Nordic Healthcare Technology, Birkerød, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Steno Diabetes Center Sjælland, Denmark.'}, {'ForeName': 'Peter Lommer', 'Initials': 'PL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Endocrinology and Nephrology, Nordsjællands Hospital, Hillerød, Denmark.'}]",Journal of diabetes science and technology,['10.1177/1932296820950688']
2064,32830532,"ELFIN, the United Kingdom preterm lactoferrin trial: interpretation and future questions.","Previous studies suggested that supplemental bovine lactoferrin (BLF) given to preterm infants (<32 weeks gestation) may reduce late onset sepsis (LOS) and necrotising enterocolitis (NEC), but have been underpowered. The Enteral Lactoferrin in Neonates (ELFIN) study, performed in the United Kingdom (UK), aimed to further address this issue with a well powered double blinded placebo controlled trial of >2200 preterm infants. ELFIN did not demonstrate a reduction in LOS or NEC, or several other clinically important measures. 316 (29%) of 1093 infants in the intervention group developed late-onset sepsis versus 334 (31%) of 1089 in the control group with an adjusted risk ratio of 0·95 (95% CI 0·86-1·04; p=0· 233). Reasons for the differences in ELFIN trial results and other studies may include population differences, the routine use of antifungals in the UK, timing of administration of the lactoferrin in relation to disease onset, or specific properties of the lactoferrin used in different trials. Further exploration is being undertaken in the UK NIHR funded Mechanisms Affecting the Guts of Preterm Infants in Enteral feeding trials (MAGPIE) study, for which results should be available soon.",2020,"ELFIN did not demonstrate a reduction in LOS or NEC, or several other clinically important measures.","['2200 preterm infants', 'Neonates (ELFIN) study, performed in the United Kingdom (UK']","['supplemental bovine lactoferrin (BLF', 'placebo', 'ELFIN', 'Enteral Lactoferrin']","['late-onset sepsis', 'late onset sepsis (LOS) and necrotising enterocolitis (NEC']","[{'cui': 'C4517651', 'cui_str': '2200'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]",2200.0,0.309879,"ELFIN did not demonstrate a reduction in LOS or NEC, or several other clinically important measures.","[{'ForeName': 'Janet Elizabeth', 'Initials': 'JE', 'LastName': 'Berrington', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, 5983, Neonatology , Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland , NE7 7DN.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuire', 'Affiliation': 'University of York, 8748, Centre for reviews and dissemination , York, North Yorkshire, United Kingdom of Great Britain and Northern Ireland ; william.mcguire@york.ac.uk.'}, {'ForeName': 'NIcholas David', 'Initials': 'ND', 'LastName': 'Embleton', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, 5983, Neonatology , Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland.'}]",Biochemistry and cell biology = Biochimie et biologie cellulaire,['10.1139/bcb-2020-0073']
2065,32830552,Elevated plasma lactate levels via exogenous lactate infusion do not alter resistance exercise-induced signaling or protein synthesis in human skeletal muscle.,"Lactate has been implicated as a potential signaling molecule. In myotubes, lactate incubation increases mTORC1- and ERK-signaling and induces hypertrophy, indicating that lactate could be a mediator of muscle adaptations to resistance exercise. However, the potential signaling properties of lactate, at rest or with exercise, have not been explored in human tissue. In a cross-over design study, 8 men and 8 women performed one-legged resistance exercise while receiving venous infusion of saline or sodium lactate. Blood was sampled repeatedly, and muscle biopsies were collected at rest and at 0, 90,180 min and 24 h after exercise. The primary outcomes examined were intracellular signaling, fractional protein synthesis rate (FSR), and blood/muscle levels of lactate and pH. Post-exercise blood lactate concentrations were 130% higher in the Lactate trial (3.0 vs 7.0 mmol×l -1 ,  p<0.001) whereas muscle levels were only marginally higher (27 vs 32 mmol×kg -1  d.w., p=0.003) compared to the Saline-trial. Post-exercise blood pH was higher in the Lactate-trial (7.34 vs 7.44, p<0.001), with no differences in intramuscular pH. Exercise increased the phosphorylation of mTOR S2448  (~40%), S6K1 T389  (~3-fold), and p44 T202/T204  (~80%) during recovery, without any differences between trials. FSR over the 24-h recovery period did not differ between the Saline (0.067 %/h) and Lactate (0.062 %/h) trials. This study does not support the hypothesis that blood lactate levels can modulate anabolic signaling in contracted human muscle. Further in vivo research investigating the impact of exercised versus rested muscle and the role of intramuscular lactate is needed to elucidate its potential signaling properties.",2020,"Post-exercise blood pH was higher in the Lactate-trial (7.34 vs 7.44, p<0.001), with no differences in intramuscular pH. Exercise increased the phosphorylation of mTOR S2448  (~40%), S6K1 T389  (~3-fold), and p44 T202/T204  (~80%) during recovery, without any differences between trials.",['8 men and 8 women performed one'],['legged resistance exercise while receiving venous infusion of saline or sodium lactate'],"['Post-exercise blood pH', 'FSR', 'intracellular signaling, fractional protein synthesis rate (FSR), and blood/muscle levels of lactate and pH. Post-exercise blood lactate concentrations', 'muscle levels', 'phosphorylation of mTOR S2448']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0142874', 'cui_str': 'Sodium lactate'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}]",8.0,0.0586339,"Post-exercise blood pH was higher in the Lactate-trial (7.34 vs 7.44, p<0.001), with no differences in intramuscular pH. Exercise increased the phosphorylation of mTOR S2448  (~40%), S6K1 T389  (~3-fold), and p44 T202/T204  (~80%) during recovery, without any differences between trials.","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Liegnell', 'Affiliation': 'Åstrand Laboratory, Swedish School of Sport and Health Sciences, Sweden.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Apró', 'Affiliation': 'Åstrand Laboratory, Swedish School of Sport and Health Sciences, Karolinska Institutet, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Danielsson', 'Affiliation': 'Åstrand Laboratory, Swedish School of Sport and Health Sciences, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ekblom', 'Affiliation': 'Astrand Laboratory, Swedish School of Sport and Health Sciences, Sweden.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'University of Copenhagen.'}, {'ForeName': 'Hans-Christer', 'Initials': 'HC', 'LastName': 'Holmberg', 'Affiliation': 'Department of Health Sciences, Swedish Winter Sports Research Centre, Mid Sweden University, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Åstrand Laboratory, Swedish School of Sport and Health Sciences, Sweden.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00291.2020']
2066,32830553,Hyperglycemia does not Inhibit Insulin's Effects on Microvascular Perfusion in Healthy Humans: A Randomized Crossover Study.,"Diabetes mellitus accelerates vascular disease through multiple biochemical pathways driven by hyperglycemia, with insulin resistance and/or hyperinsulinemia also contributing. Persons with diabetes mellitus experience premature large vessel and microvascular disease when compared to normoglycemic controls. Currently there is a paucity of clinical data identifying how acutely the vasculature responds to hyperglycemia and whether other physiologic factors (e.g., vasoactive hormones) contribute. To our knowledge, no prior studies have examined the dynamic effects of acute hyperglycemia on insulin-mediated actions on both micro- and macrovascular function in the same subjects. In this randomized crossover trial, healthy young adults underwent two infusion protocols designed to compare the effects of insulin infusion during euglycemia and hyperglycemia on micro- and macrovascular function. Both euglycemic- and hyperglycemic-hyperinsulinemia increased skeletal (but not cardiac) muscle microvascular blood volume (each p<0.02) and blood flow significantly (each p<0.04), and these increases did not differ between protocols. Hyperglycemic-hyperinsulinemia trended towards increased carotid-femoral pulse wave velocity (indicating increased aortic stiffness; p= 0.065 after Bonferroni adjustment), while euglycemic-hyperinsulinemia did not. There were no changes in post-ischemic flow velocity or brachial artery flow-mediated dilation during either protocol. Plasma endothelin-1 levels significantly decreased during both protocols (each p<0.02). In this study, acute hyperglycemia for 4 hours did not inhibit insulin's ability to increase skeletal muscle microvascular perfusion but did provoke a slight increase in aortic stiffness. Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.",2020,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"['healthy young adults', 'Persons with diabetes mellitus', 'Healthy Humans']",['insulin infusion during euglycemia and hyperglycemia'],"['blood flow', 'myocardial microvascular perfusion or endothelial function', 'Hyperglycemia', 'Plasma endothelin-1 levels', 'cardiac) muscle microvascular blood volume', 'euglycemic-hyperinsulinemia', 'post-ischemic flow velocity or brachial artery flow-mediated dilation', 'aortic stiffness', 'Hyperglycemic-hyperinsulinemia', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",,0.0219329,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Horton', 'Affiliation': 'Medicine, University of Virginia, United States.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Jahn', 'Affiliation': 'endocrinology, University of Virginia, United States.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Hartline', 'Affiliation': 'University of Virginia, United States.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Aylor', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Patrie', 'Affiliation': 'Public Health Sciences, University of Virginia Medical Center, United States.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Barrett', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (, United States.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00300.2020']
2067,32830617,"The Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke.","In motor skill learning, larger doses of practice lead to greater efficacy of practice, lower efficiency of practice, and better long-term retention. Whether such learning principles apply to motor practice after stroke is unclear. Here, we developed novel mixed-effects models of the change in the perceived quality of arm movements during and following task practice. The models were fitted to data from a recent randomized controlled trial of the effect of dose of task practice in chronic stroke. Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice. Two additional effects modulated retention: a positive ""self-practice"" effect, and a negative effect of dose. Our results further suggest that for patients with sufficient arm use post-practice, self-practice will further improve use.",2020,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.",['chronic stroke'],[],"['Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",,0.0577901,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.","[{'ForeName': 'Chunji', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Neuroscience Graduate Program, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Carolee', 'Initials': 'C', 'LastName': 'Winstein', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': ""D'Argenio"", 'Affiliation': 'Biomedical Engineering, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Schweighofer', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948609']
2068,32830625,The role of improved social support for healthy eating in a lifestyle intervention:  Texercise Select .,"OBJECTIVE


We examined the measurement and mediating role of social support in dietary intake among participants in Texercise Select, an intervention for improving lifestyle behaviours.
DESIGN


Quasi-experimental study. Participants reported their dietary intake, level of social support measured by the new Social Support for Healthy Eating scale, sociodemographics and disease profile. We conducted exploratory factor analysis for scale evaluation and structural equation modelling for mediation analysis to test if changes in dietary-specific social support mediate the relationship between the intervention and changes in dietary intake.
SETTING


Texas.
PARTICIPANTS


Community-dwelling middle-aged and older adults completed a self-reported survey at baseline and 3-month follow-up (intervention group n 211, comparison group n 175).
RESULTS


The majority of the sample was aged ≥70 years (mean 74·30, sd 8·54), female (82·1 %) and had at least two chronic conditions (63·5 %). The acceptable levels of reliability and validity of the dietary-specific social support scale were confirmed. Compared with the comparison group, the intervention group reported improved intake of fruit/vegetables and water, and improved dietary-specific social support. Improved dietary-specific social support mediated the association between intervention and change in fruit/vegetable intake, controlling for sociodemographics, number of chronic conditions and geographic residence. About 12 % of intervention effect was mediated by social support.
CONCLUSIONS


The current study confirms positive intervention effects on healthy eating, and highlights social support relating to dietary behaviours that may be helpful for healthy eating. Future research should investigate additional social support for developing healthy eating behavioural skills.",2020,"Improved dietary-specific social support mediated the association between intervention and change in fruit/vegetable intake, controlling for sociodemographics, number of chronic conditions and geographic residence.","['The majority of the sample was aged ≥70 years (mean 74·30', 'healthy eating in a lifestyle intervention', 'healthy eating', 'Community-dwelling middle-aged and older adults completed a self-reported survey at baseline and 3-month follow-up (intervention group n 211, comparison group n 175', 'sd 8·54), female (82·1 %) and had at least two chronic conditions (63·5 ', 'Texas']",[],"['reliability and validity of the dietary-specific social support scale', 'dietary intake, level of social support measured by the new Social Support for Healthy Eating scale, sociodemographics and disease profile', 'intake of fruit/vegetables and water, and improved dietary-specific social support']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]",[],"[{'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0160207,"Improved dietary-specific social support mediated the association between intervention and change in fruit/vegetable intake, controlling for sociodemographics, number of chronic conditions and geographic residence.","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Yoshikawa', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Shinduk', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Towne', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Marcia G', 'Initials': 'MG', 'LastName': 'Ory', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}]",Public health nutrition,['10.1017/S1368980020002700']
2069,32830635,Prolonged intra-operative thermal exposure in endoscopic ear surgery: is it really safe?,"OBJECTIVE


The aim of this study was to assess change in temperature, audiometric outcomes and post-operative complications following exposure to different light sources during endoscopic ear surgery.
METHOD


A total of 64 patients diagnosed with chronic otitis media with central perforation and pure conductive hearing loss underwent endoscopic type 1 tympanoplasty. The patients were randomised into two groups based on the light source used: xenon or light-emitting diode. Temperature was measured using a K type thermocouple at the promontory and round window niche. Mean temperature change with respect to operating time, mean audiometric change, incidence of vomiting in the first 24 hours, vertigo and tinnitus at the end of the first week were observed.
RESULTS


Mean temperature change showed a statistically significant difference with increasing length of operating time with the xenon light source and when the two light sources were compared for a particular time interval. Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source. When the mean audiometric change was compared between light sources for a particular frequency, statistical significance was found at 4, 6 and 8 kHz. Post-operative complications were vomiting, vertigo and tinnitus (p-values of 0.042, 0.099 and 0.147, respectively, between two groups).
CONCLUSION


Light emitting diodes are associated with less significant middle-ear temperature rises and audiometric changes at higher frequencies when compared to xenon light sources. Hence, xenon should be replaced with cooler light sources.",2020,"Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source.","['64 patients diagnosed with chronic otitis media with central perforation and pure conductive hearing loss underwent endoscopic type 1 tympanoplasty', 'endoscopic ear surgery']",['light source used: xenon or light-emitting diode'],"['vertigo and tinnitus', 'Mean audiometric change', 'change in temperature, audiometric outcomes', 'length of operating time', 'mean audiometric change', 'vomiting, vertigo and tinnitus', 'Mean temperature change with respect to operating time, mean audiometric change, incidence of vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038899', 'cui_str': 'Otologic Surgical Procedure'}]","[{'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",64.0,0.0279896,"Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}]",The Journal of laryngology and otology,['10.1017/S0022215120001449']
2070,32830802,Using Serious Games to Increase Prevention and Self-Management of Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer.,"OBJECTIVES


To examine the frequency and types of preventive and self-management behaviors reported by participants, as well as report acceptability and usability data for the electronic Symptom Self-Management Training-Chemotherapy-Induced Nausea and Vomiting (CINV) serious game.
SAMPLE &AMP; SETTING


80 adults who were aged 60 years or older and newly diagnosed with cancer were recruited from a community cancer center.
METHODS &AMP; VARIABLES


Participants were randomized to an intervention or control group. A symptom management checklist was used to record preventive and self-management behaviors used after each chemotherapy treatment at home. Acceptability and usability were assessed using a brief survey.
RESULTS


The intervention group reported using more preventive behaviors, and the control group reported using more self-management behaviors. Antiemetics were the most common strategy used, followed by dietary strategies. Participants rated all aspects of the serious game highly for usability and acceptability.
IMPLICATIONS FOR NURSING


Oncology providers can help older adults plan for self-managing treatment-related side effects at home. Recording self-management behaviors may reinforce the importance of active prevention and management of CINV.
",2020,"The intervention group reported using more preventive behaviors, and the control group reported using more self-management behaviors.","['80 adults who were aged 60 years or older and newly diagnosed with cancer were recruited from a community cancer center', 'Older Adults With Cancer', 'AMP']",[],"['usability and acceptability', 'Acceptability and usability', 'Nausea and Vomiting']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",80.0,0.0504242,"The intervention group reported using more preventive behaviors, and the control group reported using more self-management behaviors.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wochna Loerzel', 'Affiliation': 'University of Central Florida.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Clochesy', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Geddie', 'Affiliation': 'Orlando Health.'}]",Oncology nursing forum,['10.1188/20.ONF.567-576']
2071,32830855,Clinician-Patient Racial/Ethnic Concordance Influences Racial/Ethnic Minority Pain: Evidence from Simulated Clinical Interactions.,"OBJECTIVE


Racial and ethnic minorities in the United States report higher levels of both clinical and experimental pain, yet frequently receive inadequate pain treatment. Although these disparities are well documented, their underlying causes remain largely unknown. Evidence from social psychological and health disparities research suggests that clinician-patient racial/ethnic concordance may improve minority patient health outcomes. Yet whether clinician-patient racial/ethnic concordance influences pain remains poorly understood.
METHODS


Medical trainees and community members/undergraduates played the role of ""clinicians"" and ""patients,"" respectively, in simulated clinical interactions. All participants identified as non-Hispanic Black/African American, Hispanic white, or non-Hispanic white. Interactions were randomized to be either racially/ethnically concordant or discordant in a 3 (clinician race/ethnicity) × 2 (clinician-patient racial/ethnic concordance) factorial design. Clinicians took the medical history and vital signs of the patient and administered an analogue of a painful medical procedure.
RESULTS


As predicted, clinician-patient racial/ethnic concordance reduced self-reported and physiological indicators of pain for non-Hispanic Black/African American patients and did not influence pain for non-Hispanic white patients. Contrary to our prediction, concordance was associated with increased pain report in Hispanic white patients. Finally, the influence of concordance on pain-induced physiological arousal was largest for patients who reported prior experience with or current worry about racial/ethnic discrimination.
CONCLUSIONS


Our findings inform our understanding of the sociocultural factors that influence pain within medical contexts and suggest that increasing minority, particularly non-Hispanic Black/African American, physician numbers may help reduce persistent racial/ethnic pain disparities.",2020,"As predicted, clinician-patient racial/ethnic concordance reduced self-reported and physiological indicators of pain for non-Hispanic Black/African American patients and did not influence pain for non-Hispanic white patients.","['Hispanic white patients', 'All participants identified as non-Hispanic Black/African American, Hispanic white, or non-Hispanic white', 'racially/ethnically concordant or discordant in a 3 (clinician race/ethnicity', 'Medical trainees and community members/undergraduates played the role of ""clinicians"" and ""patients,"" respectively, in simulated clinical interactions']",[],"['pain-induced physiological arousal', 'pain report']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0329859,"As predicted, clinician-patient racial/ethnic concordance reduced self-reported and physiological indicators of pain for non-Hispanic Black/African American patients and did not influence pain for non-Hispanic white patients.","[{'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Gianola', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Elizabeth A Reynolds', 'Initials': 'EAR', 'LastName': 'Losin', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa258']
2072,32830894,Canakinumab to reduce deterioration of cardiac and respiratory function in SARS-CoV-2 associated myocardial injury with heightened inflammation (canakinumab in Covid-19 cardiac injury: The three C study).,"BACKGROUND


In patients with Covid-19, myocardial injury and increased inflammation are associated with morbidity and mortality. We designed a proof-of-concept randomized controlled trial to evaluate whether treatment with canakinumab prevents progressive respiratory failure and worsening cardiac dysfunction in patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation.
HYPOTHESIS


The primary hypothesis is that canakiumab will shorten time to recovery.
METHODS


The three C study (canakinumab in Covid-19 Cardiac Injury, NCT04365153) is a double-blind, randomized controlled trial comparing canakinumab 300 mg IV, 600 mg IV, or placebo in a 1:1:1 ratio in hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP). The primary endpoint is defined as the time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14 days postrandomization. The secondary endpoint is mortality at day 28. A total of 45 patients will be enrolled with an anticipated 5 month follow up period.
RESULTS


Baseline characteristics for the first 20 randomized patients reveal a predominantly male (75%), elderly population (median 67 years) with a high prevalence of hypertension (80%) and hyperlipidemia (75%). CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.
CONCLUSIONS


The three C study will provide insights regarding whether IL-1β inhibition may improve outcomes in patients with SARS-CoV2 associated myocardial injury and increased inflammation.",2020,"CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.
","['45 patients will be enrolled with an anticipated 5\u2009month follow up period', 'SARS-CoV-2 associated myocardial injury with heightened inflammation (canakinumab in Covid-19 cardiac injury', '20 randomized patients reveal a predominantly male (75%), elderly population (median 67\u2009years) with a high prevalence of hypertension (80%) and hyperlipidemia (75', 'hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP', 'patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation']","['canakinumab', 'canakinumab 300\u2009mg IV, 600\u2009mg IV, or placebo']","['progressive respiratory failure and worsening cardiac dysfunction', 'time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14\u2009days postrandomization', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035229', 'cui_str': 'Respiratory insufficiency'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",45.0,0.334155,"CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.
","[{'ForeName': 'Calvin C', 'Initials': 'CC', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Debasis', 'Initials': 'D', 'LastName': 'Sahoo', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Dugar', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Robier Aguillon', 'Initials': 'RA', 'LastName': 'Prada', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Tom Kai Ming', 'Initials': 'TKM', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Ossama K', 'Initials': 'OK', 'LastName': 'Abou Hassan', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'C5 Research, Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Prabalini', 'Initials': 'P', 'LastName': 'Rajendram', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}]",Clinical cardiology,['10.1002/clc.23451']
2073,32830901,Prefrontal Cortex Activity and Gait in Parkinson's Disease With Cholinergic and Dopaminergic Therapy.,"Degradation of striatal dopamine in Parkinson's disease (PD) may initially be supplemented by increased cognitive control mediated by cholinergic mechanisms. Shift to cognitive control of walking can be quantified by prefrontal cortex activation. Levodopa improves certain aspects of gait and worsens others, and cholinergic augmentation influence on gait and prefrontal cortex activity remains unclear. This study examined dopaminergic and cholinergic influence on gait and prefrontal cortex activity while walking in PD. A single-site, randomized, double-blind crossover trial examined effects of levodopa and donepezil in PD. Twenty PD participants were randomized, and 19 completed the trial. Participants were randomized to either levodopa + donepezil (5 mg) or levodopa + placebo treatments, with 2 weeks with treatment and a 2-week washout. The primary outcome was change in prefrontal cortex activity while walking, and secondary outcomes were change in gait and dual-task performance and attention. Levodopa decreased prefrontal cortex activity compared with off medication (effect size, -0.51), whereas the addition of donepezil reversed this decrease. Gait speed and stride length under single- and dual-task conditions improved with combined donepezil and levodopa compared with off medication (effect size, 1 for gait speed and 0.75 for stride length). Dual-task reaction time was quicker with levodopa compared with off medication (effect size, -0.87), and accuracy improved with combined donepezil and levodopa (effect size, 0.47). Cholinergic therapy, specifically donepezil 5 mg/day for 2 weeks, can alter prefrontal cortex activity when walking and improve secondary cognitive task accuracy and gait in PD. Further studies will investigate whether higher prefrontal cortex activity while walking is associated with gait changes. © 2020 International Parkinson and Movement Disorder Society.",2020,"Dual-task reaction time was quicker with levodopa compared with off medication (effect size, -0.87), and accuracy improved with combined donepezil and levodopa (effect size, 0.47).","[""Parkinson's disease (PD"", 'Twenty PD participants were randomized, and 19 completed the trial', ""Parkinson's Disease With Cholinergic and Dopaminergic Therapy""]","['donepezil', 'donepezil and levodopa', 'levodopa and donepezil', 'levodopa + placebo', 'levodopa', 'Levodopa', 'levodopa + donepezil', 'Cholinergic therapy, specifically donepezil']","['Dual-task reaction time', 'gait and prefrontal cortex activity', 'Gait speed and stride length under single- and dual-task conditions', 'prefrontal cortex activity', 'change in prefrontal cortex activity while walking, and secondary outcomes were change in gait and dual-task performance and attention', 'Prefrontal Cortex Activity and Gait', 'secondary cognitive task accuracy and gait in PD']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]",,0.0600163,"Dual-task reaction time was quicker with levodopa compared with off medication (effect size, -0.87), and accuracy improved with combined donepezil and levodopa (effect size, 0.47).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stuart', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Morris', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Giritharan', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28214']
2074,32830913,Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.,"BACKGROUND


Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.
OBJECTIVES


To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.
METHODS


The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.
RESULTS


The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm.
CONCLUSIONS


In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.",2020,"Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001).",[],"['paclitaxel', 'Paclitaxel', 'DCB with standard percutaneous transluminal angioplasty (PTA', 'Paclitaxel drug-coated balloons (DCB', 'drug-coated balloon']","['Causes of death', 'rate of long-term vital status ascertainment', 'cumulative incidence of mortality', 'reduced risk of CD-TLR', 'mortality', 'mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR']",[],"[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",,0.412089,"Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Schneider', 'Affiliation': 'Division of Vascular and Endovascular Surgery, University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': 'Medtronic Inc., Minneapolis, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Laird', 'Affiliation': 'Adventist Heart and Vascular Institute, St. Helena, California.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Soga', 'Affiliation': 'Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Micari', 'Affiliation': 'Humanitas Gavazzeni Hospital, Bergamo, Italy.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ansel', 'Affiliation': 'Ohio Health, Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Mehdi H', 'Initials': 'MH', 'LastName': 'Shishehbor', 'Affiliation': 'Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'The Mount Sinai Hospital, New York.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ouriel', 'Affiliation': 'Syntactx, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29152']
2075,32830940,The Peritoneal Dialysis Transfer Set Replacement Procedure.,"Peritoneal dialysis transfer sets (extension lines) are replaced every six to nine months to minimize peritoneal dialysis catheter complications. The aim of this study was to compare a revised non-bag transfer set exchange procedure with the standard bag exchange procedure on nursing time, costs, and safety. Thirty-three people were randomized to two groups - a standard bag exchange procedure group (n = 16) and a non-bag transfer set exchange procedure group (n = 17). The standard bag exchange procedure took a median of 32 minutes (interquartile range [IQR] 25 to 38 minutes) compared to the non-bag transfer set exchange procedure of 6 minutes (IQR 4 to 8 minutes) (p Ò 0.0001). There was one episode of peritonitis in each group within the 72-hour follow-up period. The average cost of the non-bag transfer set exchange procedure was $24.54 lower, a 37% cost reduction. This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.",2020,"This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.",['Thirty-three people'],"['standard bag exchange procedure group (n = 16) and a non-bag transfer set exchange procedure group', 'Peritoneal dialysis transfer sets (extension lines', 'standard bag exchange procedure']","['nursing time, costs, and safety', 'episode of peritonitis', 'average cost of the non-bag transfer set exchange procedure']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184030', 'cui_str': 'Transfer set'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0184030', 'cui_str': 'Transfer set'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",33.0,0.0246448,"This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.","[{'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Funes', 'Affiliation': 'Former Center Manager, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Velasquez', 'Affiliation': 'Former Center Manager, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Doss-McQuitty', 'Affiliation': 'Director of Clinical Programs and Research, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Wael F', 'Initials': 'WF', 'LastName': 'Hussein', 'Affiliation': 'Senior Research Director, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Abra', 'Affiliation': 'Senior Medical Director, Satellite Healthcare, San Jose, CA. and Division of Nephrology, Department of Medicine, Stanford University School of Medicine Stanford University, Palo Alto, CA.'}, {'ForeName': 'Pon', 'Initials': 'P', 'LastName': 'Anantiyo', 'Affiliation': 'Vice President of Home Services, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Bennett', 'Affiliation': 'Director of Research, Satellite Healthcare, San Jose, CA; an Honorary Professor of Nursing, Faculty of Health, Deakin University. Melbourne, Australia.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Chief Medical Officer, Satellite Healthcare, San Jose, CA; and an Adjunct Lecturer, Division of Nephrology, Department of Medicine, Stanford University School of Medicine Stanford University, Palo Alto, CA.'}]",Nephrology nursing journal : journal of the American Nephrology Nurses' Association,[]
2076,32830992,"Effects of Eight Interval Training Sessions in Hypoxia on Anaerobic, Aerobic, and High Intensity Work Capacity in Endurance Cyclists.","Aim:  This study aimed to determine if eight sessions of supramaximal but steady-state, set duration interval training in hypoxia enhanced measured anaerobic capacity and work performed during high intensity exercise.  Materials and Methods:  Eighteen cyclists ( V̇ O 2peak : 57 ± 7 ml·kg -1 ·min -1 ) were pair-matched for anaerobic capacity determined by maximal accumulated oxygen deficit (MAOD) and allocated to a 4-week interval training in hypoxia (IHT; FiO 2  = 14.7% ± 0.5%,  n  = 9) or interval training in normoxia (NORM; FiO 2  = 20.6% ± 0.3%,  n  = 9). Cyclists completed twice weekly interval training (8 × 1 minutes: ∼120%  V̇ O 2peak , 5 minutes recovery: ∼50%  V̇ O 2peak ) in addition to their habitual training. Before and after the intervention, a constant work rate supramaximal time to fatigue and a graded exercise test were used to determine changes in anaerobic capacity/supramaximal work performed and aerobic capacity/peak aerobic power output, respectively.  Results:  No interaction or main effects were observed. Using indirect calorimetry, anaerobic capacity was not significantly different in either group pre- to postintervention using MAOD (IHT: 4% ± 15%; NORM: -5% ± 12%) or gross efficiency methods (IHT: 7% ± 14%; NORM: -2% ± 9%), and VO 2peak  was unchanged (IHT: 1% ± 6%; NORM: 1% ± 4%). However, within-group analysis shows that supramaximal work performed improved with IHT (14% ± 13%;  p  = 0.02;  d  = 0.42) but not NORM (1% ± 22%), and peak aerobic power output increased with IHT (5% ± 7%;  p  = 0.04;  d  = 0.32) but not NORM (2% ± 4%).  Conclusion:  Steady-state, set duration supramaximal interval training in hypoxia appears to provide a small beneficial effect on work capacity during supramaximal and high intensity exercise.",2020,"Using indirect calorimetry, anaerobic capacity was not significantly different in either group pre- to postintervention using MAOD (IHT: 4% ± 15%; NORM: -5% ± 12%) or gross efficiency methods (IHT: 7% ± 14%; NORM: -2% ± 9%), and VO 2peak  was unchanged (IHT: 1% ± 6%; NORM: 1% ± 4%).","['Eighteen cyclists ( V̇', 'Endurance Cyclists']","['O 2peak : 57\u2009±\u20097\u2009ml·kg -1 ·min -1 ) were pair-matched for anaerobic capacity determined by maximal accumulated oxygen deficit (MAOD) and allocated to a 4-week interval training in hypoxia (IHT; FiO 2 \u2009=\u200914.7%\u2009±\u20090.5%,  n \u2009=\u20099) or interval training in normoxia (NORM; FiO 2 \u2009=\u200920.6%\u2009±\u20090.3%,  n \u2009=\u20099', 'Eight Interval Training Sessions', 'supramaximal but steady-state, set duration interval training']","['Hypoxia on Anaerobic, Aerobic, and High Intensity Work Capacity', 'peak aerobic power output', 'anaerobic capacity/supramaximal work performed and aerobic capacity/peak aerobic power output, respectively', 'supramaximal work performed improved with IHT', 'indirect calorimetry, anaerobic capacity', 'VO 2peak']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}]",,0.0291013,"Using indirect calorimetry, anaerobic capacity was not significantly different in either group pre- to postintervention using MAOD (IHT: 4% ± 15%; NORM: -5% ± 12%) or gross efficiency methods (IHT: 7% ± 14%; NORM: -2% ± 9%), and VO 2peak  was unchanged (IHT: 1% ± 6%; NORM: 1% ± 4%).","[{'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Arezzolo', 'Affiliation': 'Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Vernon G', 'Initials': 'VG', 'LastName': 'Coffey', 'Affiliation': 'Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Nuala M', 'Initials': 'NM', 'LastName': 'Byrne', 'Affiliation': 'School of Health Sciences, University of Tasmania, Newnham, Australia.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Doering', 'Affiliation': 'Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.'}]",High altitude medicine & biology,['10.1089/ham.2020.0066']
2077,32831069,Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.,"BACKGROUND


Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300 mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300 mg course is not yet established. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed.
METHODS AND DESIGN


We are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150 mg/day (30d/150 mg) vs. BZN 60d/300 mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum, and follow them up with the following specific aims: Specific aim 1: to measure the effect of BZN 30d/150 mg compared to 60d/300 mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately and 10 months after treatment. Specific aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption.
TRIAL REGISTRATION


ClinicalTrials.gov . Identifier: NCT03672487 . Registered 14 September 2018.",2020,"BACKGROUND


Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life.","['cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy', 'treated women when pregnant later in life', 'women of reproductive age (BETTY', 'women of reproductive age', 'cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum']","['BZN 150\u2009mg/day (30d/150\u2009mg) vs. BZN 60d/300', 'Benznidazole treatment', 'BZN 30d/150\u2009mg compared to 60d/300\u2009mg preconceptional treatment', 'Benznidazole (BZN']","['frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR', 'Trypanosoma cruzi parasitic load']","[{'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0053230', 'cui_str': 'benznidazole'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0041221', 'cui_str': 'Trypanosoma cruzi'}, {'cui': 'C3178765', 'cui_str': 'Parasitic Load'}]",,0.409211,"BACKGROUND


Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life.","[{'ForeName': 'María L', 'Initials': 'ML', 'LastName': 'Cafferata', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina. mcafferata@iecs.org.ar.'}, {'ForeName': 'María A', 'Initials': 'MA', 'LastName': 'Toscani', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': 'Maternal and Perinatal Health. UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research (SRH), World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Belizán', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bergel', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Berrueta', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego (UCSD), San Diego, USA.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Ciganda', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Emmaria', 'Initials': 'E', 'LastName': 'Danesi', 'Affiliation': 'Centro Nacional de Diagnóstico e Investigación en Endemoepidemias (CeNDIE) ANLIS Dr. C. G. Malbrán, Buenos Aires, Argentina.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dumonteil', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Gibbons', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Gulayin', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Herrera', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}, {'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego (UCSD), San Diego, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': 'Schools of Medicine, University of California, San Diego (UCSD), San Diego, USA.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Shaffer', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Schijman', 'Affiliation': 'Laboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh), Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ""Dr. Héctor Torres"" (INGEBI), Buenos Aires, Argentina.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sosa-Estani', 'Affiliation': 'Drugs for Neglected Diseases initiative - Latin America (DNDi), Rio de Janeiro, Brazil.'}, {'ForeName': 'Candela B', 'Initials': 'CB', 'LastName': 'Stella', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Buekens', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}]",Reproductive health,['10.1186/s12978-020-00972-1']
2078,32831097,Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke.,"BACKGROUND


Hand function is often impaired after stroke, strongly affecting the ability to perform daily activities. Upper limb robotic devices have been developed to complement rehabilitation therapy offered to persons who suffered a stroke, but they rarely focus on the training of hand sensorimotor function. The primary goal of this study was to evaluate whether robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks) produces an equivalent decrease in upper limb motor impairment compared to dose-matched conventional neurocognitive therapy, when embedded in the rehabilitation program of inpatients in the subacute stage after stroke.
METHODS


A parallel-group, randomized controlled trial was conducted on subjects with subacute stroke receiving either conventional or robot-assisted neurocognitive hand therapy using a haptic device. Therapy was provided for 15, 45-min sessions over four weeks, nested within the standard therapy program. Primary outcome was the change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE) after the intervention, which was compared between groups using equivalence testing. Secondary outcome measures included upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance.
RESULTS


Thirty-three participants with stroke were enrolled. 14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study. At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.
CONCLUSIONS


Neurocognitive robot-assisted therapy of hand function allows for a non-inferior motor recovery compared to conventional dose-matched neurocognitive therapy when performed during inpatient rehabilitation in the subacute stage. This allows the early familiarization of subjects with stroke to the use of such technologies, as a first step towards minimal therapist supervision in the clinic, or directly at home after hospital discharge, to help increase the dose of hand therapy for persons with stroke.
TRIAL REGISTRATION


EUDAMED database (CIV-13-02-009921), clinicaltrials.gov (NCT02096445). Registered 26 March 2014 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02096445.",2020,"At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.
","['subjects with stroke', 'subjects with subacute stroke receiving either', 'subacute stroke', 'Thirty-three participants with stroke were enrolled', 'inpatients in the subacute stage after stroke', '14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study', 'persons with stroke']","['conventional or robot-assisted neurocognitive hand therapy using a haptic device', 'conventional dose-matched neurocognitive therapy', 'robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks', 'Neurocognitive robot-assisted rehabilitation of hand function']","['upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance', 'upper limb motor impairment', 'change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1268196', 'cui_str': 'Upper extremity part'}]",33.0,0.0737425,"At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.
","[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Ranzani', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland. relab.publications@hest.ethz.ch.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lambercy', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Metzger', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Califfi', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Regazzi', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Dinacci', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Petrillo', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rossi', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Fabio M', 'Initials': 'FM', 'LastName': 'Conti', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Gassert', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00746-7']
2079,32831109,"Effects of Bang® Keto Coffee Energy Drink on Metabolism and Exercise Performance in Resistance-Trained Adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.","BACKGROUND


Energy drinks are often consumed by the general population, as well as by active individuals seeking to enhance exercise performance and augment training adaptations. However, limited information is available regarding the efficacy of these products. Thus, the purpose of this study was to determine the effects of a commercially available caffeine- and protein-containing energy drink on metabolism and muscular performance.
METHODS


Sixteen resistance-trained males (n = 8; mean ± SD; age: 22.4 ± 4.9 years; body mass: 78.8 ± 14.0 kg; body fat: 15.3 ± 6.4%) and females (n = 8; age: 24.5 ± 4.8 years; body mass: 67.5 ± 11.9 kg; body fat: 26.6 ± 7.1%) participated in this randomized, double-blind, placebo-controlled, crossover study. Following a familiarization visit, participants completed two identical visits to the laboratory separated by 5-10 days, each of which consisted of indirect calorimetry energy expenditure (EE) assessments before and after consumption of the beverage (Bang® Keto Coffee; 130 kcal, 300 mg caffeine, 20 g protein) or placebo (30 kcal, 11 mg caffeine, 1 g protein) as well as after exercise testing. In addition, participants' subjective feelings of energy, fatigue, and focus as well as muscular performance (leg press one-repetition maximum and repetitions to fatigue, maximal isometric and isokinetic squat testing) were assessed. Multiple repeated measures ANOVAs with Tukey post-hoc tests were used to analyze data. Estimates of effect size were quantified via partial eta squared (η P 2 ) and Hedge's g.
RESULTS


A significant interaction effect was identified for EE (p < 0.001, η P 2  = 0.52) but not respiratory exchange ratio (p = 0.17, η P 2  = 0.11). Following consumption of the beverage, EE was 0.77 kcal·min - 1  greater than placebo at the post-beverage time point (p < 0.001) and 0.37 kcal·min - 1  greater than placebo at the post-exercise time point (p = 0.011). However, no between-condition differences were detected for any subjective or muscular performance outcomes.
CONCLUSIONS


The results of this study suggest that consumption of the energy drink had minimal effects on lower-body muscular performance and subjective factors in the context of a laboratory setting. However, the beverage was found to significantly increase energy expenditure compared to placebo immediately following ingestion as well as during the recovery period after an exercise bout, suggesting that active individuals may improve acute metabolic outcomes via consumption of a caffeine- and protein-containing energy drink.
TRIAL REGISTRATION


This trial was prospectively registered at ClinicalTrials.gov (Identifier: NCT04180787 ; Registered 29 November 2019).",2020,"A significant interaction effect was identified for EE (p < 0.001, η P 2  = 0.52) but not respiratory exchange ratio (p = 0.17, η P 2  = 0.11).","['Resistance-Trained Adults', 'mean\u2009±\u2009SD; age: 22.4\u2009±\u20094.9\u2009years; body mass: 78.8\u2009±\u200914.0\u2009kg; body fat: 15.3\u2009±\u20096.4%) and females (n\xa0=\u20098; age: 24.5\u2009±\u20094.8\u2009years; body mass: 67.5\u2009±\u200911.9\u2009kg; body fat: 26.6\u2009±\u20097.1', 'Sixteen resistance-trained males (n\xa0']","['caffeine- and protein-containing energy drink', 'caffeine, 20\u2009g protein) or placebo', 'placebo', 'Placebo', 'Bang® Keto Coffee Energy Drink']","['subjective or muscular performance outcomes', 'lower-body muscular performance and subjective factors', 'Metabolism and Exercise Performance', 'subjective feelings of energy, fatigue, and focus as well as muscular performance (leg press one-repetition maximum and repetitions to fatigue, maximal isometric and isokinetic squat testing', 'energy expenditure']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",,0.48176,"A significant interaction effect was identified for EE (p < 0.001, η P 2  = 0.52) but not respiratory exchange ratio (p = 0.17, η P 2  = 0.11).","[{'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Harty', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Stratton', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Escalante', 'Affiliation': 'California State University, San Bernardino, California, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Dellinger', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Abegale D', 'Initials': 'AD', 'LastName': 'Williams', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'White', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Smith', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Baylor A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Sanders', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA. grant.tinsley@ttu.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00374-5']
2080,32831151,Impact of Shenfu injection on a composite of organ dysfunction development in critically ill patients with coronavirus disease 2019 (COVID-19): A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


This study aims to determine the protection provided by Shenfu injection (a traditional Chinese medicine) against development of organ dysfunction in critically ill patients with coronavirus disease 2019 (COVID-19).
TRIAL DESIGN


This study is a multicenter, randomized, controlled, open-label, two-arm ratio 1:1, parallel group clinical trial.
PARTICIPANTS


The patients, who are aged from 18 to 75 years old, with a confirmed or suspected diagnosis of severe or critical COVID-19, will be consecutively recruited in the study, according to the guideline on diagnosis and treatment of COVID-19 (the 7 th  version) issued by National Health Commission of the People's Republic of China. Exclusion criteria include pregnant and breastfeeding women, atopy or allergies to Shenfu Injection (SFI), severe underlying disease (malignant tumor with multiple metastases, uncontrolled hemopathy, cachexia, severe malnutrition, HIV), active bleeding, obstructive pneumonia caused by lung tumor, severe pulmonary interstitial fibrosis, alveolar proteinosis and allergic alveolitis, continuous use of immunosuppressive drugs in last 6 months, organ transplantation, expected death within 48 hours, the patients considered unsuitable for this study by researchers. The study is conducted in 11 ICUs of designated hospitals for COVID-19, located in 5 cities of China.
INTERVENTION AND COMPARATOR


The enrolled patients will randomly receive 100 ml SFI (study group) or identical volume of saline (control group) twice a day for seven consecutive days. Patients in the both groups will be given usual care and the necessary supportive therapies as recommended by the latest edition of the management guidelines for COVID-19 (the 7 th  version so far).
MAIN OUTCOMES


The primary endpoint is a composite of newly developed or exacerbated organ dysfunction. This is defined as an increase in the sequential organ failure assessment (SOFA) score of two or more, indicating sepsis and involvement of at least one organ. The SOFA score will be measured for the 14 days after enrolment from the baseline (the score at randomization). The secondary endpoints are shown below: • SOFA score in total • Pneumonia severity index score • Dosage of vasoactive drugs • Ventilation free days within 28 days • Length of stay in intensive care unit • Total hospital costs to treat the patient • 28-day mortality • The incidence of adverse drug events related to SFI RANDOMISATION: The block randomization codes were generated by SAS V.9.1 for allocation of participants in this study. The ratio of random distribution is 1:1. The sealed envelope method is used for allocation concealment.
BLINDING (MASKING)


The patients and statistical personnel analyzing study data are both blinded. The blinding of group assignment is not adopted for the medical staff.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


This study is expected to recruit 300 patients with COVID-19, (150 in each group).
TRIAL STATUS


Protocol version 2.0, February 15, 2020. Patient recruitment started on February 25, and will end on August 31, 2020.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR2000030043. Registered February 21, 2020, http://www.chictr.org.cn/showprojen.aspx?proj=49866 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"This study aims to determine the protection provided by Shenfu injection (a traditional Chinese medicine) against development of organ dysfunction in critically ill patients with coronavirus disease 2019 (COVID-19).
","['Exclusion criteria include pregnant and breastfeeding women, atopy or allergies to Shenfu Injection (SFI), severe underlying disease (malignant tumor with multiple metastases, uncontrolled hemopathy, cachexia, severe malnutrition, HIV), active bleeding, obstructive pneumonia caused by lung tumor, severe pulmonary interstitial fibrosis, alveolar proteinosis and allergic alveolitis', 'Protocol version 2.0, February 15, 2020', '11 ICUs of designated hospitals for COVID-19, located in 5 cities of China', '300 patients with COVID-19, (150 in each group', 'critically ill patients with coronavirus disease 2019 (COVID-19', 'patient •', ""The patients, who are aged from 18 to 75 years old, with a confirmed or suspected diagnosis of severe or critical COVID-19, will be consecutively recruited in the study, according to the guideline on diagnosis and treatment of COVID-19 (the 7 th  version) issued by National Health Commission of the People's Republic of China""]","['Shenfu injection', 'Shenfu injection (a traditional Chinese medicine', '100 ml SFI (study group) or identical volume of saline (control group']","['SOFA score', 'SOFA score in total •', 'Pneumonia severity index score •', '28-day mortality •', 'composite of newly developed or exacerbated organ dysfunction']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C1528398', 'cui_str': 'Shen-Fu'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0747690', 'cui_str': 'Postobstructive pneumonia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0024121', 'cui_str': 'Neoplasm of lung'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0034050', 'cui_str': 'Pulmonary alveolar proteinosis'}, {'cui': 'C0002390', 'cui_str': 'Extrinsic allergic alveolitis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1528398', 'cui_str': 'Shen-Fu'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1321595', 'cui_str': 'Pneumonia severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",300.0,0.246542,"This study aims to determine the protection provided by Shenfu injection (a traditional Chinese medicine) against development of organ dysfunction in critically ill patients with coronavirus disease 2019 (COVID-19).
","[{'ForeName': 'Zong-Yu', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, P. R. China.'}, {'ForeName': 'Shou-Zhi', 'Initials': 'SZ', 'LastName': 'Fu', 'Affiliation': 'Department of Intensive Care Unit/Emergency, Wuhan Third Hospital, Wuhan university, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Critical Care Medicine, Wuchang Hospital, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Shu-Sheng', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Ke-Jian', 'Initials': 'KJ', 'LastName': 'Qian', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China.'}, {'ForeName': 'Xian-Di', 'Initials': 'XD', 'LastName': 'He', 'Affiliation': 'Department of Intensive Care Unit, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, P. R. China.'}, {'ForeName': 'Guo-Chao', 'Initials': 'GC', 'LastName': 'Zhu', 'Affiliation': 'Department of Critical Care Medicine, The Affiliated Hospital of Jianghan University, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Liang-Hai', 'Initials': 'LH', 'LastName': 'Li', 'Affiliation': 'Department of Intensive Care Unit, Jingzhou Central Hospital, The Second Clinical Medical College, Yangtze University, Jingzhou, Hubei, P. R. China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Wuhan Hospital of Traditional Chinese Medicine, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Wen-Fang', 'Initials': 'WF', 'LastName': 'Li', 'Affiliation': 'Department of Emergency and Critical Care, Changzheng Hospital, Naval Medical University, Shanghai, P. R. China.'}, {'ForeName': 'Bing-Yu', 'Initials': 'BY', 'LastName': 'Qin', 'Affiliation': ""Department of Critical Care Medicine, Henan Provincial People's Hospital, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Chen-Liang', 'Initials': 'CL', 'LastName': 'Zhou', 'Affiliation': 'Intensive Care Medicine, Eastern Campus, Renmin Hospital of Wuhan University, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Peng-Lin', 'Initials': 'PL', 'LastName': 'Ma', 'Affiliation': 'Department of Intensive Care, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, P. R. China. mapenglin1@163.com.'}]",Trials,['10.1186/s13063-020-04677-5']
2081,32831155,Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials.,"OBJECTIVES


Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events.
STUDY DESIGN


Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible.
PARTICIPANTS


Hospitalised, critically ill patients with suspected or confirmed COVID-19.
INTERVENTION AND COMPARATOR


Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo.
MAIN OUTCOME


All-cause mortality up to 28 days after randomization.
SEARCH METHODS


Systematic searching of clinicaltrials.gov , EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials.
RISK OF BIAS ASSESSMENTS


These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. We will use GRADE to assess the certainty of the evidence.
STATISTICAL ANALYSES


Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I 2  statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms).
PROSPERO REGISTRATION NUMBER


CRD42020197242 FULL PROTOCOL: The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol for the systematic review.",2020,"Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias.","['Hospitalised, critically ill patients with suspected or confirmed COVID-19', 'critically ill patients with COVID-19']","['corticosteroids', 'Corticosteroid therapy', 'standard of care or usual care or placebo', 'usual care or placebo', 'steroid (dexamethasone, hydrocortisone or methylprednisolone', 'placebo', 'hydrocortisone']",['mortality'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.518441,"Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias.","[{'ForeName': 'Jonathan A C', 'Initials': 'JAC', 'LastName': 'Sterne', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. jonathan.sterne@bristol.ac.uk.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Diaz', 'Affiliation': 'Clinical Unit, Health Emergencies Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'Research Unit, Hospital Universitario Dr. Negrin Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay -UVSQ, Paris, France.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Critical Care and Emergency Medicine, Hospital Sirio Libanês, São Paulo, Brazil.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Médecine Intensive - Réanimation, INSERM CIC1415, CHRU de Tours, Tours, France.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine & Intensive Care, Imperial College London, London, UK.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Julian P T', 'Initials': 'JPT', 'LastName': 'Higgins', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lapadula', 'Affiliation': 'Division of Infectious Diseases, San Gerardo Hospital, ASST Monza, Monza, Italy.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': 'CIC INSERM 1415 - CHRU de Tours, Hôpital Bretonneau, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Leclerc', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, CHRU de Tours, Tours, France.""}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Savović', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tomazini', 'Affiliation': 'Critical Care and Emergency Medicine, Hospital Sirio Libanês, São Paulo, Brazil.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04641-3']
2082,32831169,A stepped-wedge randomized trial on the impact of early ART initiation on HIV patients' economic welfare in Eswatini.,"Background:  Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy's economic impact remains unknown.  Methods:  We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients' economic welfare. Fourteen healthcare facilities were non-randomly matched in pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of < 350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the 'Early Initiation of ART for All' (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data was collected via standardised paper-based surveys with HIV-positive, ART-naïve adults who were neither pregnant nor breastfeeding. Outcomes were patients' time use, employment status, household expenditures and household wealth.  Results:  A total sample of 3,019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility and time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR= 1.00, [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR= 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households' asset ownership and living standards (RR=0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients' sex, age, education, timing of HIV diagnosis and ART initiation.  Conclusions:  Given the neutral effect on patients' economic welfare but positive effects on health, our findings support further investments into scaling-up immediate ART for all HIV patients.  Trial Registration:  ClinicalTrials.gov, NCT02909218 and NCT03789448; ethical approval: Eswatini National Health Service Review Board & Harvard T.H. Chan School of Public Health Review Board.",2020,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","['Fourteen healthcare facilities', ""HIV patients' economic welfare in Eswatini"", ""patients' economic welfare"", 'A total sample of 3,019 participants were interviewed over the duration of the study']","['immediate ART initiation', 'antiretroviral therapy (ART']","['Employment and household expenditures', 'time use, employment status, household expenditures and household wealth', 'non-resting time use']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",3019.0,0.412335,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","[{'ForeName': 'Janina Isabel', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'TUM School of Governance, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Cebele', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbouji', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, United States.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Vollmer', 'Affiliation': 'Development Economics, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Medical Faculty and University Hospital, Heidelberg University, Heidelberg Institute of Global Health, Heidelberg, Germany.'}, {'ForeName': 'Sikhathele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Institute of Public Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, United States.'}]",eLife,['10.7554/eLife.58487']
2083,32831177,Mobile App Use for Insomnia Self-Management in Urban Community-Dwelling Older Korean Adults: Retrospective Intervention Study.,"BACKGROUND


As an evidence-based psychotherapy for treating insomnia, cognitive behavioral therapy for insomnia (CBT-I), which helps people with sleep problems to change their unhelpful sleep-related beliefs and habits, has been well-established in older adults. Recently, the utilization of mobile CBT-I apps has been getting attention from mental health professionals and researchers; however, whether mobile CBT-I apps are usable among older users has yet to be determined.
OBJECTIVE


The aims of this study were to explore the relationships between subjective sleep quality and subjective memory complaints and depressive symptoms; to explore the relationship between perceived difficulty in mobile app use and usability of the mobile phone-based self-help CBT-I app, named MIND MORE, in urban community-dwelling Korean older adults; to compare changes in subjective sleep quality from pre-intervention to post-intervention, during which they used the mobile app over a 1-week intervention period; and evaluate adherence to the app.
METHODS


During the 2-hour training program delivered on 1 day titled ""Overcoming insomnia without medication: How to use the 'MIND MORE' mobile app for systematic self-management of insomnia"" (pre-intervention), 41 attendants were asked to gain hands-on experience with the app facilitated by therapists and volunteer workers. They were then asked to complete questionnaires on sociodemographic characteristics, subjective evaluation of mental health status (ie, depression, memory loss and impairment, and sleep problems), and app usability. For the 1-week home-based self-help CBT-I using the app (post-intervention), 9 of the 41 program attendants, who had already signed up for the pre-intervention, were guided to complete the given questionnaires on subjective evaluation of sleep quality after the 1-week intervention, specifically 8 days after the training program ended.
RESULTS


Due to missing data, 40 of 41 attendants were included in the data analysis. The main findings of this study were as follows. First, poor subjective sleep quality was associated with higher ratings of depressive symptoms (40/40; ρ=.60, P<.001) and memory complaints (40/40; ρ=.46, P=.003) at baseline. Second, significant improvements in subjective sleep quality from pre-intervention to post-intervention were observed in the older adults who used the MIND MORE app only for the 1-week intervention period (9/9; t 8 =3.74, P=.006). Third, apart from the program attendants who did not have a smartphone (2/40) or withdrew from their MIND MORE membership (3/40), those who attended the 1-day sleep education program adhered to the app from at least 2 weeks (13/35, 37%) to 8 weeks (2/35, 6%) without any further contact.
CONCLUSIONS


This study provides empirical evidence that the newly developed MIND MORE app not only is usable among older users but also could improve subjective sleep quality after a 1-week self-help intervention period.",2020,"First, poor subjective sleep quality was associated with higher ratings of depressive symptoms (40/40; ρ=.60, P<.001) and memory complaints (40/40; ρ=.46, P=.003) at baseline.","['Urban Community-Dwelling Older Korean Adults', ' 40 of 41 attendants were included in the data analysis', 'urban community-dwelling Korean older adults']","['MIND MORE\' mobile app for systematic self-management of insomnia"" (pre-intervention), 41 attendants were asked to gain hands-on experience with the app facilitated by therapists and volunteer workers', 'mobile phone-based self-help CBT-I app, named MIND MORE']","['subjective sleep quality', 'memory complaints', 'subjective sleep quality and subjective memory complaints and depressive symptoms', 'depressive symptoms', 'sociodemographic characteristics, subjective evaluation of mental health status (ie, depression, memory loss and impairment, and sleep problems), and app usability']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027365', 'cui_str': 'Name'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]",41.0,0.0524211,"First, poor subjective sleep quality was associated with higher ratings of depressive symptoms (40/40; ρ=.60, P<.001) and memory complaints (40/40; ρ=.46, P=.003) at baseline.","[{'ForeName': 'Kyungmi', 'Initials': 'K', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Yongin Severance Hospital, Yonsei University Health System, Yongin, Republic of Korea.'}, {'ForeName': 'Seoyoung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Nowon Eulji Medical Center, Eulji University, Seoul, Republic of Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Yongin Severance Hospital, Yonsei University Health System, Yongin, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/17755']
2084,32831183,Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial.,"BACKGROUND


In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country-43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households.
OBJECTIVE


The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months.
METHODS


A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package.
RESULTS


The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020.
CONCLUSIONS


The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19001.",2020,Children living in rural areas and in the poorest households suffer the most from stunting across the country-43.2% in rural areas and 51.4% in the lowest wealth quintile.,"['children younger than 5 years', 'children aged 6 to 23 months', 'Aga Khan University in Pakistan on January 4, 2017', '2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months', 'district of Rahim Yar Khan in Punjab, Pakistan', 'Children Aged 6 to 23 Months in Pakistan', 'enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age']","['Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication', 'lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC']","['Length, weight, food intake, compliance to interventions, morbidities, and other relevant data', 'reduction of stunting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0453857', 'cui_str': 'Nutritious food'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]",,0.123895,Children living in rural areas and in the poorest households suffer the most from stunting across the country-43.2% in rural areas and 51.4% in the lowest wealth quintile.,"[{'ForeName': 'Gul Nawaz', 'Initials': 'GN', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumra', 'Initials': 'S', 'LastName': 'Kureishy', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Atif', 'Initials': 'MA', 'LastName': 'Habib', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Asra Abeer', 'Initials': 'AA', 'LastName': 'Usmani', 'Affiliation': 'Medical College, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Areeba', 'Initials': 'A', 'LastName': 'Mubarik', 'Affiliation': 'Medical College, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Masawar', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Akbar', 'Affiliation': 'Benazir Income Support Programme, Government of Pakistan, Islamabad, Pakistan.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodriguez de Castro', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Alba Cecilia', 'Initials': 'AC', 'LastName': 'Garzon', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Pee', 'Affiliation': 'World Food Programme, Rome, Italy.'}, {'ForeName': 'Sajid Bashir', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}]",JMIR research protocols,['10.2196/19001']
2085,32831184,Evaluation of an Adaptive Implementation Program for Cognitive Adaptation Training for People With Severe Mental Illness: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Cognitive Adaptation Training is a psychosocial intervention that focuses on reducing the negative effects of cognitive disorders, especially executive functions such as planning and targeted action. International research has shown that Cognitive Adaptation Training enhances multiple aspects of daily functioning in people with severe mental illnesses. Despite this evidence, implementation of the intervention into routine care remains a challenge.
OBJECTIVE


In this implementation research, a newly developed implementation program based on previous experience and scientific literature, is tested. The primary aim of this research is to assess the effectiveness of the implementation program. The secondary aim of this study is to evaluate the factors that impede or facilitate the implementation of Cognitive Adaptation Training.
METHODS


To test the effectiveness of the implementation program, a multicenter cluster randomized controlled trial was conducted comparing the implementation program to a single training program in four mental health institutions in The Netherlands. Focus groups, semistructured interviews, and questionnaires were used at multiple levels of service delivery (service user, professional, team, organization) to identify factors that may hamper or facilitate implementation. The RE-AIM framework was applied to measure the implementation effectiveness. Following this framework, the primary outcomes were Reach, Intervention Effectiveness, Adoption, Implementation, and Maintenance. These are assessed before, during, and after implementation. The research had a total duration of 14 months, with a follow-up measurement at 14 months. Data will be analyzed using multilevel modeling.
RESULTS


The study was funded in April 2018. Data collection occurred between November 2018 and January 2020. In total, 21 teams of 4 mental health institutions agreed to participate. Data analysis is ongoing and results are expected to be published in December 2020.
CONCLUSIONS


This implementation research may provide important information about the implementation of psychosocial interventions in practice and may result in a program that is useful for Cognitive Adaptation Training, and possibly for psychosocial interventions in general.
TRIAL REGISTRATION


The Netherlands Trial Register (NL7989); https://www.trialregister.nl/trial/7989.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17412.",2020,"To test the effectiveness of the implementation program, a multicenter cluster randomized controlled trial was conducted comparing the implementation program to a single training program in four mental health institutions in The Netherlands.","['In total, 21 teams of 4 mental health institutions agreed to participate', 'four mental health institutions in The Netherlands', 'people with severe mental illnesses', 'People With Severe Mental Illness']","['single training program', 'Adaptive Implementation Program for Cognitive Adaptation Training', 'Cognitive Adaptation Training']","['Reach, Intervention Effectiveness, Adoption, Implementation, and Maintenance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.0828908,"To test the effectiveness of the implementation program, a multicenter cluster randomized controlled trial was conducted comparing the implementation program to a single training program in four mental health institutions in The Netherlands.","[{'ForeName': 'Michelle Thalia', 'Initials': 'MT', 'LastName': 'van Dam', 'Affiliation': 'Department of Rehabilitation, Lentis Psychiatric Institute, Zuidlaren, Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'van Weeghel', 'Affiliation': 'Parnassia Group, Parnassia Noord-Holland, Castricum, Netherlands.'}, {'ForeName': 'Stynke', 'Initials': 'S', 'LastName': 'Castelein', 'Affiliation': 'Research Department, Lentis Psychiatric Institute, Groningen, Netherlands.'}, {'ForeName': 'Gerdina Hendrika Maria', 'Initials': 'GHM', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Clinical and Developmental Neuropsychology, Faculty of Behavioural and Social Sciences, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van der Meer', 'Affiliation': 'Department of Rehabilitation, Lentis Psychiatric Institute, Zuidlaren, Netherlands.'}]",JMIR research protocols,['10.2196/17412']
2086,32831210,"Virtual reality or Isokinetic training; its effect on pain, kinesiophobia and serum stress hormones in chronic low back pain: A randomized controlled trial.","BACKGROUND


Evidence on the latest technologies in rehabilitation for reducing pain and altering serum stress hormones in low back pain (LBP) was lacking.
OBJECTIVE


To find the clinical and hormonal effects of virtual reality training (VRT) and isokinetic training (IKT) in chronic LBP patients.
METHODS


Through the simple random sampling method, 60 university football players with chronic LBP were allocated into three groups: NVRT= 20, NIKT= 20 and NCONTROL= 20. The three groups underwent different exercises for 4 weeks. Clinical (pain intensity and kinesiophobia) and hormonal (glucose, insulin, HOMA-IR, growth hormone, prolactin, ACTH and cortisol) values were measured at baseline, after 4 weeks and 6 months.
RESULTS


Four weeks following training, the VRT and IKT groups showed significant changes in pain intensity and kinesiophobia in comparison to the control group (p< 0.05). Hormonal measures also showed significant improvement in the VRT group in comparison to the other two groups (p< 0.05).
CONCLUSION


Training through virtual reality and isokinetic exercise is an effective approach in terms of pain and kinesiophobia. In terms of hormonal analysis, virtual reality shows slightly more improvements than isokinetic training in subjects with chronic LBP.",2020,"Four weeks following training, the VRT and IKT groups showed significant changes in pain intensity and kinesiophobia in comparison to the control group (p< 0.05).","['chronic LBP patients', 'chronic low back pain', 'subjects with chronic LBP', 'low back pain (LBP', '60 university football players with chronic LBP']","['isokinetic training', 'virtual reality training (VRT) and isokinetic training (IKT', 'Virtual reality or Isokinetic training', 'VRT and IKT', 'Training through virtual reality and isokinetic exercise']","['pain intensity and kinesiophobia', 'Clinical (pain intensity and kinesiophobia) and hormonal (glucose, insulin, HOMA-IR, growth hormone, prolactin, ACTH and cortisol) values', 'pain, kinesiophobia and serum stress hormones']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",,0.033376,"Four weeks following training, the VRT and IKT groups showed significant changes in pain intensity and kinesiophobia in comparison to the control group (p< 0.05).","[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abodonya', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ayman K', 'Initials': 'AK', 'LastName': 'Saleh', 'Affiliation': 'College of Medicine, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-202301']
2087,32831212,Effects of an 8-week basketball-specific proprioceptive training with a single-plane instability balance platform.,"BACKGROUND


To avoid injuries in basketball players, they are recommended to pay more attention to improve their body balance. Therefore new training methods and equipment need to be devised. This study examined the effects of an 8-week basketball-specific proprioception training program while using a new developed one plane instability balance board during warm-up for improving balance ability in basketball players. Players who obtained basketball-specific balance training were compared to a control group.
METHODS


Thirty-one male university basketball players (age: 21.35, SD = 0.605 years; height: 190.97, SD = 1.88; body mass: 86.95, SD = 2.61) participated in this study. Seventeen participants were assigned to the basketball-specific 8-week balance training group (BTG) while 14 participants served as a control group (CG). Both groups were tested with the Y balance test (YBT) and postural stability test (PST) at baseline and 8 weeks later.
RESULTS


The results indicate significant improvements in the overall YBT for both legs in BTG, but not in CG. However, no group differences were found for dynamic balance performance, but static balance (i.e., postural stability) differed between groups after 8 weeks. A statistically significant moderate inverse correlation was computed between the total score of YBT and the total score of the overall stability index (r=-0.404; p= 0.041).
CONCLUSIONS


An 8-week basketball-specific proprioception training program with a single-plane instability balance platform improved balance ability (Y balance test and postural stability test) of basketball players.",2020,"However, no group differences were found for dynamic balance performance, but static balance (i.e., postural stability) differed between groups after 8 weeks.","['basketball players', 'Thirty-one male university basketball players (age: 21.35, SD = 0.605\xa0years; height: 190.97, SD = 1.88; body mass: 86.95, SD = 2.61) participated in this study', 'Seventeen participants']","['8-week basketball-specific proprioceptive training with a single-plane instability balance platform', 'basketball-specific 8-week balance training group (BTG) while 14 participants served as a control group (CG', '8-week basketball-specific proprioception training program']","['balance ability (Y balance test and postural stability test', 'Y balance test (YBT) and postural stability test (PST', 'total score of YBT and the total score of the overall stability index', 'dynamic balance performance, but static balance (i.e., postural stability', 'overall YBT']","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C5191374', 'cui_str': '1.88'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]","[{'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",17.0,0.0234993,"However, no group differences were found for dynamic balance performance, but static balance (i.e., postural stability) differed between groups after 8 weeks.","[{'ForeName': 'Aurelijus', 'Initials': 'A', 'LastName': 'Domeika', 'Affiliation': 'Kaunas University of Technology, Kaunas, Lithuania.'}, {'ForeName': 'Agnė', 'Initials': 'A', 'LastName': 'Slapšinskaitė', 'Affiliation': 'Lithuanian University of Health Sciences, Lithuania.'}, {'ForeName': 'Selen', 'Initials': 'S', 'LastName': 'Razon', 'Affiliation': 'West Chester University, West Chester, PA, USA.'}, {'ForeName': 'Laimonas', 'Initials': 'L', 'LastName': 'Šiupšinskas', 'Affiliation': 'Lithuanian University of Health Sciences, Lithuania.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Klizienė', 'Affiliation': 'Kaunas University of Technology, Kaunas, Lithuania.'}, {'ForeName': 'Milda', 'Initials': 'M', 'LastName': 'Dubosienė', 'Affiliation': 'Kaunas University of Technology, Kaunas, Lithuania.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-208002']
2088,32831369,Efficacy of Terbinafine and Itraconazole in Different Doses and in Combination in the Treatment of Tinea Infection: A Randomized Controlled Parallel Group Open Labeled Trial with Clinico-Mycological Correlation.,"Background


There is a rising prevalence of dermatophyte infection especially in the tropics. It has been observed that the antifungals are not as effective as they used to be.
Aims


To determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of tinea infection.
Materials and Methods


Study design was a randomized parallel group trial. Patients were randomly divided into five parallel arms in which two of the standard drugs in recommended doses were compared with their double doses and with combination of both the drugs. Patients were followed up every 2 weeks. Outcomes were assessed at 4 and 8 weeks. Cure was considered as complete clinical resolution of the lesions. Fungal culture and sensitivity were done by disk diffusion method for all patients. Parametric one-way analysis of variance ( F  test) and Chi-square test were used for the analysis.
Results


Two-hundred seventy-five patients were included in the study. Itraconazole containing groups showed significantly higher cure rates than terbinafine only groups both at 4 and 8 weeks ( P  < 0.001). Itraconazole containing groups, when compared against each other, were not found to be significantly different. The outcomes between terbinafine only groups were also not significantly different. Cure rates at 8 weeks were found to be greater than that at 4 weeks for all groups which were found to be highly significant ( P  < 0.001).
Conclusions


Itraconazole seems to be more effective than terbinafine. There is no benefit in increasing the dose or using a combination regimen in the treatment of tinea. Prolonged duration of treatment is required for complete cure.",2020,Itraconazole containing groups showed significantly higher cure rates than terbinafine only groups both at 4 and 8 weeks ( P  < 0.001).,"['Two-hundred seventy-five patients were included in the study', 'Tinea Infection']","['terbinafine and itraconazole', 'Terbinafine and Itraconazole', 'Itraconazole', 'terbinafine']","['Cure rates', 'cure rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040247', 'cui_str': 'Tinea infection'}]","[{'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}]",[],275.0,0.0371664,Itraconazole containing groups showed significantly higher cure rates than terbinafine only groups both at 4 and 8 weeks ( P  < 0.001).,"[{'ForeName': 'Satyendra K', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Najuma', 'Initials': 'N', 'LastName': 'Subba', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Tilak', 'Affiliation': 'Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]",Indian journal of dermatology,['10.4103/ijd.IJD_548_19']
2089,32831447,The Relationship of Personality and Behavior Change in a Physical Activity Intervention: The Role of Conscientiousness and Healthy Neuroticism.,"This study examined the role of personality traits in a 5-week physical activity intervention study for working adults. We tested whether personality traits predicted individual differences in change in daily steps over time. Fifty-two participants ages 35 to 69 ( M   age  = 49.71,  SD  = 8.64) wore a Fitbit Zip step counter for 35 days and completed a personality questionnaire. Participants were randomly assigned to either an implementation intention group or a control group. Both groups wore a Fitbit and had the goal to increase their daily steps. For the present study, the sample was collapsed across groups. Higher conscientiousness was associated with greater increases in daily steps. Also, individuals with  healthy neuroticism , the combination of higher neuroticism and higher conscientiousness, showed greater increases in daily steps. The findings highlight that the efficacy of physical activity interventions may depend on personality traits. Intervention outcomes may be improved if personality is taken into account when designing the programs.",2020,Higher conscientiousness was associated with greater increases in daily steps.,"['Fifty-two participants ages 35 to 69 ( M   age  = 49.71,  SD  = 8.64) wore a Fitbit Zip step counter for 35 days and completed a personality questionnaire', 'working adults']","['Physical Activity Intervention', 'physical activity interventions', 'implementation intention group or a control group']",['daily steps'],"[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0453984', 'cui_str': 'Zipper'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",52.0,0.0200789,Higher conscientiousness was associated with greater increases in daily steps.,"[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Stieger', 'Affiliation': 'Brandeis University.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Robinson', 'Affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital.'}, {'ForeName': 'Alycia N', 'Initials': 'AN', 'LastName': 'Bisson', 'Affiliation': 'Brandeis University.'}, {'ForeName': 'Margie E', 'Initials': 'ME', 'LastName': 'Lachman', 'Affiliation': 'Brandeis University.'}]",Personality and individual differences,['10.1016/j.paid.2020.110224']
2090,32831459,A single-index model with multiple-links.,"In a regression model for treatment outcome in a randomized clinical trial, a treatment effect modifier is a covariate that has an interaction with the treatment variable, implying that the treatment efficacies vary across values of such a covariate. In this paper, we present a method for determining a composite variable from a set of baseline covariates, that can have a nonlinear association with the treatment outcome, and acts as a composite treatment effect modifier. We introduce a parsimonious generalization of the  single-index models  that targets the effect of the interaction between the treatment conditions and the vector of covariates on the outcome, a  single-index model with multiple-links  (SIMML) that estimates a single linear combination of the covariates (i.e., a single-index), with treatment-specific nonparametric  link  functions. The approach emphasizes a focus on the treatment-by-covariates interaction effects on the treatment outcome that are relevant for making optimal treatment decisions. Asymptotic results for estimator are obtained under possible model misspecification. A treatment decision rule based on the derived single-index is defined, and it is compared to other methods for estimating optimal treatment decision rules. An application to a clinical trial for the treatment of depression is presented.",2020,"A treatment decision rule based on the derived single-index is defined, and it is compared to other methods for estimating optimal treatment decision rules.",[],[],[],[],[],[],,0.0201833,"A treatment decision rule based on the derived single-index is defined, and it is compared to other methods for estimating optimal treatment decision rules.","[{'ForeName': 'Hyung', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Population Health, New York University, New York, NY 10016, U.S.A.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Petkova', 'Affiliation': 'Department of Population Health, New York University, New York, NY 10016, U.S.A.'}, {'ForeName': 'Thaddeus', 'Initials': 'T', 'LastName': 'Tarpey', 'Affiliation': 'Department of Population Health, New York University, New York, NY 10016, U.S.A.'}, {'ForeName': 'R Todd', 'Initials': 'RT', 'LastName': 'Ogden', 'Affiliation': 'Department of Biostatistics, Columbia University, New York, NY 10032, U.S.A.'}]",Journal of statistical planning and inference,['10.1016/j.jspi.2019.05.008']
2091,32831506,A novel approach in the management of mandibular degree II furcation defects using bone grafts in conjunction with a biomimetic agent: A randomized controlled clinical trial.,"Aim


Of the periodontal defects requiring regeneration, degree II furcation defects pose a substantial challenge to clinicians. This study was designed to evaluate the relative effectiveness of bone autograft (BA) and autologous platelet-rich fibrin (PRF) as against decalcified freeze-dried bone allograft (DFDBA) along with autologous PRF in the management of degree II mandibular furcation defects.
Materials and Methods


Fourteen patients (11 men and 3 women; mean age: 42.36 years), with bilateral degree II buccal furcation defects in the mandibular molars, were enrolled in the study. In each patient, randomly selected sites were divided into control site (site A) which received BA with PRF membrane and test site (site B) received DFDBA + PRF mixed with graft and also as a membrane using split-mouth design. Clinical parameters including plaque index, gingival index, gingival marginal levels, probing depth, and clinical attachment level were recorded at baseline and at 3 and 6 months' postsurgery. Horizontal and vertical furcation measurements were taken prior to the surgery through sounding and after degranulation. These measurements were repeated after 6 months.
Results


The mean reduction in the horizontal defect depth was 1.86 ± 0.66 mm (70.75%) in site A and 1.71 ± 0.73 mm (74.25%) in site B. The mean improvement in the vertical defect fill was 1.64 ± 0.74 mm (55.8%) in site A and 1.43 ± 1.34 mm (64.86%) in site B was achieved.
Conclusion


The use of combination therapy using either BA or DFDBA in conjunction with PRF appears to be effective in treating furcations.",2020,The mean reduction in the horizontal defect depth was 1.86 ± 0.66 mm (70.75%) in site A and 1.71 ± 0.73 mm (74.25%) in site,"['Fourteen patients (11 men and 3 women', 'mean age: 42.36 years), with bilateral degree II buccal furcation defects in the mandibular molars, were enrolled in the study']","['autologous PRF', 'bone autograft (BA) and autologous platelet-rich fibrin (PRF', 'BA with PRF membrane and test site (site B) received DFDBA + PRF mixed with graft and also as a membrane using split-mouth design']","['plaque index, gingival index, gingival marginal levels, probing depth, and clinical attachment level', 'Horizontal and vertical furcation measurements']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",14.0,0.0667579,The mean reduction in the horizontal defect depth was 1.86 ± 0.66 mm (70.75%) in site A and 1.71 ± 0.73 mm (74.25%) in site,"[{'ForeName': 'Koyyalamudi', 'Initials': 'K', 'LastName': 'Prudhvi', 'Affiliation': 'Department of Periodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Katragadda Raja', 'Initials': 'KR', 'LastName': 'Venkatesh Murthy', 'Affiliation': 'Department of Periodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_377_19']
2092,32831507,A randomized split mouth clinical study to compare the clinical outcomes of subepithelial connective graft and acellular dermal matrix in Miller's Class I recession coverage therapy.,"Background


According to the American Association of Periodontology, subepithelial connective tissue graft (SCTG) is one the most reliable surgical technique available for the treatment of gingival recession (GR) with Miller's Class I defect. However, due to its various disadvantages, alternate grafts such as acellular dermal matrix (ADM) grafts have been introduced for recession coverage. The present study compares the clinical outcome of these two grafts in treating Miller's Class I GR.
Materials and Methods


All the 15 patients participated in the study who had totally 30 bilateral Miller's Class I GR were divided randomly into SCTG group and ADM group each containing 15 defects. In the SCTG group, coronally advanced flap (CAF) with SCTG was performed, and in ADM group, CAF with ADM was done. Clinical parameters were measured on the day of surgery (baseline) and after 6 months. Data collected were statistically analyzed using paired and unpaired  t -tests.
Results


The analysis of the data collected at the baseline and 6 months later showed that there were no statistically significant differences in the recorded clinical parameters such as probing pocket depth, clinical attachment loss, and GR depth. ADM group showed a better color match than the SCTG group, while SCTG group achieved more keratinized tissue width than ADM group.
Conclusion


From the outcome of the current study, we can conclude that ADM is an efficient substitute for SCTG for treating Miller's Class I GR. However, additional studies with greater number of samples and lengthier follow-up periods are necessary to validate the present inference.",2020,"ADM group showed a better color match than the SCTG group, while SCTG group achieved more keratinized tissue width than ADM group.
","[""15 patients participated in the study who had totally 30 bilateral Miller's Class I GR"", ""Miller's Class I recession coverage therapy""]","['SCTG', 'coronally advanced flap (CAF) with SCTG', 'SCTG group and ADM', 'subepithelial connective graft and acellular dermal matrix', 'ADM']","['probing pocket depth, clinical attachment loss, and GR depth', 'keratinized tissue width']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",30.0,0.0244557,"ADM group showed a better color match than the SCTG group, while SCTG group achieved more keratinized tissue width than ADM group.
","[{'ForeName': 'Thamil Selvan', 'Initials': 'TS', 'LastName': 'Muthuraj', 'Affiliation': 'Department of Periodontics, CSI College of Dental Sciences and Research, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Somen', 'Initials': 'S', 'LastName': 'Bagchi', 'Affiliation': 'Department of Periodontics and Implantology, Dr. R Ahmed Dental College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Prasanta', 'Initials': 'P', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Department of Periodontics, Burdwan Dental College and Hospital, Bardhaman, West Bengal, India.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Department of Oral Health, Suri Super Speciality Hospital, Suri, West Bengal, India.'}, {'ForeName': 'Papita', 'Initials': 'P', 'LastName': 'Ghosh', 'Affiliation': 'Department of Periodontics and Implantology, Dr. R Ahmed Dental College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Murugan Jeyasree', 'Initials': 'MJ', 'LastName': 'Renganath', 'Affiliation': 'Department of Periodontics and Implantology, Rajas Dental College and Hospital, Tirunelveli, Tamil Nadu, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_609_19']
2093,32806954,Effect of K ATP  channel blocker glibenclamide on levcromakalim-induced headache.,"INTRODUCTION


Administration of ATP-sensitive potassium channel opener levcromakalim triggers headache in healthy volunteers and migraine attacks in migraine patients. Here, we investigated the effect of ATP-sensitive potassium channel blocker glibenclamide on levcromakalim-induced headache in healthy volunteers.
METHODS


In a randomized, double-blind, placebo-controlled, three-way cross-over study, 15 healthy volunteers aged 18-40 years were randomly allocated to receive glibenclamide and levcromakalim (day 1), glibenclamide and placebo (day 2), and placebo and placebo (day 3) on three different days separated by at least 1 week. The primary endpoints were the difference in incidence of headache and the difference in area under the curve for headache intensity scores (0-12 hours) between the days.
RESULTS


Fifteen healthy volunteers completed the 3 days of the study. More participants (12/15, 80%) developed headache on the glibenclamide-levcromakalim day compared to the glibenclamide-placebo day (5/15, 33%) ( p  = 0.01; mean difference 47%; 95% confidence interval 18-75%) and compared to the placebo-placebo day (1/15, 7%) ( p  = 0.001; mean difference 73%; 95% confidence interval 48-99%). We found no difference in headache incidence between glibenclamide-placebo day and placebo-placebo day ( p  = 0.12; mean difference 27%; 95% confidence interval 1.3-52%). The area under the curve for headache intensity was significantly larger on the glibenclamide-levcromakalim day compared to the glibenclamide-placebo day ( p  = 0.003); and compared to the placebo-placebo day ( p  = 0.001). We found no difference in the area under the curve between the glibenclamide-placebo day compared to the placebo-placebo day ( p  = 0.07). The median time to onset for headache after levcromakalim infusion with glibenclamide pretreatment was delayed (180 min) compared to levcromakalim without pretreatment (30 min) from a previously published study.
CONCLUSION


Glibenclamide administration did not cause headache, and glibenclamide pretreatment did not prevent levcromakalim-induced headache. However, glibenclamide delayed the onset of levcromakalim-induced headache. More selective blockers are needed to further elucidate the role of the ATP-sensitive potassium channel in headache initiation. Trial Registration:  ClinicalTrials.gov NCT03886922.",2020,p  = 0.001; mean difference 73%; 95% confidence interval 48-99%).,"['15 healthy volunteers aged 18-40 years', 'Fifteen healthy volunteers', 'healthy volunteers and migraine attacks in migraine patients', 'healthy volunteers']","['ATP-sensitive potassium channel opener levcromakalim triggers', 'K ATP  channel blocker glibenclamide', 'placebo-placebo', 'glibenclamide-placebo', 'glibenclamide and levcromakalim (day 1), glibenclamide and placebo (day 2), and placebo and placebo', 'glibenclamide', 'ATP-sensitive potassium channel blocker glibenclamide', 'Glibenclamide', 'placebo']","['headache', 'incidence of headache and the difference in area under the curve for headache intensity scores', 'levcromakalim-induced headache', 'area under the curve for headache intensity', 'median time to onset for headache', 'headache incidence', 'onset of levcromakalim-induced headache']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0244960', 'cui_str': 'Cromakalim, (3S-trans)-Isomer'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0244960', 'cui_str': 'Cromakalim, (3S-trans)-Isomer'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",15.0,0.445495,p  = 0.001; mean difference 73%; 95% confidence interval 48-99%).,"[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Kokoti', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Joachim S', 'Initials': 'JS', 'LastName': 'Paulsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jakob Møller', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420949863']
2094,32808504,"Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept.","BACKGROUND


Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice.
METHODS


The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC). The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02859038.",2020,Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer.,"['in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC', 'patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept', '456 subjects', 'advanced ovarian cancer']","['primary debulking surgery (PDS) to NACT-IDS', 'PDS and NACT-IDS', 'NACT-IDS', 'upfront maximal cytoreductive surgery', 'neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS', 'upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery', 'NACT', 'PDS', 'standard adjuvant chemotherapy', 'diagnostic laparoscopy or positron emission tomography/computed tomography scan', 'adjuvant chemotherapy']","['maximal time interval', 'overall survival', 'progression-free and overall survival']","[{'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0153579', 'cui_str': 'Malignant tumor of fallopian tube'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.35763,Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jae Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Korean Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Japanese Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Korean Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Aoki', 'Affiliation': 'Japanese Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xipeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecology and Obstetrics, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': ""Shanghai Gynecologic Oncology Group and Department of Gynecology, Hunan Provincial People's Hospital, Changsha, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Clinical Statistics Center, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Tingyan', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Libing', 'Initials': 'L', 'LastName': 'Xiang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China. xianglibing_123@sina.com.'}, {'ForeName': 'Aikou', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Japanese Gynecologic Oncology Group and Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e86']
2095,32810194,"Parenting support to prevent overweight during regular well-child visits in 0-3 year old children (BBOFT+ program), a cluster randomized trial on the effectiveness on child BMI and health behaviors and parenting.","BACKGROUND


Prevention of overweight during early childhood seems promising.
OBJECTIVE


To evaluate the effectiveness of the parenting-based BBOFT+ overweight prevention program on child BMI, child health behavior and parenting behavior among 0-36 month old children. BBOFT+ is an acronym for the key healthy lifestyle behaviors that are targeted in the BBOFT+ intervention: breastfeeding (B), daily breakfast (B), daily going outdoors (O), limiting sweet beverages (in Dutch, F) and minimal TV or computer time (T), complemented with healthy sleep behavior and improvement of parenting skills (+).
METHODS


A cluster randomized controlled trial in newborn children visiting well-baby clinics, comparing the BBOFT+ intervention (N = 901) with care as usual (CAU) (N = 1094). In both groups, parents received regular well-child visits (±11 visits in the first 3 years). In the intervention group, care was supplemented with the BBOFT+ program, which focuses on improving parenting skills from birth onwards to increase healthy behavior. Questionnaires were filled in at child's age 2-4 weeks, 6, 14 and 36 months. In multivariate analyses we corrected for child's birthweight, age, ethnic background, mother's educational level and BMI.
RESULTS


No differences were found in weight status at 36 months between intervention and control group children. At 6 months, BBOFT+ parents reported their child drinking less sweet beverages than control parents (48% vs 54%;p = .027), and going outdoors daily with their child less often (57% vs 62%;p = .03). At 14 months, more BBOFT+ parents than control parents reported to have breastfed for six months or longer (32% vs 29%;p = .022). At 36 months, more BBOFT+ parents than control parents reported their child going outside daily (78% vs 72%;p = .011) and having less TV/computer time on week- (38% vs 46%;p = .001) and weekend days (48% vs 56%;p = .002). Also, BBOFT+ parents reported having more parental control than control parents (3.92 vs 3.89;p = .02). No significant differences were found for daily breakfast, sleep duration and parenting practices in adjusted analyses.
CONCLUSION


The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI. The identified modifiable elements are potentially relevant for interventions that aim to prevent overweight.",2020,"The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI.","['newborn children visiting well-baby clinics', 'N = 901) with care as usual (CAU) (N = 1094', 'overweight during regular well-child visits in 0-3 year old children (BBOFT+ program', 'child BMI, child health behavior and parenting behavior among 0-36 month old children']","['parenting-based BBOFT+ overweight prevention program', 'BBOFT+ intervention', 'BBOFT']","['child health behaviors', 'child BMI and health behaviors and parenting', 'child BMI', 'child going outside daily', 'daily breakfast, sleep duration and parenting practices', 'weight status']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0458075', 'cui_str': 'Well baby'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",901.0,0.0395653,"The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI.","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Vlasblom', 'Affiliation': 'Department of Child Health, TNO, Leiden, The Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'van Grieken', 'Affiliation': 'Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Beltman', 'Affiliation': 'Department of Child Health, TNO, Leiden, The Netherlands.'}, {'ForeName': 'Monique P', 'Initials': 'MP', 'LastName': ""L'Hoir"", 'Affiliation': 'Department of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Raat', 'Affiliation': 'Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'Boere-Boonekamp', 'Affiliation': 'Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0237564']
2096,32810220,A phase 3 randomized study (HOMER) of ofatumumab vs rituximab in iNHL relapsed after rituximab-containing therapy.,"Because of high relapse rates with rituximab combinations, there is an unmet need for new therapeutic agents for treatment of indolent B-cell non-Hodgkin lymphoma (iNHL) or follicular lymphoma (FL). In previous trials, ofatumumab in combination with chemotherapy showed good results in relapsed/refractory FL pretreated with rituximab. This phase 3 trial evaluated the efficacy and safety of single-agent ofatumumab vs single-agent rituximab in rituximab-sensitive relapsed FL that relapsed at least 6 months after completing the last prior treatment with single-agent rituximab or a rituximab-containing regimen. Patients were randomized 1:1 to receive either ofatumumab (1000 mg) or rituximab (375 mg/m2) every week for 4 weeks for the induction phase, followed by once every 2 months for 4 additional doses. The primary endpoint, progression-free survival (PFS) and secondary endpoints, overall response rate (ORR) and overall survival (OS), were evaluated. Overall, 438 patients were assigned to receive ofatumumab (n = 219) and rituximab (n = 219). Baseline characteristics were similar in both arms. The independent review committee assessed whether median PFS was shorter in the ofatumumab arm than in the rituximab arm (16.33 vs 21.29 months), with no significant difference (hazard ratio, 1.15; 95% confidence interval, 0.89-1.49; P = .29) and also showed a lower ORR (50%) compared with the rituximab arm (66%). At the time of analysis, data were not matured for OS results. The number of grade >3 adverse events was higher in the ofatumumab arm (37%) than the rituximab arm (28%). Ofatumumab showed no superiority over rituximab in patients with FL who had relapsed after a rituximab-containing therapy. This study was registered at www.clinicaltrials.gov as #NCT01200589.",2020,The number of grade >3 adverse events was higher in the ofatumumab arm (37%) than the rituximab arm (28%).,"['438 patients were assigned to receive ofatumumab (n = 219) and', 'iNHL relapsed after rituximab-containing therapy', 'patients with FL who had relapsed after a rituximab-containing therapy']","['single-agent ofatumumab vs single-agent rituximab', 'ofatumumab (1000 mg) or rituximab', 'ofatumumab vs rituximab', 'rituximab-containing regimen', 'rituximab']","['number of grade >3 adverse events', 'progression-free survival (PFS) and secondary endpoints, overall response rate (ORR) and overall survival (OS', 'ORR', 'efficacy and safety', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",438.0,0.180547,The number of grade >3 adverse events was higher in the ofatumumab arm (37%) than the rituximab arm (28%).,"[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Maloney', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'Department of Hematology/Oncology, Kasugai Municipal Hospital, Aichi, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Hematology and Rheumatology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lasher', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland; and.'}, {'ForeName': 'Hiya', 'Initials': 'H', 'LastName': 'Banerjee', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}]",Blood advances,['10.1182/bloodadvances.2020001942']
2097,32811749,Improved health outcomes in integrative medicine visits may reflect differences in physician and patient behaviors compared to standard medical visits.,"OBJECTIVE


To identify differences in patient-physician interactions associated with improvements in GERD symptoms in a randomized controlled trial comparing integrative medicine and primary care/standard visits.
METHODS


We analyzed video recordings of 2-minute excerpts (thin slices) from the beginning, middle, and end of 21 study visits (11 standard, 10 integrative medicine).
RESULTS


According to blind coders' analysis of the excerpts, prospective improvement in GERD symptoms was most highly correlated with patients appearing pleased (r = 0.71, p < 0.01) and friendly (r = 0.67, p < 0.01) at the end of the visit, controlling for visit type. The combination of patient and physician smiling at the end of the visit was associated with improvement in GERD symptoms (r 2  = 0.45, p = 0.004). The physician in the integrative visits was more engaged (p = 0.009), friendly (p = 0.005), relaxed (p = 0.002), smiled longer (p = 0.006), gazed longer (p = 0.02), and gestured more (p = 0.007), compared to standard visits. Patients in integrative visits also smiled longer (p = 0.004).
CONCLUSION


The expanded history-taking questions asked by integrative clinicians may enhance relationship building, modifying patients' responses and improving patient-centered behaviors from clinicians,ultimately facilitating symptom improvement.
PRACTICE IMPLICATIONS


Analysis of nonverbal behaviors may facilitate a better understanding of patient-clinician interactions in integrative medicine visits and yield insights to improve clinical interactions in conventional medicine.",2020,"The physician in the integrative visits was more engaged (p = 0.009), friendly (p = 0.005), relaxed (p = 0.002), smiled longer (p = 0.006), gazed longer (p = 0.02), and gestured more (p = 0.007), compared to standard visits.",[],['integrative medicine and primary care/standard visits'],['GERD symptoms'],[],"[{'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0384732,"The physician in the integrative visits was more engaged (p = 0.009), friendly (p = 0.005), relaxed (p = 0.002), smiled longer (p = 0.006), gazed longer (p = 0.02), and gestured more (p = 0.007), compared to standard visits.","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Dossett', 'Affiliation': 'Division of General Internal Medicine, Geriatrics, and Bioethics, University of California, Davis, Sacramento, USA; Division of General Internal Medicine and Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Boston, USA; Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, USA. Electronic address: mdossett@ucdavis.edu.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Hall', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.014']
2098,32813928,Can abdominal hypropressive technique improve stress urinary incontinence? an assessor-blinded randomized controlled trial.,"AIM


To verify which one improves better stress urinary incontinence (SUI) symptoms: abdominal hypopressive technique (AHT) or pelvic floor muscle training (PFMT).
METHODS


Randomized controlled trial. Women with SUI who had not participated of physiotherapy program before were invited. The outcome measures were 7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron. Intervention consisted by 12 weeks of exercises program including PFMT or AHT program, in groups of maximum three women, twice a week, with physiotherapist supervision.
RESULTS


AHT and PFMT groups reduced urinary leakage episodes in 7 days, -0.64 and -1.91, respectively, but PFMT was superior, whit mean difference -1.27 (95% confidence interval [CI]: -1.92 to -0,62) and effect size was 0.94 in favor to PFMT. Regarding to total score of ICIQ-SF, both groups improved, with mean difference between groups -4.7 (95% CI: -6.90 to -2.50) and effect size was 1.04 in favor to PFMT. Manometry also presented improvement after treatment for both groups with mean difference between them of 11 (95% CI: 6.33-15.67) and effect size was 1.15 also in favor to PFMT.
CONCLUSION


Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",2020,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",['Women with SUI who had not participated of physiotherapy program before were invited'],"['PFMT', 'exercises program including PFMT or AHT program', 'hypopressive technique (AHT) or pelvic floor muscle training (PFMT']","['urinary leakage episodes', '7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron', 'SUI symptoms, quality of life impact and PFM function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",,0.168795,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.","[{'ForeName': 'Luciene A', 'Initials': 'LA', 'LastName': 'Jose-Vaz', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Carine L', 'Initials': 'CL', 'LastName': 'Andrade', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Cardoso', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Bernardes', 'Affiliation': 'Gynecology and Obstetrics Department, Urogynaecology Ambulatory Unit, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Paula M', 'Initials': 'APM', 'LastName': 'Resende', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24489']
2099,32813958,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,,2020,,[],['Lactin-V'],['Recurrence of Bacterial Vaginosis'],[],[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]",,0.111901,,"[{'ForeName': 'Janneke H H M', 'Initials': 'JHHM', 'LastName': 'van de Wijgert', 'Affiliation': 'University Medical Center Utrecht, Utrecht, the Netherlands j.h.h.vandewijgert@umcutrecht.nl.'}, {'ForeName': 'Marijn C', 'Initials': 'MC', 'LastName': 'Verwijs', 'Affiliation': 'Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}]",The New England journal of medicine,['10.1056/NEJMc2021832']
2100,32813959,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,,2020,,[],['Lactin-V'],['Recurrence of Bacterial Vaginosis'],[],[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]",,0.111901,,"[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Finucane', 'Affiliation': 'Massachusetts General Hospital, Boston, MA tfinucane@mgh.harvard.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2021832']
2101,32813960,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. Reply.,,2020,,[],['Lactin-V'],['Recurrence of Bacterial Vaginosis'],[],[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]",,0.0999453,,"[{'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California, San Francisco, San Francisco, CA craig.cohen@ucsf.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'Osel, Mountain View, CA.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hemmerling', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}]",The New England journal of medicine,['10.1056/NEJMc2021832']
2102,32814120,Development and preliminary testing of a technology-enhanced intervention to improve energy intake regulation in children.,"Interventions designed to improve children's self-regulation of energy intake have yielded mixed results. We tested the efficacy of a technology-enhanced intervention designed to teach children to eat in response to internal hunger and fullness cues. Thirty-two children (mean age 4.9 ± 0.8 y) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions, each scheduled approximately 1 week apart. The intervention was conducted across weeks 4-7 in small groups focused on teaching children how food travels through the body and how to respond to hunger and fullness signals. Children's short-term energy compensation, a measure of intake regulation, was collected at baseline and follow-up using a preloading protocol. Twenty-five minutes prior to receiving a standardized test meal, children consumed a low-energy (3 kcal) or high-energy (150 kcal) preload beverage, presented in random order at baseline and follow-up. Knowledge of intervention concepts was also assessed at baseline and follow-up. Linear mixed models were used to examine changes in short-term energy compensation and knowledge from baseline to follow-up. Knowledge related to the intervention improved from baseline to follow-up (3.5 ± 0.3 to 7.0 ± 0.3 correct responses out of a possible 10; P < 0.001). Children's energy compensation also improved from baseline to follow-up, as evidenced by a time-by-preload condition interaction (P = 0.02). However, this improvement was driven by boys who increased the adjustment for beverage energy content from baseline to follow-up (P = 0.04). Girls showed no change in energy compensation with the intervention (P = 0.58). The overall increase in knowledge, paired with the improvement in energy compensation in boys, suggests that this technology-enhanced intervention may be efficacious for some children. Further research is needed to determine whether boys and girls will benefit from different, personalized intervention strategies for obesity prevention.",2020,Girls showed no change in energy compensation with the intervention (P = 0.58).,"['Thirty-two children (mean age 4.9\u202f±\u202f0.8\u202fy) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions', 'children']","['technology-enhanced intervention', 'standardized test meal, children consumed a low-energy (3\u202fkcal) or high-energy (150\u202fkcal) preload beverage']","['energy compensation', ""Children's energy compensation""]","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",32.0,0.0189846,Girls showed no change in energy compensation with the intervention (P = 0.58).,"[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Reigh', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 110 Chandlee Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 226 Henderson Building, University Park, PA, 16802, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'The Pennsylvania State University, Center for Childhood Obesity Research and Department of Nutritional Sciences. 129 Noll Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Department of Pediatrics. 12631 East 17th Avenue, Mail Stop F-561, Academic Office Building, Room 2609; Aurora, CO, 80045, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'The Pennsylvania State University, Departments of Nutritional Sciences and Food Science. 321 Chandlee Laboratory, University Park, PA, 16802, USA. Electronic address: klk37@psu.edu.'}]",Appetite,['10.1016/j.appet.2020.104830']
2103,32814123,Application of continuous passive motion in patients with distal radius fractures: A randomized clinical trial.,"The aim of this study was to know if applying continuous passive motion (CPM) in addition to routine exercises is more effective than routine exercises alone in pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs). In this randomized controlled trial, 21 patients with non-stabilized DRF after pin removal were randomly assigned to experimental and control groups. The experimental group received stretching exercises with CPM machine for 2×15min per session. Both groups received routine exercises for 1h, three times a week for 4 weeks. The primary outcome measure was pain evaluated on a visual analog scale (VAS), and the secondary outcome measures were disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry) at 4, 6, and 12 weeks. Univariate analysis of covariance (ANCOVA) and a one-way repeated measure mixed model analysis of variance (ANOVA) were used for data analysis. Twenty-one participants completed the 12-week follow-up. Pain relief, ROM and functional improvement revealed that the treatment was successful in both groups. We detected no significant differences (p>0.05) between the two groups at the end of the follow-up period regarding pain, ROM, and function. Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.",2020,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","['patients with DRF', '21 patients with non-stabilized DRF after pin removal', 'patients with distal radius fractures']","['routine exercises', 'CPM machine', 'continuous passive motion', 'stretching exercises with CPM machine', 'continuous passive motion (CPM']","['pain, ROM, and function', 'Pain relief, ROM and functional improvement', 'pain evaluated on a visual analog scale (VAS', 'pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs', 'pain reduction, ROM and function improvement', 'disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",21.0,0.0547275,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farzad', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran; Physical therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: mfarzad@uwo.ca.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shirzadi', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran. Electronic address: ashirzadi71@gmail.com.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Farhoud', 'Affiliation': 'Orthopedic Surgery, Imam Hospital Complex, Tehran University of Medical Sciences, Joint Reconstruction Research Center, Iran. Electronic address: am_farhoud@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shafiee', 'Affiliation': 'Physical therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: eshafiee@uwo.ca.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.08.001']
2104,32814582,Gut microbiota modulation with long-chain corn bran arabinoxylan in adults with overweight and obesity is linked to an individualized temporal increase in fecal propionate.,"BACKGROUND


Variability in the health effects of dietary fiber might arise from inter-individual differences in the gut microbiota's ability to ferment these substrates into beneficial metabolites. Our understanding of what drives this individuality is vastly incomplete and will require an ecological perspective as microbiomes function as complex inter-connected communities. Here, we performed a parallel two-arm, exploratory randomized controlled trial in 31 adults with overweight and class-I obesity to characterize the effects of long-chain, complex arabinoxylan (n = 15) at high supplementation doses (female: 25 g/day; male: 35 g/day) on gut microbiota composition and short-chain fatty acid production as compared to microcrystalline cellulose (n = 16, non-fermentable control), and integrated the findings using an ecological framework.
RESULTS


Arabinoxylan resulted in a global shift in fecal bacterial community composition, reduced α-diversity, and the promotion of specific taxa, including operational taxonomic units related to Bifidobacterium longum, Blautia obeum, and Prevotella copri. Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants. The two groups showed differences in compositional shifts of the microbiota (p ≤ 0.025, PERMANOVA), and multiple linear regression (MLR) analyses revealed that the propionate response was predictable through shifts and, to a lesser degree, baseline composition of the microbiota. Principal components (PCs) derived from community data were better predictors in MLR models as compared to single taxa, indicating that arabinoxylan fermentation is the result of multi-species interactions within microbiomes.
CONCLUSION


This study showed that long-chain arabinoxylan modulates both microbiota composition and the output of health-relevant SCFAs, providing information for a more targeted application of this fiber. Variation in propionate production was linked to both compositional shifts and baseline composition, with PCs derived from shifts of the global microbial community showing the strongest associations. These findings constitute a proof-of-concept for the merit of an ecological framework that considers features of the wider gut microbial community for the prediction of metabolic outcomes of dietary fiber fermentation. This provides a basis to personalize the use of dietary fiber in nutritional application and to stratify human populations by relevant gut microbiota features to account for the inconsistent health effects in human intervention studies.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02322112 , registered on July 3, 2015. Video Abstract.",2020,"Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants.","['adults with overweight and obesity', '31 adults with overweight and class']","['long-chain, complex arabinoxylan', 'gut microbiota composition and short-chain fatty acid production as compared to microcrystalline cellulose', 'long-chain corn bran arabinoxylan']","['global shift in fecal bacterial community composition, reduced α-diversity, and the promotion of specific taxa, including operational taxonomic units related to Bifidobacterium longum, Blautia obeum, and Prevotella copri', 'compositional shifts of the microbiota', 'fecal propionate concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0353942', 'cui_str': 'Bran'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0318080', 'cui_str': 'Ruminococcus obeum'}, {'cui': 'C1195810', 'cui_str': 'Prevotella copri'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0033474', 'cui_str': 'Propanoates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",31.0,0.039378,"Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants.","[{'ForeName': 'Nguyen K', 'Initials': 'NK', 'LastName': 'Nguyen', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Deehan', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Zhengxiao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Baskota', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Perez-Muñoz', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Yunus E', 'Initials': 'YE', 'LastName': 'Tuncil', 'Affiliation': 'Food Engineering Department, Ordu University, 52200, Ordu, Turkey.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Seethaler', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, 70593, Stuttgart, Germany.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Patient Health Outcomes Research and Clinical Effectiveness Unit, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Laville', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes and Centre Européen Nutrition Santé, 69310, Pierre Bénite, France.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, 1200, Brussels, Belgium.'}, {'ForeName': 'Stephan C', 'Initials': 'SC', 'LastName': 'Bischoff', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, 70593, Stuttgart, Germany.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Hamaker', 'Affiliation': 'Whistler Center for Carbohydrate Research and Department of Food Science, Purdue University, West Lafayette, IN, 47907, USA.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Martínez', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bakal', 'Affiliation': 'Patient Health Outcomes Research and Clinical Effectiveness Unit, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada. jenswalter@ucc.ie.'}]",Microbiome,['10.1186/s40168-020-00887-w']
2105,32814593,Evaluating the effectiveness of learning ear anatomy using holographic models.,"BACKGROUND


Computer-assisted learning has been shown to be an effective means of teaching anatomy, with 3-D visualization technology more successfully improving participants' factual and spatial knowledge in comparison to traditional methods. To date, however, the effectiveness of teaching ear anatomy using 3-D holographic technology has not been studied. The present study aimed to evaluate the feasibility and effectiveness of learning ear anatomy using a holographic (HG) anatomic model in comparison to didactic lecture (DL) and a computer module (CM).
METHODS


A 3-D anatomic model of the middle and inner ear was created and displayed using presentation slides in a lecture, computer module, or via the Microsoft HoloLens. Twenty-nine medical students were randomized to one of the three interventions. All participants underwent assessment of baseline knowledge of ear anatomy. Immediately following each intervention, testing was repeated along with completion of a satisfaction survey.
RESULTS


Baseline test scores did not differ across intervention groups. All groups showed an improvement in anatomic knowledge post-intervention (p < 0.001); the improvement was equal across all interventions (p = 0.06). Participants rated the interventions equally for delivery of factual content (p = 0.96), but rated the HG higher than the DL and CM for overall effectiveness, ability to convey spatial relationships, and for learner engagement and motivation (p < 0.001).
CONCLUSIONS


These results suggest that 3-D holographic technology is an effective method of teaching ear anatomy as compared to DLs and CMs. Furthermore, it is better at engaging and motivating learners compared to traditional methods, meriting its inclusion as a tool in undergraduate medical education curriculum.",2020,All groups showed an improvement in anatomic knowledge post-intervention (p < 0.001); the improvement was equal across all interventions (p = 0.06).,['Twenty-nine medical students'],"['3-D holographic technology', 'didactic lecture (DL) and a computer module (CM', 'learning ear anatomy using a holographic (HG) anatomic model']","['delivery of factual content', 'learner engagement and motivation', 'anatomic knowledge post-intervention']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0026337', 'cui_str': 'Anatomic Models'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",29.0,0.0314857,All groups showed an improvement in anatomic knowledge post-intervention (p < 0.001); the improvement was equal across all interventions (p = 0.06).,"[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Gnanasegaram', 'Affiliation': ""Queen's University School of Medicine, 15 Arch Street, Kingston, K7L 3N6, Canada.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Leung', 'Affiliation': ""Queen's University School of Medicine, 15 Arch Street, Kingston, K7L 3N6, Canada.""}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Beyea', 'Affiliation': ""Department of Otolaryngology, Kingston Health Sciences Centre, Queen's University, 144 Brock Street, Kingston, Ontario, K7L 5G2, Canada. jason.beyea@queensu.ca.""}]",Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale,['10.1186/s40463-020-00458-x']
2106,32815991,Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.,"Importance


The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.
Objective


To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).
Design, Setting, and Participants


The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer. From January 2017 to September 2018, a total of 227 patients were enrolled. Final follow-up was in October 2018.
Interventions


Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.
Main Outcomes and Measures


The primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a noninferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.
Results


A total of 214 patients were analyzed for morbidity and mortality (105 patients in the LTG group and 109 patients in the OTG group). The mean (SD) age was 59.8 (9.4) years in the LTG group and 59.4 (9.2) years in the OTG group, and most were male (LTG group, 75 of 105 [71.4%]; OTG group, 80 of 109 [73.4%]). The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%). Intraoperative complications occurred in 3 patients (2.9%) in the LTG group and 4 patients (3.7%) in the OTG group (rate difference, -0.8%; 95% CI, -6.5% to 4.9%). In addition, there was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group (rate difference, 0.7%; 95% CI, -9.6% to 11.0%). One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group (rate difference, 1.0%; 95% CI, -2.5% to 5.2%), and the distribution of complication severity was similar between the 2 groups.
Conclusions and Relevance


The results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.
Trial Registration


ClinicalTrials.gov Identifier: NCT03007550.",2020,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","['214 patients', '105 patients in the LTG group and 109 patients in the OTG group', 'From January 2017 to September 2018, a total of 227 patients were enrolled', 'I Gastric Cancer', 'patients with clinical stage I gastric cancer']","['CLASS02', 'laparoscopic total gastrectomy (LTG', 'LTG', 'Laparoscopic vs Open Total Gastrectomy', 'LTG vs OTG with lymphadenectomy', 'conventional open total gastrectomy (OTG', 'OTG']","['overall morbidity and mortality rates', 'recovery courses and postoperative hospital stays', 'Intraoperative complications', 'mortality', 'distribution of complication severity', 'overall postoperative complication rate', 'morbidity and mortality', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}]","[{'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",227.0,0.250567,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","[{'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Union Hospital, Department of General Surgery, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Beijing Cancer Hospital, Department of General Surgery, Peking University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Renji Hospital, Department of General Surgery, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Shanghai Cancer Center, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'West China Hospital, Department of General Surgery, Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Nanfang Hospital, Department of General Surgery, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Peiwu', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, The First Hospital Affiliated to AMU, Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of General Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Naiqing', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.3152']
2107,32816002,Associations of Variation in Retinal Thickness With Visual Acuity and Anatomic Outcomes in Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With Anti-Vascular Endothelial Growth Factor Agents.,"Importance


When initiating anti-vascular endothelial growth factor (VEGF) treatment for patients with neovascular age-related macular degeneration (nAMD), knowledge of prognostic factors is important for advising patients and guiding treatment. We hypothesized that eyes with greater fluctuation in retinal thickness over time have worse outcomes than eyes with less variation.
Objective


To investigate whether visual and anatomic outcomes in eyes with nAMD initiating anti-VEGF treatment are associated with fluctuations in retinal thickness.
Design, Setting, and Participants


In this study using data from the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and the Inhibition of VEGF in Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included. Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020.
Main Outcomes and Measures


Foveal center point thicknesses (FCPTs) were extracted from 1165 study eyes from CATT and 566 study eyes from the IVAN trial, excluding those with 3 measurements or less. For each eye, the SD of FCPT was calculated. Eyes were grouped by FCPT SD quartile. Associations of FCPT SD quartile with outcomes were quantified at month 24 or the last available visit by linear or logistic regression, adjusting for baseline best-corrected visual acuity (BCVA) and randomized allocations to drug and treatment regimen, for BCVA, development of fibrosis, and development of macular atrophy.
Results


Of the 1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years. The median (interquartile range) FCPT SD was 40.2 (27.1-61.2) in the IVAN cohort and 59.0 (38.3-89.4) in the CATT cohort. After adjustment for baseline BCVA and trial allocations, BCVA worsened significantly across the quartiles of FCPT SD; the difference between the first and fourth quartiles was -6.27 Early Treatment Diabetic Retinopathy Study letters (95% CI, -8.45 to -4.09). The risk of developing fibrosis and macular atrophy also increased across FCPT SD quartiles. Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
Conclusions and Relevance


Greater variation in retinal thickness in eyes with nAMD during treatment with anti-VEGF was associated with worse BCVA and development of fibrosis and macular atrophy in these post hoc analyses, despite protocol-directed treatment frequency. Practitioners may want to consider variation in retinal thickness when advising patients about their prognosis.",2020,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","['1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years', 'Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020', 'eyes with nAMD initiating anti-VEGF treatment', 'Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included', 'patients with neovascular age-related macular degeneration (nAMD', 'Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With']","['anti-vascular endothelial growth factor (VEGF) treatment', 'Anti-Vascular Endothelial Growth Factor Agents']","['Measures\n\n\nFoveal center point thicknesses (FCPTs', 'risk of developing fibrosis and macular atrophy', 'median (interquartile range) FCPT SD']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0423421', 'cui_str': 'Atrophic macular change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",,0.209385,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3001']
2108,32817701,Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes.,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM). SC consisted of an individualized dietary advice and physical activity counseling program. The UC was a one-time group education program. The effectiveness was measured by number needed to treat (NNT) to prevent one macrosomia/large for gestational age (LGA) infant. The cost-effectiveness was measured by incremental cost-effectiveness ratio in terms of cost (2012 Chinese Yuan/US dollar) per case of macrosomia and LGA prevented. The study took both a health care system and a societal perspective. This study found that the NNT was 16/14 for macrosomia/LGA. The incremental cost for treating a pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective. The cost of preventing a case of macrosomia/LGA from the two corresponding perspectives were ¥30,032/¥26,278 ($4,775/$4,178) and ¥32,896/¥28,784 ($5,230/$4,577), respectively. Considering the potential severe adverse health and economic consequences of a macrosomia/LGA infant, our findings suggest that implementing this lifestyle intervention for women with GDM is an efficient use of health care resources.",2020,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","['women with GDM', 'Chinese women with gestational diabetes (GDM', 'Chinese women with gestational diabetes', 'pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective']","['NNT', 'shared care program (SC', 'lifestyle intervention using a 3-tier shared care approach', 'individualized dietary advice and physical activity counseling program']","['cost-effectiveness', 'cost of preventing a case of macrosomia/LGA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}]",,0.0234859,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","[{'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shao', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Huiguang', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Fuxia', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Juliana C N', 'Initials': 'JCN', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity and The Chinese University of Hong Kong-Prince of Wales Hospital-International Diabetes Federation Centre of Education, Hong Kong SAR, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States of America.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",PloS one,['10.1371/journal.pone.0237738']
2109,32817703,Effect of ventilation rate on recovery after cardiac arrest in a pediatric animal model.,"AIMS


To assess the impact of two different respiratory rates in hemodynamic, perfusion and ventilation parameters in a pediatric animal model of cardiac arrest (CA).
METHODS


An experimental randomized controlled trial was carried out in 50 piglets under asphyxial CA. After ROSC, they were randomized into two groups: 20 and 30 respirations per minute (rpm). Hemodynamic, perfusion and ventilation parameters were measured 10 minutes after asphyxia, just before ROSC and at 5, 15, 30 and 60 minutes after ROSC. Independent medians test, Kruskal-Wallis test and χ2 test, were used to compare continuous and categorical variables, respectively. Spearman's Rho was used to assess correlation between continuous variables. A p-value <0.05 was considered significant.
RESULTS


Arterial partial pressure of carbon dioxide (PaCO2) was significantly lower in the 30 rpm group after 15 minutes (41 vs. 54.5 mmHg, p <0.01), 30 minutes (39.5 vs. 51 mmHg, p < 0.01) and 60 minutes (36.5 vs. 48 mmHg, p = 0.02) of ROSC. The percentage of normoventilated subjects (PaCO2 30-50 mmHg) was significantly higher in the 30 rpm group throughout the experiment. pH normalization occurred faster in the 30 rpm group with significant differences at 60 minutes (7.40 vs. 7.34, p = 0.02). Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
CONCLUSIONS


This animal model of asphyxial CA shows that a respiratory rate of 30 rpm is more effective to reach normoventilation than 20 rpm in piglets after ROSC. This ventilation strategy seems to be safe, as it does not cause hyperventilation and does not affect hemodynamics or cerebral tissue perfusion.",2020,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
",['50 piglets under asphyxial CA'],['ventilation rate'],"['Arterial partial pressure of carbon dioxide (PaCO2', 'Lactic acid levels', 'pH normalization', 'Hemodynamic, perfusion and ventilation parameters']","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.046131,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'López', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Arias', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Domenech', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Horcajo', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Nocete', 'Affiliation': 'Gregorio Marañón Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zamora', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Sarah Nicole', 'Initials': 'SN', 'LastName': 'Fernández', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Herce', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}]",PloS one,['10.1371/journal.pone.0237736']
2110,32838353,Efficacy and Safety of Lopinavir/Ritonavir or Arbidol in Adult Patients with Mild/Moderate COVID-19: An Exploratory Randomized Controlled Trial.,"Background


Antiviral therapies against the novel coronavirus SARS-CoV-2, which has caused a global pandemic of respiratory illness called COVID-19, are still lacking.
Methods


Our study (ClinicalTrials.gov: NCT04252885, named ELACOI), was an exploratory randomized (2:2:1) controlled trial assessing the efficacy and safety of lopinavir/ritonavir (LPV/r) or arbidol monotherapy for treating patients with mild/moderate COVID-19.
Findings


This study successfully enrolled 86 patients with mild/moderate COVID-19, with 34 randomly assigned to receive LPV/r, 35 to arbidol, and 17 with no antiviral medication as control. Baseline characteristics of the three groups were comparable. The primary endpoint, the rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid, was similar between groups (all p > 0.05). There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT) at days 7 or 14 (all p > 0.05). At day 7, 8 (23.5%) patients in the LPV/r group, 3 (8.6%) in the arbidol group, and 2 (11.8%) in the control group showed a deterioration in clinical status from moderate to severe/critical (p = 0.206). Overall, 12 (35.3%) patients in the LPV/r group and 5 (14.3%) in the arbidol group experienced adverse events during the follow-up period. No apparent adverse event occurred in the control group.
Conclusions


LPV/r or arbidol monotherapy present little benefit for improving the clinical outcome of patients hospitalized with mild/moderate COVID-19 over supportive care.
Funding


This study was supported by project 2018ZX10302103-002, 2017ZX10202102-003-004, and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021).",2020,"There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT) at days 7 or 14 (all p > 0.05).","['patients with mild/moderate COVID-19', 'project 2018ZX10302103-002, 2017ZX10202102-003-004, and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021', 'Adult Patients with Mild/Moderate COVID-19', 'patients hospitalized with mild/moderate COVID-19 over supportive care', '86 patients with mild/moderate COVID-19, with 34 randomly assigned to receive LPV/r, 35 to arbidol, and 17 with no antiviral medication as control']","['Lopinavir/Ritonavir or Arbidol', 'lopinavir/ritonavir (LPV/r) or arbidol monotherapy']","['efficacy and safety', 'adverse events', 'Efficacy and Safety', 'rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid', 'rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT', 'adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1273849', 'cui_str': 'Infectious diseases (specialty)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0877252', 'cui_str': 'Antipyresis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",86.0,0.125277,"There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT) at days 7 or 14 (all p > 0.05).","[{'ForeName': 'Yueping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Weiyin', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Xiaoneng', 'Initials': 'X', 'LastName': 'Mo', 'Affiliation': ""Department of Respiration, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Peng', 'Affiliation': ""Department of Respiration, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Xudan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Lieguang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Fengyu', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': ""Institute of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Institute of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Fuchun', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Xilong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Intensive Care Unit, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}]","Med (New York, N.Y.)",['10.1016/j.medj.2020.04.001']
2111,32838370,Aerosol Risk with Noninvasive Respiratory Support in Patients with COVID-19.,"Objectives


This study evaluates aerosol production with high flow nasal cannula ( HFNC ) and noninvasive positive pressure ventilation ( NIPPV ) compared to six liters per minute by low-flow nasal cannula.
Methods


Two healthy volunteers were randomized to control (six liters per minute by low-flow nasal cannula), NIPPV, or HFNC using block randomization. NIPPV conditions were studied using continuous positive airway pressures of 5, 10, and 15 cm H 2 O with an FiO 2  of 1.0 delivered via full-face mask. HFNC conditions included flow rates of 30 and 40 liters per minute with an FiO 2  of 1.0 with and without coughing. HFNC and low-flow nasal cannula conditions were repeated with and without participants wearing a surgical mask. Six aerosol sizes (0.3, 1.0, 2.5, 5, and 10 μm) and total aerosol mass were measured at two feet and six feet from the participant's nasopharynx.
Results


There was no significant difference in aerosol production between either HFNC or NIPPV and control. There was also no significant difference with the use of procedural mask over the HFNC. There was significant variation between the two participants, but in neither case was there a difference compared to control. There was an aerosol-time trend, but there does not appear to be a difference between either flow rate, pressure, or control. Furthermore, there was no accumulation of total aerosol particles over the total duration of the experiment in both HFNC and NIPPV conditions.
Conclusions


HFNC and NIPPV did not increase aerosol production compared to six liters per minute by low-flow nasal cannula in this experiment involving healthy volunteers.This article is protected by copyright. All rights reserved.",2020,"Furthermore, there was no accumulation of total aerosol particles over the total duration of the experiment in both HFNC and NIPPV conditions.
","['Patients with COVID-19', 'healthy volunteers', 'Two healthy volunteers']","['high flow nasal cannula ( HFNC ) and noninvasive positive pressure ventilation ( NIPPV ', 'control (six liters per minute by low-flow nasal cannula), NIPPV, or HFNC using block randomization', 'HFNC and low-flow nasal cannula conditions were repeated with and without participants wearing a surgical mask']","['total aerosol particles', 'total aerosol mass', 'aerosol production', 'flow rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C3164735', 'cui_str': 'Noninvasive positive pressure ventilation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",2.0,0.0447746,"Furthermore, there was no accumulation of total aerosol particles over the total duration of the experiment in both HFNC and NIPPV conditions.
","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine University of Arizona College of Medicine Tucson AZ.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Beamer', 'Affiliation': 'Community, Environment & Policy Department, Mel & Enid Zuckerman College of Public Health University of Arizona Tucson AZ.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Billheimer', 'Affiliation': 'BIO5 Institute University of Arizona Tucson AZ.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Subbian', 'Affiliation': 'BIO5 Institute University of Arizona Tucson AZ.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Sorooshian', 'Affiliation': 'Department of Chemical & Environmental Engineering, College of Engineering University of Arizona Tucson AZ.'}, {'ForeName': 'Beth Salvagio', 'Initials': 'BS', 'LastName': 'Campbell', 'Affiliation': 'Department of Emergency Medicine University of Arizona College of Medicine Tucson Arizona.'}, {'ForeName': 'Jarrod M', 'Initials': 'JM', 'LastName': 'Mosier', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine University of Arizona College of Medicine Tucson AZ.'}]",Journal of the American College of Emergency Physicians open,['10.1002/emp2.12152']
2112,32838417,Correlation of Implant Stability between two Non-Invasive Methods Using Submerged and non submerged healing protocols; A randomized clinical trail.,"Various invasive and non-invasive methods have been used for measuring primary implant stability. Periotest damping device, and resonance frequency analysis (RFA) with the Osstell device have been classified as non-invasive methods.In this clinical randomized trial, a general correlation of primary implant stability was recorded using both the Osstell and Periotest device at the day of implant installation and 3 month after healing for the submerged and non submerged   loading protocols. The gender of included patients were investigated in the correlation of the two devices.Eighty completely edentulous patients were recruited, all patients were of age ranging from 50 to 69 years old. A single implant was installed in the midline of the completely edentulous mandible to improve retention of their lower denture. After implant installation, Implant Stability was recorded using the osstel and periotest device. Patients were then randomized into two groups using sealed envelopes; Submerged (S), and Non Submerged (NS). All ISQ and PTV were recorded at the day of implant installation, and 3 month after healing for both groups.When the ISQ was correlated to the (PTV), there was a moderate negative statistically significant correlation between the two readings, correlation coefficient= -0.466, p=0.000 . There tends to be a weak negative correlation between the two devices in the male group ,while there tends to be no correlation between the two devices in the female group After 3 month healing, there was no statistically significant correlation of the readings with in both groups ;NS and S ; Correlation coefficient =-0.014, -0.430, p=0.942, 0.052 respectively.   A strong negative statistically significant correlation between the two devices for the female group for both, NS and the S group. While there was no statistically significant correlation with in the male group for both groups.The present study concluded that there is a significant negative correlation between the two devices when recording primary implant stability, while this significance is lost after 3 month of loading when recording secondary implant stability. Gender would affect the implant stability recording, this would mainly due to the difference in bone density between the male and female group.",2020,"A strong negative statistically significant correlation between the two devices for the female group for both, NS and the S group.","['Eighty completely edentulous patients were recruited, all patients were of age ranging from 50 to 69 years old']","['sealed envelopes; Submerged (S), and Non Submerged (NS']","['Implant Stability', 'bone density', 'All ISQ and PTV']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}]",,0.0639128,"A strong negative statistically significant correlation between the two devices for the female group for both, NS and the S group.","[{'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Abdel Aal', 'Affiliation': 'Lecturer- Removable Prosthodontic department -Faculty of dentistry-Cairo university.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El Far', 'Affiliation': 'Professor - Removable Prosthodontic department -faculty of dentistry-Cairo University.'}, {'ForeName': 'Nora Mohamed', 'Initials': 'NM', 'LastName': 'Sheta', 'Affiliation': 'Associate professor - Removable Prosthodontic Department - faculty of dentistry-Cairo University.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fayyad', 'Affiliation': 'Associate Professor - Removable Prosthodontic department Faculty of dentistry-Cairo University.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'El Desouky', 'Affiliation': 'Associate professor-Department of Bio-statistics and Epidemiology , National Cancer Institute , Cairo University Cairo.'}, {'ForeName': 'Nouran Mahmoud', 'Initials': 'NM', 'LastName': 'Abdel Nabi', 'Affiliation': 'Faculty of dentistry -cairo university Associate professor Prosthodontics 25 street 263 new maadi EGYPT Cairo Cairo 19348 01001539310 Associate professor -Removable prosthodontic department- faculty of dentistry-Cairo University.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00130']
2113,32838463,"Effect of Local Infiltration Analgesia on Functional Outcomes in Total Knee Arthroplasty: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial.","Local infiltration analgesia (LIA) is a simple, surgeon-administered technique for the treatment of postoperative pain after total knee arthroplasty (TKA). The aim of the study was to investigate the efficacy of LIA and its effects on functional outcomes in TKA. A total of 135 patients with primary TKA were recruited and randomized either to receive LIA or to receive placebo injection (PI). Pain, active range of motion (ROM), knee function score, functional activities, and hospital length of stay (LOS) were assessed before surgery and from postoperative day (POD) 1 to at discharge. Lower pain scores at rest were recorded on POD1 and POD2 in the LIA group ( p  = 0.027 and  p  = 0.020, respectively). Lower pain score on walking was recorded on POD1 in the LIA group ( p  = 0.002). There was a statistically significant difference in active knee flexion between groups on POD1 ( p  = 0.038). There was a significant difference in LOS between LIA and PI groups. Shorter stay was seen in LIA group. There were no statistically significant differences between the groups in terms of knee function score and functional outcomes. LIA technique is effective for pain management in the early postoperative period. LIA added benefit for knee function in terms of active knee flexion ROM after TKA. A shorter hospital LOS was observed in LIA group. However, we did not find any differences in groups in terms of functional assessment such as ability to rise from a chair and walking capacity.The level of evidence is randomized controlled trial, level I.",2020,There was a statistically significant difference in active knee flexion between groups on POD1 ( p  = 0.038).,"['135 patients with primary TKA', 'Total Knee Arthroplasty', 'postoperative pain after total knee arthroplasty (TKA']","['Local Infiltration Analgesia', 'LIA technique', 'Local infiltration analgesia (LIA', 'LIA', 'Placebo', 'placebo injection (PI']","['Pain, active range of motion (ROM), knee function score, functional activities, and hospital length of stay (LOS', 'knee function score and functional outcomes', 'hospital LOS', 'Lower pain scores', 'POD1 and POD2', 'Shorter stay', 'LOS', 'active knee flexion', 'Lower pain score on walking', 'Functional Outcomes']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",135.0,0.255896,There was a statistically significant difference in active knee flexion between groups on POD1 ( p  = 0.038).,"[{'ForeName': 'Bayram', 'Initials': 'B', 'LastName': 'Unver', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Ertugrul', 'Initials': 'E', 'LastName': 'Yuksel', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Eymir', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Fikret', 'Initials': 'F', 'LastName': 'Maltepe', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Vasfi', 'Initials': 'V', 'LastName': 'Karatosun', 'Affiliation': 'Department of Orthopedics and Traumatology, School of Medicine, Dokuz Eylul University, Balçova, Izmir, Turkey.'}]",The journal of knee surgery,['10.1055/s-0040-1715103']
2114,32838476,Outpatient therapy for adult anorexia nervosa: Early weight gain trajectories and outcome.,"OBJECTIVE


The purpose of the study was to identify latent classes of trajectory of change in body mass index (BMI) between the initial and thirteenth session of outpatient treatment for adult anorexia nervosa and identify the association with outcome.
METHOD


Participants (n = 120) were randomised to one of three outpatient therapies.
RESULTS


Four latent classes were identified; two classes (higher, rapid and higher, moderate) had BMI > 17 kg/m 2  at initial assessment, and both gained significantly more weight over the 13 sessions compared to the other two classes. The third and fourth classes (middle, stable and low, stable) had an initial BMI of 16.44 and 15.31, respectively, and neither gained weight over the first 13 sessions. Compared to the other three classes, the higher, rapid class (N = 19, 16%) showed a significantly greater BMI increase over the first 13 sessions of therapy and a significantly higher rate of remission at end of treatment and 12-month follow-up (18-22 months post-randomisation).
CONCLUSIONS


The group with the greatest early weight gain had significantly higher levels of remission. Higher BMI at baseline without substantial early weight gain was insufficient to produce higher levels of remission than those with lower weight at baseline.",2020,"Compared to the other three classes, the higher, rapid class (N = 19, 16%) showed a significantly greater BMI increase over the first 13 sessions of therapy and a significantly higher rate of remission at end of treatment and 12-month follow-up (18-22 months post-randomisation).
","['adult anorexia nervosa', 'Participants (n = 120']",['Outpatient therapy'],"['weight', 'body mass index (BMI', 'BMI increase', 'rate of remission', 'levels of remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231254', 'cui_str': 'Increased body mass index'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",120.0,0.0357725,"Compared to the other three classes, the higher, rapid class (N = 19, 16%) showed a significantly greater BMI increase over the first 13 sessions of therapy and a significantly higher rate of remission at end of treatment and 12-month follow-up (18-22 months post-randomisation).
","[{'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Wade', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Allen', 'Affiliation': 'Eating Disorders Service, South London and Maudsley NHS Foundation Trust; Department of Psychological Medicine, Kings College London, London, UK.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research and the Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, North Dakota, USA.'}, {'ForeName': 'Anthea', 'Initials': 'A', 'LastName': 'Fursland', 'Affiliation': 'Centre for Clinical Interventions, Perth, Western Australia, Australia.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Hay', 'Affiliation': 'School of Medicine & Centre for Health Research, Western Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'McIntosh', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Touyz', 'Affiliation': 'School of Psychology, Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychological Medicine, Kings College London, London, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': 'Department of Psychological Medicine, Kings College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Eating Disorders Service, South London and Maudsley NHS Foundation Trust; Department of Psychological Medicine, Kings College London, London, UK.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2775']
2115,32838555,Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions.,"BACKGROUND


Cluster randomized trials are designed to evaluate interventions at the cluster or group level. When clusters are randomized but some clusters report no or non-analyzable data, intent-to-treat analysis, the gold standard for the analysis of randomized controlled trials, can be compromised. This article presents a very flexible statistical methodology for cluster randomized trials whose outcome is a cluster-level proportion (e.g. proportion from a cluster reporting an event) in the setting where clusters report non-analyzable data (which in general could be due to nonadherence, dropout, missingness, etc.). The approach is motivated by a previously published stratified randomized controlled trial called, ""The Randomized Recruitment Intervention Trial (RECRUIT),"" designed to examine the effectiveness of a trust-based continuous quality improvement intervention on increasing minority recruitment into clinical trials (ClinicalTrials.gov Identifier: NCT01911208).
METHODS


The novel approach exploits the use of generalized estimating equations for cluster-level reports, such that all clusters randomized at baseline are able to be analyzed, and intervention effects are presented as risk ratios. Simulation studies under different outcome missingness scenarios and a variety of intra-cluster correlations are conducted. A comparative analysis of the method with imputation and per protocol approaches for RECRUIT is presented.
RESULTS


Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate. Application to RECRUIT shows similar effect sizes when compared to the imputation and per protocol approach.
CONCLUSION


The article demonstrates that an innovative bivariate generalized estimating equations framework allows one to implement an intent-to-treat analysis to obtain risk ratios or odds ratios, for a variety of cluster randomized designs.",2020,"RESULTS


Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate.",[],['trust-based continuous quality improvement intervention'],[],[],"[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.232914,"RESULTS


Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate.","[{'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Ruosha', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Yefei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotions and Behavioral Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520936668']
2116,32838679,Cost-Effectiveness of Housing First With Assertive Community Treatment: Results From the Canadian At Home/Chez Soi Trial.,"OBJECTIVE


The At Home/Chez Soi trial for homeless individuals with mental illness showed scattered-site Housing First with Assertive Community Treatment (ACT) to be more effective than treatment as usual. This study evaluated the cost-effectiveness of Housing First with ACT and treatment as usual.
METHODS


Between October 2009 and June 2011, a total of 950 homeless individuals with serious mental illness were recruited in five Canadian cities: Vancouver, Winnipeg, Toronto, Montreal, and Moncton. Participants were randomly assigned to Housing First (N=469) or treatment as usual (N=481) and followed up for up to 24 months. The intervention consisted of scattered-site Housing First, using rent supplements, with ACT. The treatment-as-usual group had access to all other services. The perspective of society was adopted for the cost-effectiveness analysis. Days of stable housing served as the outcome measure. Retrospective questionnaires captured service use data.
RESULTS


Most (69%) of the costs of the intervention were offset by savings in other costs, such as emergency shelters, reducing the net annual cost of the intervention to about Can$6,311 per person. The incremental cost-effectiveness ratio was Can$41.73 per day of stable housing (95% confidence interval=Can$1.96-$83.70). At up to Can$60 per day, Housing First had more than an 80% chance of being cost-effective, compared with treatment as usual. Cost-effectiveness did not vary by participant characteristics.
CONCLUSIONS


Housing First with ACT appeared about as cost-effective as Housing First with intensive case management for people with moderate needs. The optimal mix between the two remains to be determined.",2020,"At up to Can$60 per day, Housing First had more than an 80% chance of being cost-effective, compared with treatment as usual.","['Between October 2009 and June 2011, a total of 950 homeless individuals with serious mental illness were recruited in five Canadian cities: Vancouver, Winnipeg, Toronto, Montreal, and Moncton', 'people with moderate needs', 'homeless individuals with mental illness']","['Housing First With Assertive Community Treatment', 'Assertive Community Treatment (ACT', 'scattered-site Housing First, using rent supplements, with ACT']","['incremental cost-effectiveness ratio', 'Cost-effectiveness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}, {'cui': 'C0439742', 'cui_str': 'Scattered'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0925054,"At up to Can$60 per day, Housing First had more than an 80% chance of being cost-effective, compared with treatment as usual.","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rabouin', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ly', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Powell', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Aubry', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Jino', 'Initials': 'J', 'LastName': 'Distasio', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Somers', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Bayoumi', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Mitton', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Erica E M', 'Initials': 'EEM', 'LastName': 'Moodie', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': 'Paula N', 'Initials': 'PN', 'LastName': 'Goering', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Psychiatry, McGill University, Montreal (Latimer); Douglas Research Centre, Montreal (Latimer, Rabouin, Cao); Montreal West Island Integrated University Health and Social Services Centre, Montreal (Ly); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal (Powell, Moodie); Department of Psychology, University of Ottawa, Ottawa (Aubry); Department of Geography, University of Winnipeg, Winnipeg, Manitoba (Distasio); Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto (Hwang); Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (Hwang, Bayoumi); Department of Psychiatry, Simon Fraser University, Burnaby, British Columbia (Somers); Dalla Lana School of Public Health, University of Toronto, Toronto (Bayoumi); School of Population and Public Health, University of British Columbia, Vancouver (Mitton); Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto (Goering, who died in May 2016).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000029']
2117,32838701,Effect of an integrated neonatal care kit on cause-specific neonatal mortality in rural Pakistan.,"BACKGROUND


In 2018, Pakistan had the world's highest neonatal mortality rate. Within Pakistan, most neonatal deaths occur in rural areas where access to health facilities is limited, and robust vital registration systems are lacking. To improve newborn survival, there is a need to better understand the causes of neonatal death in high burden settings and engage caregivers in the promotion of newborn health.
OBJECTIVE


To describe the causes of neonatal death in a rural area in Pakistan and to estimate the effect of an integrated neonatal care kit (iNCK) on cause-specific neonatal mortality.
METHODS


We analyzed data from a community-based, cluster-randomized controlled trial of 5286 neonates in Rahim Yar Khan (RYK), Punjab, Pakistan between April 2014 and August 2015. In intervention clusters, Lady Health Workers (LHW) delivered the iNCK and education on its use to pregnant women while control clusters received the local standard of care. The iNCK included interventions to prevent and identify signs of infection, identify low birthweight (LBW), and identify and manage hypothermia. Verbal autopsies were attempted for all deaths. The primary outcome was cause-specific neonatal mortality.
RESULTS


Verbal autopsies were conducted for 84 (57%) of the 147 reported neonatal deaths. The leading causes of death were infection (44%), intrapartum-related complications (26%) and prematurity/LBW (20%). There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
CONCLUSION


The major causes of neonatal deaths in RYK, Pakistan mirror the global landscape of neonatal deaths. The iNCK did not significantly reduce any cause-specific neonatal mortality.",2020,"There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
","['rural Pakistan', '5286 neonates in Rahim Yar Khan (RYK), Punjab, Pakistan between April 2014 and August 2015']","['integrated neonatal care kit', 'Lady Health Workers (LHW) delivered the iNCK and education', 'integrated neonatal care kit (iNCK']","['infection', 'low birthweight (LBW), and identify and manage hypothermia', 'neonatal deaths in RYK, Pakistan mirror the global landscape of neonatal deaths', 'neonatal deaths', 'neonatal mortality due to prematurity/LBW', 'intrapartum-related complications', 'newborn survival', 'neonatal mortality rate', 'cause-specific neonatal mortality', 'Verbal autopsies']","[{'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0004398', 'cui_str': 'Autopsy examination'}]",5286.0,0.166932,"There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Duby', 'Affiliation': 'Department of Pediatrics, McGill University , Montreal, Canada.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Pell', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Afsah', 'Initials': 'A', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Farrar', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Diego G', 'Initials': 'DG', 'LastName': 'Bassani', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Masawar', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Sajid', 'Initials': 'S', 'LastName': 'Soofi', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'Morris', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}]",Global health action,['10.1080/16549716.2020.1802952']
2118,32838710,Effect of Capsinoids Supplementation on Fat Oxidation and Muscle Glycogen Restoration During Post-exercise Recovery in Humans.,"BACKGROUND


Capsinoids (CSN), the novel non-pungent capsaicin analogs have been reported to promote metabolic health and exercise tolerance. However, the effect of CSN on fat oxidation and changes in skeletal muscle glycogen levels during post-exercise recovery has not been investigated in humans. <P> Purpose: We examined the effect of CSN supplementation on energy reliance, glycogen resynthesis and molecular proteins in the skeletal muscle of young adults during post-exercise recovery. <P> Methods: In this crossover-designed study, nine healthy adult male volunteers (aged 21.4±0.2 years, BMI 21.9±1.3 kg/m2 ) completed a 60-min cycling exercise at 70% VO2max. Participants consumed either CSN (12 mg, single dosage) or placebo capsules with a high-carbohydrate meal (2 g carb/kg bodyweight) immediately after exercise. Biopsied muscle samples (vastus lateralis), blood and gaseous samples were obtained during 3h post-exercise recovery period. <P> Results: We found that oral CSN supplementation right after exercise significantly altered the energy reliance on fat oxidation during recovery. This was evidenced by lower respiratory exchange ratio (RER) and higher fat oxidation rate in CSN trial. Despite, acute CSN dosage does not contribute to enhance the glycogen replenishment in skeletal muscle during 3h recovery. We identified no significant differences in postprandial glucose and insulin area under the curve in both trials. Western blot data showed increased muscle GLUT4 expression, but no significant response of p-Akt/Akt ratio with CSN during post-exercise recovery. <P> Conclusion: Our findings conclude that acute CSN intake could change energy reliance on fat oxidation, but unable to enhance muscle glycogen resynthesis during post-exercise recovery. Thus, ergogenic properties of CSN in relevance to muscle glycogen restoration following exercise needs to be further investigated in young adults.",2020,"Western blot data showed increased muscle GLUT4 expression, but no significant response of p-Akt/Akt ratio with CSN during post-exercise recovery.","['nine healthy adult male volunteers (aged 21.4±0.2 years, BMI 21.9±1.3 kg/m2 ) completed a', 'Humans', 'young adults', 'young adults during post-exercise recovery']","['CSN supplementation', '60-min cycling exercise at 70% VO2max', 'placebo capsules with a high-carbohydrate meal', 'Capsinoids Supplementation', 'CSN']","['skeletal muscle glycogen levels', 'lower respiratory exchange ratio (RER) and higher fat oxidation rate', 'postprandial glucose and insulin area', 'muscle GLUT4 expression', 'energy reliance on fat oxidation', 'Fat Oxidation and Muscle Glycogen Restoration']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0290627', 'cui_str': 'Reliance resin cement'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",9.0,0.082824,"Western blot data showed increased muscle GLUT4 expression, but no significant response of p-Akt/Akt ratio with CSN during post-exercise recovery.","[{'ForeName': 'Su-Fen', 'Initials': 'SF', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Changhua Christian Hospital, Changhua City. Taiwan.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Korivi', 'Affiliation': 'Exercise and Metabolism Research Center, College of Physical Education and Health Science, Zhejiang Normal University, Jinhua City, Zhejiang. China.'}, {'ForeName': 'Jung-Piao', 'Initials': 'JP', 'LastName': 'Taso', 'Affiliation': 'Center for General Education, National Taichung University of Education, Taichung City. Taiwan.'}, {'ForeName': 'Chun-Ching', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Science, Taipei City. Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Physical Education Center, National Dong Hwa University, Hualien City. Taiwan.'}, {'ForeName': 'I-Shiung', 'Initials': 'IS', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Education, National Taichung University of Education, Taichung City. Taiwan.'}]",Current pharmaceutical design,['10.2174/1381612826666200824104856']
2119,32838762,Careful conversations: an educational video to support parents in communicating about weight with their children.,"BACKGROUND


Parents may struggle to initiate healthy weight-related conversations with their children. Educational videos may be an effective tool for improving parents' knowledge and self-efficacy on this topic. The aim of this pilot study was to develop an educational video to assist parents in weight-related conversations with their child, and to assess changes in parents' self-efficacy on this topic.
METHODS


Video development was based on a scoping review and semi-structured interviews with parents. Respondent demographics and user satisfaction were assessed at pre- and post- video, and 4-6 months later. Self-efficacy scores were compared between parent groups based on weight concerns over time.
RESULTS


Fifty-seven parents participated in the video questionnaires, and 40 repeated measures 4-6 months later. Significant improvements in self-efficacy in ""raising the issue of weight"" and ""answering questions or concerns"" were found after watching the video (p ≤ 0.002) compared to baseline, and scores 4-6 months post baseline remained slightly elevated, but non-significant. Parents with concerns about their child being overweight had significantly lower perceived self-efficacy scores compared to parents with no concerns about their child's weight (p = 0.031). The video was found to be positively received and of relevance to parents across a number of different domains.
CONCLUSION(S)


Preliminary findings suggest an educational video about initiating weight-related conversations may be an effective tool for increasing parents' perceived self-efficacy in the short term. Further work is needed to validate findings in a randomized controlled trial, and with diverse parent populations.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03664492 . Registered 10 September 2018 - Retrospectively registered.",2020,"Significant improvements in self-efficacy in ""raising the issue of weight"" and ""answering questions or concerns"" were found after watching the video (p ≤ 0.002) compared to baseline, and scores 4-6 months post baseline remained slightly elevated, but non-significant.",['Registered 10 September 2018 - Retrospectively registered'],['educational video'],"['Self-efficacy scores', 'Respondent demographics and user satisfaction', 'self-efficacy scores', 'self-efficacy']","[{'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",57.0,0.0543437,"Significant improvements in self-efficacy in ""raising the issue of weight"" and ""answering questions or concerns"" were found after watching the video (p ≤ 0.002) compared to baseline, and scores 4-6 months post baseline remained slightly elevated, but non-significant.","[{'ForeName': 'Kody A', 'Initials': 'KA', 'LastName': 'Klupt', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Oreskovich', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernard-Genest', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Barkha P', 'Initials': 'BP', 'LastName': 'Patel', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dettmer', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Catharine M', 'Initials': 'CM', 'LastName': 'Walsh', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Strom', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'McPherson', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Rd, East York, Toronto, Ontario, M4G1R8, Canada.'}, {'ForeName': 'Jonah', 'Initials': 'J', 'LastName': 'Strub', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Steinberg', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Steinegger', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada.'}, {'ForeName': 'Jill K', 'Initials': 'JK', 'LastName': 'Hamilton', 'Affiliation': 'Division of Endocrinology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, M5G1X8, Canada. jill.hamilton@sickkids.ca.'}]",BMC pediatrics,['10.1186/s12887-020-02284-6']
2120,32838763,Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial.,"BACKGROUND


To assure patient-centred end-of-life care, palliative interventions need to account for patients' preferences. Advance care planning (ACP) is a structured approach that allows patients, relatives and physicians to discuss end-of-life decisions. Although ACP can improve several patient related outcomes, the implementation of ACP remains difficult. The col-ACP-study (collaborative advance care planning) will investigate a new ACP procedure (col-ACP-intervention (German: Hand-in-Hand Intervention)) in palliative cancer patients and their relatives that addresses individual values and targets barriers of communication before an ACP process.
METHODS


In a randomised controlled trial, 270 cancer patients without curative treatment options and their relatives will receive either 1) col-ACP 2) a supportive intervention (active control group) or 3) standard medical care (TAU). col-ACP comprises two steps: a) addressing various barriers of patients and relatives that discourage them from discussing end-of-life issues followed by b) a regular, structured ACP procedure. The col-ACP-intervention consists of 6 sessions. Primary endpoint is the patients' quality of life 16 weeks after randomisation. Secondary endpoints include measurements of distress; depression; communication barriers; caregivers' quality of life; existence of ACP or advance directives; the consistence of end of life care; and others. Patients will be followed up for 13 months. Multivariate analyses will be carried out. Qualitative evaluation of the intervention will be conducted.
DISCUSSION


Augmentation of a regular ACP program by a structured psycho-oncological intervention is an innovative approach to target barriers of communication about end-of-life issues. Study findings will help to understand the value of such a combined intervention in palliative care.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03387436 (Date of registration: 01/02/2018, retrospectively registered.",2020,Secondary endpoints include measurements of distress; depression; communication barriers; caregivers' quality of life; existence of ACP or advance directives; the consistence of end of life care; and others.,"['270 cancer patients without curative treatment options and their relatives will receive either', 'palliative cancer patients and their relatives', 'advanced cancer patients']","['ACP', '1) col-ACP 2) a supportive intervention (active control group) or 3) standard medical care (TAU', 'ACP procedure (col-ACP-intervention (German: Hand-in-Hand Intervention', 'Advance care planning (ACP', 'Collaborative advance care planning']","[""patients' quality of life 16\u2009weeks after randomisation"", ""measurements of distress; depression; communication barriers; caregivers' quality of life; existence of ACP or advance directives; the consistence of end of life care; and others""]","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009454', 'cui_str': 'Barrier to communication'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}]",270.0,0.103866,Secondary endpoints include measurements of distress; depression; communication barriers; caregivers' quality of life; existence of ACP or advance directives; the consistence of end of life care; and others.,"[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Seifart', 'Affiliation': 'Institutional Review Board, Clinical Ethics, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Institutional Review Board, Clinical Ethics, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Leppin', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Nagelschmidt', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.'}, {'ForeName': 'Jorge Riera', 'Initials': 'JR', 'LastName': 'Knorrenschild', 'Affiliation': 'Department of Internal Medicine, Division Hematology and Oncology, University Clinic of Gießen and Marburg, Marburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Timmesfeld', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'von Blanckenburg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Gutenbergstraße 18, 35032, Marburg, Germany. blanckep@uni-marburg.de.'}]",BMC palliative care,['10.1186/s12904-020-00629-7']
2121,32838773,TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone.,"BACKGROUND


Caring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home.
METHODS


This study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12).
RESULTS


Thirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention.
CONCLUSIONS


The Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial.
TRIAL REGISTRATION


Clinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered).",2020,"No adverse effects were identified due to the intervention.
","['informal caregivers of people with dementia living at home', 'Thirty-eight informal caregivers and their relatives', 'informal caregivers via the telephone']","['Talking Time intervention', 'telephone-based Talking Time intervention', 'usual individual self-organized care', 'preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting']","['adverse effects', 'self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12', 'self-rated psychological HRQoL scores']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.102612,"No adverse effects were identified due to the intervention.
","[{'ForeName': 'Martin Nikolaus', 'Initials': 'MN', 'LastName': 'Dichter', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Straße 12, 58453, Witten, Germany. Martin.Dichter@dzne.de.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Albers', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Straße 12, 58453, Witten, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Trutschel', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Straße 12, 58453, Witten, Germany.'}, {'ForeName': 'Armin Michael', 'Initials': 'AM', 'LastName': 'Ströbel', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Straße 12, 58453, Witten, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Seismann-Petersen', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Straße 12, 58453, Witten, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wermke', 'Affiliation': 'Clinic and Policlinic for Psychiatry and Psychotherapy, Leipzig University, Semmelweisstraße 10, 04103, Leipzig, Germany.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Halek', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Straße 12, 58453, Witten, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Berwig', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Straße 12, 58453, Witten, Germany.'}]",BMC health services research,['10.1186/s12913-020-05523-9']
2122,32838783,Community-based cluster randomized controlled trial: empowering households to identify and provide appropriate care for low-birthweight newborns in Nepal.,"BACKGROUND


Most newborn deaths occur among those of low birthweight (LBWt), due to prematurity &/or impaired fetal growth. Simple practices can substantially mitigate this risk. In low-income country settings where many births occur at home, strategies are needed that empower mothers to determine if their babies are at higher risk and, if so, to take measures to reduce risk. Earlier studies suggest that foot-length may be a good proxy for birthweight. An earlier Nepal study found a 6.9 cm cut-off performed relatively well, differentiating normal from low birthweight.
METHODS


Community-based, cluster-randomized controlled trial.
OBJECTIVE


to determine whether family-administered screening, associated with targeted messages improves care practices known to mitigate LBWt-associated risks.
PARTICIPANTS


women participating in a parent trial in rural Nepal, recruited late in pregnancy. Women were given a 6.9 cm card to assess whether the baby's foot is small; if so, to call a number on the card for advice. Follow-up visits were made over the 2 weeks following the birth, assessing for 2 behavioral outcomes: reported skin-to-skin thermal care, and care-seeking outside the home; assessed restricting to low birthweight (using 2 cutoffs: 2500 g and 2000 g). Randomization: 17 clusters intervention, 17 control. The study also documented performance along the presumed causal chain from intervention through behavioral impact.
RESULTS


2022 intervention, 2432 control. Intervention arm: 519 had birthweight < 2500 g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls). No significant difference found on care-seeking; for those < 2500 g RR 1.13 (95%CI: 0.97-1.131). A higher proportion of those in the intervention arm reported skin-to-skin thermal care than among controls; for those < 2500 g RR 2.50 (95%CI: 2.01-3.1). However, process measures suggest this apparent effect cannot be attributed to the intervention; the card performed poorly as a proxy for LBWt, misclassifying 84.5% of those < 2000 as normal weight.
CONCLUSIONS


Although the trial found an apparent effect on one of the behavioral outcomes, this cannot be attributed to the intervention; most likely it was a result of pure chance. Other approaches are needed for identifying small, at-risk babies in such settings, and targeting them for appropriate care messaging.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02802332 , registered 6/16/2016.",2020,No significant difference found on care-seeking; for those < 2500 g RR 1.13,"['women participating in a parent trial in rural Nepal, recruited late in pregnancy', 'Community-based, cluster-randomized controlled trial', 'low-birthweight newborns in Nepal', 'Intervention arm: 519 had birthweight <\u20092500\u2009g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls']","['skin-to-skin thermal care, and care-seeking outside the home; assessed restricting to low birthweight']","['care-seeking', 'skin-to-skin thermal care']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",,0.120742,No significant difference found on care-seeking; for those < 2500 g RR 1.13,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hodgins', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton Clinic Health Academy, 11405 - 87 Ave, Edmonton, Alberta, T6G 1C9, Canada. shodgins@ualberta.ca.'}, {'ForeName': 'Binamra', 'Initials': 'B', 'LastName': 'Rajbhandari', 'Affiliation': 'International Rescue Committee, 38 Main Motor Road, Wilberforce, Freetown, Sierra Leone.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Joshi', 'Affiliation': 'Save the Children, Nepal Country Office, Airport Gate Area, Shambhu Marg, Kathmandu, Nepal.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Ban', 'Affiliation': 'Independent consultant, Kathmandu, Nepal.'}, {'ForeName': 'Subarna', 'Initials': 'S', 'LastName': 'Khatry', 'Affiliation': 'Independent consultant, Kathmandu, Nepal.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21228, USA.'}]",BMC public health,['10.1186/s12889-020-09317-w']
2123,32838798,Three-dimensional printing technology for localised thoracoscopic segmental resection for lung cancer: a quasi-randomised clinical trial.,"BACKGROUND


Three-dimensional (3D) computed tomography (CT) reconstruction technology has gained attention owing to its potential in locating ground glass nodules in the lung. The 3D printing technology additionally allows the visualisation of the surrounding anatomical structure and variations. However, the clinical utility of these techniques is unknown. This study aimed to establish a lung tumour and an anatomical lung model using 3D printing and 3D chest CT reconstruction and to evaluate the clinical potential of 3D printing technology in uniportal video-assisted thoracoscopic segmentectomy.
METHODS


Eighty-nine patients with ground glass nodules who underwent uniportal video-assisted thoracoscopic segmentectomy were classified into the following groups: group A, lung models for pre-positioning and simulated surgery that were performed with 3D chest CT reconstruction and 3D printing, and group B, patients who underwent chest CT scans with image enhancement for 3D reconstruction. The differences in the surgery approach transfer rate, surgical method conversion rate, operative time, intraoperative blood loss, and postoperative complication rate were compared between the two groups.
RESULTS


Between groups A and B, there were significant differences in the approach transfer rate (0% vs.10.5%, p = 0.030), operative time (2.07 ± 0.24 h vs. 2.55 ± 0.41 h, p < 0.001), intraoperative blood loss volume (43.25 ± 13.63 mL vs. 96.68 ± 32.82 mL, p < 0.001) and the rate of surgical method conversion to lobectomy (0% vs. 10.5%, p < 0.030). In contrast, there was an insignificant difference in the postoperative complication rate between groups A and B (3.9% vs. 13.2%, p = 0.132).
CONCLUSIONS


3D printing technology facilitates a more accurate location of nodules by surgeons, as it is based on two-dimensional and 3D image-based findings, and therefore, it can improve surgical accuracy and safety. This technique is worth applying in clinical practice.",2020,", there were significant differences in the approach transfer rate (0% vs.10.5%, p = 0.030), operative time (2.07 ± 0.24 h vs. 2.55 ± 0.41 h, p < 0.001), intraoperative blood loss volume (43.25 ± 13.63 mL vs. 96.68 ± 32.82 mL,","['Eighty-nine patients with ground glass nodules who underwent', 'lung cancer']","['3D printing and 3D chest CT reconstruction', 'Three-dimensional (3D) computed tomography (CT) reconstruction technology', 'chest CT scans with image enhancement for 3D reconstruction', 'uniportal video-assisted thoracoscopic segmentectomy', 'localised thoracoscopic segmental resection', 'lung models for pre-positioning and simulated surgery that were performed with 3D chest CT reconstruction and 3D printing']","['operative time', 'postoperative complication rate', 'surgery approach transfer rate, surgical method conversion rate, operative time, intraoperative blood loss, and postoperative complication rate', 'rate of surgical method conversion to lobectomy', 'intraoperative blood loss volume', 'approach transfer rate']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0020909', 'cui_str': 'Image Quality Enhancement'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",89.0,0.0448995,", there were significant differences in the approach transfer rate (0% vs.10.5%, p = 0.030), operative time (2.07 ± 0.24 h vs. 2.55 ± 0.41 h, p < 0.001), intraoperative blood loss volume (43.25 ± 13.63 mL vs. 96.68 ± 32.82 mL,","[{'ForeName': 'Yangming', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shengli Clinical Medical College, Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Jiguang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Shengli Clinical Medical College, Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Qianshun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Shengli Clinical Medical College, Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Shengli Clinical Medical College, Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Shengli Clinical Medical College, Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Shengli Clinical Medical College, Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Shengli Clinical Medical College, Fujian Medical University, Fuzhou, 350001, China. fzlinxing@163.com.'}]",World journal of surgical oncology,['10.1186/s12957-020-01998-2']
2124,32838800,The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial.,"BACKGROUND


Osteoarthritis (OA) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs, and preferences into the decision-making process, thus improving person-centered care. Previous research has focused almost exclusively on knee OA, and therefore, the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.
METHODS


The general design consists of two phases: (1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients, and (2) to evaluate the impact of the PtDA on hip OA patients' decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.
DISCUSSION


PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04241978 . Registered on 24 January 2020.",2020,"In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs, and preferences into the decision-making process, thus improving person-centered care.","['patients with hip osteoarthritis', 'patients with hip OA', '124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0454686', 'cui_str': 'Tenerife'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],[],124.0,0.0552053,"In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs, and preferences into the decision-making process, thus improving person-centered care.","[{'ForeName': 'Lilisbeth', 'Initials': 'L', 'LastName': 'Perestelo-Pérez', 'Affiliation': 'Evaluation Unit of the Canary Islands Health Service (SESCS), Camino Candelaria, s/n. 38109, El Rosario, S/C de Tenerife, Spain. lilisbeth.peresteloperez@sescs.es.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Álvarez-Pérez', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Tenerife, Spain.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Rivero-Santana', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ramos-García', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Tenerife, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Duarte-Díaz', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Tenerife, Spain.'}, {'ForeName': 'Alezandra', 'Initials': 'A', 'LastName': 'Torres-Castaño', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Tenerife, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Toledo-Chávarri', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Herrera-Perez', 'Affiliation': 'Hospital Universitario de Canarias (HUC), Tenerife, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'País-Brito', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Del Castillo', 'Affiliation': 'Hospital San Juan de Dios de Santa Cruz de Tenerife (HSJD), Tenerife, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Vázquez', 'Affiliation': 'Gerencia de Atención Primaria de Tenerife del Servicio Canario de la Salud, Tenerife, Spain.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Orrego', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Serrano-Aguilar', 'Affiliation': 'Evaluation Unit of the Canary Islands Health Service (SESCS), Camino Candelaria, s/n. 38109, El Rosario, S/C de Tenerife, Spain.'}]",Trials,['10.1186/s13063-020-04661-z']
2125,32838803,Impact of the Maternal and Child Health handbook in Angola for improving continuum of care and other maternal and child health indicators: study protocol for a cluster randomised controlled trial.,"BACKGROUND


The Maternal and Child Health (MCH) handbook is an integrated home-based record (HBR) designed to record in a single document all the information regarding health services provided to a pregnant woman and her child. The MCH handbook has the potential to support continuity of care which is key to strengthening maternal, newborn and child health. However, there is a lack of an integrated system to manage the health of pregnant women and young children on an ongoing basis in Angola. Thus, the Angolan Ministry of Health is partnering with the Japan International Cooperation Agency to build the capacity of healthcare providers through trainings and implementation of the MCH handbook to improve service utilisation. In this study, we will estimate the impact of an intervention package including distribution of MCH handbook and its supplementary interventions to women, on the utilisation of services provided at healthcare facilities from pregnancy through the postnatal and early childhood period.
METHODS


This study is a cluster randomised controlled trial involving public healthcare facilities across all the municipalities located in Benguela Province, Angola. All women who go to participating healthcare facilities and with confirmed pregnancy around the beginning of the trial period will be included in the study. Women will be randomised according to the municipality where their primary maternity and/or childcare services are located. The intervention package will consist of MCH handbook distribution at all public healthcare facilities, MCH handbook utilisation training for healthcare providers and community mobilisation for women on the use of the MCH handbook. The intervention will be administered to all women in the intervention arm while those in the control arm will continue the traditional use of two stand-alone HBRs. The primary outcome measure for this study is to compare the proportion of women who achieve a complete continuum of care in both study arms.
DISCUSSION


The findings from the study are expected to form a basis for revising the current trial version of the Angola MCH handbook and provide a framework for policy guiding nationwide scale-up and distribution of the MCH handbook.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN20510127 . Registered on 4 June 2019.",2020,"The primary outcome measure for this study is to compare the proportion of women who achieve a complete continuum of care in both study arms.
","['All women who go to participating healthcare facilities and with confirmed pregnancy around the beginning of the trial period will be included in the study', 'pregnant women and young children']","['Maternal and Child Health handbook', 'MCH handbook utilisation training']",['proportion of women who achieve a complete continuum of care'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033010', 'cui_str': 'Pregnancy confirmed'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]",,0.0935833,"The primary outcome measure for this study is to compare the proportion of women who achieve a complete continuum of care in both study arms.
","[{'ForeName': 'Olukunmi Omobolanle', 'Initials': 'OO', 'LastName': 'Balogun', 'Affiliation': 'National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Caroline Kaori', 'Initials': 'CK', 'LastName': 'Tomo', 'Affiliation': 'National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Mochida', 'Affiliation': 'TA Networking Corp., Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Mikami', 'Affiliation': 'National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Henda', 'Initials': 'H', 'LastName': 'da Rosa Vasconcelos', 'Affiliation': 'National Directorate of Public Health, Luanda, Angola.'}, {'ForeName': 'Isilda', 'Initials': 'I', 'LastName': 'Neves', 'Affiliation': 'National Directorate of Public Health, Luanda, Angola.'}, {'ForeName': 'Hisakazu', 'Initials': 'H', 'LastName': 'Hiraoka', 'Affiliation': 'Japan International Cooperation Agency, Tokyo, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Aiga', 'Affiliation': 'Japan International Cooperation Agency, Tokyo, Japan.'}, {'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Mori', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Takehara', 'Affiliation': 'National Center for Child Health and Development, Tokyo, Japan. takehara-k@ncchd.go.jp.'}]",Trials,['10.1186/s13063-020-04664-w']
2126,32838813,A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan.,"BACKGROUND


Acute gastroenteritis is a leading cause of emergency department visits and hospitalizations among children in North America. Oral-rehydration therapy is recommended for children with mild-to-moderate dehydration, but children who present with vomiting are frequently offered intravenous rehydration in the emergency department (ED). Recent studies have demonstrated that the anti-emetic ondansetron can reduce vomiting, intravenous rehydration, and hospitalization when administered in the ED to children with dehydration. However, there is little evidence of additional benefit from prescribing ondansetron beyond the initial ED dose. Moreover, repeat dosing may increase the frequency of diarrhea. Despite the lack of evidence and potential adverse side effects, many physicians across North America provide multiple doses of ondansetron to be taken following ED disposition. Thus, the Multi-Dose Oral Ondansetron for Pediatric Gastroenteritis (DOSE-AGE) trial will evaluate the effectiveness of prescribing multiple doses of ondansetron to treat acute gastroenteritis-associated vomiting. This article specifies the statistical analysis plan (SAP) for the DOSE-AGE trial and was submitted before the outcomes of the study were available for analysis.
METHODS/DESIGN


The DOSE-AGE study is a phase III, 6-center, placebo-controlled, double-blind, parallel design randomized controlled trial designed to determine whether participants who are prescribed multiple doses of oral ondansetron to administer, as needed, following their ED visit have a lower incidence of experiencing moderate-to-severe gastroenteritis, as measured by the Modified Vesikari Scale score, compared with a placebo. To assess safety, the DOSE-AGE trial will investigate the frequency and maximum number of diarrheal episodes following ED disposition, and the occurrence of palpitations, pre-syncope/syncope, chest pain, arrhythmias, and serious adverse events. For the secondary outcomes, the DOSE-AGE trial will investigate the individual elements of the Modified Vesikari Scale score and caregiver satisfaction with the therapy.
DISCUSSION


The DOSE-AGE trial will provide evidence on the effectiveness of multiple doses of oral ondansetron, taken as needed, following an initial ED dose in children with acute gastroenteritis-associated vomiting. The data from the DOSE-AGE trial will be analyzed using this SAP. This will reduce the risk of producing data-driven results and bias in our reported outcomes. The DOSE-AGE study was registered on ClinicalTrials.gov on February 22, 2019.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03851835 . Registered on 22 February 2019.",2020,"Recent studies have demonstrated that the anti-emetic ondansetron can reduce vomiting, intravenous rehydration, and hospitalization when administered in the ED to children with dehydration.","['children with mild-to-moderate dehydration, but children who present with vomiting are frequently offered intravenous rehydration in the emergency department (ED', 'children with acute gastroenteritis-associated vomiting', 'children with dehydration', 'children in North America']","['Oral-rehydration therapy', 'placebo', 'oral ondansetron', 'Ondansetron', 'ondansetron']","['Modified Vesikari Scale score and caregiver satisfaction', 'vomiting, intravenous rehydration, and hospitalization', 'Modified Vesikari Scale score', 'occurrence of palpitations, pre-syncope/syncope, chest pain, arrhythmias, and serious adverse events', 'frequency of diarrhea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0029168', 'cui_str': 'Oral rehydration therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0700200', 'cui_str': 'Near syncope'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.280436,"Recent studies have demonstrated that the anti-emetic ondansetron can reduce vomiting, intravenous rehydration, and hospitalization when administered in the ED to children with dehydration.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada. anna.heath@sickkids.ca.'}, {'ForeName': 'Juan David', 'Initials': 'JD', 'LastName': 'Rios', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Pediatric Emergency Research Team, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Pechlivanoglou', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics, Edmonton, Alberta, Canada.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Hopkin', 'Affiliation': 'Institute of Health Economics, Edmonton, Alberta, Canada.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Plint', 'Affiliation': ""Division of Emergency Medicine, Children's Hospital of Eastern Ontario, Ottawa, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dixon', 'Affiliation': ""Stollery Children's Hospital, University of Alberta, Women's and Children's Health Research Institute, Edmonton, Canada.""}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Beer', 'Affiliation': ""Pediatrics/Pediatric Emergency Medicine, Department of Pediatrics and Child Health, Children's Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Joubert', 'Affiliation': ""Children's Hospital, Western University, London, Ontario, Canada.""}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04651-1']
2127,32838817,A randomized trial of aerobic exercise for major depression: examining neural indicators of reward and cognitive control as predictors and treatment targets.,"BACKGROUND


Aerobic exercise has demonstrated antidepressant efficacy among adults with major depression. There is a poor understanding of the neural mechanisms associated with these effects. Deficits in reward processing and cognitive control may be two candidate targets and predictors of treatment outcome to exercise in depression.
METHODS


Sixty-six young adults aged 20.23 years (s.d. = 2.39) with major depression were randomized to 8 weeks of moderate-intensity aerobic exercise (n = 35) or light stretching (n = 31). Depressive symptoms were assessed across the intervention to track symptom reduction. Reward processing [reward positivity (RewP)] and cognitive control [error-related negativity (ERN)] were assessed before and after the intervention using event-related brain potentials.
RESULTS


Compared to stretching, aerobic exercise resulted in greater symptom reduction (gs = 0.66). Aerobic exercise had no impact on the RewP (gav = 0.08) or ERN (gav = 0.21). In the aerobic exercise group, individuals with a larger pre-treatment RewP [odds ratio (OR) = 1.45] and increased baseline depressive symptom severity (OR = 1.18) were more likely to respond to an aerobic exercise program. Pre-treatment ERN did not predict response (OR = 0.74).
CONCLUSIONS


Aerobic exercise is effective in alleviating depressive symptoms in adults with major depression, particularly for those with increased depressive symptom severity and a larger RewP at baseline. Although aerobic exercise did not modify the RewP or ERN, there is preliminary support for the utility of the RewP in predicting who is most likely to respond to exercise as a treatment for depression.",2020,"Although aerobic exercise did not modify the RewP or ERN, there is preliminary support for the utility of the RewP in predicting who is most likely to respond to exercise as a treatment for depression.","['adults with major depression', 'Sixty-six young adults aged 20.23 years (s.d. ', 'major depression', '2.39) with major depression']","['Aerobic exercise', 'aerobic exercise', 'moderate-intensity aerobic exercise (n = 35) or light stretching', 'stretching, aerobic exercise']","['greater symptom reduction', 'Reward processing [reward positivity (RewP)] and cognitive control [error-related negativity (ERN', 'antidepressant efficacy', 'baseline depressive symptom severity', 'depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",66.0,0.0746406,"Although aerobic exercise did not modify the RewP or ERN, there is preliminary support for the utility of the RewP in predicting who is most likely to respond to exercise as a treatment for depression.","[{'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Brush', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Bocchine', 'Affiliation': 'Department of Kinesiology and Health and Center of Alcohol & Substance Use Studies, Rutgers, The State University of New Jersey, Piscataway, NJ, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Ude', 'Affiliation': 'Department of Kinesiology and Health and Center of Alcohol & Substance Use Studies, Rutgers, The State University of New Jersey, Piscataway, NJ, USA.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Muniz', 'Affiliation': 'Department of Kinesiology and Health and Center of Alcohol & Substance Use Studies, Rutgers, The State University of New Jersey, Piscataway, NJ, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Foti', 'Affiliation': 'Department of Psychological Sciences, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Brandon L', 'Initials': 'BL', 'LastName': 'Alderman', 'Affiliation': 'Department of Kinesiology and Health and Center of Alcohol & Substance Use Studies, Rutgers, The State University of New Jersey, Piscataway, NJ, USA.'}]",Psychological medicine,['10.1017/S0033291720002573']
2128,32838982,"Pharmacokinetics of ketamine and its major metabolites norketamine, hydroxynorketamine, and dehydronorketamine: a model-based analysis.","BACKGROUND


Recent studies show activity of ketamine metabolites, such as hydroxynorketamine, in producing rapid relief of depression-related symptoms and analgesia. To improve our understanding of the pharmacokinetics of ketamine and metabolites norketamine, dehydronorketamine, and hydroxynorketamine, we developed a population pharmacokinetic model of ketamine and metabolites after i.v. administration of racemic ketamine and the S-isomer (esketamine). Pharmacokinetic data were derived from an RCT on the efficacy of sodium nitroprusside (SNP) in reducing the psychotomimetic side-effects of ketamine in human volunteers.
METHODS


Three increasing i.v. doses of esketamine and racemic ketamine were administered to 20 healthy volunteers, and arterial plasma samples were obtained for measurement of ketamine and metabolites. Subjects were randomised to receive esketamine/SNP, esketamine/placebo, racemic ketamine/SNP, and racemic ketamine/placebo on four separate occasions. The time-plasma concentration data of ketamine and metabolites were analysed using a population compartmental model approach.
RESULTS


The pharmacokinetics of ketamine and metabolites were adequately described by a seven-compartment model with two ketamine, norketamine, and hydroxynorketamine compartments and one dehydronorketamine compartment with metabolic compartments in-between ketamine and norketamine, and norketamine and dehydronorketamine main compartments. Significant differences were found between S- and R-ketamine enantiomer pharmacokinetics, with up to 50% lower clearances for the R-enantiomers, irrespective of formulation. Whilst SNP had a significant effect on ketamine clearances, simulations showed only minor effects of SNP on total ketamine pharmacokinetics.
CONCLUSIONS


The model is of adequate quality for use in future pharmacokinetic and pharmacodynamic studies into the efficacy and side-effects of ketamine and metabolites.
CLINICAL TRIAL REGISTRATION


Dutch Cochrane Center 5359.",2020,"Significant differences were found between S- and R-ketamine enantiomer pharmacokinetics, with up to 50% lower clearances for the R-enantiomers, irrespective of formulation.","['human volunteers', '20 healthy volunteers']","['esketamine/SNP, esketamine/placebo, racemic ketamine/SNP, and racemic ketamine/placebo', 'ketamine and norketamine, and norketamine and dehydronorketamine main compartments', 'SNP', 'ketamine', 'hydroxynorketamine, and dehydronorketamine', 'ketamine and metabolites norketamine, dehydronorketamine, and hydroxynorketamine', 'esketamine and racemic ketamine', 'racemic ketamine and the S-isomer (esketamine', 'sodium nitroprusside (SNP']","['time-plasma concentration data of ketamine and metabolites', 'ketamine clearances']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C1143885', 'cui_str': 'dehydronorketamine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0022203', 'cui_str': 'Isomerism'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",20.0,0.0501973,"Significant differences were found between S- and R-ketamine enantiomer pharmacokinetics, with up to 50% lower clearances for the R-enantiomers, irrespective of formulation.","[{'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Kamp', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: j.kamp@lumc.nl.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Jonkman', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Aarts', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Olofsen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.067']
2129,32839029,Effects of Dexmedetomidine and ACE Genotype on Cardiovascular Response During the Decannulation Period of General Anesthesia in Patients With Essential Hypertension.,"PURPOSE


This study investigated the effects of dexmedetomidine on cardiovascular response during the decannulation period of general anesthesia in patients with different genotypes of angiotensin-converting enzyme (ACE) and essential hypertension.
METHODS


The present study enrolled patients with essential hypertension and American Society of Anesthesiologists class II or III who were scheduled to undergo abdominal surgery under general anesthesia. Patients were assigned to 1 of 6 groups according to ACE genotype, as detected by polymerase chain reaction-restriction fragment length polymorphism, as follows: DD; ID; II; and DD, ID, and II each with dexmedetomidine (Dex). Dexmedetomidine was intravenously infused at 0.5 μg/kg/h for 30 min before the end of surgery in groups DD (Dex), ID (Dex), and II(Dex). Anesthesia was induced and maintained by the same anesthetics in all patients. Systolic and diastolic blood pressure, heart rate (HR), ECG, and rate-pressure product were recorded before anesthesia induction; at 30 min before the end of surgery; at the end of surgery; and at 0, 1.5, 5, and 10 min after extubation.
FINDINGS


A total of 210 patients were enrolled (n = 35 per genotype). After extubation, systolic and diastolic blood pressure, HR, and RPP were increased markedly from baseline in groups DD, ID, and II; the increases were greater in groups DD and ID than in group II. No significant changes in blood pressure, HR, or RPP were found, and proper sedative was achieved in groups DD (Dex), ID (Dex), and II(Dex). The prevalences of cardiac arrhythmia were higher in groups DD and ID than in groups II, DD (Dex), ID (Dex), and II(Dex).
IMPLICATIONS


Patients essential hypertension and the ACE D allele had a strong hemodynamic response to tracheal extubation, on which dexmedetomidine was found to have both a prevention and treatment effect.",2020,"No significant changes in blood pressure, HR, or RPP were found, and proper sedative was achieved in groups DD (Dex), ID (Dex), and II(Dex).","['enrolled patients with essential hypertension and American Society of Anesthesiologists class II or III who were scheduled to undergo abdominal surgery under general anesthesia', '210 patients were enrolled (n\xa0=\xa035 per genotype', 'patients with different genotypes of angiotensin-converting enzyme (ACE) and essential hypertension', 'Patients With Essential Hypertension']","['Dexmedetomidine', 'dexmedetomidine (Dex', 'Dexmedetomidine and ACE Genotype', 'dexmedetomidine']","['Cardiovascular Response', 'systolic and diastolic blood pressure, HR, and RPP', 'prevalences of cardiac arrhythmia', 'Systolic and diastolic blood pressure, heart rate (HR), ECG, and rate-pressure product', 'cardiovascular response', 'blood pressure, HR, or RPP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",210.0,0.0247976,"No significant changes in blood pressure, HR, or RPP were found, and proper sedative was achieved in groups DD (Dex), ID (Dex), and II(Dex).","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Wei-Juan', 'Initials': 'WJ', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, Wuxi Hospital of Conventional Chinese Medicine, Wuxi, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China. Electronic address: wangjun19710930@126.com.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Zha', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Lishui, Nanjing, China.""}, {'ForeName': 'Mo-Qin', 'Initials': 'MQ', 'LastName': 'Shao', 'Affiliation': ""Electrocardiography, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Hui-Jun', 'Initials': 'HJ', 'LastName': 'Mu', 'Affiliation': ""Central Laboratory, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.012']
2130,32839043,A new randomized controlled trial on abdominal aortic aneurysm repair is needed.,,2020,,[],['abdominal aortic aneurysm repair'],[],[],"[{'cui': 'C0741152', 'cui_str': 'Repair of aneurysm of abdominal aorta'}]",[],,0.222781,,"[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Spanos', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Germany; German Aortic Center, Department of Vascular Medicine, University Heart Center, Hamburg, Germany. Electronic address: spanos.kon@gmail.com.'}, {'ForeName': 'Christian-Alexander', 'Initials': 'CA', 'LastName': 'Behrendt', 'Affiliation': 'German Aortic Center, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kouvelos', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Germany.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Giannoukas', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kölbel', 'Affiliation': 'German Aortic Center, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.06.102']
2131,32839108,"Response to the Letter to the editor ""Effectiveness of additional deep-water running for disability, lumbar pain intensity, and functional capacity in patients with chronic low back pain: A randomised controlled trial with 3-month follow-up"".",,2020,,['patients with chronic low back pain'],[],"['disability, lumbar pain intensity, and functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",,0.0935439,,"[{'ForeName': 'Rodrigo G S', 'Initials': 'RGS', 'LastName': 'Carvalho', 'Affiliation': 'Colegiado de Educação Física, Universidade Federal do Vale Do São Francisco, Petrolina, PE, Brazil. Electronic address: rodrigocarvalhofisio@gmail.com.'}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil. Electronic address: marianaf.fisio@gmail.com.'}, {'ForeName': 'Josilainne M', 'Initials': 'JM', 'LastName': 'Dias', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil; Medicine School, Universidade Estadual de Mato Grosso Do Sul, Campo Grande, MS, Brazil. Electronic address: lainne@hotmail.com.'}, {'ForeName': 'Mabel M', 'Initials': 'MM', 'LastName': 'Olkoski', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil; Department of Forest Engineering, Agroveterinary Sciences Center, Universidade do Estado de Santa Catarina, Lages, SC, Brazil. Electronic address: mabelolkoski@hotmail.com.'}, {'ForeName': 'Laís F', 'Initials': 'LF', 'LastName': 'Dela Bela', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil; Universidade Positive, Curitiba, PR, Brazil. Electronic address: laisdb@hotmail.com.'}, {'ForeName': 'Alexandre R M', 'Initials': 'ARM', 'LastName': 'Pelegrinelli', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil; Laboratory of Applied Biomechanics, Universidade Estadual de Londrina, Londrina, PR, Brazil. Electronic address: alexandrepelegrinelli@hotmail.com.'}, {'ForeName': 'Maria S T', 'Initials': 'MST', 'LastName': 'Barreto', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil. Electronic address: simone_barreto_@hotmail.com.'}, {'ForeName': 'Renata R', 'Initials': 'RR', 'LastName': 'Campos', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil. Electronic address: rehdecampos@hotmail.com.'}, {'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Guenka', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil. Electronic address: guenkaleandro@gmail.com.'}, {'ForeName': 'Ligia M', 'Initials': 'LM', 'LastName': 'Facci', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil. Electronic address: ligiafacci@hotmail.com.'}, {'ForeName': 'Jefferson R', 'Initials': 'JR', 'LastName': 'Cardoso', 'Affiliation': 'Laboratory of Biomechanics and Clinical Epidemiology, PAIFIT Research Group, Universidade Estadual de Londrina, Londrina, PR, Brazil. Electronic address: jeffcar@uel.br.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102228']
2132,32839125,Nurse Decision-making for Suspected Urinary Tract Infections in Nursing Homes: Potential Targets to Reduce Antibiotic Overuse.,"OBJECTIVES


To determine what information is most important to registered nurses' (RNs) decisions to call clinicians about suspected urinary tract infections (UTIs) in nursing home residents.
DESIGN


Web-based discrete choice experiment with 19 clinical scenarios.
SETTING AND PARTICIPANTS


Online survey with a convenience sample of RNs (N = 881) recruited from a health care research panel.
METHODS


Clinical scenarios used information from 10 categories of resident characteristics: UTI risk, resident type, functional status, mental status, lower urinary tract status, body temperature, physical examination, urinalysis, antibiotic request, and goals of care. Participants were randomized into 2 deliberation conditions (self-paced, n = 437 and forced deliberation, n = 444). The degree to which evidence- and non-evidence-based information was important to decision-making was estimated using unconditional multinomial logistic regression.
RESULTS


For all nurses (22.8%) and the self-paced group (24.1%), lower urinary tract status had the highest importance scores for the decision to call a clinician about a suspected UTI. For the forced-deliberation group, body temperature was most important (23.7%), and lower urinary tract status was less important (21%, P = .001). The information associated with the highest odds of an RN calling about a suspected UTI was painful or difficult urination [odds ratio (OR) 4.85, 95% confidence interval (CI) 4.16-5.65], obvious blood in urine (OR 4.66, 95% CI 3.99-5.44), and temperature at 101.5° (OR 3.80, 95% CI 3.28-4.42). For the self-paced group, painful or difficult urination (OR 5.65, 95% CI 4.53-7.04) had the highest odds, whereas obvious blood in urine (OR 4.39, 95% CI 3.53-5.47) had highest odds for the forced-deliberation group.
CONCLUSIONS AND IMPLICATIONS


This study highlighted the importance of specific resident characteristics in nurse decision-making about suspected UTIs. Future antimicrobial stewardship efforts should aim to not only improve the previously studied overprescribing practices of clinicians, but to improve nurses' assessment of signs and symptoms of potential infections and how they weigh resident information.",2020,"For the self-paced group, painful or difficult urination (OR 5.65, 95% CI 4.53-7.04) had the highest odds, whereas obvious blood in urine (OR 4.39, 95% CI 3.53-5.47) had highest odds for the forced-deliberation group.
","['Clinical scenarios used information from 10 categories of resident characteristics', 'Nursing Homes', 'Online survey with a convenience sample of RNs ', 'N\xa0=\xa0881) recruited from a health care research panel']",[],"['UTI risk, resident type, functional status, mental status, lower urinary tract status, body temperature, physical examination, urinalysis, antibiotic request, and goals of care', 'body temperature', 'obvious blood in urine', 'urinary tract status', 'painful or difficult urination']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0018757', 'cui_str': 'Research, Health Services'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",[],"[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}]",881.0,0.0667225,"For the self-paced group, painful or difficult urination (OR 5.65, 95% CI 4.53-7.04) had the highest odds, whereas obvious blood in urine (OR 4.39, 95% CI 3.53-5.47) had highest odds for the forced-deliberation group.
","[{'ForeName': 'Anna Song', 'Initials': 'AS', 'LastName': 'Beeber', 'Affiliation': 'School of Nursing, University of North Carolina, Chapel Hill, NC; The Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC. Electronic address: asbeeber@email.unc.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Kistler', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC; Department of Family Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC; School of Social Work, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Dictus', 'Affiliation': 'School of Nursing, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Farel', 'Affiliation': 'Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Chrzan', 'Affiliation': 'Sawtooth Analytics, Chesterton, IN.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Boyton-Hansen', 'Affiliation': 'School of Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pignone', 'Affiliation': 'School of Medicine, University of Texas, Austin, TX.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC; Department of Family Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.06.053']
2133,32839137,Pharmacist-led motivational interviewing for diabetes medication adherence in a worksite wellness program.,"OBJECTIVE


The primary objective was to evaluate the impact of a pharmacist-delivered motivational interviewing (MI) intervention for diabetes medication adherence; the secondary objectives were to assess the changes in clinical outcomes and health-related quality of life (HRQoL).
METHODS


A quasi-experimental intervention study was conducted with baseline, postintervention, and follow-up data collections. The study duration was 6 months. Pharmacists trained in MI delivered 3 face-to-face encounters using MI-based semistructured conversation tools to address barriers or challenges to medication adherence. A diabetes worksite wellness program (WWP) at a 350-bed regional hospital in the southeastern United States was the setting, and the study participants were WWP employees or dependents (with type 1 diabetes or type 2 diabetes). The primary outcome was a change in self-reported diabetes medication adherence; the secondary outcomes included the changes in clinical indicators (glycated hemoglobin [HbA1c], blood pressure, and depressive symptoms), and HRQoL. The measures included the Medometer, Summary of Diabetes Self-Care Activities-Medication Subscale (SDSCA-MS), Audit of Diabetes-Dependent QoL (ADDQoL-19), and the Short Form-12 (SF-12) health survey.
RESULTS


Fifty-three WWP participants enrolled, and 36 completed the full intervention protocol. Medication adherence (through the Medometer) demonstrated statistically significant improvement after the intervention (P = 0.010); the SDSCA-MS score improved, but was not statistically significant. The change in diastolic blood pressure was statistically significant (P = 0.034), but the changes in HbA1c, systolic blood pressure, presence of depressive symptoms, and ADDQoL-19 were not statistically significant. The SF-12 physical component summary (PCS) and mental component summary (MCS) scores were statistically significant: PCS, P = 0.003, and MCS, P = 0.025.
CONCLUSION


The findings from this pilot study support the effectiveness of a pharmacist-delivered, semistructured MI-based intervention for medication adherence in persons with diabetes in a hospital-based WWP. Pharmacists can support patients' behavior change using MI communication skills to explore salient barriers to medication adherence and to facilitate goal setting to overcome these in encounters aimed at shared clinical and behavioral decision-making.",2020,"Medication adherence (through the Medometer) demonstrated statistically significant improvement after the intervention (P = 0.010); the SDSCA-MS score improved, but was not statistically significant.","['Fifty-three WWP participants enrolled, and 36 completed the full intervention protocol', 'persons with diabetes in a hospital-based WWP', 'A diabetes worksite wellness program (WWP) at a 350-bed regional hospital in the southeastern United States was the setting, and the study participants were WWP employees or dependents (with type 1 diabetes or type 2 diabetes', 'diabetes medication adherence']","['pharmacist-delivered motivational interviewing (MI) intervention', 'Pharmacist-led motivational interviewing', 'pharmacist-delivered, semistructured MI-based intervention']","['Medication adherence', 'diastolic blood pressure', 'clinical outcomes and health-related quality of life (HRQoL', 'Medometer, Summary of Diabetes Self-Care Activities-Medication Subscale (SDSCA-MS), Audit of Diabetes-Dependent QoL (ADDQoL-19), and the Short Form-12 (SF-12) health survey', 'change in self-reported diabetes medication adherence', 'SF-12 physical component summary (PCS) and mental component summary (MCS) scores', 'changes in HbA1c, systolic blood pressure, presence of depressive symptoms, and ADDQoL-19', 'changes in clinical indicators (glycated hemoglobin [HbA1c], blood pressure, and depressive symptoms), and HRQoL', 'SDSCA-MS score']","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",53.0,0.0436153,"Medication adherence (through the Medometer) demonstrated statistically significant improvement after the intervention (P = 0.010); the SDSCA-MS score improved, but was not statistically significant.","[{'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Ekong', 'Affiliation': ''}, {'ForeName': 'Chiahung', 'Initials': 'C', 'LastName': 'Chou', 'Affiliation': ''}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Lakin', 'Affiliation': ''}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Hardin', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Caralise', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kavookjian', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.07.025']
2134,32839158,Correction: Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.,,2020,,['heterosexual couples'],"['HPV vaccination ', 'HPV vaccination']",[],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.0545783,,[],BMJ open,['10.1136/bmjopen-2020-039383corr1']
2135,32839161,Improving pain management in childhood acute otitis media in general practice: a cluster randomised controlled trial of a GP-targeted educational intervention.,"BACKGROUND


Pain management in acute otitis media (AOM) is often suboptimal, potentially leading to unnecessary discomfort, GP reconsultation, and antibiotic prescribing.
AIM


To assess the effectiveness of a GP-targeted educational intervention to improve pain management in children with AOM.
DESIGN AND SETTING


Pragmatic, cluster randomised controlled trial (RCT). GPs in 37 practices (intervention  n  = 19; control  n  = 18) across the Netherlands recruited 224 children with GP-confirmed AOM and ear pain (intervention  n  = 94; control  n  = 130) between February 2015 and May 2018.
METHOD


GPs in practices allocated to the intervention group were trained (online and face-to-face) to discuss pain management with parents using an information leaflet, and prompted to prescribe weight-appropriate dosed paracetamol. Ibuprofen was additionally prescribed if pain control was still insufficient. GPs in the control group provided usual care.
RESULTS


Mean ear pain scores over the first 3 days were similar between groups (4.66 versus 4.36; adjusted mean difference = -0.05; 95% confidence intervals [CI] = -0.93 to 0.83), whereas analgesic use, in particular ibuprofen, was higher in the intervention group. The total number of antibiotic prescriptions during the 28-day follow-up was similar (mean rate 0.43 versus 0.47; adjusted rate ratio [aRR] 0.97; 95% CI = 0.68 to 1.38). Parents of children in the intervention group were more likely to reconsult for AOM-related complaints (mean rate 0.70 versus 0.41; aRR 1.73; 95% CI = 1.14 to 2.62).
CONCLUSION


An intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit. GPs are advised to carefully weigh the potential benefits of ibuprofen against its possible harms.",2020,"An intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit.","['childhood acute otitis media in general practice', 'acute otitis media (AOM', '37 practices (intervention  n  = 19; control  n  = 18) across the Netherlands recruited 224 children with GP-confirmed AOM and ear pain (intervention  n  = 94; control  n  = 130) between February 2015 and May 2018', 'children with AOM']","['Ibuprofen', 'intervention group were trained (online and face-to-face) to discuss pain management with parents using an information leaflet, and prompted to prescribe weight-appropriate dosed paracetamol', 'GP-targeted educational intervention', 'ibuprofen']","['AOM-related complaints', 'Mean ear pain scores', 'pain management', 'total number of antibiotic prescriptions']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",224.0,0.136145,"An intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit.","[{'ForeName': 'Rick T', 'Initials': 'RT', 'LastName': 'van Uum', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Venekamp', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas Pa', 'Initials': 'NP', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Alies', 'Initials': 'A', 'LastName': 'Sjoukes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Alma C', 'Initials': 'AC', 'LastName': 'van de Pol', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Anne Gm', 'Initials': 'AG', 'LastName': 'Schilder', 'Affiliation': 'University College London; National Institute for Health Research research professor evidENT, Ear Institute, University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Roger Amj', 'Initials': 'RA', 'LastName': 'Damoiseaux', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X712589']
2136,32839200,"Metagenomics analysis of gut microbiota in response to diet intervention and gestational diabetes in overweight and obese women: a randomised, double-blind, placebo-controlled clinical trial.","OBJECTIVE


Gut microbiota and diet are known to contribute to human metabolism. We investigated whether the metagenomic gut microbiota composition and function changes over pregnancy are related to gestational diabetes mellitus (GDM) and can be modified by dietary supplements, fish oil and/or probiotics.
DESIGN


The gut microbiota of 270 overweight/obese women participating in a mother-infant clinical study were analysed with metagenomics approach in early (mean gestational weeks 13.9) and late (gestational weeks 35.2) pregnancy. GDM was diagnosed with a 2 hour 75 g oral glucose tolerance test.
RESULTS


Unlike women with GDM, women without GDM manifested changes in relative abundance of bacterial species over the pregnancy, particularly those receiving the fish oil + probiotics combination. The specific bacterial species or function did not predict the onset of GDM nor did it differ according to GDM status, except for the higher abundance of  Ruminococcus obeum  in late pregnancy in the combination group in women with GDM compared with women without GDM. In the combination group, weak decreases over the pregnancy were observed in basic bacterial housekeeping functions.
CONCLUSIONS


The specific gut microbiota species do not contribute to GDM in overweight/obese women. Nevertheless, the GDM status may disturb maternal gut microbiota flexibility and thus limit the capacity of women with GDM to respond to diet, as evidenced by alterations in gut microbiota observed only in women without GDM. These findings may be important when considering the metabolic complications during pregnancy, but further studies with larger populations are called for to verify the findings.",2020,"The specific bacterial species or function did not predict the onset of GDM nor did it differ according to GDM status, except for the higher abundance of  Ruminococcus obeum  in late pregnancy in the combination group in women with GDM compared with women without GDM.","['gestational diabetes in overweight and obese women', '270 overweight/obese women participating in a mother-infant clinical study were analysed with metagenomics approach in early (mean gestational weeks 13.9) and late (gestational weeks 35.2) pregnancy', 'overweight/obese women']","['placebo', 'GDM', 'diet intervention']",['relative abundance of bacterial species'],"[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}]",270.0,0.045079,"The specific bacterial species or function did not predict the onset of GDM nor did it differ according to GDM status, except for the higher abundance of  Ruminococcus obeum  in late pregnancy in the combination group in women with GDM compared with women without GDM.","[{'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Mokkala', 'Affiliation': 'Institute of Biomedicine, Research Centre for Integrative Physiology and Pharmacology, University of Turku, Turku, Finland Kati.Mokkala@utu.fi.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Paulin', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Houttu', 'Affiliation': 'Institute of Biomedicine, Research Centre for Integrative Physiology and Pharmacology, University of Turku, Turku, Finland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Koivuniemi', 'Affiliation': 'Institute of Biomedicine, Research Centre for Integrative Physiology and Pharmacology, University of Turku, Turku, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Pellonperä', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Pietilä', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tertti', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Elo', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Laitinen', 'Affiliation': 'Institute of Biomedicine, Research Centre for Integrative Physiology and Pharmacology, University of Turku, Turku, Finland.'}]",Gut,['10.1136/gutjnl-2020-321643']
2137,32839221,"A five-in-one first-in-human study to assess safety, tolerability, and pharmacokinetics of RO7049389, an inhibitor of hepatitis B virus capsid assembly, after single and multiple ascending doses in healthy participants.","RO7049389, an inhibitor of hepatitis B virus (HBV) capsid assembly, is being developed for the treatment of patients with chronic HBV infection. The objectives of this first-in-human study are to assess the safety, tolerability, pharmacokinetics (PK), food effect, inhibitory effect on CYP3A, and effect on QT of RO7049389 in healthy participants. Five components, single ascending doses (SAD) cohorts, multiple ascending doses (MAD) cohorts, food effect assessment, drug-drug interaction assessment, and concentration-QT analysis were integrated in one study (five-in-one). Participants randomly received a single dose of 150-2500 mg RO7049389 or placebo in SAD cohorts (n = 41), or multiple doses of 200-800 mg RO7049389 or placebo in MAD cohorts (n = 42). A single doses of 450 mg RO7049389 was administrated under fasted and fed condition. The micro-dose of midazolam was administrated before and after multiple dosing of RO7049389. Safety and tolerability were monitored throughout the study. Serial blood and urine samples were collected for the PK analysis. RO7049389 was safe and well tolerated in healthy participants. Absorption and elimination of RO7049389 occurred rapidly in plasma with minimal recovery in urine. Greater than dose-proportional increases in plasma exposure were observed. Exposure of RO7049389 (450 mg) increased by ∼2 fold when administered with a high fat meal. The inhibition effect of RO7049389 on CYP3A was weak (< 20%). No effect on QT interval was observed up to a single dose of 2500 mg. RO7049389 displayed a favorable safety, tolerability and PK profile suitable for further clinical development.",2020,The inhibition effect of RO7049389 on CYP3A was weak (< 20%).,"['patients with chronic HBV infection', 'healthy participants']","['RO7049389 or placebo', 'midazolam']","['plasma exposure', 'Serial blood and urine samples', 'Safety and tolerability', 'safety, tolerability, and pharmacokinetics', 'QT interval', 'safe and well tolerated', 'favorable safety, tolerability', 'concentration-QT analysis', 'safety, tolerability, pharmacokinetics (PK), food effect, inhibitory effect on CYP3A']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}]",,0.0647484,The inhibition effect of RO7049389 on CYP3A was weak (< 20%).,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwabe', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Triyatni', 'Affiliation': 'Early Development Safety, Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Biostatistics, Roche Pharma Product Development Shanghai, Shanghai, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Bo', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China. yuyan.jin@roche.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01323-20']
2138,32839253,Analgesic efficacy of infiltration between the popliteal artery and capsule of the knee (iPACK) block added to local infiltration analgesia and continuous adductor canal block after total knee arthroplasty: a randomized clinical trial.,"BACKGROUND


A combination of motor-sparing analgesia with local infiltration analgesia (LIA) and continuous adductor canal block (CACB) may improve postoperative pain and functional recovery for total knee arthroplasty (TKA). We hypothesized that the addition of a novel technique for posterior knee block, known as the infiltration between the popliteal artery and capsule of the knee (iPACK) block, to LIA with CACB would reduce opioid requirements.
METHODS


In this double-blinded randomized controlled trial, 72 patients were assigned to receive either LIA with CACB (LIA+CACB group) or iPACK block with LIA and CACB (iPACK+LIA+CACB group). The primary outcome was cumulative postoperative intravenous morphine consumption within 24 hours. The secondary outcomes included numerical rating scale pain scores, incidence of posterior knee pain, performance test results, patient satisfaction, length of stay, and adverse events.
RESULTS


Morphine consumption within 24 hours postoperatively showed no significant intergroup difference (LIA+CACB; 1.31±1.85 mg vs iPACK+LIA+CACB; 0.61±1.25 mg, p=0.08). There were no clinically significant differences in the overall pain scores between the groups. The lower Timed Up and Go test scores on postoperative days 1 and 2, along with a shorter duration of hospitalization, were found in the iPACK+LIA+CACB group (p<0.05).
CONCLUSION


The addition of an iPACK block to the LIA and CACB does not reduce the postoperative opioid consumption nor improve analgesia. However, it may improve immediate functional performance and reduce the length of hospitalization after TKA.
TRIAL REGISTRATION NUMBER


TCTR20180702001.",2020,The addition of an iPACK block to the LIA and CACB does not reduce the postoperative opioid consumption nor improve analgesia.,"['total knee arthroplasty (TKA', '72 patients', 'total knee arthroplasty']","['motor-sparing analgesia with local infiltration analgesia (LIA) and continuous adductor canal block (CACB', 'local infiltration analgesia and continuous adductor canal block', 'iPACK+LIA+CACB', 'LIA with CACB (LIA+CACB group) or iPACK block with LIA and CACB (iPACK+LIA+CACB group']","['cumulative postoperative intravenous morphine consumption', 'immediate functional performance', 'postoperative opioid consumption nor improve analgesia', 'numerical rating scale pain scores, incidence of posterior knee pain, performance test results, patient satisfaction, length of stay, and adverse events', 'overall pain scores', 'Analgesic efficacy']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",72.0,0.504575,The addition of an iPACK block to the LIA and CACB does not reduce the postoperative opioid consumption nor improve analgesia.,"[{'ForeName': 'Chutikant', 'Initials': 'C', 'LastName': 'Vichainarong', 'Affiliation': 'Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wirinaree', 'Initials': 'W', 'LastName': 'Kampitak', 'Affiliation': 'Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand nutong127@yahoo.com.'}, {'ForeName': 'Aree', 'Initials': 'A', 'LastName': 'Tanavalee', 'Affiliation': 'Orthopedics, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Srihatach', 'Initials': 'S', 'LastName': 'Ngarmukos', 'Affiliation': 'Orthopedics, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nattaporn', 'Initials': 'N', 'LastName': 'Songborassamee', 'Affiliation': 'Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101396']
2139,32839468,Hydrocortisone decreases metacognitive efficiency independent of perceived stress.,"It is well established that acute stress produces negative effects on high level cognitive functions. However, these effects could be due to the physiological components of the stress response (among which cortisol secretion is prominent), to its psychological concomitants (the thoughts generated by the stressor) or to any combination of those. Our study shows for the first time that the typical cortisol response to stress is sufficient to impair metacognition, that is the ability to monitor one's own performance in a task. In a pharmacological protocol, we administered either 20 mg hydrocortisone or placebo to 46 male participants, and measured their subjective perception of stress, their performance in a perceptual task, and their metacognitive ability. We found that hydrocortisone selectively impaired metacognitive ability, without affecting task performance or creating a subjective state of stress. In other words, the single physiological response of stress produces a net effect on metacognition. These results inform our basic understanding of the physiological bases of metacognition. They are also relevant for applied or clinical research about situations involving stress, anxiety, depression, or simply cortisol use.",2020,"We found that hydrocortisone selectively impaired metacognitive ability, without affecting task performance or creating a subjective state of stress.",['46 male participants'],"['hydrocortisone', 'hydrocortisone or placebo', 'Hydrocortisone']","['metacognitive efficiency', 'metacognitive ability']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",46.0,0.0210605,"We found that hydrocortisone selectively impaired metacognitive ability, without affecting task performance or creating a subjective state of stress.","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Reyes', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile.'}, {'ForeName': 'Anastassia', 'Initials': 'A', 'LastName': 'Vivanco-Carlevari', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Medina', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Manosalva', 'Affiliation': 'Institute of Pharmacy, Faculty of Sciences, Universidad Austral de Chile (UACh), Valdivia, Chile.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'de Gardelle', 'Affiliation': 'Paris School of Economics and CNRS, Paris, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Sackur', 'Affiliation': ""Laboratoire de Sciences Cognitives Et Psycholinguistique (EHESS/CNRS/ENS), PSL Research University, École Normale Supérieure, 29 rue d'Ulm, 75005, Paris, France. jerome.sackur@gmail.com.""}, {'ForeName': 'Jaime R', 'Initials': 'JR', 'LastName': 'Silva', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile. jaimesilva@udd.cl.'}]",Scientific reports,['10.1038/s41598-020-71061-3']
2140,32839527,Minocycline differentially modulates human spatial memory systems.,"Microglia play a critical role in many processes fundamental to learning and memory in health and are implicated in Alzheimer's pathogenesis. Minocycline, a centrally-penetrant tetracycline antibiotic, inhibits microglial activation and enhances long-term potentiation, synaptic plasticity, neurogenesis and hippocampal-dependent spatial memory in rodents, leading to clinical trials in human neurodegenerative diseases. However, the effects of minocycline on human memory have not previously been investigated. Utilising a double-blind, randomised crossover study design, we recruited 20 healthy male participants (mean 24.6 ± 5.0 years) who were each tested in two experimental sessions: once after 3 days of Minocycline 150 mg (twice daily), and once 3 days of placebo (identical administration). During each session, all completed an fMRI task designed to tap boundary- and landmark-based navigation (thought to rely on hippocampal and striatal learning mechanisms respectively). Given the rodent literature, we hypothesised that minocycline would selectively modulate hippocampal learning. In line with this, minocycline biased use of boundary- compared to landmark-based information (t 980  = 3.140, p = 0.002). However, though this marginally improved performance for boundary-based objects (t 980  = 1.972, p = 0.049), it was outweighed by impaired landmark-based navigation (t 980  = 6.374, p < 0.001) resulting in an overall performance decrease (t 980  = 3.295, p = 0.001). Furthermore, against expectations, minocycline significantly reduced activity during memory encoding in the right caudate (t 977  = 2.992, p = 0.003) and five other cortical regions, with no significant effect in the hippocampus. In summary, minocycline impaired human spatial memory performance, likely through disruption of striatal processing resulting in greater biasing towards reliance on boundary-based navigation.",2020,"However, though this marginally improved performance for boundary-based objects (t 980  = 1.972, p = 0.049), it was outweighed by impaired landmark-based navigation (t 980  = 6.374, p < 0.001) resulting in an overall performance decrease (t 980  = 3.295, p = 0.001).",['20 healthy male participants (mean 24.6\u2009±\u20095.0 years'],"['placebo', 'minocycline', 'Minocycline', 'fMRI task designed to tap boundary- and landmark-based navigation']","['human spatial memory systems', 'overall performance decrease', 'human spatial memory performance', 'activity during memory encoding in the right caudate', 'hippocampal learning']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0814087', 'cui_str': 'Spatial Memory'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",20.0,0.177706,"However, though this marginally improved performance for boundary-based objects (t 980  = 1.972, p = 0.049), it was outweighed by impaired landmark-based navigation (t 980  = 6.374, p < 0.001) resulting in an overall performance decrease (t 980  = 3.295, p = 0.001).","[{'ForeName': 'Sam C', 'Initials': 'SC', 'LastName': 'Berens', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, BN1 9QH, UK.'}, {'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Bird', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, BN1 9QH, UK.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Harrison', 'Affiliation': 'Cardiff University Brain Research Imaging Centre, Cardiff University, Cardiff, CF24 4HQ, UK. HarrisonN4@cardiff.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00811-8']
2141,32839714,Effects of the endodontic access cavity on apical debris extrusion during root canal preparation using different single-file systems.,"Objectives


This study was conducted to evaluate the effects of traditional and contracted endodontic cavity (TEC and CEC) preparation with the use of Reciproc Blue (RPC B) and One Curve (OC) single-file systems on the amount of apical debris extrusion in mandibular first molar root canals.
Materials and Methods


Eighty extracted mandibular first molar teeth were randomly assigned to 4 groups ( n  = 20) according to the endodontic access cavity shape and the single file system used for root canal preparation (reciprocating motion with the RCP B and rotary motion with the OC): TEC-RPC B, TEC-OC, CEC-RPC B, and CEC-OC. The apically extruded debris during preparation was collected in Eppendorf tubes. The amount of extruded debris was quantified by subtracting the weight of the empty tubes from the weight of the Eppendorf tubes containing the debris. Data were analyzed using 1-way analysis of variance with the Tukey  post hoc  test. The level of significance was set at  p  < 0.05.
Results


The CEC-RPC B group showed more apical debris extrusion than the TEC-OC and CEC-OC groups ( p  < 0.05). There were no statistically significant differences in the amount of apical debris extrusion among the TEC-OC, CEC-OC, and TEC-RPC B groups.
Conclusions


RPC B caused more apical debris extrusion in the CEC groups than did the OC single-file system. Therefore, it is suggested that the RPC B file should be used carefully in teeth with a CEC.",2020,"There were no statistically significant differences in the amount of apical debris extrusion among the TEC-OC, CEC-OC, and TEC-RPC B groups.
","['Materials and Methods\n\n\nEighty extracted mandibular first molar teeth', 'mandibular first molar root canals']","['endodontic access cavity shape and the single file system used for root canal preparation (reciprocating motion with the RCP B and rotary motion with the OC', 'traditional and contracted endodontic cavity (TEC and CEC', 'Reciproc Blue (RPC B) and One Curve (OC) single-file systems']","['TEC-RPC B, TEC-OC, CEC-RPC B, and CEC-OC', 'apical debris extrusion', 'amount of apical debris extrusion']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0932487', 'cui_str': 'Structure of first molar tooth'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0229951', 'cui_str': 'Thymic epithelial cell'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}]","[{'cui': 'C0229951', 'cui_str': 'Thymic epithelial cell'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}]",80.0,0.0186822,"There were no statistically significant differences in the amount of apical debris extrusion among the TEC-OC, CEC-OC, and TEC-RPC B groups.
","[{'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Tüfenkçi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Koray', 'Initials': 'K', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Adigüzel', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University, Hatay, Turkey.'}]",Restorative dentistry & endodontics,['10.5395/rde.2020.45.e33']
2142,32839717,Bonding of a resin-modified glass ionomer cement to dentin using universal adhesives.,"Objectives


This study aims to assess the effect of universal adhesives pretreatment on the bond strength of resin-modified glass ionomer cement to dentin.
Materials and Methods


Fifty caries-free human third molars were employed. The teeth were randomly assigned into five groups ( n  = 10) based on dentin surface pretreatments: Single Bond Universal (3M Oral Care), Gluma Bond Universal (Heraeus Kulzer), Prime&Bond Elect (Dentsply), Cavity Conditioner (GC) and control (no surface treatment). After Fuji II LC (GC) was bonded to the dentin surfaces, the specimens were stored for 7 days at 37°C. The specimens were segmented into microspecimens, and the microspecimens were subjugated to microtensile bond strength testing (1.0 mm/min). The modes of failure analyzed using a stereomicroscope and scanning electron microscopy. Data were statistically analyzed with one-way analysis of variance and Duncan tests ( p  = 0.05).
Results


The surface pretreatments with the universal adhesives and conditioner increased the bond strength of Fuji II LC to dentin ( p  < 0.05). Single Bond Universal and Gluma Bond Universal provided higher bond strength to Fuji II LC than Cavity Conditioner ( p  < 0.05). The bond strengths obtained from Prime&Bond Elect and Cavity Conditioner were not statistically different ( p  > 0.05).
Conclusions


The universal adhesives and polyacrylic acid conditioner could increase the bond strength of resin-modified glass ionomer cement (RMGIC) to dentin. The use of universal adhesives before the application of RMGIC may be more beneficial in improving bond strength.",2020,The surface pretreatments with the universal adhesives and conditioner increased the bond strength of Fuji II LC to dentin ( p  < 0.05).,[],"['dentin surface pretreatments: Single Bond Universal (3M Oral Care), Gluma Bond Universal (Heraeus Kulzer), Prime&Bond Elect (Dentsply), Cavity Conditioner (GC) and control (no surface treatment', 'Fuji II LC (GC']",['bond strength of Fuji II LC to dentin'],[],"[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0759863', 'cui_str': 'single bond'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0061452', 'cui_str': 'Gluma'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0752394', 'cui_str': 'cavity conditioner'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0213535', 'cui_str': 'Fuji II LC cement'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0213535', 'cui_str': 'Fuji II LC cement'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",50.0,0.0369676,The surface pretreatments with the universal adhesives and conditioner increased the bond strength of Fuji II LC to dentin ( p  < 0.05).,"[{'ForeName': 'Muhittin', 'Initials': 'M', 'LastName': 'Ugurlu', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Süleyman Demirel University, Isparta, Turkey.'}]",Restorative dentistry & endodontics,['10.5395/rde.2020.45.e36']
2143,32839719,Apical root canal cleaning after preparation with endodontic instruments: a randomized trial  in vivo  analysis.,"Objectives


This study aimed to evaluate vital pulp tissue removal from different endodontic instrumentation systems from root canal apical third  in vivo .
Materials and Methods


Thirty mandibular molars were selected and randomly divided into 2 test groups and one control group. Inclusion criteria were a positive response to cold sensibility test, curvature angle between 10 and 20 degrees, and curvature radius lower than 10 mm. Root canals prepared with Hero 642 system (size 45/0.02) ( n  = 10) and Reciproc R40 (size 40/0.06) ( n  = 10) and control ( n  = 10) without instrumentation. Canals were irrigated only with saline solution during root canal preparation. The apical third was evaluated considering the touched/untouched perimeter and area to evaluate the efficacy of root canal wall debridement. Statistical analysis used  t -test for comparisons.
Results


Untouched root canal at cross-section perimeter, the Hero 642 system showed 41.44% ± 5.62% and Reciproc R40 58.67% ± 12.39% without contact with instruments. Regarding the untouched area, Hero 642 system showed 22.78% ± 6.42% and Reciproc R40 34.35% ± 8.52%. Neither instrument achieved complete cross-sectional root canal debridement. Hero 642 system rotary taper 0.02 instruments achieved significant greater wall contact perimeter and area compared to reciprocate the Reciproc R40 taper 0.06 instrument.
Conclusions


Hero 642 achieved higher wall contact perimeter and area but, regardless of instrument size and taper, vital pulp during  in vivo  instrumentation is not entirely removed.",2020,"Hero 642 system rotary taper 0.02 instruments achieved significant greater wall contact perimeter and area compared to reciprocate the Reciproc R40 taper 0.06 instrument.
",['Materials and Methods\n\n\nThirty mandibular molars'],['Apical root canal cleaning'],"['complete cross-sectional root canal debridement', 'wall contact perimeter']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}]",,0.0763726,"Hero 642 system rotary taper 0.02 instruments achieved significant greater wall contact perimeter and area compared to reciprocate the Reciproc R40 taper 0.06 instrument.
","[{'ForeName': 'Volmir João', 'Initials': 'VJ', 'LastName': 'Fornari', 'Affiliation': 'Endodontic Division, Department of Restorative Dentistry, Piracicaba Dental School, Campinas State University (UNICAMP), Piracicaba, SP, Brazil.'}, {'ForeName': 'Mateus Silveira Martins', 'Initials': 'MSM', 'LastName': 'Hartmann', 'Affiliation': 'Endodontic Division, Department of Restorative Dentistry, Piracicaba Dental School, Campinas State University (UNICAMP), Piracicaba, SP, Brazil.'}, {'ForeName': 'José Roberto', 'Initials': 'JR', 'LastName': 'Vanni', 'Affiliation': 'Meridional Dental Studies Center (CEOM), Passo Fundo, RS, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Rodriguez', 'Affiliation': 'Pathology Institute of Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Marina Canali', 'Initials': 'MC', 'LastName': 'Langaro', 'Affiliation': 'Meridional Dental Studies Center (CEOM), Passo Fundo, RS, Brazil.'}, {'ForeName': 'Lauter Eston', 'Initials': 'LE', 'LastName': 'Pelepenko', 'Affiliation': 'Endodontic Division, Department of Restorative Dentistry, Piracicaba Dental School, Campinas State University (UNICAMP), Piracicaba, SP, Brazil.'}, {'ForeName': 'Alexandre Augusto', 'Initials': 'AA', 'LastName': 'Zaia', 'Affiliation': 'Endodontic Division, Department of Restorative Dentistry, Piracicaba Dental School, Campinas State University (UNICAMP), Piracicaba, SP, Brazil.'}]",Restorative dentistry & endodontics,['10.5395/rde.2020.45.e38']
2144,32839784,RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of people globally. Multiple vaccine candidates are under development, but no vaccine is currently available.
METHODS


Healthy adults 18-55 and 65-85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS-CoV-2 full-length spike. In each of 13 groups of 15 participants, 12 received vaccine and 3 received placebo. Groups were distinguished by vaccine candidate, age of participant, and vaccine dose level. Interim safety and immunogenicity data of BNT162b1 in younger adults have been reported previously from US and German trials. We now present additional safety and immunogenicity data from the US Phase 1 trial that supported selection of the vaccine candidate advanced to a pivotal Phase 2/3 safety and efficacy evaluation.
RESULTS


In both younger and older adults, the 2 vaccine candidates elicited similar dose-dependent SARS-CoV-2-neutralizing geometric mean titers (GMTs), comparable to or higher than the GMT of a panel of SARS-CoV-2 convalescent sera. BNT162b2 was associated with less systemic reactogenicity, particularly in older adults.
CONCLUSION


These results support selection of the BNT162b2 vaccine candidate for Phase 2/3 large-scale safety and efficacy evaluation, currently underway.",2020,"BNT162b2 was associated with less systemic reactogenicity, particularly in older adults.
","['younger adults', 'Healthy adults 18-55 and 65-85 years of age']","['placebo', 'placebo or either of 2 lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates', 'vaccine']",['systemic reactogenicity'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}]",,0.266351,"BNT162b2 was associated with less systemic reactogenicity, particularly in older adults.
","[{'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frenck', 'Affiliation': ''}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': ''}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': ''}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': ''}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': ''}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': ''}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Thompkins', 'Affiliation': ''}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': ''}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': ''}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': ''}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': ''}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Sahin', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2020.08.17.20176651']
2145,32839797,Effects of pomegranate peel extract and vitamin E on the inflammatory status and endothelial function in hemodialysis patients: a randomized controlled clinical trial.,"Inflammation and endothelial dysfunction are major problems in hemodialysis (HD) patients. This study assessed the effects of an 8 week administration of pomegranate peel extract (PPE) and vitamin E (Vit E) alone or in combination on the biomarkers of inflammation, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), and the biomarkers of endothelial function, including intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and P-selectin, in HD patients. In a randomized, double-blind, parallel, placebo-controlled trial, 100 HD patients were randomly divided into 4 equal groups: (a) PPE + Vit E, received 2 pomegranate tablets (each tablet contained 225 mg PPE, equal to 90 mg ellagic acid) + 1 Vit E soft gel (400 IU) daily, (b) PPE, received 2 pomegranate tablets + 1 Vit E placebo soft gel daily, (c) Vit E, received 1 Vit E soft gel + 2 pomegranate placebo tablets daily, and (d) placebo, received 2 pomegranate placebo tablets + 1 Vit E placebo soft gel daily. For group allocation, a stratified block randomization procedure based on sex, age, and HD duration was used. Each intervention product and its placebo had identical shape, color, size, and packaging. Consumption of PPE + Vit E significantly reduced the serum CRP level (mean change: -7.12 ± 4.59 mg l-1, P < 0.001) compared to other groups, while reduced levels of IL-6 (mean change: -2.19 ± 2.33 pg ml-1, P < 0.001), TNF-α (mean change: -2.41 ± 3.21 pg ml-1, P = 0.008), ICAM-1 (mean change: -64.2 ± 111.0 ng ml-1, P = 0.017), and VCAM-1 (mean change: -117.7 ± 177.1 ng ml-1, P = 0.002) were observed compared to the control. There was no significant difference in the P-selectin level among the groups. Consumption of PPE or Vit E alone significantly reduced the CRP level (mean change for PPE: -3.58 ± 5.41 mg l-1, P < 0.001; mean change for Vit E: -3.25 ± 8.29 mg l-1, P = 0.002) compared to the control. As a result, consumption of PPE in combination with Vit E enhanced the inflammatory status and endothelial function in HD patients.",2020,"Consumption of PPE + Vit E significantly reduced the serum CRP level (mean change: -7.12 ± 4.59 mg l-1, P < 0.001) compared to other groups, while reduced levels of IL-6 (mean change: -2.19 ± 2.33 pg ml-1, P < 0.001), TNF-α (mean change: -2.41 ± 3.21 pg ml-1, P = 0.008), ICAM-1 (mean change: -64.2 ± 111.0 ng ml-1, P = 0.017), and VCAM-1 (mean change: -117.7 ± 177.1 ng ml-1, P = 0.002) were observed compared to the control.","['100 HD patients', 'HD patients', 'hemodialysis patients', 'hemodialysis (HD) patients']","['PPE or Vit E', 'PPE + Vit E, received 2 pomegranate tablets (each tablet contained 225 mg PPE, equal to 90 mg ellagic acid) + 1 Vit E soft gel (400 IU) daily, (b) PPE, received 2 pomegranate tablets + 1 Vit E placebo soft gel daily, (c) Vit E, received 1 Vit E soft gel + 2 pomegranate placebo tablets daily, and (d) placebo, received 2 pomegranate placebo tablets + 1 Vit E placebo soft gel daily', 'pomegranate peel extract (PPE) and vitamin E (Vit E', 'Vit E', 'PPE + Vit E', 'pomegranate peel extract and vitamin E', 'placebo']","['Inflammation and endothelial dysfunction', 'VCAM-1', 'ICAM-1', 'TNF-α', 'CRP level', 'P-selectin level', 'biomarkers of inflammation, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), and the biomarkers of endothelial function, including intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and P-selectin', 'levels of IL-6', 'serum CRP level', 'inflammatory status and endothelial function']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0013900', 'cui_str': 'Ellagic Acid'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",100.0,0.256857,"Consumption of PPE + Vit E significantly reduced the serum CRP level (mean change: -7.12 ± 4.59 mg l-1, P < 0.001) compared to other groups, while reduced levels of IL-6 (mean change: -2.19 ± 2.33 pg ml-1, P < 0.001), TNF-α (mean change: -2.41 ± 3.21 pg ml-1, P = 0.008), ICAM-1 (mean change: -64.2 ± 111.0 ng ml-1, P = 0.017), and VCAM-1 (mean change: -117.7 ± 177.1 ng ml-1, P = 0.002) were observed compared to the control.","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Jafari', 'Affiliation': 'Department of Biochemistry and Nutrition, Faculty of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran. tinajafari15@yahoo.com.'}, {'ForeName': 'Aziz A', 'Initials': 'AA', 'LastName': 'Fallah', 'Affiliation': 'Department of Food Hygiene and Quality Control, Faculty of Veterinary Medicine, Shahrekord University, Shahrekord 34141, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Reyhanian', 'Affiliation': 'Department of Biochemistry and Nutrition, Faculty of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran. tinajafari15@yahoo.com.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sarmast', 'Affiliation': 'Department of Food Hygiene and Quality Control, Faculty of Veterinary Medicine, Shahrekord University, Shahrekord 34141, Iran.'}]",Food & function,['10.1039/d0fo01012j']
2146,32839833,"Clinical outcomes following periodontal surgery and root surface decontamination by erythritol-based air polishing. A randomized, controlled, clinical pilot study.","AIM


To evaluate the outcomes following surgical periodontal treatment and root surface decontamination by means of air polishing using an erythritol powder or conventional mechanical root debridement.
MATERIAL AND METHODS


Thirty systemically healthy patients (44.38 ± 8.2 years old, 11 smokers, 19 women) diagnosed with periodontitis stages III-IV were included. Each patient, with one single-rooted tooth, with one probing pocket depth (PD) ≥ 6 mm associated with horizontal bone loss, was treated by means of simplified papilla preservation flap (SPPF) and randomized to either test treatment (careful removal of the calculus with the tip of a blade, air polishing of the root surfaces with erythritol) or to the control group (scaling and root planing with hand curettes, ultrasonic instruments). PD, clinical attachment (CAL), bone sounding (BS), and radiographic bone level (BL) were evaluated at baseline and 12 months postsurgically.
RESULTS


Twenty-seven patients completed the 12-month follow-up (test: n = 14, control: n = 13). In both groups, statistically significant improvements were obtained (p < 0.05, mean CAL gain/PD reduction: test, 2.50 ± 1.60 mm/3.00 ± 0.96 mm; control, 2.85 ± 1.21 mm/3.38 ± 1.12 mm). No statistically significant differences were observed between the groups for any of the investigated parameters (p < 0.05).
CONCLUSION


Within their limits, the present results indicate that the use of air polishing with an erythritol powder during periodontal surgery may represent a valuable minimally invasive adjunct following calculus removal by means of hand and ultrasonic instruments or a valuable alternative to these, for root surfaces without calculus.
CLINICAL RELEVANCE


The use of air polishing with an erythritol powder during periodontal surgery appears to represent a valuable minimally invasive adjunct following calculus removal by means of hand and ultrasonic instruments or a valuable alternative to these, for root surfaces without calculus.",2020,"In both groups, statistically significant improvements were obtained (p < 0.05, mean ","['Twenty-seven patients completed the 12-month follow-up (test: n = 14, control: n = 13', 'Thirty systemically healthy patients (44.38 ± 8.2 years old, 11 smokers, 19 women) diagnosed with periodontitis stages III-IV were included']","['periodontal surgery and root surface decontamination by erythritol-based air polishing', 'simplified papilla preservation flap (SPPF) and randomized to either test treatment (careful removal of the calculus with the tip of a blade, air polishing of the root surfaces with erythritol) or to the control group (scaling and root planing with hand curettes, ultrasonic instruments']","['PD, clinical attachment (CAL), bone sounding (BS), and radiographic bone level (BL']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0398950', 'cui_str': 'Periodontal operation'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0014757', 'cui_str': 'Erythritol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180236', 'cui_str': 'Curette'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0427006,"In both groups, statistically significant improvements were obtained (p < 0.05, mean ","[{'ForeName': 'Raluca', 'Initials': 'R', 'LastName': 'Cosgarea', 'Affiliation': 'Department of Periodontology, Operative and Preventive Dentistry, University of Bonn, Welschnonnenstr. 17, 53111, Bonn, Germany. ralucacosgarea@gmail.com.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Jepsen', 'Affiliation': 'Department of Periodontology, Operative and Preventive Dentistry, University of Bonn, Welschnonnenstr. 17, 53111, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Aura', 'Initials': 'A', 'LastName': 'Bodea', 'Affiliation': 'Periodontal Private Practice for Periodontology, Gheorghe Doja Str. 9, 400068, Cluj-Napoca, Romania.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, University Bern, Bern, Switzerland, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, University Bern, Bern, Switzerland, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}]",Clinical oral investigations,['10.1007/s00784-020-03533-9']
2147,32839843,Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis.,"In this post hoc analysis of the Denosumab Fracture Intervention Randomized Placebo-Controlled Trial (DIRECT) in Japanese postmenopausal women and men with osteoporosis, we evaluated the relationship between vertebral fracture risk and both bone mineral density (BMD) T-score and percent change after 24 months of denosumab treatment at total hip, femoral neck, and lumbar spine. Logistic regression analysis was performed and the proportion of treatment effect explained by BMD in vertebral fracture risk was estimated. The results demonstrate that both total hip BMD T-score and change can be strong predictors of subsequent fracture risk, and that total hip BMD change explained 73%, while T-score explained 23%, of the treatment effect. In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk. Furthermore, although lumbar spine BMD T-score was associated with vertebral fracture incidence, lumbar spine BMD change was inversely related to vertebral fracture risk. Because there was no relationship between lumbar spine BMD change and T-score at 24 months of denosumab treatment, and because there can be small undetectable vertebral deformities that may increase BMD values, these results suggest that lumbar spine BMD change is not a good surrogate for vertebral fracture risk assessment. It is suggested that both total hip BMD change and T-score can be good surrogates for predicting vertebral fracture risk in Japanese patients with osteoporosis under denosumab treatment.ClinicalTrials.gov identifier: NCT00680953.",2020,"In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk.","['Japanese postmenopausal women and men with osteoporosis', 'Japanese patients with osteoporosis under denosumab treatment', 'Japanese Postmenopausal Women and Men with Osteoporosis']","['Placebo', 'denosumab', 'Denosumab Treatment']","['vertebral fracture risk', 'femoral neck BMD change nor T-score', 'total hip BMD change', 'lumbar spine BMD change and T-score', 'BMD values', 'vertebral fracture incidence, lumbar spine BMD change', 'total hip BMD T-score', 'vertebral fracture risk and both bone mineral density (BMD) T-score', 'lumbar spine BMD T-score', 'total hip BMD change and T-score']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0191312,"In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Okubo', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan. okubo.naoki.d8@daiichisankyo.co.jp.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Eikokai Ono Hospital, Hyogo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Kenkoin Clinic, Tokyo, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Osakabe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Takami', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.'}]",Calcified tissue international,['10.1007/s00223-020-00750-y']
2148,32839849,No difference in union and recurrence rate between iliac crest autograft versus allograft following medial opening wedge high tibial osteotomy: a randomized controlled trial.,"PURPOSE


Using iliac crest autograft has been considered as gold standard for gap filling in medial opening wedge high tibial osteotomy (MOW-HTO) but is associated with donor site morbidity and pain. The purpose of this study was to compare the results of the use of iliac crest autograft versus allograft from the same anatomic site in terms of union and recurrence.
METHODS


Forty-six patients with genovarum with or without medial compartment osteoarthritis were enrolled based on specific inclusion and exclusion criteria and were randomly assigned into two groups. MOW-HTO was done using iliac crest allograft (23 patients) or autograft (23 patients) as void filler. Follow-up visits were done monthly for the first 3 months and then every 3 months until 1 year and then at 5th and 8th postoperative year. The clinical assessment of union, anatomical indices of proximal tibia, complications and WOMAC score were assessed for both groups.
RESULTS


The amount of correction (degrees), recurrence, complication rates, time to get symptom-free, radiologic union and knee scores was similar in both groups. The symptom-free time was 6.1 (SD = 0.9) weeks in autograft group versus 6.2 (SD = 0.8) weeks in allograft group (p = 0.73, 95% CI  - 0.4 to 0.6). The time to radiologic union had a between-group difference of 0.3 weeks (p = 0.58, 95% CI  - 1.6 to 0.9). There was one case of surgical site infection in graft harvest site. No nonunion or delayed union was encountered in either group. Fifty-two percent of the autograft patients reported more intense postoperative pain in iliac graft harvest site than tibial osteotomy site.
CONCLUSIONS


According to our results, iliac crest allograft can be safely used in MOW-HTO with comparable efficacy and safety to iliac crest autograft.
CLINICAL TRIAL REGISTRY


The clinical trial was approved by clinicaltrial.gov with identifier NCT00595712.",2020,No nonunion or delayed union was encountered in either group.,['Forty-six patients with genovarum with or without medial compartment osteoarthritis were enrolled based on specific inclusion and exclusion criteria'],"['medial opening wedge high tibial osteotomy', 'iliac crest autograft versus allograft', 'iliac crest autograft']","['intense postoperative pain', 'union and recurrence rate', 'time to radiologic union', 'surgical site infection', 'amount of correction (degrees), recurrence, complication rates, time to get symptom-free, radiologic union and knee scores', 'symptom-free time', 'clinical assessment of union, anatomical indices of proximal tibia, complications and WOMAC score', 'nonunion or delayed union']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0588198', 'cui_str': 'Bone structure of proximal tibia'}]",46.0,0.170519,No nonunion or delayed union was encountered in either group.,"[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Haghpanah', 'Affiliation': 'Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Kaseb', 'Affiliation': 'Joint Reconstruction Research Center, Tehran University of Medical Science, End of Keshavarz Blvd, 1419733141, Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Espandar', 'Affiliation': 'Joint Reconstruction Research Center, Tehran University of Medical Science, End of Keshavarz Blvd, 1419733141, Tehran, Iran.'}, {'ForeName': 'S M Javad', 'Initials': 'SMJ', 'LastName': 'Mortazavi', 'Affiliation': 'Joint Reconstruction Research Center, Tehran University of Medical Science, End of Keshavarz Blvd, 1419733141, Tehran, Iran. smjmort@yahoo.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06240-w']
2149,32839856,A new universal 3D-printable device to prevent excessive drilling in orthopedic surgery.,"INTRODUCTION


The occurrence of vascular injury during drilling is a rare but severe complication. Unfortunately, drilling protection systems are not available in all hospitals. Thanks to the development of 3D printing in recent years, sharing devices and materials to solve surgical problems has become easy and inexpensive. The objective of our work is to evaluate a universal, freely accessible, 3D-printable drilling protection device.
MATERIALS AND METHODS


A prospective, randomized, and triple-blind evaluation of excess drilling was evaluated in expert surgeons and resident surgeons without the use of the protection device. Subsequently, excess drilling was assessed using the device in both groups. The differences in drilling lengths between both groups with and without the device were analyzed to establish the reduction of excess drilling in both groups.
RESULTS


The drilling in the expert surgeon without device group was 3.03 mm (SD 1.69 95% CI 2.40-3.66 p value = 9.89e-11), while the resident surgeon with device group performed excess drilling of 1.76 mm (SD 0.89 CI 95% 1.43-2.10). Results showed better results in the resident surgeon with device group than in the expert surgeons with device group (p value ˂ 0.01). The device improved drilling in both resident surgeons (5.77 mm) and expert surgeons (1.17 mm).
CONCLUSIONS


The device improves drilling in both expert surgeons and resident surgeons, showing greater benefits in the latter. The device is printable with any 3D printer, making it universally accessible, inexpensive, and effective, allowing expert surgeons to improve precision in high-risk situations and resident surgeons to improve their technique without increasing risk to the patient.",2020,"The device improved drilling in both resident surgeons (5.77 mm) and expert surgeons (1.17 mm).
",[],[],['drilling lengths'],[],[],"[{'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.0676048,"The device improved drilling in both resident surgeons (5.77 mm) and expert surgeons (1.17 mm).
","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Ferràs-Tarragó', 'Affiliation': 'La Fe Hospital, Av Fernando Abril Martorell 106, 46026, Valencia, Spain. cotferras@gmail.com.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Jordà-Gómez', 'Affiliation': 'La Fe Hospital, Av Fernando Abril Martorell 106, 46026, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Català-de-Las-Marinas', 'Affiliation': 'La Fe Hospital, Av Fernando Abril Martorell 106, 46026, Valencia, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Antequera-Cano', 'Affiliation': 'La Fe Hospital, Av Fernando Abril Martorell 106, 46026, Valencia, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Barrés-Carsí', 'Affiliation': 'La Fe Hospital, Av Fernando Abril Martorell 106, 46026, Valencia, Spain.'}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-020-01465-3']
2150,32839957,Examining the Role of Lateral Parietal Cortex in Emotional Distancing Using TMS.,"We recently proposed a neurocognitive model of distancing-an emotion regulation tactic-with a focus on the lateral parietal cortex. Although this brain area has been implicated in both cognitive control and self-projection processes during distancing, fMRI work suggests that these processes may be dissociable here. This preregistered (NCT03698591) study tested the contribution of left temporoparietal junction (TPJ) to distancing using repetitive transcranial magnetic stimulation. We hypothesized that inhibiting left TPJ would decrease the efficiency of distancing but not distraction, another regulation tactic with similar cognitive control requirements, thus implicating this region in the self-projection processes unique to distancing. Active and sham continuous theta burst stimulation (cTBS) were applied to 30 healthy adults in a single-session crossover design. Tactic efficiency was measured using online reports of valence and effort. The stimulation target was established from the group TPJ fMRI activation peak in an independent sample using the same distancing task, and anatomical MRI scans were used for individual targeting. Analyses employed both repeated-measures ANOVA and analytic procedures tailored to crossover designs. Irrespective of cTBS, distancing led to greater decreases in negative valence over time relative to distraction, and distancing effort decreased over time while distraction effort remained stable. Exploratory analyses also revealed that active cTBS made distancing more effortful, but not distraction. Thus, left TPJ seems to support self-projection processes in distancing, and these processes may be facilitated by repeated use. These findings help to clarify the role of lateral parietal cortex in distancing and inform applications of distancing and distraction.",2020,"Irrespective of cTBS, distancing led to greater decreases in negative valence over time relative to distraction, and distancing effort decreased over time while distraction effort remained stable.",['30 healthy adults'],"['left temporoparietal junction (TPJ) to distancing using repetitive transcranial magnetic stimulation', 'Active and sham continuous theta burst stimulation (cTBS']","['Tactic efficiency', 'negative valence']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",30.0,0.0111624,"Irrespective of cTBS, distancing led to greater decreases in negative valence over time relative to distraction, and distancing effort decreased over time while distraction effort remained stable.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Powers', 'Affiliation': 'Department of Psychology & Neuroscience, Duke University, Center for Cognitive Neuroscience, Box 90999, Durham, NC, 27708-0999, USA.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrada D', 'Initials': 'AD', 'LastName': 'Neacsiu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'LaBar', 'Affiliation': 'Department of Psychology & Neuroscience, Duke University, Center for Cognitive Neuroscience, Box 90999, Durham, NC, 27708-0999, USA. klabar@duke.edu.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00821-5']
2151,32839976,Matrix stimulation in chronic pruritus: A randomized controlled study.,"Chronic pruritus is one of the main symptoms in dermatology. We investigated a new intervention for chronic pruritus by neurostimulation through matrix electrodes. In this randomized controlled trial, 29 patients with chronic pruritus caused by a variety of dermatological diseases were allocated to an experimental group (EG; n = 14, 4-Hz neurostimulation of the itching area through matrix electrodes) or the control group (CG; n = 15, placement of matrix electrodes without neurostimulation). Outcome measures were the itching sensation as measured by a Numerical Rating Scale immediately after the intervention and the intermediate effect measured by the average itching sensation on the day before the intervention compared with the average itching sensation on day 1, 2 and 3 after the intervention. Regarding the short-term effect on itching, the anova showed a significant interaction effect for the 5-min stimulation with a larger reduction in the EG with a large effect size of d = 1.10. The average reduction in itching intensity was 78.2% for the EG compared with 34.3% for the CG. For the intermediate effect, no significant interaction was found (F = 1.721, P = 0.199). Comparing the itching sensation at day 0 with day 3, the interaction effect showed a statistical trend toward a greater reduction in the EG (F = 3.178, P = 0.086; statistical trend, d = 0.69). This study proved that neurostimulation through matrix electrodes is effective in the short-term reduction of itching in patients with chronic pruritus caused by dermatological diseases. Additional studies are needed with larger patient pools and covering longer study periods.",2020,"For the intermediate effect, no significant interaction was found (F = 1.721, P = 0.199).","['patients with chronic pruritus caused by dermatological diseases', 'chronic pruritus', '29 patients with chronic pruritus caused by a variety of dermatological diseases']","['Matrix stimulation', 'experimental group (EG; n\xa0=\xa014, 4-Hz neurostimulation of the itching area through matrix electrodes) or the control group (CG; n\xa0=\xa015, placement of matrix electrodes without neurostimulation']","['average itching sensation', 'itching sensation', 'itching intensity', 'itching sensation as measured by a Numerical Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]","[{'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",29.0,0.0175214,"For the intermediate effect, no significant interaction was found (F = 1.721, P = 0.199).","[{'ForeName': 'Jan-Philipp', 'Initials': 'JP', 'LastName': 'Witte', 'Affiliation': 'Department of Palliative Medicine, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Dimitrij', 'Initials': 'D', 'LastName': 'Kravchenko', 'Affiliation': 'Department of Radiology, Medical School and Hospital, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Milka', 'Initials': 'M', 'LastName': 'Marinova', 'Affiliation': 'Department of Radiology, Medical School and Hospital, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Küborth', 'Affiliation': 'Departments of, Dermatology and Allergology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Radbruch', 'Affiliation': 'Department of Palliative Medicine, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mücke', 'Affiliation': 'Center for Rare Diseases Bonn (ZSEB), University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Conrad', 'Affiliation': 'Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}]",The Journal of dermatology,['10.1111/1346-8138.15492']
2152,32839990,Randomized controlled trial of oral bicarbonate treatment for labor stagnation.,"AIM


The aim of this study was to determine the effect of oral sodium bicarbonate solution on delivery outcome of primiparous women with labor stagnation.
METHODS


This randomized controlled trial study was performed on 142 primiparous pregnant women referred to Jiroft University hospitals who had stagnation during labor. In the intervention group, in addition to oxytocin, 4.26 g of sodium bicarbonate dissolved in 200 mL of water were given orally. The control group received only oxytocin. Data were analyzed by t-test and chi-square test.
RESULTS


The mean interval of dilatation stopping to delivery in the intervention group was significantly lower than the control group (202.34 vs 304.08 min, P = 0.001). The mean duration of the first and second stages of labor in the intervention group was lower than the control group (280.44 vs 397.16 and 35.00 vs 51.72 min respectively, P = 0.001). There was no statistically significant difference between the intervention and control groups in the rate of cesarean section and Apgar score. In the intervention group, the rate of spontaneous delivery was significantly higher (65 vs 56 cases, P = 0.03) than the control group.
CONCLUSION


The results of the present study could suggest the use of oral bicarbonate in stagnation as a cheap and no-cost method to facilitate normal vaginal delivery.",2020,"In the intervention group, the rate of spontaneous delivery was significantly higher (65 vs 56 cases, P = 0.03) than the control group.
","['labor stagnation', '142 primiparous pregnant women referred to Jiroft University hospitals who had stagnation during labor', 'primiparous women with labor stagnation']","['oral bicarbonate', 'oral sodium bicarbonate solution', 'oxytocin', 'sodium bicarbonate']","['mean duration of the first and second stages of labor', 'rate of spontaneous delivery', 'rate of cesarean section and Apgar score', 'mean interval of dilatation stopping to delivery']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]",142.0,0.0760926,"In the intervention group, the rate of spontaneous delivery was significantly higher (65 vs 56 cases, P = 0.03) than the control group.
","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Seyedi', 'Affiliation': 'School of Nursing and Midwifery, Geriatric Care Research Centre, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Ghorashi', 'Affiliation': 'School of Nursing and Midwifery, Geriatric Care Research Centre, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Sedighi Darijani', 'Affiliation': 'School of Medicine, Jiroft University of Medical Sciences, Jiroft, Iran.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14438']
2153,32840012,Effect of epigallocatechin-3-gallate on the status of DNA methylation of E-cadherin promoter region on endometriosis mouse.,"AIM


To evaluate whether epigallocatechin-3-gallate acts on endometriosis mouse, and changes the status of DNA methylation of E-cadherin promoter region.
METHODS


According to our previous research, the tracing nude mouse model of endometriosis was built up and randomly divided into three groups: control group (group A), epigallocatechin-3-gallate group (group B) and decitabine group (group C). Normal saline, epigallocatechin-3-gallate and decitabine were isometrically intraperitoneally injected into each group once in 2 days. In this period, the growth situations of lesions were monitored by living image system. After 16 days, the lesions were taken out and the distribution of E-cadherin and its methylated situation of promoter region were analyzed.
RESULTS


The region of interest of ectopic lesion increased from 4th to 16th day in group A (P < 0.01); in group B and C, the region of interest of ectopic lesion increased in the 0-8th day (P < 0.01), and decreased in the 8-16th day (P < 0.01). The positive expression rate of E-cadherin in group C was higher than group B, and group B was higher than group A (P < 0.01). The DNA methylation status of E-cadherin promoter region in group A was higher than group B, and group B was higher than group C (P < 0.01).
CONCLUSION


Epigallocatechin-3-gallate may inhibit the growth of endometrial lesion, affect the expression of E-cadherin on the cell membrane and reduce the status of DNA methylation of E-cadherin promoter region.",2020,"The DNA methylation status of E-cadherin promoter region in group A was higher than group B, and group B was higher than group C (P < 0.01).
",[],"['Normal saline, epigallocatechin-3-gallate and decitabine', 'decitabine', 'epigallocatechin-3-gallate', 'Epigallocatechin-3-gallate']","['region of interest of ectopic lesion', 'positive expression rate of E-cadherin']",[],"[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0042172', 'cui_str': 'E-Cadherin'}]",,0.0206581,"The DNA methylation status of E-cadherin promoter region in group A was higher than group B, and group B was higher than group C (P < 0.01).
","[{'ForeName': 'Qi-Hui', 'Initials': 'QH', 'LastName': 'Guan', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wen-Jing', 'Initials': 'WJ', 'LastName': 'Shi', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Long-Shu', 'Initials': 'LS', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tao', 'Affiliation': 'Guangdong Provincial Key Laboratory of Allergy and Clinical Immunology, The State Key Laboratory of Respiratory Disease, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14358']
2154,32840121,The Role of Natriuretic Peptides in the Regulation of Cardiac Tolerance to Ischemia/Reperfusion and Postinfarction Heart Remodeling.,"In the past 10 years, mortality from acute myocardial infarction has not decreased despite the widespread introduction of percutaneous coronary intervention. The reason for this situation is the absence in clinical practice of drugs capable of preventing reperfusion injury of the heart with high efficiency. In this regard, noteworthy natriuretic peptides (NPs) which have the infarct-limiting effect, prevent reperfusion cardiac injury, prevent adverse post-infarction remodeling of the heart. Atrial natriuretic peptide does not have the infarct-reducing effect in rats with alloxan-induced diabetes mellitus. NPs have the anti-apoptotic and anti-inflammatory effects. There is indirect evidence that NPs inhibit pyroptosis and autophagy. Published data indicate that NPs inhibit reactive oxygen species production in cardiomyocytes, aorta, heart, kidney and the endothelial cells. NPs can suppress aldosterone, angiotensin II, endothelin-1 synthesize and secretion. NPs inhibit the effects aldosterone, angiotensin II on the post-receptor level through intracellular signaling events. NPs activate guanylyl cyclase, protein kinase G and protein kinase A, and reduce phosphodiesterase 3 activity. NO-synthase and soluble guanylyl cyclase are involved in the cardioprotective effect of NPs. The cardioprotective effect of natriuretic peptides is mediated via activation of kinases (AMPK, PKC, PI3 K, ERK1/2, p70s6 k, Akt) and inhibition of glycogen synthase kinase 3β. The cardioprotective effect of NPs is mediated via sarcolemmal K ATP  channel and mitochondrial K ATP  channel opening. The cardioprotective effect of brain natriuretic peptide is mediated via MPT pore closing. The anti-fibrotic effect of NPs may be mediated through inhibition TGF-β1 expression. Natriuretic peptides can inhibit NF-κB activity and activate GATA. Hemeoxygenase-1 and peroxisome proliferator-activated receptor γ may be involved in the infarct-reducing effect of NPs. NPs exhibit the infarct-limiting effect in patients with acute myocardial infarction. NPs prevent post-infarction remodeling of the heart. To finally resolve the question of the feasibility of using NPs in AMI, a multicenter, randomized, blind, placebo-controlled study is needed to assess the effect of NPs on the mortality of patients after AMI.",2020,The cardioprotective effect of NPs is mediated via sarcolemmal K ATP  channel and mitochondrial K ATP  channel opening.,"['rats with alloxan-induced diabetes mellitus', 'patients with acute myocardial infarction', 'patients after AMI']",['placebo'],"['aldosterone, angiotensin II, endothelin-1 synthesize and secretion', 'NPs activate guanylyl cyclase, protein kinase', 'k, Akt) and inhibition of glycogen synthase kinase']","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0002151', 'cui_str': 'Alloxan'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0018358', 'cui_str': 'Guanylate cyclase'}, {'cui': 'C0033640', 'cui_str': 'Protein kinase'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0206354', 'cui_str': 'Glycogen Synthase Kinase'}]",,0.0299786,The cardioprotective effect of NPs is mediated via sarcolemmal K ATP  channel and mitochondrial K ATP  channel opening.,"[{'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Krylatov', 'Affiliation': 'Cardiology Research Institute, Tomsk National Research Medical Center of the RAS, Tomsk, Russia.'}, {'ForeName': 'Sergey Y', 'Initials': 'SY', 'LastName': 'Tsibulnikov', 'Affiliation': 'Cardiology Research Institute, Tomsk National Research Medical Center of the RAS, Tomsk, Russia.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Mukhomedzyanov', 'Affiliation': 'Cardiology Research Institute, Tomsk National Research Medical Center of the RAS, Tomsk, Russia.'}, {'ForeName': 'Alla A', 'Initials': 'AA', 'LastName': 'Boshchenko', 'Affiliation': 'Cardiology Research Institute, Tomsk National Research Medical Center of the RAS, Tomsk, Russia.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Goldberg', 'Affiliation': 'Cancer Research Institute, Tomsk National Research Medical Center of the RAS, Tomsk, Russia.'}, {'ForeName': 'Amteshwar S', 'Initials': 'AS', 'LastName': 'Jaggi', 'Affiliation': 'Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, India.'}, {'ForeName': 'Reinhold G', 'Initials': 'RG', 'LastName': 'Erben', 'Affiliation': 'Department of Biomedical Research, Institute of Physiology, Pathophysiology and Biophysics, University of Veterinary Medicine, Vienna, Austria.'}, {'ForeName': 'Leonid N', 'Initials': 'LN', 'LastName': 'Maslov', 'Affiliation': 'Cardiology Research Institute, Tomsk National Research Medical Center of the RAS, Tomsk, Russia.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420952243']
2155,32840126,Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.,"BACKGROUND


Cancer patients often experience decreased quality of life during chemotherapy. This study aimed to determine the preliminary efficacy and safety of Reishi & Privet Formula (RPF) for maintaining quality of life among patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy.
METHODS


We conducted a phase II randomized, double-blind, placebo-controlled clinical trial in China. Adults with NSCLC scheduled to receive chemotherapy were randomly assigned (3:1 ratio) to receive oral RPF (3.36 g/day) or placebo daily for 6 weeks. The main outcome was the Functional Assessment of Cancer Therapy-Lung (FACT-L). We evaluated RPF's safety profile using the Common Terminology Criteria for Adverse Events and assessed changes in outcome measures from baseline to weeks 3 and 6 using a linear mixed effects model.
RESULTS


We enrolled 82 participants across 8 cancer centers in China. The median age was 59 years, 56 (68%) had advanced cancer. Compared with the placebo group, the RPF group had nonstatistically significant higher quality of life as measured by the FACT-L total score ( P  = .086) over 2 cycles of chemotherapy. The RPF group was associated with a nonsignificant better general health ( P  = .050) and emotional well-being ( P  = .090) than the placebo group. Adverse events rates did not differ between groups.
CONCLUSIONS


This study demonstrated preliminary safety and suggests a promising trend in RPF's effect on maintaining quality of life and emotional well-being among NSCLC patients undergoing chemotherapy. Future adequately powered randomized-controlled trials are needed to verify the efficacy and safety of RPF in cancer patients undergoing chemotherapy.",2020,The RPF group was associated with a nonsignificant better general health ( P  = .050) and emotional well-being ( P  = .090) than the placebo group.,"['NSCLC patients undergoing chemotherapy', 'cancer patients undergoing chemotherapy', '82 participants across 8 cancer centers in China', 'Adults with NSCLC scheduled to receive', 'Cancer patients', 'The median age was 59 years, 56 (68%) had advanced cancer', 'patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy', 'China', 'Non-Small Cell Lung Cancer Patients']","['Undergoing Chemotherapy', 'Reishi & Privet Formula', 'Reishi & Privet Formula (RPF', 'oral RPF', 'placebo', 'Placebo', 'RPF', 'chemotherapy']","['Quality of Life', 'general health', 'FACT-L total score', 'Adverse events rates', 'quality of life', 'Functional Assessment of Cancer Therapy-Lung']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0752326', 'cui_str': 'Lingzhi'}, {'cui': 'C0995160', 'cui_str': 'Genus Ligustrum'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",82.0,0.770987,The RPF group was associated with a nonsignificant better general health ( P  = .050) and emotional well-being ( P  = .090) than the placebo group.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Susan Qing', 'Initials': 'SQ', 'LastName': 'Li', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Guang An Men Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420944491']
2156,32840155,Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study).,"BACKGROUND


With limited real-world insulin glargine 300 U/mL (Gla-300) data among Japanese patients with type 1 diabetes mellitus (T1DM) available, the authors describe its effectiveness and safety in Japanese T1DM patients switching to Gla-300.
RESEARCH DESIGN AND METHODS


X-STAR was a 12-month prospective, observational, post-marketing study in Japanese patients with diabetes mellitus from 2015 to 2018: insulin-experienced T1DM patients initiating Gla-300 were analyzed.
RESULTS


Of 774 patients, mean (±standard deviation) HbA1c (%) and fasting plasma glucose (mg/dL) decreased from 8.27 ± 1.55 to 8.15 ± 1.35 (by -0.12 ± 1.30 [p = 0.013]) and 167.9 ± 92.6 to 153.9 ± 70.9 (by -13.9 ± 103.8 [p = 0.067]) from baseline to month 12, respectively. A total of 16.3% achieved HbA1c <7.0% at month 12. Gla-300 dose increased by 1.13 ± 3.18 U/day (0.02 ± 0.05 U/kg/day) (p < 0.001), with a + 0.22 ± 2.70 (p = 0.037) body-weight change (kg) from baseline 60.83 ± 12.81 to 12-month 61.06 ± 12.89. Adverse drug reactions (ADRs) and serious ADRs occurred in 9.82% and 0.78% of the patients, respectively. Hypoglycemia was the most common ADR (9.30%). In total, 88.9% adhered to Gla-300 administration schedules, whereas <40% adhered to exercise and dietary instructions, respectively.
CONCLUSIONS


Gla-300 showed no unprecedented safety concerns for insulin-experienced T1DM patients in Japanese clinical settings. Our results provide insights into strategies for blunted Gla-300 up-titration dose, despite insufficient HbA1c control and lifestyle modification.",2020,"Gla-300 dose increased by 1.13 ± 3.18 U/day (0.02 ± 0.05 U/kg/day) (p < 0.001), with a + 0.22 ± 2.70 (p = 0.037) body-weight change (kg) from baseline 60.83 ± 12.81 to 12-month 61.06 ± 12.89.","['Japanese patients with type 1 diabetes mellitus (T1DM', 'Japanese patients with diabetes mellitus from 2015 to 2018: insulin-experienced T1DM patients initiating Gla-300 were analyzed', 'Japanese patients with type 1 diabetes']","['insulin glargine 300 U/mL', 'U/mL']","['Adverse drug reactions (ADRs) and serious ADRs', 'Hypoglycemia', 'fasting plasma glucose']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",,0.0227963,"Gla-300 dose increased by 1.13 ± 3.18 U/day (0.02 ± 0.05 U/kg/day) (p < 0.001), with a + 0.22 ± 2.70 (p = 0.037) body-weight change (kg) from baseline 60.83 ± 12.81 to 12-month 61.06 ± 12.89.","[{'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University , Tokushima, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Odawara', 'Affiliation': 'Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University , Tokyo, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Graduate School of Medicine , Tokyo, Japan.'}, {'ForeName': 'Ryusuke', 'Initials': 'R', 'LastName': 'Koshida', 'Affiliation': 'Medical Affairs, Sanofi K.K ., Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Senda', 'Affiliation': 'Medical Affairs, Sanofi K.K ., Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, Division of Metabolism and Endocrinology, St. Marianna University School of Medicine , Kawasaki, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Yokohama City, University Graduate School of Medicine , Yokohama, Japan.'}]",Expert opinion on pharmacotherapy,['10.1080/14656566.2020.1810665']
2157,32840169,Priming Self-Affirmation Reduces the Negative Impact of High Rape Myth Acceptance: Assessing Women's Perceptions and Judgments of Sexual Assault.,"Researchers have theorized and empirically shown that compared with low rape myth acceptance (RMA) individuals, those high in RMA are more likely to discount rape prevention messages. These researchers have urged the development of approaches to counteract the defensiveness and related processes that are presumed to cause such discounting. In the present research we empirically tested the effectiveness of a self-affirmation approach designed to reduce defensiveness to and increase engagement with important but potentially self-threatening information about sexual assault. Female participants classified as low or high in RMA were randomly assigned to either a self-affirmation or no-affirmation control condition and then read about a controversial case of campus sexual assault. We found support for the effectiveness of such a self-affirmation intervention for high-RMA women. Specifically, on a questionnaire administered after the exposure, affirmed high-RMA women relative to the control group reported greater endorsement of the realistic use of the ""yes means yes"" standard of consent, higher self-standards in defining consensual sexual behavior, increases in perceived knowledge of available resources for sexual assault victims, lower support of rape myths, and greater support for punishing someone convicted of sexual assault. As expected, for women low in RMA there were no significant differences in reporting on these measures between the affirmation condition and the no-affirmation condition. From an agentic perspective these results are encouraging. This approach may merit further development as part of an intervention for reducing biased processing and increasing the effectiveness of consent campaigns and other sexual violence prevention programs.",2020,"As expected, for women low in RMA there were no significant differences in reporting on these measures between the affirmation condition and the no-affirmation condition.","['Female participants classified as low or high in RMA', 'high-RMA women']",['self-affirmation or no-affirmation control condition and then read about a controversial case of campus sexual assault'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034668', 'cui_str': 'Forcible intercourse'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}]",[],,0.0179758,"As expected, for women low in RMA there were no significant differences in reporting on these measures between the affirmation condition and the no-affirmation condition.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Huppin', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Malamuth', 'Affiliation': 'University of California, Los Angeles, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520951312']
2158,32840201,"Impact of Low-Cost Point-of-Use Water Treatment Technologies on Enteric Infections and Growth among Children in Limpopo, South Africa.","Enteric infections early in life have been associated with poor linear growth among children in low-resource settings. Point-of-use water treatment technologies provide effective and low-cost solutions to reduce exposure to enteropathogens from drinking water, but it is unknown whether the use of these technologies translates to improvements in child growth. We conducted a community-based randomized controlled trial of two water treatment technologies to estimate their effects on child growth in Limpopo, South Africa. We randomized 404 households with a child younger than 3 years to receive a silver-impregnated ceramic water filter, a silver-impregnated ceramic tablet, a safe-storage water container alone, or no intervention, and these households were followed up quarterly for 2 years. We estimated the effects of the interventions on linear and ponderal growth, enteric infections assessed by quantitative molecular diagnostics, and diarrhea prevalence. The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples. However, the filters and tablets were not associated with differences in height (height-for-age  z -score differences compared with no intervention: 0.06, 95% CI: -0.29, 0.40, and 0.00, 95% CI: -0.35, 0.35, respectively). There were also no effects of the interventions on weight, diarrhea prevalence, or enteric infections. Despite their effectiveness in treating drinking water, the use of the silver-impregnated ceramic water filters and tablets did not reduce enteric infections or improve child growth. More transformative water, sanitation, and hygiene interventions that better prevent enteric infections are likely needed to improve long-term child growth outcomes.",2020,"The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples.","['Children in Limpopo, South Africa', '404 households with a child younger than 3 years to receive a', 'child growth in Limpopo, South Africa']","['silver-impregnated ceramic water filter, a silver-impregnated ceramic tablet, a safe-storage water container alone, or no intervention', 'Low-Cost Point-of-Use Water Treatment Technologies']","['enteric infections', 'weight, diarrhea prevalence, or enteric infections', 'linear and ponderal growth, enteric infections assessed by quantitative molecular diagnostics, and diarrhea prevalence', 'total coliform bacteria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0180098', 'cui_str': 'Container'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C2121080', 'cui_str': 'Molecular Diagnostics'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0314760', 'cui_str': 'Coliform bacteria'}]",404.0,0.0517983,"The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples.","[{'ForeName': 'Courtney L', 'Initials': 'CL', 'LastName': 'Hill', 'Affiliation': 'Department of Engineering Systems and Environment, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McCain', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mzwakhe E', 'Initials': 'ME', 'LastName': 'Nyathi', 'Affiliation': 'Department of Animal Science, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Edokpayi', 'Affiliation': 'Department of Hydrology and Water Resources Mining and Environmental Geology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kahler', 'Affiliation': 'Center for Environmental Research and Education, Duquesne University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Darwin J', 'Initials': 'DJ', 'LastName': 'Operario', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'David D J', 'Initials': 'DDJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Civil and Mineral Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Wright', 'Affiliation': 'Department of Mechanical Engineering, University of Minnesota Twin Cities, Minneapolis, Minnesota.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Engineering Systems and Environment, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Amidou', 'Initials': 'A', 'LastName': 'Samie', 'Affiliation': 'Department of Microbiology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Dillingham', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Pascal O', 'Initials': 'PO', 'LastName': 'Bessong', 'Affiliation': 'Department of Microbiology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0228']
2159,32840230,"Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial (HUC-HEART Trial).","Background and Objectives


The HUC-HEART Trial (ClinicalTrials.gov Identifier: NCT02323477) was a controlled, prospective, phase I/II, multicenter, single-blind, three-arm randomized study of intramyocardial delivery of human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG) in patients with chronic ischemic cardiomyopathy (CIC). The trial aimed to assess (i) the safety and the efficacy of cell transplantation during one-year follow-up, (ii) to compare the efficacy of HUC-MSCs with autologous bone-marrow- derived mononuclear cells (BM-MNCs) in the same clinical settings.
Methods and Results


Fifty-four patients who were randomized to receive HUC-MSCs (23×10 6 ) (n=26) or BM-MNCs (70×10 7 ) (n=12) in combination with CABG surgery. The control patients (n=16) received no cells/vehicles but CABG intervention. All patients were screened at baseline and 1, 3, 6, 12 months after transplantation. Forty-six (85%) patients completed 12 months follow-up. No short/mid-term adverse events were encountered. Decline in NT-proBNP (baseline∼ 6 months) in both cell-treated groups; an increase in left ventricular ejection fraction (LVEF) (5.4%) and stroke volume (19.7%) were noted (baseline∼6 or 12 months) only in the HUC-MSC group. Decreases were also detected in necrotic myocardium as 2.3% in the control, 4.5% in BM-MNC, and 7.7% in the HUC-MSC groups. The 6-min walking test revealed an increase in the control (14.4%) and HUC-MSC (23.1%) groups.
Conclusions


Significant findings directly related to the intramyocardial delivery of HUC-MSCs justified their efficacy in CIC. Stricter patient selection criteria with precisely aligned cell dose and delivery intervals, rigorous follow-up by detailed diagnostic approaches would further help to clarify the responsiveness to the therapy.",2020,"The 6-min walking test revealed an increase in the control (14.4%) and HUC-MSC (23.1%) groups.
","['23×10 6 ) (n=26) or BM-MNCs (70×10 7 ', 'Chronic Ischemic Cardiomyopathy', 'patients with chronic ischemic cardiomyopathy (CIC']","['HUC-MSCs with autologous bone-marrow- derived mononuclear cells (BM-MNCs', 'no cells/vehicles but CABG intervention', 'Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells', 'intramyocardial delivery of human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG', 'CABG surgery', 'HUC-MSCs']","['left ventricular ejection fraction (LVEF', 'HUC-MSC', 'Decline in NT-proBNP', 'necrotic myocardium', '6-min walking test', 'stroke volume']","[{'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",54.0,0.0887874,"The 6-min walking test revealed an increase in the control (14.4%) and HUC-MSC (23.1%) groups.
","[{'ForeName': 'A Tulga', 'Initials': 'AT', 'LastName': 'Ulus', 'Affiliation': 'Department of Cardiovascular Surgery, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Mungan', 'Affiliation': 'Ankara University Biotechnology Institute and Sisbiyotek, Ankara, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kurtoglu', 'Affiliation': 'Cardiovascular Surgery Division, Ankara Guven Hospital, Ankara, Turkey.'}, {'ForeName': 'Ferda Topal', 'Initials': 'FT', 'LastName': 'Celikkan', 'Affiliation': 'Department of Histology and Embryology, Laboratory for Stem Cells and Reproductive Cell Biology, Ankara University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Department of Biostatistics, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Sucu', 'Affiliation': 'Ankara University Biotechnology Institute and Sisbiyotek, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Toru', 'Affiliation': 'Radiology Division, Ankara Liv Hospital, Ankara, Turkey.'}, {'ForeName': 'Serdar Savas', 'Initials': 'SS', 'LastName': 'Gul', 'Affiliation': 'Visart Medical Imaging Center, Ankara, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Cinar', 'Affiliation': 'Department of Histology and Embryology, Laboratory for Stem Cells and Reproductive Cell Biology, Ankara University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Alp', 'Initials': 'A', 'LastName': 'Can', 'Affiliation': 'Department of Histology and Embryology, Laboratory for Stem Cells and Reproductive Cell Biology, Ankara University Faculty of Medicine, Ankara, Turkey.'}]",International journal of stem cells,['10.15283/ijsc20075']
2160,32840297,Blood pressure and brain injury in cardiac surgery: a secondary analysis of a randomized trial.,"OBJECTIVES


Brain dysfunction is a serious complication after cardiac surgery. In the Perfusion Pressure Cerebral Infarcts trial, we allocated cardiac surgery patients to a mean arterial pressure of either 70-80 or 40-50 mmHg during cardiopulmonary bypass (CPB). In this secondary analysis, we compared selected cerebral metabolites using magnetic resonance spectroscopy hypothesizing that a postoperative decrease in occipital grey matter (GM) N-acetylaspartate-to-total-creatine ratio, indicative of ischaemic injury, would be found in the high-target group.
METHODS


Of the 197 patients randomized in the Perfusion Pressure Cerebral Infarcts trial, 55 and 42 patients had complete and useful data from GM and white matter (WM), respectively. Spectroscopies were done preoperatively and on postoperative days 3-6. Cognitive function was assessed prior to surgery, at discharge and at 3 months. We predefined the statistical significance level to be 0.01.
RESULTS


A postoperative decrease was found in GM N-acetylaspartate-to-total-creatine ratio in the high-target group [mean difference -0.09 (95% confidence interval -0.14 to -0.04), P = 0.014]. No significant differences were found in other metabolite ratios investigated in GM or WM. No significant association was found between changes in metabolite ratios and new cerebral infarcts, WM lesion score or cognitive dysfunction.
CONCLUSIONS


A higher mean arterial pressure during CPB was associated with signs of impaired cerebral metabolism, though not at the predefined significance level of 0.01. No significant association was found between metabolite ratio changes and neuroradiological pathology or change in cognitive function.
CLINICAL TRIAL REGISTRATION NUMBER


Clinicaltrials.gov: NCT02185885.",2020,"A higher mean arterial pressure during CPB was associated with signs of impaired cerebral metabolism, though not at the predefined significance level of 0.01.","['cardiac surgery', 'cardiac surgery patients to a mean arterial pressure of either 70-80 or 40-50\u2009mmHg during cardiopulmonary bypass (CPB', 'Of the 197 patients randomized in the Perfusion Pressure Cerebral Infarcts trial, 55 and 42 patients had complete and useful data from GM and white matter (WM), respectively']",[],"['metabolite ratios and new cerebral infarcts, WM lesion score or cognitive dysfunction', 'GM N-acetylaspartate-to-total-creatine ratio', 'Blood pressure and brain injury', 'Cognitive function', 'metabolite ratio changes and neuroradiological pathology or change in cognitive function', 'occipital grey matter (GM) N-acetylaspartate-to-total-creatine ratio, indicative of ischaemic injury', 'metabolite ratios', 'mean arterial pressure']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C2752009', 'cui_str': 'White matter lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",197.0,0.331603,"A higher mean arterial pressure during CPB was associated with signs of impaired cerebral metabolism, though not at the predefined significance level of 0.01.","[{'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Vedel', 'Affiliation': 'Department of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Holmgaard', 'Affiliation': 'Department of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Else R', 'Initials': 'ER', 'LastName': 'Danielsen', 'Affiliation': 'Department of Radiology, Diagnostic Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Langkilde', 'Affiliation': 'Department of Radiology, Diagnostic Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Olaf B', 'Initials': 'OB', 'LastName': 'Paulson', 'Affiliation': 'Neurobiology Research Unit, Neuroscience Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne B', 'Initials': 'HB', 'LastName': 'Ravn', 'Affiliation': 'Department of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia, Center of Head and Orthopedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa216']
2161,32840319,Dental arch changes comparison between expander with differential opening and fan-type expander: a randomized controlled trial.,"OBJECTIVES


To compare posterior crossbite correction frequency and dentoalveolar changes of the expander with differential opening (EDO) and the fan-type expander (FE).
TRIAL DESIGN


Two-arm parallel randomized controlled trial.
METHODS


Forty-eight patients from 7 to 11 years of age were allocated into two groups. Twenty-four patients were treated with the EDO and 24 patients were treated with the FE. Block randomization was performed. The study was single blind. Digital dental models were acquired before treatment and 6 months after rapid maxillary expansion. The primary outcomes were crossbite correction rate and maxillary arch width changes. Secondary outcomes were interincisal diastema, arch perimeter, length, size and shape, and mandibular dental arch changes.
RESULTS


The final sample comprised 24 patients (13 female and 11 male; mean initial age of 7.62 years) in the EDO group and 24 patients (14 female and 10 male; mean initial age of 7.83 years) in the FE group. The crossbites were corrected in 100 per cent of subjects from EDO group and in 75 per cent of patients in FE group. EDO showed greater increases in maxillary intermolar region (P < 0.001), while the FE demonstrated greater increases in the intercanine distance (P = 0.008). Increase in mandibular inter-first permanent molar distance was slightly greater in the EDO group (mean difference of 0.8 mm). Changes in arch length and perimeter were similar in both groups. Both expanders changed the maxillary arch shape. The post-treatment arch shape was larger in the anterior region for FE and in the posterior region in the EDO group.
HARMS


Discomfort during activation was reported by 54 per cent of the participants. A temporary change in the nasal bridge was reported by one patient from FE group.
CONCLUSIONS


Maxillary arch width and shape changes were distinct between the EDO and the FE. Greater transversal increases of the anterior and posterior regions were observed for the FE and the EDO, respectively. A slightly greater mandibular spontaneous expansion was observed for the EDO only at the molar region.
TRIAL REGISTRATION


NCT03705871.",2020,"The post-treatment arch shape was larger in the anterior region for FE and in the posterior region in the EDO group.
","['24 patients (13 female and 11 male; mean initial age of 7.62 years) in the EDO group and 24 patients (14 female and 10 male; mean initial age of 7.83 years) in the FE group', 'Forty-eight patients from 7 to 11 years of age']","['expander with differential opening (EDO) and the fan-type expander (FE', 'expander with differential opening and fan-type expander', 'FE']","['maxillary intermolar region', 'intercanine distance', 'mandibular spontaneous expansion', 'nasal bridge', 'crossbite correction rate and maxillary arch width changes', 'Increase in mandibular inter-first permanent molar distance', 'interincisal diastema, arch perimeter, length, size and shape, and mandibular dental arch changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441039', 'cui_str': 'Fan'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0441039', 'cui_str': 'Fan'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0225408', 'cui_str': 'Structure of dorsum of nose'}, {'cui': 'C0242385', 'cui_str': 'Crossbite'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011998', 'cui_str': 'Diastema of teeth'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0011325', 'cui_str': 'Dental arch structure'}]",24.0,0.0511267,"The post-treatment arch shape was larger in the anterior region for FE and in the posterior region in the EDO group.
","[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Massaro', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Janson', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Miranda', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Aliaga-Del Castillo', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pugliese', 'Affiliation': 'Department of Orthodontics, School of Dental Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'José Roberto Pereira', 'Initials': 'JRP', 'LastName': 'Lauris', 'Affiliation': 'Department of Public Health, Bauru Dental School, University of São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Garib', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.'}]",European journal of orthodontics,['10.1093/ejo/cjaa050']
2162,32840337,"A comparison of the efficacy and tolerability of treating primary nocturnal enuresis with Solifenacin Plus Desmopressin, Tolterodine Plus Desmopressin, and Desmopressin alone: a randomized controlled clinical trial.","INTRODUCTION


Nocturnal enuresis (enuresis) is one of the most common developmental problems of childhood, which has often a familial basis, causes mental and psychological damage to the child and disrupts family solace.
OBJECTIVES


In this study, we compared therapeutic efficacy and tolerability of treating primary nocturnal enuresis (PNE) with solifenacin plus desmopressin, tolterodine plus desmopressin, and desmopressin alone. Because we don't have enough information about this comparison especially about solifenacin plus desmopressin.
PATIENTS AND METHODS


This clinical trial study was performed on 62 patients with enuresis aged 5-15 years who referred to the urology clinic of Imam Khomeini Hospital in Ahwaz in 2017-2018. Patients were randomly assigned to one of the three different therapeutic protocols and any participants were given a specific code. After that, we compared the therapeutic response and the level of satisfaction of each therapeutic group in different months. Data were analyzed using SPSS 22 software and descriptive and analytical statistics.
RESULTS


The mean age of patients was 8.70±66 years. In the therapeutic group with desmopressin and solifenacin, 19 of 20 patients (95%) achieved complete remission (1) after a 3-month treatment in comparison with monotherapy group in which 14 of 22 patients (63.63%) achieved complete remission; and in the combination therapy group of desmopressin and tolterodine, in the study and the evaluation of the consequences of 3-month treatment of this group, it was found that 17 of 20 patients (85%) had complete remission. Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone.
CONCLUSION


Our results demonstrate that the combination of desmopressin and an anticholinergic agent is highly effective in treatment of children with PMNE. Although desmopressin has long been a first - line treatment for PMNE, desmopressin monotherapy often fails to achieve a successful response in patients with PMNE.",2020,"Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone.
","['62 patients with enuresis aged 5-15 years who referred to the urology clinic of Imam Khomeini Hospital in Ahwaz in 2017-2018', 'patients with PMNE', 'Nocturnal enuresis (enuresis', 'children with PMNE']","['desmopressin and solifenacin', 'Solifenacin Plus Desmopressin, Tolterodine Plus Desmopressin, and Desmopressin alone', 'desmopressin', 'solifenacin plus desmopressin, tolterodine plus desmopressin, and desmopressin alone', 'anticholinergic agent', 'desmopressin and tolterodine', 'desmopressin plus anticholinergic']","['therapeutic efficacy and tolerability', 'therapeutic response', 'efficacy and tolerability', 'therapeutic response and the level of satisfaction', 'complete remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",62.0,0.0172601,"Overall, the therapeutic response in combination therapy groups of desmopressin plus anticholinergic was higher than the monotherapy group of desmopressin alone.
","[{'ForeName': 'Parvin Mousavi', 'Initials': 'PM', 'LastName': 'Ghanavati', 'Affiliation': 'Golestan Hospital, Iran, Tehran, Republic of Islamic.'}, {'ForeName': 'Dinyar', 'Initials': 'D', 'LastName': 'Khazaeli', 'Affiliation': 'Ahvaz Jundishapur University, Ahvaz, Khuzestan, Iran, Tehran, Republic of Islamic.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Amjadzadeh', 'Affiliation': 'Ahvaz Jundishapur University, Ahvaz, Khuzestan, Iran, Tehran, Republic of Islamic.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0448']
2163,32840412,Oral antibiotics used in the treatment of chronic rhinosinusitis have limited penetration into the sinonasal mucosa: a randomized trial.,"Despite the widespread prescription of antibiotics for patients with chronic rhinosinusitis (CRS), the extent to which drug distribution to the sinonasal mucosa occurs remains largely undefined.Twenty subjects undergoing functional endoscopic sinus surgery (FESS) for CRS were randomized to one of two groups: 1) doxycycline (100 mg daily for seven days) 2) roxithromycin (300 mg daily for seven days). Drug levels were measured using liquid chromatography-tandem mass spectrometry in sinonasal mucus, sinonasal tissues and serum at steady state.Doxycycline concentrations measured in the mucus were significantly lower compared to that in the serum (mean mucus/serum ratio =0.16, p < 0.001) and the tissue (mean mucus/tissue ratio =0.18, p < 0.0001). Roxithromycin concentrations in the mucus were also significantly lower compared to that in the serum (mean mucus/serum ratio =0.37, p = 0.002) and the tissue (mean mucus/tissue ratio =0.60, p < 0.001).Although the efficacy of doxycycline and roxithromycin in sinonasal mucus in vivo cannot be predicted solely from reported minimum inhibitory concentrations, given the added complexity of bacterial biofilm antimicrobial tolerance, these results suggest that low mucosal penetration of antibiotics may be one of the factors contributing to the limited efficacy of these agents in the treatment of CRS.",2020,"Doxycycline concentrations measured in the mucus were significantly lower compared to that in the serum (mean mucus/serum ratio =0.16, p < 0.001) and the tissue (mean mucus/tissue ratio =0.18, p < 0.0001).","['Twenty subjects undergoing functional endoscopic sinus surgery (FESS) for CRS', 'patients with chronic rhinosinusitis (CRS']","['roxithromycin', 'Oral antibiotics', 'doxycycline']","['Drug levels', 'Doxycycline concentrations', 'Roxithromycin concentrations']","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}]","[{'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C1261153', 'cui_str': 'Drug level'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}]",,0.0192049,"Doxycycline concentrations measured in the mucus were significantly lower compared to that in the serum (mean mucus/serum ratio =0.16, p < 0.001) and the tissue (mean mucus/tissue ratio =0.18, p < 0.0001).","[{'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Siu', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Klingler', 'Affiliation': 'Research and Development, Zenith Technology Corporation Limited, Dunedin, New Zealand.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Research and Development, Zenith Technology Corporation Limited, Dunedin, New Zealand.'}, {'ForeName': 'Cheung-Tak', 'Initials': 'CT', 'LastName': 'Hung', 'Affiliation': 'Research and Development, Zenith Technology Corporation Limited, Dunedin, New Zealand.'}, {'ForeName': 'Soo Hee', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'Department of Pharmacology and Clinical Pharmacology, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Labtests, Auckland, New Zealand.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Tingle', 'Affiliation': 'Department of Pharmacology and Clinical Pharmacology, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Wagner Mackenzie', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Douglas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}]",Xenobiotica; the fate of foreign compounds in biological systems,['10.1080/00498254.2020.1814973']
2164,32840417,Randomized Comparison of Pazopanib and Doxorubicin as First-Line Treatment in Patients With Metastatic Soft Tissue Sarcoma Age 60 Years or Older: Results of a German Intergroup Study.,"PURPOSE


Doxorubicin is a standard of care in patients with advanced, inoperable soft tissue sarcoma (STS). We tested whether pazopanib has efficacy comparable to that of doxorubicin in elderly patients with STS and offers superior tolerability for hematologic toxicity.
PATIENTS AND METHODS


Patients age 60 years or older without previous systemic treatment for progressive advanced or metastatic STS who had Eastern Cooperative Oncology Group performance status of 0 to 2 and adequate organ function were included. Treatment consisted of pazopanib 800 mg once per day or doxorubicin 75 mg/m 2  once every 3 weeks (≤ 6 cycles) after being randomly assigned in a 2:1 ratio. Noninferiority was assumed for progression-free survival (PFS), if the upper limit of the 95% CI for the hazard ratio (HR) was less than 1.8. Neutropenia and febrile neutropenia were key secondary end points. The European Organisation for Research and Treatment of Cancer (30-item) Quality of Life Questionnaire and geriatric assessment were used to measure patient-reported outcomes. Cox regression analysis and Kaplan-Meier curves were used for analysis.
RESULTS


Pazopanib and doxorubicin were given to 81 and 39 patients, respectively. The median age was 71 years (range, 60-88 years). PFS was noninferior (HR, 1.00; 95% CI, 0.65 to 1.53) and the incidence of grade 4 neutropenia and febrile neutropenia favored pazopanib. Objective response rates for pazopanib and doxorubicin were 12.3% and 15.4%, respectively. Overall survival did not differ significantly between arms (HR, 1.08; 95% CI, 0.68 to 1.72;  P  = .735). Geriatric assessment revealed 2 or more comorbidities in 15.8% of the patients and impairment of activities of daily living in 28.3% of patients.
CONCLUSION


Pazopanib was noninferior to doxorubicin, rendering pazopanib a putative therapeutic option in the first-line treatment of STS in patients age 60 years or older. The distinct adverse event profile may be used to counsel patients and tailor therapy to individual needs.",2020,"Overall survival did not differ significantly between arms (HR, 1.08; 95% CI, 0.68 to 1.72;  P  = .735).","['60 Years or Older', 'patients age 60 years or older', 'The median age was 71 years (range, 60-88 years', 'Patients age 60 years or older without previous systemic treatment for progressive advanced or metastatic STS who had Eastern Cooperative Oncology Group performance status of 0 to 2 and adequate organ function were included', 'elderly patients with STS', 'Patients With Metastatic Soft Tissue Sarcoma Age', 'patients with advanced, inoperable soft tissue sarcoma (STS']","['Pazopanib and doxorubicin', 'pazopanib 800 mg once per day or doxorubicin', 'Pazopanib', 'doxorubicin', 'pazopanib', 'pazopanib and doxorubicin', 'doxorubicin, rendering pazopanib', 'Pazopanib and Doxorubicin', 'Doxorubicin']","['Cancer (30-item) Quality of Life Questionnaire and geriatric assessment', 'Overall survival', 'activities of daily living', 'Neutropenia and febrile neutropenia', 'incidence of grade 4 neutropenia and febrile neutropenia', 'PFS', 'Objective response rates', 'progression-free survival (PFS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.104663,"Overall survival did not differ significantly between arms (HR, 1.08; 95% CI, 0.68 to 1.72;  P  = .735).","[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Karch', 'Affiliation': 'Institute for Biostatistics, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'Helios Clinic, Berlin, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert Bosch Centrum für Tumorerkrankungen Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Clinic for Internal Medicine (Tumor Research), University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kasper', 'Affiliation': 'Sarcoma Unit, Mannheim University Medical Center, Mannheim, Germany.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lindner', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Jens-Marcus', 'Initials': 'JM', 'LastName': 'Chemnitz', 'Affiliation': 'Community Hospital Middle Rine, Middle Rine, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crysandt', 'Affiliation': 'University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'University Hospital Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Steffen', 'Affiliation': 'University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': 'University Hospital Carl Gustav Carus, University Cancer Center/Medical Department I, Dresden, Germany.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Egerer', 'Affiliation': 'University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ivanyi', 'Affiliation': 'Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Zimmermann', 'Affiliation': 'Hannover Clinical Trial Center, Hannover, Germany.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute for Biostatistics, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Kunitz', 'Affiliation': 'Vivantes Clinic Berlin-Spandau, Berlin-Spandau, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00714']
2165,32840418,"Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma.","PURPOSE


To investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo.
PATIENTS AND METHODS


Patients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to rucaparib (600 mg twice per day) or placebo. QA-PFS was calculated as progression-free survival function × the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) index score function. Q-TWiST analyses were performed defining TOX as the mean duration in which a patient experienced grade ≥ 3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade ≥ 2 TEAEs of nausea, vomiting, fatigue, and asthenia. Q-TWiST was calculated as μTOX × TOX + TWiST, with μTOX calculated using EQ-5D-3L data.
RESULTS


The visit cutoff was Apr 15, 2017. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  BRCA -mutant cohort (130 rucaparib  v  66 placebo; 9.37 months [95% CI, 6.65 to 11.85 months]); homologous recombination deficient (HRD) cohort (236 rucaparib  v  118 placebo; 7.93 months [95% CI, 5.93 to 9.53 months]); and  BRCA  wild-type/loss of heterozygosity (LOH) low patient subgroup (107 rucaparib  v  54 placebo; 2.71 months [95% CI, 0.31 to 4.44 months]). With TOX defined using grade ≥ 3 TEAEs, the difference in mean Q-TWiST (rucaparib  v  placebo) was 6.88 months (95% CI, 5.71 to 8.23 months), 9.73 months (95% CI, 7.10 to 11.94 months), 8.11 months (95% CI, 6.36 to 9.49 months), and 3.35 months (95% CI, 1.66 to 5.40 months) in the ITT population,  BRCA -mutant cohort, HRD cohort, and  BRCA  wild-type/LOH low patient subgroup, respectively. Q-TWiST with TOX defined using select grade ≥ 2 TEAEs also consistently favored rucaparib.
CONCLUSION


The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib versus placebo in all predefined cohorts.",2020,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","['Patients With Recurrent Ovarian Carcinoma', 'Patients with platinum-sensitive, recurrent ovarian carcinoma']","['Rucaparib Maintenance Treatment', 'rucaparib versus placebo', 'placebo', 'rucaparib', 'Placebo']","['quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST', 'nausea, vomiting, fatigue, and asthenia', 'Mean QA-PFS', 'mean Q-TWiST', 'QA-PFS', 'EQ-5D questionnaire (EQ-5D-3L) index score function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.300562,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","[{'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Oncology Center of Galicia, Doctor Camilo Veiras, La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane and Women's Hospital and University of Queensland, St Lucia, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University, James Cancer Center, Columbus, OH.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': 'Modus Outcomes, Lyon, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clovis Oncology UK, Ltd., Cambridge, United Kingdom.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Mörk', 'Affiliation': 'Clovis Oncology Denmark, ApS, Copenhagen, Denmark.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bedel', 'Affiliation': 'Clovis Oncology Switzerland, GmBH, Zurich, Switzerland.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, and UCL Hospitals, London, United Kingdom.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03107']
2166,32840419,Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial.,"PURPOSE


To report the long-term results of external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT) Florence phase III trial comparing whole-breast irradiation (WBI) to APBI in early-stage breast cancer.
PATIENTS AND METHODS


The primary end point was to determine the 5-year difference in ipsilateral breast tumor recurrence (IBTR) between 30 Gy in 5 once-daily fractions (APBI arm) and 50 Gy in 25 fractions with a tumor bed boost (WBI arm) after breast-conserving surgery.
RESULTS


Five hundred twenty patients, more than 90% of whom had characteristics associated with low recurrence risk, were randomly assigned (WBI, n = 260; APBI, n = 260) between 2005 and 2013. Median follow-up was 10.7 years. The 10-year cumulative incidence of IBTR was 2.5% (n = 6) in the WBI and 3.7% (n = 9) in the APBI arm (hazard ratio [HR], 1.56; 95% CI, 0.55 to 4.37;  P  = .40). Overall survival at 10 years was 91.9% in both arms (HR, 0.95; 95% CI, 0.50 to 1.79;  P  = .86). Breast cancer-specific survival at 10 years was 96.7% in the WBI and 97.8% in the APBI arm (HR, 0.65; 95% CI, 0.21 to 1.99;  P  = .45). The APBI arm showed significantly less acute toxicity ( P  = .0001) and late toxicity ( P  = .0001) and improved cosmetic outcome as evaluated by both physician ( P  = .0001) and patient ( P  = .0001).
CONCLUSION


The 10-year cumulative IBTR incidence in early breast cancer treated with external APBI using IMRT technique in 5 once-daily fractions is low and not different from that after WBI. Acute and late treatment-related toxicity and cosmesis outcomes were significantly in favor of APBI.",2020,"The APBI arm showed significantly less acute toxicity ( P  = .0001) and late toxicity ( P  = .0001) and improved cosmetic outcome as evaluated by both physician ( P  = .0001) and patient ( P  = .0001).
","['early-stage breast cancer', 'early breast cancer treated with', 'Five hundred twenty patients, more than 90% of whom had characteristics associated with low recurrence risk', 'Early Breast Cancer']","['Accelerated Partial-Breast Irradiation', 'external APBI using IMRT technique', 'whole-breast irradiation (WBI) to APBI', 'external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT', 'Whole-Breast Irradiation']","['toxicity and cosmesis outcomes', '10-year cumulative incidence of IBTR', 'Overall survival', '10-year cumulative IBTR incidence', 'late toxicity', 'acute toxicity', 'Breast cancer-specific survival', 'cosmetic outcome', '5-year difference in ipsilateral breast tumor recurrence (IBTR']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C3896696', 'cui_str': 'Accelerated partial breast irradiation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}]",260.0,0.233567,"The APBI arm showed significantly less acute toxicity ( P  = .0001) and late toxicity ( P  = .0001) and improved cosmetic outcome as evaluated by both physician ( P  = .0001) and patient ( P  = .0001).
","[{'ForeName': 'Icro', 'Initials': 'I', 'LastName': 'Meattini', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Marrazzo', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Calogero', 'Initials': 'C', 'LastName': 'Saieva', 'Affiliation': 'Istituto per lo Studio la Prevenzione e la Rete Oncologica (ISPRO), Florence, Italy.'}, {'ForeName': 'Isacco', 'Initials': 'I', 'LastName': 'Desideri', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Vieri', 'Initials': 'V', 'LastName': 'Scotti', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Simontacchi', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Bonomo', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Greto', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Mangoni', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Scoccianti', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lucidi', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Paoletti', 'Affiliation': 'Ospedale Santa Maria Annunziata-Azienda Usl Toscana Centro, Florence, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Fambrini', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bernini', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sanchez', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Orzalesi', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Nori', 'Affiliation': 'Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Bianchi', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Pallotta', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Livi', 'Affiliation': 'University of Florence, Florence, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00650']
2167,32840458,Evaluation of single session physical therapy methods in bruxism patients using shear wave ultrasonography.,"OBJECTIVE


To compare the immediate effects of a single session of manual therapy (MT) or Kinesio taping following MT (KTMT) in patients with bruxism using shear wave ultrasonography.
METHODS


Twenty patients were included in the MT group (mean age 27.3 ± 4.8), and 19 patients were included in the KTMT group (age mean 26.2 ± 5.4), randomly. Muscle thickness and stiffness were assessed via shear wave ultrasonography, and pain pressure threshold was assessed with an algometer before and after one session of MT or KTMT.
RESULTS


Significant decreases were found in muscle thickness and stiffness of the bilateral masseter (p < 0.05). Significant decrease in pain was seen in the masseter and temporalis muscle PPT measurements in the KTMT group (p < 0.05) only.
CONCLUSION


Kinesio taping in addition to MT is recommended in the immediate physiotherapy treatment of bruxism for acute pain.",2020,"Significant decrease in pain was seen in the masseter and temporalis muscle PPT measurements in the KTMT group (p < 0.05) only.
","['Twenty patients were included in the MT group (mean age 27.3 ± 4.8), and 19 patients were included in the KTMT group (age mean 26.2 ± 5.4), randomly', 'bruxism patients using shear wave ultrasonography', 'patients with bruxism using shear wave ultrasonography']","['Kinesio taping', 'manual therapy (MT) or Kinesio taping following MT (KTMT']","['Muscle thickness and stiffness were assessed via shear wave ultrasonography, and pain pressure threshold', 'pain', 'muscle thickness and stiffness of the bilateral masseter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0006325', 'cui_str': 'Grinding teeth'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}]",20.0,0.0738875,"Significant decrease in pain was seen in the masseter and temporalis muscle PPT measurements in the KTMT group (p < 0.05) only.
","[{'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'Nihan', 'Initials': 'N', 'LastName': 'Kafa', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'Mehmet Eray', 'Initials': 'ME', 'LastName': 'Kolsuz', 'Affiliation': 'Faculty of Dentistry, Department of Dentomaxillofacial Radiology, Ankara University , Ankara, Turkey.'}, {'ForeName': 'Melek', 'Initials': 'M', 'LastName': 'Volkan-Yazici', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Yuksek Ihtisas University , Ankara, Turkey.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Evli', 'Affiliation': 'Faculty of Dentistry, Department of Dentomaxillofacial Radiology, Ankara University , Ankara, Turkey.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Orhan', 'Affiliation': 'Faculty of Dentistry, Department of Dentomaxillofacial Radiology, Ankara University , Ankara, Turkey.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1812817']
2168,32840489,Recruiting Student Health Coaches to Improve Digital Blood Pressure Management: Randomized Controlled Pilot Study.,"BACKGROUND


Hypertension is a significant problem in the United States, affecting 1 in 3 adults aged above 18 years and is associated with a higher risk for cardiovascular disease and stroke. The prevalence of hypertension has increased in medically underserved areas (MUAs). Mobile health technologies, such as digital self-monitoring devices, have been shown to improve the management of chronic health conditions. However, patients from MUAs have reduced access to these devices because of limited resources and low health literacy. Health coaches and peer training programs are a potentially cost-effective solution for the shortage of physicians available to manage hypertension in MUAs. Activating young people as student health coaches (SHCs) is a promising strategy to improve community health.
OBJECTIVE


This pilot study aims to assess (1) the feasibility of training high school students as health technology coaches in MUAs and (2) whether the addition of SHCs to digital home monitoring improves the frequency of self-monitoring and overall blood pressure (BP) control.
METHODS


In total, 15 high school students completed 3-day health coach training. Patients who had a documented diagnosis of hypertension were randomly assigned to 1 of the 3 intervention arms. The QardioArm alone (Q) group was provided a QardioArm cuff only for convenience. The SHC alone (S) group was instructed to meet with a health coach for 30 min once a week for 5 weeks to create action plans for reducing BP. The student+QardioArm (S+Q) group received both interventions.
RESULTS


Participants (n=27) were randomly assigned to 3 groups in a ratio of 9:9:9. All 15 students completed training, of which 40% (6/15) of students completed all the 5 meetings with their assigned patient. Barriers to feasibility included transportation and patient response drop-off at the end of the study. Overall, 92% (11/12) of the students rated their experience as very good or higher and 69% (9/13) reported that this experience made them more likely to go into the medical field. There was a statistically significant difference in the frequency of cuff use (S+Q vs Q groups: 37 vs 17; P<.001). Participants in the S+Q group reported better BP control after the intervention compared with the other groups. The average BP at the end of the intervention was 145/84 (SD 9/18) mm Hg, 150/85 (SD 18/12) mm Hg, and 128/69 (SD 20/14) mm Hg in the Q, S, and S+Q groups, respectively.
CONCLUSIONS


This pilot study demonstrates the feasibility of pairing technology with young student coaches, although challenges existed. The S+Q group used their cuff more than the Q group. Patients were more engaged in the S+Q group, reporting higher satisfaction with their SHC and better control of their BP.",2020,"Mobile health technologies, such as digital self-monitoring devices, have been shown to improve the management of chronic health conditions.","['school students as health technology coaches in MUAs and (2', 'Patients who had a documented diagnosis of hypertension', 'Participants (n=27', 'young student coaches', 'Activating young people as student health coaches (SHCs', '3 adults aged above 18 years', '15 high school students completed', 'All 15 students completed training, of which 40% (6/15) of students completed all the 5 meetings with their assigned patient']","['Digital Blood Pressure Management', '3-day health coach training', 'S+Q']","['average BP', 'BP control', 'frequency of cuff use', 'prevalence of hypertension', 'frequency of self-monitoring and overall blood pressure (BP) control']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0752189', 'cui_str': 'Health Care Technology'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4301973', 'cui_str': 'Average blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",15.0,0.0622547,"Mobile health technologies, such as digital self-monitoring devices, have been shown to improve the management of chronic health conditions.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vasti', 'Affiliation': 'University of California, San Francisco School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of California, San Francisco, San Francisco, CA, United States.'}]",JMIR formative research,['10.2196/13637']
2169,32840572,Metabolic Availability of Lysine in Milk and a Vegetarian Cereal-Legume Meal Determined by the Indicator Amino Acid Oxidation Method in Indian Men.,"BACKGROUND


Lysine rich foods such as milk and legumes serve as important food additions to the lysine deficient cereal-based diets of vegetarian populations in low- and middle-income countries (LMICs) to alleviate the risk of quality corrected dietary protein inadequacy. Dietary protein quality can be determined by estimating the metabolic availability (MA) of lysine.
OBJECTIVES


The study aimed to estimate the MA of lysine in spray-dried cow milk powder (SMP), heat-treated spray-dried cow milk powder (HSMP), and a habitually consumed cereal-legume based vegetarian meal (VM), using the indicator amino acid oxidation (IAAO) slope-ratio method.
METHODS


The MA of lysine in SMP, HSMP, and VM was estimated in 7 healthy young men aged 19-24 y with BMI of 21.5 ± 0.5 kg/m2 in a repeated measures design. The IAAO response slopes with 2 graded lysine intakes (10.5 and 15.0 mg·kg-1·d-1) from the SMP and VM were compared with the response slope generated with 3 graded crystalline lysine intakes (6.0, 10.5, and 15.0 mg·kg-1·d-1) at the subrequirement level. To produce HSMP, pasteurized cow milk was heat treated and spray dried. The MA of lysine in HSMP was tested at a single level of lysine intake (15 mg·kg-1·d-1). A total of 8 IAAO experiments were conducted on each participant in randomized order. The IAAO slopes were estimated using a linear mixed-effect regression model.
RESULTS


The MA of lysine in SMP, HSMP, and VM was 91.9%, 69.9%, and 86.6% respectively.
CONCLUSIONS


Heat treatment reduced the MA of lysine by 22% in HSMP compared with SMP in healthy Indian adults. The lysine MA estimates can be used to optimize lysine limited cereal-based diets, with the addition of appropriately processed legumes and milk powder, to meet the protein requirement. This trial was registered at Clinical Trials Registry of India (http://ctri.nic.in) as CTRI/2019/08/020568.",2020,"The IAAO response slopes with 2 graded lysine intakes (10.5 and 15.0 mg·kg-1·d-1) from the SMP and VM were compared with the response slope generated with 3 graded crystalline lysine intakes (6.0, 10.5, and 15.0 mg·kg-1·d-1) at the subrequirement level.","['7 healthy young men aged 19-24 y with BMI of 21.5\xa0±\xa00.5\xa0kg/m2 in a repeated measures design', 'healthy Indian adults', 'Indian Men']","['SMP', 'HSMP', 'MA of lysine in spray-dried cow milk powder (SMP), heat-treated spray-dried cow milk powder (HSMP), and a habitually consumed cereal-legume based vegetarian meal (VM', 'Lysine in Milk and a Vegetarian Cereal-Legume Meal']","['MA of lysine in SMP, HSMP, and VM', 'indicator amino acid oxidation (IAAO) slope-ratio method', 'MA of lysine', 'IAAO slopes', 'IAAO response slopes']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0452726', 'cui_str': ""Dried cow's milk""}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0023263', 'cui_str': 'Pea family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0452726', 'cui_str': ""Dried cow's milk""}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",7.0,0.0252093,"The IAAO response slopes with 2 graded lysine intakes (10.5 and 15.0 mg·kg-1·d-1) from the SMP and VM were compared with the response slope generated with 3 graded crystalline lysine intakes (6.0, 10.5, and 15.0 mg·kg-1·d-1) at the subrequirement level.","[{'ForeName': 'Sulagna', 'Initials': 'S', 'LastName': 'Bandyopadhyay', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kuriyan', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Shivakumar', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Santu', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': ""Department of Biostatistics, St. John's Medical College, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Rajendran', 'Initials': 'R', 'LastName': 'Ananthan', 'Affiliation': 'Food Chemistry Division, ICMR-National Institute of Nutrition, Jamai-Osmania, Hyderabad, India.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Devi', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Research Center of University of Mysore, St. John's National Academy of Health Sciences, Bengaluru, India.""}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St. John's Medical College, St. John's National Academy of Health Sciences, Bengaluru, India.""}]",The Journal of nutrition,['10.1093/jn/nxaa235']
2170,32840580,"Bioavailable Lysine, Assessed in Healthy Young Men Using Indicator Amino Acid Oxidation, is Greater when Cooked Millet and Stewed Canadian Lentils are Combined.","BACKGROUND


Pearl millet is the chief source of energy in the diet in some developing regions, but has a limited amount of indispensable amino acid lysine. Complementation with pulses like lentils can improve the protein quality of millet diets, but the knowledge of lysine bioavailability (BA) in millet and lentils is lacking.
OBJECTIVES


The study objectives were to determine the BA of lysine in millet and lentils separately and to assess the effect of complementation of millet and lentils in a mixed meal format.
METHODS


We studied 9 healthy young men (≤30 y; BMI <25) in a repeated-measure design using the indicator amino acid oxidation (IAAO) method, with L-[1-13C] phenylalanine as the indicator. Each subject completed 7 or 8 experiments in random order. On the reference diet, subjects received 4 graded levels of L-lysine (5, 8, 12, and 15 mg·kg-1.d-1) from a crystalline amino acid mixture patterned after egg protein; on the test diets, they received 3 levels of lysine (10, 12, and 15 mg·kg-1.d-1) from either steamed millet or stewed lentils; and on the complementation diet, they received 1 level of lysine from a mixed meal of steamed millet and stewed lentils. The BA of lysine and the effect of complementation were assessed by comparing the IAAO responses to the test diets and the complementation diet with the IAAO response to L-lysine intakes in the reference protein, using the slope ratio method.
RESULTS


The BA of lysine was 97% from millet and 80% from lentils. Complementation of steamed millet with stewed lentils decreased the oxidation of L-[1-13C] phenylalanine by 27% (P < 0.05), signifying improved quality of the combined millet and lentil protein.
CONCLUSIONS


Lysine has high BA but is still limiting in steamed pearl millet. Complementation with lentils in a 2:1 ratio is recommended to meet the lysine and protein requirements for adult men consuming a millet-based diet. This trial was registered at clinicaltrials.gov as NCT03674736 and NCT03339167.",2020,"Complementation of steamed millet with stewed lentils decreased the oxidation of L-[1-13C] phenylalanine by 27% (P < 0.05), signifying improved quality of the combined millet and lentil protein.
","['adult men consuming a millet-based diet', 'Healthy Young Men', '9 healthy young men (≤30 y; BMI\xa0<25']","['4 graded levels of L-lysine (5, 8, 12, and 15 mg·kg-1.d-1) from a crystalline amino acid mixture patterned after egg protein; on the test diets, they received 3 levels of lysine (10, 12, and 15 mg·kg-1.d-1) from either steamed millet or stewed lentils; and on the complementation diet, they received 1 level of lysine from a mixed meal of steamed millet and stewed lentils', 'indicator amino acid oxidation (IAAO) method, with L-[1-13C] phenylalanine', 'Bioavailable Lysine']","['oxidation of L-[1-13C] phenylalanine', 'BA of lysine', 'IAAO responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0937879', 'cui_str': 'Millet extract'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013700', 'cui_str': 'Egg protein'}, {'cui': 'C0452401', 'cui_str': 'Test diet'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0937879', 'cui_str': 'Millet extract'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]",9.0,0.0312511,"Complementation of steamed millet with stewed lentils decreased the oxidation of L-[1-13C] phenylalanine by 27% (P < 0.05), signifying improved quality of the combined millet and lentil protein.
","[{'ForeName': 'Abrar', 'Initials': 'A', 'LastName': 'Fakiha', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Zujaja', 'Initials': 'Z', 'LastName': 'Tul-Noor', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Paoletti', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Departments of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Levesque', 'Affiliation': 'Department of Animal Science, South Dakota State University, Brookings, SD, USA.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa227']
2171,32840597,Effect of Vitamin D3 Supplementation on Severe Asthma Exacerbations in Children With Asthma and Low Vitamin D Levels: The VDKA Randomized Clinical Trial.,"Importance


Severe asthma exacerbations cause significant morbidity and costs. Whether vitamin D3 supplementation reduces severe childhood asthma exacerbations is unclear.
Objective


To determine whether vitamin D3 supplementation improves the time to a severe exacerbation in children with asthma and low vitamin D levels.
Design, Setting, and Participants


The Vitamin D to Prevent Severe Asthma Exacerbations (VDKA) Study was a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to improve the time to severe exacerbations in high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers. Enrollment started in February 2016, with a goal of 400 participants; the trial was terminated early (March 2019) due to futility, and follow-up ended in September 2019.
Interventions


Participants were randomized to vitamin D3, 4000 IU/d (n = 96), or placebo (n = 96) for 48 weeks and maintained with fluticasone propionate, 176 μg/d (6-11 years old), or 220 μg/d (12-16 years old).
Main Outcomes and Measures


The primary outcome was the time to a severe asthma exacerbation. Secondary outcomes included the time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid was reduced halfway through the trial, and the cumulative fluticasone dose during the trial.
Results


Among 192 randomized participants (mean age, 9.8 years; 77 girls [40%]), 180 (93.8%) completed the trial. A total of 36 participants (37.5%) in the vitamin D3 group and 33 (34.4%) in the placebo group had 1 or more severe exacerbations. Compared with placebo, vitamin D3 supplementation did not significantly improve the time to a severe exacerbation: the mean time to exacerbation was 240 days in the vitamin D3 group vs 253 days in the placebo group (mean group difference, -13.1 days [95% CI, -42.6 to 16.4]; adjusted hazard ratio, 1.13 [95% CI, 0.69 to 1.85]; P = .63). Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial. Serious adverse events were similar in both groups (vitamin D3 group, n = 11; placebo group, n = 9).
Conclusions and Relevance


Among children with persistent asthma and low vitamin D levels, vitamin D3 supplementation, compared with placebo, did not significantly improve the time to a severe asthma exacerbation. The findings do not support the use of vitamin D3 supplementation to prevent severe asthma exacerbations in this group of patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT02687815.",2020,"Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial.","['children with asthma and low vitamin D levels', 'children with persistent asthma and low vitamin D levels', ' 77 girls [40%]), 180 (93.8%) completed the trial', '192 randomized participants (mean age, 9.8 years', 'Children With Asthma and Low Vitamin D Levels', 'high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers']","['Vitamin D', 'fluticasone propionate', 'vitamin D3', 'placebo', 'placebo, vitamin D3 supplementation', 'Vitamin D3 Supplementation', 'vitamin D3 supplementation', 'Vitamin D3 supplementation']","['severe childhood asthma exacerbations', 'Severe Asthma Exacerbations (VDKA', 'time to a severe exacerbation', 'time to a severe asthma exacerbation', 'Serious adverse events', 'Severe Asthma Exacerbations', 'mean time to exacerbation', 'severe exacerbations', 'time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid', 'time to severe exacerbations', 'time to a viral-induced severe exacerbation', 'severe asthma exacerbations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4285871', 'cui_str': 'Vitamin D low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",192.0,0.78948,"Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial.","[{'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Forno', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St Louis Children's Hospital, Washington University at St Louis, St Louis, Missouri.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Allergy and Immunology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Guilbert', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, University of California, San Francisco Benioff Children's Hospital, University of California, San Francisco.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Division of Pediatric Pulmonology, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, Ohio.""}, {'ForeName': 'Ronina', 'Initials': 'R', 'LastName': 'Covar', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, National Jewish Health, University of Colorado, Denver.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Gern', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison School of Medicine and Public Health, Madison.'}, {'ForeName': 'Franziska J', 'Initials': 'FJ', 'LastName': 'Rosser', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Blatter', 'Affiliation': ""Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St Louis Children's Hospital, Washington University at St Louis, St Louis, Missouri.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Yueh-Ying', 'Initials': 'YY', 'LastName': 'Han', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Celedón', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}]",JAMA,['10.1001/jama.2020.12384']
2172,32840598,Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial.,"Importance


After percutaneous coronary intervention (PCI), patients with CYP2C19*2 or *3 loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown.
Objective


To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes in CYP2C19 LOF carriers after PCI.
Design, Setting, and Participants


Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019.
Interventions


Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping. CYP2C19 LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months.
Main Outcomes and Measures


The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients with CYP2C19 LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50.
Results


Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 with CYP2C19 LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903 CYP2C19 LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02]; P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07]; P = .16).
Conclusions and Relevance


Among CYP2C19 LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months.
Trial Registration


ClinicalTrials.gov Identifier: NCT01742117.",2020,"None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58).","['CYP2C19 LOF carriers after PCI', 'patients with CYP2C19', '5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial', '5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD', 'Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019']","['conventional therapy received clopidogrel', 'percutaneous coronary intervention (PCI', 'oral P2Y12 inhibitor therapy', 'genotype-guided group (n\u2009=\u20092652) underwent point-of-care genotyping', 'Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy', 'clopidogrel', 'ticagrelor', 'genotype-guided oral P2Y12 inhibitor strategy']","['major or minor bleeding', 'cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia', 'Ischemic Outcomes', 'risk of ischemic events', 'ischemic outcomes', 'major or minor bleeding in CYP2C19 LOF carriers', 'composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia']","[{'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",5302.0,0.146849,"None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58).","[{'ForeName': 'Naveen L', 'Initials': 'NL', 'LastName': 'Pereira', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre and Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lennon', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Verghese', 'Initials': 'V', 'LastName': 'Mathew', 'Affiliation': 'Department of Medicine, Loyola University, Maywood, Illinois.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jang-Ho', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, Konyang University, Seo-gu, Taejon, South Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Heart Research Center, Chonnam National University, Gwangju, South Korea.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Chavez', 'Affiliation': 'Department of Cardiology, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gordon', 'Affiliation': 'Division of Cardiology, The Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'J Dawn', 'Initials': 'JD', 'LastName': 'Abbott', 'Affiliation': 'Division of Cardiology, Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cagin', 'Affiliation': 'Mayo Clinic Health System-La Crosse, La Crosse, Wisconsin.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Baudhuin', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yi-Ping', 'Initials': 'YP', 'LastName': 'Fu', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Iturriaga', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Sidhu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Albany Medical Center and Albany Medical College, Albany, New York.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Liewei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Weinshilboum', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'Department of Medicine, Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Charanjit', 'Initials': 'C', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}]",JAMA,['10.1001/jama.2020.12443']
2173,32840621,Effect of a Brief Mindfulness-Based Program on Stress in Health Care Professionals at a US Biomedical Research Hospital: A Randomized Clinical Trial.,"Importance


Stress among health care professionals is well documented. The use of mindfulness-based interventions to reduce stress has shown promising results; however, the time commitment of typical programs can be a barrier to successful implementation in health care settings.
Objective


To determine the efficacy and feasibility of a brief mindfulness-based program to reduce stress during work hours among health care professionals.
Design, Setting, and Participants


This intent-to-treat randomized clinical trial was conducted among full-time health care professionals at the Clinical Center at the National Institutes of Health in Bethesda, Maryland, between September 2017 and May 2018. Participants were randomized to receive mindfulness-based self-care (MBSC) training or life-as-usual control. Data were analyzed from June 2018 to January 2020.
Interventions


The MBSC intervention included 5 weekly, 1.5-hour in-class mindfulness practice sessions.
Main Outcomes and Measures


Stress level was the primary outcome, assessed with the Perceived Stress Scale 10-Item version. Secondary outcomes included anxiety, burnout, positive and negative affect, mindfulness (trait and state), and self-care. Assessments were taken at baseline and at the end of the intervention (week 5) in the intervention and control groups, and at follow-up (week 13) in the intervention group to test for a maintenance effect. A postprogram evaluation was also obtained.
Results


Of 82 randomized participants, 78 who completed the study at week 5 were included in the modified intent-to-treat analysis (median [interquartile range] age, 32 [23-48] years; 65 [83%] women), including 43 participants in the MBSC group and 35 participants in the control group. At the end of the intervention, compared with the control group, the MBSC group had reduced levels of stress (mean [SD] score, 17.29 [5.84] vs 18.54 [6.30]; P = .02) and anxiety (mean [SD] score, 2.58 [1.52] vs 4.23 [1.73]; P < .001), and improved positive affect (mean [SD] score, 35.69 [7.12] vs 31.42 [7.27]; P < .001), state mindfulness (mean [SD] score, 3.74 [1.18] vs 2.78 [1.16]; P < .001), and mindful self-care (mean [SD] score, 7.29 [2.44] vs 5.54 [2.77]; P < .001). Burnout, negative affect, and trait mindfulness levels did not differ between groups. Changes within the MBSC group through follow-up included sustained reductions in stress (change, -6.14; 95% CI, -7.84 to -4.44; P < .001), anxiety (change, -1.46; 95% CI, -1.97 to -0.94; P < .001), trait mindfulness (change, 0.63; 95% CI, 0.36 to 0.90; P < .001), and state mindfulness (change, 1.89; 95% CI, 1.39 to 2.39; P < .001).
Conclusions and Relevance


This randomized clinical trial found that this brief mindfulness-based intervention was an effective and feasible means to reduce stress in health care professionals. Larger studies are needed to assess the effects on clinical care and patient outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT03781336.",2020,"At the end of the intervention, compared with the control group, the MBSC group had reduced levels of stress (mean [SD] score, 17.29 [5.84] vs 18.54 [6.30]; P = .02) and anxiety (mean [SD] score, 2.58 [1.52] vs 4.23 [1.73]; P < .001), and improved positive affect (mean [SD] score, 35.69 [7.12] vs 31.42 [7.27]; P < .001), state mindfulness (mean [SD] score, 3.74 [1.18] vs 2.78 [1.16]; P < .001), and mindful self-care (mean [SD] score, 7.29 [2.44] vs 5.54 [2.77]; P < .001).","['full-time health care professionals at the Clinical Center at the National Institutes of Health in Bethesda, Maryland, between September 2017 and May 2018', 'Data were analyzed from June 2018 to January 2020', 'Health Care Professionals at a US Biomedical Research Hospital', '82 randomized participants, 78 who completed the study at week 5 were included in the modified intent-to-treat analysis (median [interquartile range] age, 32 [23-48] years; 65 [83%] women), including 43 participants in the MBSC group and 35 participants in the control group']","['MBSC', 'brief mindfulness-based program', 'mindfulness-based self-care (MBSC) training or life-as-usual control', 'Brief Mindfulness-Based Program']","['state mindfulness', 'trait mindfulness', 'mindful self-care', 'anxiety, burnout, positive and negative affect, mindfulness (trait and state), and self-care', 'Perceived Stress Scale 10-Item version', 'trait mindfulness levels', 'anxiety', 'levels of stress']","[{'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0005540', 'cui_str': 'Research, Biomedical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",82.0,0.110778,"At the end of the intervention, compared with the control group, the MBSC group had reduced levels of stress (mean [SD] score, 17.29 [5.84] vs 18.54 [6.30]; P = .02) and anxiety (mean [SD] score, 2.58 [1.52] vs 4.23 [1.73]; P < .001), and improved positive affect (mean [SD] score, 35.69 [7.12] vs 31.42 [7.27]; P < .001), state mindfulness (mean [SD] score, 3.74 [1.18] vs 2.78 [1.16]; P < .001), and mindful self-care (mean [SD] score, 7.29 [2.44] vs 5.54 [2.77]; P < .001).","[{'ForeName': 'Rezvan', 'Initials': 'R', 'LastName': 'Ameli', 'Affiliation': 'National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ninet', 'Initials': 'N', 'LastName': 'Sinaii', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'West', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Luna', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Samin', 'Initials': 'S', 'LastName': 'Panahi', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zoosman', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Rusch', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Clinical Center, National Institutes of Health, Bethesda, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.13424']
2174,32840716,The Evaluation of  68 Ga-Citrate PET/CT Imaging for Dihydroartemisinin in the Treatment of Rheumatoid Arthritis.,"PURPOSE


We aimed to use  68 Ga-citrate, a labeled product of gallium (iron analog), combined with positron emission tomography/computed tomography (PET/CT) to non-invasively evaluate the potential of the iron-responsive product dihydroartemisinin (DHA) in the treatment of rheumatoid arthritis.
PROCEDURES


From the establishment of chicken II collagen-induced arthritis (CIA) rat model over 40 days, 20 rats with one-to-one corresponding arthritis index (AI) scores were randomly divided into two groups. One group received oral DHA (at a dose of 1.5 ml/(kg day), containing 20 mg DHA per 1 ml) for 15 days; the other group received stroke-physiological saline solution (SSS, 1.5 ml/(kg day) for 15 days.  68 Ga-citrate micro-PET/CT imaging was performed on day 0 (D0), day 5 (D5), day 10 (D10), and day 15 (D15) of oral administration. After data reconstruction, the cross-sectional length ""d"" of the ankle joint of each rat was measured on the transverse CT, and the SUV max  of the ankle joint and muscle background was measured for statistical analysis. After micro-PET/CT collection, the ankle joint tissue was observed by HE staining.
RESULTS


The ankle joint swelling in the DHA group was significantly suppressed, but the SSS group showed no significant suppression.  68 Ga-citrate micro-PET/CT imaging results and microscope observation confirmed this finding. Statistical analysis indicated that the time tendency of AI score (B interaction  = 0.495, P < 0.001) and T/NT (B interaction  = 1.345, P < 0.001) were discrepant between DHA and SSS groups. The AI score and T/NT of the DHA group gradually increased with time, while the SSS group score gradually decreased. Furthermore, the Spearman correlation coefficient was used to describe the relationship between ""d"" and T/NT, which was positively correlated (r = 0.855, P < 0.001).
CONCLUSIONS


This study showed that the anti-inflammatory effect of the iron-responsive product DHA in arthritis can be monitored by an iron-like radioactive tracer ( 68 Ga-citrate).",2020,"Statistical analysis indicated that the time tendency of AI score (B interaction  = 0.495, P < 0.001) and T/NT (B interaction  = 1.345, P < 0.001) were discrepant between DHA and SSS groups.","['chicken II collagen-induced arthritis (CIA) rat model', '20 rats with one-to-one corresponding arthritis index (AI) scores']","['68 Ga-citrate, a labeled product of gallium (iron analog), combined with positron emission tomography/computed tomography (PET/CT', 'oral DHA', 'Citrate PET/CT Imaging for Dihydroartemisinin', 'iron-responsive product dihydroartemisinin (DHA', 'stroke-physiological saline solution (SSS', '68 Ga-citrate micro-PET/CT imaging', 'iron-responsive product DHA']","['ankle joint tissue', 'AI score and T/NT', 'time tendency of AI score', 'ankle joint swelling']","[{'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0971858', 'cui_str': 'Collagen Arthritis'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0576177', 'cui_str': 'Swelling of ankle joint'}]",20.0,0.0436913,"Statistical analysis indicated that the time tendency of AI score (B interaction  = 0.495, P < 0.001) and T/NT (B interaction  = 1.345, P < 0.001) were discrepant between DHA and SSS groups.","[{'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, Affiliated Hospital of Southwest Medical University/Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, Luzhou, Sichuan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Neurosurgery, Dazhou Central Hospital, Dazhou, Sichuan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Nuclear Medicine, Affiliated Hospital of Southwest Medical University/Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, Luzhou, Sichuan, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nuclear Medicine, Affiliated Hospital of Southwest Medical University/Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, Luzhou, Sichuan, China. chenyue5523@126.com.'}]",Molecular imaging and biology,['10.1007/s11307-020-01534-4']
2175,32840767,Better Treatment Values in Local Application of Tranexamic Acid (TXA) than Intravenous Application with the Same Dose in Total Hip Arthroplasty.,"INTRODUCTION


The aim of our study was to investigate the hemostatic effect of local and intravenously administered tranexamic acid (TXA) at the same dose in total hip arthroplasty.
METHODS


The prospective study included 72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019. The patients enrolled in the study were randomly divided into two groups: the observation group (36 patients were injected with 2.0 g TXA in 10 mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule) and the control group (36 patients were given an intravenous infusion of 2 g TXA in 200 mL 0.9% NaCl 30 min before the operation). In each patient, apparent blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion were compared between the two groups after treatment. Hematocrit (Hct) and hemoglobin (Hb) levels were recorded at postoperative day (POD) 1, 2, 3, 7, and 10. We also recorded the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) before the operation and 12 h postoperative and POD 1, 3, 7, and 10. The incidence of deep venous thrombosis and pulmonary embolism was also taken into account.
RESULTS


In the observation group, apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion were lower compared than the control group (P < 0.001). The levels of Hct and Hb were compared between the two groups at POD 1, 2, 3, 7, and 10, and the observation group reported higher levels of Hct and Hb (P < 0.001). The levels of CRP and IL-6 were compared between the two groups at POD 1, 3, 7, and 10, and the observation group reported lower levels of CRP and IL-6 than the control group (P < 0.001). On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
CONCLUSIONS


Local and intravenous applications of TXA at the same dose are effective approaches in terms of reducing bleeding and inflammatory reaction with a good safety profile; however, the effect of local application had superior therapeutic values.",2020,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
","['72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019', 'Total Hip Arthroplasty', 'total hip arthroplasty']","['intravenous infusion of 2\xa0g TXA', 'TXA in 10\xa0mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule', 'tranexamic acid (TXA', 'Tranexamic Acid (TXA', 'TXA']","['Hematocrit (Hct) and hemoglobin (Hb) levels', 'blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion', 'pulmonary embolism', 'hemostatic effect', 'levels of Hct and Hb', 'incidence of deep venous thrombosis', 'apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion', 'incidence of deep venous thrombosis and pulmonary embolism', 'levels of CRP and IL-6', 'levels of C-reactive protein (CRP) and interleukin-6 (IL-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0502723', 'cui_str': 'Structure of joint cavity'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",72.0,0.0284129,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
","[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Desi', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. panjiang@ccmu.edu.cn.'}]",Advances in therapy,['10.1007/s12325-020-01454-3']
2176,32840871,Fostering Self-Control Development With a Designed Intervention in Physical Education: A Two-Year Class-Randomized Trial.,"This study evaluated whether a theory-based intervention in physical education (PE) designed to train self-control may positively impact children's quick-temperedness and disruptiveness and whether changes in executive functions (EFs) may be a correlate or antecedent of such effects. One hundred and sixteen children aged 8-9 years participated in a 2-year intervention and completed three assessments at baseline, 6- and 18-month follow-ups in quick-temperedness and disruptiveness, hot and cool EFs. After the intervention, children in the intervention group showed lower quick-temperedness and disruptiveness and improvement in hot EF. Changes over the intervention period were moderately associated and showed marginal evidence of causal ordering, suggesting that designed PE may benefit self-control through a possible linkage to hot EF improvement.",2020,"After the intervention, children in the intervention group showed lower quick-temperedness and disruptiveness and improvement in hot EF.",['One hundred and sixteen children aged 8-9\xa0years'],['theory-based intervention in physical education (PE) designed to train self-control'],['lower quick-temperedness and disruptiveness and improvement in hot EF'],"[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444519', 'cui_str': 'Hot'}]",116.0,0.0483361,"After the intervention, children in the intervention group showed lower quick-temperedness and disruptiveness and improvement in hot EF.","[{'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pesce', 'Affiliation': 'University of Rome ""Foro Italico"".'}, {'ForeName': 'Kimberley D', 'Initials': 'KD', 'LastName': 'Lakes', 'Affiliation': 'University of California, Riverside.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Stodden', 'Affiliation': 'University of South Carolina.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Marchetti', 'Affiliation': 'Italian Ministry of Education.'}]",Child development,['10.1111/cdev.13445']
2177,32840872,Maintenance treatment with antipsychotic drugs for schizophrenia.,"BACKGROUND


The symptoms and signs of schizophrenia have been linked to high levels of dopamine in specific areas of the brain (limbic system). Antipsychotic drugs block the transmission of dopamine in the brain and reduce the acute symptoms of the disorder. An original version of the current review, published in 2012, examined whether antipsychotic drugs are also effective for relapse prevention. This is the updated version of the aforesaid review.
OBJECTIVES


To review the effects of maintaining antipsychotic drugs for people with schizophrenia compared to withdrawing these agents.
SEARCH METHODS


We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials including the registries of clinical trials (12 November 2008, 10 October 2017, 3 July 2018, 11 September 2019).
SELECTION CRITERIA


We included all randomised trials comparing maintenance treatment with antipsychotic drugs and placebo for people with schizophrenia or schizophrenia-like psychoses.
DATA COLLECTION AND ANALYSIS


We extracted data independently. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CIs) on an intention-to-treat basis based on a random-effects model. For continuous data, we calculated mean differences (MD) or standardised mean differences (SMD), again based on a random-effects model.
MAIN RESULTS


The review currently includes 75 randomised controlled trials (RCTs) involving 9145 participants comparing antipsychotic medication with placebo. The trials were published from 1959 to 2017 and their size ranged between 14 and 420 participants. In many studies the methods of randomisation, allocation and blinding were poorly reported. However, restricting the analysis to studies at low risk of bias gave similar results. Although this and other potential sources of bias limited the overall quality, the efficacy of antipsychotic drugs for maintenance treatment in schizophrenia was clear. Antipsychotic drugs were more effective than placebo in preventing relapse at seven to 12 months (primary outcome; drug 24% versus placebo 61%, 30 RCTs, n = 4249, RR 0.38, 95% CI 0.32 to 0.45, number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 3; high-certainty evidence). Hospitalisation was also reduced, however, the baseline risk was lower (drug 7% versus placebo 18%, 21 RCTs, n = 3558, RR 0.43, 95% CI 0.32 to 0.57, NNTB 8, 95% CI 6 to 14; high-certainty evidence). More participants in the placebo group than in the antipsychotic drug group left the studies early due to any reason (at seven to 12 months: drug 36% versus placebo 62%, 24 RCTs, n = 3951, RR 0.56, 95% CI 0.48 to 0.65, NNTB 4, 95% CI 3 to 5; high-certainty evidence) and due to inefficacy of treatment (at seven to 12 months: drug 18% versus placebo 46%, 24 RCTs, n = 3951, RR 0.37, 95% CI 0.31 to 0.44, NNTB 3, 95% CI 3 to 4). Quality of life might be better in drug-treated participants (7 RCTs, n = 1573 SMD -0.32, 95% CI to -0.57 to -0.07; low-certainty evidence); probably the same for social functioning (15 RCTs, n = 3588, SMD -0.43, 95% CI -0.53 to -0.34; moderate-certainty evidence). Underpowered data revealed no evidence of a difference between groups for the outcome 'Death due to suicide' (drug 0.04% versus placebo 0.1%, 19 RCTs, n = 4634, RR 0.60, 95% CI 0.12 to 2.97,low-certainty evidence) and for the number of participants in employment (at 9 to 15 months, drug 39% versus placebo 34%, 3 RCTs, n = 593, RR 1.08, 95% CI 0.82 to 1.41, low certainty evidence). Antipsychotic drugs (as a group and irrespective of duration) were associated with more participants experiencing movement disorders (e.g. at least one movement disorder: drug 14% versus placebo 8%, 29 RCTs, n = 5276, RR 1.52, 95% CI 1.25 to 1.85, number needed to treat for an additional harmful outcome (NNTH) 20, 95% CI 14 to 50), sedation (drug 8% versus placebo 5%, 18 RCTs, n = 4078, RR 1.52, 95% CI 1.24 to 1.86, NNTH 50, 95% CI not significant), and weight gain (drug 9% versus placebo 6%, 19 RCTs, n = 4767, RR 1.69, 95% CI 1.21 to 2.35, NNTH 25, 95% CI 20 to 50).
AUTHORS' CONCLUSIONS


For people with schizophrenia, the evidence suggests that maintenance on antipsychotic drugs prevents relapse to a much greater extent than placebo for approximately up to two years of follow-up. This effect must be weighed against the adverse effects of antipsychotic drugs. Future studies should better clarify the long-term morbidity and mortality associated with these drugs.",2020,"Underpowered data revealed no evidence of a difference between groups for the outcome 'Death due to suicide' (drug 0.04% versus placebo 0.1%, 19 RCTs, n = 4634, RR 0.60, 95% CI 0.12 to 2.97,low-certainty evidence) and for the number of participants in employment (at 9 to 15 months, drug 39% versus placebo 34%, 3 RCTs, n = 593, RR 1.08, 95% CI 0.82 to 1.41, low certainty evidence).","[""Cochrane Schizophrenia Group's Study-Based Register of Trials including the registries of clinical trials (12 November 2008, 10 October 2017, 3 July 2018, 11 September 2019"", 'people with schizophrenia or schizophrenia-like psychoses', 'schizophrenia', 'people with schizophrenia', '1959 to 2017 and their size ranged between 14 and 420 participants', '9145 participants comparing']","['antipsychotic medication with placebo', 'placebo', 'antipsychotic drugs and placebo']","['calculated risk ratios (RR', 'baseline risk', 'relapse', 'weight gain', 'social functioning', 'Hospitalisation', 'sedation', 'Quality of life']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",9145.0,0.684445,"Underpowered data revealed no evidence of a difference between groups for the outcome 'Death due to suicide' (drug 0.04% versus placebo 0.1%, 19 RCTs, n = 4634, RR 0.60, 95% CI 0.12 to 2.97,low-certainty evidence) and for the number of participants in employment (at 9 to 15 months, drug 39% versus placebo 34%, 3 RCTs, n = 593, RR 1.08, 95% CI 0.82 to 1.41, low certainty evidence).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ceraso', 'Affiliation': 'Department of Clinical and Experimental Sciences, Section of Psychiatry, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Jessie Jingxia', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong SAR, Hong Kong.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schneider-Thoma', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Siafis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Magdolna', 'Initials': 'M', 'LastName': 'Tardy', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München Klinikum rechts der Isar, München, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Komossa', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'Klinik Nord, München, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Kissling', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Maryland Psychiatric Research Center, Baltimore, MD, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Munich, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008016.pub3']
2178,32840891,Randomized controlled trial on the effectiveness of web-based Genomics Nursing Education Intervention for undergraduate nursing students: a study protocol.,"AIM


To describe a randomized controlled trial protocol that will evaluate the effectiveness of two web-based genomic nursing education interventions.
BACKGROUND


Preparing future nurses to be competent in genetic and genomic concepts is fundamental to ensure appropriate clinical application. However, genetics-genomics concepts are still new in the field of nursing. Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students. To address these knowledge gaps, a web-based 'Genomic Nursing Education Intervention' will be developed and compared with an existing online education programme.
DESIGN


A randomized controlled trial of two groups with pre-test and repeated posttesting.
METHODS


The Genomic Nursing Concept Inventory, a validated tool, will be used to assess the genetics-genomics knowledge of nursing students. Participants will be randomly allocated to either a control or an intervention group. The control group will receive the standard web-based nursing education, while the intervention group will receive a newly developed web-based education intervention. Outcome measures include the students' knowledge level of nursing genetics-genomics concepts. Participants will be retested at 3 and 6 months.
CONCLUSION


Current evidence shows that ensuring nurses have adequate education in genetic-genomic concepts is challenging. This study will demonstrate which of two web-based nursing education methods is more effective in teaching genetic-genomic concepts. This research project will better prepare the nursing profession in their careers for the emerging advance technologies in genetics-genomics and personalized health care.
IMPACT


Current evidence shows major challenges in ensuring that nurses have adequate education in genetics-genomics concepts. Less is known about what approaches to web-based education are effective to improve the knowledge gaps of nursing students in genetics-genomics concepts. This study will determine which type of web-based nursing education is effective in improving the genetics-genomics knowledge of nursing students. This research project will help better prepare nurses in dealing with advances in genetics-genomics in their careers.
TRIAL REGISTRATION


This study is registered in ClinicalTrials.gov (ID number NCT03963687) https://clinicaltrials.gov/show/NCT03963687.",2020,Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students.,"['nursing students', 'undergraduate nursing students']","['standard web-based nursing education, while the intervention group will receive a newly developed web-based education intervention', 'web-based Genomics Nursing Education Intervention']","[""students' knowledge level of nursing genetics-genomics concepts""]","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",,0.117689,Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students.,"[{'ForeName': 'Anndra Margareth', 'Initials': 'AM', 'LastName': 'Dumo', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Bobbi', 'Initials': 'B', 'LastName': 'Laing', 'Affiliation': 'School of Nursing, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anecita Gigi', 'Initials': 'AG', 'LastName': 'Lim', 'Affiliation': 'School of Nursing, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Erlinda', 'Initials': 'E', 'LastName': 'Palaganas', 'Affiliation': 'University of the Philippines, Baguio, Philippines.'}, {'ForeName': 'Peter James', 'Initials': 'PJ', 'LastName': 'Abad', 'Affiliation': 'College of Nursing, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Valdehueza', 'Affiliation': 'Don Mariano Marcos Memorial State University, La Union, Philippines.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Palovaara', 'Affiliation': 'Jyväskylä University of Applied Sciences, Jyväskylä, Finland.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Saunders', 'Affiliation': 'South-Eastern Finland University of Applied Sciences, Kouvola, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Estola', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Mandysova', 'Affiliation': 'Department of Nursing, Faculty of Health Studies, University of Pardubice, Pardubice, Czech Republic.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Maguire', 'Affiliation': 'Faculty of Health, University of Technology, Sydney, Australia.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Ward', 'Affiliation': 'Clemson University School of Nursing, Clemson, SC, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Carlberg', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Vehviläinen-Julkunen', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}]",Journal of advanced nursing,['10.1111/jan.14477']
2179,32840955,Video Cognitive-Behavioral Therapy for Insomnia in Cancer Patients : A Cost-Effective Alternative.,"OBJECTIVE


Despite its high prevalence, cancer-related insomnia typically remains untreated because of a lack of access to cognitive-behavioral therapy for insomnia (CBT-I), the treatment of choice for this condition. While face-to-face CBT-I appears to be optimal in terms of efficacy, self-administered formats may be more cost-effective. The goal of this secondary analysis of a randomized clinical trial was to compare the cost-effectiveness of a professionally-based CBT-I (PCBT-I) to that of a video-based CBT-I (VCBT-I).
METHODS


A total of 161 women with breast cancer received six weekly, individual CBT-I sessions (PCBT-I; n = 81) or a 60-min animated video + 6 short booklets (VCBT-I; n = 80). Participants completed the Insomnia Severity Index (ISI) and provided information to calculate treatment costs.
RESULTS


Total per patient treatment costs were 5.5 times greater for PCBT-I ($1298.90) than VCBT-I ($234.36; p<.0001). Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT-I than VCBT-I, but these differences were not significant (p=.09 and p=.24, respectively). In contrast, the cost-effectiveness ratio was significantly more advantageous for VCBT-I than PCBT-I. Compared to VCBT-I, each reduction of 1 unit on the ISI produced by PCBT-I was associated with a treatment cost that was significantly greater at posttreatment ($186.95 CAD vs. $44.87 CAD; p=.001) and follow-up ($154.76 vs. $24.97, p=.005).
CONCLUSIONS


Although CBT-I is slightly less efficacious when self-administered, it constitutes a much more cost-effective alternative than face-to-face CBT-I and represents an extremely valuable option in settings where monetary and human resources required to administer CBT-I are not available or sufficient. This article is protected by copyright. All rights reserved.",2020,"Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT","['161 women with breast cancer', 'Cancer Patients ']","['individual CBT-I sessions (PCBT-I; n =\u200981) or a 60-min animated video + 6 short booklets', 'professionally-based CBT-I (PCBT-I', 'PCBT', 'Video Cognitive-Behavioral Therapy', 'video-based CBT-I (VCBT-I']","['Insomnia Severity Index (ISI', 'cost-effectiveness', 'cost-effectiveness ratio', 'ISI reduction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",161.0,0.0324276,"Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT","[{'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'School of Psychology, Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ivers', 'Affiliation': 'School of Psychology, Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'School of Psychology, Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Economics, Université Laval, Québec, Québec, Canada.'}]",Psycho-oncology,['10.1002/pon.5532']
2180,32833475,Intervening on fear after acute cardiac events: Rationale and design of the INFORM randomized clinical trial.,"OBJECTIVE


Many acute coronary syndrome (ACS) patients are nonadherent to cardiovascular medications despite their known benefits for lowering risk of recurrent cardiovascular events. Research suggests that greater cardiac-related fear of recurrence (FoR) may be associated with higher nonadherence to cardiovascular medications and avoidance of physical activity. We aim to test the effect of an intervention that targets FoR as a potentially modifiable mechanism underlying nonadherence to recommended health behaviors among patients with suspected ACS.
METHOD


The INFORM trial (""INvestigating Fear Of Recurrence as a modifiable Mechanism of behavior change to improve medication adherence in acute coronary syndrome patients"") is a double-blind, parallel-group randomized clinical trial. It compares an 8-session, at-home, electronic tablet-delivered, cognitive bias modification training (CBMT) intervention with a sham control. Patients who experience high perceived threat at the time of presentation to the emergency department (ED) with a suspected ACS are enrolled and randomized within 6 weeks of their ED visit. The primary outcome, FoR, is measured by the adapted Concerns about Recurrent ACS Scale. The trial also tests the intervention's effect on a potential mechanism of health behavior change that is inversely correlated with fear: an expansive future time perspective. Additional outcomes include electronically measured adherence to a cardiovascular medication and self-reported physical activity.
CONCLUSIONS


This study takes a mechanistic approach to addressing the dangerous problem of poor health behaviors after ACS. The trial will test whether targeting FoR or future time perspective by CBMT is a promising approach to improving nonadherence after ACS. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The trial also tests the intervention's effect on a potential mechanism of health behavior change that is inversely correlated with fear: an expansive future time perspective.,"['Patients who experience high perceived threat at the time of presentation to the emergency department (ED) with a suspected ACS', 'acute coronary syndrome patients', 'Many acute coronary syndrome (ACS', 'patients with suspected ACS']",['cognitive bias modification training (CBMT) intervention'],"['FoR, is measured by the adapted Concerns about Recurrent ACS Scale', 'electronically measured adherence to a cardiovascular medication and self-reported physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0007220', 'cui_str': 'Cardiovascular agent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.158535,The trial also tests the intervention's effect on a potential mechanism of health behavior change that is inversely correlated with fear: an expansive future time perspective.,"[{'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Birk', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Cumella', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lopez-Veneros', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center.'}, {'ForeName': 'Ammie', 'Initials': 'A', 'LastName': 'Jurado', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Romero', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lazarov', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000853']
2181,32833476,An observational study and randomized trial of stress reactivity in cancer disparities.,"OBJECTIVES


Physiological stress responses have been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes. Many African Americans experience stressful life events and circumstances. These social factors may contribute to an increased risk of advanced stage disease at diagnosis and/or faster progression, but not all African American women exposed to adverse social factors develop advanced stage disease. Similarly, women who have a limited number of stressors can develop advanced stage breast cancer. Highly individualized stress reactivity may account for these inconsistent associations.
METHOD


This report describes the rationale, design, and methods for an exploratory study that uses the experimental medicine approach to: (a) characterize the nature and distribution of stress reactivity among African American breast cancer survivors based on socioeconomic, clinical, and social stressors; (b) examine the impact of stress reactivity on temporal discounting; and (c) determine the extent to which stress reactivity and temporal discounting are associated with adherence to recommendations for cancer control behaviors and treatment compliance as part of the Science of Behavior Change Network.
RESULTS


This study addresses several empirical gaps about the most effective ways to develop behavior change interventions for a medically underserved population that continues to experience disparities in cancer morbidity and mortality.
CONCLUSIONS


Results from this research will provide the empirical and conceptual basis for future intervention protocols that target mechanisms that are critical to disparities in African American breast cancer survivors. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"These social factors may contribute to an increased risk of advanced stage disease at diagnosis and/or faster progression, but not all African American women exposed to adverse social factors develop advanced stage disease.","['African American breast cancer survivors', 'women who have a limited number of stressors can develop advanced stage breast cancer', 'cancer disparities']",[],[],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",[],[],,0.021179,"These social factors may contribute to an increased risk of advanced stage disease at diagnosis and/or faster progression, but not all African American women exposed to adverse social factors develop advanced stage disease.","[{'ForeName': 'Chanita Hughes', 'Initials': 'CH', 'LastName': 'Halbert', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences and Hollings Cancer Center, Medical University of South Carolina.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Jefferson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences and Hollings Cancer Center, Medical University of South Carolina.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences and Hollings Cancer Center, Medical University of South Carolina.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Froeliger', 'Affiliation': 'Hollings Cancer Center and Department of Neuroscience, Medical University of South Carolina.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Thaxton', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000882']
2182,32833477,Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy.,"OBJECTIVE


Preventive interventions for postpartum depression (PPD) are critical for women at elevated risk of PPD. Mindfulness based cognitive therapy - perinatal depression (MBCT-PD) is a preventive intervention that has been shown to reduce risk for PPD in women with a prior history of depression. The objective of this clinical trial is to examine two potential mechanisms of action of MBCT-PD, emotion regulation and cognitive control, using behavioral and neuroimaging methods.
METHOD


This baseline protocol describes a randomized control trial (RCT) with two arms, MBCT-PD and treatment as usual (TAU). We plan on enrolling 74 females with a prior history of a major depressive episode, with 37 participants randomized to each arm. Participants in the MBCT-PD arm will receive MBCT-PD during pregnancy, and the TAU group will receive standard prenatal care. All participants will complete the Center for Epidemiological Studies Depression Scale - Revised (CESD-R), Emotion Regulation Questionnaire (ERQ), and classic Stroop task at multiple points from pregnancy through six months postpartum. Participants will also complete an fMRI scan at six weeks postpartum.
RESULTS


All primary outcomes are collected at six weeks postpartum. Primary behavioral outcomes include: depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance. In parallel, the primary neurobiological outcomes include whole-brain activation during fMRI tasks when participants 1) regulate emotional responding and 2) engage cognitive control.
CONCLUSIONS


This results of this innovative RCT will help identify potential behavioral and neurobiological mechanisms of action of preventive interventions for PPD for in-depth examination in larger scale RCTs. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Primary behavioral outcomes include: depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance.","['women with a prior history of depression', 'women at elevated risk of PPD', '74 females with a prior history of a major depressive episode, with 37 participants randomized to each arm']","['Mindfulness based cognitive therapy - perinatal depression (MBCT-PD', 'MBCT-PD and treatment as usual (TAU']","['whole-brain activation during fMRI tasks when participants 1) regulate emotional responding and 2) engage cognitive control', 'Epidemiological Studies Depression Scale - Revised (CESD-R), Emotion Regulation Questionnaire (ERQ), and classic Stroop task', 'depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",74.0,0.123274,"Primary behavioral outcomes include: depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance.","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Mackiewicz Seghete', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Graham', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Lapidus', 'Affiliation': 'OHSU-PSU School of Public Health, Oregon Health & Science University.'}, {'ForeName': 'Evelyn L A', 'Initials': 'ELA', 'LastName': 'Jackson', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Doyle', 'Affiliation': 'Department of Behavioral Neuroscience, Oregon Health & Science University.'}, {'ForeName': 'Alicia B', 'Initials': 'AB', 'LastName': 'Feryn', 'Affiliation': 'OHSU-PSU School of Public Health, Oregon Health & Science University.'}, {'ForeName': 'Lucille A', 'Initials': 'LA', 'LastName': 'Moore', 'Affiliation': 'Department of Neurology, Oregon Health & Science University.'}, {'ForeName': 'Sherryl H', 'Initials': 'SH', 'LastName': 'Goodman', 'Affiliation': 'Department of Psychology, Emory University.'}, {'ForeName': 'Sona', 'Initials': 'S', 'LastName': 'Dimidjian', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000870']
2183,32833478,"The positive affect, promoting Positive Engagement, and Adherence for Life (APPEAL) feasibility trial: Design and rationale.","OBJECTIVE


To describe development of the Positive Affect, Promoting Positive Engagement, and Adherence for Life (APPEAL) program.
METHOD


APPEAL is intended to increase HIV medication adherence through promotion of positive affect, and was developed through an iterative process involving 6 focus groups (N = 34) that elicited feedback on intervention content, followed by an individually administered prepilot of the entire intervention (N = 7).
RESULTS


Participants provided feedback on important potential moderator variables, including depression, on mode of intervention administration, and on anticipated barriers and benefits to participation. Insights gained were used to finalize study procedures in preparation for a feasibility trial. For the feasibility trial, a total of 80 participants who, in the past 6 months have had at least one plasma HIV RNA >200 copies/mL, will be randomized to receive APPEAL or standard of care (N = 40 per group). Intervention group participants will receive 3 monthly, individually administered sessions, and all participants will have their medication adherence monitored and complete structured interviews at baseline and at 3 and 6 months.
CONCLUSION


The APPEAL program is innovative in that it focuses on promoting self-regulation of positive emotions, an understudied approach to promoting chronic disease self-management behaviors such as HIV medication adherence. Findings from the feasibility trial will gauge suitability of the APPEAL intervention and evaluation methods for subsequent testing in a confirmatory trial and will examine changes in positive affect, the primary mechanism of change targeted in the intervention. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The APPEAL program is innovative in that it focuses on promoting self-regulation of positive emotions, an understudied approach to promoting chronic disease self-management behaviors such as HIV medication adherence.","['80 participants who, in the past 6 months have had at least one plasma HIV RNA >200 copies/mL']",[],['HIV medication adherence'],"[{'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",80.0,0.100332,"The APPEAL program is innovative in that it focuses on promoting self-regulation of positive emotions, an understudied approach to promoting chronic disease self-management behaviors such as HIV medication adherence.","[{'ForeName': 'Tracey E', 'Initials': 'TE', 'LastName': 'Wilson', 'Affiliation': 'Department of Community Health Sciences and Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Chanée', 'Initials': 'C', 'LastName': 'Massiah', 'Affiliation': 'Department of Epidemiology and Biostatistics, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Radigan', 'Affiliation': 'Department of Epidemiology and Biostatistics, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'DeHovitz', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Usha S', 'Initials': 'US', 'LastName': 'Govindarajulu', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Holman', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Melendez', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Jameela', 'Initials': 'J', 'LastName': 'Yusuff', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000880']
2184,32833479,Can mindfulness mechanistically target worry to improve sleep disturbances? Theory and study protocol for app-based anxiety program.,"OBJECTIVE


Anxiety is associated with sleep disturbance and insomnia. Mindfulness-based interventions, such as mindfulness-based stress reduction, have shown consistent anxiety reduction. Mindfulness training has been theorized to affect reinforcement learning, affecting habitual behaviors such as smoking and overeating, but a direct mechanistic link between the use of mindfulness training for anxiety reduction and improvement in sleep has not been studied. Moreover, the mechanisms by which mindfulness might affect worry and subsequent sleep disturbances have not been elucidated. This study protocol evaluates the impact an app-based mindfulness training program for anxiety might have on decreasing worry and improvement in sleep.
METHOD


A randomized controlled study will be conducted in approximately 80 adults with worry that interferes with their sleep. Participants will be randomly allocated (1:1) to two groups: treatment-as-usual (TAU) or TAU + App-Based Mindfulness Training (Unwinding Anxiety app). The primary outcomes will be the non-reactivity subscale of the Five Facet Mindfulness Questionnaire and Patient-Reported Outcomes Measurement Information System sleep quality measures (Baer et al., 2008; Yu et al., 2011). Secondary outcomes will include the Penn State Worry Questionnaire, Generalized Anxiety Disorder-7, and Multidimensional Assessment of Interoceptive Awareness Scale (Mehling et al., 2012; Meyer, Miller, Metzger, & Borkovec, 1990; Spitzer, Kroenke, Williams, & Löwe, 2006).
DISCUSSION


This study will be the first to test the mechanism of app-based mindfulness training on worry and sleep disturbance. Testing the mechanistic effects of mindfulness training using the science of behavior change framework will help move the field forward both in further elucidation of potential mechanisms of mindfulness (e.g., targeting reinforcement learning) and determining whether such a platform might be a viable method for delivering high-fidelity treatment at scale and for a low cost. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"This study protocol evaluates the impact an app-based mindfulness training program for anxiety might have on decreasing worry and improvement in sleep.
",['approximately 80 adults with worry that interferes with their sleep'],"['mindfulness training', 'app-based mindfulness training', 'treatment-as-usual (TAU) or TAU + App-Based Mindfulness Training (Unwinding Anxiety app', 'Mindfulness training', 'app-based mindfulness training program']","['non-reactivity subscale of the Five Facet Mindfulness Questionnaire and Patient-Reported Outcomes Measurement Information System sleep quality measures', 'worry and sleep disturbance', 'Penn State Worry Questionnaire, Generalized Anxiety Disorder-7, and Multidimensional Assessment of Interoceptive Awareness Scale (Mehling et al., 2012; Meyer, Miller, Metzger, & Borkovec, 1990; Spitzer, Kroenke, Williams, & Löwe, 2006']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0402830', 'cui_str': 'Miller'}]",,0.0200502,"This study protocol evaluates the impact an app-based mindfulness training program for anxiety might have on decreasing worry and improvement in sleep.
","[{'ForeName': 'Judson A', 'Initials': 'JA', 'LastName': 'Brewer', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Deluty', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hoge', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000874']
2185,32833481,"Episodic future thinking, delay discounting, and exercise during weight loss maintenance: The PACE trial.","OBJECTIVES


Weight loss maintenance (WLM) is the next major challenge in obesity treatment. While most individuals who lose weight intend to keep their weight off, weight regain is common. Temporal Self-Regulation Theory posits that whether intentions lead to behavior depends on self-regulatory capacity, including delay discounting (DD; the tendency to discount a larger future reward in favor of a smaller immediate reward). Episodic Future Thinking (EFT; mental imagery of a future event for which a health goal is important) may improve DD and promote behavior change. Described herein is a trial protocol designed to examine whether EFT improves DD within the context of weight loss maintenance.
METHOD


Participants who lose ≥5% of initial body weight in an online behavioral weight loss intervention will be randomly assigned to a standard weight loss maintenance program (WLM-STD) or a weight loss maintenance program plus EFT (WLM + EFT). Both interventions involve periodic phone and in-person treatment sessions. Participants in WLM + EFT will engage in daily EFT training via smartphone. To control for contact, participants in WLM-STD will engage in daily Healthy Thinking (reviewing strategies for weight management) on their smartphone. Our primary hypothesis is that WLM + EFT will yield better improvements in DD compared to WLM-STD. We will also explore whether DD mediates the relationship between intervention allocation and physical activity (secondary outcome). Weight and contextual variables will be explored.
CONCLUSIONS


This study is the first to test whether EFT improves DD within the context of weight loss maintenance; results from this experimental medicine approach could have important implications for understanding the impact of both EFT and DD on sustained behavior change. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Episodic Future Thinking (EFT; mental imagery of a future event for which a health goal is important) may improve DD and promote behavior change.,['Participants who lose ≥5% of initial body weight in an online behavioral weight loss intervention'],"['EFT', 'WLM + EFT', 'standard weight loss maintenance program (WLM-STD) or a weight loss maintenance program plus EFT (WLM + EFT']","['Episodic future thinking, delay discounting, and exercise during weight loss maintenance']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.0351094,Episodic Future Thinking (EFT; mental imagery of a future event for which a health goal is important) may improve DD and promote behavior change.,"[{'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, Department of Allied Health Sciences, University of Connecticut.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gorin', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, Department of Psychological Sciences, University of Connecticut.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wyckoff', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, Department of Psychological Sciences, University of Connecticut.'}, {'ForeName': 'Zeely', 'Initials': 'Z', 'LastName': 'Denmat', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Field', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut.'}, {'ForeName': 'Genevieve F', 'Initials': 'GF', 'LastName': 'Dunton', 'Affiliation': 'Department of Preventive Medicine, University of Southern California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gunstad', 'Affiliation': 'Department of Psychological Sciences, Kent State University.'}, {'ForeName': 'Tania B', 'Initials': 'TB', 'LastName': 'Huedo-Medina', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, and Department of Allied Health Sciences, University of Connecticut.'}, {'ForeName': 'Carnisha', 'Initials': 'C', 'LastName': 'Gilder', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, and Department of Allied Health Sciences, University of Connecticut.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000860']
2186,32833482,Behavioral strategies to reduce stress reactivity in opioid use disorder: Study design.,"OBJECTIVES


More than 2 million people in the United States had an opioid use disorder in 2017. Treatment for opioid use disorder-particularly medication combined with psychosocial support-is effective for reducing opioid use and decreasing overdose risk. However, approximately 50% of people who receive treatment will relapse or drop out. Stress reactivity, defined as the subjective and physiological response to stress, is heightened in people with opioid use disorder and higher stress reactivity is associated with poorer outcomes. Preliminary studies suggest that stress reactivity may be a key mechanistic target for improving outcomes. This article describes the design of an ongoing study examining behavioral strategies for reducing stress reactivity in adults with opioid use disorder. Our objective is to test the efficacy of two behavioral strategies for reducing stress reactivity and enhancing behavioral persistence in the context of stress (distress tolerance).
METHOD


We will recruit 120 adults with opioid use disorder and randomly assign them to brief training in (a) cognitive reappraisal, (b) affect labeling, or (c) a psychoeducational control. Participants will receive the training intervention followed by a laboratory stressor during which they will be instructed to apply the trained skill.
RESULTS


Subjective and physiological responses to stress will be measured as indices of stress reactivity and the stressor task will include a behavioral persistence component as a measure of distress tolerance.
CONCLUSIONS


The ultimate goal of this study is to inform the development of behavioral interventions that can be used as an adjunct to medication-based treatment for opioid use disorder. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Treatment for opioid use disorder-particularly medication combined with psychosocial support-is effective for reducing opioid use and decreasing overdose risk.,"['120 adults with opioid use disorder and randomly assign them to', 'adults with opioid use disorder', 'More than 2 million people in the United States had an opioid use disorder in 2017']","['training intervention followed by a laboratory stressor', 'brief training in (a) cognitive reappraisal, (b) affect labeling, or (c) a psychoeducational control']",['stress reactivity'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",120.0,0.0281808,Treatment for opioid use disorder-particularly medication combined with psychosocial support-is effective for reducing opioid use and decreasing overdose risk.,"[{'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital.'}, {'ForeName': 'Minh D', 'Initials': 'MD', 'LastName': 'Nguyen', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': 'Psychiatric Biostatistics Laboratory, McLean Hospital.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Dillon', 'Affiliation': 'Center for Depression Anxiety and Stress Research, McLean Hospital.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000862']
2187,32833483,A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults.,"Low income and low educational attainment are among the strongest predictors of both smoking prevalence and lapse (i.e., return) to smoking after cessation attempts. Treatment refinement is limited by inadequate knowledge of the specific lapse- or relapse-relevant vulnerabilities characteristic of populations that should be the target of treatment. In the context of a randomized clinical trial design, we describe an experimental medicine approach for evaluating the role of 2 specific lapse-relevant targets relative to the higher stress characteristic of low-socioeconomic contexts: low distress tolerance and low working memory capacity. Furthermore, we use an innovative approach for understanding risk of smoking lapse in smokers undergoing a quit attempt to examine candidate mechanistic targets assessed not only during nicotine use, but also during the conditions smokers will face upon a cessation attempt-during stressful nicotine-deprivation windows. This study is designed to show the incremental value of assessments during deprivation windows, in part because of the way in which specific vulnerabilities are modified by, and interact with, the heightened stress and withdrawal symptoms inherent to nicotine-deprivation states. Specifically, the study is designed to evaluate whether a novel mindfulness intervention (mindfulness combined with interoceptive exposure) can improve upon existing mindfulness interventions and extend therapeutic gains to the modification of mechanistic targets assessed in high-stress or negative affectivity contexts. The overall goal is to validate mechanistic targets and associated interventions for the purpose of expanding treatment options for at-risk smokers. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Low income and low educational attainment are among the strongest predictors of both smoking prevalence and lapse (i.e., return) to smoking after cessation attempts.",['low socioeconomic status (SES) adults'],"['novel mindfulness intervention (mindfulness combined with interoceptive exposure', 'working memory to aid smoking cessation']",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",[],,0.0214737,"Low income and low educational attainment are among the strongest predictors of both smoking prevalence and lapse (i.e., return) to smoking after cessation attempts.","[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Hoyt', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'McKee', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Addiction Recovery Research Center, Fralin Biomedical Research Institute.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, University of Texas at Austin.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000858']
2188,32833484,Moderated mediation for exercise maintenance in pain and posttraumatic stress disorder: A randomized trial.,"This study utilizes the Science of Behavior Change (SOBC) experimental medicine approach to evaluate the effects of a 3-month, individually prescribed progressive exercise training program on neurobiological, cognitive and motivational mechanisms by which our exercise-training paradigm may foster exercise maintenance. We will investigate hypothesized relationships between exercise-training associated augmentation of neuropeptide Y (NPY) system function and improvements in self-regulation and reward sensitivity-cognitive control and motivational processes posited to promote self-efficacy and intrinsic motivation, which have been shown to predict exercise maintenance. This study will recruit Veterans with chronic low back pain and posttraumatic stress disorder (PTSD). Procedures include a baseline, acute cardiopulmonary exercise challenge assessment that will inform the exercise prescription for a 12-week progressive exercise training program comprised of three 45-minute aerobic exercise sessions per week-all of which will be supervised by an exercise physiologist. Additionally, a week-7 and week-14 exercise challenge assessment will track changes in NPY system function and the variables of interest. We hypothesize that increases in the capacity to release NPY in response to acute exercise testing will be associated with improvements in self-regulation and reward sensitivity, which will in turn be associated with self-efficacy and intrinsic motivation to maintain regular exercise. Ninety participants will be randomized either to the ""active exercise training condition"" or to the ""wait list symptom monitoring condition"". The study aims to demonstrate the feasibility of procedures and elucidate mechanisms relevant to developing individually prescribed, motivationally based exercise regimens to reduce negative consequences of PTSD and low back pain over the long-term. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Ninety participants will be randomized either to the ""active exercise training condition"" or to the ""wait list symptom monitoring condition"".","['pain and posttraumatic stress disorder', 'Veterans with chronic low back pain and posttraumatic stress disorder (PTSD', 'Ninety participants']","['progressive exercise training program', 'progressive exercise training program comprised of three 45-minute aerobic exercise sessions per week-all of which will be supervised by an exercise physiologist', 'active exercise training condition"" or to the ""wait list symptom monitoring condition', 'exercise-training']",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",[],90.0,0.0229658,"Ninety participants will be randomized either to the ""active exercise training condition"" or to the ""wait list symptom monitoring condition"".","[{'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Scioli', 'Affiliation': ""Women's Health Sciences Division, National Center for PTSD, Research Service, VA Boston Healthcare System.""}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Smith', 'Affiliation': ""Women's Health Sciences Division, National Center for PTSD, Research Service, VA Boston Healthcare System.""}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Whitworth', 'Affiliation': 'National Center for PTSD, VA Boston Healthcare System.'}, {'ForeName': 'Avron', 'Initials': 'A', 'LastName': 'Spiro', 'Affiliation': 'Massachusetts Veterans Epidemiology and Research Information Center (MAVERIC) VA Boston Healthcare System.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Esterman', 'Affiliation': 'VA Boston Healthcare System.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Dutra', 'Affiliation': 'Clinical Psychology Department, William James College.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Bogdan', 'Affiliation': ""Women's Health Sciences Division, National Center for PTSD, Research Service, VA Boston Healthcare System.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Eld', 'Affiliation': ""Affiliate of Women's Health Sciences Division, National Center for PTSD, Research Service, VA Boston Healthcare System.""}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Rasmusson', 'Affiliation': ""Women's Health Sciences Division, National Center for PTSD, Research Service, VA Boston Healthcare System.""}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000876']
2189,32833539,Autologous Concentrated Growth Factors Combined with Topical Minoxidil for the Treatment of Male Androgenetic Alopecia: A Randomized Controlled Clinical Trial.,"Background:  Minoxidil (MXD) is an U.S. Food and Drug Administration-approved drug for the topical treatment of androgenetic alopecia (AGA) with minor side effects, but its hair growth (HG) effect is unsatisfactory.  Methods:  A double-blinded within-subjects randomized clinical trial was conducted on 16 male AGA patients who showed limited improvement after MXD treatment. Eligible participants received three concentrated growth factor (CGF) injections on half of the scalp and the placebo on the other side at 4-week intervals, and MXD was applied twice daily on both sides throughout the follow-up period. The primary endpoint was the HG ratio at V4. The secondary endpoints included the HG ratios at V2, V3, and V5; hair density and T/V ratio at V2, V3, V4, and V5; Global Aesthetic Improvement Scale (GAIS) scores at V4 and V5; and participant satisfaction at V4.  Results:  Each group included 16 subjects; each half of the scalp was randomly assigned to the MXD+CGF or MXD group. The HG ratio at V4 was higher in the MXD+CGF group than in the MXD group. The MXD+CGF group had significant improvements in hair density, HG ratio, and T/V ratio compared with the MXD group over the follow-up period. The GAIS scores and participant satisfaction were higher in the MXD+CGF group than in the MXD group. Unexpectedly, the MXD+CGF treatment hastened HG, which was sustained for 3 months after discontinuation. No severe adverse events occurred.  Conclusions:  The combined treatment of MXD and CGF is safe and more efficient for AGA patients. Combining CGF can expedite the potency of MXD and provide patients with fast and lasting HG.",2020,The GAIS scores and participant satisfaction were higher in the MXD+CGF group than in the MXD group.,"['Male Androgenetic Alopecia', '16 male AGA patients who showed limited improvement after MXD treatment', 'Each group included 16 subjects; each half of the scalp']","['MXD', 'MXD+CGF or MXD', 'Autologous Concentrated Growth Factors Combined with Topical Minoxidil', 'MXD+CGF', 'Minoxidil (MXD', 'concentrated growth factor (CGF) injections on half of the scalp and the placebo', 'MXD and CGF']","['HG ratio at V4', 'HG ratio', 'HG ratios at V2, V3, and V5; hair density and T/V ratio at V2, V3, V4, and V5; Global Aesthetic Improvement Scale (GAIS) scores at V4 and V5; and participant satisfaction at V4', 'GAIS scores and participant satisfaction', 'severe adverse events', 'hair density, HG ratio, and T/V ratio']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0730881', 'cui_str': 'Regaine'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0432284', 'cui_str': 'Infantile myofibromatosis'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0674679', 'cui_str': 'NBS1 protein, human'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",16.0,0.0695297,The GAIS scores and participant satisfaction were higher in the MXD+CGF group than in the MXD group.,"[{'ForeName': 'Poh-Ching', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}, {'ForeName': 'Pei-Qi', 'Initials': 'PQ', 'LastName': 'Zhang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Gao', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}, {'ForeName': 'Qing-Feng', 'Initials': 'QF', 'LastName': 'Li', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}, {'ForeName': 'Shuang-Bai', 'Initials': 'SB', 'LastName': 'Zhou', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.""}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2020.0288']
2190,32833549,Effect of Oral Nutritional Supplements on Patients with Esophageal Cancer During Radiotherapy.,"Background:  The purpose of this study was to investigate the effect of oral nutritional supplements (ONS) on patients with esophageal cancer during radiotherapy.  Materials and Methods:  Patients with esophageal cancer undergoing radiotherapy were randomly divided into nutritional intervention (NI) and routine treatment (RT) groups. All patients received one-on-one nutritional counseling and dietary advice, and patients in the NI group received ONS. Body mass index (BMI), a patient-generated subjective global assessment (PG-SGA), serum albumin (ALB), hemoglobin (Hb), white blood cell (WBC) count, prealbumin (PA), and platelets (PLTs) were recorded before and after radiotherapy in both the NI group and the RT group. Further, the adverse reactions during the treatment were evaluated.  Results:  In the NI group, the BMI after radiotherapy was significantly higher than that before radiotherapy, and the PG-SGA score after radiotherapy was significantly lower than that before radiotherapy ( p  < 0.05). In the RT group, the levels of BMI, Hb, ALB, PA, PLTs, and WBC after radiotherapy were significantly lower than those before radiotherapy, and the PG-SGA score was worse after radiotherapy ( p  < 0.05). After radiotherapy, the levels of BMI, Hb, ALB, and PA in the NI group were similar to those in the RT group ( p  > 0.05); whereas the levels of WBC and PLTs in the NI group were lower than those in the RT group ( p  < 0.05). During the treatment, the toxic reactions of radiation esophagitis, myelosuppression, nausea, and vomiting were decreased in the NI group compared with the RT group.  Conclusions:  ONS can reduce weight loss and improve the nutritional status of patients with esophageal cancer during radiotherapy.",2020,"In the RT group, the levels of BMI, Hb, ALB, PA, PLTs, and WBC after radiotherapy were significantly lower than those before radiotherapy, and the PG-SGA score was worse after radiotherapy ( p  < 0.05).","['Patients with esophageal cancer undergoing', 'Patients with Esophageal Cancer', 'patients with esophageal cancer during radiotherapy']","['ONS', 'nutritional intervention (NI) and routine treatment (RT', 'Oral Nutritional Supplements', 'oral nutritional supplements (ONS', 'radiotherapy']","['weight loss', 'PG-SGA score', 'levels of BMI, Hb, ALB, PA, PLTs, and WBC after radiotherapy', 'adverse reactions', 'levels of BMI, Hb, ALB, and PA', 'BMI after radiotherapy', 'Body mass index (BMI), a patient-generated subjective global assessment (PG-SGA), serum albumin (ALB), hemoglobin (Hb), white blood cell (WBC) count, prealbumin (PA), and platelets (PLTs', 'toxic reactions of radiation esophagitis, myelosuppression, nausea, and vomiting', 'levels of WBC and PLTs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0542243', 'cui_str': 'Toxic reaction (NOS)'}, {'cui': 'C0238113', 'cui_str': 'Radiation esophagitis'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0162247,"In the RT group, the levels of BMI, Hb, ALB, PA, PLTs, and WBC after radiotherapy were significantly lower than those before radiotherapy, and the PG-SGA score was worse after radiotherapy ( p  < 0.05).","[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Zhenchao', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Lingran', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Radiotherapy Oncology, The First Affiliated Hospital of University of Science and Technology of China (West Area), Anhui Provincial Cancer Hospital, Hefei, China.'}]",Cancer biotherapy & radiopharmaceuticals,['10.1089/cbr.2020.3888']
2191,32833578,Efficacy of Scaling and Root Planing with Photobiomodulation for Treating Periodontitis in Gutka Chewers: A Randomized Controlled Trial.,"Objective:  To explore the influence of photobiomodulation (PBMT) as an adjuvant to scaling and root planing (SRP) for treating periodontitis among  gutka  chewers.  Materials and methods:  Self-reported smokeless-tobacco ( gutka ) users were enrolled; and underwent SRP with (test group) and without (control group) PBMT. Full-mouth plaque index (P-I), bleeding upon probing (BUP), probing depth (P-D) clinical attachment loss (CAL), marginal bone loss (MBL) (on mesial and distal surfaces of the teeth), and number of missing teeth were recorded before treatment and at 3 and6 months. Group comparisons were performed and  p  < 0.05 was referred significant.  Results:  In the control group, P-I ( p  < 0.013), BUP ( p  < 0.001), and P-D ( p  < 0.012) were high at baseline compared with 3 months follow-up. P-I, BUP, and P-D were higher in the test group, at baseline in comparison with the 3-month ( p  < 0.001) and 6-month ( p  < 0.01) follow-up. At 3 and 6 months, scores of P-I, BUP, and P-D were high in the control compared with the test group. No difference in CAL, and mesial and distal MBL was found among patients of both groups at 3 and 6 months.  Conclusions:  Among  gutka  chewers, SRP with PBMT is more efficient than SRP alone in the management of periodontitis.",2020,"No difference in CAL, and mesial and distal MBL was found among patients of both groups at 3 and 6 months.  ","['Treating Periodontitis in Gutka Chewers', 'Self-reported smokeless-tobacco ( gutka ) users were enrolled; and underwent']","['Scaling and Root Planing with Photobiomodulation', 'photobiomodulation (PBMT', 'scaling and root planing (SRP', 'SRP', 'SRP with (test group) and without (control group) PBMT']","['BUP', 'Full-mouth plaque index (P-I), bleeding upon probing (BUP), probing depth (P-D) clinical attachment loss (CAL), marginal bone loss (MBL) (on mesial and distal surfaces of the teeth), and number of missing teeth', 'P-I, BUP, and P-D', 'CAL, and mesial and distal MBL', 'scores of P-I, BUP, and P-D']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4289021', 'cui_str': 'Gutka Tobacco'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.054574,"No difference in CAL, and mesial and distal MBL was found among patients of both groups at 3 and 6 months.  ","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Rabiah', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nawwaf', 'Initials': 'N', 'LastName': 'Al-Hamoudi', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Khulud Abdulrahman', 'Initials': 'KA', 'LastName': 'Al-Aali', 'Affiliation': 'Department of Clinical Dental Sciences, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Lonnie', 'Initials': 'L', 'LastName': 'Slapar', 'Affiliation': 'Department of General Dentistry, Eastman Institute for Oral Health, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'AlHelal', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Modhi', 'Initials': 'M', 'LastName': 'Al Deeb', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Mokeem', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4819']
2192,32833584,Thromboelastography to Assess Coagulopathy in Traumatic Brain Injury Patients Undergoing Therapeutic Hypothermia.,"Therapeutic hypothermia has been a treatment option for patients with severe traumatic brain injury (TBI) for many years. There has, however, been uncertainty whether hypothermia in this context also increased clinical bleeding risk, perhaps due to platelet dysfunction. Standard coagulation tests do not allow accurate assessment of  in vivo  coagulation. We studied specific coagulation abnormalities in patients undergoing therapeutic hypothermia for severe TBI using bedside thromboelastography (TEG).We studied 20 patients with severe blunt TBI from a single tertiary ICU who were enrolled in the prophylactic hypothermia to lessen traumatic brain injury (POLAR) trial. Ten patients had been randomized to hypothermia, and 10 were controls receiving normothermic standard care. TEG was undertaken during and after therapeutic hypothermia, and at the same time points in controls. Coagulation profiles were then compared between the hypothermic and control patients, and also between hypothermia and later normothermia in the study patients. Patients were primarily young (mean age 34 years) and male (85%). Measures of injury severity, including Glasgow coma score and injury severity scale, were not different between groups. Using TEG, the median alpha angle was reduced in hypothermic patients compared with controls (69.2° vs. 72.0°,  p  = 0.02), although both were within the normal range. LY30 was also reduced (0.0% vs. 0.5%,  p  < 0.01). Both differences persisted when hypothermic patients were compared with themselves during later normothermia. Therapeutic hypothermia during severe TBI causes a small decrease in the rate of clot formation. However, this decrease is within the normal range, and is unlikely to be clinically significant.",2020,"LY30 was also reduced (0.0% vs. 0.5%,  p  < 0.01).","['Ten patients had been randomized to hypothermia, and 10 were controls receiving normothermic standard care', 'Traumatic Brain Injury Patients', 'Patients were primarily young (mean age 34 years) and male (85', 'patients with severe traumatic brain injury (TBI) for many years', 'patients undergoing therapeutic hypothermia for severe TBI using bedside thromboelastography (TEG).We studied 20 patients with severe blunt TBI from a single tertiary ICU who were enrolled in the prophylactic hypothermia to lessen traumatic brain injury (POLAR) trial']","['Therapeutic hypothermia', 'Thromboelastography', 'TEG']","['injury severity, including Glasgow coma score and injury severity scale', 'Coagulation profiles', 'rate of clot formation', 'median alpha angle']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005790', 'cui_str': 'Blood coagulation panel'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",20.0,0.0295413,"LY30 was also reduced (0.0% vs. 0.5%,  p  < 0.01).","[{'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Quine', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lynnette', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Trapani', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Cooper', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2020.0025']
2193,32833606,Correction to: Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,,2020,,['After Aneurysmal Subarachnoid Hemorrhage'],['Goal-Directed Therapy'],['Delayed Ischemia'],"[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C0022116', 'cui_str': 'Ischemia'}]",,0.271616,,[],Stroke,['10.1161/STR.0000000000000348']
2194,32833762,Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial).,"OBJECTIVE


To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial.
BACKGROUND


While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival.
METHODS


Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695.
RESULTS


Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
CONCLUSIONS


This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.",2020,"Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
","['Between March 2008 and November 2015', '115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial', '144 patients', 'Malignant Left-sided Colonic Obstruction', 'Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive']","['SBTS or ES', 'SBTS', 'stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES']","['obstruction', 'DFS', 'OS', 'TTP', 'overall (OS), time to progression (TTP), and disease-free survival (DFS', 'OS, TTP, and DFS']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0235328', 'cui_str': 'Obstruction of colon'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0460048', 'cui_str': 'Large bowel obstruction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",59.0,0.384575,"Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Arezzo', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Forcignanò', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Marco Augusto', 'Initials': 'MA', 'LastName': 'Bonino', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Balagué', 'Affiliation': 'Surgical Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Targarona', 'Affiliation': 'Surgical Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Borghi', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giraudo', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ghezzo', 'Affiliation': 'ASO Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Passera', 'Affiliation': 'Department of Medical sciences, University of Torino, Torino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Morino', 'Affiliation': 'Department of Surgical Sciences, University of Torino, Torino, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004324']
2195,32833763,"3D Versus 4K Display System - Influence of ""State-of-the-art""-Display Technique on Surgical Performance (IDOSP-study) in Minimally Invasive Surgery: A Randomized Cross-over Trial.","OBJECTIVE


To evaluate if ""state-of-the-art"" 3D- versus 4K-display techniques could influence surgical performance.
BACKGROUND


High quality minimally invasive surgery is challenging. Therefore excellent vision is crucial. 3D display technique (3D) and 2D-4K technique (4K) are designed to facilitate surgical performance, either due to spatial resolution (3D) or due to very high resolution (4K).
METHODS


In randomized cross-over trial the surgical performance of medical students (MS), non-board certified surgeons (NBC), and board certified surgeons (BC) was compared using 3D versus 4K display technique at a minimally invasive training Parkour.
RESULTS


One hundred twenty-eight participants were included (February 2018 through October 2019, 49 MS, 39 NBC, 40 BC). The overall Parkour time (s) 3D versus 4K was 712.5 s ± 17.5 s versus 999.5 s ± 25.1 s (P < 0.001) for all levels of experience. It was (3D vs 4K) for MS (30 tasks) 555.4 s ± 28.9 s versus 858.7 s ± 41.6 s, (P < 0.0001), for NBC (42 tasks) 935.9 s ± 31.5 s versus 1274.1 s ± 45.1 s (P =< 0.001) and for BC (42 task) 646.3 s ± 30.9 s versus 865.7 s ± 43.7 s (P < 0.001). The overall number of mistakes was (3D vs 4K) 10.0 ± 0.5 versus 13.3 ± 0.7 (P < 0.001), for MS 8.9 ± 0.9 versus 13.1 ± 1.1 (P < 0.001), for NBC 12.45 ± 1.0 versus 16.7 ± 1.2 (P < 0.001) and for BC 8.8 ± 1.0 versus 10.0 ± 1.2 (P = 0.18). MS, BC, and NBC showed shorter performance time in 100% of the task with 3D (significantly in 6/7 tasks). For number of mistakes the effect was less pronounced for more experienced surgeons. The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


3D laparoscopic display technique optimizes surgical performance compared to the 4K technique. Surgeons benefit from the improved visualization regardless of their individual surgical expertise.",2020,"The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


","['One hundred twenty-eight participants were included (February 2018 through October 2019, 49 MS, 39 NBC, 40 BC', 'medical students (MS), non-board certified surgeons (NBC), and board certified surgeons (BC', 'Minimally Invasive Surgery']",['3D display technique (3D) and 2D-4K technique (4K'],"['overall number of mistakes', 'MS, BC, and NBC showed shorter performance time', 'overall Parkour time (s']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",128.0,0.079681,"The National Aeronautics and Space Administration-task load index was lower with 3D.
CONCLUSION


","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Wahba', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Rabi', 'Initials': 'R', 'LastName': 'Datta', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Bußhoff', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hedergott', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gietzelt', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Dieplinger', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Fuchs', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Gynecology and Gynecologic Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Desdemona', 'Initials': 'D', 'LastName': 'Möller', 'Affiliation': 'Faculty of Management, Economics and Social Sciences, Department of Business Administration and Health Care Management, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Dirk L', 'Initials': 'DL', 'LastName': 'Stippel', 'Affiliation': 'Department of General, Visceral, Cancer and Transplant Surgery, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000004328']
2196,32833767,Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer.,"OBJECTIVE


To investigate if prolonged TTS after completed nCRT improves postoperative outcomes for esophageal and esophagogastric junction cancer.
SUMMARY OF BACKGROUND DATA


TTS has traditionally been 4-6 weeks after completed nCRT. However, the optimal timing is not known.
METHODS


A multicenter clinical trial was performed with randomized allocation of TTS of 4-6 or 10-12 weeks. The primary endpoint of this sub-study was overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay. The study was registered in Clinicaltrials.gov (NCT02415101).
RESULTS


In total 249 patients were randomized. There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603). There were no statistically significant differences between standard and prolonged TTS regarding anastomotic leak (P = 0.596), conduit necrosis (P = 0.524), chyle leak (P = 0.427), pneumonia (P = 0.548), and respiratory failure (P = 0.723). In the standard TTS arm 5 patients (4.3%) died within 90 days of surgery, compared to 4 patients (3.8%) in the prolonged TTS arm (P = 1.0). Median length of hospital stay was 15 days in the standard TTS arm and 17 days in the prolonged TTS arm (P = 0.234).
CONCLUSION


The timing of surgery after completed nCRT for carcinoma of the esophagus or esophagogastric junction, is not of major importance with regard to short-term postoperative outcomes.",2020,"There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603).","['Esophageal Cancer', 'esophageal and esophagogastric junction cancer', 'In total 249 patients']","['Prolonged Time to Surgery', 'nCRT', 'Neoadjuvant Chemoradiotherapy', 'TTS']","['standard and prolonged TTS regarding anastomotic leak', 'pneumonia', 'conduit necrosis', 'Surgical Morbidity and Mortality', 'Median length of hospital stay', 'overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay', 'Clavien-Dindo grade IIIb-V complications', 'respiratory failure', 'chyle leak', 'overall incidence of complications Clavien-Dindo grade II-V']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0008730', 'cui_str': 'Chyle'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",249.0,0.272683,"There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603).","[{'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Nilsson', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Klevebro', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Rouvelas', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lindblad', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Halldestam', 'Affiliation': 'Department of Surgery, University Hospital of Linköping, Linköping, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Smedh', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Gothenburg Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Wallner', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Johansson', 'Affiliation': 'Department of Surgery, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gjermund', 'Initials': 'G', 'LastName': 'Johnsen', 'Affiliation': ""Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Eirik Kjus', 'Initials': 'EK', 'LastName': 'Aahlin', 'Affiliation': 'Department of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Hans-Olaf', 'Initials': 'HO', 'LastName': 'Johannessen', 'Affiliation': 'Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Geir Olav', 'Initials': 'GO', 'LastName': 'Hjortland', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bartella', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schröder', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.'}]",Annals of surgery,['10.1097/SLA.0000000000004340']
2197,32833791,Prism adaptation treatment for upper-limb Complex Regional Pain Syndrome: a double-blind randomized controlled trial.,"Initial evidence suggested that people with Complex Regional Pain Syndrome (CRPS) have reduced attention to the affected side of their body and the surrounding space, which might be related to pain and other clinical symptoms. Three previous unblinded, uncontrolled studies showed pain relief following treatment with prism adaptation, an intervention that has been used to counter lateralised attention bias in brain-lesioned patients. To provide a robust test of its effectiveness for CRPS, we conducted a double-blind randomized controlled trial of prism adaptation for unilateral upper-limb CRPS-I. Forty-nine eligible adults with CRPS were randomized to undergo two-weeks of twice-daily home-based prism adaptation treatment (n = 23) or sham treatment (n = 26). Outcomes were assessed in person four weeks prior to and immediately before treatment, and immediately after and four weeks post-treatment. Long-term postal follow-ups were conducted three and six months after treatment. We examined the effects of prism adaptation versus sham treatment on current pain intensity and CRPS symptom severity score (primary outcomes); as well as sensory, motor, and autonomic functions, self-reported psychological functioning, and experimentally tested neuropsychological functions (secondary outcomes). We found no evidence that primary or secondary outcomes differed between the prism adaptation and sham treatment groups when tested at either time point following treatment. Overall, CRPS severity significantly decreased over time for both groups, but we found no benefits of prism adaptation beyond sham treatment. Our findings do not support the efficacy of prism adaptation treatment for relieving upper-limb CRPS-I. This trial was prospectively registered (ISRCTN46828292).",2020,"Overall, CRPS severity significantly decreased over time for both groups, but we found no benefits of prism adaptation beyond sham treatment.","['upper-limb Complex Regional Pain Syndrome', 'unilateral upper-limb CRPS-I. Forty-nine eligible adults with CRPS', 'people with Complex Regional Pain Syndrome (CRPS']","['prism adaptation versus sham treatment', 'prism adaptation', 'Prism adaptation treatment', 'prism adaptation treatment', 'twice-daily home-based prism adaptation treatment']","['sensory, motor, and autonomic functions, self-reported psychological functioning, and experimentally tested neuropsychological functions', 'Overall, CRPS severity', 'current pain intensity and CRPS symptom severity score', 'pain relief']","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",49.0,0.411187,"Overall, CRPS severity significantly decreased over time for both groups, but we found no benefits of prism adaptation beyond sham treatment.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Halicka', 'Affiliation': 'Centre for Pain Research, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Vittersø', 'Affiliation': 'Centre for Pain Research, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'McCullough', 'Affiliation': 'Pain Research Institute, Department of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goebel', 'Affiliation': 'Pain Research Institute, Department of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Heelas', 'Affiliation': 'Optimise Pain Rehabilitation Unit, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Proulx', 'Affiliation': 'Department of Psychology, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Bultitude', 'Affiliation': 'Centre for Pain Research, University of Bath, Bath, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000002053']
2198,32833851,Ultrasound-guided interscalene block combined with intermediate or superficial cervical plexus block for clavicle surgery: A randomised clinical study.,"BACKGROUND


The complex innervation of the clavicle makes general anaesthesia a preferred technique for clavicular surgeries in current practice. The role and approach of regional anaesthesia remains unanswered.
OBJECTIVES


This study aims to delineate the relative effectiveness between interscalene brachial plexus block with either intermediate cervical plexus or superficial cervical plexus block (CPB) as the anaesthetics for clavicular surgery.
DESIGN


A randomised, double-blind prospective study.
SETTING


Single-centre, tertiary care medical college and research institute.
PATIENTS


Fifty patients with American Society of Anesthesiologist's (ASA) grade I to III, aged 18 to 70 years, scheduled for clavicular surgery, during May 2018 to April 2019 were enrolled in this study.
INTERVENTION


All patients received interscalene block with 10 ml of 0.5% bupivacaine. Patients were randomised to undergo additional ultrasound-guided intermediate CPB (Group-1) or superficial CPB (Group-2) with 10 ml of 0.5% bupivacaine.
MAIN OUTCOME MEASURES


The block success rate, sensory block onset time, haemodynamic parameters, duration of postoperative analgesia and complications were noted. Categorical data were analysed using the chi-square test and Fisher's exact test. Continuous data were analysed using Student's t-test.
RESULT


In Group 1, block success was 100%. In Group 2, five patients failed to achieve adequate surgical anaesthesia (P = 0.02). The average sensory block onset time in Group 1 was 2.5 ± 0.4 min and was longer in Group 2, 4.3 ± 0.5 min (P < 0.001). There was no difference between the groups with respect to haemodynamic parameters and complications. The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
CONCLUSION


Ultrasound-guided combined interscalene and intermediate CPB had a better success rate, with faster sensory block onset time and prolonged postoperative analgesia as compared with interscalene and superficial CPB in patients undergoing clavicle surgery.
TRIAL REGISTRATION


Clinical trial registry of India (www.ctri.nic.in) - CTRI/2018/05/013785.",2020,"The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
","['clavicle surgery', 'Single-centre, tertiary care medical college and research institute', ""Fifty patients with American Society of Anesthesiologist's (ASA) grade I to III, aged 18 to 70 years, scheduled for clavicular surgery, during May 2018 to April 2019 were enrolled in this study"", 'patients undergoing clavicle surgery']","['interscalene block with 10\u200aml of 0.5% bupivacaine', 'Ultrasound-guided interscalene block combined with intermediate or superficial cervical plexus block', 'interscalene brachial plexus block with either intermediate cervical plexus or superficial cervical plexus block (CPB', 'interscalene and superficial CPB', 'additional ultrasound-guided intermediate CPB (Group-1) or superficial CPB (Group-2) with 10\u200aml of 0.5% bupivacaine', 'Ultrasound-guided combined interscalene and intermediate CPB']","['mean duration of postoperative analgesia', 'block success rate, sensory block onset time, haemodynamic parameters, duration of postoperative analgesia and complications', 'average sensory block onset time', 'adequate surgical anaesthesia', 'haemodynamic parameters and complications', 'block success']","[{'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block'}, {'cui': 'C0007854', 'cui_str': 'Cervical plexus structure'}, {'cui': 'C0394689', 'cui_str': 'Injection of anesthetic agent into cervical plexus'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",50.0,0.119153,"The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
","[{'ForeName': 'B Krishna', 'Initials': 'BK', 'LastName': 'Arjun', 'Affiliation': 'Department of Anaesthesiology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Chinnamaregowda N', 'Initials': 'CN', 'LastName': 'Vinod', 'Affiliation': ''}, {'ForeName': 'Jayanna', 'Initials': 'J', 'LastName': 'Puneeth', 'Affiliation': ''}, {'ForeName': 'Madappa C', 'Initials': 'MC', 'LastName': 'Narendrababu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001300']
2199,32833858,Perioperative ADministration of Dexamethasone And blood Glucose concentrations in patients undergoing elective non-cardiac surgery - the randomised controlled PADDAG trial.,"BACKGROUND


The hyperglycaemic effect of dexamethasone in diabetic and nondiabetic patients in the peri-operative period is unknown.
OBJECTIVE


To assess the effect of a single dose of intra-operative dexamethasone on peri-operative blood glucose.
DESIGN


Multicentre, stratified, randomised trial.
SETTING


University hospitals in Australia and Hong Kong.
PATIENTS


A total of 302 adults scheduled for elective, noncardiac and nonobstetric surgical procedures under general anaesthesia, stratified by diabetes mellitus status, were randomised to receive placebo, 4 or 8 mg dexamethasone administered intravenously after induction of anaesthesia.
MAIN OUTCOME MEASURES


Maximum blood glucose within 24 h of surgery, and the interaction between glycated haemoglobin (HbA1c) and dexamethasone were the primary and secondary outcomes.
RESULTS


The median [IQR] baseline blood glucose in the nondiabetes stratum in the placebo (n=81), 4 mg (n=81) and 8 mg dexamethasone (n=77) trial arms were respectively 5.3 [4.6 to 5.8], 5.0 [4.7 to 5.4] and 5.0 [4.2 to 5.9] mmol l. In the diabetes stratum these values were 6.6 [6.0 to 8.3]; (n=22), 6.1 [5.5 to 10.4]; (n=22) and 6.7 [5.6 to 8.3]; (n=19) mmol l. The median [IQR] maximum peri-operative blood glucose values in the nondiabetes stratum were 6.0 [5.3 to 6.8], 6.3 [5.5 to 7.3] and 6.3 [5.8 to 7.4] mmol l in the control, dexamethasone 4 mg and dexamethasone 8 mg arms, respectively. In the diabetes stratum these values were 10.3 [8.1 to 12.4], 12.6 [10.3 to 18.3] and 13.6 [11.2 to 0.1] mmol l. There was a significant interaction between pre-operative HbA1c value and 8 mg dexamethasone: every 1% increment in HbA1c produced a 4.0 mmol l elevation in maximal peri-operative glucose concentration.
CONCLUSION


Dexamethasone four or 8 mg did not induce greater hyperglycaemia compared with placebo for nondiabetic and well controlled diabetic patients. Maximal peri-operative blood glucose concentrations in patients with diabetes were related to baseline HbA1c values in a concentration-dependent fashion after 8 mg of dexamethasone.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Registry (ACTRN12614001145695): URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367272.",2020,Dexamethasone four or 8 mg did not induce greater hyperglycaemia compared with placebo for nondiabetic and well controlled diabetic patients.,"['302 adults scheduled for elective, noncardiac and nonobstetric surgical procedures under general anaesthesia, stratified by diabetes mellitus status', 'University hospitals in Australia and Hong Kong', 'diabetic and nondiabetic patients', 'patients with diabetes', 'nondiabetic and well controlled diabetic patients', 'patients undergoing elective non-cardiac surgery ']","['Dexamethasone And blood Glucose concentrations', 'intra-operative dexamethasone', 'URL', 'dexamethasone', 'Dexamethasone', 'placebo']","['Maximum blood glucose', 'glycated haemoglobin (HbA1c) and dexamethasone', 'median [IQR] baseline blood glucose', 'median [IQR] maximum peri-operative blood glucose values', 'Maximal peri-operative blood glucose concentrations', 'hyperglycaemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",302.0,0.304096,Dexamethasone four or 8 mg did not induce greater hyperglycaemia compared with placebo for nondiabetic and well controlled diabetic patients.,"[{'ForeName': 'Tomás B', 'Initials': 'TB', 'LastName': 'Corcoran', 'Affiliation': 'From the Department of Anaesthesia and Pain Medicine, Royal Perth Hospital (TBC), School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia (TBC, EOL), Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria (TBC), Department of Anaesthesia and Pain Medicine, Fiona Stanley Hospital, Perth, Western Australia, Australia (EOL), Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China (MAC), Department of Intensive Care Medicine, Royal Perth Hospital (KMH), Medical School, University of Western Australia (KMH) and School of Veterinary & Life Sciences, Murdoch University, Perth, Western Australia, Australia (KMH).'}, {'ForeName': 'Edmond', 'Initials': 'E', 'LastName': ""O'Loughlin"", 'Affiliation': ''}, {'ForeName': 'Matthew T V', 'Initials': 'MTV', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Kwok M', 'Initials': 'KM', 'LastName': 'Ho', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001294']
2200,32833889,Comparison of Cross-Education and Global Training Effects in Adults and Youth After Unilateral Strength Training.,"Chaouachi, A, Ben Othman, A, Chaouachi, M, Hechmi, A, Farthing, JP, Granacher, U, and Behm, DG. Comparison of cross-education and global training effects in adults and youth after unilateral strength training. J Strength Cond Res XX(X): 000-000, 2020-Youth strength training research examining contralateral, homologous (cross-education), and heterologous (global training) effects after unilateral training have provided mixed results and the relationship to adults has not been compared. The objective was to compare adult and youth cross-education and global training effects on dominant and nondominant limb testing. Initially, 15 men and 15 prepubertal boys volunteered for each unilateral chest press (CP), handgrip training, and control groups (n = 89). Individuals trained their dominant limb 3 times per week for 8 weeks and had their dominant and nondominant limbs tested for CP and leg press 1 repetition maximum (1RM), handgrip, knee extension and flexion, and elbow extension and flexion maximum voluntary isometric contractions (MVICs). Adult CP training gains were significantly greater than youth with lower-body testing (p = 0.002-0.06), whereas youth CP training gains exceeded adults with upper-body tests (p = 0.03-0.07). Training specificity was evident with greater CP 1RM increases with CP vs. handgrip training for both youth (p < 0.0001) and adults (p < 0.0001). Handgrip training elicited greater gains in handgrip MVICs compared with other strength tests (p < 0.0001). In conclusion, only contralateral CP 1RM showed a training advantage for unilateral CP over unilateral handgrip training. Adults showed greater gains with lower-body testing, whereas youth showed greater gains with upper-body testing.",2020,"Adult CP training gains were significantly greater than youth with lower-body testing (p = 0.002-0.06), whereas youth CP training gains exceeded adults with upper-body tests (p = 0.03-0.07).","['adults and youth after unilateral strength training', 'Adults and Youth', '15 men and 15 prepubertal boys volunteered for each']","['unilateral handgrip training', '2020-Youth strength training research examining contralateral, homologous (cross-education), and heterologous (global training', 'J Strength Cond Res XX(X', 'unilateral chest press (CP), handgrip training', 'Handgrip training']","['gains in handgrip MVICs', 'CP and leg press 1 repetition maximum (1RM), handgrip, knee extension and flexion, and elbow extension and flexion maximum voluntary isometric contractions (MVICs', 'Adult CP training gains', 'CP 1RM', 'youth CP training gains']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",89.0,0.014647,"Adult CP training gains were significantly greater than youth with lower-body testing (p = 0.002-0.06), whereas youth CP training gains exceeded adults with upper-body tests (p = 0.03-0.07).","[{'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Chaouachi', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimisation,"" National Center of Medicine and Science in Sports (CNMSS), Tunis, Tunisia.'}, {'ForeName': 'Aymen', 'Initials': 'A', 'LastName': 'Ben Othman', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimisation,"" National Center of Medicine and Science in Sports (CNMSS), Tunis, Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Chaouachi', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimisation,"" National Center of Medicine and Science in Sports (CNMSS), Tunis, Tunisia.'}, {'ForeName': 'Abderraouf', 'Initials': 'A', 'LastName': 'Hechmi', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimisation,"" National Center of Medicine and Science in Sports (CNMSS), Tunis, Tunisia.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Farthing', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Science, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003766']
2201,32833890,Reduced Dose of Beta-Alanine Is Sufficient to Maintain Performance in Repeated Sprints.,"Zandona, BA, Ramos, RA, de Oliveira, CdS, McAnulty, SR, Ferreira, LHB, Smolarek, AC, Enes, AAN, Urbinati, KMdSS, Aragon, AA, Schoenfeld, BJ, and de Souza Junior, TP. Reduced Dose of Beta-Alanine Is Sufficient to Maintain Performance in Repeated Sprints. J Strength Cond Res XX(X): 000-000, 2020-Beta-alanine (BA) supplementation has been shown to be effective in improving physical performance by increasing carnosine concentration. However, it is still necessary to know the effect of a maintenance dose on performance. Thus, this study aimed to investigate the effects of a maintenance dose of BA supplementation on performance. Forty-four anaerobically trained men with 23.9 ± 3.8 years of age, 176.0 ± 0.05 cm height, 81.2 ± 7.5 kg body mass, and 15.5 ± 2.9% of body fat performed a cycle ergometer test consisting of 4 sprints of 30 s with 4 minutes of active recovery. The study comprised 3 phases: (a) presupplementation, (b) supplementation with 6.4 g·d BA or placebo, and (c) postsupplementation with a maintenance dose of 1.2 g·d of BA or interruption of supplementation. Data were analyzed using generalized estimated equations with a priori 0.05 level of significance. The placebo group and interruption group presented a lower power (7.28 ± 0.66 and 7.71 ± 0.42 W·kg vs. 8.04 ± 0.84 and 9.25 ± 1.18 W·kg, respectively; p < 0.05) during the third sprint in postsupplementation, whereas the maintenance group maintained the required power (7.47 ± 1.03 vs. 8.74 ± 1.07 W·kg; p > 0.05). The placebo group also presented higher percentage of fatigue (44.5% ± 12.3 and 44.8% ± 7.7 vs. 37.6 ± 7.2%; p = 0.021) and higher subjective perception of exertion (8.92 ± 0.90 vs. 8.00 ± 1.60; p = 0.028). Therefore, the maintenance dose of 1.2 g·d BA was effective in maintaining performance, whereas a reduction in performance was observed after supplementation interruption.",2020,The placebo group also presented higher percentage of fatigue (44.5% ± 12.3 and 44.8% ± 7.7 vs. 37.6 ± 7.2%; p = 0.021) and higher subjective perception of exertion (8.92 ± 0.90 vs. 8.00 ± 1.60; p = 0.028).,"['Forty-four anaerobically trained men with 23.9 ± 3.8 years of age, 176.0 ± 0.05 cm height, 81.2 ± 7.5 kg body mass, and 15.5 ± 2.9% of body fat performed a cycle ergometer test consisting of 4 sprints of 30 s with 4 minutes of active recovery']","['2020-Beta-alanine (BA) supplementation', 'BA supplementation', 'presupplementation, (b) supplementation with 6.4 g·d BA or placebo, and (c) postsupplementation with a maintenance dose of 1.2 g·d of BA or interruption of supplementation', 'J Strength Cond Res XX(X', 'placebo']","['Zandona, BA, Ramos, RA, de Oliveira, CdS, McAnulty, SR, Ferreira, LHB, Smolarek, AC, Enes, AAN, Urbinati, KMdSS, Aragon, AA, Schoenfeld, BJ', 'higher subjective perception of exertion', 'percentage of fatigue']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",44.0,0.236183,The placebo group also presented higher percentage of fatigue (44.5% ± 12.3 and 44.8% ± 7.7 vs. 37.6 ± 7.2%; p = 0.021) and higher subjective perception of exertion (8.92 ± 0.90 vs. 8.00 ± 1.60; p = 0.028).,"[{'ForeName': 'Bruna A', 'Initials': 'BA', 'LastName': 'Zandona', 'Affiliation': 'Research Group on Metabolism, Nutrition and Strength Training, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Renan A', 'Initials': 'RA', 'LastName': 'Ramos', 'Affiliation': 'Research Group on Metabolism, Nutrition and Strength Training, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Cleyton Dos Santos', 'Initials': 'CDS', 'LastName': 'de Oliveira', 'Affiliation': 'Research Group on Metabolism, Nutrition and Strength Training, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'McAnulty', 'Affiliation': 'Department of Health and Exercise Science, Appalachian State University, Boone, North Carolina.'}, {'ForeName': 'Luis H B', 'Initials': 'LHB', 'LastName': 'Ferreira', 'Affiliation': 'Research Group on Metabolism, Nutrition and Strength Training, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Smolarek', 'Affiliation': 'Research Group on Metabolism, Nutrition and Strength Training, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Alysson A N', 'Initials': 'AAN', 'LastName': 'Enes', 'Affiliation': 'Research Group on Metabolism, Nutrition and Strength Training, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Keith Mary de Souza Sato', 'Initials': 'KMSS', 'LastName': 'Urbinati', 'Affiliation': 'Graduate Program in Health Technology, Pontifical Catholic University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Aragon', 'Affiliation': 'California State University, Northridge, California.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronkx, New York.'}, {'ForeName': 'Tácito P', 'Initials': 'TP', 'LastName': 'de Souza Junior', 'Affiliation': 'Research Group on Metabolism, Nutrition and Strength Training, Federal University of Paraná, Curitiba, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003715']
2202,32833919,Placental lipid metabolism in preeclampsia.,"OBJECTIVES


The current study examines the placental and maternal lipid profile and expression of genes involved in placental lipid metabolism in women with preeclampsia.
METHODS


The current study includes normotensive control women (n = 40) and women with preeclampsia (n = 39). Preeclampsia women were further classified into women delivering at term preeclampsia (T-PE; n = 15) and preterm preeclampsia (PT-PE; n = 24).
RESULTS


There were no significant differences in maternal lipid profile between the T-PE and normotensive control groups. Maternal plasma VLDL (P < 0.05) and ratios of total cholesterol : HDL (P < 0.05), atherogenic index [log (triglycerides/HDL)] (P < 0.01) and apolipoprotein B : apolipoprotein A (P < 0.05) were higher in the PT-PE group as compared with the normotensive control group. Placental total cholesterol and HDL levels were higher (P < 0.05) in the T-PE as compared with the normotensive control group. Higher placental triglycerides (P < 0.05) were observed in PT-PE group compared with T-PE group. Placental mRNA levels of peroxisome proliferator activated receptor α, carnitine palmitoyl transferase-1, cluster of differentiation 36 and lipoprotein lipases were lower (P < 0.05) in the PT-PE than normotensive control group. A negative association of mRNA levels of peroxisome proliferator activated receptor α (r = -0.246, P = 0.032; r = -0.308, P = 0.007, respectively), carnitine palmitoyl transferase-1 (r = -0.292, P = 0.011; r = -0.366, P = 0.001), lipoprotein lipases (r = -0.296, P = 0.010; r = -0.254, P = 0.028) with SBP and DBP was observed. There was a positive association of placental triglycerides (r = 0.244, P = 0.031) with DBP.
CONCLUSION


Women with preeclampsia exhibit higher lipid : lipoprotein ratios suggesting an atherogenic state particularly in women delivering preterm. Lower expression of genes involved in placental fatty acid oxidation and transport was also observed in preeclampsia.",2020,Higher placental triglycerides (P < 0.05) were observed in PT-PE group compared with T-PE group.,"['Women with preeclampsia exhibit higher lipid\u200a', 'women with preeclampsia', 'normotensive control women (n\u200a=\u200a40) and women with preeclampsia (n\u200a=\u200a39', 'Preeclampsia women were further classified into women delivering at term preeclampsia (T-PE; n\u200a=\u200a15) and preterm preeclampsia (PT-PE; n\u200a=\u200a24', 'preeclampsia']",[],"['placental fatty acid oxidation and transport', 'Higher placental triglycerides', 'SBP and DBP', 'placental triglycerides', 'atherogenic index [log (triglycerides/HDL', 'Placental lipid metabolism', 'placental lipid metabolism', 'Placental mRNA levels of peroxisome proliferator activated receptor α, carnitine palmitoyl transferase-1, cluster of differentiation 36 and lipoprotein lipases', 'ratios of total cholesterol\u200a:\u200aHDL', 'maternal lipid profile', 'Maternal plasma VLDL', 'Placental total cholesterol and HDL levels', 'lipoprotein lipases', 'carnitine palmitoyl transferase-1 ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0851043', 'cui_str': 'Increased lipid'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",[],"[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0023816', 'cui_str': 'Lipoprotein lipase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}]",,0.0384321,Higher placental triglycerides (P < 0.05) were observed in PT-PE group compared with T-PE group.,"[{'ForeName': 'Amrita A', 'Initials': 'AA', 'LastName': 'Khaire', 'Affiliation': 'Mother and Child Health, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University).'}, {'ForeName': 'Shivani R', 'Initials': 'SR', 'LastName': 'Thakar', 'Affiliation': 'Mother and Child Health, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University).'}, {'ForeName': 'Girija N', 'Initials': 'GN', 'LastName': 'Wagh', 'Affiliation': 'Department of Obstetrics and Gynecology, Bharati Medical College and Hospital, Bharati Vidyapeeth University, Pune, India.'}, {'ForeName': 'Sadhana R', 'Initials': 'SR', 'LastName': 'Joshi', 'Affiliation': 'Mother and Child Health, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University).'}]",Journal of hypertension,['10.1097/HJH.0000000000002596']
2203,32833935,Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.,"BACKGROUND


African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.
OBJECTIVE


The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.
RESEARCH DESIGN


Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.
MEASURES


The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.
RESULTS


Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
CONCLUSION


A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.",2020,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","['African Americans and non-African Americans with diabetes', 'African Americans than non-African Americans', 'Slow Diabetic Kidney Disease', 'Primary care patients (N=281, 56% African American', 'African Americans']","['multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control', 'Multifactorial Telehealth Intervention', 'multifactorial telehealth intervention']","['preservation of eGFR', 'kidney function', 'estimated glomerular filtration rate (eGFR']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.068358,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Clarissa J', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Clemontina A', 'Initials': 'CA', 'LastName': 'Davenport', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Oakes', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Pendergast', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Uptal D', 'Initials': 'UD', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}]",Medical care,['10.1097/MLR.0000000000001387']
2204,32834469,The effect of episodic future simulation and motivation on young children's induced-state episodic foresight.,"Future simulation and motivation are two strategies that might help children improve their induced-state episodic foresight. In Study 1, 3- to 5-year-old children ( N  = 96) consumed pretzels (to induce thirst) and were asked what they would prefer the next day, pretzels or water. Children were randomly assigned to an experimental condition: (1) a standard thirsty condition, (2) an episodic simulation condition where they imagined being hungry the next day, (3) a motivation condition where children chose between a cupcake and water, or (4) a control condition (thirst was not induced). Future preferences did not differ by age and children were less likely to choose water (vs. a cupcake) in the motivation condition compared to the standard thirsty condition. Study 2 found that 3- to 5-year-old children ( N  = 22) were also less likely to choose water for  right now  versus a cupcake when thirst was induced.",2020,Future preferences did not differ by age and children were less likely to choose water (vs. a cupcake) in the motivation condition compared to the standard thirsty condition.,"[""young children's induced-state episodic foresight""]","['standard thirsty condition, (2) an episodic simulation condition where they imagined being hungry the next day, (3) a motivation condition where children chose between a cupcake and water, or (4) a control condition (thirst was not induced']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",[],96.0,0.0281451,Future preferences did not differ by age and children were less likely to choose water (vs. a cupcake) in the motivation condition compared to the standard thirsty condition.,"[{'ForeName': 'Caitlin E V', 'Initials': 'CEV', 'LastName': 'Mahy', 'Affiliation': 'Department of Psychology, Brock University, Canada.'}, {'ForeName': 'Chelsey', 'Initials': 'C', 'LastName': 'Masson', 'Affiliation': 'Department of Psychology, Brock University, Canada.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Krause', 'Affiliation': 'Faculty of Education, University of Ottawa, Canada.'}, {'ForeName': 'Tessa R', 'Initials': 'TR', 'LastName': 'Mazachowsky', 'Affiliation': 'Department of Psychology, Brock University, Canada.'}]",Cognitive development,['10.1016/j.cogdev.2020.100934']
2205,32835417,Predictors of Fracture in Older Women with Osteopenic Hip Bone Mineral Density Treated with Zoledronate.,"A recent analysis has found that, during treatment with denosumab, women attaining higher bone densities (BMD) are less likely to have incident fractures. We have re-examined this important question using data from our recent trial of zoledronate in osteopenic women. 1000 women randomized to treatment with zoledronate were followed for 6 years. 122 sustained fragility fractures during follow-up. Baseline age, non-vertebral fracture history, total hip BMD and calculated fracture risk were all significantly different between those who had fractures during the study and those who did not. BMDs achieved during the study were higher in those without incident fractures. However, achieved BMDs were very closely related to baseline values (r = 0.93, P < 0.0001). The increase in BMD during zoledronate treatment was not different between those who had incident fractures and those who did not (0.15 < P < 0.78), and change in BMD was not predictive of fracture (univariate logistic regression analysis). Stepwise regression analysis of all baseline variables showed the best independent predictors of fracture to be age (OR 1.08 [95% confidence interval 1.04,1.13], P = 0.0003), baseline spine BMD (OR 0.81 [0.67, 0.96], P = 0.016), and history of non-vertebral fracture (OR 1.69 [1.06,2.69], P = 0.028). Addition of change in BMD to this model did not improve its predictive power. If changes in BMD were included in the stepwise regression analysis of baseline variables, they did not emerge as significant predictors of fracture. It is concluded that age, fracture history and baseline BMD determine the risk of new fractures. Differences in achieved BMD between those who do or do not fracture arise from the close relationship between baseline and achieved BMDs. These findings suggest that targeting any particular BMD during treatment is unlikely to be a useful or valid strategy. This article is protected by copyright. All rights reserved.",2020,"The increase in BMD during zoledronate treatment was not different between those who had incident fractures and those who did not (0.15 < P < 0.78), and change in BMD was not predictive of fracture (univariate logistic regression analysis).","['1000 women randomized to treatment with', 'osteopenic women', 'Older Women with Osteopenic Hip Bone Mineral Density Treated with Zoledronate']",['zoledronate'],"['vertebral fracture history, total hip BMD and calculated fracture risk', 'achieved BMDs', 'history of non-vertebral fracture', 'baseline spine BMD', 'BMDs', 'BMD', '122 sustained fragility fractures']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate'}]","[{'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}]",1000.0,0.135112,"The increase in BMD during zoledronate treatment was not different between those who had incident fractures and those who did not (0.15 < P < 0.78), and change in BMD was not predictive of fracture (univariate logistic regression analysis).","[{'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Mihov', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Bolland', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Bastin', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4167']
2206,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
2207,32818600,Differential Activation and Functional Plasticity of Multimodal Areas Associated with Acquired Musical Skill.,"Training of a musical skill is known to produce a distributed neural representation of the ability to perceive music and perform musical tasks. In the present study we tested the hypothesis that the audiovisual perception of music involves a wider activation of multimodal sensory and sensorimotor structures in the brain, including those containing mirror neurons. We mapped the activation of brain areas during passive listening and viewing of the first 40 s of ""Ode to Joy"" being played on the piano by an expert pianist. To do this we performed brain functional magnetic resonance imaging during the presentation of 6 different stimulus contrasts pertaining to that musical melody in a pseudo-randomized order. Group data analysis in musically trained and untrained adults showed robust activation in broadly distributed occipitotemporal, parietal and frontal areas in trained subjects and much restricted activation in untrained subjects. A visual stimulus contrast focusing on the visual motion percept of moving fingers on piano keys revealed selective bilateral activation of a locus corresponding to the V5/MT area, which was significantly more pronounced in trained subjects and showed partial linear dependence on the duration of training on the left side. Quantitative analysis of individual brain volumes confirmed a significantly greater and wider spread of activation in trained compared to untrained subjects. These findings support the view that audiovisual perception of music and musical gestures in trained musicians involves an expanded and widely distributed neural representation formed due to experience-dependent plasticity.",2020,Quantitative analysis of individual brain volumes confirmed a significantly greater and wider spread of activation in trained compared to untrained subjects.,['musically trained and untrained adults'],[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0215397,Quantitative analysis of individual brain volumes confirmed a significantly greater and wider spread of activation in trained compared to untrained subjects.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yekovich', 'Affiliation': 'Shepherd School of Music, Rice University, Houston, TX, United States.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Rosenfield', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States; Shepherd School of Music, Rice University, Houston, TX, United States.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Helekar', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States. Electronic address: sahelekar@houstonmethodist.org.'}]",Neuroscience,['10.1016/j.neuroscience.2020.08.013']
2208,32819304,"The impact of high-intensity interval training exercise on breast cancer survivors: a pilot study to explore fitness, cardiac regulation and biomarkers of the stress systems.","BACKGROUND


Cardiovascular disease (CVD) remains the largest cause of death in breast cancer survivors. The aim of this study was to explore the impact of exercise intensity on aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, α-amylase) and mucosal immunity (secretory(s)-IgA), markers of increased risk of CVD in breast cancer survivors.
METHODS


Participants were randomly assigned to; 1) high intensity interval training (HIIT); 2) moderate-intensity, continuous aerobic training (CMIT); or 3) a wait-list control (CON) for a 12-week (36 session) stationary cycling intervention. Cardiorespiratory fitness (VO 2peak ), resting HRV and salivary biomarkers were measured at baseline 2-4 d pre-intervention and 2-4 d post the last exercise session.
RESULTS


Seventeen participants were included in this study (62 ± 8 years, HIIT; n = 6, CMIT; n = 5, CON; n = 6). A significant improvement (p ≤ 0.05) was observed for VO 2peak  in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group. Post intervention improvements in HRV markers of vagal activity (log (ln)LF/HF, LnRMSSD) and sympathetic nervous system (α-amylase waking response) occurred for individuals exhibiting outlying (> 95% CI) levels at baseline compared to general population.
CONCLUSION


High intensity interval training improved cardiovascular fitness in breast cancer survivors and improved cardiac regulation, and sympathetic nervous system (stress) responses in some individuals. High-intensity interval training was safe and effective for breast cancer survivors to participate in with promising results as a time efficient intensity to improve physical health and stress, reducing CVD risk.
TRIAL REGISTRATION


This pilot study was retrospectively registered through the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000684921 .",2020,"A significant improvement (p ≤ 0.05) was observed for VO 2peak  in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group.","['Seventeen participants were included in this study (62\u2009±\u20098\u2009years, HIIT; n\u2009=\u20096, CMIT; n\u2009=\u20095, CON; n\u2009=\u20096', 'Participants were randomly assigned to; 1', 'breast cancer survivors', 'Australian New Zealand Clinical Trials Registry (ANZCTR']","['high intensity interval training (HIIT); 2) moderate-intensity, continuous aerobic training (CMIT); or 3) a wait-list control (CON', 'high-intensity interval training exercise', 'High-intensity interval training', 'High intensity interval training']","['VO 2peak', 'cardiovascular fitness', 'cardiac regulation, and sympathetic nervous system (stress) responses', 'Cardiorespiratory fitness (VO 2peak ), resting HRV and salivary biomarkers', 'physical health and stress, reducing CVD risk', 'aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, α-amylase) and mucosal immunity (secretory(s)-IgA), markers of increased risk of CVD', 'HRV markers of vagal activity (log (ln)LF/HF, LnRMSSD) and sympathetic nervous system (α-amylase waking response']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0895355,"A significant improvement (p ≤ 0.05) was observed for VO 2peak  in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group.","[{'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Toohey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia. kellie.toohey@canberra.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pumpa', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKune', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Welvaert', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Northey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Quinlan', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}]",BMC cancer,['10.1186/s12885-020-07295-1']
2209,32819305,Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab.,"BACKGROUND


BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to comparatively assess efficacy and safety of BCD-022 and reference trastuzumab in combination with paclitaxel used as the therapy of metastatic HER2(+) breast cancer. Pharmacokinetics and immunogenicity were also studied.
METHODS


Patients with no previous treatment for metastatic HER2(+) breast cancer were randomly assigned 1:1 to BCD-022 or reference trastuzumab and were treated with trastuzumab + paclitaxel. Therapy continued for 6 cycles of therapy (every 3 weeks), until progression of the disease or unbearable toxicity. Primary study endpoint was overall response rate. Study goal was to prove equivalent efficacy of BCD-022 and reference trastuzumab. Equivalence margins for 95% CI for difference in overall response rates were set at [- 20%; 20%].
RESULTS


In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm. Overall response rate was 49.6% in BCD-022 arm and 43.6% in reference trastuzumab arm. Limits of 95% CI for difference of overall response rates between arms were [(- 8.05)-19.89%], thus, they lied within predetermined equivalence margins [- 20%; 20%]. Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding antibody occurrence rate (either BAb or NAb) was found between BCD-022 (n = 3; 2.65%) and comparator (n = 4; 3.64%). Both drug products are characterized with low occurrence rate and short life of anti-trastuzumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures: AUC 0-504 , С mах , Т max , T 1/2 . Analysis of C trough  did not reveal any significant inter-group differences as well.
CONCLUSIONS


Thus, results of this study have demonstrated therapeutic equivalence of trastuzumab biosimilar BCD-022 and referent trastuzumab drug.
TRIAL REGISTRATION


The trial was registered with ClinicalTrials.gov (Study Number NCT01764022 ). The date of registration was January 9, 2013.",2020,Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm).,"['Patients with no previous treatment for metastatic HER2(+) breast cancer', 'metastatic HER2(+) breast cancer', 'In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm']","['BCD-022 and reference trastuzumab', 'paclitaxel', 'biosimilar BCD-022 with reference trastuzumab', 'trastuzumab + paclitaxel', 'BCD-022 or reference trastuzumab']","['equivalent PK parameters', 'overall response rates', 'overall response rate', 'adverse events', 'adverse reactions', 'antibody occurrence rate (either BAb or NAb', 'Pharmacokinetics and immunogenicity', 'Overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0303401', 'cui_str': 'Indium-110'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",225.0,0.296749,Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm).,"[{'ForeName': 'Sergey M', 'Initials': 'SM', 'LastName': 'Alexeev', 'Affiliation': 'N.N. Petrov NII of Oncology of the Ministry of Healthcare of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Khorinko', 'Affiliation': 'SBHI of PK Perm Krai, Perm Krai Cancer Dispensary, Perm, Russian Federation.'}, {'ForeName': 'Guzel Z', 'Initials': 'GZ', 'LastName': 'Mukhametshina', 'Affiliation': 'SAHI Republican Clinical Cancer Dispensary of the Ministry of Healthcare of the Republic of Tatarstan, Kazan, Russian Federation.'}, {'ForeName': 'Konstantin G', 'Initials': 'KG', 'LastName': 'Shelepen', 'Affiliation': 'Brest Regional Clinical Cancer Dispensary, Volgograd, Russian Federation.'}, {'ForeName': 'Olga N', 'Initials': 'ON', 'LastName': 'Burdaeva', 'Affiliation': 'SBHI of Arkhangelsk Region Arkhangelsk Regional Clinical Cancer Dispensary, Arkhangelsk, Russian Federation.'}, {'ForeName': 'Sergey A', 'Initials': 'SA', 'LastName': 'Kulik', 'Affiliation': 'KLPU City Cancer Dispensary of the City of Donetsk, Donetsk, DNR, Ukraine.'}, {'ForeName': 'Chiradoni Thugappa', 'Initials': 'CT', 'LastName': 'Satheesh', 'Affiliation': 'Sri Venkateshwara Hospital, Bangalore, India.'}, {'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Srivastava', 'Affiliation': 'King Georges Medical University, Lucknow, India.'}, {'ForeName': 'Mummaneni', 'Initials': 'M', 'LastName': 'Vikranth', 'Affiliation': 'City Cancer Center, Vijayawada, India.'}, {'ForeName': 'Fedor', 'Initials': 'F', 'LastName': 'Kryukov', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation. kryukov@biocad.ru.'}, {'ForeName': 'Anastasia N', 'Initials': 'AN', 'LastName': 'Paltusova', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Mariya S', 'Initials': 'MS', 'LastName': 'Shustova', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Roman A', 'Initials': 'RA', 'LastName': 'Ivanov', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}]",BMC cancer,['10.1186/s12885-020-07247-9']
2210,32819312,Effectiveness of community-based folate-oriented tertiary interventions on incidence of fetus and birth defects: a protocol for a single-blind cluster randomized controlled trial.,"BACKGROUND


Birth defects are the main cause of fetal death, infant mortality and morbidity worldwide. However, the etiology of birth defects remains largely unknown. Maternal folate status during periconception plays an important role in organogenesis and folic acid supplement reduces the risk of neural tube defects, congenital heart diseases, and several other birth defects. This trial seeks to evaluate the effectiveness of folate-oriented tertiary interventions during periconception on the incidence of fetus and birth defects.
METHODS


This is a single-blind, two-arm cluster randomized controlled trial in Shanghai, China. Eligible women from 22 clusters are recruited at pre-pregnancy physical examinations clinical settings. Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm. The core interventions consist of assessments of folate status and metabolism, folate intake guidance, and re-evaluation of folate status to ensure red blood cell folate level above 400 ng/ml (906 nmol/L) before pregnancy. Screening and consulting of fetus and birth defects, and treatments of birth defects during pregnancy and afterward will be provided to both arms. The primary outcome is a composite incidence of fetus defects, stillbirth, and neonatal birth defects identified from the confirmation of pregnancy to 28 days after birth. Secondary outcomes include maternal and offspring adverse complications and cost-effectiveness of folate-oriented tertiary interventions. This protocol adheres to the SPIRIT Checklist.
DISCUSSION


To achieve the recommended folate status before or during pregnancy is still a challenge worldwide. This community-based cluster-randomized controlled intervention trial will evaluate the effectiveness of a package of interventions aiming at achieving recommended maternal folate status covering pre- and during pregnancy in reducing fetus and birth defects. Our study has the potential to improve the community-based practice of reducing modifiable risk factors of disease and improving primary prevention of the defects in China. The procedures would formulate the policy on folic acid supplementation during periconception against birth defects in primary care settings.
TRIAL REGISTRATION


Clinical Trial Registry, NCT03725878 . Prospectively registered on 31 October 2018.",2020,"Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm.","['Eligible women from 22 clusters are recruited at pre-pregnancy physical examinations clinical settings', 'Prospectively registered on 31 October 2018']","['routine perinatal care group (control arm), folate-oriented tertiary interventions', 'folate-oriented tertiary interventions', 'community-based folate-oriented tertiary interventions', 'folic acid supplementation']","['composite incidence of fetus defects, stillbirth, and neonatal birth defects identified from the confirmation of pregnancy to 28\u2009days after birth', 'incidence of fetus and birth defects', 'maternal and offspring adverse complications and cost-effectiveness of folate-oriented tertiary interventions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0242963', 'cui_str': 'Perinatal Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0549169', 'cui_str': 'Confirmation of pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.104388,"Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm.","[{'ForeName': 'Mengru', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Dingmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Yalan', 'Initials': 'Y', 'LastName': 'Dou', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China. yanwl@fudan.edu.cn.""}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China. gyhuang@shmu.edu.cn.""}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03154-w']
2211,32819390,Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study.,"BACKGROUND


Accurate detection of patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC) remains an urgent unmet clinical need to improve selection of patients who might benefit form adjuvant chemotherapy (ACT). Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease. The MEDOCC-CrEATE trial investigates how many stage II CC patients with detectable ctDNA after surgery will accept ACT and whether ACT reduces the risk of recurrence in these patients.
METHODS/DESIGN


MEDOCC-CrEATE follows the 'trial within cohorts' (TwiCs) design. Patients with colorectal cancer (CRC) are included in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) and give informed consent for collection of clinical data, tissue and blood samples, and consent for future randomization. MEDOCC-CrEATE is a subcohort within PLCRC consisting of 1320 stage II CC patients without indication for ACT according to current guidelines, who are randomized 1:1 into an experimental and a control arm. In the experimental arm, post-surgery blood samples and tissue are analyzed for tissue-informed detection of plasma ctDNA, using the PGDx elio™ platform. Patients with detectable ctDNA will be offered ACT consisting of 8 cycles of capecitabine plus oxaliplatin while patients without detectable ctDNA and patients in the control group will standard follow-up according to guideline. The primary endpoint is the proportion of patients receiving ACT when ctDNA is detectable after resection. The main secondary outcome is 2-year recurrence rate (RR), but also includes 5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness. Data will be analyzed by intention to treat.
DISCUSSION


The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group.
TRIAL REGISTRATION


Netherlands Trial Register: NL6281/NTR6455 . Registered 18 May 2017, https://www.trialregister.nl/trial/6281.",2020,Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease.,"['Patients with colorectal cancer (CRC', 'patients who might benefit form adjuvant chemotherapy (ACT', 'patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC', '1320 stage II CC patients without indication for ACT according to current guidelines', 'stage II colon cancer (MEDOCC-CrEATE']","['NL6281/NTR6455 ', 'ACT', 'capecitabine plus oxaliplatin']","['5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness', 'proportion of patients receiving ACT', '2-year recurrence rate (RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",,0.206776,Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Schraa', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'van Rooijen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'D E W', 'Initials': 'DEW', 'LastName': 'van der Kruijssen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rubio Alarcón', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Phallen', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sausen', 'Affiliation': 'Personal Genome Diagnostics, Baltimore, MD, 21224, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Simmons', 'Affiliation': 'Personal Genome Diagnostics, Baltimore, MD, 21224, USA.'}, {'ForeName': 'V M H', 'Initials': 'VMH', 'LastName': 'Coupé', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'W M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Elias', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Laclé', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'L J W', 'Initials': 'LJW', 'LastName': 'Bosch', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van den Broek', 'Affiliation': 'Department of Laboratory Medicine, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Meijer', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'V E', 'Initials': 'VE', 'LastName': 'Velculescu', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'R J A', 'Initials': 'RJA', 'LastName': 'Fijneman', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Vink', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. m.koopman-6@umcutrecht.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-07252-y']
2212,32819393,The effects of varying doses of caffeine on cardiac parasympathetic reactivation following an acute bout of anaerobic exercise in recreational athletes.,"BACKGROUND


To examine the effects of varying doses of caffeine on autonomic reactivation following anaerobic exercise.
METHODS


Recreationally active males (N = 20; 24 ± 2y) participated in a randomized, double-blind, placebo-controlled, crossover study where participants ingested: [1] Control (CON; no supplement), [2] a non-caffeinated placebo (PLA), [3] 3-mg∙kg - 1  of caffeine (CAF3) or [4] 6-mg∙kg - 1  of caffeine (CAF6) prior to Wingate testing. Parasympathetic (lnRMSSD, primary outcome) and global HRV (lnSDNN, secondary outcome) were assessed at rest (i.e., pre-ingestion), 45-min post-ingestion, and 5-min and 35-min post-exercise recovery. We used a GLM to assess mean (95% CI) changes from pre-ingestion baseline.
RESULTS


Overall, we observed a significant trend for lnRMSSD and lnSDNN (both, p = 0.001, ηp 2  = 0.745). Forty-five minutes after treatment ingestion, we observed a significant increase in lnRMSSD for CAF3 (0.15 ms, 95%CI, 0.07,0.24) and CAF6 (0.16 ms, 95%CI, 0.06,0.25), both being significant (both, p <  0.004) vs. CON (- 0.02 ms, 95%CI, - 0.09,0.04). Five-minutes after exercise, all treatments demonstrated significant declines in lnRMSSD vs. baseline (all, p <  0.001). After 35-min of recovery, lnRMSSD returned to a level not significantly different than baseline for CAF3 (0.03 ms, 95%CI, - 0.05, 0.12) and CAF6 (- 0.03 ms, 95%CI, - 0.17, 0.10), while PLA (- 0.16 ms, 95%CI, - 0.25, - 0.06) and CON (- 0.17 ms, 95%CI, - 0.28, - 0.07) treatments remained significantly depressed. A similar pattern was also observed for SDNN.
CONCLUSION


Caffeine ingestion increases resting cardiac autonomic modulation and accelerates post-exercise autonomic recovery after a bout of anaerobic exercise in recreationally active young men. However, no differences between caffeine doses on cardiac autonomic reactivity were observed.",2020,"Five-minutes after exercise, all treatments demonstrated significant declines in lnRMSSD vs. baseline (all, p <  0.001).","['recreationally active young men', 'active males (N\u2009=\u200920; 24\u2009±\u20092y) participated', 'Recreationally', 'recreational athletes']","['caffeine (CAF6', 'caffeine', 'anaerobic exercise', 'ingested: [1] Control (CON; no supplement), [2] a non-caffeinated placebo (PLA), [3] 3-mg∙kg -\u20091  of caffeine (CAF3) or [4', 'Caffeine ingestion', 'placebo']","['cardiac parasympathetic reactivation', 'CAF3', 'autonomic reactivation', 'lnRMSSD for CAF3', 'CAF6', 'resting cardiac autonomic modulation and accelerates post-exercise autonomic recovery', 'Parasympathetic (lnRMSSD, primary outcome) and global HRV (lnSDNN, secondary outcome) were assessed at rest (i.e., pre-ingestion), 45-min post-ingestion, and 5-min and 35-min post-exercise recovery', 'CON', 'cardiac autonomic reactivity']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.499884,"Five-minutes after exercise, all treatments demonstrated significant declines in lnRMSSD vs. baseline (all, p <  0.001).","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sarshin', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran. amsarshin@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Naderi', 'Affiliation': 'Department of Sport Physiology, Boroujerd Branch, Islamic Azad University, Boroujerd, Iran.'}, {'ForeName': 'Carlos Janssen Gomes', 'Initials': 'CJG', 'LastName': 'da Cruz', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Foad', 'Initials': 'F', 'LastName': 'Feizolahi', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Faculty of Education, Department of Physical Education, Brandon University, Brandon, MB, R7A6A9, Canada.'}, {'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK, S4S0A2, Canada.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Mohammadgholian', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Jafari', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Eidi', 'Initials': 'E', 'LastName': 'Alijani', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Health and Kinesiology, Texas A & M University, College Station, TX, USA.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00373-6']
2213,32819394,"Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.","DESIGN


This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment.
METHODS


In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention.
RESULTS


Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4].
CONCLUSION


Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported.
TRIAL REGISTRATION


clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.",2020,"Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001.","['In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program', '208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters']","['comprehensive contraceptive counseling', 'home-based contraceptive delivery (condoms, pills, injection, implant']",['contraceptive initiation rates'],"[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C1443484', 'cui_str': 'Contraception care education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",208.0,0.0765249,"Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001.","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA. margo.harrison@cuanschutz.edu.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, Denver, CO, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}]",Reproductive health,['10.1186/s12978-020-00974-z']
2214,32819399,"The CARDIA-trial protocol: a multinational, prospective, randomized, clinical trial comparing transthoracic esophagectomy with transhiatal extended gastrectomy in adenocarcinoma of the gastroesophageal junction (GEJ) type II.","BACKGROUND


Adenocarcinoma of the gastroesophageal junction (GEJ) Siewert type II can be resected by transthoracic esophagectomy or transhiatal extended gastrectomy. Both allow for a complete tumor resection, yet there is an ongoing controversy about which surgical approach is superior with regards to quality of life, oncological outcomes and survival. While some studies suggest a better oncological outcome after transthoracic esophagectomy, others favor transhiatal extended gastrectomy for a better postoperative quality of life. To date, only retrospective studies are available, showing ambiguous results.
METHODS


This study is a multinational, multicenter, randomized, clinical superiority trial. Patients (n = 262) with a GEJ type II tumor resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy will be enrolled in the trial. Type II tumors are defined as tumors with their midpoint between ≤1 cm proximal and ≤ 2 cm distal of the top of gastric folds on preoperative endoscopy. Patients will be included in one of the participating European sites and are randomized to either transthoracic esophagectomy or transhiatal extended gastrectomy. The trial is powered to show superiority for esophagectomy with regards to the primary efficacy endpoint overall survival. Key secondary endpoints are complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness. Postoperative survival and quality of life will be followed-up for 24 months after discharge. Further survival follow-up will be conducted as quarterly phone calls up to 60 months.
DISCUSSION


To date, as level 1 evidence is lacking, there is no consensus on which surgery is superior and both surgeries are used to treat GEJ type II carcinoma worldwide. The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors. Several quality control measures were implemented in the protocol to ensure data reliability and increase the trial's significance. It is hypothesized that esophagectomy allows for a higher rate of radical resections and a more complete mediastinal lymph node dissection, resulting in a longer overall survival, while still providing an acceptable quality of life and cost-effectiveness.
TRIAL REGISTRATION


The trial was registered on August 2nd 2019 at the German Clinical Trials Register under the trial-ID DRKS00016923 .",2020,The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors.,"['Adenocarcinoma of the gastroesophageal junction (GEJ', 'Patients (n = 262) with a GEJ type II tumor resectable by both', 'in adenocarcinoma of the gastroesophageal junction (GEJ) type II', 'patients with GEJ type II tumors']","['transthoracic esophagectomy with transhiatal extended gastrectomy', 'transthoracic esophagectomy and transhiatal extended gastrectomy', 'transthoracic esophagectomy or transhiatal extended gastrectomy', 'transthoracic esophagectomy versus transhiatal extended gastrectomy']","['postoperative quality of life', 'complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness', 'Postoperative survival and quality of life']","[{'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",262.0,0.18429,The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors.,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Leers', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Knepper', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. laura.knepper@uk-koeln.de.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'van der Veen', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schröder', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Fuchs', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Schiller', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Zettelmeyer', 'Affiliation': 'Clinical Trials Centre Cologne, University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.'}, {'ForeName': 'Lodewijk A A', 'Initials': 'LAA', 'LastName': 'Brosens', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Quaas', 'Affiliation': 'Institute for Pathology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Jelle P', 'Initials': 'JP', 'LastName': 'Ruurda', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Hillegersberg', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}]",BMC cancer,['10.1186/s12885-020-07152-1']
2215,32819441,The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial.,"BACKGROUND


Lactation has a negative effect on female sexual function. Hormonal changes during lactation cause changes which might lead to dyspareunia, lack of libido, and anorgasmia. There are various pharmacological and non-pharmacological approaches to treat sexual dysfunction. While pharmacological treatment has multiple unwanted side effects, non-pharmacological therapies such as complementary medicine are a potential safer alternative. The aim of this study is to evaluate the effect of ear acupressure on sexual function of lactating women.
METHODS/DESIGN


This is a randomized clinical trial with a parallel sham control group. In this study, 76 lactating women between 6 months and 1 year after childbirth were referred to health care centers in Qazvin City and would be invited to participate. Participants will be divided into intervention (n = 38) and control (n = 38) groups using simple block randomization. Both intervention and sham control groups will be visited over 10 sessions within a 4-day interval. At each visit, the adhesives containing Vaccaria seed will be adhered for the intervention group, while non-latex-based adhesives with no Vaccaria seeds will be placed on the same ear acupoints for the sham control group. Selected ear acupoints include genitalia (two ear points), pelvic point, master shoulder, and posterior pituitary gland. The women will be asked to hold the seeds on their ears for 3 days and press each ear point three times a day for 20 s. After 3 days, they will be asked to remove the seeds from their ears and rest for 1 day. Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention. Also, Sexual Quality of Life as secondary outcome will be assessed using Sexual Quality of Life-Female (SQOL-F) before and 2 months after intervention. Data will be analyzed using repeated measure ANOVA at the significant level of 0.05.
DISCUSSION


This study is expected to support the impact of ear channel ear acupressure on sexual function in lactating women.
TRIAL REGISTRATION


Iranian Clinical Trial Registration Center IRCT20190626044028N1 . Registered on 16 August 2019.",2020,Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention.,"['76 lactating women between 6\u2009months and 1\xa0year after childbirth were referred to health care centers in Qazvin City and would be invited to participate', 'lactating women']","['ear acupressure', 'ear acupressure (auriculotherapy', 'channel ear acupressure']","['Female Sexual Function Index', 'Sexual Quality of Life-Female (SQOL-F', 'sexual function', 'Sexual Quality of Life', 'Sexual function']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C2350276', 'cui_str': 'Auriculotherapy'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",76.0,0.124762,Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention.,"[{'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Barghamadi', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoardi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, Iran.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Oleson', 'Affiliation': ""Emperor's College of Traditional Oriental Medicine, Santa Monica, CA, USA.""}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, Iran. nbahrami@qums.ac.ir.'}]",Trials,['10.1186/s13063-020-04663-x']
2216,32819444,"Comparison of McGrath, Pentax, and Macintosh laryngoscope in normal and cervical immobilized manikin by novices: a randomized crossover trial.","BACKGROUND


The aim of this study was to compare tracheal intubation performance regarding the time to intubation, glottic view, difficulty, and dental click, by novices using McGrath videolaryngoscope (VL), Pentax Airway Scope (AWS) and Macintosh laryngoscope in normal and cervical immobilized manikin models.
METHODS


Thirty-five anesthesia nurses without previous intubation experience were recruited. Participants performed endotracheal intubation in a manikin model at two simulated neck positions (normal and fixed neck via cervical immobilization), using three different devices three times each. Performance parameters included intubation time, success rate of intubation, Cormack Lehane laryngoscope grading, dental click, and subjective difficulty score.
RESULTS


Intubation time and success rate during first attempt were not significantly different between the 3 groups in normal airway manikin. In the cervical immobilized manikin, the intubation time was shorter (p = 0.012), and the success rate with the first attempt was significantly higher (p < 0.001) when using McGrath VL and Pentax AWS compared with Macintosh laryngoscope. Both VLs showed less difficulty score (p < 0.001) and more Cormack Lehane grade I (p < 0.001) in both scenarios. The incidence of dental clicks was higher with Macintosh laryngoscope compared with McGrath VL in cervical immobilized airway (p < 0.001).
CONCLUSIONS


McGrath VL and Pentax AWS did not show clinically significant decrease in intubation time, however, they achieved higher first attempt success rate, easier intubation and better glottis view compared with Macintosh laryngoscope by novices in a cervical immobilized manikin model. McGrath VL may reduce the risk of dental injury compared with Macintosh laryngoscope in cervical immobilized scenario.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03161730), May 22, 2017 https://clinicaltrials.gov/ct2/hom.",2020,"RESULTS


Intubation time and success rate during first attempt were not significantly different between the 3 groups in normal airway manikin.","['Thirty-five anesthesia', 'nurses without previous intubation experience were recruited', 'normal and cervical immobilized manikin by novices']","['McGrath, Pentax, and Macintosh laryngoscope', 'McGrath videolaryngoscope (VL), Pentax Airway Scope (AWS) and Macintosh laryngoscope', 'endotracheal intubation']","['incidence of dental clicks', 'difficulty score', 'tracheal intubation performance', 'intubation time, success rate of intubation, Cormack Lehane laryngoscope grading, dental click, and subjective difficulty score', 'intubation time', 'Intubation time and success rate', 'success rate']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",35.0,0.17611,"RESULTS


Intubation time and success rate during first attempt were not significantly different between the 3 groups in normal airway manikin.","[{'ForeName': 'In Kyong', 'Initials': 'IK', 'LastName': 'Yi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, 24, Namdong-Daero 774beon-gil, Namdong-gu, Incheon, 21565, Korea.'}, {'ForeName': 'Kyung Cheon', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, 24, Namdong-Daero 774beon-gil, Namdong-gu, Incheon, 21565, Korea.'}, {'ForeName': 'Ji Hyea', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea.'}, {'ForeName': 'Sang Kee', 'Initials': 'SK', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea. kjyeop@ajou.ac.kr.'}]",European journal of medical research,['10.1186/s40001-020-00435-0']
2217,32819445,Combined use of intravenous and topical tranexamic acid efficiently reduces blood loss in patients aged over 60 operated with a 2-level lumbar fusion.,"PURPOSE


The current study was conducted to assess the efficacy and safety of the intravenous (IV) administration combined with topical administration of tranexamic acid (TXA)in patients (aged over 60) scheduled for a 2-level lumbar fusion surgery.
METHODS


Two hundred eighty patients scheduled for a 2-level lumbar fusion surgery were randomized into four groups, including an IV group, a local group, a combined group, and a control group. Patients in the combined group, in the IV group, in the topical group, and in the control group were administrated with 15 mg/kg of IV-TXA + 2 g TXA in local, 15 mg/kg IV-TXA, 2 g TXA in local, and 100 ml IV, respectively. The results of total blood loss (TBL), maximum hemoglobin drop, the transfusion rate, and the number of allogeneic blood units were compared. Deep venous thrombosis (DVT) and pulmonary embolism (PE) events were monitored and recorded.
RESULTS


The TBL was 635.49 ± 143.60, 892.62 ± 166.85, 901.11 ± 186.25, and 1225.11 ± 186.25 mL for the combined group, the IV group, the topical group, and the control group, respectively (p = 0.015, p = 0.001, respectively). The average maximum hemoglobin drop in the four above groups was 2.18 ± 0.24, 2.80 ± 0.37, 2.40 ± 0.64, and 3.40 ± 1.32 g/dL, respectively. No PE event was reported during the follow-up. Although asymptomatic DVT events were reported by 1, 2, and 2 patients in the combined group, topical group, and control group, respectively, there is no intergroup difference.
CONCLUSIONS


The combined use of TXA effectively reduced the total blood loss and blood transfusion rate in patients aged over 60 scheduled for a 2-level lumbar fusion, without increasing the incidence of DVT and PE formation.",2020,"The combined use of TXA effectively reduced the total blood loss and blood transfusion rate in patients aged over 60 scheduled for a 2-level lumbar fusion, without increasing the incidence of DVT and PE formation.","['Two hundred eighty patients scheduled for a 2-level lumbar fusion surgery', 'patients (aged over 60) scheduled for a 2-level lumbar fusion surgery', 'patients aged over 60 operated with a 2-level lumbar fusion', 'patients aged over 60 scheduled for a 2-level lumbar fusion']","['intravenous and topical tranexamic acid', 'TXA', 'tranexamic acid (TXA)in', '15\u2009mg/kg of IV-TXA + 2\u2009g TXA']","['total blood loss and blood transfusion rate', 'total blood loss (TBL), maximum hemoglobin drop, the transfusion rate, and the number of allogeneic blood units', 'average maximum hemoglobin', 'efficacy and safety', 'Deep venous thrombosis (DVT) and pulmonary embolism (PE) events', 'incidence of DVT and PE formation', 'asymptomatic DVT events', 'blood loss']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439184', 'cui_str': 'Units of blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",280.0,0.0717007,"The combined use of TXA effectively reduced the total blood loss and blood transfusion rate in patients aged over 60 scheduled for a 2-level lumbar fusion, without increasing the incidence of DVT and PE formation.","[{'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Yanlu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China. drhuangyifei@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01758-8']
2218,32819923,Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial.,"INTRODUCTION


Postoperative ileus (POI), a common complication after surgery, severely affects postoperative recovery. It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI. This trial will evaluate the effects of pretreatment with TEAS on POI.
METHODS AND ANALYSIS


This will be a prospective, randomised controlled trial. American Society of Anesthesiologists (ASA) physical status classification I-III level patients, aged 18-75 years and scheduled for laparoscopic colon surgery, will be included in the study. It is planned that 146 subjects will be randomised to the TEAS and sham TEAS (STEAS) groups. The groups will undergo two sessions of TEAS/STEAS daily for 3 days before surgery, with a final TEAS/STEAS treatment 30 min before anaesthesia. The primary endpoint of the study will be time to first defaecation. Secondary endpoints will include time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3 days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression will be used to identify independent predictors of outcome measures.
ETHICS AND DISSEMINATION


This study has been approved by the Chinese Registered Clinical Trial Ethics Review Committee (No. ChiECRCT-20170084). The results of the trial will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


This study has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-INR-17013184).
TRIAL STATUS


The study was in the recruitment phase at the time of manuscript submission.",2020,It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI.,"['patients undergoing laparoscopic colon surgery', '146 subjects', 'American Society of Anesthesiologists (ASA) physical status classification I-III level patients, aged 18-75 years and scheduled for laparoscopic colon surgery']","['TEAS/STEAS', 'TEAS', 'transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation (TEAS', 'TEAS and sham TEAS (STEAS']","['time to first defaecation', 'postoperative ileus', 'time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3\u2009days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0429979', 'cui_str': 'Independent walking'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}]",146.0,0.238662,It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Dongli', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Anesthesiology, Wenzhou Medical University, the sixth Affiliated Hospital, Lishui, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yong', 'Affiliation': 'Research Institute of Acupuncture Anesthesia, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guijie', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Anesthesiology, Wenzhou Medical University, the sixth Affiliated Hospital, Lishui, China fanlihua_ls@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-030694']
2219,32835786,Attachment anxiety moderates the effect of oxytocin on negative emotion recognition: Evidence from eye-movement data.,"Valence-specific effects of oxytocin have been revealed in a selection of preceding studies, while others report that oxytocin could improve facial recognition, regardless of emotion valence. The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition. In this study, we used eye tracking to test whether attachment style moderates the effect of oxytocin on negative emotion recognition, which is crucial for social cognition. We employed a placebo-controlled, double-blind, within-participants design. The participants were 73 healthy individuals (41 men) who received a single dose of intranasal oxytocin (24 IU) on one occasion and a placebo dose on another occasion. Visual attention to the eye region was assessed on both occasions, through the completion of an emotion recognition task. Our results showed that oxytocin increased participants' eye gaze towards facial expressions. Among participants who received oxytocin, as opposed to a placebo, only individuals with high attachment anxiety displayed more eye gaze and less mouth gaze towards facial expression, regardless of emotion valence. Our findings confirmed that oxytocin increases gaze to the eye region, thus improving facial recognition, regardless of emotion valence, this relationship was moderated by attachment anxiety. Further, our results highlighted the importance of considering individual differences when evaluating the effects of oxytocin on emotion recognition.",2020,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.",['participants were 73 healthy individuals (41 men) who received a single dose of'],"['intranasal oxytocin', 'placebo', 'oxytocin']","['social behavior and cognition', 'eye gaze and less mouth gaze towards facial expression, regardless of emotion valence', 'emotion recognition', 'facial recognition, regardless of emotion valence', ""participants' eye gaze towards facial expressions"", 'eye gaze', 'negative emotion recognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0871740', 'cui_str': 'Face Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",73.0,0.296375,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.","[{'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Qingting', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China. Electronic address: chenxu@swu.edu.cn.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173015']
2220,32835880,Surface Treatment of RMGIC to Composite resin using different Photosensitizers and Lasers: A Bond Assessment of Closed Sandwich Restoration.,"AIM


The aim of present study was to assess and compare different conditioning methods (lased, PDT and conventional) on shear bond strength (SBS) of resin modified glass ionomer cement (RMGIC) bonded to composite (sandwich technique) MATERIAL AND METHODS: Fifty specimens were prepared from RMGIC and were packed in a teflon mould placed on glass slab. Through each of the glass slab the cement was light cured for 20 sec. Now samples were randomly allocated into five groups (n = 10) according to pre-treatment protocols. In group 1 RMGIC were conditioned with MBP using PDT, Samples in group 2 treated with Er,Cr:YSGG (ECYL), group 3 pre-treated with Nd:YAG laser (NYL), samples in group 4 surface conditioned with air abrasion (AA) and group 5 conditioned with 37% phosphoric acid (PA). Specimens after conditioning were rinsed with distilled water. Adhesive Adper Single Bond 2 was applied on treated surface of RMGIC and cured. Teflon mold was utilized to hold the composite Filtek Z250 in an incremental technique. For SBS testing all specimens were placed under shear knife edge at 1 K N at a speed of 0.5mm 2  until bond failure. Optical microscope was used to evaluate failure pattern at 10x magnification. The data of SBS in Megapascal were subjected to statistical test. Analysis of variance was followed by Post hoc test with level of significance at 5%.
RESULT


The maximum SBS was found in group 5 RMGIC conditioned with 37% PA (16.45 ± 0.32 MPa). Whereas, group 1 (MBP, PDT) demonstrated significantly lower bond integrity (9.82 ± 1.08 MPa) compared to all experimental groups. Bond integrity of RMGIC surface treated with MBP, PDT (9.82 ± 1.08 MPa), group 3 lased with NYL (11.47 ± 0.53 MPa) and samples in group 4 conditioned with AA (11.23 ± 0.47 MPa) were comparable (p > 0.05).
CONCLUSION


ECYL has a potential to be used for conditioning of RMGIC prior to composite restoration (sandwich technique). MBP at 100 mg/L deteriorates SBS of composite to RMGIC.",2020,"Bond integrity of RMGIC surface treated with MBP, PDT (9.82 ± 1.08 MPa), group 3 lased with NYL (11.47 ± 0.53 MPa) and samples in group 4 conditioned with AA (11.23 ± 0.47 MPa) were comparable (p > 0.05).
",[],"['conditioning methods (lased, PDT and conventional', 'MBP', 'Cr:YSGG (ECYL), group 3 pre-treated with Nd:YAG laser (NYL), samples in group 4 surface conditioned with air abrasion (AA) and group 5 conditioned with 37% phosphoric acid (PA', 'Er']","['bond integrity', 'shear bond strength (SBS', 'maximum SBS']",[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0014063', 'cui_str': 'Myelin basic protein'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",50.0,0.0278398,"Bond integrity of RMGIC surface treated with MBP, PDT (9.82 ± 1.08 MPa), group 3 lased with NYL (11.47 ± 0.53 MPa) and samples in group 4 conditioned with AA (11.23 ± 0.47 MPa) were comparable (p > 0.05).
","[{'ForeName': 'Ahmed Ali A', 'Initials': 'AAA', 'LastName': 'Ghubaryi', 'Affiliation': 'Dental Public Health, College of dentistry, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: ahmedaliaghubaryia@gmail.com.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Ingle', 'Affiliation': 'Dental Public Health, Department of Dental Public Health, College of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: naviningle154@gmail.com.'}, {'ForeName': 'Mohammed Abdul', 'Initials': 'MA', 'LastName': 'Basser', 'Affiliation': 'Department of Dental Public Health, College of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: mohammedabdulbasser@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101965']
2221,32835882,Transgingival photodynamic therapy (tg-aPDT) adjunctive to subgingival mechanical instrumentation in supportive periodontal therapy. A randomized controlled clinical study.,"BACKGROUND


Recent data from preclinical studies and case series suggest that transgingival irradiation with diode lasers may represent a novel modality for antimicrobial photodynamic therapy (aPDT). However, at present, there is lack of data from controlled clinical studies on the use of transgingival antimicrobial photodynamic therapy (tg-aPDT) in the treatment of periodontitis.
OBJECTIVE


To evaluate the clinical effects of tg-aPDT used in conjunction with nonsurgical mechanical instrumentation during supportive periodontal therapy (SPT).
MATERIALS AND METHODS


Forty stage II and III periodontitis patients enrolled in SPT were randomly assigned to two groups of equal size. At baseline, study sites had to show sites with pocket probing depth (PPD) of ≥ 5 mm and Bleeding on Probing (BOP). Full mouth and site-specific Plaque-Index scores (PI), BOP, PPD, and Clinical Attachment Level (CAL) were recorded at baseline (BL), three months (3 M), and 6 months (6 M), respectively. The primary outcome variable was the change in the number of sites with BOP. Treatment was performed under local anaesthesia after random allocation to one of the following groups 1) Subgingival scaling and root planing (SRP) + tg-aPDT (test) or 2) SRP alone (control).
RESULTS


Thirty-nine patients completed the study. Full mouth PI and BOP improved over six month, however without statistically significant difference between the groups. At 6 M, BOP-levels were statistically significantly lower in test sites (25.0%) compared to the control sites (65.0%), (p < 0.025). PPD improved in both groups with comparable mean values at 3 M (PPD test: 5.21 ± 0.92 mm; PPD control: 4.45 ± 1.36 mm) and 6 M (PPD test: 5.11 ± 1.10 mm; PPD control: 4.35 ± 1.14 mm). Additionally, CAL slightly improved in both groups with comparable mean values at 3 M (CAL test: 6.79 ± 1.72 mm; CAL control: 5.30 ± 2.43 mm) and 6 M (CAL test: 6.26 ± 1.70 mm; CAL control: 5.50 ± 2.33 mm).
CONCLUSIONS


Within its limits, the present results appear to indicate that the use of tg-aPDT adjunctive to SRP may represent a new modality for controlling inflammation and further bleeding in residual periodontal pockets.",2020,"At 6 M, BOP-levels were statistically significantly lower in test sites (25.0%) compared to the control sites (65.0%), (p < 0.025).","['Thirty-nine patients completed the study', 'Forty stage II and III periodontitis patients enrolled in SPT']","['Transgingival photodynamic therapy (tg-aPDT) adjunctive to subgingival mechanical instrumentation', 'tg-aPDT', 'Subgingival scaling and root planing (SRP) + tg-aPDT (test) or 2) SRP alone (control', 'transgingival irradiation with diode lasers', 'transgingival antimicrobial photodynamic therapy (tg-aPDT']","['Full mouth PI and BOP', 'PPD', 'number of sites with BOP', 'Full mouth and site-specific Plaque-Index scores (PI), BOP, PPD, and Clinical Attachment Level (CAL', 'BOP-levels', 'pocket probing depth (PPD) of ≥ 5\u2009mm and Bleeding on Probing (BOP']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0086958', 'cui_str': 'Subgingival scaling'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0445108', 'cui_str': 'Number of sites'}, {'cui': 'C0449604', 'cui_str': 'Specific site'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.103157,"At 6 M, BOP-levels were statistically significantly lower in test sites (25.0%) compared to the control sites (65.0%), (p < 0.025).","[{'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Schär', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Ramseier', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Mettraux', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Switzerland. Electronic address: anton.sculean@zmk.unibe.ch.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101971']
2222,32835895,A twelve-month follow-up of an information communication technology delivered intervention for children with autism spectrum disorder living in regional Australia.,"This study investigated the long-term follow-up of an information communication techonology based intervention, the Therapeutic Outcomes By You application, for children with autism spectrum disorder living in regional Australia. Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes By You were assessed at least 12 months post-intervention to determine the maintenance or continued improvement of their language and social communication skills. Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.",2020,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","['Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes', 'children with autism spectrum disorder living in regional Australia']",[],"['receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",15.0,0.0425543,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Parsons', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia. Electronic address: dave.parsons@curtin.edu.au.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Vaz', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Hoe', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Kids are Kids!, Australia.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia; Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, United Kingdom.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103743']
2223,32492040,Risk factors for blood transfusion in traumatic and postpartum hemorrhage patients: Analysis of the CRASH-2 and WOMAN trials.,"BACKGROUND


Hemorrhage is a leading cause of death after trauma and childbirth. In response to severe hemorrhage, bleeding patients often receive transfusions of red blood cells, plasma, platelets, or other blood components. We examined risk factors for transfusion in acute severe bleeding in two trials of over 20,000 patients to better understand factors associated with transfusion likelihood.
STUDY DESIGN AND METHODS


We conducted a cohort analysis of data from the CRASH-2 and WOMAN trials, two multinational trials that recruited patients with traumatic and postpartum hemorrhage, respectively. For each trial, we examined the effect of 10 factors on blood transfusion likelihood. Univariate and multivariate Poisson regressions were used to analyze the relationship between risk factors and blood transfusion.
RESULTS


Of the 20,207 traumatic hemorrhage patients, 10,232 (51%) received blood components. Of the 20,060 women with postpartum hemorrhage, 10,958 (55%) received blood components. For patients who suffered from traumatic hemorrhage, those greater than three hours from injury to hospitalization were more likely to be transfused (ARR 1.37; 95% CI, 1.20-1.56). Postpartum hemorrhage patients had an increased likelihood of transfusion if they gave birth outside the hospital (ARR 1.30; 95% CI 1.22-1.39), gave birth more than three hours before hospitalization (ARR 1.09; 95% CI 1.01-1.17), had a Caesarean section (ARR 1.16; 95% CI 1.08-1.25), and if they had any identifiable causes of hemorrhage other than uterine atony.
CONCLUSION


Several risk factors are associated with an increased likelihood of transfusion in traumatic and postpartum hemorrhage patients. Altering modifiable factors, by reducing time from injury or childbirth to hospitalization, for example, might be able to reduce transfusions and their complications.
TRIAL REGISTRATION


CRASH-2 is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258 and South African Clinical Trial Register DOH-27-0607-1919. WOMAN is registered as ISRCTN76912190, ClinicalTrials.gov NCT00872469, PACTR201007000192283, and EudraCT number 2008-008441-38.",2020,"Postpartum hemorrhage patients had an increased likelihood of transfusion if they gave birth outside the hospital (ARR 1.30; 95% CI 1.22-1.39), gave birth more than three hours before hospitalization (ARR 1.09; 95% CI 1.01-1.17), had a Caesarean section (ARR 1.16; 95% CI 1.08-1.25), and if they had any identifiable causes of hemorrhage other than uterine atony.
","['20,060 women with postpartum hemorrhage, 10,958 (55%) received blood components', '20,207 traumatic hemorrhage patients', 'We conducted a cohort analysis of data from the CRASH-2 and WOMAN trials, two multinational trials that recruited patients with traumatic and postpartum hemorrhage, respectively', 'traumatic and postpartum hemorrhage patients', 'Postpartum hemorrhage patients']",[],"['blood components', 'Caesarean section', 'blood transfusion likelihood', 'likelihood of transfusion', 'traumatic hemorrhage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0085430', 'cui_str': 'Transfusion of blood component'}, {'cui': 'C0040797', 'cui_str': 'Traumatic hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086027', 'cui_str': 'Cohort Analysis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]",[],"[{'cui': 'C0085430', 'cui_str': 'Transfusion of blood component'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040797', 'cui_str': 'Traumatic hemorrhage'}]",20060.0,0.478782,"Postpartum hemorrhage patients had an increased likelihood of transfusion if they gave birth outside the hospital (ARR 1.30; 95% CI 1.22-1.39), gave birth more than three hours before hospitalization (ARR 1.09; 95% CI 1.01-1.17), had a Caesarean section (ARR 1.16; 95% CI 1.08-1.25), and if they had any identifiable causes of hemorrhage other than uterine atony.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kolin', 'Affiliation': 'Department of Population Health, Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, England, United Kingdom.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Department of Population Health, Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, England, United Kingdom.'}, {'ForeName': 'Adenike', 'Initials': 'A', 'LastName': 'Bello', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Rizwana', 'Initials': 'R', 'LastName': 'Chaudhri', 'Affiliation': 'Department Obstetrics and Gynecology, Rawalpindi Medical University, Rawalpindi, Pakistan.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Bates', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, England, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Department of Population Health, Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, England, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0233274']
2224,32823974,"The Effect of a Multivitamin and Mineral Supplement on Immune Function in Healthy Older Adults: A Double-Blind, Randomized, Controlled Trial.","Older adults are at increased risk for vitamin and mineral deficiencies that contribute to age-related immune system decline. Several lines of evidence suggest that taking a multi-vitamin and mineral supplement (MVM) could improve immune function in individuals 55 and older. To test this hypothesis, we provided healthy older adults with either an MVM supplement formulated to improve immune function (Redoxon ®  VI, Singapore) or an identical, inactive placebo control to take daily for 12 weeks. Prior to and after treatment, we measured (1) their blood mineral and vitamin status (i.e., vitamin C, zinc and vitamin D); (2) immune function (i.e., whole blood bacterial killing activity, neutrophil phagocytic activity, and reactive oxygen species production); (3) immune status (salivary IgA and plasma cytokine/chemokine levels); and (4) self-reported health status. MVM supplementation improved vitamin C and zinc status in blood and self-reported health-status without altering measures of immune function or status or vitamin D levels, suggesting that healthy older adults may benefit from MVM supplementation. Further development of functional assays and larger study populations should improve detection of specific changes in immune function after supplementation in healthy older adults. Clinical Trials Registration: ClinicalTrials.gov #NCT02876315.",2020,"MVM supplementation improved vitamin C and zinc status in blood and self-reported health-status without altering measures of immune function or status or vitamin D levels, suggesting that healthy older adults may benefit from MVM supplementation.","['individuals 55 and older', 'Healthy Older Adults', 'healthy older adults with either an', 'healthy older adults', 'Older adults']","['Multivitamin and Mineral Supplement', 'MVM supplementation', 'multi-vitamin and mineral supplement (MVM', 'MVM supplement formulated to improve immune function (Redoxon ®  VI, Singapore) or an identical, inactive placebo control']","['blood mineral and vitamin status (i.e., vitamin C, zinc and vitamin D); (2) immune function (i.e., whole blood bacterial killing activity, neutrophil phagocytic activity, and reactive oxygen species production); (3) immune status (salivary IgA and plasma cytokine/chemokine levels); and (4) self-reported health status', 'immune function', 'vitamin C and zinc status', 'Immune Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0556112', 'cui_str': 'Mineral supplement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.187722,"MVM supplementation improved vitamin C and zinc status in blood and self-reported health-status without altering measures of immune function or status or vitamin D levels, suggesting that healthy older adults may benefit from MVM supplementation.","[{'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Fantacone', 'Affiliation': 'Linus Pauling Institute, Department of Biochemistry & Biophysics, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Malcolm B', 'Initials': 'MB', 'LastName': 'Lowry', 'Affiliation': 'Linus Pauling Institute, Department of Microbiology, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Uesugi', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Michels', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Jaewoo', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Leonard', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Sean K', 'Initials': 'SK', 'LastName': 'Gombart', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gombart', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bobe', 'Affiliation': 'Linus Pauling Institute, Department of Animal & Rangeland Sciences, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Gombart', 'Affiliation': 'Linus Pauling Institute, Department of Biochemistry & Biophysics, Oregon State University, Corvallis, OR 97331, USA.'}]",Nutrients,['10.3390/nu12082447']
2225,32824040,Interactive Low Back Pain Intervention Module Based on the Back School Program: A Cluster-Randomized Experimental Study Evaluating Its Effectiveness among Nurses in Public Hospitals.,"The prevalence of low back pain (LBP) among nurses is high. The main aim of this study was to evaluate the effectiveness of an interactive LBP module based on the Back School Program in improving Oswestry Disability Scores (ODSs) among nurses in government hospitals in Penang, Malaysia. A cluster-randomized experimental study was conducted within four public hospitals. These hospitals were randomized to intervention and control groups. A total of 284 nurses from the selected hospitals were randomly selected (142 in each group). An interactive LBP intervention module based on the Back School Program was designed and prescribed. Both the intervention and control groups were assessed using the Oswestry Disability Questionnaire at baseline and at the end of the third and sixth weeks. Out of 284 participants, 281 completed this study. A between-group comparison revealed that ODSs were significantly lower in the intervention group than in the control group at the ends of the third ( p  = 0.006) and sixth weeks ( p  < 0.001). Within-group changes revealed a significant reduction in ODSs within the intervention group from baseline to the third ( p  < 0.001) and sixth weeks ( p  < 0.001) of the intervention. This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.",2020,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","['Back School Program', 'nurses in government hospitals in Penang, Malaysia', 'four public hospitals', '284 nurses from the selected hospitals were randomly selected (142 in each group', '284 participants, 281 completed this study', 'Nurses in Public Hospitals']","['Interactive Low Back Pain Intervention Module', 'interactive LBP module based on the Back School Program']","['Oswestry Disability Scores (ODSs', 'Oswestry Disability Questionnaire', 'ODSs', 'low back pain (LBP']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",284.0,0.0391314,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","[{'ForeName': 'Mohd Ismail', 'Initials': 'MI', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Izani Uzair', 'Initials': 'IU', 'LastName': 'Zubair', 'Affiliation': 'Penang Health State Department, 33 Pengkalan Weld, George Town, Penang 10300, Malaysia.'}, {'ForeName': 'Mohd Nazri', 'Initials': 'MN', 'LastName': 'Shafei', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Mohd Izmi', 'Initials': 'MI', 'LastName': 'Ahmad', 'Affiliation': 'Hospital Pulau Pinang, Jalan Residensi, George Town, Penang 10990, Malaysia.'}, {'ForeName': 'Najib Majdi', 'Initials': 'NM', 'LastName': 'Yaacob', 'Affiliation': 'Units of Biostatistics and Research Methodology, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165916']
2226,32824061,Promoting a Healthy Lifestyle through Mindfulness in University Students: A Randomized Controlled Trial.,"The present study explored the effects of a second-generation mindfulness-based intervention known as  flow meditation  ( Meditación-Fluir ) in the improvement of healthy life behaviors. A sample of university students ( n  = 51) in Spain were randomly assigned to a seven-week mindfulness treatment or a waiting list control group. Results showed that compared to the control group, individuals in the mindfulness group demonstrated significant improvements across all outcome measures including healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits. There were differences between males and females in some of these variables and a better effect of the treatment was evident in the females of the experimental group when compared to the males. The  flow meditation  program shows promise for fostering a healthy lifestyle, thus decreasing behaviors related to maladaptive eating, tobacco, alcohol, and cannabis consumption as well as negative rest habits in university students. This mindfulness program could significantly contribute to the treatment of eating disorders and addictions, wherein negative emotional states and impulsivity are central features of the condition.",2020,"Results showed that compared to the control group, individuals in the mindfulness group demonstrated significant improvements across all outcome measures including healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits.","['healthy life behaviors', 'A sample of university students ( n  = 51) in Spain', 'university students', 'Healthy Lifestyle through Mindfulness in University Students']","['second-generation mindfulness-based intervention known as  flow meditation  ( Meditación-Fluir ', 'seven-week mindfulness treatment or a waiting list control group']","['healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0587121', 'cui_str': 'Between meals'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",,0.0158131,"Results showed that compared to the control group, individuals in the mindfulness group demonstrated significant improvements across all outcome measures including healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits.","[{'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Soriano-Ayala', 'Affiliation': 'Department of Education, Universidad de Almería, 04120 Almeria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Amutio', 'Affiliation': 'Department of Work Relations and Social Work, University of the Basque Country (UPV/EHU), 48940 Bilbao, Spain.'}, {'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Franco', 'Affiliation': 'Department of Psychology, Universidad de Almería, 04120 Almeria, Spain.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Mañas', 'Affiliation': 'Department of Psychology, Universitat Oberta de Catalunya, 08018 Barcelona, Spain.'}]",Nutrients,['10.3390/nu12082450']
2227,32824168,Visual Attentional Training Improves Reading Capabilities in Children with Dyslexia: An Eye Tracker Study During a Reading Task.,"Dyslexia is a specific disorder in reading abilities. The aim of this study was to explore whether a short visual attentional training could improve reading capabilities in children with reading disorders by changing their oculomotor characteristics. Two groups (G1 and G2) of 25 children with reading disabilities and who are matched in IQ (intelligence quotient), sex, and age participated in the study. The allocation of a subject to a specific group (G1 = experimental group; G2 = control group) was generated in an unpredictable random sequence. The reading task was recorded twice for G1, i.e., before (T1) and after (T2) 10 min of visual attentional training. Training consisted of oculomotor tasks (saccades and pursuits movements) and searching tasks (three different exercises). For G2, the two reading tasks at T1 and T2 were done at an interval of 10 min instead. We found that at T1, oculomotor performances during reading were statistically similar for both groups of children with reading disabilities (G1 and G2). At T2, the group G1 only improved oculomotor capabilities significantly during reading; in particular, children read faster, and their fixation time was shortest. We conclude that short visual attentional training could improve the cortical mechanisms responsible for attention and reading capabilities. Further studies on a larger number of dyslexic children will be necessary in order to explore the effects of different training types on the visual attentional span given its important role on the orienting and focusing visuospatial attention and on the oculomotor performance in children with dyslexia.",2020,"We found that at T1, oculomotor performances during reading were statistically similar for both groups of children with reading disabilities (G1 and G2).","['Children with Dyslexia', 'children with dyslexia', '25 children with reading disabilities and who are matched in IQ (intelligence quotient), sex, and age participated in the study', 'children with reading disorders by changing their oculomotor characteristics']","['visual attentional training', 'short visual attentional training', 'oculomotor tasks (saccades and pursuits movements) and searching tasks (three different exercises', 'Visual Attentional Training']","['fixation time', 'reading capabilities', 'oculomotor capabilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0036019', 'cui_str': 'Saccadic eye movement'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",25.0,0.0216168,"We found that at T1, oculomotor performances during reading were statistically similar for both groups of children with reading disabilities (G1 and G2).","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Caldani', 'Affiliation': 'UMR 7114 MoDyCo, CNRS-Université Paris Nanterre, 92000 Nanterre, France.'}, {'ForeName': 'Christophe-Loïc', 'Initials': 'CL', 'LastName': 'Gerard', 'Affiliation': 'Child and Adolescent Psychiatry Department, Robert Debré Hospital, 75019 Paris, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Peyre', 'Affiliation': 'Child and Adolescent Psychiatry Department, Robert Debré Hospital, 75019 Paris, France.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Bucci', 'Affiliation': 'UMR 7114 MoDyCo, CNRS-Université Paris Nanterre, 92000 Nanterre, France.'}]",Brain sciences,['10.3390/brainsci10080558']
2228,32824185,Dorsolateral Prefrontal Cortex Activity during a Brain Training Game Predicts Cognitive Improvements after Four Weeks' Brain Training Game Intervention: Evidence from a Randomized Controlled Trial.,"BACKGROUND


Recent studies have demonstrated that brain activities using NIRS (near-infrared spectroscopy) at baseline during cognitive tasks (e.g., N-back task) can predict the cognitive benefits of a cognitive training. In this study, we investigated whether brain activities during brain training game (BT) at baseline would predict benefits to cognitive functions after the intervention period.
METHODS


In a four-week double-blinded randomized control trial (RCT) 72 young adults were randomly assigned to one of the two groups: participants in the BT group played specific game, called the Brain Age. Participants in an active control group (ACT) played the puzzle game Tetris. We measured brain activity during the training games using two channel NIRS before the intervention period. Cognitive functions were tested before and after the four-week intervention period.
RESULTS


The BT showed significant improvements in inhibition, processing speed, and working memory performance compared to ACT. The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed.
DISCUSSION


This randomized control trial first provides scientific evidence that DLPFC activities during BT at baseline can predict cognitive improvements after a four-week intervention period.",2020,"The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed.
",['72 young adults'],"['active control group (ACT) played the puzzle game', 'brain training game (BT', 'BT group played specific game, called the Brain Age']","['Cognitive functions', 'brain activity', 'inhibition, processing speed, and working memory performance', 'left and right DLPFC (dorsolateral prefrontal cortex) brain activities']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",72.0,0.157709,"The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed.
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Natasha Yuriko Dos Santos', 'Initials': 'NYDS', 'LastName': 'Kawata', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Robin Maximilian', 'Initials': 'RM', 'LastName': 'Himmelmeier', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Smart Aging Research Center (S.A.R.C.), Tohoku University, Seiryo-machi 4-1, Sendai 980-8575, Japan.'}]",Brain sciences,['10.3390/brainsci10080560']
2229,32824190,The Smartphone-Assisted Intervention Improved Perception of Nutritional Status among Middle School Students.,"Misperception of nutritional status is common and hinders the progress of childhood obesity prevention. This study aimed to examine the effectiveness of a smartphone-assisted intervention to improve student and parental perception of students' nutritional status (underweight, normal weight, overweight, obese). We conducted a parallel-group controlled trial with a non-randomized design in three junior middle schools of Beijing, China in 2019. One school was allocated to the intervention group and two schools to the control group. A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial. The 3-month intervention included three components: health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application. Schools in the control group continued their usual practice. Primary outcomes included the student and parental accurate perception of students' nutritional status. The percentage of students' accurate perception of their own nutritional status in the intervention group increased from 49.0% to 59.2% from baseline to three months, whereas it decreased from 64.1% to 58.1% in the control group; the adjusted odds ratio (OR) between the two groups was 1.71 (95% confidence interval (CI): 1.13, 2.59). The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05). The study findings provided a brief approach for improving perception of nutritional status among middle school students.",2020,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"['Middle School Students', 'middle school students', 'three junior middle schools of Beijing, China in 2019', 'A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial', ""students' nutritional status (underweight, normal weight, overweight, obese""]","['Smartphone-Assisted Intervention', 'smartphone-assisted intervention', ""health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application""]","[""student and parental accurate perception of students' nutritional status"", ""parental perception of students' nutritional status"", ""percentage of students' accurate perception of their own nutritional status""]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",3.0,0.0150395,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"[{'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Shen', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17165932']
2230,32824408,Lower Postprandial Thermogenic Response to an Unprocessed Whole Food Meal Compared to an Iso-Energetic/Macronutrient Meal Replacement in Young Women: A Single-Blind Randomized Cross-Over Trial.,"In contrast to ultra-processed foods that are associated with increased weight gain and obesity risk, nutritionally engineered dietary supplements, including meal replacement (MR) bars and shakes, are generally promoted as healthy. Limited data is available comparing the metabolic and hunger responses of whole food (WF) versus MR meals. The purpose of this study was to directly compare the thermic effect (TEM), respiratory exchange ratio (RER), hunger/taste ratings, and glucose response of two different breakfast meals containing MR and WF products in young healthy women. Eight volunteers completed two iso-caloric (529 kcals)/macronutrient (50% carbohydrates; 26% fat; 24% protein) test meals in a single-blind, randomized crossover design: (1) whole food meal; or (2) meal replacement. TEM was significantly higher following MR compared with WF (percent mean difference: 7.76 ± 3.78%; absolute mean difference: 0.053 ± 0.026 kcal/minute,  p  = 0.048), whereas WF substrate utilization demonstrated lower carbohydrate oxidation (RER) than MR (mean difference: -0.024 ± 0.008,  p  = 0.005). No differences existed for blood glucose response and feelings of hunger, desire to eat, and satiety among trials. Consumption of an MR meal increases postprandial thermogenesis and RER compared to a WF meal, which may impact weight control and obesity risk over the long-term.",2020,"TEM was significantly higher following MR compared with WF (percent mean difference: 7.76 ± 3.78%; absolute mean difference: 0.053 ± 0.026 kcal/minute,  p  = 0.048), whereas WF substrate utilization demonstrated lower carbohydrate oxidation (RER) than MR (mean difference: -0.024 ± 0.008,  ","['young healthy women', 'Young Women']","['MR meal', 'Unprocessed Whole Food Meal', 'whole food meal; or (2) meal replacement', 'Macronutrient Meal Replacement']","['thermic effect (TEM), respiratory exchange ratio (RER), hunger/taste ratings, and glucose response', 'Lower Postprandial Thermogenic Response', 'postprandial thermogenesis and RER', 'weight gain and obesity risk', 'TEM', 'carbohydrate oxidation (RER', 'blood glucose response and feelings of hunger, desire to eat, and satiety']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",8.0,0.0715045,"TEM was significantly higher following MR compared with WF (percent mean difference: 7.76 ± 3.78%; absolute mean difference: 0.053 ± 0.026 kcal/minute,  p  = 0.048), whereas WF substrate utilization demonstrated lower carbohydrate oxidation (RER) than MR (mean difference: -0.024 ± 0.008,  ","[{'ForeName': 'Alex E', 'Initials': 'AE', 'LastName': 'Mohr', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ramos', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Tavarez', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Arciero', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]",Nutrients,['10.3390/nu12082469']
2231,32824416,"Physical Activity, Sedentary Behavior, and Sleep Quality in Adults with Primary Hypertension and Obesity before and after an Aerobic Exercise Program: EXERDIET-HTA Study.","BACKGROUND


The purposes of the study were to: analyze, by objective (accelerometry) and subjective (International Physical Activity Questionnaire, IPAQ) methodologies, the physical activity (PA) and sedentary behavior (SB) in healthy adults (HEALTHY,  n  = 30) and individuals with primary hypertension (HTN) and overweight/obesity ( n  = 218); assess the effects of an aerobic exercise intervention on physical activity (PA), sedentary behavior (SB), and sleep quality in the HTN group; and evaluate the relationship between objectively measured and subjectively reported PA and SB.
METHODS


The measurements were performed before a 16-week exercise intervention period in both HEALTHY and HTN groups and after the intervention period only in the HTN group, randomized to attention control or exercise training (ExT) subgroups.
RESULTS


The HEALTHY group showed more moderate-to-vigorous PA ( p  < 0.05) and better sleep quality ( p  < 0.05) than the HTN group, but no difference in SB. After the intervention, HTN participants' PA and SB, objectively measured by accelerometry, were unchanged, but increased PA and decreased SB ( p  < 0.05) were observed through IPAQ in ExT. The intervention was effective in improving sleep quality in HTN participants.
CONCLUSIONS


The differences in moderate-to-vigorous PA and SB may be useful in defining the health profile of a population. The supervised aerobic exercise program was effective in increasing PA, reducing SB, and improving sleep quality in overweight/obese adults with HTN. Accelerometer-measured and self-reported data were not comparable, but complementary.",2020,"The HEALTHY group showed more moderate-to-vigorous PA ( p  < 0.05) and better sleep quality ( p  < 0.05) than the HTN group, but no difference in SB.","['overweight/obese adults with HTN', 'healthy adults (HEALTHY,  n  = 30) and individuals with primary hypertension (HTN) and overweight/obesity ( n  = 218', 'Adults with Primary Hypertension and Obesity before and after an Aerobic Exercise Program']","['aerobic exercise intervention', 'exercise intervention period in both HEALTHY and HTN', 'attention control or exercise training (ExT) subgroups', 'supervised aerobic exercise program']","['SB', 'moderate-to-vigorous PA', 'Physical Activity, Sedentary Behavior, and Sleep Quality', 'physical activity (PA), sedentary behavior (SB), and sleep quality', 'PA and decreased SB', 'objective (accelerometry) and subjective (International Physical Activity Questionnaire, IPAQ) methodologies, the physical activity (PA) and sedentary behavior (SB', 'sleep quality']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]",,0.0243219,"The HEALTHY group showed more moderate-to-vigorous PA ( p  < 0.05) and better sleep quality ( p  < 0.05) than the HTN group, but no difference in SB.","[{'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martinez Aguirre-Betolaza', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Mujika', 'Affiliation': 'GIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Physical Exercise Research Group, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, The University of Mississippi, Oxford, MS 38677, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}]","Life (Basel, Switzerland)",['10.3390/life10080153']
2232,32824425,Changes in the Diversity of Human Skin Microbiota to Cosmetic Serum Containing Prebiotics: Results from a Randomized Controlled Trial.,"Prebiotic treatment may rebalance the skin microbiota by regulating the growth of harmful and beneficial microorganisms. In this randomized, double-blind, placebo-controlled clinical trial (N = 60), we evaluated the effects of a cosmetic serum containing galacto-oligosaccharides (GOS) on the balance of the skin microbiota by measuring various skin parameters. The skin water-holding capacity between the control (ND) and experimental (NF) groups was significantly different after 8 weeks of serum treatment ( p  < 0.05). Similarly, changes in transepidermal water loss (TEWL) and the erythema index in the ND and NF groups were significantly different ( p  < 0.05). Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05). The mean form factor, Shannon index, and  Pediococcus  population were significantly increased in the post-NF group compared with those in the post-ND group ( p  < 0.05). Finally, in the ND group, water-holding capacity was positively correlated with  Enhydrobacter , whereas  Enterobacteriaceae  was negatively correlated with TEWL in the NF group. These results suggest that GOS inhibit the growth of harmful skin microbes and increase the population of beneficial microbes.",2020,"Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05).",[],"['cosmetic serum containing galacto-oligosaccharides (GOS', 'GOS', 'Prebiotic treatment', 'placebo']","['wrinkle depth and  Staphylococcus aureus  population', 'water-holding capacity', 'mean form factor, Shannon index, and  Pediococcus  population', 'transepidermal water loss (TEWL) and the erythema index', 'skin water-holding capacity']",[],"[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030762', 'cui_str': 'Pediococcus'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",60.0,0.0290086,"Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05).","[{'ForeName': 'Ki-Bae', 'Initials': 'KB', 'LastName': 'Hong', 'Affiliation': 'Department of Integrated Biomedical and Life Sciences, Graduate School, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Yang Hee', 'Initials': 'YH', 'LastName': 'Hong', 'Affiliation': ""Department of Beauty Art, Suwon Women's University, Suwon 16632, Korea.""}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Jung', 'Affiliation': 'Department of Home Economic Education, Jeonju University, Jeonju 55069, Korea.'}, {'ForeName': 'Kyungae', 'Initials': 'K', 'LastName': 'Jo', 'Affiliation': 'BK21Plus, College of Health Science, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Hyung Joo', 'Initials': 'HJ', 'LastName': 'Suh', 'Affiliation': 'Department of Integrated Biomedical and Life Sciences, Graduate School, Korea University, Seoul 02841, Korea.'}]",Journal of personalized medicine,['10.3390/jpm10030091']
2233,32824480,PHAGE-2 Study: Supplemental Bacteriophages Extend  Bifidobacterium animalis  subsp.  lactis  BL04 Benefits on Gut Health and Microbiota in Healthy Adults.,"Probiotics are increasingly used by consumers and practitioners to reduce gastrointestinal (GI) distress and improve gut function. Here, we sought to determine whether the addition of supplemental bacteriophages (PreforPro) could enhance the effects of a common probiotic,  Bifidobacterium animalis  subsp.  lactis  ( B. lactis ) on GI health. A total of 68 participants were enrolled in a 4-week, randomized, parallel-arm, double-blind, placebo-controlled trial where primary outcomes included self-assessments of GI health, a daily stool log, and 16s rRNA analysis of gut microbial populations. We observed within-group improvements in GI inflammation ( p  = 0.01) and a trending improvement in colon pain ( p  = 0.08) in individuals consuming  B. lactis  with PreforPro, but not in the group consuming only the probiotic. There was also a larger increase in  Lactobacillus  and short-chain fatty acid-producing microbial taxa detected in the stool of participants taking PreforPro with  B. lactis  compared to the probiotic alone. Overall, these results suggest the addition of PreforPro as a combination therapy may alter gut ecology to extend the GI benefits of consuming  B. lactis  or other probiotics.",2020,"We observed within-group improvements in GI inflammation ( p  = 0.01) and a trending improvement in colon pain ( p  = 0.08) in individuals consuming  B. lactis  with PreforPro, but not in the group consuming only the probiotic.","['A total of 68 participants', 'Healthy Adults']","['supplemental bacteriophages (PreforPro', 'PreforPro', 'placebo']","['colon pain', 'Lactobacillus  and short-chain fatty acid-producing microbial taxa', 'self-assessments of GI health, a daily stool log, and 16s rRNA analysis of gut microbial populations', 'GI inflammation', 'gastrointestinal (GI) distress and improve gut function']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0004651', 'cui_str': 'Bacterial virus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535950', 'cui_str': 'Gastrointestinal inflammation'}, {'cui': 'C0548823', 'cui_str': 'Distress gastrointestinal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",68.0,0.182107,"We observed within-group improvements in GI inflammation ( p  = 0.01) and a trending improvement in colon pain ( p  = 0.08) in individuals consuming  B. lactis  with PreforPro, but not in the group consuming only the probiotic.","[{'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Grubb', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Wrigley', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Kimberley E', 'Initials': 'KE', 'LastName': 'Freedman', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Yuren', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Allegra R', 'Initials': 'AR', 'LastName': 'Vazquez', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Roxanne E', 'Initials': 'RE', 'LastName': 'Trotter', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Taylor C', 'Initials': 'TC', 'LastName': 'Wallace', 'Affiliation': 'Think Healthy Group, 1301 20th Street, NW, #413, Washington, DC 20036, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Functional Foods & Human Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Weir', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}]",Nutrients,['10.3390/nu12082474']
2234,32824483,"The Effect of Long-Term  Aronia   melanocarpa  Extract Supplementation on Cognitive Performance, Mood, and Vascular Function: A Randomized Controlled Trial in Healthy, Middle-Aged Individuals.","Cognitive decline is associated with lifestyle-related factors such as overweight, blood pressure, and dietary composition. Studies have reported beneficial effects of dietary anthocyanins on cognition in older adults and children. However, the effect of anthocyanin-rich  Aronia melanocarpa  extract (AME) on cognition is unknown. Therefore, this study aimed to determine the effect of long-term supplementation with AME on cognitive performance, mood, and vascular function in healthy, middle-aged, overweight adults. In a randomized double-blind placebo-controlled parallel study, 101 participants either consumed 90 mg AME, 150 mg AME, or placebo for 24 weeks. The grooved pegboard test, number cross-out test, and Stroop test were performed as measures for psychomotor speed, attention, and cognitive flexibility. Mood was evaluated with a visual analogue scale, serum brain-derived neurotrophic factor (BDNF) was determined, and vascular function was assessed by carotid ultrasounds and blood pressure measurements. AME improved psychomotor speed compared to placebo (90 mg AME: change = -3.37;  p  = 0.009). Furthermore, 150 mg AME decreased brachial diastolic blood pressure compared to 90 mg AME (change = 2.44;  p  = 0.011), but not compared to placebo. Attention, cognitive flexibility, BDNF, and other vascular parameters were not affected. In conclusion, AME supplementation showed an indication of beneficial effects on cognitive performance and blood pressure in individuals at risk of cognitive decline.",2020,AME improved psychomotor speed compared to placebo (90 mg AME: change = -3.37;  p  = 0.009).,"['individuals at risk of cognitive decline', 'older adults and children', 'Healthy, Middle-Aged Individuals', 'healthy, middle-aged, overweight adults', '101 participants either consumed 90 mg']","['Long-Term  Aronia   melanocarpa  Extract Supplementation', 'AME supplementation', 'anthocyanin-rich  Aronia melanocarpa  extract (AME', 'AME', 'dietary anthocyanins', 'AME, 150 mg AME, or placebo', 'placebo']","['Cognitive Performance, Mood, and Vascular Function', 'cognitive performance, mood, and vascular function', 'cognitive performance and blood pressure', 'AME improved psychomotor speed', 'carotid ultrasounds and blood pressure measurements', 'Attention, cognitive flexibility, BDNF, and other vascular parameters', 'psychomotor speed, attention, and cognitive flexibility', 'visual analogue scale, serum brain-derived neurotrophic factor (BDNF', 'brachial diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1449661', 'cui_str': 'Aronia melanocarpa'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",101.0,0.34269,AME improved psychomotor speed compared to placebo (90 mg AME: change = -3.37;  p  = 0.009).,"[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Ahles', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Yala R', 'Initials': 'YR', 'LastName': 'Stevens', 'Affiliation': 'BioActor BV, Gaetano Martinolaan 85, 6229 GS Maastricht, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vauzour', 'Affiliation': 'Biomedical Research Centre, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich NR4 7TJ, UK.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Adam', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'de Groot', 'Affiliation': 'Imagelabonline & Cardiovascular, 4117 GV Erichem, The Netherlands.'}, {'ForeName': 'Jogchum', 'Initials': 'J', 'LastName': 'Plat', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}]",Nutrients,['10.3390/nu12082475']
2235,32824709,Short and Long-Term Trainability in Older Adults: Training and Detraining Following Two Years of Multicomponent Cognitive-Physical Exercise Training.,"Despite the benefits of multicomponent physical-cognitive training programs (MC Cog TPs), lower training intensities in the concurrent approach, and bigger heterogeneity with aging, suggest the need for long-term analyses, with special attention to training and detraining in older adults. The present study aims to examine these training/detraining effects in a two year MC Cog TP, looking for specific dynamics in the trainability of their physical and cognitive capacities. The intervention was divided into four periods: T1, T2 (8 months of training each), and D1, D2 (3.5 months of detraining plus 0.5 of testing each). Twenty-five healthy seniors (70.82 ± 5.18 years) comprised the final sample and were assessed for cardiovascular fitness (6-minutes walking test), lower-limbs strength (30-seconds chair-stand test) and agility (8-feet timed up-and-go test). Inhibition (Stroop test) was considered for executive function. Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility). Strength and cardiovascular fitness were more sensitive to detraining, whilst agility proved to have larger training retentions. Inhibition followed an initial similar trend, but it was the only variable to improve along D2 (d = 0.52), and changes were not significant within periods. Notwithstanding aging, and the exercise cessation in D2, physical and cognitive status remained enhanced two years later compared to baseline, except for lower-limb strength. According to these results, basic physical capacities are very sensitive to training/detraining, deserving continuous attention (especially strength). Both reducing detraining periods and complementary resistance training should be considered. Additionally, physical enhancements following MC cog TPs may help cognition maintenance during detraining.",2020,"Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility).","['Older Adults', 'older adults', 'Twenty-five healthy seniors (70.82 ± 5.18 years']","['Training and Detraining Following Two Years of Multicomponent Cognitive-Physical Exercise Training', 'multicomponent physical-cognitive training programs (MC Cog TPs']","['Physical and cognitive status', 'cardiovascular fitness (6-minutes walking test), lower-limbs strength (30-seconds chair-stand test) and agility', 'Strength and cardiovascular fitness', 'physical function (mainly strength and agility', 'cognition maintenance', 'exercise cessation in D2, physical and cognitive status']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0289863', 'cui_str': 'tissue polypeptide specific antigen'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",25.0,0.0109849,"Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Forte', 'Affiliation': 'Statistics and Operational Research Department, University of Valencia, 46100 Burjassot, Valencia, Spain.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance & Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17165984']
2236,32824720,"A Comparison of a Standard Macintosh Blade Laryngoscope, Pentax-AWS Videolaryngoscope and Intubrite Videolaryngoscope for Tracheal Intubation in Manikins in Sitting and Prone Positions: A Randomized Cross-Over Study.","BACKGROUND


Intubation of a patient in different positions may be done not only in emergency settings, but also in routine anesthesia (e.g., prone position for lumbar spine surgery).
METHODS


The aim of the study was to compare the classic Macintosh blade laryngoscope with two videolaryngoscopes: the Pentax-AWS and the Intubrite in a simulated scenario of a manikin placed in a sitting and prone position. Additionally, intubation with the use of all three devices was performed in a standard supine position as the control group. The time of intubation and the pressure exerted on the tongue was assessed. The ANOVA Friedman (analysis of variance) and Wilcoxon with Bonferroni correction tests were used for statistical analysis.
RESULTS


The time of intubation in a prone position was significantly shorter for the Pentax-AWS videolaryngoscope compared to the Macintosh and the Intubrite. There were no significant differences in the obtained results of the evaluated devices in sitting and standard positions. The lowest pressure exerted on the tongue was with the Pentax-AWS, followed by the Intubrite and the Macintosh laryngoscopes.
CONCLUSIONS


The use of the Pentax-AWS was associated with faster tracheal intubation, creating lower pressure on tongue when compared with standard Macintosh and Intubrite laryngoscopes in both prone and sitting positions.",2020,The time of intubation in a prone position was significantly shorter for the Pentax-AWS videolaryngoscope compared to the Macintosh and the Intubrite.,['Tracheal Intubation in Manikins in Sitting and Prone Positions'],"['Standard Macintosh Blade Laryngoscope, Pentax-AWS Videolaryngoscope and Intubrite Videolaryngoscope']","['time of intubation in a prone position', 'time of intubation and the pressure']","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0347406,The time of intubation in a prone position was significantly shorter for the Pentax-AWS videolaryngoscope compared to the Macintosh and the Intubrite.,"[{'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Gaszyński', 'Affiliation': 'Department of Anesthesiology and Intensive Therapy, Medical University of Lodz, 90-419 Lodz, Poland.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10080603']
2237,32824722,The Impact of a Multi-Pronged Intervention on Students' Perceptions of School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption.,"School lunch programs provide an opportunity to improve students' diets. We sought to determine the impact of a multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education) on secondary students' perceptions of school-lunch quality and convenience and fruit and vegetable intake. Surveys ( n  = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed. We investigated change in school-lunch perceptions and lunchtime and daily fruit and vegetable consumption from 2016 to 2018. Among 8th graders, perceptions that school lunch tastes good and that school lunch was enough to make students feel full increased 0.2 points (on a 5-point scale;  p  < 0.01) in intervention schools relative to control schools. Among 10th graders, lunchtime fruit and vegetable consumption increased 6% in intervention relative to control schools ( p  < 0.05 and  p  < 0.01 respectively). Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01). This study provides important evidence on the limited effect of design approaches in the absence of meal changes. We observed only modest changes in school lunch perceptions and fruit and vegetable consumption that were not consistent across grades, suggesting that additional efforts are needed to improve school-lunch uptake.",2020,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01).,"['Surveys ( n  = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed', ""students' diets""]","['Multi-Pronged Intervention', 'multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education']","['lunchtime fruit and vegetable consumption', 'school-lunch uptake', 'Daily fruit intake', 'school-lunch perceptions and lunchtime and daily fruit and vegetable consumption', 'school lunch perceptions and fruit and vegetable consumption', 'school-lunch quality and convenience and fruit and vegetable intake', 'School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0871930', 'cui_str': 'Teacher Education'}]","[{'cui': 'C0585039', 'cui_str': 'Lunch time'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0183678,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01).,"[{'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Machado', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Lorrene D', 'Initials': 'LD', 'LastName': 'Ritchie', 'Affiliation': 'Nutrition Policy Institute, University of California Agriculture and Natural Resources, Berkeley, CA 94704, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Thompson', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Madsen', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17165987']
2238,32824731,A Guide to Nature Immersion: Psychological and Physiological Benefits.,"Nature exposure has been renowned for its positive physiological and psychological benefits. Recent years have seen a rise in nature immersion programs that make use of Guided Forest Therapy walks in a standard sequence of sensory awareness activities to expose participants to natural environments in a safe but effective manner. The study aimed to compare the efficacy of guided versus unguided nature immersion, upon three dependent variables of mood, nature connectedness and heartrate. 51 participants were assigned to either guided or unguided nature immersion. Nature connectedness (Connectedness to Nature Scale, CNS), Environmental Identity Scale, EID short form) and mood (Positive and Negative Affect Scale, PANAS) were assessed before and after nature immersion, while heart rate was tracked continuously by a wristwatch heart rate tracker throughout the 2-h experience. Demographics and general health practice (GHP) information were also collected. A mixed model ANOVA revealed that nature connectedness and mood (but not heart rate) improved post-immersion for all participants. Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate. Comparing within the five segments within the standard sequence in the guided condition, the third and fifth segments revealed a significantly lower heart rate compared to the baseline heart rate.",2020,"Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate.",['51 participants'],"['guided or unguided nature immersion', 'guided versus unguided nature immersion']","['Nature connectedness (Connectedness to Nature Scale, CNS), Environmental Identity Scale, EID short form) and mood (Positive and Negative Affect Scale, PANAS', 'Demographics and general health practice (GHP) information', 'nature connectedness, mood or heart rate', 'heart rate']",[],"[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",51.0,0.0195299,"Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate.","[{'ForeName': 'Pei Yi', 'Initials': 'PY', 'LastName': 'Lim', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Dillon', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}, {'ForeName': 'Peter K H', 'Initials': 'PKH', 'LastName': 'Chew', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17165989']
2239,32824736,"The Impact of Formulation on Lutein, Zeaxanthin, and  meso -Zeaxanthin Bioavailability: A Randomised Double-Blind Placebo-Controlled Study.","Lutein (L), zeaxanthin (Z), and  meso -zeaxanthin (MZ) have been the focus of research and commercial interest for their applications in human health. Research into formulations to enhance their bioavailability is merited. This 6 month randomised placebo-controlled trial involving 81 healthy volunteers compared the bioavailability of different formulations of free L, Z, and MZ in sunflower or omega-3 oil versus L, Z, and MZ diacetates (Ld, Zd, and MZd) in a micromicellar formulation. Fasting serum carotenoids, macular pigment, and skin carotenoid score were analysed at baseline and 6 months. Serum L, Z, and MZ concentrations increased in all active interventions compared to placebo ( p  < 0.001 to  p  = 0.008). The diacetate micromicelle formulation exhibited a significantly higher mean response in serum concentrations of Z and MZ compared to the other active interventions ( p  = 0.002 to 0.019). A micromicellar formulation with solubilised Z and MZ diacetates is a promising technology advancement that enhances the bioavailability of these carotenoids when compared to traditional carotenoid formulations (ISRCTN clinical trial registration number: ISRCTN18206561).",2020,"Serum L, Z, and MZ concentrations increased in all active interventions compared to placebo ( p  < 0.001 to  p  = 0.008).",['81 healthy volunteers'],"['placebo', 'free L, Z, and MZ in sunflower or omega-3 oil versus L, Z, and MZ diacetates (Ld, Zd, and MZd', 'Placebo', 'Lutein (L), zeaxanthin (Z), and  meso -zeaxanthin (MZ']","['Fasting serum carotenoids, macular pigment, and skin carotenoid score', 'Lutein, Zeaxanthin, and  meso -Zeaxanthin Bioavailability', 'serum concentrations of Z and MZ', 'Serum L, Z, and MZ concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C3884591', 'cui_str': 'meso-zeaxanthin'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C3884591', 'cui_str': 'meso-zeaxanthin'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",81.0,0.131769,"Serum L, Z, and MZ concentrations increased in all active interventions compared to placebo ( p  < 0.001 to  p  = 0.008).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Green-Gomez', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Prado-Cabrero', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Moran', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Power', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Laura G', 'Initials': 'LG', 'LastName': 'Gómez-Mascaraque', 'Affiliation': 'Teagasc Food Research Centre, Moorepark, Fermoy, P61 C996 Co. Cork, Ireland.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Stack', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Nolan', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9080767']
2240,32824771,High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation in Hypercapnic Respiratory Failure: A Randomized Clinical Trial.,"High-flow oxygen through nasal cannula (HFNC) provides adequate oxygenation and can be an alternative to noninvasive ventilation (NIV) for patients with hypoxemic respiratory failure. The aim of the present study was to assess the efficacy of HFNC versus NIV in hypercapnic respiratory failure. Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2  ≥ 45 mmHg) were randomized assigned into two groups, i.e., an intervention group (use of HFNC, n = 20) and a control group (use of NIV, n = 20). During their hospitalization in the Intensive Care Unit, vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG) were closely monitored on admission, after 24 h and at discharge. No difference between the two groups regarding the duration of hospitalization and the use of HFNC or NIV was observed ( p  > 0.05). On admission, the two groups did not differ in terms of gender, age, body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases ( p  > 0.05). Respiratory rate in the HFNC group was lower than in the NIV group ( p  = 0.023). At discharge, partial carbon dioxide arterial pressure (PaCO 2 ) in the HFNC group was lower than in the NIV group (50.8 ± 9.4 mmHg versus 59.6 ± 13.9 mmHg,  p  = 0.024). The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.",2020,The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"['patients with hypoxemic respiratory failure', '45 mmHg', 'Hypercapnic Respiratory Failure', 'hypercapnic respiratory failure', 'Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2  ≥']","['High-flow oxygen through nasal cannula (HFNC', 'High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation', 'HFNC']","['partial carbon dioxide arterial pressure (PaCO 2 ', 'duration of hospitalization and the use of HFNC or NIV', 'vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG', 'body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases', 'Respiratory rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0542864,The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"[{'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Papachatzakis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Occupational Therapy, School of Health and Caring Sciences, University of West Attica, 12243 Athens, Greece.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Kontogiannis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Trakada', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}]",International journal of environmental research and public health,['10.3390/ijerph17165994']
2241,30138237,Countermovement Jump Reliability Performed With and Without an Arm Swing in NCAA Division 1 Intercollegiate Basketball Players.,"Heishman, AD, Daub, BD, Miller, RM, Freitas, EDS, Frantz, BA, and Bemben, MG. Countermovement jump reliability performed with and without an arm swing in NCAA Division 1 intercollegiate basketball players. J Strength Cond Res 34(2): 546-558, 2020-The countermovement jump (CMJ) is routinely used in athlete performance to quantify adaptions to training, as well as monitor neuromuscular readiness and fatigue. However, controversy remains in whether to incorporate an arm swing during the CMJ (CMJ AS) or keep the hands placed on the hips (CMJ NAS). Incorporating the arms provides a higher degree of sport-specificity that may yield improved reliability, especially in skilled jumpers. By contrast, the hands-on-hips approach isolates lower extremity force production and eliminates potential arm-swing variation. Therefore, the purpose of this study was to establish the reliability of CMJ typical (CMJ-TYP), CMJ concentric alternative (CMJ-Conc-ALT), and CMJ eccentric alternative (CMJ-Ecc-ALT) variables obtained during the CMJ AS and CMJ NAS. Twenty-two (men = 14, women = 8) NCAA Division 1 collegiate basketball players performed 3 CMJ AS and 3 CMJ NAS on a force plate, in a randomized order. To assess the test-retest reliability, participants returned 1 week later to perform 3 additional CMJ AS and 3 CMJ NAS. Intraclass correlation coefficient (ICC) and coefficient of variation (CV) were used to assess intersession and intrasession reliability for the various CMJ variables. A majority of CMJ-TYP and several CMJ-Conc-ALT and CMJ-Ecc-ALT variables exhibited adequate intersession and intrasession reliability (ICC > 0.700 and CV <10%) during both the CMJ AS and the CMJ NAS. Countermovement jump AS may provide more pertinent information about long-term changes in sport-specific performance, whereas the CMJ NAS may be more beneficial for detecting acute changes in neuromuscular fatigue and athlete readiness.",2020,"546-558, 2020-The countermovement jump (CMJ) is routinely used in athlete performance to quantify adaptions to training, as well as monitor neuromuscular readiness and fatigue.","['Twenty-two (men = 14, women = 8', 'J Strength Cond Res 34(2']","['2020-The countermovement jump (CMJ', 'CMJ typical (CMJ-TYP), CMJ concentric alternative (CMJ-Conc-ALT), and CMJ eccentric alternative (CMJ-Ecc-ALT', 'CMJ AS and 3 CMJ NAS']","['Heishman, AD, Daub, BD, Miller, RM, Freitas, EDS, Frantz, BA, and Bemben, MG', 'Intraclass correlation coefficient (ICC) and coefficient of variation (CV']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C0027446', 'cui_str': 'National Academy of Sciences (U.S.)'}]","[{'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",22.0,0.0206165,"546-558, 2020-The countermovement jump (CMJ) is routinely used in athlete performance to quantify adaptions to training, as well as monitor neuromuscular readiness and fatigue.","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Departmetn of Health and Exercise Science, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Bryce D', 'Initials': 'BD', 'LastName': 'Daub', 'Affiliation': 'Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Departmetn of Health and Exercise Science, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Departmetn of Health and Exercise Science, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Frantz', 'Affiliation': 'Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Departmetn of Health and Exercise Science, University of Oklahoma, Norman, Oklahoma.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002812']
2242,30602342,Validation of a new 2.5D radiographic index evaluating acetabular coverage using ACX software.,"BACKGROUND


Several radiographic signs have been described to assess acetabular coverage. However, plain radiographs only have 2 dimensions (2D) and cannot accurately show acetabular coverage.
QUESTIONS/PURPOSES


We developed the ACX Dynamics software to calculate the radial centre-edge angle (RCEA), which represents the acetabular coverage of the femoral head at each acetabular edge point on the radial plane. This study validated the accuracy of the RCEA, as calculated by ACX Dynamics, as a quantitative parameter for acetabular coverage.
PATIENTS AND METHODS


We reviewed the anteroposterior (AP) pelvic radiographs and computed tomography (CT) of 650 hips from 325 patients who presented with chief complaint of symptoms at the hip joint. Of 109 hip radiographs (68 patients) that satisfied the criteria, 50 randomised, blinded AP pelvic radiographs were chosen. We determined the absolute RCEA difference (°) [= RCEA ACX (°) - RCEA CT (°)], determined the correlation between RCEA ACX (°) and RCEA CT (°), and examined the RCEA's intra-observer and inter-observer reliability in 50 hips.
RESULTS


The absolute RCEA difference from A45° to P75° was 1.9-3.1°. The correlation between the RCEA ACX (°) and RCEA CT (°) was > 0.7 in all lesions ( p  < 0.001). Using the intraclass correlation coefficient, the intra-observer reliability of the RCEA was 0.83-0.97 in the whole range, which is a highly reproducible and reasonable parameter, and the inter-observer reliability was > 0.80 in A45°-P0°.
CONCLUSIONS


The RCEA ACX (°) can be used as a simple quantitative parameter for assessing acetabular coverage using AP pelvic radiograph.",2020,The correlation between the RCEA ACX (°) and RCEA CT (°) was > 0.7 in all lesions ( p  < 0.001).,"['109 hip radiographs (68 patients', 'We reviewed the anteroposterior (AP) pelvic radiographs and computed tomography (CT) of 650 hips from 325 patients who presented with chief complaint of symptoms at the hip joint']",[],"['absolute RCEA difference', 'absolute RCEA difference (°) [= RCEA ACX (°) - RCEA CT (°']","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]",[],"[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",650.0,0.0369905,The correlation between the RCEA ACX (°) and RCEA CT (°) was > 0.7 in all lesions ( p  < 0.001).,"[{'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Nishikino', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Koyama', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hoshino', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700018820883']
2243,30878146,Recall accuracy for the symptoms of a major depressive episode among clinical trial participants.,"For patients with major depressive disorder (MDD), approaches to treatment differ for those with a single versus recurrent episodes. Based on studies of community samples, however, accuracy is low for identifying past episodes. Recall accuracy among clinical samples with a well-defined major depressive episode (MDE) has not been examined previously. We evaluated episode recall accuracy in 79 MDD patients in follow-up of the Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) study at 12- and 24-month time-points after starting treatment. Using the Structured Clinical Interview for DSM-IV, patients were asked to recall whether they had been experiencing the nine criterion symptoms of an MDE at the time of their intake assessment. Accuracy of recall for the index MDE was high, with 95% of patients at month 12 and 85% at month 24 recalling sufficient symptoms to meet the diagnostic criteria. Recall accuracy for specific symptoms varied considerably, from >90% for dysphoria and anhedonia, to 55% for psychomotor and weight/appetite changes. For the thoughts of death/suicide criterion, patients with erroneous recall were significantly more likely to recall having had the symptom at the intake evaluation (though they had denied it at the time) than vice versa (p < .007). Patients who have participated in a clinical trial are likely to recall accurately a past MDE up to two years prior. Optimal vigilance for suicidal ideation for treatment-naïve patients should include a combination of self-report and clinician assessments.",2019,"Recall accuracy for specific symptoms varied considerably, from >90% for dysphoria and anhedonia, to 55% for psychomotor and weight/appetite changes.","['patients with major depressive disorder (MDD', 'Patients who have participated in a clinical trial are likely to recall accurately a past MDE up to two years prior', '79 MDD patients in follow-up of the Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) study at 12- and 24-month time-points after starting treatment']",[],"['episode recall accuracy', 'Recall accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0556969', 'cui_str': 'times/month'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",[],"[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",79.0,0.0270943,"Recall accuracy for specific symptoms varied considerably, from >90% for dysphoria and anhedonia, to 55% for psychomotor and weight/appetite changes.","[{'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: bdunlop@emory.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Granros', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Mletzko-Crowe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': 'Institute for Early Life Adversity Research, University of Texas Dell Medical School in Austin, Austin, TX, USA.'}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Mayberg', 'Affiliation': 'Departments of Neurology and Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'W Edward', 'Initials': 'WE', 'LastName': 'Craighead', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA; Department of Psychology, Emory University, Atlanta, GA, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.03.008']
2244,30894507,Effects of Kuntai capsules on knee osteoarthritis in postmenopausal women.,,2019,,['postmenopausal women'],['Kuntai capsules'],['knee osteoarthritis'],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4507708', 'cui_str': 'kuntai capsule'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]",,0.0205103,,"[{'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Jining No.1 People's Hospital, Jining, China.""}, {'ForeName': 'Kaiyue', 'Initials': 'K', 'LastName': 'Du', 'Affiliation': ""Emergency Department of Internal Medicine, Jining No.1 People's Hospital, Jining, China.""}, {'ForeName': 'Xinglin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Jining No.1 People's Hospital, Jining, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Jining No.1 People's Hospital, Jining, China - 457954721@qq.com.""}]",Panminerva medica,['10.23736/S0031-0808.19.03614-0']
2245,30906300,"HLA Class II Genes  HLA-DRB1, HLA-DPB1 , and  HLA-DQB1  Are Associated With the Antibody Response to Inactivated Japanese Encephalitis Vaccine.","Aim:  The objective of this study was to evaluate the association of the human leukocyte antigen (HLA) class II genes  HLA-DRB1, HLA-DPB1 , and  HLA-DQB1  with the humoral immune response elicited by inactivated Japanese encephalitis (JE) vaccine (IJEV).  Methods:  A total of 373 individuals aged 3-12 years in the Inner Mongolia Autonomous Region in China, who received two doses of IJEV at 0 and 7 days, were enrolled in the current study. Based on the individuals' specific JE virus (JEV)-neutralizing antibodies (NAbs), they were divided into a seropositive and a seronegative group.  HLA-DRB1, HLA-DPB1 , and  HLA-DQB1  were genotyped using a sequencing-based typing method. Next, the association of the HLA class II genes and their haplotypes with antibody response was evaluated.  Results:  Based on NAbs, a total of 161 individuals were classified as seropositive and 212 as seronegative.  DQB1   *   02:01  was significantly associated with JEV seropositivity ( P  < 0.001, OR = 0.364, 95% CI: 0.221-0.600), while  DQB1   *   02:02  was significantly associated with JEV seronegativity ( P  = 5.03 × 10 -6 , OR = 7.341, 95% CI: 2.876-18.736). The haplotypes  DRB1   *   07:01-DPB1   *   04:01-DQB1   *   02:01, DRB1   *   15:01-DPB1   *   02:01-DQB1   *   06:02, DRB1   *   07:01-DQB1   *   02:01 , and  DPB1   *   02:01-DQB1   *   06:02  were very frequent in the seropositive group, while  DRB1   *   07:01-DPB1   *   17:01-DQB1   *   02:02, DRB1   *   07:01-DQB1   *   02:02 , and  DPB1   *   17:01-DQB1   *   02:02  were very frequent in the seronegative group. The presence of  DRB1   *   01:01, DRB1   *   04:05, DRB1   *   09:01, DRB1   *   12:02, DRB1   *   13:02 , and  DRB1   *   14:01  was associated with a higher geometric mean titer (GMT) of NAbs than that of  DRB1   *   11:01  at the  DRB1  locus ( P  < 0.05). At the  DPB1  locus, the presence of  DPB1   *   05:01  was associated with higher GMTs than that of  DPB1   *   02:01  and  DPB1   *   13:01  ( P  < 0.05), and the presence of  DPB1   *   04:01  and  DPB1   *   09:01  was associated with higher GMTs than that of  DPB1   *   13:01  ( P  < 0.05).  Conclusions:  The present study suggests that HLA class II genes may influence the antibody response to IJEV.",2019,14:01  was associated with a higher geometric mean titer (GMT) of NAbs than that of  DRB1   *   11:01  at the  DRB1  locus ( P  < 0.05).,"['161 individuals were classified as seropositive and 212 as seronegative', '373 individuals aged 3-12 years in the Inner Mongolia Autonomous Region in China, who received two doses of IJEV at 0 and 7 days, were enrolled in the current study']",['inactivated Japanese encephalitis (JE) vaccine (IJEV'],"['DQB1', 'HLA Class II Genes', 'DPB1', 'HLA-DRB1, HLA-DPB1 , and  HLA-DQB1', 'higher geometric mean titer (GMT) of NAbs', 'JEV seropositivity', 'JEV seronegativity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0771080', 'cui_str': 'Japanese Encephalitis Vaccines'}]","[{'cui': 'C0017349', 'cui_str': 'MHC Class II Genes'}, {'cui': 'C0122040', 'cui_str': 'HLA-DRB1 Antigen'}, {'cui': 'C0122007', 'cui_str': 'Antigen of human leukocyte DPB1'}, {'cui': 'C0122020', 'cui_str': 'HLA-DQB1 antigen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",373.0,0.0217144,14:01  was associated with a higher geometric mean titer (GMT) of NAbs than that of  DRB1   *   11:01  at the  DRB1  locus ( P  < 0.05).,"[{'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Chuanying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Ziyun', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}]",Frontiers in immunology,['10.3389/fimmu.2019.00428']
2246,30930896,"Differential Patterns of IgG Subclass Responses to  Plasmodium falciparum  Antigens in Relation to Malaria Protection and RTS,S Vaccination.","Naturally acquired immunity (NAI) to  Plasmodium falciparum  malaria is mainly mediated by IgG antibodies but the subclasses, epitope targets and effector functions have not been unequivocally defined. Dissecting the type and specificity of antibody responses mediating NAI is a key step toward developing more effective vaccines to control the disease. We investigated the role of IgG subclasses to malaria antigens in protection against disease and the factors that affect their levels, including vaccination with RTS,S/AS01E. We analyzed plasma and serum samples at baseline and 1 month after primary vaccination with RTS,S or comparator in African children and infants participating in a phase 3 trial in two sites of different malaria transmission intensity: Kintampo in Ghana and Manhiça in Mozambique. We used quantitative suspension array technology (qSAT) to measure IgG 1-4  responses to 35  P. falciparum  pre-erythrocytic and blood stage antigens. Our results show that the pattern of IgG response is predominantly IgG1 or IgG3, with lower levels of IgG2 and IgG4. Age, site and RTS,S vaccination significantly affected antibody subclass levels to different antigens and susceptibility to clinical malaria. Univariable and multivariable analysis showed associations with protection mainly for cytophilic IgG3 levels to selected antigens, followed by IgG1 levels and, unexpectedly, also with IgG4 levels, mainly to antigens that increased upon RTS,S vaccination such as MSP5 and MSP1 block 2, among others. In contrast, IgG2 was associated with malaria risk. Stratified analysis in RTS,S vaccinees pointed to novel associations of IgG4 responses with immunity mainly involving pre-erythrocytic antigens upon RTS,S vaccination. Multi-marker analysis revealed a significant contribution of IgG3 responses to malaria protection and IgG2 responses to malaria risk. We propose that the pattern of cytophilic and non-cytophilic IgG antibodies is antigen-dependent and more complex than initially thought, and that mechanisms of both types of subclasses could be involved in protection. Our data also suggests that RTS,S efficacy is significantly affected by NAI, and indicates that RTS,S vaccination significantly alters NAI.",2019,"Age, site and RTS,S vaccination significantly affected antibody subclass levels to different antigens and susceptibility to clinical malaria.","['Kintampo in Ghana and Manhiça in Mozambique', 'African children and infants participating in a phase 3 trial in two sites of different malaria transmission intensity']","['RTS', 'RTS,S or comparator', 'quantitative suspension array technology (qSAT']","['RTS,S efficacy']","[{'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0287317,"Age, site and RTS,S vaccination significantly affected antibody subclass levels to different antigens and susceptibility to clinical malaria.","[{'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Santano', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Chenjerai', 'Initials': 'C', 'LastName': 'Jairoce', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Ubillos', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dosoo', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nana Aba', 'Initials': 'NA', 'LastName': 'Williams', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Díez-Padrisa', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'Ayestaran', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Valim', 'Affiliation': 'Department of Osteopathic Medical Specialties, Michigan State University, East Lansing, MI, United States.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lanar', 'Affiliation': 'Malaria Vaccine Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States.'}, {'ForeName': 'Virander', 'Initials': 'V', 'LastName': 'Chauhan', 'Affiliation': 'Malaria Group, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India.'}, {'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Chitnis', 'Affiliation': 'Malaria Group, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India.'}, {'ForeName': 'Sheetij', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Malaria Vaccine Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Angov', 'Affiliation': 'Malaria Vaccine Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Gamain', 'Affiliation': ""Unité Biologie Intégrée du Globule Rouge, Laboratoire d'Excellence GR-Ex, UMR_S1134, Inserm, INTS, Université Sorbonne Paris Cité, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Coppel', 'Affiliation': 'Infection and Immunity Program, Monash Biomedicine Discovery Institute, Department of Microbiology, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Reiling', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Gaur', 'Affiliation': 'Malaria Group, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cavanagh', 'Affiliation': 'Ashworth Laboratories, Centre for Immunity, Infection and Evolution, School of Biological Sciences, Institute of Immunology and Infection Research, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gyan', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Campo', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}]",Frontiers in immunology,['10.3389/fimmu.2019.00439']
2247,30973981,Population pharmacokinetic model and Bayesian estimator for 2 tacrolimus formulations in adult liver transplant patients.,,2019,,['adult liver transplant patients'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0276238,,"[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Riff', 'Affiliation': 'Department of Pharmacology and Toxicology, CHU Limoges, Limoges, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Debord', 'Affiliation': 'Department of Pharmacology and Toxicology, CHU Limoges, Limoges, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Monchaud', 'Affiliation': 'Department of Pharmacology and Toxicology, CHU Limoges, Limoges, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Marquet', 'Affiliation': 'Department of Pharmacology and Toxicology, CHU Limoges, Limoges, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Woillard', 'Affiliation': 'Department of Pharmacology and Toxicology, CHU Limoges, Limoges, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.13960']
2248,31026084,"Pharmacokinetic and pharmacodynamic modelling for renal function dependent urinary glucose excretion effect of ipragliflozin, a selective sodium-glucose cotransporter 2 inhibitor, both in healthy subjects and patients with type 2 diabetes mellitus.","AIMS


To provide a model-based prediction of individual urinary glucose excretion (UGE) effect of ipragliflozin, we constructed a pharmacokinetic/pharmacodynamic (PK/PD) model and a population PK model using pooled data of clinical studies.
METHODS


A PK/PD model for the change from baseline in UGE for 24 hours (ΔUGE 24h  ) with area under the concentration-time curve from time of dosing to 24 h after administration (AUC 24h  ) of ipragliflozin was described by a maximum effect model. A population PK model was also constructed using rich PK sampling data obtained from 2 clinical pharmacology studies and sparse data from 4 late-phase studies by the NONMEM $PRIOR subroutine. Finally, we simulated how the PK/PD of ipragliflozin changes in response to dose regime as well as patients' renal function using the developed model.
RESULTS


The estimated individual maximum effect were dependent on fasting plasma glucose and renal function, except in patients who had significant UGE before treatment. The PK of ipragliflozin in type 2 diabetes mellitus (T2DM) patients was accurately described by a 2-compartment model with first order absorption. The population mean oral clearance was 9.47 L/h and was increased in patients with higher glomerular filtration rates and body surface area. Simulation suggested that medians (95% prediction intervals) of AUC 24h  and ΔUGE 24h  were 5417 (3229-8775) ng·h/mL and 85 (51-145) g, respectively. The simulation also suggested a 1.17-fold increase in AUC 24h  of ipragliflozin and a 0.76-fold in ΔUGE 24h  in T2DM patients with moderate renal impairment compared to those with normal renal function.
CONCLUSIONS


The developed models described the clinical data well, and the simulation suggested mechanism-based weaker antidiabetic effect in T2DM patients with renal impairment.",2019,"The estimated individual maximum effect were dependent on fasting plasma glucose and renal function, except in patients who had significant UGE before treatment.","['T2DM patients with renal impairment', 'healthy subjects and patients with type 2 diabetes mellitus']",['ipragliflozin'],"['fasting plasma glucose and renal function', 'population mean oral clearance']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0297723,"The estimated individual maximum effect were dependent on fasting plasma glucose and renal function, except in patients who had significant UGE before treatment.","[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kaibara', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kadokura', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Kazuta', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Ueyama', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]",British journal of clinical pharmacology,['10.1111/bcp.13972']
2249,31176466,Effects of psychosocial stress on the hormonal and affective response in children with dyslexia.,"INTRODUCTION


Research on stress and dyslexia has mainly focused on chronic and contextual stress caused by the school environment. Our goal was to test individual differences in the hypothalamic-pituitary-adrenal (HPA) axis reactivity of dyslexic and non-dyslexic children and the related emotional manifestations associated with exposure to a psychosocial stressor.
METHODS


Eighty-one children (11-14 years old; 38 dyslexic) were exposed to the Trier Social Stress Test adapted to children or to a control condition. The salivary cortisol response, anxiety, and mood were measured before and after the stress.
RESULTS


Dyslexic children did not show the expected cortisol response, as the highest percentage of children who were non-reactive to stress was found in this group. Cortisol reactivity to stress was related to higher levels of anxiety and lower positive affect in the non-dyslexic children.
CONCLUSION


These results suggest a pattern of hypo-activation of the HPA axis to psychosocial stress in children with dyslexia.",2019,"Cortisol reactivity to stress was related to higher levels of anxiety and lower positive affect in the non-dyslexic children.
","['children with dyslexia', 'Eighty-one children (11-14 years old; 38 dyslexic']","['psychosocial stress', 'Trier Social Stress Test adapted to children or to a control condition']","['salivary cortisol response, anxiety, and mood', 'Cortisol reactivity', 'hypothalamic-pituitary-adrenal (HPA) axis reactivity of dyslexic', 'hormonal and affective response', 'cortisol response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}]",81.0,0.0101501,"Cortisol reactivity to stress was related to higher levels of anxiety and lower positive affect in the non-dyslexic children.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Espin', 'Affiliation': 'Department of Human Anatomy and Psychobiology, University of Murcia, 30100 Murcia, Spain; Laboratory of Social Cognitive Neuroscience, Department of Psychobiology, IDOCAL, University of Valencia, 46010 Valencia, Spain. Electronic address: lespin@um.es.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García', 'Affiliation': 'Department of Human Anatomy and Psychobiology, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Pino Sánchez', 'Affiliation': 'Department of Human Anatomy and Psychobiology, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Román', 'Affiliation': 'Department of Human Anatomy and Psychobiology, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Salvador', 'Affiliation': 'Laboratory of Social Cognitive Neuroscience, Department of Psychobiology, IDOCAL, University of Valencia, 46010 Valencia, Spain.'}]",Trends in neuroscience and education,['10.1016/j.tine.2019.03.001']
2250,31215111,Rivaroxaban pharmacodynamics in healthy volunteers evaluated with thrombin generation and the active protein C system: Modeling and assessing interindividual variability.,"BACKGROUND


Rivaroxaban is a direct factor Xa inhibitor with substantial inter-individual pharmacokinetic (PK) variability. Pharmacodynamic (PD) variability, especially assessed with thrombin generation (TG), has been less documented.
OBJECTIVES


(i) To assess TG parameter time profiles in healthy volunteers, with TG being studied under different conditions and (ii) to model the relationship between rivaroxaban concentrations and TG parameters and subsequently estimate interindividual variability.
METHODS


Sixty healthy male volunteers (DRIVING-NCT01627665) received a single 40-mg rivaroxaban dose. Blood sampling was performed at baseline and 10 predefined time points over 24 h. The TG was investigated with the fully automated ST-Genesia system (Stago), using two tissue-factor (TF) concentrations, in the absence (-), or presence (+) of thrombomodulin (TM) for the lowest one. The PD models were built to characterize the relationships between plasma rivaroxaban concentrations and endogenous thrombin potential (ETP) or peak height induced by the lowest TF concentration.
RESULTS


Thrombin generation parameter time profiles with the lowest TF concentration showed a good sensitivity to rivaroxaban, especially +TM (active protein C negative feedback). The relationship between rivaroxaban concentrations and TG parameters was modeled with a sigmoidal relation. Mean rivaroxaban concentrations halving the baseline value of ETP and peak height (-TM) (C 50  ) were of 284 and 33.2 ng/mL, respectively: +TM, C 50  declined to 19.4 and 13.8 ng/mL, reflecting a powerful inhibitory effect. The estimated C 50  population coefficients of variation were of 12.2% (-TM) and 31.3% (+TM) with the peak height models, 34.8% (+TM) with the ETP model.
CONCLUSIONS


This low-rivaroxaban to moderate-rivaroxaban PD variability in healthy volunteers contrasts with the substantial PK variability and deserves to be studied in different patient settings.",2019,"Mean rivaroxaban concentrations halving the baseline value of ETP and peak height (-TM) (C 50  ) were of 284 and 33.2 ng/mL, respectively: +TM, C 50  declined to 19.4 and 13.8 ng/mL, reflecting a powerful inhibitory effect.","['healthy volunteers', 'Sixty healthy male volunteers']","['thrombin generation (TG', 'rivaroxaban', 'Rivaroxaban', 'Rivaroxaban pharmacodynamics']","['plasma rivaroxaban concentrations and endogenous thrombin potential (ETP) or peak height', 'Pharmacodynamic (PD) variability', 'Mean rivaroxaban concentrations halving the baseline value of ETP and peak height (-TM', 'rivaroxaban concentrations and TG parameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",60.0,0.0466005,"Mean rivaroxaban concentrations halving the baseline value of ETP and peak height (-TM) (C 50  ) were of 284 and 33.2 ng/mL, respectively: +TM, C 50  declined to 19.4 and 13.8 ng/mL, reflecting a powerful inhibitory effect.","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Siguret', 'Affiliation': 'INSERM UMR_S1140, Paris, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Abdoul', 'Affiliation': 'INSERM UMR_S1140, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Delavenne', 'Affiliation': 'Laboratoire de Pharmacologie -Toxicologie, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Curis', 'Affiliation': 'Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Carlo', 'Affiliation': 'Diagnostica Stago, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Blanchard', 'Affiliation': 'Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Joe-Elie', 'Initials': 'JE', 'LastName': 'Salem', 'Affiliation': 'Département de Pharmacologie, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Gaussem', 'Affiliation': 'INSERM UMR_S1140, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Funck-Brentano', 'Affiliation': 'Département de Pharmacologie, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Azizi', 'Affiliation': 'Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'Service de Médecine Vasculaire et Thérapeutique, Centre Hospitalier Universitaire de Saint Étienne, Saint Étienne, France.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Loriot', 'Affiliation': 'Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lecompte', 'Affiliation': ""Unité d'Hémostase, Département de Médecine, Hôpitaux Universitaires de Genève (HUG) and GpG, Faculté de médecine, Université de Genève, Geneva, Switzerland.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gouin-Thibault', 'Affiliation': ""Laboratoire d'Hématologie Biologique, Centre Hospitalier Universitaire Pontchaillou, Rennes, France.""}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14541']
2251,31217353,Dietary carbohydrate restriction improves metabolic syndrome independent of weight loss.,"BACKGROUNDMetabolic syndrome (MetS) is highly correlated with obesity and cardiovascular risk, but the importance of dietary carbohydrate independent of weight loss in MetS treatment remains controversial. Here, we test the theory that dietary carbohydrate intolerance (i.e., the inability to process carbohydrate in a healthy manner) rather than obesity per se is a fundamental feature of MetS.METHODSIndividuals who were obese with a diagnosis of MetS were fed three 4-week weight-maintenance diets that were low, moderate, and high in carbohydrate. Protein was constant and fat was exchanged isocalorically for carbohydrate across all diets.RESULTSDespite maintaining body mass, low-carbohydrate (LC) intake enhanced fat oxidation and was more effective in reversing MetS, especially high triglycerides, low HDL-C, and the small LDL subclass phenotype. Carbohydrate restriction also improved abnormal fatty acid composition, an emerging MetS feature. Despite containing 2.5 times more saturated fat than the high-carbohydrate diet, an LC diet decreased plasma total saturated fat and palmitoleate and increased arachidonate.CONCLUSIONConsistent with the perspective that MetS is a pathologic state that manifests as dietary carbohydrate intolerance, these results show that compared with eucaloric high-carbohydrate intake, LC/high-fat diets benefit MetS independent of whole-body or fat mass.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT02918422.FUNDINGDairy Management Inc. and the Dutch Dairy Association.",2019,"Despite containing 2.5 times more saturated fat than the high-carbohydrate diet, an LC diet decreased plasma total saturated fat and palmitoleate and increased arachidonate.",[],['Dietary carbohydrate restriction'],"['abnormal fatty acid composition', 'metabolic syndrome independent of weight loss', 'plasma total saturated fat and palmitoleate and increased arachidonate']",[],"[{'cui': 'C0012170', 'cui_str': 'Carbohydrates, Dietary'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0135118', 'cui_str': 'palmitoleate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178485', 'cui_str': 'arachidonate'}]",,0.012523,"Despite containing 2.5 times more saturated fat than the high-carbohydrate diet, an LC diet decreased plasma total saturated fat and palmitoleate and increased arachidonate.","[{'ForeName': 'Parker N', 'Initials': 'PN', 'LastName': 'Hyde', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Teryn N', 'Initials': 'TN', 'LastName': 'Sapper', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Crabtree', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'LaFountain', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Madison L', 'Initials': 'ML', 'LastName': 'Bowling', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Buga', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Fionn T', 'Initials': 'FT', 'LastName': 'McSwiney', 'Affiliation': 'Department of Sport and Exercise Science, Waterford Institute of Technology, Waterford, Ireland.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Miller', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Scandling', 'Affiliation': 'Davis Heart & Lung Research Institute, Department of Radiology; Department of Internal Medicine, Division of Cardiovascular Medicine; Wexner Medical Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Orlando P', 'Initials': 'OP', 'LastName': 'Simonetti', 'Affiliation': 'Davis Heart & Lung Research Institute, Department of Radiology; Department of Internal Medicine, Division of Cardiovascular Medicine; Wexner Medical Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Phinney', 'Affiliation': 'Virta Health, San Francisco, California, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'King', 'Affiliation': ""Department of Atherosclerosis Research, Children's Hospital Oakland Research Institute, Oakland, California, USA.""}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Krauss', 'Affiliation': ""Department of Atherosclerosis Research, Children's Hospital Oakland Research Institute, Oakland, California, USA.""}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}]",JCI insight,['10.1172/jci.insight.128308']
2252,31226579,Capturing behavioral indicators of persecutory ideation using mobile technology.,"Most existing measures of persecutory ideation (PI) rely on infrequent in-person visits, and this limits their ability to assess rapid changes or real-world functioning. Mobile health (mHealth) technology may address these limitations. Little is known about passively sensed behavioral indicators associated with PI. In the current study, sixty-two participants with schizophrenia spectrum disorders completed momentary assessments of PI on a smartphone that also passively collected behavioral data for one year. Results suggested that PI was prevalent (n = 50, 82% of sample) but had infrequent incidence (25.2% of EMA responses). PI was also associated with changes in several passively sensed variables, including decreases in distance traveled (M kilometers  = -1.20, SD = 18.88), time spent in a vehicle (M minutes  = -4.15, SD = 49.59), length of outgoing phone calls (M minutes  = -0.79, SD = 13.13), time spent proximal to human speech (M minutes  = -6.26, SD = 153.03), and an increase in time sitting still (M minutes  = 4.04, SD = 94.69). The present study suggests changes associated with PI may be detectable by passive sensors, including reductions in moving or traveling, and time spent around others or in self-initiated phone conversations. These constructs might constitute risk for PI.",2019,"PI was also associated with changes in several passively sensed variables, including decreases in distance traveled (M kilometers  = -1.20, SD = 18.88), time spent in a vehicle (M minutes  = -4.15, SD = 49.59), length of outgoing phone calls (M minutes  = -0.79, SD = 13.13), time spent proximal to human speech (M minutes  = -6.26, SD = 153.03), and an increase in time sitting still (M minutes  = 4.04, SD = 94.69).",['sixty-two participants with schizophrenia spectrum disorders'],[],"['length of outgoing phone calls', 'time spent proximal to human speech', 'time spent', 'time sitting still']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]",62.0,0.0445838,"PI was also associated with changes in several passively sensed variables, including decreases in distance traveled (M kilometers  = -1.20, SD = 18.88), time spent in a vehicle (M minutes  = -4.15, SD = 49.59), length of outgoing phone calls (M minutes  = -0.79, SD = 13.13), time spent proximal to human speech (M minutes  = -6.26, SD = 153.03), and an increase in time sitting still (M minutes  = 4.04, SD = 94.69).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'Health Services Research & Development, Puget Sound VA Healthcare System, Seattle, WA, USA; Department of Health Services, School of Public Health, Univ. of Washington, Seattle, WA, USA; Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA. Electronic address: buckbe@uw.edu.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Scherer', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brian', 'Affiliation': 'Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Weichen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Tanzeem', 'Initials': 'T', 'LastName': 'Choudhury', 'Affiliation': 'Department of Information Science, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Hauser', 'Affiliation': 'The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Ben-Zeev', 'Affiliation': 'Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.06.002']
2253,31486004,Calibrating Local Population-Based Blood Pressure Data from NYC HANES 2013-2014.,"New York City Health and Nutrition Examination Survey (NYC HANES) was a population-based cross-sectional survey of NYC adults conducted twice, in 2004 and again in 2013-2014, to monitor the health of NYC adults 20 years or older. While blood pressure was measured in both surveys, an auscultatory mercury sphygmomanometer was used to measure blood pressure in clinics in 2004, and an oscillometric LifeSource UA-789AC monitor was used in homes in 2013-2014. To assess comparability of blood pressure results across both surveys, we undertook a randomized study comparing blood pressure (BP) readings by the two devices. Blood pressure measuring protocols followed the 2013 Association for the Advancement in Medical instrumentation guidelines for non-invasive blood pressure device. Data from 167 volunteers were analyzed for this purpose.Paired t tests were used to test for significant difference in mean systolic and diastolic blood pressure between devices for overall and by mid-arm circumference categories. To test for systematic differences between the two devices, we generated Bland-Altman graphs. Sensitivity, specificity, and Kappa statistics were calculated to assess between-device agreement for high (≥ 130/80 mmHg) and not high (< 130/80 mmHg) blood pressure, with mercury set as the reference.Systolic and diastolic blood pressure measured by LifeSource UA-789AC were on average 2.0 and 1.1 mmHg higher, respectively, than those of the mercury sphygmomanometer systolic and diastolic blood pressure readings (P < 0.05). Sensitivity was 81%, specificity was 96%, and the Kappa coefficient was 75%. The Bland-Altman graphs showed that the between-device difference did not vary as a function of the average of the two devices for systolic blood pressure and was larger in the lower and upper ends for diastolic blood pressure. Given the observed differences in systolic and diastolic blood pressure readings between the two blood pressure measurement approaches, we calibrated NYC HANES 2013-2014 blood pressure data by predicting mercury blood pressure values from LifeSource blood pressure values. The mean systolic and diastolic blood pressure in NYC HANES 2013-2014 were lower when data were calibrated.",2019,Paired t tests were used to test for significant difference in mean systolic and diastolic blood pressure between devices for overall and by mid-arm circumference categories.,"['167 volunteers', 'New York City Health and Nutrition Examination Survey (NYC HANES) was a population-based cross-sectional survey of NYC adults conducted twice, in 2004 and again in 2013-2014, to monitor the health of NYC adults 20\xa0years or older']",[],"['Sensitivity', 'blood pressure', 'mercury sphygmomanometer systolic and diastolic blood pressure readings', 'Systolic and diastolic blood pressure', 'blood pressure (BP) readings', 'mean systolic and diastolic blood pressure', 'Kappa coefficient', 'systolic blood pressure', 'systolic and diastolic blood pressure readings', 'Sensitivity, specificity, and Kappa statistics', 'diastolic blood pressure']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0183432', 'cui_str': 'Mercury sphygmomanometer'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",167.0,0.0346352,Paired t tests were used to test for significant difference in mean systolic and diastolic blood pressure between devices for overall and by mid-arm circumference categories.,"[{'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Kanchi', 'Affiliation': 'Department of Population Health, Division of Epidemiology, NYU Langone Health, New York, USA. rania.kanchi@nyumc.org.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Perlman', 'Affiliation': 'Division of Epidemiology, NYC Department of Health and Mental Hygiene, New York, USA.'}, {'ForeName': 'Yechiam', 'Initials': 'Y', 'LastName': 'Ostchega', 'Affiliation': 'Center for Disease Control and Prevention, National Center for Health Statistics, Hyattsville, USA.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Chamany', 'Affiliation': 'Division of Prevention and Primary Care, NYC Department of Health and Mental Hygiene, New York, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'The Columbia Hypertension Center, Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Chernov', 'Affiliation': 'Division of Epidemiology, NYC Department of Health and Mental Hygiene, New York, USA.'}, {'ForeName': 'Lorna E', 'Initials': 'LE', 'LastName': 'Thorpe', 'Affiliation': 'Department of Population Health, Division of Epidemiology, NYU Langone Health, New York, USA.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-019-00385-x']
2254,32841287,Binocular visual function after staged implantation of extended-depth-of-focus intraocular lens targeting emmetropia and -0.5 diopter: A prospective comparison.,"The prospective comparative case series aimed to evaluate the binocular uncorrected visual acuities (BUCVAs) after staged implantations of extended-depth-of-focus intraocular lenses (EDOF IOLs) targeting emmetropia and -0.5 diopter (D). Diffractive EDOF IOLs with an add power of +1.75 D were implanted in the first eyes targeting emmetropia or -0.5 D according to the patients' preferences, then the targets for the second eyes were determined 1 week or longer after the implantation. IOL powers were determined with the SRK/T formula. Consequently, the subjects were divided into 3 groups: those with emmetropia targeted bilaterally (group EE, 22 patients), those with -0.5 D targeted bilaterally (group MM, 21 patients), and those with monovision of emmetropia and -0.5 D (group EM, 21 patients). Manifest refraction spherical equivalent (MRSE), BUCVA from 0.3 to 5 meters, spectacle use, and questionnaire regarding photic symptoms and patient satisfaction were assessed 3 months postoperatively. No significant differences were seen in the mean BUCVAs at any distance (P > 0.23), spectacle use (P = 0.13), or photic symptoms and patient satisfaction (P>0.65). When the EE and MM groups were assigned based on the MRSE, the EE group was better at 5 m (P = 0.005) while the MM group at 0.5 m (P = 0.031). The effect of different targeted refractions was not identified due to insufficient accuracy in the use of the SRK/T power calculation.",2020,"No significant differences were seen in the mean BUCVAs at any distance (P > 0.23), spectacle use (P = 0.13), or photic symptoms and patient satisfaction (P>0.65).",[],"['extended-depth-of-focus intraocular lens targeting emmetropia and -0.5 diopter', 'extended-depth-of-focus intraocular lenses (EDOF IOLs']","['mean BUCVAs', 'photic symptoms and patient satisfaction', 'Binocular visual function', 'IOL powers', 'Manifest refraction spherical equivalent (MRSE), BUCVA from 0.3 to 5 meters, spectacle use, and questionnaire regarding photic symptoms and patient satisfaction', 'binocular uncorrected visual acuities (BUCVAs']",[],"[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",22.0,0.019775,"No significant differences were seen in the mean BUCVAs at any distance (P > 0.23), spectacle use (P = 0.13), or photic symptoms and patient satisfaction (P>0.65).","[{'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Ota', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bissen-Miyajima', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Hirasawa', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Minami', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0238135']
2255,32841300,"An age-adapted plyometric exercise program improves dynamic strength, jump performance and functional capacity in older men either similarly or more than traditional resistance training.","Power declines at a greater rate during ageing and is more relevant for functional deterioration than either loss of maximum strength or muscle mass. Human movement typically consists of stretch-shortening cycle action. Therefore, plyometric exercises, using an eccentric phase quickly followed by a concentric phase to optimize power production, should resemble daily function more than traditional resistance training, which primarily builds force production capacity in general. However, it is unclear whether older adults can sustain such high-impact training. This study compared the effects of plyometric exercise (PLYO) on power, force production, jump and functional performance to traditional resistance training (RT) and walking (WALK) in older men. Importantly, feasibility was investigated. Forty men (69.5 ± 3.9 years) were randomized to 12-weeks of PLYO (N = 14), RT (N = 12) or WALK (N = 14). Leg press one-repetition maximum (1-RM), leg-extensor isometric maximum voluntary contraction (MVC) and rate of force development (RFD), jump and functional performance were evaluated pre- and post-intervention. One subject in RT (low back pain) and three in PLYO (2 muscle strains, 1 knee pain) dropped out. Adherence to (91.2 ± 4.4%) and acceptability of (≥ 7/10) PLYO was high. 1-RM improved more in RT (25.0 ± 10.0%) and PLYO (23.0 ± 13.6%) than in WALK (2.9 ± 13.7%) (p < 0.001). PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK and/or RT (p < 0.05). MVC improved in RT only (p = 0.028) and RFD did not improve (p > 0.05). To conclude, PLYO is beneficial over RT for improving power, jump and stair climbing performance without compromising gains in strength. This form of training seems feasible, but contains an inherent higher risk for injuries, which should be taken into account when designing programs for older adults.",2020,"PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK","['older adults', 'Forty men (69.5 ± 3.9 years', 'older men', 'older men either similarly or more than traditional resistance training']","['PLYO', 'plyometric exercise program', 'plyometric exercises', 'WALK', 'traditional resistance training (RT) and walking (WALK', 'plyometric exercise (PLYO']","['dynamic strength, jump performance and functional capacity', 'RFD', 'power, force production, jump and functional performance', 'jump height, jump power, contraction time of jumps and stair climbing performance', 'Leg press one-repetition maximum (1-RM), leg-extensor isometric maximum voluntary contraction (MVC) and rate of force development (RFD), jump and functional performance', 'MVC improved in RT', '1-RM improved more in RT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",40.0,0.0188582,"PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK","[{'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Van Roie', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Van Driessche', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Tijs', 'Initials': 'T', 'LastName': 'Delabastita', 'Affiliation': 'Human Movement Biomechanics Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Vanwanseele', 'Affiliation': 'Human Movement Biomechanics Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Delecluse', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]",PloS one,['10.1371/journal.pone.0237921']
2256,32841325,Personalized Yoga Therapy for Multiple Sclerosis: Effect on Symptom Management and Quality of Life.,"This study aimed to assess the feasibility of personalized yoga therapy intervention in a private setting and its effect on quality of life (QOL), sleep quality, and symptom relief among patients with multiple sclerosis (MS). A single-group pre- and post-experimental study was conducted among 10 members of the Multiple Sclerosis Society of India between December 2017 and April 2018. At baseline and during follow-up, QOL, sleep quality, symptoms, and pain were assessed using the Multiple Sclerosis Quality of Life, Pittsburgh Sleep Quality Index, MS Symptom Checklist, and visual analogue scale, respectively. The intervention comprised 12 private customized yoga sessions of 1 hour duration and three group sessions, all spread over 3-months. Patient feedback and direct observations by the yoga therapist we re documented at each session. Ten patients (seven female, three male, age 31-52 years) were enrolled in the yoga intervention; seven completed 8-12 sessions, and three completed fewer than 5 sessions. Therapist-to-patient ratio was 1:2. All domains except sexual function showed clinically significant improvement in QOL scores. Statistically significant improvement was found in social function (p = 0.014) and change in health status (p = 0.029) scores after the intervention. Although there was improvement in pain and sleep quality, these changes were not statistically significant. Patients reported improvement in symptoms with practice of yoga alongside lifestyle changes. The study supports the feasibility of this 3-month yoga intervention for patients with MS. Studies with larger sample sizes are required to confirm our findings.",2020,Statistically significant improvement was found in social function (p = 0.014) and change in health status (p = 0.029) scores after the intervention.,"['patients with multiple sclerosis (MS', 'Multiple Sclerosis', '10 members of the Multiple Sclerosis Society of India between December 2017 and April 2018', 'patients with MS', 'Ten patients (seven female, three male, age 31-52 years']","['Personalized Yoga Therapy', 'yoga intervention', 'personalized yoga therapy intervention', 'yoga therapist']","['quality of life (QOL), sleep quality, and symptom relief', 'Multiple Sclerosis Quality of Life, Pittsburgh Sleep Quality Index, MS Symptom Checklist, and visual analogue scale', 'change in health status', 'Symptom Management and Quality of Life', 'QOL, sleep quality, symptoms, and pain', 'QOL scores', 'social function', 'pain and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0189652,Statistically significant improvement was found in social function (p = 0.014) and change in health status (p = 0.029) scores after the intervention.,"[{'ForeName': 'Saraswathi', 'Initials': 'S', 'LastName': 'Vasudevan', 'Affiliation': 'Yogavahini Foundation, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Shakuntala', 'Initials': 'S', 'LastName': 'Devulapally', 'Affiliation': 'Yogavahini Foundation, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Kamala', 'Initials': 'K', 'LastName': 'Chirravuri', 'Affiliation': 'Yogavahini Foundation, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Vidhubala', 'Initials': 'V', 'LastName': 'Elangovan', 'Affiliation': 'Fenivi Research Solutions, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Niraimathi', 'Initials': 'N', 'LastName': 'Kesavan', 'Affiliation': 'Fenivi Research Solutions, Chennai, Tamil Nadu, India.'}]",International journal of yoga therapy,['10.17761/2021-D-19-00037']
2257,32841376,"Intraoperative ultrasound versus fluorescence and X-ray cholangiography for the identification of bile duct stones, biliary anatomy and bile duct injury during laparoscopic cholecystectomy: Time for a randomized controlled trial?",,2020,,[],"['laparoscopic cholecystectomy', 'Intraoperative ultrasound versus fluorescence and X-ray cholangiography']",[],[],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C2368278', 'cui_str': 'Intraoperative ultrasonography'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0008307', 'cui_str': 'Cholangiogram'}]",[],,0.09645,,"[{'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Labib', 'Affiliation': 'Department of hepatopancreaticobiliary (HPB) surgery, Derriford Hospital, Derriford road, Plymouth, PL4 6PU.'}, {'ForeName': 'Somaiah', 'Initials': 'S', 'LastName': 'Aroori', 'Affiliation': 'Department of hepatopancreaticobiliary (HPB) surgery, Derriford Hospital, Derriford road, Plymouth, PL4 6PU.'}]",The British journal of surgery,['10.1002/bjs.11862']
2258,32841412,Preliminary clinical evaluation of traditional and a new digital PEEK occlusal splints for the management of sleep bruxism.,"OBJECTIVE


To compare the manual time and preliminary clinical effects between the digital manufactured occlusal splints for sleep bruxism patients with those of traditional hard splints.
METHODS


Sixteen individuals (18 to 44 y/o) with clinically diagnosed sleep bruxism were selected based on the inclusion criteria. All patients were divided to two groups and a random control method was applied. Digital splints (test group) were designed and milled using CAD/CAM. Hard splints (control group) were made of transparent acrylic resin in laboratory office. The manual time spent including impression obtaining, splint production and clinical occlusal adjustment was recorded. A visual analog scale was used to report the subjective evaluations. The maximum depth loss and volumetric loss of the occlusal surface of splints in posterior tooth were measured. SPSS software was used for statistical analysis (p = 0.05).
RESULTS


Comparing with control group, the manual time spent in test group was significantly less in all of three procedures, (p < 0.001). The VAS scores for retention were not significantly different (p = 0.086) but the wearing comfort scores of test group were significantly higher (p < 0.001). Both maximum depth loss (p = 0.007) and volumetric loss in test group were significantly less than control group (p = 0.005).
CONCLUSION


In the current study, the digitally manufactured splints exhibit significantly improved comfort and time-efficiency than traditional hard splints. Moreover, the new milling material (PEEK) has better wear resistance than acrylic resins.",2020,"Both maximum depth loss (p = 0.007) and volumetric loss in test group were significantly less than control group (p = 0.005).
","['Sixteen individuals (18 to 44 y/o) with clinically diagnosed sleep bruxism were selected based on the inclusion criteria', 'sleep bruxism patients with those of traditional hard splints']","['transparent acrylic resin', 'Digital splints', 'digital manufactured occlusal splints', 'new milling material (PEEK']","['manual time spent including impression obtaining, splint production and clinical occlusal adjustment', 'maximum depth loss and volumetric loss of the occlusal surface of splints in posterior tooth', 'VAS scores for retention', 'comfort and time-efficiency', 'volumetric loss', 'manual time spent', 'wearing comfort scores']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0341000', 'cui_str': 'Occlusal adjustment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.023296,"Both maximum depth loss (p = 0.007) and volumetric loss in test group were significantly less than control group (p = 0.005).
","[{'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing, PR China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing, PR China.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Associate Clinical Professor, Department of Prosthodontics, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Associate Clinical Professor, Department of Implantology, Yinchuan Stomatology Hospital, Yinchuan, Ningxia Province, 750002, PR China.'}, {'ForeName': 'Yunsong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}]",Journal of oral rehabilitation,['10.1111/joor.13083']
2259,32841433,"French maritime pine bark extract (pycnogenol) in association with triple combination cream for the treatment of facial melasma in women: a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Melasma can be recalcitrant to treatment, and relapses are common. Pycnogenol has been reported to be effective in treating melasma.
OBJECTIVE


To compare the efficacy, safety, and tolerability of 75 mg pycnogenol taken orally twice a day versus a placebo, in association with the triple combination and broad-spectrum sunscreen for the treatment of facial melasma.
METHODS


A randomized, double-blind, parallel, placebo-controlled study was conducted on 44 women with facial melasma in a single centre from May 2019 through November 2019. Patients with melasma were randomly assigned to orally take 75 mg pycnogenol (PYC) or a placebo (PLAC) twice a day for 60 days. Both groups also received tinted sunscreen (SPF 50; PPD 17) for daytime use and a topical triple combination at bedtime. The primary outcome was a change from the baseline mMASI score. Secondary outcomes were improvements in the patients' quality of life (MELASQoL), colorimetric indices, and Global Aesthetic Improvement Scale (GAIS).
RESULTS


All participants completed the trial. The mean (SD) age of the participants was 39 (7) years, and 91% were phototypes III-IV. Both groups exhibited a reduction in mMASI scores, MELASQoL scores, and colour contrast (p<0.01). The mean (CI 95%) reductions of the mMASI scores were 49% (36-61%) for PYC and 34% (16-47%) for PLAC. The reductions in mMASI scores and colorimetric contrast were superior for the PYC group (p<0.05). The analysis of GAIS resulted in an improvement of 86% (CI 95% 68-96%) for the participants in the PYC group and 55% (CI 95% 32-73%) for those in the PLAC group. There were no adverse effects related to oral treatment.
CONCLUSION


Pycnogenol is well-tolerated and increases the effectiveness of broad-spectrum sunscreen and the triple combination in the treatment of facial melasma in women.",2020,The reductions in mMASI scores and colorimetric contrast were superior for the PYC group (p<0.05).,"['Patients with melasma', '44 women with facial melasma in a single centre from May 2019 through November 2019', 'facial melasma in women']","['triple combination and broad-spectrum sunscreen', 'pycnogenol (PYC) or a placebo (PLAC', 'triple combination cream', 'tinted sunscreen', 'placebo', 'French maritime pine bark extract (pycnogenol']","['efficacy, safety, and tolerability', 'mMASI scores, MELASQoL scores, and colour contrast (p<0.01', 'adverse effects', 'change from the baseline mMASI score', 'mMASI scores', ""patients' quality of life (MELASQoL), colorimetric indices, and Global Aesthetic Improvement Scale (GAIS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0072642', 'cui_str': 'Pycnogenol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C4283948', 'cui_str': 'French maritime pine bark extract'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",44.0,0.628173,The reductions in mMASI scores and colorimetric contrast were superior for the PYC group (p<0.05).,"[{'ForeName': 'Paula Basso', 'Initials': 'PB', 'LastName': 'Lima', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Alexandria Ferreira Dias', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Ana Cláudia Cavalcante', 'Initials': 'ACC', 'LastName': 'Esposito', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Luciane Donida Bartoli', 'Initials': 'LDB', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, UNESP, Botucatu, SP, Brazil.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, UNESP, Botucatu, SP, Brazil.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16896']
2260,32841462,Evaluating functional disability in clinical trials of lisdexamfetamine dimesylate in binge eating disorder using the Sheehan Disability Scale.,"OBJECTIVES


This study examined Sheehan Disability Scale (SDS) performance in binge eating disorder (BED) and explored relationships between SDS and BED outcomes using data from three placebo-controlled lisdexamfetamine (LDX) studies (two short-term, dose-optimized studies and one double-blind, randomized-withdrawal study) in adults with Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR)-defined BED.
METHODS


Analyses evaluated the psychometric properties of the SDS.
RESULTS


Confirmatory factor analysis supported a unidimensional total score in the short-term studies, with internal consistency (Cronbach's α) being 0.878. Total score exhibited good construct validity, with moderate and statistically significant correlations observed with Yale-Brown Obsessive Compulsive Scale modified for binge eating, Binge Eating Scale (BES), and EuroQol Group 5-Dimension 5-Level health status index scores. Known-groups validity analysis for the short-term studies demonstrated a significantly lower total score at end of study in participants considered ""not ill"" versus ""ill"" based on Clinical Global Impressions-Severity scores. SDS total score changes in the short-term studies were greater in responders than nonresponders based on binge eating abstinence or BES score. In the randomized-withdrawal study, SDS scores increased relative to baseline to a greater extent in participants randomized to placebo than LDX.
CONCLUSIONS


These analyses support the reliability, validity, and responsiveness to change of the SDS in individuals with BED.",2020,SDS total score changes in the short-term studies were greater in responders than nonresponders based on binge eating abstinence or BES score.,"['binge eating disorder (BED', 'individuals with BED', 'adults with Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR)-defined BED']","['lisdexamfetamine dimesylate', 'placebo-controlled lisdexamfetamine (LDX', 'placebo']","['total score', 'SDS total score changes', 'Sheehan Disability Scale (SDS) performance', 'Sheehan Disability Scale', 'SDS scores', 'unidimensional total score', 'Yale-Brown Obsessive Compulsive Scale modified for binge eating, Binge Eating Scale (BES), and EuroQol Group 5-Dimension 5-Level health status index scores', 'binge eating abstinence or BES score']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C1739826', 'cui_str': 'Lisdexamfetamine dimesylate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0018761', 'cui_str': 'Health status index'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.0619976,SDS total score changes in the short-term studies were greater in responders than nonresponders based on binge eating abstinence or BES score.,"[{'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Yee', 'Affiliation': 'Shire, a Member of the Takeda Group of Companies, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Pokrzywinski', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, Maryland, USA.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Hareendran', 'Affiliation': 'Patient-Centered Research, Evidera, London, UK.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Shaffer', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, Maryland, USA.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Sheehan', 'Affiliation': 'University of South Florida College of Medicine, Tampa, Florida, USA.'}]",International journal of methods in psychiatric research,['10.1002/mpr.1849']
2261,32841523,Intensive Weight Loss Intervention and Cancer Risk in Adults with Type 2 Diabetes: Analysis of the Look AHEAD Randomized Clinical Trial.,"OBJECTIVE


This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality.
METHODS


Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer.
RESULTS


After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25).
CONCLUSIONS


An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.",2020,"There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25).
","['Adults with Type 2 Diabetes', '684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer', 'adults with overweight or obesity and type 2 diabetes', '4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer']","['Intensive Weight Loss Intervention', 'intensive lifestyle intervention (ILI']","['total cancer mortality', 'incidence of nonobesity-related cancers', 'incidence rates of obesity-related cancers', 'overall cancer incidence, obesity-related cancer incidence, and cancer mortality', 'total cancer incidence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",4859.0,0.156537,"There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Departments of Medicine, Epidemiology, and Oncology, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bantle', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cassidy-Begay', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix Epidemiology and Clinical Research Branch, Phoenix, Arizona, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Byers', 'Affiliation': 'Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Egan', 'Affiliation': 'Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Garcia', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Goldman', 'Affiliation': 'Diabetes Clinical Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Imperial College London, London, UK.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hesson', 'Affiliation': 'Center for Weight and Eating Disorders, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Department of Medicine, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System / University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix Epidemiology and Clinical Research Branch, Phoenix, Arizona, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Korytkowski', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System / University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Mantzoros', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meacham', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix Epidemiology and Clinical Research Branch, Phoenix, Arizona, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Department of Medicine, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Diabetes Clinical Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Division of Cardiology, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Safford', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sedjo', 'Affiliation': 'Department of Community and Behavioral Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinburg', 'Affiliation': 'Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Department of Oncology, The Johns Hopkins Sydney Kimmel Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22936']
2262,32841525,"Antiobesity effect of Gynostemma pentaphyllum Extract (Actiponin): A Randomized, Double-Blind, Placebo-Controlled Trial.",,2020,,[],"['Gynostemma pentaphyllum Extract (Actiponin', 'Placebo']",[],[],"[{'cui': 'C0950016', 'cui_str': 'Gynostemma pentaphyllum'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3886709', 'cui_str': 'actiponin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.725478,,[],"Obesity (Silver Spring, Md.)",['10.1002/oby.22991']
2263,32841543,"Comparison between the effects of elective nodal irradiation and involved-field irradiation on long-term survival in thoracic esophageal squamous cell carcinoma patients: A prospective, multicenter, randomized, controlled study in China.","BACKGROUND


This study's initial results revealed significant decreases in treatment-related esophagitis and pneumonitis cases in patients with thoracic esophageal squamous cell carcinoma (ESCC) treated with involved-field irradiation (IFI), compared to elective nodal irradiation (ENI). This report outlines the long-term trial results, specifically; overall survival (OS), progression-free survival (PFS), metastasis-free survival (MFS), and locoregional progression-free survival (LRFS).
MATERIALS AND METHODS


Stage II-III thoracic ESCC patients were assigned randomly, in a 1:1 ratio, into either the ENI or IFI arm. Radiation therapy was delivered once a day in 1.8-2.0 Gy fractions to a total dose of 60.0-66.0 Gy to the gross tumor volume and 50.0-54.0 Gy to the clinical target volume. The primary endpoints were acute treatment-related esophagitis and pneumonitis. The results for the primary endpoints were previously published in 2018. In this article, we analyzed the secondary endpoints including PFS, LRFS, MFS, and OS.
RESULTS


Between April 2012 and October 2016, 228 patients from nine participating centers in China were enrolled into this study and randomly assigned to two treatment groups. For ENI and IFI groups, respectively, the results showed similarity and were as follows: median PFS (20.3 months vs 21.4 months), OS (32.5 months vs 34.9 months), MFS (28.2 months vs 26.0 months), and LRFS (25.0 months vs 26.6 months). In particular, respective OS rates in the ENI and IFI groups were 84.6% and 82.5% after 1 year, 45.1% and 48.7% after 3 years, and 29.8% and 30.7% at 5 years. PFS rates after 1, 3, and 5 years were 58.9%, 34.2%, and 26.9%, respectively, in the ENI arm compared to 64.4%, 30.8%, and 27.7%, respectively, in the IFI arm. Multivariate analysis identified clinical stage and tumor responses as independent predictors of OS. Meanwhile, tumor location, cStage, and tumor response were identified as independent factors influencing PFS.
CONCLUSION


IFI was associated with similar survival as ENI in patients with thoracic ESCC, suggesting that IFI is an acceptable treatment method for thoracic ESCC.",2020,"PFS rates after 1, 3, and 5 years were 58.9%, 34.2%, and 26.9%, respectively, in the ENI arm compared to 64.4%, 30.8%, and 27.7%, respectively, in the IFI arm.","['patients with thoracic esophageal squamous cell carcinoma (ESCC', 'thoracic ESCC patients', 'Stage II-III', '228 patients from nine participating centers in China', 'Between April 2012 and October 2016', 'thoracic esophageal squamous cell carcinoma patients', 'patients with thoracic ESCC']","['elective nodal irradiation (ENI', 'Radiation therapy', 'elective nodal irradiation and involved-field irradiation']","['PFS rates', 'acute treatment-related esophagitis and pneumonitis', 'respective OS rates', 'PFS, LRFS, MFS, and OS', 'overall survival (OS), progression-free survival (PFS), metastasis-free survival (MFS), and locoregional progression-free survival (LRFS', 'LRFS', 'MFS', 'Meanwhile, tumor location, cStage, and tumor response', 'OS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0547264,"PFS rates after 1, 3, and 5 years were 58.9%, 34.2%, and 26.9%, respectively, in the ENI arm compared to 64.4%, 30.8%, and 27.7%, respectively, in the IFI arm.","[{'ForeName': 'Jiahua', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Abulimiti', 'Initials': 'A', 'LastName': 'Yisikandaer', 'Affiliation': 'The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xiaozhi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xiaohu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Gansu Cancer Hospital, Lanzhou, China.'}, {'ForeName': 'Zhongge', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'Wu Wei Tumor Hospital, Wu Wei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'The Affiliated Cancer Hospital of Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Guizhou Cancer Hospital, Guiyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Kunming General Hospital of Chengdu Military Region, Kunming, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Xinjiang Renmin Hospital, Xinjiang, China.'}, {'ForeName': 'Qifeng', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Jinnrong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Youguo', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Wu Wei Tumor Hospital, Wu Wei, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Gansu Cancer Hospital, Lanzhou, China.'}, {'ForeName': 'Aiguri', 'Initials': 'A', 'LastName': 'Hage', 'Affiliation': 'The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}]",Cancer medicine,['10.1002/cam4.3409']
2264,32841554,Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study.,"OBJECTIVE


To describe the long-term safety, tolerability, and symptom trajectory with the long-acting injectable antipsychotic aripiprazole lauroxil (AL) in patients with DSM-5-diagnosed schizophrenia followed for up to 180 weeks (3.5 years).
METHODS


Long-term safety of 2 fixed doses of AL (441 or 882 mg every 4 weeks) was assessed during up to 180 weeks (3.5 years) of continuous AL exposure using data from 2 sequential long-term safety studies. Safety metrics included adverse events (AEs), AEs leading to study discontinuations, physical examinations, laboratory parameters, and extrapyramidal symptom (EPS) rating scales. Symptom trajectory was assessed in post hoc analyses using Positive and Negative Syndrome Scale total (PANSST) and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores.
RESULTS


A total of 478 patients entered the 52-week study and were included in the safety analysis. After the first 52 weeks, safety assessments revealed no new safety concerns and were consistent with the known safety profile of aripiprazole. AEs were reported by 57.5% of patients (441 mg, 52.7%; 882 mg, 59.0%). EPS-related AEs occurred in 12.8% of patients (441 mg, 9.1%; 882 mg, 13.9%). In the post hoc analysis (n = 432), least-squares mean (SE) PANSST scores improved significantly from weeks 12 to 124 with AL 441 mg (-5.5 [0.9]) and 882 mg (-5.0 [0.5]; both P < .0001). CGI-S scores followed a similar pattern of improvement.
CONCLUSIONS


The AL safety profile over 180 weeks (3.5 years) of follow-up was consistent with prior 52-week results. Continued therapeutic efficacy, based on PANSST and CGI-S scores, was observed throughout the post hoc analysis period.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01626456; ClinicalTrials.gov identifier: NCT01895452.",2020,"Continued therapeutic efficacy, based on PANSST and CGI-S scores, was observed throughout the post hoc analysis period.
","['Patients With Schizophrenia Continuing in an Extension Study', '478 patients entered the 52-week study and were included in the safety analysis', 'patients with DSM-5-diagnosed schizophrenia followed for up to 180 weeks (3.5 years']","['long-acting injectable antipsychotic aripiprazole lauroxil (AL', 'Aripiprazole Lauroxil', 'AL', 'aripiprazole']","['Positive and Negative Syndrome Scale total (PANSST) and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores', 'adverse events (AEs), AEs leading to study discontinuations, physical examinations, laboratory parameters, and extrapyramidal symptom (EPS) rating scales', 'EPS-related AEs', 'least-squares mean (SE) PANSST scores', 'PANSST and CGI-S scores', 'CGI-S scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}]",478.0,0.0739064,"Continued therapeutic efficacy, based on PANSST and CGI-S scores, was observed throughout the post hoc analysis period.
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lauriello', 'Affiliation': 'Department of Psychiatry and Human Behavior, Thomas Jefferson University, 833 Chestnut St, Ste 210, Philadelphia, PA 19107. john.lauriello@jefferson.edu.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Claxton', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12835']
2265,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
2266,32841892,Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide.,"This study used a novel theory-informed latent class approach, based on the Interpersonal Psychological Theory of Suicide (IPTS), to identify subgroups of individuals with a suicide attempt history. The identification of subgroups can inform treatments that target these specific subgroups. Using data from a randomised controlled trial, latent class analysis was conducted on 227 adults with a suicide attempt history. Latent classes were identified based on suicide attempt history, perceived burdensomeness, thwarted belongingness, and capability for suicide at the trial baseline. Three classes were found. Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants). Class 1 had elevated suicidal ideation for the duration of the trial. Classes 1 and 2 also had elevated interpersonal risks relative to a population-based sample. These results suggest that some individuals with a suicide attempt history exhibit relatively low interpersonal risks, and given concurrent protective psychological factors, may be suited to low-intensity interventions. At the other extreme, some individuals with a suicide attempt history require high-intensity interventions addressing interpersonal risks, clinical symptoms, and protective psychological factors.",2020,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","['individuals with a suicide attempt history', 'Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide', '227 adults with a suicide attempt history']",[],"['elevated suicidal ideation', 'interpersonal risks and clinical symptoms, and lower protective psychological factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033906', 'cui_str': 'Psychological Theories'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}]",227.0,0.0482775,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","[{'ForeName': 'Quincy J J', 'Initials': 'QJJ', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia; School of Psychology, Western Sydney University, Sydney, NSW, Australia. Electronic address: q.wong@westernsydney.edu.au.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Bregje A J', 'Initials': 'BAJ', 'LastName': 'van Spijker', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}]",Psychiatry research,['10.1016/j.psychres.2020.113406']
2267,32841904,Hyperarousal symptoms and perceived burdensomeness interact to predict suicidal ideation among trauma-exposed individuals.,"The association between posttraumatic stress disorder (PTSD) and suicidal ideation is well-established and recent prospective studies have demonstrated the unique role of hyperarousal symptoms. In particular, over-arousal may elevate suicide risk in the presence of interpersonal vulnerability factors including thwarted belongingness, perceived burdensomeness, and acquired capability. Therefore, the current study sought to examine the differential associations between PTSD symptom clusters and suicidality and the impact of interpersonal risk factors. Trauma-exposed adults (N = 247) completed a questionnaire battery at baseline and three-month follow-up, as part of a larger randomized controlled trial of computerized interventions for suicide risk. Given the focus of the current study, treatment condition was controlled for in all analyses. Results indicated that hyperarousal symptoms significantly predict suicidality, while reexperiencing and avoidance symptoms do not. Specifically, greater hyperarousal symptoms predicted increased suicidal ideation among individuals with high perceived burdensomeness. Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability. Taken together, findings suggest that assessment of hyperarousal symptoms and perceived burdensomeness may serve to identify trauma-exposed individuals at greater risk for suicide. Additionally, these factors may serve as effective intervention targets.",2020,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.",['Trauma-exposed adults (N\xa0=\xa0247) completed a'],['questionnaire battery at baseline and three-month follow-up'],"['hyperarousal symptoms', 'suicidal ideation', 'Hyperarousal symptoms']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",247.0,0.0289762,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Morabito', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA. Electronic address: Morabito@psy.fsu.edu.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Boffa', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Carter E', 'Initials': 'CE', 'LastName': 'Bedford', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Jimmy P', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'Furman University, 3300 Poinsett Hwy, Greenville, SC, USA, 29613.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.029']
2268,32841937,Elimination of Benign Ventricular Premature Beats or Ventricular Tachycardia with Catheter Ablation versus Two Different Optimal Antiarrhythmic Drug Treatment Regimens (Sotalol or Verapamil/Flecainide).,"BACKGROUND


Symptomatic idiopathic ventricular arrhythmias (VA), including premature beats (VPB) and nonsustained ventricular tachycardia (VT) are commonly encountered arrhythmias. Although these VA are usually benign, their treatment can be a challenge to primary and secondary health care providers. Mainstay treatment is comprised of antiarrhythmic drugs (AAD) and, in case of drug intolerance or failure, patients are referred for catheter ablation to tertiary health care centers. These patients require extensive medical attention and drug regimens usually have disappointing results. A direct comparison between the efficacy of the most potent AAD and primary catheter ablation in these patients is lacking. The ECTOPIA trial will evaluate the efficacy of 2 pharmacological strategies and 1 interventional approach to: suppress the VA burden, improve the quality of life (QoL), and safety.
HYPOTHESIS


We hypothesize that flecainide/verapamil combination and catheter ablation are both superior to sotalol in suppressing VA in patients with symptomatic idiopathic VA.
STUDY DESIGN


The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil. One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden ≥5% on 24-h ambulatory rhythm monitoring will be included. Patients will be randomized in a 1:1:1 fashion. The primary endpoint is defined as >80% reduction of the VA burden on 24-h ambulatory Holter monitoring. After reaching the primary endpoint, patients randomized to one of the 2 AAD arms will undergo a cross-over to the other AAD treatment arm to explore differences in drug efficacy and QoL in individual patients. Due to the use of different AAD (with and without β-blocking characteristics) we will be able to explore the influence of alterations in sympathetic tone on VA burden reduction in different subgroups. Finally, this study will assess the safety of treatment with 2 different AAD and ablation of VA.",2020,"The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil.","['patients with symptomatic idiopathic VA', 'One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden']","['flecainide/verapamil combination and catheter ablation', 'primary catheter ablation', 'catheter ablation', 'Ventricular Tachycardia with Catheter Ablation versus Two Different Optimal Antiarrhythmic Drug Treatment Regimens (Sotalol or Verapamil/Flecainide', 'sotalol', 'sotalol or flecainide/verapamil', 'AAD (with and without β-blocking characteristics']","['quality of life (QoL), and safety', 'drug efficacy and QoL', 'VA burden on 24-h ambulatory Holter monitoring', '24-h ambulatory rhythm monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0016229', 'cui_str': 'Flecainide'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0037707', 'cui_str': 'Sotalol'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",180.0,0.056817,"The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Haanschoten', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Vernooy', 'Affiliation': 'Maastricht UMC+, Maastricht, The Netherlands.'}, {'ForeName': 'Rypko J', 'Initials': 'RJ', 'LastName': 'Beukema', 'Affiliation': 'Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Szili-Torok', 'Affiliation': 'Erasmus UMC, Rotterdam, The Netherlands.'}, {'ForeName': 'Rachel M A', 'Initials': 'RMA', 'LastName': 'Ter Bekke', 'Affiliation': 'Maastricht UMC+, Maastricht, The Netherlands.'}, {'ForeName': 'Muchtiar', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Jonas S S G', 'Initials': 'JSSG', 'LastName': 'de Jong', 'Affiliation': 'OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Otten', 'Affiliation': 'Gelre Ziekenhuizen, Apeldoorn, The Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Adiyaman', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Jaap Jan J', 'Initials': 'JJJ', 'LastName': 'Smit', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Peter Paul H M', 'Initials': 'PPHM', 'LastName': 'Delnoy', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Anand R', 'Initials': 'AR', 'LastName': 'Ramdat Misier', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands, a.elvan@isala.nl.'}]",Cardiology,['10.1159/000509661']
2269,32841968,Placebo Response Reduction and Accurate Pain Reporting Training Reduces Placebo Responses in a Clinical Trial on Chronic Low Back Pain: Results from a Comparison to the Literature.,"OBJECTIVE


A literature review was conducted to compare placebo responses in a recent trial-which implemented an Accurate Pain Reporting (APR) and Placebo Response Reduction (PRR) training program-to placebo responses in similar previous trials in chronic lower back pain (CLBP) which did not use such training.
METHODS


A literature search was performed to find parallel design, randomized, controlled trials of pharmacological treatments administered orally or via intravenous injection for CLBP. Studies were assessed for proportion of placebo responders, defined as the proportion of patients in the placebo group with ≥30% reduction in pain intensity. A chi square analysis was performed on the proportion of responders from the SPRINT trial and from other similar studies.
RESULTS


Of 844 studies identified in the initial screening process, 16 studies were included for comparison. The percentage of placebo responders was statistically significantly lower in the SPRINT study (19.1%) compared with other CLBP trials (38.0%) (P=0.003). Our results show that the placebo response was lower in the SPRINT trial than other comparable studies on CLBP.
DISCUSSION


These findings are consistent with results from other studies showing that neutralizing subject and study staff expectations of therapeutic benefit can decrease the placebo response in clinical trials. The results of this study suggest training subjects and staff to improve pain reporting accuracy, neutralize expectations, and decrease external cues that may bias subjects' pain ratings in clinical trials may effectively decrease the placebo response leading to increased assay sensitivity.",2020,The percentage of placebo responders was statistically significantly lower in the SPRINT study (19.1%) compared with other CLBP trials (38.0%) (P=0.003).,"['Of 844 studies identified in the initial screening process', 'chronic lower back pain (CLBP', 'Chronic Low Back Pain']","['placebo', 'Placebo Response Reduction (PRR) training program-to placebo', 'Placebo']","['percentage of placebo responders', 'pain intensity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.436272,The percentage of placebo responders was statistically significantly lower in the SPRINT study (19.1%) compared with other CLBP trials (38.0%) (P=0.003).,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Erpelding', 'Affiliation': 'Parexel International, Billerica MA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': 'Analgesic Solutions, LLC, Wayland MA, USA.'}, {'ForeName': 'Ryan K', 'Initials': 'RK', 'LastName': 'Lanier', 'Affiliation': 'Canopy Growth, Smith Falls ON, Canada.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Elder', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond VA, USA.'}, {'ForeName': 'Nathaniel Paul', 'Initials': 'NP', 'LastName': 'Katz', 'Affiliation': 'Analgesic Solutions, LLC, Wayland MA, USA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000873']
2270,32842013,"Pre-emptive topical lidocaine 5% plaster for prevention of post-craniotomy pain: a protocol for a multicentred, randomized, triple-blind, placebo-controlled clinical trial.",,2020,,[],"['placebo', 'lidocaine']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]",[],,0.530178,,"[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Peking University Third Hospital, Center for Precision Neurosurgery and Oncology, Peking University Health Science Center, Beijing 100191, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001066']
2271,32842052,"Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial.","OBJECTIVE


To evaluate the effect of a single-capsule, bioidentical 17β-estradiol (E2) and progesterone (P4) hormone therapy on mammograms and breasts in postmenopausal women after 1 year of use.
METHODS


In the 12-month, phase 3, randomized, double-blind, placebo-controlled, multicenter REPLENISH trial, postmenopausal women (40-65 y) with moderate to severe vasomotor symptoms and a uterus were randomized to four active daily dose groups of E2/P4 (TX-001HR) or a placebo group. Mammograms were performed and read locally at screening (or ≤6 months before first dose) and at study end using BI-RADS classification. Incidence of abnormal mammograms and breast adverse events was evaluated.
RESULTS


All but 8 (0.4%) mammograms at screening were normal (BI-RADS 1 or 2). At 1 year, 39 (2.9%) of the 1,340 study-end mammograms were abnormal (BI-RADS 3 or 4); incidence was 1.7% to3.7% with active doses and 3.1% with placebo. Breast cancer incidence was 0.36% with active doses and 0% with placebo. Breast tenderness was reported at frequencies of 2.4% to 10.8% with active doses versus 0.7% with placebo, and led to eight study discontinuations (1.6% of discontinuations in active groups).
CONCLUSIONS


In this phase 3 trial of a combined E2/P4, results of secondary outcomes suggest that E2/P4 may not be associated with increased risk of abnormal mammograms versus placebo, and the incidence of breast tenderness was low relative to most of the rates reported in other studies using hormone therapy.",2020,"At 1 year, 39 (2.9%) of the 1,340 study-end mammograms were abnormal (BI-RADS 3 or 4); incidence was 1.7% to3.7% with active doses and 3.1% with placebo.","['mammograms and breasts in postmenopausal women after 1 year of use', 'menopausal women', 'postmenopausal women (40-65 y) with moderate to severe vasomotor symptoms and a uterus']","['placebo', 'oral, combined 17β-estradiol, and progesterone capsules', 'single-capsule, bioidentical 17β-estradiol (E2) and progesterone (P4) hormone therapy', 'E2/P4 (TX-001HR']","['Incidence of abnormal mammograms and breast adverse events', 'Breast tenderness', 'Breast cancer incidence', 'risk of abnormal mammograms']","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0262365', 'cui_str': 'Mammography abnormal'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0262397', 'cui_str': 'Breast tenderness'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.637879,"At 1 year, 39 (2.9%) of the 1,340 study-end mammograms were abnormal (BI-RADS 3 or 4); incidence was 1.7% to3.7% with active doses and 3.1% with placebo.","[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Denise R', 'Initials': 'DR', 'LastName': 'Black', 'Affiliation': 'University of Manitoba, Winnipeg MB, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Larkin', 'Affiliation': 'Ms.Medicine, Cincinnati, OH.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001631']
2272,32842136,Whether Orthotic Management and Exercise are Equally Effective to the Patients With Adolescent Idiopathic Scoliosis in Mainland China?: A Randomized Controlled Trial Study: Erratum.,,2020,,[],['Orthotic Management and Exercise'],[],[],"[{'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0396738,,[],Spine,['10.1097/BRS.0000000000003649']
2273,32842178,[The efficacy of OM85-BV in the treatment of recurrent upper respiratory tract infection with adenoid hypertrophy and the preliminary exploration of potential therapeutic mechanism].,"Objective: To observe the efficacy of OM85-BV in the treatment of recurrent upper respiratory tract infection with adenoid hypertrophy and to explore its possible mechanism.  Method: Four hundred and forty-eight children with recurrent upper respiratory tract infection and adenoid hypertrophy were collected. Three hundred and twenty-six patients in the control group were treated with conventional drugs, and one hundred and twenty-two patients in the observation group were treated with OM85-BV+conventional drugs, and the treatment lasted 12 weeks. The sleep obstructive symptoms of adenoid hypertrophy were scored according to OSA-18 before and after the treatment respectively（0, 6, 12 weeks）. The symptoms scores and effective rate of treatment between the study and the control group were compared. The patients in the control group and the observation group who were unresponsive to drug treatment received surgery after 12 weeks of drug treatment. The levels of serum IL-2, IL-4, IL-6, IL-10, TNF, IFN-γ and IgE, the ratio of serum CD3, CD4, CD8 in lymphocytes and the ratio of CD4/CD8 were compared between the study and the control group before operation. The levels of HBD-2, IFN-γ, IL-4, IL-6 cytokines in the adenoid were compared between the control group and the observation group. The expression and distribution of adenoid HBD-2, IFN-γ, IL-4, IL-6 were compared between the control group and the observation group.  Result: After 12 weeks of treatment, the total effective rate of the observation group was significantly higher than that of the control group, and the improvement of sleep respiratory obstruction symptoms of children with recurrent upper respiratory tract infection and adenoid hypertrophy was also much better than that of the control group. The serum IFN-γ of the observation group was significantly higher than that of the control group, and there was no significant difference in serum IL-2, IL-4, IL-6, IL-10, TNF, IgE between the observation group and the control group. There was no significant difference in serum CD3, CD4, CD8 and CD4/CD8 between the observation group and the control group. In the observation group, the adenoid HBD-2 was significantly higher but IL-4, IFN-γ were significantly lower than that in the control group, and IL-6 had no significant difference compared with the control group.  Conclusion: OM85-BV can significantly improve the sleep apnea symptoms but can not rise the level of immune lymphocytes in children with adenoid hypertrophy and recurrent upper respiratory tract infection.OM85-BV can improve the Th1 immune response, enhancing the ability of human body to fight against pathogens and induce the release of HBD-2, increasing the resistance to microorganisms, reducing the bacteria aggregation, weakening the local inflammatory response in adenoids.",2020,"In the observation group, the adenoid HBD-2 was significantly higher but IL-4, IFN-γ were significantly lower than that in the control group, and IL-6 had no significant difference compared with the control group.  ","['children with adenoid hypertrophy and recurrent upper respiratory tract infection', 'Four hundred and forty-eight children with recurrent upper respiratory tract infection and adenoid hypertrophy were collected']","['OM85-BV+conventional drugs', 'conventional drugs', 'OM85-BV']","['adenoid HBD-2', 'sleep obstructive symptoms of adenoid hypertrophy', 'serum IFN-γ', 'levels of serum IL-2, IL-4, IL-6, IL-10, TNF, IFN-γ and IgE, the ratio of serum CD3, CD4, CD8 in lymphocytes and the ratio of CD4/CD8', 'total effective rate', 'expression and distribution of adenoid HBD-2, IFN-γ, IL-4, IL-6', 'serum IL-2, IL-4, IL-6, IL-10, TNF, IgE', 'sleep apnea symptoms', 'levels of HBD-2, IFN-γ, IL-4, IL-6 cytokines', 'sleep respiratory obstruction symptoms', 'serum CD3, CD4, CD8 and CD4/CD8', 'symptoms scores and effective rate', 'IL-4, IFN-γ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0581381', 'cui_str': 'Recurrent upper respiratory tract infection'}, {'cui': 'C4517777', 'cui_str': '440'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",448.0,0.0196118,"In the observation group, the adenoid HBD-2 was significantly higher but IL-4, IFN-γ were significantly lower than that in the control group, and IL-6 had no significant difference compared with the control group.  ","[{'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Karamay Central Hospital，Xinjiang Autonomous Region.'}, {'ForeName': 'Jiahua', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Cao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.06.005']
2274,32842183,[The efficacy of hyperbaric oxygen in the treatment of sudden sensorineural hearing loss].,"Objective: To investigate the therapeutic effect of hyperbaric oxygen on sudden sensorineural hearing loss（SSNHL）.  Method: One hundred and seven patients with SSNHL were selected, and were randomly divided into 3 groups according to admission order. Therapeutic schedule in group A （38 cases） consisted of hyperbaric oxygen treatment once a day for 10 consecutive days, then 1 day off treatment, and on treatment for another 10 consecutive days （20 treatments in total）. Twenty-seven patients in group B were treated with hyperbaric oxygen twice per day for a total of 10 days. Forty-two patients in group C didn't receive hyperbaric oxygen therapy. Meanwhile, all patients were given conventional treatment for 14 days in accordance with the recommendations of the otolaryngology, head and neck branch of the Chinese medical association for the diagnosis and treatment of sudden sensorineural hearing loss. Patients in group A underwent pure tone audiometry after the end of treatment, and patients in group B and C were reexamined 20 days after the start of treatment, and the treatment efficacy of the three groups was compared.  Result: The overall effective rate of group A was 78.9%, and the improvement of hearing threshold was（27.2±17.5） dB HL. In group B, the overall effective rate was 81.5%, and the improvement of threshold value was（26.9±16.7） dB HL. The overall effective rate of group C was 61.9%, and the improvement of threshold value o was（17.6±18.5） dB HL. The effective rate of group C was significantly higher than that of group A or B, while there was no significant difference in efficacy between group A and group B.  Conclusion: The efficacy of hyperbaric oxygen combined with drug therapy for SSNHL is better than that of drug therapy alone. Programs of different hyperbaric oxygen combined with drug therapy can be selected on an individual basis.",2020,"The effective rate of group C was significantly higher than that of group A or B, while there was no significant difference in efficacy between group A and group B.  Conclusion:","['sudden sensorineural hearing loss', 'One hundred and seven patients with SSNHL', 'sudden sensorineural hearing loss（SSNHL）']","['hyperbaric oxygen treatment', 'hyperbaric oxygen combined with drug therapy', 'hyperbaric oxygen therapy', 'hyperbaric oxygen']","['overall effective rate', 'efficacy', 'hearing threshold was（27.2±17.5', 'effective rate']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",107.0,0.016149,"The effective rate of group C was significantly higher than that of group A or B, while there was no significant difference in efficacy between group A and group B.  Conclusion:","[{'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}, {'ForeName': 'Hongjiang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}, {'ForeName': 'Wenfang', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.06.010']
2275,32831511,"Effectiveness of fluoride varnish, diode laser, and their combination in treatment of dentin hypersensitivity: A randomized split-mouth clinical trial.","Background


Dentin hypersensitivity is a common dental problem with no permanent cure and predictable prognosis.
Aim


The aim of this study was to evaluate the effectiveness of fluoride varnish (sodium fluoride [NaF]), diode laser, and the combination of NaF and diode laser in the treatment of dentin hypersensitivity.
Settings and Design


This was a randomized split-mouth clinical trial.
Materials and Methods


Sixty patients aged 20-60 years suffering from dentin hypersensitivity to air-blast, cold, and tactile stimulation corresponding to 4 cm and above on the Visual Analog Scale (VAS) in three quadrants with at least two hypersensitive teeth per quadrant were selected. Hypersensitive teeth were allotted to Group 1 - 5% NaF varnish application alone, Group 2 - 810-nm gallium-aluminum-arsenide laser (GaAlAs) diode laser (0.5 W) irradiation alone, and Group 3 - NaF varnish application, followed by diode laser irradiation. VAS score was recorded at baseline, 1 week, 2 weeks, 1 month, 3 months, and 6 months.
Results


A statistically significant reduction in dentin hypersensitivity was observed in all the three groups, from the baseline to the 1 st -, 3 rd -, and 6 th -month follow-ups ( P  < 0.05). Group 2 and Group 3 demonstrated a significantly higher reduction ( P  < 0.05) in dentin hypersensitivity for all the stimuli as opposed to Group 1 at all follow-up intervals. However, no statistically significant difference ( P  > 0.05) was present between Group 2 and Group 3 at all follow-ups.
Conclusion


Diode laser is significantly more effective than fluoride varnish alone in the treatment of dentin hypersensitivity over a period of 6 months.",2020,Group 2 and Group 3 demonstrated a significantly higher reduction ( P  < 0.05) in dentin hypersensitivity for all the stimuli as opposed to Group 1 at all follow-up intervals.,"['dentin hypersensitivity', 'Sixty patients aged 20-60 years suffering from dentin hypersensitivity to air-blast, cold, and tactile stimulation corresponding to 4 cm and above on the Visual Analog Scale (VAS) in three quadrants with at least two hypersensitive teeth per quadrant were selected']","['fluoride varnish, diode laser, and their combination', 'fluoride varnish (sodium fluoride [NaF]), diode laser, and the combination of NaF and diode laser', 'NaF varnish application alone, Group 2 - 810-nm gallium-aluminum-arsenide laser (GaAlAs) diode laser (0.5 W) irradiation alone, and Group 3 - NaF varnish application, followed by diode laser irradiation', 'Diode laser']","['dentin hypersensitivity', 'VAS score']","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1269095', 'cui_str': 'Gallium aluminum arsenide semiconductor laser device'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.0509527,Group 2 and Group 3 demonstrated a significantly higher reduction ( P  < 0.05) in dentin hypersensitivity for all the stimuli as opposed to Group 1 at all follow-up intervals.,"[{'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Periodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Department of Periodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pal', 'Affiliation': 'Department of Periodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Oral Surgery, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_494_19']
2276,32831540,Laparoscopic Posterior Versus Lateral Transversus Abdominis Plane Block in Gynecology.,"Background and Objectives


Transversus abdominis plane (TAP) block is a safe and effective type of regional anesthesia technique used in laparoscopic gynecologic surgery to minimize postoperative pain. Our study aimed to compare the analgesic effects of the posterior versus lateral approaches to laparoscopic-assisted TAP block in minimally invasive gynecologic surgery.
Methods


We performed a randomized controlled trial with 82 patients allocated to either posterior (n = 38) or lateral (n = 44) TAP block groups. Laparoscopic-assisted posterior or lateral TAP block was administered using liposomal bupivacaine mixture. All subjects were asked to fill out a questionnaire, which included postoperative pain scores at 6 h, 12 h, 24 h, 48 h, and 72 h, as well as narcotic utilization postoperatively. Both groups were compared for postoperative pain scores, opioid consumption, perioperative, and demographic characteristics.
Results


A total of 67 patients were analyzed in our study (n = 33 in posterior arm, n = 34 in lateral arm). Demographic characteristics including race, body mass index, comorbidities, American Society of Anesthesiologists classification, pre-operative diagnosis, complication rates, length of stay, and estimated blood loss were comparable between the two groups. The distribution of different operative procedures was similar between the two groups. There was no statistically significant difference in pain scores at 6 h, 12 h, 24 h, 48 h, and 72 h postoperatively between the two groups. However, patients receiving posterior TAP had a significant reduction in narcotic intake ( p  = 0.0009).
Conclusion


Laparoscopic-assisted TAP block is a safe and effective option for regional analgesia in laparoscopic gynecologic surgery. Posterior TAP block may help to reduce narcotic usage postoperatively.",2020,"However, patients receiving posterior TAP had a significant reduction in narcotic intake ( p  = 0.0009).
","['Gynecology', '67 patients were analyzed in our study (n = 33 in posterior arm, n = 34 in lateral arm', 'laparoscopic gynecologic surgery', '82 patients allocated to either posterior (n = 38) or lateral (n = 44) TAP block groups']","['Laparoscopic Posterior Versus Lateral Transversus Abdominis Plane Block', 'Laparoscopic-assisted TAP block', 'Laparoscopic-assisted posterior or lateral TAP block', 'Transversus abdominis plane (TAP) block', 'liposomal bupivacaine mixture', 'posterior versus lateral approaches to laparoscopic-assisted TAP block']","['analgesic effects', 'narcotic intake', 'postoperative pain scores, opioid consumption, perioperative, and demographic characteristics', 'postoperative pain scores', 'Demographic characteristics including race, body mass index, comorbidities, American Society of Anesthesiologists classification, pre-operative diagnosis, complication rates, length of stay, and estimated blood loss', 'pain scores']","[{'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",67.0,0.404246,"However, patients receiving posterior TAP had a significant reduction in narcotic intake ( p  = 0.0009).
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Benabou', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Soorin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Christina H', 'Initials': 'CH', 'LastName': 'Tierney', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Messom', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Tassos C', 'Initials': 'TC', 'LastName': 'Kyriakides', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health.'}, {'ForeName': 'Shabnam M', 'Initials': 'SM', 'LastName': 'Kashani', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Dan-Arin', 'Initials': 'DA', 'LastName': 'Silasi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Azodi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Farinaz', 'Initials': 'F', 'LastName': 'Seifi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00032']
2277,32831851,Does Luteal Phase Support Effect Pregnancy Rates in Intrauterine Insemination Cycles? A Prospective Randomised Controlled Study in a Tertiary Center.,"Intrauterine insemination (IUI) is a common treatment for couples with subfertility. Clomiphene citrate, gonadotropins, and letrozole are used for ovulation induction in IUI cycles. It has been well documented that luteal support with exogenous progesterone after in vitro fertilization is associated with higher pregnancy and live birth rates. Yet, luteal phase support in IUI cycles has become a debatable issue. The aim of this prospective controlled study was to assess the effect of luteal phase vaginal progesterone supplementation on  β -hCG positivity and clinical pregnancy rates in women undergoing IUI. This prospective controlled randomised study was conducted at a tertiary infertility center. 87 patients with unexplained infertility or male subfertility who were treated with IUI using gonadotropins were enrolled. Patients in the study group ( n  = 44) received luteal phase vaginal progesterone supplementation. Patients in the control group ( n  = 43) did not receive any luteal phase support. There was no statistical difference between two groups in terms of  β -hCG positivity and clinical pregnancy rates. Our findings do not show any beneficial effect of luteal phase support in IUI cycles stimulated with gonadotropins. Although luteal phase support in IUI cycles stimulated with gonadotropins is widely adopted, there is a lack of robust evidence.",2020,There was no statistical difference between two groups in terms of  β -hCG positivity and clinical pregnancy rates.,"['women undergoing IUI', 'couples with subfertility', '87 patients with unexplained infertility or male subfertility who were treated with IUI using gonadotropins were enrolled']","['Clomiphene citrate, gonadotropins, and letrozole', 'Intrauterine insemination (IUI', 'luteal phase vaginal progesterone supplementation']",['β -hCG positivity and clinical pregnancy rates'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0341869', 'cui_str': 'Sub-Fertility, Female'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0848676', 'cui_str': 'Sub-Fertility, Male'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",87.0,0.0541547,There was no statistical difference between two groups in terms of  β -hCG positivity and clinical pregnancy rates.,"[{'ForeName': 'Müge', 'Initials': 'M', 'LastName': 'Keskin', 'Affiliation': 'Department of Obstetrics and Gynecology, Ufuk University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ruşen', 'Initials': 'R', 'LastName': 'Aytaç', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine, Ankara, Turkey.'}]",Obstetrics and gynecology international,['10.1155/2020/6234070']
2278,32831868,"Effect of Foot Reflexology on Pain, Fatigue, and Quality of Sleep after Kidney Transplantation Surgery: A Parallel Randomized Controlled Trial.","Materials and Methods


The study was a parallel randomized controlled trial. Patients admitted to the transplantation ward participated in the study. Fifty-three eligible patients were allocated into the foot reflexology group ( n  = 26) and the control group ( n  = 27) by using the stratified randomization method. Finally, 25 participants in each group finished the study. The intervention group received foot reflexology for 30 minutes once a day for three consecutive days, and no reflexology was applied in the control group. The intervention started on the second day after surgery. Pain, fatigue, and quality of sleep were measured on the first, second (before intervention), third, fourth, and eleventh days after surgery. Data were collected using visual analogue scale for measuring pain and fatigue and Verran and Snyder-Halpern sleep scale for measuring quality of sleep.
Results


In each group, 25 patients finished the study. The mean pain score in the foot reflexology and control groups decreased from 9.44 ± 0.96 and 9.36 ± 0.91 on the day of surgery to 1.32 ± 0.94 and 4.32 ± 1.68 on the eleventh day after surgery, respectively. The mean fatigue score in the reflexology and control groups decreased from 8.76 ± 1.27 and 8.6 ± 1.26 on the day of surgery to 1.24 ± 1.2 and 3.92 ± 1.63 on the eleventh day after surgery, respectively. The mean sleep score in the foot reflexology and control groups increased from 33.38 ± 11.22 and 39.59 ± 12.8 on the day of surgery to 69.43 ± 12.8 and 56.27 ± 8.03 on the eleventh day after surgery, respectively. While pain, fatigue, and sleep quality scores improved in both groups, those in the intervention group showed significantly greater improvement compared with the control group ( P  < 0.001). No significant difference was found between the two groups in the use of acetaminophen on the first, second, third, fourth, and eleventh days after surgery ( P  > 0.05).
Conclusion


Foot reflexology may reduce pain and fatigue and improve sleep quality of patients after kidney transplantation.",2020,"No significant difference was found between the two groups in the use of acetaminophen on the first, second, third, fourth, and eleventh days after surgery ( P  > 0.05).
","['25 participants in each group finished the study', 'after Kidney Transplantation Surgery', '25 patients finished the study', 'Fifty-three eligible patients', 'Patients admitted to the transplantation ward participated in the study', 'patients after kidney transplantation']","['acetaminophen', 'foot reflexology', 'Foot Reflexology']","['mean pain score', 'While pain, fatigue, and sleep quality scores', 'Pain, fatigue, and quality of sleep', 'pain and fatigue and improve sleep quality', 'visual analogue scale for measuring pain and fatigue and Verran and Snyder-Halpern sleep scale', 'mean fatigue score', 'Pain, Fatigue, and Quality of Sleep', 'mean sleep score']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",53.0,0.0305396,"No significant difference was found between the two groups in the use of acetaminophen on the first, second, third, fourth, and eleventh days after surgery ( P  > 0.05).
","[{'ForeName': 'Atena', 'Initials': 'A', 'LastName': 'Samarehfekri', 'Affiliation': 'Nursing Research Center, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Department of Critical Care Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Arab', 'Affiliation': 'Faculty of Nursing and Midwifery, Bam University of Medical Sciences, Bam, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ebadzadeh', 'Affiliation': 'Department of Urology, School of Medicine, Physiology Research Center, Neuropharmacology Research Institute, Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5095071']
2279,32831871,Effect of Transcutaneous Vagus Nerve Stimulation at Auricular Concha for Insomnia: A Randomized Clinical Trial.,"Insomnia inflicts mental burden and decreases physical productivity and affects life quality. Transcutaneous vagus nerve stimulation (ta-VNS) may be an effective treatment option for insomnia. This study aims to evaluate the effect and safety of ta-VNS and compare it with transcutaneous nonvagus nerve stimulation (tn-VNS). A multicenter, randomized, clinical trial was conducted at 3 hospitals in China enrolling 72 insomnia participants from May 2016 to June 2017. Participants were randomly assigned (1 : 1) to receive 40 sessions of ta-VNS or tn-VNS treatment. 63 participants completed the trial. ta-VNS treatment significantly decreased the Pittsburgh Sleep Quality Index score, Epworth Sleepiness Scale score, Flinders Fatigue Scale score, Hamilton Depression Scale score, and Hamilton Anxiety Scale score over 4 weeks compared with those of the baseline. Moreover, it also significantly increased the 36-item Short-Form Health Survey Questionnaire scores compared with that of the baseline. However, it did not show significant differences compared with tn-VNS in changes of primary and secondary outcomes. The incidence of adverse events was low. ta-VNS significantly relieved insomnia over 4 weeks. Moreover, it also alleviated fatigue and improved participants' quality of life as well as other concomitant symptoms such as depression and anxiety. This trial is registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn) with the registration number: ChiCTR-TRC-13003519.",2020,"ta-VNS treatment significantly decreased the Pittsburgh Sleep Quality Index score, Epworth Sleepiness Scale score, Flinders Fatigue Scale score, Hamilton Depression Scale score, and Hamilton Anxiety Scale score over 4 weeks compared with those of the baseline.","['Auricular Concha for Insomnia', '3 hospitals in China enrolling 72 insomnia participants from May 2016 to June 2017', '63 participants completed the trial']","['ta-VNS', 'transcutaneous nonvagus nerve stimulation (tn-VNS', '40 sessions of ta-VNS or tn-VNS treatment', 'Transcutaneous vagus nerve stimulation (ta-VNS', 'Transcutaneous Vagus Nerve Stimulation']","['36-item Short-Form Health Survey Questionnaire scores', 'adverse events', 'insomnia', 'physical productivity and affects life quality', ""alleviated fatigue and improved participants' quality of life"", 'Pittsburgh Sleep Quality Index score, Epworth Sleepiness Scale score, Flinders Fatigue Scale score, Hamilton Depression Scale score, and Hamilton Anxiety Scale score']","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0229316', 'cui_str': 'Concha of ear structure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",72.0,0.156178,"ta-VNS treatment significantly decreased the Pittsburgh Sleep Quality Index score, Epworth Sleepiness Scale score, Flinders Fatigue Scale score, Hamilton Depression Scale score, and Hamilton Anxiety Scale score over 4 weeks compared with those of the baseline.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Suxia', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'National Institute on Drug Dependence, Peking University, Beijing 100191, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Neurology Department, Xuanwu Hospital of Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Chinese Medicine Data Center, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Dequan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'National Institute on Drug Dependence, Peking University, Beijing 100191, China.'}, {'ForeName': 'Zaifang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'National Institute on Drug Dependence, Peking University, Beijing 100191, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'National Institute on Drug Dependence, Peking University, Beijing 100191, China.'}, {'ForeName': 'Mozheng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Peijing', 'Initials': 'P', 'LastName': 'Rong', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/6049891']
2280,32831874,Five-Animal Frolics Exercise Improves Anxiety and Depression Outcomes in Patients with Coronary Heart Disease: A Single-Blind Randomized Controlled Trial.,"Introduction


The patients with coronary heart disease (CHD) always have emotional implications. As the branch of traditional Chinese medicine, Five-Animal Frolics Exercise (FAE) is a popular mind-body exercise in China and shown to improve emotional wellbeing.
Aim


We aimed to explore the effects of FAE on the emotional disorders of CHD patients.
Methods


CHD patients were assigned into an experiment group (EG, FAE) and a control group (CG, routine nursing care). We measured serum levels of miR-124 and miR-135 and scores of the Hamilton Depression/Anxiety scale (HAMD/HAMA), Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Short Form 36 Health Survey Questionnaire (SF-36), and Pittsburgh Sleep Quality Index (PSQI).
Results


After a 3-month FAE intervention, serum levels of miR-124 and miR-135 and the scores of HAMD/HAMA, SAS, SDS, and PSQI in the EG group were lower than those in the CG group, while SF-36 scores in the EG group were higher than those in the CG group ( p  < 0.05). Serum levels of miR-124 and miR-135 had a strong relationship with SAS and SDS scores ( p  < 0.05).  Discussion/Implications for Practice . The study suggests that FAE intervention controls anxiety and depression outcomes and improves life quality in CHD patients by affecting serum levels of miR-124 and miR-135.",2020,Serum levels of miR-124 and miR-135 had a strong relationship with SAS and SDS scores ( p  < 0.05).  ,"['Patients with Coronary Heart Disease', 'patients with coronary heart disease (CHD) always have emotional implications', 'CHD patients']","['FAE', 'FAE intervention', 'Five-Animal Frolics Exercise', 'Five-Animal Frolics Exercise (FAE']","['Anxiety and Depression Outcomes', 'serum levels of miR-124 and miR-135 and the scores of HAMD/HAMA, SAS, SDS, and PSQI', 'SAS and SDS scores', 'life quality', 'serum levels of miR-124 and miR-135 and scores of the Hamilton Depression/Anxiety scale (HAMD/HAMA), Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Short Form 36 Health Survey Questionnaire (SF-36), and Pittsburgh Sleep Quality Index (PSQI', 'controls anxiety and depression outcomes', 'SF-36 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2743231', 'cui_str': 'Mirn124a microRNA, human'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1291910', 'cui_str': 'Human anti-mouse antibody'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0338226,Serum levels of miR-124 and miR-135 had a strong relationship with SAS and SDS scores ( p  < 0.05).  ,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Qingbao', 'Initials': 'Q', 'LastName': 'Chi', 'Affiliation': 'Department of Spine Surgery, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Shui', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/6937158']
2281,32831875,Efficacy of Piroxicam Mesotherapy in Treatment of Knee Osteoarthritis: A Randomized Clinical Trial.,"Introduction


Knee osteoarthritis (KOA) is one of the most common degenerative diseases that lead to pain and disability. Oral NSAIDs are effective drugs used to alleviate symptoms in patients with KOA, but they have several important complications, especially in the elderly. In this study, we evaluated the effectiveness of mesotherapy on pain reduction and improvement of functioning in patients with KOA.
Methods


Sixty-two patients with KOA, grade 2-3 of the Kellgren-Lawrence scale, were randomized into two groups: the mesotherapy group, in which two injections were applied with piroxicam at a 10-day interval, and the oral group, in which piroxicam was prescribed for 10 days. The patients were evaluated before the treatment and 2, 4, and 8 weeks after it using the Visual Analogue Scale (VAS), Oxford Knee Scare (OKS), and Western Ontario McMaster University Osteoarthritis Index (WOMAC, Persian version).
Results


There was no significant difference in demographic characteristics and baseline pain and function scores between the two groups. After 2, 4, and 8 weeks of follow-up, VAS, WOMAC, and OKS scores significantly improved in both groups (in the mesotherapy group:  p  value <0.001 in all three scores and in the oral group:  p  value <0.001 in the VAS scale and  p  value <0.05 in WOMAC and OKS scores). There was no significant difference between the two groups at any time in the VAS score, but improvement in WOMAC and OKS scales in the mesotherapy group was significantly better ( p  value <0.05 in both scales [ p  value <0.03 in OKS and  p  value <0.02 in WOMAC scales]). Side effects in both groups were not serious: limited heart burn in 32.2% of the total subjects in the oral group and pain at the injection site in 3.2% and bruises in 38.7% of the total subjects in the mesotherapy group.
Conclusion


Mesotherapy is an effective and safe treatment modality in patients with mild-to-moderate KOA in the short term. This trial is registered with IRCT2017052434113N1.",2020,"There was no significant difference between the two groups at any time in the VAS score, but improvement in WOMAC and OKS scales in the mesotherapy group was significantly better ( p  value <0.05 in both scales [ p  value <0.03 in OKS and  p  value","['Methods\n\n\nSixty-two patients with KOA, grade 2-3 of the Kellgren-Lawrence scale', 'patients with KOA', 'Knee Osteoarthritis', 'patients with mild-to-moderate KOA in the short term']","['piroxicam', 'mesotherapy', 'Mesotherapy', 'Piroxicam Mesotherapy']","['Side effects', 'pain', 'VAS score', 'Visual Analogue Scale (VAS), Oxford Knee Scare (OKS), and Western Ontario McMaster University Osteoarthritis Index (WOMAC, Persian version', 'VAS, WOMAC, and OKS scores', 'WOMAC and OKS scales', 'demographic characteristics and baseline pain and function scores', 'pain reduction and improvement of functioning']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C2242515', 'cui_str': 'Mesotherapy'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",62.0,0.025441,"There was no significant difference between the two groups at any time in the VAS score, but improvement in WOMAC and OKS scales in the mesotherapy group was significantly better ( p  value <0.05 in both scales [ p  value <0.03 in OKS and  p  value","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Farpour', 'Affiliation': 'Shiraz Geriatric Research Center, Department of Physical Medicine and Rehabilitation, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Estakhri', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohadese', 'Initials': 'M', 'LastName': 'Zakeri', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Parvin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/6940741']
2282,32831908,"Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients with type 2 diabetes mellitus: a randomized, double-blind, clinical trial.","Background


Patients with type 2 diabetes mellitus (T2DM) are characterized by chronic hyperglycemia as a consequence of decreased insulin sensitivity, which contributes to bone demineralization and could also be related to changes in serum levels of osteocalcin and insulin, particularly when coupled with a deficiency in the daily consumption of vitamins D3 and K2. The objective of this study was to evaluate the effect of vitamin D3 and vitamin K2 supplements alone or in combination on osteocalcin levels and metabolic parameters in patients with T2DM.
Methods


A double-blind, randomized clinical trial was carried out in 40 patients aged between 30 and 70 years old for 3 months. Clinical and laboratory assessment was carried out at the beginning and at the end of the treatment. The patients were divided into three groups: (a) 1000 IU vitamin D3 + a calcinated magnesium placebo (n = 16), (b) 100 µg of Vitamin K2 + a calcinated magnesium placebo (n = 12), and (c) 1000 IU vitamin D3 + 100 µg vitamin K2 (n = 12).
Results


After treatment in the total studied population, a significant decrease in glycemia (p = 0.001), HOMA-IR (Homeostatic model assessment-insulin resistance) (p = 0.040), percentage of pancreatic beta cells (p < 0.001), uOC/cOC index and diastolic blood pressure (p = 0.030) were observed; in vitamin D3 group, differences in serum undercarboxylated osteocalcin (p = 0.026), undercarboxylated to carboxylated osteocalcin index (uOC/cOC) (p = 0.039) glucose (p < 0.001) and  % of functional pancreatic beta cells (p < 0.001) were demonstrated. In vitamin K2 group a significant decrease in glycemia (p = 0.002), HOMA-IR (p = 0.041), percentage of pancreatic beta cells (p = 0.002), and in cOC (p = 0.041) were observed, conversely cOC concentration was found high. Finally, in the vitamins D3 + K2 a significant decrease in glycemia (p = 0.002), percentage of pancreatic beta cells (p = 0.004), and in the uOC/cOC index (p = 0.023) were observed.
Conclusion


Individual or combined supplementation with vitamins D3 and K2 significantly decreases the glucose levels and  % of functional pancreatic beta cells, while D3 and D3 + K2 treatments also induced a reduction in the uOC/cOC index. Only in the group with vitamin D3 supplementation, it was observed a reduction in undercarboxylated osteocalcin while vitamin K2 increased the carboxylated osteocalcin levels. Trial registration  NCT04041492.",2020,"In vitamin K2 group a significant decrease in glycemia (p = 0.002), HOMA-IR (p = 0.041), percentage of pancreatic beta cells (p = 0.002), and in cOC (p = 0.041) were observed, conversely cOC concentration was found high.","['patients with type 2 diabetes mellitus', '40 patients aged between 30 and 70\xa0years old for 3\xa0months', '\n\n\nPatients with type 2 diabetes mellitus (T2DM', 'patients with T2DM']","['supplementation with vitamins D3 and K2', 'Vitamin K2\u2009+\u2009a calcinated magnesium placebo', 'vitamin K2', 'vitamin D3 and vitamin K2 supplements', 'vitamin D3\u2009+\u2009a calcinated magnesium placebo', 'vitamin D3 supplementation', 'vitamin D3\u2009+\u2009100\xa0µg vitamin K2']","['carboxylated osteocalcin levels', 'osteocalcin levels and metabolic parameters', 'functional pancreatic beta cells', 'glucose levels', 'undercarboxylated to carboxylated osteocalcin index (uOC/cOC', 'HOMA-IR', 'percentage of pancreatic beta cells', 'serum undercarboxylated osteocalcin', 'glycemia', 'undercarboxylated osteocalcin while vitamin K2', 'undercarboxylated osteocalcin and insulin serum levels', 'uOC/cOC index', 'uOC/cOC index and diastolic blood pressure', 'HOMA-IR (Homeostatic model assessment-insulin resistance', 'conversely cOC concentration', 'cOC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",40.0,0.206561,"In vitamin K2 group a significant decrease in glycemia (p = 0.002), HOMA-IR (p = 0.041), percentage of pancreatic beta cells (p = 0.002), and in cOC (p = 0.041) were observed, conversely cOC concentration was found high.","[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Aguayo-Ruiz', 'Affiliation': 'Pharmacology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'García-Cobián', 'Affiliation': 'Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pascoe-González', 'Affiliation': 'Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sánchez-Enríquez', 'Affiliation': 'Department of Clinics, Altos University Center (CuAltos), Universidad de Guadalajara (UdeG), 47620 Tepatitlán de Morelos, Jalisco Mexico.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Llamas-Covarrubias', 'Affiliation': 'Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'García-Iglesias', 'Affiliation': 'Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'López-Quintero', 'Affiliation': 'Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Llamas-Covarrubias', 'Affiliation': 'Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Trujillo-Quiroz', 'Affiliation': 'Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rivera-Leon', 'Affiliation': 'Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-020-00580-w']
2283,32832109,Evaluation of the impact of delayed centrifugation on the diagnostic performance of serum creatinine as a baseline measure of renal function before antiretroviral treatment.,"Background


The measurement of serum creatinine is a standard requirement of the medical management of people living with HIV. Renal dysfunction is common, both as a complication of HIV-infection and as a result of its treatment. The detection of abnormal renal function before the start of antiretroviral therapy will impact patient management and the outcome of treatment.
Objectives


This study aimed to determine if a time delay in the centrifugation of serum samples affected the creatinine level and the estimated glomerular filtration rate as recorded on the analytical platforms used in the laboratory.
Methods


Twenty-two ( n  = 22) HIV-positive, newly diagnosed and treatment-naïve patients were randomly recruited from Alexandra Health Clinic, Johannesburg, South Africa. Serum samples were centrifuged at six time intervals following receipt of the sample viz. < 4 h (baseline), 6 h, 24 h, 48 h, 72 h and 96 h. Creatinine concentrations were measured on the Roche platform utilising the enzymatic and kinetic Jaffe methods. Whole blood samples were also analysed with the Abbott i-STAT point-of-care instrument. The estimated glomerular filtration rate was calculated using the Cockcroft Gault, CKD-Epidemiology Collaboration and Modified Diet and Renal Disease v3/4 equations.
Results


At baseline (< 4 h) there was good agreement between the enzymatic and kinetic Jaffe methods: bias 1.7 µmol/l. The enzymatic and i-STAT creatinine concentrations were stable over 96 h viz. changes of 1.8% and 5.7%. However, from 24 h onwards agreement between the enzymatic and kinetic Jaffe methods was poor with the latter measuring 43.7 µmol/l higher than the enzymatic method at 96 h. Creatinine concentrations measured with the kinetic Jaffe method increased significantly in samples centrifuged after 6 h ( p  < 0.001, 61.7% change), and resulted in a 95% decline in eGFR at 96 h as determined with the CKD-Epidemiology Collaboration equation.
Conclusion


The analysis of serum creatinine using the isotope dilution mass spectrometry traceable kinetic Jaffe method is unreliable if performed on samples centrifuged ≥ 6 h after collection. The raised creatinine concentration can affect clinical decisions such as renal functional assessment, choice of antiretroviral drug or regimen, and the dose and frequency of medication.",2020,The enzymatic and i-STAT creatinine concentrations were stable over 96 h viz.,"['Methods\n\n\nTwenty-two ( n  = 22) HIV-positive, newly diagnosed and treatment-naïve patients were randomly recruited from Alexandra Health Clinic, Johannesburg, South Africa', 'people living with HIV']",['delayed centrifugation'],"['abnormal renal function', 'renal function', 'glomerular filtration rate', 'eGFR', 'enzymatic and i-STAT creatinine concentrations', 'Creatinine concentrations']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0007703', 'cui_str': 'Centrifugation'}]","[{'cui': 'C0151746', 'cui_str': 'Abnormal renal function'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0382562,The enzymatic and i-STAT creatinine concentrations were stable over 96 h viz.,"[{'ForeName': 'Chemedzai E', 'Initials': 'CE', 'LastName': 'Chikomba', 'Affiliation': 'Department of Chemical Pathology, National Health Laboratory Services, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Padoa', 'Affiliation': 'Department of Chemical Pathology, National Health Laboratory Services, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Tanyanyiwa', 'Affiliation': 'Department of Chemical Pathology, National Health Laboratory Service, Faculty of Health Science, Sefako Makgatho Health Sciences University, Pretoria, South Africa.'}]",Southern African journal of HIV medicine,['10.4102/sajhivmed.v21i1.1056']
2284,32832225,Microscope-integrated Intraoperative Optical Coherence Tomography for Anterior Segment Surgical Maneuvers.,"Purpose


To evaluate the potential value of microscope-integrated optical coherence tomography (MI-OCT) in anterior segment surgical maneuvers.
Methods


Twenty-four ophthalmology residents, who were randomly and evenly divided into two groups, performed four anterior segment surgical maneuvers (corneal tunnel, scleral tunnel, simple corneal suture, and corneal laceration repair) on porcine eyes with (group B) or without (group A) real-time MI-OCT feedback. All residents performed the maneuvers again without MI-OCT.
Results


Compared with group A, group B (with MI-OCT) showed better accuracy in the length/depth of the corneal tunnel and the length of the scleral tunnel. However, both groups showed similar performances in the depth of both the simple corneal suture and the corneal laceration suture. When both groups performed the maneuvers again without MI-OCT, group B still showed better results than group A for the length of both the corneal and scleral tunnels.
Conclusions


Primary results suggest that real-time MI-OCT images are valuable for some anterior segment surgical maneuvers and could be helpful in surgical training.
Translational Relevance


MI-OCT systems can be valuable in improving accuracy and decision making during anterior segment surgery and will be useful in surgical training.",2020,"When both groups performed the maneuvers again without MI-OCT, group B still showed better results than group A for the length of both the corneal and scleral tunnels.
",['Methods\n\n\nTwenty-four ophthalmology residents'],"['Microscope-integrated Intraoperative Optical Coherence Tomography', 'microscope-integrated optical coherence tomography (MI-OCT', 'anterior segment surgical maneuvers (corneal tunnel, scleral tunnel, simple corneal suture, and corneal laceration repair) on porcine eyes with (group B) or without (group A) real-time MI-OCT feedback']",['length/depth of the corneal tunnel and the length of the scleral tunnel'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0197454', 'cui_str': 'Suture of cornea'}, {'cui': 'C3515464', 'cui_str': 'Repair of laceration of cornea'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}]",,0.0111951,"When both groups performed the maneuvers again without MI-OCT, group B still showed better results than group A for the length of both the corneal and scleral tunnels.
","[{'ForeName': 'Wangyi', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Fudan University, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Qingchen', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Fudan University, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': 'Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Fudan University, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Fudan University, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zong', 'Affiliation': ""Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Fudan University, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Fudan University, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Xinghuai', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Fudan University, Shanghai, 200031, People's Republic of China.""}]",Translational vision science & technology,['10.1167/tvst.9.7.18']
2285,32832361,Oxytocin Differentially Modulates Amygdala Responses during Top-Down and Bottom-Up Aversive Anticipation.,"The ability to successfully regulate negative emotions such as fear and anxiety is vital for mental health. Intranasal administration of the neuropeptide oxytocin (OXT) has been shown to reduce amygdala activity but to increase amygdala-prefrontal cortex connectivity during exposure to threatening stimuli suggesting that it may act as an important modulator of emotion regulation. The present randomized, between-subject, placebo-controlled pharmacological study combines the intranasal administration of OXT with functional magnetic resonance imaging (fMRI) during an explicit emotion regulation paradigm in 65 healthy male participants to investigate the modulatory effects of OXT on both bottom-up and top-down emotion regulation. OXT attenuates the activation in the posterior insular cortex and amygdala during anticipation of top-down regulation of predictable threat stimuli in participants with high trait anxiety. In contrast, OXT enhances amygdala activity during the bottom-up anticipation of unpredictable threat stimuli in participants with low trait anxiety. OXT may facilitate top-down goal-directed attention by attenuating amygdala activity in high anxiety individuals, while promoting bottom-up attention/vigilance to unexpected threats by enhancing amygdala activity in low anxiety individuals. OXT may thus have the potential to promote an adaptive balance between bottom-up and top-down attention systems depending on an individual's trait anxiety level.",2020,OXT attenuates the activation in the posterior insular cortex and amygdala during anticipation of top-down regulation of predictable threat stimuli in participants with high trait anxiety.,"['participants with high trait anxiety', 'participants with low trait anxiety', '65 healthy male participants']","['OXT', 'placebo', 'neuropeptide oxytocin (OXT', 'Oxytocin', 'OXT with functional magnetic resonance imaging (fMRI']",['amygdala activity'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",65.0,0.0566987,OXT attenuates the activation in the posterior insular cortex and amygdala during anticipation of top-down regulation of predictable threat stimuli in participants with high trait anxiety.,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}, {'ForeName': 'Debo', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}, {'ForeName': 'Zhongbo', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Key Laboratory of Cognition and Personality Ministry of Education, Faculty of Psychology Southwest University Tiansheng Road 2 Chongqing 400715 China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}, {'ForeName': 'Antao', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality Ministry of Education, Faculty of Psychology Southwest University Tiansheng Road 2 Chongqing 400715 China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute MOE Key Laboratory for Neuroinformation University of Electronic Science and Technology of China Xiyuan Avenue 2006 Chengdu 611731 China.'}]","Advanced science (Weinheim, Baden-Wurttemberg, Germany)",['10.1002/advs.202001077']
2286,32832375,Don't Tell Me What to Think: Comparing Self- and Other-Generated Distraction Methods for Controlling Intrusive Thinking.,"Cognitive control is central to the phenomenon of intrusive thinking in obsessive-compulsive and related disorders. The current study tested how attempts at cognitive control are impacted by self- vs. other-generated distractor thoughts. Participants ( N =1913) were randomly assigned to suppress or monitor an intrusive thought and also randomly assigned to: a) self-generate a distractor, b) receive a distractor, or c) receive no distractor guidance. Participants reported subsequent thought recurrences, perceived success and effort keeping the thought out of mind, and positive and negative affect during a one-minute thinking period and a one-minute monitoring period. During the first thinking period only, self-generated distractors resulted in greater perceived control ( p <.001; during monitoring instructions only) relative to no guidance, and less effort ( p s<.001) relative to both other conditions. Interestingly, self-generated distractors led to longer duration of recurrences relative to both other conditions ( p s≤.007). Finally, there were no distractor differences in trajectories of positive and negative affect ( p s>.10). These findings suggest that the source of distractors may inform when attempts to control intrusive thinking will be helpful versus harmful.",2019,"During the first thinking period only, self-generated distractors resulted in greater perceived control ( p <.001; during monitoring instructions only) relative to no guidance, and less effort ( p s<.001) relative to both other conditions.",['Participants ( N =1913'],"['self-generate a distractor, b) receive a distractor, or c) receive no distractor guidance']",[],[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]",[],1913.0,0.0355119,"During the first thinking period only, self-generated distractors resulted in greater perceived control ( p <.001; during monitoring instructions only) relative to no guidance, and less effort ( p s<.001) relative to both other conditions.","[{'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Magee', 'Affiliation': 'Miami University, 90 North Patterson Ave., Oxford, OH 45056.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Dreyer-Oren', 'Affiliation': 'Miami University, 90 North Patterson Ave., Oxford, OH 45056.'}, {'ForeName': 'Laurel D', 'Initials': 'LD', 'LastName': 'Sarfan', 'Affiliation': 'Miami University, 90 North Patterson Ave., Oxford, OH 45056.'}, {'ForeName': 'Bethany A', 'Initials': 'BA', 'LastName': 'Teachman', 'Affiliation': 'University of Virginia, Department of Psychology, 102 Gilmer Hall, P.O. Box 400400 Charlottesville, VA 22904-4400.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Clerkin', 'Affiliation': 'Miami University, 90 North Patterson Ave., Oxford, OH 45056.'}]",Journal of obsessive-compulsive and related disorders,['10.1016/j.jocrd.2017.12.003']
2287,32832442,"A Study to Evaluate the Role of Intradermal and Intralesional Measles, Mumps, Rubella (MMR) Vaccine in Treatment of Common Warts.","Background


Warts are common cutaneous viral infection with a wide range of therapeutic modalities. Various agents have been tried for immunotherapy in warts.
Objectives


Determine the role of intralesional and intradermal measles, mumps, rubella (MMR) vaccine in the treatment of common warts; to compare the efficacy of intralesional versus intradermal MMR vaccine.
Methods and Materials


Patients diagnosed with verruca vulgaris were divided into two groups. In study group A, the individuals were injected with an intralesional MMR vaccine of 0.3 mL in the representative wart (largest) once in 3 weeks till there is complete clearance or maximum of four injections whichever is earlier, while in study group B, the individuals were injected with an intradermal MMR vaccine of 0.3 mL over the unilateral deltoid muscle area at similar intervals.
Results


There were 33 patients in each group. In group A, 10 (30.3%) patients showed complete, 9 (27.3%) marked, 6 (18.2%) moderate, 3 (9.1%) mild, and 5 (15.2%) no response. In group B, seven (21.2%) patients showed complete, one (3.0%) marked, one (3.0%) moderate, four (12.1%) mild, and 20 (60.6%) no response. There were minimal side effects in the form of pain, erythema, itching at the injection site in a few patients, only one patient had syncope.
Conclusion


We conclude that the MMR vaccine is an effective and safe modality of treatment for verruca vulgaris without any serious adverse effects. Also, the intralesional route showed better results in comparison to the intradermal route when we consider the treatment of a representative wart.",2020,"There were minimal side effects in the form of pain, erythema, itching at the injection site in a few patients, only one patient had syncope.
","['common warts', 'Patients diagnosed with verruca vulgaris']","['intradermal MMR vaccine of 0.3 mL over the unilateral deltoid muscle area at similar intervals', 'intralesional versus intradermal MMR vaccine', 'Intradermal and Intralesional Measles, Mumps, Rubella (MMR) Vaccine', 'intralesional MMR vaccine', 'MMR vaccine', 'intralesional and intradermal measles, mumps, rubella (MMR) vaccine']","['pain, erythema, itching', 'syncope']","[{'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0035920', 'cui_str': 'Rubella'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}]",33.0,0.0358487,"There were minimal side effects in the form of pain, erythema, itching at the injection site in a few patients, only one patient had syncope.
","[{'ForeName': 'Pragya', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, IGMC Shimla, District Sirmour, Himachal Pradesh, India.'}, {'ForeName': 'Geeta Ram', 'Initials': 'GR', 'LastName': 'Tegta', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, IGMC Shimla, District Sirmour, Himachal Pradesh, India.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Verma', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, IGMC Shimla, District Sirmour, Himachal Pradesh, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, IGMC Shimla, District Sirmour, Himachal Pradesh, India.'}, {'ForeName': 'Mudita', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, IGMC Shimla, District Sirmour, Himachal Pradesh, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, IGMC Shimla, District Sirmour, Himachal Pradesh, India.'}]",Indian dermatology online journal,['10.4103/idoj.IDOJ_144_19']
2288,32832533,Acute effects of supplemental oxygen therapy using different nasal cannulas on walking capacity in patients with idiopathic pulmonary fibrosis: a randomised crossover trial.,"Something simple, like changing a nasal cannula for a technologically superior one, can improve exercise capacity and oxygenation in patients with IPF. There is a need to develop improved cannulas for comfort and patient acceptance.  https://bit.ly/2NelacE.",2020,"Something simple, like changing a nasal cannula for a technologically superior one, can improve exercise capacity and oxygenation in patients with IPF.","['patients with IPF', 'patients with idiopathic pulmonary fibrosis']",['supplemental oxygen therapy'],"['walking capacity', 'exercise capacity and oxygenation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",,0.0479081,"Something simple, like changing a nasal cannula for a technologically superior one, can improve exercise capacity and oxygenation in patients with IPF.","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Dept of Pulmonary Rehabilitation, Philipps-University of Marburg, German Centre for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Leitl', 'Affiliation': 'Dept of Pulmonary Rehabilitation, Philipps-University of Marburg, German Centre for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Gloeckl', 'Affiliation': 'Dept of Pulmonary Rehabilitation, Philipps-University of Marburg, German Centre for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Dept of Pulmonary Rehabilitation, Philipps-University of Marburg, German Centre for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Reimann', 'Affiliation': 'Dept of Internal Medicine, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hitzl', 'Affiliation': 'Research Office (Biostatistics), Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Rembert', 'Initials': 'R', 'LastName': 'Koczulla', 'Affiliation': 'Dept of Pulmonary Rehabilitation, Philipps-University of Marburg, German Centre for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kenn', 'Affiliation': 'Dept of Pulmonary Rehabilitation, Philipps-University of Marburg, German Centre for Lung Research (DZL), Marburg, Germany.'}]",ERJ open research,['10.1183/23120541.00197-2020']
2289,32832583,Community case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trial.,"Background


The World Health Organization (WHO) integrated management of childhood illness (IMCI) protocol recommends treatment of chest indrawing in 2-59 months old children with oral amoxicillin by trained health facility workers. Whereas, the WHO/UNICEF integrated community case management (iCCM) protocol recommends referral by community level health workers (CLHWs) to a health facility. This study aims to evaluate whether CLHWs can treat chest indrawing pneumonia effectively and safely.
Methods


This multi-centre cluster randomized controlled open label, non-inferiority trial will be conducted in Bangladesh, Ethiopia, India and Malawi. All sites will use a common protocol with the same study design, participants, intervention, control and outcomes. CLHWs will identify 2-59 months old children with chest indrawing. Study supervisors, trained in the iCCM protocol, will confirm CLHWs' findings. Pulse oximetry will be used to identify hypoxaemic children. In the intervention group, enrolled children will be treated with oral amoxicillin for 5 days, and in the control group they will be referred to a health facility, after providing first dose of oral amoxicillin. An independent outcome assessor will visit each enrolled child on days 6 and 14 of enrolment, to assess study outcomes.
Conclusions


If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible. Moreover, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with the IMCI protocol.
Trial Registration


The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.",2020,"Conclusions


If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible.","['children aged 2 to 59 months by community health workers', 'chest indrawing in 2-59 months old children with oral amoxicillin by trained health facility workers', 'hypoxaemic children']","['oral amoxicillin', 'CLHWs', 'amoxicillin']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],,0.151848,"Conclusions


If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical trials,['10.18203/2349-3259.ijct20201719']
2290,32832625,A customized belonging intervention improves retention of socially disadvantaged students at a broad-access university.,"Broad-access institutions play a democratizing role in American society, opening doors to many who might not otherwise pursue college. Yet these institutions struggle with persistence and completion. Do feelings of nonbelonging play a role, particularly for students from groups historically disadvantaged in higher education? Is belonging relevant to students' persistence-even when they form the numerical majority, as at many broad-access institutions? We evaluated a randomized intervention aimed at bolstering first-year students' sense of belonging at a broad-access university ( N  = 1,063). The intervention increased the likelihood that racial-ethnic minority and first-generation students maintained continuous enrollment over the next two academic years relative to multiple control groups. This two-year gain in persistence was mediated by greater feelings of social and academic fit one-year post-intervention. Results suggest that efforts to address belonging concerns at broad-access, majority-minority institutions can improve core academic outcomes for historically disadvantaged students at institutions designed to increase college accessibility.",2020,This two-year gain in persistence was mediated by greater feelings of social and academic fit one-year post-intervention.,['socially disadvantaged students at a broad-access university'],[],[],"[{'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],[],,0.0207926,This two-year gain in persistence was mediated by greater feelings of social and academic fit one-year post-intervention.,"[{'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Murphy', 'Affiliation': 'Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Maithreyi', 'Initials': 'M', 'LastName': 'Gopalan', 'Affiliation': 'Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Evelyn R', 'Initials': 'ER', 'LastName': 'Carter', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Katherine T U', 'Initials': 'KTU', 'LastName': 'Emerson', 'Affiliation': 'Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Bette L', 'Initials': 'BL', 'LastName': 'Bottoms', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Walton', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}]",Science advances,['10.1126/sciadv.aba4677']
2291,32832978,"Fremanezumab: a disease-specific option for the preventive treatment of migraine, including difficult-to-treat migraine.","Fremanezumab is a fully humanized monoclonal antibody (IgG2Δa) that targets calcitonin gene-related peptide (CGRP), a key neuropeptide involved in the pathophysiology of migraine. Fremanezumab is approved for quarterly and monthly subcutaneous dosing for the preventive treatment of migraine in adults. The phase 3 clinical development program for fremanezumab aimed to evaluate the efficacy of this preventive treatment across different patient populations, including those with difficult-to-treat migraine. Two pivotal 12-week, phase 3, placebo-controlled studies investigated quarterly and monthly dosing of fremanezumab in participants with chronic migraine (HALO CM) and episodic migraine (HALO EM). The efficacy of fremanezumab was further explored in individuals with difficult-to-treat chronic or episodic migraine in the 12-week FOCUS study, which enrolled participants who had previously experienced an inadequate response to 2-4 pharmacological classes of migraine preventive medications. The long-term efficacy of fremanezumab was assessed in a 12-month long-term study (HALO LTS), which enrolled participants completing the 12-week HALO studies and new participants. Across these studies, treatment with fremanezumab dosed quarterly or monthly provided significant reductions in the frequency of migraine days, headache days of at least moderate severity, and migraine- and headache-related disability compared with placebo. Sustained improvements were seen with long-term fremanezumab treatment. Subgroup analyses of participants with difficult-to-treat migraine (those with comorbid depression, overuse of acute headache medications, and concomitant use of other migraine preventive medications) demonstrated the effectiveness of quarterly or monthly fremanezumab in these populations. Ongoing studies are further exploring the potential benefits of fremanezumab in difficult-to-treat migraine and other headache and pain disorders.",2020,"Fremanezumab is a fully humanized monoclonal antibody (IgG2Δa) that targets calcitonin gene-related peptide (CGRP), a key neuropeptide involved in the pathophysiology of migraine.","['participants with difficult-to-treat migraine (those with comorbid depression, overuse of acute headache medications, and concomitant use of other migraine preventive medications', 'migraine in adults', 'individuals with difficult-to-treat chronic or episodic migraine in the 12-week FOCUS study, which enrolled participants who had previously experienced an inadequate response to 2-4 pharmacological classes of migraine preventive medications', 'participants with chronic migraine (HALO CM) and episodic migraine (HALO EM', 'enrolled participants completing the 12-week HALO studies and new participants']","['Fremanezumab', 'placebo', 'fremanezumab']","['frequency of migraine days, headache days of at least moderate severity, and migraine- and headache-related disability']","[{'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0477373', 'cui_str': 'Other migraine'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0209867,"Fremanezumab is a fully humanized monoclonal antibody (IgG2Δa) that targets calcitonin gene-related peptide (CGRP), a key neuropeptide involved in the pathophysiology of migraine.","[{'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': 'Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, U.S.A.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, U.S.A.'}]",Emerging topics in life sciences,['10.1042/ETLS20200018']
2292,32842367,[Inner hair cells loss by carboplatin and the changes of cochlear compound action potential in chinchillas].,"Objective:  To measure the cochlear compound action potential (CAP) and the densities of hair cells (HCs) along the whole length of the basilar membrane (BM) in adult chinchillas. And to investigate the relationship between the severity of inner hair cells (IHCs) loss and the changes of CAP by using carboplatin-cochlear lesion model.  Methods:  Totally 18 chinchillas were recruited after ontological evaluation. They were randomly divided into three groups (with 6 subjects in each), A: control, B and C: legion groups treated with one or two shot(s) of carboplatin respectively (76 mg/kg in one shot, i.p., one-week interval between the two shots). Endpoint tests were performed 30 days after the carboplatin treatment in groups B and C, and matched time in group A. A sliver-ball electrode was placed into round window niche via hypotympanic approach in anesthetized chinchilla. CAP was measured in response to clicks and tone burst of 0.5, 1, 2, 4, 8, 16 kHz respectively under anesthesia. CAP amplitudes and thresholds were measured and compared across the groups. After the recording, the whole cochlea surface preparation was made and the HCs were stained in histochemistry against substrate of succinate dehydrogenase (SDH). Images were taken with high-resolution digital camera under light microscope and across the whole cochlea. The length of the basilar membrane (BM) and the number of both IHCs and OHCs were counted. The HC density was calculated as the number of HCs per 10% BM length.  Results:  The CAP thresholds were (7.1±2.6), (25.4±5.0), (24.6±5.4), (10.4±5.0), (0.4±1.4), (4.2±6.3) and (17.1±14.1) dB SPL (from 6 subjects in group A,  n= 12 ears) corresponding to stimuli of Click and 0.5, 1, 2, 4, 8, 16 kHz tone bursts respectively. The total number of cochlear HCs were measured as (8 936±643) ( x ± s ) and the average length of the BMs was (17.73±1.012) mm from the six subjects in the group A ( n= 12 ears). The HC density was found to be varied slightly across the BM. There was no significant CAP threshold difference between the control (group A) and the group B, which received one shot of carboplatin. However, the maximal CAP amplitude was reduced by 40% in the group B and compared with group A. Correspondingly, approximately 40% loss of IHCs were seen. In contrast, a significant CAP threshold shift was seen in subjects receiving two shots of carboplatin (group C), which was accompanied by a loss of 90% IHCs.  Conclusions:  The CAP thresholds of adult chinchillas show typical open-V shape with the lowest values at 2, 4, and 8 kHz. IHC loss by carboplatin in certain degree is well correlated with CAP amplitude reduction, but does not change the threshold when inner hair cell loss reaches 40%, however, if inner hair cell loss exceeds 80%, the threshold shift of CAP will be inevitable.",2020,"There was no significant CAP threshold difference between the control (group A) and the group B, which received one shot of carboplatin.",['Methods:  Totally 18 chinchillas were recruited after ontological evaluation'],['carboplatin'],"['average length of the BMs', 'length of the basilar membrane (BM) and the number of both IHCs and OHCs', 'IHC loss', 'severity of inner hair cells (IHCs) loss', 'HC density', 'cochlear compound action potential (CAP) and the densities of hair cells (HCs', 'total number of cochlear HCs', 'CAP amplitudes and thresholds', 'CAP', 'maximal CAP amplitude', 'CAP threshold shift']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008119', 'cui_str': 'Genus Chinchilla'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0004816', 'cui_str': 'Structure of basilar membrane of cochlea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018497', 'cui_str': 'Inner hair cell'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0009195', 'cui_str': 'Cochlear structure'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0018496', 'cui_str': 'Hair cell'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",18.0,0.0342169,"There was no significant CAP threshold difference between the control (group A) and the group B, which received one shot of carboplatin.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Ding', 'Affiliation': ""Center for Hearing and Deafness, Department of Communicative Disorders and Sciences, State University of New York at Buffalo. Buffalo, NY 14214, USA; Department of Otorhinolaryngology Head and Neck Surgery, Affiliated Sixth People's Hospital of Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Affiliated Sixth People's Hospital of Shanghai Jiaotong University, Shanghai 200233, China; School of Human Communication Disorders, Dalhousie University, Halifax, NS 250101, Canada.""}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Cao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Salvi', 'Affiliation': 'Center for Hearing and Deafness, Department of Communicative Disorders and Sciences, State University of New York at Buffalo. Buffalo, NY 14214, USA.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Qi', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}]",Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery,['10.3760/cma.j.cn.115330-20200426-00332']
2293,32842399,[Clinical effects of vacuum sealing drainage in the treatment of alkali burn wounds].,"Objective:  To preliminarily observe the clinical effects of vacuum sealing drainage (VSD) in the treatment of alkali burn wounds.  Methods:  From June 2016 to March 2020, 60 male patients with alkali burns who met the inclusion criteria and hospitalized in the Affiliated Hospital of Jiangnan University were recruited in this prospectively randomized control study. According to the random number table, silver sulfadiazine group and VSD group were both allocated with 30 patients, aged (36±8) and (35±10) years respectively; with total burn area of (7.2±2.0) % and (8.5±3.0) % total body surface area respectively. After admission, patients in silver sulfadiazine group were treated with conventional silver sulfadiazine dressing change once a day after debridement; patients in VSD group were given continuous VSD treatment after debridement, with the negative pressure setting at -10.67 kPa, and the negative pressure materials were replaced every 6 to 8 days. On treatment day 1, 4, and 7, the exudate from the wounds of patients in silver sulfadiazine group and the wound drainage fluid of patients in VSD group were collected, the pH value was measured by a portable pH meter, and the volume of exudate/drainage fluid was measured. After 7, 14, and 21 days of treatment, the wound healing rates of patients were calculated in the two groups. Before treatment and 7 days after treatment, venous blood was collected from the patients in the two groups to detect the serum level of tumor necrosis factor α (TNF-α) and interleukin 8 (IL-8). Within treatment day 14, Visual Analogue Scale was used to assess the pain score of patients in the two groups during each time of dressing change. The medical costs and discharge satisfaction scores of patients in the two groups were recorded. Data were statistically analyzed with analysis of variance for repeated measurement,  t  test, and Bonferroni correction.  Results:  (1) On treatment day 1, 4, and 7, the pH values of the drainage fluid of patients in VSD group were 9.75±0.59, 9.01±0.46, and 8.13±0.28, respectively, which were significantly higher than 9.35±0.62, 8.18±0.18, and 7.58±0.09 of exudate of patients in silver sulfadiazine group ( t =2.03, 6.80, 7.56,  P <0.05 or  P <0.01). On treatment day 1 and 4, the volumes of drainage fluid of patients in VSD group were (553±83) and (239±65) mL respectively, which were significantly higher than (440±77) and (175±49) mL of exudate of patients in silver sulfadiazine group ( t =3.44, 2.24,  P <0.05). On treatment day 7, the volume of drainage fluid of patients in VSD group was (21±8) mL, which was significantly lower than (149±44) mL of exudate of patients in silver sulfadiazine group ( t =-12.61,  P <0.01). (2) After 7, 14, and 21 days of treatment, the wound healing rates of patients in VSD group were (39±6) %, (74±10) %, and (92±3) %, respectively, which were significantly higher than (25±3) %, (59±6) %, and (77±6) % in silver sulfadiazine group ( t =7.07, 5.59, 7.09,  P <0.01). (3) Before treatment, the serum levels of TNF-α and IL-8 of patients in the two groups were similar. After 7 days of treatment, the serum levels of TNF-α and IL-8 of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-8.75, -8.04,  P <0.01). (4) The pain score during dressing change and medical cost of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-4.28, -7.56,  P <0.01), while the discharge satisfaction score of patients in VSD group was significantly higher than that in silver sulfadiazine group ( t =10.91,  P <0.05).  Conclusions:  The application of VSD technology in clinical alkali burn wounds can effectively promote the removal of residual lye, alleviate the further damage of lye to skin tissue, shorten the wound healing time, effectively remove inflammatory mediators, reduce the pain of dressing change, decrease the total cost of treatment, and enhance satisfaction of patient.",2020,"After 7 days of treatment, the serum levels of TNF-α and IL-8 of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-8.75, -8.04,  P <0.01).","['60 male patients with alkali burns who met the inclusion criteria and hospitalized in the Affiliated Hospital of Jiangnan University', 'alkali burn wounds']","['continuous VSD treatment', 'vacuum sealing drainage', 'conventional silver sulfadiazine', 'vacuum sealing drainage (VSD', 'silver sulfadiazine']","['venous blood', 'Visual Analogue Scale', 'serum levels of TNF-α and IL-8', 'serum level of tumor necrosis factor α (TNF-α) and interleukin 8 (IL-8', 'medical costs and discharge satisfaction scores', 'volume of drainage fluid', 'discharge satisfaction score', 'pain score', 'wound healing rates']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}]","[{'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",60.0,0.0278021,"After 7 days of treatment, the serum levels of TNF-α and IL-8 of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-8.75, -8.04,  P <0.01).","[{'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Huang', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Jia', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Gu', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'G Z', 'Initials': 'GZ', 'LastName': 'Lyu', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20200115-00024']
2294,32842451,[Influence of laparoscopic radical gastrectomy on immune function and coagulation function and prognosis].,"Objective:  To explore the influence of laparoscopic radical gastrectomy on patients'immune functions, coagulation functions and prognoses.  Methods:  Fifty-eight patients with gastric cancer who underwent laparoscopic radical gastrectomy (laparoscopic group) and 40 patients with gastric cancer who underwent traditional open surgery (traditional group) in Henan People's Hospital from May 2016 to May 2018 were selected as the subjects. The immune function and coagulation function were compared between the two groups before and after operation. The prognoses of patients underwent laparoscopic radical gastrectomy and the influencing factors were analyzed.  Results:  Three days after operation, the CD4(+) level and CD4(+) /CD8(+) ratio in laparoscopic group were (29.78±3.58)% and (1.01±0.18), higher than (27.23±3.47)% and (0.93±0.14) in control group ( P <0.05). Three days after operation, the activated partial thromboplastin time (APTT) in laparoscopic group was (26.55±2.56) seconds, shorter than (27.86±2.73) seconds in traditional group, while the levels of fibrinogen (FIB) and D-dimer were (4.24±0.84) g/L and (377.91±47.19) μg/L, higher than (3.88±0.75) g/L and (330.28±45.11) μg/L in traditional group ( P <0.05). The 5-year survival rate was 77.5% in traditional group and 72.4% in laparoscopic group, without significant difference ( P >0.05). Multivariate analysis showed that lymph node metastasis was the independent risk factor for prognosis of laparoscopic radical gastrectomy ( P <0.05).  Conclusions:  Laparoscopic radical gastrectomy can effectively reduce postoperative immunosuppression, but affect postoperative coagulation function. Lymph node metastasis is closely related to the prognosis of patient with gastric cancer. The patient's condition should be comprehensively evaluated before and after operation to determine whether the laparoscopic operation is suitable, for reducing postoperative complications and improving the prognosis.",2020,Multivariate analysis showed that lymph node metastasis was the independent risk factor for prognosis of laparoscopic radical gastrectomy ( P <0.05).  ,"[""40 patients with gastric cancer who underwent traditional open surgery (traditional group) in Henan People's Hospital from May 2016 to May 2018 were selected as the subjects"", 'Fifty-eight patients with gastric cancer who underwent']","['Laparoscopic radical gastrectomy', 'CD8', 'laparoscopic radical gastrectomy (laparoscopic group', 'laparoscopic radical gastrectomy']","['immune function and coagulation function and prognosis', 'levels of fibrinogen (FIB) and D-dimer', ""patients'immune functions, coagulation functions and prognoses"", 'activated partial thromboplastin time (APTT', 'CD4(+) level and CD4', '5-year survival rate', 'immune function and coagulation function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",58.0,0.0291244,Multivariate analysis showed that lymph node metastasis was the independent risk factor for prognosis of laparoscopic radical gastrectomy ( P <0.05).  ,"[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Gu', 'Affiliation': ""Department of Gastrointestinal Surgery, People's Hospital of Zhengzhou University, Henan People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Bao', 'Affiliation': ""Department of Gastrointestinal Surgery, People's Hospital of Zhengzhou University, Henan People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': ""Department of Gastrointestinal Surgery, People's Hospital of Zhengzhou University, Henan People's Hospital, Zhengzhou 450000, China.""}]",Zhonghua zhong liu za zhi [Chinese journal of oncology],['10.3760/cma.j.cn112152-20190731-00482']
2295,32831509,Clinical and microbiological effects of 1%  Matricaria chamomilla  mouth rinse on chronic periodontitis: A double-blind randomized placebo controlled trial.,"Background


Several herbal mouth rinses are assessed in the literature as an adjunct to scaling and root planning (SRP) for the treatment of periodontal diseases. The objective of this study was to evaluate and compare the clinical and microbiological effects of  Matricaria chamomilla  (MTC) mouth rinse with chlorhexidine (CHX) and placebo mouth rinse for the management of chronic periodontitis.
Materials and Methods


This double-blind, randomized, placebo controlled, clinical trial involved seventy five patients, suffering from chronic periodontitis, which were randomly divided into three groups: negative control (SRP + placebo), positive control (SRP + 0.12% CHX), and test group (SRP + 1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month while clinical parameters (plaque index, gingival index, sulcus bleeding index, probing pocket depth [PPD], clinical attachment level, gingival recession [GR], stain index) and microbial colony forming units were evaluated at base line, 6 weeks, and 3 months.
Results


All groups showed a significant change in parameters (except GR for placebo group) between base line and 3 months. MTC mouth rinse suggested added significant benefits over placebo group over the study period. However, it determined more but nonsignificant improvement in PPD (3.68 mm vs. 3.36 mm) and CAL (3.00 mm vs. 2.72 mm) as compared to CHX rinse at 3 months' period as compared to baseline.
Conclusion


Advantages of using test group were comparable to CHX associated group; therefore, MTC mouth rinse can be used as an effective adjunct during nonsurgical periodontal therapy for chronic periodontitis.",2020,"However, it determined more but nonsignificant improvement in PPD (3.68 mm vs. 3.36 mm) and CAL (3.00 mm vs. 2.72 mm) as compared to CHX rinse at 3 months' period as compared to baseline.
","['chronic periodontitis', 'seventy five patients, suffering from chronic periodontitis']","['negative control (SRP + placebo), positive control (SRP + 0.12% CHX), and test group (SRP + 1% MTC mouth rinse', 'placebo', 'Matricaria chamomilla  mouth rinse', 'Matricaria chamomilla  (MTC) mouth rinse with chlorhexidine (CHX) and placebo mouth rinse', 'Mouth rinsing (adjunctive therapy']","['PPD', 'clinical parameters (plaque index, gingival index, sulcus bleeding index, probing pocket depth [PPD], clinical attachment level, gingival recession [GR], stain index) and microbial colony forming units']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0939806', 'cui_str': 'Matricaria recutita extract'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",75.0,0.540235,"However, it determined more but nonsignificant improvement in PPD (3.68 mm vs. 3.36 mm) and CAL (3.00 mm vs. 2.72 mm) as compared to CHX rinse at 3 months' period as compared to baseline.
","[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Periodontics, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Periodontics, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_441_19']
2296,32831508,Evaluation of the efficacy of subgingival irrigation in patients with moderate-to-severe chronic periodontitis otherwise indicated for periodontal flap surgeries.,"Background


In certain medically and physically compromised; and terminally ill patients, periodontal surgery may not be feasible. They need special attention and assistance for their daily plaque control regimens for the management and maintenance of periodontal conditions. Subgingival irrigation home care devices with antiplaque agents may serve as useful tools in such specific patient populations.
Aims


The aim of this study was to evaluate of the efficacy of sub-gingival irrigation in patients with moderate-to-severe chronic periodontitis otherwise indicated for periodontal flap surgeries.
Settings and Design


Randomized comparative parallel group interventional clinical trial.
Materials and Methods


Forty adults with moderate-to-severe periodontitis, divided inot Group A and B, were subjected to the use of subgingival home irrigations using 0.06% chlorhexidine (CHX) and mouth-rinsing with 15 ml of 0.12% CHX twice daily, respectively after Phase I therapy. Clinical parameters, i.e., gingival index, oral hygiene index simplified, and bleeding on probing scores were assessed at baseline, 2 weeks, 4 weeks, and 12 weeks' postphase I therapy, whereas clinical attachment level (CAL), probing depth (PD), and stain assessment at baseline and 12 weeks following Phase I therapy.
Statistical Analysis Used


Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, USA version 15.0 for Windows).
Results


A statistically significant difference was seen with the use of 0.06% CHX irrigations in PD ( P  = 0.004) and CAL ( P  = 0.002) as compared to the use of mouth rinsing with 0.12% CHX. Similar differences were observed in both intensity ( P  = 0.014) and area ( P  = 0.034) of lingual surface staining with greater staining with CHX mouth rinsing.
Conclusion


The adjunctive use of subgingival home irrigations using 0.06% CHX has a promising potential to maintain the oral health and results in lesser staining compared to CHX mouth rinsing. The regimen may further obviate the need of periodontal surgery in medically compromised subjects.",2020,"Similar differences were observed in both intensity ( P  = 0.014) and area ( P  = 0.034) of lingual surface staining with greater staining with CHX mouth rinsing.
","['patients with moderate-to-severe chronic periodontitis otherwise indicated for periodontal flap surgeries', 'Forty adults with moderate-to-severe periodontitis']","['sub-gingival irrigation', 'subgingival irrigation', 'subgingival home irrigations using 0.06% chlorhexidine (CHX) and mouth-rinsing with 15 ml of 0.12% CHX']","['clinical attachment level (CAL), probing depth (PD), and stain assessment', 'gingival index, oral hygiene index simplified, and bleeding on probing scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C4517426', 'cui_str': '0.12'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0702022,"Similar differences were observed in both intensity ( P  = 0.014) and area ( P  = 0.034) of lingual surface staining with greater staining with CHX mouth rinsing.
","[{'ForeName': 'Rajni', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Periodontology, Dr. HS Judge Institute of Dental Sciences and Hospital, Punjab University, Chandigarh, India.'}, {'ForeName': 'Rashi', 'Initials': 'R', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Periodontology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Nymphea', 'Initials': 'N', 'LastName': 'Pandit', 'Affiliation': 'Department of Periodontology, DAV Dental College, Yamunanagar, Haryana, India.'}, {'ForeName': 'Vishakha', 'Initials': 'V', 'LastName': 'Grover', 'Affiliation': 'Department of Periodontology, Dr. HS Judge Institute of Dental Sciences and Hospital, Punjab University, Chandigarh, India.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Lyle', 'Affiliation': 'Water Pik Inc., Fort Collins, CO, USA.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Periodontology, Dr. HS Judge Institute of Dental Sciences and Hospital, Punjab University, Chandigarh, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_54_20']
2297,32831510,A comparative evaluation of manual and powered brushing on oral health and microbial status of mentally challenged individuals.,"Background


Tooth brushing is a very simple and effective method for removing daily dental deposits and for preventing dental and periodontal diseases. In physically or mentally challenged person, there arises difficulty in oral hygiene maintenance so that oral hygiene methods may need to be simplified or modified to suit the individual situation.
Methodology


Thirty individuals of age group 15-30 years with mild to moderate degree of mental retardation were selected. A randomized double-blind split-mouth design with Clinical Phase-i (aided brushing) and Clinical Phase-ii (unaided brushing) with a washout period of 3 days was conducted. The study duration was for 0-45 days. Two types of brushing that is manual and powered brushing were done. The recording of all clinical and microbial parameters were done on 0 th  day and 21 st  day while the clinical parameters were recorded up to 45 th  day.
Results


On intragroup comparison, throughout the study phases, both manual and powered brushing significantly reduced the Quigley-Hein plaque index (48%), gingival bleeding index (GBI) (44%), and modified gingival index (52%). The Pearson correlation between GBI and periodontal pathogens like Prevotella internedia,  Porphyromonas gingivalis , and  Fusobacterium nucleatum  showed statistically significant relation ( P  < 0.05) in powered brushing group.
Conclusion


Powered toothbrush was more effective than manual toothbrush in reducing plaque levels and microbial count in the mentally challenged individuals. The Colgate 360 tooth brush is advisable to mentally challenged individuals.",2020,"On intragroup comparison, throughout the study phases, both manual and powered brushing significantly reduced the Quigley-Hein plaque index (48%), gingival bleeding index (GBI) (44%), and modified gingival index (52%).","['Methodology\n\n\nThirty individuals of age group 15-30 years with mild to moderate degree of mental retardation were selected', 'mentally challenged individuals']","['manual toothbrush', 'Clinical Phase-i (aided brushing) and Clinical Phase-ii (unaided brushing', 'manual and powered brushing']","['plaque levels and microbial count', 'Quigley-Hein plaque index', 'gingival bleeding index (GBI', 'modified gingival index']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020796', 'cui_str': 'Profound intellectual disability'}]","[{'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",,0.0223133,"On intragroup comparison, throughout the study phases, both manual and powered brushing significantly reduced the Quigley-Hein plaque index (48%), gingival bleeding index (GBI) (44%), and modified gingival index (52%).","[{'ForeName': 'Kharidi Laxman', 'Initials': 'KL', 'LastName': 'Vandana', 'Affiliation': 'Department of Periodontics, College of Dental Sciences, Davangere, Karnataka, India.'}, {'ForeName': 'Pramod Vinayak', 'Initials': 'PV', 'LastName': 'Tatuskar', 'Affiliation': 'Department of Periodontics, College of Dental Sciences, Davangere, Karnataka, India.'}, {'ForeName': 'Narayan Narendra', 'Initials': 'NN', 'LastName': 'Valavalkar', 'Affiliation': 'Department of Periodontics, College of Dental Sciences, Davangere, Karnataka, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_340_19']
2298,32836201,Development and validation of a nomogram for predicting survival of advanced breast cancer patients in China.,"BACKGROUND


There is a lack of prognostic models predicting the overall survival (OS) of advanced breast cancer (ABC) patients in China.
METHODS


Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants were enrolled in this study, which were further randomized 3:1 and divided into training (n = 1706) and validation (n = 557) groups. The nomogram was built based on independent predictors identified by univariate and multivariate cox regression analyses. The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
RESULTS


Univariate and multivariate analyses found that age, Eastern Cooperative Oncology Group (ECOG) score, T-stage, N-stage, tumor subtype, the presence of distant lymph node (DLN)/liver/brain metastasis, local therapy, efficacy of first-line therapy and metastatic-free interval (MFI) were significantly related to OS (all P < 0.05). These variables were incorporated into a nomogram to predict the 2-year and 3-year OS of ABC patients. The C-indexes of the nomogram were 0.700 (95% confidence interval [CI]: 0.683-0.717) for the training set and 0.686 (95% CI: 0.652-0.719) for the validation set. The calibration curves revealed satisfactory consistency between actual survival and nomogram prediction in both the internal and external validations. The nomogram was capable of stratifying patients into different risk cohorts.
CONCLUSIONS


We constructed and validated a nomogram that might serve as an efficient tool to provide prognostic prediction for ABC patients and guide the physicians to make personalized treatment decisions.",2020,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","['advanced breast cancer patients in China', 'Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants', 'advanced breast cancer (ABC) patients in China']",[],['overall survival (OS'],"[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0456591', 'cui_str': '1987'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",4039.0,0.0279926,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","[{'ForeName': 'Shaoyan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Hongnan', 'Initials': 'H', 'LastName': 'Mo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China. Electronic address: xubinghe@medmail.com.cn.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.004']
2299,32836563,Reframing Time Spent Alone: Reappraisal Buffers the Emotional Effects of Isolation.,"Background


Loneliness, a transdiagnostic feature of psychopathology, is an experience of perceived isolation only weakly linked to the amount of time spent alone. Although traditional loneliness interventions aim to increase social contact, targeting maladaptive cognition about time alone may be an effective way to reduce loneliness. We investigated whether a brief reappraisal manipulation enables individuals to experience their time alone more positively. We also tested the impact of trait loneliness, compulsive social media use, and trait reappraisal on experiences of time alone.
Methods


College students and community members ( N  = 220) were randomly assigned to read a passage about the benefits of solitude ( n  = 74), the true prevalence of loneliness ( n  = 72), or a control topic ( n  = 74). Participants then sat alone for 10 min.
Results


Across conditions, positive and negative mood significantly decreased after sitting alone. Participants who read about the benefits of solitude experienced a smaller reduction in positive mood than those in the control condition. Participants who less frequently used reappraisal in their everyday lives benefited most from the manipulation.
Conclusions


Our results provide preliminary evidence that reappraising time alone as solitude may boost resilience to the decrements in positive mood associated with time alone. Limitations, clinical implications, and directions for future research are discussed.",2020,Participants who read about the benefits of solitude experienced a smaller reduction in positive mood than those in the control condition.,['Methods\n\n\nCollege students and community members ( N \u2009=\u2009220'],['reappraisal manipulation'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}]",[],220.0,0.0447612,Participants who read about the benefits of solitude experienced a smaller reduction in positive mood than those in the control condition.,"[{'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Bellet', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McNally', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA USA.'}]",Cognitive therapy and research,['10.1007/s10608-020-10128-x']
2300,32836837,Linking Human Destruction of Nature to COVID-19 Increases Support for Wildlife Conservation Policies.,"This paper investigates if narratives varying the cause of the COVID-19 pandemic affects pro-wildlife conservation outcomes. In a pre-registered online experiment (N = 1081), we randomly allocated subjects to either a control group or to one of three narrative treatment groups, each presenting a different likely cause of the COVID-19 outbreak: an animal cause; an animal and human cause (AHC); and an animal, human or lab cause. We found that the AHC narrative elicited significantly greater pro-conservation policy support, especially for bans in the commercial trade of wildlife, when compared to the control group. Possible mechanisms driving this effect are that AHC narratives were less familiar, elicited higher mental and emotional engagement, and induced feelings that firms and governments are responsible for mitigating wildlife extinction.",2020,"We found that the AHC narrative elicited significantly greater pro-conservation policy support, especially for bans in the commercial trade of wildlife, when compared to the control group.",[],[],[],[],[],[],,0.0243312,"We found that the AHC narrative elicited significantly greater pro-conservation policy support, especially for bans in the commercial trade of wildlife, when compared to the control group.","[{'ForeName': 'Ganga', 'Initials': 'G', 'LastName': 'Shreedhar', 'Affiliation': 'London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Mourato', 'Affiliation': 'London School of Economics and Political Science, London, UK.'}]",Environmental & resource economics,['10.1007/s10640-020-00444-x']
2301,32837131,How does brief guided mindfulness meditation enhance empathic concern in novice meditators?: A pilot test of the suggestion hypothesis vs. the mindfulness hypothesis.,"Despite the widespread popularity of mindfulness meditation for its various benefits, the mechanism underlying the meditation process has rarely been explored. Here, we present two preliminary studies designed to test alternative hypotheses: whether the effect of brief guided mindfulness meditation on empathic concern arises from verbal suggestion (suggestion hypothesis) or as a byproduct of an induced mindfulness state (mindfulness hypothesis). Study 1 was a pilot randomized control trial of sitting (breath-and-body) meditation vs. compassion meditation that provided preliminary support for the mindfulness hypothesis. Study 2 was set up to rule out the possibility that the meditation effects observed in Study 1 were the effects of repeated measures. An inactive control group of participants underwent the repeated measures of empathic concern with no meditation in between. The pre-post comparison demonstrated no significant changes in the measures. Thus, the results of two studies supported the mindfulness hypothesis. Limitations of the present study and future research directions are discussed.",2020,The pre-post comparison demonstrated no significant changes in the measures.,[],"['guided mindfulness meditation', 'sitting (breath-and-body) meditation vs. compassion meditation']",[],[],"[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",[],,0.012488,The pre-post comparison demonstrated no significant changes in the measures.,"[{'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Miyahara', 'Affiliation': 'Department of Clinical Psychological Science, School of Medicine, Hirosaki University, 66-1, Hon-cho, Hirosaki, Aomori 036-8564 Japan.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027 Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Pocock', 'Affiliation': 'School of Nursing, University of Auckland, Building 505, Level 2, 85 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'College of Letters, Ritsumeikan University, 56-1 Tojiin-kita-machi, Kita-ku, Kyoto, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fukuhara', 'Affiliation': 'College of Letters, Ritsumeikan University, 56-1 Tojiin-kita-machi, Kita-ku, Kyoto, Japan.'}]","Current psychology (New Brunswick, N.J.)",['10.1007/s12144-020-00881-3']
2302,32837162,Crime Rates in a Pandemic: the Largest Criminological Experiment in History.,"The COVID-19 pandemic of 2020 has impacted the world in ways not seen in generations. Initial evidence suggests one of the effects is crime rates, which appear to have fallen drastically in many communities around the world. We argue that the principal reason for the change is the government ordered stay-at-home orders, which impacted the routine activities of entire populations. Because these orders impacted countries, states, and communities at different times and in different ways, a naturally occurring, quasi-randomized control experiment has unfolded, allowing the testing of criminological theories as never before. Using new and traditional data sources made available as a result of the pandemic criminologists are equipped to study crime in society as never before. We encourage researchers to study specific types of crime, in a temporal fashion (following the stay-at-home orders), and placed-based. The results will reveal not only why, where, when, and to what extent crime changed, but also how to influence future crime reduction.",2020,"Initial evidence suggests one of the effects is crime rates, which appear to have fallen drastically in many communities around the world.",[],[],['Crime Rates'],[],[],"[{'cui': 'C0010325', 'cui_str': 'Crime'}]",,0.0228332,"Initial evidence suggests one of the effects is crime rates, which appear to have fallen drastically in many communities around the world.","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Stickle', 'Affiliation': 'Department of Criminal Justice Administration, Middle Tennessee State University, Murfreesboro, TN 37132 USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Felson', 'Affiliation': 'Texas State University, San Marcos, TX USA.'}]",American journal of criminal justice : AJCJ,['10.1007/s12103-020-09546-0']
2303,32837750,The Efficacy and Safety of Triazavirin for COVID-19: A Trial Protocol.,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.",2020,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019.","['240 participants with COVID-19 are scheduled to be enrolled in this trial', 'COVID-19 patients', 'Participants with positive tests of throat swab virus nucleic acid']","['placebo', 'Triazavirin (TZV', 'Triazavirin for COVID-19', 'standard therapy plus TZV or standard therapy plus placebo']","['clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients', 'Adverse events, serious adverse events, liver function, kidney function', 'time to clinical improvement of the subjects']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2714695', 'cui_str': 'triazavirin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",240.0,0.261526,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019.","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yongchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Wanhai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Benzhi', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}]","Engineering (Beijing, China)",['10.1016/j.eng.2020.06.011']
2304,32837799,Evaluating the Use of Mixed Reality to Teach Gross and Microscopic Respiratory Anatomy.,"Advances in technology often evolve into instructional platforms. This study evaluated the applicability of mixed reality (MR) in anatomy instruction. First-year medical students were randomized into a control group using a cadaver and light microscopes, or an experimental group using HoloLens, to complete a learning activity on gross and microscopic respiratory anatomy. Compared with the control group, the experimental group reached an equivalent score on the post-activity knowledge assessment, performed better on follow-up assessment, had consistently higher perceived understanding, and rated the activity higher. Findings suggest MR is an effective teaching tool and provides a favorable learning experience.",2020,"Compared with the control group, the experimental group reached an equivalent score on the post-activity knowledge assessment, performed better on follow-up assessment, had consistently higher perceived understanding, and rated the activity higher.",['First-year medical students'],"['control group using a cadaver and light microscopes, or an experimental group using HoloLens', 'mixed reality (MR']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0491970', 'cui_str': 'Light microscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}]",[],,0.0125723,"Compared with the control group, the experimental group reached an equivalent score on the post-activity knowledge assessment, performed better on follow-up assessment, had consistently higher perceived understanding, and rated the activity higher.","[{'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Robinson', 'Affiliation': 'Medical Student, Campbell University School of Osteopathic Medicine, Lillington, NC USA.'}, {'ForeName': 'Terence R', 'Initials': 'TR', 'LastName': 'Mitchell', 'Affiliation': 'Department of Anatomy, Campbell University School of Osteopathic Medicine, Lillington, NC USA.'}, {'ForeName': 'Bonnie M', 'Initials': 'BM', 'LastName': 'Brenseke', 'Affiliation': 'Department of Pathology, Campbell University School of Osteopathic Medicine, Lillington, NC USA.'}]",Medical science educator,['10.1007/s40670-020-01064-2']
2305,32837847,"A Randomized, Open-label, Controlled Clinical Trial of Azvudine Tablets in the Treatment of Mild and Common COVID-19, A Pilot Study.","Coronavirus disease 2019 (COVID-19) has spread worldwide. To date, no specific drug for COVID-19 has been developed. Thus we performed this randomized, open-label, controlled clinical trial (ChiCTR2000029853) in China. A total of 20 mild and common COVID-19 patients were enrolled and randomly assigned to receive azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatments (control group). The mean times of the first nucleic acid negative conversion (NANC) of 10 patients in the FNC group and 10 patients in the control group were 2.60 (SD 0.97; range 1-4) days and 5.60 (SD 3.06; range 2-13) days, respectively (p = 0.08). The mean times of the first NANC of 4 newly diagnosed subjects in the FNC group and 10 subjects in the control group were 2.50 (SD 1.00; range 2-4) days and 9.80 (SD 4.73; range 3-19) days, respectively (starting from the initial treatment) (p = 0.01). No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06). The preliminary results showed that FNC treatment in the mild and common COVID-19 may shorten the NANC time versus standard antiviral treatment. Therefore, clinical trials of FNC treating COVID-19 with larger sample size are warranted.",2020,"No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06).",['A total of 20 mild and common COVID-19 patients'],"['Azvudine Tablets', 'azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatments (control group', 'FNC']","['NANC time', 'mean times of the first nucleic acid negative conversion (NANC', 'adverse events', 'mean times of the first NANC']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4045536', 'cui_str': 'azvudine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0744737,"No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06).","[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Zujiang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Jingchao', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Thoracic Surgery Henan Provincial Chest Hospital Zhengzhou 450008 China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Henan Key Laboratory of Organic Functional Molecule and Drug Innovation School of Chemistry and Chemical Engineering Henan Normal University Xinxiang 453007 China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Haiyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Guangying', 'Initials': 'G', 'LastName': 'Cui', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Henan Genuine Biotech Co., Ltd. 10 Fuxing Road, Xincheng District Pingdingshan Henan 467036 P. R. China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics Huangchuan County People's Hospital Huangchuan County Xinyang 465150 China.""}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Medical Department Xixian people's Hospital Xixian Xinyang 464300 China.""}, {'ForeName': 'Zhaohai', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Shengkun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Pei', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery Henan Provincial Chest Hospital Zhengzhou 450008 China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Wenquan', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Chuanjun', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Chuansong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Jinfa', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Henan Genuine Biotech Co., Ltd. 10 Fuxing Road, Xincheng District Pingdingshan Henan 467036 P. R. China.'}, {'ForeName': 'Junbiao', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Henan Key Laboratory of Organic Functional Molecule and Drug Innovation School of Chemistry and Chemical Engineering Henan Normal University Xinxiang 453007 China.'}]","Advanced science (Weinheim, Baden-Wurttemberg, Germany)",['10.1002/advs.202001435']
2306,32838598,No place like home redesign: home-based clinical care as an interprofessional training model for medical and pharmacy students.,"Proper program assessment is necessary to ensure the delivered curriculum aligns with the intended curriculum. No Place Like Home (NPLH) is an interprofessional experience in which a healthcare team provides clinical services to patients in a home environment. Following review of program evaluation data, we determined the original design of NPLH was not meeting the intended objectives, and NPLH was redesigned in January 2018. Changes include lengthening the experience, decreasing the team size, improving assessment tools and additional training for the preceptors. The revised curriculum includes a care team with a preceptor, a medical, and a pharmacy student who visit four to six patients on an assigned day. From May 1, 2018 to April 30, 2019, there were 320 students who participated in NPLH. The preceptor assessments of students across the five objectives had mean scores of 3.4-3.7 on a 4 point scale indicating that on average preceptors placed students between  Demonstrates Competence  and  Demonstrates Excellence  for all objectives. When students were asked to compare their ability to collaborate interprofessionally after NPLH to the time before, 79% stated  Somewhat Better Now  or  Much Better Now . It is not sufficient to create interprofessional learning activities and assume learning objectives are being met. Ongoing performance assessment and curricular evaluation are essential to ensure such goals are achieved. When intended objectives are not being met, it is possible to make deliberate and purposeful changes to redirect interprofessional learning experiences while maintaining the integrity, novelty and uniqueness of the experience.",2020,The preceptor assessments of students across the five objectives had mean scores of 3.4-3.7 on a 4 point scale indicating that on average preceptors placed students between  Demonstrates Competence  and  Demonstrates Excellence  for all objectives.,"['2018 to April 30, 2019, there were 320 students who participated in NPLH', 'medical and pharmacy students']",['No Place Like Home (NPLH'],[],"[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}]","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],,0.0158383,The preceptor assessments of students across the five objectives had mean scores of 3.4-3.7 on a 4 point scale indicating that on average preceptors placed students between  Demonstrates Competence  and  Demonstrates Excellence  for all objectives.,"[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hatfield', 'Affiliation': 'Interprofessional Education, University of Houston College of Pharmacy.'}, {'ForeName': 'Anita Bagri', 'Initials': 'AB', 'LastName': 'Major', 'Affiliation': 'Department of Internal Medicine, Baylor College of Medicine , Houston, TX, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Purkiss', 'Affiliation': 'Evaluation, Assessment and Research, Baylor College of Medicine , Houston, TX, USA.'}, {'ForeName': ""Frene'"", 'Initials': 'F', 'LastName': 'LaCour-Chestnut', 'Affiliation': 'Interprofessional Education, University of Houston College of Pharmacy.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Gill', 'Affiliation': 'Interprofessional Education, Baylor College of Medicine , Houston, TX, USA.'}]",Journal of interprofessional care,['10.1080/13561820.2020.1801612']
2307,32838616,Evening aspirin intake results in higher levels of platelet inhibition and a reduction in reticulated platelets - a window of opportunity for patients with cardiovascular disease?,"Cardiovascular events occur most frequently in the early morning. Similarly, the release of reticulated platelets (RP) by megakaryocytes has a peak in the late night and early morning. Which aspirin regimen most effectively inhibits platelets during these critical hours is unknown. Hence, the primary objective of this trial was to assess platelet function and RP levels at 8.00 AM, in stable cardiovascular (CVD) patients, during three different aspirin regimens. In this open-label randomized cross-over study subjects were allocated to three sequential aspirin regimens: once-daily (OD) 80 mg morning; OD-evening, and twice-daily (BID) 40 mg. Platelet function was measured at 8.00 AM & 8.00 PM by serum Thromboxane B 2  (sTxB 2 ) levels, the Platelet Function Analyzer (PFA)-200® Closure Time (CT), Aspirin Reaction Units (ARU, VerifyNow®), and RP levels. In total, 22 patients were included. At 8.00 AM, sTxB 2  levels were the lowest after OD-evening in comparison with OD-morning ( p  = <0.01), but not in comparison with BID. Furthermore, RP levels were similar at 8.00 AM, but statistically significantly reduced at 8.00 PM after OD-evening ( p  = .01) and BID ( p  = .02) in comparison with OD-morning. OD-evening aspirin intake results in higher levels of platelet inhibition during early morning hours and results in a reduction of RP levels in the evening. These findings may, if confirmed by larger studies, be relevant to large groups of patients taking aspirin to reduce cardiovascular risk.",2020,OD-evening aspirin intake results in higher levels of platelet inhibition during early morning hours and results in a reduction of RP levels in the evening.,"['22 patients were included', 'patients with cardiovascular disease']","['aspirin regimens: once-daily (OD) 80 mg morning; OD-evening, and twice-daily (BID', 'OD-evening aspirin', 'aspirin']","['Cardiovascular events', 'platelet inhibition', 'Platelet function', 'serum Thromboxane B 2  (sTxB 2 ) levels, the Platelet Function Analyzer (PFA)-200® Closure Time (CT), Aspirin Reaction Units (ARU, VerifyNow®), and RP levels', 'release of reticulated platelets (RP', 'cardiovascular risk', 'platelet function and RP levels', 'RP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040061', 'cui_str': 'Thromboxane'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",22.0,0.0566153,OD-evening aspirin intake results in higher levels of platelet inhibition during early morning hours and results in a reduction of RP levels in the evening.,"[{'ForeName': 'J J K', 'Initials': 'JJK', 'LastName': 'van Diemen', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Madsen', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vrancken', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'de Bie', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'van der Bom', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center , Leiden, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Veen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Bonten', 'Affiliation': 'Department of Public Health & Primary Care, Leiden University Medical Center , Leiden, The Netherlands.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Fuijkschot', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Smulders', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thijs', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VU University , Amsterdam, The Netherlands.'}]",Platelets,['10.1080/09537104.2020.1809643']
2308,32838641,Efficacy of Adenoidectomy for the Treatment of Mild Sleep Apnea in Children.,"OBJECTIVES


(1) To assess outcomes in children undergoing adenoidectomy for the treatment of mild obstructive sleep apnea (OSA). (2) To identify clinical factors that predict which children will have persistent obstruction following adenoidectomy.
STUDY DESIGN


Case series with chart review over a 10-year period.
SETTING


Tertiary children's hospital.
SUBJECTS AND METHODS


Children between 2 and 17 years old undergoing adenoidectomy for treatment of mild OSA (obstructive apnea-hypopnea index [AHI] between 1 and 5 on polysomnogram) were included. The need for additional medical or surgical intervention following adenoidectomy was recorded. When available, postoperative polysomnogram data were reviewed.
RESULTS


In total, 134 children with a mean age of 5.4 years were included. Fifty-three percent (n = 71) were female and 57% (n = 76) were black. The mean (SD) baseline AHI was 2.2 (1.09). Caregivers reported a moderate impact of sleep disturbance on quality of life with a mean (SD) preoperative total OSA-18 score of 64.1 (19.28). Postadenoidectomy outcomes were reported for 105 patients (78%) with a mean follow-up time of 6 months. Sixty-nine percent (n = 72) of children had resolution of obstructive symptoms. While 31% (n = 33) of children required additional intervention following adenoidectomy, only 6.8% (n = 9) underwent a subsequent tonsillectomy. Demographic factors such as age and baseline AHI did not predict which children required additional treatment following adenoidectomy.
CONCLUSION


Adenoidectomy may be an effective treatment for mild OSA. A randomized trial comparing outcomes for adenoidectomy and adenotonsillectomy is needed to determine the ideal surgical treatment for nonsevere OSA in children.",2020,"While 31% (n = 33) of children required additional intervention following adenoidectomy, only 6.8% (n = 9) underwent a subsequent tonsillectomy.","[""Tertiary children's hospital"", 'Fifty-three percent (n = 71) were female and 57% (n = 76) were black', 'nonsevere OSA in children', '134 children with a mean age of 5.4 years were included', 'Mild Sleep Apnea in Children', 'Children between 2 and 17 years old undergoing adenoidectomy for treatment of mild OSA (obstructive apnea-hypopnea index [AHI] between 1 and 5 on polysomnogram) were included', 'children undergoing adenoidectomy for the treatment of mild obstructive sleep apnea (OSA']","['adenoidectomy and adenotonsillectomy', 'Adenoidectomy']","['sleep disturbance on quality of life with a mean (SD) preoperative total OSA-18 score', 'mean (SD) baseline AHI', 'resolution of obstructive symptoms']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",134.0,0.119713,"While 31% (n = 33) of children required additional intervention following adenoidectomy, only 6.8% (n = 9) underwent a subsequent tonsillectomy.","[{'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Tipold', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, Virginia, USA.'}, {'ForeName': 'Turaj', 'Initials': 'T', 'LastName': 'Vazifedan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of The King's Daughters, Norfolk, Virginia, USA.""}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Baldassari', 'Affiliation': ""Department of Pediatric Sleep Medicine, Children's Hospital of The King's Daughters, Norfolk, Virginia, USA.""}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820950719']
2309,32838647,Pharmacogenomics and pharmacokinetics of efavirenz 400 or 600 mg in 184 treatment-naive HIV-infected patients in China.,"Background:  The pharmacogenomics and pharmacokinetics/pharmacodynamics of 400 mg efavirenz have rarely been reported.  Materials & methods:  A total of 184 treatment-naive HIV-infected patients were randomly assigned (1:1) to receive a lower dose (tenofovir disoproxil 200 mg, efavirenz 400 mg and lamivudine) or a standard dose regimen. Relationships between pharmacogenomics and efavirenz pharmacokinetics/pharmacodynamics were explored at 48 weeks.  Results:  There was no relationship between pharmacogenomics and adverse reactions of the central nervous system and antiretoviral efficacy. CYP2B6  516G>T ,  785A>G ,  18492C>T  and ABCB1  3435C>T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower-dose group. No relationship was found between pharmacogenomics and antiretoviral efficacy. Patients who were <60 kg had higher efavirenz concentration compared with those with weight ≥60 kg when using 600 mg efavirenz, this was not observed with 400 mg efavirenz.  Conclusion:  The effect of pharmacogenomics and body weight on the efavirenz concentration was significant in the 600 mg group but not in the 400 mg group.",2020,T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower-dose group.,"['184 treatment-naive HIV-infected patients in China', 'A total of 184 treatment-naive HIV-infected patients']","['lower dose (tenofovir disoproxil 200\xa0mg, efavirenz 400\xa0mg and\xa0lamivudine', 'efavirenz']","['efavirenz plasma levels', 'T  and ABCB1  3435C', 'efavirenz concentration']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4555930', 'cui_str': 'efavirenz 400 MG'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0548373,T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower-dose group.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Jingna', 'Initials': 'J', 'LastName': 'Xun', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Infectious Disease, The Second Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Yunnan AIDS Care Center (YNACC), Yunnan Provincial Infectious Disease Hospital, Kunming, 650500, China.'}, {'ForeName': 'Renfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Corky', 'Initials': 'C', 'LastName': 'Steinhart', 'Affiliation': 'CAN Community Health, FL 34232, USA.'}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}]",Pharmacogenomics,['10.2217/pgs-2019-0169']
2310,32838661,Preventive effect of trimetazidine on contrast-induced nephropathy undergoing percutaneous coronary intervention in elderly moderate and high risk diabetics stratified by mehran score.,"BACKGROUND


The aim of this research was to use the Mehran risk score to classify elderly diabetics with coronary heart disease to assess the preventive effect of trimetazidine on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) in different risk population.
METHODS


An uncompromised of 760 elderly diabetics that went through PCI were included in this research. The patients were first divided into three groups in the light of MRS: low-risk, moderate-risk, and high-risk group, then randomized into trimetazidine group and the control group respectively. The first endpoint was the amount of CIN, which is described as a rise in serum creatinine levels by ⩾44.2 μmol/L or ⩾25% ratio within 48 or 72 hours after medication. Second endpoint included differences in creatinine clearance rate (CrCl), blood urea nitrogen (BUN), serum creatinine (Scr), cystatin-C (Cys-C), and the incidence of major adverse events after administration.
RESULTS


In the three groups, the incidence of CIN in trimetazidine and control group was 5.0% versus 4.9%(χ 2  = 0.005, p > 0.05), 8.0% versus 18.0% (χ 2  = 7.685, p < 0.05), 10.4% versus 27.1% (χ 2  = 4.376, p < 0.05), respectively. The multivariable logistic regression result demonstrated that trimetazidine intervention was a profitable element of CIN in moderate and high-risk groups (OR = 0.294, 95% CI 0.094-0.920, p = 0.035).
CONCLUSION


Our study confirmed that trimetazidine can be considered for preventive treatment of CIN occurrence in elderly diabetics with moderate and high-risk population, while there is no obvious advantage compared with hydration therapy in low-risk patients.",2020,"In the three groups, the incidence of CIN in trimetazidine and control group was 5.0% versus 4.9%(χ 2  = 0.005, p > 0.05), 8.0% versus 18.0% (χ 2  = 7.685, p < 0.05), 10.4% versus 27.1% (χ 2  = 4.376, p < 0.05), respectively.","['elderly diabetics with coronary heart disease', '760 elderly diabetics that went through PCI', 'elderly diabetics with moderate and high-risk population', 'elderly moderate and high risk diabetics stratified by mehran score']","['percutaneous coronary intervention (PCI', 'hydration therapy', 'percutaneous coronary intervention', 'trimetazidine']","['incidence of CIN', 'creatinine clearance rate (CrCl), blood urea nitrogen (BUN), serum creatinine (Scr), cystatin-C (Cys-C), and the incidence of major adverse events after administration', 'amount of CIN', 'serum creatinine levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0041037', 'cui_str': 'Trimetazidine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",760.0,0.0280771,"In the three groups, the incidence of CIN in trimetazidine and control group was 5.0% versus 4.9%(χ 2  = 0.005, p > 0.05), 8.0% versus 18.0% (χ 2  = 7.685, p < 0.05), 10.4% versus 27.1% (χ 2  = 4.376, p < 0.05), respectively.","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Graduate School of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Shicheng', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Wenyuan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Xiuzhen', 'Initials': 'X', 'LastName': 'Men', 'Affiliation': ""Department of Catheter lab, Dongying Second People's Hospital, Shandong,China.""}, {'ForeName': 'Naikuan', 'Initials': 'N', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital, Tianjin, China.'}]",Perfusion,['10.1177/0267659120952057']
2311,32842955,Procedural sedation for direct current cardioversion: a feasibility study between two management strategies in the emergency department.,"BACKGROUND


A cardiologist-only approach to procedural sedation with midazolam in the setting of elective cardioversion (DCC) for AF has already been proven as safe as sedation with propofol and anaesthesiologist assistance. No data exist regarding the safety of such a strategy during emergency procedures. The aim of this study is to compare the feasibility of sedation with midazolam, administered by a cardiologist, to an anaesthesiologist-assisted protocol with propofol in emergency DCC.
METHODS


Single centre, prospective, open blinded, randomized study including all consecutive patients admitted to the Emergency Department requiring urgent or emergency DCC. Patients were randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the midazolam group were managed by the cardiologist only, while patients treated with propofol group underwent DCC with anaesthesiologist assistance.
RESULTS


Sixty-nine patients were enrolled and split into two groups. Eighteen patients (26.1%) experienced peri-procedural adverse events (bradycardia, severe hypotension and severe hypoxia), which were similar between the two groups and all successfully managed by the cardiologist. No deaths, stroke or need for invasive ventilation were registered. Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam. As the procedure was shorter when midazolam was used, the median cost of urgent/emergency DCC with midazolam was estimated to be 129.0 € (1st-3rd quartiles 114.6-151.6) and 195.6 € (1st-3rd quartiles 147.3-726.7) with propofol (p < .001).
CONCLUSIONS


Procedural sedation with midazolam given by the cardiologist alone was feasible, well-tolerated and cost-effective in emergency DCC.",2020,Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam.,"['all consecutive patients admitted to the Emergency Department requiring urgent or emergency DCC', 'Sixty-nine patients']","['propofol', 'propofol or midazolam', 'midazolam', 'DCC with anaesthesiologist assistance']","['peri-procedural adverse events (bradycardia, severe hypotension and severe hypoxia', 'systolic and diastolic blood pressure', 'No deaths, stroke or need for invasive ventilation', 'median cost of urgent/emergency DCC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1259909', 'cui_str': 'DCC protein, human'}, {'cui': 'C0450388', 'cui_str': '69'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C1259909', 'cui_str': 'DCC protein, human'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1259909', 'cui_str': 'DCC protein, human'}]",69.0,0.0191994,Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam.,"[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Stronati', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti Umberto I - Lancisi - Salesi"", Via Conca 71, Ancona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Capucci', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti Umberto I - Lancisi - Salesi"", Via Conca 71, Ancona, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Russo', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti Umberto I - Lancisi - Salesi"", Via Conca 71, Ancona, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Adrario', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Marche Polytechnic University, University Hospital ""Ospedali Riuniti"", Ancona, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carsetti', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Marche Polytechnic University, University Hospital ""Ospedali Riuniti"", Ancona, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casella', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti Umberto I - Lancisi - Salesi"", Via Conca 71, Ancona, Italy.'}, {'ForeName': 'Abele', 'Initials': 'A', 'LastName': 'Donati', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Marche Polytechnic University, University Hospital ""Ospedali Riuniti"", Ancona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Guerra', 'Affiliation': 'Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital ""Ospedali Riuniti Umberto I - Lancisi - Salesi"", Via Conca 71, Ancona, Italy. f.guerra@univpm.it.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01664-1']
2312,32842965,The influence of care home managers on the implementation of a complex intervention: findings from the process evaluation of a randomised controlled trial of dementia care mapping.,"BACKGROUND


Many people with dementia live in care homes, where staff can struggle to meet their complex needs. Successful practice improvement interventions in these settings require strong managerial support, but little is known about how managers can support implementation in practice, or what factors support or hinder care home managers in providing this support. Using Dementia Care Mapping™ (DCM) as an example, this study explored how care home managers can support the implementation of complex interventions, and identified factors affecting their ability to provide this support.
METHODS


We undertook interviews with 48 staff members (managers and intervention leads) from care homes participating in the intervention arm of the DCM EPIC trial of DCM implementation.
RESULTS


Managerial support played a key role in facilitating the implementation of a complex intervention in care home settings. Managers could provide practical and financial support in many forms. However, managerial support and leadership approaches towards implementation were highly variable in practice, and implementation was easily de-stabilised by management changes or competing managerial priorities. How well managers understood, valued and engaged with the intervention, alongside the leadership style they adopted to support implementation, were key influences on implementation success.
CONCLUSIONS


For care home managers to effectively support interventions they must fully understand the proposed intervention and its potential value. This is especially important during times of managerial or practice changes, when managers lack the skills required to effectively support implementation, or when the intervention is complex. It may be unfeasible to successfully implement new interventions during times of managerial or practice instability.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN82288852 , registered 16/01/2014.",2020,"Using Dementia Care Mapping™ (DCM) as an example, this study explored how care home managers can support the implementation of complex interventions, and identified factors affecting their ability to provide this support.
",['48 staff members (managers and intervention leads) from care homes participating in the intervention arm of the DCM EPIC trial of DCM implementation'],['Dementia Care Mapping™ (DCM'],[],"[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}]",[],,0.0642747,"Using Dementia Care Mapping™ (DCM) as an example, this study explored how care home managers can support the implementation of complex interventions, and identified factors affecting their ability to provide this support.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kelley', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, Leeds, LS1 3HE, UK. r.kelley@leedsbeckett.ac.uk.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, Leeds, LS1 3HE, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shoesmith', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, Leeds, LS1 3HE, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McDermid', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Couch', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Robinson', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, Leeds, LS1 3HE, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Perfect', 'Affiliation': 'Oxfordshire NHS Trust, Oxfordshire, UK.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Surr', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, Leeds, LS1 3HE, UK.'}]",BMC geriatrics,['10.1186/s12877-020-01706-5']
2313,32842971,Improving mental wellbeing of forensic psychiatric outpatients through the addition of an informal social network intervention to treatment as usual: a randomized controlled trial.,"BACKGROUND


Forensic psychiatric patients often suffer from a multitude of severe psychiatric and social problems. Meanwhile multimodal evidence-based interventions are scarce and treatment effectiveness is in need of improvement. The main goal of forensic psychiatric treatment is to address psychiatric and social factors and thereby mitigate criminal behaviour. Notably, a supportive social network is an important protective factor for criminal behaviour. As such, improving a poor social network may decrease the risk of criminal recidivism. This study aims to examine the effectiveness of the addition of an informal social network intervention (FNC) to treatment as usual (TAU) among forensic psychiatric outpatients.
METHODS


In a mono-center randomized controlled clinical trial with two parallel groups, forensic psychiatric outpatients with social network-related problems (N = 105) will be allocated to either TAU + FNC or TAU alone. The informal social network intervention consists of a 12-month coaching intervention, performed by the forensic network coach (a volunteer trained by an informal care institute). Assessments will be conducted at baseline and 3 months, 6 months, 9 months, 12 months, and 18 months after baseline. The primary outcome variable is mental wellbeing. Psychiatric functioning, criminal recidivism, substance abuse, quality of life, social network, social support, loneliness and self-sufficiency are included as secondary outcomes. A variety of potential mediators and moderators of effectiveness will be explored. Additionally, a qualitative evaluation of effectiveness will be performed.
DISCUSSION


This study will contribute to the existing literature of forensic treatment effectiveness as it is the first RCT examining the effectiveness of adding a social network intervention in a forensic outpatient population. If effectiveness is shown, forensic mental health care could be optimized by collaborating with informal care or community initiatives aimed at improving a positive social network. In addition, results will provide insight regarding mediators and moderators of treatment effectiveness.
TRIAL REGISTRATION


This study is registered at the Netherlands Trial Register ( NTR7163 ). Date of registration: 16 april 2018.",2020,"This study aims to examine the effectiveness of the addition of an informal social network intervention (FNC) to treatment as usual (TAU) among forensic psychiatric outpatients.
","['forensic psychiatric outpatients with social network-related problems (N\xa0=\u2009105', 'Forensic psychiatric patients often suffer from a multitude of severe psychiatric and social problems', 'forensic psychiatric outpatients']","['social network intervention', 'TAU + FNC or TAU alone', 'informal social network intervention (FNC', 'informal social network intervention']","['mental wellbeing', 'Psychiatric functioning, criminal recidivism, substance abuse, quality of life, social network, social support, loneliness and self-sufficiency']","[{'cui': 'C0016557', 'cui_str': 'Medicine, Forensic'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.168294,"This study aims to examine the effectiveness of the addition of an informal social network intervention (FNC) to treatment as usual (TAU) among forensic psychiatric outpatients.
","[{'ForeName': 'L T A', 'Initials': 'LTA', 'LastName': 'Swinkels', 'Affiliation': 'Inforsa Forensic Mental Health Care, Vlaardingenlaan 5, 1059, GL, Amsterdam, the Netherlands. lise.swinkels@inforsa.nl.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'van der Pol', 'Affiliation': 'Inforsa Forensic Mental Health Care, Vlaardingenlaan 5, 1059, GL, Amsterdam, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Popma', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Amsterdam University Medical Center, Meibergdreef 5, 1105, AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Ter Harmsel', 'Affiliation': 'Inforsa Forensic Mental Health Care, Vlaardingenlaan 5, 1059, GL, Amsterdam, the Netherlands.'}, {'ForeName': 'J J M', 'Initials': 'JJM', 'LastName': 'Dekker', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Klaprozenweg 111, 1033, NN, Amsterdam, the Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02819-2']
2314,32842975,The CanMoRe trial - evaluating the effects of an exercise intervention after robotic-assisted radical cystectomy for urinary bladder cancer: the study protocol of a randomised controlled trial.,"BACKGROUND


Patients who have undergone radical cystectomy for urinary bladder cancer are not sufficiently physically active and therefore may suffer complications leading to readmissions. A physical rehabilitation programme early postoperatively might prevent or at least alleviate these potential complications and improve physical function. The main aim of the CanMoRe trial is to evaluate the impact of a standardised and individually adapted exercise intervention in primary health care to improve physical function (primary outcome) and habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions due to complications in patients undergoing robotic-assisted radical cystectomy for urinary bladder cancer.
METHODS


In total, 120 patients will be included and assigned to either intervention or control arm of the study. All patients will receive preoperative information on the importance of early mobilisation and during the hospital stay they will follow a standard protocol for enhanced mobilisation. The intervention group will be given a referral to a physiotherapist in primary health care close to their home. Within the third week after discharge, the intervention group will begin 12 weeks of biweekly exercise. The exercise programme includes aerobic and strengthening exercises. The control group will receive oral and written information about a home-based exercise programme. Physical function will serve as the primary outcome and will be measured using the Six-minute walk test. Secondary outcomes are gait speed, handgrip strength, leg strength, habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions due to complications. The measurements will be conducted at discharge (i.e. baseline), post-intervention and 1 year after surgery. To evaluate the effects of the intervention mixed or linear regression models according to the intention to treat procedure will be used.
DISCUSSION


This proposed randomised controlled trial has the potential to provide new knowledge within rehabilitation after radical cystectomy for urinary bladder cancer. The programme should be easy to apply to other patient groups undergoing abdominal surgery for cancer and has the potential to change the health care chain for these patients.
TRIAL REGISTRATION


ClinicalTrials.gov. Clinical trial registration number NCT03998579 . First posted June 26, 2019.",2020,"The programme should be easy to apply to other patient groups undergoing abdominal surgery for cancer and has the potential to change the health care chain for these patients.
","['urinary bladder cancer', 'Patients who have undergone radical cystectomy for urinary bladder cancer', '120 patients will be included and assigned to either intervention or control arm of the study', 'patients undergoing']","['standardised and individually adapted exercise intervention', 'exercise intervention after robotic-assisted radical cystectomy', 'robotic-assisted radical cystectomy', 'radical cystectomy', 'exercise programme includes aerobic and strengthening exercises', 'oral and written information about a home-based exercise programme']","['gait speed, handgrip strength, leg strength, habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions due to complications', 'habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions']","[{'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",120.0,0.141516,"The programme should be easy to apply to other patient groups undergoing abdominal surgery for cancer and has the potential to change the health care chain for these patients.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Porserud', 'Affiliation': 'Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden. andrea.porserud@ki.se.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Rydwik', 'Affiliation': 'Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Aly', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Henningsohn', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, CLINTEC, Division of Urology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Nygren-Bonnier', 'Affiliation': 'Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hagströmer', 'Affiliation': 'Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.'}]",BMC cancer,['10.1186/s12885-020-07140-5']
2315,32843075,Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients-a protocol for the prospective randomized controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study.,"BACKGROUND


Critically ill patients rapidly develop muscle wasting resulting in sarcopenia, long-term disability and higher mortality. Bolus nutrition (30-60 min period), whilst having a similar incidence of aspiration as continuous feeding, seems to provide metabolic benefits through increased muscle protein synthesis due to higher leucine peaks. To date, clinical evidence on achievement of nutritional goals and influence of bolus nutrition on skeletal muscle metabolism in ICU patients is lacking. The aim of the Pro BoNo study (Protein Bolus Nutrition) is to compare intermittent and continuous enteral feeding with a specific high-protein formula. We hypothesise that target quantity of protein is reached earlier (within 36 h) by an intermittent feeding protocol with a favourable influence on muscle protein synthesis.
METHODS


Pro BoNo is a prospective randomised controlled study aiming to compare the impact of intermittent and continuous enteral feeding on preventing muscle wasting in 60 critically ill patients recruited during the first 48 h after ICU admission. The primary outcome measure is the time until the daily protein target (≥ 1.5 g protein/kg bodyweight/24 h) is achieved. Secondary outcome measures include tolerance of enteral feeding and evolution of glucose, urea and IGF-1. Ultrasound and muscle biopsy of the quadriceps will be performed.
DISCUSSION


The Basel Pro BoNo study aims to collect innovative data on the effect of intermittent enteral feeding of critically ill patients on muscle wasting.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03587870 . Registered on July 16, 2018. Swiss National Clinical Trials Portal SNCTP000003234. Last updated on July 24, 2019.",2020,"Secondary outcome measures include tolerance of enteral feeding and evolution of glucose, urea and IGF-1.","['60 critically ill patients recruited during the first 48\u2009h after ICU admission', 'ICU patients', 'Pro', 'critically ill patients on muscle wasting', 'critically ill patients']",['intermittent and continuous enteral feeding'],"['skeletal muscle metabolism', 'tolerance of enteral feeding and evolution of glucose, urea and IGF-1', 'time until the daily protein target (≥\u20091.5\u2009g protein/kg bodyweight/24\u2009h']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1159372', 'cui_str': 'Cellular Protein Targeting'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0086376', 'cui_str': 'G protein'}]",60.0,0.0560978,"Secondary outcome measures include tolerance of enteral feeding and evolution of glucose, urea and IGF-1.","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Reinhold', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Yeginsoy', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland. alexa.hollinger@usb.ch.'}, {'ForeName': 'Atanas', 'Initials': 'A', 'LastName': 'Todorov', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tintignac', 'Affiliation': 'Department of Biomedicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sinnreich', 'Affiliation': 'Departments of Biomedicine and Neurology, Centre of Neuromuscular Diseases, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kiss', 'Affiliation': 'Department of Clinical Nutrition, University Department of Geriatric Medicine Felix Platter, Basel, Switzerland.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Gebhard', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Kovács', 'Affiliation': 'Department of Radiology, Musculoskeletal Diagnostics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Gysi', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Imwinkelried', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}]",Trials,['10.1186/s13063-020-04635-1']
2316,32843079,"Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial.","BACKGROUND


Iron deficiency is common in pregnancy. If left untreated, iron deficiency can lead to iron deficiency anaemia, which is a condition related to maternal and neonatal morbidity. The prevalence of iron deficiency increases through the trimesters, which means that women with iron deficiency in the beginning of pregnancy also have a great risk of developing iron deficiency anaemia during pregnancy. Standard treatment is oral iron in individualised intensified doses based on screening values in 1st trimester. Maternal symptoms of iron deficiency and iron deficiency anaemia include fatigue, reduced physical performance, and restless legs syndrome (RLS). Severe anaemia may cause dizziness, dyspnea, palpitation, orthostatism, and syncope, and it decreases the woman's ability to cope with blood loss during delivery. The anaemia may also compromise contractility in the uterine musculature increasing the risk for prolonged labour, caesarean section, and postpartum haemorrhage. Foetal iron deficiency may cause low birthweight and adversely affect foetal and early childhood brain development with long-term deficits.
METHODS


In this randomised comparative, open-label, single-centre, phase IV trial, 200 pregnant women between 14 and 21 weeks of gestation who have iron deficiency after 4 weeks of standard treatment will be randomised 1:1 to either a single 1000 mg dose of intravenously administered ferric derisomaltose/iron isomaltoside 1000 or a fixed dose of 100 mg oral ferrous fumarate containing 60 mg ascorbic acid. The primary endpoint is to prevent iron deficiency anaemia defined by a low level of haemoglobin throughout the trial. Other endpoints include other haematological indices of iron deficiency and anaemia, clinical outcomes by questionnaires, and collection of adverse events. Explorative endpoints by medical record follow-up include complications up to 7 days after delivery.
DISCUSSION


This trial will provide evidence on how to prevent iron deficiency anaemia. The trial population represents a clinical reality where pregnant women often have sustained iron deficiency despite an increased oral iron dose. Thus, this evidence can be used to consider the optimal 2nd line of treatment in iron-deficient pregnant women.
TRIAL REGISTRATION


European Union Drug Regulating Authorities Clinical Trials Database 2017-000776-29. Registered on 3 May 2017. ClinicalTrials.gov NCT03188445 . Registered on 15 June 2017.",2020,"Foetal iron deficiency may cause low birthweight and adversely affect foetal and early childhood brain development with long-term deficits.
","['200 pregnant women between 14 and 21\u2009weeks of gestation who have iron deficiency after 4\u2009weeks of standard treatment', 'pregnant women often have sustained iron deficiency despite an increased oral iron dose', 'iron deficiency in pregnancy']","['single 1000\u2009mg dose of intravenously administered ferric derisomaltose/iron isomaltoside 1000 or a fixed dose of 100\u2009mg oral ferrous fumarate containing 60\u2009mg ascorbic acid', 'Intravenous iron isomaltoside versus oral iron supplementation']","['Severe anaemia may cause dizziness, dyspnea, palpitation, orthostatism, and syncope', 'Maternal symptoms of iron deficiency and iron deficiency anaemia include fatigue, reduced physical performance, and restless legs syndrome (RLS', 'haematological indices of iron deficiency and anaemia, clinical outcomes by questionnaires, and collection of adverse events', 'prevent iron deficiency anaemia defined by a low level of haemoglobin']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C2947549', 'cui_str': 'iron isomaltoside 1000'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",200.0,0.699753,"Foetal iron deficiency may cause low birthweight and adversely affect foetal and early childhood brain development with long-term deficits.
","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Markova', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amager-Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark. veronika.markova.04@regionh.dk.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amager-Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Lars Lykke', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Pharmacosmos A/S, Roervangsvej 30, 4300, Holbaek, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Fertility Clinic, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Moos', 'Affiliation': 'Laboratory of Neurobiology, Department of Health Science and Technology, Aalborg University, Fredrik Bajers Vej 7, 9220, Aalborg, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Holm', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amager-Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}]",Trials,['10.1186/s13063-020-04637-z']
2317,32843081,"""Protocol for a phase 2, randomized, double-blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction"": study protocol for a randomized controlled trial.","BACKGROUND


Regenerative therapies offer new approaches to improve cardiac function after acute ST-elevation myocardial infarction (STEMI). Previous trials using bone marrow cells, selected stem cell populations, or cardiac stem cell progenitors require invasive procedures and had so far inconclusive results. A less invasive approach utilizes granulocyte-colony stimulating factor (G-CSF) to mobilize stem cells to circulating blood and induce neovascularization and differentiation into endothelial cells and cardiomyocytes. Stromal cell-derived factor 1 alpha (SDF-1α) is an important chemokine for initiating stem cell migration and homing to ischemic myocardium. SDF-1α concentrations can be increased by inhibition of CD26/DPP4. Dutogliptin, a novel DPP4 inhibitor, combined with stem cell mobilization using G-CSF significantly improved survival and reduced infarct size in a murine model.
METHODS


We test the safety and tolerability and efficacy of dutogliptin in combination with filgrastim (G-CSF) in patients with STEMI (EF < 45%) following percutaneous coronary intervention (PCI). Preliminary efficacy will be analyzed using cardiac magnetic resonance imaging (cMRI) to detect > 3.8% improvement in left ventricular ejection fraction (LV-EF) compared to placebo. One hundred forty subjects will be randomized to filgrastim plus dutogliptin or matching placebos.
DISCUSSION


The REC-DUT-002 trial is the first to evaluate dutogliptin in combination with G-CSF in patients with STEMI. Results will lay the foundation for an appropriately powered cardiovascular outcome trial to test the efficacy of this combined pharmacological strategy.
TRIAL REGISTRATION


EudraCT no.: 2018-000916-75 . Registered on 7 June 2018. IND number: 123717.",2020,"Dutogliptin, a novel DPP4 inhibitor, combined with stem cell mobilization using G-CSF significantly improved survival and reduced infarct size in a murine model.
","['One hundred forty subjects', 'patients with STEMI (EF\u2009<\u200945%) following', 'patients with STEMI', 'early recovery post-myocardial infarction']","['dutogliptin', 'percutaneous coronary intervention (PCI', 'granulocyte-colony stimulating factor (G-CSF', 'filgrastim (G-CSF', 'dutogliptin in combination with filgrastim', 'placebo', 'filgrastim plus dutogliptin or matching placebos', 'Stromal cell-derived factor 1 alpha (SDF-1α', 'EudraCT']","['survival and reduced infarct size', 'SDF-1α concentrations', 'left ventricular ejection fraction (LV-EF', 'cardiac function', 'safety and tolerability and efficacy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C2828326', 'cui_str': 'dutogliptin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",140.0,0.473153,"Dutogliptin, a novel DPP4 inhibitor, combined with stem cell mobilization using G-CSF significantly improved survival and reduced infarct size in a murine model.
","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'von Lewinski', 'Affiliation': 'Department of Cardiology, Medical University of Graz, Graz, Austria. dirk.von-lewinski@medunigraz.at.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': 'Department of Cardiovascular Medicine, Flinders University of South Australia, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Schatz', 'Affiliation': 'Gene and Cell Therapy, Scripps Clinic, La Jolla, CA, USA.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Nicolaus Copernicus University, Bydgoszcz, Poland.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute and Duke Medicine, Duke University, Durham, NC 27705, USA.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'Nix', 'Affiliation': 'RECARDIO Inc., San Francisco, CA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Henauer', 'Affiliation': 'RECARDIO Inc., San Francisco, CA, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wallner', 'Affiliation': 'Department of Cardiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04652-0']
2318,32843084,"Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial.","BACKGROUND


Fire needle therapy is a characteristic treatment in traditional Chinese medicine (TCM). An increasing number of studies have indicated that fire needle treatment for psoriasis provides satisfactory results with few side effects and a low recurrence rate. We herein describe the protocol for a multicenter, randomized, single-blind, placebo-controlled trial that will provide high-quality evidence on the efficacy and safety of fire needle therapy for plaque psoriasis.
METHODS


Ninety-two patients with blood stasis syndrome (BSS) of plaque psoriasis will be enrolled and randomly assigned to receive fire needle therapy (intervention group) or fire needle control therapy (control group) once a week for 4 weeks. The Psoriasis Area and Severity Index (PASI) score will serve as the major efficacy index, while the body surface area (BSA), Physician Global Assessment (PGA) score, Dermatology Life Quality Index (DLQI) score, patient-reported quality of life (PRQoL), visual analog scale (VAS) score for itching, TCM symptom score, and relapse rate will be assessed as secondary outcomes. The PASI score, BSA, PGA score, and VAS score for itching will be evaluated at baseline and during the 4-week treatment and follow-up periods. DLQI score, PRQoL, and TCM symptom score will be assessed at baseline and during the treatment period. Recurrence will be evaluated during the follow-up period. Safety assessments include vital sign monitoring, routine blood tests, blood biochemistry, routine urine tests, pregnancy tests, physical examinations, and adverse-event recording. SAS software will be used for data analysis. The data network platform will be designed by the data management center of Nanjing Ningqi Medical Technology Co., Ltd.
DISCUSSION


It is believed that fire needle therapy can activate the meridians, promote blood circulation, and regulate skin immunity. BSS of plaque psoriasis is related to not only immune dysfunction but also poor or stagnant blood flow. We anticipate that the results of the trial described in this protocol will provide strong evidence for the safety and efficacy of fire needle therapy for BSS of plaque psoriasis.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03953885 . Registered on May 15, 2019. Name: Fire Needle Therapy on Plaque Psoriasis with Blood Stasis Syndrome.",2020,"The PASI score, BSA, PGA score, and VAS score for itching will be evaluated at baseline and during the 4-week treatment and follow-up periods.","['Plaque Psoriasis with Blood Stasis Syndrome', 'blood stasis syndrome of plaque psoriasis', 'Ninety-two patients with blood stasis syndrome (BSS) of plaque psoriasis']","['Fire Needle Therapy', 'placebo', 'fire needle therapy (intervention group) or fire needle control therapy (control group', 'fire needle therapy']","['efficacy and safety', 'vital sign monitoring, routine blood tests, blood biochemistry, routine urine tests, pregnancy tests, physical examinations, and adverse-event recording', 'Psoriasis Area and Severity Index (PASI) score', 'PASI score, BSA, PGA score, and VAS score for itching', 'Efficacy and safety', 'DLQI score, PRQoL, and TCM symptom score', 'Recurrence', 'body surface area (BSA), Physician Global Assessment (PGA) score, Dermatology Life Quality Index (DLQI) score, patient-reported quality of life (PRQoL), visual analog scale (VAS) score for itching, TCM symptom score, and relapse rate']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",92.0,0.0431729,"The PASI score, BSA, PGA score, and VAS score for itching will be evaluated at baseline and during the 4-week treatment and follow-up periods.","[{'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Xiao-Ning', 'Initials': 'XN', 'LastName': 'Yan', 'Affiliation': ""Department of Dermatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi'an, 710003, Shannxi, China.""}, {'ForeName': 'Su-Qing', 'Initials': 'SQ', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, 150040, Heilongjiang, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Gong', 'Affiliation': 'Department of Dermatology, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Ling-E', 'Initials': 'LE', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Traditional Chinese Medicine Hospital of Shijiazhuang, Shijiahzuang, 050011, Hebei, China.'}, {'ForeName': 'Yi-Ding', 'Initials': 'YD', 'LastName': 'Zhao', 'Affiliation': ""Department of Dermatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi'an, 710003, Shannxi, China.""}, {'ForeName': 'Qing-Feng', 'Initials': 'QF', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Famous Medical Technology Co. Ltd, Nanjing University of Traditional Chinese Medicine, Floor 2, Building 19, Nanjing, 210029, China.'}, {'ForeName': 'Rui-Ping', 'Initials': 'RP', 'LastName': 'Wang', 'Affiliation': 'Office of Clinical Medical Research Center, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Yue-Peng', 'Initials': 'YP', 'LastName': 'An', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, 150040, Heilongjiang, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Dermatology, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Jin-Fang', 'Initials': 'JF', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Traditional Chinese Medicine Hospital of Shijiazhuang, Shijiahzuang, 050011, Hebei, China.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Sun', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. 13661956326@163.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. 18930568129@163.com.'}]",Trials,['10.1186/s13063-020-04691-7']
2319,32843086,"The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan.","OBJECTIVE


The purpose of this double-blind, randomised, placebo-controlled, adaptive design trial with frequent interim analyses is to determine if Australian Indigenous children, who receive an additional (third) dose of human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to < 12 months, would improve protection against clinically significant all-cause gastroenteritis.
PARTICIPANTS


Up to 1000 Australian Aboriginal and Torres Strait Islander (hereafter Indigenous) infants aged 6 to < 12 months will be recruited from all regions of the Northern Territory.
INTERVENTIONS


The intervention is the addition of a third scheduled dose of human monovalent rotavirus vaccine.
CO-PRIMARY AND SECONDARY OUTCOME MEASURES


ORVAC has two co-primary outcomes: (1) anti-rotavirus IgA seroconversion, defined as serum anti-rotavirus IgA ≥ 20 U/ml 28 to 55 days post Rotarix/placebo, and (2) time from randomisation to medical attendance for which the primary reason for presentation is acute gastroenteritis or acute diarrhoea illness before age 36 months. Secondary outcomes include (1) change in anti-rotavirus IgA log titre, (2) time from randomisation to hospitalisation with primary admission code presumed or confirmed acute diarrhoea illness before age 36 months, (3) time from randomisation to hospitalisation for which the admission is rotavirus confirmed diarrhoea illness before age 36 months and (4) time from randomisation to rotavirus infection (not necessarily requiring hospitalisation) meeting the jurisdictional definition before age 36 months.
DISCUSSION


A detailed, prospective statistical analysis plan is presented for this Bayesian adaptive design. The plan was written by the trial statistician and details the study design, pre-specified adaptative elements, decision thresholds, statistical methods and the simulations used to evaluate the operating characteristics of the trial. As at August 2020, four interim analyses have been run, but no stopping rules have been triggered. Application of this SAP will minimise bias and supports transparent and reproducible research.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02941107. Registered on 21 October 2016 ORIGINAL PROTOCOL FOR THE STUDY: https://doi.org/10.1136/bmjopen-2019-032549.",2020,"Secondary outcomes include (1) change in anti-rotavirus IgA log titre, (2) time from randomisation to hospitalisation with primary admission code presumed or confirmed acute diarrhoea illness before age 36 months, (3) time from randomisation to hospitalisation for which the admission is rotavirus confirmed diarrhoea illness before age 36 months and (4) time from randomisation to rotavirus infection (not necessarily requiring hospitalisation) meeting the jurisdictional definition before age 36 months.
","['Australian Indigenous children, who receive an additional (third) dose of', 'Australian Indigenous infants', 'Up to 1000 Australian Aboriginal and Torres Strait Islander (hereafter Indigenous) infants aged 6 to < 12 months will be recruited from all regions of the Northern Territory']","['placebo', 'human rotavirus vaccine (Rotarix, GlaxoSmithKline', 'Rotarix rotavirus vaccine']","['1) change in anti-rotavirus IgA log titre, (2) time from randomisation to hospitalisation with primary admission code presumed or confirmed acute diarrhoea illness before age 36 months, (3) time from randomisation to hospitalisation for which the admission is rotavirus confirmed diarrhoea illness', 'anti-rotavirus IgA seroconversion, defined as serum anti-rotavirus IgA ≥', 'protection against gastroenteritis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028416', 'cui_str': 'Northern Territory'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}]",,0.611032,"Secondary outcomes include (1) change in anti-rotavirus IgA log titre, (2) time from randomisation to hospitalisation with primary admission code presumed or confirmed acute diarrhoea illness before age 36 months, (3) time from randomisation to hospitalisation for which the admission is rotavirus confirmed diarrhoea illness before age 36 months and (4) time from randomisation to rotavirus infection (not necessarily requiring hospitalisation) meeting the jurisdictional definition before age 36 months.
","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Jones', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteUniversity of Western Australia, Perth, 6009, WA, Australia. mark.jones@telethonkids.org.au.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Graves', 'Affiliation': 'Berry Consultants, 3345 Bee Caves Rd Suite 201, Austin, 78746, TX, USA.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Middleton', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Rocklands Drive, Casuarina, 0811, NT, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Totterdell', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteUniversity of Western Australia, Perth, 6009, WA, Australia.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Snelling', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteUniversity of Western Australia, Perth, 6009, WA, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Marsh', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteUniversity of Western Australia, Perth, 6009, WA, Australia.'}]",Trials,['10.1186/s13063-020-04602-w']
2320,32843098,High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The aim of this study is to explore the effectiveness and safety of high dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to SARS-Cov-2 pneumonia.
TRIAL DESIGN


Multicentre, randomized clinical trial, controlled, open label, parallel group, to evaluate the effectiveness and safety of high dose dexamethasone in adult patients with confirmed COVID-19, with Acute Respiratory Distress Syndrome.
PARTICIPANTS


We will include patients with SARS-Cov-2 pneumonia who develop acute respiratory distress syndrome, in several intensive care units (ICU) in Buenos Aires, Argentina (CEMIC, Clinica Bazterrica, Sanatorio Sagrado Corazon) Inclusion criteria: Men and women, age ≥ 18 years old. Confirmed diagnosis of SARS-CoV-2 infection, by RT-PCR. Diagnosis of Acute Respiratory Distress Syndrome (hypoxemic respiratory failure not explained by cardiac disease + PaO 2 /FiO 2  ratio < 300 with a Positive End-Expiratory Pressure ≥ 5 cm H 2 O + bilateral pulmonary infiltrates) Length of mechanical ventilation of at least 72 hours Informed consent (next of kin / legal guardian) Exclusion criteria: Pregnant or breast-feeding women. Terminal disease (advanced cancer; under palliative care; cardiovascular, respiratory, or renal disease with a life expectancy less ≤ 1 year). Therapeutic limitation (advance directives or do not resuscitate order) Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents, active cancer). Patients under chronic treatment with glucocorticoids for other diseases (≥ 8 mg prednisone, or equivalent) Participation in another randomized clinical trial.
INTERVENTION AND COMPARATOR


Eligible patients will be randomized to receive standard ICU patient care (group 1) or standard ICU patient care plus high dose dexamethasone (group 2). Group 1: dexamethasone up to 6 mg/24 hours for up to 10 days + ventilatory, hemodynamic, nutritional, and antimicrobial support according to international guidelines. Group 2: dexamethasone 16 mg/24 hours for 5 days followed by dexamethasone 8 mg/24 hours for 5 days + ventilatory, hemodynamic, nutritional, and antimicrobial support according to international guidelines.
MAIN OUTCOME


The main result is ventilator-free days at 28 days (Days without ventilator support in the first 28 days following randomization). Secondary outcomes are 28-days and 90-days mortality, frequency of nosocomial infections in the first 28 days after randomization, Sequential Organ Failure Assessment (SOFA) score variation and prone position in the first 10-days, viral shedding 28-days after randomization, and delirium and muscle weakness at ICU discharge.
RANDOMISATION


Treatment will be assigned according to site stratified randomization by permuted random blocks sequence 1:1 generated with a table in R language concealed in a randomization tool in REDCap (Research Electronic Data CAPture) platform.
BLINDING (MASKING)


This is an open trial, so no masking of treatment assignment will be used.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Assuming a 3 days difference in ventilator-free days between treatment groups, with a mean of 9 days, and a standard deviation of 9 days; the necessary sample size would be 284 subjects (142 per group), with a power of 80% and a two-tailed alpha error of 0.05.
TRIAL STATUS


The protocol with code 1264, version 3.0 on date: May 13, 2020 is approved by the local Ethics Committee. The trial is in the recruitment phase. Recruitment began May 22, 2020 and is anticipated to be complete by the end of December 2021.
TRIAL REGISTRATION


The trial was registered under the title ""Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial"" with ClinicalTrials number NCT04395105, https://clinicaltrials.gov/ct2/show/NCT04395105 , registered on 20 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary outcomes are 28-days and 90-days mortality, frequency of nosocomial infections in the first 28 days after randomization, Sequential Organ Failure Assessment (SOFA) score variation and prone position in the first 10-days, viral shedding 28-days after randomization, and delirium and muscle weakness at ICU discharge.
","['Terminal disease (advanced cancer; under palliative care; cardiovascular, respiratory, or renal disease with a life expectancy less ≤ 1 year', 'Acute Respiratory Distress Syndrome secondary to SARS-Cov-2 pneumonia', '2 O + bilateral pulmonary infiltrates', 'Men and women, age ≥ 18 years old', 'patients with SARS-Cov-2 pneumonia who develop acute respiratory distress syndrome, in several intensive care units (ICU) in Buenos Aires, Argentina (CEMIC, Clinica Bazterrica, Sanatorio Sagrado Corazon', 'adult patients with confirmed COVID-19, with Acute Respiratory Distress Syndrome', 'Inclusion criteria', 'Acute Respiratory Distress Syndrome secondary to COVID-19', 'Patients under chronic treatment with glucocorticoids for other diseases (≥ 8 mg prednisone, or equivalent) Participation in another randomized clinical trial']","['dexamethasone', 'dexamethasone 16', 'standard ICU patient care (group 1) or standard ICU patient care plus high dose dexamethasone']","['Length of mechanical ventilation', 'effectiveness and safety', '28-days and 90-days mortality, frequency of nosocomial infections in the first 28 days after randomization, Sequential Organ Failure Assessment (SOFA) score variation and prone position in the first 10-days, viral shedding 28-days after randomization, and delirium and muscle weakness at ICU discharge']","[{'cui': 'C0679247', 'cui_str': 'Terminal illness'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1741275', 'cui_str': 'AIRE protein, human'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.333972,"Secondary outcomes are 28-days and 90-days mortality, frequency of nosocomial infections in the first 28 days after randomization, Sequential Organ Failure Assessment (SOFA) score variation and prone position in the first 10-days, viral shedding 28-days after randomization, and delirium and muscle weakness at ICU discharge.
","[{'ForeName': 'Luis Patricio', 'Initials': 'LP', 'LastName': 'Maskin', 'Affiliation': 'Intensive Care Unit, CEMIC, Buenos Aires, Argentina. pmaskin@cemic.edu.ar.'}, {'ForeName': 'Gabriel Leonardo', 'Initials': 'GL', 'LastName': 'Olarte', 'Affiliation': 'Intensive Care Unit, Sanatorio Sagrado Corazon, Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Palizas', 'Affiliation': 'Intensive Care Unit, Clinica Bazterrica, Buenos Aires, Argentina.'}, {'ForeName': 'Agostina E', 'Initials': 'AE', 'LastName': 'Velo', 'Affiliation': 'Intensive Care Unit, CEMIC, Buenos Aires, Argentina.'}, {'ForeName': 'María Fernanda', 'Initials': 'MF', 'LastName': 'Lurbet', 'Affiliation': 'Intensive Care Unit, CEMIC, Buenos Aires, Argentina.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bonelli', 'Affiliation': 'Intensive Care Unit, CEMIC, Buenos Aires, Argentina.'}, {'ForeName': 'Natalio D', 'Initials': 'ND', 'LastName': 'Baredes', 'Affiliation': 'Intensive Care Unit, Sanatorio Sagrado Corazon, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo Oscar', 'Initials': 'PO', 'LastName': 'Rodríguez', 'Affiliation': 'Intensive Care Unit, CEMIC, Buenos Aires, Argentina. prodriguez@cemic.edu.ar.'}]",Trials,['10.1186/s13063-020-04646-y']
2321,32843108,FAST Performance in a Stationary versus In-Motion Military Ambulance Utilizing Handheld Ultrasound: A Randomized Controlled Study.,"OBJECTIVE


On-scene prehospital conditions and patient instability may warrant a during-transport ultrasound (US) exam. The objective of this study was to assess the effect of ambulance turbulence on the performance of the Focused Assessment with Sonography in Trauma (FAST) with a handheld US device.
METHODS


This was a randomized controlled trial in which participants were randomized to perform a FAST in either a stationary or an in-motion military ambulance. Participants were physicians and physician assistants (PAs) with previous FAST training. All exams were performed on an US phantom model. The primary outcome was FAST completion time, reported as a mean, in seconds. Secondary outcomes included image acquisition score (range of 0-24, reported as a mean), diagnostic accuracy (reported as sensitivity and specificity), and a post-participation survey with five-item Likert-type scales.
RESULTS


Twenty-seven participants performed 27 FASTs, 14 in the stationary ambulance and 13 in the in-motion ambulance. All participants obtained the four requisite views of the FAST. A significant difference was detected in image acquisition scores in favor of the stationary ambulance group (19.4 versus 16.7 [95% CI for difference, 0.9-4.4]; P <.01). Significant differences in survey items between groups were related to obtaining and maintaining US images and the exam conditions. There was not a difference in FAST completion time between groups (98.5 seconds versus 78.7 seconds [95% CI for difference, -13.5 seconds to 53.1 seconds]; P = .23). Sensitivity and specificity of FAST in the stationary ambulance was 85.7% (95% CI, 67.3%-96.0%) and 96.4% (95% CI, 81.7%-99.9%) versus 96.2% (95% CI, 80.4%-99.9%) and 100.0% (95% CI, 86.8%-100.0%) in the in-motion ambulance group (P = .21).
CONCLUSION


Vehicular motion did not affect FAST completion time and diagnostic accuracy; however, it did reduce FAST image acquisition scores. The results suggest timely and diagnostically accurate FASTs may be completed by experienced sonographers during moderate levels of ambulance turbulence. Further investigation assessing the utility and limitations of newer handheld US devices in various prehospital conditions is warranted.",2020,"There was not a difference in FAST completion time between groups (98.5 seconds versus 78.7 seconds [95% CI for difference, -13.5 seconds to 53.1 seconds]; P = .23).","['Twenty-seven participants performed 27 FASTs, 14 in the stationary ambulance and 13 in the in-motion ambulance', 'Participants were physicians and physician assistants (PAs) with previous FAST training']","['Handheld Ultrasound', 'FAST']","['FAST completion time and diagnostic accuracy', 'FAST Performance', 'image acquisition scores', 'FAST image acquisition scores', 'image acquisition score (range of 0-24, reported as a mean), diagnostic accuracy (reported as sensitivity and specificity), and a post-participation survey with five-item Likert-type scales', 'FAST completion time', 'Sensitivity and specificity of FAST']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",27.0,0.167557,"There was not a difference in FAST completion time between groups (98.5 seconds versus 78.7 seconds [95% CI for difference, -13.5 seconds to 53.1 seconds]; P = .23).","[{'ForeName': 'Cecil J', 'Initials': 'CJ', 'LastName': 'Simmons', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, Joint Base Lewis-McChord, WashingtonUSA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Mack', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, Joint Base Lewis-McChord, WashingtonUSA.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Cronin', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, Joint Base Lewis-McChord, WashingtonUSA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Monti', 'Affiliation': 'Department of Clinical Investigation, Madigan Army Medical Center, Joint Base Lewis-McChord, WashingtonUSA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Perreault', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, Joint Base Lewis-McChord, WashingtonUSA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ahern', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, Joint Base Lewis-McChord, WashingtonUSA.'}]",Prehospital and disaster medicine,['10.1017/S1049023X20001028']
2322,32843164,"Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON).","BACKGROUND


The efficacy and safety of once-daily (o.d.) fixed-dose combination of indacaterol (IND), glycopyrronium (GLY) and mometasone furoate (MF) via Breezhaler® versus concurrent administration of salmeterol/fluticasone (SAL/FLU) twice-daily (b.i.d.) via Accuhaler®+Tiotropium (TIO) o.d. via Respimat® was evaluated in patients with uncontrolled asthma.
METHODS


Patients (aged ≥18 years), symptomatic (Asthma Control Questionnaire [ACQ]-7 ≥1.5) despite treatment with long-acting β 2 -agonist/inhaled corticosteroid medium- or high-dose, received IND/GLY/MF high- (150/50/160 μg) or medium-dose (150/50/80 μg) o.d. or SAL/FLU high-dose (50/500 μg) b.i.d.+Tio 5 μg o.d. for 24 weeks. The primary objective was to confirm the non-inferiority of either dose of IND/GLY/MF to SAL/FLU high dose + TIO in terms of Asthma Quality of Life Questionnaire (AQLQ). Additional endpoints: ACQ-7, lung function, health status (St George's Respiratory Questionnaire [SGRQ]), exacerbations, and safety after 24 weeks.
RESULTS


IND/GLY/MF high- and medium-dose met the primary endpoint, confirming non-inferiority to SAL/FLU high dose + TIO for AQLQ (least square mean treatment difference [Δ]: 0.073 and -0.038, respectively; both p < 0.001). IND/GLY/MF high-dose improved ACQ-7 (Δ: -0.124; p = 0.004), trough FEV 1  (Δ: 96 mL; p < 0.001), peak expiratory flow (morning [Δ: 9.56 L/min; p = 0.005], evening [Δ: 9.15 L/min; p = 0.006]) and SGRQ (Δ: -2.00; p = 0.04) versus SAL/FLU high dose + TIO. Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO. Adverse events were generally comparable across treatments.
CONCLUSIONS


IND/GLY/MF high- and medium-dose o.d. via a single inhaler were non-inferior to SAL/FLU high-dose b.i.d. + TIO o.d. via two inhalers for AQLQ. IND/GLY/MF high-dose o.d. improved lung function, asthma control and health status versus SAL/FLU high dose + TIO, while IND/GLY/MF medium-dose had comparable efficacy but at a corresponding lower steroid dose.",2020,Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO.,"['Patients (aged ≥18 years), symptomatic (Asthma Control Questionnaire [ACQ]-7 ≥1.5) despite treatment with long-acting β 2 -agonist/inhaled corticosteroid medium- or high-dose, received IND/GLY/MF high', 'patients with uncontrolled asthma']","['indacaterol/glycopyrronium/mometasone furoate', 'salmeterol/fluticasone twice-daily plus tiotropium', 'indacaterol (IND), glycopyrronium (GLY) and mometasone furoate (MF) via Breezhaler®', 'salmeterol/fluticasone (SAL/FLU) twice-daily (b.i.d.) via Accuhaler®+Tiotropium (TIO', 'b.i.d.+Tio 5\xa0μg']","['Asthma Quality of Life Questionnaire (AQLQ', 'Adverse events', 'GLY/MF high-dose improved ACQ-7', ""ACQ-7, lung function, health status (St George's Respiratory Questionnaire [SGRQ]), exacerbations, and safety after 24 weeks"", 'peak expiratory flow', 'improved lung function, asthma control and health status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.202799,Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany. Electronic address: studien@pois-le.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kornmann', 'Affiliation': 'IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Salina', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pritam', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bostel', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Lorena Garcia', 'Initials': 'LG', 'LastName': 'Conde', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pfister', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106021']
2323,32843241,Impacts of a Cash Plus Intervention on Gender Attitudes Among Tanzanian Adolescents.,"PURPOSE


Inequitable attitudes toward men's and women's roles, rights, and responsibilities are associated with poor health-related outcomes, particularly for girls and women. Yet, we know relatively little about what interventions work to improve gender-equitable attitudes among adolescents in low-income countries. This study examines the impact of a government-implemented ""cash plus"" intervention on gender-equitable attitudes among adolescents in Tanzania. The intervention includes discussions and activities related to gender norms, embedded in broader life skills, livelihoods, and health training.
METHODS


The study utilizes a cluster randomized design, using data from 1,933 males and females aged 14-19 years at baseline who took part in the baseline (2017), midline (2018), and endline (2019) surveys. Gender attitudes were measured using 24 items from the Gender-Equitable Men (GEM) Scale. We estimate intent-to-treat impacts on the GEM scale and four subscales (violence, sexual relationships, reproductive health, and domestic chores).
RESULTS


The ""cash plus"" intervention had a significant impact on the overall GEM scale at midline. The intervention increased gender-equitable attitudes on the domestic chores subscale at both midline and endline. The intervention improved gender-equitable attitudes among males on the overall GEM scale and three subscales at midline and on two subscales at endline, but it had no impacts among females.
CONCLUSIONS


Gender transformative social protection is currently being advocated as a way to address the gendered nature of poverty and its consequences. Initiatives such as the one studied here, which address the multifaceted drivers of gender inequities, could be a promising way forward.",2020,"The intervention improved gender-equitable attitudes among males on the overall GEM scale and three subscales at midline and on two subscales at endline, but it had no impacts among females.
","['adolescents in Tanzania', 'Tanzanian Adolescents', '1,933 males and females aged 14-19 years at baseline who took part in the baseline (2017), midline (2018), and endline (2019) surveys']","['Cash Plus Intervention', 'government-implemented ""cash plus"" intervention']","['Gender Attitudes', 'GEM scale and four subscales (violence, sexual relationships, reproductive health, and domestic chores', 'gender-equitable attitudes', 'Gender attitudes', 'overall GEM scale']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0147664,"The intervention improved gender-equitable attitudes among males on the overall GEM scale and three subscales at midline and on two subscales at endline, but it had no impacts among females.
","[{'ForeName': 'Yekaterina', 'Initials': 'Y', 'LastName': 'Chzhen', 'Affiliation': 'Department of Sociology, Trinity College Dublin, Dublin, Ireland. Electronic address: chzheny@tcd.ie.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Prencipe', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eetaama', 'Affiliation': 'Children and AIDS Section, UNICEF Tanzania, Dar es Salaam, Tanzania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Luchemba', 'Affiliation': 'Tanzania Social Action Fund, United Republic of Tanzania, Dodoma, Tanzania.'}, {'ForeName': 'Tumpe Mnyawami', 'Initials': 'TM', 'LastName': 'Lukongo', 'Affiliation': 'Tanzania Social Action Fund, United Republic of Tanzania, Dodoma, Tanzania.'}, {'ForeName': 'Tia', 'Initials': 'T', 'LastName': 'Palermo', 'Affiliation': 'Department of Epidemiology and Environmental Health, State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.025']
2324,32843244,"Re: Hiten D. Patel, Farzana A. Faisal, Bruce J. Trock, et al. Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.05.001.",,2020,,[],"['Radical Prostatectomy', 'Pharmacologic Prophylaxis']",['Venous Thromboembolism'],[],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.0420262,,"[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Nocera', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montreal Health Center, Montreal, Canada; Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: nocera.luigi@hsr.it.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Pierre I', 'Initials': 'PI', 'LastName': 'Karakiewicz', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montreal Health Center, Montreal, Canada.'}]",European urology,['10.1016/j.eururo.2020.08.012']
2325,32843260,Analyzing Longitudinal Data on Singing Voice Parameters of Boys and Girls Aged 8 to 12.5 and Possible Effects of a Music Pedagogical Intervention.,"OBJECTIVE


Controlled and randomized study to analyze longitudinal voice data of boys and girls aged 8-12.5, to describe their physiological development and to evaluate the influence of a one-year music pedagogical interventional program focused on the singing voice.
METHODS


Singing voice profiles of 116 children (52 boys, 64 girls) aged 8-12.5 years were collected longitudinally at the beginning and the end of the third school year and the end of the fourth school year. 64 of the 116 children received a music pedagogical program during their third school year (interventional group). Maximum and minimum voice intensity, highest and lowest frequency, maximum phonation time (MPT) and Jitter were investigated.
RESULTS


In two years' time highest frequency increased on average by 100.23 Hz from G1 up to A1 for boys and for girls. Lowest frequency decreased by 18.36Hz from Gis-1 to G-1 (boys: Gis-1-Fis-1; girls: A-1-G-1). There was no clinically relevant development of the intensity parameters for both sexes. However, after the interventional year, minimum voice intensity significantly decreased in the interventional group compared to the control group. The MPT increased by 2.41 seconds from 10.67 seconds up to 13.09 seconds in two years. Here the increase was higher for boys (+3.2 seconds) than for girls (+1.77 seconds). Jitter was found to be 0.84%-1.11%, showing no clinically relevant changes in two years.
CONCLUSION


To the best of our knowledge, for the first time this study presents longitudinal data on singing voice parameters of the voice range profile of boys and girls aged 8-12.5 years. While frequency and intensity parameters develop equally for boys and girls, the MPT is found to develop more distinctly within boys. A music pedagogical intervention of a small extent has a positive effect on the ability to sing as soft as possible.",2020,In two years' time highest frequency increased on average by 100.23 Hz from G1 up to A1 for boys and for girls.,"['Boys and Girls Aged 8 to 12.5', '64 of the 116 children', 'boys and girls aged 8-12.5 years', 'Singing voice profiles of 116 children (52 boys, 64 girls) aged 8-12.5 years were collected longitudinally at the beginning and the end of the third school year and the end of the fourth school year', 'boys and girls aged 8-12.5']","['music pedagogical program', 'Music Pedagogical Intervention']","['MPT', 'minimum voice intensity', 'Maximum and minimum voice intensity, highest and lowest frequency, maximum phonation time (MPT) and Jitter', 'Lowest frequency']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]",116.0,0.0318872,In two years' time highest frequency increased on average by 100.23 Hz from G1 up to A1 for boys and for girls.,"[{'ForeName': 'Lennart Heinrich', 'Initials': 'LH', 'LastName': 'Pieper', 'Affiliation': 'Department of Otorhinolaryngology, Section of Phoniatrics and Audiology, University of Leipzig, 04103 Leipzig, Germany. Electronic address: LennartHeinrich.Pieper@medizin.uni-leipzig.de.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Körner', 'Affiliation': 'Clinic of Otorhinolaryngology, HELIOS Hospital Aue, 08280 Aue, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Wiedemann', 'Affiliation': 'School of Music Musikschule Leipzig ""Johann Sebastian Bach"", 04109 Leipzig, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ludwig', 'Affiliation': 'Department of Otorhinolaryngology, Section of Phoniatrics and Audiology, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Werner', 'Affiliation': 'Department of Otorhinolaryngology, Section of Phoniatrics and Audiology, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Sylvi', 'Initials': 'S', 'LastName': 'Meuret', 'Affiliation': 'Department of Otorhinolaryngology, Section of Phoniatrics and Audiology, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Department of Otorhinolaryngology, Section of Phoniatrics and Audiology, University of Leipzig, 04103 Leipzig, Germany.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.07.012']
2326,32786187,Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia.,"BACKGROUND


Older patients with acute myeloid leukemia (AML) have a dismal prognosis, even after treatment with a hypomethylating agent. Azacitidine added to venetoclax had promising efficacy in a previous phase 1b study.
METHODS


We randomly assigned previously untreated patients with confirmed AML who were ineligible for standard induction therapy because of coexisting conditions, because they were 75 years of age or older, or both to azacitidine plus either venetoclax or placebo. All patients received a standard dose of azacitidine (75 mg per square meter of body-surface area subcutaneously or intravenously on days 1 through 7 every 28-day cycle); venetoclax (target dose, 400 mg) or matching placebo was administered orally, once daily, in 28-day cycles. The primary end point was overall survival.
RESULTS


The intention-to-treat population included 431 patients (286 in the azacitidine-venetoclax group and 145 in the azacitidine-placebo [control] group). The median age was 76 years in both groups (range, 49 to 91). At a median follow-up of 20.5 months, the median overall survival was 14.7 months in the azacitidine-venetoclax group and 9.6 months in the control group (hazard ratio for death, 0.66; 95% confidence interval, 0.52 to 0.85; P<0.001). The incidence of complete remission was higher with azacitidine-venetoclax than with the control regimen (36.7% vs. 17.9%; P<0.001), as was the composite complete remission (complete remission or complete remission with incomplete hematologic recovery) (66.4% vs. 28.3%; P<0.001). Key adverse events included nausea of any grade (in 44% of the patients in the azacitidine-venetoclax group and 35% of those in the control group) and grade 3 or higher thrombocytopenia (in 45% and 38%, respectively), neutropenia (in 42% and 28%), and febrile neutropenia (in 42% and 19%). Infections of any grade occurred in 85% of the patients in the azacitidine-venetoclax group and 67% of those in the control group, and serious adverse events occurred in 83% and 73%, respectively.
CONCLUSIONS


In previously untreated patients who were ineligible for intensive chemotherapy, overall survival was longer and the incidence of remission was higher among patients who received azacitidine plus venetoclax than among those who received azacitidine alone. The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group. (Funded by AbbVie and Genentech; VIALE-A ClinicalTrials.gov number, NCT02993523.).",2020,The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group.,"['Previously Untreated Acute Myeloid Leukemia', 'untreated patients with confirmed AML who were ineligible for standard induction therapy because of coexisting conditions, because they were 75 years of age or older, or both to', 'Older patients with acute myeloid leukemia (AML', 'The median age was 76 years in both groups (range, 49 to 91', '431 patients (286 in the azacitidine-venetoclax group and 145 in the']","['azacitidine plus venetoclax', 'azacitidine', 'venetoclax (target dose, 400 mg) or matching placebo', 'Azacitidine', 'venetoclax', 'Azacitidine and Venetoclax', 'azacitidine-venetoclax', 'azacitidine-placebo [control', 'venetoclax-azacitidine', 'azacitidine plus either venetoclax or placebo']","['incidence of complete remission', 'febrile neutropenia', 'neutropenia', 'Infections of any grade', 'overall survival', 'incidence of febrile neutropenia', 'serious adverse events', 'median overall survival', 'nausea of any grade', 'grade 3 or higher thrombocytopenia', 'incidence of remission', 'composite complete remission (complete remission or complete remission with incomplete hematologic recovery']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}]",431.0,0.348327,The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group.,"[{'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Jonas', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Pullarkat', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thirman', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Garcia', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Konopleva', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Letai', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Havelange', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Esteve', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Vlatko', 'Initials': 'V', 'LastName': 'Pejsa', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Porkka', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lavie', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Roberto M', 'Initials': 'RM', 'LastName': 'Lemoli', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Su-Peng', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Turgut', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Wan-Jen', 'Initials': 'WJ', 'LastName': 'Hong', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jalaja', 'Initials': 'J', 'LastName': 'Potluri', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Pratz', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}]",The New England journal of medicine,['10.1056/NEJMoa2012971']
2327,32837953,CREATE (Community deRivEd AutomaTEd insulin delivery) trial. Randomised parallel arm open label clinical trial comparing automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy in type 1 diabetes.,"Background


Commercialised automated insulin delivery (AID) systems have demonstrated improved outcomes in type 1 diabetes (T1D), however, they have limited capacity for algorithm individualisation, and can be prohibitively expensive if an individual is without access to health insurance or health funding subsidy. Freely available open-source algorithms, which have the ability to individualise algorithm parameters paired with commercial insulin pumps, and continuous glucose monitoring make up the so-called ""do it yourself"" (DIY) approach to AID. Limited data on the open-source approach have shown promising results, but data from a large randomised control trial are lacking.
Methods


The CREATE (Community deRivEd AutomaTEd insulin delivery) trial is an open-labelled, randomised, parallel 24-week, multi-site trial comparing sensor augmented pump therapy (SAPT) to our AnyDANA-loop. The three components of AnyDANA-loop are: 1) OpenAPS algorithm implemented in a smartphone (a version of AndroidAPS), 2) DANA-i™ insulin pump and, 3) Dexcom G6 R  continuous glucose monitor (CGM). The primary outcome measure is the percentage of time in target sensor glucose range (3.9 -10mmol/L). Secondary outcomes include psycho-social factors and platform performance. Analysis of online collective learning, characteristic of the open-source approach, is planned. 100 participants with T1D aged 7 - 70 years (age stratified into children/adolescents 7-15 years and adults 16-70 years), will be recruited from four sites in New Zealand. A 24-week continuation phase follows, to assess long-term safety.",2020,"Background


Commercialised automated insulin delivery (AID) systems have demonstrated improved outcomes in type 1 diabetes (T1D), however, they have limited capacity for algorithm individualisation, and can be prohibitively expensive if an individual is without access to health insurance or health funding subsidy.","['100 participants with T1D aged 7 - 70 years (age stratified into children/adolescents 7-15 years and adults 16-70 years', 'type 1 diabetes']","['automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy', 'smartphone (a version of AndroidAPS), 2) DANA-i™ insulin pump and, 3) Dexcom G6 R  continuous glucose monitor (CGM', 'sensor augmented pump therapy (SAPT', '\n\n\nCommercialised automated insulin delivery (AID) systems']","['psycho-social factors and platform performance', 'percentage of time in target sensor glucose range (3.9 -10mmol/L']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0337460', 'cui_str': 'Social factor'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517698', 'cui_str': '3.9'}]",100.0,0.196103,"Background


Commercialised automated insulin delivery (AID) systems have demonstrated improved outcomes in type 1 diabetes (T1D), however, they have limited capacity for algorithm individualisation, and can be prohibitively expensive if an individual is without access to health insurance or health funding subsidy.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Burnside', 'Affiliation': 'Department of Paediatrics, University of Otago, 2 Riccarton Avenue, Christchurch, 8011 New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'OpenAPS, Seattle, WA USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Crocket', 'Affiliation': 'Te Huataki Waiora School of Health, Sport & Human Performance, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Department of Paediatrics, University of Otago, 2 Riccarton Avenue, Christchurch, 8011 New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Williman', 'Affiliation': 'Department of Population Health, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jefferies', 'Affiliation': ""Department of Paediatric Endocrinology, Starship Children's Hospital, Auckland District Health Board, Auckland, New Zealand.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Waikato Regional Diabetes Service, Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, 2 Riccarton Avenue, Christchurch, 8011 New Zealand.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00547-8']
2328,32838052,Application of randomization techniques for balancing site covariates in the adult day service plus pragmatic cluster-randomized trial.,"Cluster-randomized trials (CRTs) are increasingly common in pragmatic trials of interventions for older adults, where staff of existing clinics or service agencies deliver interventions. The Adult Day Service (ADS) Plus intervention is delivered by trained staff at adult day service facilities to assist older adults with cognitive impairments and their family caregivers. Because sizable imbalances on important site characteristics might emerge from a simple randomization, we implemented a 3-stage constrained randomization approach to limit imbalance between intervention and usual care control conditions on 5 site characteristics: capacity; % of minority clients; % of clients with dementia; urban, rural or suburban location; and private or public ownership. In stage 1, the Balance Match Weighted (BMW) re-randomization procedure was used to assign 30 sites to ADS Plus or control arms based on the best randomization out of 20 total randomization for minimizing site imbalance. In stage 2, propensity scores from the BMW logistic regression analysis for reserve sites were used to determine substitutions for randomized sites that opted out of the CRT prior to implementation. In stage 3, a minimization approach was used to add 20 more sites to the trial. A standardized metric based on the half-normal distribution of the absolute value of mean differences was used to assess site imbalance. After stage 3, the remaining imbalance for the 49 enrolled sites was reduced by 75% from what would have been expected from a simple randomization. Optimized randomization procedures with similar imbalance metrics should be used more routinely in pragmatic CRTs.",2020,Plus intervention is delivered by trained staff at adult day service facilities to assist older adults with cognitive impairments and their family caregivers.,"['older adults', 'minority clients; % of clients with dementia; urban, rural or suburban location; and private or public ownership', 'older adults with cognitive impairments and their family caregivers']",[],['Adult Day Service (ADS'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0833573,Plus intervention is delivered by trained staff at adult day service facilities to assist older adults with cognitive impairments and their family caregivers.,"[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Center on Aging and Health, Division of Geriatric Medicine and Gerontology, 2024 East Monument Street, Johns Hopkins University, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center on Aging and Health, Division of Geriatric Medicine and Gerontology, 2024 East Monument Street, Johns Hopkins University, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, 1601 Cherry Street, Mail Stop 10501, Drexel University, Philadelphia, PA, 19102, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Gaugler', 'Affiliation': 'Division of Health Policy and Management, School of Public Health, 420 Delaware St. SE, University of Minnesota, Minneapolis, MN, 55455, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100628']
2329,32838109,STudy of Alteplase for Respiratory failure in SARS-Cov2/COVID-19: Study Design of the Phase IIa STARS Trial.,"Background


The COVID-19 pandemic has caused a large surge of acute respiratory distress syndrome (ARDS). Prior phase I trials (non COVID-19) demonstrated improvement in pulmonary function in ARDS patients using fibrinolytic therapy. A follow-up trial using the widely available tissue-plasminogen activator (alteplase) is now needed to assess optimal dosing and safety in this critically ill patient population.
Objective


To describe the design and rationale of a Phase IIa trial to evaluate the safety and efficacy of alteplase treatment for moderate/severe COVID-19-induced ARDS.
Patients/Methods


A rapidly adaptive, pragmatic, open label, randomized, controlled, phase IIa clinical trial will be conducted with three groups: intravenous(IV) alteplase 50mg, IV alteplase 100mg, and control (standard-of-care). Inclusion criteria are known/suspected COVID-19 infection with PaO2/FiO2 ratio<150mmHg for >4 hours despite maximal mechanical ventilation management. Alteplase will be delivered through an initial bolus of 50mg or 100mg followed by heparin infusion for systemic anticoagulation, with alteplase re-dosing if there is a >20% PaO2/FiO2 improvement not sustained by 24 hours.
Results


The primary outcome is improvement in PaO2/FiO2 at 48 hours post-randomization. Other outcomes include: ventilator- and ICU-free-days, successful extubation (no reintubation ≤3 days after initial extubation), and mortality. Fifity eligible patients will be enrolled in a rapidly adaptive, modified stepped-wedge design with four looks at the data.
Conclusion


Findings will provide timely information on the safety, efficacy and optimal dosing of tPA to treat moderate/severe COVID-19-induced ARDS, which can be rapidly adapted to a phase III trial. (NCT04357730; FDA IND 149634).",2020,"PaO2/FiO2 improvement not sustained by 24 hours.
","['Fifity eligible patients will be enrolled in a rapidly adaptive, modified stepped-wedge design with four looks at the data', 'critically ill patient population']","['fibrinolytic therapy', 'heparin infusion', 'Alteplase', 'tissue-plasminogen activator (alteplase', 'alteplase 50mg, IV alteplase 100mg, and control (standard-of-care']","['ventilator- and ICU-free-days, successful extubation (no reintubation ≤3 days after initial extubation), and mortality', 'improvement in PaO2/FiO2', 'safety and efficacy', 'pulmonary function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",,0.26907,"PaO2/FiO2 improvement not sustained by 24 hours.
","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery University of Colorado Denver School of Medicine Aurora CO USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Barrett', 'Affiliation': 'Koch Institute for Integrative Cancer Research Center for Precision Cancer Medicine Departments of Biological Engineering and Biology Massachusetts Institute of Technology Cambridge MA USA.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery University of Colorado Denver School of Medicine Aurora CO USA.'}, {'ForeName': 'Rashi', 'Initials': 'R', 'LastName': 'Jhunjhnuwala', 'Affiliation': 'Division of Acute Care Surgery, Trauma and Surgical Critical Care Department of Surgery Beth Israel Deaconess Medical Center Harvard Medical School Boston MA USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'McIntyre', 'Affiliation': 'Department of Surgery University of Colorado Denver School of Medicine Aurora CO USA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Moore', 'Affiliation': 'Department of Medicine University of Colorado Denver School of Medicine Colorado USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Feinstein Institutes for Medical Research Northwell Health Manhasset NY USA.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Hajizadeh', 'Affiliation': 'Feinstein Institutes for Medical Research Northwell Health Manhasset NY USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Talmor', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine Beth Israel Deaconess Medical Center Harvard Medical School Boston MA USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'Department of Surgery University of Colorado Denver School of Medicine Aurora CO USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Yaffe', 'Affiliation': 'Koch Institute for Integrative Cancer Research Center for Precision Cancer Medicine Departments of Biological Engineering and Biology Massachusetts Institute of Technology Cambridge MA USA.'}]",Research and practice in thrombosis and haemostasis,['10.1002/rth2.12395']
2330,32838238,A clinical pilot study on the safety and efficacy of aerosol inhalation treatment of IFN-κ plus TFF2 in patients with moderate COVID-19.,"Background


The outbreak of a new coronavirus (SARS-CoV-2) poses a great challenge to global public health. New and effective intervention strategies are urgently needed to combat the disease.
Methods


We conducted an open-label, non-randomized, clinical trial involving moderate COVID-19 patients according to study protocol. Patients were assigned in a 1:2 ratio to receive either aerosol inhalation treatment with IFN-κ and TFF2, every 48 h for three consecutive dosages, in addition to standard treatment (experimental group), or standard treatment alone (control group). The end point was the time to discharge from the hospital. This study is registered with chictr.org.cn, ChiCTR2000030262.
Findings


A total of thirty-three eligible COVID-19 patients were enrolled from February 1, 2020 to April 6, 2020, eleven were assigned to the IFN-κ plus TFF2 group, and twenty-two to the control group. Safety and efficacy were evaluated for both groups. No treatment-associated severe adverse effects (SAE) were observed in the group treated with aerosol inhalation of IFN-κ plus TFF2, and no significant differences in the safety evaluations were observed between experimental and control groups. CT imaging was performed in all patients with the median improvement time of 5 . 0 days (IQR 3 . 0-9 . 0) in the experimental group versus 8 . 5 days (IQR 3 . 0-17 . 0) in the control group ( p <0 . 05). In addition, the experimental group had a significant shorten median time in cough relief (4 . 5 days [IQR 2 . 0-7 . 0]) than the control group did (10 . 0 days [IQR 6 . 0-21 . 0])( p <0 . 005), in viral RNA reversion of 6 . 0 days (IQR 2 . 0-13 . 0) in the experimental group vs 9.5 days (IQR 3 . 0-23 . 0) in the control group ( p  < 0 . 05), and in the median hospitalization stays of 12 . 0 days (IQR 7.0-20.0) in the experimental group vs 15 . 0 days (IQR 10.0-25.0) in the control group ( p <0 . 001), respectively.
Interpretation


Aerosol inhalation of IFN-κ plus TFF2 is a safe treatment and is likely to significantly facilitate clinical improvement, including cough relief, CT imaging improvement, and viral RNA reversion, thereby achieves an early release from hospitalization. These data support to explore a scale-up trial with IFN-κ plus TFF2.
Funding


National Major Project for Control and Prevention of Infectious Disease in China, Shanghai Science and Technology Commission, Shanghai Municipal Health Commission.",2020,"No treatment-associated severe adverse effects (SAE) were observed in the group treated with aerosol inhalation of IFN-κ plus TFF2, and no significant differences in the safety evaluations were observed between experimental and control groups.","['A total of thirty-three eligible COVID-19 patients were enrolled from February 1, 2020 to April 6, 2020, eleven were assigned to the', 'patients with moderate COVID-19']","['aerosol inhalation treatment with IFN-κ and TFF2, every 48\xa0h for three consecutive dosages, in addition to standard treatment (experimental group), or standard treatment alone (control group', 'IFN-κ plus TFF2']","['median hospitalization stays', 'Safety and efficacy', 'safety evaluations', 'safety and efficacy', 'severe adverse effects (SAE', 'median time in cough relief']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",33.0,0.0403552,"No treatment-associated severe adverse effects (SAE) were observed in the group treated with aerosol inhalation of IFN-κ plus TFF2, and no significant differences in the safety evaluations were observed between experimental and control groups.","[{'ForeName': 'Weihui', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Huiliang', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Zongguo', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shan', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Corklin', 'Initials': 'C', 'LastName': 'Steinhart', 'Affiliation': 'Director of Research Development & Clinical Director of NW Florida, CAN Community Health 1825 Hurlburt Rd., Suite 14 Ft Walton Beach, FL 32547, United States.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 201508, PR China.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100478']
2331,32838673,Systolic Blood Pressure Reduction and Acute Kidney Injury in Intracerebral Hemorrhage.,"BACKGROUND AND PURPOSE


We determined the rates and predictors of acute kidney injury (AKI) and renal adverse events (AEs), and effects of AKI and renal AEs on death or disability in patients with intracerebral hemorrhage.
METHODS


We analyzed data from a multicenter trial which randomized 1000 intracerebral hemorrhage patients with initial systolic blood pressure ≥180 mm Hg to intensive (goal 110-139 mm Hg) over standard (goal 140-179 mm Hg) systolic blood pressure reduction within 4.5 hours of symptom onset. AKI was identified by serial assessment of daily serum creatinine for 3 days post randomization.
RESULTS


AKI and renal AEs were observed in 149 patients (14.9%) and 65 patients (6.5%) among 1000 patients, respectively. In multivariate analysis, the higher baseline serum creatinine (≥110 μmol/L) was associated with AKI (odds ratio 2.4 [95% CI, 1.2-4.5]) and renal AEs (odds ratio 3.1 [95% CI, 1.2-8.1]). Higher area under the curve for intravenous nicardipine dose was associated with AKI (odds ratio 1.003 [95% CI, 1.001-1.005]) and renal AEs (odds ratio 1.003 [95% CI, 1.001-1.006]). There was a higher risk to death (relative risk 2.6 [95% CI, 1.6-4.2]) and death or disability (relative risk 1.5 [95% CI, 1.3-1.8]) at 90 days in patients with AKI but not in those with renal AEs.
CONCLUSIONS


Intracerebral hemorrhage patients with higher baseline serum creatinine and those receiving higher doses of nicardipine were at higher risk for AKI and renal AEs. Occurrence of AKI was associated higher rates of death or disability at 3 months.
REGISTRATION


URL: https://clinicaltrials.gov. Unique identifier: NCT01176565.",2020,"There was a higher risk to death (relative risk 2.6 [95% CI, 1.6-4.2]) and death or disability (relative risk 1.5 [95% CI, 1.3-1.8]) at 90 days in patients with AKI but not in those with renal AEs.
","['patients with intracerebral hemorrhage', 'Intracerebral Hemorrhage', '1000 intracerebral hemorrhage patients with initial systolic blood pressure ≥180 mm', '110-139 mm Hg) over standard (goal 140-179 mm']",['nicardipine'],"['higher baseline serum creatinine', 'death or disability', 'Hg) systolic blood pressure reduction', 'Systolic Blood Pressure Reduction and Acute Kidney Injury', 'renal AEs', 'risk to death', 'AKI and renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4517609', 'cui_str': '179'}]","[{'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1000.0,0.543091,"There was a higher risk to death (relative risk 2.6 [95% CI, 1.6-4.2]) and death or disability (relative risk 1.5 [95% CI, 1.3-1.8]) at 90 days in patients with AKI but not in those with renal AEs.
","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, and Department of Neurology, University of Missouri-Columbia. (A.I.Q., W.H., I.L.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Zeenat Qureshi Stroke Institute, and Department of Neurology, University of Missouri-Columbia. (A.I.Q., W.H., I.L.).'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Zeenat Qureshi Stroke Institute, and Department of Neurology, University of Missouri-Columbia. (A.I.Q., W.H., I.L.).'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'The Neurology Department of Johns Hopkins University, Baltimore, MD (D.F.H.).'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan (C.Y.H.).'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Malhotra', 'Affiliation': 'Department of Nephrology, University of Missouri-Columbia. (K.M.).'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Department of Neurology, Klinikum Frankfurt Höchst, Germany (T.S.).'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Division of Neurosciences Critical Care, The Johns Hopkins University School of Medicine, Baltimore, MD (J.I.S.).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T.).'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan.'}]",Stroke,['10.1161/STROKEAHA.120.030272']
2332,32838676,Whole Health Action Management: A Randomized Controlled Trial of a Peer-Led Health Promotion Intervention.,"OBJECTIVE


Adults with serious mental illness have high rates of general medical comorbidity and encounter challenges in dealing with multiple health conditions. Chronic illness self-management programs may help them more effectively cope with comorbid illnesses, especially when instructors are certified peer specialists. This study assessed the longitudinal effectiveness of a peer-delivered health promotion program.
METHODS


Community mental health program clients in Georgia and Illinois with serious mental illness and health impairments were randomly assigned to receive either Whole Health Action Management (WHAM), a medical illness self-management program led by peer specialists, or care as usual, resulting in a sample of N=139 (WHAM N=68, control N=71). Assessments were conducted at study baseline and at 3 and 6 months. Generalized estimating equations were used to examine change over time in the primary outcome of patient activation and secondary outcomes of general health, hope, and employment.
RESULTS


Longitudinal analysis indicated that compared with control participants, WHAM participants demonstrated significantly greater improvement over time in patient activation for health care. Intervention participants also demonstrated greater improvement in their self-assessed general health, overall hopefulness, and paid employment. Reactions to the WHAM program were positive, with 97% reporting being very or somewhat satisfied, and almost two-thirds (63%) reporting that their health was better than before they joined the program.
CONCLUSIONS


The WHAM program improved patient activation, perceived general medical health, hopefulness, and likelihood of paid employment among people with serious mental illness and co-occurring medical conditions. Results suggest that peer-delivered health self-management education is effective and well received by participants.",2020,"The WHAM program improved patient activation, perceived general medical health, hopefulness, and likelihood of paid employment among people with serious mental illness and co-occurring medical conditions.","['Community mental health program clients in Georgia and Illinois with serious mental illness and health impairments', 'Adults with serious mental illness']","['Whole Health Action Management (WHAM), a medical illness self-management program led by peer specialists, or care as usual', 'Whole Health Action Management', 'Peer-Led Health Promotion Intervention', 'peer-delivered health promotion program']","['self-assessed general health, overall hopefulness, and paid employment', 'patient activation, perceived general medical health, hopefulness, and likelihood of paid employment', 'general health, hope, and employment']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0684336', 'cui_str': 'Impairment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",139.0,0.0492967,"The WHAM program improved patient activation, perceived general medical health, hopefulness, and likelihood of paid employment among people with serious mental illness and co-occurring medical conditions.","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Jonikas', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Jane K', 'Initials': 'JK', 'LastName': 'Burke-Miller', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hamilton', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Ike G', 'Initials': 'IG', 'LastName': 'Powell', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Sherry Jenkins', 'Initials': 'SJ', 'LastName': 'Tucker', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Jacqueline B', 'Initials': 'JB', 'LastName': 'Wolfgang', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Fricks', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Weidenaar', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}, {'ForeName': 'Destiny L', 'Initials': 'DL', 'LastName': 'Powers', 'Affiliation': ""Center on Mental Health Services Research and Policy, Department of Psychiatry, University of Illinois at Chicago, Chicago (Cook, Jonikas, Burke-Miller, Hamilton, Wolfgang); Appalachian Consulting Group, Cleveland, Georgia (Powell, Fricks); Georgia Mental Health Consumer Network, Atlanta (Tucker); Blue Cross Blue Shield of Illinois, Chicago (Weidenaar); Howard Brown Health, Chicago (Morris); Women's Treatment Center, Chicago (Powers).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000012']
2333,32838678,Technology-Assisted Teachers' Training to Promote Socioemotional Well-Being of Children in Public Schools in Rural Pakistan.,"BACKGROUND


The World Health Organization's (WHO) Eastern Mediterranean Regional Office (EMRO) developed a school mental health program (SMHP) to help reduce the burden of youth mental health problems. Designed in collaboration with international consultants, the SMHP draws on evidence-based interventions to train personnel to identify students in need, respond therapeutically, and engage families in seeking care.
METHODS


Teams from Pakistan, Egypt, Iran, and Jordan collaborated with the WHO EMRO and British and U.S. universities to form the School Health Implementation Network: Eastern Mediterranean Region (SHINE), a National Institute of Mental Health-funded global mental health hub. SHINE partners used a ""theory of change"" process to adapt the SMHP to be more readily adopted by school personnel and replicated with fidelity. The adapted SMHP more directly addresses teachers' priorities and uses technology to facilitate training.
RESULTS


A cluster-randomized implementation effectiveness trial enrolling 960 children ages 8-13 in 80 Pakistani schools will test the adapted SMHP against the original. Children who screen positive on first the teacher and subsequently the parent Strengths and Difficulties Questionnaires (SDQs) will be enrolled and tracked for 9 months. The primary trial outcome is reduction in parent-rated SDQ total difficulties scores. Secondary outcomes include children's well-being, academic performance, absenteeism, and perceived stigma; parent-teacher interaction; teachers' self-efficacy and subjective well-being; and school environment. Implementation outcomes include change in teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability.
NEXT STEPS


The trial began in October 2019, and the expected completion date is March 2021. Outcomes will inform dissemination of the SMHP in Pakistan and elsewhere.",2020,"Implementation outcomes include change in teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability.
","['960 children ages 8-13 in 80 Pakistani schools will test the adapted SMHP against the original', 'Teams from Pakistan, Egypt, Iran, and Jordan collaborated with the WHO EMRO and British and U.S. universities to form the School Health Implementation Network: Eastern Mediterranean Region (SHINE), a National Institute of Mental Health-funded global mental health hub', 'Children in Public Schools in Rural Pakistan']","[""Technology-Assisted Teachers' Training"", 'school mental health program (SMHP']","[""teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability"", 'reduction in parent-rated SDQ total difficulties scores', 'parent Strengths and Difficulties Questionnaires (SDQs', ""children's well-being, academic performance, absenteeism, and perceived stigma; parent-teacher interaction; teachers' self-efficacy and subjective well-being; and school environment""]","[{'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0282645', 'cui_str': 'Mediterranean Region'}, {'cui': 'C0027466', 'cui_str': 'National Institute of Mental Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",960.0,0.0687099,"Implementation outcomes include change in teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability.
","[{'ForeName': 'Syed Usman', 'Initials': 'SU', 'LastName': 'Hamdani', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Azza', 'Initials': 'A', 'LastName': 'Warraitch', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Suleman', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Naila', 'Initials': 'N', 'LastName': 'Muzzafar', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Fareed Aslam', 'Initials': 'FA', 'LastName': 'Minhas', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Asad Tameezuddin', 'Initials': 'AT', 'LastName': 'Nizami', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Pringle', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Hesham M', 'Initials': 'HM', 'LastName': 'Hamoda', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Wissow', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000005']
2334,32844454,Clinical relevance of positive patch test reactions to lanolin- a ROAT study.,"BACKGROUND


Lanolin is often included when patch testing for common contact allergens. The clinical relevance of a positive patch test reaction to lanolin markers though is still a subject for debate.
OBJECTIVES


To evaluate Amerchol L101 as a marker of lanolin allergy and investigate the clinical impact of lanolin containing moisturizers on healthy and damaged skin by Repeated Open Application Test (ROAT).
METHODS


Twelve test subjects and 14 controls were patch tested with Amerchol L 101 and additional lanolin markers. Subsequently, a blinded ROAT was performed on the arms of the study participants for 4 weeks. Each participant applied a lanolin-free cream base and two different lanolin-containing test creams twice daily on one arm with intact skin and one arm with irritant dermatitis, induced by sodium lauryl sulphate (SLS).
RESULTS


Eleven test subject (92%) had positive patch test reactions to Amerchol L 101 when retested and one test subject (8%) had a doubtful reaction. None of the study participants had any skin reactions for the ROAT on intact skin and all participants healed during the ROAT on damaged skin.
CONCLUSIONS


Lanolin-containing emollients do not cause or worsen existing dermatitis when performing ROAT in volunteers patch test positive to Amerchol L101. This article is protected by copyright. All rights reserved.",2020,"None of the study participants had any skin reactions for the ROAT on intact skin and all participants healed during the ROAT on damaged skin.
",['Twelve test subjects and 14 controls were patch tested with Amerchol L 101 and additional lanolin markers'],"['lanolin-free cream base and two different lanolin-containing test creams twice daily on one arm with intact skin and one arm with irritant dermatitis, induced by sodium lauryl sulphate (SLS']","['positive patch test reactions', 'skin reactions']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}, {'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2712179', 'cui_str': 'Intact skin'}, {'cui': 'C0162823', 'cui_str': 'Irritant contact dermatitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}]",,0.0319924,"None of the study participants had any skin reactions for the ROAT on intact skin and all participants healed during the ROAT on damaged skin.
","[{'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Uldahl', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Engfeldt', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svedman', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Skåne University Hospital, Lund University, Malmö, Sweden.'}]",Contact dermatitis,['10.1111/cod.13689']
2335,32844483,Comparisons of atropine versus cyclopentolate cycloplegia in myopic children.,"CLINICAL RELEVANCE


In clinical practice, 1% atropine and 1% cyclopentolate are used as cycloplegia agents to diagnose refractive error. The influence of 1% atropine on ocular biometry is obscure, and the impact of 1% cyclopentolate remains controversial.
BACKGROUND


This study aims to compare the effects of atropine versus cyclopentolate cycloplegia on ocular biometry in myopic children and to determine the sites of action for atropine.
METHODS


A total of 207 myopic children aged 6-12 years were included in the analysis. All participants underwent comprehensive eye examinations before and after cyclopentolate cycloplegia, after which they were randomly assigned into two groups, A and B, in a ratio of 1:1, to receive 1% or 0.01% atropine, respectively. The treatment was administered once every night for a week. Participants were re-examined one week later.
RESULTS


Cyclopentolate cycloplegia caused a decrease in choroidal thickness (-3 ± 9 μm, p = 0.001), elongation of axial length (9 ± 16 μm, p < 0.001), loss of lens power (-0.14 ± 0.37 dioptre, p < 0.001), and a hyperopic shift (0.14 ± 0.22 dioptre, p < 0.001) in both groups. However, ocular biometry showed different changes after one-week use of 1% or 0.01% atropine (all p < 0.001). In Group A, choroid thickening (24 ± 13 μm, p < 0.001) and reduced axial length (-30 ± 27 μm, p < 0.001) were observed after atropine cycloplegia, with greater changes in lens power (0.50 ± 0.37 dioptre, p < 0.001) and spherical equivalent (0.52 ± 0.23 dioptre, p < 0.001). Group B showed a slight increase in choroidal thickness following one-week use of 0.01% atropine (6 ± 9 μm, p < 0.001), but other biometric measures showed no significant changes.
CONCLUSION


Cyclopentolate and atropine cycloplegia have different effects on ocular biometry. Both 1% cyclopentolate cycloplegia and 0.01% atropine resulted in choroidal thickening, indicating that the choroid may be a site of action for atropine.",2020,"In Group A, choroid thickening (24 ± 13 μm, p < 0.001) and reduced axial length (-30 ± 27 μm, p < 0.001) were observed after atropine cycloplegia, with greater changes in lens power (0.50 ± 0.37 dioptre, p < 0.001) and spherical equivalent (0.52 ± 0.23 dioptre, p < 0.001).","['207 myopic children aged 6-12\u2009years', 'myopic children']","['cyclopentolate', 'Cyclopentolate', 'cyclopentolate cycloplegia', 'atropine']","['loss of lens power', 'lens power', 'ocular biometry', 'choroidal thickening', 'hyperopic shift', 'elongation of axial length', 'choroid thickening', 'choroidal thickness', 'reduced axial length']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010582', 'cui_str': 'Cyclopentolate'}, {'cui': 'C0235238', 'cui_str': 'Cycloplegia'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0008520', 'cui_str': 'Choroidal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",207.0,0.116724,"In Group A, choroid thickening (24 ± 13 μm, p < 0.001) and reduced axial length (-30 ± 27 μm, p < 0.001) were observed after atropine cycloplegia, with greater changes in lens power (0.50 ± 0.37 dioptre, p < 0.001) and spherical equivalent (0.52 ± 0.23 dioptre, p < 0.001).","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Shanghai Eye Disease Prevention and Treatment Centre, Shanghai Eye Hospital, Shanghai, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Shanghai Eye Disease Prevention and Treatment Centre, Shanghai Eye Hospital, Shanghai, China.'}, {'ForeName': 'Jiangnan', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Shanghai Eye Disease Prevention and Treatment Centre, Shanghai Eye Hospital, Shanghai, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Eye Disease Prevention and Treatment Centre, Shanghai Eye Hospital, Shanghai, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}]",Clinical & experimental optometry,['10.1111/cxo.13128']
2336,32844586,Intake of Fermented Dairy Products Induces a Less Pro-Inflammatory Postprandial Peripheral Blood Mononuclear Cell Gene Expression Response than Non-Fermented Dairy Products: A Randomized Controlled Cross-Over Trial.,"SCOPE


We aimed to investigate how intake of high-fat meals composed of different dairy products with a similar fat content affects postprandial peripheral blood mononuclear cell (PBMC) expression of inflammation related genes, as well as circulating inflammatory markers and metabolites.
METHODS AND RESULTS


Healthy subjects (n = 47) consumed four different high-fat meals composed of either butter, cheese, whipped cream or sour cream in a randomized controlled cross-over study. Fasting and postprandial PBMC gene expression, plasma metabolites and circulating inflammatory markers were measured. Using a linear mixed model, we found that expression of genes related to lymphocyte activation, cytokine signaling, chemokine signaling, and cell adhesion was differentially altered between the four meals. In general, intake of the fermented products cheese and sour cream reduced, while intake of the non-fermented products butter and whipped cream increased, expression of these genes. Plasma amino acid concentrations increased after intake of cheese compared to the other meals, and the amino acid changes correlated with several of the differentially altered genes.
CONCLUSION


Intake of fermented dairy products, especially cheese, induces a less inflammatory postprandial PBMC gene expression response than non-fermented dairy products. These findings may partly explain inconsistent findings in studies on health effects of dairy products. This article is protected by copyright. All rights reserved.",2020,"In general, intake of the fermented products cheese and sour cream reduced, while intake of the non-fermented products butter and whipped cream increased, expression of these genes.",['Healthy subjects (n = 47'],"['consumed four different high-fat meals composed of either butter, cheese, whipped cream or sour cream', 'Fermented Dairy Products']","['inflammatory postprandial PBMC gene expression response', 'Plasma amino acid concentrations', 'Fasting and postprandial PBMC gene expression, plasma metabolites and circulating inflammatory markers', 'lymphocyte activation, cytokine signaling, chemokine signaling, and cell adhesion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0452750', 'cui_str': 'Whipping cream'}, {'cui': 'C0452749', 'cui_str': 'Soured cream'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024262', 'cui_str': 'Blast Transformation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}]",47.0,0.0281853,"In general, intake of the fermented products cheese and sour cream reduced, while intake of the non-fermented products butter and whipped cream increased, expression of these genes.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rundblad', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Blindern, Oslo, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Blindern, Oslo, Norway.'}, {'ForeName': 'Linn Kl', 'Initials': 'LK', 'LastName': 'Øyri', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Blindern, Oslo, Norway.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Hansson', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Ingvild H', 'Initials': 'IH', 'LastName': 'Ivan', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Blindern, Oslo, Norway.'}, {'ForeName': 'Gyrd O', 'Initials': 'GO', 'LastName': 'Gjevestad', 'Affiliation': 'TINE SA, Marketing Department, Oslo, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Thoresen', 'Affiliation': 'Oslo Center for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Blindern, Oslo, Norway.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000319']
2337,32844597,"Can Playfulness be Stimulated? A Randomised Placebo-Controlled Online Playfulness Intervention Study on Effects on Trait Playfulness, Well-Being, and Depression.","BACKGROUND


While there are numerous applications of play-based interventions, there is little research on playfulness-based interventions. We applied interventions that aim at stimulating playfulness and test effects on happiness and depressive symptoms.
METHOD


In a randomised placebo-controlled online intervention, N = 533 participants were assigned to one of three 1-week playfulness conditions (i.e. three playful things, using playfulness in a new way, and counting playfulness) or a placebo condition. Participants reported on global playfulness, facets of playfulness, well-being, and depression at pretest, posttest, and at follow-ups after 2, 4, and 12 weeks.
RESULTS


All interventions increased expressions in all facets of playfulness, had short-term effects on well-being, and ameliorated depression.
CONCLUSION


Overall, findings suggest that playfulness can be stimulated by short self-administered interventions.",2020,"All interventions increased expressions in all facets of playfulness, had short-term effects on well-being, and ameliorated depression.
",[' N\xa0=\xa0533 participants'],"['placebo-controlled online intervention', 'Placebo', 'placebo condition']","['global playfulness, facets of playfulness, well-being, and depression', 'happiness and depressive symptoms', 'Trait Playfulness, Well-Being, and Depression']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",533.0,0.129305,"All interventions increased expressions in all facets of playfulness, had short-term effects on well-being, and ameliorated depression.
","[{'ForeName': 'René T', 'Initials': 'RT', 'LastName': 'Proyer', 'Affiliation': 'Martin-Luther-University Halle-Wittenberg, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Gander', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Brauer', 'Affiliation': 'Martin-Luther-University Halle-Wittenberg, Germany.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Chick', 'Affiliation': 'The Pennsylvania State University, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12220']
2338,32844599,"A double-blind, randomized, placebo-controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan.","OBJECTIVE


This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration.
METHODS


This randomized, double-blind, placebo-controlled, two-arm, parallel-group, prospective study enrolled 118 patients across 11 study sites in Taiwan. Subjects were randomized to imidafenacin or placebo in a 2:1 ratio and entered the 12-week treatment period. At the subsequent visits, efficacy outcome measures and safety assessments were collected for analysis. The primary efficacy outcome was the change in the mean number of micturitions per day. Secondary endpoints included mean changes from baseline in urgency episodes and urge incontinence episodes per day and mean volume voided per micturition. Safety outcomes were also collected and compared between groups.
RESULTS


A total of 78 and 40 patients were allocated to the imidafenacin and placebo groups, respectively. Among them, 100 patients (imidafenacin, 65 and placebo, 35) completed the trial. Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (-1.29 ± 2.23 vs -0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (-0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12. Adverse events were reported in 35 subjects (44.9%) and 16 (40%) in the imidafenacin and placebo groups, including constipation (n = 3, 4), dry mouth (n = 11, 2), and urinary tract infection (n = 7, 4), respectively. One patient in the imidafenacin group had mild dysuria.
CONCLUSION


Imidafenacin demonstrated efficacy and safety in the treatment of OAB in Taiwanese patients.",2020,"Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (-1.29 ± 2.23 vs -0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (-0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12.","['A total of 78 and 40 patients', 'Taiwanese patients', '100 patients (imidafenacin, 65 and placebo, 35) completed the trial', 'patients with overactive bladder in Taiwan', 'Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration', '118 patients across 11 study sites in Taiwan']","['Imidafenacin', 'placebo, imidafenacin', 'imidafenacin or placebo', 'imidafenacin', 'placebo', 'imidafenacin and placebo']","['mean number of micturitions per day', 'efficacy and safety', 'Safety outcomes', 'mean changes from baseline in urgency episodes and urge incontinence episodes per day and mean volume voided per micturition', 'Adverse events', 'mean number of urge incontinence episodes', 'urinary tract infection', 'mild dysuria', 'number of micturitions per day', 'constipation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1876226', 'cui_str': 'imidafenacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1876226', 'cui_str': 'imidafenacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",118.0,0.44184,"Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (-1.29 ± 2.23 vs -0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (-0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12.","[{'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Chih-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital and Department of Urology, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Ming', 'Initials': 'PM', 'LastName': 'Chow', 'Affiliation': 'Department of Urology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Shun', 'Initials': 'CS', 'LastName': 'Lien', 'Affiliation': 'Department of Urology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Ke-Hung', 'Initials': 'KH', 'LastName': 'Tsui', 'Affiliation': 'Department of Urology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Chieh-Lung', 'Initials': 'CL', 'LastName': 'Chou', 'Affiliation': 'Department of Urology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hsiang-Ying', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Meng', 'Affiliation': 'Division of Urology, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hann-Chorng', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, and Tzu Chi University, Hualien, Taiwan.'}]",Lower urinary tract symptoms,['10.1111/luts.12341']
2339,32844606,The influence of Intrapulmonary percussive ventilation on gastroesophageal reflux in infants under the age of one year.,"BACKGROUND


Intrapulmonarypercussiveventilation (IPV) is an airway clearance technique used at any age to facilitate the removal of secretions from the respiratory tract. The effect of IPV on gastroesophageal reflux(GER) is not well documented.This studyaimed to determine the influence of IPV on GER in infants.
METHODS


During a 24-hour multichannel intraluminal impedance-pH monitoring (MII-pH),infants in the intervention group received a20 minutessession of IPV in upright position, 2 hours postprandial. The control group received no intervention andwas placed in the same position for 20 minutes, 2 hours postprandial. The number of reflux episodes (REs) during IPV was compared to the number of REsin the control group during the 20 minutes period.
RESULTS


Fifty infants were included in each group;21 infants in the IPV group and 14 infants in the control group were diagnosed with abnormal MII-pH (p = 0.142). During IPV,thenumber of REswas significantly lower than in the control group (p< 0.001). Also in the subgroups with abnormal or normal MII-pH, a significantly lower number of REs during IPVwas found (p = 0.011, p = 0.011 respectively).
CONCLUSION


IPV decreases the number of REs in infants independent of the results of MII-pH. This article is protected by copyright. All rights reserved.",2020,"During IPV,thenumber of REswas significantly lower than in the control group (p< 0.001).","['infants under the age of one year', 'infants']","['Intrapulmonarypercussiveventilation (IPV', 'Intrapulmonary percussive ventilation', 'IPV']","['gastroesophageal reflux', 'number of REs during IPVwas', 'gastroesophageal reflux(GER', 'abnormal MII-pH', 'number of REs', 'number of reflux episodes (REs']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0442121', 'cui_str': 'Intrapulmonary'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}]",50.0,0.0341609,"During IPV,thenumber of REswas significantly lower than in the control group (p< 0.001).","[{'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Lievens', 'Affiliation': 'Rehabilitation Research, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Vandenplas', 'Affiliation': 'KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Vanlaethem', 'Affiliation': 'Physiotherapy Department, UZ Brussel, Brussels, Belgium.'}, {'ForeName': 'Filip Van', 'Initials': 'FV', 'LastName': 'Ginderdeuren', 'Affiliation': 'Rehabilitation Research, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}]",Pediatric pulmonology,['10.1002/ppul.25045']
2340,32844672,Impact of a Course of Add-on Supervised Yoga on Cortical Inhibition in Major Depressive Disorder: A Randomized Controlled Trial.,,2020,,['Major Depressive Disorder'],['Supervised Yoga'],[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.213314,,"[{'ForeName': 'Praerna H', 'Initials': 'PH', 'LastName': 'Bhargav', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Preethi V', 'Initials': 'PV', 'LastName': 'Reddy', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Ramajayam', 'Initials': 'R', 'LastName': 'Govindaraj', 'Affiliation': 'Department of Neurophysiology, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Kankan', 'Initials': 'K', 'LastName': 'Gulati', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Ravindran', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gayathri', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Sneha J', 'Initials': 'SJ', 'LastName': 'Karmani', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Kaviraja', 'Initials': 'K', 'LastName': 'Udupa', 'Affiliation': 'Department of Neurophysiology, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Mariamma', 'Initials': 'M', 'LastName': 'Philip', 'Affiliation': 'Department of Biostatistics, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Monojit', 'Initials': 'M', 'LastName': 'Debnath', 'Affiliation': 'Department of Human Genetics, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Department of Neuroimaging and Interventional Radiology, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Sathyaprabha', 'Affiliation': 'Department of Neurophysiology, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Bangalore N', 'Initials': 'BN', 'LastName': 'Gangadhar', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Kesavan', 'Initials': 'K', 'LastName': 'Muralidharan', 'Affiliation': 'Department of Psychiatry, 29148National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720953247']
2341,32844674,Virtual Scribe Services Decrease Documentation Burden Without Affecting Patient Satisfaction: A Randomized Controlled Trial.,"BACKGROUND


Virtual scribe services (VSS) are a contemporary take on the in-person scribes utilized as a means to reduce administrative burden on physicians and enhance the physician-patient interaction. The purpose of this study was to determine whether VSS use could decrease the time an orthopaedic foot and ankle surgeon spends on documentation without diminishing the patient experience as compared with traditional postencounter dictation (TD).
METHODS


Fifty patients presenting for first-time visits with a single orthopaedic foot and ankle surgeon were prospectively enrolled and randomized to VSS or TD prior to the physician-patient encounter. Time spent with the patient in the exam room and time spent documenting away from the patient were recorded. A postencounter survey assessed patient satisfaction, perception of physician empathy, understanding of the plan, and perception of the amount of time spent with the physician.
RESULTS


Of 50 patients enrolled, 25 were randomized to VSS. Time spent documenting away from the patient differed significantly between VSS and TD (1.2 ± 0.7 minutes for VSS vs 5.8 ± 1.7 minutes for TD,  P  < .001) as did time elapsed between the end of the visit and the start of dictation (0 ± 0 for VSS vs 118.2 ± 72.7 minutes for TD,  P  < .001). There was a trend toward more time spent with the patient in the VSS group than in the TD group (14.2 ± 5.9 minutes for VSS vs 11.4 ± 5.1 minutes for TD,  P  = .069). There were no differences between groups in survey responses regarding satisfaction, empathy, understanding, or perception of sufficient time spent with the physician ( P  > .05 for each).
CONCLUSIONS


VSS use in an orthopaedic foot and ankle practice significantly decreased documentation time and allowed for completion of documentation during patient visits without differences in quality metrics as compared to TD. Orthopaedic surgeons can consider VSS a HIPAA-compliant documentation option with time savings and no measurable difference in patient satisfaction.
LEVELS OF EVIDENCE


Level II: Randomized controlled trial.",2020,"Orthopaedic surgeons can consider VSS a HIPAA-compliant documentation option with time savings and no measurable difference in patient satisfaction.
","['50 patients enrolled, 25 were randomized to VSS', 'Fifty patients presenting for first-time visits with a single orthopaedic foot and ankle surgeon', 'Patient Satisfaction']","['VSS', 'VSS or TD', 'traditional postencounter dictation (TD']","['satisfaction, empathy, understanding, or perception of sufficient time spent with the physician', 'patient satisfaction, perception of physician empathy, understanding of the plan, and perception of the amount of time spent with the physician', 'documentation time', 'Time spent', 'time spent']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",50.0,0.0832799,"Orthopaedic surgeons can consider VSS a HIPAA-compliant documentation option with time savings and no measurable difference in patient satisfaction.
","[{'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Benko', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Idarraga', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bohl', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Kamran S', 'Initials': 'KS', 'LastName': 'Hamid', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}]",Foot & ankle specialist,['10.1177/1938640020950544']
2342,32835416,Intravenous immunoglobulin for presumed viral myocarditis in children and adults.,"BACKGROUND


This is an update of a previous review. Case reports and case series have described dramatic responses to intravenous immunoglobulin (IVIG) in people with presumed viral myocarditis, and its administration has become commonplace.
OBJECTIVES


The primary objective of this review was to compare event-free (death, requirement for a cardiac transplant, or placement of a left ventricular assist device) or overall (death) survival of adults and children with presumed viral myocarditis treated with IVIG versus those who did not receive IVIG. A secondary objective was to determine if a group of patients with presumed viral myocarditis could be identified (on the basis of age, duration of symptoms, acuity of onset of symptoms, cardiac function at presentation, virological results, or the presence or absence of histological evidence of acute myocarditis on cardiac biopsy in patients in whom a biopsy was performed) who would be the most likely to benefit from IVIG.
SEARCH METHODS


We searched CENTRAL, MEDLINE, Embase, DARE, CINAHL, Web of Science Core Collection, and LILACS in July 2019, and two trial registries in November 2019. We contacted authors of trials and checked reference lists of relevant papers. We applied no language restrictions.
SELECTION CRITERIA


We included studies if (1) participants had a clinical diagnosis of acute myocarditis with a left ventricular ejection fraction (LVEF) ≤ 0.45, left ventricular end-diastolic diameter (LVEDD) > 2 standard deviations (SDs) above the norm, or a left ventricular shortening fraction (LVSF) > 2 SDs below the mean, with duration of cardiac symptoms < 6 months; (2) participants had no evidence of non-infectious or bacterial cardiac disease; and (3) participants were randomly assigned to receive at least 1 g/kg of IVIG versus no IVIG or placebo. We excluded studies if (1) participants had received immunosuppression before outcome assessment; or (2) onset of myocarditis was reported to have occurred < 6 months postpartum.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened the search results and extracted data. We assessed risk of bias with the Cochrane 'Risk of bias' tool. We conducted meta-analysis for two outcomes (overall survival and improvement in LVEF) with two adult trials. Other meta-analyses were not possible because only three relevant trials were included, and researchers analysed markedly different populations and used different outcome measures.
MAIN RESULTS


In this update we added two trials to the two previously included trials. A quasi-randomised trial was previously included due to a paucity of evidence from randomised trials; however, with the addition of two new randomised trials, it was removed from this update. For two adult trials, the overall risk of bias was unclear with very low-certainty evidence for all outcomes. The first trial studied 62 adults with recent-onset dilated cardiomyopathy randomly assigned to receive IVIG or an equivalent volume of 0.1% albumin in a blinded fashion. The effect on event-free survival between groups was uncertain (risk ratio (RR) of any event 1.76, 95% confidence interval (CI) 0.48 to 6.40). The second trial studied 41 adults with acute myocarditis randomised to either high-dose IVIG (1 to 2 g/kg over two days) or no treatment. The IVIG group reported greater survival time after 60 days (no raw data, P < 0.01), but the evidence is uncertain. We pooled the reported number of deaths in both trials, with no evidence of a difference between groups (RR 0.91, 95% CI 0.23 to 3.62, I 2  = 31%, very low-certainty evidence). The evidence on the effect of IVIG treatment on LVEF (pooled mean difference (MD) -0.01, 95% CI -0.06 to 0.05) after 12 months and an unknown time frame is uncertain. The results for functional capacity, assessed by peak oxygen consumption at 12 months, were uncertain (MD -0.80, 95% CI -4.57 to 2.97). The results for infusion-related side effects were also uncertain due to a very large CI (RR 20.29, 95% CI 1.25 to 329.93). Lastly, there was uncertain evidence addressing failure to attain complete recovery (RR 0.46, 95% CI 0.19 to 1.14).  Evidence for improvement in LVEDD, left ventricular shortening fraction, and hospitalisation status in adults was not reported.  In the single included paediatric trial, the overall risk of bias was low with very low-certainty evidence for all outcomes. The trial included 86 children in Egypt presenting with acute myocarditis. Children were randomly assigned to 1 g/kg IVIG daily for two consecutive days or placebo followed by echocardiography one and six months post randomisation for recording of LVEDD and LVSF. The evidence for overall survival after six months was uncertain (risk of death RR 0.48, 95% CI 0.20 to 1.15). The evidence was also uncertain for improvement in LVEDD and LVSF after six months (LVEDD MD -4.00, 95% CI -9.52 to 1.52; LVSF no raw data).  Evidence for improvement in LVEF, functional capacity, side effects, complete recovery, and hospitalisation status in children was not reported.  AUTHORS' CONCLUSIONS: Evidence from two trials of very low certainty and with unclear risk of bias provides contradictory evidence on the use of IVIG in the treatment of adults with presumed viral myocarditis. One trial reported that use of IVIG results in longer survival time after 60 days, whilst the other trial found that IVIG does not provide an appreciable benefit. The evidence of a difference in event-free or overall survival, LVEDD, or LVSF is of very low certainty in a single paediatric trial with a low risk of bias. Until higher-quality studies with low risk of bias and larger sample sizes have demonstrated benefit in a particular group of patients, the evidence for treatment with IVIG for presumed viral myocarditis is uncertain. Further studies of the pathophysiology of myocarditis would lead to improved diagnostic criteria, which would facilitate future research.",2020,"The effect on event-free survival between groups was uncertain (risk ratio (RR) of any event 1.76, 95% confidence interval (CI) 0.48 to 6.40).","['1) participants had a clinical diagnosis of acute myocarditis with a left ventricular ejection fraction (LVEF) ≤ 0.45, left ventricular end-diastolic diameter (LVEDD) > 2 standard deviations (SDs) above the norm, or a left ventricular shortening fraction (LVSF', '41 adults with acute myocarditis randomised to either', '62 adults with recent-onset dilated cardiomyopathy randomly assigned to receive', 'adults and children with presumed viral myocarditis treated with IVIG versus those who did not receive IVIG', 'adults with presumed viral myocarditis', 'children and adults', ' (2) participants had no evidence of non-infectious or bacterial cardiac disease; and (3) participants', 'patients with presumed viral myocarditis could be identified (on the basis of age, duration of symptoms, acuity of onset of symptoms, cardiac function at presentation, virological results, or the presence or absence of histological evidence of acute myocarditis on cardiac biopsy in patients in whom a biopsy was performed) who would be the most likely to benefit from IVIG', '86 children in Egypt presenting with acute myocarditis']","['Intravenous immunoglobulin', 'IVIG versus no IVIG or placebo', 'IVIG or an equivalent volume of 0.1% albumin', 'intravenous immunoglobulin (IVIG', 'high-dose IVIG', 'placebo followed by echocardiography one and six months post randomisation for recording of LVEDD and LVSF']","['event-free or overall survival,\xa0LVEDD, or LVSF', 'survival time', 'peak oxygen consumption', 'longer survival time', 'event-free\xa0(death, requirement for a cardiac transplant, or placement of a left ventricular assist device) or overall (death) survival', 'LVEF, functional capacity, side effects, complete recovery, and hospitalisation status', 'LVEDD and LVSF', 'LVEDD, left ventricular shortening fraction, and hospitalisation status', 'overall survival']","[{'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0155686', 'cui_str': 'Acute myocarditis'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007193', 'cui_str': 'Dilated cardiomyopathy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0276138', 'cui_str': 'Viral myocarditis'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0189784', 'cui_str': 'Biopsy of heart'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",62.0,0.639081,"The effect on event-free survival between groups was uncertain (risk ratio (RR) of any event 1.76, 95% confidence interval (CI) 0.48 to 6.40).","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartling', 'Affiliation': 'Department of Pediatrics and the Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Vandermeer', 'Affiliation': 'Department of Pediatrics and the Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Sebastianski', 'Affiliation': 'Pediatrics (AB SPOR Knowledge Translation Unit), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': 'Manitoba Institute of Child Health, Winnipeg, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004370.pub4']
2343,32835443,Unilateral versus bilateral sacral neuromodulation test in the treatment of refractory idiopathic overactive bladder: A randomized controlled pilot trial.,"AIM


To compare treatment success rate in terms of improvement of bladder overactivity between unilateral and bilateral sacral neuromodulation testing.
METHODS


A multicentric, parallel, randomized, open pilot trial (October 2012-September 2017) was conducted. Participants presented primary overactive bladder resistant to first-line treatments. Patients were excluded in case of secondary bladder, pelvic, or neurological condition. Patients were randomized between bilateral testing (n = 28) or unilateral testing (n = 27), to determine the best functional response before final implantation. The primary outcome was the rate of patients presenting at least 50% of clinical improvement at 1 month on urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes. Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life were also assessed.
RESULTS


Fifty-five patients have been included. The rate of patients presenting at least one significant clinical improvement at month 1 was 62% in the bilateral group versus 84% in the unilateral group (P = .0891), RR = 0.74 (0.51; 1.07). There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411). More complications were reported in the bilateral group than in the unilateral group (9 [47%] vs 4 [16%], respectively; P = .0239).
CONCLUSION


Systematic bilateral sacral neuromodulation testing before final implantation did not appear to increase success rate compared with unilateral stimulation in the treatment of overactive bladder.",2020,"There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411).","['Participants presented primary overactive bladder resistant to first-line treatments', 'Patients were excluded in case of secondary bladder, pelvic, or neurological condition', 'Fifty-five patients have been included', 'refractory idiopathic overactive bladder']","['bilateral testing (n\u2009=\u200928) or unilateral testing', 'Unilateral versus bilateral sacral neuromodulation test']","['rate of patients presenting at least one significant clinical improvement', 'number of urge incontinence episodes', 'success rate', 'number of urinary urgency episodes', 'urinary frequency', 'Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life', 'urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes', 'More complications', 'rate of patients presenting at least 50% of clinical improvement']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.134808,"There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411).","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Department of Urology and Andrology, CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Alonso', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Le Normand', 'Affiliation': 'Department of Urology and Andrology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Faix', 'Affiliation': 'Department of Urology, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kabani', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Castelli', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gamé', 'Affiliation': 'Department of Urology, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Jean-Nicolas', 'Initials': 'JN', 'LastName': 'Cornu', 'Affiliation': 'Department of Urology, University Hospital of Rouen, Rouen, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Bey', 'Affiliation': 'Department of Urology and Andrology, CHU Nîmes, Univ Montpellier, Nîmes, France.'}]",Neurourology and urodynamics,['10.1002/nau.24476']
2344,32835465,Impact of primary care intensive management on medication adherence and adjustments.,"OBJECTIVES


The Veterans Health Administration implemented a pilot program for primary care intensive management (PIM) for patients at high risk for hospitalization. We examined the impact of the program on medication adherence and adjustments for patients with chronic conditions.
STUDY DESIGN


A randomized quality improvement trial was conducted in 5 sites in which high-risk patients were randomized into PIM or usual primary care; outcomes were measured in the 12 months before and after randomization. Interdisciplinary PIM teams assessed patients for unmet needs and offered services including pharmaceutical care and care coordination.
METHODS


Outcomes included adherence, measured by proportion of days covered, and several measures of medication adjustments for diabetes, depression, hyperlipidemia, and hypertension medications. Differences-in-differences methods were used to estimate changes in outcomes between PIM and usual care groups.
RESULTS


There were 1527 patients in the medication adherence cohort and 1719 in the medication adjustments cohort. Mean adherence was mostly similar between groups but 16% higher among PIM patients for dipeptidyl-peptidase-4 (DPP-4) inhibitors (for diabetes) after randomization (0.12 vs -0.04; P = .02). The mean number of hyperlipidemia drugs filled was higher among PIM patients (1.1 vs 1.0; P = .006). The mean number of discontinued depression medications was higher and the mean number of dose changes for hypertension medications was lower for PIM patients, although these comparisons did not reach statistical significance.
CONCLUSIONS


Medication adherence improved for DPP-4 inhibitors, and more hyperlipidemia drugs were prescribed for PIM patients. Overall impacts of PIM were modest.",2020,"The mean number of discontinued depression medications was higher and the mean number of dose changes for hypertension medications was lower for PIM patients, although these comparisons did not reach statistical significance.
","['5 sites in which high-risk patients', 'patients with chronic conditions', 'patients at high risk for hospitalization', '1527 patients in the medication adherence cohort and 1719 in the medication adjustments cohort']",['pilot program for primary care intensive management (PIM'],"['hypertension medications', 'mean number of discontinued depression medications', 'mean number of hyperlipidemia drugs filled', 'Mean adherence', 'adherence, measured by proportion of days covered, and several measures of medication adjustments for diabetes, depression, hyperlipidemia, and hypertension medications']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",,0.0469029,"The mean number of discontinued depression medications was higher and the mean number of dose changes for hypertension medications was lower for PIM patients, although these comparisons did not reach statistical significance.
","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'VA Health Economics Resource Center, VA Palo Alto Healthcare System, 795 Willow Rd, 152-MPD, Menlo Park, CA 94025. Email: jean.yoon@va.gov.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': ''}]",The American journal of managed care,['10.37765/ajmc.2020.44073']
2345,32835513,"The urinary 6-sulfatoxymelatonin level after three different work schedules with 2, 4 and 7 consecutive night shifts among Danish police officers.","Night shift work suppresses excretion of melatonin, but little is known about the needed time for recovery. We aimed to compare levels of 6-sulfatoxy melatonin after three different night shift schedules, including recovery days. In a quasi-experimental, within-subject crossover study, 73 male police officers in Denmark collected morning urine after the last recovery day in three different work schedules with two, four, and seven consecutive night shifts followed by a corresponding number of days for recovery. We found no significant differences for 6-sulphatoxymelatonin concentrations in morning urine between the three different work schedules indicating similar recovery of melatonin suppression in the studied work schedules.",2020,We found no significant differences for 6-sulphatoxymelatonin concentrations in morning urine between the three different work schedules indicating similar recovery of melatonin suppression in the studied work schedules.,['73 male police officers in Denmark collected morning urine'],[],"['urinary 6-sulfatoxymelatonin level', '6-sulphatoxymelatonin concentrations', '6-sulfatoxy melatonin']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086825', 'cui_str': 'Policeman'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",[],"[{'cui': 'C0049713', 'cui_str': '6-sulfatoxymelatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]",73.0,0.0201131,We found no significant differences for 6-sulphatoxymelatonin concentrations in morning urine between the three different work schedules indicating similar recovery of melatonin suppression in the studied work schedules.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Aarrebo Jensen', 'Affiliation': 'Department of Psychosocial work environment, National Research Centre for the Working Environment , Copenhagen, Denmark.'}, {'ForeName': 'Julie Boye', 'Initials': 'JB', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Psychosocial work environment, National Research Centre for the Working Environment , Copenhagen, Denmark.'}, {'ForeName': 'Jindong Ding', 'Initials': 'JD', 'LastName': 'Petersen', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark , Odense, Denmark.'}, {'ForeName': 'Åse Marie', 'Initials': 'ÅM', 'LastName': 'Hansen', 'Affiliation': 'Department of Psychosocial work environment, National Research Centre for the Working Environment , Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Psychosocial work environment, National Research Centre for the Working Environment , Copenhagen, Denmark.'}, {'ForeName': 'Anne Helene', 'Initials': 'AH', 'LastName': 'Garde', 'Affiliation': 'Department of Psychosocial work environment, National Research Centre for the Working Environment , Copenhagen, Denmark.'}]",Chronobiology international,['10.1080/07420528.2020.1807560']
2346,32835560,A vitamin E blended highly cross-linked polyethylene acetabular cup results in less wear: 6-year results of a randomized controlled trial in 199 patients.,"Background and purpose - Survivorship of total hip arthroplasty (THA) with the ultra-high molecular weight polyethylene (UHMWPE) monoblock cup has been limited due to periprosthetic osteolysis and aseptic loosening, secondary to wear of the UHMWPE. In response, a vitamin E blended highly cross-linked polyethylene (HXLPE) cup was developed. This study set out to compare the wear and clinical 6-year outcomes of vitamin E blended HXLPE with UHMWPE in an isoelastic monoblock cup in patients with hip osteoarthritis who underwent uncemented THA. The 2-year results have been reported previously.Patients and methods - For this randomized controlled trial 199 patients were included. 102 patients received the vitamin E blended HXLPE uncemented acetabular cup and 97 patients the uncemented UHMWPE monoblock cup. Clinical and radiographic parameters were obtained preoperatively, directly postoperatively, and at 3, 12, 24, and 72 months. Wear rates were compared using the femoral head penetration (FHP) rate.Results - 173 patients (87%) completed the 6-year follow-up. The mean NRS scores for rest pain, load pain, and patient satisfaction were 0.3 (SD 1), 0.6 (SD 1), and 8.6 (SD 1) respectively. The mean Harris Hip Score was 93 (SD 12). The FHP rate was lower in the vitamin E blended HXLPE cup (0.028 mm/year) compared with the UHMWPE cup (0.035 mm/year) (p = 0.002). No adverse reactions associated with the clinical application of vitamin E blended HXLPE were observed. 15 complications occurred, equally distributed between the two cups. The 6-year survival to revision rate was 98% for both cups. There was no aseptic loosening.Interpretation - This study shows the superior performance of the HXLPE blended with vitamin E acetabular cup with clinical and radiographic results similar to the UHMWPE acetabular cup.",2020,The FHP rate was lower in the vitamin E blended HXLPE cup (0.028 mm/year) compared with the UHMWPE cup (0.035 mm/year) (p = 0.002).,"['199 patients were included', 'and 97 patients the uncemented UHMWPE monoblock cup', '173 patients (87%) completed the 6-year follow-up', '199 patients', '102 patients received the', 'patients with hip osteoarthritis who underwent uncemented THA']","['vitamin E blended HXLPE uncemented acetabular cup', 'vitamin E blended highly cross-linked polyethylene acetabular cup', 'HXLPE blended with vitamin E acetabular cup', 'vitamin E blended HXLPE with UHMWPE', 'total hip arthroplasty (THA) with the ultra-high molecular weight polyethylene (UHMWPE', 'vitamin E blended highly cross-linked polyethylene (HXLPE']","['FHP rate', 'mean NRS scores for rest pain, load pain, and patient satisfaction', 'aseptic loosening', 'femoral head penetration (FHP) rate', '6-year survival to revision rate', 'mean Harris Hip Score', 'Wear rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0673477', 'cui_str': 'ultra-high molecular weight polyethylene'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0673477', 'cui_str': 'ultra-high molecular weight polyethylene'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}]",199.0,0.174816,The FHP rate was lower in the vitamin E blended HXLPE cup (0.028 mm/year) compared with the UHMWPE cup (0.035 mm/year) (p = 0.002).,"[{'ForeName': 'Julie R A', 'Initials': 'JRA', 'LastName': 'Massier', 'Affiliation': 'Clinical Orthopedic Research Center - mN, Zeist.'}, {'ForeName': 'Joost H J', 'Initials': 'JHJ', 'LastName': 'Van Erp', 'Affiliation': 'Clinical Orthopedic Research Center - mN, Zeist.'}, {'ForeName': 'Thom E', 'Initials': 'TE', 'LastName': 'Snijders', 'Affiliation': 'Clinical Orthopedic Research Center - mN, Zeist.'}, {'ForeName': 'Arthur DE', 'Initials': 'A', 'LastName': 'Gast', 'Affiliation': 'Clinical Orthopedic Research Center - mN, Zeist.'}]",Acta orthopaedica,['10.1080/17453674.2020.1807220']
2347,32835607,Effect of dispersed form on the bioavailability of β-carotene from daily intake in humans.,"In a randomized double-blind crossover study, a canned beverage was prepared using an emulsion dispersion formulation (EM) of β-carotene and a crystal dispersion formulation (CR) of β-carotene; the beverages were ingested by human subjects daily for 2 weeks to compare the β-carotene bioavailability. EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement. Bioaccessibility is the ratio of the solubilized fraction to the whole amount ingested. Bioaccessibility of β-carotene from EM-β-carotene was higher than that from CR-β-carotene in an  in vitro  digestion test. Contrarily, β-carotene from CR-β-carotene, consists of all- trans -β-carotene, was higher than that from EM-β-carotene, consists of a mixture of  cis  and all- trans -β-carotene, on the uptake by intestinal Caco-2 cells, suggesting that bioaccessibility was a critical factor in β-carotene bioavailability in this study. EM-β-carotene thus has potential as a food coloring agent with value added because it enhances β-carotene bioavailability.",2020,"EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement.",['humans'],"['EM-β-carotene', 'emulsion dispersion formulation (EM) of β-carotene and a crystal dispersion formulation (CR) of β-carotene']",['β-carotene bioavailability'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0342202,"EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement.","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Kotake-Nara', 'Affiliation': 'Food Research Institute, National Agriculture and Food Research Organization , Tsukuba, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Hase', 'Affiliation': 'Food Research Institute, National Agriculture and Food Research Organization , Tsukuba, Japan.'}]","Bioscience, biotechnology, and biochemistry",['10.1080/09168451.2020.1803728']
2348,32835687,Effects of exercise training on vascular markers of disease progression in patients with small abdominal aortic aneurysms.,"BACKGROUND


Currently, no medical therapy is effective in limiting progression of small abdominal aortic aneurysms (AAA; ≤ 5.5 cm). Previously, we have demonstrated safety and efficacy of exercise training in patients with AAA. However, the impact of exercise training on vascular markers of AAA progression, such as lipid accumulation product (lipid accumulation product) and matrix metalloproteinase 9 (MMP-9, linked to destruction of aortic matrix) is unknown. The aim of this study was to assess the impact of exercise training on AAA diameter, lipid accumulation product, MMP-9 and other risk markers of vascular disease.
METHODS AND DESIGN


In this randomized trial, complete data of 99 patients (male: n=87, female: n=9; exercise training (exercise) n=42, usual care n=54) were studied. Changes in AAA diameter, exercise capacity, lipid accumulation product (men = (waist circumference -65) × fasting triglycerides; women = (waist circumference-58) × triglycerides) and MMP-9 were performed.
RESULTS


The exercise group demonstrated a significant increase in maximal exercise time and estimated METs. lipid accumulation product decreased in exercise and increased in usual care (p<0.001 between groups); MMP-9 remained statistically unchanged in exercise, but increased significantly in usual care (p = 0.005; between groups p = 0.094). In both groups, there was a significant increase in transverse diameter, but no difference between groups; neither group assignment nor level of fitness correlated with AAA enlargement. No adverse clinical events occurred.
CONCLUSIONS


This is the first study to demonstrate that in AAA exercise beneficially modifies lipid accumulation product and MMP-9, both markers of vascular disease, without inducing aneurysmal growth beyond what is otherwise observed during usual care.",2020,"lipid accumulation product decreased in exercise and increased in usual care (p<0.001 between groups); MMP-9 remained statistically unchanged in exercise, but increased significantly in usual care (p = 0.005; between groups p = 0.094).","['patients with small abdominal aortic aneurysms', 'patients with AAA', '×\u202ffasting triglycerides; women\u202f=\u202f(waist circumference-58)\u202f×\u202ftriglycerides) and MMP-9 were performed', '99 patients (male: n=87, female: n=9']","['AAA exercise', 'exercise training (exercise', 'exercise training']","['vascular markers of disease progression', 'lipid accumulation', 'transverse diameter', 'AAA diameter, exercise capacity, lipid accumulation product', 'usual care', 'maximal exercise time and estimated METs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3658347', 'cui_str': 'Lipid Accumulation Product'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",99.0,0.0381692,"lipid accumulation product decreased in exercise and increased in usual care (p<0.001 between groups); MMP-9 remained statistically unchanged in exercise, but increased significantly in usual care (p = 0.005; between groups p = 0.094).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Niebauer', 'Affiliation': 'Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Dalman', 'Affiliation': 'Department of Surgery, Stanford University, Stanford, CA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiology, Department of Medicine, Stanford University, Stanford, CA. Electronic address: Drj993@aol.com.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.07.029']
2349,32835711,The influence of a liner on deep bulk-fill restorations: Randomized clinical trial.,"OBJECTIVE


The aim of this study was to evaluate the influence of a liner on the clinical performance of deep posterior restorations performed with bulk-fill composite.
METHODS


30 subjects received two restorations on deep preparations in posterior teeth, without pulpal exposure, after selective carious-tissue removal in one-stage. The internal walls reached the inner quarter of dentin, but with a radiographically detectable zone of firm dentin remaining. The pulpal protection using a layer of glass ionomer composite liner (Ionoseal, Voco) was applied in just one preparation. The adhesive system Futurabond U (Voco) was applied in all preparations, which were restored with the bulk-fill pure Ormocer nanohybrid composite (Admira Fusion Xtra - Voco), in up to 4 mm thick increments. All restorations were evaluated using the FDI criteria after 7 days, 6, 12 and 24 months postoperatively.
RESULTS


After 24-months, 25 patients attended the recall and 50 restorations were evaluated. The Fisher's statistical analysis (5%) showed no difference between the techniques for the esthetic, functional and biological properties. No postoperative sensitivity was reported for both groups.
CONCLUSION


The application of a liner did not influence the clinical performance of deep restorations with bulk-fill Ormocer composite.
CLINICAL RELEVANCE


The application of a liner with a GIC-based material has not a significant effect on the clinical performance of bulk-fill restorations and seems to be unnecessary for the material tested.",2020,"The application of a liner did not influence the clinical performance of deep restorations with bulk-fill Ormocer composite.
","['25 patients attended the recall and 50 restorations were evaluated', '30 subjects received two restorations on deep preparations in posterior teeth, without pulpal exposure, after selective carious-tissue removal in one-stage']",['bulk-fill composite'],['postoperative sensitivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",50.0,0.0409598,"The application of a liner did not influence the clinical performance of deep restorations with bulk-fill Ormocer composite.
","[{'ForeName': 'Rocha Gomes', 'Initials': 'RG', 'LastName': 'Carlos', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: Torres.carlos.rg.torres@unesp.br.'}, {'ForeName': 'Cintra Mailart', 'Initials': 'CM', 'LastName': 'Mariane', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: mariane_mailart@yahoo.com.br.'}, {'ForeName': 'Santos Rocha', 'Initials': 'SR', 'LastName': 'Rafael', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: rafaelrocha_ss@hotmail.com.'}, {'ForeName': 'Lenin Benitez Sellan', 'Initials': 'LBS', 'LastName': 'Pablo', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: drpablobens@gmail.com.'}, {'ForeName': 'Célia Mondragón Contreras', 'Initials': 'CMC', 'LastName': 'Sheila', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: sheilamondragon90@gmail.com.'}, {'ForeName': 'Di Nicoló', 'Initials': 'DN', 'LastName': 'Rebeca', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: rebeca.nicolo@unesp.br.'}, {'ForeName': 'Bühler Borges', 'Initials': 'BB', 'LastName': 'Alessandra', 'Affiliation': 'Sao Paulo State University - UNESP, Institute of Science and Technology, Department of Restorative Dentistry, São José Dos Campos, Avenida Engenheiro Francisco José Longo, 777, Jardim São Dimas, SP, 12245-000, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103454']
2350,32835752,DARTS Trial.,,2020,,[],[],[],[],[],[],,0.0897396,,"[{'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Brinkman', 'Affiliation': 'The Heart Hospital Baylor Plano, Division of Cardiac Surgery, 4716 Alliance Blvd, Pavilion 2, Suite 310, Plano, TX 75093. Electronic address: willibri@baylorhealth.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.06.046']
2351,32835919,Effect of sweet fennel seed extract capsule on knee pain in women with knee osteoarthritis.,"BACKGROUND AND OBJECTIVES


Knee osteoarthritis is one of the most common types of arthritis. The disease not only has a high disease burden but also reduces the quality of life of patients. The purpose of this research was to study the effect of Foeniculum vulgare Mill. (commonly known as Fennel) seed extract on knee pain in women patients with knee osteoarthritis.
METHODS


In this randomized, double-blind trial, a total of 66 patients were assigned randomly via the blocking method in two groups, fennel and placebo. All patients received four capsules daily of either powdered fennel extract (each capsule contained 200 mg dried fennel extract from 7 g of fennel seeds) or placebo twice a day for two weeks. The patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Visual Analog Scale (VAS) for pain intensity measurement before and after the study completion. Data were then analyzed via intention to treat method using the SPSS statistical software package.
RESULTS


Two weeks after the trial, a significant decrease was noted between the two groups in terms of pain, disability, total WOMAC score, and VAS variables. After comparing the pre- and post-intervention, the variables mentioned above revealed a significant decline in both groups. The stiffness variable indicated a significant reduction in the fennel group (between baseline and study completion) after two weeks, but this decline was not significant in the placebo group, and was not significant either between the two groups. At the end of the trial, the percentage change was higher in the fennel group than in the placebo group. Also, the effect size was greater in the fennel group especially in pain variable based on WOMAC and VAS than in the placebo group.
CONCLUSION


The results indicated that fennel may be an appropriate alternative for complementary treatment in patients with knee osteoarthritis. This study is the first clinical trial using oral fennel on knee pain in these patients, and the outcomes should be confirmed through additional studies.",2020,", a significant decrease was noted between the two groups in terms of pain, disability, total WOMAC score, and VAS variables.","['66 patients', 'women patients with knee osteoarthritis', 'women with knee osteoarthritis', 'patients with knee osteoarthritis']","['powdered fennel extract', 'sweet fennel seed extract capsule', 'Foeniculum vulgare Mill', 'fennel and placebo', 'placebo', 'oral fennel', 'Fennel) seed extract']","['Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Visual Analog Scale (VAS) for pain intensity measurement', 'knee pain', 'pain variable based on WOMAC and VAS', 'effect size', 'pain, disability, total WOMAC score, and VAS variables']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0015833', 'cui_str': 'Fennel extract'}, {'cui': 'C0453256', 'cui_str': 'Fennel seed preparation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0553175', 'cui_str': 'Foeniculum vulgare'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",66.0,0.250297,", a significant decrease was noted between the two groups in terms of pain, disability, total WOMAC score, and VAS variables.","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Alazadeh', 'Affiliation': 'Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran; Traditional and Complementary Medicine Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: marziehalazadeh@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azadbakht', 'Affiliation': 'Department of Pharmacognosy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Azadbakht110@gmail.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Niksolat', 'Affiliation': 'Orthopedic Research Center, Faculty of Medicine, Department of Internal Medicine, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Fniksolat@yahoo.com.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Asgarirad', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Dr_Asgarirad@yahoo.com.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Moosazadeh', 'Affiliation': 'Health Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Mmoosazadeh1351@gmail.com.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: amirhossein_pharma@yahoo.com.'}, {'ForeName': 'Seyde Sedighe', 'Initials': 'SS', 'LastName': 'Yousefi', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran; Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: s.yousefi@mazums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101219']
2352,32835925,Efficacy of donepezil for the attenuation of memory deficits associated with electroconvulsive therapy.,"We sought to confirm and extend the findings of studies that reported that acetylcholinesterase inhibitor drugs protect against electroconvulsive therapy (ECT)-induced cognitive impairment. We randomized 30 patients with depression (n=24) or schizophrenia (n=6) to receive either donepezil (10 mg/day; n=15) or placebo (n=15) during a fixed course of 6 thrice-weekly, modified, bifrontotemporal sine wave ECT, and for 30 days subsequently. We assessed memory using the Postgraduate Institute Memory Scale (PGI-MS) at baseline, and again at days 2, 7, and 30 after the ECT course. At baseline, memory functioning was comparable in the 2 groups. At 2 days post-ECT, memory functioning was impaired on almost all 10 subtests and on the total scale. At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself. There was no significant difference between groups in the primary outcome, improvement in PGI-MS scores between Days 2 and 30 post-ECT. On almost all subtests, also, there was no significant difference between groups. In summary, we found that donepezil (10 mg/day) did not improve memory outcomes after ECT.",2020,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.",['30 patients with depression (n=24) or schizophrenia (n=6) to receive either'],"['donepezil', 'placebo', 'electroconvulsive therapy']","['Postgraduate Institute Memory Scale (PGI-MS', 'memory outcomes', 'PGI-MS scores', 'memory functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.109804,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.","[{'ForeName': 'Lt Col Bikram', 'Initials': 'LCB', 'LastName': 'Dutta', 'Affiliation': 'Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India.'}, {'ForeName': 'Col Pradyot', 'Initials': 'CP', 'LastName': 'Sarkar', 'Affiliation': 'Ohio Hospital, New Town, Kolkata, India. Electronic address: colpsarkar@live.com.'}, {'ForeName': 'Chittaranjan', 'Initials': 'C', 'LastName': 'Andrade', 'Affiliation': 'Dean (Basic Sciences), Department of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore 560 029, India. Electronic address: andradec@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113397']
2353,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
2354,32836059,"No effect of feedback, level of processing or stimulus presentation protocol on perceptual learning when easy and difficult trials are interleaved.","The role of feedback during training is a topic of great theoretical importance in perceptual learning. Feedback can be provided externally by the environment or internally by the observer. In order to evaluate the effectiveness of learning with internal versus external feedback, we performed a large multi-level experiment, varying the type of training task (Motion or Form), the level of processing (Local or Global), the presence of feedback (With or Without) and finally the method of stimulus presentation (Adaptive staircase or Method of constant stimuli). 140 participants were randomly assigned to one of ten groups and undertook 3 days of training in one condition only. Detection thresholds were measured daily before and after training with a pre- and post-assessment. A 75% detection threshold was calculated and used to estimate that day's training levels (65% and 85% accuracy for difficult and easy trials respectively). The group trained with MOCS were presented with predefined randomly interleaved easy and difficult trials ranging from 50% to 95% stimulus intensity. Our findings indicate that improvement was generally robust across training-tasks, processing levels and feedback conditions. This suggests that internal reinforcement is as effective as external feedback in a discrete-noise-paradigm for local and global tasks when easy and difficult trials are interleaved.",2020,"Our findings indicate that improvement was generally robust across training-tasks, processing levels and feedback conditions.",['140 participants'],"['learning with internal versus external feedback', 'MOCS', 'training task (Motion or Form), the level of processing (Local or Global), the presence of feedback (With or Without) and finally the method of stimulus presentation (Adaptive staircase or Method of constant stimuli']",[],"[{'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",[],140.0,0.0215408,"Our findings indicate that improvement was generally robust across training-tasks, processing levels and feedback conditions.","[{'ForeName': 'Jordi M', 'Initials': 'JM', 'LastName': 'Asher', 'Affiliation': 'Department of Psychology, University of Essex, United Kingdom. Electronic address: jashera@essex.ac.uk.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Hibbard', 'Affiliation': 'Department of Psychology, University of Essex, United Kingdom.'}]",Vision research,['10.1016/j.visres.2020.07.011']
2355,32836063,"Efficacy of scalp nerve blocks using ropivacaïne 0,75% associated with intravenous dexamethasone for postoperative pain relief in craniotomies.","Pain after supratentorial craniotomy is common, 55 % to 80 % of patients experience moderate to severe pain in the first 48 h(1-7). The importance of intravenous dexamethasone as an adjuvant to local anaesthetics is increasingly applied(1-7), however its role in scalp nerve blocks with ropivacaine 0.75 % remains unexplored in post-operative analgesia. We analyzed 134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with ropivacaine 0.75 %. The general anaesthesia was standardized and included 8 mg of intravenous dexamethasone at the induction. The postoperative pain was assessed using the numerical rating scale with patients in the post anaesthesia care unit and subsequently every 8 h in the neurosurgery unit until the 48th hour. A NRS value above 3 led to the administration of a rescue analgesic according to the defined protocol until an efficient analgesia was obtained. Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group. More than 60 % of the patients from the scalp nerve blocks group had an efficient analgesia without any rescue analgesic. Peroperatively the scalp nerve blocks group showed a decrease in opioid consumption and a better hemodynamic stability. No anesthetic or chirurgical complications related to the use of scalp blocks were observed. Scalp nerve blocks associated with intravenous dexamethasone are found to be a straightforward and efficient analgesic approach during supratentorial craniotomies.",2020,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","['134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with', 'craniotomies']","['dexamethasone', 'ropivacaïne', 'ropivacaine']","['efficient analgesia without any rescue analgesic', 'postoperative pain relief', 'severe pain', 'hemodynamic stability', 'Postoperative pain', 'Pain', 'opioid consumption', 'postoperative pain']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",134.0,0.065171,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gaudray', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: eliott.gaudray@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""N' Guyen"", 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: cedric1.nguyen@intradef.gouv.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: edouard1.martin@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lyochon', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: arthur.lyochon@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dagain', 'Affiliation': 'Department of Neurosurgery, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: arnaud.dagain@intradef.gouv.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bordes', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: julien.bordes@intradef.gouv.fr.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Cordier', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: pierre-yves.cordier@intradef.gouv.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: guillaume.lacroix@intradef.gouv.fr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106125']
2356,32836103,Self-reported health status and the associated risk of mortality in heart failure: The DANISH trial.,"OBJECTIVE


To examine the gradual association between self-reported health status and mortality in patients with heart failure (HF) as current research has focused on poor health status and increased risk of mortality.
METHOD


This is a substudy of the DANISH (Defibrillator Implantation in Patients with Nonischemic Systolic HF) trial in which 1116 patients were randomized to receive or not receive an implantable cardioverter-defibrillator. Health status was assessed by a single question of the Short-Form 36. Patients were classified as having excellent/very good, good, fair (reference) or poor health status. We assessed the association between health status and mortality using multivariable Cox proportional hazard models.
RESULTS


Self-reported health status was completed by 943 (84%) patients at randomization with a median follow-up of 67 months and a health status distribution of; excellent/very good (n = 79, 8%), good (n = 369, 39%), fair (n = 409, 43%), and poor (n = 86, 9%). All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57). The gradual difference yielded a crude hazard ratio (HR) of 0.40, 95% CI 0.20-0.80 (adjusted HR 0.47 (95% CI 0.23-0.95) for excellent/ very good health status, HR 0.71, 95% CI 0.52-0.97 (adjusted HR 0.78 (95% CI 0.56-1.08) for good health status. Poor being worse than fair health status yielded a crude HR of 1.07, 95% CI 0.67-1.69.
CONCLUSION


Excellent/very good self-reported health status as assessed by a single question was associated with lower long-term mortality in patients with HF.",2020,"All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57).","['patients with heart failure (HF', 'patients with HF', 'heart failure', 'Patients with Nonischemic Systolic HF) trial in which 1116 patients', 'Patients were classified as having excellent/very good, good, fair (reference) or poor health status']","['implantable cardioverter-defibrillator', 'DANISH (Defibrillator Implantation']","['Self-reported health status', 'Health status', 'crude hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1116.0,0.0161855,"All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57).","[{'ForeName': 'Johan S', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: johan.skov.bundgaard.01@regionh.dk.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology and Clinical Research, Nordsjaellands Hospital, Hillerød, Denmark; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Rørth', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Melchior', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.; Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik M', 'Initials': 'UM', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110220']
2357,32836109,Sleep problems associated with long-term mortality in acute coronary syndrome: Effects of depression comorbidity and treatment.,"OBJECTIVES


The effects of sleep disturbance and its treatment on the prognosis of patients with acute coronary syndrome (ACS) are not well understood. This study investigated the impact of sleep disturbance on long-term all-cause mortality, according to depression comorbidity and treatment, in patients with ACS.
METHODS


A cross-sectional baseline study and a nested 24-week double-blind escitalopram-placebo controlled trial were carried out from May 2007 to March 2013; 5-12-year follow-up for all-cause mortality was conducted. A total of 1152 patients with ACS were stratified by baseline depression comorbidity and treatment allocation into four groups: no depression (N = 706), depression on escitalopram (N = 149), depression on placebo (N = 151), and depression on medical care as usual (CAU; N = 146). Sleep disturbance was evaluated by the Leeds Sleep Evaluation Questionnaire. During the 5-12-year follow-up, Kaplan-Meyer event rates for all-cause mortality were calculated; hazard ratios (HRs) using Cox regression models were estimated after adjustment for a range of covariates.
RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59). The associations between worse sleep states and long-term all-cause mortality were significant in patients without depression and in patients with depression who received CAU, but not in patients with depression who participated in the 24-week trial.
CONCLUSIONS


Routine evaluations of sleep disturbance in ACS and further treatment allocation may contribute to reducing long-term mortality associated with the disease.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier for the 24 week drug trial, NCT00419471.",2020,"RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59).","['May 2007 to March 2013; 5-12-year follow-up for all-cause mortality was conducted', 'acute coronary syndrome', '1152 patients with ACS were stratified by baseline depression comorbidity and treatment allocation into four groups: no depression (N\xa0=\xa0706), depression on escitalopram (N\xa0=\xa0149), depression on placebo (N\xa0=\xa0151), and depression on medical care as usual (CAU; N\xa0=\xa0146', 'patients with acute coronary syndrome (ACS', 'patients with ACS']","['CAU', 'escitalopram-placebo']","['Sleep disturbance', 'Leeds Sleep Evaluation Questionnaire']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1152.0,0.0763454,"RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59).","[{'ForeName': 'Ju-Wan', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK; South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'Hee-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Hee-Ju', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Sung-Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Il-Seon', 'Initials': 'IS', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Min-Chul', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Keun', 'Initials': 'YK', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Myung-Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jin-Sang', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea. Electronic address: jmkim@chonnam.ac.kr.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.08.004']
2358,32836188,Comparison of low and high inspiratory oxygen fraction added to lung-protective ventilation on postoperative pulmonary complications after abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative lung-protective ventilation strategy has been recommended to reduce postoperative pulmonary complications (PPCs). However, the role of inspiratory oxygen fraction (FiO 2 ) in this protection remains highly uncertain. We aimed to evaluate the effect of intraoperative low (30%) versus high (80%) FiO 2  in the context of lung-protective ventilation strategy on PPCs in patients undergoing abdominal surgery.
DESIGN


Prospective, two-arm, randomized controlled trial.
SETTING


Tertiary university hospital in China.
PATIENTS


A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study.
INTERVENTION


Patients were randomly assigned to receive either 30% or 80% FiO 2  during the intraoperative period. All patients received volume-controlled mechanical ventilation with lung-protective ventilation approach, which included a tidal volume of 8 ml kg -1  of predicted body weight, a positive end-expiratory pressure level of 6-8 cmH 2 O, and repeated recruitment maneuvers.
MEASUREMENTS


The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis. The severity grade of PPCs was measured as a key secondary outcome.
MAIN RESULTS


Two hundred and fifty-one patients completed the trial. PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025). The severity of PPCs within the first 7 days following surgery was attenuated significantly in the low (30%) FiO 2  group (p = 0.001).
CONCLUSIONS


Among patients undergoing abdominal surgery under general anesthesia, an intraoperative lung-protective ventilation strategy with 30% FiO 2  compared with 80% FiO 2  did not reduce the incidence of PPCs. And the use of 30% FiO 2  resulted in less severe pulmonary complications.",2020,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","['patients undergoing abdominal surgery', 'patients undergoing abdominal surgery under general anesthesia', 'Tertiary university hospital in China', 'Two hundred and fifty-one patients completed the trial', 'A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study', 'postoperative pulmonary complications after abdominal surgery']","['volume-controlled mechanical ventilation with lung-protective ventilation approach', 'low and high inspiratory oxygen fraction added to lung-protective ventilation']","['severe pulmonary complications', 'composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis', 'PPCs', 'severity of PPCs', 'severity grade of PPCs', 'incidence of PPCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.482006,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Yu-Lian', 'Initials': 'YL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Meng-Qiu', 'Initials': 'MQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China. Electronic address: yuhaishan117@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110009']
2359,32381738,Decisional autonomy undermines advisees' judgments of experts in medicine and in life.,"Over the past several decades, the United States medical system has increasingly prioritized patient autonomy. Physicians routinely encourage patients to come to their own decisions about their medical care rather than providing patients with clearer yet more paternalistic advice. Although political theorists, bioethicists, and philosophers generally see this as a positive trend, the present research examines the important question of how patients and advisees in general react to full decisional autonomy when making difficult decisions under uncertainty. Across six experiments ( N  = 3,867), we find that advisers who give advisees decisional autonomy rather than offering paternalistic advice are judged to be less competent and less helpful. As a result, advisees are less likely to return to and recommend these advisers and pay them lower wages. Importantly, we also demonstrate that advisers do not anticipate these effects. We document these results both inside and outside the medical domain, suggesting that the preference for paternalism is not unique to medicine but rather is a feature of situations in which there are adviser-advisee asymmetries in expertise. We find that the preference for paternalism holds when advice is solicited or unsolicited, when both paternalism and autonomy are accompanied by expert guidance, and it persists both before and after the outcomes of paternalistic advice are realized. Lastly, we see that the preference for paternalism only occurs when decision makers perceive their decision to be difficult. These results challenge the benefits of recently adopted practices in medical decision making that prioritize full decisional autonomy.",2020,"Across six experiments ( N  = 3,867), we find that advisers who give advisees decisional autonomy rather than offering paternalistic advice are judged to be less competent and less helpful.","[""Decisional autonomy undermines advisees' judgments of experts in medicine and in life""]",[],[],"[{'cui': 'C1822301', 'cui_str': 'Wound tissue undermining'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",[],[],,0.0196684,"Across six experiments ( N  = 3,867), we find that advisers who give advisees decisional autonomy rather than offering paternalistic advice are judged to be less competent and less helpful.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Kassirer', 'Affiliation': 'Kellogg School of Management, Northwestern University, Evanston, IL 60208; samantha.kassirer@kellogg.northwestern.edu.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Levine', 'Affiliation': 'Booth School of Business, University of Chicago, Chicago, IL, 60637.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Gaertig', 'Affiliation': 'Booth School of Business, University of Chicago, Chicago, IL, 60637.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1910572117']
2360,32479556,When good for business is not good enough: Effects of pro-diversity beliefs and instrumentality of diversity on intergroup attitudes.,"Instrumentality-based pro-diversity beliefs (i.e., beliefs that diverse groups outperform homogenous groups in terms of group functioning) have been shown to improve intergroup attitudes. However, such valuing of diversity due to its expected instrumentality holds the risk that outgroups may be devalued in situations when diversity ends up being detrimental to group functioning. Across four experiments, we studied the interplay between instrumentality-based pro-diversity beliefs, actual instrumentality of ethnic diversity, and outgroup attitudes. Our results do not reveal a robust interaction effect between instrumentality-based pro-diversity beliefs and actual instrumentality of diverse groups. Some evidence, however, supports the assumption that instrumentality-based pro-diversity beliefs yielded a weaker positive or even a negative effect on ethnic outgroup attitudes when ethnic diversity was perceived as non-instrumental (i.e., when diversity was perceived as having a negative impact on group functioning). Theoretical contributions, practical implications, and directions for future research are discussed.",2020,Our results do not reveal a robust interaction effect between instrumentality-based pro-diversity beliefs and actual instrumentality of diverse groups.,[],[],[],[],[],[],,0.0183642,Our results do not reveal a robust interaction effect between instrumentality-based pro-diversity beliefs and actual instrumentality of diverse groups.,"[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Kauff', 'Affiliation': 'Department of Psychology, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schmid', 'Affiliation': 'ESADE Business School, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Christ', 'Affiliation': 'Faculty of Psychology, FernUniversität in Hagen, Hagen, Germany.'}]",PloS one,['10.1371/journal.pone.0234179']
2361,32845399,Pain after permanent versus delayed absorbable monofilament suture for vaginal graft attachment during minimally invasive total hysterectomy and sacrocolpopexy.,"OBJECTIVES


The objective was to evaluate pain and dyspareunia in women undergoing minimally invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a light-weight polypropylene mesh 1 year after surgery.
METHODS


This is a planned secondary analysis of a randomized trial comparing permanent (Gore-Tex) versus absorbable suture (PDS) for vaginal attachment of a y-mesh (Upsylon™) during TLH + SCP in women with stage ≥II prolapse. Patient data were collected at baseline and 1 year after surgery. Our primary outcome was patient-reported pain or dyspareunia at 1 year.
RESULTS


Two hundred subjects (Gore-Tex n = 99, PDS n = 101) were randomized and underwent surgery. Overall, the mean age ± SD was 60 ± 10 years, and BMI was 27 ± 5 kg/m 2 . The majority were white (89%), menopausal (77%), and had stage III/IV (63%) prolapse. 93% completed a 1-year follow-up and are included in this analysis (Gor-Tex n = 95, PDS n = 90). The overall rate of participants who reported pain at 1 year was 20%. Of those who did not report any pain at baseline, 23% reported de novo dyspareunia, 4% reported de novo pain, and 3% reported both at 1 year. Of participants who reported pain or dyspareunia at baseline prior to surgery, 66% reported resolution of their symptoms at 1 year. There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year. On multiple logistic regression controlling for age, baseline dyspareunia, and baseline pain, baseline dyspareunia was associated with a nearly 4-fold increased odds of reporting any pain at 1 year (OR 3.8, 95%CI 1.7-8.9).
CONCLUSIONS


The majority of women report resolution of pain 1 year following TLH + SCP with a low rate of de novo pain.",2020,"There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year.","['women with stage ≥II prolapse', 'women undergoing minimally invasive total hysterectomy and', 'Two hundred subjects (Gore-Tex n\u2009=\u200999, PDS n\u2009=\u2009101']","['permanent (Gore-Tex) versus absorbable suture (PDS', 'TLH\u2009+\u2009SCP', 'sacrocolpopexy (TLH\u2009+\u2009SCP) with a light-weight polypropylene mesh', 'delayed absorbable monofilament suture']","['mesh/suture exposure', 'patient-reported pain or dyspareunia', 'de novo dyspareunia', 'baseline dyspareunia, and baseline pain, baseline dyspareunia', 'de novo pain', 'overall rate of participants who reported pain', 'pain and dyspareunia', 'Pain', 'pain or dyspareunia', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0018088', 'cui_str': 'Goretex'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0018088', 'cui_str': 'Goretex'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh'}, {'cui': 'C1961537', 'cui_str': 'Monofilament suture'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",200.0,0.715988,"There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year.","[{'ForeName': 'C Emi', 'Initials': 'CE', 'LastName': 'Bretschneider', 'Affiliation': 'Northwestern Feinstein School of Medicine, 250 E. Superior St. Suite 5-2370, Chicago, IL, 60611, USA. carol.bretschneider@nm.org.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kenton', 'Affiliation': 'Northwestern Feinstein School of Medicine, 250 E. Superior St. Suite 5-2370, Chicago, IL, 60611, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Geller', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wu', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Matthews', 'Affiliation': 'Department of Urology, Wake Forest Baptist Health, Winston Salem, NC, USA.'}]",International urogynecology journal,['10.1007/s00192-020-04471-6']
2362,32845407,A lactate-targeted resuscitation strategy may be associated with higher mortality in patients with septic shock and normal capillary refill time: a post hoc analysis of the ANDROMEDA-SHOCK study.,"BACKGROUND


Capillary refill time (CRT) may improve more rapidly than lactate in response to increments in systemic flow. Therefore, it can be assessed more frequently during septic shock (SS) resuscitation. Hyperlactatemia, in contrast, exhibits a slower recovery in SS survivors, probably explained by the delayed resolution of non-hypoperfusion-related sources. Thus, targeting lactate normalization may be associated with impaired outcomes. The ANDROMEDA-SHOCK trial compared CRT- versus lactate-targeted resuscitation in early SS. CRT-targeted resuscitation associated with lower mortality and organ dysfunction; mechanisms were not investigated. CRT was assessed every 30 min and lactate every 2 h during the 8-h intervention period, allowing a first comparison between groups at 2 h (T2). Our primary aim was to determine if SS patients evolving with normal CRT at T2 after randomization (T0) exhibited a higher mortality and organ dysfunction when allocated to the LT arm than when randomized to the CRT arm. Our secondary aim was to determine if those patients with normal CRT at T2 had received more therapeutic interventions when randomized to the LT arm. To address these issues, we performed a post hoc analysis of the ANDROMEDA-SHOCK dataset.
RESULTS


Patients randomized to the lactate arm at T0, evolving with normal CRT at T2 exhibited significantly higher mortality than patients with normal CRT at T2 initially allocated to CRT (40 vs 23%, p = 0.009). These results replicated at T8 and T24. LT arm received significantly more resuscitative interventions (fluid boluses: 1000[500-2000] vs. 500[0-1500], p = 0.004; norepinephrine test in previously hypertensive patients: 43 (35) vs. 19 (19), p = 0.001; and inodilators: 16 (13) vs. 3 (3), p = 0.003). A multivariate logistic regression of patients with normal CRT at T2, including APACHE-II, baseline lactate, cumulative fluids administered since emergency admission, source of infection, and randomization group) confirmed that allocation to LT group was a statistically significant determinant of 28-day mortality (OR 3.3; 95%CI[1.5-7.1]); p = 0.003).
CONCLUSIONS


Septic shock patients with normal CRT at baseline received more therapeutic interventions and presented more organ dysfunction when allocated to the lactate group. This could associate with worse outcomes.",2020,CRT-targeted resuscitation associated with lower mortality and organ dysfunction; mechanisms were not investigated.,"['patients with normal CRT at T2', 'patients with septic shock and normal capillary refill time', 'Septic shock patients with normal CRT']",['CRT'],"['CRT', '28-day mortality', 'organ dysfunction', 'mortality and organ dysfunction', 'mortality', 'resuscitative interventions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232357', 'cui_str': 'Normal capillary filling'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0425716', 'cui_str': 'Capillary filling'}]","[{'cui': 'C0425716', 'cui_str': 'Capillary filling'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.224819,CRT-targeted resuscitation associated with lower mortality and organ dysfunction; mechanisms were not investigated.,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Kattan', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, 362, Chile.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Hernández', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, 362, Chile.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Ospina-Tascón', 'Affiliation': 'Department of Intensive Care Medicine, Fundación Valle del Lili, Universidad ICESI, Carrera 98 # 18-49, Cali, Colombia.'}, {'ForeName': 'Emilio Daniel', 'Initials': 'ED', 'LastName': 'Valenzuela', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, 362, Chile.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, 362, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, 362, Chile. rcastro.med@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of intensive care,['10.1186/s13613-020-00732-1']
2363,32845446,Education vs Clinician Feedback on Antibiotic Prescriptions for Acute Respiratory Infections in Telemedicine: a Randomized Controlled Trial.,"BACKGROUND


Antibiotics prescribed for acute respiratory tract infections in the telemedicine setting are often unwarranted.
OBJECTIVE


We hypothesized that education plus individualized feedback, compared with education alone, would significantly reduce antibiotic prescription rates for upper respiratory infections, bronchitis, sinusitis, and pharyngitis in a telemedicine setting.
DESIGN


Two-arm, parallel-group randomized controlled trial conducted at a telemedicine practice from January 1, 2018, to November 30, 2018.
PARTICIPANTS


Clinicians employed at the practice on or after January 1, 2017 (n = 45).
INTERVENTIONS


The control group received education (treatment guideline presentation and online course) in April 2018. The intervention group received education plus individualized feedback via an online dashboard with monthly rates of personal and practice-wide antibiotic prescription rates starting May 2018.
MAIN MEASURES


Antibiotic prescription for any visit with at least one target condition: upper respiratory tract infection, bronchitis, sinusitis, and pharyngitis.
KEY RESULTS


Baseline antibiotic prescription rates in control and intervention groups across conditions were as follows: upper respiratory infection (URI): 626/3410 (18.4%), 413/2752 (15.0%), bronchitis: 689/1471 (46.8%), 742/1162 (64.0%), sinusitis: 5154/6131 (84.1%), 4250/4876 (87.2%), pharyngitis: 2308/2838 (81.3%), 1593/2126 (74.9%). Antibiotic prescriptions for all conditions decreased in the post-intervention period compared with those in the pre-intervention period, for both control and intervention groups. Reduction of antibiotic prescriptions for URI and bronchitis was greater for the group receiving education plus individualized feedback compared with that for the group receiving education alone (interaction term ratio 0.60, 95% CI 0.47 to 0.77 for URI; and interaction term ratio 0.42, 95% CI 0.32 to 0.55 for bronchitis), but not sinusitis and pharyngitis.
CONCLUSION


Education plus individualized feedback in a telemedicine practice significantly decreased antibiotic prescription rates for upper respiratory tract infections and bronchitis, compared with education alone. Future studies should focus on tailoring antibiotic stewardship programs based on underlying conditions, and the maintenance of early reductions in antibiotic prescription.",2020,"Reduction of antibiotic prescriptions for URI and bronchitis was greater for the group receiving education plus individualized feedback compared with that for the group receiving education alone (interaction term ratio 0.60, 95% CI 0.47 to 0.77 for URI; and interaction term ratio 0.42, 95% CI 0.32 to 0.55 for bronchitis), but not sinusitis and pharyngitis.
","['Acute Respiratory Infections in Telemedicine', 'Clinicians employed at the practice on or after January 1, 2017 (n = 45', 'from January 1, 2018, to November 30, 2018']","['telemedicine practice', 'education plus individualized feedback via an online dashboard with monthly rates of personal and practice-wide antibiotic prescription rates starting May 2018', 'Education vs Clinician Feedback', 'Antibiotic prescription']","['antibiotic prescription rates', 'upper respiratory infection (URI', 'bronchitis', 'Reduction of antibiotic prescriptions for URI and bronchitis']","[{'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.10151,"Reduction of antibiotic prescriptions for URI and bronchitis was greater for the group receiving education plus individualized feedback compared with that for the group receiving education alone (interaction term ratio 0.60, 95% CI 0.47 to 0.77 for URI; and interaction term ratio 0.42, 95% CI 0.32 to 0.55 for bronchitis), but not sinusitis and pharyngitis.
","[{'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Du Yan', 'Affiliation': 'Boston Medical Center, , Boston, MA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Dean', 'Affiliation': 'Doctor On Demand, Professional Corporation, , San Francisco, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Antibiotic Resistance Action Center, Department of Environmental and Occupational Health, George Washington Milken Institute of Public Health, , Washington, DC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Doctor On Demand, Professional Corporation, , San Francisco, CA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Tong', 'Affiliation': 'Doctor On Demand, Professional Corporation, , San Francisco, CA, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Antibiotic Resistance Action Center, Department of Environmental and Occupational Health, George Washington Milken Institute of Public Health, , Washington, DC, USA.'}, {'ForeName': 'Rana F', 'Initials': 'RF', 'LastName': 'Hamdy', 'Affiliation': 'Antibiotic Resistance Action Center, Department of Environmental and Occupational Health, George Washington Milken Institute of Public Health, , Washington, DC, USA. rhamdy@childrensnational.org.'}]",Journal of general internal medicine,['10.1007/s11606-020-06134-0']
2364,32845449,Artificial endocrine pancreas with a closed-loop system effectively suppresses the accelerated hyperglycemic status after reperfusion during aortic surgery.,"OBJECTIVES


To control intraoperative hyperglycemia in patients who underwent aortic surgery using STG-55 ®  artificial endocrine pancreas and clarify the effectiveness of this device.
METHODS


Blood glucose control using the STG-55 ®  was performed in 18 patients (15 men and 3 women; age, 66 ± 10 years) who required hypothermic circulatory arrest (STG-55 ®  group). Seventeen patients (10 men and 7 women; age, 71 ± 8 years) whose blood glucose was controlled using the conventional method were included in the control group. Glucose concentration was controlled with the aim of maintaining it at 150 mg/dl.
RESULTS


In both groups, the blood glucose concentrations did not significantly change during the interruption of systemic perfusion; however, a sharp increase was noted immediately after reperfusion. Although the hyperglycemic status persisted after reperfusion in the control group, it was effectively suppressed in the STG-55 ®  group (STG ®  vs. control group at 50 min after reperfusion: 180 ± 35 vs. 212 ± 47 mg/dl, p = 0.026) and blood glucose concentration reached the target value of 150 mg/dl at 100 min after reperfusion (STG ®  vs. control group: 153 ± 29 vs. 215 ± 43 mg/dl, p = 0.0008). The total administered insulin dose was 175 ± 81 U and 5 ± 3 U in the STG ®  and control groups, respectively (p < 0.0001).
CONCLUSIONS


To treat the accelerated hyperglycemic status in aortic surgery requiring circulatory arrest, strict glycemic control using an artificial endocrine pancreas might be beneficial.",2020,"In both groups, the blood glucose concentrations did not significantly change during the interruption of systemic perfusion; however, a sharp increase was noted immediately after reperfusion.","['18 patients (15 men and 3 women; age, 66\u2009±\u200910\xa0years) who required hypothermic circulatory arrest (STG-55 ®  group', 'patients who underwent aortic surgery using STG-55 ®  artificial endocrine pancreas', 'Seventeen patients (10 men and 7 women; age, 71\u2009±\u20098\xa0years) whose blood glucose was controlled using the conventional method were included in the control group']",['STG-55 ®'],"['Glucose concentration', 'blood glucose concentration', 'hyperglycemic status', 'accelerated hyperglycemic status', 'blood glucose concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0444720', 'cui_str': 'Circulatory arrest'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]",18.0,0.0213292,"In both groups, the blood glucose concentrations did not significantly change during the interruption of systemic perfusion; however, a sharp increase was noted immediately after reperfusion.","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Aizawa', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan. tcvai@jichi.ac.jp.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Muraoka', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Soki', 'Initials': 'S', 'LastName': 'Kurumisawa', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Akutsu', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sugaya', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Uesugi', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kawahito', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-020-01415-1']
2365,32845475,Effects of endobronchial coils for endoscopic lung volume reduction on sleep in COPD patients with advanced pulmonary emphysema.,"PURPOSE


Treatment of advanced pulmonary emphysema with endobronchial coils can improve clinical outcomes like quality of life (QOL). Yet, patients with chronic obstructive pulmonary disease (COPD) are also known to suffer from reduced sleep quality. The effect of coil therapy on sleep has not yet been investigated. The primary aim of this study was to investigate sleep efficiency before and after coil treatment. Secondly, we investigated the effects on nocturnal breathing pattern, QOL, and physical activity.
METHODS


Polysomnography (PSG) testing was performed before (T0), 6 month after (T3), and 12 months after (T4) treatment with endobronchial coils. Further examinations included QOL by St George's Respiratory Questionnaire (SGRQ) and COPD assessment test (CAT), and physical activity using an accelerometer for 1 week after each visit.
RESULTS


Of 21 patients, 14 completed the study: 6 women; mean age 58.0 ± 4.9 years; BMI 22.6 ± 4.6 kg/m 2 ; FEV 1  28.6 ± 7.1% predicted; residual volume (RV) 278.2 ± 49.4% predicted. Sleep efficiency did not vary between baseline and follow-up examinations (T0 69.0 ± 15.8%; T3 70.9 ± 16.0%; T4 66.8 ± 18.9%). Non-REM respiratory rate decreased compared to baseline (T0 19.4 ± 3.9/min; T3 17.8 ± 3.5/min; T4 17.1 ± 3.1/min (p = 0.041; p = 0.030) and QOL improved meeting the minimal clinically important difference (MCID) (SGRQ, T3 -12.8 units; T4 -7.1 units; CAT: T3 -5.6 units; T4 -3.4 units). No increase in physical activity was recorded (light activity T0 31.9 ± 9.9; T3 30.8 ± 16.9; T4 26.3 ± 10.6 h/week).
CONCLUSIONS


Treatment with endobronchial coils did not influence objectively measured sleep quality or physical activity, but reduced nocturnal breathing frequency and improved QOL in severe emphysema patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02399514, First Posted: March 26, 2015.",2020,"No increase in physical activity was recorded (light activity T0 31.9 ± 9.9; T3 30.8 ± 16.9; T4 26.3 ± 10.6 h/week).
","['patients with chronic obstructive pulmonary disease (COPD', ' 14 completed the study: 6 women; mean\xa0age 58.0 ± 4.9\xa0years; BMI 22.6 ± 4.6 kg/m 2 ; FEV 1  28.6 ± 7.1% predicted; residual volume (RV) 278.2 ± 49.4% predicted', '21 patients', 'severe emphysema patients', 'COPD patients with advanced pulmonary emphysema', 'advanced pulmonary emphysema with']","['coil therapy', 'endobronchial coils']","['sleep efficiency', 'Sleep efficiency', 'clinical outcomes like quality of life (QOL', 'nocturnal breathing pattern, QOL, and physical activity', 'sleep quality or physical activity', ""QOL by St George's Respiratory Questionnaire (SGRQ) and COPD assessment test (CAT), and physical activity"", 'physical activity', 'QOL', 'nocturnal breathing frequency and improved QOL', 'Non-REM respiratory rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034067', 'cui_str': 'Pulmonary emphysema'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",6.0,0.0660215,"No increase in physical activity was recorded (light activity T0 31.9 ± 9.9; T3 30.8 ± 16.9; T4 26.3 ± 10.6 h/week).
","[{'ForeName': 'Karl-Josef', 'Initials': 'KJ', 'LastName': 'Franke', 'Affiliation': 'Märkische Kliniken GmbH, Klinikum Lüdenscheid, Lüdenscheid, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Domanski', 'Affiliation': 'VAMED Klinik Hagen-Ambrock GmbH, Hagen, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Schröder', 'Affiliation': 'Kliniken Essen-Mitte, Essen, Germany. m.schroeder@kem-med.com.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nilius', 'Affiliation': 'Kliniken Essen-Mitte, Essen, Germany.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02176-0']
2366,32845553,Can self-monitoring mobile health apps reduce sedentary behavior? A randomized controlled trial.,"OBJECTIVE


To examine whether the self-monitoring interventions of a mobile health app reduce sedentary behavior in the short and long terms.
METHOD


We designed a double-blind randomized control trial. Participants were selected from among the staff of a medical institution and registrants of an online research firm. Forty-nine participants were randomly assigned to either a control group (n = 25) or an intervention group (n = 24). The control group was given only the latest information about sedentary behavior, and the intervention was provided real-time feedback for self-monitoring in addition to the information. These interventions provided for 5 weeks (to measure the short-term effect) and 13 weeks (to measure the long-term effect) via the smartphone app. Measurements were as follows: subjective total sedentary time (SST), objective total sedentary time (OST), mean sedentary bout duration (MSB), and the number of sedentary breaks (SB). Only SST was measured by self-report based on the standardized International Physical Activity Questionnaire and others were measured with the smartphone.
RESULTS


No significant results were observed in the short term. In the long term, while no significant results were also observed in objective sedentary behavior (OST, MSB, SB), the significant differences were observed in subjective sedentary behavior (SST, β int   - β ctrl  between baseline and 9/13 weeks; 1.73 and 1.50 h/d, respectively).
CONCLUSIONS


Real-time feedback for self-monitoring with smartphone did not significantly affect objective sedentary behavior. However, providing only information about sedentary behavior to users with smartphones may make misperception on the amount of their subjective sedentary behavior.",2020,"In the long term, while no significant results were also observed in objective sedentary behavior (OST, MSB, SB), the significant differences were observed in subjective sedentary behavior (SST, β int   - ","['Participants were selected from among the staff of a medical institution and registrants of an online research firm', 'Forty-nine participants']",[],"['objective sedentary behavior (OST, MSB, SB', 'subjective total sedentary time (SST), objective total sedentary time (OST), mean sedentary bout duration (MSB), and the number of sedentary breaks (SB', 'subjective sedentary behavior (SST, β int  \xa0', 'sedentary behavior', 'standardized International Physical Activity Questionnaire', 'objective sedentary behavior']","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205233', 'cui_str': 'Firm'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",49.0,0.0478229,"In the long term, while no significant results were also observed in objective sedentary behavior (OST, MSB, SB), the significant differences were observed in subjective sedentary behavior (SST, β int   - ","[{'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ebara', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Matsuda', 'Affiliation': 'The Ohara Memorial Institute for Science of Labour, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Matsukawa', 'Affiliation': 'Faculty of Information Science, Aichi Institute of Technology, Toyota, Japan.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Nagoya City University Graduate School of Economics, Nagoya, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishii', 'Affiliation': 'The Ohara Memorial Institute for Science of Labour, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kurihara', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Matsuki', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Naomichi', 'Initials': 'N', 'LastName': 'Tani', 'Affiliation': 'The Association for Preventive Medicine of Japan, Fukuoka, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kamijima', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",Journal of occupational health,['10.1002/1348-9585.12159']
2367,32845588,Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis.,"Background: Presence of nail psoriasis in patients with plaque psoriasis may be an indicator of greater disease severity. Previously, patients with nail psoriasis have had delayed skin clearance after treatment compared to patients without nail psoriasis. Objective: This post-hoc analysis evaluated the efficacy of ixekizumab in clearance of plaque psoriasis in patients with and without nail psoriasis. Methods: Data were integrated from two phase 3 clinical trials (UNCOVER-2 and UNCOVER-3; N=2570) to assess skin response over 12 weeks of treatment with subcutaneous placebo, etanercept, or ixekizumab in patients with and without nail psoriasis. Nail response was assessed using Nail Psoriasis Severity Index (NAPSI) and skin response was assessed as the percentage of patients achieving 75%, 90%, or 100% improvement in Psoriasis Area and Severity Index (PASI 75, PASI 90, PASI 100) or a score of 0 or 1 on the static Physician Global Assessment (sPGA 0 or 0,1). Results: From baseline to week 12, progressive improvement in psoriasis occurred with ixekizumab and etanercept treatment; however, significantly more patients with nail psoriasis than without mild PASI 75 at weeks 8 and 12 and sPGA (0,1) at week 12 with ixekizumab. Significantly more patients with severe nail psoriasis than mild achieved PASI 75 at weeks 8 and 12 with ixekizumab. Conclusion: Patients with and without nail psoriasis responded well to ixekizumab. The presence of nail psoriasis did not negatively affect skin clearance in patients treated with ixekizumab. ClinicalTrials.gov: NCT01597245, NCT01646177 J Drugs Dermatol. 2020;19(8):741-746. doi:10.36849/JDD.2020.5116.",2020,The presence of nail psoriasis did not negatively affect skin clearance in patients treated with ixekizumab.,"['patients with nail psoriasis', 'Conclusion: Patients with and without nail psoriasis', 'patients with plaque psoriasis', 'patients with and without nail psoriasis', 'Patients With Moderate-To-Severe Psoriasis']","['ixekizumab', 'subcutaneous placebo, etanercept, or ixekizumab']","['delayed skin clearance', 'severe nail psoriasis', 'Nail Psoriasis Severity Index (NAPSI) and skin response', 'nail psoriasis', 'skin clearance', 'progressive improvement in psoriasis', 'Skin Response to Ixekizumab', 'Psoriasis Area and Severity Index', 'skin response', 'Nail response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}]",,0.0678825,The presence of nail psoriasis did not negatively affect skin clearance in patients treated with ixekizumab.,"[{'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Rich', 'Affiliation': ''}, {'ForeName': 'Orin', 'Initials': 'O', 'LastName': 'Goldblum', 'Affiliation': ''}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Disch', 'Affiliation': ''}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ''}, {'ForeName': 'Boni', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5116']
2368,32845589,Halobetasol Propionate Lotion 0.01% for Moderate-to-Severe Plaque Psoriasis: Pooled Analysis in Male and Female Participants.,"Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups. Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2‑grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8. Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250.",2020,Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both).,"['male and female subgroups', 'male (n=253) and female (n=177) subgroups included', 'Male and Female Participants', 'Moderate-to-Severe Plaque Psoriasis', 'male and female participants with moderate-to-severe psoriasis']","['halobetasol propionate (HP) 0.01% lotion', 'HP or vehicle lotion', 'Halobetasol Propionate Lotion', 'HP lotion']","['rates of IGA-rated treatment success', ""treatment success (≥2‑grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA"", 'BSA', 'efficacy and safety', 'disease severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.268562,Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both).,"[{'ForeName': 'Fran E', 'Initials': 'FE', 'LastName': 'Cook-Bolden', 'Affiliation': ''}, {'ForeName': 'Adelaide A', 'Initials': 'AA', 'LastName': 'Hebert', 'Affiliation': ''}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Guenthner', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5250']
2369,32786197,Outcomes of the Neonatal Trial of High-Frequency Oscillation at 16 to 19 Years.,,2020,,[],[],[],[],[],[],,0.047818,,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': ""King's College London, London, United Kingdom.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bisquera', 'Affiliation': ""King's College London, London, United Kingdom.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lunt', 'Affiliation': 'Imperial College, London, United Kingdom.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': 'Dartmouth College, Hanover, NH.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""King's College London, London, United Kingdom anne.greenough@kcl.ac.uk.""}]",The New England journal of medicine,['10.1056/NEJMc2008677']
2370,32671977,Is it possible to predict the onset of nocturnal asymptomatic hypoglycemia in patients with type 1 diabetes receiving insulin degludec? Potential role of previous day and next morning glucose values.,"AIMS/INTRODUCTION


To determine whether the occurrence of nocturnal asymptomatic, serious, clinically important hypoglycemia (NSH) could be predicted based on glucose values on the previous day and the following morning of the day of onset.
MATERIALS AND METHODS


This study examined patients with type 1 diabetes who underwent continuous glucose monitoring assessments and received insulin degludec. NSH was defined as glucose level <54 mg/dL detected between 24.00 and 06.00 hours. The participants were evaluated to determine the following: (i) glucose level at bedtime (24.00 hours) on the previous day (BG); (ii) fasting glucose level (FG); and (iii) the range of post-breakfast glucose elevation. The patients were divided into those with NSH and those without, and compared using t-tests. Optimal cut-off values for relevant parameters for predicting NSH were determined using receiver operating characteristic analysis.
RESULTS


The study included a total of 31 patients with type 1 diabetes (mean glycated hemoglobin value 7.8 ± 0.7%). NSH occurred in eight patients (26%). BG and FG were significantly lower in those with NSH than in those without (P = 0.044, P < 0.001). The range of post-breakfast glucose elevation was significantly greater in those with NSH than in those without. The cut-off glucose values for predicting NSH were as follows: BG = 90 mg/dL (sensitivity 0.83/specificity 0.75/area under the curve 0.79, P = 0.017) and FG = 69 mg/dL (0.83/0.75/0.86, P = 0.003).
CONCLUSIONS


The results showed that in patients with type 1 diabetes receiving insulin degludec, BG <90 mg/dL and FG <69 mg/dL had an approximately 80% probability of predicting the occurrence of NSH.",2020,"BG and FG were significantly lower in those with NSH than in those without (P = 0.044, P < 0.001).","['patients with type\xa01 diabetes who underwent', 'patients with type\xa01 diabetes receiving insulin degludec', '31 patients with type\xa01 diabetes (mean glycated hemoglobin value 7.8\xa0±\xa00.7', 'patients with type\xa01 diabetes receiving insulin degludec, BG <90']","['dL', 'NSH', 'continuous glucose monitoring assessments and received insulin degludec', 'BG']","['NSH', 'range of post-breakfast glucose elevation', 'occurrence of NSH', 'BG and FG', 'nocturnal asymptomatic hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439087', 'cui_str': '<90'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C3544295', 'cui_str': 'Asymptomatic hypoglycaemia'}]",31.0,0.0238737,"BG and FG were significantly lower in those with NSH than in those without (P = 0.044, P < 0.001).","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Rimei', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13363']
2371,32690489,Intranasal versus intramuscular naloxone for opioid overdose.,"Review of:  Dietze P, Jauncey M, Salmon A. Effect of intranasal vs intramuscular naloxone on opioid overdose: a randomised clinical trial.  JAMA Network Open  2019;2:e1914977.",2020,"Review of:  Dietze P, Jauncey M, Salmon A. Effect of intranasal vs intramuscular naloxone on opioid overdose: a randomised clinical trial.  ",[],"['intranasal vs intramuscular naloxone', 'Intranasal versus intramuscular naloxone', 'JAMA Network Open']",['opioid overdose'],[],"[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",,0.0498725,"Review of:  Dietze P, Jauncey M, Salmon A. Effect of intranasal vs intramuscular naloxone on opioid overdose: a randomised clinical trial.  ",[],Drug and therapeutics bulletin,['10.1136/dtb.2020.000046']
2372,31578168,"Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study.","BACKGROUND


Transbronchial lung cryobiopsy (TBLC) is a novel technique for sampling lung tissue for interstitial lung disease diagnosis. The aim of this study was to establish the diagnostic accuracy of TBLC compared with surgical lung biopsy (SLB), in the context of increasing use of TBLC in clinical practice as a less invasive biopsy technique.
METHODS


COLDICE was a prospective, multicentre, diagnostic accuracy study investigating diagnostic agreement between TBLC and SLB, across nine Australian tertiary hospitals. Patients with interstitial lung disease aged between 18 and 80 years were eligible for inclusion if they required histopathological evaluation to aid diagnosis, after detailed baseline evaluation. After screening at a centralised multidisciplinary discussion (MDD), patients with interstitial lung disease referred for lung biopsy underwent sequential TBLC and SLB under one anaesthetic. Each tissue sample was assigned a number between 1 and 130, allocated in a computer-generated random sequence. Encoded biopsy samples were then analysed by masked pathologists. At subsequent MDD, de-identified cases were discussed twice with either TBLC or SLB along with clinical and radiological data, in random non-consecutive order. Co-primary endpoints were agreement of histopathological features in TBLC and SLB for patterns of definite or probable usual interstitial pneumonia, indeterminate for usual interstitial pneumonia, and alternative diagnosis; and for agreement of consensus clinical diagnosis using TBLC and SLB at MDD. Concordance and κ values were calculated for each primary endpoint. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12615000718549.
FINDINGS


Between March 15, 2016, and April 15, 2019, we enrolled 65 patients (31 [48%] men, 34 [52%] women; mean age 66·1 years [SD 9·3]; forced vital capacity 83·7% [SD 14·2]; diffusing capacity for carbon monoxide 63·4% [SD 12·8]). TBLC (7·1 mm, SD 1·9) and SLB (46·5 mm, 14·9) samples were each taken from two separate ipsilateral lobes. Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78). For TBLC with high or definite diagnostic confidence at MDD (39 [60%] of 65 cases), 37 (95%) were concordant with SLB diagnoses. In the 26 (40%) of 65 cases with low-confidence or unclassifiable TBLC diagnoses, SLB reclassified six (23%) to alternative high-confidence or definite MDD diagnoses. Mild-moderate airway bleeding occurred in 14 (22%) patients due to TBLC. The 90-day mortality was 2% (one of 65 patients), following acute exacerbation of idiopathic pulmonary fibrosis.
INTERPRETATION


High levels of agreement between TBLC and SLB for both histopathological interpretation and MDD diagnoses were shown. The TBLC MDD diagnoses made with high confidence were particularly reliable, showing excellent concordance with SLB MDD diagnoses. These data support the clinical utility of TBLC in interstitial lung disease diagnostic algorithms. Further studies investigating the safety profile of TBLC are needed.
FUNDING


University of Sydney, Hunter Medical Research Institute, Erbe Elektromedizin, Medtronic, Cook Medical, Rymed, Karl-Storz, Zeiss, and Olympus.",2020,"Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78).","['interstitial lung disease diagnosis (COLDICE', 'Between March 15, 2016, and April 15, 2019', 'Patients with interstitial lung disease aged between 18 and 80 years were eligible for inclusion if they required histopathological evaluation to aid diagnosis, after detailed baseline evaluation', 'enrolled 65 patients (31 [48%] men, 34 [52%] women', 'patients with interstitial lung disease referred for lung biopsy underwent sequential TBLC and SLB under one anaesthetic', 'nine Australian tertiary hospitals']","['TBLC or SLB', 'Transbronchial lung cryobiopsy (TBLC', 'transbronchial lung cryobiopsy', 'TBLC and SLB', 'surgical lung biopsy (SLB', 'TBLC']","['Concordance and κ values', 'histopathological features in TBLC and SLB for patterns of definite or probable usual interstitial pneumonia, indeterminate for usual interstitial pneumonia, and alternative diagnosis', 'Histopathological agreement between TBLC and SLB', 'Mild-moderate airway bleeding', '90-day mortality']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",65.0,0.0467771,"Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78).","[{'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Troy', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: ltroy@med.usyd.edu.au.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Grainge', 'Affiliation': 'John Hunter Hospital, New Lambton Heights, NSW, Australia; Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Hospital, Liverpool, NSW, Australia; Macquarie University Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Vallely', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Macquarie University Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Cooper', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Mahar', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Myers', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbour, MI, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Mulyadi', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Phillips', 'Affiliation': 'Macquarie University Hospital, Sydney, NSW, Australia; Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Jo', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Susanne E', 'Initials': 'SE', 'LastName': 'Webster', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Qi T', 'Initials': 'QT', 'LastName': 'Lin', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Rhodes', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Salamonsen', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Wrobel', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia; University of Notre Dame Australia, Fremantle, WA, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harris', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Artarmon, NSW, Australia.'}, {'ForeName': 'Garrick', 'Initials': 'G', 'LastName': 'Don', 'Affiliation': 'Royal North Shore Hospital, Artarmon, NSW, Australia.'}, {'ForeName': 'Peter J C', 'Initials': 'PJC', 'LastName': 'Wu', 'Affiliation': 'Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ng', 'Affiliation': 'Nepean Hospital, Kingswood, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Edmund M T', 'Initials': 'EMT', 'LastName': 'Lau', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30342-X']
2373,31645648,A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia.,"Recently, mRNA-expression signature enriched in LSCs was used to create a 17-gene leukemic stem cell (LSC17) score predictive of prognosis in adult AML. By fitting a Cox-LASSO regression model to the clinical outcome and gene-expression levels of LSC enriched genes in 163 pediatric participants of the AML02 multi-center clinical trial (NCT00136084), we developed a six-gene LSC score of prognostic value in pediatric AML (pLSC6). In the AML02 cohort, the 5-year event-free survival (EFS) of patients within low-pLSC6 group (n = 97) was 78.3 (95% CI = 70.5-86.9%) as compared with 34.5(95% CI = 24.7-48.2 %) in patients within high-pLSC6 group (n = 66 subjects), p < 0.00001. pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age. pLSC6 formula developed in the AML02 cohort was validated in the pediatric AML-TARGET project data (n = 205), confirming its prognostic value in both single-predictor and multiple-predictor Cox regression models. In both cohorts, pLSC6 predicted outcome of transplant patients, suggesting it as a useful criterion for transplant referrals. Our results suggest that pLSC6 score holds promise in redefining initial risk-stratification and identifying poor risk AML thereby providing guidance for developing novel treatment strategies.",2020,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","['risk pediatric acute myeloid leukemia', '163 pediatric participants']",['pLSC6'],"['EFS and overall survival (OS', '5-year event-free survival (EFS']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",163.0,0.0725067,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Leukemia,['10.1038/s41375-019-0604-8']
2374,31653513,Platelet function and activation markers in primary hypercholesterolemia treated with anti-PCSK9 monoclonal antibody: A 12-month follow-up.,"BACKGROUND AND AIMS


In the association between hypercholesterolemia (HC) and thrombotic risk platelet hyper-reactivity plays an important role. The inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) to reduce plasma LDL-cholesterol merges as effective therapeutic strategy to prevent cardiovascular (CV) events. Aim of this study was to verify whether a treatment up to 12 months with the monoclonal antibodies (mAbs) anti-PCSK9 influences platelet function in primary HC.
METHODS AND RESULTS


In patients affected by primary HC (n = 24), all on background of statin and 17 on acetyl salicylic acid (ASA), platelet function parameters were evaluated at baseline up to 12 months of treatment with the mAb anti-PCSK9 alirocumab or evolocumab. From baseline, the treatment with anti-PCSK9 mAbs: i) in ASA HC patients, significantly decreased platelet aggregation detected in platelet-rich plasma by light transmission aggregometry and in whole blood Platelet Function Analyzer-100 assay; ii) in all HC patients, significantly decreased platelet membrane expression of CD62P and plasma levels of the in vivo platelet activation markers soluble CD40 Ligand, Platelet Factor-4, and soluble P-Selectin. Furthermore, CD62P expression, and sP-Selectin, PF-4, sCD40L levels significantly correlated with serum PCSK9.
CONCLUSION


Besides markedly lowering LDL-c levels, our results suggest that HC patients benefit from anti-PCSK9 mAb treatment also for reducing platelet reactivity and increasing platelet sensitivity to the inhibitory effects of aspirin. These effects on platelets could play a role in the reduction of CV event incidence in patients treated with PCSK9 inhibitors.",2020,"Furthermore, CD62P expression, and sP-Selectin, PF-4, sCD40L levels significantly correlated with serum","['patients treated with PCSK9 inhibitors', 'primary HC', 'primary hypercholesterolemia treated with anti-PCSK9 monoclonal antibody']","['mAb anti-PCSK9 alirocumab or evolocumab', 'monoclonal antibodies (mAbs) anti-PCSK9', 'aspirin']","['Furthermore, CD62P expression, and sP-Selectin, PF-4, sCD40L levels', 'acetyl salicylic acid (ASA), platelet function parameters', 'platelet aggregation', 'platelet membrane expression of CD62P and plasma levels', 'platelet activation markers soluble CD40 Ligand, Platelet Factor-4, and soluble P-Selectin', 'Platelet function and activation markers', 'LDL-c levels', 'platelet reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4522007', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0342879', 'cui_str': 'Primary hypercholesterolemia'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0167627', 'cui_str': 'Lymphocyte antigen CD154'}, {'cui': 'C0032183', 'cui_str': 'Platelet factor 4'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0168842,"Furthermore, CD62P expression, and sP-Selectin, PF-4, sCD40L levels significantly correlated with serum","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Barale', 'Affiliation': 'Department of Clinical and Biological Sciences of Turin University, Orbassano, Turin, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Bonomo', 'Affiliation': 'Metabolic Disease and Diabetes Unit, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Frascaroli', 'Affiliation': 'Metabolic Disease and Diabetes Unit, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Morotti', 'Affiliation': 'Department of Clinical and Biological Sciences of Turin University, Orbassano, Turin, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Guerrasio', 'Affiliation': 'Department of Clinical and Biological Sciences of Turin University, Orbassano, Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cavalot', 'Affiliation': 'Metabolic Disease and Diabetes Unit, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Russo', 'Affiliation': 'Department of Clinical and Biological Sciences of Turin University, Orbassano, Turin, Italy. Electronic address: isabella.russo@unito.it.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.09.012']
2375,31862192,Impact of endotracheal tube twisting on the diagnostic accuracy of ultrasound for intubation confirmation.,"INTRODUCTION


Ultrasound is a readily-available technique used to identify accurate placement of an endotracheal tube (ETT) after an intubation attempt. There is limited research on using manipulation of the ETT to improve the diagnostic accuracy of ETT location confirmation. Our study sought to directly assess whether ETT twisting during the standard grayscale technique influenced the accuracy of intubation confirmation by ultrasound.
METHODS


The study was performed using two different fresh cadavers. During each trial, the cadavers were randomized to either tracheal or esophageal intubation. Three blinded, ultrasound fellowship-trained sonographers assessed the location of the ETT post-intubation alternating between using either a technique with no ETT movement or a technique with ETT twisting. In the latter technique, the sonographers manipulated the ETT in using a side-to-side, twisting motion while performing the ultrasound exam. The study measured the accuracy of ETT location identification, time to identification, and sonographer confidence.
RESULTS


540 assessments were performed with equal numbers of tracheal and esophageal intubations. The accuracy of ultrasound using the static technique was 97.8% (95% CI 95.2% to 99.0%) and the accuracy using the ETT twisting technique was 100% (95% CI 98.6% to 100%). The ETT twisting group showed a faster time to identification with a mean time to identification of 4.97 s (95% CI 4.36 to 5.57 s) compared to 6.87 s (95% CI 6.30 to 7.44 s) for the static ETT group. Operator confidence was also higher in the ETT twisting group at 4.84/5.0 (95% CI 4.79 to 4.90) compared to 4.71/5.0 (95% CI 4.63 to 4.78) in the static ETT group.
CONCLUSION


There was no statistically significant difference in the accuracy of ETT location identification between the two groups. However, utilizing the ETT twisting technique showed a statistically significant improvement in the time to identification and sonographer confidence.",2020,The ETT twisting group showed a faster time to identification with a mean time to identification of 4.97 s (95% CI 4.36 to 5.57 s) compared to 6.87 ,[],"['tracheal or esophageal intubation', 'ultrasound fellowship-trained sonographers assessed the location of the ETT post-intubation alternating between using either a technique with no ETT movement or a technique with ETT twisting', 'endotracheal tube twisting']","['Operator confidence', 'accuracy of ETT location identification', 'accuracy of ultrasound using the static technique', 'accuracy of ETT location identification, time to identification, and sonographer confidence', 'time to identification and sonographer confidence']",[],"[{'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0192301', 'cui_str': 'Insertion of catheter into esophagus, permanent tube type'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",540.0,0.0469435,The ETT twisting group showed a faster time to identification with a mean time to identification of 4.97 s (95% CI 4.36 to 5.57 s) compared to 6.87 ,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Emergency Medicine, Rush University Medical Center, Chicago, IL, United States. Electronic address: MichaelGottliebMD@Gmail.com.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Burns', 'Affiliation': 'Department of Emergency Medicine, Advocate Christ Medical Center, Chicago, IL, United States.'}, {'ForeName': 'Dallas', 'Initials': 'D', 'LastName': 'Holladay', 'Affiliation': 'Department of Emergency Medicine, Rush University Medical Center, Chicago, IL, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chottiner', 'Affiliation': 'Department of Emergency Medicine, Rush University Medical Center, Chicago, IL, United States.'}, {'ForeName': 'Shital', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Emergency Medicine, Rush University Medical Center, Chicago, IL, United States.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Gore', 'Affiliation': 'Department of Emergency Medicine, Rush University Medical Center, Chicago, IL, United States.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.10.032']
2376,31926812,A novel tDCS sham approach based on model-driven controlled shunting.,"BACKGROUND


Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique able to transiently modulate brain activity, is surging as one of the most promising therapeutic solutions in many neurological and psychiatric disorders. However, profound limitations exist in current placebo (sham) protocols that limit single- and double-blinding, especially in non-naïve subjects.
OBJECTIVE


To ensure better blinding and strengthen reliability of tDCS studies and trials, we tested a new optimization algorithm aimed at creating an ""active"" sham tDCS condition (ActiSham hereafter) capable of inducing the same scalp sensations perceived during real stimulation while preventing currents from reaching the cortex and cause changes in brain excitability.
METHODS


A novel model-based multielectrode technique - optimizing the location and currents of a set of small electrodes placed on the scalp - was used to control the relative amount of current delivered transcranially in real and placebo multichannel tDCS conditions. The presence, intensity and localization of scalp sensations during tDCS was evaluated by means of a specifically designed questionnaire administered to the participants. We compared blinding ratings by directly addressing subjects' ability to discriminate across conditions for both traditional (Bifocal-tDCS and Sham, using sponge electrodes) and our novel multifocal approach (both real Multifocal-tDCS and ActiSham). Changes in corticospinal excitability were monitored based on Motor Evoked Potentials (MEPs) recorded via concurrent Transcranial Magnetic Stimulation (TMS) and electromyography (EMG).
RESULTS


Participants perceived Multifocal-tDCS and ActiSham similarly in terms of both localization and intensity of scalp sensations, whereas traditional Bifocal stimulation was rated as more painful and annoying compared to its Sham counterpart. Additionally, differences in scalp localization were reported for active/sham Bifocal-tDCS, with Sham tDCS inducing more widespread itching and burning sensations. As for MEPs amplitude, a main effect of stimulation was found when comparing Bifocal-Sham and ActiSham (F (1,13)  = 6.67, p = .023), with higher MEPs amplitudes after the application of Bifocal-Sham.
CONCLUSIONS


Compared to traditional Bifocal-tDCS, ActiSham offers better participants' blinding by inducing very similar scalp sensations to those of real Multifocal tDCS both in terms of intensity and localization, while not affecting corticospinal excitability.",2020,"RESULTS


Participants perceived Multifocal-tDCS and ActiSham similarly in terms of both localization and intensity of scalp sensations, whereas traditional Bifocal stimulation was rated as more painful and annoying compared to its Sham counterpart.",[],"['Sham tDCS', 'Transcranial direct current stimulation (tDCS', 'placebo', 'placebo multichannel tDCS conditions']","['corticospinal excitability', 'widespread itching and burning sensations', 'presence, intensity and localization of scalp sensations', 'Motor Evoked Potentials (MEPs) recorded via concurrent Transcranial Magnetic Stimulation (TMS) and electromyography (EMG', 'scalp localization', 'localization and intensity of scalp sensations']",[],"[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",,0.101895,"RESULTS


Participants perceived Multifocal-tDCS and ActiSham similarly in terms of both localization and intensity of scalp sensations, whereas traditional Bifocal stimulation was rated as more painful and annoying compared to its Sham counterpart.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Neri', 'Affiliation': 'Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Section, University of Siena, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mencarelli', 'Affiliation': 'Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Section, University of Siena, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Menardi', 'Affiliation': 'Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Section, University of Siena, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Giovannelli', 'Affiliation': 'Section of Psychology, Department of Neuroscience, Psychology, Drug Research, Child Health, University of Florence, Florence, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': 'Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Section, University of Siena, Italy; Department of Medicine, Surgery and Neuroscience, University of Siena School of Medicine, Siena, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Sprugnoli', 'Affiliation': 'Radiology Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Department of Medicine, Surgery and Neuroscience, University of Siena School of Medicine, Siena, Italy.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salvador', 'Affiliation': 'Neuroelectrics Cambridge, MA (US) and Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Neuroelectrics Cambridge, MA (US) and Barcelona, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Santarnecchi', 'Affiliation': 'Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Section, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. Electronic address: esantarn@bidmc.harvard.edu.'}]",Brain stimulation,['10.1016/j.brs.2019.11.004']
2377,32333636,Financial toxicity of childhood cancer and changes to parents' employment after treatment completion.,"OBJECTIVE


Childhood cancer can have short- and long-term impacts on parents' finances and employment. It is important to understand how families adjust to the financial and employment changes caused by childhood cancer, the ongoing impacts after treatment completion, and which families need more targeted support. Qualitative research is necessary to facilitate an in-depth understanding of the employment and financial impacts on families and to capture parents' complex and nuanced experiences and perspectives.
METHODS


We interviewed 56 parents of childhood cancer survivors (M = 2.13 years after treatment completion; 89% mothers) using the vocational and financial impact section of the Psychosocial Adjustment to Illness Scale-Carer Interview Form. We analyzed interviews using content analysis.
RESULTS


Parents reported multiple sources of financial toxicity including travel to and from the hospital and needing to reduce their working hours during their child's cancer treatment. Workplace flexibility was an important factor to protect against unwanted vocational changes. After treatment completion, families living in low socioeconomic areas commonly reported ongoing financial difficulties. Mothers, particularly those who were on maternity leave when their child was diagnosed with cancer, reported ongoing employment impacts including unemployment.
CONCLUSIONS


Clinical staff including social workers could more consistently assess families' financial distress and refer to professional services who can offer guidance for financial decision-making as standard care. Flexible workplace agreements appear important for parents of children with cancer. Our findings can assist organizations to understand that cancer-related disruptions are likely to continue after treatment completion, and therefore should offer benefits to parents where possible.",2020,"CONCLUSIONS


Clinical staff including social workers could more consistently assess families' financial distress and refer to professional services who can offer guidance for financial decision-making as standard care.","['parents of children with cancer', '56 parents of childhood cancer survivors (M\xa0=\xa02.13 years after treatment completion; 89% mothers) using the vocational and financial impact section of the Psychosocial Adjustment to Illness Scale-Carer Interview Form']",[],"['Workplace flexibility', 'financial toxicity', 'Financial toxicity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",[],"[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0340755,"CONCLUSIONS


Clinical staff including social workers could more consistently assess families' financial distress and refer to professional services who can offer guidance for financial decision-making as standard care.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Kelada', 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wakefield', 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Vetsch', 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Centre for Economic Impacts of Genomic Medicine, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ursula M', 'Initials': 'UM', 'LastName': 'Sansom-Daly', 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hetherington', 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Cohn', 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Anazodo', 'Affiliation': ""School of Women's and Children's Health, UNSW Sydney, Kensington, New South Wales, Australia.""}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Viney', 'Affiliation': 'Centre for Health Economics Research and Evaluation, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Melanie J B', 'Initials': 'MJB', 'LastName': 'Zeppel', 'Affiliation': 'Centre for Economic Impacts of Genomic Medicine, Macquarie University, Sydney, New South Wales, Australia.'}]",Pediatric blood & cancer,['10.1002/pbc.28345']
2378,28810393,Can disclaimer labels or Dove Evolution commercial mitigate negative effects of thin-ideal exposure?,"We examined the comparative effectiveness of the Dove Evolution commercial and disclaimer labels as media literacy interventions. Women ( N = 287) viewed thin-ideal images by themselves, preceded by the Dove Evolution commercial, or containing specific or generic disclaimer labels. Participants completed pre- and post-test measures of body satisfaction, post-test social comparison, and media literacy. Interventions were not effective in mitigating drops in body satisfaction, reducing social comparison, or increasing media literacy, despite women understanding their purpose. A 2-week follow-up showed no delayed effects on media literacy. None of these interventions were effective in counteracting the negative effects of media exposure in women.",2019,"Interventions were not effective in mitigating drops in body satisfaction, reducing social comparison, or increasing media literacy, despite women understanding their purpose.",[],['Dove Evolution commercial and disclaimer labels'],"['media literacy', 'body satisfaction, post-test social comparison, and media literacy', 'body satisfaction, reducing social comparison, or increasing media literacy']",[],"[{'cui': 'C0325912', 'cui_str': 'Family Columbidae'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",287.0,0.0178737,"Interventions were not effective in mitigating drops in body satisfaction, reducing social comparison, or increasing media literacy, despite women understanding their purpose.","[{'ForeName': 'Dinusha Nc', 'Initials': 'DN', 'LastName': 'Cragg', 'Affiliation': 'University of the Sunshine Coast, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'University of the Sunshine Coast, Australia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Kannis-Dymand', 'Affiliation': 'University of the Sunshine Coast, Australia.'}]",Journal of health psychology,['10.1177/1359105317690037']
2379,28810429,Individual differences in pain sensitivity predict the experience of unfairness.,"Pain has shaped our evolutionary history, and pain-free experiences are critical for our health. There are, however, enormous individual differences in pain sensitivity, and the psychological consequences of this heterogeneity are only poorly understood. Here, we investigated whether individual differences in pain sensitivity predicted the experience of unfairness. We found that the magnitude of pain sensitivity correlated with the extent to which participants experienced unfairness. This association was due to the shared human alarm system of unfairness and pain sensitivity. This finding may elucidate mechanisms for producing a new and positive cycle of a healthy experience between fairness and feeling pain-free.",2019,We found that the magnitude of pain sensitivity correlated with the extent to which participants experienced unfairness.,[],[],['pain sensitivity'],[],[],"[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",,0.0669644,We found that the magnitude of pain sensitivity correlated with the extent to which participants experienced unfairness.,"[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Peking University, China.'}, {'ForeName': 'Kefeng', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Peking University, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Peking University, China.'}]",Journal of health psychology,['10.1177/1359105316685902']
2380,29667870,Focus is key: Panic-focused interpretations are associated with symptomatic improvement in panic-focused psychodynamic psychotherapy.,"Objective:  This study examines whether, in panic-focused psychodynamic psychotherapy (PFPP), interpretations of conflicts that underlie anxiety (panic-focused or PF-interpretations) are specifically associated with subsequent panic disorder (PD) symptom improvement, over and above the provision of non-symptom-focused interpretations.  Method:  Technique use in Sessions 2 and 10 of a 24-session PFPP protocol was assessed for the 65 patients with complete outcome data randomized to PFPP in a two-site trial of psychotherapies for PD. Sessions were rated in 15-min segments for therapists' use of PF-interpretations, non-PF-interpretations, and PF-clarifications. Robust regressions were conducted to examine the relationship between these interventions and symptom change subsequent to the sampled session. Interpersonal problems were examined as a moderator of the relationship of PF-interpretations to symptom change.  Results:  At Session 10, but not at Session 2, patients who received a higher degree of PF-interpretations experienced greater subsequent improvement in panic symptoms. Non-PF-interpretations were not predictive. Patients with more interpersonal distress benefitted particularly from the use of PF-interpretations at Session 10.  Conclusions:  By the middle phase of PFPP, panic-focused interpretations may drive subsequent improvements in panic symptoms, especially among patients with higher interpersonal distress. Interpretations of conflict absent a panic focus may not be especially helpful.",2019,"Sessions were rated in 15-min segments for therapists' use of PF-interpretations, non-PF-interpretations, and PF-clarifications.","['65 patients with complete outcome data randomized to', 'patients with higher interpersonal distress', 'Patients with more interpersonal distress']","['psychotherapies for PD', 'PFPP', 'psychodynamic psychotherapy (PFPP']","['Interpersonal problems', 'panic symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",65.0,0.0183378,"Sessions were rated in 15-min segments for therapists' use of PF-interpretations, non-PF-interpretations, and PF-clarifications.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychology, University of Pennsylvania , Philadelphia , PA , USA.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Derner School of Psychology, Adelphi University , Garden City , NY , USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Derubeis', 'Affiliation': 'Department of Psychology, University of Pennsylvania , Philadelphia , PA , USA.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychology, University of Pennsylvania , Philadelphia , PA , USA.'}, {'ForeName': 'Fredric N', 'Initials': 'FN', 'LastName': 'Busch', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College , New York , NY , USA.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Derner School of Psychology, Adelphi University , Garden City , NY , USA.'}, {'ForeName': 'Dianne L', 'Initials': 'DL', 'LastName': 'Chambless', 'Affiliation': 'Department of Psychology, University of Pennsylvania , Philadelphia , PA , USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Milrod', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College , New York , NY , USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2018.1464682']
2381,32841158,Evaluation of effectiveness of a sexuality education program for parents of male adolescents: promoting of parent-adolescent sexual communication.,"Objectives Parents play a significant role in promoting of healthy sexuality in adolescents. The purpose of the present study was to assess the effectiveness of a sexuality education intervention program to enhance parent-adolescent sexual communication. Methods This study was a randomized controlled field trial. Parents of male adolescent aged 13-16 years were recruited from eight public all-boys high schools in Karaj, Iran. A multi-stage stratified random sampling method was used and 102 parents were assigned into intervention and control groups. The recruitment and data collection process lasted from February to November 2019. Self-report demographic questionnaire and six general parenting and parent-adolescent sexual communication measures were used to assess the impact of intervention. Sexuality education program was presented for the parents of intervention group, in the form of four weekly 2-h sessions. Parents were assessed at the baseline, within one week post-intervention, and three-month follow-up to evaluate the outcome variables. The data were analyzed using the Chi-square test, two-sample t-test, general linear model analyses, and Bonferroni test. Results In terms of parent-adolescent general communication, parental monitoring, parent-adolescent communication about sex-related topics, parent's sexual communication skills, parent's self-efficacy, and responsiveness to sexual communication. There were no significant differences between intervention and control groups at the baseline (p>0.05). Compared to controls, intervention parents reported more improvement in general communication across the time; however, significant differences were not observed regarding general communication and parental monitoring (p=0.94, p=0.95). Parents in the intervention group significantly differed from those in the control group for the mean scores of parent-adolescent communication about sex-related topics (p=0.04), parent's sexual communication skills (p=0.04), parent's self-efficacy (p=0.002), and responsiveness (p<0.001) to sexual communication at each follow-up. Conclusions We identified the educational program as a promising tool for improving parent-adolescent communication regarding sexuality-related issues. This program provides the evidence for implementation of parent-based sexuality education programs.",2020,"Compared to controls, intervention parents reported more improvement in general communication across the time; however, significant differences were not observed regarding general communication and parental monitoring (p=0.94, p=0.95).","['parents of male adolescents', '102 parents', 'healthy sexuality in adolescents', 'Parents of male adolescent aged 13-16 years were recruited from eight public all-boys high schools in Karaj, Iran']","['sexuality education program', 'Self-report demographic questionnaire and six general parenting', 'sexuality education intervention program']","[""mean scores of parent-adolescent communication about sex-related topics (p=0.04), parent's sexual communication skills"", ""parent's self-efficacy"", 'general communication']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0257745,"Compared to controls, intervention parents reported more improvement in general communication across the time; however, significant differences were not observed regarding general communication and parental monitoring (p=0.94, p=0.95).","[{'ForeName': 'Shahnaz Babayanzad', 'Initials': 'SB', 'LastName': 'Ahari', 'Affiliation': 'Reproductive Health Department, School of Nursing and Midwifery, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Zahra Behboodi', 'Initials': 'ZB', 'LastName': 'Moghadam', 'Affiliation': 'Reproductive Health Department, School of Nursing and Midwifery, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Azin', 'Affiliation': 'Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Population Health Research Group, Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran.'}, {'ForeName': 'Raziyeh', 'Initials': 'R', 'LastName': 'Maasoumi', 'Affiliation': 'Reproductive Health Department, School of Nursing and Midwifery, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Pedram', 'Affiliation': 'Department of Education of Karaj, Department of Education of Alborz Province, Alborz, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2020-0079']
2382,32841169,Exploring the impact of pain management programme attendance on complex regional pain syndrome (CRPS) patients' decision making regarding immunosuppressant treatment to manage their chronic pain condition.,"Objectives Complex regional pain syndrome (CRPS) is a rare chronic pain condition for which no curative treatment exists. Patients in tertiary centres are often required to make decisions about treatment options. This study was conducted to explore how prior attendance of a pain management program might alter patients' decision making processes. Methods This qualitative study uses focus groups to gather patient views on an immunosuppressant drug treatment (mycophenolate) for the management of CRPS. Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP. Outcomes were considered within the framework of Leventhal's Common Sense Model (CSM) in relation to the decision making process. Results Thematic analysis identified differing themes for each group. Group 1: (1) Medication as a positive form of treatment, (2) The trial/drug and (3) Pacing. Group 2: (1) Medication as form of treatment, (2) Other forms of support/treatment and (3) Side effects of mycophenolate. Group 3: (1) Varied view of medication, (2) Consideration of other forms of support and (3) Side effects. Conclusions Attendance on a PMP might provide patients with skills to better manage uncertainty when faced with various treatment options. Leventhal's model goes some way to explaining this. The specific importance of, and benefit from understanding pacing when commencing an effective drug treatment for chronic pain became apparent.",2020,Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP.,['complex regional pain syndrome (CRPS) patients'],"['immunosuppressant drug treatment (mycophenolate', 'pain management programme attendance', 'mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP', 'pain management program', 'mycophenolate']",[],"[{'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],6.0,0.0247237,Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP.,"[{'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goebel', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Twiddy', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ,UK.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0142']
2383,32841219,Fc receptor-like 5 and anti-CD20 treatment response in granulomatosis with polyangiitis and microscopic polyangiitis.,"BACKGROUND


Baseline expression of FCRL5, a marker of naïve and memory B cells, was shown to predict response to rituximab (RTX) in rheumatoid arthritis. This study investigated baseline expression of FCRL5 as a potential biomarker of clinical response to RTX in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
METHODS


A previously validated RT-qPCR-based platform was used to assess FCRL5 expression in patients with GPA/MPA (RAVE trial, NCT00104299).
RESULTS


Baseline FCRL5 expression was significantly higher in patients achieving complete response (CR) at 6, 12, and 18 months, independent of other clinical and serological variables, among those randomized to RTX but not CYC/AZA. Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared to FCRL5low subjects (84% vs 57% p=0.016, 68% vs 40% p=0.02 and 68% vs 29% p=0.0009, respectively).
CONCLUSION


Our data taken together suggest that FCRL5 is a biomarker of B cell lineage associated with increased achievement and maintenance of complete remission among patients treated with RTX and warrant further investigation in a prospective manner.",2020,"Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared to FCRL5low subjects (84% vs 57% p=0.016, 68% vs 40% p=0.02 and 68% vs 29% p=0.0009, respectively).
","['granulomatosis with polyangiitis and microscopic polyangiitis', 'granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA', 'patients with GPA/MPA (RAVE trial, NCT00104299']","['RTX', 'FCRL5', 'rituximab (RTX']","['FCRL5 expression', 'Baseline FCRL5 expression', 'CR rates']","[{'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0968435', 'cui_str': 'FCRL5 protein, human'}]","[{'cui': 'C0968435', 'cui_str': 'FCRL5 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.0755829,"Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared to FCRL5low subjects (84% vs 57% p=0.016, 68% vs 40% p=0.02 and 68% vs 29% p=0.0009, respectively).
","[{'ForeName': 'Kasia', 'Initials': 'K', 'LastName': 'Owczarczyk', 'Affiliation': ""Department of Cancer Imaging, King's College London, London, United Kingdom.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Cascino', 'Affiliation': 'Genentech Inc, South San Francisco, United States of America.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Holweg', 'Affiliation': 'Medical Affairs, Genentech Inc, San Francisco, United States of America.'}, {'ForeName': 'Gaik W', 'Initials': 'GW', 'LastName': 'Tew', 'Affiliation': 'Genentech Inc, South San Francisco, United States of America.'}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Ortmann', 'Affiliation': 'Genentech Inc, South San Francisco, United States of America.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Behrens', 'Affiliation': 'Department of Medicine, Genentech Inc, San Francisco, United States of America.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic, Cleveland, United States of America.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Department of Medicine, Rheumatology Allergy and Clinical Immunology, Duke University Medical Center, Durham, United States of America.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'Department of Rheumatology, The University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Department of Medicine, Hospital for Special Surgery, New York, United States of America.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Seo', 'Affiliation': 'The Johns Hopkins Vasculitis Center, Johns Hopkins University, Baltimore, United States of America.'}, {'ForeName': 'Cees Gm', 'Initials': 'CG', 'LastName': 'Kallenberg', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'College of Medicine and Science, Mayo Clinic, Rochester, United States of America.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Lim', 'Affiliation': 'Immune Tolerance Network, Seattle, United States of America.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': 'Department of Rheumatology, Massachusetts General Hospital, Boston, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brunetta', 'Affiliation': 'Genentech Inc, South San Francisco, United States of America.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Prunotto', 'Affiliation': 'Genentech Inc, South San Francisco, United States of America.'}]",JCI insight,['10.1172/jci.insight.136180']
2384,32841256,"The efficacy of a compounded micronutrient supplement on the incidence, duration, and severity of the common cold: A pilot randomized, double-blinded, placebo-controlled trial.","PURPOSE


Viral upper respiratory infections are associated with significant health and economic impact. This study sought to determine the efficacy of routine immune system micronutrient supplementation on the incidence, duration and severity of common cold symptoms.
METHODS


This pilot study was a randomized, double-blinded, placebo-controlled trial of N = 259 with asymptomatic participants aged 18 to 65 in two cold seasons of 2016 and 2017. The treatment group received an immune system targeted micronutrient caplet, while the placebo group received a micronized cellulose caplet externally identical to the treatment caplet. Weekly surveys were sent electronically to participants to document common cold incidence, duration and severity. Primary statistical results were obtained using mixed-effects logistic regressions to account for longitudinal measurements for participants.
RESULTS


The odds of acquiring an upper respiratory infection, adjusted for potential confounders, was estimated to be 0.74 times lower in the treatment group (p = 0.14). The odds of reporting specific symptoms were statistically lower in the treatment arm compared to the placebo arm for runny nose (OR = 0.53, p = 0.01) and cough (OR = 0.51, p = 0.04). Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05). There was no significant difference in severity of symptoms in either group. The observed proportion of reported cold symptoms in the treatment group was lower compared to the placebo group between late January and February in two consecutive cold seasons. Given the physical, workplace and economic impact of upper respiratory infections, this low cost and low risk intervention should be further studied with more robust investigation and meticulous experimental design.",2020,Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05).,['N = 259 with asymptomatic participants aged 18 to 65 in two cold seasons of 2016 and 2017'],"['micronutrient supplement', 'micronized cellulose caplet externally identical to the treatment caplet', 'placebo', 'immune system targeted micronutrient caplet, while the placebo', 'routine immune system micronutrient supplementation']","['cough', 'severity of symptoms', 'incidence, duration, and severity of the common cold', 'cold symptoms', 'odds of reporting specific symptoms', 'Shorter durations of runny nose and cough']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020962', 'cui_str': 'Structure of immune system'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0863093', 'cui_str': 'Cold symptoms'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}]",2.0,0.394248,Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05).,"[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Lenhart', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Kale', 'Initials': 'K', 'LastName': 'Quackenbush', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'LaPorte', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0237491']
2385,32841261,Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6.,"BACKGROUND/PURPOSE


To date, studies examining polymicrobial infections in ocular disease have mostly been limited to keratitis or endophthalmitis. We characterized polybacterial infections compared to monobacterial infections in prior clinical studies evaluating besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial conjunctivitis and report on associated microbiological outcomes.
METHODS


In this post-hoc analysis, microbiological data for subjects with conjunctivitis due to one or more than one bacterial species in three previous studies (two vehicle-, one active-controlled) of besifloxacin were extracted. Bacterial species identified at baseline were deemed causative if their colony count equaled or exceeded species-specific prespecified threshold criteria. In subjects with polybacterial infections, the fold-increase over threshold was used to rank order the contribution of individual species. Baseline pathogens and their minimum inhibitory concentrations (MICs) for common ophthalmic antibiotics were compared by infection type, as were microbial eradication rates following treatment with besifloxacin.
RESULTS


Of 1041 subjects with culture-confirmed conjunctivitis, 17% had polybacterial and 83% had monobacterial conjunctivitis at baseline. In polybacterial compared to monobacterial infections, Haemophilus influenzae and Streptococcus pneumoniae were identified less frequently as the dominant infecting species (P = 0.042 and P<0.001, respectively), whereas Streptococcus mitis/S. mitis group was identified more frequently as dominant (P<0.001). Viral coinfection was also identified more frequently in polybacterial infections (P<0.001). Staphylococcus aureus was the most common coinfecting species in polybacterial infections and the second most common dominant species in such infections. With few exceptions, MICs for individual species were comparable regardless of infection type. Clinical microbial eradication rates with besifloxacin were high regardless of infection type (P≤0.016 vs vehicle at follow-up visits).
CONCLUSIONS


Approximately one in five subjects with bacterial conjunctivitis are infected with more than one bacterial species underscoring the need for a broad-spectrum antibiotic for such infections. Besifloxacin treatment resulted in robust eradication rates of these infections comparable to monobacterial infections.
TRIAL REGISTRATION


NCT000622908, NCT00347932, NCT00348348.",2020,Viral coinfection was also identified more frequently in polybacterial infections (P<0.001).,"['subjects with conjunctivitis', '1041 subjects with culture-confirmed conjunctivitis, 17% had polybacterial and 83% had monobacterial conjunctivitis at baseline']","['besifloxacin ophthalmic suspension', 'Besifloxacin', 'besifloxacin ophthalmic suspension 0.6', 'besifloxacin']","['microbial eradication rates', 'Viral coinfection']","[{'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C2700743', 'cui_str': 'besifloxacin Ophthalmic Suspension'}, {'cui': 'C2351042', 'cui_str': 'besifloxacin'}, {'cui': 'C4068883', 'cui_str': '0.6'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}]",1041.0,0.0485752,Viral coinfection was also identified more frequently in polybacterial infections (P<0.001).,"[{'ForeName': 'Heleen H', 'Initials': 'HH', 'LastName': 'DeCory', 'Affiliation': 'Medical Affairs, Bausch + Lomb, Rochester, New York, United States of America.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Sanfilippo', 'Affiliation': 'Medical Affairs, Bausch + Lomb, Rochester, New York, United States of America.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin & Associates, Rochester, New York, United States of America.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Blondeau', 'Affiliation': 'Clinical Microbiology, Royal University Hospital, Saskatoon, Saskatchewan, Canada.'}]",PloS one,['10.1371/journal.pone.0237603']
2386,32841725,"A commentary on ""Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" (Int. J. Surg. 2020; 80:13-18).",,2020,,['elderly patients undergoing hip joint replacement surgery'],['edaravone'],['postoperative cognitive function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Zhao-Jing', 'Initials': 'ZJ', 'LastName': 'Xue', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's China.""}, {'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's China. Electronic address: xuefushan@aliyun.com.""}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Yuan', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's China.""}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.020']
2387,32841748,Improvements in Quality of Life in Children Following Epicutaneous Immunotherapy (EPIT) for Peanut Allergy in the PEPITES and PEOPLE Studies.,"BACKGROUND


Food allergy quality of life (FAQL) is impaired in children with peanut allergy. Food CAllergy Quality of Life Questionnaires (FAQLQs) provide disease-specific insight into the burden of peanut allergy and potential FAQL changes following peanut immunotherapy.
OBJECTIVE


To examine FAQL changes in children following treatment with epicutaneous immunotherapy (EPIT) for peanut allergy (250μg, daily epicutaneous peanut protein; DBV712 250μg).
METHODS


FAQL was prospectively measured using the FAQLQ parent proxy form (FAQLQ-PF, for children aged ≤12 years) and child form (FAQLQ-CF, child rated if aged ≥8 years) during the 12-month double-blind, randomized, controlled PEPITES trial and the initial 12 months of the open-label PEOPLE follow-up study. Data were analyzed for between-group differences after treatment unblinding.
RESULTS


FAQLQ from placebo participants (-PF: 96; -CF: 47) and treatment group participants (-PF: 209; -CF: 105) were analyzed. Twenty-four-month global FAQL scores (FAQLQ-PF/CF) were significantly improved in the treatment versus placebo group (least squares [LS] mean 0.34, P=0.008 and 0.46, P=0.023, respectively). At 24 months, there was significant FAQLQ-PF score improvement in participants initially randomized to treatment who met the efficacy primary endpoint (n=74, LS mean 0.55, P<0.001) and in participants with any eliciting dose increase (n=127, LS mean 0.66, P<0.001). FAQLQ-PF improvements were observed in social dietary limitations (P=0.002), food-related anxiety (P=0.029), and emotional impact (P=0.048) domains. FAQLQ-CF improvements were observed in risk of accidental exposure (P=0.002) and allergen avoidance (P=0.04) domains. Nearly all outcomes met a non-treatment context MCID previously cited for FAQLQ.
CONCLUSION


EPIT treatment was observed to be associated with significant global and domain-specific FAQL improvement (FAQLQ-PF/-CF), largely driven by increases in eliciting dose, in children with peanut allergy.",2020,"PF improvements were observed in social dietary limitations (P=0.002), food-related anxiety (P=0.029), and emotional impact (P=0.048) domains.","['children with peanut allergy', '47) and treatment group participants (-PF: 209', 'children following treatment with', 'children aged ≤12 years) and child form (FAQLQ-CF, child rated if aged ≥8 years', 'participants']","['FAQLQ', 'CF', 'epicutaneous immunotherapy (EPIT', 'Epicutaneous Immunotherapy (EPIT', 'placebo']","['Food CAllergy Quality of Life Questionnaires (FAQLQs', 'allergen avoidance', 'significant global and domain-specific FAQL improvement (FAQLQ-PF/-CF', 'Quality of Life', 'emotional impact', 'global FAQL scores (FAQLQ-PF/CF', 'risk of accidental exposure', 'FAQLQ-PF score improvement', 'food-related anxiety', 'social dietary limitations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0450027', 'cui_str': 'Accidental exposure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.357737,"PF improvements were observed in social dietary limitations (P=0.002), food-related anxiety (P=0.029), and emotional impact (P=0.048) domains.","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'School of Applied Psychology, University College Cork, Ireland; Paediatrics and Infectious Disease Department of Sechenov University, First Moscow State Medical University, Russia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ""Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ""Children's Hospital at Westmead, Sydney, Australia; DBV Technologies, Montrouge, France.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': ""O'B Hourihane"", 'Affiliation': 'Paediatrics and Child Health, University College Cork, Ireland; Paediatrics and Child Health, Royal College of Surgeons in Ireland.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': ""DBV Technologies, Montrouge, France; UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, CO, USA. Electronic address: Matthew.Greenhawt@childrenscolorado.org.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.015']
2388,32841751,Photodynamic therapy versus candida antigen immunotherapy in plane wart treatment: a comparative controlled study.,"INTRODUCTION


Plane warts, mostly found on the face, present a challenge to treat as most destructive methods can lead to unpleasant cosmetic outcome. Alternative therapeutic methods other than destructive should be evaluated. The aim is to evaluate the clinical efficacy and adverse effects of photodynamic therapy with methylene blue and intense pulsed light in comparison to candida antigen immunotherapy in the treatment of plane warts.
METHODS


The study included 39 patients with plane warts assigned into 3 groups. Group I received photodynamic therapy using methylene blue followed by IPL illumination, group II received immunotherapy using 0.1 ml of candida albicans antigen and group III received 0.1 ml saline as a control.
RESULTS


Complete response was detected in (46.1%) of patients in group I compared to (61.5%) in group II and no response in group III.
CONCLUSION


Candida antigen immunotherapy is superior to photodynamic therapy in plane warts treatment with absence of recurrence and comparable side effects in both groups.",2020,"CONCLUSION


Candida antigen immunotherapy is superior to photodynamic therapy in plane warts treatment with absence of recurrence and comparable side effects in both groups.",['39 patients with plane warts assigned into 3 groups'],"['photodynamic therapy using methylene blue followed by IPL illumination, group II received immunotherapy using 0.1\u2009ml of candida albicans antigen and group III received 0.1\u2009ml saline', 'Photodynamic therapy versus candida antigen immunotherapy', 'photodynamic therapy with methylene blue and intense pulsed light']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0276262', 'cui_str': 'Plane wart'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0006837', 'cui_str': 'Candida albicans'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",[],39.0,0.0188971,"CONCLUSION


Candida antigen immunotherapy is superior to photodynamic therapy in plane warts treatment with absence of recurrence and comparable side effects in both groups.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nassar', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, 44519, Egypt. Electronic address: dramany_nassar@yahoo.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, 44519, Egypt. Electronic address: maha.most92@gmail.com.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Khashaba', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, 44519, Egypt. Electronic address: shrook_Khashaba@yahoo.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101973']
2389,32841825,A randomized study of CrossFit Kids for fostering fitness and academic outcomes in middle school students.,"Within the context of school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK) has emerged as a potential intervention for positively impacting students. The purpose of this study was to evaluate through a randomized-controlled trial how academic and health-related fitness outcomes differed for middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72). Questionnaire data were collected twice across the 9-month academic year and combined with FitnessGram and grade data. Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055]. Significant gender by time interaction effects were found for the relationship between CFK or PE participation and health-related fitness outcomes, but there were no significant interaction effects by gender on academic outcomes. Because developmental outcomes are conditional and result from the coaction of many factors, the findings suggest that some elements of CFK might be beneficial to build skills yet disadvantageous to academic outcomes.",2020,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","['middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72', 'middle school students']","['school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK', 'CrossFit Kids']","['health-related fitness outcomes', 'Questionnaire data', 'fostering fitness and academic outcomes']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}]",,0.0283754,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","[{'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Garst', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA. Electronic address: bgarst@clemson.edu.'}, {'ForeName': 'Edmond P', 'Initials': 'EP', 'LastName': 'Bowers', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Stephens', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2020.101856']
2390,32841846,Decreased functional connectivity within the salience network after two-week morning bright light exposure in individuals with sleep disturbances: a preliminary randomized controlled trial.,"BACKGROUND


Bright light (BL) exposure is a safe non-pharmacological intervention for sleep disturbances. However, the functional brain correlates underlying the effects of bright light exposure need to be further clarified. As alterations in the salience network were reported in individuals with sleep disturbances, we have investigated whether bright light exposure may improve sleep quality by altering functional connectivity in this network.
METHODS


In the current study, 30 individuals with sleep disturbances were randomly assigned to one of the two interventions for two weeks: (1) 1 h of bright light (10,000 lux) exposure (BL-exposed group) and (2) 1 h of dim light (<300 lux) exposure (DL-exposed group). Sleep characteristics and functional connectivity in the salience network were assessed by sleep diary and resting-state functional magnetic resonance imaging, respectively, as outcome measures at before and after the intervention.
RESULTS


After two weeks of the intervention, the BL-exposed group showed greater improvement with respect to sleep efficiency (t = 2.27, p = 0.03) and sleep latency (t = -2.40, p = 0.03) as compared to the DL-exposed group. In addition, functional connectivity decreased in the cluster that encompasses the right anterior insular and the frontal opercular regions in the salience network (uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group. Decreased functional connectivity in the cluster was associated with decreased sleep latency in the BL-exposed group (β = 0.54, p = 0.01).
CONCLUSIONS


Our results suggest that bright light exposure may improve sleep quality in individuals with sleep disturbances by modulating functional connectivity in the salience network.
CLINICAL TRIAL REGISTRATION


https://cris.nih.go.kr/cris; KCT0002607.",2020,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","['individuals with sleep disturbances', '30 individuals with sleep disturbances']","['bright light (10,000 lux) exposure (BL-exposed group) and', 'Bright light (BL) exposure', 'bright light exposure']","['sleep efficiency', 'functional connectivity', 'Decreased functional connectivity', 'sleep latency', 'sleep quality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",30.0,0.0552621,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Myeongju', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Gahae', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Soo Mee', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Department of Radiology, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'In Kyoon', 'Initials': 'IK', 'LastName': 'Lyoo', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Graduate School of Pharmaceutical Sciences, Ewha W. University, Seoul, South Korea; Department of Psychiatry, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: sujungjyoon@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.05.009']
2391,32843512,Avoidance of Routine Endotracheal Suction in Subjects Ventilated for ≤ 12 h Following Elective Cardiac Surgery.,"BACKGROUND


Mechanical ventilation requires an endotracheal tube. Airway management includes endotracheal suctioning, a frequent procedure for patients in the ICU. Associated risks of endotracheal suctioning include hypoxia, atelectasis, and infection. There is currently no evidence about the safety of avoiding endotracheal suction. We aimed to assess the safety of avoiding endotracheal suction, including at extubation, in cardiac surgical patients who were mechanically ventilated for ≤ 12 h.
METHODS


We conducted a single-center, noninferiority, randomized controlled trial in a cardiac ICU in a metropolitan tertiary teaching hospital. Subjects were assigned to either avoidance of endotracheal suction or to usual care including endotracheal suctioning during mechanical ventilation. In total, we screened 468 patients and randomized 249 subjects (usual care,  n  = 125; intervention,  n  = 124). Subjects were elective cardiac surgical patients anticipated to receive ≤ 12 h of mechanical ventilation. The primary outcome was the P aO 2  /F IO 2  on room air 6 h after extubation, with a noninferiority margin of 10% (lower bound of one-sided 95% CI to be < 30).
RESULTS


There were no differences in group characteristics at baseline. The primary analysis was a per-protocol analysis performed on 154 subjects. The median P aO 2  /F IO 2  was 323 for the intervention group and 311 for the standard care group (median difference = 12, one-sided 95% CI -14.3). The results were consistent when using an intention-to-treat analysis and a 97.5% CI. There were no differences between groups in complications or safety measures, including the escalation of oxygen therapy.
CONCLUSIONS


Endotracheal suctioning can be safely minimized or avoided in low-risk patients who have had cardiac surgery and are expected to be ventilated for < 12 h after surgery.",2020,"The median P aO 2  /F IO 2  was 323 for the intervention group and 311 for the standard care group (median difference = 12, one-sided 95% CI -14.3).","['Subjects were elective cardiac surgical patients', 'patients in the ICU', 'cardiac surgical patients who were mechanically ventilated for ≤ 12 h', 'low-risk patients who have had cardiac surgery', 'Subjects Ventilated for ≤ 12 h Following Elective Cardiac Surgery', '468 patients and randomized 249 subjects (usual care,  n  = 125; intervention,  n  = 124', 'in a metropolitan tertiary teaching hospital']","['Routine Endotracheal Suction', 'mechanical ventilation', 'cardiac ICU', 'Endotracheal suctioning', 'avoidance of endotracheal suction or to usual care including endotracheal suctioning during mechanical ventilation', 'avoiding endotracheal suction']","['P aO 2  /F', 'Associated risks of endotracheal suctioning include hypoxia, atelectasis, and infection', 'median P aO 2  /F IO 2', 'escalation of oxygen therapy']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",249.0,0.205083,"The median P aO 2  /F IO 2  was 323 for the intervention group and 311 for the standard care group (median difference = 12, one-sided 95% CI -14.3).","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Gilder', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Grafton, Auckland, New Zealand. egilder@adhb.govt.nz.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Cavadino', 'Affiliation': 'School of Population Health, University of Auckland, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jull', 'Affiliation': 'School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Grafton, Auckland, New Zealand.'}]",Respiratory care,['10.4187/respcare.07821']
2392,32843515,"Ultrasound-guided bilateral pudendal nerve blocks of nulliparous women with epidural labour analgesia in the second stage of labour: a randomised, double-blind, controlled trial.","OBJECTIVE


To explore whether an ultrasound-guided pudendal nerve block (PNB) could decrease anaesthetic use, thereby shortening the length of the second stage of labour in women undergoing epidural analgesia.
DESIGN


Prospective, single-centre, randomised, double-blind, controlled trial.
SETTING


An obstetric centre in a general hospital in China.
PARTICIPANTS


72 nulliparous women were randomised, and 71 women completed the study.
INTERVENTION


An ultrasound-guided bilateral PNB was administered to all study participants; the PNB group were given 0.25% ropivacaine 10 mL, while the control group were given 10 mL saline.
MAIN OUTCOME MEASURE


The primary outcome measure was the duration of the second stage of labour. Secondary outcomes included additional bolus administration, total hourly bupivacaine consumption, difference in thickness between the contracted and relaxed rectus abdominis muscle before (DRAM1) and 30 min after (DRAM2) PNB, urge to defecate, maternal cooperation, preservation of the lower limb motor function, tightness of the perineum, and Numeric Rating Scale (NRS) score for pain.
RESULTS


The duration of the second stage of labour was shorter in the PNB group than in the control group (difference of 33.8 min (95% CI 15.6 to 52.0), p<0.001). Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001). DRAM2 was greater (p<0.001), rate of parturient women with the urge to defecate was higher (p=0.014), maternal cooperation was superior (p=0.002), and lower limb motor function preservation was greater (p=0.004) in the PNB group relative to the control group. Tightness of the perineum was eliminated from the results due to the inconsistent application of the criteria by the nursing staff. There was no significant difference in NRS scores between the groups.
CONCLUSIONS


Nulliparous women with epidural analgesia who received an ultrasound-guided bilateral PNB may reduce their need for bupivacaine and consequently shorten the length of the second stage of labour, therein indicating that a bilateral PNB may serve as an additional effective adjunct method of labour analgesia.
TRIAL REGISTRATION NUMBER


ChiCTR-IOR-16009121.",2020,Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001).,"['nulliparous women with epidural labour analgesia in the second stage of labour', 'women undergoing epidural analgesia', 'An obstetric centre in a general hospital in China', '72 nulliparous women were randomised, and 71 women completed the study', 'Nulliparous women with epidural analgesia who received an']","['bupivacaine', 'Ultrasound-guided bilateral pudendal nerve blocks', 'ultrasound-guided bilateral PNB', 'ultrasound-guided pudendal nerve block (PNB', 'ropivacaine 10\u2009mL, while the control group were given 10\u2009mL saline']","['additional bolus administration, total hourly bupivacaine consumption, difference in thickness between the contracted and relaxed rectus abdominis muscle before (DRAM1) and 30\u2009min after (DRAM2) PNB, urge to defecate, maternal cooperation, preservation of the lower limb motor function, tightness of the perineum, and Numeric Rating Scale (NRS) score for pain', 'maternal cooperation', 'total hourly bupivacaine consumption', 'rate of parturient women with the urge to defecate', 'NRS scores', 'duration of the second stage of labour', 'DRAM2', 'lower limb motor function preservation']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}]",72.0,0.379508,Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001).,"[{'ForeName': 'Jialing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Obstetrics and Gynecology, Zhejiang University School of Medicine Women's Hospital, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Riyong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Weijue', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': ""Department of Obstetrics and Gynecology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Papadimos', 'Affiliation': 'Department of Anesthesiology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Junzhao', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China z.joyce08@163.com xuzhong@263.net.""}, {'ForeName': 'Xuzhong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China z.joyce08@163.com xuzhong@263.net.'}]",BMJ open,['10.1136/bmjopen-2019-035887']
2393,32843517,CASNET2: evaluation of an electronic safety netting cancer toolkit for the primary care electronic health record: protocol for a pragmatic stepped-wedge RCT.,"INTRODUCTION


Safety-netting in primary care is the best practice in cancer diagnosis, ensuring that patients are followed up until symptoms are explained or have resolved. Currently, clinicians use haphazard manual solutions. The ubiquitous use of electronic health records provides an opportunity to standardise safety-netting practices.A new electronic safety-netting toolkit has been introduced to provide systematic ways to track and follow up patients. We will evaluate the effectiveness of this toolkit, which is embedded in a major primary care clinical system in England:Egerton Medical Information System(EMIS)-Web.
METHODS AND ANALYSIS


We will conduct a stepped-wedge cluster RCT in 60 general practices within the RCGP Research and Surveillance Centre (RSC) network. Groups of 10 practices will be randomised into the active phase at 2-monthly intervals over 12 months. All practices will be activated for at least 2 months. The primary outcome is the primary care interval measured as days between the first recorded symptom of cancer (within the year prior to diagnosis) and the subsequent referral to secondary care. Other outcomes include referrals rates and rates of direct access cancer investigation.Analysis of the clustered stepped-wedge design will model associations using a fixed effect for intervention condition of the cluster at each time step, a fixed effect for time and other covariates, and then include a random effect for practice and for patient to account for correlation between observations from the same centre and from the same participant.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the North West-Greater Manchester West National Health Service Research Ethics Committee (REC Reference 19/NW/0692). Results will be disseminated in peer-reviewed journals and conferences, and sent to participating practices. They will be published on the University of Oxford Nuffield Department of Primary Care and RCGP RSC websites.
TRIAL REGISTRATION NUMBER


ISRCTN15913081; Pre-results.",2020,"We will evaluate the effectiveness of this toolkit, which is embedded in a major primary care clinical system in England:Egerton Medical Information System(EMIS)-Web.
",['60 general practices within the RCGP Research and Surveillance Centre (RSC) network'],['CASNET2'],"['referrals rates and rates of direct access cancer investigation', 'primary care interval measured as days between the first recorded symptom of cancer (within the year prior to diagnosis) and the subsequent referral to secondary care']","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",[],"[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}]",60.0,0.193035,"We will evaluate the effectiveness of this toolkit, which is embedded in a major primary care clinical system in England:Egerton Medical Information System(EMIS)-Web.
","[{'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Fleming', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Nicholson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK brian.nicholson@phc.ox.ac.uk.'}, {'ForeName': 'Afsana', 'Initials': 'A', 'LastName': 'Bhuiya', 'Affiliation': 'North Central and East London Cancer Alliance, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perera', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sherlock', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ivelina', 'Initials': 'I', 'LastName': 'Yonova', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Bankhead', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038562']
2394,32842188,"[Efficacy and safety of pulmicort repulas-impregnated nasal dressing following endoscopic sinus surgery: a randomized, single-blind, placebo-controlled study].","Objective: To investigate the efficacy and safety of pulmicort respulas immerse with nasopore as nasal packing after nasal endoscopic surgery on patients with chronic rhinosinusitis with nasal polyps.  Method: This single-blind, randomized study recruit 33 patients diagnosed as chronic rhinosinusitis with polyposis. All of them underwent bilateral endoscopic sinus surgery and randomized to receive pulmicort respulas immersed nasopore in one nasal cavity and saline immersed nasopore contralaterally. Both groups were followed up at 2, 4, 8, 12, 24 weeks after operation. Subjective （VAS score） and objective （Lund-Kennedy score） scores are collected at each time point from both sides of nasal cavity.  Result: There are 30 enrolled patients in the study completed the 24-week trial. Both the subjective and objective scores of two groups shows a significant reduction after the ESS operation. The VAS score of the two groups remains roughly unchanged during week 2 to week 24. A statistically significant difference of the Lund-Kennedy score can be detected between the groups from week 2 to week 24. Though the serum cortisol reduced （5.97±4.10） mmol/L vs （12.48±4.33） mmol/L after the surgery, neither group shows any clinical symptoms related with the hypothalamic-pituitary-adrenal axis suppression.  Conclusion: This study demonstrated a significant improvement in postoperative healing in nasal cavities receiving pulmicort respulas immersed nasopore as nasal packing following ESS. This method of using budesonide is generally safe for patients with chronic rhinosinusitis with polyposis.",2020,A statistically significant difference of the Lund-Kennedy score can be detected between the groups from week 2 to week 24.,"['patients with chronic rhinosinusitis with polyposis', '33 patients diagnosed as chronic rhinosinusitis with polyposis', '30 enrolled patients in the study completed the 24-week trial', 'endoscopic sinus surgery', 'patients with chronic rhinosinusitis with nasal polyps']","['pulmicort repulas-impregnated nasal dressing', 'pulmicort respulas immersed nasopore in one nasal cavity and saline immersed nasopore contralaterally', 'bilateral endoscopic sinus surgery', 'budesonide', 'placebo', 'pulmicort respulas immerse with nasopore as nasal packing after nasal endoscopic surgery']","['Lund-Kennedy score', 'efficacy and safety', 'VAS score', 'serum cortisol', 'postoperative healing', 'Subjective （VAS score） and objective （Lund-Kennedy score） scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0678162', 'cui_str': 'Pulmicort'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",33.0,0.0277363,A statistically significant difference of the Lund-Kennedy score can be detected between the groups from week 2 to week 24.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Zhenxiao', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Mingjie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Nianci', 'Initials': 'N', 'LastName': 'Xiao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.06.015']
2395,32842203,[Clinical efficacy of proton pump inhibitor combined with ranitidine in the treatment of throat reflux].,"Objective: To investigate the clinical effect of proton pump inhibitor combined with ranitidine on patients with laryngopharyngeal reflux.  Method: Seventy patients with laryngopharyngeal reflux diagnosed in our hospital were randomly divided into group A and group B according to admission time. The difference of B symptom index, reflux symptom scale, sleep breathing test, quality of life and well-being score between the two groups were detected.  Result: Before treatment, the RSI index, RFS similarity and QOLS and MUNSH scores were similar （ P >0.05）. After four weeks of treatment, the group B score was 3.3±1.2, the group A score was 8.2±3.5, and the group B score was significantly lower. The RFS score of group A （6.2±2.3） was higher than that of group B （2.1±1.9,  P <0.05）. The scores of QOLS and MUNSH in group B were （67.57±7.26） and （23.99±3.44）, respectively. The scores of QOLS and MUNSH in group A （50.13±10.19） and （12.21±1.47）, respectively. The results of the two groups were significantly different （ P <0.05）. After treatment, the RSI index, RFS score, QOLS and MUNSH scores of the two groups were lower than those before treatment. （ P <0.05）. As for the sleep respiration monitoring （PSG） results, after 4-week treatment, compared with the group A, the total sleep time of the group B was significantly increased （ P <0.05）, and the number of wakefulness and wakefulness was significantly decreased. The duration of Ⅲ+Ⅳ sleep was also significantly increased, and the proportion of REM sleep time and AHI was significantly reduced （ P <0.05）.  Conclusion: Proton pump inhibitor combined with ranitidine is more effective and safer than single drug treatment, and can significantly improve the throat reflux symptoms.",2020,"Before treatment, the RSI index, RFS similarity and QOLS and MUNSH scores were similar （ P >0.05）.","['patients with laryngopharyngeal reflux', 'throat reflux', 'Method: Seventy patients with laryngopharyngeal reflux diagnosed in our hospital']","['ranitidine', 'proton pump inhibitor combined with ranitidine']","['B symptom index, reflux symptom scale, sleep breathing test, quality of life and well-being score', 'proportion of REM sleep time and AHI', 'scores of QOLS and MUNSH', 'throat reflux symptoms', 'RFS score', 'RSI index, RFS score, QOLS and MUNSH scores', 'number of wakefulness and wakefulness', 'RSI index, RFS similarity and QOLS and MUNSH scores', 'duration of Ⅲ+Ⅳ sleep', 'total sleep time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168250', 'cui_str': 'Laryngopharyngeal reflux'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0034665', 'cui_str': 'Ranitidine'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0035127', 'cui_str': 'Repetitive strain injury'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",70.0,0.0210271,"Before treatment, the RSI index, RFS similarity and QOLS and MUNSH scores were similar （ P >0.05）.","[{'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology，Shaoxing Central Hospital，Shaoxing，312030，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.08.008']
2396,32842225,[A comparative study on treatment of severe OSA with UPPP combined with endoscopic low-temperature plasma tongue root resection].,"Objective: The aim of this study is to investigate the effect of modified uvulopalatopharyngoplasty （UPPP） combined with endoscopic hypothermic Plasma glossectomy （Eco-TBR） on the severe Obstructive sleep apnea syndrome.  Method: Sixty patients with severe OSAHS were diagnosed by polysomnography, and their obstructive plane located in the oropharynx and tongue base. Patients were divided into the control group （30 cases of simple H-UPPP） and the experimental group （30 cases of H-UPPP combined with Eco-TBR） according to their random hospital sequence. SPSS 20.0 software package was used to analyze the preoperative and postoperative data of the two groups.  Result: Fifty-seven OSAHS patients had full data and a minimum 6 month follow up to assess the efficacy. The total effective rate in the control group was 41.38% lower than that in the experimental group 67.85%, and the difference was statistically significant （χ²=4.03,  P <0.05）. The postoperative data of the control group, AHI was 28.07±10.283, LSaO2 was 72.660±6.405, ESS was 12.620±2.731, and snoring VAS were 3.93±1.307. After the operation, in the experimental group, AHI was 25.74±14.140, LSaO2 was 75.360±7.299, ESS was 11.320±3.209, and snoring VAS were 3.00±1.305. The differences in AHI, LSaO2, ESS and snoring VAS before and after surgery in the two groups were statistically significant （ P <0.001）. After surgery, compared between the two groups, except for snoring VAS, the differences of AHI, LSaO2 and ESS were not statistically significant（ P >0.05）.  Conclusion: The effect of H-UPPP combined with Eco-TBR on severe OSAHS patients with obstructive plane of oropharynx and tongue root is definite.",2020,"The total effective rate in the control group was 41.38% lower than that in the experimental group 67.85%, and the difference was statistically significant （χ²=4.03,  P <0.05）.","['severe Obstructive sleep apnea syndrome', 'severe OSAHS patients with obstructive plane of oropharynx and tongue root is definite', 'Sixty patients with severe OSAHS were diagnosed by polysomnography, and their obstructive plane located in the oropharynx and tongue base']","['UPPP combined with endoscopic low-temperature plasma tongue root resection', 'H-UPPP combined with Eco-TBR', 'modified uvulopalatopharyngoplasty （UPPP） combined with endoscopic hypothermic Plasma glossectomy （Eco-TBR）', 'control group （30 cases of simple H-UPPP） and the experimental group （30 cases of H-UPPP combined with Eco-TBR']","['AHI, LSaO\ue00c2, ESS and snoring VAS', 'total effective rate', 'snoring VAS', 'LSaO\ue00c2', 'AHI, LSaO\ue00c2 and ESS']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0226956', 'cui_str': 'Structure of pharyngeal portion of dorsum of tongue'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0226958', 'cui_str': 'Structure of root of tongue'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0226956', 'cui_str': 'Structure of pharyngeal portion of dorsum of tongue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2675227', 'cui_str': 'Endocrine-Cerebroosteodysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0017673', 'cui_str': 'Glossectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0217685,"The total effective rate in the control group was 41.38% lower than that in the experimental group 67.85%, and the difference was statistically significant （χ²=4.03,  P <0.05）.","[{'ForeName': 'Yongjin', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Yanting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.04.009']
2397,32842229,[Influence of different methods of silicone tube intubation on clinical effects and safety of patients with chronic dacryocystitis].,"Objective: To investigate the influence of conventional STI and endoscopic STI on clinical effects and safety of patients with chronic dacryocystitis.  Method: One hundred and ten patients with chronic dacryocystitis were chosen in the period in our hospital and randomly divided into two groups including conventional group（55 patients） with conventional STI and endoscopy group（55 patients） with endoscopic STI. The improvement rate of epiphora symptoms, ocular surface symptoms score before and after treatment, operation time, intraoperative VAS score and postoperative complication rate of both groups were compared.  Result: There was no significant difference in the improvement rate of epiphora symptoms between two groups（ P >0.05）. The ocular surface symptoms score after treatment of endoscopy group were significantly less than conventional group（ P <0.05）. There was no significant difference in the ocular surface symptoms score after treatment between two groups（ P >0.05）. The operation time and intraoperative VAS score of endoscopy group were significantly less than conventional group（ P <0.05）. The postoperative complication rate of endoscopy group were significantly lower than conventional group（ P <0.05）.  Conclusion: Conventional STI and endoscopic STI in the treatment of patients with chronic dacryocystitis possess the same clinical effects; but endoscopic STI application can efficiently reduce operation difficulty, relieve intraoperative pain and prevent postoperative complications.",2020,There was no significant difference in the improvement rate of epiphora symptoms between two groups（ P >0.05）.,"['One hundred and ten patients with chronic dacryocystitis', 'patients with chronic dacryocystitis']","['conventional group（55 patients） with conventional STI and endoscopy group（55 patients） with endoscopic STI', 'Conventional STI and endoscopic STI', 'conventional STI and endoscopic STI', 'silicone tube intubation']","['improvement rate of epiphora symptoms', 'postoperative complication rate', 'intraoperative pain', 'operation time, intraoperative VAS score and postoperative complication rate', 'improvement rate of epiphora symptoms, ocular surface symptoms score', 'operation time and intraoperative VAS score', 'ocular surface symptoms score']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149506', 'cui_str': 'Chronic dacryocystitis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}]","[{'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",110.0,0.0185832,There was no significant difference in the improvement rate of epiphora symptoms between two groups（ P >0.05）.,"[{'ForeName': 'Deying', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Otolaryngology，Angang General Hospital，Anyang，455004，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.04.013']
2398,32842248,[Intrauterine balloon tamponade combined with temporary abdominal aortic balloon occlusion in the management of women with placenta accreta spectrum:a randomized controlled trial].,"Objective:  To access the effectiveness and safety of the intrauterine balloon tamponade verse gauze packing combined with temporary abdominal aortic balloon occlusion in the management of placenta accreta spectrum (PAS).  Methods:  This was an open-label, randomized controlled trial conducted in Nanjing Drum Tower Hospital. The patients suspected with PAS for uterine preservation surgery under the multidisciplinary team care were recruited between Aug 2015 and Jan 2018. When bleeding could not be achieved after fetus delivered, and a temporary abdominal aortic balloon occlusion and the compression sutures as needed, the women were randomly allocated 1∶1 into balloon tamponade ( n =81) or gauze packing ( n =80) group. The primary outcome was successful bleeding arrests by avoiding second line surgeries. The secondary outcomes included the volume of blood loss during and after cesarean section, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, postpartum pain, ICU admission, need for re-laparotomy, and the length of hospital stay, readmission, and interventional radiology complications.  Results:  All the women [100% (81/81)] in the balloon group were obtained hemostasis without further intervention, significantly higher than 88% (70/80) in the gauze group ( P =0.001). Before uterine tamponade, blood loss were 820 ml (620-1 230) ml and 850 ml (605-1 442) ml, while placenta bed were sutured in 96%（78/81, 77/80） respectively ( P >0.05).The proportion of blood loss≥1 000 ml was higher in the gauze group than that in the balloon group ( P =0.006). Maternal adverse events involving total blood loss, puerperal morbidity and postpartum pain occurred more frequently in the gauze group ( P< 0.05). The following outcome showed no statistically significant difference between the two groups: the vascular occlusion time, the dose of radiation, and interventional radiology complication ( P >0.05). The median volume infused into the lower and upper balloons is 70 ml (50-100 ml) and 180 ml (100-240 ml).  Conclusions:  Incrauterine balloon tamponade is as effective as gauze packing in hemostasis following the placenta delivery in PAS. Compared with gauze packing, the uterine balloon tamponade is more effective.",2020,ml was higher in the gauze group than that in the balloon group ( P =0.006).,"['patients suspected with PAS for uterine preservation surgery under the multidisciplinary team care were recruited between Aug 2015 and Jan 2018', 'Nanjing Drum Tower Hospital', 'women with placenta accreta spectrum']","['balloon tamponade', 'Intrauterine balloon tamponade combined with temporary abdominal aortic balloon occlusion', 'gauze packing', 'intrauterine balloon tamponade verse gauze packing combined with temporary abdominal aortic balloon occlusion', 'Incrauterine balloon tamponade']","['volume of blood loss during and after cesarean section, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, postpartum pain, ICU admission, need for re-laparotomy, and the length of hospital stay, readmission, and interventional radiology complications', 'successful bleeding arrests by avoiding second line surgeries', 'Maternal adverse events involving total blood loss, puerperal morbidity and postpartum pain', 'obtained hemostasis', 'vascular occlusion time, the dose of radiation, and interventional radiology complication', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030125', 'cui_str': 'aminosalicylic acid'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032044', 'cui_str': 'Placenta accreta'}]","[{'cui': 'C2930473', 'cui_str': 'Balloon Tamponade'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0042553', 'cui_str': 'Versed'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0034602', 'cui_str': 'Interventional radiology - specialty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",,0.206593,ml was higher in the gauze group than that in the balloon group ( P =0.006).,"[{'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Dai', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Taizhou People's Hospital of Jiangsu Province, Taizhou 225300, China.""}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Radiology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gu', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Hu', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200225-00135']
2399,32842249,[Effects of double-catheter epidural analgesia by lidocaine injection respectively on the delivery outcomes and maternal-infant complications for persistent posterior or lateral occipital position of protracted active phase].,"Objective:  To evaluate the effect of dual-tube epidural segmental injection of lidocaine analgesia on the delivery outcome and maternal and infant complications of persistent posterior occipital position postpartum or lateral occipital position postpartum patients with protracted active phase.  Methods:  The full and single-term primiparas ( n =216, 37 to 42 weeks gestation, 22 to 35 years) diagnosed as persistent posterior or lateral occipital position during the active period were selected from the Department of Obstetrics of Qingdao Municipal Hospital from January 2015 to October 2019. The subjects were randomly assigned into two groups: double-tube epidural block group ( n =108) and single-tube epidural block group ( n =108), 1% lidocaine was used for epidural analgesia respectively under ultrasound guidance. Senior midwife or obstetricians implement new partogram, and guide women to perform position management, and push or rotate the fetal head in a timely manner. Observation indicators: general condition, the use of non-pharmacological analgesic measures, analgesia related conditions and pain visual analogue scale (VAS) score, delivery-related indicator, cesarean section indication, anesthesia-related indicator, maternal and child complications.  Results:  (1) General condition: the age, weight, height, gestational age, the ratio of persistent lateral or posterior occipital position, cephalic score, and neonatal birth weight between the two groups of women were not statistically significant (all  P >0.05). (2) The use of non-pharmacological analgesic measures: the women's Lamaze breathing method, Doula delivery companionship, percutaneous electrical stimulation, and other measures between two groups were compared, and there were not significant differences (all  P >0.05). (3) Analgesia related conditions and VAS scores of women undergoing vaginal delivery: compared with the single-tube epidural block group ( n =40), the second-partum time of the women in the double-tube epidural block group ( n =59) was significantly shortened [(124±44) vs (86±33) minutes,  P <0.01]; after 30 minutes of analgesia (4.4±0.5 vs 0.9±0.5,  P <0.01), during forced labor in the second stage of labor (5.7±0.6 vs 1.3±0.4,  P <0.01), the VAS scores of pain were also significantly reduced ( P <0.01). (4) Labor-related indicators: compared with the single-tube epidural block group, the natural delivery rate (21.3% vs 49.1%) and the delivery experience satisfaction rate (51.9% vs 98.1%) of women in the double-tube epidural block group were significantly increased (all  P <0.01), cesarean section rate (63.0% vs 45.4%), instrument assisted rate (15.7% vs 5.6%) decreased significantly (all  P <0.05). (5) Cesarean section indications: compared with the single-tube epidural block group, the cesarean section rate caused by prolonged labor or protracted active phase of women in the double-tube epidural block group was significantly reduced (38.0% vs 22.2%；  P <0.05), and the fetal distress, intrauterine infection, and social factors caused by cesarean section between the two groups were compared, while the differences were not statistically significant (all  P >0.05).(6) Anesthesia related indexes: the block planes of the maternal upper tube administration in the double-tube epidural block group were mostly T7, T8, T9-L2 and L3,While,the block planes in the single-tube epidural block group were mostly T10, T11-S1, S2, S3, and the modified Bromage score were all 0. (7) Maternal and child complications: compared with the single-tube epidural block group, the postpartum hemorrhage rate (18.5% vs 7.4%), the perineal lateral cut rate (20.4% vs 5.6%), the neonatal asphyxia rate (12.0% vs 3.7%), ICU rate of transferred neonates (13.9% vs 4.6%) in the double-tube epidural block group were significantly reduced (all  P <0.05). Soft birth canal injury rate, puerperal disease rate and neonatal birth rate between two groups were compared, and there were not statistically significant differences (all  P >0.05).  Conclusion:  Dual-tube epidural segmental injection of lidocaine analgesia could increase the natural delivery rate of women with posterior occipital or lateral occipital position with active stagnation, reduce the rate of cesarean section and the rate of transvaginal instruments, and reduce the complications of mother and child.",2020,"Dual-tube epidural segmental injection of lidocaine analgesia could increase the natural delivery rate of women with posterior occipital or lateral occipital position with active stagnation, reduce the rate of cesarean section and the rate of transvaginal instruments, and reduce the complications of mother and child.","['women undergoing vaginal delivery', 'persistent posterior occipital position postpartum or lateral occipital position postpartum patients with protracted active phase', '37 to 42 weeks gestation, 22 to 35 years) diagnosed as persistent posterior or lateral occipital position during the active period were selected from the Department of Obstetrics of Qingdao Municipal Hospital from January 2015 to October 2019', 'women with posterior occipital or lateral occipital position with active stagnation']","['lidocaine analgesia', 'epidural analgesia respectively under ultrasound guidance', 'double-tube epidural block group', 'double-catheter epidural analgesia', 'lidocaine']","['delivery outcomes and maternal-infant complications', 'natural delivery rate', 'fetal distress, intrauterine infection, and social factors caused by cesarean section', '3) Analgesia related conditions and VAS scores', 'postpartum hemorrhage rate', 'perineal lateral cut rate', 'ratio of persistent lateral or posterior occipital position, cephalic score, and neonatal birth weight', 'ICU rate of transferred neonates', 'cesarean section rate caused by prolonged labor or protracted active phase', 'cesarean section rate', 'rate of cesarean section', 'delivery experience satisfaction rate', 'analgesia related conditions and pain visual analogue scale (VAS) score, delivery-related indicator, cesarean section indication, anesthesia-related indicator, maternal and child complications', 'VAS scores of pain', 'instrument assisted rate', 'Maternal and child complications', 'neonatal asphyxia rate', 'Soft birth canal injury rate, puerperal disease rate and neonatal birth rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0020013', 'cui_str': 'Municipal Hospitals'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C1112157', 'cui_str': 'Intrauterine infection'}, {'cui': 'C0337460', 'cui_str': 'Social factor'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}]",,0.0559332,"Dual-tube epidural segmental injection of lidocaine analgesia could increase the natural delivery rate of women with posterior occipital or lateral occipital position with active stagnation, reduce the rate of cesarean section and the rate of transvaginal instruments, and reduce the complications of mother and child.","[{'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'X Z', 'Initials': 'XZ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Qingdao University, Qingdao 266000, China.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Qingdao University, Qingdao 266000, China.'}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Kang', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'Y Q', 'Initials': 'YQ', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Ji', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20191228-00705']
2400,32842270,[Efficacy and safety of alirocumab versus ezetimibe in high cardiovascular risk Chinese patients with hyperlipidemia: ODYSSEY EAST Study-Chinese sub-population analysis].,"Objective:  To compare the efficacy and safety profile of alirocumab (PCSK9 inhibitor) versus ezetimibe on top of maximally tolerated statin dose in high cardiovascular risk Chinese patients with hyperlipidemia.  Methods:  The ODYSSEY EAST study was a randomized, double-blinded, double dummy, active-control, parallel group, multi-centers clinical trial, the Chinese sub-population included 456 patients with hyperlipidemia and high cardiovascular risk on maximally tolerated statin dose. Patients were randomized (2∶1) to receive the subcutaneous injection of alirocumab (75 mg Q2W; with dose up titration to 150 mg Q2W at week 12 if low-density lipoprotein cholesterol (LDL-C) was ≥1.81 mmol/L at week 8) or the oral administration of ezetimibe (10 mg daily) for 24 weeks. The primary endpoint was percentage change in calculated LDL-C from baseline to week 24. Key secondary efficacy endpoints included percentage change from baseline to week 12 or 24 in LDL-C (week 12) and other lipid parameters, including apolipoprotein (Apo) B, non-high-density lipoprotein cholesterol (non-HDL-C), TC, lipoprotein(a) (Lp(a)), HDL-C, fasting triglycerides (TG), and Apo A1, and the proportion of patients reaching LDL-C<1.81 mmol/L at week 24. Safety profile of therapeutic drugs was also assessed during the treatment period.  Results:  The mean age of 456 Chinese patients was (59.5±10.9) years, 341(74.8%) patients were male, 303 patients (66.4%) in alirocumab group and 153 patients (33.5%) in ezetimibe group. Demographic characteristics, disease characteristics, and lipid parameters at baseline were similar between the two groups. LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both  P <0.001). At 12 weeks, alirocumab had significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-40.3±2.8)%, (-27.7±1.8)%, (-19.6±1.5)% and (-27.7±1.9)%, respectively (all  P <0.001). At 24 weeks, the percent of patients who reached LDL-C<1.81 mmol/L and LDL-C<1.42 mmol/L was significantly higher in alirocumab group (85.3% and 70.5%) than in ezetimibe group (42.2% and 17.0%, both  P <0.001), and alirocumab use was also associated with significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-37.2±2.8)%, (-29.1±2.0)%, (-21.6±1.6)% and (-29.6±2.2)%, respectively (all  P <0.001). The incidence of treatment related adverse events was similar between the two treatment groups (223/302 patients (73.8%) in alirocumab group and 109/153 patients (71.2%) in ezetimibe group). Respiratory infection, urinary infection, dizziness and local injection-site reactions were the most frequently reported adverse events.  Conclusions:  In high cardiovascular risk patients with hyperlipidemia from China on maximally tolerated statin dose, the reduction of LDL-C induced by alirocumab is more significant than that induced by ezetimibe. Both treatments were generally safe during the observation period of study.",2020,"LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both  P <0.001).","['high cardiovascular risk Chinese patients with hyperlipidemia', 'patients were male, 303 patients (66.4%) in alirocumab group and 153 patients (33.5%) in ezetimibe group', '456 patients with hyperlipidemia and high cardiovascular risk on maximally tolerated statin dose', 'The mean age of 456 Chinese patients was (59.5±10.9) years, 341(74.8']","['ezetimibe', 'subcutaneous injection of alirocumab', 'alirocumab versus ezetimibe', 'alirocumab', 'alirocumab (PCSK9 inhibitor']","['LDL-C (week 12) and other lipid parameters, including apolipoprotein (Apo) B, non-high-density lipoprotein cholesterol (non-HDL-C), TC, lipoprotein(a) (Lp(a)), HDL-C, fasting triglycerides (TG), and Apo A1, and the proportion of patients reaching LDL', 'adverse events', 'Respiratory infection, urinary infection, dizziness and local injection-site reactions', 'percentage change in calculated LDL-C', 'LDL-C', 'Lp(a), Apo B, total cholesterol and non HDL-C', 'Demographic characteristics, disease characteristics, and lipid parameters']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4521460', 'cui_str': 'PCSK9 inhibitor'}]","[{'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",456.0,0.167077,"LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both  P <0.001).","[{'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern War Zone, Shenyang 110016, China.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, General Hospital of Northern War Zone, Shenyang 110016, China.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Jinan Central Hospital Affiliated to Shandong University, Jinan 250000, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern War Zone, Shenyang 110016, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Medical, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Liu', 'Affiliation': 'R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}]",Zhonghua xin xue guan bing za zhi,['10.3760/cma.j.cn112148-20191216-00755']
2401,32842315,[Safety and immunogenicity analysis of recombinant （hansenula polymorpha) hepatitis B vaccine （CpG ODN adjuvant) among adults: the preliminary results of phase I clinical trial].,"Objective:  To evaluate the safety and immune effect of recombinant hepatitis B vaccine （CpG ODN adjuvant).  Methods:  On Oct. 26, 2016, we launched volunteer recruitment in Kaihua county, Quzhou city, Zhejiang Province. In the randomized, double-blind, controlled trial, a total of 48 subjects with negative HBV screening tests and normal hepatorenal function among 18 and 60 years old were selected and divided into two groups randomly, 24 cases each. The experimental group was given 250 μg of CpG ODN recombinant （Hansenula polymorpha) Hepatitis B vaccine and the control group was given 10 μg of commercial Hepatitis B vaccine with timed at 0, 1and 6 months. The inoculation reactions were compared the difference between the two groups after observed and recorded in time periods. We also collected serum before and after immunization to compare the two groups of anti-HBs positive rate, geometric mean concentration（GMC).  Results:  During the study period, the incidence of adverse events was 66.67%（16/24) in the experimental group and 54.17%（13/24) in the control group, with no significant difference（ P =0.556). The severities of adverse events were level 1 or level 2, and no level 3 or above adverse reactions occurred. After full-course immunization, in the FAS data set, the anti-HBs GMC in the experimental group [2 598.56（1 127.90-5 986.90) mIU/ml] was higher than that in the control group[371.97（164.54-840.91) mIU/ml] In the PPS set, the GMC of test group was 7 808.21（3 377.00-18 052.00) mIU/ml, which was higher than that of the control group [843.22（213.80-3 325.90) mIU/ml]. The anti-HBs positive rate of FAS（PPS) was 95.83%（100.00%) in the experimental group and the control group; The anti-HBs strongly positive rate of FAS（PPS) was 79.17%（90.00%) in the experimental group and 33.33%（50.00%) in the control group, with statistically significant differences among the FAS set（ P =0.003) and no statistically significance differences among the PPS set（ P =0.074).  Conclusion:  CpG Hepatitis B Vaccine is safe and shows better immunogenicity than the control vaccine.",2020,"During the study period, the incidence of adverse events was 66.67%（16/24) in the experimental group and 54.17%（13/24) in the control group, with no significant difference（ P =0.556).","['48 subjects with negative HBV screening tests and normal hepatorenal function among 18 and 60 years old', 'adults', 'On Oct. 26, 2016, we launched volunteer recruitment in Kaihua county, Quzhou city, Zhejiang Province']","['recombinant hepatitis B vaccine （CpG ODN adjuvant', 'mIU/ml', 'recombinant （hansenula polymorpha) hepatitis B vaccine （CpG ODN adjuvant']","['anti-HBs positive rate of FAS（PPS', 'severities of adverse events', 'inoculation reactions', 'incidence of adverse events', 'anti-HBs strongly positive rate of FAS（PPS']","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0914671', 'cui_str': 'CPG-ODN'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0319605', 'cui_str': 'Pichia angusta'}]","[{'cui': 'C0149708', 'cui_str': 'Hepatitis B surface antibody positive'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",48.0,0.0592319,"During the study period, the incidence of adverse events was 66.67%（16/24) in the experimental group and 54.17%（13/24) in the control group, with no significant difference（ P =0.556).","[{'ForeName': 'Z Z', 'Initials': 'ZZ', 'LastName': 'Liang', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Changchun Huapu Bio-Tech Co., Ltd, Changchun 130103, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Yan', 'Affiliation': 'Kaihua Center of Disease Control and Prevention, Quzhou 324300, Zhejiang Province, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Kaihua Center of Disease Control and Prevention, Quzhou 324300, Zhejiang Province, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Changchun Huapu Bio-Tech Co., Ltd, Changchun 130103, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'X S', 'Initials': 'XS', 'LastName': 'Hu', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Lyu', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}]",Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine],['10.3760/cma.j.cn112150-20200401-00490']
2402,32842336,[Comparative analysis of the clinical application of two femtosecond laser-assisted cataract operation platforms].,"Objective:  To evaluate the operability and clinical application effects of femtosecond laser-assisted cataract surgery systems of LenSx and LenSAR.  Methods:  This was a randomized controlled study. A total of 86 patients (90 eyes) who underwent femtosecond laser-assisted cataract surgery in Wuhan Aier Eye Hospital from April 2018 to November 2018 were enrolled and divided into two groups randomly, including 44 patients (45 eyes) in the LenSx group and 42 patients (45 eyes) in the LenSAR group. During the operation, the following observation indexes were obtained. Operational indicators included the number of docking attempts, anterior capsulotomy time, nucleus pre-treatment time, total femtosecond laser emission time, and total vacuum suction duration. Clinical outcome indicators included changes in the patient's intraocular pressure during femtosecond laser surgery, the rate of subconjunctival hemorrhage, capsulotomy integrity (yes/no), roundness and centricity of the anterior capsule opening (yes/no), the rate of anterior capsule opening tear, and the rate of posterior capsule rupture. The  t -test, rank-sum test or chi-square test were used for statistical analysis.  Results:  There were no significant differences between groups in the age and the lens density (both  P >0.05). The number of docking attempts in the LenSx group was 1 (1 to 4) and in the LenSAR group was 1 (1 to 2); there was statistically significant difference ( Z  =-2.23,  P <0.05). The difference in the anterior capsulotomy time between the two groups was statistically significant [13.00 (10.00 to 22.00) s compared with 3.00 (1.00 to 3.00) s,  Z =-8.71,  P <0.05]. The femtosecond laser pre-nucleation time and total femtosecond laser emission time of the LenSx group were (16.67±3.36) s and (30.49±3.53) s, and those of the LenSAR group were (12.38±4.36) s and (15.36±4.29) s, respectively; the differences between the two groups were statistically significant ( t =-5.23, -18.26; both  P <0.05). The total vacuum suction duration in the LenSx group was (97.23±19.96) s, shorter than that in the LenSAR group [(123.76±16.81) s] ( t =6.82,  P <0.05). The intraocular pressure after femtosecond laser surgery in both groups was higher than that before surgery. The increase of intraocular pressure in the LenSAR group was (5.64±5.42) mmHg (1 mmHg=0.133 kPa), higher than that in the LenSx group [(2.99±4.66) mmHg] ( t =-2.49,  P <0.05). The rate of subconjunctival hemorrhage in the LenSx group was 33.3% (15/45), while it was 8.9% (4/45) in the LenSAR group; the difference between the two groups was statistically significant (χ²=6.67,  P <0.05). There were no significant differences between groups in capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture (all  P >0.05).  Conclusion:  The docking process of the LenSAR system is convenient, and there is less subconjunctival hemorrhage; the total vacuum suction duration of LenSx is short, and the increase of intraocular pressure is low.  (Chin J Ophthalmol, 2020, 56: 530-535) .",2020,"There were no significant differences between groups in capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture (all  P >0.05).  ","['in Wuhan Aier Eye Hospital from April 2018 to November 2018 were enrolled and divided into two groups randomly, including 44 patients (45 eyes) in the LenSx group and 42 patients (45 eyes) in the LenSAR group', '86 patients (90 eyes) who underwent']","['femtosecond laser surgery', 'femtosecond laser-assisted cataract operation platforms', 'femtosecond laser-assisted cataract surgery', 'femtosecond laser-assisted cataract surgery systems']","['number of docking attempts', 'femtosecond laser pre-nucleation time and total femtosecond laser emission time', 'capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture', 'total vacuum suction duration', ""patient's intraocular pressure during femtosecond laser surgery, the rate of subconjunctival hemorrhage, capsulotomy integrity (yes/no), roundness and centricity of the anterior capsule opening (yes/no), the rate of anterior capsule opening tear, and the rate of posterior capsule rupture"", 'anterior capsulotomy time', 'lens density', 'rate of subconjunctival hemorrhage', 'intraocular pressure', 'number of docking attempts, anterior capsulotomy time, nucleus pre-treatment time, total femtosecond laser emission time, and total vacuum suction duration']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1504458', 'cui_str': 'Cataract operation'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442632', 'cui_str': 'Dock - marine'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1535895', 'cui_str': 'Posterior capsule rupture'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",86.0,0.0284372,"There were no significant differences between groups in capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture (all  P >0.05).  ","[{'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Xu', 'Affiliation': 'Aier School of Ophthalmology, Central South University, Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Bao', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lei', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Li', 'Affiliation': 'Aier School of Ophthalmology, Central South University, Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'X T', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Aier School of Ophthalmology, Central South University, Wuhan Aier Eye Hospital, Wuhan 430061, China.'}]",[Zhonghua yan ke za zhi] Chinese journal of ophthalmology,['10.3760/cma.j.cn112142-20191113-00571']
2403,32842583,Benefit of Wearing an Activity Tracker in Sarcoidosis.,"Sarcoidosis causes many disabling symptoms, including fatigue and exercise limitations, which have been shown to improve by physical activity programs. The aim of this study was to estimate the effect of continuous activity monitoring using an electronic activity tracker (AT) on exercise performance and fatigue of sarcoidosis patients, compared to controls (cohort study), and the effect of additional personal coaching (randomized trial) over a period of 3 months. Fifty-four sarcoidosis patients received an AT (Group Ia: 27 with coaching and Group Ib: 27 without). A historical group of sarcoidosis patients (Group II;  n  = 41) who did not follow a physical activity program served as controls. Exercise performance of patients wearing an AT (Group I) improved compared with controls (Group II), including the 6MWD, % predicted (∆4.4 ± 9.1 versus ∆0.7 ± 5.0, respectively), and fatigue levels decreased (∆-3.9 ± 5.7 versus ∆-1.8 ± 5.3). Patients with coaching (Group Ia) showed greater improvement of exercise capacity over time than patients without coaching (Group Ib) as shown by the Steep Ramp Test results (watts: ∆20.2 ± 33.8 versus ∆5.7 ± 26.4; and SRT, VO 2 max, % predicted: ∆1.6 ± 2.6 versus ∆0.7 ± 2.3). Sarcoidosis patients wearing an AT achieved improvement of exercise performance and reduction of fatigue. We therefore recommend encouraging sarcoidosis patients to wear an AT to stimulate physical activity and reduce fatigue. The additional benefit of coaching needs to be explored in future studies.",2020,"Exercise performance of patients wearing an AT (Group I) improved compared with controls (Group II), including the 6MWD, % predicted (∆4.4 ± 9.1 versus ∆0.7 ± 5.0, respectively), and fatigue levels decreased (∆-3.9 ± 5.7 versus ∆-1.8 ± 5.3).",[],"['continuous activity monitoring using an electronic activity tracker (AT', 'AT', 'sarcoidosis patients (Group II;  n  = 41) who did not follow a physical activity program served as controls', 'additional personal coaching']","['exercise performance and reduction of fatigue', 'fatigue levels', 'exercise capacity', 'Exercise performance']",[],"[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}]",54.0,0.039776,"Exercise performance of patients wearing an AT (Group I) improved compared with controls (Group II), including the 6MWD, % predicted (∆4.4 ± 9.1 versus ∆0.7 ± 5.0, respectively), and fatigue levels decreased (∆-3.9 ± 5.7 versus ∆-1.8 ± 5.3).","[{'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Drent', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'Elfferich', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Breedveld', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Jolanda De', 'Initials': 'J', 'LastName': 'Vries', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Strookappe', 'Affiliation': 'ILD Care Foundation Research Team, 6711 NR Ede, The Netherlands.'}]",Journal of personalized medicine,['10.3390/jpm10030097']
2404,32842644,Effects of Pyramid Resistance-Training System with Different Repetition Zones on Cardiovascular Risk Factors in Older Women: A Randomized Controlled Trial.,"This study analyzed the effects of the pyramidal resistance training (RT) system with two repetition zones on cardiovascular risk factors in older women (≥60 years old). Fifty-nine older women were randomly assigned in three groups: non-exercise control (CON,  n  = 19), narrow-pyramid system (NPR,  n  = 20), and wide-pyramid system (WPR,  n  = 20). Training was performed for eight weeks (eight exercises for the whole-body, 3x/week) in which NPR and WPR performed three sets of 12/10/8 and 15/10/5 repetitions, respectively. Regional body fat was estimated by dual-energy X-ray absorptiometry, and blood parameters related to glycemic, lipid, and inflammatory profiles were assessed. After the training period, although no difference was observed for the magnitude of the changes between NPR and WPR, significant group by time interactions indicated benefits with RT compared to CON for reducing body fat (mainly android body fat; -7%) and improving glucose, HDL-C, LDL-C and C-reactive protein ( p  < 0.05). Composite z-score of cardiovascular risk, created by the average of the intervention effects on the outcomes, indicate similar responses between NPR and WPR, differing from CON ( p  < 0.001). Results indicate that both the repetition zones of the pyramidal RT reduced similarly the cardiovascular risk in older women.",2020,"After the training period, although no difference was observed for the magnitude of the changes between NPR and WPR, significant group by time interactions indicated benefits with RT compared to CON for reducing body fat (mainly android body fat; -7%) and improving glucose, HDL-C, LDL-C and C-reactive protein ( p  < 0.05).","['older women', 'Older Women', 'Fifty-nine older women', 'older women (≥60 years old']","['pyramidal resistance training (RT) system with two repetition zones', 'CON', 'non-exercise control (CON,  n  = 19), narrow-pyramid system (NPR,  n  = 20), and wide-pyramid system', 'Pyramid Resistance-Training System with Different Repetition Zones']","['cardiovascular risk factors', 'Cardiovascular Risk Factors', 'body fat', 'Composite z-score of cardiovascular risk', 'improving glucose, HDL-C, LDL-C and C-reactive protein', 'Regional body fat', 'cardiovascular risk']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",59.0,0.0213912,"After the training period, although no difference was observed for the magnitude of the changes between NPR and WPR, significant group by time interactions indicated benefits with RT compared to CON for reducing body fat (mainly android body fat; -7%) and improving glucose, HDL-C, LDL-C and C-reactive protein ( p  < 0.05).","[{'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Dos Santos', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Hellen C G', 'Initials': 'HCG', 'LastName': 'Nabuco', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sugihara Junior', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Rodrigo R', 'Initials': 'RR', 'LastName': 'Fernandes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Campa', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, 47921 Rimini, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, 1499-002 Lisboa, Portugal.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176115']
2405,32842705,Increased First Pass Success with C-MAC Videolaryngoscopy in Prehospital Endotracheal Intubation-A Randomized Controlled Trial.,"Endotracheal intubation (ETI) with direct view laryngoscopy (DL) is the gold standard for airway management. Videolaryngoscopy (VL) can improve glottis visualization, thus facilitating ETI. The aim of this monocentric, randomized, prospective study on a physician staffed German air ambulance is to compare DL and VL for ETI in terms of number of attempts and time as well as visualization of the glottis in a prehospital setting in a physician-based rescue system in adult patients. A power analysis was performed à priori. We used consecutive on-scene randomization with a sealed envelope system for the DL and VL-group. Successful ETI with first pass success was significantly more frequent with VL than DL and three seconds faster. The percentage of glottis opening and the Cormack & Lehane classification were significantly better with VL than DL. Regarding improved first pass success in ETI with the VL, we would recommend the use of VL for prehospital airway management in physician-based rescue systems.",2020,The percentage of glottis opening and the Cormack & Lehane classification were significantly better with VL than DL.,['adult patients'],"['Endotracheal intubation (ETI) with direct view laryngoscopy (DL', 'Videolaryngoscopy (VL']",['percentage of glottis opening and the Cormack & Lehane classification'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",,0.040486,The percentage of glottis opening and the Cormack & Lehane classification were significantly better with VL than DL.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Macke', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Gralla', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Winkelmann', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Jan-Dierk', 'Initials': 'JD', 'LastName': 'Clausen', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Haertle', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krettek', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Trauma Department, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hanover, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9092719']
2406,32842812,Asymmetric dimethylarginine predicts perioperative cardiovascular complications in patients undergoing medium-to-high risk non-cardiac surgery.,"OBJECTIVES


Perioperative cardiovascular events remain an important factor that affects surgery outcome. We assessed if asymmetric dimethylarginine (ADMA), an endogenous inhibitor of nitric oxide synthesis, predicts perioperative risk, and if pre-operative supplementation with L-arginine/L-citrulline improves the plasma L-arginine/ADMA ratio.
METHODS


In this prospective study, planned thoracic and/or abdominal surgery patients were randomized to receive L-arginine/L-citrulline (5 g/day) or placebo 1 to 5 days before surgery. We measured perioperative plasma ADMA and L-arginine levels. The primary outcome was a 30-day combined cardiovascular endpoint.
RESULTS


Among 269 patients, 23 (8.6%) experienced a major adverse cardiovascular event. ADMA and C-reactive protein were significantly associated with the incidence of cardiovascular complications in the multivariable-adjusted analysis. The L-arginine plasma concentration was significantly higher on the day of surgery with L-arginine/L-citrulline supplementation compared with placebo. In patients with high pre-operative ADMA, there was a non-significant trend towards reduced incidence of the primary endpoint with L-arginine/L-citrulline supplementation (six vs. nine events).
CONCLUSIONS


ADMA is a predictor of major adverse cardiovascular complications in the perioperative period for patients who are undergoing major abdominal and/or thoracic surgery. Supplementation with L-arginine/L-citrulline increased the L-arginine plasma concentration, enhanced the L-arginine/ADMA ratio, and induced a trend towards fewer perioperative events.",2020,The L-arginine plasma concentration was significantly higher on the day of surgery with L-arginine/L-citrulline supplementation compared with placebo.,"['patients who are undergoing major abdominal and/or thoracic surgery', 'patients undergoing medium-to-high risk non-cardiac surgery', 'planned thoracic and/or abdominal surgery patients']","['placebo', 'Asymmetric dimethylarginine', 'L-arginine/L-citrulline']","['perioperative plasma ADMA and L-arginine levels', 'asymmetric dimethylarginine (ADMA', 'L-arginine plasma concentration', 'L-arginine/L-citrulline supplementation', 'ADMA and C-reactive protein', 'plasma L-arginine/ADMA ratio', 'cardiovascular complications', 'major adverse cardiovascular event', '30-day combined cardiovascular endpoint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",269.0,0.354141,The L-arginine plasma concentration was significantly higher on the day of surgery with L-arginine/L-citrulline supplementation compared with placebo.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Appel', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Anesthesiology, Hamburg, DE, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Böger', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, Hamburg, DE, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Windolph', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, Hamburg, DE, Germany.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Heinze', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Anesthesiology, Hamburg, DE, Germany.'}, {'ForeName': 'Alwin E', 'Initials': 'AE', 'LastName': 'Goetz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Anesthesiology, Hamburg, DE, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hannemann', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, Hamburg, DE, Germany.'}]",The Journal of international medical research,['10.1177/0300060520940450']
2407,32842825,A low dose of lysergic acid diethylamide decreases pain perception in healthy volunteers.,"BACKGROUND


Lysergic acid diethylamide (LSD) is an ergot alkaloid derivative with psychedelic properties that has been implicated in the management of persistent pain. Clinical studies in the 1960s and 1970s have demonstrated profound analgesic effects of full doses of LSD in terminally ill patients, but this line of research evaporated after LSD was scheduled worldwide.
AIM


The present clinical study is the first to revisit the potential of LSD as an analgesic, and at dose levels which are not expected to produce profound mind-altering effects.
METHODS


Twenty-four healthy volunteers received single doses of 5, 10 and 20 µg LSD as well as placebo on separate occasions. A Cold Pressor Test was administered at 1.5 and 5 h after treatment administration to assess pain tolerance to experimentally evoked pain. Ratings of dissociation and psychiatric symptoms as well as assessments of vital signs were included to monitor mental status as well as safety during treatments.
RESULTS


LSD 20 µg significantly increased the time that participants were able to tolerate exposure to cold (3°C) water and decreased their subjective levels of experienced pain and unpleasantness. LSD elevated mean blood pressure within the normal range and slightly increased ratings of dissociation, anxiety and somatization.
CONCLUSION


The present study provides evidence of a protracted analgesic effect of LSD at a dose that is low enough to avoid a psychedelic experience. The present data warrant further research into the analgesic effects of low doses of LSD in patient populations.",2020,"RESULTS


LSD 20 µg significantly increased the time that participants were able to tolerate exposure to cold (3°C) water and decreased their subjective levels of experienced pain and unpleasantness.","['healthy volunteers', 'Twenty-four healthy volunteers']","['Lysergic acid diethylamide (LSD', 'placebo', 'LSD', 'lysergic acid diethylamide']","['Ratings of dissociation and psychiatric symptoms', 'subjective levels of experienced pain and unpleasantness', 'pain tolerance', 'ratings of dissociation, anxiety and somatization', 'LSD elevated mean blood pressure', 'pain perception']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",24.0,0.113171,"RESULTS


LSD 20 µg significantly increased the time that participants were able to tolerate exposure to cold (3°C) water and decreased their subjective levels of experienced pain and unpleasantness.","[{'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dolder', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, UK.'}, {'ForeName': 'Kim Pc', 'Initials': 'KP', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120940937']
2408,32842836,Hypertension and orthostatic hypotension with venlafaxine treatment in depressed older adults.,"BACKGROUND


Venlafaxine, a serotonin-norepinephrine reuptake inhibitor, is often used as first- or second-line therapy for depression in older adults. It can be associated with adverse blood pressure (BP) effects.
METHODS


Adults ⩾60 years of age in a current major depressive episode were treated in a protocolized manner with venlafaxine XR; 429 participants were treated for 8-16 weeks with a daily dose up to 300 mg to achieve remission from depression. Cardiac measures included sitting and standing BP and heart rate.
RESULTS


Of participants who were normotensive at baseline, 6.5% were found to have elevated BP during the study (1.9% <225 mg/day; 9.8% ⩾225 mg/day). There was no significant change in mean BP in the overall sample, or in the subgroup treated with doses ⩾225 mg/day. Additionally, 20.1% of the participants who did not have orthostatic hypotension at baseline were found to have orthostatic hypotension (16.8% <225 mg/day; 22.4% ⩾225 mg/day). Participants with new-onset orthostatic hypotension were significantly more likely to fall than the other participants.
CONCLUSION


A large proportion of older adults treated with venlafaxine experience orthostatic hypotension, putting them at risk for falls. A smaller proportion experience elevated BP. Older patients prescribed venlafaxine, particularly at high doses, should be advised and counseled about these adverse effects.",2020,"There was no significant change in mean BP in the overall sample, or in the subgroup treated with doses ⩾225 mg/day.","['older adults', 'Older patients prescribed', 'Adults ⩾60 years of age in a current major depressive episode were treated in a protocolized manner with', 'depressed older adults', '429 participants']","['Venlafaxine', 'venlafaxine XR', 'venlafaxine']","['mean BP', 'elevated BP', 'Hypertension and orthostatic hypotension', 'sitting and standing BP and heart rate', 'orthostatic hypotension', 'new-onset orthostatic hypotension', 'adverse blood pressure (BP) effects']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",429.0,0.0371764,"There was no significant change in mean BP in the overall sample, or in the subgroup treated with doses ⩾225 mg/day.","[{'ForeName': 'Rafae', 'Initials': 'R', 'LastName': 'Wathra', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Kyle W', 'Initials': 'KW', 'LastName': 'Goldberger', 'Affiliation': ""Department of Neurology, Faculty of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Washington University School of Medicine, Saint Louis, USA.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, USA.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sanches', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto, Canada.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120944154']
2409,32842839,Parental ADHD Knowledge in Latinx Families: Gender Differences and Treatment Effects.,"OBJECTIVE


The current study aimed to extend findings of a study comparing two psychosocial treatments for ADHD in Latinx youth by examining if parental ADHD knowledge improves following treatment and if parental gender differences in ADHD knowledge exist.
METHOD


Following a comprehensive ADHD assessment, 58 Latinx families of school-aged children (mean age of 8 years) were randomly assigned to either culturally-adapted treatment (CAT) or standard evidence-based treatment (EBT). Parents completed an ADHD Knowledge measure both pre- and post-treatment.
RESULTS/CONCLUSION


Latinx mothers demonstrated greater knowledge of ADHD symptomatology than fathers at pre-treatment. CAT resulted in improvements in parental knowledge of ADHD for both mothers and fathers, whereas standard EBT resulted in no change in maternal knowledge and reduced paternal knowledge of ADHD symptomatology. Clinical implications will be discussed.",2020,"CAT resulted in improvements in parental knowledge of ADHD for both mothers and fathers, whereas standard EBT resulted in no change in maternal knowledge and reduced paternal knowledge of ADHD symptomatology.","['Latinx Families', '58 Latinx families of school-aged children (mean age of 8\u2009years']","['culturally-adapted treatment (CAT) or standard evidence-based treatment (EBT', 'CAT']","['knowledge of ADHD symptomatology', 'maternal knowledge and reduced paternal knowledge of ADHD symptomatology', 'parental knowledge of ADHD']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0337493', 'cui_str': 'Paternal'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.0308701,"CAT resulted in improvements in parental knowledge of ADHD for both mothers and fathers, whereas standard EBT resulted in no change in maternal knowledge and reduced paternal knowledge of ADHD symptomatology.","[{'ForeName': 'Alyson C', 'Initials': 'AC', 'LastName': 'Gerdes', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Malkoff', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Kapke', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grace', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}]",Journal of attention disorders,['10.1177/1087054720951853']
2410,32842931,Help or flight? Increased threat imminence promotes defensive helping in humans.,"In humans and other mammals, defensive responses to danger vary with threat imminence, but it is unknown how those responses affect decisions to help conspecifics. Here, we manipulated threat imminence to investigate the impact of different defensive states on human helping behaviour. Ninety-eight healthy adult participants made trial-by-trial decisions about whether to help a co-participant avoid an aversive shock, at the risk of receiving a shock themselves. Helping decisions were prompted under imminent or distal threat, based on temporal distance to the moment of shock administration to the co-participant. Results showed that, regardless of how likely participants were to also receive a shock, they helped the co-participant more under imminent than distal threat. Reaction times and cardiac changes during the task supported the efficacy of the threat imminence manipulation in eliciting dissociable defensive states, with faster responses and increased heart rate during imminent compared to distal threats. Individual differences in empathic concern were specifically correlated with helping during imminent threats. These results suggest that defensive states driving active escape from immediate danger may also facilitate decisions to help others, potentially by engaging neurocognitive systems implicated in caregiving across mammals.",2020,"Reaction times and cardiac changes during the task supported the efficacy of the threat imminence manipulation in eliciting dissociable defensive states, with faster responses and increased heart rate during imminent compared to distal threats.",['Ninety-eight healthy adult participants'],[],"['Reaction times and cardiac changes', 'heart rate']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",98.0,0.0544391,"Reaction times and cardiac changes during the task supported the efficacy of the threat imminence manipulation in eliciting dissociable defensive states, with faster responses and increased heart rate during imminent compared to distal threats.","[{'ForeName': 'Joana B', 'Initials': 'JB', 'LastName': 'Vieira', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schellhaas', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Enström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Olsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}]",Proceedings. Biological sciences,['10.1098/rspb.2020.1473']
2411,32843793,Effects of Single Dose of Dexamethasone on Perioperative Blood Glucose Levels in Patients Undergoing Surgery for Supratentorial Tumors - An Observational Study.,"Introduction


Dexamethasone is commonly administered in intracranial tumors to reduce the cerebral edema. Its administration may be associated with hyperglycemia. The primary objective of this study was to study the magnitude of rise in blood sugar levels following the administration of a single 10 mg dose of dexamethasone.
Methods


Seventy patients who underwent various neurosurgical procedures were enrolled in the study. Group D ( n  = 35 undergoing surgery for intracranial tumors) were administered injection dexamethasone 10 mg while as Group  P  ( n  = 35 undergoing surgery for subarachnoid hemorrhage) received placebo. Blood samples were obtained through the arterial line at baseline (before dexamethasone administration), 60, 120, 180, and 240 min after the dexamethasone administration and blood glucose concentrations noted.
Results


Glucose concentrations were significantly increased in patients who received dexamethasone compared with those who received placebo ( P  < 0.05). Blood glucose concentrations at different time intervals were greater when compared with the baseline blood sugar levels in both the placebo and dexamethasone group ( P  < 0.05). The arterial blood glucose concentration in those who received 10 mg dexamethasone ( n  = 35) increased from 95.29 ± 13.69 mg.dl -1  to 139.97 ± 10.34 mg.dl -1  over 4 h, compared with a change from 94.74 ± 10.05 mg.dl -1  to 122.34 ± 10.68 mg.dl -1  in those who received placebo ( n  = 35) ( P  < 0.05).
Conclusion


The administration of a single intravenous dose of 10-mg dose dexamethasone caused a significant increase in the blood glucose concentrations at different point intervals when compared with the placebo over a 4-h period. We recommend intensive monitoring of the blood sugar levels during the intraoperative period to prevent the development of severe hyperglycemia and its associated complications.",2020,"Results


Glucose concentrations were significantly increased in patients who received dexamethasone compared with those who received placebo ( P  < 0.05).","['Patients Undergoing Surgery for Supratentorial Tumors ', 'Seventy patients who underwent various neurosurgical procedures were enrolled in the study', '35 undergoing surgery for intracranial tumors']","['dexamethasone', 'Dexamethasone', 'placebo', 'injection dexamethasone']","['Perioperative Blood Glucose Levels', 'arterial blood glucose concentration', 'baseline blood sugar levels', 'Blood glucose concentrations', 'blood sugar levels', 'Results\n\n\nGlucose concentrations', 'cerebral edema', 'blood glucose concentrations', 'blood glucose concentrations noted']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038874', 'cui_str': 'Neoplasms, Supratentorial'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0524850', 'cui_str': 'Operation on nervous system'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1527390', 'cui_str': 'Intracranial tumor'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}]",70.0,0.381561,"Results


Glucose concentrations were significantly increased in patients who received dexamethasone compared with those who received placebo ( P  < 0.05).","[{'ForeName': 'Zulfiqar', 'Initials': 'Z', 'LastName': 'Ali', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Mohammad Akbar', 'Initials': 'MA', 'LastName': 'Shah', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Shahid Ahmad', 'Initials': 'SA', 'LastName': 'Mir', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Nelofar', 'Initials': 'N', 'LastName': 'Hassan', 'Affiliation': 'Department of General Medicine, Government Gousia Hospital, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Shariq Rashid', 'Initials': 'SR', 'LastName': 'Masoodi', 'Affiliation': 'Department of Endocrinology, Sheri Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_21_20']
2412,32843792,"Sternomental Distance Ratio as a Predictor of Difficult Laryngoscopy: A Prospective, Double-Blind Pilot Study.","Background


No single test has shown to be an accurate predictor of difficult laryngoscopy.
Aims


This study aims to evaluate the effectiveness of the ratio of the sternomental distance (SMD) in neutral and full neck extension position SMD ratio (SMDR) as a predictor of difficult laryngoscopy and any need of assisted intubation.
Settings and Design


Prospective, double-blind pilot study.
Materials and Methods


This study included 221 consecutive adult patients scheduled to undergo elective surgery under general anesthesia. Physical and airway characteristics, SMDR, difficult laryngoscopy (using Cormack/Lehane [C/L] scale), and any kind of assisted intubation were assessed.
Statistical Analysis


The optimal cutoff point for SMDR was identified using receiver operating characteristic (ROC) analysis. The association between SMDR and the intubation method was evaluated through multiple logistic regression analysis.
Results


A SMDR below 1.55 led in 33% of the cases to assisted intubation and 33%-53% of C/L III-IV glottic views for McCoy and Macintosh blades, respectively. On the other hand, SMDR above 1.9 led to no C/L IV glottic views for both blades and 4% and 11% C/L III views glottic views for McCoy and Macintosh, respectively. The best sensitivity and specificity cutoff point as defined by the ROC curve was identified for an SMDR value of 1.7 (area[s] under the curve: 0.815; 95% confidence interval: 0.743-0.887). Assisted intubation rates were significantly higher in patients with an SMDR inferior to 1.7 (30.5% compared to 3.5%,  P  < 0.001).
Conclusions


SMDR is a simple, objective, and easy to perform test. The present study indicates that SMDR may be helpful in predicting difficult laryngoscopy and assisted intubation.",2020,"Assisted intubation rates were significantly higher in patients with an SMDR inferior to 1.7 (30.5% compared to 3.5%,  P  < 0.001).
",['221 consecutive adult patients scheduled to undergo elective surgery under general anesthesia'],[],"['sternomental distance (SMD) in neutral and full neck extension position SMD ratio (SMDR', 'Assisted intubation rates', 'Physical and airway characteristics, SMDR, difficult laryngoscopy (using Cormack/Lehane [C/L] scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]",[],"[{'cui': 'C1959922', 'cui_str': 'Sternomental distance'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4759767', 'cui_str': 'Spondylometaphyseal dysplasia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",221.0,0.197686,"Assisted intubation rates were significantly higher in patients with an SMDR inferior to 1.7 (30.5% compared to 3.5%,  P  < 0.001).
","[{'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Kopanaki', 'Affiliation': 'Department of Anesthesiology, Thriasio General Hospital of Elefsina, Magoula-Elefsina, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Piagkou', 'Affiliation': 'Department of Anatomy, Medical School, National and Kapodistrian University of Athens, Zografou, Athens, Greece.'}, {'ForeName': 'Theano', 'Initials': 'T', 'LastName': 'Demesticha', 'Affiliation': 'Department of Anatomy, Medical School, National and Kapodistrian University of Athens, Zografou, Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Anastassiou', 'Affiliation': 'Department of Anesthesiology, Thriasio General Hospital of Elefsina, Magoula-Elefsina, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Skandalakis', 'Affiliation': 'Department of Anatomy, Medical School, National and Kapodistrian University of Athens, Zografou, Athens, Greece.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_2_20']
2413,32843794,Etomidate versus Propofol for Motor Seizure Duration during Modified Electroconvulsive Therapy.,"Background


Certain anesthetic agents on account of their anticonvulsant property have a negative impact on motor seizure duration. Etomidate and propofol being devoid of the strong anticonvulsant property may be beneficial for use in electroconvulsive therapy (ECT). ECT requires sedation with a short-term anesthetic agent that does not interfere with seizure activity and has rapid onset and recovery to facilitate fast-tracking.
Aims


The primary objective of this study was to compare motor seizure duration, and the secondary objective was to compare induction time, hemodynamic parameters, recovery time, and adverse effects between propofol and etomidate in modified ECT.
Settings and Design


This is a prospective, double- blind, randomized, controlled study conducted in the Department of Anesthesia and Intensive care in a tertiary care hospital during 2018-2019.
Materials and Methods


After ethical clearance from institutional ethics committee and written informed consent, a total of 70 patients, aged 18-65 years were randomly allocated using computer generated random number list into two groups - Group A - Propofol (1%) - 1.0 mg.kg -1  and Group B - Etomidate 0.2 mg.kg -1  as an intravenous induction agent. Intraoperatively, motor seizure duration, induction time, and hemodynamic parameters and at the end of procedure recovery parameters were assessed.
Statistical Analysis Used


Data were described in terms of number (%) and mean ± standard deviation. Comparison of quantitative variables between the study groups was done using Student  t -test and Mann Whitney U test for parametric and nonparametric variables respectively. For comparing categorical data, Chi -square (χ2) test was performed.
Results


Mean motor seizure duration with etomidate (55.17 ± 19.06 s) was longer as compared to propofol (27.80 ± 17.33 s), and the difference was highly significant ( P  < 0.001). Among hemodynamic parameters, there was a significant increase in heart rate ( P  = 0.016) and significant fall in mean arterial pressure ( P  = 0.005) after induction with propofol as compared to etomidate.
Conclusion


Etomidate has the advantage of longer seizure duration and stable hemodynamics. It can be a useful alternative in patients achieving suboptimal therapeutic responses to ECT or where seizure duration is too short.",2020,"Among hemodynamic parameters, there was a significant increase in heart rate ( P  = 0.016) and significant fall in mean arterial pressure ( P  = 0.005) after induction with propofol as compared to etomidate.
","['Department of Anesthesia and Intensive care in a tertiary care hospital during 2018-2019', '70 patients, aged 18-65 years']","['ECT', 'Propofol (1%) - 1.0 mg.kg -1  and Group B - Etomidate 0.2 mg.kg -1  as an intravenous induction agent', 'Etomidate and propofol', 'propofol', 'propofol and etomidate', 'Etomidate', 'Propofol']","['motor seizure duration', 'induction time, hemodynamic parameters, recovery time, and adverse effects', 'Mean motor seizure duration', 'heart rate', 'seizure duration and stable hemodynamics', 'Intraoperatively, motor seizure duration, induction time, and hemodynamic parameters', 'mean arterial pressure']","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0242904', 'cui_str': 'General intravenous anesthetic'}]","[{'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",70.0,0.0816476,"Among hemodynamic parameters, there was a significant increase in heart rate ( P  = 0.016) and significant fall in mean arterial pressure ( P  = 0.005) after induction with propofol as compared to etomidate.
","[{'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Jindal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Gurkaran Kaur', 'Initials': 'GK', 'LastName': 'Sidhu', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Samiksha', 'Initials': 'S', 'LastName': 'Kumari', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Kamboj', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_5_20']
2414,32843795,Effect of Intraoperative Dexmedetomidine on Postoperative Pain and Pulmonary Function Following Video-assisted Thoracoscopic Surgery.,"Context


Acute postoperative pain following video-assisted thoracoscopic surgery (VATS) needs considerable attention, if untreated leads to chronic pain and postoperative lung dysfunction. Dexmedetomidine, α 2  adrenoceptor agonist has shown promising results of opioid-sparing effects.
Aims


The objectives of this study are to investigate the effect of dexmedetomidine on postoperative analgesia and pulmonary mechanics in patients undergoing VATS.
Settings and Design


This is a randomized controlled trial.
Subjects and Methods


We conducted a prospective, randomized, double-blind study on lung cancer patients undergoing VATS. Each patient received either dexmedetomidine or comparable volume of normal saline during the intraoperative period. In the recovery unit, postoperative visual analog scale (VAS) score, rescue analgesic requirements, arterial blood gas values, and pulmonary function tests were recorded.
Statistical Analysis Used


Data are analyzed using unpaired  t-test , Mann-Whitney U-test, and Fischer's exact test.  P  < 0.05 was considered statistically significant.
Results


VAS scores were significantly lower ( P  < 0.05) in the dexmedetomidine group at rest, on coughing and on mobilization from supine to sitting position. The partial pressure of arterial oxygen measured in postanesthesia care unit was significantly higher in the dexmedetomidine group (88 ± 8.2 vs 78 ± 9.1 mmHg). Forced expiratory volume in 1 was significantly greater in the dexmedetomidine group compared to the control group on the first 2 postoperative days ( P  < 0.05). The length of hospital stay was significantly reduced by dexmedetomidine.
Conclusions


Intraoperative dexmedetomidine administration improves the quality of analgesia and postoperative lung function in patients undergoing VATS.",2020,"Results


VAS scores were significantly lower ( P  < 0.05) in the dexmedetomidine group at rest, on coughing and on mobilization from supine to sitting position.","['patients undergoing VATS', 'lung cancer patients undergoing VATS']","['dexmedetomidine or comparable volume of normal saline', 'video-assisted thoracoscopic surgery (VATS', 'Dexmedetomidine', 'Video-assisted Thoracoscopic Surgery', 'dexmedetomidine', 'Intraoperative Dexmedetomidine']","['Forced expiratory volume', 'recovery unit, postoperative visual analog scale (VAS) score, rescue analgesic requirements, arterial blood gas values, and pulmonary function tests', 'quality of analgesia and postoperative lung function', 'postoperative analgesia and pulmonary mechanics', 'Results\n\n\nVAS scores', 'Postoperative Pain and Pulmonary Function', 'partial pressure of arterial oxygen measured in postanesthesia care unit', 'length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4075638', 'cui_str': 'Recovery unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.351639,"Results


VAS scores were significantly lower ( P  < 0.05) in the dexmedetomidine group at rest, on coughing and on mobilization from supine to sitting position.","[{'ForeName': 'Vinayaka', 'Initials': 'V', 'LastName': 'Jannu', 'Affiliation': 'Department of Anaesthesiology, J N Medical College, KAHER, Belagavi, Karnataka, India.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Dhorigol', 'Affiliation': 'Department of Anaesthesiology, J N Medical College, KAHER, Belagavi, Karnataka, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_9_20']
2415,32843799,The Comparison of Two Different Volumes of 0.5% Ropivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block Onset and Duration of Analgesia for Upper Limb Surgery: A Randomized Controlled Study.,"Background


The study is based on the fact that a lower volume of local anesthetic drugs for ultrasound-guided supraclavicular brachial plexus block is useful for upper limb surgeries lasting for a shorter duration, and result in a lower incidence of complications.
Aim


The aim of this study is to compare the effectiveness of 35 mL of 0.5% ropivacaine with 20 mL of 0.5% ropivacaine in ultrasound-guided supraclavicular brachial plexus block for upper limb surgery.
Setting


Patients undergoing upper limb surgery in an industry-based government hospital in New Delhi, India. Patients were followed in the operation theater and the recovery room.
Design


The study design involves a prospective, double-blind, randomized controlled trial.
Materials and Methods


A total of 40 participants were recruited for this study. Twenty participants in each group (referred to as group 20 and 30) received 20 mL and 35 mL of 0.5% ropivacaine, respectively, in ultrasound-guided supraclavicular brachial plexus block.
Statistical Analysis


The statistical analysis was performed using the software SPSS version 15 and a value of  P  < 0.05% was considered statistically significant. The statistical tests used included Student's  t -test to compare values between the two groups for the mean of parametric data, Mann-Whitney U-test for a median of nonparametric data, and Chi-square test or Fisher's exact test for the categorical data.
Results


The sensory and motor block onset in group 20 was 18.06 ± 3.04 and 23.89 ± 2.14 min, respectively. The sensory and motor block onset in group 30 was 17 ± 2.01 and 23.75 ± 2.22 min, respectively. The duration of analgesia in group 20 and 30 was 575.56 ± 104.39 and 730.75 ± 102.09 min, respectively ( P  < 0.001).
Conclusion


The onset of sensory and motor block of 20 mL of 0.5% ropivacaine is comparable to 35 mL of 0.5% ropivacaine for supraclavicular brachial plexus block for upper limb surgery. There was a 21% decrease in the duration of analgesia with a decrease in volume of 0.5% ropivacaine from 35 mL to 20 mL.",2020,"The duration of analgesia in group 20 and 30 was 575.56 ± 104.39 and 730.75 ± 102.09 min, respectively ( P  < 0.001).
","['Setting\n\n\nPatients undergoing upper limb surgery in an industry-based government hospital in New Delhi, India', 'A total of 40 participants were recruited for this study', 'Upper Limb Surgery', 'Twenty participants in each group (referred to as group 20 and 30) received']","['ropivacaine', '20 mL and 35 mL of 0.5% ropivacaine', 'ultrasound-guided supraclavicular brachial plexus block', 'Ropivacaine', 'ropivacaine with 20 mL of 0.5% ropivacaine']",['duration of analgesia'],"[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",40.0,0.0609417,"The duration of analgesia in group 20 and 30 was 575.56 ± 104.39 and 730.75 ± 102.09 min, respectively ( P  < 0.001).
","[{'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Chadha', 'Affiliation': 'Department of Anesthesia, Northern Railway Central Hospital, New Delhi, India.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Si', 'Affiliation': 'Department of Anesthesia, Northern Railway Central Hospital, New Delhi, India.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Bhatt', 'Affiliation': 'Department of Anesthesia, Northern Railway Central Hospital, New Delhi, India.'}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'Department of Anesthesia, Northern Railway Central Hospital, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesia, Northern Railway Central Hospital, New Delhi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesia, Northern Railway Central Hospital, New Delhi, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesia, Northern Railway Central Hospital, New Delhi, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_4_20']
2416,32843802,Prophylaxis versus Treatment against Transurethral Resection of Prostate Syndrome: The Role of Hypertonic Saline.,"Background


This study aimed at investigating the usage and effects of prophylactic hypertonic saline (HS) to prevent the occurrence of transurethral resection of the prostate (TURP) syndrome.
Materials and Methods


Sixty American Society of Anesthesiologists physical status classes I-III candidates for TURP using the monopolar resectoscope were randomized into three groups 20 patients each. Group A received 4 mL.kg -1 .h -1  HS 3%; Group B received 2 mL.kg -1 .h -1  HS 3%; and Group C received 6 mL.kg -1 .h -1  normal saline. Hemodynamics, vasopressors need, electrolytes (sodium, potassium, and chloride), osmolality, and arterial-blood gas (ABG) were recorded. The incidence of transurethral resection syndrome, intensive care unit (ICU) admission, postoperative ventilation, hospital stay as well as any adverse events were noted.
Results


Hypernatremia was detected in six patients ( P  = 0.002) of Group A only, while hyponatremia occurred in five patients ( P  = 0.009) of Group C alone. Serum sodium in Group C showed a significant decrease starting from T2 (1 h postresection) till Tp3 (48 h postoperative). In Group C, five patients experienced hypotension and bradycardia; hypertensive episodes also occurred in five patients and a hypervolemic state was noted in seven patients. TURP syndrome was confirmed in only five patients, all in Group C ( P  = 0.009). Postoperative ICU admission was needed for seven patients of C Group, five of which required assisted ventilation. The overall hospital stay was longer for Group C patients.
Conclusion


Prophylactic administration of HS during TURP is superior to conventional treatment of an occurred TURP syndrome. Low dose (2 mL.kg -1 .h -1  HS 3%) is effective without adverse effects or risk of contrary hypernatremia.",2020,Serum sodium in Group C showed a significant decrease starting from T2 (1 h postresection) till Tp3 (48 h postoperative).,"['Sixty American Society of Anesthesiologists physical status classes', 'Prostate Syndrome']","['Hypertonic Saline', 'Prophylaxis versus Treatment against Transurethral Resection', '4 mL.kg', 'prophylactic hypertonic saline (HS', 'monopolar resectoscope', 'TURP', '1  normal saline']","['hypotension and bradycardia; hypertensive episodes', 'incidence of transurethral resection syndrome, intensive care unit (ICU) admission, postoperative ventilation, hospital stay as well as any adverse events', 'TURP syndrome', 'Postoperative ICU admission', 'Hemodynamics, vasopressors need, electrolytes (sodium, potassium, and chloride), osmolality, and arterial-blood gas (ABG', 'overall hospital stay', 'Serum sodium', 'hypervolemic state', 'hyponatremia']","[{'cui': 'C0578808', 'cui_str': 'American Society of Anesthesiologists physical status class'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0520539', 'cui_str': 'Hypertensive episode'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0349610', 'cui_str': 'TUR syndrome'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0580179', 'cui_str': 'TURP syndrome'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]",60.0,0.114618,Serum sodium in Group C showed a significant decrease starting from T2 (1 h postresection) till Tp3 (48 h postoperative).,"[{'ForeName': 'Nazmy E', 'Initials': 'NE', 'LastName': 'Seif', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Hany A', 'Initials': 'HA', 'LastName': 'Shehab', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elbadawy', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_148_19']
2417,32843801,Effect of Intervertebral Level on Interlaminar Epidural Steroid Injection in Lumbar Spinal Canal Stenosis: A Randomized Controlled Trial.,"Background


Interlaminar epidural steroid injection (ILESI) is commonly performed nonsurgical intervention in patients with lumbar spinal stenosis. There is no consensus regarding appropriate intervertebral level of ILESI that leads to maximum effectiveness. In this study, we compared the efficacy of ILESI on pain relief and functional improvement when given at the level of maximum stenosis versus at nearby less stenotic levels in patients of lumbar canal stenosis.
Materials and Methods


In this study, 80 patients were randomly allocated to two groups: Group A received lumbar ILESI of 5mL bupivacaine (0.25%), 2 mL methylprednisolone acetate (40 mg/mL), and 1 mL normal saline at maximal stenotic intervertebral level, and Group B received the same drugs at less stenotic level, two intervertebral spaces cephalad or caudad to maximum stenosis. The effects were evaluated by Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI) at 2, 6, and 12 weeks after the intervention.
Results


Results of 30 patients in each group were assessed. Pain relief and improvement in ODI were observed in both groups after injection. Group A had significantly better pain relief at 2 and 4 weeks after injection. The ODI at 2, 6, and 12 weeks after injection was significantly lower in Group A as compared to Group B.
Conclusion


ILESI at maximum stenotic intervertebral level leads to better pain relief and functional improvement as compared to injection given at less stenotic level in lumbar spinal canal stenosis.",2020,"The ODI at 2, 6, and 12 weeks after injection was significantly lower in Group A as compared to Group B.
Conclusion


ILESI at maximum stenotic intervertebral level leads to better pain relief and functional improvement as compared to injection given at less stenotic level in lumbar spinal canal stenosis.","['patients of lumbar canal stenosis', '80 patients', 'patients with lumbar spinal stenosis', 'Lumbar Spinal Canal Stenosis']","['Intervertebral Level', 'ILESI', 'Interlaminar Epidural Steroid Injection', 'methylprednisolone acetate', '\n\n\nInterlaminar epidural steroid injection (ILESI', 'lumbar ILESI of 5mL bupivacaine']","['pain relief and functional improvement', 'Pain relief and improvement in ODI', 'pain relief', 'Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}]","[{'cui': 'C0442106', 'cui_str': 'Intervertebral'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0600901', 'cui_str': 'Methylprednisolone acetate'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",80.0,0.079551,"The ODI at 2, 6, and 12 weeks after injection was significantly lower in Group A as compared to Group B.
Conclusion


ILESI at maximum stenotic intervertebral level leads to better pain relief and functional improvement as compared to injection given at less stenotic level in lumbar spinal canal stenosis.","[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Bajpai', 'Affiliation': 'Associate Professor, Department of Anaesthesia, GIMSR, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Yelavarthi', 'Affiliation': 'Department of Orthopedics, GIMSR, Visakhapatnam, Andhra Pradesh, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_136_19']
2418,32843803,Normothermia versus Hypothermia during Cardiopulmonary Bypass in Cases of Repair of Atrioventricular Septal Defect.,"Background


Cardiopulmonary bypass (CPB) used for cardiac surgery is now uniformly carried out under normothermic conditions in adult patients; however, the temperature applied in pediatric CPB vary significantly, ranging from deep hypothermia to normothermia due to the lack of a consistent approach to CPB temperature in pediatric cardiac surgery, which is related to a lack of supportive evidence. Organs protection aim to decrease metabolic requirement and provide energy and oxygen, hypothermia has reached these goals by arresting and cooling the heart, delivering oxygen, and modifying reperfusion. Recently, a large number of studies investigated effect of hypothermia to decrease the negative impact of hypothermia. It has been suggested that the degree of hypothermia affects the inflammatory responses triggered by CPB. However, the use of normothermia during CPB had been introduced and resulted in acceptable results. We hypothesized that the use of normothermia during corrective surgery of AV septal defects improves the outcome of the CPB.
Objective


The study aimed to compare the outcome of normothermic technique and mild hypothermic technique during (CPB) in pediatric cardiac patients undergoing repair of atrioventricular (AV) septal defect and their effect on tissue perfusion, serum lactate level, duration of patient intubation, and postoperative hospital stay.
Patients and Methods


Forty patients presented for repair of AV defect aged from 1 month to 36 months were divided randomly into two equal groups (20 patients in each): Group I (Normothermic group) of body temperature more than 35°C up to 37°C and Group II (mild Hypothermic group) body temperature between (32°C-35°C). Basal data include complete blood count, electrolytes, arterial blood gases (ABGs), coagulation profile, and liver function tests were collected. Hemodynamic variables, ABG, serum lactate, and activated clotting time (ACT) measured in different time intervals related to CPB. With the termination of CPB, aortic cross-clamping time (minutes), CPB time (minutes), spontaneous regaining of the heart function, need for inotropic administration, and/or vasopressor requirements to wean the heart from CPB were reported in all patients.
Results


This study showed statistically significant lower PH and HCO3 levels and significantly higher serum lactate levels in Group II (hypothermic) than Group I (normothermic) after weaning from CPB. Furthermore, ACT level was statistically significantly higher in Group II than Group I after weaning of CPB. During postoperative period, hypothermic group showed significantly higher liver enzymes than the normothermic group. The duration of inotropes administration and duration of intubation were significantly longer in Group II than Group I.
Conclusion


Normothermia during CPB showed better global tissue perfusion than hypothermia in elective surgeries for repair of AV defects in the form of less degree of lactic acidosis, less effect on coagulation system, shorter duration of inotropic support, shorter intubation period, and shorter stay in the intensive care unit.",2020,"During postoperative period, hypothermic group showed significantly higher liver enzymes than the normothermic group.","['Cases of Repair of Atrioventricular Septal Defect', 'pediatric cardiac patients undergoing repair of atrioventricular (AV) septal defect', 'adult patients', 'Patients and Methods\n\n\nForty patients presented for repair of AV defect aged from 1 month to 36 months were divided randomly into two equal groups (20 patients in each']","['Normothermia versus Hypothermia', 'body temperature more than 35°C up to 37°C and Group II (mild Hypothermic group) body temperature', 'normothermic technique and mild hypothermic technique during (CPB', '\n\n\nCardiopulmonary bypass (CPB']","['PH and HCO3 levels', 'global tissue perfusion', 'Hemodynamic variables, ABG, serum lactate, and activated clotting time (ACT', 'coagulation system, shorter duration of inotropic support, shorter intubation period, and shorter stay', 'serum lactate levels', 'complete blood count, electrolytes, arterial blood gases (ABGs), coagulation profile, and liver function tests', 'tissue perfusion, serum lactate level, duration of patient intubation, and postoperative hospital stay', 'CPB, aortic cross-clamping time (minutes), CPB time (minutes), spontaneous regaining of the heart function, need for inotropic administration, and/or vasopressor requirements', 'liver enzymes', 'duration of inotropes administration and duration of intubation', 'ACT level']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1389016', 'cui_str': 'Atrioventricular Canal Defect'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0429877', 'cui_str': 'Tissue perfusion measure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}, {'cui': 'C0427611', 'cui_str': 'Coagulation time, activated'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0005790', 'cui_str': 'Blood coagulation panel'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0368930', 'cui_str': 'Coagulation time'}]",40.0,0.0335256,"During postoperative period, hypothermic group showed significantly higher liver enzymes than the normothermic group.","[{'ForeName': 'Ghada F', 'Initials': 'GF', 'LastName': 'Amer', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Mostafa S', 'Initials': 'MS', 'LastName': 'Elawady', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'ElDerie', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sanad', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Mansoura University, Egypt.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_123_19']
2419,32843809,Postoperative Analgesic Effect of Bupivacaine alone and with Dexmedetomidine in Wound Instillation for Lumbar Laminectomy: A Randomized Control Trial.,"Background


Dexmedetomidine has been used as an effective adjuvant to local anesthetics in peripheral nerve blocks and at the incision site.
Aims


We compared the postoperative analgesic effect of bupivacaine alone and in addition of dexmedetomidine to bupivacaine in wound instillation during lumbar laminectomy.
Setting and Design


This was a prospective, double-blind, randomized control trial.
Subjects and Methods


Sixty adults of the American Society of Anesthesiologists Grade I-II scheduled for elective lumbar laminectomy under general anesthesia were randomly allocated into two groups. Group B (control group) patients received wound instillation with 20 mL of 0.25% bupivacaine at the end of surgery and Group D patients received 2 μg.kg -1  dexmedetomidine diluted in 20 mL 0.25% bupivacaine as instillation over the incision site. If the NRS exceeded ""4"" at any point of time, rescue analgesia with injection diclofenac 75 mg deep intramuscular was administered. Postoperative pain score, duration of analgesia, total rescue analgesic required in the first 24 h, and side effects were compared between the groups.
Results


Demographic data were comparable in both the groups. Duration of analgesia (19.93 ± 3.2 in Group D vs. 12.13 ± 1.8 in Group B) was significantly more in Group D, number of analgesic demands were less in group D as compared to Group B, and total rescue analgesic required (62.51 ± 39.13 vs. 95.68 ± 33.5) was significantly less in Group D as compared to Group B.
Conclusions


We conclude that dexmedetomidine 2 μg.kg -1  is an effective adjuvant to bupivacaine for wound instillation in terms of quality and duration of postoperative analgesia following lumbar laminectomy.",2020,"Duration of analgesia (19.93 ± 3.2 in Group D vs. 12.13 ± 1.8 in Group B) was significantly more in Group D, number of analgesic demands were less in group D as compared to Group B, and total rescue analgesic required (62.51 ± 39.13 vs. 95.68 ± 33.5) was significantly less in Group D as compared to Group B.
Conclusions


","['Lumbar Laminectomy', 'Subjects and Methods\n\n\nSixty adults of the American Society of Anesthesiologists Grade I-II scheduled for elective lumbar laminectomy under general anesthesia']","['bupivacaine', 'Bupivacaine', 'Dexmedetomidine', 'dexmedetomidine diluted in 20 mL 0.25% bupivacaine', 'dexmedetomidine', 'diclofenac', 'wound instillation with 20 mL of 0.25% bupivacaine']","['Postoperative pain score, duration of analgesia, total rescue analgesic required in the first 24 h, and side effects', 'total rescue analgesic', 'number of analgesic demands', 'postoperative analgesic effect', 'Duration of analgesia']","[{'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",60.0,0.121579,"Duration of analgesia (19.93 ± 3.2 in Group D vs. 12.13 ± 1.8 in Group B) was significantly more in Group D, number of analgesic demands were less in group D as compared to Group B, and total rescue analgesic required (62.51 ± 39.13 vs. 95.68 ± 33.5) was significantly less in Group D as compared to Group B.
Conclusions


","[{'ForeName': 'Urvashi', 'Initials': 'U', 'LastName': 'Yadav', 'Affiliation': 'Department of Anaesthesiology, Uttar Pradesh University of Medical Sciences, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Department of Anaesthesiology, Uttar Pradesh University of Medical Sciences, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Srivastav', 'Affiliation': 'Department of Social and Preventive Medicine, Uttar Pradesh University of Medical Sciences, Etawah, Uttar Pradesh, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_3_20']
2420,32843808,Comparison of Magnesium Sulfate and Ketamine with Ropivacaine in Supraclavicular Brachial Plexus Block: A Randomized Controlled Trial.,"Background


Supraclavicular brachial plexus block offers good operating conditions with limited postoperative analgesia. Magnesium sulfate (MgSO 4 ) and ketamine block peripheral nociception mediated via N-methyl-D-aspartate receptors.
Aims


The aim of this study was to evaluate the effect of MgSO 4  and ketamine on the duration of analgesia in brachial block.
Settings and Design


This was a prospective, randomized, controlled double-blind study.
Materials and Methods


One hundred and five adult patients were randomly divided into three groups: Group I = 27 mL of 0.5% ropivacaine; Group II = 27 mL of 0.5% ropivacaine + 250 mg MgSO 4 ; and Group II = 27 mL of 0.5% ropivacaine + 2 mg.kg -1  ketamine. Normal saline was added to make a total volume of 30 mL. The onset and duration of the sensorimotor blockade, quality and duration of postoperative analgesia, and adverse effects were assessed.
Statistical Analysis


Statistical analysis was performed using SPSS, version 17.0 software (SPSS, Inc., Chicago, IL, USA). Chi-square test was used for nonparametric and ANOVA for parametric data.  Post hoc  Student's paired  t -test was applied wherever indicated. The results were expressed as mean and standard deviation or numbers (%).  P  < 0.05 was considered as statistically significant.
Results


The duration of analgesia was significantly longer in Group II (8.78 ± 0.97 h) compared to Group I (6.76 ± 0.92 h;  P  < 0.001) and Group III (7.1 ± 0.89 h;  P  < 0.001). Intervention groups had lower postoperative visual analog scores at 8, 12, and 24 h compared to the control group. Sedation, nystagmus, and hallucinations were observed in Group III.
Conclusion


The addition of MgSO 4  to ropivacaine in supraclavicular brachial plexus block significantly prolongs the duration of analgesia. MgSO 4  improves the quality of postoperative analgesia with lesser incidence of side effects when compared to ketamine.",2020,"Magnesium sulfate (MgSO 4 ) and ketamine block peripheral nociception mediated via N-methyl-D-aspartate receptors.
","['Supraclavicular Brachial Plexus Block', 'One hundred and five adult patients']","['Magnesium Sulfate and Ketamine with Ropivacaine', 'ropivacaine', 'ropivacaine + 250 mg MgSO 4 ; and Group II = 27 mL of 0.5% ropivacaine + 2 mg.kg -1  ketamine', 'ketamine', 'Normal saline', 'Magnesium sulfate (MgSO 4 ) and ketamine']","['postoperative visual analog scores', 'quality of postoperative analgesia', 'side effects', 'duration of analgesia', 'Sedation, nystagmus, and hallucinations', 'onset and duration of the sensorimotor blockade, quality and duration of postoperative analgesia, and adverse effects']","[{'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]",105.0,0.0727514,"Magnesium sulfate (MgSO 4 ) and ketamine block peripheral nociception mediated via N-methyl-D-aspartate receptors.
","[{'ForeName': 'Shubhdeep', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Jonny', 'Initials': 'J', 'LastName': 'Dhawan', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_96_19']
2421,32843810,Study of Tidal Volume and Positive End-Expiratory Pressure on Alveolar Recruitment Using Spiro Dynamics in Mechanically Ventilated Patients.,"Background and Aims


Ventilator setting in the intensive care unit patients is a topic of debate and setting of tidal volume (TV) should be patient-specific based on lung mechanics. In this study, we have evaluated to develop optimal ventilator strategies through continuous and thorough monitoring of respiratory mechanics during ongoing ventilator support to prevent alveolar collapse and alveolar injury in mechanically ventilated patients.
Methods


In our monocentric, randomized, observational study, we had recruited 60 patients and divided them into two groups of 30 each. In Group 1 patients, TV and positive end-expiratory pressure (PEEP) were set according to pressure-volume (P/V) curve obtained by the mechanical ventilator in a conventional manner (control group), and in Group 2, TV and PEEP were set according to P/V curve obtained by the mechanical ventilator using intratracheal catheter. PEEP and TV were set accordingly. TV, PEEP, and PaO 2 /FiO 2  (P/F) ratio at days 1, 3, and 7, mortality within 7 days and mortality within 28 days were measured in each group and compared.
Results


We found a significant difference between PEEP and P/F ratio in both groups while intragroup comparison at days 1, 3, and 7. After the intergroup comparison of Group 1 and 2, we observed a significant difference of PEEP and P/F ratio between the groups at day 7 and not on day 1 or 3.
Conclusion


This study concludes that optimal PEEP is more accurate using an intratracheal catheter than the conventional method of deciding ventilator setting. Hence, it is recommended to use intratracheal catheter to obtain more accurate ventilator settings.",2020,"We found a significant difference between PEEP and P/F ratio in both groups while intragroup comparison at days 1, 3, and 7.","['mechanically ventilated patients', '60 patients and divided them into two groups of 30 each', 'Mechanically Ventilated Patients', 'intensive care unit patients']",['Tidal Volume and Positive End-Expiratory Pressure'],"['TV, PEEP, and PaO 2 /FiO 2  (P/F) ratio', 'PEEP and P/F ratio', 'TV and positive end-expiratory pressure (PEEP', 'mortality within 7 days and mortality']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",60.0,0.0532023,"We found a significant difference between PEEP and P/F ratio in both groups while intragroup comparison at days 1, 3, and 7.","[{'ForeName': 'Shobhit', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesia and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Anesthesia and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Virendra', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesia and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Malviya', 'Affiliation': 'Department of Anesthesia and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Harjai', 'Affiliation': 'Department of Anesthesia and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Sujeet', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Department of Anesthesia and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_10_20']
2422,32843828,Effect of Taping of Thoracic and Abdominal Muscles on Pelvic Alignment and Forward Reach Distance Among Stroke Subjects: A Randomized Controlled Trial.,"INTRODUCTION


The objective of this study was to find the immediate as well as short-term effect on pelvic alignment and forward arm reach distance in sitting among stroke patients following thoracic spine and abdominal muscles taping along with conventional therapy.
METHODS


Thirty subjects with stroke attending the physiotherapy programme at Department of Physiotherapy at a tertiary care hospital underwent this randomized controlled experimental study. Subjects in the experimental group received taping, along with conventional physiotherapy treatment, for restricting thoracic kyphosis and facilitating abdominal muscles. Subjects in the control group received only conventional physiotherapy treatment. To assess the change in pelvic alignment and forward arm reach distance while sitting, Palpation Meter TM  (PALM TM ) and sit and reach test were used, respectively.
RESULTS


In the experimental group, pelvic obliquity was corrected (4.1  ±  0.94) and anterior pelvic tilt revealed improvement (4.9  ±  2.1,  p  value < 0.001). In the control group, no improvement in pelvic alignment was recorded. Improvement in forward arm reach distance was similar in both groups ( p  value = 0.804).
CONCLUSION


Taping as an adjunctive treatment method to physiotherapy can cause immediate as well as short-term improvement of pelvic alignment in sitting, following stroke. It also, immediately improves the sit and reach distance in the same population.",2019,"Improvement in forward arm reach distance was similar in both groups ( p  value = 0.804).
","['Thirty subjects with stroke attending the physiotherapy programme at Department of Physiotherapy at a tertiary care hospital', 'Stroke Subjects']","['thoracic spine and abdominal muscles taping along with conventional therapy', 'Taping', 'conventional physiotherapy treatment', 'Taping of Thoracic and Abdominal Muscles']","['change in pelvic alignment and forward arm reach distance while sitting, Palpation Meter TM  (PALM TM ) and sit and reach test', 'Pelvic Alignment and Forward Reach Distance', 'pelvic obliquity', 'pelvic alignment']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0581269', 'cui_str': 'Thoracic spine structure'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0264192', 'cui_str': 'Pelvic obliquity'}]",30.0,0.0413736,"Improvement in forward arm reach distance was similar in both groups ( p  value = 0.804).
","[{'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'College of Physiotherapy, Sumandeep Vidyapeeth an Institution Deemed to be University, Piparia, Gujarat, India.'}, {'ForeName': 'Abraham M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore; Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Suruliraj', 'Initials': 'S', 'LastName': 'Karthikbabu', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital, Bangalore; Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Zulkifli', 'Initials': 'Z', 'LastName': 'Misri', 'Affiliation': 'Department of Neurology, Kasturba Medical College, Mangalore; Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Bhaskaran', 'Initials': 'B', 'LastName': 'Unnikrishnan', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Mithra', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Akshatha', 'Initials': 'A', 'LastName': 'Nayak', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore; Manipal Academy of Higher Education, Manipal, India.'}]",Annals of neurosciences,['10.1177/0972753119887321']
2423,32844147,The corneal effects of intravitreal dexamethasone implantation.,"Objectives


To evaluate the corneal effects of the intravitreal dexamethasone implantation using corneal topography and specular microscopy.
Material and methods


27 eyes of the 27 patients who received a single intravitreal dexamethasone implantation dose for diabetic macular edema were enrolled in this study. Sirius topography and EM-3000 specular microscopic examinations were performed at the initial examination (baseline), and then on the first day, during the first week, and 1 month after IDI. Changes in corneal parameters were investigated.
Results


The mean age was 58.66 ± 6.59 years. 15 patients were men, and 12 were women. The mean disease duration was 12.2 ± 2.4 months, and mean glycosylated hemoglobin (HbA1c) was 7.2 ± 1.1. After dexamethasone injection, the mean central corneal thickness, endothelial cell density, and coefficient variation of cell area presented a statistically significant decrease ( p  < 0.05). Anterior segment parameters, such as anterior chamber depth, iridocorneal angle, sim K1 and K2 keratometry, pupillary diameter, horizontal visible iris diameter, and corneal astigmatism did not change ( p  > 0.05).
Conclusion


Intravitreal dexamethasone implantation affects corneal endothelial cell structure but does not appear to affect corneal topography parameters.",2020,"After dexamethasone injection, the mean central corneal thickness, endothelial cell density, and coefficient variation of cell area presented a statistically significant decrease ( p  < 0.05).","['27 eyes of the 27 patients who received a', 'The mean age was 58.66\u2009±\u20096.59\u2009years', '15 patients were men, and 12 were women', 'dose for diabetic macular edema']","['intravitreal dexamethasone implantation', 'dexamethasone', 'single intravitreal dexamethasone implantation', 'dexamethasone implantation']","['corneal endothelial cell structure', 'anterior chamber depth, iridocorneal angle, sim K1 and K2 keratometry, pupillary diameter, horizontal visible iris diameter, and corneal astigmatism', 'mean central corneal thickness, endothelial cell density, and coefficient variation of cell area', 'mean disease duration']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0429515', 'cui_str': 'Horizontal corneal diameter'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",27.0,0.0169449,"After dexamethasone injection, the mean central corneal thickness, endothelial cell density, and coefficient variation of cell area presented a statistically significant decrease ( p  < 0.05).","[{'ForeName': 'Alper Halil', 'Initials': 'AH', 'LastName': 'Bayat', 'Affiliation': 'Department of Ophthalmology, Esenler Hospital, Medipol University, APT: 5 Bahceler, AVE Esenler, Istanbul 34250, Turkey.'}, {'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Karataş', 'Affiliation': 'Department of Ophthalmology, Okmeydanı Research &Traning Hospital, University of Health Sciences, İstanbul, Turkey.'}, {'ForeName': 'Muhammet Mustafa', 'Initials': 'MM', 'LastName': 'Kurt', 'Affiliation': 'Department of Ophthalmology, Samsun Gazi State Hospital, Samsun, Turkey.'}, {'ForeName': 'Mustafa Nuri', 'Initials': 'MN', 'LastName': 'Elçioğlu', 'Affiliation': 'Department of Ophthalmology, Okmeydanı Research &Traning Hospital, University of Health Sciences, İstanbul, Turkey.'}]",Therapeutic advances in ophthalmology,['10.1177/2515841420947544']
2424,32844185,Newborn micronutrient status biomarkers in a cluster-randomized trial of antenatal multiple micronutrient compared with iron folic acid supplementation in rural Bangladesh.,"BACKGROUND


Daily antenatal multiple micronutrient (MM) compared with iron folic acid (IFA) supplementation from early pregnancy improved birth outcomes and maternal micronutrient status in rural Bangladesh, but effects on newborn status are unknown.
OBJECTIVE


We examined cord blood micronutrient biomarkers in relation to antenatal MM and IFA supplementation and maternal gestational micronutrient status in rural Bangladeshi newborns.
DESIGN


In a double-blinded, cluster-randomized trial of antenatal IFA or MM (with the same IFA content), we analyzed cord blood plasma from 333 singleton births, and corresponding maternal plasma at 32.5 ± 2.6 wk of gestation, for ferritin (iron stores), folate, cobalamin (vitamin B-12), retinol (vitamin A), 25-hydroxyvitamin D [25(OH)D, vitamin D status], α-tocopherol (vitamin E), zinc, thyroglobulin, and free thyroxine (iodine status). Intervention effects and associations were determined using linear regression, exploring maternal status as a mediator of intervention effects on cord biomarkers.
RESULTS


The MM intervention increased cord ferritin (mean: +12.4%; 95% CI: 1.3, 24.6%), 25(OH)D (mean: +14.7%; 95% CI: 4.8, 25.6%), and zinc (mean: +5.8%; 95% CI: 1.0, 10.8%). Cord folate (mean: +26.8%; 95% CI: 19.6, 34.5%), cobalamin (mean: +31.3%; 95% CI: 24.6, 38.3%), 25(OH)D (mean: +26.7%; 95% CI: 23.2, 30.3%), α-tocopherol (mean: +8.7%; 95% CI: 3.6, 13.7%), zinc (mean: +2.3%; 95% CI: 0.5, 4.2%), thyroglobulin (mean: +20.1%; 95% CI: 9.0, 32.2%) and thyroxine (mean: +1.5%; 95% CI: 0.0, 3.0%) increased per 1-SD increment in maternal status (all P < 0.05); ferritin and retinol changed by +2.0%; 95% CI: -8.9, 14.3%; P = 0.72; and +3.5%; 95% CI: -0.4, 7.3%; P = 0.07, respectively. Ferritin, folate, cobalamin, zinc, and thyroglobulin averaged 1.57-6.75 times higher and retinol, α-tocopherol, and 25(OH)D 0.30-0.84 times lower in cord than maternal plasma, suggesting preferential maternal-fetal transfer of iron, folate, cobalamin, and zinc; limited transfer of fat-soluble vitamins; and high fetal iodine demand.
CONCLUSIONS


Antenatal MM supplementation increased newborn ferritin, 25(OH)D, and zinc, while maternal and newborn folate, vitamins B-12, D, and E, zinc, and iodine biomarkers were positively related. Despite limited effects of MM, better maternal micronutrient status was associated with improved micronutrient status of Bangladeshi newborns. This trial was registered at clinicaltrials.gov as NCT00860470.",2020,"Ferritin, folate, cobalamin, zinc, and thyroglobulin averaged 1.57-6.75 times higher and retinol, α-tocopherol, and 25(OH)D 0.30-0.84 times lower in cord than maternal plasma, suggesting preferential maternal-fetal transfer of iron, folate, cobalamin, and zinc; limited transfer of fat-soluble vitamins; and high fetal iodine demand.
","['rural Bangladeshi newborns', 'rural Bangladesh']","['antenatal IFA or MM', 'Daily antenatal multiple micronutrient (MM) compared with iron folic acid (IFA) supplementation', 'IFA supplementation', 'antenatal multiple micronutrient compared with iron folic acid supplementation']","['newborn ferritin, 25(OH)D, and zinc, while maternal and newborn folate, vitamins B-12, D, and E, zinc, and iodine biomarkers', 'Cord folate', 'ferritin and retinol', 'Ferritin, folate, cobalamin, zinc, and thyroglobulin', 'cord ferritin', 'maternal gestational micronutrient status', ' 25-hydroxyvitamin D [25(OH)D, vitamin D status], α-tocopherol (vitamin E), zinc, thyroglobulin, and free thyroxine (iodine status', 'per 1-SD increment in maternal status', 'ferritin (iron stores), folate, cobalamin (vitamin B-12), retinol (vitamin A', 'α-tocopherol']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C1320396', 'cui_str': 'Maternal status'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}]",333.0,0.270589,"Ferritin, folate, cobalamin, zinc, and thyroglobulin averaged 1.57-6.75 times higher and retinol, α-tocopherol, and 25(OH)D 0.30-0.84 times lower in cord than maternal plasma, suggesting preferential maternal-fetal transfer of iron, folate, cobalamin, and zinc; limited transfer of fat-soluble vitamins; and high fetal iodine demand.
","[{'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Schulze', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Gernand', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Afreen Zaman', 'Initials': 'AZ', 'LastName': 'Khan', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lee S-F', 'Initials': 'LS', 'LastName': 'Wu', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'Mehra', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Abu Ahmed', 'Initials': 'AA', 'LastName': 'Shamim', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Pongtorn', 'Initials': 'P', 'LastName': 'Sungpuag', 'Affiliation': 'Institute of Nutrition, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Emorn', 'Initials': 'E', 'LastName': 'Udomkesmalee', 'Affiliation': 'Institute of Nutrition, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Alain B', 'Initials': 'AB', 'LastName': 'Labrique', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa223']
2425,32848491,The Efficacy and Safety of Highly-Bioavailable Curcumin for Treating Knee Osteoarthritis: A 6-Month Open-Labeled Prospective Study.,"Background


We previously developed a surface-controlled water-dispersible form of curcumin that we called Theracurmin ® . The area under the blood concentration-time curve (AUC) of Theracurmin in humans was 27-fold higher than that of curcumin powder. Previously, we reported on the anti-inflammatory effects of Theracurmin for knee osteoarthritis.
Hypothesis/Purpose


We determined the clinical effects of orally administered Theracurmin in patients with knee osteoarthritis over a 6-month period.
Study Design


Open prospective study.
Methods


Fifty patients Kellgren-Lawrence grade II, III, or IV knee osteoarthritis who were above 40 years old were enrolled in this clinical study. Theracurmin containing 180 mg/day of curcumin was administered orally every day for 6 months. To monitor for adverse events, blood biochemistry analyses were performed before and after 6 months of each intervention. The patients' knee symptoms were evaluated at 0, 1, 2, 3, 4, 5, and 6 months based on the Japanese Knee Osteoarthritis Measure, the knee pain visual analog scale, and the knee scoring system of the Japanese Orthopedic Association.
Results


Five cases dropped out during the study, but no cases dropped out because of major problems. No major side effects were observed with Theracurmin treatment, including the blood biochemistry analysis results. The effective group included 34 cases (75.6%), while the not-effective group included 11 cases.
Conclusion


This study demonstrates the safety and good efficacy of Theracurmin for various types of knee osteoarthritis. Theracurmin shows great potential for the treatment of human knee osteoarthritis.",2020,"No major side effects were observed with Theracurmin treatment, including the blood biochemistry analysis results.","['Treating Knee Osteoarthritis', 'human knee osteoarthritis', 'patients with knee osteoarthritis over a 6-month period', 'Fifty patients Kellgren-Lawrence grade II, III, or IV knee osteoarthritis who were above 40\u2009years old']","['Theracurmin', 'Theracurmin containing 180\u2009mg/day of curcumin', 'Highly-Bioavailable Curcumin']","['blood concentration-time curve (AUC) of Theracurmin', 'Japanese Knee Osteoarthritis Measure, the knee pain visual analog scale, and the knee scoring system of the Japanese Orthopedic Association']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",,0.0113473,"No major side effects were observed with Theracurmin treatment, including the blood biochemistry analysis results.","[{'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Orthopedic Surgery, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Mukai', 'Affiliation': 'Department of Orthopedic Surgery, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Orthopedic Surgery, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'Department of Orthopedic Surgery, Goshohigashi Clinic, Kyoto, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Yabumoto', 'Affiliation': 'Department of Orthopedic Surgery, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Department of Orthopedic Surgery, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Akamatsu', 'Affiliation': 'Department of Orthopedic Surgery, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.'}]",Clinical medicine insights. Arthritis and musculoskeletal disorders,['10.1177/1179544120948471']
2426,32842483,A Multiple Targeted Research Protocol for a Quasi-Experimental Trial in Primary School Children Based on an Active Break Intervention: The Imola Active Breaks (I-MOVE) Study.,"BACKGROUND


Children and adolescents should perform, according to the World Health Organization guidelines, at least 60 min of moderate-to-vigorous physical activity per-day in order to avoid the risk of metabolic and cardiovascular diseases. The school represents a fundamental setting to conduct interventions to promote physical activity (PA) and contrast sedentary behaviors. Active breaks (ABs), bouts of 10 min of PA conducted inside the classroom, seem to be a good strategy to promote PA and improve classroom behavior. The aim of this study protocol is to describe the design and the assessment of the Imola Active Breaks I-MOVE study.
METHODS


The I-MOVE study is a school-based intervention trial, with a quasi-experimental design, performed in a primary school. It involves one experimental-group performing the intervention, focused on ABs, and one control-group. Nine main outcomes are evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life.
CONCLUSIONS


Results from the I-MOVE study will help to clarify the effects of incorporating ABs in the Italian school curriculum as a new public health strategy and an innovative school model oriented to the well-being of children and teachers for the best quality of school life.",2020,"Nine main outcomes are evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life.
",['Primary School Children Based on an Active Break Intervention'],[],['evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life'],"[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0170705,"Nine main outcomes are evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life.
","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Masini', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Lanari', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': 'Department of Life Quality Studies, University of Bologna, Campus of Rimini, 47921 Rimini, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tessari', 'Affiliation': 'Department of Psychology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Stagni', 'Affiliation': 'Department of Electrical, Electronic, and Information Engineering ""Guglielmo Marconi"" University of Bologna, 40136 Bologna, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Bisi', 'Affiliation': 'Department of Electrical, Electronic, and Information Engineering ""Guglielmo Marconi"" University of Bologna, 40136 Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bragonzoni', 'Affiliation': 'Department of Life Quality Studies, University of Bologna, Campus of Rimini, 47921 Rimini, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Gori', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Sansavini', 'Affiliation': 'Department of Psychology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ceciliani', 'Affiliation': 'Department of Life Quality Studies, University of Bologna, Campus of Rimini, 47921 Rimini, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17176123']
2427,32842722,"The relative analgesic value of a femoral nerve block versus adductor canal block following total knee arthroplasty: a randomized, controlled, double-blinded study.","Background


Multiple comparative studies report that adductor canal blocks provide similar pain relief to femoral nerve blocks following total knee arthroplasty. However, adductor canal blockade fails to anesthetize several important femoral nerve branches that contribute to innervation of the knee. We sought to clarify this anatomic discrepancy by performing both blocks in sequence, using patients as their own controls. Our hypothesis was that patients would experience additional pain relief following a superimposed femoral nerve block, demonstrating that these two techniques are not equivalent.
Methods


Sixteen patients received continuous adductor canal block prior to undergoing total knee arthroplasty under general anesthesia. In the recovery room, patients were asked to report their pain score on a numeric rating scale of 0-10. Once a patient reached a score of five or greater, he/she was randomized to receive an additional femoral nerve block using 2% chloroprocaine or a sham femoral nerve block with saline, and pain scores were recorded every five minutes for 30 minutes. Patients were permitted opioid rescue as needed. Anesthesiologists performing and assessing the block efficacy were blinded to group allocation.
Results


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 minutes after the femoral block (2.0 vs. 5.5, p=0.0001). Patients receiving chloroprocaine also required significantly fewer morphine equivalents during the 30 minutes post-femoral block (1.0 vs. 4.5 mg, p=0.03).
Conclusions


Adductor canal block is a useful technique for postoperative pain following total knee arthroplasty, but it does not provide equivalent analgesic efficacy as femoral nerve block.",2020,"Results


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 minutes after the femoral block (2.0 vs. 5.5, p=0.0001).",['total knee arthroplasty'],"['additional femoral nerve block using 2% chloroprocaine', 'femoral nerve block versus adductor canal block', 'adductor canal blocks', 'continuous adductor canal block prior to undergoing total knee arthroplasty under general anesthesia', 'chloroprocaine']","['pain score', 'morphine equivalents', 'pain scores', 'median pain scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.56845,"Results


Patients randomized to chloroprocaine versus saline reported significantly improved median pain scores 30 minutes after the femoral block (2.0 vs. 5.5, p=0.0001).","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Gadsden', 'Affiliation': 'Associate Professor, Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sata', 'Affiliation': 'Assistant Professor, Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'W Michael', 'Initials': 'WM', 'LastName': 'Bullock', 'Affiliation': 'Assistant Professor, Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Kumar', 'Affiliation': 'Assistant Professor, Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Grant', 'Affiliation': 'Professor, Department of Anesthesiology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Dooley', 'Affiliation': 'Assistant Professor, Department of Anesthesiology, Duke University, Durham, NC, USA.'}]",Korean journal of anesthesiology,['10.4097/kja.20269']
2428,32842764,"""In the tube"" following sternotomy: A quasi-experimental study.","BACKGROUND


Traditionally, physical movement has been limited for cardiac surgery patients, up to 12-weeks post-operatively. Patients are asked to use ""standard sternal precautions,"" restricting their arm movement, and thereby limiting stress on the healing sternum.
AIM


To compare return to function, pain/discomfort, wound healing, use of pain medication and antibiotics, and post-operative length of hospital stay in cardiac surgery patients having median sternotomy who used standard sternal precautions or Keep Your Move in the Tube movement protocols post-operatively.
METHODS


A quasi-experimental design was used (100 standard sternal precautions and 100 Keep Your Move in the Tube patients). Patients were followed in person or by telephone over a period of 12-weeks postoperatively. Outcomes were measured at day 7, as well as weeks 4, 8, and 12 weeks.
RESULTS


The majority of participants (77% in each group) were male and had coronary artery bypass graft surgery (66% standard sternal precautions and 72% Keep Your Move in the Tube). Univariate analysis revealed the standard sternal precautions group had lesser ability to return to functional activities than the Keep Your Move in the Tube group ( p <0.0001) over time. This difference was minimized however, by week 12. Multivariate analysis revealed that increasing age, body mass index, and female sex were associated with greater functional impairment over time, but no difference between standard sternal precautions and Keep Your Move in the Tube groups.
CONCLUSIONS


Keep Your Move in the Tube, a novel patient-oriented movement protocol, has potential for cardiac surgery patients to be more confident and comfortable in their recovery.",2020,Univariate analysis revealed the standard sternal precautions group had lesser ability to return to functional activities than the Keep Your Move in the Tube group ( p <0.0001) over time.,['cardiac surgery patients having median sternotomy who used standard sternal precautions or Keep Your Move in the Tube movement protocols post-operatively'],[],"['return to function, pain/discomfort, wound healing, use of pain medication and antibiotics, and post-operative length of hospital stay', 'ability to return to functional activities', 'coronary artery bypass graft surgery']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",[],"[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",,0.030289,Univariate analysis revealed the standard sternal precautions group had lesser ability to return to functional activities than the Keep Your Move in the Tube group ( p <0.0001) over time.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Coltman', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Agren', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Colwell', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Canada.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'King-Shier', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Canada.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515120951981']
2429,32842769,Holmium Laser Enucleation versus Bipolar Plasmakinetic Resection for Management of Lower Urinary Tract Symptoms in Patients with Large Volume Benign Prostatic Hyperplasia: Randomised Controlled Trial.,"OBJECTIVES


To compare safety and efficacy of holmium laser enucleation (HoLEP) versus bipolar plasmakinetic resection (BPRP) of prostate in management of large sized (≥75gm) benign prostatic hyperplasia (BPH).
METHODS


This randomised controlled trial recruited 145 symptomatic BPH patients who had failed medical management, who underwent either HoLEP (Versa pulse®100W) (n=73) or BPRP (AUTOCON® II 400 ESU) (n= 72). Both groups were compared using Mann-Whitney, Chi-Square, Student-t or Fisher-Exact tests as appropriate. Preoperative vs postoperative findings (24-months) were compared using paired t-test or Wilcoxon-signed rank test.
RESULTS


The two groups were comparable for most preoperative findings including prostate size (p=0.629), although HoLEP included more patients on anticoagulants (p=0.001). HoLEP was associated with significantly less operative duration (p<0.001), hemoglobin loss (p<0.001), catheterisation duration (p=0.009) and hospital stay (p<0.001). There was no significant difference in total complications(p=0.291), and each separate complication. Blood transfusion was reported only with BPRP(p=0.058). At 24-months follow-up, there was significant improvement in all parameters in each group(IPSS, Qmax, QoL and PVRU; p<0.001). There was no significant difference between both groups in postoperative IPSS(p=0.08), Qmax(p=0.051), QoL(p=0.057), or PVRU(p=0.069).There was significantly better percentage improvement of both IPSS(p=0.006) and QoL(p=0.025) in HoLEP. HoLEP and smaller removed (resected or enucleated) tissues were associated with reduction in the primary outcomes (hemoglobin loss and operative duration) in logistic regression analysis.
CONCLUSION


HoLEP showed better safety profile with significantly less operative duration, hemoglobin loss, hospital stay and catheterization duration. Although both procedures were effective, HoLEP showed significantly better percentage improvement of both IPSS and QoL.",2020,"There was no significant difference between both groups in postoperative IPSS(p=0.08), Qmax(p=0.051), QoL(p=0.057), or PVRU(p=0.069).There was significantly better percentage improvement of both IPSS(p=0.006) and QoL(p=0.025) in HoLEP.","['Patients with Large Volume Benign Prostatic Hyperplasia', '145 symptomatic BPH patients who had failed medical management, who underwent either HoLEP (Versa pulse®100W) (n=73) or BPRP (AUTOCON® II 400 ESU) (n= 72', 'large sized (≥75gm) benign prostatic hyperplasia (BPH']","['HoLEP', 'bipolar plasmakinetic resection (BPRP', 'Holmium Laser Enucleation versus Bipolar Plasmakinetic Resection', 'holmium laser enucleation (HoLEP']","['total complications(p=0.291', 'safety and efficacy', 'operative duration', 'hemoglobin loss (p<0.001), catheterisation duration (p=0.009) and hospital stay', 'Blood transfusion', 'operative duration, hemoglobin loss, hospital stay and catheterization duration', 'IPSS and QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0180694', 'cui_str': 'Bovie'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",145.0,0.0490411,"There was no significant difference between both groups in postoperative IPSS(p=0.08), Qmax(p=0.051), QoL(p=0.057), or PVRU(p=0.069).There was significantly better percentage improvement of both IPSS(p=0.006) and QoL(p=0.025) in HoLEP.","[{'ForeName': 'Enmar', 'Initials': 'E', 'LastName': 'Habib', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology Department, Cairo, Egypt; enmar.habib@yahoo.com.'}, {'ForeName': 'Mohammed Said', 'Initials': 'MS', 'LastName': 'ElSheemy', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Urology department, Kasr AlAiny hospitals, Cairo university, Cairo, Outside U.S./Canada, Egypt, 12111.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hossam', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Cairo, Outside U.S./Canada, Egypt; ahmedhossam1975@yahoo.com.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Morsy', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Cairo, Outside U.S./Canada, Egypt; samer.morsy@yahoo.com.'}, {'ForeName': 'Hussein Aly', 'Initials': 'HA', 'LastName': 'Hussein', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Cairo, Outside U.S./Canada, Egypt; husseinalyhussein17@yahoo.com.'}, {'ForeName': 'Ahmed Yehia', 'Initials': 'AY', 'LastName': 'Abdelaziz', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Cairo, Outside U.S./Canada, Egypt; ahmedyehiaabdelaziz@yahoo.com.'}, {'ForeName': 'Mohammed Salah', 'Initials': 'MS', 'LastName': 'Abdelazim', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Cairo, Outside U.S./Canada, Egypt; mohammedsalahabdelazim@yahoo.com.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Fathy', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Cairo, Outside U.S./Canada, Egypt; heshamfathy14@yahoo.com.'}]",Journal of endourology,['10.1089/end.2020.0636']
2430,32842783,Captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms: rationale and design.,"Thoracic aortic aneurysms are correlated with significant mortality and morbidity. No therapy, however, is effective at limiting aneurysm expansion and preventing rupture. Angiotensin-converting enzyme inhibitors can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm. A total of 636 patients will be randomized into one of three parallel arms, receiving captopril, atenolol or placebo. The primary end point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months. The trial will investigate the efficacy of angiotensin-converting enzyme inhibitors versus beta-blocker therapy in reducing the growth rate of thoracic aortic aneurysms and rupture.  Trial registration number:  NCT04224675.",2020,The primary end point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months.,['636 patients'],"['Captopril', 'Angiotensin-converting enzyme inhibitors', 'atenolol', 'angiotensin-converting enzyme inhibitors versus beta-blocker therapy', 'captopril, atenolol or placebo']","['rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0003956', 'cui_str': 'Ascending aorta structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",636.0,0.0442182,The primary end point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spartalis', 'Affiliation': 'Division of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Tzatzaki', 'Affiliation': 'Division of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Dimitrios C', 'Initials': 'DC', 'LastName': 'Iliopoulos', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Spartalis', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Patelis', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Athanasiou', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': '1st Department of Cardiology, Hippokration Hospital, National & Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Voudris', 'Affiliation': 'Division of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Siasos', 'Affiliation': '1st Department of Cardiology, Hippokration Hospital, National & Kapodistrian University of Athens, Medical School, Athens, Greece.'}]",Future cardiology,['10.2217/fca-2020-0062']
2431,32842983,"Can broad-spectrum multinutrients treat symptoms of antenatal depression and anxiety and improve infant development? Study protocol of a double blind, randomized, controlled trial (the 'NUTRIMUM' trial).","BACKGROUND


Untreated antenatal depression and anxiety can be associated with short and long term health impacts on the pregnant woman, her infant and the rest of the family. Alternative interventions to those currently available are needed. This clinical trial aims to investigate the efficacy and safety of a broad-spectrum multinutrient formula as a treatment for symptoms of depression and anxiety in pregnant women and to determine the impact supplementation has on the general health and development of the infant.
METHODS


This randomised, controlled trial will be conducted in Canterbury, New Zealand between April 2017 and June 2022. One hundred and twenty women aged over 16 years, between 12 and 24 weeks gestation and who score ≥ 13 on the Edinburgh Postnatal Depression Scale (EPDS) will be randomly assigned to take the intervention (n = 60) or an active control formula containing iodine and riboflavin (n = 60) for 12 weeks. After 12 weeks, participants can enter an open-label phase until the birth of their infant and naturalistically followed for the first 12 months postpartum. Infants will be followed until 12 months of age. Randomisation will be computer-generated, with allocation concealment by opaque sequentially numbered envelopes. Participants and the research team including data analysts will be blinded to group assignment. The EPDS and the Clinical Global Impressions Scale of Improvement (CGI-I) will be the maternal primary outcome measures of this study and will assess the incidence of depression and anxiety and the improvement of symptomatology respectively. Generalized linear mixed effects regression models will analyse statistical differences between the multinutrient and active control group on an intent-to-treat basis. A minimum of a three-point difference in EPDS scores between the groups will identify clinical significance. Pregnancy outcomes, adverse events and side effects will also be monitored and reported.
DISCUSSION


Should the multinutrient formula be shown to be beneficial for both the mother and the infant, then an alternative treatment option that may also improve the biopsychosocial development of their infants can be provided for pregnant women experiencing symptoms of depression and anxiety.
TRIAL REGISTRATION


Trial ID: ACTRN12617000354381 ; prospectively registered at Australian New Zealand Clinical Trials Registry on 08/03/2017.",2020,"BACKGROUND


Untreated antenatal depression and anxiety can be associated with short and long term health impacts on the pregnant woman, her infant and the rest of the family.","['Canterbury, New Zealand between April 2017 and June 2022', 'pregnant women', 'pregnant women experiencing symptoms of depression and anxiety', 'One hundred and twenty women aged over 16\u2009years, between 12 and 24\u2009weeks gestation and who score\u2009≥\u200913 on the Edinburgh Postnatal Depression Scale (EPDS']","['active control formula containing iodine and riboflavin', 'broad-spectrum multinutrient formula']","['incidence of depression and anxiety', 'efficacy and safety', 'EPDS scores', 'Pregnancy outcomes, adverse events and side effects']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",120.0,0.24187,"BACKGROUND


Untreated antenatal depression and anxiety can be associated with short and long term health impacts on the pregnant woman, her infant and the rest of the family.","[{'ForeName': 'Hayley A', 'Initials': 'HA', 'LastName': 'Bradley', 'Affiliation': 'School of Psychology, Speech and Hearing, University of Canterbury, Private Bag 4800, Christchurch, 8041, New Zealand. hayley.bradley@pg.canterbury.ac.nz.'}, {'ForeName': 'Siobhan A', 'Initials': 'SA', 'LastName': 'Campbell', 'Affiliation': 'School of Psychology, Speech and Hearing, University of Canterbury, Private Bag 4800, Christchurch, 8041, New Zealand.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Mulder', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Jaqueline M T', 'Initials': 'JMT', 'LastName': 'Henderson', 'Affiliation': 'School of Psychology, Speech and Hearing, University of Canterbury, Private Bag 4800, Christchurch, 8041, New Zealand.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Dixon', 'Affiliation': 'New Zealand College of Midwives, Christchurch, New Zealand.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Boden', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Julia J', 'Initials': 'JJ', 'LastName': 'Rucklidge', 'Affiliation': 'School of Psychology, Speech and Hearing, University of Canterbury, Private Bag 4800, Christchurch, 8041, New Zealand.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03143-z']
2432,31102834,Evaluation of a comprehensive school physical activity program: Be a Champion!,"BACKGROUND


Comprehensive School Physical Activity Programs (CSPAPs) are widely supported to increase physical activity (PA) in schools, but little has been reported to inform a comprehensive evaluation effort. The purpose of this report is to describe a comprehensive evaluation and monitoring strategy for CSPAP implementation.
METHODS


The System for Observing Staff Promotion of Activity and Nutrition (SOSPAN), System for Observing Student Movement in Academic Routines and Transitions (SOSMART), and System for Observing Play and Leisure Activity (SOPLAY) were employed to record student and staff behaviors (2642 total scans). To assess policies, practices, and environments, a CSPAP Policies and Practices questionnaire was used, which included components of the School Health Index, the School PA Policy Assessment, the School Environment and Policies Survey, and the School Health Policies and Practices Study. Youth PA (minutes/day) was assessed using accelerometers.
RESULTS


Working with school sites to ascertain the number of opportunities that are provided for PA and the amount of PA students engage in is challenging but feasible. The use of systematic observation, accelerometers, and questionnaires can provide a comprehensive representation of policies, practices, and behaviors to aid in establishing targeted PA action items.
CONCLUSIONS


Developing an evaluation framework that was rigorous enough to assess the physical, social, and policy environment of a school in order to answer the overarching research questions of the study but flexible enough to be feasibly streamlined for utilization by a school implementation team proved to be challenging but possible.",2019,"The use of systematic observation, accelerometers, and questionnaires can provide a comprehensive representation of policies, practices, and behaviors to aid in establishing targeted PA action items.
",[],"['comprehensive school physical activity program', 'Comprehensive School Physical Activity Programs (CSPAPs']",[],[],"[{'cui': 'C0557796', 'cui_str': 'Comprehensive school'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.018721,"The use of systematic observation, accelerometers, and questionnaires can provide a comprehensive representation of policies, practices, and behaviors to aid in establishing targeted PA action items.
","[{'ForeName': 'Camelia R', 'Initials': 'CR', 'LastName': 'Singletary', 'Affiliation': 'Department of Family & Community Medicine, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA. Electronic address: crsingle@wakehealth.edu.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Weaver', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, 29208, USA. Electronic address: weaverrg@mailbox.sc.edu.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Carson', 'Affiliation': 'School of Sport and Exercise Science, College of Natural and Health Sciences, University of Northern Colorado, Greeley, CO, 80639, USA; PlayCore, 544 Chestnut St., Chattanooga, TN, 37402, USA. Electronic address: russell.carson@unco.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Beets', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, 29208, USA. Electronic address: beets@mailbox.sc.edu.'}, {'ForeName': 'Russell R', 'Initials': 'RR', 'LastName': 'Pate', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, 29208, USA. Electronic address: rpate@mailbox.sc.edu.'}, {'ForeName': 'Ruth P', 'Initials': 'RP', 'LastName': 'Saunders', 'Affiliation': 'Department of Health Promotion, Education, & Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC, 29208, USA. Electronic address: rsaunder@mailbox.sc.edu.'}, {'ForeName': 'Alexandra G', 'Initials': 'AG', 'LastName': 'Peluso', 'Affiliation': 'Department of Kinesiology and Health Education, College of Education, University of Texas at Austin, Austin, TX, 78712, USA. Electronic address: apeluso@utexas.edu.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'Department of Family & Community Medicine, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA; Department of Epidemiology & Prevention, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA; Department of Implementation Science, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA. Electronic address: jusmoore@wakehealth.edu.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2019.04.003']
2433,31826853,Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies.,"BACKGROUND/AIMS


To understand changes in disease activity as assessed by leakage and retinal fluid status in patients with neovascular age-related macular degeneration (nAMD) receiving fixed dosing with an anti-vascular endothelial growth factor (anti-VEGF) agent.
METHODS


In the phase III VIEW 1 (NCT00509795) and VIEW 2 (NCT00637377) studies, eyes with nAMD were treated with intravitreal aflibercept or ranibizumab. Independent, masked reading centres determined the presence/absence of leakage (fluorescein angiography) and retinal fluid (optical coherence tomography) at baseline, week 24 and week 52. In this integrated, post hoc analysis of the VIEW studies, the relationship between leakage/fluid status and best-corrected visual acuity (BCVA) was assessed. The impact of baseline lesion type (predominantly classic (PC), minimally classic (MC), occult) was also evaluated. Data from all treatment groups were pooled.
RESULTS


2373 eyes were included in this analysis. At baseline, 95.4% of eyes presented with both leakage and fluid. By week 52, leakage and fluid were present in 16.0% of eyes. Mean BCVA gains at week 52 were numerically greater in eyes without leakage and fluid versus eyes with both leakage and fluid (10.3 vs 9.2 letters). At week 52, 11.6%, 15.3% and 20.1% of eyes with PC, MC and occult lesions, respectively, had both leakage and fluid present.
CONCLUSION


In this post hoc analysis, fixed dosing with an anti-VEGF agent over 52 weeks eliminated disease activity (absence of both leakage and fluid) in most eyes. The effect of anti-VEGF treatment on leakage/fluid status favoured PC versus occult lesions.",2020,Mean BCVA gains at week 52 were numerically greater in eyes without leakage and fluid versus eyes with both leakage and fluid (10.3 vs 9.2 letters).,"['2373 eyes were included in this analysis', 'patients with neovascular age-related macular degeneration (nAMD) receiving fixed dosing with an']","['anti-VEGF', 'anti-vascular endothelial growth factor (anti-VEGF) agent', 'intravitreal aflibercept or ranibizumab']","['disease activity', 'leakage/fluid status and best-corrected visual acuity (BCVA', 'Mean BCVA gains', 'neovascular activity', 'presence/absence of leakage (fluorescein angiography) and retinal fluid (optical coherence tomography']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",2373.0,0.102473,Mean BCVA gains at week 52 were numerically greater in eyes without leakage and fluid versus eyes with both leakage and fluid (10.3 vs 9.2 letters).,"[{'ForeName': 'Darius M', 'Initials': 'DM', 'LastName': 'Moshfeghi', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California, USA dariusm@stanford.edu.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315021']
2434,32843005,Working conditions of healthcare workers and clients' satisfaction with care: study protocol and baseline results of a cluster-randomised workplace intervention.,"BACKGROUND


In the present investigation the study protocol and the results at baseline of a workplace intervention are reported. It is hypothesised that the reduction of the physical and psychosocial workload of healthcare workers increases 1 their self-assessed physical and mental work ability, and 2. clients' satisfaction with care.
METHODS


Two-arm, cluster-randomised trial. Outcome data on workers and clients are collected in questionnaires at baseline, and two follow-ups between 2019 and 2021. Participants of the interventions are healthcare workers of 11 healthcare providers in Germany. At baseline, the intervention arm comprised 22 clusters (n = 174 workers); the control arm, 47 clusters (n = 276). The intervention consists of interviews and workshops, in which employees propose measures aiming to reduce the physical and psychosocial load, and strengthen resources at work. The primary outcome is the workers' physical and mental work ability. The secondary outcome is the clients' satisfaction with care.
RESULTS


There was no evidence of substantial differences between trial arms at baseline concerning the outcomes. The design effect estimates for physical and mental work ability were 1.29 and 1.05, respectively. At the end of the trial, effect sizes of at least 0.30 and 0.27 at the 80% power and 5% significance levels can be attained.
CONCLUSIONS


The results suggest that the implementation of the study design has been satisfactory. The intervention is expected to provide evidence of relatively small to medium-size effects of the intervention activities on the work ability of healthcare workers and the clients' satisfaction with care.
TRIAL REGISTRATION


Registration trial DRKS00021138 on the German Registry of Clinical Studies (DRKS), retrospectively registered on 25 March, 2020.",2020,There was no evidence of substantial differences between trial arms at baseline concerning the outcomes.,"['Participants of the interventions are healthcare workers of 11 healthcare providers in Germany', ""healthcare workers and clients' satisfaction with care"", ""clients' satisfaction with care""]",[],"['physical and mental work ability', ""workers' physical and mental work ability"", ""clients' satisfaction with care""]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0883899,There was no evidence of substantial differences between trial arms at baseline concerning the outcomes.,"[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Montano', 'Affiliation': 'Department of Medical Sociology, Faculty of Medicine, Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Parkstr. 11, 89073, Ulm, Germany. diego.montano@uni-ulm.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Kuchenbaur', 'Affiliation': 'Department of Medical Sociology, Faculty of Medicine, Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Parkstr. 11, 89073, Ulm, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Geissler', 'Affiliation': 'Arbeit und Zukunft e.V, Hamburg, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Peter', 'Affiliation': 'Department of Medical Sociology, Faculty of Medicine, Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Parkstr. 11, 89073, Ulm, Germany.'}]",BMC public health,['10.1186/s12889-020-09290-4']
2435,32843021,"Efficacy of a smartphone-based intervention - ""Holidaily"" - promoting recovery behaviour in workers after a vacation: study protocol for a randomised controlled trial.","BACKGROUND


While work-related rumination increases the risk of acute stressors developing into chronic load reactions and adverse health, mental detachment has been suggested as a way to interrupt this chain. Despite the importance of mentally detaching from work during leisure time, workers seem to struggle to disengage and, instead, experience the constant mental representation of work-related stressors, regardless of their absence. Those who struggle with work-related rumination could benefit from an easy-access intervention that fosters mental detachment by promoting recreational activities. Especially during vacations, workers appear to naturally engage in sufficient recovery activities; however, this beneficial behaviour is not sustained. The smartphone app-based intervention ""Holidaily"" promotes recovery behaviour and, thus, mental detachment from work with the intension of extending the beneficial effects of workers' vacations into their daily working life.
METHODS


This randomised-controlled trial (RCT) evaluates the efficacy of ""Holidaily"". The Holidaily app is a German stand-alone program for mobile devices with either Android/iOS operating systems. The sample includes workers, who are awaiting to go on vacation and are randomly assigned to either the intervention (IG) or a waitlist-control group (CG). The IG receives two weeks pre-vacation access to Holidaily, while the CG receives access two weeks post-vacation. On a daily basis participants in the IG are provided with three options promoting recreational activities and beneficial recovery experiences. Online questionnaires are distributed to all participants at several timepoints. The primary outcome measure assesses participants' work-related rumination (Irritation Scale). A significant difference two weeks post-vacation is expected, favouring the IG. Secondary outcomes include symptoms of depression, insomnia severity, emotional exhaustion, thinking about work, recovery experiences, vacation specifics, work and personal characteristics. To help explain the intervention's effect, explorative analyses will investigate the mediation properties of the frequency of engaging in recreational activities and the moderation properties of Holidaily users' experiences.
DISCUSSION


If successful, workers will maintain their recovery behaviour beyond their vacation into daily working life. Findings could, therefore, provide evidence for low-intensity interventions that could be very valuable from a public-health perspective. App-based interventions have greater reach; hence, more workers might access preventative tools to protect themselves from developing adverse health effects linked to work-related rumination. Further studies will still be needed to investigate whether the vacation phenomenon of ""lots of fun quickly gone"" can be defied and long-term benefits attained.
TRIAL REGISTRATION


German Clinical Trials Registration DRKS00013650 . Registered retrospectively 15.01.2018.",2020,The Holidaily app is a German stand-alone program for mobile devices with either Android/iOS operating systems.,"['workers after a vacation', 'sample includes workers, who are awaiting to go on vacation']","['Holidaily', 'smartphone-based intervention - ""Holidaily"" ', 'waitlist-control group (CG']","[""participants' work-related rumination (Irritation Scale"", 'symptoms of depression, insomnia severity, emotional exhaustion, thinking about work, recovery experiences, vacation specifics, work and personal characteristics']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",3.0,0.16874,The Holidaily app is a German stand-alone program for mobile devices with either Android/iOS operating systems.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Smyth', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany. alexandra.smyth@stud.leuphana.de.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'de Bloom', 'Affiliation': 'Department of Human Resource Management and Organizational Behavior, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Syrek', 'Affiliation': 'Department of Occupational Psychology, University of Applied Sciences Bonn-Rhein Sieg, Rheinbach, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Domin', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Janneck', 'Affiliation': 'Department of Electrical Engineering and Computer Science, Technische Hochschule Luebeck, Luebeck, Germany.'}, {'ForeName': 'Jo Annika', 'Initials': 'JA', 'LastName': 'Reins', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lehr', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany.'}]",BMC public health,['10.1186/s12889-020-09354-5']
2436,32843171,Asthma rehabilitation at high vs. low altitude and its impact on exhaled nitric oxide and sensitization patterns: Randomized parallel-group trial.,"BACKGROUND


Allergens and pollution are reduced at high altitude. We investigated the effect of asthma rehabilitation at high altitude (HA, 3100 m) compared to low altitude (LA, 760 m) on exhaled nitric oxide (FeNO) and on specific IgE levels for house dust mites (HDM,d1) and common pollen (sx1).
METHODS


For this randomized controlled trial adult asthmatics living <1000 m were randomly assigned to a 3-week in-hospital-rehabilitation (education, physical- and breathing-exercises) at either LA or HA. Changes in FeNO, d1 and sx1 from baseline to end-rehabilitation were measured.
RESULTS


50 asthmatics (34 females) were randomized [mean ± standard deviation LA: n = 25, 44 ± 11 years, total IgE 267 ± 365kU/l; HA: n = 25, 43 ± 13 years, total IgE 350 ± 445kU/l]. FeNO significantly improved at HA from 69 ± 56 ppb at baseline to the first day at altitude 23 ± 19 ppb and remained decreased until end-rehabilitation with 37 ± 23 ppb, mean difference 95%CI -31(-50 to -13, p = 0.001) whereas at LA FeNO did not change. A significant decrease in d1 and sx1 at end-rehabilitation was observed in the LA-group [mean difference 95%CI -10.2 kUA/l (-18.9 to -1.4) for d1 and -4.95 kUA/l(-9.69 to -0.21) for sx1] but not in the HA-group. No significant difference between groups [d1 5.9 kUA/l(-4.2 to 16.2) and sx1 4.4 kUA/l(-3.5 to 12.4)] was found.
CONCLUSION


Rehabilitation at HA led to significant FeNO reduction starting from the first day until end-rehabilitation despite unchanged levels of specific IgE. The significant decrease in d1 and sx1 at end-rehabilitation in the LA group might be explained by less HDM in the hospital and/or reduced seasonal pollen, as this decrease was not observed at HA.",2020,A significant decrease in d1 and sx1 at end-rehabilitation was observed in the LA-group [mean difference 95%CI -10.2 kUA/l (-18.9 to -1.4) for d1 and -4.95 kUA/l(-9.69 to -0.21) for sx1] but not in the HA-group.,"['standard deviation LA: n\xa0=\xa025, 44\xa0±\xa011 years, total IgE 267\xa0±\xa0365kU/l', 'adult asthmatics living <1000\xa0m', '50 asthmatics (34 females) were randomized [mean\xa0±', 'HA: n\xa0=\xa025, 43\xa0±\xa013 years, total IgE 350\xa0±\xa0445kU/l']","['asthma rehabilitation at high altitude (HA, 3100\xa0m) compared to low altitude (LA, 760\xa0m', 'hospital-rehabilitation (education, physical- and breathing-exercises) at either LA or HA']","['exhaled nitric oxide (FeNO) and on specific IgE levels for house dust mites (HDM,d1) and common pollen (sx1', 'FeNO', 'exhaled nitric oxide and sensitization patterns', 'specific IgE', 'd1 and sx1 at end-rehabilitation']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517735', 'cui_str': '350'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C4517705', 'cui_str': '3100'}, {'cui': 'C0238618', 'cui_str': 'Low altitude'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0032385', 'cui_str': 'Pollen'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",,0.0858904,A significant decrease in d1 and sx1 at end-rehabilitation was observed in the LA-group [mean difference 95%CI -10.2 kUA/l (-18.9 to -1.4) for d1 and -4.95 kUA/l(-9.69 to -0.21) for sx1] but not in the HA-group.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Basler', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Saxer', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Schneider', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Bader', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Appenzeller', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bermet', 'Initials': 'B', 'LastName': 'Estebesova', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Berik', 'Initials': 'B', 'LastName': 'Emilov', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Talant M', 'Initials': 'TM', 'LastName': 'Sooronbaev', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Guillet', 'Affiliation': 'Allergy Unit, Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid-Grendelmeier', 'Affiliation': 'Allergy Unit, Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland. Electronic address: silvia.ulrich@usz.ch.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106040']
2437,32843205,Improving Door-to-Balloon Time for Patients With Acute ST-Elevation Myocardial Infarction: A Controlled Clinical Trial.,"According to the latest guidelines, the best intervention to restore blood flow through occluded coronary arteries is angioplasty at a time less than 90 minutes. Thereby, the present study was conducted to determine the impact of implementing ST-elevation myocardial infarction (STEMI) code on door-to-balloon time in patients with ST-segment elevation myocardial infarction. This clinical trial was conducted in 2019 at Booali Sina heart center hospital in Qazvin, Iran, in 2019. Fifty-eight patients with STEMI were purposively and consecutively enrolled in the study. Patients were then divided into control and intervention groups, based on their referral period. In both groups, patients were observed since their Arrived by emergency medical services to emergency department until inflating the balloon in the occluded coronary artery, and the intended times were recorded by the researchers. For Participants in the intervention group the ""STEMI code"" was designed and activated by an emergency physician once there is a patient experiencing a chest pain and early confirmed as a myocardial infarction. The SPSS program (v. 16) was used for data analysis at a significance level of less than 0.05. The difference in the door-to-balloon mean time in both control (113.5 ± 43.6 minutes) and intervention (79.3 ± 27.4 minutes) groups, was statistically significant (P = 0.001). Regarding other parameters, the reduction in the mean between Cath lab time (26.2 ± 18.2 minutes) and balloon time (15.5 ± 7.8 minutes) was also statistically significant (P = 0.008). In this study, implementation of the ""STEMI code"" could greatly prevent parallel work and squandering time while treating patients with acute myocardial infarction. As the door-to-balloon time gets shorter, the bed occupancy rate in the emergency department had reduced which in turn allowed more patients to be admitted.",2020,"The difference in the door-to-balloon mean time in both control (113.5 ± 43.6 minutes) and intervention (79.3 ± 27.4 minutes) groups, was statistically significant (P = 0.001).","['patients with ST-segment elevation myocardial infarction', 'patients with acute myocardial infarction', 'Patients With Acute ST-Elevation Myocardial Infarction', 'Fifty-eight patients with STEMI were purposively and consecutively enrolled in the study', '2019 at Booali Sina heart center hospital in Qazvin, Iran, in 2019']",[],"['door-to-balloon mean time', 'bed occupancy rate', 'balloon time', 'mean between Cath lab time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004909', 'cui_str': 'Bed Occupancy'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",58.0,0.0152122,"The difference in the door-to-balloon mean time in both control (113.5 ± 43.6 minutes) and intervention (79.3 ± 27.4 minutes) groups, was statistically significant (P = 0.001).","[{'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Namdar', 'Affiliation': ''}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'YekeFallah', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jalalian', 'Affiliation': ''}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Barikani', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Razaghpoor', 'Affiliation': ''}]",Current problems in cardiology,['10.1016/j.cpcardiol.2020.100674']
2438,32843213,Impact of a comprehensive functional rehabilitation programme on the quality of life of the oncological patient with dyspnoea.,"BACKGROUND


Dyspnoea is one of leading causes of loss of autonomy in patients with advanced-stage cancer. Pharmacological measures achieve a reduction of the symptom, but without generalizing this improvement to functionality. We propose the inclusion of a comprehensive functional rehabilitation programme. The purpose is to test the efficacy of an integral respiratory rehabilitation programme to improve autonomy levels and relieve cancer-related dyspnoea.
METHODS


Experimental design, prospective, longitudinal, randomized study based on a parallel fixed allocation scheme using an experimental group and a control group. The intervention group participated in comprehensive functional rehabilitation, while the control group only received standard drug treatment. Single blind masking, but statistical analysis was performed by non-study personnel.
RESULTS


Final sample of 113 individuals, 52 in the control group and 61 in the experimental group, from the Oncology Unit of the University Hospital Complex of Salamanca. Statistically significant differences (are observed) between the members of both groups in the levels of functionality (p = .000), in the levels of dyspnoea (p =.001) and in the sub-items of the Euro-QOL questionnaire, except in the sub-item related to pain (p = .311). No major adverse effects or side effects are observed.
CONCLUSION


Non-pharmacological interventions using a comprehensive functional rehabilitation programme improve functionality and relieve dyspnoea in cancer patients.",2020,"Statistically significant differences (are observed) between the members of both groups in the levels of functionality (p = .000), in the levels of dyspnoea (p =.001) and in the sub-items of the Euro-QOL questionnaire, except in the sub-item related to pain (p = .311).","['patients with advanced-stage cancer', 'cancer patients', 'Final sample of 113 individuals, 52 in the control group and 61 in the experimental group, from the Oncology Unit of the University Hospital Complex of Salamanca']","['integral respiratory rehabilitation programme', 'comprehensive functional rehabilitation, while the control group only received standard drug treatment', 'comprehensive functional rehabilitation programme']","['levels of functionality', 'levels of dyspnoea', 'functionality and relieve dyspnoea', 'quality of life of the oncological patient with dyspnoea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",113.0,0.023262,"Statistically significant differences (are observed) between the members of both groups in the levels of functionality (p = .000), in the levels of dyspnoea (p =.001) and in the sub-items of the Euro-QOL questionnaire, except in the sub-item related to pain (p = .311).","[{'ForeName': 'Eduardo José', 'Initials': 'EJ', 'LastName': 'Fernández Rodríguez', 'Affiliation': 'Servicio de Oncología Médica del Complejo Asistencial Universitario de Salamanca, Salamanca, España; Departamento de Enfermería y Fisioterapia. Universidad de Salamanca, Salamanca, España; Investigador Área Cáncer. Instituto de Investigación Biomédica de Salamanca, Salamanca, España. Electronic address: edujfr@usal.es.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Rihuete Galve', 'Affiliation': 'Servicio de Oncología Médica del Complejo Asistencial Universitario de Salamanca, Salamanca, España; Departamento de Enfermería y Fisioterapia. Universidad de Salamanca, Salamanca, España; Investigador Área Cáncer. Instituto de Investigación Biomédica de Salamanca, Salamanca, España.'}, {'ForeName': 'Juan Jesús', 'Initials': 'JJ', 'LastName': 'Cruz Hernández', 'Affiliation': 'Servicio de Oncología Médica del Complejo Asistencial Universitario de Salamanca, Salamanca, España; Investigador Área Cáncer. Instituto de Investigación Biomédica de Salamanca, Salamanca, España; Departamento de Medicina. Universidad de Salamanca, Salamanca, España.'}]",Medicina clinica,['10.1016/j.medcli.2020.05.058']
2439,32843240,Emotion Dysregulation Predicts Dropout from Prolonged Exposure Treatment among Female Veterans with Military Sexual Trauma-Related Posttraumatic Stress Disorder.,"BACKGROUND


Military sexual trauma (MST) is notably prevalent among military personnel and can result in mental and physical health problems, including post-traumatic stress disorder (PTSD). Although there are several evidence-based treatments for MST-related PTSD, including prolonged exposure (PE) therapy, it is unclear what factors are associated with premature termination (i.e., dropout) from this treatment. Given the popularity of PE as an evidence-based treatment for PTSD, the examination of variables that influence dropout from PE among women veterans with MST is warranted. Identification of these specific factors may assist clinicians in addressing the unique symptom profiles and potential barriers to treatment access for individual MST survivors.
METHODS


The current study presents secondary data analyses from an ongoing randomized clinical trial that compared the effectiveness of PE delivered in person to delivery via telemedicine for women veterans with MST-related PTSD (n = 136).
RESULTS


A total of 50% of participants dropped out from the study (n = 68). Difficulties with emotion regulation at baseline were associated with treatment dropout (odds ratio, 1.03; p < .01), whereas baseline PTSD and demographic factors were not.
CONCLUSIONS


Findings from the current study indicate that emotion regulation skills deficits contribute to PE dropout and may be an appropriate target to address in future clinical trials for PTSD.",2020,"Difficulties with emotion regulation at baseline were associated with treatment dropout (odds ratio, 1.03; p < .01), whereas baseline PTSD and demographic factors were not.
","['women veterans with MST-related PTSD (n\xa0=\xa0136', 'women veterans with MST', 'Female Veterans with Military Sexual Trauma-Related Posttraumatic Stress Disorder']",['Emotion Dysregulation Predicts Dropout from Prolonged Exposure Treatment'],['Difficulties with emotion regulation'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0523677,"Difficulties with emotion regulation at baseline were associated with treatment dropout (odds ratio, 1.03; p < .01), whereas baseline PTSD and demographic factors were not.
","[{'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gilmore', 'Affiliation': 'Department of Health Policy and Behavioral Sciences and Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, Atlanta, Georgia. Electronic address: agilmore12@gsu.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lopez', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Muzzy', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Wilson J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'School of Humanities & Social Sciences, Pennsylvania State University, The Behrend College, Erie, Pennsylvania.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Grubaugh', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina; Military Sciences Division, Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Oesterle', 'Affiliation': 'Department of Health Policy and Behavioral Sciences and Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, Atlanta, Georgia; Department of Psychological Sciences, College of Health and Human Sciences, Purdue University, West Lafayette, Indiana.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina; University of Texas Health Science Center at Houston, Houston, Texas.'}]",Women's health issues : official publication of the Jacobs Institute of Women's Health,['10.1016/j.whi.2020.07.004']
2440,32844300,Evaluating a low-fidelity inguinal canal model.,"PURPOSE


The inguinal canal anatomy is of paramount clinical significance due to the common occurrence of direct and indirect inguinal hernias. However, the inguinal canal is often an area of great difficulty for medical students to understand. The aim of this study was to evaluate the use of a low-cost, low-fidelity inguinal canal model as a teaching and learning aid.
METHODS


A low-fidelity inguinal canal model was introduced as a learning aid in an anatomy tutorial on the inguinal region. Students were randomised into intervention (n = 66) and control (n = 40) groups. Following the tutorial, all students completed a multiple-choice question quiz on the inguinal canal. The intervention group also completed a questionnaire evaluating the positive and negative aspects of the model.
RESULTS


Students taught with the inguinal canal model achieved higher scores (mean: 88.31% vs 81.7%, p = 0.087). Positive aspects of the model as described by the students included its simplicity and ability to improve their three-dimensional understanding of the inguinal canal. Students requested more hands-on time with the model during the tutorial.
CONCLUSION


The present study supports current literature in that low-fidelity anatomy models are a useful adjunct to aid students' learning of complex anatomical concepts. Students may benefit from creating their own inguinal canal model to retain as a personal study tool.",2020,"RESULTS


Students taught with the inguinal canal model achieved higher scores (mean: 88.31% vs 81.7%, p = 0.087).",[],"['low-cost, low-fidelity inguinal canal model']",[],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021445', 'cui_str': 'Inguinal canal structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],,0.018199,"RESULTS


Students taught with the inguinal canal model achieved higher scores (mean: 88.31% vs 81.7%, p = 0.087).","[{'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Hindmarch', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia. jakehindmarch19@gmail.com.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Bazzi', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lahoud', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Malik', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}, {'ForeName': 'Sankar', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}]",Surgical and radiologic anatomy : SRA,['10.1007/s00276-020-02553-0']
2441,32844309,Age is negatively associated with upper limb recovery after conventional but not robotic rehabilitation in patients with stroke: a secondary analysis of a randomized-controlled trial.,"BACKGROUND


There is consistent evidence that robotic rehabilitation is at least as effective as conventional physiotherapy for upper extremity (UE) recovery after stroke, suggesting to focus research on which subgroups of patients may better respond to either intervention. In this study, we evaluated which baseline variables are associated with the response after the two approaches.
METHODS


This is a secondary analysis of a randomized-controlled trial comparing robotic and conventional treatment for the UE. After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment. Variables associated with the response were identified in a univariate analysis. Then, variables independently associated with recovery were investigated, in the whole group, and the two groups separately.
RESULTS


A sample of 190 patients was evaluated after the treatment; 121 were responders. Age, baseline impairment, and neglect were significantly associated with worse response to the treatment. Age was the only independently associated variable (OR 0.967, p = 0.023). Considering separately the two interventions, age remained negatively associated with recovery (OR 0.948, p = 0.013) in the conventional group, while none of the variables previously identified were significantly associated with the response to treatment in the robotic group.
CONCLUSIONS


We found that, in our sample, age is significantly associated with the outcome after conventional but not robotic UE rehabilitation. Possible explanations may include an enhanced positive attitude of the older patients towards technological training and reduced age-associated fatigue provided by robotic-assisted exercise. The possibly higher challenge proposed by robotic training, unbiased by the negative stereotypes concerning very old patients' expectations and chances to recover, may also explain our findings.
TRIAL REGISTRATION NUMBER


NCT02879279.",2020,"After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment.","['A sample of 190 patients was evaluated after the treatment; 121 were responders', 'patients with stroke']",['robotic rehabilitation'],['Fugl-Meyer Assessment UE score'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",190.0,0.0894912,"After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Germanotta', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy. mgermanotta@dongnocchi.it.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Macchi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Montesano', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Galeri', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Diverio', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Catiuscia', 'Initials': 'C', 'LastName': 'Falsini', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Martini', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Mosca', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Langone', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Dionysia', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Carrozza', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aprile', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}]",Journal of neurology,['10.1007/s00415-020-10143-8']
2442,32844317,Comments on: 'Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'.,,2020,,[],['balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'],[],[],"[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.054021,,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'CORRIB Core Lab and Research Center for Advanced Imaging, National University of Ireland, Galway, Ireland. o.i.soliman@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Leipzig Heart Centre, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Ireland.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01484-0']
2443,32844328,Effects of Dating Matters® on Sexual Violence and Sexual Harassment Outcomes among Middle School Youth: a Cluster-Randomized Controlled Trial.,"Sexual violence (SV), including sexual harassment (SH), is a significant public health problem affecting adolescent health and well-being. This study extends prior research by evaluating the effectiveness of a comprehensive teen dating violence prevention model, Dating Matters, on SV and SH perpetration and victimization, inclusive of any victim-perpetrator relationship, among middle school students. Dating Matters includes classroom-delivered programs for youth in 6th, 7th, and 8th grades; community-based programs for parents; a youth communications program; training for educators; and community-level activities. Middle schools in four urban areas in the USA were randomly assigned to receive Dating Matters (DM, N = 22) or a standard-of-care intervention (SC, N = 24) over four consecutive school years (2012-2016). The analytic sample included two cohorts who entered the study in 6th grade and completed 8th grade by the end of the study allowing for full exposure to Dating Matters (DM: N = 1662; SC: N = 1639; 53% female; 50% black, non-Hispanic; 6 waves of data collection for each cohort). Structural equation modeling was employed with multiple imputation to account for missing data. Dating Matters was associated with significant reductions in SV and SH perpetration and victimization scores in most-but not all-sex/cohort groups by the end of 8th grade relative to an evidence-based TDV prevention program. On average, students receiving Dating Matters scored 6% lower on SV perpetration, 3% lower on SV victimization, 4% lower on SH perpetration, and 8% lower on SH victimization by the end of middle school than students receiving an evidence-based violence prevention program. Overall, Dating Matters shows promise for reducing SV and SH, occurring both within and outside dating relationships, through middle school. Clinicaltrials.gov Identifier: NCT01672541.",2020,Dating Matters was associated with significant reductions in SV and SH perpetration and victimization scores in most-but not all-sex/cohort groups by the end of 8th grade relative to an evidence-based TDV prevention program.,"['SC: N\u2009=\u20091639; 53% female; 50% black, non-Hispanic; 6 waves of data collection for each cohort', 'analytic sample included two cohorts who entered the study in 6th grade and completed 8th grade by the end of the study allowing for full exposure to Dating Matters', 'Middle schools in four urban areas in the USA', 'Middle School Youth', 'DM: N\u2009=\u20091662', 'middle school students']","['Dating Matters (DM, N\u2009=\u200922) or a standard-of-care intervention (SC, N\u2009=\u200924) over four consecutive school years', 'Dating Matters®']","['Sexual violence (SV), including sexual harassment (SH', 'SH victimization', 'SV and SH perpetration and victimization scores', 'Sexual Violence and Sexual Harassment Outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162790', 'cui_str': 'Sexual harassment'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0272559,Dating Matters was associated with significant reductions in SV and SH perpetration and victimization scores in most-but not all-sex/cohort groups by the end of 8th grade relative to an evidence-based TDV prevention program.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'DeGue', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA. sdegue@cdc.gov.'}, {'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Lianne Fuino', 'Initials': 'LF', 'LastName': 'Estefan', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Tracy', 'Affiliation': '2M Research, LLC, Arlington, TX, USA.'}, {'ForeName': 'Vi D', 'Initials': 'VD', 'LastName': 'Le', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Vivolo-Kantor', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Latzman', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Tharp', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Lang', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'NORC at the University of Chicago, Chicago, IL, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01152-0']
2444,32844366,Feasibility of Imported Self-Management Program for Elderly People with Chronic Pain: A Single-Arm Confirmatory Trial.,"INTRODUCTION


Multidisciplinary pain management programs incorporating a cognitive-behavioral therapy (CBT) approach have been reported to be helpful for elderly people with chronic pain. However, it is unclear whether the same program for elderly people with chronic pain would translate to different cultures. This study investigated whether a multidisciplinary program based on that of Nicholas et al. (Pain 154(6):824-835, 2013) in Australia would be effective for elderly people with chronic pain in Japan.
METHODS


Twenty-seven community-dwelling elderly people with chronic pain were enrolled to confirm changes (effect size d = 0.5) in pain disability, which were previously reported by Nicholas et al. The multidisciplinary program consisted of eight sessions (2 sessions a week for 4 weeks). Pain disability was assessed using the Pain Disability Assessment Scale (PDAS) as the primary outcome at the baseline, the beginning and the end of the program, and the 1- and 3-month (final) follow-up. We also assessed the pain severity, catastrophizing, pain self-efficacy, and physical function with the Timed Up and Go test (TUG) and the two-step test as secondary outcomes.
RESULTS


PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up. The effect size (d) for the PDAS score was a medium size (0.54) from baseline to 3-month follow-up. Those who showed improvements in TUG immediately after the program tended to report improved psychometric measures at 3-month follow-up.
CONCLUSION


These results suggest that the Japanese multidisciplinary program has a similar effect on pain disability as that reported by Nicholas et al. This finding has important implications for the development of pain services in community-dwelling elderly Japanese.",2020,"RESULTS


PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up.","['Twenty-seven community-dwelling elderly people with chronic pain', 'elderly people with chronic pain in Japan', 'elderly people with chronic pain', 'community-dwelling elderly Japanese', 'Elderly People with Chronic Pain']","['cognitive-behavioral therapy (CBT) approach', 'Imported Self-Management Program']","['psychometric measures', 'Pain disability', 'pain severity, catastrophizing, pain self-efficacy, and physical function with the Timed Up and Go test (TUG', 'PDAS, pain catastrophizing, and pain self-efficacy', 'pain disability', 'Pain Disability Assessment Scale (PDAS']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",,0.0331891,"RESULTS


PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up.","[{'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Ikemoto', 'Affiliation': 'Department of Orthopaedics, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Shiro', 'Affiliation': 'Nagoya Gakuin University, Nagoya, Japan. shiro823@ngu.ac.jp.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Ikemoto', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Young-Chang', 'Initials': 'YC', 'LastName': 'Arai', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Deie', 'Affiliation': 'Department of Orthopaedics, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beeston', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicholas', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}]",Pain and therapy,['10.1007/s40122-020-00192-2']
2445,32844378,"A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.","INTRODUCTION


To evaluate the efficacy and safety of sirukumab in giant cell arteritis (GCA).
METHODS


In this multicentre, randomised, double-blind, placebo-controlled, two-part phase 3 trial (NCT02531633; Part A [52-week double-blind treatment]; Part B [104-week follow-up]), patients with GCA were randomised (3:3:2:2:2) to sirukumab 100 mg every 2 weeks plus 6-month or 3-month prednisone taper, sirukumab 50 mg every 4 weeks plus 6-month prednisone taper, or placebo every 2 weeks plus 6-month or 12-month prednisone taper. The primary endpoint was the proportion of patients in sustained remission at week 52. Secondary endpoints included disease flare and safety. The study was terminated early (October 2017; sponsor decision).
RESULTS


Of 161 patients randomised (sirukumab: n = 107; placebo: n = 54), 28 (17.4%) completed week 52 (median treatment duration: 24-30 weeks). In a revised intent-to-treat (ITT) subgroup (completed week 52 or discontinued before study termination [n = 55]); six patients (all receiving sirukumab) achieved the primary endpoint. In the ITT population (n = 161), the proportion of patients with flares (week 2-52) was lower with sirukumab (18.4-30.8%) than placebo (37.0-40.0%). The proportion of patients with flares (week 2-12) was highest with sirukumab 100 mg every 2 weeks plus 3-month prednisone taper (23.1%). In Part A, 94.4% of patients reported ≥ 1 treatment-emergent adverse event (TEAE); 19.3% reported serious TEAEs. The proportions of patients with TEAEs were generally similar across treatment arms. No deaths occurred.
CONCLUSIONS


Although data were limited due to early termination and shortened treatment duration, sirukumab treatment resulted in numerically lower proportions of patients with flare by week 52 versus placebo, with no unexpected safety findings.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT02531633.",2020,"No deaths occurred.
","['patients with GCA', 'Giant Cell Arteritis', '161 patients randomised (sirukumab: n\u2009=\u2009107']","[' placebo', 'prednisone taper, or placebo', 'prednisone taper', 'placebo', 'Sirukumab', 'Placebo', 'sirukumab 100\xa0mg every 2\xa0weeks plus 6-month or 3-month prednisone taper, sirukumab 50\xa0mg']","['efficacy and safety', 'Efficacy and Safety', 'proportion of patients with flares', 'proportion of patients in sustained remission', 'disease flare and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039483', 'cui_str': 'Giant cell arteritis'}, {'cui': 'C3254570', 'cui_str': 'sirukumab'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C3254570', 'cui_str': 'sirukumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.382909,"No deaths occurred.
","[{'ForeName': 'Wolfgang A', 'Initials': 'WA', 'LastName': 'Schmidt', 'Affiliation': 'Medical Center for Rheumatology, Immanuel Krankenhaus Berlin (Buch), Berlin, Germany.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Dasgupta', 'Affiliation': 'Rheumatology, Southend University Hospital NHS Foundation Trust, Essex, UK.'}, {'ForeName': 'Raashid', 'Initials': 'R', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': 'Rheumatology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Blockmans', 'Affiliation': 'Department of General Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'Immunoinflammation, GlaxoSmithKline, Collegeville, PA, USA. zhihong.v.lai@gsk.com.'}, {'ForeName': 'Regina H', 'Initials': 'RH', 'LastName': 'Kurrasch', 'Affiliation': 'Immunoinflammation, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Lazic', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Immunoinflammation, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Immunology and Specialty Medicine, GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}]",Rheumatology and therapy,['10.1007/s40744-020-00227-2']
2446,32844217,Relating Bone Strain to Local Changes in Radius Microstructure Following 12 Months of Axial Forearm Loading in Women.,"Work in animal models suggest that bone structure adapts to local bone strain, but this relationship has not been comprehensively studied in humans. Here, we quantified the influence of strain magnitude and gradient on bone adaptation in the forearm of premenopausal women performing compressive forearm loading (n=11) and non-loading controls (n=10). High resolution peripheral quantitative computed tomography (HRpQCT) scans of the distal radius acquired at baseline and 12 months of a randomized controlled experiment were used to identify local sites of bone formation and resorption. Bone strain was estimated using validated finite element (FE) models. Trabecular strain magnitude and gradient were higher near (within 200 µm) formation versus resorption (p<0.05). Trabecular formation and resorption occurred preferentially near very high (>95th percentile) versus low (<5th percentile) strain magnitude and gradient elements, and very low strain elements were more likely to be near resorption than formation (p<0.05). In the cortical compartment, strain gradient was higher near formation versus resorption (p<0.05), and both formation and resorption occurred preferentially near very high versus low strain gradient elements (p<0.05). At most, 54% of very high and low strain elements were near formation or resorption only, and similar trends were observed in the control and load groups. These findings suggest that strain, likely in combination with other physiological factors, influences adaptation under normal loads and in response to a novel loading intervention, and represents an important step toward defining exercise interventions to maximize bone strength.",2020,Trabecular strain magnitude and gradient were higher near (within 200 µm) formation versus resorption (p<0.05).,"['premenopausal women performing compressive forearm loading (n=11) and non-loading controls (n=10', 'Radius Microstructure']",['High resolution peripheral quantitative computed tomography (HRpQCT) scans'],"['Bone strain', 'near formation or resorption', 'formation and resorption', 'Trabecular formation and resorption']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.024878,Trabecular strain magnitude and gradient were higher near (within 200 µm) formation versus resorption (p<0.05).,"[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': 'Department of Biomedical Engineering, Worcester Polytechnic Institute, 100 Institute Road, Worcester, MA 01609.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Troy', 'Affiliation': 'Department of Biomedical Engineering, Worcester Polytechnic Institute, 100 Institute Road, Worcester, MA 01609.'}]",Journal of biomechanical engineering,['10.1115/1.4048232']
2447,32844292,Native vs. active vitamin D in children with chronic kidney disease: a cross-over study.,"BACKGROUND


The rationale for the prescription of vitamin D analogues in patients with chronic kidney disease (CKD) is still a matter of debate. We aimed to compare native vs. active forms of vitamin D on pre-dialysis children with CKD and evaluate effects on calcium (Ca), phosphorus (P), and parathyroid hormone (PTH).
METHODS


Thirty children with pre-dialysis CKD were enrolled in a prospective cross-over study. Patients were randomly classified into two groups. Group A received native cholecalciferol while group B received alfacalcidol for 3 months. After 1 month (washout period), patients were switched to receive the opposite form for another 3 months. Serum Ca, P, alkaline phosphatase (ALP), PTH, and 25(OH)D 3  were measured at study start (BL-1), end of first period (FU-1), before second period (BL-2), and after second period (FU-2).
RESULTS


There was significant increase in levels of 25(OH)D 3  after administration of either native or active vitamin D in the first period in both groups (p < 0.001 and < 0.001, respectively) and also in the second period for both groups (p = 0.02 and < 0.001, respectively). There was no significant difference between both groups regarding changes in serum Ca (1st period; p = 0.770 and 2nd period; p = 0.412), serum P (1st period; p = 0.835, 2nd period; p = 0.052), and serum PTH (1st period; p = 0.250, 2nd period; p = 0.539).
CONCLUSION


Alfacalcidol and native vitamin D3 were equally effective in decreasing PTH levels and increasing serum 25(OH)D 3  in pre-dialysis CKD patients. There was no significant difference between the two forms regarding changes in serum Ca or P. Graphical abstract.",2020,Alfacalcidol and native vitamin D3 were equally effective in decreasing PTH levels and increasing serum 25(OH)D 3  in pre-dialysis CKD patients.,"['children with chronic kidney disease', 'pre-dialysis children with CKD', 'patients with chronic kidney disease (CKD', 'Thirty children with pre-dialysis CKD']","['Native vs. active vitamin D', 'native cholecalciferol', 'vitamin D', 'Alfacalcidol and native vitamin D3', 'vitamin D analogues']","['serum Ca or P. Graphical abstract', 'serum Ca', 'calcium (Ca), phosphorus (P), and parathyroid hormone (PTH', 'Serum Ca, P, alkaline phosphatase (ALP), PTH, and 25(OH)D 3', 'serum PTH', 'PTH levels', 'levels of 25(OH)D 3']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C1520059', 'cui_str': 'Vitamin D analog'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0165723,Alfacalcidol and native vitamin D3 were equally effective in decreasing PTH levels and increasing serum 25(OH)D 3  in pre-dialysis CKD patients.,"[{'ForeName': 'Happy', 'Initials': 'H', 'LastName': 'Sawires', 'Affiliation': 'Pediatric Nephrology Department, Cairo University, 5 El-Lithy Street El-Maadi El-Gedida, Cairo, 11435, Egypt. happy7_kd@yahoo.com.'}, {'ForeName': 'Fatina', 'Initials': 'F', 'LastName': 'Fadel', 'Affiliation': 'Pediatric Nephrology Department, Cairo University, 5 El-Lithy Street El-Maadi El-Gedida, Cairo, 11435, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hussein', 'Affiliation': 'Pediatric Nephrology Department, Cairo University, 5 El-Lithy Street El-Maadi El-Gedida, Cairo, 11435, Egypt.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Helmy', 'Affiliation': 'Pediatric Nephrology Department, Cairo University, 5 El-Lithy Street El-Maadi El-Gedida, Cairo, 11435, Egypt.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04721-1']
2448,32844540,High magnesium dialysate does not improve intradialytic hemodynamics or abrogate myocardial stunning.,"BACKGROUND


Hemodialysis (HD) induces myocardial stunning and is associated with adverse cardiovascular outcomes. Intradialytic hypotension is a modifiable determinant of myocardial stunning. Magnesium (Mg) is reported to be valuable in maintaining intradialytic blood pressure, which potentially would protect against demand myocardial ischemia. This study aimed to compare high vs. low dialysate Mg effects on intradialytic hemodynamics and HD-induced myocardial stunning.
METHODS


Twenty stable prevalent HD patients entered a randomized cross-over trial of low (0.5 mmol/L) vs. high (1.0 mmol/L) dialysate Mg. Patients were studied after 2 weeks of standard HD with each Mg concentration. Serial echocardiography assessed myocardial stunning, measured by left ventricular regional wall motion abnormalities (RWMAs). Continuous intradialytic hemodynamics were measured noninvasively using thoracic bioimpedance.
FINDINGS


Median predialysis serum Mg was higher with high dialysate Mg (1.45[1.29-1.55] vs. 1.03[0.98-1.1] mmol/L, P < 0.0001). There was no significant difference in maximum intradialytic reduction in systolic BP. There was no significant difference in stroke volume, total peripheral resistance, and cardiac output. Overall ventricular global longitudinal strain (GLS) (as a sensitive marker of contractile function) was higher before dialysis in high Mg group, but there was no difference in GLS at peak stress. However, we showed a significant correlation between Mg changes and GLS changes, r = -0.47, P = 0.02. There was no difference in mean number of peak stress RWMAs per patient (4.0 ± 2.2 vs. 4.3 ± 2.9, P = 0.5). Ultrafiltration volume, a critical determinant of stunning, was not different between high and low dialysate Mg studies (1.35[0-3.3] vs. 1.5[0-2.8], P = 0.49).
DISCUSSION


Manipulation of magnesium by altering dialysate magnesium concentration does not influence intradialytic hemodynamic response or HD-induced myocardial stunning in the short term. However, decreasing Mg changes appears to decrease GLS changes.",2020,"Overall ventricular global longitudinal strain (GLS) (as a sensitive marker of contractile function) was higher before dialysis in high Mg group, but there was no difference in GLS at peak stress.",['Twenty stable prevalent HD patients'],"['High magnesium dialysate', 'Magnesium (Mg']","['Median predialysis serum Mg', 'intradialytic hemodynamics or abrogate myocardial stunning', 'Intradialytic hypotension', 'Continuous intradialytic hemodynamics', 'Overall ventricular global longitudinal strain (GLS', 'mean number of peak stress RWMAs', 'intradialytic hemodynamic response or HD-induced myocardial stunning', 'stroke volume, total peripheral resistance, and cardiac output', 'maximum intradialytic reduction in systolic BP', 'Serial echocardiography assessed myocardial stunning, measured by left ventricular regional wall motion abnormalities (RWMAs', 'GLS changes']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0240292', 'cui_str': 'Mg++ increased'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0206146', 'cui_str': 'Myocardial stunning'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.0432526,"Overall ventricular global longitudinal strain (GLS) (as a sensitive marker of contractile function) was higher before dialysis in high Mg group, but there was no difference in GLS at peak stress.","[{'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Jefferies', 'Affiliation': 'Department of Renal Medicine, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lemoine', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'McIntyre', 'Affiliation': 'Lilibeth Caberto Kidney Clinical Research Unit, University of Western Ontario, London, Ontario, Canada.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12863']
2449,32844550,Postprandial Triglyceride-Rich Lipoproteins From Type 2 Diabetic Women Stimulate Platelet Activation Regardless of the Fat Source in the Meal.,"SCOPE


The aim of this study was to examine whether postprandial (PP) triglyceride-rich lipoproteins (TGRL) secreted after a moderate fat intake would activate platelets differently according to their fatty acid (FA) composition.
METHODS AND RESULTS


In a parallel single-blind randomized trial, 30 women with type 2 diabetes were assigned to a breakfast containing 20 g lipids from butter vs hazelnut cocoa spread rich in palm oil. Blood samples were collected at fasting and 4 h PP. FA composition of fasting and PP TGRL and their effects on the activation of platelets from healthy blood donors were assessed. Both breakfasts similarly increased plasma ApoB-48, plasma and TGRL triglycerides (p<0.05). TGRL mean diameter increased after both breakfasts and was greater after the butter breakfast. Both breakfasts were rich in palmitic acid, and the HCS breakfast contained 45% oleic acid. TGRL FA composition reflected the dietary FA composition. Pre-incubation of platelets with fasting and PP TGRL increased collagen-stimulated aggregation (p<0.01 vs control). Fasting and PP TGRL similarly increased agonist-induced thromboxane B 2  concentrations, and this effect was concentration-dependent for PP TGRL.
CONCLUSION


PP TGRL from type 2 diabetic women after a palm-oil spread vs butter-based mixed meal induce similar acute in vitro platelet activation. This article is protected by copyright. All rights reserved.",2020,"Both breakfasts similarly increased plasma ApoB-48, plasma and TGRL triglycerides (p<0.05).",['30 women with type 2 diabetes'],"['breakfast containing 20 g lipids from butter vs hazelnut cocoa spread rich in palm oil', 'PP TGRL']","['Postprandial Triglyceride-Rich Lipoproteins', 'incubation of platelets with fasting and PP TGRL increased collagen-stimulated aggregation', 'Blood samples', 'plasma ApoB-48, plasma and TGRL triglycerides', 'FA composition of fasting and PP TGRL', 'Platelet Activation', 'postprandial (PP) triglyceride-rich lipoproteins (TGRL', 'TGRL mean diameter']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0440288', 'cui_str': 'Hazelnut'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0069962', 'cui_str': 'Palm Oil'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1096194', 'cui_str': 'Lipoprotein (a) increased'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C0065060', 'cui_str': 'lipoprotein triglyceride'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",30.0,0.059224,"Both breakfasts similarly increased plasma ApoB-48, plasma and TGRL triglycerides (p<0.05).","[{'ForeName': 'Marie Michèle', 'Initials': 'MM', 'LastName': 'Boulet', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, Université Claude Bernard Lyon 1, IMBL, Villeurbanne, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheillan', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, Université Claude Bernard Lyon 1, IMBL, Villeurbanne, France.'}, {'ForeName': 'Mathilde Di', 'Initials': 'MD', 'LastName': 'Filippo', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, Université Claude Bernard Lyon 1, IMBL, Villeurbanne, France.'}, {'ForeName': 'Taïssia', 'Initials': 'T', 'LastName': 'Lelekov-Boissard', 'Affiliation': ""Fédération d'endocrinologie, Maladies Métaboliques, Diabète et Nutrition, Hôpital Louis Pradel, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Buisson', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, Université Claude Bernard Lyon 1, IMBL, Villeurbanne, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lambert-Porcheron', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, CENS, FCRIN/FORCE Network, Pierre Bénite, France.'}, {'ForeName': 'Julie-Anne', 'Initials': 'JA', 'LastName': 'Nazare', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, CENS, FCRIN/FORCE Network, Pierre Bénite, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tressou', 'Affiliation': 'UMR MIA-Paris, AgroParisTech, INRAE, Paris-Saclay University, Paris, France.'}, {'ForeName': 'Marie-Caroline', 'Initials': 'MC', 'LastName': 'Michalski', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, Université Claude Bernard Lyon 1, IMBL, Villeurbanne, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Calzada', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, Université Claude Bernard Lyon 1, IMBL, Villeurbanne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moulin', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, Université Claude Bernard Lyon 1, IMBL, Villeurbanne, France.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000694']
2450,32844557,Cardiorenal Outcomes with Dapagliflozin by Baseline Glucose Lowering Agents -Post-hoc Analyses from DECLARE-TIMI 58.,"AIMS


To assess the associations between baseline glucose-lowering agents (GLA) and cardiorenal outcomes with dapagliflozin vs. placebo in the DECLARE-TIMI 58 study.
METHODS


DECLARE-TIMI 58 assessed the cardiorenal outcomes of dapagliflozin vs. placebo in patients with type 2 diabetes. This post-hoc analysis elaborates the efficacy and safety outcomes by baseline GLA for treatment effect and GLA-based treatment interaction.
RESULTS


At baseline 14,068 patients (82.0%) used metformin, 7322 (42.7%) sulfonylureas, 2888 (16.8%) DPP-4 inhibitors, 750 (4.4%) GLP-1 receptor agonists (GLP-1 RA) and 7013 (40.9%) insulin. Dapagliflozin reduced the composite of cardiovascular death and hospitalization for heart failure (CVD/HHF) vs. placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP-1 RA (HR [95% CI] 0.37[0.18, 0.78] vs. 0.86[0.75,0.98] in GLP-1 RA users vs. non-users, p interaction  =0.03). The overall HR for major adverse cardiovascular events (CVD, myocardial infarction or ischemic stroke) was 0.93 (95% CI 0.84,1.03) with dapagliflozin vs placebo, with no interaction by baseline GLA (p interaction  >0.05). The renal specific outcome was reduced with dapagliflozin vs. placebo in the overall cohort (HR [95%CI] 0.53[0.43-0.66]), with no interaction by baseline GLA (p interaction  >0.05). All of these outcomes were similar in those with vs. without baseline metformin use.
CONCLUSIONS


The effects of dapagliflozin on cardiorenal outcomes were generally consistent regardless of baseline GLA, with consistent benefits regardless of baseline metformin use. The potential clinical benefit of combining SGLT-2 inhibitors with GLP-1 RA, given some evidence of cardiovascular risk reduction with both classes, should be further explored. This article is protected by copyright. All rights reserved.",2020,"Dapagliflozin reduced the composite of cardiovascular death and hospitalization for heart failure (CVD/HHF) vs. placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP-1 RA (HR [95% CI] 0.37[0.18, 0.78] vs. 0.86[0.75,0.98] in GLP-1 RA users vs. non-users, p interaction  =0.03).",['patients with type 2 diabetes'],"['GLP-1 receptor agonists (GLP-1 RA', 'dapagliflozin vs. placebo', 'metformin', 'Dapagliflozin', 'dapagliflozin vs placebo', 'SGLT-2 inhibitors with GLP-1 RA', 'dapagliflozin']","['cardiorenal outcomes', 'renal specific outcome', 'composite of cardiovascular death and hospitalization for heart failure', 'overall HR for major adverse cardiovascular events (CVD, myocardial infarction or ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",,0.300753,"Dapagliflozin reduced the composite of cardiovascular death and hospitalization for heart failure (CVD/HHF) vs. placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP-1 RA (HR [95% CI] 0.37[0.18, 0.78] vs. 0.86[0.75,0.98] in GLP-1 RA users vs. non-users, p interaction  =0.03).","[{'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, Faculty of Health and Life Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Litwak', 'Affiliation': 'Endocrinology Unit. Diabetes section, Hospital Italiano de Buenos Aires, Argentina.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kooy', 'Affiliation': 'University Medical Center Groningen and Bethesda Diabetes Research Center, Groningen, The Netherlands.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14179']
2451,32844575,The effects of laughter therapy on depression symptoms in patients undergoing center hemodialysis: A pragmatic randomized controlled trial.,"INTRODUCTION


People with end-stage renal disease undergoing hemodialysis are at increased risk for stress, anxiety, and depression. The study objective was to measure the effect of intradialytic group laughter therapy on depressive symptoms in people on hemodialysis (HD).
METHODS


Pragmatic randomized controlled trial conducted with prevalent HD patients in 10 centers in Northern California. The intervention group received a once weekly, 30-minute group laughter therapy session for 8 weeks. Primary outcome was the number of people with depressive symptoms as measured using the four Item Patient Health Questionnaire. Secondary outcomes were anxiety, subjective well-being, and patient-reported outcome measures.
FINDINGS


In all, 151 participants completed both predepression and postdepression symptom measures (72 intervention and 79 control). The proportion of patients with self-reported depressive symptoms changed from 17 (22%) to 16 (20%), in the control and from 11 (17%) to 5 (8%) in the intervention arms, respectively (P = 0.04). In the control arm, 7 out of the 17 patients with self-reported depressive symptoms at baseline continued to report depressive symptoms at follow up compared to the intervention arm where only 1 of 12 patients continued to report depressive symptoms. No differences were noted between the groups for reported anxiety, patient-reported dialysis symptoms, and subjective well-being.
DISCUSSION


This study found intradialytic group laughter can decrease the number of people with depressive symptoms receiving hemodialysis. Larger and long-term studies are required to evaluate the effect of intradialytic laughter on patient related outcomes and quality of life.",2020,"No differences were noted between the groups for reported anxiety, patient-reported dialysis symptoms, and subjective well-being.
","['people with depressive symptoms receiving hemodialysis', 'prevalent HD patients in 10 centers in Northern California', 'people on hemodialysis (HD', '151 participants completed both predepression and postdepression symptom measures (72 intervention and 79 control', 'patients undergoing center hemodialysis', 'People with end-stage renal disease undergoing hemodialysis']","['laughter therapy', 'intradialytic group laughter therapy']","['depression symptoms', 'number of people with depressive symptoms as measured using the four Item Patient Health Questionnaire', 'anxiety, subjective well-being, and patient-reported outcome measures', 'reported anxiety, patient-reported dialysis symptoms, and subjective well-being', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0949806', 'cui_str': 'Laughter Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",151.0,0.100771,"No differences were noted between the groups for reported anxiety, patient-reported dialysis symptoms, and subjective well-being.
","[{'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Bennett', 'Affiliation': 'Satellite Healthcare, Inc, San Jose, California, USA.'}, {'ForeName': 'Wael F', 'Initials': 'WF', 'LastName': 'Hussein', 'Affiliation': 'Satellite Healthcare, Inc, San Jose, California, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Reiterman', 'Affiliation': 'Satellite Healthcare, Inc, San Jose, California, USA.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Satellite Healthcare, Inc, San Jose, California, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Satellite Healthcare, Inc, San Jose, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12870']
2452,32844679,Tracking Valued and Avoidant Functions with Health Behaviors: A Randomized Controlled Trial of the Acceptance and Commitment Therapy Matrix Mobile App.,"This randomized controlled trial evaluated the acceptability and additive effects of self-monitoring avoidant and valued functions of behavior, in the context of self-monitoring physical activity and dietary behavior in a mobile app. The self-monitoring approach was based on the Acceptance and Commitment Therapy (ACT) Matrix. A sample of 102 adults interested in improving their diet and physical activity were randomized to a Health Behavior Tracking app (HBT), HBT plus ACT matrix app (HBT+ACT), or waitlist condition. Online self-report assessments were completed at baseline, mid (2 weeks), and post-intervention (4 weeks). Participants reported high usability, but mixed satisfaction with both apps. About half of the prompted app check-ins were completed on average, with 14% never using the ACT app. Participants in the HBT+ACT app condition reported greater self-reported physical activity over time relative to HBT and waitlist, potentially due to protecting against a decrease over time in physical activity observed in the other two conditions. HBT and HBT+ACT conditions both improved self-reported sedentary behavior relative to waitlist. HBT+ACT improved cognitive restraint with eating more than HBT. Neither the HBT or HBT+ACT app improved other health behavior outcome measures or values processes relative to the waitlist. Overall, findings suggest some benefits of the ACT Matrix app for addressing physical activity by tracking valued/avoidant functions, but mixed findings on acceptability, outcomes, and processes of change suggests impact may be relatively limited.",2020,Neither the HBT or HBT+ACT app improved other health behavior outcome measures or values processes relative to the waitlist.,"['102 adults interested in improving their diet and physical activity', 'Health Behaviors']","['Health Behavior Tracking app (HBT), HBT plus ACT matrix app (HBT+ACT), or waitlist condition', 'HBT and HBT+ACT', 'HBT or HBT+ACT']","['cognitive restraint', 'self-reported physical activity', 'physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",102.0,0.0653064,Neither the HBT or HBT+ACT app improved other health behavior outcome measures or values processes relative to the waitlist.,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Krafft', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Seifert', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lillis', 'Affiliation': 'Miriam Hospital, Providence, RI, USA.'}]",Behavior modification,['10.1177/0145445520913987']
2453,32844703,"The effect of evening cycling at different intensities on sleep in healthy young adults with intermediate chronobiological phenotype: A randomized, cross-over trial.","This study investigated the effect of various cycling intensities on sleep-related parameters in healthy young adults with intermediate chronobiological phenotype. Ten recreationally trained male volunteers underwent an evening i) moderate-intensity continuous training (MICT; 45 min at 70% W max ), ii) high-intensity interval training (HIIT; 10 × 1 min at 90% W max ), iii) sprint interval training (SIT; 6 × 20 sec at 140% W max ) or iv) a non-exercise (CON) trial in randomized, counter-balanced and crossover order. At baseline, somatometric data, maximum oxygen uptake and chronotype were evaluated. Sleep-related indices and daily activity were recorded by a multi-sensor activity monitor. Total sleep time was longer after SIT compared to CON and MICT ( p  < 0.05). Sleep efficiency was higher in SIT than in CON ( p  < 0.05). Sleep onset latency did not differ among trials. Wake after sleep onset was decreased after SIT compared to CON ( p = 0.049). No differences were found for bedtime among trials. Wake time was earlier in the MICT trial compared to CON ( p  = 0.026). Evening cycling exercise -independently of intensity- did not impair sleep of individuals with intermediate chronobiological phenotype. Furthermore, a single SIT session improved sleep quantity and continuation of individuals with this specific chronotype.",2020,Total sleep time was longer after SIT compared to CON and MICT ( p  < 0.05).,"['individuals with intermediate chronobiological phenotype', 'Ten recreationally trained male volunteers underwent an evening', 'healthy young adults with intermediate chronobiological phenotype']","['various cycling intensities', 'iii) sprint interval training (SIT', 'CON', 'single SIT session', 'i) moderate-intensity continuous training (MICT']","['Sleep efficiency', 'Sleep onset latency', 'Wake time', 'Sleep-related indices and daily activity', 'sleep quantity', 'somatometric data, maximum oxygen uptake and chronotype', 'Total sleep time', 'Wake after sleep onset']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",,0.0638136,Total sleep time was longer after SIT compared to CON and MICT ( p  < 0.05).,"[{'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Vlahoyiannis', 'Affiliation': 'Department of Life and Health Sciences, University of Nicosia , Nicosia, Cyprus.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Aphamis', 'Affiliation': 'Department of Life and Health Sciences, University of Nicosia , Nicosia, Cyprus.'}, {'ForeName': 'Daniel Ala', 'Initials': 'DA', 'LastName': 'Eddin', 'Affiliation': 'Department of Life and Health Sciences, University of Nicosia , Nicosia, Cyprus.'}, {'ForeName': 'Christoforos D', 'Initials': 'CD', 'LastName': 'Giannaki', 'Affiliation': 'Department of Life and Health Sciences, University of Nicosia , Nicosia, Cyprus.'}]",Journal of sports sciences,['10.1080/02640414.2020.1812194']
2454,32844712,"Testosterone treatment longer than 1 year shows more effects on functional hypogonadism and related metabolic, vascular, diabetic and obesity parameters (results of the 2-year clinical trial).","OBJECTIVE


We evaluated long-term effects of testosterone undecanoate on glycemic control, metabolic syndrome, vascular function and morphology in obese men with functional hypogonadism (FH) and type 2 diabetes (T2D) in a 2-year prospective clinical trial.
METHODS


A total of 55 participants were enrolled in this study; group P ( n  = 27) received placebo during first and testosterone therapy (TTh) during second year, group T ( n  = 28) received TTh both years. We pooled results after 1 year of TTh to obtain more statistical power. Results for group T after 2 years of TTh are also presented. We evaluated wide assortment of biochemical (fasting plasma glucose-FPG, glycated hemoglobin-HbA1c and lipid profile), hormonal, vascular (flow-mediated dilatation-FMD and intima-media thickness-IMT), anthropometrical and derived parameters (BMI, HOMA-IR, non-HDL cholesterol, bioavailable and calculated free testosterone). Quality of life was assessed using Aging Males' Symptoms (AMS) questionnaire.
RESULTS


FPG, HbA 1 c, HOMA-IR and IMT decreased, FMD increased, lipid profile and AMS sexual sub-score improved, and testosterone levels fully normalized after 2 years of TTh.
CONCLUSIONS


Two-year of TTh resulted in normalized serum testosterone levels, improved glycemia, endothelial function, lipids and insulin sensitivity, and quelled the symptoms of hypogonadism, potentially reducing cardiovascular risk in obese men with FH and T2D.",2020,"RESULTS


FPG, HbA 1 c, HOMA-IR and IMT decreased, FMD increased, lipid profile and AMS sexual sub-score improved, and testosterone levels fully normalized after 2 years of TTh.
","['55 participants were enrolled in this study; group P ( n \u2009=\u200927) received', 'obese men with FH and T2D', 'obese men with functional hypogonadism (FH) and type 2 diabetes (T2D']","['placebo during first and testosterone therapy (TTh', 'Testosterone', 'testosterone undecanoate']","['FPG, HbA 1 c, HOMA-IR and IMT decreased, FMD increased, lipid profile and AMS sexual sub-score improved, and testosterone levels', 'glycemic control, metabolic syndrome, vascular function and morphology', 'cardiovascular risk', 'Quality of life', ""Aging Males' Symptoms (AMS) questionnaire"", 'normalized serum testosterone levels, improved glycemia, endothelial function, lipids and insulin sensitivity, and quelled the symptoms of hypogonadism', 'functional hypogonadism and related metabolic, vascular, diabetic and obesity parameters', 'biochemical (fasting plasma glucose-FPG, glycated hemoglobin-HbA1c and lipid profile), hormonal, vascular (flow-mediated dilatation-FMD and intima-media thickness-IMT), anthropometrical and derived parameters (BMI, HOMA-IR, non-HDL cholesterol, bioavailable and calculated free testosterone']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0076195', 'cui_str': 'Testosterone undecanoate'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1136031', 'cui_str': 'Post-Transcriptional Gene Silencing'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}]",55.0,0.146655,"RESULTS


FPG, HbA 1 c, HOMA-IR and IMT decreased, FMD increased, lipid profile and AMS sexual sub-score improved, and testosterone levels fully normalized after 2 years of TTh.
","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Groti Antonič', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Blaž', 'Initials': 'B', 'LastName': 'Antonič', 'Affiliation': 'Blaž Antonič s.p, Ljubljana, Slovenia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Žuran', 'Affiliation': 'International Center for Cardiovascular Diseases-MC Medicor, Izola, Slovenia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Pfeifer', 'Affiliation': 'Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}]",The aging male : the official journal of the International Society for the Study of the Aging Male,['10.1080/13685538.2020.1793132']
2455,32844723,First Human Use of RUC-4: A Nonactivating Second-Generation Small-Molecule Platelet Glycoprotein IIb/IIIa (Integrin αIIbβ3) Inhibitor Designed for Subcutaneous Point-of-Care Treatment of ST-Segment-Elevation Myocardial Infarction.,"Background Despite reductions in door-to-balloon times for primary coronary intervention, mortality from ST-segment-elevation myocardial infarction has plateaued. Early pre-primary coronary intervention treatment of ST-segment-elevation myocardial infarction with glycoprotein IIb/IIIa inhibitors improves pre-primary coronary intervention coronary flow, limits infarct size, and improves survival. We report the first human use of a novel glycoprotein IIb/IIIa inhibitor designed for subcutaneous first point-of-care ST-segment-elevation myocardial infarction treatment. Methods and Results Healthy volunteers and patients with stable coronary artery disease receiving aspirin received escalating doses of RUC-4 or placebo in a sentinel-dose, randomized, blinded fashion. Inhibition of platelet aggregation (IPA) to ADP (20 μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments were made through 24 hours and at 7 days. Doses were increased until reaching the biologically effective dose (the dose producing ≥80% IPA within 15 minutes, with return toward baseline within 4 hours). In healthy volunteers, 15 minutes after subcutaneous injection, mean±SD IPA was 6.9%+7.1% after placebo and 71.8%±15.0% at 0.05 mg/kg (n=6) and 84.7%±16.7% at 0.075 mg/kg (n=6) after RUC-4. IPA diminished over 90 to 120 minutes. In patients with coronary artery disease, 15 minutes after subcutaneous injection of placebo or 0.04 mg/kg (n=2), 0.05 mg/kg (n=6), and 0.075 mg/kg (n=18) of RUC-4, IPA was 14.6%±11.7%, 53.6%±17.0%, 76.9%±10.6%, and 88.9%±12.7%, respectively. RUC-4 blood levels correlated with IPA. Aspirin did not affect IPA or RUC-4 blood levels. Platelet counts were stable and no serious adverse events, bleeding, or injection site reactions were observed. Conclusions RUC-4 provides rapid, high-grade, limited-duration platelet inhibition following subcutaneous administration that appears to be safe and well tolerated. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NTC03844191.",2020,"Inhibition of platelet aggregation (IPA) to ADP (20 μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments were made through 24 hours and at 7 days.","['Healthy volunteers and patients with stable coronary artery disease receiving', 'healthy volunteers', 'patients with coronary artery disease']","['glycoprotein IIb/IIIa inhibitors', 'novel glycoprotein IIb/IIIa inhibitor', 'RUC-4 or placebo', 'A Nonactivating Second-Generation Small-Molecule Platelet Glycoprotein IIb/IIIa (Integrin αIIbβ3', 'Aspirin', 'placebo', 'aspirin', 'RUC-4']","['Platelet counts', 'RUC-4 blood levels', 'mean±SD IPA', 'safe and well tolerated', 'Inhibition of platelet aggregation (IPA) to ADP (20\xa0μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments', 'IPA', 'IPA or RUC-4 blood levels', 'serious adverse events, bleeding, or injection site reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0061671', 'cui_str': 'ITGA2B protein, human'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",,0.084962,"Inhibition of platelet aggregation (IPA) to ADP (20 μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments were made through 24 hours and at 7 days.","[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'DeMaria', 'Affiliation': 'UC San Diego Health La Jolla CA.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Bentur', 'Affiliation': 'Allen and Frances Adler Laboratory of Blood and Vascular Biology Rockefeller University New York NY.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Precision for Medicine Carlsbad CA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Seng Yue', 'Affiliation': 'Learn and Confirm Inc. Saint-Laurent Quebec Canada.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Martin', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Midkiff', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Terah', 'Initials': 'T', 'LastName': 'Meek', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Garza', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Boston Clinical Research Institute Newton MA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Coller', 'Affiliation': 'Allen and Frances Adler Laboratory of Blood and Vascular Biology Rockefeller University New York NY.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016552']
2456,32844795,Effectiveness of Pressurized Normal Saline Irrigation of Subcutaneous Tissue Following Appendicectomy in Decreasing Wound Infection: A Quasi Experimental Study.,"Acute appendicitis is the commonest cause of acute abdomen necessitating surgical intervention and wound infection is the most frequently encountered complication following appendicectomy. To assess the effectiveness of pressurized normal saline irrigation of subcutaneous tissue following appendicectomy in decreasing wound infection this quasi experimental study was done in Surgery Unit III, Mymensingh Medical College Hospital from January 2018 to December 2018. In this study total 200 patients of acute appendicitis were enrolled according to inclusion and exclusion criteria and assigned equally into two groups by non-equivalent control group design. In control group all the standard protocol of wound closure following appendicectomy was followed and in experimental group along with the standard protocol the subcutaneous tissue was irrigated by pressure with normal saline and all the data were recorded in individual case record form. Among the sample most of the patients were between 10-19 years of ages and the male female ratio was 1.38:1. In control group 30% patients developed wound infection while 12% patients developed wound infection in experimental group with a P value of 0.027. Mean hospital stay of experimental group was less than the control group (P value less than 0.05). Overall postoperative outcome in context of wound infection and hospital stay is better following pressurized normal saline irrigation of subcutaneous tissue during closure.",2020,Overall postoperative outcome in context of wound infection and hospital stay is better following pressurized normal saline irrigation of subcutaneous tissue during closure.,"['Surgery Unit III, Mymensingh Medical College Hospital from January 2018 to December 2018', '200 patients of acute appendicitis', 'sample most of the patients were between 10-19 years of ages and the male female ratio was 1.38:1']","['pressurized normal saline irrigation', 'Pressurized Normal Saline Irrigation of Subcutaneous Tissue Following Appendicectomy']","['Wound Infection', 'Mean hospital stay', 'wound infection and hospital stay', 'wound infection']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]","[{'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",200.0,0.0381785,Overall postoperative outcome in context of wound infection and hospital stay is better following pressurized normal saline irrigation of subcutaneous tissue during closure.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Reza', 'Affiliation': 'Dr Ehsanur Reza, Associate Professor, Department of Surgery, Mymensingh Medical College, Mymensingh, Bangladesh.'}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Emon', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bhuiyan', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Habib', 'Affiliation': ''}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Khan', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
2457,32844806,Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial.,"Optimal enteral nutrition is essential for growth restricted preterm infants because if nutrition remains suboptimal during early days of life, physical and neuro-developmental outcome might be in danger. However, chronic hypoxia during antenatal period makes them susceptible for feeding intolerance and necrotising enterocolitis during post natal period. So this randomized clinical trial was conducted in the department of Neonatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from January 2018 to June 2019; to evaluate the effect of early versus delayed enteral feeding on preterm growth-restricted infants. During the study period, out of 127 infants with small for gestational age, 50 babies were enrolled and randomly assigned to either early feeding group (n=25) or late feeding group (n=25). Clinical characteristics at trial entry were well balanced between groups. Newborn enrolled in early feeding group reached full feed significantly faster than late feeding group (p=0.001; Hazard ratio 1.24). Early feeding group regained birth weight faster; experienced lesser incidence of neonatal sepsis, experienced less number of feed intolerance, had shorter mean duration of hospital stay and achieved higher weight on post natal age 16th days. All values were statistically significant. Early enteral feeding found to be safe and beneficial in reducing the time to reach full enteral feeding and better weight gain in growth restricted preterm infants.",2020,"Early feeding group regained birth weight faster; experienced lesser incidence of neonatal sepsis, experienced less number of feed intolerance, had shorter mean duration of hospital stay and achieved higher weight on post natal age 16th days.","['127 infants with small for gestational age, 50 babies', 'preterm growth-restricted infants', 'department of Neonatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from January 2018 to June 2019', 'Preterm Growth-Restricted Infants', 'growth restricted preterm infants']","['delayed enteral feeding', 'early feeding group (n=25) or late feeding group', 'Delayed Enteral Feeding']","['mean duration of hospital stay', 'neonatal sepsis, experienced less number of feed intolerance', 'weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0027621', 'cui_str': 'Neonatology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",127.0,0.0470463,"Early feeding group regained birth weight faster; experienced lesser incidence of neonatal sepsis, experienced less number of feed intolerance, had shorter mean duration of hospital stay and achieved higher weight on post natal age 16th days.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ahmed', 'Affiliation': 'Dr Farzana Ahmed, Associate Professor & Head, Department of Paediatrics, Marks Medical College Hospital, Dhaka, Bangladesh; E-mail: farzanaahmedpaed@gmail.com.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Dey', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shahidullah', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mannan', 'Affiliation': ''}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Raj', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sharmin', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
2458,32844807,A Comparative Study Between 20% Mannitol and 3% Hypertonic Saline for Brain Oedema Reduction during Elective Brain Tumour Surgery.,"Cerebral oedema is an important manifestation of brain tumour. The significant reduction of cerebral oedema can show rapid improvement of the patients. Hypertonic saline solution and mannitol both are commonly used for this action. It is now time to choose the better one. This was a prospective randomized comparative study designed to evaluate the efficacy of 3% hypertonic saline (NaCl) in reduction of brain oedema during brain tumour surgery and compare it with that of 20% Mannitol. The study was conducted in the department of Anaesthesiology, Combined Military Hospital, Dhaka, Bangladesh from July 2016 to December 2016. A total number of 47 patients for brain tumour surgery were selected. After screening 40 patients were finalized. Then the patients were divided into 2 equal groups 20 patients in each. Patients of Group A received 3% hypertonic saline and Group B 20% mannitol. Uniform anaesthetic technique applied for all patients, fixed surgeon/group of surgeons carried out the surgery. Heart rate and noninvasive blood pressure were monitored and kept with in ±20% baseline values different means. ETCO2 were kept in between 28-32mm of Hg by adjusting ventilator setting. Reduction of brain oedema was monitored by subjective assessment of surgeons using a 3 point scale of brain relaxation. The data were recorded in preformed data sheet. The results were tested by chi-square test to see their level of significance i.e. p value <0.05 was considered as significant. At the opening of dura, the number of brain conditions classified as soft, adequate and tight were statistically non-significant between groups. After 0.5 hour and 1.0 hour 10% patient's brain was tight in Group A whereas it was 35% and 40% in Group B respectively. Reduction of brain oedema or brain relaxation was significantly better in Group A compared to Group B (p<0.05). Urine output was higher with mannitol than hypertonic saline (p<0.05). Duration of ICU and hospital stay in both Group A and Group B were statistically similar (p>0.05). Compared to mannitol, hypertonic saline caused an increase in serum sodium concentration over time (p<0.05). From the available data, use of 20% mannitol and 3% hypertonic saline for brain oedema reduction, it is suggested that hypertonic saline significantly reduces the risk of tight brain and produce the brain more soft than mannitol during brain tumour surgery.",2020,Reduction of brain oedema or brain relaxation was significantly better in Group A compared to Group B (p<0.05).,"['47 patients for brain tumour surgery', 'department of Anaesthesiology, Combined Military Hospital, Dhaka, Bangladesh from July 2016 to December 2016']","['hypertonic saline and Group B 20% mannitol', '20% Mannitol', 'hypertonic saline (NaCl', 'Mannitol and 3% Hypertonic Saline', 'Hypertonic saline solution and mannitol', 'hypertonic saline', 'mannitol, hypertonic saline']","['Cerebral oedema', 'Heart rate and noninvasive blood pressure', 'risk of tight brain', 'serum sodium concentration', 'Urine output', 'brain oedema or brain relaxation', 'cerebral oedema', 'Duration of ICU and hospital stay', 'brain oedema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",40.0,0.0234874,Reduction of brain oedema or brain relaxation was significantly better in Group A compared to Group B (p<0.05).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haque', 'Affiliation': 'Major Dr Ariful Haque, Major, Classified Anaesthesiologist, Department of Anaesthesiology, CMH Savar, Savar Cantonment, Dhaka, Bangladesh; E-mail: haque_arif@yahoo.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Khalilullah', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Haque', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nancy', 'Affiliation': ''}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Ullah', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tusher', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jahan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abedin', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
2459,32844885,BDNF Val66Met polymorphism and resilience in major depressive disorder: the impact of cognitive psychotherapy.,"OBJECTIVE


Clinical and biological correlates of resilience in major depressive disorder are scarce. We aimed to investigate the effect of the Val66Met polymorphism in the BDNF gene on resilience scores in major depressive disorder patients and evaluate the polymorphism's moderation effect on resilience scores in response to cognitive therapy.
METHOD


A total of 106 major depressive disorder patients were enrolled in this clinical randomized study. The Resilience Scale and the Hamilton Rating Scale for Depression were applied at baseline, post-treatment, and at six months of follow-up. Blood samples were obtained at baseline for molecular analysis.
RESULTS


The baseline resilience scores were higher in patients with the Met allele (114.6±17.6) than in those with the Val/Val genotype (104.04±21.05; p = 0.037). Cognitive therapy treatment increased resilience scores (p ≤ 0.001) and decreased depressive symptoms (p ≤ 0.001). In the mixed-effect model, the Val/Val genotype represented a decrease in resilience scores (t218 = -1.98; p = 0.048), and the Val66Met polymorphism interacted with sex to predict an increase in total resilience scores during cognitive treatment (t218 = 2.69; p = 0.008).
CONCLUSION


Our results indicate that cognitive therapy intervention could improve resilience in follow-up, considering that gender and genetic susceptibility are predicted by the Val66Met polymorphism.",2020,Cognitive therapy treatment increased resilience scores (p ≤ 0.001) and decreased depressive symptoms (p ≤ 0.001).,"['106 major depressive disorder patients', 'major depressive disorder', 'major depressive disorder patients']","['Cognitive therapy', 'cognitive therapy intervention', 'cognitive psychotherapy']","['Resilience Scale and the Hamilton Rating Scale for Depression', 'Blood samples', 'total resilience scores', 'depressive symptoms', 'resilience scores', 'baseline resilience scores']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",106.0,0.0494011,Cognitive therapy treatment increased resilience scores (p ≤ 0.001) and decreased depressive symptoms (p ≤ 0.001).,"[{'ForeName': 'Renata B', 'Initials': 'RB', 'LastName': 'Peters', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Janaína', 'Initials': 'J', 'LastName': 'Xavier', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Thaíse C', 'Initials': 'TC', 'LastName': 'Mondin', 'Affiliation': 'Universidade Federal de Pelotas (UFPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Taiane de A', 'Initials': 'TA', 'LastName': 'Cardoso', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Ferreira', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Teixeira', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Kiane', 'Initials': 'K', 'LastName': 'Gräeff', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Luciana de A', 'Initials': 'LA', 'LastName': 'Quevedo', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Luciano D', 'Initials': 'LD', 'LastName': 'Souza', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Oses', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Ricardo T', 'Initials': 'RT', 'LastName': 'Pinheiro', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'da Silva', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ghisleni', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento (PPGSC), Universidade Católica de Pelotas (UCPel), Pelotas, RS, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0726']
2460,32844909,Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial.,"OBJECTIVES


compare an accelerated physiotherapeutic protocol to a conventional physiotherapeutic protocol in total hip arthroplasty patients.
METHODS


a randomized double blinded clinical trial performed from August 2013 to November 2014. Forty-eight patients diagnosed with hip osteoarthritis submitted to a total hip arthroplasty surgery. An accelerated rehabilitation physiotherapy applied three times a day and start gait training on the first day or standard physiotherapy applied once a day and start gait training on the second or third day of hospitalization. The Merle dAubigné and Postel score (mobility, pain and gait), muscle strength force, range of motion, in hospital stay and time to start of gait training, were the outcomes.
RESULTS


the mean age was 64.46 years (10.37 years standard deviation). No differences were observed in age in different genders, and the two randomization groups were homogeneous. In hospital stay was lower in the intervention group compared to the control group, 3 (3-4) days [median (interquartile range)] versus 4 (4-5) days. Time to the start of gait training was early in the intervention group compared to the control group, 1 (1-1) days versus 2 (2-2) days. Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction.
CONCLUSIONS


an accelerated physiotherapeutic protocol should be encouraged, because it shows favourable results in gait, muscle strength and length of hospital stay, even upon hospital discharge.",2020,"Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction.
","['the mean age was 64.46 years (10.37 years standard deviation', 'total hip arthroplasty patients', 'total hip arthroplasty (ARTHA', 'August 2013 to November 2014', 'Forty-eight patients diagnosed with hip osteoarthritis submitted to a total hip arthroplasty surgery']","['conventional physiotherapeutic protocol', 'Accelerated rehabilitation versus conventional rehabilitation']","['Higher muscle strength values', 'Time to the start of gait training', 'Merle dAubigné and Postel score (mobility, pain and gait), muscle strength force, range of motion, in hospital stay and time to start of gait training', 'hospital stay']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",48.0,0.111212,"Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction.
","[{'ForeName': 'Angela Elizabeth', 'Initials': 'AE', 'LastName': 'Marchisio', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Tiango Aguiar', 'Initials': 'TA', 'LastName': 'Ribeiro', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina Sant Anna', 'Initials': 'CSA', 'LastName': 'Umpierres', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'LÍvia', 'Initials': 'L', 'LastName': 'GalvÃo', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rosito', 'Affiliation': 'Hip Surgery of the Department of Orthopedic Surgery, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Carlos Alberto DE Souza', 'Initials': 'CAS', 'LastName': 'Macedo', 'Affiliation': 'Hip Surgery of the Department of Orthopedic Surgery, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Carlos Roberto', 'Initials': 'CR', 'LastName': 'Galia', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Revista do Colegio Brasileiro de Cirurgioes,['10.1590/0100-6991e-20202548']
2461,32844951,Effect of competence health cultivation on the prevention and control of inadvertent perioperative hypothermia.,"OBJECTIVE To explore the feasibility of health competence cultivation on the prevention and control of Inadvertent Perioperative Hypothermia (IPH). METHODS Patients with expected spinal surgery were divided into group A and group B by the random number method. Group B followed routine IPH management, and health training measures for performance and ability were implemented in Group A. The scores of the health competence questionnaire, the temperature at different times, IPH complications, and hospitalization for the two groups were observed and compared. RESULTS The main evaluation indexes, such as the health competence questionnaire score, temperature fluctuations, and IPH complications, during the perioperative period in group A were significantly better than those in group B (p < 0.05). The indexes of anesthesia, total hospital expenses, and health service satisfaction in group A were also significantly better than those in group B, which shows the advantages of cultivating health capabilities in both doctors and patients. CONCLUSION Through health competence cultivation and feasible health management measures, the medical staff can improve the quality of IPH prevention and management.",2020,"The scores of the health competence questionnaire, the temperature at different times, IPH complications, and hospitalization for the two groups were observed and compared.",['Patients with expected spinal surgery'],"['routine IPH management, and health training measures', 'competence health cultivation', 'health competence cultivation']","['indexes of anesthesia, total hospital expenses, and health service satisfaction', 'scores of the health competence questionnaire, the temperature at different times, IPH complications, and hospitalization', 'health competence questionnaire score, temperature fluctuations, and IPH complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150255', 'cui_str': 'Treatment of hypothermia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}]",,0.0143886,"The scores of the health competence questionnaire, the temperature at different times, IPH complications, and hospitalization for the two groups were observed and compared.","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Operative, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}, {'ForeName': 'Fu-Min', 'Initials': 'FM', 'LastName': 'Ping', 'Affiliation': 'Department of Operative, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Liu', 'Affiliation': '3Department of Pain, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}, {'ForeName': 'Jing-Lan', 'Initials': 'JL', 'LastName': 'He', 'Affiliation': '3Department of Pain, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}, {'ForeName': 'Shu-Fang', 'Initials': 'SF', 'LastName': 'Du', 'Affiliation': '3Department of Pain, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}, {'ForeName': 'Pei-Zhao', 'Initials': 'PZ', 'LastName': 'Shi', 'Affiliation': '3Department of Pain, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': '3Department of Pain, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}, {'ForeName': 'Ji-Yue', 'Initials': 'JY', 'LastName': 'Shi', 'Affiliation': 'Department of Pain, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.7.924']
2462,32845021,Supplementation-induced increase in circulating omega-3 serum levels is not associated with a reduction in depressive symptoms: Results from the MooDFOOD depression prevention trial.,"BACKGROUND


There is ambiguity on how omega-3 (n-3) polyunsaturated fatty acids (PUFAs) are associated with depression, and what the temporality of the association might be. The present study aimed to examine whether (intervention-induced changes in) n-3 PUFA levels were associated with (changes in) depressive symptoms.
METHODS


Baseline, 6- and 12-month follow-up data on 682 overweight and subclinically depressed persons from four European countries that participated in the MooDFOOD depression prevention randomized controlled trial were used. Participants were allocated to four intervention groups: (a) placebos, (b) placebos and food-related behavioral activation therapy (F-BA), (c) multinutrient supplements (fish oil and multivitamin), and (d) multinutrient supplements and F-BA. Depressive symptoms were measured using the inventory of depressive symptomatology. PUFA levels (µmol/L) were measured using gas chromatography. Analyses were adjusted for sociodemographics, lifestyle, and somatic health.
RESULTS


Increases in n-3 PUFA, docosahexaenoic acid, and eicosapentaenoic acid levels over time were significantly larger in the supplement groups than in placebo groups. Change in PUFA levels was not significantly associated with the change in depressive symptoms (β = .002, SE = 0.003, p = .39; β = .003, SE = 0.005, p = .64; β = .005, SE = 0.005, p = .29; β = -.0002, SE = 0.0004, p = .69). Baseline PUFA levels did not modify the intervention effects on depressive symptoms.
CONCLUSIONS


In overweight and subclinical depressed persons, multinutrient supplements led to significant increases in n-3 PUFA levels over time, which were not associated with changes in depressive symptoms. Multinutrient supplements do not seem to be an effective preventive strategy in lowering depressive symptoms over time in these at-risk groups.",2020,"Change in PUFA levels was not significantly associated with the change in depressive symptoms (β = .002, SE = 0.003, p = .39; β = .003, SE = 0.005, p = .64; β = .005, SE = 0.005, p = .29; β = -.0002, SE = 0.0004, p = .69).",['682 overweight and subclinically depressed persons from four European countries that participated in the MooDFOOD depression prevention randomized controlled trial were used'],"['placebos, (b) placebos and food-related behavioral activation therapy (F-BA), (c) multinutrient supplements (fish oil and multivitamin), and (d) multinutrient supplements and F-BA', 'omega-3 (n-3) polyunsaturated fatty acids']","['Baseline PUFA levels', 'n-3 PUFA levels', 'n-3 PUFA, docosahexaenoic acid, and eicosapentaenoic acid levels', 'Change in PUFA levels', 'circulating omega-3 serum levels', 'depressive symptoms', 'PUFA levels (µmol/L', 'Depressive symptoms']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",682.0,0.0952639,"Change in PUFA levels was not significantly associated with the change in depressive symptoms (β = .002, SE = 0.003, p = .39; β = .003, SE = 0.005, p = .64; β = .005, SE = 0.005, p = .29; β = -.0002, SE = 0.0004, p = .69).","[{'ForeName': 'Carisha S', 'Initials': 'CS', 'LastName': 'Thesing', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute de Boelelaan, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Milaneschi', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute de Boelelaan, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute de Boelelaan, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science and the Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, Goethe-Universität Frankfurt, Frankfurt a.M., Germany.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, Idisba, Rediapp, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, Idisba, Rediapp, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science and the Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute de Boelelaan, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Depression and anxiety,['10.1002/da.23092']
2463,32845061,"Machine learning risk score for prediction of gestational diabetes in early pregnancy in Tianjin, China.","AIMS


This study aimed to develop a machine learning-based prediction model for gestational diabetes mellitus (GDM) in early pregnancy in Chinese women.
METHODS


We used an established population-based prospective cohort of 19331 pregnant women registered as pregnant before the 15 th  gestational week in Tianjin, China, from October 2010 to August 2012. The dataset was randomly divided into a training set (70%) and a test set (30%). Risk factors collected at registration were examined and used to construct the prediction model in the training dataset. Machine learning, i.e., the extreme gradient boosting method (XGBoost), was employed to develop the model, while a traditional logistic model was also developed for comparison purposes. In the test dataset, the performance of the developed prediction model was assessed by calibration plots for calibration and area under the receiver operating characteristic curve (AUR) for discrimination.
RESULTS


In total, 1484 (7.6%) women developed GDM. Pre-pregnancy body mass index (BMI), maternal age, fasting plasma glucose at registration, and alanine aminotransferase (ALT) were selected as risk factors. The machine learning XGBoost model-predicted probability of GDM was similar to the observed probability in the test data set, while the logistic model tended to overestimate the risk at the highest risk level (Hosmer-Lemeshow test P value: 0.243 vs 0.099). The XGBoost model achieved a higher AUR than the logistic model (0.742 vs. 0.663, P < 0.001). This XGBoost model was deployed through a free, publicly available software interface (https://liuhongwei.shinyapps.io/gdm_risk_calculator/).
CONCLUSION


The XGBoost model achieved better performance than the logistic model. This article is protected by copyright. All rights reserved.",2020,"The XGBoost model achieved a higher AUR than the logistic model (0.742 vs. 0.663, P < 0.001).","['gestational diabetes mellitus (GDM) in early pregnancy in Chinese women', '19331 pregnant women registered as pregnant before the 15 th  gestational week in Tianjin, China, from October 2010 to August 2012', 'gestational diabetes in early pregnancy in Tianjin, China']","['machine learning-based prediction model', 'Machine learning risk score']","['GDM. Pre-pregnancy body mass index (BMI), maternal age, fasting plasma glucose at registration, and alanine aminotransferase (ALT']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",19331.0,0.0253115,"The XGBoost model achieved a higher AUR than the logistic model (0.742 vs. 0.663, P < 0.001).","[{'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jinnan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Juliana Cn', 'Initials': 'JC', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity and The Chinese University of Hong Kong-Prince of Wales Hospital-International Diabetes Federation Centre of Education, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3397']
2464,32849176,"Technical Features, Feasibility, and Acceptability of Augmented Telerehabilitation in Post-stroke Aphasia-Experiences From a Randomized Controlled Trial.","Background:  Post-stroke aphasia is a communication disorder where existing evidence favors intensive therapy methods. Telerehabilitation represents a service model for geographically remote settings, or other barriers to clinic attendance or to facilitate an augmentation of therapy across a continuum of care. Evidence to support efficiency, feasibility, and acceptability is however still scarce. Appraising aphasia telerehabilitation in controlled trials beyond its effectiveness, by investigating feasibility and acceptability, may facilitate implementation into clinical practice.  Methods:  In our pilot randomized controlled trial, we investigated the feasibility and acceptability of speech and language therapy by videoconference, in addition to usual care, in people with aphasia following stroke. To improve functional, expressive language, a tailored intervention was given 1 h per day, five times per week over four consecutive weeks. Feasibility measures included evaluation of technical setup using diary logs. Acceptability was investigated by examining adherence and satisfaction with therapy alongside evaluation of data safety and privacy.  Results:  Feasibility and acceptability data were collected in relation to 556.5 h of telerehabilitation delivered to 30 participants over a 2-years intervention period by three speech-language pathologists. Protocol adherence was high, with a tolerable technical fault rate; 86 faults were registered over 541 video sessions. Most (80%;  n  = 30) of the participants experienced zero to three faults. The main cause of technical failures was flawed internet connection, causing delayed or interrupted therapy. Total satisfaction with telerehabilitation was rated good or very good by 93.1% ( n  = 29) of participants and two of three speech-language pathologists. Within a moderate variance of technical failure, participants experiencing more faults were more satisfied. No serious events regarding security and privacy were reported. Our model is feasibly and ready to be implemented across a range of clinical settings and contexts.  Conclusions:  Synchronous telerehabilitation for post-stroke aphasia is feasible and acceptable and shows tolerable technical fault rates with high satisfaction among patients and pathologists. Within a low rate of faults, satisfaction was not negatively influenced by fault frequency. Access to clinical and technical expertise is needed when developing telerehabilitation services. Telerehabilitation may be a viable service delivery model for aphasia rehabilitation.  Trial Registration:  ClinicalTrials.gov, ID: NCT02768922.",2020,Total satisfaction with telerehabilitation was rated good or very good by 93.1% ( n  = 29) of participants and two of three speech-language pathologists.,['people with aphasia following stroke'],['speech and language therapy by videoconference'],"['Total satisfaction', 'Acceptability', 'Technical Features, Feasibility, and Acceptability of Augmented Telerehabilitation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}]",,0.222393,Total satisfaction with telerehabilitation was rated good or very good by 93.1% ( n  = 29) of participants and two of three speech-language pathologists.,"[{'ForeName': 'Hege Prag', 'Initials': 'HP', 'LastName': 'Øra', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kirmess', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway.'}, {'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Brady', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, United Kingdom.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Sørli', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway.'}]",Frontiers in neurology,['10.3389/fneur.2020.00671']
2465,32849205,An Acute Bout of Soccer Heading Subtly Alters Neurovascular Coupling Metrics.,"Objective:  The current investigation examined how a bout of soccer heading may impact brain function.  Design:  Semi-randomized crossover cohort.  Setting:  Controlled soccer heading.  Participants:  Seven male soccer players (24.1 ± 1.5 years).  Intervention:  40 successful soccer headers were performed in 20 min (25 m, launch velocity ~80 km/h). X2 xPatch recorded linear and rotational head accelerations during each impact. A contact control "" sham""  condition - ball made body contact, but not by the head; and a no activity time "" control""  condition were also completed.  Main Outcome Measures:  Posterior and middle cerebral artery (PCA and MCA, respectively), cerebral blood velocity (CBV) was recorded during a visual task (neurovascular coupling: NVC) alongside SCAT3 symptoms scores pre/post a controlled bout of soccer heading.  Results:  Cumulative linear and rotational accelerations were 1,574 ± 97.9 g and 313,761 ± 23,966 rads/s 2 , respectively, during heading and changes in SCAT3 symptom number (pre: 2.6 ± 3.0; post: 6.7 ± 6.2,  p  =  0.13 ) and severity (pre: 3.7 ± 3.6, post: 9.4 ± 7.6,  p  =  0.11 ) were unchanged. In the PCA, no NVC differences were observed, including: relative CBV increase (28.0 ± 7.6% , p  =  0.71 ) and total activation (188.7 ± 68.1 cm,  p  =  0.93 ). However, MCA-derived NVC metrics were blunted following heading, demonstrating decreased relative CBV increase (7.8 ± 3.1%,  p  =  0.03 ) and decreased total activation (26.7 ± 45.3 cm,  p  =  0.04 ).  Conclusion:  Although an acute bout of soccer heading did not result in an increase of concussion-like symptoms, there were alterations in NVC responses within the MCA during a visual task. This suggests an acute bout of repetitive soccer heading can alter CBV regulation within the region of the brain associated with the header impacts.",2020,"In the PCA, no NVC differences were observed, including: relative CBV increase (28.0 ± 7.6% , p  =  0.71 ) and total activation (188.7 ± 68.1 cm,  p  =  0.93 ).","['Participants:  Seven male soccer players (24.1 ± 1.5 years', 'Soccer Heading', '40 successful soccer headers']",[],"['visual task (neurovascular coupling: NVC) alongside SCAT3 symptoms scores pre/post a controlled bout of soccer heading', 'Posterior and middle cerebral artery (PCA and MCA, respectively), cerebral blood velocity (CBV', 'NVC responses', 'concussion-like symptoms', 'total activation', 'Cumulative linear and rotational accelerations', 'X2 xPatch recorded linear and rotational head accelerations', 'relative CBV increase']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C4042905', 'cui_str': 'Neurovascular Coupling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0000325', 'cui_str': '20-Methylcholanthrene'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0054917', 'cui_str': 'CBV protocol'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",7.0,0.0985281,"In the PCA, no NVC differences were observed, including: relative CBV increase (28.0 ± 7.6% , p  =  0.71 ) and total activation (188.7 ± 68.1 cm,  p  =  0.93 ).","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Smirl', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Peacock', 'Affiliation': 'Southern Medical Program, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Wright', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Bouliane', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Dierijck', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Burma', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kennefick', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Wallace', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Donkelaar', 'Affiliation': 'Concussion Research Laboratory, University of British Columbia, Kelowna, BC, Canada.'}]",Frontiers in neurology,['10.3389/fneur.2020.00738']
2466,32849209,"Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study.","Introduction:  Severe, often sudden-onset headache is the principal presenting symptoms of aneurysmal subarachnoid hemorrhage (aSAH). We hypothesized that gabapentin would be safe and tolerable for aSAH-induced headaches and would reduce concurrent opioid use.  Methods:  We performed a single-center, double-blind, randomized, placebo-controlled trial (registered at ClinicalTrials.gov; NCT02330094) from November 24, 2014, to June 24, 2017, where aSAH patients received either dose-escalating gabapentin or oral placebo, both alongside a standard of care pain regimen. After 7 days, patients had the option to continue in an open-label period until 14 days after enrollment or until discharge from the intensive care unit. Our primary endpoint was the efficacy of gabapentin in reducing headache numeric pain scores and opioid usage in patients with aSAH compared to the placebo group. We identified 63 potential patients with aSAH for the study. After applying stringent exclusion criteria, 16 eligible patients were enrolled into one of two arms.  Results:  The study ended prematurely after reaching a pre-specified funding period and an unexpected drop in aSAH cases. There was a trend toward lower headache numeric pain scores and opioid use in the gabapentin treated arm; however this was not significantly different. Gabapentin was well tolerated by participants and no adverse effects were reported.  Conclusions:  While there was a trend toward lower pain scores and opioid requirement in the gabapentin group, the study was underpowered to detect a difference. Larger multicenter trials are required to evaluate the efficacy of gabapentin to reduce opioid requirements after aSAH.",2020,There was a trend toward lower headache numeric pain scores and opioid use in the gabapentin treated arm; however this was not significantly different.,"['After Aneurysmal Subarachnoid Hemorrhage', '63 potential patients with aSAH for the study', 'patients with aSAH', '16 eligible patients were enrolled into one of two arms', 'November 24, 2014, to June 24, 2017, where aSAH patients received either', 'Acute Headache and Meningismus']","['Gabapentin', 'dose-escalating gabapentin or oral placebo, both alongside a standard of care pain regimen', 'placebo', 'gabapentin']","['pain scores and opioid requirement', 'Safety, Tolerability, and Efficacy of Pain Reduction', 'headache numeric pain scores and opioid usage', 'headache numeric pain scores']","[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0025287', 'cui_str': 'Meningism'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",16.0,0.48609,There was a trend toward lower headache numeric pain scores and opioid use in the gabapentin treated arm; however this was not significantly different.,"[{'ForeName': 'Laxmi P', 'Initials': 'LP', 'LastName': 'Dhakal', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Marion T', 'Initials': 'MT', 'LastName': 'Turnbull', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Jackson', 'Affiliation': 'Department of Pharmacy, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Edwards', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Hodge', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Neeharika', 'Initials': 'N', 'LastName': 'Thottempudi', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Prasuna', 'Initials': 'P', 'LastName': 'Kamireddi', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Oluwaseun O', 'Initials': 'OO', 'LastName': 'Akinduro', 'Affiliation': 'Department of Neurologic Surgery, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Miller', 'Affiliation': 'Division of Neuroradiology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Freeman', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.00744']
2467,32849212,Clinical and Neurochemical Effects of Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis: A Study Protocol for a Randomized Clinical Trial.,"Background:  Transcranial Magnetic Stimulation (TMS) is a technique based on the principles of electromagnetic induction. It applies pulses of magnetic radiation that penetrate the brain tissue, and it is a non-invasive, painless, and practically innocuous procedure. Previous studies advocate the therapeutic capacity of TMS in several neurodegenerative and psychiatric processes, both in animal models and in human studies. Its uses in Parkinson's disease, Alzheimer's disease and in Huntington's chorea have shown improvement in the symptomatology and in the molecular profile, and even in the cellular density of the brain. Consequently, the extrapolation of these TMS results in the aforementioned neurodegenerative disease to other entities with etiopathogenic and clinical analogy would raise the relevance and feasibility of its use in multiple sclerosis (MS). The overall objective will be to demonstrate the effectiveness of the TMS in terms of safety and clinical improvement, as well as to observe the molecular changes in relation to the treatment.  Methods and Design:  Phase II clinical trial, unicentric, controlled, randomized, single blind. A total of 90 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) who meet all the inclusion criteria and do not present any of the exclusion criteria that are established and from which clinically evaluable results can be obtained. The patients included will be assigned under the 1:1:1 randomization formula, constituting three groups for the present study: 30 patients treated with natalizumab + white (placebo) + 30 patients treated with natalizumab + TMS (1 Hz) + 30 patients treated with natalizumab + TMS (5 Hz).  Discussion:  Results of this study will inform on the efficiency of the TMS for the treatment of MS. The expected results are that TMS is a useful therapeutic resource to improve clinical status (main parameters) and neurochemical profile (surrogate parameters); both types of parameters will be checked.  Ethics and Dissemination:  The study is approved by the Local Ethics Committee and registered in https://clinicaltrials.gov (NCT04062331). Dissemination will include submission to a peer-reviewed journal, patients, associations of sick people and family members, healthcare magazines and congress presentations.  Trial Registration:  ClinicalTrials.gov ID: NCT04062331 (registration date: 19 th / August/2019).  Version Identifier:  EMTr-EMRR, ver-3, 21/11/2017.",2020,The expected results are that TMS is a useful therapeutic resource to improve clinical status (main parameters) and neurochemical profile (surrogate parameters); both types of parameters will be checked.  ,"['Multiple Sclerosis', '90 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS']","['natalizumab + white (placebo) + 30 patients treated with natalizumab + TMS (1 Hz) + 30 patients treated with natalizumab + TMS (5 Hz', 'Transcranial Magnetic Stimulation (TMS', 'TMS']",[],"[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],90.0,0.0882961,The expected results are that TMS is a useful therapeutic resource to improve clinical status (main parameters) and neurochemical profile (surrogate parameters); both types of parameters will be checked.  ,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Agüera', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Caballero-Villarraso', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Feijóo', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Begoña M', 'Initials': 'BM', 'LastName': 'Escribano', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Conde', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Bahamonde', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Giraldo', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Elier', 'Initials': 'E', 'LastName': 'Paz-Rojas', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Túnez', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}]",Frontiers in neurology,['10.3389/fneur.2020.00750']
2468,32849215,Gonadal Steroids and Sperm Quality in a Cohort of Relapsing Remitting Multiple Sclerosis: A Case-Control Study.,"Introduction:  Evaluation of the hypothalamic-pituitary-testicular axis and sperm analyses are not a standard examination of patients with Relapsing-Remitting Multiple Sclerosis (RRMS).  Methods:  This is a prospective-case-controlled study. Patients, aged 18-55, with a confirmed diagnosis of RRMS, naïve to any DMT were enrolled. Controls were men with normal evaluation who acceded to the Andrology Center of Catania in a contemporary matched randomized fashion to the group of RRMS patients. The aim of the study is to evaluate gonadal steroids and sperm quality in men at the time of RRMS diagnosis and 12 months following the first disease modifying treatment (DMT).  Results:  Out of 41 patients with RRMS, 38 were included in the study (age 40.3 ± 12.3) to be compared with matched controls. Patients with RRMS showed no differences in gonadal steroids or sperm parameters, except for free testosterone (fT) plasma levels, which were lower in RRMS patients than controls (median 0.09  vs . 1.4,  p  < 0.0001). The correlation analyses, corrected for age and Body Mass Index, did not reveal any correlation between hormonal/sperm parameters and level of disability or disease activity at onset. Additionally, 12 months following the start of DMT, there were no differences in gonadal steroids and sperm quality compared to baseline.  Conclusions:  Results suggest that RRMS may not have an impact on fertility status but prospective long-term studies are needed.",2020,"Patients with RRMS showed no differences in gonadal steroids or sperm parameters, except for free testosterone (fT) plasma levels, which were lower in RRMS patients than controls (median 0.09  vs .","['41 patients with RRMS, 38 were included in the study (age 40.3 ± 12.3) to be compared with matched controls', 'Controls were men with normal evaluation who acceded to the Andrology Center of Catania in a contemporary matched randomized fashion to the group of RRMS patients', 'patients with Relapsing-Remitting Multiple Sclerosis (RRMS', 'Relapsing Remitting Multiple Sclerosis', 'Patients, aged 18-55, with a confirmed diagnosis of RRMS, naïve to any DMT were enrolled', 'men at the time of RRMS diagnosis and 12 months following the first disease modifying treatment (DMT']","['RRMS', 'Gonadal Steroids and Sperm Quality']","['fertility status', 'gonadal steroids and sperm quality', 'free testosterone (fT) plasma levels', 'gonadal steroids or sperm parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",41.0,0.0189436,"Patients with RRMS showed no differences in gonadal steroids or sperm parameters, except for free testosterone (fT) plasma levels, which were lower in RRMS patients than controls (median 0.09  vs .","[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': ""D'Amico"", 'Affiliation': 'Department ""G.F. Ingrassia"", MS Center, University of Catania, Catania, Italy.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Zanghì', 'Affiliation': 'Department ""G.F. Ingrassia"", MS Center, University of Catania, Catania, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Burgio', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Clara Grazia', 'Initials': 'CG', 'LastName': 'Chisari', 'Affiliation': 'Department ""G.F. Ingrassia"", MS Center, University of Catania, Catania, Italy.'}, {'ForeName': 'Rosita Angela', 'Initials': 'RA', 'LastName': 'Condorelli', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'La Vignera', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Aldo Eugenio', 'Initials': 'AE', 'LastName': 'Calogero', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department ""G.F. Ingrassia"", MS Center, University of Catania, Catania, Italy.'}]",Frontiers in neurology,['10.3389/fneur.2020.00756']
2469,32849903,The Effect of Conduction Exercise and Self-Acupressure in Treatment of Parkinson's Disease: A Pilot Study.,"Introduction


Parkinson's disease cannot be well treated by conventional medication. Acupuncture and Tai Chi are proven to be effective in relieving symptoms of Parkinson's disease. Traditional Chinese medicine exercises may prove to be an effective complementary therapy.
Objective


To evaluate the efficacy and safety of conduction exercise and self-acupressure in treating Parkinson's disease.
Method


This study is an accessor- and data analyzer-blind, add-on, randomized, controlled, pilot clinical study. In the treatment group, they were taught to practice conduction exercise and self-acupressure for 8 weeks. No additional treatment was given in the control group. Assessments were done at week 4 and week 8 of the treatment period. The primary outcomes are the total score and domain scores of the Chinese version of 39-item Parkinson's Disease Questionnaire. The secondary outcomes are the total score and domain scores of a custom-designed questionnaire, which is a short form of Nonmotor Symptom Scale.
Results


22 patients in the treatment group and 14 in the control group continued to the treatment phase. Patients in the treatment group displayed improvement trends in primary and secondary outcomes. Improvements were significant in two areas of a custom-designed questionnaire: total score ( p =0.014) and domain score of gastrointestinal tract ( p =0.004). No severe adverse events were reported.
Conclusion


Conduction exercise and self-acupressure were well accepted by and feasible for Parkinson's disease patients. The data generated can be used for the planning of future studies. The exercise regime can be promoted as a home-based, self-practice therapy for Parkinson's disease patients, due to its safety, low cost, and convenience in implementation. This study is registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-17011987, on 14 July 2017).",2020,Improvements were significant in two areas of a custom-designed questionnaire: total score ( p =0.014) and domain score of gastrointestinal tract ( p =0.004).,"[""Parkinson's disease patients"", ""Parkinson's Disease""]","['Traditional Chinese medicine exercises', 'conduction exercise and self-acupressure', 'Conclusion\n\n\nConduction exercise and self-acupressure', 'practice conduction exercise and self-acupressure', 'Conduction Exercise and Self-Acupressure', 'Acupuncture and Tai Chi']","['severe adverse events', 'total score and domain scores of a custom-designed questionnaire, which is a short form of Nonmotor Symptom Scale', ""total score and domain scores of the Chinese version of 39-item Parkinson's Disease Questionnaire"", 'domain score of gastrointestinal tract']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]",,0.0256179,Improvements were significant in two areas of a custom-designed questionnaire: total score ( p =0.014) and domain score of gastrointestinal tract ( p =0.004).,"[{'ForeName': 'Chun-Sum', 'Initials': 'CS', 'LastName': 'Yuen', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Ka-Kit', 'Initials': 'KK', 'LastName': 'Chua', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Wai-Hing', 'Initials': 'WH', 'LastName': 'Lau', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Zhi-Yuen', 'Initials': 'ZY', 'LastName': 'Zhuang', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Ho-Yan', 'Initials': 'HY', 'LastName': 'Chow', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/7950131']
2470,32849914,Randomized phase II study of valproic acid in combination with bevacizumab and oxaliplatin/fluoropyrimidine regimens in patients with  RAS -mutated metastatic colorectal cancer: the REVOLUTION study protocol.,"Background


Despite effective treatments, metastatic colorectal cancer (mCRC) prognosis is still poor, mostly in  RAS -mutated tumors, thus suggesting the need for novel combinatorial therapies. Epigenetic alterations play an important role in initiation and progression of cancers, including CRC. Histone-deacetylase inhibitors (HDACi) have shown activity in combination with chemotherapy in the treatment of solid tumors. Owing to its HDACi activity and its safe use for epileptic disorders, valproic acid (VPA) is a good candidate for anticancer therapy that we have largely explored preclinically translating our findings in currently ongoing clinical studies. We have shown in CRC models that HDACi, including VPA, induces synergistic antitumor effects in combination with fluoropyrimidines. Furthermore, unpublished results from our group demonstrated that VPA induces differentiation and sensitization of CRC stem cells to oxaliplatin. Moreover, preclinical and clinical data suggest that HDACi may prevent/reverse anti-angiogenic resistance.
Methods/Design


A randomized, open-label, two-arm, multicenter phase-II study will be performed to explore whether the addition of VPA to first line bevacizumab/oxaliplatin/fluoropyrimidine regimens (mFOLFOX-6/mOXXEL) might improve progression-free survival (PFS) in  RAS -mutated mCRC patients. A sample size of 200 patients was calculated under the hypothesis that the addition of VPA to chemotherapy/bevacizumab can improve PFS from 9 to 12 months, with one-sided alpha of 0.20 and a power of 0.80. Secondary endpoints are overall survival, objective response rate, metastases resection rate, toxicity, and quality of life. Moreover, the study will explore several prognostic and predictive biomarkers on blood samples, primary tumors, and on resected metastases.
Discussion


The ""Revolution"" study aims to improve the treatment efficacy of  RAS -mutated mCRC through an attractive strategy evaluating the combination of VPA with standard cancer treatment. Correlative studies could identify novel biomarkers and could add new insight in the mechanism of interaction between VPA, fluoropyrimidine, oxaliplatin, and bevacizumab.
Trial Registration


EudraCT: 2018-001414-15; ClinicalTrials.gov identifier: NCT04310176.",2020,"Secondary endpoints are overall survival, objective response rate, metastases resection rate, toxicity, and quality of life.","['RAS -mutated mCRC patients', '200 patients', 'patients with  RAS -mutated metastatic colorectal cancer']","['bevacizumab/oxaliplatin/fluoropyrimidine regimens (mFOLFOX-6/mOXXEL', 'fluoropyrimidine, oxaliplatin, and bevacizumab', 'valproic acid', 'oxaliplatin', 'bevacizumab and oxaliplatin/fluoropyrimidine regimens', 'VPA to chemotherapy/bevacizumab', 'HDACi', 'Histone-deacetylase inhibitors (HDACi', 'VPA']","['overall survival, objective response rate, metastases resection rate, toxicity, and quality of life', 'progression-free survival (PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1512474', 'cui_str': 'Histone deacetylase inhibitor'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0345748,"Secondary endpoints are overall survival, objective response rate, metastases resection rate, toxicity, and quality of life.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Avallone', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Via M. Semmola, Napoli, 80131, Italy.'}, {'ForeName': 'Maria Carmela', 'Initials': 'MC', 'LastName': 'Piccirillo', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Di Gennaro', 'Affiliation': 'Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Romano', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Calabrese', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Maria Serena', 'Initials': 'MS', 'LastName': 'Roca', 'Affiliation': 'Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Tatangelo', 'Affiliation': 'Pathology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Granata', 'Affiliation': 'Radiology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cassata', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Ernesta', 'Initials': 'E', 'LastName': 'Cavalcanti', 'Affiliation': 'Laboratory Medicine Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maurea', 'Affiliation': 'Cardiology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Piera', 'Initials': 'P', 'LastName': 'Maiolino', 'Affiliation': 'Pharmacy Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Silvestro', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'De Stefano', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giuliani', 'Affiliation': 'Medical Oncology Department, NCI Giovanni Paolo II, Bari, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, S. Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Dipartimento di Oncologia e Cure Palliative, Azienda Ospedaliera Cardinale G. Panico, Tricase-Lecce, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Aprea', 'Affiliation': 'Vascular Access Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Vicario', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nappi', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Vitagliano', 'Affiliation': 'Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Casaretti', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Leone', 'Affiliation': 'Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Petrillo', 'Affiliation': 'Radiology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Botti', 'Affiliation': 'Pathology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Delrio', 'Affiliation': 'Colorectal Oncological Surgery, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Izzo', 'Affiliation': 'Hepatobiliary Surgery Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Budillon', 'Affiliation': 'Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Via M. Semmola, Napoli, 80131, Italy.'}]",Therapeutic advances in medical oncology,['10.1177/1758835920929589']
2471,32849913,Urinary stone management during the COVID-19 pandemic: a suggested approach and review of literature.,"COVID-19 is now the major health concern of the century in many countries. Prolonged homestay has various undesirable consequences for people, such as physical inactivity and weight gain, which potentially could put people at risk of urinary stone formation. With regard to the prevention and treatment strategy for urinary stones during this COVID-19 pandemic period, patients can be divided into two groups. The first group comprises those for whom urological intervention is not indicated and where general dietary and lifestyle recommendations are helpful. The second group comprises those patients where urological intervention is indicated. This group can be divided into emergent and nonemergent subgroups. Patients with urinary stones and concomitant uremia, sepsis, anuria, or refractory pain and vomiting make up the emergent group, where intervention is necessary. The preferred option during the novel coronavirus crisis for these patients is percutaneous nephrostomy tube insertion under local anesthesia. The second subgroup is made up of those patients with asymptomatic and noncomplicated renal and ureteral stones where urologic intervention is indicated in the usual time scale. However, we suggest conservative treatment for 3 months during the COVID-19 outbreak after which re-evaluation of the patient should be carried out. Thus the operation could be chosen carefully based on the patient's and urologist's preference and the rate of infection in that center.",2020,"With regard to the prevention and treatment strategy for urinary stones during this COVID-19 pandemic period, patients can be divided into two groups.","['Patients with urinary stones and concomitant uremia, sepsis, anuria, or refractory pain and vomiting make up the emergent group']",['percutaneous nephrostomy tube insertion under local anesthesia'],['Urinary stone management'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0041948', 'cui_str': 'Uremia'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0003460', 'cui_str': 'Anuria'}, {'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027724', 'cui_str': 'Percutaneous insertion of nephrostomy tube'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",,0.0160182,"With regard to the prevention and treatment strategy for urinary stones during this COVID-19 pandemic period, patients can be divided into two groups.","[{'ForeName': 'Alimohammad', 'Initials': 'A', 'LastName': 'Fakhr Yasseri', 'Affiliation': 'Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohammad Kazem', 'Initials': 'SMK', 'LastName': 'Aghamir', 'Affiliation': 'Urology Research Center, Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue, Tehran 1416753955, Iran.'}]",Therapeutic advances in urology,['10.1177/1756287220939513']
2472,32849933,Percutaneous Vertebroplasty and Facet Blocking for Treating Back Pain Caused by Osteoporotic Vertebral Compression Fracture.,"Methods


Clinical and radiological data of 204 patients were reviewed. The patients were divided into Group A (PVP alone) and Group B (PVP and FB combined therapy) according to treatments. Back pain was evaluated with Visual Analog Scale (VAS) and Oswestry Disability Index (ODI). The operation, fluoroscopic exposure time, and bone cement leakage were recorded. The  χ   2  test, Student's  t -test, and repeated measures analysis of variance were used to compare the differences between the two groups.
Results


There were 125 patients in Group A and 79 patients in Group B. Their baseline characteristics were similar ( P  > 0.05). The mean VAS scores of Group A and Group B were 7.03 and 7.21 at admission, 4.7 and 3.2 at 1 day after operation, 4.0 and 3.0 at 3 months, and 2.2 and 2.2 at 12 months after operation, respectively. The mean ODI scores of Group A and Group B were 30.9 and 29.8 at admission, 17.6 and 17.7 at 3 months, and 10.5 and 10.9 at 12 months after operation, respectively. The mean operation time and fluoroscopic exposure time of Group A (35.6 minutes and 7.2 seconds, respectively) was significantly shorter than that of Group B (45.7 minutes and 11.7 seconds, respectively,  P  < 0.01). The incidence of bone cement leakage and new fractures after operation did not have statistically significant difference between groups.
Conclusion


PVP and FB combined therapy could provide better pain relief than PVP alone in short term after operation in patients with OVCFs associated back pains.",2020,"The incidence of bone cement leakage and new fractures after operation did not have statistically significant difference between groups.
","['patients with OVCFs associated back pains', 'Osteoporotic Vertebral Compression Fracture', '125 patients in Group A and 79 patients in Group B', '204 patients were reviewed']","['PVP alone', 'Percutaneous Vertebroplasty and Facet Blocking', 'Group A (PVP alone) and Group B (PVP and FB combined therapy']","['incidence of bone cement leakage', 'Back pain', 'mean VAS scores', 'mean ODI scores', 'pain relief', 'operation, fluoroscopic exposure time, and bone cement leakage', 'mean operation time and fluoroscopic exposure time', 'Visual Analog Scale (VAS) and Oswestry Disability Index (ODI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",204.0,0.0174873,"The incidence of bone cement leakage and new fractures after operation did not have statistically significant difference between groups.
","[{'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Division of Spine Surgery, Department of Orthopedics, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Division of Spine Surgery, Department of Orthopedics, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Division of Spine Surgery, Department of Orthopedics, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Division of Spine Surgery, Department of Orthopedics, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]",Pain research & management,['10.1155/2020/5825317']
2473,32850280,Effect of muscle strengthening on peripheral facial palsy: A randomized controlled trial.,"OBJECTIVE


To evaluate the effect of muscle strengthening intervention in peripheral facial palsy (PFP).
METHODS


A randomized controlled trial was conducted at five hospitals. Fifty-one subjects with PFP who showed a response of less than 20% on electroneurography (ENoG) were enrolled. Subjects in a muscle-strengthening-intervention group (MS Group) underwent a selective muscle contraction intervention (SMCI). Subjects in another group not receiving muscle strengthening intervention (Non-MS Group). Both groups underwent three interventions: Prohibition of maximum effort movements, Stretching of the affected facial muscles, and Mirror biofeedback therapy. The outcomes were measured by the Sunnybrook Facial Grading System (FGS) at 6 months after onset (primary endpoint) and at 12 months after onset (secondary endpoint). The subjects in the MS Group and Non-MS Group were further divided into subgroups showing ENoG responses of 10% or less and ENoG responses of over 10%, as a sub-analysis.
RESULTS


No significant differences between the MS Group and Non-MS Group at either the primary endpoint or secondary endpoint. Among the subjects in the treatment group with an ENoG response of over 10% at the primary endpoint, the FGS Composite Score and FGS Voluntary Movement score were both significantly higher in the MS Group than in Non-MS Group. Although the MS Group had a significantly lower FGS Resting Symmetry Score, there was no significant difference between the two groups in the FGS Synkinesis Score.
CONCLUSIONS


SMCI improved paralysis in subjects exhibiting an ENoG response of over 10% within the 6 months from onset without any deterioration of synkinesis.",2020,No significant differences between the MS Group and Non-MS Group at either the primary endpoint or secondary endpoint.,"['peripheral facial palsy', 'peripheral facial palsy (PFP', 'Fifty-one subjects with PFP who showed a response of less than 20% on electroneurography (ENoG) were enrolled']","['muscle-strengthening-intervention group (MS Group) underwent a selective muscle contraction intervention (SMCI', 'muscle strengthening intervention', 'muscle strengthening', 'three interventions: Prohibition of maximum effort movements, Stretching of the affected facial muscles, and Mirror biofeedback therapy']","['FGS Resting Symmetry Score', 'FGS Synkinesis Score', 'FGS Composite Score and FGS Voluntary Movement score', 'Sunnybrook Facial Grading System (FGS']","[{'cui': 'C3266178', 'cui_str': 'Peripheral facial palsy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0919612', 'cui_str': 'Electroneurography'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0015460', 'cui_str': 'Facial Muscles'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234362', 'cui_str': 'Synkinesis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",51.0,0.0284008,No significant differences between the MS Group and Non-MS Group at either the primary endpoint or secondary endpoint.,"[{'ForeName': 'Naohito', 'Initials': 'N', 'LastName': 'Morishima', 'Affiliation': 'Department of Rehabilitation, Toyohashi Municipal Hospital.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kamiya', 'Affiliation': 'Department of Rehabilitation, Toyohashi Municipal Hospital.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Department of Rehabilitation, Toyohashi Municipal Hospital.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Morisaka', 'Affiliation': 'Department of Rehabilitation, Toyohashi Municipal Hospital.'}, {'ForeName': 'Tomoji', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Rehabilitation, Toyohashi Municipal Hospital.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': 'Department of Central Rehabilitation Medicine, Osaka Rosai Hospital.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Department of Otolaryngology, Nagoya City East Medical Center.'}]",Physical therapy research,['10.1298/ptr.E10000']
2474,32850281,Effect of self-calf massage on the prevention of deep vein thrombosis after total knee arthroplasty: A randomized clinical trial.,"OBJECTIVE


Deep vein thrombosis (DVT) is a severe complication after total knee arthroplasty (TKA). Performing self-calf massage may decrease the incidence of DVT. The purpose of this study was to investigate whether self-calf massage is effective for preventing DVT after TKA.
METHOD


In all, 165 patients participated in the present study. Patients were randomized to one of two groups: the self-calf massage group or the control group. In the control group, patients started regular physical therapy. In the self-calf massage group, in addition to regular physical therapy, patients were instructed to massage their calf muscles 30 times from the distal to proximal side. This procedure was repeated three times and was completed in 2 mins during the 2 days following TKA. All patients were evaluated for DVT on postoperative day 3 using lower limb vein ultrasonography.
RESULTS


The incidence of DVT was significantly lower in the self-calf massage group than in the control group. Self-calf massage was associated with a lower incidence of DVT, whereas age and female sex were risk factors for DVT.
CONCLUSION


This study showed that the self-calf massage may be beneficial for the prevention of DVT after TKA.",2020,"Self-calf massage was associated with a lower incidence of DVT, whereas age and female sex were risk factors for DVT.
","['total knee arthroplasty (TKA', 'deep vein thrombosis after total knee arthroplasty', '165 patients participated in the present study']","['self-calf massage group or the control group', 'Self-calf massage', 'self-calf massage']",['incidence of DVT'],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",165.0,0.0171218,"Self-calf massage was associated with a lower incidence of DVT, whereas age and female sex were risk factors for DVT.
","[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Oka', 'Affiliation': 'Anshin Hospital.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Wada', 'Affiliation': 'Anshin Hospital.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Nitta', 'Affiliation': 'Anshin Hospital.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Maruno', 'Affiliation': 'Anshin Hospital.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Mizuno', 'Affiliation': 'Anshin Hospital.'}]",Physical therapy research,['10.1298/ptr.E10014']
2475,32850283,Effectiveness of early high-intensity balance training for early home life independence after total knee arthroplasty: a pseudo-randomized controlled trial.,"OBJECTIVE


In Japan, the number of elderly individuals living alone is increasing, leading to an increase in hospital medical expenses attributed to total knee arthroplasty (TKA). Improvement in balance and functional performance is a priority in the early postoperative stages after TKA. However, there are no reports on the effectiveness of balance training (BT) for inpatients in the early postoperative period. Thus, we aimed to evaluate the effectiveness of early high-intensity BT for early home-life independence after TKA.
METHOD


This pseudo-randomized controlled trial included 49 inpatients who underwent TKA and had osteoarthritis. Inpatients were categorized into the BT or typical training (TT) group. The BT program began on post-TKA day 4, with 12-14 sessions between day 7 and 10 (i.e., 1-2 sessions per day). The effect of the intervention was assessed using balance ability as the main outcome. Sub-outcomes included evaluation of motion function. The differences in each variable before and after intervention were compared, including covariance analysis adjusted for age and sex.
RESULTS


The mean (standard deviation) balance ability indexes in the left and right directions were BT, pre 4.5 (0.8) and post 4.4 (0.8); TT, pre 4.8 (0.9) and post 4.4 (0.8), and those in the forward and backward directions were BT, pre 4.7 (1.7) and post 5.1 (2.1); TT, pre 6.3 (2.6) and post 5.9 (2.0). No significant differences were found between the preoperative and postintervention scores in the two groups for any measured outcome.
CONCLUSION


BT did not appear to improve balance ability or functional performance.",2020,"No significant differences were found between the preoperative and postintervention scores in the two groups for any measured outcome.
","['early home life independence after total knee arthroplasty', '49 inpatients who underwent TKA and had osteoarthritis']","['balance training (BT', 'BT or typical training (TT', 'BT', 'early high-intensity balance training']","['evaluation of motion function', 'mean (standard deviation) balance ability indexes', 'balance and functional performance', 'balance ability or functional performance', 'preoperative and postintervention scores']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",49.0,0.067281,"No significant differences were found between the preoperative and postintervention scores in the two groups for any measured outcome.
","[{'ForeName': 'Mutsumi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Tohto University Faculty of Human Care at Makuhari Department of Physical Therapy.'}, {'ForeName': 'Chiyoko', 'Initials': 'C', 'LastName': 'Kise', 'Affiliation': 'Akabane Central General Hospital.'}, {'ForeName': 'Saho', 'Initials': 'S', 'LastName': 'Hasegawa', 'Affiliation': 'Akabane Central General Hospital.'}, {'ForeName': 'Sadaya', 'Initials': 'S', 'LastName': 'Misaki', 'Affiliation': 'Sonodakai Joint Replacement Center Hospital.'}]",Physical therapy research,['10.1298/ptr.E9995']
2476,32850292,"The effect of  ""maviz ˮ on memory improvement in university students: A randomized open-label clinical trial.","Objective


Numerous studies demonstrated the effect of grape on memory improvement. According to Iranian traditional medicine, ""mavizˮ as a specific type of dried grapes can effectively improve memory. However, there is no reported clinical trial on the effect of ""mavizˮ on memory improvement in humans. Hence, this study was conducted to investigate ""mavizˮ effect on memory in university students.
Materials and Methods


This randomized open-label clinical trial was conducted on a total number of 53 students of Shahed University, Tehran, Iran, from November 2017 to February 2018. The participants were randomly allocated into an intervention group (receiving ""mavizˮ, 25 g in the morning for 4 weeks) or a control group (who did not take ""mavizˮ). The Digit Span Task and the N-Back Task were used for the measurement of working memory at the pre- and post-intervention stages.
Results


According to the results, no significant differences were found between the two groups regarding age, gender, marital status, and initial working memory test scores. ""mavizˮ consumption produced a highly significant improvement in total working memory score in the Digit Span Task (5.18 vs. 2.35, p<0.001) and Acoustic Memory Span (1.29 vs. 0.62, p=0.021). Moreover, ""mavizˮ consumption significantly increased the percentage of true responses in the N-Back Task and reduced the mean reaction time in the first level of the task.
Conclusion


""mavizˮ consumption was improved working memory in young healthy adults.",2020,"mavizˮ consumption produced a highly significant improvement in total working memory score in the Digit Span Task (5.18 vs. 2.35, p<0.001) and Acoustic Memory Span (1.29 vs. 0.62, p=0.021).","['young healthy adults', 'total number of 53 students of Shahed University, Tehran, Iran, from November 2017 to February 2018', 'university students']","['intervention group (receiving ""mavizˮ, 25 g in the morning for 4 weeks) or a control group (who did not take ""mavizˮ', 'maviz ˮ']","['Digit Span Task and the N-Back Task', 'total working memory score', 'mean reaction time', 'working memory', 'initial working memory test scores. ', 'percentage of true responses', 'Acoustic Memory Span']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0503555,"mavizˮ consumption produced a highly significant improvement in total working memory score in the Digit Span Task (5.18 vs. 2.35, p<0.001) and Acoustic Memory Span (1.29 vs. 0.62, p=0.021).","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mirheidary', 'Affiliation': 'Department of Iranian Traditional Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Seyyed Saeed', 'Initials': 'SS', 'LastName': 'Esmaeili Saber', 'Affiliation': 'Department of Iranian Traditional Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Shaeiri', 'Affiliation': 'Department of Clinical Psychology, Faculty of Humanities, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Gholami Fesharaki', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University , Tehran, Iran.'}]",Avicenna journal of phytomedicine,[]
2477,32850414,Adding Concurrent Chemotherapy to Intensity-Modulated Radiotherapy Does Not Improve Treatment Outcomes for Stage II Nasopharyngeal Carcinoma: A Phase 2 Multicenter Clinical Trial.,"Purpose:  To explore the efficacy of concomitant chemotherapy in intensity-modulated radiotherapy (IMRT) to treat stage II nasopharyngeal carcinoma (NPC).  Methods and Materials:  In this randomized phase 2 study [registered with ClinicalTrials.gov (NCT01187238)], eligible patients with stage II (2010 UICC/AJCC) NPC were randomly assigned to either IMRT alone (RT group) or IMRT combined with concurrent cisplatin (40 mg/m 2 , weekly) (CCRT group). The primary endpoint was overall survival (OS). The second endpoints included local failure-free survival (LFFS), regional failure-free survival (RFFS), disease-free survival (DFS), distant metastasis-free survival (DMFS), and acute toxicities.  Results:  Between May 2010 to July 2012, 84 patients who met the criteria were randomized to the RT group ( n  = 43) or the CCRT group ( n  = 41). The median follow-up time was 75 months. The OS, LFFS, RFFS, DFS, and DMFS for the RT group and CCRT group were 100% vs. 94.0% ( p  = 0.25), 93.0% vs. 89.3% ( p  = 0.79), 97.7% vs. 95.1% ( p  = 0.54), 90.4% vs. 86.6% ( p  = 0.72), and 95.2% vs. 94.5% ( p  = 0.77), respectively. A total of 14 patients experienced disease failure, 7 patients in each group. The incidence of grade 2 to 4 leukopenia was higher in the CCRT group ( p  = 0.022). No significant differences in liver, renal, skin, or mucosal toxicity was observed between the two groups.  Conclusion:  For patients with stage II NPC, concomitant chemotherapy with IMRT did not improve survival or disease control but had a detrimental effect on bone marrow function.",2020,The incidence of grade 2 to 4 leukopenia was higher in the CCRT group ( p  = 0.022).,"['stage II nasopharyngeal carcinoma (NPC', '14 patients experienced disease failure, 7 patients in each group', 'eligible patients with stage II (2010 UICC/AJCC) NPC', '84 patients who met the criteria', 'Stage II Nasopharyngeal Carcinoma']","['IMRT alone (RT group) or IMRT combined with concurrent cisplatin', 'Concurrent Chemotherapy to Intensity-Modulated Radiotherapy', 'IMRT', 'concomitant chemotherapy in intensity-modulated radiotherapy (IMRT', 'CCRT']","['local failure-free survival (LFFS), regional failure-free survival (RFFS), disease-free survival (DFS), distant metastasis-free survival (DMFS), and acute toxicities', 'overall survival (OS', 'liver, renal, skin, or mucosal toxicity', 'OS, LFFS, RFFS, DFS, and DMFS', 'bone marrow function', 'incidence of grade 2 to 4 leukopenia', 'survival or disease control']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441914', 'cui_str': 'UICC'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3854395', 'cui_str': 'Mucosal toxicity'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.226622,The incidence of grade 2 to 4 leukopenia was higher in the CCRT group ( p  = 0.022).,"[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Province Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Province Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Jin', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Province Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shiping', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianghu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guozhen', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Yi', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01314']
2478,32850507,Effects of Gabapentin Suspension and Rectal Acetaminophen on Postoperative Pain of Adenotonsillectomy in Children.,"Introduction


Adenotonsillectomy is the main treatment for symptomatic tonsillar hypertrophy with postoperative pain as the most common associated complication. The present study aimed to compare the efficacy of gabapentin with that reported for acetaminophen on the postoperative pain of adenotonsillectomy in children.
Materials and Methods


In this double-blind clinical trial, a total of 60 children within the age range of 7-15 years undergoing adenotonsillectomy were randomly allocated to two groups of gabapentin (n=30) and acetaminophen (n=30). The first group received a 10 mg/kg dose of gabapentin suspension preoperatively and placebo (suppository) after the intubation. The second group received a 40 mg/kg dose of acetaminophen suppository and placebo suspension simultaneous with that in the case group. Using the pain scale (based on the score of visual analog scale, prescribed drugs, dosage as well as incidence of postoperative nausea and vomiting were recorded 0, 2, 4, 6, 12, and 24 h after the surgery. The data were analyzed using SPSS software (version 22.0). A p-value less than 0.05 was considered statistically significant.
Results


There was no significant difference between the two groups considering the pain scores at 0, 2, 4, 6, 12, and 24 h after the surgery. In addition, the trend of pain intensity statistically decreased within 0 to 24 h in both acetaminophen (P<0.001) and gabapentin (P<0.001) groups. No statistically significant difference was observed between the two groups regarding the postoperative incidence of nausea and vomiting.
Conclusion


The obtained results of the present study showed that the administration of gabapentin and acetaminophen significantly reduced the postoperative pain of tonsillectomy and need for narcotics in these patients after the surgery. However, in this study, there was no particular reported superiority for any of the two groups in terms of the effects of gabapentin suspension and rectal acetaminophen.",2020,"There was no significant difference between the two groups considering the pain scores at 0, 2, 4, 6, 12, and 24 h after the surgery.","['children', '60 children within the age range of 7-15 years undergoing adenotonsillectomy', 'Children']","['acetaminophen', 'gabapentin suspension preoperatively and placebo (suppository', 'gabapentin suspension and rectal acetaminophen', 'acetaminophen suppository and placebo suspension simultaneous', 'gabapentin', 'gabapentin and acetaminophen', 'Gabapentin Suspension and Rectal Acetaminophen']","['postoperative pain of tonsillectomy and need for narcotics', 'postoperative pain of adenotonsillectomy', 'Postoperative Pain of Adenotonsillectomy', 'postoperative incidence of nausea and vomiting', 'pain scale', 'pain intensity', 'score of visual analog scale, prescribed drugs, dosage as well as incidence of postoperative nausea and vomiting', 'pain scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.19348,"There was no significant difference between the two groups considering the pain scores at 0, 2, 4, 6, 12, and 24 h after the surgery.","[{'ForeName': 'Soudabeh', 'Initials': 'S', 'LastName': 'Haddadi', 'Affiliation': 'Anesthesia Research Center, Department of Anesthesiology, Alzahra Hospital,Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Marzban', 'Affiliation': 'Anesthesia Research Center, Department of Anesthesiology, Alzahra Hospital,Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Parvizi', 'Affiliation': 'Anesthesia Research Center, Department of Anesthesiology, Alzahra Hospital,Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Rhino-Sinus, Ear, and Skull Base Diseases Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Chohdari', 'Affiliation': 'Anesthesiologist, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Atrkar Roshan', 'Affiliation': 'Anesthesia Research Center, Department of Anesthesiology, Alzahra Hospital,Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ramezani', 'Affiliation': 'Rhino-Sinus, Ear, and Skull Base Diseases Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",Iranian journal of otorhinolaryngology,['10.22038/ijorl.2020.38811.2283']
2479,32850508,Peritonsillar Ropivacaine Infiltration in Paediatric Tonsillectomy: A Randomised Control Trial.,"Introduction


Various efforts have been made to reduce post tonsillectomy pain in children. The present study was undertaken to evaluate the efficacy and safety of Ropivacaine in post-operative pain management in these children.
Materials and Methods


This study is a Randomized control study on 140 patients between 4 - 12 years of age, in whom tonsillectomy was performed in a tertiary care centre between January 2017 to November 2018 using standard dissection and snare surgical technique. Postoperatively, patients were randomized into 2 groups of 70 patients each, receiving tonsillar fossa infiltration with 0.2% Ropivacaine or 0.9% normal saline respectively. Patients were assessed as per Wong Baker's Faces Scoring System at 2 hours, 4 hours, 8 hours, 18 hours, 24 hours, and 48 hours postoperatively. All the results were analyzed by SPSS software. Chi- square test and Mann-Whitney test were used for assessment of level of significance, with P- value of less than 0.05 taken as significant.
Results


Both the groups were comparable with respect to age and sex. At 48 hours, in study group, maximum number of patients 35 (50%) had Wong Baker score 0, while in control group, maximum number of patients 52 (74.3%) had Wong Baker score 4 (P< 0.01). The difference in the mean Deglutition time between both groups was significant (P< 0.01).
Conclusion


Ropivacaine infiltration is a effective modality for post-tonsillectomy pain management in children, with minimal side-effects.",2020,"The difference in the mean Deglutition time between both groups was significant (P< 0.01).
","['children', '140 patients between 4 - 12 years of age, in whom tonsillectomy was performed in a tertiary care centre between January 2017 to November 2018 using standard dissection and snare surgical technique', 'Paediatric Tonsillectomy']","['Ropivacaine', 'Peritonsillar Ropivacaine']","['efficacy and safety', 'mean Deglutition time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0183362', 'cui_str': 'Snare'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",140.0,0.0506339,"The difference in the mean Deglutition time between both groups was significant (P< 0.01).
","[{'ForeName': 'Arvinder-Singh', 'Initials': 'AS', 'LastName': 'Sood', 'Affiliation': 'Department of Otorhinolaryngology, SGRD Institute of Medical Sciences and Research, Amritsar, Punjab, India - 143001.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Pal', 'Affiliation': 'Department of Otorhinolaryngology, SGRD Institute of Medical Sciences and Research, Amritsar, Punjab, India - 143001.'}, {'ForeName': 'Gurupreet-Singh', 'Initials': 'GS', 'LastName': 'Gill', 'Affiliation': 'Department of Otorhinolaryngology, SGRD Institute of Medical Sciences and Research, Amritsar, Punjab, India - 143001.'}]",Iranian journal of otorhinolaryngology,['10.22038/ijorl.2020.36577.2199']
2480,32850511,Effect of Vowel Auditory Training on the Speech-In-Noise Perception among Older Adults with Normal Hearing.,"Introduction


Aging reduces the ability to understand speech in noise. Hearing rehabilitation is one of the ways to help older people communicate effectively. This study aimed to investigate the effect of vowel auditory training on the improvement of speech-in-noise (SIN) perception among elderly listeners.
Materials and Methods


This study was conducted on 36 elderly listeners (17 males and 15 females) with the mean±SD of 67.6±6.33. They had the normal peripheral auditory ability but had difficulties in SIN perception. The samples were randomly divided into two groups of intervention and control. The intervention group underwent vowel auditory training; however, the control group received no training.
Results


After vowel auditory training, the intervention group showed significant changes in the results of the SIN test at two signal-to-noise ratios of 0 and -10 and the Iranian version of the Speech, Spatial, and Qualities of Hearing Scale, compared to the control group (P<0.001). Regarding the Speech Auditory Brainstem Response test, the F 0  magnitude was higher in the intervention group (8.42±2.26), compared to the control group (6.68±1.87) (P<0.011).
Conclusion


This study investigated the effect of vowel auditory training on the improvement of SIN perception which could be probably due to better F 0  encoding and receiving. This ability enhancement resulted in the easier perception of speech and its more proper separation from background noise which in turn enhanced the ability of the old people to follow the speech of a specific person and track the discussion.",2020,"Regarding the Speech Auditory Brainstem Response test, the F 0  magnitude was higher in the intervention group (8.42±2.26), compared to the control group (6.68±1.87) (P<0.011).
","['36 elderly listeners (17 males and 15 females) with the mean±SD of 67.6±6.33', 'Older Adults with Normal Hearing', 'elderly listeners']","['Vowel Auditory Training', 'vowel auditory training', 'control group received no training', 'Hearing rehabilitation']","['SIN test at two signal-to-noise ratios of 0 and -10 and the Iranian version of the Speech, Spatial, and Qualities of Hearing Scale', 'normal peripheral auditory ability', 'speech-in-noise (SIN) perception', 'SIN perception']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",36.0,0.0150403,"Regarding the Speech Auditory Brainstem Response test, the F 0  magnitude was higher in the intervention group (8.42±2.26), compared to the control group (6.68±1.87) (P<0.011).
","[{'ForeName': 'Atta', 'Initials': 'A', 'LastName': 'Heidari', 'Affiliation': 'Department of Audiology, Faculty of Rehabilitation, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Moossavi', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Yadegari', 'Affiliation': 'Department of Speech Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ahadi', 'Affiliation': 'Department of Audiology, Rehabilitation Research Center, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of otorhinolaryngology,['10.22038/ijorl.2019.33433.2110']
2481,32850558,Euphrasia Eye Drops in Preterm Neonates With Ocular Discharge: A Randomized Double-Blind Placebo-Controlled Trial.,"Aim:  To investigate whether the early administration of Euphrasia eye drops® in preterm neonates presenting with ocular discharge fosters the resolution of the ocular discharge and reduces the need for topical antibiotic therapy, as compared to placebo.  Methods:  We conducted a randomized double-blind placebo-controlled trial at the University Children's Hospital Bern, Switzerland. Preterm neonates with white, yellow, or green ocular discharge were included. Infants were randomly assigned (1:1) to the Euphrasia arm (Euphrasia eye drops®, Weleda AG, Arlesheim) or the placebo arm (NaCl 0.9%). Euphrasia or placebo was administrated at a dose of one drop in each eye four times a day over a period of 96 h. The primary outcome was the treatment success, defined as no ocular discharge at 96 h and no use of topical antibiotic therapy during the 96-h intervention.  Results:  A total of 114 neonates were screened and 84 were randomized. Among neonates in the Euphrasia arm, 22 (55.0%) achieved our primary outcome compared to 21 (51.2%) in the placebo arm ( p  = 0.85). In the Euphrasia arm, time to resolution of reddening tended to fall within the shorter bracket of 24 to 48 h (24 (92.3%) vs. 12 (80.0%) in the placebo arm,  p  = 0.34) and relapse or first signs of reddening during the 96-h intervention tended to be lower [3 (7.9%) eyes vs. 8 (18.2%) eyes in the placebo arm,  p  = 0.17]. Tearing at 96 h tended to be lower in the Euphrasia arm [5 (12.8%) eyes in the Euphrasia arm vs. 12 (27.3%) eyes in the placebo arm,  p  = 0.10].  Discussion:  Euphrasia did not significantly improve treatment success, defined as no ocular discharge at 96 h and no use of topical antibiotic therapy during the 96-h intervention. However, results suggest that Euphrasia may be of benefit for symptoms such as reddening and tearing, and thus improve the comfort of patients.  Trial Registration:  The trial is registered at the US National Institutes of Health (ClinicalTrials.gov) NCT04122300 and at the portal for human research in Switzerland SNCTP000003490.",2020,"Euphrasia did not significantly improve treatment success, defined as no ocular discharge at 96 h and no use of topical antibiotic therapy during the 96-h intervention.","['preterm neonates presenting with ocular discharge', 'Preterm neonates with white, yellow, or green ocular discharge were included', 'A total of 114 neonates were screened and 84 were randomized', ""University Children's Hospital Bern, Switzerland"", 'Preterm Neonates', 'With Ocular Discharge']","['Euphrasia or placebo', 'Euphrasia eye drops®', 'topical antibiotic therapy', 'Euphrasia arm (Euphrasia eye drops®, Weleda AG, Arlesheim) or the placebo', 'placebo', 'Placebo']","['treatment success, defined as no ocular discharge at 96 h and no use of topical antibiotic therapy', 'relapse or first signs of reddening']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0948288', 'cui_str': 'Conjunctival discharge'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0221205', 'cui_str': 'Yellow color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C1082871', 'cui_str': 'Eyebright'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0948288', 'cui_str': 'Conjunctival discharge'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449990', 'cui_str': 'First sign'}]",114.0,0.742882,"Euphrasia did not significantly improve treatment success, defined as no ocular discharge at 96 h and no use of topical antibiotic therapy during the 96-h intervention.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Meier-Girard', 'Affiliation': 'Anthroposophically Extended Medicine, Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Gerstenberg', 'Affiliation': 'Anthroposophically Extended Medicine, Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Liliane', 'Initials': 'L', 'LastName': 'Stoffel', 'Affiliation': 'Department of Neonatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Kohler', 'Affiliation': 'Department of Neonatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sabine D', 'Initials': 'SD', 'LastName': 'Klein', 'Affiliation': 'Anthroposophically Extended Medicine, Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Eschenmoser', 'Affiliation': 'Department of Pharmacy, Hospital of Freiburg, Freiburg, Switzerland.'}, {'ForeName': 'Vera Ruth', 'Initials': 'VR', 'LastName': 'Mitter', 'Affiliation': 'Department of Obstetrics and Gynecology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Nelle', 'Affiliation': 'Neonatology Division, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Wolf', 'Affiliation': 'Anthroposophically Extended Medicine, Institute of Complementary and Integrative Medicine, University of Bern, Bern, Switzerland.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00449']
2482,32850567,"Effects of the ""Inspirational Lecture"" in Combination With ""Ordinary Antenatal Parental Classes"" as Professional Support for Expectant Parents: A Pilot Study as a Randomized Controlled Trial.","Background:  Both expectant mothers and their partners describe weaknesses in ordinary parental preparatory professional support provided internationally and nationally within Sweden. Therefore, it is necessary to develop the parental preparatory professional support provided by midwives for expectant parents within Sweden. This study will evaluate the effects on expectant parents of receiving a combination of an ""inspirational lecture"" and ""ordinary antenatal parental classes"" compared with only ""ordinary antenatal parental classes.""  Methods/Design:  This block randomized controlled trial included an intervention as a pilot study, in which expectant parents were randomized for (1) the inspirational lecture  and  ordinary antenatal parental classes (intervention group [IG]) ( n  = 66) or (2) ordinary antenatal parental classes (control group [CG]) ( n  = 60). Data collection with repeated questionnaires was conducted in the first week and 6 months after birth. Statistical analyses were conducted for participant characteristics, differences between parents within IG and CG, effects of the intervention, intention to treat, and internal consistency of the included measurements.  Results:  The intervention showed a tendency to be gainful for one out of four outcomes related to birth experience, and parents' perceived quality of parental couple relationship consensus and sexuality and manageability. These results were more prominent for the partners. Parents within both the intervention and control groups reported decreased social support in the first 6 months after birth.  Conclusion and Clinical Implications:  Overall, the concept of the inspirational lecture in combination with ordinary antenatal parental classes as parental preparatory professional support seems to be a valuable care intervention. However, this study was a pilot study and the results should therefore be interpreted with caution. More research is needed since childbirth and transition to parenthood are complex processes in need of comprehension.",2020,"The intervention showed a tendency to be gainful for one out of four outcomes related to birth experience, and parents' perceived quality of parental couple relationship consensus and sexuality and manageability.",['Expectant Parents'],"['Inspirational Lecture"" in Combination With ""Ordinary Antenatal Parental Classes', 'inspirational lecture  and  ordinary antenatal parental classes (intervention group [IG]) ( n  = 66) or (2) ordinary antenatal parental classes (control group [CG', 'inspirational lecture"" and ""ordinary antenatal parental classes"" compared with only ""ordinary antenatal parental classes']","['social support', 'quality of parental couple relationship consensus and sexuality and manageability']","[{'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0537079,"The intervention showed a tendency to be gainful for one out of four outcomes related to birth experience, and parents' perceived quality of parental couple relationship consensus and sexuality and manageability.","[{'ForeName': 'Stina', 'Initials': 'S', 'LastName': 'Thorstensson', 'Affiliation': 'School of Health Sciences, University of Skövde, Skövde, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Ekström-Bergström', 'Affiliation': 'Department of Health Sciences, University West, Trollhättan, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bäckström', 'Affiliation': 'School of Health Sciences, University of Skövde, Skövde, Sweden.'}]",Frontiers in public health,['10.3389/fpubh.2020.00285']
2483,32845087,Implicit and Explicit Anti-Fat Attitude Change Following a Brief Cognitive Dissonance Intervention for Weight Stigma.,"OBJECTIVE


Research has demonstrated that explicit anti-fat attitudes decrease immediately following a brief cognitive dissonance-based intervention targeting weight stigma. The current study explores changes in explicit and implicit anti-fat attitudes immediately following a cognitive dissonance-based weight stigma intervention and 1 week after.
METHODS


College students (N = 156) were randomly assigned to a control or dissonance weight stigma intervention. Weight stigma attitudes were assessed at three time points, and participants completed a measure of values at baseline. Participants in the dissonance condition were told that they had anti-fat attitudes that were inconsistent with their values, whereas participants in the control group were told that their attitudes aligned with their values. All participants reviewed feedback at a follow-up visit before completing explicit and implicit weight stigma assessments a final time.
RESULTS


Individuals in the dissonance condition reported statistically significant decreases in explicit attitudes from Visit 1 to Visit 3. In contrast, there was not a significant condition by time interaction on implicit attitudes.
CONCLUSIONS


This study provides support for cognitive dissonance-based interventions to reduce explicit, but not implicit, anti-fat attitudes following repeated exposure to dissonance induction.",2020,"RESULTS


Individuals in the dissonance condition reported statistically significant decreases in explicit attitudes from Visit 1 to Visit 3.",['College students (N\u2009=\u2009156'],"['control or dissonance weight stigma intervention', 'Implicit and Explicit Anti-Fat Attitude Change Following a Brief Cognitive Dissonance Intervention', 'cognitive dissonance-based weight stigma intervention']","['explicit attitudes', 'Weight stigma attitudes']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0235187', 'cui_str': 'Attitude changed'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",156.0,0.0164691,"RESULTS


Individuals in the dissonance condition reported statistically significant decreases in explicit attitudes from Visit 1 to Visit 3.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Breithaupt', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Trojanowski', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, Virginia, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22909']
2484,32845114,"Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study.","Background: Roflumilast cream (ARQ-151) is a highly potent, selective phosphodiesterase-4 inhibitor in development for once-daily topical treatment of chronic plaque psoriasis. Objectives: To assess the safety and efficacy of once-daily roflumilast cream 0.5% and 0.15% in patients with chronic plaque psoriasis. Methods: This phase 1/2a study enrolled a single-dose, open-label cohort (Cohort 1: 0.5% cream applied to 25 cm² psoriatic plaques), and a 28-day, double-blinded cohort (Cohort 2: 1:1:1 randomization to roflumilast cream 0.5%, 0.15%, or vehicle). Patients had chronic plaque psoriasis of >6 months' duration with ≤5% body surface area involvement. Outcomes included safety (adverse events) and efficacy (percentage change in the Target Plaque Severity Score [TPSS] × Target Plaque Area [TPA]) at week 4. Results: For Cohorts 1 (n=8) and 2 (n=89), adverse events (all mild/moderate; none severe or serious) were similar between active arms and vehicle. Treatment-related events were confined to the application site, without differences between drug and vehicle. No patient discontinued treatment due to adverse events. The primary efficacy endpoint was met for both roflumilast cream doses: TPSS×TPA improvement at week 4 was statistically significant for roflumilast 0.5% (P=0.0007) and 0.15% (P=0.0011) versus vehicle; significance was reached as early as 2 weeks. For both roflumilast cream doses, 66%-67% improvement from baseline was observed at week 4, without reaching a plateau, versus 38% improvement for vehicle. Conclusion: Roflumilast cream was safe and highly effective at doses of 0.5% and 0.15% and represents a potential novel once-daily topical therapy for the treatment of chronic plaque psoriasis. ClinicalTrials.gov NCT03392168. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5370.",2020,Roflumilast cream was safe and highly effective at doses of 0.5% and 0.15% and represents a potential novel once-daily topical therapy for the treatment of chronic plaque psoriasis.,"['patients with chronic plaque psoriasis', ""Patients had chronic plaque psoriasis of >6 months' duration with ≤5% body surface area involvement""]","['Roflumilast Cream', ': Roflumilast cream (ARQ-151', 'roflumilast cream', 'once-daily roflumilast cream', 'Roflumilast cream']","['safety (adverse events) and efficacy (percentage change in the Target Plaque Severity Score [TPSS] × Target Plaque Area [TPA', 'severe or serious', 'safety and efficacy', 'adverse events', 'Signs and Symptoms of Plaque Psoriasis', 'roflumilast cream doses: TPSS×TPA improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.176384,Roflumilast cream was safe and highly effective at doses of 0.5% and 0.15% and represents a potential novel once-daily topical therapy for the treatment of chronic plaque psoriasis.,"[{'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': ''}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Droege', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Merritt', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Osborne', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Berk', 'Affiliation': ''}, {'ForeName': 'Archie W', 'Initials': 'AW', 'LastName': 'Thurston', 'Affiliation': ''}, {'ForeName': 'Valerie H', 'Initials': 'VH', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Welgus', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5370']
2485,32845223,Safety and Efficacy of Using Staplers and Vessel Sealing Devices for Laparoscopic Splenectomy: A Randomized Controlled Trial.,"Background.  Laparoscopic splenectomy (LS) is considered the operation of choice on elective basis for managing patients with certain hematological disorders. Hemostatic control of the splenic pedicle is one of the crucial steps in LS. This study compares the safety and efficacy of using endoscopic staplers and vessel sealing devices to control the splenic pedicle in patients with nonsevere splenomegaly.  Methods.  Fifty-one consecutive patients with different blood disorders including idiopathic thrombocytopenic purpura (ITP), hypersplenism, and lymphoma were randomized for elective LS. Traditional steps of LS, via lateral approach, were followed, and pedicle control was done with either endovascular gastrointestinal anastomosis stapler (n = 26) or vessel sealing device (Ligasure) (n = 25).  Results.  No difference was noted with different splenic spans when using either methods of pedicle control ( P  = .145). The volume of blood loss was higher in the Ligasure group compared to the staplers group (182 mL vs 131 mL, respectively), but was not statistically significant ( P  = .249). Conversion to open was notably higher in the Ligasure group ( P  = .034), but the intraoperative complications were comparable in both groups ( P  = .357).  Conclusion.  The use of vessel sealing devices for splenic pedicle control has comparable surgical outcomes compared with the use of endoscopic staplers for LS, but with higher rate of conversion to open surgery.",2020,"Conversion to open was notably higher in the Ligasure group ( P  = .034), but the intraoperative complications were comparable in both groups ( P  = .357).  ","['Laparoscopic Splenectomy', 'patients with nonsevere splenomegaly', 'Fifty-one consecutive patients with different blood disorders including idiopathic thrombocytopenic purpura (ITP), hypersplenism, and lymphoma', 'patients with certain hematological disorders']","['endovascular gastrointestinal anastomosis stapler (n = 26) or vessel sealing device (Ligasure', 'Staplers and Vessel Sealing Devices', 'Laparoscopic splenectomy (LS', 'endoscopic staplers and vessel sealing devices']","['intraoperative complications', 'Safety and Efficacy', 'safety and efficacy', 'volume of blood loss']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038002', 'cui_str': 'Splenomegaly'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0020532', 'cui_str': 'Hypersplenism'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0205423', 'cui_str': 'Certain'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C3874013', 'cui_str': 'Endoscopic stapler'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",51.0,0.0783226,"Conversion to open was notably higher in the Ligasure group ( P  = .034), but the intraoperative complications were comparable in both groups ( P  = .357).  ","[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Elmoatasembellah', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Senbel', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'Shahatto', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Eldamshety', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Mosab', 'Initials': 'M', 'LastName': 'Shetiwy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdel Wahab', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Abouzid', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Setit', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}]",Surgical innovation,['10.1177/1553350620953023']
2486,32845243,Motion-Based Technology for People With Dementia Training at Home: Three-Phase Pilot Study Assessing Feasibility and Efficacy.,"BACKGROUND


Persons with dementia tend to be vulnerable to mobility challenges and hence face a greater risk of fall and subsequent fractures, morbidity, and mortality. Motion-based technologies (MBTs), also called sensor-based technologies or virtual reality, have the potential for assisting physical exercise and training as a part of a disease management and rehabilitation program, but little is known about its' use for people with dementia.
OBJECTIVE


The purpose of this pilot study was to investigate the feasibility and efficacy of MBT physical training at home for people with dementia.
METHODS


A 3-phase pilot study: (1) baseline start-up, (2) 15 weeks of group training at a local care center twice a week, and (3) 12 weeks of group training reduced to once a week, supplemented with individual MBT training twice a week at home. A total of 26 people with dementia from a municipality in Southern Denmark were eligible and agreed to participate in this study. Three withdrew from the study, leaving 23 participants for the final analysis. Feasibility was measured by the percentage of participants who trained with MBT at home, and their completion rate of total scheduled MBT sessions. Efficacy was evaluated by physical function, measured by Sit-to-Stand (STS), Timed-Up-and-Go (TUG), 6-minute Walk Test (6MW), and 10-meter Dual-task Walking Test (10MDW); cognitive function was measured by Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory-Questionnaire (NPI-Q); and European Quality of Life 5 dimensions questionnaire (EQOL5) was used for measuring quality of life. Descriptive statistics were applied accordingly. Wilcoxon signed-rank and rank-sum tests were applied to explore significant differences within and between the groups.
RESULTS


As much as 12 of 23 participants (52%) used the supplemental MBT training at home. Among them, 6 (50%) completed 75% or more scheduled sessions, 3 completed 25% or less, and 3 completed between 25% and 75% of scheduled sessions. For physical and cognitive function tests, supplementing with MBT training at home showed a tendency of overall stabilization of scores among the group of participants who actively trained with MBT; especially, the 10MDW test even showed a significant improvement from 9.2 to 7.1 seconds (P=.03). We found no positive effect on EQOL5 tests.
CONCLUSIONS


More than half of the study population with dementia used MBT training at home, and among them, half had an overall high adherence to the home training activity. Physical function tended to remain stable or even improved among high-adherence MBT individuals. We conclude that MBT training at home may be feasible for some individuals with dementia. Further research is warranted.",2020,"For physical and cognitive function tests, supplementing with MBT training at home showed a tendency of overall stabilization of scores among the group of participants who actively trained with MBT; especially, the 10MDW test even showed a significant improvement from 9.2 to 7.1 seconds (P=.03).","['people with dementia', 'People With Dementia Training at Home', 'Persons with dementia', '26 people with dementia from a municipality in Southern Denmark were eligible and agreed to participate in this study']","['Motion-based technologies (MBTs', 'MBT physical training', 'supplemental MBT training', 'MBT training', 'individual MBT training', 'Motion-Based Technology']","['physical function, measured by Sit-to-Stand (STS), Timed-Up-and-Go (TUG), 6-minute Walk Test (6MW), and 10-meter Dual-task Walking Test (10MDW); cognitive function was measured by Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory-Questionnaire (NPI-Q); and European Quality of Life 5 dimensions questionnaire (EQOL5', 'overall stabilization of scores', 'Feasibility', 'Efficacy', 'Physical function', 'quality of life', 'EQOL5 tests']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",26.0,0.0208469,"For physical and cognitive function tests, supplementing with MBT training at home showed a tendency of overall stabilization of scores among the group of participants who actively trained with MBT; especially, the 10MDW test even showed a significant improvement from 9.2 to 7.1 seconds (P=.03).","[{'ForeName': 'Jindong Ding', 'Initials': 'JD', 'LastName': 'Petersen', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Eva Ladekjær', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Diagnostic Centre, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'la Cour', 'Affiliation': 'REHPA, The Danish Knowledge Center for Rehabilitation and Palliative Care, Odense University Hospital & University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'von Bülow', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Skouboe', 'Affiliation': 'Dementia Knowledge Center, Esbjerg Municipality, Esbjerg, Denmark.'}, {'ForeName': 'Jeanette Reffstrup', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}]",JMIR mental health,['10.2196/19495']
2487,32845283,Efficacy of Telmisartan to Slow Growth of Small Abdominal Aortic Aneurysms: A Randomized Clinical Trial.,"Importance


Currently there is no drug therapy for abdominal aortic aneurysm (AAA).
Objective


To test the efficacy of the angiotensin receptor blocker telmisartan in slowing AAA growth in the Telmisartan in the Management of Abdominal Aortic Aneurysm (TEDY) trial.
Design, Setting, and Participants


A randomized, double-blind, placebo-controlled trial recruited participants between September 6, 2011, and October 5, 2016, to evaluate the efficacy of telmisartan treatment in patients with AAA. Participants with 35- to 49-mm AAAs recruited from Australia, the Netherlands, and the US were randomized 1:1 to receive telmisartan, 40 mg, or identical placebo. Analyses were conducted according to intention-to-treat principles. Final follow-up was conducted on October 11, 2018, and data analysis was performed between June and November 2019.
Intervention


Telmisartan, 40 mg, or identical placebo.
Main Outcomes and Measures


The primary outcome of the difference in AAA growth, assessed on core imaging laboratory-read ultrasonographic scanning, was tested with linear mixed-effects models. Other outcomes included effects on blood pressure, computed tomographic (CT)-measured AAA diameter and volume, time to AAA-related events (AAA repair or mortality due to AAA rupture), and health-related quality of life.
Results


Of 300 intended participants, 210 were enrolled and randomized to receive telmisartan (n = 107) or placebo (n = 103). Of patients included in the intention-to-treat analysis (telmisartan: n = 106, placebo: n = 101), 183 were men (88%); mean (SD) age was 73.5 (7.9) years. At 1 year, participants receiving telmisartan had mean lower systolic (8.9; 95% CI, 4.1-13.8 mm Hg; P < .001) and diastolic (7.0; 4.3-9.8 mm Hg; P < .001) blood pressure levels compared with participants receiving placebo. A total of 188 participants (91%) received at least 2 ultrasonographic scans and 133 participants (64%) had at least 2 CT scans. There was no significant difference in ultrasonographic-assessed AAA growth rates among those assigned telmisartan (1.68 mm/y) or placebo (1.78 mm/y): mean difference, -0.11 mm/y (95% CI, -0.60 to 0.38 mm/y; P = .66). Telmisartan had no significant effects on AAA growth assessed by CT-measured AAA diameter (mean difference, -0.01 mm/y; 95% CI, -0.02 to 0.01 mm/y; P = .23) or volume (mean difference, -0.02 cm3/y; 95% CI, -0.04 to 0.00 cm3/y; P = .11), AAA-related events (relative risk, 1.35; 95% CI, 0.54-3.35; P = .52), or health-related quality of life (mean difference in physical component score at 24 months, 0.4; 95% CI, 0.4-0.4; P = .80). Hypotensive symptoms (eg, syncope) were twice as common among participants receiving telmisartan compared with placebo (28 [26%] vs 13 [13%]; P = .02), but overall adverse event rates were otherwise similar for both groups.
Conclusions and Relevance


This underpowered study did not show a treatment effect for telmisartan on small AAA growth. Future trials will need to ensure adequate sample size and duration of follow-up.
Trial Registrations


anzctr.org.au Identifier: ACTRN12611000931976; ClinicalTrials.gov Identifier: NCT01683084.",2020,"Hypotensive symptoms (eg, syncope) were twice as common among participants receiving telmisartan compared with placebo (28 [26%] vs 13 [13%];","['Small Abdominal Aortic Aneurysms', '188 participants (91%) received at least 2 ultrasonographic scans and 133 participants (64%) had at least 2 CT scans', 'controlled trial recruited participants between September 6, 2011, and October 5, 2016', 'treatment in patients with AAA', 'Of patients included in the intention-to-treat analysis (telmisartan: n\u2009=\u2009106, placebo: n\u2009=\u2009101), 183 were men (88%); mean (SD) age was 73.5 (7.9) years', 'Participants with 35- to 49-mm AAAs recruited from Australia, the Netherlands, and the US']","['angiotensin receptor blocker telmisartan', 'Telmisartan, 40 mg, or identical placebo', 'placebo', 'Telmisartan', 'telmisartan', 'telmisartan, 40 mg, or identical placebo']","['mean lower systolic', 'health-related quality of life', 'blood pressure, computed tomographic (CT)-measured AAA diameter and volume, time to AAA-related events (AAA repair or mortality due to AAA rupture), and health-related quality of life', 'ultrasonographic-assessed AAA growth rates', 'overall adverse event rates', 'AAA growth, assessed on core imaging laboratory-read ultrasonographic scanning', 'Hypotensive symptoms (eg, syncope', 'diastolic', 'AAA growth assessed by CT-measured AAA diameter', 'blood pressure levels']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271742', 'cui_str': 'Glucocorticoid deficiency with achalasia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0741152', 'cui_str': 'Repair of aneurysm of abdominal aorta'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",188.0,0.776737,"Hypotensive symptoms (eg, syncope) were twice as common among participants receiving telmisartan compared with placebo (28 [26%] vs 13 [13%];","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Pinchbeck', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Tomee', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Rowbotham', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Tejas P', 'Initials': 'TP', 'LastName': 'Singh', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Moxon', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Jenkins', 'Affiliation': ""Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Lindeman', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Dalman', 'Affiliation': 'Department of Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'McDonnell', 'Affiliation': 'Department of Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fitridge', 'Affiliation': 'Discipline of Surgery, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Dylan R', 'Initials': 'DR', 'LastName': 'Morris', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.3524']
2488,32845312,Association of Culprit Lesion Location With Outcomes of Culprit-Lesion-Only vs Immediate Multivessel Percutaneous Coronary Intervention in Cardiogenic Shock: A Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Myocardial infarction with a culprit lesion located in the left main or proximal left anterior descending artery compared with other coronary segments is associated with more myocardium at risk and worse clinical outcomes.
Objective


To evaluate the association of culprit lesion location with outcomes of culprit-lesion-only percutaneous coronary intervention with optional staged revascularization vs immediate multivessel percutaneous coronary intervention in patients with multivessel disease, myocardial infarction, and cardiogenic shock.
Design, Setting, and Participants


Post hoc analysis of the Culprit Lesion Only Coronary Intervention vs Multivessel Coronary Intervention in Cardiogenic Shock (CULPRIT-SHOCK), an investigator-initiated randomized, open-label clinical trial. Patients with multivessel disease, acute myocardial infarction, and cardiogenic shock were enrolled at 83 European centers from April 2013 through April 2017.
Interventions


Patients were randomized to culprit-lesion-only percutaneous coronary intervention with optional staged revascularization or immediate multivessel percutaneous coronary intervention (1:1). For this analysis, patients were stratified by culprit lesion location in the left main or proximal left anterior descending artery group and other-culprit-lesion location group.
Main Outcomes and Measures


End points included a composite of death or kidney replacement therapy at 30 days and death at 1 year.
Results


The median age of the study population was 70 (interquartile range, 60-78 years) and 524 of the study participants were men (76.4%). Of the 685 patients, 33.4% constituted the left main or proximal left anterior descending artery group and 66.6% the other-culprit-lesion location group. The left main or proximal left anterior descending artery group had worse outcomes compared with the other-culprit-lesion location group (56.8% vs 47.5%; P = .02 for the composite end point at 30 days and 59.8% vs 50.1%; P = .02 for death at 1 year). In both groups, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a reduced risk of the composite end point at 30 days (49.1% vs 64.3% and 44.1% vs 50.9%; P for interaction = .27). At 1 year, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a significantly reduced risk of death in the left main or proximal left anterior descending artery but not the other-culprit-lesion location group (50.0% vs 69.6%; P = .003 and 49.8% vs 50.4%; P = .89; P for interaction = 0.02).
Conclusions and Relevance


In patients with multivessel disease with myocardial infarction and cardiogenic shock, a culprit lesion located in the left main or proximal left anterior descending artery vs other coronary segments was associated with worse outcomes. These patients may especially benefit from culprit-lesion-only percutaneous coronary intervention with optional staged revascularization, although further investigation is needed to confirm this finding.
Trial Registration


ClinicalTrials.gov Identifier: NCT01927549.",2020,The left main or proximal left anterior descending artery group had worse outcomes compared with the other-culprit-lesion location group (56.8% vs 47.5%; P = .02 for the composite end point at 30 days and 59.8% vs 50.1%; P = .02 for death at 1 year).,"['The median age of the study population was 70 (interquartile range, 60-78 years) and 524 of the study participants were men (76.4', 'Patients with multivessel disease, acute myocardial infarction, and cardiogenic shock were enrolled at 83 European centers from April 2013 through April 2017', 'Cardiogenic Shock', 'patients with multivessel disease, myocardial infarction, and cardiogenic shock', 'patients were stratified by culprit lesion location in the left main or proximal left anterior descending artery group and other-culprit-lesion location group', 'patients with multivessel disease with myocardial infarction and cardiogenic shock']","['culprit-lesion-only percutaneous coronary intervention with optional staged revascularization vs immediate multivessel percutaneous coronary intervention', 'culprit-lesion-only percutaneous coronary intervention with optional staged revascularization or immediate multivessel percutaneous coronary intervention (1:1', 'Multivessel Percutaneous Coronary Intervention', 'Culprit Lesion Only Coronary Intervention vs Multivessel Coronary Intervention']","['risk of death', 'composite of death or kidney replacement therapy at 30 days and death at 1 year']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0862525,The left main or proximal left anterior descending artery group had worse outcomes compared with the other-culprit-lesion location group (56.8% vs 47.5%; P = .02 for the composite end point at 30 days and 59.8% vs 50.1%; P = .02 for death at 1 year).,"[{'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Farhan', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Vogel', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Sorbonne Université Paris 6, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthelemy', 'Affiliation': 'ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Sorbonne Université Paris 6, Paris, France.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck, Luebeck, Germany.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Maier', 'Affiliation': 'Department of Cardiology, Pneumology, and Intensive Care, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'University Medical Centre Mannheim, First Department of Medicine, Faculty of Medicine, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Department of Internal Medicine/Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck, Luebeck, Germany.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Sorbonne Université Paris 6, Paris, France.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Wilhelminenspital, Department of Cardiology, Vienna, Austria.'}]",JAMA cardiology,['10.1001/jamacardio.2020.3377']
2489,32845317,Large Simple Double-Blind Randomized Trials for the Rapid Assessment of the Effectiveness of COVID-19 Vaccines.,,2020,,[],['COVID-19 Vaccines'],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.478567,,"[{'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology, University of Munich, Munich, Germany.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa456']
2490,32845328,Comparative Effectiveness of Community-Based vs Clinic-Based Healthy Choices Motivational Intervention to Improve Health Behaviors Among Youth Living With HIV: A Randomized Clinical Trial.,"Importance


Youth living with HIV make up one-quarter of new infections and have high rates of risk behaviors but are significantly understudied. Effectiveness trials in real-world settings are needed to inform program delivery.
Objective


To compare the effectiveness of the Healthy Choices intervention delivered in a home or community setting vs a medical clinic.
Design, Setting, and Participants


This randomized clinical trial was conducted from November 1, 2014, to January 31, 2018, with 52 weeks of follow-up. Participants, recruited from 5 adolescent HIV clinics in the United States, were youths and young adults living with HIV aged 16 to 24 years who were fluent in English, were currently prescribed HIV medication, had a detectable viral load, and had used alcohol in the past 12 weeks. Individuals with an active psychosis that resulted in an inability to complete questionnaires were excluded. Data were analyzed from May to December, 2019.
Interventions


Participants were randomized to receive the Healthy Choices intervention in either a home or clinic setting. Four 30-minute individual sessions based on motivational interviewing to improve (1) medication adherence and (2) drinking behavior were delivered during 10 weeks by trained community health workers. In session 1, participants chose which behavior to discuss first. Using motivational interviewing strategies, the community health worker elicited motivational language, guided the development of an individualized change plan while supporting autonomy, delivered feedback, and addressed knowledge gaps. Session 2 focused on the second target behavior. In subsequent sessions, community health workers reviewed the individualized change plan, monitored progress, guided problem solving, and helped maintain changes made.
Main Outcomes and Measures


Primary outcomes were viral load and alcohol use change trajectories during 52 weeks of follow-up. Alcohol use severity and frequency were measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (scores range from 0 to 33, with higher scores indicating greater severity of alcohol-related problems) and number of drinks consumed each day over a 30-day period, with timeline followback.
Results


A total of 183 young people living with HIV (145 male [79.2%]; mean [SD] age, 21.4 [1.9] y) were randomized to the home setting (n = 90) or clinical setting (n = 93). Using growth-curve analysis, both groups showed declines in viral load after the intervention: among participants with available viral load information, in the home group, 12 participants (21%) had an undetectable viral load at 16 weeks, 12 (22%) at 28 weeks, and 10 (20%) at 52 weeks; in the clinic group, 16 participants (24%) had an undetectable viral load at 16 weeks, 20 (39%) at 28 weeks, and 18 (35%) at 52 weeks. However, the clinic group maintained gains, whereas those counseled at home had a significantly different and increasing trajectory during follow-up (unstandardized β = -0.07; 95% CI,-0.14 to -0.01; P = .02). A similar pattern was observed in ASSIST scores during follow-up, with reduced ASSIST scores in the clinic group (unstandardized β = -0.44; 95% CI,-0.81 to -0.07; P = .02).
Conclusions and Relevance


In this trial, the Healthy Choices intervention resulted in improvements in viral load and alcohol use over 12 months. Unexpectedly, the clinic setting outperformed home-based delivery for viral suppression. Although cross-sectional differences in ASSIST scores were nonsignificant, clinic delivery did improve the trajectory of ASSIST scores during follow-up. Thus, clinics may be the more effective site for interventions aimed at viral load reduction for young people living with HIV.
Trial Registration


ClinicalTrials.gov Identifier: NCT01969461.",2020,"Using growth-curve analysis, both groups showed declines in viral load after the intervention: among participants with available viral load information, in the home group, 12 participants (21%) had an undetectable viral load at 16 weeks, 12 (22%) at 28 weeks, and 10 (20%) at 52 weeks; in the clinic group, 16 participants (24%) had an undetectable viral load at 16 weeks, 20 (39%) at 28 weeks, and 18 (35%) at 52 weeks.","['November 1, 2014, to January 31, 2018, with 52 weeks of follow-up', 'Participants, recruited from 5 adolescent HIV clinics in the United States, were youths and young adults living with HIV aged 16 to 24 years who were fluent in English, were currently prescribed HIV medication, had a detectable viral load, and had used alcohol in the past 12 weeks', '183 young people living with HIV (145 male [79.2%]; mean [SD] age, 21.4 [1.9', 'Youth Living', 'Individuals with an active psychosis', 'young people living with HIV']","['Healthy Choices intervention', 'HIV', 'motivational interviewing to improve (1) medication adherence and (2) drinking behavior', 'Community-Based vs Clinic-Based Healthy Choices Motivational Intervention']","['viral load', 'trajectory of ASSIST scores', 'viral load and alcohol use change trajectories', 'ASSIST scores', 'viral load and alcohol use', 'undetectable viral load', 'Health Behaviors']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",183.0,0.109012,"Using growth-curve analysis, both groups showed declines in viral load after the intervention: among participants with available viral load information, in the home group, 12 participants (21%) had an undetectable viral load at 16 weeks, 12 (22%) at 28 weeks, and 10 (20%) at 52 weeks; in the clinic group, 16 participants (24%) had an undetectable viral load at 16 weeks, 20 (39%) at 28 weeks, and 18 (35%) at 52 weeks.","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Center for Translational Behavioral Science, Florida State University College of Medicine, Tallahassee.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robles', 'Affiliation': 'School of Social Work, Rutgers University, New Brunswick, New Jersey.'}, {'ForeName': 'Karen Kolmodin', 'Initials': 'KK', 'LastName': 'MacDonell', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Dinaj-Koci', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'College of Health Professions, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Phebe', 'Initials': 'P', 'LastName': 'Lam', 'Affiliation': 'University of Windsor, Faculty of Arts, Humanities and Social Sciences, Windsor, Ontario, Canada.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, Teaneck, New Jersey.'}, {'ForeName': 'K Marie', 'Initials': 'KM', 'LastName': 'Sizemore', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, New York.'}, {'ForeName': 'Tyrel J', 'Initials': 'TJ', 'LastName': 'Starks', 'Affiliation': 'Health Psychology and Clinical Science Program, The Graduate Center, City University of New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.14650']
2491,32845371,Accommodation changes after strabismus surgery due to anterior ciliary vessel disruption.,"PURPOSE


To evaluate monocular accommodation changes after strabismus surgery with and without anterior ciliary vessel preservation.
METHODS


Sixty patients with horizontal concomitant strabismus who were scheduled to undergo monocular strabismus surgeries were randomly divided into two groups: A (without anterior ciliary vessel preservation) and B (with anterior ciliary vessel preservation). Group A was further divided into groups A1 (surgical eyes without anterior ciliary vessel preservation) and A2 (corresponding nonsurgical eyes). Group B was further divided into groups B1 (surgical eyes with anterior ciliary vessel preservation) and B2 (corresponding nonsurgical eyes). Monocular accommodative amplitude (AA) and accommodative facility (AF) were evaluated before and 1 day after the surgery to assess accommodation.
RESULTS


In groups A2, B1, and B2, the AA and AF values showed no significant difference preoperatively or postoperatively. However, compared with preoperative values, both the postoperative AA and AF values were significantly reduced in group A1.
CONCLUSION


Strabismus surgery without anterior ciliary vessel preservation reduces monocular accommodation, whereas strabismus surgery with anterior ciliary vessel preservation protects accommodation.",2020,"In groups A2, B1, and B2, the AA and AF values showed no significant difference preoperatively or postoperatively.",['Sixty patients with horizontal concomitant strabismus who were scheduled to undergo monocular strabismus surgeries'],"['Strabismus surgery without anterior ciliary vessel preservation', 'A (without anterior ciliary vessel preservation) and B (with anterior ciliary vessel preservation', 'strabismus surgery with and without anterior ciliary vessel preservation']","['postoperative AA and AF values', 'Monocular accommodative amplitude (AA) and accommodative facility (AF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0152203', 'cui_str': 'Constant squint'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}]","[{'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0132511,"In groups A2, B1, and B2, the AA and AF values showed no significant difference preoperatively or postoperatively.","[{'ForeName': 'Renyi', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China. wangyan7143@vip.sina.com.'}, {'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Pan', 'Affiliation': 'Xiamen Eye Centre of Xiamen University, Xiamen, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Xiamen Eye Centre of Xiamen University, Xiamen, China.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04905-3']
2492,32845388,Nomogram based on radiomics analysis of primary breast cancer ultrasound images: prediction of axillary lymph node tumor burden in patients.,"OBJECTIVES


To establish a prediction model for evaluating the axillary lymph node (ALN) status of patients with T1/T2 invasive breast cancer based on radiomics analysis of US images of primary breast lesions.
METHODS


Between August 2016 and November 2018, a total of 343 patients with histologically proven malignant breast tumors were included in this study and randomly assigned to the training and validation groups at a ratio of 7:3. ALN tumor burden was defined as low (< 3 metastatic ALNs) or high (≥ 3 metastatic ALNs). Radiomics features were obtained using the PyRadiomics package, and the radiomics score was established by least absolute shrinkage and selection operator regression. A nomogram combining the breast cancer US radiomics score with patient age and lesion size was generated based on the multivariate logistic regression results.
RESULTS


In the training and validation cohorts, 29.1% (69/237) and 32.08% (34/106) of patients were pathologically diagnosed with more than 2 metastatic ALNs, respectively. The radiomics score consisted of 16 US features, and patient age and lesion diameter identified by US were included to construct the model. The AUC of the model was 0.846 (95% CI, 0.790-0.902) for the training cohort and 0.733 (95% CI, 0.613-0.852) for the validation cohort. The calibration curves showed good agreement between the predictions and observations.
CONCLUSIONS


Our novel nomogram demonstrates high accuracy in predicting ALN tumor burden in breast cancer patients. We also suggest further development of PyRadiomics to improve US radiomics.
KEY POINTS


• A nomogram based on US was developed to predict ALN tumor burden (low, < 3 metastatic ALNs; high, ≥ 3 metastatic ALNs). • The nomogram could assist clinicians in evaluating treatment strategies for T1/T2 invasive breast cancer.",2020,ALN tumor burden was defined as low (< 3 metastatic ALNs) or high (≥ 3 metastatic ALNs).,"['patients with T1/T2 invasive breast cancer based on radiomics analysis of US images of primary breast lesions', 'T1/T2 invasive breast cancer', 'patients', 'Between August 2016 and November 2018, a total of 343 patients with histologically proven malignant breast tumors', 'breast cancer patients']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0567489', 'cui_str': 'Lesion of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],[],343.0,0.0327149,ALN tumor burden was defined as low (< 3 metastatic ALNs) or high (≥ 3 metastatic ALNs).,"[{'ForeName': 'Yuanjing', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Mengsu', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Qingli', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China. zqlpumch@126.com.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China. yuxinjiangxh@163.com.'}]",European radiology,['10.1007/s00330-020-07181-1']
2493,32843292,"Validation of ""patient-reported outcomes via online questionnaire"" as a urinary continence assessment and quality improvement tool following radical prostatectomy.","BACKGROUND


Securing reliable data on functional outcomes following radical prostatectomy (RP) is paramount to patient follow-up and management.
OBJECTIVE


To validate an email-based patient-reported outcomes tracking system in assessing pad-free continence rates and time-to continence recovery following RP.
PATIENTS AND METHODS


483 men undergoing RP by a single surgeon from November 2013 to March 2019 were prospectively assigned to 1 of 3 tracking systems: 1) a preaddressed paper packet containing a pad-free card and daily urinary pad log, (N = 249); 2) an automated email questionnaire, (N = 234) or 3) both (N = 51). Patients tracked electronically received electronic Research Electronic Data Capture surveys 30 days after catheter removal, with up to 3 reminders sent automatically if no response was received within 2 days. Response rates and continence rates were compared in group 1 vs. group 2 via student t-tests; time-to pad-free status was assessed for concordance among men in group 3 via linear regression.
RESULTS


Thirty-day response rates in group 1 (paper) vs. group 2 (electronic) were 80.7% (201/249) and 94.0% (220/234), (P < 0.0001); pad-free rates were 64.2% (129/201) and 64.1% (141/220), (P = 0.9847), respectively. Similarly, 1-year response rates in group 1 and 2 were 87.6% (218/249) vs. 94.0% (220/234), (P = 0.0146); pad-free rates were 91.7% (200/218) vs. 96.4% (212/220), (P = 0.0411), respectively. In group 3, time to pad-free continence recovery assessed via Patient Reported Outcomes via Online Questionnaire (PROVOQ) was highly concordant in 89.6% (43/48) of patients ± 5 days (Figure 1, R 2  = 0.9893). No significant bias was found for subsequent reporting in either group.
CONCLUSION


The use of automated email survey questionnaires via PROVOQ for the assessment of patient-reported post-RP continence recovery facilitates increased response rates, timeliness of response, and accuracy. PROVOQ significantly reduce the labor of tracking continence outcomes, improve quality improvement efforts, and enables surgeons to more clearly differentiates risk of long-term incontinence.",2020,"RESULTS


Thirty-day response rates in group 1 (paper) vs. group 2 (electronic) were 80.7% (201/249) and 94.0% (220/234), (P < 0.0001); pad-free rates were 64.2% (129/201) and 64.1% (141/220), (P = 0.9847), respectively.","['483 men undergoing RP by a single surgeon from November 2013 to March 2019', 'radical prostatectomy']","['radical prostatectomy (RP', 'preaddressed paper packet containing a pad-free card and daily urinary pad log, (N\u202f=\u202f249); 2) an automated email questionnaire', 'online questionnaire']","['1-year response rates', 'Response rates and continence rates', 'response rates, timeliness of response, and accuracy', 'pad-free rates', 'time to pad-free continence recovery assessed via Patient Reported Outcomes via Online Questionnaire (PROVOQ']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",483.0,0.11321,"RESULTS


Thirty-day response rates in group 1 (paper) vs. group 2 (electronic) were 80.7% (201/249) and 94.0% (220/234), (P < 0.0001); pad-free rates were 64.2% (129/201) and 64.1% (141/220), (P = 0.9847), respectively.","[{'ForeName': 'Linda My', 'Initials': 'LM', 'LastName': 'Huynh', 'Affiliation': 'Department of Urology, University of California, Irvine Medical Center; Orange, CA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'Department of Urology, University of California, Irvine Medical Center; Orange, CA.'}, {'ForeName': 'Kaelyn', 'Initials': 'K', 'LastName': 'See', 'Affiliation': 'Department of Urology, University of California, Irvine Medical Center; Orange, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jaime', 'Affiliation': 'Department of Urology, University of California, Irvine Medical Center; Orange, CA.'}, {'ForeName': 'Huang Wei', 'Initials': 'HW', 'LastName': 'Su', 'Affiliation': 'Department of Urology, University of California, Irvine Medical Center; Orange, CA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Ahlering', 'Affiliation': 'Department of Urology, University of California, Irvine Medical Center; Orange, CA. Electronic address: tahlerin@uci.edu.'}]",Urologic oncology,['10.1016/j.urolonc.2020.07.001']
2494,32843299,Effect of repetitive transcranial magnetic stimulation on the cognitive impairment induced by sleep deprivation: a randomized trial.,"OBJECTIVE


Currently, an efficient method for improving cognitive impairment due to sleep deprivation (SD) is lacking. The aim of this study is to evaluate the effect of high-frequency repetitive transcranial magnetic stimulation (rTMS) during SD on reversing the adverse effects of SD.
METHODS


A total of 66 healthy people were randomized into the rTMS group and sham group. Both groups were deprived of sleep for 24 h. During SD, participants were asked to complete several cognitive tasks and underwent mood assessments. Saliva cortisol levels, plasma concentrations of brain-derived neurotrophic factor (BDNF), precursor BDNF (proBDNF), and tissue-type plasminogen activator (tPA), and frontal blood activation were detected before and after SD. The rTMS group received real rTMS stimulation for 2 sessions of 10 Hz rTMS (40 trains of 50 pulses with a 20-second intertrain interval) to the left dorsolateral prefrontal cortex and the sham group received sham stimulation during SD.
RESULTS


Twenty-four hours of SD induced a reduced accuracy in the n-back task, increases in both anxiety and depression, increased cortisol levels, decreased frontal blood activation and decreased BDNF levels in healthy people. Notably, rTMS improved the hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation induced by SD, and reduced the consumption of plasma proBDNF.
CONCLUSIONS


Twenty-four hours of SD induced a cognitive impairment. The administration of high-frequency rTMS during sleep deprivation exerted positive effects on HPA axis and frontal activation and might help alleviate cognitive impairment in the long term.",2020,"Notably, rTMS improved the hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation induced by SD, and reduced the consumption of plasma proBDNF.
","['cognitive impairment induced by sleep deprivation', '66 healthy people']","['real rTMS stimulation', 'high-frequency repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation']","['hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation', 'HPA axis and frontal activation', 'consumption of plasma proBDNF', 'cognitive impairment', 'Saliva cortisol levels, plasma concentrations of brain-derived neurotrophic factor (BDNF), precursor BDNF (proBDNF), and tissue-type plasminogen activator (tPA), and frontal blood activation', 'anxiety and depression, increased cortisol levels, decreased frontal blood activation and decreased BDNF levels']","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032144', 'cui_str': 'Plasminogen activator'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1295655', 'cui_str': 'Increased cortisol level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.06412,"Notably, rTMS improved the hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation induced by SD, and reduced the consumption of plasma proBDNF.
","[{'ForeName': 'Shangda', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Hetong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yueran', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Lyu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Mou', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Gongde', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China; Brain Research Institute of Zhejiang University, Hangzhou, China; Zhejiang Engineering Center for Mathematical Mental Health, Hangzhou, China. Electronic address: xuyizju@zju.edu.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.06.019']
2495,32843306,Embryo Ranking Intelligent Classification Algorithm (ERICA): artificial intelligence clinical assistant predicting embryo ploidy and implantation.,"RESEARCH QUESTION


Can a deep machine learning artificial intelligence algorithm predict ploidy and implantation in a known data set of static blastocyst images, and how does its performance compare against chance and experienced embryologists?
DESIGN


A database of blastocyst images with known outcome was applied with an algorithm dubbed ERICA (Embryo Ranking Intelligent Classification Algorithm). It was evaluated against its ability to predict euploidy, compare ploidy prediction against randomly assigned prognosis labels and against senior embryologists, and if it could rank an euploid embryo highly.
RESULTS


A total of 1231 embryo images were classed as good prognosis if euploid and implanted or poor prognosis if aneuploid and failed to implant. An accuracy of 0.70 was obtained with ERICA, with positive predictive value of 0.79 for predicting euploidy. ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively). ERICA ranked an euploid blastocyst first in 78.9% and at least one euploid embryo within the top two blastocysts in 94.7% of cases, better than random classification and the two senior embryologists. Average embryo ranking time for four blastocysts was under 25 s.
CONCLUSION


Artificial intelligence lends itself well to image pattern recognition. We have trained ERICA to rank embryos based on ploidy and implantation potential using single static embryo image. This tool represents a potentially significant advantage to assist embryologists to choose the best embryo, saving time spent annotating and does not require time lapse or invasive biopsy. Future work should be directed to evaluate reproducibility in different data sets.",2020,"ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively).",[],[],['Average embryo ranking time'],[],[],"[{'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",1231.0,0.0681082,"ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Chavez-Badiola', 'Affiliation': 'New Hope Fertility Center Mexico. Av. Prado Norte 135, Lomas de Chapultepec, Miguel Hidalgo, Mexico City, Mexico CP 11000; IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK. Electronic address: acb@EmbryoRanking.com.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Flores-Saiffe-Farías', 'Affiliation': 'New Hope Fertility Center Mexico. Av. Prado Norte 135, Lomas de Chapultepec, Miguel Hidalgo, Mexico City, Mexico CP 11000; IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Mendizabal-Ruiz', 'Affiliation': 'Department of Computational Sciences, Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Drakeley', 'Affiliation': ""IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK; Hewitt Fertility Centre, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK; ART Institute of Washington, Bethesda Maryland, USA; IVFqc, 1185 Sixth Avenue, New York New York, USA.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.07.003']
2496,32843320,Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia.,"BACKGROUND AND AIM


The goal was to evaluate the moderators of mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) to improve dyspareunia, reduce pain catastrophizing, and improve overall sexual function in women with provoked vestibulodynia (PVD). Both treatments effectively reduced self-reported pain, sexual dysfunction, and pain catastrophizing in women with PVD.
METHODS


A total of 130 women with PVD were assigned to CBT or MBCT.
OUTCOMES


Potential moderators included (i) PVD subtype (primary or secondary), (ii) baseline pain intensity, (iii) trait mindfulness, (iv) treatment credibility, (v) relationship duration, and (vi) age. Outcomes were pain intensity, sexual function, and pain catastrophizing at 4 time points: before and after treatment and 6- and 12-month follow-up. Moderation was tested using multilevel models, nesting 4 time points within participants. The interaction of the moderator, time effect, and treatment group was evaluated for significance, and a simple slope analysis of significant interactions was performed.
RESULTS


Pain reduction across 4 time points was the greatest in women who were younger, in relationships of shorter duration, and with greater baseline pain. Treatment credibility moderated pain intensity outcomes (B = 0.305, P < .01) where those with higher treatment credibility ratings (for that particular treatment) improved more in MBCT than CBT. PVD subtype moderated pain catastrophizing (B = 3.150, P < .05). Those with primary PVD improved more in the CBT condition, whereas women with secondary PVD improved more in the MBCT condition. Relationship length moderated sexual function (B = 0.195, P < .01). Women in shorter relationships improved more with MBCT, whereas women in longer relationships improved more on sexual function with CBT. No other tested variables moderated outcomes differentially across both treatment conditions.
CLINICAL IMPLICATIONS


Women who present with high credibility about mindfulness, in shorter relationships, and with secondary PVD might respond better to MBCT whereas those with primary PVD and longer relationships might respond better to CBT.
STRENGTHS & LIMITATIONS


Clinical sample. Half the women who were not sexually active were omitted from analyses of sexual function.
CONCLUSION


Overall, treatment credibility, relationship length, and PVD subtype were found to moderate improvements differently in MBCT and CBT. These findings may assist clinicians in individualizing psychological treatment for women with PVD.
CLINICAL TRIAL REGISTRATION


This clinical trial was registered with clinicaltrials.gov, NCT01704456. Brotto LA, Zdaniuk B, Rietchel L, et al. Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia. J Sex Med 2020;XX:XXX-XXX.",2020,"Overall, treatment credibility, relationship length, and PVD subtype were found to moderate improvements differently in MBCT and CBT.","['women with PVD', 'women with provoked vestibulodynia (PVD', '130 women with PVD']","['Based vs Traditional Cognitive Behavioral Therapy', 'MBCT', 'mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT']","['credibility ratings', 'pain intensity, sexual function, and pain catastrophizing', 'Potential moderators included (i) PVD subtype (primary or secondary), (ii) baseline pain intensity, (iii) trait mindfulness, (iv) treatment credibility, (v) relationship duration, and (vi) age', 'PVD subtype moderated pain catastrophizing', 'Relationship length moderated sexual function', 'pain intensity outcomes', 'Overall, treatment credibility, relationship length, and PVD subtype', 'Pain reduction', 'self-reported pain, sexual dysfunction, and pain catastrophizing', 'overall sexual function', 'sexual function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]",130.0,0.0643955,"Overall, treatment credibility, relationship length, and PVD subtype were found to moderate improvements differently in MBCT and CBT.","[{'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Brotto', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, BC, Canada. Electronic address: Lori.Brotto@vch.ca.'}, {'ForeName': 'Bozena', 'Initials': 'B', 'LastName': 'Zdaniuk', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Rietchel', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Basson', 'Affiliation': 'Department of Psychiatry, University of British Columbia, VGH Blusson Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, Universite de Montreal, Montreal, QC, Canada.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.07.080']
2497,32843370,Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement: A Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVES


We assessed safety and efficacy of another somatostatin receptor analog, pasireotide long-acting release, in severe polycystic liver disease and autosomal dominant polycystic kidney disease. Pasireotide long-acting release, with its broader binding profile and higher affinity to known somatostatin receptors, has potential for greater efficacy.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo. Primary outcome was change in total liver volume; secondary outcomes were change in total kidney volume, eGFR, and quality of life.
RESULTS


Of 48 subjects randomized, 41 completed total liver volume measurements ( n =29 pasireotide long-acting release and  n =12 placebo). From baseline, there were -99±189 ml/m absolute and -3%±7% change in annualized change in height-adjusted total liver volume (from 2582±1381 to 2479±1317 ml/m) in the pasireotide long-acting release group compared with 136±117 ml/m absolute and 6%±7% increase (from 2387±759 to 2533±770 ml/m) in placebo ( P <0.001 for both). Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21 ml/m and 4%±5% increase in the placebo group ( P =0.05 for both). Changes in eGFR were similar between groups. Among the  n =48 randomized, adverse events included hyperglycemia (26 of 33 [79%] in pasireotide long-acting release versus four of 15 [27%] in the placebo group;  P <0.001), and among the 47 without diabetes at baseline, 19 of 32 (59%) in the pasireotide long-acting release group versus one of 15 (7%) in the placebo group developed diabetes ( P =0.001).
CONCLUSIONS


Another somatostatin analog, pasireotide long-acting release, slowed progressive increase in both total liver volume/total kidney volume growth rates without affecting GFR decline. Participants experienced higher frequency of adverse events (hyperglycemia and diabetes).
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Pasireotide LAR in Severe Polycystic Liver Disease, NCT01670110 PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_08_25_CJN13661119.mp3.",2020,Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21,"['48 subjects randomized, 41 completed total liver volume measurements ( n =29 pasireotide long-acting release and  n =12', 'Individuals with severe polycystic liver disease', 'severe polycystic liver disease and autosomal dominant polycystic kidney disease', 'Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement']","['placebo', 'pasireotide long-acting release or placebo']","['Total kidney volumes', 'total kidney volume, eGFR, and quality of life', 'height-adjusted total liver volume', 'hyperglycemia', 'pasireotide long-acting release', 'change in total liver volume', 'frequency of adverse events (hyperglycemia and diabetes', 'Changes in eGFR']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0158683', 'cui_str': 'Congenital cystic disease of liver'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",48.0,0.527677,Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21,"[{'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Hogan', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota hogan.marie@mayo.edu.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Chamberlin', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Vaughan', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Waits', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Leistikow', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Oftsie', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Chuck', 'Initials': 'C', 'LastName': 'Madsen', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glockner', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kremers', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Harris', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Vicente E', 'Initials': 'VE', 'LastName': 'Torres', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Tatyana V', 'Initials': 'TV', 'LastName': 'Masyuk', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13661119']
2498,32851108,Physical Performance Improves With Time and a Functional Knee Brace in Athletes After ACL Reconstruction.,"Background


Athletes who return to sport (RTS) after anterior cruciate ligament reconstruction (ACLR) often have reduced physical performance and a high reinjury rate. Additionally, it is currently unclear how physical performance measures can change during the RTS transition and with the use of a functional knee brace.
Purpose/Hypothesis


The purpose of this study was to examine the effects of time since surgery (at RTS and 3 months after RTS) and of wearing a brace on physical performance in patients who have undergone ACLR. We hypothesized that physical performance measures would improve with time and would not be affected by brace condition.
Study Design


Controlled laboratory study.
Methods


A total of 28 patients who underwent ACLR (9 males, 19 females) completed physical performance testing both after being released for RTS and 3 months later. Physical performance tests included the modified agility  t  test (MAT) and vertical jump height, which were completed with and without a knee brace. A repeated-measures analysis of variance determined the effect of time and bracing on performance measures.
Results


The impact of the knee brace was different at the 2 time points for the MAT side shuffle ( P  = .047). Wearing a functional knee brace did not affect any other physical performance measure. MAT times improved for total time ( P  < .001) and backpedal ( P  < .001), and vertical jump height increased ( P  = .002) in the 3 months after RTS.
Conclusion


The present study showed that physical performance measures of agility and vertical jump height improved in the first 3 months after RTS. This study also showed that wearing a knee brace did not hinder physical performance.
Clinical Relevance


Wearing a functional knee brace does not affect physical performance, and therefore a brace could be worn during the RTS transition without concern. Additionally, physical performance measures may still improve 3 months past traditional RTS, therefore justifying delayed RTS.",2020,"MAT times improved for total time ( P  < .001) and backpedal ( P  < .001), and vertical jump height increased ( P  = .002) in the 3 months after RTS.
","['Athletes', '28 patients who underwent ACLR (9 males, 19 females) completed physical performance testing both after being released for RTS and 3 months later', 'patients who have undergone ACLR', '\n\n\nAthletes who return to sport (RTS) after anterior cruciate ligament reconstruction (ACLR']",[],"['total time', 'modified agility  t  test (MAT) and vertical jump height', 'agility and vertical jump height', 'vertical jump height', 'Physical Performance Improves With Time and a Functional Knee Brace']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]",28.0,0.0313351,"MAT times improved for total time ( P  < .001) and backpedal ( P  < .001), and vertical jump height increased ( P  = .002) in the 3 months after RTS.
","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Dickerson', 'Affiliation': 'Kevin P. Granata Biomechanics Lab, Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg, Virginia, USA.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Peebles', 'Affiliation': 'Kevin P. Granata Biomechanics Lab, Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg, Virginia, USA.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Moskal', 'Affiliation': 'Department of Orthopaedic Surgery, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Miller', 'Affiliation': 'Department of Orthopaedic Surgery, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Queen', 'Affiliation': 'Kevin P. Granata Biomechanics Lab, Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg, Virginia, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120944255']
2499,32851148,Patients' Experiences of Nurse Case-Managed Osteoporosis Care: A Qualitative Study.,"Background


Osteoporosis is a chronic condition that is often left untreated. Nurse case-managers can double rates of appropriate treatment in those with new fractures. However, little is known about patients' experiences of a nurse case-managed approach to osteoporosis care.
Objective


Our aim was to describe patients' experiences of nurse case-managed osteoporosis care.
Methods


A qualitative, descriptive design was used. We recruited patients enrolled in a randomized controlled trial of a nurse case-management approach. Individual semi-structured interviews were conducted which were transcribed and analyzed using content analysis. Data were managed with ATLAS.ti version 7.
Results


We interviewed 15 female case-managed patients. Most (60%) were 60-years or older, 27% had previous fracture, 80% had low bone mineral density tests, and 87% had good osteoporosis knowledge. Three major themes emerged from our analysis: acceptable information to inform decision-making; reasonable and accessible care provided; and appropriate information to meet patient needs.
Conclusions


This study provides important insights about older female patients' experiences with nurse case-managed care for osteoporosis. Our findings suggest that this model to osteoporosis clinical care should be sustained and expanded in this setting, if proven effective. In addition, our findings point to the importance of applying patient-centered care across all dimensions of quality to better enhance the patients' experience of their health care.",2020,Nurse case-managers can double rates of appropriate treatment in those with new fractures.,"[""Patients' Experiences of Nurse Case-Managed Osteoporosis Care"", '15 female case-managed patients', ""patients' experiences of nurse case-managed osteoporosis care"", ""older female patients' experiences with nurse case-managed care for osteoporosis""]",['nurse case-management approach'],"['low bone mineral density tests', 'good osteoporosis knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.023518,Nurse case-managers can double rates of appropriate treatment in those with new fractures.,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Rowe', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Ingstrup', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Finlay A', 'Initials': 'FA', 'LastName': 'McAlister', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Bellerose', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Deceased on January 19, 2018.'}]",Journal of patient experience,['10.1177/2374373519827340']
2500,32851257,Low-dose versus high-dose methylprednisolone for children with severe  Mycoplasma pneumoniae  pneumonia (MCMP): Study protocol for a randomized controlled trial.,"Background


Severe  Mycoplasma pneumoniae  pneumonia (MPP) may develop with long-term pulmonary outcomes despite treatment with macrolides. Combined treatment with glucocorticoids can improve this outcome, though the optimal dosage is unknown. The aim of this study was to investigate the effects of low- and high-dose methylprednisolone in reducing the percentage of long-term pulmonary outcomes for children with severe MPP.
Methods


A randomized, single-blind, parallel-controlled, multicenter clinical trial, methylprednisolone for children with severe  M. pneumoniae  pneumonia (MCMP), is being conducted in China. Pediatric patients (≤18 years of age, expected number = 402) admitted to the hospital with a clinical diagnosis of severe MPP and fulfilling inclusion and exclusion criteria are randomized (ratio of 1:1) to either a low-dose (2 mg/kg/d) or high-dose (10 mg/kg/d) methylprednisolone treatment group for 3 days followed by tapering of methylprednisolone over 12 days and combined with azithromycin. The primary composite outcome will be incidence of atelectasis, bronchiectasis, or bronchiolitis obliterans at 6-months after treatment. Secondary outcomes include recovery time of patient temperature, proportion of pulmonary lesions absorbed, changes of mucosa identified by bronchoscopy, length of hospital stay, pulmonary function and number of participant(s) needing intensive care. Assessments will be made at baseline, post-treatment and at 1-month, 3-month and 6-month follow-ups.
Discussion


This is the first randomized clinical trial designed to evaluate the safety and efficacy of low- versus high-dose methylprednisolone for reducing long-term pulmonary outcomes in pediatric patients with severe MPP. The results of this study will provide scientific evidence to guide clinical practice for the treatment of severe MPP. Trial registration: This study is registered at ClinicalTrials.gov (NCT02303587).",2018,"The primary composite outcome will be incidence of atelectasis, bronchiectasis, or bronchiolitis obliterans at 6-months after treatment.","['pediatric patients with severe MPP', 'children with severe MPP', 'children with severe  M. pneumoniae  pneumonia ', 'Pediatric patients (≤18 years of age, expected number = 402) admitted to the hospital with a clinical diagnosis of severe MPP and fulfilling inclusion and exclusion criteria', 'children with severe  Mycoplasma pneumoniae  pneumonia (MCMP']","['glucocorticoids', 'azithromycin', 'methylprednisolone', 'low- versus high-dose methylprednisolone', 'MCMP', 'low- and high-dose methylprednisolone', 'Low-dose versus high-dose methylprednisolone']","['safety and efficacy', 'incidence of atelectasis, bronchiectasis, or bronchiolitis obliterans', 'recovery time of patient temperature, proportion of pulmonary lesions absorbed, changes of mucosa identified by bronchoscopy, length of hospital stay, pulmonary function and number of participant(s) needing intensive care']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032302', 'cui_str': 'Mycoplasma pneumonia'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0006272', 'cui_str': 'Obliterative bronchiolitis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",402.0,0.222098,"The primary composite outcome will be incidence of atelectasis, bronchiectasis, or bronchiolitis obliterans at 6-months after treatment.","[{'ForeName': 'Baoping', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""Center for Clinical Epidemiology & Evidence-based Medicine Beijing Children's Hospital, Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Lanqin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Adong', 'Initials': 'A', 'LastName': 'Shen', 'Affiliation': ""Beijing Key Laboratory of Pediatric Respiratory Infection Diseases Beijing Pediatric Research Institute Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}, {'ForeName': 'Kunling', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': ""China National Clinical Research Center for Respiratory Diseases Department of Respiratory Medicine Beijing Children's Hospital Capital Medical University, National Center for Children's Health Beijing China.""}]",Pediatric investigation,['10.1002/ped4.12041']
2501,32851338,Effects of dexmedetomidine on the expression of inflammatory factors in children with congenital heart disease undergoing intraoperative cardiopulmonary bypass: a randomized controlled trial.,"Importance


Dexmedetomidine inhibits the inflammatory response associated with cardiopulmonary bypass (CPB) and protects neural function. However, the mechanism of dexmedetomidine's anti-inflammatory pathway is unclear.
Objective


To investigate the effect of dexmedetomidine on the cognitive level and expression of inflammatory factors in children with congenital heart disease undergoing intraoperative CPB.
Methods


Ninety children with congenital heart disease were recruited and randomly divided into 3 groups of 30 children in each. In Group 1, a 1.0 µg·kg -1 ·h -1  intravenous bolus of dexmedetomidine was administered 10 minutes after induction of anesthesia, followed by a 0.2 µg·kg -1 ·h -1  infusion until the surgical incision. In Group 2, a 0.5 µg/kg intravenous bolus of dexmedetomidine was administered 10 minutes after induction of anesthesia, followed by a 0.1 µg·kg -1 ·h -1  infusion until the surgical incision. The control group was given physiological saline using the same method as in Groups 1 and 2. The serum levels of nuclear factor-kappa B (NF-κB), S-100β protein, neuron-specific enolase (NSE), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) were measured before the surgery (T1), at the end of CPB (T2), 2 hours after CPB (T3), 6 hours after CPB (T4), and 24 hours after CPB (T5). The Wechsler Intelligence Scale for children (WISC) was measured before the operation and at 3, 6, and 12 months after the operation to evaluate the neurodevelopmental state of the children.
Results


The levels of the NF-κB, S-100β protein, NSE, TNF-α, IL-6 were significantly higher at T2, T3, or T4 than before the surgery (T1) in the control group or the dexmedetomidine groups. However, the increases of NF-κB, TNF-α, IL-6, S-100β and NSE levels were significantly smaller in the dexmedetomidine groups than those in the control group ( P <  0.017). The WISC scores were similar among the three groups before or after the operation.
Interpretation


The increases in NF-κB, TNF-α, and IL-6 levels indicated aggravation of the inflammatory reaction and the increase S-100β protein and NSE levels indicated that the nervous system was damaged. Administration of dexmedetomidine to children with congenital heart disease undergoing intraoperative CPB can inhibit the inflammatory response and may ameliorate the neurodevelopmental damage caused by CPB.",2020,"The levels of the NF-κB, S-100β protein, NSE, TNF-α, IL-6 were significantly higher at T2, T3, or T4 than before the surgery (T1) in the control group or the dexmedetomidine groups.","['children with congenital heart disease undergoing intraoperative CPB', 'Ninety children with congenital heart disease', 'children with congenital heart disease undergoing intraoperative cardiopulmonary bypass', 'children with congenital heart disease undergoing']","['intraoperative CPB', 'Dexmedetomidine', 'physiological saline', 'dexmedetomidine', 'cardiopulmonary bypass (CPB']","['Wechsler Intelligence Scale for children (WISC', 'levels of the NF-κB, S-100β protein, NSE, TNF-α, IL-6', 'expression of inflammatory factors', 'WISC scores', 'cognitive level and expression of inflammatory factors', 'serum levels of nuclear factor-kappa B (NF-κB), S-100β protein, neuron-specific enolase (NSE), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6', 'NF-κB, TNF-α, IL-6, S-100β and NSE levels', 'NF-κB, TNF-α, and IL-6 levels indicated aggravation of the inflammatory reaction and the increase S-100β protein and NSE levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",90.0,0.0410178,"The levels of the NF-κB, S-100β protein, NSE, TNF-α, IL-6 were significantly higher at T2, T3, or T4 than before the surgery (T1) in the control group or the dexmedetomidine groups.","[{'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Department of Anesthesiology Children's Hospital Affiliated to Zhengzhou University Henan Children's Hospital Zhengzhou Children' s Hospital Henan Engineering Research Center of Childhood Neurodevelopment Zhengzhou China.""}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Pharmaceutical Science University of Buffalo Buffalo New York USA.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology Children's Hospital Affiliated to Zhengzhou University Henan Children's Hospital Zhengzhou Children' s Hospital Henan Engineering Research Center of Childhood Neurodevelopment Zhengzhou China.""}, {'ForeName': 'Yingping', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': ""Department of Anesthesiology Children's Hospital Affiliated to Zhengzhou University Henan Children's Hospital Zhengzhou Children' s Hospital Henan Engineering Research Center of Childhood Neurodevelopment Zhengzhou China.""}]",Pediatric investigation,['10.1002/ped4.12176']
2502,32846549,Gain vs. loss-framing for reducing sugar consumption: Insights from a choice experiment with six product categories.,"Front-of-package (FOP) nutrition labelling schemes use different framing to highlight nutrient content and promote healthier food choices. Health logos and nutritional warnings can be positioned on opposite sides of a continuous that goes from highlighting healthful products (gain-frame) to highlight unhealthful products (loss-frame), respectively. The aim of the present work was to evaluate the impact of health logos and nutritional warnings on consumers' choice of products with lower sugar content, and the impact of the two FOP nutrition labelling schemes on consumers' associations with sugar. An online study with 1232 people was carried out. Participants were randomly assigned to three experimental conditions: control (no information), health logos and nutritional warnings. They were presented with a series of three packages of different product categories featuring the corresponding information about sugar content and they had to indicate the product they would buy. After completing the choice tasks, they had to complete a word association task about sugar. Results confirmed that the inclusion of FOP nutrition labelling schemes containing information about sugar content encouraged consumers to select the product with lower sugar content. A larger proportion of participants selected the product with the lowest sugar content when packages featured nutritional warnings compared to when they featured health logos. Results from the word association task showed that nutritional warnings made the negative health effects of sugar more salient on consumers' mind. These results suggest that FOP nutrition labelling schemes based on a loss-frame to sugar content may be more efficient at encouraging healthier food choices than gain-frame schemes.",2020,A larger proportion of participants selected the product with the lowest sugar content when packages featured nutritional warnings compared to when they featured health logos.,['1232 people'],"['control (no information), health logos and nutritional warnings']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],1232.0,0.023205,A larger proportion of participants selected the product with the lowest sugar content when packages featured nutritional warnings compared to when they featured health logos.,"[{'ForeName': 'Marcela de', 'Initials': 'M', 'LastName': 'Alcantara', 'Affiliation': 'PDJ-CNPq/Embrapa Agroindústria de Alimentos, Av. das Américas, 29501, CEP 23.020-470 Rio de Janeiro/RJ, Brazil. Electronic address: rosires.deliza@embrapa.br.'}, {'ForeName': 'Gastón', 'Initials': 'G', 'LastName': 'Ares', 'Affiliation': 'Sensometrics & Consumer Science, Instituto Polo Tecnológico de Pando, Facultad de Química, Universidad de la República, By Pass de Rutas 8 y 101 s/n, CP 91000 Pando, Canelones, Uruguay; Centro de Investigación Básica en Psicología, Facultad de Psicología, Universidad de la República, Tristán Narvaja 1674, C.P. 11200 Montevideo, Uruguay.'}, {'ForeName': 'Isabelle Paes Leme', 'Initials': 'IPL', 'LastName': 'de Castro', 'Affiliation': 'Institute of Chemistry, Federal University of Rio de Janeiro, Cidade Universitária, Avenida Athos da Silveira Ramos, 149 Bloco A - 5° andar, CEP 21941-909 Rio de Janeiro/RJ, Brazil.'}, {'ForeName': 'Rosires', 'Initials': 'R', 'LastName': 'Deliza', 'Affiliation': 'Embrapa Agroindústria de Alimentos, Av. das Américas, 29501, CEP 23.020-470 Rio de Janeiro/RJ, Brazil.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2020.109458']
2503,32846573,A mango (Mangifera indica L.) juice by-product reduces gastrointestinal and upper respiratory tract infection symptoms in children.,"The study aimed to evaluate the effect of a mango juice by-product (JBP) on upper-respiratory and gastrointestinal tract infection symptoms in children (6-8 y) in a randomized, double-blind, parallel, case-control study. For two months, children drank either flavored water (control group) or a mango JBP-based beverage (0.04 g·ml -1 ; treatment group); such beverage provided 1.1 g, 278.6 mg and 7.8 mg of dietary fiber, extractable polyphenols (mono-to-hepta galloyl hexosides, mangiferin), and hydrolysable polyphenols (ellagic/gallic acid) per portion, respectively. Mango JBP reduced the incidence of gastrointestinal (flatulencies and abdominal inflammation; p ≤ 0.007) and upper-tract respiratory (crystalline mucus, itchy throat, runny nose, itchy nose, and sneezing; p ≤ 0.038) and such benefits were associated to increased serum levels of PAI-I, MIP-1a, and MIP-1b (p ≤ 0.04) and decreased levels of IgG, MIF, and osteopontin (p ≤ 0.01). We concluded that JBP-based beverage has immunomodulatory properties, useful to prevent or even treat common infectious diseases in school-age children.",2020,"Mango JBP reduced the incidence of gastrointestinal (flatulencies and abdominal inflammation; p ≤ 0.007) and upper-tract respiratory (crystalline mucus, itchy throat, runny nose, itchy nose, and sneezing; p ≤ 0.038) and such benefits were associated to increased serum levels of PAI-I, MIP-1a, and MIP-1b (p ≤ 0.04) and decreased levels of IgG, MIF, and osteopontin (p ≤ 0.01).","['children', 'children (6-8 y', 'school-age children']","['JBP', 'mango juice by-product (JBP', 'mango JBP-based beverage (0.04\xa0g·ml -1 ; treatment group); such beverage provided 1.1\xa0g, 278.6\xa0mg and 7.8\xa0mg of dietary fiber, extractable polyphenols (mono-to-hepta galloyl hexosides, mangiferin), and hydrolysable polyphenols (ellagic/gallic acid']","['levels of IgG, MIF, and osteopontin', 'upper-respiratory and gastrointestinal tract infection symptoms', 'serum levels of PAI-I, MIP-1a, and MIP-1b', 'incidence of gastrointestinal (flatulencies and abdominal inflammation', 'upper-tract respiratory (crystalline mucus, itchy throat, runny nose, itchy nose, and sneezing']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C3256421', 'cui_str': 'Mango Juice'}, {'cui': 'C0360301', 'cui_str': 'Product base'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0024429', 'cui_str': 'Macrophage inhibitory factor'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen activator inhibitor'}, {'cui': 'C1871788', 'cui_str': 'CCL3 protein, human'}, {'cui': 'C1429582', 'cui_str': 'CCL4 protein, human'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0700184', 'cui_str': 'Throat irritation'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0850060', 'cui_str': 'Nasal pruritus'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}]",,0.120309,"Mango JBP reduced the incidence of gastrointestinal (flatulencies and abdominal inflammation; p ≤ 0.007) and upper-tract respiratory (crystalline mucus, itchy throat, runny nose, itchy nose, and sneezing; p ≤ 0.038) and such benefits were associated to increased serum levels of PAI-I, MIP-1a, and MIP-1b (p ≤ 0.04) and decreased levels of IgG, MIF, and osteopontin (p ≤ 0.01).","[{'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Anaya-Loyola', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'García-Marín', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'García-Gutiérrez', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castaño-Tostado', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'Rosalía', 'Initials': 'R', 'LastName': 'Reynoso-Camacho', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'López-Ramos', 'Affiliation': 'Unidad de Investigación Biomédica de Zacatecas, IMSS, Zacatecas 98000, Mexico.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Enciso-Moreno', 'Affiliation': 'Unidad de Investigación Biomédica de Zacatecas, IMSS, Zacatecas 98000, Mexico.'}, {'ForeName': 'Iza F', 'Initials': 'IF', 'LastName': 'Pérez-Ramírez', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico. Electronic address: iza.perez@uaq.mx.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2020.109492']
2504,32846762,Efficacy of music-based cognitive behavior therapy on the management of test-taking behavior of children in basic science using a randomized trial group: Implication for community development.,"BACKGROUND


This study sought the efficacy of cognitive-behavioral therapy-based music group (CBT-Music) intervention program on primary school children's test-taking behavior in Southeast Nigeria.
METHODS


A pretest, posttest randomized controlled trial experimental design was adopted for the study using a sample of 53 primary three (3) children. A test-taking behavior questionnaire was used for data collection. The instrument was face validated by test development experts. Construct validation of the instrument was done by subjecting the instrument to factor analysis after trial testing. Data were analyzed using independent samples t-test and paired samples t-test.
RESULTS


The findings of the study revealed that CBT-Music had a significant effect on the management of test-taking behavior of among children. Furthermore, the test-taking scores of children in the music-based CBT group were significantly lower than those in the control group at the follow-up measure. This implies that the test-taking behavior of the children can be better managed using the CBT-music intervention program to enable the children to grow better academically and contribute to the community they belong to.
CONCLUSION


Music-based CBT demonstrated significant efficacy in the management of children's test-taking behavior. Thus, primary school teachers should be enlightened on how to make use of CBT-Music in the management of test-taking behavior among children.",2020,The findings of the study revealed that CBT-Music had a significant effect on the management of test-taking behavior of among children.,"['primary school teachers', ""primary school children's test-taking behavior in Southeast Nigeria"", 'sample of 53 primary three (3) children']","['cognitive-behavioral therapy-based music group (CBT-Music) intervention program', 'Music-based CBT', 'music-based cognitive behavior therapy']",[],"[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0871510', 'cui_str': 'Test-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],3.0,0.0285278,The findings of the study revealed that CBT-Music had a significant effect on the management of test-taking behavior of among children.,"[{'ForeName': 'Matthias U', 'Initials': 'MU', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Chinedu I O', 'Initials': 'CIO', 'LastName': 'Okeke', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Gloria C', 'Initials': 'GC', 'LastName': 'Ugwu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chizoba L', 'Initials': 'CL', 'LastName': 'Obikwelu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Obiozor', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Dorida N', 'Initials': 'DN', 'LastName': 'Oyigbo', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mbam', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}]",Medicine,['10.1097/MD.0000000000021535']
2505,32843262,Effects of an empowerment-based intervention on health-related knowledge and resilience in patients with coronary artery stent implantation.,"OBJECTIVES


To examine the effects of an empowerment-based intervention on health-related knowledge and resilience among patients after coronary artery stent implantation.
METHODS


This was a randomized controlled trial with a 4-week-long intervention. Participants were randomly allocated to an empowerment-based intervention group (n = 42) or control group (n = 43). Knowledge on CHD and resilience were evaluated and compared between groups.
RESULTS


Compared with the control group, patients in the intervention group showed higher score changes for CHD total knowledge (U = 196.500; P ＜ 0.001) and its 5 dimensions including CHD definition (U = 657.500; P = 0.022), manifestation (U = 245.000; P ＜ 0.001), examination (U = 639.000; P = 0.015), treatment (U = 475.000; P ＜ 0.001), and medication (U = 465.000; P ＜ 0.001), and higher level of resilience (t = 3.235; P = 0.002).
CONCLUSION


The empowerment-based intervention was effective in enhancing the knowledge on CHD and improving resilience for patients with coronary artery stent implantation.
PRACTICE IMPLICATIONS


The structured empowerment-based intervention provides a basis for facilitating the use of this intervention in patients with coronary heart disease.",2020,"The empowerment-based intervention was effective in enhancing the knowledge on CHD and improving resilience for patients with coronary artery stent implantation.
","['patients with coronary artery stent implantation', 'patients with coronary heart disease', 'patients after coronary artery stent implantation']","['empowerment-based intervention group', 'empowerment-based intervention']","['higher level of resilience', 'CHD definition', 'higher score changes for CHD total knowledge', 'health-related knowledge and resilience']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",43.0,0.0568689,"The empowerment-based intervention was effective in enhancing the knowledge on CHD and improving resilience for patients with coronary artery stent implantation.
","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: 739368455@qq.com.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: huayan1112@126.com.""}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: liuwen@fmmu.edu.cn.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: 769003475@qq.com.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xiao', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: 812698871@qq.com.""}, {'ForeName': 'Xiangni', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: 15191455236@163.com.""}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Shao', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: peipeisweet@163.com.""}, {'ForeName': 'Chunping', 'Initials': 'C', 'LastName': 'Ni', 'Affiliation': ""Fourth Military Medical University, School of Nursing, Xi'an, China. Electronic address: pingchunni@163.com.""}, {'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Fourth Military Medical University, The First Affiliated Hospital, Xi'an, China. Electronic address: xzyangxl@fmmu.edu.cn.""}]",Patient education and counseling,['10.1016/j.pec.2020.07.023']
2506,32843265,Development and effectiveness assessment of a Persian-language smartphone application for celiac patients: A randomized controlled clinical trial.,"OBJECTIVES


We aimed to design a Persian-language application for celiac patients and assess its effectiveness on patients` knowledge and adherence to a gluten-free diet (GFD).
METHODS


In the present randomized controlled clinical trial, 60 patients were randomly assigned to receive education through a smartphone application (n = 30) or conventional clinical education (n = 30). The primary outcomes were assessing knowledge about celiac disease and GFD, and adherence to GFD that were assessed at baseline and three months after interventions. The knowledge and adherence were assessed by a valid author-designed knowledge questionnaire and the validated celiac disease adherence test (CDAT) respectively.
RESULTS


The mean disease duration was 4.38 ± 3.27 years. The mean post-intervention score of knowledge about gluten-free foods was significantly higher in the intervention group compared with the placebo group after adjusting for baseline values and characteristics (p-value = 0.03). There was a significant difference in post-intervention CDAT values between the two groups (p-value = 0.01).
CONCLUSION


The smartphone application had a significant effect on celiac patients` knowledge about gluten-free foods and adherence to GFD.
PRACTICE IMPLICATIONS


The smartphone applications can be designed according to each country's particular circumstances and can be suggested by nutritionists and physicians to use by celiac patients.",2020,"The smartphone application had a significant effect on celiac patients` knowledge about gluten-free foods and adherence to GFD.
","['60 patients', 'celiac patients', 'patients` knowledge and adherence to a gluten-free diet (GFD']","['smartphone application (n\u2009=\u200930) or conventional clinical education', 'Persian-language smartphone application', 'placebo']","['celiac patients` knowledge about gluten-free foods and adherence to GFD', 'post-intervention CDAT values', 'knowledge and adherence', 'knowledge about celiac disease and GFD, and adherence to GFD', 'mean post-intervention score of knowledge about gluten-free foods', 'mean disease duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0589717', 'cui_str': 'Gluten-free food product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",60.0,0.110702,"The smartphone application had a significant effect on celiac patients` knowledge about gluten-free foods and adherence to GFD.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Nikniaz', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Shirmohammadi', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari Namvar', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Daneshgah Streat, Tabriz, Iran. Electronic address: zahranamvar1993@gmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.014']
2507,32843284,The Effectiveness of Local Hot and Cold Applications on Peripheral Intravenous Catheterization: A Randomized Controlled Trial.,"PURPOSE


This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, insertion time, and vein evaluation before peripheral venous catheter (PVC) insertion.
DESIGN


This randomized controlled trial was conducted with 90 patients who were hospitalized in the cardiology department of a university hospital.
METHODS


All the data were collected using a patient information form, the Numeric Rating Scale, and Vein Assessment Scale for the assessment of pain and anxiety. Before PVC was inserted, the researcher applied a hot application or a cold application to the catheter insertion site for 1 minute.
FINDINGS


Pain level was found to be significantly lower in the hot and cold application groups than the control group, and no difference was determined between the hot and cold application groups. The anxiety levels of the patients were significantly lower in the hot application group than the cold application and control groups (P < .05).
CONCLUSIONS


Applying local hot and cold application before inserting the PVC reduced both pain and anxiety levels of the patients. However, hot application increased vein visibility and patient satisfaction and shortened the insertion time, whereas cold application decreased vein visibility, prolonged the insertion time, and decreased patient satisfaction.",2020,"FINDINGS


Pain level was found to be significantly lower in the hot and cold application groups than the control group, and no difference was determined between the hot and cold application groups.","['90 patients who were hospitalized in the cardiology department of a university hospital', 'Peripheral Intravenous Catheterization']","['local hot and cold applications', 'Local Hot and Cold Applications']","['vein visibility, prolonged the insertion time, and decreased patient satisfaction', 'pain and anxiety levels', 'vein visibility and patient satisfaction', 'anxiety levels', 'pain, anxiety level, insertion time, and vein evaluation before peripheral venous catheter (PVC) insertion', 'Pain level', 'Numeric Rating Scale, and Vein Assessment Scale for the assessment of pain and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0587453', 'cui_str': 'Cardiology department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",90.0,0.0334682,"FINDINGS


Pain level was found to be significantly lower in the hot and cold application groups than the control group, and no difference was determined between the hot and cold application groups.","[{'ForeName': 'Sevda', 'Initials': 'S', 'LastName': 'Korkut', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey. Electronic address: skorkut@erciyes.edu.tr.'}, {'ForeName': 'Songül', 'Initials': 'S', 'LastName': 'Karadağ', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Doğan', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Sanko University, Gaziantep, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.04.011']
2508,32843285,The Effect of Preoperative Nutrition on Postoperative CRP and Albumin Levels in Patients Undergoing Laparoscopic Surgery: A Surgical Nursing Perspective.,"PURPOSE


The purpose of this study was to investigate the effect of preoperative oral carbohydrate on postoperative serum C-reactive protein (CRP) and albumin levels in patients laparoscopic surgery.
DESIGN


This is an experimental study with intervention and control groups.
METHODS


Sixty-six patients who underwent elective laparoscopic cholecystectomy were included (intervention, n = 33; control, n = 33). The patients in the intervention group were given 400 mL of oral liquid carbohydrate 2 hours before surgery. Blood samples were collected from the two groups with serum CRP and albumin levels measured 2 hours before surgery and 24 hours postoperatively.
FINDINGS


CRP levels in the intervention group 2 hours before surgery and 24 hours postoperatively were higher than the control group (P = .028; P = .014, respectively). CRP levels of the patients in the intervention group 24 hours postoperatively (26.98 ± 18.60 mg/L) were higher than the preoperative level (9.37 ± 15.68 mg/L) (P < .001). The CRP level of the patients in the control group 24 hours postoperatively (16.24 ± 16.01 mg/L) was higher than the preoperative level (3.11 ± 3.12 mg/L) (P < .001). There was no difference between the serum albumin levels of the patients in the intervention and control groups measured 24 hours postoperatively (P = .103).
CONCLUSIONS


We determined that 400 mL oral liquid carbohydrate given preoperatively had no anabolic effect on serum CRP and albumin levels.",2020,2 hours before surgery and 24 hours postoperatively were higher than the control group (P = .028,"['Patients Undergoing Laparoscopic Surgery', 'patients laparoscopic surgery', 'Sixty-six patients who underwent']","['400\xa0mL of oral liquid carbohydrate', 'Preoperative Nutrition', 'elective laparoscopic cholecystectomy', 'preoperative oral carbohydrate', '400\xa0mL oral liquid carbohydrate']","['serum CRP and albumin levels', 'Postoperative CRP and Albumin Levels', 'postoperative serum C-reactive protein (CRP) and albumin levels', 'CRP levels', 'serum albumin levels', 'CRP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1273619', 'cui_str': 'Oral Liquid Product'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",66.0,0.0221928,2 hours before surgery and 24 hours postoperatively were higher than the control group (P = .028,"[{'ForeName': 'Kenan', 'Initials': 'K', 'LastName': 'Gumus', 'Affiliation': 'Department of Surgical Nursing, Amasya University, Amasya, Turkey. Electronic address: kenan.gumus@amasya.edu.tr.'}, {'ForeName': 'Gokcen', 'Initials': 'G', 'LastName': 'Aydın', 'Affiliation': 'Department of Surgical Nursing, Bozok University, Yozgat, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.06.018']
2509,32843372,Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Expanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free  λ  light chains at 24 weeks of treatment.
RESULTS


Among 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free  λ  light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both  P <0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
CONCLUSIONS


Hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free  λ  light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.",2020,"Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
","['86 patients randomized to each dialyzer, 65 completed the trial in each group', '172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years', 'Clinically stable patients on maintenance hemodialysis']","['Elisio-17H', 'dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H', 'Expanded Hemodialysis with the Theranova 400 Dialyzer', 'hemodialysis treatment with a medium cut-off dialyzer']","['reduction ratio for the removal of free  λ  light chains', 'complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin', 'efficacy and safety', 'Safety and Efficacy', 'predialysis serum albumin level', 'Efficacy and Safety', 'reduction ratio of free  λ  light chains', 'IL-6. Predialysis serum albumin levels', 'predialysis serum albumin levels', 'larger reduction ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0033457', 'cui_str': 'Complement factor D'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",86.0,0.0677605,"Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
","[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Tufts Medical Center, Medicine, Nephrology, Boston, Massachusetts.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Falzon', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, San Gwann, Malta luke_falzon@baxter.com.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Skoufos', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Angelito', 'Initials': 'A', 'LastName': 'Bernardo', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Beck', 'Affiliation': 'Baxter International Inc., Worldwide Medical, Hechingen, Germany.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Tran', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01210120']
2510,32843374,Changes in Blood Pressure and Arterial Hemodynamics following Living Kidney Donation.,"BACKGROUND AND OBJECTIVES


The Effect of a Reduction in GFR after Nephrectomy on Arterial Stiffness and Central Hemodynamics (EARNEST) study was a multicenter, prospective, controlled study designed to investigate the associations of an isolated reduction in kidney function on BP and arterial hemodynamics.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research. Participants underwent office and ambulatory BP measurement, assessment of arterial stiffness, and biochemical tests at baseline and 12 months.
RESULTS


A total of 469 participants were recruited, and 306 (168 donors and 138 controls) were followed up at 12 months. In the donor group, mean eGFR was 27 ml/min per 1.73 m 2  lower than baseline at 12 months. Compared with baseline, at 12 months the mean within-group difference in ambulatory day systolic BP in donors was 0.1 mm Hg (95% confidence interval, -1.7 to 1.9) and 0.6 mm Hg (95% confidence interval, -0.7 to 2.0) in controls. The between-group difference was -0.5 mm Hg (95% confidence interval, -2.8 to 1.7;  P =0.62). The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls. The between-group difference was 0.1 m/s (95% confidence interval, -0.2 to 0.3;  P =0.49).
CONCLUSIONS


Changes in ambulatory peripheral BP and pulse wave velocity in kidney donors at 12 months after nephrectomy were small and not different from controls.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


NCT01769924 (https://clinicaltrials.gov/ct2/show/NCT01769924).",2020,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","['Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research', 'A total of 469 participants were recruited, and 306 (168 donors and 138 controls', 'Living Kidney Donation']",[],"['ambulatory peripheral BP and pulse wave velocity', 'Blood Pressure and Arterial Hemodynamics', 'ambulatory day systolic BP', 'mean eGFR', 'pulse wave velocity']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",469.0,0.332628,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Price', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom annaprice@doctors.org.uk.'}, {'ForeName': 'George H B', 'Initials': 'GHB', 'LastName': 'Greenhall', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Moody', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Steeds', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Edwards', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Manvir K', 'Initials': 'MK', 'LastName': 'Hayer', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Pickup', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Radhakrishnan', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Law', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': ""Renal and Transplantation Unit, St George's University Hospitals National Health Service Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Charles R V', 'Initials': 'CRV', 'LastName': 'Tomson', 'Affiliation': 'Southmead Hospital, Bristol, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cockcroft', 'Affiliation': 'Department of Cardiology, Wales Heart Research Institute, University Hospital, Cardiff, United Kingdom.'}, {'ForeName': 'Badri', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': ""Cambridge Clinical Trials Unit, Clinical School, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom.""}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Tomlinson', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ferro', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Townend', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.15651219']
2511,32843424,Moderate calorie restriction improves cardiometabolic risk factors in healthy individuals.,"Commentary by:  Dr James Kimpton and Dr Teck Khong Clinical Pharmacology, St George's, University of London, UK Series Editor:  Dr Teck Khong, DTB Associate Editor Clinical Pharmacology, St George's, University of London, UK Commentary on:  Kraus WE, Bhapkar M, Huffman KM,  et al  2 years of calorie restriction and cardiometabolic (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial.  Lancet Diabetes Endocrinol  2019; 7: 673-83.",2020,Commentary by:  Dr James Kimpton and Dr Teck,"['Lancet Diabetes Endocrinol  2019', 'healthy individuals']","['Moderate calorie restriction', 'Dr James Kimpton and Dr Teck']",['cardiometabolic risk factors'],"[{'cui': 'C0777169', 'cui_str': 'Lancet'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.0193669,Commentary by:  Dr James Kimpton and Dr Teck,"[{'ForeName': 'Teck K', 'Initials': 'TK', 'LastName': 'Khong', 'Affiliation': ""Clinical Pharmacology, St George's University of London, London, UK tkhong@sgul.ac.uk.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kimpton', 'Affiliation': ""Clinical Pharmacology, St George's University of London, London, UK.""}]",Drug and therapeutics bulletin,['10.1136/dtb.2020.000042']
2512,32843496,Improvement of ejection fraction and mortality in ischaemic heart failure.,"OBJECTIVE


The frequency and predictors of improvement in left ventricular ejection fraction (LVEF) in ischaemic cardiomyopathy and its association with mortality is poorly understood. We sought to assess the predictors of LVEF improvement ≥10% and its effect on mortality.
METHODS


We compared characteristics of patients enrolled in The Surgical Treatment for Ischaemic Heart Failure (STICH) trial with and without improvement of LVEF ≥10% at 24 months. A logistic regression model was constructed to determine the independent predictors of LVEF improvement. A Cox proportional hazards model was created to assess the independent association of improvement in LVEF ≥10% with mortality.
RESULTS


Of the 1212 patients enrolled in STICH, 618 underwent echocardiographic assessment of LVEF at baseline and 24 months. Of the patients randomised to medical therapy plus coronary artery bypass graft surgery (CABG), 58 (19%) had an improvement in LVEF  > 10% compared with 51 (16%) patients assigned to medical therapy alone (p=0.30). Independent predictors of LVEF improvement  > 10% included prior myocardial infarction (OR 0.44, 95% CI: 0.28 to 0.71, p=0.001) and lower baseline LVEF (OR 0.94, 95% CI: 0.91 to 0.97, p<0.001). Improvement in LVEF  > 10% (HR 0.61, 95% CI: 0.44 to 0.84, p=0.004) and randomisation to CABG (HR 0.72, 95% CI: 0.57 to 0.90, p=0.004) were independently associated with a reduced hazard of mortality.
CONCLUSIONS


Improvement of LVEF ≥10% at 24 months was uncommon in patients with ischaemic cardiomyopathy, did not differ between patients assigned to CABG and medical therapy or medical therapy alone and was independently associated with reduced mortality.
TRIAL REGISTRATION NUMBER


NCT00023595.",2020,"CONCLUSIONS


Improvement of LVEF ≥10% at 24 months was uncommon in patients with ischaemic cardiomyopathy, did not differ between patients assigned to CABG and medical therapy or medical therapy alone and was independently associated with reduced mortality.
","['patients enrolled in The Surgical Treatment for Ischaemic Heart Failure (STICH) trial with and without improvement of LVEF ≥10% at 24 months', '1212 patients enrolled in STICH']",['medical therapy plus coronary artery bypass graft surgery (CABG'],"['hazard of mortality', 'ejection fraction and mortality', 'lower baseline LVEF', 'reduced mortality', 'myocardial infarction', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",1212.0,0.0935637,"CONCLUSIONS


Improvement of LVEF ≥10% at 24 months was uncommon in patients with ischaemic cardiomyopathy, did not differ between patients assigned to CABG and medical therapy or medical therapy alone and was independently associated with reduced mortality.
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Perry', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Cardiovascular Division, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Cardiovascular Division, Washington University in St. Louis, St. Louis, Missouri, USA d.brown@wustl.edu.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-316975']
2513,32843581,Can Treadmill Slip-Perturbation Training Reduce Longer-Term Fall Risk Upon Overground Slip Exposure?,"The purpose was to examine and compare the longer-term generalization between 2 different practice dosages for a single-session treadmill slip-perturbation training when reexposed to an overground slip 6 months later. A total of 45 older adults were conveniently assigned to either 24 or 40 slip-like treadmill perturbation trials or a third control group. Overground slips were given immediately after initial training, and at 6 months after initial training in order to examine immediate and longer-term effects. The performance (center of mass stability and vertical limb support) and fall percentage from the laboratory-induced overground slips (at initial posttraining and at 6 mo) were measured and compared between groups. Both treadmill slip-perturbation groups showed immediate generalization at the initial posttraining test and longer-term generalization at the 6-month retest. The higher-practice-dosage group performed significantly better than the control group (P < .05), with no difference between the lower-practice-dosage and the control groups at the 6-month retest (P > .05). A single session of treadmill slip-perturbation training showed a positive effect for reducing older adults' fall risk for laboratory-induced overground slips. A higher-practice dosage of treadmill slip perturbations could be more beneficial for further reducing fall risk.",2020,A single session of treadmill slip-perturbation training showed a positive effect for reducing older adults' fall risk for laboratory-induced overground slips.,['45 older adults'],"['40 slip-like treadmill perturbation trials or a third control group', 'treadmill slip-perturbation training', 'Treadmill Slip-Perturbation Training']",['immediate generalization'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}]",45.0,0.0191298,A single session of treadmill slip-perturbation training showed a positive effect for reducing older adults' fall risk for laboratory-induced overground slips.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Bhatt', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Kessler Foundation.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Shuaijie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Yi-Chung Clive', 'Initials': 'YC', 'LastName': 'Pai', 'Affiliation': 'University of Illinois at Chicago.'}]",Journal of applied biomechanics,['10.1123/jab.2019-0211']
2514,32843590,"Naproxen, isosorbide dinitrate and co-administration cannot prevent post-endoscopic retrograde cholangiopancreatography pancreatitis: Randomized controlled trial.","Backgrounds/Aims


Acute pancreatitis is the most widespread complication of endoscopic retrograde cholangiopancreatography. Here, we investigated the efficacy of rectal suppository naproxen, sublingual isosorbide dinitrate and their co-administration in the prevention of post-ERCP pancreatitis.
Methods


This double-blind randomized clinical trial carried out from June 2015 to February 2016 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran. A total of 585 patients were selected from candidates for diagnostic or therapeutic ERCP by using the simple sampling method. Patients divided into three groups. Group A received 500 mg naproxen, group B took 5 mg isosorbide dinitrate, and group C was co-administrated both agents before ERCP. The primary outcome measure was the development of pancreatitis onset of pain in the upper abdomen and increase of serum amylase activity more than 3 times over the upper normal limit (60-100 IU/L) within first the 24 h post-ERCP.
Results


Totally, 80 patients developed PEP included 29 (4.9%), 24 (4.1%), and 27 (4.6%) patients in groups A, B, and C, respectively ( p =0.845). Longer ERCP time ( p =0.041), using diazepam ( p =0.033), a higher number of pancreatic ducts cannulation ( p ＜0.001), pancreatic duct injection ( p =0.013), and using pancreatic stent ( p =0.004) were the predisposing factors for PEP.
Conclusions


Our findings indicated that prophylactic naproxen suppository or isosorbide dinitrate sublingually or co-administration had no significant difference in the prevention and severity of PEP, however, enhancing the endoscopist's skills can be effective. Departments and educational hospitals should develop their assessment and quality assurance measures for the training of fellows' not only technical training but also an understanding of the diagnostic and therapeutic roles of the procedure.",2020,"Longer ERCP time ( p =0.041), using diazepam ( p =0.033), a higher number of pancreatic ducts cannulation ( p ＜0.001), pancreatic duct injection ( p =0.013), and using pancreatic stent ( p =0.004) were the predisposing factors for PEP.
","['post-endoscopic retrograde cholangiopancreatography pancreatitis', '585 patients were selected from candidates for diagnostic or therapeutic ERCP by using the simple sampling method', 'June 2015 to February 2016 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran']","['diazepam', 'Naproxen, isosorbide dinitrate and co-administration', 'rectal suppository naproxen, sublingual isosorbide dinitrate', 'endoscopic retrograde cholangiopancreatography', 'naproxen', 'isosorbide dinitrate', 'prophylactic naproxen suppository or isosorbide dinitrate']","['pancreatic duct injection', 'number of pancreatic ducts cannulation', 'development of pancreatitis onset of pain in the upper abdomen and increase of serum amylase activity', 'prevention and severity of PEP', 'Longer ERCP time']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0022252', 'cui_str': 'Isosorbide Dinitrate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0991547', 'cui_str': 'Rectal suppository'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0230165', 'cui_str': 'Upper abdomen (surface region)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0201885', 'cui_str': 'Amylase measurement, serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",585.0,0.101831,"Longer ERCP time ( p =0.041), using diazepam ( p =0.033), a higher number of pancreatic ducts cannulation ( p ＜0.001), pancreatic duct injection ( p =0.013), and using pancreatic stent ( p =0.004) were the predisposing factors for PEP.
","[{'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Mansour-Ghanaei', 'Affiliation': 'GI Cancer Screening and Prevention Research Center, Rasht, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Joukar', 'Affiliation': 'GI Cancer Screening and Prevention Research Center, Rasht, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Khalesi', 'Affiliation': 'Caspian Digestive Disease Research Center, Rasht, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Naghipour', 'Affiliation': 'Caspian Digestive Disease Research Center, Rasht, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Sepehrimanesh', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Mojtahedi', 'Affiliation': 'Caspian Digestive Disease Research Center, Rasht, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yeganeh', 'Affiliation': 'GI Cancer Screening and Prevention Research Center, Rasht, Iran.'}, {'ForeName': 'Hamid Saeidi', 'Initials': 'HS', 'LastName': 'Saedi', 'Affiliation': 'GI Cancer Screening and Prevention Research Center, Rasht, Iran.'}, {'ForeName': 'Saba Fakhrieh', 'Initials': 'SF', 'LastName': 'Asl', 'Affiliation': 'Caspian Digestive Disease Research Center, Rasht, Iran.'}]",Annals of hepato-biliary-pancreatic surgery,['10.14701/ahbps.2020.24.3.259']
2515,32843659,Haptic sound-localisation for use in cochlear implant and hearing-aid users.,"Users of hearing-assistive devices often struggle to locate and segregate sounds, which can make listening in schools, cafes, and busy workplaces extremely challenging. A recent study in unilaterally implanted CI users showed that sound-localisation was improved when the audio received by behind-the-ear devices was converted to haptic stimulation on each wrist. We built on this work, using a new signal-processing approach to improve localisation accuracy and increase generalisability to a wide range of stimuli. We aimed to: (1) improve haptic sound-localisation accuracy using a varied stimulus set and (2) assess whether accuracy improved with prolonged training. Thirty-two adults with normal touch perception were randomly assigned to an experimental or control group. The experimental group completed a 5-h training regime and the control group were not trained. Without training, haptic sound-localisation was substantially better than in previous work on haptic sound-localisation. It was also markedly better than sound-localisation by either unilaterally or bilaterally implanted CI users. After training, accuracy improved, becoming better than for sound-localisation by bilateral hearing-aid users. These findings suggest that a wrist-worn haptic device could be effective for improving spatial hearing for a range of hearing-impaired listeners.",2020,These findings suggest that a wrist-worn haptic device could be effective for improving spatial hearing for a range of hearing-impaired listeners.,"['Thirty-two adults with normal touch perception', 'cochlear implant and hearing-aid users']",['Haptic sound-localisation'],"['spatial hearing', 'haptic sound-localisation accuracy']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2350522', 'cui_str': 'Touch perception'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0475264', 'cui_str': 'Localization - action'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0475264', 'cui_str': 'Localization - action'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",32.0,0.0396961,These findings suggest that a wrist-worn haptic device could be effective for improving spatial hearing for a range of hearing-impaired listeners.,"[{'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Fletcher', 'Affiliation': 'University of Southampton Auditory Implant Service, University of Southampton, University Road, Southampton, SO17 1BJ, UK. M.D.Fletcher@soton.ac.uk.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Zgheib', 'Affiliation': 'University of Southampton Auditory Implant Service, University of Southampton, University Road, Southampton, SO17 1BJ, UK.'}]",Scientific reports,['10.1038/s41598-020-70379-2']
2516,32843703,Naltrexone modulates contextual processing in depression.,"Context, the information surrounding an experience, can significantly alter the meaning and the affective responses to events. Yet the biological mechanisms through which context modulate experiences are not entirely understood. Here, we hypothesized that the µ-opioid system-extensively implicated in placebo effects, a clinical phenomenon thought to rely on contextual processing-modulates the effects of contextual information on emotional attributions in patients with depression. To test this hypothesis, 20 unmedicated patients with depression completed a randomized, double-blind, placebo-controlled, crossover study of one dose of 50 mg of naltrexone, or placebo immediately before completing two sessions of the Contextual Framing fMRI task. This task captures effects of valenced contextual cues (pleasant vs. unpleasant) on emotional attribution (the rating of subtle emotional faces: fearful, neutral, or happy). Behaviorally, we found that emotional attribution was significantly moderated by the interaction between contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy), compared to neutral, were more negative during unpleasant, compared to pleasant context cues. At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone. Furthermore, the effects of naltrexone on emotional attribution were partially abolished in more severely depressed patients. Our results provide insights into the molecular alterations underlying context representation in patients with depression, providing pivotal early data for future treatment studies.",2020,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","['patients with depression', '20 unmedicated patients with depression', 'depression']","['placebo', 'Naltrexone', 'naltrexone, or placebo', 'naltrexone', 'valenced contextual cues (pleasant vs. unpleasant']","[""contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy"", 'emotional attribution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",20.0,0.0755192,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mizuno', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lyew', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Karim', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Dombrovski', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. pecinam@upmc.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00809-2']
2517,32843718,Long-term effectiveness of a lifestyle intervention on the prevention of type 2 diabetes in a middle-income country.,"This study aims to assess the effects of a community-based lifestyle intervention program on the incidence of type 2 diabetes (T2D). For this purpose, three communities in Tehran were chosen; one community received a face-to-face educational session embedded in a long-term community-wide lifestyle intervention aimed at supporting lifestyle changes. We followed up 9,204 participants (control: 5,739, intervention: 3,465) triennially from 1999 to 2015 (Waves 1-5). After a median follow-up of 3.5 years (wave 2), the risk of T2D was 30% lower in the intervention community as compared with two control communities by (Hazard-ratio: 0.70 [95% CI 0.53; 0.91]); however, the difference was not statistically significant in the following waves. After a median follow-up of 11.9 years (wave 5), there was a non-significant 6% reduction in the incidence of T2D in the intervention group as compared to the control group (Hazard-ratio: 0.94 [0.81, 1.08]). Moreover, after 11.9 years of follow-up, the intervention significantly improved the diet quality measured by the Dietary Approaches to Stop Hypertension concordance (DASH) score. Mean difference in DASH score in the intervention group versus control group was 0.2 [95% CI 0.1; 0.3]. In conclusion, the intervention prevented T2D by 30% in the short-term (3.5 years) but not long-term; however, effects on improvement of the diet maintained in the long-term.Registration: This study is registered at IRCT, a WHO primary registry ( https://irct.ir ). The registration date 39 is 2008-10-29 and the IRCT registration number is IRCT138705301058N1.",2020,Mean difference in DASH score in the intervention group versus control group was 0.2 [95% CI 0.1; 0.3].,"['Registration', '9,204 participants (control: 5,739, intervention: 3,465) triennially from 1999 to 2015', 'type 2 diabetes in a middle-income country', 'three communities in Tehran were chosen; one community received a']","['community-based lifestyle intervention program', 'lifestyle intervention', 'face-to-face educational session embedded in a long-term community-wide lifestyle intervention']","['incidence of type 2 diabetes (T2D', 'incidence of T2D', 'diet quality', 'Stop Hypertension concordance (DASH) score', 'DASH score', 'risk of T2D']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",9204.0,0.0311052,Mean difference in DASH score in the intervention group versus control group was 0.2 [95% CI 0.1; 0.3].,"[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Lotfaliany', 'Affiliation': 'Non-Communicable Disease Control, School of Population and Global Health, University of Melbourne, Parkville, VIC, 3010, Australia.'}, {'ForeName': 'Mohamad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Hadaegh', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Zafari', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ghanbarian', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mirmiran', 'Affiliation': 'Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Non-Communicable Disease Control, School of Population and Global Health, University of Melbourne, Parkville, VIC, 3010, Australia.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran. dkhalili@endocrine.ac.ir.'}]",Scientific reports,['10.1038/s41598-020-71119-2']
2518,32843762,D-Tagatose Effectively Reduces the Number of Streptococcus mutans and Oral Bacteria in Healthy Adult Subjects: A Chewing Gum Pilot Study and Randomized Clinical Trial.,"We examined the effect of D-Tagatose on the growth of oral bacteria including Streptococcus mutans (S. mutans). Saliva collected from 10 healthy volunteers was plated on BHI medium (to culture total oral bacteria) and MBS medium (to culture S. mutans, specifically). Agar plates of BHI or MBS containing xylitol or D-Tagatose were cultured under aerobic or anaerobic conditions. We then counted the number of colonies. In BHI plates containing D-Tagatose, a complete and significant reduction of bacteria occurred under both aerobic and anaerobic conditions. In MSB medium, significant reduction of S. mutans was also observed. We then performed a doubleblind parallel randomized trial with 19 healthy volunteers. They chewed gum containing xylitol, D-Tagatose, or both for 4 weeks, and their saliva was collected weekly and plated on BHI and MSB media. These plates were cultured under anaerobic conditions. Total bacteria and S. mutans were not effectively reduced in either the D-Tagatose or xylitol gum group. However, S. mutans was significantly reduced in volunteers chewing gum containing both D-Tagatose and xylitol. Thus, D-Tagatose inhibited the growth of S. mutans and many types of oral bacteria, indicating that D-Tagatose intake may help prevent dental caries, periodontitis, and many oral diseases.",2020,"However, S. mutans was significantly reduced in volunteers chewing gum containing both D-Tagatose and xylitol.","['19 healthy volunteers', 'Healthy Adult Subjects', '10 healthy volunteers']","['Tagatose', 'MBS containing xylitol or D']","['Number of Streptococcus mutans and Oral Bacteria', 'bacteria', 'reduction of S. mutans', 'Total bacteria and S. mutans']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0075773', 'cui_str': 'tagatose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",19.0,0.0216497,"However, S. mutans was significantly reduced in volunteers chewing gum containing both D-Tagatose and xylitol.","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Nagamine', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}, {'ForeName': 'Khaleque', 'Initials': 'K', 'LastName': 'Hasibul', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}, {'ForeName': 'Ayano', 'Initials': 'A', 'LastName': 'Tada', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}, {'ForeName': 'Kazuyo', 'Initials': 'K', 'LastName': 'Kamitori', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Medical Technology, Division of Fundamental Medical Technology, Ehime Prefectural University of Health Sciences, Tobe-cho, Ehime 791-2101, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Tokuda', 'Affiliation': 'International Office, Kagawa University, Takamatsu 760-8521, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Kuwahara', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 760-0793, Japan.'}]",Acta medica Okayama,['10.18926/AMO/60369']
2519,32843784,A Randomized Controlled Study to Compare Hemodynamic Effects between Clonidine and Pregabalin in Laparoscopic Cholecystectomy.,"Background


Laparoscopic cholecystectomy (LC) is associated with pneumoperitoneum and hemodynamic disturbances. Pregabalin and Clonidine have been used for anesthetic effects, but a better drug for controlling hemodynamic parameters is being investigated.
Aims


The study was done to assess and compare the efficacy of preoperative single oral dose of pregabalin and clonidine in maintaining the hemodynamic parameters in the LC.
Settings and Design


The prospective, interventional, randomized, comparative, single-blinded study was conducted in the department of anesthesia and surgery from January 2015 to September 2016 after taking approval from the institutional ethical committee.
Materials and Methods


The study included a total of 90 patients, aged between 18 and 56 years of both sexes scheduled for elective LC. Patients were randomized into three groups of 30 each who received oral pregabalin 150 mg, clonidine 200 ug, and placebo. The hemodynamic parameters were recorded at various time intervals along with any adverse events.
Statistical Analysis


Quantitative variables were compared using unpaired  t -test (when the data sets were not normally distributed) between the two groups. Qualitative variables were compared using Chi-square test/Fisher's exact test.  P  < 0.05 was considered statistically significant.
Results


There was a significant increase in the heart rate (HR) and systolic, diastolic, and mean blood pressure during laryngoscopy and pneumoperitoneum in the control group as compared to both pregabalin and clonidine. HR was significantly lower in clonidine group after extubation and in postoperative period than both control group and pregabalin group. There was no major difference in the incidence of side effects.
Conclusion


Both pregabalin (150 mg) and clonidine (200 ug) were effective in controlling the hemodynamic parameters during LC, with clonidine providing better hemodynamic stability than Pregabalin.",2020,"Both pregabalin (150 mg) and clonidine (200 ug) were effective in controlling the hemodynamic parameters during LC, with clonidine providing better hemodynamic stability than Pregabalin.","['Laparoscopic Cholecystectomy', '90 patients, aged between 18 and 56 years of both sexes scheduled for elective LC', 'department of anesthesia and surgery from January 2015 to September 2016 after taking approval from the institutional ethical committee']","['Clonidine and Pregabalin', 'Clonidine', 'oral pregabalin 150 mg, clonidine 200 ug, and placebo', 'pregabalin', 'Pregabalin', 'clonidine', 'pregabalin and clonidine', '\n\n\nLaparoscopic cholecystectomy (LC']","['HR', 'heart rate (HR) and systolic, diastolic, and mean blood pressure during laryngoscopy and pneumoperitoneum', 'incidence of side effects', 'hemodynamic stability']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0026531', 'cui_str': 'Morality'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1648912', 'cui_str': 'pregabalin 150 MG [Lyrica]'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",90.0,0.0349794,"Both pregabalin (150 mg) and clonidine (200 ug) were effective in controlling the hemodynamic parameters during LC, with clonidine providing better hemodynamic stability than Pregabalin.","[{'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesiology, BJ Medical College, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Monal', 'Initials': 'M', 'LastName': 'Ramani', 'Affiliation': 'Department of Anaesthesiology, BJ Medical College, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anaesthesiology, BJ Medical College, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesiology, BJ Medical College, Ahmedabad, Gujarat, India.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Sarvanan', 'Affiliation': 'Department of Anaesthesiology, BJ Medical College, Ahmedabad, Gujarat, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_15_20']
2520,32843785,Safety and Efficacy of Ultra-Low-Dose Intracavernosal Adrenaline for Intraoperative Penile Erection in Transurethral Surgeries under Spinal Anesthesia.,"Context


Penile tumescence during endoscopic urological surgeries is a rare but problematic complication that can lead to postponement of the surgery. This study was done to assess the efficacy of ultra-low-dose intracavernosal adrenaline in the management of intraoperative penile erection.
Subjects and Methods


Between January 2015 and December 2019, all the patients who developed significant penile tumescence during endourology procedures following regional anesthesia were included. Twenty patients required intervention. They were given half milliliter of solution containing 2.5 μg of adrenaline with insulin syringe. Baseline systolic and diastolic blood pressure, heart rate, and oxygen saturation were noted and were recorded at 1, 2, 3, 4, and 5 min after giving adrenaline. Time to achieve complete detumescence and any other related complications were also noted.
Results


Penile detumescence was achieved in 2.6 ± 0.47 min in all the patients. There was an increase in heart rate from baseline value which increased to maximum by 3 min and returned back to baseline by 5 min. Systolic and diastolic blood pressure remained unchanged.
Conclusion


All the patients achieved penile detumescence without any significant adverse effects after receiving intracavernosal injection of ultra-low-dose adrenaline.",2020,All the patients achieved penile detumescence without any significant adverse effects after receiving intracavernosal injection of ultra-low-dose adrenaline.,"['Transurethral Surgeries under Spinal Anesthesia', 'Twenty patients required intervention', 'Subjects and Methods\n\n\nBetween January 2015 and December 2019, all the patients who developed significant penile tumescence during endourology procedures following regional anesthesia were included']","['ultra-low-dose intracavernosal adrenaline', 'Ultra-Low-Dose Intracavernosal Adrenaline', 'adrenaline with insulin syringe', 'adrenaline']","['Systolic and diastolic blood pressure', 'heart rate', 'Penile tumescence', 'Baseline systolic and diastolic blood pressure, heart rate, and oxygen saturation', 'Penile detumescence']","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0087121', 'cui_str': 'Tumescence, Penile'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0087121', 'cui_str': 'Tumescence, Penile'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}]",,0.143325,All the patients achieved penile detumescence without any significant adverse effects after receiving intracavernosal injection of ultra-low-dose adrenaline.,"[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Urology, Government Medical College, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Sunana', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesia, ASCOMS, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Anaesthesia, Government Medical College, Jammu, Jammu and Kashmir, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_25_20']
2521,32843787,Randomized Controlled Trial to Compare Baska® Mask versus ProSeal Laryngeal Mask Airway for General Anesthesia with Intermittent Positive Pressure Ventilation.,"Introduction


A myriad of supraglottic airway devices (SADs) are developed over time to search the device that conforms to the anatomy of the human respiratory tract noninvasively, but these devices are associated with the risk of aspiration. Baska ®  mask (BM) is the latest addition to the family of SADs to circumvent the incidence of aspiration.
Aims of Study


The aim of the study was to compare the sealing pressure and rapidity of the insertion of BM with ProSeal laryngeal mask (PLM) airway and the incidence of laryngopharyngeal morbidity between two devices.
Materials and Methods


A randomized prospective open-label study was done on sixty adult patients of the age group of 18-60 years after approval from the institutional ethical committee and registration of trial in the Clinical Trials Registry. The patients were randomly divided into two groups: Group I (BM) where BM was inserted after the induction of general anesthesia and Group II (PLM) where PLM was inserted after induction. The airway sealing pressure in BM was calculated. The mean time of insertion of respective SAD and the number of successful attempts were also recorded in both groups. For analysis of continuous variables, independent sample Student's  t -test was applied, and for categorical variables, Chi-square test was used.  P  < 0.05 was considered statistically significant.
Results


The rate of successful attempts of insertion was comparable in both the groups. The mean insertion time was 14.25 ± 3.82 s in BM group and 22.01 ± 2.64 s in PLM group, which was statistically significant. The airway sealing pressure was 30.25 ± 3.34 cmH 2 O in BM group and 23.50 ± 4.05 cmH 2 O in PLM group, which was also statistically significant.
Conclusion


BM has better ease of insertion with adequate sealing pressure as compared to PLM airway, thus reducing the chances of aspiration and offering its potential application in securing airway in emergency situations.",2020,The rate of successful attempts of insertion was comparable in both the groups.,"['sixty adult patients of the age group of 18-60 years after approval from the institutional ethical committee and registration of trial in the Clinical Trials Registry', 'General Anesthesia with Intermittent Positive Pressure Ventilation']","['supraglottic airway devices (SADs', 'Baska ®  mask (BM', 'Baska® Mask versus ProSeal Laryngeal Mask Airway', 'BM with ProSeal laryngeal mask (PLM']","['laryngopharyngeal morbidity', 'rate of successful attempts of insertion', 'mean insertion time', 'mean time of insertion of respective SAD and the number of successful attempts', 'airway sealing pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}]","[{'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",60.0,0.0345373,The rate of successful attempts of insertion was comparable in both the groups.,"[{'ForeName': 'Balwinderjit', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesia, PIMS, Jalandhar, Punjab, India.'}, {'ForeName': 'Arwinder Pal', 'Initials': 'AP', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesia, PIMS, Jalandhar, Punjab, India.'}, {'ForeName': 'Joginder Pal', 'Initials': 'JP', 'LastName': 'Attri', 'Affiliation': 'Department of Anesthesia, GMC, Amritsar, Punjab, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_23_20']
2522,32846971,Effect of an EMG-FES Interface on Ankle Joint Training Combined with Real-Time Feedback on Balance and Gait in Patients with Stroke Hemiparesis.,"This study evaluated the effects of an electromyography-functional electrical stimulation interface (EMG-FES interface) combined with real-time balance and gait feedback on ankle joint training in patients with stroke hemiplegia. Twenty-six stroke patients participated in this study. All subjects were randomly assigned to either the EMG-FES interface combined with real-time feedback on ankle joint training (RFEF) group ( n  = 13) or the EMG-FES interface on ankle joint training (EF) group ( n  = 13). Subjects in both groups were trained for 20 min a day, 5 times a week, for 4 weeks. Similarly, all participants underwent a standard rehabilitation physical therapy for 60 min a day, 5 times a week, for 4 weeks. The RFEF group showed significant increases in weight-bearing lunge test (WBLT), Tardieu Scale (TS), Timed Up and Go Test (TUG), Berg Balance Scale (BBS), velocity, cadence, step length, stride length, stance per, and swing per ( p <  0.05). Likewise, the EF group showed significant increases in WBLT, TUG, BBS, velocity, and cadence ( p  < 0.05). Moreover, the RFEF group showed significantly greater improvements than the EF group in terms of WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per ( p  < 0.05). Ankle joint training using an EMG-FES interface combined with real-time feedback improved ankle range of motion (ROM), muscle tone, balance, and gait in stroke patients. These results suggest that an EMG-FES interface combined with real-time feedback is feasible and suitable for ankle joint training in individuals with stroke.",2020,"Moreover, the RFEF group showed significantly greater improvements than the EF group in terms of WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per ( p  < 0.05).","['Patients with Stroke Hemiparesis', 'individuals with stroke', 'Twenty-six stroke patients participated in this study', 'stroke patients', 'patients with stroke hemiplegia']","['RFEF', 'electromyography-functional electrical stimulation interface (EMG-FES interface) combined with real-time balance and gait feedback', 'Combined with Real-Time Feedback', 'standard rehabilitation physical therapy', 'EMG-FES interface combined with real-time feedback', 'EMG-FES Interface', 'EMG-FES interface combined with real-time feedback on ankle joint training (RFEF) group ( n  = 13) or the EMG-FES interface on ankle joint training (EF', 'Ankle joint training using an EMG-FES interface combined with real-time feedback']","['Ankle Joint Training', 'WBLT, TUG, BBS, velocity, and cadence', 'WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per', 'Balance and Gait', 'ankle range of motion (ROM), muscle tone, balance, and gait', 'weight-bearing lunge test (WBLT), Tardieu Scale (TS), Timed Up and Go Test (TUG), Berg Balance Scale (BBS), velocity, cadence, step length, stride length, stance per, and swing per']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",,0.0156884,"Moreover, the RFEF group showed significantly greater improvements than the EF group in terms of WBLT, Tardieu Scale, TUG, BBS, velocity, step length, stride length, stance per, and swing per ( p  < 0.05).","[{'ForeName': 'Subeen', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030292']
2523,32847020,A 24-Week Physical Activity Intervention Increases Bone Mineral Content without Changes in Bone Markers in Youth with PWS.,"Bone mineral density (BMD) is of concern in Prader-Willi syndrome (PWS). This study compared responses to a physical activity intervention in bone parameters and remodeling markers in youth with PWS ( n  = 45) and youth with non-syndromic obesity (NSO;  n  = 66). Measurements occurred at baseline (PRE) and after 24 weeks (POST) of a home-based active games intervention with strengthening and jumping exercises (intervention group = I) or after a no-intervention period (control group = C). Dual x-ray absorptiometry scans of the hip and lumbar spine (L1-L4) determined BMD and bone mineral content (BMC). Bone markers included fasting bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide of type I collagen (CTx). Both I and C groups increased their hip BMD and BMC ( p  < 0.001). Youth with PWS-I increased their spine BMC from PRE to POST ( p  < 0.001) but not youth with PWS-C ( p  = 1.000). Youth with NSO (I and C) increased their spine BMC between PRE and POST (all  p  < 0.001). Youth with PWS showed lower BAP (108.28 ± 9.19 vs. 139.07 ± 6.41 U/L;  p  = 0.006) and similar CTx (2.07 ± 0.11 vs.1.84 ± 0.14 ng/dL;  p  = 0.193) than those with NSO regardless of time. Likely, the novelty of the intervention exercises for those with PWS contributed to gains in spine BMC beyond growth. Bone remodeling markers were unaltered by the intervention.",2020,Both I and C groups increased their hip BMD and BMC ( p  < 0.001).,"['youth with PWS ( n  = 45) and youth with non-syndromic obesity (NSO;  n  = 66', 'Youth with NSO ', 'Youth with PWS']","['Physical Activity Intervention', 'physical activity intervention']","['lower BAP', 'Bone mineral density (BMD', 'Bone remodeling markers', 'spine BMC', 'BMD and bone mineral content (BMC', 'hip BMD and BMC', 'fasting bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide of type I collagen (CTx']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0047830', 'cui_str': ""4,4'-thiodianiline""}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C1101784', 'cui_str': 'ICTP peptide'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",,0.0340018,Both I and C groups increased their hip BMD and BMC ( p  < 0.001).,"[{'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Rubin', 'Affiliation': 'Department of Kinesiology, California State University Fullerton, 800 N. State College Blvd., Fullerton, CA 92831, USA.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology, California State University Fullerton, 800 N. State College Blvd., Fullerton, CA 92831, USA.'}, {'ForeName': 'Camila E', 'Initials': 'CE', 'LastName': 'Orsso', 'Affiliation': 'Department of Agricultural, Food, and Nutritional Science, University of Alberta, 8602 112 Street, Edmonton, AB T6G 2E1, Canada.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Gertz', 'Affiliation': 'Obesity and Metabolism Unit, Western Human Nutrition Research Center, U.S. Department of Agriculture, 430 W Health Sciences Drive, Davis, CA 95616, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Haqq', 'Affiliation': 'Department of Agricultural, Food, and Nutritional Science, University of Alberta, 8602 112 Street, Edmonton, AB T6G 2E1, Canada.'}, {'ForeName': 'Diobel M', 'Initials': 'DM', 'LastName': 'Castner', 'Affiliation': 'Department of Kinesiology, California State University Fullerton, 800 N. State College Blvd., Fullerton, CA 92831, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Dumont-Driscoll', 'Affiliation': 'Academic General Pediatrics, University of Florida, Gainesville, 1699 SW 16th Avenue, Gainesville, FL 32608, USA.'}]",Genes,['10.3390/genes11090984']
2524,32847040,"Development and Implementation of a ""Music Beeps"" Program to Promote Physical Fitness in Adolescents.","This study aimed to develop a physical education fitness program for adolescents to counteract the declining physical activity levels caused by the COVID-19 pandemic, as well as to investigate the program's effect. This mixed-methods study developed and implemented a five-component ""Music Beeps"" (MB) program to promote adolescents' physical fitness. A total of 240 students from two high schools in South Korea-divided into experimental and control groups-participated in 32 sessions over 16 weeks. The changes in students' fitness were analyzed, and the educational effects were examined via inductive analysis of the observation logs and group and in-depth interviews. The results demonstrated that, whereas the comparison group demonstrated no statistically significant changes in power, muscular strength and endurance, or cardiopulmonary endurance, the experimental group showed changes in all these variables, along with changes in flexibility. Further, the MB program had significant educational effects. First, students reported that musical cues enhanced their fitness motivation and sense of responsibility. Second, record-keeping and active participation contributed to self-led fitness management. Third, activity in a small space with few pieces of equipment led to the positive perception that the program was efficient and enabled regular exercise regardless of climate conditions.",2020,"The results demonstrated that, whereas the comparison group demonstrated no statistically significant changes in power, muscular strength and endurance, or cardiopulmonary endurance, the experimental group showed changes in all these variables, along with changes in flexibility.","['Adolescents', '240 students from two high schools in South Korea-divided into experimental and control groups-participated in 32 sessions over 16 weeks']","['Music Beeps"" Program', 'physical education fitness program', 'five-component ""Music Beeps"" (MB) program']","['fitness motivation and sense of responsibility', 'power, muscular strength and endurance, or cardiopulmonary endurance', 'physical activity levels', 'flexibility']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",240.0,0.0155391,"The results demonstrated that, whereas the comparison group demonstrated no statistically significant changes in power, muscular strength and endurance, or cardiopulmonary endurance, the experimental group showed changes in all these variables, along with changes in flexibility.","[{'ForeName': 'Hyun-Chul', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Physical Education, Jeonbuk National University High School, Jeollabuk-do 54869, Korea.'}, {'ForeName': 'Eui-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, Baek Seok High School, Goyang-si 10416, Korea.'}, {'ForeName': 'Hyun-Su', 'Initials': 'HS', 'LastName': 'Youn', 'Affiliation': 'Department of Physical Education, College of Education, Won Kwang University, Iksan-si 54538, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17176148']
2525,32847127,Instrumented Four Square Step Test in Adults with Transfemoral Amputation: Test-Retest Reliability and Discriminant Validity between Two Types of Microprocessor Knees.,"Technology-based outcomes have recently been proposed to complement the standard Four Square Step Test (FSST) by providing a decomposition of the sequences and information about the stepping pattern. A test-retest study and a randomized crossover design have been used to determine immediate test-retest reliability and to assess discriminant validity, in persons with a unilateral transfemoral amputation, for the parameters computed by an instrumented version of the Four Square Step Test. Twenty adults, independent and unlimited community ambulators, with a unilateral transfemoral amputation, performed two Four Square Step Tests on a pressure mat first with a microprocessor knee, then, a few weeks later with another one. One of these prosthetic knees was acknowledged to be superior and to provide functional improvement. Test-retest, intraclass correlation coefficients and minimal detectable change at 95% confidence level were calculated for each variable. Paired samples t-tests were then used to identify differences between the two microprocessor knee systems. The test-retest reliability of most outcome measures was good to excellent. Few variables showed a systematic difference and a trend to improve between test 1 and test 2. When comparing both microprocessor knees, significant differences in the expected direction were observed, with interpretation in accordance with a functional improvement. Importantly, we highlighted that various strategies to improve the performance in the test might complexify the interpretation of the most detailed measurement. The instrumented Four Square Step test provides reliable measures with satisfactory test-retest reliability and discriminant validity in persons with unilateral transfemoral amputation.",2020,The instrumented Four Square Step test provides reliable measures with satisfactory test-retest reliability and discriminant validity in persons with unilateral transfemoral amputation.,"['persons with unilateral transfemoral amputation', 'Twenty adults, independent and unlimited community ambulators, with a unilateral transfemoral amputation', 'persons with a unilateral transfemoral amputation', 'Adults with Transfemoral Amputation']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],[],20.0,0.0292959,The instrumented Four Square Step test provides reliable measures with satisfactory test-retest reliability and discriminant validity in persons with unilateral transfemoral amputation.,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gouelle', 'Affiliation': 'ProtoKinetics, Havertown, PA 19083, USA.'}, {'ForeName': 'Michael Jason', 'Initials': 'MJ', 'LastName': 'Highsmith', 'Affiliation': 'School of Physical Therapy & Rehabilitation Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL 33612, USA.'}]","Sensors (Basel, Switzerland)",['10.3390/s20174782']
2526,32847174,The Pyramid Club Primary School-Based Intervention: Evaluating the Impact on Children's Social-Emotional Health.,"BACKGROUND


Children with poor social-emotional health are at risk of failing to reach their potential.
METHOD


The impact of the Pyramid Club year 3 preventive intervention on children's social-emotional health was investigated. Children were allocated to an intervention or non-problem comparison group.
RESULTS


Post-intervention both groups had improved Total Difficulty scores (Strengths and Difficulties Questionnaire) with the Pyramid group showing a significantly stronger effect size (r = .71) than the non-problem comparison group (r = .44).
CONCLUSIONS


The Pyramid Club intervention improves the social-emotional health of vulnerable children. The need to evaluate such interventions and to extend research are discussed.",2008,"RESULTS


Post-intervention both groups had improved Total Difficulty scores (Strengths and Difficulties Questionnaire) with the Pyramid group showing a significantly stronger effect size (r = .71) than the non-problem comparison group (r = .44).
","['Children with poor social-emotional health', ""Children's Social-Emotional Health"", 'vulnerable children']","['Pyramid Club intervention', 'Pyramid Club year 3 preventive intervention', 'intervention or non-problem comparison group']","[""children's social-emotional health"", 'social-emotional health', 'Total Difficulty scores (Strengths and Difficulties Questionnaire']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}]","[{'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",,0.0188017,"RESULTS


Post-intervention both groups had improved Total Difficulty scores (Strengths and Difficulties Questionnaire) with the Pyramid group showing a significantly stronger effect size (r = .71) than the non-problem comparison group (r = .44).
","[{'ForeName': 'Maddie', 'Initials': 'M', 'LastName': 'Ohl', 'Affiliation': ""Department of Psychology, Thames Valley University, St Mary's Road, London, W5 5RF, UK. E-mail: pauline.fox@tvu.ac.uk.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mitchell', 'Affiliation': ""Department of Psychology, Thames Valley University, St Mary's Road, London, W5 5RF, UK. E-mail: pauline.fox@tvu.ac.uk.""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Cassidy', 'Affiliation': 'Department of Psychology, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Fox', 'Affiliation': ""Department of Psychology, Thames Valley University, St Mary's Road, London, W5 5RF, UK. E-mail: pauline.fox@tvu.ac.uk.""}]",Child and adolescent mental health,['10.1111/j.1475-3588.2007.00476.x']
2527,32847217,Preventing Adolescent Depression in Mauritius: A Universal School-Based Program.,"BACKGROUND


This study evaluated the efficacy of a universal prevention program for adolescent depresssion implemented by school teachers in Mauritius.
METHOD


160 adolescents were randomly assigned to the prevention program or wait-list.
RESULTS


Decreased depressive symptoms for the intervention condition were found post-intervention, but not at follow-up. Significant changes in self-esteem and coping skills were seen both post-intervention and at the follow-up.
CONCLUSIONS


The results, drawing from a culturally diverse population, suggest that universal programs such as RAP-A may be better seen as promoting positive mental health, rather than having direct prevention or intervention effects on clinical problems.",2011,"Significant changes in self-esteem and coping skills were seen both post-intervention and at the follow-up.
","['160 adolescents', 'Adolescent Depression in Mauritius', 'adolescent depresssion implemented by school teachers in Mauritius']","['universal prevention program', 'prevention program or wait-list']","['self-esteem and coping skills', 'Decreased depressive symptoms']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",160.0,0.0166949,"Significant changes in self-esteem and coping skills were seen both post-intervention and at the follow-up.
","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rivet-Duval', 'Affiliation': 'School of Psychology (F12), University of Sydney, NSW 2006, Australia. E-mail: caroline@psych.usyd.edu.au.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Heriot', 'Affiliation': 'School of Psychology (F12), University of Sydney, NSW 2006, Australia. E-mail: caroline@psych.usyd.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'School of Psychology (F12), University of Sydney, NSW 2006, Australia. E-mail: caroline@psych.usyd.edu.au.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2010.00584.x']
2528,32847220,Enhancing Adoptive Parenting: A Cost-Effectiveness Analysis.,"BACKGROUND


Children adopted from care often exhibit behavioural difficulties. There is however limited cost-effectiveness evidence regarding different interventions to address this. This paper reports a cost-effectiveness analysis of parenting programmes for these children.
METHOD


Adoptive parents of children aged between 3 and 8 years participated in home-based, manualised, parenting programmes delivered by trained family social workers. The adopters were randomly allocated to one of two interventions (n = 19) or to a 'services as usual' control group (n = 18). Baseline, immediate post-intervention and 6-month follow-ups were assessed by questionnaires and adopter interviews. Economic costs were calculated.
RESULTS


At 6-month follow-up, a significant difference (p < .007) was found for 'satisfaction with parenting' in favour of the intervention group. No significant differences were found on child measures between the combined intervention groups and control group, adjusting for baseline scores. The mean costs for the combined intervention group were £1528 higher than for the control group at the post-intervention point, which was statistically significant (95% CI, £67 to £2782). However, over the entire follow-up period the difference (£1652) was not statistically significant (-£1709 to £4268). The cost-effectiveness analysis showed that costs of £731 would be incurred to achieve a point improvement in satisfaction with parenting compared to routine care by the end of treatment, whilst the figure was £337 for a point improvement by the 6-month follow-up.
CONCLUSIONS


Findings suggest that a home-based parenting programme for adopters caring for difficult children in the first 18 months of placement may be cost-effective in enhancing satisfaction with parenting, but not in reducing child behavioural problems, compared with 'services-as-usual'.",2011,"The mean costs for the combined intervention group were £1528 higher than for the control group at the post-intervention point, which was statistically significant (95% CI, £67 to £2782).","['Adoptive parents of children aged between 3 and 8\u2003years participated in home-based, manualised, parenting programmes delivered by trained family social workers']",['Enhancing Adoptive Parenting'],"['mean costs', 'Economic costs', 'child measures']","[{'cui': 'C0337466', 'cui_str': 'Adoptive parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}]","[{'cui': 'C0337466', 'cui_str': 'Adoptive parent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0314987,"The mean costs for the combined intervention group were £1528 higher than for the control group at the post-intervention point, which was statistically significant (95% CI, £67 to £2782).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sharac', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, King's College London, De Crespigny Park, London SE5 8AF, UK E-mail: paul.mccrone@kcl.ac.uk.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, King's College London, De Crespigny Park, London SE5 8AF, UK E-mail: paul.mccrone@kcl.ac.uk.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rushton', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, King's College London, De Crespigny Park, London SE5 8AF, UK E-mail: paul.mccrone@kcl.ac.uk.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Monck', 'Affiliation': 'Thomas Coram Research Unit, Institute of Education, University of London, 20 Bedford Way, London WC1H 0AL, UK.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2010.00587.x']
2529,32847225,Outcome Findings from a Parent Training Programme for Young People with Conduct Problems.,"BACKGROUND


Group-based parent training programmes are a common intervention for tackling conduct problems in young people. The objective of this study was to evaluate the impact of a parent training programme on young people presenting with conduct problems.
METHOD


123 parents of young people aged 10 to 17 with conduct problems participated in the study. A one-group, pre-post design was adopted. Participants completed the Child Behaviour Check List (CBCL) at the beginning and end of the parenting programme. The degree of change was indexed by: a) Mean change; b) change from clinical to non-clinical status; and c) Reliable change. Logistic regression was used to identify predictors of reliable positive change in CBCL problems.
RESULTS


Analyses from all three sources suggest that there was a significant reduction in CBCL internalising, externalising and total scores. Withdrawn score pre-treatment was the only independent predictor of reliable change in internalising and total scores: the higher the score pre-treatment, the greater the chances of reliable improvement in post-treatment scores.
CONCLUSIONS


The study provides evidence in support of the therapeutic improvement achieved by some young people whose parents attended the group parent training programme. The programme had a significant impact on internalising as well as externalising problems. Further studies of the programme would benefit from being run as a randomised clinical trial.",2011,The study provides evidence in support of the therapeutic improvement achieved by some young people whose parents attended the group parent training programme.,"['young people', 'young people presenting with conduct problems', '123 parents of young people aged 10 to 17 with conduct problems participated in the study', 'Young People with Conduct Problems']",['parent training programme'],"['Child Behaviour Check List (CBCL', 'CBCL internalising, externalising and total scores']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0691536,The study provides evidence in support of the therapeutic improvement achieved by some young people whose parents attended the group parent training programme.,"[{'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Baruch', 'Affiliation': 'Brandon Centre for Counselling and Psychotherapy for Young People, 26 Prince of Wales Road, London NW5 3LG, UK. E-mail: gfbaruch@btconnect.com.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Vrouva', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wells', 'Affiliation': 'Brandon Centre for Counselling and Psychotherapy for Young People, 26 Prince of Wales Road, London NW5 3LG, UK. E-mail: gfbaruch@btconnect.com.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2010.00574.x']
2530,32847264,A randomized controlled pilot study into the effects of a restricted elimination diet on family structure in families with ADHD and ODD.,"BACKGROUND


Behavioural improvements of children with attention-deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) following a restricted elimination diet (RED), may be due to concurrent changes in family environment.
METHODS


Twenty-four children with ADHD, were randomized to either a 5-week RED intervention, or a control intervention consisting of healthy food advices in a pilot study.
RESULTS


No differences in family environment were found, neither at baseline nor when comparing the start and end measurements of both groups.
CONCLUSIONS


In this pilot study, the effects of an RED on ADHD and ODD are not mediated by improvement of family environment in families motivated to follow an RED. Replication of this preliminary study in larger groups of children is advised.",2013,"No differences in family environment were found, neither at baseline nor when comparing the start and end measurements of both groups.
","['families with ADHD and ODD', 'Twenty-four children with ADHD', 'children with attention-deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD']","['RED', 'control intervention consisting of healthy food advices', '5-week RED intervention', 'restricted elimination diet']",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],24.0,0.051211,"No differences in family environment were found, neither at baseline nor when comparing the start and end measurements of both groups.
","[{'ForeName': 'Lidy M', 'Initials': 'LM', 'LastName': 'Pelsser', 'Affiliation': 'ADHD Research Centre, Eindhoven, The Netherlands.'}, {'ForeName': 'Daphne J', 'Initials': 'DJ', 'LastName': 'van Steijn', 'Affiliation': 'Karakter Child and Adolescent Psychiatry University Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Frankena', 'Affiliation': 'Wageningen University, Quantitative Veterinary Epidemiology Group, Wageningen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Toorman', 'Affiliation': 'Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Karakter Child and Adolescent Psychiatry University Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Nanda N', 'Initials': 'NN', 'LastName': 'Rommelse', 'Affiliation': 'Karakter Child and Adolescent Psychiatry University Centre, Nijmegen, The Netherlands.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2012.00652.x']
2531,32847397,Eight Weeks of Device Guided Slow Breathing Decreases Sympathetic Nervous Reactivity to Stress in Post-Traumatic Stress Disorder.,"Posttraumatic stress disorder (PTSD) is characterized by increased risk for developing hypertension and cardiovascular disease. We recently showed that device-guided slow breathing (DGB) acutely lowers blood pressure (BP) and muscle sympathetic activity (MSNA) and improves baroreflex sensitivity (BRS) in PTSD. The aim of this study was to assess the long-term benefits of DGB on autonomic function at rest and during stress. We hypothesized that long-term DGB improves arterial BRS, lower BP and MSNA in PTSD. Twenty-five Veterans with PTSD were studied and randomized to either 8 weeks of daily DGB (n=12) or 8 weeks of Sham device (n=13). BP, heart rate (HR) and MSNA were measured at rest and during mental math. Arterial BRS was assessed using the modified Oxford technique. Resting MSNA, BP and heart rate (HR) remained comparable before and after 8 weeks in both groups (DGB and Sham). Likewise, the change in sympathetic and cardiovagal BRS was not different between the groups. Interestingly, DGB significantly decreased MSNA reactivity to mental math when expressed as burst frequency (P= 0.012) or burst incidence (P= 0.008) compared to sham, suggesting a sustained effect of DGB on sympathetic reactivity to stress in PTSD. Contrary to our hypothesis, long-term DGB did not lower systolic BP, diastolic BP or HR responses to stress compared to sham. Likewise, pulse pressure reactivity after 8 weeks (P= 0.121) was also comparable. In summary, these data suggest that long-term use of DGB may lead to a sustained dampening of sympathetic reactivity to mental stress in PTSD.",2020,"Contrary to our hypothesis, long-term DGB did not lower systolic BP, diastolic BP or HR responses to stress compared to sham.","['Post-Traumatic Stress Disorder', 'Twenty-five Veterans with PTSD', 'Posttraumatic stress disorder (PTSD']","['DGB', 'Device Guided Slow Breathing', 'daily DGB', 'device-guided slow breathing (DGB']","['systolic BP, diastolic BP or HR responses to stress', 'BP, heart rate (HR) and MSNA', 'arterial BRS, lower BP and MSNA', 'MSNA reactivity to mental math', 'Arterial BRS', 'autonomic function', 'Resting MSNA, BP and heart rate (HR', 'Likewise, pulse pressure reactivity', 'sympathetic and cardiovagal BRS', 'blood pressure (BP) and muscle sympathetic activity (MSNA) and improves baroreflex sensitivity (BRS']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",25.0,0.0315964,"Contrary to our hypothesis, long-term DGB did not lower systolic BP, diastolic BP or HR responses to stress compared to sham.","[{'ForeName': 'Ida T', 'Initials': 'IT', 'LastName': 'Fonkoue', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Research Service Line, Atlanta VA Medical Center, Decatur, GA, Unites States.'}, {'ForeName': 'Yingtian', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA, Unites States.'}, {'ForeName': 'Toure', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Research Service Line, Atlanta VA Medical Center, Decatur, GA, Unites States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Vemulapalli', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Research Service Line, Atlanta VA Medical Center, Decatur, GA, Unites States.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Sprick', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Research Service Line, Atlanta VA Medical Center, Decatur, GA, Unites States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rothbaum', 'Affiliation': 'Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Jeanie', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Research Service Line, Atlanta VA Medical Center, Decatur, GA, Unites States.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00079.2020']
2532,32847403,Opening of BK Ca  channels alters cerebral hemodynamic and causes headache in healthy volunteers.,"INTRODUCTION


Preclinical data implicate large conductance calcium-activated potassium (BK Ca ) channels in the pathogenesis of headache and migraine, but the exact role of these channels is still unknown. Here, we investigated whether opening of BK Ca  channels would cause headache and vascular effects in healthy volunteers.
METHODS


In a randomized, double-blind, placebo-controlled, cross-over study, 21 healthy volunteers aged 18-39 years were randomly allocated to receive an intravenous infusion of 0.05 mg/min BK Ca  channel opener MaxiPost and placebo on two different days. The primary endpoints were the difference in incidence of headache and the difference in area under the curve (AUC) for headache intensity scores (0-12 hours) and for middle cerebral artery blood flow velocity (V MCA ) (0-2 hours) between MaxiPost and placebo. The secondary endpoints were the differences in area under the curve for superficial temporal artery and radial artery diameter (0-2 hours) between MaxiPost and placebo.
RESULTS


Twenty participants completed the study. Eighteen participants (90%) developed headache after MaxiPost compared with six (30%) after placebo ( p  = 0.0005); the difference of incidence is 60% (95% confidence interval 36-84%). The area under the curve for headache intensity (AUC 0-12 hours ,  p  = 0.0003), for mean V MCA  (AUC 0-2 hours ,  p  = 0.0001), for superficial temporal artery diameter (AUC 0-2 hours ,  p  = 0.003), and for radial artery diameter (AUC 0-2 hours ,  p  = 0.03) were significantly larger after MaxiPost compared to placebo.
CONCLUSION


MaxiPost caused headache and dilation in extra- and intracerebral arteries. Our findings suggest a possible role of BK Ca  channels in headache pathophysiology in humans. ClinicalTrials.gov, ID: NCT03887325.",2020,"The area under the curve for headache intensity (AUC 0-12 hours ,  p  = 0.0003), for mean V MCA  (AUC 0-2 hours ,  p  = 0.0001), for superficial temporal artery diameter (AUC 0-2 hours ,  p  = 0.003), and for radial artery diameter (AUC 0-2 hours ,  p  = 0.03) were significantly larger after MaxiPost compared to placebo.
","['21 healthy volunteers aged 18-39 years', 'healthy volunteers', 'Twenty participants completed the study']","['intravenous infusion of 0.05\u2009mg/min BK Ca  channel opener MaxiPost and placebo', 'placebo']","['incidence of headache and the difference in area under the curve (AUC) for headache intensity scores (0-12 hours) and for middle cerebral artery blood flow velocity (V MCA ', 'radial artery diameter', 'differences in area under the curve for superficial temporal artery and radial artery diameter', 'headache intensity', 'superficial temporal artery diameter', 'headache and dilation', 'headache after MaxiPost']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439420', 'cui_str': 'mg/min'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C1531444', 'cui_str': 'MaxiPost'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0000325', 'cui_str': '20-Methylcholanthrene'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1531444', 'cui_str': 'MaxiPost'}]",21.0,0.415766,"The area under the curve for headache intensity (AUC 0-12 hours ,  p  = 0.0003), for mean V MCA  (AUC 0-2 hours ,  p  = 0.0001), for superficial temporal artery diameter (AUC 0-2 hours ,  p  = 0.003), and for radial artery diameter (AUC 0-2 hours ,  p  = 0.03) were significantly larger after MaxiPost compared to placebo.
","[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Cherie Amalie Waldorff', 'Initials': 'CAW', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Skandarioon', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Snellman', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lopez-Lopez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jakob Møller', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420940681']
2533,32847423,A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers.,"OBJECTIVES


This study aimed to evaluate the bioequivalence, safety, tolerability and immunogenicity of the biosimilar trastuzumab (SIBP-01) compared to Herceptin®.
METHODS


In this Phase I randomized double-blind parallel-group trial, 100 healthy male volunteers were randomized in a1:1 ratio to receive a single 6 mg•kg-1 intravenous dose of SIBP-01 or Herceptin®. Serum concentrationswere analyzed using a validated ELISA.
RESULTS


The two groups had similar baseline characteristics. The geometric mean ratios (90% CI) of C max , AUC 0-t  and AUC inf  between the trial group and the reference group were 93.55%-104.27%, 91.98%-102.35% and 91.88%-102.34%, respectively; the geometric mean ratios (90% CI) of AUC 0-t  and AUC inf  in the sensitivity analysis were 92.29%-102.63% and 91.81%-102.16%, respectively. These values were within the prespecified equivalence margins, establishing the bioequivalence of SIBP-1 and Herceptin®. AEs were similar across all subjects in the SIBP-01 and Herceptin® arms, with treatment-related AEs reported by 72.00% and 80.00%, respectively. In each group, there was one AE that caused a subject to discontinue the study.
EXPERT OPINION


Trastuzumab (Herceptin®) is significantly more effective than chemotherapy in reducing exacerbations and tumor cell growth, and its adverse events are far lower than chemotherapy. Herceptin®is very expensive for most patients in China. The protein molecular primary structure of the biosimilar trastuzumab (SIBP-01) is consistent with Herceptin®, with highly similar high level structure, biologocal activity and purity.But there are few studies comparing the bioequivalence of SIBP-01 and Herceptin® in healthy subjects and cancer patients.
CONCLUSIONS


This study showed the PK similarity of SIBP-01 to Herceptin®. SIBP-01 was safe and well tolerated in healthy male volunteers, with no significant differences from the reference drug in safety or immunogenicity.",2020,"These values were within the prespecified equivalence margins, establishing the bioequivalence of SIBP-1 and Herceptin®.","['healthy Chinese male volunteers', 'healthy male volunteers', 'patients in China', '100 healthy male volunteers', 'healthy subjects and cancer patients']","['Herceptin®', 'SIBP-01 or Herceptin®', 'biosimilar trastuzumab (SIBP-01', 'potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®', 'Trastuzumab (Herceptin®', 'SIBP-01']","['safety or immunogenicity', 'C max , AUC 0-t  and AUC inf', 'bioequivalence, safety, tolerability and immunogenicity', 'geometric mean ratios', 'safe and well tolerated']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0338204', 'cui_str': 'Herceptin'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",100.0,0.102269,"These values were within the prespecified equivalence margins, establishing the bioequivalence of SIBP-1 and Herceptin®.","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University , Nanjing, Jiangsu, China.'}, {'ForeName': 'Shugang', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'School of Pharmacy, Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'ZhongHuan', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Shan', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Bingyan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Hongju', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University , Nanjing, Jiangsu, China.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2020.1807935']
2534,32847444,Clinical effect of Changweishu on gastrointestinal dysfunction in patients with sepsis.,"OBJECTIVE


To investigate Changweishu's clinical effect on gastrointestinal dysfunction in patients with sepsis.
METHODS


Fifty patients with gastrointestinal dysfunction and sepsis were randomly divided into treatment and control groups. The control group patients received routine Western medicine treatments (meropenem, noradrenaline, glutamine glue,  Bifidobacterium lactis  triple-strain tablet), and the treatment group patients received routine Western medicine treatment combined with Changweishu. Treatments in both groups lasted 7 days. Changes in APACHE II score, gastrointestinal dysfunction score, serum levels of diamine oxidase (DAO), D-lactic acid, inflammatory factors (tumor necrosis factor (TNF)-α, interleukin (IL)-6, and high-mobility group box 1 (HMGB-1)), and the incidence of multiple organ dysfunction syndrome (MODS) and mortality were observed.
RESULTS


After treatment, APACHE II score, gastrointestinal dysfunction score, and DAO, D-lactic acid, TNF-α, IL-6, and HMGB-1 levels decreased significantly in both groups, but the decrease was more significant in the treatment group than in the control group. The incidence of MODS and mortality were significantly lower in the treatment group than in the control group.
CONCLUSION


The addition of Changweishu to routine Western treatments can improve gastrointestinal function in patients with sepsis and gastrointestinal dysfunction, as well as decreasing the incidence of MODS and mortality and improving patient prognosis.",2020,"The addition of Changweishu to routine Western treatments can improve gastrointestinal function in patients with sepsis and gastrointestinal dysfunction, as well as decreasing the incidence of MODS and mortality and improving patient prognosis.","['patients with sepsis', 'Fifty patients with gastrointestinal dysfunction and sepsis', 'patients with sepsis and gastrointestinal dysfunction']","['routine Western medicine treatment combined with Changweishu', 'routine Western medicine treatments (meropenem, noradrenaline, glutamine glue,  Bifidobacterium lactis  triple-strain tablet']","['gastrointestinal function', 'APACHE II score, gastrointestinal dysfunction score, and DAO, D-lactic acid, TNF-α, IL-6, and HMGB-1 levels', 'incidence of MODS and mortality', 'Changes in APACHE II score, gastrointestinal dysfunction score, serum levels of diamine oxidase (DAO), D-lactic acid, inflammatory factors (tumor necrosis factor (TNF)-α, interleukin (IL)-6, and high-mobility group box 1 (HMGB-1)), and the incidence of multiple organ dysfunction syndrome (MODS) and mortality', 'gastrointestinal dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}, {'cui': 'C3658295', 'cui_str': 'Propanoic Acid, 2-Hydroxy-, (2R)-'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0949597', 'cui_str': 'HMG-B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019587', 'cui_str': 'Amine oxidase (copper-containing)'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}]",50.0,0.0141974,"The addition of Changweishu to routine Western treatments can improve gastrointestinal function in patients with sepsis and gastrointestinal dysfunction, as well as decreasing the incidence of MODS and mortality and improving patient prognosis.","[{'ForeName': 'Fen-Qiao', 'Initials': 'FQ', 'LastName': 'Chen', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Wen-Zhong', 'Initials': 'WZ', 'LastName': 'Xu', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Hai-Yun', 'Initials': 'HY', 'LastName': 'Gao', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Wu', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Jian-Qiang', 'Initials': 'JQ', 'LastName': 'Mei', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}]",The Journal of international medical research,['10.1177/0300060520919579']
2535,32847495,Care of family caregivers of persons with dementia (CaFCa) through a tailor-made mobile app: study protocol of a complex intervention study.,"BACKGROUND


Globally, family members account for the main source of caregiving of persons with dementia living at home. Providing care to family members with dementia often has negative health consequences for caregivers such as stress, depression and low quality of life. Yet, formal support for family caregivers (FCs) is limited. Telehealth technology has the potential to provide health care and social support to FCs. This study aims to assess the effectiveness of providing support by healthcare professionals (HPs) through a mobile app in reducing stress, depressive symptoms and loneliness, and improving mental health and quality of life of FCs of persons with dementia.
METHODS


Using a pragmatic intervention design, this study will use pre- and post-intervention assessment to evaluate the effectiveness of the proposed intervention in a sample of 78 FCs of persons with dementia (PWD). The intervention will be implemented by approximately 5 HPs specialized in dementia care based in the municipalities in Sweden. The main thrust of the intervention is to provide professional support, with help of an interactive mobile app, to family members in their caregiving role for PWDs. Qualitative interviews with HPs and FCs form the groundwork of the development of the mobile app. By using the app on smart phone or tablet, the FC, in groups of 8-10, will communicate with peers and a HP exchanging ideas on how to deal with PWD's behavioral and cognitive changes and get support. They will also be able to discuss stressful events and access mindfulness exercises focused on themselves. Quantitative data will be collected before and at three time points after the 8-week intervention to assess changes in the health outcomes of the FCs. In-depth interviews will be conducted after the intervention to capture the experiences of FCs and HPs regarding the ease of use and acceptability of the app.
DISCUSSION


This tailor-made mobile app has the high potential to be a practical platform for supporting FCs to alleviate stress and improve mental health irrespective of distance to the nearest health care or social service center.
TRIAL REGISTRATION


ISRCTN, ISRCTN46137262 . Registered 10 October 2019.",2020,"The main thrust of the intervention is to provide professional support, with help of an interactive mobile app, to family members in their caregiving role for PWDs.","['family caregivers of persons with dementia (CaFCa', 'sample of 78 FCs of persons with dementia (PWD', 'persons with dementia', 'persons with dementia living at home']",['providing support by healthcare professionals (HPs'],"['stress, depressive symptoms and loneliness, and improving mental health and quality of life of FCs']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]",,0.0469358,"The main thrust of the intervention is to provide professional support, with help of an interactive mobile app, to family members in their caregiving role for PWDs.","[{'ForeName': 'Zarina Nahar', 'Initials': 'ZN', 'LastName': 'Kabir', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Alfred Nobels Allé 23, 141 83 Huddinge, Stockholm, Sweden. zarina.kabir@ki.se.'}, {'ForeName': 'Angela Yee Man', 'Initials': 'AYM', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Grundberg', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Alfred Nobels Allé 23, 141 83 Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boström', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Alfred Nobels Allé 23, 141 83 Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lämås', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Kallström', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Alfred Nobels Allé 23, 141 83 Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Moberg', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Alfred Nobels Allé 23, 141 83 Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Berit Seiger', 'Initials': 'BS', 'LastName': 'Cronfalk', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Alfred Nobels Allé 23, 141 83 Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Meijer', 'Affiliation': 'Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Konradsen', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Alfred Nobels Allé 23, 141 83 Huddinge, Stockholm, Sweden.'}]",BMC geriatrics,['10.1186/s12877-020-01712-7']
2536,32843527,PIK3CA mutation in the ShortHER randomized adjuvant trial for patients with early HER2+ breast cancer: association with prognosis and integration with PAM50 subtype.,"PURPOSE


We explored the prognostic effect of PIK3CA mutation in HER2-positive patients enrolled in the ShortHER trial.
EXPERIMENTAL DESIGN


The ShortHER trial randomized 1253 patients with HER2-positive breast cancer to 9-weeks or 1-year of adjuvant trastuzumab combined with chemotherapy. PIK3CA hot-spot mutations in exon 9 and 20 were analysed by Pyrosequencing. Expression of 60 genes, including PAM50 genes was measured using the nCounter platform.
RESULTS


A mutation of the PIK3CA gene was detected in 21.7% of the 803 genotyped tumors. At a median follow up of 7.7 years, 5-yr disease-free survival (DFS) rates were 90.6% for PIK3CA mutated and 86.2% for PIK3CA wild-type tumors (HR 0.84, 95%CI 0.56-1.27, P=0.417). PIK3CA mutation showed a favorable prognostic impact in the PAM50 HER2-enriched subtype (n=232): 5-yr DFS 91.8% vs 76.1% (log-rank P=0.049; HR 0.46 95%CI 0.21-1.02). HER2-enriched/ PIK3CA mutated vs wild-type tumors showed numerically higher tumor infiltrating lymphocytes (TILs) and significant upregulation of immune-related genes (including CD8A, CD274, PDCD1 and MYBL2, a proliferation gene involved in immune processes). High TILs as well as the upregulation of PDCD1 and MYBL2 were associated with a significant DFS improvement within the HER2-enriched subtype (HR 0.82, 95%CI 0.68-0.99, P=0.039 for 10% TILs increment; HR 0.81, 95%CI 0.65-0.99, P=0.049 for PDCD1 expression; HR 0.72, 95%CI 0.53-0.99, P=0.042 for MYBL2 expression).
CONCLUSIONS


PIK3CA mutation showed no prognostic impact in the ShortHER trial. Within the HER2-enriched molecular subtype, patients with PIK3CA mutated tumors showed better DFS vs PIK3CA wild-type that may be partly explained by upregulation of immune-related genes.",2020,"High TILs as well as the upregulation of PDCD1 and MYBL2 were associated with a significant DFS improvement within the HER2-enriched subtype (HR 0.82, 95%CI 0.68-0.99, P=0.039 for 10% TILs increment; HR 0.81, 95%CI 0.65-0.99, P=0.049 for PDCD1 expression; HR 0.72, 95%CI 0.53-0.99, P=0.042 for MYBL2 expression).
","['HER2-positive patients enrolled in the ShortHER trial', 'patients with early HER2+ breast cancer', '1253 patients with HER2-positive breast cancer to 9-weeks or 1-year of adjuvant']","['PIK3CA', 'trastuzumab combined with chemotherapy']","['5-yr disease-free survival (DFS) rates', 'Expression of 60 genes, including PAM50 genes', 'tumor infiltrating lymphocytes (TILs) and significant upregulation of immune-related genes (including CD8A, CD274, PDCD1 and MYBL2, a proliferation gene involved in immune processes']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C1505106', 'cui_str': 'MYBL2 protein, human'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",1253.0,0.164005,"High TILs as well as the upregulation of PDCD1 and MYBL2 were associated with a significant DFS improvement within the HER2-enriched subtype (HR 0.82, 95%CI 0.68-0.99, P=0.039 for 10% TILs increment; HR 0.81, 95%CI 0.65-0.99, P=0.049 for PDCD1 expression; HR 0.72, 95%CI 0.53-0.99, P=0.042 for MYBL2 expression).
","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Surgery, Oncology and Gastroeneterology, University of Padova, Istituto oncologico Veneto IRCCS.'}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Dieci', 'Affiliation': 'Surgery, Oncology and Gastroenterology, University of Padova, Istituto oncologico Veneto IRCCS mariavittoria.dieci@unipd.it.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Bisagni', 'Affiliation': 'Department of Oncology, Santa Maria Nuova Hospital.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology, AUSL.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Frassoldati', 'Affiliation': 'Arcispedale S. Anna"", Ferrara.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Medical Oncology Unit, Ospedale di Piacenza.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Musolino', 'Affiliation': 'Medical Oncology and Breast Unit, University Hospital of Parma.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Department of Medical Oncology , ""Giovanni Paolo II"" Institute, Bari, Italy.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Rimanti', 'Affiliation': 'Azienda Ospedaliera di Mantova.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Garrone', 'Affiliation': 'Medical Oncology, S. Croce e Carle Ospedale di Insegnamento.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bertone', 'Affiliation': 'Ospedale S. Anna.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Cagossi', 'Affiliation': 'Medical Oncology, Ramazzini Hospital.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Nanni', 'Affiliation': 'Biostatistic and Clinical Trials Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Piacentini', 'Affiliation': 'Dept. of Medical and Surgical Sciences for Children and Adults, Modena University Hospital.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Orvieto', 'Affiliation': 'Pathology Unit, Ulss 5 Polesana.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Griguolo', 'Affiliation': 'Department of Surgery, Oncology and Gastroeneterology, University of Padua.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Curtarello', 'Affiliation': 'Immunologia e Diagnostica Molecolare Oncologica, Istituto Oncologico Veneto.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Urso', 'Affiliation': 'Second Medical Oncology Unit, Istituto Oncologico Veneto.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI breast cancer research group.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Chic', 'Affiliation': 'Medical Oncology Department, Hospital Clínic.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Hematology, Oncology and Respiratory Diseases, University of Modena and Reggio Emilia.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Department of Medical Oncology, Hospital Clinic de Barcelona.'}, {'ForeName': 'PierFranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Medical Oncology 2, University of Padova, Istituto Oncologico Veneto IRCCS.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1731']
2537,32843786,"Comparative Evaluation of McGrath MAC, Truview Video Laryngoscopes and Macintosh Laryngoscope for Endotracheal Intubation in Patients Undergoing Surgery under General Anaesthesia.","Background


Videolaryngoscopy is a newly developed technique to improve tracheal intubation success. It was made to bypass the need of directly visualising the glottic inlet. These devices are advantageous as there is no need of aligning the laryngeal, pharyngeal and oral axes for a clear view, thus making intubation easier and faster.
Aim and Objectives


Primary objective of the study was to determine the duration of laryngoscopy and intubation and Cormack - Lehane grading when intubating with McGrath MAC, Truview video laryngoscope and Macintosh laryngoscope. Secondary objectives of the study were to determine the number of attempts and optimization manouveres required to intubate.
Materials and Methods


This study was conducted on total of 120 patients in age 20-70 years, either sex, with American Society of Anaesthesiologists physical status classes I or II scheduled for elective surgery under general anaesthesia. They were randomly assigned equally to group 1, 2 and 3 ( n  = 40) to be intubated by Mcgrath MAC video laryngoscope, Truview video laryngoscope and Macintosh laryngoscope respectively. Parameters recorded were duration of laryngoscopy and intubation, Cormack Lahane grading, ease of intubation, number of attempts and optimisation manouveres required for intubation.
Statistical Analysis


Comparison of mean value among the three groups was done using student t test and percentage comparison was done using chi square test. To compare more than two variables ANOVA test was used. The  P  values of less than 0.05 was considered statistically significant.
Results


Duration of laryngoscopy was significantly less in McGrath MAC group when compared to Truview group ( P  = 0.02) and to Macintosh group ( P  < 0.001) and the duration of intubation was comparable among all three study groups ( P  > 0.05). The difference in Cormack - Lehane grading was not significant between McGgrath MAC and Trueview ( P  = 0.71) but was significant between McGrath MAC and Macintosh ( P  = 0.002) and Trueview and Macintosh ( P  = 0.002). Ease of intubation was better in McGrath MAC and Truview groups compared to Macintosh group ( P  < 0.05). Intubation was successful in the first attempt in 39 (97.50%) patients in McGrath MAC group, 40 (100%) patients in Truview group and 35 (87.50%) patients in Macintosh group. McGrath MAC and Truview groups performed better with respect to optimization manoeuvres compared to Macintosh group ( P  < 0.05). Trauma was observed in 2 (5%) patients in Truview group and 5 (12.50%) patients in Macintosh group. In McGrath MAC group, no patient underwent any trauma.
Conclusion


Although duration of laryngoscopy was significantly shorter in McGrath as compared to Truview video laryngoscope and Macintosh laryngoscope but the duration of intubation was comparable between the three groups. Both these video laryngoscopes performed significantly better than Macintosh laryngoscope with respect to laryngoscopic view, requirement of optimization manoeuvre and need for second attempt for intubation.",2020,"Both these video laryngoscopes performed significantly better than Macintosh laryngoscope with respect to laryngoscopic view, requirement of optimization manoeuvre and need for second attempt for intubation.","['120 patients in age 20-70 years, either sex, with American Society of Anaesthesiologists physical status classes', 'Patients Undergoing Surgery under General Anaesthesia']","['elective surgery under general anaesthesia', 'intubated by Mcgrath MAC video laryngoscope, Truview video laryngoscope and Macintosh laryngoscope respectively', 'McGrath MAC, Truview Video Laryngoscopes and Macintosh Laryngoscope', 'McGrath MAC, Truview video laryngoscope and Macintosh laryngoscope']","['duration of laryngoscopy', 'Trauma', 'Duration of laryngoscopy', 'tracheal intubation success', 'duration of laryngoscopy and intubation, Cormack Lahane grading, ease of intubation, number of attempts and optimisation manouveres required for intubation', 'duration of intubation', 'number of attempts and optimization manouveres required to intubate']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",120.0,0.0386345,"Both these video laryngoscopes performed significantly better than Macintosh laryngoscope with respect to laryngoscopic view, requirement of optimization manoeuvre and need for second attempt for intubation.","[{'ForeName': 'Gurleen', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Sunana', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Acharya Shri Chander College of Medical Sciences and Hospital, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mehta', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Acharya Shri Chander College of Medical Sciences and Hospital, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Jatanbir Singh', 'Initials': 'JS', 'LastName': 'Dhingra', 'Affiliation': 'Dhingra Child Care Center, Ludhiana, Punjab, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_16_20']
2538,32843788,Comparison of Paravertebral Block with Conventional Spinal Anesthesia in Patients Undergoing Unilateral Inguinal Hernia Repair.,"Context


Although spinal anesthesia (also known as subarachnoid block [SAB]) is used widely for inguinal hernia repair, the paravertebral block (PVB) that produces unilateral, segmental analgesia is used with a high success rate in inguinal hernia repair.
Aims


The aim of the study was to compare SAB and PVB in inguinal hernia repair, in terms of the duration of postoperative analgesia and adverse events.
Settings and Design


This was a prospective, randomized, controlled double-blind study.
Methods


This study was done on 60 male patients of American Society of Anesthesiology (ASA) I and II. Patients were categorized into 30 in each group, either to receive PVB block at two levels T10 and L1 using 15 mL and 5 mL of 0.5% bupivacaine and 1 μg.kg -1  of buprenorphine or SAB with 12.5 mg of 0.5% hyperbaric bupivacaine injected intrathecally.
Statistical Analysis Used


SPSS 18.0 and R version 3.2.2 were used for analyzing the data. Categorical measurements were presented in number (%) and analyzed using Chi-square/Fischer's exact test. Continuous measurements were analyzed using Student's  t -test.
Results


Age, weight, height, and ASA status were comparable in both the groups. In the PVB group, eight patients had failure of block. Hemodynamic responses, time to first analgesia and ambulation, time required to perform the block, Bromage score, satisfaction score, failure rate, and intra- and postoperative drugs used showed a statistically significant difference between the groups ( P  < 0.001).
Conclusion


PVB is not a sole anesthetic technique due to a higher failure rate and increased intraoperative fentanyl requirement but has advantages such as prolonged analgesia, stable hemodynamics, and early ambulation.",2020,ASA status were comparable in both the groups.,"['60 male patients of American Society of Anesthesiology (ASA) I and II', 'Patients Undergoing Unilateral Inguinal Hernia Repair']","['buprenorphine or SAB with 12.5 mg of 0.5% hyperbaric bupivacaine injected intrathecally', 'spinal anesthesia', 'Paravertebral Block with Conventional Spinal Anesthesia', 'PVB block at two levels T10 and L1 using 15 mL and 5 mL of 0.5% bupivacaine']","['failure of block', 'ASA status', 'Hemodynamic responses, time to first analgesia and ambulation, time required to perform the block, Bromage score, satisfaction score, failure rate, and intra- and postoperative drugs']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",60.0,0.162205,ASA status were comparable in both the groups.,"[{'ForeName': 'K Roopa', 'Initials': 'KR', 'LastName': 'Rani', 'Affiliation': 'Department of Anesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vaishnavi', 'Affiliation': 'Department of Anesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Vikas', 'Affiliation': 'Department of Anesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Ashok', 'Affiliation': 'Department of Anesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_19_20']
2539,32843790,Comparison of Duration of Analgesic Comparison of Duration of Analgesic Effect of Nalbuphine and Morphine as an Adjuvant to Bupivacaine in the Supraclavicular Block under Ultrasound Guidance.,"Background


Although many studies are available in the literature that has analyzed the effects of morphine, nalbuphine, and other opioids, no study had compared the effects of nalbuphine versus morphine as an adjuvant to bupivacaine in the supraclavicular block under the guidance of ultrasound.
Methodology


A randomized, double-blinded, prospective study was carried out on 60 patients of the American Society of Anesthesiologists Class I and II who were undergoing upper limb surgeries under the supraclavicular block. Patients were randomly allocated into two groups ( n  = 30). Group  N  received 20 ml of 0.5% bupivacaine with 50 μg.kg -1  of nalbuphine, while Group M received 20 ml of 0.5% bupivacaine with 50 μg.kg -1  of morphine. The characteristics of sensory and motor blocks, hemodynamic changes, duration of analgesia, adverse effects, and analgesic requirements were studied at different time intervals.
Results


In Group N, there was a statistically significant reduction in the time of onset of sensory block (9.9 ± 3.0 vs. 12.2 ± 2.6 min,  P  = 0.002) and motor block (14.4 ± 3.6 vs. 19.4 ± 3.6 min,  P  = 0.0005). The duration of sensory and motor blockade and duration of analgesia were comparable. There was no statistically significant difference regarding block characteristics and hemodynamic parameters.
Conclusion


Nalbuphine when added to bupivacaine as an adjuvant had significantly shortened the time of onset of sensory and motor blockade than morphine. However, the duration of analgesia, sensory and motor blockade of nalbuphine versus morphine were comparable.",2020,"There was no statistically significant difference regarding block characteristics and hemodynamic parameters.
","['60 patients of the American Society of Anesthesiologists Class I and II who were undergoing upper limb surgeries under the supraclavicular block', 'Supraclavicular Block under Ultrasound Guidance']","['nalbuphine versus morphine', 'Bupivacaine', 'bupivacaine', 'Nalbuphine and Morphine', 'nalbuphine, while Group M received 20 ml of 0.5% bupivacaine', 'morphine', '20 ml of 0.5% bupivacaine']","['characteristics of sensory and motor blocks, hemodynamic changes, duration of analgesia, adverse effects, and analgesic requirements', 'time of onset of sensory block', 'duration of sensory and motor blockade and duration of analgesia', 'duration of analgesia, sensory and motor blockade of nalbuphine versus morphine', 'time of onset of sensory and motor blockade', 'motor block']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0441847', 'cui_str': 'Group M'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",60.0,0.183791,"There was no statistically significant difference regarding block characteristics and hemodynamic parameters.
","[{'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Vengadessane', 'Affiliation': 'Department of Anesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry, India.'}, {'ForeName': 'Jayashri Devi', 'Initials': 'JD', 'LastName': 'Rajaraman', 'Affiliation': 'Department of Anesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry, India.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Anesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry, India.'}, {'ForeName': 'R Krishna', 'Initials': 'RK', 'LastName': 'Prabu', 'Affiliation': 'Department of Anesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry, India.'}, {'ForeName': 'Srilekha', 'Initials': 'S', 'LastName': 'Damodaran', 'Affiliation': 'Department of Anesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry, India.'}, {'ForeName': 'Britto', 'Initials': 'B', 'LastName': 'Sabu', 'Affiliation': 'Department of Anesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_13_20']
2540,32843791,Evaluation of Gastric Emptying by Ultrasonography after Recommended Fasting Period and Administration of Prokinetic in End-stage Renal Disease Patients.,"Background


Delayed gastric emptying is observed in end-stage renal disease (ESRD).
Aims


Evaluation of gastric emptying after recommended fasting period and on oral administration of prokinetic in ESRD patients using ultrasonography (USG).
Settings and Design


Randomized, double-blind, prospective, controlled study.
Materials and Methods


After institutional ethics committee approval, 200 patients were divided randomly into two equal groups. Three sessions of USG evaluation of gastric antrum were done in supine and right lateral position for assessing gastric emptying, first at 8 am, second after the light meal at 8.30 am, and third after 6 h of light meal. Group A received placebo (sugar-coated pill) and Group B received tablet metoclopramide hydrochloride 10 mg after second session of USG. In each session, measurement of anteroposterior and craniocaudal diameters of gastric antrum was done, and then cross-sectional area was estimated. Three-point grading system (Perlas) was used to perform qualitative evaluation.
Statistical Analysis


Comparison of normally distributed continuous variables was performed using Student's  t -test. Nominal categorical data were compared using Chi-squared test. Nonnormal distribution continuous variables were compared using Mann-Whitney U-test.
Results


6 h of fasting after light meal showed that Group A only had 14% incidence of complete gastric emptying, whereas Group B had 71% as compared by Perlas grading. Gastric antral cross-sectional area measured both in supine (480.89 ± 84.92) and right lateral (575.40 ± 92.62) position of Group A was more than Group B supine (394.15 ± 62.80) and right lateral (470.25 ± 73.63) position ( P  < 0.05).
Conclusion


USG of ESRD patients preoperatively can evaluate gastric contents to assess risk of pulmonary aspiration and guide anesthetic management. Metoclopramide is a good drug to enhance gastric emptying in ESRD patients within the recommended fasting period.",2020,"Gastric antral cross-sectional area measured both in supine (480.89 ± 84.92) and right lateral (575.40 ± 92.62) position of Group A was more than Group B supine (394.15 ± 62.80) and right lateral (470.25 ± 73.63) position ( P  < 0.05).
","['ESRD patients within the recommended fasting period', '200 patients', 'End-stage Renal Disease Patients', 'ESRD patients using ultrasonography (USG']","['Metoclopramide', 'placebo (sugar-coated pill) and Group B received tablet metoclopramide hydrochloride', 'Prokinetic']","['Gastric antral cross-sectional area', 'complete gastric emptying', 'gastric emptying', '\n\n\nDelayed gastric emptying']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0887128', 'cui_str': 'Metoclopramide hydrochloride'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}]",200.0,0.0573585,"Gastric antral cross-sectional area measured both in supine (480.89 ± 84.92) and right lateral (575.40 ± 92.62) position of Group A was more than Group B supine (394.15 ± 62.80) and right lateral (470.25 ± 73.63) position ( P  < 0.05).
","[{'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Abhimanyu Singh', 'Initials': 'AS', 'LastName': 'Pokhriyal', 'Affiliation': 'Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Jindal', 'Affiliation': 'Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Sarpal', 'Affiliation': 'Department of Urology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Radiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_18_20']
2541,32843796,To Compare the Changes in Hemodynamic Parameters and Blood Loss during Percutaneous Nephrolithotomy - General Anesthesia versus Subarachnoid Block.,"Background


Percutaneous nephrolithotomy (PCNL) is done under general anesthesia (GA) in most of the centers. However, associated complications and cost are higher for GA than for regional anesthesia.
Aim


The aim of the study was to compare the efficacy of GA versus subarachnoid block (SAB) with regard to intraoperative blood loss and postoperative drop in hemoglobin (Hb) in patients undergoing PCNL.
Setting and Design


This prospective, randomized, comparative clinical trial was carried out at a tertiary care hospital. After obtaining the institute ethical committee clearance (vide no 57/15), patients were randomly allocated into two groups using table of randomization ( n  = 30 each), Group A - GA, Group B - SAB.
Materials and Methods


Intraoperative blood loss was assessed by measuring the Hb of irrigated fluid and postoperative drop in Hb concentration. Other parameters such as intraoperative mean arterial pressure and heart rate were also compared in these groups.
Statistical Analysis


The results are presented in frequencies, percentages, and mean ± standard deviation. The Chi-square test was used to compare the categorical variables between the groups. Unpaired  t -test was used to compare the continuous variables between the groups.
Results


Hemodynamic parameters were similar in both the groups preoperatively. The Hb drop was significant in Group A (1.28 ± 0.35 g.dl -1 ) as compared to Group B (1.10 ± 0.67 g.dl -1 ). On calculating Hb in irrigated fluid-blood mixture, it was found to be significantly higher in Group A (1.87 ± 0.44 g.L -1 ) as compared to Group B (1.25 ± 0.25 g.L -1 ).
Conclusions


Both GA and SAB are effective and safe in PCNL. However, SAB is associated with less blood loss as estimated by intraoperative blood loss and Hb drop.",2020,The Hb drop was significant in Group A (1.28 ± 0.35 g.dl -1 ) as compared to Group B (1.10 ± 0.67 g.dl -1 ).,['patients undergoing PCNL'],"['\n\n\nPercutaneous nephrolithotomy (PCNL', 'GA versus subarachnoid block (SAB', 'Percutaneous Nephrolithotomy - General Anesthesia versus Subarachnoid Block']","['Hemodynamic Parameters and Blood Loss', 'intraoperative mean arterial pressure and heart rate', 'blood loss', 'Hemodynamic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0852068,The Hb drop was significant in Group A (1.28 ± 0.35 g.dl -1 ) as compared to Group B (1.10 ± 0.67 g.dl -1 ).,"[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Ranjan', 'Affiliation': 'Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Malviya', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Soumya Sankar', 'Initials': 'SS', 'LastName': 'Nath', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_14_20']
2542,32843798,Comparison of Orotracheal versus Nasotracheal Fiberoptic Intubation Using Hemodynamic Parameters in Patients with Anticipated Difficult Airway.,"Background


Both nasal and oral routes can be used for fiberoptic intubation. Often it leads to hemodynamic disturbances, which may have a significant effect in patients with limited cardiopulmonary reserve as well as with cerebrovascular diseases.
Aims


The aim of the study was to evaluate whether there is a clinically relevant difference between the circulatory responses to oral and nasal fiberoptic intubation.
Settings and Design


This was a prospective, randomized, and comparative study.
Materials and Methods


In this study, a total of 90 patients with the American Society of Anesthesiologist physical status I and II of either sex in the age group of 18-60 years and having anticipated difficult airway (DA) posted for elective surgery under general anesthesia were randomly allocated into two groups. Patients underwent fiberoptic intubation via either oral or nasal route under sevoflurane anesthesia with bispectral index guidance. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), time taken to intubation, and need of maneuver were measured.
Statistical Analysis Used


All the analyses were carried out on SPSS 16.0 version (Inc., Chicago, USA). Mean and standard deviation were calculated. The test of analysis between two groups was done by unpaired  t -test.
Results


Demographic and DA characteristics were similar in both the groups. Significantly ( P  < 0.01) lesser alteration in HR, SBP, DBP, and MAP was seen in oral fiberoptic intubation when compared to nasal fiberoptic intubation in the early phase of postintubation. Time taken to intubation was also significantly ( P  < 0.01) lesser in the oral route compared to the nasal route.
Conclusions


Oral fiberoptic intubation causes less hemodynamic alteration and takes less time in comparison to nasal fiberoptic intubation.",2020,Time taken to intubation was also significantly ( P  < 0.01),"['Patients with Anticipated Difficult Airway', '90 patients with the American Society of Anesthesiologist physical status I and II of either sex in the age group of 18-60 years and having anticipated difficult airway (DA) posted for elective surgery under general anesthesia']","['Oral fiberoptic intubation', 'nasal fiberoptic intubation', 'fiberoptic intubation via either oral or nasal route under sevoflurane anesthesia with bispectral index guidance', 'Orotracheal versus Nasotracheal Fiberoptic Intubation']","['Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), time taken to intubation, and need of maneuver were measured', 'Mean and standard deviation', 'alteration in HR, SBP, DBP, and MAP', 'Time taken to intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1522019', 'cui_str': 'Nasal route'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0472581', 'cui_str': 'Nasotracheal fiberoptic intubation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}]",90.0,0.0368658,Time taken to intubation was also significantly ( P  < 0.01),"[{'ForeName': 'Jitendra Singh', 'Initials': 'JS', 'LastName': 'Chahar', 'Affiliation': 'Department of Critical Care Medicine, SGPGIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Pravin Kumar', 'Initials': 'PK', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Rakesh K', 'Initials': 'RK', 'LastName': 'Dubey', 'Affiliation': 'Department of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Malviya', 'Affiliation': 'Department of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Harjai', 'Affiliation': 'Department of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'Department of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_6_20']
2543,32843797,"Comparative Study of Effects of Intraoperative Use of Positive End-Expiratory Pressure, Intermittent Recruitment Maneuver, and Conventional Ventilation on Pulmonary Functions during long-Duration Laparotomy.","Background


With an increase in the duration of general anesthesia, there is a gradual deterioration in pulmonary functions. Intraoperative atelectasis is the major cause of deterioration in pulmonary functions. This study was performed to compare and determine the best ventilatory strategy among conventional ventilation, application of positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver.
Materials and Methods


Seventy-five patients were divided into three groups each of 25 patients. In the first group (zero positive end-expiratory pressure [ZEEP]), we have applied zero PEEP intraoperatively. In the second group (PEEP), we have applied PEEP of 6 cm of H 2 O. In the third group (intermittent lung recruitment maneuver [IRM]), we have done intermittent recruitment maneuver intraoperatively. Pulmonary functions were analyzed by partial pressure of oxygen (PaO 2 )/fraction of inspired oxygen (FiO 2 ) ratio (P/F) and static lung compliance (C stat) .
Results


While comparing the mean P/F ratio between the groups, a significant decrease in P/F ratio of the ZEEP group was found from 90 min after induction up till the end (i. e. 24 h after extubation) of our observations as compared to both the PEEP and IRM groups. However, it did not differ ( P  > 0.05) between the PEEP and IRM groups at all time points on statistical analysis. On comparing the mean of C stat  between the groups, there was a significant decrease in lung compliance of the ZEEP group as compared to both the PEEP and IRM groups at all time points. However, like P/F ratio, compliance was also found to be statistically insignificant between the PEEP and IRM groups.
Conclusions


Pulmonary functions are relatively preserved with application of either PEEP or doing intermittent recruitment maneuver.",2020,"However, it did not differ ( P  > 0.05) between the PEEP and IRM groups at all time points on statistical analysis.",['Materials and Methods\n\n\nSeventy-five patients were divided into three groups each of 25 patients'],"['conventional ventilation, application of positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver', 'Positive End-Expiratory Pressure, Intermittent Recruitment Maneuver, and Conventional Ventilation', 'ZEEP', 'third group (intermittent lung recruitment maneuver [IRM']","['mean of C stat', 'lung compliance', 'P/F ratio', 'partial pressure of oxygen (PaO 2 )/fraction of inspired oxygen (FiO 2 ) ratio (P/F) and static lung compliance (C stat) ', 'Pulmonary Functions', 'mean P/F ratio']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0024112', 'cui_str': 'Lung compliance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",75.0,0.0214422,"However, it did not differ ( P  > 0.05) between the PEEP and IRM groups at all time points on statistical analysis.","[{'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Deparment of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Pravin Kumar', 'Initials': 'PK', 'LastName': 'Das', 'Affiliation': 'Deparment of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Soumya S', 'Initials': 'SS', 'LastName': 'Nath', 'Affiliation': 'Deparment of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Deparment of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Chauhan', 'Affiliation': 'Department of Gastrosurgery, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Malviya', 'Affiliation': 'Deparment of Anaesthesiology, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_12_20']
2544,32843800,Comparative Study of Retrobulbar Block versus Ketamine Infusion during Eye Enucleation/Evisceration (Randomized Controlled Trial).,"Background


The aim of this study is to compare the safety and efficacy of retrobulbar block versus intraoperative ketamine infusion in eye enucleation or evisceration under general anesthesia.
Materials and Methods


Forty-five patients belonging to American Society of Anesthesiologists Physical Status I and II undergoing eye enucleation or evisceration were randomly allocated to three equal groups (15 patients each). General anesthesia was used as the standardized technique in all patients. Group R received a single retrobulbar injection, Group K received intravenous ketamine infusion, and Group C received normal saline with the same rate of ketamine infusion. Intraoperative heart rate and mean arterial pressure, recovery time, postoperative pain score, time to first rescue analgesic, number of patients who required rescue analgesia, and any adverse events were reported.
Results


Postoperative pain Visual Analog Scale was significantly lower in R and K groups in comparison to the C group and was significantly higher in K than R group at 3, 6, 12, and 24 h. In addition, the time to first rescue analgesic was significantly longer in R group (429 ± 54 min) than that in K group (272 ± 34 min), but compared to both groups, it was longer in C group (52 ± 7 min). In K group, the recovery time was longer with higher sedation score in comparison to the other two groups.
Conclusions


Single retrobulbar injection and low-dose ketamine infusion are safe and effective when used as adjuvants to general anesthesia, but retrobulbar block provides better control of postoperative pain with prolonged time to first rescue analgesic and reduced analgesic consumption.",2020,"Results


Postoperative pain Visual Analog Scale was significantly lower in R and K groups in comparison to the C group and was significantly higher in K than R group at 3, 6, 12, and 24 h.",['Materials and Methods\n\n\nForty-five patients belonging to American Society of Anesthesiologists Physical Status I and II undergoing eye enucleation or evisceration'],"['retrobulbar block versus intraoperative ketamine infusion', 'Ketamine', 'ketamine', 'Retrobulbar Block', 'ketamine infusion', 'normal saline']","['Intraoperative heart rate and mean arterial pressure, recovery time, postoperative pain score, time to first rescue analgesic, number of patients who required rescue analgesia, and any adverse events', 'recovery time', 'safety and efficacy', 'Postoperative pain Visual Analog Scale', 'time to first rescue analgesic']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015400', 'cui_str': 'Enucleation of eyeball'}, {'cui': 'C0015258', 'cui_str': 'Evisceration - action'}]","[{'cui': 'C0583005', 'cui_str': 'Retrobulbar infiltration of local anesthetic'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0769556,"Results


Postoperative pain Visual Analog Scale was significantly lower in R and K groups in comparison to the C group and was significantly higher in K than R group at 3, 6, 12, and 24 h.","[{'ForeName': 'Hassan Mohamed', 'Initials': 'HM', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Elbadawy', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_146_19']
2545,32843804,"Erector Spinae Plane Block in Laparoscopic Cholecystectomy, Is There a Difference? A Randomized Controlled Trial.","Background


The ultrasound (US)-guided erector spinae plane (ESP) block and oblique subcostal transversus abdominis plane (OSTAP) block are used to decrease postoperative pain and subsequently opioids consumption.
Aim


The aim was to test the hypothesis that US-guided ESP blocks can produce more reduction in opioid usage during the first 24 h after laparoscopic cholecystectomy when compared to OSTAP block.
Settings and Design


Seventy adult patients (20-60 years old) who were planned to undergo elective laparoscopic cholecystectomy were allocated in three groups in randomized controlled trial.
Materials and Methods


The three groups received either port site infiltration, US-guided bilateral ESP block (ESP group), or OSTAP (OSTAP group) with bupivacaine hydrochloride 0.25%.
Statistical Analysis


Postoperative 24 h Morphine consumption, visual analogue scale (VAS), the intraoperative fentanyl (μg) and equivalent morphine dose in the recovery unit were recorded and analyzed using one-way analysis of variance.
Results


The mean 24-h morphine consumption was statistically significant between groups ( P  < 0.001), but it was insignificant between ESP and OSTAP ( P  = 0.173). Median (range) and interquartile range of intraoperatively consumed fentanyl showed significance between the three groups ( P  < 0.001). There was insignificance between ESP block Group II and OSTAP block Group III ( P  = 0.95) by  post hoc  analysis. The mean values of VAS at both rest and movement of the control group were significantly higher than the ESP block group at 6 and 12 h postoperative.
Conclusion


Bilateral US-guided ESP block was found to be as effective as bilateral US OSTAP block. There was more decrease in intraoperative rescue fentanyl, PACU morphine analgesia, 24-h morphine, and pain assessment score in both groups than the control port-site infiltration group.Clinical trial registration number: NCT03398564.",2020,"There was more decrease in intraoperative rescue fentanyl, PACU morphine analgesia, 24-h morphine, and pain assessment score in both groups than the control port-site infiltration group.",['Seventy adult patients (20-60 years old) who were planned to undergo'],"['Laparoscopic Cholecystectomy', 'elective laparoscopic cholecystectomy', 'port site infiltration, US-guided bilateral ESP block (ESP group), or OSTAP (OSTAP group) with bupivacaine hydrochloride 0.25', '\n\n\nThe ultrasound (US)-guided erector spinae plane (ESP) block and oblique subcostal transversus abdominis plane']","['intraoperative rescue fentanyl, PACU morphine analgesia, 24-h morphine, and pain assessment score', 'Statistical Analysis\n\n\nPostoperative 24 h Morphine consumption, visual analogue scale (VAS), the intraoperative fentanyl (μg) and equivalent morphine dose in the recovery unit', 'mean values of VAS', 'Median (range) and interquartile range', 'mean 24-h morphine consumption', 'postoperative pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C4517443', 'cui_str': '0.25'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4075638', 'cui_str': 'Recovery unit'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",70.0,0.0900422,"There was more decrease in intraoperative rescue fentanyl, PACU morphine analgesia, 24-h morphine, and pain assessment score in both groups than the control port-site infiltration group.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_144_19']
2546,32843806,Efficacy of Ultrasound-Guided Caudal Epidural Calcitonin for Patients with Failed Back Surgery Syndrome.,"Context


Pain resulting from failed back surgery syndrome (FBSS) is generally resistant to physiotherapy and pharmacological treatment.
Objective


The aim of this study is to evaluate the effect of adding calcitonin to local anesthetic and steroids during ultrasound-guided caudal epidural injection for patients suffering from FBSS.
Patients and Methods


Fifty-six patients were randomly allocated into two equal groups. All patients underwent ultrasound-guided caudal epidural injection. Group A received 40 mg (1 mL) methylprednisolone +9 mL lidocaine 0.5% + 1500 iu hyaluronidase in 10 mL normal saline, whereas Group B received 40 mg (1 mL) methylprednisolone +9 mL of 0.5% lidocaine + 1500 iu hyaluronidase in 5 mL normal saline + 50 iu calcitonin in 5 mL normal saline.
Results


A statistically significant decrease in visual analog scale, Oswestry Disability Index, and analgesic consumption was recorded in Group B as compared to Group A at 1, 2, and 3 months interval. No side effects were reported in Group A, whereas patients belong to Group B experienced nausea (2 cases), and diuresis for 24 h was detected in two cases.
Conclusion


The addition of calcitonin to epidural steroid and local anesthetic injection resulted in better Oswestry disability scale, diminished pain intensity, and less analgesic consumption.",2020,"A statistically significant decrease in visual analog scale, Oswestry Disability Index, and analgesic consumption was recorded in Group B as compared to Group A at 1, 2, and 3 months interval.","['Patients and Methods\n\n\nFifty-six patients', 'patients suffering from FBSS', 'Patients with Failed Back Surgery Syndrome']","['methylprednisolone +9 mL of 0.5% lidocaine + 1500 iu hyaluronidase in 5 mL normal saline + 50 iu calcitonin in 5 mL normal saline', 'calcitonin to epidural steroid and local anesthetic injection', 'calcitonin to local anesthetic and steroids during ultrasound-guided caudal epidural injection', 'methylprednisolone +9 mL lidocaine 0.5% + 1500 iu hyaluronidase in 10 mL normal saline', 'ultrasound-guided caudal epidural injection', 'Ultrasound-Guided Caudal Epidural Calcitonin']","['diuresis', 'Oswestry disability scale, diminished pain intensity, and less analgesic consumption', 'side effects', 'visual analog scale, Oswestry Disability Index, and analgesic consumption', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0006668', 'cui_str': 'Calcitonin'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}]","[{'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",56.0,0.0704108,"A statistically significant decrease in visual analog scale, Oswestry Disability Index, and analgesic consumption was recorded in Group B as compared to Group A at 1, 2, and 3 months interval.","[{'ForeName': 'El-Sayed M', 'Initials': 'EM', 'LastName': 'El-Emam', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Enas A Abd', 'Initials': 'EAA', 'LastName': 'El Motlb', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_98_19']
2547,32843805,Ultrasound-Guided Adductor Canal Block versus Combined Adductor Canal and Infiltration between the Popliteal Artery and the Posterior Capsule of the Knee Block for Osteoarthritis Knee Pain.,"Context


Minimally invasive therapeutic modalities have been used to relieve refractory pain of knee osteoarthritis (OA).
Objective


The main objective of the study was to compare the adductor canal block (ACB) with combined ACB and infiltration between the popliteal artery and the posterior capsule of the knee (I-PACK) in patients suffering knee OA pain.
Patients and Methods


Fifty-six patients were randomly allocated into two equal groups: Group I received ultrasound-guided ACB with 10 mL of 0.125 bupivacaine plus 40 mg methylprednisolone And Group II received ultrasound-guided ACB with 10 mL of 0.125 bupivacaine plus 40 mg methylprednisolone and I-PACK block using same volume and concentration as ACB.
Results


Group II showed a statistically significant lower value of visual analog and Western Ontario and McMaster Universities scores at all follow-up intervals compared to Group I.
Conclusion


Combined ACB and I-PACK block provide more effective analgesia and better functional outcome compared to the ACB alone.",2020,"Results


Group II showed a statistically significant lower value of visual analog and Western Ontario and McMaster Universities scores at all follow-up intervals compared to Group I.
Conclusion


Combined ACB and I-PACK block provide more effective analgesia and better functional outcome compared to the ACB alone.","['Patients and Methods\n\n\nFifty-six patients', 'Osteoarthritis Knee Pain', 'patients suffering knee OA pain']","['Ultrasound-Guided Adductor Canal Block versus Combined Adductor Canal and Infiltration between the Popliteal Artery and the Posterior Capsule of the Knee Block', 'ultrasound-guided ACB with 10 mL of 0.125 bupivacaine plus 40 mg methylprednisolone And Group II received ultrasound-guided ACB with 10 mL of 0.125 bupivacaine plus 40 mg methylprednisolone and I-PACK block', 'adductor canal block (ACB) with combined ACB and infiltration between the popliteal artery and the posterior capsule of the knee (I-PACK']","['effective analgesia and better functional outcome', 'visual analog and Western Ontario and McMaster Universities scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",56.0,0.0495724,"Results


Group II showed a statistically significant lower value of visual analog and Western Ontario and McMaster Universities scores at all follow-up intervals compared to Group I.
Conclusion


Combined ACB and I-PACK block provide more effective analgesia and better functional outcome compared to the ACB alone.","[{'ForeName': 'El-Sayed M', 'Initials': 'EM', 'LastName': 'El-Emam', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Enas A Abd', 'Initials': 'EAA', 'LastName': 'El Motlb', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_109_19']
2548,32843807,Effect of Adding Hydrocortisone to Intraperitoneal Bupivacaine in Laparoscopic Bariatric Surgery.,"Background


Bariatric surgery is the effective management of obesity; however, postoperative pain is associated with a great morbidity. The management of pain is important for the enhancement of patient recovery. Local anesthetics can be injected during laparoscopic surgery into the peritoneum throughout the ports produced either before the beginning of laparoscopy or before the closure of the wound to reduce postoperative pain. Our aim is to evaluate if there is an additive analgesic effect by the administration of intraperitoneal hydrocortisone with streamed intraperitoneal bupivacaine as a method of postoperative pain relief in laparoscopic bariatric surgeries.
Patients and Methods


One hundred patients listed for laparoscopic bariatric surgery were the subject of this study. Patients were randomly allocated into two groups: Group I received 100 mg of 0.5% isobaric bupivacaine plus 20 mL normal saline intraperitoneally and Group II received intraperitoneal 100 mg of 0.5% isobaric bupivacaine + 100 mg hydrocortisone + 20 mL of saline at the end of the laparoscopic procedure. The primary outcome was the Visual Analog Scale (VAS) score for pain. The secondary outcomes were the time of first analgesic request, total opioid requirement, heart rate, and mean blood pressure.
Results


VAS showed a significant decrease at 4, 6, and 12 h postoperative in Group II compared to Group I. There was a marked decrease in total meperidine requirement with prolonged time of the first analgesic request in Group II compared to Group I.
Conclusion


Intraperitoneal hydrocortisone with bupivacaine had improved postoperative pain relief with a decrease in analgesic requirement.",2020,"There was a marked decrease in total meperidine requirement with prolonged time of the first analgesic request in Group II compared to Group I.
Conclusion


Intraperitoneal hydrocortisone with bupivacaine had improved postoperative pain relief with a decrease in analgesic requirement.","['Patients and Methods\n\n\nOne hundred patients listed for laparoscopic bariatric surgery', 'Laparoscopic Bariatric Surgery']","['bupivacaine', '100 mg of 0.5% isobaric bupivacaine plus 20 mL normal saline intraperitoneally and Group II received intraperitoneal 100 mg of 0.5% isobaric bupivacaine + 100 mg hydrocortisone + 20 mL of saline', '\n\n\nBariatric surgery', 'Local anesthetics', 'intraperitoneal hydrocortisone', 'Intraperitoneal Bupivacaine', 'Hydrocortisone']","['postoperative pain relief', 'total meperidine requirement', 'Visual Analog Scale (VAS) score for pain', 'analgesic requirement', 'time of first analgesic request, total opioid requirement, heart rate, and mean blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",100.0,0.107437,"There was a marked decrease in total meperidine requirement with prolonged time of the first analgesic request in Group II compared to Group I.
Conclusion


Intraperitoneal hydrocortisone with bupivacaine had improved postoperative pain relief with a decrease in analgesic requirement.","[{'ForeName': 'Ghada F', 'Initials': 'GF', 'LastName': 'Amer', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Hamed', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'M Said', 'Initials': 'MS', 'LastName': 'Salim', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Hegazy', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]","Anesthesia, essays and researches",['10.4103/aer.AER_141_19']
2549,32843833,Efficacy Study of Folic Acid Supplementation on Homocysteine Levels in Adolescent Epileptics Taking Antiepileptic Drugs: A Single Blind Randomized Controlled Clinical Trial.,"BACKGROUND


Epilepsy is a chronic medical condition that requires long-term therapy with antiepileptic drugs (AEDs). However, long-term employment of AEDs may lead to the onset of hyperhomocysteinemia, which has been found to modulate imperative metabolic mechanisms and induce cardiovascular disorders (CVDs). Therefore, adolescent population that have been diagnosed with epilepsy and utilize AEDs are among the most vulnerable, exhibiting higher risks of developing CVDs.
PURPOSE


The present study was designed to explore the effects of folic acid (FA) supplementation on AED-induced hyperhomocysteinemia and CVD risk factors in adolescent epileptics.
METHODS


The randomized clinical trial included adolescent epileptics (i.e., 10-19 years of age) of either sex, on antiepileptic therapy for > 6 months with high homocysteine levels (i.e., >10.9 µmol/L). At the time of enrolment, their baseline BP, lipid and homocysteine levels were recorded. Participants were randomly assigned to either treatment or placebo groups and received the respective treatments. At the end of the first month, BP, lipid and homocysteine levels were recorded and compared to determine the effect of FA on these parameters.
RESULTS AND CONCLUSION


A significant fall in homocysteine levels was observed with FA supplementation ( P  < 0.05). However, this fall was significantly high in valproic acid treated epileptic patients. In addition, we observed an improvement in high-density lipoprotein levels, a risk factor for CVDs, but the change was statistically insignificant ( P  > 0.05). The study results suggest that FA supplementation in epileptic patients receiving AED therapy may minimize AED-induced hyperhomocysteinemia and other CVD risk factors.",2019,A significant fall in homocysteine levels was observed with FA supplementation ( P  < 0.05).,"['adolescent epileptics (i.e., 10-19 years of age) of either sex, on antiepileptic therapy for > 6 months with high homocysteine levels (i.e., >10.9 µmol/L', 'Adolescent Epileptics', 'adolescent epileptics', 'epileptic patients receiving']","['Folic Acid Supplementation', 'FA supplementation', 'folic acid (FA) supplementation', 'Antiepileptic Drugs', 'placebo', 'AED therapy']","['baseline BP, lipid and homocysteine levels', 'AED-induced hyperhomocysteinemia and CVD risk factors', 'BP, lipid and homocysteine levels', 'Homocysteine Levels', 'homocysteine levels', 'high-density lipoprotein levels, a risk factor for CVDs']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0598608', 'cui_str': 'Hyperhomocysteinemia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.106474,A significant fall in homocysteine levels was observed with FA supplementation ( P  < 0.05).,"[{'ForeName': 'Uma A', 'Initials': 'UA', 'LastName': 'Bhosale', 'Affiliation': 'Deptartment of Pharmacology, SKNMC, Narhe (Ambegaon), Pune, Maharashtra, India.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Yegnanarayan', 'Affiliation': 'Deptartment of Pharmacology, SKNMC, Narhe (Ambegaon), Pune, Maharashtra, India.'}, {'ForeName': 'Akhil', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Deptartment of Pharmacology, SKNMC, Narhe (Ambegaon), Pune, Maharashtra, India.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Deptartment of Pharmacology, SKNMC, Narhe (Ambegaon), Pune, Maharashtra, India.'}]",Annals of neurosciences,['10.1177/0972753120925560']
2550,32843874,Barriers and facilitators to use of a clinical evidence technology in the management of skin problems in primary care: insights from mixed methods.,"Objective


Few studies have examined the impact of a single clinical evidence technology (CET) on provider practice or patient outcomes from the provider's perspective. A previous cluster-randomized controlled trial with patient-reported data tested the effectiveness of a CET (i.e., VisualDx) in improving skin problem outcomes but found no significant effect. The objectives of this follow-up study were to identify barriers and facilitators to the use of the CET from the perspective of primary care providers (PCPs) and to identify reasons why the CET did not affect outcomes in the trial.
Methods


Using a convergent mixed methods design, the authors had PCPs complete a post-trial survey and participate in interviews about using the CET for managing patients' skin problems. Data from both methods were integrated.
Results


PCPs found the CET somewhat easy to use but only occasionally useful. Less experienced PCPs used the CET more frequently. Data from interviews revealed barriers and facilitators at four steps of evidence-based practice: clinical question recognition, information acquisition, appraisal of relevance, and application with patients. Facilitators included uncertainty in dermatology, intention for use, convenience of access, diagnosis and treatment support, and patient communication. Barriers included confidence in dermatology, preference for other sources, interface difficulties, presence of irrelevant information, and lack of decision impact.
Conclusion


PCPs found the CET useful for diagnosis, treatment support, and patient communication. However, the barriers of interface difficulties, irrelevant search results, and preferred use of other sources limited its positive impact on patient skin problem management.",2020,"Data from interviews revealed barriers and facilitators at four steps of evidence-based practice: clinical question recognition, information acquisition, appraisal of relevance, and application with patients.",['skin problems in primary care'],['CET'],"['confidence in dermatology, preference for other sources, interface difficulties, presence of irrelevant information, and lack of decision impact', 'uncertainty in dermatology, intention for use, convenience of access, diagnosis and treatment support, and patient communication']","[{'cui': 'C0281822', 'cui_str': 'Skin problem'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0651627,"Data from interviews revealed barriers and facilitators at four steps of evidence-based practice: clinical question recognition, information acquisition, appraisal of relevance, and application with patients.","[{'ForeName': 'Marianne D', 'Initials': 'MD', 'LastName': 'Burke', 'Affiliation': 'Marianne.Burke@uvm.edu, Associate Professor of Libraries, Emerita, Dana Medical Library, University of Vermont, Burlington, VT.'}, {'ForeName': 'Liliane B', 'Initials': 'LB', 'LastName': 'Savard', 'Affiliation': 'Liliane.Savard@uvm.edu, Associate Faculty, Rehabilitation and Movement Science, Clinical and Translational Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rubin', 'Affiliation': 'Alan.Rubin@med.uvm.edu, Associate Professor, Department of Medicine, University of Vermont, Burlington, VT.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Littenberg', 'Affiliation': 'Benjamin.Littenberg@med.uvm.edu, Professor of Medicine, General Internal Medicine Research, Larner College of Medicine, University of Vermont, University of Vermont Medical Center, Burlington, VT.'}]",Journal of the Medical Library Association : JMLA,['10.5195/jmla.2020.787']
2551,32843994,Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting.,"Background


Clinical trials remain the cornerstone of improving outcomes for HIV-infected individuals with cryptococcal meningitis. Community engagement aims at involving participants and their advocates as partners in research rather than merely trial subjects. Community engagement can help to build trust in communities where these trials are conducted and ensure lasting mutually beneficial relationships between researchers and the community. Similarly, different studies have reported the positive effects of social support on patient's outcomes. We aimed to describe our approach to community engagement in Uganda while highlighting the benefits of community engagement and social support in clinical trials managing patients co-infected with HIV and cryptococcal meningitis.
Methods


We carried out community engagement using home visits, health talks, posters, music and drama. In addition, social support was given through study staff individually contributing to provide funds for participants' food, wheel chairs, imaging studies, adult diapers, and other extra investigations or drugs that were not covered by the study budget or protocol. The benefits of this community engagement and social support were assessed during two multi-site, randomized cryptococcal meningitis clinical trials in Uganda.
Results


We screened 1739 HIV-infected adults and enrolled 934 with cryptococcal meningitis into the COAT and ASTRO-CM trials during the period October 2010 to July 2017. Lumbar puncture refusal rates decreased from 31% in 2010 to less than 1% in 2017. In our opinion, community engagement and social support played an important role in improving: drug adherence, acceptance of lumbar punctures, data completeness, rate of screening/referrals, reduction of missed visits, and loss to follow-up.
Conclusions


Community engagement and social support are important aspects of clinical research and should be incorporated into clinical trial design and conduct.
Trial registration


ClinicalTrials.gov number, NCT01075152 and NCT01802385.",2020,"In our opinion, community engagement and social support played an important role in improving: drug adherence, acceptance of lumbar punctures, data completeness, rate of screening/referrals, reduction of missed visits, and loss to follow-up.
","['HIV-infected individuals with cryptococcal meningitis', '1739 HIV-infected adults and enrolled 934 with cryptococcal meningitis into the COAT and ASTRO-CM trials during the period October 2010 to July 2017', 'participants and their advocates as partners in research rather than merely trial subjects', 'patients co-infected with HIV and cryptococcal meningitis']",['community engagement and social support'],['Lumbar puncture refusal rates'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]","[{'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}]",934.0,0.146773,"In our opinion, community engagement and social support played an important role in improving: drug adherence, acceptance of lumbar punctures, data completeness, rate of screening/referrals, reduction of missed visits, and loss to follow-up.
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kwizera', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O.BOX 22418 Kampala, Uganda.'}, {'ForeName': 'Alisat', 'Initials': 'A', 'LastName': 'Sadiq', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O.BOX 22418 Kampala, Uganda.'}, {'ForeName': 'Jane Frances', 'Initials': 'JF', 'LastName': 'Ndyetukira', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O.BOX 22418 Kampala, Uganda.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nalintya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O.BOX 22418 Kampala, Uganda.'}, {'ForeName': 'Darlisha', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O.BOX 22418 Kampala, Uganda.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rhein', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O.BOX 22418 Kampala, Uganda.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Division of Infectious Diseases and International Medicine, Department of Medicine, University of Minnesota, Minneapolis, MN USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, P.O.BOX 22418 Kampala, Uganda.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Research involvement and engagement,['10.1186/s40900-020-00228-z']
2552,32844140,Mindfulness Education for Otolaryngology Residents: A Pilot Study.,"This pilot project was designed to (1) implement a mindfulness-based wellness curriculum for otolaryngology residents, (2) determine the impact of a mindfulness-based curriculum on resident mood, and (3) examine the use of mindfulness among otolaryngology residents. Otolaryngology residents participated in a 6-week course guided by the Headspace mindfulness mobile application. Resident use of mindfulness was measured by the validated Mindful Attention Awareness Scale (MAAS). Changes in mood before and after each session were assessed using the validated Positive and Negative Affect Schedule (PNAS). Residents reported a statistically significant decrease in postsession negative affect scores ( P  < .001). A moderate positive correlation was noted between mindfulness scores and presession positive mood (Pearson  r  = 0.597,  P  < .001). This pilot study supports the feasibility and impact of including mindfulness training as part of a resident wellness curriculum.",2020,Residents reported a statistically significant decrease in postsession negative affect scores ( P  < .001).,"['Otolaryngology Residents', 'Otolaryngology residents participated in a 6-week course guided by the Headspace mindfulness mobile application']","['mindfulness training', 'mindfulness-based curriculum on resident mood, and (3) examine the use of mindfulness among otolaryngology residents']","['mindfulness scores and presession positive mood (Pearson', 'postsession negative affect scores', 'validated Mindful Attention Awareness Scale (MAAS']","[{'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0135174,Residents reported a statistically significant decrease in postsession negative affect scores ( P  < .001).,"[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kashat', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Bridgette', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': ""Connecticut Children's, Hartford, Connecticut, USA.""}, {'ForeName': 'Maua', 'Initials': 'M', 'LastName': 'Mosha', 'Affiliation': ""Connecticut Children's, Hartford, Connecticut, USA.""}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Kavanagh', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, Connecticut, USA.'}]",OTO open,['10.1177/2473974X20945277']
2553,32847838,Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial.,"OBJECTIVE


In the phase 3 CELESTIAL trial, cabozantinib improved overall survival (OS) and progression-free survival (PFS) compared with placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). This subgroup analysis evaluated cabozantinib in patients who had received sorafenib as the only prior systemic therapy.
METHODS


CELESTIAL randomised (2:1) patients with advanced HCC and Child-Pugh class A liver function to treatment with cabozantinib (60 mg daily) or placebo. Eligibility required prior treatment with sorafenib, and patients could have received ≤2 prior systemic regimens. The primary endpoint was OS. Outcomes in patients who had received sorafenib as the only prior therapy were analysed by duration of prior sorafenib (<3 months, 3 to <6 months and ≥6 months).
RESULTS


Of patients who had received only prior sorafenib, 331 were randomised to cabozantinib and 164 to placebo; 136 patients had received sorafenib for <3 months, 141 for 3 to <6 months and 217 for ≥6 months. Cabozantinib improved OS relative to placebo in the overall second-line population who had received only prior sorafenib (median 11.3 vs 7.2 months; HR=0.70, 95% CI 0.55 to 0.88). This improvement was maintained in analyses by prior sorafenib duration with longer duration generally corresponding to longer median OS-median OS 8.9 vs 6.9 months (HR=0.72, 95% CI 0.47 to 1.10) for prior sorafenib <3 months, 11.5 vs 6.5 months (HR=0.65, 95% CI 0.43 to 1.00) for 3 to <6 months and 12.3 vs 9.2 months (HR=0.82, 95% CI 0.58 to 1.16) for ≥6 months. Cabozantinib also improved PFS in all duration subgroups. Safety data were consistent with the overall study population.
CONCLUSION


Cabozantinib improved efficacy outcomes versus placebo in the second-line population who had received only prior sorafenib irrespective of duration of prior sorafenib treatment, further supporting the utility of cabozantinib in the evolving treatment landscape of HCC.
CLINICAL TRIAL NUMBER


NCT01908426.",2020,"This improvement was maintained in analyses by prior sorafenib duration with longer duration generally corresponding to longer median OS-median OS 8.9 vs 6.9 months (HR=0.72, 95% CI 0.47 to 1.10) for prior sorafenib <3 months, 11.5 vs 6.5 months (HR=0.65, 95% CI 0.43 to 1.00) for 3 to <6 months and 12.3 vs 9.2 months (HR=0.82, 95% CI 0.58 to 1.16) for ≥6 months.","['CELESTIAL randomised (2:1) patients with advanced HCC and Child', 'patients who had received sorafenib as the only prior systemic therapy', '136 patients had received', 'patients with previously treated advanced hepatocellular carcinoma (HCC', 'advanced hepatocellular carcinoma']","['Pugh class', 'placebo', 'cabozantinib', 'sorafenib']","['overall survival (OS) and progression-free survival (PFS', 'efficacy outcomes', 'OS relative', 'OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.171016,"This improvement was maintained in analyses by prior sorafenib duration with longer duration generally corresponding to longer median OS-median OS 8.9 vs 6.9 months (HR=0.72, 95% CI 0.47 to 1.10) for prior sorafenib <3 months, 11.5 vs 6.5 months (HR=0.65, 95% CI 0.43 to 1.00) for 3 to <6 months and 12.3 vs 9.2 months (HR=0.82, 95% CI 0.58 to 1.16) for ≥6 months.","[{'ForeName': 'Robin Kate', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA katie.kelley@ucsf.edu.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Groupement Hospitalier Lyon Nord, Lyon, France.'}, {'ForeName': 'Joong-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bolondi', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, State Key Laboratory in Oncology in South China, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'Ari D', 'Initials': 'AD', 'LastName': 'Baron', 'Affiliation': 'California Pacific Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': 'Adelaide Cancer Centre, Adelaide University, Kurralta Park, South Australia, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Knox', 'Affiliation': 'Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cattan', 'Affiliation': 'CHRU Lille, Lille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': 'Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lougheed', 'Affiliation': 'Medical Affairs, Exelixis Inc, Alameda, California, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Milwee', 'Affiliation': 'Clinical Development, Exelixis Inc, Alameda, California, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, California, USA.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital, London, UK.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, United States.'}]",ESMO open,['10.1136/esmoopen-2020-000714']
2554,32847900,Effects of preconditioning by nasal splint and mouth breathing on emergence delirium after functional endoscopic sinus surgery in Chinese adults: a study protocol for a randomised controlled trial.,"INTRODUCTION


Emergence delirium (ED) is a common adverse manifestation after general anaesthesia and may result in undesirable consequences. Its causes and mechanisms are diverse and complex, and it is still unavoidable in clinical work. There is a high incidence of ED after otorhinolaryngology surgery, which may result from the sudden loss of functional senses and discomfort of surgical organs. This study aims to test a non-invasive, non-drug treatment modality of nose clamping and mouth-breathing training before surgery to reduce ED.
METHODS AND ANALYSIS


This prospective randomised controlled trial (RCT) will include 200 patients who undergo functional endoscopic sinus surgery (FESS) at Shanghai General Hospital, China. Study participants will be randomly assigned in two groups with a 1:1 ratio. The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme. After surgery, we will perform a single-blinded assessment of ED occurrence with stratification. IBM SPSS Statistics V.20 statistical software will be used for statistical analyses. A X 2  test will be used to compare the two groups, and t-tests will determine the statistical significance of continuous variables.
ETHICS AND DISSEMINATION


This RCT was designed in accordance with the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Shanghai General Hospital, ID: 2019KY039.We expect to release the original data in February 2022 on the ResMan original data sharing platform (IPD sharing platform) of the China clinical trial registry, which can be viewed at the following website:http://www.medresman.org.cn/pub/cn/proj/projectshow.aspx?proj=6293.
TRIAL REGISTRATION NUMBER


ChiCTR1900024925.",2020,"The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme.","['Chinese adults', '200 patients who undergo functional endoscopic sinus surgery (FESS) at Shanghai General Hospital, China']","['functional endoscopic sinus surgery', 'preconditioning by nasal splint and mouth breathing', 'nose clamping and mouth-breathing training', 'intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention']",['IBM SPSS Statistics'],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0490829', 'cui_str': 'Nasal splint'}, {'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",200.0,0.17841,"The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme.","[{'ForeName': 'Hongjiao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Anaesthesiology, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Zhenyuan', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Medical department, Mellon community health service center, Shanghai, China.'}, {'ForeName': 'Weiwen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Yachun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Yuyu', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Pei', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China lijinbaoshanghai@163.com.""}]",BMJ open,['10.1136/bmjopen-2019-033803']
2555,32847902,Smartphone-delivered self-management for first-episode psychosis: the ARIES feasibility randomised controlled trial.,"OBJECTIVES


To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.
DESIGN


A two-arm unblinded feasibility RCT.
SETTING


Six NHS EIP services in England.
PARTICIPANTS


Adults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).
INTERVENTIONS


Participants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users' discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.
PRIMARY AND SECONDARY OUTCOME MEASURES


Feasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.
RESULTS


83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.
CONCLUSIONS


Recruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.
TRIAL REGISTRATION


ISRCTN10004994.",2020,"To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.
","['Early Intervention in Psychosis (EIP) services', 'Participants were recruited until the recruitment target was met (n=40', 'Adults using EIP services who own an Android Smartphone', 'first-episode psychosis', 'Six NHS EIP services in England']","['usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone', 'Smartphone-based self-management tool', 'Smartphone-delivered self-management']","['median number of My Journey', 'recruitment, follow-up rates and intervention engagement', 'serious adverse events', 'median total minutes spent']","[{'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.220355,"To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steare', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Puffin', 'Initials': 'P', 'LastName': ""O'Hanlon"", 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eskinazi', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rostill', 'Affiliation': 'University of Surrey, Guildford, Surrey, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Amani', 'Affiliation': 'Early Intervention in Psychosis Programme (South of England), Oxford, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK s.johnson@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034927']
2556,32847912,"Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study.","INTRODUCTION


The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.
METHODS AND ANALYSIS


The REStricted Eating Time (RESET) study is a randomised controlled parallel-group open-label trial. 100 women and men with (1) overweight (body mass index (BMI)≥25 kg/m 2 ) and prediabetes (glycated haemoglobin 39-47 mmol/mol); or (2) obesity (BMI≥30 kg/m 2 ) will be randomised to a control group (habitual living) or TRE (self-selected 10-hours eating window within the period from 06:00 to 20:00 in a 1:1 ratio. Testing is scheduled at baseline and after 6 weeks (mid-intervention), 3 months (post-intervention) and 6 months (follow-up). The primary outcome is change in body weight after 3 months of intervention. Secondary outcomes include changes in body composition; measures of glucose metabolism including glycaemic variability, hormones and metabolites; subjective and metabolic markers of appetite, food preferences and reward; dietary intake; physical activity, sleep, chronotype; gastric emptying, gastrointestinal transit time and motility; respiratory and glycolytic capacities; the plasma proteome and metabolome; blood pressure, resting heart rate and heart rate variability; and resting energy expenditure and substrate oxidation. Motivation and feasibility will be examined based on interviews at baseline and after 3 months. After the 3-month intervention, a 3-month follow-up period and subsequent testing are scheduled to assess maintenance and longer-term effects.
ETHICS AND DISSEMINATION


The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-18059188) and the Danish Data Protection Agency. The study will be conducted in accordance with the Declaration of Helsinki. Results from the study will address whether TRE is effective and feasible in improving health outcomes in individuals at risk of lifestyle-related diseases and can potentially inform the design of feasible health recommendations.
TRIAL REGISTRATION NUMBER


NCT03854656.",2020,"The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.
","['100 women and men with (1) overweight (body mass index (BMI)≥25\u2009kg/m 2 ) and prediabetes (glycated haemoglobin 39-47\u2009mmol/mol); or (2) obesity (BMI≥30\u2009kg/m 2 ', 'individuals at high risk of type 2 diabetes']","['control group (habitual living) or TRE (self-selected 10-hours eating window', 'time-restricted eating (TRE', 'TRE']","['change in body weight', 'health outcomes', 'changes in body composition; measures of glucose metabolism including glycaemic variability, hormones and metabolites; subjective and metabolic markers of appetite, food preferences and reward; dietary intake; physical activity, sleep, chronotype; gastric emptying, gastrointestinal transit time and motility; respiratory and glycolytic capacities; the plasma proteome and metabolome; blood pressure, resting heart rate and heart rate variability; and resting energy expenditure and substrate oxidation', 'body weight, behaviour and metabolism']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0232484', 'cui_str': 'Gastrointestinal transit time'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0751973', 'cui_str': 'Proteomes'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",100.0,0.0958709,"The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.
","[{'ForeName': 'Jonas S', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark jonas.salling.quist@regionh.dk.'}, {'ForeName': 'Marie M', 'Initials': 'MM', 'LastName': 'Jensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kim K B', 'Initials': 'KKB', 'LastName': 'Clemmensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Natasja', 'Initials': 'N', 'LastName': 'Bjerre', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Størling', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe S', 'Initials': 'SS', 'LastName': 'Torekov', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-037166']
2557,32847924,'There were some clues': a qualitative study of heuristics used by parents of adolescents to make credibility judgements of online health news articles citing research.,"OBJECTIVE


To identify how parents judge the credibility of online health news stories with links to scientific research.
DESIGN


This qualitative study interviewed parents who read online stories about e-cigarettes and human papillomavirus (HPV) vaccination published by top-tier US news organisations. Researchers asked participants to describe elements of a story that influenced their judgement about content credibility. Researchers analysed transcripts using inductive and deductive techniques. Deductive analysis drew on cognitive heuristics previously identified as being used by the public to judge online health information. Inductive analysis allowed the emergence of new heuristics, especially relating to health.
SETTING


The US National Cancer Institute's Audience Research Lab in Maryland, in August-November 2018.
PARTICIPANTS


Sixty-four parents with at least one child between the ages of 9 and 17 residing in Maryland, Virginia, or the District of Columbia participated. Researchers randomly assigned 31 parents to the HPV vaccination story and 33 to the e-cigarette story.
RESULTS


Evidence of existing heuristics, including reputation, endorsement, consistency, self-confirmation, expectancy violation and persuasive intent emerged from the interviews, with participants deeming stories credible when mentioning physicians (reputation heuristic) and/or consistent with information provided by personal physicians (consistency heuristic). Participants also described making credibility judgements based on presence of statistics, links to scientific research and their general feelings about news media. In relation to presence of statistics and links, participants reported these elements increased the credibility of the news story, whereas their feelings about the news media decreased their credibility judgement.
CONCLUSIONS


Parents used a constellation of heuristics to judge the credibility of online health news stories. Previously identified heuristics for online health information are also applicable in the context of health news stories. The findings have implications for initiatives in education, health communication and journalism directed towards increasing the public's engagement with health news and their credibility judgements.",2020,"The findings have implications for initiatives in education, health communication and journalism directed towards increasing the public's engagement with health news and their credibility judgements.","[""The US National Cancer Institute's Audience Research Lab in Maryland, in August-November 2018"", 'Sixty-four parents with at least one child between the ages of 9 and 17 residing in Maryland, Virginia, or the District of Columbia participated', 'parents who read online stories about e-cigarettes and human papillomavirus (HPV) vaccination published by top-tier US news organisations']",['HPV vaccination story and 33 to the e-cigarette story'],[],"[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0004281', 'cui_str': 'Audience Research'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0012764', 'cui_str': 'District of Columbia'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]",[],64.0,0.030133,"The findings have implications for initiatives in education, health communication and journalism directed towards increasing the public's engagement with health news and their credibility judgements.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Maggio', 'Affiliation': 'Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA lauren.maggio@usuhs.edu.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Krakow', 'Affiliation': 'Population Health, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Moorhead', 'Affiliation': 'Journalism, San Francisco State University, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039692']
2558,32847927,Study protocol for a pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of standard and new antiepileptic drugs (SANAD-II).,"INTRODUCTION


Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Over the past 20 years, a number of new drugs have been approved for National Health Service (NHS) use on the basis of information from short-term trials that demonstrate efficacy. These trials do not provide information about the longer term outcomes, which inform treatment policy. This trial will assess the long-term clinical and cost-effectiveness of the newer treatment levetiracetam and zonisamide.
METHODS AND ANALYSIS


This is a phase IV, multicentre, open-label, randomised, controlled clinical trial comparing new and standard treatments for patients with newly diagnosed epilepsy. Arm A of the trial randomised 990 patients with focal epilepsy to standard AED lamotrigine or new AED levetiracetam or zonisamide. Arm B randomised 520 patients with generalised epilepsy to standard AED sodium valproate or new AED levetiracetam. Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics. Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs. Patients are followed up for a minimum of 2 years. The primary outcome is time to 12-month remission from seizures. Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life. All primary analyses will be on an intention to treat basis. Separate analyses will be undertaken for each arm. Health economic analysis will be conducted from the perspective of the NHS to assess the cost-effectiveness of each AED.
ETHICS AND DISSEMINATION


This trial has been approved by the North West-Liverpool East REC (Ref. 12/NW/0361). The trial team will disseminate the results through scientific meetings, peer-reviewed publications and patient and public involvement.
TRIAL REGISTRATION NUMBERS


EudraCT 2012-001884-64; ISRCTN30294119.",2020,Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life.,"['520 patients with generalised epilepsy to', 'epilepsy', 'Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs', '990 patients with focal epilepsy to', 'Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics', 'patients with newly diagnosed epilepsy']","['standard AED sodium valproate or new AED levetiracetam', 'standard AED lamotrigine or new AED levetiracetam or zonisamide', 'levetiracetam and zonisamide', 'zonisamide']","['time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life', 'effectiveness and cost-effectiveness', 'time to 12-month remission from seizures']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",990.0,0.298206,Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life.,"[{'ForeName': 'Silviya', 'Initials': 'S', 'LastName': 'Balabanova', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Sills', 'Affiliation': 'School of Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Biostatistics, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Phil E M', 'Initials': 'PEM', 'LastName': 'Smith', 'Affiliation': 'Department of Neurology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': ""Paediatric Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Leach', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Department of Brain Sciences, Imperial College London Faculty of Medicine-South Kensington Campus, London, UK.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Pharmacology, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur-Smith', 'Affiliation': 'Biostatistics, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Anthony Guy', 'Initials': 'AG', 'LastName': 'Marson', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK marjon01@liverpool.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-040635']
2559,32847946,Is there an association between subjective sleep quality and daily delirium occurrence in critically ill adults? A post hoc analysis of a randomised controlled trial.,"OBJECTIVES


Whether and how delirium and sleep quality in the intensive care unit (ICU) are linked remains unclear. A recent randomised trial reported nocturnal low-dose dexmedetomidine (DEX) significantly reduces incident ICU delirium. Leeds Sleep Evaluation Questionnaire (LSEQ) scores were similar between intervention (DEX; n=50) and control (placebo (PLA); n=50) groups. We measured the association between morning LSEQ and delirium occurrence in the prior 24 hours (retrospective analysis) and the association between morning LSEQ and delirium occurrence in the following 24 hours (predictive analysis).
DESIGN


Post hoc analysis of randomised controlled trial data.
PARTICIPANTS


Adult ICU patients (n=100) underwent delirium screening twice a day using the Intensive Care Delirium Screening Checklist (ICDSC) if Richmond Agitation Sedation Scale (RASS) was ≥-3 and patient-reported sleep quality evaluations at 09:00 daily with the LSEQ if RASS was ≥-1.
OUTCOMES


The analysis included all 24-hour study periods with LSEQ documentation and matched delirium screening in coma-free patients. Separate logistic regression models controlling for age, baseline Acute Physiology and Chronic Health Evaluation II score and DEX/PLA allocation evaluated the association between morning LSEQ and delirium occurrence for both retrospective and predictive analyses.
RESULTS


The 100 patients spent 1115 24-hour periods in the ICU. Coma, delirium and no delirium occurred in 130 (11.7%), 114 (10.2%) and 871 (78.1%), respectively. In the retrospective analysis, when an LSEQ result was preceded by an ICDSC result (439/985 (44.6%) 24-hour periods), delirium occurred during 41/439 (9.3%) periods. On regression analysis, the LSEQ score had no relationship to prior delirium occurrence (OR (per every 1 point average LSEQ change) 0.97, 95% CI 0.72 to 1.31). For the predictive analysis, among the 387/985 (39.1%) 24-hour periods where an LSEQ result was followed by an ICDSC result, delirium occurred during 56/387 (14.5%) periods. On regression analysis, the LSEQ score did not predict subsequent delirium occurrence (OR (per 1 point LSEQ change) 1.02, 95% CI 0.99 to 1.05).
CONCLUSIONS


The sleep quality ICU patients perceive neither affects nor predicts delirium occurrence.
TRIAL REGISTRATION NUMBER


NCT01791296.",2020,scores were similar between intervention (DEX; n=50) and control (placebo (PLA); n=50) groups.,"['coma-free patients', 'Adult ICU patients (n=100) underwent', 'critically ill adults', '100 patients spent 1115 24-hour periods in the ICU']","['control (placebo', 'dexmedetomidine (DEX', 'delirium screening twice a day using the Intensive Care Delirium Screening Checklist (ICDSC) if Richmond Agitation Sedation Scale (RASS']","['sleep quality evaluations', 'delirium', 'subjective sleep quality and daily delirium occurrence', 'Coma, delirium and no delirium', 'morning LSEQ and delirium occurrence', 'delirium occurrence (OR', 'incident ICU delirium', 'Leeds Sleep Evaluation Questionnaire (LSEQ']","[{'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4524095', 'cui_str': 'Intensive care unit delirium'}]",,0.322439,scores were similar between intervention (DEX; n=50) and control (placebo (PLA); n=50) groups.,"[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Duprey', 'Affiliation': 'Pharmacy and Health Systems Sciences, Northeastern University, Boston, Massachusetts, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Pharmacy and Health Systems Sciences, Northeastern University, Boston, Massachusetts, USA.'}, {'ForeName': 'Yoanna', 'Initials': 'Y', 'LastName': 'Skrobik', 'Affiliation': 'Medicine, McGill University Health Centre, Montreal, Quebec, Canada yoanna.skrobik@mcgill.ca.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000576']
2560,32847980,Circulating Tumor Cells In Advanced Cervical Cancer:   NRG Oncology - Gynecologic Oncology Group Study 240 (NCT 00803062) .,"PURPOSE


To isolate circulating tumor cells (CTCs) from women with advanced cervical cancer and estimate the impact of CTCs and treatment on overall survival (OS) and progression-free survival (PFS).
EXPERIMENTAL DESIGN


7.5 mL of whole blood was drawn pre-cycle 1 and 36 days post-cycle 1 from patients enrolled on Gynecologic Oncology Group 0240, the phase III randomized trial that led directly to regulatory approval of the anti-angiogenesis drug, bevacizumab, in women with recurrent/metastatic cervical cancer. CTCs (defined as anti-cytokeratin positive/anti-CD45 negative cells) were isolated from the buffy coat layer using an anti-EpCAM antibody-conjugated ferrofluid and rare earth magnet, and counted using a semi-automated fluorescence microscope.
RESULTS


The median pre-cycle 1 CTC count was 7 CTCs/7.5 mL whole blood (range, 0-18) and, at 36 days post-treatment, was 4 (range, 0-17). The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95). Among patients with high (> median) pre-treatment CTCs, bevacizumab treatment was associated with a reduction in the hazard of death (HR 0.57; 95% CI, 0.32-1.03) and progression (PFS HR 0.59; 95% CI, 0.36-0.96). This effect was not observed with low (< median) CTCs.
CONCLUSIONS


CTCs can be isolated from women with advanced cervical cancer and may have prognostic significance. A survival benefit conferred by bevacizumab among patients with high pre-treatment CTCs may reflect increased tumor neovascularization and concomitant vulnerability to VEGF inhibition. These data support studying CTC capture as a potential predictive biomarker.",2020,"The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95).","['Advanced Cervical Cancer', 'women with advanced cervical cancer', 'women with recurrent/metastatic cervical cancer']","['regulatory approval of the anti-angiogenesis drug, bevacizumab', 'bevacizumab']","['median pre-cycle 1 CTC count', 'overall survival (OS) and progression-free survival (PFS', 'risk of death', 'declination in CTCs', 'hazard of death']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278584', 'cui_str': 'Cervix cancer metastatic'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.128951,"The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95).","[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'OB/GYN, University of California Medical Center, Irvine ktewari@uci.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'CTDD, Roswell Park Comprehensive Cancer Center.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, St. Joseph's Hospital.""}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Hem Onc, Massachusetts General Hospital.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Moore', 'Affiliation': 'Gyn Onc, Franciscan St. Francis Health.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': 'Operations Center- Philadelphia East, NRG Oncology.'}, {'ForeName': 'Lois M', 'Initials': 'LM', 'LastName': 'Ramondetta', 'Affiliation': 'Department of Gynecologic Oncology, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Landrum', 'Affiliation': 'Departments of Pathology and Obstetrics and Gynecology, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'Gynecologic Oncology, Virginia Commonwealth University.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Medical Oncology Gynaecological Cancer Unit, Vall d'Hebron University Hospital Vall d'Hebron Institute of Oncology (VHIO).""}, {'ForeName': 'Mario M', 'Initials': 'MM', 'LastName': 'Leitao', 'Affiliation': 'Surgery, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Eisenhauer', 'Affiliation': 'OB/GYN, Massachusetts General Hospital.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': ""Program in Women's Oncology, Women and Infants Hospital,\xa0Providence, RI\xa002905.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Le', 'Affiliation': 'School of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Medicine, Stony Brook University Medical Center.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Burke', 'Affiliation': 'Gynecologic Oncology, Southeast Cancer Control Consortium.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': 'Ohio State University College of Medicine.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Richardson', 'Affiliation': 'Obstetrics and Gynecology, UT Southwestern Medical Center at Dallas.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Michael', 'Affiliation': 'Pathology, Indiana University School of Medicine.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kindelberger', 'Affiliation': 'Boston Medical Center BMC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'Medicine, University of Alabama at Birmingham.'}]",Molecular cancer therapeutics,['10.1158/1535-7163.MCT-20-0276']
2561,32848537,Heart Rate Variability in Head-Up Tilt Tests in Adolescent Postural Tachycardia Syndrome Patients.,"Introduction:  Postural tachycardia syndrome (POTS) is a suspected dysautonomia with symptoms of orthostatic intolerance and abnormally increased heart rate while standing. We aimed to study cardiac autonomic nervous system functioning in head-up tilt (HUT) in adolescents with POTS to find out if parasympathetic tone is attenuated in the upright position.  Methods:  We compared characteristics of a group of 25 (females 14/25; 56%) adolescents with POTS and 12 (females 4/12; 34%) without POTS aged 9-17 years. We compared heart rate variability with high- and low-frequency oscillations, and their temporal changes in HUT.  Results:  The high-frequency oscillations, i.e., HF, attenuated in both groups during HUT ( p  < 0.05), but the attenuation was bigger in POTS ( p  = 0.04). In the beginning of HUT, low-frequency oscillations, i.e., LF, increased more in POTS ( p  = 0.01), but in the end of HUT, an attenuation in LF was seen in the POTS group ( p  < 0.05), but not in the subjects without POTS. There were no associations of previous infections or vaccinations with POTS. Subjects with POTS were sleepier and their overall quality of life was very low.  Conclusion:  The results imply to an impaired autonomic regulation while standing in POTS, presenting as a lower HF and higher LF in the beginning of HUT and an attenuated LF in the prolonged standing position.",2020,"The high-frequency oscillations, i.e., HF, attenuated in both groups during HUT ( p  < 0.05), but the attenuation was bigger in POTS ( p  = 0.04).","['adolescents with POTS', 'Adolescent Postural Tachycardia Syndrome Patients', 'group of 25 (females 14/25; 56%) adolescents with POTS and 12 (females 4/12; 34%) without POTS aged 9-17 years']",['Introduction:  Postural tachycardia syndrome (POTS'],"['Heart Rate Variability', 'overall quality of life', 'heart rate variability', 'attenuation in LF']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0024809', 'cui_str': 'Marihuana Abuse'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0024809', 'cui_str': 'Marihuana Abuse'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0333901,"The high-frequency oscillations, i.e., HF, attenuated in both groups during HUT ( p  < 0.05), but the attenuation was bigger in POTS ( p  = 0.04).","[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Orjatsalo', 'Affiliation': 'Department of Clinical Neurophysiology, HUS Medical Imaging Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Alakuijala', 'Affiliation': 'Department of Clinical Neurophysiology, HUS Medical Imaging Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Partinen', 'Affiliation': 'Department of Neurological Sciences, University of Helsinki, Helsinki, Finland.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00725']
2562,32848547,Bedtime Stress Increases Sleep Latency and Impairs Next-Day Prospective Memory Performance.,"The cognitive construct of prospective memory (PM) refers to the capacity to encode, retain and execute delayed intentions (e.g. to remember to buy milk on the way home). Although previous research suggests that PM performance is enhanced by healthy sleep, conclusions tend to be drawn based on designs featuring ecologically unnatural manipulations (e.g. total sleep deprivation). This study investigates whether a more common everyday experience (bedtime stress) affects next-day PM performance and, in so doing, also contributes to the heretofore inconsistent literature on stress and PM. Forty young adults received PM task instructions and were then assigned to either a stress condition (exposure to a laboratory-based stress-induction manipulation;  n  = 20, 9 women) or a non-stress condition (exposure to a non-stressful control manipulation;  n  = 20, 12 women). After completing the experimental manipulation, all participants had their objective sleep quality measured over a full night of polysomnographic monitoring. Upon awakening, they completed the PM task. Analyses detected significant between-group differences in terms of stress outcomes, sleep quality and PM performance: Participants exposed to the manipulation experienced heightened signs of stress (captured using a composite variable that included self-report, psychophysiological and endocrinological measures), had longer sleep latencies and poorer sleep depth and displayed significantly longer reaction times to PM cues. An interaction between experimental condition (being exposed to the stressor) and disrupted sleep (longer sleep latency) significantly predicted poorer next-day PM reaction time. We interpret these findings as indicating that bedtime stress, which leads to heightened presleep arousal, affects sleep processes and, consequently, the deployment of attentional resources during next-day execution of a delayed intention.",2020,"Analyses detected significant between-group differences in terms of stress outcomes, sleep quality and PM performance: Participants exposed to the manipulation experienced heightened signs of stress (captured using a composite variable that included self-report, psychophysiological and endocrinological measures), had longer sleep latencies and poorer sleep depth and displayed significantly longer reaction times to PM cues.",['Forty young adults'],"['PM task instructions', 'stress condition (exposure to a laboratory-based stress-induction manipulation;  n  = 20, 9 women) or a non-stress condition (exposure to a non-stressful control manipulation']","['Bedtime Stress Increases Sleep Latency and Impairs Next-Day Prospective Memory Performance', 'longer sleep latencies and poorer sleep depth', 'objective sleep quality', 'stress outcomes, sleep quality and PM performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",40.0,0.0170135,"Analyses detected significant between-group differences in terms of stress outcomes, sleep quality and PM performance: Participants exposed to the manipulation experienced heightened signs of stress (captured using a composite variable that included self-report, psychophysiological and endocrinological measures), had longer sleep latencies and poorer sleep depth and displayed significantly longer reaction times to PM cues.","[{'ForeName': 'Zoë-Lee', 'Initials': 'ZL', 'LastName': 'Goldberg', 'Affiliation': 'ACSENT Laboratory, Department of Psychology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Kevin G F', 'Initials': 'KGF', 'LastName': 'Thomas', 'Affiliation': 'ACSENT Laboratory, Department of Psychology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gosia', 'Initials': 'G', 'LastName': 'Lipinska', 'Affiliation': 'ACSENT Laboratory, Department of Psychology, University of Cape Town, Cape Town, South Africa.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00756']
2563,32848571,Oxytocin Facilitation of Emotional Empathy Is Associated With Increased Eye Gaze Toward the Faces of Individuals in Emotional Contexts.,"One of the most robust effects of intranasal oxytocin treatment is its enhancement of emotional empathy responses across cultures to individuals displaying emotions in realistic contexts in the Multifaceted Empathy Task (MET). However, it is not established if this effect of oxytocin on emotional empathy is due to altered visual attention toward different components of the stimulus pictures or an enhanced empathic response. In the current randomized placebo-controlled within-subject experiment on 40 healthy male individuals, we both attempted a further replication of emotional empathy enhancement by intranasal oxytocin (24 IU) and used eye-tracking measures to determine if this was associated by altered visual attention toward different components of the picture stimuli (background context, human face, and body posture). Results replicated previous findings of enhanced emotional empathy in response to both negative and positive stimuli and that this was associated with an increased proportion of time viewing the faces of humans in the pictures and a corresponding decrease in that toward the rest of the body and/or background context. Overall, our findings suggest that enhanced emotional empathy following oxytocin administration is due to increased attention to the faces of others displaying emotions and away from other contextual and social cues.  Clinical Trial Registration:  www.ClinicalTrials.gov Oxytocin Modulates Eye Gaze Behavior During Social Processing; registration ID: NCT03293511; URL: https://clinicaltrials.gov/ct2/show/NCT03293511.",2020,"However, it is not established if this effect of oxytocin on emotional empathy is due to altered visual attention toward different components of the stimulus pictures or an enhanced empathic response.",['40 healthy male individuals'],"['ClinicalTrials.gov Oxytocin', 'intranasal oxytocin', 'oxytocin', 'placebo', 'Oxytocin']","['proportion of time viewing the faces of humans', 'emotional empathy responses']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",40.0,0.161093,"However, it is not established if this effect of oxytocin on emotional empathy is due to altered visual attention toward different components of the stimulus pictures or an enhanced empathic response.","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Le', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Kou', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Meina', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00803']
2564,32848669,Punishment Feedback Impairs Memory and Changes Cortical Feedback-Related Potentials During Motor Learning.,"Reward and punishment have demonstrated dissociable effects on motor learning and memory, which suggests that these reinforcers are differently processed by the brain. To test this possibility, we use electroencephalography to record cortical neural activity after the presentation of reward and punishment feedback during a visuomotor rotation task. Participants were randomly placed into Reward, Punishment, or Control groups and performed the task under different conditions to assess the adaptation (learning) and retention (memory) of the motor task. These conditions featured an incongruent position between the cursor and the target, with the cursor trajectory, rotated 30° counterclockwise, requiring the participant to adapt their movement to hit the target. Feedback based on error magnitude was provided during the Adaptation condition in the form of a positive number (Reward) or negative number (Punishment), each representing a monetary gain or loss, respectively. No reinforcement or visual feedback was provided during the No Vision condition (retention). Performance error and event-related potentials (ERPs) time-locked to feedback presentation were calculated for each participant during both conditions. Punishment feedback reduced performance error and promoted faster learning during the Adaptation condition. In contrast, punishment feedback increased performance error during the No Vision condition compared to Control and Reward groups, which suggests a diminished motor memory. Moreover, the Punishment group showed a significant decrease in the amplitude of ERPs during the No Vision condition compared to the Adaptation condition. The amplitude of ERPs did not change in the other two groups. These results suggest that punishment feedback impairs motor retention by altering the neural processing involved in memory encoding. This study provides a neurophysiological underpinning for the dissociative effects of punishment feedback on motor learning.",2020,Performance error and event-related potentials (ERPs) time-locked to feedback presentation were calculated for each participant during both conditions.,[],"['randomly placed into Reward, Punishment, or Control groups and performed the task under different conditions to assess the adaptation (learning) and retention (memory) of the motor task', 'punishment feedback']","['Punishment Feedback Impairs Memory and Changes Cortical Feedback-Related Potentials During Motor Learning', 'motor memory', 'amplitude of ERPs', 'performance error', 'Performance error and event-related potentials (ERPs) time-locked to feedback presentation', 'visual feedback', 'motor retention']",[],"[{'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0561782', 'cui_str': 'Procedural memory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.025891,Performance error and event-related potentials (ERPs) time-locked to feedback presentation were calculated for each participant during both conditions.,"[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hill', 'Affiliation': 'Kinesiology and Physical Education, Northern Illinois University, Dekalb, IL, United States.'}, {'ForeName': 'Mason', 'Initials': 'M', 'LastName': 'Stringer', 'Affiliation': 'Biomedical Engineering, University of Mississippi, Oxford, MS, United States.'}, {'ForeName': 'Dwight E', 'Initials': 'DE', 'LastName': 'Waddell', 'Affiliation': 'Biomedical Engineering, University of Mississippi, Oxford, MS, United States.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Del Arco', 'Affiliation': 'Health, Exercise Science, and Recreation Management, University of Mississippi, Oxford, MS, United States.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00294']
2565,32848820,"Effect of a Blend of  Zingiber officinale  Roscoe and  Bixa orellana  L. Herbal Supplement on the Recovery of Delayed-Onset Muscle Soreness Induced by Unaccustomed Eccentric Resistance Training: A Randomized, Triple-Blind, Placebo-Controlled Trial.","Background


There is an increasing interest in the use of eccentric muscle exercise to improve physical condition, especially with regards to its health-related benefits. However, it is known that unaccustomed eccentric exercise causes muscle damage and delayed pain, commonly defined as ""delayed onset muscle soreness"" (DOMS). The efficacy of herbal preparations in subjects suffering from DOMS has been reported in a few previous studies with small or moderate outcome measures related to muscle recovery. The present study aimed to evaluate the effects of a polyherbal mixture containing whole  Zingiber officinale  Roscoe and  Bixa orellana  L., powders called ReWin(d), in young male athletes suffering from DOMS induced by a 1 h session of plyometric exercises.
Methods


Thirty-three young male athletes participated in this randomized, Triple-blind, placebo-controlled trial: 17 of them assigned to the ReWin(d) group and 16 of them to the placebo group. Creatine kinase (CK) was measured as a muscle damage marker, pain was assessed using the Visual Analog Scale (VAS), muscle performance was measured through half-squat exercise (HS) monitored with an accelerometer (Encoder), and heart rate variability (HRV) was monitored for 5 min with the subjects in the supine position. All determinations were performed before and after the eccentric session and 24, 48, and 72 h after the session.
Results


The eccentric exercise session caused an increase in CK at 24 and 48 h after exercise intervention in both groups ( p  < 0.001). There was no interaction between groups regarding muscle damage. The pain increased after the training session in both groups ( p  < 0.001), and a significant interaction was observed between groups at 48 h after exercise ( p  = 0.004). Lower limb muscular power showed a significant interaction between groups 24 h after exercise ( p  = 0.049); the placebo group showed a reduction in muscle power compared to the ReWin(d) group. The LF/HF ratio decreased significantly at 72 h after exercise in the herbal group but not in the placebo group.
Conclusion


The herbal supplement maintained the maximum power of the lower limbs and attenuated muscle pain.
Clinical Trial Registration


www.ClinicalTrials.gov, identifier NCT03961022.",2020,"The pain increased after the training session in both groups ( p  < 0.001), and a significant interaction was observed between groups at 48 h after exercise ( p  = 0.004).","['Delayed-Onset Muscle Soreness Induced by Unaccustomed Eccentric Resistance Training', 'young male athletes suffering from DOMS induced by a 1 h session of plyometric exercises', 'Methods\n\n\nThirty-three young male athletes', 'subjects suffering from DOMS']","['polyherbal mixture containing whole  Zingiber officinale  Roscoe and  Bixa orellana  L., powders called ReWin(d', 'herbal preparations', 'eccentric exercise session', 'placebo', 'eccentric muscle exercise', 'Placebo']","['LF/HF ratio', 'Visual Analog Scale (VAS), muscle performance was measured through half-squat exercise (HS) monitored with an accelerometer (Encoder), and heart rate variability (HRV', 'CK', 'maximum power of the lower limbs and attenuated muscle pain', 'muscle power', 'Creatine kinase (CK', 'Lower limb muscular power', 'pain']","[{'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C1026070', 'cui_str': 'Bixa'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",33.0,0.294992,"The pain increased after the training session in both groups ( p  < 0.001), and a significant interaction was observed between groups at 48 h after exercise ( p  = 0.004).","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Dominguez-Balmaseda', 'Affiliation': 'Research Group on Nutrition, Physical Activity and Health, Faculty of Biomedical Sciences Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez-Vega', 'Affiliation': 'Research Group on Exercise, Health and Applied Biomarkers, Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Larrosa', 'Affiliation': 'Research Group on Nutrition, Physical Activity and Health, Faculty of Biomedical Sciences Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Alejandro F', 'Initials': 'AF', 'LastName': 'San Juan', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences-INEF, Universidad Polit cnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Issaly', 'Affiliation': 'Nicolas Issaly, Valencia, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Moreno-Pérez', 'Affiliation': 'Departamento de Educación, Métodos de Investigación y Evaluación, Universidad Pontificia de Comillas, Instituto Católico de Artes e Industrias-Instituto Católico de Administración y Dirección de Empresas, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Burgos', 'Affiliation': 'Research Group on Exercise, Health and Applied Biomarkers, Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Sillero-Quintana', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences-INEF, Universidad Polit cnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gonzalez', 'Affiliation': 'Research Group on Exercise, Health and Applied Biomarkers, Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bas', 'Affiliation': 'Research Group on Exercise, Health and Applied Biomarkers, Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Roller', 'Affiliation': 'Natural Origins, Lozanne, France.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Research Group on Exercise, Health and Applied Biomarkers, Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}]",Frontiers in physiology,['10.3389/fphys.2020.00826']
2566,32848830,Short-Term Ketogenic Diet Improves Abdominal Obesity in Overweight/Obese Chinese Young Females.,"The purpose of this study was to examine the effects of a short-term ketogenic diet (KD) on body composition and cardiorespiratory fitness (CRF) in overweight/obese Chinese females. Twenty young females [age: 21.0 ± 3.7 years, weight: 65.5 ± 7.7 kg, body mass index (BMI): 24.9 ± 2.7 kg⋅m -2 ] consumed 4 weeks of a normal diet (ND) as a baseline and then switched to a low-carbohydrate, high-fat, and adequate protein KD for another 4 weeks. With the same daily caloric intake, the proportions of energy intake derived from carbohydrates, proteins, and fats were changed from 44.0 ± 7.6%, 15.4 ± 3.3%, 39.6 ± 5.8% in ND to 9.2 ± 4.8%, 21.9 ± 3.4%, and 69.0 ± 5.4% in KD. The results showed that, without impairing the CRF level, the 4-week KD intervention significantly reduced body weight (-2.9 kg), BMI (-1.1 kg⋅m -2 ), waist circumference (-4.0 cm), hip circumference (-2.5 cm), and body fat percentage (-2.0%). Moreover, fasting leptin level was lowered significantly, and serum levels of inflammatory markers (i.e., TNF-α and MCP-1) were unchanged following KD. These findings suggest that KD can be used as a rapid and effective approach to lose weight and reduce abdominal adiposity in overweight/obese Chinese females without exacerbating their CRF.",2020,"Moreover, fasting leptin level was lowered significantly, and serum levels of inflammatory markers (i.e., TNF-α and MCP-1) were unchanged following KD.","['Overweight/Obese Chinese Young Females', 'overweight/obese Chinese females', 'Twenty young females [age: 21.0 ± 3.7 years, weight: 65.5 ± 7.7 kg, body mass index (BMI): 24.9 ± 2.7 kg⋅m -2 ']","['Short-Term Ketogenic Diet', 'short-term ketogenic diet (KD']","['body fat percentage', 'abdominal adiposity', 'body composition and cardiorespiratory fitness (CRF', 'waist circumference', 'fasting leptin level', 'body weight', 'serum levels of inflammatory markers (i.e., TNF-α and MCP-1', 'CRF level', 'Abdominal Obesity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}]",20.0,0.0181898,"Moreover, fasting leptin level was lowered significantly, and serum levels of inflammatory markers (i.e., TNF-α and MCP-1) were unchanged following KD.","[{'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Faculty of Education, University of Macau, Macao, China.'}, {'ForeName': 'Shengyan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Institute of Physical Education, Huzhou University, Huzhou, China.'}, {'ForeName': 'Qingde', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'College of Physical Education, Hebei Normal University, Shijiazhuang, China.'}, {'ForeName': 'Tomas K', 'Initials': 'TK', 'LastName': 'Tong', 'Affiliation': 'Department of Physical Education, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao, China.'}]",Frontiers in physiology,['10.3389/fphys.2020.00856']
2567,32848844,Effects of Equal Volume Heavy-Resistance Strength Training Versus Strength Endurance Training on Physical Fitness and Sport-Specific Performance in Young Elite Female Rowers.,"Strength training is an important means for performance development in young rowers. The purpose of this study was to examine the effects of a 9-week equal volume heavy-resistance strength training (HRST) versus strength endurance training (SET) in addition to regular rowing training on primary (e.g., maximal strength/power) and secondary outcomes (e.g., balance) in young rowers. Twenty-six female elite adolescent rowers were assigned to an HRST ( n  = 12; age: 13.2 ± 0.5 yrs; maturity-offset: +2.0 ± 0.5 yrs) or a SET group ( n  = 14; age: 13.1 ± 0.5 yrs; maturity-offset: +2.1 ± 0.5 yrs). HRST and SET comprised lower- (i.e., leg press/knee flexion/extension), upper-limbs (i.e., bench press/pull; lat-pull down), and complex exercises (i.e., rowing ergometer). HRST performed four sets with 12 repetitions per set at an intensity of 75-95% of the one-repetition maximum (1-RM). SET conducted four sets with 30 repetitions per set at 50-60% of the 1-RM. Training volume was matched for overall repetitions × intensity × training per week. Pre-post training, tests were performed for the assessment of primary [i.e., maximal strength (e.g., bench pull/knee flexion/extension 1-RM/isometric handgrip test), muscle power (e.g., medicine-ball push test, triple hop, drop jump, and countermovement jump), anaerobic endurance (400-m run), sport-specific performance (700-m rowing ergometer trial)] and secondary outcomes [dynamic balance (Y-balance test), change-of-direction (CoD) speed (multistage shuttle-run test)]. Adherence rate was >87% and one athlete of each group dropped out. Overall, 24 athletes completed the study and no test or training-related injuries occurred. Significant group × time interactions were observed for maximal strength, muscle power, anaerobic endurance, CoD speed, and sport-specific performance ( p  ≤ 0.05; 0.45 ≤  d  ≤ 1.11).  Post hoc  analyses indicated larger gains in maximal strength and muscle power following HRST ( p  ≤ 0.05; 1.81 ≤  d  ≤ 3.58) compared with SET ( p  ≤ 0.05; 1.04 ≤  d  ≤ 2.30). Furthermore, SET ( p  ≤ 0.01;  d  = 2.08) resulted in larger gains in sport-specific performance compared with HRST ( p  < 0.05;  d  = 1.3). Only HRST produced significant pre-post improvements for anaerobic endurance and CoD speed ( p  ≤ 0.05; 1.84 ≤  d  ≤ 4.76). In conclusion, HRST in addition to regular rowing training was more effective than SET to improve selected measures of physical fitness (i.e., maximal strength, muscle power, anaerobic endurance, and CoD speed) and SET was more effective than HRST to enhance sport-specific performance gains in female elite young rowers.",2020,Post hoc  analyses indicated larger gains in maximal strength and muscle power following HRST ( p  ≤ 0.05; 1.81 ≤  d  ≤ 3.58) compared with SET ( p  ≤ 0.05; 1.04 ≤  d  ≤ 2.30).,"['Twenty-six female elite adolescent rowers', 'Young Elite Female Rowers', 'female elite young rowers', 'young rowers']","['HRST', 'Strength training', '9-week equal volume heavy-resistance strength training (HRST) versus strength endurance training (SET', 'regular rowing training', 'Equal Volume Heavy-Resistance Strength Training Versus Strength Endurance Training']","['larger gains in sport-specific performance', 'Adherence rate', 'physical fitness (i.e., maximal strength, muscle power, anaerobic endurance, and CoD speed', 'Physical Fitness and Sport-Specific Performance', 'anaerobic endurance and CoD speed', 'maximal strength (e.g., bench pull/knee flexion/extension 1-RM/isometric handgrip test), muscle power (e.g., medicine-ball push test, triple hop, drop jump, and countermovement jump), anaerobic endurance (400-m run), sport-specific performance (700-m rowing ergometer trial)] and secondary outcomes [dynamic balance (Y-balance test), change-of-direction (CoD) speed (multistage shuttle-run test', 'maximal strength and muscle power following HRST', 'maximal strength, muscle power, anaerobic endurance, CoD speed, and sport-specific performance']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",,0.0129998,Post hoc  analyses indicated larger gains in maximal strength and muscle power following HRST ( p  ≤ 0.05; 1.81 ≤  d  ≤ 3.58) compared with SET ( p  ≤ 0.05; 1.04 ≤  d  ≤ 2.30).,"[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Thiele', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognitive Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Prieske', 'Affiliation': 'Division of Exercise and Movement, University of Applied Sciences for Sports and Management Potsdam, Potsdam, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lesinski', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognitive Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognitive Sciences, University of Potsdam, Potsdam, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2020.00888']
2568,32848848,Eight-Week Low-Intensity Squat Training at Slow Speed Simultaneously Improves Knee and Hip Flexion and Extension Strength.,"Considering that the squat exercise requires flexion and extension of the knee and hip joints, a resistance training program based on squat exercises should efficiently increase the flexion and extension strength of both the knee and hip. To our knowledge, however, no study has simultaneously investigated the effects of squat training on both flexion and extension strength in both the knee and hip. Low-intensity squat exercises at slow speeds can be expected to effectively and safely improve knee and hip flexion and extension strength in a wide range of individuals. This study aimed to clarify whether knee and hip flexion and extension strength improved after an 8-week low-intensity squat training program at slow speed. Twenty-four untrained young men were randomly assigned to a training or control group. Participants in the training group performed 40% one-repetition maximum parallel squats at slow speed (4 s for concentric/eccentric actions), 3 days per week for 8 weeks. Before and after the intervention, isometric peak torque of the knee and hip flexors and extensors during maximal voluntary contraction (MVC) was determined. For the knee flexors and extensors, muscle volume was also measured. There were significant training-induced increases in peak torque ( P  < 0.05). The training effects on knee and hip extension torque (effect size = 0.36-0.38) were higher than those on knee and hip flexion torque (effect size = 0.09-0.13). The squat training used here increased both knee and hip flexion and extension strength, but the training effects on the flexion strength were less than those on the extension strength. Regarding the knee extensors, a significant training-related increase in muscle volume was found ( P  < 0.05) without neuromuscular adaptations. In addition, there were significant correlations between the training-induced increases in muscle volume and peak torque of KE. These results suggest that muscle hypertrophy may be responsible for increased muscle strength of the knee extensors after an 8-week low-intensity squat training program at slow speed.",2020,The training effects on knee and hip extension torque (effect size = 0.36-0.38) were higher than those on knee and hip flexion torque (effect size = 0.09-0.13).,['Twenty-four untrained young men'],"['training or control group', 'squat exercise', 'Eight-Week Low-Intensity Squat Training at Slow Speed', 'Low-intensity squat exercises', 'squat training']","['flexion and extension strength', 'isometric peak torque of the knee and hip flexors and extensors during maximal voluntary contraction (MVC', 'Knee and Hip Flexion and Extension Strength', 'muscle volume and peak torque of KE', 'flexion strength', 'muscle volume', 'knee and hip extension torque', 'knee and hip flexion and extension strength', 'peak torque']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",24.0,0.0140907,The training effects on knee and hip extension torque (effect size = 0.36-0.38) were higher than those on knee and hip flexion torque (effect size = 0.09-0.13).,"[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Akagi', 'Affiliation': 'College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Hirata', 'Affiliation': 'Graduate School of Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Imaizumi', 'Affiliation': 'College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tanimoto', 'Affiliation': 'Graduate School of Health Management, Keio University, Fujisawa, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, Tokyo, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Ema', 'Affiliation': 'School of Management, Shizuoka Sangyo University, Iwata, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Hirata', 'Affiliation': 'Graduate School of Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}]",Frontiers in physiology,['10.3389/fphys.2020.00893']
2569,32848854,Circulating and Adipose Tissue miRNAs in Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training.,"MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression post-transcriptionally. In women with polycystic ovary syndrome (PCOS), several miRNAs are differentially expressed compared to women without PCOS, suggesting a role for miRNAs in PCOS pathophysiology. Exercise training modulates miRNA abundance and is primary lifestyle intervention for women with PCOS. Accordingly, we measured the expression of eight circulating miRNAs selected  a priori  along with miRNA expression from gluteal and abdominal adipose tissue (AT) in 12 women with PCOS and 12 women matched for age and body mass index without PCOS. We also determined the miRNA expression ""signatures"" before and after high-intensity interval training (HIT) in 42 women with PCOS randomized to either: (1) low-volume HIT (LV-HIT, 10 × 1 min work bouts at maximal, sustainable intensity,  n  = 13); (2) high-volume HIT (HV-HIT, 4 × 4 min work bouts reaching 90-95% of maximal heart rate,  n  = 14); or (3) non-exercise control (Non-Ex,  n  = 15). Both HIT groups trained three times/week for 16 weeks. miRNAs were extracted from plasma, gluteal and abdominal AT, and quantified via a customized plate array containing eight miRNAs associated with PCOS and/or exercise training responses. Basal expression of circulating miRNA-27b (c-miR-27b), implicated in fatty acid metabolism, adipocyte differentiation and inflammation, was 1.8-fold higher in women with compared to without PCOS ( P  = 0.006) despite no difference in gluteal or abdominal AT miR-27b expression. Only the HV-HIT protocol increased peak oxygen uptake (VO 2 peak L/min; 9%,  P  = 0.008). There were no changes in body composition. In LV-HIT, but not HV-HIT, the expression of c-miR-27b decreased (0.5-fold,  P  = 0.007). None of the remaining seven circulating miRNAs changed in LV-HIT, nor was the expression of gluteal or abdominal AT miRNAs altered. Despite increased cardiorespiratory fitness, HV-HIT did not alter the expression of any circulating, gluteal or abdominal AT miRNAs. We conclude that women with PCOS have a higher basal expression of c-miR-27b compared to women without PCOS and that 16 weeks of LV-HIT reduces the expression of this miRNA in women with PCOS. Intense exercise training had little effect on the abundance of the selected miRNAs within subcutaneous AT depots in women with PCOS.",2020,"Only the HV-HIT protocol increased peak oxygen uptake (VO 2 peak L/min; 9%,  P  = 0.008).","['women with polycystic ovary syndrome (PCOS', '12 women with PCOS and 12 women matched for age and body mass index without PCOS', '42 women with PCOS', 'women with PCOS', 'Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training']","['Exercise training', 'Intense exercise training', 'high-volume HIT (HV-HIT, 4 × 4 min work bouts reaching 90-95% of maximal heart rate,  n  = 14); or (3) non-exercise control']","['peak oxygen uptake', 'expression of any circulating, gluteal or abdominal AT miRNAs', 'basal expression of c-miR-27b', 'cardiorespiratory fitness, HV-HIT', 'expression of c-miR-27b', 'Basal expression of circulating miRNA-27b', 'fatty acid metabolism, adipocyte differentiation and inflammation', 'body composition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",12.0,0.0672977,"Only the HV-HIT protocol increased peak oxygen uptake (VO 2 peak L/min; 9%,  P  = 0.008).","[{'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Lionett', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Ida A', 'Initials': 'IA', 'LastName': 'Kiel', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Donny M', 'Initials': 'DM', 'LastName': 'Camera', 'Affiliation': 'Department of Health and Medical Sciences, Swinburne University of Technology, Melbourne, VIC, Australia.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': ""Department of Obstetrics and Gynecology, St. Olav's Hospital, Trondheim, Norway.""}, {'ForeName': 'Evelyn B', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Moholdt', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Frontiers in physiology,['10.3389/fphys.2020.00904']
2570,32848855,The Recovery of Muscle Spindle Sensitivity Following Stretching Is Promoted by Isometric but Not by Dynamic Muscle Contractions.,"It is often suggested that stretching-related changes in performance can be partially attributed to stretching-induced neural alterations. Recent evidence though shows that neither spinal nor cortico-spinal excitability are susceptible of a long-lasting effect and only the amplitude of stretch or tap reflex (TR) is reduced up to several minutes. Since afferents from muscle spindles contribute to voluntary muscle contractions, muscle stretching could be detrimental to muscle performance. However, the inhibition of muscle spindle sensitivity should be reversed as soon as the stretched muscle contracts again, due to α-γ co-activation. The present work evaluated which type of muscle contraction (static or dynamic) promotes the best recovery from the inhibition in spindle sensitivity following static stretching. Fifteen students were tested for TR at baseline and after 30 s maximal individual static stretching of the ankle plantar flexors followed by one of three randomized interventions (isometric plantar flexor MVC, three counter movement jumps, and no contraction/control). Ten TRs before and 20 after the procedures were induced with intervals of 30 s up to 10 min after static stretching. The size of the evoked TRs (peak to peak amplitude of the EMG signal) following stretching without a subsequent contraction (control) was on average reduced by 20% throughout the 10 min following the intervention and did not show a recovery trend. Significant decrease in relation to baseline were observed at 9 of the 20 time points measured. After MVC of plantar flexors, TR recovered immediately showing no differences with baseline at none of the investigated time points. Following three counter movement jumps it was observed a significant 34.4% group average inhibition ( p  < 0.0001) at the first time point. This effect persisted for most of the participants for the next measurement (60 s after intervention) with an average reduction of 23.4% ( p  = 0.008). At the third measurement, 90 s after the procedure, the reflexes were on average still 21.4% smaller than baseline, although significant level was not reached ( p  = 0.053). From 120 s following the intervention, the reflex was fully recovered. This study suggests that not every type of muscle contraction promotes a prompt recovery of a stretch-induced inhibition of muscle spindle sensitivity.",2020,Following three counter movement jumps it was observed a significant 34.4% group average inhibition ( p  < 0.0001) at the first time point.,['Fifteen students'],[],"['size of the evoked TRs', 'Recovery of Muscle Spindle Sensitivity', 'amplitude of stretch or tap reflex (TR']","[{'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0266427', 'cui_str': 'Testicular regression syndrome'}, {'cui': 'C0027871', 'cui_str': 'Muscle spindle'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}]",15.0,0.0336029,Following three counter movement jumps it was observed a significant 34.4% group average inhibition ( p  < 0.0001) at the first time point.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Budini', 'Affiliation': 'Institute for Sport Science, Graz University, Graz, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Rafolt', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Christova', 'Affiliation': 'Otto Loewi Research Center, Physiology Section, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Gallasch', 'Affiliation': 'Otto Loewi Research Center, Physiology Section, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Tilp', 'Affiliation': 'Institute for Sport Science, Graz University, Graz, Austria.'}]",Frontiers in physiology,['10.3389/fphys.2020.00905']
2571,32848896,Methodological Biases in CBT Trial-Commentary: Modular Cognitive-Behavioral Therapy for Affective Symptoms in Young Individuals at Ultra-High Risk of First Episode of Psychosis: Randomized Controlled Trial.,,2020,,['Young Individuals at Ultra-High Risk of First Episode of Psychosis'],['Cognitive-Behavioral Therapy'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0628906,,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fusar-Poli', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Radua', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McKenna', 'Affiliation': 'Investigación Germanes Hospitalàries Research Foundation, Barcelona, Spain.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Laws', 'Affiliation': 'Department of Psychology and Sports Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Jauhar', 'Affiliation': 'National Institute for Health Research, Maudsley Biomedical Research Centre, South London and Maudsley NHS Foundation Trust, London, United Kingdom.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00394']
2572,32848901,Effect of Process-Based Multi-Task Cognitive Training Program on Executive Function in Older Adults With Mild Cognitive Impairment: Study Rationale and Protocol Design for a Randomized Controlled Trial.,"Introduction


Recent research from both human and animal studies confirms that cognitive training gains a considerable effect on multiple cognitive domains in older adults with mild cognitive impairment. Previous studies have yet paid scant attention to executive function training. Little is known about whether this specific benefit translates to maintaining long-term effectiveness and transfer effects are. This study is designed as an effort to address this issue.
Objective


The program aimed to evaluate the effect of process-based multi-task cognitive training on executive function and further explore its long-term effects and transfer effects in older adults with MCI. Furthermore, we will explore the neural correlates latent the changed performances underlying the cognitive intervention.
Methods


This program is a single-blinded, randomized, prospective clinical trial to test the effect of process-based multi-task cognitive training in older adults with MCI. Ninety participants with MCI will be recruited and randomly assigned to the cognitive training group (n=45) and the wait-list control group (n=45). The cognitive training group will receive 10 weeks of process-based multi-task cognitive training and health education twice a week, at 40~60 min per session. While the wait-list control group will only receive 10 weeks of health education during the research period. The effect is measured using the executive function, neuropsychological assessment performance and related brain activity assessed with electroencephalogram parameters (slowness and complexity of the EEG) at baseline, after 10 weeks of training, and a 3-month follow-up.
Results


The study is currently ongoing. Recruitment began in March 2019 and will conclude at the end of 2020. Effects of the process-based multi-task cognitive training on executive function in older adults with MCI will be described in intention-to-treat analysis and protocol set principle. We will also explore the potential long-term effects and transfer effects.
Discussion


If a process-based multi-task cognitive training program results in positive changes to executive function in older adults with MCI, this might provide a viable and potential approach to delay the cognitive decline.  Clinical Trial Registration:  ChiCTR1900020585. Registered on January 09, 2019. http://www.chictr.org.cn/showproj.aspx?proj=34664.",2020,"If a process-based multi-task cognitive training program results in positive changes to executive function in older adults with MCI, this might provide a viable and potential approach to delay the cognitive decline.  ","['Older Adults With Mild Cognitive Impairment', 'older adults with mild cognitive impairment', 'Ninety participants with MCI', 'older adults with MCI']","['cognitive training group will receive 10 weeks of process-based multi-task cognitive training and health education', 'cognitive training group (n=45) and the wait-list control group', 'Process-Based Multi-Task Cognitive Training Program', 'process-based multi-task cognitive training']","['executive function', 'Executive Function', 'executive function, neuropsychological assessment performance and related brain activity assessed with electroencephalogram parameters (slowness and complexity of the EEG']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0560005', 'cui_str': 'mCi'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",90.0,0.0683467,"If a process-based multi-task cognitive training program results in positive changes to executive function in older adults with MCI, this might provide a viable and potential approach to delay the cognitive decline.  ","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Centre Hospital, Huzhou, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Centre Hospital, Huzhou, China.'}, {'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Ge', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Centre Hospital, Huzhou, China.'}, {'ForeName': 'Xiaoshen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Centre Hospital, Huzhou, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Huzhou Rehabilitation Hospital, Huzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of General Medicine, Community Health Service Center of Renhuangshan, Huzhou, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00655']
2573,32848910,Monetary Incentives Increase Metacognitive Confidence in Source Memory Performance in Patients With Schizophrenia.,"Background


Contemporary psychiatric research focuses its attention on the patient's dysfunction of metacognition in relation to the basic cognitive processes of mental activity. The current study investigated dysfunctional metacognition in relation to self-monitoring of memory in patients diagnosed with schizophrenia. Dysfunctions in metacognition were examined by focusing on two types of metacognitive measures: post-decision wagering (PDW) scale and confidence ratings (CR) scale (CR).
Objectives


The research employed an action-memory task that required patients with schizophrenia (N = 39) and healthy controls (N = 50) to evaluate their metacognition by categorizing self-monitoring actions (imagined vs. performed actions) either with PDW or CR. It was hypothesized that metacognition in self-monitoring activity in patients diagnosed with schizophrenia is improved by imaginary monetary incentives.
Material and Methods


To test this hypothesis, participants were asked to memorize actions either performed or imagined during the first phase of the experiment. The second phase was to identify previous actions as performed, imagined or new, and then to express confidence using two measures of metacognition (CR or PDW scales) that were randomly allocated to participants.
Results


Our study showed reduced performance in the action memory task for patients with schizophrenia, although there were no group differences in confidence measures when assessing self-monitoring actions. In particular, irrespective of the diagnosis, no differences in confidence measures for correct responses were found in the case of the PDW and CR scales. We also observed that metacognitive judgements were more accurate for incorrect responses when both groups used monetary incentives to reveal their metacognition.
Conclusions


Our findings suggest that monetary incentives improve accuracy of metacognition among both patients and healthy controls. This accuracy-enhancing effect of monetary incentives on metacognition was possibly a result of motivational processes, including aversion to loss. The paper discusses the potential application of PDW in therapeutic metacognitive training for patients with schizophrenia.",2020,"Our study showed reduced performance in the action memory task for patients with schizophrenia, although there were no group differences in confidence measures when assessing self-monitoring actions.","['patients with schizophrenia', 'Patients With Schizophrenia', 'patients with schizophrenia (N = 39) and healthy controls (N = 50', 'patients diagnosed with schizophrenia']","['PDW or CR', 'PDW']","['decision wagering (PDW) scale and confidence ratings (CR) scale (CR', 'accuracy of metacognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}]",,0.0168022,"Our study showed reduced performance in the action memory task for patients with schizophrenia, although there were no group differences in confidence measures when assessing self-monitoring actions.","[{'ForeName': 'Remigiusz', 'Initials': 'R', 'LastName': 'Szczepanowski', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Wroclaw Medical University, Wrocław, Poland.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Cichoń', 'Affiliation': 'Department of Psychology, WSB University in Torun, Torun, Poland.'}, {'ForeName': 'Aleksandra Helena', 'Initials': 'AH', 'LastName': 'Pasieczna', 'Affiliation': 'Department of Finance and Accounting, Kozminski University, Wrocław, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Gawęda', 'Affiliation': 'Institute of Psychology, Polish Academy of Sciences, Warsaw, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rosińczuk', 'Affiliation': 'Department of Clinical Nursing, Faculty of Health Sciences, Wroclaw Medical University, Wrocław, Poland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00725']
2574,32849046,How Does Courtroom Broadcasting Influence Public Confidence in Justice? The Mediation Effect of Vicarious Interpersonal Treatment.,"The present study aimed to examine whether the applied practice of cameras in courtrooms plays a positive role in public confidence in legal authorities and how such impact may occur from the perspectives of the Group Value Model and the surrogacy effect. A convenience sample of 170 college students participated in this experiment. The control group read the written judgment of a civil case published online while the experimental group read the same judgment and watched the court trial video of that case. The overarching mediation model confirmed that there was a significant and indirect influence of video watching on confidence in justice in general. The key underlying mechanisms of this impact were the positive perception of the interpersonal treatment by the judge as well as the perceived fairness of the procedure. This study contributes to the currently limited research examining whether and, if so, how courtroom broadcasting promotes public trust through obtaining empirical evidence. It also expands the application of the Group Value Model to a vicarious interaction setting and provides evidence of the surrogacy effect in a civil legal context.",2020,The overarching mediation model confirmed that there was a significant and indirect influence of video watching on confidence in justice in general.,['170 college students participated in this experiment'],"['Vicarious Interpersonal Treatment', 'control group read the written judgment of a civil case published online while the experimental group read the same judgment and watched the court trial video of that case', 'video watching']",[],"[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",[],170.0,0.0410459,The overarching mediation model confirmed that there was a significant and indirect influence of video watching on confidence in justice in general.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'School of Media and Communication, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Media and Communication, Shanghai Jiao Tong University, Shanghai, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01766']
2575,32849059,Longing for the Past and Longing for the Future: A Phenomenological Assessment of the Relation Between Temporal Focus and Readiness to Change Among People Living With Addiction.,"At present, the dominant motivational strategy to facilitate behavior change among those living with addiction is to focus one's attention on the better possible future that may result from cutting down or cessation. However, research is now emerging that suggests nostalgic reverie (i.e., sentimental longing) for life lived before addiction can also motivate behavior change. In the current research, we explore the conditions in which longing for a better future free of addiction and longing for one's past that was free of addition might motivate change. To this end, we assessed first-person experiential narratives of problem gamblers to better understand how they feel about their past or future without gambling, and how those feelings may relate to motivation to change. Problem gamblers were randomly assigned to either write about their lived past before gambling ( n  = 31) or their expected future without gambling ( n  = 26). Each narrative was systematically examined to identify recurrent themes and cluster these narratives according to similarly expressed themes. In the past condition, participants reported their life before gambling was either positive (Cluster P1) or difficult (Cluster P2). Gamblers with a positive past described how their life, character, close relationships, and the activities they engaged in before gambling were more meaningful. Importantly, these gamblers also reported feeling more nostalgic for life without gambling and were more ready to change their behavior than gamblers with a difficult past. In the future condition, participants were either positive (Cluster F1) or ambivalent (Cluster F2) about a future free from gambling. Gamblers who expected a positive future described how they expect their emotions, finances, and the activities they will engage in to be more positive without gambling. Compared to those ambivalent about their future, these gamblers also reported a future without addiction to be more vivid and had more desire to change their behavior, but there were no between-cluster differences in readiness to change. These findings demonstrate unique differences in how gamblers perceive their past and future without gambling, and shed a novel light on how each temporal focus might motivate behavior change among those living with addiction.",2020,"Compared to those ambivalent about their future, these gamblers also reported a future without addiction to be more vivid and had more desire to change their behavior, but there were no between-cluster differences in readiness to change.","['People Living With Addiction', 'Problem gamblers']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]",[],[],,0.0309039,"Compared to those ambivalent about their future, these gamblers also reported a future without addiction to be more vivid and had more desire to change their behavior, but there were no between-cluster differences in readiness to change.","[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Salmon', 'Affiliation': 'Department of Psychology, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Michael J A', 'Initials': 'MJA', 'LastName': 'Wohl', 'Affiliation': 'Department of Psychology, Carleton University, Ottawa, ON, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01794']
2576,32849136,Investigating Science Together: Inquiry-Based Training Promotes Scientific Conversations in Parent-Child Interactions.,"This study examined the effects of two pedagogical training approaches on parent-child dyads' discussion of scientific content in an informal museum setting. Forty-seven children (mean age = 5.43) and their parents were randomly assigned to training conditions where an experimenter modeled one of two different pedagogical approaches when interacting with the child and a science-based activity: (1) a scientific inquiry-based process or (2) a scientific statement-sharing method. Both approaches provided the same information about scientific mechanisms but differed in the process through which that content was delivered. Immediately following the training, parents were invited to model the same approach with their child with a novel science-based activity. Results indicated significant differences in the process through which parents prompted discussion of the targeted information content: when talking about causal scientific concepts, parents in the scientific inquiry condition were significantly more likely to pose questions to their child than parents in the scientific statements condition. Moreover, children in the scientific inquiry condition were marginally more responsive to parental causal talk and provided significantly more scientific content in response. These findings provide initial evidence that training parents to guide their children using scientific inquiry-based approaches in informal learning settings can encourage children to participate in more joint scientific conversations.",2020,"Results indicated significant differences in the process through which parents prompted discussion of the targeted information content: when talking about causal scientific concepts, parents in the scientific inquiry condition were significantly more likely to pose questions to their child than parents in the scientific statements condition.",['Forty-seven children (mean age = 5.43) and their parents'],"['training conditions where an experimenter modeled one of two different pedagogical approaches when interacting with the child and a science-based activity: (1) a scientific inquiry-based process or (2) a scientific statement-sharing method', 'pedagogical training approaches']",[],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2004436', 'cui_str': 'Activity therapy'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],47.0,0.0150864,"Results indicated significant differences in the process through which parents prompted discussion of the targeted information content: when talking about causal scientific concepts, parents in the scientific inquiry condition were significantly more likely to pose questions to their child than parents in the scientific statements condition.","[{'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Chandler-Campbell', 'Affiliation': 'Wheelock College of Education and Applied Human Development, Boston University, Boston, MA, United States.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Leech', 'Affiliation': 'School of Education, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Kathleen H', 'Initials': 'KH', 'LastName': 'Corriveau', 'Affiliation': 'Wheelock College of Education and Applied Human Development, Boston University, Boston, MA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01934']
2577,32849142,On-Field Perceptual-Cognitive Training Improves Peripheral Reaction in Soccer: A Controlled Trial.,"Abilities such as peripheral reaction are of special importance in soccer. Whether these abilities can be improved by sport-specific on-field interventions remains unclear. The aim of the present controlled trial was to investigate the effect of a soccer-specific perceptual-cognitive on-field training on peripheral reaction of highly talented soccer players aged 12-13 years.  N  = 38 male elite athletes from young talent centers were allocated to an intervention ( n  = 19) and a control group (CG) ( n  = 19). Computer-based peripheral perception tests were conducted before and after intervention. Combining a sport-specific and a juggling task, the intervention was performed once a week (8 weeks, 20 min per week) in addition to team training. The CG exclusively underwent usual team training. Analyses show significant differences between the two groups for peripheral reaction time (PRT), with significant improvements for the intervention group and none for the CG. Furthermore, results indicate that improvements in peripheral reaction might be due to changes in the reaction time of right-footed players. Future studies should be conducted to clarify the effect of sport-specific on-field training approaches on PRT. These analyses should consider the influence of lateralization on effectivity of perceptual-cognitive on-field training approaches.",2020,"Analyses show significant differences between the two groups for peripheral reaction time (PRT), with significant improvements for the intervention group and none for the CG.","['highly talented soccer players aged 12-13 years', 'Soccer', '38 male elite athletes from young talent centers']","['Field Perceptual-Cognitive Training', 'soccer-specific perceptual-cognitive on-field training', 'control group (CG']",['peripheral reaction time (PRT'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0039269', 'cui_str': 'Talent'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0020687', 'cui_str': 'Hypoxanthine phosphoribosyltransferase'}]",38.0,0.0173798,"Analyses show significant differences between the two groups for peripheral reaction time (PRT), with significant improvements for the intervention group and none for the CG.","[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Schumacher', 'Affiliation': 'Faculty of Psychology and Human Movement, Institute of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Reer', 'Affiliation': 'Faculty of Psychology and Human Movement, Institute of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Klaus-Michael', 'Initials': 'KM', 'LastName': 'Braumann', 'Affiliation': 'Faculty of Psychology and Human Movement, Institute of Human Movement Science, University of Hamburg, Hamburg, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01948']
2578,32849150,Body Matters in Emotion: Restricted Body Movement and Posture Affect Expression and Recognition of Status-Related Emotions.,"Embodiment theory suggests that we use our own body and experiences to simulate information from other people's bodies and faces to understand their emotions. A natural consequence of embodied theory is that our own current position and state contributes to this emotional processing. Testing non-disabled individuals, we investigated whether restricted body posture and movement influenced the production and recognition of nonverbal, dynamic emotional displays in able-bodied participants. In Experiment 1, participants were randomly assigned to either unrestricted or wheelchair-restricted (sitting, torso restrained) groups and nonverbally expressed six emotions (disgust, happiness, anger, fear, embarrassment, and pride) while being videotaped. After producing each emotion, they rated their confidence regarding how effectively they communicated that emotion. Videotaped emotional displays were coded for face, body, and face + body use. Based on naïve coders' scores, both unrestricted and wheelchair-restricted groups produced emotionally congruent face and body movements and both groups were equally confident in their communication effectiveness. Using videos from Experiment 1, Experiment 2 tested non-disabled participants' ability to recognize emotions from unrestricted and wheelchair-restricted displays. Wheelchair-restricted displays showed an overall decline in recognition accuracy, but recognition was selectively impaired for the dominance-related emotions of disgust and anger. Consistent with embodied emotion theory, these results emphasize the importance of the body for emotion communication and have implications for social interactions between individuals with and without physical disabilities. Changes in nonverbal emotion signals from body restrictions may influence social interactions that rely on the communication of dominance-related social emotions.",2020,"Wheelchair-restricted displays showed an overall decline in recognition accuracy, but recognition was selectively impaired for the dominance-related emotions of disgust and anger.","['Testing non-disabled individuals', 'individuals with and without physical disabilities', 'Body Matters in Emotion']","['unrestricted or wheelchair-restricted (sitting, torso restrained) groups and nonverbally expressed six emotions (disgust, happiness, anger, fear, embarrassment, and pride) while being videotaped']",['Restricted Body Movement and Posture Affect Expression and Recognition of Status-Related Emotions'],"[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",6.0,0.0206075,"Wheelchair-restricted displays showed an overall decline in recognition accuracy, but recognition was selectively impaired for the dominance-related emotions of disgust and anger.","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Reed', 'Affiliation': 'Department of Psychological Science, Claremont McKenna College, Claremont, CA, United States.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Moody', 'Affiliation': 'Wyoming Institute for Disabilities (WIND), University of Wyoming, Laramie, WY, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mgrublian', 'Affiliation': 'Department of Psychological Science, Claremont McKenna College, Claremont, CA, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Assaad', 'Affiliation': 'Department of Psychological Science, Claremont McKenna College, Claremont, CA, United States.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Schey', 'Affiliation': 'Department of Psychology, Scripps College, Claremont, CA, United States.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'McIntosh', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01961']
2579,32848451,Establishing a Technique for Pectoral II-Block Catheter Insertion with Ultrasound Guidance: A Randomized Controlled Trial.,"Purpose


To assess the efficacy and safety of a modified technique for ultrasound-guided pectoral II block for postoperative pain control after mastectomy.
Methods


In this randomized controlled trial, patients were randomly allocated into two groups (40 patients each). Group I patients were subjected to ultrasound-guided pectoral II block with injection of 10 mL lidocaine 1% as a dissecting solution before attempting catheter insertion, while group II patients underwent the standard procedure without a dissecting solution. Measured outcomes included catheter visibility, pain, patient satisfaction, performance time, and complications.
Results


Compared with group II, group I had significantly lower median catheter-visibility scores, shorter block performance time, and fewer insertion attempts. Group I had a nonsignificantly higher rate of complications than group II.
Conclusion


The modified technique facilitated the procedure, shortened the catheter-insertion time, and showed higher patient satisfaction. However, it was associated with lower catheter visibility on ultrasonography. Further studies are required to confirm the present findings and assess the safety of the modified technique.",2020,"Group I had a nonsignificantly higher rate of complications than group II.
",[],"['standard procedure without a dissecting solution', 'Pectoral II-Block Catheter Insertion with Ultrasound Guidance', 'modified technique for ultrasound-guided pectoral II block', 'ultrasound-guided pectoral II block with injection of 10 mL lidocaine']","['efficacy and safety', 'catheter visibility, pain, patient satisfaction, performance time, and complications', 'rate of complications', 'lower catheter visibility on ultrasonography', 'median catheter-visibility scores, shorter block performance time, and fewer insertion attempts']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0554314', 'cui_str': 'Blocked catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.109693,"Group I had a nonsignificantly higher rate of complications than group II.
","[{'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Z', 'Initials': 'AZ', 'LastName': 'Fouad', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Amin', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Dobal', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Local and regional anesthesia,['10.2147/LRA.S262138']
2580,32762238,[Food/nutrition education in the teaching degree curriculum: a study on changes in knowledge and eating habits].,"Introduction


Introduction: basic training in healthy food-nutrition during teaching qualification training may be of interest for two reasons: it may lead to possible improvements in the knowledge and the dietary habits that will be transmitted in the future once professional practice starts. Objectives: to evaluate and seek to improve some healthy eating knowledge and habits that occur with educational intervention. Methods: the study, with pre- and post-test measures, took place over 4 months in three consecutive courses. A total of 258 teaching students with an average age of 21.4 ± 0.7 years voluntarily participated. Knowledge on food guides was assessed with qualitative analysis through a validated questionnaire (scale, 0 to 10). The evolution of healthy breakfast habits (using a 24-hour reminder) has also been analyzed by estimating the quality of the environment and the quality of Enkid foods (both scales from 0 to 3 points). Results: at the end of the educational intervention there were significant improvements in the assessed knowledge, and an overall average score of 7.56 (initially 5.20 out of 10) was obtained. There are also significant increases in habits such as: practicing a first breakfast (98.88 %) or even a mid-morning snack (67.98 % of students). There are also significant increases in the grades of EnKid-type food consumed (presence of dairy products, quality cereal, and fruit). If breakfast and mid-morning snack are considered together, a significant increase in average EnKid quality score would be obtained of 1.61 points (maximun of 3) versus 1.38. Conclusions: Educational intervention improved knowledge and healthy eating habits in the participating students.",2020,Educational intervention improved knowledge and healthy eating habits in the participating students.,"['participating students', '258 teaching students with an average age of 21.4 ± 0.7 years voluntarily participated']","['Food/nutrition education', 'Educational intervention']","['grades of EnKid-type food consumed (presence of dairy products, quality cereal, and fruit', 'average EnKid quality score', 'knowledge and healthy eating habits']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449492', 'cui_str': 'Type of food'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",258.0,0.0324515,Educational intervention improved knowledge and healthy eating habits in the participating students.,"[{'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'Rodrigo Vera', 'Affiliation': 'Facultad de Educación. Universidad Complutense de Madrid.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Ejeda Manzanera', 'Affiliation': 'Facultad de Educación. Universidad Complutense de Madrid.'}]",Nutricion hospitalaria,['10.20960/nh.02912']
2581,32822325,The potential role of organic and conventional yoghurt consumption in the treatment of non-alcoholic fatty liver disease,"INTRODUCTION


Health is an important motivation for the consumption of both organic and functional foods. Organic food contains fewer pesticide residues and statistically more selected health-related compounds such as polyphenols in plant products and polyunsaturated fatty acids in milk and meat products. Recent studies suggest that the gut-liver axis plays an important role in the pathogenesis of non-alcoholic fatty liver disease, so probiotics could be a therapeutic tool. Comparing the health effects of yoghurt from organic origin with so-called conventional yoghurt is difficult, because there is no biomarker that would signal the difference with good specificity and sensitivity.
AIM


The aim of this study was to investigate numerous biomarkers to evaluate the difference between yoghurt from conventional and organic origin and their health effects in NAFLD.
PATIENTS AND METHOD


We performed a prospective, cohort study consisting of 37 (age = 51.73 ± 11.82, male = 21, female = 16) patients with NAFLD at the 2nd Department of Internal Medicine of the Semmelweis University, Budapest. Diagnosis of NAFLD was based on ultrasonography and the exclusion of other etiololgy. The patients were examined also with shear wave elastography to evaluate the hepatic fibrosis stage. We divided the patients randomly into two groups. The patients consumed individually daily 300 grams of yoghurt from organic (n = 21) or conventional (n = 16) origin for 8 weeks. We collected 37 routine laboratory data, measured 4 cytokines, 3 markers of the redox-homeostasis and 14 body composition values before, after, and 12 weeks after the yoghurt consumption.
RESULTS


We found a mild elevation of vitamin D and a minimal reduction of LDL after the yoghurt consumption, but in the other 35 routine laboratory data there was no statistical difference. Adiponectin and leptin levels were elevated after the yoghurt consumption in the ""conventional group"". In contrast, we found significant decrease of adiponectin levels in the ""organic group"" after the treatment. Only the adiponectin tendency was different in the two groups. The induced free radical content was also statistically lower after the yoghurt consumption. In the body composition measurements, there were no significant differences.
CONCLUSION


These data suggest that adiponectin could be a possible biomarker to evaluate the effectiveness of probiotic treatment in non-alcoholic fatty liver disease. Our work can serve as a basis for future studies investigating relationships between organic yoghurt consumption and health outcomes. Orv Hetil. 2020; 161(35): 1466-1474.",2020,"Adiponectin and leptin levels were elevated after the yoghurt consumption in the ""conventional group"".","['37 (age = 51.73 ± 11.82, male = 21, female = 16) patients with NAFLD at the 2nd Department of Internal Medicine of the Semmelweis University, Budapest', '2020; 161(35): 1466-1474']",['adiponectin'],"['adiponectin levels', 'Adiponectin and leptin levels', 'free radical content', 'adiponectin tendency', 'mild elevation of vitamin D']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",37.0,0.0222894,"Adiponectin and leptin levels were elevated after the yoghurt consumption in the ""conventional group"".","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Egresi', 'Affiliation': 'Általános Orvostudományi Kar, Belgyógyászati és Hematológiai Klinika,Semmelweis Egyetem, Budapest, Szentkirályi u. 46., 1088.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Drexler', 'Affiliation': 'Ökológiai és Mezőgazdasági Kutatóintézet, Budapest.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Hagymási', 'Affiliation': 'Általános Orvostudományi Kar, Belgyógyászati és Hematológiai Klinika,Semmelweis Egyetem, Budapest, Szentkirályi u. 46., 1088.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Blázovics', 'Affiliation': 'Gyógyszerésztudományi Kar, Farmakognóziai Intézet,Semmelweis Egyetem, Budapest.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Jakab', 'Affiliation': 'Általános Orvostudományi Kar, Belgyógyászati és Hematológiai Klinika,Semmelweis Egyetem, Budapest, Szentkirályi u. 46., 1088.'}, {'ForeName': 'Ibolya', 'Initials': 'I', 'LastName': 'Kocsis', 'Affiliation': 'Központi Laboratórium,Semmelweis Egyetem, Budapest.'}, {'ForeName': 'Sarolta', 'Initials': 'S', 'LastName': 'Dakó', 'Affiliation': 'Általános Orvostudományi Kar, Belgyógyászati és Hematológiai Klinika,Semmelweis Egyetem, Budapest, Szentkirályi u. 46., 1088.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bacsárdi', 'Affiliation': 'Általános Orvostudományi Kar, Belgyógyászati és Hematológiai Klinika,Semmelweis Egyetem, Budapest, Szentkirályi u. 46., 1088.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Lengyel', 'Affiliation': 'Általános Orvostudományi Kar, Belgyógyászati és Hematológiai Klinika,Semmelweis Egyetem, Budapest, Szentkirályi u. 46., 1088.'}]",Orvosi hetilap,['10.1556/650.2020.31839']
2582,31206501,Plasma Neutrophil Gelatinase-Associated Lipocalin Is Associated With Acute Kidney Injury and Clinical Outcomes in Neonates Undergoing Cardiopulmonary Bypass.,"OBJECTIVES


Acute kidney injury is a frequent complication following neonatal cardiac surgery and is associated with significant morbidity and mortality. The objectives of this study were to determine if plasma neutrophil gelatinase-associated lipocalin levels were associated with acute kidney injury and clinical outcomes in neonates with congenital heart disease undergoing cardiopulmonary bypass.
DESIGN


Retrospective single-center observational study.
SETTING


A pediatric cardiac ICU within a tertiary-care academic hospital.
PATIENTS


Patients age less than 30 days undergoing cardiac surgery requiring cardiopulmonary bypass.
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


Plasma neutrophil gelatinase-associated lipocalin peaked at 12 hours postcardiopulmonary bypass and more than doubled compared with preoperative levels. Higher preoperative and 24-hour postoperative neutrophil gelatinase-associated lipocalin levels were associated with acute kidney injury (r = 0.30, r = 0.49), longer duration of mechanical ventilation (r = 0.40, r = 0.51), ICU (r = 0.32, r = 0.33) and hospital lengths of stay (r = 0.28, r = 0.32), and total hospital charges (r = 0.35, r = 0.30; all p values < 0.05).
CONCLUSIONS


Both preoperative and 24-hour postoperative plasma neutrophil gelatinase-associated lipocalin levels are associated with acute kidney injury and worse clinical outcomes in neonates undergoing cardiac surgery. Plasma neutrophil gelatinase-associated lipocalin levels may have a role in risk stratification for predicting postoperative renal dysfunction as well as providing a potential clinical trajectory in the postoperative period.",2019,Both preoperative and 24-hour postoperative plasma neutrophil gelatinase-associated lipocalin levels are associated with acute kidney injury and worse clinical outcomes in neonates undergoing cardiac surgery.,"['neonates undergoing cardiac surgery', 'neonates with congenital heart disease undergoing cardiopulmonary bypass', 'Neonates Undergoing Cardiopulmonary Bypass', 'Patients age less than 30 days undergoing cardiac surgery requiring cardiopulmonary bypass', 'A pediatric cardiac ICU within a tertiary-care academic hospital']",[],"['Higher preoperative and 24-hour postoperative neutrophil gelatinase-associated lipocalin levels', 'Plasma neutrophil gelatinase-associated lipocalin', 'hospital lengths of stay', 'ICU', 'longer duration of mechanical ventilation', 'total hospital charges']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206175', 'cui_str': 'Charge, Hospital'}]",,0.0890273,Both preoperative and 24-hour postoperative plasma neutrophil gelatinase-associated lipocalin levels are associated with acute kidney injury and worse clinical outcomes in neonates undergoing cardiac surgery.,"[{'ForeName': 'Luke W', 'Initials': 'LW', 'LastName': 'Schroeder', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Buckley', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Stroud', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Renee H', 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Nadeau', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Barrs', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002035']
2583,31310895,Spotting Dalmatians: Children's ability to discover subordinate-level word meanings cross-situationally.,"Even when children encounter a novel word in the situation of a clear and unique referent, they are nevertheless faced with the problem of semantic uncertainty: when ""puziv"" refers to a co-present spotted dog, does the word mean Fido, Dalmatian, dog, animal, or entity? Here we explored the extent to which children (3-5 years of age) can reason about a novel word's meaning from information they have gathered cross-situationally, from a series of simple ostensive labeling events (""I see a puziv!""). Of particular interest were the conditions under which children arrive at a subordinate level meaning (e.g., Dalmatian) rather than a basic level meaning (e.g., dog). Experiment 1 showed that children (N = 32) were capable of using lexical contrast and/or mutual exclusivity cross-situationally, such that they arrived at subordinate level meanings only when the words being learned contrasted at the subordinate level, otherwise they strongly preferred basic level meanings (e.g., dog) even when the word had previously referred to subordinate level exemplars (always Dalmatians). Experiment 2 showed that some children in this same age range (N = 20) can also arrive at subordinate level meanings cross-situationally when offered relatively minimal linguistic support (""It's a kind of dog.""). The findings are interpreted with respect to current theories of cross-situational word learning, and suggest that word meanings rather than sets of referential exemplars are tracked and used for cross-situational comparison.",2019,"Experiment 1 showed that children (N = 32) were capable of using lexical contrast and/or mutual exclusivity cross-situationally, such that they arrived at subordinate level meanings only when the words being learned contrasted at the subordinate level, otherwise they strongly preferred basic level meanings (e.g., dog) even when the word had previously referred to subordinate level exemplars (always Dalmatians).",['children (3-5\u202fyears of age'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],[],32.0,0.0178649,"Experiment 1 showed that children (N = 32) were capable of using lexical contrast and/or mutual exclusivity cross-situationally, such that they arrived at subordinate level meanings only when the words being learned contrasted at the subordinate level, otherwise they strongly preferred basic level meanings (e.g., dog) even when the word had previously referred to subordinate level exemplars (always Dalmatians).","[{'ForeName': 'Felix Hao', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': 'University of Nevada, Las Vegas, United States. Electronic address: hao.wang@unlv.edu.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Trueswell', 'Affiliation': 'University of Pennsylvania, United States. Electronic address: trueswel@psych.upenn.edu.'}]",Cognitive psychology,['10.1016/j.cogpsych.2019.101226']
2584,32851636,Caffeine Supplementation or Carbohydrate Mouth Rinse Improves Performance.,"Training volume is one of the critical variables required to promote resistance training benefits (e. g., hypertrophy, muscular strength). Thus, strategies to improve training volume are required. We tested the hypothesis that there is an increase in performance and reduction in the rate of perceived exertion in strength training with caffeine supplementation, carbohydrate mouth rinse, and a synergistic effect of caffeine supplementation plus carbohydrate mouth rinse. We recruited 29 physically active women: 24±4 years, 60.0±7.9 kg, 161.0±6.0 cm. This study was a double-blind, randomized, placebo-controlled, and crossover one. The subjects performed all sessions of strength training under different conditions: caffeine (6.5 mg·kg -1  body mass); carbohydrate (6 g of maltodextrin rinsed for 10 s); caffeine plus carbohydrate; or placebo. We applied the ANOVA for repeated measures through the null-hypothesis statistical test, and the Bayes factors analyses approach. The subjects showed significant improvement in the total repetitions (P<0.01; BF 10  ~99%) for both lower and upper limb exercises in all conditions compared to placebo without difference among interventions. The rate of perceived exertion (P>0.05) did not differ among interventions. However, BF 10  analyses showed a higher probability of lower RPE for CAF intervention. We conclude that either caffeine supplementation or carbohydrate mouth rinse can improve performance in resistance training. There is no additional effect of caffeine plus carbohydrate.",2020,The subjects showed significant improvement in the total repetitions (P<0.01; BF 10  ~99,"['29 physically active women: 24±4 years, 60.0±7.9\u2009kg, 161.0±6.0\u2009cm']","['Caffeine Supplementation or Carbohydrate Mouth Rinse', 'placebo', 'caffeine supplementation or carbohydrate mouth rinse', 'strength training under different conditions: caffeine (6.5\u2009mg·kg -1  body mass); carbohydrate (6\u2009g of maltodextrin rinsed for 10\u2009s); caffeine plus carbohydrate; or placebo']","['upper limb exercises', 'Performance', 'total repetitions', 'rate of perceived exertion']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",29.0,0.100777,The subjects showed significant improvement in the total repetitions (P<0.01; BF 10  ~99,"[{'ForeName': 'Paulo Eduardo Assis', 'Initials': 'PEA', 'LastName': 'Pereira', 'Affiliation': 'Human Movement Sciences and Rehabilitation, Federal University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Azevedo', 'Affiliation': 'Human Movement Sciences and Rehabilitation, Federal University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Azevedo', 'Affiliation': 'Physical Education, Universitary Foundation of Itaperuna, Itaperuna, Brazil.'}, {'ForeName': 'Warleyson', 'Initials': 'W', 'LastName': 'Azevedo', 'Affiliation': 'Physical Education, Universitary Foundation of Itaperuna, Itaperuna, Brazil.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Physiology and Biokinetic, UNIG Campus V at Itaperuna, Itaperuna, Brazil.'}]",International journal of sports medicine,['10.1055/a-1212-0742']
2585,32851644,"The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response.","OBJECTIVE


To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial.
METHODS


Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes.
RESULTS


The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo.
CONCLUSIONS


The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).",2020,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","['Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days', 'Patients']","['placebo', 'Migraine Prevention', 'erenumab 70\xa0mg (n\xa0=\xa0312), erenumab 140\xa0mg (n\xa0=\xa0318), or placebo']","['mean MMD and MSMD', 'disability', 'changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes', 'MMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.137358,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': 'Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jo H', 'Initials': 'JH', 'LastName': 'Bonner', 'Affiliation': 'Mercy Clinic Neurology and Headache Centre, Saint Louis, MO, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Hallström', 'Affiliation': 'Neuro Center, St Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lenz', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Headache,['10.1111/head.13929']
2586,32851713,Percutaneous nephrostomy versus JJ ureteric stent as the initial drainage method in kidney stone patients presenting with acute kidney injury: A prospective randomized study.,"OBJECTIVE


To compare percutaneous nephrostomy tube versus JJ stent as an initial urinary drainage procedure in kidney stone patients presenting with acute kidney injury.
METHODS


Between January 2017 and January 2019, 143 patients with acute kidney injury secondary to obstructive kidney stone were prospectively randomized into the percutaneous nephrostomy tube group (71 patients) and JJ stent group (72 patients) at Beni-Suef University Hospital, Beni-Suef, Egypt. Exclusion criteria included candidates for acute dialysis, fever (>38°C), pyonephrosis, pregnancy and uncontrolled coagulopathy. The period required for serum creatinine normalization, failure of insertion, operative and fluoroscopy time were recorded. Definitive stone management for proximal ureteral stones >1.5 cm consisted of percutaneous nephrolithotomy for the percutaneous nephrostomy group and ureteroscopic laser lithotripsy for the JJ stent group. For stone size <1.5 cm, ureteroscopy or shockwave lithotripsy was carried out for both groups. Percutaneous nephrolithotomy was carried out for renal stones >2 cm, and shockwave lithotripsy for stones <2 cm. Distal and mid ureteral stones were treated by ureteroscopy.
RESULTS


The percutaneous nephrostomy group had shorter operative time (P = 0.001). There was no significant difference in the recovery period for normalization of serum creatinine between both groups (P = 0.120). Procedural failure, ureteric mucosal injury and perforations increased in the case of male sex, stone size >1.5 cm and upper ureteric stones in the JJ stent group. Procedural failure, pelvic perforations and intraoperative bleeding increased in case of male sex, mild hydronephrosis and stone size >2.5 cm in the percutaneous nephrostomy group. Suprapubic pain, urethral pain and lower urinary tract symptoms were significant in the JJ stent group. The presence of a JJ stent directed us toward ureteroscopy (P = 0.002) and the presence of a percutaneous nephrostomy directed us toward percutaneous nephrolithotomy (P = 0.001).
CONCLUSIONS


Percutaneous nephrostomy facilitates subsequent percutaneous nephrolithotomy, especially when carried out by a urologist, and it has a higher insertion success rate, a shorter operative time and a lesser incidence of postoperative urinary tract infection than a JJ stent. A JJ stent facilitates subsequent ureteroscopy, but operative complications can increase in the case of proximal ureteral stones >1.5 cm.",2020,"Procedural failure, pelvic perforations and intraoperative bleeding increased in case of male sex, mild hydronephrosis and stone size >2.5 cm in the percutaneous nephrostomy group.","['Between January 2017 and January 2019, 143 patients with acute kidney injury secondary to obstructive kidney stone', 'Exclusion criteria included candidates for acute dialysis, fever (>38°C), pyonephrosis, pregnancy and uncontrolled coagulopathy', 'kidney stone patients presenting with acute kidney injury', 'group (72 patients) at Beni-Suef University Hospital, Beni-Suef, Egypt']","['percutaneous nephrostomy', 'percutaneous nephrostomy group and ureteroscopic laser lithotripsy', 'Percutaneous nephrolithotomy', 'Percutaneous nephrostomy versus JJ ureteric stent', 'shockwave lithotripsy', 'percutaneous nephrolithotomy', 'percutaneous nephrostomy tube group', 'ureteroscopy or shockwave lithotripsy', 'JJ stent', 'percutaneous nephrostomy tube versus JJ stent', 'Definitive stone management']","['serum creatinine normalization, failure of insertion, operative and fluoroscopy time', 'Procedural failure, pelvic perforations and intraoperative bleeding', 'shorter operative time', 'Procedural failure, ureteric mucosal injury and perforations increased in the case of male sex, stone size >1.5\xa0cm and upper ureteric stones', 'Suprapubic pain, urethral pain and lower urinary tract symptoms', 'recovery period for normalization of serum creatinine']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0034216', 'cui_str': 'Pyonephrosis'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0027724', 'cui_str': 'Percutaneous insertion of nephrostomy tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4728074', 'cui_str': 'Procedural failure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0241310', 'cui_str': 'Suprapubic pain'}, {'cui': 'C0151830', 'cui_str': 'Pain in urethra'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]",143.0,0.0326312,"Procedural failure, pelvic perforations and intraoperative bleeding increased in case of male sex, mild hydronephrosis and stone size >2.5 cm in the percutaneous nephrostomy group.","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elbatanouny', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Ragheb', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abdelbary', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Fathy', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Massoud', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abd El Latif', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ayman S', 'Initials': 'AS', 'LastName': 'Moussa', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Rabie M', 'Initials': 'RM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14331']
2587,32851714,Serial cervical length measurements after the 1 st  episode of threatened preterm labor improve prediction of spontaneous delivery prior to 37 weeks' gestation.,"OBJECTIVE


To assess whether repeated cervical length measurements in women discharged from the hospital after their first episode of threatened preterm labor can predict their risk of spontaneous preterm birth METHODS: This is a secondary analysis of a randomized controlled trial on maintenance tocolysis, in which cervical length was measured transvaginally at the time of hospital discharge and respectively after 2, 4, 8 and 12 weeks among women who remained undelivered after their first episode of threatened preterm labor. After univariate analysis, multivariate logistic regression was used to assess if cervical length < 10 mm at the time of hospital discharge or at any follow up evaluation could predict delivery prior to 37 weeks.
RESULTS


57 out of 226 women (25.2%) discharged with the diagnosis of threatened preterm labor delivered prior to 37 weeks. The risk of spontaneous preterm birth was higher among women with CL < 10 mm compared to those with longer CL at hospital discharge (adjusted OR 3.3; 95%CI 1.2 - 9.2). Moreover, preterm delivery was also more common when CL < 10 was detected up to 2 weeks (adjusted OR 2.9; 95%CI 1.1-7.3) or up to 4 weeks (adjusted OR 7.3; 95%CI 2.3-22.8) post discharge.
CONCLUSIONS


women undelivered after their 1 st  episode of threatened preterm labor remain at high risk of spontaneous preterm birth if their CL drops below 10 mm at the time of hospital discharge or at any follow up visit up to 4 weeks later. CL measurement could be included in the antenatal care of these women, to stratify their risk of preterm birth, and to help clinicians improve pregnancy outcome. This article is protected by copyright. All rights reserved.",2020,The risk of spontaneous preterm birth was higher among women with CL < 10 mm compared to those with longer CL at hospital discharge (adjusted OR 3.3; 95%CI 1.2 - 9.2).,"['57 out of 226 women (25.2%) discharged with the diagnosis of threatened preterm labor delivered prior to 37\u2009weeks', 'women discharged from the hospital after their first episode of threatened preterm labor', 'women who remained undelivered after their first episode of threatened preterm labor']",[],"['risk of spontaneous preterm birth', 'Serial cervical length measurements']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439615', 'cui_str': 'First episode'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C1956055', 'cui_str': 'Cervical Length Measurement'}]",226.0,0.401614,The risk of spontaneous preterm birth was higher among women with CL < 10 mm compared to those with longer CL at hospital discharge (adjusted OR 3.3; 95%CI 1.2 - 9.2).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chiossi', 'Affiliation': 'Division of Obstetrics, Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Division of Obstetrics, Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vergani', 'Affiliation': 'Department of Medicine and Surgery, Obstetrics and Gynecology Branch, University of Milano-Bicocca Health Science, IRCCS Policlinico Hospital, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Tommaso', 'Affiliation': 'Health Science Department, Obstetrics and Gynecology Branch, University of Florence, Florence, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Marozio', 'Affiliation': 'Department of Surgical Sciences, Gynecology and Obstetrics 1, University of Turin, Turin, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Acaia', 'Affiliation': 'Department of Medicine and Surgery, Obstetrics and Gynecology Branch, University of Milano-Bicocca Health Science, IRCCS Policlinico Hospital, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pignatti', 'Affiliation': 'Division of Obstetrics, Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Locatelli', 'Affiliation': 'Department of Medicine and Surgery, Obstetrics and Gynecology Branch, University of Milano-Bicocca Health Science, IRCCS Policlinico Hospital, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spitaleri', 'Affiliation': 'Health Science Department, Obstetrics and Gynecology Branch, University of Florence, Florence, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Department of Surgical Sciences, Gynecology and Obstetrics 1, University of Turin, Turin, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zaina', 'Affiliation': 'Department of Medicine and Surgery, Obstetrics and Gynecology Branch, University of Milano-Bicocca Health Science, IRCCS Policlinico Hospital, Milan, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Statistics Unit, Department of Diagnostic and Clinical Medicine and Public Health, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.22188']
2588,32851896,Can biofeedback-based training alleviate fatigue and vigilance performance in fatigued MS patients?,"MS related fatigue might be related to autonomous nervous system (ANS) dysfunctions or to inflammation related vagal (hyper-) activation. Consequently, influencing ANS status may lead to relieve of fatigue. We used two opposite biofeedback interventions to either increase sympathetic (""self-alert training"", SAT) or parasympathetic activation (""progressive muscle relaxation"", PMR). We recorded fatigue status of patients before and after a challenging vigilance task, their behavioural performance on this task, their skin conductance response (SCR), and parameters indicating parasympathetic activity concerning heart rate variability (HRV). We repeated these recordings after the biofeedback training sessions. Patients of the SAT group were able to learn to increase their SCR voluntarily. Patients of the PMR group showed increasing parameters indicating parasympathetic modulation of the HRV. The vigilance task increased their feeling of fatigue. However, there was no effect of biofeedback training on either fatigue status or performance on the vigilance task. Our results show that MS patients can learn to change voluntarily their ANS activity using biofeedback instructions based on SCR and this can be used in future studies to test the postulated link between ANS and fatigue. However, in this experimental intervention we were unable to document a relation between ANS activity and fatigue.  Trial registration:  ClinicalTrials.gov identifier: NCT03268187.",2020,Our results show that MS patients can learn to change voluntarily their ANS activity using biofeedback instructions based on SCR and this can be used in future studies to test the postulated link between ANS and fatigue.,['fatigued MS patients'],"['biofeedback training', 'opposite biofeedback interventions to either increase sympathetic (""self-alert training"", SAT) or parasympathetic activation (""progressive muscle relaxation"", PMR']","['skin conductance response (SCR), and parameters indicating parasympathetic activity concerning heart rate variability (HRV', 'vigilance task increased their feeling of fatigue', 'fatigue status or performance on the vigilance task', 'parasympathetic modulation of the HRV']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0032533', 'cui_str': 'Polymyalgia rheumatica'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",2.0,0.0119744,Our results show that MS patients can learn to change voluntarily their ANS activity using biofeedback instructions based on SCR and this can be used in future studies to test the postulated link between ANS and fatigue.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Sander', 'Affiliation': 'Institute of Psychology, University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Braun', 'Affiliation': 'Department and Polyclinic for Psychiatry and Psychotherapy, Universitätsklinikum Bonn AöR, Bonn, Germany.'}, {'ForeName': 'Fenja', 'Initials': 'F', 'LastName': 'Modes', 'Affiliation': 'Institute of Psychology, University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Schlake', 'Affiliation': 'Median Klinik Wilhelmshaven, Wilhelmshaven, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Eling', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hildebrandt', 'Affiliation': 'Institute of Psychology, University of Oldenburg, Oldenburg, Germany.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1808023']
2589,32851902,The use of 3D ultrasound in comparing surgical techniques for posterior wall prolapse repair: a pilot randomised controlled trial.,"The most appropriate method for repairing posterior vaginal wall prolapse is still debatable. Women with symptomatic prolapse scheduled to undergo surgical repair in the posterior compartment were randomised to standard posterior colporrhaphy (SPC) or fascial and vaginal epithelial plication (FEP). Participants were assessed with the Prolapse Quality of Life (P-QOL) questionnaire, pelvic organ prolapse quantification (POP-Q) examination and three-dimensional ultrasound (3D US) prior to surgery and 6 months postoperatively. The research hypothesis is that 3D US of the pelvic floor is a reliable tool in comparing the anatomical outcomes of the two different surgical techniques. Differences in anatomical outcomes, assessed clinically and by ultrasonographic evaluation, were compared between the two groups using the Independent Mann-Whitney  U -test and the Wilcoxon signed-rank sum test. Twenty-two women were included in the analysis. Six months postoperatively, women in the FEP arm had better anatomical outcomes compared to those who had undergone SPC ( p  = .02). Repeatability of the ultrasound technique was confirmed, showing moderate to very good agreement in all parameters and the 3D US evaluation was corroborated with the clinical examination, showing a greater reduction in the urogenital size in the FEP group. Impact statement  What is already known on this subject?  The low cost and universal availability of the ultrasound (US) makes it the most commonly used diagnostic modality. The ability to see beyond surface anatomy is important and useful in the assessment of the posterior vaginal wall prolapse and the obstructed defaecation, where this method may replace the defaecation proctography (Dietz 2019). Recent advances in pelvic floor ultrasonography (3D US) have achieved repeatability in the measurement of the levator hiatal (LH) dimensions, introducing a valid and readily available tool for researchers and clinicians (Dietz et al. 2005). Ultrasound may distinguish a true rectocele due to the weakening of the rectovaginal fascia from an enterocele, a rectal intussusception, or just a deficient perineum (Guzman Rojas et al. 2016).  What do the results of this study add?  Our study demonstrates that 3D translabial pelvic floor ultrasound is a useful and reliable tool in assessing the anatomical outcome of prolapse surgery.  What are the implications of these findings for clinical practice and/or further research?  Our study demonstrates that 3D translabial ultrasound of the pelvic floor is a useful and reproducible method in evaluating the anatomical outcomes of surgical repair for posterior wall prolapse. Genital hiatus (GH) and levator hiatus (LH) dimensions measured by ultrasound can be used as surrogate anatomical markers in comparing the efficacy of different surgical techniques.",2020,"Repeatability of the ultrasound technique was confirmed, showing moderate to very good agreement in all parameters and the 3D US evaluation was corroborated with the clinical examination, showing a greater reduction in the urogenital size in the FEP group.","['posterior wall prolapse repair', 'Twenty-two women were included in the analysis', 'Women with symptomatic prolapse scheduled to undergo surgical repair in the posterior compartment']","['3D ultrasound', 'standard posterior colporrhaphy (SPC) or fascial and vaginal epithelial plication (FEP']","['Genital hiatus (GH) and levator hiatus (LH) dimensions', 'anatomical outcomes', 'urogenital size', 'Prolapse Quality of Life (P-QOL) questionnaire, pelvic organ prolapse quantification (POP-Q) examination']","[{'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0185026', 'cui_str': 'Plication'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",22.0,0.0440456,"Repeatability of the ultrasound technique was confirmed, showing moderate to very good agreement in all parameters and the 3D US evaluation was corroborated with the clinical examination, showing a greater reduction in the urogenital size in the FEP group.","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Derpapas', 'Affiliation': ""Department of Urogynaecology, St Mary's Hospital, Imperial College Healthcare NHS Trust, Paddington, London, UK.""}, {'ForeName': 'Gopalan', 'Initials': 'G', 'LastName': 'Vijaya', 'Affiliation': ""Department of Urogynaecology, St Mary's Hospital, Imperial College Healthcare NHS Trust, Paddington, London, UK.""}, {'ForeName': 'Kostis', 'Initials': 'K', 'LastName': 'Nikolopoulos', 'Affiliation': 'Department of Urogynaecology, Epsom and St Helier Hospitals NHS Trust, Surrey, Carshalton, UK.'}, {'ForeName': 'Manolis', 'Initials': 'M', 'LastName': 'Nikolopoulos', 'Affiliation': ""Department of Obstetrics and Gynaecology, Queen's Hospital, Romford, Essex, UK.""}, {'ForeName': 'Dudley', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': ""Department of Urogynaecology, King's College Hospital, London, UK.""}, {'ForeName': 'Ruwan', 'Initials': 'R', 'LastName': 'Fernando', 'Affiliation': ""Department of Urogynaecology, St Mary's Hospital, Imperial College Healthcare NHS Trust, Paddington, London, UK.""}, {'ForeName': 'Vik', 'Initials': 'V', 'LastName': 'Khullar', 'Affiliation': ""Department of Urogynaecology, St Mary's Hospital, Imperial College Healthcare NHS Trust, Paddington, London, UK.""}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1786805']
2590,32851921,Continuous Neuromuscular Blockade Following Successful Resuscitation From Cardiac Arrest: A Randomized Trial.,"Background Neuromuscular blockade (NMB) agents are often administered to control shivering during targeted temperature management following cardiac arrest. In this study, we hypothesized that early, continuous NMB would result in a greater reduction in serum lactate levels among comatose patients after cardiac arrest. Methods and Results Randomized trial of continuous NMB for 24 hours versus usual care following cardiac arrest conducted at 5 urban centers in the United States. Adult patients who achieved return of spontaneous circulation, remained unresponsive, and underwent targeted temperature management after cardiac arrest were included. The primary outcome was change in lactate over 24 hours. A total of 83 patients were randomized, and 80 were analyzed (37 and 43 in the NMB and usual care arms, respectively). There was no significant interaction between time and treatment group with respect to change in lactate over 24 hours (median lactate change from 4.2 to 2.0 mmol/L [-2.2 mmol/L] in the NMB arm versus 4.0 to 1.7 mmol/L [-2.3 mmol/L] in the usual care arm; geometric mean difference, 1.3 [95% CI, 1.0-1.8];  P =0.07 for the interaction term). There was no difference in hospital survival (38% [NMB] versus 33% [usual care];  P =0.63) or survival with good functional outcome (30% [NMB] versus 21% [usual care];  P =0.35). There were no adverse events in either arm attributed to study interventions. Conclusions Continuous NMB compared with usual care did not reduce lactate over the first 24 hours after enrollment compared with usual care. There was no difference in overall hospital survival, hospital survival with good neurologic outcome, or adverse events. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02260258.",2020,There was no difference in hospital survival (38% [NMB] versus 33% [usual care];  P =0.63) or survival with good functional outcome (30% [NMB] versus 21% [usual care];  P =0.35).,"['24 hours versus usual care following cardiac arrest conducted at 5 urban centers in the United States', 'A total of 83 patients were randomized, and 80 were analyzed (37 and 43 in the NMB and usual care arms, respectively', 'comatose patients after cardiac arrest', 'Cardiac Arrest', 'Adult patients who achieved return of spontaneous circulation, remained unresponsive, and underwent targeted temperature management after cardiac arrest were included']","['Continuous Neuromuscular Blockade', ' Neuromuscular blockade ', 'continuous NMB']","['change in lactate', 'serum lactate levels', 'adverse events', 'survival with good functional outcome', 'overall hospital survival, hospital survival with good neurologic outcome, or adverse events', 'lactate', 'hospital survival']","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",83.0,0.137074,There was no difference in hospital survival (38% [NMB] versus 33% [usual care];  P =0.63) or survival with good functional outcome (30% [NMB] versus 21% [usual care];  P =0.35).,"[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Division of Pulmonary Critical Care, and Sleep Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Jon C', 'Initials': 'JC', 'LastName': 'Rittenberger', 'Affiliation': 'Department of Emergency Medicine Guthrie Robert Packer Hospital Sayre PA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Swor', 'Affiliation': 'Department of Emergency Medicine Beaumont Hospital, Royal Oak MI.'}, {'ForeName': 'Raghu R', 'Initials': 'RR', 'LastName': 'Seethala', 'Affiliation': ""Department of Emergency Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Kurz', 'Affiliation': 'Department of Emergency Medicine University of Alabama School of Medicine Birmingham AL.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Berg', 'Affiliation': 'Division of Pulmonary Critical Care, and Sleep Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Cocchi', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Mathias J', 'Initials': 'MJ', 'LastName': 'Holmberg', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine University of Pittsburgh PA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Division of Pulmonary Critical Care, and Sleep Medicine Beth Israel Deaconess Medical Center Boston MA.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017171']
2591,32852138,Effect of laying on of hands as a complementary therapy for pain and functioning in older women with knee osteoarthritis: A randomized controlled clinical trial.,"AIM


To assess the effects of laying on of hands (LooH) as a complementary therapy to kinesiotherapy, on pain, joint stiffness, and functional capacity of older women with knee osteoarthritis (KOA) compared to a control group.
METHODS


In this randomized controlled clinical trial, participants were assigned into 3 groups: LooH with a spiritual component (""Spiritist passe"" Group - SPG), LooH without a spiritual component (LooH Group - LHG), and a control group receiving no complementary intervention (Control Group - CG). Patients were assessed at baseline, 8 weeks, and 16 weeks. Primary outcomes were joint stiffness and functional capacity (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), and pain (WOMAC and visual analog scale). Secondary outcomes were anxiety, depression, mobility, and quality of life. Differences between groups were evaluated using an intention-to-treat approach.
RESULTS


A total of 120 women (mean age = 69.2 ± 5.2 years) with KOA were randomized (40 participants per group). At 8 weeks, SPG differed significantly from the LHG for WOMAC Functional Status (between-group difference in the change = 0.97; 95% CI: 0.35 to 1.59, P = .001); Anxiety levels (between-group difference in the change = 1.38; 95% CI: 0.11 to 2.65, P = .027); and also from the CG for all outcomes with exception of WOMAC Stiffness. After 16 weeks, SPG differed significantly from the LHG only for WOMAC Functional Status (between-group difference in the change = 0.92; 95% CI: 0.32 to 1.52, P = .001]) and also from the CG for all outcomes with exception of WOMAC Stiffness and timed up-and-go.
CONCLUSION


Our results suggest that LooH with a ""spiritual component"" may promote better long-term functional outcomes than both LooH without a ""spiritual component"" and a control group without LooH.",2020,"After 16 weeks, SPG differed significantly from the LHG only for WOMAC Functional Status (between-group difference in the change = 0.92; 95% CI: 0.32 to 1.52, P = .001]) and also from the CG for all outcomes with exception of WOMAC Stiffness and timed up-and-go.
","['older women with knee osteoarthritis (KOA', '120 women (mean age\xa0=\xa069.2\xa0±\xa05.2\xa0years) with KOA were randomized (40 participants per group', 'older women with knee osteoarthritis']","['laying', 'LooH with a spiritual component (""Spiritist passe"" Group - SPG), LooH without a spiritual component (LooH Group - LHG), and a control group receiving no complementary intervention (Control Group - CG']","['pain and functioning', 'joint stiffness and functional capacity (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), and pain (WOMAC and visual analog scale', 'Anxiety levels', 'anxiety, depression, mobility, and quality of life', 'WOMAC Functional Status']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0969660', 'cui_str': 'Laying-on-of-Hands'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0075018', 'cui_str': 'spirogermanium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",120.0,0.1237,"After 16 weeks, SPG differed significantly from the LHG only for WOMAC Functional Status (between-group difference in the change = 0.92; 95% CI: 0.32 to 1.52, P = .001]) and also from the CG for all outcomes with exception of WOMAC Stiffness and timed up-and-go.
","[{'ForeName': 'Katy Andrade Monteiro', 'Initials': 'KAM', 'LastName': 'Zacaron', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Cláudia Soares', 'Initials': 'CS', 'LastName': 'Dos Santos', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Cyntia Pace Schmitz', 'Initials': 'CPS', 'LastName': 'Corrêa', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Cotta E Silva', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Isabel Cristina Fonseca', 'Initials': 'ICF', 'LastName': 'Reis', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Maryana', 'Initials': 'M', 'LastName': ""Sant'Ana Simões"", 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Lucchetti', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13952']
2592,32852139,"Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis.","AIM


This study, FKB327-003, is a phase 3, open-label extension (OLE) study comparing the long-term immunogenicity of an adalimumab biosimilar, FKB327 (F), with the reference product (RP).
METHODS


In the OLE, patients completing 24 weeks of an initial randomized, double-blind (DB) study (Period 1) with clinical response and no safety concerns were rerandomized to F or RP, so that two-thirds of patients remained on the same treatment and one-third switched to the alternate treatment for weeks 24 through 54 (OLE weeks 0-30; Period 2), then all received F through week 100 (OLE week 76; Period 3). Treatment sequences were F-F-F (no switch), RP-F-F and RP-RP-F (single switch), and F-RP-F (double switch). Patients who entered the OLE study were evaluated for immunogenicity across switching sequences.
RESULTS


The proportion of patients with positive antidrug antibody (ADA) status at the end of Period 1 was 61.7% and 60.0% for F and RP, respectively. The proportion of patients with positive ADA status did not increase throughout Period 1, and was similar for F and RP at all time points. At the end of Period 3, the proportion of patients with positive ADA status was lower in all treatment sequences, at 51.1%, 54.4%, 48.1%, and 42.5% for F-F-F, F-RP-F, RP-F-F, and RP-RP-F, respectively.
CONCLUSION


The RP and F showed comparable immunogenicity characteristics after long-term administration. Development of ADAs with the RP and F was similar, and was not impacted by switching and double switching between F and RP treatment.",2020,"Development of ADAs with the RP and F was similar, and was not impacted by switching and double switching between F and RP treatment.",['patients with rheumatoid arthritis'],"['adalimumab biosimilar, FKB327', 'adalimumab biosimilar, FKB327 (F), with the reference product (RP']","['Immunogenicity', 'proportion of patients with positive ADA status', 'immunogenicity characteristics', 'proportion of patients with positive antidrug antibody (ADA) status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0450856,"Development of ADAs with the RP and F was similar, and was not impacted by switching and double switching between F and RP treatment.","[{'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Markland', 'Affiliation': 'NDA Group, Leatherhead, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Boyce', 'Affiliation': 'Hammersmith Medicines Research, London, UK.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kawakami', 'Affiliation': 'Fujifilm Kyowa Kirin Biologics, Tokyo, Japan.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Muniz', 'Affiliation': 'Mylan Inc, Canonsburg, PA, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13951']
2593,32852255,The Specific Impact of Nutrition and Physical Activity on Adolescents' Body Composition and Energy Balance.,"Purpose : The aim of the present study was to identify the contribution of nutrition, physical activity (PA), and total energy intake and expenditure on body weight and composition in adolescents.  Methods : Body composition, PA, and dietary intakes from 904 Greek adolescents (446 boys and 458 girls; Age: 14.6 ± 1.5 yrs), were evaluated. All participants were assigned into three groups according to their age-sex adjusted Fat Mass Index: (A) Normal weight (N;  N  = 503), (B) Overweight (OW;  N  = 253), and (C) Obese (O;  N  = 148).  Results : Significant differences were found for body weight and composition, basal metabolic rate (BMR) expressed per kg of body mass (normal weight children exhibited the highest values), physical-total energy expenditure, and energy balances between the groups (η 2 : 0.138 to 0.657;  p  < .05). In contrast, no differences were found for macronutrients' and total energy intakes, food consumption and quality (η 2 : 0.002 to 0.099;  p  > .05) between the three examined groups. Strong, negative correlations were observed between body weight, body fat percentage, PA, and total energy expenditure (r: -0.311 to -0.810;  p  < .001). Lower, negative correlations were found between body weight, body fat percentage, and macronutrients' daily intakes (r:-0.235 to -0.432;  p  < .05). BMR and total energy expenditure had strong, negative relative strengths for the determination of body weight and fat percentage.  Conclusions : In conclusion, it seems that BMR, PA, and total daily energy expenditure expressed per body weight and not the nutritional and total energy intakes, were the primary determinant parameters of body composition and weight in adolescents.",2020,"Significant differences were found for body weight and composition, basal metabolic rate (BMR) expressed per kg of body mass (normal weight children exhibited the highest values), physical-total energy expenditure, and energy balances between the groups (η 2 : 0.138 to 0.657;  p  < .05).","['Overweight (OW;  N  =\xa0253), and (C) Obese (O;  N  =\xa0148', 'adolescents', '904 Greek adolescents (446 boys and 458 girls; Age: 14.6\xa0±\xa01.5\xa0yrs']",['Nutrition and Physical Activity'],"['physical-total energy expenditure, and energy balances', 'BMR, PA, and total daily energy expenditure expressed per body weight and not the nutritional and total energy intakes', ""Adolescents' Body Composition and Energy Balance"", ""body weight, body fat percentage, and macronutrients' daily intakes"", ""macronutrients' and total energy intakes, food consumption and quality"", 'body weight, body fat percentage, PA, and total energy expenditure', 'BMR and total energy expenditure', 'body weight and composition, basal metabolic rate (BMR', 'nutrition, physical activity (PA), and total energy intake and expenditure on body weight and composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",904.0,0.0167473,"Significant differences were found for body weight and composition, basal metabolic rate (BMR) expressed per kg of body mass (normal weight children exhibited the highest values), physical-total energy expenditure, and energy balances between the groups (η 2 : 0.138 to 0.657;  p  < .05).","[{'ForeName': 'Souzana K', 'Initials': 'SK', 'LastName': 'Papadopoulou', 'Affiliation': 'International Hellenic University.'}, {'ForeName': 'Konstantinos G', 'Initials': 'KG', 'LastName': 'Feidantsis', 'Affiliation': 'International Hellenic University.'}, {'ForeName': 'Maria N', 'Initials': 'MN', 'LastName': 'Hassapidou', 'Affiliation': 'International Hellenic University.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Methenitis', 'Affiliation': 'International Hellenic University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1773374']
2594,32852282,Improving Retention in Care and Promoting Adherence to HIV Treatment: Protocol for a Multisite Randomized Controlled Trial of Mobile Phone Text Messaging.,"BACKGROUND


The World Health Organization has prioritized the use of new technologies to assist in health care delivery in resource-limited settings. Findings suggest that the use of SMS on mobile phones is an advantageous application in health care delivery, especially in communities with an increasing use of this device.
OBJECTIVE


The main aim of this trial is to assess whether sending weekly motivational text messages (SMS) through mobile phones versus no text messaging will improve retention in care and promote adherence to treatment and health outcomes among patients receiving HIV treatment in Fako Division of Cameroon.
METHODS


This is a multisite randomized controlled single-blinded trial. Computer-generated random block sizes shall be used to produce a randomization list. Participants shall be randomly allocated into the intervention and control groups determined by serially numbered sealed opaque envelopes. The 156 participants will either receive the mobile phone text message or usual standard of care. We hypothesize that sending weekly motivational SMS reminders will produce a change in behavior to enhance retention; treatment adherence; and, hence, health outcomes. Participants shall be evaluated and data collected at baseline and then at 2, 4, and 6 months after the launch of the intervention. Text messages shall be sent out, and the delivery will be recorded. Primary outcome measures are retention in care and adherence to treatment. Secondary outcomes are clinical (weight, body mass index), biological (virologic suppression, tuberculosis coinfection), quality of life, treatment discontinuation, and mortality. The analysis shall be by intention-to-treat. Analysis of covariates shall be performed to determine factors influencing outcomes.
RESULTS


Recruitment and random allocation are complete; 160 participants were allocated into 3 groups (52 in the single SMS, 55 in the double SMS, and 53 in the control). Data collection and analysis are ongoing, and statistical results will be available by the end of August 2019.
CONCLUSIONS


The interventions will contribute to an improved understanding of which intervention types can be feasible in improving retention in care and promoting adherence to antiretroviral therapy.
TRIAL REGISTRATION


Pan African Clinical Trial Registry in South Africa PACTR201802003035922; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3035.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15680.",2020,"Findings suggest that the use of SMS on mobile phones is an advantageous application in health care delivery, especially in communities with an increasing use of this device.
","['patients receiving HIV treatment in Fako Division of Cameroon', '156 participants will either receive the']","['sending weekly motivational text messages (SMS) through mobile phones versus no text messaging', 'mobile phone text message or usual standard of care']","['clinical (weight, body mass index), biological (virologic suppression, tuberculosis coinfection), quality of life, treatment discontinuation, and mortality', 'retention in care and adherence to treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",160.0,0.223211,"Findings suggest that the use of SMS on mobile phones is an advantageous application in health care delivery, especially in communities with an increasing use of this device.
","[{'ForeName': 'Elvis Asangbeng', 'Initials': 'EA', 'LastName': 'Tanue', 'Affiliation': 'Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Dickson Shey', 'Initials': 'DS', 'LastName': 'Nsagha', 'Affiliation': 'Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Nana Njamen', 'Initials': 'NN', 'LastName': 'Theophile', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Jules Clement Nguedia', 'Initials': 'JCN', 'LastName': 'Assob', 'Affiliation': 'Department of Medical Laboratory Sciences, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}]",JMIR research protocols,['10.2196/15680']
2595,32852294,"Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study.","BACKGROUND


For emergent intrapartum cesarean delivery (CD), the literature does not support the use of any particular local anesthetic solution to extend epidural analgesia to cesarean anesthesia. We hypothesized that 3% chloroprocaine (CP) would be noninferior to a mixture of 2% lidocaine, 150 µg of epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF) in terms of onset time to surgical anesthesia.
METHODS


In this single-center randomized noninferiority trial, adult healthy women undergoing CD were randomly assigned to epidural anesthesia with either CP or LEBF. Sensory blockade (pinprick) to T10 was established before operating room (OR) entry for elective CD. On arrival to the OR, participants received the epidural study medications in a standardized manner to simulate the conversion of ""epidural labor analgesia to surgical anesthesia."" The primary outcome was the time to loss of touch sensation at the T7 level. A noninferiority margin was set at 3 minutes. The secondary outcome was the need for intraoperative analgesia supplementation.
RESULTS


In total, 70 women were enrolled in the study. The mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level was 655 (standard deviation [SD] = 258) seconds for group CP and 558 (269) seconds for group LEBF, a difference in means of 97 seconds (90% confidence interval [CI], SD = -10.6 to 204; P = .10 for noninferiority). The upper limit of the 90% CI for the mean difference exceeded the prespecified 3-minute noninferiority margin. There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
CONCLUSION


Both anesthetic solutions have a rapid onset of anesthesia when used to extend low-dose epidural sensory block to surgical anesthesia. Data from the current study provide insufficient evidence to confirm that CP is noninferior to LEBF for rapid epidural extension anesthesia for CD, and further research is required to determine noninferiority.",2020,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","['70 women were enrolled in the study', 'adult healthy women undergoing CD', 'Epidural Extension Anesthesia in Elective Cesarean Delivery']","['epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF', 'epidural anesthesia with either CP or LEBF', 'LEBF', 'Epinephrine, Sodium Bicarbonate, and Fentanyl', 'Chloroprocaine', 'chloroprocaine (CP', 'Lidocaine', 'lidocaine']","['mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level', 'time to loss of touch sensation at the T7 level', 'intraoperative analgesia', 'need for intraoperative analgesia supplementation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0448760', 'cui_str': 'Dermatome of seventh thoracic nerve'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C0446425', 'cui_str': 'Level of the seventh thoracic vertebra'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",70.0,0.19062,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","[{'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Sharawi', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Prannal', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Horace', 'Initials': 'H', 'LastName': 'Spencer', 'Affiliation': 'Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Mhyre', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005141']
2596,32848915,Internet-Based Cognitive Behavior Therapy Only for the Young? A Secondary Analysis of a Randomized Controlled Trial of Depression Treatment.,"Background


Late-life depression is a major public health concern, driving the development of complementary treatment options. This study investigates the effectiveness and acceptability of internet-based Cognitive Behavioral Therapy (iCBT) in older individuals (60+ years) compared to younger age groups.
Materials and Methods


Secondary analysis of a cluster-randomized controlled trial with 647 (18-82 years; mean 43.9) mild to moderately severe depressed primary care patients receiving either iCBT + treatment as usual (TAU) or TAU alone. Severity of depression was measured by the Beck Depression Inventory (BDI-II) at baseline, 6 weeks and 6 months. Intention-to-treat analysis in three age groups (18-39 years, n = 264; 40-59 years, n = 300; 60+ years, n = 83) was performed, using mixed-effects regression models to quantify treatment effect.
Results


No age differences in the effectiveness of iCBT were found. Patients in the intervention group consistently showed a greater reduction in depression severity than controls in all three age groups and at both follow-ups. Effect sizes ranged from  d  = 0.30 (40-59 years, 6 weeks) to  d  = 1.91 (60+ years, 6 months). Uptake of the intervention was banded around 70% with no differences between age groups ( χ²  = 0.18,  p  = .915). The mean number of completed modules increased with age ( χ²  = 18.99,  p  = .040).
Discussion


iCBT is equally effective in both younger and older individuals, thus providing a valuable complementary element of routine late-life depression care.
Clinical Trial Registration


DRKS-ID: DRKS00005075 https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005075.",2020,Patients in the intervention group consistently showed a greater reduction in depression severity than controls in all three age groups and at both follow-ups.,"['younger and older individuals', 'three age groups (18-39 years, n = 264; 40-59 years, n = 300; 60+ years, n = 83', 'older individuals (60+ years) compared to younger age groups', '647 (18-82 years; mean 43.9) mild to moderately severe depressed primary care patients receiving either']","['Internet-Based Cognitive Behavior Therapy', 'internet-based Cognitive Behavioral Therapy (iCBT', 'iCBT + treatment as usual (TAU) or TAU alone']","['Beck Depression Inventory (BDI-II', 'mean number of completed modules', 'Severity of depression', 'depression severity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",647.0,0.110866,Patients in the intervention group consistently showed a greater reduction in depression severity than controls in all three age groups and at both follow-ups.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Pabst', 'Affiliation': 'Medical Faculty, Institute of Social Medicine, Occupational Health and Public Health (ISAP), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Margrit', 'Initials': 'M', 'LastName': 'Löbner', 'Affiliation': 'Medical Faculty, Institute of Social Medicine, Occupational Health and Public Health (ISAP), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Medical Faculty, Institute of Social Medicine, Occupational Health and Public Health (ISAP), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Luppa', 'Affiliation': 'Medical Faculty, Institute of Social Medicine, Occupational Health and Public Health (ISAP), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Kersting', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Steffi G', 'Initials': 'SG', 'LastName': 'Riedel-Heller', 'Affiliation': 'Medical Faculty, Institute of Social Medicine, Occupational Health and Public Health (ISAP), University of Leipzig, Leipzig, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00735']
2597,32848947,Childhood Maltreatment Alters the Neural Processing of Chemosensory Stress Signals.,"Accumulating evidence suggests that childhood maltreatment (CM) confers risk for psychopathology later in life by inducing hypervigilance to social threat cues such as fearful faces. However, it remains unclear whether the modulatory impact of CM extents to the olfactory domain of social communication in humans. To address this question, we examined whether CM modulates the neural processing of chemosensory threat signals in sweat and whether CM affects the stress-reducing effects of oxytocin (OXT) in this context. In a randomized, double-blind within-subject functional MRI study design, 58 healthy participants (30 females) received intranasal OXT (40 IU) or placebo (PLC) and completed a forced-choice emotion recognition task with faces of varying emotion intensities (neutral to fearful) while exposed to sweat stimuli and a non-social control odor. Axillary sweat samples were collected from 30 healthy male donors undergoing an acute psychosocial stressor (stress) and ergometer training (sport) as control in a pre-study. CM was assessed by the 25-item Childhood Trauma Questionnaire (CTQ). The final fMRI analysis included 50 healthy participants (26 females). Regression analysis showed a stress-specific association of CTQ scores with amygdala hyperreactivity, hippocampal deactivation, and increased functional connectivity between the amygdala and the hippocampus, medial orbitofrontal cortex, and the anterior cingulate cortex (ACC) under PLC. Furthermore, we observed a positive association of CTQ scores and the dampening effects of OXT on stress-related amygdala responses. Our findings suggest that CM may induce hypervigilance to chemosensory threat cues in a healthy sample due to inefficient frontolimbic inhibition of amygdala activation. Future studies should investigate whether increased recruitment of the intralimbic amygdala-hippocampus complex reflects a compensatory mechanism that prevents the development of psychopathology in those who have experienced CM. Furthermore, the results reveal that the stress-specific effects of OXT in the olfactory domain are more pronounced in participants with increasing levels of CM exposure.",2020,"Regression analysis showed a stress-specific association of CTQ scores with amygdala hyperreactivity, hippocampal deactivation, and increased functional connectivity between the amygdala and the hippocampus, medial orbitofrontal cortex, and the anterior cingulate cortex (ACC) under PLC.","['58 healthy participants (30 females', '30 healthy male donors undergoing an', '50 healthy participants (26 females']","['intranasal OXT', 'OXT', 'acute psychosocial stressor (stress) and ergometer training (sport', 'CM', 'placebo (PLC) and completed a forced-choice emotion recognition task with faces of varying emotion intensities (neutral to fearful) while exposed to sweat stimuli and a non-social control odor', 'oxytocin (OXT']","['CTQ scores', 'stress-specific association of CTQ scores with amygdala hyperreactivity, hippocampal deactivation, and increased functional connectivity between the amygdala and the hippocampus, medial orbitofrontal cortex, and the anterior cingulate cortex (ACC', '25-item Childhood Trauma Questionnaire (CTQ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0037405', 'cui_str': 'Social Control'}, {'cui': 'C0028884', 'cui_str': 'With odor'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",58.0,0.111384,"Regression analysis showed a stress-specific association of CTQ scores with amygdala hyperreactivity, hippocampal deactivation, and increased functional connectivity between the amygdala and the hippocampus, medial orbitofrontal cortex, and the anterior cingulate cortex (ACC) under PLC.","[{'ForeName': 'Ayline', 'Initials': 'A', 'LastName': 'Maier', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Heinen-Ludwig', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Güntürkün', 'Affiliation': 'Department of Psychology, Laboratory for Biological Psychology, Ruhr-University of Bochum, Bochum, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry, School of Medicine & Health Sciences, University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00783']
2598,32848956,Editorial: Placebo and Nocebo Effects in Psychiatry and Beyond.,,2020,,[],['Editorial: Placebo'],[],[],"[{'cui': 'C0282412', 'cui_str': 'Editorial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.11984,,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enck', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00801']
2599,32848996,Peer Tutoring Effects on Students' Mathematics Anxiety: A Middle School Experience.,"In this research the effects of reciprocal peer tutoring on students' mathematics anxiety levels were examined. A pretest posttest with control group design was used at a public middle school in Spain. A total of 420 students in 7th, 8th, and 9th grades participated in the study, of which 215 were female and 205 were male. Students were randomly assigned and equally distributed by course grade (140 in each course grade) and experimental condition (210 in the experimental group and 210 in the control group). Quantitative data were gathered using the Mathematics Anxiety Scale developed by Chiu and Henry (1990). Qualitative information was gathered during eight focus group sessions that were held with students. Two main factors were analyzed using the quantitative and qualitative information: mathematics learning anxiety and mathematics evaluation anxiety. Results were analyzed by gender and course grade. Statistically significant improvements were reported for both male and female students in the experimental group and for each course grade for both factors. No statistically significant differences were reported for students in the control group in any case. A moderate effect size was reported for mathematics evaluation anxiety (Hedge's  g  = 0.42), and a large effect size was reported for mathematics learning anxiety (Hedge's  g  = 0.84). Information obtained from the focus groups was consistent with the reported quantitative results. The main conclusion is that peer tutoring may be very beneficial for reducing middle school students' mathematics anxiety, regardless of their gender or grade.",2020,Statistically significant improvements were reported for both male and female students in the experimental group and for each course grade for both factors.,"['A total of 420 students in 7th, 8th, and 9th grades participated in the study, of which 215 were female and 205 were male', ""Students' Mathematics Anxiety""]",['reciprocal peer tutoring'],"['mathematics learning anxiety', 'quantitative and qualitative information: mathematics learning anxiety and mathematics evaluation anxiety', 'mathematics evaluation anxiety', 'Mathematics Anxiety Scale', ""students' mathematics anxiety levels""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",[],"[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.0190774,Statistically significant improvements were reported for both male and female students in the experimental group and for each course grade for both factors.,"[{'ForeName': 'Lidón', 'Initials': 'L', 'LastName': 'Moliner', 'Affiliation': 'Department of Education, Jaume I University, Castellón de la Plana, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alegre', 'Affiliation': 'Department of Didactics of Mathematics, University of Valladolid, Valladolid, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01610']
2600,32849024,Time-Dependent Negative Effects of Verbal and Non-verbal Suggestions in Surgical Patients-A Study on Arm Muscle Strength.,"Introduction


The medical environment is full of suggestions that affect patients and their healing. Most of them inadvertently are negative, thus evoking nocebo effects. Recently, we have reported on the effect of such verbal and non-verbal suggestions as well as alternative formulations on maximal muscular arm strength in healthy volunteers. In the present study, we tested the same suggestions in patients at two time points to evaluate nocebo effects in a clinical situation and the impact of the approaching surgery date.
Methods


In 45 patients, maximal muscular strength during arm abduction was measured by dynamometry of the deltoid muscle group. One test was several days before and the second on the evening before surgery. Baseline values were compared to the performance after exposure to 18 verbal and non-verbal suggestions. The sequence of presumably negative and positive suggestions was randomized for each patient in order to avoid cumulation effects of immediate succession of two negatives. State anxiety was evaluated at both time points, and suggestibility was measured after surgery.
Results


Strong and statistically significant weakening effects were observed with all presumed negative suggestions from daily clinical practice including words of encouragement (91.4% of baseline), evaluation of symptoms (89.0%), announcement of a medical intervention (82.8%), a negative memory (86.5%), expectation of an uncertain future (82.8%), and non-verbal signals (87.7-92.2%). In contrast, alternative formulations did not interfere with muscular performance in most cases. A more pronounced effect was observed in the test repeated closer to the date of surgery, accompanied by a 15% higher anxiety level. The increase in anxiety correlated slightly with stronger weakening effects of suggestions, as did suggestibility.
Conclusions


Negative suggestions cause a decrease in arm muscle strength, i.e., a ""weakening"" of the patient. This effect is enhanced by an increase in anxiety as the time of treatment, like surgery, approaches. The reaction can be avoided by alternative formulations. These nocebo effects that are objectively measured and quantified by a decrease in arm muscle strength are more pronounced in patients, i.e., in a clinical situation, than in healthy volunteers.",2020,"In 45 patients, maximal muscular strength during arm abduction was measured by dynamometry of the deltoid muscle group.",['healthy volunteers'],['Verbal and Non-verbal Suggestions'],"['maximal muscular strength', 'State anxiety', 'negative memory', 'non-verbal signals', 'anxiety level', 'muscular performance', 'anxiety', 'evaluation of symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0557930', 'cui_str': 'Unpleasant memories'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",45.0,0.025192,"In 45 patients, maximal muscular strength during arm abduction was measured by dynamometry of the deltoid muscle group.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zech', 'Affiliation': 'Department of Anesthesiology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schrödinger', 'Affiliation': 'Department of Internal Medicine, District Hospital Wörth an der Donau, Wörth am Rhein, Germany.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Seemann', 'Affiliation': 'Department of Anesthesiology, Agaplesion Diakonieklinikum Hamburg, Hamburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Centre for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Timo F', 'Initials': 'TF', 'LastName': 'Seyfried', 'Affiliation': 'Department of Anesthesiology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ernil', 'Initials': 'E', 'LastName': 'Hansen', 'Affiliation': 'Department of Anesthesiology, University Hospital Regensburg, Regensburg, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01693']
2601,32849284,Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years.,"Background:  Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. However, no effective pharmacological treatment for this condition has been found.  Purpose:  This study evaluated the effect of a nutraceutical containing bioactive components from Bergamot citrus and wild cardoon as a treatment for individuals with fatty liver disease. The primary outcome measure was the change in liver fat content.  Methods:  A total of 102 patients with liver steatosis were enrolled in a double-blind placebo controlled clinical trial. The intervention group received a nutraceutical containing a Bergamot polyphenol fraction and  Cynara Cardunculus  extract, 300 mg/day for 12 weeks. The control group received a placebo daily. Liver fat content, by transient elastography, serum transaminases, lipids and glucose were measured at the baseline and the end of the study.  Results:  We found a greater liver fat content reduction in the participants taking the nutraceutical rather than placebo (-48.2 ± 39 vs. -26.9 ± 43 dB/m,  p  = 0.02); The percentage CAP score reduction was statistically significant in those with android obesity, overweight/obesity as well as in women. However, after adjustment for weight change, the percentage CAP score reduction was statistically significant only in those over 50 years (44 vs. 78% in placebo and nutraceutical, respectively,  p  = 0.007).  Conclusions:  This specific nutraceutical containing bioactive components from Bergamot and wild cardoon reduced the liver fat content during 12 weeks in individuals with liver steatosis over 50 years. If confirmed, this nutraceutical could become the cornerstone treatment of patients affected by liver steatosis.  Clinical Trial Registration:  www.isrctn.com, identifier ISRCTN12833814.",2020,"We found a greater liver fat content reduction in the participants taking the nutraceutical rather than placebo (-48.2 ± 39 vs. -26.9 ± 43 dB/m,  p  = 0.02); The percentage CAP score reduction was statistically significant in those with android obesity, overweight/obesity as well as in women.","['Non-diabetic Individuals Aged Over 50 Years', 'individuals with liver steatosis over 50 years', '102 patients with liver steatosis', 'individuals with fatty liver disease', 'patients affected by liver steatosis']","['nutraceutical containing bioactive components from Bergamot citrus and wild cardoon', 'placebo', 'Bergamot Citrus and Wild Cardoon', 'nutraceutical containing a Bergamot polyphenol fraction and  Cynara Cardunculus  extract', 'placebo daily']","['percentage CAP score reduction', 'liver fat content', 'Liver Steatosis and Body Weight', 'liver fat content reduction', 'Liver fat content, by transient elastography, serum transaminases, lipids and glucose', 'change in liver fat content']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0008865', 'cui_str': 'Citrus'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0997028', 'cui_str': 'Cardoon'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",102.0,0.35442,"We found a greater liver fat content reduction in the participants taking the nutraceutical rather than placebo (-48.2 ± 39 vs. -26.9 ± 43 dB/m,  p  = 0.02); The percentage CAP score reduction was statistically significant in those with android obesity, overweight/obesity as well as in women.","[{'ForeName': 'Yvelise', 'Initials': 'Y', 'LastName': 'Ferro', 'Affiliation': 'Department of Health Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Montalcini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Mazza', 'Affiliation': 'Department of Medical and Surgical Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Foti', 'Affiliation': 'Department of Health Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Angotti', 'Affiliation': 'Department of Clinical and Experimental Medicine, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gliozzi', 'Affiliation': 'Department of Health Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Nucera', 'Affiliation': 'Department of Health Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Paone', 'Affiliation': 'Department of Health Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bombardelli', 'Affiliation': 'Plantexresearch Srl, Milan, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Aversa', 'Affiliation': 'Department of Clinical and Experimental Medicine, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Musolino', 'Affiliation': 'Department of Health Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mollace', 'Affiliation': 'Department of Health Science, University Magna Grecia, Catanzaro, Italy.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Pujia', 'Affiliation': 'Department of Medical and Surgical Science, University Magna Grecia, Catanzaro, Italy.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00494']
2602,32849871,"A Prospective, Randomized, Placebo-Controlled Study of a Combination of Simvastatin and Chemotherapy in Metastatic Breast Cancer.","Preclinical studies support the anticancer activity of statins; however, the existing clinical evidence is inconsistent and not definitive. Our study aimed at evaluating a postulated cancer chemo-sensitizing effect of statin (simvastatin) in a cohort of metastatic breast cancer (MBC) patients. We designed a prospective, single-centered, randomized, double blinded, placebo-controlled trial that encompassed MBC patients with an ECOG Performance Status Scale ≤2 and scheduled to be treated with a chemotherapy regimen consisting of carboplatin and vinorelbine every 3 weeks at Al-Baironi Hospital, Damascus, Syria. Patients were enrolled between August 2011 and July 2012 and randomly allocated to receive a 15-day course of either simvastatin (40 mg) or placebo seven days prior to the first day of each chemotherapy cycle and then continued for eight days in each individual cycle. Primary endpoints were objective response rate (ORR) and toxicity, and the secondary endpoint was overall survival (OS). Eighty-two patients met the inclusion criteria and consented. ORR (35% vs. 32.5%) and predominant toxicity and grade ≥3 neutropenia (occurred in 30% vs. 40% of the patients) were not significantly different between simvastatin and placebo groups, respectively. Over a median follow-up of 44 months (range, 10-60), median OS was 15 months in the simvastatin group and 17 the in placebo group (hazard ratio (HR) = 1.16, 95% CI (0.70-1.91),  P =0.57). Elevated baseline values of high-sensitivity C-reactive protein (hsCRP >10 mg/l), lactate dehydrogenase (LDH >480 U/L), and chemotherapy being ≥2 nd  line were significantly associated with shorter OS for the total cohort in both Univariate and multivariate analyses. Our data prove a safe profile of simvastatin at 40 mg per day combined with carboplatin and vinorelbine in MBC patients but without any beneficial increase of tumor sensitivity to chemotherapy. Moreover, we demonstrated a strong clinical advantage of baseline values of hsCRP and LDH as useful prognostic tools in MBC patients. This trial is registered with ISRCTN12964275.",2020,"ORR (35% vs. 32.5%) and predominant toxicity and grade ≥3 neutropenia (occurred in 30% vs. 40% of the patients) were not significantly different between simvastatin and placebo groups, respectively.","['MBC patients', 'Eighty-two patients met the inclusion criteria and consented', 'metastatic breast cancer (MBC) patients', 'Patients were enrolled between August 2011 and July 2012', 'Metastatic Breast Cancer', 'MBC patients with an ECOG Performance Status Scale ≤2 and scheduled to be treated with a chemotherapy regimen consisting of']","['simvastatin', 'statin (simvastatin', 'placebo', 'Simvastatin and Chemotherapy', 'Placebo', 'carboplatin and vinorelbine']","['predominant toxicity and grade ≥3 neutropenia', 'lactate dehydrogenase', 'ORR', 'objective response rate (ORR) and toxicity, and the secondary endpoint was overall survival (OS', 'median OS']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.427254,"ORR (35% vs. 32.5%) and predominant toxicity and grade ≥3 neutropenia (occurred in 30% vs. 40% of the patients) were not significantly different between simvastatin and placebo groups, respectively.","[{'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Alarfi', 'Affiliation': 'Program of Clinical and Hospital Pharmacy, Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria.'}, {'ForeName': 'Lama A', 'Initials': 'LA', 'LastName': 'Youssef', 'Affiliation': 'Program of Clinical and Hospital Pharmacy, Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Salamoon', 'Affiliation': 'Al-Baironi Hospital, Ministry of Higher Education, Damascus, Syria.'}]",Journal of oncology,['10.1155/2020/4174395']
2603,32850031,"No Difference in Outcome of Anterior Cruciate Ligament Reconstruction with ""Bone-patellar Tendon-bone versus Semitendinosus-gracilis Graft with Preserved Insertion"": A Randomized Clinical Trial.","Background


The type of graft for anterior cruciate ligament (ACL) reconstruction is still a topic of debate and there is still no clear consensus on the ideal graft for ACL reconstruction.
Purpose


This study was conducted to compare the outcome of ACL reconstruction surgery between hamstring tendon graft and bone-patellar tendon-bone (BPTB) graft.
Materials and Methods


One hundred and sixty professional athletes were enrolled in the study. They were divided into two groups by computerized randomization. In Group I, ACL reconstruction was done using BPTB graft, and in Group II, ACL reconstruction was done using semitendinosus gracilis graft with preserved tibial insertion (STGPI). Postoperatively, patients were assessed for knee stability, Lysholm score, and WOMAC score.
Results


Mean KT-1000 side-to-side difference at 1 year was 2.31 ± 1.68 mm in BPTB cohort and 2.52 ± 1.6 mm in STGPI cohort ( P  = 0.4); and at 2 years, it was 1.98 ± 1.62 mm in BPTB cohort and 2.23 ± 1.6 mm in STGPI cohort ( P  = 0.4). Mean Lysholm score at 2 years was 96.1 ± 5.81 in STGPI cohort and 97.3 ± 4.62 in BPTB cohort ( P  = 0.15). Mean WOMAC score at 2 years was 3.3 ± 2.76 in STGPI cohort and 2.84 ± 2.21 in BPTB cohort ( P  = 0.25). Graft rupture rate was 3.75%; 3 patients in each group had graft rupture. Kneeling pain was present in 15% (12/80) of patients with BPTB graft whereas none of the patients in STGPI cohort had kneeling pain.
Conclusion


There was no difference between two grafts in term of knee stability, visual analog scale score and functional outcome. However, hamstring tendon graft is associated with less donor site morbidity.",2020,"There was no difference between two grafts in term of knee stability, visual analog scale score and functional outcome.","['One hundred and sixty professional athletes were enrolled in the study', 'anterior cruciate ligament']","['hamstring tendon graft and bone-patellar tendon-bone (BPTB) graft', 'ACL reconstruction surgery', 'Bone-patellar Tendon-bone versus Semitendinosus-gracilis Graft with Preserved Insertion', 'ACL reconstruction was done using semitendinosus gracilis graft with preserved tibial insertion (STGPI']","['Anterior Cruciate Ligament Reconstruction', 'kneeling pain', 'Kneeling pain', 'Graft rupture rate', 'graft rupture', 'knee stability, visual analog scale score and functional outcome', 'Mean WOMAC score', 'Mean KT-1000 side-to-side difference', 'Mean Lysholm score', 'knee stability, Lysholm score, and WOMAC score']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}]","[{'cui': 'C1279739', 'cui_str': 'Tendon transplantation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0224439', 'cui_str': 'Structure of gracilis muscle'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1260920', 'cui_str': 'Kneeling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1883310', 'cui_str': '1000'}]",160.0,0.0573788,"There was no difference between two grafts in term of knee stability, visual analog scale score and functional outcome.","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Sports Injury Centre and Medical Superintendent, Government Medical College Hospital, Chandigarh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Department of Orthopaedics, Government Medical College Hospital, Chandigarh, India.'}, {'ForeName': 'Ashwani', 'Initials': 'A', 'LastName': 'Soni', 'Affiliation': 'Department of Orthopaedics, Government Medical College Hospital, Chandigarh, India.'}, {'ForeName': 'Sourabh', 'Initials': 'S', 'LastName': 'Khatri', 'Affiliation': 'Department of Orthopaedics, Government Medical College Hospital, Chandigarh, India.'}, {'ForeName': 'Gladson David', 'Initials': 'GD', 'LastName': 'Masih', 'Affiliation': 'Department of Orthopaedics, Government Medical College Hospital, Chandigarh, India.'}, {'ForeName': 'Mukta', 'Initials': 'M', 'LastName': 'Raghav', 'Affiliation': 'Department of Orthopaedics, Government Medical College Hospital, Chandigarh, India.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00073-y']
2604,32850142,Comparison of the Effect of Ranibizumab and Aflibercept on Changes in Macular Choroidal Thickness in Patients Treated for Diabetic Macular Edema.,"Purpose


The aim of this study was to assess the effect of intravitreal injections (IVI) of ranibizumab and aflibercept on the choroidal thickness (CT) in patients with treatment-naive diabetic macular edema (DME) before and after monthly IVI.  Patients and Methods . Prospective monocenter study. Inclusion criteria were treatment-naive DME eyes without concomitant panretinal photocoagulation, associated with a decrease in best-corrected visual acuity ≤75 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. DME was defined by a central retinal thickness ≥300  μ m on swept-source OCT (Triton DRI OCT, Topcon Corporation, Itabashi, Japan). Patients received 5 IVI of ranibizumab or aflibercept. The primary endpoint was the change in the central subfield CT (CSCT) between inclusion (M0) and 1 month after the fifth IVI (M5). The secondary endpoint was the CT changes between M0 and M5 in other locations of the macular ETDRS grid.
Results


Twenty-four eyes of 24 patients with a mean age of 61.1 years were included. Eleven and 13 patients were, respectively, treated with ranibizumab and aflibercept, and 86.4% had type 2 diabetes. The overall CSCT decreased significantly by -12  μ m between M0 and M5 (231.7  μ m at M0 and 219.7  μ m at M5) ( p =0.03). It decreased by -15.2  μ m ( p =0.02) in the aflibercept group (206.9  μ m at M0 and 191.7  μ m at M5) and by -7.3  μ m ( p =0.4) in the ranibizumab group (267.5  μ m at M0 and 260.2  μ m at M5). The CSCT decreased by -4.9  μ m in noninjected contralateral eyes (242.3  μ m at M0 and 237.4  μ m at M5). CT changes between M0 and M5 in the superior, temporal, inferior, and nasal macular inner ring were significant in the aflibercept group but not in the ranibizumab and control groups.
Conclusion


In DME patients, the CSCT decreases after 5 IVI of anti-VEGF, especially after aflibercept treatment.",2020,"CT changes between M0 and M5 in the superior, temporal, inferior, and nasal macular inner ring were significant in the aflibercept group but not in the ranibizumab and control groups.
","['Results\n\n\nTwenty-four eyes of 24 patients with a mean age of 61.1 years were included', 'patients with treatment-naive diabetic macular edema (DME) before and after monthly IVI', ' and 86.4% had type 2 diabetes', 'Patients Treated for Diabetic Macular Edema']","['Ranibizumab and Aflibercept', 'intravitreal injections (IVI) of ranibizumab and aflibercept', 'ranibizumab and aflibercept', 'DME', 'ranibizumab or aflibercept', 'DME eyes without concomitant panretinal photocoagulation', 'ranibizumab']","['CSCT decreases', 'change in the central subfield CT (CSCT', 'Macular Choroidal Thickness', 'CSCT', 'overall CSCT', 'CT changes between M0 and M5', 'choroidal thickness (CT', 'CT changes between M0 and M5 in the superior, temporal, inferior, and nasal macular inner ring']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}]",24.0,0.0330276,"CT changes between M0 and M5 in the superior, temporal, inferior, and nasal macular inner ring were significant in the aflibercept group but not in the ranibizumab and control groups.
","[{'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Sarda', 'Affiliation': 'Ophthalmology Department, Hôpital Avicenne, 125 Rue de Stalingrad, Bobigny 93000, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Eymard', 'Affiliation': 'Ophthalmology Department, Hôpital Avicenne, 125 Rue de Stalingrad, Bobigny 93000, France.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hrarat', 'Affiliation': 'Ophthalmology Department, Hôpital Avicenne, 125 Rue de Stalingrad, Bobigny 93000, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Fajnkuchen', 'Affiliation': 'Ophthalmology Department, Hôpital Avicenne, 125 Rue de Stalingrad, Bobigny 93000, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Giocanti-Aurégan', 'Affiliation': 'Ophthalmology Department, Hôpital Avicenne, 125 Rue de Stalingrad, Bobigny 93000, France.'}]",Journal of ophthalmology,['10.1155/2020/5708354']
2605,32850204,Management of Grade IV Pressure Ulcers With a Novel Negative Pressure Device in Traumatic Paraplegia Subjects.,"Introduction Pressure ulcers (PUs) are a major health problem for bedridden patients or persons with reduced mobility; individuals with spinal cord injury (SCI) are more prone to developing pressure ulcers. The purpose of this study was to determine the efficacy of a novel negative pressure wound therapy (NPWT) system for the treatment of Grade IV PUs. Methods A total of 34 SCI patients with Grade IV PUs were divided into two groups: 17 cases were managed by our bellows-powered negative pressure device (NPD) and 17 received wet-to-moist gauze dressing as standard wound care. Results Wound healing outcome measures were recorded every week (at seven days) and compared at weeks 3, 6, and 9. There were no significant changes in the length and width of PUs between the groups till week 3. Significantly reduced length and width of NPD-treated PUs were found at week 6 (p=0.04) that further reduced at week 9 (p=0.001) as compared to standard wound care. Similarly, significant reduction in the depth of PUs was found in the NPD-treated group at week 9 (p<0.05). Exudate levels were significantly (p=0.001) lower in the NPD-treated group as compared to the standard wound care group from week 3 (2.96±0.21 vs 2.62±0.49); this difference continued through week 9 (1.35±0.75 vs 0.14±0.35). Disappearance of slough and formation of healthy granulation tissue was significantly higher in the NPD-treated PUs after week 6 (p=0.001). Conclusion NPWT may be the future of wound healing. As an alternative to the existing electrically powered NPWT systems, our NPD is safe, easy to apply, and efficacious in treating the PUs.",2020,Significantly reduced length and width of NPD-treated PUs were found at week 6 (p=0.04) that further reduced at week 9 (p=0.001) as compared to standard wound care.,"['34 SCI patients with Grade IV PUs\xa0were divided into two groups: 17 cases were', 'bedridden patients or persons with reduced mobility; individuals with spinal cord injury (SCI', 'Traumatic Paraplegia Subjects']","['novel negative pressure wound therapy (NPWT) system', 'managed by our bellows-powered negative pressure device (NPD) and\xa017 received wet-to-moist gauze dressing as standard wound care']","['length and width of NPD-treated PUs', 'Grade IV Pressure Ulcers', 'Exudate levels', 'Disappearance of slough and formation of healthy granulation tissue', 'length and width of PUs', 'depth of PUs']","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0425251', 'cui_str': 'Bed-ridden'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0476650', 'cui_str': 'Reduced mobility'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C1998495', 'cui_str': 'Gauze dressing'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027544', 'cui_str': 'Necrotic debris'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",34.0,0.0193983,Significantly reduced length and width of NPD-treated PUs were found at week 6 (p=0.04) that further reduced at week 9 (p=0.001) as compared to standard wound care.,"[{'ForeName': 'Mukesh K', 'Initials': 'MK', 'LastName': 'Dwivedi', 'Affiliation': ""Orthopaedic Surgery, King George's Medical University, Lucknow, IND.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bhagat', 'Affiliation': ""Orthopaedic Surgery, King George's Medical University, Lucknow, IND.""}, {'ForeName': 'Rajeshwar N', 'Initials': 'RN', 'LastName': 'Srivastava', 'Affiliation': ""Orthopaedic Surgery, King George's Medical University, Lucknow, IND.""}, {'ForeName': 'Lavini', 'Initials': 'L', 'LastName': 'Raj', 'Affiliation': 'Data Analytics, Hult International Business School, San Francisco, USA.'}]",Cureus,['10.7759/cureus.9327']
2606,32850277,Effect of manual lymph drainage for up to 10 days after total knee arthroplasty: Arandomized controlled trial.,"OBJECTIVE


To assess the effect of manual lymph drainage (MLD) on pain in Japanese patients up to 10 days after a total knee arthroplasty (TKA).
METHODS


This study was a randomized controlled trial performed at a University Medical Center. Patients who underwent unilateral TKA and received once daily MLD for 20 minutes prior to standard physical therapy up to 10 days after TKA were investigated. Pain at rest, knee extension muscle contraction, and maximum load were assessed using the visual analog scale (mm) before surgery, after drain removal, and after the fifth MLD. As secondary outcomes, the circumference, range of motion, muscle strength, walking speed, and walking rate were evaluated.
RESULT


Forty-one patients aged 45-85 participated in this study, 21 of whom were assigned to the intervention (MLD group) and 20 who were not (control group). Ten days after TKA, no significant difference was evident between the MLD and control groups for resting pain [4.5 mm (1.6-10.8) vs 7.0 mm (1.8-25.5), respectively, p=0.17], pain during knee extension muscle contraction [12.3 mm (4.5-24.8) vs 20.8 mm (6.4-31.8), p=0.41], and pain at maximum load [13.0 mm (8.3-39.8) vs 16.0 mm (4.6-32.5), p=0.73]. There were no significant differences between groups in terms of secondary outcomes.
CONCLUSION


This study shows that MLD up to 10 days after TKA does not affect pain.",2020,"Ten days after TKA, no significant difference was evident between the MLD and control groups for resting pain [4.5 mm (1.6-10.8) vs 7.0 mm (1.8-25.5), respectively, p=0.17], pain during knee extension muscle contraction [12.3 mm (4.5-24.8) vs 20.8 mm (6.4-31.8), p=0.41], and pain at maximum load [13.0 mm (8.3-39.8) vs 16.0 mm (4.6-32.5), p=0.73].","['University Medical Center', 'Forty-one patients aged 45-85 participated in this study, 21 of whom were assigned to the intervention (MLD group) and 20 who were not (control group', 'Japanese patients up to 10 days after a total knee arthroplasty (TKA', 'up to 10 days after total knee arthroplasty']","['MLD', 'unilateral TKA', 'manual lymph drainage (MLD', 'manual lymph drainage']","['circumference, range of motion, muscle strength, walking speed, and walking rate', 'resting pain', 'pain during knee extension muscle contraction', 'Pain at rest, knee extension muscle contraction, and maximum load', 'pain']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",41.0,0.242068,"Ten days after TKA, no significant difference was evident between the MLD and control groups for resting pain [4.5 mm (1.6-10.8) vs 7.0 mm (1.8-25.5), respectively, p=0.17], pain during knee extension muscle contraction [12.3 mm (4.5-24.8) vs 20.8 mm (6.4-31.8), p=0.41], and pain at maximum load [13.0 mm (8.3-39.8) vs 16.0 mm (4.6-32.5), p=0.73].","[{'ForeName': 'Tatsu', 'Initials': 'T', 'LastName': 'Fujiura', 'Affiliation': 'Yokohama City University Medical Center.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nagasawa', 'Affiliation': 'Shonan University of Medical Sciences.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': 'Yokohama City University Medical Center.'}]",Physical therapy research,['10.1298/ptr.E9992']
2607,32850296,Grape seed extract alleviates radiation-induced damages in human blood lymphocytes.,"Objective


Ionizing radiation induces deleterious effects in the biological systems by producing free radicals. Grape Seed Extract (GSE) as a free radical scavenger could protect the body against the damages .
Materials and Methods


In this study, 12 healthy male volunteers were divided into Groups 1, 2, 3 and 4 and received 100, 300, 600 and 1000 mg GSE, respectively. Peripheral blood samples were collected from each volunteer 15 min before, and 1, 2, and 5 hr after GSE oral administration. Blood samples were then irradiated with 150 cGy of 100 kvp X-ray (Irradiated control group, was treated with only 1.5 Gy of X-rays). Cytogenic damages were detected by micronucleus assay.
Results


Results showed that irradiation significantly increased the incidence of micronuclei (p<0. 001). In group 1, the mean reduction of micronucleus rate was 26.53%, 34.92%, and 31.38%, 1, 2, and 5 hr after GSE ingestion (p<0.001), respectively; this variable in group 2 was 17.38, 38.33, and 31.38 (p<0. 001), in group 3, was 35.65%, 46%, and 37.15% (p<0.001), respectively and in group 4, was 41.35%, 51.73%, and 50.55% (p<0.0001), respectively. The samples collected 1, 2, and 5 hr after ingestion of GSE exhibited a significant decrease in the incidence of micronuclei compared with the radiation control group. The maximum protection and reduction in frequency of micronuclei (51.73%) was observed 2 hr after ingestion of 1000 mg GSE.
Conclusion


Consumption of GSE before undergoing radiation protects human lymphocytes against X-rays by reducing radiation-induced genotoxicity.",2020,"The maximum protection and reduction in frequency of micronuclei (51.73%) was observed 2 hr after ingestion of 1000 mg GSE.
","['12 healthy male volunteers', 'human blood lymphocytes']","['Grape Seed Extract (GSE', 'Ionizing radiation']","['Cytogenic damages', 'mean reduction of micronucleus rate', 'Peripheral blood samples', 'maximum protection and reduction in frequency of micronuclei', 'incidence of micronuclei']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}]","[{'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C0034538', 'cui_str': 'Ionizing radiation'}]","[{'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026004', 'cui_str': 'Micronucleus'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",12.0,0.0476947,"The maximum protection and reduction in frequency of micronuclei (51.73%) was observed 2 hr after ingestion of 1000 mg GSE.
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghasemnezhad Targhi', 'Affiliation': 'Department of Radiology, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Valiallah', 'Initials': 'V', 'LastName': 'Saba', 'Affiliation': 'Department of Radiology, Faculty of Para medicine, AJA University of Medical Sciences, Tehran, Iran.'}]",Avicenna journal of phytomedicine,[]
2608,32850321,Radiomics Based on CECT in Differentiating Kimura Disease From Lymph Node Metastases in Head and Neck: A Non-Invasive and Reliable Method.,"Background:  Kimura disease may be easily misdiagnosed as malignant tumors such as lymph node metastases based on imaging and clinical symptoms. The aim of this article is to investigate whether the radiomic features and the model based on the features on venous-phase contrast-enhanced CT (CECT) images can distinguish Kimura disease from lymph node metastases in the head and neck.  Methods:  A retrospective analysis of 14 patients of head and neck Kimura disease (a total of 38 enlarged lymph nodes) and 39 patients with head and neck lymph node metastases (a total of 39 enlarged lymph nodes), confirmed by biopsy or surgery resection, was conducted. All patients accepted CECT within 10 days before biopsy or surgery resection. Radiomic features based on venous-phase CECT were generated automatically from Artificial-Intelligence Kit (AK) software. All lymph nodes were randomly divided into the training set ( n  = 54) and testing set ( n  = 23) in a ratio of 7:3. ANOVA + Mann-Whitney, Spearman correlation, least absolute shrinkage and selection operator, and Gradient Descent were introduced for the reduction of the highly redundant features. Binary logistic regression model was constructed based on the selected features. Receiver operating characteristic was used to evaluate the diagnostic performance of the features and the model. Finally, a nomogram was established for model application.  Results : Seven features were screened out at the end. Significant difference was found between the two groups for all the features with area under the curves (AUCs) ranging from 0.759 to 0.915. The AUC of the model's identification performance was 0.970 in the training group and 0.977 in the testing group. The disease discrimination efficiency of the model was better than that of any single feature.  Conclusions : The radiomic features and the model based on these features on venous-phase CECT images had very good performance for the discrimination between Kimura disease and lymph node metastases in the head and neck.",2020,The AUC of the model's identification performance was 0.970 in the training group and 0.977 in the testing group.,"['Differentiating Kimura Disease From Lymph Node Metastases in Head and Neck', '14 patients of head and neck Kimura disease (a total of 38 enlarged lymph nodes) and 39 patients with head and neck lymph node metastases (a total of 39 enlarged lymph nodes), confirmed by biopsy or surgery resection, was conducted', 'All lymph nodes']","['venous-phase contrast-enhanced CT (CECT', 'CECT']",[],"[{'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0033838', 'cui_str': ""Kimura's disease""}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0229863', 'cui_str': 'Structure of lymph nodes of body as a whole'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0026024', 'cui_str': 'Phase contrast microscopy'}]",[],7.0,0.0171547,The AUC of the model's identification performance was 0.970 in the training group and 0.977 in the testing group.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Graduate School, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Shujing', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of CT Diagnosis, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of CT Diagnosis, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Liqing', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Magnetic Resonance Imaging, Cangzhou Central Hospital, Cangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01121']
2609,32850338,Subdivision of IIIC Stage for Endometrioid Carcinoma to Better Predict Prognosis and Treatment Guidance.,"Objective:  The prognostic value of Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) IIIC staging in endometrioid carcinoma patients remains debatable. The current study aimed to compare the prognosis between IIIC1 and IIIC2 patients with endometrioid carcinoma and attempt to conduct a new subdivision.  Methods:  By using the Surveillance, Epidemiology, and End Results (SEER) database, patients with endometrioid-type endometrial cancer diagnosed from 2004 to 2015 were identified and randomly divided into training and validation sets. We developed a Fine-Gray competing risk model to compare the cancer-specific mortality (CSM). The IIIC subdivision system was built based on the independent prognostic factors. The cumulative incidence curves were compared using Gray's test or log-rank test. Nomogram for predicting 3- or 5-years CSM was constructed and subsequently validated internally and externally.  Results:  The IIIC subdivision defined by FIGO staging, including IIIC1 and IIIC2, exhibited no association with CSM in multivariate analysis [subdistribution hazard ratio [SHR] = 1.03, 95% CI [0.85-1.26],  P  = 0.760]. The IIIC category was subdivided into three subcategories based on the tumor (T) and nodes (N) stage, including IIICa (T1N1 and T1N2), IIICb (T2N1 and T2N2), and IIICc (T2N1 and T2N2). The prognosis across new IIIC subcategories with CSM remained significant [IIICb vs. IIICa: SHR = 1.53, 95% CI [1.18-1.98],  P  = 0.001; IIICc vs. IIICa: SHR = 2.64, 95% CI [2.13-3.28],  P  < 0.001]. Postoperative adjuvant chemotherapy or radiotherapy alone did not improve survival for patients categorized as IIICa or IIICb, and all IIIC patients benefited most from combination of postoperative chemotherapy and radiotherapy [IIICa: SHR = 0.59, 95% CI [0.43-0.82],  P  = 0.001; IIICb: SHR = 0.66, 95% CI [0.45-0.97],  P  = 0.036; IIICc: SHR = 0.44, 95% CI [0.34-0.58],  P  < 0.001]. A nomogram based on competing risk model was built to predict the long-term survival of IIIC patients, with a concordance index above 0.70 both in training and validation set.  Conclusion:  There was no prognostic difference between FIGO IIIC1 and IIIC2 patients with endometrioid-type endometrial cancer. A new subdivision of IIIC category facilitates prognosis prediction and treatment modalities. A combination of postoperative chemotherapy and radiotherapy exerted as the optimal choice for endometrioid cancer patients with IIIC stage.",2020,There was no prognostic difference between FIGO IIIC1 and IIIC2 patients with endometrioid-type endometrial cancer.,"['IIIC2 patients with endometrioid carcinoma', 'IIIC2 patients with endometrioid-type endometrial cancer', 'patients with endometrioid-type endometrial cancer diagnosed from 2004 to 2015', 'endometrioid cancer patients with IIIC stage', 'endometrioid carcinoma patients']","['Postoperative adjuvant chemotherapy or radiotherapy', 'postoperative chemotherapy and radiotherapy']","['cancer-specific mortality (CSM', 'IIIC subdivision defined by FIGO staging, including IIIC1 and IIIC2', 'survival', 'cumulative incidence curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206687', 'cui_str': 'Endometrioid carcinoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}, {'cui': 'C1273519', 'cui_str': 'Subdivision of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0978074,There was no prognostic difference between FIGO IIIC1 and IIIC2 patients with endometrioid-type endometrial cancer.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': ""Department of Prenatal Diagnosis and Screening Center, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Yanzhen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Prenatal Diagnosis and Screening Center, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, College of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, College of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': ""Department of Obstetrics, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Zhong', 'Affiliation': 'Department of Breast Surgery, College of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01175']
2610,32850394,Randomized Controlled Study Comparing Efficacy and Toxicity of Weekly vs. 3-Weekly Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma.,"Background:  Head and Neck Cancer is a major public health problem in India, majority of which are lifestyle related, male predominant requiring dedicated infrastructure and human resource. The 5-year survival is 59% for all stages combined and only 45% in patients with locally advanced inoperable head and neck cancer using current chemoradiation schedules. Chemotherapy agents administered in the induction or concurrent setting comprise of taxanes (Docetaxel, paclitaxel), platinum compounds (Cisplatin, carboplatin) and fluorouracil (TPF). For patients with advanced Head and neck squamous cell carcinoma (HNSCC), 3-weekly TPF regimen is the established standard induction chemotherapy (ICT) option based on overall survival benefit. However, TPF regimen is known to be associated with significant dose limiting toxicities which may impair tolerance and effectiveness of therapy. In this study we assessed the efficacy and toxicity of weekly vs. 3-weekly Docetaxel, Cisplatin, and Fluoro-uracil (TPF) induction chemotherapy in locally advanced Head and neck squamous cell carcinoma (LA-HNSCC).  Methods:  This was an open labeled randomized two arm study with 41 patients in the 3-weekly TPF arm and 41 patients in the weekly arm. Patients were randomized using numbers from a randomization software, data recorded, and results were analyzed.  Results:  The weekly group achieved far greater symptom relief than 3-weekly group (72 vs. 64%). The overall response rates were similar in both arms (ORR 75.6 and 73.1% in the weekly and 3-weekly groups, respectively). Renal toxicity was significantly lower in the weekly group as compared to 3 weekly arm post three cycles of chemotherapy (CrCl 91.49 ml/min vs. 76.67 ml/min, respectively). The weekly group had predominantly grade I and II neutropenia (19.5 and 17.1%, respectively) as compared to 3-weekly group where grade III and IV neutropenia (31 and 12%, respectively) was more prominent ( p -0.003). Among non-hematological toxicities, mucositis, nausea/vomiting, and diarrhea in the weekly group were significantly lower when compared to 3-weekly group. Progression free survival was slightly higher in the weekly group (18 months) when compared to 3-weekly group (15 months) which was not statistically significant.  Conclusion:  Weekly induction with TPF had lower toxicity and similar efficacy as compared to 3-weekly regimen in locally advanced HNSCC patients. Myelosuppression, which was the most serious and common complication of 3-weekly TPF regimens was notably low using the weekly regimen. Our results suggest that weekly TPF regimen may be a safer and effective alternative to 3-weekly TPF for treatment of LA-HNSCC. To our knowledge this is the first study reporting the efficacy of weekly TPF regimen in LA-HNSCC till date.",2020,"Renal toxicity was significantly lower in the weekly group as compared to 3 weekly arm post three cycles of chemotherapy (CrCl 91.49 ml/min vs. 76.67 ml/min, respectively).","['locally advanced Head and neck squamous cell carcinoma (LA-HNSCC', '41 patients in the 3-weekly TPF arm and 41 patients in the weekly arm', 'patients with locally advanced inoperable head and neck cancer', 'locally advanced HNSCC patients', 'Locally Advanced Head and Neck Squamous Cell Carcinoma', 'patients with advanced Head and neck squamous cell carcinoma (HNSCC']","['TPF', 'Docetaxel, Cisplatin, and Fluoro-uracil (TPF) induction chemotherapy', 'taxanes (Docetaxel, paclitaxel), platinum compounds (Cisplatin, carboplatin) and fluorouracil (TPF', '3-Weekly Induction Chemotherapy']","['5-year survival', 'grade I and II neutropenia', 'efficacy and toxicity', 'overall response rates', 'Renal toxicity', 'Progression free survival', 'Efficacy and Toxicity', 'Myelosuppression', 'hematological toxicities, mucositis, nausea/vomiting, and diarrhea', 'grade III and IV neutropenia', 'symptom relief', 'toxicity and similar efficacy']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0206135', 'cui_str': 'Platinum Compounds, Inorganic'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",2.0,0.0222099,"Renal toxicity was significantly lower in the weekly group as compared to 3 weekly arm post three cycles of chemotherapy (CrCl 91.49 ml/min vs. 76.67 ml/min, respectively).","[{'ForeName': 'Devale', 'Initials': 'D', 'LastName': 'Tousif', 'Affiliation': 'HealthCare Global Enterprises Ltd (HCG), Bangalore, India.'}, {'ForeName': 'Vinu', 'Initials': 'V', 'LastName': 'Sarathy', 'Affiliation': 'HealthCare Global Enterprises Ltd (HCG), Bangalore, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'HealthCare Global Enterprises Ltd (HCG), Bangalore, India.'}, {'ForeName': 'Radheshyam', 'Initials': 'R', 'LastName': 'Naik', 'Affiliation': 'HealthCare Global Enterprises Ltd (HCG), Bangalore, India.'}]",Frontiers in oncology,['10.3389/fonc.2020.01284']
2611,32850939,"Blueberry and/or Banana Consumption Mitigate Arachidonic, Cytochrome P450 Oxylipin Generation During Recovery From 75-Km Cycling: A Randomized Trial.","Oxylipins are bioactive lipid oxidation products, have vital regulatory roles in numerous physiological processes including inflammation, and can be impacted by diet. This study determined if 2-weeks of blueberry and/or acute banana ingestion influenced generation of n-6 and n-3 PUFA-derived oxylipins during recovery from exercise-induced physiological stress. Cyclists ( n  = 59, 39 ± 2 years of age) were randomized to freeze-dried blueberry or placebo groups, and ingested 26 grams/d (1 cup/d blueberries equivalent) for 2 weeks. Cyclists reported to the lab in an overnight fasted state and engaged in a 75-km cycling time trial (185.5 ± 5.2 min). Cyclists from each group (blueberry, placebo) were further randomized to ingestion of a water-only control or water with a carbohydrate source (Cavendish bananas, 0.2 g/kg carbohydrate every 15 min) during exercise. Blood samples were collected pre- and post-2-weeks blueberry supplementation, and 0, 1.5, 3, 5, 24, and 48 h-post-exercise. Plasma oxylipins and blueberry and banana metabolites were measured with UPLC-tandem MS/MS. Significant time by treatment effects (eight time points, four groups) were found for 24 blueberry- and seven banana-derived phenolic metabolites in plasma (FDR adjusted  p  < 0.05). Significant post-exercise increases were observed for 64 of 67 identified plasma oxylipins. When oxylipins were grouped relative to fatty acid substrate [arachidonic acid (ARA), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), α-linolenic acid (ALA), linoleic acid (LA)], and enzyme systems [cytochrome P450 (CYP), lipoxygenase (LOX)], banana and blueberry ingestion were independently associated with significant post-exercise reductions in pro-inflammatory ARA-CYP hydroxy- and dihydroxy-eicosatetraenoic acids (HETEs, DiHETrEs) (treatment effects, FDR adjusted  p  < 0.05). These trial differences were especially apparent within the first 3 h of recovery. In summary, heavy exertion evoked a transient but robust increase in plasma levels of oxylipins in cyclists, with a strong attenuation effect linked to both chronic blueberry and acute banana intake on pro-inflammatory ARA-CYP oxylipins.",2020,"In summary, heavy exertion evoked a transient but robust increase in plasma levels of oxylipins in cyclists, with a strong attenuation effect linked to both chronic blueberry and acute banana intake on pro-inflammatory ARA-CYP oxylipins.","['Cyclists ( n  = 59, 39 ± 2 years of age']","['freeze-dried blueberry or placebo', 'placebo', 'water-only control or water with a carbohydrate source (Cavendish bananas, 0.2 g/kg carbohydrate every 15 min) during exercise', 'Cytochrome P450 Oxylipin Generation']","['fatty acid substrate [arachidonic acid (ARA), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), α-linolenic acid (ALA), linoleic acid (LA', 'plasma levels of oxylipins', 'Plasma oxylipins and blueberry and banana metabolites']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.12995,"In summary, heavy exertion evoked a transient but robust increase in plasma levels of oxylipins in cyclists, with a strong attenuation effect linked to both chronic blueberry and acute banana intake on pro-inflammatory ARA-CYP oxylipins.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Nieman', 'Affiliation': 'Human Performance Laboratory, Appalachian State University, North Carolina Research Campus, Kannapolis, NC, United States.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Gillitt', 'Affiliation': 'David H. Murdock Research Institute, Kannapolis, NC, United States.'}, {'ForeName': 'Guan-Yuan', 'Initials': 'GY', 'LastName': 'Chen', 'Affiliation': 'UNCG Center for Translational Biomedical Research, University of North Carolina at Greensboro, North Carolina Research Campus, Kannapolis, NC, United States.'}, {'ForeName': 'Qibin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'UNCG Center for Translational Biomedical Research, University of North Carolina at Greensboro, North Carolina Research Campus, Kannapolis, NC, United States.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sha', 'Affiliation': 'Bioinformatics Services Division, University of North Carolina at Charlotte, North Carolina Research Campus, Kannapolis, NC, United States.'}, {'ForeName': 'Colin D', 'Initials': 'CD', 'LastName': 'Kay', 'Affiliation': 'Food Bioprocessing and Nutrition Sciences Department, Plants for Human Health Institute, North Carolina State University, North Carolina Research Campus, Kannapolis, NC, United States.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Chandra', 'Affiliation': 'Food Bioprocessing and Nutrition Sciences Department, Plants for Human Health Institute, North Carolina State University, North Carolina Research Campus, Kannapolis, NC, United States.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Kay', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Nutrition Research Institute, Kannapolis, NC, United States.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Lila', 'Affiliation': 'Food Bioprocessing and Nutrition Sciences Department, Plants for Human Health Institute, North Carolina State University, North Carolina Research Campus, Kannapolis, NC, United States.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00121']
2612,32851060,Improving Physical Fitness of Children with Intellectual and Developmental Disabilities through an Adapted Rhythmic Gymnastics Program in China.,"Background


Health-related physical fitness is vital for children with intellectual and developmental disabilities (IDD) to gain healthier lives. The adapted rhythmic gymnastics (ARG) program was designed for children with IDD and is aimed at testing the effects of the exercise program on children's physical fitness.
Methods


Participants were recruited from two special needs schools in Beijing of China. Twenty-two children with IDD were assigned to an ARG experimental group or a traditional control group. The experimental group took part in a 16-week ARG program consisting of three 50 min sessions each week. And children's body composition, aerobic capacity, and musculoskeletal functioning were measured by the Brockport Physical Fitness Test (BPFT) before and after the program.
Results


The between-group analysis revealed great improvements for the experimental group in abdominal strength (curl-up test:  p  = 0.025 < 0.05) and upper limb strength (dumbbell press test:  p  = 0.038 < 0.05). Compared to the pretest, most of the physical fitness parameters improved significantly in the experimental group except BMI, and flexibility of the experimental group children showed a substantial increase.
Conclusions


Most of the physical fitness parameters of children with IDD in the experimental group improved significantly, especially on abdominal strength and upper limb muscle strength when comparing to the control group.",2020,"Compared to the pretest, most of the physical fitness parameters improved significantly in the experimental group except BMI, and flexibility of the experimental group children showed a substantial increase.
","['children with intellectual and developmental disabilities (IDD', 'Children with Intellectual and Developmental Disabilities through an Adapted Rhythmic Gymnastics Program in China', 'children with IDD', ""children's physical fitness"", 'Twenty-two children with IDD', 'Methods\n\n\nParticipants were recruited from two special needs schools in Beijing of China']","['\n\n\nHealth-related physical fitness', 'exercise program', 'adapted rhythmic gymnastics (ARG) program', 'ARG experimental group or a traditional control group']","['abdominal strength', 'abdominal strength and upper limb muscle strength', 'upper limb strength', ""And children's body composition, aerobic capacity, and musculoskeletal functioning""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0557805', 'cui_str': 'Special needs school'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",22.0,0.0140573,"Compared to the pretest, most of the physical fitness parameters improved significantly in the experimental group except BMI, and flexibility of the experimental group children showed a substantial increase.
","[{'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Mengxue', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Department of Psychology, Rutgers University, New Brunswick, NJ, USA.'}, {'ForeName': 'Guanting', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}]",BioMed research international,['10.1155/2020/2345607']
2613,32851094,Renal Effects of Sulodexide in Type 2 Diabetic Patients without Nephrotic Range Proteinuria.,"Background


Glycosaminoglycan plays an important role in the maintenance of glomerular charge selectivity of diabetic nephropathy. Sulodexide, a mixture of naturally occurring glycosaminoglycan polysaccharide components, has shown a nephroprotective effect in an experimental model of diabetic nephropathy. Although sulodexide reduced albuminuria in patients with type 1 and type 2 diabetes, long-term effects in patients with type 2 diabetes with significant proteinuria have not been established.
Objectives


The study was aimed at investigating the effects of sulodexide on proteinuria and renal function in patients with type 2 diabetes and nephropathy.
Methods


Fifty-two patients with proteinuria between 500 and 3000 mg/day received sulodexide 200 mg/day for 12 months, while 56 matched patients with type 2 diabetes constituted the control group. All patients received standard metabolic and blood pressure controls. Primary outcome was evaluated as percentage of reduced proteinuria compared with the control group. Renal function was assessed using estimated glomerular filtration rate (GFR).
Results


Proteinuria significantly increased in the control group [0.9 (IQR 0.3 to 1.78) to 1.16 (IQR 0.44 to 2.23) g/gCr,  P  = 0.001], whereas it remained stable in the sulodexide group [0.66 (IQR 0.23 to 0.67) to 0.67 (IQR 0.17 to 1.51) g/gCr,  P  = 0.108]. At 12 months, proteinuria was higher by 19.4% (IQR 10.3 to 37.6) in the control group while proteinuria was lower by -17.7% (IQR -53.1 to 3.2) in the sulodexide group with a significant difference between groups ( P  = 0.001). Renal function was noted as a change of estimated GFR, and serum creatinine decreased significantly during the study in both groups but did not significantly differ between groups. No significant changes in the blood pressure, fasting plasma glucose, and hemoglobin A1C were reported.
Conclusion


In addition to standard treatment, sulodexide is efficient in maintaining proteinuria in patients with type 2 diabetes with nonnephrotic range proteinuria, but it did not provide an additional benefit concerning renal disease progression.",2020,"At 12 months, proteinuria was higher by 19.4% (IQR 10.3 to 37.6) in the control group while proteinuria was lower by -17.7% (IQR -53.1 to 3.2) in the sulodexide group with a significant difference between groups ( P  = 0.001).","['patients with type 2 diabetes with nonnephrotic range proteinuria', 'Type 2 Diabetic Patients without Nephrotic Range Proteinuria', 'patients with type 2 diabetes and nephropathy']","['standard metabolic and blood pressure controls', 'sulodexide', 'Sulodexide']","['glomerular filtration rate (GFR', 'proteinuria', 'percentage of reduced proteinuria', 'Results\n\n\nProteinuria', 'Renal function', 'blood pressure, fasting plasma glucose, and hemoglobin A1C', 'estimated GFR, and serum creatinine', 'proteinuria and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0445118', 'cui_str': 'Nephrotic range proteinuria'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0061450', 'cui_str': 'sulodexide'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",52.0,0.0222294,"At 12 months, proteinuria was higher by 19.4% (IQR 10.3 to 37.6) in the control group while proteinuria was lower by -17.7% (IQR -53.1 to 3.2) in the sulodexide group with a significant difference between groups ( P  = 0.001).","[{'ForeName': 'Kachonsak', 'Initials': 'K', 'LastName': 'Yongwatana', 'Affiliation': 'Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Ouppatham', 'Initials': 'O', 'LastName': 'Supasyndh', 'Affiliation': 'Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Bancha', 'Initials': 'B', 'LastName': 'Satirapoj', 'Affiliation': 'Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}]",Journal of diabetes research,['10.1155/2020/2984680']
2614,32852574,"A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence-the DULOXING study.","INTRODUCTION AND HYPOTHESIS


The aim of our study was to evaluate the effect of a combination of innovative pelvic floor muscle training (iPFMT) and duloxetine compared with the use of duloxetine alone on women with stress urinary incontinence (SUI) after 12 weeks of treatment.
METHODS


We conducted a parallel multicentre study with randomized intervention in 45 national urological outpatient clinics. Patients with an enrolment ratio of 1:1 were divided into the experimental and control groups. The following were used for evaluation: incontinence episode frequency (IEF)/week, the International Consultation on Incontinence Questionnaire (ICIQ-SF), the Urinary Incontinence Quality of Life Scale (I-QoL) and the Patient Global Impression of Improvement (PGI-I). The experimental group received oral treatment with duloxetine (a daily dose of 40 mg BID) and innovative pelvic floor muscle training (iPFMT). The control group received only oral treatment with duloxetine at a daily dose of 40 mg BID.
RESULTS


The number of women who were evaluated was 158. The control group comprised 79 women with an average age of 56.8 ± 13.8 years and the experimental group comprised 79 women with an average age of 53.4 ± 11.9 years. There were no significant differences in pre-treatment parameters. For the intent-to-treat analysis after 12 weeks' treatment, significant differences were observed between the experimental vs. control group (p < 0.001) for the following variables: IEF/week decrease (66.7% vs. 50.0%); ICIQ-UI SF decrease (8.3 ± 3.8 vs. 9.7 ± 4.2); PGI-I (70.8% vs. 65.6%); I-QoL score increase (19.3% vs. 6.6%).
CONCLUSION


The addition of iPFMT to duloxetine treatment improves SUI syndrome in women compared with duloxetine treatment alone.
REGISTRATION


Clinical Trials.gov NCT04140253.",2020,There were no significant differences in pre-treatment parameters.,"['45 national urological outpatient clinics', 'women with stress urinary incontinence (SUI) after 12\xa0weeks of treatment', 'Patients with an enrolment ratio of 1:1', '79 women with an average age of 56.8\u2009±\u200913.8 years and the experimental group comprised 79 women with an average age of 53.4\u2009±\u200911.9 years', 'women with uncomplicated stress urinary incontinence-the DULOXING study']","['innovative pelvic floor muscle training (iPFMT) and duloxetine', 'innovative pelvic floor muscle training (iPFMT', 'duloxetine', 'duloxetine alone', 'duloxetine and innovative pelvic floor muscle training']","['ICIQ-UI SF decrease', 'Incontinence Questionnaire (ICIQ-SF), the Urinary Incontinence Quality of Life Scale (I-QoL) and the Patient Global Impression of Improvement (PGI-I', 'SUI syndrome', 'QoL score increase']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",79.0,0.106008,There were no significant differences in pre-treatment parameters.,"[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Hagovska', 'Affiliation': 'Department of Physiatry, Balneology, and Medical Rehabilitation, Institution-Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Svihra', 'Affiliation': 'Department of Urology, Institution-Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Bratislava, Slovak Republic. jan.svihra@uniba.sk.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Breza', 'Affiliation': 'National Institute of Pediatric Diseases, Department of Pediatric Urology, Faculty of Medicine, Comenius University Bratislava, Bratislava, Slovak Republic.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Dubravicky', 'Affiliation': 'Department of Urology, University Hospital Bratislava, Bratislava, Slovak Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Vargovcak', 'Affiliation': 'Outpatient Clinic of Urology, Railway Hospital, Kosice, Slovak Republic.'}]",International urogynecology journal,['10.1007/s00192-020-04516-w']
2615,32852600,Does patient-specific instrumentation increase the risk of notching in the anterior femoral cortex in total knee arthroplasty? A comparative prospective trial.,"PURPOSE


Patient-specific instrumentation (PSI) was usually applied in total knee arthroplasty (TKA) to acquire a favourable alignment. We hypothesized that using PSI had a potential risk of notching in the anterior femoral cortex, because the femoral component may be placed in an overextension position due to the distal femoral sagittal anteversion. The aim of this study was to figure out the relationship between the notch and the distal femoral sagittal anteversion in PSI-assisted TKA.
METHODS


One hundred thirty-one patients who were to undergo total knee arthroplasty (TKA) were randomly divided into conventional instrumentation (CI) group and PSI group. The computed tomography (CT) data of lower extremities was collected and imported to the Mimics software to reconstruct the three-dimensional (3D) bone image of the femur. The angle between distal femoral anatomic axis (DFAA) and femoral mechanical axis (FMA) on sagittal plane was defined as distal femoral sagittal anteverted angle (DFSAA) and measured. The number of notch intra-operative and post-operative was recorded. Then, we calculated the incidence of the notch and analyzed its relationship with DFSAA.
RESULTS


The average DFSAA of 262 femurs is 2.5° ± 1.5° (range, 0.0°-5.7°). When DFSAA ≥ 3°, the incidence of notch was 7.10% in CI group and 33.30% in PSI group, respectively, which shows significant statistical difference in the two groups (P = 0.016 < 0.05). When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05).
CONCLUSION


DFSAA could be taken as an indicator to predict the notch when performing TKA assisted with PSI. Especially when the DFSAA ≥ 3°, the risk of notch could be markedly increased.",2020,"When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05).
",['One hundred thirty-one patients who were to undergo total knee arthroplasty (TKA'],['conventional instrumentation (CI) group and PSI group'],"['incidence of notch', 'number of notch intra-operative and post-operative', 'distal femoral anatomic axis (DFAA) and femoral mechanical axis (FMA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]",131.0,0.0329578,"When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05).
","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ke', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Tianfei', 'Initials': 'T', 'LastName': 'Ran', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yongqin', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Mingrui', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China. 52solar@sina.cn.'}]",International orthopaedics,['10.1007/s00264-020-04779-4']
2616,32852611,"Impact of naturopathy, yoga, and dietary interventions as adjuvant chemotherapy in the management of stage II and III adenocarcinoma of the colon.","INTRODUCTION


Naturopathy, Yoga and Dietary interventions are known to improve the quality of life in cancer patients. We aim to evaluate the effect of naturopathy interventions along with adjuvant chemotherapy in patients who underwent surgery for Adenocarcinoma of the Colon.
METHODS


A total of 116 adult patients were randomised in to one of the two groups; the experimental group received naturopathy, Yoga and Dietary interventions and the control group received psycho-social counselling in addition to standard chemotherapy. Haematological, biochemical and psychological evaluations were performed at set intervals during a total period of eighteen months starting from the first cycle of adjuvant chemotherapy.
RESULTS


Results showed that the overall hemoglobin (p < 0.0001) and carcinoembryonic antigen (CEA) (p = 0.0038) levels were statistically significant in patients on the experimental arm. The rest of the laboratory parameters, viz. total leukocyte count, platelet counts, and serum creatinine levels, for overall data was not statistically significant in both the groups. Psychological attributes such as anxiety, depression, symptom severity, and Functional Living Index: Cancer (FLIC) were found to be statistically significant (p < 0.0001) in the experimental subjects as compared with those in the control. On the whole, men benefited more than women from the study interventions.
CONCLUSIONS


We conclude that Yoga and Naturopathy interventions in addition to chemotherapy show improvement in overall functional life index along with improvement in haemoglobin in patients with stages II and III Adenocarcinoma of Colon.",2020,"total leukocyte count, platelet counts, and serum creatinine levels, for overall data was not statistically significant in both the groups.","['patients who underwent surgery for Adenocarcinoma of the Colon', 'cancer patients', 'patients with stages II and III Adenocarcinoma of Colon', 'stage II and III adenocarcinoma of the colon', '116 adult patients']","['Yoga and Naturopathy interventions', 'naturopathy, Yoga and Dietary interventions and the control group received psycho-social counselling in addition to standard chemotherapy', 'adjuvant chemotherapy', 'naturopathy, yoga, and dietary interventions', 'naturopathy interventions']","['Haematological, biochemical and psychological evaluations', 'Cancer (FLIC', 'overall functional life index', 'total leukocyte count, platelet counts, and serum creatinine levels', 'overall hemoglobin', 'quality of life', 'Psychological attributes such as anxiety, depression, symptom severity, and Functional Living Index', 'carcinoembryonic antigen (CEA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0338106', 'cui_str': 'Adenocarcinoma of colon'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0027495', 'cui_str': 'Naturopathy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0474156', 'cui_str': 'Social counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}]",116.0,0.0338593,"total leukocyte count, platelet counts, and serum creatinine levels, for overall data was not statistically significant in both the groups.","[{'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Raghunath', 'Affiliation': 'Department of Academics, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India. kalpanaraghunath@induscancer.com.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Sumathi', 'Affiliation': 'Department of Naturopathy and Yoga - Addlife, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'Senthil J', 'Initials': 'SJ', 'LastName': 'Rajappa', 'Affiliation': 'Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'M V T Krishna', 'Initials': 'MVTK', 'LastName': 'Mohan', 'Affiliation': 'Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Department of Naturopathy and Yoga - Addlife, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'Ummar', 'Initials': 'U', 'LastName': 'Shaik', 'Affiliation': 'Indian Institute of Information Technology and Management Kerala, Affiliated to Cochin University, Cochin, India.'}, {'ForeName': 'Mahendran', 'Initials': 'M', 'LastName': 'Botlagunta', 'Affiliation': 'Department of Indo American Cancer Research Foundation, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India. dr_bmnchowdary@induscancer.com.'}]",International journal of colorectal disease,['10.1007/s00384-020-03711-x']
2617,32852619,Evaluation of efficacy of oxygen-enriched oil-based gel dressing in patients who underwent surgical repair of distal hypospadias: a prospective randomised clinical trial.,"PURPOSE


This study aimed to evaluate the efficacy of oxygen-enriched oil-based gel dressing on wound healing and postoperative outcome in children who underwent distal hypospadias repair.
METHODS


We included all patients with distal hypospadias, who underwent Snodgrass urethroplasty and preputioplasty over an 18-months period. The patients were randomized in two groups according to the type of medication: oxygen-enriched oil-based gel (G1) and hyaluronic acid cream (G2). After discharge, parents changed the dressing twice a day for 2-3 weeks postoperatively. The patients were evaluated at 7, 14, 21, 30, 60 and 180 postoperative days and thereafter annually.
RESULTS


One-hundred and fourteen patients (median age 18 months) were included in the study and randomized in two groups, each of 57 patients. The wound healing was significantly faster in G1 compared with G2 (p = 0.001). G1 reported significantly higher SWAS and modified HOPE scores compared with G2 (p = 0.001) at all steps of follow-up. No adverse skin reactions occurred. Foreskin dehiscence and re-operations rates were significantly lower in G1 compared with G2 (p = 0.001). Postoperative foreskin retractability was better in G1, with a significantly higher incidence of secondary phimosis in G2 (p = 0.001). The median treatment costs were significantly lower in G1 compared with G2 (p = 0.001).
CONCLUSION


Postoperative dressing using oxygen-enriched oil-based gel was highly effective, promoting a faster wound healing in patients who underwent distal hypospadias repair. It reported a lower incidence of foreskin dehiscence and better foreskin retractability compared with the control group. It was cost-effective and clinically safe without allergy or intolerance to the product.",2020,G1 reported significantly higher SWAS and modified HOPE scores compared with G2 (p = 0.001) at all steps of follow-up.,"['patients with distal hypospadias, who underwent Snodgrass urethroplasty and preputioplasty over an 18-months period', 'patients who underwent distal hypospadias repair', 'children who underwent distal hypospadias repair', 'patients who underwent surgical repair of distal hypospadias', 'One-hundred and fourteen patients (median age 18\xa0months) were included in the study and randomized in two groups, each of 57 patients']","['oxygen-enriched oil-based gel', 'medication: oxygen-enriched oil-based gel (G1) and hyaluronic acid cream (G2', 'oxygen-enriched oil-based gel dressing']","['Postoperative foreskin retractability', 'wound healing and postoperative outcome', 'adverse skin reactions', 'wound healing', 'cost-effective and clinically safe without allergy or intolerance', 'median treatment costs', 'Foreskin dehiscence and re-operations rates', 'foreskin dehiscence and better foreskin retractability', 'SWAS and modified HOPE scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0558337', 'cui_str': 'Hypospadias repair'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0227952', 'cui_str': 'Preputial structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0849941,G1 reported significantly higher SWAS and modified HOPE scores compared with G2 (p = 0.001) at all steps of follow-up.,"[{'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Esposito', 'Affiliation': 'Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy. ciroespo@unina.it.'}, {'ForeName': 'Fulvia', 'Initials': 'F', 'LastName': 'Del Conte', 'Affiliation': 'Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Mariapina', 'Initials': 'M', 'LastName': 'Cerulo', 'Affiliation': 'Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Coppola', 'Affiliation': 'Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Pharmacy, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Ricciardi', 'Affiliation': 'Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Crocetto', 'Affiliation': 'Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Castagnetti', 'Affiliation': 'Division of Pediatric Urology, Medical University of Padua, Padua, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Calignano', 'Affiliation': 'Department of Pharmacy, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Escolino', 'Affiliation': 'Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy.'}]",World journal of urology,['10.1007/s00345-020-03419-1']
2618,32852889,Manuka honey versus saline sinus irrigation in the treatment of cystic fibrosis-associated chronic rhinosinusitis: A randomized pilot trial.,"OBJECTIVES


Manuka honey attacks biofilms, which contribute to bacterial persistence in cystic fibrosis sinusitis. The primary objective was to determine feasibility of investigating manuka honey as an irrigation treatment for cystic fibrosis sinusitis and secondarily to assess the treatment's preliminary effectiveness.
DESIGN


Prospective, single-blinded (clinician only), randomized, parallel two-armpilot trial.
SETTING


Tertiary rhinology clinic.
PARTICIPANTS


Subjects had recalcitrantcystic fibrosis sinusitis and previous sinus surgery. They received manuka honey or saline sinus irrigations twice daily for 30 days.
MAIN OUTCOME MEASURES


Main outcomes were recruitment/retention rates andtolerability. Preliminary effectivenesswas assessed based onquality of life Sino-Nasal Outcome Test-22and Lund-Kennedy endoscopic change scores and post-treatment culture negativity.
RESULTS


Over 10 months, 13 subjects were enrolled, and 77% (10/13) were included in the analysis. Manuka honey irrigations were well-tolerated.The quality of lifechange score was clinically significant for manuka honey (-9 [-14,-6]) but not saline (-5 [-9,-1]), although the differencewas not statistically significant (p=0.29). Lund-Kennedy endoscopic change score was significantly better for manuka honey (-3 [-5,-3]) versussaline (0 [0,0]) (p=0.006). There was no difference in post-treatment culture negativity between manuka honey (1/5, 20%) and saline (0/5, 0%) (p=1.00).
CONCLUSIONS


Manuka honey irrigations were well tolerated, and retention rates were high.Preliminary data showed thatmanuka honey achieved a clinically important difference in quality of life score anda significantly better endoscopic outcome. Microbiological controlwas difficult to achieve. A future definitive trial would require multi-institutional recruitment.",2020,"There was no difference in post-treatment culture negativity between manuka honey (1/5, 20%) and saline (0/5, 0%) (p=1.00).
","['Tertiary rhinology clinic', 'Subjects had recalcitrantcystic fibrosis sinusitis and previous sinus surgery', 'cystic fibrosis sinusitis', 'cystic fibrosis-associated chronic rhinosinusitis', '13 subjects were enrolled, and 77% (10/13) were included in the analysis']","['Manuka honey versus saline sinus irrigation', 'manuka honey', 'manuka honey or saline sinus irrigations']","['Lund-Kennedy endoscopic change score', 'retention rates andtolerability', 'quality of life score', 'quality of lifechange score', 'tolerated', 'tolerated, and retention rates']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",13.0,0.0762328,"There was no difference in post-treatment culture negativity between manuka honey (1/5, 20%) and saline (0/5, 0%) (p=1.00).
","[{'ForeName': 'Victoria S', 'Initials': 'VS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA, 98195, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Humphreys', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA, 98195, USA.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Purcell', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA, 98195, USA.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Davis', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA, 98195, USA.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13637']
2619,32850876,"Quality of Life, Anxiety, and Depression in Patients With Early-Stage Mycosis Fungoides and the Effect of Oral Psoralen Plus UV-A (PUVA) Photochemotherapy on it.","Background:  Little is known about psychological discomfort and quality of life (QoL) in early stage mycosis fungoides (MF) and the effect of psoralen plus UV-A (PUVA) on it.  Objective:  To evaluate QoL, anxiety, and depression with validated instruments in early stage MF patients and whether PUVA treatment improves it.  Methods:  Patients with stage IA to IIA MF were treated with PUVA twice weekly for 12-24 weeks, followed by maintenance treatment or not, in a prospective randomized clinical trial. Patients completed a questionnaire on DLQI as well as the Hospital Anxiety and Depression Scale (HADS) prior to therapy, after their last PUVA exposure, and after the PUVA maintenance or observance phase.  Results:  For 24 patients with early stage MF, completed questionnaires were available and analyzed. Prior to treatment, 17% reported strong (DLQI > 10) and 29% moderate impairment (DLQI 6-10) in QoL; 33% of patients reported HADS scores indicating anxiety, and 21% reported scores indicating depression. PUVA significantly improved overall QoL by reducing mean DLQI scores by 58.6% ( p  = 0.003), HADS-A by 30% ( p  = 0.045), and HADS-D by 44% ( p  = 0.002). Improvements in QoL and psychological well-being seemed to be sustained, irrespective of maintenance treatment or not.  Limitations:  Small sample size.  Conclusions:  PUVA sustainably improves QoL and psychological well-being in patients with early stage MF.  Clinical trial registration:  ClinicalTrials.gov identifier: NCT01686594.",2020,"PUVA significantly improved overall QoL by reducing mean DLQI scores by 58.6% ( p  = 0.003),","['patients with early stage MF', 'early stage mycosis fungoides (MF', 'Patients With Early-Stage Mycosis Fungoides', '24 patients with early stage MF', 'Patients with stage IA to IIA MF', 'early stage MF patients']","['Oral Psoralen Plus UV-A (PUVA) Photochemotherapy', 'PUVA', 'psoralen plus UV-A (PUVA']","['Quality of Life, Anxiety, and Depression', 'Hospital Anxiety and Depression Scale (HADS', 'QoL and psychological well-being', 'overall QoL', 'QoL, anxiety, and depression', 'HADS scores indicating anxiety', 'psychological discomfort and quality of life (QoL', 'mean DLQI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0026948', 'cui_str': 'Mycosis fungoides'}, {'cui': 'C0456595', 'cui_str': 'Stage 1A'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016072', 'cui_str': 'Ficusin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0853073', 'cui_str': 'PUVA'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",24.0,0.057439,"PUVA significantly improved overall QoL by reducing mean DLQI scores by 58.6% ( p  = 0.003),","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graier', 'Affiliation': 'Research Unit for Photodermatology, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Fink-Puches', 'Affiliation': 'Research Unit for Photodermatology, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Porkert', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Lang', 'Affiliation': 'Department of Dermatology and Allergology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pöchlauer', 'Affiliation': 'Department of Dermatology, Hietzing Hospital, Vienna, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Ratzinger', 'Affiliation': 'Department of Dermatology Venereology and Allergology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tanew', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Selhofer', 'Affiliation': 'Department of Dermatology and Allergology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Paul-Gunther', 'Initials': 'PG', 'LastName': 'Sator', 'Affiliation': 'Department of Dermatology, Hietzing Hospital, Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hofer', 'Affiliation': 'Research Unit for Photodermatology, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Gruber-Wackernagel', 'Affiliation': 'Research Unit for Photodermatology, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Franz J', 'Initials': 'FJ', 'LastName': 'Legat', 'Affiliation': 'Research Unit for Photodermatology, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Pablo Augusto', 'Initials': 'PA', 'LastName': 'Vieyra-Garcia', 'Affiliation': 'Research Unit for Photodermatology, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Quehenberger', 'Affiliation': 'Institute for Medical Informatics, Statistics, and Documentation, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wolf', 'Affiliation': 'Research Unit for Photodermatology, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria.'}]",Frontiers in medicine,['10.3389/fmed.2020.00330']
2620,32850885,Epidural Anesthesia With Low Concentration Ropivacaine and Sufentanil for Percutaneous Transforaminal Endoscopic Discectomy: A Randomized Controlled Trial.,"Introduction:  Percutaneous transforaminal endoscopic discectomy is a simple and effective treatment for lumbar intervertebral disc herniation, and local anesthesia is often applied in this kind of surgery in many developing countries, including China. However, many patients still feel excruciating pain under this condition. Epidural anesthesia with low-concentration ropivacaine has no impact on muscle strength, and patients might follow the surgeon well during operation. We hypothesize that epidural anesthesia is feasible for percutaneous transforaminal endoscopic discectomy.  Methods:  Two hundred patients with disc herniation who underwent percutaneous transforaminal endoscopic discectomy were randomized to receive either epidural anesthesia or local infiltration anesthesia. Primary outcome measures included the pain score, the cooperation degree, and patients' satisfaction. Mean arterial pressure and heart rate were also recorded.  Results:  Compared with the local anesthesia group, visual analog scale scores, mean arterial pressure, and heart rate were significantly lower in the epidural anesthesia group ( P  < 0.05), and patients' satisfaction was higher. There were no significant differences in the total operation time or blood loss between two groups.  Conclusions:  Epidural anesthesia with low-concentration ropivacaine and sufentanil is safe and effective for percutaneous transforaminal endoscopic discectomy.  Clinical Trial Registration:  ClinicalTrials.gov, identifier: ChiCTR-IOR-17011768.",2020,"Compared with the local anesthesia group, visual analog scale scores, mean arterial pressure, and heart rate were significantly lower in the epidural anesthesia group ( P  < 0.05), and patients' satisfaction was higher.","['Two hundred patients with disc herniation who underwent percutaneous transforaminal endoscopic discectomy', 'Percutaneous Transforaminal Endoscopic Discectomy']","['Percutaneous transforaminal endoscopic discectomy', 'Epidural anesthesia with low-concentration ropivacaine', 'Epidural Anesthesia With Low Concentration Ropivacaine and Sufentanil', 'Epidural anesthesia with low-concentration ropivacaine and sufentanil', 'epidural anesthesia or local infiltration anesthesia', 'epidural anesthesia']","['Mean arterial pressure and heart rate', 'total operation time or blood loss', ""pain score, the cooperation degree, and patients' satisfaction"", 'visual analog scale scores, mean arterial pressure, and heart rate']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",200.0,0.0777415,"Compared with the local anesthesia group, visual analog scale scores, mean arterial pressure, and heart rate were significantly lower in the epidural anesthesia group ( P  < 0.05), and patients' satisfaction was higher.","[{'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yaru', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}]",Frontiers in medicine,['10.3389/fmed.2020.00362']
2621,32851354,Efficacy and brain mechanism of transcutaneous auricular vagus nerve stimulation for adolescents with mild to moderate depression: Study protocol for a randomized controlled trial.,"Background


Depression is a common mental illness in childhood and adolescence, with an incidence of 4%-5%; it can lead to impairments in learning and social functioning. Transcutaneous auricular vagus nerve stimulation (taVNS) is a commonly used method of auricular acupuncture point stimulation, which is regarded as an effective treatment for adults with depression. The aim of this study was to investigate the efficacy and mechanism of taVNS for adolescents with mild to moderate depression.
Methods


This randomized controlled clinical trial will include 120 patients aged 12-16 years, all of whom are diagnosed with mild to moderate depression. Patients will be randomly assigned to a taVNS group and a drug control group (sertraline hydrochloride) at a ratio of 1:1. Patients will be evaluated using the 17-item Hamilton Depression Scale, Hamilton Anxiety Rating Scale, Self-Rating Depression Scale, Self-Rating Anxiety Scale, and Pittsburgh Sleep Quality Index scores at baseline, as well as at the 2nd, 4th, 6th, 8th, and 12th weeks. To investigate the underlying neural mechanisms of taVNS treatment from the perspective of the default mode network, multimodal magnetic resonance imaging (MRI; i.e., structural MRI [sMRI], resting state MRI [rsMRI], and pseudocontinuous arterial spin-labeled [pcASL] MRI) will be used to compare cerebral images among groups. MRI data will also be collected from 40 healthy volunteers to assess whether the participants exhibit normal development of structural and functional components.
Discussion


Depression is the most common mental disorder in adolescence. Drug treatment can improve depression symptoms; however, the side effects of drug treatments are often severe. This study proposes a simple physiotherapy that aims to treat adolescents with mild to moderate depression. The mechanism of taVNS in the treatment of depression will also be investigated. The results of this study will provide evidence to guide the application of taVNS in adolescents with depression.",2020,"Patients will be evaluated using the 17-item Hamilton Depression Scale, Hamilton Anxiety Rating Scale, Self-Rating Depression Scale, Self-Rating Anxiety Scale, and Pittsburgh Sleep Quality Index scores at baseline, as well as at the 2nd, 4th, 6th, 8th, and 12th weeks.","['120 patients aged 12-16 years, all of whom are diagnosed with mild to moderate depression', 'adolescents with mild to moderate depression', 'adults with depression', '40 healthy volunteers', 'adolescents with depression']","['Transcutaneous auricular vagus nerve stimulation (taVNS', 'pseudocontinuous arterial spin-labeled [pcASL] MRI', 'taVNS group and a drug control group (sertraline hydrochloride', 'taVNS', 'transcutaneous auricular vagus nerve stimulation']","['depression symptoms', '17-item Hamilton Depression Scale, Hamilton Anxiety Rating Scale, Self-Rating Depression Scale, Self-Rating Anxiety Scale, and Pittsburgh Sleep Quality Index scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0037914', 'cui_str': 'Spin Labels'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C0600526', 'cui_str': 'Sertraline hydrochloride'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}]",120.0,0.172351,"Patients will be evaluated using the 17-item Hamilton Depression Scale, Hamilton Anxiety Rating Scale, Self-Rating Depression Scale, Self-Rating Anxiety Scale, and Pittsburgh Sleep Quality Index scores at baseline, as well as at the 2nd, 4th, 6th, 8th, and 12th weeks.","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Psychiatry Beijing First Hospital of Integrated Chinese and Western Medicine Beijing China.'}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Acupuncture and Moxibustion Beijing First Hospital of Integrated Chinese and Western Medicine Beijing China.'}, {'ForeName': 'Zhangjing', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Chinese Medicine University of Hong Kong Shenzhen Hospital (HKU-SZH) Shenzhen Guangdong China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Psychiatry Beijing Children's Hospital Capital Medical University National Center for Children's Health Beijing China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Psychiatry Beijing First Hospital of Integrated Chinese and Western Medicine Beijing China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology Beijing First Hospital of Integrated Chinese and Western Medicine Beijing China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Psychiatry Beijing First Hospital of Integrated Chinese and Western Medicine Beijing China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': ""Department of Medical imaging Guang'anmen Hospital China Academy of Chinese Medical Sciences Beijing China.""}]",Pediatric investigation,['10.1002/ped4.12198']
2622,32851365,Efficacy and Safety of Opinercept Tumor Necrosis Factor Inhibitor Therapy for Drug-Refractory Rheumatoid Arthritis: A Randomized Clinical Trial.,"Objectives


This study aims to evaluate the efficacy and safety profile of opinercept for rheumatoid arthritis (RA) patients undergoing disease- modifying anti-rheumatic drugs (DMARDs) therapy.
Patients and methods


A total of 98 patients with active RA (17 males, 81 females; mean age 58.6±12.2 years; range, 24.3 to 85.3 years) were randomized into opinercept plus DMARDs (OD group) or placebo plus DMARDs (PD group), in a 24-week treatment period. Primary outcome was American College of Rheumatology score (ACR20) at week 24. Other exploratory endpoints included ACR50, ACR70 and disease activity score-28 (DAS28) at week 12 and 24, tender/swollen joint counts, pain, Health Assessment Questionnaire-Disability Index, erythrocyte sedimentation rate, and C-reactive protein level. Incidence of adverse events (AEs), vital signs and physical findings, and laboratory test results were also evaluated.
Results


Patients in OD group showed significantly higher achievement percentage of ACR20 at week 24 than the PD group (76.6% vs. 30.3%, p<0.001). The evaluation of DAS28 was significantly improved in OD patients compared to PD patients at weeks 12 and 24. Most of the occurred AEs were mild or moderate and considered unrelated to study treatments.
Conclusion


Opinercept concurrent with DMARDs was superior to DMARDs alone in slowing RA progression and ameliorating symptoms, with well- tolerated and acceptable safety profile.",2020,"Patients in OD group showed significantly higher achievement percentage of ACR20 at week 24 than the PD group (76.6% vs. 30.3%, p<0.001).","['98 patients with active RA (17 males, 81 females; mean age 58.6±12.2 years; range, 24.3 to 85.3 years', 'Drug-Refractory Rheumatoid Arthritis', 'rheumatoid arthritis (RA) patients undergoing disease- modifying anti-rheumatic drugs (DMARDs) therapy']","['Opinercept Tumor Necrosis Factor Inhibitor Therapy', 'opinercept', 'opinercept plus DMARDs (OD group) or placebo plus DMARDs (PD group']","['Incidence of adverse events (AEs), vital signs and physical findings, and laboratory test results', 'ACR50, ACR70 and disease activity score-28 (DAS28) at week 12 and 24, tender/swollen joint counts, pain, Health Assessment Questionnaire-Disability Index, erythrocyte sedimentation rate, and C-reactive protein level', 'evaluation of DAS28', 'Efficacy and Safety', 'ACR20', 'efficacy and safety profile', 'American College of Rheumatology score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",98.0,0.0953373,"Patients in OD group showed significantly higher achievement percentage of ACR20 at week 24 than the PD group (76.6% vs. 30.3%, p<0.001).","[{'ForeName': 'Toong-Hua', 'Initials': 'TH', 'LastName': 'Liang', 'Affiliation': 'Department of Internal Medicine, Taipei City Hospital Renai Branch, Taipei, Taiwan.'}, {'ForeName': 'Chyou-Shen', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shinn-Shing', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chien-Sheng', 'Initials': 'CS', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kun-Hung', 'Initials': 'KH', 'LastName': 'Chen', 'Affiliation': 'Division of Rheumatology and Immunology, Cathay General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ping-Ning', 'Initials': 'PN', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University, Graduate Institute of Immunology, College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Cheng Hsin General Hospital, Taipei, Taiwan.'}]",Archives of rheumatology,['10.46497/ArchRheumatol.2020.7464']
2623,32851411,Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Coadministered With an Influenza Vaccine in Older Adults.,"BACKGROUND


Respiratory syncytial virus (RSV) and influenza cause significant disease burden in older adults. Overlapping RSV and influenza seasonality presents the opportunity to coadminister vaccines for both infections. This study assessed coadministration of the investigational vaccine, Ad26.RSV.preF, an adenovirus serotype 26 (Ad26) vector encoding RSV F protein stabilized in its prefusion conformation (pre-F), with a seasonal influenza vaccine in older adults.
METHODS


In this phase 2a, double-blind, placebo-controlled study, 180 adults aged ≥60 years received Ad26.RSV.preF plus Fluarix on day 1 and placebo on day 29, or placebo plus Fluarix on day 1 and Ad26.RSV.preF on day 29 (control).
RESULTS


The coadministration regimen had an acceptable tolerability profile. Reactogenicity was generally higher after Ad26.RSV.preF versus Fluarix, but symptoms were generally transient and mild or moderate. At 28 days after the first vaccination, the upper confidence intervals of the hemagglutination inhibition antibody geometric mean ratio (control/coadministration) for all influenza strains were <2, demonstrating noninferiority. Robust neutralizing and binding antibody responses to RSV A2 were observed in both groups.
CONCLUSIONS


Coadministration of Fluarix with Ad26.RSV.preF vaccine had an acceptable safety profile and showed no evidence of interference in immune response. The results are compatible with simultaneous seasonal vaccination with both vaccines.
CLINICAL TRIALS REGISTRATION


NCT03339713.",2020,"Reactogenicity was generally higher after Ad26.RSV.preF versus Fluarix, but symptoms were generally transient and mild or moderate.","['older adults', 'Older Adults', '180 adults aged ≥60 years received']","['investigational vaccine, Ad26.RSV.preF, an adenovirus serotype 26 (Ad26) vector encoding RSV F protein stabilized', 'seasonal influenza vaccine', 'Ad26.RSV.preF plus Fluarix on day 1 and placebo', 'placebo plus Fluarix', 'Ad26.RSV.preF', 'Ad26.RSV.preF vaccine', 'placebo', 'Investigational Vaccine Coadministered With an Influenza Vaccine']","['Safety and Immunogenicity', 'acceptable tolerability profile', 'Reactogenicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0591524', 'cui_str': 'fluarix'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",180.0,0.366646,"Reactogenicity was generally higher after Ad26.RSV.preF versus Fluarix, but symptoms were generally transient and mild or moderate.","[{'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Sadoff', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'De Paepe', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Haazen', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Omoruyi', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Arangassery R', 'Initials': 'AR', 'LastName': 'Bastian', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Comeaux', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Heijnen', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Strout', 'Affiliation': 'Coastal Carolina Research Center, Mount Pleasant, South Carolina.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Callendret', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa409']
2624,32851418,Reply to Letter to Editor: Safety of one-stage bilateral total knee arthroplasty-one-surgeon sequential vs. two surgeons simultaneous: a randomized controlled study.,,2020,,[],['one-stage bilateral total knee arthroplasty-one-surgeon sequential vs. two surgeons simultaneous'],[],[],"[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],,0.070912,,"[{'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Güngören', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04783-8']
2625,32851420,"Context, acute tolerance, and subjective response affect alcohol-impaired driving decisions.","RATIONALE


Alcohol intoxication produces effects that can impair judgment and increase engagement in risky behaviors, including alcohol-impaired driving (AID). Real-world AID decisions are informed by contextual circumstances and judgments of associated risk. How individuals vary in their AID decision-making across contexts and whether subjective alcohol responses (stimulation, sedation, acute tolerance) differentially affect AID decisions are critical, but under-studied research questions.
OBJECTIVES


We systematically investigated predictors of AID decisions at different hypothetical driving distances across the blood alcohol concentration (BAC) curve.
METHODS


Young adults (n = 40; 55% female) completed two laboratory sessions in a within-subjects alcohol/placebo design. At multiple points along the BAC curve (M peak BAC = 0.101 g%), participants rated their subjective intoxication, stimulation, sedation, and perceived dangerousness of driving prior to indicating their willingness to drive distances of 1, 3, and 10 miles. Multilevel mixed models assessed within- and between-person predictors of the maximum distance participants were willing to drive at matched BACs on the ascending and descending limb.
RESULTS


Under intoxication (but not placebo), participants were willing to drive greater distances on the descending versus ascending limb. At the momentary level, participants were willing to drive further when they felt less intoxicated, stimulated, and sedated, and perceived driving as less dangerous.
CONCLUSIONS


Individuals differed in the distance they were willing to drive as a function of indicators of intoxication, implicating driving distance as an important contextual factor relevant to AID decisions. Individuals may simultaneously perceive themselves as ""unsafe"" to drive, but ""safe enough"" to drive short distances, particularly when BAC is falling.",2020,"Individuals may simultaneously perceive themselves as ""unsafe"" to drive, but ""safe enough"" to drive short distances, particularly when BAC is falling.",['Young adults (n = 40; 55% female'],"['placebo', 'laboratory sessions in a within-subjects alcohol/placebo']","['subjective intoxication, stimulation, sedation, and perceived dangerousness of driving prior to indicating their willingness to drive distances', 'blood alcohol concentration (BAC) curve', 'risky behaviors, including alcohol-impaired driving (AID', 'acute tolerance, and subjective response affect alcohol-impaired driving decisions']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0010968', 'cui_str': 'Dangerousness'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",,0.0315137,"Individuals may simultaneously perceive themselves as ""unsafe"" to drive, but ""safe enough"" to drive short distances, particularly when BAC is falling.","[{'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Motschman', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, 212D McAlester Hall, Columbia, MO, 65211, USA.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Warner', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, 212D McAlester Hall, Columbia, MO, 65211, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Wycoff', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, 212D McAlester Hall, Columbia, MO, 65211, USA.'}, {'ForeName': 'Clintin P', 'Initials': 'CP', 'LastName': 'Davis-Stober', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, 212D McAlester Hall, Columbia, MO, 65211, USA.'}, {'ForeName': 'Denis M', 'Initials': 'DM', 'LastName': 'McCarthy', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, 212D McAlester Hall, Columbia, MO, 65211, USA. mccarthydm@missouri.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05639-0']
2626,32851421,"CDP-choline and galantamine, a personalized α7 nicotinic acetylcholine receptor targeted treatment for the modulation of speech MMN indexed deviance detection in healthy volunteers: a pilot study.","RATIONALE


The combination of CDP-choline, an α7 nicotinic acetylcholine receptor (α7 nAChR) agonist, with galantamine, a positive allosteric modulator of nAChRs, is believed to counter the fast desensitization rate of the α7 nAChRs and may be of interest for schizophrenia (SCZ) patients. Beyond the positive and negative clinical symptoms, deficits in early auditory prediction-error processes are also observed in SCZ. Regularity violations activate these mechanisms that are indexed by electroencephalography-derived mismatch negativity (MMN) event-related potentials (ERPs) in response to auditory deviance.
OBJECTIVES/METHODS


This pilot study in thirty-three healthy humans assessed the effects of an optimized α7 nAChR strategy combining CDP-choline (500 mg) with galantamine (16 mg) on speech-elicited MMN amplitude and latency measures. The randomized, double-blinded, placebo-controlled, and counterbalanced design with a baseline stratification method allowed for assessment of individual response differences.
RESULTS


Increases in MMN generation mediated by the acute CDP-choline/galantamine treatment in individuals with low baseline MMN amplitude for frequency, intensity, duration, and vowel deviants were revealed.
CONCLUSIONS


These results, observed primarily at temporal recording sites overlying the auditory cortex, implicate α7 nAChRs in the enhancement of speech deviance detection and warrant further examination with respect to dysfunctional auditory deviance processing in individuals with SCZ.",2020,"Regularity violations activate these mechanisms that are indexed by electroencephalography-derived mismatch negativity (MMN) event-related potentials (ERPs) in response to auditory deviance.
","['individuals with SCZ', 'healthy volunteers', 'thirty-three healthy humans']","['galantamine', 'placebo', 'optimized α7 nAChR strategy combining CDP-choline', 'CDP-choline and galantamine']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034830', 'cui_str': 'Nicotinic receptor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}]",[],33.0,0.0825815,"Regularity violations activate these mechanisms that are indexed by electroencephalography-derived mismatch negativity (MMN) event-related potentials (ERPs) in response to auditory deviance.
","[{'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Choueiry', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Ottawa, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada. joelle.choueiry@theroyal.ca.'}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Blais', 'Affiliation': 'Institute of Cognitive Science, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Dhrasti', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry, The Royal Ottawa Mental Health Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychology, Faculty of Social Sciences, Mount Saint Vincent University, Halifax, NS, Canada.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Illivitsky', 'Affiliation': 'Department of Psychiatry, The Royal Ottawa Mental Health Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Verner', 'Initials': 'V', 'LastName': 'Knott', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Ottawa, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.'}]",Psychopharmacology,['10.1007/s00213-020-05646-1']
2627,32851435,Introducing free response short answer questions in anatomy spot tests: experiment study.,"PURPOSE


A spot test is commonly used to assess practical knowledge through a series of specific questions related to the marked anatomical structures on cadavers. However, the continuous reviewing and developing of the medical curricula demands the need to improve the assessment method of the practical examination of anatomical knowledge. Therefore, the aim of the study was to examine the effectiveness of a free response short-answer questions (FRSAQs) test and traditional questions on medical students' performance.
METHODS


This is an experimental study using a Randomized Posttest-Only Control Group Design to compare the mean of students' performance in addition to their perceptions about the two versions of the spot tests. Two hundred and ninety preclinical-year medical students were invited to participate in this study.
RESULTS


Only 109 (38%) students participated in this study. The data analysis showed a significant improvement in students' performance in the FRSAQs test (5.3 ± 2.7) than the traditional spot test (4.7 ± 2.6), (P = 0.04). The majority of the students (70%) preferred the FRSAQs spot test, citing that it is good test to assess practical knowledge. The psychometric analysis revealed that the FRSAQs produced more ideal stations (60%) when compared to the traditional spot test (10%).
CONCLUSION


The current study found that the FRSAQs spot test had a significant impact on students' performance, and it was considered an ideal, flexible, and stress-free assessment method when compared to the traditional spot test. Implementation of the strategy in teaching and in assessment is recommended.",2020,"The psychometric analysis revealed that the FRSAQs produced more ideal stations (60%) when compared to the traditional spot test (10%).
","[""medical students' performance"", 'Only 109 (38%) students participated in this study', 'Two hundred and ninety preclinical-year medical students']",['free response short-answer questions (FRSAQs) test and traditional questions'],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]",[],290.0,0.0170839,"The psychometric analysis revealed that the FRSAQs produced more ideal stations (60%) when compared to the traditional spot test (10%).
","[{'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alraddadi', 'Affiliation': 'Department of Basic Medical Sciences, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS), P.O.Box.3660, Riyadh, 11481, Saudi Arabia. aalraddadi.2012@gmail.com.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Hoja', 'Affiliation': 'Department of Basic Medical Sciences, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS), P.O.Box.3660, Riyadh, 11481, Saudi Arabia.'}, {'ForeName': 'Haifa', 'Initials': 'H', 'LastName': 'Alhawas', 'Affiliation': 'Department of Basic Medical Sciences, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS), P.O.Box.3660, Riyadh, 11481, Saudi Arabia.'}, {'ForeName': 'Bader', 'Initials': 'B', 'LastName': 'Khawaji', 'Affiliation': 'King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard, Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Alharbi', 'Affiliation': 'King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard, Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sajida', 'Initials': 'S', 'LastName': 'Agha', 'Affiliation': 'King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard, Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Masuadi', 'Affiliation': 'King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard, Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohi Eldin', 'Initials': 'ME', 'LastName': 'Magzoub', 'Affiliation': 'Department of Medical Education, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates.'}]",Surgical and radiologic anatomy : SRA,['10.1007/s00276-020-02550-3']
2628,32851466,Evaluation of a remote-controlled laparoscopic camera holder for basic laparoscopic skills acquisition: a randomized controlled trial.,"BACKGROUND


Unsteady camera movement and poor visualization contribute to a difficult learning curve for laparoscopic surgery. Remote-controlled camera holders (RCHs) aim to mitigate these factors and may be used to overcome barriers to learning. Our aim was to evaluate performance benefits to laparoscopic skill acquisition in novices using a RCH.
METHODS


Novices were randomized into groups using a human camera assistant (HCA) or the FreeHand v1.0 RCH and trained in the (E-BLUS) curriculum. After completing training, a surgical workload questionnaire (SURG-TLX) was issued to participants.
RESULTS


Forty volunteers naïve in laparoscopic skill were randomized into control and intervention groups (n = 20) with intention-to-treat analysis. Each participant received up to 10 training sessions using the E-BLUS curriculum. Competency was reached in the peg transfer task in 5.5 and 7.6 sessions for the ACH and HCA groups, respectively (P = 0.015), and 3.6 and 6.8 sessions for the laparoscopic suturing task (P = 0.0004). No significance differences were achieved in the circle cutting (P = 0.18) or needle guidance tasks (P = 0.32). The RCH group experienced significantly lower workload (P = 0.014) due to lower levels of distraction (P = 0.047).
CONCLUSIONS


Remote-controlled camera holders have demonstrated the potential to significantly benefit intra-operative performance and surgical experience where camera movement is minimal. Future high-quality studies are needed to evaluate RCHs in clinical practice.
TRIAL REGISTRATION


ISRCTN 83733979.",2020,No significance differences were achieved in the circle cutting (P = 0.18) or needle guidance tasks (P = 0.32).,"['Forty volunteers naïve in laparoscopic skill', 'Novices']","['Remote-controlled camera holders (RCHs', 'surgical workload questionnaire (SURG-TLX', 'human camera assistant (HCA) or the FreeHand v1.0 RCH and trained in the (E-BLUS) curriculum', 'RCH', 'remote-controlled laparoscopic camera holder']","['needle guidance tasks', 'circle cutting']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C1551377', 'cui_str': 'Holder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1505678', 'cui_str': 'CD46 protein, human'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}]",40.0,0.0852789,No significance differences were achieved in the circle cutting (P = 0.18) or needle guidance tasks (P = 0.32).,"[{'ForeName': 'Mohammad S A', 'Initials': 'MSA', 'LastName': 'Amin', 'Affiliation': ""MRC Centre for Transplantation, King's College London, Guy's Hospital, King's Health Partners, London, SE1 9RT, UK.""}, {'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Aydin', 'Affiliation': ""MRC Centre for Transplantation, King's College London, Guy's Hospital, King's Health Partners, London, SE1 9RT, UK.""}, {'ForeName': 'Nurhan', 'Initials': 'N', 'LastName': 'Abbud', 'Affiliation': ""MRC Centre for Transplantation, King's College London, Guy's Hospital, King's Health Partners, London, SE1 9RT, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Van Cleynenbreugel', 'Affiliation': 'Department of Urology, University Leuven, Leuven, Belgium.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Veneziano', 'Affiliation': 'Department of Urology and Renal Transplantation, Bianchi-Melacrino-Morelli Hospital, Reggio Calabria, Italy.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Somani', 'Affiliation': 'Department of Urology, Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Ali Serdar', 'Initials': 'AS', 'LastName': 'Gözen', 'Affiliation': 'Department of Urology, SLK-Kliniken, University of Heidelberg, Heilbronn, Germany.'}, {'ForeName': 'Juan Palou', 'Initials': 'JP', 'LastName': 'Redorta', 'Affiliation': 'Department of Urology, Fundació Puigvert, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'M Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""MRC Centre for Transplantation, King's College London, Guy's Hospital, King's Health Partners, London, SE1 9RT, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""MRC Centre for Transplantation, King's College London, Guy's Hospital, King's Health Partners, London, SE1 9RT, UK.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Makanjuoala', 'Affiliation': ""Department of Urology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, Guy's Hospital, King's Health Partners, London, SE1 9RT, UK. Kamran.ahmed@kcl.ac.uk.""}]",Surgical endoscopy,['10.1007/s00464-020-07899-5']
2629,32851483,Acute effects of inspiratory muscle training at different intensities in healthy young people.,"BACKGROUND


Understanding the acute effects of inspiratory muscle training (IMT) at different intensities on the autonomic nervous system, arterial stiffness, and blood pressure in healthy young people will be important in the constitution of appropriate IMT prescriptions.
AIMS


To investigate the acute effects of IMT at different intensities on autonomic function, arterial stiffness, and blood pressure in healthy young people METHODS: Thirty-six healthy participants were enrolled in this crossover study. All participants randomly performed IMT sessions, which consisted of diaphragmatic breathing exercise (DBE), 10%, 30%, and 60% of maximal inspiratory pressure (MIP) on consecutive days. Autonomic function and arterial stiffness were assessed by measuring heart rate variability (HRV) and aortic pulse wave velocity (AoPWV), respectively. HRV, AoPWV, and blood pressure were recorded before and immediately after each IMT session.
RESULTS


There was no significant difference in the baseline measurements between IMT sessions (p > 0.05). Heart rate (HR) significantly decreased after DBE and IMT at 10% of MIP (p < 0.05). All time domain parameters of HRV significantly improved after DBE compared with the baseline (p < 0.05). There was no difference in the frequency domain of HRV after the IMT sessions (p > 0.05). AoPWV significantly increased after IMT at 60% of MIP (p < 0.05). Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05).
CONCLUSIONS


A single session of DBE positively affects autonomic function and blood pressure, while IMT at 60% of MIP increases arterial stiffness. The different intensities of IMT have various impacts on autonomic function, arterial stiffness, and blood pressure.
TRIAL REGISTRATION


NCT03788356.",2020,"Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05).
","['healthy young people METHODS', 'healthy young people', 'Thirty-six healthy participants']","['IMT', 'maximal inspiratory pressure (MIP', 'diaphragmatic breathing exercise (DBE', 'inspiratory muscle training (IMT', 'inspiratory muscle training']","['HRV, AoPWV, and blood pressure', 'frequency domain of HRV', 'autonomic function, arterial stiffness, and blood pressure', 'Autonomic function and arterial stiffness', 'autonomic function and blood pressure', 'Heart rate (HR', 'Mean arterial pressure', 'AoPWV', 'heart rate variability (HRV) and aortic pulse wave velocity (AoPWV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",36.0,0.0436921,"Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05).
","[{'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Tanriverdi', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylül University, Izmir, Turkey. tanrverdiaylin@gmail.com.'}, {'ForeName': 'Buse Ozcan', 'Initials': 'BO', 'LastName': 'Kahraman', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Ozsoy', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Ozpelit', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02353-w']
2630,32851490,Oral water ingestion in the treatment of shock patients: a prospective randomized study.,,2020,,['shock patients'],['Oral water ingestion'],[],"[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",[],,0.0239991,,"[{'ForeName': 'Pierre-Grégoire', 'Initials': 'PG', 'LastName': 'Guinot', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France. guinotpierregregoire@gmail.com.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Valerian', 'Initials': 'V', 'LastName': 'Duclos', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Soudry-Faure', 'Affiliation': 'Unité de Soutien Méthodologique, DRCI, Dijon Bourgogne University Hospital, 21000, Dijon, France.'}, {'ForeName': 'Belaid', 'Initials': 'B', 'LastName': 'Bouhemad', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06215-y']
2631,32851513,Desflurane and sevoflurane concentrations in blood passing through the oxygenator during cardiopulmonary bypass: a randomized prospective pilot study.,"PURPOSE


Volatile anesthetics (VAs) protect myocardial cells in cardiovascular surgery. A recent clinical trial of cardiopulmonary bypass (CPB) surgery reported no significant difference in mortality rates between the use of VAs and total intravenous anesthetics at 1 year postoperatively. However, oxygenator function may affect the VA pharmacokinetics. Thus, we measured the VA blood concentrations during CPB in patients managed with four different microporous polypropylene hollow fiber membrane oxygenators.
METHODS


Twenty-four patients scheduled for elective CPB were randomly allocated to one of the two VA groups (desflurane and sevoflurane groups) and, then, randomly divided into one of four oxygenator groups: Terumo, LivaNova, Medtronic, and Senko (n = 3). Additionally, in each VA group, three patients were randomly selected and redundantly allocated to the human lung group (for control blood VA concentration without oxygenator). Blood samples collected 20 min after starting 6.0 vol% desflurane or 1.7 vol% sevoflurane were analyzed using gas chromatography. Oxygenator-related complications and structural changes in the membrane surface of each oxygenator after surgery were evaluated.
RESULTS


The mean (standard deviation) concentrations of desflurane and sevoflurane in the human lung were 182.4 (23.2) and 54.0 (9.6) μg/ml, respectively; not significantly different from those in the four oxygenator groups. No oxygenator-related complications occurred. Structural changes in membrane fibers did not occur after clinical use, except for difficulty in image acquisition with Senko products.
CONCLUSION


Our results demonstrated that the blood concentrations of desflurane and sevoflurane passing through oxygenators used during CPB were similar to those in the human lung control.",2020,No oxygenator-related complications occurred.,"['patients managed with four different microporous polypropylene hollow fiber membrane oxygenators', 'Twenty-four patients scheduled for elective CPB', 'blood passing through the oxygenator during cardiopulmonary bypass']","['VA groups (desflurane and sevoflurane', 'LivaNova, Medtronic, and Senko', 'desflurane or 1.7 vol% sevoflurane', 'human lung group (for control blood VA concentration without oxygenator', 'Desflurane', 'Volatile anesthetics (VAs', 'cardiopulmonary bypass (CPB) surgery']","['VA blood concentrations', 'blood concentrations', 'mortality rates', 'mean (standard deviation) concentrations of desflurane and sevoflurane']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0032582', 'cui_str': 'Polypropylene'}, {'cui': 'C0475405', 'cui_str': 'Hollow fiber membrane'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]",24.0,0.0610064,No oxygenator-related complications occurred.,"[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan. takahiro@med.nagoya-u.ac.jp.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Department of Perioperative Management System, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ishii', 'Affiliation': 'Department of Legal Medicine and Bioethics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kubo', 'Affiliation': 'Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02844-1']
2632,32846768,Study on the clinical assessment of integrated rehabilitation of Traditional Chinese Medicine and western medication for acute myocardial infarction.,"OBJECTIVE


This trial aims to evaluate the efficacy and safety of the Baduanjin exercise in patients with acute myocardial infarction (AMI).
METHODS


A single-center, open, randomized controlled clinical trial will be conducted to evaluate the effectiveness of the Baduanjin exercise on the rehabilitation of AMI patients. It plans to enroll 64 patients. Patients will be divided evenly into 2 groups using a random number table method. There will be 32 cases in each group. Patients in the experimental group will be treated with standardized drug therapy combined with Baduanjin exercise, while patients in the control group will be treated with standardized drug therapy combined with routine exercise. The primary outcome is the peak oxygen consumption (Peak VO2) during cardiopulmonary exercise test (CPET). The secondary outcomes include CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc. DISCUSSION:: This study will be the first to evaluate the effect of the Baduanjin exercise on the Peak VO2 in patients with AMI.
STUDY REGISTRATION


This study has been registered on the Chinese Clinical Trial Registry (No: ChiCTR1800016209, protocol version 1.2).",2020,"The secondary outcomes include CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc.","['acute myocardial infarction', 'patients with acute myocardial infarction (AMI', 'patients with AMI', 'AMI patients']","['standardized drug therapy combined with Baduanjin exercise', 'Traditional Chinese Medicine and western medication', 'standardized drug therapy combined with routine exercise', 'Baduanjin exercise']","['efficacy and safety', 'peak oxygen consumption (Peak VO2) during cardiopulmonary exercise test (CPET', 'CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0686368,"The secondary outcomes include CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc.","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Lishuo', 'Initials': 'L', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Lindan', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021592']
2633,32846775,The effect of stem cell therapy and comprehensive physical therapy in motor and non-motor symptoms in patients with multiple sclerosis: A comparative study.,"INTRODUCTION


People with multiple sclerosis (PwMS) experience a wide range of disabilities which negatively impact their quality of life (QOL). Several interventions have been used in PwMS such as medication, physical therapy exercises and stem cell therapy to improve their QOL. However, there is a limited evidence on the benefits of combining interventions. The purpose of this study is to explore the effect of combining physical therapy exercises (PTE) and Wharton Jelly mesenchymal stem cell (WJ-MSCs) injections on motor and non-motor symptoms versus each intervention alone in PwMS.
METHODS


Sixty PwMS will be allocated to either PTE, WJ-MSCs, or a combined group, followed up for 12 months and examined using a comprehensive battery of measures. Participants in the PTE group will receive 2 sessions per week of a supervised exercise program for 6 months followed by a home exercise program for another 6 months. The WJ-MSCs group will receive 3 WJ-MSCs injections in the first 6 months then they will be encouraged to follow an active life style. The third group will receive both interventions.
DISCUSSION


This study will aid in a better understanding of the combined effect of physical therapy and mesenchymal stem cell therapy. The results from this proposed study may reduce disability, improve QOL in PwMS, and consequently, reduce the cost associated with the life-time care of these individuals worldwide.
TRIAL REGISTRATION NUMBER


NCT03326505.",2020,"The results from this proposed study may reduce disability, improve QOL in PwMS, and consequently, reduce the cost associated with the life-time care of these individuals worldwide.
","['PwMS', 'Sixty PwMS', 'patients with multiple sclerosis']","['physical therapy and mesenchymal stem cell therapy', 'physical therapy exercises (PTE) and Wharton Jelly mesenchymal stem cell (WJ-MSCs) injections', 'stem cell therapy and comprehensive physical therapy', 'supervised exercise program for 6 months followed by a home exercise program', 'PTE, WJ-MSCs']",['quality of life (QOL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0230987', 'cui_str': ""Structure of Wharton's jelly""}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0266785,"The results from this proposed study may reduce disability, improve QOL in PwMS, and consequently, reduce the cost associated with the life-time care of these individuals worldwide.
","[{'ForeName': 'Alia A', 'Initials': 'AA', 'LastName': 'Alghwiri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Jamali', 'Affiliation': 'Cell Therapy Center, the University of Jordan, Amman.'}, {'ForeName': 'Mayis', 'Initials': 'M', 'LastName': 'Aldughmi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Khalil', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid.'}, {'ForeName': 'Alham', 'Initials': 'A', 'LastName': 'Al-Sharman', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Alhattab', 'Affiliation': 'Laboratory for Nanomedicine, Division of Biological & Environmental Science & Engineering (BESE), King Abdullah University of Science and Technology (KAUST), Thuwal, 23955-6900, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Radaideh', 'Affiliation': 'Department of Medical Imaging, Faculty of Applied Medical Sciences, Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Abdalla', 'Initials': 'A', 'LastName': 'Awidi', 'Affiliation': 'Cell Therapy Center, the University of Jordan, Amman.'}]",Medicine,['10.1097/MD.0000000000021646']
2634,32846782,The efficacy and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty: A protocol of randomized controlled trial.,"BACKGROUND


Concerns exist regarding the analgesia effect and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the dexamethasone administration, and investigate its clinical applicability. We thus further designed a randomized controlled study to assess the different dose of dexamethasone on postoperative pain and complications in patients undergoing unicompartmental knee arthroplasty.
METHODS


This randomized, prospective, controlled study was carried out between January 2018 and August 2019. It was approved by the institutional review board in our hospital (HBRM2020013). A total of 80 patients were randomly assigned to each group: the study group (n = 40) and the control group (n = 40). All surgical procedures were performed by a similar orthopedic surgeon. In the study group, patients received intravenously 20 mg dexamethasone (4 mL, Tianjin Kingyork group Co., Ltd., China) just after the anesthesia, and repeated at 24 hours after the surgery. Patients in the control group received intravenously 10 mg dexamethasone solution (2 mL) just after the anesthesia, and repeated at 24 hours after the surgery. CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively.
CONCLUSION


We hypothesized that patients receiving multiple doses of dexamethasone was associated with better outcomes compared with patients receiving single dose of dexamethasone.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5770).",2020,"CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively.
","['80 patients', 'January 2018 and August 2019', 'unicompartmental knee arthroplasty', 'patients undergoing unicompartmental knee arthroplasty']","['dexamethasone', 'intravenously 10\u200amg dexamethasone solution']","['efficacy and safety', 'postoperative pain and complications', 'CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520905', 'cui_str': 'Postoperative vomiting'}]",80.0,0.170952,"CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively.
","[{'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesia, Hanchuan People's Hospital.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesia, Hanchuan People's Hospital.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, Renmin Hospital of Wuhan University/Hubei General Hospital, Hubei, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': ""Department of Anesthesia, Hanchuan People's Hospital.""}]",Medicine,['10.1097/MD.0000000000021671']
2635,32846798,The efficacy and safety of intravenous tranexamic acid in anterior cruciate ligament reconstruction: A randomized controlled trial protocol.,"BACKGROUND


The safety and efficacy of intravenous tranexamic acid (TXA) in the anterior cruciate ligament (ACL) reconstruction remains controversial. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the TXA administration, and investigate its clinical applicability. The purpose of this work is to assess the safety and efficacy of the intravenous TXA in decreasing perioperative blood loss in the patients undergoing ACL reconstruction.
METHODS


This randomized, controlled, prospective research was carried out between January 2017 and January 2018. All the patients and their family members signed the informed consent forms, and this current work was authorized via the ethics committee of Nanjing first hospital (registration No.: NJU1003586). A total of 100 patients were divided randomly into 2 group: the control group (n = 50) and study group (n = 50). The study group receives intravenous TXA administration [1 g] before skin incision. The control group receives equivalent normal saline. Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded. The measures of secondary outcomes refer to the clinical data involving the range of motion and postoperative pain score. The pain score was quantified by utilizing the 10-cm scale of visual analog. The pain strength was in the range of 0-10, where 0 is totally no pain and 10 represents the most severe pain.
RESULTS


This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention.
CONCLUSION


Our results can bring a new perspective on the use of TXA after arthroscopically assisted ACL surgery.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5798).",2020,"Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded.","['anterior cruciate ligament (ACL', 'anterior cruciate ligament reconstruction', 'January 2017 and January 2018', 'patients undergoing ACL reconstruction', '100 patients']","['tranexamic acid (TXA', 'tranexamic acid', 'equivalent normal saline', 'TXA', 'intravenous TXA administration [1 g] before skin incision']","['perioperative blood loss', 'efficacy and safety', 'pain strength', 'safety and efficacy', 'clinical data involving the range of motion and postoperative pain score', 'pain score', 'blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",100.0,0.0429763,"Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded.","[{'ForeName': 'Hongyao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of sports and joint, Nanjing Hospital Affiliated to Nanjing Medical University (Nanjing first hospital), Jiangsu, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Xiangjie', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021747']
2636,32845862,"Effectiveness of nutrition education in improving fruit and vegetable consumption among selected college students in urban Puducherry, South India. A pre-post intervention study.","Objectives World Health Organization (WHO) suggests intake of five servings (400 g) of fruits and vegetables (F&V) per day to ensure an adequate dietary fibre and to reduce the risk of non-communicable diseases. Risk factor survey of Non-Communicable Diseases (2007-08), reports that only 1% population in Tamil Nadu, South India consumed more than five servings a day. So we aimed to assess the effectiveness of nutrition education in improving the daily intake of fruit and vegetable servings and stage of behaviour change among college students. Methods A pre-post intervention study was conducted among undergraduate students from two selected women's colleges in urban Puducherry, South India during September-October 2019. The two English departments were randomly allocated into intervention group (IG), control group (CG) and 75 students in each group were chosen by systematic random sampling. IG received 30 min of nutrition education programme; which includes importance and minimum daily intake of fruits & vegetables, local availability, cost and awareness about myths and misconceptions. CG received pamphlets regarding healthy dietary intake. Knowledge regarding portion sizes, average daily servings of fruit & vegetable intake and stage of behaviour change were assessed at baseline and after one month of intervention. Results There was a significant increase in knowledge regarding portion sizes (28- 64%) after intervention in IG (p<0.001) compared to CG (24- 40%). The knowledge regarding the required number of servings of fruits (27-56%) and vegetables (15-58%) also increased significantly (p<0.001) in the IG. Intake of fruits, vegetables and juices in the last 24 h were significantly increased in IG compared to CG (p<0.001). There was a significant increase (p=0.002) in contemplation and preparation stage (13-34%) in IG after intervention. Conclusions A well designed nutrition education programme is an effective tool in promoting healthy eating habits among adolescents. It enabled a significant increase in knowledge regarding portion sizes of F&V and daily intake of fruits and vegetables.",2020,There was a significant increase (p=0.002) in contemplation and preparation stage (13-34%) in IG after intervention.,"['selected college students in urban Puducherry, South India', 'healthy eating habits among adolescents', 'college students', ""undergraduate students from two selected women's colleges in urban Puducherry, South India during September-October 2019""]","['nutrition education', 'nutrition education programme', 'CG received pamphlets regarding healthy dietary intake', 'intervention group (IG), control group (CG', 'fruits and vegetables (F&V']","['knowledge regarding portion sizes', 'Intake of fruits, vegetables and juices', 'fruit and vegetable consumption', 'knowledge regarding portion sizes of F&V and daily intake of fruits and vegetables']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2.0,0.0190335,There was a significant increase (p=0.002) in contemplation and preparation stage (13-34%) in IG after intervention.,"[{'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Subitha', 'Initials': 'S', 'LastName': 'Lakshminarayanan', 'Affiliation': 'Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Jeby Jose', 'Initials': 'JJ', 'LastName': 'Olickal', 'Affiliation': 'Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2020-0077']
2637,32845864,Efficacy of Habbul aas (fruits of Myrtus communis) in menorrhagia: a single blinded randomized standard control study.,"Objectives Menorrhagia can be defined as heavy uterine bleeding which comes at regular intervals or uterine bleeding extending more than seven days during menses which has become a considerable problem for females, causing discomfort, anxiety, and poor quality of life. In this study we aimed to compare the effect of Myrtus communis fruits with tranexamic acid in the treatment of menorrhagia. Methods In this prospective patient blinded standard controlled study, 40 patients of menorrhagia were randomly assigned to receive either test drug (powdered M. communis fruits) or active control drug (tranexamic acid) for first five days of menstrual cycle consecutively for two cycles. The primary outcome measure was reduction in heavy flow during menses determined by pictorial blood loss assessment chart (PBAC), while improvements in quality of life (QOL) by using short form-36 questionnaire and increase in hemoglobin percentage were kept as secondary outcome measures. Results Both the groups were similar at baseline. Test and control drugs significantly reduced the PBAC score during treatment cycles with p-value <0.001 and these changes were not significantly different between the groups. During second treatment cycle significant difference was found in PBAC score (p = 0.024) between the groups. After treatment significant improvement in hemoglobin percentage was noted and marked improvement in overall quality of life was observed in both the groups. Conclusion These data suggest that M. communis fruits can be an effective alternate in reducing heavy menstrual bleeding. There is need to confirm these results by designing a trial on large number of patients. Trial Registration No CTRI/2017/09/009937.",2020,During second treatment cycle significant difference was found in PBAC score (p = 0.024) between the groups.,"['menorrhagia', '40 patients of menorrhagia']","['test drug (powdered M. communis fruits) or active control drug (tranexamic acid', 'Habbul aas (fruits of Myrtus communis', 'Myrtus communis fruits with tranexamic acid']","['PBAC score', 'overall quality of life', 'reduction in heavy flow during menses determined by pictorial blood loss assessment chart (PBAC), while improvements in quality of life (QOL) by using short form-36 questionnaire and increase in hemoglobin percentage', 'hemoglobin percentage', 'heavy menstrual bleeding']","[{'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0175701', 'cui_str': 'Aarskog syndrome'}, {'cui': 'C3853725', 'cui_str': 'Myrtus communis whole extract'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}]",40.0,0.168523,During second treatment cycle significant difference was found in PBAC score (p = 0.024) between the groups.,"[{'ForeName': 'Rayeesa Banu R', 'Initials': 'RBR', 'LastName': 'Umarami', 'Affiliation': 'Dept. of Niswan wa Qabala, Luqman Unani Medical College Hospital and Research Centre, Naubag, Vijayapur, Karnataka, India.'}, {'ForeName': 'Mariyam', 'Initials': 'M', 'LastName': 'Roqaiya', 'Affiliation': 'Dept. of Niswan wa Qabala, Luqman Unani Medical College Hospital and Research Centre, Naubag, Vijayapur, Karnataka, India.'}, {'ForeName': 'Mohd Aqil', 'Initials': 'MA', 'LastName': 'Quadri', 'Affiliation': 'Dept. of Niswan wa Qabala, Luqman Unani Medical College Hospital and Research Centre, Naubag, Vijayapur, Karnataka, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2018-0235']
2638,32845892,"Are gamers better laparoscopic surgeons? Impact of gaming skills on laparoscopic performance in ""Generation Y"" students.","BACKGROUND


Both laparoscopic surgery and computer games make similar demands on eye-hand coordination and visuospatial cognitive ability. A possible connection between both areas could be used for the recruitment and training of future surgery residents.
AIM


The goal of this study was to investigate whether gaming skills are associated with better laparoscopic performance in medical students.
METHODS


135 medical students (55 males, 80 females) participated in an experimental study. Students completed three laparoscopic tasks (rope pass, paper cut, and peg transfer) and played two custom-designed video games (2D and 3D game) that had been previously validated in a group of casual and professional gamers.
RESULTS


There was a small significant correlation between performance on the rope pass task and the 3D game, Kendall's τ(111) = -.151, P = .019. There was also a small significant correlation between the paper cut task and points in the 2D game, Kendall's τ(102) = -.180, P = .008. Overall laparoscopic performance was also significantly correlated with both the 3D game, Kendall's τ(112) = -.134, P = .036, and points in the 2D game, Kendall's τ(113) = -.163, P = .011. However, there was no significant correlation between the peg transfer task and both games (2D and 3D game), P = n.s..
CONCLUSION


This study provides further evidence that gaming skills may be an advantage when learning laparoscopic surgery.",2020,"However, there was no significant correlation between the peg transfer task and both games (2D and 3D game), P = n.s..
CONCLUSION


","['Generation Y"" students', '135 medical students (55 males, 80 females) participated in an experimental study', 'medical students']","['laparoscopic surgery and computer games', 'gaming skills', 'laparoscopic tasks (rope pass, paper cut, and peg transfer) and played two custom-designed video games (2D and 3D game) that had been previously validated in a group of casual and professional gamers']","['laparoscopic performance', 'Overall laparoscopic performance', 'peg transfer task and both games (2D and 3D game']","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",135.0,0.0892581,"However, there was no significant correlation between the peg transfer task and both games (2D and 3D game), P = n.s..
CONCLUSION


","[{'ForeName': 'Rabi', 'Initials': 'R', 'LastName': 'Datta', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Seung-Hun', 'Initials': 'SH', 'LastName': 'Chon', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dratsch', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Timmermann', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Patrick Sven', 'Initials': 'PS', 'LastName': 'Plum', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Haneder', 'Affiliation': 'Institute of Diagnostic and Interventional Radiology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pinto Dos Santos', 'Affiliation': 'Institute of Diagnostic and Interventional Radiology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin Richard', 'Initials': 'MR', 'LastName': 'Späth', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Wahba', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane Josephine', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kleinert', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0232341']
2639,32845968,Long-term change in physiological markers and cognitive performance in type 2 diabetes: the Look AHEAD Study.,"CONTEXT


The effects of physiological improvements on cognitive function among persons with type 2 diabetes mellitus (T2DM) are not fully understood.
OBJECTIVE


To determine whether improvements in physiological markers (body weight, blood sugar control, and physical activity) during intensive lifestyle intervention (ILI) are associated with enhancements in cognitive function in older adults with T2DM.
DESIGN


Multi-site randomized controlled trial.
SETTING


Academic research centers.
PATIENTS OR OTHER PARTICIPANTS


Participants were aged 45-76 years with T2DM.
INTERVENTION


The Action for Health in Diabetes (Look AHEAD) study, a randomized controlled clinical trial of ILI.
MAIN OUTCOME MEASURE


Two to three cognitive assessments were collected from 1089 participants, the first and last occurring a mean [standard deviation] of 8.6 [1.0] and 11.5 [.7] years after enrollment.
RESULTS


Greater improvements in blood sugar control were associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC: p=.0360, HbA1C and DSC: p=.0477) , but weight loss had mixed associations with cognitive scores (greater BMI reduction and worse AVLT overall: p=.0053; greater BMI reduction and better DSC scores among those overweight but not obese at baseline: p=.010). Associations were strongest among those who were overweight (not obese) at baseline; and among those with a history of cardiovascular disease (CVD) at baseline.
CONCLUSIONS


Improvements in glycemic control, but not necessarily weight status, during ILI may be associated with better subsequent cognitive performance. These associations may differ by adiposity and CVD history.",2020,"RESULTS


Greater improvements in blood sugar control were associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC:","['persons with type 2 diabetes mellitus (T2DM', 'Diabetes', 'Academic research centers', 'type 2 diabetes', 'Participants were aged 45-76 years with T2DM', '1089 participants, the first and last occurring a mean [standard deviation] of 8.6 [1.0] and 11.5 [.7', 'older adults with T2DM']","['HbA1C and DSC', 'intensive lifestyle intervention (ILI']","['BMI reduction and better DSC scores', 'blood sugar control', 'physiological markers and cognitive performance', 'cognitive function', 'cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC', 'physiological markers (body weight, blood sugar control, and physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",1089.0,0.0476723,"RESULTS


Greater improvements in blood sugar control were associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC:","[{'ForeName': 'Owen T', 'Initials': 'OT', 'LastName': 'Carmichael', 'Affiliation': ''}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Wake Forest University School of Medicine.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hayden', 'Affiliation': 'Wake Forest University School of Medicine.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'University of Tennessee Health Science Center.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Wake Forest University School of Medicine.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Johns Hopkins University.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Wake Forest University School of Medicine.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa591']
2640,32845964,Will the SPYRAL-OFF MED pivotal trial switch our interest in renal denervation back on?,,2020,,[],[],[],[],[],[],,0.0199842,,"[{'ForeName': 'Giovanni Luigi', 'Initials': 'GL', 'LastName': 'De Maria', 'Affiliation': 'Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Headley Way, OX3 9DU Oxford, UK.'}]",Cardiovascular research,['10.1093/cvr/cvaa203']
2641,32846174,Heart rate variability in healthy young adults exposed to global system for mobile communication (GSM) 900-MHz radiofrequency signal from mobile phones.,"Given the large number of mobile phone users and the increasing exposure to radiofrequency electromagnetic field (RF-EMF) worldwide, we aimed to study the effect of RF-EMF related to mobile phones on heart rate variability (HRV). Twenty-six healthy young adults participated in two experimental sessions with a double-blind, randomized and counter-balanced crossover design. During each session, participants were exposed for 26 minutes to a sham or real 900 MHz RF-EMF, generated by a commercial dual-band Global System for Mobile technology (GSM) mobile phone. We recorded an electrocardiogram at rest during the exposure. We evaluated HRV by time- and frequency-domain analysis. Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure. Other time-domain parameters were not affected. Analysis in the frequency-domain demonstrated that total spectral power and low-frequency band (LF) absolute power were significantly increased during exposure (p = .046 and p = .043, respectively). However, other parameters were not affected. In conclusion, it seems that most HRV parameters were not affected by GSM signal exposure in our study. The weak effect observed on HRV frequency-domain is likely to represent a random occurrence rather than a real effect.",2020,Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure.,"['healthy young adults', 'Twenty-six healthy young adults']","['RF-EMF', 'global system for mobile communication (GSM) 900-MHz radiofrequency signal from mobile phones', 'sham or real 900 MHz RF-EMF, generated by a commercial dual-band Global System for Mobile technology (GSM) mobile phone']","['Heart rate variability', 'heart rate variability (HRV', 'total spectral power and low-frequency band (LF) absolute power', 'standard deviation of interbeat intervals (SDNN']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175723', 'cui_str': 'Band'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",26.0,0.0704992,Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure.,"[{'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Wallace', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550 Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025 Amiens, France. Electronic address: brahim.selmaoui@ineris.fr.""}, {'ForeName': 'Soafara', 'Initials': 'S', 'LastName': 'Andrianome', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550 Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025 Amiens, France.""}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Ghosn', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550 Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025 Amiens, France.""}, {'ForeName': 'Erwan Stephan', 'Initials': 'ES', 'LastName': 'Blanchard', 'Affiliation': 'PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025 Amiens, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Telliez', 'Affiliation': 'PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025 Amiens, France.'}, {'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Selmaoui', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550 Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025 Amiens, France.""}]",Environmental research,['10.1016/j.envres.2020.110097']
2642,32846766,Comparison of tendon suture fixation and cortical screw fixation for treatment of distal tibiofibular syndesmosis injury: A case-control study.,"This study aimed to investigate the effectiveness of tendon suture fixation versus cortical screw fixation for the treatment of distal tibiofibular syndesmosis injury.This study recruited 42 patients with Danis-Weber type B, C1 and C2 fractures concomitant with lower tibiofibular syndesmosis injury, who were randomly assigned to 2 groups according to treatment with cortical screw fixation (n = 21) and tendon suture fixation (n = 21). Operation time, intraoperative blood loss, time to full weight-bearing activity, medical cost, ankle function, and ankle pain were compared between the 2 groups.The operation time was significantly less with cortical screw fixation (57.1 ± 5.3 min) than with tendon suture fixation (63.3 ± 6.3 min; p = 0.01), but there was no significant difference in intraoperative blood loss. The time until full weight-bearing was possible was significantly longer after cortical screw fixation (10.9 ± 2.7 weeks) than after tendon suture fixation (7.1 ± 1.9 weeks; P < .001). The medical cost was much greater for cortical screw fixation (1861.6 ± 187.3 USD) than for tendon suture fixation (1209.6 ± 97.6 USD; P < .01). The rate of excellent and good ankle function at 3 months after surgery was significantly higher with tendon suture fixation (71.4%) than with cortical screw fixation (33.3%; P = .03).Tendon suture fixation is associated with quicker recovery of ankle function, shorter time to full weight-bearing, and lower medical cost to the patient compared with screw fixation. Our findings suggest that tendon suture fixation is an effective method for the treatment of tibiofibular syndesmosis injury.",2020,"suture fixation is associated with quicker recovery of ankle function, shorter time to full weight-bearing, and lower medical cost to the patient compared with screw fixation.","['distal tibiofibular syndesmosis injury', '42 patients with Danis-Weber type B, C1 and C2 fractures concomitant with lower tibiofibular syndesmosis injury']","['tendon suture fixation and cortical screw fixation', '03).Tendon', 'suture fixation', 'tendon suture fixation versus cortical screw fixation', 'cortical screw fixation', 'cortical screw fixation (n\u200a=\u200a21) and tendon suture fixation', 'tendon suture fixation']","['rate of excellent and good ankle function', 'Operation time, intraoperative blood loss, time to full weight-bearing activity, medical cost, ankle function, and ankle pain', 'medical cost', 'intraoperative blood loss', 'time until full weight-bearing', 'operation time', 'cortical screw fixation']","[{'cui': 'C0730182', 'cui_str': 'Distal tibiofibular joint structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582525', 'cui_str': 'weber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0730180', 'cui_str': 'Tibiofibular joint structure'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0238656', 'cui_str': 'Ankle pain'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",42.0,0.0263796,"suture fixation is associated with quicker recovery of ankle function, shorter time to full weight-bearing, and lower medical cost to the patient compared with screw fixation.","[{'ForeName': 'Liuhong', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Zhifu', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': ''}, {'ForeName': 'Zhongqiang', 'Initials': 'Z', 'LastName': 'Kuang', 'Affiliation': ''}, {'ForeName': 'Shiyan', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Fang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021573']
2643,32846806,"Efficacy of nasal high flow therapy on the coordination between breathing and swallowing of saliva during daytime nap in chronic obstructive pulmonary disease patients: A single center, randomized crossover controlled study.","BACKGROUND


There are some clinical reports on dysphagia in patients with chronic obstructive pulmonary disease (COPD); however, its pathophysiology remains largely unknown.Changes in respiratory function occur in patients with COPD causing a decrease in tidal volume and an increase in respiratory rate (tachypnea). In addition, it leads to lack of coordination between respiration and swallowing.A new treatment called nasal high flow (NHF) has been introduced for patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure. The NHF therapy involves inhalation of high flow of humidified air, which reduces respiratory effort in patients with COPD. Furthermore, NHF therapy facilitates swallowing of saliva even during respiratory management. A recent clinical study reported that high-flow nasal cannula oxygen therapy for 6 weeks improved the health-related quality of life and reduced hypercapnia in patients with stable COPD. Taken together, NHF therapy is gaining attention in the clinical management of patients with COPD.Therefore, in this study, we aim to examine the efficacy of NHF therapy on the coordination between breathing and swallowing of saliva during daytime nap in patients with COPD.
METHODS/DESIGN


This open-label, investigator-initiated, single center study will evaluate the efficacy of NHF therapy on the coordination between breathing and swallowing of saliva during the daytime nap in COPD patients with forced expiratory volume in 1 second (FEV1%) of <70% during treatment at the Nagasaki University Hospital Respiratory Rehabilitation Center. Evaluations will be performed during the 90 to 180 minute ""daytime nap"" in the measurement room of the hospital. The primary endpoint will be the rate of appearance of the expiratory phase after swallowing of saliva and the frequency of swallowing during the measurement period.
DISCUSSION


The purpose of this study is to obtain evidence regarding the utility of NHF as a potential therapeutic device for COPD patients to prevent aspiration of saliva during the sleep stage of daytime nap. The utility will be assessed by comparing the decrease in incidence rates of the expiratory phase after swallowing of saliva in the NHF device group and the control group, wherein this device was not used.",2020,"A new treatment called nasal high flow (NHF) has been introduced for patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure.","['patients with chronic obstructive pulmonary disease (COPD', 'COPD patients with forced expiratory volume in 1\u200asecond (FEV1%) of <70% during treatment at the Nagasaki University Hospital Respiratory Rehabilitation Center', 'patients with COPD', 'patients with stable COPD', 'COPD patients to prevent aspiration of saliva during the sleep stage of daytime nap', 'chronic obstructive pulmonary disease patients', 'patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure']","['nasal high flow therapy', 'NHF therapy', 'NHF']","['coordination between breathing and swallowing of saliva', 'respiratory rate (tachypnea', 'rate of appearance of the expiratory phase after swallowing of saliva and the frequency of swallowing during the measurement period', 'tidal volume', 'health-related quality of life and reduced hypercapnia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0429933', 'cui_str': 'Measurement period'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]",,0.0371154,"A new treatment called nasal high flow (NHF) has been introduced for patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure.","[{'ForeName': 'Terumi', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Hisamatsu', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tamada', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher & Paykel Healthcare Ltd., Auckland, New Zealand.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher & Paykel Healthcare Ltd., Auckland, New Zealand.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Takahata', 'Affiliation': 'Department of Rehabilitation Medicine, Nagasaki University Hospital.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Special Care Dentistry.'}]",Medicine,['10.1097/MD.0000000000021778']
2644,32846821,Effect and safety of intravenous versus oral acetaminophen after unicompartmental knee replacement: A protocol of randomized controlled study.,"BACKGROUND


Due to the soft tissue injury and large amount of bone destruction involved, undesirable postoperative pain remains a challenge for both patients and surgeons after unicompartmental knee replacement (UKR). However, there are no studies comparing the effectiveness of oral and intravenous acetaminophen as part of a standard multimodal perioperative pain regimen after UKR. Thus, this prospective randomized study was conducted to compare pain control outcomes with postoperative oral versus intravenous acetaminophen use in adults undergoing UKR.
METHODS


The institutional review board of the Traditional Chinese Medicine- western Medicine Hospital of Cangzhou approved the study protocol. This blinded and randomized study was carried out in accordance with the principles of the Helsinki Declaration. We included patients who were scheduled for UKR with an American Society of Anesthesiologists status of I to III, who were mentally competent, and who were able to give consent for enrolment in the study. Patients were randomly assigned on a 1:1 basis to receive either intravenous acetaminophen or oral acetaminophen. We ensured that the patients, care providers, and outcome assessors were blinded to the group assignment during the study period. Primary outcomes were postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score. Secondary outcomes included morphine consumption at 24, 48, and 72 hours after surgery, length of hospital stay, range of motion, daily ambulation distance, and adverse events occurrence. All statistical analyses were performed using SPSS 25.0. Differences associated with a P value of <.05 were considered statistically significant.
RESULTS


It was hypothesized that patients receiving intravenous acetaminophen would exhibit similar postoperative outcomes compared with patients receiving oral acetaminophen.
TRIAL REGISTRATION


This study was registered in Research Registry (researchregistry5825).",2020,Primary outcomes were postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score.,"['unicompartmental knee replacement', 'patients and surgeons after unicompartmental knee replacement (UKR', 'patients who were scheduled for UKR with an American Society of Anesthesiologists status of I to III, who were mentally competent, and who were able to give consent for enrolment in the study', 'adults undergoing UKR']","['acetaminophen', 'oral acetaminophen', 'postoperative oral versus intravenous acetaminophen', 'acetaminophen or oral acetaminophen']","['postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score', 'pain control outcomes', 'morphine consumption at 24, 48, and 72\u200ahours after surgery, length of hospital stay, range of motion, daily ambulation distance, and adverse events occurrence']","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.0892136,Primary outcomes were postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score.,"[{'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Hengjun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021816']
2645,32846841,The efficacy of bidirectional barbed sutures for incision closure in total knee replacement: A protocol of randomized controlled trial.,"BACKGROUND


Barbed suture is a novel type of suture introduced in different surgical specialties. Nevertheless, its effect in total knee replacement is still unclear in terms of wound complications and cost effectiveness. The purpose of the present work is to evaluate the safety and efficacy of bidirectional barbed suture in reducing postoperative wound complications in the patients undergoing total knee replacement.
METHODS


This prospective, randomized, and controlled study was performed from January 2017 to December 2018. It was authorized via institutional review committee of Yuebei People's Hospital (GDYB1002189). Hundred participants were divided randomly into 2 groups, namely, control group (n = 50) and the study group (n = 50), respectively. All operations were performed using the Miller-Galante prosthesis (Zimmer; Warsaw, IN). For study groups, the joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture. At the end, extra 4 to 5 stitches were made to avoid detachment and incision rupture. For control group: the joint capsule was sutured by a traditional absorbable suture (Ethicon VICRYL* Plus 1-0), and the subcutaneous tissue was sutured by an absorbable suture (Ethicon VICRYL* Plus 2-0). The skin was sutured by staples. Incision length, suture time, operation time, postoperative length of hospital stay, and incision complications (such as effusion, infection, hematoma, and skin necrosis) were recorded. All data analyses are implemented through utilizing SPSS for Windows Version 20.0.
RESULTS


The results will be shown in Table 1.
CONCLUSION


This study can reach a reliable evidence for utilizing bidirectional barbed suture in wound closure in total knee replacement.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5823).",2020,"For study groups, the joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture.","['Hundred participants', 'total knee replacement', 'January 2017 to December 2018', 'patients undergoing total knee replacement']","['bidirectional barbed suture', 'joint capsule was sutured by a traditional absorbable suture (Ethicon VICRYL* Plus 1-0), and the subcutaneous tissue was sutured by an absorbable suture', 'joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture', 'bidirectional barbed sutures']","['safety and efficacy', 'Incision length, suture time, operation time, postoperative length of hospital stay, and incision complications (such as effusion, infection, hematoma, and skin necrosis']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0151799', 'cui_str': 'Skin necrosis'}]",0.0,0.0572576,"For study groups, the joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture.","[{'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Orthopedics, Yuebei People's Hospital, Shaoguan, Guangdong, China.""}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xi', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021867']
2646,32846929,A Traditional Korean Diet Alters the Expression of Circulating MicroRNAs Linked to Diabetes Mellitus in a Pilot Trial.,"The traditional Korean diet (K-diet) is considered to be healthy and circulating microRNAs (miRs) have been proposed as useful markers or targets in diet therapy. We, therefore, investigated the metabolic influence of the K-diet by evaluating the expression of plasma and salivary miRs. Ten women aged 50 to 60 years were divided into either a K-diet or control diet (a Westernized Korean diet) group. Subjects were housed in a metabolic unit-like condition during the two-week dietary intervention. Blood and saliva samples were collected before and after the intervention, and changes in circulating miRs were screened by an miR array and validated by individual RT-qPCRs. In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05). Among five down-regulated salivary miRs, hsa-miR-92-3p and hsa-miR-122a-5p were validated, which are associated with diabetes mellitus, acute coronary syndrome and non-alcoholic fatty liver disease. In the control diet group, validated were down-regulated plasma hsa-miR-25-3p and salivary hsa-miR-31-5p, which are associated with diabetes mellitus, adipogenesis and obesity. The K-diet may influence the metabolic conditions associated with diabetes mellitus, as evidenced by changes in circulating miRs, putative biomarkers for K-diet.",2020,"In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05).",['Ten women aged 50 to 60 years'],"['K-diet or control diet (a Westernized Korean diet', 'traditional Korean diet (K-diet']","['Blood and saliva samples', 'eight plasma miRs', 'Expression of Circulating MicroRNAs']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}]",10.0,0.0120408,"In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05).","[{'ForeName': 'Phil-Kyung', 'Initials': 'PK', 'LastName': 'Shin', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Myung Sunny', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Seon-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Hye Jeong', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Soon-Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'KyongChol', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Healthy Aging, GangNam Major Hospital, Seoul 06279, Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Sang-Woon', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}]",Nutrients,['10.3390/nu12092558']
2647,32847273,"Universal and targeted computerised cognitive behavioural therapy (Think, Feel, Do) for emotional health in schools: results from two exploratory studies.","BACKGROUND


Computerised Cognitive Behaviour Therapy (cCBT) offers the potential to make evidence based interventions more available and accessible for children and young people. Research is currently limited and proof of concept studies are required to explore the viability and possible therapeutic benefits of cCBT as a universal or targeted intervention in schools.
METHOD


In Study 1, cCBT was provided as a universal intervention to 13 participants who were assigned to either group cCBT or a matched computer gaming condition. In Study 2, cCBT was provided as a targeted intervention by trained school nurses to 12 participants with mild or moderate emotional problems.
RESULTS


Both studies found cCBT to result in immediate post intervention benefits and feedback about the programme was very positive.
CONCLUSION


This study provides proof of concept that cCBT provided as a universal or targeted emotional health intervention in schools is viable and may result in immediate therapeutic benefits. These findings are limited by the small sample size and absence of follow-up but suggest that more methodologically robust evaluations should be pursued.",2012,This study provides proof of concept that cCBT provided as a universal or targeted emotional health intervention in schools is viable and may result in immediate therapeutic benefits.,"['children and young people', 'emotional health in schools', '12 participants with mild or moderate emotional problems', '13 participants who were assigned to either group']","['cCBT or a matched computer gaming condition', 'Universal and targeted computerised cognitive behavioural therapy', 'Computerised Cognitive Behaviour Therapy (cCBT', 'cCBT']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}]",[],13.0,0.0555287,This study provides proof of concept that cCBT provided as a universal or targeted emotional health intervention in schools is viable and may result in immediate therapeutic benefits.,"[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Attwood', 'Affiliation': 'Graduate School of Education, 35 Berkeley Square, University of Bristol, Bristol BS8 1JA, UK. E-mail: attwoodmegan@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Meadows', 'Affiliation': 'Graduate School of Education, 35 Berkeley Square, University of Bristol, Bristol BS8 1JA, UK. E-mail: attwoodmegan@gmail.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stallard', 'Affiliation': 'Department for Health, 22-23 Eastwood, University of Bath, Bath BA2 7AY, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Richardson', 'Affiliation': 'Department for Health, 22-23 Eastwood, University of Bath, Bath BA2 7AY, UK.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2011.00627.x']
2648,32847314,Innovations in Practice: Preliminary evidence for effective family engagement in treatment for child traumatic stress-trauma systems therapy approach to preventing dropout.,"BACKGROUND


This study aimed to obtain preliminary evidence for the extent to which a novel intervention embedded within a systems-oriented treatment model [trauma systems therapy (TST)] engages and retains traumatized children and their families in treatment.
METHOD


Twenty youth who had prominent symptoms of posttraumatic stress were randomly assigned to receive TST or care as usual (CAU).
RESULTS


At the 3-month assessment, 90% of TST participants were still in treatment, whereas only 10% of CAU participants remained. Within-group analyses of TST participants demonstrated significant reductions in posttraumatic stress and aggression as well as a slight improvement in home safety.
CONCLUSIONS


These preliminary findings point to the need to utilize effective engagement approaches to retain traumatized children and their families in treatment.",2012,"Within-group analyses of TST participants demonstrated significant reductions in posttraumatic stress and aggression as well as a slight improvement in home safety.
",['Twenty youth who had prominent symptoms of posttraumatic stress'],"['novel intervention embedded within a systems-oriented treatment model [trauma systems therapy (TST', 'TST', 'TST or care as usual (CAU']","['home safety', 'posttraumatic stress and aggression']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",,0.0233415,"Within-group analyses of TST participants demonstrated significant reductions in posttraumatic stress and aggression as well as a slight improvement in home safety.
","[{'ForeName': 'Glenn N', 'Initials': 'GN', 'LastName': 'Saxe', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Heidi Ellis', 'Affiliation': ""Children's Hospital Boston/Harvard Medical School, Boston, MA, USA. E-mail: carryl.navalta@childrens.harvard.edu.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fogler', 'Affiliation': 'The Counseling Center of Nashua, Nashua, NH, USA.'}, {'ForeName': 'Carryl P', 'Initials': 'CP', 'LastName': 'Navalta', 'Affiliation': ""Children's Hospital Boston/Harvard Medical School, Boston, MA, USA. E-mail: carryl.navalta@childrens.harvard.edu.""}]",Child and adolescent mental health,['10.1111/j.1475-3588.2011.00626.x']
2649,32847320,[Safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention].,"Objective:  To compare the safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention(PCI) in real-world.  Methods:  A total of 13 097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study. Patients were stratified as the bivalirudin group or the heparin group according to antithrombotic therapy during PCI. The primary efficiency endpoint was 30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, urgent target lesion revascularization (uTLR), stroke or any bleeding. The second efficiency endpoint was 30-day major cardiac and cerebral events (MACCE), defined as all-cause death, re-infarction, uTLR and stroke. Additional end points included the rates of stent thrombosis at 30 days. Propensity scores included clinical and demographic variables, with 1∶2 matching. Compared the incidence of events above between the two groups before and after matching.  Results:  Among the 13 097 included patients(age was (61±10) years old), 3 421 (26.1%) were female. And 2 734 patients were divided into the bivalirudin group, and 10 363 patients to the heparin group(5 468 after matching). Before propensity score matching, patients in bivalirudin group were older and received higher levels of CRUSADE score than heparin group. These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all  P ＜0.05）. After propensity score matching, the incidence of 30-day NACE(3.8%(103/2 734) vs.5.0%(271/5 468),  P =0.015) and any bleeding (2.0%(54/2 734) vs. 2.8%(151/5 468),  P =0.032) in the bivalirudin group were lower than that in the heparin group, but the incidence of MACCE (1.9%(51/2 734) vs. 2.3%(127/5 468),  P =0.180) and stent thrombosis (0.1%(2/2 734) vs. 0.1%(3/5 468),  P =1.000) were comparable between the two groups.  Conclusion:  The risk of bleeding and the incidence of NACE are significantly lower for patients using bivalirudin during perioperative period of PCI compared to heparin, without significant differences in ischemic events.",2020,These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all  P ＜0.05）.,"['And 2 734 patients', '13 097 included patients(age was (61±10) years old), 3 421 (26.1%) were female', 'A total of 13 097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study', 'group, and 10 363 patients to the']","['antithrombotic therapy', 'heparin', 'bivalirudin', 'unfractionated heparin']","['30-day major cardiac and cerebral events (MACCE), defined as all-cause death, re-infarction, uTLR and stroke', 'safety and efficacy', 'rates of stent thrombosis', 'risk of bleeding and the incidence of NACE', 'stent thrombosis', 'ischemic events', '30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, urgent target lesion revascularization (uTLR), stroke or any bleeding', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",13097.0,0.0307312,These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all  P ＜0.05）.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'Z Y', 'Initials': 'ZY', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}]",Zhonghua xin xue guan bing za zhi,['10.3760/cma.j.cn112148-20200717-00566']
2650,32847382,Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial.,"BACKGROUND


Echo-guided percutaneous procedures have been reported reliable and advantageous. However, the learning curve is difficult for junior doctors. We aimed to evaluate the safety and efficacy of a novel guidewire (Panna wire) in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only.
METHODS


The Panna wire is designed for echo-guide procedure with a retractable spindle-shaped tip. A multicenter, randomized, controlled trial was conducted to evaluate the safety and efficacy of the Panna wire versus the conventional guidewire for junior doctors with <100 cases experience. The primary outcome was operative success rate. The secondary outcomes were incidence of major adverse events, operation time, time needed to enter the left atrium, number of arrhythmia episodes, number of misguidance to tricuspid valve, and incidence of peripheral vascular complications.
RESULTS


Between July 2018 and September 2019, 100 patients with atrial septal defect were randomized to either the Panna wire group (n=52) or the conventional wire group (n=48) at 3 centers. The baseline clinical characteristics were similarly distributed. The operative success rate (primary outcome) was 100% in the Panna wire group versus 68.75% in the conventional wire group ( P <0.001). No major adverse events occurred in either group. Significant differences in favor of the Panna wire group were found in operation time ( P =0.004), time needed to enter the left atrium ( P <0.001), number of arrhythmia episodes ( P <0.001), and number of misguidance to tricuspid valve ( P =0.005).
CONCLUSIONS


The Panna wire is safe and effective and reduces the learning curve in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT04096924.",2020,"Significant differences in favor of the Panna wire group were found in operation time ( P =0.004), time needed to enter the left atrium ( P <0.001), number of arrhythmia episodes ( P <0.001), and number of misguidance to tricuspid valve ( P =0.005).
","['junior doctors with <100 cases experience', 'Between July 2018 and September 2019', 'Atrial Septal Defect Closure', '100 patients with atrial septal defect']","['conventional wire group', 'Panna wire group', 'novel guidewire (Panna wire', 'Panna wire versus the conventional guidewire', 'Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure']","['number of misguidance to tricuspid valve', 'safety and efficacy', 'operative success rate', 'adverse events', 'time needed to enter the left atrium', 'operation time', 'number of arrhythmia episodes', 'incidence of major adverse events, operation time, time needed to enter the left atrium, number of arrhythmia episodes, number of misguidance to tricuspid valve, and incidence of peripheral vascular complications']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040960', 'cui_str': 'Tricuspid valve structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0225860', 'cui_str': 'Left atrial structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0161817', 'cui_str': 'Peripheral vascular complication'}]",100.0,0.135079,"Significant differences in favor of the Panna wire group were found in operation time ( P =0.004), time needed to enter the left atrium ( P <0.001), number of arrhythmia episodes ( P <0.001), and number of misguidance to tricuspid valve ( P =0.005).
","[{'ForeName': 'Pengxu', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.).'}, {'ForeName': 'Guangzhi', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.).'}, {'ForeName': 'Zonggang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiac Surgery, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (Z.Z., W.Z.).""}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiac Surgery, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (Z.Z., W.Z.).""}, {'ForeName': 'Taibing', 'Initials': 'T', 'LastName': 'Fan', 'Affiliation': ""Department of Cardiovascular Surgery, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, China (T.F., Y.H.).""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Cardiovascular Surgery, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, China (T.F., Y.H.).""}, {'ForeName': 'Kunjing', 'Initials': 'K', 'LastName': 'Pang', 'Affiliation': 'Department of Echocardiography, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China. (K.P.).'}, {'ForeName': 'Shouzheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.).'}, {'ForeName': 'Fengwen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.).'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Biomaterial Research, Institute of Biomedical Engineering, Chinese Academy of Medical Sciences and Peking Union Medical College, China (W.W.).'}, {'ForeName': 'Shengshou', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.).'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009281']
2651,32847453,Effect of hybrid teaching incorporating problem-based learning on student performance in pathophysiology.,"OBJECTIVE


To compare the effectiveness of traditional and hybrid teaching strategies in pathophysiology and to conduct a survey of students' opinions about the hybrid teaching strategy.
METHODS


A hybrid pathophysiology course was developed by combining traditional lectures, case- or problem-based learning, group discussion and several quizzes. A total of 167 students were assigned to the hybrid teaching group and 118 students assigned to the traditional lecture group.
RESULTS


Compared with students who received traditional lectures, no students in the hybrid teaching class failed the final examination. The percentage of students with high scores was significantly higher in the hybrid teaching class. In addition, 73.7% of students in the hybrid teaching class expressed substantial interest in pathophysiology during the course, and 83% of these students felt they had received essential training and acquired the ability to solve clinical case problems.
CONCLUSION


The hybrid teaching strategy is an advanced approach that encourages students to actively learn teaching materials and solve practical clinical problems, and that promotes student interest in pathophysiology.",2020,The percentage of students with high scores was significantly higher in the hybrid teaching class.,['A total of 167 students were assigned to the hybrid teaching group and 118 students assigned to the'],"['traditional and hybrid teaching strategies', 'traditional lecture group', 'hybrid teaching incorporating problem-based learning']",['percentage of students with high scores'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",167.0,0.0183439,The percentage of students with high scores was significantly higher in the hybrid teaching class.,"[{'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Haolin', 'Initials': 'H', 'LastName': 'Bu', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiaqing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiangying', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}]",The Journal of international medical research,['10.1177/0300060520949402']
2652,32847461,"Efficacy of Omega-3 and Korean Red Ginseng in Children with Subthreshold ADHD: A Double-Blind, Randomized, Placebo-Controlled Trial.","OBJECTIVE


The purpose of the present study was to investigate the efficacy of combined omega-3 and Korean red ginseng supplementation on ADHD symptoms and cognitive function in children with subthreshold ADHD.
METHOD


120 children from 6 to 12 years with subthreshold ADHD were enrolled in this 12-week, double-blind, randomized, placebocontrolled study. The primary outcome was measured by Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS). Children Behavior Check List (CBCL), and neuropsychological tests assessing attention, memory, and executive function were included as secondary primary outcome measures.
RESULTS


Significant effects on the scores of ADHDRS, as well as several subscales of CBCL including ADHD and attention problem subscales were revealed.
CONCLUSION


The combination of omega-3 and Korean red ginseng may have beneficial effects in children with subthreshold ADHD. Increased clinical awareness of ADHD symptoms even at a subthreshold level is needed.",2020,"RESULTS


Significant effects on the scores of ADHDRS, as well as several subscales of CBCL including ADHD and attention problem subscales were revealed.
","['children with subthreshold ADHD', 'Children with Subthreshold ADHD', '120 children from 6 to 12\u2009years with subthreshold ADHD']","['omega-3 and Korean red ginseng', 'combined omega-3 and Korean red ginseng supplementation', 'Placebo', 'Omega-3 and Korean Red Ginseng']","['Children Behavior Check List (CBCL), and neuropsychological tests assessing attention, memory, and executive function', 'several subscales of CBCL including ADHD and attention problem subscales', 'Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS', 'scores of ADHDRS', 'ADHD symptoms and cognitive function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",120.0,0.324192,"RESULTS


Significant effects on the scores of ADHDRS, as well as several subscales of CBCL including ADHD and attention problem subscales were revealed.
","[{'ForeName': 'Jeewon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon-Si, Gyeonggi-Do, Republic of Korea.'}, {'ForeName': 'Soyoung Irene', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon-Si, Gyeonggi-Do, Republic of Korea.'}]",Journal of attention disorders,['10.1177/1087054720951868']
2653,32847466,Cost analysis of home telerehabilitation for speech treatment in people with Parkinson's disease.,"INTRODUCTION


Geographical barriers and impaired physical mobility among people with Parkinson's disease (PD) hinder their timely access to speech pathology services. We compared the costs of delivering a speech treatment via in-person consultation versus telerehabilitation.
METHODS


We used data from a non-inferiority randomised controlled trial delivering the Lee Silverman Voice Treatment (LSVT LOUD®), where patients with dysarthria associated with PD were assigned to either the urban in-person group ( N  = 16) or the urban online group ( N  = 15), supplemented with a non-randomised group (regional online;  N  = 21). We compared costs over a one-month treatment period from a health-system perspective and a patient perspective.
RESULTS


The mean treatment costs of both urban online ($1076) and regional ($1206) treatments tended to be slightly higher than urban in-person ($1020) from a health-system perspective. From a patient perspective, the mean treatment cost was $831 in the urban in-person group, $247 in the urban online group and $200 in the regional group.
DISCUSSION


LSVT LOUD® may be delivered via telerehabilitation at a slightly higher cost than in-person delivery from a health-system perspective, but it is cost saving from a patient perspective. Telerehabilitation is an economically beneficial alternative for the delivery of the LSVT LOUD® programme in PD patients with speech disorders.",2020,Telerehabilitation is an economically beneficial alternative for the delivery of the LSVT LOUD® programme in PD patients with speech disorders.,"[""people with Parkinson's disease"", ""people with Parkinson's disease (PD"", 'PD patients with speech disorders', 'patients with dysarthria associated with PD']","['LSVT LOUD® programme', 'speech treatment via in-person consultation versus telerehabilitation', 'urban in-person group ( N \u2009=\u200916) or the urban online group ( N \u2009=\u200915), supplemented with a non-randomised group (regional online;  N \u2009=\u200921', 'Lee Silverman Voice Treatment (LSVT LOUD®']",['mean treatment cost'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0013362', 'cui_str': 'Dysarthria'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",,0.100805,Telerehabilitation is an economically beneficial alternative for the delivery of the LSVT LOUD® programme in PD patients with speech disorders.,"[{'ForeName': 'Masnoon', 'Initials': 'M', 'LastName': 'Saiyed', 'Affiliation': 'Centre for Applied Health Economics, School of Medicine, Menzies Health Institute Queensland, Griffith University, Australia.'}, {'ForeName': 'Anne J', 'Initials': 'AJ', 'LastName': 'Hill', 'Affiliation': 'University of Queensland, School of Health and Rehabilitation Sciences, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Russell', 'Affiliation': 'University of Queensland, School of Health and Rehabilitation Sciences, Australia.'}, {'ForeName': 'Deborah G', 'Initials': 'DG', 'LastName': 'Theodoros', 'Affiliation': 'University of Queensland, School of Health and Rehabilitation Sciences, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scuffham', 'Affiliation': 'Centre for Applied Health Economics, School of Medicine, Menzies Health Institute Queensland, Griffith University, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20948302']
2654,32847494,Effectiveness of an online education intervention on stress and coping of family members after placing a relative with dementia into a residential care facility: protocol of a randomised controlled trial.,"BACKGROUND


After residential care placement, family members may be exposed to stressors like difficulty in role changes, interpersonal conflict with facility staff, and emotional torment. These can threaten family members' own health and well-being and even influence the extent they involve in their relative's care. This study aims to evaluate an online education intervention for Chinese family members whose relatives with dementia have been placed into a residential care facility.
METHODS


This protocol describes a two-arm randomised controlled trial. A total of 150 family members of residents with dementia will be recruited from four to six residential care facilities in Xi'an, Shaanxi, China and randomly allocated to either the intervention or control group. Family members in the intervention group will receive a six-week group-based online education intervention, while those in the control group will receive routine care. Family members' stress, coping, caregiving burden, and family involvement, as well as their relative's behavioural and psychological symptoms of dementia will be assessed at immediately post-intervention and six-week follow-up. Effectiveness of the intervention will be analysed by generalised estimating equation model, based on the intention-to-treat principle. A process evaluation of the intervention will also be undertaken.
DISCUSSION


This study will be of great significance in addressing family members' stressors after institutionalising a relative with dementia and promoting the implementation of family-centred care in practice especially in residential care facilities.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900024582 , Registered 18 July 2019.",2020,"Family members' stress, coping, caregiving burden, and family involvement, as well as their relative's behavioural and psychological symptoms of dementia will be assessed at immediately post-intervention and six-week follow-up.","['family members after placing a relative with dementia into a residential care facility', ""150 family members of residents with dementia will be recruited from four to six residential care facilities in Xi'an, Shaanxi, China and randomly allocated to either the intervention or control group"", 'Chinese family members whose relatives with dementia have been placed into a residential care facility']","['six-week group-based online education intervention, while those in the control group will receive routine care', 'online\xa0education intervention', 'online education intervention']",[],"[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]",[],,0.117294,"Family members' stress, coping, caregiving burden, and family involvement, as well as their relative's behavioural and psychological symptoms of dementia will be assessed at immediately post-intervention and six-week follow-up.","[{'ForeName': 'Zhaozhao', 'Initials': 'Z', 'LastName': 'Hui', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Room 601, 6/F, Esther Lee Building, Hong Kong, SAR, China. huizhaozhao93@link.cuhk.edu.hk.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Room 601, 6/F, Esther Lee Building, Hong Kong, SAR, China.'}, {'ForeName': 'Jieqiong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Nursing, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Diana Tze Fan', 'Initials': 'DTF', 'LastName': 'Lee', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Room 601, 6/F, Esther Lee Building, Hong Kong, SAR, China.'}]",BMC geriatrics,['10.1186/s12877-020-01711-8']
2655,32847705,The effect of motivational interviewing on the change of breast cancer screening behaviors among rural Iranian women.,"OBJECTIVE


The study aimed to determine the effect of motivational interviewing on the change of breast cancer screening behaviors among rural Iranian women.
METHODS


This Randomized controlled trial (RCT) was performed on 120 Iranian rural women selected through cluster random sampling method. Out of all 20 rural health centers of Abish Ahmad District, in the northwest of Iran, about one third (six clusters) were randomly selected; out of which three were randomly assigned to the control group and three to the intervention group. A list of women aged 40-69 years in the selective health centers was prepared and 60 participants were selected for each group through the convenience sampling method based on the inclusion and exclusion criteria. Then, six group sessions (two educational and four motivational interviewing sessions) were held for the intervention group. The data were collected using demographic and obstetric questionnaire, paper-based health records, and the stages of change checklist and analyzed in SPSS 24. The groups were compared through the chi square test, homogeneity test, and the sequential logistic regression with generalized estimating equations.
RESULTS


Two months after the intervention, a significant difference was found between the two groups in terms of the stages of change for clinical breast examination and mammography by taking into account the pre-intervention stages (p = 0.001).
CONCLUSION


MI-based counseling increased the Iranian rural women's motivation for displaying breast cancer screening behaviors.
PRACTICE IMPLICATIONS


The application of MI for enhancing cancer screening programs among Iranian women is suggested.",2020,", a significant difference was found between the two groups in terms of the stages of change for clinical breast examination and mammography by taking into account the pre-intervention stages (p = 0.001).
","['rural Iranian women', '120 Iranian rural women selected through cluster random sampling method', 'women aged 40-69 years in the selective health centers was prepared and 60 participants were selected for each group through the convenience sampling method based on the inclusion and exclusion criteria', '20 rural health centers of Abish Ahmad District, in the northwest of Iran, about one third (six clusters) were randomly selected; out of which three', 'Iranian women']","['MI-based counseling', 'motivational interviewing']","['clinical breast examination and mammography', 'breast cancer screening behaviors']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035960', 'cui_str': 'Rural health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",120.0,0.0319238,", a significant difference was found between the two groups in terms of the stages of change for clinical breast examination and mammography by taking into account the pre-intervention stages (p = 0.001).
","[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Alizadeh-Sabeg', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Mehrabi', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Nourizadeh', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: nourizadehr@tbzmed.ac.ir.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Hakimi', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.011']
2656,32847731,Probiotic supplementation elicits favourable changes in muscle soreness and sleep quality in rugby players.,"Probiotic supplementation may offer team sport athletes a range of benefits beyond the immune and gastrointestinal systems.
OBJECTIVES


To examine the effects of a probiotic formulation on perceptual markers of sleep quality and quantity, and muscle soreness, leg heaviness and motivation in elite rugby union athletes.
METHODS


A double-blind randomised controlled trial involving 19 elite male rugby athletes was conducted over 17 weeks encompassing both domestic and international competition. Psychometric variables and salivary biomarkers were assessed twice a week. Athletes were assigned either a daily probiotic (Ultrabiotic 60™) and Saccharomyces boulardii (during international competition) or a placebo. Associations between psychometric scores for perceptual and salivary biomarkers of sleep (melatonin) and inflammation C-reactive protein (CRP) were investigated.
RESULTS


Muscle soreness was ∼0.5 units lower (F(1, 343)=42.646, p<0.0001) and leg heaviness scores ∼0.7 units lower (F(1, 334)=28.990, p<0.0001) in the probiotic group compared to the placebo group. Across both groups, as self-reported muscle soreness scores and salivary CRP concentrations increased, sleep quantity, quality and motivation scores decreased. Conversely as muscle soreness scores and CRP decreased, sleep quantity and quality, and motivation scores improved.
CONCLUSIONS


A long-term programme of probiotic supplementation in international-level rugby union players may yield favourable effects on self-reported muscle soreness and sleep quality associated with muscle soreness during training and competitions.",2020,"RESULTS


Muscle soreness was ∼0.5 units lower (F(1, 343)=42.646, p<0.0001) and leg heaviness scores ∼0.7 units lower (F(1, 334)=28.990, p<0.0001) in the probiotic group compared to the placebo group.","['rugby players', 'elite rugby union athletes', '19 elite male rugby athletes was conducted over 17 weeks encompassing both domestic and international competition', 'international-level rugby union players']","['probiotic formulation', 'probiotic supplementation', 'daily probiotic (Ultrabiotic 60™) and Saccharomyces boulardii', 'Probiotic supplementation', 'placebo']","['Muscle soreness', 'muscle soreness scores and salivary CRP concentrations increased, sleep quantity, quality and motivation scores', 'muscle soreness scores and CRP decreased, sleep quantity and quality, and motivation scores improved', 'muscle soreness and sleep quality', 'perceptual markers of sleep quality and quantity, and muscle soreness, leg heaviness and motivation', 'leg heaviness scores ∼0.7 units lower', 'psychometric scores for perceptual and salivary biomarkers of sleep (melatonin) and inflammation C-reactive protein (CRP', 'Psychometric variables and salivary biomarkers']","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0877451', 'cui_str': 'C-reactive protein decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",19.0,0.295725,"RESULTS


Muscle soreness was ∼0.5 units lower (F(1, 343)=42.646, p<0.0001) and leg heaviness scores ∼0.7 units lower (F(1, 334)=28.990, p<0.0001) in the probiotic group compared to the placebo group.","[{'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Harnett', 'Affiliation': 'The University of Sydney School of Pharmacy, Faculty of Medicine and Health, Australia.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Pyne', 'Affiliation': 'UC Research Institute for Sport and Exercise, University of Canberra, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McKune', 'Affiliation': 'UC Research Institute for Sport and Exercise, University of Canberra, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Penm', 'Affiliation': 'The University of Sydney School of Pharmacy, Faculty of Medicine and Health, Australia.'}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Pumpa', 'Affiliation': 'UC Research Institute for Sport and Exercise, University of Canberra, Australia; Rugby Australia, Australia. Electronic address: Kate.Pumpa@canberra.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.08.005']
2657,32847754,Remote ischemic preconditioning in a setting of electrical cardioversion of early onset persistent atrial fibrillation (RIP CAF trial): Rationale and study design.,"BACKGROUND


The beneficial effect of remote ischemic preconditioning (RIP) on electrophysiological parameters resulting in lower inducibility and sustainability of atrial fibrillation (AF) in patients with paroxysmal AF has been recently demonstrated in a randomized trial. However, the potential clinical impact of RIP on persistent AF (CAF) has not been investigated. Therefore, we designed a randomized trial set in a setting of electrical cardioversion (CV) of early onset CAF.
AIM


The aim of the study is to answer the following questions: I) Does RIP have impact on rate of spontaneous conversion into sinus rhythm (SR) within 24 h after first RIP intervention? II) Does RIP have the potential to improve the acute outcome of CV following a standardized protocol?
METHODS


The presented study is a two-armed randomized, placebo-controlled, double-blinded, multi-center trial in a cohort of 588 patients with early onset CAF referred for electrical CV. The patients will undergo 3 sessions (immediately after randomization, the following morning, and directly before scheduled CV 24 h after randomization) of either RIP intervention or a sham procedure. The primary outcome of the study, i.e. documentation of SR 24 h after randomization as well secondary outcome i.e. stable SR first CV without usage of anti-arrhythmic drugs will be documented by 12-lead surface electrocardiography.
CONCLUSION


Previously observed positive effect of RIP on atrial electrophysiology might be also implemented in a clinical setting of CV and therefore simplified and improve patient treatment.",2020,"BACKGROUND


The beneficial effect of remote ischemic preconditioning (RIP) on electrophysiological parameters resulting in lower inducibility and sustainability of atrial fibrillation (AF) in patients with paroxysmal AF has been recently demonstrated in a randomized trial.","['patients with paroxysmal AF', 'early onset persistent atrial fibrillation (RIP CAF trial', '588 patients with early onset CAF referred for electrical CV']","['electrical cardioversion (CV', 'placebo', 'remote ischemic preconditioning (RIP', 'Remote ischemic preconditioning', 'RIP intervention']","['rate of spontaneous conversion into sinus rhythm (SR', 'documentation of SR 24\u2009h after randomization as well secondary outcome i.e. stable SR first CV without usage of anti-arrhythmic drugs will be documented by 12-lead surface electrocardiography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",588.0,0.312458,"BACKGROUND


The beneficial effect of remote ischemic preconditioning (RIP) on electrophysiological parameters resulting in lower inducibility and sustainability of atrial fibrillation (AF) in patients with paroxysmal AF has been recently demonstrated in a randomized trial.","[{'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Kosiuk', 'Affiliation': 'Department of Rhythmology, Helios Clinic Kothen, Kothen, Germany. Electronic address: jedrzej.kosiuk@helios-gesundheit.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Langenhan', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bollmann', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Dagres', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, Leipzig, Germany.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.07.024']
2658,32847776,Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial.,"OBJECTIVE


Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined.
DESIGN


A parallel, randomized, placebo-controlled trial.
SETTING


Tertiary level oncology center.
PATIENTS


88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited.
INTERVENTION


Participants were randomly allocated into 4 equal groups received 2 h preoperatively, placebo (D0, N = 22), Duloxetine 30 mg (D30, N = 22), Duloxetine 60 mg (D60, N = 22) and Duloxetine 90 mg (D90, N = 22) tablet.
MEASUREMENTS


The primary outcome; 24 h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting) were measured.
RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
CONCLUSION


Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects.
TRIAL REGISTRATION


The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348.",2020,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","['88 female patients with breast cancer', 'patients undergoing modified radical mastectomy', 'Tertiary level oncology center']","['Duloxetine', 'modified radical mastectomy (MRM) with ASA class', '2\xa0h preoperatively, placebo', 'Duloxetine 30\xa0mg (D30, N\xa0=\xa022), Duloxetine 60\xa0mg (D60, N\xa0=\xa022) and Duloxetine 90\xa0mg (D90, N\xa0=\xa022) tablet', 'placebo', 'morphine', 'Preoperative Duloxetine']","['level of sedation', 'analgesic efficacy and side effects', '24\xa0h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting', 'vomiting', 'median (IQR) consumption', 'acute pain and quality of recovery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1616501', 'cui_str': 'duloxetine 30 MG [Cymbalta]'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",88.0,0.273346,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Nourhan Alaa', 'Initials': 'NA', 'LastName': 'Elgalaly', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Helal F', 'Initials': 'HF', 'LastName': 'Hetta', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Department of Medical Microbiology and Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: Helal.hetta@uc.edu.'}, {'ForeName': 'Montaser A', 'Initials': 'MA', 'LastName': 'Fattah Mohammad', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110007']
2659,32847570,Does moxonidine reduce Achilles tendon or musculoskeletal pain in women with polycystic ovarian syndrome? A secondary analysis of a randomised controlled trial.,"BACKGROUND


Sympathetic activity and insulin resistance have recently been linked with chronic tendon and musculoskeletal pain. Polycystic ovarian syndrome is linked with insulin resistance and increased sympathetic drive and was therefore an appropriate condition to study the effects of modulating sympathetic activity on Achilles tendon and musculoskeletal symptoms.
METHODS


A secondary analysis of a double-blinded, randomised controlled trial on women with polycystic ovarian syndrome was conducted. Participants received 12 weeks of moxonidine (n = 14) or placebo (n = 18). Musculoskeletal symptom and Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaires were distributed, and ultrasound tissue characterisation quantified tendon structure at 0 and 12 weeks. 2-way ANOVA was used for multiple comparisons.
RESULTS


There was no difference in mean change in musculoskeletal symptoms (- 0.6 ± 1.7 vs - 0.4 ± 1.8, p = 0.69) or VISA-A (moxonidine - 0.2 ± 8.8 vs placebo + 4.2 ± 14.6, p = 0.24) attributable to the intervention. There was no difference in any measures of Achilles structure. Moxonidine did not reduce sympathetic drive when compared to placebo.
CONCLUSIONS


This was the first study to investigate the effects of blocking sympathetic drive on musculoskeletal and Achilles tendon symptoms in a metabolically diverse population. While the study was limited by small sample size and lack of sympathetic modulation, moxonidine did not change tendon pain/structure or musculoskeletal symptoms.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01504321 . Registered 5 January 2012.",2020,"Moxonidine did not reduce sympathetic drive when compared to placebo.
","['Polycystic ovarian syndrome', 'musculoskeletal and Achilles tendon symptoms in a metabolically diverse population', 'women with polycystic ovarian syndrome']","['Moxonidine', 'blocking sympathetic drive', 'placebo', 'moxonidine']","['Achilles structure', 'musculoskeletal pain', 'Musculoskeletal symptom and Victorian Institute of Sport Assessment - Achilles', 'sympathetic drive', 'mean change in musculoskeletal symptoms']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0066837', 'cui_str': 'moxonidine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0231443', 'cui_str': 'Musculoskeletal symptom'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.665627,"Moxonidine did not reduce sympathetic drive when compared to placebo.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Jewson', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia. jacobjewson@gmail.com.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lambert', 'Affiliation': 'Iverson Health Innovation Research Institute and School of Health Sciences, Swinburne University of Technology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sari', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Jona', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Soulmaz', 'Initials': 'S', 'LastName': 'Shorakae', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Lambert', 'Affiliation': 'Iverson Health Innovation Research Institute and School of Health Sciences, Swinburne University of Technology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gaida', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise (UCRISE), Canberra, ACT, Australia.'}]",BMC endocrine disorders,['10.1186/s12902-020-00610-8']
2660,32847593,Comparison of targeted percutaneous vertebroplasty and traditional percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression fractures in the elderly.,"OBJECTIVE


To investigate the clinical effect of precise puncture and low-dose bone cement in percutaneous vertebroplasty (PVP).
METHODS


Sixty patients with osteoporotic vertebral compression fracture (OVCFs) who were treated with PVP in our hospital from July 2018 to June 2019. These included patients were divided into group A (N = 30) and group B (N = 30). Group A has punctured to the fracture area accurately and injected with a small dose of bone cement, the group B was injected with a conventional dose of bone cement. The operation time, the amount of bone cement injection, the number of X-rays, the VAS scores, the leakage rate of bone cement, and the incidence of adjacent vertebral fractures were compared between the two groups.
RESULT


The operation time, fluoroscopic times, and bone cement volume in group A are less than that in group B (P < 0.05). Patients in group A had a lower incidence of cement leakage and adjacent vertebral fracture than that in patients in group B. There was no significant difference in postoperative pain relief between the two groups.
CONCLUSIONS


Precise puncture and injection of small doses of bone cement can reduce the number of X-ray fluoroscopy, operation time, amount of bone cement injection, reduce the rate of bone cement leakage and the incidence of adjacent vertebral fractures, which is a safe and effective surgical approach for the treatment for the aged with OVCFs.",2020,Patients in group A had a lower incidence of cement leakage and adjacent vertebral fracture than that in patients in group,"['osteoporotic vertebral compression fractures in the elderly', 'Sixty patients with osteoporotic vertebral compression fracture (OVCFs) who were treated with PVP in our hospital from July 2018 to June 2019']","['precise puncture and low-dose bone cement', 'percutaneous vertebroplasty and traditional percutaneous vertebroplasty']","['operation time, fluoroscopic times, and bone cement volume', 'postoperative pain relief', 'cement leakage and adjacent vertebral fracture', 'operation time, the amount of bone cement injection, the number of X-rays, the VAS scores, the leakage rate of bone cement, and the incidence of adjacent vertebral fractures', 'rate of bone cement leakage']","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",60.0,0.0158367,Patients in group A had a lower incidence of cement leakage and adjacent vertebral fracture than that in patients in group,"[{'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China.'}, {'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Geng', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China.'}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China.'}, {'ForeName': 'Zhongchuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China.'}, {'ForeName': 'Xunbing', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Bengbu Medical College, Bengbu, 233000, China. zhuxunbingzxb@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01875-4']
2661,32847622,Delivery of a Mental Health First Aid training package and staff peer support service in secondary schools: a process evaluation of uptake and fidelity of the WISE intervention.,"BACKGROUND


Improving children and young people's provision for mental health is a current health priority in England. Secondary school teachers have worse mental health outcomes than the general working population, which the Wellbeing in Secondary Education (WISE) cluster randomised controlled trial aimed to improve. The WISE intervention comprised a Mental Health First Aid (MHFA) training package delivered to at least 16% of staff, a short mental health awareness session to all teachers and development of a staff peer support service. Twenty-five schools were randomised to intervention or control arms. This paper reports findings regarding the extent of uptake and fidelity of the intervention.
METHODS


Mixed methods data collection comprised researcher observations of training delivery, training participant evaluation forms, trainer and peer supporter interviews, peer supporter feedback meetings, logs of support provided, and teacher questionnaires. Quantitative data were summarised descriptively, while thematic analysis was applied to the qualitative data.
RESULTS


In the 12 schools assigned to the intervention arm, 113 (8.6%) staff completed the 2-day standard MHFA training course, and a further 146 (11.1%) staff completed the 1-day MHFA for schools and colleges training. In seven (58.3%) schools, the required 8% of staff completed the MHFA training packages. A 1-h mental health awareness-raising session was attended by 666 (54.5%) staff. Delivery of the MHFA training package was achieved with high levels of fidelity and quality across schools. All schools set up the peer support service following training, with a majority adhering to most of the operational guidelines developed from the pilot study at the outset. Teachers reported limited use of the peer support service during follow-up. At the 1-year follow-up, only three (25.0%) schools indicated they had re-advertised the service and there was evidence of a reduction in support from senior leadership.
CONCLUSION


The MHFA training package was delivered with reasonably high fidelity, and a staff peer support service was established with general, but not complete, adherence to guidelines. In some schools, insufficient staff received MHFA training and levels of delivery of the peer support service compromised intervention dose and reach.
TRIAL REGISTRATION


ISRCTN 95909211 . Registered on 15 January 2016.",2020,"In the 12 schools assigned to the intervention arm, 113 (8.6%) staff completed the 2-day standard MHFA training course, and a further 146 (11.1%) staff completed the 1-day MHFA for schools and colleges training.","['Twenty-five schools', 'secondary schools']","['MHFA training package', 'Mental Health First Aid training package and staff peer support service', 'Mental Health First Aid (MHFA) training package delivered\xa0to at least 16% of staff, a short mental health awareness session to all teachers and development of a staff peer support service']",['mental health outcomes'],"[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",25.0,0.0522352,"In the 12 schools assigned to the intervention arm, 113 (8.6%) staff completed the 2-day standard MHFA training course, and a further 146 (11.1%) staff completed the 1-day MHFA for schools and colleges training.","[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harding', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Copeland', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': 'Health Service and Population Research Department, Kings College London, London, UK.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gunnell', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Kidger', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Judi.Kidger@bristol.ac.uk.'}]",Trials,['10.1186/s13063-020-04682-8']
2662,32847626,The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


To investigate the effect of continuous infusion of the potential endothelial cytoprotective agent prostacyclin (Iloprost) 1 ng/kg/min vs. placebo for 72 hours on pulmonary endotheliopathy in mechanically ventilated COVID-19 patients.
TRIAL DESIGN


A multicenter, randomized (1:1, active: placebo), blinded, parallel group exploratory trial PARTICIPANTS: Inclusion criteria are: Adult patients (>18 years); Confirmed COVID-19 infection; Need for mechanical interventions; Endothelial biomarker soluble thrombomodulin >4ng/ml.
EXCLUSION CRITERIA


Withdrawal from active therapy; Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG); Known hypersensitivity to iloprost or to any of the other ingredients; Previously included in this trial or a prostacyclin trial within 30 days; Consent cannot be obtained; Life-threatening bleeding defined by the treating physician; Known severe heart failure (NYHA class IV); Suspected acute coronary syndrome The study is conducted at five intensive care units in the Capital Region of Denmark at Rigshospitalet, Herlev Hospital, Hvidovre Hospital, Bispebjerg Hospital, Nordsjællands Hospital.
INTERVENTION AND COMPARATOR


The patients are randomized to 72-hours continuous infusion of either prostacyclin (Iloprost/Ilomedin) at a dose of 1 ng/kg/min or Placebo (normal saline).
MAIN OUTCOMES


Primary endpoint: Days alive without mechanical ventilation in the intensive care units within 28 days RANDOMISATION: The randomisation sequence is performed in permuted blocks of variable sizes stratified for trial site using centralised, concealed allocation. The randomisation sequence is generated 1:1 (active/placebo) using the online randomisation software 'Sealed Envelope' ( https://www.sealedenvelope.com/ ). Once generated the randomisation sequence is formatted and uploaded into Research Electronic Data Capture system (REDCap) to facilitate centralised, web-based allocation according to local written instruction.
BLINDING (MASKING)


The following are blinded: all clinicians, patients, investigators, and those assessing the outcomes including the statisticians.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Forty patients are planned to be randomized to each group, with a total sample size of 80 patients.
TRIAL STATUS


Protocol version 1.4 dated May 25, 2020. Recruitment is ongoing. The recruitment was started June 15, 2020 and the anticipated finish of recruitment is February 28, 2021 with 90 days follow up hereafter.
TRIAL REGISTRATION


Trial registration at clinicaltrialregisters.eu; EudraCT no. 2020-001296-33 on 3 April 2020 and at ClinicalTrials.gov Identifier: NCT04420741 on 9 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The randomisation sequence is generated 1:1 (active/placebo) using the online randomisation software 'Sealed Envelope' ( https://www.sealedenvelope.com/ ).,"['Forty patients are planned to be randomized to each group, with a total sample size of 80 patients', 'mechanically ventilated patients with COVID-19', 'Protocol version 1.4 dated May 25, 2020', 'five intensive care units in the Capital Region of Denmark at Rigshospitalet, Herlev Hospital, Hvidovre Hospital, Bispebjerg Hospital, Nordsjællands Hospital', 'mechanically ventilated COVID-19 patients', 'patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG']","['mechanical interventions; Endothelial biomarker soluble thrombomodulin ', 'prostacyclin (Iloprost/Ilomedin', 'endothelial cytoprotective agent prostacyclin (Iloprost) 1 ng/kg/min vs. placebo', 'prostacyclin (Iloprost', 'placebo', 'Placebo (normal saline']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1268903', 'cui_str': 'Cytoprotective agent'}, {'cui': 'C1320753', 'cui_str': 'ng/kg/min'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]",[],,0.675547,The randomisation sequence is generated 1:1 (active/placebo) using the online randomisation software 'Sealed Envelope' ( https://www.sealedenvelope.com/ ).,"[{'ForeName': 'Pär Ingemar', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, Copenhagen, Denmark. per.johansson@regionh.dk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bestle', 'Affiliation': 'Department of Intensive Care, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Søe-Jensen', 'Affiliation': 'Department of Intensive Care, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Klaus Tjelle', 'Initials': 'KT', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Intensive Care, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stensballe', 'Affiliation': 'Department of Anaesthesiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niels Erikstrup', 'Initials': 'NE', 'LastName': 'Clausen', 'Affiliation': 'Department of Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care 4131, Rigshospitalet, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04696-2']
2663,32847638,Ultra-processed foods and early childhood caries in 0-3-year-olds enrolled at Primary Healthcare Centers in Southern Brazil.,"OBJECTIVE


To investigate the relationship between ultra-processed food consumption and early childhood caries.
DESIGN


Cross-sectional analysis of baseline data from a cluster randomised controlled study. Outcomes included the prevalence of children with non-cavitated and cavitated caries. The main exposure was the total daily consumption of ultra-processed foods (up to three times and four times or more), assessed through a FFQ. Potential confounders were socio-demographic characteristics of the child and caregiver/family, child breast-feeding, oral hygiene and use of dental services. Poisson regression using robust variance adjustment was used to estimate prevalence ratios (PR) and their respective 95 % CI.
SETTING


Primary Healthcare Centers in an urban area of Pelotas, Southern Brazil.
PARTICIPANTS


Children aged 0-3 years (n 309).
RESULTS


Consumption of ultra-processed foods four times or more a day was found in 67·6 % of children; 24·4 and 12·0 % presented non-cavitated and cavitated caries, respectively. After adjustment, children who consumed ultra-processed foods four times or more a day were more likely to present both non-cavitated caries (PR 2·25, 95 % CI 1·19, 4·27, P = 0·013) and cavitated caries (PR 3·48, 95 % CI 1·18, 10·30, P = 0·024) compared with those who have consumed them up to three times a day.
CONCLUSIONS


Consumption of ultra-processed foods is associated with early childhood caries. Interventions aiming at reducing ultra-processed food consumption should be implemented to improve children's oral health.",2020,"After adjustment, children who consumed ultra-processed foods four times or more a day were more likely to present both non-cavitated caries (PR 2·25, 95 % CI 1·19, 4·27, P = 0·013) and cavitated caries (PR 3·48, 95 % CI 1·18, 10·30, P = 0·024) compared with those who have consumed them up to three times a day.
","['Primary Healthcare Centers in an urban area of Pelotas, Southern Brazil', 'and early childhood caries in 0-3-year-olds enrolled at Primary Healthcare Centers in Southern Brazil', 'Children aged 0-3 years (n 309']",['Ultra-processed foods'],"['prevalence ratios (PR', 'prevalence of children with non-cavitated and cavitated caries', 'cavitated caries', 'total daily consumption of ultra-processed foods']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience food'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C4038980', 'cui_str': 'Cavitated caries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}]",,0.148675,"After adjustment, children who consumed ultra-processed foods four times or more a day were more likely to present both non-cavitated caries (PR 2·25, 95 % CI 1·19, 4·27, P = 0·013) and cavitated caries (PR 3·48, 95 % CI 1·18, 10·30, P = 0·024) compared with those who have consumed them up to three times a day.
","[{'ForeName': 'Maurício Santos', 'Initials': 'MS', 'LastName': 'de Souza', 'Affiliation': 'School of Dentistry, Department of Social and Preventive Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Juliana Dos Santos', 'Initials': 'JDS', 'LastName': 'Vaz', 'Affiliation': 'School of Nutrition, Department of Nutrition, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Martins-Silva', 'Affiliation': 'School of Medicine, Department of Social Medicine, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Rafael Aiello', 'Initials': 'RA', 'LastName': 'Bomfim', 'Affiliation': 'School of Dentistry, Department of Dentistry and Community Health, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Morales Cascaes', 'Affiliation': 'Department of Public Health, Federal University of Santa Catarina, Florianópolis, SC, Brazil.'}]",Public health nutrition,['10.1017/S1368980020002839']
2664,32847643,Feasibility and acceptability evaluation of the Promoting Independence in Dementia (PRIDE) intervention for living well with dementia.,"OBJECTIVES


Post-diagnostic psychosocial interventions could play an important role in supporting people with mild dementia remain independent. The Promoting Independence in Dementia (PRIDE) intervention was developed to address this.
METHOD


The mixed methods non-randomized, pre-post feasibility study occurred across England. Facilitators were recruited from the voluntary sector and memory services. Participants and their supporters took part in the three-session intervention. Outcome measures were collected at baseline and follow-up. To evaluate acceptability, focus groups and interviews were conducted with a subsample of participants and facilitators.
RESULTS


Contextual challenges to delivery including national research governance changes, affected recruitment of study sites. Thirty-four dyads consented, with 14 facilitators providing the intervention. Dyads took part in at least two sessions (79%), and 73% in all three. Outcome measures were completed by 79% without difficulty, with minimal missing data. No significant changes were found on pre and post assessments. Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40). Qualitative data indicated that dyads found PRIDE acceptable, as did intervention facilitators.
CONCLUSIONS


The three-session intervention was well accepted by participant-dyads and intervention facilitators. A randomized controlled trial of PRIDE would need to carefully consider recruitment potential across geographically varied settings and site stratification according to knowledge of contextual factors, such as the diversity of post-diagnostic services across the country. Letting sites themselves be responsible for identifying suitable intervention facilitators was successful. The self-report measures showed potential to be included in the main trial.",2020,Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40).,"['Dementia (PRIDE) intervention for living well with dementia', 'Thirty-four dyads consented, with 14 facilitators providing the intervention']",[],['quality of life (EQ5D measure'],"[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",34.0,0.067419,Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40).,"[{'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Csipke', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Esme', 'Initials': 'E', 'LastName': 'Moniz-Cook', 'Affiliation': 'Faculty of Health Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Phuong', 'Initials': 'P', 'LastName': 'Leung', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Yates', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Birt', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Walton', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Eef', 'Initials': 'E', 'LastName': 'Hogervorst', 'Affiliation': 'National Centre for Sports and Exercise Medicine, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mountain', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Charlesworth', 'Affiliation': 'Clinical Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}]",International psychogeriatrics,['10.1017/S1041610220001386']
2665,32847664,Child Life Interventions for Pediatric Dental Patients: A Pilot Study.,"Purpose:  The purpose of this pilot study was to assess whether child life intervention can be an effective alternative to pharmacologic behavior management in uncooperative pediatric dental patients.  Methods:  Thirty uncooperative four- to eight-year-old patients with no history of a negative invasive dental experience were randomly assigned into two groups: experimental (E) and control (C). Group E was given two 30- minute child life interventions (CLIs) by a certified child life specialist. Group C did not receive CLIs. Both groups then had an invasive restorative dental appointment, which was video recorded, edited, and viewed to assess behavior via the Houpt scale.  Results:  Group E demonstrated overall better cooperation for the appointment (Group C equals 3.63, and group E equals 4.07.)  Conclusions:  Child life interventions may be considered an adjunct to other behavior guidance techniques, but further investigations should be conducted to evaluate the effectiveness of CLIs on behavior in the dental setting.",2020,"Group E demonstrated overall better cooperation for the appointment (Group C equals 3.63, and group E equals 4.07.)  ","['Thirty uncooperative four- to eight-year-old patients with no history of a negative invasive dental experience', 'Pediatric Dental Patients', 'uncooperative pediatric dental patients']","['CLIs', 'child life intervention']",['overall better cooperation'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0424350', 'cui_str': 'Uncooperative behavior'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.0255168,"Group E demonstrated overall better cooperation for the appointment (Group C equals 3.63, and group E equals 4.07.)  ","[{'ForeName': 'Ty', 'Initials': 'T', 'LastName': 'Hinze', 'Affiliation': 'Dr. Hinze is a dentist in private practice, Frisco, Texas, USA.'}, {'ForeName': 'Cinda', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'Ms. McDonald is a child life specialist, and director, Palliative Care Child Life Services, Baylor University Medical Center, Texas, USA.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Kerins', 'Affiliation': 'Dr. Kerins is associate professor and graduate program director, Texas, USA;, Email: ckerins@tamu.edu.'}, {'ForeName': 'Alton G', 'Initials': 'AG', 'LastName': 'McWhorter', 'Affiliation': 'Dr. McWhorter is chairman, Department of Pediatric Dentistry, College of Dentistry, Texas A&M, Dallas, Texas, USA.'}]",Pediatric dentistry,[]
2666,32847700,"Re: The Effect of Antioxidants on Male Factor Infertility: The Males, Antioxidants, and Infertility (MOXI) Randomized Clinical Trial.",,2020,,['Male Factor Infertility'],['Antioxidants'],"['Males, Antioxidants, and Infertility (MOXI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]",,0.275223,,"[{'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Kuchakulla', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ranjith', 'Initials': 'R', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: ramasamy@miami.edu.'}]",European urology,['10.1016/j.eururo.2020.08.008']
2667,32847916,Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial.,"INTRODUCTION


Falls risk poststroke is highest soon after discharge from rehabilitation. Reactive balance training (RBT) aims to improve control of reactions to prevent falling after a loss of balance. In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life. While increasing the dose of RBT does not appear to lead to additional benefit for healthy older adults, stroke survivors, who have more severely impaired balance control, may benefit from a higher RBT dose. Our long-term goal is to determine the optimal dose of RBT in people with subacute stroke. This assessor-blinded pilot randomised controlled trial aims to inform the design of a larger trial to address this long-term goal.
METHODS AND ANALYSIS


Participants (n=36) will be attending out-patient stroke rehabilitation, and will be randomly allocated to one of three groups: one, three or six RBT sessions. RBT will replace a portion of participants' regular physiotherapy so that the total physical rehabilitation time will be the same for the three groups. Balance and balance confidence will be assessed at: (1) study enrolment; (2) out-patient rehabilitation discharge; and (3) 6 months postdischarge. Participants will report falls and physical activity for 6 months postdischarge. Pilot data will be used to plan the larger trial (ie, sample size estimate using fall rates, and which groups should be included based on between-group trends in pre-to-post training effect sizes for reactive balance control measures). Pilot data will also be used to assess the feasibility of the larger trial (ie, based on the accrual rate, outcome completion rate and feasibility of prescribing specific training doses).
ETHICS AND DISSEMINATION


Institutional research ethics approval has been received. Study participants will receive a lay summary of results. We will also publish our findings in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT04219696; Pre results.",2020,"In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life.","['people with subacute stroke', 'healthy older adults, stroke survivors', 'Participants (n=36) will be attending out-patient stroke rehabilitation', 'healthy older adults']","['reactive balance training', 'Reactive balance training (RBT', 'RBT session', 'RBT']",['Balance and balance confidence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",36.0,0.211706,"In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life.","[{'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Mansfield', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada avril.mansfield@uhn.ca.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Inness', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Danells', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jagroop', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Bhatt', 'Affiliation': 'Department of Physical Therapy, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Huntley', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2020-038073']
2668,32847917,"Efficacy and safety of high-dose Xueshuantong injection (lyophilised) in reducing the incidence of major adverse cardiovascular events in patients with unstable angina: a protocol of a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial based on dual antiplatelet therapy.","INTRODUCTION


Unstable angina (UA), referred to as acute coronary syndrome (ACS), causes unexpected chest pain. Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS. However, no clinical trial has been performed in this field. This clinical trial aims to examine the efficacy and safety of XST.
METHODS AND ANALYSIS


This is a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial. A total of 1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group. The efficacy assessment and major adverse cardiovascular events will be observed, and the frequency of angina attack, angina pectoris will be examined at the start and end of the run-in period. All adverse events will be recorded, regardless of the severity, to assess the safety of XST. The baseline characteristics of patients will be summarised and compared using the  t  test or non-parametric statistical test. Qualitative data will be analysed using the χ 2  or Fisher exact tests, Cochran-Mantel-Hasenszel test and Wilcoxon test.
ETHICS AND DISSEMINATION


This trial has been approved by the Research Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2017] 0021). Written informed consent will be obtained from all participants. The results of this trial will be disseminated to the public through academic conferences and peer-reviewed journals.
TRIAL REGISTRATION


This study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the ID ChiCTR1800015911.",2020,Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS.,"['1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group', 'patients with unstable angina']","['high-dose Xueshuantong injection (lyophilised', 'Xueshuantong injection (lyophilised) (XST']","['efficacy assessment and major adverse cardiovascular events', 'Efficacy and safety', 'frequency of angina attack, angina pectoris']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1956628', 'cui_str': 'Panax notoginseng extract'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1956628', 'cui_str': 'Panax notoginseng extract'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}]",1200.0,0.316559,Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS.,"[{'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'National Drug Clinical Trial Agency Office, Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Clinical Research and Data Center, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tianhui', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': 'National Drug Clinical Trial Agency Office, Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Weiji', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shaoxiang', 'Initials': 'S', 'LastName': 'Xian', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhongqi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China yang_zhongqi@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-038074']
2669,32847918,"Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease.","INTRODUCTION


It is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia.
METHODS AND ANALYSIS


The within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO 2 max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020.
ETHICS AND DISSEMINATION


The study protocol has been approved under Australia's National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618001458224).",2020,It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia.,"['people with coronary heart disease (CHD', 'people with coronary heart disease', 'people with CHD']","['Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation', 'SCRAM', 'usual care cardiac rehabilitation (UC) alone']","['incremental cost-effectiveness ratio', 'maximal oxygen uptake (VO 2 max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument', 'Productivity loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.17886,It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia.,"[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Deakin Health Economics, Deakin University, Burwood, Victoria, Australia lan.gao@deakin.edu.au.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rawstorn', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Nossal Institute for Global Health, University of Melbourne School of Population and Global Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Chow', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McNaughton', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lamb', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Amerena', 'Affiliation': 'Cardiac Services, Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Voltaire', 'Initials': 'V', 'LastName': 'Nadurata', 'Affiliation': 'Department of Cardiology, Bendigo Health, Bendigo, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Neil', 'Affiliation': 'Western Clinical School, The University of Melbourne, Saint Albans, Victoria, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Applied Artificial Intelligence Institute, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'School of Health and Social Development, Deakin University, Burwood, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038178']
2670,32847923,"Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA).","INTRODUCTION


Hyperkalaemia is a common electrolyte disorder and can be life-threatening. In the emergency room (ER), interventions aim to protect patients from the immediate dangers of elevated serum potassium by redistributing potassium ions from the bloodstream into the cells via intravenous insulin or nebulised beta2-agonists. However, to date, evidence for acute management of hyperkalaemia is limited. The aim of this randomised controlled trial is therefore to compare three strategies, namely insulin/glucose intravenous infusion, nebulised salbutamol or a combination of nebulised salbutamol and insulin/glucose intravenous infusion to reduce serum potassium concentration at 60 min as a first-line treatment in patients admitted to the ER with serum potassium concentrations superior or equal to 6 mmol/L.
METHODS AND ANALYSIS


INSAKA is a prospective, multicentre, controlled, open-label, parallel-group, randomised in a 1:1:1 ratio clinical trial. Patients will be eligible for randomisation if they have serum potassium concentrations superior or equal to 6 mmol/L measured in the ER. Patients will receive either: (1) 10 mg of nebulised salbutamol, (2) 10 units of short-acting insulin in an intravenous bolus with 500 mL of 10% glucose or (3) 10 units of short-acting insulin in an intravenous bolus with 500 mL of 10% glucose combined with 10 mg of nebulised salbutamol. The primary endpoint will be the mean change in the absolute serum potassium level from baseline to 60 min measured in mmol/L. We plan to include 525 patients.
ETHICS AND DISSEMINATION


The INSAKA trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practices. All trial documents and procedures have been reviewed and approved by the Ethics Committee Sud Méditerranée III (approval ID number: 19.07.16.36428). The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.
TRIAL REGISTRATION


EudraCT number: 2019-002710-39, Clinicaltrials.gov identifier: NCT04012138.",2020,"The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.
","['patients admitted to the ER with serum potassium concentrations superior or equal to 6\u2009mmol/L', 'acute hyperkalaemia in the emergency room']","['nebulised salbutamol and insulin/glucose intravenous infusion', 'nebulised salbutamol, (2) 10 units of short-acting insulin in an intravenous bolus with 500\u2009mL of 10% glucose or (3) 10 units of short-acting insulin in an intravenous bolus with 500\u2009mL of 10% glucose combined with 10\u2009mg of nebulised salbutamol', 'nebulised salbutamol', 'Insulin glucose infusion versus nebulised salbutamol', 'salbutamol and insulin glucose']","['serum potassium concentration', 'mean change in the absolute serum potassium level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0268022', 'cui_str': 'Acute hyperkalemia'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",,0.175484,"The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.
","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Montassier', 'Affiliation': 'Department of Emergency Medicine, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nantes University Hospital, 44000-Nantes, France emmanuel.montassier@chu-nantes.fr.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Lemoine', 'Affiliation': 'Department of Emergency Medicine, Nantes University Hospital, 44000-Nantes, France.'}, {'ForeName': 'Jean Benoit', 'Initials': 'JB', 'LastName': 'Hardouin', 'Affiliation': 'SPHERE U1246, Inserm, Université de Nantes-Université de Tours, 44000-Nantes, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Institut Lorrain Du Coeur Et Des Vaisseaux Louis Mathieu, Université de Lorraine, Inserm, Centre d'Investigations Cliniques- Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Vandoeuvre-les-nancy, France.""}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Legrand', 'Affiliation': 'Department of Anesthesiology & Peri-operative & Critical Care Medicine, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), University of California, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039277']
2671,32847989,Ambulatory blood pressure monitoring among emergency medical services night shift workers.,"OBJECTIVES


Higher 24-hour blood pressure (BP) and blunted BP dipping during sleep and night-time hours are associated with adverse health outcomes. Night shift work may affect 24-hour BP and dipping patterns, but empirical data in emergency medical services (EMS) clinician shift workers are sparse. We implemented ambulatory blood pressure monitoring (ABPM) in EMS workers to characterise BP during night shift work versus a non-workday, and sleep versus wake.
METHODS


Participants worked night shifts. Hourly ABPM and wrist actigraphy (to measure sleep) were collected during two 24-hour periods, one scheduled night shift and one non-workday. Blunted BP dipping was defined as a BP decrease of <10%.
RESULTS


Of 56 participants, 53 (53.6% female, mean age 26.5 (SD 7.5) years) completed the study. During daytime sleep on a workday, 49.1% of participants had blunted systolic BP (SBP) or diastolic BP (DBP) dipping. During night-time sleep on a non-workday, 25% had blunted SBP dipping and 3.9% blunted DBP dipping. Blunted SBP or DBP dipping occurred among all participants who did not nap during the night shift or who napped <60 min. Blunted SBP dipping occurred in only 14.3% of participants who napped 60-120 min.
CONCLUSIONS


During night shift work, the BP dipping of EMS shift workers is blunted; however, most who nap for 60 min or longer experience a healthy dip in BP. The potential health consequences of these observations in EMS clinicians warrant further study.",2020,Blunted SBP or DBP dipping occurred among all participants who did not nap during the night shift or who napped <60 min.,"['emergency medical services night shift workers', 'Of 56 participants, 53 (53.6% female, mean age 26.5 (SD 7.5) years) completed the study', 'Participants worked night shifts']",['ambulatory blood pressure monitoring (ABPM'],"['Blunted SBP dipping', '24-hour blood pressure (BP', 'Blunted SBP or DBP dipping', 'Hourly ABPM and wrist actigraphy (to measure sleep', 'blunted systolic BP (SBP) or diastolic BP (DBP) dipping', 'Ambulatory blood pressure monitoring']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0555008', 'cui_str': 'Night shift worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0337426', 'cui_str': 'Dipping'}, {'cui': 'C1282173', 'cui_str': '24 hour blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0132177,Blunted SBP or DBP dipping occurred among all participants who did not nap during the night shift or who napped <60 min.,"[{'ForeName': 'P Daniel', 'Initials': 'PD', 'LastName': 'Patterson', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA pdp3@pitt.edu.'}, {'ForeName': 'Kristina A', 'Initials': 'KA', 'LastName': 'Mountz', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Agostinelli', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Weaver', 'Affiliation': ""Departments of Medicine and Neurology, Brigham and Women's Hospital Division of Sleep and Circadian Disorders, Boston, Massachusetts, USA.""}, {'ForeName': 'Yi-Chuan', 'Initials': 'YC', 'LastName': 'Yu', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Herbert', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Markosyan', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hopkins', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Alana C', 'Initials': 'AC', 'LastName': 'Alameida', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Maloney Iii', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Martin', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Bridget N', 'Initials': 'BN', 'LastName': 'Brassil', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Martin-Gill', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",Occupational and environmental medicine,['10.1136/oemed-2020-106459']
2672,32847993,Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol.,"INTRODUCTION


In Nepal, approximately 31% of adult industrial employees have diabetes. While the prevention of type 2 diabetes through behavioural intervention has been disseminated, worksite could be an effective platform for the translation of this knowledge into action as employed adults spend most of their workday waking hours at workplaces.
METHODS AND ANALYSIS


We will conduct a randomised controlled trial to assess the effectiveness of a behavioural and a canteen intervention on diabetes risk reduction among those who are prediabetic at two worksites in eastern Nepal. We will recruit 162 adult full-time factory workers with haemoglobin A1c (HbA1c) of 5.7%-6.4% at baseline or fasting blood sugar of 100-125 mg/dL. The 8-14 months' control period will be followed by the behavioural intervention where half of the participants will be randomised to receive the behavioural intervention and half will act as a control and will not receive any intervention. Then, all participants will receive the canteen intervention. The analysis will be intent-to-treat, comparing the difference in the change in HbA1c% between the behavioural intervention group and the control group using a two-sample t-test. The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Institutional Review Board at Yale School of Public Health, New Havens, USA and the Nepal Health Research Council.
TRIAL REGISTRATION NUMBER


NCT04161937.",2020,"The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.
","['162 adult full-time factory workers with haemoglobin A1c (HbA1c) of 5.7%-6.4% at baseline or fasting blood sugar of 100-125\u2009mg/dL. The 8-14 months', 'diabetes in Nepal', 'diabetes risk reduction among those who are prediabetic at two worksites in eastern Nepal']","['control period will be followed by the behavioural intervention', 'behavioural intervention and half will act as a control and will not receive any intervention', 'behavioural and a canteen intervention', 'Worksite intervention']",[],"[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0403175', 'cui_str': 'Factory worker'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]",[],162.0,0.120864,"The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.
","[{'ForeName': 'Prajjwal', 'Initials': 'P', 'LastName': 'Pyakurel', 'Affiliation': 'B.P. Koirala Institute of Health Sciences, Dharan, Nepal prazzwal@gmail.com.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Kathmandu University School of Medical Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Biraj M', 'Initials': 'BM', 'LastName': 'Karmacharya', 'Affiliation': 'Kathmandu University School of Medical Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Shyam S', 'Initials': 'SS', 'LastName': 'Budhathoki', 'Affiliation': 'Golden Community Hospital, Lalitpur, Nepal.'}, {'ForeName': 'Rajendra Kumar', 'Initials': 'RK', 'LastName': 'Chaudhari', 'Affiliation': 'B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Tamrakar', 'Affiliation': 'Kathmandu University School of Medical Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Kathmandu University School of Medical Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Karmacharya', 'Affiliation': 'Kathmandu University School of Medical Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Anmol', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Kathmandu University School of Medical Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Sumitra', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Kathmadnu Medical College Teaching Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Yale School of Public Health, New Haven, Connecticut, USA.'}]",Open heart,['10.1136/openhrt-2019-001236']
2673,32848185,The effects of intravenous iron supplementation on fatigue and general health in non-anemic blood donors with iron deficiency: a randomized placebo-controlled superiority trial.,"We investigated whether intravenous iron supplementation improves fatigue and general health in non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L). Of 1,487 potentially eligible participants, 203 were randomly assigned to a single intravenous dose of 800 mg iron-carboxymaltose and 202 to placebo; 393 participants completed the trial. At 6 to 8 weeks after intervention, self-rated mean fatigue scores (numeric rating scale from 1-10, primary outcome) were 3.9 ± 1.8 in the iron supplementation group and 4.0 ± 2.2 in the placebo group, showing no group difference (p = 0.819). Pre-specified subgroup analyses of gender, ferritin < 25 µg/L and fatigue ≥ 4 points, as well as exploratory analyses of lower ferritin cut-offs did not reveal any between-group differences. In terms of secondary outcomes, the mean differences were 114.2 µg/L for ferritin (95% CI 103.1-125.3) and 5.7 g/L for hemoglobin (95% CI 4.3-7.2) with significantly higher values in the iron supplementation group. No group differences were observed for different measures of general well-being and other clinical and safety outcomes. Intravenous iron supplementation compared with placebo resulted in increase of ferritin and hemoglobin levels in repeat blood donors with low iron stores, yet had no effect on fatigue and general well-being.",2020,"Intravenous iron supplementation compared with placebo resulted in increase of ferritin and hemoglobin levels in repeat blood donors with low iron stores, yet had no effect on fatigue and general well-being.","['393 participants completed the trial', 'non-anemic repeat adult blood donors with iron deficiency (ferritin\u2009≤\u200950\xa0µg/L', 'Of 1,487 potentially eligible participants, 203', 'non-anemic blood donors with iron deficiency']","['intravenous iron supplementation', 'Intravenous iron supplementation', 'placebo', 'single intravenous dose of 800\xa0mg iron-carboxymaltose']","['fatigue and general health', 'hemoglobin', 'ferritin and hemoglobin levels', 'self-rated mean fatigue scores (numeric rating scale']","[{'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1487.0,0.653698,"Intravenous iron supplementation compared with placebo resulted in increase of ferritin and hemoglobin levels in repeat blood donors with low iron stores, yet had no effect on fatigue and general well-being.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Keller', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, SRO AG Spital Langenthal, Langenthal, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'von Känel', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Culmannstrasse 8, 8091, Zurich, Switzerland. roland.vonkaenel@usz.ch.'}, {'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Hincapié', 'Affiliation': ""Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Tobias E', 'Initials': 'TE', 'LastName': 'Erlanger', 'Affiliation': 'Clinical Trial Unit, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Andina', 'Affiliation': 'Department of Hematology and Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Niederhauser', 'Affiliation': 'Interregional Blood Transfusion SRC, Bern, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Lämmle', 'Affiliation': 'Department of Hematology and Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fontana', 'Affiliation': 'Interregional Blood Transfusion SRC, Bern, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-71048-0']
2674,32848365,"Effect of Intravenous Injection of Vitamin C on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized Trial.","Purpose


In this study, the effect of intravenous vitamin C during surgery on the incidence of postoperative pulmonary complications (PPCs) in patients undergoing cardiopulmonary bypass and cardiac surgery was observed, and its protective effect on the lungs was evaluated to provide a reference for clinical medication.
Patients and Methods


Patients undergoing cardiac surgery under cardiopulmonary bypass (CPB) were selected. The patients were divided into group A and group C by random sequence. Patients in group A received intravenous vitamin C 1 g 10 minutes after induction of anesthesia, 10 minutes before cardiac reanimation and at the moment of sternal closure. Patients in group C were intravenously injected with the same volume of saline at the same time. The primary outcome was the postoperative pulmonary complication severity score. Other outcomes were the incidence of PPCs, awakening time, extubation time, length of ICU stay, length of hospital stay, adverse events, oxygenation index (PaO 2 /FiO 2 ), alveolar arterial oxygen partial pressure difference (A-aDO 2 ), dynamic lung compliance (Cd) and static lung compliance (Cs).
Results


Seventy patients completed the study. Compared to group C, the postoperative pulmonary complication score [2(2-3) vs 2(1-2);  P =0.009] and the incidence of postoperative pulmonary complications (32.43% vs 12.12%;  P  =0.043) were lower in group A. There were no significant differences in awakening time, extubation time, length of ICU stay, length of hospital stay, adverse events, PaO 2 /FiO 2 , A-aDO 2 , Cs, and Cd between the two groups ( P >0.05).
Conclusion


In summary, this small randomized trial including low-risk cardiac surgery patients shows that intravenous vitamin C may safely be administered and may be helpful to prevent PPCs after cardiac surgery.",2020,"There were no significant differences in awakening time, extubation time, length of ICU stay, length of hospital stay, adverse events, PaO 2 /FiO 2 , A-aDO 2 , Cs, and Cd between the two groups ( P >0.05).
","['low-risk cardiac surgery patients', 'Undergoing Cardiac Surgery', 'patients undergoing cardiopulmonary bypass and cardiac surgery', 'Patients', 'Seventy patients completed the study']","['cardiac surgery under cardiopulmonary bypass (CPB', 'Intravenous Injection of Vitamin C', 'intravenous vitamin C']","['awakening time, extubation time, length of ICU stay, length of hospital stay, adverse events, PaO 2 /FiO 2 , A-aDO 2 , Cs, and Cd', 'incidence of PPCs, awakening time, extubation time, length of ICU stay, length of hospital stay, adverse events, oxygenation index (PaO 2 /FiO 2 ), alveolar arterial oxygen partial pressure difference (A-aDO 2 ), dynamic lung compliance (Cd) and static lung compliance (Cs', 'Postoperative Pulmonary Complications', 'incidence of postoperative pulmonary complications', 'postoperative pulmonary complication severity score', 'postoperative pulmonary complications (PPCs', 'postoperative pulmonary complication score']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0024112', 'cui_str': 'Lung compliance'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.142326,"There were no significant differences in awakening time, extubation time, length of ICU stay, length of hospital stay, adverse events, PaO 2 /FiO 2 , A-aDO 2 , Cs, and Cd between the two groups ( P >0.05).
","[{'ForeName': 'Dongyue', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Jindong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S254150']
2675,32853691,Development and validation of screening scores of non-alcoholic fatty liver disease in middle-aged and elderly Chinese.,"AIM


Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease and also closely related to cardiometabolic disease. Its prevalence was estimated at over one-fourth in the general population in China. We aimed to develop effective score tools for detecting NAFLD.
METHODS


A total of 17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis. All participants were randomly classified into the exploratory group or the validation group. Candidate categorical variables were selected using a logistic regression model. The score points were generated according to the β-coefficients.
RESULTS


We developed the Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I), which included body mass index and waist circumference with an area under the receiver-operating characteristic curve (AUC) of 0.802 (95% CI 0.792-0.811) in the exploratory group and 0.802 (95% CI 0.793-0.812) in the validation group. We further developed the SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC of 0.852 (95% CI 0.843-0.861) in the exploratory group and 0.843 (95% CI 0.834-0.852) in the validation group. The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
CONCLUSIONS


Based on anthropometric and clinical categorical variables, our two scores are effective tools for detecting NAFLD in both this southern Chinese population and their subpopulation with normal ALT levels.",2020,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","['subjects with normal alanine aminotransferase (ALT) levels', 'middle-aged and elderly Chinese', '17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis']",[],"['Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I', 'SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",17212.0,0.0822862,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","[{'ForeName': 'Yebei', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ""Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: houxuhong@sjtu.edu.cn.""}, {'ForeName': 'Peizhu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Fusong', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Lichang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Prevention and Health Care, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: wpjia@sjtu.edu.cn.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108385']
2676,32853703,Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13 Month Follow-up.,"OBJECTIVE


To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback, NF) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.
METHOD


In a 2-site double-blind randomized clinical trial, 144 children age 7-10 with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR)>4.5 were randomized 3:2 to deliberate TBR downtraining vs. a control of equal duration, intensity, and appearance. Two early dropouts left 142 for modified intent-to-treat analysis. The control utilized pre-recorded EEGs with participant's artifacts superimposed. Treatment was programmed via internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists, 93.2% by NF expert monitor. Primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated.
RESULTS


Blinding was excellent. While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up). Responders (CGI-I=1-2) were 61% of NF and 54% of Controls (p=.36). Adverse events were distributed proportionally between treatments. 13-month follow-up found nonsignificant improvement from treatment end for NF (d=0.1), with mild deterioration for controls (d= -0.07). NF required significantly less medication at follow-up (p=.012).
CONCLUSION


This study does not support a specific effect of deliberate TBR NF at either treatment end or 13-month follow-up. Participants will be reassessed at 25-month follow-up.",2020,"While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up).","['144 children age 7-10 with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR)>4.5', 'Attention-Deficit/Hyperactivity Disorder']","['deliberate TBR', 'Neurofeedback', 'theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback, NF', 'Placebo', 'deliberate TBR NF']","['parent- and teacher-rated inattention; analysis', 'Adverse events', 'Fidelity']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",144.0,0.256558,"While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': ''}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Barterian', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Bergman', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'C Keith', 'Initials': 'CK', 'LastName': 'Conners', 'Affiliation': ''}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Connor', 'Affiliation': ''}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Dasgupta', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'deBeus', 'Affiliation': ''}, {'ForeName': 'Teryll', 'Initials': 'T', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Hirshberg', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hollway', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kerson', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lightstone', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lofthouse', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Lubar', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'McBurnett', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Monastra', 'Affiliation': ''}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Buchan-Page', 'Affiliation': ''}, {'ForeName': 'Xueliang Jeff', 'Initials': 'XJ', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Roley-Roberts', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rhodes', 'Affiliation': ''}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Schrader', 'Affiliation': ''}, {'ForeName': 'Yubo Jeremy', 'Initials': 'YJ', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Williams', 'Affiliation': ''}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.906']
2677,32853704,A Multisite Randomized Controlled Trial Comparing the Effects of Intervention Intensity and Intervention Style on Outcomes for Young Children With Autism.,"OBJECTIVE


This randomized, multisite, intent-to-treat study tested the effects of two levels of treatment intensity (number of hours) and two treatment styles on progress of young children with autism spectrum disorder (ASD). We predicted that initial severity of developmental delay or autism symptoms would moderate the effects of intensity and style on progress in four domains: autism symptom severity, expressive communication, receptive language, and nonverbal ability.
METHOD


Eighty-seven children with ASD, mean age 23.4 months, were assigned to one of two intervention styles (naturalistic developmental-behavioral or discrete trial teaching), each delivered for either 15 or 25 hours per week of 1:1 intervention for 12 months by trained research staff. All caregivers received coaching twice monthly. Children were assessed at four timepoints. Examiners and coders were naive to treatment assignment.
RESULTS


Neither style nor intensity had main effects on the four outcome variables. In terms of moderating effects of initial severity of developmental delay and of autism symptom severity, neither moderated the effects of treatment style on progress in any of the four domains. In terms of treatment intensity, initial severity moderated effect of treatment intensity on only one domain - change in autism symptom severity, and in a secondary analysis, this effect was found in only one site.
CONCLUSION


Neither treatment style or intensity had overall effects on child outcomes in the four domains examined. Initial severity did not predict better response to one intervention style than another. We found very limited evidence that initial severity predicted better response to 25 versus 15 hours per week of intervention in the domains studied.",2020,"In terms of treatment intensity, initial severity moderated effect of treatment intensity on only one domain - change in autism symptom severity, and in a secondary analysis, this effect was found in only one site.
","['Young Children With Autism', 'Eighty-seven children with ASD, mean age 23.4 months', 'young children with autism spectrum disorder (ASD']","['Intervention Intensity and Intervention Style', 'intervention styles (naturalistic developmental-behavioral or discrete trial teaching']","['autism symptom severity, expressive communication, receptive language, and nonverbal ability']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",87.0,0.0524982,"In terms of treatment intensity, initial severity moderated effect of treatment intensity on only one domain - change in autism symptom severity, and in a secondary analysis, this effect was found in only one site.
","[{'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yoder', 'Affiliation': ''}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': ''}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Warren', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McEachin', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Greenson', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gardner', 'Affiliation': ''}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': ''}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Whelan', 'Affiliation': ''}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.06.013']
2678,32848373,Effects of Arch Support Insoles on Single- and Dual-Task Gait Performance Among Community-Dwelling Older Adults.,"Purpose


To explore the immediate and prolonged effects of arch support insoles on single- and dual-task gait performance among community-dwelling older adults.
Methods


Twenty women performed single- and dual-task walking for 10 m at self-selected comfortable and fast paces while performing serial subtractions (cognitive interference) or carrying a tray (motor interference). Spatiotemporal gait parameters were measured and compared with measurements without arch support immediately after the insertion of the insoles and at 1-week follow-up.
Results


Some effects were noted, with small-to-medium effect sizes. During comfortable-paced single-task walking, stride length and walk ratio (step length/cadence) increased after arch support use. During comfortable-paced motor dual-task walking, arch support use increased cadence, stride length, and speed and decreased dual-task costs (DTCs) on cadence and speed. During fast-paced motor dual-task walking, cadence increased and the DTC on cadence decreased after arch support use at the 1-week follow-up. During comfortable-paced cognitive dual-task walking, cadence increased and the walk ratio decreased following arch support use. At the 1-week follow-up, DTCs on cadence reduced, but those on stride length and speed increased. During fast-paced cognitive dual-task walking, the speed and stride length demonstrated immediate decreases followed by increases at the 1-week follow-up.
Conclusion


The study results indicate that the use of arch support improves single- and motor dual-task gait performance, which may contribute to gait and balance training in older adults.",2020,"During comfortable-paced cognitive dual-task walking, cadence increased and the walk ratio decreased following arch support use.","['older adults', 'Community-Dwelling Older Adults', 'community-dwelling older adults']",['single- and dual-task walking for 10 m at self-selected comfortable and fast paces while performing serial subtractions (cognitive interference) or carrying a tray (motor interference'],"['Single- and Dual-Task Gait Performance', 'Spatiotemporal gait parameters', 'walk ratio', 'single- and motor dual-task gait performance', 'cadence, stride length, and speed and decreased dual-task costs (DTCs) on cadence and speed', 'single- and dual-task gait performance', 'stride length and walk ratio (step length/cadence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0184054', 'cui_str': 'Tray'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0427126', 'cui_str': 'Step length'}]",20.0,0.0148865,"During comfortable-paced cognitive dual-task walking, cadence increased and the walk ratio decreased following arch support use.","[{'ForeName': 'Hsien-Te', 'Initials': 'HT', 'LastName': 'Peng', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Chueh-Ho', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Chen-Yi', 'Initials': 'CY', 'LastName': 'Song', 'Affiliation': 'Department of Long-Term Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Clinical interventions in aging,['10.2147/CIA.S254474']
2679,32848377,"The Effect of Mindfulness-Based Stress Reduction (MBSR) on Depression, Cognition, and Immunity in Mild Cognitive Impairment: A Pilot Feasibility Study.","Background


Mindfulness-based programs have shown a promising effect on several health factors associated with increased risk of dementia and the conversion from mild cognitive impairment (MCI) to dementia such as depression, stress, cognitive decline, immune system and brain structural and functional changes. Studies on mindfulness in MCI subjects are sparse and frequently lack control intervention groups.
Objective


To determine the feasibility and the effect of mindfulness-based stress reduction (MBSR) practice on depression, cognition and immunity in MCI compared to cognitive training.
Methods


Twenty-eight MCI subjects were randomly assigned to two groups. MBSR group underwent 8-week MBSR program. Control group underwent 8-week cognitive training. Their cognitive and immunological profiles and level of depressive symptoms were examined at baseline, after each 8-week intervention (visit 2, V2) and six months after each intervention (visit 3, V3). MBSR participants completed feasibility questionnaire at V2.
Results


Twenty MCI patients completed the study (MBSR group n=12, control group n=8). MBSR group showed significant reduction in depressive symptoms at both V2 (p=0.03) and V3 (p=0.0461) compared to the baseline. There was a minimal effect on cognition - a group comparison analysis showed better psychomotor speed in the MBSR group compared to the control group at V2 (p=0.0493) but not at V3. There was a detectable change in immunological profiles in both groups, more pronounced in the MBSR group. Participants checked only positive/neutral answers concerning the attractivity/length of MBSR intervention. More severe cognitive decline (PVLT≤36) was associated with the lower adherence to home practice.
Conclusion


MBSR is well-accepted potentially promising intervention with positive effect on cognition, depressive symptoms and immunological profile.",2020,MBSR group showed significant reduction in depressive symptoms at both V2 (p=0.03) and V3 (p=0.0461) compared to the baseline.,"['Methods\n\n\nTwenty-eight MCI subjects', 'Mild Cognitive Impairment']","['Mindfulness-Based Stress Reduction (MBSR', '8-week cognitive training', 'MBSR', 'mindfulness-based stress reduction (MBSR) practice']","['immunological profiles', 'cognitive and immunological profiles and level of depressive symptoms', 'depressive symptoms', 'psychomotor speed', 'attractivity/length of MBSR intervention', 'Depression, Cognition, and Immunity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}]",28.0,0.017431,MBSR group showed significant reduction in depressive symptoms at both V2 (p=0.03) and V3 (p=0.0461) compared to the baseline.,"[{'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Marciniak', 'Affiliation': ""International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Rastislav', 'Initials': 'R', 'LastName': 'Šumec', 'Affiliation': ""International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vyhnálek', 'Affiliation': ""International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Bendíčková', 'Affiliation': ""Center of Translational Medicine, International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lázničková', 'Affiliation': ""Center of Translational Medicine, International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Forte', 'Affiliation': ""Center of Translational Medicine, International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Jeleník', 'Affiliation': ""International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Římalová', 'Affiliation': ""International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frič', 'Affiliation': ""Center of Translational Medicine, International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Hort', 'Affiliation': ""International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Kateřina', 'Initials': 'K', 'LastName': 'Sheardová', 'Affiliation': ""International Clinical Research Center (ICRC), St. Anne's University Hospital, Brno, Czech Republic.""}]",Clinical interventions in aging,['10.2147/CIA.S249196']
2680,32848379,Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD.,"Introduction


Long-acting β 2 -agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are established maintenance bronchodilator treatments for chronic obstructive pulmonary disease (COPD) with the potential to increase heart rate (HR) and impact blood pressure (BP). While previous studies indicate that HR and BP are not negatively influenced by tiotropium or olodaterol monotherapy, the effect of tiotropium/olodaterol has not been evaluated. We report a post hoc analysis of the effect of dual bronchodilation with tiotropium/olodaterol versus monocomponents on HR and BP in patients with moderate-to-very-severe COPD included in the large TONADO ®  study.
Methods


The TONADO ®  trials (1237.5 [NCT01431274] and 1237.6 [NCT01431287]) were two replicate, randomized, double-blind, parallel-group, 52-week, Phase III trials that compared tiotropium/olodaterol (5/5 μg and 2.5/5 μg) with tiotropium (5 μg and 2.5 μg) and olodaterol (5 μg) in patients with moderate-to-very-severe COPD. Patients with cardiovascular comorbidities were included. Changes in HR and systolic/diastolic BP were measured before and after dosing with the study medication at each visit (baseline, Week 12, Week 24 and Week 52).
Results


Overall, 3,100 patients were included in this analysis. Over 52 weeks, small changes from baseline in mean HR (<2 beats per minute [bpm]) and small changes from pre- to post-dose (<1 bpm) were evident at different time points. There was a non-significant increase from baseline in mean diastolic and systolic BP (<2 mmHg) observed over 52 weeks of treatment. The short-term (1 hour pre- to 1 hour post-dose) mean changes in systolic and diastolic BP over 52 weeks in the tiotropium/olodaterol 5/5 µg group were comparable with those observed for the monocomponents at all time points.
Conclusion


There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents. This supports the already demonstrated cardiovascular safety profile of tiotropium/olodaterol as long-acting maintenance bronchodilator treatment for COPD, including patients with cardiovascular comorbidities.",2020,There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents.,"['Patients with cardiovascular comorbidities were included', '3,100 patients were included in this analysis', 'patients with moderate-to-very-severe COPD included in the large TONADO ®  study', 'patients with moderate-to-very-severe COPD', 'Patients with Moderate-to-Very-Severe COPD', 'chronic obstructive pulmonary disease (COPD', 'patients with cardiovascular comorbidities']","['tiotropium/olodaterol', 'tiotropium/olodaterol versus monocomponents', 'tiotropium', 'Long-acting β 2 -agonists (LABAs) and long-acting muscarinic antagonists (LAMAs', 'Tiotropium/Olodaterol']","['systolic and diastolic BP', 'HR or BP', 'HR and BP', 'Changes in HR and systolic/diastolic BP', 'mean diastolic and systolic BP', 'Long-Term Heart Rate and Blood Pressure', 'heart rate (HR) and impact blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0999593', 'cui_str': 'Lama'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",3100.0,0.259105,There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Andreas', 'Affiliation': 'Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Lorcan', 'Initials': 'L', 'LastName': 'McGarvey', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bothner', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trampisch', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Matjaz', 'Initials': 'M', 'LastName': 'Fležar', 'Affiliation': 'Klinika Golnik, Golnik, Slovenia.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alter', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Marburg, Germany, Member of the German Center for Lung Research (DZL).'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S246348']
2681,32848381,A Post Hoc Holter ECG Analysis of Olodaterol and Formoterol in Moderate-to-Very-Severe COPD.,"Background


Patients with chronic obstructive pulmonary disease (COPD) are at risk of developing cardiac arrhythmias and elevated heart rate. A theoretical mechanistic association based on the interaction of long-acting β 2 -agonists (LABAs) with adrenoreceptors in the heart and vasculature is assumed as a potential class-related risk. Therefore, we performed a pooled analysis of Holter electrocardiogram (ECG) data from four 48-week, randomized, double-blind, placebo-controlled, parallel-group, Phase III clinical trials evaluating olodaterol (5 μg or 10 μg) or formoterol (12 µg) versus placebo.
Methods


We analyzed Holter ECG data from a representative subset of 775 patients with Global Initiative for Chronic Obstructive Lung Disease stage 2-4 COPD from four studies (1222.11-14) assessing olodaterol (5 μg and 10 μg) and formoterol (12 µg) versus placebo.
Results


No statistically significant (P>0.3) or clinically relevant differences in the shift from baseline of premature supraventricular or ventricular beats were observed among the active treatment and the placebo groups. Minor and transient differences were observed in the adjusted mean heart rate from baseline during treatment in all groups. There was a numerically small but statistically significant increase for formoterol at Week 24, olodaterol 5 μg at Weeks 12 and 40, and olodaterol 10 μg at Week 40 (all less than 3.0 beats per minute). Mean heart rates returned to a statistically non-significant change at Week 48 for all treatment groups. No increase in major adverse cardiovascular events was observed.
Conclusion


Treatment with olodaterol or formoterol is not associated with arrhythmias or a persistent increase in heart rate as assessed by Holter ECG in patients with COPD.
Trial Registration


ClinicalTrials.gov identifiers: NCT00782210 (1222.11); NCT00782509 (1222.12); NCT00793624 (1222.13); NCT00796653 (1222.14).",2020,"Conclusion


Treatment with olodaterol or formoterol is not associated with arrhythmias or a persistent increase in heart rate as assessed by Holter ECG in patients with COPD.
","['\n\n\nPatients with chronic obstructive pulmonary disease (COPD', '775 patients with Global Initiative for Chronic Obstructive Lung Disease stage 2-4 COPD from four studies (1222.11-14) assessing olodaterol (5 μg and 10 μg) and formoterol (12 µg) versus', 'patients with COPD', 'Moderate-to-Very-Severe COPD']","['olodaterol or formoterol', 'placebo', 'formoterol']","['adjusted mean heart rate', 'premature supraventricular or ventricular beats', 'major adverse cardiovascular events', 'heart rate', 'Mean heart rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",775.0,0.606972,"Conclusion


Treatment with olodaterol or formoterol is not associated with arrhythmias or a persistent increase in heart rate as assessed by Holter ECG in patients with COPD.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Andreas', 'Affiliation': 'Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bothner', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Kloer', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trampisch', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alter', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Marburg, Germany, Member of the German Center for Lung Research (DZL).'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S246353']
2682,31349876,Disease interception with interleukin-17 inhibition in high-risk psoriasis patients with subclinical joint inflammation-data from the prospective IVEPSA study.,"BACKGROUND


A specific subset of psoriasis patients is characterized by subclinical inflammatory changes. These patients frequently present with arthralgia and have a higher risk to develop psoriatic arthritis (PsA). We hypothesized that IL-17A inhibition in this subset of patients can intercept the link between skin and joint disease and resolves pain and inflammatory changes.
METHODS


Psoriasis, but no PsA, patients were included in the open prospective exploratory Interception in very early PsA (IVEPSA) study. Patients had to have nail or scalp involvement or a high psoriasis area severity index (PASI) (> 6) as well as inflammatory or erosive changes in MRI or CT. Patients received treatment with the anti-interleukin (IL)-17A antibody secukinumab over 24 weeks. Clinical assessments of skin and joint disease were done at baseline and after 12 and 24 weeks, MRI and CT at baseline and after 24 weeks.
RESULTS


Twenty patients were included, 85% of them reporting arthralgia and 40% had tender joints at the examination. Eighty-three percent had at least one inflammatory lesion in the MRI, most of them synovitis/enthesitis. Skin disease (PASI: p < 0.002; BSA: p < 0.003) and arthralgia (VAS pain: p < 0.003) significantly improved after 24 weeks. Total PsAMRIS (p = 0.005) and synovitis subscore (p = 0.008) also significantly improved. Erosions and enthesiophytes did not progress, while bone mass in the distal radius significantly (p = 0.020) increased after 24 weeks.
CONCLUSIONS


These data suggest that very early disease interception in PsA is possible leading to a comprehensive decline in skin symptoms, pain, and subclinical inflammation. IVEPSA therefore provides rationale for future early interventions with the concept to prevent the onset of PsA in high-risk individuals.
TRIAL REGISTRATION


Trial registry name PSARTROS; trial registry number: NCT02483234; June 26, 2015.",2019,Total PsAMRIS (p = 0.005) and synovitis subscore (p = 0.008) also significantly improved.,"['Psoriasis, but no PsA, patients were included in the open prospective exploratory Interception in very early PsA (IVEPSA) study', 'psoriasis patients', 'Skin disease (PASI', 'Twenty patients were included, 85% of them reporting arthralgia and 40% had tender joints at the examination', 'Patients had to have nail or scalp involvement or a high psoriasis area severity index (PASI) (>\u20096) as well as inflammatory or erosive changes in MRI or CT', 'high-risk psoriasis patients with subclinical joint inflammation-data from the prospective IVEPSA study']","['anti-interleukin (IL)-17A antibody secukinumab', 'IVEPSA']","['synovitis subscore', 'Total PsAMRIS', 'arthralgia (VAS pain']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}]","[{'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]","[{'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",20.0,0.105433,Total PsAMRIS (p = 0.005) and synovitis subscore (p = 0.008) also significantly improved.,"[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kampylafka', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simon', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': ""d'Oliveira"", 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Linz', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Lerchen', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Englbrecht', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Rech', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Kleyer', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sticherling', 'Affiliation': 'Department of Dermatology, Friedrich-Alexander University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schett', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany. georg.schett@uk-erlangen.de.'}, {'ForeName': 'Axel J', 'Initials': 'AJ', 'LastName': 'Hueber', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nurnberg (FAU) and Universitaetsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-019-1957-0']
2683,31481084,"Associations between biomarkers of bone and cartilage turnover, gender, pain categories and radiographic severity in knee osteoarthritis.","BACKGROUND


Excessive cartilage degradation is a known characteristic of osteoarthritis (OA). Biochemical markers, such as uCTX-II, have been shown to be associated with disease severity, yet the tissue origin of CTX-II has been disputed. This analysis investigates the association between OA knee joints at different radiographic stages and pain categories with levels of uCTX-II and biomarkers of bone resorption and formation.
METHODS


Baseline data of two randomised clinical trials (NCT00486434 and NCT00704847) in patients with radiographic OA and presence of pain were analysed post hoc. A subgroup with available urine samples and evaluable radiographs for both knees (N = 1241) was analysed. Urine CTX-I, urine CTX-II and serum osteocalcin were analysed for associations with combined Kellgren-Lawrence (KL) scores, gender and pain for both knees to assess the contribution of joints at different stages.
RESULTS


Pain, BMI, age, gender and KL grade were all significantly associated with uCTX-II. The association between pain and CTX-II appeared to be driven by weight-bearing pain. The level of uCTX-II incrementally increased with higher radiographic severity of each knee. Levels of bone markers CTX-I and osteocalcin were both significantly associated with BMI and gender, but neither were associated with radiographic severity. Biomarker levels between male or female groups of identical KL scores were found to be higher in females compared to males in some but not all KL score groups.
CONCLUSIONS


These results indicate that levels of uCTX-II are independently associated with radiographic severity of OA and pain intensity. CTX-II was associated with weight-bearing pain, but not non-weight-bearing pain, independent of co-variates. Bilateral OA knee joints appear to contribute to uCTX-II levels in an incremental manner according to radiographic severity of single joints. The data suggest that biomarker differences between genders should be taken into account when evaluating these markers in the context of structural features of OA.",2019,"Levels of bone markers CTX-I and osteocalcin were both significantly associated with BMI and gender, but neither were associated with radiographic severity.","['knee osteoarthritis', 'patients with radiographic OA and presence of pain were analysed post hoc']",[],"['Levels of bone markers CTX-I and osteocalcin', 'Urine CTX-I, urine CTX-II and serum osteocalcin', 'Biomarker levels', 'radiographic severity of OA and pain intensity', 'bone and cartilage turnover, gender, pain categories and radiographic severity', 'Pain, BMI, age, gender and KL grade']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0179498,"Levels of bone markers CTX-I and osteocalcin were both significantly associated with BMI and gender, but neither were associated with radiographic severity.","[{'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'Nordic Bioscience Clinical Development, Herlev Hovedgade 82, DK2730, Herlev, Denmark. abi@nordicbioscience.com.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Byrjalsen', 'Affiliation': 'Nordic Bioscience Clinical Development, Herlev Hovedgade 82, DK2730, Herlev, Denmark.'}, {'ForeName': 'Anne-Christine', 'Initials': 'AC', 'LastName': 'Bay-Jensen', 'Affiliation': 'Nordic Bioscience Biomarkers and Research, Herlev Hovedgade 207, DK2730, Herlev, Denmark.'}, {'ForeName': 'Jeppe Ragnar', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'Nordic Bioscience Clinical Development, Herlev Hovedgade 82, DK2730, Herlev, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Christiansen', 'Affiliation': 'Nordic Bioscience A/S, Herlev Hovedgade 207, DK2730, Herlev, Denmark.'}, {'ForeName': 'Bente Juel', 'Initials': 'BJ', 'LastName': 'Riis', 'Affiliation': 'Nordic Bioscience A/S, Herlev Hovedgade 207, DK2730, Herlev, Denmark.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience Biomarkers and Research, Herlev Hovedgade 207, DK2730, Herlev, Denmark.'}]",Arthritis research & therapy,['10.1186/s13075-019-1987-7']
2684,31807723,The effect of Myo-inositol on sperm parameters and pregnancy rate in oligoasthenospermic men treated with IUI: A randomized clinical trial.,"Background


In about 40% of the couples, the cause of infertility problems is attributed to men because of low sperm production and disturbed motility of sperm. Pieces of evidence show that Myo-inositol has a potential role for the treatment of sperm morphology and male fertility.
Objective


This study aimed to determine the effect of Myo-inositol on the sperm parameters and fertility rate in patients with oligoasthenospermia treated by intrauterine insemination (IUI).
Materials and Methods


This study was a randomized clinical trial conducted on 37 patients with oligoasthenospermia treated by IUI during 2016-2017. In this study, the patients were randomly divided into two groups of oligoasthenospermia treated with (Case group) and without Myo-inositol (Control group). The case group received 0.5 ml of Myo-inositol with a concentration of 2 mg/ml and incubated at 37°C incubator for 2 hr, but the control group had no interventions.
Results


The results of this study showed that although there was no significant difference in sperm parameters including sperm motility and concentration before processing with Myo-inositol in the case group, but there was a significant increase in sperm motility during the treatment with Myo-inositol. The therapeutic effect of this method was confirmed on induction of pregnancy in 18% of the treated patients, in such a way that was about twice greater than those who did not receive the drug.
Conclusion


According to the results of this study, the use of Myo-inositol is efficient enough to change sperm parameters to increase the chance of fertility.",2019,"The therapeutic effect of this method was confirmed on induction of pregnancy in 18% of the treated patients, in such a way that was about twice greater than those who did not receive the drug.
","['patients with oligoasthenospermia treated by intrauterine insemination (IUI', 'oligoasthenospermic men treated with IUI', '37 patients with oligoasthenospermia treated by IUI during 2016-2017']","['Myo-inositol', 'control group had no interventions', 'oligoasthenospermia treated with (Case group) and without Myo-inositol (Control group']","['sperm parameters and pregnancy rate', 'sperm parameters including sperm motility and concentration before processing with Myo-inositol', 'sperm parameters and fertility rate', 'induction of pregnancy', 'sperm motility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",37.0,0.0307741,"The therapeutic effect of this method was confirmed on induction of pregnancy in 18% of the treated patients, in such a way that was about twice greater than those who did not receive the drug.
","[{'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Shahid Akbar Abadi Hospital Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Fatemehsadat', 'Initials': 'F', 'LastName': 'Amjadi', 'Affiliation': 'Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh', 'Initials': 'S', 'LastName': 'Masoumeh Ghazi Mirsaeed', 'Affiliation': 'Shahid Akbar Abadi Hospital Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Robabeh', 'Initials': 'R', 'LastName': 'Mohammad Beigi', 'Affiliation': 'Shahid Akbar Abadi Hospital Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Ghasemi', 'Affiliation': 'Shahid Akbar Abadi Hospital Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Moradi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh', 'Initials': 'S', 'LastName': 'Tahereh Ghazi Mirsaeed', 'Affiliation': 'Shahid Akbar Abadi Hospital Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i10.5296']
2685,31807724,Self-compassion training and psychological well-being of infertile female.,"Background


The empowerment of psychological well-being is an important and fundamental issue among infertile females.
Objective


The present study investigates the effect of teaching self-compassion on the psychological well-being of initial infertile women.
Materials and Methods


In this cross-sectional, quasi-experimental study with pre-test and post-test, 32 infertile women who were referred to the Yazd Reproductive Sciences Institute during 2016-2017 were enrolled. The participants were randomly divided in two groups as control and experiment (n = 16/each). The participants only in the experimental group received 8 sessions of 90 min training (Self-Compassion Training). Ryff's psychological well-being questionnaire was applied (reliability coefficient = 0.82) and covariance analysis statistical test was used to test the research hypothesis.
Results


There was a significant difference between the estimated mean scores for improving the psychological well-being of the participants in the experiment and control groups (p = 0.007), and the difference indicates that 72.7% of the covariance of the post-test scores is due to self-compassion intervention. Therefore, the intervention of self-compassion training affects the improvement of psychological well-being among infertile women. Also, the pre-test variable is significant with the effect of 94.2% (p = 0.006).
Conclusion


The findings showed that teaching self-compassion to initial infertile women has an effect on their psychological well-being.",2019,"There was a significant difference between the estimated mean scores for improving the psychological well-being of the participants in the experiment and control groups (p = 0.007), and the difference indicates that 72.7% of the covariance of the post-test scores is due to self-compassion intervention.","['infertile females', 'infertile women', 'initial infertile women', 'infertile female', '32 infertile women who were referred to the Yazd Reproductive Sciences Institute during 2016-2017 were enrolled']","['Self-compassion training', 'teaching self-compassion']",[],"[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],32.0,0.0175982,"There was a significant difference between the estimated mean scores for improving the psychological well-being of the participants in the experiment and control groups (p = 0.007), and the difference indicates that 72.7% of the covariance of the post-test scores is due to self-compassion intervention.","[{'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Alireza Afshani', 'Affiliation': 'Social Welfare Department, Social Sciences Faculty, Yazd University, Yazd, Iran.'}, {'ForeName': 'Azade', 'Initials': 'A', 'LastName': 'Abooei', 'Affiliation': 'Islamic Azad University, Yazd Branch, Yazd, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohamad Abdoli', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v17i10.5300']
2686,32851775,Improving Mental Health and Well-Being through Informal Mindfulness Practices: An Intervention Study.,"BACKGROUND


Mindfulness-based programs have been shown to be effective in reducing stress, anxiety, and depression symptoms, and enhancing well-being. However, it remains unclear whether longer formal mindfulness practices are necessary to obtain such results. We therefore aimed to assess the effectiveness of a program (FOVEA, 8 weeks, 2h/week) which was only based on brief and informal practices.
METHODS


Using a switching replication design, participants (N = 139) were assigned to a FOVEA or a wait-list group, and completed the following self-report questionnaires online at three time points: perceived stress, anxiety, depression, satisfaction with life (dependent variables), and mindfulness (mediating variable). They also completed a daily practice diary.
RESULTS


Relative to the wait-list group, FOVEA participants showed significantly reduced perceived stress, anxiety, and depression, and increased satisfaction with life. These changes were completely mediated by increased mindfulness, and were maintained 2.5 months after the end of the program. The effect sizes were moderate to large.
CONCLUSIONS


These results underline the potential benefits of a mindfulness informal practices program for the general population. This type of program could constitute a first step towards more formal practices once the motivation to practice has been enhanced by the perceived benefits of brief practices.",2020,"These changes were completely mediated by increased mindfulness, and were maintained 2.5 months after the end of the program.",['participants (N\xa0=\xa0139'],"['FOVEA or a wait-list group, and completed the following self-report questionnaires online']","['perceived stress,\xa0anxiety, and depression, and increased satisfaction with life', 'stress, anxiety, depression, satisfaction with life']","[{'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",139.0,0.0325951,"These changes were completely mediated by increased mindfulness, and were maintained 2.5 months after the end of the program.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shankland', 'Affiliation': 'Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Tessier', 'Affiliation': 'Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Strub', 'Affiliation': 'Grenoble Ecole de Management, Grenoble, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Gauchet', 'Affiliation': 'Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Baeyens', 'Affiliation': 'Université Grenoble Alpes, Grenoble, France.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12216']
2687,32851807,Patient-reported outcomes from the investigational device exemption study of the Tablo hemodialysis system.,"INTRODUCTION


We recently completed an Investigational Device Exemption (IDE) study in which 30 patients were enrolled (13 patients previously on home hemodialysis (HHD) and 17 patients new to HHD) and treated with the Tablo Hemodialysis System (Outset Medical, Inc., San Jose, CA) for 8 weeks in-center and 8 weeks in-home with an interim 2-4 week transition period for home training.
METHODS


In addition to assessments of urea kinetics, events related to safety, and operational issues (e.g., alarm resolution), we obtained data on several parameters of health-related quality of life, including time to recovery (TTR), the EQ-5D-5L (a well-validated measure of general health status), and the quality of sleep and related symptoms, to further assess the safety of HHD with Tablo. We compared results obtained during the in-center and in-home phases of the trial.
RESULTS


Twenty-eight of 30 patients (93%) completed all trial periods. Adherence to the prescribed four treatments per week schedule was 96% in-center and 99% in-home. Median TTR was 1.5 hours (10th, 90th percentile range 0.17 to 12, mean TTR 3.68 ± 5.88 hours) during the in-center and 2 hours (10th, 90th percentile range 0 to 6.0, mean TTR 3.04 ± 5.14 hours) during the at-home phase (Wilcoxon signed rank p = 0.57). Median index values on the EQ-5D-5L were similar during the in-center (0.832, 10th, 90th percentile range 0.617 to 1, mean 0.817 ± 0.165) and in-home (0.826, 10th, 90th percentile range 0.603 to 1, mean 0.821 ± 0.163) trial phases (Wilcoxon signed rank p = 0.36). Patients reported feeling alert or well-rested with little difficulty falling or staying asleep or feeling tired and worn out when using Tablo in either environment.
CONCLUSION


When using Tablo in-home, patients reported similar TTR, general health status, and sleep quality and related symptoms compared to using Tablo in-center. (294 words).",2020,"Median index values on the EQ-5D-5L were similar during the in-center (0.832, 10th, 90th percentile range 0.617 to 1, mean 0.817 ± 0.165) and in-home (0.826, 10th, 90th percentile range 0.603 to 1, mean 0.821 ± 0.163) trial phases (Wilcoxon signed rank p = 0.36).","['30 patients were enrolled (13 patients previously on home hemodialysis (HHD) and 17 patients new to HHD) and treated with the Tablo Hemodialysis System (Outset Medical, Inc., San Jose, CA) for 8\u2009weeks in-center and 8\u2009weeks in-home with an interim 2-4\u2009week transition period for home training', 'Twenty-eight of 30 patients (93%) completed all trial periods']",[],"['urea kinetics, events related to safety, and operational issues (e.g., alarm resolution', 'several parameters of health-related quality of life, including time to recovery (TTR), the EQ-5D-5L (a well-validated measure of general health status', 'quality of sleep and related symptoms', 'Median index values', 'Median TTR', 'similar TTR, general health status, and sleep quality and related symptoms', 'feeling alert or well-rested with little difficulty falling or staying asleep or feeling tired']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019008', 'cui_str': 'Home Hemodialysis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085106', 'cui_str': 'Familial benign pemphigus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0849970', 'cui_str': 'Tired'}]",30.0,0.0237693,"Median index values on the EQ-5D-5L were similar during the in-center (0.832, 10th, 90th percentile range 0.617 to 1, mean 0.817 ± 0.165) and in-home (0.826, 10th, 90th percentile range 0.603 to 1, mean 0.821 ± 0.163) trial phases (Wilcoxon signed rank p = 0.36).","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Alvarez', 'Affiliation': 'Palo Alto Medical Foundation, Palo Alto, California, USA.'}, {'ForeName': 'Troy J', 'Initials': 'TJ', 'LastName': 'Plumb', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Prichard', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aragon', 'Affiliation': 'Outset Medical, Inc., San Jose, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12869']
2688,32851876,Variants of opioid genes and response to treatment of opioid use disorder with buprenorphine-naloxone versus extended-release naltrexone in Caucasians.,"BACKGROUND


Sublingual buprenorphine-naloxone (BUP-NX), an FDA-approved treatment for opioid use disorder (OUD), combines buprenorphine (a partial mu/kappa agonist) with naloxone (a mu/ kappa antagonist). Extended-release injection naltrexone (XR-NTX; a mu receptor antagonist and kappa receptor partial agonist) is also an FDA-approved treatment for OUD. However, while some patients respond well to these medications, many others leave treatment and relapse.
OBJECTIVES


Determine whether gene variants in the opioid gene system are associated with better or worse treatment response.
METHODS


In a 24-week, multisite, randomized, comparative effectiveness trial of daily, sublingual self-administration of BUP-NX versus monthly injection of XR-NTX conducted in the National Drug Abuse Clinical Trials Network, DNA was collected and four opioid gene variants were evaluated: (1) mu opioid receptor 118A>G; (2) 68-bp repeat in prodynorphin; (3) prodynorphin SNP rs910080; and (4) kappa opioid receptor SNP rs6473797. In non-Hispanic Caucasians ( N  = 334), two outcomes measures were assessed: received first dose (yes/no) and received last dose (yes/no). Separate logistic regressions were used to each model outcome measure as a function of treatment (XR-NTX vs BUP-NX), each gene variant, and their interaction.
RESULTS


There were no significant main effects of gene variant on receiving first dose or last dose. There were also no significant gene variant by treatment interactions.
CONCLUSIONS


The outcome of treatment of OUD with medications is likely a complex function of multiple factors, including environmental, psychosocial, and possibly genetic, such that major effects of genetic variants may be unlikely.",2020,There were no significant main effects of gene variant on receiving first dose or last dose.,['Caucasians'],"['buprenorphine-naloxone (BUP-NX', 'naltrexone (XR-NTX', 'buprenorphine-naloxone', 'sublingual self-administration of BUP-NX versus monthly injection of XR-NTX', 'naloxone', 'buprenorphine']",[],"[{'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]",[],,0.0209085,There were no significant main effects of gene variant on receiving first dose or last dose.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Randesi', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute, Columbia University Medical Center , New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Levran', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'Jurg', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Laboratory of Statistical Genetics, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health , New York, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Division of Mental Health Data Science, New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Mary Jeanne', 'Initials': 'MJ', 'LastName': 'Kreek', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2020.1797064']
2689,32851871,A 12-Week Multi-Modal Exercise Program: Feasibility of Combined Exercise and Simplified 8-Style Tai Chi Following Lung Cancer Surgery.,"OBJECTIVE


To assess the feasibility, safety, and preliminary effect of a 12-week multi-modal rehabilitation program targeted at improving health-related quality of life and physical activity levels of patients with lung cancer following treatment.
METHODS


Patients with stage I to IIIA non-small cell lung cancer were included 6 to 12 weeks following completion of treatment. The intervention comprised of aerobic exercise (brisk walking), resistance training and 8-style Tai Chi. The 12-week program included 2 supervised center-based sessions per week of 90 minutes duration and home-based exercise. The primary outcomes were the feasibility and safety of the intervention. Secondary outcomes (assessed pre and post program) were physical and patient-reported outcomes.
RESULTS


Seventy-eight patients were approached during the 6-month recruitment period and 17 (22%) consented to the study. Eight participants (47%) met the definition of adherence to the program (attending at least 70% of supervised sessions). No serious adverse events occurred. A significant reduction in anxiety and depression was observed post-program. In addition, improvements in respiratory function, sleep quality, and some health-related quality of life domains were observed post-program. There were no significant differences in functional capacity or physical activity levels.
CONCLUSION


This multi-modal exercise training program was safe, although the feasibility of the program in its current state is not supported given the low consent rate and low adherence to the intervention.",2020,"There were no significant differences in functional capacity or physical activity levels.
","['Patients with stage I to IIIA non-small cell lung cancer', 'patients with lung cancer following treatment', 'Lung Cancer Surgery', 'Seventy-eight patients were approached during the 6-month recruitment period and 17 (22%) consented to the study']","['supervised center-based sessions per week of 90\u2009minutes duration and home-based exercise', 'multi-modal rehabilitation program', 'Combined Exercise and Simplified 8-Style Tai Chi', 'aerobic exercise (brisk walking), resistance training and 8-style Tai Chi']","['respiratory function, sleep quality, and some health-related quality of life domains', 'health-related quality of life and physical activity levels', 'feasibility and safety', 'functional capacity or physical activity levels', 'anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",78.0,0.0423315,"There were no significant differences in functional capacity or physical activity levels.
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Yuejiao', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Qirui', 'Initials': 'Q', 'LastName': 'Cong', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Granger', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Edbrooke', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}]",Integrative cancer therapies,['10.1177/1534735420952887']
2690,32851885,Development and Validation of Prognostic Nomograms to Predict Overall and Cancer-Specific Survival for Patients with Adenocarcinoma of the Urinary Bladder: A Population-Based Study.,"BACKGROUNDS


Adenocarcinoma of the bladder (ACB) rarely occurs but is associated with poor outcome. We aim to establish reliable nomograms for estimating cancer-specific survival (CSS) and overall survival (OS) of ACB patients.
METHODS


ACB patients were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015). A total of 1,149 patients were randomly divided into training cohort ( n  = 692) and validation cohort ( n  = 457). Multivariate Cox proportional hazards regression models were employed to identify independent prognostic factors. Nomograms predicting OS and CSS were constructed utilizing screened factors. The performance of nomograms was internally and externally validated by calibration curves, the receiver operating characteristic (ROC) curves, concordance index (C-index), and decision curve analysis (DCA).
RESULTS


OS nomogram incorporated age, race, histologic grade, American Joint Committee of Cancer (AJCC) stage, metastasis, surgery, chemotherapy, and tumor size. The C-indices were 0.754 (95% CI: 0.732-0.775) for training set and 0.743 (95% CI: 0.712-0.767) for validation set. Meanwhile, the calibration plots for 3- and 5-year OS displayed fine concordance between actual and predicted outcomes. In addition, higher areas under the curve (AUCs) were seen in training cohort (3-year: 0.799 vs. 0.630; 5-year: 0.797 vs. 0.648) and validation cohort (3-year: 0.802 vs. 0.662; 5-year: 0.752 vs. 0.660). Finally, DCA curves of the nomograms exhibited larger net benefits than AJCC stage. CSS nomogram showed similar results.
CONCLUSION


Our study constructed and validated nomograms with improved discriminative abilities and clinical benefits to predict the survival outcomes of ACB patients. The models might assist clinicians in optimizing therapeutic management on individual levels.",2020,The C-indices were 0.754 (95% CI: 0.732-0.775) for training set and 0.743 (95% CI: 0.712-0.767) for validation set.,"['ACB patients were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015', 'ACB patients', '1,149 patients', 'Patients with Adenocarcinoma of the Urinary Bladder']",[],"['receiver operating characteristic (ROC) curves, concordance index (C-index), and decision curve analysis (DCA', 'cancer-specific survival (CSS) and overall survival (OS']","[{'cui': 'C0279682', 'cui_str': 'Adenocarcinoma of bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037501', 'cui_str': 'Sodium Dichloroacetate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1149.0,0.0779181,The C-indices were 0.754 (95% CI: 0.732-0.775) for training set and 0.743 (95% CI: 0.712-0.767) for validation set.,"[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Yunjin', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': ""Department of Urology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Maoying', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Anyue Hengkang Hospital, Anyue County, People's Republic of China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""West China School of Medicine/West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Han', 'Affiliation': ""Department of Urology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1812776']
2691,32852352,"Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Healthy Meningococcal-Naïve Children 2-9 Years of Age: A Phase III, Randomized Study.","BACKGROUND


Invasive meningococcal disease is a major cause of meningitis in children. An investigational meningococcal (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW-TT) could offer protection against invasive meningococcal disease in this population. This phase III study assessed the immunogenicity and safety of MenACYW-TT in children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria protein CRM197 (MenACWY-CRM).
METHODS


Healthy children 2-9 years of age in the United States, including Puerto Rico, were randomized (1:1) to receive MenACYW-TT (n = 499) or MenACWY-CRM (n = 501) (NCT03077438). Meningococcal antibody titers to the 4 vaccine serogroups were measured using a serum bactericidal antibody assay with human complement (hSBA) before and at day 30 after vaccination. Noninferiority between the vaccine groups was assessed by comparing seroresponse rates (postvaccination titers ≥1:16 when prevaccination titers were <1:8, or ≥4-fold increase if prevaccination titers were ≥1:8) to the 4 serogroups at day 30. Safety was monitored.
RESULTS


The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively). Geometric mean titers for serogroups C, W, and Y were higher with MenACYW-TT than for MenACWY-CRM. Both vaccines were well-tolerated and had similar safety profiles.
CONCLUSIONS


MenACYW-TT was well-tolerated in children and achieved noninferior immune responses to MenACWY-CRM against each of the 4 vaccine serogroups.",2020,"The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively).","['children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria protein CRM197 (MenACWY-CRM', '2-9 years of age in the United States, including Puerto Rico', 'Healthy children', 'Healthy Meningococcal-Naïve Children 2-9 Years of Age', 'children']","['toxoid conjugate vaccine (MenACYW-TT', 'MenACWY-CRM', 'Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT']","['immunogenicity and safety', 'Safety and Immunogenicity', 'proportion of participants achieving seroresponse', 'tolerated', 'Meningococcal antibody titers', 'seroresponse rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0056499', 'cui_str': 'CRM197 (non-toxic variant of diphtheria toxin)'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}]","[{'cui': 'C0040555', 'cui_str': 'Toxoid'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443678', 'cui_str': 'Meningococcal antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",501.0,0.106904,"The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively).","[{'ForeName': 'Carmen I', 'Initials': 'CI', 'LastName': 'Baccarini', 'Affiliation': 'From the Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Simon', 'Affiliation': 'Baptist Health, Nicholasville, KT.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Brandon', 'Affiliation': 'California Research Foundation, San Diego, CA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'J. Lewis Research, Inc., Salt Lake City, UT.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'From the Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'From the Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002832']
2692,32852358,Prescribed Walking for Glycemic Control and Symptom Management in Patients without Diabetes Undergoing Chemotherapy.,"BACKGROUND


Hyperglycemia may potentiate symptom experiences. Exercise is a nonpharmacologic intervention that can potentially improve glycemic control and mitigate symptom experiences in patients undergoing chemotherapy for cancer.
OBJECTIVES


The primary objective was to assess the feasibility of patients engaging in a walking exercise study for 6 months. We also evaluated the effects of a prescribed walking program on glycemic control and for changes over time in the severity of pain, fatigue, depression, and sleep disturbance in patients undergoing chemotherapy for breast, lung, gynecologic, or gastrointestinal cancer.
METHODS


A randomized pilot intervention study was conducted to evaluate differences within and between a prescribed walking program intervention group and a control group. All patients were followed for 6 months, had glycosylated hemoglobin A1c (A1c) measured at enrollment and 6 months, and completed symptom questionnaires at enrollment, 3 months, and 6 months. Data were analyzed using descriptive statistics and analysis of covariance.
RESULTS


The majority of patients who enrolled completed the 6-month study. The few who withdrew expressed feeling overwhelmed. The sample was predominately non-Hispanic White female patients with breast cancer with a normal-to-slightly overweight body mass index. The intervention group had a slight decrease in A1c at 6 months. In addition, at 6 months, compared to the control group, the intervention group had significantly less sleep disturbance and depression. No other within or between group differences were found.
DISCUSSION


It is feasible for patients undergoing chemotherapy to participate in a prescribed walking program. Exercise, such as walking, may decrease hyperglycemia and symptom severity. Additional research with larger samples is warranted.",2020,"Exercise is a nonpharmacologic intervention that can potentially improve glycemic control and mitigate symptom experiences in patients undergoing chemotherapy for cancer.
","['patients undergoing chemotherapy for cancer', 'patients undergoing chemotherapy for breast, lung, gynecologic, or gastrointestinal cancer', 'patients undergoing chemotherapy to participate in a prescribed walking program', 'sample was predominately non-Hispanic White female patients with breast cancer with a normal-to-slightly overweight body mass index', 'Patients without Diabetes Undergoing Chemotherapy']","['walking program intervention', 'prescribed walking program']","['pain, fatigue, depression, and sleep disturbance', 'sleep disturbance and depression', 'hyperglycemia and symptom severity', 'glycosylated hemoglobin A1c (A1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",,0.0242007,"Exercise is a nonpharmacologic intervention that can potentially improve glycemic control and mitigate symptom experiences in patients undergoing chemotherapy for cancer.
","[{'ForeName': 'Marilyn J', 'Initials': 'MJ', 'LastName': 'Hammer', 'Affiliation': 'Director, The Phyllis F. Cantor Center for Nursing in Research and Patient Care Services, Dana-Farber Cancer Institute, Member of the Faculty, Medical Oncology, Harvard Medical School, Boston, MA, USA Professor, Barbara H. Hagan School of Nursing and Health Sciences, Molloy College, Rockville Center, NY, USA Chief Nursing Officer and Senior Vice President, Department of Nursing, The Mount Sinai Hospital, Associate Professor, Icahn School of Medicine at Mount Sinai, New York, NY, USA Professor and Vice Chair for Research, Sharon Lamb Endowed Chair in Symptom Management Research, American Cancer Society Clinical Research Professor, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Eckardt', 'Affiliation': ''}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Cartwright', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Miaskowski', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000468']
2693,32852361,Cessation of long-term cotrimoxazole prophylaxis in HIV-infected children does not alter the carriage of antimicrobial resistance genes.,"BACKGROUND


Cotrimoxazole (CTX) is a broad-spectrum antimicrobial, combining trimethoprim and sulfamethoxazole. CTX prophylaxis reduces mortality and morbidity among people living with HIV in regions with high prevalence of bacterial infections and malaria. The Antiretroviral research for Watoto (ARROW) trial evaluated the effect of stopping versus continuing CTX prophylaxis in sub-Saharan Africa.
METHODS


In this study, 72 HIV-infected Zimbabwean children, on antiretroviral therapy, provided fecal samples at 84- and 96-weeks after randomization to continue or stop CTX. DNA was extracted for whole metagenome shotgun sequencing, with sequencing reads mapped to the Comprehensive Antibiotic Resistance Database (CARD) to identify CTX and other antimicrobial resistance genes.
RESULTS


There were minimal differences in the carriage of CTX resistance genes between groups. The dfrA1 gene, conferring trimethoprim resistance, was significantly higher in the continue group (p=0.039) and the tetA(P) gene conferring resistance to tetracycline was significantly higher in the stop group (p=0.013). CTX prophylaxis has a role in shaping the resistome, however stopping prophylaxis does not decrease resistance gene abundance.
CONCLUSION


No differences were observed in resistance gene carriage between the stop and continue groups. The previously shown multi-faceted protective effects of CTX in ARROW Trial clinical outcomes are not outweighed by the risk of multi-drug resistance gene selection due to prophylaxis. These findings are reassuring, given current recommendations for long-term CTX prophylaxis among children living with HIV in sub-Saharan Africa to decrease mortality and morbidity.",2020,"The dfrA1 gene, conferring trimethoprim resistance, was significantly higher in the continue group (p=0.039) and the tetA(P) gene conferring resistance to tetracycline was significantly higher in the stop group (p=0.013).","['people living with HIV in regions with high prevalence of bacterial infections and malaria', '72 HIV-infected Zimbabwean children, on antiretroviral therapy, provided fecal samples at 84- and 96-weeks after randomization to continue or stop CTX', 'HIV-infected children']","['CTX prophylaxis', 'CTX', 'trimethoprim and sulfamethoxazole', 'Cotrimoxazole (CTX']","['carriage of antimicrobial resistance genes', 'tetA(P) gene conferring resistance to tetracycline', 'resistance gene carriage', 'mortality and morbidity', 'carriage of CTX resistance genes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0040976', 'cui_str': 'Trientine'}, {'cui': 'C0039649', 'cui_str': 'Tetracycline Resistance'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]",72.0,0.114386,"The dfrA1 gene, conferring trimethoprim resistance, was significantly higher in the continue group (p=0.039) and the tetA(P) gene conferring resistance to tetracycline was significantly higher in the stop group (p=0.013).","[{'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Francis', 'Affiliation': 'Experimental Medicine, Department of Medicine, University of British Columbia, Vancouver BC, Canada.'}, {'ForeName': 'Ethan K', 'Initials': 'EK', 'LastName': 'Gough', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore MD, USA.'}, {'ForeName': 'Thaddeus J', 'Initials': 'TJ', 'LastName': 'Edens', 'Affiliation': ""Devil's Staircase Consulting, West Vancouver, BC, Canada.""}, {'ForeName': 'Chipo', 'Initials': 'C', 'LastName': 'Berejena', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mutsawashe', 'Initials': 'M', 'LastName': 'Bwakura-Dangarembizi', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Shonhai', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Kusum J', 'Initials': 'KJ', 'LastName': 'Nathoo', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Glass', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver BC, Canada.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, U.K.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, U.K.'}, {'ForeName': 'Amee R', 'Initials': 'AR', 'LastName': 'Manges', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver BC, Canada.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002489']
2694,32852366,Are Some Randomized Clinical Trials Impossible?,"Congenital tibial pseudarthrosis is a rare condition seen in neurofibromatosis type 1 (NF1), and treatment is complex. A randomized, placebo-controlled trial of bone morphogenetic protein (rhBMP-2; INFUSE bone graft) at time of tibial surgery was developed by the Neurofibromatosis Clinical Trials Consortium. Patients were randomized to receive rhBMP-2 that would, or would not, be added to the standard surgical procedure consisting of resection of pseudarthrosis tissue, insertion of a rigid intramedullary rod, and placement of autogenous iliac crest bone graft. Despite involvement of 16 centers with wide experience with NF1 orthopaedic management, only 5 patients (of 54 required) were able to be enrolled in the study during a 3-year time period. Because of the inability to recruit sufficient patients, this study was closed in June 2019, with plans to terminate. The obstacles that were encountered during the study are summarized. The authors question whether a randomized, placebo-controlled trial of a rare pediatric orthopaedic condition is possible to accomplish. Recommendations are provided to guide future studies of orthopaedic manifestations of NF1.Level of Evidence: Level V.",2020,"Despite involvement of 16 centers with wide experience with NF1 orthopaedic management, only 5 patients (of 54 required) were able to be enrolled in the study during a 3-year time period.","['16 centers with wide experience with NF1 orthopaedic management, only 5 patients (of 54 required) were able to be enrolled in the study during a 3-year time period']","['placebo', 'bone morphogenetic protein (rhBMP-2; INFUSE bone graft', 'rhBMP-2 that would, or would not, be added to the standard surgical procedure consisting of resection of pseudarthrosis tissue, insertion of a rigid intramedullary rod, and placement of autogenous iliac crest bone graft']",[],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0053932', 'cui_str': 'Bone morphogenetic proteins'}, {'cui': 'C1445578', 'cui_str': 'dibotermin alfa'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033785', 'cui_str': 'Pseudoarthrosis'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]",[],,0.277798,"Despite involvement of 16 centers with wide experience with NF1 orthopaedic management, only 5 patients (of 54 required) were able to be enrolled in the study during a 3-year time period.","[{'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Rios', 'Affiliation': 'Center for Pediatric Bone Biology and Translational Research, Scottish Rite for Children.'}, {'ForeName': 'B Stephens', 'Initials': 'BS', 'LastName': 'Richards', 'Affiliation': 'Orthopaedic Surgery, UT Southwestern Medical Center.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stevenson', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Oberlander', 'Affiliation': 'Neurofibromatosis Network, Wheaton, IL.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Viskochil', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Gross', 'Affiliation': 'Pediatric Oncology Branch, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dombi', 'Affiliation': 'Pediatric Oncology Branch, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Brigitte C', 'Initials': 'BC', 'LastName': 'Widemann', 'Affiliation': 'Pediatric Oncology Branch, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Plotkin', 'Affiliation': 'Department of Neurology and Cancer Center, Massachusetts General Hospital.'}, {'ForeName': 'Collin J', 'Initials': 'CJ', 'LastName': 'May', 'Affiliation': 'Departments of Orthopaedics.'}, {'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Ullrich', 'Affiliation': ""Neurology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Rachel Y', 'Initials': 'RY', 'LastName': 'Goldstein', 'Affiliation': ""Department of Orthopaedics, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Viral', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Divisions of Orthopaedics.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Schorry', 'Affiliation': ""Human Genetics, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001650']
2695,32854599,Promoting Adapted Physical Activity Regardless of Language Ability in Young Children With Autism Spectrum Disorder.,"Purpose : There is a relationship between motor and language skills in children with Autism Spectrum Disorder (ASD), but little work addresses the ramifications of this relationship for professionals who teach motor skills to this population. Within a motor skills intervention, this study probed the importance of language skills for motor intervention. We examined the relationship between motor and language skills at baseline, and then the relationship between baseline language skills and motor improvements resulting from the intervention.  Method : Twenty children aged 4-6 years with ASD participated. Eleven children received 20 hr per week of motor intervention for 8 weeks. Nine children did not receive motor intervention. Language skills (Mullen Scales of Early Learning) and motor skills (Test of Gross Motor Development - 2) were assessed at baseline and post-intervention. Spearman correlations tested the associations between baseline language and baseline motor skills. This analysis was repeated in the intervention sample to test the association between baseline language level and response to intervention (motor skill changes from baseline to post-intervention).  Results : Prior to intervention, locomotor skills are positively correlated (p < .001) with both receptive (rs = 0.827) and expressive (rs = 0.722) language skills. Similarly, object-control skills are positively correlated (rs < .001) with receptive (rs = 0.779) and expressive (rs = 0.729) language skills. However, those baseline language skills do not relate to motor change in the experimental group.  Conclusion : These results suggest that motor programs may improve motor skills in children with ASD when language is supported, regardless of pre-program language ability.",2020,"Prior to intervention, locomotor skills are positively correlated (p < .001) with both receptive (rs = 0.827) and expressive (rs = 0.722) language skills.","['Young Children With Autism Spectrum Disorder', 'children with Autism Spectrum Disorder (ASD', 'children with ASD', 'Twenty children aged 4-6 years with ASD participated']",[],"['motor skills', 'Language skills (Mullen Scales of Early Learning) and motor skills (Test of Gross Motor Development - 2', 'Physical Activity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",20.0,0.115655,"Prior to intervention, locomotor skills are positively correlated (p < .001) with both receptive (rs = 0.827) and expressive (rs = 0.722) language skills.","[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Ketcheson', 'Affiliation': 'Wayne State University.'}, {'ForeName': 'Isabella Theresa', 'Initials': 'IT', 'LastName': 'Felzer-Kim', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Hauck', 'Affiliation': 'Michigan State University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1788205']
2696,32854601,Positive Impacts of a Sport Intervention on Male Students of Color and School Climate.,"A positive school climate is strongly associated with enhanced student outcomes. With the disengagement of Black and Latinx youth living in poverty being at an all-time high, participation in sport-based youth development (SBYD) programs may enhance school climate, while capitalizing on existing interests.  Purpose:  The purpose of this study was to examine the impact of a SBYD intervention on male students of color and school climate.  Method:  Using a mixed-methods quasi-experimental design, 32 male students of color (11 Black, 13 Latinx, 8 two or more races) participated in an SBYD intervention, twice a week for a total of 20 weeks (Ages 10-14,  M  = 11.46). School climate data were gathered at the beginning and the end of the school year. Student, teacher, and administrator focus groups and interviews were also conducted at the end of the year.  Results:  A statistically significant interaction was found between students who participated in the intervention and those who did not participate in the intervention, on school climate measures  F (1,74) = 15.00,  p  < .01, partial η 2  = .17. Overall school climate scores were statistically significantly greater in the intervention group ( F (1,74) = 19.22,  p  < .01, partial η 2  = .20) at the end of the year. Focus group data also revealed themes of improved school connectedness, peer support, the acquisition of social/civic skills, and school engagement.  Conclusions:  A SBYD intervention may be a viable strategy to engage disconnected students and increase school climate perceptions, particularly among male students of color living in poverty.",2020,"Overall school climate scores were statistically significantly greater in the intervention group ( F (1,74) = 19.22,  ","['male students of color and school climate', 'Male Students of Color and School Climate', '32 male students of color (11 Black, 13 Latinx, 8 two or more races) participated in an', 'male students of color living in poverty']","['SBYD intervention', 'Sport Intervention']","['Overall school climate scores', 'school connectedness, peer support, the acquisition of social/civic skills, and school engagement']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",32.0,0.0129953,"Overall school climate scores were statistically significantly greater in the intervention group ( F (1,74) = 19.22,  ","[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Mala', 'Affiliation': 'University of Connecticut.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Corral', 'Affiliation': 'University of Connecticut.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'McGarry', 'Affiliation': 'University of Connecticut.'}, {'ForeName': 'Charles D T', 'Initials': 'CDT', 'LastName': 'Macauley', 'Affiliation': 'University of Connecticut.'}, {'ForeName': 'Nneka A', 'Initials': 'NA', 'LastName': 'Arinze', 'Affiliation': 'University of Connecticut.'}, {'ForeName': 'Kolin', 'Initials': 'K', 'LastName': 'Ebron', 'Affiliation': 'University of Connecticut.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1789039']
2697,32854610,Low-grade chronic inflammation is attenuated by exercise training in obese adults through down-regulation of ASC gene in peripheral blood: a pilot study.,"BACKGROUND


Obesity is characterized by low-grade chronic inflammation and an excess of adipose tissue. The ASC gene encodes a protein that is part of the NLRP3 inflammasome, a cytosolic multiprotein complex that is associated with inflammation and metabolic alterations. To our knowledge, there is no evidence regarding ASC gene activity in obese adults in response to lifestyle modifications.
PURPOSE


To evaluate the effect of hypocaloric diet and moderate-intensity structured exercise intervention on ASC gene expression and inflammatory markers in obese adults.
METHODS


Thirty-seven obese individuals aged 25 to 50 years were randomized to the hypocaloric diet exercise group or hypocaloric diet group. The participants underwent a 4-month follow-up. Electrical bioimpedance was used for body composition analysis. Biochemical data were analyzed by dry chemistry and insulin levels by ELISA. ASC gene expression from peripheral blood was performed using real-time PCR. Dietary data was collected through questionnaires and analyzed using the Nutritionist Pro™ software. Quantification of cytokines was conducted using Bio-Plex Pro™ Human cytokine. The Astrand-Ryhming test was used to estimate the maximum oxygen volume and design the moderate-intensity structured exercise program ~ 75% heart rate (HR) RESULTS: After the intervention, both study groups significantly improved body composition (decreased weight, fat mass, waist circumference and abdominal obesity, p < 0.05). Besides, the diet-exercise group significantly decreased ASC mRNA expression, MCP-1, and MIP-1β inflammatory cytokines compared to the diet group (p < 0.05). While in the diet group, MCP-1 and IL-8 exhibited significantly decreased levels (p < 0.05). In the diet-exercise group, a positive correlation between the atherogenic index and waist circumference was found (r = 0.822, p = 0.011), and a negative correlation was observed between the delta of ASC mRNA expression and IL-10 levels at the end of the intervention (r = - 0.627, p = 0.019).
CONCLUSION


Low-grade chronic inflammation was attenuated through individualized exercise prescription and our findings highlight the role of the ASC gene in the inflammation of obese adults.
TRIAL REGISTRATION


ClinicalTrials.gov , number NCT04315376 . Registered 20 March 2020-retrospectively registered.",2020,"Besides, the diet-exercise group significantly decreased ASC mRNA expression, MCP-1, and MIP-1β inflammatory cytokines compared to the diet group (p < 0.05).","['Thirty-seven obese individuals aged 25 to 50\u2009years', 'obese adults']","['moderate-intensity structured exercise program ', 'Electrical bioimpedance', 'hypocaloric diet and moderate-intensity structured exercise intervention', 'exercise training', 'hypocaloric diet exercise group or hypocaloric diet group']","['ASC gene expression and inflammatory markers', 'ASC mRNA expression, MCP-1, and MIP-1β inflammatory cytokines', 'atherogenic index and waist circumference', 'body composition (decreased weight, fat mass, waist circumference and abdominal obesity', 'delta of ASC mRNA expression and IL-10 levels', 'Low-grade chronic inflammation']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3710940', 'cui_str': 'STS protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}]",37.0,0.0512333,"Besides, the diet-exercise group significantly decreased ASC mRNA expression, MCP-1, and MIP-1β inflammatory cytokines compared to the diet group (p < 0.05).","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Barrón-Cabrera', 'Affiliation': 'Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara, Sierra Mojada 950, zip code, 44340, Guadalajara, Jalisco, México.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'González-Becerra', 'Affiliation': 'Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara, Sierra Mojada 950, zip code, 44340, Guadalajara, Jalisco, México.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rosales-Chávez', 'Affiliation': 'Respiratory Therapy Unit, Health Sciences University Center, University of Guadalajara, Sierra Mojada 950, zip code, 44340, Guadalajara, Jalisco, México.'}, {'ForeName': 'Alondra', 'Initials': 'A', 'LastName': 'Mora-Jiménez', 'Affiliation': 'Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara, Sierra Mojada 950, zip code, 44340, Guadalajara, Jalisco, México.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Hernández-Cañaveral', 'Affiliation': 'Microbiology and Pathology Department, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara, Sierra Mojada 950, zip code, 44340, Guadalajara, Jalisco, México.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Martínez-López', 'Affiliation': 'Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara, Sierra Mojada 950, zip code, 44340, Guadalajara, Jalisco, México. erikamtz27@yahoo.com.mx.'}]",Genes & nutrition,['10.1186/s12263-020-00674-0']
2698,32854613,Effects of Desflurane and Sevoflurane anesthesia on regulatory T cells in patients undergoing living donor kidney transplantation: a randomized intervention trial.,"BACKGROUND


Volatile anesthetic agents used during surgery have immunomodulatory effects which could affect postoperative outcomes. Recognizing that regulatory T cells (Tregs) plays crucial roles in transplant tolerance and high peripheral blood Tregs associated with stable kidney graft function, knowing which volatile anesthetic agents can induce peripheral blood Tregs increment would have clinical implications. This study aimed to compare effects of desflurane and sevoflurane anesthesia on peripheral blood Tregs induction in patients undergoing living donor kidney transplantation.
METHODS


A prospective, randomized, double-blind trial in living donor kidney transplant recipients was conducted at a single center, tertiary-care, academic university hospital in Thailand during August 2015 - June 2017. Sixty-six patients were assessed for eligibility and 40 patients who fulfilled the study requirement were equally randomized and allocated to desflurane versus sevoflurane anesthesia during transplant surgery. The primary outcome included absolute changes of peripheral blood CD4 + CD25 + FoxP3 + Tregs which measured by flow cytometry and expressed as the percentage of the total population of CD4 +  T lymphocytes at pre-exposure (0-h) and post-exposure (2-h and 24-h) to anesthetic gas. P-value < 0.05 denoted statistical significance.
RESULTS


Demographic data were comparable between groups. No statistical difference of peripheral blood Tregs between desflurane and sevoflurane groups observed at the baseline pre-exposure (3.6 ± 0.4% vs. 3.1 ± 0.4%; p = 0.371) and 2-h post-exposure (3.0 ± 0.3% vs. 3.5 ± 0.4%; p = 0.319). At 24-h post-exposure, peripheral blood Tregs was significantly higher in desflurane group (5.8 ± 0.5% vs. 4.1 ± 0.3%; p = 0.008). Within group analysis showed patients receiving desflurane, but not sevoflurane, had 2.7% increase in peripheral blood Treg over 24-h period (p < 0.001).
CONCLUSION


This study provides the clinical trial-based evidence that desflurane induced peripheral blood Tregs increment after 24-h exposure, which could be beneficial in the context of kidney transplantation. Mechanisms of action and clinical advantages of desflurane anesthesia based on Treg immunomodulation should be investigated in the future.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02559297 . Registered 22 September 2015 - retrospectively registered.",2020,No statistical difference of peripheral blood Tregs between desflurane and sevoflurane groups observed at the baseline pre-exposure (3.6 ± 0.4% vs. 3.1 ± 0.4%; p = 0.371) and 2-h post-exposure (3.0 ± 0.3% vs. 3.5 ± 0.4%; p = 0.319).,"['patients undergoing living donor kidney transplantation', 'Registered 22 September 2015 - retrospectively registered', 'living donor kidney transplant recipients was conducted at a single center, tertiary-care, academic university hospital in Thailand during August 2015 - June 2017', 'Sixty-six patients were assessed for eligibility and 40 patients who fulfilled the study requirement']","['sevoflurane anesthesia', 'Desflurane and Sevoflurane anesthesia', 'desflurane and sevoflurane anesthesia', 'desflurane anesthesia', 'desflurane', 'sevoflurane']","['absolute changes of peripheral blood CD4 + CD25 + FoxP3 + Tregs which measured by flow cytometry and expressed as the percentage of the total population of CD4 +  T lymphocytes at pre-exposure (0-h) and post-exposure (2-h and 24-h) to anesthetic gas', 'regulatory T cells', 'peripheral blood Tregs', 'peripheral blood Treg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007507', 'cui_str': 'Lymphocyte antigen CD25'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0242902', 'cui_str': 'Anesthetic Gases'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}]",66.0,0.262017,No statistical difference of peripheral blood Tregs between desflurane and sevoflurane groups observed at the baseline pre-exposure (3.6 ± 0.4% vs. 3.1 ± 0.4%; p = 0.371) and 2-h post-exposure (3.0 ± 0.3% vs. 3.5 ± 0.4%; p = 0.319).,"[{'ForeName': 'Arpa', 'Initials': 'A', 'LastName': 'Chutipongtanate', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Sasichol', 'Initials': 'S', 'LastName': 'Prukviwat', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nutkridta', 'Initials': 'N', 'LastName': 'Pongsakul', 'Affiliation': 'Pediatric Translational Research Unit, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Supanart', 'Initials': 'S', 'LastName': 'Srisala', 'Affiliation': 'Research Center, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nakarin', 'Initials': 'N', 'LastName': 'Kamanee', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nuttapon', 'Initials': 'N', 'LastName': 'Arpornsujaritkun', 'Affiliation': 'Vascular and Transplantation Unit, Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Goragoch', 'Initials': 'G', 'LastName': 'Gesprasert', 'Affiliation': 'Vascular and Transplantation Unit, Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nopporn', 'Initials': 'N', 'LastName': 'Apiwattanakul', 'Affiliation': 'Division of Infectious Disease, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suradej', 'Initials': 'S', 'LastName': 'Hongeng', 'Affiliation': 'Division of Hematology and Oncology, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Wichai', 'Initials': 'W', 'LastName': 'Ittichaikulthol', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Vasant', 'Initials': 'V', 'LastName': 'Sumethkul', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Chutipongtanate', 'Affiliation': 'Pediatric Translational Research Unit, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand. schuti.rama@gmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01130-7']
2699,32854664,First-step validation of a text message-based application for newborn clinical management among pediatricians.,"BACKGROUND


Neonatal mortality is high in developing countries. Lack of adequate training and insufficient management skills for sick newborn care contribute to these deaths. We developed a phone application dubbed Protecting Infants Remotely by Short Message Service (PRISMS). The PRISMS application uses routine clinical assessments with algorithms to provide newborn clinical management suggestions. We measured the feasibility, acceptability and efficacy of PRISMS by comparing its clinical case management suggestions with those of experienced pediatricians as the gold standard.
METHODS


Twelve different newborn case scenarios developed by pediatrics residents, based on real cases they had seen, were managed by pediatricians and PRISMS® .  Each pediatrician was randomly assigned six of twelve cases. Pediatricians developed clinical case management plans for all assigned cases and then obtained PRISMS suggested clinical case managements. We calculated percent agreement and kappa (k) statistics to test the null hypothesis that pediatrician and PRISMS management plans were independent.
RESULTS


We found high level of agreement between pediatricians and PRISMS for components of newborn care including: 10% dextrose (Agreement = 73.8%), normal saline (Agreement = 73.8%), anticonvulsants (Agreement = 100%), blood transfusion (Agreement =81%), phototherapy (Agreement = 90.5%), and supplemental oxygen (agreement = 69.1%). However, we found poor agreement with potential investigations such as complete blood count, blood culture and lumbar puncture. PRISMS had a user satisfaction score of 3.8 out of 5 (range 1 = strongly disagree, 5 = strongly agree) and an average PRISMS user experience score of 4.1 out of 5 (range 1 = very bad, 5 = very good).
CONCLUSION


Management plans for newborn care from PRISMS showed good agreement with management plans from experienced Pediatricians. We acknowledge that the level of agreement was low in some aspects of newborn care.",2020,"PRISMS had a user satisfaction score of 3.8 out of 5 (range 1 = strongly disagree, 5 = strongly agree) and an average PRISMS user experience score of 4.1 out of 5 (range 1 = very bad, 5 = very good).
","['Twelve different newborn case scenarios developed by pediatrics residents, based on real cases they had seen, were managed by pediatricians and PRISMS® ', 'newborn clinical management among pediatricians', 'sick newborn care']",['phone application dubbed Protecting Infants Remotely by Short Message Service (PRISMS'],"['complete blood count, blood culture and lumbar puncture', 'feasibility, acceptability and efficacy', 'blood transfusion']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.0176293,"PRISMS had a user satisfaction score of 3.8 out of 5 (range 1 = strongly disagree, 5 = strongly agree) and an average PRISMS user experience score of 4.1 out of 5 (range 1 = very bad, 5 = very good).
","[{'ForeName': 'Santorino', 'Initials': 'S', 'LastName': 'Data', 'Affiliation': 'Department of Pediatrics and Child Health, Mbarara University of Science and Technology, Mbarara, Uganda. boymukedata@gmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mukama', 'Affiliation': 'Consortium for Affordable Medical Technologies in Uganda, Mbarara, Uganda.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Singhal', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Bajunirwe', 'Affiliation': 'Department of Community Health, Mbarara University of Science and Technology, Mbarara, Uganda.'}]",BMC pediatrics,['10.1186/s12887-020-02307-2']
2700,32852421,"Influence of Topical Anesthesia on Superficial Sensitivity: A Double-Blind, Randomized, Placebo-Controlled Study on 48 Healthy Subjects.","BACKGROUND


Topical anesthetics are used in noninvasive transdermal anesthesia to decrease the superficial pain sensation threshold during dermatologic surgery. Combined pain relief and sensitivity loss can avoid discomfort during the surgery.
OBJECTIVE


The aim of this placebo-controlled study was to compare the efficacy of 3 commonly used topical agents by collating loss of sensitivity over time.
MATERIALS AND METHODS


Three topical anesthetic creams, a topical anti-inflammatory cream, and a moisturizing cream were applied on the left volar forearm of each of the 48 healthy Caucasian participants. Sensitivity was assessed with the dynamic 2-point discrimination and the Semmes-Weinstein test at 0, 60, 90, 120, 150, and 180 minutes after cream application.
RESULTS


After 180 minutes, benzocaine showed a significantly lower 2-point discrimination reduction than lidocaine alone and a lidocaine and prilocaine mixture. Sensory threshold measurements by the Semmes-Weinstein test after 60 minutes revealed a significantly higher effect with lidocaine alone and with the lidocaine and prilocaine mixture than with benzocaine.
CONCLUSION


The authors found a stronger skin sensitivity reduction by the eutectic lidocaine and prilocaine mixture and lidocaine alone compared with benzocaine. We suggest increased discomfort reduction in topical anesthetic supported dermatologic surgery by the eutectic mixture and lidocaine alone.",2020,"Sensory threshold measurements by the Semmes-Weinstein test after 60 minutes revealed a significantly higher effect with lidocaine alone and with the lidocaine and prilocaine mixture than with benzocaine.
","['48 healthy Caucasian participants', '48 Healthy Subjects']","['topical anti-inflammatory cream, and a moisturizing cream', 'lidocaine', 'prilocaine mixture and lidocaine', 'placebo', 'benzocaine', 'Placebo', 'prilocaine', 'Topical Anesthesia']","['superficial pain sensation', 'Sensitivity', 'skin sensitivity reduction', 'Superficial Sensitivity', 'discomfort reduction']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005059', 'cui_str': 'Benzocaine'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0234228', 'cui_str': 'Superficial pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0520898', 'cui_str': 'Skin sensitivity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",48.0,0.201592,"Sensory threshold measurements by the Semmes-Weinstein test after 60 minutes revealed a significantly higher effect with lidocaine alone and with the lidocaine and prilocaine mixture than with benzocaine.
","[{'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Illg', 'Affiliation': '*All authors are affiliated with the Department of Hand, Plastic and Reconstructive Surgery, BG Unfallklinik Tuebingen, Eberhard Karls University Tuebingen, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Krauss', 'Affiliation': ''}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Kersten', 'Affiliation': ''}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Daigeler', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'All authors are affiliated with the Department of Hand, Plastic and Reconstructive Surgery, BG Unfallklinik Tuebingen, Eberhard Karls University Tuebingen, Germany.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002608']
2701,32852426,"A Randomized, Split-Body, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Poly-L-lactic Acid for the Treatment of Upper Knee Skin Laxity.","BACKGROUND


Skin laxity of the upper knee and lower thigh is a common complaint among patients.
OBJECTIVE


This is a randomized, double-blinded, split-body, placebo-controlled study to evaluate the safety and efficacy of poly-L-lactic acid (PLLA) for treatment of upper knee skin laxity.
MATERIALS AND METHODS


Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled. The patients were randomized to receive 3 treatments of PLLA in 1 knee, whereas the other knee received 3 treatments of bacteriostatic water.
RESULTS


Statistically significant improvement as rated on the physician global aesthetic improvement scale was seen at Day 56 after final treatment in the active knee when compared with the placebo knee. This improvement was sustained at Day 84 and Day 168 after final treatment visits. No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale.
CONCLUSION


Based on our study, PLLA may be a safe and effective modality in addressing upper knee skin laxity. Larger studies with longer follow-up times and a validated knee laxity scale are needed to further determine if and how much improvement can be achieved.",2020,"No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale.
","['patients', 'Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled', 'Upper Knee Skin Laxity', 'upper knee skin laxity']","['Poly-L-lactic Acid', 'PLLA', 'placebo', 'poly-L-lactic acid (PLLA', 'bacteriostatic water', 'Placebo']","['physician global aesthetic improvement scale', 'subject global aesthetic score or the subject satisfaction scale', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0222275', 'cui_str': 'Skin structure of knee'}]","[{'cui': 'C0525166', 'cui_str': 'Poly-L-lactic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.0421039,"No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale.
","[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Kollipara', 'Affiliation': 'Westlake Dermatology & Cosmetic Surgery, Dallas, Texas.'}, {'ForeName': 'Elika', 'Initials': 'E', 'LastName': 'Hoss', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Boen', 'Affiliation': 'Cosmetic Laser Dermatology, San Diego, California.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Alhaddad', 'Affiliation': 'Slocum-Dickinson Medical Group, New Hartford, New York.'}, {'ForeName': 'Sabrina G', 'Initials': 'SG', 'LastName': 'Fabi', 'Affiliation': 'Cosmetic Laser Dermatology, San Diego, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002685']
2702,32852428,"Effectiveness of a 595-nm Pulsed Dye Laser for the Treatment of Basal Cell Carcinoma Using One Double-Stacked Pulse Session: A Randomized, Double-Blinded Controlled Trial.","BACKGROUND


Surgical and nonsurgical methods are used for treating basal cell carcinoma (BCC). Few randomized controlled trials exist on the effectiveness of the pulsed dye laser (PDL) on BCC treatment.
OBJECTIVE


We investigated the effectiveness of PDL treatment in a single session for the management of nodular and superficial BCCs on the trunk and extremities of adults using a randomized, double-blind, controlled technique.
METHODS


We used settings of fluence 7.5 J/cm, 3-ms pulse duration, no dynamic cooling, 10-mm spot size, 10% overlap between pulses, and 2 stacked pulses on a 595-nm wavelength laser. Histopathologic clearance on excision of tumor with 4-mm margins was the primary outcome measure.
RESULTS


Twenty-four patients were included in the study, with 14 in the laser treatment group and 10 patients in the sham/control group. In total, 10/14 (71.4%) of the tumors in the treatment group were successfully treated with no residual tumor on excisional specimen histology, compared with 3/10 (30.0%) of the control group (p = .045).
CONCLUSION


Our study shows that PDL may be an effective treatment for low-risk BCCs of the trunk and extremities, but the cure rate is lower than those of other treatments for BCC. Thus, PDL under the current settings cannot be recommended.",2020,"In total, 10/14 (71.4%) of the tumors in the treatment group were successfully treated with no residual tumor on excisional specimen histology, compared with 3/10 (30.0%) of the control group (p = .045).
","['Twenty-four patients were included in the study, with 14 in the laser treatment group and 10 patients in the sham/control group']","['595-nm Pulsed Dye Laser', 'pulsed dye laser (PDL', 'PDL']","['cure rate', 'Histopathologic clearance', 'excisional specimen histology']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C5191367', 'cui_str': '595'}, {'cui': 'C0392258', 'cui_str': 'Dye laser device'}, {'cui': 'C1289859', 'cui_str': 'Pulsed dye laser device'}]","[{'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0019638', 'cui_str': 'Histology'}]",24.0,0.302009,"In total, 10/14 (71.4%) of the tumors in the treatment group were successfully treated with no residual tumor on excisional specimen histology, compared with 3/10 (30.0%) of the control group (p = .045).
","[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Chow', 'Affiliation': 'Department of Dermatology, University of California, San Diego, California.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Medicine, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Michael Shane', 'Initials': 'MS', 'LastName': 'Hamman', 'Affiliation': 'Department of Dermatology, University of California, San Diego, California.'}, {'ForeName': 'Shang I Brian', 'Initials': 'SIB', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology, University of California, San Diego, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002689']
2703,32852435,Men Report Higher Levels of Acute Pain Than Women: A Casual Finding in a Randomized Controlled Trial.,,2020,,['Than Women'],[],['Acute Pain'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0184567', 'cui_str': 'Acute pain'}]",,0.341122,,"[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Salmerón-González', 'Affiliation': 'Plastic Surgeons, Department of Plastic Surgery and Microsurgery, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'García-Vilariño', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sánchez-García', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pérez-García', 'Affiliation': ''}]",Plastic surgical nursing : official journal of the American Society of Plastic and Reconstructive Surgical Nurses,['10.1097/PSN.0000000000000310']
2704,32852460,"Blood pressure and cardiovascular risk factors in women treated for climacteric symptoms with acupuncture, phytoestrogens, or hormones.","OBJECTIVE


To evaluate the response of cardiovascular risk factors to the treatment of climacteric symptoms.
METHODS


In this prospective study, women reporting climacteric symptoms were randomized to 3 months of treatment with either acupuncture (n = 19), phytoestrogens (75 mg soy isoflavones, BID; n = 22), or low-dose hormone therapy (HT; 0.3 mg conjugated equine oestrogens plus 1.5 mg medroxyprogesterone acetate; n = 20). Greene's climacteric scale, blood pressure (BP), lipids, glucose, insulin, and homeostatic model assessment of insulin resistance were assessed before and after treatment. Observed changes were compared by analysis of variance.
RESULTS


HT and acupuncture reduced Greene climacteric score to a similar extent, but the effect of phytoestrogens was significantly lower (P < 0.05). With acupuncture, systolic (-7.4 ± 15.3 mm Hg; P < 0.05) and diastolic BP (-8.3 ± 7.7mm Hg; P < 0.01) decreased, and the same occurred with phytoestrogens (-8.4 ± 9.0 mm Hg [P < 0.01] and -6.6 ± 7.9 mm Hg [P < 0.01]). Neither BP systolic (1.9 ± 17.5 mm Hg) nor BP diastolic (-1.4 ± 9.6 mm Hg) changed during HT. Low-density lipoprotein cholesterol decreased with phytoestrogens (-9.9 ± 19.6 mg/dL; P < 0.05), and triglycerides increased with both HT (34.5 ± 12.2 mg/dL; P < 0.01) and phytoestrogens (17.41 ± 24.4 mg/dL; P < 0.01). A slight but significant increase in homeostatic model assessment of insulin resistance (0.14 ± 0.5; P < 0.05) was observed after HT.
CONCLUSIONS


Treatment of climacteric symptoms with acupuncture and phytoestrogens, but not HT, is associated with a clear BP reduction, and phytoestrogens with potentially positive alterations in low-density lipoprotein cholesterol level.
TRIAL REGISTRATION


EudractCT Number 2008-006053-41. : Video Summary:http://links.lww.com/MENO/A637.",2020,"A slight but significant increase in homeostatic model assessment of insulin resistance (0.14 ± 0.5; P < 0.05) was observed after HT.
","['women treated for climacteric symptoms with acupuncture, phytoestrogens, or hormones', 'women reporting climacteric symptoms']","['acupuncture and phytoestrogens', 'Video Summary:http://links.lww.com/MENO/A637', 'conjugated equine oestrogens plus 1.5\u200amg medroxyprogesterone acetate', 'acupuncture', 'phytoestrogens (75\u200amg soy isoflavones, BID; n\u200a=\u200a22), or low-dose hormone therapy (HT']","['Greene climacteric score', 'BP diastolic', 'homeostatic model assessment of insulin resistance', 'Low-density lipoprotein cholesterol', 'Blood pressure and cardiovascular risk factors', 'BP systolic', 'triglycerides', ""Greene's climacteric scale, blood pressure (BP), lipids, glucose, insulin, and homeostatic model assessment of insulin resistance"", 'diastolic BP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1306878', 'cui_str': 'Climacteric discomfort'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0071011', 'cui_str': 'Phytoestrogen'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0071011', 'cui_str': 'Phytoestrogen'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1306620', 'cui_str': 'Blood pressure systolic'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.167643,"A slight but significant increase in homeostatic model assessment of insulin resistance (0.14 ± 0.5; P < 0.05) was observed after HT.
","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Palma', 'Affiliation': 'Obstetrics and Gynecology Clinic, Azienda Ospedaliero Universitaria di Modena, Modena.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fontanesi', 'Affiliation': 'Obstetrics and Gynecology Unit, Nuovo Ospedale Civile di Sassuolo, Sassuolo.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Neri', 'Affiliation': 'Obstetrics and Gynecology Clinic, Azienda Ospedaliero Universitaria di Modena, Modena.'}, {'ForeName': 'Anjeza', 'Initials': 'A', 'LastName': 'Xholli', 'Affiliation': 'Ginecologia e Ostetricia, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili, Università degli Studi di Genova, Ospedale Policlinico San Martino-IRCCS, Largo Benzi 3, Genova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Obstetrics and Gynecology Clinic, Azienda Ospedaliero Universitaria di Modena, Modena.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Cagnacci', 'Affiliation': 'Ginecologia e Ostetricia, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili, Università degli Studi di Genova, Ospedale Policlinico San Martino-IRCCS, Largo Benzi 3, Genova, Italy.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001626']
2705,32852475,"""Reply: Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.""",,2020,,[],['DIEP Flap and Fluorescent Angiography'],[],[],"[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0086305', 'cui_str': 'Angiography, Fluorescence'}]",[],,0.215261,,"[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Varela', 'Affiliation': '. Ramon Varela, MD. Department of Plastic Surgery, Hospital Quiron Madrid-Pozuelo, Madrid (Spain).'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Landin', 'Affiliation': '. Luis Landin, MD, PhD. Fundación FIBHULP-IdiPaz, Hospital Universitario La Paz, Madrid (Spain).'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007298']
2706,32852479,"Comments on ""Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial"".",,2020,,[],['DIEP Flap and Fluorescent Angiography'],[],[],"[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0086305', 'cui_str': 'Angiography, Fluorescence'}]",[],,0.188824,,"[{'ForeName': 'Ziying', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007297']
2707,32852530,Efficacy and Safety of 2 Fingolimod Doses vs Glatiramer Acetate for the Treatment of Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial.,"Importance


Doses of fingolimod lower than 0.5 mg per day were not investigated during the fingolimod clinical development program. Whether lower doses of fingolimod might retain efficacy with fewer safety risks remains unknown.
Objective


To evaluate the efficacy and safety of fingolimod, 0.5 mg, and fingolimod, 0.25 mg, compared with glatiramer acetate and to assess whether these doses of fingolimod show superior efficacy to glatiramer acetate in adult patients with relapsing-remitting multiple sclerosis.
Interventions


Fingolimod, 0.5 mg, or fingolimod, 0.25 mg, orally once per day or glatiramer acetate, 20 mg, subcutaneously once per day.
Design, Setting, and Participants


The Multiple Sclerosis Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone (ASSESS) was a phase 3b multicenter randomized rater-blinded and dose-blinded 12-month clinical trial conducted between August 9, 2012, and April 30, 2018 (including the time required to recruit participants). A total of 1461 patients aged 18 to 65 years with relapsing-remitting multiple sclerosis were screened, and 1064 participants were randomized. These participants had at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years and an Expanded Disability Status Scale score of 0 to 6 at screening. Data were analyzed between September and November 2018.
Main Outcomes and Measures


The superiority of the fingolimod doses was tested hierarchically, with fingolimod, 0.5 mg, vs glatiramer acetate, 20 mg, tested first, followed by fingolimod, 0.25 mg, vs glatiramer acetate, 20 mg. The primary end point was the reduction in annualized relapse rate (ARR). Magnetic resonance imaging parameters, safety, and tolerability were also assessed.
Results


Of 1461 adult patients screened, 1064 participants (72.8%) were randomized (mean [SD] age, 39.6 [11.0] years; 792 women [74.4%]) to 3 treatment groups: 352 participants received fingolimod, 0.5 mg, 370 participants received fingolimod, 0.25 mg, and 342 participants received glatiramer acetate, 20 mg. In total, 859 participants (80.7%) completed the study. Treatment with fingolimod, 0.5 mg, was superior to treatment with glatiramer acetate, 20 mg, in reducing ARR (40.7% relative reduction); the relative reduction with fingolimod, 0.25 mg, was 14.6%, which was not statistically significant (for fingolimod, 0.5 mg, ARR, 0.15; 95% CI, 0.11-0.21; for fingolimod, 0.25 mg, ARR, 0.22; 95% CI, 0.17-0.29; for glatiramer acetate, 20 mg, ARR, 0.26; 95% CI, 0.20-0.34). Treatment with both fingolimod doses (0.5 mg and 0.25 mg) significantly reduced new or newly enlarging T2 and gadolinium-enhancing T1 lesions compared with treatment with glatiramer acetate. Adverse events were reported in similar proportions across treatment groups (312 participants [90.4%] in the fingolimod, 0.5 mg, group, 323 participants [88.3%] in the fingolimod, 0.25 mg, group, and 283 participants [87.3%] in the glatiramer acetate group).
Conclusions and Relevance


Fingolimod, 0.5 mg, demonstrated superior clinical efficacy compared with glatiramer acetate, 20 mg, and had a superior benefit-risk profile compared with fingolimod, 0.25 mg, in adult participants with relapsing-remitting multiple sclerosis.
Trial Registration


ClinicalTrials.gov Identifier: NCT01633112.",2020,"Adverse events were reported in similar proportions across treatment groups (312 participants [90.4%] in the fingolimod, 0.5 mg, group, 323 participants [88.3%] in the fingolimod, 0.25 mg, group, and 283 participants [87.3%] in the glatiramer acetate group).
","['adult participants with relapsing-remitting multiple sclerosis', 'adult patients with relapsing-remitting multiple sclerosis', '1461 adult patients screened, 1064 participants (72.8%) were randomized (mean [SD] age, 39.6 [11.0] years; 792 women [74.4%]) to 3 treatment groups: 352 participants received fingolimod, 0.5 mg, 370 participants received fingolimod, 0.25 mg, and 342 participants received', '1461 patients aged 18 to 65 years with relapsing-remitting multiple sclerosis were screened, and 1064 participants were randomized', 'Patients With Relapsing-Remitting Multiple Sclerosis', 'August 9, 2012, and April 30, 2018 (including the time required to recruit participants', '859 participants (80.7%) completed the study']","['glatiramer acetate', '2 Fingolimod Doses vs Glatiramer Acetate', 'Fingolimod, 0.5 mg, or fingolimod, 0.25 mg, orally once per day or glatiramer acetate', 'Fingolimod Versus Copaxone (ASSESS', 'fingolimod']","['efficacy and safety', 'reduced new or newly enlarging T2 and gadolinium-enhancing T1 lesions', 'Adverse events', 'Magnetic resonance imaging parameters, safety, and tolerability', 'Efficacy and Safety', 'annualized relapse rate (ARR', 'Expanded Disability Status Scale score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0528175', 'cui_str': 'Copaxone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1461.0,0.0452431,"Adverse events were reported in similar proportions across treatment groups (312 participants [90.4%] in the fingolimod, 0.5 mg, group, 323 participants [88.3%] in the fingolimod, 0.25 mg, group, and 283 participants [87.3%] in the glatiramer acetate group).
","[{'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Myla D', 'Initials': 'MD', 'LastName': 'Goldman', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Corboy', 'Affiliation': 'Rocky Mountain Multiple Sclerosis Center, University of Colorado, Aurora.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Singer', 'Affiliation': 'The Multiple Sclerosis Center for Innovations in Care, Missouri Baptist Medical Center, St Louis.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Ford', 'Affiliation': 'University of New Mexico, Albuquerque.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Weinstock-Guttman', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Perelman School of Medicine, Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Mientus', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sienkiewicz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Karan', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.2950']
2708,32852531,Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Untreated Oral Cavity Squamous Cell Carcinoma: A Phase 2 Open-Label Randomized Clinical Trial.,"Importance


Novel approaches are needed to improve outcomes in patients with squamous cell carcinoma of the oral cavity. Neoadjuvant immunotherapy given prior to surgery and combining programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immune checkpoint inhibitors are 2 strategies to enhance antitumor immune responses that could be of benefit.
Design, Setting, and Participants


In this randomized phase 2 clinical trial conducted at 1 academic center, 29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019.
Interventions


Treatment was administered with nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab, 1 mg/kg, given week 1 only). Patients had surgery 3 to 7 days following cycle 2.
Main Outcomes and Measures


Safety and volumetric response determined using bidirectional measurements. Secondary end points included pathologic and objective response, progression-free survival (PFS), and overall survival. Multiplex immunofluorescence was used to evaluate primary tumor immune markers.
Results


Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38%]). The most common subsite was oral tongue (n = 16). Baseline clinical staging included patients with T2 (n = 20) or greater (n = 9) T stage and 17 patients (59%) with node-positive disease. Median time from cycle 1 to surgery was 19 days (range, 7-21 days); there were no surgical delays. There were toxic effects at least possibly related to study treatment in 21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients. One patient died of conditions thought unrelated to study treatment (postoperative flap failure, stroke). There was evidence of response in both the N and N+I arms (volumetric response 50%, 53%; pathologic downstaging 53%, 69%; RECIST response 13%, 38%; and pathologic response 54%, 73%, respectively). Four patients had major/complete pathologic response greater than 90% (N, n = 1; N+I, n = 3). With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
Conclusions and Relevance


Treatment with N and N+I was feasible prior to surgical resection. We observed promising rates of response in both arms, supporting further neoadjuvant studies with these agents.
Trial Registration


ClinicalTrials.gov Identifier: NCT02919683.",2020,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","['patients with T2 (n\u2009=\u200920) or greater (n\u2009=\u20099) T stage and 17 patients (59%) with node-positive disease', 'Untreated Oral Cavity Squamous Cell Carcinoma', '29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019', 'patients with squamous cell carcinoma of the oral cavity', 'Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38', '21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients']","['Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab', 'Neoadjuvant immunotherapy', 'nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab']","['1-year progression-free survival', 'complete pathologic response', 'overall survival', 'Median time', 'pathologic and objective response, progression-free survival (PFS), and overall survival', 'Measures\n\n\nSafety and volumetric response determined using bidirectional measurements', 'toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",14.0,0.271878,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Schoenfeld', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vickie Y', 'Initials': 'VY', 'LastName': 'Jo', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Rawal', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Catalano', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lako', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Ciantra', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Weirather', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Criscitiello', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Luoma', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Chau', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Lorch', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Kass', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Annino', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goguen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Beth-Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Ross', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Hina J', 'Initials': 'HJ', 'LastName': 'Shah', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Danielle N', 'Initials': 'DN', 'LastName': 'Margalit', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Roy B', 'Initials': 'RB', 'LastName': 'Tishler', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kai W', 'Initials': 'KW', 'LastName': 'Wucherpfennig', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Rodig', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Uppaluri', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA oncology,['10.1001/jamaoncol.2020.2955']
2709,32852548,Artificial pancreas with carbohydrate suggestion performance for unannounced and announced exercise in Type 1 Diabetes.,"OBJECTIVE


To evaluate the safety and performance of a new multivariable closed-loop glucose controller with automatic carbohydrate recommendation (MCL) during and after unannounced and announced exercise in adults with type 1 diabetes (T1D).
RESEARCH DESIGN AND METHODS


A randomized, three-arm, crossover clinical trial was conducted. Participants completed a heavy aerobic exercise session including three 15-min sets on a cycle-ergometer with 5 minutes rest in-between. In a randomly determined order, we compared MCL control with unannounced (CLNA) and announced (CLA) exercise to open-loop therapy (OL). Adults with T1D, insulin pump users and HbA1c between 6.0-8.5% were eligible. We investigated glucose control during and 3 hours after exercise.
RESULTS


Ten subjects (40.8±7.0 years-old; an HbA1c of 7.3±0.8%) participated. The use of the MCL in both closed-loop arms decreased the time <70 mg/dl of sensor glucose (0.0%,[0.0-16.8] and 0.0%,[0.0-19.2] vs. 16.2%,[0.0-26.0], (%,[Percentile 10-90]) CLNA and CLA vs. OL respectively, p=0.047,p=0.063) and the number of hypoglycemic events when compared to OL (CLNA 4 and CLA 3 vs. OL 8; p=0.218,p=0.250). The use of MCL system increased the proportion of time within 70-180 mg/dl (87.8%,[51.1-100] and 91.9%,[58.7-100] vs. 81.1%,[65.4-87.0], (%,[Percentile 10-90]) CLNA and CLA vs. OL respectively, p=0.227, p=0.039). This was achieved with the administration of similar doses of insulin and less amount of carbohydrates.
CONCLUSIONS


MCL with automatic carbohydrate recommendation performed well and was safe during and after both unannounced and announced exercise maintaining glucose mostly within the target range and reducing the risk of hypoglycemia despite of less amount of carbohydrate intake.",2020,"CLNA and CLA vs. OL respectively, p=0.047,p=0.063) and the number of hypoglycemic events when compared to OL (CLNA 4 and CLA 3 vs. OL 8; p=0.218,p=0.250).","['adults with type 1 diabetes (T1D', 'Ten subjects (40.8±7.0 years-old; an HbA1c of 7.3±0.8%) participated', 'Type 1 Diabetes', 'Adults with T1D, insulin pump users and HbA1c between 6.0-8.5% were eligible']","['new multivariable closed-loop glucose controller with automatic carbohydrate recommendation (MCL', 'MCL control with unannounced (CLNA) and announced (CLA) exercise to open-loop therapy (OL', 'heavy aerobic exercise session']",['number of hypoglycemic events'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0023461', 'cui_str': 'Mast cell leukemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0476722,"CLNA and CLA vs. OL respectively, p=0.047,p=0.063) and the number of hypoglycemic events when compared to OL (CLNA 4 and CLA 3 vs. OL 8; p=0.218,p=0.250).","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Viñals', 'Affiliation': 'Diabetes Unit, Endocrinology and Nutrition Dpt. Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Beneyto', 'Affiliation': 'Institute of Informatics and Applications, University of Girona, Girona, Spain.'}, {'ForeName': 'Juan-Fernando', 'Initials': 'JF', 'LastName': 'Martín-SanJosé', 'Affiliation': 'Instituto Universitario de Automática e Informática Industrial, Universitat Politècnica de València, València, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Furió-Novejarque', 'Affiliation': 'Instituto Universitario de Automática e Informática Industrial, Universitat Politècnica de València, València, Spain.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Bertachi', 'Affiliation': 'Federal University of Technology - Paraná (UTFPR), Guarapuava, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bondia', 'Affiliation': 'Instituto Universitario de Automática e Informática Industrial, Universitat Politècnica de València, València, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vehi', 'Affiliation': 'Institute of Informatics and Applications, University of Girona, Girona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Diabetes Unit, Endocrinology and Nutrition Dpt. Hospital Clínic de Barcelona, Spain.'}, {'ForeName': 'Marga', 'Initials': 'M', 'LastName': 'Giménez', 'Affiliation': 'Diabetes Unit, Endocrinology and Nutrition Dpt. Hospital Clínic de Barcelona, Spain.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa562']
2710,32852553,Effect of a Daily Text Messaging and Directly Supervised Therapy Intervention on Oral Mercaptopurine Adherence in Children With Acute Lymphoblastic Leukemia: A Randomized Clinical Trial.,"Importance


Suboptimal adherence to oral mercaptopurine treatment in children with acute lymphoblastic leukemia (ALL) increases the risk of relapse. A frequently expressed barrier to adherence is forgetfulness, which is often overcome by parental vigilance.
Objective


To determine whether a multicomponent intervention, compared with education alone, will result in a higher proportion of patients with ALL who have mercaptopurine adherence rates 95% or higher, for all study participants and among patients younger than 12 years and vs those aged 12 years and older.
Design, Setting, and Participants


The adherence intervention trial was an investigator-initiated, multi-institutional, parallel-group, unblinded, randomized clinical trial conducted between July 16, 2012, and August 8, 2018, at 59 Children's Oncology Group institutions in the US, enrolling patients with ALL diagnosed through age 21 years and receiving mercaptopurine for maintenance. The date of final follow-up was January 2, 2019. Data analysis was performed from February to October 2019.
Interventions


Patients were randomized 1:1 to education alone or the intervention package, which consisted of education and personalized text message reminders daily to prompt directly supervised therapy. Four weeks of baseline adherence monitoring were followed with a 16-week intervention.
Main Outcomes and Measures


The primary end point was the proportion of patients with adherence rates 95% or higher over the duration of the intervention for all study participants, and for those younger than 12 years vs those aged 12 years and older.
Results


There were 444 evaluable patients (median age, 8.1 years; interquartile range, 5.3-14.3 years), including 230 in the intervention group and 214 in the education group. Three hundred two patients (68.0%) were boys, 180 (40.5%) were non-Hispanic White, 170 (38.3%) were Hispanic, 43 (9.7%) were African American, and 51 (11.5%) were Asian or of mixed race/ethnicity. The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08). Exploratory analyses showed that among patients aged 12 years and older, those in the intervention group had higher mean (SE) adherence rates than those in the education group (93.1% [1.1%] vs 90.0% [1.3%]; difference, 3.1%; 95% CI, 0.1%-6.0%; P = .04). In particular, among patients aged 12 years and older with baseline adherence less than 90%, those in the intervention group had higher mean (SE) adherence rates than those in the education group (83.4% [2.5%] vs 74.6% [3.4%]; difference, 8.8%; 95% CI, 2.2%-15.4%; P = .008). No safety concerns were identified.
Conclusions and Relevance


Although this multicomponent intervention did not result in an increase in the proportion of patients with ALL who had mercaptopurine adherence rates 95% or higher, it did identify a high-risk subpopulation to target for future adherence intervention strategies: adolescents with low baseline adherence.
Trial Registration


ClinicalTrials.gov Identifier: NCT01503632.",2020,"The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08).","['444 evaluable patients (median age, 8.1 years; interquartile range, 5.3-14.3 years), including 230 in the intervention group and 214 in the education group', ""59 Children's Oncology Group institutions in the US, enrolling patients with ALL diagnosed through age 21 years and receiving"", 'non-Hispanic White, 170 (38.3%) were Hispanic, 43 (9.7%) were African American, and 51 (11.5%) were Asian or of mixed race/ethnicity', 'children with acute lymphoblastic leukemia (ALL', 'Children With Acute Lymphoblastic Leukemia', 'Three hundred two patients (68.0%) were boys, 180 (40.5%) were', 'patients with ALL who have mercaptopurine adherence rates 95% or higher, for all study participants and among patients younger than 12 years and vs those aged 12 years and older']","['Daily Text Messaging and Directly Supervised Therapy Intervention', 'education alone or the intervention package, which consisted of education and personalized text message reminders daily to prompt directly supervised therapy', 'multicomponent intervention', 'mercaptopurine']","['proportion of patients with adherence rates', 'Oral Mercaptopurine Adherence', 'higher mean (SE) adherence rates', 'mercaptopurine adherence rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.119137,"The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08).","[{'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hageman', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'F Lennie', 'Initials': 'FL', 'LastName': 'Wong', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'McQuaid', 'Affiliation': 'Department of Psychiatryand Human Behavior, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Duncan', 'Affiliation': 'Department of Psychology,West Virginia University, Morgantown.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Cancer and Blood Disease Institute, Division of Hematology/Oncology, Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Freyer', 'Affiliation': ""Cancer and Blood Disease Institute, Division of Hematology/Oncology, Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'Nkechi', 'Initials': 'N', 'LastName': 'Mba', 'Affiliation': ""Department of Pediatric Hematology/Oncology, Driscoll Children's Hospital, Corpus Christi, Texas.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Aristizabal', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, San Diego.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walterhouse', 'Affiliation': ""Department of Pediatrics, Division of Hematology, Oncology, and Stem Cell Transplantation, Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Lew', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia.""}, {'ForeName': 'Pamela Helen-Heilge', 'Initials': 'PH', 'LastName': 'Kempert', 'Affiliation': ""Department of Hematology/Oncology, Miller Children's and Women's Hospital, Long Beach, California.""}, {'ForeName': 'Thomas Bennett', 'Initials': 'TB', 'LastName': 'Russell', 'Affiliation': 'Wake Forest Baptist Comprehensive Cancer Center, Wake Forest University Health Sciences, Winston-Salem, North Carolina.'}, {'ForeName': 'Rene Y', 'Initials': 'RY', 'LastName': 'McNall-Knapp', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': ""Department of Oncology, Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics, NYU Langone Medical Center, New York, New York.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""Department of Pharmaceutical Sciences, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Landier', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.14205']
2711,32852613,"Effects of emixustat hydrochloride in patients with proliferative diabetic retinopathy: a randomized, placebo-controlled phase 2 study.","PURPOSE


To evaluate the effects of oral emixustat hydrochloride on pro-angiogenic and inflammatory cytokines in the aqueous humor, as well as other ophthalmic parameters, in subjects with proliferative diabetic retinopathy (PDR).
METHODS


Twenty-three patients with PDR, with or without diabetic macular edema (DME), were assigned to emixustat or placebo in daily oral doses ranging from 5 to 40 mg over a step-up titration period, for 84 days. The main outcome measures included levels of IL-1β, IL-6, IL-8, TGFβ-1, and VEGF in the aqueous humor.
RESULTS


Seven of 12 subjects (58%) who were randomized to emixustat and 11 of 12 subjects (92%) who were randomized to placebo completed the study. No statistically significant differences between treatment groups were observed for changes in any of the aqueous humor cytokines tested. However, median VEGF levels were slightly reduced in the emixustat but not the placebo group (- 70.0 pg/mL versus + 42.7 pg/mL, or - 11.8% versus + 6.7%). In a post hoc analysis of all subjects (with or without DME), statistically significant differences between treatment arms in mean changes from baseline in central subfield thickness (CST; emixustat - 11.9 μm, placebo + 36.2 μm; P = 0.076) and total macular volume (TMV; emixustat - 0.13 mm 3 , placebo + 0.23 mm 3 ; P = 0.026) were observed, both favoring emixustat. Emixustat's safety profile was consistent with prior studies (i.e., the adverse events of delayed dark adaptation and visual impairment were more common in subjects treated with emixustat).
CONCLUSION


Although this pilot study did not demonstrate statistically significant differences in changes in aqueous humor cytokine levels between the emixustat and placebo groups, VEGF levels were slightly reduced in the emixustat but not in the placebo group. In addition, statistically significant differences favoring the emixustat group were observed in CST and TMV among all subjects. These data warrant further investigation of emixustat's potential therapeutic effects in diabetic retinopathy.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02753400 (April 2016).",2020,No statistically significant differences between treatment groups were observed for changes in any of the aqueous humor cytokines tested.,"['Seven of 12 subjects (58%) who were randomized to emixustat and 11 of 12 subjects (92%) who were randomized to', 'Twenty-three patients with PDR, with or without diabetic macular edema (DME', 'subjects with proliferative diabetic retinopathy (PDR', 'patients with proliferative diabetic retinopathy']","['emixustat or placebo', 'emixustat hydrochloride', 'placebo', 'oral emixustat hydrochloride']","['central subfield thickness', 'adverse events of delayed dark adaptation and visual impairment', 'median VEGF levels', 'levels of IL-1β, IL-6, IL-8, TGFβ-1, and VEGF in the aqueous humor', 'total macular volume', 'CST and TMV', 'VEGF levels', 'aqueous humor cytokine levels']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3884966', 'cui_str': 'emixustat'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C3884966', 'cui_str': 'emixustat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3495915', 'cui_str': 'Delayed dark adaptation'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0003662', 'cui_str': 'Aqueous humor'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",23.0,0.350119,No statistically significant differences between treatment groups were observed for changes in any of the aqueous humor cytokines tested.,"[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kubota', 'Affiliation': 'Acucela Inc., 818 Stewart St., Suite 1110, Seattle, WA, 98101-1479, USA. RKubota@acucela.com.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Jhaveri', 'Affiliation': 'Retina Consultants of Austin, 3705 Medical Parkway, Suite 410, Austin, TX, 78705, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Koester', 'Affiliation': 'Acucela Inc., 818 Stewart St., Suite 1110, Seattle, WA, 98101-1479, USA.'}, {'ForeName': 'Jeffrey K', 'Initials': 'JK', 'LastName': 'Gregory', 'Affiliation': 'Acucela Inc., 818 Stewart St., Suite 1110, Seattle, WA, 98101-1479, USA.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04899-y']
2712,32852632,Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results.,"PURPOSE


The phase III COLUMBA study evaluated daratumumab (DARA) intravenous (IV) and subcutaneous (SC) in patients with relapsed or refractory multiple myeloma. Here, we report patient-reported satisfaction with therapy (SWT) in COLUMBA.
METHODS


DARA IV or DARA SC was administered weekly (cycles 1-2), every 2 weeks (cycles 3-6), and every 4 weeks (cycles 7 +). Patients completed a modified version of the Cancer Therapy Satisfaction Questionnaire (CTSQ) at weekly (cycles 1-2) and monthly (cycles 3 +) intervals and at the end of treatment. Results for each item and the SWT domain score were summarized using descriptive statistics. The distribution of responses for individual items was calculated for each assessment. The proportion of patients for whom SWT domain score change from first assessment met or exceeded the minimally important difference (MID) of 5.9 points was calculated at each assessment time point.
RESULTS


Two-hundred fifty-nine patients were randomized to DARA IV and 263 to DARA SC. Mean scores for SWT domain questions were high and largely positive during treatment. Responses indicating positive perceptions of therapy were given by a numerically greater proportion of patients in the DARA SC group than the DARA IV group for most questions. Changes from the first assessment in SWT domain scores met or exceeded the MID for an average of ~ 40% of patients.
CONCLUSION


In COLUMBA, modified CTSQ results suggest patients in the DARA SC group were more satisfied with their cancer therapy than those in the DARA IV group.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03277105. Registered September 8, 2107.",2020,Responses indicating positive perceptions of therapy were given by a numerically greater proportion of patients in the DARA SC group than the DARA IV group for most questions.,"['patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma', 'Two-hundred fifty-nine patients', 'patients with relapsed or refractory multiple myeloma']","['daratumumab (DARA) intravenous (IV) and subcutaneous (SC', 'DARA SC']",['Cancer Therapy Satisfaction Questionnaire (CTSQ'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",259.0,0.0315072,Responses indicating positive perceptions of therapy were given by a numerically greater proportion of patients in the DARA SC group than the DARA IV group for most questions.,"[{'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Plasma Cell Disorders Division, Clinical Research for Hematologic Malignancies, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute/Atrium Health, Charlotte, NC, USA. saad.usmani@atriumhealth.org.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL, Salamanca, Spain.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Clinica São Germano, São Paulo, Brazil.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Hareth', 'Initials': 'H', 'LastName': 'Nahi', 'Affiliation': 'Division of Hematology, Department of Medicine, Karolinska Institute, Karolinska University Hospital at Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Magen', 'Affiliation': 'Department of Hematology, Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': 'Department of Hematology, Hôpital Haut Lévêque, University Hospital, Pessac, France.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Dalhousie University and QEII Health Sciences Centre, Halifax, NS, Canada.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'De Stefano', 'Affiliation': 'Institute of Hematology, Catholic University, Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fastenau', 'Affiliation': 'Janssen Global Services, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Slavcev', 'Affiliation': 'Janssen Global Services, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Masterson', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lantz', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Katharine S', 'Initials': 'KS', 'LastName': 'Gries', 'Affiliation': 'Janssen Global Services, LLC, Raritan, NJ, USA.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03365-w']
2713,32852646,Pentacam corneal densitometry-guided treatment of adenoviral corneal subepithelial infiltrates: a comparative study between transepithelial phototherapeutic keratectomy and topical tacrolimus.,"PURPOSE


To compare the changes in the measurement of corneal densitometry and total corneal higher-order aberrations (HOAs) between topical tacrolimus and transepithelial phototherapeutic keratectomy (Te-PTK) in the treatment of adenoviral corneal subepithelial infiltrates (SEIs).
SUBJECT AND METHODS


This is an interventional prospective randomized study, including 63 eyes of 35 patients with symptomatic adenoviral corneal SEIs for at least 6 months. All patients underwent previous topical steroid therapy associated with unsatisfactory response and/or complications. Patients were assigned into three groups: (1) Te-PTK group: Te-PTK with MMC 0.02% was performed by a Technolas; Teneo excimer laser; (2) tacrolimus group: tacrolimus 0.03% ointment was applied once daily for 2-6 months; the endpoint of treatment was based on the improvement in the corneal densitometry, BCVA, and OSDI; and (3) control group: no intervention was done. BCVA, corneal densitometry, and total corneal higher-order aberrations (HOAs) evaluation using Pentacam HR were done at the baseline, 1 week, and then 1, 3, 6, and 12 months of the study.
RESULTS


The study population was similar between all groups. The mean follow-up was 12.75 ± 0.9 months. Bilateral corneal SEI was recorded at 80%. At 12-month follow-ups, the mean BCVA improved in both the Te-PTK and tacrolimus groups without significant changes in the control group. The mean corneal densitometry of the anterior, central, and total cornea decreased significantly in the Te-PTK and tacrolimus groups. HO-RMS and total RMS decreased significantly in the Te-PTK and tacrolimus groups. BCVA, corneal densitometry (anterior, central, and total cornea), and corneal aberrations (total coma, total trefoil, HO-RMS, and total RMS) values were significantly better for the Te-PTK and tacrolimus groups than the control group. There were no statistically significant differences between Te-PTK and tacrolimus groups in terms of BCVA, corneal densitometry, corneal HOA, and the persistence of corneal SEIs. The persistence of corneal SEIs was significantly lower in Te-PTK and tacrolimus groups than the control group.
CONCLUSION


Te-PTK and topical tacrolimus are effective methods for the treatment of adenoviral corneal SEIs improving visual acuity, corneal densitometry, and corneal HOA. The densitometry program of the Pentacam may give an objective guide for the treatment of adenoviral corneal SEIs.
TRIAL REGISTRATION


ClinicalTrials.gov ID is NCT04267991.",2020,"There were no statistically significant differences between Te-PTK and tacrolimus groups in terms of BCVA, corneal densitometry, corneal HOA, and the persistence of corneal SEIs.","['63 eyes of 35 patients with symptomatic adenoviral corneal SEIs for at least 6\xa0months', 'adenoviral corneal subepithelial infiltrates (SEIs', 'adenoviral corneal subepithelial infiltrates']","['topical steroid therapy', 'tacrolimus', 'Te-PTK group: Te-PTK with MMC 0.02% was performed by a Technolas', 'Pentacam corneal densitometry-guided treatment', 'topical tacrolimus and transepithelial phototherapeutic keratectomy (Te-PTK', 'Teneo excimer laser; (2) tacrolimus group: tacrolimus 0.03% ointment', 'transepithelial phototherapeutic keratectomy and topical tacrolimus']","['Bilateral corneal SEI', 'corneal densitometry, BCVA, and OSDI', 'corneal densitometry and total corneal higher-order aberrations (HOAs', 'mean BCVA', 'mean corneal densitometry of the anterior, central, and total cornea', 'HO-RMS and total RMS', 'visual acuity, corneal densitometry, and corneal HOA', 'persistence of corneal SEIs', 'unsatisfactory response and/or complications', 'BCVA, corneal densitometry (anterior, central, and total cornea), and corneal aberrations (total coma, total trefoil, HO-RMS, and total RMS) values', 'BCVA, corneal densitometry, corneal HOA, and the persistence of corneal SEIs', 'BCVA, corneal densitometry, and total corneal higher-order aberrations (HOAs) evaluation']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4760983', 'cui_str': 'Phototherapeutic keratectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0939241', 'cui_str': 'Tacrolimus-containing product in cutaneous dose form'}, {'cui': 'C0392265', 'cui_str': 'Excimer laser device'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0950061', 'cui_str': 'Trefoil'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",35.0,0.0227025,"There were no statistically significant differences between Te-PTK and tacrolimus groups in terms of BCVA, corneal densitometry, corneal HOA, and the persistence of corneal SEIs.","[{'ForeName': 'Tarek Roshdy', 'Initials': 'TR', 'LastName': 'Elhamaky', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Benha University, Benha, Qalubiya Governorate, 13511, Egypt. dr_thamakyy@yahoo.com.'}]",International ophthalmology,['10.1007/s10792-020-01553-8']
2714,32852696,Efficacy and Safety of Sitagliptin Compared with Dapagliflozin in People ≥ 65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency.,"INTRODUCTION


Older patients with type 2 diabetes (T2D) are at increased risk of diabetic nephropathy and mild renal insufficiency. This analysis compared the anti-hyperglycemic efficacy and safety of sitagliptin with dapagliflozin in patients ≥ 65 years of age with T2D and mild renal insufficiency.
METHODS


This was a post hoc analysis of data from 410 patients ≥ 65 years old who participated in a 24-week, randomized, double-blind clinical trial (CompoSIT-R [comparison of sitagliptin with dapagliflozin in mild renal impairment]; NCT02532855) in T2D patients with mild renal insufficiency and on metformin ± a sulfonylurea; the primary efficacy end point was change in HbA1c at week 24.
RESULTS


Treatment groups were well balanced at baseline (mean HbA1c = 7.7/7.7% and eGFR = 79/76 ml/min/1.73 m 2  for sitagliptin/dapagliflozin). At week 24, LS mean (95% CI) change in HbA1c and percentage of patients with HbA1c < 7% were greater with sitagliptin, - 0.48% and 41%, respectively, compared with dapagliflozin, - 0.36% and 28%; between-group differences = - 0.12% (- 0.36, 0.01) and 12.8% (3.3, 22.2) for change in HbA1c and percentage with HbA1c < 7%, respectively. The sitagliptin group had greater reductions in PPG end points, while the dapagliflozin group had greater reductions in FPG. Treatments were generally well tolerated. There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
CONCLUSIONS


In patients ≥ 65 years of age with T2D and mild renal insufficiency with inadequate glycemic control on metformin ± sulfonylurea, treatment with sitagliptin for 24 weeks resulted in improvement in HbA1c relative to treatment with dapagliflozin that is consistent with that previously observed in the overall population. Both treatments were generally well tolerated.",2020,"There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
","['patients\u2009≥\u200965\xa0years of age with T2D and mild renal insufficiency with inadequate glycemic control on metformin\u2009±\u2009sulfonylurea, treatment with sitagliptin for 24\xa0weeks', 'T2D patients with mild renal insufficiency and on metformin\u2009±\u2009a', 'Older patients with type 2 diabetes (T2D', '65\xa0years of age with T2D and mild renal insufficiency', 'People\u2009≥', '410 patients\u2009≥', '65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency', '65\xa0years old who participated', 'patients\u2009≥']","['Sitagliptin', 'Dapagliflozin', 'sitagliptin with dapagliflozin', 'sulfonylurea', 'dapagliflozin']","['FPG', 'tolerated', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.192702,"There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
","[{'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. annaswamy.raji@merck.com.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Raymond L H', 'Initials': 'RLH', 'LastName': 'Lam', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': ""O'Neill"", 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Kaufman', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00907-w']
2715,32845740,Safety and efficacy of galcanezumab in Taiwanese Patients: a post-hoc analysis of phase 3 studies in episodic and chronic migraine.,"Objective : Migraine is a chronic, disabling neurological disease affecting >1 billion people worldwide. Migraine remains undertreated in Asia, including Taiwan. Galcanezumab is a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide, a peptide firmly established in the pathophysiology of migraine, with demonstrated efficacy and safety in patients with episodic or chronic migraine. Our objective was to evaluate the efficacy and safety of galcanezumab in Taiwanese patients with episodic or chronic migraine. Methods :  We conducted a sub-group analysis of the Taiwanese cohort from two double-blind, placebo-controlled, Phase 3 clinical trials of galcanezumab in the prevention of episodic and chronic migraine, EVOLVE-2 (NCT02614196) and REGAIN (NCT02614261) respectively. During the EVOLVE-2 and REGAIN double-blind periods, 2092 patients were randomly assigned to receive monthly injections of either placebo, 120mg galcanezumab (240mg loading dose), or 240mg galcanezumab. In REGAIN, a 9-month open-label period followed. Post-hoc analysis on the Taiwanese population across both trials included 106 patients, 45 of whom continued into the open-label period in REGAIN. Results : Our findings show that galcanezumab has similar efficacy and safety in the Taiwanese population, as compared to the 'All Patients' population included in the study. Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with a ≥50% response, and positively impacted quality of life. Conclusion : Galcanezumab is a promising therapeutic for the preventive treatment of migraine in the Taiwanese population.",2020,"Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with a ≥50% response, and positively impacted quality of life.","['Taiwanese Patients', '2092 patients', '106 patients, 45 of whom continued into the open-label period in REGAIN', 'Taiwanese patients with episodic or chronic migraine', 'patients with episodic or chronic migraine', 'Migraine remains undertreated in Asia, including Taiwan']","['galcanezumab', 'placebo', 'Galcanezumab']","['Safety and efficacy', 'efficacy and safety', 'quality of life', 'number of monthly migraine headache days']","[{'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2092.0,0.145128,"Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with a ≥50% response, and positively impacted quality of life.","[{'ForeName': 'Chun-Pai', 'Initials': 'CP', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Kuang Tien General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chia-Fang', 'Initials': 'CF', 'LastName': 'Lee', 'Affiliation': 'Eli Lilly and Company, Taipei, Taiwan.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': ""Dell'Agnello"", 'Affiliation': 'Eli Lilly and Company, Sesto Fiorentino, Italy.'}, {'ForeName': 'Hans Peter', 'Initials': 'HP', 'LastName': 'Hundemer', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'Syneos Health, North Carolina, USA.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Neurological Institute, Taipei-Veterans General Hospital, Taipei, Taiwan.'}]",Current medical research and opinion,['10.1080/03007995.2020.1815181']
2716,32845782,"Immunogenicity and safety of the first indigenously developed Indian tetravalent influenza vaccine (split virion) in healthy children (6 months to 17 years of age): a randomized, multicenter, phase III clinical trial.","This phase III clinical trial was conducted to evaluate the immunogenicity and safety of the Tetravalent Influenza Vaccine (Split virion) I.P. (TetIV), containing two strains each of influenza A and B, developed indigenously in the country for the first time by M/s Cadila Healthcare Limited, India for use in the pediatric population (6 months -17 years of age), and compare it to that of a licensed seasonal Trivalent Influenza Vaccine (TriIV) of Sanofi Pasteur India Private Limited, containing two influenza A and one influenza B strains. Three hundred six subjects of either sex, 6 months to 17 years of age, were randomized in a 1:1 ratio to receive either TetIV or TriIV. Immunogenicity assessments (antibodies against A/H1N1, A/H3N2, B/Phuket, and B/Brisbane) were performed using the hemagglutination inhibition assay at baseline and 28 days after the last vaccination. TetIV was found to fulfill the criteria set by the United States Food and Drug Administration on the requirements of clinical data for licensure of seasonal inactivated influenza vaccines for the pediatric population. The seroconversion rates with TetIV were 94.6% for A/H1N1, 93.9% for A/H3N2, 91.2% for B/Brisbane, and 87.2% for B/Phuket strains. TetIV showed non-inferiority and superiority in immune response, as compared to TriIV, against the shared strains and an additional B strain, respectively. Both the vaccines were tolerated well by all the study participants, and an addition of the fourth strain in TetIV did not compromise the safety as compared to that of TriIV. The most common adverse event reported in both groups was fever.",2020,"TetIV showed non-inferiority and superiority in immune response, as compared to TriIV, against the shared strains and an additional B strain, respectively.","['healthy children (6 months to 17 years of age', 'Three hundred six subjects of either sex, 6\xa0months to 17\xa0years of age']","['TetIV or TriIV', 'Tetravalent Influenza Vaccine (Split virion) I.P', 'first indigenously developed Indian tetravalent influenza vaccine (split virion']","['Immunogenicity and safety', 'seroconversion rates with TetIV', 'immunogenicity and safety', 'Immunogenicity assessments (antibodies against A/H1N1, A/H3N2, B/Phuket, and B/Brisbane']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}]",306.0,0.0518531,"TetIV showed non-inferiority and superiority in immune response, as compared to TriIV, against the shared strains and an additional B strain, respectively.","[{'ForeName': 'Sumantra', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Department of Pediatrics, IPGMER & SSKM Hospital , Kolkata, India.'}, {'ForeName': 'Chandrakant', 'Initials': 'C', 'LastName': 'Bokade', 'Affiliation': 'Department of Pediatrics, Government Medical College and Hospital, Medical College Square , Nagpur, India.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Garg', 'Affiliation': 'Department of Paediatrics, Jay Kay Lon Hospital SMS Medical College , Jaipur, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, Niloufer Hospital (Affiliated to Osmania Medical College) , Hyderabad, India.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Sanmukhani', 'Affiliation': 'Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited , India.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Mittal', 'Affiliation': 'Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited , India.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1794683']
2717,32845800,Effects of mortality awareness on attitudes toward dying and death and meaning in life-a randomized controlled trial.,"A randomized controlled trial was carried out to investigate effects of heightened mortality awareness on meaning in life and attitudes toward dying and death. An intervention group ( n  = 51) completed questionnaires and participated in interventions to increase mortality awareness; a control group ( n  = 47) only completed the questionnaires. Longitudinal analyses revealed a decrease in the intervention group's fear of dying and an increase in their acceptance of dying, but no effects on attitudes toward death. Changes in meaningfulness were contingent on participants' religiousness. Unexpected cross-sectional results and the study's implications for theory and further empirical work are discussed.",2020,"Longitudinal analyses revealed a decrease in the intervention group's fear of dying and an increase in their acceptance of dying, but no effects on attitudes toward death.",[],[],"['attitudes toward death', 'meaning in life and attitudes toward dying and death', 'attitudes toward dying and death and meaning in life', 'mortality awareness']",[],[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0197491,"Longitudinal analyses revealed a decrease in the intervention group's fear of dying and an increase in their acceptance of dying, but no effects on attitudes toward death.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Spitzenstätter', 'Affiliation': 'Institute of Psychology, University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Schnell', 'Affiliation': 'Institute of Psychology, University of Innsbruck, Innsbruck, Austria.'}]",Death studies,['10.1080/07481187.2020.1808737']
2718,32845808,"Comparison of Bioabsorbable Steroid-Eluting Sinus Stents Versus Nasopore After Endoscopic Sinus Surgery: A Multicenter, Randomized, Controlled, Single-Blinded Clinical Trial.","OBJECTIVES


The aim of this study was to compare the efficacy of bioabsorbable steroid-eluting sinus stents versus absorbable Nasopore packs after endoscopic sinus surgery (ESS) for the treatment of chronic rhinosinusitis (CRS).
METHODS


One hundred eighty-one patients with CRS who underwent ESS were randomly assigned to receive a steroid-eluting sinus stent in one ethmoid sinus cavity, whereas the contralateral control side received a Nasopore pack. Endoscopic evaluations were performed 14, 30, and 90 days after the ESS. Postoperative intervention, polyp formation, adhesions, and middle turbinate (MT) position were assessed as efficacy outcomes.
RESULTS


The stents were successfully deployed in all 181 sinuses. Thirty days after the ESS, the stents significantly reduced the need for surgical intervention compared to the Nasopore ( P  < .0001). The percentage of cases with polyp formation was significantly lower on the stent sides compared with the Nasopore sides ( P  < .0001) at 14, 30, and 90 days after ESS. The percentage of severe adhesion was significantly lower on the stents sides than on the Nasopore sides at postoperative day 90 ( P  = .0003), whereas they were not significantly lower at postoperative days 14 and 30. There were no significant differences between the stent sides and the Nasopore sides regarding the frequency of MT lateralization at all end points. No device-related adverse events occurred.
CONCLUSIONS


Our study demonstrated significant improvement in the early postoperative outcomes by reducing the need for postoperative surgical intervention and polyp formation using steroid-eluting stents when compared with absorbable Nasopore packs. The steroid-eluting sinus stents and the Nasopore packs were each effective in preserving the ethmoid sinus patency and in preventing MT lateralization. A further prospective cohort study with long-term postoperative outcomes is warranted.",2020,"The percentage of severe adhesion was significantly lower on the stents sides than on the Nasopore sides at postoperative day 90 ( P  = .0003), whereas they were not significantly lower at postoperative days 14 and 30.","['One hundred eighty-one patients with CRS who underwent ESS', 'chronic rhinosinusitis (CRS']","['Bioabsorbable Steroid-Eluting Sinus Stents', 'steroid-eluting sinus stent in one ethmoid sinus cavity, whereas the contralateral control side received a Nasopore pack', 'bioabsorbable steroid-eluting sinus stents versus absorbable Nasopore packs after endoscopic sinus surgery (ESS', 'Nasopore']","['Endoscopic evaluations', 'efficacy outcomes', 'percentage of severe adhesion', 'frequency of MT lateralization', 'percentage of cases with polyp formation', 'Postoperative intervention, polyp formation, adhesions, and middle turbinate (MT) position']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0015028', 'cui_str': 'Ethmoid sinus structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",181.0,0.0292415,"The percentage of severe adhesion was significantly lower on the stents sides than on the Nasopore sides at postoperative day 90 ( P  = .0003), whereas they were not significantly lower at postoperative days 14 and 30.","[{'ForeName': 'Zhenxiao', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Dehui', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Eye, Ear, Nose and Throat Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Hongrui', 'Initials': 'H', 'LastName': 'Zang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Huankang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Eye, Ear, Nose and Throat Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Eye, Ear, Nose and Throat Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shenqing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Jiangsu Province Hospital, Nanjing, Jiangsu, People's Republic of China.""}, {'ForeName': 'Jinrang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The Six Medical Center of PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, General Hospital of Tianjin Medical University, Tianjin, People's Republic of China.""}, {'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Emergency General Hospital, Beijing, People's Republic of China.""}]","Ear, nose, & throat journal",['10.1177/0145561320947632']
2719,32855110,"Quantification, epitope mapping and genotype cross-reactivity of hepatitis B preS-specific antibodies in subjects vaccinated with different dosage regimens of BM32.","BACKGROUND


Chronic hepatitis B virus (HBV) infections are a global health problem. There is a need for therapeutic strategies blocking continuous infection of liver cells. The grass pollen allergy vaccine BM32 containing the preS domain of the large HBV surface protein (LHBs) as immunogenic carrier induced IgG antibodies in human subjects inhibiting HBV infection in vitro. Aim of this study was the quantification, epitope mapping and investigation of HBV genotype cross-reactivity of preS-specific antibodies in subjects treated with different dosage regimens of BM32 METHODS: Hundred twenty eight grass pollen allergic patients received in a double-blind, placebo-controlled trial five monthly injections of placebo (aluminum hydroxide, n= 34) or different courses of BM32 (2 placebo + 3 BM32, n= 33; 1 placebo + 4 BM32, n= 30; 5 BM32, n= 31). Recombinant Escherichia coli-expressed preS was purified. Overlapping peptides spanning preS and the receptor-binding sites from consensus sequences of genotypes A-H were synthesized and purified. Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides were determined by ELISA at baseline, one and four months after the last injection. IgG 1  and IgG 4  subclass concentrations specific for preS and the receptor-binding site were measured by quantitative ELISA.
FINDINGS


Five monthly injections induced the highest levels of preS-specific IgG consisting mainly of IgG 1  and IgG 4 , with a sum of median preS-specific IgG 1  and IgG 4  concentrations of >135 μg/ml reaching up to 1.8 mg/ml. More than 20% of preS-specific IgG was directed against the receptor-binding site. BM32-induced IgG cross-reacted with the receptor-binding domains from all eight HBV genotypes A-H.
INTERPRETATION


BM32 induces high levels of IgG 1  and IgG 4  antibodies against the receptor binding sites of all eight HBV genotypes and hence might be suitable for therapeutic HBV vaccination.
FUNDING


This study was supported by the PhD program IAI (KPW01212FW), by Viravaxx AG and by the Danube-ARC funded by the Government of Lower Austria. Rudolf Valenta is a recipient of a Megagrant of the Government of the Russian Federation, grant No 14.W03.31.0024.",2020,"Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides were determined by ELISA at baseline, one and four months after the last injection.","['subjects vaccinated with different dosage regimens of BM32', 'subjects treated with different dosage regimens of BM32 METHODS', 'Hundred twenty eight grass pollen allergic patients']","['placebo (aluminum hydroxide, n= 34) or different courses of BM32 (2 placebo + 3 BM32, n= 33; 1 placebo', 'placebo', 'Recombinant Escherichia coli-expressed preS']","['Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0021017', 'cui_str': 'Immunoglobulin isotype'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C1275917', 'cui_str': 'Immunoglobulin G subclass'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]",,0.143774,"Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides were determined by ELISA at baseline, one and four months after the last injection.","[{'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Tulaeva', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria; Department of Clinical Immunology and Allergology, I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Cornelius', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmutz', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Focke-Tejkl', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Karaulov', 'Affiliation': 'Department of Clinical Immunology and Allergology, I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Henning', 'Affiliation': 'Viravaxx, Vienna, Austria.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Valenta', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria; Department of Clinical Immunology and Allergology, I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation; NRC Institute of Immunology FMBA of Russia, Moscow, Russian Federation; Karl Landsteiner University of Health Sciences, Krems, Austria. Electronic address: rudolf.valenta@meduniwien.ac.at.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102953']
2720,32855156,Precision Medicine Stumbles in Umbrella Trial.,"The National Lung Matrix Trial, an umbrella trial of targeted therapies in non-small cell lung cancer, revealed that most drugs prescribed based on specific genomic aberrations showed little efficacy, but new approaches could bolster precision medicine.",2020,"The National Lung Matrix Trial, an umbrella trial of targeted therapies in non-small cell lung cancer, revealed that most drugs prescribed based on specific genomic aberrations showed little efficacy, but new approaches could bolster precision medicine.",['non-small cell lung cancer'],[],[],"[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]",[],[],,0.0587242,"The National Lung Matrix Trial, an umbrella trial of targeted therapies in non-small cell lung cancer, revealed that most drugs prescribed based on specific genomic aberrations showed little efficacy, but new approaches could bolster precision medicine.",[],Cancer discovery,['10.1158/2159-8290.CD-NB2020-082']
2721,32855160,Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting.,"OBJECTIVE


The current standard for hospital glucose management is point-of-care (POC) testing. We conducted a randomized controlled trial of real-time CGM (RT-CGM) compared with POC in a non-ICU hospital setting.
RESEARCH DESIGN AND METHODS


A total of 110 adults with type 2 diabetes (T2D) on a non-ICU floor received RT-CGM with Dexcom G6 versus usual care (UC). RT-CGM data were wirelessly transmitted from the bedside. Hospital telemetry monitored RT-CGM data and notified bedside nursing of glucose alerts and trends. Standardized protocols were used for interventions.
RESULTS


The RT-CGM group demonstrated significantly lower mean glucose (M∆ = -18.5 mg/dL) and percentage of time in hyperglycemia >250 mg/dL (-11.41%) and higher median time in range 70-250 mg/dL (+11.26%) compared with UC ( P s < 0.05). Percentage of time in hypoglycemia was very low.
CONCLUSIONS


RT-CGM can be used successfully in community-based hospital non-ICU settings to improve glucose management. Continuously streaming glucose readings may truly be the fifth vital sign.",2020,The RT-CGM group demonstrated significantly lower mean glucose,"['110 adults with type 2 diabetes (T2D) on a non-ICU floor received', 'in a Non-ICU Hospital Setting']","['RT-CGM', 'RT-CGM with Dexcom G6 versus usual care (UC', 'real-time CGM (RT-CGM', 'Continuous Glucose Monitoring']","['Percentage of time in hypoglycemia', 'percentage of time in hyperglycemia', 'higher median time', 'mean glucose']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",110.0,0.0208514,The RT-CGM group demonstrated significantly lower mean glucose,"[{'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Spierling Bagsic', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Talavera', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Isabel Maria', 'Initials': 'IM', 'LastName': 'Garcia', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Amiry', 'Initials': 'A', 'LastName': 'Hottinger', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA tsimikas.athena@scrippshealth.org.'}]",Diabetes care,['10.2337/dc20-1016']
2722,32855201,Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial.,"OBJECTIVES


To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up.
DESIGN


Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial.
SETTING


Orthopaedic departments in five public hospitals in Finland.
PARTICIPANTS


146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised.
INTERVENTIONS


APM or placebo surgery (diagnostic knee arthroscopy).
MAIN OUTCOME MEASURES


We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale).
RESULTS


There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar.
CONCLUSIONS


APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01052233 and NCT00549172).",2020,"There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively.","['146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised', 'Orthopaedic departments in five public hospitals in Finland']","['Arthroscopic partial meniscectomy', 'APM or placebo surgery (diagnostic knee arthroscopy', 'placebo', 'arthroscopic partial meniscectomy (APM']","['progression of radiographic knee osteoarthritis', 'risk of developing radiographic knee osteoarthritis', 'Lysholm knee score', 'mechanical symptoms', 'Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score', 'radiographic knee osteoarthritis', 'knee pain', 'knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scoring Scale'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",146.0,0.385234,"There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively.","[{'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Sihvonen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pihlajalinna Oyj, Tampere, Pirkanmaa, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Department of Orthopedics and Traumatology, Töölö Hospital, Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Malmivaara', 'Affiliation': 'Centre for Health and Social Economics - CHESS, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Itälä', 'Affiliation': 'Pohjola Hospital, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Joukainen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kalske', 'Affiliation': 'Department of Orthopedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Nurmi', 'Affiliation': 'Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Jaanika', 'Initials': 'J', 'LastName': 'Kumm', 'Affiliation': 'Department of Medicine, Tartu Ulikool, Tartu, Tartumaa, Estonia.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Sillanpää', 'Affiliation': 'Medical Imaging Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Kiekara', 'Affiliation': 'Medical Imaging Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Department of Orthopedics, Lund University, Lund, Sweden.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Englund', 'Affiliation': 'Clinical Epidemiology Unit, Orthopaedics, Lund University, Lund, Sweden.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland teppo.jarvinen@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of sports medicine,['10.1136/bjsports-2020-102813']
2723,32855385,Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trial.,"No effective drug treatments are available for coronavirus disease 2019 (COVID-19). Host-directed therapies targeting the underlying aberrant immune responses leading to pulmonary tissue damage, death, or long-term functional disability in survivors require clinical evaluation. We performed a parallel assigned controlled, non-randomized, phase 1 clinical trial to evaluate the safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusions in the treatment of patients with moderate and severe COVID-19 pulmonary disease. The study enrolled 18 hospitalized patients with COVID-19 (n = 9 for each group). The treatment group received three cycles of intravenous infusion of UC-MSCs (3 × 10 7  cells per infusion) on days 0, 3, and 6. Both groups received standard COVID-treatment regimens. Adverse events, duration of clinical symptoms, laboratory parameters, length of hospitalization, serial chest computed tomography (CT) images, the PaO 2 /FiO 2  ratio, dynamics of cytokines, and IgG and IgM anti-SARS-CoV-2 antibodies were analyzed. No serious UC-MSCs infusion-associated adverse events were observed. Two patients receiving UC-MSCs developed transient facial flushing and fever, and one patient developed transient hypoxia at 12 h post UC-MSCs transfusion. Mechanical ventilation was required in one patient in the treatment group compared with four in the control group. All patients recovered and were discharged. Our data show that intravenous UC-MSCs infusion in patients with moderate and severe COVID-19 is safe and well tolerated. Phase 2/3 randomized, controlled, double-blinded trials with long-term follow-up are needed to evaluate the therapeutic use of UC-MSCs to reduce deaths and improve long-term treatment outcomes in patients with serious COVID-19.",2020,Mechanical ventilation was required in one patient in the treatment group compared with four in the control group.,"['patients with moderate and severe COVID-19 pulmonary disease', 'patients with COVID-19', '18 hospitalized patients with COVID-19 (n\u2009=\u20099 for each group', 'patients with serious COVID-19']","['Human umbilical cord-derived mesenchymal stem cell therapy', 'human umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusions', 'standard COVID-treatment regimens', 'intravenous infusion of UC-MSCs']","['serious UC-MSCs infusion-associated adverse events', 'transient hypoxia', 'transient facial flushing and fever', 'safe and well tolerated', 'Mechanical ventilation', 'Adverse events, duration of clinical symptoms, laboratory parameters, length of hospitalization, serial chest computed tomography (CT) images, the PaO 2 /FiO 2  ratio, dynamics of cytokines, and IgG and IgM anti-SARS-CoV-2 antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",18.0,0.132743,Mechanical ventilation was required in one patient in the treatment group compared with four in the control group.,"[{'ForeName': 'Fanping', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Ruonan', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Junliang', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Tianjun', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Ji-Yuan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Jinwen', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Chunbao', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Maeurer', 'Affiliation': 'Immunotherapy Programme, Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Alimuddin', 'Initials': 'A', 'LastName': 'Zumla', 'Affiliation': 'Department of Infection, Division of Infection and Immunity, University College London, London, UK.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China. shiming302@sina.com.'}, {'ForeName': 'Fu-Sheng', 'Initials': 'FS', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China. fswang302@163.com.'}]",Signal transduction and targeted therapy,['10.1038/s41392-020-00286-5']
2724,32855580,"Effects of a Concept-Based Physical Education on Middle School Students' Knowledge, Motivation, and Out-of-School Physical Activity.","Purpose


This study aimed to determine the extent to which a concept-based physical education curriculum, specifically the Science of Healthful Living (SHL) curriculum, influenced middle school students' knowledge, motivation for physical education (PE) and physical activity (PA), and out-of-school PA.
Methods


A static group comparison design was adopted to analyze the differences on fitness knowledge, autonomous motivation for PE and PA, and out-of-school PA between eighth-grade students who studied the SHL curriculum (the experimental condition,  n  = 168) and their peers who studied a multiactivity PE (the control condition,  n  = 226) 1 year earlier.
Results


The students who studied the SHL curriculum demonstrated significantly higher levels of knowledge ( p  < .05, Cohen  d  = 0.81), autonomous motivation toward PA ( p  < .05, Cohen  d  = 0.20), and out-of-school PA ( p  < .05, Mann-Whitney  U  effect size = 0.01) than students who had experienced the multiactivity PE. The students in both conditions were equally motivated in their respective PE courses.
Conclusion


The SHL curriculum is effective in promoting students' PA behavior outside of the school.",2020,"The students who studied the SHL curriculum demonstrated significantly higher levels of knowledge ( p  < .05, Cohen  d  = 0.81), autonomous motivation toward PA ( p  < .05, Cohen  d  = 0.20), and out-of-school PA ( p  < .05, Mann-Whitney  U  effect size = 0.01) than students who had experienced the multiactivity PE.","['Middle School Students', 'between eighth-grade students who studied the SHL curriculum (the experimental condition,  n  = 168) and their peers who studied a multiactivity PE (the control condition,  n  = 226) 1 year earlier', 'middle school students']","['Concept-Based Physical Education', 'Healthful Living (SHL) curriculum', 'SHL curriculum']","['fitness knowledge, autonomous motivation for PE and PA, and out-of-school PA', 'levels of knowledge', 'autonomous motivation toward PA', 'knowledge, motivation for physical education (PE) and physical activity (PA), and out-of-school PA', 'Knowledge, Motivation, and Out-of-School Physical Activity']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0130637,"The students who studied the SHL curriculum demonstrated significantly higher levels of knowledge ( p  < .05, Cohen  d  = 0.81), autonomous motivation toward PA ( p  < .05, Cohen  d  = 0.20), and out-of-school PA ( p  < .05, Mann-Whitney  U  effect size = 0.01) than students who had experienced the multiactivity PE.","[{'ForeName': 'Yubing', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of Wisconsin-Whitewater, Whitewater, WI.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina-Greensboro, Greensboro, NC.'}]",Journal of teaching in physical education : JTPE,['10.1123/jtpe.2019-0067']
2725,32855579,Cooperative Learning Effects on Peer Relations and Alcohol Use in Middle School.,"We tested a prevention approach aimed at reducing growth in alcohol use in middle school using four waves (2 years) of data from a cluster randomized trial ( N  = 15 middle schools, 1,890 students, 47.1% female, 75.2% White). Our approach exposed students to a broad cross-section of peers through collaborative, group-based learning activities in school (i.e.,  cooperative learning ). We hypothesized that the increased social contact created by cooperative learning would promote greater peer relatedness, interrupting the process of deviant peer clustering and, in turn, reduce escalations in alcohol use. Our results supported these hypotheses, suggesting that the social nature of cooperative learning, and the emphasis on group work and collaboration, can provide social and behavioral as well as academic benefits for students.",2019,We tested a prevention approach aimed at reducing growth in alcohol use in middle school using four waves (2 years) of data from a cluster randomized trial (,"['Middle School', 'middle school using four waves (2 years) of data from a cluster randomized trial ', 'N  = 15 middle schools, 1,890 students, 47.1% female, 75.2% White']",[],[],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],[],1890.0,0.0158929,We tested a prevention approach aimed at reducing growth in alcohol use in middle school using four waves (2 years) of data from a cluster randomized trial (,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Cary J', 'Initials': 'CJ', 'LastName': 'Roseth', 'Affiliation': 'Michigan State University, East Lansing, MI.'}]",Journal of applied developmental psychology,['10.1016/j.appdev.2019.101059']
2726,32855590,Lessons Learned About Barriers to Implementing School-Based Interventions for Adolescents: Ideas for Enhancing Future Research and Clinical Projects.,"The majority of youth with mental health problems do not receive treatment, highlighting the critical need to transport evidence-based interventions into community settings, such as schools. Despite being able to reach a large number of adolescents and minority youth, the process of implementing evidence-based interventions to schools is challenging. This paper discusses some expected and unexpected challenges experienced during the implementation of an open trial and a pilot randomized controlled trial examining the acceptability and effectiveness of a school-based preventive intervention for adolescents at risk for internalizing disorders. First, we highlight key programs and findings on preventive interventions for adolescents at risk for depression and anxiety. Next, we provide a brief overview of the preventive intervention we implemented in schools. This provides a context for the section that describes implementation issues and highlights specific challenges and potential solutions for intervention implementation. Finally, the paper offers recommendations for researchers and clinicians interested in implementing school-based mental health services for adolescents.",2019,"The majority of youth with mental health problems do not receive treatment, highlighting the critical need to transport evidence-based interventions into community settings, such as schools.","['Adolescents', 'adolescents at risk for depression and anxiety', 'adolescents', 'adolescents at risk for internalizing disorders']",['school-based preventive intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],,0.0301544,"The majority of youth with mental health problems do not receive treatment, highlighting the critical need to transport evidence-based interventions into community settings, such as schools.","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Girio-Herrera', 'Affiliation': 'Towson University.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Ehrlich', 'Affiliation': 'University of Miami.'}, {'ForeName': 'BreAnne A', 'Initials': 'BA', 'LastName': 'Danzi', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'La Greca', 'Affiliation': 'University of Miami.'}]",Cognitive and behavioral practice,['10.1016/j.cbpra.2018.11.004']
2727,32855648,The Effect of Electroacupuncture on Dynamic Balance during Stair Climbing for Elderly Patients with Knee Osteoarthritis.,"Background


Poor balance is one of the risk factors for falls in patients with knee osteoarthritis (KOA), which is related to the symptoms. Electroacupuncture (EA) is one of the traditional Chinese conservative methods commonly used to improve the symptoms in patients with KOA.
Objective


To assess whether EA increases the dynamic balance during stair negotiation among patients with KOA.
Methods


A total of 40 KOA patients were assigned to two groups randomly (true electroacupuncture vs. mock electroacupuncture). Acupoints around the knee were selected in the true electroacupuncture (TEA) group with electrical stimulation (2 Hz). In the mock electroacupuncture (MEA) group, about 2 cm next to the above acupoints, the needles were inserted superficially without electrical stimulation. All the participants received 11 sessions of stimulation treatment in three weeks. The primary outcome was margin of stability (MOS). Secondary outcomes included hip kinematics and kinetics as well as pain.
Results


There was no significant difference between the two groups for self-reported pain ( p =0.585). During ascent, there was no difference between groups in MOS value in both directions, which was the anterior-posterior (A/P) direction and medial-lateral (M/L) direction at initial contact and toe-off as well as the midstance in the gait cycle, and no difference for the hip kinematics and kinetics between the groups was detected ( p  > 0.05). For descent, at the toe-off event, the TEA group was more unstable as compared to the MEA group in the A/P direction ( p =0.029) but not in the M/L direction, and the hip showed a larger internal rotator moment ( p =0.049); at the midstance, the TEA group showed a lower abductor moment than the MEA group ( p =0.003).
Conclusions


Based on the assessment results from the chosen patients with KOA, the TEA did not demonstrate a significant effect in improving the dynamic balance during stair negotiation in comparison with the MEA. This finding does not support EA as a conservative treatment to improve the dynamic balance in such patients.",2020,"During ascent, there was no difference between groups in MOS value in both directions, which was the anterior-posterior (A/P) direction and medial-lateral (M/L) direction at initial contact and toe-off as well as the midstance in the gait cycle, and no difference for the hip kinematics and kinetics between the groups was detected ( p  > 0.05).","['patients with knee osteoarthritis (KOA', 'Elderly Patients with Knee Osteoarthritis', '40 KOA patients', 'patients with KOA']","['Electroacupuncture (EA', 'electroacupuncture (MEA', 'Electroacupuncture', 'EA', 'electroacupuncture vs. mock electroacupuncture', 'electroacupuncture (TEA) group with electrical stimulation', 'TEA', 'MEA']","['larger internal rotator moment', 'MOS value', 'hip kinematics and kinetics as well as pain', 'Dynamic Balance', 'self-reported pain', 'lower abductor moment', 'margin of stability (MOS', 'dynamic balance', 'hip kinematics and kinetics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",40.0,0.0336013,"During ascent, there was no difference between groups in MOS value in both directions, which was the anterior-posterior (A/P) direction and medial-lateral (M/L) direction at initial contact and toe-off as well as the midstance in the gait cycle, and no difference for the hip kinematics and kinetics between the groups was detected ( p  > 0.05).","[{'ForeName': 'Meijin', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'National Joint Engineering Research Centre of Rehabilitation Medicine Technology, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, Longyan, China.'}, {'ForeName': 'Shengxing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Fengjiao', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Zhenhui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, Fujian 350122, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/3563584']
2728,32855698,Clinical efficacy of conjoint fascial sheath suspension and frontalis muscle suspension in treating moderate or severe congenital ptosis and the effects on ocular surface and refractive status.,"Clinical efficacy of conjoint fascial sheath suspension and frontalis muscle suspension was explored in treating moderate or severe congenital ptosis and their effects on ocular surface and refractive status. A total of 75 patients with moderate or severe ptosis (108 eyes) treated in Yidu Central hospital from June 2014 to June 2019 were enrolled in this study, and divided into group A and group B. Group A was treated with conjoint fascial sheath suspension (n=38, 55 eyes), while group B was treated with frontalis muscle suspension (n=37, 53 eyes). The following data of the two groups were compared: General baseline data, total correction efficiency, satisfaction, and ocular surface after surgery, refractive status, and complications at three months after surgery. The two groups showed no significant difference in general data (P>0.05), but group A showed higher total correction efficiency and satisfaction, and less complications than those in group B (all P<0.05). In addition, the two groups had no difference in terms of ocular surface, tear break-up time, or Schirmer test level after surgery (all P>0.05), and showed no refraction changes after surgery (P>0.05). In terms of refractive status and ocular surface, the two surgery methods are not very different, but in terms of efficacy, conjoint fascial sheath suspension is more advantageous than frontalis muscle suspension, and it brings less complications, and enjoys a higher satisfaction, so it is worthy of promotion.",2020,"In addition, the two groups had no difference in terms of ocular surface, tear break-up time, or Schirmer test level after surgery (all P>0.05), and showed no refraction changes after surgery (P>0.05).",['75 patients with moderate or severe ptosis (108 eyes) treated in Yidu Central hospital from June 2014 to June 2019'],"['conjoint fascial sheath suspension', 'frontalis muscle suspension', 'conjoint fascial sheath suspension and frontalis muscle suspension']","['total correction efficiency and satisfaction, and less complications', 'General baseline data, total correction efficiency, satisfaction, and ocular surface after surgery, refractive status, and complications', 'ocular surface, tear break-up time, or Schirmer test level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224110', 'cui_str': 'Structure of frontal belly of occipitofrontalis muscle'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",75.0,0.0183396,"In addition, the two groups had no difference in terms of ocular surface, tear break-up time, or Schirmer test level after surgery (all P>0.05), and showed no refraction changes after surgery (P>0.05).","[{'ForeName': 'Xuehong', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Medical Aesthetics, Yidu Central Hospital, Qingzhou, Shandong 262500, P.R. China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wei', 'Affiliation': 'Department of Acupuncture and Moxibustion, Qingzhou Traditional Chinese Medicine Hospital, Qingzhou, Shandong 262500, P.R. China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Aesthetics, Yidu Central Hospital, Qingzhou, Shandong 262500, P.R. China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Burn and Plastic Surgery, Zibo Central Hospital, Zibo, Shandong 255036, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9053']
2729,32855737,Dexmedetomidine improves early postoperative neurocognitive disorder in elderly male patients undergoing thoracoscopic lobectomy.,"Perioperative neurocognitive disorder (PND) is a common complication following thoracic surgery that frequently occurs in patients ≥65 years. PND includes postoperative cognitive dysfunction (POCD) and postoperative delirium (POD). To investigate whether intravenous dexmedetomidine (DEX) is able to improve neurocognitive function in elderly male patients following thoracoscopic lobectomy, a randomized, double-blinded, placebo-controlled trial was performed at the Affiliated Hospital of Inner Mongolia Medical University (Hohhot, China). Patients aged ≥65 years were enrolled and were subjected to thoracic surgery under general anesthesia. A computer-generated randomization sequence was used to randomly assign patients (at a 1:1 ratio) to receive either intravenous DEX (0.5 µg/kg per h, from induction until chest closure) or placebo (intravenous normal saline). The primary endpoint was the result of the Mini-Mental State Examination (MMSE). The secondary endpoints were the results of the Montreal Cognitive Assessment (MoCA) and those obtained with the Confusion Assessment Method (CAM), as well as the incidence of POCD and POD during the first 7 postoperative days. Other observational indexes included sleep quality at night, self-anxiety scale prior to the operation and 7 days following the operation and the visual analogue scale (VAS) score at rest and during movement on the first and third day following the operation. Furthermore, at 6 h following surgery, the MMSE score in the DEX group was significantly higher than that in the saline group. At 6 h and on the first day postoperatively, the MoCA score in the DEX group was significantly higher than that in the saline group. The incidence of POCD and POD in the DEX group was 13.2 and 7.5%, respectively, while that in the saline group was 35.8 and 11.3%, respectively. There was a significant difference in the incidence of POCD between the two groups (P<0.01). In the DEX group, mean sleep quality was increased, whereas the mean VAS was decreased compared with the corresponding values in the saline group. In conclusion, elderly male patients who underwent thoracoscopic lobectomy under continuous infusion of DEX (0.5 µg/kg/h) exhibited a reduced incidence of POCD during the first 7 postoperative days as compared with the placebo group. Furthermore, DEX improved the subjective sleep quality in the first postoperative night, reduced anxiety and alleviated postoperative pain. In addition, it increased the incidence of bradycardia. The present study was registered in the Chinese Clinical Trial Registry (www.chictr.org.cn; registration no. ChiCTR-IPR-17010958).",2020,"At 6 h and on the first day postoperatively, the MoCA score in the DEX group was significantly higher than that in the saline group.","['elderly male patients undergoing thoracoscopic lobectomy', 'elderly male patients following thoracoscopic lobectomy', 'patients ≥65 years', 'Patients aged ≥65 years', 'elderly male patients who underwent', 'controlled trial was performed at the Affiliated Hospital of Inner Mongolia Medical University (Hohhot, China']","['intravenous DEX', 'thoracic surgery under general anesthesia', 'DEX', 'placebo (intravenous normal saline', 'Dexmedetomidine', 'placebo', 'dexmedetomidine (DEX', 'thoracoscopic lobectomy']","['Perioperative neurocognitive disorder (PND', 'subjective sleep quality', 'incidence of POCD', 'anxiety and alleviated postoperative pain', 'early postoperative neurocognitive disorder', 'neurocognitive function', 'sleep quality at night, self-anxiety scale prior to the operation and 7 days following the operation and the visual analogue scale (VAS) score', 'mean VAS', 'Montreal Cognitive Assessment (MoCA) and those obtained with the Confusion Assessment Method (CAM), as well as the incidence of POCD and POD', 'MMSE score', 'postoperative cognitive dysfunction (POCD) and postoperative delirium (POD', 'incidence of bradycardia', 'MoCA score', 'result of the Mini-Mental State Examination (MMSE', 'mean sleep quality', 'incidence of POCD and POD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}]","[{'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]",,0.0960707,"At 6 h and on the first day postoperatively, the MoCA score in the DEX group was significantly higher than that in the saline group.","[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Anesthesia and Operation Center, Chinese PLA General Hospital, Beijing 100853, P.R. China.'}, {'ForeName': 'Xuejiang', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia 010050, P.R. China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia 010050, P.R. China.'}, {'ForeName': 'Yajuan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia 010050, P.R. China.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Xv', 'Affiliation': 'Anesthesia and Operation Center, Chinese PLA General Hospital, Beijing 100853, P.R. China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mi', 'Affiliation': 'Anesthesia and Operation Center, Chinese PLA General Hospital, Beijing 100853, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9113']
2730,32855815,Development and feasibility of a tailored habit-based dietary intervention coupled with natural tooth replacement on the nutritional status of older patients.,"Background


Older adults suffering partial tooth loss may need additional intervention strategies other than natural tooth replacement alone to improve their nutritional status. This study aimed to design and develop a habit-based tailored dietary intervention and to assess the feasibility and acceptability of the intervention, in conjunction with natural tooth replacement, amongst partially dentate older adults.
Methods


The design and development of the dietary intervention (phase 1) consisted of analysis of the target population's dietary intake and qualitative research through focus groups with community-dwelling older adults (aged 65 years and over). The dietary intervention consisted of forming three healthy dietary habits around fruits and vegetables, wholegrains and healthy proteins. Feasibility of the intervention was then tested amongst older adults who had recently completed dental treatment for natural tooth replacement in a small non-randomised single arm study (phase 2). The principal feasibility outcome was the usability and acceptability of the intervention which was measured using evaluation questionnaires and by conducting post-intervention semi-structured interviews. Supporting outcomes consisted of feasibility of screening procedures, recruitment strategies and retention/attrition rates as well as the participant's compliance to the intervention assessed through self-monitoring tracking sheets.
Results


Twenty-one older adults (mean [SD] age 72.1 [10.4].) took part in one of four focus group discussions (phase 1). Twelve themes related to barriers (e.g. oral health, appetite) and facilitators (e.g. nutritional knowledge, retirement) of healthy eating guided intervention development, as did a further five themes when asked for direct intervention feedback. Nine older adult participants (mean [SD] age 72.5[9.7]) were recruited into the feasibility study (phase 2) where eight themes were identified from feedback interview discussions. The principal outcome measures identified intervention feasibility as participants considered the intervention acceptable and useable as both the evaluation questionnaire and qualitative interview results were overwhelmingly positive. As a supporting outcome measure, strong intervention compliance was also achieved. Screening procedures were accepted but additional recruitment strategies (e.g. incorporation of home study visits or recruitment via posters advertisement) may benefit future study enrolment and retention.
Conclusion


Phase 1 and phase 2 findings have allowed for an iterative, user-driven intervention to be developed and refined for a randomised control study to evaluate the intervention's effectiveness.
Trial registration


ISRCTN66118345.",2020,"Conclusion


Phase 1 and phase 2 findings have allowed for an iterative, user-driven intervention to be developed and refined for a randomised control study to evaluate the intervention's effectiveness.
","['\n\n\nOlder adults suffering partial tooth loss', 'older adults who had recently completed dental treatment for natural tooth replacement in a small non-randomised single arm study (phase 2', 'Results\n\n\nTwenty-one older adults (mean [SD] age 72.1 [10.4', 'older patients', 'groups with community-dwelling older adults (aged 65 years and over', 'Nine older adult participants (mean [SD] age 72.5[9.7', 'partially dentate older adults']","['dietary intervention consisted of forming three healthy dietary habits around fruits and vegetables, wholegrains and healthy proteins', ""dietary intervention (phase 1) consisted of analysis of the target population's dietary intake and qualitative research through focus"", 'habit-based tailored dietary intervention', 'tailored habit-based dietary intervention coupled with natural tooth replacement']","['feasibility and acceptability', 'usability and acceptability', 'intervention acceptable and useable as both the evaluation questionnaire and qualitative interview results']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",3.0,0.042902,"Conclusion


Phase 1 and phase 2 findings have allowed for an iterative, user-driven intervention to be developed and refined for a randomised control study to evaluate the intervention's effectiveness.
","[{'ForeName': 'Leigh-Ann', 'Initials': 'LA', 'LastName': 'McCrum', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Watson', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McGowan', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'McGuinness', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cardwell', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}, {'ForeName': 'Jayne V', 'Initials': 'JV', 'LastName': 'Woodside', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'McKenna', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.""}]",Pilot and feasibility studies,['10.1186/s40814-020-00654-6']
2731,32855874,Intravitreal Injection with a Conjunctival Injection Device: A Single-Center Experience.,"Purpose


To evaluate the clinical performance of the intravitreal injection assistant device (InVitria) compared with the conventional freehand technique for delivering intravitreal injections.
Methods


Seventy patients were randomized to receive intravitreal injections via the conventional freehand technique while 70 received injections using the InVitria. Half of all procedures in each group were performed by junior surgeons, while the rest were performed by senior surgeons.
Results


Mean injections times were 90.0 ± 23.3 seconds and 64.9 ± 26.8 seconds for conventional versus InVitria ( P  < 0.001). Mean injection times with the conventional technique were 85.5 ± 23.0 seconds vs. 94.2 ± 23.0 seconds for senior versus junior surgeons ( P  = 0.120). Mean injection times with the InVitria were 56.1 ± 26.1 seconds vs. 66.3 ± 26.9 seconds ( P  = 0.211) for senior versus junior surgeons. There were no significant differences in pain scores regardless of technique (conventional versus In Vitria: 2.03 ± 1.73 vs. 2.13 ± 2.20,  P  = 0.770).
Conclusions


In our experience, the InVitria is a comparable alternative to the conventional freehand technique of delivering intravitreal injections, with the potential for faster injection times and without compromising on patient comfort.
Translational Relevance


The study provides evidence to suggest that the InVitria may be deployed effectively in clinical practice.",2020,Mean injection times with the conventional technique were 85.5 ± 23.0 seconds vs. 94.2 ± 23.0 seconds for senior versus junior surgeons ( P  = 0.120).,['Methods\n\n\nSeventy patients'],"['intravitreal injection assistant device (InVitria', 'Intravitreal Injection with a Conjunctival Injection Device', 'intravitreal injections via the conventional freehand technique while 70 received injections using the InVitria']","['Mean injections times', 'pain scores regardless of technique', 'Mean injection times']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",70.0,0.0245215,Mean injection times with the conventional technique were 85.5 ± 23.0 seconds vs. 94.2 ± 23.0 seconds for senior versus junior surgeons ( P  = 0.120).,"[{'ForeName': 'Yu Qiang', 'Initials': 'YQ', 'LastName': 'Soh', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Nathalie Pei Yu', 'Initials': 'NPY', 'LastName': 'Chiam', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Andrew Shih Hsiang', 'Initials': 'ASH', 'LastName': 'Tsai', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Gemmy Chui Ming', 'Initials': 'GCM', 'LastName': 'Cheung', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Tien Yin', 'Initials': 'TY', 'LastName': 'Wong', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Ian Yew San', 'Initials': 'IYS', 'LastName': 'Yeo', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Edmund Yick Mun', 'Initials': 'EYM', 'LastName': 'Wong', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Anna Cheng Sim', 'Initials': 'ACS', 'LastName': 'Tan', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}]",Translational vision science & technology,['10.1167/tvst.9.8.28']
2732,32855881,Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision.,"Purpose


Patients with acquired monocular vision (AMV) lose vision in the temporal crescent on the side of the blind eye. This visual field loss affects patients' ability to detect potential hazards in the blind field. Mounting a base-in multiplexing prism (MxP) on the nasal side of the seeing eye can provide true field expansion and enable detection of potential collision hazards. We evaluated the efficacy of the MxP glasses in a virtual reality walking environment.
Methods


A three-dimensional printed clip-on MxP holder that can be adjusted for an individual user's facial parameters was developed. Virtual reality walking scenarios were designed to evaluate the effect of MxP field expansion on the detection of a pedestrian approaching from different initial bearing angles and courses. The pedestrian detection rates and response times of 10 participants with simulated AMV (normally sighted participants with one eye patched) and three patients with AMV were measured.
Results


The MxP provided true field expansion of about 25°. Participants performed significantly better with the MxP than without the MxP in the pedestrian detection task on their blind field, while their seeing field performance was not significantly different.
Conclusions


The MxP glasses for patients with AMV improved the detection of potential collision hazards in the blind field.
Translational Relevance


The MxP with an adjustable clip-on holder may help patients with AMV to decrease the risk of collision with other pedestrians.",2020,"Participants performed significantly better with the MxP than without the MxP in the pedestrian detection task on their blind field, while their seeing field performance was not significantly different.
","['10 participants with simulated AMV (normally sighted participants with one eye patched) and three patients with AMV were measured', 'Patients with acquired monocular vision (AMV']",['Multiplexing Prism'],['detection of potential collision hazards'],"[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0042797', 'cui_str': 'Monocular vision'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",[],"[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",10.0,0.0649163,"Participants performed significantly better with the MxP than without the MxP in the pedestrian detection task on their blind field, while their seeing field performance was not significantly different.
","[{'ForeName': 'Jae-Hyun', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Castle', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nish Mohith', 'Initials': 'NM', 'LastName': 'Kurukuti', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sailaja', 'Initials': 'S', 'LastName': 'Manda', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Peli', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}]",Translational vision science & technology,['10.1167/tvst.9.8.35']
2733,32855916,Evaluation of Nasopharyngeal Airway to Facilitate Nasotracheal Intubation.,"Background and Aims


Nasotracheal intubation is the most common method of airway management in oral and maxillofacial surgery patients. However, many times, it is associated with bleeding resulting from trauma to nasopharyngeal mucosa. We conducted this study to determine the effectiveness of nasopharyngeal airway (NPA) to easily facilitate the nasopharyngeal insertion and to reduce the trauma during nasotracheal intubation.
Methods


A total of 120 patients scheduled for elective oral and maxillofacial surgery requiring nasotracheal intubation were randomly divided into two groups of 60 each, after preparation with xylometazoline drops intranasally, lubrication with lignocaine jelly, and thermosoftening of the tip of the endotracheal tube (ETT). In group NPA, dilatation of the nasal cavity was done with NPA before nasotracheal intubation and in Group C, nasotracheal intubation was done without dilatation of the nasal cavity. The smoothness of insertion of ETT was graded on a 4‑point rating scale. Assessment of bleeding into nasopharynx was confirmed during laryngoscopy and was also graded with 4‑point scale.
Results


In the NPA group, all the 60 (100%) patients had smooth or relatively smooth (Grade 0 or 1) insertion compared to 51 (85%) patients in the control group ( P  < 0.0001). Eighteen (30%) patients had mild (Grade 1) bleeding and one (1.67%) patient had moderate bleeding (Grade 2) in the control group, whereas only four (6.67%) patients in the NPA group had mild (Grade 1) bleeding ( P  = 0.0005).
Conclusion


Dilatation of nasal cavity with NPA significantly eases the insertion of ETT into the nasopharynx and also significantly decreases the incidence and severity of trauma and bleeding during nasotracheal intubation.",2020,"A total of 120 patients scheduled for elective oral and maxillofacial surgery requiring nasotracheal intubation were randomly divided into two groups of 60 each, after preparation with xylometazoline drops intranasally, lubrication with lignocaine jelly, and thermosoftening of the tip of the endotracheal tube (ETT).","['oral and maxillofacial surgery patients', '120 patients scheduled for elective oral and maxillofacial surgery requiring nasotracheal intubation']","['xylometazoline drops intranasally, lubrication with lignocaine jelly, and thermosoftening of the tip of the endotracheal tube (ETT', 'nasopharyngeal airway (NPA']","['mild (Grade 1) bleeding', 'moderate bleeding', 'incidence and severity of trauma and bleeding', 'smooth or relatively smooth (Grade 0 or 1) insertion', 'bleeding into nasopharynx']","[{'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}]","[{'cui': 'C0078643', 'cui_str': 'xylometazoline'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0150683', 'cui_str': 'Nasopharyngeal airway device'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}]",120.0,0.0682323,"A total of 120 patients scheduled for elective oral and maxillofacial surgery requiring nasotracheal intubation were randomly divided into two groups of 60 each, after preparation with xylometazoline drops intranasally, lubrication with lignocaine jelly, and thermosoftening of the tip of the endotracheal tube (ETT).","[{'ForeName': 'Vinay R', 'Initials': 'VR', 'LastName': 'Dhakate', 'Affiliation': 'Department of Anaesthesia, Jawaharlal Nehru Medical College, Wardha, Maharashtra, India.'}, {'ForeName': 'Amol Prakash', 'Initials': 'AP', 'LastName': 'Singam', 'Affiliation': 'Department of Anaesthesia, Jawaharlal Nehru Medical College, Wardha, Maharashtra, India.'}, {'ForeName': 'Harshvardhan S', 'Initials': 'HS', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Anaesthesia, Jawaharlal Nehru Medical College, Wardha, Maharashtra, India.'}]",Annals of maxillofacial surgery,['10.4103/ams.ams_190_19']
2734,32855917,Efficacy of Various Routes of Dexamethasone Administration in Reducing Postoperative Sequelae Following Impacted Third Molar Surgery.,"Aim


To compare the efficacy of intravenous (IV), intramassetric (IM) submucosal (SM) routes & oral routes of dexamethasone administration post impacted third molar removal surgery.
Type of Study


Prospective randomized comparative clinical study.
Materials and Method


This prospective comparative study included 60 patients with Class II and position B type of impaction (according to Pell and Gregory's classification). Patients were randomly divided into 4 groups. Group A, B, C & D patients received 8mg dexamethasone immediately post-surgical tooth removal via the IV, SM and IM route & oral respectively. Assessment of swelling, mouth opening and pain was done at intervals of 1st, 3rd and 7th post-op days.
Results


The average age of the patients was 27 years. The mean time taken was 20 mins 40 seconds. The IV group showed minimal swelling and better pain control on the 3rd post op day (statistically significant). All 4 routes showed comparable mouth opening results.
Conclusion


IV administration of dexamethasone post third molar surgery has been the traditional way because of its faster onset of action and increased efficacy; IM and SM routes are also comparably effective although oral route had the best patient acceptance.",2020,The IV group showed minimal swelling and better pain control on the 3rd post op day (statistically significant).,"['Following Impacted Third Molar Surgery', ""60 patients with Class II and position B type of impaction (according to Pell and Gregory's classification""]","['intravenous (IV), intramassetric (IM) submucosal (SM', 'dexamethasone', 'Dexamethasone']","['Postoperative Sequelae', 'Assessment of swelling, mouth opening and pain', 'minimal swelling and better pain control', 'mean time taken']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",60.0,0.0323033,The IV group showed minimal swelling and better pain control on the 3rd post op day (statistically significant).,"[{'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Vivek', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Rajiv Gandhi College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vaibhav', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Rajiv Gandhi College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Shetty', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Rajiv Gandhi College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammad', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Rajiv Gandhi College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Rajiv Gandhi College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Hemavathi', 'Initials': 'H', 'LastName': 'Umeshappa', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Rajiv Gandhi College of Dental Sciences, Bengaluru, Karnataka, India.'}]",Annals of maxillofacial surgery,['10.4103/ams.ams_66_19']
2735,32855921,Do Patients have the Same Experience of Pain Following Tooth Extraction and Dental Implants?,"Introduction


Postoperative pain is an important concern for patients who need dental implants. This study aims to compare the experience of pain in patients who undergo tooth removal and dental implant surgery.
Materials and Methods


This is a crossover study. Patients who underwent a simple tooth extraction and dental implant surgery were studied. The pain severity was assessed using a visual analog scale at 12, 24, 48, and 72 h after procedures. The repeated measure test was used to compare pain severity between two treatment sessions.
Results


Forty patients were studied. Patients reported higher pain levels in a tooth extraction at study times than implant surgery ( P  = 0.001).
Conclusion


It seems patients who had experience of tooth extraction and a dental implant placement reported significantly lower pain in implant surgery.",2020,"Patients reported higher pain levels in a tooth extraction at study times than implant surgery ( P  = 0.001).
","['patients who undergo tooth removal and dental implant surgery', 'patients who need dental implants', 'Patients who underwent a simple tooth extraction and dental implant surgery were studied']",[],"['pain severity', 'pain levels', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",40.0,0.0681606,"Patients reported higher pain levels in a tooth extraction at study times than implant surgery ( P  = 0.001).
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tabrizi', 'Affiliation': 'Associate Professor of Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mohajerani', 'Affiliation': 'Professor of Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atieh', 'Initials': 'A', 'LastName': 'Nabtieh', 'Affiliation': 'Dentistry student, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Shafiei', 'Affiliation': 'Resident of Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Annals of maxillofacial surgery,['10.4103/ams.ams_281_19']
2736,32855924,Platelet-Rich Fibrin for Hard- and Soft-Tissue Healing in Mandibular Third Molar Extraction Socket.,"Background


Successful management of patients reporting with extreme sensitivity in second molar after surgical extraction of deeply impacted mandibular third molar poses a big challenge to oral surgeons and periodontists worldwide. A variety of grafts, barrier membranes, and guided tissue regeneration techniques have been used postsurgically for soft- and hard-tissue formation. In the current study, platelet-rich fibrin (PRF), a second-generation platelet aggregate, was assessed for its effectiveness in promoting hard- and soft-tissue healing.
Objective


The aim of the study was to evaluate the efficacy of PRF in hard- and soft-tissue healing after extraction of mandibular third molar.
Materials and Methods


Bilateral surgical disimpaction of mandibular third molar was done on 25 patients. In every patient, randomly allocated test side received PRF and the other side acted as control. Pain, edema, tenderness, sensitivity, Sulcus Bleeding Index (SBI), Plaque Index, clinical attachment level (CAL), probing depth, and bone height were measured at different intervals for a maximum period of 6 months.
Results


There was a statistically significant improvement in patients' signs and symptoms of pain, tenderness, edema, and sensitivity with the use of PRF. A statistically significant improvement was seen in SBI, Plaque Index, and probing depths, while CALs and bone height were not influenced by PRF use.
Conclusion


PRF is a very viable and useful biomaterial for soft-tissue healing and relieving patient symptoms, however, it does not help in hard-tissue healing with respect to cortical bone.",2020,"A statistically significant improvement was seen in SBI, Plaque Index, and probing depths, while CALs and bone height were not influenced by PRF use.
","['patients reporting with extreme sensitivity in second molar after surgical extraction of deeply impacted mandibular third molar', '25 patients']","['Platelet-Rich Fibrin', 'PRF', 'platelet-rich fibrin (PRF']","['SBI, Plaque Index, and probing depths, while CALs and bone height', 'Pain, edema, tenderness, sensitivity, Sulcus Bleeding Index (SBI), Plaque Index, clinical attachment level (CAL), probing depth, and bone height', ""patients' signs and symptoms of pain, tenderness, edema, and sensitivity with the use of PRF""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C4554317', 'cui_str': 'Deeply'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}]",25.0,0.0521915,"A statistically significant improvement was seen in SBI, Plaque Index, and probing depths, while CALs and bone height were not influenced by PRF use.
","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Sybil', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Jamia Millia Islamia, New Delhi, India.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Sawai', 'Affiliation': 'Department of Periodontics, Jamia Millia Islamia, New Delhi, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faisal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Jamia Millia Islamia, New Delhi, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Jamia Millia Islamia, New Delhi, India.'}, {'ForeName': 'Vanshika', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India.'}]",Annals of maxillofacial surgery,['10.4103/ams.ams_228_19']
2737,32855925,Role of Serratiopeptidase and Dexamethasone in the Control of Postoperative Swelling.,"Aim


The present study is designed to evaluate and compare the ability of serratiopeptidase and dexamethasone to control edema following the surgical removal of mandibular third molar.
Materials and Methods


Two drugs, dexamethasone and serratiopeptidase, were compared for its efficacy in reducing the postoperative swelling. A total of 100 patients requiring the surgical removal of impacted mandibular third molar were randomly divided into two groups, consisting of 50 patients each. One group was administered 1 mg dexamethasone, one-half h preoperatively and every 8 th  hourly for 3 days postoperatively. The other group was given 10 mg serratiopeptidase every 8 th  hourly for 3 days postoperatively. The swelling was measured on 1 st , 2 nd , 5 th , and 7 th  postoperative days. The results of this study showed that serratiopeptidase was effective in reducing swelling from 2 nd  to 5 th  postoperative day, and dexamethasone was effective in reducing swelling from 1 st  to 2 nd  postoperative day, further, it also reduced the swelling from 2 nd  to 5 th  postoperative day.
Results


There was highly significant difference in the facial measurement between serratiopeptidase and dexamethasone group on postoperative day 2 (the mean difference was 62.5 with  P  < 0.001) and statistically significant difference on postoperative day 1, day 5, and day 7 ( P  < 0.01).
Conclusion


It can be concluded that serratiopeptidase, a proteolytic enzyme and dexamethasone, a long-acting corticosteroid was effective in reducing the swelling, but dexamethasone was more effective than serratiopeptidase in reducing the swelling.",2020,"The results of this study showed that serratiopeptidase was effective in reducing swelling from 2 nd  to 5 th  postoperative day, and dexamethasone was effective in reducing swelling from 1 st  to 2 nd  postoperative day, further, it also reduced the swelling from 2 nd  to 5 th  postoperative day.
",['100 patients requiring the surgical removal of impacted mandibular third molar'],"['Serratiopeptidase and Dexamethasone', 'dexamethasone', 'serratiopeptidase and dexamethasone']","['swelling', 'facial measurement']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0074389', 'cui_str': 'serratiopeptidase'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",100.0,0.0477073,"The results of this study showed that serratiopeptidase was effective in reducing swelling from 2 nd  to 5 th  postoperative day, and dexamethasone was effective in reducing swelling from 1 st  to 2 nd  postoperative day, further, it also reduced the swelling from 2 nd  to 5 th  postoperative day.
","[{'ForeName': 'B Pramod', 'Initials': 'BP', 'LastName': 'Krishna', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Chhattisgarh Dental College and Research Institute, Rajnandgaon, Chhattisgarh, India.'}, {'ForeName': 'B Praveen', 'Initials': 'BP', 'LastName': 'Reddy', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dental College, Regional Institute of Medical Sciences, Imphal, Manipur, India.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Yashavanth Kumar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dental Sciences, Davangere, Karnataka, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ummar', 'Affiliation': 'Department of OMFS, MES Dental College, Perinthalmanna, Kerala, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Shekhar', 'Affiliation': 'PHC, Patna, Bihar, India.'}, {'ForeName': 'Rahul Vinay', 'Initials': 'RV', 'LastName': 'Chandra Tiwari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Sai College of Dental Surgery, Vikarabad, Telangana, India.'}]",Annals of maxillofacial surgery,['10.4103/ams.ams_249_19']
2738,32852904,Mepivacaine versus Bupivacaine Spinal Anesthesia for Early Postoperative Ambulation: A Randomized Controlled Trial.,"BACKGROUND


Early ambulation after total hip arthroplasty predicts early discharge. Spinal anesthesia is preferred by many practices but can delay ambulation, especially with bupivacaine. Mepivacaine, an intermediate-acting local anesthetic, could enable earlier ambulation than bupivacaine. This study was designed to test the hypothesis that patients who received mepivacaine would ambulate earlier than those who received hyperbaric or isobaric bupivacaine for primary total hip arthroplasty.
METHODS


This randomized controlled trial included American Society of Anesthesiologists Physical Status I to III patients undergoing primary total hip arthroplasty. The patients were randomized 1:1:1 to 52.5 mg of mepivacaine, 11.25 mg of hyperbaric bupivacaine, or 12.5 mg of isobaric bupivacaine for spinal anesthesia. The primary outcome was ambulation between 3 and 3.5 h. Secondary outcomes included return of motor and sensory function, postoperative pain, opioid consumption, transient neurologic symptoms, urinary retention, intraoperative hypotension, intraoperative muscle tension, same-day discharge, length of stay, and 30-day readmissions.
RESULTS


Of 154 patients, 50 received mepivacaine, 53 received hyperbaric bupivacaine, and 51 received isobaric bupivacaine. Patient characteristics were similar among groups. For ambulation at 3 to 3.5 h, 35 of 50 (70.0%) of patients met this endpoint in the mepivacaine group, followed by 20 of 53 (37.7%) in the hyperbaric bupivacaine group, and 9 of 51 (17.6%) in the isobaric bupivacaine group (P < 0.001). Return of motor function occurred earlier with mepivacaine. Pain and opioid consumption were higher for mepivacaine patients in the early postoperative period only. For ambulatory status, 23 of 50 (46.0%) of mepivacaine, 13 of 53 (24.5%) of hyperbaric bupivacaine, and 11 of 51 (21.5%) of isobaric bupivacaine patients had same-day discharge (P = 0.014). Length of stay was shortest in mepivacaine patients. There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
CONCLUSIONS


Mepivacaine patients ambulated earlier and were more likely to be discharged the same day than both hyperbaric bupivacaine and isobaric bupivacaine patients. Mepivacaine could be beneficial for outpatient total hip arthroplasty candidates if spinal is the preferred anesthesia type. : WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Early ambulation after total hip arthroplasty is key to achieving readiness for dischargeThe spinal anesthetic for total hip arthroplasty that balances pain control with timely resolution of motor block has not been identified WHAT THIS ARTICLE TELLS US THAT IS NEW: In this randomized, three-arm study involving 154 patients, more individuals in the mepivacaine spinal group ambulated 3 to 3.5 h after injection than did individuals in either the isobaric or hyperbaric bupivacaine groupLikewise, more patients in the mepivacaine group achieved same-day discharge than patients in the other experimental groups.",2020,"There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
","['154 patients, 50 received', 'American Society of Anesthesiologists Physical Status I to III patients undergoing primary total hip arthroplasty', 'Early Postoperative Ambulation', 'for primary total hip arthroplasty', '154 patients, more individuals in the mepivacaine spinal group ambulated 3 to 3.5 h after injection than did individuals in either the']","['bupivacaine', 'mepivacaine, 11.25 mg of hyperbaric bupivacaine', 'isobaric bupivacaine', 'hyperbaric bupivacaine', 'Bupivacaine Spinal Anesthesia', 'isobaric or hyperbaric bupivacaine groupLikewise', 'mepivacaine', 'Mepivacaine', 'hyperbaric or isobaric bupivacaine']","['ambulation', 'return of motor and sensory function, postoperative pain, opioid consumption, transient neurologic symptoms, urinary retention, intraoperative hypotension, intraoperative muscle tension, same-day discharge, length of stay, and 30-day readmissions', 'transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness', 'same-day discharge', 'Length of stay', 'Pain and opioid consumption']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C4517532', 'cui_str': '11.25'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",154.0,0.121315,"There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Schwenk', 'Affiliation': 'From the Department of Anesthesiology, Sidney Kimmel Medical College (E.S.S., J.D.S., M.S.A., S.A.B., W.J.H., A.J.C., J.J.L., C.S.W., J.L.B., M.C.T.) the Department of Physical Therapy (A.C.N.) Thomas Jefferson University (A.M.M.), Philadelphia, Pennsylvania United Anesthesia Services, Plymouth Meeting, Pennsylvania (V.P.K.) Rothman Orthopaedics, Philadelphia, Pennsylvania (M.S.A., S.A.B., W.J.H.) the Department of Physical Therapy, Rothman Orthopedic Specialty Hospital, Bensalem, Pennsylvania (E.E.C.).'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Kasper', 'Affiliation': ''}, {'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Smoker', 'Affiliation': ''}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Mendelson', 'Affiliation': ''}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Austin', 'Affiliation': ''}, {'ForeName': 'Scot A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hozack', 'Affiliation': ''}, {'ForeName': 'Alexa J', 'Initials': 'AJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Wahal', 'Affiliation': ''}, {'ForeName': 'Jaime L', 'Initials': 'JL', 'LastName': 'Baratta', 'Affiliation': ''}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Torjman', 'Affiliation': ''}, {'ForeName': 'Alyson C', 'Initials': 'AC', 'LastName': 'Nemeth', 'Affiliation': ''}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Czerwinski', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003480']
2739,32840074,[Research on the effect of background music on spatial cognitive working memory based on cortical brain network].,"Background music has been increasingly affecting people's lives. The research on the influence of background music on working memory has become a hot topic in brain science. In this paper, an improved electroencephalography (EEG) experiment based on n-back paradigm was designed. Fifteen university students without musical training were randomly selected to participate in the experiment, and their behavioral data and the EEG data were collected synchronously in order to explore the influence of different types of background music on spatial positioning cognition working memory. The exact low-resolution brain tomography algorithm (eLORETA) was applied to localize the EEG sources and the cross-correlation method was used to construct the cortical brain function networks based on the EEG source signals. Then the characteristics of the networks under different conditions were analyzed and compared to study the effects of background music on people's working memory. The results showed that the difference of peak periods after stimulated by different types of background music were mainly distributed in the signals of occipital lobe and temporal lobe (  P  < 0.05). The analysis results showed that the brain connectivity under the condition with background music were stronger than those under the condition without music. The connectivities in the right occipital and temporal lobes under the condition of rock music were significantly higher than those under the condition of classical music. The node degrees, the betweenness centrality and the clustering coefficients under the condition without music were lower than those under the condition with background music. The node degrees and clustering coefficients under the condition of classical music were lower than those under the condition of rock music. It indicates that music stimulation increases the brain activity and has an impact on the working memory, and the effect of rock music is more remarkable than that of classical music. The behavioral data showed that the response accuracy in the state of no music, classical music and rock music were 86.09% ± 0.090%, 80.96% ± 0.960% and 79.36% ± 0.360%, respectively. We conclude that background music has a negative impact on the working memory, for it takes up the cognitive resources and reduces the cognitive ability of spatial location.",2020,"The node degrees, the betweenness centrality and the clustering coefficients under the condition without music were lower than those under the condition with background music.",['Fifteen university students without musical training'],['background music'],['brain activity'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}]",,0.0454435,"The node degrees, the betweenness centrality and the clustering coefficients under the condition without music were lower than those under the condition with background music.","[{'ForeName': 'Shuaishuai', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Bioelectromagnetic Technology and Intelligent Health, Hebei University of Technology, Tianjin 300130, P.R.China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Bioelectromagnetic Technology and Intelligent Health, Hebei University of Technology, Tianjin 300130, P.R.China;State Key Laboratory of Reliability and Intelligence of Electrical Equipment, Hebei University of Technology, Tianjin 300130, P.R.China.'}, {'ForeName': 'Jipeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Bioelectromagnetic Technology and Intelligent Health, Hebei University of Technology, Tianjin 300130, P.R.China.'}, {'ForeName': 'Lingyue', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Bioelectromagnetic Technology and Intelligent Health, Hebei University of Technology, Tianjin 300130, P.R.China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Yin', 'Affiliation': 'Tianjin Key Laboratory of Bioelectromagnetic Technology and Intelligent Health, Hebei University of Technology, Tianjin 300130, P.R.China;State Key Laboratory of Reliability and Intelligence of Electrical Equipment, Hebei University of Technology, Tianjin 300130, P.R.China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Tianjin Key Laboratory of Bioelectromagnetic Technology and Intelligent Health, Hebei University of Technology, Tianjin 300130, P.R.China;State Key Laboratory of Reliability and Intelligence of Electrical Equipment, Hebei University of Technology, Tianjin 300130, P.R.China.'}]",Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi,['10.7507/1001-5515.201907065']
2740,32845715,Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure with Preserved Ejection Fraction.,"Background:  In patients with heart failure, chronic kidney disease (CKD) is common and associated with a higher risk of renal events than in patients without CKD. We assessed the renal effects of angiotensin/neprilysin inhibition in patients with heart failure and preserved ejection fraction (HFpEF) enrolled in PARAGON-HF.  Methods:  In this randomized, double-blind, event-driven trial, we assigned 4,822 patients with HFpEF to receive sacubitril/valsartan (n=2419) or valsartan (n=2403). Herein we present the results of the pre-specified renal composite outcome (time to first occurrence of either: ≥50% reduction in eGFR, end-stage renal disease, or death from renal causes), the individual components of this composite, and the influence of therapy on eGFR slope.  Results:  At randomization, eGFR was 63±19 ml/min/1.73m 2 . At study closure, the composite renal outcome occurred in 33 patients (1.4%) assigned to sacubitril/valsartan and 64 patients (2.7%) assigned to valsartan (hazard ratio [HR], 0.50; 95%CI, 0.33 to 0.77; P=0.001). The treatment effect on the composite renal endpoint did not differ according to the baseline eGFR (<60 vs ≥ 60 ml/min/1.73 m 2  (P-interaction=0.92). The decline in eGFR was less for sacubitril/valsartan compared with valsartan (-1.8 [95%CI, -2.0 to -1.6] vs. -2.4 [95%CI, -2.6 to - 2.2] ml/min/1.73m 2 /year).  Conclusions:  In patients with HFpEF, sacubitril/valsartan reduced the risk of renal events, and slowed decline in eGFR, compared with valsartan.  Clinical Trial Registration:  URL: https://clinicaltrials.gov/ Unique Identifier: NCT01920711.",2020,The treatment effect on the composite renal endpoint did not differ according to the baseline eGFR (<60 vs ≥ 60 ml/min/1.73 m 2  (P-interaction=0.92).,"['patients with heart failure and preserved ejection fraction (HFpEF) enrolled in PARAGON-HF', 'patients with heart failure, chronic kidney disease (CKD', '4,822 patients with HFpEF to receive', 'Heart Failure with Preserved Ejection Fraction', 'n=2403']","['angiotensin/neprilysin inhibition', 'URL', 'valsartan', 'sacubitril/valsartan (n=2419) or valsartan']","['decline in eGFR', 'Angiotensin-Neprilysin Inhibition and Renal Outcomes', 'eGFR, end-stage renal disease, or death from renal causes', 'risk of renal events', 'composite renal endpoint', 'composite renal outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0616412', 'cui_str': 'paragon'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]","[{'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",4822.0,0.239173,The treatment effect on the composite renal endpoint did not differ according to the baseline eGFR (<60 vs ≥ 60 ml/min/1.73 m 2  (P-interaction=0.92).,"[{'ForeName': 'Finnian R', 'Initials': 'FR', 'LastName': 'Mc Causland', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA.""}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Harvard Medical School, Boston, MA; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Nagesh S', 'Initials': 'NS', 'LastName': 'Anavekar', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Azienda Ospedaliera Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Azienda Ospedaliera Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Martina M', 'Initials': 'MM', 'LastName': 'McGrath', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Inserm CIC1433, CHRU de Nancy, France; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': ""Department of Cardiology, Bellvitge University Hospital and Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Clinical Sciences, School of Medicine, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Harvard Medical School, Boston, MA; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Harvard Medical School, Boston, MA; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}]",Circulation,['10.1161/CIRCULATIONAHA.120.047643']
2741,32845997,A Randomized Controlled Trial of Intravenous N-acetylcysteine in the Management of Anti-tuberculosis Drug-Induced Liver Injury.,"BACKGROUND


Liver injury is a common complication of first-line anti-tuberculosis therapy. N-acetylcysteine (NAC) is widely used in patients with paracetamol toxicity with limited evidence of benefit in liver injury due to other causes.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial to assess whether intravenous NAC hastens liver recovery in hospitalized adult patients with anti-tuberculosis drug induced liver injury (AT-DILI). The primary endpoint was the time for serum alanine aminotransferase (ALT) to fall below 100 U/L. Secondary endpoints included length of hospital stay, in-hospital mortality and adverse events.
RESULTS


Fifty-three participants were randomized to NAC and 49 to placebo. Mean age was 38 (SD±10) years, 58 (57%) were female and 89 (87%) were HIV-positive. Median serum ALT and total bilirubin at presentation were 462 U/L (IQR 266-790) and 56 μmol/L (IQR 25-100) respectively. Median time to ALT&100 U/L was 7.5 days (IQR 6 -11) in the NAC arm and 8 days (IQR 5 -13) in the placebo arm. Median time to hospital discharge was shorter in the NAC arm (9 days; IQR 6-15) than in the placebo arm (18 days; IQR 10-25), hazard ratio 1.73 (95% CI 1.13-2.65). Mortality was 14% overall and did not differ by study arm. The study infusion was stopped early due to an adverse reaction in 5 participants receiving NAC [nausea and vomiting (3), anaphylaxis (1), pain at drip site (1)].
CONCLUSION


NAC did not shorten time to ALT&100 U/L in participants with AT-DILI, but significantly reduced length of hospital stay. NAC should be considered in management of AT-DILI.",2020,NAC did not shorten time to ALT&100,"['5 participants receiving NAC [nausea and vomiting (3), anaphylaxis (1), pain at drip site (1', 'Fifty-three participants', 'hospitalized adult patients with anti-tuberculosis drug induced liver injury (AT-DILI', 'Mean age was 38 (SD±10) years, 58 (57%) were female and 89 (87%) were HIV-positive', 'Anti-tuberculosis Drug-Induced Liver Injury']","['intravenous NAC', 'ALT&100', 'placebo', 'NAC', 'Intravenous N-acetylcysteine', 'N-acetylcysteine (NAC']","['Mortality', 'length of hospital stay, in-hospital mortality and adverse events', 'Median serum ALT and total bilirubin', 'time for serum alanine aminotransferase (ALT', 'Median time to hospital discharge', 'length of hospital stay', 'Median time to ALT&100']","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0860207', 'cui_str': 'Drug-induced disorder of liver'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",53.0,0.726472,NAC did not shorten time to ALT&100,"[{'ForeName': 'Muhammed S', 'Initials': 'MS', 'LastName': 'Moosa', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Gunter', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shaazia', 'Initials': 'S', 'LastName': 'Allie', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Chughlay', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mashiko', 'Initials': 'M', 'LastName': 'Setshedi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Wasserman', 'Affiliation': 'Division of Infectious Diseases and HIV Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hickman', 'Affiliation': 'Clinical Research Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Annemie', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Clinical Research Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sonderup', 'Affiliation': 'Division of Hepatology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Catherine Wendy', 'Initials': 'CW', 'LastName': 'Spearman', 'Affiliation': 'Division of Hepatology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cohen', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1255']
2742,32846062,A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.,"BACKGROUND


A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.
METHODS


In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.
RESULTS


A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
CONCLUSIONS


In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).",2020,"No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
","['children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump', 'children with type 1 diabetes', 'children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a', 'Children with Type 1 Diabetes', '101 children']","['Closed-Loop Control', 'closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group']","['median percentage of time that the system', 'diabetic ketoacidosis or severe hypoglycemia', 'median percentage of time that the glucose level', 'glycated hemoglobin levels', 'glycemic outcomes', 'mean (±SD) percentage of time that the glucose level', 'percentage of time that the glucose level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",101.0,0.0869124,"No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
","[{'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Schoelwer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Ruedy', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Jost', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Carria', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Emory', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Liana J', 'Initials': 'LJ', 'LastName': 'Hsu', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Oliveri', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Kollman', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Betsy B', 'Initials': 'BB', 'LastName': 'Dokken', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cherñavvsky', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004736']
2743,32846108,Efficacy of a bolus calculator and advanced carbohydrate counting in type 2 diabetes: A randomized clinical trial.,"BACKGROUND


Carbohydrate counting and use of automated bolus calculators (ABCs) can help reduce HbA1c in type 1 diabetes but only limited evidence exists in type 2 diabetes. We evaluated the efficacy of advanced carbohydrate counting (ACC) and use of an ABC compared with manual insulin bolus calculation (MC) in persons with type 2 diabetes.
MATERIALS AND METHODS


A 24-week open-label, randomised clinical study was conducted in 79 persons with type 2 diabetes treated with basal-bolus insulin (mean age 62.5±9.6 years, HbA1c 8.7±1.0% (72±11 mmol/mol), diabetes duration 18.7±7.6 years). Participants were randomised 1:1 into two groups: ABC group received training in ACC and use of an ABC; MC group received training in ACC and manual calculation of insulin bolus. Participants wore blinded continuous glucose monitors (CGM) for six days at baseline and at study end. Primary endpoint was change in HbA1c.
RESULTS


After 24 weeks HbA1c decreased 0.8% (8.8 mmol/mol) in ABC group and 0.8% (9.0 mmol/mol) in MC group with no between-group difference (P=0.96) and without increase in time in hypoglycaemic range (Sensor glucose (SG)<3.9 mmol/L). Glycaemic variability decreased significantly in both groups whereas the total insulin dose and BMI remained unchanged during the study. Treatment satisfaction increased significantly in both groups after 24 weeks.
CONCLUSION


ACC is an effective, low-cost tool to reduce HbA1c and glycaemic variability in persons with basal-bolus insulin treated type 2 diabetes without increase in hypoglycaemia or BMI. Similar effects were seen with use of an ABC and with use of manual bolus calculation.",2020,"ACC is an effective, low-cost tool to reduce HbA1c and glycaemic variability in persons with basal-bolus insulin treated type 2 diabetes without increase in hypoglycaemia or BMI.","['type 2 diabetes', '79 persons with type 2 diabetes treated with basal-bolus insulin (mean age 62.5±9.6 years, HbA1c 8.7±1.0% (72±11 mmol/mol), diabetes duration 18.7±7.6 years', 'persons with type 2 diabetes']","['manual insulin bolus calculation (MC', 'ABC group received training in ACC and use of an ABC; MC group received training in ACC and manual calculation of insulin bolus', 'ACC', 'blinded continuous glucose monitors (CGM', 'bolus calculator and advanced carbohydrate counting', 'advanced carbohydrate counting (ACC', 'Carbohydrate counting and use of automated bolus calculators (ABCs']","['hypoglycaemia or BMI', 'Glycaemic variability', 'HbA1c and glycaemic variability', 'time in hypoglycaemic range', 'change in HbA1c', 'Treatment satisfaction', 'total insulin dose and BMI']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",79.0,0.0586546,"ACC is an effective, low-cost tool to reduce HbA1c and glycaemic variability in persons with basal-bolus insulin treated type 2 diabetes without increase in hypoglycaemia or BMI.","[{'ForeName': 'Merete Bechmann', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Hvidovre Hospital, 53137, Kettegards Alle 30, Hvidovre, Denmark, 2650.'}, {'ForeName': 'Nermin', 'Initials': 'N', 'LastName': 'Serifovski', 'Affiliation': 'Hvidovre Hospital, 53137, Hvidovre, Denmark.'}, {'ForeName': 'Anne Marie Holm', 'Initials': 'AMH', 'LastName': 'Herz', 'Affiliation': 'Hvidovre Hospital, 53137, Hvidovre, Denmark; amhherz@gmail.com.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Hvidovre Hospital, 53137, Endocrinology, Hvidovre, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hommel', 'Affiliation': 'Steno Diabetes Center Copenhagen, 53138, Gentofte, Denmark; eva.hommel@regionh.dk.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Raimond', 'Affiliation': 'Steno Diabetes Center Copenhagen, 53138, Gentofte, Denmark; linda.raimond@regionh.dk.'}, {'ForeName': 'Hans Jørgen Duckert', 'Initials': 'HJD', 'LastName': 'Perrild', 'Affiliation': 'Bispebjerg Hospital, 53166, Department of Internal Medicine, København, Denmark; hans.joergen.duckert.perrild@regionh.dk.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gotfredsen', 'Affiliation': 'Hvidovre Hospital, 53137, Hvidovre, Denmark; anders.gotfredsen@regionh.dk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gaede', 'Affiliation': 'Slagelse Hospital, 73014, Slagelse, Denmark; phgo@regionsjaelland.dk.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, 53138, Gentofte, Denmark.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0276']
2744,32852967,Effects of patient-therapist interpersonal complementarity on alliance and outcome in cognitive-behavioral therapies for depression: Moving toward interpersonal responsiveness.,"This study analyzed patient-therapist in-session interpersonal complementarity effects on the therapeutic alliance and depression severity during the initial and working phase of cognitive-behavioral therapy for depression. It also explored whether patients' interpersonal problems moderate those complementarity effects. We drew on a sample of 90 dyads derived from a randomized controlled trial of two cognitive-behavioral therapies for depression. Using an observer-based measure, we assessed patients' and therapists' interpersonal behavior in Sessions 1, 5, 9, and 13 and computed their complementarity regarding interpersonal affiliation (i.e., correspondence) and dominance (i.e., reciprocity). Patients completed measures of interpersonal problems at baseline and session-by-session measures of depression severity and quality of the therapeutic alliance. Response surface analyses based on polynomial regressions showed that patient-therapist complementarity in higher affiliative behaviors was associated with a stronger alliance. Interpersonal problems regarding agency moderated the complementarity effects of the dominance dimensions on depression severity. Overly dominant patients benefited more from a nonreciprocal relationship in the dominance dimension, whereas submissive patients benefited more from complementarity in that dimension. Furthermore, interpersonal problems of communion significantly moderated the effects of complementarity in affiliative behaviors on both the alliance and outcome. These results suggest the relevance of both interpersonal correspondence and reciprocity for the psychotherapy process, informing clinical practice in terms of interpersonal responsiveness. The moderation effects of interpersonal problems provide preliminary evidence, which should be replicated in future research, to determine relevant markers indicating for whom a complementary approach would be beneficial in cognitive therapy for depression. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Response surface analyses based on polynomial regressions showed that patient-therapist complementarity in higher affiliative behaviors was associated with a stronger alliance.,[],"['patient-therapist interpersonal complementarity', 'cognitive-behavioral therapies']","['depression severity and quality of the therapeutic alliance', 'interpersonal problems', 'therapeutic alliance and depression severity', 'depression severity']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",90.0,0.0384272,Response surface analyses based on polynomial regressions showed that patient-therapist complementarity in higher affiliative behaviors was associated with a stronger alliance.,"[{'ForeName': 'Juan Martín', 'Initials': 'JM', 'LastName': 'Gómez Penedo', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rubel', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Clinical Psychology and Psychotherapy Department.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Alalú', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Anna Margarete', 'Initials': 'AM', 'LastName': 'Babl', 'Affiliation': 'Clinical Psychology and Psychotherapy Department.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Roussos', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Clinical Psychology and Psychotherapy Department.'}]",Journal of counseling psychology,['10.1037/cou0000528']
2745,32853015,Moderators of treatment efficacy in a randomized controlled trial of trauma-sensitive yoga as an adjunctive treatment for posttraumatic stress disorder.,"OBJECTIVE


This study is a follow-up to van der Kolk et al. (2014), a trial conducted through the Trauma Center at Justice Resource Institute, which demonstrated treatment efficacy and remains the only randomized controlled trial of trauma-sensitive yoga. The present process study extends the outcomes study by examining treatment moderators of the original trial.
METHOD


Sixty-four women with childhood interpersonal trauma histories and posttraumatic stress disorder participated in the interventions: Trauma Center Trauma-Sensitive Yoga (TCTSY) versus active control (women's health education). Analyses explored if adult-onset interpersonal trauma and baseline psychological measures (clinician-rated and self-reported PTSD, dissociation, depression, psychological functioning) moderated PTSD changes.
RESULTS


Three of six measures had small effects in moderating the relationship between adult-onset interpersonal trauma and TCTSY efficacy, in which TCTSY was most efficacious for those with fewer adult-onset interpersonal traumas. Within this subgroup, various levels of all baseline measures except depression indicated that TCTSY was more effective in reducing PTSD than the active control condition.
CONCLUSIONS


By delineating client characteristics most associated with PTSD improvements, practitioners may best target yoga interventions to increase effectiveness. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Within this subgroup, various levels of all baseline measures except depression indicated that TCTSY was more effective in reducing PTSD than the active control condition.
","['Sixty-four women with childhood interpersonal trauma histories and posttraumatic stress disorder participated in the', 'posttraumatic stress disorder']","['TCTSY', 'trauma-sensitive yoga', ""interventions: Trauma Center Trauma-Sensitive Yoga (TCTSY) versus active control (women's health education""]","['adult-onset interpersonal trauma and baseline psychological measures (clinician-rated and self-reported PTSD, dissociation, depression, psychological functioning) moderated PTSD changes']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",64.0,0.0918715,"Within this subgroup, various levels of all baseline measures except depression indicated that TCTSY was more effective in reducing PTSD than the active control condition.
","[{'ForeName': 'Viann N', 'Initials': 'VN', 'LastName': 'Nguyen-Feng', 'Affiliation': 'Department of Psychology, University of Minnesota, Duluth.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Hodgdon', 'Affiliation': 'Trauma Center at Justice Resource Institute.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Emerson', 'Affiliation': 'Center for Trauma and Embodiment at Justice Resource Institute.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Silverberg', 'Affiliation': 'College of Integrative Medicine and Health Sciences, Saybrook University.'}, {'ForeName': 'Cari Jo', 'Initials': 'CJ', 'LastName': 'Clark', 'Affiliation': 'Rollins School of Public Health, Emory University.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000963']
2746,32853116,Chronic effects of muscle and nerve-directed stretching on tissue mechanics.,"Tissue-directed stretching interventions can preferentially load muscular or non-muscular structures such as peripheral nerves. How these tissues adapt mechanically to long-term stretching is poorly understood. This randomized, single-blind, controlled study used ultrasonography and dynamometry to compare the effects of 12-week nerve-directed and muscle-directed stretching programs versus control on: maximal ankle dorsiflexion range of motion (ROM) and passive torque, shear wave velocity (SWV; an index of stiffness) and architecture of triceps surae and sciatic nerve. Sixty healthy adults were randomized to receive nerve-directed, muscle-directed stretching, or no intervention (control). The muscle-directed protocol was designed to primarily stretch the plantar flexor muscle group, while the nerve-directed intervention targeted the sciatic nerve tract. Compared with the control group (mean; 95% Confidence Interval), muscle-directed intervention showed increased ROM (+7.3°; 95% CI: 4.1-10.5), decreased SWV of triceps surae (varied from -0.8 to -2.3m/s across muscles), decreased passive torque (-6.8N.m; 95% CI: -11.9 to -1.7), and greater gastrocnemius medialis fascicle length (+0.4cm; 95% CI: 0.1 to 0.8). Muscle-directed intervention did not affect the SWV and size of sciatic nerve. Participants in nerve-directed group showed a significant increase in ROM (+9.9°; 95% CI: 6.2 to 13.6) and a significant decrease in sciatic nerve SWV (> -1.8m/s across nerve regions) compared with the control group. Nerve-directed intervention had no effect on the main outcomes at muscle and joint levels. These findings provide new insights into the long-term mechanical effects of stretching interventions, and have relevance to clinical conditions where change in mechanical properties has occurred.",2020,"Compared with the control group (mean; 95% Confidence Interval), muscle-directed intervention showed increased ROM (+7.3°; 95% CI: 4.1-10.5), decreased SWV of triceps surae (varied from -0.8 to -2.3m/s across muscles), decreased passive torque (-6.8N.m; 95% CI: -11.9 to -1.7), and greater gastrocnemius medialis fascicle length (+0.4cm; 95% CI: 0.1 to 0.8).",['Sixty healthy adults'],"['nerve-directed, muscle-directed stretching, or no intervention (control', '12-week nerve-directed and muscle-directed stretching programs', 'muscle and nerve-directed stretching', 'Tissue-directed stretching interventions']","['SWV of triceps surae', 'main outcomes at muscle and joint levels', 'gastrocnemius medialis fascicle length', 'ROM', 'passive torque', 'SWV and size of sciatic nerve', 'maximal ankle dorsiflexion range of motion (ROM) and passive torque, shear wave velocity (SWV; an index of stiffness) and architecture of triceps surae and sciatic nerve', 'sciatic nerve SWV']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0036394', 'cui_str': 'Structure of sciatic nerve'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",60.0,0.0723014,"Compared with the control group (mean; 95% Confidence Interval), muscle-directed intervention showed increased ROM (+7.3°; 95% CI: 4.1-10.5), decreased SWV of triceps surae (varied from -0.8 to -2.3m/s across muscles), decreased passive torque (-6.8N.m; 95% CI: -11.9 to -1.7), and greater gastrocnemius medialis fascicle length (+0.4cm; 95% CI: 0.1 to 0.8).","[{'ForeName': 'Ricardo J', 'Initials': 'RJ', 'LastName': 'Andrade', 'Affiliation': 'Faculty of Sport Sciences, University of Nantes, France.'}, {'ForeName': 'Sandro R', 'Initials': 'SR', 'LastName': 'Freitas', 'Affiliation': 'Faculdade de Motricidade Humana, Universidade de Lisboa, Portugal.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Hug', 'Affiliation': ""Laboratory EA 4334 'Movement, Interactions, Performance, University of Nantes, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Le Sant', 'Affiliation': 'Laboratory « Movement, Interactions, Performance » (EA 4334), Faculty of Sport Sciences, University of Nantes, France.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lacourpaille', 'Affiliation': 'EA 4334 ""Motricité, Interactions, Performance"", UFR STAPS, University of Nantes, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Service de MPR neurologique, CHU de Nantes, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Quillard', 'Affiliation': 'Laboratory « Movement, Interactions, Performance » (EA 4334), Faculty of Sport Sciences, University of Nantes, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McNair', 'Affiliation': 'Health and Rehabilitation Research Institute, Faculty of Health and Environmental Sciences, Auckland Institute of Technology, New Zealand.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Nordez', 'Affiliation': 'Laboratory ""Movement, Interactions, Performance"", Faculty of Sport Sciences, University of Nantes, France.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00239.2019']
2747,32853271,A clinical algorithm for same-day HIV treatment initiation in settings with high TB symptom prevalence in South Africa: The SLATE II individually randomized clinical trial.,"BACKGROUND


Many countries encourage same-day initiation of antiretroviral therapy (ART), but evidence on eligibility for same-day initiation, how best to implement it, and its impact on outcomes remains scarce. Building on the Simplified Algorithm for Treatment Eligibility (SLATE) I trial, in which nearly half of participants were ineligible for same-day initiation mainly because of TB symptoms, the study evaluated the revised SLATE II algorithm, which allowed same-day initiation for patients with mild TB symptoms and other less serious reasons for delay.
METHODS AND FINDINGS


SLATE II was a nonblinded, 1:1 individually randomized pragmatic trial at three primary healthcare clinics in Johannesburg, South Africa. It randomized adult patients presenting for an HIV test or any HIV care but not yet on ART. Intervention arm patients were assessed with a symptom screen, medical history, brief physical examination, and readiness questionnaire to distinguish between patients eligible for immediate ART dispensing and those requiring further care before initiation. Standard arm patients received usual care. Follow-up was by review of routine clinic records. Primary outcomes were (1) ART initiation in ≤7 days and (2) ART initiation in ≤28 days and retention in care at 8 months (composite outcome). From 14 March to 18 September 2018, 593 adult HIV+, nonpregnant patients were enrolled (median interquartile range [IQR] age 35 [29-43]; 63% (n = 373) female; median CD4 count 293 [133-487]). Half of study patients (n = 295) presented with TB symptoms, whereas only 13 (4%) standard arm and 7 (2%) intervention arm patients tested positive for TB disease. Among 140 intervention arm patients with TB symptoms, 72% were eligible for same-day initiation. Initiation was higher in the intervention (n = 296) versus standard arm (n = 297) by 7 days (91% versus 68%; risk difference [RD] 23% [95% confidence interval (CI) 17%-29%]) and 28 days (94% versus 82%; RD 12% [7%-17%]) after enrollment. In total, 87% of intervention and 38% of standard arm patients initiated on the same day. By 8 months after study enrollment, 74% (220/296) of intervention and 59% (175/297) of standard arm patients had both initiated ART in ≤28 days and been retained in care (RD 15% [7%-23%]). Among the 41% of participants with viral load results available, suppression was 90% in the standard arm and 92% in the intervention arm among patients initiated in ≤28 days. No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up. Limitations of the study included limited geographic generalizability, exclusion of patients too sick to consent, fluctuations in procedures in the standard arm over the course of the study, high fidelity to the trial protocol by study staff, and the possibility of overestimating loss to follow-up due to data constraints.
CONCLUSIONS


More than 85% of patients presenting for HIV testing or care, including those newly diagnosed, were eligible and ready for same-day initiation under the SLATE II algorithm. The algorithm increased initiation within 7 days without appearing to compromise retention and viral suppression at 8 months, offering a practical and acceptable approach that can be widely and immediately utilized by existing providers.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018.",2020,No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up.,"['140 intervention arm patients with TB symptoms, 72% were eligible for same-day initiation', 'adult patients presenting for an HIV test or any HIV care but not yet on ART', 'From 14 March to 18 September 2018, 593 adult HIV+, nonpregnant patients were enrolled (median interquartile range [IQR] age 35 [29-43]; 63% (n = 373) female; median CD4 count 293 [133-487', 'Intervention arm patients were assessed with a symptom screen, medical history, brief physical examination, and readiness questionnaire to distinguish between patients eligible for immediate ART dispensing and those requiring further care before initiation', 'settings with high TB symptom prevalence in South Africa', 'SLATE II was a nonblinded, 1:1 individually randomized pragmatic trial at three primary healthcare clinics in Johannesburg, South Africa']",['usual care'],"['ART initiation in ≤7 days and (2) ART initiation in ≤28 days and retention in care', 'adverse events', 'Initiation', 'TB symptoms']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",3.0,0.352693,No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up.,"[{'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Maskew', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alana T', 'Initials': 'AT', 'LastName': 'Brennan', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lungisile', 'Initials': 'L', 'LastName': 'Vezi', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003226']
2748,32853281,Auricular stimulation vs. expressive writing for exam anxiety in medical students - A randomized crossover investigation.,"OBJECTIVE


Auricular stimulation (AS) is a promising method in the treatment of situational anxiety. Expressive writing (EW) is an established psychological method, which reduces test anxiety and improves exam results. The aim of this crossover trial was to compare AS with EW, and with the no intervention (NI) condition, for treatment of exam anxiety.
METHODS


Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized. AS was applied using indwelling fixed needles bilaterally at the areas innervated mostly by the auricular branch of the vagal nerve on the day before the exam. Anxiety level, measured using State-Trait-Anxiety Inventory (STAI) before and after the interventions and immediately before exam, was the primary outcome. Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA) were analyzed across 3 conditions.
RESULTS


All 37 included participants completed the study. Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam. After EW and NI anxiety increased on the day of exam in comparison with baseline (P<0.01). Quality of sleep improved after AS in comparison with both control conditions (P<0.01). The activity of sAA decreased after EW and after AS (P<0.05) but not after NI condition.
CONCLUSION


Auricular stimulation, but not expressive writing, reduced exam anxiety and improved quality of sleep in medical students. These changes might be due to reduced activity of the sympathetic nervous system.",2020,Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam.,"['All 37 included participants completed the study', 'Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized', 'medical students']","['Auricular stimulation vs. expressive writing', 'Auricular stimulation (AS', 'Expressive writing (EW']","['Quality of sleep', 'activity of sAA', 'Anxiety level, measured using State-Trait-Anxiety Inventory (STAI', 'Anxiety level (STAI', 'Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA', 'NI anxiety', 'expressive writing, reduced exam anxiety and improved quality of sleep']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",37.0,0.023505,Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam.,"[{'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Usichenko', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wenzel', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Klausenitz', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Petersmann', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesse', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Neumann', 'Affiliation': 'Institute of Diagnostic Radiology and Neuroradiology, Functional Imaging Unit, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hahnenkamp', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0238307']
2749,32856073,Follicular flushing leads to higher oocyte yield in monofollicular IVF: a randomized controlled trial.,"STUDY QUESTION


Does follicular flushing increase the number of mature oocytes in monofollicular IVF?
SUMMARY ANSWER


Follicular flushing increases the number of mature oocytes in monofollicular IVF.
WHAT IS KNOWN ALREADY


Flushing increases neither the oocyte yield nor the pregnancy rate in polyfollicular IVF or in poor responder patients. In monofollicular IVF, the effect of flushing has so far been addressed by two studies: (i) a prospective study with minimal stimulation IVF demonstrated an increased oocyte yield, and (ii) a retrospective study with natural cycle (NC)-IVF showed an increased oocyte yield and an increased transfer rate.
STUDY DESIGN, SIZE, DURATION


Randomized controlled trial including 164 women who were randomized for either aspiration with or without flushing from 2016 to 2019.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Infertile women 18-42 years of age with an indication for IVF treatment at a university-based infertility unit. Women undergoing monofollicular IVF were randomized to either follicular aspiration only or follicular aspiration directly followed by five follicular flushes at a 1:1 ratio. The intervention was done without anaesthesia, using a gauge 19 single-lumen needle. Flushing volume was calculated (sphere formula) based on the size of the follicle.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 164 women were included; 81 were allocated to 'aspiration only' and 83 to additional 'flushing'. Primary analysis was based on the intention-to-treat: oocyte yield, defined as the collected mature oocyte rate, was higher (n = 64/83, 77.1%) in the flushing group compared to the aspiration only group (n = 48/81, 59.3%, adjusted risk difference (RD): 18.2% (95% CI 3.9-31.7%), P-value = 0.02). In the flushing group, most oocytes were retrieved within the first three flushes (63/83, 75.8%). Fertilization rate was higher in the flushing group (n = 53/83, 63.9% vs n = 38/81, 46.9%; adjusted RD: 16.8% (96% CI 1.5-31.4%), P = 0.045). Transfer rate was also higher in the flushing group (n = 52/83, 62.7% vs n = 38/81, 46.9%; RD: 15.71 (95% CI 0.3-30.3%)), but the difference was not significant (P = 0.06). The clinical pregnancy rate n = 9/83 versus n = 9/81 (RD: -0.3% (95% CI -9.9% to 9.5%)) and live birth rate n = 7/83 versus n = 8/81 (RD: -1.5% (95% CI -10.4% to 7.1%)) were not significantly different between the flushing and the aspiration group. The median duration of the intervention was significantly longer with flushing (2.38 min; quartiles 2.0, 2.7) versus aspiration only (0.43 min; quartiles 0.3, 0.5) (P < 0.01). There was no significant difference in the mean (±SD) visual analogue scales pain score between the follicular flushing (3.4 ± 1.8) and the aspiration group (3.1 ± 1.89).
LIMITATIONS, REASONS FOR CAUTION


Blinding of the procedure was not possible.
WIDER IMPLICATIONS OF THE FINDINGS


Our study proved that flushing of single follicles in NC-IVF increases the oocyte yield. In contrast to polyfollicular IVF flushing seems to be beneficial in a monofollicular setting if the technique used in our study (single-lumen needle, 5 flushings with flushing volume adaptation) is applied.
STUDY FUNDING/COMPETING INTEREST(S)


The study was funded by the financial sources of the division and in part by a research grant provided by NMS Biomedical SA, Switzerland. The company did not have any roles in design or conduct of the study or in the preparation of the manuscript. The authors have no other conflicts of interest.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov NCT02641808.
TRIAL REGISTRATION DATE


29 December 2015.
DATE OF FIRST PATIENT’S ENROLMENT


22 August 2016.",2020,"There was no significant difference in the mean (±SD) visual analogue scales pain score between the follicular flushing (3.4 ± 1.8) and the aspiration group (3.1 ± 1.89).
","['n\u2009=\u20099/83 versus n\u2009=\u20099/81 (RD', '29 December 2015', ""A total of 164 women were included; 81 were allocated to 'aspiration only' and 83 to additional 'flushing"", '164 women who were randomized for either aspiration with or without flushing from 2016 to 2019', 'Women undergoing monofollicular IVF', 'Infertile women 18-42 years of age with an indication for IVF treatment at a university-based infertility unit', '’S ENROLMENT\n\n\n22 August 2016', '\u20098/81 (RD']",['follicular aspiration only or follicular aspiration directly followed by five follicular flushes'],"['Fertilization rate', 'Transfer rate', 'clinical pregnancy rate', 'median duration of the intervention', 'Flushing volume', 'live birth rate', 'intention-to-treat: oocyte yield, defined as the collected mature oocyte rate', 'mean (±SD) visual analogue scales pain score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",164.0,0.16421,"There was no significant difference in the mean (±SD) visual analogue scales pain score between the follicular flushing (3.4 ± 1.8) and the aspiration group (3.1 ± 1.89).
","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Kohl Schwartz', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Calzaferri', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roumet', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Limacher', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wueest', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Weidlinger', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Mitter', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Leeners', 'Affiliation': 'Department of Reproductive Endocrinology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Von Wolff', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa165']
2750,32856124,Loss of bone density and bone strength following premenopausal risk-reducing bilateral salpingo-oophorectomy: a prospective controlled study (WHAM Study).,"Prophylactic oophorectomy is recommended for women at high risk for ovarian cancer, but the associated impact on bone health is of clinical concern. This prospective, controlled study demonstrated substantial loss of bone density and bone strength following surgical menopause. Postoperative hormone therapy alleviated, but not fully prevented, spinal bone loss.
INTRODUCTION


This prospective study investigated bone health in women following premenopausal oophorectomy.
METHODS


Dual-energy x-ray absorptiometry (DXA), peripheral quantitative computed tomography (pQCT), and pQCT-based finite element analysis (pQCT-FEA) were used to assess bone health between systemic hormone therapy (HT) users and non-users after premenopausal risk-reducing bilateral salpingo-oophorectomy (RRBSO) compared with premenopausal controls over 24-month follow-up.
RESULTS


Mean age was 42.4 ± 2.6 years (n = 30) for the surgery group and 40.2 ± 6.3 years for controls (n = 42), and baseline bone measures were similar between groups. Compromised bone variables were observed at 24 months after RRBSO, among which areal bone mineral density (aBMD) at the lumbar spine, tibial volumetric cortical density (Crt vBMD), and tibial bending stiffness (k bend ) had decreased by 4.7%, 1.0%, and 12.1%, respectively (all p < 0.01). In non-HT users, significant losses in lumbar spine (5.8%), total hip (5.2%), femoral neck (6.0%) aBMD, tibial Crt vBMD (2.3%), and k bend  (14.8%) were observed at 24 months (all p < 0.01). HT prevented losses in k bend , tibial Crt vBMD, and aBMD, except for modest 2.3% loss at the lumbar spine (p = 0.01).
CONCLUSION


This prospective, controlled study of bone health following RRBSO or premenopausal oophorectomy demonstrated substantial loss of bone density and bone strength following RRBSO. HT prevented loss of bone density and bone stiffness, although there was still a modest decrease in lumbar spine aBMD in HT users. These findings may inform decision-making about RRBSO and clinical management following premenopausal oophorectomy.",2020,"HT prevented losses in k bend , tibial Crt vBMD, and aBMD, except for modest 2.3% loss at the lumbar spine (p = 0.01).
","['women following premenopausal oophorectomy', 'surgical menopause', 'Mean age was 42.4\u2009±\u20092.6\xa0years (n\u2009=\u200930) for the surgery group and 40.2\u2009±\u20096.3\xa0years for controls (n\u2009=\u200942', 'women at high risk for ovarian cancer']","['premenopausal risk-reducing bilateral salpingo-oophorectomy', 'Dual-energy x-ray absorptiometry (DXA), peripheral quantitative computed tomography (pQCT), and pQCT-based finite element analysis (pQCT-FEA', 'systemic hormone therapy (HT) users and non-users after premenopausal risk-reducing bilateral salpingo-oophorectomy (RRBSO', 'HT', 'Prophylactic oophorectomy']","['bone health', 'bone density and bone stiffness', 'femoral neck', 'aBMD, tibial Crt vBMD', 'bone density and bone strength', 'lumbar spine aBMD', 'areal bone mineral density (aBMD) at the lumbar spine, tibial volumetric cortical density (Crt vBMD), and tibial bending stiffness (k bend ', 'lumbar spine', 'spinal bone loss', 'total hip', 'Compromised bone variables', 'HT prevented losses in k bend , tibial Crt vBMD, and aBMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0029936', 'cui_str': 'Oophorectomy'}, {'cui': 'C0740421', 'cui_str': 'Postsurgical menopause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600552', 'cui_str': 'Analysis, Finite Element'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C2945703', 'cui_str': 'Prophylactic oophorectomy'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0011119', 'cui_str': 'Bends'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]",,0.0268968,"HT prevented losses in k bend , tibial Crt vBMD, and aBMD, except for modest 2.3% loss at the lumbar spine (p = 0.01).
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, 3050, Australia.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Robinson', 'Affiliation': 'Department of Biomedical Engineering, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'P V S', 'Initials': 'PVS', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Krejany', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Melbourne and Royal Women's Hospital, Parkville, Australia.""}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Yates', 'Affiliation': 'Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, 3050, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hickey', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Melbourne and Royal Women's Hospital, Parkville, Australia.""}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Wark', 'Affiliation': 'Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, 3050, Australia. jdwark@unimelb.edu.au.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05608-5']
2751,32856146,A comparison between short- and long-term D-J stent in Anderson-Hynes pyeloplasty for pelvi-ureteric junction obstruction.,"PURPOSE


A double-J (D-J) stent is usually kept in situ during Anderson-Hynes (A-H) pyeloplasty for pelvi-ureteric junction (PUJ) obstruction. The aim of the study is to determine whether early removal of D-J stent is better than long-term stenting.
METHODS


In this prospective comparative study, conducted from January 2018 to April 2019 in Chittagong Medical College Hospital, patients with PUJ obstruction, age less than 12 years, were divided into group A (long-term stenting) and group B (short-term stenting) by simple randomization. Main outcome variables were urinary tract infection (UTI), stent colonization, encrustation, renal cortical thickness, differential renal function (DRF), glomerular filtration rate (GFR), and flow rate in DTPA renogram.
RESULTS


There were 31 patients in each group. Median age was 5 years (IQR: 2.3 to 7 years) and male to female ratio was 2.1:1. Frequency of post-operative UTI and stent colonization were significantly higher in group A than group B (p < 0.001). All the patients of both groups had similar improvement in renal cortical thickness, DRF, GFR, and flow rate. The study was potentially limited by its small sample size and high median age (5 years).
CONCLUSION


Early removal of D-J stent had lower incidence of UTI, stent colonization, encrustation, and stent migration.",2020,Frequency of post-operative UTI and stent colonization were significantly higher in group A than group B (,"['small sample size and high median age (5\xa0years', 'Median age was 5\xa0years (IQR: 2.3 to 7\xa0years) and male to female ratio was 2.1:1', 'Anderson-Hynes pyeloplasty for pelvi-ureteric junction obstruction', 'conducted from January 2018 to April 2019 in Chittagong Medical College Hospital, patients with PUJ obstruction, age less than 12\xa0years']","['short- and long-term D-J stent', 'double-J (D-J) stent']","['incidence of UTI, stent colonization, encrustation, and stent migration', 'renal cortical thickness, DRF, GFR, and flow rate', 'Frequency of post-operative UTI and stent colonization', 'urinary tract infection (UTI), stent colonization, encrustation, renal cortical thickness, differential renal function (DRF), glomerular filtration rate (GFR), and flow rate in DTPA renogram']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}, {'cui': 'C0521619', 'cui_str': 'Obstruction of pelviureteric junction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C4087543', 'cui_str': 'Stent migration'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0430198', 'cui_str': 'Differential renal function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013254', 'cui_str': 'Pentetic acid'}]",,0.0356155,Frequency of post-operative UTI and stent colonization were significantly higher in group A than group B (,"[{'ForeName': 'Md Sharif', 'Initials': 'MS', 'LastName': 'Imam', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Md Abdullah', 'Initials': 'MA', 'LastName': 'Al Farooq', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Md Khurshid Alam', 'Initials': 'MKA', 'LastName': 'Sarwar', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Tanvir Kabir', 'Initials': 'TK', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh. ivan_tanvir@yahoo.com.'}, {'ForeName': 'Rajib', 'Initials': 'R', 'LastName': 'Khastagir', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Habib', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Walid', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}]",Pediatric surgery international,['10.1007/s00383-020-04734-9']
2752,32856168,Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.,"Item response theory (IRT) was used to characterize the time course of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH-LUTS) measured by item-level International Prostate Symptom Scores (IPSS). The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined. Data from 403 patients with moderate-to-severe BPH-LUTS in a placebo-controlled phase II trial studying the effect of degarelix over 6 months were used for modeling. Three pharmacometric models were developed: a model for total IPSS, a unidimensional IRT model, and a bidimensional IRT model, the latter separating voiding and storage items. The population-level time course of BPH-LUTS in all models was described by initial improvement followed by worsening. In the unidimensional IRT model, the combined information content of IPSS voiding items represented 72% of the total information content, indicating that the voiding subscore may be more sensitive to changes in BPH-LUTS compared with the storage subscore. The pharmacometric models showed considerably higher power to detect a drug effect compared with a cross-sectional and while-on-treatment analysis of covariance, respectively. Compared with the sample size required to detect a drug effect at 80% power with the total IPSS model, a reduction of 5.9% and 11.7% was obtained with the unidimensional and bidimensional IPSS IRT model, respectively. Pharmacometric IRT analysis of the IPSS within BPH-LUTS may increase the precision and efficiency of treatment effect assessment, albeit to a more limited extent compared with applications in other therapeutic areas.",2020,The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined.,"['403 patients with moderate-to-severe BPH-LUTS in a', 'Patients with Lower Urinary Tract Symptoms']","['degarelix', 'placebo']",['Item response theory (IRT'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],403.0,0.0227785,The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined.,"[{'ForeName': 'Yassine Kamal', 'Initials': 'YK', 'LastName': 'Lyauk', 'Affiliation': 'Translational Medicine, Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen, Denmark. yassinekamallyauk@gmail.com.'}, {'ForeName': 'Daniël M', 'Initials': 'DM', 'LastName': 'Jonker', 'Affiliation': 'Translational Medicine, Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen, Denmark.'}, {'ForeName': 'Trine Meldgaard', 'Initials': 'TM', 'LastName': 'Lund', 'Affiliation': 'Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Hooker', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}]",The AAPS journal,['10.1208/s12248-020-00500-w']
2753,32856189,Lean-seafood intake increases urinary iodine concentrations and plasma selenium levels: a randomized controlled trial with crossover design.,"PURPOSE


Iodine deficiency due to insufficient nutritional intake is a public health challenge in several European countries, including Norway. Lean-seafood has a high iodine and arsenic (As) content and is a good source of selenium (Se). Evidence of a direct effect of increased intake of lean-seafood on iodine status is limited. The main aims were to determine the iodine status at baseline and to investigate possible dietary effects on urinary iodine concentration (UIC) after intervention with lean-seafood versus non-seafood. Plasma Se, and plasma and urinary As concentrations were also measured.
METHODS


A randomized controlled crossover study comprising two 4 weeks experimental periods with two balanced diets varied in main proteins (60% of total dietary proteins) of lean-seafood and non-seafood, separated by a 5 week washout period.
RESULTS


Twenty participants (7 males, 13 females) were included and the mean ± SD age was 50.6 ± 15.3 years for all participants. Fasting UIC was median (25th, 75th percentile) 70 (38, 110) and 79 (49, 94) µg/L in the lean-seafood and non-seafood intervention at baseline, respectively. UIC increased after 4 weeks of the lean-seafood intervention to 135 (110, 278) µg/L, but not after the non-seafood intervention [58 (33, 91) µg/L] (P diet-effect < 0.001). Fasting plasma Se increased in the lean-seafood intervention and decreased in the non-seafood intervention (P diet-effect = 0.001). Fasting urinary and plasma As increased in the lean-seafood intervention and was unchanged in the non-seafood intervention (P diet-effect < 0.001).
CONCLUSION


The participant's UIC was below the recommended median (100 µg/L) at baseline, but increased sufficiently after a 4 week intervention with lean-seafood.",2020,Fasting plasma Se increased in the lean-seafood intervention and decreased in the non-seafood intervention (P diet-effect = 0.001).,"['two 4\xa0weeks experimental periods with two balanced diets varied in main proteins (60% of total dietary proteins) of lean-seafood and non-seafood, separated by a 5\xa0week washout period', 'Twenty participants (7 males, 13 females) were included and the mean\u2009±\u2009SD age was 50.6\u2009±\u200915.3\xa0years for all participants']","['Lean-seafood intake', 'lean-seafood versus non-seafood']","['UIC', 'Fasting UIC', 'Fasting plasma Se', 'Plasma Se, and plasma and urinary', 'urinary iodine concentration (UIC', 'urinary iodine concentrations and plasma selenium levels', 'Fasting urinary and plasma']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0559272', 'cui_str': 'Seafood intake'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}]","[{'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0858169', 'cui_str': 'Plasma selenium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0322473,Fasting plasma Se increased in the lean-seafood intervention and decreased in the non-seafood intervention (P diet-effect = 0.001).,"[{'ForeName': 'Jannike', 'Initials': 'J', 'LastName': 'Øyen', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway. jannike.oyen@hi.no.'}, {'ForeName': 'Eli Kristin', 'Initials': 'EK', 'LastName': 'Aadland', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Liaset', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Even', 'Initials': 'E', 'LastName': 'Fjære', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Madsen', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02366-2']
2754,32856410,The efficiency of vein viewing on pain and anxiety of children during peripheral cannula intervention: A randomized controlled study.,"AIM


The purpose of this research is to estimate the efficiency of vein viewing device on 9-12 year-old children's pain and anxiety.
METHODS


The research has been designed as an experimental study including pre-and post-test and control groups. Data were collected with personal information form, facial expressions rating scale, state anxiety scale, vein viewing device and a peripheral cannula. Both groups were applied to the state anxiety scale before and after the procedure while the facial expressions rating scale was applied during the procedure.
RESULTS


Statistically significant difference was found between experimental and control groups regarding processing time, number of transaction attempts and facial expressions rating scale score averages. While there was no difference regarding the state anxiety scales average points of children in experimental and control groups before the procedure, a statistically significant difference was found in an advanced level regarding post-processing state anxiety levels.
CONCLUSIONS


Usage of vein viewing device during peripheral cannula intervention reduces children's pain and anxiety levels and shortens the durations of the initiative.",2020,"Statistically significant difference was found between experimental and control groups regarding processing time, number of transaction attempts and facial expressions rating scale score averages.","[""9-12\u2009year-old children's pain and anxiety"", 'children during peripheral cannula intervention']","['vein viewing device', 'vein viewing', 'peripheral cannula intervention']","['state anxiety scales', 'pain and anxiety', 'facial expressions rating scale', ""children's pain and anxiety levels"", 'facial expressions rating scale, state anxiety scale, vein viewing device and a peripheral cannula', 'processing time, number of transaction attempts and facial expressions rating scale score averages', 'state anxiety scale']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0249999,"Statistically significant difference was found between experimental and control groups regarding processing time, number of transaction attempts and facial expressions rating scale score averages.","[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Bayram', 'Affiliation': 'Zonguldak Bülent Ecevit University, Health Application and Research Center, Zonguldak, Turkey.'}, {'ForeName': 'Aysel', 'Initials': 'A', 'LastName': 'Topan', 'Affiliation': 'Zonguldak Bulent Ecevit University, Faculty of Health Sciences, Dept. of Nursing, Zonguldak, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12364']
2755,32856448,A comparative study of combined intravenous and topical administration of tranexamic acid with topical tranexamic acid alone for blood loss reduction after primary uncemented total hip arthroplasty.,"The aim of the present study was to evaluate the efficacy of topical versus combined (intravenous + topical) tranexamic acid (TXA) to reduce perioperative blood loss after uncemented primary total hip arthroplasty (THA). Seventy-five patients were randomized in three comparable experimental groups: 1) topical TXA (3 g in 50 ml of saline solution); 2) intravenous + topical TXA (3 g topical + 2 g in 100 ml of saline solution intravenously); 3) controls. Pre- and post-operative hemoglobin (Hb) levels and hematocrit (Hct) values along with the rate of blood transfusion in the 3 groups were compared. The intravenous + topical TXA group demonstrated higher Hb levels and Hct values at postoperative day one (Hb = p <0.05, Hct = p <0.001), postoperative day three (Hb = p <0.05, Hct = p <0.001), and discharge (Hct = p <0.01) compared to the control group. The intravenous + topical group had a lower transfusion rate compared to the control group (0% vs 20%, p = 0.014). With the numbers available, no difference in postoperative Hb level and transfusion rate emerged between topical TXA and control group.",2020,"The intravenous + topical group had a lower transfusion rate compared to the control group (0% vs 20%, p = 0.014).","['after uncemented primary total hip arthroplasty (THA', 'Seventy-five patients', 'after primary uncemented total hip arthroplasty']","['tranexamic acid with topical tranexamic acid alone', 'intravenous + topical TXA', 'Pre- and post-operative hemoglobin', 'topical versus combined (intravenous + topical) tranexamic acid (TXA', 'topical TXA']","['transfusion rate', 'perioperative blood loss', 'postoperative Hb level and transfusion rate', 'Hb levels and Hct values', 'blood loss reduction', 'Hb) levels and hematocrit (Hct) values']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",75.0,0.0612338,"The intravenous + topical group had a lower transfusion rate compared to the control group (0% vs 20%, p = 0.014).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rizzo', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Russo', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guarino', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Izzo', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mariconda', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}]",Journal of biological regulators and homeostatic agents,[]
2756,32846328,Factors associated with discontinuation in the drug and placebo groups of trials of second generation antipsychotics for acute schizophrenia: A meta-regression analysis: Discontinuation in antipsychotic trials.,"This study investigated factors associated with discontinuation in double-blind, randomized, placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs) for acute schizophrenia, with a view to establishing what factors were associated with all-cause discontinuation. 77 eligible studies (96 comparisons; n = 22,678) were included in this study. Thirty-one factors potentially affecting all-cause discontinuation, related to the participants, study design, and drugs, were included in a meta-regression analysis that examined the factors associated with discontinuation rates in treatment and placebo groups and/or the treatment-placebo group difference in discontinuation. Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group. These factors were also associated with the treatment-placebo group difference in discontinuation. Although the risk of weight gain from SGA use was not associated with discontinuation rates in either the treatment or placebo groups, SGAs with a risk of weight gain were associated with a larger treatment-placebo group difference in discontinuation, although the reason is unknown. Factors associated with discontinuation rates in both treatment and placebo groups did not influence the treatment-placebo group difference in discontinuation. The efficacy and the risk of weight gain of SGAs seemed to influence treatment-placebo group difference in discontinuation in DBRPCTs of SGAs for acute schizophrenia.",2020,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","['acute schizophrenia', '77 eligible studies (96 comparisons; n\xa0=\xa022,678']","['placebo', 'placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs']","['Positive and Negative Syndrome Scale total scores', 'discontinuation rates', 'smaller response rates', 'weight gain']","[{'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",22678.0,0.223392,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan. Electronic address: tarok@fujita-hu.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Okuya', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.08.003']
2757,32846334,Effectiveness of pulmonary rehabilitation at high-altitude compared to sea-level in adults with severe refractory asthma.,"BACKGROUND


Beneficial effects of pulmonary rehabilitation at high-altitude (HAPR) in patients with severe refractory asthma have been reported earlier, but evidence for the effectiveness is limited.
AIM


To investigate the effectiveness of high-altitude pulmonary rehabilitation to comparable treatment at sea-level (LAPR) on patient outcome parameters.
METHODS


Adults with severe refractory asthma living in The Netherlands were included. Treatment consisted of a 12-week personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n = 93) or in a tertiary lung center at sea-level in The Netherlands (n = 45). At baseline, after treatment, and during 12 months follow-up asthma related quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose were assessed. Patients could not be randomized resulting in different asthma populations. Groups were compared using linear regression analysis (ANCOVA) adjusted for baseline values, in addition to age, atopy, smoking history, BMI and gender.
RESULTS


After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear regression analysis-5.29 mg, p = 0.003 and Crude Odds Ratio-1.67, p = 0.003, respectively) were observed in the HAPR-group compared to the LAPR group. Patients receiving HAPR also had less asthma exacerbations (≥1 exacerbation: 20% vs 60%,p < 0.001) and showed improvement in lung function (%predFEV 1  3.4%,p = 0.014) compared to the LAPR group, but at 12 months no differences between groups were observed.
CONCLUSION


HAPR resulted in a larger improvement in patient outcome parameters compared to LAPR, on the long run the improvement in patient reported symptoms and lower maintenance OCS-dose persists. Underlying factors that explain this observed effect need to be investigated.",2020,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","['patients with severe refractory asthma', 'adults with severe refractory asthma', 'Adults with severe refractory asthma living in The Netherlands were included']","['personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n\xa0=\xa093) or in a tertiary lung center at sea-level in The Netherlands', 'pulmonary rehabilitation at high-altitude (HAPR', 'HAPR', 'high-altitude pulmonary rehabilitation', 'pulmonary rehabilitation']","['asthma exacerbations', 'lung function', 'quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.06858,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'de Nijs', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands; Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Krop', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Portengen', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Rijssenbeek-Nouwens', 'Affiliation': 'Dutch Asthma Center Davos, Davos, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Vries', 'Affiliation': 'Merem Asthma Center Heideheuvel, Hilversum, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Weersink', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'H G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands. Electronic address: H.G.M.Heijerman@umcutrecht.nl.'}, {'ForeName': 'D J J', 'Initials': 'DJJ', 'LastName': 'Heederik', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'J W J', 'Initials': 'JWJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106123']
2758,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
2759,32846536,Paired preference tests and placebo placement: 1. Should placebo pairs be placed before or after the target pair?,"One type of paired preference test uses the 'target' pair of stimuli under consideration to record the measured preferences (prefer A, Prefer B, 'no preference') and a second putatively identical control pair, the 'placebo' pair (AA or BB) to indicate 'false' preferences, unrelated to the target pair, elicited by the effects of the testing situation. From the literature there is disagreement regarding whether it is important to place a placebo pair before or after its corresponding target pair, to elicit a greater proportion of 'no preference' responses. This is important, because the higher the frequency of 'no preference' responses in the placebo pair, the more powerful will be the chi-squared style analysis, which determines whether the target pair displays a significant preference or not. It has been hypothesized that placing the placebo pair after the target pair would elicit more 'no preference' responses in the placebo, because the consumers would have had a chance to experience the difference in sensory characteristics of the two stimuli in the target pair. Using a related samples design, the hypothesis was confirmed although the difference between placebos placed before and after the target was not always significant. It was hypothesized that this lack of significance was caused by greater variance among the items being assessed, making it more difficult to decide whether a putatively placebo pair, in the context of the experiment, was really 'identical'. Psychological adjustments in the consumers were discussed in terms of difference and preference tau criteria. A boost in the proportion of 'no preferences' was observed for the placebo pair built into the triadic preference test, this was explained by the experimenter gaining some control over the consumers' preference tau criteria.",2020,"A boost in the proportion of 'no preferences' was observed for the placebo pair built into the triadic preference test, this was explained by the experimenter gaining some control over the consumers' preference tau criteria.",[],"[""placebo' pair (AA or BB"", 'placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.156937,"A boost in the proportion of 'no preferences' was observed for the placebo pair built into the triadic preference test, this was explained by the experimenter gaining some control over the consumers' preference tau criteria.","[{'ForeName': 'Jeremia', 'Initials': 'J', 'LastName': 'Halim', 'Affiliation': 'Department of Food Science and Technology, University of California, Davis, CA, USA; Department of Food Technology, Universitas Pelita Harapan, Tangerang, Indonesia.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Davis Sensory Institute, Davis, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Mahony"", 'Affiliation': 'Department of Food Science and Technology, University of California, Davis, CA, USA; Davis Sensory Institute, Davis, CA, USA. Electronic address: maomahony@ucdavis.edu.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2020.109344']
2760,32853332,Intensive blood pressure control appears to be effective and safe in patients with peripheral artery disease: The Systolic Blood Pressure Intervention Trial (SPRINT).,Not required.,2020,Not required.,['patients with peripheral artery disease'],['Intensive blood pressure control'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0184041,Not required.,"[{'ForeName': 'Johanna Maria Christina', 'Initials': 'JMC', 'LastName': 'Frary', 'Affiliation': 'Department of Cardiology, North Zealand Hospital, Hillerød, Denmark.'}, {'ForeName': 'Manan', 'Initials': 'M', 'LastName': 'Pareek', 'Affiliation': 'Department of Cardiology, North Zealand Hospital, Hillerød, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Byrne', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Rujic', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristian Hay', 'Initials': 'KH', 'LastName': 'Kragholm', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas Bastholm', 'Initials': 'TB', 'LastName': 'Olesen', 'Affiliation': 'Department of Internal Medicine, Hospital of Little Belt, Kolding, Denmark.'}, {'ForeName': 'Michael Hecht', 'Initials': 'MH', 'LastName': 'Olsen', 'Affiliation': 'Holbæk Hospital, Division of Cardiology, Department of Internal Medicine, Holbæk, Denmark.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA, USA.""}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvaa102']
2761,32853384,Spatially Fractionated Radiation Therapy Using Lattice Radiation in Far-advanced Bulky Cervical Cancer: A Clinical and Molecular Imaging and Outcome Study.,"Spatially fractionated radiation therapy (SFRT) has shown promise in generating high tumor response and local control in the treatment of various palliative and locally advanced bulky tumors. SFRT has not yet been studied systematically in cancer of the cervix. Here we report the first series of patients receiving SFRT for advanced/bulky cervical cancer. Ten patients with far-advanced bulky cervical cancer, stage IIIB-IVA (seven squamous cell and three adeno/adenosquamous carcinomas) received lattice radiation therapy (LRT), a variant of SFRT. The LRT regimen consisted of a dose of 24 Gy in three fractions, given to an average of five high-dose spheres within the gross tumor volume (GTV). The dose in the peripheral GTV was limited to 9 Gy in three factions, using the volumetric modulated arc therapy (VMAT) technique. LRT was followed subsequently by conventionally fractionated external beam irradiation to 44.28 Gy (range: 39.60-45.00 Gy in 1.8 Gy fractions). All patients received concurrent cisplatin chemotherapy. Tumor response was assessed clinically, by morphological imaging (CT, MRI) and 18FDG PET/CT. Tumor control and survival rates were estimated using Kaplan-Meier analysis. All patients had local control at a median follow-up of 16 months (1-77). The two-year disease-specific survival rate was 53.3%. All cancer deaths were due to metastatic failure with local control maintained. Among the three patients who died of disease, all had adeno- or adenosquamous carcinoma histology, and no deaths from disease occurred among the patients with squamous cell carcinoma (P = 0.010). There was no grade ≥3 short-term or long-term treatment-related complications. Intra-treatment morphological tumor regression was highly variable (mean: 54%, range: 6-91%). After therapy, the complete metabolic response was 88.9% (8/9), and one patient out of the nine patients with post-treatment PET-CT had partial response (11.1%). Our preliminary data suggest that LRT-based SFRT is well tolerated in patients with far-advanced bulky cervical cancer and results in favorable tumor responses and high local control. These observations confirm prior reports of favorable tumor control and toxicity outcomes with SFRT in other advanced/bulky malignancies. Our findings are corroborated by high molecular-imaging-based tumor response. These encouraging hypothesis-generating results require cautious interpretation and confirmation with larger patient cohorts, preferably through a multi-institutional controlled randomized clinical trial.",2020,"The dose in the peripheral GTV was limited to 9 Gy in three factions, using the volumetric modulated arc therapy (VMAT) technique.","['patients with far-advanced bulky cervical cancer', 'Ten patients with far-advanced bulky cervical cancer, stage IIIB-IVA (seven squamous cell and three adeno/adenosquamous carcinomas', 'Far-advanced Bulky Cervical Cancer', 'patients receiving SFRT for advanced/bulky cervical cancer']","['Spatially Fractionated Radiation Therapy Using Lattice Radiation', 'volumetric modulated arc therapy (VMAT) technique', 'concurrent cisplatin chemotherapy', 'SFRT', 'LRT', 'LRT-based SFRT', 'lattice radiation therapy (LRT', 'Spatially fractionated radiation therapy (SFRT']","['adeno- or adenosquamous carcinoma histology', 'grade ≥3 short-term or long-term treatment-related complications', 'Tumor control and survival rates', 'partial response', 'Tumor response', 'disease-specific survival rate', 'complete metabolic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0221910', 'cui_str': 'Squamous epithelial cell'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",10.0,0.0285467,"The dose in the peripheral GTV was limited to 9 Gy in three factions, using the volumetric modulated arc therapy (VMAT) technique.","[{'ForeName': 'Beatriz E', 'Initials': 'BE', 'LastName': 'Amendola', 'Affiliation': 'Innovative Cancer Institute, Miami, Florida.'}, {'ForeName': 'Naipy C', 'Initials': 'NC', 'LastName': 'Perez', 'Affiliation': 'Innovative Cancer Institute, Miami, Florida.'}, {'ForeName': 'Nina A', 'Initials': 'NA', 'LastName': 'Mayr', 'Affiliation': 'Department of Radiation Oncology, University of Washington School of Medline, Seattle, Washington.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Innovative Cancer Institute, Miami, Florida.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Amendola', 'Affiliation': 'Innovative Cancer Institute, Miami, Florida.'}]",Radiation research,['10.1667/RADE-20-00038.1']
2762,32853410,Interventions for American cutaneous and mucocutaneous leishmaniasis.,"BACKGROUND


On the American continent, cutaneous and mucocutaneous leishmaniasis (CL and MCL) are diseases associated with infection by several species of Leishmania parasites. Pentavalent antimonials remain the first-choice treatment. There are alternative interventions, but reviewing their effectiveness and safety is important as availability is limited. This is an update of a Cochrane Review first published in 2009.
OBJECTIVES


To assess the effects of interventions for all immuno-competent people who have American cutaneous and mucocutaneous leishmaniasis (ACML).
SEARCH METHODS


We updated our database searches of the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, LILACS and CINAHL to August 2019. We searched five trials registers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) assessing either single or combination treatments for ACML in immuno-competent people, diagnosed by clinical presentation and Leishmania infection confirmed by smear, culture, histology, or polymerase chain reaction on a biopsy specimen. The comparators were either no treatment, placebo only, or another active compound.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. Our key outcomes were the percentage of participants 'cured' at least three months after the end of treatment, adverse effects, and recurrence. We used GRADE to assess evidence certainty for each outcome.
MAIN RESULTS


We included 75 studies (37 were new), totalling 6533 randomised participants with ATL. The studies were mainly conducted in Central and South America at regional hospitals, local healthcare clinics, and research centres. More male participants were included (mean age: roughly 28.9 years (SD: 7.0)). The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana. The most assessed interventions and comparators were non-antimonial systemics (particularly oral miltefosine) and antimonials (particularly meglumine antimoniate (MA), which was also a common intervention), respectively. Three studies included moderate-to-severe cases of mucosal leishmaniasis but none included cases with diffuse cutaneous or disseminated CL, considered the severe cutaneous form. Lesions were mainly ulcerative and located in the extremities and limbs. The follow-up (FU) period ranged from 28 days to 7 years. All studies had high or unclear risk of bias in at least one domain (especially performance bias). None of the studies reported the degree of functional or aesthetic impairment, scarring, or quality of life. Compared to placebo, at one-year FU, intramuscular (IM) MA given for 20 days to treat L. braziliensis and L. panamensis infections in ACML may increase the likelihood of complete cure (risk ratio (RR) 4.23, 95% confidence interval (CI) 0.84 to 21.38; 2 RCTs, 157 participants; moderate-certainty evidence), but may also make little to no difference, since the 95% CI includes the possibility of both increased and reduced healing (cure rates), and IMMA probably increases severe adverse effects such as myalgias and arthralgias (RR 1.51, 95% CI 1.17 to 1.96; 1 RCT, 134 participants; moderate-certainty evidence). IMMA may make little to no difference to the recurrence risk, but the 95% CI includes the possibility of both increased and reduced risk (RR 1.79, 95% CI 0.17 to 19.26; 1 RCT, 127 participants; low-certainty evidence). Compared to placebo, at six-month FU, oral miltefosine given for 28 days to treat L. mexicana, L. panamensis and L. braziliensis infections in American cutaneous leishmaniasis (ACL) probably improves the likelihood of complete cure (RR 2.25, 95% CI 1.42 to 3.38), and probably increases nausea rates (RR 3.96, 95% CI 1.49 to 10.48) and vomiting (RR 6.92, 95% CI 2.68 to 17.86) (moderate-certainty evidence). Oral miltefosine may make little to no difference to the recurrence risk (RR 2.97, 95% CI 0.37 to 23.89; low-certainty evidence), but the 95% CI includes the possibility of both increased and reduced risk (all based on 1 RCT, 133 participants). Compared to IMMA, at 6 to 12 months FU, oral miltefosine given for 28 days to treat L. braziliensis, L. panamensis, L. guyanensis and L. amazonensis infections in ACML may make little to no difference to the likelihood of complete cure (RR 1.05, 95% CI 0.90 to 1.23; 7 RCTs, 676 participants; low-certainty evidence). Based on moderate-certainty evidence (3 RCTs, 464 participants), miltefosine probably increases nausea rates (RR 2.45, 95% CI 1.72 to 3.49) and vomiting (RR 4.76, 95% CI 1.82 to 12.46) compared to IMMA. Recurrence risk was not reported. For the rest of the key comparisons, recurrence risk was not reported, and risk of adverse events could not be estimated. Compared to IMMA, at 6 to 12 months FU, oral azithromycin given for 20 to 28 days to treat L. braziliensis infections in ACML probably reduces the likelihood of complete cure (RR 0.51, 95% CI 0.34 to 0.76; 2 RCTs, 93 participants; moderate-certainty evidence). Compared to intravenous MA (IVMA) and placebo, at 12 month FU, adding topical imiquimod to IVMA, given for 20 days to treat L. braziliensis, L. guyanensis and L. peruviana infections in ACL probably makes little to no difference to the likelihood of complete cure (RR 1.30, 95% CI 0.95 to 1.80; 1 RCT, 80 participants; moderate-certainty evidence). Compared to MA, at 6 months FU, one session of local thermotherapy to treat L. panamensis and L. braziliensis infections in ACL reduces the likelihood of complete cure (RR 0.80, 95% CI 0.68 to 0.95; 1 RCT, 292 participants; high-certainty evidence). Compared to IMMA and placebo, at 26 weeks FU, adding oral pentoxifylline to IMMA to treat CL (species not stated) probably makes little to no difference to the likelihood of complete cure (RR 0.86, 95% CI 0.63 to 1.18; 1 RCT, 70 participants; moderate-certainty evidence).
AUTHORS' CONCLUSIONS


Evidence certainty was mostly moderate or low, due to methodological shortcomings, which precluded conclusive results. Overall, both IMMA and oral miltefosine probably result in an increase in cure rates, and nausea and vomiting are probably more common with miltefosine than with IMMA. Future trials should investigate interventions for mucosal leishmaniasis and evaluate recurrence rates of cutaneous leishmaniasis and its progression to mucosal disease.",2020,"The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana.","['all immuno-competent people who have American cutaneous and mucocutaneous leishmaniasis (ACML', 'More male participants were included (mean age: roughly 28.9 years (SD: 7.0', '75 studies (37 were new), totalling 6533 randomised participants with ATL', 'American cutaneous and mucocutaneous leishmaniasis']","['IMMA', 'FU, intramuscular (IM) MA', 'Oral miltefosine', 'azithromycin', 'IMMA and placebo', 'placebo', 'intravenous MA (IVMA) and placebo', 'miltefosine']","['degree of functional or aesthetic impairment, scarring, or quality of life', 'recurrence risk', 'reduced healing (cure rates', 'vomiting', 'cure rates, and nausea and vomiting', 'likelihood of complete cure', 'Recurrence risk', 'nausea rates', 'adverse effects, and recurrence']","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C1328252', 'cui_str': 'American mucocutaneous leishmaniasis'}, {'cui': 'C1292772', 'cui_str': 'Atypical chronic myeloid leukemia, BCR/ABL negative'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0068006', 'cui_str': 'miltefosine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",6533.0,0.246987,"The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana.","[{'ForeName': 'Mariona', 'Initials': 'M', 'LastName': 'Pinart', 'Affiliation': 'Free time independent Cochrane reviewer, Berlin, Germany.'}, {'ForeName': 'José-Ramón', 'Initials': 'JR', 'LastName': 'Rueda', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of the Basque Country, Leioa, Spain.'}, {'ForeName': 'Gustavo As', 'Initials': 'GA', 'LastName': 'Romero', 'Affiliation': 'Center for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Pinzón-Flórez', 'Affiliation': 'Research Centre for Insurance Medicine, Keralty, Bogotá, Colombia.'}, {'ForeName': 'Karime', 'Initials': 'K', 'LastName': 'Osorio-Arango', 'Affiliation': 'Dirección de Redes en Salud Pública, Instituto Nacional de Salud, Bogotá, Colombia.'}, {'ForeName': 'Ana Nilce', 'Initials': 'AN', 'LastName': 'Silveira Maia-Elkhoury', 'Affiliation': 'Communicable Diseases and Environmental Determinants of Health (CDE), Neglected, Tropical and Vector Borne Diseases (VT), Pan American Health Organization/ World Health Organization (PAHO/WHO), Rio de Janeiro, Brazil.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Reveiz', 'Affiliation': 'Evidence and Intelligence for Action in Health Department, Pan American Health Organization (PAHO), Washington DC, USA.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Elias', 'Affiliation': 'Evidence and Intelligence for Action in Health Department, Pan American Health Organization (PAHO), Washington DC, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Tweed', 'Affiliation': 'c/o Cochrane Skin Group, The University of Nottingham, Nottingham, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004834.pub3']
2763,32853559,"Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.
METHODS


MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024.
FINDINGS


Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups.
INTERPRETATION


Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","['2595 women were identified as being eligible for the MifeMiso trial', '59 (17%) of 348 women in the', '696 (98%) of 711 women had available data for the primary outcome', 'Women with missed miscarriage', '354 women', 'Between Oct 3, 2017, and July 22, 2019', '28 UK hospitals', '62 (17%) of 355 women in the', 'maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre', 'missed miscarriage (MifeMiso', '711 women', 'Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent']","['mifepristone and misoprostol', 'mifepristone plus misoprostol', 'Mifepristone and misoprostol', 'prostaglandin misoprostol', 'misoprostol', 'mifepristone', 'placebo', 'placebo and misoprostol', 'placebo plus misoprostol', 'oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol']","['chance of successful miscarriage management', 'failure to spontaneously pass the gestational sac', 'surgical intervention', 'incidence of adverse events', 'gestational sac spontaneously', 'rate of completion of missed miscarriage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}, {'cui': 'C0069304', 'cui_str': 'POU5F1 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0948766', 'cui_str': 'Ultrasound pelvis'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1126026', 'cui_str': 'Mifepristone 200 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}]",2595.0,0.70251,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Chu', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Devall', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. Electronic address: a.j.devall@bham.ac.uk.'}, {'ForeName': 'Leanne E', 'Initials': 'LE', 'LastName': 'Beeson', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'C Okeke', 'Initials': 'CO', 'LastName': 'Ogwulu', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Jones', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jenny H', 'Initials': 'JH', 'LastName': 'La Fontaine Papadopoulos', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bender-Atik', 'Affiliation': 'The Miscarriage Association, Wakefield, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's Charity, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Choudhary', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Naftalin', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nunes', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster NHS Foundation Trust, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': ""St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.""}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Izzat', 'Affiliation': 'University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kalsang', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Hassan', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Yadava', 'Initials': 'Y', 'LastName': 'Jeve', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': ""Guy's and St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ""Kings College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Watkins', 'Affiliation': ""Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Princess Royal Hospital, Shrewsbury and Telford NHS Trust, Telford, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Department of Reproductive Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Chitra S', 'Initials': 'CS', 'LastName': 'Kumar', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Small', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Pringle', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hodge', 'Affiliation': 'Singleton Hospital, Swansea Bay University Health Board, Swansea, UK.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Ioannis D', 'Initials': 'ID', 'LastName': 'Gallos', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick, UK.'}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31788-8']
2764,32853584,"Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial.","BACKGROUND


Patients with immune thrombocytopenia are at risk of bleeding during surgery, and intravenous immunoglobulin is commonly used to increase the platelet count. We aimed to establish whether perioperative eltrombopag was non-inferior to intravenous immunoglobulin.
METHODS


We did a randomised, open-label trial in eight academic hospitals in Canada. Patients were aged at least 18 years, with primary or secondary immune thrombocytopenia and platelet counts less than 100 × 10 9  cells per L before major surgery or less than 50 × 10 9  cells per L before minor surgery. Previous intravenous immunoglobulin within 2 weeks or thrombopoietin receptor agonists within 4 weeks before randomisation were not permitted. Patients were randomly assigned to receive oral daily eltrombopag 50 mg from 21 days preoperatively to postoperative day 7 or intravenous immunoglobulin 1 g/kg or 2 g/kg 7 days before surgery. Eltrombopag dose adjustments were allowed weekly based on platelet counts. The randomisation sequence was generated by a computerised random number generator, concealed and stratified by centre and surgery type (major or minor). The central study statistician was masked to treatment allocation. The primary outcome was achievement of perioperative platelet count targets (90 × 10 9  cells per L before major surgery or 45 × 10 9  cells per L before minor surgery) without rescue treatment. We did intention-to-treat and per-protocol analyses using an absolute non-inferiority margin of -10%. This trial is registered with ClinicalTrials.gov, NCT01621204.
FINDINGS


Between June 5, 2013, and March 7, 2019, 92 patients with immune thrombocytopenia were screened, of whom 74 (80%) were randomly assigned: 38 to eltrombopag and 36 to intravenous immunoglobulin. Median follow-up was 50 days (IQR 49-55). By intention-to-treat analysis, perioperative platelet targets were achieved for 30 (79%) of 38 patients assigned to eltrombopag and 22 (61%) of 36 patients assigned to intravenous immunoglobulin (absolute risk difference 17·8%, one-sided lower limit of the 95% CI 0·4%; p non-inferiority =0·005). In the per-protocol analysis, perioperative platelet targets were achieved for 29 (78%) of 37 patients in the eltrombopag group and 20 (63%) of 32 in the intravenous immunoglobulin group (absolute risk difference 15·9%, one-sided lower limit of the 95% CI -2·1%; p non-inferiority =0·009). Two serious adverse events occurred in the eltrombopag group: one treatment-related pulmonary embolism and one vertigo. Five serious adverse events occurred in the intravenous immunoglobulin group (atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy); all were related to complications of surgery. No treatment-related deaths occurred.
INTERPRETATION


Eltrombopag is an effective alternative to intravenous immunoglobulin for perioperative treatment of immune thrombocytopenia. However, treatment with eltrombopag might increase risk of thrombosis. The decision to choose one treatment over the other will depend on patient preference, resource limitations, cost, and individual risk profiles.
FUNDING


GlaxoSmithKline and Novartis.",2020,"Five serious adverse events occurred in the intravenous immunoglobulin group (atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy); all were related to complications of surgery.","['Patients with immune thrombocytopenia', 'eight academic hospitals in Canada', 'patients with immune thrombocytopenia', '92 patients with immune thrombocytopenia were screened, of whom 74 (80%) were randomly assigned: 38 to', 'Between June 5, 2013, and March 7, 2019', 'Patients were aged at least 18 years, with primary or secondary immune thrombocytopenia and platelet counts less than 100\u2008×\u200810 9  cells per L before major surgery or less than 50\u2008×\u200810 9  cells per L before minor surgery']","['oral daily eltrombopag', 'eltrombopag and 36 to intravenous immunoglobulin', 'Perioperative oral eltrombopag', 'intravenous immunoglobulin', 'immunoglobulin', 'Eltrombopag', 'eltrombopag', 'perioperative eltrombopag']","['atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy', 'achievement of perioperative platelet count targets', 'risk of thrombosis', 'adverse events', 'pulmonary embolism and one vertigo', 'perioperative platelet targets']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgical Procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0406670', 'cui_str': 'Vulvodynia'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}]",92.0,0.259546,"Five serious adverse events occurred in the intravenous immunoglobulin group (atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy); all were related to complications of surgery.","[{'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Arnold', 'Affiliation': 'Michael G DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada; Canadian Blood Services, Ancaster, ON, Canada. Electronic address: arnold@mcmaster.ca.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Heddle', 'Affiliation': 'Michael G DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Cook', 'Affiliation': 'Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Hsia', 'Affiliation': 'Department of Medicine, Division of Hematology, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Blostein', 'Affiliation': 'Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Jamula', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sholzberg', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Kassis', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Loree', 'Initials': 'L', 'LastName': 'Larratt', 'Affiliation': 'Division of Hematology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tinmouth', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Sufia', 'Initials': 'S', 'LastName': 'Amini', 'Affiliation': 'Department of Hematology, HagaZiekenhuis, The Hague, Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schipperus', 'Affiliation': 'Department of Hematology, HagaZiekenhuis, The Hague, Netherlands; Department of Hematology, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Vishnu', 'Affiliation': 'Division of Hematology, Mayo Clinic College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Warner', 'Affiliation': 'McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Carruthers', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Kelton', 'Affiliation': 'Michael G DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30227-1']
2765,32853740,Quality of life after ministernotomy versus full sternotomy aortic valve replacement.,"Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomized trials. The QUALITY-AVR trial is a single-blind, single-centre, independent, randomized clinical trial comparing ministernotomy to full sternotomy in patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement. One hundred patients were randomized in a 1:1 computational fashion. The primary end point was a difference between intervention groups of ≥ 0.10 points in change from baseline quality of life Questionnaire EuroQOL-index (EQ-5D-5L®), measured at 1, 6 or 12 months. Secondary endpoints were differences in change from other baseline EQ-5D-5L® utilities, cardiac surgery specific satisfaction questionnaire (SATISCORE®), a combined safety endpoint of four major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events and acute renal failure), bleeding through drains within the first 24 h, intubation time, and other minor endpoints. Clinical follow up was scheduled at baseline, 1, 6, and 12 months after randomization. Change from baseline mean difference EQ-5D-index was +0.20 points (95%CI 0.10-0.30, p<0.001) and median difference +0.14 (95%CI 0.06-0.22, p<0.001), favoring the ministernotomy group at 1 month. Patient satisfaction was also better at 1 month (Satiscore 83 ±9 vs 77± 13 points; p = 0,010). The ministernotomy group had significantly less bleeding in the first 24 hours (299 ± 140 vs 509 ± 251 ml, p=0.001). Ministernotomy provides a faster recovery with improved quality of life and satisfaction at 1 month compared to full sternotomy.",2020,"Patient satisfaction was also better at 1 month (Satiscore 83 ±9 vs 77± 13 points; p = 0,010).","['One hundred patients', 'patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement']","['ministernotomy', 'ministernotomy versus full sternotomy aortic valve replacement']","['Patient satisfaction', 'baseline quality of life Questionnaire EuroQOL-index (EQ-5D-5L®', 'EQ-5D-index', 'quality of life and satisfaction', 'Quality of life and patient satisfaction', 'Quality of life', 'baseline EQ-5D-5L® utilities, cardiac surgery specific satisfaction questionnaire (SATISCORE®), a combined safety endpoint of four major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events and acute renal failure), bleeding through drains within the first 24 h, intubation time, and other minor endpoints', 'bleeding']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",100.0,0.311003,"Patient satisfaction was also better at 1 month (Satiscore 83 ±9 vs 77± 13 points; p = 0,010).","[{'ForeName': 'Emiliano A', 'Initials': 'EA', 'LastName': 'Rodríguez-Caulo', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: erodriguezcaulo@hotmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Guijarro-Contreras', 'Affiliation': 'UGC Heart Area. Cardiology Department, Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Guzón', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Otero-Forero', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Mataró', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sánchez-Espín', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Villaescusa', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Melero-Tejedor', 'Affiliation': 'UGC Heart Area. Cardiovascular Surgery Dept., Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Jiménez-Navarro', 'Affiliation': 'UGC Heart Area. Cardiology Department, Hospital Universitario Virgen de la Victoria de Málaga, Spain. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga. Spain. CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.07.013']
2766,32853755,"Impact of Simulation-based Training and Neurofeedback Interventions on Radiation Technologists Workload, Situation Awareness, and Performance.","PURPOSE


To assess the effect of a combined intervention - simulation-based training supported by neurofeedback sessions - on radiation technologists (RTs') workload, situation awareness, and performance during routine quality assurance (QA) and treatment delivery tasks.
METHODS AND MATERIALS


As part of a prospective IRB-approved study, 32 RTs previously randomized to receive vs. not receive simulation-based training focused on patient safety were again randomized to receive vs. not receive a 3-week neurofeedback intervention (8 sessions of alpha-theta protocol) focused on stress reduction as well as conscious precision, strong focus, and ability to solve arising problems. Perceived workload was quantified using the NASA-Task Load Index (NASA-TLX). Situation awareness was quantified using the situation awareness rating technique (SART). Performance score was calculated using procedural compliance with time-out components and error detection.
RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance, when compared with other study groups (p < 0.01).
CONCLUSIONS


This finding is encouraging and provides basis for utilizing neurofeedback as means to possibly augment performance improvements gained during simulation-based training.",2020,"RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance, when compared with other study groups (p < 0.01).
",[],"['neurofeedback intervention (8 sessions of alpha-theta protocol', 'Simulation-based Training and Neurofeedback Interventions', 'combined intervention - simulation-based training']","['Radiation Technologists Workload, Situation Awareness, and Performance', 'perceived workload or situation awareness scores', ""radiation technologists (RTs') workload, situation awareness, and performance during routine quality assurance (QA"", 'Performance score', 'situation awareness rating technique (SART']",[],"[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0260280', 'cui_str': 'Technologist'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",32.0,0.017154,"RESULTS


RTs randomized to simulation-based training followed by neurofeedback sessions demonstrated no significant changes in perceived workload or situation awareness scores, but did have better performance, when compared with other study groups (p < 0.01).
","[{'ForeName': 'Lukasz M', 'Initials': 'LM', 'LastName': 'Mazur', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC; School of Information and Library Sciences, University of North Carolina at Chapel Hill, NC, USA; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, NC, USA. Electronic address: lmazur@med.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Prithima R', 'Initials': 'PR', 'LastName': 'Mosaly', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC; School of Information and Library Sciences, University of North Carolina at Chapel Hill, NC, USA; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nuamah', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Adapa', 'Affiliation': 'Carolina Health Informatics Program, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Lawrence B', 'Initials': 'LB', 'LastName': 'Marks', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC.'}]",Practical radiation oncology,['10.1016/j.prro.2020.08.005']
2767,32853783,Coffee consumption for recovery of intestinal function after laparoscopic gynecological surgery: a randomized controlled trial.,"BACKROUND


To investigate the effect of postoperative coffee consumption on bowel motility after laparoscopic gynecological surgery.
MATERIALS AND METHODS


In this randomized controlled trial, patients were allocated postoperatively to 3 cups of either coffee or warm water at 6, 12, or 18 h after the operation. Total hysterectomy and bilateral salpingectomy were performed on all patients. In addition, a salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy were performed according to clinical indications. The primary endpoint was time to the first passage of flatus after surgery.
RESULTS


A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water). The median time to flatus (19 [13-35] vs. 25 [15-42] h; hazard ratio [HR] 1.9, 95% confidence interval [CI], 1.2-2.9; P = 0.0009), median time to defecation (30 [22-54] vs. 38 [26-65] h, HR 2.4, 95% CI, 1.5-3.8; P < 0.0001), and mean time to tolerate food (2 [2-5] vs. 3 [2-8] days, HR 1.5, 95% CI, 1.02-2.3; P = 0.002) were decreased significantly in patients who consumed coffee compared with the control subjects. Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02). No adverse events were attributed to coffee consumption.
CONCLUSION


Postoperative coffee intake after laparoscopic gynecological surgery hastened the recovery of gastrointestinal function by reducing the time to the first passage of flatus, time to the first defecation, and time to tolerate a solid diet. This simple, cheap, and well-tolerated treatment merits routine use alongside other existing enhanced recovery pathways in the postoperative setting.",2020,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"['A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water', 'after laparoscopic gynecological surgery']","['salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy', 'Coffee consumption', 'postoperative coffee consumption']","['mean time to tolerate food', 'intestinal function', 'Total hysterectomy and bilateral salpingectomy', 'adverse events', 'bowel motility', 'time to the first passage of flatus after surgery', 'Postoperative ileus', 'recovery of gastrointestinal function', 'median time to flatus', 'median time to defecation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0036132', 'cui_str': 'Salpingo-oophorectomy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C0195509', 'cui_str': 'Bilateral complete salpingectomy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",96.0,0.115899,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Gungorduk', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey. Electronic address: drkemalgungorduk@gmail.com.'}, {'ForeName': 'Ezgi Karakas', 'Initials': 'EK', 'LastName': 'Paskal', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Demirayak', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sezen Bozkurt', 'Initials': 'SB', 'LastName': 'Köseoğlu', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Akbaba', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Isa Aykut', 'Initials': 'IA', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.016']
2768,32853821,Psychometric properties of the Asthma Symptom Index in patients with severe asthma.,"BACKGROUND


Evaluation of symptoms is essential in asthma clinical research. Daily symptom diaries require once- or twice-daily recording, making them less suited to real-world use. A modified version of the established Asthma Symptom Utility Index (ASUI) that includes symptom attributes (Asthma Symptom Index; ASI) was developed as a less-burdensome measure of asthma symptoms.
OBJECTIVE


To evaluate the ASI and replicate ASUI psychometric properties, including validity, reliability, responsiveness and minimal clinically important difference (MCID) estimation in patients ≥12 years of age with severe asthma.
METHODS


Patients from a randomized trial (MUSCA [n=497]) and a cross-sectional study (IDEAL [n=721]) were analyzed post-hoc. Demographic information, spirometry, ASI and ASUI scores, and other patient-reported outcome measures such as Asthma Control Questionnaire (ACQ-5) and St George's Respiratory Questionnaire (SGRQ) at baseline and during follow-up (MUSCA only) were obtained.
RESULTS


Internal consistency reliability and test-retest reliability were considered good (>0.70 [Cronbach's alpha] and 0.87-0.90 [intra-class correlation]). ASI/ASUI scores correlated strongly with ACQ-5 and SGRQ scores (spearman correlation [r s ] magnitude: 0.67-0.85). ASI and ASUI scores differed for asthma control (defined by ACQ-5) and lung function (% predicted forced expiratory volume in 1 second). Changes in ASI and ASUI score from baseline to Week 4 and Week 12 had high correlations with changes in ACQ-5 (r s  magnitude: 0.57-0.69). MCIDs ranged from -0.42 to -0.26 (ASI) and 0.07 to 0.11 (ASUI).
CONCLUSION


Findings show the good reliability, validity and responsiveness of the ASI, indicating potential value for real-world symptom assessment in severe asthma.",2020,ASUI scores correlated strongly with ACQ-5 and SGRQ scores (spearman correlation,"['patients with severe asthma', 'Patients from a randomized trial (MUSCA [n=497]) and a cross-sectional study (IDEAL [n=721', 'patients ≥12 years of age with severe asthma']",['ACQ-5'],"[""Demographic information, spirometry, ASI and ASUI scores, and other patient-reported outcome measures such as Asthma Control Questionnaire (ACQ-5) and St George's Respiratory Questionnaire (SGRQ"", 'Changes in ASI and ASUI score', 'lung function', 'Internal consistency reliability and test-retest reliability', 'ASI and ASUI scores', 'ACQ-5 and SGRQ scores (spearman correlation', 'ASUI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0323065', 'cui_str': 'Musca'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0328296,ASUI scores correlated strongly with ACQ-5 and SGRQ scores (spearman correlation,"[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Value Evidence and Outcomes, GSK, Collegeville, PA, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'von Maltzahn', 'Affiliation': 'Value Evidence and Outcomes, GSK, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nelsen', 'Affiliation': 'Value Evidence and Outcomes, GSK, Collegeville, PA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Revicki', 'Affiliation': 'Revicki Outcomes Research Consulting, Sarasota, FL, USA. Electronic address: dennis.revicki@gmail.com.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.019']
2769,32854206,Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results.,"BACKGROUND


the aim of this study was to assess the 2-year pulp survival of deep carious lesions in teeth excavated using a self-limiting protocol in a single-blind randomized controlled clinical trial.
METHODS


At baseline, 101 teeth with deep carious lesions in 86 patients were excavated randomly using self-limiting or control protocols. Standardized clinical examination and periapical radiographs of teeth were performed after 1- and 2-year follow-ups (REC 14/LO/0880).
RESULTS


During the 2-year period of the study, 24 teeth failed (16 and 8 at T12 and T24, respectively). Final analysis shows that 39/63 (61.9%) of teeth were deemed successful (16/33 (48.4%) and 23/30 (76.6%) in the control and experimental groups, respectively with a statistically significant difference (z score = 2.3,  p  = 0.021). Of teeth with severe and mild symptoms at T0, 42.9% and 36.7% respectively failed at T24 ( p  > 0.05). Within the self-limiting group, there was a lower success in premolars compared to molars ( p  < 0.05).
CONCLUSION


after 2 years, there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis. Molars showed higher success than premolars in teeth excavated using the self-limiting protocol. There was no statistically significant association between the outcome and the severity of symptoms at T0 (ClinicalTrials.gov NCT03071588).",2020,", there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis.","['101 teeth with deep carious lesions in 86 patients', 'patients with reversible pulpitis']",['Self-Limiting versus Rotary Subjective Carious Tissue Removal'],"['pulp survival rate', '2-year pulp survival']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",101.0,0.060801,", there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis.","[{'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Ali', 'Affiliation': 'Aesthetic and Restorative Dentistry Department, College of Dentistry, University of Baghdad, Baghdad 10001, Iraq.'}, {'ForeName': 'Farah Ben', 'Initials': 'FB', 'LastName': 'Thani', 'Affiliation': ""Department of Endodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 22 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Foschi', 'Affiliation': ""Department of Endodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 22 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}, {'ForeName': 'Avijit', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': ""Conservative & MI Dentistry, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 25 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mannocci', 'Affiliation': ""Department of Endodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London Floor 22 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}]",Journal of clinical medicine,['10.3390/jcm9092738']
2770,32854339,A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children.,"The popularity of multiparticulate formulations (MPs) as a paediatric dosage form continues to increase. MPs comprise of multiple small units that are easy-to-swallow. Currently, MPs are commonly manufactured into unit doses that are either swallowed whole or opened prior to administration. While this is an acceptable approach, dosing is envisioned to be optimised with a ""standard"" paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (Sympfiny TM , HS Design, Morristown, NJ, USA) that is being developed as a tool to dispense and administer MPs to children. Forty children, 4-12 years old, received 0.5, 1.2, and 2.0 mL doses of placebo MPs using the oral syringe with spring water or a drink of choice to complete sample intake. Acceptability was recorded as those able to completely swallow the dose and participants also rated dose acceptability on a 5-point scale. The ability to completely swallow the dose decreased as dose volume increased; the smallest dose was completely swallowed by 87.5% (35/40) children, and 69.4% (27/39) of children confirmed their willingness to take the sample as a daily medicine. Larger doses, 1.2 and 2.0 mL, gave values of 55% and 57.5% for the doses completely swallowed and 58.8% and 51.72% for willingness to take the sample as a daily medicine, respectively. Use of a drink of choice showed no increase in swallowability as compared with water. The novel oral syringe being developed is an appropriate device for dispensing doses flexibly and administering neutral tasting MPs directly to the mouth in the lower dose range without the need for a co-administration vehicle in children aged 4-12 years.",2020,Use of a drink of choice showed no increase in swallowability as compared with water.,"['children aged 4-12 years', 'Forty children, 4-12 years old, received 0.5, 1.2, and 2.0 mL doses of', 'Preschool and School Children']","['placebo MPs', 'novel oral syringe (Sympfiny TM , HS Design, Morristown, NJ, USA']","['swallowability', 'Acceptability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",40.0,0.0406445,Use of a drink of choice showed no increase in swallowability as compared with water.,"[{'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Katarzyna Hofmanová', 'Affiliation': 'School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Pfizer Global R&D, Sandwich, Kent CT13 9NJ, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Coupe', 'Affiliation': 'Pfizer Global R&D, Sandwich, Kent CT13 9NJ, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'A Bartlett', 'Affiliation': 'Pfizer Global R&D, Groton, CT 06340, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Monahan', 'Affiliation': 'Pfizer Global R&D, Groton, CT 06340, USA.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.'}]",Pharmaceutics,['10.3390/pharmaceutics12090806']
2771,32854375,Optimisation and Validation of a Nutritional Intervention to Enhance Sleep Quality and Quantity.,"BACKGROUND


Disturbed sleep may negatively influence physical health, cognitive performance, metabolism, and general wellbeing. Nutritional interventions represent a potential non-pharmacological means to increase sleep quality and quantity.
OBJECTIVE


(1) Identify an optimal suite of nutritional ingredients and (2) validate the effects of this suite utilising polysomnography, and cognitive and balance tests.
METHODS


The optimal and least optimal combinations of six ingredients were identified utilising 55 male participants and a Box-Behnken predictive model. To validate the model, 18 healthy, male, normal sleepers underwent three trials in a randomised, counterbalanced design: (1) optimal drink, (2) least optimal drink, or (3) placebo were provided before bed in a double-blinded manner. Polysomnography was utilised to measure sleep architecture. Cognitive performance, postural sway, and subjective sleep quality, were assessed 30 min after waking.
RESULTS


The optimal drink resulted in a significantly shorter sleep onset latency (9.9 ± 12.3 min) when compared to both the least optimal drink (26.1 ± 37.4 min) and the placebo drink (19.6 ± 32.0 min). No other measures of sleep, cognitive performance, postural sway, and subjective sleep quality were different between trials.
CONCLUSION


A combination of ingredients, optimised to enhance sleep, significantly reduced sleep onset latency. No detrimental effects on sleep architecture, subjective sleep quality or next day performance were observed.",2020,The optimal drink resulted in a significantly shorter sleep onset latency (9.9 ± 12.3 min) when compared to both the least optimal drink (26.1 ± 37.4 min) and the placebo drink (19.6 ± 32.0 min).,"['18 healthy, male, normal sleepers', '55 male participants and a Box-Behnken predictive model']","['optimal drink, (2) least optimal drink, or (3) placebo', 'placebo', 'Nutritional Intervention']","['shorter sleep onset latency', 'Sleep Quality and Quantity', 'sleep quality and quantity', 'sleep onset latency', 'Cognitive performance, postural sway, and subjective sleep quality', 'sleep, cognitive performance, postural sway, and subjective sleep quality', 'sleep architecture, subjective sleep quality or next day performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",55.0,0.0736757,The optimal drink resulted in a significantly shorter sleep onset latency (9.9 ± 12.3 min) when compared to both the least optimal drink (26.1 ± 37.4 min) and the placebo drink (19.6 ± 32.0 min).,"[{'ForeName': 'Shona L', 'Initials': 'SL', 'LastName': 'Halson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Banyo QLD 4014, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Shaw', 'Affiliation': 'High Performance Unit, Swimming Australia, Brisbane QLD 4519, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Versey', 'Affiliation': 'Rowing Australia, Yarralumla ACT 2600, Australia.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Miller', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Wayville 5034, Australia.'}, {'ForeName': 'Charli', 'Initials': 'C', 'LastName': 'Sargent', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Wayville 5034, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Wayville 5034, Australia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Nyman', 'Affiliation': 'Gatorade Sport Science Institute, PepsiCo Global Research and Development-Life Sciences, Purchase, NY 10577, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Carter', 'Affiliation': 'Gatorade Sport Science Institute, PepsiCo Global Research and Development-Life Sciences, Purchase, NY 10577, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Baar', 'Affiliation': 'Departments of Neurobiology, Physiology & Behavior and Department of Physiology and Membrane Biology, University of California Davis School of Medicine, Davis, CA 95817, USA.'}]",Nutrients,['10.3390/nu12092579']
2772,32854478,[Regulatory relationship between lncRNA KCNQ1OT1 and miR-146a-3p in preeclampsia].,"Objective:  To observe the changes of the expression level of long non-coding RNA (lncRNA) KCNQ1OT1 and microRNA (miR)-146a-3p in placenta tissues of preeclampsia (PE) patients, as well as their effect and mechanism on the biological functions of trophoblast cells.  Methods:  A total of 45 cases of hospitalized PE patients in Hainan General Hospital from July 2017 to July 2018 were selected as the PE group, 55 normal pregnant women during the same period were chosed as the control group. The expression level of KCNQ1OT1 mRNA and miR-146a-3p in the placenta tissues between two groups were detected by using quantitative real time (qRT)-PCR. Pearson's test was furtherly analyzed the correlation between them. Human trophoblast cell line (HTR8/SVneo) were randomly divided into control and lipopolysaccharide (LPS) groups, and then LPS group were divide into four sub-groups,included LPS group, short hairpin RNA (sh)-KCNQ1OT1 (after silencing the expression of KCNQ1OT1), miR-146a-3p inhibitor and sh-KCNQ1OT1+miR-146a-3p inhibitor. The targeting relationship between KCNQ1OT1 and miR-146a-3p were predicted by bioinformatics software and confirmed by luciferase assay. The cell proliferation and invasion capacities were respectively detected by cell counting kit-8 (CCK-8) and transwell assay. The expression level of KCNQ1OT1 mRNA and miR-146a-3p were detected by qRT-PCR and the protein expression level of CXC chemokine ligand 12 （CXCL12） and CXC chemokine receptor type 4 (CXCR4) were tested by western blot.  Results:  (1) The mRNA expression level of KCNQ1OT1 in the placenta of PE group was lower than that of control group (0.23±0.03 vs 0.51±0.04,  P <0.05), and the miR-146a-3p expression level was higher than that of the control group (0.49±0.03 vs 0.31±0.03,  P <0.05), there were statistical significant differences between the two groups. (2) Luciferase assay showed that there was a targeting relationship between KCNQ1OT1 and mir-146a-3p. Compared with the control group, the mRNA expression level of KCNQ1OT1 in the LPS group were significantly decreased (0.91±0.03 vs 0.35±0.03,  P <0.05), and the expression level of miR-146a-3p were significantly increased (0.22±0.03 vs 0.63±0.04,  P <0.05). The cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 significantly reduced in the LPS group compared with control group (all  P <0.05). The mRNA expression level of KCNQ1OT1 (0.23±0.03) in the sh-KCNQ1OT1 group were further decreased, the expression of miR-146a-3p (0.85±0.03) were further increased, and the cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 were all further reduced compared with control group，there were significant difference between two groups (all  P <0.05). Comparing the miR-146a-3p inhibitor group, and sh-KCNQ1OT1+miR-146a-3p inhibitor group with the sh-KCNQ1OT1 group, respectively, the expression level of KCNQ1OT1 mRNA (0.78±0.04 vs 0.50±0.03) increased, and the expression level of miR-146a-3p (0.42±0.03 vs 0.46±0.03) decreased, the cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 were all increased ,there were statistically significant differences (all  P <0.05).  Conclusion:  KCNQ1OT1 could target the regulation of miR-146a-3p through CXCL12/CXCR4 pathway in the proliferation, invasion an migration of HTR8/SVneo cells, which may be involved in the pathogenesis of PE.",2020,"The cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 significantly reduced in the LPS group compared with control group (all  P <0.05).","['45 cases of hospitalized PE patients in Hainan General Hospital from July 2017 to July 2018 were selected as the PE group, 55 normal pregnant women during the same period were chosed as the control group', 'preeclampsia']","['LPS group, short hairpin RNA (sh)-KCNQ1OT1 (after silencing the expression of KCNQ1OT1), miR-146a-3p inhibitor and sh-KCNQ1OT1+miR-146a-3p inhibitor', 'lipopolysaccharide (LPS', 'miR-146a-3p inhibitor group, and sh-KCNQ1OT1+miR-146a-3p inhibitor', 'Human trophoblast cell line (HTR8/SVneo']","['expression level of long non-coding RNA (lncRNA) KCNQ1OT1 and microRNA', 'cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4', 'expression of miR-146a-3p', 'cell proliferation and invasion capacities', 'miR-146a-3p expression level', 'expression level of KCNQ1OT1 mRNA', 'expression level of KCNQ1OT1 mRNA and miR-146a-3p in the placenta tissues', 'mRNA expression level of KCNQ1OT1', 'expression level of miR-146a-3p', 'expression level of KCNQ1OT1 mRNA and miR-146a-3p']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445505', 'cui_str': 'Hainan'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2930586', 'cui_str': 'shRNA'}, {'cui': 'C1436653', 'cui_str': 'KCNQ1OT1 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041178', 'cui_str': 'Trophoblast structure'}, {'cui': 'C0007600', 'cui_str': 'Cell Line'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1436653', 'cui_str': 'KCNQ1OT1 protein, human'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",55.0,0.0163295,"The cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 significantly reduced in the LPS group compared with control group (all  P <0.05).","[{'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cen', 'Affiliation': ''}, {'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Chen', 'Affiliation': ''}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200322-00246']
2773,32854485,Effectiveness of Exercise on the Sequence Effect in Parkinson's Disease.,"Objective


To determine the benefits of motor training on the sequence effect (SE), an essential component of bradykinesia in Parkinson's disease (PD).
Methods


Seven patients with de novo PD participated in this study. The patients performed regular pentagon drawing tests and exercises during four visits. The first two visits occurred before the start of medication, and the last two visits occurred at least six months after the start of medication. We assessed the severity of bradykinesia and SE at each visit and compared the results before and after exercise in both the de novo and treatment conditions.
Results


In the de novo condition, the severity of bradykinesia significantly improved after motor training (p = 0.018), but it did not resolve and only showed a trend of improvement after treatment (p = 0.068). The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
Conclusion


Our study suggests that regular motor training may be beneficial for the SE in PD.",2020,"The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
","[""Parkinson's disease (PD"", ""Parkinson's Disease"", 'Seven patients with de novo PD participated in this study']","['motor training', 'Exercise', 'regular motor training']","['severity of bradykinesia and SE', 'severity of the SE', 'severity of bradykinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",7.0,0.017575,"The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
","[{'ForeName': 'Suk Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of movement disorders,['10.14802/jmd.20045']
2774,31707982,Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials.,"BACKGROUND


The ACR20 has been validated as the best discriminator of efficacy in placebo-controlled trials, but not in head-to-head trials comparing effective therapies in patients with rheumatoid arthritis (RA). We assessed the most discriminatory ACR response and most discriminatory percent improvement in disease activity measures for Simplified Disease Activity index (SDAI), Clinical Disease Activity index (CDAI), and 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)) using different patient populations and trial designs.
METHODS


Data from two placebo-controlled studies in established RA and two head-to-head studies in early RA were analyzed. The numeric ACR response for each treatment and P value for the difference between treatments were calculated at multiple time points to determine the ACR response associated with the lowest P value. Similarly, values for percent improvement from baseline in SDAI, CDAI, and DAS28(CRP) with the most discrimination between treatments were examined.
RESULTS


In the head-to-head early RA trials, the minimum P value and greatest treatment difference between the active comparator arms at 6 months was achieved at higher ACR rates and greater percent improvements in other disease activity measures. In established RA, lower responses (minimum P value and maximum treatment difference) and smaller improvements in disease activity scores had better discriminatory ability at 6 months.
CONCLUSIONS


The most discriminatory ACR response rate and percent improvement in disease activity measures were higher in head-to-head active comparator trials in early RA versus placebo-controlled trials in established RA. This difference should be considered in future clinical trial designs.
TRIAL REGISTRATION


NCT00195663, NCT00420927, NCT00195702.",2019,The most discriminatory ACR response rate and percent improvement in disease activity measures were higher in head-to-head active comparator trials in early RA versus placebo-controlled trials in established RA.,"['patients with rheumatoid arthritis (RA', 'Data from two placebo-controlled studies in established RA and two head-to-head studies in early RA']",['placebo'],"['disease activity measures for Simplified Disease Activity index (SDAI), Clinical Disease Activity index (CDAI), and 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP', 'numeric ACR response', 'disease activity scores', 'disease activity measures', 'SDAI, CDAI, and DAS28(CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",,0.307324,The most discriminatory ACR response rate and percent improvement in disease activity measures were higher in head-to-head active comparator trials in early RA versus placebo-controlled trials in established RA.,"[{'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology Department of Internal Medicine 3, Medical University of Vienna and Hietzing Hospital, Waehringer Guertel 18-20, A-1090, Vienna, Austria. josef.smolen@meduniwien.ac.at.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aletaha', 'Affiliation': 'Division of Rheumatology Department of Internal Medicine 3, Medical University of Vienna and Hietzing Hospital, Waehringer Guertel 18-20, A-1090, Vienna, Austria.'}, {'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Yijie', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Sainsbury', 'Affiliation': 'AbbVie Ltd, Cambridge, UK.'}, {'ForeName': 'Ivan Lagunes', 'Initials': 'IL', 'LastName': 'Galindo', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}]",Arthritis research & therapy,['10.1186/s13075-019-2005-9']
2775,32857056,Technology-Assisted Self-Monitoring of Lifestyle Behaviors and Health Indicators in Diabetes: Qualitative Study.,"BACKGROUND


Self-monitoring is key to successful behavior change in diabetes and obesity, and the use of traditional paper-based methods of self-monitoring may be time-consuming and burdensome.
OBJECTIVE


This study aimed to explore participant experiences while using technology-assisted self-monitoring of lifestyle behaviors and health indicators among overweight or obese adults with type 2 diabetes.
METHODS


Qualitative data collected from the intervention group of a 6-month, three-arm (control, paper diary, and technology-assisted self-monitoring groups) randomized clinical trial were analyzed. Study participants in the intervention group monitored their diet, exercise, and weight using the LoseIt! app, and their blood glucose levels using a glucometer and the Diabetes Connect app. Semistructured group discussions were conducted at 6 weeks (n=10) from the initiation of the behavioral lifestyle intervention and again at 6 months (n=9). All group interviews were audiotaped and transcribed verbatim. Using a combination of thematic and comparative analysis approaches, two trained professionals coded the transcriptions independently and then discussed and concluded common themes for the 6-week and 6-month discussions separately.
RESULTS


The sample (n=10), which primarily involved African American participants (n=7) and female participants (n=8), had a mean age of 59.4 years. The following eight themes emerged: (1) perceived benefits of technology-assisted self-monitoring; (2) perceived ease of use (eg, barriers: technical difficulties and lack of self-discipline; facilitators: help from family, friends, and the program); (3) use of technology-assisted self-monitoring; (4) facilitators of engaging in healthy lifestyle behaviors (eg, visualization and awareness of calorie input/expenditure); (5) positive lifestyle change; (6) barriers of engaging in healthy lifestyle behaviors (eg, event influence); (7) learning curve; and (8) monitored data sharing. The first six of these themes were shared between the 6-week and 6-month timepoints, but the codes within these themes were not all the same and differed slightly between the two timepoints. These differences provide insights into the evolution of participant thoughts and perceptions on using technology for self-monitoring and subsequent behavioral lifestyle changes while participating in lifestyle interventions. The findings from the 6-week and 6-month data helped to paint a picture of participant comfort and the integration of technology and knowledge overtime, and clarified participant attitudes, difficulties, behavioral processes, and modifications, as well as health indicators that were experienced throughout the study.
CONCLUSIONS


Although there were some barriers, participants were able to identify various individual and external facilitators to adjust to and engage in technology-assisted self-monitoring, and it was concluded that the technology-assisted self-monitoring approach was beneficial, safe, and feasible to use for positive lifestyle change. These patient perspectives need to be considered in future research studies when investigating the effectiveness of using technology-assisted self-monitoring, as well as in clinical practice when recommending technology-assisted self-monitoring of lifestyle behaviors and health indicators to improve health outcomes.",2020,"Although there were some barriers, participants were able to identify various individual and external facilitators to adjust to and engage in technology-assisted self-monitoring, and it was concluded that the technology-assisted self-monitoring approach was beneficial, safe, and feasible to use for positive lifestyle change.","['overweight or obese adults with type 2 diabetes', 'Diabetes', 'The sample (n=10), which primarily involved African American participants (n=7) and female participants (n=8), had a mean age of 59.4 years']","['diet, exercise, and weight using the LoseIt', 'behavioral lifestyle intervention', 'technology-assisted self-monitoring of lifestyle behaviors', 'technology-assisted self-monitoring; (2) perceived ease of use (eg, barriers: technical difficulties and lack of self-discipline; facilitators: help from family, friends, and the program); (3) use of technology-assisted self-monitoring; (4) facilitators of engaging in healthy lifestyle behaviors (eg, visualization and awareness of calorie input/expenditure); (5) positive lifestyle change; (6) barriers of engaging in healthy lifestyle behaviors (eg, event influence); (7) learning curve; and (8) monitored data sharing']",['blood glucose levels'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C2713450', 'cui_str': 'Data Sharing'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",,0.018114,"Although there were some barriers, participants were able to identify various individual and external facilitators to adjust to and engage in technology-assisted self-monitoring, and it was concluded that the technology-assisted self-monitoring approach was beneficial, safe, and feasible to use for positive lifestyle change.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Dennis', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Shanae Lakel', 'Initials': 'SL', 'LastName': 'Rhodes', 'Affiliation': 'School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sia', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jisook', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Rozmin', 'Initials': 'R', 'LastName': 'Jiwani', 'Affiliation': 'School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}]",JMIR diabetes,['10.2196/21183']
2776,32857254,"Effectiveness of Cessation Messages Targeting Pregnant and Nonpregnant Female Smokers in the United States: A Cross-Sectional Analysis into the Impact of Pregnancy, Self-Efficacy, and Risk Perception.","OBJECTIVES


Roughly 10% of pregnant women are current smokers. Improving smoking cessation in this population before and during pregnancy is essential to prevent adverse fetal outcomes. This study aimed to examine cessation messages targeting American women.
METHODS


An obstetrics-gynecological clinic-based sample of female, current smokers of reproductive age (18-44 years old) was recruited (n = 135) from January to May 2019; half (51.2%) were currently pregnant. Participants completed a within-subjects study with a randomized set of gain- and loss-framed text-only pregnancy-related cessation messages (5 each). Each individual message was rated on a validated, 10-point scale for perceived effectiveness; responses to the seven items were averaged. Regression analyses examined differences in effectiveness ratings by message framing.
RESULTS


Study participants (female smokers) rated the gain-framed messages as slightly more effective than loss-framed messages (7.9 versus 7.7, p < 0.01). After adjusting for quit intention and pregnancy, the relationship between gain- and loss-framing and effectiveness ratings was modified by both self-efficacy and risk perceptions. Women who perceived high risks of smoking during pregnancy had higher effectiveness ratings of both gain- and loss-framed cessation messages, compared to women who perceived low risks. Lower cessation self-efficacy was significantly associated with lower effectiveness ratings for gain- and loss-framed messages (1.53 and 1.92, respectively; p < 0.05).
CONCLUSIONS FOR PRACTICE


Women with lower self-efficacy and low risk perception of smoking risks had the lowered effectiveness ratings for both frames of cessation messages. Enhancing self-efficacy and risk perceptions through clinical interventions may improve the effectiveness of targeted messages to promote quitting smoking before or during pregnancy.",2020,"Women who perceived high risks of smoking during pregnancy had higher effectiveness ratings of both gain- and loss-framed cessation messages, compared to women who perceived low risks.","['An obstetrics-gynecological clinic-based sample of female, current smokers of reproductive age (18-44\xa0years old) was recruited (n\u2009=\u2009135) from January to May 2019; half (51.2%) were currently pregnant', 'pregnant women are current smokers', 'Pregnant and Nonpregnant Female Smokers in the United States', 'American women']",['gain- and loss-framed text-only pregnancy-related cessation messages'],"['effectiveness ratings', 'Pregnancy, Self-Efficacy, and Risk Perception', 'Lower cessation self-efficacy', 'effectiveness ratings for gain- and loss-framed messages']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]",,0.0616887,"Women who perceived high risks of smoking during pregnancy had higher effectiveness ratings of both gain- and loss-framed cessation messages, compared to women who perceived low risks.","[{'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Busho', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Macisco', 'Affiliation': 'The Ohio State University College of Public Health, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Austin G', 'Initials': 'AG', 'LastName': 'Oslock', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Worly', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Klein', 'Affiliation': 'The Ohio State University College of Public Health, The Ohio State University, Columbus, OH, USA. Klein.232@osu.edu.'}]",Maternal and child health journal,['10.1007/s10995-020-03001-6']
2777,32857301,Comparing outcomes of hospitalized patients with moderate and severe COVID-19 following treatment with hydroxychloroquine plus atazanavir/ritonavir.,"BACKGROUND


The role of the antiviral therapy in treatment of COVID-19 is still a matter to be investigated. Also efficacy and safety of antiviral regimens were not compared according severity of the disease. In this study the efficacy and safety of hydroxychloroquine plus atazanavir/ritonavir was compared in patients with moderate and severe COVID-19.
METHODS


We prospectively evaluated the clinical outcomes of 213 patients with COVID-19 during the hospitalization course and up to 56 days after the hospital discharge. The disease was categorized to moderate and severe based on the severity of pneumonia and peripheral oxygen saturation (SpO2). The patients received the national treatment protocol containing hydroxychloroquine (400 mg BD in first day and then 200 mg BD) plus atazanavir/ritonavir (300/100 mg daily) for 7 days. Main outcomes included discharge rates at day 7, 14 and 28, 28-day mortality, rate of intensive care unit (ICU) admission and intubation, length of hospital and ICU stay and incidence of adverse events.
RESULTS


The mean (SD) age of patients was 60(14) years and 53% were male. According to WHO definition, 51.64% and 48.36% of the patients had moderate (SpO2 ≥ 90%) and severe disease (SpO2 < 90%) at baseline, respectively. The discharge rate of the moderate group was significantly higher than the severe group at day 7, 14 and 28 (HR = 0.49; 95% CI: 0.35-0.69, p = < 0.001 at day 7, HR = 0.48; 95% CI: 0.35-0.66, p = < 0.001 at day 14 and HR = 0.49; 95% CI: 0.36-0.67, p = < 0.001at day 28). The 28-day mortality of the severe group was six times higher than the moderate group (HR = 6.00; 95% CI: 2.50-14.44), p = < 0.001). The need of admission in ICU for the severe group and the moderate group was 37.86% and 18.18% of the patients. Length of hospital stay was significantly shorter in the moderate group in comparison with the severe group (5 ± 4 vs. 8 ± 6 days, p < 0.001). Patients in the moderate group experienced the serious adverse events and complications less than the severe group. The discharged patients were followed up to 56 days after discharge. Some of the patients complained of symptoms such as exertional dyspnea, weakness and new-onset hair loss.
CONCLUSION


Our study did not support the use of hydroxychloroquine plus atazanavir/ritonavir in patients who had SpO 2  < 90% at the time of hospital admission. SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.",2020,"SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.","['hospitalized patients with moderate and severe COVID-19 following treatment with', 'The mean (SD) age of patients was 60(14) years and 53% were male', 'patients who had SpO 2 \u2009<\u200990% at the time of hospital admission', 'patients with moderate and severe COVID-19', '213 patients with COVID-19 during the hospitalization course and up to 56\xa0days after the hospital discharge']","['hydroxychloroquine', 'atazanavir/ritonavir', 'hydroxychloroquine plus atazanavir/ritonavir']","['serious adverse events and complications', 'discharge rate', 'efficacy and safety', 'Length of hospital stay', '28-day mortality', 'exertional dyspnea, weakness and new-onset hair loss', 'clinical outcomes (duration of hospital stay, discharge from the hospital and mortality', 'discharge rates at day 7, 14 and 28, 28-day mortality, rate of intensive care unit (ICU) admission and intubation, length of hospital and ICU stay and incidence of adverse events', 'severity of pneumonia and peripheral oxygen saturation (SpO2', 'severe disease']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",213.0,0.133007,"SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Nourian', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nabiee', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Setayesh', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. khalilih@tums.ac.ir.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Abbasian', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghiasvand', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Seifi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hasannezhad', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ghaderkhani', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, Imam Khomeini Hospital Complex, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public health, Tehran University of Medical Sciences, Tehran, Iran.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00369-2']
2778,32857315,"Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study.","INTRODUCTION


The aims of this study were to characterize the single-dose pharmacokinetics (PK) of the major active metabolites of ozanimod, CC112273 and CC1084037, and to evaluate the effect of gemfibrozil (a strong inhibitor of cytochrome P450 [CYP] 2C8), itraconazole (a strong inhibitor of CYP3A and P-glycoprotein [P-gp]), and rifampin (a strong inducer of CYP3A/P-gp and moderate inducer of CYP2C8) on the single-dose PK of ozanimod and its major active metabolites in healthy subjects.
METHODS


This was a phase 1, randomized, parallel-group, open-label study with two parts. In part 1, 40 subjects were randomized to receive a single oral dose of ozanimod 0.46 mg (group A, n = 20) or oral doses of gemfibrozil 600 mg twice daily for 17 days with a single oral dose of ozanimod 0.46 mg on day 4 (group B, n = 20). In part 2, 60 subjects were randomized to receive a single oral dose of ozanimod 0.92 mg (group C, n = 20), oral doses of itraconazole 200 mg once daily for 17 days with a single oral dose of ozanimod 0.92 mg on day 4 (group D, n = 20), or oral doses of rifampin 600 mg once daily for 21 days with a single oral dose of ozanimod 0.92 mg on day 8 (group E, n = 20). Plasma PK parameters for ozanimod, CC112273, and CC1084037 were estimated using noncompartmental methods.
RESULTS


Dose-proportional increases in maximum observed concentration (C max ) and area under the concentration-time curve (AUC) were observed for ozanimod, CC112273, and CC1084037. The mean terminal elimination half-life (t 1/2 ) for ozanimod was approximately 20-22 h while the mean t 1/2  for CC112273 and CC1084037 were approximately 10 days. CC112273 and CC1084037 exposures were highly correlated with or without interacting drugs. Itraconazole increased ozanimod AUC by approximately 13% while rifampin reduced ozanimod AUC by approximately 24%, suggesting a minor role of CYP3A and P-gp in the overall disposition of ozanimod. Gemfibrozil increased the AUC for CC112273 and CC1084037 by approximately 47% and 69%, respectively. Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
CONCLUSIONS


Ozanimod's major active metabolites, CC112273 and CC1084037, exhibited similar single-dose PK properties and their exposures were highly correlated. CYP2C8 is one of the important enzymes in the overall disposition of CC112273 and subsequently its direct metabolite CC1084037.
TRIAL REGISTRATION


Clinical trial: NCT03624959.",2020,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
","['In part\xa02, 60 subjects', '40 subjects', 'healthy subjects', 'Healthy Subjects']","['itraconazole', 'ozanimod 0.46\xa0mg (group\xa0A, n\u2009=\u200920) or oral doses of gemfibrozil 600\xa0mg twice daily for 17\xa0days with a single oral dose of ozanimod 0.46\xa0mg on day\xa04', 'Ozanimod', 'Itraconazole', 'ozanimod', 'gemfibrozil', 'rifampin 600\xa0mg once daily for 21\xa0days with a single oral dose of ozanimod 0.92', 'Gemfibrozil', 'Gemfibrozil, Itraconazole, or Rifampin', 'ozanimod 0.92']","['Plasma PK parameters', 'ozanimod AUC', 'maximum observed concentration (C max ) and area under the concentration-time curve (AUC', 'mean terminal elimination half-life', 'AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C4517460', 'cui_str': '0.46'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0993358', 'cui_str': 'Gemfibrozil 600 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017245', 'cui_str': 'Gemfibrozil'}, {'cui': 'C1104996', 'cui_str': 'Rifampin 600 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517485', 'cui_str': '0.92'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",40.0,0.103499,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
","[{'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA. dr.jtran@gmail.com.'}, {'ForeName': 'Peijin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Liangang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Syto', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Nonclinical Research and Development, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01473-0']
2779,32857329,"Early Discontinuation versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients with Febrile Neutropenia, Before Recovery of Counts: A Randomized Controlled Trial (DALFEN Study)-Correspondence.",,2020,,"['Low Risk Pediatric Cancer Patients with Febrile Neutropenia, Before Recovery of Counts']",['Antimicrobial Therapy'],[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0439157', 'cui_str': 'counts'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.127697,,"[{'ForeName': 'Indar Kumar', 'Initials': 'IK', 'LastName': 'Sharawat', 'Affiliation': 'Division of Pediatric Neurology and Child Development, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Prateek Kumar', 'Initials': 'PK', 'LastName': 'Panda', 'Affiliation': 'Division of Pediatric Neurology and Child Development, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India. drprateekpanda@gmail.com.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03461-2']
2780,32857331,Seven versus Ten Days Antibiotics Course for Acute Pyogenic Meningitis in Children: A Randomized Controlled Trial.,"OBJECTIVES


To compare the efficacy and safety of 7 d vs. 10 d empirical antibiotic therapy in cases of acute pyogenic meningitis in children aged 3 mo to 14 y with rapid initial recovery.
METHODS


A total of 96 children aged 3 mo to 14 y with acute pyogenic meningitis were randomized to either 7 d or 10 d therapy on Day 5 of the therapy, if they were in clinical remission and had improving cerebrospinal fluid (CSF) abnormalities. The primary outcome was treatment failure in each group within 10 d of enrolment or relapse of meningitis defined as recurrence of signs and symptoms of meningitis within 2 wk of discharge. Secondary outcome was the presence of sequelae in patient at 30 d and 90 d follow-up post discharge.
RESULTS


Out of 111 screened children, 96 patients completed the trial, 48 in each group. There were 7 treatment failures and relapses each in the group receiving 7 d antibiotics while 6 failures and relapses each were seen in 10 d antibiotics group. There was no statistically significant difference in treatment failure in both the groups [2.1 (-0.12-0.16); p = 0.76]. No deaths or significant adverse effects of the drugs occurred during this study. Four cases of nosocomial sepsis were reported with 2 cases in each group. On subsequent 30 d and 90 d follow-up, no statistically significant difference was found between the two groups regarding frequency of hearing impairment, frequency of hydrocephalus [-2.1 (-0.09-0.13); p = 0.65] and various neurological sequelae [6.2 (-0.06-0.19); p > 0.05].
CONCLUSIONS


Short course antibiotic therapy may be adequately effective for treatment of acute pyogenic meningitis beyond neonatal age in children with initial rapid recovery.",2020,"On subsequent 30 d and 90 d follow-up, no statistically significant difference was found between the two groups regarding frequency of hearing impairment, frequency of hydrocephalus [-2.1 (-0.09-0.13); p = 0.65] and various neurological sequelae [6.2 (-0.06-0.19); p > 0.05].
","['Acute Pyogenic Meningitis in Children', '96 children aged 3 mo to 14 y with acute pyogenic meningitis', '111 screened children, 96 patients completed the trial, 48 in each group', 'cases of acute pyogenic meningitis in children aged 3 mo to 14 y with rapid initial recovery']",['antibiotic therapy'],"['treatment failure in each group within 10 d of enrolment or relapse of meningitis defined as recurrence of signs and symptoms of meningitis', 'treatment failure', 'efficacy and safety', 'frequency of hearing impairment, frequency of hydrocephalus', 'various neurological sequelae', 'cerebrospinal fluid (CSF) abnormalities', 'presence of sequelae in patient at 30 d and 90 d follow-up post discharge', 'nosocomial sepsis']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephalus'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",111.0,0.246943,"On subsequent 30 d and 90 d follow-up, no statistically significant difference was found between the two groups regarding frequency of hearing impairment, frequency of hydrocephalus [-2.1 (-0.09-0.13); p = 0.65] and various neurological sequelae [6.2 (-0.06-0.19); p > 0.05].
","[{'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Vaswani', 'Affiliation': 'Department of Pediatrics, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Nishu', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, PGIMS, Rohtak, Haryana, India. nishigupta.medico@gmail.com.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Department of Pediatrics, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Nadda', 'Affiliation': 'Department of Community Medicine, PGIMS, Rohtak, Haryana, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03454-1']
2781,32857445,Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial.,"BACKGROUND AND AIMS


Level of adherence to tobacco cessation medication regimens is believed to be causally related to medication effectiveness. This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment.
DESIGN


Multicenter, parallel-group two-arm randomized controlled trial.
SETTING


Urban opioid treatment program (OTP) in the Bronx, New York, USA.
PARTICIPANTS


Daily smokers of ≥5 cigarettes/day, interested in quitting (ladder of change score 6-8), in methadone treatment for ≥3 months, attending OTP ≥3 days/week. Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day.
INTERVENTIONS


Individual, block, random assignment to 12 weeks of varenicline, either directly observed with methadone (DOT, n=50) or via unsupervised self-administration (SAT, n=50).
MEASUREMENTS


The primary outcome was adherence measured by pill count. The secondary outcome was 7-day point prevalence tobacco abstinence verified by expired CO<8 parts per million.
FINDINGS


Retention at 24 weeks was 92%. Mean adherence was 78.5% (95% confidence interval (CI) 71.8-85.2%) in the DOT group versus 61.8% in the SAT group (95% CI 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks. CO-verified abstinence did not differ between groups during the intervention (p=0.26), but was higher in the DOT than the SAT group at intervention end (DOT 18% versus SAT 10%, difference 8%, 95% CI -13, 28); this difference was not significant (p=0.39) and was not sustained at 24-week follow up.
CONCLUSIONS


Among daily smokers attending opioid treatment programs, opioid treatment program-based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self-administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco abstinence.",2020,Mean adherence was 78.5% (95% confidence interval (CI) 71.8-85.2%) in the DOT group versus 61.8% in the SAT group (95% CI 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks.,"['methadone-maintained smokers', 'smokers with opioid use disorder (OUD) receiving methadone treatment', 'Urban opioid treatment program (OTP) in the Bronx, New York, USA.\nPARTICIPANTS\n\n\nDaily smokers of ≥5 cigarettes/day', ""Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day""]","['varenicline', 'varenicline self-administered therapy', 'varenicline, either directly observed with methadone (DOT, n=50) or via unsupervised self-administration (SAT, n=50', 'varenicline directly observed therapy (DOT']","['varenicline adherence', '7-day point prevalence tobacco abstinence verified by expired CO<8 parts per million', 'Mean adherence', 'CO-verified abstinence', 'tobacco abstinence', 'adherence measured by pill count', 'varenicline adherence and smoking cessation rates', 'varenicline adherence and smoking cessation']","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.219717,Mean adherence was 78.5% (95% confidence interval (CI) 71.8-85.2%) in the DOT group versus 61.8% in the SAT group (95% CI 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks.,"[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Nahvi', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, 111 East 210th Street, Bronx, NY.'}, {'ForeName': 'Tangeria R', 'Initials': 'TR', 'LastName': 'Adams', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, 111 East 210th Street, Bronx, NY.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, 111 East 210th Street, Bronx, NY.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, 111 East 210th Street, Bronx, NY.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, 111 East 210th Street, Bronx, NY.'}]","Addiction (Abingdon, England)",['10.1111/add.15240']
2782,32857471,"Efficacy and tolerability of low-dose spironolactone and topical benzoyl peroxide in adult female acne: A randomized, double-blind, placebo-controlled trial.","Effective therapies for adult female acne (AFA) are limited. Oral spironolactone (SPL), 100-200 mg/day, is currently used off-label to treat AFA. However, high-dose SPL results in clinically significant side-effects which prevent widespread use in clinical practice. The efficacy of low-dose spironolactone in AFA is unknown. We examined the efficacy and tolerability of low-dose (25-50 mg/day) oral SPL in Thai women with moderate AFA. A randomized, double-blind, placebo-controlled trial was conducted for 12 weeks. Moderate AFA patients aged between 25 and 45 years received a combination of daily topical benzoyl peroxide (BP) 2.5% plus either SPL 25 mg (SPL25 group), SPL 50 mg (SPL50 group) or placebo. We performed total acne counts and Adult Female Acne Scoring Tool (AFAST) grading at 4-week intervals. The success rate, defined as the proportion of participants achieving a ""clear/almost clear"" AFAST grade by the end of week 12, was considered as the main outcome. Treatment-related adverse events (TRAE) were recorded. We enrolled 63 participants in the study. The total acne counts decreased significantly in all three groups (P < 0.05) as compared with baseline. Participants in the SPL50 group had a significantly higher success rate than those in the placebo group (P < 0.05). Serum potassium and creatinine levels showed no significant changes with treatment or between groups. A small number of participants in SPL25 and SPL50 reported mild and temporary TRAE, such as menstrual irregularities, breast tenderness and dizziness. The combination of SPL 50 mg/day and topical BP proved effective in improving moderate AFA in Thai women, with an acceptable side-effect profile. We propose this regimen as an option for treating moderate AFA.",2020,Participants in the SPL50 group had a significantly higher success rate than those in the placebo group (P < 0.05).,"['adult female acne (AFA', '63 participants in the study', 'Thai women with moderate AFA', 'adult female acne', 'Moderate AFA patients aged between 25 and 45\xa0years']","['Oral spironolactone (SPL', 'combination of daily topical benzoyl peroxide (BP) 2.5% plus either SPL 25\xa0mg (SPL25 group), SPL 50\xa0mg (SPL50 group) or placebo', 'spironolactone', 'placebo', 'low-dose spironolactone and topical benzoyl peroxide', 'low-dose (25-50\xa0mg/day) oral SPL', 'SPL']","['Efficacy and tolerability', 'Serum potassium and creatinine levels', 'success rate', 'Treatment-related adverse events (TRAE', 'success rate, defined as the proportion of participants achieving a ""clear/almost clear"" AFAST grade', 'total acne counts', 'moderate AFA', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0990353', 'cui_str': 'Spironolactone 25 MG'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0992989', 'cui_str': 'Spironolactone 50 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",63.0,0.389296,Participants in the SPL50 group had a significantly higher success rate than those in the placebo group (P < 0.05).,"[{'ForeName': 'Mattana', 'Initials': 'M', 'LastName': 'Patiyasikunt', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Bussabong', 'Initials': 'B', 'LastName': 'Chancheewa', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nopadon', 'Initials': 'N', 'LastName': 'Noppakun', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chanat', 'Initials': 'C', 'LastName': 'Kumtornrut', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",The Journal of dermatology,['10.1111/1346-8138.15559']
2783,32857481,Effect of menopausal hormone therapy on proteins associated with senescence and inflammation.,"BACKGROUND


Estrogen may inhibit cell senescence that contributes to age-related disorders. This study determined the effects of menopausal hormone treatments on circulating levels of markers of cell senescence.
METHODS


Growth differentiation factor 15 (GDF15), tumor necrosis factor receptor 1 (TNFR1), FAS, and macrophage inflammatory protein 1α (MIP1α) were measured in serum using multiplexed bead-based assays and compared among menopausal women participating in the Kronos Early Estrogen Prevention Study randomized to either placebo (n = 38), oral conjugated equine estrogen (oCEE, n = 37), or transdermal 17β-estradiol (tE2, n = 34). Serum levels of the senescent markers for each treatment were compared to placebo 36 months after randomization using the Wilcoxon rank sum test.
RESULTS


Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo. The difference in levels between treatment and placebo for GDF15, TNFR1, and FAS were greater for oCEE [-108 pg/mL (p = .008), -234 pg/mL (p = .0006), and -1374 pg/mL (p < .0001), respectively] than for tE2 [-76 pg/mL (p = .072), -105 pg/mL (p = .076), and -695 pg/mL (p = .036), respectively]. Additionally, TNFR1 showed a positive association with time past menopause (correlation = 0.255, p = .019).
CONCLUSIONS


Circulating levels of some markers of cell senescence were lower in menopausal women treated with oCEE and tE2 compared to placebo. Differences in the magnitude of effect of the two active treatments may reflect the differences in circulating levels of estrogen metabolites due to formulation and mode of delivery. These data generate new hypotheses with regard to the effects of menopause on the biology of aging.",2020,"RESULTS


Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo.",['menopausal women participating in the Kronos Early Estrogen Prevention Study randomized to either'],"['TNFR1', 'placebo', 'menopausal hormone therapy', 'oCEE', 'oral conjugated equine estrogen (oCEE, n\xa0=\xa037), or transdermal 17β-estradiol', 'menopausal hormone treatments']","['GDF15, TNFR1, and FAS', 'Serum levels', 'cell senescence', 'Serum levels of GDF15, TNFR1, and FAS', 'senescence and inflammation', 'Growth differentiation factor 15 (GDF15), tumor necrosis factor receptor 1 (TNFR1), FAS, and macrophage inflammatory protein 1α (MIP1α', 'circulating levels of markers of cell senescence']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007581', 'cui_str': 'Senescence, Cellular'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.255534,"RESULTS


Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Faubion', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'White', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Geske', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nathan K', 'Initials': 'NK', 'LastName': 'LeBrasseur', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Schafer', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Mielke', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}]",Physiological reports,['10.14814/phy2.14535']
2784,32853585,"Ipilimumab, nivolumab, and brentuximab vedotin combination therapies in patients with relapsed or refractory Hodgkin lymphoma: phase 1 results of an open-label, multicentre, phase 1/2 trial.","BACKGROUND


Recognising that the immune suppressive microenvironment promotes tumour growth in Hodgkin lymphoma, we hypothesised that activating immunity might augment the activity of targeted chemotherapy. We evaluated the safety and activity of combinations of brentuximab vedotin with nivolumab or ipilimumab, or both in patients with relapsed or refractory Hodgkin lymphoma.
METHODS


In this multicentre, open-label, phase 1/2 trial, patients with relapsed or refractory Hodgkin lymphoma aged 18 years or older who had relapsed after at least one line of therapy, with an Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ and marrow function, with no pulmonary dysfunction were eligible for inclusion. Phase 1 primary objectives were to determine the maximum tolerated dose and dose limiting toxicities of brentuximab vedotin combined with ipilimumab (ipilimumab group), nivolumab (nivolumab group), or both (triplet therapy group) using a 3 + 3 dose escalation design with expansion cohorts. During the dose escalation phase, patients were enrolled sequentially into one of six cohorts: in the ipilimumab group fixed brentuximab vedotin 1·8 mg/kg with ipilimumab 1 mg/kg (cohort A) or 3 mg/kg (cohort B); in the nivolumab group fixed nivolumab 3 mg/kg with brentuximab vedotin 1·2 mg/kg (cohort D) or 1·8 mg/kg (cohort E); and in the triplet therapy group fixed nivolumab 3 mg/kg and ipilimumab 1 mg/kg with brentuximab vedotin 1·2 mg/kg (cohort G) or 1·8 mg/kg (cohort H). Additional patients were enrolled in the expansion phase at the same doses of cohorts B, E, and H. All drugs were given intravenously; brentuximab vedotin and nivolumab were given every 3 weeks, ipilimumab was given every 6 weeks in the ipilimumab group and every 12 weeks in the triplet therapy group. All eligible and treated patients were included in the analysis. This phase 1/2 study is registered with ClinicalTrials.gov, NCT01896999. The phase 2, randomised portion of the trial is still enrolling.
FINDINGS


Between March 7, 2014, and Dec 28, 2017, 64 patients were enrolled; two patients in the ipilimumab group and one patient in the nivolumab group were excluded due to ineligibility after enrolment and 61 were evaluable. A total of six dose limiting toxicities were reported in four patients, and the doses used in cohorts B, E, and H were established as maximum tolerated doses and patients were subsequently enrolled onto expansion cohorts (C, F, and I) with these schedules. There were ten (43%) grade 3-4 treatment related adverse events in the ipilimumab group, three (16%) in the nivolumab group, and 11 (50%) in the triplet therapy group including: eight (13%) of 64 patients reporting rash, and colitis, gastritis, pancreatitis and arthritis, and diabetic ketoacidosis each occurring in one (2%) patient. There were two (3%) treatment related deaths, one in the nivolumab group and one in the triplet therapy group. The overall response rate was 76% (95% CI 53-92) in the ipilimumab group, 89% (65-99) in the nivolumab group, and 82% (60-95) in the triplet therapy group, and the complete response rate was 57% (95% CI 34-78%) in the ipilimumab group, 61% (36-83%) in the nivolumab group, and 73% (50-89%) in the triplet therapy group. With a median follow-up of 2·6 years (IQR 1·8-2·9) in the ipilimumab group, 2·4 years (2·2-2·6) in the nivolumab group, and 1·7 years (1·6-1·9) in the triplet therapy group, median progression-free survival is 1·2 years (95% CI 1·7-not reached) in the ipilimumab group, but was not reached in the other two treatment groups. Median overall survival has not been reached in any of the groups.
INTERPRETATION


There are clear differences in activity and toxicity of the three combination regimens. The tolerability and preliminary activity for the two most active regimens, brentuximab vedotin with nivolumab and the triplet therapy, are being compared in a randomised phase 2 trial (NCT01896999).
FUNDING


Eastern Cooperative Oncology Group-American College of Radiology Imaging Network and the National Cancer Institute of the National Institutes of Health.",2020,"The overall response rate was 76% (95% CI 53-92) in the ipilimumab group, 89% (65-99) in the nivolumab group, and 82% (60-95) in the triplet therapy group, and the complete response rate was 57% (95% CI 34-78%) in the ipilimumab group, 61% (36-83%) in the nivolumab group, and 73% (50-89%) in the triplet therapy group.","['patients with relapsed or refractory Hodgkin lymphoma', 'patients with relapsed or refractory Hodgkin lymphoma aged 18 years or older who had relapsed after at least one line of therapy, with an Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ and marrow function, with no pulmonary dysfunction were eligible for inclusion', 'Between March 7, 2014, and Dec 28, 2017, 64 patients were enrolled; two patients in the ipilimumab group and one patient in the nivolumab group were excluded due to ineligibility after enrolment and 61 were evaluable']","['ipilimumab (ipilimumab group), nivolumab (nivolumab group), or both (triplet therapy', 'Ipilimumab, nivolumab, and brentuximab vedotin combination therapies', 'triplet therapy group fixed nivolumab 3 mg/kg and ipilimumab 1 mg/kg with brentuximab vedotin 1·2 mg/kg', 'brentuximab vedotin with nivolumab or ipilimumab', 'ipilimumab group fixed brentuximab vedotin 1·8 mg/kg with ipilimumab', 'nivolumab group fixed nivolumab 3 mg/kg with brentuximab vedotin 1·2 mg/kg', 'ipilimumab']","['complete response rate', 'adverse events', 'overall response rate', 'maximum tolerated dose and dose limiting toxicities', 'activity and toxicity', 'median progression-free survival', 'Median overall survival', 'rash, and colitis, gastritis, pancreatitis and arthritis, and diabetic ketoacidosis', 'toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855082', 'cui_str': ""Refractory Hodgkin's lymphoma""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",64.0,0.0744334,"The overall response rate was 76% (95% CI 53-92) in the ipilimumab group, 89% (65-99) in the nivolumab group, and 82% (60-95) in the triplet therapy group, and the complete response rate was 57% (95% CI 34-78%) in the ipilimumab group, 61% (36-83%) in the nivolumab group, and 73% (50-89%) in the triplet therapy group.","[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Diefenbach', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA. Electronic address: catherine.diefenbach@nyulangone.org.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Biostatistics Center, Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Department of Oncology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jonathon B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Robertson', 'Affiliation': 'School of Medicine, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'David', 'Affiliation': 'Division of Blood Disorders, Rutgers Cancer Institute of New Jersey, New Jersey, NJ, USA.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Oncology Division, Stanford Cancer Institute, Stanford, CA, USA.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Fenske', 'Affiliation': 'Division of Hematology and Oncology, Froedtert and the Medical College of Wisconsin, Wauwatosa, WI, USA.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'Barta', 'Affiliation': 'Divison of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Palmisiano', 'Affiliation': 'Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Svoboda', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Morgan', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Karmali', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Sharon', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethseda, MD, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Streicher', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethseda, MD, USA.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'School of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester MN, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30221-0']
2785,32853634,Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Ustekinumab induces and maintains histologic improvement in patients with ulcerative colitis (UC). The clinical relevance of this endpoint alone, and in combination with endoscopic improvement, is unknown.
METHODS


Histologic disease activity were evaluated in 2630 colonic biopsy samples from patients with UC treated in the UNIFI phase 3 UC clinical studies of ustekinumab. We evaluated associations between histologic improvement (defined as the composite of neutrophil infiltration in less than 5% of crypts and no crypt destruction, erosions, ulcerations, or granulation tissue) and clinical endpoints at the end of induction (week 8 and 16) and maintenance (week 44) periods. We assessed the validity of a combined histologic and endoscopic (Mayo endoscopy subscore, 0 or 1) improvement endpoint which we called histo-endoscopic mucosal healing (or histo-endoscopic mucosal improvement).
RESULTS


Histologic improvement was significantly (P<.0001) associated with clinical remission, lower mean disease activity scores, and greater improvement in disease activity at the end of induction and maintenance studies. Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used. Histologic improvement and endoscopic improvement following induction were associated with 10%-20% higher rates of histo-endoscopic mucosal healing, clinical remission, and corticosteroid-free remission at week 44 (all P<.05) in patients who received ustekinumab maintenance therapy. At week 44, 61% of patients (56/92) with histo-endoscopic mucosal healing after induction therapy achieved clinical remission, vs 39% of patients (9/23, P=.0983) and 34% of patients (24/71, P=.0009) with endoscopic or histologic improvement alone after induction, respectively.
CONCLUSION


Data from the UNIFI program of ustekinumab in patient with UC treated with ustekinumab indicated the achievement of histo-endoscopic mucosal healing after induction therapy is associated with lower disease activity at the end of maintenance therapy than either histologic or endoscopic improvement alone. ClinicalTrials.gov number: NCT02407236.",2020,Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used.,"['Patients With Ulcerative Colitis', 'patients with ulcerative colitis (UC', '2630 colonic biopsy samples from patients with UC treated in the UNIFI phase 3 UC clinical studies of ustekinumab']","['Ustekinumab Treatment', 'ustekinumab maintenance therapy', 'placebo']","['disease activity', 'rates of histologic improvement', 'achievement of histo-endoscopic mucosal healing', 'clinical remission', 'clinical remission, lower mean disease activity scores', 'validity of a combined histologic and endoscopic (Mayo endoscopy subscore, 0 or 1) improvement endpoint which we called histo-endoscopic mucosal healing (or histo-endoscopic mucosal improvement', 'crypt destruction, erosions, ulcerations, or granulation tissue) and clinical endpoints', 'histo-endoscopic mucosal healing, clinical remission, and corticosteroid-free remission', 'Histologic improvement', 'Histologic improvement and endoscopic improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0586716', 'cui_str': 'Colonic biopsy sample'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",2630.0,0.0468271,Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Immunology Translational Science, Janssen Research & Development, LLC., Spring House, PA, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Immunology, Janssen Research & Development, LLC., Spring House, PA, USA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Immunology, Janssen Research & Development, LLC., Spring House, PA, USA.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Immunology Translational Science, Janssen Research & Development, LLC., Spring House, PA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Rubin', 'Affiliation': 'Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Gastroenterology Department and Inserm U1256 Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Friedman', 'Affiliation': 'Immunology Translational Science, Janssen Research & Development, LLC., Spring House, PA, USA. Electronic address: joshfriedman@me.com.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Hertogh', 'Affiliation': 'Deparment of Pathology, University Hospitals KU Leuven, Belgium. Electronic address: gert.dehertogh@uzleuven.be.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.037']
2786,32853647,Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone.,"BACKGROUND


Long-term testosterone replacement therapy (TRT) increases muscle mass in elderly men with subnormal testosterone levels. However, the molecular mechanisms underlying this effect of TRT on protein balance in human skeletal muscle in vivo remain to be established.
METHODS


Here, we examined skeletal muscle biopsies obtained before and 24-h after the last dose of treatment with either testosterone gel (n = 12) or placebo (n = 13) for 6 months in aging men with subnormal bioavailable testosterone levels. The placebo-controlled, testosterone-induced changes (β-coefficients) in mRNA levels, protein expression and phosphorylation were examined by quantitative real-time PCR and western blotting.
RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors. However, TRT caused a sustained decrease in protein expression of SMAD2 (β = -36%, p = 0.004) and SMAD3 (β = -32%, p = 0.001), which was accompanied by reduced protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1 (β = -26%, p = 0.004) and Atrogin-1/MAFbx (β = -20%, p = 0.04), but with no changes in FOXO3 signalling. Importantly, TRT did not affect muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres.
CONCLUSIONS


Our results indicate that long-term TRT of elderly men with subnormal testosterone levels increases muscle mass, at least in part, by decreasing protein breakdown through the ubiquitin proteasome pathway mediated by a sustained suppression of SMAD-signalling and muscle-specific E3-ubiquitin ligases.",2020,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","['aging men with subnormal testosterone', 'elderly men with subnormal testosterone levels']","['testosterone replacement therapy (TRT', 'long-term testosterone therapy', 'placebo', 'testosterone gel', 'TRT']","['muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres', 'protein expression of SMAD2', 'Atrogin-1/MAFbx', 'muscle mass', 'skeletal muscle mass and fibre-type distribution', 'protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1', 'mRNA levels, protein expression and phosphorylation', 'mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1566790', 'cui_str': 'SMAD2 protein, human'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041538', 'cui_str': 'Ubiquitin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0076925', 'cui_str': 'USF Transcription Factors'}]",,0.0809258,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","[{'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Kruse', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense, C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense, C, Denmark.'}, {'ForeName': 'Stine J', 'Initials': 'SJ', 'LastName': 'Petersson', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense, C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense, C, Denmark.'}, {'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense, C, Denmark.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense, C, Denmark; Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'Rugivan', 'Initials': 'R', 'LastName': 'Sabaratnam', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense, C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense, C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, DK-5230 Odense, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense, C, Denmark.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Højlund', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense, C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense, C, Denmark. Electronic address: kurt.hoejlund@rsyd.dk.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154347']
2787,32853672,NSafety and Effectiveness of Azithromycin in Patients with COVID-19: an open-label randomized trial.,"BACKGROUND


As no specific pharmacologic treatment has been validated for use in COVID-19, we aimed to assess the effectiveness of azithromycin in these patients at a referral center in Iran.
METHODS


An open-label, randomized, and controlled trial was conducted on patients with laboratory confirmed COVID-19. The 55 patients of the control group receiving hydroxychloroquine and lopinavir / ritonavir were compared with the 56 patients of the case group who in addition to the same regimen were also receiving azithromycin. Patients with prior cardiac disease were excluded from the study. Furthermore, patients from the case group were assessed for cardiac arrythmia risk based on the American college of cardiology (ACC) risk assessment for use of azithromycin and hydroxychloroquine. The main outcome measures were vital signs, SpO2 levels, duration of hospitalization, need for and length of intensive care unit (ICU) admission, mortality rates, and results of 30-day follow-up after discharge.
RESULTS


Initially, there was no significant difference between the general conditions and vital signs of the two groups. The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group. There was no significant difference in the mortality rate between the two groups.
CONCLUSION


Patients who received azithromycin in addition to the hydroxychloroquine and Kaletra regimen had a better general condition. he hydroxychloroquine-azithromycin combination may be beneficial for individuals who are known to have a very low underlying risk for cardiac arrhythmias based on the ACC criteria.",2020,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","['patients at a referral center in Iran', 'Patients with COVID-19', 'Patients with prior cardiac disease', 'patients with laboratory confirmed COVID-19']","['hydroxychloroquine', 'azithromycin and hydroxychloroquine', 'azithromycin', 'hydroxychloroquine-azithromycin', 'hydroxychloroquine and lopinavir / ritonavir', 'Azithromycin']","['respiratory rate', 'duration of admission', 'mortality rate', 'SpO2 levels at discharge', 'cardiac arrythmia risk', 'vital signs, SpO2 levels, duration of hospitalization, need for and length of intensive care unit (ICU) admission, mortality rates, and results of 30-day follow-up after discharge', 'general conditions and vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0611014,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Sekhavati', 'Affiliation': 'Assistant Professor of Cardiology, Department of Cardiology, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Mazandaran University of medical sciences, school of medicine, Sari, Iran; Iran University of medical sciences, school of medicine, Tehran, Iran.'}, {'ForeName': 'SeyedAhmad', 'Initials': 'S', 'LastName': 'SeyedAlinaghi', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeidreza Jamali Moghadam', 'Initials': 'SJM', 'LastName': 'Siahkali', 'Affiliation': 'Department of Infectious Diseases, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sadr', 'Affiliation': 'Mazandaran University of medical sciences, school of medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabarestani', 'Affiliation': 'Medical Students Research Committee, Mazandaran University of medical sciences, school of medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pirhayati', 'Affiliation': 'Iran University of medical sciences, school of medicine, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Zendehdel', 'Affiliation': 'Associate Professor of Internal Medicine, Geriatric Department, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Manafi', 'Affiliation': 'Iran University of medical sciences, school of medicine, Tehran, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ahmadinejad', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Emadi', 'Initials': 'HE', 'LastName': 'Kouchak', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Jafari', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of pharmacotherapy, faculty of pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Seifi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh Shahmari', 'Initials': 'FS', 'LastName': 'Golestan', 'Affiliation': 'Nurse Working In Department of Infectious Diseases, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghiasvand', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghiasvand_62@yahoo.com.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106143']
2788,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE


Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS


This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS


After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION


The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
2789,32853919,Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®).,"OBJECTIVE


To validate automatic sleep stage classification using deep neural networks on sleep assessed by radar technology in the commercially available sleep assistant Somnofy® against polysomnography (PSG).
METHODS


Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions. The Somnofy unit was placed in two different locations per room (nightstand and wall). The sleep algorithm was validated against PSG using a 25-fold cross validation technique, and performance was compared to the inter-rater reliability between the PSG sleep scored by two independent sleep specialists.
RESULTS


Epoch-by-epoch analyses showed a sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake) for Somnofy of 0.97 and 0.72 respectively, compared to 0.99 and 0.85 for the PSG scorers. The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96. The intraclass correlation coefficient revealed excellent and good reliability for total sleep time and sleep efficiency, while sleep onset and R latency had poor agreement. Somnofy underestimated total wake time by 5 min and N1/N2 by 3 min. N3 was overestimated by 4 min and R by 3 min. Results were independent of institution and sensor location.
CONCLUSION


Somnofy showed a high accuracy staging sleep in healthy individuals and has potential to assess sleep quality and quantity in a sample of healthy, mostly young adults. More research is needed to examine performance in children, older individuals and those with sleep disorders.",2020,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","['children, older individuals and those with sleep disorders', 'Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions', 'healthy individuals']",['non-contact radar technology and machine learning (Somnofy®'],"['sleep stage differentiation', 'total wake time', 'accuracy staging sleep', 'total sleep time and sleep efficiency', 'sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0201471,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","[{'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Toften', 'Affiliation': 'Department of Data Science, VitalThings AS, Tønsberg, Norway. Electronic address: st@vitalthings.com.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway; Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hrozanova', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Moen', 'Affiliation': 'Department of Education and Lifelong Learning, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.022']
2790,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
2791,32854052,Does symptom severity matter in stepped and collaborative care for depression?,"BACKGROUND


We investigated the differential effectiveness of a stepped and collaborative care model (SCM) vs. treatment as usual (TAU) for primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments.
METHODS


Subgroup analyses of a RCT were calculated applying a multiple linear mixed model with the factors 1. group (SCM; TAU), 2. severity ((mild-moderate (MMD); severe depression (SD)) and their interaction, with PHQ-9 as primary outcome. Utilization of treatments was analyzed descriptively.
RESULTS


For the 737 participating patients (SCM: n = 569; TAU: n = 168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70%. ITT-analysis (Last-observation-carried-forward) revealed a significant interaction for group x severity [p = 0.036] and a significant difference between groups in symptom reduction for MMD (-3.9; [95% CI: -5.1 to -2.6, p < 0.001; d = 0.64] but not for SD (-1.6; [95% CI: -3.4 to 0.2, p = 0.093; d = 0.27]. Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD. Differences between SCM and TAU in the percentage of patients utilizing depression-specific treatments are larger for MMD.
LIMITATIONS


There was a high proportion of missing values among severely depressed patients, especially in SCM.
CONCLUSION


SCM is effective for both MMD and SD. Utilization patterns might help explain the higher effects for MMD. Various strategies of replacement of missing values lead to slightly divergent results due to selective drop out between severity groups.",2020,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","['primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments', '737 participating patients (SCM: n\xa0=\xa0569; TAU: n\xa0=\xa0168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70']","['SCM', 'SCM and TAU', 'stepped and collaborative care model (SCM) vs. treatment as usual (TAU']",['severity ((mild-moderate (MMD); severe depression (SD'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}]",737.0,0.0676647,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Watzke', 'Affiliation': 'Clinical Psychology and Psychotherapy Research, Institute of Psychology, University of Zurich, Binzmühlestrasse 14/16, CH-8050 Zurich, Switzerland. Electronic address: birgit.watzke@uzh.ch.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: d.heddaeus@uke.de.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Steinmann', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.steinmann@uke.de.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: a.daubmann@uke.de.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: k.wegscheider@uke.uni-hamburg.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.haerter@uke.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.079']
2792,32854533,Treatment-Specific Associations Between Brain Activation and Symptom Reduction in OCD Following CBT: A Randomized fMRI Trial.,"OBJECTIVE


The authors sought to examine whether brain activity is associated with treatment response to cognitive-behavioral therapy (CBT) in adolescents and adults with obsessive-compulsive disorder (OCD), and whether any associations are treatment specific relative to an active control psychotherapy (stress management therapy; SMT).
METHODS


Eighty-seven patients with OCD (age range 12-45 years; 57 female, 39 medicated) were randomly assigned to receive 12 weeks of CBT or SMT. Prior to treatment, functional MRI scans were conducted in patients performing an incentive flanker task, which probes brain activation to both cognitive control and reward processing. Voxelwise linear mixed-effects models examined whether baseline brain activation was differentially associated with change in scores on the Yale-Brown Obsessive Compulsive Scale (standard or Children's version) over the course of CBT or SMT treatment.
RESULTS


Within the CBT group, a better treatment response was significantly associated with greater pretreatment activation within the right temporal lobe and rostral anterior cingulate cortex during cognitive control and within the ventromedial prefrontal, orbitofrontal, lateral prefrontal, and amygdala regions during reward processing. In contrast, reduced pretreatment activation within a largely overlapping set of regions was significantly associated with a better treatment response to SMT.
CONCLUSIONS


The study findings demonstrate that associations between brain activation and treatment response were treatment specific to CBT relative to a control psychotherapy and that these associations were stable from adolescence to mature adulthood. Such treatment-specific associations are important for the development of biomarkers to personalize treatment in OCD.",2020,"Within the CBT group, a better treatment response was significantly associated with greater pretreatment activation within the right temporal lobe and rostral anterior cingulate cortex during cognitive control and within the ventromedial prefrontal, orbitofrontal, lateral prefrontal, and amygdala regions during reward processing.","['Eighty-seven patients with OCD (age range 12-45 years; 57 female, 39 medicated', 'adolescents and adults with obsessive-compulsive disorder (OCD']","['CBT', 'CBT or SMT', 'cognitive-behavioral therapy (CBT']","['baseline brain activation', 'Yale-Brown Obsessive Compulsive Scale', 'Brain Activation and Symptom Reduction in OCD']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",87.0,0.021467,"Within the CBT group, a better treatment response was significantly associated with greater pretreatment activation within the right temporal lobe and rostral anterior cingulate cortex during cognitive control and within the ventromedial prefrontal, orbitofrontal, lateral prefrontal, and amygdala regions during reward processing.","[{'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Norman', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Mannella', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Angstadt', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Abelson', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Himle', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}, {'ForeName': 'Kate D', 'Initials': 'KD', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}, {'ForeName': 'Stephan F', 'Initials': 'SF', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry, Medical School, University of Michigan, Ann Arbor (Norman, Mannella, Yang, Angstadt, Abelson, Himle, Fitzgerald, Taylor); Neurobehavioral Clinical Research Section, Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, Md. (Norman); Second Xiangya Hospital, Central South University, Changsha, China (Yang).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2020.19080886']
2793,32854537,Effect of consuming a late-night high-protein/moderate-carbohydrate vs. low-protein/high-carbohydrate meal by night workers on their food perceptions later during the day: a randomized crossover study.,"It is typical of night workers to consume a large dinner meal before their work shift, even though this practice may increase the risk for metabolic disorders. Night workers usually eat at night to socialize with colleagues as well as to stay alert and to avoid upset stomach during the night shift. However, little is known if and how the composition of the nighttime meal by night shift workers influences their food perceptions and eating behavior later during the day. The aim of this study was to analyze the effect of a high-protein/moderate-carbohydrate (HP/MCHO) meal vs. low-protein/high-carbohydrate (LP/HCHO) meal eaten at night by night-shift workers on their food consumption and perceptions later during the day. Fourteen male night shift workers were followed-up for 7 days for their eating and sleep habits. Then, participants underwent two isocaloric dietary events - one event a HP/MCHO meal containing 45% carbohydrate, 35% protein, and 20% fat and the other event a LP/HCHO meal containing 65% carbohydrate, 15% protein, and 20% fat, with a 6-day washout period between them - at 01:00 h during their night shift. Thereafter throughout the day, participants filled a food register of all the food consumed and perceptions, including hunger before meals, enjoyment of meals, and satiety. Generalized estimating equation analyses were used to examine the effect of both conditions on food consumption and food perceptions. Appetite for salty food snacks was greater after the HP/MCHO condition than after the LP/HCHO condition ( p  = .041). During the day following consumption of the nighttime HP/MCHO vs. LP/HCHO meal, there was higher percentage of carbohydrate consumption during lunch and a lower percentage of fat consumption during dinner (48.14% vs. 36.98% and 27.34% vs. 40.39%, respectively). These findings suggest the composition in terms of carbohydrates, protein, and fats of the meal consumed for the night shift by night workers may affect later during the day both food consumption and perceptions.",2020,Appetite for salty food snacks was greater after the HP/MCHO condition than after the LP/HCHO condition ( p  = .041).,"['Fourteen male night shift workers', 'night workers on their food perceptions later during the day']","['high-protein/moderate-carbohydrate (HP/MCHO) meal vs. low-protein/high-carbohydrate (LP/HCHO) meal eaten', 'consuming a late-night high-protein/moderate-carbohydrate vs. low-protein/high-carbohydrate meal', 'nighttime HP/MCHO vs. LP/HCHO meal', 'isocaloric dietary events - one event a HP/MCHO meal containing 45% carbohydrate, 35% protein, and 20% fat and the other event a LP/HCHO meal containing 65% carbohydrate, 15% protein, and 20% fat']","['Appetite for salty food snacks', 'fat consumption', 'carbohydrate consumption']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0555008', 'cui_str': 'Night shift worker'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein (a)'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0453862', 'cui_str': 'Salty food'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",14.0,0.014578,Appetite for salty food snacks was greater after the HP/MCHO condition than after the LP/HCHO condition ( p  = .041).,"[{'ForeName': 'Catarina Mendes', 'Initials': 'CM', 'LastName': 'Silva', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Nayara Bernardes Da', 'Initials': 'NBD', 'LastName': 'Cunha', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Maria Carliana', 'Initials': 'MC', 'LastName': 'Mota', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Luisa Pereira', 'Initials': 'LP', 'LastName': 'Marot', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Kely Raspante Cerqueira', 'Initials': 'KRC', 'LastName': 'Teixeira', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Thulio Marquez', 'Initials': 'TM', 'LastName': 'Cunha', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Cibele Aparecida', 'Initials': 'CA', 'LastName': 'Crispim', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}]",Chronobiology international,['10.1080/07420528.2020.1807561']
2794,32854563,Use of alcohol containing caps for preventing bloodstream infections: A randomized controlled trial.,"BACKGROUND


A majority of bloodstream infections seen in intensive care units stem from intravascular catheters used on patients. Catheter hubs are the entrance for pathogenic microorganisms into the inner surfaces of the catheters. The pathogenic microorganisms colonization in the mentioned areas can cause central line-associated bloodstream infection (CLABSI).
METHODS


This study was conducted as a randomized controlled trial to investigate the effect of alcohol-containing caps on the prevention of CLABSI. Total of 95 patients participated in the study. Isopropyl alcohol-containing caps were used for protecting the needle-free connectors closing the hubs of the central venous catheters in the intervention group. However, the control group patient received standard catheter caps.
RESULT


There was a statistically significant difference between groups in terms of infection distribution (X2 = 13.058;  p  < 0.001). The risk of infection in the control group was 13.7 times higher than the risk of infection in the intervention group.
DISCUSSION


Our results suggest that alcohol-containing caps are effective or in preventing CLABSI.
CONCLUSION


These findings suggest that alcohol-containing caps on ports are effective in preventing CLABSI.",2020,"The risk of infection in the control group was 13.7 times higher than the risk of infection in the intervention group.
",['Total of 95 patients participated in the study'],"['standard catheter caps', 'Isopropyl alcohol-containing caps', 'alcohol-containing caps', 'alcohol containing caps']","['risk of infection', 'bloodstream infections', 'infection distribution']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",95.0,0.0305145,"The risk of infection in the control group was 13.7 times higher than the risk of infection in the intervention group.
","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Taşdelen Öğülmen', 'Affiliation': 'Infection Control Nurse, Kartal Koşuyolu High Speciality Educational And Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Sebahat', 'Initials': 'S', 'LastName': 'Ateş', 'Affiliation': 'School of Nursing, Maltepe Üniversity, İstanbul, Turkey.'}]",The journal of vascular access,['10.1177/1129729820952961']
2795,32854568,"The effects of roflumilast, a phosphodiesterase type-4 inhibitor, on EEG biomarkers in schizophrenia: A randomised controlled trial.","BACKGROUND


Patients with schizophrenia have significant cognitive deficits, which may profoundly impair quality of life. These deficits are also evident at the neurophysiological level with patients demonstrating altered event-related potential in several stages of cognitive processing compared to healthy controls; within the auditory domain, for example, there are replicated alterations in Mismatch Negativity, P300 and Auditory Steady State Response. However, there are no approved pharmacological treatments for cognitive deficits in schizophrenia.
AIMS


Here we examine whether the phosphodiesterase-4 inhibitor, roflumilast, can improve neurophysiological deficits in schizophrenia.
METHODS


Using a randomised, double-blind, placebo-controlled, crossover design study in 18 patients with schizophrenia, the effect of the phosphodiesterase-4 inhibitor, roflumilast (100 µg and 250 µg) on auditory steady state response (early stage), mismatch negativity and theta (intermediate stage) and P300 (late stage) was examined using electroencephalogram. A total of 18 subjects were randomised and included in the analysis.
RESULTS


Roflumilast 250 µg significantly enhanced the amplitude of both the mismatch negativity ( p =0.04) and working memory-related theta oscillations ( p =0.02) compared to placebo but not in the other (early- or late-stage) cognitive markers.
CONCLUSIONS


The results suggest that phosphodiesterase-4 inhibition, with roflumilast, can improve electroencephalogram cognitive markers, which are impaired in schizophrenia, and that phosphodiesterase-4 inhibition acts at an intermediate rather than early or late cognitive processing stage. This study also underlines the use of neurophysiological measures as cognitive biomarkers in experimental medicine.",2020,"RESULTS


Roflumilast 250 µg significantly enhanced the amplitude of both the mismatch negativity ( p =0.04) and working memory-related theta oscillations ( p =0.02) compared to placebo but not in the other (early- or late-stage) cognitive markers.
","['100 µg and 250 µg) on auditory steady state response (early stage), mismatch negativity and theta (intermediate stage) and P300 (late stage) was examined using electroencephalogram', 'A total of 18 subjects were randomised and included in the analysis', 'schizophrenia', '18 patients with schizophrenia, the effect of the', 'Patients with schizophrenia']","['placebo', 'roflumilast', 'phosphodiesterase-4 inhibitor, roflumilast']","['electroencephalogram cognitive markers', 'amplitude of both the mismatch negativity', 'working memory-related theta oscillations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C2936609', 'cui_str': 'Phosphodiesterase 4 inhibitor'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",18.0,0.1707,"RESULTS


Roflumilast 250 µg significantly enhanced the amplitude of both the mismatch negativity ( p =0.04) and working memory-related theta oscillations ( p =0.02) compared to placebo but not in the other (early- or late-stage) cognitive markers.
","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gilleen', 'Affiliation': 'Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Nottage', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Yakub', 'Affiliation': 'Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kerins', 'Affiliation': 'Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Valdearenas', 'Affiliation': 'Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Uz', 'Affiliation': 'Takeda Development Center Americas, Deerfield, USA.'}, {'ForeName': 'Gez', 'Initials': 'G', 'LastName': 'Lahu', 'Affiliation': 'Takeda Development Center Americas, Deerfield, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ogrinc', 'Affiliation': 'Takeda Development Center Americas, Deerfield, USA.'}, {'ForeName': 'Steve C', 'Initials': 'SC', 'LastName': 'Williams', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Ffytche', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Sukhi S', 'Initials': 'SS', 'LastName': 'Shergill', 'Affiliation': 'Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120946300']
2796,32854752,"The effect of psychoeducational intervention, based on a self-regulation model on menstrual distress in adolescents: a protocol of a randomized controlled trial.","INTRODUCTION


Menstrual distress caused by primary dysmenorrhea is associated with physical and psychological symptoms-before, after, and during menstruation. Leventhal's self-regulation educational model is based on the cognitive and emotional experiences of threat responses to symptoms and relates to coping responses. This study aims to investigate the effect of the implementation of a psychoeducational intervention, based on the self-regulation model of menstrual distress in adolescents.
METHODS/DESIGN


In this randomized controlled trial, 120 adolescent girls with moderate to severe menstrual pain (based on visual analog scale (VAS) ≥ 4) from twelve randomly selected high schools in Qazvin City will be enrolled in the study and will be randomly assigned to either a 3-session psychoeducational intervention (n = 60) or control (n = 60) groups. The sessions will be between 60 and 90 min apiece, and they will run for three consecutive weeks (one session per week). The data collection tools will include questionnaire eliciting menstrual information and demographics, the VAS, the Moos Menstrual Distress Questionnaire, and the illness perception questionnaire. One month prior to the intervention, both groups will participate in an initial assessment to assess the severity of their pain and level of menstrual distress. Finally, all questionnaires will be completed for three consecutive months after the intervention is completed.
DISCUSSION


It is anticipated that findings of this study will provide evidence for the effectiveness of the Leventhal self-regulation model. Implications for improved practice, understanding, and treatment for menstrual distress may also arise.
ETHICAL CONSIDERATIONS


The research protocol will be reviewed by the ethics committee, which is affiliated with the Qazvin University of Medical Sciences (Decree code: IR.QUMS.REC.1398.043).
TRIAL REGISTRATION


IRCT20190625044002N1 . Registration date: 2019-09-03.",2020,"This study aims to investigate the effect of the implementation of a psychoeducational intervention, based on the self-regulation model of menstrual distress in adolescents.
","['120 adolescent girls with moderate to severe menstrual pain (based on visual analog scale (VAS) ≥\u20094) from twelve randomly selected high schools in Qazvin City', 'menstrual distress in adolescents']","['3-session psychoeducational intervention (n\u2009=\u200960) or control', 'self-regulation model', 'psychoeducational intervention']",['severity of their pain and level of menstrual distress'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",120.0,0.0591294,"This study aims to investigate the effect of the implementation of a psychoeducational intervention, based on the self-regulation model of menstrual distress in adolescents.
","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoardi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, 3419759811, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Soleimani', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, 3419759811, Iran.'}, {'ForeName': 'Kelly-Ann', 'Initials': 'KA', 'LastName': 'Allen', 'Affiliation': 'Educational Psychology and Inclusive Education, Faculty of Education, Monash University and The Centre for Positive Psychology, The Melbourne Graduate School of Education, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, 3419759811, Iran. nbahrami@qums.ac.ir.'}]",Trials,['10.1186/s13063-020-04629-z']
2797,32854756,"Efficacy of Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to) for patients with hyperlipidemia: a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial.","BACKGROUND


The prevalence of hyperlipidemia continues to increase due to aging and lifestyle changes. Statins are currently used as the first choice for treating hyperlipidemia, but are limited by adverse reactions. Hwangryunhaedok-tang (HHT) has received attention as a promising intervention for hyperlipidemia through a few experimental and clinical trials. This study aims to explore the feasibility, effectiveness, and safety of HHT for hyperlipidemia treatment.
METHODS


This is a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated, pilot clinical trial held in Daejeon, Republic of Korea. Thirty patients with hyperlipidemia will be randomly allocated to HHT or placebo granule groups in equal proportions. Participants will be administered HHT or placebo granules three times per day for 8 weeks and followed up for another 4 weeks. The primary outcome is low-density lipoprotein cholesterol at 8 weeks from the commencement of treatment. Other blood lipid parameters, biomarkers of atherosclerosis, the degree of arteriosclerosis, blood glucose parameters, blood pressure, anthropometric parameters, health-related quality of life, and the changes in the general symptoms of cold and hot patterns will be measured as secondary outcomes. Adverse events and laboratory test results will be investigated to assess the safety. Changes in the gut microbiome before and after intervention will also be assessed as an exploratory outcome through next-generation sequencing. Data will be recorded in electronic case report forms and analyzed using SAS® Version 9.4.
DISCUSSION


This is a rigorously designed pilot clinical trial to explore the effect and safety of Hwangryunhaedok-tang compared to placebo control for patients with hyperlipidemia, thereby potentially facilitating better management of hyperlipidemia. The results of this pilot study could form the foundation for a future large-scale, confirmatory clinical trial.
TRIAL REGISTRATION


Clinical Research Information Service KCT0004564 . Registered on December 18, 2019.",2020,"This is a rigorously designed pilot clinical trial to explore the effect and safety of Hwangryunhaedok-tang compared to placebo control for patients with hyperlipidemia, thereby potentially facilitating better management of hyperlipidemia.","['Thirty patients with hyperlipidemia', 'patients with hyperlipidemia']","['Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to', 'placebo control', 'HHT or placebo', 'HHT', 'placebo', 'Hwangryunhaedok-tang (HHT', 'Hwangryunhaedok-tang']","['blood lipid parameters, biomarkers of atherosclerosis, the degree of arteriosclerosis, blood glucose parameters, blood pressure, anthropometric parameters, health-related quality of life, and the changes in the general symptoms of cold and hot patterns', 'low-density lipoprotein cholesterol']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}]","[{'cui': 'C4705313', 'cui_str': 'hwangryunhaedok-tang'}, {'cui': 'C1869987', 'cui_str': 'Huang-Lian-Jie-Du'}, {'cui': 'C0069601', 'cui_str': 'oren gedoku to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003850', 'cui_str': 'Arteriosclerosis'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",30.0,0.556696,"This is a rigorously designed pilot clinical trial to explore the effect and safety of Hwangryunhaedok-tang compared to placebo control for patients with hyperlipidemia, thereby potentially facilitating better management of hyperlipidemia.","[{'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Kyungsun', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Hyo-Ju', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Ae-Ran', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'O-Jin', 'Initials': 'OJ', 'LastName': 'Kwon', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Changsop', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, 34054, Republic of Korea. yangunja@kiom.re.kr.'}, {'ForeName': 'Chung-Sik', 'Initials': 'CS', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Daejeon Korean Medicine Hospital of Daejeon University, Daedeok-daero 176 beon-gil 75, Seo-gu, Daejeon, 35235, Republic of Korea. choo1o2@dju.kr.'}]",Trials,['10.1186/s13063-020-04695-3']
2798,32854761,Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial.,"BACKGROUND


In December 2019, pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly. Patients with severe disease have a poor prognosis, and there are no effective therapies for COVID-19. Only rapid advice guidelines for symptomatic supportive care have been used. A traditional Chinese medicine rehabilitation (TCMR) program consisting of acupressure therapy and Liu Zi Jue Qigong can be used as a complementary therapy for COVID-19. Hence, we designed a randomized trial to evaluate the efficacy and advantages of TCMR for treating patients with severe COVID-19.
METHODS/DESIGN


This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. A total of 128 patients with COVID-19 aged from 20 to 80 years will be recruited and assigned randomly into a guideline therapy group and a guideline therapy plus TCMR group at a 1:1 ratio. Patients in both groups will receive guideline therapy. The patients in the intervention group will perform acupressure therapy and Liu Zi Jue Qigong exercises in addition to conventional treatments twice a day and will be persistent from admission to discharge. The primary outcome will be measured with the Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Activities of Daily Living Barthel Index Scale, Patient Health Questionnaire-9 Scale, and the Respiratory Symptoms Scale. The assessments of the clinical scales will be performed at three points (before treatment, the 7th day during hospitalization, and the discharge day). Adverse events will be noted and recorded for the safety evaluation.
DISCUSSION


This trial will provide high-quality evidence of the value of TCMR, which consists of acupressure therapy and Liu Zi Jue Qigong exercises, for treating patients with severe COVID-19.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2000029994 . Registered on 18 February 2020.",2020,A traditional Chinese medicine rehabilitation (TCMR) program consisting of acupressure therapy and Liu Zi Jue Qigong can be used as a complementary therapy for COVID-19.,"['patients with severe COVID-19', 'patients with severe novel coronavirus pneumonia (COVID-19', 'Patients with severe disease', 'In December 2019, pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China', '128 patients with COVID-19 aged from 20 to 80\u2009years']","['TCMR', 'acupressure therapy and Liu Zi Jue Qigong exercises', 'acupressure therapy and Liu Zi Jue Qigong', 'Acupressure therapy and Liu Zi Jue Qigong', 'guideline therapy group and a guideline therapy plus TCMR', 'guideline therapy']","['Adverse events', 'pulmonary function and quality of life', 'Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Activities of Daily Living Barthel Index Scale, Patient Health Questionnaire-9 Scale, and the Respiratory Symptoms Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",128.0,0.134178,A traditional Chinese medicine rehabilitation (TCMR) program consisting of acupressure therapy and Liu Zi Jue Qigong can be used as a complementary therapy for COVID-19.,"[{'ForeName': 'Shuaipan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Qingguang', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhan', 'Affiliation': 'Huangshi Hospital of Traditional Chinese Medicine, Huangshi, Hubei, 435000, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Huangshi Hospital of Traditional Chinese Medicine, Huangshi, Hubei, 435000, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Mingfang', 'Affiliation': 'Huangshi Hospital of Traditional Chinese Medicine, Huangshi, Hubei, 435000, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. fangmin19650510@163.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. fanglei586@126.com.'}]",Trials,['10.1186/s13063-020-04693-5']
2799,32854772,Rivaroxaban compared to no treatment in ER-negative stage I-III early breast cancer patients (the TIP Trial): study protocol for a phase II preoperative window-of-opportunity study design randomised controlled trial.,"BACKGROUND


Breast cancer patients are at a four-fold increased risk of developing a venous thromboembolism (VTE), a major cause of death in this group. Conversely, coagulation factors promote tumour growth and metastasis. This has been evidenced in preclinical models, with an inhibitory effect of anticoagulants on cancer growth through proliferative, angiogenic, apoptotic, cancer stem cell and metastatic processes. The extrinsic clotting pathway is also more upregulated in patients in the relatively poorer prognosis oestrogen receptor (ER)-negative breast cancer subgroup, with increased tumour stromal expression of the coagulation factors Tissue Factor and thrombin. Rivaroxaban (Xarelto®, Bayer AG, Leverkusen, Germany) is a direct oral anticoagulant (DOAC). It is a Factor Xa inhibitor that is routinely prescribed for the prevention of stroke in non-valvular atrial fibrillation and for both VTE prophylaxis and treatment. This trial will assess the anti-proliferative and other anti-cancer progression mechanisms of Rivaroxaban in ER-negative early breast cancer patients.
METHODS


This UK-based preoperative window-of-opportunity phase II randomised control trial will randomise 88 treatment-naïve early breast cancer patients to receive 20 mg OD Rivaroxaban treatment for 11 to 17 days or no treatment. Treatment will be stopped 24 h (range 18-36 h) prior to surgery or repeat core biopsy. All patients will be followed up for 2 weeks following surgery or repeat core biopsy. The primary endpoint is change in tumour Ki67. Secondary outcome measures include tumour markers of apoptosis and angiogenesis, extrinsic clotting pathway activation and systemic markers of metastasis, tumour load and coagulation.
DISCUSSION


Laboratory evidence supports an anti-cancer role for anticoagulants; however, this has failed to translate into survival benefit when trialled in patients with metastatic disease or poor prognosis cancers, such as lung cancer. Subgroup analysis supported a potential survival benefit in better prognosis advanced disease patients. This is the first study to investigate the anti-cancer effects of anticoagulants in early breast cancer.
TRIAL REGISTRATION


UK National Research Ethics Service (NRES) approval 15/NW/0406, MHRA Clinical Trials Authorisation 48380/0003/001-0001. The sponsor is Manchester University NHS Foundation Trust, and the trial is co-ordinated by Cancer Research UK Liverpool Cancer Trials Unit (LCTU). EudraCT 2014-004909-33 , registered 27 July 2015. ISRCTN14785273 .",2020,"The extrinsic clotting pathway is also more upregulated in patients in the relatively poorer prognosis oestrogen receptor (ER)-negative breast cancer subgroup, with increased tumour stromal expression of the coagulation factors Tissue Factor and thrombin.","['prognosis advanced disease patients', 'ER-negative early breast cancer patients', 'Breast cancer patients', '88 treatment-naïve early breast cancer patients', 'patients with metastatic disease or poor prognosis cancers', 'ER-negative stage I-III early breast cancer patients']","['20\u2009mg OD Rivaroxaban', 'Rivaroxaban', 'Rivaroxaban (Xarelto®, Bayer AG, Leverkusen, Germany']","['tumour markers of apoptosis and angiogenesis, extrinsic clotting pathway activation and systemic markers of metastasis, tumour load and coagulation', 'potential survival benefit', 'change in tumour Ki67']","[{'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3159309', 'cui_str': 'Xarelto'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C1869090', 'cui_str': 'Tumour markers (SMQ)'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.108316,"The extrinsic clotting pathway is also more upregulated in patients in the relatively poorer prognosis oestrogen receptor (ER)-negative breast cancer subgroup, with increased tumour stromal expression of the coagulation factors Tissue Factor and thrombin.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Castle', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Blower', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Bundred', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Harvey', 'Affiliation': 'The Nightingale Centre, Wythenshawe Hospital, Manchester, M23 9LT, UK.'}, {'ForeName': 'Jecko', 'Initials': 'J', 'LastName': 'Thachil', 'Affiliation': 'Department of Haematology, Manchester Royal Infirmary, Manchester, M13 9WL, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Department of Breast Surgery, Maidstone Hospital, Maidstone, ME16 9QQ, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cicconi', 'Affiliation': 'Cancer Research UK Liverpool Cancer Trials Unit, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Holcombe', 'Affiliation': 'Breast Unit, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, L3 9TA, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Palmieri', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK. cliona.kirwan@manchester.ac.uk.'}]",Trials,['10.1186/s13063-020-04675-7']
2800,32857949,Mastering the Complex Targeted Therapy for Non-small Cell Lung Cancer.,"In a recent Nature article, Middleton et al. report the National Lung Matrix trial results where patients with previously treated non-small cell lung cancer (NSCLC) are assigned to personalized therapy based on the results of a 28-gene next-generation sequencing panel test.",2020,report the National Lung Matrix trial results where patients with previously treated non-small cell lung cancer (NSCLC) are assigned to personalized therapy based on the results of a 28-gene next-generation sequencing panel test.,['patients with previously treated non-small cell lung cancer (NSCLC'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]",[],[],,0.0288593,report the National Lung Matrix trial results where patients with previously treated non-small cell lung cancer (NSCLC) are assigned to personalized therapy based on the results of a 28-gene next-generation sequencing panel test.,"[{'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Devarakonda', 'Affiliation': 'Alvin Siteman Cancer Center at Washington University, Washington University School of Medicine, 660 S Euclid Box 8056, St. Louis, MO, USA.'}, {'ForeName': 'Ramaswamy', 'Initials': 'R', 'LastName': 'Govindan', 'Affiliation': 'Alvin Siteman Cancer Center at Washington University, Washington University School of Medicine, 660 S Euclid Box 8056, St. Louis, MO, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Morgensztern', 'Affiliation': 'Alvin Siteman Cancer Center at Washington University, Washington University School of Medicine, 660 S Euclid Box 8056, St. Louis, MO, USA. Electronic address: Danielmorgensztern@wustl.edu.'}]",Cancer cell,['10.1016/j.ccell.2020.07.011']
2801,32857955,"Immediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health, and intimate partner violence in Bangladeshi women and their families: an interrupted time series.","BACKGROUND


Stay-at-home orders (lockdowns) have been deployed globally to control COVID-19 transmission, and might impair economic conditions and mental health, and exacerbate risk of food insecurity and intimate partner violence. The effect of lockdowns in low-income and middle-income countries must be understood to ensure safe deployment of these interventions in less affluent settings. We aimed to determine the immediate impact of COVID-19 lockdown orders on women and their families in rural Bangladesh.
METHODS


An interrupted time series was used to compare data collected from families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown. We also assessed women's experiences of intimate partner violence during the pandemic.
RESULTS


Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent. 2414 (99·9%, 95% CI 99·6-99·9) of 2417 mothers were aware of, and adhering to, the stay-at-home advice. 2321 (96·0%, 95·2-96·7) of 2417 mothers reported a reduction in paid work for the family. Median monthly family income fell from US$212 at baseline to $59 during lockdown, and the proportion of families earning less than $1·90 per day rose from five (0·2%, 0·0-0·5) of 2422 to 992 (47·3%, 45·2-49·5) of 2096 (p<0·0001 comparing baseline with lockdown period). Before the pandemic, 136 (5·6%, 4·7-6·6) of 2420 and 65 (2·7%, 2·1-3·4) of 2420 families experienced moderate and severe food insecurity, respectively. This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001). Mothers' depression and anxiety symptoms increased during the lockdown. Among women experiencing emotional or moderate physical violence, over half reported it had increased since the lockdown.
INTERPRETATION


COVID-19 lockdowns present significant economic, psychosocial, and physical risks to the wellbeing of women and their families across economic strata in rural Bangladesh. Beyond supporting only the most socioeconomically deprived, support is needed for all affected families.
FUNDING


National Health and Medical Research Council, Australia.",2020,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","['Bangladeshi women and their families', 'Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent', ""women's experiences of intimate partner violence during the pandemic"", '2414', '2321', '2417 mothers', 'families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown', 'women and their families in rural Bangladesh', 'women experiencing emotional or moderate physical violence']",['lockdowns'],"['number of families experiencing any level of food insecurity', ""Mothers' depression and anxiety symptoms"", 'socioeconomic conditions, food insecurity, mental health, and intimate partner violence']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",3016.0,0.0664138,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","[{'ForeName': 'Jena Derakhshani', 'Initials': 'JD', 'LastName': 'Hamadani', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammed Imrul', 'Initials': 'MI', 'LastName': 'Hasan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldi', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sheikh Jamal', 'Initials': 'SJ', 'LastName': 'Hossain', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Shamima', 'Initials': 'S', 'LastName': 'Shiraji', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Saiful Alam', 'Initials': 'MSA', 'LastName': 'Bhuiyan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Syeda Fardina', 'Initials': 'SF', 'LastName': 'Mehrin', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'Department of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Tofail', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'S M Mulk Uddin', 'Initials': 'SMMU', 'LastName': 'Tipu', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Beverley-Ann', 'Initials': 'BA', 'LastName': 'Biggs', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sant-Rayn', 'Initials': 'SR', 'LastName': 'Pasricha', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia; Diagnostic Haematology, Royal Melbourne Hospital, Parkville, VIC, Australia; Clinical Haematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Parkville, VIC Australia. Electronic address: pasricha.s@wehi.edu.au.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30366-1']
2802,32857992,"Immunogenicity of a single-dose compared with a two-dose primary series followed by a booster dose of ten-valent or 13-valent pneumococcal conjugate vaccine in South African children: an open-label, randomised, non-inferiority trial.","BACKGROUND


Routine childhood immunisation with pneumococcal conjugate vaccine (PCV) has changed the epidemiology of pneumococcal disease across age groups, providing an opportunity to reconsider PCV dosing schedules. We aimed to evaluate the post-booster dose immunogenicity of ten-valent (PCV10) and 13-valent (PCV13) PCVs between infants randomly assigned to receive a single-dose compared with a two-dose primary series.
METHODS


We did an open-label, non-inferiority, randomised study in HIV-unexposed infants at a single centre in Soweto, South Africa. Infants were randomly assigned to receive one priming dose of PCV10 or PCV13 at ages 6 weeks (6w + 1 PCV10 and 6w + 1 PCV13 groups) or 14 weeks (14w + 1 PCV10 and 14w + 1 PCV13 groups) or two priming doses of PCV10 or PCV13, one each at ages 6 weeks and 14 weeks (2 + 1 PCV10 and 2 + 1 PCV13 groups); all participants then received a booster dose of PCV10 or PCV13 at 40 weeks of age. The primary endpoint was geometric mean concentrations (GMCs) of serotype-specific IgG 1 month after the booster dose, which was assessed in all participants who received PCV10 or PCV13 as per the assigned randomisation group and for whom laboratory results were available at that timepoint. The 1 + 1 vaccine schedule was considered non-inferior to the 2 + 1 vaccine schedule if the lower bound of the 96% CI for the GMC ratio was greater than 0·5 for at least ten PCV13 serotypes and eight PCV10 serotypes. Safety was a secondary endpoint. This trial is registered with ClinicalTrials.gov (NCT02943902) and is ongoing.
FINDINGS


Of 1695 children assessed, 600 were enrolled and randomly assigned to one of the six groups between Jan 9 and Sept 20, 2017; 542 were included in the final analysis of the primary endpoint (86-93 per group). For both PCV13 and PCV10, a 1+1 dosing schedule (either beginning at 6 or 14 weeks) was non-inferior to a 2 + 1 schedule. For PCV13, the lower limit of the 96% CI for the ratio of GMCs between the 1 + 1 and 2 + 1 groups was higher than 0·5 for ten serotypes in the 6w+1 group (excluding 6B, 14, and 23F) and 11 serotypes in the 14w + 1 group (excluding 6B and 23F). For PCV10, the lower limit of the 96% CI for the ratio of GMCs was higher than 0·5 for all ten serotypes in the 6w+1 and 14w + 1 groups. 84 serious adverse events were reported in 72 (12%) of 600 participants. 15 occurred within 28 days of vaccination, but none were considered to be related to PCV injection. There were no cases of culture-confirmed invasive pneumococcal disease.
INTERPRETATION


The non-inferiority in post-booster immune responses following a single-dose compared with a two-dose primary series of PCV13 or PCV10 indicates the potential for reducing PCV dosing schedules from a 2 + 1 to 1 + 1 series in low-income and middle-income settings with well established PCV immunisation programmes.
FUNDING


The Bill & Melinda Gates Foundation (OPP1 + 152352).",2020,84 serious adverse events were reported in 72 (12%) of 600 participants.,"['HIV-unexposed infants at a single centre in Soweto, South Africa', 'South African children', 'Of 1695 children assessed, 600 were enrolled and randomly assigned to one of the six groups between Jan 9 and Sept 20, 2017; 542 were included in the final analysis of the primary endpoint (86-93 per group']","['valent or 13-valent pneumococcal conjugate vaccine', 'pneumococcal conjugate vaccine (PCV', 'PCV10 or PCV13', 'ten-valent (PCV10) and 13-valent (PCV13) PCVs']","['84 serious adverse events', 'geometric mean concentrations (GMCs) of serotype-specific IgG 1 month', 'GMC ratio', 'Immunogenicity', 'ratio of GMCs']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': '10-valent pneumococcal conjugate vaccine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",600.0,0.279769,84 serious adverse events were reported in 72 (12%) of 600 participants.,"[{'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa. Electronic address: madhis@rmpru.co.za.'}, {'ForeName': 'Eleonora Aml', 'Initials': 'EA', 'LastName': 'Mutsaerts', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Welekazi', 'Initials': 'W', 'LastName': 'Boyce', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Sutika', 'Initials': 'S', 'LastName': 'Bhikha', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Benit T', 'Initials': 'BT', 'LastName': 'Ikulinda', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Nana', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moultrie', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Roalfe', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Dorfman', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30289-9']
2803,32858033,A Randomized Placebo-Controlled Pilot Trial of Early Targeted Non-Steroidal Anti-Inflammatory Drugs in Preterm Infants with a Patent Ductus Arteriosus.,"OBJECTIVE


To establish the feasibility of a future large randomized trial to compare early treatment with non-steroidal anti-inflammatory drugs (NSAIDs) versus awaiting spontaneous PDA closure.
STUDY DESIGN


Preterm infants <29 weeks gestation with a PDA diameter >1.5 mm and <72 hours after birth were randomised to NSAID versus placebo. No open label NSAID treatment was allowed in either arm, but all infants with PDA volume load received supportive management including optimization of airway pressure, careful fluid management and diuretics as required. The pilot outcomes were recruitment rate and incidence of open label treatment. Secondary clinical outcomes included chronic lung disease or death, the planned primary outcome for a future large trial.
RESULTS


Overall, 54% of approached parents consented to the study. The median recruitment rate was 3 infants/month and 72 infants were randomized. One patient in each arm received open label treatment. PDA closure rates were 74% (NSAID) versus 30% (placebo) but this did not lead to significant changes in clinical outcomes.
CONCLUSION


This pilot trial showed that recruitment of over half of eligible infants with low incidence of open label treatment is feasible. PDA closure rates and clinical outcomes were similar to those reported in previous PDA trials.",2020,"PDA closure rates were 74% (NSAID) versus 30% (placebo) but this did not lead to significant changes in clinical outcomes.
","['Preterm infants <29 weeks gestation with a PDA diameter >1.5 mm and <72 hours after birth', 'Preterm Infants with a Patent Ductus Arteriosus']","['NSAID versus placebo', 'open label treatment', 'Steroidal Anti-Inflammatory Drugs', 'Placebo', 'non-steroidal anti-inflammatory drugs (NSAIDs']","['PDA closure rates and clinical outcomes', 'median recruitment rate', 'PDA closure rates', 'rate and incidence of open label treatment', 'chronic lung disease or death']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.22599,"PDA closure rates were 74% (NSAID) versus 30% (placebo) but this did not lead to significant changes in clinical outcomes.
","[{'ForeName': 'Koert', 'Initials': 'K', 'LastName': 'de Waal', 'Affiliation': ""Department of Neonatology, John Hunter Children's Hospital and University of Newcastle, NSW, Australia. Electronic address: koert.dewaal@health.nsw.gov.au.""}, {'ForeName': 'Nilkant', 'Initials': 'N', 'LastName': 'Phad', 'Affiliation': ""Department of Neonatology, John Hunter Children's Hospital and University of Newcastle, NSW, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stubbs', 'Affiliation': ""Department of Neonatology, John Hunter Children's Hospital and University of Newcastle, NSW, Australia.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, NSW, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kluckow', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, NSW, Australia.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.062']
2804,32858063,Dietary nutrient intake and progression to late age-related macular degeneration in the Age-Related Eye Disease Studies 1 and 2.,"PURPOSE


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


Post hoc analysis of two controlled clinical trial cohorts: Age-Related Eye Disease Study (AREDS; recruitment 1992-8) and AREDS2 (recruitment 2006-8).
PARTICIPANTS


Eyes with no late AMD at baseline in AREDS participants (n=4,504) and AREDS2 participants (n=3,738): total of 14,135 eyes. Mean age was 71.0 years (SD 6.7); 56.5% were female.
METHODS


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


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


Over median follow-up of 10.2 years, of the 14,135 eyes, 32.7% progressed to late AMD. For nine nutrients, intake quintiles 4 or 5 (versus 1) were significantly (P≤0.0005) associated with decreased risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol. For three nutrients, quintiles 4 or 5 were significantly associated with increased risk: saturated fatty acid, monounsaturated fatty acid, and oleic acid. Similar results were observed for GA. Regarding neovascular AMD, nine nutrients were nominally associated with decreased risk (vitamins A and B6, β-carotene, lutein/zeaxanthin, magnesium, copper, docosahexaenoic acid, omega-3 fatty acid, and alcohol) and three with increased risk (saturated fatty acid, monounsaturated fatty acid, and oleic acid). In separate analyses (n=5,399 eyes of 3,164 AREDS participants), 12 nutrients were nominally associated with decreased risk of large drusen.
CONCLUSIONS


Higher dietary intake of multiple nutrients, including minerals, vitamins, and carotenoids, is associated with decreased risk of progression to late AMD. These associations are stronger for GA, for which no treatments are available, than for neovascular AMD. The same nutrients tend also to have protective associations against large drusen development. Strong genetic interactions exist for some nutrient-genotype combinations, particularly omega-3 fatty acids and CFH. These data may justify further research into underlying mechanisms and randomized trials of supplementation.",2020,"For nine nutrients, intake quintiles 4 or 5 (versus 1) were significantly (P≤0.0005) associated with decreased risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol.","['Mean age was 71.0 years (SD 6.7); 56.5% were female', 'two controlled clinical trial cohorts: Age-Related Eye Disease Study (AREDS; recruitment 1992-8) and AREDS2 (recruitment 2006-8', 'Eyes with no late AMD at baseline in AREDS participants (n=4,504) and AREDS2 participants (n=3,738): total of 14,135 eyes', 'Fundus photographs were collected at annual study visits and graded centrally for late AMD']",[],"['risk of large drusen', 'Progression to late AMD, geographic atrophy (GA), neovascular AMD, and (separate analyses) large drusen', 'risk (vitamins A and B6, β-carotene, lutein/zeaxanthin, magnesium, copper, docosahexaenoic acid, omega-3 fatty acid, and alcohol', 'risk: saturated fatty acid, monounsaturated fatty acid, and oleic acid', 'risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456592', 'cui_str': '1992'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C2929534', 'cui_str': 'Lutein / zeaxanthin'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0178638', 'cui_str': 'Folate'}]",9.0,0.0446104,"For nine nutrients, intake quintiles 4 or 5 (versus 1) were significantly (P≤0.0005) associated with decreased risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mares', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Company LLC, Rockville, MD, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaroop', 'Affiliation': 'Neurobiology-Neurodegeneration & Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, USA. Electronic address: echew@nei.nih.gov.'}, {'ForeName': 'Tiarnan D L', 'Initials': 'TDL', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, USA. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.08.018']
2805,32853709,"Topical betamethasone valerate as a prophylactic agent to prevent acute radiation dermatitis in head and neck malignancies: a randomised, open-label, phase 3 trial.","PURPOSE


We assessed the role of topical betamethasone as a prophylactic agent in patients receiving radiation for head and neck malignancies.
PATIENTS AND METHODS


This randomised, open- label, phase 3 trial was done in a single research institute. Patients receiving curative radiation for head and neck cancer were randomised into 2 groups of 75 each by computer-generated permuted block random assignment. Patients in test arm applied 0.1% topical betamethasone valerate cream once a day, after radiation. Patients in the control arm received best supportive care. RTOG acute toxicity grading scale was used to assess radiation dermatitis after every 5 th  fraction till completion and at 2 weeks post treatment. Primary outcome in both arms was the proportion of patients who developed grade 2 and 3 acute skin reaction. The trial is registered at Central Trial Registry of India(CTRI), No: CTRI/2017/04/008298.
RESULTS


Between April 15 2017 and October 30 2018,150 patients were randomised into the study, 75 in each arm.14 and 15 patients in test and control arm respectively did not complete the intended treatment. As per intention to treat analysis, 25/75 patients (33.3%) and 38/75 patients (50.7%) developed Grade 2 and above radiation dermatitis in the test and control arm respectively, (absolute difference 17.4%, 95% CI: 4 - 30; p = 0.032).15/75 patients (20%) developed Grade 3 reactions in the test arm compared to 18/75 (24%) in the control arm (absolute difference 4%, 95% CI: 7 -15; p = 0.554).
CONCLUSION


Although prophylactic use of betamethasone significantly reduced the composite outcome of the proportion of patients developing grade 2 and Grade 3 radiation dermatitis it did not reduce the proportion of patients developing the clinically significant outcome of Grade 3 radiation dermatitis.",2020,Although prophylactic use of betamethasone significantly reduced the composite outcome of the proportion of patients developing grade 2 and Grade 3 radiation dermatitis it did not reduce the proportion of patients developing the clinically significant outcome of Grade 3 radiation dermatitis.,"['Between April 15 2017 and October 30 2018,150 patients', 'Patients receiving curative radiation for head and neck cancer', 'patients receiving radiation for head and neck malignancies', 'head and neck malignancies']","['supportive care', 'topical betamethasone valerate cream', 'Topical betamethasone valerate', 'betamethasone', 'topical betamethasone']","['Grade 3 reactions', 'RTOG acute toxicity grading scale', 'Grade 2 and above radiation dermatitis', 'acute radiation dermatitis', 'radiation dermatitis', 'proportion of patients who developed grade 2 and 3 acute skin reaction']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0750848', 'cui_str': 'Betamethasone valerate'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}]",,0.113833,Although prophylactic use of betamethasone significantly reduced the composite outcome of the proportion of patients developing grade 2 and Grade 3 radiation dermatitis it did not reduce the proportion of patients developing the clinically significant outcome of Grade 3 radiation dermatitis.,"[{'ForeName': 'Abhilash', 'Initials': 'A', 'LastName': 'Menon', 'Affiliation': 'Junior Resident Department of Radiation Oncology, RCC, JIPMER, Puducherry - 605006.'}, {'ForeName': 'Shyama', 'Initials': 'S', 'LastName': 'Prem S', 'Affiliation': ''}, {'ForeName': 'Dr Rashmi', 'Initials': 'DR', 'LastName': 'Kumari', 'Affiliation': 'Department of Dermatology and STD, RCC, JIPMER, Puducherry - 605006.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.08.040']
2806,32854060,Anti-caries effect of fluoridated milk-based drink consumed by older adults on an in vitro root caries experimental model.,"OBJECTIVE


This study aimed to evaluate the anti-caries effect of a fluoridated milk-based drink on a root caries model by assessing mineral loss and both biofilm microbial viability and acidogenicity under increasing concentrations of fluoride supplementation.
DESIGN


Streptococcus mutans UA159 biofilms were grown on root dentin slabs for five days. The slabs were randomly assigned to following groups: milk-based drink (G1) and milk-based drink supplemented with 5-ppm NaF (G2), 10 ppm NaF (G3), and 20 ppm NaF (G4). A 10% sucrose and 0.9% NaCl solution were used as positive and negative-caries controls, respectively. Slabs/biofilms were exposed to the different treatments 3 times/day for 5 min. To estimate biofilm acidogenicity, the pH of the spent media was serially measured to calculate the area above the curve. Viable bacteria and dentin demineralization were assessed after the experimental phase. Results were compared using ANOVA followed by the Tukey test.
RESULTS


G1 exhibited slightly lower acidogenicity than the positive caries control group (p < 0.05). G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink. The lowest acidogenicity was found in G4 (p < 0.05). Fluoride-supplemented milk-based drinks (G2, G3, and G4) resulted in lower bacterial counts (p < 0.05) and induced lower demineralization (p < 0.05) than the positive caries control and non-supplemented milk-beverage (G1). There was a dose-dependent inhibition of demineralization with fluoride-supplemented milk-based drinks.
CONCLUSIONS


Fluoride supplementation of a milk-based drink for older adults may reduce its cariogenicity in root dentin.",2020,"G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink.","['older adults on an in vitro root caries experimental model', 'older adults']","['Fluoride supplementation', 'Fluoride-supplemented milk-based drinks (G2, G3, and G4', 'fluoridated milk-based drink', 'milk-based drink (G1) and milk-based drink supplemented with 5-ppm NaF (G2), 10\u202fppm NaF (G3), and 20\u202fppm NaF (G4']","['lower bacterial counts', 'Viable bacteria and dentin demineralization', 'acidogenicity', 'lowest acidogenicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0162644', 'cui_str': 'Root caries'}, {'cui': 'C0086272', 'cui_str': 'Experimental Models'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3541971', 'cui_str': 'Fluoride supplement'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}]",,0.0182389,"G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink.","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Castro', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation and Health Sciences Faculty, School of Dentistry, University of Talca, 1 Poniente 1141, Talca, Chile.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maltz', 'Affiliation': 'Preventive and Community Dentistry Department, Dental School, Federal University of Rio Grande do Sul (UFRGS), Rua Ramiro Barcelos 2492, Porto Alegre, Brazil. Electronic address: marisa.maltz@gmail.com.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Arthur', 'Affiliation': 'Preventive and Community Dentistry Department, Dental School, Federal University of Rio Grande do Sul (UFRGS), Rua Ramiro Barcelos 2492, Porto Alegre, Brazil.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Giacaman', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation and Health Sciences Faculty, School of Dentistry, University of Talca, 1 Poniente 1141, Talca, Chile.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104878']
2807,32854145,BILITE: A Bayesian randomized phase II design for immunotherapy by jointly modeling the longitudinal immune response and time-to-event efficacy.,"Immunotherapy-treatments that target a patient's immune system-has attracted considerable attention in cancer research. Its recent success has led to generation of novel immunotherapeutic agents that need to be evaluated in clinical trials. Two unique features of immunotherapy are the immune response and the fact that some patients may achieve long-term durable response. In this article, we propose a two-arm Bayesian adaptive randomized phase II clinical trial design for immunotherapy that jointly models the longitudinal immune response and time-to-event efficacy (BILITE), with a fraction of patients assumed to be cured by the treatment. The longitudinal immune response is modeled using hierarchical nonlinear mixed-effects models with possibly different trajectory patterns for the cured and susceptible groups. Conditional on the immune response trajectory, the time-to-event efficacy data for patients in the susceptible group is modeled via a time-dependent Cox-type regression model. We quantify the desirability of the treatment using a utility function and propose a two-stage design to adaptively randomize patients to treatments and make treatment recommendations at the end of the trial. Simulation studies show that compared with a conventional design that ignores the immune response, BILITE yields superior operating characteristics in terms of the ability to identify promising agents and terminate the trial early for futility.",2020,"Simulation studies show that compared with a conventional design that ignores the immune response, BILITE yields superior operating characteristics in terms of the ability to identify promising agents and terminate the trial early for futility.",[],[],[],[],[],[],,0.0406347,"Simulation studies show that compared with a conventional design that ignores the immune response, BILITE yields superior operating characteristics in terms of the ability to identify promising agents and terminate the trial early for futility.","[{'ForeName': 'Beibei', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Department of Experimental Statistics, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Biostatistics, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}]",Statistics in medicine,['10.1002/sim.8733']
2808,32854150,Soybean Oil Lipid Minimization for Prevention of Intestinal Failure Associated Liver Disease in Late Preterm and Term Infants with Gastro-Intestinal Surgical Disorders.,"OBJECTIVE


Intestinal failure associated liver disease (IFALD), a multi-factorial disease, is common among infants with gastrointestinal surgical disorders (GISDs). Prolonged soy-based intravenous lipid emulsion (S-ILE) intake is associated with IFALD, but preventive studies of limiting S-ILE have been inconclusive. Furthermore, double-blind, randomized preventive trial (DBRPT) of S-ILE intake has not been performed in infants with GISDs. Our objective was to compare the effect of 1g/kg/day versus 2g/kg/day S-ILE intake for 6 weeks on the incidence of IFALD and the rate of rise of direct bilirubin (DB) in ≥ 34 weeks gestational age (GA) infants with GISDs.
STUDY DESIGN


A DBRPT was conducted in ≥ 34 weeks GA infants with GISDs admitted to the NICU within 72 hours after birth. Infants were randomized in a 1:1 ratio to receive either 1g/kg/day or 2g/kg/day of S-ILE for 6 weeks. IFALD was defined as DB ≥ 2mg/dL.
RESULTS


40 infants were studied. The two groups were similar in clinical characteristics except for GA and blood group incompatibility. 30% of infants in each group developed IFALD (P = 0.94). However, infants in 1g/kg/day S-ILE group (n = 20) had a lower rate of rise of DB compared to infants in 2g/kg/day S-ILE group (n = 20).
CONCLUSIONS


Reducing S-ILE intake for 6 weeks in ≥ 34 weeks GA infants with GISD may not prevent IFALD. The extrapolated data on the rate of rise of DB suggests a possible risk of earlier development of IFALD with S-ILE intake of 2g/kg/day as compared to 1g/kg/day beyond the study period of 6 weeks. This article is protected by copyright. All rights reserved.",2020,30% of infants in each group developed IFALD (P = 0.94).,"['infants with GISDs', '≥ 34 weeks gestational age (GA) infants with GISDs', 'Late Preterm and Term Infants with Gastro-Intestinal Surgical Disorders', 'infants with gastrointestinal surgical disorders (GISDs', '34 weeks GA infants with GISDs admitted to the NICU within 72 hours after birth']","['Soybean Oil Lipid Minimization', 'Prolonged soy-based intravenous lipid emulsion (S-ILE']","['IFALD', 'rate of rise of DB', 'incidence of IFALD and the rate of rise of direct bilirubin (DB']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015667', 'cui_str': 'Lipid Emulsions, Intravenous'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",40.0,0.184114,30% of infants in each group developed IFALD (P = 0.94).,"[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Hennepin Healthcare Inc., Minneapolis, Minnesota, USA.'}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Sanjiv B', 'Initials': 'SB', 'LastName': 'Amin', 'Affiliation': 'University of New Mexico, Albuquerque, New Mexico, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2004']
2809,32854153,Integrating high intensity interval training into the workplace: The Work-HIIT pilot RCT.,"The purpose of this study was to assess the feasibility and preliminary efficacy of a high intensity interval training (HIIT) intervention integrated into the workplace on physical and mental health outcomes in a sample of adults. The Work-HIIT intervention was evaluated at the University of Newcastle (March-July, 2019). University employees (18+yrs) who self-identified as predominantly sedentary at work (n=47, 43.0 ± 10.7yrs; 41 female) were recruited, screened and randomized after baseline assessments into Work-HIIT (n=24) or wait-list control (n=23) conditions. Participants were asked to attend 2-3 researcher-facilitated HIIT sessions/week (weeks 1-8). Sessions included a 2-minute gross-motor warm-up, followed by various combinations of aerobic and muscular fitness exercises lasting 8-minutes (using 30:30 second work: rest intervals). Program feasibility was assessed using measures of satisfaction, compliance, adherence, fidelity, and retention. Physiological and psychological outcomes were measured at baseline and 9-weeks. Feasibility data was investigated using descriptive statistics and efficacy outcomes determined using linear mixed models and Cohen's d effect sizes. Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/week and averaged 85.9%HR max  across all sessions (including rest and work intervals). Small-to-medium positive effects resulted for cardio-respiratory fitness [+2.9 laps, 95%CI (-4.19-10.14); d=0.34] and work productivity [+0.26, d=0.47]. Large positive effects resulted for muscular fitness [push-ups +3.5, d=0.95; standing jump +10.1cm, d=1.12]; HIIT self-efficacy [+16.53, d=1.57]; sleep [weekday +0.76hrs, d=1.05]; and autonomous motivation [+0.23, d=0.76]. This study supports the feasibility and preliminary efficacy of facilitator-led Work-HIIT as a time-efficient, enjoyable, and convenient workplace exercise option for adults.",2020,Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/week and averaged 85.9%HR max  across all sessions (including rest and work intervals).,"['adults', 'a sample of adults', 'University employees (18+yrs) who self-identified as predominantly sedentary at work (n=47, 43.0 ± 10.7yrs; 41 female']","['wait-list control', 'high intensity interval training (HIIT) intervention', 'facilitator-led Work-HIIT', '2-minute gross-motor warm-up, followed by various combinations of aerobic and muscular fitness exercises lasting 8-minutes']","['cardio-respiratory fitness', 'physical and mental health outcomes', 'satisfaction, compliance, adherence, fidelity, and retention', 'muscular fitness', 'Physiological and psychological outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3540029', 'cui_str': 'various combinations'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.0516742,Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/week and averaged 85.9%HR max  across all sessions (including rest and work intervals).,"[{'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Eather', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Babic', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Riley', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Harris', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'University of British Columbia, British Columbia, Canada.'}, {'ForeName': 'Mikeelie', 'Initials': 'M', 'LastName': 'Jeffs', 'Affiliation': 'Faculty of Education and Arts, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Barclay', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13811']
2810,32854200,Feasibility and Clinical Usefulness of the Unified Protocol in Online Group Format for Bariatric Surgery Candidates: Study Protocol for a Multiple Baseline Experimental Design.,"Obesity is currently becoming a serious global public health problem due to its high prevalence and continuous increase. This condition is associated with different physical and mental health problems. The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results. The present study aims to explore the feasibility and clinical usefulness of the Unified Protocol, a transdiagnostic emotion regulation-based intervention, delivered in an online group format to patients with emotional disorder diagnosis or symptoms, who are waiting for bariatric surgery. We will conduct a pilot study with a repeated single-case experimental design (multiple baseline design) in a public mental health service. The sample will consist of 60 participants, who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days before the intervention. Diagnostic criteria, symptomatology and body mass index are the primary outcome measures, and we will include affectivity, personality, quality of life, body image, eating behavior and surgical complications like secondary measures. An analysis of treatment satisfaction will be also performed. Assessment points will include pre-treatment, baseline, treatment, post-treatment, and follow-ups every three months until two years after post-treatment. The results obtained in this study may have important clinical, social and economic implications for public mental health.",2020,"The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results.","['patients with emotional disorder diagnosis or symptoms, who are waiting for bariatric surgery', 'public mental health service', '60 participants']",['transdiagnostic emotion regulation-based intervention'],"['affectivity, personality, quality of life, body image, eating behavior and surgical complications like secondary measures', 'emotional disorders (anxiety, depression and related disorders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",60.0,0.0788091,"The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Quilez-Orden', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, 44003 Teruel, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ferreres-Galán', 'Affiliation': 'Mental Health Unit of the Regional Hospital of Vinaròs, 12500 Castellón, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Osma', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, 44003 Teruel, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176155']
2811,32854681,Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery).,"BACKGROUND


Open surgical repair (OSR) for thoracoabdominal aortic aneurysms (TAA) is associated with a high pulmonary and renal morbidity rate. Ischemic preconditioning (IPC) is a mechanism of protection against the deleterious effects of ischemia-reperfusion. To our knowledge IPC has never been tested during OSR for TAA.
METHODS


The primary objective of the study is to evaluate the efficacy of IPC during OSR for TAA with respect to acute kidney injury (AKI) according to KDIGO and pneumonia/prolonged ventilation-time during the first 8 postoperative days. The secondary objectives are to compare both arms with respect to cardiac complications within 48 h, renal and pulmonary complications within 21 days and mortality at 60 days. To assess the efficacy of IPC with respect to pulmonary and renal morbidity, a cox model for competing risks will be used. Assuming that the event occurs among 36% of the patients when no IPC is performed, the allocation of 55 patients to each arm should allow detecting a hazard ratio of at least 2.75 with a power of 80% when admitting 5% for an error of first kind. This means that 110 patients, enrolled in this multicenter study, may be randomised within 36 months of the first randomization. Randomization will be performed to allocate patients either to surgery with preconditioning before aortic cross clamping (Arm 1) or to surgery without preconditioning before aortic cross clamping (Arm 2). Randomization takes place during the intervention after intravenous injection of heparin, or after the start of femoral assistance. The procedure for IPC will be a supra-visceral thoracic aortic cross clamping for 5 min followed by an unclamping period of 5 min. This procedure will be repeated twice before starting thoracic aortic cross clamping needed to perform surgery.
CONCLUSIONS


Our hypothesis is that ischemic preconditioning could reduce clinical morbidity and the incidence of lung damage associated with supra-visceral aortic clamping.
TRIAL REGISTRATION


EPICATAStudy registered in ClinicalTrial.gov / number: NCT03718312 on Oct.24.2018 URL number.",2020,"To assess the efficacy of IPC with respect to pulmonary and renal morbidity, a cox model for competing risks will be used.","['110 patients', 'thoracoabdominal aortic aneurysm ', 'open ThoracoAbdominal Aortic surgery']","['Ischemic preconditioning (IPC', 'supra-visceral aortic ischemic preconditioning', 'IPC', 'surgery with preconditioning before aortic cross clamping (Arm 1) or to surgery without preconditioning before aortic cross clamping', 'Ischemic PreConditioning', 'Open surgical repair (OSR', 'heparin']","['morbidity and mortality', 'clinical morbidity', 'cardiac complications within 48\u2009h, renal and pulmonary complications']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340630', 'cui_str': 'Thoracoabdominal aortic aneurysm'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444467', 'cui_str': 'Thoracoabdominal'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}]","[{'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.126403,"To assess the efficacy of IPC with respect to pulmonary and renal morbidity, a cox model for competing risks will be used.","[{'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Palmier', 'Affiliation': 'Department of vascular surgery and Inserm U1096, Rouen University Hospital, 1 rue de Germont, 76031, Rouen Cedex, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Bubenheim', 'Affiliation': 'Department of Clinical research and Innovation, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Chiche', 'Affiliation': 'Department of vascular surgery, Pitié-Salpétrière University Hospital, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Chaufour', 'Affiliation': 'Department of vascular surgery, Rangueil University Hospital, Toulouse, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Koskas', 'Affiliation': 'Department of vascular surgery, Pitié-Salpétrière University Hospital, Paris, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Fadel', 'Affiliation': 'Centre Chirurgical Marie Lannelongue, Le Plessis Robinson, France.'}, {'ForeName': 'Pierre Edouard', 'Initials': 'PE', 'LastName': 'Magnan', 'Affiliation': 'Department of vascular surgery, La Timone University Hospital, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ducasse', 'Affiliation': 'Department of vascular surgery, Pellegrin University Hospital, Bordeaux, France.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Chakfe', 'Affiliation': 'Department of vascular surgery, Nouvel Hopital Civil, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Steinmetz', 'Affiliation': 'Department of vascular surgery, Dijon University Hospital, Dijon, France.'}, {'ForeName': 'Marie Melody', 'Initials': 'MM', 'LastName': 'Dusseaux', 'Affiliation': 'Department of anesthesia, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Ricco', 'Affiliation': 'Department of Clinical Research and Innovation, University Hospital, Poitiers, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Plissonnier', 'Affiliation': 'Department of vascular surgery and Inserm U1096, Rouen University Hospital, 1 rue de Germont, 76031, Rouen Cedex, France. didier.plissonnier@gmail.com.'}]",BMC surgery,['10.1186/s12893-020-00851-3']
2812,32854688,"Effect of high-intensity interval training on cardiorespiratory fitness, physical activity and body composition in people with schizophrenia: a randomized controlled trial.","BACKGROUND


Exercise may improve cardiorespiratory fitness in people with schizophrenia, however, possible condition-specific cardiorespiratory disadvantages, a scarcity of methodologically sound studies, and conflicting results raise questions about the effect of exercise on maximal oxygen uptake (VO 2max ) in this group. The primary aim of this study, therefore, was to investigate the effect of high-intensity interval training on VO 2max  in people with schizophrenia. Second, we sought to determine whether the intervention would have an effect on general physical activity (PA) level and body composition.
METHODS


Eighty-two patients with schizophrenia were randomly assigned to supervised high-intensity interval training or computer gaming skills training, performed twice a week for 12 weeks. Oxygen uptake was measured directly, during a maximum exercise session on a treadmill. PA level were assessed using ActiGraph accelerometer, and body composition was assessed by bioelectrical impedance. Differences between groups were assessed by analysis of variance using a univariate general linear model.
RESULTS


There were no significant differences between the groups on any of the cardiorespiratory variables neither at baseline nor after the program. There were also no significant within-group differences in any of the cardiorespiratory fitness variables between the baseline and post-program time points, despite that 61% of the participants performing high-intensity interval training showed a significant increase in workload on the treadmill. However, 47% of the participants in the high-intensity interval training group had a ≥ 5% increase in VO 2max . Participants supervised by mental health care providers with PA competence (e.g. rehabilitation center staff, sport scientist, physical trainer) had a much larger increase in VO 2max  compared to participants supervised by mental health workers without such competence, and when adding PA competence to the model, the intervention group increased VO 2max  significantly compared to the comparison group. The intervention had no significant effect on PA level or body composition.
CONCLUSIONS


The intervention did not improve VO 2max , PA level or body composition but succeeded in increasing workload on the treadmill. With regard to VO 2max , approximately half of the patients may be considered responders.
TRIAL REGISTRATION


ClinicalTrials.gov ; NCT02205684 , registered July 2014.",2020,There were no significant differences between the groups on any of the cardiorespiratory variables neither at baseline nor after the program.,"['Participants supervised by mental health care providers with PA competence (e.g. rehabilitation center staff, sport scientist, physical trainer', 'people with schizophrenia', 'Eighty-two patients with schizophrenia']","['supervised high-intensity interval training or computer gaming skills training', 'high-intensity interval training']","['PA level', 'cardiorespiratory fitness, physical activity and body composition', 'workload on the treadmill', 'ActiGraph accelerometer, and body composition', 'cardiorespiratory fitness', 'Oxygen uptake', 'VO 2max ', 'cardiorespiratory fitness variables', 'maximal oxygen uptake (VO 2max ', 'VO 2max', 'general physical activity (PA) level and body composition', 'VO 2max , PA level or body composition', 'PA level or body composition']","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0402112', 'cui_str': 'Scientist'}, {'cui': 'C0335107', 'cui_str': 'Physical trainer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",82.0,0.0884163,There were no significant differences between the groups on any of the cardiorespiratory variables neither at baseline nor after the program.,"[{'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, PO box 235, 3603, Kongsberg, Horten, Norway. eivind.andersen@usn.no.'}, {'ForeName': 'Gry', 'Initials': 'G', 'LastName': 'Bang-Kittilsen', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Therese Torgersen', 'Initials': 'TT', 'LastName': 'Bigseth', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Egeland', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Tom Langerud', 'Initials': 'TL', 'LastName': 'Holmen', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Egil Wilhelm', 'Initials': 'EW', 'LastName': 'Martinsen', 'Affiliation': 'Clinic Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Stensrud', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'John Abel', 'Initials': 'JA', 'LastName': 'Engh', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}]",BMC psychiatry,['10.1186/s12888-020-02827-2']
2813,32854693,A randomized trial on the effects of root resorption after orthodontic treatment using pulsating force.,"BACKGROUND


An orthodontic device that moves teeth with pulsating force was invented and underwent a single center, controlled, clinical trial to test its safety and efficacy for treatment. The device has a custom-made thermo-plastic mouthpiece which fits over the teeth with an inflatable silicone element. A console that measures and controls the pulsating force level in real-time controls the air pressure that delivers a pulsating force. In this study, the effect of the device on root resorption during orthodontic treatment was evaluated using 3D cone beam computed tomography and compared with a control group of patients who received Invisalign treatment.
METHODS


Twenty-eight subjects were enrolled in the investigational arm and 15 in the control group. Subjects were followed until the average score of the mandibular and maxillary teeth achieved a Little's Irregularity Index of 1.5 mm or less.
RESULTS


There were no adverse events reported throughout the study for either treatment arm. No clinically significant root resorption was observed for either group. The investigational device did not cause root resorption greater than the control group. Both devices produced a safety profile compared to current orthodontic techniques.
CONCLUSION


The investigational device did not produce more root resorption than similar conventional orthodontic appliances.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03421886 . Registered 12 January 2018 - Retrospectively registered.",2020,The investigational device did not cause root resorption greater than the control group.,"['Registered 12 January 2018 - Retrospectively registered', 'Twenty-eight subjects were enrolled in the investigational arm and 15 in the control group']",['Invisalign treatment'],"['root resorption', 'adverse events']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4704905', 'cui_str': 'Invisalign'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.0624206,The investigational device did not cause root resorption greater than the control group.,"[{'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Univeristy of Alabama at Birmingham, Room 305, School of Dentistry Building, 1919 7th Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Ejvis', 'Initials': 'E', 'LastName': 'Lamani', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Univeristy of Alabama at Birmingham, Room 305, School of Dentistry Building, 1919 7th Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Terpsithea', 'Initials': 'T', 'LastName': 'Christou', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Univeristy of Alabama at Birmingham, Room 305, School of Dentistry Building, 1919 7th Avenue South, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Chung How', 'Initials': 'CH', 'LastName': 'Kau', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Univeristy of Alabama at Birmingham, Room 305, School of Dentistry Building, 1919 7th Avenue South, Birmingham, AL, 35294, USA. ckau@uab.edu.'}]",BMC oral health,['10.1186/s12903-020-01226-z']
2814,32854734,Engaging parents in digital sexual and reproductive health education: evidence from the JACK trial.,"BACKGROUND


Research evidence and international policy highlight the central role that parents play in promoting positive sexual behaviour and outcomes in their children, however they can be difficult to engage in sexual and reproductive health (SRH) education programmes. Digital health promotion that uses online and mobile technologies (OMTs) to promote parent-child communication may offer an innovative solution to reach parents, however, few programmes have used OMTs to involve parents in SRH, and none have reported lessons learned in relation to optimising engagement. This study addresses this gap in the literature by reporting acceptability and feasibility of using OMTs to engage parents in SRH education. Findings will be relevant for those wishing to develop and implement digital SRH programmes with parents internationally.
METHODS


The Jack Trial is a UK-wide cluster randomised controlled trial recruiting over 8000 adolescents from 66 socially and religiously diverse post-primary schools. An embedded mixed-methods process evaluation explored user engagement with parent components of the If I Were Jack SRH education programme, which include online animated films and a parent-teen homework exercise.
RESULTS


A total of 109 adolescents, teachers, parents and SRH policy experts took part in semi-structured interviews and focus groups, 134 parents responded to an online survey, and 3179 adolescents completed a programme engagement and satisfaction questionnaire. Parents who accessed the materials were positive about them; 87% rated them as 'good or excellent' and 67% said they helped them have conversations with their child about SRH. Web analytics revealed that 27% of contacted parents accessed the digital materials, with 9% viewing the animated films. Only 38% of teachers implemented the homework exercise, mainly because they assumed that students would not complete it or it might result in backlash from parents.
CONCLUSIONS


While digital parental materials show promise for engaging parents in SRH education, this study suggests that in order to optimise engagement, parental components that give parents the necessary skills to have conversations with their children about sex should be coupled with efforts to increase school and teacher confidence to communicate with parents on sensitive topics.
TRIAL REGISTRATION


ISRCTN99459996 .",2020,"An embedded mixed-methods process evaluation explored user engagement with parent components of the If I Were Jack SRH education programme, which include online animated films and a parent-teen homework exercise.
","['109 adolescents, teachers, parents and SRH policy experts took part in semi-structured interviews and focus groups, 134 parents responded to an online survey, and 3179 adolescents completed a programme engagement and satisfaction questionnaire', '8000 adolescents from 66 socially and religiously diverse post-primary schools', 'Engaging parents in digital sexual and reproductive health education']",['OMTs'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3840857', 'cui_str': '8000'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]",[],8000.0,0.111774,"An embedded mixed-methods process evaluation explored user engagement with parent components of the If I Were Jack SRH education programme, which include online animated films and a parent-teen homework exercise.
","[{'ForeName': 'Áine', 'Initials': 'Á', 'LastName': 'Aventin', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK. a.aventin@qub.ac.uk.""}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Gough', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McShane', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gillespie', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': ""O'Hare"", 'Affiliation': ""School of Social Sciences, Education and Social Work and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Honor', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, Wales, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Univeristy of Glasgow, Glasgow, Scotland, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Department of Public Health Environments and Society, London School of Hygiene and Tropical Medicine, London, England, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Buckley', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, Wales, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lohan', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}]",Reproductive health,['10.1186/s12978-020-00975-y']
2815,32854751,"Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial.","BACKGROUND


The first case of a coronavirus 2019 (COVID-19) infection in a Sri Lankan was reported on March 11, 2020. The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people. This provided a unique opportunity to study the effectiveness of hydroxychloroquine (HCQ) for post-exposure prophylaxis (PEP), while taking stringent, non-pharmacologic, public health measures to prevent spread. Our aim is to study the effectiveness and safety of HCQ for PEP among naval personnel with exposure to COVID-19-positive patients.
METHODS/DESIGN


This is a placebo-controlled, randomized, clinical trial carried out in the naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka. Navy personnel who are exposed to a patient with confirmed COVID-19 infection but test negative for the virus on reverse real-time polymerase chain reaction (rRT-PCR) at recruitment will be randomized, 200 to each arm, to receive HCQ or placebo and monitored for the development of symptoms or rRT-PCR positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus for 14 days.
DISCUSSION


This trial will provide high-quality evidence of the effectiveness and safety of HCQ as PEP for COVID-19. The study design is unique due to the circumstances of the outbreak in a confined area among otherwise healthy adults, at a relatively early stage of its spread.
TRIAL REGISTRATION


Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011 . Registered on 04 May 2020.",2020,The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people.,"['post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka', 'naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka', 'naval personnel with exposure to COVID-19-positive patients']","['Hydroxychloroquine', 'placebo', 'HCQ', 'HCQ or placebo', 'hydroxychloroquine (HCQ']",[],"[{'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.463096,The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people.,"[{'ForeName': 'Madunil A', 'Initials': 'MA', 'LastName': 'Niriella', 'Affiliation': 'Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka. madunil.niriella@kln.ac.lk.'}, {'ForeName': 'Dileepa S', 'Initials': 'DS', 'LastName': 'Ediriweera', 'Affiliation': 'Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Arjuna P', 'Initials': 'AP', 'LastName': 'De Silva', 'Affiliation': 'Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Premarathne', 'Affiliation': 'Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Priyantha', 'Initials': 'P', 'LastName': 'Balasooriya', 'Affiliation': 'Navy Hospital, Welisara, Sri Lanka.'}, {'ForeName': 'Kaluthanthri D', 'Initials': 'KD', 'LastName': 'Duminda', 'Affiliation': 'Army Hospital, Narahenpita, Sri Lanka.'}, {'ForeName': 'Neelika G', 'Initials': 'NG', 'LastName': 'Malavige', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayawardenapura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Kamani', 'Initials': 'K', 'LastName': 'Wanigasuriya', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayawardenapura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Sarath', 'Initials': 'S', 'LastName': 'Lekamwasam', 'Affiliation': 'Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.'}, {'ForeName': 'Senanayake A', 'Initials': 'SA', 'LastName': 'Kularathne', 'Affiliation': 'Faculty of Medicine, University of Peradeniya, Kandy, Sri Lanka.'}, {'ForeName': 'Sisira', 'Initials': 'S', 'LastName': 'Siribaddana', 'Affiliation': 'Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Hithanadura J', 'Initials': 'HJ', 'LastName': 'de Silva', 'Affiliation': 'Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.'}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Jayasinghe', 'Affiliation': 'Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}]",Trials,['10.1186/s13063-020-04659-7']
2816,32854984,Effect of information format on intentions and beliefs regarding diagnostic imaging for non-specific low back pain: A randomised controlled trial in members of the public.,"OBJECTIVE


To evaluate the effects of information format on intentions to request diagnostic imaging for non-specific low back pain in members of the public.
METHODS


We performed a three arm, 1:1:1, superiority randomised trial on members of the public. Participants were randomised to one of the three groups: a Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging). Our primary outcome was intention to request imaging for low back pain.
RESULTS


418 participants were randomised. After reading the leaflet, intention to request imaging (measured on an 11-point scale (0 = definitely would not request to 10 = definitely would request) was lower in the Nudge Leaflet group (mean = 4.6, SD = 3.4) compared with the Standard Care Leaflet group (mean = 5.3, SD = 3.3) and the Neutral Leaflet group (mean = 5.3, SD = 3.0) (adjusted mean difference between Nudge and Neutral, -1.0 points, 95%CI -1.6 to -0.4).
CONCLUSION


Framing information to emphasise potential harms from overdiagnosis reduced intention to request diagnostic imaging for low back pain.
PRACTICE IMPLICATIONS


Nudge leaflets could help clinicians manage patient pressure for unnecessary tests.",2020,"Participants were randomised to one of the three groups: a Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging).","['members of the public', 'non-specific low back pain', 'non-specific low back pain in members of the public', '418 participants were randomised']","['Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging', 'information format']",['intention to request imaging for low back pain'],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",418.0,0.226026,"Participants were randomised to one of the three groups: a Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging).","[{'ForeName': 'Sweekriti', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia. Electronic address: sweekriti.sharma@sydney.edu.au.'}, {'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Traeger', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Copp', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Winton Centre for Risk and Communication, Centre for Mathematical Sciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Faculty of Health Sciences and Medicine, Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.021']
2817,32855054,"Intrathecal Morphine Versus Ketamine in Postoperative Pain After Hysterectomy: Double-Blinded, Randomized Clinical Trial.","PURPOSE


Abdominal hysterectomy is one of the most commonly performed gynecologic surgical procedures and is frequently associated with moderate to severe pain. The present study compared the effects of morphine and ketamine on postoperative analgesia, hemodynamic stability, and postoperative adverse effects in patients who underwent abdominal hysterectomy.
DESIGN


This randomized controlled trial compares the effects of morphine plus adjuvants to those of ketamine plus adjuvants, administered as spinal anesthetic agents in patients who underwent abdominal hysterectomy.
METHODS


Eighty patients were randomly assigned to two different groups: group M (morphine, 40 mcg) and group K (ketamine, 20 mg); the anesthetic agents were combined with equal quantities of other adjuvants. Postoperative analgesia was evaluated by means of a numeric pain rating scale; adverse effects (pruritus, nausea and vomiting, urinary retention, respiratory depression, and changes in bowel habits) at specific postoperative time intervals of T1 (4 hours), T2 (12 hours), and T3 (24 hours) were documented and compared. Hemodynamic stability was assessed intraoperatively.
FINDINGS


Both groups displayed similar patient characteristics, comorbidities, paravertebral block level, and intraoperative hemodynamics. The present study observed a significant difference in postoperative analgesia between the two groups, 12 hours after the surgery, with group M exhibiting better results, compared with group K (P = .004). The pain scores obtained from group K were consistent with the amount of rescue medication (tramadol) administered to the subjects in the group, which showed a concomitant higher consumption of tramadol, compared with group M (42.5 and 71.8 mg in group M and group K, respectively, P = .011). Group M showed a higher incidence of pruritus, changes in bowel habits, and constipation compared with group K.
CONCLUSIONS


Compared with ketamine, intrathecal morphine obtained better postoperative analgesia up to 12 hours after surgery, with a higher incidence of pruritus without any significant change in other variables.",2020,"Group M showed a higher incidence of pruritus, changes in bowel habits, and constipation compared with group K.
CONCLUSIONS


Compared with ketamine, intrathecal morphine obtained better postoperative analgesia up to 12 hours after surgery, with a higher incidence of pruritus without any significant change in other variables.","['Eighty patients', 'patients who underwent abdominal hysterectomy']","['Intrathecal Morphine Versus Ketamine', 'morphine and ketamine', 'tramadol', 'ketamine plus adjuvants', 'group M (morphine, 40 mcg) and group K (ketamine, 20\xa0mg); the anesthetic agents were combined with equal quantities of other adjuvants', 'morphine', 'ketamine, intrathecal morphine']","['postoperative analgesia, hemodynamic stability, and postoperative adverse effects', 'incidence of pruritus, changes in bowel habits, and constipation', 'Postoperative analgesia', 'postoperative analgesia', 'pain scores', 'patient characteristics, comorbidities, paravertebral block level, and intraoperative hemodynamics', 'Hemodynamic stability', 'Postoperative Pain', 'numeric pain rating scale; adverse effects (pruritus, nausea and vomiting, urinary retention, respiratory depression, and changes in bowel habits) at specific postoperative time intervals of T1 (4\xa0hours), T2 (12\xa0hours), and T3 (24\xa0hours']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0441847', 'cui_str': 'Group M'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0441845', 'cui_str': 'Group K'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0278008', 'cui_str': 'Altered bowel function'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",80.0,0.251102,"Group M showed a higher incidence of pruritus, changes in bowel habits, and constipation compared with group K.
CONCLUSIONS


Compared with ketamine, intrathecal morphine obtained better postoperative analgesia up to 12 hours after surgery, with a higher incidence of pruritus without any significant change in other variables.","[{'ForeName': 'Camila A', 'Initials': 'CA', 'LastName': 'Carpi', 'Affiliation': 'Department of Anesthesiology, Hospital São José do Avaí, Itaperuna, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alahyr G G', 'Initials': 'AGG', 'LastName': 'Neto', 'Affiliation': 'Department of Anesthesiology, Hospital São José do Avaí, Itaperuna, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rodrigo A', 'Initials': 'RA', 'LastName': 'Gusmão', 'Affiliation': 'Department of Anesthesiology, Hospital São José do Avaí, Itaperuna, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thaís A M', 'Initials': 'TAM', 'LastName': 'Silva', 'Affiliation': 'Department of Neurotransmitters, Institute of Education and Research, Santa Casa, Belo Horizonte, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Marcus V', 'Initials': 'MV', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurotransmitters, Institute of Education and Research, Santa Casa, Belo Horizonte, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Célio J', 'Initials': 'CJ', 'LastName': 'Castro-Junior', 'Affiliation': 'Department of Neurotransmitters, Institute of Education and Research, Santa Casa, Belo Horizonte, Belo Horizonte, Minas Gerais, Brazil. Electronic address: celiojcjunior@gmail.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.06.013']
2818,32855064,"Corrigendum to ``Live birth rates with a freeze-only strategy versus fresh embryo transfer: secondary analysis of a randomized clinical trial"" [Reproductive BioMedicine Online, Volume 38, Issue 3, March 2019, Pages 387-396].",,2020,,[],['freeze-only strategy versus fresh embryo transfer'],[],[],"[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",[],,0.145478,,"[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam. Electronic address: lanvuong@ump.edu.vn.'}, {'ForeName': 'Toan D', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuong M', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu N A', 'Initials': 'VNA', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'The Robinson Research Institute, School of Medicine, Adelaide, Australia; Fertility SA, Adelaide, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Australia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.011']
2819,32855073,Scapular movement training versus standardized exercises for individuals with chronic shoulder pain: protocol for a randomized controlled trial.,"BACKGROUND


Scapular focused exercise interventions are frequently used to treat individuals with shoulder pain. However, evidence for changes in scapular motion after intervention is limited.
OBJECTIVE


To compare the effects of scapular movement training versus standardized exercises for individuals with shoulder pain.
METHODS


This will be a single-blinded randomized controlled trial. Sixty-four individuals with shoulder pain for at least 3 months, scapular dyskinesis, and a positive scapular assistance test will be randomly allocated to one of two groups: Scapular Movement Training (group 1) and Standardized Exercises (group 2). Group 1 will receive education about scapular position and movement, and be trained to modify the scapular movement pattern. Group 2 will perform stretching and strengthening exercises. Both groups will be treated twice a week for eight weeks. Three-dimensional scapular kinematics and muscle activity of the serratus anterior and upper, middle, and lower trapezius during elevation and lowering of the arm will be assessed at baseline and after 8 weeks of treatment. Pain intensity, function, fear avoidance beliefs, and kinesiophobia will be assessed at baseline and after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment.
CONCLUSIONS


The results of this study may contribute to a better understanding of the efficacy of scapular focused treatments for individuals with shoulder pain.
CLINICAL TRIAL REGISTRATION


NCT03528499.",2020,"The results of this study may contribute to a better understanding of the efficacy of scapular focused treatments for individuals with shoulder pain.
","['Sixty-four individuals with shoulder pain for at least 3 months, scapular dyskinesis, and a positive scapular assistance test', 'individuals with chronic shoulder pain', 'individuals with shoulder pain']","['stretching and strengthening exercises', 'Scapular movement training versus standardized exercises', 'scapular movement training versus standardized exercises', 'Scapular Movement Training (group 1) and Standardized Exercises']","['Pain intensity, function, fear avoidance beliefs, and kinesiophobia']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4523804', 'cui_str': 'Scapular dyskinesis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",64.0,0.154858,"The results of this study may contribute to a better understanding of the efficacy of scapular focused treatments for individuals with shoulder pain.
","[{'ForeName': 'Danilo Harudy', 'Initials': 'DH', 'LastName': 'Kamonseki', 'Affiliation': 'Laboratory of Analysis and Intervention of the Shoulder Complex, Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, SP, Brazil.'}, {'ForeName': 'Melina Nevoeiro', 'Initials': 'MN', 'LastName': 'Haik', 'Affiliation': 'Department of Physical Therapy, Center of Health and Sport Science, Universidade do Estado de Santa Catarina, Florianópolis, SC, Brazil.'}, {'ForeName': 'Paula Rezende', 'Initials': 'PR', 'LastName': 'Camargo', 'Affiliation': 'Laboratory of Analysis and Intervention of the Shoulder Complex, Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, SP, Brazil. Electronic address: prcamargo@ufscar.br.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.08.001']
2820,32855074,"A comparative study of the effects of yoga and clinical Pilates training on walking, cognition, respiratory functions, and quality of life in persons with multiple sclerosis: A quasi-experimental study.","OBJECTIVE


The purpose was to investigate the effects of yoga and clinical Pilates training on walking, respiratory muscle strength, cognition, and quality of life and compare the effects of two popular exercise methods in persons with multiple sclerosis (pwMS).
METHODS


Twenty-eight pwMS (Pilates group = 16, yoga group = 12) received the program once a week for eight weeks in addition to home exercises. At baseline and the end of the training, participants underwent assessments. The outcome measures were walking speed, mobility, balance confidence, respiratory muscle strength, cognition, and quality of life.
RESULTS


Following the program, there was no significant difference in mobility (p = 0.482), perceived walking quality (p = 0.325), respiratory muscle strength (maximum inspiratory pressure: p = 0.263, maximum expiratory pressure: p = 0.866), and cognition (Symbol Digit Modalities Test: p = 0.324, California Verbal Learning Test-II: p = 0.514, Brief Visuospatial Memory Test-Revised: p = 0.279) between the two groups. Improvements were higher in balance confidence (p = 0.006), walking speed (p = 0.004), and quality of life (p = 0.019) in the clinical Pilates group compared to the yoga group.
CONCLUSION


This study showed positive effects in walking and respiratory aspects in pwMS who received yoga and clinical Pilates training. Pilates training was superior in improving walking speed, quality of life, and balance confidence compared to yoga training.",2020,"Following the program, there was no significant difference in mobility (p = 0.482), perceived walking quality (p = 0.325), respiratory muscle strength (maximum inspiratory pressure: p = 0.263, maximum expiratory pressure: p = 0.866), and cognition (Symbol Digit Modalities Test: p = 0.324, California Verbal Learning Test-II:","['Twenty-eight', 'persons with multiple sclerosis (pwMS', 'persons with multiple sclerosis']","['pwMS', 'yoga and clinical Pilates training']","['walking speed, mobility, balance confidence, respiratory muscle strength, cognition, and quality of life', 'walking, respiratory muscle strength, cognition, and quality of life', 'balance confidence', 'walking speed, quality of life, and balance confidence', 'perceived walking quality', 'respiratory muscle strength', 'walking speed', 'walking, cognition, respiratory functions, and quality of life', 'mobility', 'quality of life']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.0168697,"Following the program, there was no significant difference in mobility (p = 0.482), perceived walking quality (p = 0.325), respiratory muscle strength (maximum inspiratory pressure: p = 0.263, maximum expiratory pressure: p = 0.866), and cognition (Symbol Digit Modalities Test: p = 0.324, California Verbal Learning Test-II:","[{'ForeName': 'Zuhal', 'Initials': 'Z', 'LastName': 'Abasıyanık', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylül University, Izmir, Turkey; Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Izmir Katip Celebi University, Izmir, Turkey. Electronic address: zuhalabasiyanik@gmail.com.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Yiğit', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Asiye Tuba', 'Initials': 'AT', 'LastName': 'Özdoğar', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Turhan', 'Initials': 'T', 'LastName': 'Kahraman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Ertekin', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Özakbaş', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Dokuz Eylül University, Izmir, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.013']
2821,32858264,Flattening the Learning Curve: A Video Case-Based Clinical Orientation for a Subspeciality Residency Rotation.,"OBJECTIVE


To determine whether a clinically-focused rotation orientation delivered through e-learning videos would be an effective method to improve residents' clinical knowledge and confidence.
METHODS


A pre-post study design evaluated for change in knowledge and confidence between a control and intervention group of residents assigned to outpatient pediatric endocrinology rotations at two residency programs from July 2017 to March 2019. The intervention group utilized the first morning of the rotation to complete the video curriculum designed to rapidly orient residents to common clinical management tasks in outpatient pediatric endocrinology.
RESULTS


A total of 35 of 41 residents (85%) completed the study [control group: 18/19 (95%); intervention group: 17/22 (77%)]. Score increase from pretest to posttest was significantly higher for intervention group compared to control group (+24.7 % ± 12.1 versus +5.8 % ± 7.9, p<.0001). Confidence increases were significantly higher in the intervention group compared to control group in three of five topics. Two themes illustrated residents' perspectives of this e-learning curriculum: 1) increase in foundational clinical knowledge; and 2) improvement in efficiency of learning and patient care.
CONCLUSIONS


This clinically-focused rotation orientation delivered through e-learning videos was an effective method to improve residents' clinical knowledge, without reliance on faculty to deliver this orientation throughout the academic year. Further studies should be pursued in various settings.",2020,"Score increase from pretest to posttest was significantly higher for intervention group compared to control group (+24.7 % ± 12.1 versus +5.8 % ± 7.9, p<.0001).",['group of residents assigned to outpatient pediatric endocrinology rotations at two residency programs from July 2017 to March 2019'],"['video curriculum designed to rapidly orient residents to common clinical management tasks', 'rotation orientation delivered through e-learning videos', 'control and intervention']",['foundational clinical knowledge; and 2) improvement in efficiency of learning and patient care'],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1658521', 'cui_str': 'Pediatric endocrinology'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0425514,"Score increase from pretest to posttest was significantly higher for intervention group compared to control group (+24.7 % ± 12.1 versus +5.8 % ± 7.9, p<.0001).","[{'ForeName': 'Ranjit V', 'Initials': 'RV', 'LastName': 'Shenoy', 'Affiliation': ""Prior Affiliation: Pediatric Endocrinology Fellow Physician, Division of Pediatric Endocrinology, Department of Pediatrics, UCLA Mattel Children's Hospital. 10833 Le Conte Ave, Los Angeles, CA, 90095, USA; Present Affiliation: Pediatric Endocrinologist, Division of Endocrinology, Diabetes & Metabolism, Nemours Children's Health System. 807 Children's Way, Jacksonville, FL, 32207, USA. Electronic address: Ranjit.Shenoy@nemours.org.""}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Mittelman', 'Affiliation': ""Professor of Pediatrics, Division of Pediatric Endocrinology, UCLA Children's Discovery Institute, David Geffen School of Medicine at UCLA. 10833 Le Conte Ave, Los Angeles, CA, 90095, USA. Electronic address: SMittelman@mednet.ucla.edu.""}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Relan', 'Affiliation': 'Adjunct Professor of Medical Education, David Geffen School of Medicine at UCLA. 10833 Le Conte Ave, Los Angeles, CA, 90095, USA. Electronic address: AnjuRelan@mednet.ucla.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Reh', 'Affiliation': ""Assistant Clinical Professor, Children's Hospital of Orange County (CHOC), University of California (UC) Irvine. 1201 W. La Veta Ave, Orange, CA, USA. Electronic address: CReh@choc.org.""}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': ""Clinical Professor of Pediatrics, Department of Pediatrics, UCLA Mattel Children's Hospital. 10833 Le Conte Ave, Los Angeles, CA, 90095, USA. Electronic address: SYazdani@mednet.ucla.edu.""}]",Academic pediatrics,['10.1016/j.acap.2020.08.013']
2822,32858301,The effects of an intimate partner violence educational intervention on nurses: A quasi-experimental study.,"Nurses play a unique role in responding to the needs of intimate partner violence survivors. However, nurses are not adequately prepared to manage intimate partner violence. This study assessed the effects of intimate partner violence educational interventions on nurses' knowledge, attitudes, and practice. A non-randomized controlled trial was conducted with a convenience sample of nurses (n = 104). Nurses in both the intervention and control groups completed pre- and post-test surveys using the self-reported Physician Readiness to Manage Intimate Partner Violence Survey. An intimate partner violence educational program based on World Health Organization guidelines was administered. The multilevel analysis controlling for pre-test results revealed a significant effect of the intervention on perceived intimate partner violence preparation (p = .000) and knowledge (p = .000), actual knowledge (p = .000), intimate partner violence opinions (attitudes and beliefs) related to preparation (p = .000), legal requirements (p = .00), workplace issues (p = .000), self-efficacy (p = .000), victim understanding (p = .000), victim autonomy (p = .000), and constraints (p = .000). However, the intervention did not affect self-reported practices (p = .583). Intimate partner violence educational programs must be integrated into nursing curricula and in-service training through a system approach.",2020,Nurses in both the intervention and control groups completed pre- and post-test surveys using the self-reported Physician Readiness to Manage Intimate Partner Violence Survey.,"['Intimate partner violence educational programs', 'convenience sample of nurses (n\xa0=\xa0104', 'nurses']","['intimate partner violence educational intervention', 'intimate partner violence educational interventions']","['legal requirements', 'intimate partner violence opinions (attitudes and beliefs', 'victim autonomy', 'perceived intimate partner violence preparation', 'actual knowledge', 'victim understanding', 'self-efficacy']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0137909,Nurses in both the intervention and control groups completed pre- and post-test surveys using the self-reported Physician Readiness to Manage Intimate Partner Violence Survey.,"[{'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Alhalal', 'Affiliation': 'Nursing College, King Saud University, Riyadh, Saudi Arabia. Electronic address: ealhalal@ksu.edu.sa.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102854']
2823,32858333,Experimental sleep restriction increases somatic complaints in healthy adolescents.,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation. In this study, healthy adolescents (n = 30; 14-18yrs) completed a three-week, within-subject cross-over experiment. Following a sleep stabilization week, adolescents were randomized (in counterbalanced order) to five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout."" Somatic complaints were assessed via the Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT) concluding each condition. Adherence to experimental condition was confirmed via actigraphy. Adolescents slept two fewer hours and reported significantly greater frequency and severity of somatic complaints during the Insufficient Sleep (vs. Sufficient Sleep) condition. Restricting sleep opportunity to a level common in adolescence causally increased somatic complaints in otherwise healthy adolescents. Findings support clinical and preventative efforts to address pervasively inadequate sleep in adolescence.",2020,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","['otherwise healthy adolescents', 'healthy adolescents', 'healthy adolescents (n\xa0=\xa030; 14-18yrs']","['Experimental sleep restriction', 'five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout']","[""Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT"", 'Somatic complaints', 'frequency and severity of somatic complaints']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0189992,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA. Electronic address: kendrakrietsch@gmail.com.""}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'King', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Center for Understanding Pediatric Pain (CUPP), Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Christopher.king@cchmc.org.""}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Dean.beebe@cchmc.org.""}]",Sleep medicine,['10.1016/j.sleep.2020.07.020']
2824,32858346,"Effects of treatment of sleep disorders on sleep, psychological and cognitive functioning and biomarkers in individuals with HIV/AIDS and under methadone maintenance therapy.","BACKGROUND


Poor sleep is a major complaint of people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing methadone maintenance therapy (MMT). We tested the impact of three different sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training + trazodone) on sleep, psychological functioning and biomarkers in males with HIV and undergoing MMT.
METHODS


A total of 75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention. Participants were randomly assigned to one of the following conditions: trazodone 50 mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT + TRAZ). At baseline, and six and 12 weeks later, participants completed questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety. In parallel, their cognitive performance (working memory; sustained attention) was assessed. Biomarkers (cortisol, BNDF, CD4 + ) were assessed at baseline and at the end of the study.
RESULTS


Over time, sleep disturbances decreased and daytime functioning and overall sleep quality improved. More specifically, both sleep disturbances and daytime functioning improved in the two SHT conditions from baseline to week 6. Daytime functioning remained stable from week 6 to week 12. Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12. Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing remained unchanged. Sustained attention performance improved over time from baseline to week 6 and remained high through to week 12. Biomarkers remained unchanged.
CONCLUSIONS


In males with HIV and undergoing MMT, treating sleep disturbances over a period of six to 12 weeks had a positive impact on aspects of sleep disturbance, symptoms of depression and anxiety, and cognitive performance. The results indicate that sleep hygiene training, either as stand-alone or in combination with trazodone, can produce positive results.",2020,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","['75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention', 'males with HIV and undergoing', 'males with HIV and undergoing MMT', 'people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing', 'individuals with HIV/AIDS and under methadone maintenance therapy']","['MMT', 'methadone maintenance therapy (MMT', 'sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training\xa0+\xa0trazodone', 'trazodone 50\xa0mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT\xa0+\xa0TRAZ', 'trazodone']","['sleep, psychological and cognitive functioning and biomarkers', 'sleep, psychological functioning and biomarkers', 'Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing', 'questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety', 'depression and anxiety', 'Sustained attention performance', 'sleep disturbances and daytime functioning', 'Daytime functioning', 'sleep disturbances', 'Biomarkers (cortisol, BNDF, CD4 + ', 'daytime functioning and overall sleep quality', 'sleep disturbance, symptoms of depression and anxiety, and cognitive performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",75.0,0.0231424,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Radmehr', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Mohamadi', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Omran', 'Initials': 'O', 'LastName': 'Davarinejad', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Dürsteler', 'Affiliation': 'University of Basel, Psychiatric Clinics, Division of Substance Use Disorders Basel, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: serge.brand@upk.ch.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.043']
2825,32860109,Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial.,"PURPOSE


Evidence supporting the value of preoperative antibiotic prophylaxis (PAP) in surgery for acute cholecystitis is lacking. This study aimed to shed light on whether PAP in acute cholecystectomy for cholecystitis reduces the postoperative infectious complication (PIC) rate. Secondary outcomes were the prevalence of bacteriobilia, CRP values and leucocyte counts.
METHODS


The study was performed as a single-centre, double-blinded, placebo-controlled, randomised study. Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy were randomly assigned to either PAP (piperacillin/ tazobactam) or placebo, and the subsequent clinical course was followed.
RESULTS


A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation. PIC developed in 22 of the 90 patients included with no significant difference between the PAP and placebo groups (8 patients in the PAP group and 14 in the placebo arm, p = 0.193). The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups.
CONCLUSION


PAP does not affect the risk for PIC in patients with acute cholecystitis. The major risk factors determining PIC in these patients need defining, in particular, the impact of bacteriobilia.
TRIAL REGISTRATION


The study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015.",2020,"The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups.
","['Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy', 'A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation', 'patients with acute cholecystitis', 'acute cholecystectomy revisited']","['placebo', 'preoperative antibiotic prophylaxis (PAP', 'PAP (piperacillin/ tazobactam) or placebo', 'Antibiotic prophylaxis']","['risk for PIC', 'PIC', 'postoperative infectious complication (PIC) rate', 'PIC rate', 'prevalence of bacteriobilia, CRP values and leucocyte counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0075870', 'cui_str': 'tazobactam'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",106.0,0.562603,"The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups.
","[{'ForeName': 'Gona', 'Initials': 'G', 'LastName': 'Jaafar', 'Affiliation': 'Subject Trauma Reparative Medicine, CLINTEC, Karolinska University Hospital, 14186, Stockholm, Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sandblom', 'Affiliation': 'Department of Clinical Science and Education, Department of Surgery, Södersjukhuset, Karolinska Institute, Stockholm, Sweden. gabriel.sandblom@ki.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lundell', 'Affiliation': 'Department of Surgery, CLINTEC, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Hammarqvist', 'Affiliation': 'Subject Trauma Reparative Medicine, CLINTEC, Karolinska University Hospital, 14186, Stockholm, Sweden.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01977-x']
2826,32860117,The effect of breaking up prolonged sitting on paired associative stimulation-induced plasticity.,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE). This effect is attenuated in older and less active individuals. Although a single bout of exercise enhances PAS-induced plasticity in young, physically inactive adults, it is not yet known if physical activity interventions affect PAS-induced neuroplasticity in middle-aged inactive individuals. Sixteen inactive middle-aged office workers participated in a randomized cross-over design investigating how CSE and short-interval intracortical inhibition (SICI) were affected by PAS preceded by 3 h of sitting (SIT), 3 h of sitting interrupted every 30 min by 3 min of frequent short bouts of physical activity (FPA) and 2.5 h of sitting followed by 25 min of moderate-intensity exercise (EXE). Transcranial magnetic stimulation was applied over the primary motor cortex (M1) of the dominant abductor pollicis brevis to induce recruitment curves before and 5 min and 30 min post-PAS. Linear mixed models were used to compare changes in CSE using time and condition as fixed effects and subjects as random effects. There was a main effect of time on CSE and planned within-condition comparisons showed that CSE was significantly increased from baseline to 5 min and 30 min post-PAS, in the FPA condition, with no significant changes in the SIT or EXE conditions. SICI decreased from baseline to 5 min post-PAS, but this was not related to changes in CSE. Our findings suggest that in middle-aged inactive adults, FPAs may promote corticospinal neuroplasticity. Possible mechanisms are discussed.",2020,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE).","['older and less active individuals', 'middle-aged inactive individuals', 'Sixteen inactive middle-aged office workers']","['CSE and short-interval intracortical inhibition (SICI) were affected by PAS preceded by 3\xa0h of sitting (SIT), 3\xa0h of sitting interrupted every 30\xa0min by 3\xa0min of frequent short bouts of physical activity (FPA) and 2.5\xa0h of sitting followed by 25\xa0min of moderate-intensity exercise (EXE', 'Paired associative stimulation (PAS', 'Transcranial magnetic stimulation']","['CSE', 'SICI']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.106179,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bojsen-Møller', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden. emil.bojsen.moller@gih.se.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}]",Experimental brain research,['10.1007/s00221-020-05866-z']
2827,32860261,Telephone-based counselling helped parents to wean children off bottles at two years of age.,"Prolonged bottle-feeding has been associated with dental caries, obesity, iron deficiency and inappropriate eating habits. Previous studies on outpatient-based bottle-weaning interventions have showed mixed results (1-3). The aim of this randomised controlled trial was to compare a novel telephone-based intervention on bottle weaning, which extended beyond busy outpatient hours, with standard outpatient-based advice.",2020,"The aim of this randomised controlled trial was to compare a novel telephone-based intervention on bottle weaning, which extended beyond busy outpatient hours, with standard outpatient-based advice.",[],"['Telephone-based counselling helped parents', 'novel telephone-based intervention', 'Prolonged bottle-feeding']",[],[],"[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0006042', 'cui_str': 'Bottle feeding of patient'}]",[],,0.091966,"The aim of this randomised controlled trial was to compare a novel telephone-based intervention on bottle weaning, which extended beyond busy outpatient hours, with standard outpatient-based advice.","[{'ForeName': 'Sasivara', 'Initials': 'S', 'LastName': 'Boonrusmee', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Sireepatch', 'Initials': 'S', 'LastName': 'Cheamsanit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15550']
2828,32860331,Patient-reported tolerability of veliparib combined with cisplatin and etoposide for treatment of extensive stage small cell lung cancer: Neurotoxicity and adherence data from the ECOG ACRIN cancer research group E2511 phase II randomized trial.,"OBJECTIVES


The ECOG-ACRIN Cancer Research Group trial E2511 recently demonstrated a potential benefit for the addition of veliparib to cisplatin-etoposide (CE) in patients with extensive stage small cell lung cancer (ES-SCLC) in a phase II randomized controlled trial. Secondary trial endpoints included comparison of the incidence and severity of neurotoxicity, hypothesized to be lower in the veliparib arm, and tolerability of the addition of veliparib to CE. Physician-rated and patient-reported neurotoxicity was also compared.
MATERIALS AND METHODS


Patients randomized to veliparib plus CE (n = 64) or placebo plus CE (n = 64) completed the 11-item Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (questionnaire pre-treatment, end of cycle 4 [ie 3 months after randomization] and 3 months post-treatment [ie 6-months]). Adherence analysis was based on treatment forms.
RESULTS AND CONCLUSION


No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point. However, patients in the placebo arm reported worsening neurotoxicity from baseline to 3-months (M difference = -1.5, P = .045), compared to stable neurotoxicity in the veliparib arm (M difference = -0.2, P = .778). Weakness was the most common treatment-emergent (>50%) and moderate to severe (>16%) symptom reported, but did not differ between treatment arms. The proportion of adherence to oral therapy in the overall sample was 75%. Three percent of patients reported clinically significant neurotoxicity that was not captured by physician assessment. Neurotoxicity scores were not different between treatment arms. The addition of veliparib to CE appeared tolerable, though weakness should be monitored. CLINICALTRIALS.
GOV IDENTIFIER


NCT01642251.",2020,No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point.,"['patients with extensive stage small cell lung cancer (ES-SCLC', 'n\xa0=\xa064) or', 'extensive stage small cell lung cancer']","['veliparib combined with cisplatin and etoposide', 'veliparib plus CE', 'placebo', 'veliparib to cisplatin-etoposide (CE', 'placebo plus CE', '11-item Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (questionnaire pre-treatment']","['mean or magnitude of change in neurotoxicity scores', 'moderate to severe', 'worsening neurotoxicity', 'incidence and severity of neurotoxicity, hypothesized to be lower in the veliparib arm, and tolerability of the addition of veliparib to CE', 'stable neurotoxicity', 'Neurotoxicity scores', 'Weakness', 'neurotoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0078414', 'cui_str': 'VP-P protocol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0078414', 'cui_str': 'VP-P protocol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]",,0.208248,No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point.,"[{'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'Steffen McLouth', 'Affiliation': 'Department of Behavioral Science, Center for Health Equity Transformation, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Dana-Farber Cancer Institute & ECOG-ACRIN Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Josephine L', 'Initials': 'JL', 'LastName': 'Feliciano', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Mohindra', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Dahlberg', 'Affiliation': 'Dana-Farber Cancer Institute & ECOG-ACRIN Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Heartland NCORP, Decatur, IL, USA.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Srkalovic', 'Affiliation': 'Sparrow Herbert-Herman Cancer Center, Lansing, MI, USA.'}, {'ForeName': 'Bradley W', 'Initials': 'BW', 'LastName': 'Lash', 'Affiliation': 'Guthrie Clinic - Robert Packer Hospital, Sayre, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leach', 'Affiliation': 'Metro Minnesota NCORP, Minneapolis, MN, USA.'}, {'ForeName': 'Ticiana A', 'Initials': 'TA', 'LastName': 'Leal', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Aggarwal', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Cancer medicine,['10.1002/cam4.3416']
2829,32860344,Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program.,"OBJECTIVE


The aim of this study was to investigate the 6-month nonintervention follow-up effects of a cognitive behavioral intervention for weight bias internalization (WBI; i.e., self-stigma) combined with behavioral weight loss (BWL).
METHODS


Adults with obesity and elevated WBI were previously randomized to receive BWL alone or in combination with the Weight Bias Internalization and Stigma program (BWL + BIAS). Participants attended weekly group meetings for 12 weeks, followed by two biweekly and two monthly meetings (26 weeks total). Follow-up assessments were conducted at week 52. Changes on the Weight Bias Internalization Scale and Weight Self-Stigma Questionnaire at week 52 were the principal outcomes. Other outcomes included changes in eating, coping, and weight.
RESULTS


Of 72 randomized participants, 54 (75%) completed week 52 assessments. Linear mixed models showed improvements across groups, but no significant differences between groups, in week 52 change on the Weight Bias Internalization Scale (P = 0.25) or Weight Self-Stigma Questionnaire (P = 0.27). BWL + BIAS participants reported significantly greater benefits than BWL participants on measures of eating and affective coping with weight stigma. Percent weight loss at week 52 did not differ significantly between groups (BWL + BIAS = -3.1% [SE 1.0%], BWL = -4.0% [SE 1.0%], P = 0.53).
CONCLUSIONS


Reductions in WBI did not differ between groups at 6-month follow-up. Further research is needed to determine the potential benefits of a stigma-reduction intervention beyond BWL.",2020,"Linear mixed models showed improvements across groups, but no significant differences between groups, in week 52 change on the Weight Bias Internalization Scale (P = 0.25) or Weight Self-Stigma Questionnaire (P = 0.27).","['Adults with obesity and elevated WBI', 'Of 72 randomized participants, 54 (75']","['behavioral weight loss (BWL', 'BWL alone or in combination with the Weight Bias Internalization and Stigma program (BWL\u2009+\u2009BIAS', 'cognitive behavioral intervention']","['Weight Bias Internalization Scale', 'Percent weight loss', 'Weight Bias Internalization Scale and Weight Self-Stigma Questionnaire', 'changes in eating, coping, and weight', 'Weight Self-Stigma Questionnaire', 'WBI', 'eating and affective coping with weight stigma']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",72.0,0.0480705,"Linear mixed models showed improvements across groups, but no significant differences between groups, in week 52 change on the Weight Bias Internalization Scale (P = 0.25) or Weight Self-Stigma Questionnaire (P = 0.27).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bach', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22931']
2830,32854834,Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial.,"BACKGROUND


Transcatheter mitral valve repair with the MitraClip results in marked clinical improvement in some but not all patients with secondary mitral regurgitation (MR) and heart failure (HF).
OBJECTIVES


This study sought to evaluate the clinical predictors of a major response to treatment in the COAPT trial.
METHODS


Patients with HF and severe MR who were symptomatic on maximally tolerated guideline-directed medical therapy (GDMT) were randomly assigned to MitraClip plus GDMT or GDMT alone. Super-responders were defined as those alive without HF hospitalization and with ≥20-point improvement in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score at 12 months. Responders were defined as those alive without HF hospitalization and with a 5 to <20-point KCCQ-OS improvement at 12 months. Nonresponders were those who either died, were hospitalized for HF, or had <5-point improvement in KCCQ-OS at 12 months.
RESULTS


Among 614 enrolled patients, 41 (6.7%) had missing KCCQ-OS data and could not be classified. At 12 months, there were 79 super-responders (27.2%), 55 responders (19.0%), and 156 nonresponders (53.8%) in the MitraClip arm compared with 29 super-responders (10.2%), 46 responders (16.3%), and 208 nonresponders (73.5%) in the GDMT-alone arm (overall p < 0.0001). Independent baseline predictors of clinical responder status were lower serum creatinine and KCCQ-OS scores and treatment assignment to MitraClip. MR grade and estimated right ventricular systolic pressure at 30 days were improved to a greater degree in super-responders and responders but not in nonresponders.
CONCLUSIONS


Baseline predictors of clinical super-responders in patients with HF and severe secondary MR in the COAPT trial were lower serum creatinine, KCCQ-OS score and MitraClip treatment. Improved MR severity and reduced right ventricular systolic pressure at 30 days are associated with a long-term favorable clinical response after transcatheter mitral valve repair. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).",2020,"MR grade and estimated right ventricular systolic pressure at 30 days were improved to a greater degree in super-responders and responders but not in nonresponders.
","['patients with secondary mitral regurgitation (MR) and heart failure (HF', 'Patients with HF and severe MR who were symptomatic on maximally tolerated guideline-directed medical therapy (GDMT', '614 enrolled patients, 41 (6.7%) had missing KCCQ-OS data and could not be classified', 'Heart', 'Failure Patients With Functional Mitral Regurgitation']","['MitraClip plus GDMT or GDMT alone', 'MitraClip Percutaneous Therapy']","['serum creatinine and KCCQ-OS scores', 'MR grade and estimated right ventricular systolic pressure', 'Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score', 'Improved MR severity and reduced right ventricular systolic pressure', 'serum creatinine, KCCQ-OS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456181', 'cui_str': 'Right ventricular systolic pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",614.0,0.0687682,"MR grade and estimated right ventricular systolic pressure at 30 days were improved to a greater degree in super-responders and responders but not in nonresponders.
","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Grayburn', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas. Electronic address: paul.grayburn@BSWHealth.org.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sannino', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, California; Bakersfield Heart Hospital, Bakersfield, California.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Mishell', 'Affiliation': 'Kaiser Permanente-San Francisco Hospital, San Francisco, California.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Whisenant', 'Affiliation': 'Intermountain Heart Center, Salt Lake City, Utah.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rinaldi', 'Affiliation': 'Sanger Heart & Vascular Institute/Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Rajagopal', 'Affiliation': 'Piedmont Hospital, Atlanta, Georgia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Lak N', 'Initials': 'LN', 'LastName': 'Kotinkaduwa', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: https://twitter.com/GreggWStone.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.07.010']
2831,32854838,Angiotensin Receptor-Neprilysin Inhibition Based on History of Heart Failure and Use of Renin-Angiotensin System Antagonists.,"BACKGROUND


The PIONEER-HF (comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode) trial demonstrated the efficacy and safety of sacubitril/valsartan (S/V) in stabilized patients with acute decompensated heart failure (HF) and reduced ejection fraction.
OBJECTIVES


The study sought to determine whether and how prior HF history and treatment with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) affected the results.
METHODS


The PIONEER-HF trial was a prospective, multicenter, double-blind, randomized clinical trial enrolling 881 patients with an ejection fraction ≤40%. Patients were randomly assigned 1:1 to in-hospital initiation of S/V (n = 440) versus enalapril (n = 441). Pre-specified subgroup analyses were performed based on prior HF history (i.e., de novo HF vs. worsening chronic HF) and treatment with an ACE inhibitor or ARB (i.e., ACE inhibitor or ARB-yes vs. ACE inhibitor or ARB-no) at admission.
RESULTS


At enrollment, 303 (34%) patients presented with de novo HF and 576 (66%) patients with worsening chronic HF. A total of 421 (48%) patients had been treated with an ACE inhibitor or ARB, while 458 (52%) had not been treated with an ACE inhibitor or ARB. N-terminal pro-B-type natriuretic peptide declined significantly in all 4 subgroups (p < 0.001), with greater decreases in the S/V versus the enalapril arm (p < 0.001). There was no interaction between prior HF history (p = 0.350) or ACE inhibitor or ARB treatment (p = 0.880) and the effect of S/V versus enalapril on cardiovascular death or rehospitalization for HF. The incidences of adverse events were comparable between S/V and enalapril across all 4 subgroups.
CONCLUSIONS


Among patients admitted for acute decompensated HF, S/V was safe and well tolerated, led to a significantly greater reduction in N-terminal pro-B-type natriuretic peptide, and improved clinical outcomes compared with enalapril irrespective of previous HF history or ACE inhibitor or ARB treatment. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect of NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,"N-terminal pro-B-type natriuretic peptide declined significantly in all 4 subgroups (p < 0.001), with greater decreases in the S/V versus the enalapril arm (p < 0.001).","['Patients', '881 patients with an ejection fraction\xa0≤40', 'patients stabilized from an acute Heart\xa0Failure episode', 'A total of 421 (48%) patients had been treated with an ACE inhibitor or ARB, while 458 (52%) had not been treated with an', 'stabilized patients with acute decompensated heart failure (HF) and reduced ejection fraction']","['sacubitril/valsartan', 'Enalapril', 'ACE inhibitor or ARB', 'NT-proBNP', 'Sacubitril/Valsartan Versus Enalapril', 'Angiotensin Receptor-Neprilysin Inhibition', 'angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB', 'enalapril']","['cardiovascular death or rehospitalization', 'adverse events', 'N-terminal pro-B-type natriuretic peptide', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",881.0,0.0346851,"N-terminal pro-B-type natriuretic peptide declined significantly in all 4 subgroups (p < 0.001), with greater decreases in the S/V versus the enalapril arm (p < 0.001).","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California; Division of Research, Kaiser Permanente Northern California, Oakland, California. Electronic address: andrew.p.ambrosy@kp.org.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Department of Medicine, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Department of Medicine, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCague', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rocha', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.06.073']
2832,32854929,Inferior nasal turbinate mucosa shrinkage prior to surgery under local anaesthesia.,"INTRODUCTION AND OBJECTIVES


Chronic rhinitis-related complaints may result from isolated hypertrophy of the inferior nasal turbinates. If the symptoms persist despite conservative management, turbinoplasty is indicated. However, the nasal mucosa lining the inferior turbinates seems decongested immediately before the surgery performed under local anaesthesia, compared to the examination when the patients were entered for surgery. The study aimed to confirm this observation and to hypothesize as to the reasons for its occurrence.
PATIENTS AND METHODS


The measurements of the longest distances between the medial rim of the inferior nasal turbinate mucosa and nasal septum and the shortest distances between the lower rim of the turbinate and floor of the nasal cavity in the inferior part of both common nasal meatus, were carried out on photos taken during endoscopic examinations: the one entering the patient for turbinoplasty, and the other immediately before the procedure. The results in this group were compared to those obtained from patients operated on under general anaesthesia.
RESULTS


In 130 patients aged 18-60 (mean=40.7) years, operated on under local anaesthesia, the sum of the mean distances between the nasal septum and the medial rim of the lower turbinate in both nasal cavities, was 3.4mm during the first examination, and 4.5mm (p=.0008) during the second one. In the group of 42 participants aged 26-47, mean=36.8 years operated on under general anaesthesia, the values were: 4.8mm and 3.6mm (p=.02), respectively. The differences were significantly smaller in the smokers (.3) compared to non-smokers (1.3; p=.04) mm.
CONCLUSIONS


Records of the entering examination must be considered before turbinoplasty under local anaesthesia.",2020,"The differences were significantly smaller in the smokers (.3) compared to non-smokers (1.3; p=.04) mm.
","['Inferior nasal turbinate mucosa shrinkage prior to surgery under local anaesthesia', '130 patients aged 18-60 (mean=40.7) years, operated on under local anaesthesia, the sum of the mean distances between the nasal septum and the medial rim of the lower turbinate in both nasal cavities, was 3.4mm during the first examination, and 4.5mm (p=.0008) during the second one', '42 participants aged 26-47, mean=36.8 years operated on under general anaesthesia, the values were: 4.8mm and 3.6mm (p=.02), respectively']",[],[],"[{'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0027432', 'cui_str': 'Nasal septum structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1266928', 'cui_str': 'Nasal turbinate bone structure'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C4517694', 'cui_str': '3.6'}]",[],[],130.0,0.0261318,"The differences were significantly smaller in the smokers (.3) compared to non-smokers (1.3; p=.04) mm.
","[{'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Zagólski', 'Affiliation': ""Department of Otorhinolaryngology, St. John Grande's Hospital, Kraków, Poland. Electronic address: olafzag@gmail.com.""}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Stręk', 'Affiliation': 'Department of Otorhinolaryngology, Collegium Medicum, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Lisiecka', 'Affiliation': ""Intensive Care Unit, St. John Grande's Hospital, Kraków, Poland.""}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Gorzedowski', 'Affiliation': 'General Medical Practice, Kaiserslautern, Germany.'}]",Acta otorrinolaringologica espanola,['10.1016/j.otorri.2020.04.004']
2833,32854965,Can an Emergency Department-Initiated Intervention Prevent Subsequent Falls and Health Care Use in Older Adults? A Randomized Controlled Trial.,"STUDY OBJECTIVE


We determine whether an emergency department (ED)-initiated fall-prevention intervention can reduce subsequent fall-related and all-cause ED visits and hospitalizations in older adults.
METHODS


The Geriatric Acute and Post-acute Fall Prevention intervention was a randomized controlled trial conducted from January 2018 to October 2019. Participants at 2 urban academic EDs were randomly assigned (1:1) to an intervention or usual care arm. Intervention participants received a brief, tailored, structured, pharmacy and physical therapy consultation in the ED, with automated communication of the recommendations to their primary care physicians.
RESULTS


Of 284 study-eligible participants, 110 noninstitutionalized older adults (≥65 years) with a recent fall consented to participate; median age was 81 years, 67% were women, 94% were white, and 16.3% had cognitive impairment. Compared with usual care participants (n=55), intervention participants (n=55) were half as likely to experience a subsequent ED visit (adjusted incidence rate ratio 0.47 [95% CI 0.29 to 0.74]) and one third as likely to have fall-related ED visits (adjusted incidence rate ratio 0.34 [95% CI 0.15 to 0.76]) within 6 months. Intervention participants experienced half the rate of all hospitalizations (adjusted incidence rate ratio 0.57 [95% CI 0.31 to 1.04]), but confidence intervals were wide. There was no difference in fall-related hospitalizations between groups (adjusted incidence rate ratio 0.99 [95% CI 0.31 to 3.27]). Self-reported adherence to pharmacy and physical therapy recommendations was moderate; 73% of pharmacy recommendations were adhered to and 68% of physical therapy recommendations were followed.
CONCLUSION


Geriatric Acute and Post-acute Fall Prevention, a postfall, in-ED, multidisciplinary intervention with pharmacists and physical therapists, reduced 6-month ED encounters in 2 urban EDs. The intervention could provide a model of care to other health care systems aiming to reduce costly and burdensome fall-related events in older adults.",2020,There was no difference in fall-related hospitalizations between groups (adjusted incidence rate ratio 0.99,"['older adults', 'Older Adults', 'January 2018 to October 2019', 'Of 284 study-eligible participants', 'Participants at 2 urban academic EDs', ' median age was 81 years, 67% were women, 94% were white, and 16.3% had cognitive impairment', '110 noninstitutionalized older adults (≥65 years) with a recent fall consented to participate']","['emergency department (ED)-initiated fall-prevention intervention', 'brief, tailored, structured, pharmacy and physical therapy consultation in the ED, with automated communication of the recommendations to their primary care physicians']","['rate of all hospitalizations', 'fall-related hospitalizations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",55.0,0.0826064,There was no difference in fall-related hospitalizations between groups (adjusted incidence rate ratio 0.99,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Goldberg', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI; Department of Emergency Medicine, The Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: elizabeth_goldberg@brown.edu.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Marks', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Harvard University, Boston, MA.""}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Resnik', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI; Providence VA Medical Center, Providence, RI.'}, {'ForeName': 'Sokunvichet', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Mellott', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Harvard University, Boston, MA.""}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.07.025']
2834,32854975,"Corrigendum to ""Metabolic linkages between indoor negative air ions, particulate matter and cardiorespiratory function: A randomized, double-blind crossover study among children"" [Environ. Int. 138 (2020) 105663].",,2020,,"['children"" [Environ']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],,0.203812,,"[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Mengtian', 'Initials': 'M', 'LastName': 'Chu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Heqing', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Furong', 'Initials': 'F', 'LastName': 'Deng', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}]",Environment international,['10.1016/j.envint.2020.106073']
2835,32854978,Endoscopic identification of urinary stone composition: A study of South Eastern Group for Urolithiasis Research (SEGUR 2).,"INTRODUCTION AND OBJECTIVES


To assess the surgeon's ability to evaluate the composition of the stone by observation of endoscopic images.
MATERIALS AND METHODS


A series of 20 video clips of endoscopic treatments of urinary stones of which was also available the result of infrared spectroscopy was uploaded to a YouTube site accessible only to members of the South Eastern Group for Urolithiasis Research (SEGUR) who were asked to identify the composition of the stones.
RESULTS


A total of 32 clinicians from 9 different countries participated in the study. The average number of correct detections of participants was 7.81 ± 2.68 (range 1-12). Overall accuracy was 39% (250 out of 640 predictions). Calcium oxalate dihydrate stones have been correctly detected in 69.8%, calcium oxalate monohydrate in 41.8%, uric acid in 33.3%, calcium oxalate/uric acid in 34.3% and cystine in 78.1%. Precision rates for struvite (15.6%), calcium phosphate (0%) and mixed calcium oxalate/calcium phosphate (9.3%) were quite low.
CONCLUSIONS


Observation of the stone during the endoscopic procedure was not reliable to identify the composition of most stones although it gave some information allowing to identify with a good sensitivity calcium oxalate dihydrate and cystine stones. Nevertheless, photo or video reporting of the intact stone and its internal structure could should be encouraged to implement results of still mandatory post-operative stone analysis. Endourologists should improve their ability of visual identification of the different types of stones.",2020,Overall accuracy was 39% (250 out of 640 predictions).,"['A total of 32 clinicians from 9 different countries participated in the study', 'South Eastern Group for Urolithiasis Research (SEGUR 2']",[],"['Calcium oxalate dihydrate stones', 'calcium phosphate', 'Precision rates', 'Overall accuracy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",[],"[{'cui': 'C0006707', 'cui_str': 'Calcium oxalate dihydrate'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",32.0,0.0369808,Overall accuracy was 39% (250 out of 640 predictions).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sampogna', 'Affiliation': ""Departamento de Urología, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milano, Italia.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Basic', 'Affiliation': 'Clínica Urológica, Clinical Center Nis, Nis, Serbia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Geavlete', 'Affiliation': 'Saint John Emergency Clinical Hospital, Bucarest, Rumanía.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Galán Llopis', 'Affiliation': 'Unidad de Litiasis y Endourología, Hospital General Universitario, Alicante, España.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reis Santos', 'Affiliation': 'Uroclínica-Centro Clínico de Urología, Lisboa, Portugal.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Saltirov', 'Affiliation': 'Departamento de Urología y Nefrología, Academia Médica Militar, Sofía, Bulgaria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sarica', 'Affiliation': 'Departamento de Urología, Universidad de Biruni, Facultad de Medicina, Estambul, Turquía.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stavridis', 'Affiliation': 'Clínica Universitaria de Urología, Facultad de Medicina Skopje, Skopje, Macedonia del Norte.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Skolarikos', 'Affiliation': 'Segundo Departamento de Urología, Universidad de Atenas, Hospital Sismanogleio , Atenas, Grecia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Trinchieri', 'Affiliation': 'Escuela de Urología, Universidad de Milán, Milán, Italia. Electronic address: alberto.trinchieri@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Actas urologicas espanolas,['10.1016/j.acuro.2020.01.015']
2836,32855218,Automated closed-loop  versus  standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study.,"INTRODUCTION


Hypoxaemia and hyperoxaemia may occur after surgery, with related complications. This multicentre and randomised trial evaluated the impact of automated closed-loop oxygen administration after high-risk abdominal or thoracic surgeries in terms of optimising the SpO 2  time within target range.
METHODS


After extubation, patients with an intermediate to high risk for postoperative pulmonary complications were randomised to  Standard  or  Automated  closed-loop oxygen administration. The primary outcome was the percentage of time within the oxygenation range, during a 3-day frame. The secondary outcomes were the time with hypoxaemia and hyperoxaemia under oxygen.
RESULTS


Among the 200 patients, time within range was higher in the  Automated  group, both initially (≤3-h; 91.4±13.7  versus  40.2±35.1% of time; difference +51.0% [CI95% -42.8;59.2]; p<0.0001) and during the 3-day period (94.0±11.3  versus  62.1±23.3% of time; difference +31.9% [CI95% 26.3;37.4]; p<0.0001). Periods of hypoxaemia were reduced in the  Automated  group (≤3 days; 32.6±57.8 [1.2±1.9%]  versus  370.5±594.3 min [5.0±11.2%]; difference -10.2% [CI95% -13.9;-6.6]; p<0.0001), as well as hyperoxaemia under oxygen (≤3 days; 5.1±10.9 [4.8±11.2%]  versus  177.9±277.2 min [27.0±23.8%]; difference -22.0% [CI95% -27.6;-16.4]; p<0.0001). Kaplan-Meier analysis depicted a significant difference in terms of hypoxaemia (p=0.01) and severe hypoxaemia (p=0.0003) occurrence between groups in favour of the  Automated  group. Twenty-five patients experienced hypoxaemia for more than 10% of the entire monitoring time during the 3 days within the  Standard  group, as compared to the  Automated  group (p<0.0001).
CONCLUSION


Automated  closed-loop oxygen administration promotes greater time within the oxygenation target, as compared to  Standard  manual administration, thus reducing the occurrence of hypoxaemia and hyperoxaemia.",2020,Kaplan-Meier analysis depicted a significant difference in terms of hypoxaemia (p=0.01) and severe hypoxaemia (p=0.0003) occurrence between groups in favour of the  Automated  group.,['patients with an intermediate to high risk for postoperative pulmonary complications'],"['Automated closed-loop  versus  standard manual oxygen administration after major abdominal or thoracic surgery', 'automated closed-loop oxygen administration', 'Standard  or  Automated  closed-loop oxygen administration']","['Periods of hypoxaemia', 'severe hypoxaemia', 'hypoxaemia', 'hyperoxaemia under oxygen', 'time within range', 'time with hypoxaemia and hyperoxaemia under oxygen', 'percentage of time within the oxygenation range, during a 3-day frame']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]",200.0,0.264607,Kaplan-Meier analysis depicted a significant difference in terms of hypoxaemia (p=0.01) and severe hypoxaemia (p=0.0003) occurrence between groups in favour of the  Automated  group.,"[{'ForeName': 'Erwan', 'Initials': 'E', 'LastName': ""L'Her"", 'Affiliation': 'Medical Intensive Care, CHRU de Brest - La Cavale Blanche, Brest Cedex, France Erwan.lher@chu-brest.fr.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Intensive Care Unit, Department of Anaesthesiology B, DAR B CHU de Montpellier, Hôpital Saint Eloi, Université Montpellier 1, Montpellier, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Verzilli', 'Affiliation': 'Intensive Care Unit, Department of Anaesthesiology B, DAR B CHU de Montpellier, Hôpital Saint Eloi, Université Montpellier 1, Montpellier, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Anaesthesiology Department, CHRU de Brest - La Cavale Blanche, Bvd Tanguy-Prigent, Brest Cedex, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Huiban', 'Affiliation': 'Anaesthesiology Department, CHRU de Brest - La Cavale Blanche, Bvd Tanguy-Prigent, Brest Cedex, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': 'Anaesthesiology Department, Hôpital Estaing, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kerforne', 'Affiliation': 'Anaesthesiology Department, CHU de Poitiers, Cedex, France.'}, {'ForeName': 'Victoire', 'Initials': 'V', 'LastName': 'Pateau', 'Affiliation': 'LATIM INSERM UMR 1101, FHU Techsan, Université de Bretagne Occidentale, Brest, France.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bouchard', 'Affiliation': ""Centre de recherche de l'Institut de Cardiologie et de Pneumologie de Québec, Québec, Canada.""}, {'ForeName': 'Maëlys', 'Initials': 'M', 'LastName': 'Consigny', 'Affiliation': ""Centre d'Investigation Clinique CIC INSERM 1412, CHRU Brest - La Cavale Blanche, Brest Cedex, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lellouche', 'Affiliation': ""Centre de recherche de l'Institut de Cardiologie et de Pneumologie de Québec, Québec, Canada.""}]",The European respiratory journal,['10.1183/13993003.00182-2020']
2837,32855225,Efficacy and safety of TOBI Podhaler® in  Pseudomonas aeruginosa -infected bronchiectasis patients: iBEST study.,"INTRODUCTION


The study aimed to determine the efficacy of a safe and well-tolerated dose and regimen of tobramycin inhalation powder (TIP) on  Pseudomonas aeruginosa  ( Pa ) sputum density in patients with bronchiectasis (BE).
METHODS


This is a phase II, double-blind, randomised study in BE patients aged ≥18 years with chronic  Pa  infection. Patients were randomised 1:1:1 to either Cohort A: 3 capsules of TIP O.D. (84 mg); Cohort B: 5 capsules O.D. (140 mg) or Cohort C: 4 capsules B.I.D. (224 mg). Within each cohort, patients were further randomised 2:2:1 either to TIP continuously, TIP cyclically (alternating 28 days of TIP and placebo) or placebo for 16 weeks, respectively, and were followed up for 8 weeks.
RESULTS


Overall, 107 patients were randomised to Cohorts A (n=34), B (n=36) and C (n=37). All three TIP doses significantly reduced the  Pa  sputum density from baseline to Day 29  versus  placebo in a dose-dependent manner (p≤0.0001, each). A smaller proportion of patients in the continuous-TIP (34.1%) and cyclical-TIP (35.7%) groups experienced pulmonary exacerbations  versus  placebo (47.6%) and also required fewer anti-pseudomonal antibiotics (38.6% on continuous-TIP and 42.9% on cyclical-TIP)  versus  placebo (57.1%) although not statistically significant. Pulmonary exacerbation of BE was the most frequent (37.4%) adverse event (AE). Overall, TIP was well tolerated, however, 23.4% of the patients discontinued the study drug due to AEs.
CONCLUSION


Continuous- and cyclical-TIP regimens with all three doses were safe and effective in reducing the  Pa  sputum density in patients with BE and chronic  Pa  infection.",2020,"All three TIP doses significantly reduced the  Pa  sputum density from baseline to Day 29  versus  placebo in a dose-dependent manner (p≤0.0001, each).","['107 patients were randomised to Cohorts A (n=34), B (n=36) and C (n=37', 'patients with bronchiectasis (BE', 'Pseudomonas aeruginosa -infected bronchiectasis patients', 'BE patients aged ≥18\u2005years with chronic  Pa  infection', 'patients with BE and chronic  Pa  infection']","['TIP continuously, TIP cyclically (alternating 28\u2005days of TIP and placebo) or placebo', 'TIP O.D', 'placebo', 'tobramycin inhalation powder (TIP', 'TOBI Podhaler®']","['pulmonary exacerbations', 'Pulmonary exacerbation of BE', 'anti-pseudomonal antibiotics', 'Pa  sputum density', 'cyclical-TIP']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C3556836', 'cui_str': 'Tobramycin Inhalation Powder'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0723764', 'cui_str': 'Tobi'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C3556836', 'cui_str': 'Tobramycin Inhalation Powder'}]",107.0,0.217363,"All three TIP doses significantly reduced the  Pa  sputum density from baseline to Day 29  versus  placebo in a dose-dependent manner (p≤0.0001, each).","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Loebinger', 'Affiliation': 'Host Defence Unit, Royal Brompton Hospital and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Polverino', 'Affiliation': ""Respiratory Disease Department, Vall d' Hebron University Hospital - VHIR, Barcelona, Spain.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, Scotland, UK.'}, {'ForeName': 'Harm A W M', 'Initials': 'HAWM', 'LastName': 'Tiddens', 'Affiliation': ""Department of Paediatric Pulmonology and Allergology, Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Department of Clinical Microbiology, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tunney', 'Affiliation': ""Halo Research Group, School of Pharmacy, Queen's University Belfast, Belfast, UK M.Loebinger@rbht.nhs.uk.""}, {'ForeName': 'Felix C', 'Initials': 'FC', 'LastName': 'Ringhausen', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, and Biomedical Research in End-stage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Department of Respiratory Medicine, Royal Infirmary of Edinburgh, and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rashidkhan', 'Initials': 'R', 'LastName': 'Pathan', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Angyalosi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': 'Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Elborn', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Haworth', 'Affiliation': 'Cambridge Centre for Lung Infection, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01451-2020']
2838,32855275,Clinical significance of chromatin-spliceosome acute myeloid leukemia: a report from the Northern Italy Leukemia Group (NILG) randomized trial 02/06.,"Secondary acute myeloid leukemia (sAML) after myelodysplastic or myeloproliferative disorders is a high-risk category currently identified by clinical history or specific morphological and cytogenetic abnormalities. However, in the absence of these features, uncertainties remain to identify the secondary nature of some cases otherwise defined as de novo AML. To test whether a chromatin-spliceosome (CS) mutational signature might better inform the definition of the de novo AML group, we analyzed a prospective cohort of 413 newly diagnosed AML patients enrolled into a randomized clinical trial (NILG AML 02/06) and provided with accurate cytogenetic and molecular characterization. Among clinically defined de novo AML, 17.6% carried CS mutations (CS-AML) and showed clinical characteristics closer to sAML (older age, lower white blood cell counts and higher rate of multilineage dysplasia). Outcomes in this group were adverse, more similar to those of sAML as compared to de novo AML (overall survival, 30% in CS-AML and 17% in sAML vs 61% in de novo AML, P<0.0001; disease free survival, 26% in CS-AML and 22% in sAML vs 54% of de novo AML, P<0.001) and independently confirmed by multivariable analysis. Allogeneic transplant in first complete remission improved survival in both sAML and CS-AML patients. In conclusion, these findings highlight the clinical significance of identifying CS-AML for improved prognostic prediction and potential therapeutic implications. (NILG AML 02/06: ClinicalTrials.gov Identifier: NCT00495287).",2020,"Outcomes in this group were adverse, more similar to those of sAML as compared to de novo AML (overall survival, 30% in CS-AML and 17% in sAML vs 61% in de novo AML, P<0.0001; disease free survival, 26% in CS-AML and 22% in sAML vs 54% of de novo AML, P<0.001) and independently confirmed by multivariable analysis.","['chromatin-spliceosome acute myeloid leukemia', 'Secondary acute myeloid leukemia (sAML) after myelodysplastic or myeloproliferative disorders', '413 newly diagnosed AML patients']",['chromatin-spliceosome (CS) mutational signature'],"['disease free survival', 'survival', 'novo AML (overall survival']","[{'cui': 'C0008546', 'cui_str': 'Chromatin'}, {'cui': 'C0162771', 'cui_str': 'Spliceosomes'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027022', 'cui_str': 'Myeloproliferative disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008546', 'cui_str': 'Chromatin'}, {'cui': 'C0162771', 'cui_str': 'Spliceosomes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",413.0,0.104691,"Outcomes in this group were adverse, more similar to those of sAML as compared to de novo AML (overall survival, 30% in CS-AML and 17% in sAML vs 61% in de novo AML, P<0.0001; disease free survival, 26% in CS-AML and 22% in sAML vs 54% of de novo AML, P<0.001) and independently confirmed by multivariable analysis.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caprioli', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lussana', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Salmoiraghi', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII and FROM Research Foundation, Bergamo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cavagna', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Buklijas', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Elidi', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': ""Zanghi'"", 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Michelato', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Delaini', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Oldani', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Intermesoli', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Grassi', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Gianfaldoni', 'Affiliation': 'AOU Careggi, Firenze, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mannelli', 'Affiliation': 'AOU Careggi, Firenze, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Ferrero', 'Affiliation': 'AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Ernesta', 'Initials': 'E', 'LastName': 'Audisio', 'Affiliation': 'AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Terruzzi', 'Affiliation': 'Azienda Ospedaliera San Gerardo, Monza, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'De Paoli', 'Affiliation': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cattaneo', 'Affiliation': 'Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borlenghi', 'Affiliation': 'Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cavattoni', 'Affiliation': 'Ospedale San Maurizio, Bolzano, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tajana', 'Affiliation': 'ASST Ospedale di Cremona, Cremona, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Scattolin', 'Affiliation': ""Ospedale dell'Angelo e SS. Giovanni e Paolo, Venezia Mestre, Italy.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Mattei', 'Affiliation': 'Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Campiotti', 'Affiliation': ""Università dell'Insubria, Varese, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ciceri', 'Affiliation': 'IRCCS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bernardi', 'Affiliation': 'IRCCS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Todisco', 'Affiliation': 'IRCCS Istituto Clinico Humanitas di Rozzano, Rozzano, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Cortelezzi', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Brunangelo', 'Initials': 'B', 'LastName': 'Falini', 'Affiliation': 'Università di Perugia, Perugia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pavoni', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Bassan', 'Affiliation': ""Ospedale dell'Angelo e SS. Giovanni e Paolo, Venezia Mestre, Italy.""}, {'ForeName': 'Orietta', 'Initials': 'O', 'LastName': 'Spinelli', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy; arambaldi@asst-pg23.it.'}]",Haematologica,['10.3324/haematol.2020.252825']
2839,32855372,Buccal infiltration injection without a 4% articaine palatal injection for maxillary impacted third molar surgery.,"Objectives


Palatal infiltration is the most painful and uncomfortable anesthesia technique for maxillary impacted third molar surgery (MITMS). This approach could cause patients distress and aversion to dental treatment. The aim of this study was to evaluate the anesthetic efficacy of a buccal infiltration injection without a palatal injection in MITMS.
Materials and Methods


This prospective research study was a crossover split mouth-randomized controlled trial. Twenty-eight healthy symmetrical bilateral MITMS patients (mean age, 23 years) were randomly assigned to two groups. Buccal infiltration injections without palatal injections were designated as the study group and the buccal with palatal infiltration cases were the control group, using 4% articaine and 1:100,000 epinephrine. The operation started after 10 minutes of infiltration. Pain assessment was done using a visual analogue scale and a numeric rating scale after each injection and extraction procedure. Similarly, the success rate, hemodynamic parameters, and additional requested local anesthetic were assessed.
Results


The results showed that the pain associated with local anesthetic injections between both groups were significantly different. However, the success rates between the groups were not significantly different. Postoperative pain was not significant between both groups and a few patients requested an additional local anesthetic, but the results were not statistically significant. For hemodynamic parameters, there was a significant difference in systolic pressure during incision, bone removal, and tooth elevation. In comparison, during the incision stage there was a significant difference in diastolic pressure; however, other steps in the intervention were not significantly different between groups.
Conclusion


We concluded that buccal infiltration injection without palatal injection can be an alternative technique instead of the conventional injection for MITMS.",2020,"Postoperative pain was not significant between both groups and a few patients requested an additional local anesthetic, but the results were not statistically significant.","['Twenty-eight healthy symmetrical bilateral MITMS patients (mean age, 23 years', 'maxillary impacted third molar surgery']","['articaine palatal injection', 'buccal infiltration injection', 'articaine and 1:100,000 epinephrine']","['diastolic pressure', 'success rate, hemodynamic parameters, and additional requested local anesthetic', 'Pain assessment', 'visual analogue scale and a numeric rating scale', 'success rates', 'Postoperative pain', 'anesthetic efficacy', 'pain associated with local anesthetic injections', 'systolic pressure during incision, bone removal, and tooth elevation']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",28.0,0.061629,"Postoperative pain was not significant between both groups and a few patients requested an additional local anesthetic, but the results were not statistically significant.","[{'ForeName': 'Som', 'Initials': 'S', 'LastName': 'Sochenda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chakorn', 'Initials': 'C', 'LastName': 'Vorakulpipat', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kumar K', 'Initials': 'KK', 'LastName': 'C', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chavengkiat', 'Initials': 'C', 'LastName': 'Saengsirinavin', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manus', 'Initials': 'M', 'LastName': 'Rojvanakarn', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthamet', 'Initials': 'N', 'LastName': 'Wongsirichat', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}]",Journal of the Korean Association of Oral and Maxillofacial Surgeons,['10.5125/jkaoms.2020.46.4.250']
2840,32855884,"Quality Control Procedures and Baseline Values for Electroretinography, Perimetry, Color Vision, and Visual Acuity in an International Multicenter Study: Observations from a Safety Trial in Chronic Stable Angina Pectoris.","Purpose


To describe quality control procedures and baseline values of electroretinography (ERG), kinetic and static perimetry, color discrimination, and best-corrected visual acuity from a multicenter ocular safety study.
Methods


A multicenter prospective longitudinal randomized placebo-controlled study was conducted at 11 ophthalmic centers that had received certification following training, instruction, and monitoring. ERGs were obtained with the Espion E2 Ganzfeld console, perimetry with the Octopus 101 perimeter, color discrimination with the Lanthony desaturated D15 test, and best-corrected visual acuity with the Early Treatment Diabetic Retinopathy Study chart. Ophthalmic eligibility required satisfactory outcomes for ERG and perimetry by the second or third pre-inclusion attempts, respectively. Quality control for the ERG was undertaken by two central readers.
Results


The mean (SD) age of the 97 individuals was 63.5 (7.9) range, 44-83 years. The overall coefficients of variation (CVs) for the ERG peak times were less than those of the only comparable single-center study. The CV for the mean defect of standard automated perimetry was approximately one-third that of the Ocular Hypertension Treatment Study. With increasing age, ERG peak times and color discrimination Total Error Score increased while ERG amplitudes and isopter area all decreased.
Conclusions


The data illustrate the benefit of identical equipment, stringent on-site instruction and training, quality control, certification, and validation methods. The latter are recommended for planning and conducting multicenter trials using ERG and perimetry to monitor safety and/or efficacy of treatment intervention.
Translational Relevance


Stringent quality control procedures and reliable reference values are indispensable prerequisites for informative clinical trials.",2020,"With increasing age, ERG peak times and color discrimination Total Error Score increased while ERG amplitudes and isopter area all decreased.
","['Chronic Stable Angina Pectoris', 'The mean (SD) age of the 97 individuals was 63.5 (7.9) range, 44-83 years', '11 ophthalmic centers that had received certification following training, instruction, and monitoring']",['placebo'],"['Quality Control Procedures and Baseline Values for Electroretinography, Perimetry, Color Vision, and Visual Acuity', 'overall coefficients of variation (CVs) for the ERG peak times', 'electroretinography (ERG), kinetic and static perimetry, color discrimination, and best-corrected visual acuity']","[{'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0031061', 'cui_str': 'Perimetry'}, {'cui': 'C0086032', 'cui_str': 'Color vision'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",,0.0716218,"With increasing age, ERG peak times and color discrimination Total Error Score increased while ERG amplitudes and isopter area all decreased.
","[{'ForeName': 'Eberhart', 'Initials': 'E', 'LastName': 'Zrenner', 'Affiliation': 'Center for Ophthalmology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Holder', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schiefer', 'Affiliation': 'Center for Ophthalmology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Wild', 'Affiliation': 'College of Biomedical Sciences, Cardiff University, Cardiff, UK.'}]",Translational vision science & technology,['10.1167/tvst.9.8.38']
2841,32855889,Ranibizumab Population Pharmacokinetics and Free VEGF Pharmacodynamics in Preterm Infants With Retinopathy of Prematurity in the RAINBOW Trial.,"Purpose


To develop a population pharmacokinetic (PK) model for intravitreal ranibizumab in infants with retinopathy of prematurity (ROP) and assess plasma free vascular endothelial growth factor (VEGF) pharmacodynamics (PD).
Methods


The RAnibizumab compared with laser therapy for the treatment of INfants BOrn prematurely With retinopathy of prematurity (RAINBOW) trial enrolled 225 infants to receive a bilateral intravitreal injection of ranibizumab 0.1 mg, ranibizumab 0.2 mg, or laser in a 1:1:1 ratio and included sparse sampling of blood for population PK and PD analysis. An adult PK model using infant body weight as a fixed allometric covariate was re-estimated using the ranibizumab concentrations in the preterm population. Different variability, assumptions, and covariate relationships were explored. Model-based individual predicted concentrations of ranibizumab were plotted against observed free VEGF concentrations.
Results


Elimination of ranibizumab had a median half-life of 5.6 days from the eye and 0.3 days from serum, resulting in an apparent serum half-life of 5.6 days. Time to reach maximum concentration was rapid (median: 1.3 days). Maximum concentration (median 24.3 ng/mL with ranibizumab 0.2 mg) was higher than that reported in adults. No differences in plasma free VEGF concentrations were apparent between the groups or over time. Plotted individual predicted concentrations of ranibizumab against observed free VEGF concentrations showed no relationship.
Conclusions


In preterm infants with ROP, elimination of ranibizumab from the eye was the rate-limiting step and was faster compared with adults. No reduction in plasma free VEGF was observed. The five-year clinical safety follow-up from RAINBOW is ongoing.
Translational Relevance


Our population PK and VEGF PD findings suggest a favorable ocular efficacy: systemic safety profile for ranibizumab in preterm infants.",2020,Maximum concentration (median 24.3 ng/mL with ranibizumab 0.2 mg) was higher than that reported in adults.,"['INfants BOrn prematurely With retinopathy of prematurity (RAINBOW) trial enrolled 225 infants', 'preterm infants', 'infants with retinopathy of prematurity (ROP', 'Preterm Infants With Retinopathy of Prematurity']","['laser therapy', 'RAnibizumab', 'intravitreal ranibizumab', 'bilateral intravitreal injection of ranibizumab 0.1 mg, ranibizumab 0.2 mg, or laser in a 1:1:1 ratio and included sparse sampling of blood for population PK and PD analysis', 'Ranibizumab Population Pharmacokinetics and Free VEGF Pharmacodynamics', 'ranibizumab']","['plasma free vascular endothelial growth factor (VEGF) pharmacodynamics (PD', 'Maximum concentration', 'ocular efficacy: systemic safety profile', 'median half-life', 'plasma free VEGF concentrations', 'plasma free VEGF']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",225.0,0.264295,Maximum concentration (median 24.3 ng/mL with ranibizumab 0.2 mg) was higher than that reported in adults.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fidler', 'Affiliation': 'Pharmacometrics Ophthalmology, Novartis Pharmaceuticals Corporation, Fort Worth, TX, USA.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Fleck', 'Affiliation': 'Department of Ophthalmology, Princess Alexandra Eye Pavilion, Edinburgh, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stahl', 'Affiliation': 'Department of Ophthalmology, University Medical Center, Greifswald, Germany.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""Academic Neonatology, UCL Elizabeth Garrett Anderson Institute for Women's Health, London, UK.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Chastain', 'Affiliation': 'Novartis Institutes for BioMedical Research, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Lepore', 'Affiliation': 'Department of Ophthalmology, Gemelli Foundation IRCSS, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Reynolds', 'Affiliation': 'Ross Eye Institute, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Chiang', 'Affiliation': 'Casey Eye Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Alistair R', 'Initials': 'AR', 'LastName': 'Fielder', 'Affiliation': 'Department of Optometry and Visual Science, City, University of London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Translational vision science & technology,['10.1167/tvst.9.8.43']
2842,32855910,Evaluation of Presurgical Serum Cortisol Level in Patients Undergoing Major Maxillofacial Surgery.,"Background


Stress is an integral part of life. Anxiety levels may increase when it comes to being treated surgically due to road traffic accidents causing facial trauma, other pathologies or burns. The stress that is caused during a surgical procedure as well as during the treatment in debilitated patients or traumatic conditions is bound to cause disturbance in the metabolic and physiologic levels of cortisol. Therefore, a study was carried out to determine the cortisol levels just prior to surgery on the day of operation to quantify the stress levels and also aid in any preanesthetic medication changes for the patient undergoing maxillofacial surgery.
Aim


To evaluate and compare pre-surgical serum cortisol levels in patients undergoing major maxillofacial surgery under general anaesthesia.
Objective


To evaluate the serum cortisol level of patient 3 days prior to surgery, on the day of surgery and to compare and evaluate the difference seen in both the obtained values.
Methods


A prospective, randomized, in- vivo study was carried out in the Department of Oral and Maxillofacial Surgery at a teaching dental hospital. A total of 32 patients were included in this study. Inclusion and Exculsion criteria was made along with pre-opertive assessment of the patient, informed consent was obtained from all patients involved in the study. Patient blood sample, at 8 am three days prior to surgery and on the day of surgery and sent for laboratory investigations.
Result


Participants in this clinical study underwent treatment of various ailments like facial trauma, and miscellaneous pathologies like Dentigerous Cyst, Oral submucosa fibrosis, Osteomyelitis, Benign Tumor and Orthognathic surgery. The anxiety of the patients were assessed by serum cortisol level preoperatively and on the day of operation. A total of 32 patients, 26 male and 06 female were included in the study. There was statistically highly significant difference seen between the mean values obtained three days prior to surgery and on the day of surgery.
Conclusion


We have concluded from this study that the serum cortisol level shows significant increase on the day of surgery. A future study can focus on association between increased levels of serum cortisol and postoperative wound healing where patients can be divided into two groups one receiving pre-operative stress reduction protocol and other not receiving the same.",2020,"There was statistically highly significant difference seen between the mean values obtained three days prior to surgery and on the day of surgery.
","['Department of Oral and Maxillofacial Surgery at a teaching dental hospital', 'Patients Undergoing Major Maxillofacial Surgery', 'Result\n\n\nParticipants in this clinical study underwent treatment of various ailments like facial trauma, and miscellaneous pathologies like Dentigerous Cyst, Oral submucosa fibrosis, Osteomyelitis, Benign Tumor and Orthognathic surgery', 'patients undergoing major maxillofacial surgery under general anaesthesia', 'A total of 32 patients were included in this study', '32 patients, 26 male and 06 female were included in the study', 'patient undergoing maxillofacial surgery']",[],"['serum cortisol level', 'Anxiety levels']","[{'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C3164440', 'cui_str': 'Dental hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0011428', 'cui_str': 'Dentigerous cyst'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0225344', 'cui_str': 'Tunica submucosa'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0086692', 'cui_str': 'Neoplasm, benign'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",32.0,0.0208841,"There was statistically highly significant difference seen between the mean values obtained three days prior to surgery and on the day of surgery.
","[{'ForeName': 'Sharvika', 'Initials': 'S', 'LastName': 'Aher', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.'}, {'ForeName': 'Pushkar', 'Initials': 'P', 'LastName': 'Waknis', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.'}, {'ForeName': 'Prathamesh', 'Initials': 'P', 'LastName': 'Bhujbal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.'}, {'ForeName': 'Deeisha', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.'}]",Annals of maxillofacial surgery,['10.4103/ams.ams_20_19']
2843,32855913,Combination of Articaine and Ketamine V/S Articaine Alone After Surgical Extraction of Impacted Third Molars.,"Objective


Local anesthetics are the most effective drugs available for the management of pain while performing operative procedures. This study was performed to compare the clinical efficacy of treatment with local anesthetic articaine (4%) with ketamine and local anesthetic articaine alone (4%) for the relief or prevention of postoperative pain, swelling, and trismus after the surgical extraction of impacted mesioangular third molars.
Materials and Methods


Sixty patients undergoing the extraction of impacted mesioangular mandibular third molars were included in the study. The patients were randomly divided into two groups: local anesthetic alone (LAA) and local anesthetic plus ketamine (LAK).
Results


Facial swelling following surgery on postoperative days was significantly lower in the LAK group than in the LAA group on 3 rd  and 7 th  postoperative days ( P  < 0.05). Mouth opening on the postoperative days was significantly greater in the LAK group than in the LAA group on 3 rd  and 7 th  postoperative days ( P  < 0.05). The pain scores on the visual analog scale at 30 min and 1 h, 4 h, 12 h, and 24 h after the surgery were significantly higher in the LAA group than in the LAK group and there was no significant difference in heart rate, oxygen saturation, and blood pressure in both the groups.
Conclusion


In this present study, the effect of articaine with ketamine in comparison with articaine alone intraoperatively and postoperatively was observed, and it revealed that the combination of articaine with ketamine produced good local anesthesia and provide good postoperative analgesia with less swelling and significantly less trismus.",2020,Facial swelling following surgery on postoperative days was significantly lower in the LAK group than in the LAA group on 3 rd  and 7 th  postoperative days ( P  < 0.05).,['Sixty patients undergoing the extraction of impacted mesioangular mandibular third molars were included in the study'],"['LAK', 'Articaine Alone', 'LAA', 'ketamine', 'articaine with ketamine', 'local anesthetic articaine', 'local anesthetic alone (LAA) and local anesthetic plus ketamine (LAK', 'ketamine and local anesthetic articaine', 'articaine', 'Articaine and Ketamine V/S']","['heart rate, oxygen saturation, and blood pressure', 'pain scores on the visual analog scale', 'relief or prevention of postoperative pain, swelling, and trismus', 'Facial swelling', 'Mouth opening on the postoperative days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",60.0,0.0292461,Facial swelling following surgery on postoperative days was significantly lower in the LAK group than in the LAA group on 3 rd  and 7 th  postoperative days ( P  < 0.05).,"[{'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Dubey', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Kothiwal Dental College and Research Centre, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Kothiwal Dental College and Research Centre, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Kothiwal Dental College and Research Centre, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Shyamalendu', 'Initials': 'S', 'LastName': 'Laskar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Kothiwal Dental College and Research Centre, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Arpit', 'Initials': 'A', 'LastName': 'Vashistha', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Kothiwal Dental College and Research Centre, Moradabad, Uttar Pradesh, India.'}]",Annals of maxillofacial surgery,['10.4103/ams.ams_143_19']
2844,32858371,Effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.,"OBJECTIVE


Patients may be afraid when they receive knowledge that medications are injected into the middle ear through the tympanic membrane using a fine needle during intratympanic treatment. The aim of this study was to evaluate the effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.
STUDY DESIGN


Prospective, Non-randomized, controlled trial.
SETTING


Tertiary academic medical center.
METHODS


A total of 85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus were included in this prospective study. 40 cases received video-assisted information before intratympanic steroid injection in the study group, while 45 cases were verbally informed face-to-face in the control group. Then, patient anxiety was measured using the Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI).
RESULTS


The mean VAS score was 3.58 ± 3.37 (mean rank = 42.09) in the study group and 3.87 ± 3.56 (mean rank = 43.81) in the control group. The mean STAI-S score was 37.03 ± 10.637 in the study group and 39.11 ± 11.783 in the control group. The mean STAI-T score was 40.18 ± 9.151 in the study group and 38.73 ± 11.438 in the control group. It was found that there were no statistically significant differences in the mean VAS, STAI-S and STAI-T scores between the two groups (p > 0.05).
CONCLUSION


We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.",2020,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"['40 cases received', 'Tertiary academic medical center', '85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus', 'patient anxiety']","['video-assisted information prior to intratympanic steroid injection', 'video-assisted information before intratympanic steroid injection']","['mean VAS, STAI-S and STAI-T scores', 'mean STAI-T score', 'mean STAI-S score', 'mean VAS score', 'Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI', 'patient anxiety']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",85.0,0.0321367,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"[{'ForeName': 'Nurdoğan', 'Initials': 'N', 'LastName': 'Ata', 'Affiliation': 'Department of Otorhinolaryngology, KTO Karatay University Medical Faculty, Medicana Hospital, Konya, Turkey. Electronic address: op.dr.na@gmail.com.'}, {'ForeName': 'Necat', 'Initials': 'N', 'LastName': 'Alataş', 'Affiliation': 'Department of Otolaryngology, Uşak University Medical Faculty, Uşak, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Güllüev', 'Affiliation': 'Department of Otorhinolaryngology, Medical Sciences University Konya Training and Research Hospital, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': ""Department of Otolaryngology, Dr. Ali Kemal Belviranlı Maternity and Children's Hospital, Konya, Turkey.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102689']
2845,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2020,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
2846,32858399,Effect of antenatal magnesium sulphate on MRI biomarkers of white matter development at term equivalent age: The magnum study.,"BACKGROUND


Magnesium sulphate given to women immediately prior to very preterm birth protects the perinatal brain, so fewer babies die or develop cerebral palsy. How magnesium sulphate exerts these beneficial effects remains uncertain. The aim of the MagNUM Study was to assess the effect of exposure to antenatal magnesium sulphate on MRI measures of brain white matter microstructure at term equivalent age.
METHODS


Nested cohort study within the randomised Magnesium sulphate at 30 to <34 weeks' Gestational age Neuroprotection Trial (MAGENTA). Mothers at risk of preterm birth at 30 to <34 weeks' gestation were randomised to receive either 4 g of magnesium sulphate heptahydrate [8 mmol magnesium ions], or saline placebo, infused over 30 min when preterm birth was planned or expected within 24 h. Participating babies underwent diffusion tensor MRI at term equivalent age. The main outcomes were fractional anisotropy across the white matter tract skeleton compared using Tract-based Spatial Statistics (TBSS), with adjustment for postmenstrual age at birth and at MRI, and MRI site. Researchers and families were blind to treatment group allocation during data collection and analyses.
FINDINGS


Of the 109 participating babies the demographics of the 60 babies exposed to magnesium sulphate were similar to the 49 babies exposed to placebo. In babies whose mothers were allocated to magnesium sulphate, fractional anisotropy was higher within the corticospinal tracts and corona radiata, the superior and inferior longitudinal fasciculi, and the inferior fronto-occipital fasciculi compared to babies whose mothers were allocated placebo (P < 0.05).
INTERPRETATION


In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function. This may be one mechanism for the neuroprotective effect of magnesium sulphate treatment prior to preterm birth.
FUNDING


Health Research Council of New Zealand.",2020,"In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function.","['109 participating babies', ""Mothers at risk of preterm birth at 30 to <34 weeks' gestation"", ""at 30 to <34 weeks' Gestational age Neuroprotection Trial"", 'babies born preterm', 'white matter development at term equivalent age', 'brain white matter microstructure at term equivalent age']","['magnesium sulphate heptahydrate [8\xa0mmol magnesium ions], or saline placebo', 'magnesium sulphate', 'placebo', 'Magnesium sulphate', 'antenatal magnesium sulphate']","['fractional anisotropy across the white matter tract skeleton compared using Tract-based Spatial Statistics (TBSS), with adjustment for postmenstrual age at birth and at MRI, and MRI site', 'MRI biomarkers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]","[{'cui': 'C0772046', 'cui_str': 'Magnesium sulfate heptahydrate'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C2346927', 'cui_str': 'Magnesium Cation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.260441,"In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Poppe', 'Affiliation': ""Department of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; Centre for the Developing Brain, Department of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Department of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; School of Optometry and Vision Science, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Boardman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom; MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Bastin', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Deib', 'Affiliation': 'Department of Radiology, West Virginia University Hospital, W.Va, United States.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Building 503, Level 2, 85 Park Road, Auckland 1142, New Zealand.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, University of Auckland, Building 503, Level 2, 85 Park Road, Auckland 1142, New Zealand. Electronic address: c.crowther@auckland.ac.nz.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EBioMedicine,['10.1016/j.ebiom.2020.102957']
2847,32858522,"Impact of ""JolinchenKids-Fit and Healthy in Daycare"" on Children's Objectively Measured Physical Activity: A Cluster-Controlled Study.","BACKGROUND


To evaluate a multicomponent health promotion program targeting preschoolers' physical activity (PA).
METHODS


PA of children from 23 German daycare facilities (DFs; 13 intervention DFs, 10 control DFs) was measured via accelerometry at baseline and after 12 months. Children's sedentary time, light PA, and moderate to vigorous PA were estimated. Adherence was tracked with paper-and-pencil calendars. Mixed-model regression analyses were used to assess intervention effects.
RESULTS


PA data were analyzed from 183 (4.2 [0.8] y, 48.1% boys) children. At follow-up, children in DF groups with more than 50% adherence to PA intervention components showed an increase of 9 minutes of moderate to vigorous PA per day (β = 9.28; 95% confidence interval [CI], -0.16 to 18.72) and a 19-minute decrease in sedentary time (β = -19.25; 95% CI, -43.66 to 5.16) compared with the control group, whereas children's PA of those who were exposed to no or less than 50% adherence remained unchanged (moderate to vigorous PA: β = 0.34; 95% CI, -13.73 to 14.41; sedentary time: β = 1.78; 95% CI, -26.54 to 30.09). Notable effects were found in children with migration background.
CONCLUSIONS


Only small benefits in PA outcomes were observed after 1 year. A minimum of 50% adherence to the intervention seems to be crucial for facilitating intervention effects.",2020,"At follow-up, children in DF groups with more than 50% adherence to PA intervention components showed an increase of 9 minutes of moderate to vigorous PA per day (β = 9.28; 95% confidence interval [CI], -0.16 to 18.72) and a 19-minute decrease in sedentary time (β = -19.25; 95% CI, -43.66 to 5.16) compared with the control group, whereas children's PA of those who were exposed to no or less than 50% adherence remained unchanged (moderate to vigorous PA: β = 0.34; 95% CI, -13.73 to 14.41; sedentary time: β = 1.78; 95% CI, -26.54 to 30.09).","['children with migration background', 'PA of children from 23 German daycare facilities (DFs; 13 intervention DFs, 10 control DFs']","['JolinchenKids-Fit and Healthy in Daycare', 'multicomponent health promotion program']","['sedentary time', ""Children's sedentary time, light PA, and moderate to vigorous PA"", 'Physical Activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0601353,"At follow-up, children in DF groups with more than 50% adherence to PA intervention components showed an increase of 9 minutes of moderate to vigorous PA per day (β = 9.28; 95% confidence interval [CI], -0.16 to 18.72) and a 19-minute decrease in sedentary time (β = -19.25; 95% CI, -43.66 to 5.16) compared with the control group, whereas children's PA of those who were exposed to no or less than 50% adherence remained unchanged (moderate to vigorous PA: β = 0.34; 95% CI, -13.73 to 14.41; sedentary time: β = 1.78; 95% CI, -26.54 to 30.09).","[{'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Brandes', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Buck', 'Affiliation': ''}, {'ForeName': 'Marvin N', 'Initials': 'MN', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Pischke', 'Affiliation': ''}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Brandes', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0536']
2848,32858860,Composition of Coloured Gastric Residuals in Extremely Preterm Infants-A Nested Prospective Observational Study.,"Green gastric residuals (GR) are often considered as a sign of feed intolerance and discarded in preterm infants. Probiotics are known to enhance feed tolerance in preterm infants. To assess the composition (primary outcome) and volume of discarded green GRs, and feeding outcomes in extremely preterm (EP) infants in a probiotic trial, composition of pale and dark green GRs in the first two weeks of life from EP infants (<28 weeks) in a randomized controlled trial (RCT: SiMPro) of single vs. three-strain probiotics was assessed. Feeding outcomes included time to full feeds (TFF: 150 mL/kg/day) and duration of parenteral nutrition (PN). EP infants given placebo in our previous probiotic RCT served as the reference group. Analysis involved linear regression modelling with clustered standard errors for repeated measurements. GRs of 74/103 from 39 SiMPro infants (18: single-strain, 21: three-strain) were analyzed. Bile acid content was higher but statistically insignificant (825.79 vs. 338.1 µmol/L;  p  = 0.12) in dark vs. pale green GRs. Mean (95% confidence interval) fat, nitrogen, and carbohydrate loss in GRs over the study period was 0.02 g (0.01-0.03), 0.011 g (0.009-0.013), and 0.05 g (0.04-0.06), respectively. Overall, SiMPro infants had shorter median TFF (10 vs. 14 days,  p  = 0.02) and duration of PN (10 vs. 16 days,  p  = 0.022) compared with control group infants. Z scores for growth parameters at discharge were comparable. Discarding dark green GRs meant higher loss of bile acids during early enteral nutrition in EP infants. Probiotic supplementation was associated with reduced TFF and duration of PN.",2020,"Overall, SiMPro infants had shorter median TFF (10 vs. 14 days,  p  = 0.02) and duration of PN (10 vs. 16 days,  p  = 0.022) compared with control group infants.","['preterm infants', 'EP infants', 'Extremely Preterm Infants', 'GRs of 74/103 from 39 SiMPro infants (18: single-strain, 21: three-strain) were analyzed']","['Discarding dark green GRs', 'Probiotic supplementation', 'placebo']","['nitrogen, and carbohydrate loss in GRs', 'time to full feeds (TFF: 150 mL/kg/day) and duration of parenteral nutrition (PN', 'bile acids', 'composition of pale and dark green GRs', 'shorter median TFF', 'duration of PN', 'TFF and duration of PN', 'Bile acid content']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030232', 'cui_str': 'Pale complexion'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.272969,"Overall, SiMPro infants had shorter median TFF (10 vs. 14 days,  p  = 0.02) and duration of PN (10 vs. 16 days,  p  = 0.022) compared with control group infants.","[{'ForeName': 'Athalye-Jape', 'Initials': 'AJ', 'LastName': 'Gayatri', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Nettleton', 'Initials': 'N', 'LastName': 'Megan', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Ching-Tat', 'Affiliation': 'School of Molecular Sciences, University of Western Australia, Perth 6009, Western Australia, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Elizabeth', 'Affiliation': 'Department of Biostatistics, Women and Infants Research Foundation, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Geddes', 'Initials': 'G', 'LastName': 'Donna', 'Affiliation': 'School of Molecular Sciences, University of Western Australia, Perth 6009, Western Australia, Australia.'}, {'ForeName': 'Simmer', 'Initials': 'S', 'LastName': 'Karen', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}, {'ForeName': 'Patole', 'Initials': 'P', 'LastName': 'Sanjay', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital, Perth 6008, Western Australia, Australia.'}]",Nutrients,['10.3390/nu12092585']
2849,32858977,The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study.,"Spinal cord stimulation may enable recovery of volitional motor control in people with chronic Spinal Cord Injury (SCI). In this study we explored the effects of adding SCS, applied transcutaneously (tSCS) at vertebral levels T10/11, to a sit-to-stand training intervention in people with motor complete and incomplete SCI. Nine people with chronic SCI (six motor complete; three motor incomplete) participated in an 8-week intervention, incorporating three training sessions per week. Participants received either tSCS combined with sit-to-stand training (STIM) or sit-to-stand training alone (NON-STIM). Outcome measures were carried out before and after the intervention. Seven participants completed the intervention (STIM N = 5; NON-STIM N = 2). Post training, improvements in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores were noted in three STIM participants (range 1.0-7.0), with no change in NON-STIM participants. Recovery of volitional lower limb muscle activity and/or movement (with tSCS off) was noted in three STIM participants. Unassisted standing was not achieved in any participant, although standing with minimal assistance was achieved in one STIM participant. This pilot study has shown that the recruitment of participants, intervention and outcome measures were all feasible in this study design. However, some modifications are recommended for a larger trial.",2020,"Post training, improvements in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores were noted in three STIM participants (range 1.0-7.0), with no change in NON-STIM participants.","['people with chronic Spinal Cord Injury (SCI', 'Nine people with chronic SCI (six motor complete; three motor incomplete', 'people with motor complete and incomplete SCI', 'People with Spinal Cord Injury']","['Spinal cord stimulation', 'SCS, applied transcutaneously (tSCS', 'tSCS combined with sit-to-stand training (STIM) or sit-to-stand training alone (NON-STIM', 'Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training']","['Unassisted standing', 'International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",9.0,0.0995996,"Post training, improvements in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores were noted in three STIM participants (range 1.0-7.0), with no change in NON-STIM participants.","[{'ForeName': 'Yazi', 'Initials': 'Y', 'LastName': ""Al'joboori"", 'Affiliation': 'Department of Medical Physics & Biomedical Engineering, UCL, London WC1E 6BT, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Massey', 'Affiliation': 'Aspire CREATe, UCL, Stanmore HA7 4LP, UK.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Knight', 'Affiliation': 'London Spinal Cord Injury Centre, Royal National Orthopaedic Hospital, Stanmore HA7 4LP, UK.'}, {'ForeName': 'Nick de N', 'Initials': 'NN', 'LastName': 'Donaldson', 'Affiliation': 'Department of Medical Physics & Biomedical Engineering, UCL, London WC1E 6BT, UK.'}, {'ForeName': 'Lynsey D', 'Initials': 'LD', 'LastName': 'Duffell', 'Affiliation': 'Department of Medical Physics & Biomedical Engineering, UCL, London WC1E 6BT, UK.'}]",Journal of clinical medicine,['10.3390/jcm9092765']
2850,32855968,Prediction Model of HBsAg Seroclearance in Patients with Chronic HBV Infection.,"Background


Prediction of HBsAg seroclearance, defined as the loss of circulating HBsAg with or without development of antibodies for HBsAg in patients with chronic hepatitis B (CHB), is highly difficult and challenging due to its low incidence. This study is aimed at developing and validating a nomogram for prediction of HBsAg loss in CHB patients.
Methods


We analyzed a total of 1398 patients with CHB. Two-thirds of the patients were randomly assigned to the training set ( n  = 918), and one-third were assigned to the validation set ( n  = 480). Univariate and multivariate analysis by Cox regression analysis was performed using the training set, and the nomogram was constructed. Discrimination and calibration were performed using the training set and validation set.
Results


On multivariate analysis of the training set, independent factors for HBsAg loss including BMI, HBeAg status, HBsAg titer (quantitative HBsAg), and baseline hepatitis B virus (HBV) DNA level were incorporated into the nomogram. The HBsAg seroclearance calibration curve showed an optimal agreement between predictions by the nomogram and actual observation. The concordance index (C-index) of nomogram was 0.913, with confirmation in the validation set where the C-index was 0.886.
Conclusions


We established and validated a novel nomogram that can individually predict HBsAg seroclearance and non-seroclearance for CHB patients, which is clinically unprecedented. This practical prognostic model may help clinicians in decision-making and design of clinical studies.",2020,"The concordance index (C-index) of nomogram was 0.913, with confirmation in the validation set where the C-index was 0.886.
","['CHB patients', 'patients with chronic hepatitis B (CHB', 'Patients with Chronic HBV Infection', '1398 patients with CHB']",[],"['HBsAg loss including BMI, HBeAg status, HBsAg titer (quantitative HBsAg), and baseline hepatitis B virus (HBV) DNA level']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1398.0,0.0224464,"The concordance index (C-index) of nomogram was 0.913, with confirmation in the validation set where the C-index was 0.886.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Laboratory Medicine, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}, {'ForeName': 'Christ-Jonathan', 'Initials': 'CJ', 'LastName': 'Tsia Hin Fong', 'Affiliation': 'Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}, {'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}, {'ForeName': 'Guoli', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}, {'ForeName': 'Xiangyong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}, {'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Jie', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}, {'ForeName': 'Yutian', 'Initials': 'Y', 'LastName': 'Chong', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630 Guangdong Province, China.'}]",BioMed research international,['10.1155/2020/6820179']
2851,32855972,"Tranexamic Acid for Blood Loss after Transforaminal Posterior Lumbar Interbody Fusion Surgery: A Double-Blind, Placebo-Controlled, Randomized Study.","Background


Transforaminal lumbar interbody fusion (TLIF) may result in significant blood loss and an increase in blood transfusion. Though tranexamic acid (TXA) is widely studied for the hemostasis of arthroplasty, there is little information on the use of TXA for TLIF surgery.
Methods


This prospective randomized, double-blind, placebo-controlled trial was conducted to study the influence of TXA (intravenous bolus of 10 mg/kg 15 minutes before skin incision followed by intravenous infusion of 6-8 mg/kg/h up to a total dose of 15 mg/kg during the surgery) on the blood loss and Enhanced Recovery After Surgery (ERAS) after TLIF surgery. 40 patients were randomized into two groups: TXA group (tranexamic acid) and control group (placebo). Baseline characteristics were comparable between the TXA group and the control group before the surgery. Outcomes assessed included blood loss, total postoperative drainage, time for drainage removal, time to ambulation, hospital stay after surgery, postoperative hemoglobin (Hb) one day after surgery, and adverse events.
Results


Compared to patients in the control group after TLIF surgery, patients in the TXA group have significantly reduced intraoperative hemorrhage and time to ambulation after surgery but show similar hospital stay, postoperative drainage, time for drainage removal, postoperative Hb one day after surgery, and adverse events.
Conclusions


TXA shows important ability in controlling blood loss and promoting the ERAS after TLIF surgery.",2020,"Compared to patients in the control group after TLIF surgery, patients in the TXA group have significantly reduced intraoperative hemorrhage and time to ambulation after surgery but show similar hospital stay, postoperative drainage, time for drainage removal, postoperative Hb one day after surgery, and adverse events.
","['after Transforaminal Posterior Lumbar Interbody Fusion Surgery', '40 patients']","['Tranexamic Acid', 'tranexamic acid (TXA', 'TXA (intravenous bolus of 10\u2009mg/kg 15 minutes before skin incision', 'placebo', '\n\n\nTransforaminal lumbar interbody fusion (TLIF', 'TXA group (tranexamic acid) and control group (placebo', 'Placebo', 'TXA']","['blood loss, total postoperative drainage, time for drainage removal, time to ambulation, hospital stay after surgery, postoperative hemoglobin', 'blood loss and Enhanced Recovery', 'hospital stay, postoperative drainage, time for drainage removal, postoperative Hb one day after surgery, and adverse events', 'blood transfusion', 'intraoperative hemorrhage and time to ambulation', 'Blood Loss', 'blood loss']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0079027', 'cui_str': 'Intraoperative hemorrhage'}]",40.0,0.405681,"Compared to patients in the control group after TLIF surgery, patients in the TXA group have significantly reduced intraoperative hemorrhage and time to ambulation after surgery but show similar hospital stay, postoperative drainage, time for drainage removal, postoperative Hb one day after surgery, and adverse events.
","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China 400016.'}, {'ForeName': 'Yuanqiang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China 400016.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China 400016.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Ou', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China 400016.'}, {'ForeName': 'Jinqiu', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China 400016.'}]",BioMed research international,['10.1155/2020/8516504']
2852,32856005,Grant Report on d-Serine Augmentation of Neuroplasticity-Based Auditory Learning in Schizophrenia  † .,"We report on the rationale and design of an ongoing NIMH sponsored R61-R33 project in schizophrenia/schizoaffective disorder. This project studies augmenting the efficacy of auditory neuroplasticity cognitive remediation (AudRem) with d-serine, an  N -methyl-d-aspartate-type glutamate receptor (NMDAR) glycine-site agonist. We operationalize improved (smaller) thresholds in pitch (frequency) between successive auditory stimuli after AudRem as improved plasticity, and mismatch negativity (MMN) and auditory θ as measures of functional target engagement of both NMDAR agonism and plasticity. Previous studies showed that AudRem alone produces significant, but small cognitive improvements, while d-serine alone improves symptoms and MMN. However, the strongest results for plasticity outcomes (improved pitch thresholds, auditory MMN and θ) were found when combining d-serine and AudRem. AudRem improvements correlated with reading and other auditory cognitive tasks, suggesting plasticity improvements are predictive of functionally relevant outcomes. While d-serine appears to be efficacious for acute AudRem enhancement, the optimal dose remains an open question, as does the ability of combined d-serine + AudRem to produce sustained improvement. In the ongoing R61, 45 schizophrenia patients will be randomized to receive three placebo-controlled, double-blind d-serine + AudRem sessions across three separate 15 subject dose cohorts (80/100/120 mg/kg). Successful completion of the R61 is defined by ≥moderate effect size changes in target engagement and correlation with function, without safety issues. During the three-year R33, we will assess the sustained effects of d-serine + AudRem. In addition to testing a potentially viable treatment, this project will develop a methodology to assess the efficacy of novel NMDAR modulators, using d-serine as a ""gold-standard"".",2020,"We operationalize improved (smaller) thresholds in pitch (frequency) between successive auditory stimuli after AudRem as improved plasticity, and mismatch negativity (MMN) and auditory θ as measures of functional target engagement of both NMDAR agonism and plasticity.","['schizophrenia/schizoaffective disorder', '45 schizophrenia patients']","['auditory neuroplasticity cognitive remediation (AudRem) with d-serine, an  N -methyl-d-aspartate-type glutamate receptor (NMDAR) glycine-site agonist', 'Neuroplasticity-Based Auditory Learning', 'placebo']","['symptoms and MMN', 'plasticity, and mismatch negativity (MMN) and auditory θ as measures of functional target engagement of both NMDAR agonism and plasticity', 'plasticity outcomes (improved pitch thresholds, auditory MMN and θ', 'small cognitive improvements', 'auditory cognitive tasks']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C1880218', 'cui_str': 'serine, D-'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0061465', 'cui_str': 'Glutamate Receptor'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",45.0,0.0788437,"We operationalize improved (smaller) thresholds in pitch (frequency) between successive auditory stimuli after AudRem as improved plasticity, and mismatch negativity (MMN) and auditory θ as measures of functional target engagement of both NMDAR agonism and plasticity.","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'de la Garrigue', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Glasser', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Dias', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Shope', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gangwisch', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Mayer', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brazis', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Heloise M', 'Initials': 'HM', 'LastName': 'De Baun', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wolfer', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Dalton', 'Initials': 'D', 'LastName': 'Bermudez', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Arnold', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rette', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Amir M', 'Initials': 'AM', 'LastName': 'Meftah', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Conant', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'New York State Psychiatric Institute, New York, NY 10032, USA.'}]",Journal of psychiatry and brain science,[]
2853,32856190,"Effect of folic acid combined with docosahexaenoic acid intervention on mild cognitive impairment in elderly: a randomized double-blind, placebo-controlled trial.","PURPOSE


This study aimed to assess the effects of folic acid (FA) combined with a docosahexaenoic acid (DHA) intervention on the cognitive function and inflammatory cytokines in elderly subjects with mild cognitive impairment (MCI).
METHODS


This randomized, double-blind, placebo-controlled trial recruited 240 individuals with MCI in Tianjin, China, and randomly allocated into 4 groups: FA + DHA (FA 800 μg/d + DHA 800 mg/d), FA (FA 800 μg/d), DHA (DHA 800 mg/d), and placebo. Cognitive function, serum folate and homocysteine (Hcy), plasma DHA and inflammatory cytokines levels were measured at baseline and 6 months.
RESULTS


Daily oral FA, DHA and their combined use for 6 months significantly improved the full-scale intelligence quotient (FSIQ) and some subtests of Wechsler Adult Intelligence Scale compared to the placebo. The increases of FSIQ, arithmetic, picture completion scores in the FA group and picture completion, block design scores in the DHA group were significantly less than that in the FA combined DHA group (P < 0.05). Meanwhile, daily oral FA, DHA and their combined use for 6 months significantly decreased plasma inflammatory cytokines compared to the placebo. The changes of interleukin-1β levels in the FA group and interleukin-6 levels in the DHA group were significantly less than that in the FA + DHA group (P < 0.05).
CONCLUSIONS


Daily oral FA, DHA and their combined use for 6 months can significantly improve cognitive function and decrease plasma inflammatory cytokines in MCI individuals. The combination of FA and DHA was more beneficial than each individual nutrient on their own.",2020,"Meanwhile, daily oral FA, DHA and their combined use for 6 months significantly decreased plasma inflammatory cytokines compared to the placebo.","['mild cognitive impairment in elderly', '240 individuals with MCI in Tianjin, China, and randomly allocated into 4 groups', 'elderly subjects with mild cognitive impairment (MCI']","['docosahexaenoic acid intervention', 'folic acid', 'placebo', 'FA\u2009+\u2009DHA (FA 800\xa0μg/d\u2009+\u2009DHA 800\xa0mg/d), FA (FA 800\xa0μg/d), DHA (DHA 800\xa0mg/d), and placebo', 'folic acid (FA) combined with a docosahexaenoic acid (DHA) intervention']","['picture completion, block design scores', 'interleukin-6 levels', 'cognitive function and inflammatory cytokines', 'full-scale intelligence quotient (FSIQ) and some subtests of Wechsler Adult Intelligence Scale', 'cognitive function', 'changes of interleukin-1β levels', 'Cognitive function, serum folate and homocysteine\xa0(Hcy), plasma DHA and inflammatory cytokines levels', 'FSIQ, arithmetic, picture completion scores', 'plasma inflammatory cytokines']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0204456', 'cui_str': 'Wechsler adult intelligence scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",240.0,0.209928,"Meanwhile, daily oral FA, DHA and their combined use for 6 months significantly decreased plasma inflammatory cytokines compared to the placebo.","[{'ForeName': 'Mengyue', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, No 22 Qixiangtai Road, Heping District, Tianjin, 300070, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, No 22 Qixiangtai Road, Heping District, Tianjin, 300070, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, No 22 Qixiangtai Road, Heping District, Tianjin, 300070, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Bai', 'Affiliation': 'Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, No 22 Qixiangtai Road, Heping District, Tianjin, 300070, China.'}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'Xinkaihe Community Health Service Center, Hebei District, Tianjin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Social Medicine and Health Management, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xinyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, No 22 Qixiangtai Road, Heping District, Tianjin, 300070, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, No 22 Qixiangtai Road, Heping District, Tianjin, 300070, China. liuhuan@tmu.edu.cn.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, No 22 Qixiangtai Road, Heping District, Tianjin, 300070, China. huangguowei@tmu.edu.cn.'}]",European journal of nutrition,['10.1007/s00394-020-02373-3']
2854,32856209,"The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial.","PURPOSE


Although corticosteroids are frequently used in patients with advanced cancer, few studies have examined the impact of these drugs on patient-reported sleep. We aimed to examine the short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer.
METHODS


Patient-reported sleep was a predefined secondary outcome in a prospective, randomized, placebo-controlled, double-blind trial that evaluated the analgesic efficacy of corticosteroids in advanced cancer patients (18+), using opioids, and having pain ≥ 4 past 24 h (NRS 0-10). Patients were randomized to the methylprednisolone group with methylprednisolone 16 mg × 2/day or placebo for 7 days. The EORTC QLQ-C30 (0-100) and the Pittsburgh Sleep Quality Index questionnaire (PSQI) (0-21) were used to assess the impact of corticosteroids on sleep at baseline and at day 7.
RESULTS


Fifty patients were randomized of which 25 were analyzed in the intervention group and 22 in the control group. Mean age was 64 years, mean Karnofsky performance status was 67 (SD 13.3), 51% were female, and the mean oral daily morphine equivalent dose was 223 mg (SD 222.77). Mean QLQ-C30 sleep score at baseline was 29.0 (SD 36.7) in the methylprednisolone group and 24.2 (SD 27.6) in the placebo group. At day 7, there was no difference between the groups on QLQ-C30 sleep score (methylprednisolone 20.3 (SD 32.9); placebo 28.8 (SD 33.0), p = 0.173). PSQI showed similar results.
CONCLUSIONS


Methylprednisolone 16 mg twice daily for 7 days had no impact on patient-reported sleep in this cohort of patients with advanced cancer.
TRIAL REGISTRATION


Clinical trial information NCT00676936 (13.05.2008).",2020,"Methylprednisolone 16 mg twice daily for 7 days had no impact on patient-reported sleep in this cohort of patients with advanced cancer.
","['Patient-reported sleep', 'patients with advanced cancer', 'Fifty patients', 'advanced cancer patients (18+), using opioids, and having pain ≥\u20094 past 24\xa0h (NRS 0-10', 'Mean age was 64\xa0years, mean Karnofsky performance status was 67 (SD 13.3), 51% were female, and the mean oral daily morphine equivalent dose was 223\xa0mg (SD 222.77']","['corticosteroids', 'Methylprednisolone', 'methylprednisolone', 'placebo', 'methylprednisolone 16']","['Pittsburgh Sleep Quality Index questionnaire (PSQI', 'Mean QLQ-C30 sleep score', 'patient-reported sleep', 'QLQ-C30 sleep score', 'analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.537469,"Methylprednisolone 16 mg twice daily for 7 days had no impact on patient-reported sleep in this cohort of patients with advanced cancer.
","[{'ForeName': 'Gunnhild', 'Initials': 'G', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU Norwegian University of Science and Technology, Postbox 8905, N-7491, Trondheim, Norway. gunnhild.jakobsen@ntnu.no.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Neuromedicine and Movement Science, NTNU - Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marianne Jensen', 'Initials': 'MJ', 'LastName': 'Hjermstad', 'Affiliation': 'Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan Henrik', 'Initials': 'JH', 'LastName': 'Rosland', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Aass', 'Affiliation': 'Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Albert', 'Affiliation': 'Sørlandet Hospital Kristiansand, Kristiansand, Norway.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Kaasa', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU Norwegian University of Science and Technology, Postbox 8905, N-7491, Trondheim, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fayers', 'Affiliation': 'Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Klepstad', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Ørnulf', 'Initials': 'Ø', 'LastName': 'Paulsen', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05693-6']
2855,32856226,"Comparison of Blood Glucose Variability Between Exenatide and Biphasic Insulin Aspart 30 in Chinese Participants with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy: A Multicenter, Open-Label, Randomized Trial.","INTRODUCTION


To compare blood glucose variability (GV) in Chinese participants with type 2 diabetes mellitus (T2DM) whose blood glucose levels are inadequately controlled with metformin monotherapy after twice-daily exenatide or biphasic insulin aspart 30 (BIAsp30).
METHODS


In this 16-week multicenter, randomized clinical trial, 104 participants were randomized 1:1 to receive exenatide (exenatide group) or BIAsp30 (BIAsp30 group) twice daily. All participants continued metformin treatment. The primary outcome was the change in GV as measured by a continuous glucose monitoring system (CGMS) from baseline to 16 weeks.
RESULTS


At 16 weeks, both the Exenatide and BIAsp30 groups effectively decreased mean glucose (MG), but neither group changed the mean amplitude of glycemic excursion (MAGE), largest amplitude of glycemic excursion (LAGE), mean of daily difference (MODD), or standard deviation of blood glucose (SDBG). The decrease in 2-h post-breakfast glucose excursions was greater in the Exenatide group compared to the BIAsp30 group, with a least square (LS) mean difference [95% CI] of (1.58 [0.53, 2.63]). Exenatide also significantly reduced 2-h post-lunch glucose excursion compared to BIAsp30 (LS mean difference [95% CI], 1.19 [0.18, 2.20]). The Exenatide group had significantly reduced body weight and body mass index (BMI), while the BIAsp30 group had increased weight and had no change in BMI. Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
CONCLUSION


Although there was no difference in change of GV between Exenatide and BIAsp30, exenatide provided more improvement in postprandial glucose excursion and weight control, without increasing the risk of hypoglycemia in Chinese patients with T2DM whose blood glucose was inadequately controlled with metformin. These findings may provide new options for patients who choose further hypoglycemic treatment, especially in patients with obesity who have large postprandial plasma glucose excursions.
TRIAL REGISTRATION


ClinicalTrials.gov indentifier: NCT02449603.",2020,"Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
","['104 participants', 'Chinese participants with type 2 diabetes mellitus (T2DM) whose blood glucose levels are inadequately controlled with', 'Chinese patients with T2DM whose blood glucose was inadequately controlled with', 'Chinese Participants with Type 2 Diabetes Inadequately Controlled with', 'patients who choose further hypoglycemic treatment, especially in patients with obesity who have large postprandial plasma glucose excursions']","['exenatide or biphasic insulin aspart 30 (BIAsp30', 'Metformin Monotherapy', 'metformin monotherapy', 'Exenatide', 'Exenatide and Biphasic Insulin Aspart', 'metformin', 'exenatide (exenatide group) or BIAsp30 (BIAsp30 group) twice daily']","['BMI', 'weight', 'change in GV as measured by a continuous glucose monitoring system (CGMS', '2-h post-breakfast glucose excursions', 'tolerated with no serious hypoglycemic events', 'hypoglycemic events', 'risk of hypoglycemia', 'blood glucose variability (GV', 'Blood Glucose Variability', 'mean amplitude of glycemic excursion (MAGE), largest amplitude of glycemic excursion (LAGE), mean of daily difference (MODD), or standard deviation of blood glucose (SDBG', '2-h post-lunch glucose excursion', 'body weight and body mass index (BMI', 'mean glucose (MG', 'postprandial glucose excursion and weight control']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C2003521', 'cui_str': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0356369', 'cui_str': 'Biphasic insulin'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}]",104.0,0.0577427,"Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Shaanxi Aerospace Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xi'an Chang an Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, Yan'an People's Hospital, Yan'an, Shaanxi, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ming', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kaiyan', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Shangluo Central Hospital, Shangluo, Shaanxi, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhufang', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': ""Department of Endocrinology, Xi'an Central Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qingzhen', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Endocrinology, Xi'an Gaoxin Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China. qiuheji@hotmail.com.""}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00904-z']
2856,32856272,Single versus dual blockade of the renin-angiotensin system in patients with IgA nephropathy.,"BACKGROUND


Inhibitors of the renin-angiotensin system (RAS) are cornerstones of supportive therapy in patients with IgA nephropathy (IgAN). We analyzed the effects of single versus dual RAS blockaQueryde during our randomized STOP-IgAN trial.
METHODS


STOP-IgAN participants with available successive information on their RAS treatment regimen and renal outcomes during the randomized 3-year trial phase were stratified post hoc into two groups, i.e. patients under continuous single or dual RAS blocker therapy over the entire 3 years of the trial phase. Primary and secondary STOP-IgAN trial endpoints, i.e. frequencies of full clinical remission, eGFR-loss ≥ 15 and ≥ 30 ml/min/1.73 m 2  and ESRD onset, were analyzed by logistic regression and linear mixed effects models.
RESULTS


Among the 112 patients included in the present analysis, 82 (73%) were maintained on single and 30 (27%) on dual RAS inhibitor therapy throughout the trial. Neither RAS blocker strategy significantly affected full clinical remission, eGFR-loss rates, onset of ESRD. Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase. This was particularly evident in patients without additional immunosuppression during the randomized trial phase, where proteinuria increased by 0.2 g/g creatinine in the dual RAS blockade group. In contrast, proteinuria decreased in patients under single RAS blocker therapy by 0.3 g/g creatinine. The course of eGFR remained stable and did not differ between the RAS treatment strategies.
CONCLUSION


In the STOP-IgAN cohort, neither RAS blocker regimen altered renal outcomes. Patients on dual RAS blockade even exhibited higher proteinuria over the 3-year trial phase.",2020,Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase.,"['patients with IgA nephropathy (IgAN', 'STOP-IgAN participants with available successive information on their RAS treatment regimen and renal outcomes during the randomized 3-year trial phase were stratified post hoc into two groups, i.e. patients under', '112 patients included in the present analysis, 82 (73%) were maintained on single and 30 (27%) on dual RAS inhibitor therapy throughout the trial', 'patients with IgA nephropathy']","['renin-angiotensin system', 'renin-angiotensin system (RAS', 'dual RAS blockade', 'continuous single or dual RAS blocker therapy', 'RAS blocker']","['frequencies of full clinical remission, eGFR-loss\u2009≥\u200915 and\u2009≥', 'renal outcomes', 'full clinical remission, eGFR-loss rates, onset of ESRD', 'Proteinuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",112.0,0.114681,Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase.,"[{'ForeName': 'David Paul', 'Initials': 'DP', 'LastName': 'Lennartz', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Seikrit', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wied', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fitzner', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eitner', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rauen', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany. jfloege@ukaachen.de.'}]",Journal of nephrology,['10.1007/s40620-020-00836-8']
2857,32856285,"Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial.","BACKGROUND


The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation.
OBJECTIVES


The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN.
METHODS


A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone.
RESULTS


Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality.
CONCLUSION


Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings.
REGISTRATION


Pan African Clinical Trial Registry identifier number PACTR201902691230243.",2020,The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups.,"['severe persistent pulmonary hypertension (PPHN', 'neonates with PPHN', 'neonates with severe PPHN', 'neonates with PPHN were divided into three groups of 20 patients each: group 1 received', 'Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings']","['sildenafil', 'sildenafil and milrinone', 'oral sildenafil starting at 0.5\xa0mg/kg every 6\xa0h to a target maintenance dose of 2\xa0mg/kg every 6\xa0h; group 2 received intravenous milrinone 0.5\xa0μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone', 'milrinone', 'Milrinone Plus Sildenafil']","['mortality', 'pulmonary artery systolic pressure', 'oxygenation index']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}]",,0.401337,The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups.,"[{'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'El-Ghandour', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Bahaa', 'Initials': 'B', 'LastName': 'Hammad', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ghanem', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Manal A M', 'Initials': 'MAM', 'LastName': 'Antonios', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt. malakmanal@yahoo.com.'}]",Paediatric drugs,['10.1007/s40272-020-00412-4']
2858,32856298,Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.,"BACKGROUND


Oral 5-aminosalicylic acid (5-ASA; also known as mesalazine or mesalamine) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. In an earlier version of this review, we found that 5-ASA drugs were more effective than placebo for maintenance of remission of ulcerative colitis (UC), but had a significant therapeutic inferiority relative to SASP. In this version, we have rerun the search to bring the review up to date.
OBJECTIVES


To assess the efficacy, dose-responsiveness, and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators for maintenance of remission in quiescent UC and to compare the efficacy and safety of once-daily dosing of oral 5-ASA with conventional (two or three times daily) dosing regimens.
SEARCH METHODS


We performed a literature search for studies on 11 June 2019 using MEDLINE, Embase, and the Cochrane Library. In addition, we searched review articles and conference proceedings.
SELECTION CRITERIA


We included randomized controlled trials with a minimum treatment duration of six months. We considered studies of oral 5-ASA therapy for treatment of participants with quiescent UC compared with placebo, SASP, or other 5-ASA formulations. We also included studies that compared once-daily 5-ASA treatment with conventional dosing of 5-ASA and 5-ASA dose-ranging studies.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. The primary outcome was the failure to maintain clinical or endoscopic remission. Secondary outcomes were adherence, adverse events (AE), serious adverse events (SAE), withdrawals due to AEs, and withdrawals or exclusions after entry. Trials were separated into five comparison groups: 5-ASA versus placebo, 5-ASA versus SASP, once-daily dosing versus conventional dosing, 5-ASA (balsalazide, Pentasa, and olsalazine) versus comparator 5-ASA formulation (Asacol and Salofalk), and 5-ASA dose-ranging. We calculated the risk ratio (RR) and 95% confidence interval (CI) for each outcome. We analyzed data on an intention-to-treat basis, and used GRADE to assess the overall certainty of the evidence.
MAIN RESULTS


The search identified 44 studies (9967 participants). Most studies were at low risk of bias. Ten studies were at high risk of bias. Seven of these studies were single-blind and three were open-label. 5-ASA is more effective than placebo for maintenance of clinical or endoscopic remission. About 37% (335/907) of 5-ASA participants relapsed at six to 12 months compared to 55% (355/648) of placebo participants (RR 0.68, 95% CI 0.61 to 0.76; 8 studies, 1555 participants; high-certainty evidence). Adherence to study medication was not reported for this comparison. SAEs were reported in 1% (6/550) of participants in the 5-ASA group compared to 2% (5/276) of participants in the placebo group at six to 12 months (RR 0.60, 95% CI 0.19 to 1.84; 3 studies, 826 participants; low-certainty evidence). There is probably little or no difference in AEs at six to 12 months' follow-up (RR 0.93, 95% CI 0.73 to 1.18; 5 studies, 1132 participants; moderate-certainty evidence). SASP is more effective than 5-ASA for maintenance of remission. About 48% (416/871) of 5-ASA participants relapsed at six to 18 months compared to 43% (336/784) of SASP participants (RR 1.14, 95% CI 1.03 to 1.27; 12 studies, 1655 participants; high-certainty evidence). Adherence to study medication and SAEs were not reported for this comparison. There is probably little or no difference in AEs at six to 12 months' follow-up (RR 1.07, 95% CI 0.82 to 1.40; 7 studies, 1138 participants; moderate-certainty evidence). There is little or no difference in clinical or endoscopic remission rates between once-daily and conventionally dosed 5-ASA. About 37% (717/1939) of once-daily participants relapsed over 12 months compared to 39% (770/1971) of conventional-dosing participants (RR 0.94, 95% CI 0.88 to 1.01; 10 studies, 3910 participants; high-certainty evidence). There is probably little or no difference in medication adherence rates. About 10% (106/1152) of participants in the once-daily group failed to adhere to their medication regimen compared to 8% (84/1154) of participants in the conventional-dosing group (RR 1.18, 95% CI 0.72 to 1.93; 9 studies, 2306 participants; moderate-certainty evidence). About 3% (41/1587) of participants in the once-daily group experienced a SAE compared to 2% (35/1609) of participants in the conventional-dose group at six to 12 months (RR 1.20, 95% CI 0.77 to 1.87; moderate-certainty evidence). There is little or no difference in the incidence of AEs at six to 13 months' follow-up (RR 0.98, 95% CI 0.92 to 1.04; 8 studies, 3497 participants; high-certainty evidence). There may be little or no difference in the efficacy of different 5-ASA formulations. About 44% (158/358) of participants in the 5-ASA group relapsed at six to 18 months compared to 41% (142/349) of participants in the 5-ASA comparator group (RR 1.08, 95% CI 0.91 to 1.28; 6 studies, 707 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS


There is high-certainty evidence that 5-ASA is superior to placebo for maintenance therapy in UC. There is high-certainty evidence that 5-ASA is inferior compared to SASP. There is probably little or no difference between 5-ASA and placebo, and 5-ASA and SASP in commonly reported AEs such as flatulence, abdominal pain, nausea, diarrhea, headache, and dyspepsia. Oral 5-ASA administered once daily has a similar benefit and harm profile as conventional dosing for maintenance of remission in quiescent UC.",2020,There is little or no difference in clinical or endoscopic remission rates between once-daily and conventionally dosed 5-ASA.,"['participants with quiescent UC', '11 June 2019 using MEDLINE, Embase, and the Cochrane Library', 'ulcerative colitis']","['5-ASA and placebo', '5-aminosalicylic acid (5-ASA', '5-ASA', 'sulfasalazine (SASP', 'Oral 5-aminosalicylic acid', 'mesalazine or mesalamine', 'oral 5-ASA therapy', 'placebo', 'placebo, SASP, or 5-ASA comparators', 'oral 5-ASA', 'placebo, SASP', 'SASP', 'Oral 5-ASA', '5-ASA versus placebo, 5-ASA versus SASP, once-daily dosing versus conventional dosing, 5-ASA (balsalazide, Pentasa, and olsalazine) versus comparator 5-ASA formulation (Asacol and Salofalk), and 5-ASA dose-ranging']","['medication adherence rates', 'efficacy and safety', 'adherence, adverse events (AE), serious adverse events (SAE), withdrawals due to AEs, and withdrawals or exclusions after entry', 'failure to maintain clinical or endoscopic remission', 'SAE', 'clinical or endoscopic remission rates', 'remission of ulcerative colitis (UC', 'risk ratio (RR', 'SAEs', 'flatulence, abdominal pain, nausea, diarrhea, headache, and dyspepsia']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0025141', 'cui_str': 'MEDLINE'}, {'cui': 'C0023621', 'cui_str': 'Library'}]","[{'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C1504637', 'cui_str': 'TXN protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0052940', 'cui_str': 'balsalazide'}, {'cui': 'C0678171', 'cui_str': 'Pentasa'}, {'cui': 'C0069454', 'cui_str': 'olsalazine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0678172', 'cui_str': 'Asacol'}, {'cui': 'C4083158', 'cui_str': 'Salofalk'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}]",9967.0,0.617432,There is little or no difference in clinical or endoscopic remission rates between once-daily and conventionally dosed 5-ASA.,"[{'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD000544.pub5']
2859,32856353,Stress management training program for stress reduction and coping improvement in public health nurses: A randomized controlled trial.,"AIMS


This study aimed to evaluate the effect of the stress management interventional program in reducing occupational stress and improving coping strategies among public health nurses.
DESIGN


A double-blind, cluster-randomized approach was used as a randomization method for this study to evaluate the stress management interventional program.
METHODS


A cluster-randomized controlled trial was carried out in eight comprehensive healthcare centres in Amman city, Jordan; four centres were randomly assigned to each experimental and control group. One hundred and seventy nurses were selected randomly from March 2019 - August 2019 and data were collected by using the Nursing Stress Scale & brief COPE over three data collection times. Both descriptive and inferential statistics (repeated measure ANOVA, Independent t test, and chi-squared) were used to answer the research questions of this study.
RESULTS


The results showed that both the levels of occupational stress and coping strategies were significantly different between the two study groups over the three data collection points (p < 0.05).
CONCLUSION


Based on the findings of this study, the stress management program is an effective non-invasive method that can be used to reduce stress levels and improve coping strategies for public health nurses. The implementation of stress management interventions in health care is likely to help nurses manage occupational stress in practice.
IMPACT


Nurses suffer from a high level of occupational stress. In particular, approximately74% of nurses experience severe occupational stress, which can lead to many mental and physical disorders. However, nurses were less able to utilize the correct stress preventive strategies due to gaps in knowledge, skills, and awareness. This study contributed to the provision of empirical evidence of the effectiveness of the stress management program in reducing occupational stress and improving coping strategies among public health nurses. A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03833986.",2020,"A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
","['public health nurses', 'One hundred and seventy nurses', 'eight comprehensive healthcare centres in Amman city, Jordan; four centres']","['stress management interventional program', 'stress management program', 'Stress management training program']","['levels of occupational stress and coping strategies', 'occupational stress']","[{'cui': 'C0034022', 'cui_str': 'Public health nurse'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",8.0,0.0279992,"A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
","[{'ForeName': ""Ja'far M"", 'Initials': 'JM', 'LastName': 'Alkhawaldeh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Nursing and Rehabilitation, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Kim Lam', 'Initials': 'KL', 'LastName': 'Soh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Nursing and Rehabilitation, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Mukhtar', 'Affiliation': 'Faculty of Medicines and Health Sciences, Department of Psychiatry, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Ooi Cheow', 'Initials': 'OC', 'LastName': 'Peng', 'Affiliation': 'Faculty of Medicines and Health Sciences, Department of Medicine, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Hamzeh M', 'Initials': 'HM', 'LastName': 'Alkhawaldeh', 'Affiliation': 'King Hussein Medical Center, Amman, Jordan.'}, {'ForeName': 'Rasmieh', 'Initials': 'R', 'LastName': 'Al-Amer', 'Affiliation': 'School of Nursing and Midwifery, Isra University/Western Sydney University, Amman, Jordan.'}, {'ForeName': 'Huda A', 'Initials': 'HA', 'LastName': 'Anshasi', 'Affiliation': 'School of Nursing, The University of Jordan, Amman, Jordan.'}]",Journal of advanced nursing,['10.1111/jan.14506']
2860,32856379,Daily activities simulation: Improving nursing students' attitudes toward older patients.,"AIM


This study aims to evaluate the effects of daily life activities simulation on the attitudes of first-year nursing students toward older adults within the scope of geriatric nursing.
METHODS


The study was carried out using a pretest-posttest, quasi-experimental design. First-year undergraduate students (N = 119) of a nursing faculty constituted the study sample. The students were divided into two groups as intervention and control groups. The intervention group performed the daily life activities simulation. Data were collected by using Kogan's Attitudes Towards old People Scale (KAOP) and Positive and Negative Ageism Scale (PNAS). SPSS Ver. 22.00 software was used for statistical analysis. Chi-square test, and t test were used for comparative statistics.
RESULTS


Most of the participants were female, and mean age was 20.96 ± 3.24. Intergroup comparison of the KAOP and PNAS scores reveals a statistically significant difference between the pretest and posttest scores for the simulation group (p ˂ .05). The posttest KOAP and PNAS scores of the simulation and control groups were statistically significantly different (p ˂ .05).
CONCLUSION


Daily life activities simulation is an effective method to improve nursing students' positive attitudes toward older adults. Participant feedback from our study shows that the simulation increased empathy and awareness of geriatric nursing.",2020,"The posttest KOAP and PNAS scores of the simulation and control groups were statistically significantly different (p ˂ .05).
","[""nursing students' attitudes toward older patients"", 'First-year undergraduate students (N = 119) of a nursing faculty constituted the study sample', ""nursing students' positive attitudes toward older adults"", 'participants were female, and mean age was 20.96\u2009±\u20093.24', 'attitudes of first-year nursing students toward older adults within the scope of geriatric nursing']","['Daily activities simulation', 'daily life activities simulation']","['KAOP and PNAS scores', 'Towards old People Scale (KAOP) and Positive and Negative Ageism Scale (PNAS', 'posttest KOAP and PNAS scores']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015538', 'cui_str': 'Nurse teacher'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017466', 'cui_str': 'Care of the elderly nurse'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0242449', 'cui_str': 'Age Discrimination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0145787,"The posttest KOAP and PNAS scores of the simulation and control groups were statistically significantly different (p ˂ .05).
","[{'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Demirtas', 'Affiliation': 'Gulhane Faculty of Nursing, Department of Internal Medicine Nursing, University of Health Sciences Turkey, Ankara, Turkey.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'Gulhane Faculty of Nursing, Fundamentals of Nursing Department, University of Health Sciences Turkey, Ankara, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12375']
2861,32856566,A group positive psychology intervention for cancer survivors and caregivers: A pilot study of Activating Happiness©.,"The purpose of this study was to examine the feasibility and potential concept of a 4-week positive psychology group intervention (Activating Happiness©) for cancer survivors and caregivers that emphasized mindfulness, self-compassion, and gratitude. Nine facilitators led 6 intervention groups for 49 participants (35 cancer survivors, 14 caregivers). Of eligible participants, 63% enrolled and of those, 89% completed all study activities. Participants completed self-report measures at baseline, after the second and final sessions, and 3-month post-intervention, and provided qualitative feedback after the final session. Qualitative data demonstrated that participants found the intervention acceptable. The intervention's potential proof-of-concept was supported by benchmarking outcomes against those reported in randomized controlled trials, with effect sizes for mindfulness, self-compassion, anxiety, and depression for caregivers and survivors, and for pain for survivors comparable to size estimates for efficacy in clinical trials.",2020,"Participants completed self-report measures at baseline, after the second and final sessions, and 3-month post-intervention, and provided qualitative feedback after the final session.","['49 participants (35 cancer survivors, 14 caregivers', 'cancer survivors and caregivers that emphasized mindfulness, self-compassion, and gratitude', 'cancer survivors and caregivers', 'Of eligible participants, 63% enrolled and of those, 89% completed all study activities']","['psychology intervention', 'Activating Happiness', 'positive psychology group intervention (Activating Happiness©']",[],"[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.0534233,"Participants completed self-report measures at baseline, after the second and final sessions, and 3-month post-intervention, and provided qualitative feedback after the final session.","[{'ForeName': 'Trisha L', 'Initials': 'TL', 'LastName': 'Raque-Bogdan', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ash-Lee', 'Affiliation': 'Rocky Mountain Cancer Centers, Denver, CO, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Rocky Mountain Cancer Centers, Denver, CO, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Joseph', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Solberg', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Owen', 'Affiliation': 'University of Denver, Denver, CO, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1801943']
2862,32856597,Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial.,"BACKGROUND


The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use.
OBJECTIVE


This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months.
METHODS


Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated.
RESULTS


Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring-measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001).
CONCLUSIONS


Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381.",2020,">250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively.","['people with type 2 diabetes (T2D', 'Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female', 'Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019', 'Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic']",['telemedicine consultation with a clinic endocrinologist'],"['systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides', 'change in HbA1c', 'weight and blood pressure', 'hypoglycemia', 'HbA1c, increased TIR, decreased time in hyperglycemia', 'Mean weight', 'Glycemic Outcomes', 'Continuous glucose monitoring-measured (n=43) percent time in range (TIR', 'blood pressure and serum lipids', 'change in weight and in RT-CGM glycemic metrics', 'HbA1c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0259863', 'cui_str': 'Endocrinologist'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",55.0,0.151487,">250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively.","[{'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Majithia', 'Affiliation': 'Department of Medicine and Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, CA, United States.'}, {'ForeName': 'Coco M', 'Initials': 'CM', 'LastName': 'Kusiak', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Armento Lee', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'Francis R', 'Initials': 'FR', 'LastName': 'Colangelo', 'Affiliation': 'Allegheny Health Network, Monroeville, PA, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Romanelli', 'Affiliation': 'Sutter Health, Palo Alto, CA, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Robertson', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Erani', 'Affiliation': 'Onduo Professionals, PC, Newton, MA, United States.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Layne', 'Affiliation': 'Onduo, LLC, Newton, MA, United States.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'Dixon', 'Affiliation': 'Onduo, LLC, Newton, MA, United States.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Zisser', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}]",Journal of medical Internet research,['10.2196/21778']
2863,32856605,Asian race and risk of prostate cancer: Results from the REDUCE study.,"BACKGROUND


Global prostate cancer (PC) incidence rates are lower in Asian men than Caucasian men. Whether this is the result of less screening in Asian men remains to be determined. We examined whether Asian race was associated with PC diagnosis in the REDUCE study.
METHODS


REDUCE was a 4-year, multicenter, randomized trial of dutasteride vs. placebo for PC prevention among men who underwent PSA-independent biopsies at 2- and 4-years. Eligible men were aged 50-75 years, had PSA between 2.5-10 ng/mL, and a negative pre-study prostate biopsy. We tested the association between Asian and Caucasian race and PC diagnosis using logistic regression.
RESULTS


Of 8,122 men in REDUCE, 5,755 (71%) were Caucasian and 105 (1.8%) were Asian. Asians had lower body mass index (24.8 vs. 26.9 kg/m2, p<0.001), smaller prostate volume (35.0 vs. 43.5cc, p<0.001), and were less likely to have abnormal digital rectal exam (p=0.048), but were similar in baseline age, PSA, family history of PC, and smoking status compared to Caucasian men (all p≥0.164). Asian men were equally likely to receive any on-study biopsy compared to Caucasian men (p=0.634). After adjusting for potential confounders, Asian men were less likely to be diagnosed with PC during the 4-year study (OR=0.49, 95%CI 0.28-0.88, p=0.016), compared to Caucasian men.
CONCLUSIONS


In REDUCE, where all men underwent biopsies largely independent of PSA, Asian race was associated with lower PC diagnosis.
IMPACT


These findings suggest lower PC risk in Asian men may be due to biological, genetic, and/or lifestyle factors.",2020,Asian men were equally likely to receive any on-study biopsy compared to Caucasian men (p=0.634).,"['Eligible men were aged 50-75 years, had PSA between 2.5-10 ng/mL, and a negative pre-study prostate biopsy', 'Of 8,122 men in REDUCE, 5,755 (71%) were Caucasian and 105 (1.8%) were Asian', 'men who underwent PSA-independent biopsies at 2- and 4-years', 'Asian race and risk of prostate cancer', 'Asian men than Caucasian men', 'Asian men']",['dutasteride vs. placebo'],"['abnormal digital rectal exam', 'body mass index', 'smaller prostate volume']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0199900', 'cui_str': 'Rectal examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0426733', 'cui_str': 'Small prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0674668,Asian men were equally likely to receive any on-study biopsy compared to Caucasian men (p=0.634).,"[{'ForeName': 'Adriana C', 'Initials': 'AC', 'LastName': 'Vidal', 'Affiliation': 'Surgery, Cedars-Sinai Medical Center adriana.vidal@cshs.org.'}, {'ForeName': 'Taofik', 'Initials': 'T', 'LastName': 'Oyekunle', 'Affiliation': 'Duke Cancer Institute, Duke University School of Medicine.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Surgery, Cedars-Sinai Medical Center.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Freedland', 'Affiliation': 'Preventative Medicine, University of Southern California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Moreira', 'Affiliation': 'University of Chicago Medical Center.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Castro-Santamaria', 'Affiliation': 'R&D, GlaxoSmithKline.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Surgery, Cedars-Sinai Medical Center.'}, {'ForeName': 'Emma H', 'Initials': 'EH', 'LastName': 'Allott', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast.""}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-0646']
2864,32856619,"Effects of a Preoperative Carbohydrate-Rich Drink Before Ambulatory Surgery: A Randomized Controlled, Double-Blinded Study.","BACKGROUND The guidelines recommend oral carbohydrates up to 2 hr before elective surgery. The objective of this study was to explore the safety and feasibility of preoperative carbohydrate drink in patients undergoing ambulatory surgery. MATERIAL AND METHODS Patients undergoing ambulatory surgery under general anesthesia were enrolled. They were fasted from midnight and randomly assigned to a study group (200 mL of a carbohydrate beverage) or the control group (pure water) and received the assigned drink 2 hr before surgery. Bedside ultrasonography was performed to monitor gastric emptying at T₀ (before liquid intake), T₁ (5 min after intake), T₂ (1 hr after intake), and T₃ (2 hr after intake). Subjective feelings of thirst, hunger, anxiety, and fatigue were assessed 1 hr after liquid intake using the visual analogue scale (VAS). RESULTS In both groups, gastric antrum cross-sectional area, gastric content volume, and weight-corrected gastric content volume increased at T₁ and returned to baseline at T₃. These parameters were significantly higher in the study group at T₂ (6.28±1.38 vs. 4.98±0.78, 67.22±29.49 vs. 49.04±15.4, 1.10±0.51 vs. 0.85±0.37, P<0.05). Thirst and hunger VAS scores were reduced in both groups. The study group suffered significantly less hunger (28.44±10.41 vs. 36.03±14.42, P<0.05). Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels were similar in both groups at T₂. No gastric regurgitation or pulmonary aspiration was recorded. CONCLUSIONS Administration of 200 mL of oral carbohydrate beverage 2 hr before ambulatory surgery is safe, effective, and can be used for preoperative management of fasting patients.",2020,"Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels were similar in both groups at T₂. No gastric regurgitation or pulmonary aspiration was recorded.","['Patients undergoing ambulatory surgery under general anesthesia were enrolled', 'patients undergoing ambulatory surgery']","['Preoperative Carbohydrate-Rich Drink Before Ambulatory Surgery', 'preoperative carbohydrate drink', 'control group (pure water) and received the assigned drink 2 hr before surgery', 'Bedside ultrasonography']","['visual analogue scale (VAS', 'Thirst and hunger VAS scores', 'hunger ', 'Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels', 'Subjective feelings of thirst, hunger, anxiety, and fatigue', 'gastric antrum cross-sectional area, gastric content volume, and weight-corrected gastric content volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034193', 'cui_str': 'Pyloric antrum structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038352', 'cui_str': 'Gastric contents'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.061709,"Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels were similar in both groups at T₂. No gastric regurgitation or pulmonary aspiration was recorded.","[{'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Rui-Ke', 'Initials': 'RK', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Qu-Lian', 'Initials': 'QL', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922837']
2865,32856687,Dynamic Stress Responses and Real-Time Symptoms in Binge-Eating Disorder.,"BACKGROUND


Stress is a dynamic construct that predicts a range of health behaviors and conditions, including binge eating and excess weight. Thus far, there have been limited and inconsistent findings regarding stress responses in binge-eating disorder (BED) and insufficient consideration of temporal patterns of stress responses across the weight spectrum.
PURPOSE


The present study used ecological momentary assessment (EMA) to examine stress reactivity (i.e., the magnitude of the initial stress response), recovery (i.e., how long the stress response lasts before returning to baseline), and pileup (i.e., accumulation of repeated experiences of stressors and responses over time) as predictors of binge-eating symptoms (BES) and food craving in BED.
METHODS


Adults with BED (N = 115) completed a 7 day EMA protocol assessing stressful events, perceived stress, binge eating, and food craving prior to being randomized to a behavioral intervention.
RESULTS


Generalized estimating equations indicated that moments of greater stress pileup predicted greater subsequent BES (within-person effect). Participants with higher perceived stress and pileup reported greater overall BES and craving, and those with better recovery reported higher overall craving (between-person effects).
CONCLUSIONS


Findings highlight the importance of considering the dynamic nature of stress responses and, particularly, that the accumulation of stress over the day is an important trigger for BES.",2020,"Participants with higher perceived stress and pileup reported greater overall BES and craving, and those with better recovery reported higher overall craving (between-person effects).
","['Binge-Eating Disorder', 'Adults with BED (N = 115) completed a 7 day EMA protocol assessing stressful events, perceived stress, binge eating, and food craving prior to being randomized to a behavioral intervention']",[],"['overall craving', 'subsequent BES', 'Dynamic Stress Responses and Real-Time Symptoms', 'overall BES and craving', 'binge-eating symptoms (BES) and food craving in BED']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]",115.0,0.0566175,"Participants with higher perceived stress and pileup reported greater overall BES and craving, and those with better recovery reported higher overall craving (between-person effects).
","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schaefer', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, ND, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kobe', 'Initials': 'K', 'LastName': 'Critchley', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, ND, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, ND, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, ND, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, ND, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa061']
2866,32859183,Effects of exercise combined with whole body vibration in patients with patellofemoral pain syndrome: a randomised-controlled clinical trial.,"BACKGROUND


Patellofemoral pain is a prevalent condition in the general population, especially in women, and produces functional impairment in patients. Therapeutic exercise is considered an essential part of the conservative management. The use of vibration platforms may help improve strength and function and reduce pain in patients with knee disorders. The aim of this investigation was to determine the effects of adding whole body vibration (vertical, vibration frequency of 40 Hz, with an amplitude from 2 to 4 mm) to an exercise protocol for pain and disability in adults with patellofemoral pain.
METHODS


A randomised clinical trial was designed, where 50 subjects were randomly distributed into either an exercise group plus whole body vibration or a control group. Pain, knee function (self-reported questionnaire) and range of motion and lower limb functionality were assessed at baseline and at 4 weeks. The experimental group performed 12 supervised sessions of hip, knee and core strengthening exercises on a vibration platform 3 times per week during 4 weeks. The control group followed the same protocol but without vibration stimuli. Differences in outcome measures were explored using an analysis of the variance of 2 repeated measures. Effect sizes were estimated using Square Eta (η 2 ). Significant level was set al P < 0.05.
RESULTS


Statistically significant differences were found after intervention in favour of the experimental group in the between-groups comparison and in the interaction of the experimental group before and after treatment in terms of pain perception (P = 0.000; η 2  = 0.63) and function outcomes scores (P = 0.000; η 2  0.39 and 0.51 for lower limb functional scale and Kujala scores respectively).
CONCLUSION


A 4-week whole body vibration exercise programme reduces pain level intensity and improves lower limb functionality in patellofemoral pain patients and is more effective than exercise alone in improving pain and function in the short-term.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT04031248 ). This study was prospectively registered on the 24th July, 2019.",2020,"Statistically significant differences were found after intervention in favour of the experimental group in the between-groups comparison and in the interaction of the experimental group before and after treatment in terms of pain perception (P = 0.000; η 2  = 0.63) and function outcomes scores (P = 0.000; η 2  0.39 and 0.51 for lower limb functional scale and Kujala scores respectively).
","['adults with patellofemoral pain', 'patellofemoral pain patients', '50 subjects', 'patients with patellofemoral pain syndrome', 'patients with knee disorders']","['Therapeutic exercise', 'vibration platforms', 'exercise group plus whole body vibration or a control group', 'exercise combined with whole body vibration', '12 supervised sessions of hip, knee and core strengthening exercises', 'whole body vibration (vertical, vibration frequency of 40\u2009Hz, with an amplitude from 2 to 4\u2009mm) to an exercise protocol', 'exercise alone', 'body vibration exercise programme']","['function outcomes scores', 'pain and function', 'strength and function and reduce pain', 'pain and disability', 'pain level intensity', 'Pain, knee function (self-reported questionnaire) and range of motion and lower limb functionality', 'pain perception']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",50.0,0.0652986,"Statistically significant differences were found after intervention in favour of the experimental group in the between-groups comparison and in the interaction of the experimental group before and after treatment in terms of pain perception (P = 0.000; η 2  = 0.63) and function outcomes scores (P = 0.000; η 2  0.39 and 0.51 for lower limb functional scale and Kujala scores respectively).
","[{'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Yañez-Álvarez', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, 41009, Seville, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Bermúdez-Pulgarín', 'Affiliation': 'Department of Celular Biology, University of Seville, 41009, Seville, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Hernández-Sánchez', 'Affiliation': ""Physiotherapy Area, Traslational Research Centre of Physiotherapy, Miguel Hernandez University, Sant Joan d'Alacant, 03550, Alicante, Spain. sehesa@goumh.umh.es.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Albornoz-Cabello', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, 41009, Seville, Spain.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03599-2']
2867,32859235,Rifampin combination therapy in staphylococcal prosthetic joint infections: a randomized controlled trial.,"BACKGROUND


The evidence supporting rifampin combination therapy in prosthetic joint infections (PJI) is limited due to the lack of controlled studies. The aim of this study is to evaluate the effect of adding rifampin to conventional antimicrobial therapy in early staphylococcal PJIs treated with debridement and retention of the implant (DAIR).
METHODS


In this multicenter randomized controlled trial, 99 patients with PJI after hip and knee arthroplasties were enrolled. They were randomly assigned to receive rifampin or not in addition to standard antimicrobial treatment with cloxacillin or vancomycin in case of methicillin resistance. The primary endpoint was no signs of infection after 2 years of follow-up.
RESULTS


Forty-eight patients were included in the final analyses. There were no differences in patient characteristics or comorbidities between the two groups. There was no significant difference in remission rate between the rifampin combination group (17 of 23 (74%)) and the monotherapy group (18 of 25 (72%), relative risk 1.03, 95% confidence interval 0.73 to 1.45, p = 0.88).
CONCLUSION


This trial has not proven a statistically significant advantage by adding rifampin to standard antibiotic treatment in acute staphylococcal PJIs.
TRIAL REGISTRATION


The Regional Ethics Committee and the Norwegian Medicines Agency approved the study (EudraCT 2005-005494-29), and the study was registered at ClinicalTrials.gov at Jan 18, 2007 ( NCT00423982 ).",2020,"There was no significant difference in remission rate between the rifampin combination group (17 of 23 (74%)) and the monotherapy group (18 of 25 (72%), relative risk 1.03, 95% confidence interval 0.73 to 1.45, p = 0.88).
","['99 patients with PJI after hip and knee arthroplasties were enrolled', 'Forty-eight patients were included in the final analyses', 'prosthetic joint infections (PJI', 'staphylococcal prosthetic joint infections']","['rifampin to conventional antimicrobial therapy', 'Rifampin combination therapy', 'cloxacillin or vancomycin', 'rifampin combination therapy', 'rifampin']","['patient characteristics or comorbidities', 'signs of infection after 2\u2009years of follow-up', 'remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",99.0,0.453535,"There was no significant difference in remission rate between the rifampin combination group (17 of 23 (74%)) and the monotherapy group (18 of 25 (72%), relative risk 1.03, 95% confidence interval 0.73 to 1.45, p = 0.88).
","[{'ForeName': 'Øystein Espeland', 'Initials': 'ØE', 'LastName': 'Karlsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway. oekarl00@hotmail.com.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Borgen', 'Affiliation': 'Department of Orthopaedic Surgery, Martina Hansen Hospital, Bærum, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bragnes', 'Affiliation': 'Department of Orthopaedic Surgery, Vestre Viken HF, Drammen, Norway.'}, {'ForeName': 'Wender', 'Initials': 'W', 'LastName': 'Figved', 'Affiliation': 'Department of Orthopaedic Surgery, Bærum Hospital, Bærum, Norway.'}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Grøgaard', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rydinge', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Sandberg', 'Affiliation': 'Department of Orthopaedic Surgery, Sykehuset Innlandet HF, Lillehammer, Norway.'}, {'ForeName': 'Finnur', 'Initials': 'F', 'LastName': 'Snorrason', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Wangen', 'Affiliation': 'Department of Orthopaedic Surgery, Sykehuset Innlandet HF, Elverum, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Witsøe', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Westberg', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01877-2']
2868,32859250,Evaluation of the efficacy and safety of the use of acupuncture for the adjuvant treatment of patients with post-stroke cognitive impairment: protocol for a randomized controlled trial.,"BACKGROUND


Post-stroke cognitive impairment (PSCI) is a series of syndromes that meet the diagnostic criteria for cognitive impairment that appear after a stroke. The treatment of PSCI with oral drugs alone is not ideal and has obvious side effects. Therefore, complementary and alternative treatments are needed for patients with insufficient or significant side effects of oral medications. Therefore, we will evaluate the clinical effectiveness and safety of acupuncture in the treatment of PSCI.
METHODS/DESIGN


In this study, patients will be randomly divided into two groups. Intervention group: acupuncture combined with oral medication.
CONTROL GROUP


Western medicine treatment plan. All participants will continue to receive conventional drug treatment. The selection of outcomes will be evaluated by Mini Mental State Examination Scale (MMSE) at week 12. The scale will be conducted by two well-trained reviewers who will conduct joint MMSE inspections on participants. The test time will be selected 3 days before treatment and once 4 weeks after treatment. After the MMSE test, the two raters scored independently, and the average of the two was used as the final score.
DISCUSSION


This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with PSCI.
TRIAL REGISTRATION


ClinicalTrials.gov ChiCTR2000029926. Registered on 17 February 2020 http://www.chictr.org.cn/showproj.aspx?proj=49356.",2020,"BACKGROUND


Post-stroke cognitive impairment (PSCI) is a series of syndromes that meet the diagnostic criteria for cognitive impairment that appear after a stroke.","['patients with post-stroke cognitive impairment', 'patients with PSCI']","['acupuncture', 'acupuncture combined with oral medication']","['Mini Mental State Examination Scale (MMSE', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.155834,"BACKGROUND


Post-stroke cognitive impairment (PSCI) is a series of syndromes that meet the diagnostic criteria for cognitive impairment that appear after a stroke.","[{'ForeName': 'Ruijia', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jisheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Cao', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'The Department of Acupuncture, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijng, 100700, China. hydud2020@163.com.'}]",Trials,['10.1186/s13063-020-04656-w']
2869,32859272,"Interpersonal reactivity index adaptation among expectant seroconcordant couples with HIV in Zambézia Province, Mozambique.","BACKGROUND


The ability to understand another's emotions and act appropriately, empathy, is an important mediator of relationship function and health intervention fidelity. We adapted the Interpersonal Reactivity Index (IRI) - an empathy scale - among seroconcordant expectant couples with HIV in the Homens para Saúde Mais (HoPS+) trial - a cluster randomized controlled trial assessing couple-based versus individual treatment on viral suppression - in Zambézia Province, Mozambique.
METHODS


Using baseline data from 1332 HoPS+ trial participants (666 couples), an exploratory factor analysis assessed culturally relevant questions from the IRI. Because empathy is interdependent among couples, we validated the results of the exploratory factor analysis using a dyadic confirmatory factor analysis (CFA) with dyadic measurement invariance testing. Finally, we assessed the relationship between scores on our final scale and basic demographic characteristics (sex, age, education, and depression) using t-tests.
RESULTS


We found two subscales: 1) a seven-item cognitive empathy subscale (Cronbach's alpha 0.78) and 2) a six-item affective empathy subscale (Cronbach's alpha 0.73). The dyadic CFA found acceptable model fit and metric invariance across partners (Comparative Fit Index (CFI) = 0.914, Tucker Lewis Index = 0.904, Root Mean Squared Error of Approximation = 0.056, ΔCFI = 0.011). We observed higher cognitive (p: 0.012) and affective (p: 0.049) empathy among males and higher cognitive (p: 0.031) and affective (p: 0.030) empathy among younger participants. More educated participants had higher affective empathy (p: 0.017) and depressed participants had higher cognitive empathy (p: < 0.001). This two-subscale, 13-item version of the IRI measures cognitive and affective empathy in HoPS+ trial participants and adults while accounting for the interdependent nature of empathy within partner dyads.
CONCLUSIONS


This scale will allow us to assess the interplay between empathy and other psychometric constructs (stigma, social support, etc.) in the HoPS+ trial and how each relates to retention in HIV, adherence to treatment, and prevention of maternal to child HIV transmission. Furthermore, this scale can be adapted for other sub-Saharan African populations, which will allow researchers to better assess HIV-related intervention efficacy.
TRIAL REGISTRATION


This study is within the context of the HoPS+ trial, registered at ClinicalTrials.gov as number NCT03149237 . Registered May 11, 2017.",2020,More educated participants had higher affective empathy (p: 0.017) and depressed participants had higher cognitive empathy (p: < 0.001).,"['HoPS+ trial participants and adults while accounting for the interdependent nature of empathy within partner dyads', 'seroconcordant expectant couples with HIV in the Homens para Saúde Mais (HoPS+) trial ', 'expectant seroconcordant couples with HIV in Zambézia Province, Mozambique', '1332 HoPS+ trial participants (666 couples']",['Interpersonal Reactivity Index (IRI) - an empathy scale '],"['Interpersonal reactivity index adaptation', 'higher affective empathy', ""seven-item cognitive empathy subscale (Cronbach's alpha 0.78) and 2) a six-item affective empathy subscale"", 'final scale and basic demographic characteristics (sex, age, education, and depression', 'cognitive empathy']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4517480', 'cui_str': '0.78'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.094547,More educated participants had higher affective empathy (p: 0.017) and depressed participants had higher cognitive empathy (p: < 0.001).,"[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Sack', 'Affiliation': 'Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, 2525 West End Ave, Suite 750, Nashville, TN, 37203, USA. daniel.e.sack@vanderbilt.edu.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Frisby', 'Affiliation': 'School of Education, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Diemer', 'Affiliation': 'School of Education, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'De Schacht', 'Affiliation': 'Friends in Global Health, Maputo, Mozambique.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Graves', 'Affiliation': 'Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, 2525 West End Ave, Suite 750, Nashville, TN, 37203, USA.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Kipp', 'Affiliation': 'Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, 2525 West End Ave, Suite 750, Nashville, TN, 37203, USA.'}, {'ForeName': 'Almiro', 'Initials': 'A', 'LastName': 'Emílio', 'Affiliation': 'Friends in Global Health, Quelimane, Mozambique.'}, {'ForeName': 'Ariano', 'Initials': 'A', 'LastName': 'Matino', 'Affiliation': 'Friends in Global Health, Quelimane, Mozambique.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Barreto', 'Affiliation': 'Friends in Global Health, Quelimane, Mozambique.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Van Rompaey', 'Affiliation': 'Friends in Global Health, Maputo, Mozambique.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Wallston', 'Affiliation': 'Vanderbilt Institute for Medicine and Public Health, Nashville, TN, USA.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Audet', 'Affiliation': 'Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, 2525 West End Ave, Suite 750, Nashville, TN, 37203, USA.'}]",BMC psychology,['10.1186/s40359-020-00442-0']
2870,32859328,The clinical effects of a carbohydrate-reduced high-protein diet on glycaemic variability in metformin-treated patients with type 2 diabetes mellitus: A randomised controlled study.,"BACKGROUND & AIMS


High glycaemic variability (GV) is associated with late complications in type 2 diabetes (T2D). We hypothesised that a carbohydrate-reduced high-protein (CRHP) diet would reduce GV acutely in patients with T2D compared with a conventional diabetes (CD) diet.
METHODS


In this controlled, randomised crossover study, 16 patients with metformin-treated T2D (median (IQR) age: 64.0 (58.8-68.0) years; HbA 1c : 47 (43-57) mmol/mol; duration of T2D: 5.5 (2.8-10.3) years) were assigned to an energy-matched CRHP diet and CD diet (31E%/54E% carbohydrate, 29E%/16E% protein and 40E%/30E% fat, respectively) for two separate 48-h intervention periods. Interstitial continuous glucose monitoring (CGM) was performed to assess accepted measures of glycaemic variability, i.e. standard deviation (SD) around the sensor glucose level; coefficient of variation in percent (CV); mean amplitude of glucose excursions (MAGE); continuous overlapping net glycaemic action (CONGA 1 , CONGA 4 ) of observations 1 and 4 h apart; and mean absolute glucose (MAG) change.
RESULTS


All indices of glycaemic variability (mean ± SD) were significantly reduced during CRHP diet compared with CD diet; including SD (1.0 ± 0.3 (CRHP) vs 1.6 ± 0.5 mmol/L (CD)), CV (12.3 ± 3.8 vs 19.3 ± 5.5%), MAGE (2.3 ± 0.9 vs 4.2 ± 1.3 mmol/L), CONGA 1  (0.8 ± 0.3 vs 1.5 ± 0.4 mmol/L), CONGA 4  (1.4 ± 0.5 vs 2.5 ± 0.8 mmol/L), and MAG change (0.9 ± 0.3 vs 1.4 ± 0.4 mmol/L/h) (p < 0.001 for all). Compared with the CD diet, the CRHP diet improved the diurnal glucose profile by reducing 24-h mean sensor glucose (7.7 ± 1.6 vs 8.6 ± 2.0 mmol/L).
CONCLUSIONS


In T2D patients treated with diet and metformin, two days of iso-energetic replacement of dietary carbohydrates by protein and fat reduced all indices of glycaemic variability by 36%-45% when compared with a conventional diabetes diet. These data may support reduction of carbohydrates as dietary advice for T2D patients. CLINICALTRIALS.
GOV IDENTIFIER


NCT02472951.",2020,"All indices of glycaemic variability (mean ± SD) were significantly reduced during CRHP diet compared with CD diet; including SD (1.0 ± 0.3 (CRHP) vs 1.6 ± 0.5 mmol/L (CD)), CV (12.3 ± 3.8 vs 19.3 ± 5.5%), MAGE (2.3 ± 0.9 vs 4.2 ± 1.3 mmol/L), CONGA 1  (0.8 ± 0.3 vs 1.5 ± ","['16 patients with metformin-treated T2D (median (IQR) age: 64.0 (58.8-68.0) years; HbA 1c : 47 (43-57) mmol/mol; duration of T2D: 5.5 (2.8-10.3) years', 'treated patients with type 2 diabetes mellitus', 'T2D patients', 'patients with T2D compared with a conventional diabetes (CD) diet']","['carbohydrate-reduced high-protein (CRHP) diet', 'energy-matched CRHP diet and CD diet (31E%/54E% carbohydrate, 29E%/16E% protein and 40E%/30E% fat, respectively) for two separate 48-h intervention periods', 'metformin', 'diet and metformin', 'Interstitial continuous glucose monitoring (CGM', 'carbohydrate-reduced high-protein diet', 'CRHP diet']","['MAG change', 'glycaemic variability, i.e. standard deviation (SD) around the sensor glucose level; coefficient of variation in percent (CV); mean amplitude of glucose excursions (MAGE); continuous overlapping net glycaemic action (CONGA 1 , CONGA 4 ) of observations 1 and 4\xa0h apart; and mean absolute glucose (MAG) change', 'glycaemic variability', 'diurnal glucose profile', 'glycaemic variability (mean\xa0±\xa0SD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",16.0,0.0216868,"All indices of glycaemic variability (mean ± SD) were significantly reduced during CRHP diet compared with CD diet; including SD (1.0 ± 0.3 (CRHP) vs 1.6 ± 0.5 mmol/L (CD)), CV (12.3 ± 3.8 vs 19.3 ± 5.5%), MAGE (2.3 ± 0.9 vs 4.2 ± 1.3 mmol/L), CONGA 1  (0.8 ± 0.3 vs 1.5 ± ","[{'ForeName': 'Mads N', 'Initials': 'MN', 'LastName': 'Thomsen', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark. Electronic address: mads.norvin.thomsen@regionh.dk.'}, {'ForeName': 'Mads J', 'Initials': 'MJ', 'LastName': 'Skytte', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Dept. of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Deacon', 'Affiliation': 'Endocrinology Research Section, Dept. of Biomedical Sciences, University of Copenhagen, Denmark; Section for Translational Physiology, NNF Center for Basic Metabolic Research, University of Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Endocrinology Research Section, Dept. of Biomedical Sciences, University of Copenhagen, Denmark; Section for Translational Physiology, NNF Center for Basic Metabolic Research, University of Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital Amager Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark; Dept. of Internal Medicine, Copenhagen University Hospital Amager Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Amirsalar', 'Initials': 'A', 'LastName': 'Samkani', 'Affiliation': 'Dept. of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2020.07.002']
2871,32859329,"The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial.","BACKGROUND


The aim of this study was to evaluate the effects of supplementation with 10 9  spores of Bacillus coagulans (GBI-30) plus inulin in patients with non-alcoholic fatty liver disease (NAFLD).
METHODS


In a randomized, double-blind, placebo-controlled clinical trial, fifty three patients with NAFLD were randomly assigned to receive either a synbiotic or a placebo capsule for 12 weeks. The primary outcome was reduction in steatosis score in Fibroscan exam.
RESULTS


At the end of study, serum alanine aminotransferase and γ glutamine transaminase decreased significantly more in synbiotic group compared to placebo group (p = 0.001, and p = 0.004, respectively). Synbiotic supplementation significantly reduced serum tumor necrosis factor-α (p = 0.03) and nuclear factor-κB activity (p = 0.04). Moreover, hepatic steatosis reduced significantly more in synbiotic group compared to placebo group (p < 0.001).
CONCLUSION


Our results indicate that 12 weeks supplementation with B. coagulans plus inulin is beneficial for treatment of NAFLD and its related inflammation without any significant effects on related cardiovascular risk factors.
CLINICAL TRIALS


This trial was registered at irct.ir with number of IRCT20100524004010N23.",2020,"At the end of study, serum alanine aminotransferase and γ glutamine transaminase decreased significantly more in synbiotic group compared to placebo group (p = 0.001, and p = 0.004, respectively).","['fifty three patients with NAFLD', 'patients with non-alcoholic fatty liver disease (NAFLD', 'patients with non-alcoholic fatty liver disease']","['Bacillus coagulans supplementation', 'synbiotic or a placebo capsule', 'Synbiotic supplementation', 'supplementation with 10 9  spores of Bacillus coagulans (GBI-30) plus inulin', 'placebo']","['hepatic steatosis', 'reduction in steatosis score in Fibroscan exam', 'nuclear factor-κB activity', 'serum tumor necrosis factor-α ', 'serum alanine aminotransferase and γ glutamine transaminase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0314931', 'cui_str': 'Bacteroides coagulans'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0038027', 'cui_str': 'Spores'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0061488', 'cui_str': 'Glutamine-pyruvate aminotransferase'}]",53.0,0.786538,"At the end of study, serum alanine aminotransferase and γ glutamine transaminase decreased significantly more in synbiotic group compared to placebo group (p = 0.001, and p = 0.004, respectively).","[{'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Abhari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeede', 'Initials': 'S', 'LastName': 'Saadati', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Department of Food Technology, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahabeddin', 'Initials': 'S', 'LastName': 'Abhari', 'Affiliation': 'Amol Faculty of Paramedical Sciences, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyyed Moayyed', 'Initials': 'SM', 'LastName': 'Alavian', 'Affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: a_hekmat2000@yahoo.com.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2020.06.020']
2872,32859392,Heparin-bonded versus standard polytetrafluoroethylene arteriovenous grafts: A Bayesian perspective on a randomized controlled trial for comparative effectiveness.,"BACKGROUND


Heparin-bonded polytetrafluoroethylene grafts were marketed to improve hemodialysis access outcomes but are twice the cost of standard polytetrafluoroethylene. We launched a randomized trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for hemodialysis access to compare patency. Since the trial began, additional studies were published with heterogeneous findings. We performed an interim analysis by Bayesian methods using prior probability from meta-analysis of existing literature.
METHODS


NCT01601873 is a randomized, blinded trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for dialysis access at 5 sites. Planned sample size was 200 with 1-year primary patency as the primary endpoint. At interim analysis (50% of sample size at 1 year), we also performed a meta-analysis for 1-year primary patency with a random effects model to compute summary rate ratio and standard-error estimates. Meta-analysis estimates formed a prior probability for a Bayesian Cox regression model, and trial data were reanalyzed to develop posterior probability of heparin-bonded polytetrafluoroethylene effectiveness at our hypothesized effect size. Futility analysis was conducted using posterior probability estimates.
RESULTS


One hundred and five patients were enrolled at the time of interim analysis. One-year primary patency was 34.9% in the heparin-bonded-polytetrafluoroethylene group vs 32.7% in the standard-polytetrafluoroethylene group (P = .884). Summary rate ratio from the meta-analysis (1,209 patients) was 0.87 favoring heparin-bonded polytetrafluoroethylene (P = .33). Posterior hazard ratio from Cox regression was 0.90 (credible interval 0.70-1.13) favoring heparin-bonded polytetrafluoroethylene, which was not significant. Bayesian posterior probability of the a priori hypothesized 20% better patency with heparin-bonded polytetrafluoroethylene was 24%. Sample size to detect superiority with the small observed effect size would require about 3,800 subjects.
CONCLUSION


Current evidence does not demonstrate sufficiently large benefit of heparin-bonded polytetrafluoroethylene over standard polytetrafluoroethylene for dialysis access to justify higher cost. Given similar 1-year patency rates, a conclusive finding of superiority was judged to be infeasible, and the trial was stopped for futility.",2020,One-year primary patency was 34.9% in the heparin-bonded-polytetrafluoroethylene group vs 32.7% in the standard-polytetrafluoroethylene group (P = .884).,['One hundred and five patients were enrolled at the time of interim analysis'],"['heparin-bonded polytetrafluoroethylene', 'Heparin-bonded versus standard polytetrafluoroethylene arteriovenous grafts', 'Heparin-bonded polytetrafluoroethylene grafts', 'heparin-bonded-polytetrafluoroethylene', 'heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene']","['Posterior hazard ratio from Cox regression', 'Summary rate ratio', '1-year patency rates']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",105.0,0.231619,One-year primary patency was 34.9% in the heparin-bonded-polytetrafluoroethylene group vs 32.7% in the standard-polytetrafluoroethylene group (P = .884).,"[{'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, TX; Department of Surgery, San Antonio Military Medical Center, Fort Sam Houston, TX.'}, {'ForeName': 'Harleen K', 'Initials': 'HK', 'LastName': 'Sandhu', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, TX.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Perlick', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, TX.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Wong', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Smith', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Ochsner Medical Center, New Orleans, LA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smeds', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'Naveed U', 'Initials': 'NU', 'LastName': 'Saqib', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, TX.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Martin', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, TX.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, TX.'}, {'ForeName': 'Kristofer M', 'Initials': 'KM', 'LastName': 'Charlton-Ouw', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, TX; HCA Houston Healthcare and the University of Houston College of Medicine, TX. Electronic address: Kristofer.CharltonOuw@uth.tmc.edu.'}]",Surgery,['10.1016/j.surg.2020.07.013']
2873,32859432,Prognostic value of a new staging system based on the retrieved number and metastatic rate of LNs in gastric cancer with ≤15 retrieved LNs.,"OBJECTIVE


To investigate a reasonable lymph node (N) staging system for gastric cancer patients with ≤15 retrieved lymph nodes (LNs).
METHODS


The clinicopathological and follow-up data of patients with ≤15 LNs were obtained from the US Surveillance, Epidemiology, and End Results (SEER) database to analyze the impact of the number of retrieved LNs and metastatic status on the prognosis. In addition, external validation was achieved with data from two medical centers in China.
RESULTS


A total of 18,139 gastric cancer patients with 1-15 retrieved LNs from the SEER database were enrolled and randomly divided into the training group and the internal validation group. A new LN staging system, mNr staging (mNr0-4; 5 stages), was established according to the number of retrieved LNs and the metastatic rate. Compared with the TNM and TNrM staging systems (established by Wang J; misclassification rates of 50.4% and 62.5%, respectively), the mTNrM staging system had a lower misclassification rate (23.4%). Furthermore, there was a significant difference in the 5-year overall survival (OS) rate between the mTNrM staging subgroups (p < 0.05); however, no significant difference was found in the 5-year OS rate of partial adjacent stages in the TNM (8th edition) and TNrM (p > 0.05) staging systems. Similar results were obtained in the external validation cohort.
CONCLUSION


mNr and mTNrM staging systems can efficiently distinguish a survival difference in patients who undergo gastrectomy with ≤15 retrieved LNs, with more accurate predictions of the 5-year OS rate of patients compared with the TNM and TNrM staging systems.",2020,"Compared with the TNM and TNrM staging systems (established by Wang J; misclassification rates of 50.4% and 62.5%, respectively), the mTNrM staging system had a lower misclassification rate (23.4%).","['18,139 gastric cancer patients with 1-15 retrieved LNs from the SEER database', 'gastric cancer patients with ≤15 retrieved lymph nodes (LNs', 'patients with ≤15 LNs', 'gastric cancer with ≤15 retrieved LNs']",[],"['5-year OS rate', 'misclassification rate', '5-year overall survival (OS) rate', '5-year OS rate of partial adjacent stages']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",18139.0,0.0316253,"Compared with the TNM and TNrM staging systems (established by Wang J; misclassification rates of 50.4% and 62.5%, respectively), the mTNrM staging system had a lower misclassification rate (23.4%).","[{'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Caner Center, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Caner Center, Guangzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Caner Center, Guangzhou, China. Electronic address: zhouzhw@sysucc.org.cn.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China. Electronic address: hcmlr2002@163.com.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China. Electronic address: wwkzch@163.com.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.07.001']
2874,32859561,Small airways' function in Obstructive Sleep Apnea-Hypopnea Syndrome.,"INTRODUCTION AND OBJECTIVES


Most of the studies of the pathophysiology of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) focus on the collapsibility and obstruction of the upper airways. The aim of our study was the investigation of small airways' function in patients with OSAHS.
MATERIALS AND METHODS


We studied 23 patients (mean age, 51.6 years) diagnosed with mild to severe OSAHS, without comorbidities and 8 controls (mean age, 45.9 years). All subjects underwent full polysomnography sleep study; spirometry and maximum flow/volume curves while breathing room air and a mixture of 80%He-20%O 2 . The volume of equal flows (VisoV⋅) of the two curves and the difference of flows at 50% of FVC (ΔV˙max 50 ) were calculated, as indicates of small airways' function.
RESULTS


The results showed that VisoV⋅ was significantly increased in patients with OSAHS compared with controls (18.79±9.39 vs. 4.72±4.68, p=0.004). No statistically significantly difference was found in ΔV˙ max50%  (p=0.551); or the maximum Expiratory flow at 25-75% of FVC (p=0.067) and the maximum expiratory flow at 50% of FVC (p=0.174) breathing air.
CONCLUSIONS


We conclude that at the time of the diagnosis of OSAHS, the function of the small airways is affected. This could be due to breathing at low lung volumes and the cyclic closure/opening of the small airways and may affect the natural history of OSAHS. The findings could lead to new therapeutic implications, targeting directly the small airways.",2020,"No statistically significantly difference was found in ΔV˙ max50%  (p=0.551); or the maximum Expiratory flow at 25-75% of FVC (p=0.067) and the maximum expiratory flow at 50% of FVC (p=0.174) breathing air.
","['We studied 23 patients (mean age, 51.6 years) diagnosed with mild to severe OSAHS, without comorbidities and 8 controls (mean age, 45.9 years', 'Obstructive Sleep Apnea-Hypopnea Syndrome', 'patients with OSAHS']",['full polysomnography sleep study; spirometry and maximum flow/volume curves while breathing room air and a mixture of 80%He-20%O 2 '],"['volume of equal flows (VisoV⋅', 'maximum expiratory flow', 'maximum Expiratory flow', 'VisoV⋅']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]",23.0,0.0285587,"No statistically significantly difference was found in ΔV˙ max50%  (p=0.551); or the maximum Expiratory flow at 25-75% of FVC (p=0.067) and the maximum expiratory flow at 50% of FVC (p=0.174) breathing air.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Giannadaki', 'Affiliation': 'Department of Thoracic Medicine, University Hospital of Heraklion, Heraklion, Crete, Greece; Sleep Disorders Center, Medical School, University of Crete, Heraklion, Crete, Greece.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schiza', 'Affiliation': 'Department of Thoracic Medicine, University Hospital of Heraklion, Heraklion, Crete, Greece; Sleep Disorders Center, Medical School, University of Crete, Heraklion, Crete, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vavougios', 'Affiliation': 'Department of Neurology, Athens Naval Hospital and Scientific Research Associate, University of Thessaly, Larisa, Greece.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ladopoulos', 'Affiliation': 'Foundation for Research and Technology Hellas, Institute of Electronic Structure and Laser, Heraklion, Crete, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tzanakis', 'Affiliation': 'Department of Thoracic Medicine, University Hospital of Heraklion, Heraklion, Crete, Greece; Sleep Disorders Center, Medical School, University of Crete, Heraklion, Crete, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Siafakas', 'Affiliation': 'Department of Thoracic Medicine, University Hospital of Heraklion, Heraklion, Crete, Greece; Sleep Disorders Center, Medical School, University of Crete, Heraklion, Crete, Greece. Electronic address: siafak@med.uoc.gr.'}]",Pulmonology,['10.1016/j.pulmoe.2020.05.006']
2875,32859607,Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Control Trial.,"OBJECTIVE


The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control.
RESEARCH DESIGN AND METHODS


In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9-10.0 mmol/L [70-180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems.
RESULTS


Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM ( n  = 30) or isCGM ( n  = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively;  P  = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively;  P  = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9-10 mmol/L [70-180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively;  P  = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively;  P  = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm.
CONCLUSIONS


rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.",2020,"CONCLUSIONS


rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.","['adults with T1D with normal hypoglycemia awareness', 'adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase', 'Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1', 'Type 1 Diabetes']","['isCGM', 'rtCGM', 'real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM', 'isCGM group wore an additional masked Enlite sensor (iPro2', 'Flash Glucose Monitoring']","['Hypoglycemia differences', 'time in hypoglycemia', 'Percentage of time in hypoglycemia', 'hypoglycemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",60.0,0.0495856,"CONCLUSIONS


rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.","[{'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Hásková', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Radovnická', 'Affiliation': 'Masaryk Hospital, Ústí nad Labem, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Petruželková', 'Affiliation': 'Department of Paediatrics, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Parkin', 'Affiliation': 'CGParkin Communications, Inc., Henderson, NV.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grunberger', 'Affiliation': 'Grunberger Diabetes Institute, Bloomfield Hills, MI.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Horová', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vendula', 'Initials': 'V', 'LastName': 'Navrátilová', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ondřej', 'Initials': 'O', 'LastName': 'Kádě', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Matoulek', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prázný', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Šoupal', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic jan.soupal@seznam.cz.'}]",Diabetes care,['10.2337/dc20-0112']
2876,32859608,"Cardiovascular effects of biological versus conventional synthetic disease-modifying antirheumatic drug therapy in treatment-naïve, early rheumatoid arthritis.","OBJECTIVES


To determine whether patients with early rheumatoid arthritis (ERA) have cardiovascular disease (CVD) that is modifiable with disease-modifying antirheumatic drug (DMARD) therapy, comparing first-line etanercept (ETN) + methotrexate (MTX) with MTX strategy.
METHODS


Patients from a phase IV ERA trial randomised to ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR) at baseline, years 1 and 2. Thirty matched controls underwent CMR. Primary outcome measure was aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA. Secondary analyses between and within ERA groups performed. Additional outcome measures included left ventricular (LV) mass and myocardial extracellular volume (ECV).
RESULTS


Eighty-one patients recruited. In ERA versus controls, respectively, baseline (geometric mean, 95% CI) AD was significantly lower (3.0×10 -3  mm Hg -1  (2.7-3.3) vs 4.4×10 -3  mm Hg -1  (3.7-5.2), p<0.001); LV mass significantly lower (78.2 g (74.0-82.7), n=81 vs 92.9 g (84.8-101.7), n=30, p<0.01); and ECV increased (27.1% (26.4-27.9), n=78 vs 24.9% (23.8-26.1), n=30, p<0.01). Across all patients, AD improved significantly from baseline to year 1 (3.0×10 -3  mm Hg -1  (2.7-3.4) to 3.6×10 -3  mm Hg -1  (3.1-4.1), respectively, p<0.01), maintained at year 2. The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
CONCLUSION


We report the first evidence of vascular and myocardial abnormalities in an ERA randomised controlled trial cohort and show improvement with DMARD therapy. The type of DMARD (first-line tumour necrosis factor-inhibitors or MTX) and clinical response to therapy did not affect CVD markers.
TRIAL REGISTRATION NUMBER


ISRCTN: ISRCTN89222125; ClinicalTrials.gov: NCT01295151.",2020,"The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
","['Patients from a phase IV ERA trial randomised to', 'patients with early rheumatoid arthritis (ERA', 'Eighty-one patients recruited']","['DMARD therapy', 'CMR', 'etanercept (ETN) + methotrexate (MTX) with MTX strategy', 'biological versus conventional synthetic disease-modifying antirheumatic drug therapy', 'ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR']","['ECV', 'LV mass', 'disease activity state (Disease Activity Score', 'left ventricular (LV) mass and myocardial extracellular volume (ECV', 'aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517884', 'cui_str': '81'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",81.0,0.40753,"The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Plein', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Bara', 'Initials': 'B', 'LastName': 'Erhayiem', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Fent', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Horton', 'Affiliation': 'Central Lancashire Moving Well Service, Lancashire and South Cumbria NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Raluca Bianca', 'Initials': 'RB', 'LastName': 'Dumitru', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth Ma', 'Initials': 'EM', 'LastName': 'Hensor', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baxter', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Pavitt', 'Affiliation': 'Dental Translational and Clinical Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Maya H', 'Initials': 'MH', 'LastName': 'Buch', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK maya.buch@manchester.ac.uk.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217653']
2877,32859615,Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial.,"Observational studies report that physical activity and metformin are associated with improved clinical outcome in patients with cancer. Inflammation is one biological mechanism hypothesized to mediate these associations. In this phase II, multi-center, 2x2 factorial trial, 139 patients with breast and colorectal cancer who completed standard therapy were randomized to one of four treatment groups for 12 weeks: exercise alone, metformin alone, exercise and metformin, or control. Inflammation outcomes included high sensitivity C-reactive protein (hs-CRP), soluble tumor necrosis factor alpha receptor two (sTNF-αR2), and interleukin 6 (IL-6). The primary modeling strategy evaluated the trial product estimand that was quantified using a generalized linear mixed model. Compared with control, exercise alone reduced hs-CRP: -30.2% (95% CI: -50.3, -1.0) and IL-6: -30.9% (95% CI: -47.3, -9.5); but did not change sTNF-αR2: 1.0% (95% CI: -10.4, 13.9). Compared with control, metformin alone did not change hs-CRP: -13.9% (95% CI: -40.0, 23.4), sTNF-aR2: -10.4% (95% CI: -21.3, 2.0), or IL-6: -22.9% (95% CI: -42.3, 2.0). Compared with control, exercise and metformin reduced sTNF-αR2: -13.1% (95% CI: -22.9, -1.0) and IL-6: -38.7% (95% CI: -52.3, -18.9); but did not change hs-CRP: -20.5% (95% CI: -44.0, 12.7). The combination of exercise and metformin was not synergistic for hs-CRP, sTNF-αR2, or IL-6. In survivors of breast and colorectal cancer with low baseline physical activity and without type 2 diabetes, exercise and metformin reduced measures of inflammation that are associated with cancer recurrence and mortality.",2020,"Compared with control, exercise alone reduced hs-CRP: -30.2% (95% CI: -50.3, -1.0) and IL-6: -30.9% (95% CI: -47.3, -9.5); but did not change sTNF-αR2: 1.0% (95% CI: -10.4, 13.9).","['Breast and Colorectal Cancer', '139 patients with breast and colorectal cancer who completed standard therapy', 'patients with cancer']","['Exercise or Metformin', 'exercise alone, metformin alone, exercise and metformin, or control', 'metformin', 'exercise and metformin']","['high sensitivity C-reactive protein (hs-CRP), soluble tumor necrosis factor alpha receptor two (sTNF-αR2), and interleukin 6 (IL-6', 'change hs-CRP', 'cancer recurrence and mortality', 'sTNF-αR2']","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",139.0,0.146342,"Compared with control, exercise alone reduced hs-CRP: -30.2% (95% CI: -50.3, -1.0) and IL-6: -30.9% (95% CI: -47.3, -9.5); but did not change sTNF-αR2: 1.0% (95% CI: -10.4, 13.9).","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Population and Public Health Sciences, Pennington Biomedical Research Center Justin.Brown@pbrc.edu.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ligibel', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health.'}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': 'Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Campbell', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pollak', 'Affiliation': 'Experimental Medicine and Oncology, McGill University.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sorrentino', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, Yale Cancer Center.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Chronic Disease and Epidemiology, Yale School of Public Health.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Division of Breast Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Abrams', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Medical Oncology, Yale Cancer Center, Yale School of Medicine.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Douglas', 'Affiliation': 'Cardiology, Duke Medical Center.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Nutrition and Epidemiology, Harvard School of Public Health.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0188']
2878,32859731,Comparison of the efficacy of ketamine- propofol versus sodium thiopental-fentanyl in sedation: a randomised clinical trial.,"BACKGROUND


Many sedative regimens have been studied with controversial efficiencies. This study tried to assess the desirable and adverse effects of sodium thiopental-fentanyl (TF) with ketamine-propofol (KP) for procedural sedation and analgesia in the emergency department.
METHODS


After signing written consent, patients were enrolled in this randomised double-blind trial to receive either KP or TF to reach the desired sedation level. The respiratory and haemodynamic complications, nausea and vomiting, recovery agitation, patient recall and satisfaction, provider satisfaction and recovery time were compared.
RESULTS


Of the participants, 47 in the KP group and 49 in the TF group were enrolled. The mean and SD scores were 6.91±1.93 and 8.34±1.25 for patients' satisfaction and 7.55±1.54 and 8.65±1.00 for satisfaction of physicians performing the procedures in TF and KP groups, respectively (p=0.000). Moreover, 39 (79.59%) and 18 (38.29%) of patients declared that they had recalled the procedures in the TF and KP groups, respectively (p=0.000). Transient hypoxia was reported in 2.1% and 8.1% in the KP and TF groups leading to perform 4.2% vs 8.1% airway manoeuvres, respectively, without the need for endotracheal intubation or further admission.
CONCLUSIONS


KP and TF combinations were effectively comparable although KP resulted in higher patient and provider satisfaction. This study did not detect a difference regarding adverse respiratory or haemodynamic effects. It is estimated that the TF combination can be potent and efficacious with possible low adverse events in procedural sedation.",2020,"The mean and SD scores were 6.91±1.93 and 8.34±1.25 for patients' satisfaction and 7.55±1.54 and 8.65±1.00 for satisfaction of physicians performing the procedures in TF and KP groups, respectively (p=0.000).","['Of the participants, 47 in the KP group and 49 in the TF group were enrolled', 'sedation']","['ketamine-propofol (KP', 'KP or TF', 'TF combination', 'ketamine- propofol', 'sodium thiopental-fentanyl (TF', 'sodium thiopental-fentanyl']","['mean and SD scores', 'respiratory and haemodynamic complications, nausea and vomiting, recovery agitation, patient recall and satisfaction, provider satisfaction and recovery time', 'Transient hypoxia']","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",,0.156239,"The mean and SD scores were 6.91±1.93 and 8.34±1.25 for patients' satisfaction and 7.55±1.54 and 8.65±1.00 for satisfaction of physicians performing the procedures in TF and KP groups, respectively (p=0.000).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Bahreini', 'Affiliation': 'Emergency Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Talebi Garekani', 'Affiliation': 'Emergency Department, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Sotoodehnia', 'Affiliation': 'Emergency Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rasooli', 'Affiliation': 'Emergency Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of) fa.rasooli2@gmail.com.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2020-209542']
2879,32859801,Effectiveness of oral motor respiratory exercise and vocal intonation therapy on respiratory function and vocal quality in patients with spinal cord injury: a randomized controlled trial.,"Singing, as a method of combining respiratory function exercise and vocal intonation therapy, provides a new direction for respiratory function exercise in patients with spinal cord injury. This randomized controlled trial investigated the effects of oral motor respiratory exercise and vocal intonation therapy on respiratory function and vocal quality in patients with spinal cord injury. Among 31 included patients with spinal cord injury, 18 completed the treatment. These 18 patients were randomly assigned to undergo music therapy (intervention group, 30 min/d, 5 times a week, for a total of 12 weeks; n = 9, 7 males and 2 females; 30.33 ± 11.74 years old) or normal respiratory training (control group, n = 9; 8 males and 1 female; 34.78 ± 11.13 years old). Both patient groups received routine treatment concurrently. Before and at 6 and 12 weeks after intervention, a standard respiratory function test, a voice test, the St. George's Respiratory Questionnaire, and a quality of life questionnaire were administered. The results showed that the inspiratory capacity, forced expiratory volume in 1 second, forced vital capacity, maximal mid-expiratory flow rate, sing-loud pressure level, and sustained note length were significantly increased in the intervention group compared with the control group. The St. George's Respiratory Questionnaire and quality of life results of patients in the intervention group were significantly superior to those in the control group. These findings suggest that oral motor respiratory exercise and vocal intonation therapy, as respiratory training methods in music therapy, are effective and valuable for improving respiratory dysfunction and vocal quality in patients with spinal cord injury. This study was approved by the Ethics Committee of China Rehabilitation Research Center (approval No. 2019-78-1) on May 27, 2019 and was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1900026922) on October 26, 2019.",2021,The St. George's Respiratory Questionnaire and quality of life results of patients in the intervention group were significantly superior to those in the control group.,"['patients with spinal cord injury', '31 included patients with spinal cord injury, 18 completed the treatment', '18 patients', 'group, n = 9; 8 males and 1 female; 34.78 ± 11.13 years old', '2019-78-1) on May 27, 2019 and was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1900026922) on October 26, 2019']","['normal respiratory training (control', 'respiratory function exercise and vocal intonation therapy', 'oral motor respiratory exercise and vocal intonation therapy', 'music therapy (intervention']","[""St. George's Respiratory Questionnaire and quality of life results"", 'inspiratory capacity, forced expiratory volume in 1 second, forced vital capacity, maximal mid-expiratory flow rate, sing-loud pressure level, and sustained note length', 'respiratory dysfunction and vocal quality', 'respiratory function and vocal quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.0549522,The St. George's Respiratory Questionnaire and quality of life results of patients in the intervention group were significantly superior to those in the control group.,"[{'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders; Music Therapy Center, Department of Psychology, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Yi-Chuan', 'Initials': 'YC', 'LastName': 'Song', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; Music Therapy Center, Department of Psychology, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Chang-Bin', 'Initials': 'CB', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders; Department of Rehabilitation Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Qin', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders; Department of Spinal and Neural Functional Reconstruction, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Song-Huai', 'Initials': 'SH', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; Music Therapy Center, Department of Psychology, China Rehabilitation Research Center, Beijing, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'School of Rehabilitation Medicine, Capital Medical University; China Rehabilitation Science Institute; Beijing Key Laboratory of Neural Injury and Rehabilitation; Center of Neural Injury and Repair, Beijing Institute for Brain Disorders; Department of Spinal and Neural Functional Reconstruction, China Rehabilitation Research Center, Beijing, China.'}]",Neural regeneration research,['10.4103/1673-5374.290909']
2880,32859933,Faecal microbiota transplantation for the treatment of diarrhoea induced by tyrosine-kinase inhibitors in patients with metastatic renal cell carcinoma.,"Diarrhoea is one of the most burdensome and common adverse events of chemotherapeutics, and has no standardised therapy to date. Increasing evidence suggests that the gut microbiome can influence the development of chemotherapy-induced diarrhoea. Here we report findings from a randomised clinical trial of faecal microbiota transplantation (FMT) to treat diarrhoea induced by tyrosine kinase inhibitors (TKI) in patients with metastatic renal cell carcinoma (ClinicalTrials.gov number: NCT04040712). The primary outcome is the resolution of diarrhoea four weeks after the end of treatments. Twenty patients are randomised to receive FMT from healthy donors or placebo FMT (vehicle only). Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces. No serious adverse events are observed in both treatment arms. The trial meets pre-specified endpoints. Our findings suggest that the therapeutic manipulation of gut microbiota may become a promising treatment option to manage TKI-dependent diarrhoea.",2020,"Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces.","['patients with metastatic renal cell carcinoma', 'subjects receiving donor faeces', 'Twenty patients']","['FMT', 'tyrosine kinase inhibitors (TKI', 'placebo FMT', 'faecal microbiota transplantation (FMT', 'Faecal microbiota transplantation', 'Donor FMT']","['resolution of diarrhoea', 'Diarrhoea', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.316226,"Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Ianiro', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Rossi', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Thomas', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Schinzari', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Masucci', 'Affiliation': 'Microbiology Unit, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Quaranta', 'Affiliation': 'Microbiology Unit, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Carlo Romano', 'Initials': 'CR', 'LastName': 'Settanni', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Loris Riccardo', 'Initials': 'LR', 'LastName': 'Lopetuso', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Armanini', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Blanco-Miguez', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Asnicar', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Consolandi', 'Affiliation': 'Institute of Biomedical Technologies (IBT), Italian National Research Council (CNR), Via Fratelli Cervi, 93, 20090, Segrate, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iacovelli', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Sanguinetti', 'Affiliation': 'Microbiology Unit, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Segata', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy. giovanni.cammarota@unicatt.it.'}]",Nature communications,['10.1038/s41467-020-18127-y']
2881,31404539,Do children with a high level of eating motivation consume less when foods are partitioned?,"Eating behaviors, especially the control of intake, are modulated by both internal and external factors. The objective of our study was to examine the effect of the interaction between eating motivation (as an internal factor) and food partition (as an external factor) on chocolate intake in children, with the hypothesis, based on the paradigm of motivated perception, that the effect of partition, i.e. reduced intake, is higher for children with a high level of eating motivation than for other children. A mixed model design was used in which 80 children aged 8-11 yrs. were offered, in their natural setting, two standardized afternoon snacks that included, among other things, 100 g of chocolate presented once as a whole (one bar) and once segmented (six pieces). The amount of chocolate eaten was weighed and compared between conditions (Bar vs Pieces). Children completed questionnaires in order to assess two of their eating motivational features (appetite arousal, chocolate specific appetite). Results indicated no effect of Partition: children ate the same quantity of chocolate in the two conditions (Bar or Pieces). Only chocolate specific appetite was associated with the amount of chocolate eaten, with children with a higher level eating more than other children (+13 g). Contrary to adults, children are not influenced by the ""many is more effect"". Methodological and developmental interpretations were suggested, linked to the size of the portion, the network of attention and the sensibility to the external cues underlying the control of intake.",2019,"Only chocolate specific appetite was associated with the amount of chocolate eaten, with children with a higher level eating more than other children (+13 g).","['80 children aged 8-11\u202fyrs. were offered, in their natural setting, two standardized afternoon snacks that included, among other things, 100\u202fg of chocolate presented once as a whole (one bar) and once segmented (six pieces', 'children with a high level of eating motivation than for other children']",[],"['Eating behaviors', 'eating motivational features (appetite arousal, chocolate specific appetite']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0585347', 'cui_str': 'Single event'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205452', 'cui_str': '6'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",[],"[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",80.0,0.0333918,"Only chocolate specific appetite was associated with the amount of chocolate eaten, with children with a higher level eating more than other children (+13 g).","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rigal', 'Affiliation': 'Department of Psychology, University Paris Nanterre, 200 avenue de la République, 92000 Nanterre, France. Electronic address: rigal@parisnanterre.fr.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Champel', 'Affiliation': 'Department of Psychology, University Paris Nanterre, 200 avenue de la République, 92000 Nanterre, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112636']
2882,31409394,Immune microenvironment modulation unmasks therapeutic benefit of radiotherapy and checkpoint inhibition.,"BACKGROUND


Immune checkpoint inhibitors (ICIs) for solid tumors, including those targeting programmed cell death 1 (PD-1) and cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), have shown impressive clinical efficacy, however, most patients do not achieve durable responses. One major therapeutic obstacle is the immunosuppressive tumor immune microenvironment (TIME). Thus, we hypothesized that a strategy combining tumor-directed radiation with TIME immunomodulation could improve ICI response rates in established solid tumors.
METHODS


Using a syngeneic mouse model of human papillomavirus (HPV)-associated head and neck cancer, mEER, we developed a maximally effective regimen combining PD-1 and CTLA-4 inhibition, tumor-directed radiation, and two existing immunomodulatory drugs: cyclophosphamide (CTX) and a small-molecule inducible nitric oxide synthase (iNOS) inhibitor, L-n6-(1-iminoethyl)-lysine (L-NIL). We compared the effects of the various combinations of this regimen on tumor growth, overall survival, establishment of immunologic memory, and immunologic changes with flow cytometry and quantitative multiplex immunofluorescence.
RESULTS


We found PD-1 and CTLA-4 blockade, and radiotherapy alone or in combination, incapable of clearing established tumors or reversing the unfavorable balance of effector to suppressor cells in the TIME. However, modulation of the TIME with cyclophosphamide (CTX) and L-NIL in combination with dual checkpoint inhibition and radiation led to rejection of over 70% of established mEER tumors and doubled median survival in the B16 melanoma model. Anti-tumor activity was CD8 +  T cell-dependent and led to development of immunologic memory against tumor-associated HPV antigens. Immune profiling revealed that CTX/L-NIL induced remodeling of myeloid cell populations in the TIME and tumor-draining lymph node and drove subsequent activation and intratumoral infiltration of CD8 +  effector T cells.
CONCLUSIONS


Overall, this study demonstrates that modulation of the immunosuppressive TIME is required to unlock the benefits of ICIs and radiotherapy to induce immunologic rejection of treatment-refractory established solid tumors.",2019,Anti-tumor activity was CD8 +  T cell-dependent and led to development of immunologic memory against tumor-associated HPV antigens.,"['human papillomavirus (HPV)-associated head and neck cancer, mEER']","['cyclophosphamide (CTX', 'radiotherapy and checkpoint inhibition', 'radiotherapy']","['tumor growth, overall survival, establishment of immunologic memory, and immunologic changes with flow cytometry and quantitative multiplex immunofluorescence', 'ICI response rates', 'median survival']","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021055', 'cui_str': 'Immunologic memory'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0016318', 'cui_str': 'Fluorescent identification of anti-nuclear antibody'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0597153,Anti-tumor activity was CD8 +  T cell-dependent and led to development of immunologic memory against tumor-associated HPV antigens.,"[{'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Newton', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Hanoteau', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Hsuan-Chen', 'Initials': 'HC', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Gaspero', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Falguni', 'Initials': 'F', 'LastName': 'Parikh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Robyn D', 'Initials': 'RD', 'LastName': 'Gartrell-Corrado', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Hematology/Oncology, Columbia University Irving Medical Center/New York Presbyterian, New York, NY, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Columbia University Irving Medical Center/New York Presbyterian, New York, NY, USA.'}, {'ForeName': 'Damya', 'Initials': 'D', 'LastName': 'Laoui', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Jo A', 'Initials': 'JA', 'LastName': 'Van Ginderachter', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Neeraja', 'Initials': 'N', 'LastName': 'Dharmaraj', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Spanos', 'Affiliation': 'Department of Surgery, University of South Dakota, Sanford School of Medicine, Vermillion, SD, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Saenger', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Columbia University Irving Medical Center/New York Presbyterian, New York, NY, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Sikora', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, TX, USA. Andrew.Sikora@bcm.edu.'}]",Journal for immunotherapy of cancer,['10.1186/s40425-019-0698-6']
2883,31652321,"Is radiographic progression a downside of stopping TNF-inhibitor in RA patients with low disease activity, if this is followed by flare? A sub-study of the POET-US trial.",,2020,,['RA patients with low disease activity'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],[],,0.019595,,"[{'ForeName': 'Femke B G', 'Initials': 'FBG', 'LastName': 'Lamers-Karnebeek', 'Affiliation': 'Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen.'}, {'ForeName': 'Jolanda J', 'Initials': 'JJ', 'LastName': 'Luime', 'Affiliation': 'Department of Rheumatology, Erasmus Medical Center, Rotterdam.'}, {'ForeName': 'Tim L', 'Initials': 'TL', 'LastName': 'Jansen', 'Affiliation': 'Department of Rheumatology, Viecuri Medical Center, Venlo.'}, {'ForeName': 'Piet L C M', 'Initials': 'PLCM', 'LastName': 'van Riel', 'Affiliation': 'Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen.'}, {'ForeName': 'Johannes W G', 'Initials': 'JWG', 'LastName': 'Jacobs', 'Affiliation': ''}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez488']
2884,32856530,Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement.,"Background Gait speed is a reliable measure of physical function and frailty in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Slow gait speed pre-TAVR predicts worse clinical outcomes post-TAVR. The consequences of improved versus worsened physical function post-TAVR are unknown. Methods and Results The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial randomized high/extreme risk patients to receive a mechanically-expanded or self-expanding transcatheter heart valve. Of 874 patients who underwent TAVR, 576 with complete data at baseline and 1 year were included in this analysis. Slow gait speed in the 5-m walk test was defined as <0.83 m/s. A clinically meaningful improvement (≥0.1 m/s) in gait speed 1 year after TAVR occurred in 39% of patients, 35% exhibited no change, and 26% declined (≥0.1 m/s). Among groups defined by baseline/1-year post-TAVR gait speeds, 1- to 2-year mortality or hospitalization rates were as follows: 6.6% (normal/normal), 8.0% (slow/normal), 20.9% (normal/slow), and 21.5% (slow/slow). After adjustment, slow gait speed at 1 year (regardless of baseline speed) was associated with a 3.5-fold increase in death/hospitalization between 1 and 2 years compared with those with normal baseline/1-year gait speed. Patients whose slow gait speed normalized at 1 year had no increased risk. One-year, but not baseline, gait speed was associated with death or hospitalization between 1 and 2 years (adjusted hazard ratio, 0.83 per 0.1 m/s faster gait; 95% CI, 0.74-0.93,  P =0.001). Conclusions Marked heterogeneity exists in the trajectory of physical function after TAVR and this, more than baseline function, has clinical consequences. Identifying and optimizing factors associated with physical resilience after TAVR may improve outcomes. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02202434.",2020,"m/s faster gait; 95% CI, 0.74-0.93,  P =0.001).","['Patients Undergoing Transcatheter Aortic Valve Replacement', '874 patients who underwent TAVR, 576 with complete data at baseline and 1 year were included in this analysis', 'patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR']","['mechanically-expanded or self-expanding transcatheter heart valve', 'Registration URL']","['death or hospitalization', 'gait speed 1\xa0year after TAVR', 'slow gait speed normalized', 'slow gait speed', '2-year mortality or hospitalization rates', 'death/hospitalization', 'Slow gait speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",874.0,0.151714,"m/s faster gait; 95% CI, 0.74-0.93,  P =0.001).","[{'ForeName': 'Kashish', 'Initials': 'K', 'LastName': 'Goel', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': ""O'Leary"", 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Barker', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Levack', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Rajagopal', 'Affiliation': 'Marcus Heart Valve Center Piedmont Heart Institute Atlanta GA.'}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Smidt Heart Institute, Cedars - Sinai Heart Institute Los Angeles CA.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Bajwa', 'Affiliation': ""Aurora Cardiovascular Services Aurora Sinai/Aurora St. Luke's Medical Centers Milwaukee WI.""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Kleiman', 'Affiliation': 'Department of Cardiovascular Surgery Houston Methodist DeBakey Heart and Vascular Center Houston TX.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Department of Internal Medicine and Cardiology Heart Center Dresden Technical University of Dresden Germany.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center Lindner Research Center Cincinnati OH.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Allocco', 'Affiliation': 'Clinical Sciences Boston Scientific Corp Marlborough MA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Rizik', 'Affiliation': 'HonorHealth and the Scottsdale-Lincoln Health Network Scottsdale AZ.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Cardiovascular Surgery Houston Methodist DeBakey Heart and Vascular Center Houston TX.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lindman', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017075']
2885,32856547,Short-term effects of nicotine gum on facial detection in healthy nonsmokers: a pilot randomized controlled trial.,"OBJECTIVE


The main purpose of this study was to investigate short-term effects of nicotine gum on facial detection. Methods: Fourteen participants (mean age = 26.8 years, SD = 2.5 years; eight males) were enrolled in this pilot randomized controlled trial of nicotine gum administration (placebo, 2-mg and 4-mg doses). The participants were instructed to detect the location of a face when it was presented in a face/nonface pair on the screen. A repeated multivariate analysis of variance was conducted to analyze the results for reaction time and discrimination index. Demographics were used to explore significant association on facial detection. Bayesian analyses were also carried out considering maximum robustness to avoid bias.  Results:  The results indicated that the 2-mg dose resulted in faster reaction time and better discrimination than the 4-mg dose (p < 0.001). The 4-mg dose resulted in slower reaction time and lower discrimination index compared to both placebo (p < 0.01) and 2-mg doses (p < 0.001). Demographic data were not related to the outcomes.  Conclusions:  The results indicate that nicotine improved facial detection, but only at low doses (i.e., 2-mg), following a U-shaped curve. We trust future studies will continue to advance this research field, and if further work supports these preliminary findings, nicotine can act as therapeutic target in populations such as those with low vision.",2020,The 4-mg dose resulted in slower reaction time and lower discrimination index compared to both placebo (p < 0.01) and 2-mg doses (p < 0.001).,"['healthy nonsmokers', 'Fourteen participants (mean age = 26.8\u2009years, SD = 2.5\u2009years; eight males']","['nicotine gum', 'placebo', 'nicotine gum administration (placebo', 'nicotine']","['reaction time and discrimination index', 'facial detection', 'faster reaction time and better discrimination', 'slower reaction time and lower discrimination index']","[{'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",14.0,0.0472478,The 4-mg dose resulted in slower reaction time and lower discrimination index compared to both placebo (p < 0.01) and 2-mg doses (p < 0.001).,"[{'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Joao Pessoa, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, Orangeburg, NY, USA.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Joao Pessoa, Brazil.'}, {'ForeName': 'Gabriella M', 'Initials': 'GM', 'LastName': 'Silva', 'Affiliation': 'Federal University of Paraiba, Joao Pessoa, Brazil.'}, {'ForeName': 'Marcos V', 'Initials': 'MV', 'LastName': 'Anchieta', 'Affiliation': 'Federal University of Paraiba, Joao Pessoa, Brazil.'}, {'ForeName': 'Jandirlly J S', 'Initials': 'JJS', 'LastName': 'Souto', 'Affiliation': 'Federal University of Paraiba, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H V', 'Initials': 'GHV', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Joao Pessoa, Brazil.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Joao Pessoa, Brazil.'}]",Journal of addictive diseases,['10.1080/10550887.2020.1805093']
2886,32856709,The Relationship between Urine Uromodulin and Blood Pressure Changes: the DASH-Sodium Trial.,"BACKGROUND


Uromodulin modulates the sodium-potassium-two-chloride transporter in the thick ascending limb of the loop of Henle, and its overexpression in murine models leads to salt-induced hypertension. We hypothesized that individuals with higher baseline levels of urine uromodulin will have a greater increase in systolic blood pressure (SBP) for the same increase in sodium compared to those with lower uromodulin levels.
METHODS


We used data from 157 subjects randomized to the control diet of the DASH-Sodium trial who were assigned to 30 days of low (1500 mg/d), medium (2400 mg/d), and high salt (3300 mg/d) diets in random order. Blood pressure was measured pre-randomization, and then weekly and at five visits during the last nine days of each feeding period. We evaluated the association of pre-randomization urine uromodulin with change in SBP between diets, as measured by the average at the end of each feeding period, using multivariable linear regression.
RESULTS


Baseline urine uromodulin stratified by tertiles was ≤17.64, 17.65 - 31.97, and ≥31.98 μg/mL. Across the tertiles, there were no significant differences in SBP at baseline, nor was there a differential effect of sodium diet on SBP across tertiles (low to high, p = 0.81). After adjusting for age, sex, body mass index, and race, uromodulin levels were not significantly associated with SBP change from low to high sodium diet (p = 0.42).
CONCLUSIONS


In a randomized trial of different levels of salt intake, higher urine uromodulin levels were not associated with a greater increase in blood pressure in response to high salt intake.",2020,"RESULTS


Baseline urine uromodulin stratified by tertiles was ≤17.64, 17.65 - 31.97, and ≥31.98 μg/mL. Across the tertiles, there were no significant differences in SBP at baseline, nor was there a differential effect of sodium diet on SBP across tertiles (low to high, p = 0.81).",['157 subjects randomized to the control diet of the DASH-Sodium trial'],[],"['SBP change', 'systolic blood pressure (SBP', 'blood pressure', 'Blood pressure', 'SBP']","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",157.0,0.0186036,"RESULTS


Baseline urine uromodulin stratified by tertiles was ≤17.64, 17.65 - 31.97, and ≥31.98 μg/mL. Across the tertiles, there were no significant differences in SBP at baseline, nor was there a differential effect of sodium diet on SBP across tertiles (low to high, p = 0.81).","[{'ForeName': 'C Y', 'Initials': 'CY', 'LastName': 'Bakhoum', 'Affiliation': 'Department of Pediatrics, The University of California San Diego, La Jolla, CA.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'Anderson', 'Affiliation': 'School of Public Health and Longevity Science, The University of California San Diego, La Jolla, CA.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Rebholz', 'Affiliation': 'Department of Epidemiology, John Hopkins University, Baltimore, MD.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, John Hopkins University, Baltimore, MD.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, John Hopkins University, Baltimore, MD.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Department of Epidemiology, John Hopkins University, Baltimore, MD.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Obeid', 'Affiliation': 'Division of Nephrology, John Hopkins University, Baltimore, MD.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, La Jolla, CA.'}]",American journal of hypertension,['10.1093/ajh/hpaa140']
2887,32856734,Volume-dependent effect of stored red blood cells: A secondary analysis of the Age of Blood Evaluation trial.,"BACKGROUND


An increased risk of complications, including death, has been associated with stored red blood cell (RBC) units in observational studies but not in randomized trials. We aimed to evaluate for volume-dependent effects attributable to length of RBC storage in a secondary analysis of the Age of Blood Evaluation (ABLE) trial.
STUDY DESIGN AND METHODS


In the 2510 critically ill adults from the ABLE trial randomized to receive RBC units stored not more than 7 days or the oldest compatible RBC units, we estimated the hazard ratio (HR) for death by intensive care unit (ICU) and hospital discharge and by days 28, 90, and 180, within subgroups defined by the number of RBC units received. Extended Cox proportional hazards regression was used to model the HR.
RESULTS


A volume-dependent effect of storage age on survival was present for death by 90 and 180 days, but not earlier endpoints. The HR for death by 90 days was 0.55 (95% confidence interval [CI], 0.11-0.98, fresh vs standard) after transfusion of 6 RBC units but 1.45 (95% CI, 1.06-1.98) after transfusion of 1 RBC unit.
CONCLUSION


In this exploratory analysis, volume-dependent effects related to RBC storage were documented in the ABLE trial. The harms associated with small volumes of fresh RBC units and large volumes of older RBC units should be further explored.",2020,"The HR for death by 90 days was 0.55 (95% confidence interval [CI], 0.11-0.98, fresh vs standard) after transfusion of 6 RBC units but 1.45 (95% CI, 1.06-1.98) after transfusion of 1 RBC unit.
",['2510 critically ill adults'],"['RBC', 'stored red blood cells']","['RBC storage', 'storage age on survival', 'HR for death', 'hazard ratio (HR) for death by intensive care unit (ICU) and hospital discharge']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1698986', 'cui_str': 'Storage'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",2510.0,0.235596,"The HR for death by 90 days was 0.55 (95% confidence interval [CI], 0.11-0.98, fresh vs standard) after transfusion of 6 RBC units but 1.45 (95% CI, 1.06-1.98) after transfusion of 1 RBC unit.
","[{'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Mack', 'Affiliation': 'Department of Medicine, Ottawa General Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine and Lady Davis Institute, Jewish General Hospital, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tinmouth', 'Affiliation': 'Department of Medicine, Ottawa General Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Hébert', 'Affiliation': 'Division of Critical Care, Centre Hospitalier Universitaire de Montréal, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lacroix', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15933']
2888,32856785,"Effects of high-intensity exercise training on physical fitness, quality of life and treatment outcomes after oesophagectomy for cancer of the gastro-oesophageal junction: PRESET pilot study.","BACKGROUND


Treatment for cancer of the gastro-oesophageal junction (GOJ) can result in considerable and persistent impairment of physical fitness and health-related quality of life (HRQoL). This controlled follow-up study investigated the feasibility and safety of postoperative exercise training.
METHODS


Patients with stage I-III GOJ cancer were allocated to 12 weeks of postoperative concurrent aerobic and resistance training (exercise group) or usual care (control group). Changes in cardiorespiratory fitness, muscle strength and HRQoL were evaluated. Adherence to adjuvant chemotherapy, hospitalizations and 1-year overall survival were recorded to assess safety.
RESULTS


Some 49 patients were studied. The exercise group attended a mean of 69 per cent of all prescribed sessions. After exercise, muscle strength and cardiorespiratory fitness were increased and returned to pretreatment levels. At 1-year follow-up, the exercise group had improved HRQoL (+13·5 points, 95 per cent c.i. 2·2 to 24·9), with no change in the control group (+3·7 points, -5·9 to 13·4), but there was no difference between the groups at this time point (+9·8 points, -5·1 to 24·8). Exercise was safe, with no differences in patients receiving adjuvant chemotherapy (14 of 16 versus 16 of 19; relative risk (RR) 1·04, 95 per cent c.i. 0·74 to 1·44), relative dose intensity of adjuvant chemotherapy (mean 57 versus 63 per cent; P = 0·479), hospitalization (7 of 19 versus 6 of 23; RR 1·41, 0·57 to 3·49) or 1-year overall survival (80 versus 79 per cent; P = 0·839) for exercise and usual care respectively.
CONCLUSION


Exercise in the postoperative period is safe and may have the potential to improve physical fitness in patients with GOJ cancer. No differences in prognostic endpoints or HRQoL were observed. Registration number: NCT02722785 ( https://www.clinicaltrials.gov).",2020,"Exercise was safe, with no differences in patients receiving adjuvant chemotherapy (14 of 16 versus 16 of 19; relative risk (RR) 1·04, 95 per cent c.i.","['49 patients were studied', 'I-III GOJ cancer', 'patients with GOJ cancer', 'after oesophagectomy for cancer of the gastro-oesophageal junction', 'Patients with stage']","['postoperative concurrent aerobic and resistance training (exercise group) or usual care (control group', 'postoperative exercise training', 'Exercise', 'high-intensity exercise training', 'adjuvant chemotherapy']","['hospitalization', 'muscle strength and cardiorespiratory fitness', 'physical fitness', 'physical fitness, quality of life and treatment outcomes', 'prognostic endpoints or HRQoL', 'HRQoL', 'relative dose intensity of adjuvant chemotherapy', '1-year overall survival', 'cardiorespiratory fitness, muscle strength and HRQoL', 'Adherence to adjuvant chemotherapy, hospitalizations and 1-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",49.0,0.0909348,"Exercise was safe, with no differences in patients receiving adjuvant chemotherapy (14 of 16 versus 16 of 19; relative risk (RR) 1·04, 95 per cent c.i.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Simonsen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thorsen-Streit', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sundberg', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Djurhuus', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Mortensen', 'Affiliation': 'Departments of Oncology, Copenhagen, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Qvortrup', 'Affiliation': 'Departments of Oncology, Copenhagen, Denmark.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Svendsen', 'Affiliation': 'Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Heer', 'Affiliation': 'Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Christensen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",BJS open,['10.1002/bjs5.50337']
2889,32856870,Effect of Muscle Energy Techniques V/S Active Range of Motion Exercises on Shoulder Function Post Modified Radical Neck Dissection in patients with Head and Neck Cancer - A Randomized Clinical Trial.,"PURPOSE


Shoulder and cervical pain, reduced mobility and disability are some of the major complications associated with surgeries of head and neck cancers affecting several domains of quality of life. In the present study we aimed to compare the effectiveness of Muscle Ener-gy Techniques (METS) and Active Range of Motion Exercises in reducing pain, improving shoulder mobility and function in patients post Modified Radical Neck Dissection (MRND).
METHODS


Forty eight subjects were randomly assigned to two groups. Group A received active range of motion (AROM) exercises and group B received Muscle energy techniques (METS). Both the groups were treated for a period of 10 consecutive days starting from the  3rd to 5th postoperative day. Data was collected on the 1st and 10th day of intervention.
RESULTS


Both groups showed highly significant improvements in shoulder range of motion , decrease in pain and better Global Rating Change cores(GRCS) (p=0.005). GRCS and shoul-der abduction showed significant improvement in group B when compared to group A, sug-gesting better clinical outcomes in those treated with Muscle Energy Techniques.  Conclusion: This study showed that both METs and AROM exercises were effective in im-proving shoulder range of motion, function and reducing pain in patients post MRND but-Muscle Energy Techniques were more effective when compared to AROM exercises.<br />.",2020,"GRCS and shoul-der abduction showed significant improvement in group B when compared to group A, sug-gesting better clinical outcomes in those treated with Muscle Energy Techniques.  ","['patients with Head and Neck Cancer ', 'patients post Modified Radical Neck Dissection (MRND', 'Forty eight subjects']","['Muscle Ener-gy Techniques (METS) and Active Range of Motion Exercises', 'active range of motion (AROM) exercises and group B received Muscle energy techniques (METS', 'Muscle Energy Techniques V/S Active Range of Motion Exercises', 'METs and AROM exercises', 'Modified Radical Neck Dissection']","['shoulder range of motion , decrease in pain and better Global Rating Change cores(GRCS', 'GRCS and shoul-der abduction', 'Shoulder Function Post']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0193864', 'cui_str': 'Modified radical neck dissection'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0193864', 'cui_str': 'Modified radical neck dissection'}]","[{'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",48.0,0.0420535,"GRCS and shoul-der abduction showed significant improvement in group B when compared to group A, sug-gesting better clinical outcomes in those treated with Muscle Energy Techniques.  ","[{'ForeName': 'Anmol', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'MPT Father Muller Medical College Hospital, Mangalore, Karnataka, India.'}, {'ForeName': 'Cherishma', 'Initials': 'C', 'LastName': ""D'Silva"", 'Affiliation': 'Department of Physiotherapy, Father Muller Medical College Hospital, Mangalore, Karnataka, India.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Mohandas', 'Affiliation': 'Department of Physiotherapy, Father Muller Medical College Hospital, Mangalore, Karnataka, India.'}, {'ForeName': 'Sudeep M J', 'Initials': 'SMJ', 'LastName': 'Pais', 'Affiliation': 'Department of Physiotherapy, Father Muller Medical College Hospital, Mangalore, Karnataka, India.'}, {'ForeName': 'Stephen Rajan', 'Initials': 'SR', 'LastName': 'Samuel', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College Mangalore, Karnataka, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.8.2389']
2890,31280133,Increased sharing between collaborators extends beyond the spoils of collaboration.,"Research has shown that preschoolers increase equal sharing after collaborating to earn resources, suggesting that collaboration may be an important context for the development of fairness. The current study explored the influence of specific components of collaborative interactions to better understand the social cognitive foundations of this precocious increase in equal sharing. The effects of three forms of collaborative interaction on children's sharing were compared: collaborating toward a joint concrete goal of earning resources that could subsequently be shared, collaborating toward a joint concrete goal without earning resources, and playing a social game without earning resources. Replicating previous work, a significant increase in the proportion of equal sharing was observed when children shared collaboratively earned resources. Extending these findings, collaboration toward a concrete goal resulted in increased sharing regardless of whether resources were earned collaboratively or given outside of the collaborative context. Social play alone was not found to influence children's sharing, highlighting the importance of the context of collaboration toward a concrete goal to increase children's sharing. Overall, these findings suggest that collaborating toward a shared concrete goal fosters a general increase in prosociality that extends beyond the context of sharing collaboratively earned resources.",2019,"Social play alone was not found to influence children's sharing, highlighting the importance of the context of collaboration toward a concrete goal to increase children's sharing.",[],[],['proportion of equal sharing'],[],[],"[{'cui': 'C0205163', 'cui_str': 'Equal'}]",,0.0226381,"Social play alone was not found to influence children's sharing, highlighting the importance of the context of collaboration toward a concrete goal to increase children's sharing.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Corbit', 'Affiliation': 'Department of Psychology, St. Francis Xavier University, Antigonish, Nova Scotia B2G 2W5, Canada. Electronic address: jcorbit@stfx.ca.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.06.003']
2891,31639034,Very early MRI responses to therapy as a predictor of later radiographic progression in early rheumatoid arthritis.,"BACKGROUND


The objective of this study was to evaluate early changes in magnetic resonance imaging (MRI) and clinical disease activity measures as predictors of later structural progression in early rheumatoid arthritis (RA).
METHODS


This was a post hoc analysis of data pooled across treatments from a three-arm (tofacitinib monotherapy, tofacitinib with methotrexate [MTX], or MTX monotherapy) trial of MTX-naïve patients with early, active RA. Synovitis, osteitis and erosions were assessed with the Outcome Measures in Rheumatology (OMERACT) RA MRI scoring system (RAMRIS) and RAMRIQ (automated quantitative RA MRI assessment system; automated RAMRIS) at months 0, 1, 3, 6 and 12. Radiographs were assessed at months 0, 6 and 12, and clinical endpoints were assessed at all timepoints. Univariate and multivariate analyses explored the predictive value of early changes in RAMRIS/RAMRIQ parameters and disease activity measures, with respect to subsequent radiographic progression.
RESULTS


Data from 109 patients with a mean RA duration of 0.7 years were included. In univariate analyses, changes in RAMRIS erosions at months 1 and 3 significantly predicted radiographic progression at month 12 (both p <  0.01); changes in RAMRIQ synovitis and osteitis at months 1 and 3 were significant predictors of RAMRIS erosions and radiographic progression at month 12 (all p <  0.01). In subsequent multivariate analyses, RAMRIS erosion change at month 1 (p <  0.05) and RAMRIQ osteitis changes at months 1 and 3 (both p <  0.01) were significant independent predictors of radiographic progression at month 12. Univariate analyses demonstrated that changes in Clinical Disease Activity Index (CDAI) and Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]) at months 1 and 3 were not predictive of month 12 radiographic progression.
CONCLUSIONS


MRI changes seen as early as 1 month after RA treatment initiation have the potential to better predict long-term radiographic progression than changes in disease activity measures.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01164579 .",2019,"In subsequent multivariate analyses, RAMRIS erosion change at month 1 (p <  0.05) and RAMRIQ osteitis changes at months 1 and 3 (both p <  0.01) were significant independent predictors of radiographic progression at month 12.","['naïve patients with early, active RA', 'early rheumatoid arthritis (RA', '109 patients with a mean RA duration of 0.7\u2009years were included']","['MTX', 'methotrexate [MTX', 'magnetic resonance imaging (MRI']","['RAMRIS erosions', 'RAMRIS erosion change', 'RAMRIQ synovitis and osteitis', 'Synovitis, osteitis and erosions', 'RAMRIQ osteitis changes', 'Clinical Disease Activity Index (CDAI) and Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR', 'Rheumatology (OMERACT) RA MRI scoring system (RAMRIS) and RAMRIQ (automated quantitative RA MRI assessment system; automated RAMRIS', 'RAMRIS erosions and radiographic progression', 'radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0029400', 'cui_str': 'Osteitis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",109.0,0.0318563,"In subsequent multivariate analyses, RAMRIS erosion change at month 1 (p <  0.05) and RAMRIQ osteitis changes at months 1 and 3 (both p <  0.01) were significant independent predictors of radiographic progression at month 12.","[{'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and UK National Institute for Health Research Leeds Biomedical Research Centre, Leeds, UK. P.Conaghan@leeds.ac.uk.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Troum', 'Affiliation': 'Division of Rheumatology, University of Southern California Keck School of Medicine, Santa Monica, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics Ltd, Worthington House, Towers Business Park, Manchester, UK.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Guillard', 'Affiliation': 'Imorphics Ltd, Worthington House, Towers Business Park, Manchester, UK.'}, {'ForeName': 'Bethanie', 'Initials': 'B', 'LastName': 'Wilkinson', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Biostatistics Department, IQVIA Inc, Morrisville, NC, USA.'}, {'ForeName': 'Douglass', 'Initials': 'D', 'LastName': 'Chapman', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koenig', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}]",Arthritis research & therapy,['10.1186/s13075-019-2000-1']
2892,32857060,An Image-Based Mobile Health App for Postdrainage Monitoring: Usability Study.,"BACKGROUND


The application of mobile health (mHealth) platforms to monitor recovery in the postdischarge period has increased in recent years. Despite widespread enthusiasm for mHealth, few studies have evaluated the usability and user experience of mHealth in patients with surgical drainage.
OBJECTIVE


Our objectives were to (1) develop an image-based smartphone app, SurgCare, for postdrainage monitoring and (2) determine the feasibility and clinical value of the use of SurgCare by patients with drainage.
METHODS


We enrolled 80 patients with biliary or peritoneal drainage in this study. A total of 50 patients were assigned to the SurgCare group, who recorded drainage monitoring data with the smartphone app; and 30 patients who manually recorded the data were assigned to the conventional group. The patients continued to record data until drain removal. The primary aim was to validate feasibility for the user, which was defined as the proportion of patients using each element of the system. Moreover, the secondary aim was to evaluate the association of compliance with SurgCare and the occurrence of unexpected events.
RESULTS


The average submission duration was 14.98 days, and the overall daily submission rate was 84.2%. The average system usability scale was 83.7 (SD 3.5). This system met the definition of ""definitely feasible"" in 34 patients, ""possibly feasible"" in 10 patients, and ""not feasible"" in 3 patients. We found that the occurrence rates of complications in the SurgCare group and the conventional group were 6% and 26%, respectively, with statistically significant differences P=.03. The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
CONCLUSIONS


Patients can learn to use a smartphone app for postdischarge drainage monitoring with high levels of user satisfaction. We also identified a high degree of compliance with app-based drainage-recording design features, which is an aspect of mHealth that can improve surgical care.",2020,"The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
","['patients with surgical drainage', 'patients with drainage', '50 patients were assigned to the SurgCare group, who recorded drainage monitoring data with the smartphone app; and 30 patients who manually recorded the data were assigned to the conventional group', '80 patients with biliary or peritoneal drainage in this study']",[],"['average submission duration', 'rate of unexpected hospital return', 'occurrence rates of complications', 'average system usability scale', 'overall daily submission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",80.0,0.040476,"The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
","[{'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Liao', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Yu-Tung', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chi-Tung', 'Initials': 'CT', 'LastName': 'Cheng', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chun-Hsiang', 'Initials': 'CH', 'LastName': 'Ooyang', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Shih-Ching', 'Initials': 'SC', 'LastName': 'Kang', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chih-Yuan', 'Initials': 'CY', 'LastName': 'Fu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Yu-Pao', 'Initials': 'YP', 'LastName': 'Hsu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chi-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chih-Chi', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}]",Journal of medical Internet research,['10.2196/17686']
2893,32857128,"Long-term Effects of Calcium β-Hydroxy-β-methylbutyrate (HMB) and Vitamin D3 Supplementation on Muscular Function in Older Adults with and without Resistance Training: A Randomized, Double-blind, Controlled Study.","The primary aim of this study was to determine whether supplementation with calcium β-hydroxy-β-methylbutyrate (HMB) and Vitamin D3 (D) would enhance muscle function and strength in older adults. Older adults over 60 years of age with insufficient circulating 25-hydroxy-Vitamin D (25OH-D) levels were enrolled in a double-blinded controlled 12-month study. Study participants were randomly assigned to treatments consisting of: (a) Control + no exercise; (b) HMB+D + no exercise; (c) Control + exercise, and (d) HMB+D + exercise. The study evaluated 117 participants consisting of multiple measurements over the 12 months that included body composition, strength, functionality, and questionnaires. HMB+D had a significant benefit on lean body mass within the non-exercise group at 6 months (0.44±0.27kg, HMB+D vs. -0.33±0.28kg control, p<0.05). In non-exercisers, improvement in knee extension peak torque (60°/sec) was significantly greater in HMB+D supplemented participants than in non-supplemented group (p=0.04) at 3 months, 10.9 ± 5.7Nm and -5.2 ± 5.9Nm, respectively. A composite functional index, integrating changes in handgrip, Get Up, and Get Up and Go measurements, was developed. HMB+D + no exercise resulted in significant increases in the functional index compared to those observed in the control + no exercise group at 3 (p=0.03), 6 (p=0.04), and 12 months (p=0.04). Supplementation with HMB+D did not further improve the functional index within the exercising group. This study demonstrated the potential of HMB and Vitamin D3 supplementation to enhance muscle strength and physical functionality in older adults, even in individuals not engaged in an exercise training program.",2020,"In non-exercisers, improvement in knee extension peak torque (60°/sec) was significantly greater in HMB+D supplemented participants than in non-supplemented group (p=0.04) at 3 months, 10.9 ± 5.7Nm and -5.2 ± 5.9Nm, respectively.","['older adults', 'Older Adults with and without Resistance Training', 'Older adults over 60 years of age with insufficient circulating 25-hydroxy-Vitamin D (25OH-D) levels', 'older adults, even in individuals not engaged in an exercise training program', '117 participants consisting of multiple measurements over the 12 months that included body composition, strength, functionality, and questionnaires']","['Calcium β-Hydroxy-β-methylbutyrate (HMB) and Vitamin D3 Supplementation', 'Control + no exercise; (b) HMB+D + no exercise; (c) Control + exercise, and (d) HMB+D + exercise', 'HMB and Vitamin D3 supplementation', 'calcium β-hydroxy-β-methylbutyrate (HMB) and Vitamin D3 (D', 'HMB+D + no exercise', 'HMB+D']","['Muscular Function', 'muscle strength and physical functionality', 'lean body mass', 'functional index', 'knee extension peak torque']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",117.0,0.119148,"In non-exercisers, improvement in knee extension peak torque (60°/sec) was significantly greater in HMB+D supplemented participants than in non-supplemented group (p=0.04) at 3 months, 10.9 ± 5.7Nm and -5.2 ± 5.9Nm, respectively.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Rathmacher', 'Affiliation': 'MTI BioTech, Inc., Iowa State University Research Park, Ames, IA, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'MTI BioTech, Inc., Iowa State University Research Park, Ames, IA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khoo', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Angus', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lowry', 'Affiliation': 'Department of Physical Therapy, Des Moines University, Des Moines, IA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ruby', 'Affiliation': 'Department of Physical Therapy, Des Moines University, Des Moines, IA, USA.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Krajek', 'Affiliation': 'Department of Physical Therapy, Des Moines University, Des Moines, IA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fuller', 'Affiliation': 'Metabolic Technologies, LLC, Missoula, MT, USA.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Sharp', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA, USA.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa218']
2894,32857151,Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial.,"Importance


Palliative care has shown benefits in reducing symptom intensity and quality of life in patients with advanced cancer. However, high-quality evidence to support palliative care policy and service developments for patients with long-term neurological conditions (LTNCs) is lacking.
Objective


To determine the effectiveness of a short-term integrated palliative care (SIPC) intervention for people with LTNCs.
Design, Setting, and Participants


Multicenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services. A total of 535 patients with LTNC were assessed for eligibility and 350 were randomized. Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy. Data were analyzed from November 2018 to March 2019.
Interventions


Patients were randomized 1:1 using minimization method to receive SIPC (intervention, n = 176) or standard care (control, n = 174).
Main Outcomes and Measures


Primary outcome was change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions. Secondary outcomes included change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs. Data were collected and analyzed blindly by intention to treat.
Results


A total of 350 patients (mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n = 229). There were no between-group differences in primary outcome (effect size, -0.16; 95% CI, -0.37 to 0.05), any other patient-reported outcomes, adverse events, or survival. Although there was more symptom reduction in the SIPC group in relation to mean change in primary outcome, the difference between the groups was not statistically significant (-0.78; 95% CI, -1.29 to -0.26 vs -0.28; 95% CI, -0.82 to 0.26; P = .14). There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367 (95% CI, -$2450 to -$282) in the SIPC group and -653 (95% CI, -$1839 to -$532) in the control group, but this difference was not statistically significant (P = .12). SIPC was perceived by patients and caregivers as building resilience, attending to function and deficits, and enabling caregivers.
Conclusions and Relevance


In this study, SIPC was not statistically significantly different from standard care for the patient-reported outcomes. However, SIPC was associated with lower cost, and in qualitative analysis was well-received by patients and caregivers, and there were no safety concerns. Further research is warranted.
Trial Registration


isrctn.org Identifier: ISRCTN18337380.",2020,There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367,"['Participants\n\n\nMulticenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services', 'Patients Severely Affected With Long-term Neurological Conditions', 'patients with long-term neurological conditions (LTNCs', '535 patients with LTNC were assessed for eligibility and 350 were randomized', 'patients with advanced cancer', 'people with LTNCs', 'Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy', 'mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n\u2009=\u2009229', '350 patients']","['SIPC (intervention, n\u2009=\u2009176) or standard care (control, n\u2009=\u2009174', 'Short-term Integrated Palliative Care', 'short-term integrated palliative care (SIPC) intervention']","['change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs', 'change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions', 'mean health and social care costs', 'symptom intensity and quality of life', 'symptom reduction', 'adverse events, or survival']","[{'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085084', 'cui_str': 'Motor neuron disease'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517604', 'cui_str': '174'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",535.0,0.243461,There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Hepgul', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Bajwah', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Crosby', 'Affiliation': 'Department of Palliative Medicine, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilcock', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lindsay', 'Affiliation': 'Marlets Hospice, Hove, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': 'Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'The Walton Centre NHS Foundation Trust and University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Groves', 'Affiliation': 'Queenscourt Hospice, Southport, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': ""Department of Palliative Care, Ashford and St Peter's Hospitals NHS Foundation Trust, Surrey, United Kingdom.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burman', 'Affiliation': ""Department of Palliative Care, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'K Ray', 'Initials': 'KR', 'LastName': 'Chaudhuri', 'Affiliation': 'Parkinson Foundation International Centre of Excellence, Kings College Hospital and Kings College London, London, United Kingdom.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Silber', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Trust, London, United Kingdom.""}, {'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.15061']
2895,32857210,Selective vs stepwise removal of deep carious lesions in primary molars: 24 months follow-up from a randomized controlled trial.,"OBJECTIVES


For well-defined deep (> 2/3 dentin extension) carious lesions, selective (SE) or stepwise (SW) carious tissue removals have been recommended, while there is limited comparative evidence for both. We compared SE and SW over 24 months in a randomized controlled trial.
METHODS


A two-arm superiority trial was conducted comparing SW/SE in primary molars without pulpal symptoms but well-defined deep lesions. Seventy-four children (1 molar/child) aged 3-9 years were recruited. In a first step, peripheral carious tissue was removed until hard dentin remained, while in proximity to the pulp, leathery dentin was left. An adhesive compomer restoration was placed and restorations re-examined after 6 months. In SW, re-entry and removal to firm dentin was conducted pulpo-proximally, followed by re-restoration. Molars were re-evaluated for a total of 24 months. Our primary outcome was success (absence of restorative/endodontic complications or pulp exposures). Secondary outcomes included total treatment and opportunity costs and restoration quality, assessed using modified USPHS criteria.
RESULTS


After 24 months, 63 molars (31 SE, 32 SW) were re-assessed. Four failures occurred (2 exposures in SW; 2 pulpal complications in SE, 1 of them leading to extraction, p > 0.05). Restoration integrity was satisfying in both groups (USPHS A/B/C in 21/8/0 SE and 23/7/0 SW, p > 0.05). Treatment and opportunity costs were significantly higher in SW than SE (mean 171 ± 51 vs. 106 ± 90; p < 0.001).
CONCLUSIONS


After 2 years, SE and SW showed similar efficacy for managing deep carious lesions in primary molars. The higher costs for SW should be considered during decision-making.
CLINICAL SIGNIFICANCE


In primary molars with well-defined deep carious lesions SE was less costly and similarly efficacious like SW. From a cost and applicability perspective, SW may need to be indicated restrictively, e.g., for very deep (> 3/4 dentin extension) lesions only.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02232828.",2020,"Treatment and opportunity costs were significantly higher in SW than SE (mean 171 ± 51 vs. 106 ± 90; p < 0.001).
","['Seventy-four children (1\xa0molar/child) aged 3-9\xa0years were recruited', 'primary molars without pulpal symptoms but well-defined deep lesions']",['SW/SE'],"['success (absence of restorative/endodontic complications or pulp exposures', 'peripheral carious tissue', 'total treatment and opportunity costs and restoration quality, assessed using modified USPHS criteria', 'opportunity costs', 'Restoration integrity']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442825', 'cui_str': 'Well defined'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",[],"[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",74.0,0.09845,"Treatment and opportunity costs were significantly higher in SW than SE (mean 171 ± 51 vs. 106 ± 90; p < 0.001).
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Elhennawy', 'Affiliation': 'Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität, and Berlin Institute of Health, Aßmannshauser Str. 4-6, 14197, Berlin, Germany. Karim.elhennawy@charite.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Finke', 'Affiliation': 'Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität, and Berlin Institute of Health, Aßmannshauser Str. 4-6, 14197, Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Paris', 'Affiliation': 'Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität, and Berlin Institute of Health, Aßmannshauser Str. 4-6, 14197, Berlin, Germany.'}, {'ForeName': 'Seif', 'Initials': 'S', 'LastName': 'Reda', 'Affiliation': 'Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität, and Berlin Institute of Health, Aßmannshauser Str. 4-6, 14197, Berlin, Germany.'}, {'ForeName': 'Paul-Georg', 'Initials': 'PG', 'LastName': 'Jost-Brinkmann', 'Affiliation': 'Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität, and Berlin Institute of Health, Aßmannshauser Str. 4-6, 14197, Berlin, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität, and Berlin Institute of Health, Aßmannshauser Str. 4-6, 14197, Berlin, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03536-6']
2896,32727433,"Nutritional status and dietary diversity of school-age children living with HIV: a cross-sectional study in Phnom Penh, Cambodia.","BACKGROUND


HIV/AIDS continues to be a major public health concern for children. Each day, worldwide, approximately 440 children became newly infected with HIV, and 270 children died from AIDS-related causes in 2018. Poor nutrition has been associated with accelerated disease progression, and sufficient dietary diversity is considered a key to improve children's nutritional status. Therefore, this study aims to 1) examine nutritional status of school-age children living with HIV in Phnom Penh, Cambodia, and 2) identify factors associated with their nutritional status, especially taking their dietary diversity into consideration.
METHODS


This cross-sectional study was conducted in May 2018 within the catchment area of the National Pediatric Hospital, Cambodia. Data from 298 children and their caregivers were included in the analyses. Using semi-structured questionnaires, face-to-face interviews were conducted to collect data regarding sociodemographic characteristics, quality of life, and dietary diversity. To assess children's nutritional status, body weight and height were measured. Viral load and duration of antiretroviral therapy (ART) were collected from clinical records. Multiple logistic regression analyses were performed to identify factors associated with stunting and wasting.
RESULTS


Of 298 children, nearly half (46.6%) were stunted, and 13.1% were wasted. The mean number of food groups consumed by the children in the past 24 h was 4.6 out of 7 groups. Factors associated with children's stunting were age (adjusted odds ratio [AOR] 2.166, 95% confidence interval [CI]: 1.151, 4.077), household wealth (AOR 0.543, 95%CI: 0.299, 0.986), duration of receiving ART (AOR 0.510, 95%CI: 0.267, 0.974), and having disease symptoms during the past 1 year (AOR 1.871, 95%CI: 1.005, 3.480). The only factor associated with wasting was being male (AOR 5.304, 95%CI: 2.210, 12.728).
CONCLUSIONS


Prevalence of stunting was more than double that of non-infected school-age children living in urban areas in Cambodia. This highlights the importance of conducting nutritional intervention programs, especially tailored for children living with HIV in the country. Although dietary diversity was not significantly associated with children's nutritional status in this study, the findings will contribute to implementing future nutritional interventions more efficiently by indicating children who are most in need of such interventions in Cambodia.",2020,"CONCLUSIONS


Prevalence of stunting was more than double that of non-infected school-age children living in urban areas in Cambodia.","['440 children became newly infected with HIV, and 270 children died from AIDS-related causes in 2018', 'May 2018 within the catchment area of the National Pediatric Hospital, Cambodia', 'children living with HIV in the country', 'school-age children living with HIV', 'school-age children living with HIV in Phnom Penh, Cambodia, and 2', 'Of 298 children, nearly half (46.6%) were stunted, and 13.1% were wasted', '298 children and their caregivers']",[],"['Nutritional status and dietary diversity', 'having disease symptoms', 'Viral load and duration of antiretroviral therapy (ART', 'duration of receiving ART', ""children's nutritional status, body weight and height""]","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",[],"[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",298.0,0.0259367,"CONCLUSIONS


Prevalence of stunting was more than double that of non-infected school-age children living in urban areas in Cambodia.","[{'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Yasuoka', 'Affiliation': 'Research and Education Center for Prevention of Global Infectious Diseases of Animals, Tokyo University of Agriculture and Technology, 3-5-8 Saiwai-cho, Fuchu-shi, Tokyo, 183-8508, Japan. jyasuoka@post.harvard.edu.'}, {'ForeName': 'Siyan', 'Initials': 'S', 'LastName': 'Yi', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore, Singapore.'}, {'ForeName': 'Sumiyo', 'Initials': 'S', 'LastName': 'Okawa', 'Affiliation': 'Cancer Control Center, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka-shi, Osaka, 541-8567, Japan.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Tuot', 'Affiliation': 'KHANA Center for Population Health Research, #33, St 71, Tonle Bassac, Chamkarmon, Phnom Penh, Cambodia.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Murayama', 'Affiliation': 'Kawasaki City Dentists Association, 2-10-10, Sunago, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Chantheany', 'Initials': 'C', 'LastName': 'Huot', 'Affiliation': 'National Pediatric Hospital, Cambodia, #100, Street 110, Teuk Laak 1 Commune, Toulkok District, Phnom Penh, Cambodia.'}, {'ForeName': 'Pheak', 'Initials': 'P', 'LastName': 'Chhoun', 'Affiliation': 'KHANA Center for Population Health Research, #33, St 71, Tonle Bassac, Chamkarmon, Phnom Penh, Cambodia.'}, {'ForeName': 'Sokunthea', 'Initials': 'S', 'LastName': 'Yem', 'Affiliation': 'KHANA Center for Population Health Research, #33, St 71, Tonle Bassac, Chamkarmon, Phnom Penh, Cambodia.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Yuzuriha', 'Affiliation': 'Graduate School of Systems Life Sciences, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'Research and Education Center for Prevention of Global Infectious Diseases of Animals, Tokyo University of Agriculture and Technology, 3-5-8 Saiwai-cho, Fuchu-shi, Tokyo, 183-8508, Japan.'}, {'ForeName': 'Kimiyo', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Graduate Education and Research Training Program in Decision Science for Sustainable Society, Kyushu University, Motooka 744, Nishi-ku, Fukuoka-shi, Fukuoka, 819-0395, Japan.'}]",BMC public health,['10.1186/s12889-020-09238-8']
2897,32860414,Catheter ablation vs. thoracoscopic surgical ablation in long-standing persistent atrial fibrillation: CASA-AF randomized controlled trial.,"AIMS


Long-standing persistent atrial fibrillation (LSPAF) is challenging to treat with suboptimal catheter ablation (CA) outcomes. Thoracoscopic surgical ablation (SA) has shown promising efficacy in atrial fibrillation (AF). This multicentre randomized controlled trial tested whether SA was superior to CA as the first interventional strategy in de novo LSPAF.
METHODS AND RESULTS


We randomized 120 LSPAF patients to SA or CA. All patients underwent predetermined lesion sets and implantable loop recorder insertion. Primary outcome was single procedure freedom from AF/atrial tachycardia (AT) ≥30 s without anti-arrhythmic drugs at 12 months. Secondary outcomes included clinical success (≥75% reduction in AF/AT burden); procedure-related serious adverse events; changes in patients' symptoms and quality-of-life scores; and cost-effectiveness. At 12 months, freedom from AF/AT was recorded in 26% (14/54) of patients in SA vs. 28% (17/60) in the CA group [OR 1.128, 95% CI (0.46-2.83), P = 0.83]. Reduction in AF/AT burden ≥75% was recorded in 67% (36/54) vs. 77% (46/60) [OR 1.13, 95% CI (0.67-4.08), P = 0.3] in SA and CA groups, respectively. Procedure-related serious adverse events within 30 days of intervention were reported in 15% (8/55) of patients in SA vs. 10% (6/60) in CA, P = 0.46. One death was reported after SA. Improvements in AF symptoms were greater following CA. Over 12 months, SA was more expensive and provided fewer quality-adjusted life-years (QALYs) compared with CA (0.78 vs. 0.85, P = 0.02).
CONCLUSION


Single procedure thoracoscopic SA is not superior to CA in treating LSPAF. Catheter ablation provided greater improvements in symptoms and accrued significantly more QALYs during follow-up than SA.
CLINICAL TRIAL REGISTRATION


ISRCTN18250790 and ClinicalTrials.gov: NCT02755688.",2020,"Over 12 months, SA was more expensive and provided fewer quality-adjusted life-years (QALYs) compared with CA (0.78 vs. 0.85, P = 0.02).
",['120 LSPAF patients to SA or CA'],"['Catheter ablation vs. thoracoscopic surgical ablation', 'SA', 'standing persistent atrial fibrillation (LSPAF', 'Catheter ablation', 'Thoracoscopic surgical ablation (SA']","['Procedure-related serious adverse events', 'single procedure freedom from AF/atrial tachycardia (AT) ≥30\u2009s without anti-arrhythmic drugs', ""clinical success (≥75% reduction in AF/AT burden); procedure-related serious adverse events; changes in patients' symptoms and quality-of-life scores; and cost-effectiveness"", 'freedom from AF/AT', 'AF symptoms']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",120.0,0.124333,"Over 12 months, SA was more expensive and provided fewer quality-adjusted life-years (QALYs) compared with CA (0.78 vs. 0.85, P = 0.02).
","[{'ForeName': 'Shouvik', 'Initials': 'S', 'LastName': 'Haldar', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Habib Rehman', 'Initials': 'HR', 'LastName': 'Khan', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, Cale Street, London SW3 6LY, UK.'}, {'ForeName': 'Vennela', 'Initials': 'V', 'LastName': 'Boyalla', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kralj-Hans', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'New York University, Langone Health, 227 East 30th Street, New York, NY 10016, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lord', 'Affiliation': 'Southampton Health Technology Assessment Centre, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Oluchukwu', 'Initials': 'O', 'LastName': 'Onyimadu', 'Affiliation': 'Southampton Health Technology Assessment Centre, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Satishkumar', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Toufan', 'Initials': 'T', 'LastName': 'Bahrami', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'De Souza', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Clague', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, Cale Street, London SW3 6LY, UK.'}, {'ForeName': 'Wajid', 'Initials': 'W', 'LastName': 'Hussain', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Jarman', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'David Gareth', 'Initials': 'DG', 'LastName': 'Jones', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Mediratta', 'Affiliation': 'Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool L14 3PE, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyde', 'Affiliation': ""Brighton and Sussex University Hospitals NHS Trust, Royal Alexandra Children's Hospital, Eastern Road, Brighton BN2 5BE, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': ""Brighton and Sussex University Hospitals NHS Trust, Royal Alexandra Children's Hospital, Eastern Road, Brighton BN2 5BE, UK.""}, {'ForeName': 'Raad', 'Initials': 'R', 'LastName': 'Mohiaddin', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Tushar V', 'Initials': 'TV', 'LastName': 'Salukhe', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Clinical Trials Unit, Kings College London, Institute of Psychiatry, 16 De Crespigny Park, London SE5 8A, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Clinical Trials Unit, Kings College London, Institute of Psychiatry, 16 De Crespigny Park, London SE5 8A, UK.'}, {'ForeName': 'Rajdeep S', 'Initials': 'RS', 'LastName': 'Khattar', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Toff', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Groby Road, Leicester LE3 9QP, UK.'}, {'ForeName': 'Vias', 'Initials': 'V', 'LastName': 'Markides', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCready', 'Affiliation': ""Brighton and Sussex University Hospitals NHS Trust, Royal Alexandra Children's Hospital, Eastern Road, Brighton BN2 5BE, UK.""}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool L14 3PE, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wong', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa658']
2898,32860422,Benefit-Risk Assessment of Esketamine Nasal Spray versus Placebo in Treatment-Resistant Depression.,"This post-hoc analysis assessed the benefit-risk profile of esketamine nasal spray+oral antidepressant (AD) induction and maintenance treatment in patients with treatment-resistant depression (TRD). The Benefit-Risk Action Team framework was utilized to assess the benefit-risk profile using data from three induction studies and one maintenance study. Benefits were proportion of remitters or responders in induction studies and proportion of stable remitters or stable responders who remained relapse-free in the maintenance study. Risks were death, suicidal ideation, most common adverse events (AEs), and potential long-term risks. Per 100 patients on esketamine+AD vs AD+placebo in induction therapy, 5-21 additional patients would remit and 14-17 additional would respond. In maintenance therapy, 19-32 fewer relapses would occur with esketamine. In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo and dizziness). These findings support a positive benefit-risk balance for esketamine+AD as induction and maintenance treatment in patients with TRD.",2020,"In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo and dizziness).","['patients with TRD', 'patients with treatment-resistant depression (TRD', 'Per 100 patients on']","['esketamine nasal spray+oral antidepressant (AD) induction and maintenance treatment', 'Esketamine Nasal Spray versus Placebo', 'esketamine+AD vs AD+placebo']","['death, suicidal ideation, most common adverse events (AEs), and potential long-term risks', 'serious or severe common AEs (primarily dissociation, vertigo and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",,0.0534257,"In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo and dizziness).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'G Katz', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Doherty', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Jaskaran', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Levitan', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2024']
2899,32860443,Daily change patterns in mindfulness and psychological health: A pilot intervention.,"OBJECTIVE


This study examined the differences in first-year college students' daily change trajectories in subjective happiness, depression, anxiety, stress, and state mindfulness.
METHOD


A 5-day, online mindfulness-based intervention (MI) condition and stress management (SM) condition were employed in 247 first-year college students.
RESULTS


Students in both the MI and SM conditions displayed similar significant linear declines in anxiety and stress, but there were significant differences between the two conditions, including: (1) the MI condition showing a significant linear increase in subjective happiness compared with no change in the SM condition and (2) the SM condition showed a significant linear decrease in depression compared to no significant change in the MI condition.
CONCLUSION


Brief online interventions-whether MI or SM-can promote better mental health and reduce psychological distress. The results also lend support for MI's differential influence on first-year college students' happiness and SM's differential influence on their depression.",2020,"RESULTS


Students in both the MI and SM conditions displayed similar significant linear declines in anxiety and stress, but there were significant differences between the two conditions, including: (1) the MI condition showing a significant linear increase in subjective happiness compared with no change in the SM condition and (2) the SM condition showed a significant linear decrease in depression compared to no significant change in the MI condition.
",['247 first-year college students'],['online mindfulness-based intervention'],"['anxiety and stress', 'MI condition', 'MI) condition and stress management (SM) condition', 'subjective happiness, depression, anxiety, stress, and state mindfulness', 'subjective happiness', 'depression']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0138129,"RESULTS


Students in both the MI and SM conditions displayed similar significant linear declines in anxiety and stress, but there were significant differences between the two conditions, including: (1) the MI condition showing a significant linear increase in subjective happiness compared with no change in the SM condition and (2) the SM condition showed a significant linear decrease in depression compared to no significant change in the MI condition.
","[{'ForeName': 'Shin Ye', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Psychological Sciences, Texas Tech University, Lubbock, Texas, USA.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Suh', 'Affiliation': 'Psychology and Child & Human Development Academic Group, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Wonjung', 'Initials': 'W', 'LastName': 'Oh', 'Affiliation': 'Department of Psychological Sciences, Texas Tech University, Lubbock, Texas, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Daheim', 'Affiliation': 'Department of Psychological Sciences, Texas Tech University, Lubbock, Texas, USA.'}]",Journal of clinical psychology,['10.1002/jclp.23043']
2900,32860466,Psychosocial outcomes of a pilot study of work-tailored cognitive behavioral therapy intervention for adults with serious mental illness.,"OBJECTIVE


Many people with serious mental illness (SMI) continue to struggle with work functioning despite the receipt of supported employment (SE) services. In response, adjunctive interventions to SE have begun to be developed. One such approach, the cognitive behavioral therapy for work success (CBTw) intervention, targets cognitive and behavioral barriers to competitive work success in adults with SMI. Using a pre-post design, this pilot study examined the psychosocial outcomes of the CBTw program in 52 adults with SMI receiving SE.
METHOD


Recovery attitudes, work-related self-efficacy, self-esteem, and symptom domains (depression, anxiety, psychosis) were measured at baseline and after the 12-week intervention. Paired samples t-tests examined changes in outcomes over time.
RESULTS


At posttreatment, participants had significant improvements in recovery attitudes, self-esteem, depressive, and negative symptoms. Other psychosocial outcomes did not significantly change.
CONCLUSIONS


This pilot work demonstrates CBTw is a promising intervention to improve recovery and wellness in SMI.",2020,"At posttreatment, participants had significant improvements in recovery attitudes, self-esteem, depressive, and negative symptoms.","['adults with SMI', 'adults with serious mental illness', '52 adults with SMI receiving SE', 'people with serious mental illness']","['CBTw', 'work-tailored cognitive behavioral therapy intervention', 'CBTw program', 'cognitive behavioral therapy']","['recovery attitudes, self-esteem, depressive, and negative symptoms', 'self-efficacy, self-esteem, and symptom domains (depression, anxiety, psychosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",52.0,0.0321451,"At posttreatment, participants had significant improvements in recovery attitudes, self-esteem, depressive, and negative symptoms.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Kukla', 'Affiliation': 'HSR&D Center for Health Information and Communication, Richard L. Roudebush VA Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Strasburger', 'Affiliation': 'Richard L. Roudebush VA Medical Center, Psychiatry Service, Indianapolis, Indiana, USA.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Salyers', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, Indiana, USA.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Rollins', 'Affiliation': 'HSR&D Center for Health Information and Communication, Richard L. Roudebush VA Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lysaker', 'Affiliation': 'Richard L. Roudebush VA Medical Center, Psychiatry Service, Indianapolis, Indiana, USA.'}]",Journal of clinical psychology,['10.1002/jclp.23048']
2901,32860470,A stochastically curtailed two-arm randomised phase II trial design for binary outcomes.,"Randomised controlled trials are considered the gold standard in trial design. However, phase II oncology trials with a binary outcome are often single-arm. Although a number of reasons exist for choosing a single-arm trial, the primary reason is that single-arm designs require fewer participants than their randomised equivalents. Therefore, the development of novel methodology that makes randomised designs more efficient is of value to the trials community. This article introduces a randomised two-arm binary outcome trial design that includes stochastic curtailment (SC), allowing for the possibility of stopping a trial before the final conclusions are known with certainty. In addition to SC, the proposed design involves the use of a randomised block design, which allows investigators to control the number of interim analyses. This approach is compared with existing designs that also use early stopping, through the use of a loss function comprised of a weighted sum of design characteristics. Comparisons are also made using an example from a real trial. The comparisons show that for many possible loss functions, the proposed design is superior to existing designs. Further, the proposed design may be more practical, by allowing a flexible number of interim analyses. One existing design produces superior design realisations when the anticipated response rate is low. However, when using this design, the probability of rejecting the null hypothesis is sensitive to misspecification of the null response rate. Therefore, when considering randomised designs in phase II, we recommend the proposed approach be preferred over other sequential designs.",2020,"The comparisons show that for many possible loss functions, the proposed design is superior to existing designs.",[],['stochastic curtailment (SC'],[],[],[],[],,0.159279,"The comparisons show that for many possible loss functions, the proposed design is superior to existing designs.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Hub for Trials Methodology Research, Medical Research Council Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Grayling', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Mander', 'Affiliation': 'College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}]",Pharmaceutical statistics,['10.1002/pst.2067']
2902,32861015,Cognitive behavioral therapy for insomnia in restless legs syndrome patients.,"OBJECTIVES


The purpose of this study was to investigate the effects of cognitive behavioral therapy for insomnia (CBTI) in patients with Restless Legs Syndrome (RLS).
METHODS


This is a randomized controlled study. The patients were sequentially selected and randomly assigned to either a CBTI group or a non-CBTI group. A total of 25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center. Twelve were assigned to the CBTI group, and 13 were assigned to the non-CBTI group. The CBTI group received 4 sessions of behavioral therapy, while the non-CBTI group received one informative session on sleep hygiene. All patients completed sleep and psychiatric-related questionnaires. In addition, each individual completed a one-week sleep log for collecting subjective sleep data and actigraphy for objective sleep data.
RESULTS


After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group. The effect of CBTI on sleep-related data was maintained for up to three months.
CONCLUSIONS


CBTI was effective in RLS patients by improving sleep quality and anxiety symptoms. CBTI may be considered in clinical practice for RLS patients with comorbid insomnia.",2020,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","['restless legs syndrome patients', 'patients with Restless Legs Syndrome (RLS', 'RLS patients with comorbid insomnia', '25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center']","['CBTI', 'CBTI group or a non-CBTI', 'cognitive behavioral therapy', 'Cognitive behavioral therapy']","['sleep quality and anxiety symptoms', 'severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety']","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",25.0,0.0273384,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","[{'ForeName': 'Mei Ling', 'Initials': 'ML', 'LastName': 'Song', 'Affiliation': 'College of Nursing, Daegu Health College, Daegu, South Korea; College of Nursing, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Kyung Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea. Electronic address: kmp@kmu.ac.kr.'}, {'ForeName': 'Gholam K', 'Initials': 'GK', 'LastName': 'Motamedi', 'Affiliation': 'Department of Neurology, Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yong Won', 'Initials': 'YW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Keimyung University, School of Medicine, Daegu, South Korea. Electronic address: neurocho@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.07.011']
2903,32861189,Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy.,"OBJECTIVE/BACKGROUND


Clinical recommendations include putting infants to bed using a consistent bedtime routine at an appropriate hour to promote longer nighttime sleep. Actigraphy was used in this exploratory study to examine how bedtime routines and nighttime sleep onset were associated with nighttime total sleep time (TST) and efficiency from 6 to 24 weeks of age.
PATIENTS/METHODS


Infants (n = 24) wore sleep actigraphs for three, one-week periods at 6, 15, and 24 weeks of age. Nighttime TST, sleep efficiency, sleep onset and offset were quantified. Mothers reported on infant bedtime routines using the Brief Infant Sleep Questionnaire at each age. Multilevel models examined between- and within-person associations.
RESULTS


As infants aged, sleep onset was earlier, and bedtime routines became shorter (p's < 0.05). Infants fell asleep between 7 and 8:00PM on 24% of the nights. Most mothers (70%) reported that they often fed infants to sleep for the night. For every 1 h earlier in infants' usual sleep onset, nighttime TST was 34.4 min longer that night (p < 0.01). Infants with earlier than usual sleep onset had slightly earlier sleep offset the next morning (8.4 min for every 1 h earlier in onset; p = 0.02). Between-person analyses showed similar patterns. Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
CONCLUSION


Infants who fell asleep earlier also slept longer at night. Keeping infants up later in hopes of them sleeping in longer may be counterproductive.",2020,"Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
",['Infants (n\xa0'],[],"['Nighttime TST, sleep efficiency, sleep onset and offset', 'Time for bed', 'sleep onset, nighttime TST', 'Infants fell asleep', 'nighttime total sleep time (TST) and efficiency', 'sleep actigraphs', 'nighttime sleep duration', 'longer nighttime TST']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",,0.041887,"Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Adams', 'Affiliation': 'Center for Childhood Obesity Research, Penn State University, University Park, PA, United States; Department of Nutritional Sciences, Penn State University, University Park, PA, United States. Electronic address: elizabeth.adams@vcuhealth.org.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, Penn State University, University Park, PA, United States; Department of Nutritional Sciences, Penn State University, University Park, PA, United States. Electronic address: jfs195@psu.edu.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Master', 'Affiliation': 'Department of Biobehavioral Health, Penn State University, University Park, PA, United States. Electronic address: lindsay.master@gmail.com.'}, {'ForeName': 'Orfeu M', 'Initials': 'OM', 'LastName': 'Buxton', 'Affiliation': ""Department of Biobehavioral Health, Penn State University, University Park, PA, United States; Division of Sleep Medicine, Harvard Medical School, Boston, MA, United States; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: orfeu@psu.edu.""}]",Sleep medicine,['10.1016/j.sleep.2020.07.003']
2904,32861197,"Gut mycobiome and its interaction with diet, gut bacteria and alzheimer's disease markers in subjects with mild cognitive impairment: A pilot study.","BACKGROUND


Recently, we reported that patients with mild cognitive impairment (MCI) harbor specific signature of bacteria in their gut and that a modified Mediterranean ketogenic diet (MMKD) improves Alzheimer's disease (AD) markers in cerebrospinal fluid (CSF) and the signatures of gut bacteria. However, other microbial population such as gut fungi (mycobiome) in relation to MCI/AD pathology, gut bacteria and diet remain unknown.
METHODS


We measure gut mycobiome by sequencing of the fungal rRNA ITS1 gene in 17 older adults (11 MCI; 6 cognitively normal [CN]) in a single-center, randomized, double-blind, crossover pilot study, before and after 6 weeks intervention of MMKD and American Heart Association Diet (AHAD), and determine its correlation with AD markers in CSF and gut bacteria.
FINDINGS


Compared to CN counterparts, patients with MCI have higher proportion of families Sclerotiniaceae, Phaffomyceteceae, Trichocomaceae, Cystofilobasidiaceae, Togniniaceae and genera Botrytis, Kazachstania, Phaeoacremonium and Cladosporium and lower abundance of Meyerozyma. Specific fungal taxa exhibit distinct correlation arrays with AD markers and gut bacteria in subjects with versus without MCI. MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
INTERPRETATION


The study reveals MCI-specific mycobiome signatures and demonstrates that distinct diets modulate the mycobiome in association with AD markers and fungal-bacterial co-regulation networks in patients with MCI. The findings corroborate the notion of considering gut mycobiome as a unique factor that can affect cognitive health/AD by interacting with gut bacteria and diet and facilitate better understanding of the AD and related microbiome, using unique diet or microbiome modulators.",2020,"MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
","['subjects with versus without MCI', 'subjects with mild cognitive impairment', 'patients with mild cognitive impairment (MCI', 'patients with MCI', '17 older adults (11 MCI; 6 cognitively normal [CN']","['Mediterranean ketogenic diet (MMKD', 'MMKD and American Heart Association Diet (AHAD']","['families Sclerotiniaceae, Phaffomyceteceae, Trichocomaceae, Cystofilobasidiaceae, Togniniaceae and genera Botrytis, Kazachstania, Phaeoacremonium and Cladosporium and lower abundance of Meyerozyma']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1002379', 'cui_str': 'Sclerotiniaceae'}, {'cui': 'C1002104', 'cui_str': 'Trichocomaceae'}, {'cui': 'C0006040', 'cui_str': 'Botrytis'}, {'cui': 'C1085204', 'cui_str': 'Kazachstania'}, {'cui': 'C1025333', 'cui_str': 'Phaeoacremonium'}, {'cui': 'C0008886', 'cui_str': 'Cladosporium'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3008845', 'cui_str': 'Meyerozyma'}]",17.0,0.0319494,"MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
","[{'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Nagpal', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Neth', 'Affiliation': 'Department of Internal Medicine- Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Neurology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Sidharth P', 'Initials': 'SP', 'LastName': 'Mishra', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Department of Internal Medicine- Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States. Electronic address: suzcraft@wakehealth.edu.'}, {'ForeName': 'Hariom', 'Initials': 'H', 'LastName': 'Yadav', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States. Electronic address: hyadav@wakehealth.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102950']
2905,32621587,Paediatric population pharmacokinetic modelling to assess hydrocortisone replacement dosing regimens in young children.,"Context


Accurate hydrocortisone dosing in children with adrenal insufficiency is important to avoid the risks of over and under treatment including iatrogenic Cushing's syndrome and adrenal crisis.
Objective


To establish a population pharmacokinetic model of hydrocortisone in children and use this to refine hydrocortisone replacement regimens.
Design and methods


Pharmacokinetic study of hydrocortisone granules, available in 0.5, 1, 2 and 5 mg dose strengths, in 24 children with adrenal insufficiency aged 2 weeks to 6 years. Cortisol concentrations quantified by LC-MS/MS were used to refine an adult pharmacokinetic model to a paediatric population model which was then used to simulate seven different hydrocortisone treatment regimens.
Results


Pre-dose cortisol levels were undetectable in 54% of the 24 children. The developed pharmacokinetic model had good predictive performance. Simulations for the seven treatment regimens using either three- or four-times daily dosing showed treatment regimens delivered an AUC0-24h within the 90% reference range for healthy children except in neonates where two regimens had an AUC below the 5th percentile. Cortisol concentrations at individual time points in the 24 h were outside the 90% reference range for healthy individuals in 50%, 55-65% and 70-75% for children, infants and neonates, respectively, with low cortisol levels being most prevalent.
Conclusions


Current paediatric hydrocortisone treatment regimens based on either three- or four-times daily administration replicate cortisol exposure based on AUC0-24h, but the majority of cortisol levels are above or below physiological cortisol levels with low levels very common before the next dose.",2020,"Cortisol concentrations at individual time points in the 24 h were outside the 90% reference range for healthy individuals in 50%, 55-65% and 70-75% for children, infants and neonates, respectively, with low cortisol levels being most prevalent.
","['24 children with adrenal insufficiency aged 2 weeks to 6 years', 'young children', 'children with adrenal insufficiency']","['hydrocortisone granules', 'hydrocortisone replacement', 'hydrocortisone']","['Results\n\n\nPre-dose cortisol levels', 'Cortisol concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",24.0,0.0448995,"Cortisol concentrations at individual time points in the 24 h were outside the 90% reference range for healthy individuals in 50%, 55-65% and 70-75% for children, infants and neonates, respectively, with low cortisol levels being most prevalent.
","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Michelet', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Melin', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, Germany.'}, {'ForeName': 'Zinnia P', 'Initials': 'ZP', 'LastName': 'Parra-Guillen', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Neumann', 'Affiliation': 'Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'J Martin', 'Initials': 'JM', 'LastName': 'Whitaker', 'Affiliation': 'Diurnal Limited, Cardiff, UK.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Stachanow', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Huisinga', 'Affiliation': 'Institute of Mathematics, Universität Potsdam, Potsdam, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Diurnal Limited, Cardiff, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Blankenstein', 'Affiliation': 'Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ross', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kloft', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, Germany.'}]",European journal of endocrinology,['10.1530/EJE-20-0231']
2906,32860568,RE: Renal protective effect of N-acetylcysteine with stepwise ramping voltage against extracorporeal shock wave lithotripsy-induced renal injury: a prospective randomized trial from Desoky et al.,,2020,,['induced renal injury'],['N-acetylcysteine with stepwise ramping voltage against extracorporeal shock wave lithotripsy'],[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}]",[],,0.0167101,,"[{'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Sighinolfi', 'Affiliation': 'Department of Urology, University of Modena and Reggio Emilia, Via del Pozzo 71, 41100, Modena, Italy. sighinolfic@yahoo.com.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Rocco', 'Affiliation': 'Department of Urology, University of Modena and Reggio Emilia, Via del Pozzo 71, 41100, Modena, Italy.'}]",International urology and nephrology,['10.1007/s11255-020-02617-5']
2907,32857590,Weight Gain Induced by Continuous Positive Airway Pressure in Patients with Obstructive Sleep Apnea is Mediated by Fluid Accumulation: A Randomized Cross-Over Controlled Trial.,,2020,,['Patients with Obstructive Sleep Apnea'],['Weight Gain Induced by Continuous Positive Airway Pressure'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]",[],,0.0281516,,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Herculano', 'Affiliation': 'University of Sao Paulo, 28133, Sao Paulo, Brazil.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Grad', 'Affiliation': 'Heart Institute (InCor), Hospital das Clinicas, University of São Paulo School of Medicine, Pulmonary Division, São Paulo, Brazil.'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': 'Heart Institute (InCor) University of São Paulo Medical School, Brazil, Hypertension Unit, São Paulo, Brazil.'}, {'ForeName': 'André L P', 'Initials': 'ALP', 'LastName': 'de Albuquerque', 'Affiliation': 'Heart Institute (InCor), University of Sao Paulo Medical School, Pulmonary Division, São Paulo, Brazil.'}, {'ForeName': 'Camila M', 'Initials': 'CM', 'LastName': 'Melo', 'Affiliation': 'Universidade Federal de Sao Paulo, 28105, Sao Paulo, Brazil.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'School of Medicine, University of São Paulo, Sleep Laboratory, Sao Paulo, Brazil.'}, {'ForeName': 'Pedro R', 'Initials': 'PR', 'LastName': 'Genta', 'Affiliation': 'Heart Institute (InCor), Hospital das Clinicas, University of São Paulo School of Medicine, Pulmonary Division, São Paulo, Brazil; prgenta@gmail.com.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202005-1853LE']
2908,32857610,Impact of a Gardening and Physical Activity Intervention in Title 1 Schools: The TGEG Study.,"Background:  The purpose of the Texas!Grow!Eat!Go! (TGEG) study was to assess individual and combined effects of school-based gardening and physical activity (PA) interventions on children's eating and PA behaviors and obesity status.  Methods:  Using a 2 × 2 design, 28 low-income schools in Texas were randomized to 1 of 4 conditions: (1) School Garden intervention (Learn!Grow!Eat!Go! [LGEG]), (2) PA intervention (Walk Across Texas [WAT!]), (3) both Garden and PA intervention ( Combined ), or (4) neither Garden nor PA intervention ( Control ). Participants included 1326 third grade students and parents (42% Hispanic; 78% free/reduced lunch). Student and parent data were collected at the beginning and end of the school year. Two different sets of analyses measuring pre-post changes in outcomes within and across conditions were estimated by factorial ANOVAs using mixed models adjusted for demographics.  Results:  Main effect analyses indicate that relative to children at schools that did not receive LGEG, children at schools that received LGEG, either individually or in combination with WAT!, showed significant increases in Nutrition knowledge, Vegetable preference, and Vegetable tasted ( p  < 0.001 in all cases). Within-group analyses show that compared to Comparison, children in the WAT! group significantly increased in the amount of time parents and children were active together ( p  = 0.038). In addition, children in LGEG and WAT! schools significantly decreased BMI percentile ( p  = 0.042,  p  = 0.039, respectively), relative to children in Comparison schools.  Conclusions:  Both the garden and PA interventions independently produced significant changes related to healthy lifestyle behaviors. However, combining the two interventions did not show greater impact than the single interventions, underscoring the need for more research to determine how to better implement comprehensive interventions at schools.",2020,"schools significantly decreased BMI percentile ( p  = 0.042,  p  = 0.039, respectively), relative to children in Comparison schools.  ","['28 low-income schools in Texas', ""children's eating and PA behaviors and obesity status"", 'Title 1 Schools', 'Participants included 1326 third grade students and parents (42% Hispanic; 78% free/reduced lunch']","['school-based gardening and physical activity (PA) interventions', 'LGEG', 'Gardening and Physical Activity Intervention', 'School Garden intervention (Learn!Grow!Eat!Go! [LGEG]), (2) PA intervention (Walk Across Texas [WAT!]), (3) both Garden and PA intervention ( Combined ), or (4) neither Garden nor PA intervention ( Control ', 'Texas!Grow!Eat!Go']","['healthy lifestyle behaviors', 'BMI percentile', 'amount of time parents', 'Nutrition knowledge, Vegetable preference, and Vegetable tasted']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}]",,0.0212239,"schools significantly decreased BMI percentile ( p  = 0.042,  p  = 0.039, respectively), relative to children in Comparison schools.  ","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'van den Berg', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center (UTHealth) School of Public Health, Austin, TX, USA.'}, {'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Warren', 'Affiliation': 'Family Development & Resource Management, Youth Gardening, Texas A&M AgriLife Extension Service, College Station, TX, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McIntosh', 'Affiliation': 'Recreation, Park and Tourism Sciences and Sociology, Transdisciplinary Center for Health Equity Research, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Hoelscher', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center (UTHealth) School of Public Health, Austin, TX, USA.'}, {'ForeName': 'Marcia G', 'Initials': 'MG', 'LastName': 'Ory', 'Affiliation': 'Health Promotion and Community Health Sciences, Texas A&M Health Science Center School of Public Health, College Station, TX, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Jovanovic', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center (UTHealth) School of Public Health, Austin, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lopez', 'Affiliation': 'Family Development & Resource Management, Youth Gardening, Texas A&M AgriLife Extension Service, College Station, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Whittlesey', 'Affiliation': 'Department of Horticultural Sciences, Youth Gardening, Texas A&M AgriLife Extension Service, College Station, TX, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Family Development & Resource Management, Youth Gardening, Texas A&M AgriLife Extension Service, College Station, TX, USA.'}, {'ForeName': 'Caren', 'Initials': 'C', 'LastName': 'Walton', 'Affiliation': 'Junior Master Gardener Program, Youth Gardening, Texas A&M AgriLife Extension Service, College Station, TX, USA.'}, {'ForeName': 'Lisako', 'Initials': 'L', 'LastName': 'McKyer', 'Affiliation': 'College of Education and Human Development, Transdisciplinary Center for Health Equity Research, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Ranjit', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center (UTHealth) School of Public Health, Austin, TX, USA.'}]",Childhood obesity (Print),['10.1089/chi.2019.0238']
2909,32857616,Four weeks of vitamin D supplementation improves nitric oxide-mediated microvascular function in college-aged African Americans.,"Nitric oxide (NO)-mediated endothelial dysfunction, secondary to increased oxidative stress, presents in young African American (AA) compared to European American (EA) adults, and may be modulated by vitamin D status. We assessed cutaneous microvascular function in 18 young, healthy (21±2 yr; 9 M, 9 F) subjects before (pre: 8 AA, 10 EA) and 13 subjects after (post: 7 AA, 6 EA) four weeks of 2,000 IU/day oral vitamin D supplementation. Serum vitamin D concentrations [25(OH)D] were measured at each visit. Three intradermal microdialysis fibers placed in the ventral forearm were randomized for treatment with 10 μM tempol, 100 μM apocynin, or lactated Ringer's (control). Local heating (39˚C) induced cutaneous vasodilation; red cell flux was measured at each site (laser-Doppler flowmetry) and cutaneous vascular conductance (CVC=flux/MAP) was expressed as a percentage of maximum (28mM sodium nitroprusside+43°C) for each phase of the local heating response. After attaining stable elevated blood flow, 15mM N G -nitro-L-arginine methyl ester (L-NAME; NO synthase inhibitor) was perfused at all sites to quantify the NO contribution to cutaneous vasodilation (%NO), calculated as the difference between local heating and L-NAME plateaus. Serum [25(OH)D], the magnitude of the local heating response, and %NO were all lower in AA versus EA (p<0.01). Tempol (p=0.01), but not apocynin (p≥0.19), improved the local heating response and %NO. Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AA (p≤0.04), but not EA (p≥0.41). Vitamin D supplementation mitigated endothelial dysfunction, an antecedent to overt CVD, in otherwise healthy, young AA adults.",2020,"Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AA (p≤0.04), but not EA (p≥0.41).","['college-aged African Americans', 'young African American (AA) compared to European American (EA) adults', '18 young, healthy (21±2 yr; 9 M, 9 F) subjects before (pre: 8 AA, 10 EA) and 13 subjects after (post: 7 AA, 6 EA) four weeks of 2,000']","['vitamin D supplementation', 'IU/day oral vitamin D supplementation', ""10 μM tempol, 100 μM apocynin, or lactated Ringer's (control"", 'Vitamin D supplementation']","['Serum vitamin D concentrations [25(OH)D', 'nitric oxide-mediated microvascular function', 'Serum [25(OH)D], the magnitude of the local heating response', 'serum [25(OH)D], the local heating response, and %NO in AA', 'cutaneous microvascular function', 'endothelial dysfunction', 'cutaneous vascular conductance (CVC=flux/MAP', 'Local heating (39˚C) induced cutaneous vasodilation; red cell flux', 'local heating response']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0045283', 'cui_str': 'tempol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0050465', 'cui_str': 'acetovanillone'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]",,0.051069,"Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AA (p≤0.04), but not EA (p≥0.41).","[{'ForeName': 'S Tony', 'Initials': 'ST', 'LastName': 'Wolf', 'Affiliation': 'Kinesiology, Pennsylvania State University, United States.'}, {'ForeName': 'Nina G', 'Initials': 'NG', 'LastName': 'Jablonski', 'Affiliation': 'Anthropology, Pennsylvania State University, United States.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Ferguson', 'Affiliation': 'Dermatology, Penn State Hershey Medical Group.'}, {'ForeName': 'Lacy M', 'Initials': 'LM', 'LastName': 'Alexander', 'Affiliation': 'Kinesiology, Pennsylvania State University, United States.'}, {'ForeName': 'W Larry', 'Initials': 'WL', 'LastName': 'Kenney', 'Affiliation': 'Kinesiology, Pennsylvania State University, United States.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00631.2020']
2910,32857643,Evaluation of a Discussion Guide to Promote Patient Understanding of Menopause and Informed Treatment Decision-Making.,"Background:  Patient-provider communication surrounding menopause symptoms and treatment is often limited. We developed and evaluated a health literacy-appropriate discussion guide to support patient education.  Materials and Methods:  A cross-sectional randomized study was conducted among 100 English-speaking women, aged 45-60 years, in Chicago, IL, and Durham, NC. Participants were randomly assigned to review either the discussion guide or a standard education material ( n  = 50 per arm) and to complete an open book knowledge questionnaire; they then rated the appearance and quality of both materials. Bivariate analyses examined knowledge and satisfaction by study arm and across sociodemographic characteristics. Multivariable models tested the effectiveness of the discussion guide to improve knowledge compared with the standard material.  Results:  Women receiving the discussion guide demonstrated significantly higher knowledge scores compared with those who reviewed the standard material (mean [ M ] = 20.0, standard deviation [SD] = 2.7, vs.  M  = 18.1, SD = 2.6;  p  < 0.001); 82.0% of those exposed to the discussion guide correctly answered ≥85% of knowledge items compared with only 48.0% of those reviewing the standard material ( p  < 0.001). In multivariable analyses, participants receiving the discussion guide displayed significantly greater knowledge in comparison with those receiving the standard material regardless of whether knowledge was examined as a score ( ∝  = 1.9, 95% confidence interval [CI]: 0.9-2.9,  p  < 0.001) or 85% threshold (odds ratio: 5.7, 95% CI: 2.0-16.2,  p  < 0.001). More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content.  Conclusions:  The discussion guide improved understanding of menopause symptoms and treatment options in comparison with a current standard and was well received by a diverse audience.",2020,More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content.  ,"['100 English-speaking women, aged 45-60 years, in Chicago, IL, and Durham, NC']",['discussion guide or a standard education material ( n \u2009=\u200950 per arm) and to complete an open book knowledge questionnaire'],['knowledge scores'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0454851', 'cui_str': 'Durham'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0698567,More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content.  ,"[{'ForeName': 'Stacy Cooper', 'Initials': 'SC', 'LastName': 'Bailey', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Emma N', 'Initials': 'EN', 'LastName': 'Andrews', 'Affiliation': 'US/Global Medical Affairs, Pfizer, Inc., New York, New York, USA.'}, {'ForeName': 'Candida C', 'Initials': 'CC', 'LastName': 'Halton', 'Affiliation': 'School of Social Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2020.8436']
2911,32857730,Effects of Acupressure Applied to P6 Point on Nausea Vomiting in Pregnancy: A Double-Blind Randomized Controlled.,"Background


Two-thirds of pregnant women experience nausea and vomiting during early pregnancy. The use of pharmacological drugs to alleviate this condition does not reduce nausea and vomiting to the desired extent.
Primary Study Objective


The present study was conducted to investigate the effects of acupressure applied to Nei-guan (P6) point on nausea and vomiting in pregnancy.
Methods


This study was designed as a double-blind randomized controlled trial.
Setting


This study data was collected at a Private Hospital.
Participants


Turkish women with a singleton pregnancy at the gestation of 6-11 weeks were recruited. One hundred forty-nine women were randomized into the acupressure and control groups.
Intervention


While the women in the acupressure group applied acupressure point on both wrists 3 times a day for 1 week, the women in the control group performed no intervention.
Primary Outcome Measures


The participants' pre- and post-procedure nausea-vomiting status was assessed using the Nausea and Vomiting in Pregnancy Instrument.
Results


In the present study, acupressure applied to the participants in the acupressure group very significantly reduced nausea and vomiting (Before intervention 7 vs. After intervention 4) compared to the control group (Before intervention 7 vs. After intervention 8, P < .001).
Conclusions


Statistical results have provided that acupressure taught to women was found to be highly effective in reducing pregnancy-induced nausea and vomiting. Teaching pregnant women how to perform acupressure on their own will be an alternative method especially for women who do not want to use pharmacological methods in the first trimester of their pregnancy.",2020,"In the present study, acupressure applied to the participants in the acupressure group very significantly reduced nausea and vomiting (Before intervention 7 vs. After intervention 4) compared to the control group (Before intervention 7 vs. After intervention 8, P < .001).
","['pregnant women experience nausea and vomiting during early pregnancy', 'in Pregnancy', 'Participants\n\n\nTurkish women with a singleton pregnancy at the gestation of 6-11 weeks were recruited', 'Teaching pregnant women', 'One hundred forty-nine women']","['Acupressure', 'acupressure', 'acupressure and control groups', 'acupressure applied to Nei-guan (P6']","['pregnancy-induced nausea and vomiting', 'Nausea and Vomiting in Pregnancy Instrument', 'Nausea Vomiting', 'nausea and vomiting']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0325602', 'cui_str': 'Guan'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",149.0,0.100975,"In the present study, acupressure applied to the participants in the acupressure group very significantly reduced nausea and vomiting (Before intervention 7 vs. After intervention 4) compared to the control group (Before intervention 7 vs. After intervention 8, P < .001).
","[{'ForeName': 'Ayça', 'Initials': 'A', 'LastName': 'Solt Kirca', 'Affiliation': ''}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kanza Gul', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2912,32857732,Multi-walled carbon nanotubes functionalized with pyrene-PEG via π-π interactions: toxicological assessment in zebrafish embryos.,"Multi-walled carbon nanotubes (MWCNT) have many promising biological applications, even though functionalization is needed for better biocompatibility. Functionalization of MWCNT with polyethylene glycol (PEG) is a promising and widely studied approach, but the best PEGylation method is still under investigation. In this work, we have tested the biological implications of MWCNT functionalized via π-stacking with pyrene-PEG (MWCNT-Pyr-PEG) in zebrafish embryos. As Pyr toxicity is well documented and represents a major concern for the safety of the proposed approach, we have also tested the effects of the exposure to the isolated conjugate (Pyr-PEG). The resulting suspensions were stable in saline medium and well dispersed. Zebrafish embryos at 24 h post-fertilization (hpf) were dechorionated and randomly assigned to seven experimental groups (n = 50 per group): control, MWCNT-Pyr-PEG at 0.2, 2.0, and 20.0 mg l -1 , and Pyr-PEG at the same concentrations, and exposures were performed in 96-well plates. Specimens were observed for heart rate, malformations, body length, mortality, traveled distance, and number of new movements. Heart rate was reduced in embryos exposed to any tested concentration of MWCNT-Pyr-PEG, while this effect was observed with Pyr-PEG from 2 mg l -1 . The highest concentration of MWCNT-Pyr-PEG also led to increased occurrence of malformations, shortened body length and reduced traveled distance. The functionalization approach shows promise due to the stability in saline media, even though toxic effects were observed in the highest tested concentrations, being the MWCNT the main actors underlying these outcomes.",2020,"Heart rate was reduced in embryos exposed to any tested concentration of MWCNT-Pyr-PEG, while this effect was observed with Pyr-PEG from 2 mg l -1 .",['zebrafish embryos'],"['MWCNT with polyethylene glycol (PEG', 'Multi-walled carbon nanotubes (MWCNT', 'control, MWCNT-Pyr-PEG']","['heart rate, malformations, body length, mortality, traveled distance, and number of new movements', 'Heart rate', 'occurrence of malformations, shortened body length and reduced traveled distance', 'toxic effects']","[{'cui': 'C0043457', 'cui_str': 'Zebrafishes'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1138408', 'cui_str': 'Carbon Nanotubes'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0305508,"Heart rate was reduced in embryos exposed to any tested concentration of MWCNT-Pyr-PEG, while this effect was observed with Pyr-PEG from 2 mg l -1 .","[{'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Cordeiro', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Saúde (PPGBS), Universidade do Oeste de Santa Catarina (UNOESC), Joaçaba, SC, Brazil. Programa de Pós-Graduação em Ciências Fisiológicas (PPGCF), Universidade Federal do Rio Grande (FURG), Rio Grande, RS, Brazil.'}, {'ForeName': 'Lívia S', 'Initials': 'LS', 'LastName': 'Gomides', 'Affiliation': ''}, {'ForeName': 'Camila O', 'Initials': 'CO', 'LastName': 'Vian', 'Affiliation': ''}, {'ForeName': 'Marina T', 'Initials': 'MT', 'LastName': 'Carboni', 'Affiliation': ''}, {'ForeName': 'Adelina P', 'Initials': 'AP', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Gisele Eva', 'Initials': 'GE', 'LastName': 'Bruch', 'Affiliation': ''}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Barros', 'Affiliation': ''}]",Nanotechnology,['10.1088/1361-6528/abae2f']
2913,32857785,The reimagination of school-based physical activity research in the COVID-19 era.,"Deirdre Harrington and Michelle O'Reilly discuss the article ""Effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among UK adolescents: A cluster randomised controlled trial"" by Kirsten Corder and colleagues.",2020,"Deirdre Harrington and Michelle O'Reilly discuss the article ""Effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among UK adolescents: A cluster randomised controlled trial"" by Kirsten Corder and colleagues.",['UK adolescents'],['GoActive intervention'],['physical activity'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0382978,"Deirdre Harrington and Michelle O'Reilly discuss the article ""Effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among UK adolescents: A cluster randomised controlled trial"" by Kirsten Corder and colleagues.","[{'ForeName': 'Deirdre M', 'Initials': 'DM', 'LastName': 'Harrington', 'Affiliation': 'Lecturer in Physical Activity, Sedentary Behaviour and Health, Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': ""O'Reilly"", 'Affiliation': 'Associate Professor of Communication in Mental Health, School of Media, Communication and Sociology and School of Psychology, University of Leicester, Leicester, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003267']
2914,32857839,Inferences about drug safety in phase 3 trials in oncology: Examples from advanced prostate cancer.,"BACKGROUND


Safety is a central consideration when choosing between multiple medications with similar efficacy. We aimed to evaluate whether adverse event (AE) profiles of three such drugs in advanced prostate cancer could be distinguished based on published literature.
METHODS


We assessed consistency in AE reporting, AE risk in placebo arms, and methodology used for risk estimates and quantification of statistical uncertainty in randomized placebo-controlled phase 3 trials of apalutamide, enzalutamide and darolutamide in advanced prostate cancer.
RESULTS


Seven included clinical trials enrolled a total of 9215 participants (range = 1051 to 1715 per trial) across three prostate cancer disease states. Within disease states, baseline patient characteristics appeared similar between trials. Of 54 distinct AE types in total, only 3 (fatigue, hypertension, and seizure) were reported by all 7 trials. Absolute risks of AEs in the placebo arms differed systematically and more than two-fold between trials, which was associated with visit frequency and resulted in different degrees of uncertainty in AE profiles between trials. No trial used inferential methodology to quantify statistical uncertainty in AE risks, but 6 of 7 trials drew overall conclusions. Two trials concluded that there was no elevated AE risk due to the intervention, including the trial of darolutamide, which had the greatest statistical uncertainty.
CONCLUSION


Rigorous comparison of drug safety was precluded by heterogeneity in AE reporting, variation in AE risks in the placebo arms, and lack of inferential statistical methodology, underscoring considerable opportunities to improve how AE data are collected, analyzed, and interpreted in oncology trials.",2020,"RESULTS


Seven included clinical trials enrolled a total of 9215 participants (range = 1051 to 1715 per trial) across three prostate cancer disease states.","['advanced prostate cancer', 'Seven included clinical trials enrolled a total of 9215 participants (range = 1051 to 1715 per trial) across three prostate cancer disease states']","['placebo', 'apalutamide, enzalutamide and darolutamide']","['Absolute risks of AEs', 'elevated AE risk', '3 (fatigue, hypertension, and seizure']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0450319', 'cui_str': '1051'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]",9215.0,0.550917,"RESULTS


Seven included clinical trials enrolled a total of 9215 participants (range = 1051 to 1715 per trial) across three prostate cancer disease states.","[{'ForeName': 'Joshua Z', 'Initials': 'JZ', 'LastName': 'Drago', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gönen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Thanarajasingam', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Chana A', 'Initials': 'CA', 'LastName': 'Sacks', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Konrad H', 'Initials': 'KH', 'LastName': 'Stopsack', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa134']
2915,32857933,"Escitalopram in Adolescents With Generalized Anxiety Disorder: A Double-Blind, Randomized, Placebo-Controlled Study.","BACKGROUND


Selective serotonin reuptake inhibitors (SSRIs) are commonly used to treat pediatric anxiety disorders, including generalized anxiety disorder (GAD); however, their efficacy and tolerability are difficult to predict. This study evaluated the efficacy and tolerability of escitalopram in adolescents with GAD (DSM-IV-TR) and the impact of variants in HTR2A and serotonin transporter (SLC6A4) genes and cytochrome P450 2C19 (CYP2C19) phenotypes on response as well as CYP2C19 phenotype on escitalopram pharmacokinetics from February 2015 through November 2018.
METHODS


Patients were treated with escitalopram (forced titration to 15 mg/d, then flexible titration to 20 mg/d) (n = 26, mean ± SD age: 14.8 ± 1.7 years) or placebo (n = 25, mean ± SD age: 14.9 ± 1.6 years) for 8 weeks. Outcomes were the change in scores on the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events. Plasma escitalopram and desmethylcitalopram area under the curve during 24 hours (AUC0-24) and maximum concentration (Cmax) were determined and compared across CYP2C19 phenotypes.
RESULTS


Escitalopram was superior to placebo for mean ± SD baseline-to-endpoint change in PARS (-8.65 ± 1.3 vs -3.52 ± 1.1, P = .005) and CGI scores, and increasing CYP2C19 metabolism was associated with decreases in escitalopram Cmax (P = .07) and AUC0-24 (P < .05). Vital signs, corrected QT interval, and adverse events were similar in patients who received escitalopram and placebo.
CONCLUSIONS


Escitalopram reduces anxiety symptoms, and pharmacogenetics variables influence the trajectory and magnitude of improvement. Variation in CYP2C19 metabolism accounts for significant differences in escitalopram pharmacokinetics, raising the possibility that CYP2C19 phenotype should be considered when prescribing escitalopram.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02818751.",2020,Outcomes were the change in scores on the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events.,"['Adolescents', 'adolescents with GAD (DSM-IV-TR', 'With Generalized Anxiety Disorder', 'Patients were treated with']","['placebo', 'Placebo', 'serotonin reuptake inhibitors (SSRIs', 'escitalopram (forced titration']","['anxiety symptoms', 'Plasma escitalopram and desmethylcitalopram area under the curve during 24 hours (AUC0-24) and maximum concentration (Cmax', 'CYP2C19 metabolism', 'Vital signs, corrected QT interval, and adverse events', 'CGI scores', 'escitalopram Cmax', 'efficacy and tolerability', 'Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162758', 'cui_str': 'Serotonin uptake inhibitor'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0057538', 'cui_str': 'desmethylcitalopram'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.181144,Outcomes were the change in scores on the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events.,"[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'University of Cincinnati, Department of Psychiatry, Box 670559, Cincinnati, OH 45267-0559. strawnjr@uc.edu.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Mills', 'Affiliation': 'Department of Economics, Lindner College of Business, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Schroeder', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Mossman', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Sara T', 'Initials': 'ST', 'LastName': 'Varney', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Ramsey', 'Affiliation': ""Department of Pediatrics, Divisions of Clinical Pharmacology & Research in Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Poweleit', 'Affiliation': ""Department of Pediatrics, Divisions of Clinical Pharmacology & Research in Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana,.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cecil', 'Affiliation': ""Imaging Research Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13396']
2916,32857944,Spinal Manipulation and Electrical Dry Needling in Patients With Subacromial Pain Syndrome: A Multicenter Randomized Clinical Trial.,"OBJECTIVES


To compare the effects of spinal thrust-manipulation and electrical dry needling (TMEDN-group) to nonthrust peripheral joint/soft-tissue mobilization, exercise and interferential current (NTMEX-group) on pain and disability in patients with subacromial pain syndrome (SAPS).
DESIGN


Randomized, single-blinded, multi-center, parallel-group trial.
METHODS


Patients with SAPS were randomized into the TMEDN group (n=73) or the NTMEX group (n=72). Primary outcomes included the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS). Secondary outcomes included Global Rating of Change (GROC) and medication intake. The treatment period was 6 weeks; with follow-up at 2 weeks, 4 weeks, and 3 months.
RESULTS


At 3 months, the TMEDN group experienced greater reductions in shoulder pain and disability (P<0.001) compared to the NTMEX group. Effect sizes were large in favor of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC≥+5) and stopped taking medication (P<0.001).
CONCLUSION


Cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling resulted in greater reductions in pain, disability and medication intake than nonthrust peripheral joint/soft-tissue mobilization, exercise and interferential current in patients with SAPS. These effects were maintained at 3 months.  J Orthop Sports Phys Ther, Epub 28 Aug 2020. doi:10.2519/jospt.2021.9785 .",2020,"At 3 months, the TMEDN group experienced greater reductions in shoulder pain and disability (P<0.001) compared to the NTMEX group.","['Patients with SAPS', 'patients with SAPS', 'patients with subacromial pain syndrome (SAPS', 'Patients With Subacromial Pain Syndrome']","['Spinal Manipulation and Electrical Dry Needling', 'Cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling', 'TMEDN', 'spinal thrust-manipulation and electrical dry needling (TMEDN-group) to nonthrust peripheral joint/soft-tissue mobilization, exercise and interferential current (NTMEX-group', 'NTMEX']","['shoulder pain and disability', 'pain, disability and medication intake', 'pain and disability', 'shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS', 'Global Rating of Change (GROC) and medication intake', 'successful outcome (GROC≥+5) and stopped taking medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0450195', 'cui_str': 'Cervicothoracic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}]",,0.134972,"At 3 months, the TMEDN group experienced greater reductions in shoulder pain and disability (P<0.001) compared to the NTMEX group.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Butts', 'Affiliation': 'American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Copper Queen Community Hospital, Bisbee, AZ.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Goult', 'Affiliation': 'BenchMark Physical Therapy, Atlanta, GA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Gillett', 'Affiliation': 'Eastside Medical Care Center, El Paso, TX.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Arias-Buria', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Jodan', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'Department of Physical Therapy, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Young', 'Affiliation': 'American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.'}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2021.9785']
2917,32858111,Impact of diabetes and insulin use on prognosis in patients with resected pancreatic cancer: an ancillary analysis of NRG Oncology RTOG 9704.,"PURPOSE


Diabetes mellitus (DM) has been proposed to be tumorigenic however, prior studies of the association between DM and survival are conflicting. The goal of this ancillary analysis of XXXX, a randomized controlled trial of adjuvant chemotherapy in pancreatic cancer, was to determine the prognostic impact of DM and insulin use on survival.
PATIENTS AND METHODS


Eligible patients from XXXX with available data on DM and insulin use were included. Overall survival (OS) and disease-free survival (DFS) were estimated by Kaplan-Meier method and variable levels were compared using log-rank test. Cox proportional hazards models were created to assess the association between DM, insulin use, and body mass index (BMI) phenotypes on outcomes.
RESULTS


Of 538 patients enrolled from 1998-2002, 238 patients were eligible with analyzable DM and insulin use data. Overall 34% of patients had DM and 66% did not. Of patients with DM, 64% had insulin dependent DM, and 36% had non-insulin dependent DM. On univariable analysis, neither DM nor insulin dependence were associated with OS or DFS (P>0.05 for all). On multivariable analysis, neither DM, insulin use, nor BMI were independently associated with OS or DFS. Non-white race (HR 2.18, 95% confidence interval (CI) 1.35-3.50, P=0.0014), nodal involvement (HR 1.74, 95% CI 1.24-2.45, P=0.0015), and carbohydrate antigen 19-9 (CA19-9) ≥ 90 U/mL (HR 3.61, 95% CI 2.32-5.63, P<0.001) were associated with decreased OS. Non-white race (HR 1.67, 95% CI 1.05-2.63, P=0.029) and CA19-9 ≥ 90 U/mL (HR 2.86, 95% CI 1.85-4.40, P<0.001) were associated with decreased DFS.
CONCLUSIONS


DM and insulin use were not associated with OS or DFS in patients with pancreatic cancer in this study. Race, nodal involvement, and increased CA19-9 were significant predictors of outcomes. These data may or may not apply to the more modern use of neoadjuvant therapies for potentially resectable pancreatic cancer.",2020,"On univariable analysis, neither DM nor insulin dependence were associated with OS or DFS (P>0.05 for all).","['538 patients enrolled from 1998-2002', 'pancreatic cancer', 'patients with resected pancreatic cancer', 'Diabetes mellitus (DM', '238 patients were eligible with analyzable DM and insulin use data', 'patients with pancreatic cancer', 'Eligible patients from XXXX with available data on DM and insulin use were included']","['adjuvant chemotherapy', 'XXXX']","['nodal involvement', 'Overall survival (OS) and disease-free survival (DFS', 'DM, insulin use, nor BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",238.0,0.266679,"On univariable analysis, neither DM nor insulin dependence were associated with OS or DFS (P>0.05 for all).","[{'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Bitterman', 'Affiliation': 'Harvard Radiation Oncology Program. Electronic address: dbitterman@bwh.harvard.edu.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Winter', 'Affiliation': 'NRG Oncology Statistics and Data Management Center. Electronic address: WinterK@NRGOncology.org.'}, {'ForeName': 'Theodore S', 'Initials': 'TS', 'LastName': 'Hong', 'Affiliation': 'Massachusetts General Hospital Cancer Center.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale University Cancer Center.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Regine', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Abrams', 'Affiliation': 'Rush University Medical Center.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Safran', 'Affiliation': 'Rhode Island Hospital.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Hoffman', 'Affiliation': 'Fox Chase Cancer Center.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kasunic', 'Affiliation': 'Toledo Clinic Cancer Centers-Toledo.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Mulcahy', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Strauss', 'Affiliation': 'Texas Health Resources Presbyterian Hospital Dallas (accrual under University of Texas/Presbyterian Hospital).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'DiPetrillo', 'Affiliation': 'Lifespan-Rhode Island Hospital.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Stella', 'Affiliation': 'St. Joseph Mercy Hospital (accrual under Michigan Cancer Research Consortium CCOP).'}, {'ForeName': 'Yuhchyau', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'University of Rochester.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Plastaras', 'Affiliation': 'University of Pennsylvania/Abramson Cancer Center.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Crane', 'Affiliation': 'Memorial Sloan Kettering Cancer Center.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.08.042']
2918,32858145,Dorsolateral Prefrontal Cortex and Task-Switching Performance: Effects of Anodal Transcranial Direct Current Stimulation.,"Task switching refers to the process by which an individual transfers focus from one cognitive task to another. In recent years, transcranial direct current stimulation (tDCS) technology had been used to investigate the causal relationship between the dorsolateral prefrontal cortex (DLPFC) and task-switching performance. However, the effects of anodal-tDCS (a-tDCS) on task switching remain unclear, and the relationship between DLPFC and various task predictabilities have not yet been studied. Therefore, this study mainly investigated the effects of left anode tDCS (LA) and right anode tDCS (RA) in predictable and unpredictable task-switching performance. Thirty-six participants were randomly assigned to three tDCS groups (including LA, RA, and sham) and were asked to complete both the predictable and unpredictable tasks. Compared with LA and sham tDCS, increasing the activity of the right DLPFC improved task-switching performance (switch cost) of unpredictable but not predictable tasks. The results suggested there is a causal association between DLPFC and unpredictable task switching and implied a task-specific effect in task switching. We concluded that the DLPFC is not essential for exogenous adjustment in predictable task switching.",2020,"Compared with LA and sham tDCS, increasing the activity of the right DLPFC improved task-switching performance (switch cost) of unpredictable but not predictable tasks.",['Thirty-six participants'],"['anodal-tDCS (a-tDCS', 'transcranial direct current stimulation (tDCS) technology', 'left anode tDCS (LA) and right anode tDCS (RA', 'LA and sham tDCS', 'Anodal Transcranial Direct Current Stimulation', 'DLPFC']",['activity of the right DLPFC improved task-switching performance (switch cost'],"[{'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",36.0,0.0211483,"Compared with LA and sham tDCS, increasing the activity of the right DLPFC improved task-switching performance (switch cost) of unpredictable but not predictable tasks.","[{'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Rongjuan', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Abaid', 'Initials': 'A', 'LastName': 'Ur Rehman', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Xuqun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China. Electronic address: youxuqun@snnu.edu.cn.""}]",Neuroscience,['10.1016/j.neuroscience.2020.08.020']
2919,32858210,"A Commentary on ""Effects of Edaravone on Postoperative Cognitive Function in Elderly Patients undergoing Hip Joint Replacement Surgery: A Randomized Controlled Trial"" (Int J Surg 2020;80:13-18).",,2020,,['Elderly Patients undergoing Hip Joint Replacement Surgery'],['Edaravone'],['Postoperative Cognitive Function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Mingcheng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: ymc19950616@163.com.'}, {'ForeName': 'Zichuan', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zichuanding@163.com.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zongke2017@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.067']
2920,32858214,Effects of A Nurse-Led Death Education Intervention for Older People with Chronic Disease and Family Caregivers: A Quasi-Experimental Study.,"PURPOSE


To investigate the effectiveness of a structured death education program for older adults with chronic illness and their family caregivers.
METHODS


This study adopted two-group, non-randomized quasi-experimental design. Patient-caregiver dyads in the intervention group (N=40 dyads) engaged in the death education program at the bedside once a week for five weeks, were compared with participants (N=40 dyads) in the control group received usual health education. The program consisted of five sessions based on the Interaction Model of Client Health Behavior. Death attitude, death competence, well-being, family function and satisfaction were measured at baseline (T0), immediately after the intervention (T1) and one month later (T2). Data collection was conducted from July 30, 2019 to December 30, 2019.
RESULTS


The intention-to-treat analysis of between groups at 1-month follow-up revealed that the intervention group had greater decreases in the fear of death (p=.002, p<.001) and death avoidance (p<.001, p<.001), had greater increases in the neutral acceptance (p=.032, p<.001) and death competence (p<.001, p<.001) in patients and caregivers, respectively. There were significant intergroup differences over time for patient well-being of 6.40 (3.06, 9.74) and satisfaction of 3.30 (2.01, 4.59), with both p<.001. Results were consistent with the results from the sensitivity analysis.
CONCLUSIONS


This study demonstrated the feasibility and benefits of death education in hospitals and provided an implementation plan for nursing professionals. Nurses should consider providing death education for older adults with chronic diseases and their families to promote the development of palliative care and the quality of end-of-life.",2020,"There were significant intergroup differences over time for patient well-being of 6.40 (3.06, 9.74) and satisfaction of 3.30 (2.01, 4.59), with both p<.001.","['Data collection was conducted from July 30, 2019 to December 30, 2019', 'older adults with chronic illness and their family caregivers', 'Older People with Chronic Disease and Family Caregivers', 'older adults with chronic diseases']","['structured death education program', 'control group received usual health education', 'death education program', 'Nurse-Led Death Education Intervention']","['neutral acceptance', 'death competence', 'Death attitude, death competence, well-being, family function and satisfaction', 'fear of death', 'death avoidance']","[{'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0004274', 'cui_str': 'Attitudes to Death'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}]",,0.0828362,"There were significant intergroup differences over time for patient well-being of 6.40 (3.06, 9.74) and satisfaction of 3.30 (2.01, 4.59), with both p<.001.","[{'ForeName': 'Weilin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Geriatrics, Renmin Hospital of Wuhan University, Wuhan 430060, China. Electronic address: willachen@whu.edu.cn.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Geriatrics, Renmin Hospital of Wuhan University, Wuhan 430060, China. Electronic address: mahmwhurmh@163.com.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatrics, Renmin Hospital of Wuhan University, Wuhan 430060, China. Electronic address: wx13147104128@163.com.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Geriatrics, Renmin Hospital of Wuhan University, Wuhan 430060, China. Electronic address: j2945017399@126.com.'}]",Asian nursing research,['10.1016/j.anr.2020.08.002']
2921,32858227,"The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial.","BACKGROUND AND OBJECTIVES


Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. The objective of this randomized controlled trial (RCT) is to evaluate the efficacy of the Geriatric Emergency Department Innovations (GEDI) program, an ED nurse-led geriatric assessment and care coordination program, in decreasing unnecessary health services use and improving Health-Related Quality-of-Life (HRQoL) for older adults in the ED.
METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420). Outcome variables will be assessed during the ED visit and at 7-11 days and 28-32 days post ED visit.
PROJECTED OUTCOMES


The primary outcome is hospitalization or death within 30 days of the ED visit. Secondary outcomes include health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression].
TRIAL REGISTRATION


Clinicaltrials.Gov identifier NCT04115371.",2020,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","['Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either', 'older adults in the ED', 'Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits']","['Geriatric Emergency Department Innovations (GEDI', 'GEDI (n\u202f=\u202f420) or to usual ED care']","['health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression', 'hospitalization or death within 30\u202fdays of the ED visit', 'infections, delirium, and falls', 'Health-Related Quality-of-Life (HRQoL']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.106207,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Dresden', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: sdresden@nm.org.'}, {'ForeName': 'Alexander X', 'Initials': 'AX', 'LastName': 'Lo', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Lindquist', 'Affiliation': 'Department of Internal Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lori Ann', 'Initials': 'LA', 'LastName': 'Post', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'French', 'Affiliation': 'Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, USA; Department of Veterans Affairs Health Services Research and Development Service, Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University and Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106125']
2922,32858228,DO-HEALTH: Vitamin D3 - Omega3 - Home exercise - Healthy aging and longevity trial - Design of a multinational clinical trial on healthy aging among European seniors.,"DO-HEALTH is a multi-center clinical trial among 2157 community-dwelling European men and women age 70 and older. The 2x2x2 randomized-control factorial design trial tested the individual and additive benefit, as well as the cost-effectiveness, of 3 interventions: vitamin D 2000 IU/day, omega-3 fatty acids 1000 mg/day (EPA + DHA, ratio 1:2), and a 30-minute 3 times/week home exercise (strength versus flexibility). Each treatment tested has shown considerable prior promise from mechanistic studies, small clinical trials, or large cohort studies, in the prevention of common age-related chronic diseases, but definitive data are missing. DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty). As the 3 interventions have distinct mechanisms of action for each of the 6 primary endpoints, a maximum benefit is expected for their additive benefit as a ""multi-modal"" intervention. The trial duration is 3 years with in-person contacts with all participants at 4 clinical visits and by quarterly phone calls. Baseline and follow-up blood samples were collected in all participants to measure changes in 25-hydroxyvitamin D and poly-unsaturated fatty acid concentrations. Our objective was to test interventions that are expected to promote healthy aging and longer life expectancy and that can be easily and safely implemented by older community-dwelling adults.",2020,"DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty).","['healthy aging among European seniors', 'older community-dwelling adults', '3\u202fyears with in-person contacts with all participants at 4 clinical visits and by quarterly phone calls', '2157 community-dwelling European men and women age 70 and older']","['3 interventions: vitamin D 2000\u202fIU/day, omega-3 fatty acids 1000']","['falls and injurious falls, joint pain, oral health, quality of life, and incident frailty', 'systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections', '25-hydroxyvitamin D and poly-unsaturated fatty acid concentrations']","[{'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",2157.0,0.100229,"DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty).","[{'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, Waid City Hospital and University of Zurich, Zurich, Switzerland; Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland. Electronic address: Heike.Bischoff@usz.ch.'}, {'ForeName': 'Caroline de Godoi Rezende Costa', 'Initials': 'CGRC', 'LastName': 'Molino', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, Waid City Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Rival', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, Waid City Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Center Hospitalo-Universitaire de Toulouse, Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rizzoli', 'Affiliation': 'Division of Bone Diseases, Geneva University Hospitals, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Reto W', 'Initials': 'RW', 'LastName': 'Kressig', 'Affiliation': 'University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Centre for Metabolic Bone Diseases, University of Sheffield Medical School, United Kingdom; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Endel J', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'José A P', 'Initials': 'JAP', 'LastName': 'da Silva', 'Affiliation': 'Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blauth', 'Affiliation': 'Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Center for Muscle and Bone Research, Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, , Germany.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ferrari', 'Affiliation': 'Ferrari Data Solutions, Feldmeilen, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, Waid City Hospital and University of Zurich, Zurich, Switzerland; Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, Waid City Hospital and University of Zurich, Zurich, Switzerland; Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106124']
2923,32858229,A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial.,"BACKGROUND


Gait and cognitive impairments are common in individuals with Multiple Sclerosis (MS) and can interfere with everyday function. Those with MS have difficulties executing cognitive tasks and walking simultaneously, a reflection of dual-task interference. Therefore, dual-task training may improve functional ambulation. Additionally, using technology such as virtual reality can provide personalized rehabilitation while mimicking real-world environments. The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms compared to conventional treadmill training.
METHODS


This study will be a single-blinded, two arm RCT with a six-week intervention period. 144 people with MS will be randomized into a treadmill training alone group or treadmill training with virtual reality group. Both groups will receive 18 sessions of training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system. Primary outcome measures include dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training.
DISCUSSION


This study will provide insight into the ability of a multi-modal cognitive-motor intervention to reduce dual-task cost and to enhance information processing speed in those with MS. This is one of the first studies that is powered to understand whether targeted dual-task training can improve MS symptoms and increase functional ambulation. We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.",2020,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"['people with multiple sclerosis', '144 people with MS', 'individuals with Multiple Sclerosis (MS']","['conventional treadmill training', 'combined cognitive-motor virtual reality training', 'modal virtual reality treadmill intervention', 'treadmill training alone group or treadmill training with virtual reality group', 'dual-task training', 'training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system']","['dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training', 'mobility and cognitive function', 'functional ambulation', 'dual-task gait speed and information processing speed', 'MS symptoms and increase functional ambulation', 'MS symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376392', 'cui_str': 'Virtual Systems'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",144.0,0.0521126,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shema-Shiratzky', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galperin', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Regev', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schmitz-Hübsch', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Devos', 'Affiliation': 'Laboratory for Advanced Rehabilitation Research in Simulation, Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sosnoff', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': ""Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Rush Alzheimer's Disease Center and Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA. Electronic address: jhausdor@tlvmc.gov.il.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106122']
2924,32858239,Polyvalent mechanical bacterial lysate administration improves the clinical course of grass pollen-induced allergic rhinitis in children: a randomised controlled trial.,"BACKGROUND


Recent studies highlight the immunoregulatory potential of bacterial lysates, indicating their potential use in the prevention and treatment of allergic diseases.
OBJECTIVE


We aimed to investigate the clinical efficacy of polyvalent mechanical bacterial lysates (PMBL) in children with grass pollen-induced allergic rhinitis.
METHODS


Seventy children with seasonal allergic rhinitis (SAR) were enrolled to this study and were randomly assigned to the PMBL and placebo group. Severity of SAR symptoms were assessed by the total nasal symptom score (TNSS), total ocular symptom score (TOSS) and visual analogue scale (VAS). During three visits, peak nasal inspiratory flow (PNIF) was measured, nasal smears for the presence of eosinophils and nasal lavage fluids for the presence of asIgE against timothy grass pollen allergens were sampled.
RESULTS


A statistically significant decrease of TNSS (p=0.001), TOSS (p=0.04), VAS for nasal and eye symptoms (p<0.001, p<0.001, respectively) and increase of PNIF (p=0.04) were observed in the PMBL group vs. placebo group. During the grass pollen season an increase and then a decrease in the number of eosinophils in nasal smears was observed in both groups, however, the number of eosinophils was significantly lower in the PMBL group vs. placebo group. No significant changes in asIgE concentrations were observed in the PMBL group, while in the placebo group a statistically significant increase in asIgE concentration was observed.
CONCLUSION


Sublingual administration of PMBL during the grass pollen season offers significant efficacy in alleviating SAR symptoms in children sensitized to grass pollen allergens. PMBL probably affects mucosal immunity, weakening the response of Th2 cells.",2020,"RESULTS


A statistically significant decrease of TNSS (p=0.001), TOSS (p=0.04), VAS for nasal and eye symptoms (p<0.001, p<0.001, respectively) and increase of PNIF (p=0.04) were observed in the PMBL group vs. placebo group.","['children sensitized to grass pollen allergens', 'grass pollen-induced allergic rhinitis in children', 'children with grass pollen-induced allergic rhinitis', 'Seventy children with seasonal allergic rhinitis (SAR']","['PMBL', 'Polyvalent mechanical bacterial lysate administration', 'polyvalent mechanical bacterial lysates (PMBL', 'placebo', 'PMBL and placebo']","['number of eosinophils in nasal smears', 'peak nasal inspiratory flow (PNIF', 'Severity of SAR symptoms', 'asIgE concentration', 'number of eosinophils', 'TOSS', 'TNSS', 'SAR symptoms', 'asIgE concentrations', 'total nasal symptom score (TNSS), total ocular symptom score (TOSS) and visual analogue scale (VAS', 'PNIF', 'VAS for nasal and eye symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444971', 'cui_str': 'Grass pollen allergen'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}]","[{'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}]",70.0,0.280302,"RESULTS


A statistically significant decrease of TNSS (p=0.001), TOSS (p=0.04), VAS for nasal and eye symptoms (p<0.001, p<0.001, respectively) and increase of PNIF (p=0.04) were observed in the PMBL group vs. placebo group.","[{'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Janeczek', 'Affiliation': 'Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, 20-059 Lublin, Poland. Electronic address: kamil.janeczek@umlub.pl.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Emeryk', 'Affiliation': 'Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, 20-059 Lublin, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rachel', 'Affiliation': 'Chair and Department of Human Physiology and Pathophysiology, University of Rzeszów, 35-359 Rzeszów, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Duma', 'Affiliation': 'Department of Laboratory Diagnostics, Medical University of Lublin, 20-059 Lublin, Poland.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Applied and Social Pharmacy, Medical University of Lublin, 20-059 Lublin, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Poleszak', 'Affiliation': 'Department of Applied and Social Pharmacy, Medical University of Lublin, 20-059 Lublin, Poland.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.025']
2925,32858247,Control of Pain in Intravitreal Injections (COPIVIN): Evaluation of Combination Topical Anesthetics and Non-Steroidal Anti-Inflammatory Drops (NSAIDs).,"Our randomized, double-blind, placebo-controlled trial investigated the utility of NSAID drops in pain control following intravitreal injection. The addition of topical NSAID to proparacaine drops and lidocaine ophthalmic gel had negligible effect on subjective pain.",2020,The addition of topical NSAID to proparacaine drops and lidocaine ophthalmic gel had negligible effect on subjective pain.,['pain control following intravitreal injection'],"['proparacaine', 'Combination Topical Anesthetics and Non-Steroidal Anti-Inflammatory Drops (NSAIDs', 'lidocaine ophthalmic gel', 'NSAID drops', 'placebo']",['subjective pain'],"[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0072510', 'cui_str': 'proparacaine'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C2366224', 'cui_str': 'Lidocaine Ophthalmic Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.496621,The addition of topical NSAID to proparacaine drops and lidocaine ophthalmic gel had negligible effect on subjective pain.,"[{'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Wingelaar', 'Affiliation': 'University of Wisconsin-Madison Department of Ophthalmology and Visual Sciences, Madison, WI, USA. Electronic address: mwingelaar@uwhealth.org.'}, {'ForeName': 'C Rufus', 'Initials': 'CR', 'LastName': 'Sweeney', 'Affiliation': 'University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Thomas-Virnig', 'Affiliation': 'University of Wisconsin-Madison Department of Ophthalmology and Visual Sciences, Madison, WI, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Raevis', 'Affiliation': 'University of Wisconsin-Madison Department of Ophthalmology and Visual Sciences, Madison, WI, USA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'University of Wisconsin-Madison Department of Ophthalmology and Visual Sciences, Madison, WI, USA.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Mititelu', 'Affiliation': 'University of Wisconsin-Madison Department of Ophthalmology and Visual Sciences, Madison, WI, USA.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.08.015']
2926,32860031,"Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA, lowers triglycerides and atherogenic lipoproteins in patients with diabetes, hepatic steatosis, and hypertriglyceridaemia.","AIMS 


Loss-of-function mutations in ANGPTL3 are associated with beneficial effects on lipid and glucose metabolism and reduced risk of coronary artery disease. Vupanorsen (AKCEA-ANGPTL3-L Rx ) is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits angiopoietin-like 3 (ANGPTL3) protein synthesis.
METHODS AND RESULTS 


This was a double-blind, placebo-controlled, dose-ranging, Phase 2 study. Patients (N =105) with fasting triglycerides >150 mg/dL (>1.7 mmol/L), type 2 diabetes, and hepatic steatosis were treated for 6 months with 40 or 80 mg every 4 weeks (Q4W), or 20 mg every week (QW) of vupanorsen, or placebo given subcutaneously. The primary efficacy endpoint was per cent change in fasting triglycerides from baseline at 6 months. Median baseline triglycerides were 2.84 mmol/L (252 mg/dL). Significant reductions in triglycerides of 36%, 53%, 47%, and in ANGPTL3 of 41%, 59%, 56%, were observed in the 40 mg Q4W, 80 mg Q4W, and 20 mg QW groups, respectively, compared with 16% reduction in triglycerides and 8% increase in ANGPTL3 in placebo. Compared with placebo, vupanorsen 80 mg Q4W reduced apolipoprotein C-III (58%), remnant cholesterol (38%), total cholesterol (19%), non-high-density lipoprotein cholesterol (HDL-C; 18%), HDL-C (24%), and apolipoprotein B (9%). There was no improvement in glycaemic parameters, or hepatic fat fraction. Treatment with vupanorsen was not associated with clinically significant changes in platelet counts, and the most common adverse events were those at the injection site, which were generally mild.
CONCLUSION 


Vupanorsen results in a favourable lipid/lipoprotein profile and provides a potential strategy for residual cardiovascular risk reduction.",2020,"Treatment with vupanorsen was not associated with clinically significant changes in platelet counts, and the most common adverse events were those at the injection site, which were generally mild.
","['Patients (N =105) with fasting triglycerides >150 mg/dL (>1.7 mmol/L), type 2 diabetes, and hepatic steatosis', 'patients with diabetes, hepatic steatosis, and hypertriglyceridaemia']","['vupanorsen, or placebo', 'placebo', 'Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA']","['remnant cholesterol', 'total cholesterol', 'platelet counts', 'apolipoprotein C-III', 'glycaemic parameters, or hepatic fat fraction', 'per cent change in fasting triglycerides', 'triglycerides and atherogenic lipoproteins', 'non-high-density lipoprotein cholesterol', 'triglycerides', 'Median baseline triglycerides', 'apolipoprotein B']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0301665', 'cui_str': 'n-Acetyl galactosamine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1113649', 'cui_str': 'Angiopoietins'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0052191', 'cui_str': 'Apolipoprotein C-III'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}]",105.0,0.206098,"Treatment with vupanorsen was not associated with clinically significant changes in platelet counts, and the most common adverse events were those at the injection site, which were generally mild.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Department of Medicine, Université de Montréal and Ecogene-21 Clinical Research Centre, Chicoutimi, QC, Canada.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Karwatowska-Prokopczuk', 'Affiliation': 'Akcea Therapeutics, Inc, Boston, MA, USA.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'Excel Medical Clinical Trials, LLC, Boca Raton, FL, USA.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Hurh', 'Affiliation': 'Akcea Therapeutics, Inc, Boston, MA, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Kingsbury', 'Affiliation': 'Akcea Therapeutics, Inc, Boston, MA, USA.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Bartlett', 'Affiliation': 'Akcea Therapeutics, Inc, Boston, MA, USA.'}, {'ForeName': 'Amparo L', 'Initials': 'AL', 'LastName': 'Figueroa', 'Affiliation': 'Akcea Therapeutics, Inc, Boston, MA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Piscitelli', 'Affiliation': 'Akcea Therapeutics, Inc, Boston, MA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Singleton', 'Affiliation': 'Ionis Pharmaceuticals, Inc, Carlsbad, CA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Department of Medicine, University California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Ionis Pharmaceuticals, Inc, Carlsbad, CA, USA.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Ionis Pharmaceuticals, Inc, Carlsbad, CA, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': ""St L O'Dea"", 'Affiliation': 'Akcea Therapeutics, Inc, Boston, MA, USA.'}]",European heart journal,['10.1093/eurheartj/ehaa689']
2927,32860032,Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial.,"AIMS


Despite the effects of statins in reducing cardiovascular events and slowing progression of coronary atherosclerosis, significant cardiovascular (CV) risk remains. Icosapent ethyl (IPE), a highly purified eicosapentaenoic acid ethyl ester, added to a statin was shown to reduce initial CV events by 25% and total CV events by 32% in the REDUCE-IT trial, with the mechanisms of benefit not yet fully explained. The EVAPORATE trial sought to determine whether IPE 4 g/day, as an adjunct to diet and statin therapy, would result in a greater change from baseline in plaque volume, measured by serial multidetector computed tomography (MDCT), than placebo in statin-treated patients.
METHODS AND RESULTS


A total of 80 patients were enrolled in this randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis as documented by MDCT (one or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels. Patients underwent an interim scan at 9 months and a final scan at 18 months with coronary computed tomographic angiography. The pre-specified primary endpoint was changed in low-attenuation plaque (LAP) volume at 18 months between IPE and placebo groups. Baseline demographics, vitals, and laboratory results were not significantly different between the IPE and placebo groups; the median TG level was 259.1 ± 78.1 mg/dL. There was a significant reduction in the primary endpoint as IPE reduced LAP plaque volume by 17%, while in the placebo group LAP plaque volume more than doubled (+109%) (P = 0.0061). There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P < 0.01 for all). When further adjusted for age, sex, diabetes status, hypertension, and baseline TG, plaque volume changes between groups remained significantly different, P < 0.01. Only dense calcium did not show a significant difference between groups in multivariable modelling (P = 0.053).
CONCLUSIONS


Icosapent ethyl demonstrated significant regression of LAP volume on MDCT compared with placebo over 18 months. EVAPORATE provides important mechanistic data on plaque characteristics that may have relevance to the REDUCE-IT results and clinical use of IPE.",2020,"There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P < 0.01 for all).","['A total of 80 patients', 'patients with elevated triglycerides on statin therapy']","['coronary computed tomographic angiography', 'eicosapentaenoic acid ethyl ester', 'statins', 'Icosapent ethyl (IPE', 'placebo', 'MDCT', 'icosapent ethyl']","['elevated triglyceride (TG) levels', 'plaque volumes including fibrous, and fibrofatty (FF) plaque volumes', 'IPE reduced LAP plaque volume', 'LAP volume', 'low-attenuation plaque (LAP) volume', 'Baseline demographics, vitals, and laboratory results', 'initial CV events', 'coronary atherosclerosis', 'progression of coronary atherosclerosis', 'cardiovascular events', 'LAP plaque volume', 'rates of progression', 'median TG level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",80.0,0.343818,"There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P < 0.01 for all).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Suvasini', 'Initials': 'S', 'LastName': 'Lakshmanan', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Muhlestein', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Viet T', 'Initials': 'VT', 'LastName': 'Le', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Heidi T', 'Initials': 'HT', 'LastName': 'May', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Chandana', 'Initials': 'C', 'LastName': 'Shekar', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Roy', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tayek', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Nelson', 'Affiliation': 'California Cardiovascular Institute, Fresno, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehaa652']
2928,32860034,Time-to-treatment initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT).,"AIMS


The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated the benefits of targeting inflammation after myocardial infarction (MI). We aimed to determine whether time-to-treatment initiation (TTI) influences the beneficial impact of colchicine.
METHODS AND RESULTS


In COLCOT, patients were randomly assigned to receive colchicine or placebo within 30 days post-MI. Time-to-treatment initiation was defined as the length of time between the index MI and the initiation of study medication. The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The relationship between endpoints and various TTI (<3, 4-7 and >8 days) was examined using multivariable Cox regression models. Amongst the 4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata. After a median follow-up of 22.7 months, there was a significant reduction in the incidence of the primary endpoint for patients in whom colchicine was initiated < Day 3 compared with placebo [hazard ratios (HR) = 0.52, 95% confidence intervals (CI) 0.32-0.84], in contrast to patients in whom colchicine was initiated between Days 4 and 7 (HR = 0.96, 95% CI 0.53-1.75) or > Day 8 (HR = 0.82, 95% CI 0.61-1.11). The beneficial effects of early initiation of colchicine were also demonstrated for urgent hospitalization for angina requiring revascularization (HR = 0.35), all coronary revascularization (HR = 0.63), and the composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke (HR = 0.55, all P < 0.05).
CONCLUSION


Patients benefit from early, in-hospital initiation of colchicine after MI.
TRIAL REGISTRATION


COLCOT ClinicalTrials.gov number, NCT02551094.",2020,"The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization.","['4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata']","['colchicine or placebo', 'colchicine', 'placebo']","['composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization', 'urgent hospitalization for angina requiring revascularization', 'composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",4661.0,0.451585,"The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization.","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bouabdallaoui', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Waters', 'Affiliation': 'San Francisco General Hospital, California.'}, {'ForeName': 'Fausto J', 'Initials': 'FJ', 'LastName': 'Pinto', 'Affiliation': 'Santa Maria University Hospital (CHULN), CAML, CCUL, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Firenze, Italy.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clinicos Latinoamerica, Rosario, Argentina.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'University of Glasgow and NHS Glasgow Clinical Research Facility, Glasgow, UK.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': 'H La Paz, IdiPaz, UAM, Ciber-CV Madrid, Spain.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Gamra', 'Affiliation': 'Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Ghassan S', 'Initials': 'GS', 'LastName': 'Kiwan', 'Affiliation': 'Bellevue Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Blondeau', 'Affiliation': 'The Montreal Health Innovations Coordinating Center (MHICC), Montreal, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Orfanos', 'Affiliation': 'The Montreal Health Innovations Coordinating Center (MHICC), Montreal, Canada.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Grégoire', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Samuel', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Morel', 'Affiliation': 'Division of Cardiovascular Medicine, Nouvel Hôpital Civil, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, AP-HP, Hôpital Universitaire Henri-Mondor and INSERM U955, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': 'Institut de Cardiologie et Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kouz', 'Affiliation': 'Centre Hospitalier Régional de Lanaudière, Joliette, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Guertin', 'Affiliation': 'The Montreal Health Innovations Coordinating Center (MHICC), Montreal, Canada.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': ""L'Allier"", 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France.'}]",European heart journal,['10.1093/eurheartj/ehaa659']
2929,32860041,Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial.,"AIMS 


To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS).
METHODS AND RESULTS 


In this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n = 388, VKA n = 389) vs. CCS (edoxaban n = 363, VKA = 366). Participants received edoxaban 60 mg once-daily plus a P2Y12 inhibitor for 12 months, or VKA combined with a P2Y12 inhibitor and aspirin 100 mg (for 1-12 months). The primary bleeding endpoint at 12 months occurred in 59 (15.2%) vs. 79 (20.3%) ACS patients [hazard ratio (HR): 0.73, 95% confidence interval (CI): 0.59-1.02, P = 0.063], and in 69 (19.0%) vs. 73 (19.9%) CCS patients (HR: 0.94, 95%CI: 0.68-1.31, P = 0.708) with edoxaban- and VKA-based therapy, respectively [P for interaction (P-int) = 0.2741]. The main secondary endpoint (composite of CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis) in ACS patients was 33 (8.5%) vs. 28 (7.2%) (HR: 1.16, 95%CI: 0.70-1.92), compared with 16 (4.4%) vs. 18 (4.9%) (HR: 0.91, 95%CI: 0.47-1.78) CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573).
CONCLUSIONS 


In patients with AF who underwent PCI, the edoxaban-based regimen, as compared with VKA-based regimen, provides consistent safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation.",2020,"CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573).
","['patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS', 'patients with AF regardless of their clinical presentation', 'CCS patients with', 'atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation']","['edoxaban 60\u2009mg once-daily plus a P2Y12 inhibitor for 12\u2009months, or VKA combined with a P2Y12 inhibitor and aspirin', 'percutaneous coronary intervention (PCI', 'edoxaban', 'CCS', 'Edoxaban', 'edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n\u2009=\u2009388, VKA n\u2009=\u2009389) vs. CCS (edoxaban']","['CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis', 'safety and efficacy', 'primary bleeding endpoint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C3872158', 'cui_str': 'edoxaban 60 MG [Savaysa]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C4517752', 'cui_str': '389'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.199703,"CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573).
","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology & Critical Care Jessaziekenhuis Hasselt, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eckardt', 'Affiliation': 'Atrial Fibrillation Network (AFNET), Münster, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Lewalter', 'Affiliation': 'Atrial Fibrillation Network (AFNET), Münster, Germany.'}, {'ForeName': 'Ramunas', 'Initials': 'R', 'LastName': 'Unikas', 'Affiliation': 'University of Health Sciences hospital, Kaunas, Lithuanian, Lithuania.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Marin', 'Affiliation': 'Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, CIBERCV, Murcia, Spain.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Schiele', 'Affiliation': 'Chru Jean Minjoz, Besancon, France.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Laeis', 'Affiliation': 'Daiichi Sankyo Europe GmbH, München, Germany.'}, {'ForeName': 'Paul-Egbert', 'Initials': 'PE', 'LastName': 'Reimitz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, München, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Smolnik', 'Affiliation': 'Daiichi Sankyo Europe GmbH, München, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zierhut', 'Affiliation': 'Daiichi Sankyo Europe GmbH, München, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'Atrial Fibrillation Network (AFNET), Münster, Germany.'}]",European heart journal,['10.1093/eurheartj/ehaa617']
2930,32860075,Risk of relapse after anti-PD1 discontinuation in patients with Hodgkin lymphoma.,"INTRODUCTION


Patients with relapsed/refractory Hodgkin lymphoma (R/R HL) experience high response rates upon anti-PD1 therapy. In these patients, the optimal duration of treatment and the risk of relapse after anti-PD1 discontinuation are unknown.
METHODS


We retrospectively analyzed patients with R/R HL who responded to anti-PD1 monotherapy and discontinued the treatment either because of unacceptable toxicity or prolonged remission. A machine learning algorithm based on 17 candidate variables was trained and validated to predict progression-free survival (PFS) landmarked at the time of discontinuation of anti-PD1 therapy.
RESULTS


Forty patients from 14 centers were randomly assigned to training (n = 25) and validation (n = 15) sets. At the time of anti-PD1 discontinuation, patients had received treatment for a median duration of 11.2 (range, 0-time to best response was not statistically significant in discriminating patients with PFS lesser or greater than 12 months). Considering PFS status as a binary variable (alive or dead) at a specific time point (12 months) is convenient, intuitive and allows for comparing the value of potential predicting variables in these two groups of patients. Nonetheless, this approach has two drawbacks: first, it binarizes outcome; second, it excludes patients alive with a time to last follow up lesser 12 months. Therefore, it is less powerful to demonstrate statistically significant association with PFS even if it exists 5 months. Patients discontinued anti-PD1 treatment either because of prolonged remission (N = 27, 67.5%) or unacceptable toxicity (N = 13, 32.5%). Most patients were in CR (N = 35, 87.5%) at the time of anti-PD1 discontinuation. In the training set, the machine learning algorithm identified that the most important variables to predict PFS were patients' age, time to best response, and presence or absence of CR. The performance observed in the training set was validated in the validation set.
CONCLUSION


In this pilot, proof of concept study using a machine learning algorithm, we identified biomarkers capable of predicting the risk of relapse after anti-PD1 discontinuation (age, time to best response, quality of response). Once confirmed, these simple biomarkers will represent useful tools to guide the management of these patients.",2020,"Most patients were in CR (N = 35, 87.5%) at the time of anti-PD1 discontinuation.","['patients with Hodgkin lymphoma', 'Forty patients from 14 centers']",['machine learning algorithm'],"['unacceptable toxicity or prolonged remission', 'unacceptable toxicity', 'prolonged remission', 'Risk of relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",40.0,0.0215256,"Most patients were in CR (N = 35, 87.5%) at the time of anti-PD1 discontinuation.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Manson', 'Affiliation': 'Department of Hematology, University Hospital of Rennes, 2 rue Henri Le Guilloux, 35033, Rennes Cedex 9, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Department of Hematology, Saint-Louis Hospital, AP-HP, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Herbaux', 'Affiliation': 'Department of Hematology, University Hospital of Lille, Lille, France.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Silva', 'Affiliation': 'Department of Hematology, Instituto Português de Oncologia de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Hematology, University Hospital of Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Deau', 'Affiliation': 'Department of Hematology, Cochin Hospital, AP-HP, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bouteloup', 'Affiliation': 'Department of Hematology, Chalon Hospital, Chalon-sur-Saone, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Schiano', 'Affiliation': 'Department of Hematology, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'Department of Hematology, Leon Berard Center, Lyon, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maerevoet', 'Affiliation': 'Institut Bordet, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ghesquieres', 'Affiliation': 'Department of Hematology, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stamatoullas', 'Affiliation': 'Department of Hematology,, Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Antier', 'Affiliation': 'Department of Hematology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carlo-Stella', 'Affiliation': 'Department of Oncology and Hematology, Humanitas Clinical and Research Center - IRCCS, Rozzano, MI, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Charette', 'Affiliation': 'Department of Hematology, University Hospital of Lille, Lille, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Poizeau', 'Affiliation': 'Department of Dermatology, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dercle', 'Affiliation': 'UMR1015, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Roch', 'Initials': 'R', 'LastName': 'Houot', 'Affiliation': 'Department of Hematology, University Hospital of Rennes, 2 rue Henri Le Guilloux, 35033, Rennes Cedex 9, France. roch.houot@chu-rennes.fr.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-020-05015-2']
2931,32389224,Cost-Effectiveness of Radiofrequency Denervation for Patients With Chronic Low Back Pain: The MINT Randomized Clinical Trials.,"OBJECTIVES


To evaluate the cost-effectiveness of radiofrequency denervation when added to a standardized exercise program for patients with chronic low back pain.
METHODS


An economic evaluation was conducted alongside 3 pragmatic multicenter, nonblinded randomized clinical trials (RCTs) in The Netherlands with a follow up of 52 weeks. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain; a positive diagnostic block at the facet joints (n = 251), sacroiliac (SI) joints (n = 228), or a combination of facet joints, SI joints, and intervertebral discs (n = 202); and were unresponsive to initial conservative care. Quality-adjusted life-years (QALYs) and societal costs were measured using self-reported questionnaires. Missing data were imputed using multiple imputation. Bootstrapping was used to estimate statistical uncertainty.
RESULTS


After 52 weeks, no difference in costs between groups was found in the facet joint or combination RCT. The total costs were significantly higher for the intervention group in the SI joint RCT. The maximum probability of radiofrequency denervation being cost-effective when added to a standardized exercise program ranged from 0.10 in the facet joint RCT to 0.17 in the SI joint RCT irrespective of the ceiling ratio, and 0.65 at a ceiling ratio of €30 000 per QALY in the combination RCT.
CONCLUSIONS


Although equivocal among patients with symptoms in a combination of the facet joints, SI joints, and intervertebral discs, evidence suggests that radiofrequency denervation combined with a standardized exercise program cannot be considered cost-effective from a societal perspective for patients with chronic low back pain originating from either facet or SI joints in a Dutch healthcare setting.",2020,"After 52 weeks, no difference in costs between groups was found in the facet joint or combination RCT.","['Patients With Chronic Low Back Pain', 'patients with chronic low back pain', 'patients with chronic low back pain originating from either facet or SI joints in a Dutch healthcare setting', 'Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain; a positive diagnostic block at the facet joints (n\xa0= 251), sacroiliac (SI) joints (n\xa0= 228), or a combination of facet joints, SI joints, and intervertebral discs (n\xa0= 202); and were unresponsive to initial conservative care']","['radiofrequency denervation', 'standardized exercise program', 'Radiofrequency Denervation']","['Cost-Effectiveness', 'costs', 'total costs', 'Quality-adjusted life-years (QALYs) and societal costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224521', 'cui_str': 'Zygapophyseal joint structure'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C1740811', 'cui_str': 'Radiofrequency denervation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.141148,"After 52 weeks, no difference in costs between groups was found in the facet joint or combination RCT.","[{'ForeName': 'Esther T', 'Initials': 'ET', 'LastName': 'Maas', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Amsterdam Movement Science Research Institute, Amsterdam, The Netherlands. Electronic address: esther.maas@ubc.ca.'}, {'ForeName': 'Johan N S', 'Initials': 'JNS', 'LastName': 'Juch', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Raymond W J G', 'Initials': 'RWJG', 'LastName': 'Ostelo', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Amsterdam Movement Science Research Institute, Amsterdam, The Netherlands; Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'J George', 'Initials': 'JG', 'LastName': 'Groeneweg', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'Kallewaard', 'Affiliation': 'Department of Anesthesiology, Rijnstate Hospital, Velp, The Netherlands.'}, {'ForeName': 'Bart W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Arianne P', 'Initials': 'AP', 'LastName': 'Verhagen', 'Affiliation': 'Department of General Practice, Erasmus University Medical Centre, Rotterdam, The Netherlands; Graduate School of Health, Discipline of Physiotherapy, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Amsterdam Movement Science Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Amsterdam Movement Science Research Institute, Amsterdam, The Netherlands; Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Frank J P M', 'Initials': 'FJPM', 'LastName': 'Huygen', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.12.009']
2932,30445507,"Formative, multimethod case studies of learn to quit, an acceptance and commitment therapy smoking cessation app designed for people with serious mental illness.","Despite public health efforts, individuals with serious mental illness (SMI) still have very high rates of tobacco smoking. Innovative approaches to reach this population are needed. These series of case studies aimed to descriptively evaluate the usability, user experience (UX), and user engagement (UE) of Learn to Quit (LTQ), an acceptance and commitment therapy smoking cessation app designed for people with SMI, and to compare it with an app designed for the general population, NCI (National Cancer Institute) QuitGuide (QG). Both apps were combined with nicotine replacement therapy and technical coaching. Inspired by the ORBIT model, we implemented two case studies with crossover AB interventions, two B-phase training designs, and three bi-phasic AB single-case designs with Start-Point and Order randomization (A = QG, B = LTQ). Study outcomes were measured using the System Usability Scale, UX interviews, and background analytics. LTQ's usability levels were above the standard cutoff and on average higher than QG. UX outcomes suggested the relative benefits of LTQ's visual design, gamification and simple design structure. LTQ's overall UE was high; the app was opened for an average of 14 min per day (vs. QG: 7 min). However, users showed low levels of UE with each of the app's tracking feature. Measures of psychiatric functioning suggested the safety of LTQ in people with SMI. LTQ appears to be a usable and engaging smoking cessation app in people with SMI. An optimized version of LTQ should be tested in a Phase II study.",2019,LTQ's usability levels were above the standard cutoff and on average higher than QG.,"['individuals with serious mental illness (SMI', 'people with SMI', 'people with serious mental illness']","['nicotine replacement therapy and technical coaching', 'LTQ']","['System Usability Scale, UX interviews, and background analytics', ""relative benefits of LTQ's visual design, gamification and simple design structure"", ""LTQ's usability levels"", 'usability, user experience (UX), and user engagement (UE) of Learn to Quit (LTQ']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0410951,LTQ's usability levels were above the standard cutoff and on average higher than QG.,"[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vilardaga', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rizo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Kientz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Ziedonis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Hernandez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby097']
2933,30866143,Interobserver agreement on interpretation of conventional dacryocystography and dacryoscintigraphy findings: A retrospective single-centre study.,"IMPORTANCE


This study assesses the interobserver agreement on dacryocystography (DCG) and dacryoscintigraphy (DSG) findings.
BACKGROUND


There are no standard grading criteria to guide the interpretation of conventional DCG and DSG findings and therefore there may be a degree of subjectivity. This study evaluates the level of interobserver agreement in the interpretation of DCG and DSG findings.
DESIGN


A retrospective observational study at the Royal Adelaide Hospital.
PARTICIPANTS


A total of 165 patients who presented with epiphora with 276 DCGs and 290 DSGs performed were included in this study.
METHODS


DCG and DSG images were obtained, anonymized, randomized and interpreted by three independent oculoplastic surgeons. Standard grading criteria were set for both DCG and DSG images. Data from all observers were analysed for interobserver agreement using Kappa (κ) statistics, generated using a variation of Cohen's kappa for multiple observers.
MAIN OUTCOME MEASURES


Level of interobserver agreement (κ values) in the grading of DCG and DSG findings.
RESULTS


There was an overall moderate interobserver agreement for DCG findings (κ = 0.55), with the highest agreement on interpreting canalicular obstruction (κ = 0.80), followed by proximal nasolacrimal duct obstruction (κ = 0.67) and normal patency (κ = 0.63). There was an overall fair interobserver agreement for DSG findings (κ = 0.36), with the best being moderate agreement (κ = 0.42-0.50) for interpreting pre-sac delay and post-sac proximal delay.
CONCLUSIONS AND RELEVANCE


DCG offers good reliability in interpreting patent and obstructed systems. On the other hand, DSG has poor agreement and highlights some of the limitations in the ability to guide epiphora management.",2019,"There was an overall fair interobserver agreement for DSG findings (κ = 0.36), with the best being moderate agreement (κ = 0.42-0.50) for interpreting pre-sac delay and post-sac proximal delay.
",['A total of 165 patients who presented with epiphora with 276 DCGs and 290 DSGs performed were included in this study'],['dacryocystography (DCG) and dacryoscintigraphy (DSG'],"['proximal nasolacrimal duct obstruction', 'normal patency']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0202744', 'cui_str': 'Dacryocystography'}, {'cui': 'C0412346', 'cui_str': 'Radionuclide lacrimal flow study'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C1281931', 'cui_str': 'Obstruction of nasolacrimal duct'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",165.0,0.0567994,"There was an overall fair interobserver agreement for DSG findings (κ = 0.36), with the best being moderate agreement (κ = 0.42-0.50) for interpreting pre-sac delay and post-sac proximal delay.
","[{'ForeName': 'Paul I', 'Initials': 'PI', 'LastName': 'Sia', 'Affiliation': 'South Australian Institute of Ophthalmology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Curragh', 'Affiliation': 'South Australian Institute of Ophthalmology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Data, Design and Statistics Service, Adelaide Health Technology Assessment, School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Selva', 'Affiliation': 'South Australian Institute of Ophthalmology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13502']
2934,32090516,Levels of Circulating miR-122 are Associated with Weight Loss and Metabolic Syndrome.,"OBJECTIVE


This study investigated whether the levels of specific serum microRNAs (miRNAs) were altered following diet-induced weight loss and whether the serum miRNAs differed in the presence of the metabolic syndrome.
METHODS


The study was a weight loss intervention trial with a prescribed energy deficit of approximately 500 kcal/d. Levels of 22 miRNAs were determined in serum samples from 85 participants with overweight or obesity. miRNAs were analyzed using TaqMan Array miRNA Cards and normalized to the geometric mean of spiked-in ath-miR-159a and U6 small nuclear RNA using the ΔC T  method.
RESULTS


The average weight loss was 5.7 kg (P < 0.001). miR-122-5p (-0.18 ± 0.06 log fold relative to initial, P < 0.01) and miR-193a-5p (-0.12 ± 0.04, P < 0.01) levels decreased in response to weight loss. miR-126a-3p (0.11 ± 0.04, P = 0.01) and miR-222-3p (1.51 ± 0.12, P < 0.001) levels increased. Furthermore, a higher level of miR-122-5p was observed at baseline in participants with the metabolic syndrome compared with participants without (0.28 ± 0.08, P < 0.01).
CONCLUSIONS


Changes in circulating miR-122-5p, miR-126a-3p, miR-193a-5p, and miR-222-3p in response to diet-induced weight loss are demonstrated. Furthermore, assessment of miR-122-5p could be an indicator of an adverse metabolic health status independent of obesity.",2020,"miR-122-5p (-0.18 ± 0.06 log fold relative to initial, P < 0.01) and miR-193a-5p (-0.12 ± 0.04, P < 0.01) levels decreased in response to weight loss.",['85 participants with overweight or obesity'],['miR-126a-3p'],['average weight loss'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1101610', 'cui_str': 'MicroRNA'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",85.0,0.0510931,"miR-122-5p (-0.18 ± 0.06 log fold relative to initial, P < 0.01) and miR-193a-5p (-0.12 ± 0.04, P < 0.01) levels decreased in response to weight loss.","[{'ForeName': 'Anne Lundby', 'Initials': 'AL', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Lesli Hingstrup', 'Initials': 'LH', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Pernille Baekgaard', 'Initials': 'PB', 'LastName': 'Udesen', 'Affiliation': 'Department of Science and Environment, Roskilde University, Roskilde, Denmark.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sanz', 'Affiliation': 'Microbial Ecology, Nutrition and Health Research Unit, Institute of Agrochemistry and Food Technology, National Research Council (IATA-CSIC), Valencia, Spain.'}, {'ForeName': 'Thomas Meinert', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Louise Torp', 'Initials': 'LT', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Science and Environment, Roskilde University, Roskilde, Denmark.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22704']
2935,32090511,Association Between Lifestyle and Hypertriglyceridemic Waist Phenotype in the PREDIMED-Plus Study.,"OBJECTIVE


The hypertriglyceridemic waist (HTGW) phenotype is characterized by abdominal obesity and high levels of triglycerides. In a cross-sectional assessment of PREDIMED-Plus trial participants at baseline, HTGW phenotype prevalence was evaluated, associated risk factors were analyzed, and the lifestyle of individuals with metabolic syndrome and HTGW was examined.
METHODS


A total of 6,874 individuals aged 55 to 75 with BMI ≥ 27 and < 40 kg/m 2  were included and classified by presence (HTGW +  ) or absence (HTGW -  ) of HTGW (waist circumference: men ≥ 102 cm, women ≥ 88 cm; fasting plasma triglycerides ≥ 150 mg/dL). Analytical parameters and lifestyle (energy intake and expenditure) were analyzed.
RESULTS


A total of 38.2% of the sample met HTGW +  criteria. HTGW +  individuals tended to be younger, have a greater degree of obesity, be sedentary, and be tobacco users. They had higher peripheral glucose, total cholesterol, and low-density lipoprotein cholesterol levels; had lower high-density lipoprotein cholesterol levels; and had increased prevalence of type 2 diabetes mellitus. Mediterranean diet (MedDiet) adherence and physical activity were greater in HTGW -  patients. Age, BMI, tobacco use, total energy expenditure, hypertension, type 2 diabetes mellitus, and MedDiet adherence were associated with HTGW +  .
CONCLUSIONS


HTGW is a highly prevalent phenotype in this population associated with younger age, higher BMI, tobacco use, and decreased MedDiet adherence. HTGW -  individuals were more physically active with greater total physical activity, and fewer had hypertension.",2020,"They had higher peripheral glucose, total cholesterol, and low-density lipoprotein cholesterol levels; had lower high-density lipoprotein cholesterol levels; and had increased prevalence of type 2 diabetes mellitus.","['6,874 individuals aged 55 to 75 with BMI\u2009≥\u200927 and\u2009<\u200940 kg/m 2  were included and classified by presence (HTGW +  ) or absence (HTGW -  ) of HTGW (waist circumference: men\u2009≥\u2009102 cm, women\u2009≥\u200988 cm; fasting plasma triglycerides\u2009≥\u2009150 mg/dL']",[],"['Analytical parameters and lifestyle (energy intake and expenditure', 'higher peripheral glucose, total cholesterol, and low-density lipoprotein cholesterol levels', 'Mediterranean diet (MedDiet) adherence and physical activity', 'total physical activity', 'Age, BMI, tobacco use, total energy expenditure, hypertension, type 2 diabetes mellitus, and MedDiet adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3658248', 'cui_str': 'Enlarged Waist Elevated Triglycerides'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",6874.0,0.0566702,"They had higher peripheral glucose, total cholesterol, and low-density lipoprotein cholesterol levels; had lower high-density lipoprotein cholesterol levels; and had increased prevalence of type 2 diabetes mellitus.","[{'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Malaga University, Instituto de Investigación Biomédica de Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Muñoz-Garach', 'Affiliation': 'Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Malaga University, Instituto de Investigación Biomédica de Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvado', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Hernáez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García Molina', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José Juan', 'Initials': 'JJ', 'LastName': 'Gaforio', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Matía-Martín', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, IMDEA Food, CEI UAM + CSIC, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martín Sánchez', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Prieto', 'Affiliation': 'Department of Endocrinology, Fundación Jiménez-Díaz, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Goñi', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Babio', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ortega-Azorin', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Konieczna', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Leyre', 'Initials': 'L', 'LastName': 'Notario Barandiaran', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vaquero-Luna', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Benavente-Marín', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'M Angeles', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Sanchez-Villegas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Sacanella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gómez Huelgas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Miró-Moriano', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Gimenez-Gracia', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Julibert', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Razquin', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': 'Departament de Bioquímica i Biotecnologia, Universitat Rovira i Virgili, Unitat de Nutrició, Reus, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Portolés', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday', 'Affiliation': 'University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Aina M', 'Initials': 'AM', 'LastName': 'Galmés-Panadés', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'López-García', 'Affiliation': 'Centro Salud Raval de Elche, Alicante, Spain.'}, {'ForeName': 'Anai', 'Initials': 'A', 'LastName': 'Moreno-Rodriguez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Díaz-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Malaga University, Instituto de Investigación Biomédica de Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'M Rosa', 'Initials': 'MR', 'LastName': 'Bernal-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22728']
2936,32860399,"No independent or combined effects of vitamin D and conjugated linoleic acids on muscle protein synthesis in older adults: a randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


Aging is associated with skeletal muscle anabolic resistance (i.e., reduced muscle protein synthesis during anabolic conditions such as hyperaminoacidemia). The results from studies conducted in cell culture systems and animals suggest that both vitamin D and conjugated linoleic acids (CLAs) stimulate muscle protein synthesis.
OBJECTIVES


To conduct a randomized, double-blind, placebo-controlled clinical trial to determine the independent and combined effects of dietary vitamin D and CLA supplementation on myofibrillar protein synthesis rates in sedentary older adults.
METHODS


Thirty-two sedentary, older adults were randomized to receive either: 1) 2000 IU vitamin D-3 (Vit D) per day; 2) 4000 mg CLA per day; 3) both Vit D (2000 IU/d) and CLA (4000 mg/d); or 4) placebo for 8 wk. Myofibrillar protein synthesis rates were evaluated by using intravenous [ring-2H5]phenylalanine infusion in conjunction with muscle biopsies during basal, postabsorptive conditions and during combined amino acid and insulin infusion before and after the supplementation period.
RESULTS


Before the intervention, basal myofibrillar protein synthesis rates were not different among groups (Placebo: 0.033 ± 0.003; Vit D: 0.034 ± 0.002; CLA: 0.029 ± 0.005; Vit D + CLA: 0.038 ± 0.005 %·h-1), and hyperinsulinemia-hyperaminoacidemia increased myofibrillar protein synthesis rates by ∼35%. Compared with placebo, neither Vit D nor CLA nor combined Vit D + CLA supplementation affected the basal myofibrillar protein synthesis rates (placebo: 0.040 ± 0.004%/h; Vit D: 0.044 ± 0.006%/h; CLA: 0.039 ± 0.006%/h; Vit D + CLA: 0.040 ± 0.007%/h) or the hyperinsulinemia-hyperaminoacidemia-induced increase in myofibrillar protein synthesis (percentage increase from basal before and after the interventions: placebo, 30 ± 11 and 36 ± 11; Vit D, 38 ± 8 and 34 ± 10; CLA, 50 ± 14 and 51 ± 16; Vit D + CLA, 29 ± 15 and 35 ± 8).
CONCLUSIONS


Vitamin D and/or CLA supplementation, at the doses provided in our study, does not have muscle anabolic effects in sedentary older adults.The study was registered at clinicaltrials.gov (NCT03115775).",2020,"Compared with placebo, neither Vit D nor CLA nor combined Vit D + CLA supplementation affected the basal myofibrillar protein synthesis rates (placebo: 0.040 ± 0.004%/h; Vit D: 0.044 ± 0.006%/h; CLA: 0.039 ± 0.006%/h; Vit D + CLA: 0.040 ± 0.007%/h) or the hyperinsulinemia-hyperaminoacidemia-induced increase in myofibrillar protein synthesis (percentage increase from basal before and after the interventions: placebo, 30 ± 11 and 36 ± 11; Vit D, 38 ± 8 and 34 ± 10; CLA, 50 ± 14 and 51 ± 16; Vit D + CLA, 29 ± 15 and 35 ± 8).
","['older adults', 'sedentary older adults', 'Thirty-two sedentary, older adults']","['vitamin D and conjugated linoleic acids (CLAs', 'vitamin D-3 (Vit D) per day', 'dietary vitamin D and CLA supplementation', 'CLA', 'intravenous [ring-2H5]phenylalanine infusion', 'placebo', 'vitamin D and conjugated linoleic acids', 'placebo, neither Vit D nor CLA nor combined Vit D\xa0+\xa0CLA supplementation', 'Vitamin D and/or CLA supplementation', 'Vit D']","['Myofibrillar protein synthesis rates', 'myofibrillar protein synthesis', 'hyperinsulinemia-hyperaminoacidemia increased myofibrillar protein synthesis rates', 'muscle anabolic effects', 'myofibrillar protein synthesis rates', 'basal myofibrillar protein synthesis rates', 'muscle protein synthesis']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3179309', 'cui_str': 'Anabolic Effects'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",32.0,0.40154,"Compared with placebo, neither Vit D nor CLA nor combined Vit D + CLA supplementation affected the basal myofibrillar protein synthesis rates (placebo: 0.040 ± 0.004%/h; Vit D: 0.044 ± 0.006%/h; CLA: 0.039 ± 0.006%/h; Vit D + CLA: 0.040 ± 0.007%/h) or the hyperinsulinemia-hyperaminoacidemia-induced increase in myofibrillar protein synthesis (percentage increase from basal before and after the interventions: placebo, 30 ± 11 and 36 ± 11; Vit D, 38 ± 8 and 34 ± 10; CLA, 50 ± 14 and 51 ± 16; Vit D + CLA, 29 ± 15 and 35 ± 8).
","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'van Vliet', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fappi', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mittendorfer', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa240']
2937,32860406,The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial.,"AIMS 


Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent.
METHODS AND RESULTS 


Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group.
CONCLUSIONS 


Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.",2020,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"['acute myocardial infarction', 'patients following acute myocardial infarction (AMI', '375 patients were recruited: 185 patients', 'patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI']","['Bone marrow-derived mononuclear cell', 'treatment arm (intracoronary infusion of BM-MNCs 2-8\u2009days after PPCI', 'intracoronary infusion of bone marrow-derived mononuclear cells', 'BM-MNC) therapy']","['adverse events nor serious adverse events', 'hospitalized for stroke', 'myocardial recovery', 'heart failure']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",375.0,0.0908235,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernández-Avilés', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': 'Cardiovascular Center, OLV Hospital Aalst, Aalst, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'KU, Leuven, Leuven, Belgium.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Sheik', 'Initials': 'S', 'LastName': 'Dowlut', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Galiñanes', 'Affiliation': ""Department of Cardiac Surgery, Reparative Therapy of the Heart, Vall d'Hebron Research Institute, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Good', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hauskeller', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'University Hospitals (UZ) Leuven, Belgium.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshospitalet and University of Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Menasché', 'Affiliation': 'Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou and University of Paris, Paris, France.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Sanz-Ruiz', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Ylä-Herttuala', 'Affiliation': 'University of Eastern Finland, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa651']
2938,32389220,Quantifying Downstream Healthcare Utilization in Studies of Genomic Testing.,"OBJECTIVES


The challenges of understanding how interventions influence follow-up medical care are magnified during genomic testing because few patients have received it to date and because the scope of information it provides is complex and often unexpected. We tested a novel strategy for quantifying downstream healthcare utilization after genomic testing to more comprehensively and efficiently identify related services. We also evaluated the effectiveness of different methods for collecting these data.
METHODS


We developed a risk-based approach for a trial of newborn genomic sequencing in which we defined primary conditions based on existing diagnoses and family histories of disease and defined secondary conditions based on unexpected findings. We then created patient-specific lists of services associated with managing primary and secondary conditions. Services were quantified based on medical record reviews, surveys, and telephone check-ins with parents.
RESULTS


By focusing on services that genomic testing would most likely influence in the short-term, we reduced the number of services in our analyses by more than 90% compared with analyses of all observed services. We also identified the same services that were ordered in response to unexpected findings as were identified during expert review and by confirming whether recommendations were completed. Data also showed that quantifying healthcare utilization with surveys and telephone check-ins alone would have missed the majority of attributable services.
CONCLUSIONS


Our risk-based strategy provides an improved approach for assessing the short-term impact of genomic testing and other interventions on healthcare utilization while conforming as much as possible to existing best-practice recommendations.",2020,Our risk-based strategy provides an improved approach for assessing the short-term impact of genomic testing and other interventions on healthcare utilization while conforming as much as possible to existing best-practice recommendations.,[],[],['number of services'],[],[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.038462,Our risk-based strategy provides an improved approach for assessing the short-term impact of genomic testing and other interventions on healthcare utilization while conforming as much as possible to existing best-practice recommendations.,"[{'ForeName': 'Zoë P', 'Initials': 'ZP', 'LastName': 'Mackay', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Dukhovny', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'Center for Translational and Policy Research on Personalized Medicine, Department of Clinical Pharmacy, University of California San Francisco, San Francisco, CA, USA; Philip R Lee Institute for Health Policy, University of California San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Beggs', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Broad Institute of the Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA; Partners Healthcare Personalized Medicine, Boston, MA, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Parad', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Pediatric Newborn Medicine, Brigham & Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kurt D', 'Initials': 'KD', 'LastName': 'Christensen', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Broad Institute of the Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA; Precision Medicine Translational Research Center, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: kurt_christensen@harvardpilgrim.org.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.01.017']
2939,32858523,Promoting Physical Activity and Executive Functions Among Children: A Cluster Randomized Controlled Trial of an After-School Program in Australia.,"BACKGROUND


The aim of this study was to examine the efficacy of an embedded after-school intervention, on promoting physical activity and academic achievement in primary-school-aged children.
METHODS


This 6-month, 2-arm cluster randomized controlled trial involved 4 after-school centers. Two centers were randomly assigned to the intervention, which involved training the center staff on and implementing structured physical activity (team sports and physical activity sessions for 75 min) and academic enrichment activities (45 min). The activities were implemented 3 afternoons per week for 2.5 hours. The control centers continued their usual after-school care practice. After-school physical activity (accelerometry) and executive functions (working memory, inhibition, and cognitive flexibility) were assessed pre- and postintervention.
RESULTS


A total of 60 children were assessed (7.7 [1.8] y; 50% girls) preintervention and postintervention (77% retention rate). Children in the intervention centers spent significantly more time in moderate to vigorous physical activity (adjusted difference = 2.4%; 95% confidence interval, 0.6 to 4.2; P = .026) and scored higher on cognitive flexibility (adjusted difference = 1.9 units; 95% confidence interval, 0.9 to 3.0; P = .009). About 92% of the intervention sessions were implemented. The participation rates varied between 51% and 94%.
CONCLUSION


This after-school intervention was successful at increasing moderate to vigorous physical activity and enhancing cognitive flexibility in children. As the intervention was implemented by the center staff and local university students, further testing for effectiveness and scalability in a larger trial is required.",2020,"Children in the intervention centers spent significantly more time in moderate to vigorous physical activity (adjusted difference = 2.4%; 95% confidence interval, 0.6 to 4.2; P = .026) and scored higher on cognitive flexibility (adjusted difference = 1.9 units; 95% confidence interval, 0.9 to 3.0; P = .009).","['4 after-school centers', 'Australia', 'children', 'primary-school-aged children', 'Children', '60 children were assessed (7.7 [1.8']","['intervention, which involved training the center staff on and implementing structured physical activity (team sports and physical activity sessions for 75\xa0min) and academic enrichment activities']","['participation rates', 'time in moderate to vigorous physical activity', 'school physical activity (accelerometry) and executive functions (working memory, inhibition, and cognitive flexibility', 'physical activity and academic achievement', 'cognitive flexibility']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",60.0,0.0721385,"Children in the intervention centers spent significantly more time in moderate to vigorous physical activity (adjusted difference = 2.4%; 95% confidence interval, 0.6 to 4.2; P = .026) and scored higher on cognitive flexibility (adjusted difference = 1.9 units; 95% confidence interval, 0.9 to 3.0; P = .009).","[{'ForeName': 'Sanne L C', 'Initials': 'SLC', 'LastName': 'Veldman', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Stanley', 'Affiliation': ''}, {'ForeName': 'Dylan P', 'Initials': 'DP', 'LastName': 'Cliff', 'Affiliation': ''}, {'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Vella', 'Affiliation': ''}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'Anne-Maree', 'Initials': 'AM', 'LastName': 'Parrish', 'Affiliation': ''}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0381']
2940,32858524,"Effect of Evidence-Based Materials and Access to Local Resources on Physical Activity Levels, Beliefs, and Motivation During Pregnancy in a Rural Setting.","BACKGROUND


The purpose of this study was to determine the impact of evidence-based educational materials and access to local resources on physical activity (PA) levels, beliefs, and motivation (including self-efficacy) regarding PA during pregnancy in a rural setting.
METHODS


Information on PA levels (step counts, Pregnancy Physical Activity Questionnaire) and beliefs and motivation regarding PA (main surveys: Exercise Beliefs Questionnaire, Protection Motivation Theory and Health Action Process Approach) were collected between 8 and 16 weeks gestation. Women from a rural community were randomly assigned to the PA group (PAG, n = 38) or control group (n = 32). The PAG participants received an evidence-based educational brochure and access (at no charge to them) to local fitness facilities. At approximately 34 to 37 weeks gestation, baseline assessments were repeated.
RESULTS


Sedentary time was significantly different between groups over time, with control participants increasing sedentary time and PAG participants decreasing sedentary time (P = .04). Sixteen women (42%) in the PAG utilized the resources provided (prenatal yoga being utilized most). Postintervention, there was a significant group × time interaction for Perceived Self-Efficacy scores; scores in the PAG remained consistent with baseline values, whereas scores in the control group decreased (P = .03).
CONCLUSIONS


The intervention reduced sedentary time and maintained self-efficacy scores during pregnancy.",2020,"RESULTS


Sedentary time was significantly different between groups over time, with control participants increasing sedentary time and PAG participants decreasing sedentary time (P = .04).","['Women from a rural community', 'Sixteen women (42%) in the PAG utilized the resources provided (prenatal yoga being utilized most']",['Evidence-Based Materials and Access to Local Resources'],"['sedentary time', 'Physical Activity Levels, Beliefs, and Motivation', 'sedentary time and maintained self-efficacy scores', 'physical activity (PA) levels, beliefs, and motivation (including self-efficacy', 'time interaction for Perceived Self-Efficacy scores; scores', 'PA levels (step counts, Pregnancy Physical Activity Questionnaire) and beliefs and motivation regarding PA (main surveys: Exercise Beliefs Questionnaire, Protection Motivation Theory and Health Action Process Approach']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",16.0,0.0933832,"RESULTS


Sedentary time was significantly different between groups over time, with control participants increasing sedentary time and PAG participants decreasing sedentary time (P = .04).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tinius', 'Affiliation': ''}, {'ForeName': 'Kolbi', 'Initials': 'K', 'LastName': 'Edens', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Link', 'Affiliation': ''}, {'ForeName': 'M Susan', 'Initials': 'MS', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lyons', 'Affiliation': ''}, {'ForeName': 'Tatum', 'Initials': 'T', 'LastName': 'Rebelle', 'Affiliation': ''}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Pearson', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Maples', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0440']
2941,32858531,The Effects of Nitroglycerin on the Oxytocin Dose-Response Profile in Oxytocin-Desensitized and Naïve Human Myometrium: An In Vitro Study.,"BACKGROUND


Nitroglycerin is used for acute reduction in uterine tone. Prolonged oxytocin exposure causes desensitization of oxytocin receptors. It is unknown if nitroglycerin exposure impacts the subsequent action of oxytocin in the setting of oxytocin receptor desensitization. This study investigated the effects of nitroglycerin on oxytocin-desensitized and oxytocin-naïve human myometrium and the subsequent response to oxytocin dose-response testing in vitro.
METHODS


Myometrial samples from 17 elective cesarean deliveries were divided into strips and allocated to 1 of 4 groups: (1) oxytocin desensitized and no nitroglycerin; (2) oxytocin desensitized and nitroglycerin; (3) oxytocin naïve and nitroglycerin; and (4) oxytocin naïve and no nitroglycerin. Final analysis included 28 strips per group. Nitroglycerin groups were exposed to incremental concentrations of nitroglycerin, while no nitroglycerin groups were kept in control (physiological salt) solution. All groups then underwent oxytocin dose-response testing. Primary outcome was motility index (amplitude × frequency; grams × contractions per 10 minutes [g·c/10 min]). Secondary outcomes were amplitude (g), frequency (contractions/10 minutes), and area under the curve (g·s). All outcomes (nitroglycerin and oxytocin dose-response periods) were expressed as a percentage change from baseline. Values were log transformed, compared using regression modeling and reported as the ratio of 2 geometric means (relative difference).
RESULTS


No significant difference was observed in motility index following nitroglycerin administration in oxytocin-desensitized versus oxytocin-naïve groups (relative difference = 19.0%; 95% confidence interval [CI], -32.6 to 109.9; P = .55). On oxytocin dose-response testing, motility index was highest in oxytocin-naïve and no nitroglycerin samples (group 4) (1.356 g·c/10 minutes) followed by oxytocin-naïve and nitroglycerin (group 3) (0.882 g·c/10 minutes), oxytocin-desensitized and no nitroglycerin (group 1) (0.769 g·c/10 minutes), and oxytocin-desensitized and nitroglycerin (group 2) (0.651 g·c/10 minutes) samples. Motility index was significantly reduced in group 1 vs 4 (relative difference = -43.3%; 95% CI, -66.5 to -4.1; P = .034) and group 2 vs 4 (relative difference = -52.0%; 95% CI, -70.9 to -20.8; P = .004). While in groups 3 vs 4, both amplitude (relative difference = -17.8%; 95% CI, -30.9 to -2.2; P = .27) and area under the curve (AUC; relative difference = -17.5%; 95% CI, -30.7 to -1.8; P = .030) were reduced.
CONCLUSIONS


Nitroglycerin-induced relaxation was not different between oxytocin-desensitized and oxytocin-naïve human myometrial strips in vitro. However, oxytocin-induced contractility was attenuated after nitroglycerin exposure in both oxytocin-desensitized and oxytocin-naïve samples, with maximum attenuation observed in desensitized tissues. This finding warrants further clinical studies to explore uterine responsiveness to oxytocin in women with oxytocin-augmented labors after nitroglycerin administration.",2020,"No significant difference was observed in motility index following nitroglycerin administration in oxytocin-desensitized versus oxytocin-naïve groups (relative difference = 19.0%; 95% confidence interval [CI], -32.6 to 109.9; P = .55).","['Oxytocin-Desensitized and Naïve Human Myometrium', 'women with oxytocin-augmented labors after nitroglycerin administration', 'Myometrial samples from 17 elective cesarean deliveries']","['oxytocin-desensitized and nitroglycerin', 'oxytocin-naïve and nitroglycerin', 'oxytocin-desensitized and no nitroglycerin', 'oxytocin desensitized and no nitroglycerin; (2) oxytocin desensitized and nitroglycerin; (3) oxytocin naïve and nitroglycerin; and (4) oxytocin naïve and no nitroglycerin', 'oxytocin', 'nitroglycerin', 'nitroglycerin, while no nitroglycerin', 'Nitroglycerin']","['motility index', 'motility index (amplitude × frequency; grams × contractions per 10 minutes [g·c/10 min', 'oxytocin-induced contractility', 'Motility index', 'amplitude (g), frequency (contractions/10 minutes), and area under the curve (g·s']","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0027088', 'cui_str': 'Myometrial structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]","[{'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0456692', 'cui_str': '/10 min'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.16411,"No significant difference was observed in motility index following nitroglycerin administration in oxytocin-desensitized versus oxytocin-naïve groups (relative difference = 19.0%; 95% confidence interval [CI], -32.6 to 109.9; P = .55).","[{'ForeName': 'Gayani S', 'Initials': 'GS', 'LastName': 'Jayasooriya', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jose C A', 'Initials': 'JCA', 'LastName': 'Carvalho', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Luca', 'Affiliation': ''}, {'ForeName': 'Mrinalini', 'Initials': 'M', 'LastName': 'Balki', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005055']
2942,32858543,Effect of An Online Physical Activity Promotion Program and Cardiovascular Symptoms Among Asian American Women at Midlife.,"Despite an increasing number of online programs to promote physical activity, they have rarely been evaluated for their effects on cardiovascular symptoms of racial/ethnic minority women at midlife. This study aimed to determine the preliminary efficacy of a newly developed online program for physical activity promotion on cardiovascular symptoms of Asian American midlife women. This study was a pilot repeated-measures randomized controlled trial (pretest/posttest) among 26 Asian American midlife women. The variables were measured using multiple instruments on background features, physical activity, and cardiovascular symptoms at three points of time (baseline, after 1 month, and after 3 months). Linear mixed models were used to analyze the data. The prevalence and severity of cardiovascular symptoms did not show a statistically significant group-time interaction. However, the increase in lifestyle physical activity over time was significant only among the intervention group (Δ = 0.49, P = .016). The results supported the program's preliminary efficacy on lifestyle physical activity for Asian American women at midlife, but not on cardiovascular symptoms.",2020,"However, the increase in lifestyle physical activity over time was significant only among the intervention group (Δ = 0.49, P = .016).","['Asian American women at midlife', 'Asian American Women at Midlife', '26 Asian American midlife women', 'Asian American midlife women']","['Online Physical Activity Promotion Program', 'online program for physical activity promotion']","['prevalence and severity of cardiovascular symptoms', 'lifestyle physical activity', 'background features, physical activity, and cardiovascular symptoms']","[{'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0476270', 'cui_str': 'Cardiovascular symptoms'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.040086,"However, the increase in lifestyle physical activity over time was significant only among the intervention group (Δ = 0.49, P = .016).","[{'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Chee', 'Affiliation': 'Author Affiliations: Emory University, Atlanta, Georgia (Drs Chee, Kim, and Im); Chang Gung University of Science and Technology, Taipei, Taiwan (Dr Tsai); and University of Pennsylvania, Philadelphia (Dr Liu).'}, {'ForeName': 'Sangmi', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hsiu-Min', 'Initials': 'HM', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Jianghong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Eun-Ok', 'Initials': 'EO', 'LastName': 'Im', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000669']
2943,32858573,Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients: A Randomized Controlled Trial.,"INTRODUCTION


Anticoagulation therapy in portal vein thrombosis (PVT) in patients with cirrhosis is still a matter of debate. Therefore, the aim of this work was to evaluate the efficacy and safety of nadroparin calcium-warfarin sequential (NWS) anticoagulation therapy in cirrhotic patients and to find an optimal anticoagulation strategy.
METHODS


Consecutive cirrhotic patients with PVT who have not received anticoagulation therapy were randomly divided into the NWS therapy group (1-month nadroparin calcium by subcutaneous injection followed by 5-month warfarin by oral administration) and control group (no anticoagulation therapy). Overall recanalization rate of PVT and risks of bleeding were evaluated at the sixth month.
RESULTS


Among 64 patients, complete or partial recanalization of PVT was observed in 20/32 NSW therapy group patients vs 11/32 control group patients (62.5% vs 34.4%, P = 0.024), with no statistically significant difference in bleeding rate. Child-Pugh score (P = 0.023), D-dimer < 2.00 μg/mL (P = 0.020), and NWS anticoagulation therapy (P = 0.004) were predictors associated with the recanalization. NWS anticoagulation therapy (P = 0.008) was an independent predicting factor of recanalization. In the NWS therapy group, the Child-Pugh score (P = 0.007) and albumin level (P = 0.004) were improved in the sixth month.
DISCUSSION


NWS anticoagulation therapy was effective and safe in PVT patients with cirrhosis and could increase the level of albumin. NWS therapy is safe and easily accepted.",2020,"Among 64 patients, complete or partial recanalization of PVT was observed in 20/32 NSW therapy group patients vs 11/32 control group patients (62.5% vs 34.4%, P = 0.024), with no statistically significant difference in bleeding rate.","['Consecutive cirrhotic patients with PVT who have not received anticoagulation therapy', 'cirrhotic patients', 'patients with cirrhosis', 'Cirrhotic Patients', 'PVT patients with cirrhosis']","['NWS therapy', 'Nadroparin Calcium-Warfarin Sequential Anticoagulation', 'nadroparin calcium-warfarin sequential (NWS) anticoagulation therapy', 'NWS therapy group (1-month nadroparin calcium by subcutaneous injection followed by 5-month warfarin by oral administration) and control group (no anticoagulation therapy']","['Overall recanalization rate of PVT and risks of bleeding', 'albumin level', 'level of albumin', 'Pugh score', 'Portal Vein Thrombosis', 'Child-Pugh score', 'complete or partial recanalization of PVT', 'bleeding rate']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",64.0,0.0271201,"Among 64 patients, complete or partial recanalization of PVT was observed in 20/32 NSW therapy group patients vs 11/32 control group patients (62.5% vs 34.4%, P = 0.024), with no statistically significant difference in bleeding rate.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, the People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, the People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, the People's Republic of China.""}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, the People's Republic of China.""}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, the People's Republic of China.""}, {'ForeName': 'Baoquan', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': ""Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, the People's Republic of China.""}, {'ForeName': 'Yanjing', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, the People's Republic of China.""}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000228']
2944,32858582,MRI-Guided Focused Ultrasound of Osseous Metastases: Treatment Parameters Associated With Successful Pain Reduction.,"BACKGROUND


A phase 3 multicenter trial demonstrated that magnetic resonance imaging (MRI)-guided focused ultrasound (US) is a safe, noninvasive treatment that alleviated pain from bone metastases. However, outcomes varied among institutions (from 0%-100% treatment success).
PURPOSE


The aim of this study was to identify patient selection, technical treatment, and imaging parameters that predict successful pain relief of osseous metastases after MRI-guided focused US.
MATERIALS AND METHODS


This was a secondary analysis of a phase 3 clinical study that included participants who received MRI-guided focused US treatment for painful osseous metastases. Noncontrast CT was obtained before treatment. T2-weighted and T1-weighted postcontrast MRIs at 1.5 T or 3 T were obtained before, at the time of, and at 3 months after treatment. Numerical Rating Scale pain scores and morphine equivalent daily dose data were obtained over a 3-month follow-up period. At the 3-month endpoint, participants were categorized as pain relief responders or nonresponders based on Numerical Rating Scale and morphine equivalent daily dose data. Demographics, technical parameters, and imaging features associated with pain relief were determined using stepwise univariable and multivariable models. Responder rates between the subgroup of participants with all predictive parameters and that with none of the parameters were compared using Fisher exact test.
RESULTS


The analysis included 99 participants (mean age, 59 ± 14 years; 56 women). The 3 variables that predicted successful pain relief were energy density on the bone surface (EDBS) (P = 0.001), the presence of postprocedural periosteal devascularization (black band, BB+) (P = 0.005), and female sex (P = 0.02). The subgroup of participants with BB+ and EDBS greater than 5 J/mm had a larger decrease in mean pain score (5.2; 95% confidence interval, 4.6-5.8) compared with those without (BB-, EDBS ≤ 5 J/mm) (1.1; 95% confidence interval, 0.8-3.0; P < 0.001). Participants with all 3 predictive variables had a pain relief responder rate of 93% compared with 0% in participants having none of the predictive variables (P < 0.001).
CONCLUSIONS


High EDBS during treatment, postprocedural periosteal devascularization around the tumor site (BB+), and female sex increased the likelihood of pain relief after MRI-guided focused US of osseous metastasis.",2020,"The 3 variables that predicted successful pain relief were energy density on the bone surface (EDBS) (P = 0.001), the presence of postprocedural periosteal devascularization (black band, BB+) (P = 0.005), and female sex (P = 0.02).","['99 participants (mean age, 59 ± 14 years; 56 women', 'for painful osseous metastases']","['magnetic resonance imaging (MRI)-guided focused ultrasound (US', 'MRI-guided focused US treatment', 'MRI-Guided Focused Ultrasound of Osseous Metastases']","['mean pain score', 'pain relief responders or nonresponders based on Numerical Rating Scale and morphine equivalent daily dose data', 'Responder rates', 'Successful Pain Reduction', 'pain relief', 'successful pain relief were energy density on the bone surface (EDBS', 'pain relief responder rate', 'Numerical Rating Scale pain scores', 'presence of postprocedural periosteal devascularization (black band, BB']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0581712', 'cui_str': 'Devascularization - action'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0175723', 'cui_str': 'Band'}]",99.0,0.245183,"The 3 variables that predicted successful pain relief were energy density on the bone surface (EDBS) (P = 0.001), the presence of postprocedural periosteal devascularization (black band, BB+) (P = 0.005), and female sex (P = 0.02).","[{'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Bitton', 'Affiliation': 'From the Department of Radiology, Stanford University, Stanford, CA.'}, {'ForeName': 'Jarrett', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'From the Department of Radiology, Stanford University, Stanford, CA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'LeBlang', 'Affiliation': 'University MRI & Diagnostic Center, Boca Raton, FL.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Napoli', 'Affiliation': 'Department of Radiological Sciences, University of Rome, Rome, Italy.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Butts Pauly', 'Affiliation': 'From the Department of Radiology, Stanford University, Stanford, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hurwitz', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Ghanouni', 'Affiliation': 'From the Department of Radiology, Stanford University, Stanford, CA.'}]",Investigative radiology,['10.1097/RLI.0000000000000721']
2945,32858717,Effects of Massage on Postoperative Pain in Infants With Complex Congenital Heart Disease.,"BACKGROUND


Pain management is an essential component of care for pediatric patients following surgery. Massage reduces self-reported postoperative pain in adults with heart disease but has received little attention in postoperative pediatric patients with complex congenital heart disease (CCHD).
OBJECTIVES


The aim of the study was to evaluate the effectiveness of massage compared to a rest period on postoperative pain scores and physiological responses in infants with CCHD.
METHODS


We used a two-group randomized clinical trial design with a sample of 60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard postoperative care. Group 1 received a daily 30-minute restriction of nonessential caregiving (quiet time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured six times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HRs), respiratory rates (RRs), and oxygen saturations (SpO2) were recorded continuously. Daily averages, pre- and postintervention FLACC scores, and physiological responses were analyzed using descriptive statistics, generalized linear mixed models repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.
RESULTS


Adjusted pain scores were lower for the massage group on all days except Day 7. Overall, there were no group effects on level of pain or differential rate of change in pain. However, the massage group had lower daily pain scores with small to medium effect size differences, largest at Days 4, 5, and 6, and lower average daily HR and RR. There was little difference between groups in SpO2. Infants demonstrated immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing.
DISCUSSION


This study provides beginning evidence that postoperative massage may reduce pain and improve physiological parameters in infants with congenital heart disease. This nonpharmacological adjunct to pain management may provide a particular benefit for this population by reducing demand on the cardiorespiratory system.",2020,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at Days 4, 5, and 6, and lower average daily HR and RR.","['pediatric patients following surgery', 'infants with congenital heart disease', 'postoperative pediatric patients with complex congenital heart disease (CCHD', '60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery', 'Infants With Complex Congenital Heart Disease', 'adults with heart disease', 'infants with CCHD']","['standard postoperative care', 'Fentanyl-equivalent narcotic values', 'Massage', 'daily 30-minute restriction of nonessential caregiving (quiet time), and Group 2 received a daily 30-minute massage']","['Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC', 'Heart rates (HRs), respiratory rates (RRs), and oxygen saturations (SpO2', 'daily pain scores', 'level of pain or differential rate of change in pain', 'Daily averages, pre- and postintervention FLACC scores, and physiological responses', 'Adjusted pain scores', 'postoperative pain scores and physiological responses', 'immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing', 'Pain', 'Postoperative Pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0852710', 'cui_str': 'Oxygen saturation increased'}]",60.0,0.207658,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at Days 4, 5, and 6, and lower average daily HR and RR.","[{'ForeName': 'Tondi M', 'Initials': 'TM', 'LastName': 'Harrison', 'Affiliation': ""Tondi M. Harrison, PhD, RN, FAAN, is Associate Professor, The Ohio State University College of Nursing, Columbus. Roger Brown, PhD, is Professor, University of Wisconsin-Madison School of Nursing. Travis Duffey, LMT, is Licensed Massage Therapist, Nationwide Children's Hospital, Columbus, Ohio. Corrie Frey, LMT, CIMI, CPMT, is Licensed Massage Therapist, Nationwide Children's Hospital, Columbus, Ohio. Jacob Bailey, BSN, RN, is Staff Nurse, COPC Ohio Center for Pediatrics, Dublin. Marliese Dion Nist, PhD, RNC, is Postdoctoral Fellow, The Ohio State University College of Nursing, Columbus, Ohio. Lauren Renner, MSN, RN, CPNP, is APRN Clinical Leader, Nationwide Children's Hospital, Columbus, Ohio. Jill Fitch, MD, is Pediatric Intensivist, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Duffey', 'Affiliation': ''}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Frey', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fitch', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000459']
2946,32858791,"Effectiveness of Health-Led Cognitive Behavioral-Based Group Therapy on Pain, Functional Disability and Psychological Outcomes among Knee Osteoarthritis Patients in Malaysia.","BACKGROUND


Psychosocial interventions for patients with osteoarthritis (OA) of the knee to reduce pain and improve physical and psychological functioning are still lacking in Malaysia.
METHODS


A parallel-group unblinded randomized controlled trial involving 300 patients was conducted in two hospital orthopedics clinics in Malaysia. Patients were randomly assigned to receive cognitive behavioral-based group therapy ( n  = 150) or no further intervention ( n  = 150). The primary outcome was the change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 months. The data collected were analyzed by covariate-adjusted mixed design repeated measures analysis of variance. All analyses were performed under the terms of intention-to-treat.
RESULTS


At 6 months, mean change from baseline in the KOOS knee pain score was 0.6 points (95% CI -1.73 to 2.94) in the control group and 8.9 points (95% CI 6.62 to 11.23) (denoting less knee pain intensity) in the intervention group (significant treatment effect  p  < 0.0001). Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
CONCLUSION


The intervention module delivered by healthcare professionals had a sustained effect on knee OA pain and functionality over 6 months, thereby leading to an overall improvement in psychological well-being, thus benefitting most of the Malaysian knee OA patients.",2020,"Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
","['patients with osteoarthritis (OA', '300 patients was conducted in two hospital orthopedics clinics in Malaysia', 'Knee Osteoarthritis Patients in Malaysia']","['cognitive behavioral-based group therapy ( n  = 150) or no further intervention', 'Health-Led Cognitive Behavioral-Based Group Therapy']","['knee OA pain and functionality', 'ability to cope with depression, anxiety and pain catastrophizing', 'knee pain intensity', 'Pain, Functional Disability and Psychological Outcomes', 'change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS', 'functional ability', 'KOOS knee pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",300.0,0.133232,"Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
","[{'ForeName': 'Chai Nien', 'Initials': 'CN', 'LastName': 'Foo', 'Affiliation': 'Department of Population Medicine, Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Arumugam', 'Affiliation': 'Department of Orthopaedic, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Rampal', 'Initials': 'R', 'LastName': 'Lekhraj', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Munn-Sann', 'Initials': 'MS', 'LastName': 'Lye', 'Affiliation': 'Department of Population Medicine, Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia.'}, {'ForeName': 'Sherina', 'Initials': 'S', 'LastName': 'Mohd-Sidik', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Zubaidah', 'Initials': 'Z', 'LastName': 'Jamil Osman', 'Affiliation': 'Faculty of Allied Health Sciences, Cyberjaya University College of Medical Sciences, Cyberjaya 63000, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17176179']
2947,32858844,Interleukin-6 Gene Expression Changes after a 4-Week Intake of a Multispecies Probiotic in Major Depressive Disorder-Preliminary Results of the PROVIT Study.,"Major depressive disorder (MDD) is a prevalent disease, in which one third of sufferers do not respond to antidepressants. Probiotics have the potential to be well-tolerated and cost-efficient treatment options. However, the molecular pathways of their effects are not fully elucidated yet. Based on previous literature, we assume that probiotics can positively influence inflammatory mechanisms. We aimed at analyzing the effects of probiotics on gene expression of inflammation genes as part of the randomized, placebo-controlled, multispecies probiotics PROVIT study in Graz, Austria. Fasting blood of 61 inpatients with MDD was collected before and after four weeks of probiotic intake or placebo. We analyzed the effects on gene expression of tumor necrosis factor ( TNF ), nuclear factor kappa B subunit 1 ( NFKB1 ) and interleukin-6 ( IL-6 ). In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05). The intervention group showed decreasing  IL-6  gene expression levels while the placebo group showed increasing gene expression levels of  IL-6 . Probiotics could be a useful additional treatment in MDD, due to their anti-inflammatory effects. Results of the current study are promising, but further studies are required to investigate the beneficial effects of probiotic interventions in depressed individuals.",2020,"In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05).",['61 inpatients with MDD'],"['placebo', 'Multispecies Probiotic', 'Probiotics', 'probiotics']","['gene expression levels of  IL-6 ', 'gene expression of tumor necrosis factor ( TNF ), nuclear factor kappa B subunit 1 ( NFKB1 ) and interleukin-6 ( IL-6 ', 'IL-6  gene expression levels']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}]",61.0,0.0611653,"In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05).","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Susanne A', 'Initials': 'SA', 'LastName': 'Bengesser', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Anne-Christin', 'Initials': 'AC', 'LastName': 'Hauschild', 'Affiliation': 'Department of Mathematics & Computer Science, University of Marburg, 35043 Marburg, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Birkl-Töglhofer', 'Affiliation': 'Institute for Pathology, Neuropathology and Molecular Pathology, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Frederike T', 'Initials': 'FT', 'LastName': 'Fellendorf', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Platzer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Färber', 'Affiliation': 'Institute of Psychology, University of Bamberg, 96047 Bamberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Seidl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Lilli-Marie', 'Initials': 'LM', 'LastName': 'Mendel', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Unterweger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lenger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Mörkl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Dalkner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Birner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Queissner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Maget', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pilz', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kohlhammer-Dohr', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Jolana', 'Initials': 'J', 'LastName': 'Wagner-Skacel', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kreuzer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schöggl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Amberger-Otti', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Lahousen', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Leitner-Afschar', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Haybäck', 'Affiliation': 'Institute for Pathology, Neuropathology and Molecular Pathology, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Kapfhammer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Reininghaus', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}]",Nutrients,['10.3390/nu12092575']
2948,32859109,Effects of Progressive Resistance Training on Cognition and IGF-1 Levels in Elder Women Who Live in Areas with High Air Pollution.,"The aim of this study was to determine the effects of a muscular strength programme on the levels of insulin-like growth factor-1 (IGF-1) and cognitive status in elder women with mild cognitive impairment who lived in areas of high air pollution. A total of 157 women participated in the study, distributed in four groups: Active/Clean (AC  n  = 38) and Active/Pollution (AP  n  = 37), who carried out a progressive resistance training programme for 24 months, and Sedentary/Clean (SC  n  = 40) and Sedentary/Pollution (SP  n  = 42). Maximum strength in the upper and lower limbs (1RM), cognition (Mini-Mental Scale Examination (MMSE)) and blood IGF-1 were evaluated. At the beginning of the intervention, there were no differences between the groups in the assessed variables. The active groups which carried out the resistance training programme (AC and AP), registered better results in IGF-1 than the sedentary groups. These differences were statistically significant in AC vs. SC ( p  < 0.01) and AP vs. SC ( p  < 0.05). Regarding MMSE, group AC registered the highest score increases (+8.2%) (significantly better than the other groups), while group SP worsened (-7%) significantly compared to the other three groups. In conclusion, resistance training had a positive effect on IGF-1, while sedentary behaviour and air pollution had a negative effect on cognitive status.",2020,"The active groups which carried out the resistance training programme (AC and AP), registered better results in IGF-1 than the sedentary groups.","['elder women with mild cognitive impairment who lived in areas of high air pollution', 'Who Live in Areas with High Air Pollution', '157 women participated in the study, distributed in four groups', 'Elder Women']","['Progressive Resistance Training', 'Active/Clean (AC  n  = 38) and Active/Pollution (AP  n  = 37), who carried out a progressive resistance training programme for 24 months, and Sedentary/Clean (SC  n  = 40) and Sedentary/Pollution', 'muscular strength programme']","['cognitive status', 'levels of insulin-like growth factor-1 (IGF-1) and cognitive status', 'Maximum strength in the upper and lower limbs (1RM), cognition (Mini-Mental Scale Examination (MMSE)) and blood IGF-1', 'IGF-1, while sedentary behaviour and air pollution', 'Cognition and IGF-1 Levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0392355', 'cui_str': 'Pollution'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}]",157.0,0.0370053,"The active groups which carried out the resistance training programme (AC and AP), registered better results in IGF-1 than the sedentary groups.","[{'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Molina-Sotomayor', 'Affiliation': 'Facultad de Artes y Educación Física, Departamento de Educación Física, Universidad Metropolitana de Ciencias de la Educación, Santiago 8320000, Chile.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Castillo-Quezada', 'Affiliation': 'Facultad de Educación y Ciencias Sociales, Carrera de Educación Física, Universidad Andrés Bello, Concepción 4600000, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Martínez-Salazar', 'Affiliation': 'Facultad de Educación Ciencias Sociales y Humanidades, Departamento de Educación Física, Universidad de La Frontera, Temuco 4780000, Chile.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'González-Orb', 'Affiliation': 'Facultad de Artes y Educación Física, Departamento de Educación Física, Universidad Metropolitana de Ciencias de la Educación, Santiago 8320000, Chile.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Espinoza-Salinas', 'Affiliation': 'Escuela de Kinesiología, Universidad Santo Tomás, Santiago 8320000, Chile.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Gonzalez-Jurado', 'Affiliation': 'Physical Performance and Sports Research Centre, University of Pablo de Olavide, 41013 Sevilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176203']
2949,32859118,Effects of the Preschool-Based Family-Involving DAGIS Intervention Program on Children's Energy Balance-Related Behaviors and Self-Regulation Skills: A Clustered Randomized Controlled Trial.,"The study examines the effects of a preschool-based family-involving multicomponent intervention on children's energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills, and whether the intervention effects differed among children with low or high parental educational level (PEL) backgrounds. The Increased Health and Wellbeing in Preschools (DAGIS) intervention was conducted as a clustered randomized controlled trial, clustered at preschool level, over five months in 2017-2018. Altogether, 802 children aged 3-6 years in age participated. Parents reported children's consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time by a 7-day diary. Physical activity was assessed by a hip-worn accelerometer. Cognitive and emotional SR was reported in a questionnaire by parents. General linear mixed models with and without repeated measures were used as statistical methods. At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL. The improvement in cognitive SR skills among low PEL intervention children differed from low PEL control children, the significance being borderline. The DAGIS multicomponent intervention did not significantly affect children's EBRBs or SR. Further sub-analyses and a comprehensive process evaluation may shed light on the non-significant findings.",2020,"At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL.","['802 children aged 3-6 years in age participated', 'children with low or high parental educational level (PEL) backgrounds']","['Preschool-Based Family-Involving DAGIS Intervention Program', 'preschool-based family-involving multicomponent intervention']","[""Children's Energy Balance-Related Behaviors and Self-Regulation Skills"", 'cognitive SR skills', 'Cognitive and emotional SR', 'Physical activity', 'EBRBs or SR skills', ""children's energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills"", ""children's consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time"", ""children's EBRBs"", ""children's EBRBs or SR""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",802.0,0.028353,"At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL.","[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Ray', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Rejane', 'Initials': 'R', 'LastName': 'Figuereido', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Vepsäläinen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Pajulahti', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Skaffari', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Sainio', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Pauliina', 'Initials': 'P', 'LastName': 'Hiltunen', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Elviira', 'Initials': 'E', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Korkalo', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Sääksjärvi', 'Affiliation': 'Department of Teacher Education, University of Helsinki, P.O. Box 9, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sajaniemi', 'Affiliation': 'Department of Teacher Education, University of Helsinki, P.O. Box 9, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}]",Nutrients,['10.3390/nu12092599']
2950,32859142,"p -Synephrine, the main protoalkaloid of  Citrus aurantium , raises fat oxidation during exercise in elite cyclists.","Purpose:  The aim of this study was to investigate the acute effects of  p -synephrine ingestion on substrate oxidation during exercise in elite cyclists.  Methods:  Fifteen elite cyclists volunteered to participate in a double blind, crossover, randomized and placebo-controlled experimental trial. During two different trials, participants either ingested a placebo (cellulose) or 3 mg/kg of  p -synephrine. After 60 min for substances absorption, participants performed an incremental maximal cycle ergometer test until volitional fatigue (25 W/min). Breath-by-breath gas exchange data was continuously recorded during the entire test to estimate energy expenditure, carbohydrate oxidation, and fat oxidation rates by stoichiometric equations. Heart rate was continuously measured by using a heart rate monitor.  Results:  The ingestion of  p -synephrine had no significant effects on energy expenditure (F=0.71,  P= 0.40) or heart rate (F=0.66,  P= 0.43) during exercise. However, there was a main effect of  p -synephrine to increase the rate of fat oxidation over the placebo (F=5.1,  P= 0.04) and the rate of fat oxidation was higher with  p -synephrine in the following loads: 45±2%, 51±3%, 62±3%, 67±4%, 79±5% and 85±5% of the maximum wattage obtained in the test (all  P <0.05). The ingestion of  p -synephrine did not modify the maximal rate of fat oxidation during the ramp test (mean value; 95%CI = 0.91; 0.79-1.03 vs 1.01; 0.91-1.11 g/min, respectively,  P =0.06) nor the exercise intensity at which maximal fat oxidation was achieved (i.e., Fatmax= 49; 48-53 vs 50; 47-51% Wmax,  P =0.52).  Conclusion:  Acute  p -synephrine ingestion moved the fat oxidation-exercise intensity curve upwards during an incremental cycling test without affecting Fatmax.",2020,"p -synephrine had no significant effects on energy expenditure (F=0.71,  P= 0.40) or heart rate (F=0.66,  P= 0.43) during exercise.","['Fifteen elite cyclists volunteered to participate', 'elite cyclists']","['p -synephrine ingestion', 'placebo', 'placebo (cellulose) or 3 mg/kg of  p -synephrine', 'synephrine ingestion']","['exercise intensity at which maximal fat oxidation', 'substrate oxidation', 'rate of fat oxidation', 'Heart rate', 'heart rate', 'maximal rate of fat oxidation', 'energy expenditure']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0039086', 'cui_str': 'Synephrine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",,0.220604,"p -synephrine had no significant effects on energy expenditure (F=0.71,  P= 0.40) or heart rate (F=0.66,  P= 0.43) during exercise.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Francisco de Vitoria University. Faculty of Education. Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Baltazar-Martins', 'Affiliation': 'Camilo José Cela University. Exercise Physiology Laboratory. Madrid, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Rodríguez', 'Affiliation': 'Sports performance Lab, Reebok Sport Club, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Camilo José Cela University. Exercise Physiology Laboratory. Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Camilo José Cela University. Exercise Physiology Laboratory. Madrid, Spain.'}, {'ForeName': 'Millán', 'Initials': 'M', 'LastName': 'Aguilar-Navarro', 'Affiliation': 'Francisco de Vitoria University. Faculty of Education. Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies. Rey Juan Carlos University.'}]",European journal of sport science,['10.1080/17461391.2020.1817154']
2951,32859143,"Music attenuates a widened central pulse pressure caused by resistance exercise: a randomized, single-blinded, sham-controlled, crossover study.","Increasing central blood pressure is an independent predictor of cardiovascular disease and is an acute effect of high-intensity resistance exercise. It has been shown that classical music suppresses increased peripheral pressure during exercise. We hypothesized that classical music would suppress increased central pressure induced by high-intensity resistance exercise. To confirm this hypothesis, we examined the effect of classical music on central pressure following high-intensity resistance exercise in 18 young men. A randomized, single-blinded, sham-controlled, crossover trial was conducted under parallel experimental conditions on four separate days. The order of experiments was randomized between sham control (seated rest), music (20-min classical music track compilation), resistance exercise (5 sets of 10 repetitions at 75% of 1 repetition maximum), and resistance exercise with music conditions. Aortic pressure was measured in all subjects. No significant interaction between time, music, and resistance exercise was observed for aortic systolic pressure and diastolic pressure. In contrast, aortic pulse pressure showed a significant interaction; that is, aortic pulse pressure significantly widened after resistance exercise, whereas music significantly attenuated this widening. No significant change was observed in aortic pulse pressure in sham control and music conditions. The present findings suggest that music attenuates resistance exercise-induced increase in central pressure.",2020,No significant change was observed in aortic pulse pressure in sham control and music conditions.,['18 young men'],"['sham control (seated rest), music (20-min classical music track compilation), resistance exercise (5 sets of 10 repetitions at 75% of 1 repetition maximum), and resistance exercise with music conditions', 'Music attenuates a widened central pulse pressure caused by resistance exercise', 'classical music']","['Aortic pressure', 'time, music, and resistance exercise', 'aortic systolic pressure and diastolic pressure', 'central pressure', 'peripheral pressure', 'aortic pulse pressure']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C3494282', 'cui_str': 'Aortic Pulse Pressure'}]",18.0,0.249104,No significant change was observed in aortic pulse pressure in sham control and music conditions.,"[{'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Tagawa', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Atsumu', 'Initials': 'A', 'LastName': 'Yokota', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Tomohito', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Japan.'}]",European journal of sport science,['10.1080/17461391.2020.1817153']
2952,32859032,The Low Glutamate Diet Effectively Improves Pain and Other Symptoms of Gulf War Illness.,"Gulf War Illness (GWI) is a multisymptom disorder including widespread chronic pain, fatigue and gastrointestinal problems. The objective of this study was to examine the low glutamate diet as a treatment for GWI. Forty veterans with GWI were recruited from across the US. Outcomes included symptom score, myalgic score, tender point count, dolorimetry and the Chalder Fatigue Scale. Subjects were randomized to the low glutamate diet or a wait-listed control group, with symptom score being compared after one month. Subjects then went onto a double-blind, placebo-controlled crossover challenge with monosodium glutamate (MSG)/placebo to test for return of symptoms. Symptom score was compared between diet intervention and wait-listed controls with an independent t-test and effect size was calculated with Cohen's  d . Change scores were analyzed with Wilcoxon Signed Rank tests. Crossover challenge results were analyzed with General Linear Models and cluster analysis. The diet intervention group reported significantly less symptoms ( p  = 0.0009) than wait-listed controls, with a very large effect size,  d  = 1.16. Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet. Challenge with MSG/placebo resulted in significant variability in individual response. These results suggest that the low glutamate diet can effectively reduce overall symptoms, pain and fatigue in GWI, but differential results upon challenge suggest that other aspects of the diet, or underlying differences within the population, may be driving these changes. Future research is needed to identify potential nutrient effects, biomarkers, and underlying metabolic differences between responders and non-responders.",2020,"Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet.",['Forty veterans with GWI'],"['low glutamate diet or a wait-listed control', 'placebo', 'MSG/placebo', 'monosodium glutamate (MSG)/placebo']","['individual response', 'overall symptoms, pain and fatigue in GWI', 'symptom score, tender point number, myalgic score and the Chalder Fatigue Scale', 'average dolorimetry', 'symptom score, myalgic score, tender point count, dolorimetry and the Chalder Fatigue Scale', 'symptoms', 'Symptom score']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",40.0,0.0335282,"Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet.","[{'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Holton', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kirkland', 'Affiliation': 'Program in Behavior, Cognition and Neuroscience, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baron', 'Affiliation': 'Department of Mathematics & Statistics, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Shalini S', 'Initials': 'SS', 'LastName': 'Ramachandra', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Mackenzie T', 'Initials': 'MT', 'LastName': 'Langan', 'Affiliation': 'Neuroscience Program, Department of Biology, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Brandley', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Baraniuk', 'Affiliation': 'Department of Medicine, Georgetown University, Washington, DC 20057, USA.'}]",Nutrients,['10.3390/nu12092593']
2953,32859100,Efficacy of a Multi-component m-Health Weight-loss Intervention in Overweight and Obese Adults: A Randomised Controlled Trial.,"BACKGROUND


This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health.
METHODS


Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants ( n  = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups.
RESULTS


Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = -0.92, (95% CI -3.33, 1.48)) or 12 months (0.00, (95% CI -2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (-1.08, (-1.86, -0.29)). No other significant differences were observed between groups.
CONCLUSIONS


Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.",2020,"Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)).","['Nineteen participants (16.4%) formally withdrew from the trial', 'Overweight and Obese Adults', 'Participants ( n  = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5']","['physical activity, diet, sleep, Traditional: physical activity, diet, Control', 'Multi-component m-Health Weight-loss Intervention']","['sedentary time', 'weight loss', 'resistance training', 'bed time variability', 'cardiovascular risk factors, lifestyle behaviours, and mental health', 'physical activity, diet and sleep', 'insomnia symptoms', 'waist circumferences', 'body weight but improved resistance training, and reduced energy intake and insomnia symptom severity', 'reduced energy intake', 'average body weight']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",116.0,0.093777,"Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)).","[{'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Fenton', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, QLD 4067, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre, Central Clinical School, The University of Sydney, 94 Mallett St, Camperdown, NSW 2050, Australia.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Kolt', 'Affiliation': 'School of Health Sciences, Western Sydney University, Penrith, NSW 2751, Australia.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Holliday', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Murawski', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Charles Perkins Centre, Faculty of Medicine and Health, School of Health Sciences, Sydney 2006, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, Appleton Institute, School of Health, Medical and Applied Science, Central Queensland University, Rockhampton, QLD 4700, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17176200']
2954,32859145,"Acute effects of caffeine supplementation on resistance exercise, jumping, and Wingate performance: no influence of habitual caffeine intake.","This study explored the influence of habitual caffeine intake on the acute effects of caffeine ingestion on resistance exercise, jumping, and Wingate performance. Twenty-four resistance-trained males were tested following the ingestion of caffeine (3 mg/kg) and placebo (3 mg/kg of dextrose). Participants were classified as low caffeine users ( n  = 13; habitual caffeine intake: 65 ± 46 mg/day) and as moderate-to-high caffeine users ( n  = 11; habitual caffeine intake: 235 ± 82 mg/day). Exercise performance was evaluated by measuring: (a) movement velocity, power, and muscular endurance in the bench press; (b) countermovement jump; and, (c) a Wingate test, performed in that order. Two-way repeated-measures ANOVA revealed a significant main effect ( p <0.05) for condition in the majority of analyzed exercise outcomes. In all cases, effect sizes for condition favored caffeine and ranged from 0.14-0.97. Mean increases in velocity and power in resistance exercise ranged from 0.02-0.08 m/s and 42-156 W, respectively. The number of performed repetitions increased by 1.2 and jump height by 0.9 cm. Increases in power in the Wingate test ranged from 31-75 W. We did not find significant group × condition interaction effect ( p >0.05) in any of the analyzed exercise outcomes. Additionally, there were no significant correlations ( p >0.05;  r  ranged from -0.29 to 0.32) between habitual caffeine intake and the absolute change in exercise performance. These results suggest that habitual caffeine intake might not moderate the ergogenic effects of acute caffeine supplementation on resistance exercise, jumping, and Wingate performance.",2020,Increases in power in the Wingate test ranged from 31-75 W. We did not find significant group × condition interaction effect ( p >0.05) in any of the analyzed exercise outcomes.,"['Twenty-four resistance-trained males', 'Participants were classified as low caffeine users ( n  = 13; habitual caffeine intake: 65 ± 46 mg/day) and as moderate-to-high caffeine users ( n  = 11; habitual caffeine intake: 235 ± 82 mg/day']","['habitual caffeine intake', 'caffeine', 'placebo', 'caffeine ingestion', 'caffeine supplementation']","['resistance exercise, jumping, and Wingate performance', 'exercise performance', 'measuring: (a) movement velocity, power, and muscular endurance', 'condition interaction effect', 'velocity and power in resistance exercise', 'Exercise performance', 'number of performed repetitions']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3532939', 'cui_str': 'Caffeine user'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0861097', 'cui_str': 'Caffeine increased'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.049006,Increases in power in the Wingate test ranged from 31-75 W. We did not find significant group × condition interaction effect ( p >0.05) in any of the analyzed exercise outcomes.,"[{'ForeName': 'Jozo', 'Initials': 'J', 'LastName': 'Grgic', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'Pavle', 'Initials': 'P', 'LastName': 'Mikulic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}]",European journal of sport science,['10.1080/17461391.2020.1817155']
2955,32859156,Rationale and protocol of the StayFitLonger study: a multicentre trial to measure efficacy and adherence of a home-based computerised multidomain intervention in healthy older adults.,"BACKGROUND


In older adults, multidomain training that includes physical and cognitive activities has been associated with improvement of physical and cognitive health. The goal of the multisite StayFitLonger study is to assess a home-based computerised training programme, which combines physical exercises, stimulating cognitive activities and virtual coaching.
METHODS


One hundred twenty-eight cognitively healthy older adults will be recruited from the community in Switzerland, Canada and Belgium. The study will comprise (1) a 26-week double-blind randomized controlled efficacy trial and (2) a 22-week pragmatic adherence sub-study. In the efficacy trial, participants will be randomly assigned to an experimental or an active control intervention. In the experimental intervention, participants will use the StayFitLonger programme, which is computerised on a tablet and provides content that combines physical activities with a focus on strength and balance, as well as divided attention, problem solving and memory training. Outcomes will be measured before and after 26 weeks of training. The primary efficacy outcome will be performance on the ""Timed-Up & Go"" test. Secondary outcomes will include measures of frailty, cognition, mood, fear of falling, quality of life, and activities of daily living. Age, sex, education, baseline cognition, expectation, and adherence will be used as moderators of efficacy. Following the 26-week efficacy trial, all participants will use the experimental programme meaning that participants in the control group will 'cross over' to receive the StayFitLonger programme for 22 weeks. Adherence will be measured in both groups based on dose, volume and frequency of use. In addition, participants' perception of the programme and its functionalities will be characterised through usability, acceptability and user experience.
DISCUSSION


This study will determine the efficacy, adherence and participants' perception of a home-based multidomain intervention programme and its functionalities. This will allow for further development and possible commercialization of a scientifically validated training programme.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT04237519 Registered on January 22, 2020 - Retrospectively registered.",2020,"Secondary outcomes will include measures of frailty, cognition, mood, fear of falling, quality of life, and activities of daily living.","['older adults', 'One hundred twenty-eight cognitively healthy older adults will be recruited from the community in Switzerland, Canada and Belgium', 'healthy older adults']","['multidomain training', 'home-based computerised multidomain intervention', 'active control intervention']","['performance on the ""Timed-Up & Go"" test', 'measures of frailty, cognition, mood, fear of falling, quality of life, and activities of daily living']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",128.0,0.0513254,"Secondary outcomes will include measures of frailty, cognition, mood, fear of falling, quality of life, and activities of daily living.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Belleville', 'Affiliation': ""Research Centre, Institut universitaire de gériatrie de Montréal, CIUSSS du Centre-Sud-de-l'Île-de-Montréal, 4565, Chemin Queen-Mary, Montréal, Québec, H3W 1W5, Canada. sylvie.belleville@umontreal.ca.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cuesta', 'Affiliation': ""Research Centre, Institut universitaire de gériatrie de Montréal, CIUSSS du Centre-Sud-de-l'Île-de-Montréal, 4565, Chemin Queen-Mary, Montréal, Québec, H3W 1W5, Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bieler-Aeschlimann', 'Affiliation': 'Leenaards Memory Centre, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Giacomino', 'Affiliation': 'HES-SO Valais-Wallis, School of Health Sciences, Loèche-les-Bains, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Widmer', 'Affiliation': 'HES-SO Valais-Wallis, School of Managment, Sierre, Switzerland.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Mittaz Hager', 'Affiliation': 'HES-SO Valais-Wallis, School of Health Sciences, Loèche-les-Bains, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Perez-Marcos', 'Affiliation': 'MindMaze SA, Lausanne, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cardin', 'Affiliation': 'MindMaze SA, Lausanne, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Boller', 'Affiliation': ""Research Centre, Institut universitaire de gériatrie de Montréal, CIUSSS du Centre-Sud-de-l'Île-de-Montréal, 4565, Chemin Queen-Mary, Montréal, Québec, H3W 1W5, Canada.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bier', 'Affiliation': ""Research Centre, Institut universitaire de gériatrie de Montréal, CIUSSS du Centre-Sud-de-l'Île-de-Montréal, 4565, Chemin Queen-Mary, Montréal, Québec, H3W 1W5, Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aubertin-Leheudre', 'Affiliation': ""Research Centre, Institut universitaire de gériatrie de Montréal, CIUSSS du Centre-Sud-de-l'Île-de-Montréal, 4565, Chemin Queen-Mary, Montréal, Québec, H3W 1W5, Canada.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': ""Research Centre, Institut universitaire de gériatrie de Montréal, CIUSSS du Centre-Sud-de-l'Île-de-Montréal, 4565, Chemin Queen-Mary, Montréal, Québec, H3W 1W5, Canada.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Berryman', 'Affiliation': ""Research Centre, Institut universitaire de gériatrie de Montréal, CIUSSS du Centre-Sud-de-l'Île-de-Montréal, 4565, Chemin Queen-Mary, Montréal, Québec, H3W 1W5, Canada.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrigoroaei', 'Affiliation': 'Psychological Sciences Research Institute, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Demonet', 'Affiliation': 'Leenaards Memory Centre, University Hospital of Lausanne, Lausanne, Switzerland.'}]",BMC geriatrics,['10.1186/s12877-020-01709-2']
2956,32859157,Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol.,"BACKGROUND


After kidney transplantation non-adherence and inadequate self-management undermine clinical outcomes and quality of life. Both have been demonstrated to be substantial in all age groups. However, interventions promoting adherence and self-management among kidney transplant recipients that have proven to be effective are scarce. In this study we aim to develop and test an intervention to optimize adherence and self-management. In this article we describe the background and design of the trial entitled 'promoting Medication AdheRence and Self-management among kidney transplant recipients' (MARS-trial)'.
METHODS/DESIGN


This is a single-center, parallel arm randomized controlled trial. Nonadherent kidney transplant recipients aged 12 years or older are eligible for inclusion. Patients will be randomly assigned to either the experimental or a control group. The control group will receive care-as-usual. The experimental group will receive care-as-usual plus the MARS-intervention. The MARS-intervention is an outreaching intervention, based on the principles of (multi) systemic therapy which means involving the social network. A standardized intervention protocol is used for consistency but we will tailor the behavior change techniques used to the specific needs and determinants of each patient. The primary outcome of medication adherence will be measured using electronic monitoring. Secondary outcome measures regarding medication adherence and self-management are also assessed. Data is collected at baseline (T0), after a run-in period (T1), at six months post-baseline/end of treatment (T2) and after a six month follow-up period (T3).
DISCUSSION


We combined elements of (multi) systemic therapy and evidence-based behavior change techniques to create an outreaching and highly individualized intervention. In this trial we will investigate the impact on medication adherence and self-management after kidney transplantation.
TRIAL REGISTRATION


Netherlands Trial Register,trial number NTR7462. Registered 7th September 2018, https://www.trialregister.nl/trial/7264.",2020,"The MARS-intervention is an outreaching intervention, based on the principles of (multi) systemic therapy which means involving the social network.","[""kidney transplant recipients' (MARS-trial"", 'kidney transplant recipients with care-as-usual', 'Nonadherent kidney transplant recipients aged 12\u2009years or older are eligible for inclusion', 'kidney transplant recipients']","['home-based (multi) systemic intervention', 'care-as-usual plus the MARS-intervention']","['medication adherence and self-management', 'medication adherence']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",,0.117896,"The MARS-intervention is an outreaching intervention, based on the principles of (multi) systemic therapy which means involving the social network.","[{'ForeName': 'Denise Karin', 'Initials': 'DK', 'LastName': 'Beck', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands. d.beck@erasmusmc.nl.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Tielen', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Rechards', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Medical Psychology and Psychotherapy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Boonstra', 'Affiliation': 'Department of Medical Psychology and Psychotherapy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Josette', 'Initials': 'J', 'LastName': 'Versteegh', 'Affiliation': ""Department of Pediatric Nephrology, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, Netherlands.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'van de Wetering', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zietse', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Weimar', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van Saase', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van Busschbach', 'Affiliation': 'Department of Medical Psychology and Psychotherapy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Emma Kay', 'Initials': 'EK', 'LastName': 'Massey', 'Affiliation': 'Department of Internal Medicine - Section Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015, Rotterdam, GD, Netherlands.'}]",BMC nephrology,['10.1186/s12882-020-02008-z']
2957,32859177,Cost-effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression - a cluster-randomized trial.,"BACKGROUND


Depression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped care model based on the German National Clinical Practice Guideline ""Unipolar Depression"" has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus treatment as usual in depression.
METHODS


This prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12 months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D-3L as effect measure. Resource utilization was assessed by patient questionnaires. Missing values were imputed by 'multiple imputation using chained equations' based on predictive mean matching. We calculated adjusted group differences in costs and effects as well as incremental cost-effectiveness ratios. To describe the statistical and decision uncertainty cost-effectiveness acceptability curves were constructed based on net-benefit regressions with bootstrapped standard errors (1000 replications). The complete sample and subgroups based on depression severity were considered.
RESULTS


We found no statically significant differences in costs and effects between IG and CG. The incremental total societal costs (+€5016; 95%-CI: [-€259;€10,290) and effects (+ 0.008 QALY; 95%-CI: [- 0.030; 0.046]) were higher in the IG in comparison to the CG. Significantly higher costs were found in the IG for outpatient physician services and psychiatrist services in comparison to the CG. Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression. Incremental cost-effectiveness ratios for the IG in comparison to the CG were unfavourable (complete sample: €627.000/QALY gained; mild depression: dominated; moderately severe depression: €645.154/QALY gained; severe depression: €2082,714/QALY gained) and the probability of cost-effectiveness of the intervention was low, except for the group with moderate depression (ICER: dominance; 70% for willingness-to-pay threshold of €50,000/QALY gained).
CONCLUSIONS


We found no evidence for cost-effectiveness of the intervention in comparison to treatment as usual.
TRIAL REGISTRATION


NCT, NCT01731717 . Registered 22 November 2012 - Retrospectively registered.",2020,Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression.,"['737 depressive adult patients', 'patients with depression - a cluster-randomized trial', 'Registered 22 November 2012 - Retrospectively registered']","['guideline-based stepped and collaborative care', 'control group (CG']","['cost-effectiveness', 'Incremental cost-effectiveness ratios', 'costs and effects', 'Cost-effectiveness', 'quality-adjusted life years (QALY', 'incremental total societal costs', 'total costs and productivity losses', 'incremental cost-effectiveness ratios', 'Resource utilization']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",737.0,0.107628,Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brettschneider', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20251, Hamburg, Germany. c.brettschneider@uke.de.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20251, Hamburg, Germany.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Steinmann', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20251, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20251, Hamburg, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Watzke', 'Affiliation': 'Institute of Psychology, Clinical Psychology and Psychotherapy Research, University of Zurich, Binzmühlestrasse 14, Box 16, CH-8050, Zürich, Switzerland.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20251, Hamburg, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02829-0']
2958,32859445,Comparison of effects of baby shampoo vs. saline irrigation on endoscopic sinus surgery outcomes and quality of life.,"OBJECTIVE


Nasal irrigation is an important step of functional endoscopic sinus surgery (FESS) postoperative care. This study was performed to compare the effects of diluted baby shampoo (BS) and normal saline solution (NSS) irrigation on patients' quality of life (QoL) and surgical outcomes after FESS.
METHODS


This study included 77 patients who underwent FESS to treat chronic rhinosinusitis with nasal polyps. Lund-Mackay score, Lund-Kennedy endoscopic score (LKES), synechia score and QoL (using the Sinonasal Outcome Test (SNOT-22)) were evaluated.
RESULTS


LKES was significantly better in the BS group (p=0.001), especially in terms of nasal discharge and crust formation (p=0.024 and p=0.030, respectively) at 1 month postoperatively. However, no significant difference was found at 3, 6 or 12 months postoperatively (p=0.833, p=0.263, and p=0.346, respectively). The reduction of SNOT-22 score (between preoperative assessment and 1 month postoperatively) was significantly better in the BS than in the NSS group (p=0.025). However, no statistically significant differences were found between groups at 3, 6, or 12 months postoperatively (p=0.312, p=0.280, and p=0.285, respectively). In the evaluation of SNOT-22 subdomains, changes in psychological, rhinological and extranasal rhinological subdomains were significantly better in the BS group at 1 month postoperatively (p=0.019, p=0.010 and p=0.002, respectively).
CONCLUSION


Compared to irrigation with NSS, BS usage following FESS led to reductions of crusting, nasal discharge and synechia formation; moreover, it was associated with improved SNOT-22 scores, especially in psychological, rhinological and extranasal rhinological subdomains.",2020,The reduction of SNOT-22 score (between preoperative assessment and 1 month postoperatively) was significantly better in the BS than in the NSS group (p=0.025).,['77 patients who underwent FESS to treat chronic rhinosinusitis with nasal polyps'],"['FESS', 'baby shampoo vs. saline irrigation', 'diluted baby shampoo (BS) and normal saline solution (NSS) irrigation']","['SNOT-22 scores', 'endoscopic sinus surgery outcomes and quality of life', 'Lund-Mackay score, Lund-Kennedy endoscopic score (LKES), synechia score and QoL (using the Sinonasal Outcome Test (SNOT-22', 'psychological, rhinological and extranasal rhinological subdomains', 'crusting, nasal discharge and synechia formation', 'nasal discharge and crust formation', ""patients' quality of life (QoL) and surgical outcomes"", 'reduction of SNOT-22 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150765', 'cui_str': 'Shampoo'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0154933', 'cui_str': 'Adhesions of iris'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",77.0,0.0273264,The reduction of SNOT-22 score (between preoperative assessment and 1 month postoperatively) was significantly better in the BS than in the NSS group (p=0.025).,"[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: ktulaci@gmail.com.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: drarslanerhan@hotmail.com.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: tugbatulaci@gmail.com.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: hsmtyzc@yahoo.com.tr.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.08.009']
2959,32859487,Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery.,"OBJECTIVE


To determine the efficacy of pectointercostal fascial block in relieving postoperative pain in patients undergoing cardiac surgery.
DESIGN


Single-blinded, prospective, randomized controlled trial.
SETTING


Single-center tertiary care teaching hospital.
PARTICIPANTS


A total 40 participants undergoing cardiac surgery aged 18 to 80 years.
INTERVENTIONS


Subjects were categorized into 2 groups of 20 each. In group 2 participants (interventional group), bilateral pectointercostal fascial block was given using ropivacaine injection 0.25% after completion of surgery, before shifting to the intensive care unit.
MEASUREMENTS AND MAIN RESULTS


Postoperative pain was measured after extubation at 0, 3, 6, and 12 hours, using a numeric rating scale. Pain in group 2 was significantly less and lasted for a longer duration than in group 1. Fentanyl requirement was significantly higher in group 1 (1.06 ± 0.12 µ/kg) than in group 2 (0.82 ± 0.19 µ/kg).
CONCLUSIONS


Pectointercostal fascial block is an easy and efficient technique to reduce postoperative pain after cardiac surgery.",2020,"Fentanyl requirement was significantly higher in group 1 (1.06 ± 0.12 µ/kg) than in group 2 (0.82 ± 0.19 µ/kg).
","['Single-center tertiary care teaching hospital', 'A total 40 participants undergoing cardiac surgery aged 18 to 80 years', 'patients undergoing cardiac surgery', 'Patients Undergoing Cardiac Surgery']","['pectointercostal fascial block', 'ropivacaine injection', 'Pectointercostal Fascial Block (PIFB', 'bilateral pectointercostal fascial block']","['postoperative pain', 'Fentanyl requirement', 'Postoperative pain', 'Pain']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4080371', 'cui_str': 'ropivacaine Injection'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.137109,"Fentanyl requirement was significantly higher in group 1 (1.06 ± 0.12 µ/kg) than in group 2 (0.82 ± 0.19 µ/kg).
","[{'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiac Anesthesiology, CN Center, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ashok.medickaramsi@gmail.com.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Chauhan', 'Affiliation': 'Department of Cardiac Anesthesiology, CN Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Debesh', 'Initials': 'D', 'LastName': 'Bhoi', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Brajesh', 'Initials': 'B', 'LastName': 'Kaushal', 'Affiliation': 'Department of Cardiac Anesthesiology, CN Center, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.07.074']
2960,32859522,Identifying ActiGraph non-wear time in pregnant women with overweight or obesity.,"OBJECTIVES


Non-wear time algorithms have not been validated in pregnant women with overweight/obesity (PW-OW/OB), potentially leading to misclassification of sedentary/activity data, and inaccurate estimates of how physical activity is associated with pregnancy outcomes. We examined: (1) validity/reliability of non-wear time algorithms in PW-OW/OB by comparing wear time from five algorithms to a self-report criterion and (2) whether these algorithms over- or underestimated sedentary behaviors.
DESIGN


PW-OW/OB (N = 19) from the Healthy Mom Zone randomized controlled trial wore an ActiGraph GT3x + for 7 consecutive days between 8-12 weeks gestation.
METHODS


Non-wear algorithms (i.e., consecutive strings of zero acceleration in 60-second epochs) were tested at 60, 90, 120, 150, and 180-min. The monitor registered sedentary minutes as activity counts 0-99. Women completed daily self-report logs to report wear time.
RESULTS


Intraclass correlation coefficients for each algorithm were 0.96-0.97; Bland-Altman plots revealed no bias; mean absolute percent errors were <10%. Compared to self-report (M = 829.5, SD = 62.1), equivalency testing revealed algorithm wear times (min/day) were equivalent: 60- (M = 816.4, SD = 58.4), 90- (M = 827.5, SD = 61.4), 120- (M = 830.8, SD = 65.2), 150- (M = 833.8, SD = 64.6) and 180-min (M = 837.4, SD = 65.4). Repeated measures ANOVA showed 60- and 90-min algorithms may underestimate sedentary minutes compared to 150- and 180-min algorithms.
CONCLUSIONS


The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB. However, implementing algorithms with a higher threshold for consecutive zero counts (i.e., ≥150-min) can avoid the risk of misclassifying sedentary data.",2020,"The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB.","['pregnant women with overweight or obesity', 'pregnant women with overweight/obesity (PW-OW/OB']",['ActiGraph GT3x'],['daily self-report logs to report wear time'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0416337,"The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB.","[{'ForeName': 'Krista S', 'Initials': 'KS', 'LastName': 'Leonard', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Pauley', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Department of Nutritional Sciences and Center for Childhood Obesity Research, The Pennsylvania State University, United States.'}, {'ForeName': 'Penghong', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'School for Engineering of Matter, Transport, and Energy, Arizona State University, United States.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Rivera', 'Affiliation': 'School for Engineering of Matter, Transport, and Energy, Arizona State University, United States.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Department of Nutritional Sciences and Center for Childhood Obesity Research, The Pennsylvania State University, United States.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Symons Downs', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States; Department of OBGYN, College of Medicine, The Pennsylvania State University, United States. Electronic address: dsd11@psu.edu.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.08.003']
2961,32859542,The effect of intermittent diet and/or physical therapy in patients with chronic low back pain: A single-blinded randomized controlled trial.,"BACKGROUND AND PURPOSE


This study aimed to investigate the effect of intermittent diet and/or physical therapy in patients with chronic low back pain.
MATERIALS AND METHODS


Sixty sedentary volunteers with chronic low back pain participated in the study. Body weight and body mass index (BMI) were measured. Pain severity was assessed using Visual Analogue Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), while assessment of disability was done using Barthel Index (BI).
RESULTS


The weight and BMI were reduced after treatment with diet only and diet plus physical therapy (p < 0.001). The pain severity was reduced in all the treated groups (p < 0.001), while BI was increased in the group treated with only physical therapy (p < 0.001).
CONCLUSION


The present study indicated that intermittent diet and/or physical therapy are beneficial to patients with chronic low back pain in terms of pain sensation and daily activities.",2020,"The pain severity was reduced in all the treated groups (p < 0.001), while BI was increased in the group treated with only physical therapy (p < 0.001).
","['Sixty sedentary volunteers with chronic low back pain participated in the study', 'patients with chronic low back pain', 'patients with chronic low back pain in terms of pain sensation and daily activities']",['intermittent diet and/or physical therapy'],"['Visual Analogue Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), while assessment of disability was done using Barthel Index (BI', 'weight and BMI', 'Body weight and body mass index (BMI', 'pain severity', 'Pain severity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",60.0,0.0540141,"The pain severity was reduced in all the treated groups (p < 0.001), while BI was increased in the group treated with only physical therapy (p < 0.001).
","[{'ForeName': 'Mustafa S', 'Initials': 'MS', 'LastName': 'Torlak', 'Affiliation': 'Vocational School of Health Services, Department of Physical Therapy, KTO Karatay University, Karatay, Konya, Turkey. Electronic address: mustafa.savas.torlak@karatay.edu.tr.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Bagcaci', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Konya Medicana Hospital, Selcuklu, Konya, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Akpinar', 'Affiliation': 'Department oF Nerve and Brain Surgery, Konya Medicana Hospital, Selcuklu, Konya, Turkey.'}, {'ForeName': 'Ozerk', 'Initials': 'O', 'LastName': 'Okutan', 'Affiliation': 'Department oF Nerve and Brain Surgery, Konya Medicana Hospital, Selcuklu, Konya, Turkey.'}, {'ForeName': 'Merve S', 'Initials': 'MS', 'LastName': 'Nazli', 'Affiliation': 'Department of Diet, Konya Medicana Hospital, Selcuklu, Konya, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Kuccukturk', 'Affiliation': 'Department of Sleep Disorder, Meram, Konya Necmettin Erbakan University, Konya, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.08.003']
2962,32859616,Changes in Dietary Inflammatory Index Patterns with Weight Loss in Women: A Randomized Controlled Trial.,"Dietary composition can influence systemic inflammation; higher levels of circulating inflammatory biomarkers are associated with increased risk of breast and other cancers. A total of 438 overweight/obese, healthy, postmenopausal women were randomized to a caloric-restriction diet (goal: 10% weight-loss), aerobic-exercise (225 min/week moderate-to-vigorous activity), combined diet+exercise, or control. Dietary inflammatory index (DII®) and energy-adjusted (E-DIITM) scores were derived from food frequency questionnaires (FFQ) and could be calculated for 365 participants with complete FFQs at baseline and 12-months. Changes from baseline to 12-months in E-DII scores in the intervention arms vs. controls were analyzed using generalized estimating equations, adjusted for confounders. We examined associations between changes in previously measured biomarkers and E-DII at 12-months. Participants randomized to diet and diet+exercise arms had greater reductions in E-DII (-104.4% and -84.4%), vs. controls (-34.8%, both P<0.001). Weight change had a more marked effect than E-DII change on biomarkers at 12-months; associations between E-DII and biomarker changes were reduced after adjustment by weight change. Changes in E-DII at 12-months, adjusted for weight change, were negatively associated with changes in ghrelin (r=-0.19 P=0.05 (diet), r=-0.29 P=0.02 (diet+exercise)), and positively with vascular endothelial growth factor (VEGF; r=0.22 P=0.03, (diet+exercise)), and red blood cell counts (r=0.30, P=0.004, (exercise)). C-reactive protein (CRP) and Interleukin (IL)-6 levels were not associated with E-DII changes at 12-months. In conclusion, a behavior change of low-calorie, low-fat diet significantly reduces dietary inflammatory potential, modulating biomarkers that are associated with tumorigenesis, such as VEGF, but not CRP or IL-6.",2020,C-reactive protein (CRP) and Interleukin (IL)-6 levels were not associated with E-DII changes at 12-months.,"['Women', '365 participants with complete FFQs at baseline and 12-months', '438 overweight/obese, healthy, postmenopausal women']","['diet and diet+exercise', 'caloric-restriction diet (goal: 10% weight-loss), aerobic-exercise (225 min/week moderate-to-vigorous activity), combined diet+exercise, or control']","['C-reactive protein (CRP) and Interleukin (IL)-6 levels', 'E-DII ', 'vascular endothelial growth factor', 'E-DII scores', 'Dietary inflammatory index (DII®) and energy-adjusted (E-DIITM) scores', 'red blood cell counts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",438.0,0.0711963,C-reactive protein (CRP) and Interleukin (IL)-6 levels were not associated with E-DII changes at 12-months.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Duggan', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center cduggan@fredhutch.org.'}, {'ForeName': 'Jean de Dieu', 'Initials': 'JD', 'LastName': 'Tapsoba', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Epidemiology and Biostatistics, University of South Carolina.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Harris', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Epidemiology and Biostatistics, University of South Carolina.'}, {'ForeName': 'Ching-Yun', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'McTiernan', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0181']
2963,32859661,Feasibility and acceptability of a dietary intervention study to reduce salt intake and increase high-nitrate vegetable consumption among middle-aged and older Malaysian adults with elevated blood pressure: a study protocol.,"INTRODUCTION


Global population ageing is one of the key factors linked to the projected rise of dementia incidence. Hence, there is a clear need to identify strategies to overcome this expected health burden and have a meaningful impact on populations' health worldwide. Current evidence supports the role of modifiable dietary and lifestyle risk factors in reducing the risk of dementia. In South-East Asia, changes in eating and lifestyle patterns under the influence of westernised habits have resulted in significant increases in the prevalence of metabolic, cardiovascular and neurodegenerative non-communicable diseases (NCDs). Low vegetable consumption and high sodium intake have been identified as key contributors to the increased prevalence of NCDs in these countries. Therefore, nutritional and lifestyle strategies targeting these dietary risk factors are warranted. The overall objective of this randomised feasibility trial is to demonstrate the acceptability of a dietary intervention to increase the consumption of high-nitrate green leafy vegetables and reduce salt intake over 6 months among Malaysian adults with raised blood pressure.
METHODS AND ANALYSIS


Primary outcomes focus on feasibility measures of recruitment, retention, implementation and acceptability of the intervention. Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed). Adherence to the dietary intervention will be assessed through collection of biological samples, 24-hour recall and Food Frequency Questionnaire. A subgroup of participants will also complete postintervention focus groups to further explore the feasibility considerations of executing a larger trial, the ability of these individuals to make dietary changes and the barriers and facilitators associated with implementing these changes.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from Monash University Human Research Ethics Committee and Medical Research and Ethics Committee of Malaysia. Results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.ISRCTN47562685; Pre-results.",2020,"Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed).","['Malaysian adults with raised blood pressure', 'middle-aged and older Malaysian adults with elevated blood pressure']",['dietary intervention'],"['prevalence of metabolic, cardiovascular and neurodegenerative non-communicable diseases (NCDs', 'blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed', 'feasibility measures of recruitment, retention, implementation and acceptability of the intervention']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0453725,"Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McGrattan', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK Andrea.McGrattan@Newcastle.ac.uk.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Mohan', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Pei Wei', 'Initials': 'PW', 'LastName': 'Chua', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Azizah', 'Initials': 'A', 'LastName': 'Mat Hussin', 'Affiliation': 'Kampus Cawangan Institute of Medical Science Technology, Universiti Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Yee Chang', 'Initials': 'YC', 'LastName': 'Soh', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Mawada', 'Initials': 'M', 'LastName': 'Alawad', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Bin Kassim', 'Affiliation': 'District Health Office, Pejabat Kesihatan Daerah (PKD) Segamat, Segamat, Johor, Malaysia.'}, {'ForeName': 'Ahmad Nizal', 'Initials': 'AN', 'LastName': 'Bin Mohd Ghazali', 'Affiliation': 'District Health Office, Pejabat Kesihatan Daerah (PKD) Segamat, Segamat, Johor, Malaysia.'}, {'ForeName': 'Blossom', 'Initials': 'B', 'LastName': 'Stephan', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Allotey', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Reidpath', 'Affiliation': 'South East Asia Community Observatory (SEACO), Monash University Malaysia, Segamat, Johor, Malaysia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Robinson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': 'School of Life Sciences, University of Nottingham, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035453']
2964,32859662,"Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG).","OBJECTIVES


The choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.
DESIGN


YonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.
PARTICIPANTS


Six hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.
RESULTS


After 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: -2.4, 95% CI: -9.2 to 4.5) as compared with CA (ΔFACT-G total score: -3.9; 95% CI:-11.3 to 3.5; p = 0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p = 0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.
CONCLUSION


Our data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier (NCT02204111).",2020,"Overall mean survival was longer in IA (648 days) than in CA (389 days, p = 0.110).","['Six hospitals', 'Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set', 'patients with soft tissue sarcoma undergoing treatment with', 'patients with advanced STS undergoing treatment with', 'advanced soft tissue sarcoma (STS']","['tailored multistep intervention', 'trabectedin', 'tailored palliative care intervention']","['change of Functional Assessment for Cancer Therapy (FACT-G) total score', 'QoL, symptoms and survival', 'efficacy, quality of life (QoL) and toxicity', 'Overall mean survival', 'QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment', 'symptom severity, symptom interference, depression and anxiety', 'Quality of life and added value', 'MDASI, FAACT, HADS and BPI scales']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",79.0,0.215055,"Overall mean survival was longer in IA (648 days) than in CA (389 days, p = 0.110).","[{'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Hentschel', 'Affiliation': 'Department of Psychooncology of the University Cancer Center (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany Leopold.Hentschel@uniklinikum-dresden.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Interdisciplinary Center for Soft-Tissue-Sarcoma, GIST and Bone-Tumor, Robert-Bosch-Center of Tumor Diseases, Stuttgart, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kasper', 'Affiliation': 'Sarcoma Unit, Interdisciplinary Tumor Center, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Kunitz', 'Affiliation': 'Internal Medicine, Vivantes Clinic Spandau, Berlin, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology/West-German Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Hematology Oncology, University Hospital of Münster, Münster, Germany.'}, {'ForeName': 'Jens Marcus', 'Initials': 'JM', 'LastName': 'Chemnitz', 'Affiliation': 'Internal Medicine, ev. Stift St. Martin, Koblenz, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology, Charité Medical University, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schuler', 'Affiliation': 'University Palliative Center, University Hospital Carl Gustav Carus, Dresden, Sachsen, Germany.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Freitag', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schilling', 'Affiliation': 'Department of Social Work, University Hospital Carl Gustav Carus, Dresden, Sachsen, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Hornemann', 'Affiliation': 'Department of Psychooncology of the University Cancer Center (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Arndt', 'Affiliation': 'Patient Advocacy, Das Lebenshaus e.V, Wölfersheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bornhäuser', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Markus Kajo', 'Initials': 'MK', 'LastName': 'Schuler', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-035546']
2965,32859666,"Protocol for the process evaluation of the Promoting Activity, Independence and Stability in Early Dementia (PrAISED), following changes required by the COVID-19 pandemic.","INTRODUCTION


The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) randomised controlled trial (RCT) is evaluating a home-based, face-to-face, individually tailored, activity and exercise programme for people living with dementia. Social distancing requirements following the COVID-19 pandemic necessitated rapid changes to intervention delivery.
METHODS AND ANALYSIS


A mixed-methods process evaluation will investigate how the changes were implemented and the impact that these have on participants' experience. An  implementation study  will investigate how the intervention was delivered during the pandemic. A  study on the mechanisms of impact and context  will investigate how these changes were experienced by the PrAISED participants, their carers and the therapists delivering the intervention. The study will commence in May 2020.
ETHICS AND DISSEMINATION


The PrAISED RCT and process evaluation have received ethical approval number 18/YH/0059. The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support. This will be valuable both in explaining trial results and also contribute to understanding and designing new ways of delivering home-based services and rehabilitation interventions for people with dementia and their carers.
TRIAL REGISTRATION NUMBER


ISRCTN15320670; Pre-results.",2020,"The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support.","['people living with dementia', 'people with dementia and their carers']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",[],[],,0.0812684,"The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Di Lorito', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK claudio.dilorito@nottingham.ac.uk.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bosco', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Goldberg', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'van der Wardt', 'Affiliation': 'Philipps-Universitat Marburg, Marburg, Hessen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Pollock', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Booth', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Pip', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Dunlop', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Horne', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rowan H', 'Initials': 'RH', 'LastName': 'Harwood', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039305']
2966,32859702,High Interobserver Agreement for the Standardized Reporting System SSTR-RADS 1.0 on Somatostatin Receptor PET/CT.,"Objectives:  Recently, a standardized framework system for interpreting somatostatin receptor (SSTR)-targeted PET/CTs, termed SSTR-Reporting and Data System (RADS) 1.0, has been introduced providing reliable standards and criteria for SSTR-targeted imaging. We determined the interobserver reliability of SSTR-RADS for interpretation of  68 Ga-DOTATOC PET/CT scans in a multicentric, randomized setting.  Methods:  A set of 51 randomized  68 Ga-DOTATOC PET/CT scans was independently assessed by four blinded readers with different levels of experience (2 experienced readers (ER) and 2 inexperienced readers (IR)) trained with SSTR-RADS 1.0 criteria (based on a 5-point scale (from 1 = definitively benign to 5 = high certainty that neuroendocrine neoplasia is present)). Per scan, SSTR-RADS scores were assigned to a maximum of 5 target lesions (TL). An overall scan impression based on SSTR-RADS was indicated, and interobserver agreement rates on a TL-based, on an organ-based, and on an overall SSTR-RADS score-based level were computed. Readers were also asked to decide whether peptide receptor radionuclide therapy (PRRT) should be considered based on the assigned RADS scores.  Results:  Among the selected TL, 153 were chosen by at least 2 individual observers (all 4 readers selected the same TL in 58 of 153 [37.9%] instances). The interobserver agreement for SSTR-RADS scoring among identical TL was good (intraclass correlation coefficient [ICC] for 4, 3, and 2 identical TL, ≥0.73, respectively). For lymph node and liver lesions, excellent interobserver agreement rates were derived (ICC, 0.91 and 0.77, respectively). Moreover, the interobserver agreement for an overall scan impression based on SSTR-RADS was excellent (ICC, 0.88). Decision for PRRT based on SSTR-RADS also demonstrated an excellent agreement with an ICC of 0.80. No significant differences between ER and IR for an overall scan and TL-based SSTR-RADS scoring were observed (p≥0.18, respectively), thereby suggesting that SSTR-RADS seems to be readily applicable even for less experienced readers.  Conclusion:  SSTR-RADS-guided assessment demonstrated a high concordance rate, even among readers with different experience, supporting the adoption of SSTR-RADS for trials, clinical routine or outcome studies.",2020,"No significant differences between ER and IR for an overall scan and TL-based SSTR-RADS scoring were observed (p≥0.18, respectively), thereby suggesting that SSTR-RADS seems to be readily applicable even for less experienced readers.  ",[],"['SSTR-RADS-guided assessment', 'peptide receptor radionuclide therapy (PRRT']",['ER and IR for an overall scan and TL-based SSTR-RADS scoring'],[],"[{'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0206473', 'cui_str': 'Peptide Receptor'}, {'cui': 'C0203608', 'cui_str': 'Radionuclide therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}]",153.0,0.0505497,"No significant differences between ER and IR for an overall scan and TL-based SSTR-RADS scoring were observed (p≥0.18, respectively), thereby suggesting that SSTR-RADS seems to be readily applicable even for less experienced readers.  ","[{'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'Werner', 'Affiliation': 'Hannover Medical School, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Derlin', 'Affiliation': 'Hannover Medical School, Department of Nuclear Medicine.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'Johns Hopkins School of Medicine, The Russell H Morgan Department of Radiology and Radiological Science, Division of Nuclear Medicine.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Bundschuh', 'Affiliation': 'Department of Nuclear Medicine, University Medical Hospital Bonn, Medical Faculty.'}, {'ForeName': 'Gabriel T', 'Initials': 'GT', 'LastName': 'Sheikh', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Augsburg.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Pomper', 'Affiliation': 'Johns Hopkins School of Medicine, The Russell H Morgan Department of Radiology and Radiological Science, Division of Nuclear Medicine.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Hannover Medical School, Department of Nuclear Medicine.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'University Hospital Wuerzburg, Department of Nuclear Medicine.'}, {'ForeName': 'Andreas K', 'Initials': 'AK', 'LastName': 'Buck', 'Affiliation': 'University Hospital Wuerzburg, Department of Nuclear Medicine.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Bengel', 'Affiliation': 'Hannover Medical School, Department of Nuclear Medicine.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'Bundschuh', 'Affiliation': 'Department of Nuclear Medicine, University Medical Hospital Bonn, Medical Faculty,.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Lapa', 'Affiliation': 'University Hospital Augsburg, Department of Nuclear Medicine.'}]","Journal of nuclear medicine : official publication, Society of Nuclear Medicine",['10.2967/jnumed.120.245464']
2967,31911147,"Safety, pharmacokinetics, and antiretroviral activity of islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor, following single-dose administration to treatment-naive adults infected with HIV-1: an open-label, phase 1b, consecutive-panel trial.","BACKGROUND


Islatravir (also known as ISL and MK-8591) is a unique nucleoside reverse transcriptase translocation inhibitor in clinical development for treatment of people with HIV-1 infection. In preclinical studies, intracellular islatravir-triphosphate exhibits a long half-life and prolonged virological effects. In this study, we aimed to assess islatravir safety, pharmacokinetics, and antiretroviral activity in treatment-naive adults with HIV-1 infection.
METHODS


This open-label, consecutive-panel, phase 1b trial was done at Charité Research Organisation (Berlin, Germany) and included men and women (aged 18-60 years, inclusive) with HIV-1 infection who were ART naive. Participants were required to have plasma HIV-1 RNA counts of at least 10 000 copies per mL within 30 days before the trial treatment phase, without evidence of resistance to nucleoside reverse transcriptase inhibitors. Participants were enrolled in one of five consecutive dosing panels, receiving a single oral dose of islatravir (0·5-30 mg). The primary outcomes were safety and tolerability of islatravir and change from baseline in HIV-1 plasma RNA; secondary outcomes were islatravir plasma and islatravir-triphosphate intracellular pharmacokinetics. We obtained descriptive safety and pharmacokinetics statistics, and estimated efficacy results from a longitudinal data analysis model. This study is registered with ClinicalTrials.gov, NCT02217904, and EudraCT, 2014-002192-28.
FINDINGS


Between Sept 17, 2015, and May 11, 2017, we enrolled 30 participants (six per panel). Islatravir was generally well tolerated. 27 (90%) participants had 60 adverse events after receipt of drug, of which 21 (35%) were deemed to be drug related. The most common (n>1) drug-related adverse events were headache (in nine [30%] participants) and diarrhoea (in two [7%]). No serious adverse events were reported, and no participants discontinued due to an adverse event. Plasma islatravir pharmacokinetics and intracellular islatravir-triphosphate pharmacokinetics were approximately dose proportional. The islatravir-triphosphate intracellular half-life was 78·5-128·0 h. Least-squares mean HIV-1 RNA at 7 days after dose decreased from 1·67 log 10  copies per mL (95% CI 1·42-1·92) at 10 mg dose to 1·20 log 10  copies per mL (0·95-1·46) at 0·5 mg dose. No genetic changes consistent with development of viral resistance were detected.
INTERPRETATION


Single doses of islatravir as low as 0·5 mg significantly suppressed HIV-1 RNA by more than 1·0 log at day 7 in treatment-naive adults with HIV-1 infection and were generally well tolerated, supporting the further development of islatravir as a flexible-dose treatment for individuals with HIV-1 infection.
FUNDING


Merck Sharp & Dohme Corp, a subsidiary of Merck & Co Inc, Kenilworth, NJ, USA.",2020,"mg significantly suppressed HIV-1 RNA by more than 1·0 log at day 7 in treatment-naive adults with HIV-1 infection and were generally well tolerated, supporting the further development of islatravir as a flexible-dose treatment for individuals with HIV-1 infection.
","['men and women (aged 18-60 years, inclusive) with HIV-1 infection who were ART naive', '2014-002192-28', 'treatment-naive adults with HIV-1 infection', 'people with HIV-1 infection', 'Between Sept 17, 2015, and May 11, 2017', 'individuals with HIV-1 infection', 'naive adults infected with HIV-1', 'enrolled 30 participants (six per panel']","['nucleoside reverse transcriptase inhibitors', 'islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor']","['headache', 'Safety, pharmacokinetics, and antiretroviral activity', 'diarrhoea', 'plasma HIV-1 RNA counts', 'islatravir safety, pharmacokinetics, and antiretroviral activity', 'HIV-1 RNA', 'viral resistance', 'safety and tolerability of islatravir and change from baseline in HIV-1 plasma RNA; secondary outcomes were islatravir plasma and islatravir-triphosphate intracellular pharmacokinetics', 'tolerated', 'Plasma islatravir pharmacokinetics and intracellular islatravir-triphosphate pharmacokinetics', 'serious adverse events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C4549592', 'cui_str': 'MK-8591'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0520989', 'cui_str': 'Viral resistance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0077289', 'cui_str': 'tris(chloroethyl)phosphate'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.184995,"mg significantly suppressed HIV-1 RNA by more than 1·0 log at day 7 in treatment-naive adults with HIV-1 infection and were generally well tolerated, supporting the further development of islatravir as a flexible-dose treatment for individuals with HIV-1 infection.
","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schürmann', 'Affiliation': 'Charité Research Organisation, Berlin, Germany; Department of Infectious Diseases and Pulmonary Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Deanne Jackson', 'Initials': 'DJ', 'LastName': 'Rudd', 'Affiliation': 'Merck & Co Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Saijuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'De Lepeleire', 'Affiliation': 'Merck Sharp & Dohme (Europe) Inc, Brussels, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Robberechts', 'Affiliation': 'Merck Sharp & Dohme (Europe) Inc, Brussels, Belgium.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Friedman', 'Affiliation': 'Merck & Co Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Keicher', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüser', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hofmann', 'Affiliation': 'Institute of Virology, Charité Universitätsmedizin Berlin, Berlin, Germany; Labor Berlin - Charité Vivantes, Berlin, Germany.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Grobler', 'Affiliation': 'Merck & Co Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Randolph P', 'Initials': 'RP', 'LastName': 'Matthews', 'Affiliation': 'Merck & Co Inc, Kenilworth, NJ, USA. Electronic address: randolph.matthews@merck.com.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30372-8']
2968,32860696,Does High Frequency Chest Wall Oscillation Have an Impact on Improving Pulmonary Function in Patients with Smoke Inhalation Injury?,"[PURPOSE]


Smoke inhalation results in bronchospasm of the trachea, increasing secretion of mucus, casts formation, and improvement of blood flow of the airway. High frequency chest wall oscillation is a common modality used for clearing mucous secretion in patients suffering from hypersecretion of thick mucus and used also to help cough clearance. This study aimed to detect the effect of high frequency chest wall oscillation in improving pulmonary function in burn patients suffering from smoke inhalation.
[PARTICIPANTS AND METHODS]


60 smoke inhalation injury patients were randomly distributed into 2 groups of equal size. Group A: received high frequency chest wall oscillation and conventional chest physical therapy (breathing exercises, early ambulation and cough training) thrice per week for 8 weeks. Group B: received traditional chest physical therapy (breathing exercises, early ambulation and cough training) thrice per week for 8 weeks. Pulmonary function test (forced vital capacity, forced expiratory volume in the first second and peak expiratory flow rate) was measured at enrollment and after 8 weeks by using spirometer.
[RESULTS]


Pulmonary function increased significantly post-treatment when compared with that pre-treatment in group A and B (p > 0.001). Also, they increased significantly in group A compared with that of group B post-treatment (p > 0.05).
[CONCLUSION]


High frequency chest wall oscillation have an impact on improving pulmonary function and should be handled to be a part of the pulmonary rehabilitation plan for smoke inhalation injury patients.",2020,Pulmonary function increased significantly post-treatment when compared with that pre-treatment in group A and B (p > 0.001).,"['patients suffering from hypersecretion of thick mucus', 'Patients with Smoke Inhalation Injury', '\n\n\n60 smoke inhalation injury patients', 'burn patients suffering from smoke inhalation', 'smoke inhalation injury patients']","['traditional chest physical therapy (breathing exercises, early ambulation and cough training', 'high frequency chest wall oscillation', 'high frequency chest wall oscillation and conventional chest physical therapy (breathing exercises, early ambulation and cough training']","['Pulmonary function test (forced vital capacity, forced expiratory volume in the first second and peak expiratory flow rate', 'bronchospasm of the trachea, increasing secretion of mucus, casts formation, and improvement of blood flow of the airway', 'pulmonary function', 'Pulmonary function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0037367', 'cui_str': 'Smoke inhalation injury'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0013457', 'cui_str': 'Ambulation, Early'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0040578', 'cui_str': 'Tracheal structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",60.0,0.0130483,Pulmonary function increased significantly post-treatment when compared with that pre-treatment in group A and B (p > 0.001).,"[{'ForeName': 'Nesma M', 'Initials': 'NM', 'LastName': 'Allam', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Manar M', 'Initials': 'MM', 'LastName': 'Badawy', 'Affiliation': 'Department of Physical Therapy for Cardiovascular, Pulmonary Disorders and Geriatrics. Faculty of Physical Therapy, Misr University for Science and Technology, Egypt.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa147']
2969,32860716,The effects of canola oil compared with sesame and sesame-canola oil on glycemic control and liver function enzymes in patients with type 2 diabetes: A 3-way randomized triple-blind cross-over clinical trial.,"BACKGROUND


This study aimed to compare the effects of sesame (SO), canola (CO), and sesame-canola (SCO: a blend) oils on glycemic control markers and liver function enzymes in adults with type 2 diabetes mellitus (T2DM).
METHODS


In this randomized, triple-blind, three-way, cross-over clinical trial, participants replaced their usual oil with the intervention oils for 9 weeks. Serum fasting blood sugar (FBS), fasting serum insulin (FSI), insulin resistance (HOMA2-IR), beta-cell function (HOMA2-%B), insulin sensitivity (HOMA2-%S), quantitative insulin sensitivity check index (QUICKI), as well as serum liver function enzymes were measured at baseline and end of intervention periods.
RESULTS


Ninety-two participants completed all treatment periods. After adjusting for confounders, all treatment oils resulted in significant improvements in FSI and HOMA2-%S (P<0.05). Sesame oil, and SCO led to favorable changes in HOMA2-IR and QUICKI (P<0.05). Following CO and SCO, there was a significant decrease in HOMA2-%B (P<0.05). The sex-stratified analysis revealed that FSI and HOMA2-IR were decreased after SO compared to CO in males (P=0.024). Serum gamma-glutamyl transferase (GGT) was significantly lower following SO compared to CO in females (P=0.02), however, the difference in change values was not significant (P=0.058).
CONCLUSIONS


Sesame oil consumption appears to improve glycemic control markers in males and serum GGT in females compared with CO in patients with type 2 diabetes (registration code: IRCT2016091312571N6). This article is protected by copyright. All rights reserved.",2020,"Serum gamma-glutamyl transferase (GGT) was significantly lower following SO compared to CO in females (P=0.02), however, the difference in change values was not significant (P=0.058).
","['patients with type 2 diabetes', 'adults with type 2 diabetes mellitus (T2DM']","['sesame (SO), canola (CO), and sesame-canola (SCO: a blend) oils', 'canola oil compared with sesame and sesame-canola oil']","['glycemic control and liver function enzymes', 'FSI and HOMA2-IR', 'Serum fasting blood sugar (FBS), fasting serum insulin (FSI), insulin resistance (HOMA2-IR), beta-cell function (HOMA2-%B), insulin sensitivity (HOMA2-%S), quantitative insulin sensitivity check index (QUICKI), as well as serum liver function enzymes', 'FSI and HOMA2-%S', 'glycemic control markers and liver function enzymes', 'HOMA2-%B', 'glycemic control markers', 'Serum gamma-glutamyl transferase (GGT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C1123051', 'cui_str': 'Sesame'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",92.0,0.0778848,"Serum gamma-glutamyl transferase (GGT) was significantly lower following SO compared to CO in females (P=0.02), however, the difference in change values was not significant (P=0.058).
","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Raeisi-Dehkordi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zimorovat', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moghtaderi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Zarei', 'Affiliation': 'Department of Clinical Biochemistry, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, MB, Canada.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3399']
2970,32860737,"Pharmacokinetics and pharmacodynamics of cenerimod, a selective S1P 1  R modulator, are not affected by ethnicity in healthy Asian and Caucasian subjects.","Cenerimod is a sphingosine-1-phosphate 1 receptor (S1P 1  R) modulator in Phase 2 development for treatment of systemic lupus erythematosus. Its pharmacokinetics (PK), pharmacodynamics (PD), as well as safety and tolerability were investigated in Caucasian and Asian subjects to allow for recruitment of Asian patients in future studies. A randomized, double-blind, placebo-controlled parallel-group study was performed in 20 healthy male subjects (n=10 per ethnicity). A single, oral dose of 4 mg cenerimod or placebo (ratio 8:2) was administered under fasted conditions. The PK of cenerimod were similar in Caucasian and Asian subjects indicated by geometric mean ratios (90 % confidence interval) of 0.99 (0.80-1.21) for maximum plasma concentration, 0.96 (0.75-1.24) for area under the plasma concentration-time curve from 0 to infinity, and 1.04 (0.86-1.25) for terminal half-life. Accordingly, the extent and time course of reduction in lymphocyte count (as PD biomarker) were also similar in Caucasian and Asian subjects as compared to placebo. As observed for other S1PR modulators, a transient mean (standard deviation) heart rate reduction in Caucasian (15.1 [14.8] bpm) and Asian (11.8 [6.16] bpm) subjects was observed following administration of cenerimod. The drug was safe and well tolerated indicated by occurrence of a single adverse event of chemical conjunctivitis in a Caucasian subject that was not suspected as study drug related. In conclusion, the determined absence of any relevant PK or PD differences supports using the same doses of cenerimod in Caucasian and Asian patients in upcoming late-phase studies.",2020,The drug was safe and well tolerated indicated by occurrence of a single adverse event of chemical conjunctivitis in a Caucasian subject that was not suspected as study drug related.,"['Caucasian and Asian subjects', 'healthy Asian and Caucasian subjects', '20 healthy male subjects (n=10 per ethnicity']","['sphingosine-1-phosphate 1 receptor (S1P 1  R) modulator', 'placebo', 'cenerimod or placebo']","['Its pharmacokinetics (PK), pharmacodynamics (PD', 'safety and tolerability', 'maximum plasma concentration', 'plasma concentration-time curve', 'geometric mean ratios', 'lymphocyte count']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}]",20.0,0.169499,The drug was safe and well tolerated indicated by occurrence of a single adverse event of chemical conjunctivitis in a Caucasian subject that was not suspected as study drug related.,"[{'ForeName': 'Pierre-Eric', 'Initials': 'PE', 'LastName': 'Juif', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, LLC, 1085 N. Harbor Blvd, Anaheim, CA, 92801, USA.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12873']
2971,32860783,"Development, application, and evaluation of a problem-based learning method in clinical laboratory education.","BACKGROUND


There is a big gap between theory and real clinical practice with respect to the structure of clinical laboratory medicine (CLM) education in China. An integrated teaching method is urgently required, to improve student competency and prepare students to deal with complex challenges in the working environment.
METHODS


A total of 122 fourth-year CLM students studying at Hubei University between 2018 and 2019 were randomly assigned to a traditional teaching methods group or a problem-based learning (PBL) group. In the PBL group students were instructed to exchange their thoughts, identify information gaps, rehearse and perform simulated clinical scenarios, and incorporate the new information into cases in small groups. Theory tests, questionnaires, and clinical performance assessments were used to evaluate the effectiveness of PBL and compare it with that of traditional teaching methods.
RESULTS


PBL resulted in significantly better theory test scores, better student feedback scores, and clinical performance assessments, and a higher rate of satisfaction among students and teachers.
CONCLUSION


PBL is an effective way to help CLM students develop comprehensive abilities to deal with real clinical laboratory work. It is a promising education method and should be generalized to all subtypes of clinical laboratory curriculums in the future.",2020,"RESULTS


PBL resulted in significantly better theory test scores, better student feedback scores, and clinical performance assessments, and a higher rate of satisfaction among students and teachers.
",['A total of 122 fourth-year CLM students studying at Hubei University between 2018 and 2019'],['traditional teaching methods group or a problem-based learning (PBL) group'],"['theory test scores, better student feedback scores, and clinical performance assessments']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0485131,"RESULTS


PBL resulted in significantly better theory test scores, better student feedback scores, and clinical performance assessments, and a higher rate of satisfaction among students and teachers.
","[{'ForeName': 'Xiandong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Guangwu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Clinical laboratory Science, Hubei University of Medicine, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical laboratory Science, Hubei University of Medicine, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Department of Laboratory Medicine, Taihe hospital, Hubei University of Medicine, Shiyan, 442000, Hubei, China; Department of Clinical laboratory Science, Hubei University of Medicine, Shiyan, 442000, Hubei, China; Hubei Key Laboratory of Embryonic Stem Cell research, Hubei University of Medicine, Shiyan, 442000, Hubei, China. Electronic address: chunyan_peng@taihehospital.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.08.037']
2972,32860791,Effects of Diet-Modulated Autologous Fecal Microbiota Transplantation on Weight Regain.,"BACKGROUND & AIMS


We evaluated the efficacy and safety of diet-modulated autologous fecal microbiota transplantation (aFMT) for treatment of weight regain after the weight loss phase.
METHODS


In the DIRECT-PLUS weight loss trial (May 2017 through July 2018), abdominally obese or dyslipidemic participants in Israel were randomly assigned to (1)healthy dietary guidelines, (2)Mediterranean diet, and (3)green-Mediterranean diet weight-loss groups. All groups received free gym membership and physical activity guidelines. Both iso-caloric Mediterranean groups consumed 28g/day walnuts (+440mg/d polyphenols provided). The green-Mediterranean dieters further consumed green tea (3-4 cups/day) and a Wolffia-globosa (Mankai strain;100g/day) green shake (+800mg/day polyphenols provided). After 6 months (weight-loss phase), 90 eligible participants (mean age, 52 years; mean weight loss, 8.3 kg) provided a fecal sample that was processed into aFMT by frozen, opaque and odorless capsules. The participants were then randomly assigned to groups that received 100 capsules containing their own fecal microbiota or placebo until month 14. The primary outcome was regain of the lost weight over the expected weight regain phase (months 6-14). Secondary outcomes were gastrointestinal symptoms, waist-circumference, glycemic status and changes in the gut microbiome, as measured by metagenomic sequencing and 16s-rRNA. We validated the results in a parallel in-vivo study of mice specifically fed with Mankai, as compared to control chow diet.
RESULTS


Of the 90 participants in the aFMT trial, 96% ingested at least 80 of 100 oral aFMT or placebo frozen capsules over the transplantation period. No aFMT-related adverse events or symptoms were observed. For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03). Accordingly, aFMT attenuated waist circumference gain (aFMT, 1.89cm vs placebo, 5.05cm;P=.01) and insulin rebound (aFMT, 1.46±3.6μIU/ml vs placebo, 1.64±4.7μIU/ml;P=.04) in the green Mediterranean group but not in the dietary guidelines or Mediterranean diet (P for the interaction=.04 and .03, respectively). The green-Mediterranean diet was the only intervention to induce a significant change in microbiome composition during the weight loss phase, and to prompt preservation of weight loss-associated specific bacteria and microbial metabolic pathways (mainly microbial sugar transport) following the aFMT. In mice, Mankai-modulated aFMT in the weight loss phase, compared with control diet aFMT, significantly prevented weight regain, and resulted in better glucose tolerance, during a high-fat-diet induced regain phase (P<.05 for all).
CONCLUSIONS


Autologous FMT, collected during the weight loss phase and administrated in the regain phase, might preserve weight loss and glycemic control and is associated with specific microbiome signatures. High-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure. (ClinicalTrials.gov number, NCT03020186).",2020,"For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03).","['90 eligible participants (mean age, 52 years; mean weight loss, 8.3 kg) provided a fecal sample that was processed into aFMT by frozen, opaque and odorless capsules', 'Of the 90 participants in the aFMT trial, 96% ingested at least 80 of 100 oral', 'abdominally obese or dyslipidemic participants in Israel']","['aFMT or placebo', 'diet-modulated autologous fecal microbiota transplantation (aFMT', '100 capsules containing their own fecal microbiota or placebo', 'aFMT', 'Diet-Modulated Autologous Fecal Microbiota Transplantation', '1)healthy dietary guidelines, (2)Mediterranean diet, and (3)green-Mediterranean diet weight-loss groups', 'Mankai-modulated aFMT', 'High-polyphenols, green plant-based or Mankai diet']","['Weight Regain', 'aFMT attenuated waist circumference gain', 'regain of the lost weight over the expected weight regain phase', 'better glucose tolerance', 'weight regain', 'gastrointestinal symptoms, waist-circumference, glycemic status and changes in the gut microbiome, as measured by metagenomic sequencing and 16s-rRNA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}]",90.0,0.0688763,"For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03).","[{'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Youngster', 'Affiliation': ""Pediatric Division and Center for Microbiome Research, Shamir Medical Center, Be'er Ya'akov, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: youngsteri@shamir.gov.il.""}, {'ForeName': 'Anat Yaskolka', 'Initials': 'AY', 'LastName': 'Meir', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'BioTechnology Institute, University of Minnesota; Saint Paul, MN 55108, USA; Department of Computer Science and Engineering, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Tuohy', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trento 38016. Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fava', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trento 38016. Italy.""}, {'ForeName': 'Matthias Uwe', 'Initials': 'MU', 'LastName': 'Scholz', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trento 38016. Italy.""}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ziv', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Reuven', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Tirosh', 'Affiliation': ""Division of Endocrinology, Diabetes and Metabolism, Sheba Medical Center, Tel-Hashomer, Israel; and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Rudich', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Clement', 'Affiliation': 'Sorbonne University/Inserm, NutriOmics research Unit, Nutrition department, Pitié-Salpêtrière hospital, Assistance-publique Hopitaux de Paris, 75013, Paris, France.'}, {'ForeName': 'Omry', 'Initials': 'O', 'LastName': 'Koren', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Dong D', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Harvard T.H. Chan School of Public Health.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': ""Harvard T.H. Chan School of Public Health; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Meir J', 'Initials': 'MJ', 'LastName': 'Stampfer', 'Affiliation': ""Harvard T.H. Chan School of Public Health; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Adjunct Faculty, Harvard T.H. Chan School of Public Health.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.041']
2973,32860843,Comparison of cardiac function between left bundle branch pacing and right ventricular outflow tract septal pacing in the short-term: A registered controlled clinical trial.,"BACKGROUND


The novel method of left bundle branch pacing (LBBP) has been reported to produce a narrower QRS duration and lower pacing threshold than right ventricular outflow tract septal pacing (RVOP). However, whether LBBP is superior to traditional RVOP in improving cardiac function still lacks sufficient evidence.
OBJECTIVE


The purpose of this study was to compare the changes in cardiac function (especially in brain natriuretic peptide (BNP)levels, left atrial function, and left ventricular diastolic function) within 7 days between LBBP and RVOP.
METHODS AND RESULTS


A single-centre prospective controlled registered clinical study was conducted with 84 patients with bradycardia indications. Forty-two patients underwent RVOP, and 42 patients underwent LBBP. The pacemaker parameters were adjusted so that the ventricular ratio was over 90% and rate was 60-70 bpm. The changes in BNP levels and echocardiogram and speckle-tracking echocardiagraphy findings were compared between the two groups before and within 7 days after implantation: (1) BNP: there was no significant difference in BNP level between the two groups before and 1 day after implantation, while the LBBP group had significantly lower levels than the RVOP group on day 7 [(65.15 ± 56.96)pg/ml vs.(129.82 ± 101.92)pg/ml, P < 0.001]. (2) Cardiac echocardiography: the e' value of the LBBP group was higher than that of the RVOP group 7 days after implantation[(6.39 ± 2.65) cm/s vs. (5.45 ± 1.35)cm/s, P = 0.049]. The E/e' and peak E-wave velocity in the LBBP group decreased significantly after 7 days [16.57 ± 6.55 vs. 12.75 ± 5.16 P = 0.043, (88.6 ± 24.37)cm/s vs. (75.68 ± 28.10)cm/s P = 0.030]; in contrast, there were no significant changes in the RVOP group [14.13 ± 3.85 vs.14.10 ± 4.85 P = 0.50, (77.33 ± 21.14)cm/s vs. (74.45 ± 23.03)cm/s P = 0.56). (3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
CONCLUSION


This study demonstrates that compared to RVOP, LBBP can increase left ventricular early diastolic function, improve BNP levels, and has a tendency to increase left atrial myocardial elasticity and left atrial strain capacity in the short term in pacemaker-dependent patients.",2020,"(3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
",['84 patients with bradycardia indications'],"['left bundle branch pacing (LBBP', 'RVOP', 'RVOP, LBBP', 'LBBP', 'left bundle branch pacing and right ventricular outflow tract septal pacing']","['peak E-wave velocity', 'ventricular ratio', 'BNP level', 'left atrial myocardial elasticity and left atrial strain capacity', 'brain natriuretic peptide (BNP)levels, left atrial function, and left ventricular diastolic function', 'BNP levels and echocardiogram and speckle-tracking echocardiagraphy findings', 'left atrial strain or the strain rate', 'absolute values of left atrial strain and strain rate', 'cardiac function', 'left ventricular early diastolic function, improve BNP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0459156', 'cui_str': 'Left bundle branch structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0225892', 'cui_str': 'Structure of outflow tract of right ventricle'}, {'cui': 'C0442004', 'cui_str': 'Septal'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",84.0,0.0197044,"(3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
","[{'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jing', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Bolun', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""Xiangya School of Medicine, Central South University, Changsha, People's Republic of China.""}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Miao', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Bofei', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Qiaoli', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Hongning', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Ruiqin', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China. Electronic address: 13230178060@163.com.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.08.048']
2974,32860912,"A reply to ""Surgery versus combined treatment with curettage and imiquimod for nodular basal cell carcinoma: One-year results of a noninferiority, randomized, controlled trial.""",,2020,,['nodular basal cell carcinoma'],['Surgery versus combined treatment with curettage and imiquimod'],[],"[{'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}]",[],,0.0793506,,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pitney', 'Affiliation': 'The Mater Hospital Brisbane. Electronic address: pitneythomas@gmail.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'The Mater Hospital Brisbane.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.08.093']
2975,32860991,"Osteoarthritis and Cartilage, brief report Automated MRI assessment confirms cartilage thickness modification in patients with knee osteoarthritis: post-hoc analysis from a phase II sprifermin study.","BACKGROUND


Sprifermin is under investigation as a potential disease-modifying osteoarthritis drug. Previously, 2-year results from the FORWARD study showed significant dose-dependent modification of cartilage thickness in the total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions, by quantitative magnetic resonance imaging (qMRI) using manual segmentation.
OBJECTIVE


To determine whether qMRI findings from FORWARD could be reproduced by an independent method of automated segmentation using an identical dataset and similar anatomical regions in a post-hoc analysis.
METHOD


Cartilage thickness was assessed at baseline and 6, 12, 18 and 24 months, using automated cartilage segmentation with active appearance models, a supervised machine learning method. Images were blinded for treatment and timepoint. Treatment effect was assessed by observed and adjusted changes using a linear mixed model for repeated measures.
RESULTS


Based on automated segmentation, statistically significant, dose-dependent structural modification of cartilage thickness was observed over 2 years with sprifermin vs placebo for TFTJ (overall treatment effect and dose response, both P<0.001), MFTC (P=0.004 and P=0.044), and LFTC (both P<0.001) regions. For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
CONCLUSIONS


Cartilage thickness assessed by automated segmentation provided a consistent dose response in structural modification compared with manual segmentation. This is the first time that two independent quantification methods of image analysis have reached the same conclusions in an interventional trial, strengthening the conclusions that sprifermin modifies structural progression in knee osteoarthritis.",2020,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
",['patients with knee osteoarthritis'],"['placebo', 'MRI assessment']","['structural modification of cartilage thickness', 'total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions', 'cartilage thickness', 'central lateral tibial (P<0.001) and central lateral femoral', 'MFTC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0581602', 'cui_str': 'Structural modification'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.166877,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brett', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: Alan.Brett@stryker.com.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: mike.bowes@stryker.com.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK. Electronic address: p.conaghan@leeds.ac.uk.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ladel', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: christoph.ladel@merckgroup.com.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Guehring', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: hans.guehring@merckgroup.com.'}, {'ForeName': 'Flavie', 'Initials': 'F', 'LastName': 'Moreau', 'Affiliation': 'EMD Serono, Billerica, MA, USA; a Business of Merck KGaA, Darmstadt, Germany. Electronic address: flavie.moreau@emdserono.com.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Department of Imaging and Functional Musculoskeletal Research; Institute of Anatomy & Cell Biology; Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.08.005']
2976,32861214,"Effect of water, sanitation, handwashing and nutrition interventions on enteropathogens in children 14 months old: a cluster-randomized controlled trial in rural Bangladesh.","BACKGROUND


We evaluated the impact of low-cost water, sanitation, handwashing (WSH) and child nutrition interventions on enteropathogen carriage in the WASH Benefits cluster-randomized controlled trial in rural Bangladesh.
METHODS


We analyzed 1411 routine fecal samples from children 14±2 months old in the WSH (n = 369), nutrition counseling plus lipid-based nutrient supplement (n = 353), nutrition plus WSH (n = 360), and control (n = 329) arms for 34 enteropathogens using quantitative PCR. Outcomes included the number of co-occurring pathogens; cumulative quantity of four stunting-associated pathogens; and prevalence and quantity of individual pathogens. Masked analysis was by intention-to-treat.
RESULTS


326 (99.1%) control children had one or more enteropathogens detected (mean 3.8±1.8). Children receiving WSH interventions had lower prevalence and quantity of individual viruses than controls (prevalence difference for norovirus: -11% [95% confidence interval [CI], -5 to -17%]; sapovirus: -9% [95%CI, -3 to -15%]; and adenovirus 40/41: -9% [95%CI, -2 to - 15%]). There was no difference in bacteria, parasites, or cumulative quantity of stunting-associated pathogens between controls and any intervention arm.
CONCLUSIONS


WSH interventions were associated with fewer enteric viruses in children aged 14 months. Different strategies are needed to reduce enteric bacteria and parasites at this critical young age.",2020,"There was no difference in bacteria, parasites, or cumulative quantity of stunting-associated pathogens between controls and any intervention arm.
","['children 14 months old', '1411 routine fecal samples from children 14±2 months old in the WSH (n = 369', 'rural Bangladesh']","['low-cost water, sanitation, handwashing (WSH) and child nutrition interventions', 'nutrition counseling plus lipid-based nutrient supplement (n = 353), nutrition plus WSH', 'water, sanitation, handwashing and nutrition interventions', 'WSH interventions']","['prevalence and quantity of individual viruses', 'bacteria, parasites, or cumulative quantity of stunting-associated pathogens', 'number of co-occurring pathogens; cumulative quantity of four stunting-associated pathogens; and prevalence and quantity of individual pathogens']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",1411.0,0.281525,"There was no difference in bacteria, parasites, or cumulative quantity of stunting-associated pathogens between controls and any intervention arm.
","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Grembi', 'Affiliation': 'Division of Infectious Diseases and Geographic Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Audrie', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, CA, United States of America.'}, {'ForeName': 'Md Abdul', 'Initials': 'MA', 'LastName': 'Karim', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Ohedul', 'Initials': 'MO', 'LastName': 'Islam', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Miah', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Elizabeth T Rogawski', 'Initials': 'ETR', 'LastName': 'McQuade', 'Affiliation': 'Division of Infectious Diseases & International Health, University of Virginia, Charlottesville, VA, United States of America.'}, {'ForeName': 'Shahjahan', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Ziaur', 'Initials': 'MZ', 'LastName': 'Rahman', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Zahir', 'Initials': 'Z', 'LastName': 'Hussain', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Abul K', 'Initials': 'AK', 'LastName': 'Shoab', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Syeda L', 'Initials': 'SL', 'LastName': 'Famida', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Saheen', 'Initials': 'MS', 'LastName': 'Hossen', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Palash', 'Initials': 'P', 'LastName': 'Mutsuddi', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Rashidul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Taniuchi', 'Affiliation': 'Division of Infectious Diseases & International Health, University of Virginia, Charlottesville, VA, United States of America.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Infectious Diseases & International Health, University of Virginia, Charlottesville, VA, United States of America.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases & International Health, University of Virginia, Charlottesville, VA, United States of America.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Holmes', 'Affiliation': 'Department of Statistics, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, United States of America.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Benjamin-Chung', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, CA, United States of America.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, CA, United States of America.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases & International Health, University of Virginia, Charlottesville, VA, United States of America.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Division of Infectious Diseases and Geographic Medicine, Stanford University, Stanford, CA, United States of America.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa549']
2977,32861217,"Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients with Major Depressive Disorder Who Have Active Suicide Ideation with Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II).","BACKGROUND


Patients with major depressive disorder (MDD) having active suicidal ideation with intent require immediate treatment.
METHODS


This double-blind study (ASPIRE II) randomized adults (aged 18-64 years) with MDD having active suicidal ideation with intent to esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, given with comprehensive standard-of-care (hospitalization ≥5 days and newly-initiated or optimized oral antidepressant[s]). Change from baseline to 24 hours post-first dose in Montgomery-Asberg Depression Rating Scale (MADRS) total score (primary efficacy endpoint) was analyzed using analysis of covariance (ANCOVA). Clinical Global Impression-Severity of Suicidality - revised (CGI-SS-r; key secondary endpoint) was analyzed using ANCOVA on ranks of change.
RESULTS


Of 230 patients who were randomized (115 per arm), 227 received study drug and were included in efficacy/safety analyses; 184 (80.0%) completed double-blind treatment. Greater improvement in MADRS total score was observed with esketamine (mean [SD]: -15.7 [11.56]) versus placebo (-12.4 [10.43]), each with standard-of-care, at 24 hours (least-squares, LS, mean difference [SE]: -3.9 [1.39], 95% CI: -6.60, -1.11; 2-sided p=0.006). This was also noted at the earlier (4-hour) timepoint (LS mean difference -4.2, 95% CI: 6.38, 1.94). Patients in both treatment groups experienced rapid reduction in CGI-SS-r; the between-group difference was not statistically significant. The most common adverse events among esketamine-treated patients were dizziness, dissociation, nausea, dysgeusia, somnolence, headache, and paresthesia.
CONCLUSION


This study confirmed rapid and robust reduction of depressive symptoms with esketamine nasal spray in severely ill patients with MDD who have active suicidal ideation with intent.
TRIAL REGISTRATION


Clinical Trials.gov identifier: NCT03097133.",2020,"Greater improvement in MADRS total score was observed with esketamine (mean [SD]: -15.7 [11.56]) versus placebo (-12.4 [10.43]), each with standard-of-care, at 24 hours (least-squares, LS, mean difference [SE]: -3.9 [1.39], 95% CI: -6.60, -1.11; 2-sided p=0.006).","['Who Have Active Suicide Ideation with Intent', 'severely ill patients with MDD who have active suicidal ideation with intent', '230 patients who were randomized ', 'Patients with Major Depressive Disorder', 'Patients with major depressive disorder (MDD) having active suicidal ideation with intent require immediate treatment', 'adults (aged 18-64 years) with MDD having active suicidal ideation with intent to']","['esketamine nasal spray', 'esketamine 84\xa0mg or placebo nasal spray twice-weekly for 4 weeks, given with comprehensive standard-of-care (hospitalization ≥5 days and newly-initiated or optimized oral antidepressant[s', 'placebo', 'Esketamine Nasal Spray']","['MADRS total score', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score', 'rapid reduction in CGI-SS-r', 'depressive symptoms', 'Depressive Symptoms', 'dizziness, dissociation, nausea, dysgeusia, somnolence, headache, and paresthesia']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0749133', 'cui_str': 'Active suicidal ideation'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",230.0,0.688972,"Greater improvement in MADRS total score was observed with esketamine (mean [SD]: -15.7 [11.56]) versus placebo (-12.4 [10.43]), each with standard-of-care, at 24 hours (least-squares, LS, mean difference [SE]: -3.9 [1.39], 95% CI: -6.60, -1.11; 2-sided p=0.006).","[{'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Dong-Jing', 'Initials': 'DJ', 'LastName': 'Fu', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'Department of Statistics, Janssen Research and Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Department of Statistics, Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Statistics, Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Center of Brain Research, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Husseini', 'Initials': 'H', 'LastName': 'Manji', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Canuso', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ, USA.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa068']
2978,31404749,Outcomes following decline in forced vital capacity in patients with idiopathic pulmonary fibrosis: Results from the INPULSIS and INPULSIS-ON trials of nintedanib.,"BACKGROUND


We explored the impact of FVC decline on subsequent FVC decline and mortality in the INPULSIS trials of nintedanib in patients with IPF and their open-label extension, INPULSIS-ON.
METHODS


Changes in FVC and mortality between weeks 24 and 52 of the INPULSIS trials were assessed in patients with an increase/no decline in FVC % predicted and with declines in FVC <10% and ≥10% predicted from baseline to week 24. Changes in FVC and mortality in the first year of INPULSIS-ON were assessed in patients treated with nintedanib in the preceding INPULSIS trial who did and did not have a decline in FVC ≥10% predicted at week 52.
RESULTS


The proportion of placebo-treated patients with decline in FVC ≥10% predicted between weeks 24 and 52 of INPULSIS was similar in patients with increase/no decline in FVC and with decline in FVC ≥10% predicted between baseline and week 24 (20.5% and 18.9%, respectively). Mortality between weeks 24 and 52 of INPULSIS was higher in patients with FVC decline ≥10% predicted than <10% predicted between baseline and week 24 (13.2% vs 3.8%). Among nintedanib-treated patients in INPULSIS who had decline in FVC ≥10% versus <10% predicted at week 52, 34.0% versus 21.4%, respectively, had decline in FVC ≥10% predicted in the first year of INPULSIS-ON. Mortality in the first year of INPULSIS-ON was 21.3% vs 5.7% in these groups, respectively.
CONCLUSIONS


Decline in FVC did not predict FVC decline but was associated with mortality in patients with IPF.",2019,Mortality between weeks 24 and 52 of INPULSIS was higher in patients with FVC decline ≥10% predicted than <10% predicted between baseline and week 24 (13.2% vs 3.8%).,"['patients with IPF', 'patients with IPF and their open-label extension, INPULSIS-ON', 'patients with idiopathic pulmonary fibrosis']",[],"['FVC and mortality', 'FVC', 'Mortality', 'forced vital capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}]",,0.0564377,Mortality between weeks 24 and 52 of INPULSIS was higher in patients with FVC decline ≥10% predicted than <10% predicted between baseline and week 24 (13.2% vs 3.8%).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: luca.richeldi@policlinicogemelli.it.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'APHP, Service de Pneumologie A, Hôpital Bichat, DHU FIRE, INSERM, Unité 1152, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolb', 'Affiliation': ""McMaster University and St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Moisés', 'Initials': 'M', 'LastName': 'Selman', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosio Villegas"", Mexico City, Mexico.'}, {'ForeName': 'Wibke', 'Initials': 'W', 'LastName': 'Stansen', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Quaresma', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, Lyon, France.'}]",Respiratory medicine,['10.1016/j.rmed.2019.08.002']
2979,27748791,Validation of the Use of a Point-of-Care Device in Monitoring the International Normalised Ratio in Postoperative Cardiac Patients.,,2016,,['Postoperative Cardiac Patients'],[],[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.0276083,,"[{'ForeName': 'Hide E', 'Initials': 'HE', 'LastName': 'Wee', 'Affiliation': 'Department of Cardiology, National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Kenny Yk', 'Initials': 'KY', 'LastName': 'Sin', 'Affiliation': ''}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Chiang', 'Affiliation': ''}, {'ForeName': 'Kenneth Wq', 'Initials': 'KW', 'LastName': 'Guo', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
2980,30636569,Does State Dissociation Mediate the Relation Between Alcohol Intoxication and Deliberate Self-Harm?,"Research supports the notion that alcohol intoxication is a risk factor for deliberate self-harm (DSH). However, the underlying mechanisms for this relationship are poorly understood. We aimed to determine whether alcohol-induced dissociation mediated alcohol's effects on DSH. We used data from a dose-response study of alcohol intoxication and DSH to test the proposed model. Participants were assigned to reach target blood alcohol concentrations (BAC) ranging from 0.00% through 0.10% and then completed a behavioral measure of DSH. Dissociation was assessed using the Alcohol Dissociative Experiences Scale. BAC predicted both dissociation and DSH, but dissociation did not predict DSH. Although research on clinical populations suggests dissociation is related to DSH, our findings suggest dissociation does not mediate the effects of alcohol on self-harm.",2020,Participants were assigned to reach target blood-alcohol concentrations (BAC) ranging from 0.00% through 0.10% and then completed a behavioral measure of DSH.,[],[],"['blood-alcohol concentrations (BAC', 'Alcohol Dissociative Experiences Scale']",[],[],"[{'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0222045'}]",,0.024072,Participants were assigned to reach target blood-alcohol concentrations (BAC) ranging from 0.00% through 0.10% and then completed a behavioral measure of DSH.,"[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Timmins', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Berman', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Nadorff', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Amadi', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Fanning', 'Affiliation': 'The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'McCloskey', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2018.1563577']
2981,30953438,Beware of the Randomized Controlled Trial With Impressive Results!,,2019,,[],[],[],[],[],[],,0.16518,,"[{'ForeName': 'Achilleas', 'Initials': 'A', 'LastName': 'Thoma', 'Affiliation': 'Clinical Professor, Division of Plastic Surgery, Department of Surgery; and Associate Member, Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Coroneos', 'Affiliation': 'Assistant Professor, Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; and is Evidence-Based Medicine Section Co-editor for Aesthetic Surgery Journal (ASJ).'}]",Aesthetic surgery journal,['10.1093/asj/sjz080']
2982,30894063,The effect of rumination on recall of emotional words: comparison of dysphoric individuals with and without a history of nonsuicidal self-injury.,"Prior research and theory has suggested that rumination plays a role in nonsuicidal self-injury (NSSI), and rumination increases recall of negative autobiographical information in dysphoric individuals. Across two studies, we investigated whether rumination (versus distraction) differentially influences the recall of emotional words among dysphoric persons with and without a history of NSSI. Participants encoded unpleasant, neutral, and pleasant words and then were randomly assigned to either focus on the meaning and consequences of their emotions (i.e. rumination) or unrelated thoughts (i.e. distraction) before they were asked to recall encoded words. Across the two studies, we did not find a significant effect of rumination on memory for emotional words among dysphoric people with (Studies 1 and 2) or without a history of NSSI (Study 1). We did find that people were more likely to remember neutral words as opposed to unpleasant or pleasant words across studies, regardless of rumination condition. Together, results from these two well-powered studies provide fairly compelling evidence that rumination after encoding has little to no effect on recall for emotional words in people elevated on symptoms of depression or with NSSI history. These findings can be used to refine theories of rumination and NSSI.",2019,"We did find that people were more likely to remember neutral words as opposed to unpleasant or pleasant words across studies, regardless of rumination condition.","['dysphoric persons with and without a history of NSSI', 'dysphoric individuals with and without a history of nonsuicidal self-injury', 'dysphoric individuals']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}]",[],[],,0.0458964,"We did find that people were more likely to remember neutral words as opposed to unpleasant or pleasant words across studies, regardless of rumination condition.","[{'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Bresin', 'Affiliation': 'Department of Psychology, University of Illinois Urbana-Champaign , Champaign , IL , USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Mccowan', 'Affiliation': 'Department of Psychology, University of Illinois Urbana-Champaign , Champaign , IL , USA.'}, {'ForeName': 'Edelyn', 'Initials': 'E', 'LastName': 'Verona', 'Affiliation': 'Department of Psychology, University of South Florida , Tampa , FL , USA.'}]",Cognition & emotion,['10.1080/02699931.2019.1595529']
2983,31984781,"To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial.","BACKGROUND/AIMS


The  Intent to Attend  is a brief questionnaire recommended by the National Research Council to address dropout concerns and improve prediction of missing data in clinical trials, although implementation has been very limited. As a formative study in pediatric research, the relationship between caregiver intentions and study compliance was investigated in a 180-day trial of dietary supplementation of preterm toddlers. Treatment effect estimation in the context of missing data was also explored.
METHODS


Study compliance (i.e. study completion, supplement adherence, and diary completion) was tracked over three study visits. Baseline questionnaires asked caregivers about intentions concerning study completion via the  Intent to Attend , screened for mental health symptoms (depression, trait anxiety), and captured family demographics. Simple and multiple logistic regression models were built to examine associations between caregiver intent and compliance outcomes. The  Intent to Attend  was also employed as an auxiliary variable to account for missing data within mixed models estimating the treatment effect on the primary outcomes.
RESULTS


Of the 316 caregiver-child dyads included, 95% of caregivers with low intentions had a child complete the study, but only 87% of caregivers with high intentions had a child complete the study. Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20). No effect measure modification by caregiver mental health, child sex, or annual income was detected. Income was the only significant predictor of study non-completion; the lowest income group was almost four times more likely to be study non-completers compared with the highest income group, even after adjustment for child sex and caregiver mental health (adjusted odds ratio = 3.59, 95% confidence interval: 1.38, 9.31). When using  Intent to Attend  as an auxiliary variable, similar results were obtained when compared with the original treatment effect estimates on the primary outcomes.
CONCLUSION


Contrary to prior adult studies, there is no clear relationship between caregiver intentions and study compliance. Findings elucidate the complexities of caregiver-child interactions during pediatric trial participation.",2020,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).",['preterm toddlers'],[],"['caregiver mental health, child sex, or annual income', 'child sex and caregiver mental health']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",316.0,0.224541,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).","[{'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Sullivan', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Wiese', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}]","Clinical trials (London, England)",['10.1177/1740774519893307']
2984,31610383,Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R).,"OBJECTIVES


To develop an age-based norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R).
METHODS


In sum, 33,835 submissions (data sample 1) of the expanded and revised BISQ-R by caregivers of infants and toddlers (1-36 months) were analyzed in the US via a publicly-available smartphone application, Johnson's® Bedtime®. Three subscales were created: Infant Sleep (IS; 5 items), Parent Perception (PP; 3 items), and Parent Behavior (PB; 11 items). The scoring algorithm was based on an age-based normative system, and each subscale was scored using a weighted average of items. Primary application of the scoring model was performed on a follow up set of 16,531 submissions (data sample 2). Secondary application was tested on an original web-based ecology study (data sample 3). Tertiary application was tested using previously published datasets consisting of a longitudinal study (data sample 4) and randomized control trial behavioral intervention study (data sample 5).
RESULTS


Overall application of the scoring algorithm was confirmed across multiple samples. Each subscale (IS, PP, PB) and total score (T) is age referenced (scores range from 0 to 100). Cross-comparison between subscales across studies reveal consistent and convergent relationships.
CONCLUSIONS


The BISQ-R provides a comprehensive assessment of infant and toddler sleep patterns, as well as parent perception and parent behaviors that may contribute to sleep outcomes. The age-based norm-referenced scoring system is publicly available to be used by researchers and clinicians.",2019,"The BISQ-R provides a comprehensive assessment of infant and toddler sleep patterns, as well as parent perception and parent behaviors that may contribute to sleep outcomes.",[],[],"['Brief Infant Sleep Questionnaire - Revised (BISQ-R', 'Each subscale (IS, PP, PB) and total score (T']",[],[],"[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0305894,"The BISQ-R provides a comprehensive assessment of infant and toddler sleep patterns, as well as parent perception and parent behaviors that may contribute to sleep outcomes.","[{'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Mindell', 'Affiliation': ""Psychology, Saint Joseph's University, Philadelphia, PA, USA; Sleep Center, Children's Hospital of Philadelphia, Philadelphia, PA, USA. Electronic address: jmindell@sju.edu.""}, {'ForeName': 'Russell A', 'Initials': 'RA', 'LastName': 'Gould', 'Affiliation': 'Johnson & Johnson Consumer Inc., Skillman, NJ, USA.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Tikotzy', 'Affiliation': 'Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Leichman', 'Affiliation': ""Psychology, Saint Joseph's University, Philadelphia, PA, USA.""}, {'ForeName': 'Russel M', 'Initials': 'RM', 'LastName': 'Walters', 'Affiliation': 'Johnson & Johnson Consumer Inc., Skillman, NJ, USA.'}]",Sleep medicine,['10.1016/j.sleep.2019.05.010']
2985,31583708,Smartphone-based exposure treatment for dental phobia: a pilot randomized clinical trial.,"OBJECTIVES


High levels of dental care-related fear/anxiety, as well as phobia, result in delay or avoidance of dental care, which are associated with poorer oral and overall health. Both pharmacotherapeutic and psychosocial methods are available to treat those with high levels of dental fear/anxiety or phobia, but they are infrequently used and not easily accessed. Smartphones are a potential vehicle for delivering exposure therapy (e.g., a treatment involving systematic encounter with fear-evoking stimuli), but there is a need to test the acceptability of this approach in regard to treatment of high levels of dental anxiety/fear and phobia.
METHODS


There were 36 patients with high dental anxiety/fear/phobia randomly assigned to either a treatment or a waitlist condition. Participants completed a pre- and two-week post-multimodal assessment, including a dental behavioral avoidance task. The treatment condition included 2 weeks of self-directed exposure delivered via a personal smartphone in the patients' natural environment.
RESULTS


Participants in the treatment condition utilized the smartphone exposure an average of 1.6 times daily (SD = 0.85), and found the self-directed exposure highly acceptable. Moreover, they had lower self-reported anxiety and decreased cardiac reactivity at the postassessment compared with the preassessment; no change in anxiety was found for the control condition from pre- to postassessment.
CONCLUSIONS


Highly anxious, fearful, and dental phobic participants utilized smartphone-delivered exposure therapy, and found it to be an acceptable treatment method. Results support the utility and promise for further testing of the personal smartphone in delivering self-directed exposure therapy for high dental fear/anxiety and phobia.",2020,There were 36 patients with high dental anxiety/fear/phobia randomly assigned to either a treatment or a waitlist condition.,"['dental phobia', '36 patients with high dental anxiety/fear/phobia']","['Smartphone-based exposure treatment', 'self-directed exposure delivered via a personal smartphone']","['anxiety', 'cardiac reactivity']","[{'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",36.0,0.0201543,There were 36 patients with high dental anxiety/fear/phobia randomly assigned to either a treatment or a waitlist condition.,"[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Arias', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'McNeil', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}]",Journal of public health dentistry,['10.1111/jphd.12340']
2986,30856270,"An Open-Label, 52-Week, Phase III Trial of Duloxetine in Japanese Patients with Chronic Low Back Pain.","OBJECTIVE


To evaluate the safety and efficacy of duloxetine treatment for 52 weeks.
DESIGN


Multicenter, open-label, phase III clinical study.
SETTING


Forty-one medical institutions in Japan.
SUBJECTS


Japanese patients with chronic low back pain (CLBP).
METHODS


Duloxetine 60 mg once-daily was administered for 52 weeks. Safety was evaluated based on adverse events (AEs), vital signs, laboratory test values, electrocardiogram, Columbia-Suicide Severity Rating Scale, and occurrence of falls. The efficacy outcome measures were the Brief Pain Inventory (BPI; average pain, worst pain, least pain, and pain right now), BPI Interference, Patient's Global Impression of Improvement (PGI-I), Clinical Global Impressions of Severity (CGI-S), Roland-Morris Disability Questionnaire-24 (RDQ-24), 36-Item Short-Form Health Survey (SF-36), and European Quality of Life-5 Dimensions Questionnaire (EQ-5D).
RESULTS


In total, 151 patients (83 who completed a 14-week placebo-controlled superiority trial and 68 newly registered patients) were enrolled. The incidence rates of AEs and adverse drug reactions (ADRs) were 86.1% and 50.3%, respectively. ADRs with an incidence of ≥5% were somnolence, constipation, nausea, and dry mouth. Treatment discontinuation for AEs occurred in 16 patients. A significant reduction in the BPI average pain score (mean ± SD) was observed at all assessment time points from week 2 (-1.02 ± 1.37) to week 50 (-2.26 ± 1.63), compared with baseline. BPI pain severity (worst pain, least pain, and pain right now), BPI Interference, PGI-I, CGI-S, RDQ-24, SF-36, and EQ-5D showed significant improvement.
CONCLUSION


Japanese patients with CLBP had significant pain reduction over 52 weeks without new safety concerns.",2019,"A significant reduction in the BPI average pain score (mean ± SD) was observed at all assessment time points from week 2 (-1.02 ± 1.37) to week 50 (-2.26 ± 1.63), compared with baseline.","['Japanese Patients with Chronic Low Back Pain', '151 patients (83 who completed a 14-week placebo-controlled superiority trial and 68 newly registered patients) were enrolled', 'Japanese patients with chronic low back pain (CLBP', 'Forty-one medical institutions in Japan', '16 patients', 'Japanese patients with']","['CLBP', 'Duloxetine', 'duloxetine']","['safety and efficacy', 'BPI pain severity (worst pain, least pain, and pain right now), BPI Interference, PGI-I, CGI-S, RDQ-24, SF-36, and EQ-5D', ""Brief Pain Inventory (BPI; average pain, worst pain, least pain, and pain right now), BPI Interference, Patient's Global Impression of Improvement (PGI-I), Clinical Global Impressions of Severity (CGI-S), Roland-Morris Disability Questionnaire-24 (RDQ-24), 36-Item Short-Form Health Survey (SF-36), and European Quality of Life-5 Dimensions Questionnaire (EQ-5D"", 'pain reduction', 'somnolence, constipation, nausea, and dry mouth', 'incidence rates of AEs and adverse drug reactions (ADRs', 'adverse events (AEs), vital signs, laboratory test values, electrocardiogram, Columbia-Suicide Severity Rating Scale, and occurrence of falls', 'BPI average pain score (mean ± SD']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4505129', 'cui_str': 'Superiority Trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",151.0,0.0925624,"A significant reduction in the BPI average pain score (mean ± SD) was observed at all assessment time points from week 2 (-1.02 ± 1.37) to week 50 (-2.26 ± 1.63), compared with baseline.","[{'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Konno', 'Affiliation': 'Department of Orthopaedic Surgery, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Alev', 'Affiliation': 'Eli Lilly Turkey, Istanbul, Turkey.'}, {'ForeName': 'Natsuko', 'Initials': 'N', 'LastName': 'Oda', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Enomoto', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz027']
2987,31729982,"Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial.","BACKGROUND


In a phase 3 randomized, double-blind, placebo-controlled trial, treatment with idelalisib, a phosphoinositol-3 kinase δ inhibitor, + bendamustine/rituximab improved progression-free survival (PFS) and overall survival (OS) in adult patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Here we report the results of health-related quality of life (HRQL) analyses from this study.
METHODS


From June 15, 2012 to August 21, 2014, 416 patients with R/R CLL were enrolled; 207 patients were randomized to the idelalisib arm and 209 to the placebo arm. In the 416 patients randomized to receive bendamustine/rituximab and either oral idelalisib 150 mg twice-daily or placebo, HRQL was assessed at baseline and throughout the blinded part of the study using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) and EuroQoL Five-Dimension (EQ-5D) visual analogue scale (VAS) questionnaires. The assessments were performed at scheduled patient visits; every 4 weeks for the first 6 months from the initiation of treatment, then every 8 weeks for the next 6 months, and every 12 weeks thereafter until end of study. Least-squares mean changes from baseline were estimated using a mixed-effects model by including treatment, time, and treatment-by-time interaction, and stratification factors as fixed effects. Time to first symptom improvement was assessed by Kaplan-Meier analysis.
RESULTS


In mixed-effects model analysis, idelalisib + bendamustine/rituximab treatment led to clinically meaningful improvements from baseline in leukemia-associated symptoms. Moreover, per Kaplan-Meier analysis, the proportion of patients with symptom improvement was higher and time to improvement was shorter among patients in the idelalisib-containing arm compared with those who did not receive idelalisib. The physical and social/family FACT-Leu subscale scores, along with the self-rated health assessed by EQ-VAS, showed improvement with idelalisib over placebo, but the difference did not reach statistical significance. The functional and emotional FACT-Leu subscale scores remained similar to placebo.
CONCLUSIONS


Addition of idelalisib to bendamustine/rituximab, apart from improving PFS and OS, had a neutral to beneficial impact on HRQL in patients with R/R CLL, particularly by reducing leukemia-specific disease symptoms.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01569295. Registered April 3, 2012.",2019,"The functional and emotional FACT-Leu subscale scores remained similar to placebo.
","['From June 15, 2012 to August 21, 2014, 416 patients with R/R CLL were enrolled; 207 patients', 'adult patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL', '416 patients randomized to receive']","['placebo', 'bendamustine/rituximab and either oral idelalisib 150\u2009mg twice-daily or placebo, HRQL', 'idelalisib + bendamustine/rituximab']","['physical and social/family FACT-Leu subscale scores', 'quality of life', 'progression-free survival (PFS) and overall survival (OS', 'FACT-Leu) and EuroQoL Five-Dimension (EQ-5D) visual analogue scale (VAS) questionnaires', 'functional and emotional FACT-Leu subscale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3848803', 'cui_str': 'idelalisib 150 MG [Zydelig]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",416.0,0.597663,"The functional and emotional FACT-Leu subscale scores remained similar to placebo.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': 'Department of Hematology, Niguarda Cancer Center, Niguarda Hospital, Piazza Ospedale Maggiore, 3, 20162, Milan, Italy. marco.montillo@ospedaleniguarda.it.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Pristupa', 'Affiliation': 'Department of Hematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wach', 'Affiliation': 'Department Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Miklós', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Department of Hematology, Somogy County Kaposi Mor Hospital, Kaposvar, Hungary.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Department of Hematology, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska Curie Institute of Oncology, Krakow, Poland.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'CHRU Lille, Unité GRITA, Department of Hematology, Université de Lille, Lille, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'University of Oxford, Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': 'Division of Hematology-Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Sanatan', 'Initials': 'S', 'LastName': 'Shreay', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Health and quality of life outcomes,['10.1186/s12955-019-1232-8']
2988,30374191,Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies.,"The endogenous opioid system is thought to play an important role in the regulation of mood. Buprenorphine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive treatment of major depressive disorder (MDD). To confirm results from early studies, we report the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and an inadequate response to antidepressant therapy (ADT) in FORWARD-4 and FORWARD-5: two phase 3, randomized, double-blind, placebo-controlled studies that utilized the same sequential parallel-comparison design. Efficacy was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). FORWARD-5 achieved the primary endpoint and demonstrated that adjunctive BUP/SAM 2 mg/2 mg was superior to placebo (average difference change from baseline to week 3 through end of treatment [EOT] in MADRS-6 and -10 versus placebo: -1.5, P = 0.018; -1.9, P = 0.026, respectively). FORWARD-4 did not achieve the primary endpoint (change from baseline in MADRS-10 at week 5 versus placebo: -1.8, P = 0.109), although separate analyses showed significant treatment differences at other timepoints using traditional, regulatory-accepted endpoints such as reduction in MADRS-10 at EOT. The pooled analysis of the two studies demonstrated consistently greater reduction in MADRS-10 scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple timepoints including EOT and average change from baseline to week 3 through EOT (-1.8, P = 0.010; -1.8, P = 0.004, respectively). The overall effect size (Hedges' g) in the pooled analyses for MADRS-10 change from baseline to EOT was 0.22. Overall, BUP/SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity. The most common AEs, occurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment group, which was more frequently than the placebo group, included nausea, constipation, dizziness, vomiting, somnolence, fatigue, and sedation. There was minimal evidence of abuse, and no evidence of dependence or opioid withdrawal by AEs or objective measures. This report describes adjunctive BUP/SAM 2 mg/2 mg combination, a therapy with a novel opioidergic mechanism of action, as a potential new treatment option for patients with MDD who have an inadequate response to currently available ADT.",2020,,['major depressive disorder'],['buprenorphine/samidorphan combination'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]",[],,0.231079,,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (CTNI), Harvard Medical School, Boston, MA, USA. MFAVA@mgh.harvard.edu.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine and the Corporal Michael Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Memisoglu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0284-1']
2989,32034908,Looming Vulnerability and Smoking Cessation Attempts.,"INTRODUCTION


The looming vulnerability model holds that people become anxious when they perceive threats as growing larger and accelerating toward them in space and time. Preliminary research suggested that a guided imagery induction designed to activate a sense that health consequences of smoking are a looming threat led more smokers to attempt to quit. This study tested the effect on quit attempts in a larger sample and examined age, sex, and sensation seeking as moderators.
AIMS AND METHODS


Adult smokers (≥10 cigarettes/day) screened for risk of anxiety or mood disorders (N = 278, 52% male; 77% African American) were randomly assigned to receive (1) looming vulnerability or (2) neutral guided imagery exercises. At a 4-week follow-up, they reported quit attempts, smoking rate, self-efficacy, outcome expectancies, and contemplation status.
RESULTS


Those in the looming condition (17%) were no more likely than those in the control condition (20%) to make a quit attempt. There were no significant group differences in expectancies, contemplation, or follow-up smoking rate, and no significant moderators.
CONCLUSIONS


The looming induction was the same one used in earlier work in which it had stronger effects. Those who respond to it with increased urgency about quitting smoking might be offset by others who are more reactant and deny the message. Inconsistencies across studies may reflect differences in inclusion criteria, such that the present sample was on average heavier smokers with longer smoking history and more severe nicotine dependence, yet higher self-efficacy.
IMPLICATIONS


An induction designed to activate a sense that the health consequences of smoking constitute a looming vulnerability failed to increase quit attempts or reduce smoking rate among adult daily smokers. Inconsistencies across studies might reflect varying sample characteristics resulting from changes in screening criteria.",2020,"There were no significant group differences in expectancies, contemplation, or follow-up smoking rate, and no significant moderators.
","['Adult smokers (>= 10 cigarettes/day) screened for risk of anxiety or mood disorders (N = 278, 52% male; 77% African American', 'adult daily smokers']",['looming vulnerability or (b) neutral guided imagery exercises'],"['smoking rate', 'quit attempts, smoking rate, self-efficacy, outcome expectancies, and contemplation status', 'expectancies, contemplation, or follow-up smoking rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.0153101,"There were no significant group differences in expectancies, contemplation, or follow-up smoking rate, and no significant moderators.
","[{'ForeName': 'David A F', 'Initials': 'DAF', 'LastName': 'Haaga', 'Affiliation': 'Department of Psychology, American University, Washington, DC.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Psychology, American University, Washington, DC.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Malloy', 'Affiliation': 'Department of Mathematics and Statistics, American University, Washington, DC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa034']
2990,32159808,Effect of Acupuncture vs Sham Procedure on Chemotherapy-Induced Peripheral Neuropathy Symptoms: A Randomized Clinical Trial.,,2020,,['Chemotherapy-Induced Peripheral Neuropathy Symptoms'],['Acupuncture'],[],"[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.396271,,"[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Iris W', 'Initials': 'IW', 'LastName': 'Zhi', 'Affiliation': 'Breast Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Qing S', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Piulson', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0681']
2991,31404466,Delivery of a Nicotine Replacement Therapy Sample at Outdoor Smoking Hotspots for Promoting Quit Attempts: A Pilot Randomized Controlled Trial.,"INTRODUCTION


Outdoor smoking hotspots are convenient venues for promoting smoking cessation. This randomized controlled trial aimed to obtain proof-of-concept evidence of the feasibility and preliminary effectiveness on quit attempts of delivering a 1-week free nicotine replacement therapy sample (NRTS) to smokers.
METHODS


This pilot parallel, single-blinded, two-group (1:1) randomized controlled trial proactively recruited adult smokers in outdoor smoking hotspots in Hong Kong. Smokers consuming at least 10 cigarettes per day and fit for NRT use were individually randomized to receive either a 1-week NRT gum/patch and brief advice lasting 10 minutes (NRTS, n = 50), or receive only brief advice (control, n = 50). The primary outcomes were any self-reported quit attempts (stop smoking for at least 24 hours) at 1- and 3-month telephone follow-up. Risk ratios from log-binomial regression models were used to assess the associations.
RESULTS


The NRTS increased quit attempts at 1-month (14% vs. 10%; adjusted risk ratio = 1.25, 95% CI = 0.43 to 3.61) and 3-month follow-up (26% vs. 12%; adjusted risk ratio = 2.17, 95% CI = 0.89 to 5.27), but the differences were not significant. Trial participation rate was about 81.3%. Around 54% of the intervention group participants used the NRT sample by the first month. The NRT users reported generally positive feedback about the usefulness of NRT sample for smoking cessation. Major factors of not using NRT included bad gum taste and their perception that NRT was not useful.
CONCLUSIONS


Delivering NRTS to smokers in outdoor smoking hotspots was feasible and efficacious in increasing NRT use. Additional post-recruitment support to sustain the use of NRT and cessation services is needed.
IMPLICATIONS


Our study supported that smokers at outdoor smoking hotspots can be approached for a brief smoking cessation intervention including an onsite delivery of NRTS. Delivering NRTS and a brief advice on using NRT to these smokers was feasible and efficacious to increase NRT use. A larger trial on the benefits on quit attempts and long-term abstinence is warranted.",2020,The NRTS increased quit attempts at 1-month (14% versus 10%; adjusted risk ratio (ARR) =,"['RCT proactively recruited adult smokers in outdoor smoking hotspots in Hong Kong', 'Smokers consuming ≥10 cigarettes per day and fit for NRT use', 'smokers', 'sample at outdoor smoking hotspots for promoting quit attempts']","['nicotine replacement therapy', 'NRT gum/patch and brief advice lasting 10 minutes (NRTS, n=50), or receive only brief advice (control', 'nicotine replacement therapy sample (NRTS', 'NRT']","['quit attempts', 'self-reported quit attempts (stop smoking', 'Risk ratios']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",,0.0640873,The NRTS increased quit attempts at 1-month (14% versus 10%; adjusted risk ratio (ARR) =,"[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'William Ho', 'Initials': 'WH', 'LastName': 'Cheung Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong, China.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz138']
2992,32217953,Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],"['Mifepristone Antagonization', 'Progesterone']",[],"[{'cui': 'C3146283', 'cui_str': 'Medical abortion'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.194373,,"[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Valley', 'Affiliation': 'St. Louis Park, Minnesota.'}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003781']
2993,32114905,A pragmatic approach to measuring adherence in treatment delivery in psychotherapy.,"Measuring therapists' adherence to treatment manuals is recommended for evaluating treatment integrity, yet ways to do this are poorly defined, time consuming, and costly. The aims of the study were to develop a Therapy Component Checklist (TCC) to measure adherence to manualised CBT; to test its application in research and clinical practice; to determine its validity; and consider its cost benefits. We conducted a randomised trial in 230 people with cancer evaluating effectiveness of CBT for depression. In this, therapists delivered manualised treatment.  Experts agreed on key components of therapy and therapists were asked to record these after therapy sessions by ticking a TCC. Inter-rater reliability was tested using an independent rater.  Therapists delivered 543 CBT sessions. TCCs were completed in 293, of which 39 were assessed by the independent rater. Self-reported TCC data suggested close adherence to the manual. Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items.  Self-rating of adherence saved around £96 per rating. In conclusion the TCC provides a quick and cost effective way of evaluating the components of therapy delivered. This approach could be applied to other psychological treatments and may help with linking therapeutic interventions with outcome.",2020,"Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items.  ",['230 people with cancer evaluating effectiveness of CBT for depression'],"['Therapy Component Checklist (TCC', 'TCC']","['TCCs', 'Self-rating of adherence saved']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]",230.0,0.0401702,"Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items.  ","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Serfaty', 'Affiliation': 'Division of Psychiatry, University College London , London, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London , London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Vickerstaff', 'Affiliation': 'Marie Curie Palliative Care Research Department, University College London , London, UK.'}, {'ForeName': 'Trefor', 'Initials': 'T', 'LastName': 'Aspden', 'Affiliation': 'Division of Psychiatry, University College London , London, UK.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1717594']
2994,31685797,"Chitosan oligosaccharide (GO2KA1) improves postprandial glycemic response in subjects with impaired glucose tolerance and impaired fasting glucose and in healthy subjects: a crossover, randomized controlled trial.","BACKGROUND


The antidiabetic and hypoglycemic effects of chitosan have been reported in previous studies. We have previously shown that chitosan oligosaccharide reduces postprandial blood glucose levels in vivo. We conducted a short-term crossover study to support the results of the previous study.
METHODS


The study was a randomized, double-blind, controlled crossover trial completed at one clinical research site. Subjects with impaired glucose tolerance and impaired fasting glucose and healthy subjects were randomly assigned to consume one of two different experimental test capsules that differed in only the sample source (GO2KA1 vs placebo), and all subjects were instructed to consume the 75 g sucrose within 15 min. After a 7-day interval, the subjects consumed the other capsules that were not consumed on the first day. We assessed blood glucose levels using a 2-h oral sucrose tolerance test. The study was registered at clinicaltrials.gov (NCT03650023).
RESULTS


The test group showed significantly lower blood glucose levels at 60 min (p = 0.010) and postprandial blood glucose areas under the curve (p = 0.012). The change in blood glucose levels at 60 min was significantly lower in the test group than in the placebo group (p = 0.017).
CONCLUSIONS


Based on the results of this study, the consumption of chitosan oligosaccharide (GO2KA1) supplements with a meal can effectively reduce postprandial blood glucose levels, which is relevant to the prevention of diabetes.",2019,The test group showed significantly lower blood glucose levels at 60 min (p = 0.010) and postprandial blood glucose areas under the curve (p = 0.012).,"['Subjects with impaired glucose tolerance and impaired fasting glucose and healthy subjects', 'subjects with impaired glucose tolerance and impaired fasting glucose and in healthy subjects']","['placebo', 'chitosan oligosaccharide', 'experimental test capsules that differed in only the sample source (GO2KA1 vs placebo', 'Chitosan oligosaccharide (GO2KA1']","['blood glucose levels', 'postprandial blood glucose areas', 'postprandial blood glucose levels', 'postprandial glycemic response']","[{'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3255751', 'cui_str': 'CHITOSAN OLIGOSACCHARIDE'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C4505759', 'cui_str': 'GO2KA1'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.127154,The test group showed significantly lower blood glucose levels at 60 min (p = 0.010) and postprandial blood glucose areas under the curve (p = 0.012).,"[{'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Min Cho', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Young-In', 'Initials': 'YI', 'LastName': 'Kwon', 'Affiliation': 'Department of Food and Nutrition, Hannam University, Daejeon, 305-811, Korea.'}, {'ForeName': 'Seong-Chul', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Institute of Functional Foods, KunpoongBio Co. Ltd., Jeju, 63010, Korea.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yeob Shin', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Division of Endocrinology and Metabolism, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Jong', 'Initials': 'J', 'LastName': 'Ho Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea. jhleeb@yonsei.ac.kr.'}]",Nutrition & diabetes,['10.1038/s41387-019-0099-4']
2995,32006156,The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial.,"BACKGROUND


The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI).
METHODS AND RESULTS


This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m 2 . Of those, 6973 (43.7%) patients with a BMI < 27 kg/m 2  had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m 2  (adjusted HR 1.24, 95% CI 1.02-1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (p interaction  = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m 2  (HR 0.69, 95% CI 0.51-0.94), but not in the ones with BMI ≥ 27 kg/m 2  (p interaction  = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies.
CONCLUSIONS


Overall, BMI did not influence the treatment effect seen with ticagrelor monotherapy; however, a beneficial effect of ticagrelor monotherapy was seen in ACS patients with BMI < 27 kg/m 2 .
TRIAL REGISTRATION


The trial has been registered with ClinicalTrials.gov, Number NCT01813435.",2020,"In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m 2  (HR 0.69, 95% CI 0.51-0.94), but not in the ones with BMI ≥ 27 kg/m 2  (p interaction  = 0.047).","['15,968 patients were stratified by baseline BMI with prespecified threshold of 27\xa0kg/m 2 ', 'patients undergoing percutaneous coronary intervention']","['ticagrelor monotherapy', 'ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT', 'percutaneous coronary intervention (PCI']","['rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction', 'higher risk of all-cause mortality', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",15968.0,0.218239,"In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m 2  (HR 0.69, 95% CI 0.51-0.94), but not in the ones with BMI ≥ 27 kg/m 2  (p interaction  = 0.047).","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Erasmus Medical Centre, Thoraxcentre, Rotterdam, the Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Belfast Health and Social Care Trust, Cardiology, Belfast, Ireland.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Pedro Canas', 'Initials': 'PC', 'LastName': 'da Silva', 'Affiliation': 'Serviço de Cardiologia, Hospital de Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cotton', 'Affiliation': 'Department of Cardiology, Heart and Lung Centre, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Koning', 'Affiliation': 'Cardiology Service, Saint Hilaire Clinic, Rouen, France.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Benno J W M', 'Initials': 'BJWM', 'LastName': 'Rensing', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen and Kerckhoff Heartand Thorax Center, University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université de Paris, Assistance Publique-Hôpitaux de Paris -Diderot, Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Cardiovascular Research Unit, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, NUIG (National University of Ireland, University Road, Galway)Galway, H91 TK33, Ireland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, NUIG (National University of Ireland, University Road, Galway)Galway, H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01604-1']
2996,32122717,Effects of spinal immobilization at 20° on end-tidal carbon dioxide.,"OBJECTIVE


The aim was to determine the effect on end-tidal carbon dioxide (ETCO 2 ) of spinal immobilization (SI) at a conventional 0° angle and to investigate the usefulness of immobilization at a 20° angle for preventing possible hypoventilation.
METHODS


The study included 80 healthy volunteers, randomly divided into two groups. Spinal backboards and cervical collars were applied in Group 1 using a 0° angle and in Group 2 using a 20° angle, with the head up. SI was continued for 1 h, and ETCO 2  values were measured at the 0th, 30th and 60th minute.
RESULTS


There were no significant differences between the groups in 0th and 30th minute ETCO 2 . However, after 60th minute, results showed a statistically significant increase in ETCO 2  in Group 1 (35.5 mmHg [IQR 25-75:35-38]) compared to Group 2 (34 mmHg [IQR 25-75:33-36]) (p < 0.001). During SI, there was a statistically significant increase in ETCO 2  in Group 1 (35 mmHg [IQR 25-75:34-36], 35.5 mmHg [IQR 25-75:34-37] and 36 mmHg [IQR 25-75:35-38] respectively at the 0th, 30th and 60th minute after SI) (p < 0.001) and no change in Group 2. Also, we found statistically significant differences between ΔETCO 2  levels in Groups 1 and 2 at all 3 time intervals.
CONCLUSION


Conventional SI with an angle of 0° led to an increase in ETCO 2  while subjects immobilization at a 20° angle maintained their initial ETCO 2  values. Immobilization at 20° may prevent decompensation in patients who have thoracic trauma or lung diseases or those who are elderly, pregnant, or obese.",2020,"Also, we found statistically significant differences between ΔETCO 2  levels in Groups 1 and 2 at all 3 time intervals.
","['patients who have thoracic trauma or lung diseases or those who are elderly, pregnant, or obese', '80 healthy volunteers']","['tidal carbon dioxide (ETCO 2 ) of spinal immobilization (SI', 'Conventional SI', 'spinal immobilization']",['ETCO'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]",[],80.0,0.0267368,"Also, we found statistically significant differences between ΔETCO 2  levels in Groups 1 and 2 at all 3 time intervals.
","[{'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Dağar', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey. Electronic address: sedadagar@gmail.com.'}, {'ForeName': 'Şeref Kerem', 'Initials': 'ŞK', 'LastName': 'Çorbacıoğlu', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Emektar', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Uzunosmanoğlu', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}, {'ForeName': 'Yunsur', 'Initials': 'Y', 'LastName': 'Çevik', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.02.042']
2997,31387766,A randomized controlled trial of public messaging to promote safe firearm storage among U.S. military veterans.,"BACKGROUND


The objectives of this study were to determine whether short-term exposure to firearm safety messaging significantly improved (1) firearm storage practices, and (2) attitudes of safe firearm storage behaviors among U.S. veterans, a group at elevated risk for firearm suicide.
DESIGN


A three-arm, parallel-group RCT was conducted online in the U.S. nationwide from December 2015 to January 2016.
SETTING


A national random sample of U.S. veterans (N = 358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults. All study activities were administered online over a three-week study period.
INTERVENTION


Participants were randomized and exposed three times (once per week) to either (a) firearm safety message only (n = 115); (b) firearm safety and mental health promotion messages (n = 133); or (c) active control group exposed to mental health promotion message only (n = 110). Each message was less than two minutes long.
MEASURES


Assessments were completed at baseline (pre-randomization) and at end-of-trial. Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys. Linear mixed effect models with weighted generalized estimating equations were used to test for exposure effects. Analyses were conducted February 2018.
RESULTS


Analyses restricted to those with baseline firearm access (n = 195) identified no significant changes for intentions or safe storage practices across exposure groups. At baseline, participants' attitudes and beliefs were generally supportive of safe firearm storage. The Firearm Safety message yielded small increases in agreement with the concept that secure storage is ""important during emotional or stressful times"" (0.36; 95% CI = 0.08, 0.64). Other significant changes in awareness and beliefs were found, but across all study conditions.
CONCLUSION


Results reinforce the critical need for considerable research and testing prior to the widespread implementation of public messages to increase the likelihood for desired exposure effects.",2019,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","['U.S. military veterans', 'U.S. veterans, a group at elevated risk for firearm suicide', 'A national random sample of U.S. veterans (N\u202f=\u202f358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults']","['public messaging', 'firearm safety message only (n\u202f=\u202f115); (b) firearm safety and mental health promotion messages (n\u202f=\u202f133); or (c) active control group exposed to mental health promotion message']","['awareness and beliefs', 'intentions or safe storage practices', 'awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0646168,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karras', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Department of Psychiatry, University of Rochester, Rochester, NY, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA. Electronic address: Elizabeth.Karras@va.gov.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Stokes', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Warfield', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'Barth', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bossarte', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA; Department of Behavioral Medicine and Psychiatry, School of Medicine, West Virginia University, Morgantown, WV, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.001']
2998,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
2999,31266826,Proteomic Analysis of Plasma Reveals Fat Mass Influences Cancer-Related Pathways in Healthy Humans Fed Controlled Diets Differing in Glycemic Load.,"Increased adiposity and diets high in glycemic load (GL) are associated with increased risk of many chronic diseases including cancer. Using plasma from 80 healthy individuals [40 men/40 women, 29 with DXA-derived low fat mass (FM) and 51 with high FM] in a randomized cross-over-controlled feeding trial and arrays populated with 3,504 antibodies, we measured plasma proteins collected at baseline and end of each of two 28-day controlled diets: a low GL diet high in whole grains, legumes, fruits, and vegetables (WG) and a high GL diet high in refined grains and added sugars (RG). Following univariate testing for proteins differing by diet, we evaluated pathway-level involvement. Among all 80 participants, 172 proteins were identified as differing between diets. Stratifying participants by high and low FM identified 221 and 266 proteins, respectively, as differing between diets (unadjusted  P  < 0.05). These candidate proteins were tested for overrepresentation in Reactome pathways, corresponding to 142 (of 291) pathways in the high-FM group and 72 (of 274) pathways in the low-FM group. We observed that the cancer-related pathways,  DNA Repair, DNA Replication , and  Cell Cycle , were overrepresented in the high-FM participants while pathways involved in post-translational protein modification were overrepresented in participants with either FM. Although high-GL diets are associated with increased risk of some cancers, our study further suggests that biology associated with consumption of GL diets is variable depending on an individual's adiposity and dietary recommendations related to cancer prevention be made with the additional consideration of an individual's FM.",2019,Stratifying participants by high and low FM identified 221 and 266 proteins respectively as differing between diets (unadjusted p<0.05).,"['healthy humans fed controlled diets differing in glycemic load', '80 healthy individuals [40 men/40 women, 29 with DXA-derived low-fat mass (FM) and 51 with high FM', 'Among all 80 participants, 172 proteins were identified as differing between diets']","['low GL diet high in whole grains, legumes, fruits, and vegetables (WG) and a high GL diet high in refined grains and added sugars (RG']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0453184', 'cui_str': 'Legumes'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]",[],172.0,0.0369332,Stratifying participants by high and low FM identified 221 and 266 proteins respectively as differing between diets (unadjusted p<0.05).,"[{'ForeName': 'Carly B', 'Initials': 'CB', 'LastName': 'Garrison', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Meredith A J', 'Initials': 'MAJ', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kratz', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. jlampe@fredhutch.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0175']
3000,31840247,High-definition transcranial direct current stimulation dissociates fronto-visual theta lateralization during visual selective attention.,"KEY POINTS


Visual attention involves discrete multispectral oscillatory responses in visual and 'higher-order' prefrontal cortices. Prefrontal cortex laterality effects during visual selective attention are poorly characterized. High-definition transcranial direct current stimulation dynamically modulated right-lateralized fronto-visual theta oscillations compared to those observed in left fronto-visual pathways. Increased connectivity in right fronto-visual networks after stimulation of the left dorsolateral prefrontal cortex resulted in faster task performance in the context of distractors. Our findings show clear laterality effects in theta oscillatory activity along prefrontal-visual cortical pathways during visual selective attention.
ABSTRACT


Studies of visual attention have implicated oscillatory activity in the recognition, protection and temporal organization of attended representations in visual cortices. These studies have also shown that higher-order regions such as the prefrontal cortex are critical to attentional processing, but far less is understood regarding prefrontal laterality differences in attention processing. To examine this, we selectively applied high-definition transcranial direct current stimulation (HD-tDCS) to the left or right dorsolateral prefrontal cortex (DLPFC). We predicted that HD-tDCS of the left versus right prefrontal cortex would differentially modulate performance on a visual selective attention task, and alter the underlying oscillatory network dynamics. Our randomized crossover design included 27 healthy adults that underwent three separate sessions of HD-tDCS (sham, left DLPFC and right DLPFC) for 20 min. Following stimulation, participants completed an attention protocol during magnetoencephalography. The resulting oscillatory dynamics were imaged using beamforming, and peak task-related neural activity was subjected to dynamic functional connectivity analyses to evaluate the impact of stimulation site (i.e. left and right DLPFC) on neural interactions. Our results indicated that HD-tDCS over the left DLPFC differentially modulated right fronto-visual functional connectivity within the theta band compared to HD-tDCS of the right DLPFC and further, specifically modulated the oscillatory response for detecting targets among an array of distractors. Importantly, these findings provide network-specific insight into the complex oscillatory mechanisms serving visual selective attention.",2020,Increased connectivity in right fronto-visual networks after stimulation of the left DLPFC resulted in faster task performance in the context of distractors.,['27 healthy adults'],"['high-definition transcranial direct-current stimulation (HD-tDCS', 'HD-tDCS (sham, left- and right-DLPFC', 'attention paradigm during magnetoencephalography (MEG']","['faster task performance', 'HD-tDCS dynamically modulated right-lateralized fronto-visual theta oscillations', 'right fronto-visual functional connectivity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",27.0,0.0470895,Increased connectivity in right fronto-visual networks after stimulation of the left DLPFC resulted in faster task performance in the context of distractors.,"[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Spooner', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Eastman', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rezich', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Tony W', 'Initials': 'TW', 'LastName': 'Wilson', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}]",The Journal of physiology,['10.1113/JP278788']
3001,31821071,"CYP2D6  Genotype-Guided Tamoxifen Dosing in Hormone Receptor-Positive Metastatic Breast Cancer (TARGET-1): A Randomized, Open-Label, Phase II Study.","PURPOSE


In patients taking tamoxifen, the  CYP2D6  genotype causes different exposure of active metabolite endoxifen. The objective of this randomized, open-label, multicenter, phase II study was to prospectively evaluate whether  CYP2D6  genotype-guided tamoxifen dosing in patients with hormone receptor-positive metastatic breast cancer could have an impact on the clinical outcome.
METHODS


Patients who needed first-line tamoxifen therapy were enrolled. Based on individual  CYP2D6  genotype, patients heterozygous (wild type [wt]/variant [V]) or homozygous (V/V) for variant alleles of decreased or no function were randomly assigned to receive tamoxifen at an increased dose (ID arm; 40 mg daily) or regular dose (RD arm; 20 mg daily), and patients homozygous for wild-type alleles (wt/wt) received tamoxifen at 20 mg daily. The primary endpoint was the progression-free survival (PFS) rate at 6 months. The secondary endpoints included PFS and correlation of Z-endoxifen concentration with clinical outcomes.
RESULTS


Between December 2012 and July 2016, 186 patients were enrolled in Japan. Of 184 evaluable patients, 136 carried wt/V or V/V (ID arm, 70; RD arm, 66), and 48 carried wt/wt. PFS rates at 6 months were not significantly different between the ID and RD arms (67.6%  v  66.7%). The serum trough concentrations of Z-endoxifen in the ID arm were significantly higher than those in the RD arm (median, 89.2 nM  v  51.1 nM;  P  < .0001) and were also higher compared with wt/wt patients (72.0 nM;  P  = .045). No significant difference in Z-endoxifen concentrations was observed between patients with disease progression and those who were progression free at 6 months ( P  = .43).
CONCLUSION


In patients with  CYP2D6 -variant alleles, increasing tamoxifen dosing did not achieve a higher PFS rate at 6 months. The  CYP2D6  genotype solely cannot explain individual variability in the efficacy of tamoxifen.",2020,"No significant difference in Z-endoxifen concentrations was observed between patients with disease progression and those who were progression free at 6 months ( P  = .43).
","['patients heterozygous (wild type [wt]/variant [V]) or homozygous (V/V) for variant alleles of decreased or no function', 'Between December 2012 and July 2016', 'Patients who needed first-line tamoxifen therapy were enrolled', '184 evaluable patients, 136 carried wt/V or V/V (ID arm, 70; RD arm, 66), and 48 carried wt/wt', 'patients with hormone receptor-positive metastatic breast cancer', '186 patients were enrolled in Japan', 'Hormone Receptor-Positive Metastatic Breast Cancer (TARGET-1']","['CYP2D6  Genotype-Guided Tamoxifen', 'CYP2D6  genotype-guided tamoxifen', 'tamoxifen']","['PFS and correlation of Z-endoxifen concentration with clinical outcomes', 'serum trough concentrations of Z-endoxifen', 'Z-endoxifen concentrations', 'progression-free survival (PFS) rate', 'PFS rate', 'PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0957573', 'cui_str': '4-hydroxy-N-desmethyltamoxifen, (Z)-isomer'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",136.0,0.0561009,"No significant difference in Z-endoxifen concentrations was observed between patients with disease progression and those who were progression free at 6 months ( P  = .43).
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Chiyo K', 'Initials': 'CK', 'LastName': 'Imamura', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Yonemori', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Kindai University, Osaka, Japan.'}, {'ForeName': 'Reiki', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Kumamoto Shinto General Hospital, Kumamoto, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Tokyo-West Tokushukai Hospital, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kitani', 'Affiliation': 'Seirei Sakura Citizen Hospital, Chiba, Japan.'}, {'ForeName': 'Naoto T', 'Initials': 'NT', 'LastName': 'Ueno', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Taisei', 'Initials': 'T', 'LastName': 'Mushiroda', 'Affiliation': 'RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Kubo', 'Affiliation': 'RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tanigawara', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01412']
3002,31581836,Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study.,"BACKGROUND/AIM


Cost-efficient methods are essential for successful participant recruitment in clinical trials. Patient portal messages are an emerging means of recruiting potentially eligible patients into trials. We assessed the response rate and complaint rate from direct-to-patient, targeted recruitment through patient portals of an electronic medical record for a clinical trial, and compared response rates by differences in message content.
METHODS


The Study to Understand Fall Reduction and Vitamin D in You (STURDY) trial is a National Institutes of Health-sponsored, community-based study of vitamin D supplementation for fall prevention in older adults conducted at Johns Hopkins. Potential participants were identified using the Epic electronic medical record at the Johns Hopkins Health System based on age (≥70 years), ZIP code (30-mile radius of study site), and prior activation of a patient portal account. We prepared a shorter message and a longer message. Both had basic information about study participation, but the longer message also contained information about the significance of the study and a personal invitation from the STURDY principal investigator. The Hopkins Institutional Review Board did not require prior consent from the patient or their providers. We calculated the response rate and tracked the number of complaints and requests for removal from future messages. We also determined response rate according to message content.
RESULTS


Of the 5.5 million individuals receiving care at the Johns Hopkins Health System, a sample of 6896 met our inclusion criteria and were sent one patient portal recruitment message between 6 April 2017 and 3 August 2017. Assessment of enrollment by this method ended on 1 December 2017. There were 116 patients who expressed interest in the study (response rate: 1.7%). Twelve (0.2%) recipients were randomized. There were two complaints (0.03%) and one request to unsubscribe from future recruitment messages (0.01%). Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%;  p  = 0.005).
CONCLUSION


Patient portal messages inviting seniors to participate in a randomized controlled trial resulted in a response rate similar to commercial email marketing and resulted in very few complaints or opt-out requests. Furthermore, a longer message with more content enhanced response rate. Recruitment through patient portals might be an effective strategy to enroll trial participants.",2020,"Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%;  p  = 0.005).
","['a sample of 6896 met our inclusion criteria and were sent one patient portal recruitment message between 6 April 2017 and 3 August 2017', '116 patients who expressed interest in the study (response rate: 1.7', 'older adults conducted at Johns Hopkins', 'Potential participants were identified using the Epic electronic medical record at the Johns Hopkins Health System based on age (≥70\u2009years), ZIP code (30-mile radius of study site), and prior activation of a patient portal account']",['vitamin D supplementation'],"['Response rate', 'response rate and complaint rate']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0453984', 'cui_str': 'Zipper'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]",116.0,0.259268,"Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%;  p  = 0.005).
","[{'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine, The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Kelly T', 'Initials': 'KT', 'LastName': 'Gleason', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Hailey N', 'Initials': 'HN', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McArthur', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl Dennison', 'Initials': 'CD', 'LastName': 'Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Lazo', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Ford', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774519873657']
3003,31592329,Effect of vitamin D on serum markers of bone turnover in SLE in a randomised controlled trial.,"Objective


Bone health in SLE is adversely affected by vitamin D deficiency, inflammatory cytokines and glucocorticoid use. We hypothesised that vitamin D supplementation would increase markers of bone formation and decrease markers of bone resorption in SLE subjects.
Methods


We studied 43 vitamin D-deficient SLE subjects who participated in a 12-week randomised controlled trial of 2000-4000 IU/day vitamin D supplementation versus placebo. Subjects had inactive SLE (SLE Disease Activity Index ≤4) and were taking <20 mg prednisone daily at baseline. We assayed baseline and week 12 serum 25-hydroxyvitamin D, N-terminal propeptide of type 1 collagen (P1NP) and C-telopeptide (CTX). We tested the effect of vitamin D versus placebo on change (Δ) in P1NP and ΔCTX in an intention-to-treat analysis. Secondary analyses evaluated whether vitamin D affected bone turnover among subjects achieving vitamin D repletion (≥30 ng/mL) or currently taking glucocorticoids.
Results


28 subjects were randomised to vitamin D and 15 to placebo. Mean age was 39 years and 40% were using glucocorticoids at enrolment. Repletion was achieved by 46% in the vitamin D group versus none in the placebo group. Changes in bone turnover markers were not significantly different in the vitamin D group versus placebo group (median ΔP1NP -0.2 vitamin D group vs -1.1 placebo group (p=0.83); median ΔCTX +3.5 vitamin D group vs -37.0 placebo group (p=0.50)). The effect of vitamin D did not differ based on achieving vitamin D repletion or baseline glucocorticoid use.
Conclusion


Vitamin D supplementation did not affect the 12-week change in bone turnover markers among SLE subjects in this trial.",2019,Changes in bone turnover markers were not significantly different in the vitamin D group versus placebo group (median ΔP1NP -0.2 vitamin D group vs -1.1 placebo group (p=0.83); median ΔCTX +3.5 vitamin D group vs -37.0 placebo group (p=0.50)).,"['Mean age was 39 years and 40% were using glucocorticoids at enrolment', 'Subjects had inactive SLE', '43 vitamin D-deficient SLE subjects who participated', '28 subjects']","['vitamin D versus placebo', 'vitamin D supplementation', 'placebo', 'P1NP and ΔCTX', 'Vitamin D supplementation', 'vitamin D', 'vitamin D supplementation versus placebo']","['bone formation', 'Repletion', 'bone resorption', 'serum markers of bone turnover', 'vitamin D affected bone turnover', 'bone turnover markers', 'serum 25-hydroxyvitamin D, N-terminal propeptide of type 1 collagen (P1NP) and C-telopeptide (CTX']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]",28.0,0.703605,Changes in bone turnover markers were not significantly different in the vitamin D group versus placebo group (median ΔP1NP -0.2 vitamin D group vs -1.1 placebo group (p=0.83); median ΔCTX +3.5 vitamin D group vs -37.0 placebo group (p=0.50)).,"[{'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Kamen', 'Affiliation': 'Division of Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'LeBoff', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}]",Lupus science & medicine,['10.1136/lupus-2019-000352']
3004,31338640,"Impact of a topical lotion, CG428, on permanent chemotherapy-induced alopecia in breast cancer survivors: a pilot randomized double-blind controlled clinical trial (VOLUME RCT).","PURPOSE


This study aimed to evaluate the impact of a topical lotion (CG428) on hair thickness and density in breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA).
METHODS


The study was a double-blind, randomized controlled trial which conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea. Breast cancer patients with PCIA were randomized on average of 3.5 years after chemotherapy. Topical lotion (Batch DT023) is a botanical drug under development containing a novel patented blend of 4 botanical ingredients: citrus, cocoa, guarana, and onion. Participants were asked to self-apply the study product or placebo twice per day for 6 months. Changes in hair density and thickness were assessed using a noninvasive bioengineering device, and patient-reported outcomes were evaluated at 3 and 6 months after randomization.
RESULTS


A total of 35 patients were randomized to intervention (N = 18) or placebo (N = 17). Patients in the intervention group were older than those in the placebo group (52.1 vs. 41.6 years; P < 0.001). The mean hair density (SD) at baseline was 97.6 (6.4) and 126.8 (30.3) hairs/cm 2  in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23). Similar findings were observed after age adjustment.
DISCUSSION


In this pilot randomized clinical trial, we observed safety, tolerability, and a trend toward the efficacy of CG428 vs. placebo, especially regarding hair density and self-reported improvement.",2020,"Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23).","['35 patients', 'Breast cancer patients with PCIA', 'breast cancer survivors', 'breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA', 'conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea']","['topical lotion (CG428', 'permanent chemotherapy-induced alopecia', 'CG428 vs. placebo', 'placebo', 'topical lotion, CG428', 'Topical lotion (Batch DT023']","['hair density and thickness', 'hair density', 'safety, tolerability', 'mean hair density (SD', 'hair thickness and density', 'corresponding values for hair thickness', 'hair thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C0991552', 'cui_str': 'Topical Lotion'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.617278,"Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23).","[{'ForeName': 'Danbee', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.'}, {'ForeName': 'Im-Ryung', 'Initials': 'IR', 'LastName': 'Kim', 'Affiliation': 'Cancer Education Center, Samsung Comprehensive Cancer Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Young Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Departments of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St, Baltimore, MD, USA.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Guallar', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea. jinseok.ahn@samsung.com.'}, {'ForeName': 'Juhee', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea. jcho@skku.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04982-z']
3005,32115598,Participatory science for coastal water quality: freshwater plume mapping and volunteer retention in a randomized informational intervention.,"Among the biggest threats to coastal water quality are freshwater discharges. It is difficult to predict the spatial extent of freshwater plumes at marine beaches because processes governing mass transport in the surf zone are complex. Participatory science approaches could facilitate collecting shoreline data, although volunteer sampling campaigns can be challenged by data quality and volunteer retention. The goals of this study were to (1) work with volunteers to estimate safe swimming distances at beaches that receive polluted discharges, and (2) test whether informational feedback to volunteers increased retention. Forty-six volunteers participated over 12 weeks in 2019 by collecting 1452 salinity measurements at beaches near the mouths of two Central California freshwater discharges and completing participation surveys. These measurements resulted in 145 distinct estimates of safe swimming distances (D90), spanning a range of environmental conditions during rainy and dry periods. Median D90s were 150 and 100 m at San Pedro Creek south and north, and 490 and 330 m at San Lorenzo River west and east, respectively. D90 was significantly associated with adjacent freshwater discharge rate at both discharges and tide level at one discharge. On average, the odds of volunteers conducting sampling decreased by 4% (95% CI: 1%, 7%) with each successive week. A randomized intervention providing repeated data feedback via email to volunteers did not affect their retention in the study.",2020,"On average, the odds of volunteers conducting sampling decreased by 4% (95% CI: 1%, 7%) with each successive week.",['Forty-six volunteers participated over 12 weeks in 2019 by collecting 1452 salinity measurements at beaches near the mouths of two Central California freshwater discharges and completing participation surveys'],[],"['safe swimming distances (D90), spanning a range of environmental conditions', 'adjacent freshwater discharge rate']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1956027', 'cui_str': 'Salinity'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0016710', 'cui_str': 'Freshwater'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0016710', 'cui_str': 'Freshwater'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",46.0,0.0584207,"On average, the odds of volunteers conducting sampling decreased by 4% (95% CI: 1%, 7%) with each successive week.","[{'ForeName': 'Wiley C', 'Initials': 'WC', 'LastName': 'Jennings', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, 473 Via Ortega, Room 189, Stanford, California 94305, USA. aboehm@stanford.edu.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Cunniff', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Deres', 'Affiliation': ''}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Reineman', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Alexandria B', 'Initials': 'AB', 'LastName': 'Boehm', 'Affiliation': ''}]",Environmental science. Processes & impacts,['10.1039/c9em00571d']
3006,31984668,The WORD: Outcomes of a Behavioral Weight Loss Maintenance Effectiveness Trial in Rural Black Adults of Faith.,"OBJECTIVE


Rural black communities bear a disproportionate burden of obesity. To increase reach among underserved groups, community-based weight loss and maintenance interventions are crucial.
METHODS


The Diabetes Prevention Program (DPP) was adapted for rural black adults of faith to create The Wholeness, Oneness, Righteousness, Deliverance (WORD) trial, a group-based, community health worker-delivered weight loss intervention. A Weight Loss Only arm (16 sessions) was compared with a Weight Loss + Maintenance arm (16 + 12 sessions) in a cluster randomized controlled trial of 31 churches (n = 440). Weight and related behaviors were assessed at 0, 6, 12, and 18 months.
RESULTS


The WORD produced weight loss from baseline to 6 months (percentage body weight change -2.47 [-3.13 to -1.80]). Among those who lost 5% of their baseline weight, there was a statistical trend of lower weight regain in the Weight Loss + Maintenance arm compared with control. Maintenance arm participants reported higher activity at 12 months. There were no between-arm differences at 18 months.
CONCLUSIONS


The WORD produced weight loss from baseline to 6 months on par with that produced by other DPP adaptations for black communities, including adaptations using health professionals. Weight regain was also consistent with that reported in prior literature. Continuing sessions as part of the church's mission may foster adoption of DPP-based weight loss programs.",2020,"There were no between-arm differences at 18 months.
","['rural black adults of faith to create The Wholeness, Oneness, Righteousness, Deliverance (WORD) trial, a group-based, community health worker-delivered weight loss intervention', 'Rural Black Adults of Faith', 'Rural black communities bear a disproportionate burden of obesity']","['Diabetes Prevention Program (DPP', 'Behavioral Weight']","['Weight and related behaviors', 'WORD produced weight loss', 'weight regain', 'Weight regain']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205350', 'cui_str': 'Disproportionate (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0311129,"There were no between-arm differences at 18 months.
","[{'ForeName': 'Karen H Kim', 'Initials': 'KHK', 'LastName': 'Yeary', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Cornell', 'Affiliation': 'Health Education and Health Behavior Department, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Page C', 'Initials': 'PC', 'LastName': 'Moore', 'Affiliation': 'Corrona, LLC, Washington, D.C., USA.'}, {'ForeName': 'C Heath', 'Initials': 'CH', 'LastName': 'Gauss', 'Affiliation': 'Health Education and Health Behavior Department, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'T Elaine', 'Initials': 'TE', 'LastName': 'Prewitt', 'Affiliation': 'Health Education and Health Behavior Department, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Boys, Girls, Adults Community Development Center, Marvell, Arkansas, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22717']
3007,31184266,Music Therapy for Pain and Anxiety Management in Nasal Bone Fracture Reduction: Randomized Controlled Clinical Trial.,"OBJECTIVE


To evaluate whether listening to music through binaural headphones contributes to the perception of pain and anxiety in patients undergoing closed nasal bone fracture reductions.
STUDY DESIGN


Randomized controlled trial.
SUBJECTS AND METHODS


We recruited patients from San Juan de Dios Hospital with displaced nasal fractures who required a reduction and assigned them to a control group or a music group. For both groups, a protocolized closed reduction of the nasal fracture with local anesthesia was performed. The music group heard music through headphones during the pre-, intra-, and postprocedural periods of the intervention. Physiological variables (blood pressure and heart rate) were measured. An anxiety survey (State-Trait Anxiety Inventory) and the visual analog scale for measuring pain were also applied.
RESULTS


The music group exhibited significantly lower levels of systolic blood pressure ( P  = .0001), anxiety ( P  < .0001), and pain ( P  = .0004) than the control group.
CONCLUSION


Listening to music through headphones-a safe and low-cost intervention-appears to aid in pain and anxiety management associated with procedures that are usually uncomfortable, such as the reduction of nasal bone fractures with local anesthesia. We believe that this effect is achieved by the modulation of pain and anxiety on an emotional-affective dimension at a central level. Given its safety, feasibility, and low cost, music therapy should be considered a complementary treatment for pain and anxiety management for nasal fracture reduction performed with local anesthesia, as well as for other medical procedures of similar pain levels conducted without general anesthesia.",2019,"The music group exhibited significantly lower levels of systolic blood pressure ( P = .0001), anxiety ( P < .0001), and pain ( P = .0004) than the control group.
","['Nasal Bone Fracture Reduction', 'patients undergoing closed nasal bone fracture reductions', 'We recruited patients from San Juan de Dios Hospital with displaced nasal fractures who required a reduction and assigned them to a control group or a music group']","['music group heard music through headphones', 'Music Therapy', 'listening to music through binaural headphones']","['pain', 'Physiological variables (blood pressure and heart rate', 'levels of systolic blood pressure', 'pain and anxiety', 'anxiety', 'anxiety survey (State-Trait Anxiety Inventory']","[{'cui': 'C0027422', 'cui_str': 'Nasal Bone'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.0851245,"The music group exhibited significantly lower levels of systolic blood pressure ( P = .0001), anxiety ( P < .0001), and pain ( P = .0004) than the control group.
","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Ortega', 'Affiliation': 'Department of Otorhinolaryngology, San Juan de Dios Hospital, Santiago, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Gauna', 'Affiliation': 'Department of Otorhinolaryngology, San Juan de Dios Hospital, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Munoz', 'Affiliation': 'Department of Otorhinolaryngology, San Juan de Dios Hospital, Santiago, Chile.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Oberreuter', 'Affiliation': 'Department of Otorhinolaryngology, San Juan de Dios Hospital, Santiago, Chile.'}, {'ForeName': 'Hayo A', 'Initials': 'HA', 'LastName': 'Breinbauer', 'Affiliation': 'Department of Otorhinolaryngology, San Juan de Dios Hospital, Santiago, Chile.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Carrasco', 'Affiliation': 'Department of Otorhinolaryngology, San Juan de Dios Hospital, Santiago, Chile.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599819856604']
3008,31400105,An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial.,"BACKGROUND


App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined.
OBJECTIVE


This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers.
METHODS


A 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was conducted through preschools, which were randomly allocated to either the control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention). A total of 2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools. The primary outcome was unintentional injury incidences among preschoolers in the past 3 months; this measure was assessed through an online caregiver-report at the baseline visit and at 3-month and 6-month follow-up visits. Secondary outcome measures included caregivers' self-reported attitudes and behaviors concerning child supervision during the last week. Generalized estimating equations (GEEs) were used to assess the effectiveness of the app-based intervention on responses at 3 and 6 months after adjusting for sociodemographic variables, baseline level of the outcome variable, and engagement with interventions in the assigned group. All analyses were intention-to-treat. A per-protocol sensitivity analysis was also conducted.
RESULTS


In total, 1980 of the 2920 caregivers completed the study. The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female. During the 6-month follow-up visit, unintentional injury incidence did not change significantly in either group: incidence in the intervention group went from 8.76% (94/1073) to 8.11% (87/1073), P=.59; incidence in the control group went from 9.4% (85/907) to 7.5% (69/907), P=.15. The changes did not differ between the groups (odds ratio [OR] 1.14, 95% CI 0.80-1.62). Changes in the average score in attitude concerning unintentional injury prevention were also similar between the groups (B .05, 95% CI -0.03 to 0.13). Changes in unintentional injury prevention behaviors were greater in the intervention group than in the control group after the intervention (B .87, 95% CI 0.33-1.42). Analyses of individual injury prevention behaviors showed that the intervention reduced three risky behaviors: unsafe feeding of children (OR 0.73, 95% CI 0.60-0.89); incorrectly placing children in cars (OR 0.73, 95% CI 0.57-0.93); and allowing children to ride bicycles, electric bicycles, or motorcycles unsupervised (OR 0.80, 95% CI 0.64-0.99). The intervention also improved scores on three safety-focused behaviors: testing water temperature before giving children a bath (OR 1.26, 95% CI 1.05-1.52); properly storing sharp objects (OR 1.24, 95% CI 1.01-1.52); and safely storing medicines, detergents, and pesticides (OR 1.24, 95% CI 1.02-1.51).
CONCLUSIONS


The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers' safety behaviors. This app-based intervention approach to improve caregiver behaviors surrounding child injury risk offers promise to be modified and ultimately disseminated broadly.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 (Archived by WebCite at http://www.webcitation.org/75jt17X84).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12889-018-5790-1.",2019,The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers' safety behaviors.,"['caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers', 'December 2017 to June 2018', 'The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female', '2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools', 'In total, 1980 of the 2920 caregivers completed the study', 'Preschoolers']","['app-based intervention', 'control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention']","['unintentional injury incidences', 'unintentional injury incidence', 'safety-focused behaviors: testing water temperature', 'unintentional injury prevention behaviors', ""caregivers' safety behaviors"", 'Unintentional Injury', 'risky behaviors: unsafe feeding of children', ""caregivers' self-reported attitudes and behaviors concerning child supervision during the last week""]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",2920.0,0.221008,The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers' safety behaviors.,"[{'ForeName': 'Peishan', 'Initials': 'P', 'LastName': 'Ning', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Peixia', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions, Emerging Pathogen Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Renhe', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Shukun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Information and Network Center, Central South University, Changsha, China.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}]",JMIR mHealth and uHealth,['10.2196/13519']
3009,32114641,Diets naturally rich in polyphenols and/or long-chain n-3 polyunsaturated fatty acids differently affect microbiota composition in high-cardiometabolic-risk individuals.,"AIMS


Gut microbiota significantly impacts human health and is influenced by dietary changes. We evaluated the effects of diets naturally rich in polyphenols (PP) and/or long-chain n-3 polyunsaturated fatty acids (LCn3) on microbiota composition in an ancillary analysis of a randomized controlled trial in individuals at high cardiometabolic risk.
METHODS


Seventy-eight individuals with high waist circumference and at least one additional component of the metabolic syndrome were randomized to an isoenergetic 8-week diet: (a) low LCn3 and PP; (b) high LCn3; (c) high PP; or (d) high LCn3 and PP. Microbiota analysis was performed on feces collected before and after the intervention. DGGE analysis of the predominant bacteria, Eubacterium rectale and Blautia coccoides group (Lachnospiraceae, EREC), Clostridium leptum (Ruminococcaceae, CLEPT), Bacteroides spp., Bifidobacteria, and Lactobacillus group was performed. A quantitative real-time PCR was performed for the same group, additionally including Atopobium cluster (Coriobatteriaceae). Before and after the intervention, participants underwent a 75 g OGTT and a high-fat test meal to evaluate glucose and lipid response.
RESULTS


Adherence to the four diets was optimal. PP significantly increased microbial diversity (p = 0.006) and CLEPT (p = 0.015), while it reduced EREC (p = 0.044). LCn3 significantly increased the numbers of Bifidobacteria (p = 0.041). Changes in CLEPT numbers correlated with changes in early insulin secretion (r = 0.263, p = 0.030). Changes in Atopobium numbers correlated with postprandial triglycerides in plasma (r = 0.266, p = 0.026) and large VLDL (r = 0.313, p = 0.009), and cholesterol in large VLDL (r = 0.319, p = 0.008).
CONCLUSIONS


Diets naturally rich in PP or LCn3 influenced gut microbiota composition in individuals at high cardiometabolic risk. These modifications were associated with changes in glucose/lipid metabolism.",2020,"PP significantly increased microbial diversity (p = 0.006) and CLEPT (p = 0.015), while it reduced EREC (p = 0.044).","['Seventy-eight individuals with high waist circumference and at least one additional component of the metabolic syndrome', 'individuals at high cardiometabolic risk', 'high-cardiometabolic-risk individuals']","['isoenergetic 8-week diet: (a) low LCn3 and PP; (b) high LCn3; (c) high PP; or (d) high LCn3 and PP', 'Diets naturally rich in polyphenols and/or long-chain n-3 polyunsaturated fatty acids', 'LCn3', 'diets naturally rich in polyphenols (PP) and/or long-chain n-3 polyunsaturated fatty acids (LCn3']","['numbers of Bifidobacteria', 'gut microbiota composition', 'cholesterol in large VLDL', 'early insulin secretion', 'postprandial triglycerides in plasma', 'microbial diversity', 'glucose/lipid metabolism', 'large VLDL']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",78.0,0.0267186,"PP significantly increased microbial diversity (p = 0.006) and CLEPT (p = 0.015), while it reduced EREC (p = 0.044).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Maukonen', 'Affiliation': 'VTT Technical Research Centre of Finland, Espoo, Finland.'}, {'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Costabile', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy. rivelles@unina.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saarela', 'Affiliation': 'VTT Technical Research Centre of Finland, Espoo, Finland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}]",Acta diabetologica,['10.1007/s00592-020-01494-9']
3010,30341058,Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy.,"Risk of hepatitis B virus (HBV) reactivation was assessed in B-cell non-Hodgkin lymphoma (NHL) patients with resolved HBV infection (hepatitis B surface antigen negative, hepatitis B core antibody positive) who received obinutuzumab- or rituximab-containing immunochemotherapy in the phase 3 GOYA and GALLIUM studies. HBV DNA monitoring was undertaken monthly to 1 year after the last dose of study drug. In case of HBV reactivation (confirmed, HBV DNA ≥29 IU/mL), immunochemotherapy was withheld and nucleos(t)ide analog treatment (preemptive NAT) started. Immunochemotherapy was restarted if HBV DNA became undetectable or reactivation was not confirmed, and discontinued if HBV DNA exceeded 100 IU/mL on NAT. Prophylactic NAT was allowed by investigator discretion. Among 326 patients with resolved HBV infection, 27 (8.2%) had HBV reactivation, occurring a median of 125 days (interquartile range, 85-331 days) after the first dose. In 232 patients without prophylactic NAT, 25 (10.8%) had HBV reactivation; all received preemptive NAT. Ninety-four patients received prophylactic NAT; 2 (2.1%) had HBV reactivation. No patients developed HBV-related hepatitis. On multivariate Cox analysis, detectable HBV DNA at baseline was strongly associated with an increased risk of reactivation (adjusted hazard ratio [HR], 18.22; 95% confidence interval [CI], 6.04-54.93;  P  < .0001). Prophylactic NAT was strongly associated with a reduced risk (adjusted HR, 0.09; 95% CI, 0.02-0.41;  P  = .0018). HBV DNA monitoring-guided preemptive NAT was effective in preventing HBV-related hepatitis during anti-CD20-containing immunochemotherapy in B-cell NHL patients with resolved HBV infection. Antiviral prophylaxis was also effective and may be appropriate for high-risk patients. These trials were registered at www.clinicaltrials.gov as NCT01287741 (GOYA) and NCT01332968 (GALLIUM).",2019,"On multivariate Cox analysis, detectable HBV DNA at baseline was strongly associated with an increased risk of reactivation (adjusted hazard ratio [HR], 18.22; 95% confidence interval [CI], 6.04-54.93;  P  < .0001).","['326 patients with resolved HBV infection, 27 (8.2%) had', '232 patients without prophylactic NAT, 25 (10.8%) had HBV reactivation; all received', 'patients with B-cell lymphomas receiving', 'B-cell non-Hodgkin lymphoma (NHL) patients with resolved HBV infection (hepatitis B surface antigen negative, hepatitis B core antibody positive) who received']","['obinutuzumab or rituximab immunochemotherapy', 'prophylactic NAT', 'immunochemotherapy', 'preemptive NAT', 'Immunochemotherapy', 'obinutuzumab- or rituximab-containing immunochemotherapy', 'Prophylactic NAT']","['risk of reactivation', 'Risk of hepatitis B virus (HBV) reactivation', 'HBV reactivation', 'HBV-related hepatitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0067787', 'cui_str': 'TalANAc'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0919711', 'cui_str': 'Hepatitis B surface antigen negative (finding)'}, {'cui': 'C0262506', 'cui_str': 'Hepatitis B core antibody positive'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0067787', 'cui_str': 'TalANAc'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}]",326.0,0.0959665,"On multivariate Cox analysis, detectable HBV DNA at baseline was strongly associated with an increased risk of reactivation (adjusted hazard ratio [HR], 18.22; 95% confidence interval [CI], 6.04-54.93;  P  < .0001).","[{'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Arcaini', 'Affiliation': 'Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yok Lam', 'Initials': 'YL', 'LastName': 'Kwong', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Marion G', 'Initials': 'MG', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kuriki', 'Affiliation': 'Clinical Science & Strategy Department, Oncology Clinical Science & Strategy, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'Product Development Oncology, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': 'Product Development Oncology, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ueda', 'Affiliation': 'Clinical Science & Strategy Department, Oncology Clinical Science & Strategy, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Piper-Lepoutre', 'Affiliation': 'Product Development Oncology, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Sellam', 'Affiliation': 'Product Development Oncology, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}]",Blood,['10.1182/blood-2018-04-848044']
3011,32102119,Effectiveness of a simplified reablement program to minimize functional decline in hospitalized older patients.,"AIM


To examine the effects of a simplified reablement program on physical function and quality of life in hospitalized older patients.
METHODS


The randomized controlled trial enrolled 114 older patients aged ≥65 years who, 2 weeks before admission, had been able to walk independently. Patients randomized to the reablement group received supervision and assistance to carry out the simplified reablement program 30 min daily during their hospital stay. Patients in the reminding group received only oral encouragement to continue the reablement program for 30 min daily. The control group received only usual care that included medical intervention consistent with the patient's diagnosis. The main outcome was improvement in physical function, including the modified version of the Katz Activities of Daily Living (ADL) score, Timed Up and Go test (TUG) and Hand Grip Strength (HGS). Secondary outcomes included the EuroQoL 5 Dimension (EQ-5D) Questionnaire and Visual Analog Scale (VAS).
RESULTS


The intervention had no significant effect on the Katz ADL score. However, a significant within-group improvement in TUG occurred in the reminding group and reablement group. In addition, a significant time-dependent improvement in HGS occurred only in the reablement group. With respect to secondary outcomes, the EQ5D score improved significantly only in the reablement group at 3 months after discharge.
CONCLUSIONS


The simplified reablement program may be beneficial to optimize physical function and improve quality of life in hospitalized older patients. It is recommended that health professionals should assist or encourage older patients to do simplified reablement during their hospital stay. Geriatr Gerontol Int 2020; 20: 436-442.",2020,"With respect to secondary outcomes, the EQ5D score improved significantly only in the reablement group at 3 months after discharge.
","['114 older patients aged ≥65\u2009years who, 2\u2009weeks before admission, had been able to walk independently', 'hospitalized older patients']","['supervision and assistance to carry out the simplified reablement program 30\u2009min daily during their hospital stay', 'simplified reablement program', ""control group received only usual care that included medical intervention consistent with the patient's diagnosis""]","['TUG', 'Katz ADL score', 'physical function, including the modified version of the Katz Activities of Daily Living (ADL) score, Timed Up and Go test (TUG) and Hand Grip Strength (HGS', 'physical function and quality of life', 'EQ5D score', 'HGS', 'EuroQoL 5 Dimension (EQ-5D) Questionnaire and Visual Analog Scale (VAS', 'quality of life']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}]","[{'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",114.0,0.0541817,"With respect to secondary outcomes, the EQ5D score improved significantly only in the reablement group at 3 months after discharge.
","[{'ForeName': 'Fang-Wen', 'Initials': 'FW', 'LastName': 'Hu', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Yi-Ting', 'Initials': 'YT', 'LastName': 'Huang', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Huey-Shyan', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'Department of Health-Business Administration, Fooyin University, Kaohsiung City, Taiwan.'}, {'ForeName': 'Ching-Huey', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, College of Health Sciences, Chang Jung Christian University, Tainan City, Taiwan.'}, {'ForeName': 'Mei-Ju', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Senior Service, College of Humanities and Social Science, Southern Taiwan University of Science and Technology, Tainan City, Taiwan.'}, {'ForeName': 'Chia-Ming', 'Initials': 'CM', 'LastName': 'Chang', 'Affiliation': 'Division of Geriatrics and Gerontology, Department of Internal Medicine, National Cheng Kung University, Hospital, College of Medicine, National Cheng Kung University, Tainan City, Taiwan.'}]",Geriatrics & gerontology international,['10.1111/ggi.13891']
3012,30878190,Improving Everyday Functioning in the Old-Old with Working Memory Training.,"OBJECTIVE


The aim of this study was to assess gains related to working memory (WM) training, in the short and long term (9 months after the training), in abilities required in everyday life, and in cognitive measures in old-old adults (aged ≥ 75 years).
METHODS


Thirty-two community-dwelling older adults (aged 75-85 years) were randomly assigned to a training or an active control group. In addition to testing for any specific gains in a WM task similar to the one used in the training (criterion task), we sought transfer effects to: 1) abilities involved in everyday life using objective performance-based tasks (the Everyday Problem Test [EPT] and the Timed Instrumental Activities of Daily Living [TIADL] scale; 2) tasks demanding the comprehension and recall of spatial information and pairing names with faces; and 3) a measure of inhibitory control, that is, recall errors (intrusion errors).
RESULTS


Only the trained group showed specific gains in the criterion task, and in the TIADL in the short term. At follow-up, the trained group maintained gains in the criterion task, and showed transfer effects to everyday problem-solving (in the EPT), and in constructing spatial representations of an environment. The trained group also improved in a cognitive inhibition measure (intrusion errors) at follow-up. No such improvements were seen in the active control group.
CONCLUSION


WM training may be a valid way to help old-old adults preserve at least some abilities related to everyday functioning.",2019,"At follow-up, the trained group maintained gains in the criterion task, and showed transfer effects to everyday problem-solving (in the EPT), and in constructing spatial representations of an environment.","['Old-Old with Working Memory Training', 'old-old adults (aged ≥ 75 years', 'Thirty-two community-dwelling older adults (aged 75-85 years']","['working memory (WM) training', 'WM training', 'training or an active control group']","['Timed Instrumental Activities of Daily Living [TIADL] scale; 2) tasks demanding the comprehension and recall of spatial information and pairing names with faces', 'specific gains', 'cognitive inhibition measure (intrusion errors']","[{'cui': 'C0001795', 'cui_str': 'Oldest Old'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0288135,"At follow-up, the trained group maintained gains in the criterion task, and showed transfer effects to everyday problem-solving (in the EPT), and in constructing spatial representations of an environment.","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borella', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy. Electronic address: erika.borella@unipd.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cantarella', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Carretti', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'De Lucia', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'De Beni', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.01.210']
3013,3056221,Immunochemosurgery as a new approach to reasonable treatment of advanced cancer.,"To evaluate the effectiveness of adjuvant immunochemotherapy in advanced adenocarcinoma of stomach, patients who had undergone radical subtotal gastrectomy for stage III gastric carcinoma were randomized to receive immunochemotherapy or not. For immunotherapy, streptococcus pyogenes preparation (picibanil) was given intramuscularly every week and for chemotherapy, either MFC (mitomycin-C, 5-fluorouracil and cytosine arabinoside) regimen or FME (5-fluorouracil and methyl-CCNU) regimen was given. Immunotherapy was started at the 4th or 5th postoperative day and chemotherapy was started at the 8th to 10th postoperative day. To evaluate the immune status of patients, various immune parameters such as 1-chloro-2, 4-dinitrobenzene (DNCB) test, T-lymphocyte count, PHA- and concanavalin-A stimulated lymphoblastogenesis and antibody dependent cellular cytotoxicity (ADCC) activity were checked before operation and 3 to 4 months after operation. One hundred and thirty-eight patients were chosen for study during a 5-year period. Seventy-four patients received postoperative immunochemotherapy and 64 patients received no further anticancer therapy following operation. All patients had been followed at least for 5 years since they underwent operation. Survival rate and immune status were compared between two groups. Patient characteristics and preoperative values for immune status of two groups were similar to each other. Five-year survival rate of postoperative immunochemotherapy group was 44.6%, whereas that of surgery alone group was 23.4%. The difference is statistically significant (p less than 0.05). All the postoperative values of immune parameters showed more favourable data in the postoperative immunochemotherapy group.(ABSTRACT TRUNCATED AT 250 WORDS)",1988,"Five-year survival rate of postoperative immunochemotherapy group was 44.6%, whereas that of surgery alone group was 23.4%.","['and 64 patients received', 'One hundred and thirty-eight patients were chosen for study during a 5-year period', 'All patients had been followed at least for 5 years since they underwent operation', 'advanced cancer', 'advanced adenocarcinoma of stomach, patients who had undergone radical subtotal gastrectomy for stage III gastric carcinoma']","['no further anticancer therapy', 'immunochemotherapy', 'adjuvant immunochemotherapy', 'MFC (mitomycin-C, 5-fluorouracil and cytosine arabinoside) regimen or FME (5-fluorouracil and methyl-CCNU', 'postoperative immunochemotherapy', 'Immunotherapy']","['survival rate', '1-chloro-2, 4-dinitrobenzene (DNCB) test, T-lymphocyte count, PHA- and concanavalin-A stimulated lymphoblastogenesis and antibody dependent cellular cytotoxicity (ADCC) activity', 'Survival rate and immune status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0030600', 'cui_str': 'Subtotal gastrectomy (procedure)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach (disorder)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0036637', 'cui_str': 'Me-CCNU'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0012459', 'cui_str': 'Dinitrobenzenes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1167909', 'cui_str': 'T lymphocyte count'}, {'cui': 'C0009630', 'cui_str': 'Concanavalin A'}, {'cui': 'C0003272', 'cui_str': 'ADCC'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]",138.0,0.0143093,"Five-year survival rate of postoperative immunochemotherapy group was 44.6%, whereas that of surgery alone group was 23.4%.","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Korea.'}]","Annals of the Academy of Medicine, Singapore",[]
3014,3777838,A study of inhalational sedation with nitrous oxide/oxygen for oral surgery in Hong Kong Chinese.,"Thirty healthy Chinese between 17-36 years undergoing extraction of bilaterally similarly impacted third molars in two visits were randomly given nitrous oxide/oxygen inhalational sedation to supplement local anaesthesia or unsupplemented local anaesthesia for operation on one side and the alternative for the other. The majority in the study had never heard of inhalational sedation being available to supplement local anaesthesia, and when given a chance to experience this method, the majority preferred it to local anaesthesia alone. Supplementation of local anaesthesia with inhalational sedation produced patients who were more relaxed. With both methods, the operating conditions were assessed to be good, with good patient co-operation. Inhalational sedation with nitrous oxide/oxygen had no significant effect on vital signs, intraoperative or post operative adverse effects and patients were street fit within ten minutes of ending sedation.",1986,"Inhalational sedation with nitrous oxide/oxygen had no significant effect on vital signs, intraoperative or post operative adverse effects and patients were street fit within ten minutes of ending sedation.","['oral surgery in Hong Kong Chinese', 'Thirty healthy Chinese between 17-36 years undergoing extraction of bilaterally similarly impacted third molars in two visits']","['local anaesthesia with inhalational sedation', 'inhalational sedation with nitrous oxide/oxygen', 'nitrous oxide/oxygen inhalational sedation to supplement local anaesthesia or unsupplemented local anaesthesia for operation on one side and the alternative for the other', 'nitrous oxide/oxygen']","['vital signs, intraoperative or post operative adverse effects']","[{'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0412777', 'cui_str': 'Inhalational sedation (procedure)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0518766'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0168458,"Inhalational sedation with nitrous oxide/oxygen had no significant effect on vital signs, intraoperative or post operative adverse effects and patients were street fit within ten minutes of ending sedation.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Rodrigo', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3015,30967321,Effectiveness of Shared Decision-Making for Elderly Depressed Minority Primary Care Patients.,"OBJECTIVE


The authors assessed the impact of a shared decision-making (SDM) intervention among elderly depressed minority primary care patients not currently receiving treatment.
METHODS


A total of 202 English and Spanish-speaking primary care participants aged 65 and older who scored positive on the Patient Health Questionnaire-9 (≥10) were randomized at the physician level to receive a brief SDM intervention or usual care (UC). Primary analyses focused on patient adherence to either psychotherapy or antidepressant medication, and reduction in depression severity (Hamilton Depression Rating Scale) over 12 weeks.
RESULTS


Patients randomized to physicians in the SDM condition were significantly more likely than patients of physicians randomized to UC to receive a mental health evaluation or initiate some form of treatment (39% versus 21%), and to adhere to psychotherapy visits over 12 weeks. There were no differences between groups in adherence to antidepressant medication or in reduction of depressive symptoms.
CONCLUSION


Among untreated elderly depressed minority patients from an inner-city municipal hospital, a brief SDM intervention was associated with greater initiation and adherence to psychotherapy. However, low treatment adherence rates across both groups and the intervention's lack of impact on clinical outcomes highlight the need to provide focused and accessible mental health services to patients choosing active treatments.",2019,"There were no differences between groups in adherence to antidepressant medication or in reduction of depressive symptoms.
","['Elderly Depressed Minority Primary Care Patients', 'elderly depressed minority primary care patients not currently receiving treatment', 'untreated elderly depressed minority patients from an inner-city municipal hospital', '202 English and Spanish-speaking primary care participants aged 65 and older who scored positive on the Patient Health Questionnaire-9 (≥10']","['SDM intervention', 'brief SDM intervention or usual care (UC', 'shared decision-making (SDM) intervention']","['depressive symptoms', 'patient adherence to either psychotherapy or antidepressant medication, and reduction in depression severity (Hamilton Depression Rating Scale']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0020013', 'cui_str': 'Hospitals, City, Public-Owned'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}]",202.0,0.039987,"There were no differences between groups in adherence to antidepressant medication or in reduction of depressive symptoms.
","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences (PJR), University of Washington School of Medicine, Seattle. Electronic address: praue@uw.edu.'}, {'ForeName': 'Herbert C', 'Initials': 'HC', 'LastName': 'Schulberg', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (HCS, SB), Weill Cornell Medical College, White Plains, NY.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'Department of Psychiatry (MLB), Geisel School of Medicine at Dartmouth, Hanover, NH.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (HCS, SB), Weill Cornell Medical College, White Plains, NY.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Artis', 'Affiliation': 'Heart & Vascular Institute Cleveland Clinic, Cleveland (AA).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Espejo', 'Affiliation': 'Lincoln Medical and Mental Health Center (ME), Bronx, NY.'}, {'ForeName': 'Idalia', 'Initials': 'I', 'LastName': 'Catalan', 'Affiliation': 'Equity Project Charter School (IC), New York.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': 'Fordham University (SR), Bronx, NY.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.02.016']
3016,32094516,Effects of hybrid-functional electrical stimulation (FES) rowing whole-body exercise on neurologic improvement in subacute spinal cord injury: secondary outcomes analysis of a randomized controlled trial.,"STUDY DESIGN


Secondary outcome measures analysis of a randomized, controlled study.
OBJECTIVE


To assess the effects of hybrid-functional electrical stimulation (FES) rowing on motor and sensory recovery in individuals with spinal cord injury (SCI) 6-18 months post injury.
SETTING


Outpatient rehabilitation network.
METHODS


25 participants 6-12 months after SCI were randomly assigned to hybrid-FES rowing (n = 10) or standard of care (n = 15) groups. The hybrid-FES rowing group completed 6 months of rowing scheduled 3 times per week for 26 weeks at an exercise intensity of 70-85% of maximal heart rate. The standard of care group either participated in an arm ergometer exercise program (n = 6) or a waitlist without an explicit exercise program (n = 9). Changes in motor score and combined sensory score of the International Standards for Neurological Classification of SCI (ISNCSCI) were analyzed.
RESULTS


Both groups demonstrated increases in motor and combined sensory scores, but no significant differences were noted between intervention groups (motor difference mean ↑1.3 (95% CI, -1.9 to 4.4), combined sensory difference mean ↓10 (-30 to 18)). There was an average of 63% adherence to the hybrid-FES rowing protocol, with no significant correlation in changes in motor or combined sensory score in the hybrid-FES rowing group with total distance or time rowed.
CONCLUSIONS


No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.",2020,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"['individuals with spinal cord injury (SCI) 6-18 months post injury', '25 participants 6-12 months after SCI', 'Outpatient rehabilitation network', 'subacute spinal cord injury']","['hybrid-FES rowing', 'hybrid-functional electrical stimulation (FES) rowing', 'hybrid-FES rowing (n\u2009=\u200910) or standard of care', 'hybrid-functional electrical stimulation (FES) rowing whole-body exercise', 'care group either participated in an arm ergometer exercise program (n\u2009=\u20096) or a waitlist without an explicit exercise program']","['motor score and combined sensory score', 'motor and combined sensory scores', 'motor or combined sensory score', 'neurologic improvement']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",25.0,0.116675,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Chou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA. rchou1@partners.org.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Solinsky', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}]",Spinal cord,['10.1038/s41393-020-0445-3']
3017,32023372,Six-Year Follow-up of a Trial of Antenatal Vitamin D for Asthma Reduction.,"BACKGROUND


We previously reported the results of a trial of prenatal vitamin D supplementation to prevent asthma and recurrent wheeze in young children, which suggested that supplementation provided a protective effect at the age of 3 years. We followed the children through the age of 6 years to determine the course of asthma and recurrent wheeze.
METHODS


In this follow-up study, investigators and participants remained unaware of the treatment assignments through the children's sixth birthday. We aimed to determine whether, when maternal levels of 25-hydroxyvitamin D were taken into account, children born to mothers who had received 4400 IU of vitamin D 3  per day during pregnancy (vitamin D group) would have a lower incidence of asthma and recurrent wheeze at the age of 6 years than would those born to mothers who had received 400 IU of vitamin D 3  per day (control group). Time-to-event methods were used to compare the treatment groups with respect to time to the onset of asthma or recurrent wheeze. Multivariate methods were used to compare longitudinal measures of lung function between the treatment groups.
RESULTS


There was no effect of maternal vitamin D supplementation on asthma and recurrent wheeze in either an intention-to-treat analysis or an analysis with stratification according to the maternal 25-hydroxyvitamin D level during pregnancy. There was no effect of prenatal vitamin D supplementation on most of the prespecified secondary outcomes. We found no effects of prenatal supplementation on spirometric indexes. Although there was a very small effect on airway resistance as measured by impulse oscillometry, this finding was of uncertain significance.
CONCLUSIONS


Vitamin D supplementation during the prenatal period alone did not influence the 6-year incidence of asthma and recurrent wheeze among children who were at risk for asthma. (Funded by the National Heart, Lung, and Blood Institute; VDAART ClinicalTrials.gov number, NCT00920621.).",2020,There was no effect of maternal vitamin D supplementation on asthma and recurrent wheeze in either an intention-to-treat analysis or an analysis with stratification according to the maternal 25-hydroxyvitamin D level during pregnancy.,"['children born to mothers who had received 4400 IU of vitamin D 3  per day during pregnancy (vitamin D group) would have a lower incidence of asthma and recurrent wheeze at the age of 6 years than would those born to mothers who had received', 'children who were at risk for asthma', 'young children']","['prenatal supplementation', '25-hydroxyvitamin D', 'prenatal vitamin D supplementation', 'Vitamin D supplementation', 'maternal vitamin D supplementation', '400 IU of vitamin D 3  per day (control group', 'Antenatal Vitamin D']","['airway resistance', 'maternal 25-hydroxyvitamin D level', '6-year incidence of asthma and recurrent wheeze', 'spirometric indexes', 'lung function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4517778', 'cui_str': '4400 (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",,0.125136,There was no effect of maternal vitamin D supplementation on asthma and recurrent wheeze in either an intention-to-treat analysis or an analysis with stratification according to the maternal 25-hydroxyvitamin D level during pregnancy.,"[{'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Stubbs', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Sandel', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Beigelman', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schatz', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa1906137']
3018,30968542,Role of the extent of prophylactic regional lymph node radiotherapy on survival in high-risk neuroblastoma: A report from the COG A3973 study.,"PURPOSE


Neuroblastoma is the most common extracranial solid pediatric malignancy, with poor outcomes in high-risk disease. Standard treatment approaches employ an increasing array of aggressive multimodal therapies, of which local control with surgery and radiotherapy remains a backbone; however, the benefit of broad regional nodal irradiation remains controversial. We analyzed centrally reviewed radiation therapy data from patients enrolled on COG A3973 to evaluate the impact of primary site irradiation and the extent of regional nodal coverage stratified by extent of surgical resection.
METHODS


Three hundred thirty high-risk neuroblastoma patients with centrally reviewed radiotherapy plans were analyzed. Outcome was evaluated by the extent of nodal irradiation. For the 171 patients who also underwent surgery (centrally reviewed), outcome was likewise analyzed according to the extent of resection. Overall survival (OS), event-free survival (EFS), and cumulative incidence of local progression (CILP) were examined by Kaplan-Meier, log-rank test (EFS, OS), and Grey test (CILP).
RESULTS


The five-year CILP, EFS, and OS for all 330 patients receiving radiotherapy on A3973 were 8.5% ± 1.5%, 47.2% ± 3.0%, and 59.7% ± 3.0%, respectively. There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%).
CONCLUSION


Although local control remains a significant component of treatment of high-risk neuroblastoma, our results suggest there is no benefit of extensive lymph node irradiation, irrespective of the extent of surgical resection preceding stem cell transplant.",2019,"There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%).
","['patients enrolled on COG A3973', '171 patients who also underwent surgery (centrally reviewed', '330 patients receiving', 'Three hundred thirty high-risk neuroblastoma patients with centrally reviewed radiotherapy plans were analyzed', 'high-risk neuroblastoma']","['radiotherapy', 'prophylactic regional lymph node radiotherapy']","['degree of surgical resection', 'survival', 'Kaplan-Meier, log-rank test (EFS, OS), and Grey test (CILP', 'Overall survival (OS), event-free survival (EFS), and cumulative incidence of local progression (CILP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",330.0,0.0561755,"There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%).
","[{'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco, California.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Department of Pediatric Oncology/Hematology, Biostatistics Division, Dana-Farber Cancer Institute, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kreissman', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Villablanca', 'Affiliation': 'Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Davidoff', 'Affiliation': ""Department of Surgery, Pediatrics Division, St. Jude's Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'DeSantes', 'Affiliation': 'Department of Pediatrics, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Castleberry', 'Affiliation': 'Department of Pediatrics, University of Alabama Medical Center, Tuscaloosa, Alabama.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'Department of Pediatrics, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Diller', 'Affiliation': ""Department of Pediatric Oncology/Hematology, Dana-Farber Cancer Institute, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Matthay', 'Affiliation': 'Department of Pediatric Hematology-Oncology, University of California, San Francisco, California.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, Section of Hematology/Oncology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Shulkin', 'Affiliation': ""Department of Diagnostic Imaging, Pediatrics Division, St. Jude's Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'von Allmen', 'Affiliation': ""Department of Pediatric Surgery, Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Department of Radiology, University of Washington, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Van Ryn', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'La Quaglia', 'Affiliation': 'Department of Pediatric Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daphne A', 'Initials': 'DA', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}]",Pediatric blood & cancer,['10.1002/pbc.27736']
3019,3890529,Folic acid blinded trial in identical twins with fragile X syndrome.,"Monozygous twin 14-year-old mentally retarded boys with the fragile X syndrome were treated either with 10 mg folic acid by mouth daily or with a placebo for three test periods of 3-month duration each in a blind study. For each twin, tests of cognitive functioning, reading, spelling, and math skills, and linguistic and perceptual skills were compared. Although there was considerable variation in performance on these tests during the two baseline periods, there were no observable beneficial effects of therapy. The routine use of folic acid in patients with established mental retardation and the fragile X syndrome is not indicated.",1985,"Although there was considerable variation in performance on these tests during the two baseline periods, there were no observable beneficial effects of therapy.","['patients with established mental retardation and the fragile X syndrome', 'identical twins with fragile X syndrome', 'Monozygous twin 14-year-old mentally retarded boys with the fragile X syndrome']","['folic acid', 'Folic acid', '10 mg folic acid by mouth daily or with a placebo']","['cognitive functioning, reading, spelling, and math skills, and linguistic and perceptual skills']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0016667', 'cui_str': 'X-Linked Mental Retardation and Macroorchidism'}, {'cui': 'C0041432', 'cui_str': 'Twins, Identical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0079822', 'cui_str': 'Mentally Handicapped'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1527415', 'cui_str': 'Per oral route'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023741', 'cui_str': 'Linguistics'}]",,0.105736,"Although there was considerable variation in performance on these tests during the two baseline periods, there were no observable beneficial effects of therapy.","[{'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Rosenblatt', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Duschenes', 'Affiliation': ''}, {'ForeName': 'F V', 'Initials': 'FV', 'LastName': 'Hellstrom', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Golick', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Vekemans', 'Affiliation': ''}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Zeesman', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Andermann', 'Affiliation': ''}]",American journal of human genetics,[]
3020,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3021,32092309,Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis.,"BACKGROUND & AIMS


We evaluated the efficacy and safety of upadacitinib, an oral selective inhibitor of Janus kinase 1, as induction therapy for ulcerative colitis (UC).
METHODS


We performed a multicenter, double-blind, phase 2b study of 250 adults with moderately to severely active UC and an inadequate response, loss of response, or intolerance to corticosteroids, immunosuppressive agents, and/or biologic therapies. Patients were randomly assigned to groups that received placebo or induction therapy with upadacitinib (7.5 mg, 15 mg, 30 mg, or 45 mg, extended release), once daily for 8 weeks. The primary endpoint was the proportion of participants who achieve clinical remission according to the adapted Mayo score at week 8. No multiplicity adjustments were applied.
RESULTS


At week 8, 8.5%, 14.3%, 13.5%, and 19.6% of patients receiving 7.5 mg, 15 mg, 30 mg, or 45 mg upadacitinib, respectively, achieved clinical remission compared with none of the patients receiving placebo (P = .052, P = .013, P = .011, and P = .002 compared with placebo, respectively). Endoscopic improvement at week 8, defined as endoscopic subscore of ≤ 1, was achieved in 14.9%, 30.6%, 26.9%, and 35.7% of patients receiving upadacitinib 7.5 mg, 15 mg, 30 mg, or 45 mg, respectively, compared with 2.2% receiving placebo (P = .033, P < .001, P < .001, and P < .001 compared with placebo, respectively). One event of herpes zoster and 1 participant with pulmonary embolism and deep venous thrombosis (diagnosed 26 days after treatment discontinuation) were reported in the group that received upadacitinib 45 mg once daily. Increases in serum lipid levels and creatine phosphokinase with upadacitinib were observed.
CONCLUSION


In a phase 2b trial, 8 weeks of treatment with upadacitinib was more effective than placebo for inducing remission in patients with moderately to severely active UC. (ClinicalTrials.gov, Number: NCT02819635).",2020,One event of herpes zoster and 1 subject with pulmonary embolism and deep venous thrombosis (diagnosed 26 days after treatment discontinuation) were reported in the group that received upadacitinib 45 mg once daily.,"['patients with moderately to severely active UC', 'ulcerative colitis (UC', 'Patients With Active Ulcerative Colitis', '250 adults with moderately to severely active UC and an inadequate response, loss of response, or intolerance to corticosteroids, immunosuppressive agents, and/or biologic therapies']","['placebo', 'placebo or induction therapy with upadacitinib', 'Upadacitinib']","['endoscopic subscore', 'serum lipid levels and creatine phosphokinase with upadacitinib', 'proportion of subjects who achieve clinical remission according to the Adapted Mayo score', 'deep venous thrombosis', 'Endoscopic improvement', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1287373', 'cui_str': 'Finding of serum lipid levels (finding)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",250.0,0.463925,One event of herpes zoster and 1 subject with pulmonary embolism and deep venous thrombosis (diagnosed 26 days after treatment discontinuation) were reported in the group that received upadacitinib 45 mg once daily.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California. Electronic address: wsandborn@ucsd.edu.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre Birmingham, University of Birmingham and University Hospitals Birmingham National Health Service Trust, United Kingdom.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panes', 'Affiliation': 'Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanida', 'Affiliation': 'Nagoya City University, Nagoya, Japan.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Siffledeen', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Bidan', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Peter D R', 'Initials': 'PDR', 'LastName': 'Higgins', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan. Electronic address: phiggins@med.umich.edu.'}]",Gastroenterology,['10.1053/j.gastro.2020.02.030']
3022,3408224,Controlled therapeutic trial of IgA nephritis with follow-up renal biopsies.,"Forty-eight patients with IgA nephritis entered a 3 year controlled prospective trial using a combination regimen of cyclophosphamide for 6 months and dipyridamole and low dose warfarin for 36 months. Those in the treatment group (n = 27) had stable renal function and a significant decrease in proteinuria (p less than 0.01) but in the controlled group (n = 21) there was a significant fall in creatinine clearance (p less than 0.01) and rise in serum creatinine (p less than 0.02) with no change in proteinuria. The data suggested that the above treatment resulted in a significant reduction of proteinuria and more stable renal function. Eleven patients in the treatment group and 10 patients in the controlled group had repeat renal biopsies after the trial. Eight parameters were used in the evaluation of the renal biopsies: mesangial hypercellularity, crescents, tuft adhesion, segmental sclerosis, global sclerosis, tubular atrophy, interstitial fibrosis and vascular sclerosis. Each lesion was graded from 0 to 3 and a total scoring system used for evaluation of histological severity. In the treatment group there was no significant histological deterioration but in the controlled group there was progressive histological deterioration. Mean total histological score was 3.7 +/- 2.6 before the trial and 6.5 +/- 3.1 after the trial (p less than 0.05). This histological progression appeared to run parallel with the clinical course.",1988,In the treatment group there was no significant histological deterioration but in the controlled group there was progressive histological deterioration.,['Forty-eight patients with IgA nephritis'],"['dipyridamole and low dose warfarin', 'cyclophosphamide']","['rise in serum creatinine', 'renal biopsies: mesangial hypercellularity, crescents, tuft adhesion, segmental sclerosis, global sclerosis, tubular atrophy, interstitial fibrosis and vascular sclerosis', 'stable renal function', 'progressive histological deterioration', 'proteinuria and more stable renal function', 'Mean total histological score', 'repeat renal biopsies', 'histological deterioration', 'proteinuria', 'creatinine clearance']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0027697', 'cui_str': 'Nephritis'}]","[{'cui': 'C0012582', 'cui_str': 'Dipyridamole'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy (procedure)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0444628', 'cui_str': 'Crescents (qualifier value)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0334137', 'cui_str': 'Global sclerosis (morphologic abnormality)'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C3887486', 'cui_str': 'Interstitial fibrosis'}, {'cui': 'C0003850', 'cui_str': 'Arteriosclerosis'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}]",8.0,0.0155156,In the treatment group there was no significant histological deterioration but in the controlled group there was progressive histological deterioration.,"[{'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Woo', 'Affiliation': 'Department of Renal Medicine, Singapore General Hospital.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Chiang', 'Affiliation': ''}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Yap', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Lim', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3023,31370976,Effects of ascending buprenorphine doses on measures of experimental pain: A pilot study.,"BACKGROUND


Buprenorphine is widely used in the treatment of opioid use disorder and pain management. Little is known about the analgesic effects of high-dose sublingual buprenorphine, particularly in doses of >8 mg. The aim of this study was to examine the effect of ascending doses of buprenorphine upon acute pain measures in patients stabilized on buprenorphine as treatment for opioid dependence.
METHODS


The pilot study (n = 7) was a randomised, controlled, double-blind, double-dummy, within-subject crossover study examining cold-pressor threshold and tolerance testing under different buprenorphine dose conditions. Each participant attended three sessions to test the analgesic effect of buprenorphine in their usual dose (100%), 150% and 200% of their usual daily dose.
RESULTS


No significant effects of increased dose were seen on experimental pain measures. Expected physiological effects on pupil size and pulse were observed with increasing dose. No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition. No safety concerns with the 150 and 200% buprenorphine dose condition were observed.
DISCUSSION


This pilot study suggests that a ceiling effect on analgesia may be observed in people maintained on buprenorphine, though larger studies may confirm this finding. Clinical Trial Number: ACTRN12614001038684.",2019,"No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition.","['patients stabilized on', 'The pilot study (n\u202f=\u202f7']","['Buprenorphine', 'buprenorphine']","['experimental pain', 'subjective ratings of drug strength, or self-reported sedation', 'pupil size and pulse', 'experimental pain measures', ""lower ratings of 'bad effects' and intoxication"", 'acute pain measures', 'ratings drug liking']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]",,0.138001,"No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Monash Addiction Research Centre, Monash University, Melbourne, Australia; National Drug and Alcohol Research Centre, UNSW Sydney, Randwick, Australia; Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia. Electronic address: Suzanne.nielsen@monash.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demirkol', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia; University of Sydney, Division Addiction Medicine, Faculty of Medicine and Health, Sydney, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.002']
3024,31370128,Oral corticosteroids for painful acute otitis externa (swimmer's ear): A triple-blind randomised controlled trial.,"BACKGROUND AND OBJECTIVES


Acute otitis externa is often painful. The aim of this study was to evaluate the efficacy of 10 mg oral prednisolone twice daily for four days in addition to conventional therapy.
METHOD


Patients attending general practice clinics in Far North Queensland, Australia, for acute painful otitis externa were given a study capsule with either 10 mg prednisone or placebo.
RESULTS


Seventy-three patients were randomised. Results from 19 patients in the intervention group and 11 patients in the control group were analysed. Oral corticosteroids did not decrease the time to being completely pain-free but decreased the time for pain to reduce from more than 'moderate pain' to less than 'moderate pain', from 3.7 days to 2.4 days (P = 0.012, log rank test).
DISCUSSION


Oral corticosteroids seem to be effective in reducing more than 'moderate pain' to less than 'moderate pain'. However, this result needs to be confirmed in a larger trial.",2019,"Oral corticosteroids did not decrease the time to being completely pain-free but decreased the time for pain to reduce from more than 'moderate pain' to less than 'moderate pain', from 3.7 days to 2.4 days (P = 0.012, log rank test).
","[""painful acute otitis externa (swimmer's ear"", 'Patients attending general practice clinics in Far North Queensland, Australia, for acute painful otitis externa', 'Seventy-three patients were randomised']","['Oral corticosteroids', 'prednisone or placebo', 'prednisolone']","['time to being completely pain-free', 'time for pain']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0149948', 'cui_str': 'Acute otitis externa'}, {'cui': 'C0021355', 'cui_str': ""Swimmer's ear""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0029878', 'cui_str': 'External Otitis'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",73.0,0.426234,"Oral corticosteroids did not decrease the time to being completely pain-free but decreased the time for pain to reduce from more than 'moderate pain' to less than 'moderate pain', from 3.7 days to 2.4 days (P = 0.012, log rank test).
","[{'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Balch', 'Affiliation': 'MBChB, DipObst, FRACGP, General Practitioner, Toogood Road Family Medical Centre, Woree, Qld.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'Clare Heal MBChB, DRANZCOG, DipGUMed, FRACGP, MPHTM, PhD, Professor of General Practice, James Cook University, Qld.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Cervin', 'Affiliation': 'MD, PhD, Professor in Otorhinolaryngology at University of Queensland, Qld.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Gunnarsson', 'Affiliation': 'MD, PhD, Adjunct Professor, General Practice, Public Health and Community Medicine, Institute of Medicine, the Sahlgrenska Academy, University of Gothenburg, Sweden; Adjunct Professor, General Practice, Region Västra Götaland, Research and Development Primary Health Care, Research and Development Center Södra Älvsborg, Sweden; Adjunct Professor, General Practice, Centre for Antibiotic Resistance Research (CARe) at University of Gothenburg, Gothenburg, Sweden.'}]",Australian journal of general practice,['10.31128/AJGP-12-18-4795']
3025,31326778,"Public acceptability of nudging and taxing to reduce consumption of alcohol, tobacco, and food: A population-based survey experiment.","There is growing evidence for the effectiveness of choice architecture or 'nudge' interventions to change a range of behaviours including the consumption of alcohol, tobacco and food. Public acceptability is key to implementing these and other interventions. However, few studies have assessed public acceptability of these interventions, including the extent to which acceptability varies with the type of intervention, the target behaviour and with evidence of intervention effectiveness. These were assessed in an online study using a between-participants full factorial design with three factors: Policy (availability vs size vs labelling vs tax) x Behaviour (alcohol consumption vs tobacco use vs high-calorie snack food consumption) x Evidence communication (no message vs assertion of policy effectiveness vs assertion and quantification of policy effectiveness [e.g., a 10% change in behaviour]). Participants (N = 7058) were randomly allocated to one of the 36 groups. The primary outcome was acceptability of the policy. Acceptability differed across policy, behaviour and evidence communication (all ps < .001). Labelling was the most acceptable policy (supported by 78%) and Availability the least (47%). Tobacco use was the most acceptable behaviour to be targeted by policies (73%) compared with policies targeting Alcohol (55%) and Food (54%). Relative to the control group (60%), asserting evidence of effectiveness increased acceptability (63%); adding a quantification to this assertion did not significantly increase this further (65%). Public acceptability for nudges and taxes to improve population health varies with the behaviour targeted and the type of intervention but is generally favourable. Communicating that these policies are effective can increase support by a small but significant amount, suggesting that highlighting effectiveness could contribute to mobilising public demand for policies. While uncertainty remains about the strength of public support needed, this may help overcome political inertia and enable action on behaviours that damage population and planetary health.",2019,"There is growing evidence for the effectiveness of choice architecture or 'nudge' interventions to change a range of behaviours including the consumption of alcohol, tobacco and food.",['Participants (N\u202f=\u202f7058'],['Policy (availability vs size vs labelling vs tax) x Behaviour (alcohol consumption vs tobacco use vs high-calorie snack food consumption'],"['population health', 'policy, behaviour and evidence communication', 'Public acceptability', 'acceptability of the policy']",[],"[{'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0039371', 'cui_str': 'Taxes'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0453863', 'cui_str': 'Snack Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C3242284', 'cui_str': 'Population Health'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0869587,"There is growing evidence for the effectiveness of choice architecture or 'nudge' interventions to change a range of behaviours including the consumption of alcohol, tobacco and food.","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Reynolds', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Archer', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pilling', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kenny', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'University of Cambridge, UK. Electronic address: tm388@medschl.cam.ac.uk.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.112395']
3026,31522031,Effects of lung deflation induced by tiotropium/olodaterol on the cardiocirculatory responses to exertion in COPD.,"BACKGROUND


Hyperinflation has been associated with negative cardiocirculatory consequences in patients with chronic obstructive pulmonary disease (COPD). These abnormalities are likely to worsen when the demands for O 2  increase, e.g., under the stress of exercise. Thus, pharmacologically-induced lung deflation may improve cardiopulmonary interactions and exertional cardiac output leading to higher limb muscle blood flow and oxygenation in hyperinflated patients with COPD.
METHODS


20 patients (residual volume = 201.6 ± 63.6% predicted) performed endurance cardiopulmonary exercise tests (75% peak) 1 h after placebo or tiotropium/olodaterol 5/5 μg via the Respimat® inhaler (Boehringer Ingelheim, Ingelheim am Rhein, Germany). Cardiac output was assessed by signal-morphology impedance cardiography. Near-infrared spectroscopy determined quadriceps blood flow (indocyanine green dye) and intra-muscular oxygenation.
RESULTS


Tiotropium/olodaterol was associated with marked lung deflation (p < 0.01): residual volume decreased by at least 0.4 L in 14/20 patients (70%). The downward shift in the resting static lung volumes was associated with less exertional inspiratory constraints and dyspnoea thereby increasing exercise endurance by ~50%. Contrary to our premises, however, neither central and peripheral hemodynamics nor muscle oxygenation improved after active intervention compared to placebo. These results were consistent with those found in a subgroup of patients showing the largest decrements in residual volume (p < 0.05).
CONCLUSIONS


The beneficial effects of tiotropium/olodaterol on resting and operating lung volumes are not translated into enhanced cardiocirculatory responses to exertion in hyperinflated patients with COPD. Improvement in exercise tolerance after dual bronchodilation is unlikely to be mechanistically linked to higher muscle blood flow and/or O 2  delivery.",2019,"Contrary to our premises, however, neither central and peripheral hemodynamics nor muscle oxygenation improved after active intervention compared to placebo.","['COPD', '20 patients (residual volume\u202f=\u202f201.6\u202f±\u202f63.6% predicted) performed', 'hyperinflated patients with COPD', 'patients with chronic obstructive pulmonary disease (COPD']","['placebo', 'tiotropium/olodaterol', 'placebo or tiotropium', 'endurance cardiopulmonary exercise tests']","['marked lung deflation', 'central and peripheral hemodynamics nor muscle oxygenation', 'quadriceps blood flow (indocyanine green dye) and intra-muscular oxygenation', 'residual volume', 'muscle blood flow', 'Cardiac output']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0013343', 'cui_str': 'Dyes'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}]",,0.0352715,"Contrary to our premises, however, neither central and peripheral hemodynamics nor muscle oxygenation improved after active intervention compared to placebo.","[{'ForeName': 'Danilo C', 'Initials': 'DC', 'LastName': 'Berton', 'Affiliation': ""Respiratory Investigation Unit & Laboratory of Clinical Exercise Physiology, Queen's University & Kingston General Hospital, Kingston, ON, Canada; Programa de Pós-Graduação em Ciências Pneumológicas, Universidade Federal Do Rio Grande do Sul, Porto Alegre, Brazil.""}, {'ForeName': 'Renata D', 'Initials': 'RD', 'LastName': 'Marques', 'Affiliation': ""Respiratory Investigation Unit & Laboratory of Clinical Exercise Physiology, Queen's University & Kingston General Hospital, Kingston, ON, Canada; Programa de Pós-Graduação em Ciências Pneumológicas, Universidade Federal Do Rio Grande do Sul, Porto Alegre, Brazil.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Palmer', 'Affiliation': ""Respiratory Investigation Unit & Laboratory of Clinical Exercise Physiology, Queen's University & Kingston General Hospital, Kingston, ON, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Respiratory Investigation Unit & Laboratory of Clinical Exercise Physiology, Queen's University & Kingston General Hospital, Kingston, ON, Canada.""}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'Neder', 'Affiliation': ""Respiratory Investigation Unit & Laboratory of Clinical Exercise Physiology, Queen's University & Kingston General Hospital, Kingston, ON, Canada. Electronic address: alberto.neder@queensu.ca.""}]",Respiratory medicine,['10.1016/j.rmed.2019.09.006']
3027,32090492,Therapeutic use of pulsed electromagnetic field therapy reduces prostate volume and lower urinary tract symptoms in benign prostatic hyperplasia.,"BACKGROUND


Benign prostatic hyperplasia (BPH) etiology remains poorly understood, but chronic low-grade inflammation plays a role. Pulsed electromagnetic field therapy (PEMF) (1-50 Hz) is effective in reducing tissue inflammation.
OBJECTIVES


We designed a pilot study to evaluate the effects of PEMF on prostate volume (PV) in BPH.
MATERIALS AND METHODS


This is a prospective interventional trial on 27 naive patients with BPH and lower urinary tract symptoms (LUTS). At baseline (V 0  ), all patients had blood tests, transrectal ultrasound, and questionnaires (IPSS, IIEF-15) and received a perineal PEMF device (Magcell ®  Microcirc, Physiomed Elektromedizin). PEMF was delivered on perineal area 5 minutes twice daily for 28 days, then (V 1  ) all baseline evaluations were repeated. Afterward, nine patients continued therapy for 3 more months (PT group) and 15 discontinued (FU group). A 4-month evaluation (V 2  ) was performed in both groups.
RESULTS


A reduction was observed both at V 1  and at V 2  in PV: PV V0  44.5 mL (38.0;61.6) vs PV V1  42.1 mL (33.7;61.5, P = .039) vs PV V2  41.7mL (32.7;62.8, P = .045). IPSS was reduced both at V 1  and at V 2  : IPSS V0  11 (5.7;23.2) vs IPSS V1  10 (6;16, P = .045) vs IPSS V2  9 (6;14, P = .015). Baseline IPSS was related to IPSS reduction both at V 1  (r s   = 0.313;P = .003) and at V 2  (r s   = 0.664;P < .001). PV reduction in patients without metabolic syndrome (ΔPV V1nMetS  -4.7 mL, 95%CI -7.3;-2.0) was greater than in affected patients (ΔPV V1MetS  1.7 mL, 95%CI -2.69;6.1)(P = .017, Relative Risk MetS   = 6). No changes were found in gonadal hormones or sexual function.
DISCUSSION


PEMF was able to reduce PV after 28 days of therapy. Symptoms improved in a short time, with high compliance and no effects on hormonal and sexual function or any side effects. Patients with moderate-severe LUTS and without MetS seem to benefit more from this treatment.
CONCLUSION


PEMF reduces PV and improves LUTS in a relative short time, in BPH patients. These benefits seem greater in those patients with moderate-severe LUTS but without MetS.",2020,"PV reduction in patients without metabolic syndrome (ΔPV V1nMetS  -4.7 mL,95%CI -7.3;-2.0) was greater than in affected patients (ΔPV V1MetS  1.7 mL,95%CI -2.69;6.1)(p=0.017,Relative Risk MetS  =6).","['Benign Prostatic Hyperplasia', '27 naïve patients with BPH and lower urinary tract symptoms (LUTS']","['perineal PEMF device (Magcell ®  Microcirc, Physiomed Elektromedizin', 'Pulsed Electro Magnetic Field therapy (PEMF) (1-50Hz', 'Pulsed Electromagnetic Field Therapy', 'PEMF']","['blood tests, trans-rectal ultrasound, questionnaires (IPSS, IIEF', 'gonadal hormones or sexual function', 'IPSS', 'Prostate Volume and Lower Urinary Tract Symptoms', 'hormonal and sexual function, high compliance and without side-effects', 'PV reduction']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3852954', 'cui_str': 'Physiome'}, {'cui': 'C2350609', 'cui_str': 'Magnetic Stimulation Therapy'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C1112240', 'cui_str': 'Rectal ultrasound'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301819', 'cui_str': 'Gonadal Hormones'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",27.0,0.0399597,"PV reduction in patients without metabolic syndrome (ΔPV V1nMetS  -4.7 mL,95%CI -7.3;-2.0) was greater than in affected patients (ΔPV V1MetS  1.7 mL,95%CI -2.69;6.1)(p=0.017,Relative Risk MetS  =6).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Tenuta', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Tarsitano', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mazzotta', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Lucchini', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Sesti', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Fattorini', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Pozza', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Olivieri', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic and Orthopedic Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Gianfrilli', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lenzi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pofi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}]",Andrology,['10.1111/andr.12775']
3028,32040868,Protective effects of doxepin cream on radiation dermatitis in breast cancer: A single arm double-blind randomized clinical trial.,"AIMS


Breast cancer is the most frequently occurring cancer in women. Lumpectomy followed by radiotherapy is suggested to be as effective as a total mastectomy. Radiation-induced dermatitis often occurs as a result of breast radiotherapy. Recent studies suggest that doxepin has promising anti-inflammatory properties. This study was undertaken to evaluate the effects of doxepin therapy on radiation dermatitis.
METHODS


A double-blind randomized clinical trial was launched from 2016 to 2017, with a total of 48 patients who had undergone breast-conserving surgery and received postoperative radiation therapy. Radiotherapy was applied 5 days per week for 5 weeks. Adverse dermatological effects were evaluated by a physician at the beginning of the fifth week of radiotherapy and the patients were then randomly assigned (1:1 ratio) to receive either doxepin (5%) or placebo cream for 7 days.
RESULTS


There were no significant differences in the dermatitis grade between doxepin and placebo groups at baseline (P > .5). The occurrence of acute dermatitis (grade 2 or higher) was significantly lower with the use of doxepin than with placebo (P ≤ .0001, Z α  = 1.96 at 95% confidence interval).
CONCLUSION


Doxepin cream prevents dermatitis grade 2 or higher during post-operative breast irradiation. Doxepin cream is easy to use, affordable and prevents pain and irritation.",2020,"The occurrence of acute dermatitis (grade 2 or higher) was significantly lower with the use of doxepin than with placebo (P=<0.0001, Z α  = 1.96 at 95% confidence interval).
","['2016 to 2017, with a total of 48 patients who had undergone breast-conserving surgery and received', 'women', 'breast cancer']","['doxepin', 'Radiotherapy', 'placebo cream', 'doxepin therapy', 'Doxepin cream', 'doxepin cream', 'post-operative radiation therapy', 'Lumpectomy followed by radiotherapy', 'placebo', 'radiotherapy']","['radiation dermatitis', 'Adverse dermatological effects', 'dermatitis grade', 'occurrence of acute dermatitis']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0013085', 'cui_str': 'Doxepin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0262972', 'cui_str': 'Acute dermatitis (disorder)'}]",48.0,0.500973,"The occurrence of acute dermatitis (grade 2 or higher) was significantly lower with the use of doxepin than with placebo (P=<0.0001, Z α  = 1.96 at 95% confidence interval).
","[{'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Shariati', 'Affiliation': 'Applied Physiology Research Center, Cardiovascular Research Institute, Department of Physiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Amouheidari', 'Affiliation': 'Department of Radiation Oncology, Milad Hospital, Isfahan, Iran.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Naji Esfahani', 'Affiliation': 'Applied Physiology Research Center, Cardiovascular Research Institute, Department of Physiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abed', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Haghjooy Javanmard', 'Affiliation': 'Applied Physiology Research Center, Cardiovascular Research Institute, Department of Physiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Laher', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Applied Physiology Research Center, Cardiovascular Research Institute, Department of Physiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Vaseghi', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",British journal of clinical pharmacology,['10.1111/bcp.14238']
3029,3435009,Screening for colorectal cancer--the Nottingham experience.,"The advanced stage of most colorectal cancers at the time of presentation is largely responsible for the poor prognosis of the majority of patients with this tumour. Symptoms attributable to colorectal cancer are nonspecific and there is often considerable delay between their onset and diagnosis. By offering faecal occult blood (FOB) tests to patients presenting to their family doctors with abdominal symptoms the delay in diagnosis was significantly reduced but the pathological stage of the cancers was similar to that of a control group managed by their family doctors in their standard manner. In order to detect cancers at an earlier, asymptomatic stage a randomised control trial of FOB testing was instituted. A total of 26,975 individuals from the general population between the ages of 45 and 75 years were randomised to receive FOB tests or to be controls. 4,917 (36%) completed the tests and a total of 18 cancers were detected of which 13 (72%) were confined to the bowel wall. At rescreen a further six cancers (3 stage A) were detected by FOB tests. In the control group 20 cancers were diagnosed at two years of which only one (5%) was stage A. Asymptomatic screening showed a significant increase in the proportion of early stage tumours but the effect on mortality will await long term follow up.",1987,"A total of 26,975 individuals from the general population between the ages of 45 and 75 years were randomised to receive FOB tests or to be controls.","['26,975 individuals from the general population between the ages of 45 and 75 years']",['FOB tests'],"['proportion of early stage tumours', 'faecal occult blood (FOB) tests']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",26975.0,0.0690023,"A total of 26,975 individuals from the general population between the ages of 45 and 75 years were randomised to receive FOB tests or to be controls.","[{'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Armitage', 'Affiliation': 'Department of Surgery, University Hospital, Nottingham, United Kingdom.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Hardcastle', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3030,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND


Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS


We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10  viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS


Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION


Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING


Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3031,31121294,Effect of cane use on bone marrow lesion volume in people with medial tibiofemoral knee osteoarthritis: randomized clinical trial.,"OBJECTIVE


To evaluate effects of daily cane use for 3 months on medial tibiofemoral bone marrow lesion (BML) volumes in people with medial tibiofemoral osteoarthritis (OA).
DESIGN


In this randomized controlled trial (RCT), 79 participants with medial tibiofemoral OA were randomized to either a cane group (using a cane whenever walking) or control group (not using any gait aid) for 3 months. The cane group received a single training session by a physiotherapist, using a biofeedback cane to teach optimal technique and body weight support and motor learning principles to facilitate retention of learning. The primary outcome was change in total medial tibiofemoral BML volume (per unit bone volume) measured from magnetic resonance imaging (MRI) at 3 months. Secondary outcomes were BML volumes (per unit bone volume) of the medial tibia and femur, and patient-reported outcomes of overall knee pain, knee pain on walking, physical function, perceived global symptom changes and health-related quality of life. MRI analyses were performed by a blinded assessor.
RESULTS


Seventy-eight participants (99%) completed the primary outcome. Mean (standard deviation) daily cane use was 2.3 (1.7) hours over 3 months. No evidence of between-group differences was found for change in total medial tibiofemoral BML volume (mean difference: -0.0010 (95% confidence intervals: -0.0022, 0.0003)). Most secondary outcomes showed minimal differences between groups.
CONCLUSION


Daily use of a cane during walking for 3 months aiming to reduce knee joint loading did not change medial tibiofemoral BML volumes compared to no use of gait aids.
CLINICAL TRIAL REGISTRATION


Australian New Zealand Clinical Trial Registry (ACTRN12614000909628).",2019,"Daily use of a cane during walking for 3 months aiming to reduce knee joint loading did not change medial tibiofemoral BML volumes compared to no use of gait aids.
","['79 participants with medial tibiofemoral OA', 'people with medial tibiofemoral knee osteoarthritis', 'people with medial tibiofemoral osteoarthritis (OA']","['single training session by a physiotherapist, using a biofeedback cane to teach optimal technique and body weight support and motor learning principles', 'cane group (using a cane whenever walking) or control group (not using any gait aid', 'daily cane', 'cane use']","['bone marrow lesion volume', 'medial tibiofemoral bone marrow lesion (BML) volumes', 'BML volumes (per unit bone volume) of the medial tibia and femur, and patient-reported outcomes of overall knee pain, knee pain on walking, physical function, perceived global symptom changes and health-related quality of life', 'Mean (standard deviation) daily cane use', 'total medial tibiofemoral BML volume', 'total medial tibiofemoral BML volume (per unit bone volume']","[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0006856', 'cui_str': 'Walking Sticks'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006856', 'cui_str': 'Walking Sticks'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",79.0,0.207564,"Daily use of a cane during walking for 3 months aiming to reduce knee joint loading did not change medial tibiofemoral BML volumes compared to no use of gait aids.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Van Ginckel', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium; Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Parkville, Australia. Electronic address: Ans.VanGinckel@UGent.be.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Parkville, Australia. Electronic address: ranash@unimelb.edu.au.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Parkville, Australia. Electronic address: timw@unimelb.edu.au.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Parkville, Australia. Electronic address: david.hunter@sydney.edu.au.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Marshall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Parkville, Australia. Electronic address: c.marshall@unimelb.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duryea', 'Affiliation': ""Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, USA. Electronic address: jduryea@bwh.harvard.edu.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Melo', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, Sydney, Australia; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia. Electronic address: luciano.melo@sydney.edu.au.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Simic', 'Affiliation': 'Discipline of Physiotherapy, Musculoskeletal Research Group, Faculty of Health Sciences, The University of Sydney, Sydney, Australia. Electronic address: milena.simic@sydney.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia. Electronic address: jessica.kasza@monash.edu.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Robbins', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, Sydney, Australia; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia. Electronic address: sarah.robbins@sydney.edu.au.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wallis', 'Affiliation': 'Department of Physical Therapy, Eastern Health. Department of Physical Therapy, La Trobe University, Melbourne, Australia. Electronic address: Jason.wallis@easternhealth.org.au.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Parkville, Australia. Electronic address: k.bennell@unimelb.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.05.004']
3032,32077737,"Randomized controlled trial study of the effects of an online divorce platform on anxiety, depression, and somatization.","Divorce is associated with a range of negative psychological consequences, including increased symptoms of anxiety, depression, and somatization. The current study presents the results of a 1-year longitudinal randomized controlled trial study of the Cooperation After Divorce online intervention platform for adults going through a divorce. Participants included 1,856 Danish divorcees who, on average, began the intervention within 1 week of legal divorce and responded to the Symptom Checklist-90-Revised anxiety, depression, and somatization subscales at baseline, 3, 6, and 12 months after juridical divorce. Data analyses consisted of linear mixed-effect model analyses, mean group comparisons, and 1-sample t tests to compare the 12-month follow-up with national normative data. The study found that the intervention platform significantly reduced anxious, depressive, and somatization symptoms among divorcees in the intervention group over a 1-year period and that the magnitude of these effects was large in effect size (Cohen's  d  > .78). Further, it was found that at 1 year after divorce, symptom levels of all 3 outcomes were close to the population norms for participants in the intervention group but still considerably elevated for participants in the control group. The findings suggest that online intervention platforms may be effective in reducing adverse mental health related effects of divorce and thereby offer long-term human and public health benefits. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The study found that the intervention platform significantly reduced anxious, depressive, and somatization symptoms among divorcees in the intervention group over a 1-year period and that the magnitude of these effects was large in effect size (Cohen's  d  > .78).","['Participants included 1,856 Danish divorcees who, on average, began the intervention within 1 week of legal divorce and responded to the Symptom Checklist-90-Revised anxiety, depression, and somatization subscales at baseline, 3, 6, and 12 months after juridical divorce', 'adults going through a divorce']","['Cooperation', 'online divorce platform']","['symptom levels', 'symptoms of anxiety, depression, and somatization', 'anxiety, depression, and somatization', 'anxious, depressive, and somatization symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0086170', 'cui_str': 'Divorced'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0702661,"The study found that the intervention platform significantly reduced anxious, depressive, and somatization symptoms among divorcees in the intervention group over a 1-year period and that the magnitude of these effects was large in effect size (Cohen's  d  > .78).","[{'ForeName': 'Gert Martin', 'Initials': 'GM', 'LastName': 'Hald', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ciprić', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Camilla Stine', 'Initials': 'CS', 'LastName': 'Øverup', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Štulhofer', 'Affiliation': 'Department of Sociology, Faculty of Humanities and Social Sciences, University of Zagreb.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Sander', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gad Kjeld', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Jenna Marie', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000635']
3033,31434037,Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics.,"BACKGROUND


Inhaled corticosteroids (ICS) decrease airway inflammation and airway hyperresponsiveness (AHR). Previous studies have generally investigated the effect of ICS on methacholine-induced AHR following weeks or months of medium to high dose treatment.
PURPOSE


The short-term effects of once-daily fluticasone furoate (FF) 100 mcg on methacholine-induced AHR and airway inflammation were examined over the course of one week.
METHODS


Eleven mild asthmatics completed this randomized, double-blind crossover study. Once-daily FF (100 mcg) and identical appearing placebo Ellipta® inhalers were given for 7 days with a 2-week washout. Methacholine challenges were performed before and 24 h after the first, third and seventh doses. Fractional exhaled nitric oxide (FeNO) was measured initially and at 7 days.
RESULTS


FF significantly (p = 0.0009-0.0078) increased methacholine PD 20  (provocative dose causing 20% fall in forced expiratory volume in 1 s) at all times. Doubling dose shifts (95% CI) were 1.23 (0.60-1.86), 1.17 (0.68-1.67) and 1.44 (0.93-1.94) after the first, third and seventh dose respectively. FeNO (geometric mean, 95% CI) decreased significantly (p = 0.0049) following FF treatment from 37.9 ppb (23.7-60.5) initially to 22.9 ppb (14.8-35.5) at 7 days. Placebo did not affect methacholine PD 20  or FeNO.
CONCLUSION


Single-dose FF 100 mcg decreased methacholine AHR at 24 h without significant further improvement with continued daily use over 7 days. The inhibition in AHR after one week of daily dosing coincided with a significant decrease in FeNO at 7 days. Contrary to past assumptions, the ICS FF appears to rapidly reduce AHR to methacholine.",2019,"FeNO (geometric mean, 95% CI) decreased significantly (p = 0.0049) following FF treatment from 37.9 ppb (23.7-60.5) initially to 22.9 ppb (14.8-35.5) at 7 days.","['mild asthmatics', 'Eleven mild asthmatics']","['fluticasone furoate (FF', 'Inhaled corticosteroids (ICS', 'Placebo', 'fluticasone furoate', 'placebo Ellipta® inhalers']","['methacholine PD 20  or FeNO', 'inhibition in AHR', 'FeNO', 'methacholine AHR', 'Fractional exhaled nitric oxide (FeNO', 'AHR and airway inflammation', 'airway inflammation and airway hyperresponsiveness (AHR']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0429911', 'cui_str': 'PD 20 (finding)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.330149,"FeNO (geometric mean, 95% CI) decreased significantly (p = 0.0049) following FF treatment from 37.9 ppb (23.7-60.5) initially to 22.9 ppb (14.8-35.5) at 7 days.","[{'ForeName': 'Chiamaka S', 'Initials': 'CS', 'LastName': 'Okonkwo', 'Affiliation': 'University of Saskatchewan, College of Medicine, Department of Anatomy, Physiology and Pharmacology, 107 Wiggins Road, Saskatoon, SK, S7N 5E5, Canada.'}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Davis', 'Affiliation': 'University of Saskatchewan, College of Medicine, Department of Anatomy, Physiology and Pharmacology, 107 Wiggins Road, Saskatoon, SK, S7N 5E5, Canada; University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine, 103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Christianne M', 'Initials': 'CM', 'LastName': 'Blais', 'Affiliation': 'University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine, 103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Cockcroft', 'Affiliation': 'University of Saskatchewan, College of Medicine, Department of Anatomy, Physiology and Pharmacology, 107 Wiggins Road, Saskatoon, SK, S7N 5E5, Canada; University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine, 103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada. Electronic address: don.cockcroft@usask.ca.'}]",Respiratory medicine,['10.1016/j.rmed.2019.08.007']
3034,32073415,'Stop sign' position for subclavian ultrasound: a single-blinded observational study of subclavian vein dimensions.,"OBJECTIVE


Right subclavian vein (SCV) dimensions were evaluated on ultrasound and whether these change when the right upper limb is in a neutral position compared with the 'stop sign' position (shoulder abducted and externally rotated to 90°, elbow flexed to 90°), and when patients were positioned 30° head-up compared with lying supine.
METHODS


Images of transverse and longitudinal views of the right SCV in patients ≥18 years, presenting with a range of conditions to a Regional Hospital Emergency Department, were recorded by two physicians in a randomly assigned, nonsequential order and measured blinded. Data were analysed with paired Student's t tests. N = 62.
RESULTS


Primary outcome: cross-sectional area (CSA) of the right SCV in transverse images.
SECONDARY OUTCOMES


depth of SCV to skin and diameter of SCV on longitudinal images. There was no significant difference in CSA of the SCV in supine patients when the arm was in the stop sign position compared with neutral (mean CSA: 1.20 ± 0.42 and 1.15 ± 0.39 cm, respectively; P = 0.3). In patients positioned 30° head-up, the stop sign position significantly increased CSA from 0.65 ± 0.33 to 1.00 ± 0.38 cm (P < 0.0001).
CONCLUSIONS


Utilizing the stop sign position does not change SVC dimensions when patients are supine, however, may improve dimensions when lying supine is contraindicated.",2020,"There was no significant difference in CSA of the SCV in supine patients when the arm was in the stop sign position compared with neutral (mean CSA: 1.20 ± 0.42 and 1.15 ± 0.39 cm, respectively; P = 0.3).","['patients ≥18\u2009years, presenting with a range of conditions to a Regional Hospital Emergency Department, were recorded by two physicians in a randomly assigned, nonsequential order and measured blinded']","['right SCV', 'subclavian ultrasound']","['sectional area (CSA) of the right SCV in transverse images', 'depth of SCV to skin and diameter of SCV on longitudinal images', 'CSA of the SCV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0589488', 'cui_str': 'Subclavicular approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}]",,0.0507039,"There was no significant difference in CSA of the SCV in supine patients when the arm was in the stop sign position compared with neutral (mean CSA: 1.20 ± 0.42 and 1.15 ± 0.39 cm, respectively; P = 0.3).","[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Lister', 'Affiliation': 'Departments of Intensive Care.'}, {'ForeName': ""Oliver W d'A"", 'Initials': 'OWD', 'LastName': 'Welfare', 'Affiliation': 'Emergency, Hawkes Bay Hospital, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cheri', 'Affiliation': 'Emergency, Hawkes Bay Hospital, New Zealand.'}, {'ForeName': 'Michael A J', 'Initials': 'MAJ', 'LastName': 'Park', 'Affiliation': 'Departments of Intensive Care.'}]",European journal of emergency medicine : official journal of the European Society for Emergency Medicine,['10.1097/MEJ.0000000000000676']
3035,31371154,Haemostasis in oral surgical procedures involving patients with a ventricular assist device.,"The purpose of this study was to determine whether tooth extraction for patients with ventricular assist devices (VADs) could be performed without interruption of anticoagulant and/or antiplatelet therapy and whether treatment with von Willebrand factor concentrates and desmopressin is required. The study consisted of three groups of patients undergoing oral surgery. The two experimental groups comprised patients with VADs, while the third group included cardiovascular patients without VADs who served as controls. All patients were treated intraoperatively with topical haemostatic agents (oxidized cellulose or collagen). The first group was additionally treated with fibrin glue. All 75 oral surgical procedures were performed under local anaesthesia without sedation. Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups. The findings suggest that dental extraction can be performed without modification of oral anticoagulation or antiplatelet treatments, providing that INR is less than 3.5 on the day of the operation. It can further be hypothesized that an acquired coagulopathy in VAD patients does not influence the bleeding risk in dental extractions, and so the administration of desmopressin and/or von Willebrand factor concentrates is not required.",2019,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","['patients with VADs, while the third group included cardiovascular patients without VADs who served as controls', 'patients undergoing oral surgery', 'patients with ventricular assist devices (VADs', 'patients with a ventricular assist device']","['local anaesthesia without sedation', 'topical haemostatic agents (oxidized cellulose or collagen', 'fibrin glue']","['incidence of haemorrhage', 'haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0007649', 'cui_str': 'Absorbable Cellulose'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0222906,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Hamzah', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany. Electronic address: hamzah@medizin.uni-leipzig.de.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Graf', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Kaluđerović', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany; Practice for Maxillofacial Surgery, Lepsiusstraße 2, 06618 Naumburg, Germany.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Meyer', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Dieterlen', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hemprich', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.07.009']
3036,31524075,Prednisolone Pretreatment Enhances Intermittent Hypoxia-Induced Plasticity in Persons With Chronic Incomplete Spinal Cord Injury.,"Objective . To test the hypothesis that an anti-inflammatory corticosteroid drug enhances spinal motor plasticity induced by acute intermittent hypoxia (AIH) in persons with chronic incomplete spinal cord injury (iSCI).  Methods . Fourteen subjects with incomplete spinal cord injury (ASIA level C or D; mean age = 46 years) participated in a randomized, double-blinded, crossover, and placebo-controlled study. Subjects received either 60 mg oral prednisolone or a matching placebo, 1 hour before administration of AIH (15, 60-second hypoxic exposures; fraction of inspired oxygen [F i O 2 ] = 0.09). Changes in voluntary ankle strength, lower extremity electromyograms (EMG), and serum inflammatory biomarkers were quantified.  Results . Maximal ankle plantarflexion torque was significantly higher following prednisolone + AIH versus placebo + AIH (mean difference [MD] 9, 11, and 7 newton meter [N∙m] at 30, 60, and 120 minutes post-AIH, respectively; all  P s <.02). Soleus surface EMG during maximal voluntary contraction was also significantly increased following prednisolone + AIH (MD 3.5,  P  = .02 vs placebo + AIH), while activity of other leg muscles remained unchanged. Individuals had significantly higher levels of the anti-inflammatory serum biomarker interleukin-10 after prednisolone versus placebo ( P  = .004 vs placebo + AIH).  Conclusions . Pretreatment with prednisolone increased the capacity for AIH-induced functional motor plasticity, suggesting that suppression of inflammation enhances the efficacy of AIH administration in individuals with spinal cord injury. Clinical trial registration number: NCT03752749.",2019,"Maximal ankle plantarflexion torque was significantly higher following prednisolone + AIH versus placebo + AIH (mean difference [MD] 9, 11, and 7 newton meter [N∙m] at 30, 60, and 120 minutes post-AIH, respectively; all  P s <.02).","['persons with chronic incomplete spinal cord injury (iSCI', 'Persons With Chronic Incomplete Spinal Cord Injury', 'Fourteen subjects with incomplete spinal cord injury (ASIA level C or D; mean age = 46 years', 'individuals with spinal cord injury']","['prednisolone', 'prednisolone + AIH versus placebo + AIH', '60 mg oral prednisolone or a matching placebo', 'placebo + AIH', 'placebo', 'Prednisolone']","['Maximal ankle plantarflexion torque', 'anti-inflammatory serum biomarker interleukin-10', 'voluntary ankle strength, lower extremity electromyograms (EMG), and serum inflammatory biomarkers', 'Soleus surface EMG during maximal voluntary contraction']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0021589', 'cui_str': 'AIH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}]",14.0,0.561412,"Maximal ankle plantarflexion torque was significantly higher following prednisolone + AIH versus placebo + AIH (mean difference [MD] 9, 11, and 7 newton meter [N∙m] at 30, 60, and 120 minutes post-AIH, respectively; all  P s <.02).","[{'ForeName': 'Milap S', 'Initials': 'MS', 'LastName': 'Sandhu', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Jayaraman', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'Gordon S', 'Initials': 'GS', 'LastName': 'Mitchell', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Rymer', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, IL, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968319872992']
3037,31372757,"Transdermal estradiol for postpartum depression: results from a pilot randomized, double-blind, placebo-controlled study.","Postpartum depression (PPD) is a common complication following delivery, though evidence-based treatment options are limited. This study explores the feasibility and efficacy of outpatient PPD treatment with transdermal estradiol (TE). In a pilot, double-blind, placebo-controlled trial, women with PPD were randomized to receive transdermal 17β-estradiol (100 mcg/day) or placebo patch. Over 6 weeks, women completed weekly ratings on the Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D). Primary outcome measures were treatment response (> 50% decrease from baseline BDI) and remission (BDI < 10) at 6 weeks, and secondary outcome measures included severity on all scales at weeks 3 and 6. Of 12 recruited women, 6 received TE and 6 received placebo. By week 6, 5 women receiving TE responded to treatment and 4 showed symptom remission, compared to 2 responders and 1 remitter in the placebo group. This difference was not significant (p = 0.24). In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction. Analogous effects were found for HAM-D but not EPDS scores. Interestingly, no significant difference in plasma estradiol levels existed between groups. We were unable to demonstrate a significant therapeutic benefit of TE compared with placebo in PPD. Although limited by under-recruitment and loss to follow-up, our results suggest TE is a feasible option for outpatient PPD management, with preliminary evidence (based on secondary outcomes) for efficacy. Therapeutic effects may be seen as early as 3 weeks and may not directly depend on peripheral measures of estradiol.",2020,"In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction.","['Of 12 recruited women, 6 received TE and 6 received', 'postpartum depression', 'women with PPD']","['Transdermal estradiol', 'placebo', 'placebo patch', 'transdermal 17β-estradiol', 'outpatient PPD treatment with transdermal estradiol (TE']","['plasma estradiol levels', 'Postpartum depression (PPD', 'symptom remission', 'treatment response (>\u200950% decrease from baseline BDI) and remission', 'Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1277973', 'cui_str': 'Plasma estradiol measurement'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}]",12.0,0.768545,"In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction.","[{'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Martinez', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Epidemiology, National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Schenkel', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lynnette K', 'Initials': 'LK', 'LastName': 'Nieman', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Schmidt', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. PeterSchmidt@mail.nih.gov.'}]",Archives of women's mental health,['10.1007/s00737-019-00991-3']
3038,31109481,Comparison of 2 regimens of loteprednol etabonate and bromfenac for cataract surgery.,"OBJECTIVE


We aimed to evaluate the safety and effectiveness of 2 dosing regimens of loteprednol etabonate (LE) ophthalmic gel 0.5% and bromfenac ophthalmic solution 0.07% in patients undergoing routine cataract surgery.
DESIGN


Six-week prospective, masked, randomized controlled noninferiority study.
PARTICIPANTS


One hundred eyes.
METHODS


Patients undergoing uncomplicated cataract surgery were selected in a consecutive manner. Patients were randomized to one of 2 groups: LE QID + qD bromfenac (control group) versus LE BID + qD bromfenac (study group). Primary outcome metrics included summed ocular inflammation score (SOIS) and adverse events. Secondary outcome measures included intraocular pressure, visual acuity, central retinal thickness, and subjective symptomology scores measured at 4 study visits. The final visit included a questionnaire addressing compliance, satisfaction, and comfort with the medications.
RESULTS


Both groups demonstrated similar effectiveness and safety between dosing regimens. No statistically significant difference was reported between groups regarding SOIS (visit 1 p = N/A, visit 2 p = 0.66, visit 3 p = 0.60, visit 4 p = 0.08). No adverse events were reported relating to the difference in study regimen. A statistically significant difference was not found regarding secondary outcomes (p > 0.05). Control group patients reported a more difficult time remembering their doses for bromfenac but not LE (bromfenac p < 0.05; LE p = 0.15).
CONCLUSIONS


Our data suggest that both groups had similar outcomes with respect to control of ocular inflammation with no differences in adverse outcomes. The compliance questionnaire also suggests a patient preference for the dosing regimen with lower frequency of drop application.",2019,"No statistically significant difference was reported between groups regarding SOIS (visit 1 p = N/A, visit 2 p = 0.66, visit 3 p = 0.60, visit 4 p = 0.08).","['One hundred eyes', 'cataract surgery', 'Patients undergoing uncomplicated cataract surgery', 'patients undergoing routine cataract surgery']","['loteprednol etabonate (LE) ophthalmic gel', 'loteprednol etabonate', 'LE QID\u202f+\u202fqD bromfenac (control group) versus LE BID\u202f+\u202fqD bromfenac']","['intraocular pressure, visual acuity, central retinal thickness, and subjective symptomology scores', 'questionnaire addressing compliance, satisfaction, and comfort with the medications', 'summed ocular inflammation score (SOIS) and adverse events', 'adverse events', 'effectiveness and safety', 'difficult time remembering their doses for bromfenac but not LE', 'safety and effectiveness']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C3499690', 'cui_str': 'loteprednol etabonate Ophthalmic Gel [Lotemax]'}, {'cui': 'C0126177', 'cui_str': 'loteprednol etabonate'}, {'cui': 'C0054094', 'cui_str': 'bromfenac'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]",100.0,0.0837184,"No statistically significant difference was reported between groups regarding SOIS (visit 1 p = N/A, visit 2 p = 0.66, visit 3 p = 0.60, visit 4 p = 0.08).","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Awadi', 'Affiliation': 'Wayne State University School of Medicine, Detroit, MI.'}, {'ForeName': 'Hassan A', 'Initials': 'HA', 'LastName': 'Tokko', 'Affiliation': 'Wayne State University School of Medicine, Detroit, MI.'}, {'ForeName': 'Clara C', 'Initials': 'CC', 'LastName': 'Chan', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Sohel', 'Initials': 'S', 'LastName': 'Somani', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont.; William Osler Health Systems, Brampton, Ont.; Uptown Eye Specialists, Brampton, Ont.. Electronic address: s.somani@utoronto.ca.'}]",Canadian journal of ophthalmology. Journal canadien d'ophtalmologie,['10.1016/j.jcjo.2018.07.007']
3039,31548616,Effect of self-initiated and fully-automated self-measurement on blood pressure.,"Self-measurement of blood pressure (BP) is regularly used to diagnose hypertension and to monitor BP at home. We recently showed that self-measurement of BP may elicit a pressor or 'auto-cuff' response. In this study we examined whether the pressor response is different between self-initiated and fully-automated BP measurement. We performed two randomized crossover studies in outpatients visiting a hypertension clinic. The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography. The second cohort consisted of 120 patients who performed three self-initiated and three fully-automated BP measurements. In the first cohort (mean age 61.2 ± 10.4 years, mean office BP 142.0 ± 19.9/82.5 ± 12.2 mmHg, 36.7% female) average systolic and diastolic BP increased by 7.3 ± 8.5/3.3 ± 4.0 mmHg in the group with self-initiated BP measurements, while BP increased by 3.3 ± 6.3/1.4 ± 3.0 mmHg during fully-automated measurements (p = 0.002/p = 0.002 for difference between groups). The higher BP increase during self-initiated BP measurements resulted from an increase in heart rate and cardiac output. In the second cohort (mean age 58.0 ± 14.1 years, mean office BP 153.6 ± 23.8/86.3 ± 14.0 mmHg, 44.1% female) self-initiated BP measurement resulted in a 2.1 ± 6.8/0.9 ± 4.0 mmHg higher systolic and diastolic BP compared with fully-automated self-measurement (p = 0.001/0.018). In conclusion, our findings suggest that self-initiated BP measurement using a fully-automated method results in a more reliable BP compared with a self-initiated semi-automated method by attenuating the auto-cuff response. These findings may have implications for the self-measurement of BP.",2020,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","['outpatients visiting a hypertension clinic', '120 patients who performed three self-initiated and three fully-automated BP measurements', 'In the second cohort (mean age 58.0\u2009±\u200914.1 years, mean office BP 153.6\u2009±\u200923.8/86.3\u2009±\u200914.0\u2009mmHg, 44.1% female']",['self-initiated and fully-automated self-measurement'],"['blood pressure', 'systolic and diastolic BP', 'heart rate and cardiac output', 'pressor response', 'self-initiated BP measurement', 'Self-measurement of blood pressure (BP']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",52.0,0.024403,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","[{'ForeName': 'Rosanne T', 'Initials': 'RT', 'LastName': 'Berkhof', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gazzola', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands. b.j.vandenborn@amsterdamumc.nl.'}]",Journal of human hypertension,['10.1038/s41371-019-0256-1']
3040,31654294,Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials.,"BACKGROUND


Endometriosis profoundly impairs women's workplace and household productivity.
OBJECTIVE


The aim of this study was to evaluate the impact of elagolix on endometriosis-related workplace and household productivity losses.
METHODS


Data were pooled from two phase III trials of women aged 18-49 years with moderate to severe endometriosis-associated pain treated for 6 months with elagolix 150 mg daily (QD), 200 mg twice daily (BID), or placebo. The Health-Related Productivity Questionnaire was administered at baseline, Month 3, and Month 6 to determine workplace and household absenteeism and presenteeism. Productivity changes from baseline were compared between placebo and elagolix doses via analysis of covariance.
RESULTS


Workplace analyses included 1270 employed women and household analyses included 1565 women. At baseline, women reported average weekly losses of 16 workplace hours, 8.3 household work hours, 45% of scheduled work, and 64% of planned household chores. At Month 6, treatment with elagolix 150 mg QD or 200 mg BID increased productive workplace hours by 1.7 (95% CI 0.1-3.4; p = 0.041) and 5.4 h (95% CI 3.7-7.1; p < 0.001) relative to placebo, corresponding to gains of 5.2% (95% CI 0.7-9.7; p = 0.022) and 14.6% (95% CI 10.0-19.1; p < 0.001) of scheduled work, respectively. Both elagolix doses improved household productivity at Month 6 by 1.7 (95% CI 0.7-2.7) and 3.1 (95% CI 2.1-4.0) hours relative to placebo (both p < 0.001), with increases of 8.8% (95% CI 3.5-14.1; p = 0.001) and 20.4% (95% CI 15.1-25.6; p < 0.001) of planned household work.
CONCLUSIONS


Treatment with elagolix improved endometriosis-related workplace and household productivity impairments.
TRIAL REGISTRATION


ELARIS EM-I (NCT01620528) and ELARIS EM-II (NCT01931670).",2019,"Both elagolix doses improved household productivity at Month 6 by 1.7 (95% CI 0.7-2.7) and 3.1 (95% CI 2.1-4.0) hours relative to placebo (both p < 0.001), with increases of 8.8% (95% CI 3.5-14.1; p = 0.001) and 20.4% (95% CI 15.1-25.6; p < 0.001) of planned household work.
","['Women with Moderate to Severe Pain', 'Data were pooled from two phase III trials of women aged 18-49\xa0years with moderate to severe endometriosis-associated pain treated for 6\xa0months with elagolix 150\xa0mg daily (QD), 200\xa0mg twice daily (BID), or', '1270 employed women and household analyses included 1565 women', 'Associated with Endometriosis']","['placebo', 'elagolix 150\xa0mg QD', 'Elagolix']","['endometriosis-related workplace and household productivity impairments', 'household productivity', 'productive workplace hours', 'Productivity changes', 'Workplace and Household Productivity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4704599', 'cui_str': 'elagolix 150 MG [Orilissa]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4704599', 'cui_str': 'elagolix 150 MG [Orilissa]'}, {'cui': 'C2714632', 'cui_str': 'elagolix'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",1565.0,0.46874,"Both elagolix doses improved household productivity at Month 6 by 1.7 (95% CI 0.7-2.7) and 3.1 (95% CI 2.1-4.0) hours relative to placebo (both p < 0.001), with increases of 8.8% (95% CI 3.5-14.1; p = 0.001) and 20.4% (95% CI 15.1-25.6; p < 0.001) of planned household work.
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Surrey', 'Affiliation': 'Colorado Center for Reproductive Medicine, 10290 RidgeGate Circle, Lone Tree, CO, 80124, USA. ESurrey@colocrm.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Palac', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Agarwal', 'Affiliation': 'Center for Endometriosis Research and Treatment, University of California, San Diego, CA, USA.'}]",The patient,['10.1007/s40271-019-00394-7']
3041,2952046,Foscarnet (phosphonoformate sodium) in the treatment of recurrent male genital herpes.,"Foscarnet 0.3% cream was compared with placebo in a randomised double-blind study. The objective was to investigate the therapeutic efficacy and safety in men with recurrent genital herpes simplex virus (HSV) infections. A total of 51 patients were selected, of which 49 (25 treated with foscarnet) were valid for efficacy analysis. Different variables were analysed including the time to healing, alleviation of symptoms, side effects and the results of viral cultures. The median time to healing was 4 days in foscarnet treated patients compared to 5 days in placebo controls. The difference was not statistically significant (p = 0.22). However, foscarnet alleviated the severity of pain and also significantly reduced the median time to abolition pain to 3 days from 6.6 days in placebo treated patients (p = 0.0028). An antiviral effect of foscarnet was evident. The percentage of positive viral cultures found after starting treatment was 15% in the foscarnet-treated group compared to 44% in the placebo-treated group (p = 0.01). Treatment with foscarnet cream was not associated with any significant side effects.",1986,"However, foscarnet alleviated the severity of pain and also significantly reduced the median time to abolition pain to 3 days from 6.6 days in placebo treated patients (p = 0.0028).","['51 patients were selected, of which 49 (25 treated with', 'recurrent male genital herpes', 'men with recurrent genital herpes simplex virus (HSV) infections']","['placebo', 'foscarnet cream', 'foscarnet', 'Foscarnet (phosphonoformate sodium', 'Foscarnet 0.3% cream']","['severity of pain', 'median time to healing', 'percentage of positive viral cultures', 'median time to abolition pain', 'therapeutic efficacy and safety', 'time to healing, alleviation of symptoms, side effects and the results of viral cultures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017422', 'cui_str': 'Genitals, Male'}, {'cui': 'C0019340', 'cui_str': 'Herpes NOS'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1274323', 'cui_str': 'Recurrent herpes genitalis'}, {'cui': 'C0042769', 'cui_str': 'Viral Infections'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0070895', 'cui_str': 'Foscarnet'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0376236', 'cui_str': 'Phosphonoformate'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0200955', 'cui_str': 'Culture for viruses'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",51.0,0.227833,"However, foscarnet alleviated the severity of pain and also significantly reduced the median time to abolition pain to 3 days from 6.6 days in placebo treated patients (p = 0.0028).","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Doraisingham', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Thirumoorthy', 'Affiliation': ''}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Ling', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3042,31851556,Gemtuzumab Ozogamicin in  NPM1 -Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study.,"PURPOSE


High CD33 expression in acute myeloid leukemia (AML) with mutated  NPM1  provides a rationale for the evaluation of gemtuzumab ozogamicin (GO) in this AML entity. We conducted a randomized trial to evaluate GO in combination with intensive induction and consolidation therapy in  NPM1 -mutated AML.
PATIENTS AND METHODS


Between May 2010 and September 2017, patients ≥ 18 years old and considered eligible for intensive therapy were randomly assigned up front for induction therapy with idarubicin, cytarabine, etoposide, and all- trans -retinoic acid with or without GO. The early ( P  = .02) primary end point of event-free survival (EFS) was evaluated 6 months after completion of patient recruitment.
RESULTS


Five hundred eighty-eight patients were randomly assigned (standard arm, n = 296; GO arm, n = 292). EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04;  P  = .10). The early death rate during induction therapy was 10.3% in the GO arm and 5.7% in the standard arm ( P  = .05). Causes of death in both arms were mainly infections. The cumulative incidence of relapse (CIR) in patients achieving a complete remission (CR) or CR with incomplete hematologic recovery (CRi) was significantly reduced in the GO arm compared with the standard arm ( P  = .005), with no difference in the cumulative incidence of death ( P  = .80). Subgroup analysis revealed a significant beneficial effect of GO in female, younger (≤ 70 years), and  FLT3  internal tandem duplication-negative patients with respect to EFS and CIR.
CONCLUSION


The trial did not meet its early primary end point of EFS, mainly as a result of a higher early death rate in the GO arm. However, in patients achieving CR/CRi after induction therapy, significantly fewer relapses occurred in the GO compared with the standard arm.",2020,"EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04;  P  = .10).","['acute myeloid leukemia (AML', 'Five hundred eighty-eight patients', 'Acute Myeloid Leukemia', 'Between May 2010 and September 2017, patients ≥ 18 years old and considered eligible for intensive therapy']","['intensive induction and consolidation therapy', 'induction therapy with idarubicin, cytarabine, etoposide, and all- trans -retinoic acid with or without GO']","['cumulative incidence of death', 'cumulative incidence of relapse (CIR', 'relapses', 'complete remission (CR) or CR with incomplete hematologic recovery (CRi', 'event-free survival (EFS', 'early death rate']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",588.0,0.146388,"EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04;  P  = .10).","[{'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Paschka', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krzykalla', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Kapp-Schwoerer', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Verena I', 'Initials': 'VI', 'LastName': 'Gaidzik', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Leis', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'Department of Internal Medicine II, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kindler', 'Affiliation': 'Department of Hematology, Medical Oncology and Pneumology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schroeder', 'Affiliation': 'Department of Hematology, Oncology, and Clinical Immunology, University of Duesseldorf, Medical Faculty, Duesseldorf, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Internal Medicine III, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lübbert', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinikum Freiburg, Freiburg, Germany.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Department of Hematology and Oncology, Hospital Essen-Werden, Essen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Götze', 'Affiliation': 'Department of Internal Medicine III, University Hospital Klinikum Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Heinz A', 'Initials': 'HA', 'LastName': 'Horst', 'Affiliation': 'Department of Internal Medicine II, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'Department of Internal Medicine III, Hanuschkrankenhaus Wien, Wien, Austria.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schleicher', 'Affiliation': 'Klinikum der Landeshauptstadt Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bentz', 'Affiliation': 'Department of Hematology and Oncology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'IIIrd Medical Department, Paracelsus Medical University Salzburg; Salzburg Cancer Research Institute; and Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department Hematology and Oncology, Braunschweig Municipal Hospital, Braunschweig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Martens', 'Affiliation': 'Department of Hematology and Oncology, Klinikum am Gesundbrunnen, Heilbronn, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nachbaur', 'Affiliation': 'Department of Internal Medicine V, University Hospital of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Maisun', 'Initials': 'M', 'LastName': 'Abu Samra', 'Affiliation': 'Department of Internal Medicine IV, University Hospital of Gießen, Gießen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Girschikofsky', 'Affiliation': 'Department of Hematology and Oncology, Hospital Elisabethinen Linz, Linz, Austria.'}, {'ForeName': 'Nadezda', 'Initials': 'N', 'LastName': 'Basara', 'Affiliation': 'Department of Hematology and Oncology, Malteser Krankenhaus St Franziskus-Hospital, Flensburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Department of Hematology, Hemostaseology, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostaseology, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostaseology, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01406']
3043,30561704,Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial.,"OBJECTIVE


Examination of postoperative analgesia with intravenous and oral acetaminophen.
DESIGN


Prospective, three-arm, nonblinded, randomized clinical trial.
SETTING


A single academic medical center.
SUBJECTS


Parturients scheduled for elective cesarean delivery.
METHODS


This trial randomized 141 parturients to receive intravenous acetaminophen (1 g every eight hours, three doses), oral acetaminophen (1 g every eight hours, three doses), or no acetaminophen. All patients received a standardized neuraxial anesthetic with intrathecal opioids and scheduled postoperative ketorolac. The primary outcome, 24-hour opioid consumption, was evaluated using the Kruskal-Wallace test and Tukey-Kramer adjustment for multiple comparisons. Secondary outcomes included 48-hour opioid consumption, first opioid rescue, pain scores, patient satisfaction, times to ambulation and discharge, and side effects.
RESULTS


Over 18 months, 141 parturients with similar demographic variables completed the study. Median (interquartile range) opioid consumption in intravenous morphine milligram equivalents at 24 hours was 0 (5), 0 (7), and 5 (7) for the intravenous, oral, and no groups, respectively, and differed between groups (global P = 0.017). Opioid consumption and other secondary outcomes did not differ between the intravenous vs oral or oral vs no groups. Opioid consumption was reduced at 24 hours with intravenous vs no acetaminophen (P = 0.015). Patients receiving no acetaminophen had 5.8 times the odds of consuming opioids (P = 0.036), consumed 40% more opioids controlling for time (P = 0.041), and had higher pain scores with ambulation (P = 0.004) compared with the intravenous group.
CONCLUSIONS


Intravenous acetaminophen did not reduce 24-hour opioid consumption or other outcomes compared with oral acetaminophen. Intravenous acetaminophen did decrease opioid consumption and pain scores compared with no acetaminophen.",2019,"Patients receiving no acetaminophen had 5.8 times the odds of consuming opioids (P = 0.036), consumed 40% more opioids controlling for time (P = 0.041), and had higher pain scores with ambulation (P = 0.004) compared with the intravenous group.
","['141 parturients with similar demographic variables completed the study', 'Subjects\n\n\nParturients scheduled for elective cesarean delivery', '141 parturients to receive']","['intravenous and oral acetaminophen', 'Intravenous acetaminophen', 'standardized neuraxial anesthetic with intrathecal opioids and scheduled postoperative ketorolac', 'intravenous acetaminophen', 'Intravenous vs Oral Acetaminophen', 'acetaminophen', 'oral acetaminophen']","['odds of consuming opioids', '48-hour opioid consumption, first opioid rescue, pain scores, patient satisfaction, times to ambulation and discharge, and side effects', 'pain scores with ambulation', 'Opioid consumption', '24-hour opioid consumption', 'Kruskal-Wallace test and Tukey-Kramer adjustment for multiple comparisons', 'opioid consumption and pain scores']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]",141.0,0.249098,"Patients receiving no acetaminophen had 5.8 times the odds of consuming opioids (P = 0.036), consumed 40% more opioids controlling for time (P = 0.041), and had higher pain scores with ambulation (P = 0.004) compared with the intravenous group.
","[{'ForeName': 'Sylvia H', 'Initials': 'SH', 'LastName': 'Wilson', 'Affiliation': 'Departments of Anesthesia and Perioperative Medicine.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': 'Public Health Sciences.'}, {'ForeName': 'Stefanie M', 'Initials': 'SM', 'LastName': 'Robinson', 'Affiliation': 'Departments of Anesthesia and Perioperative Medicine.'}, {'ForeName': 'Cecil', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': 'Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Hebbar', 'Affiliation': 'Departments of Anesthesia and Perioperative Medicine.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny253']
3044,31919940,The effect of progressive muscle relaxation on the postpartum depression risk and general comfort levels in primiparas.,"In the postpartum period, mode of delivery, planned pregnancy, rapid changes in estrogen and progesterone hormone concentrations, quality of care, and environmental conditions affect the postpartum depression and comfort of the women. This study was conducted to evaluate the effect of progressive muscle relaxation (PMR) on the postpartum depression risk and general comfort levels in primiparas. A quasi-experimental design was used with pretest, post-test, and control group. The intervention and control groups consisted of 35 women each. PMR was applied to intervention group for 8 weeks. There was a statistically significant difference between Edinburgh Postnatal Depression Scale pretest and third follow-up scores of the intervention group (p < .05). There was a statistically significant difference between the intervention and control groups in the mean General Comfort Questionnaire scores at the first, second, and third follow-ups (p < .05). PMR may be effective on decreasing the postpartum depression risk and increasing general comfort. PMR could be administered through home visits to help women in postpartum period cope with their mental health problems after discharge.",2020,"There was a statistically significant difference between the intervention and control groups in the mean General Comfort Questionnaire scores at the 1st, 2nd and 3rd follow-ups (p < 0.05).","['primiparas', 'Primiparas']","['progressive muscle relaxation (PMR', 'Progressive Muscle Relaxation', 'PMR']","['estrogen and progesterone hormone concentrations, quality of care and environmental conditions affect the postpartum depression and comfort of the women', 'Edinburgh Postnatal Depression Scale pre-test and 3 rd  follow-up scores', 'mean General Comfort Questionnaire scores', 'Postpartum Depression Risk and General Comfort Levels']",[],"[{'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}]","[{'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}]",35.0,0.0218249,"There was a statistically significant difference between the intervention and control groups in the mean General Comfort Questionnaire scores at the 1st, 2nd and 3rd follow-ups (p < 0.05).","[{'ForeName': 'İlknur', 'Initials': 'İ', 'LastName': 'Gökşin', 'Affiliation': 'Faculty of Health Sciences, Nursing Department, Aksaray University, Aksaray, Turkey.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Ayaz-Alkaya', 'Affiliation': 'Faculty of Health Sciences, Nursing Department, Gazi University, Ankara, Turkey.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2921']
3045,30698771,Prolotherapy vs Radial Extracorporeal Shock Wave Therapy in the Short-term Treatment of Lateral Epicondylosis: A Randomized Clinical Trial.,"OBJECTIVE


The aim of this study was to compare the efficacy of prolotherapy with hypertonic dextrose and radial shock wave therapy in chronic lateral epicondilosis.
DESIGN


Prospective single-blind randomized clinical trial.
SETTING


Physical medicine and rehabilitation clinic.
SUBJECTS


Thirty-three patients with at least three months of signs and symptoms of lateral epicondilosis, as well as failure of at least one of the conservative treatments, randomly allocated into two groups.
METHODS


Sixteen patients received three sessions of shock wave therapy, and 17 received one session prolotherapy. Severity of pain via visual analog scale (VAS), grip strength via Baseline Pneumatic Dynamometer, pressure pain threshold (PPT) by algometer and Disabilities of Arm, Shoulder, and Hand quick questionnaire (Quick DASH) were assessed at baseline, four weeks, and eight weeks after the intervention.
RESULTS


Within-group analysis showed that in both groups, differences between all of the outcome measures were significant after four and also eight weeks. Between-group analysis after four and eight weeks showed that the VAS and Quick DASH had significantly more improvement in the shock wave group. However, the two groups were similar regarding grip strength and PPT. No complication was observed in the two groups.
CONCLUSIONS


Based on the results of this study, a regiment of three sessions (weekly) of radial extracorporeal shock wave therapy is significantly more effective than one session of prolotherapy with 20% dextrose regarding pain and function in the management of chronic lateral epicondylosis in short-term follow-up.",2019,Between-group analysis after four and eight weeks showed that the VAS and Quick DASH had significantly more improvement in the shock wave group.,"['Lateral Epicondylosis', 'Subjects\n\n\nThirty-three patients with at least three months of signs and symptoms of lateral epicondilosis, as well as failure of at least one of the conservative treatments']","['radial extracorporeal shock wave therapy', 'shock wave therapy, and 17 received one session prolotherapy', 'Prolotherapy vs Radial Extracorporeal Shock Wave Therapy', 'prolotherapy with hypertonic dextrose and radial shock wave therapy']","['grip strength and PPT', 'Severity of pain via visual analog scale (VAS), grip strength via Baseline Pneumatic Dynamometer, pressure pain threshold (PPT) by algometer and Disabilities of Arm, Shoulder, and Hand quick questionnaire (Quick DASH', 'No complication', 'VAS and Quick DASH']","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0500223', 'cui_str': 'Proliferation Therapy'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",33.0,0.0758301,Between-group analysis after four and eight weeks showed that the VAS and Quick DASH had significantly more improvement in the shock wave group.,"[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ahadi', 'Affiliation': 'Neuromusculoskeletal Research Centre, Firoozgar Hospital.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Esmaeili Jamkarani', 'Affiliation': 'Neuromusculoskeletal Research Centre, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Raissi', 'Affiliation': 'Neuromusculoskeletal Research Centre, Firoozgar Hospital.'}, {'ForeName': 'Korosh', 'Initials': 'K', 'LastName': 'Mansoori', 'Affiliation': 'Neuromusculoskeletal Research Centre, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyede Zahra', 'Initials': 'SZ', 'LastName': 'Emami Razavi', 'Affiliation': 'Physical medicine and rehabilitation department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Sajadi', 'Affiliation': 'Neuromusculoskeletal Research Centre, Iran University of Medical Sciences, Tehran, Iran.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny303']
3046,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3047,31829907,"Randomized Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel Versus Docetaxel in Advanced Non-Small-Cell Lung Cancer (GALAXY-2).","PURPOSE


Ganetespib, a highly potent heat shock protein 90 inhibitor, blocks multiple oncogenic pathways, resulting in antitumor activity. We evaluated the combination of ganetespib and docetaxel for second-line therapy of patients with advanced adenocarcinoma of the lung.
PATIENTS AND METHODS


In this international phase III trial, patients with stage IIIB or IV adenocarcinoma diagnosed > 6 months before study entry and 1 prior systemic therapy were randomly assigned (1:1) to ganetespib 150 mg/m 2  on days 1 and 15 with docetaxel 75 mg/m 2  on day 1 of a 21-day cycle or to docetaxel alone. The primary end point was overall survival (OS).
RESULTS


Of 677 enrolled patients, 335 were randomly assigned to ganetespib and docetaxel and 337 were assigned to docetaxel. The trial was stopped early as a result of futility at a planned interim analysis. The median OS time was 10.9 months (95% CI, 9.0 to 12.3 months) in the ganetespib and docetaxel arm compared with 10.5 months (95% CI, 8.6 to 12.2 months) in docetaxel arm (hazard ratio [HR], 1.11; 95% CI, 0.899 to 1.372;  P  = .329). Median progression-free survival was 4.2 months in the ganetespib and docetaxel arm and 4.3 months in the docetaxel arm (HR, 1.16; 95% CI, 0.96 to 1.403;  P  = .119). The addition of ganetespib did not improve outcomes compared with docetaxel alone for any secondary end point, including survival in the elevated lactate dehydrogenase or EGFR and ALK wild-type populations. The most common grade 3 or 4 adverse event in both arms was neutropenia (30.9% with ganetespib and docetaxel  v  25% with docetaxel).
CONCLUSION


The addition of ganetespib to docetaxel did not result in improved survival for salvage therapy of patients with advanced-stage lung adenocarcinoma.",2020,"The addition of ganetespib did not improve outcomes compared with docetaxel alone for any secondary end point, including survival in the elevated lactate dehydrogenase or EGFR and ALK wild-type populations.","['Advanced Non-Small-Cell Lung Cancer (GALAXY-2', 'patients with advanced-stage lung adenocarcinoma', 'patients with stage IIIB or IV adenocarcinoma diagnosed > 6 months before study entry and 1 prior systemic therapy', '677 enrolled patients', 'patients with advanced adenocarcinoma of the lung']","['docetaxel', 'docetaxel alone', 'ganetespib and docetaxel', 'Ganetespib', 'Docetaxel Versus Docetaxel', 'ganetespib 150 mg/m 2  on days 1 and 15 with docetaxel']","['overall survival (OS', 'survival', 'Median progression-free survival', 'neutropenia', 'median OS time']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0282063', 'cui_str': 'Galaxies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3467824'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",677.0,0.0704499,"The addition of ganetespib did not improve outcomes compared with docetaxel alone for any secondary end point, including survival in the elevated lactate dehydrogenase or EGFR and ALK wild-type populations.","[{'ForeName': 'Rathi N', 'Initials': 'RN', 'LastName': 'Pillai', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kovcin', 'Affiliation': 'Clinical Hospital Centre Bežanijska Beograd, Belgrade, Serbia.'}, {'ForeName': 'Tudor-Eliade', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Prof Dr Ion Chiricuţă Institute of Oncology and Universitatea de Medicină şi Farmacie Iuliu Hatiegan, Cluj-Napoca, Romania.'}, {'ForeName': 'Rodryg', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'University of Medicine and Pharmacy Craiova, Craiova, Romania.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Yalcin', 'Affiliation': 'Synta Pharmaceuticals, West Conshohocken, PA.'}, {'ForeName': 'Florentina', 'Initials': 'F', 'LastName': 'Teofilovici', 'Affiliation': 'Synta Pharmaceuticals, West Conshohocken, PA.'}, {'ForeName': 'Vojo M', 'Initials': 'VM', 'LastName': 'Vukovic', 'Affiliation': 'Synta Pharmaceuticals, West Conshohocken, PA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00816']
3048,2800898,Randomised double-blind placebo-controlled trial of local cyclosporin in atopic dermatitis.,"The efficacy of local applications of 10% cyclosporin gel was studied in a randomised double-blind placebo-controlled trial in atopic dermatitis. Twenty atopic patients, presenting with stable symmetrical lesions, participated in the study. They applied cyclosporin gel to one side and placebo gel to the other side twice a day. The lesions were assessed on day 0 and day 14 according to lesional criteria scored from 0 to 3. The mean score for each criterion on day 14 was significantly lower on the sides treated with cyclosporin than on the sides treated with placebo. The total mean score on day 14 was 6.1 +/- 3.9 on the sides treated with CSA and 9.6 +/- 3.9 for placebo (p less than 0.005). These findings suggest the efficacy of local CSA applications on lesions of atopic dermatitis.",1989,The mean score for each criterion on day 14 was significantly lower on the sides treated with cyclosporin than on the sides treated with placebo.,"['atopic dermatitis', 'Twenty atopic patients, presenting with stable symmetrical lesions, participated in the study']","['CSA', 'local cyclosporin', 'placebo', 'cyclosporin', 'cyclosporin gel', 'local CSA applications']","['mean score', 'total mean score']","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",20.0,0.103023,The mean score for each criterion on day 14 was significantly lower on the sides treated with cyclosporin than on the sides treated with placebo.,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'de Prost', 'Affiliation': 'Unité de Dermatologie, Hôpital Necker Enfants Malades, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bodemer', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Teillac', 'Affiliation': ''}]",Acta dermato-venereologica. Supplementum,[]
3049,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3050,31990424,Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study).,"BACKGROUND


Vonoprazan (V), a potassium-competitive acid blocker, has a more durable acid-inhibitory effect as compared with standard-dose proton pump inhibitors (PPIs) but has not been compared with 2-4 times higher daily PPI doses administered in two divided doses.
AIMS


To evaluate the acid-inhibitory effect of V 10/20 mg once-daily (OD; V10/V20) vs rabeprazole (R) 10/20 mg twice-daily (BID; R20/R40) in healthy Japanese volunteers.
METHODS


This multicentre, randomised, open-label, two-period, crossover study compared V10 or V20 vs R20, or V20 vs R40 using three cohorts of 10 healthy Japanese adults. Within each cohort, subjects were randomised to receive V or R for 7 days and, following a washout period ≥7 days, the other treatment for 7 days. On day 6 of each period, 24-hours multichannel gastric impedance-pH monitoring was performed. Percent times pH ≥ 3, ≥4 and ≥5 (pH 3, 4 and 5 holding time ratios [HTRs]) in 24 hours were evaluated as primary pharmacodynamic endpoints.
RESULTS


Acid-inhibitory effect (24-hours pH 3 HTR) of V20 was greater than those of R20 (91.0% vs 65.3%; P = .0049) and R40 (98.5% vs 85.9%; P = .0073). Similar results were obtained for 24-hours pH 4 and 5 HTRs. V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40. One subject (20%) developed diarrhoea while receiving R40 which was considered treatment-related.
CONCLUSIONS


Compared with 2-4 times the standard daily dose of R, V20 exerts a more potent and durable acid-inhibitory effect. Trial identifier: UMIN000022198 (www.umin.ac.jp/ctr/index.htm).",2020,V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40.,"['healthy Japanese volunteers (SAMURAI pH study', '10 healthy Japanese adults', 'healthy Japanese volunteers']","['rabeprazole', 'V10 or V20 vs R20, or V20 vs R40', 'acid inhibition by vonoprazan']","['diarrhoea', 'nocturnal pH']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}]",,0.116304,V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40.,"[{'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Endoscopic Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Furuta', 'Affiliation': 'Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine School of Medicine, Osaka, Japan.'}, {'ForeName': 'Mitsushige', 'Initials': 'M', 'LastName': 'Sugimoto', 'Affiliation': 'Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Otsu, Japan.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Kasugai', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Motoyasu', 'Initials': 'M', 'LastName': 'Kusano', 'Affiliation': 'Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Meabashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Kagami', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Uotani', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Yamade', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Akinari', 'Initials': 'A', 'LastName': 'Sawada', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine School of Medicine, Osaka, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine School of Medicine, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Endoscopic Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Otsu, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Funaki', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kawamura', 'Affiliation': 'Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Meabashi, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Internal Medicine, Saga Medical School, Saga, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15641']
3051,32058596,Enhancement of Fat Oxidation during Submaximal Exercise in Sedentary Persons: Variations by Medium-Chain Fatty Acid Composition and Age Group.,"Previous studies in recreational and trained athletes aged mostly in their 20s have reported that short-term ingestion of medium-chain triacylglycerols (MCT) enhances fat oxidation (FAO) during submaximal exercise. However, whether the FAO-enhancing effect of MCT with a different composition of medium-chain fatty acids (MCFA) occurs in older sedentary persons is unclear. The present study investigated the effect of MCT ingestion with different proportions of MCFA in sedentary participants in their 40's and 50's. Participants ingested 0 g of MCT (control), 6 g of octanoic acid-rich MCT (OAR), or 6 g of decanoic acid-rich MCT (DAR) for 14 days separated by a 14-day washout period in random order. Cumulative FAO (F cv  ) during submaximal, fixed, and incremental exercise was evaluated at workload from 20 W to the appearance of a ventilation threshold (VT). During the 20 W fixed-load exercise, F cv  was significantly (p < 0.05) higher in the OAR than in the control. At appearance of VT, intervention effect of power output was significantly higher in the OAR and DAR than in the control. In a subgroup analysis by age, intervention effects of maximal FAO rate and oxygen uptake in the upper age subgroup were higher in the OAR and DAR than in the control. In a pooled analysis with age subgroup and diet, the integrated pooled estimate of F cv  during submaximal exercise was significantly higher in 6 g of MCT ingestion than 0 g ingestion. Our data show that the effect of MCT might differ depending on the age group and the proportion of MCFA, while MCT could enhance FAO during submaximal exercise.",2020,"At appearance of VT, intervention effect of power output was significantly higher in the OAR and DAR than in the control.","['Sedentary Persons', ""sedentary participants in their 40's and 50's"", 'older sedentary persons']","['MCT', 'MCT (control), 6 g of octanoic acid-rich MCT (OAR), or 6 g of decanoic acid-rich MCT (DAR', 'MCT ingestion', 'MCFA', 'Fat Oxidation during Submaximal Exercise']","['maximal FAO rate and oxygen uptake', 'Cumulative FAO (F cv  ) during submaximal, fixed, and incremental exercise', 'power output', 'OAR and DAR']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0054616', 'cui_str': 'caprylic acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0057239', 'cui_str': 'decanoic acid'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}]",,0.0511113,"At appearance of VT, intervention effect of power output was significantly higher in the OAR and DAR than in the control.","[{'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Nosaka', 'Affiliation': 'Central Research Laboratory, The Nisshin OilliO Group, Ltd., 1 Shinmori-Cho, Isogo-ku, Yokohama, Kanagawa, 235-8558, Japan.'}, {'ForeName': 'Shougo', 'Initials': 'S', 'LastName': 'Tsujino', 'Affiliation': 'Central Research Laboratory, The Nisshin OilliO Group, Ltd., 1 Shinmori-Cho, Isogo-ku, Yokohama, Kanagawa, 235-8558, Japan.'}, {'ForeName': 'Kazumitsu', 'Initials': 'K', 'LastName': 'Honda', 'Affiliation': 'The Nisshin OilliO Group, Ltd., 1 Shinmori-Cho, Isogo-ku, Yokohama, Kanagawa, 235-8558, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Suemitsu', 'Affiliation': 'Kato Clinic, 1-1-1 Nakaizumi, Komae, Tokyo, 201-0012, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Kato Clinic, 1-1-1 Nakaizumi, Komae, Tokyo, 201-0012, Japan.'}]",Lipids,['10.1002/lipd.12222']
3052,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3053,32058351,Effects of Directional Microphone and Noise Reduction on Subcortical and Cortical Auditory-Evoked Potentials in Older Listeners With Hearing Loss.,"OBJECTIVES


Understanding how signal processing influences neural activity in the brain with hearing loss is relevant to the design and evaluation of features intended to alleviate speech-in-noise deficits faced by many hearing aid wearers. Here, we examine whether hearing aid processing schemes that are designed to improve speech-in-noise intelligibility (i.e., directional microphone and noise reduction) also improve electrophysiological indices of speech processing in older listeners with hearing loss.
DESIGN


The study followed a double-blind within-subjects design. A sample of 19 older adults (8 females; mean age = 73.6 years, range = 56-86 years; 17 experienced hearing aid users) with a moderate to severe sensorineural hearing impairment participated in the experiment. Auditory-evoked potentials associated with processing in cortex (P1-N1-P2) and subcortex (frequency-following response) were measured over the course of two 2-hour visits. Listeners were presented with sequences of the consonant-vowel syllable /da/ in continuous speech-shaped noise at signal to noise ratios (SNRs) of 0, +5, and +10 dB. Speech and noise stimuli were pre-recorded using a Knowles Electronics Manikin for Acoustic Research (KEMAR) head and torso simulator outfitted with hearing aids programmed for each listener's loss. The study aid programs were set according to 4 conditions: (1) omnidirectional microphone, (2) omnidirectional microphone with noise reduction, (3) directional microphone, and (4) directional microphone with noise reduction. For each hearing aid condition, speech was presented from a loudspeaker located at 1 m directly in front of KEMAR (i.e., 0° in the azimuth) at 75 dB SPL and noise was presented from a matching loudspeaker located at 1 m directly behind KEMAR (i.e., 180° in the azimuth). Recorded stimulus sequences were normalized for speech level across conditions and presented to listeners over electromagnetically shielded ER-2 ear-insert transducers. Presentation levels were calibrated to match the output of listeners' study aids.
RESULTS


Cortical components from listeners with hearing loss were enhanced with improving SNR and with use of a directional microphone and noise reduction. On the other hand, subcortical components did not show sensitivity to SNR or microphone mode but did show enhanced encoding of temporal fine structure of speech for conditions where noise reduction was enabled.
CONCLUSIONS


These results suggest that auditory-evoked potentials may be useful in evaluating the benefit of different noise-mitigating hearing aid features.",2020,"RESULTS


Cortical components from listeners with hearing loss were enhanced with improving SNR and with use of a directional microphone and noise reduction.","['Older Listeners With Hearing Loss', 'older listeners with hearing loss', 'listeners with hearing loss', '19 older adults (8 females; mean age = 73.6 years, range = 56-86 years; 17 experienced hearing aid users) with a moderate to severe sensorineural hearing impairment participated in the experiment']","['Directional Microphone and Noise Reduction', 'omnidirectional microphone, (2) omnidirectional microphone with noise reduction, (3) directional microphone, and (4) directional microphone with noise reduction', ""consonant-vowel syllable /da/ in continuous speech-shaped noise at signal to noise ratios (SNRs) of 0, +5, and +10 dB. Speech and noise stimuli were pre-recorded using a Knowles Electronics Manikin for Acoustic Research (KEMAR) head and torso simulator outfitted with hearing aids programmed for each listener's loss""]",['Auditory-evoked potentials associated with processing in cortex (P1-N1-P2) and subcortex (frequency-following response'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0035168'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015215', 'cui_str': 'Auditory Evoked Potentials'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",19.0,0.017341,"RESULTS


Cortical components from listeners with hearing loss were enhanced with improving SNR and with use of a directional microphone and noise reduction.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Slugocki', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Kuk', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois, USA.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Korhonen', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois, USA.'}]",Ear and hearing,['10.1097/AUD.0000000000000847']
3054,32032096,"Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium: A Mediation Analysis.","BACKGROUND


Postoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium.
METHODS


This is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5.
RESULTS


Among 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation).
CONCLUSIONS


A small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.",2020,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","['1,113 patients, 430 patients', 'patients with preexisting cognitive impairment', 'enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018']","['Intraoperative electroencephalogram suppression', 'Electroencephalography Guidance of Anesthesia', 'electroencephalogram-guided anesthesia or usual care', 'intraoperative electroencephalogram suppression']","['Postoperative delirium', 'Duration of intraoperative electroencephalogram suppression', 'incidence of postoperative delirium', 'Preoperative abnormal cognition', 'preoperative abnormal cognition', 'postoperative delirium', 'Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.120379,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","[{'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'From the Department of Anesthesiology (B.A.F., C.R.K., A.B., A.M.M., T.P.B., J.O., D.P., H.R.M., T.S.W., M.S.A) the Division of Biostatistics (N.L.), Washington University School of Medicine, St. Louis, Missouri the Department of Mathematics and Statistics, Washington University in St. Louis, St. Louis, Missouri (N.L.). Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, University of Manitoba, Winnipeg, Canada Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Mickle', 'Affiliation': ''}, {'ForeName': 'Thaddeus P', 'Initials': 'TP', 'LastName': 'Budelier', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oberhaus', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Maybrier', 'Affiliation': ''}, {'ForeName': 'Troy S', 'Initials': 'TS', 'LastName': 'Wildes', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': ''}, {'ForeName': 'Ginika', 'Initials': 'G', 'LastName': 'Apakama', 'Affiliation': ''}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Aranake-Chrisinger', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bolzenius', 'Affiliation': ''}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Emmert', 'Affiliation': ''}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Goswami', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Graetz', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kronzer', 'Affiliation': ''}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'McKinnon', 'Affiliation': ''}, {'ForeName': 'Maxwell R', 'Initials': 'MR', 'LastName': 'Muench', 'Affiliation': ''}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Palanca', 'Affiliation': ''}, {'ForeName': 'Aamil', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Tracey W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Strutz', 'Affiliation': ''}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tedeschi', 'Affiliation': ''}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Trammel', 'Affiliation': ''}, {'ForeName': 'Ravi T', 'Initials': 'RT', 'LastName': 'Upadhyayula', 'Affiliation': ''}, {'ForeName': 'Anke C', 'Initials': 'AC', 'LastName': 'Winter', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Fong', 'Affiliation': ''}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': ''}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Schmitt', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerville', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ''}, {'ForeName': 'Spencer J', 'Initials': 'SJ', 'LastName': 'Melby', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tappenden', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003181']
3055,31898055,The effects of stress and transcranial direct current stimulation (tDCS) on working memory: A randomized controlled trial.,"Recent reviews of transcranial direct current stimulation (tDCS) show limited support for its initially cited enhancing effects on working memory (WM). They highlight the need for additional research, assessing the specific circumstances that optimize stimulation outcome. Social stress is an attractive candidate in this regard, as it affects WM and is mediated by prefrontal cortex activity; tDCS that targets these neuronal networks may, therefore, interact with social stress to affect WM. Our objective was to explore the interaction between social stress and tDCS on WM performance in a healthy cohort, 69 female participants were randomized to four experimental conditions (i.e., 2 × 2 design): stimulation (dlPFC tDCS vs. sham stimulation) and stress manipulation (Trier Social Stress Test [TSST] procedure vs. a friendly control TSST). Participants' attention, WM (assessed using an n-back task), and subjective/objective indicators of stress were assessed. A significant Stimulation × Stress Manipulation interaction was found, F(1, 65) = 6.208, p = .015, suggesting that active tDCS may increase WM performance in the no-stress conditions, while decreasing it under stress. Follow-up analyses of variance, however, were not significant (i.e., ps=.083 / .093), and Bayesian analyses were inconclusive. In conclusion, stress seems to be a crucial factor in determining the effects of tDCS, and tDCS may have an enhancing effect on WM at lower levels of stress, while being detrimental at higher stress levels (i.e., reversing the direction of effect). Possible theoretical underpinnings of the findings are discussed, while acknowledging the need for further research.",2020,"Follow-up analyses of variance, however, were not significant (i.e., ps=.083 / .093), and Bayesian analyses were inconclusive.","['a healthy cohort, 69 female participants']","['stimulation (dlPFC tDCS vs. sham stimulation) and stress manipulation (Trier Social Stress Test [TSST] procedure vs. a friendly control TSST', 'stress and transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation (tDCS']","['WM performance', 'working memory']","[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}]",69.0,0.0476769,"Follow-up analyses of variance, however, were not significant (i.e., ps=.083 / .093), and Bayesian analyses were inconclusive.","[{'ForeName': 'Yael L E', 'Initials': 'YLE', 'LastName': 'Ankri', 'Affiliation': 'Department of Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Braw', 'Affiliation': 'Department of Psychology, Ariel University, Ariel, Israel. yoramb@ariel.ac.il.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Luboshits', 'Affiliation': 'Department of Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Meiron', 'Affiliation': 'Clinical Research Center for Brain Sciences, Herzog Medical Center, Jerusalem, Israel.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-019-00755-7']
3056,32043342,"Neuromuscular, hormonal and cardiovascular adaptations to eight-week HIIT and continuous aerobic training combined with neuromuscular electrical stimulation.","BACKGROUND


Whether high-or-low intensity exercise coupled with neuromuscular electrostimulation (NMES) affect IGF-1 and IGFBP-1 is unknown. The scope of this study was to test whether 8-week high-intensity interval training (HIIT) and continuous aerobic training (CA) combined with/without NMES performed at 65% and 120% of VO2max on a cycle ergometer induce different metabolic adaptations.
METHODS


A randomized controlled trial with a parallel groups study design was used. Thirty healthy untrained male participants (age: 21.33±1.24 years, height: 177.80±5.97 cm, weight: 73.74±7.90 kg, lean body mass: 64.29±5.11 kg, percent body fat: 12.43±5.34%) voluntarily participated in this study. Six participants were allocated to Control, six to HIIT, six to HIIT+NMES, six to CA, and six to CA+NMES.
RESULTS


Pre- to post-test IVO2max, blood lactate concentrations, O2 kinetics, peak torques at 60o/s and 180o/s were found statistically significant (P<0.05, P<0.001). IGF-1 pre 15 min in CA and IGF-1 post 30 min in HIIT group was found significantly higher compared to control group (16.93±8.40 vs. 6.05±4.25, P=0.024; 10.80±3.94 vs. 6.15±2.56, P=0.037), respectively. Additionally, IGFBP-1 were found significantly higher in CA+NMES group than HIIT group (0.95±0.67 vs. 1.23±0.56). Eight week post IGF-1/IGFBP-1 ratios were found higher in pre 15 min, post 30 min and post 24 h compared to baseline pre 15 min, post 30 min and post 24 h measurements in all groups (8.92±4.72 vs. 3.93±3.14; 9.41±3.72 vs. 3.99±1.76; 8.63±3.01 vs. 5.89±3.01, respectively). Also, IGFBP-1 post 30 min was significantly lower in HIIT+NMES while CA group showed significantly lower baseline and 24 h post IGFBP-1 compared to pre-test measurements (Z=-3.20, P=0.001; Z=-3.72, P=0.000; Z=-2.93, P=0.000).
CONCLUSIONS


HIIT and CA training induce different stimuli on IGF-1 and IGFBP-1 and NMES application combined with high-and-low intensity exercise is highly effective in improving athletic performance.",2020,"IGF-1/IGFBP-1 ratios were found higher in pre 15 min, post 30 min and post 24 h compared to baseline pre 15 min, post 30 min and post 24 h measurements in all groups (8.92±4.72 vs 3.93±3.14;","['Thirty healthy untrained male participants (age:21.33±1.24years, height:177.80±5.97cm, weight:73.74±7.90kg, lean body mass:64.29±5.11kg, percent body fat:12.43±5.34%) voluntarily participated in this study']","['8-week High-Intensity Interval Training (HIIT) and Continuous Aerobic Training (CA) combined with/without NMES', 'continuous aerobic training combined with neuromuscular electrical stimulation', 'high-or-low intensity exercise coupled with neuromuscular electrostimulation (NMES', 'HIIT and CA training']","['IGF-1/IGFBP-1 ratios', 'IGFBP-1', 'athletic performance', 'IVO2max, blood lactate concentrations, O2 kinetics, peak torques', 'IGFBP-1 post 30min']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123256', 'cui_str': 'IGFBP-1'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",6.0,0.0665087,"IGF-1/IGFBP-1 ratios were found higher in pre 15 min, post 30 min and post 24 h compared to baseline pre 15 min, post 30 min and post 24 h measurements in all groups (8.92±4.72 vs 3.93±3.14;","[{'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Umutlu', 'Affiliation': 'School of Physical Education and Sports, Final International University, Kyrenia, Cyprus - gokhan.umutlu@final.edu.tr.'}, {'ForeName': 'Nevzat', 'Initials': 'N', 'LastName': 'Demirci', 'Affiliation': 'School of Physical Education and Sports, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Ayhan T', 'Initials': 'AT', 'LastName': 'Erdoğan', 'Affiliation': 'School of Physical Education and Sports, Final International University, Kyrenia, Cyprus.'}, {'ForeName': 'Nasuh E', 'Initials': 'NE', 'LastName': 'Acar', 'Affiliation': 'School of Physical Education and Sports, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Şenay B', 'Initials': 'ŞB', 'LastName': 'Fidanci', 'Affiliation': 'School of Medicine, Department of Medical Chemistry, Mersin University, Mersin, Turkey.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10277-0']
3057,32008990,Comparison of Different Kinesio Taping Techniques After Third Molar Surgery.,"PURPOSE


Elastic therapeutic taping method has been shown to reduce pain and edema after surgery. The purpose of the present study was to compare the effects of 2 different Kinesio taping (KT) techniques on swelling, pain, and trismus after third molar surgery.
PATIENTS AND METHODS


The study was designed as a split-mouth, single-blinded, and controlled randomized clinical trial. Patients undergoing lower impacted third molar extraction at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, were included in the present study. Group I included 30 patients and was used to compare the classic KT technique (technique A) and the new KT technique (technique B). Group II included 15 patients and was used to compare the classic KT technique (technique A) and no KT (No-KT [control]). Group III included 15 patients and was used to compare the new KT technique (technique B) and No-KT (control). Swelling was assessed using the 3dMD Face System (3dMD, Atlanta, GA). The maximum interincisal distance was recorded using a digital caliper preoperatively (T0) and at postoperative days 2 (T1) and 7 (T2). The visual analog scale for pain scores were recorded postoperatively at 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours, and 1, 2, 3, 4, 5, 6, and 7 days. The effects of operative time, patient age, and patient gender were also evaluated.
RESULTS


The data from 60 patients (27 men and 33 women) with a mean age of 22.28 years (range, 18 to 31 years) were analyzed in the present study. The amount of swelling and the interincisal distance were less with technique B than with technique A and no KT (control group).
CONCLUSIONS


KT is a useful method for reducing postoperative morbidity after impacted third molar extraction. In particular, the application of KT using the new technique described in the present study could be more effective than the classic methods.",2020,"The amount of swelling and the interincisal distance were less with technique B than with technique A and no KT (control group).
","['Patients undergoing lower impacted third molar extraction at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, were included in the present study', '60 patients (27 men and 33 women) with a mean age of 22.28\xa0years (range, 18 to 31\xa0years']","['Kinesio Taping Techniques', 'classic KT technique (technique A) and the new KT technique (technique B', 'new KT technique (technique B) and No-KT (control', 'classic KT technique (technique A) and no KT (No-KT [control', 'Kinesio taping (KT) techniques']","['pain and edema', 'amount of swelling and the interincisal distance', 'visual analog scale for pain scores', 'maximum interincisal distance', '3dMD Face System (3dMD, Atlanta, GA', 'swelling, pain, and trismus', 'postoperative morbidity', 'Swelling']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}]",60.0,0.0384293,"The amount of swelling and the interincisal distance were less with technique B than with technique A and no KT (control group).
","[{'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Gözlüklü', 'Affiliation': 'Private Practice, Dental Clinic, İzmir, Turkey. Electronic address: ozgurgozluklu@hotmail.com.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ulu', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, Aydınlıkevler, Turkey.'}, {'ForeName': 'Hilal Öztürk', 'Initials': 'HÖ', 'LastName': 'Gözlüklü', 'Affiliation': 'Physiotherapist and Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Manisa Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Nergiz', 'Initials': 'N', 'LastName': 'Yilmaz', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, Aydınlıkevler, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.12.026']
3058,30628055,A randomized phase II study evaluating vismodegib as neoadjuvant treatment of basal cell carcinoma preceding Mohs micrographic surgery: results and lessons learned.,,2019,,['basal cell carcinoma preceding Mohs micrographic surgery'],['vismodegib'],[],"[{'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}]","[{'cui': 'C2987716', 'cui_str': 'vismodegib'}]",[],,0.0129505,,"[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Soon', 'Affiliation': 'Scripps Clinic, La Jolla, CA, U.S.A.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Ibrahim', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, U.S.A.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Arron', 'Affiliation': 'University of California San Francisco Medical Center, San Francisco, CA, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17623']
3059,30734266,Efficacy and safety of mirikizumab (LY3074828) in the treatment of moderate-to-severe plaque psoriasis: results from a randomized phase II study.,"BACKGROUND


Inhibiting interleukin (IL)-23 in patients with psoriasis has demonstrated high levels of skin clearance.
OBJECTIVES


To investigate, in a phase II (AMAF; NCT02899988), multicentre, double-blind trial, the efficacy and safety of three doses of mirikizumab (LY3074828), a p19-directed IL-23 antibody, vs. placebo in patients with moderate-to-severe plaque psoriasis.
METHODS


Adult patients were randomized 1 : 1 : 1 : 1 to receive placebo (n = 52), mirikizumab 30 mg (n = 51), mirikizumab 100 mg (n = 51) or mirikizumab 300 mg (n = 51) subcutaneously at weeks 0 and 8. The primary objective was to evaluate the superiority of mirikizumab over placebo in achieving a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) response at week 16. Comparisons were done using logistic regression analysis with treatment, geographical region and previous biological therapy in the model. Missing data were imputed as nonresponses.
RESULTS


Ninety-seven per cent of patients completed the first 16 weeks of the study. The primary end point was met for all mirikizumab dose groups vs. placebo, with PASI 90 response rates at week 16 of 0%, 29% (P = 0·009), 59% (P < 0·001) and 67% (P < 0·001) for patients receiving placebo, and mirikizumab 30 mg, 100 mg and 300 mg, respectively. There were two (1%) serious adverse events in mirikizumab-treated patients vs. one (2%) in a placebo-group patient.
CONCLUSIONS


At week 16, 67% of patients treated with mirikizumab 300 mg at 8-week intervals achieved PASI 90. The percentage of patients reporting at least one treatment-emergent adverse event was similar among patients treated with placebo or mirikizumab.",2019,The percentage of patients reporting at least one treatment-emergent adverse event was similar among patients treated with placebo or mirikizumab.,"['patients with psoriasis', 'patients with moderate-to-severe plaque psoriasis', 'Adult patients', 'moderate-to-severe plaque psoriasis']","['placebo', 'mirikizumab', 'placebo or mirikizumab', 'mirikizumab (LY3074828), a p19-directed IL-23 antibody, vs. placebo', 'mirikizumab 30 mg (n = 51), mirikizumab 100 mg (n = 51) or mirikizumab', 'mirikizumab over placebo', 'mirikizumab (LY3074828']","['PASI 90 response rates', 'Psoriasis Area and Severity Index (PASI 90) response', 'Efficacy and safety', 'efficacy and safety', 'serious adverse events', 'percentage of patients reporting at least one treatment-emergent adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.356925,The percentage of patients reporting at least one treatment-emergent adverse event was similar among patients treated with placebo or mirikizumab.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Dermatologikum Berlin, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rich', 'Affiliation': 'Dermatology and Clinical Research, Oregon Health Science University, Portland, OR, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'St Louis University School of Medicine, St Louis, MO, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Department of Dermatology, Baylor University Medical Center, Dallas, TX, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tuttle', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morgan-Cox', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Edson-Heredia', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.17628']
3060,32043072,"Effects of selenium supplementation on glucose homeostasis in women with gestational diabetes mellitus: A randomized, controlled trial.","Background


There is limited evidence about the anti-diabetic effects of selenium supplementation in women with gestational diabetes mellitus (GDM).
Objective


This study investigates the effects of selenium supplementation on glucose homeostasis in women with GDM.
Materials and Methods


A total of 60 pregnant women with GDM were enrolled in this prospective randomized, double-blind, and placebo-controlled clinical trial. They were randomly assigned to take either 100µg selenium supplements as tablet or a placebo daily for 12 wk since 24-28 wk of gestation. The primary outcomes were changes in the glucose homeostasis, including fasting plasma glucose, the 2-hr post prandial blood glucose, serum insulin level, glycosylated hemoglobin (Hb A1C), and the homeostasis model assessment of insulin resistance(HOMA_IR) at the initial period and 3 months after intervention.
Results


The mean maternal age of the patients who took selenium supplements was 29.19  ±  6.16 (range 18-41) years. In the placebo group, the mean maternal age was 31  ±  4.43 (range 24-39) years. Compared with the placebo group, fasting plasma glucose, 2-hr post-prandial blood glucose, glycosylated hemoglobin(Hb A1C), serum insulin level, and homeostasis model of assessment-estimated insulin resistance(HOMA_IR) were not significantly changed in the selenium group at the end of study (p = 0.25, p = 0.87, p = 0.34, p = 0.57, and p = 0.31, respectively).
Conclusion


The results of this trial suggest that supplementation with 100µg of selenium does not modulate glucose homeostasis in women with GDM.",2019,"Compared with the placebo group, fasting plasma glucose, 2-hr post-prandial blood glucose, glycosylated hemoglobin(Hb A1C), serum insulin level, and homeostasis model of assessment-estimated insulin resistance(HOMA_IR) were not significantly changed in the selenium group at the end of study (p = 0.25, p = 0.87, p = 0.34, p = 0.57, and p = 0.31, respectively).
","['mean maternal age of the patients who took selenium supplements was 29.19  ±  6.16 (range 18-41) years', 'women with GDM.\nMaterials and Methods\n\n\nA total of 60 pregnant women with GDM', 'women with gestational diabetes mellitus (GDM', 'women with GDM', 'women with gestational diabetes mellitus']","['100µg selenium supplements as tablet or a placebo', 'placebo', 'selenium supplementation']","['fasting plasma glucose, 2-hr post-prandial blood glucose, glycosylated hemoglobin(Hb A1C), serum insulin level, and homeostasis model of assessment-estimated insulin resistance(HOMA_IR', 'glucose homeostasis, including fasting plasma glucose, the 2-hr post prandial blood glucose, serum insulin level, glycosylated hemoglobin (Hb A1C), and the homeostasis model assessment of insulin resistance(HOMA_IR', 'glucose homeostasis']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0521939', 'cui_str': 'Selenium supplement'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0521939', 'cui_str': 'Selenium supplement'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}]",60.0,0.485743,"Compared with the placebo group, fasting plasma glucose, 2-hr post-prandial blood glucose, glycosylated hemoglobin(Hb A1C), serum insulin level, and homeostasis model of assessment-estimated insulin resistance(HOMA_IR) were not significantly changed in the selenium group at the end of study (p = 0.25, p = 0.87, p = 0.34, p = 0.57, and p = 0.31, respectively).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sadat Najib', 'Affiliation': 'Infertility Research Centere of Obstetrics and Gynecology Ward, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Poordast', 'Affiliation': 'Infertility Research Centere of Obstetrics and Gynecology Ward, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Rezvan Nia', 'Affiliation': 'Infertility Research Centere of Obstetrics and Gynecology Ward, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossein Dabbaghmanesh', 'Affiliation': 'Endocrin and Metabolic Research center of Internal Medicine Ward, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i1.6201']
3061,32014427,"Letter to the Editor Regarding: ""Assessment of Valeriana officinalis (Valerian) for Conscious Sedation of Patients During the Extraction of Impacted Mandibular Third Molars: A Randomized, Split-Mouth, Double-Blind, Crossover Study"".",,2020,,['Conscious Sedation of Patients During the Extraction of Impacted Mandibular Third Molars'],['Valeriana officinalis (Valerian'],[],"[{'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0042281', 'cui_str': 'Valeriana'}]",[],,0.235735,,"[{'ForeName': 'Dimitar Vaskov', 'Initials': 'DV', 'LastName': 'Bakalov', 'Affiliation': 'Sofia, Bulgaria.'}, {'ForeName': 'Zafer Ahmed', 'Initials': 'ZA', 'LastName': 'Sabit', 'Affiliation': 'Sofia, Bulgaria.'}, {'ForeName': 'Radka Kirilova', 'Initials': 'RK', 'LastName': 'Tafradjiiska-Hadjiolova', 'Affiliation': 'Sofia, Bulgaria.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.12.029']
3062,32028982,"What is the effect of spinal manipulation on the pressure pain threshold in young, asymptomatic subjects? A randomized placebo-controlled trial, with a cross-over design.","BACKGROUND


Spinal manipulation (SM) has been shown to have an effect on the pressure pain threshold (PPT) in asymptomatic subjects, but SM has never been compared in studies on this topic to a validated sham procedure. We investigated the effect of SM on the PPT when measured i) in the area of intervention and ii) in an area remote from the intervention. In addition, we measured the size and duration of the effect.
METHOD


In a randomized cross-over trial, 50 asymptomatic chiropractic students had their PPT measured at baseline, immediately after and every 12 min after intervention, over a period of 45 min, comparing values after SM and a previously validated sham. The trial was conducted during two sessions, separated by 48 h. PPT was measured both regionally and remotely from the 'treated' thoracic segment. Blinding of study subjects was tested with a post-intervention questionnaire. We used mixed linear regression with the baseline value and time as co-variates. If a significant difference were found between groups, then an effect size would be calculated using Cohen's d or Hedge's h coefficient. Statistical significance was set at p < 0.05.
RESULTS


Study subjects had been successfully blinded. No statistically significant differences were found between SM and sham estimates, at any time or anatomical location.
CONCLUSION


When compared to a valid sham procedure and with successfully blinded subjects, there is no regional or remote effect of spinal manipulation of the thoracic spine on the pressure pain threshold in a young pain-free population.",2020,"When compared to a valid sham procedure and with successfully blinded subjects, there is no regional or remote effect of spinal manipulation of the thoracic spine on the pressure pain threshold in a young pain-free population.","['50 asymptomatic chiropractic students', 'young, asymptomatic subjects']","['Spinal manipulation (SM', 'spinal manipulation', 'placebo', 'SM']",['size and duration of the effect'],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",50.0,0.202648,"When compared to a valid sham procedure and with successfully blinded subjects, there is no regional or remote effect of spinal manipulation of the thoracic spine on the pressure pain threshold in a young pain-free population.","[{'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Honoré', 'Affiliation': 'CIAMS, University of Paris-Sud, University of Paris-Saclay, F-91405, Orsay Cedex, France. honore.margaux@ifecetud.net.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Picchiottino', 'Affiliation': 'CIAMS, University of Paris-Sud, University of Paris-Saclay, F-91405, Orsay Cedex, France.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Wedderkopp', 'Affiliation': 'Institute for Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'CIAMS, University of Paris-Sud, University of Paris-Saclay, F-91405, Orsay Cedex, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gagey', 'Affiliation': 'CIAMS, University of Paris-Sud, University of Paris-Saclay, F-91405, Orsay Cedex, France.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-0296-1']
3063,32036471,Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients.,"PURPOSE


This randomized phase II study was conducted to investigate the efficacy of cryotherapy in preventing peripheral neuropathy and dermatological adverse events in breast cancer patients treated with weekly paclitaxel.
METHODS


Patients treated with 12 weekly doses of paclitaxel for breast cancer were randomized (1:1) into a cryotherapy or control group. The primary endpoint was the percentage of patients with a marked decrease in the Functional Assessment of Cancer Therapy-Neurotoxicity (FACT-NTX) score. The secondary endpoints were Patient Neurotoxicity Questionnaire (PNQ), Common Terminology Criteria for Adverse Event (CTCAE) for peripheral neuropathy, and FACT-Taxane score.
RESULTS


Forty-four patients were randomly assigned to the cryotherapy (n = 22) or control groups (n = 22). The percentage of patients with a marked decrease in FACT-NTX scores was significantly lower in the cryotherapy group than in the control group (41 vs. 73%, p = 0.03). The incidence of CTCAE grade ≥ 2 sensory (p = 0.001) and motor peripheral neuropathy (p = 0.01), and PNQ grade D or higher for sensory peripheral neuropathy (p = 0.02), and decrease in the FACT-Taxane score (p = 0.02) were also significantly lower in the cryotherapy group than in the control group. There were no serious side effects associated with cryotherapy.
CONCLUSION


Cryotherapy is an effective approach for prevention of peripheral neuropathy and dermatological adverse events in breast cancer patients treated with weekly paclitaxel.",2020,"The percentage of patients with a marked decrease in FACT-NTX scores was significantly lower in the cryotherapy group than in the control group (41 vs. 73%, p = 0.03).","['breast cancer patients treated with weekly paclitaxel', 'Patients treated with 12 weekly doses of', 'for breast cancer', 'breast cancer patients treated with weekly', 'Forty-four patients', 'breast cancer patients']","['paclitaxel', 'cryotherapy or control group', 'Cryotherapy', 'cryotherapy']","['Functional Assessment of Cancer Therapy-Neurotoxicity', 'peripheral adverse events', 'incidence of CTCAE grade ≥\u20092 sensory', 'FACT-Taxane score', 'Patient Neurotoxicity Questionnaire (PNQ), Common Terminology Criteria for Adverse Event', 'PNQ grade D or higher for sensory peripheral neuropathy', 'motor peripheral neuropathy', 'FACT-NTX scores', 'peripheral neuropathy and dermatological adverse events']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1516728', 'cui_str': 'CTCAE (Common Terminology Criteria for Adverse Events)'}, {'cui': 'C0441808', 'cui_str': 'Grade D (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0235025', 'cui_str': 'Neuritis, Motor'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}]",44.0,0.0198073,"The percentage of patients with a marked decrease in FACT-NTX scores was significantly lower in the cryotherapy group than in the control group (41 vs. 73%, p = 0.03).","[{'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan. shigematu1330@yahoo.co.jp.'}, {'ForeName': 'Taizo', 'Initials': 'T', 'LastName': 'Hirata', 'Affiliation': 'Department of Medical Oncology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Aoyama-cho, Kure City, Hiroshima, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Nishina', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yasui', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ozaki', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05345-9']
3064,32043070,Effect of oral Utrogestan in comparison with Cetrotide on preventing luteinizing hormone surge in IVF cycles: A randomized controlled trial.,"Background


Oral progesterone is recommended as an alternative to gonadotropin-releasing hormone (GnRH) agonists and antagonists to prevent luteinizing hormone (LH) surge in assisted reproductive technology (ART) cycles. However, there are little data regarding its use.
Objective


We aimed to compare the effect of oral Utrogestan and Cetrotide (a GnRH antagonist) on preventing LH surge in ART cycles.
Materials and Methods


In this randomized clinical trial, 100 infertile women undergoing ART who received recombinant follicle-stimulating hormone (FSH) at 150-225 IU/day were randomly assigned to receive either Utrogestan 100 mg twice a day (case group) or GnRH antagonist protocol (control group) from cycle day 3 until the trigger day. Triggering was performed with 10,000 IU hCG) when there were at least three mature follicles. Viable embryos were cryopreserved for transfer in the next cycle for both groups. The number of oocytes retrieved and transferred embryos were compared between groups.
Results


The case group had significantly higher progesterone levels on triggering day, more follicles of  >  14 mm with higher maturity, and more oocytes retrieved with a higher rate of embryos transferred. A small increase in the pregnancy rate was observed in the case group, with no significant between-group differences. The most important result was the lack of premature LH surge in either group upon serum LH assessment on the triggering day.
Conclusion


Utrogestan is an alternative treatment that could reduce the LH surge rate and increase the ART outcomes including the number of oocytes retrieved and transferred embryos compared with GnRH agonists and antagonists.",2019,"The case group had significantly higher progesterone levels on triggering day, more follicles of  >  14 mm with higher maturity, and more oocytes retrieved with a higher rate of embryos transferred.","['IVF cycles', '100 infertile women undergoing ART who received']","['Cetrotide', 'Utrogestan 100 mg twice a day (case group) or GnRH antagonist protocol (control group', 'recombinant follicle-stimulating hormone (FSH', 'oral Utrogestan', 'oral Utrogestan and Cetrotide (a GnRH antagonist']","['LH surge', 'number of oocytes retrieved and transferred embryos', 'pregnancy rate', 'luteinizing hormone surge', 'progesterone levels', 'LH surge rate']","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0939290', 'cui_str': 'Cetrotide'}, {'cui': 'C1515400', 'cui_str': 'Utrogestan'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}]",100.0,0.131195,"The case group had significantly higher progesterone levels on triggering day, more follicles of  >  14 mm with higher maturity, and more oocytes retrieved with a higher rate of embryos transferred.","[{'ForeName': 'Alieh', 'Initials': 'A', 'LastName': 'Ghasemzadeh', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Dopour Faliz', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Farzadi', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Navali', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Bahramzadeh', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Fadavi', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Hakimi', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Tehrani-Ghadim', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Abdollahi Fard', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Hamdi', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v18i1.6197']
3065,31562765,"The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot, Randomized, Controlled Trial.","INTRODUCTION


This trial investigated whether a Facebook smoking cessation intervention culturally tailored to young sexual and gender minority (SGM) smokers (versus non-tailored) would increase smoking abstinence.
METHODS


Participants were 165 SGM young adult US smokers (age 18-25) recruited from Facebook in April 2018 and randomized to an SGM-tailored (POP; N = 84) or non-tailored (TSP-SGM; N = 81) intervention. Interventions delivered weekly live counseling sessions and 90 daily Facebook posts to participants in Facebook groups. Primary analyses compared POP and TSP-SGM on biochemically verified smoking abstinence (yes/no; primary outcome), self-reported 7-day point prevalence abstinence (yes/no), reduction in cigarettes per week by 50+% from baseline (yes/no), making a quit attempt during treatment (yes/no), and stage of change (precontemplation/contemplation vs. preparation/action). Supplemental analyses compared POP to two historical control groups.
RESULTS


POP participants were more likely than TSP-SGM participants to report smoking abstinence at 3 (23.8% vs. 12.3%; OR = 2.50; p = .03) and 6 months (34.5% vs. 12.3%; OR = 4.06; p < .001) and reduction in smoking at 3 months (52.4% vs. 39.5%; OR = 2.11; p = .03). Biochemically verified smoking abstinence did not significantly differ between POP and TSP-SGM at 3 (OR = 2.00; p = .33) or 6 months (OR = 3.12; p = .08), potentially due to challenges with remote biochemical verification. In supplemental analyses, POP participants were more likely to report abstinence at 3 (OR = 6.82, p = .01) and 6 (OR = 2.75, p = .03) months and reduced smoking at 3 months (OR = 2.72, p = .01) than participants who received a referral to Smokefree.gov.
CONCLUSIONS


This pilot study provides preliminary support for the effectiveness of a Facebook smoking cessation intervention tailored to SGM young adults.
IMPLICATIONS


SGM individuals have disproportionately high smoking prevalence. It is unclear whether smoking cessation interventions culturally tailored to the SGM community are more effective than non-tailored interventions. This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.
TRIAL REGISTRATION


NCT03259360.",2020,"This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.","['SGM young adults', 'Participants were 165 SGM young adult U.S. smokers (age 18-25) recruited from Facebook in April 2018 and randomized to an', 'Young Sexual and Gender Minority Smokers', 'Sexual and gender minority (SGM) individuals have disproportionately high smoking prevalence', 'young sexual and gender minority (SGM) smokers (versus non-tailored']","['live counseling sessions', 'Facebook smoking cessation intervention', 'SGM-tailored (POP; N=84) or non-tailored (TSP-SGM; N=81) intervention', 'SGM-tailored Facebook smoking cessation intervention', 'Facebook Intervention']","['self-reported 7-day point prevalence abstinence', 'POP and TSP-SGM on biochemically verified smoking abstinence', 'report abstinence', 'smoking abstinence']","[{'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0275547,"This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Humfleet', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz184']
3066,2183695,Felodipine as monotherapy in Asian patients with mild to moderate hypertension.,"Felodipine (Plendil) is a once daily antihypertensive calcium antagonist. The present study evaluated the clinical efficacy and tolerability of felodipine as monotherapy in treating Asian patients with mild to moderate hypertension. Twenty-three males and 14 females with supine diastolic blood pressure (sDBP) above 95 mmHg after a 2-4 week placebo treatment period were included in the study. Active treatment was initiated with felodipine 10 mg once every morning for 2 weeks. The dose was titrated stepwise with increments of 10 mg every two weeks if BP was greater than the target DBP of 90 mmHg. The optimum dose was then maintained for at least 4 months during which the patients returned for 2 weekly follow-up visits. At each visit, supine and standing blood pressure and heart rate (HR) were measured after dosing. Any adverse events were recorded when they occurred. Blood chemistry was checked before and at 4 weeks after starting felodipine treatment and at the end of the study. The target DBP was achieved in all 37 patients, 25 with 10 mg, 11 with 20 mg and 1 with 30 mg. The supine BP was reduced to 127 +/- 10/83 +/- 5 by felodipine which was significantly lower than the pre-treatment BP (151 +/- 16/103 +/- 8, p less than .001). The BP control was maintained at the end of the study period (124 +/- 12/82 +/- 6). No significant changes in heart rates were detected after felodipine treatment. Side effects attributable to vasodilation were observed in 10 patients (transient headache in 8 and mild ankle oedema in 2), none requiring withdrawal of the drug. We conclude that felodipine 10-20 mg given once daily is an effective and well-tolerated monotherapy for the treatment of mild to moderate hypertension.",1990,"Side effects attributable to vasodilation were observed in 10 patients (transient headache in 8 and mild ankle oedema in 2), none requiring withdrawal of the drug.","['Twenty-three males and 14 females with supine diastolic blood pressure (sDBP) above 95 mmHg after a 2-4 week placebo treatment period were included in the study', 'mild to moderate hypertension', '10 patients (transient headache in 8 and mild ankle oedema in 2), none requiring withdrawal of the drug', 'Asian patients with mild to moderate hypertension']","['felodipine', 'Felodipine (Plendil', 'Felodipine']","['supine BP', 'Blood chemistry', 'heart rates', 'adverse events', 'target DBP', 'supine and standing blood pressure and heart rate (HR', 'clinical efficacy and tolerability', 'BP control']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0235439', 'cui_str': 'Swollen ankle (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C0015772', 'cui_str': 'Felodipine'}, {'cui': 'C0700021', 'cui_str': 'Plendil'}]","[{'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0580945', 'cui_str': 'Standing blood pressure'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0206608,"Side effects attributable to vasodilation were observed in 10 patients (transient headache in 8 and mild ankle oedema in 2), none requiring withdrawal of the drug.","[{'ForeName': 'B Y', 'Initials': 'BY', 'LastName': 'Woo', 'Affiliation': 'Department of Cardiology, Singapore General Hospital.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Yeoh', 'Affiliation': ''}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Tan', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3067,31521449,Comparison Between Efficacy of Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: A Randomized Clinical Trial.,"OBJECTIVES


We evaluated the efficacy and safety of oral melatonin compared with oral diazepam for prevention of recurrent simple febrile seizures.
METHODS


This prospective randomized clinical trial included 60 children aged six to 50 months with recurrent simple febrile seizures who attended the pediatric neurology clinic in Tanta University Hospital. Children were randomly allocated into two groups: the first group (30 children) received oral melatonin 0.3 mg/kg/8 hours, whereas the other group (30 children) received oral diazepam 1 mg/kg/day divided into three doses. Both melatonin and diazepam were given only during the febrile illness, started at the onset of the fever for 48 to 72 hours. Patients were followed up for six months. The primary outcome was recurrence of febrile seizures and the secondary outcome was occurrence of adverse effect related to melatonin or diazepam.
RESULTS


The recurrence rate of febrile seizures was 17% (5/30) in the melatonin group and 37% (11/30) in the diazepam group. There was no significant difference between the two groups (P = 0.08) (95% confidence interval -0.025 to 0.42). Both melatonin and diazepam have significantly reduced recurrence of febrile seizures (P < 0.001). Adverse effects were reported in 13.3% and 23.3% of the children taking melatonin and diazepam, respectively. No serious side effects were reported with melatonin use. Sedation and dizziness were the main side effects reported in children receiving oral diazepam.
CONCLUSIONS


Our data suggest that melatonin, administered at the onset of a febrile illness, may effectively reduce the likelihood of recurrent simple febrile seizures. No serious side effects were encountered.",2019,"Adverse effects were reported in 13.3% and 23.3% of the children taking melatonin and diazepam, respectively.","['60 children aged six to 50\xa0months with recurrent simple febrile seizures who attended the Pediatric Neurology Clinic in Tanta University Hospital', 'Recurrent Simple Febrile Seizures']","['melatonin and diazepam', 'Melatonin and Diazepam', 'oral diazepam', 'oral melatonin', 'oral melatonin 0.3\xa0mg/kg/8\xa0hours', 'melatonin', 'diazepam']","['recurrence rate of febrile seizures', 'efficacy and safety', 'Sedation and dizziness', 'occurrence of adverse effect related to melatonin or diazepam', 'recurrence of febrile seizures', 'Adverse effects', 'serious side effects', 'febrile illness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0149886', 'cui_str': 'Seizure, Febrile, Simple'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3715202', 'cui_str': 'Pediatric neurology clinic'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1128801', 'cui_str': 'Melatonin 0.3 MG'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009952', 'cui_str': 'Fever Seizure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0743841', 'cui_str': 'Febrile syndrome'}]",60.0,0.244341,"Adverse effects were reported in 13.3% and 23.3% of the children taking melatonin and diazepam, respectively.","[{'ForeName': 'Mohammad Sami', 'Initials': 'MS', 'LastName': 'Barghout', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, Tanta University Hospital, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Azza Kamal', 'Initials': 'AK', 'LastName': 'Al-Shahawy', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, Pediatric Neurology Unit, Tanta University Hospital, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Doaa Mohamed', 'Initials': 'DM', 'LastName': 'El Amrousy', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, Pediatric Cardiology Unit, Tanta University Hospital, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amira Hamed', 'Initials': 'AH', 'LastName': 'Darwish', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, Pediatric Neurology Unit, Tanta University Hospital, Tanta University, Tanta, Egypt. Electronic address: amira.darwish@med.tanta.edu.eg.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2019.01.010']
3068,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3069,32044268,Prospective double-blinded randomized controlled trial of Microwave versus RadioFrequency Ablation for hepatocellular carcinoma (McRFA trial).,"BACKGROUND


Microwave (MWA) and radiofrequency ablation are the commonly used local ablation for hepatocellular carcinoma (HCC). Studies comparing both techniques are scarce. The aim of this study was to compare the efficacy of MWA versus RFA as a treatment for HCC.
METHODS


Patients with HCC who were suitable for local ablation were randomized into MWA or RFA. All patients were followed up regularly with contrast-enhanced computed tomography (CT) performed at 1, 3, 6 and 12 months after ablation. Both patients and the radiologists who interpreted the post-procedure CT scans were blinded to the treatment allocation. Treatment-related morbidity, overall and disease-free survivals were analyzed.
RESULTS


A total of 93 patients were recruited. Among them, 47 and 46 patients were randomized to MWA and RFA respectively. Patients in two groups were comparable in baseline demographics and tumor characteristics. With a median follow-up of around 30 months, there were no significant difference in the treatment-related morbidity, overall and disease-free survivals. MWA had a significantly shorter overall ablation time when compared with RFA (12 min vs 24 min, p < 0.001).
CONCLUSIONS


MWA is no different to RFA with respect to completeness of ablation and survivals. It is, however, as safe and effective as RFA in treating small HCC.",2020,"MWA had a significantly shorter overall ablation time when compared with RFA (12 min vs 24 min, p < 0.001).
","['A total of 93 patients were recruited', 'hepatocellular carcinoma (McRFA trial', 'hepatocellular carcinoma (HCC', 'Among them, 47 and 46 patients', 'Patients with HCC who were suitable for local ablation']","['MWA versus RFA', 'Microwave versus RadioFrequency Ablation', 'MWA', 'MWA or RFA', 'Microwave (MWA) and radiofrequency ablation']","['Treatment-related morbidity, overall and disease-free survivals', 'overall ablation time', 'treatment-related morbidity, overall and disease-free survivals']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0026051', 'cui_str': 'Microwaves'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",93.0,0.104477,"MWA had a significantly shorter overall ablation time when compared with RFA (12 min vs 24 min, p < 0.001).
","[{'ForeName': 'Charing C N', 'Initials': 'CCN', 'LastName': 'Chong', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong. Electronic address: chongcn@surgery.cuhk.edu.hk.'}, {'ForeName': 'Kit F', 'Initials': 'KF', 'LastName': 'Lee', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sunny Y S', 'Initials': 'SYS', 'LastName': 'Cheung', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Clement C M', 'Initials': 'CCM', 'LastName': 'Chu', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Anthony K W', 'Initials': 'AKW', 'LastName': 'Fong', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Joyce W Y', 'Initials': 'JWY', 'LastName': 'Hui', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Andrew K Y', 'Initials': 'AKY', 'LastName': 'Fung', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Hon T', 'Initials': 'HT', 'LastName': 'Lok', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Eugene Y J', 'Initials': 'EYJ', 'LastName': 'Lo', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Simon C H', 'Initials': 'SCH', 'LastName': 'Yu', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kelvin K C', 'Initials': 'KKC', 'LastName': 'Ng', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Paul B S', 'Initials': 'PBS', 'LastName': 'Lai', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2020.01.008']
3070,31479068,"Effects of open-label placebo on pain, functional disability, and spine mobility in patients with chronic back pain: a randomized controlled trial.","Chronic back pain (CBP) is a major global health problem, while its treatment is hampered by a lack of efficacy and restricted safety profile of common frontline therapies. The present trial aims to determine whether a 3-week open-label placebo treatment reduces pain intensity and subjective and objective functional disability in patients with CBP. This randomized controlled trial, following a pretest-posttest design, enrolled 127 patients with CBP (pain duration >12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany. Patients randomized to the open-label placebo group received a 3-week open-label placebo treatment. Patients in the treatment as usual (TAU) group received no intervention. Both groups continued TAU. Primary outcome was the change in pain intensity. Secondary outcomes included patient-reported functional disability and objective measures of spine mobility and depression, anxiety, and stress. One hundred twenty two patients with CBP were randomized to the open-label placebo group (N = 63) or TAU group (N = 59). Open-label placebo application led to a larger reduction of pain intensity (-0.62 ± 0.23 vs 0.11 ± 0.17, all M ± SE, P = 0.001, d = -0.44) as well as patient-reported functional disability (3.21 ± 1.59 vs 0.65 ± 1.15, P = 0.020, d = -0.45) and depression scores (-1.07 ± 0.55 vs 0.37 ± 0.39, P = 0.010, d = -0.50) compared with TAU only. Open-label placebo treatment did not affect objective mobility parameters, anxiety and stress. Our study demonstrates that a 3-week open-label placebo treatment is safe, well tolerated and reduces pain, disability, and depressive symptoms in CBP. Trial registration: German Clinical Trials Register, DRKS00012712.",2019,"Open-label placebo application led to a larger reduction of pain intensity (-0.62±0.23 vs. 0.11±0.17, all M ± SE, p=.001, d=-0.44) as well as patient-reported functional disability (3.21±1.59 vs. 0.65±1.15, p=.020, d=-0.45) and depression scores (-1.07±0.55 vs. 0.37±0.39, p=.010, d=-0.50) compared to treatment as usual only.","['chronic back pain patients', '122 chronic back pain patients', 'chronic back pain', 'enrolled 127 chronic back pain patients (pain duration > 12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany']","['3-week open-label placebo treatment', 'Open-label placebo', 'open-label placebo', 'OLP']","['pain intensity, and subjective and objective functional disability', 'pain intensity', 'safe, well tolerated and reduces pain, disability and depressive symptoms', 'objective mobility parameters, anxiety and stress', 'change in pain intensity', 'patient-reported functional disability, objective measures of spine mobility and depression, anxiety and stress', 'functional disability', 'depression scores', 'pain, functional disability and spine mobility']","[{'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1286140', 'cui_str': 'Measure of spine'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}]",127.0,0.298589,"Open-label placebo application led to a larger reduction of pain intensity (-0.62±0.23 vs. 0.11±0.17, all M ± SE, p=.001, d=-0.44) as well as patient-reported functional disability (3.21±1.59 vs. 0.65±1.15, p=.020, d=-0.45) and depression scores (-1.07±0.55 vs. 0.37±0.39, p=.010, d=-0.50) compared to treatment as usual only.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Kleine-Borgmann', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hellmann', 'Affiliation': ''}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001683']
3071,31570296,Efficacy and Safety of Dichlorphenamide for Primary Periodic Paralysis in Adolescents Compared With Adults.,"BACKGROUND


Primary periodic paralyses are rare, hereditary skeletal muscle diseases characterized by episodic muscle weakness. Dichlorphenamide was effective and well tolerated in two studies, including one with adolescents. This analysis describes effects of dichlorphenamide among adolescents and adults.
METHODS


Patients with primary periodic paralyses in a double-blind, controlled, crossover study were randomized to dichlorphenamide or placebo for nine weeks, with a nine-week or longer between-treatment washout period. Attack rate and severity-weighted attack rate during the final eight weeks of each treatment phase were calculated for adolescents and adults separately.
RESULTS


Seven adolescents (10 to ≤17 years) and 66 adults were enrolled; five of seven adolescents were evaluable for efficacy and six for safety. Dichlorphenamide total daily dosing among adolescents was 50 mg (n = 1) or 100 mg (n = 5), and in adults was 105.7 mg (mean; n = 61). In adolescents, the median decrease from baseline in frequency of weekly attacks was greater with dichlorphenamide (-0.96) than with placebo (-0.57), similar to findings in adults (dichlorphenamide, -0.83; placebo, -0.24). Severity-weighted attack frequency was likewise reduced more with dichlorphenamide than with placebo in adolescents and adults. The most common adverse event with dichlorphenamide in adolescents was skin rash (two of six [33%]). In adults, numbness was the most common adverse event (26 of 54 [48%]); skin rash occurred less frequently (10 of 54 [19%]).
CONCLUSIONS


Dichlorphenamide was comparably effective and tolerated among a small number of adolescents as well as adults, although types of adverse events differed between groups.",2019,"In adults, numbness was the most common adverse event (26 of 54 [48%]); skin rash occurred less frequently (10 of 54 [19%]).
","['Adolescents', 'Seven adolescents (10 to ≤17\xa0years) and 66 adults were enrolled; five of seven adolescents', 'Patients with primary periodic paralyses in a double-blind', 'adolescents and adults']","['dichlorphenamide', 'placebo', 'Dichlorphenamide', 'dichlorphenamide or placebo']","['frequency of weekly attacks', 'skin rash', 'effective and tolerated', 'effective and well tolerated', 'Efficacy and Safety', 'Attack rate and severity-weighted attack rate', 'Severity-weighted attack frequency']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1279412', 'cui_str': 'Periodic paralysis'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0012086', 'cui_str': 'diclofenamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",7.0,0.29476,"In adults, numbness was the most common adverse event (26 of 54 [48%]); skin rash occurred less frequently (10 of 54 [19%]).
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, New York. Electronic address: emma_ciafaloni@urmc.rochester.edu.'}, {'ForeName': 'Fredric', 'Initials': 'F', 'LastName': 'Cohen', 'Affiliation': 'Department of Global Development and Medical Affairs, Strongbridge Biopharma, Trevose, Pennsylvania.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Griggs', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, New York.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2019.07.019']
3072,32029429,Cervical versus endometrial injection for sentinel lymph node detection in endometrial cancer: a randomized clinical trial.,"OBJECTIVE


To evaluate the relationship between pelvic/para-aortic sentinel lymph node status and two different injection sites of 99m-technetium ( 99m Tc)-labeled phytate in patients with endometrial cancer.
METHODS


This was a randomized controlled trial involving 81 patients with endometrial cancer. In the cervical group (n=40), injections of  99m Tc were performed at the 3 and 9 o'clock positions of the uterine cervix. In the endometrial group (n=41),  99m Tc was injected into the fundal endometrium using a transcervical catheter. Sentinel lymph nodes were detected through pre-operative lymphoscintigraphy and intra-operatively using a handheld gamma probe. All patients underwent complete pelvic and para-aortic lymphadenectomy procedures. Pathologic ultra-staging was performed with immunostaining for cytokeratin in sentinel lymph nodes after routine hematoxylin and eosin histological examinations. The primary endpoint was the estimation of detection rates, sensitivity, false-negative rates, negative predictive value, and analysis of the distribution of pelvic and para-aortic sentinel lymph nodes.
RESULTS


The rate of detection of at least one sentinel lymph node, sensitivity, and the negative predictive value was 80%, 66.6%, 96.6% for the cervical group and 85%, 66.6%, 96.9% for the endometrial group, respectively. False-negative sentinel lymph nodes were detected in one patient from each group . There was no significant difference between the groups in terms of total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count was significantly higher in the endometrial group (p<0.001). Ultra-staging examination of the pelvic sentinel lymph nodes revealed isolated tumor cells in one patient from each group.
CONCLUSION


Transcervical endometrial tracer injection in endometrial cancer revealed similar pelvic but significantly higher para-aortic sentinel lymph node detection.",2020,"There was no significant difference between the groups in terms of total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count was significantly higher in the endometrial group (p<0.001).","['endometrial cancer', 'All patients underwent complete pelvic and para-aortic lymphadenectomy procedures', '81 patients with endometrial cancer', 'patients with endometrial cancer']","['Transcervical endometrial tracer injection', '99m-technetium', 'Cervical versus endometrial injection']","['rate of detection of at least one sentinel lymph node, sensitivity, and the negative predictive value', 'estimation of detection rates, sensitivity, false-negative rates, negative predictive value, and analysis of the distribution of pelvic and para-aortic sentinel lymph nodes', 'False-negative sentinel lymph nodes', 'total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count']","[{'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0039411', 'cui_str': 'Technetium'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}]","[{'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205558', 'cui_str': 'False negative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}]",81.0,0.0473042,"There was no significant difference between the groups in terms of total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count was significantly higher in the endometrial group (p<0.001).","[{'ForeName': 'Şener', 'Initials': 'Ş', 'LastName': 'Gezer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli University School of Medicine, Kocaeli, Turkey dr.senergezer@gmail.com.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Duman Öztürk', 'Affiliation': 'Department of Pathology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Turkay', 'Initials': 'T', 'LastName': 'Hekimsoy', 'Affiliation': 'Department of Nuclear Medicine, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Çiğdem', 'Initials': 'Ç', 'LastName': 'Vural', 'Affiliation': 'Department of Pathology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'İşgören', 'Affiliation': 'Department of Nuclear Medicine, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'İzzet', 'Initials': 'İ', 'LastName': 'Yücesoy', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Çorakçı', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000860']
3073,32030508,"Abrogation of postprandial triglyceridemia with dual PPAR α/γ agonist in type 2 diabetes mellitus: a randomized, placebo-controlled study.","AIMS


Lowering postprandial lipemia may mitigate cardiovascular risk in patients with diabetic dyslipidemia. This study was aimed to investigate whether saroglitazar suppresses postprandial lipemia in patients with diabetes and dyslipidemia.
METHODS


This was a 12-week, prospective, multicenter, randomized, double-blinded, placebo-controlled study of saroglitazar in patients with diabetes and dyslipidemia. Thirty patients were randomized (1:1) to receive saroglitazar 4 mg or placebo orally once daily with metformin for 12 weeks. The primary endpoint was change in plasma triglyceride (TG) area under the curve (AUC) on a standardized 8-h fat tolerance test.
RESULTS


Thirty participants were randomized for interventions and eventually data of 19 participants qualified for per protocol analyses. Mean (SD) age in saroglitazar was 53.1 (8.8) years and 54.9 (7.7) years in placebo group. After 12 weeks, saroglitazar significantly lowered postprandial TG-AUC by - 458.3 (144.0) (- 25.7%, 95% CI - 765.1 to - 151.4) versus an increase of + 10.9 (157.9) (+ 0.5%, 95% CI - 325.6 to 347.3) mg/dL h in placebo group (P < 0.05). Saroglitazar lowered postprandial TG incremental AUC versus placebo: - 329.4 (89.9) (- 59%) versus + 80.4 (99.4) (+ 10%) mg/dL h (P < 0.05). HbA1c (%) decreased by - 0.36 (0.42) in the saroglitazar group as compared to an increase of + 1.26 (0.46) (P < 0.05) with placebo.
CONCLUSIONS


The saroglitazar treatment significantly improved postprandial TGs in people with diabetic dyslipidemia.
TRIAL REGISTRATION


Clinical Trial Registry of India; trial Registration No.: CTRI/2015/06/005845 and Date of registration: June 02, 2015.",2020,"HbA1c (%) decreased by - 0.36 (0.42) in the saroglitazar group as compared to an increase of + 1.26 (0.46) (P < 0.05) with placebo.
","['patients with diabetic dyslipidemia', 'people with diabetic dyslipidemia', 'patients with diabetes and dyslipidemia', 'type 2 diabetes mellitus', 'Thirty participants', 'Thirty patients']","['postprandial triglyceridemia with dual PPAR α/γ agonist', 'saroglitazar 4\xa0mg or placebo orally once daily with metformin', 'placebo', 'saroglitazar']","['postprandial TG-AUC', 'postprandial TGs', 'Mean (SD) age in saroglitazar', 'change in plasma triglyceride (TG) area under the curve (AUC) on a standardized 8-h fat tolerance test', 'postprandial TG incremental AUC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160761', 'cui_str': 'Diabetic dyslipidaemia'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3852920'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3852920'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0430156', 'cui_str': 'Fat tolerance test (procedure)'}]",30.0,0.749475,"HbA1c (%) decreased by - 0.36 (0.42) in the saroglitazar group as compared to an increase of + 1.26 (0.46) (P < 0.05) with placebo.
","[{'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Dunbar', 'Affiliation': 'Cardiometabolic and Lipid Clinic, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Hemant P', 'Initials': 'HP', 'LastName': 'Thacker', 'Affiliation': 'Bhatia Hospital, G-1 Block, Tardeo Road, Mumbai, Maharashtra, 400007, India.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Bhatt', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, Gujarat, 382210, India.'}, {'ForeName': 'Krupi', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, Gujarat, 382210, India.'}, {'ForeName': 'Deven V', 'Initials': 'DV', 'LastName': 'Parmar', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, Gujarat, 382210, India. deven.parmar@zydusdiscovery.ae.'}]",Acta diabetologica,['10.1007/s00592-020-01487-8']
3074,1975478,Variation at the apolipoprotein (apo) AI-CIII-AIV gene cluster and apo B gene loci is associated with lipoprotein and apolipoprotein levels in Italian children.,"We have used RFLPs of the apolipoprotein (apo) B gene and apo AI-CIII-AIV gene cluster to estimate the genetic contribution of variation at these loci to the variability of plasmid lipid, lipoprotein, and apolipoprotein levels in 209 children from Sezze in central Italy. The sample was randomly divided into group I (107 children) and group II (102 children). Four site polymorphisms (PvuII, XbaI, MspI, and EcoRI) of the apo B gene and five site polymorphisms (XmnI, PstI, SstI, PvuII-CIII, and PvuII-AIV) of the apo AI-CIII-AIV gene cluster were examined in group I children. After adjustment for gender, age, and body-mass index, polymorphisms at both gene loci (PvuII-B, PvuII-CIII, and PvuII-AIV) were associated with significant effects on the levels of plasma apo AI, apo B, or high-density lipoprotein-cholesterol. RFLPs that showed significant effects in group I were genotyped in group II. All three polymorphisms were associated with similar effects on apolipoprotein levels, though for all RFLPs the magnitude of the effects was smaller in the group II children and only statistically significant for the effect of the PvuII-B genotype on apo AI levels. In the total sample of 209 children 7.4% of the sample variance in apo AI levels was explained by variation associated with the apo B PvuII-B RFLP. In addition, the PvuII-B RFLP was associated with significant effects on plasma apo B levels and explained 5.7% of the sample variance. The PvuII-CIII and PvuII-AIV polymorphisms were both associated with differences in apo AI levels, explaining 3.7%-5.7% of the sample variance. Taken together, the three PvuII polymorphisms explained 17.7% of the phenotypic variance in apo AI levels. There was significant evidence for an effect of nonlinearity of the PvuII-CIII genotypes on apo AI levels, with the individuals heterozygous for the polymorphism having the highest apo AI levels. No evidence of interaction between genotype and gender, age, and body-mass index was shown by covariance analysis. The molecular explanation of this effect is unclear. Our data show that variation at both the apo AI-CIII-AIV and apo B loci are associated with lipoprotein and apolipoprotein levels in this sample of Italian children.",1990,"There was significant evidence for an effect of nonlinearity of the PvuII-CIII genotypes on apo AI levels, with the individuals heterozygous for the polymorphism having the highest apo AI levels.","['209 children from Sezze in central Italy', 'Italian children']",[],"['lipoprotein and apolipoprotein levels', 'levels of plasma apo AI, apo B, or high-density lipoprotein-cholesterol', 'plasma apo B levels', 'PvuII-B genotype on apo AI levels', 'apo AI levels', 'apolipoprotein levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}]",[],"[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085201', 'cui_str': 'Apo AI'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]",209.0,0.0281642,"There was significant evidence for an effect of nonlinearity of the PvuII-CIII genotypes on apo AI levels, with the individuals heterozygous for the polymorphism having the highest apo AI levels.","[{'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Xu', 'Affiliation': 'Charing Cross Sunley Research Centre, Hammersmith, London, England.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Nanjee', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Savill', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Talmud', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Angelico', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Del Ben', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Antonini', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mazzarella', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Humphries', 'Affiliation': ''}]",American journal of human genetics,[]
3075,31491444,"Effect of different nap opportunity durations on short-term maximal performance, attention, feelings, muscle soreness, fatigue, stress and sleep.","The aim of the present study was to determine the effect of different nap opportunity durations on short-term maximal performance, attention, feelings, muscle soreness, fatigue, stress and sleep. Twenty physically active men (age: 21.1 ± 3.6 years, height: 176.4 ± 5.7 cm, body-mass: 72 ± 10.8 kg) performed the 5-jump and the digit-cancellation (i.e., attention) tests after four randomized nap opportunity conditions: no-nap opportunity (N0), 25 min of nap opportunity (N25), 35 min of nap opportunity (N35) and 45 min of nap opportunity (N45). Subjective measurement of feelings, muscle soreness, fatigue, stress and sleep were performed during each test session. Compared to N0, there was a significant improvement of the 5-jump performance during N35 (Δ = +3.5%, p < .01) and N45 (Δ = +3.7%, p < .01). Attention was also better after N45 compared to N0 (Δ = +7.5%, p < .05). Fatigue, sleep and stress scores were significantly lower after N25, N35 and N45 compared to N0 (p < .05). However, no-significant effect of naps durations on feelings and fatigue scores was observed. A nap opportunity has a beneficial effect on physical performance and attention with better results observed for naps ≥35 min.",2019,"Fatigue, sleep and stress scores were significantly lower after N25, N35 and N45 compared to N0 (p < .05).","['Twenty physically active men (age: 21.1\u202f±\u202f3.6\u202fyears, height: 176.4\u202f±\u202f5.7\u202fcm, body-mass: 72\u202f±\u202f10.8\u202fkg) performed the 5-jump and the digit-cancellation (i.e., attention) tests after four']","['randomized nap opportunity conditions: no-nap opportunity (N0), 25\u202fmin of nap opportunity (N25), 35\u202fmin of nap opportunity (N35) and 45\u202fmin of nap opportunity (N45']","['5-jump performance', 'Fatigue, sleep and stress scores', 'short-term maximal performance, attention, feelings, muscle soreness, fatigue, stress and sleep', 'naps durations on feelings and fatigue scores', 'Subjective measurement of feelings, muscle soreness, fatigue, stress and sleep']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",20.0,0.0220385,"Fatigue, sleep and stress scores were significantly lower after N25, N35 and N45 compared to N0 (p < .05).","[{'ForeName': 'Hsen', 'Initials': 'H', 'LastName': 'Hsouna', 'Affiliation': 'UR15JS01: Education, Motricity, Sport and Health (EM2S), High Institute of Sport and Physical Education, Sfax University, Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Boukhris', 'Affiliation': 'UR15JS01: Education, Motricity, Sport and Health (EM2S), High Institute of Sport and Physical Education, Sfax University, Tunisia.'}, {'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Abdessalem', 'Affiliation': 'UR15JS01: Education, Motricity, Sport and Health (EM2S), High Institute of Sport and Physical Education, Sfax University, Tunisia.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': ""UR15JS01: Education, Motricity, Sport and Health (EM2S), High Institute of Sport and Physical Education, Sfax University, Tunisia; Institut Supérieur du Sport et de l'éducation physique de Sfax, Université de Sfax, Tunisie.""}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, 39106 Magdeburg, Germany.'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'éducation physique de Sfax, Université de Sfax, Tunisie; Activité Physique, Sport et Santé, UR18JS01, Observatoire National du Sport, Tunis, Tunisie. Electronic address: h_chtourou@yahoo.fr.""}]",Physiology & behavior,['10.1016/j.physbeh.2019.112673']
3076,31860601,Deep neuromuscular blockade during spinal surgery reduces intra-operative blood loss: A randomised clinical trial.,"BACKGROUND


Spinal surgery is usually performed in the prone position using a posterior approach. However, the prone position may cause venous engorgement in the back and thus increase surgical bleeding with interruption of surgery. The prone position also affects cardiac output since large vessels are compressed decreasing venous return to the heart.
OBJECTIVE


We hypothesised that deep neuromuscular blockade would be associated with less surgical bleeding during spinal surgery in the prone position.
DESIGN


Randomised, single blinded trial.
SETTING


University teaching hospital.
PARTICIPANTS


Eighty-eight patients in two groups.
INTERVENTIONS


Patients were randomly assigned to moderate neuromuscular blockade or deep neuromuscular blockade. In the moderate neuromuscular blockade group, administration of rocuronium was adjusted such that the train-of-four count was one to two. In the deep neuromuscular blockade group, rocuronium administration was adjusted such that the train-of-four count was zero with a posttetanic count 2 or less.
MAIN OUTCOME MEASURES


The primary outcome was the volume of intra-operative surgical bleeding. The surgeon's satisfaction with operating conditions, haemodynamic and respiratory status, and postoperative pain scores were evaluated.
RESULTS


The median [IQR] volume of intra-operative surgical bleeding was significantly less in the deep neuromuscular blockade group than in the moderate neuromuscular blockade group; 300 ml [200 to 494] vs. 415 ml [240 to 601]; difference: 117 ml (95% CI, 9 to 244; P = 0.044). The mean ± SD surgeon's satisfaction with the intra-operative surgical conditions was greater in the deep neuromuscular blockade group than in the moderate neuromuscular blockade group; 3.5 ± 1.0 vs. 2.9 ± 0.9 (P = 0.004). In intergroup comparisons of respiratory variables, peak inspiratory pressure was lower in the deep neuromuscular blockade group overall (P < 0.001). The median [IQR] postoperative pain score was lower in the deep neuromuscular blockade group than the moderate neuromuscular blockade group; 50 [36 to 60] vs. 60 [50 to 70], (P = 0.023).
CONCLUSION


Deep neuromuscular blockade reduced intra-operative surgical bleeding in patients undergoing spinal surgery. This may be related to greater relaxation in the back muscles and lower intra-operative peak inspiratory pressure when compared with moderate neuromuscular blockade.
TRIAL REGISTRATION


KCT0001264 (http://cris.nih.go.kr).",2020,"The median [IQR] postoperative pain score was lower in the deep neuromuscular blockade group than the moderate neuromuscular blockade group; 50 [36 to 60] vs. 60 [50 to 70], (P = 0.023).
","['Eighty-eight patients in two groups', 'patients undergoing spinal surgery', 'University teaching hospital']","['spinal surgery', 'rocuronium', 'moderate neuromuscular blockade or deep neuromuscular blockade']","['median [IQR] volume of intra-operative surgical bleeding', 'intra-operative surgical bleeding', ""surgeon's satisfaction with operating conditions, haemodynamic and respiratory status, and postoperative pain scores"", ""mean\u200a±\u200aSD surgeon's satisfaction with the intra-operative surgical conditions"", 'volume of intra-operative surgical bleeding', 'median [IQR] postoperative pain score', 'surgical bleeding', 'peak inspiratory pressure', 'intra-operative blood loss']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",88.0,0.185799,"The median [IQR] postoperative pain score was lower in the deep neuromuscular blockade group than the moderate neuromuscular blockade group; 50 [36 to 60] vs. 60 [50 to 70], (P = 0.023).
","[{'ForeName': 'Woon-Seok', 'Initials': 'WS', 'LastName': 'Kang', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine (WS-K, CS-O, KYR, MHK, SH-K), Department of Orthopedic Surgery, Konkuk University Medical Center (TH-K, SHL), Department of Medicine, Institute of Biomedical Science and Technology (WS-K, CS-O, KYR, TH-K, SHL, SH-K) and Department of Infection and Immunology, Konkuk University School of Medicine, Seoul, South Korea (SH-K).'}, {'ForeName': 'Chung-Sik', 'Initials': 'CS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Ka Y', 'Initials': 'KY', 'LastName': 'Rhee', 'Affiliation': ''}, {'ForeName': 'Min H', 'Initials': 'MH', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Suk H', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Seong-Hyop', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001135']
3077,31689588,High-frequency rTMS over the supplementary motor area improves freezing of gait in Parkinson's disease: a randomized controlled trial.,"INTRODUCTION


Freezing of gait (FOG) contributes to falls in Parkinson's disease (PD), but robust, effective treatments remain elusive. There is evidence indicating that the supplementary motor area (SMA) plays an important role in the pathogenesis of FOG and may therefore be a potential neuromodulation target. The present study explored the clinical efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the SMA on FOG in PD patients.
METHODS


A group of 30 PD patients with FOG were enrolled in a randomized, double-blind, sham-controlled trial. Patients were randomly allocated 2:1 to receive ten sessions of either real (N = 20) or sham (N = 10) 10 Hz rTMS over SMA. The patients were assessed at baseline (T 0 ), after the 5th (T 1 ) and 10th (T 2 ) sessions, and then 2 weeks (T 3 ) and 4 weeks (T 4 ) after the last session. The primary clinical outcome was the Freezing of Gait Questionnaire score (FOGQ), with the Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor scores (MDS-UPDRS III) and Timed Up and Go test as secondary clinical outcomes. All the assessments were carried out at the ""ON"" state.
RESULTS


With a four week's follow-up, there were significant interaction effects in the FOGQ (effect of group*time, p = 0.04), MDS-UPDRS III (p = 0.02) and several gait variables (total duration, p < 0.01; cadence, p = 0.04; turn duration, p = 0.01; and turn to sit duration, p = 0.02). Post-hoc analyses revealed a significantly decreased FOGQ score at T 2  and T 4 , and significant improvements of MDS-UPDRS III and gait variables at T 1 , T 2 , T 3  and T 4  in the rTMS group. No significant improvements were found in the sham group.
CONCLUSION


High-frequency rTMS over SMA may ultimately serve as an add-on therapy for alleviating FOG in PD patients.",2019,"cadence, p = 0.04; turn duration, p = 0.01; and turn to sit duration, p = 0.02).","['PD patients', 'A group of 30 PD patients with FOG', ""Parkinson's disease""]","['high-frequency repetitive transcranial magnetic stimulation (rTMS', 'real (N\u202f=\u202f20) or sham (N\u202f=\u202f10) 10\u202fHz rTMS over SMA', 'Freezing of gait (FOG']","[""Freezing of Gait Questionnaire score (FOGQ), with the Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor scores (MDS-UPDRS III) and Timed Up and Go test as secondary clinical outcomes"", 'FOGQ score', 'MDS-UPDRS III', 'several gait variables (total duration', 'MDS-UPDRS III and gait variables']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0450030', 'cui_str': 'Fog'}]","[{'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0933072,"cadence, p = 0.04; turn duration, p = 0.01; and turn to sit duration, p = 0.02).","[{'ForeName': 'Tao-Mian', 'Initials': 'TM', 'LastName': 'Mi', 'Affiliation': ""National Clinical Research Center for Geriatric Disorders, Beijing, China; Department of Neurology, Neurobiology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute for Brain Disorders, Beijing, China; Pacific Parkinson's Research Centre, University of British Columbia, Vancouver, Canada.""}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ""Pacific Parkinson's Research Centre, University of British Columbia, Vancouver, Canada.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ba', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Ai-Ping', 'Initials': 'AP', 'LastName': 'Liu', 'Affiliation': 'University of Science and Technology of China, Hefei, Anhui, China. Electronic address: aipingl@ustc.edu.cn.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Neurobiology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute for Brain Disorders, Beijing, China.'}, {'ForeName': 'Lin-Lin', 'Initials': 'LL', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Neurobiology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute for Brain Disorders, Beijing, China.'}, {'ForeName': 'Xiao-Juan', 'Initials': 'XJ', 'LastName': 'Dan', 'Affiliation': 'Department of Neurology, Neurobiology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute for Brain Disorders, Beijing, China.'}, {'ForeName': 'Piu', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': ""National Clinical Research Center for Geriatric Disorders, Beijing, China; Department of Neurology, Neurobiology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute for Brain Disorders, Beijing, China; Clinical Center for Parkinson's Disease, Capital Medical University, Beijing, China; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Beijing, China. Electronic address: pbchan@hotmail.com.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'McKeown', 'Affiliation': ""Pacific Parkinson's Research Centre, University of British Columbia, Vancouver, Canada; Department of Medicine (Neurology), University of British Columbia, Vancouver, Canada.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.10.009']
3078,31575508,Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies.,"BACKGROUND


Benralizumab did not significantly reduce exacerbations compared with placebo in the phase 3 GALATHEA and TERRANOVA trials of benralizumab for patients with chronic obstructive pulmonary disease (COPD). We aimed to identify clinical and physiological characteristics of patients with COPD that could help to identify people who are likely to have the greatest treatment effect with benralizumab.
METHODS


We analysed individual study and pooled results from GALATHEA and TERRANOVA. At study enrolment, patients from GALATHEA and TERRANOVA were aged 40-85 years, had moderate to very severe airflow limitation, had elevated blood eosinophil counts, and at least two exacerbations or one severe exacerbation in the previous year despite dual inhaled therapy (inhaled corticosteroids plus long-acting β 2 -agonists or long-acting β 2 -agonists plus long-acting muscarinic antagonists) or triple inhaled therapy (inhaled corticosteroids plus long-acting β 2 -agonists plus long-acting muscarinic antagonists). We analysed data for 3910 patients who received benralizumab (30 mg or 100 mg subcutaneously every 8 weeks; first three doses every 4 weeks) or placebo with dual or triple therapy to identify factors consistently associated with annual exacerbation rate reduction. We evaluated the annual exacerbation rate for benralizumab versus placebo as the primary endpoint. GALATHEA and TERRANOVA are registered with ClinicalTrials.gov, NCT02138916 and NCT02155660, respectively.
FINDINGS


For 2665 patients with elevated blood eosinophil counts, treatment effect with benralizumab every 8 weeks at 100 mg, but not at 30 mg, occurred for patients with a history of more frequent exacerbations, poorer baseline lung function, or greater baseline lung function improvement with short-acting bronchodilators. Patients with baseline blood eosinophil counts of 220 cells per μL or greater with: three or more exacerbations in the previous year receiving benralizumab every 8 weeks versus placebo, had rate ratios (RRs) of 0·69 (95% CI 0·56-0·83) for 100 mg and 0·86 (0·71-1·04) for 30 mg; postbronchodilator FEV 1  of less than 40% had RRs of 0·76 (0·64-0·91) for 100 mg and 0·90 (0·76-1·06) for 30 mg; and postbronchodilator response of at least 15% had RRs of 0·67 (0·54-0·83) for 100 mg and 0·87 (0·71-1·07) for 30 mg. When combined factors were examined, patients with elevated baseline blood eosinophil counts, with three or more exacerbations in the previous year, and who were receiving triple therapy were identified as likely to benefit from benralizumab 100 mg every 8 weeks versus placebo (RR 0·70 [95% CI 0·56-0·88]). Benralizumab 30 mg every 8 weeks did not benefit patients meeting these criteria compared with placebo (RR 0·99 [95% CI 0·79-1·23]).
INTERPRETATION


Elevated blood eosinophil counts combined with clinical characteristics identified a subpopulation of patients with COPD who had reductions in exacerbations with benralizumab treatment. These hypothesis-generating analyses identified the potential efficacy of benralizumab 100 mg for this subpopulation. These findings require prospective evaluation in clinical trials.
FUNDING


AstraZeneca.",2020,"Benralizumab 30 mg every 8 weeks did not benefit patients meeting these criteria compared with placebo (RR 0·99 [95% CI 0·79-1·23]).
","['3910 patients who received', 'patients with COPD', 'chronic obstructive pulmonary disease', 'Patients with baseline blood eosinophil counts of 220 cells per μL or greater with: three or more exacerbations in the previous year receiving', 'patients from GALATHEA and TERRANOVA were aged 40-85 years, had moderate to very severe airflow limitation, had elevated blood eosinophil counts, and at least two exacerbations or one severe exacerbation in the previous year despite dual inhaled therapy (inhaled corticosteroids plus long-acting β 2 -agonists or long-acting β 2 -agonists plus long-acting muscarinic antagonists) or triple inhaled therapy (inhaled corticosteroids plus long-acting β 2 -agonists plus long-acting muscarinic antagonists', '2665 patients with', 'patients with chronic obstructive pulmonary disease (COPD']","['Benralizumab', 'benralizumab', 'placebo', 'benralizumab versus placebo', 'placebo with dual or triple therapy']","['annual exacerbation rate', 'rate ratios (RRs', 'elevated blood eosinophil counts', 'postbronchodilator response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4048185', 'cui_str': 'Genus Terranova'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0003385', 'cui_str': 'Antimuscarinic Agents'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}]","[{'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",2665.0,0.313604,"Benralizumab 30 mg every 8 weeks did not benefit patients meeting these criteria compared with placebo (RR 0·99 [95% CI 0·79-1·23]).
","[{'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA. Electronic address: gerard.criner@tuhs.temple.edu.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, Manchester University NHS Hospital Trust, Manchester, UK.'}, {'ForeName': 'Alvar', 'Initials': 'A', 'LastName': 'Agusti', 'Affiliation': ""Respiratory Institute, Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red Enfermedades Respiratorias, Barcelona, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jison', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makulova', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Vivian H', 'Initials': 'VH', 'LastName': 'Shih', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brooks', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Newbold', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30338-8']
3079,30615583,Randomized Controlled Trial of A 12-Week Yoga-Based (Including Diet) Lifestyle vs. Dietary Intervention on Cardio-Metabolic Risk Factors and Continuous Risk Score in Indian Adults with Metabolic Syndrome.,"Metabolic syndrome, a prediabetic and precardiovascular pathologic condition that begins early in life, tracks into adulthood and magnifies with age. Randomized controlled trials evaluating efficacy of yoga-based lifestyle vs. dietary intervention on metabolic syndrome are lacking. Here, the efficacy of a 12-week yoga-based lifestyle intervention vs. dietary intervention on cardio-metabolic risk factors and metabolic syndrome risk scores have been assessed in Indian adults with metabolic syndrome. In this two-arm, open label, parallel group, randomized controlled trial, 260 adults (20-45 years) diagnosed with metabolic syndrome as per joint interim statement, 2009 were randomized to yoga-based (including diet) lifestyle or dietary intervention alone (n = 130, each) for 12 weeks. Primary endpoints were the 12-week changes in cardio-metabolic risk factors and metabolic risk scores. The secondary endpoints were the 12-week changes in the proportion of subjects recovered from metabolic syndrome, dietary intake, and physical activity. Intent-to-treat analysis was performed including all the subjects with baseline data with imputed missing data. Treatment × time interaction showed yoga-based lifestyle intervention had a greater treatment effect over dietary intervention by significantly reducing waist circumference, continuous metabolic syndrome z-score, and dietary intake/day while significantly increasing physical activity. High-density lipoprotein cholesterol showed a significantly greater reduction following dietary intervention than yoga-based lifestyle intervention. A significantly greater proportion of subjects recovered from metabolic syndrome in yoga-based lifestyle (45.4%) vs. dietary intervention group (32.3%). A 12-week yoga-based lifestyle intervention is more efficacious than usual dietary intervention in improving cardio-metabolic risk factor and metabolic risk score in Indian adults with metabolic syndrome.",2020,A 12-week yoga-based lifestyle intervention is more efficacious than usual dietary intervention in improving cardio-metabolic risk factor and metabolic risk score in Indian adults with metabolic syndrome.,"['Indian adults with metabolic syndrome', 'Indian Adults with Metabolic Syndrome', '260 adults (20-45\u2009years) diagnosed with metabolic syndrome as per joint interim statement, 2009 were randomized to']","['12-Week Yoga-Based (Including Diet) Lifestyle vs. Dietary Intervention', 'yoga-based lifestyle vs. dietary intervention', 'yoga-based lifestyle intervention', 'yoga-based (including diet) lifestyle or dietary intervention alone', 'yoga-based lifestyle intervention vs. dietary intervention', 'usual dietary intervention']","['cardio-metabolic risk factors and metabolic risk scores', 'cardio-metabolic risk factor and metabolic risk score', 'Cardio-Metabolic Risk Factors and Continuous Risk Score', 'cardio-metabolic risk factors and metabolic syndrome risk scores', 'High-density lipoprotein cholesterol', 'waist circumference, continuous metabolic syndrome z-score, and dietary intake/day while significantly increasing physical activity', 'proportion of subjects recovered from metabolic syndrome, dietary intake, and physical activity']","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",260.0,0.0198599,A 12-week yoga-based lifestyle intervention is more efficacious than usual dietary intervention in improving cardio-metabolic risk factor and metabolic risk score in Indian adults with metabolic syndrome.,"[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Raj Kumar', 'Initials': 'RK', 'LastName': 'Yadav', 'Affiliation': 'Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khadgawat', 'Affiliation': 'Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Nalin', 'Initials': 'N', 'LastName': 'Mehta', 'Affiliation': 'Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2018.1538098']
3080,31602471,"Randomized controlled trial of OnTrack, a just-in-time adaptive intervention designed to enhance weight loss.","Individual instances of nonadherence to reduced calorie dietary prescriptions, that is, dietary lapses, represent a key challenge for weight management. Just-in-time adaptive interventions (JITAIs), which collect and analyze data in real time to deliver tailored interventions during moments of need, may be well suited to promote weight loss by preventing dietary lapses. We developed OnTrack (OT), a smartphone application (app) that collects data on lapses and triggers of lapse, uses a continuously improving machine learning model to predict lapse risk, and delivers tailored interventions when risk is elevated. The current study evaluated the efficacy of OT against an active control in facilitating weight loss. Participants (N = 181) with overweight/obesity (MBMI = 34.32; 85.1% female; 73.5% White) were randomized to receive either the WW (formerly Weight Watchers) Beyond the Scale (BTS) digital program alone or WW plus OnTrack (WW + OT) for 10 weeks. In an unplanned, natural experiment, the WW program changed mid-way through the trial from BTS to a more flexible one, Freestyle (FS). A general linear model revealed a treatment condition × diet plan interaction (F[1, 173] = 9.68, p = .002) such that OT demonstrated greater efficacy only among those receiving BTS (weight loss MWW + OT = 4.7%, standard error [SE] = .55 versus MWW = 2.6%, SE = .80). Compared to FS, BTS WW + OT participants also reported considerably higher satisfaction with the intervention, engagement was higher, and algorithm accuracy was superior. Overall, results offer qualified support for OT and generally for machine learning-powered JITAIs that facilitate weight loss by predicting and preventing dietary lapses.",2019,"Compared to FS, BTS WW + OT participants also reported considerably higher satisfaction with the intervention, engagement was higher, and algorithm accuracy was superior.",['Participants (N = 181) with overweight/obesity (MBMI = 34.32; 85.1% female; 73.5% White'],"['OT', 'FS, BTS WW + OT', 'Scale (BTS) digital program alone or WW plus OnTrack (WW + OT']",['weight loss'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0222045'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.017701,"Compared to FS, BTS WW + OT participants also reported considerably higher satisfaction with the intervention, engagement was higher, and algorithm accuracy was superior.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, USA.'}, {'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control & Diabetes Research Center, Warren Alpert Medical School of Brown University, Providence, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Crochiere', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, USA.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, USA.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Weight Watchers International, New York, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz137']
3081,31725942,"Randomized, double-blind, placebo-controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder.","AIM


The burden of major depressive disorder (MDD) in Japan is high. This study aimed to evaluate the efficacy and safety of the multimodal antidepressant vortioxetine in Japanese patients with MDD.
METHODS


Japanese patients aged 20-75 years with recurrent MDD and a Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 26 were randomized to vortioxetine 10 or 20 mg or placebo in a phase-3, double-blind, 8-week study. The primary end-point was change in MADRS total score from baseline. Secondary end-points included MADRS response and remission rates, change in Hamilton Rating Scale for Depression-17 item (HAM-D17) score, and other measures of depressive symptoms, including Clinical Global Impression of Severity (CGI-S), Clinical Global Impression of Improvement (CGI-I), and Sheehan Disability Scale (SDS). Cognitive function was assessed using Digit Symbol Substitution Test (DSST) score and Perceived Deficits Questionnaire-5 item (PDQ-5) score.
RESULTS


Vortioxetine 10 mg (n = 165) and 20 mg (n = 163) reduced MADRS total score by 2.66 and 3.07 points versus placebo (n = 161) after 8 weeks (P < 0.01 for each dose), respectively. MADRS response and remission rates were also significantly greater with vortioxetine than with placebo (P < 0.05 for both doses). Vortioxetine 10 and 20 mg significantly improved HAM-D17 score, CGI-I score, and SDS total score after 8 weeks. PDQ-5 score was significantly improved in subjects administered vortioxetine, while DSST scores showed no significant difference. Vortioxetine was generally well tolerated.
CONCLUSION


Vortioxetine at both the 10- and 20-mg/day doses demonstrated robust antidepressant efficacy in Japanese patients with MDD, and was well tolerated over the 8-week treatment period.",2020,MADRS response and remission rates were also significantly greater with vortioxetine than with placebo (P<0.05 for both doses).,"['Japanese Patients With Major Depressive Disorder', 'Japanese patients with MDD', 'Japanese patients aged 20-75\u2009years with recurrent MDD and a Montgomery-åsberg Depression Rating Scale (MADRS) score ≥26']","['PDQ-5', 'Placebo', 'vortioxetine', 'Vortioxetine', 'placebo', 'vortioxetine 10 or 20 mg or placebo', 'multimodal antidepressant vortioxetine']","['score', 'tolerated', 'efficacy and safety', 'MADRS response and remission rates, change in Hamilton Rating Scale for Depression-17 item score (HAM-D17) and other measures of depressive symptoms including Clinical Global Impression of Severity (CGI-S), Clinical Global Impression of Improvement (CGI-I), and Sheehan Disability Scale (SDS', 'Digit Symbol Substitution Test (DSST) score and Perceived Deficits Questionnaire-5 item (PDQ-5) score', 'Efficacy and Safety', 'MADRS total score', 'MADRS response and remission rates', 'HAM-D17 score, CGI-I score, and SDS total score', 'antidepressant efficacy', 'Cognitive function']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.200205,MADRS response and remission rates were also significantly greater with vortioxetine than with placebo (P<0.05 for both doses).,"[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Psychiatry, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kiyofumi', 'Initials': 'K', 'LastName': 'Sasai', 'Affiliation': 'Takeda Pharmaceutical Company Ltd, Osaka, Japan.'}, {'ForeName': 'Tadayuki', 'Initials': 'T', 'LastName': 'Kitagawa', 'Affiliation': 'Takeda Pharmaceutical Company Ltd, Osaka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Takeda Pharmaceutical Company Ltd, Osaka, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Inada', 'Affiliation': 'Takeda Pharmaceutical Company Ltd, Osaka, Japan.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.12956']
3082,31660693,Cognitive function assessment during 2 mA transcranial direct current stimulation in DLPFC in healthy volunteers.,"Although cognitive function has been reported to change following the anodal transcranial direct current stimulation (tDCS) but still variable results have been reported in healthy subject and there is paucity of data on the cognitive effects of online tDCS. Therefore, we aimed to assess the online effect of tDCS over the left dorsolateral prefrontal cortex (DLPFC) on cognitive function and obtain safety data in healthy adults. We recruited 36 healthy (20 male) participants for this double-blind, sham-controlled parallel design. We used Stop Signal Task (SST) Go Trial and Pattern Recognition Memory (PRM) tests to evaluate cognitive function during 2 mA (20 min) anodal or sham tDCS stimulation over the left DLPFC. In active conditions, left dorsolateral prefrontal cortex was selected for electrode placement with reference over right supraorbital cortex. All related tasks were done during the online tDCS section in both groups (active/sham). There were statistically significant differences in cognitive function according to the PRM test (P = 0.003), SST (P = 0.021), and SST correct response time on Go Trials (P = 0.02) during active stimulation compared to the sham group. Our results reveal that cognitive performance is affected by a single dose of active online tDCS over DLPFC area compared to sham stimulation. In our study, tDCS is well-tolerated and safe that further supports the safety of tDCS in local healthy population.",2019,"There were statistically significant differences in cognitive function according to the PRM test (P = 0.003), SST (P = 0.021), and SST correct response time on Go Trials (P = 0.02) during active stimulation compared to the sham group.","['healthy adults', '36 healthy (20 male) participants', 'healthy volunteers']","['anodal transcranial direct current stimulation (tDCS', 'tDCS', 'Cognitive function assessment during 2 mA transcranial direct current stimulation', '2\xa0mA (20\xa0min) anodal or sham tDCS stimulation', 'Stop Signal Task (SST']","['cognitive function', 'SST correct response time']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",36.0,0.134565,"There were statistically significant differences in cognitive function according to the PRM test (P = 0.003), SST (P = 0.021), and SST correct response time on Go Trials (P = 0.02) during active stimulation compared to the sham group.","[{'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Bashir', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Fawaz', 'Initials': 'F', 'LastName': 'Al-Hussain', 'Affiliation': 'Department of Neurology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hamza', 'Affiliation': 'Department of Electrical Engineering, National University of Computer and Emerging Sciences, Lahore, Pakistan.'}, {'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Asim Niaz', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Raidah', 'Initials': 'R', 'LastName': 'Albaradie', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Syed S', 'Initials': 'SS', 'LastName': 'Habib', 'Affiliation': 'Department of Physiology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}]",Physiological reports,['10.14814/phy2.14264']
3083,32020356,Exercise is more effective than health education in reducing fatigue in fatigued cancer survivors.,"INTRODUCTION


Cancer-related fatigue is a most debilitating side effect reported by survivors, often lasting years following treatment.
PURPOSE


To determine the effects of a 10-week exercise intervention compared with a health education intervention on fatigue, quality of life outcomes and functional fitness in cancer survivors with documented fatigue.
METHODS


This quasi-experimental study allocated 37 post-treatment fatigued cancer survivors (33 female, 30 breast cancer, aged 55 ± 2 years, time since treatment 2.3 ± 0.3 years; mean ± SEM) to an exercise group (EX, n = 19) or health education comparison group (HE, n = 18). The EX intervention emphasised brisk walking with progressive increments, stretching, exercise education and self-efficacy enhancement. The HE intervention emphasised sleep management, nutrition and cognitive behavioural therapy. All participants were evaluated at pre- and post-intervention with EX followed up at 26 W.
RESULTS


The intervention effect on fatigue (FACT-F) in EX was greater (p < 0.05) than that in HE, the difference being 4 times the recognised clinically important difference. The intervention also increased (p < 0.05) cognitive function, global quality of life and functional fitness scores. It reduced (p < 0.05) insomnia and fear of physical activity. All intervention effects were maintained to 26 W. The intervention effect on fatigue in EX was largely achieved by week 4. There was 100% retention rate at 10 W and no adverse events reported.
CONCLUSIONS


There is a reduction of considerable magnitude in cancer fatigue from group-based exercise training, that is sustainable and attributable to exercise per se.
IMPLICATIONS FOR CANCER SURVIVORS


Exercise training is feasible for fatigued cancer survivors and should form part of tailored rehabilitation programmes.",2020,"The intervention effect on fatigue (FACT-F) in EX was greater (p < 0.05) than that in HE, the difference being 4 times the recognised clinically important difference.","['fatigued cancer survivors', '37 post-treatment fatigued cancer survivors (33 female, 30 breast cancer, aged 55\u2009±\u20092\xa0years, time since treatment 2.3\u2009±\u20090.3\xa0years; mean ± SEM) to an exercise group (EX, n\u2009=\u200919) or health education comparison group (HE, n\u2009=\u200918', 'cancer survivors with documented fatigue']","['exercise intervention', 'Exercise training', 'Exercise', 'health education intervention']","['fatigue, quality of life outcomes and functional fitness', 'insomnia and fear of physical activity', 'retention rate', 'fatigue (FACT-F) in EX', 'cognitive function, global quality of life and functional fitness scores', 'fatigue in EX']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018701'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0264832,"The intervention effect on fatigue (FACT-F) in EX was greater (p < 0.05) than that in HE, the difference being 4 times the recognised clinically important difference.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sheehan', 'Affiliation': 'Department of Sport and Exercise Science, Waterford Institute of Technology, Cork Road, Waterford, Ireland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Denieffe', 'Affiliation': 'School of Humanities, Waterford Institute of Technology, Cork Road, Waterford, Ireland.'}, {'ForeName': 'Niamh M', 'Initials': 'NM', 'LastName': 'Murphy', 'Affiliation': 'Department of Sport and Exercise Science, Waterford Institute of Technology, Cork Road, Waterford, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Department of Sport and Exercise Science, Waterford Institute of Technology, Cork Road, Waterford, Ireland. mharrison@wit.ie.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05328-w']
3084,32026713,Information growth for sequential monitoring of clinical trials with a stepped wedge cluster randomized design and unknown intracluster correlation.,"BACKGROUND/AIMS


In a stepped wedge study design, study clusters usually start with the baseline treatment and then cross over to the intervention at randomly determined times. Such designs are useful when the intervention must be delivered at the cluster level and are becoming increasingly common in practice. In these trials, if the outcome is death or serious morbidity, one may have an ethical imperative to monitor the trial and stop before maximum enrollment if the new therapy is proven to be beneficial. In addition, because formal monitoring allows for the stoppage of trials when a significant benefit for new therapy has been ruled out, their use can make a research program more efficient. However, use of the stepped wedge cluster randomized study design complicates the implementation of standard group sequential monitoring methods. Both the correlation of observations introduced by the clustered randomization and the timing of crossover from one treatment to the other impact the rate of information growth, an important component of an interim analysis.
METHODS


We simulated cross-sectional stepped wedge study data in order to evaluate the impact of sequential monitoring on the Type I error and power when the true intracluster correlation is unknown. We studied the impact of varying intracluster correlations, treatment effects, methods of estimating the information growth, and boundary shapes.
RESULTS


While misspecified information growth can impact both the Type I error and power of a study in some settings, we observed little inflation of the Type I error and only moderate reductions in power across a range of misspecified information growth patterns in our simulations.
CONCLUSION


Taking the study design into account and using either an estimate of the intracluster correlation from the ongoing study or other data in the same clusters should allow for easy implementation of group sequential methods in future stepped wedge designs.",2020,"However, use of the stepped wedge cluster randomized study design complicates the implementation of standard group sequential monitoring methods.",[],[],['death or serious morbidity'],[],[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0910909,"However, use of the stepped wedge cluster randomized study design complicates the implementation of standard group sequential monitoring methods.","[{'ForeName': 'Siobhan P', 'Initials': 'SP', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': 'Division of Biostatistics, The Ohio State University, Columbus, OH, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520901488']
3085,30954341,High-nitrate salad increased plasma nitrates/nitrites and brachial artery flow-mediated dilation in postmenopausal women: A pilot study.,"Cardiovascular disease risk is elevated in postmenopausal women relative to men of the same age or to younger, premenopausal women. This elevated risk is closely linked to the loss of estrogen, which is a potent stimulator of the vasodilator nitric oxide. While studies have largely supported dietary nitrate supplementation (typically concentrated beetroot juice) to augment plasma nitric oxide, these studies focused mainly on improving vascular fitness of athletes or patient populations. The purpose of this controlled crossover trial was to assess the feasibility of consuming a high-nitrate, leafy green salad twice daily for 10 consecutive days versus a low-nitrate, canned vegetable control (beans, corn, or peas) on plasma nitrate/nitrite concentration and measures of cardiovascular health in postmenopausal women. We hypothesized that plasma nitrate/nitrite concentration and flow-mediated dilation would improve following the leafy green salad treatment. Ten women (52.6 ± 4.9 y; 26.4 ± 6.4 kg/m 2 ) completed the two 10-day treatment periods separated by 2-3 weeks washout. The mean fasting plasma nitrate/nitrite concentration was significantly increased following the high-nitrate salad treatment compared to the control (+156% and+ 16% respectively; P = .002, effect size = 0.661). Flow-mediated dilation responded favorably to the high nitrate salad in comparison to the canned vegetable condition (+17% versus -8% respectively; P = .047, effect size = 0.407); however, there were no treatment effects on peripheral or derived central-aortic blood pressure. These data suggest that daily ingestion of nitrate-rich, leafy green salads may prove a useful strategy for improving cardiovascular health in postmenopausal women.",2019,The mean fasting plasma nitrate/nitrite concentration was significantly increased following the high-nitrate salad treatment compared to the control (+156% and+ 16% respectively;,"['postmenopausal women', 'postmenopausal women relative to men of the same age or to younger, premenopausal women', 'Ten women (52.6\u202f±\u202f4.9 y; 26.4\u202f±\u202f6.4\u202fkg/m 2 ']","['low-nitrate, canned vegetable control (beans, corn, or peas']","['mean fasting plasma nitrate/nitrite concentration', 'Cardiovascular disease risk', 'peripheral or derived central-aortic blood pressure', 'plasma nitrate/nitrite concentration and measures of cardiovascular health', 'plasma nitrates/nitrites and brachial artery flow-mediated dilation', 'plasma nitrate/nitrite concentration and flow-mediated dilation', 'cardiovascular health']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0030738', 'cui_str': 'Peas'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",10.0,0.0342695,The mean fasting plasma nitrate/nitrite concentration was significantly increased following the high-nitrate salad treatment compared to the control (+156% and+ 16% respectively;,"[{'ForeName': 'Selicia T', 'Initials': 'ST', 'LastName': 'Mayra', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004. Electronic address: smayra@asu.edu.'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Johnston', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004. Electronic address: carol.johnston@asu.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Sweazea', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004; School of Life Sciences, Arizona State University, Phoenix, AZ 85004. Electronic address: karen.sweazea@asu.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.02.001']
3086,32025817,Determining the difference in the efficacy and safety of self-expandable metallic stents as a bridge to surgery for obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials.,"PURPOSE


This study compared the feasibility and safety of endoscopic placement of self-expandable metallic stents (SEMSs) as a bridge to surgery (BTS) between patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2.
METHODS


We conducted a post hoc analysis of two prospective, observational, single-arm multicenter clinical trials and performed a pooled analysis of the data. In total, 336 consecutive patients with malignant colorectal obstruction underwent SEMS placement. The primary endpoint was clinical success, defined as resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events.
RESULTS


High clinical (98.0% vs. 98.4%) and technical (96.7% vs. 97.8%) success rates were observed in both groups (CROSS 0 vs. CROSS 1 or 2). The adverse event rate was low. The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
CONCLUSION


This study was the first to compare the degree of stricture in different CROSS groups and demonstrated comparable results with respect to the short-term efficacy and safety of SEMS placement as a BTS for obstructive CRC in CROSS 0, 1, and 2 patients.",2020,"The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
","['336 consecutive patients with malignant colorectal obstruction underwent SEMS placement', 'patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2', 'obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials']","['endoscopic placement of self-expandable metallic stents (SEMSs', 'SEMS placement', 'self-expandable metallic stents']","['success rates', 'mean stricture length', 'efficacy and safety', 'technical success and adverse events', 'degree of stricture', 'adverse event rate', 'clinical success, defined as resolution of symptoms and radiological findings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metal Stents'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",336.0,0.0751036,"The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ohki', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. ohki.takeshi@twmu.ac.jp.""}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isayama', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Takeaki', 'Initials': 'T', 'LastName': 'Matsuzawa', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kuwai', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Shiratori', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Shimada', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Tomio', 'Initials': 'T', 'LastName': 'Hirakawa', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Saida', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}]",Surgery today,['10.1007/s00595-020-01970-3']
3087,32008572,Comparison of dental plaque reduction after use of electric toothbrushes with and without QLF-D-applied plaque visualization: a 1-week randomized controlled trial.,"BACKGROUND


To evaluate the efficacy of a newly developed electric toothbrush in reducing dental plaque via a quantitative light-induced fluorescence-digital (QLF-D)-applied visualisation system in the brush head.
METHODS


Participants included 20 adults aged 19 to 28 years. Participants were randomly assigned either (i) an electric toothbrush with a monitor to visualise red-fluorescent dental plaque via a camera built into the brush head (monitor usage group, n = 10) or (ii) an electric toothbrush without a monitor (monitor-non-use group, n = 10). The amount of dental plaque was assessed by personal hygiene performance (PHP) at baseline and 1 week later.
RESULTS


In the monitor-usage group, PHP score was significantly lower at the 1-week follow-up than at baseline (6 vs 16; range, 0-12 vs 13-21; P = 0.029). This change was not observed in the monitor-non-use group (14 vs 13; range, 6-21 vs 2-26; P = 0.778). After 1 week, the change in PHP scores in the monitor usage group was significantly greater than that in the monitor non-use group (- 10 vs 0; range, - 21 to 9 vs - 8 to 16; P = 0.021).
CONCLUSIONS


Our results clearly demonstrate that brushing teeth while looking at a monitor that depicts red-autofluorescent dental plaque via application of QLF-D improved the efficacy of dental-plaque removal relative to brushing teeth without a monitor.
TRIAL REGISTRATION


Trial registration number: UMIN000033699. Name of registry: Study on effect of new devise for oral care on dental plaque clearance. Date of registration: 8th September 2018. Status of registration: Completed.",2020,"After 1 week, the change in PHP scores in the monitor usage group was significantly greater than that in the monitor non-use group (- 10 vs 0; range, - 21 to 9 vs - 8 to 16; P = 0.021).
","['Name of registry', 'Participants included 20 adults aged 19 to 28\u2009years']","['electric toothbrush with a monitor to visualise red-fluorescent dental plaque via a camera built into the brush head (monitor usage group, n\xa0', 'electric toothbrush', 'electric toothbrushes with and without QLF-D-applied plaque visualization']","['change in PHP scores', 'dental plaque clearance', 'personal hygiene performance (PHP', 'PHP score']","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0011389', 'cui_str': 'Dental Plaque'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011389', 'cui_str': 'Dental Plaque'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0564673', 'cui_str': 'Personal hygiene activities, function (observable entity)'}]",20.0,0.124721,"After 1 week, the change in PHP scores in the monitor usage group was significantly greater than that in the monitor non-use group (- 10 vs 0; range, - 21 to 9 vs - 8 to 16; P = 0.021).
","[{'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Akifusa', 'Affiliation': 'School of Oral Health Sciences, Faculty of Dentistry, Kyushu Dental University, 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan. r11akifusa@fa.kyu-dent.ac.jp.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Isobe', 'Affiliation': 'School of Oral Health Sciences, Faculty of Dentistry, Kyushu Dental University, 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Kibata', 'Affiliation': 'School of Oral Health Sciences, Faculty of Dentistry, Kyushu Dental University, 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Oyama', 'Affiliation': 'HA-PPY Co, Ltd., 1041-57, Tsuruhata-cho, Kita-ku, Kumamoto, 861-5513, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Oyama', 'Affiliation': 'HA-PPY Co, Ltd., 1041-57, Tsuruhata-cho, Kita-ku, Kumamoto, 861-5513, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ariyoshi', 'Affiliation': 'Division of Infections and Molecular Biology, Department of Health Promotion, Kyushu Dental University, 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Tatsuji', 'Initials': 'T', 'LastName': 'Nishihara', 'Affiliation': 'Division of Infections and Molecular Biology, Department of Health Promotion, Kyushu Dental University, 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}]",BMC oral health,['10.1186/s12903-019-0982-3']
3088,30701691,Kinematic Visual Biofeedback Improves Accuracy of Swallowing Maneuver Training and Accuracy of Clinician Cues During Training in Stroke Patients with Dysphagia.,"BACKGROUND


Dysphagia (swallowing impairment) is a common and often life-threatening problem after stroke. Submental surface electromyography (ssEMG) visual biofeedback is a commonly used clinical tool to train novel swallowing maneuvers, even though its effectiveness has been questioned.
OBJECTIVE


To compare the effect of ssEMG and videofluoroscopy (VF) visual biofeedback on swallowing airway protection accuracy when training the volitional laryngeal closure swallowing maneuver (vLVC) in poststroke patients with dysphagia. Researchers also examined whether clinicians accurately judged vLVC performance. The hypothesis was that patient vLVC accuracy and clinician verbal cue accuracy will be greatest with VF (kinematic) visual biofeedback.
PATIENTS


Nineteen patients with dysphagia post stroke.
SETTING


Outpatient swallowing research laboratory.
DESIGN


Randomized clinical trial.
METHODS


Patients underwent 2 study phases. Phase 1: first demonstrated ability to perform the vLVC accurately. Phase 2: vLVC training. Participants were randomized into three biofeedback groups including the ssEMG group (ssEMG biofeedback in both phases), the VF group (VF biofeedback in both phases), and the mixed group (VF phase 1, ssEMG phase 2). To promote the best vLVC performance, a clinician provided real-time, verbal cueing using only the visual biofeedback type also seen by the patient, although both VF and ssEMG were recorded for all participants.
MAIN OUTCOME MEASURE


Patient performance accuracy and clinician feedback accuracy for performing the vLVC maneuver.
RESULTS


Both accuracy of vLVC training performance and clinician feedback accuracy were worse in the ssEMG group compared with the VF and mixed groups (P < .001).
CONCLUSIONS


Swallowing airway protection requires precisely timed movements of small, hidden laryngeal and pharyngeal structures. Kinematic biofeedback (VF) may be required, at some point, to ensure that target swallowing movements are being trained during rehabilitation, rather than maladaptive movements.
LEVEL OF EVIDENCE


I.",2019,"Both accuracy of vLVC training performance and clinician feedback accuracy were worse in the ssEMG group compared with the VF and mixed groups (P < .001).
","['Outpatient swallowing research laboratory', 'Stroke Patients with Dysphagia', 'poststroke patients with dysphagia', 'Patients underwent 2 study phases', 'Nineteen patients with dysphagia post stroke']","['ssEMG and videofluoroscopy (VF) visual biofeedback', 'Swallowing Maneuver Training and Accuracy of Clinician Cues', 'ssEMG group (ssEMG biofeedback', 'VF group (VF biofeedback', 'Kinematic Visual Biofeedback', 'Kinematic biofeedback (VF', 'volitional laryngeal closure swallowing maneuver (vLVC', 'Submental surface electromyography (ssEMG) visual biofeedback']","['vLVC accuracy and clinician verbal cue accuracy', 'swallowing airway protection accuracy', 'vLVC training performance and clinician feedback accuracy']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0035168'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",19.0,0.0306452,"Both accuracy of vLVC training performance and clinician feedback accuracy were worse in the ssEMG group compared with the VF and mixed groups (P < .001).
","[{'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Vose', 'Affiliation': 'University of Florida, College of Public Health and Health Professions, Rehabilitation Science, Gainesville, FL.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Marcus', 'Affiliation': 'Swallowing Systems Core, University of Florida, Gainesville, FL.'}, {'ForeName': 'Ianessa', 'Initials': 'I', 'LastName': 'Humbert', 'Affiliation': 'Swallowing Systems Core, University of Florida, Gainesville, FL.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12093']
3089,31879028,"Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.","BACKGROUND


Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial.
METHODS


The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651.
FINDINGS


Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24-2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74-1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66-5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25-2·40]; p=0·0009).
INTERPRETATION


In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation.
FUNDING


Biosensors.",2020,"Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation.
","['Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up', 'Patients with left main coronary artery disease requiring revascularisation', 'patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG', 'unprotected left main stenosis', '36 hospitals in nine northern European countries', '592 patients in each group were included in this analysis']","['Percutaneous coronary angioplasty versus coronary artery bypass grafting', 'PCI', 'PCI or CABG', 'Percutaneous coronary intervention (PCI', 'CABG']","['upper limit of the 95% CI of the hazard ratio (HR', 'procedural myocardial infarction', 'repeat revascularisation', 'Mortality', 'cause mortality, non-procedural myocardial infarction, and repeat revascularisation', 'rates of non-procedural myocardial infarction and repeat revascularisation', 'All-cause mortality', 'major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0190211', 'cui_str': 'Coronary angioplasty (procedure)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]",1201.0,0.340167,"Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation.
","[{'ForeName': 'Niels R', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Mäkikallio', 'Affiliation': 'Department of Cardiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'M Mitchell', 'Initials': 'MM', 'LastName': 'Lindsay', 'Affiliation': 'Department of Cardiology, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Spence', 'Affiliation': 'Belfast Heart Centre, Belfast Trust, Belfast, UK.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.'}, {'ForeName': 'Ian B A', 'Initials': 'IBA', 'LastName': 'Menown', 'Affiliation': 'Craigavon Cardiac Centre, Craigavon, UK.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Trovik', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kellerth', 'Affiliation': 'Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Gintaras', 'Initials': 'G', 'LastName': 'Kalinauskas', 'Affiliation': 'Vilnius University, Clinic of Cardiac and Vascular Diseases, Vilnius, Lithuania.'}, {'ForeName': 'Lone Juul Hune', 'Initials': 'LJH', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Per H', 'Initials': 'PH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiac Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Niemelä', 'Affiliation': 'Department of Cardiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Oldroyd', 'Affiliation': 'Department of Cardiology, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiac Surgery, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Peteris', 'Initials': 'P', 'LastName': 'Stradins', 'Affiliation': 'Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Walsh', 'Affiliation': 'Belfast Heart Centre, Belfast Trust, Belfast, UK.'}, {'ForeName': 'Alastair N J', 'Initials': 'ANJ', 'LastName': 'Graham', 'Affiliation': 'Belfast Heart Centre, Belfast Trust, Belfast, UK.'}, {'ForeName': 'Petter C', 'Initials': 'PC', 'LastName': 'Endresen', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Trivedi', 'Affiliation': 'Sussex Cardiac Centre, Brighton and Sussex University Hospital, Brighton, UK.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Anttila', 'Affiliation': 'Department of Cardiac Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': 'Sussex Cardiac Centre, Brighton and Sussex University Hospital, Brighton, UK.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Evald H', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: evald.christiansen@dadlnet.dk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32972-1']
3090,1681778,Cetirizine vs placebo in chronic idiopathic urticaria--a double blind randomised cross-over study.,"The efficacy of cetirizine dihydrochloride, a new H1-antagonist claimed to have minimal sedative property was evaluated in 28 patients with chronic idiopathic urticaria. Cetirizine 10 mg and placebo were compared in a double-blind cross-over trial. Response was measured by patients with daily charts on itch and wheals. Response was also assessed by patients and investigators while on cetirizine and placebo on an analogue scale. The mean analogue score by the investigator while on cetirizine (64.6 mm) was better than while on placebo (47.0 mm) (p = 0.008). Reduction of itch with cetirizine was significantly greater than with placebo. The mean itch scores for placebo and cetirizine were 21.2 and 14.5 respectively (p = 0.01) showing a significant improvement of itch by cetirizine. The mean score for wheal response for placebo and cetirizine were 21.0 and 16.16 respectively (p = 0.07 NS) showing a reduction of wheal from cetirizine was greater than placebo but the difference was not statistically significant. The patients' mean visual analogue score for placebo was 38.4 and for cetirizine was 57.5 (p = 0.006). Cetirizine was significantly better in controlling symptoms of chronic urticaria than placebo. Five of the 28 (17.9%) patients reported mild drowsiness while taking cetirizine. Two patients reported drowsiness while on placebo. Tolerance was reported as good in 85%, moderate in 10% and bad in 5% according to patients' assessment, while tolerance was excellent and good in 80%, moderate in 15% of patients according to investigator's assessment.",1991,The patients' mean visual analogue score for placebo was 38.4 and for cetirizine was 57.5 (p = 0.006).,"['28 patients with chronic idiopathic urticaria', 'chronic idiopathic urticaria']","['placebo', 'cetirizine dihydrochloride', 'cetirizine and placebo', 'Cetirizine', 'cetirizine']","['mean visual analogue score', 'drowsiness', 'mean itch scores', 'Tolerance', 'mean score for wheal response', 'mild drowsiness', 'mean analogue score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700480', 'cui_str': 'cetirizine hydrochloride'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]",28.0,0.144925,The patients' mean visual analogue score for placebo was 38.4 and for cetirizine was 57.5 (p = 0.006).,"[{'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Goh', 'Affiliation': 'National Skin Centre, Singapore.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3091,32018274,"The Effect of Acupressure on the Severity of Nausea, Vomiting, and Retching in Pregnant Women: A Randomized Controlled Trial.","INTRODUCTION


Nausea and vomiting are common problems during pregnancy. Previous studies have shown that stimulation at Neiguan (PC6) acupoint can be effective in controlling pregnancy-induced nausea and vomiting. However, more evidence is required for approving this method on controlling pregnancy-induced nausea and vomiting. The aim of this study was to determine the efficacy of PC6 acupoint pressure stimulation on the severity of nausea, vomiting, and retching in pregnant women.
METHOD


This randomized, multi-center clinical trial was conducted on pregnant women referring to Health Centers and Ommolbanin Hospital in Mashhad, Iran, during December 2016 to September 2017. Women with first singleton pregnancy and below 12 weeks were included. Patients were randomly allocated into three groups of (1) PC6 pressure (4 times a day, for 10 min), (2) sham acupressure, and (3) medication with vitamin B6 and metoclopramide. Assessment of severity of nausea, vomiting, and retching was done based on the Rhodes Index on the first and fifth day (before and after the intervention). Pearson chi-square test, one-way ANOVA, Kruskal-Wallis, and Wilcoxon tests were used for statistical analysis using SPSS version 18. This clinical trial was registered at the Iranian Registry of Clinical Trials (IRCT) with the code IRCT201512187265N6.
RESULTS


Ninety patients with a mean age of 26.40 ± 4.73 years were studied in 3 groups of 30. There was no significant difference between the 3 groups in terms of the severity outcomes before the intervention, while, after the intervention, the three groups were significantly different on the fifth day in terms of vomiting frequency, distress from retching, distress from vomiting, duration of nausea, distress from nausea, amount of vomiting, frequency of nausea, and frequency of retching (p < 0.001 for each outcome). According to the linear regression analysis, the correlation between occupation with vomiting frequency (beta coefficient = 0.252) and nausea severity (beta coefficient = -0.213) was statistically significant.
CONCLUSION


It seems that PC6 acupoint pressure can reduce the severity of nausea, vomiting, and retching in pregnant women.",2020,"It seems that PC6 acupoint pressure can reduce the severity of nausea, vomiting, and retching in pregnant women.","['pregnant women', 'pregnant women referring to Health Centers and Ommolbanin Hospital in Mashhad, Iran, during December 2016 to September 2017', 'Women with first singleton pregnancy and below 12 weeks were included', 'Ninety patients with a mean age of 26.40 ± 4.73 years were studied in 3 groups of 30', 'Pregnant Women']","['Neiguan (PC6) acupoint', 'PC6 acupoint pressure', 'Acupressure', 'PC6 acupoint pressure stimulation', 'sham acupressure, and (3) medication with vitamin B6 and metoclopramide']","['vomiting frequency', 'severity of nausea, vomiting, and retching', 'Nausea and vomiting', 'nausea and vomiting', 'vomiting frequency, distress from retching, distress from vomiting, duration of nausea, distress from nausea, amount of vomiting, frequency of nausea, and frequency of retching', 'Severity of Nausea, Vomiting, and Retching', 'severity outcomes', 'nausea severity', 'nausea, vomiting, and retching']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0450694', 'cui_str': 'PC6 (body structure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232602', 'cui_str': 'Retching (finding)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",90.0,0.0441676,"It seems that PC6 acupoint pressure can reduce the severity of nausea, vomiting, and retching in pregnant women.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Tara', 'Affiliation': 'Department of Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Bahrami-Taghanaki', 'Affiliation': 'Department of Chinese and Complementary Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini Ghalandarabad', 'Affiliation': 'Medical student, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Zand-Kargar', 'Affiliation': 'Gynecologist, Mashhad, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Azizi', 'Affiliation': 'Gynecologist, Mashhad, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Esmaily', 'Affiliation': 'Department of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Azizi', 'Affiliation': 'Department of Chinese and Complementary Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran, azizi.h.md@gmail.com.'}]",Complementary medicine research,['10.1159/000505637']
3092,1679316,Nizatidine versus cimetidine in the treatment of duodenal ulcers.,"An open comparative trial of nizatidine in the treatment of duodenal ulcer (DU) was carried out with cimetidine as control. Forty-three patients with endoscopically proven DU were recruited into the study. Twenty-three patients were assigned to treatment with nizatidine 300 mg daily and 20 patients (controls) were on cimetidine 800 mg daily. Both groups were comparable in age and sex distribution - age range 21 to 74 years; mean 53.4 years and 43 years in the nizatidine and cimetidine groups respectively. Liver function tests, full blood counts, platelets, urea, electrolytes were done together with endoscopy at four, eight, twelve weeks. In the nizatidine group, 16 patients completed the study whilst 17 patients on cimetidine completed the study. Healing rates at four and eight weeks on nizatidine were 9/16 (56%) and 14/16 (87.5%) respectively. On cimetidine, healing rates at four and eight weeks were 14/17 (80%) and 16/17 (94%) respectively. There was no statistical difference in healing rates between the two groups at four and eight weeks (p = 0.1, p = 0.47). One patient on nizatidine developed urticaria rash which resolved on drug withdrawal. No other adverse clinical or biochemical effects were observed in the cohort after twelve weeks of treatment. Nizatidine is as effective as cimetidine in healing DU at four and eight weeks.",1991,"There was no statistical difference in healing rates between the two groups at four and eight weeks (p = 0.1, p = 0.47).","['Both groups were comparable in age and sex distribution - age range 21 to 74 years; mean 53.4 years and 43 years in the', 'duodenal ulcer (DU', '16 patients completed the study whilst 17 patients on', 'duodenal ulcers', 'Forty-three patients with endoscopically proven DU']","['Nizatidine', 'cimetidine', 'nizatidine', 'nizatidine and cimetidine']","['Healing rates', 'healing rates', 'adverse clinical or biochemical effects', 'urticaria rash', 'Liver function tests, full blood counts, platelets, urea, electrolytes']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013295', 'cui_str': 'Duodenal Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]","[{'cui': 'C0085154', 'cui_str': 'Nizatidine'}, {'cui': 'C0008783', 'cui_str': 'Cimetidine'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0042109', 'cui_str': 'Hives'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}]",23.0,0.0140148,"There was no statistical difference in healing rates between the two groups at four and eight weeks (p = 0.1, p = 0.47).","[{'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Yap', 'Affiliation': 'Toa Payoh Hospital, Department of Medicine, Singapore.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Chong', 'Affiliation': ''}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Chia', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Fock', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3093,31340116,Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis.,"BACKGROUND


Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism. Additional data are needed regarding the effectiveness and safety of roxadustat as compared with standard therapy (epoetin alfa) for the treatment of anemia in patients undergoing dialysis.
METHODS


In a trial conducted in China, we randomly assigned (in a 2:1 ratio) patients who had been undergoing dialysis and erythropoiesis-stimulating agent therapy with epoetin alfa for at least 6 weeks to receive roxadustat or epoetin alfa three times per week for 26 weeks. Parenteral iron was withheld except as rescue therapy. The primary end point was the mean change in hemoglobin level from baseline to the average level during weeks 23 through 27. Noninferiority of roxadustat would be established if the lower boundary of the two-sided 95% confidence interval for the difference between the values in the roxadustat group and epoetin alfa group was greater than or equal to -1.0 g per deciliter. Patients in each group had doses adjusted to reach a hemoglobin level of 10.0 to 12.0 g per deciliter. Safety was assessed by analysis of adverse events and clinical laboratory values.
RESULTS


A total of 305 patients underwent randomization (204 in the roxadustat group and 101 in the epoetin alfa group), and 256 patients (162 and 94, respectively) completed the 26-week treatment period. The mean baseline hemoglobin level was 10.4 g per deciliter. Roxadustat led to a numerically greater mean (±SD) change in hemoglobin level from baseline to weeks 23 through 27 (0.7±1.1 g per deciliter) than epoetin alfa (0.5±1.0 g per deciliter) and was statistically noninferior (difference, 0.2±1.2 g per deciliter; 95% confidence interval [CI], -0.02 to 0.5). As compared with epoetin alfa, roxadustat increased the transferrin level (difference, 0.43 g per liter; 95% CI, 0.32 to 0.53), maintained the serum iron level (difference, 25 μg per deciliter; 95% CI, 17 to 33), and attenuated decreases in the transferrin saturation (difference, 4.2 percentage points; 95% CI, 1.5 to 6.9). At week 27, the decrease in total cholesterol was greater with roxadustat than with epoetin alfa (difference, -22 mg per deciliter; 95% CI, -29 to -16), as was the decrease in low-density lipoprotein cholesterol (difference, -18 mg per deciliter; 95% CI, -23 to -13). Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group. Hyperkalemia and upper respiratory infection occurred at a higher frequency in the roxadustat group, and hypertension occurred at a higher frequency in the epoetin alfa group.
CONCLUSIONS


Oral roxadustat was noninferior to parenteral epoetin alfa as therapy for anemia in Chinese patients undergoing dialysis. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652806.).",2019,"Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group.","['patients undergoing dialysis', 'Chinese patients undergoing dialysis', '305 patients underwent randomization (204 in the roxadustat group and 101 in the epoetin alfa group), and 256 patients (162 and 94, respectively) completed the 26-week treatment period', 'Patients Undergoing Long-Term Dialysis', '2:1 ratio) patients who had been undergoing dialysis and erythropoiesis-stimulating agent therapy with epoetin alfa for at least 6 weeks to receive']","['FibroGen and FibroGen', 'parenteral epoetin alfa', 'roxadustat or epoetin alfa', 'standard therapy (epoetin alfa']","['mean (±SD) change in hemoglobin level', 'low-density lipoprotein cholesterol', 'hemoglobin level', 'mean change in hemoglobin level', 'transferrin saturation', 'transferrin level', 'serum iron level', 'hypertension', 'adverse events and clinical laboratory values', 'total cholesterol', 'mean baseline hemoglobin level', 'Hyperkalemia and upper respiratory infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4310578'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}]","[{'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C4310578'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0202105', 'cui_str': 'Transferrin measurement (procedure)'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",305.0,0.306271,"Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chuanming', 'Initials': 'C', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Bi-Cheng', 'Initials': 'BC', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Caili', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Changying', 'Initials': 'C', 'LastName': 'Xing', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Gengru', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Laimin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Zhao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Guang-Yan', 'Initials': 'GY', 'LastName': 'Cai', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leong', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Szczech', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Kin-Hung P', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}]",The New England journal of medicine,['10.1056/NEJMoa1901713']
3094,32017923,Metformin use in obese mothers is associated with improved cardiovascular profile in the offspring.,"BACKGROUND


Maternal obesity increases the risk for pregnancy complications and adverse neonatal outcome and has been associated with long-lasting adverse effects in the offspring, including increased body fat mass, insulin resistance, and increased risk for premature cardiovascular disease. Lifestyle interventions in pregnancy have produced no or modest effects in the reduction of adverse pregnancy outcomes in obese mothers. The Metformin in Obese Pregnant Women trial was associated with reduced adverse pregnancy outcomes and had no effect on birthweight. However, the long-term implications of metformin on the health of offspring remain unknown.
OBJECTIVE


The purpose of this study was to assess whether prenatal exposure to metformin can improve the cardiovascular profile and body composition in the offspring of obese mothers.
STUDY DESIGN


In 151 children from the Metformin in Obese Pregnant Women trial, body composition, peripheral blood pressure, and arterial pulse wave velocity were measured. Central hemodynamics (central blood pressure and augmentation index) were estimated with the use of an oscillometric device. Left ventricular cardiac function and structure were assessed by echocardiography.
RESULTS


Children were 3.9±1.0 years old, and 77 of them had been exposed to metformin prenatally. There was no significant difference in peripheral blood pressure, arterial stiffness, and body composition apart from gluteal and tricep circumferences, which were lower in the metformin group (P<.05). The metformin group, compared with the placebo group, had lower central hemodynamics (mean adjusted decrease, -0.707 mm Hg for aortic systolic blood pressure, -1.65 mm Hg for aortic pulse pressure, and -2.68% for augmentation index; P<.05 for all) and lower left ventricular diastolic function (adjusted difference in left atrial area, -0.525 cm 2 , in isovolumic relaxation time, -0.324 msec, and in pulmonary venous systolic wave, 2.97 cm/s; P<.05 for all). There were no significant differences in metabolic profile between the groups.
CONCLUSION


Children of obese mothers who were exposed prenatally to metformin, compared with those who were exposed to placebo, had lower central hemodynamic and cardiac diastolic indices. These results suggest that the administration of metformin in obese pregnant women potentially may have a beneficial cardiovascular effect for their offspring.",2020,"The metformin, compared to the placebo group, had lower central hemodynamics (mean adjusted decrease -0.707mmHg for aortic systolic blood pressure, -1.65mmHg for aortic pulse pressure and -2.68% for augmentation index, p<0.05 for all) and lower left ventricular diastolic function (adjusted difference in left atrial area -0.525cm 2 , in isovolumic relaxation time -0.324msec and in pulmonary venous systolic wave 2.97cm/s, p<0.05 for all).","['offspring of obese mothers', 'Children of obese mothers', 'Obese mothers', 'obese mothers', '151 children from the', 'Children were 3.9±1.0 years of age and 77 were exposed to metformin prenatally', 'obese pregnant women', 'Obese Pregnant women trial']","['metformin', 'placebo', 'Metformin']","['metabolic profile', 'cardiovascular profile and body composition', 'adverse pregnancy outcomes', 'Central hemodynamics (central blood pressure and augmentation index', 'lower central hemodynamics', 'body composition, peripheral blood pressure and arterial pulse wave velocity', 'peripheral blood pressure, arterial stiffness and body composition apart from gluteal and tricep circumferences', 'aortic systolic blood pressure, -1.65mmHg for aortic pulse pressure', 'central hemodynamic and cardiac diastolic indices', 'left ventricular diastolic function', 'birthweight']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C3494282', 'cui_str': 'Aortic Pulse Pressure'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",151.0,0.0623254,"The metformin, compared to the placebo group, had lower central hemodynamics (mean adjusted decrease -0.707mmHg for aortic systolic blood pressure, -1.65mmHg for aortic pulse pressure and -2.68% for augmentation index, p<0.05 for all) and lower left ventricular diastolic function (adjusted difference in left atrial area -0.525cm 2 , in isovolumic relaxation time -0.324msec and in pulmonary venous systolic wave 2.97cm/s, p<0.05 for all).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Panagiotopoulou', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Argyro', 'Initials': 'A', 'LastName': 'Syngelaki', 'Affiliation': ""Harris Birthright Research Centre for Fetal Medicine, Fetal Medicine Research Institute, King's College Hospital, London, UK.""}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Georgiopoulos', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Akolekar', 'Affiliation': 'Fetal Medicine Unit, Medway Maritime Hospital, Gillingham, UK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Shehata', 'Affiliation': 'Department of Maternal Medicine, Epsom and St Helier University Hospitals NHS Trust, Surrey, UK.'}, {'ForeName': 'Kypros', 'Initials': 'K', 'LastName': 'Nicolaides', 'Affiliation': ""Harris Birthright Research Centre for Fetal Medicine, Fetal Medicine Research Institute, King's College Hospital, London, UK.""}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Charakida', 'Affiliation': ""Harris Birthright Research Centre for Fetal Medicine, Fetal Medicine Research Institute, King's College Hospital, London, UK; School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK. Electronic address: Marietta.charakida@kcl.ac.uk.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.054']
3095,32020032,Timing of exercise for muscle strength and physical function in men initiating ADT for prostate cancer.,"BACKGROUND


Androgen deprivation therapy (ADT) in men with prostate cancer (PCa) results in adverse effects, including reduced muscle strength and physical function, potentially compromising daily functioning. We examined whether it was more efficacious to commence exercise at the onset of ADT rather than later in treatment to counter declines in strength and physical function.
METHODS


One-hundred-and-four men with PCa (68.3 ± 7.0 years) initiating ADT were randomised to immediate exercise (IMX, n = 54) or delayed exercise (DEL, n = 50) for 12 months. IMX comprised 6 months of supervised resistance/aerobic/impact exercise initiated at the onset of ADT with a 6-month follow-up. DEL comprised 6 months of usual care followed by 6 months of resistance/aerobic/impact exercise. Upper and lower body muscle strength and physical function were assessed at baseline, 6 and 12 months.
RESULTS


There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively. From 7 to 12 months, DEL increased in all strength measures (P < 0.001), with no differences between groups at 12 months. Similarly, physical function improved (P < 0.001) in IMX compared with DEL at 6 months for the 6-m fast walk (-0.2, 95% CI -0.3 to -0.1 s), 400-m walk (-9.7, -14.8 to -4.6 s), stair climb (-0.4, -0.6 to -0.2 s) and chair rise (-1.0, -1.4 to -0.7 s), with no differences between groups by 12 months, except for the 6-m fast walk (P < 0.001).
CONCLUSION


Exercise either at the onset or after 6 months of ADT preserves/enhances muscle strength and physical function. However, to avoid initial treatment-related adverse effects on strength and function, exercise therapy should be implemented with initiation of ADT.",2020,"There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively.","['men with prostate cancer (PCa', 'One-hundred-and-four men with PCa (68.3\u2009±\u20097.0 years) initiating ADT', 'men initiating ADT for prostate cancer']","['immediate exercise (IMX, n\u2009=\u200954) or delayed exercise (DEL', 'IMX', 'Androgen deprivation therapy (ADT']","['strength measures', 'physical function', 'chair rise', 'stair climb', 'leg press, seated row and chest press strength', 'Upper and lower body muscle strength and physical function', 'muscle strength and physical function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",104.0,0.0802218,"There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively.","[{'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia. r.newton@ecu.edu.au.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Galvão', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Chambers', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gardiner', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Dickon', 'Initials': 'D', 'LastName': 'Hayne', 'Affiliation': 'UWA Medical School, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Taaffe', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0200-z']
3096,32002617,A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer.,"PURPOSE


Trastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken.
METHODS


The trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumab-based neo/adjuvant chemotherapy for early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.
RESULTS


During the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual.
CONCLUSION


The study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02632435.",2020,"Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.
","['patients receiving chemotherapy with trastuzumab for early-stage breast cancer', 'for early-stage breast cancer', 'Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8']","['PICC or PORT insertion', 'trastuzumab-based neo/adjuvant chemotherapy', 'Trastuzumab-based chemotherapy']","['rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}]",59.0,0.180013,"Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada. mclemons@toh.ca.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kehoe', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Bedard', 'Affiliation': 'Department of Nursing, Ottawa General Hospital, Ottawa, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'MacDonald', 'Affiliation': 'Department of Nursing, Ottawa General Hospital, Ottawa, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Brunet', 'Affiliation': 'Department of Nursing, Ottawa General Hospital, Ottawa, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Mazzarello', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Awan', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Basulaiman', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Division of Medical Oncology, Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05326-y']
3097,30726985,"Feasibility of App-Based Postsurgical Assessment of Pain, Pain Impact, and Regional Anesthesia Effects: A Pilot Randomized Controlled Trial.","OBJECTIVE


Postsurgical follow-up calls enable nurses to assess a patient's condition, provide tailored education, and improve the patient's experience. Despite the benefits, barriers to phone-based assessments may include patient nonresponse and lack of time due to demanding clinical schedules. The purpose of this trial was to examine the feasibility and utility of a smartphone app, mCare, for assessing pain, pain impact, and peripheral nerve block effects in patients.
DESIGN


Pilot randomized control trial.
SETTING AND PATIENTS


Eligible patients at a military treatment facility undergoing same-day surgery were randomized to the mCare group (N = 24) or the standard-of-care telephone (N = 26) group.
RESULTS


Outcomes included initial response (assessment completion) rates and participant and nurse satisfaction. There were no differences in the response rates upon initial contact attempt, and patients in both groups reported similar levels of satisfaction and convenience. Nurses reported greater satisfaction with the app compared with standard-of-care telephone calls.
CONCLUSIONS


Before wider implementation, further considerations of app-based assessment need to be fully explored.",2019,"There were no differences in the response rates upon initial contact attempt, and patients in both groups reported similar levels of satisfaction and convenience.","['Patients\n\n\nEligible patients at a military treatment facility undergoing same-day surgery', 'patients']","['App-Based Postsurgical Assessment', 'mCare group (N\u2009=\u200924) or the standard-of-care telephone (N\u2009=\u200926) group', 'smartphone app, mCare']","['response rates', 'pain, pain impact, and peripheral nerve block effects', 'initial response (assessment completion) rates and participant and nurse satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.20577,"There were no differences in the response rates upon initial contact attempt, and patients in both groups reported similar levels of satisfaction and convenience.","[{'ForeName': 'Krista B', 'Initials': 'KB', 'LastName': 'Highland', 'Affiliation': 'Defense and Veterans Center for Integrative Pain Management, Uniformed Services University Henry M. Jackson Foundation, Rockville, Maryland, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'Defense and Veterans Center for Integrative Pain Management, Uniformed Services University Henry M. Jackson Foundation, Rockville, Maryland, USA.'}, {'ForeName': 'Hisani', 'Initials': 'H', 'LastName': 'Edwards', 'Affiliation': 'Defense and Veterans Center for Integrative Pain Management, Uniformed Services University Henry M. Jackson Foundation, Rockville, Maryland, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bedocs', 'Affiliation': 'Defense and Veterans Center for Integrative Pain Management, Uniformed Services University Henry M. Jackson Foundation, Rockville, Maryland, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Suen', 'Affiliation': 'Defense and Veterans Center for Integrative Pain Management, Uniformed Services University Henry M. Jackson Foundation, Rockville, Maryland, USA.'}, {'ForeName': 'Chester C', 'Initials': 'CC', 'LastName': 'Buckenmaier', 'Affiliation': 'Defense and Veterans Center for Integrative Pain Management, Uniformed Services University Henry M. Jackson Foundation, Rockville, Maryland, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny288']
3098,1295415,"A double-blind, randomised, cross-over study comparing the 50g OGTT and the 75g OGTT for pregnant women in the third trimester.","There is little consensus in the conduct and interpretation of the oral glucose tolerance test (OGTT) in pregnancy. In Singapore much data has been accumulated about the 50g OGTT while the converse is true of the 75g OGTT. A double-blind, randomised, crossover study of 56 subjects in the third trimester was conducted to compare both glucose challenges to determine if there was a difference in glucose handling in the context of a two hour OGTT. A significant difference (p < 0.001, t = 5.76) was found at two hours where the mean glucose concentrations were 5.2 +/- 0.8 mmol/L and 6.2 +/- 1.4 mmol/L for the 50g and 75g OGTT respectively. These findings suggest that the 75g OGTT is potentially more effective in unmasking pregnant subjects with impaired glucose tolerance.",1992,These findings suggest that the 75g OGTT is potentially more effective in unmasking pregnant subjects with impaired glucose tolerance.,"['pregnant women in the third trimester', '56 subjects in the third trimester', 'unmasking pregnant subjects with impaired glucose tolerance']",[],['mean glucose concentrations'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}]",,0.0917665,These findings suggest that the 75g OGTT is potentially more effective in unmasking pregnant subjects with impaired glucose tolerance.,"[{'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Cheng', 'Affiliation': ""Academic Department of Obstetrics and Gynaecology, King's College School of Medicine and Dentistry, London, United Kingdom.""}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Salmon', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3099,31988711,"The effect of a single spinal manipulation on cardiovascular autonomic activity and the relationship to pressure pain threshold: a randomized, cross-over, sham-controlled trial.","Background


The autonomic nervous system interacts with the pain system. Knowledge on the effects of high velocity low amplitude spinal manipulations (SM) on autonomic activity and experimentally induced pain is limited. In particular, the effects of SM on autonomic activity and pain beyond the immediate post intervention period as well as the relationship between these two outcomes are understudied. Thus, new research is needed to provide further insight on this issue.
Objectives


The aim was to assess the effect of a single SM (i.e. SM vs. sham) on cardiovascular autonomic activity. Also, we assessed the relationship between cardiovascular autonomic activity and level of pain threshold after the interventions.
Method


We conducted a randomized, cross-over, sham-controlled trial on healthy first-year chiropractic students comprising two experimental sessions separated by 48 h. During each session, subjects received, in a random order, either a thoracic SM or a sham manipulation. Cardiovascular autonomic activity was assessed using heart rate and systolic blood pressure variabilities. Pain sensitivity was assessed using pressure pain threshold. Measurements were performed at baseline and repeated three times (every 12 min) during the post intervention period. Participants and outcome assessors were blinded. The effect of the SM was tested with linear mixed models. The relationship between autonomic outcomes and pressure pain threshold was tested with bivariate correlations.
Results


Fifty-one participants were included, forty-one were finally analyzed. We found no statistically significant difference between SM and sham in cardiovascular autonomic activity post intervention. Similarly, we found no post-intervention relationship between cardiovascular autonomic activity and pressure pain threshold.
Conclusion


Our results suggest that a single SM of the thoracic spine has no specific effect on cardiovascular autonomic activity. Also, we found no relationship between cardiovascular autonomic activity and pressure pain threshold after the SM. Further experimental research should consider the use of several markers of autonomic activity and a more comprehensive pain assessment.
Trial registration


N° NCT03273868. Registered September 6, 2017.",2020,We found no statistically significant difference between SM and sham in cardiovascular autonomic activity post intervention.,"['healthy first-year chiropractic students comprising two experimental sessions separated by 48\u2009h', 'Fifty-one participants were included, forty-one were finally analyzed']","['thoracic SM or a sham manipulation', 'high velocity low amplitude spinal manipulations (SM', 'single spinal manipulation', 'SM', 'single SM']","['heart rate and systolic blood pressure variabilities', 'Cardiovascular autonomic activity', 'cardiovascular autonomic activity and level of pain threshold', 'Pain sensitivity', 'cardiovascular autonomic activity and pressure pain threshold', 'cardiovascular autonomic activity', 'cardiovascular autonomic activity and pressure pain', 'autonomic activity and pain']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",51.0,0.0981695,We found no statistically significant difference between SM and sham in cardiovascular autonomic activity post intervention.,"[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Picchiottino', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Honoré', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gagey', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Cottin', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hallman', 'Affiliation': '5Centre for Musculoskeletal Research, Department of Occupational and Public Health Sciences, University of Gävle, Gävle, Sweden.'}]",Chiropractic & manual therapies,['10.1186/s12998-019-0293-4']
3100,32014432,Impact on mortality after implementation of a network for ST-segment elevation myocardial infarction care. The IPHENAMIC study.,"INTRODUCTION AND OBJECTIVES


Little is known about the impact of networks for ST-segment elevation myocardial infarction (STEMI) care on the population. The objective of this study was to determine whether the PROGALIAM (Programa Gallego de Atención al Infarto Agudo de Miocardio) improved survival in northern Galicia.
METHODS


We collected all events coded as STEMI between 2001 and 2013. A total of 6783 patients were identified and divided into 2 groups: pre-PROGALIAM (2001-2005), with 2878 patients, and PROGALIAM (2006-2013), with 3905 patients.
RESULTS


In the pre-PROGALIAM period, 5-year adjusted mortality was higher both in the total population (HR, 1.22, 95%CI, 1.14-1.29; P <.001) and in each area (A Coruña: HR, 1.12; 95%CI, 1.02-1.23; P=.02; Lugo: HR, 1.34; 95%CI, 1.2-1.49; P <.001 and Ferrol: HR, 1.23; 95%CI, 1.1-1.4; P=.001). Before PROGALIAM, 5-year adjusted mortality was higher in the areas of Lugo (HR, 1.25; 95%CI, 1.05-1.49; P=.02) and Ferrol (HR, 1.32; 95%CI, 1.13-1.55; P=.001) than in A Coruña. These differences disappeared after the creation of the STEMI network (Lugo vs A Coruña: HR, 0.88; 95%CI, 0.72-1.06; P=.18, Ferrol vs A Coruña: HR, 1.04; 95%CI, 0.89-1.22; P=.58.
CONCLUSIONS


For patients with STEMI, the creation of PROGALIAM in northern Galicia decreased mortality and increased equity in terms of survival both overall and in each of the areas where it was implemented. This study was registered at ClinicalTrials.gov (Identifier: NCT02501070).",2020,"In the pre-PROGALIAM period, 5-year adjusted mortality was higher both in the total population (HR, 1.22, 95%CI, 1.14-1.29; P <.001) and in each area (A Coruña: HR, 1.12; 95%CI, 1.02-1.23; P=.02; Lugo: HR, 1.34; 95%CI, 1.2-1.49; P <.001 and Ferrol: HR, 1.23; 95%CI, 1.1-1.4; P=.001).","['6783 patients were identified and divided into 2 groups: pre-PROGALIAM (2001-2005), with 2878 patients, and PROGALIAM (2006-2013), with 3905 patients']",[],"['mortality', '5-year adjusted mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",6783.0,0.313738,"In the pre-PROGALIAM period, 5-year adjusted mortality was higher both in the total population (HR, 1.22, 95%CI, 1.14-1.29; P <.001) and in each area (A Coruña: HR, 1.12; 95%CI, 1.02-1.23; P=.02; Lugo: HR, 1.34; 95%CI, 1.2-1.49; P <.001 and Ferrol: HR, 1.23; 95%CI, 1.1-1.4; P=.001).","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Aldama', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain. Electronic address: guillermo.aldama.lopez@sergas.es.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'López', 'Affiliation': 'Servicio de Cardiología, Hospital Arquitecto Marcide, Ferrol, A Coruña, Spain.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Santás', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Xacobe', 'Initials': 'X', 'LastName': 'Flores', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Piñón', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Salgado', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Calviño', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Vázquez', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Mesías', 'Affiliation': 'Servicio de Cardiología, Hospital Arquitecto Marcide, Ferrol, A Coruña, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'González-Juanatey', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muñiz', 'Affiliation': 'Instituto Universitario de Ciencias de la Salud, Universidad de A Coruña, A Coruña, Spain; Instituto de Investigación Biomédica de A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vázquez', 'Affiliation': 'Servicio de Cardiología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2019.09.031']
3101,1292407,An assessment of preoxygenation techniques using the pulse oximeter.,"The effect of preoxygenation with varying inspired oxygen concentration on the arterial oxygen saturation during induction of anaesthesia and intubation was studied using the pulse oximeter. Sixty-five healthy, young adults, (American Society of Anaesthesiologists Class I) undergoing elective surgery were randomly divided into three groups. Group I patients were not preoxygenated. Groups II and III patients were preoxygenated with 50% oxygen and nitrous oxide and 100% oxygen respectively for one minute. All were then induced with thiopentone, paralysed with suxamethonium and orally intubated. During intubation, severe arterial desaturation occurred in those patients who were not preoxygenated (lowest saturation was 81.7 +/- 7.8% occurring 87 +/- 24.5 seconds after suxamethonium injection). This was significantly lower than the other two groups (p < 0.001). No patient had clinical signs of hypoxaemia. Patients who were preoxygenated with either 50% oxygen and nitrous oxide or 100% oxygen showed similar and clinically insignificant desaturation during this period. One minute after intubation and manual ventilation with 100% oxygen, the saturations of all patients returned to preinduction levels.",1992,"One minute after intubation and manual ventilation with 100% oxygen, the saturations of all patients returned to preinduction levels.","['Sixty-five healthy, young adults, (American Society of Anaesthesiologists Class I) undergoing elective surgery']","['preoxygenated with 50% oxygen and nitrous oxide', 'thiopentone', 'suxamethonium and orally intubated', 'nitrous oxide', 'preoxygenation with varying inspired oxygen concentration']","['arterial oxygen saturation', 'clinical signs of hypoxaemia', 'severe arterial desaturation']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation (procedure)'}, {'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration (observable entity)'}]","[{'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",65.0,0.0313533,"One minute after intubation and manual ventilation with 100% oxygen, the saturations of all patients returned to preinduction levels.","[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Khoo', 'Affiliation': 'Department of Anaesthesia, National University Hospital, Singapore.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Woo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ''}]","Annals of the Academy of Medicine, Singapore",[]
3102,31864809,Impact of Deep Learning-based Optimization Algorithm on Image Quality of Low-dose Coronary CT Angiography with Noise Reduction: A Prospective Study.,"RATIONALE AND OBJECTIVES


To evaluate deep learning (DL)-based optimization algorithm for low-dose coronary CT angiography (CCTA) image noise reduction and image quality (IQ) improvement.
MATERIALS AND METHODS


A postprocessing platform for the CCTA image was built using a DL-based algorithm. Seventy subjects referred for CCTA were randomly divided into two groups (study group A with 80 kVp and control group B with 100 kVp). Group C was obtained by DL optimization of group A. Subjective IQ was blindly graded by two experienced radiologists on a four-point scale (4-excellent,1-poor). The image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were calculated to evaluate IQ objectively. The difference between the time consumed of iterative reconstruction and DL algorithm was also recorded.
RESULTS


The subjective IQ score of group C using the DL algorithm was significantly better than that of group A (p = 0.005). The noise of group C was significantly decreased, while SNR and CNR were significantly increased compared to group A (p < 0.001). The subjective IQ scores were lower in group A compared to group B (p = 0.037), whereas subjective IQ scores in group C were not significantly different (p = 0.874). For objective IQ, the noise of group A was significantly higher, while SNR and CNR were significantly lower than that of group B (p < 0.05). There was no significant difference in noise and SNR between group C and group B (p > 0.05), but CNR in group C was significantly higher than that in group B (p < 0.05). The DL algorithm processes the image twice as fast as the iterative reconstruction speed.
CONCLUSION


The DL-based optimization algorithm could effectively improve the IQ of low-dose CCTA by noise reduction.",2020,"The subjective IQ scores were lower in group A compared to group B (p = 0.037), whereas subjective IQ scores in group C were not significantly different (p = 0.874).",['Seventy subjects referred for CCTA'],"['Deep Learning-based Optimization Algorithm', 'Low-dose Coronary CT Angiography with Noise Reduction', 'deep learning (DL)-based optimization algorithm for low-dose coronary CT angiography (CCTA']","['subjective IQ scores', 'SNR and CNR', 'noise and SNR', 'image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR', 'subjective IQ score']","[{'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",70.0,0.0118137,"The subjective IQ scores were lower in group A compared to group B (p = 0.037), whereas subjective IQ scores in group C were not significantly different (p = 0.874).","[{'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. Electronic address: wangyining@pumch.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'CT Business Unit, Neusoft Medical System Company, Shenyang, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Zhuoheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'CT Business Unit, Neusoft Medical System Company, Shenyang, China.'}, {'ForeName': 'Yumei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}]",Academic radiology,['10.1016/j.acra.2019.11.010']
3103,32011723,"Scale-up of the Kerala Diabetes Prevention Program (K-DPP) in Kerala, India: implementation evaluation findings.","The cluster-randomized controlled trial of the Kerala Diabetes Prevention Program (K-DPP) demonstrated some significant improvements in cardiometabolic risk factors and other outcomes. We aimed to refine and improve K-DPP for wider implementation in the Kerala state of India. The specific objectives of the scale-up program were (a) to develop a scalable program delivery model and related capacity building in Kerala and (b) to achieve significant improvements in cardiometabolic risk factors in the target population. A total of 118 key trainers of a large women's organization trained 15,000 peer leaders in three districts of Kerala. Each of these peer leaders was required to deliver 12 monthly sessions to ~25 people, reaching an estimated total of 375,000 adults over 12 months. We evaluated the number of sessions conducted, the participation of men, and program reach. We also assessed the effectiveness of the program in a random sample of 1,200 adults before and after the intervention and performed a biochemical evaluation on a subsample of 321. Of the 15,222 peer leaders who were trained, 1,475 (9.7%) returned their evaluation forms, of which, 98% reported conducting at least 1 session, 88% ≥6 sessions, and 74% all 12 sessions. Tobacco use among men reduced from 30% to 25% (p = .02) and alcohol use from 40% to 32% (p = .001). Overall, mean waist circumference reduced from 89.5 to 87.5 cm (p < .001). Although there were some study shortcomings, the approach to scale-up and its implementation was quite effective in reaching a large population in Kerala and there were also some significant improvements in key cardiometabolic risk factors following the 1 year intervention.",2020,Tobacco use among men reduced from 30% to 25% (p = .02) and alcohol use from 40% to 32% (p = .001).,"[""118 key trainers of a large women's organization trained 15,000 peer leaders in three districts of Kerala"", '1,200 adults before and after the intervention and performed a biochemical evaluation on a subsample of 321']",['Kerala Diabetes Prevention Program (K-DPP'],"['cardiometabolic risk factors', 'mean waist circumference', 'key cardiometabolic risk factors']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0443018', 'cui_str': 'Kerala (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0443018', 'cui_str': 'Kerala (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",375000.0,0.025321,Tobacco use among men reduced from 30% to 25% (p = .02) and alcohol use from 40% to 32% (p = .001).,"[{'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Ravindranath', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Nossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Sajitha', 'Initials': 'S', 'LastName': 'Balachandran', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Gomathyamma Krishnakurup', 'Initials': 'GK', 'LastName': 'Mini', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Kishori', 'Initials': 'K', 'LastName': 'Mahat', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kavumpurathu Raman', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}]",Translational behavioral medicine,['10.1093/tbm/ibz197']
3104,31323295,Biomarkers of insulin action during single soccer sessions before and after a 12-week training period in type 2 diabetes patients on a caloric-restricted diet.,"BACKGROUND


We investigated the biomarkers of insulin action as well as changes in free fatty acids and lactate concentration after an acute soccer session pre and post training with caloric-restricted diet versus diet alone in type 2 diabetes (T2D) patients.
METHODS


Fifty-one middle-aged (61.1 ± 6.4 years) T2D patients were randomly allocated to the soccer+diet group (SDG) or the diet group (DG). The control group comprised T2D patients observing a caloric-restricted diet who did not receive soccer training. Over 12 weeks, SDG performed 3 × 40 min per week of soccer training.
RESULTS


The first soccer session for SDG induced acute increases in blood lactate (1.4 ± 0.1-6.0 ± 0.7 mmol/l, P < 0.05) and glucagon levels (112.1 ± 6.2-142.9 ± 8.0 pg/ml, P < 0.05), whereas glucose and insulin levels remained unchanged. Moreover, this session showed suppressed insulin levels as well as higher free fatty acids, lactate levels and glucagon/insulin ratio compared to DG (p < 0.05). After 12 weeks, a baseline decrease was observed in glucagon, leptin and lactate levels in SDG and DG (p < 0.05), whereas HOMA-IR, Adipo-IR and glucose levels were lower only in SDG (p < 0.05). At the last soccer training session, the blood lactate response was significantly lower than for the first session (4.0 ± 0.4 vs 6.0 ± 0.7 mmol/l). At 48 h pre intervention, a decrease was observed in leptin levels (p < 0.05), which remained lower post intervention. The positive correlation between leptin and insulin, and the lower levels after training, could be attributed to the improved insulin sensitivity along with the weight loss observed in both groups (~3.4 kg for DG and 3.7 kg for SDG).
CONCLUSION


Acute soccer sessions markedly improved insulin action markers in T2D patients, while the cumulative effects enhanced insulin sensitivity and decreased risk factors associated with cardiovascular disease after 12 weeks of intervention better than caloric-restricted diet.",2019,"At 48 h pre intervention, a decrease was observed in leptin levels (p < 0.05), which remained lower post intervention.","['T2D patients', 'Fifty-one middle-aged (61.1\u202f±\u202f6.4\u202fyears', 'type 2 diabetes patients on a caloric-restricted diet']","['T2D patients observing a caloric-restricted diet who did not receive soccer training', 'soccer+diet group (SDG) or the diet group (DG']","['blood lactate', 'glucagon levels', 'suppressed insulin levels', 'HOMA-IR, Adipo-IR and glucose levels', 'insulin sensitivity', 'glucose and insulin levels', 'insulin action markers', 'glucagon, leptin and lactate levels in SDG and DG', 'leptin levels', 'blood lactate response', 'free fatty acids, lactate levels and glucagon/insulin ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0337437', 'cui_str': 'Glucagon test (procedure)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0131745,"At 48 h pre intervention, a decrease was observed in leptin levels (p < 0.05), which remained lower post intervention.","[{'ForeName': 'Maysa V', 'Initials': 'MV', 'LastName': 'de Sousa', 'Affiliation': 'Laboratory of Medical Investigation, LIM-18, Endocrinology Division, School of Medicine, University of São Paulo, Sao Paulo, Brazil. Electronic address: maysavsousa@gmail.com.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Fukui', 'Affiliation': 'Laboratory of Medical Investigation, LIM-18, Endocrinology Division, School of Medicine, University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University of Tennessee, 38163 Memphis, TN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Zouhal', 'Affiliation': 'Movement, Sport and Health Sciences Laboratory (M2S), UFR-STAPS, University of Rennes 2-ENS, Rennes, France.'}, {'ForeName': 'Maria Elizabeth R', 'Initials': 'MER', 'LastName': 'da Silva', 'Affiliation': 'Laboratory of Medical Investigation, LIM-18, Endocrinology Division, School of Medicine, University of São Paulo, Sao Paulo, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112618']
3105,31935166,Evaluation of the rural response system intervention to prevent violence against women: findings from a community-randomised controlled trial in the Central Region of Ghana.,"Background : Intimate partner violence (IPV) affects one in three women globally and undermines women's human rights, social and economic development, and health, hence the need for integrated interventions involving communities in its prevention. Objective : This community-randomised controlled trial evaluated the Rural Response System (RRS) intervention, which uses Community Based Action Teams to prevent IPV by raising awareness and supporting survivors, compared to no intervention. Methods : Two districts of the Central Region of Ghana were randomly allocated to each arm. Data were collected by repeated, randomly sampled, household surveys, conducted at baseline (2000 women, 2126 men) and 24 months later (2198 women, 2328 men). The analysis used a difference in difference (DID) approach, adjusted for age and exposure to violence in childhood. Results : In intervention communities, women's past year experience of sexual IPV reduced from 17.1% to 7.7% versus 9.3% to 8.0% in the control communities (DID = -9.3(95%CI; -17.5,-1.0), p = 0.030). The prevalence of past-year physical IPV among women in the intervention communities reduced from 16.5% to 8.3% versus 14.6% to 10.9% in the controls (DID = -4.2(-12,3.6), p = 0.289). The prevalence of severe IPV experienced by women reduced from 21.2% to 11.6% in intervention versus 17.3% to 11.4% in controls (DID = -3.7(-12.5,5.1), p = 0.408). The direction of impact of the intervention on violence perpetrated by men was more towards a reduction but changes were not statistically significant. Emotional IPV perpetration was significantly lower (DID = -15.0(-28.5, -1.7), p = 0.031). Women's depression scores and reports of male partner controlling behaviour significantly also reduced in the intervention arm compared to those in the control arm (DID = -4.8(-8.0,-1.5), p = 0.005; DID = -2.7(-3.3,-1.0), p = 0.002, respectively). Conclusion : Our findings indicate that the RRS intervention reduced women's experiences of IPV, depression, and partner controlling behaviour and some evidence of men's reported reductions in the perpetration of IPV. The RRS intervention warrants careful scale-up in Ghana and further research.",2020,"Women's depression scores and reports of male partner controlling behaviour significantly also reduced in the intervention arm compared to those in the control arm (DID = -4.8(-8.0,-1.5), p = 0.005; DID = -2.7(-3.3,-1.0), p = 0.002, respectively).","['household surveys, conducted at baseline (2000 women, 2126 men) and 24 months later (2198 women, 2328 men', 'violence against women', 'Two districts of the Central Region of Ghana']","['RRS intervention', 'rural response system intervention', 'Rural Response System (RRS) intervention', ' ']","['prevalence of past-year physical IPV', 'prevalence of severe IPV', 'Emotional IPV perpetration', 'sexual IPV', 'depression scores and reports of male partner controlling behaviour', 'IPV, depression, and partner controlling behaviour']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0454907', 'cui_str': 'Central region (geographic location)'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1831579', 'cui_str': 'Controlling behavior'}]",2328.0,0.0664216,"Women's depression scores and reports of male partner controlling behaviour significantly also reduced in the intervention arm compared to those in the control arm (DID = -4.8(-8.0,-1.5), p = 0.005; DID = -2.7(-3.3,-1.0), p = 0.002, respectively).","[{'ForeName': 'Deda', 'Initials': 'D', 'LastName': 'Ogum Alangea', 'Affiliation': 'Department of Population, Family and Reproductive Health, School of Public Health, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Adolphina A', 'Initials': 'AA', 'LastName': 'Addo-Lartey', 'Affiliation': 'Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Esnat D', 'Initials': 'ED', 'LastName': 'Chirwa', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Yandisa', 'Initials': 'Y', 'LastName': 'Sikweyiya', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Dorcas', 'Initials': 'D', 'LastName': 'Coker-Appiah', 'Affiliation': 'Gender Studies and Human Rights Documentation Centre, Accra, Ghana.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Richard M K', 'Initials': 'RMK', 'LastName': 'Adanu', 'Affiliation': 'Department of Population, Family and Reproductive Health, School of Public Health, University of Ghana, Accra, Ghana.'}]",Global health action,['10.1080/16549716.2019.1711336']
3106,32176166,Feasibility of a trauma quality-of-life follow-up clinic.,"BACKGROUND


Little effort has been made to address long-term quality of life, chronic pain (CP), posttraumatic stress disorder (PTSD), and functional disability in trauma survivors. This quality initiative was developed to determine feasibility of a coordinated, comprehensive, patient-centered follow-up clinic for those at risk for poor long-term outcomes.
METHODS


A convenience sample from 649 hospitalized trauma patients at a Midwestern level 1 trauma center between February 2018 and August 2018 was screened for risk of PTSD and CP. Thirty-six patients were randomized into a standard follow-up clinic (standard of care [SOC]) (2-week postdischarge surgical clinic) or a new trauma quality of life clinic (TQOL). The TQOL was developed to provide comprehensive care to patients at high risk for PTSD (Injured Trauma Survivor Score, ≥2) and/or CP (discharge pain score, ≥4). Trauma quality of life clinic included a nurse practitioner or surgeon (physician), psychologist, social worker, and physical therapist at 1-week post discharge. All providers saw the patient independently, developed a care plan collaboratively, and communicated the plan to the patient. The SOC involved a visit only with a nurse practitioner or surgeon (medical doctor). Measures of pain, PTSD, depression, quality of life, physical functioning, and life satisfaction were completed at time of the TQOL/SOC or over the phone.
RESULTS


There were no differences in demographics, readmissions, or emergency department visits after discharge between groups. However, no show rates were almost twice as high in SOC (40%) compared with TQOL (22%) and those in TQOL completed 23 additional psychology visits versus one psychology visit in SOC. This clinic structure is feasible for high-risk patients, and TQOL patients demonstrated improved engagement in their care.
CONCLUSIONS


A comprehensive multidisciplinary TQOL addressing issues affecting convalescence for trauma patients at high risk for developing PTSD and CP can improve follow-up rates to ensure patients are recovering successfully.
LEVEL OF EVIDENCE


Therapeutic, Level IV.",2020,"There were no differences in demographics, readmissions, or emergency department visits after discharge between groups.","['trauma patients', '36 patients', '649 hospitalized trauma patients at a Midwestern level 1 trauma center between 2/2018 and 8/2018 was screened for risk of PTSD and CP', 'high risk patients and TQOL patients']","['standard follow-up clinic (SOC) (2-week post-discharge surgical clinic) or a new trauma quality of life clinic (TQOL', 'TQOL']","['TQOL included a nurse practitioner or surgeon(NP/MD), psychologist, social worker, and physical therapist', 'pain, PTSD, depression, QOL, physical functioning, and life satisfaction', 'demographics, readmissions, or emergency department visits']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034380'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",36.0,0.0384627,"There were no differences in demographics, readmissions, or emergency department visits after discharge between groups.","[{'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Trevino', 'Affiliation': 'From the Department of Surgery, Division of Trauma and Acute Care Surgery, Medical College of Wisconsin (C.T., T.G., D.J.M., P.C., T.d.-C.); Department of Psychology, Marquette University (S.C.T.-M.); and Froedtert Lutheran Memorial Hospital (M.S.), Milwaukee, Wisconsin.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Geier', 'Affiliation': ''}, {'ForeName': 'Sydney C', 'Initials': 'SC', 'LastName': 'Timmer-Murillo', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Shawlin', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Milia', 'Affiliation': ''}, {'ForeName': 'Panna', 'Initials': 'P', 'LastName': 'Codner', 'Affiliation': ''}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'deRoon-Cassini', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002672']
3107,31993753,Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial.,"PURPOSE


To evaluate the feasibility of oral cryotherapy (OC) in children and to investigate if OC reduces the incidence of severe oral mucositis (OM), oral pain, and opioid use in children undergoing hematopoietic stem cell transplantation (HSCT).
METHODS


Fifty-three children, 4-17 years old, scheduled for HSCT in Sweden were included and randomized to OC or control using a computer-generated list. OC instructions were to cool the mouth with ice for as long as possible during chemotherapy infusions with an intended time of ≥ 30 min. Feasibility criteria in the OC group were as follows: (1) compliance ≥ 70%; (2) considerable discomfort during OC < 20%; (3) no serious adverse events; and (4) ice administered to all children. Grade of OM and oral pain was recorded daily using the WHO-Oral Toxicity Scale (WHO-OTS), Children's International Oral Mucositis Evaluation Scale, and Numerical Rating Scale. Use of opioids was collected from the medical records.
RESULTS


Forty-nine children (mean age 10.5 years) were included in analysis (OC = 26, control = 23). The feasibility criteria were not met. Compliance was poor, especially for the younger children, and only 15 children (58%) used OC as instructed. Severe OM (WHO-OTS ≥ 3) was recorded in 26 children (OC = 15, control = 11). OC did not reduce the incidence of severe OM, oral pain, or opioid use.
CONCLUSION


The feasibility criteria were not met, and the RCT could not show that OC reduces the incidence of severe OM, oral pain, or opioid use in pediatric patients treated with a variety of conditioning regimens for HSCT.
TRIAL REGISTRATION


ClinicalTrials.gov id: NCT01789658.",2020,"OC did not reduce the incidence of severe OM, oral pain, or opioid use.
","['Forty-nine children (mean age 10.5\xa0years', 'children undergoing hematopoietic stem cell transplantations', 'Fifty-three children, 4-17\xa0years old, scheduled for HSCT in Sweden', 'children undergoing hematopoietic stem cell transplantation (HSCT']","['oral cryotherapy (OC', 'OC or control using a computer-generated list', 'cryotherapy']","['severe OM, oral pain', 'incidence of severe OM, oral pain, or opioid use', 'Grade of OM and oral pain', ""WHO-Oral Toxicity Scale (WHO-OTS), Children's International Oral Mucositis Evaluation Scale, and Numerical Rating Scale"", 'severe oral mucositis (OM), oral pain, and opioid use']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1142072', 'cui_str': 'Oral toxicity'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",53.0,0.0556696,"OC did not reduce the incidence of severe OM, oral pain, or opioid use.
","[{'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Kamsvåg', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden. tove.kamsvag_magnusson@kbh.uu.se.""}, {'ForeName': 'Anncarin', 'Initials': 'A', 'LastName': 'Svanberg', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Karin Garming', 'Initials': 'KG', 'LastName': 'Legert', 'Affiliation': 'Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Arvidson', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'von Essen', 'Affiliation': ""Department of Women's and Children's Health, Clinical Psychology in Healthcare, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mellgren', 'Affiliation': 'Department of Pediatric Oncology, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Toporski', 'Affiliation': 'Department of Clinical Sciences, Pediatric Oncology and Hematology, University of Lund, Lund, Sweden.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Winiarski', 'Affiliation': ""Department of Pediatrics, Astrid Lindgren's Children's Hospital, Karolinska University Hospital, Huddinge, Stockholm, Sweden.""}, {'ForeName': 'Gustaf', 'Initials': 'G', 'LastName': 'Ljungman', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05258-2']
3108,32188915,Neuroprotection with rasagiline in patients with macula-off retinal detachment: A randomized controlled pilot study.,"We aimed to evaluate the neuroprotective efficacy of rasagiline in pseudophakic patients who had surgery for macula-off rhegmatogenous retinal detachment (RRD). This was a 6-month, prospective, randomized, double-blind, placebo-controlled pilot study. Patients presenting with acute macula-off RRD were recruited and randomized 1:1 to receive rasagiline 1 mg/day or placebo for 7 days. Best-corrected visual acuity (BCVA) and optical coherence tomography were acquired 1 day before as well as 2 days, 3 weeks, 3 months and 6 months after surgery. We screened 26 patients with RRD whereof 23 were eventually included and randomized. The primary outcome was final BCVA. Secondary outcomes included central retinal thickness (CRT) and adverse events (AE). We evaluated photoreceptor cells (prc) recovery through morphological measurements. The baseline characteristics were comparable between groups. BCVA significantly improved in both groups (letters gained: rasagiline 61.5 ± 18.1 vs placebo 55.3 ± 29.2, p = 0.56), but no significant inter-group difference was found at any visit. CRT was stable 3 weeks after surgery onwards, with no inter-group difference. No treatment-emergent AE occurred. Significant prc restoration was observed from 3 weeks to 6 months after surgery, without inter-group difference at either visit. Ellipsoid zone integrity (β = 0.517, p = 0.008) and foveal bulge (β = 0.387, p = 0.038) were significant predictors of good final BCVA. In conclusion, perioperative oral treatment with rasagiline 1 mg/day for 7 days did not show significant benefits on visual or anatomical outcomes in macula-off RRD patients.",2020,"BCVA significantly improved in both groups (letters gained: rasagiline 61.5 ± 18.1 vs placebo 55.3 ± 29.2, p = 0.56), but no significant inter-group difference was found at any visit.","['pseudophakic patients who had surgery for macula-off rhegmatogenous retinal detachment (RRD', 'patients with macula-off retinal detachment', 'Patients presenting with acute macula-off RRD', '26 patients with RRD whereof 23 were eventually included and randomized']","['Neuroprotection with rasagiline', 'rasagiline', 'rasagiline 1\u2009mg/day or placebo', 'placebo']","['Significant prc restoration', 'final BCVA', 'Best-corrected visual acuity (BCVA) and optical coherence tomography', 'BCVA', 'Ellipsoid zone integrity', 'CRT', 'central retinal thickness (CRT) and adverse events (AE', 'visual or anatomical outcomes', 'foveal bulge', 'neuroprotective efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332573', 'cui_str': 'Macule (morphologic abnormality)'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0598958', 'cui_str': 'Neuronal Protection'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C1638357', 'cui_str': 'rasagiline 1 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}]",26.0,0.711981,"BCVA significantly improved in both groups (letters gained: rasagiline 61.5 ± 18.1 vs placebo 55.3 ± 29.2, p = 0.56), but no significant inter-group difference was found at any visit.","[{'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Framme', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marcel Nico', 'Initials': 'MN', 'LastName': 'Menke', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lieselotte Erika', 'Initials': 'LE', 'LastName': 'Berger', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin Sebastian', 'Initials': 'MS', 'LastName': 'Zinkernagel', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marion Rohit', 'Initials': 'MR', 'LastName': 'Munk', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ebneter', 'Affiliation': 'Department of Ophthalmology and Department of Clinical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. ebneter.andreas@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-61835-0']
3109,32030910,Examining Heterogeneity of Outcomes in a Weight Gain Prevention Program for Young Adults.,"OBJECTIVE


This study aimed to characterize young adults who experienced significant weight gains (> 10%) over 3 years in a weight gain prevention program.
METHODS


Secondary data analysis from the Study of Novel Approaches to Weight Gain Prevention (SNAP), a randomized trial comparing two self-regulation interventions and a control arm in young adults (18-35 years; BMI 21-30.9 kg/m 2  ), was used. Large Gainers (≥ 10% of their body weight; n = 48), Small Gainers (2.6%-9.9%; n = 149), and Weight Stable participants (± 2.5%; n = 143) were compared on dimensions affecting weight gain.
RESULTS


Differences in weight gain among the three groups were significant by year 1 and subsequently increased. Those who became Large Gainers were heavier at baseline and further below their highest weight, and they reported more weight cycling than Weight Stable, with Small Gainers intermediate. Neither study arm nor pregnancy explained weight change differences among the three groups. Large Gainers reported more depressive symptoms than Weight Stable at years 1 and 2. Large Gainers were less likely to weigh themselves at least weekly at 4 months, before differences in weight gain emerged, and at years 1 and 2.
CONCLUSIONS


Large Gainers (representing almost 10% of participants) could be identified early by greater weight issues at baseline and lower use of weight gain prevention strategies.",2020,"Large Gainers were less likely to weigh themselves at least weekly at 4 months, before differences in weight gain emerged, and at years 1 and 2.
","['young adults who experienced significant weight gains (>\u200910%) over 3 years in a weight gain prevention program', 'young adults (18-35 years; BMI 21-30.9 kg/m 2  ', 'Young Adults']","['self-regulation interventions', 'Weight Gain Prevention Program', 'Weight Gain Prevention (SNAP']","['weight gain', 'depressive symptoms', 'weight cycling']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0074709', 'cui_str': 'Snap (resin)'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0385731,"Large Gainers were less likely to weigh themselves at least weekly at 4 months, before differences in weight gain emerged, and at years 1 and 2.
","[{'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Health, Behavior, and Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gorin', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Letitia H', 'Initials': 'LH', 'LastName': 'Perdue', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bahnson', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Polzien', 'Affiliation': 'Department of Health, Behavior, and Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Ferguson Robichaud', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22720']
3110,31345044,Tailored Helicobacter pylori eradication based on prior intake of macrolide antibiotics allows the use of triple therapy with optimal results in an area with high clarithromycin resistance.,"BACKGROUND


the previous intake of macrolide antibiotics is associated with a failure to eradicate Helicobacter pylori (H. pylori) with clarithromycin-containing regimens. However, the standard triple therapy achieves eradication rates of over 90% in patients without a previous use of macrolides in our health area. The aim of this study was to evaluate the efficacy of an H. pylori eradication strategy based on the intake of macrolides by the patient during the previous years.
METHODS


one hundred and sixty-nine patients with H. pylori infection were prospectively included in the study. The electronic medical record of each patient was reviewed at the time of inclusion. Depending on their previous intake of macrolides, patients were assigned to one of two eradication regimens: group A) patients without a previous intake of macrolides received an optimized triple therapy for 14 days; and group B) patients with a previous intake of macrolides received bismuth quadruple therapy for ten days.
RESULTS


ninety-one patients (53.84%) without a previous intake of macrolides received an optimized triple therapy (group A) and 78 patients (46.15%) with a previous intake of macrolides received bismuth quadruple therapy (group B). In group A, the H. pylori eradication rates were 90.11% in the intention-to-treat and 95.35% in the per-protocol analysis. In group B, the H. pylori eradication rates were 85.89% in the intention-to-treat and 98.5% in the per-protocol analysis. The overall eradication rates obtained using this strategy were 88.16% (95% CI: 82.32-92.02%) in the intention-to-treat and 96.75% (95% CI: 92.59-98.94%) in the per-protocol analysis.
CONCLUSIONS


an H. pylori eradication strategy based on the intake of macrolides during the previous years achieves overall eradication rates close to 90% and allows the use of standard triple therapy in more than half of the patients from a health area with a high level of clarithromycin resistance.",2019,"The overall eradication rates obtained using this strategy were 88.16% (95% CI: 82.32-92.02%) in the intention-to-treat and 96.75% (95% CI: 92.59-98.94%) in the per-protocol analysis.
","['ninety-one patients (53.84%) without a previous intake of macrolides received an', 'one hundred and sixty-nine patients with H. pylori infection were prospectively included in the study']","['optimized triple therapy', 'macrolide antibiotics', 'bismuth quadruple therapy', 'clarithromycin']","['pylori eradication rates', 'overall eradication rates', 'eradication rates']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",169.0,0.038579,"The overall eradication rates obtained using this strategy were 88.16% (95% CI: 82.32-92.02%) in the intention-to-treat and 96.75% (95% CI: 92.59-98.94%) in the per-protocol analysis.
","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Valle Muñoz', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo, España.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Muñoz Gómez', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Sierra Bernal', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo, ESPAÑA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'de Andrés', 'Affiliation': 'Universidad Jaume I .'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Gómez Hernando', 'Affiliation': 'Microbiología, Complejo Hospitalario de Toledo.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gómez Rodríguez', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo, ESPAÑA.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2019.6198/2019']
3111,31993736,Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial.,"BACKGROUND


The randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase.
METHODS


Eight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints.
RESULTS


One-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009).
CONCLUSIONS


The clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group.
CLINICAL TRIAL REGISTRATION


www.clinicaltrials.gov ; number, NCT01574534.",2020,"Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009).
","['patients undergoing a clinically indicated follow-up angiography during the study phase', 'patients undergoing', 'Eight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel\u2009<\u20093\xa0mm in diameter for stable coronary artery disease or acute coronary syndrome', 'small coronary artery lesions']","['drug-coated balloon (DCB', 'percutaneous coronary intervention (PCI', 'drug-eluting stents (DES', 'Drug-coated balloon versus drug-eluting stent']","['Complete thrombotic vessel occlusions', 'complete occlusion of the target lesion', 'mean reference vessel diameter', 'LL', 'lumen loss (LL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",883.0,0.183424,"Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009).
","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Fahrni', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scheller', 'Affiliation': 'Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gilgen', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farah', 'Affiliation': 'Knappschaftskrankenhaus, Klinikum Westfalen, Dortmund, Germany.'}, {'ForeName': 'Marc-Alexander', 'Initials': 'MA', 'LastName': 'Ohlow', 'Affiliation': 'Central Clinic, Bad Berka, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Mangner', 'Affiliation': 'Heart Center Dresden at the Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weilenmann', 'Affiliation': 'Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Florim', 'Initials': 'F', 'LastName': 'Cuculi', 'Affiliation': 'Kantonsspital Luzern, Luzern, Switzerland.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leibundgut', 'Affiliation': 'Kantonsspital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Möbius-Winkler', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zweiker', 'Affiliation': 'University Hospital Graz, Graz, Austria.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Twerenbold', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland. raban.jeger@usb.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01603-2']
3112,32199491,"Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.","BACKGROUND


The 2014 Zaire Ebola virus disease epidemic accelerated vaccine development for the virus. We aimed to assess the safety, reactogenicity, and immunogenicity of one dose of monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in adults.
METHODS


This phase 2, randomised, observer-blind, controlled trial was done in study centres in Cameroon, Mali, Nigeria, and Senegal. Healthy adults (≥18 years) were randomly assigned with a web-based system (1:1; minimisation procedure accounting for age, gender, centre) to receive ChAd3-EBO-Z (day 0), or saline placebo (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind until planned interim day 30 analysis, single-blind until month 6, and open-label after month 6 vaccination. Primary outcomes assessed in the total vaccinated cohort, which comprised all participants with at least one study dose administration documented, were serious adverse events (up to study end, month 12); and for a subcohort were solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02485301.
FINDINGS


Between July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504 [49·9%] in the placebo/ChAd3-EBO-Z group), 17 were excluded because no vaccine was administered. The most common solicited injection site symptom was pain (356 [48%] of 748 in the ChAd3-EBO-Z group vs 57 [8%] of 751 in the placebo/ChAd3-EBO-Z group); the most common solicited general adverse event was headache (345 [46%] in the ChAd3-EBO-Z group vs 136 [18%] in the placebo/ChAd3-EBO-Z group). Unsolicited adverse events were reported by 123 (16%) of 749 in the ChAd3-EBO-Z group and 119 (16%) of 751 in the placebo/ChAd3-EBO-Z group. Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group; none were considered vaccination-related. No clinically meaningful thrombocytopenia was reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentration was 900 (95% CI 824-983) in the ChAd3-EBO-Z group. There were no treatment-related deaths.
INTERPRETATION


ChAd3-EBO-Z was immunogenic and well tolerated in adults. Our findings provide a strong basis for future development steps, which should concentrate on multivalent approaches (including Sudan and Marburg strains). Additionally, prime-boost approaches should be a focus with a ChAd3-based vaccine for priming and boosted by a modified vaccinia Ankara-based vaccine.
FUNDING


EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.",2020,"Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group;","['adults in Africa', 'adults', 'Healthy adults (≥18 years', 'study centres in Cameroon, Mali, Nigeria, and Senegal', 'Between July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504']","['placebo', 'monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z', 'chimpanzee adenovirus vectored Ebola vaccine', 'ChAd3-EBO-Z (day 0), or saline placebo']","['unsolicited adverse events', 'solicited local or general adverse events', 'Serious adverse events', 'meaningful thrombocytopenia', 'Safety, reactogenicity, and immunogenicity', 'serious adverse events', 'Unsolicited adverse events', 'safety, reactogenicity, and immunogenicity', 'Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination', 'haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia', 'headache']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0486729', 'cui_str': 'Ebola virus antibody'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",3030.0,0.541374,"Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group;","[{'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mtapia@som.umaryland.edu.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Birahim P', 'Initials': 'BP', 'LastName': 'Ndiaye', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Khardiata D', 'Initials': 'KD', 'LastName': 'Mbaye', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Aliou', 'Initials': 'A', 'LastName': 'Thiongane', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Cheikh T', 'Initials': 'CT', 'LastName': 'Ndour', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Mboup', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Ake', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Babajide', 'Initials': 'B', 'LastName': 'Keshinro', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Gideon A', 'Initials': 'GA', 'LastName': 'Akintunde', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Thompson N', 'Initials': 'TN', 'LastName': 'Kinge', 'Affiliation': 'Bamenda Regional Hospital, Bamenda, Cameroon.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vernet', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Jean Joel', 'Initials': 'JJ', 'LastName': 'Bigna', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Oguche', 'Affiliation': 'University of Jos & Jos University Teaching Hospital, Jos, Nigeria.'}, {'ForeName': 'Kwadwo A', 'Initials': 'KA', 'LastName': 'Koram', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Wayne R', 'Initials': 'WR', 'LastName': 'Hogrefe', 'Affiliation': 'Q(2) Solutions, San Juan Capistrano, CA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Günther', 'Affiliation': 'Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.'}, {'ForeName': 'Abdi', 'Initials': 'A', 'LastName': 'Naficy', 'Affiliation': 'Quintiles, La Défense Cedex, France.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Debois', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bourguignon', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30016-5']
3113,32199492,"Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.","BACKGROUND


During the large 2013-16 Ebola virus outbreak caused by the Zaire Ebola virus, about 20% of cases were reported in children. This study is the first, to our knowledge, to evaluate an Ebola vaccine in children younger than 6 years. We aimed to evaluate the safety, reactogenicity, and immunogenicity of a monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in a paediatric population.
METHODS


This phase 2, randomised, observer-blind, controlled trial was done in a vaccine centre in Mali and a university hospital centre in Senegal. Healthy children were randomly assigned through a web-based system (1:1; stratified by age group, gender, and centre) to receive ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind from study start until interim day 30 analysis and became single-blind as of interim analysis. Primary outcomes assessed were serious adverse events (up to study end, month 12), solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). As secondary endpoints, we evaluated anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02548078.
FINDINGS


From Nov 11, 2015, to May 9, 2016, of 776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the ChAd3-EBO-Z/MenACWY-TT group and 300 (50%) to the MenACWY-TT/ChAd3-EBO-Z group; all were included in the total vaccinated cohort. Post-day 0 vaccination, the most common solicited injection site symptom was pain (127 [42%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 60 [20%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group); the most common solicited general adverse event was fever (95 [32%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 28 [9%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group). Unsolicited adverse events post-day 0 vaccination were reported by 41 (14%) of 300 participants in the ChAd3-EBO-Z/MenACWY-TT group and 24 (8%) of 300 MenACWY-TT/ChAd3-EBO-Z recipients. Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related. No clinical symptoms of thrombocytopenia were reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentrations (GMC) in the ChAd3-EBO-Z/MenACWY-TT group were 1564 (95% CI 1340-1826) for those aged 13-17 years, 1395 (1175-1655) for 6-12 years, and 2406 (1942-2979) for 1-5 years. Anti-glycoprotein Ebola virus IgG antibody responses persisted up to 12 months post-vaccination, with a GMC of 716 (95% CI 619-828) for those aged 13-17 years, 752 (645-876) for 6-12 years, and 1424 (1119-1814) for 1-5 years.
INTERPRETATION


ChAd3-EBO-Z was immunogenic and well tolerated in children aged 1-17 years. This study provides the first ChAd3-EBO-Z data in a paediatric population. Further development should focus on multivalent approaches including Sudan and Marburg strains, and heterologous prime-boost strategies, for instance using modified vaccinia Ankara-based vaccine to boost the immune response.
FUNDING


EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.",2020,Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related.,"['vaccine centre in Mali and a university hospital centre in Senegal', 'Healthy children', 'children younger than 6 years', 'children in Africa', 'children aged 1-17 years', 'paediatric population', '776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the']","['ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT', 'ChAd3-EBO-Z/MenACWY-TT', 'placebo', 'monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z', 'chimpanzee adenovirus vectored Ebola vaccine', 'Ebola vaccine']","['clinical symptoms of thrombocytopenia', 'solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia', 'Serious adverse events', 'Safety, reactogenicity, and immunogenicity', 'serious adverse events', 'safety, reactogenicity, and immunogenicity', 'anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination']","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0949896', 'cui_str': 'Zaire Ebola Virus'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.236911,Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related.,"[{'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mtapia@som.umaryland.edu.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Khardiata D', 'Initials': 'KD', 'LastName': 'Mbaye', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Aliou', 'Initials': 'A', 'LastName': 'Thiongane', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Birahim P', 'Initials': 'BP', 'LastName': 'Ndiaye', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Cheikh T', 'Initials': 'CT', 'LastName': 'Ndour', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Mboup', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Babajide', 'Initials': 'B', 'LastName': 'Keshinro', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Thompson N', 'Initials': 'TN', 'LastName': 'Kinge', 'Affiliation': 'Bamenda Regional Hospital, Bamenda, Cameroon.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vernet', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Jean Joel', 'Initials': 'JJ', 'LastName': 'Bigna', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Oguche', 'Affiliation': 'University of Jos and Jos University Teaching Hospital, Jos, Nigeria.'}, {'ForeName': 'Kwadwo A', 'Initials': 'KA', 'LastName': 'Koram', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Quintiles, La Defense Cedex, France.'}, {'ForeName': 'Wayne R', 'Initials': 'WR', 'LastName': 'Hogrefe', 'Affiliation': 'Q(2) Solutions, San Juan Capistrano, CA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Debois', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bourguignon', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30019-0']
3114,31664429,Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.,"Importance


It is unclear whether levothyroxine treatment provides clinically important benefits in adults aged 80 years and older with subclinical hypothyroidism.
Objective


To determine the association of levothyroxine treatment for subclinical hypothyroidism with thyroid-related quality of life in adults aged 80 years and older.
Design, Setting, and Participants


Prospectively planned combined analysis of data involving community-dwelling adults aged 80 years and older with subclinical hypothyroidism. Data from a randomized clinical trial were combined with a subgroup of participants aged 80 years and older from a second clinical trial. The trials were conducted between April 2013 and May 2018. Final follow-up was May 4, 2018.
Exposures


Participants were randomly assigned to receive levothyroxine (n = 112; 52 participants from the first trial and 60 from the second trial) or placebo (n = 139; 53 participants from the first trial and 86 from the second trial).
Main Outcomes and Measures


Co-primary outcomes were Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire scores for the domains of hypothyroid symptoms and tiredness at 1 year (range, 0-100; higher scores indicate worse quality of life; minimal clinically important difference, 9).
Results


Of 251 participants (mean age, 85 years; 118 [47%] women), 105 were included from the first clinical trial and 146 were included from the second clinical trial. A total of 212 participants (84%) completed the study. The hypothyroid symptoms score decreased from 21.7 at baseline to 19.3 at 12 months in the levothyroxine group vs from 19.8 at baseline to 17.4 at 12 months in the placebo group (adjusted between-group difference, 1.3 [95% CI, -2.7 to 5.2]; P = .53). The tiredness score increased from 25.5 at baseline to 28.2 at 12 months in the levothyroxine group vs from 25.1 at baseline to 28.7 at 12 months in the placebo group (adjusted between-group difference, -0.1 [95% CI, -4.5 to 4.3]; P = .96). At least 1 adverse event occurred in 33 participants (29.5%) in the levothyroxine group (the most common adverse event was cerebrovascular accident, which occurred in 3 participants [2.2%]) and 40 participants (28.8%) in the placebo group (the most common adverse event was pneumonia, which occurred in 4 [3.6%] participants).
Conclusions and Relevance


In this prospectively planned analysis of data from 2 clinical trials involving adults aged 80 years and older with subclinical hypothyroidism, treatment with levothyroxine, compared with placebo, was not significantly associated with improvement in hypothyroid symptoms or fatigue. These findings do not support routine use of levothyroxine for treatment of subclinical hypothyroidism in adults aged 80 years and older.
Trial Registration


ClinicalTrials.gov Identifier: NCT01660126; Netherlands Trial Register: NTR3851.",2019,"The tiredness score increased from 25.5 at baseline to 28.2 at 12 months in the levothyroxine group vs from 25.1 at baseline to 28.7 at 12 months in the placebo group (adjusted between-group difference, -0.1 [95% CI, -4.5 to 4.3]; P = .96).","['adults aged 80 years and older with subclinical hypothyroidism', 'adults aged 80 years and older with subclinical hypothyroidism, treatment with', '251 participants (mean age, 85 years; 118 [47%] women', ' 105 were included from the first clinical trial and 146 were included from the second clinical trial', 'A total of 212 participants (84%) completed the study', 'adults aged 80 years and older', 'participants aged 80 years and older from a second clinical trial', 'Adults Aged 80 Years and Older With Subclinical Hypothyroidism', 'subclinical hypothyroidism with thyroid-related quality of life in adults aged 80 years and older', 'Exposures\n\n\nParticipants', 'community-dwelling adults aged 80 years and older with subclinical hypothyroidism', 'n\u2009=\u2009112; 52 participants from the first trial and 60 from the second trial) or', 'n\u2009=\u2009139; 53 participants from the first trial and 86 from the second trial']","['placebo', 'Levothyroxine', 'levothyroxine']","['Measures\n\n\nCo-primary outcomes were Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire scores for the domains of hypothyroid symptoms and tiredness', 'hypothyroid symptoms score', 'tiredness score', 'hypothyroid symptoms or fatigue', 'quality of life; minimal clinically important difference, 9']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0034380'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0034380'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}]",251.0,0.634016,"The tiredness score increased from 25.5 at baseline to 28.2 at 12 months in the levothyroxine group vs from 25.1 at baseline to 28.7 at 12 months in the placebo group (adjusted between-group difference, -0.1 [95% CI, -4.5 to 4.3]; P = .96).","[{'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Mooijaart', 'Affiliation': 'Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Du Puy', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Rudi G J', 'Initials': 'RGJ', 'LastName': 'Westendorp', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Wendy P J', 'Initials': 'WPJ', 'LastName': 'den Elzen', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Postmus', 'Affiliation': 'Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Rosalinde K E', 'Initials': 'RKE', 'LastName': 'Poortvliet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'van Heemst', 'Affiliation': 'Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'van Munster', 'Affiliation': 'Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Peeters', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kean', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Claudia-Martina', 'Initials': 'CM', 'LastName': 'Messow', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Department of Internal Medicine, Copenhagen University Hospital Herlev, Gentofte, Denmark.'}, {'ForeName': 'Olaf M', 'Initials': 'OM', 'LastName': 'Dekkers', 'Affiliation': 'Department of Endocrinology and Metabolic Disorders, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA,['10.1001/jama.2019.17274']
3115,31810865,Biomarker-guided antibiotic stewardship in suspected ventilator-associated pneumonia (VAPrapid2): a randomised controlled trial and process evaluation.,"BACKGROUND


Ventilator-associated pneumonia is the most common intensive care unit (ICU)-acquired infection, yet accurate diagnosis remains difficult, leading to overuse of antibiotics. Low concentrations of IL-1β and IL-8 in bronchoalveolar lavage fluid have been validated as effective markers for exclusion of ventilator-associated pneumonia. The VAPrapid2 trial aimed to determine whether measurement of bronchoalveolar lavage fluid IL-1β and IL-8 could effectively and safely improve antibiotic stewardship in patients with clinically suspected ventilator-associated pneumonia.
METHODS


VAPrapid2 was a multicentre, randomised controlled trial in patients admitted to 24 ICUs from 17 National Health Service hospital trusts across England, Scotland, and Northern Ireland. Patients were screened for eligibility and included if they were 18 years or older, intubated and mechanically ventilated for at least 48 h, and had suspected ventilator-associated pneumonia. Patients were randomly assigned (1:1) to biomarker-guided recommendation on antibiotics (intervention group) or routine use of antibiotics (control group) using a web-based randomisation service hosted by Newcastle Clinical Trials Unit. Patients were randomised using randomly permuted blocks of size four and six and stratified by site, with allocation concealment. Clinicians were masked to patient assignment for an initial period until biomarker results were reported. Bronchoalveolar lavage was done in all patients, with concentrations of IL-1β and IL-8 rapidly determined in bronchoalveolar lavage fluid from patients randomised to the biomarker-based antibiotic recommendation group. If concentrations were below a previously validated cutoff, clinicians were advised that ventilator-associated pneumonia was unlikely and to consider discontinuing antibiotics. Patients in the routine use of antibiotics group received antibiotics according to usual practice at sites. Microbiology was done on bronchoalveolar lavage fluid from all patients and ventilator-associated pneumonia was confirmed by at least 10 4  colony forming units per mL of bronchoalveolar lavage fluid. The primary outcome was the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage. Data were analysed on an intention-to-treat basis, with an additional per-protocol analysis that excluded patients randomly assigned to the intervention group who defaulted to routine use of antibiotics because of failure to return an adequate biomarker result. An embedded process evaluation assessed factors influencing trial adoption, recruitment, and decision making. This study is registered with ISRCTN, ISRCTN65937227, and ClinicalTrials.gov, NCT01972425.
FINDINGS


Between Nov 6, 2013, and Sept 13, 2016, 360 patients were screened for inclusion in the study. 146 patients were ineligible, leaving 214 who were recruited to the study. Four patients were excluded before randomisation, meaning that 210 patients were randomly assigned to biomarker-guided recommendation on antibiotics (n=104) or routine use of antibiotics (n=106). One patient in the biomarker-guided recommendation group was withdrawn by the clinical team before bronchoscopy and so was excluded from the intention-to-treat analysis. We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58). Bronchoalveolar lavage was associated with a small and transient increase in oxygen requirements. Established prescribing practices, reluctance for bronchoalveolar lavage, and dependence on a chain of trial-related procedures emerged as factors that impaired trial processes.
INTERPRETATION


Antibiotic use remains high in patients with suspected ventilator-associated pneumonia. Antibiotic stewardship was not improved by a rapid, highly sensitive rule-out test. Prescribing culture, rather than poor test performance, might explain this absence of effect.
FUNDING


UK Department of Health and the Wellcome Trust.",2020,We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58).,"['patients admitted to 24 ICUs from 17 National Health Service hospital trusts across England, Scotland, and Northern Ireland', 'patients with suspected ventilator-associated pneumonia', 'Patients were screened for eligibility and included if they were 18 years or older, intubated and mechanically ventilated for at least 48 h, and had suspected ventilator-associated pneumonia', 'Between Nov 6, 2013, and Sept 13, 2016, 360 patients were screened for inclusion in the study', 'suspected ventilator-associated pneumonia (VAPrapid2', 'Four patients were excluded before randomisation, meaning that 210 patients', '146 patients were ineligible, leaving 214 who were recruited to the study', 'patients with clinically suspected ventilator-associated pneumonia']","['biomarker-guided recommendation on antibiotics (intervention group) or routine use of antibiotics (control group) using a web-based randomisation service hosted by Newcastle Clinical Trials Unit', 'biomarker-guided recommendation on antibiotics (n=104) or routine use of antibiotics', 'Biomarker-guided antibiotic stewardship']","['oxygen requirements', 'distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage', 'Antibiotic stewardship']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]",146.0,0.342377,We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58).,"[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Hellyer', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK; Regional Intensive Care Unit, The Royal Hospitals, Belfast, UK.""}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Walsh', 'Affiliation': ""Anaesthesia, Critical Care and Pain Medicine, University of Edinburgh, Queen's Medical Research Institute, Edinburgh, UK; Intensive Care Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Conway Morris', 'Affiliation': ""Division of Anaesthesia, Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Suveer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Cancer and Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dark', 'Affiliation': 'Division of Infection Immunity and Respiratory Medicine, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Alistair I', 'Initials': 'AI', 'LastName': 'Roy', 'Affiliation': 'Integrated Critical Care Unit, Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK; Intensive Care Unit, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'McMullan', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Emerson', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Integrated Critical Care Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Kefala', 'Affiliation': 'Intensive Care Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': ""O'Kane"", 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Simon V', 'Initials': 'SV', 'LastName': 'Baudouin', 'Affiliation': 'Intensive Care Unit, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Paterson', 'Affiliation': 'Intensive Care Unit, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rostron', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK; Integrated Critical Care Unit, Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bannard-Smith', 'Affiliation': 'Intensive Care Unit, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Robin', 'Affiliation': 'Intensive Care Unit, Countess of Chester NHS Foundation Trust, Chester, UK.'}, {'ForeName': 'Ingeborg D', 'Initials': 'ID', 'LastName': 'Welters', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bassford', 'Affiliation': 'Intensive Care Unit, University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Yates', 'Affiliation': 'Intensive Care Unit, Northumbria Specialist Emergency Care Hospital, Cramlington, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Spencer', 'Affiliation': 'Intensive Care Unit, Preston Royal Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Shondipon K', 'Initials': 'SK', 'LastName': 'Laha', 'Affiliation': 'Intensive Care Unit, Preston Royal Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hulme', 'Affiliation': 'Intensive Care Unit, Sandwell General Hospital, Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bonner', 'Affiliation': 'Intensive Care Unit, James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Linnett', 'Affiliation': 'Intensive Care Unit, Queen Elizabeth Hospital, Gateshead NHS Foundation Trust, Gateshead, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sonksen', 'Affiliation': 'Intensive Care Unit, Russells Hall Hospital, Dudley Group NHS Foundation Trust, Dudley, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Van Den Broeck', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Boschman', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Dw James', 'Initials': 'DJ', 'LastName': 'Keenan', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'A Joy', 'Initials': 'AJ', 'LastName': 'Allen', 'Affiliation': 'National Institute for Health Research Newcastle In Vitro Diagnostics Cooperative, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Phair', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Bowett', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Simpson', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK; National Institute for Health Research Newcastle In Vitro Diagnostics Cooperative, Newcastle University, Newcastle, UK. Electronic address: j.simpson@ncl.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30367-4']
3116,31493105,A Pilot Study of Family-Based Exposure-Focused Treatment for Youth with Autism Spectrum Disorder and Anxiety.,"Anxiety is a common and impairing condition in youth with autism spectrum disorders (ASD). Evidence supports the use of cognitive behavioral therapy for treating anxiety in this population; however, available treatment protocols may be difficult to implement outside of research settings. The present study examined the efficacy of family-based exposure-focused treatment (FET) compared to a treatment as usual (TAU) control in 32 youth aged 6-17 years with ASD and co-occurring anxiety. Fourteen youth were randomized to FET, which included 12 face-to-face weekly therapy sessions lasing 45-55 min, while 18 youth completed the TAU control where engagement in psychotherapy or pharmacotherapy was at the discretion of the families. Results strongly supported FET with a 79% (versus 0% in TAU) response rate, 86% (versus 0% in TAU) remission in primary anxiety diagnosis, and large between-group effects on clinician-rated anxiety severity and most parent-rated domains of anxiety-related impairment. Among treatment responders, 2-month follow-up supported maintenance of gains. Overall, the study supported FET as a relatively brief intervention for the treatment of anxiety in youth with ASD, although further research is needed to replicate these findings and compare FET outcomes to more comprehensive interventions.",2020,The present study examined the efficacy of family-based exposure-focused treatment (FET) compared to a treatment as usual (TAU) control in 32 youth aged 6-17 years with ASD and co-occurring anxiety.,"['Fourteen youth', '32 youth aged 6-17\xa0years with ASD and co-occurring anxiety', 'Youth with Autism Spectrum Disorder and Anxiety', 'youth with ASD', 'youth with autism spectrum disorders (ASD']","['FET', 'cognitive behavioral therapy', 'Family-Based Exposure-Focused Treatment', 'TAU control where engagement in psychotherapy or pharmacotherapy', 'family-based exposure-focused treatment (FET']",['clinician-rated anxiety severity'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",14.0,0.0297294,The present study examined the efficacy of family-based exposure-focused treatment (FET) compared to a treatment as usual (TAU) control in 32 youth aged 6-17 years with ASD and co-occurring anxiety.,"[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza MS:350, Houston, TX, 77030, USA. eric.storch@bcm.edu.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Schneider', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza MS:350, Houston, TX, 77030, USA.'}, {'ForeName': 'Alessandro S', 'Initials': 'AS', 'LastName': 'De Nadai', 'Affiliation': 'Psychology Department, Texas State University, San Marcos, TX, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Selles', 'Affiliation': ""University of British Columbia and BC Children's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'McBride', 'Affiliation': 'Department of Family and Preventive Medicine, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Grebe', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza MS:350, Houston, TX, 77030, USA.'}, {'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Bergez', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza MS:350, Houston, TX, 77030, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza MS:350, Houston, TX, 77030, USA.'}, {'ForeName': 'Andres G', 'Initials': 'AG', 'LastName': 'Viana', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Lewin', 'Affiliation': 'Department of Pediatrics, Rothman Center for Neuropsychiatry, University of South Florida, Saint Petersburg, FL, USA.'}]",Child psychiatry and human development,['10.1007/s10578-019-00923-3']
3117,32142371,The PCORnet Blood Pressure Control Laboratory: A Platform for Surveillance and Efficient Trials.,"BACKGROUND


Uncontrolled blood pressure (BP) is a leading preventable cause of death that remains common in the US population despite the availability of effective medications. New technology and program innovation has high potential to improve BP but may be expensive and burdensome for patients, clinicians, health systems, and payers and may not produce desired results or reduce existing disparities in BP control.
METHODS AND RESULTS


The PCORnet Blood Pressure Control Laboratory is a platform designed to enable national surveillance and facilitate quality improvement and comparative effectiveness research. The platform uses PCORnet, the National Patient-Centered Clinical Research Network, for engagement of health systems and collection of electronic health record data, and the Eureka Research Platform for eConsent and collection of patient-reported outcomes and mHealth data from wearable devices and smartphones. Three demonstration projects are underway: BP track will conduct national surveillance of BP control and related clinical processes by measuring theory-derived pragmatic BP control metrics using electronic health record data, with a focus on tracking disparities over time; BP MAP will conduct a cluster-randomized trial comparing effectiveness of 2 versions of a BP control quality improvement program; BP Home will conduct an individual patient-level randomized trial comparing effectiveness of smartphone-linked versus standard home BP monitoring. Thus far, BP Track has collected electronic health record data from over 826 000 eligible patients with hypertension who completed ≈3.1 million ambulatory visits. Preliminary results demonstrate substantial room for improvement in BP control (<140/90 mm Hg), which was 58% overall, and in the clinical processes relevant for BP control. For example, only 12% of patients with hypertension with a high BP measurement during an ambulatory visit received an order for a new antihypertensive medication.
CONCLUSIONS


The PCORnet Blood Pressure Control Laboratory is designed to be a reusable platform for efficient surveillance and comparative effectiveness research; results from demonstration projects are forthcoming.",2020,"Preliminary results demonstrate substantial room for improvement in BP control (<140/90 mm Hg), which was 58% overall, and in the clinical processes relevant for BP control.",['826 000 eligible patients with hypertension who completed ≈3.1 million ambulatory visits'],['smartphone-linked versus standard home BP monitoring'],['BP control'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",826000.0,0.0561908,"Preliminary results demonstrate substantial room for improvement in BP control (<140/90 mm Hg), which was 58% overall, and in the clinical processes relevant for BP control.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'Department of Epidemiology and Biostatistics (M.J.P., M.F.), University of California, San Francisco.'}, {'ForeName': 'Valy', 'Initials': 'V', 'LastName': 'Fontil', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine (M.J.P., V.F.), University of California, San Francisco.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carton', 'Affiliation': 'Division of Health Services Research, Louisiana Public Health Institute, Tulane University, New Orleans, LA. (T.C.).'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Shaw', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL (K.M.S., M.S.).'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL (K.M.S., M.S.).'}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Duke Clinical Research Institute, and Department of Population Health Sciences, Duke University School of Medicine, Durham, NC (S.C., E.C.O.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Todd', 'Affiliation': 'OCHIN, Portland, OR (J.T.).'}, {'ForeName': 'Alanna M', 'Initials': 'AM', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN (A.M.C.).'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, and Department of Population Health Sciences, Duke University School of Medicine, Durham, NC (S.C., E.C.O.).'}, {'ForeName': 'Madelaine', 'Initials': 'M', 'LastName': 'Faulkner', 'Affiliation': 'Department of Epidemiology and Biostatistics (M.J.P., M.F.), University of California, San Francisco.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Maeztu', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wozniak', 'Affiliation': 'Improving Health Outcomes, American Medical Association, Chicago, IL (G.W., M.R.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rakotz', 'Affiliation': 'Improving Health Outcomes, American Medical Association, Chicago, IL (G.W., M.R.).'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Shay', 'Affiliation': 'Center for Health Metrics and Evaluation, American Heart Association (C.M.S.).'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, University of Florida, College of Pharmacy, Gainesville, FL (R.M.C.D.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006115']
3118,32142572,Tomographic Assessment on the Influence of the Use of a Collagen Membrane on Dimensional Variations to Protect the Antrostomy After Maxillary Sinus Floor Augmentation: A Randomized Clinical Trial.,"PURPOSE


To evaluate the dimensional variations after elevation of the maxillary sinus floor and the healing of the antrostomy left unprotected or protected by a collagen membrane.
MATERIALS AND METHODS


Twenty patients were included in the study. After the elevation of the sinus mucosa, natural bovine bone was grafted into the elevated space. In 10 randomly selected patients, a native collagen membrane made of porcine corium was placed on the antrostomy (membrane group). In the other 10 patients, the antrostomy was left uncovered (no-membrane group). Cone beam computed tomography (CBCT) images were taken for all patients before surgery (T0), 1 week after sinus floor augmentation (T1), and after 9 months of healing (T2), and evaluations of dimensional variations over time of soft and hard tissues were performed.
RESULTS


At T1, the elevation of the sinus floor in the middle aspect was 12.5 ± 3.8 mm and 11.9 ± 3.6 mm in the membrane and no-membrane groups, respectively. At T2, the reduction in height of the elevated space was 0.6 ± 0.9 mm and 0.8 ± 0.8 mm in the membrane and no-membrane groups, respectively. The elevated area decreased between ~10% and 11% in the membrane group and between ~15% to 20% in the no-membrane group. However, no statistically significant differences were found.
CONCLUSION


The use of a collagen membrane to cover the antrostomy after sinus floor elevation did not produce significant clinical effects on dimensional variations over time.",2020,The use of a collagen membrane to cover the antrostomy after sinus floor elevation did not produce significant clinical effects on dimensional variations over time.,"['10 randomly selected patients, a native collagen membrane made of porcine corium was placed on the antrostomy (membrane group', 'Twenty patients were included in the study', 'After Maxillary Sinus Floor Augmentation']","['Cone beam computed tomography (CBCT', 'Collagen Membrane']","['elevation of the sinus floor', 'elevated area', 'height of the elevated space']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0011646', 'cui_str': 'Corium'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3178819', 'cui_str': 'Maxillary Sinus Floor Augmentation'}]","[{'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",20.0,0.030188,The use of a collagen membrane to cover the antrostomy after sinus floor elevation did not produce significant clinical effects on dimensional variations over time.,"[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': ''}, {'ForeName': 'Niklaus Peter', 'Initials': 'NP', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Ferri', 'Affiliation': ''}, {'ForeName': 'Atsuya', 'Initials': 'A', 'LastName': 'Hirota', 'Affiliation': ''}, {'ForeName': 'Karol Al', 'Initials': 'KA', 'LastName': 'Apaza Alccayhuaman', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Botticelli', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7843']
3119,32202155,A  Promotor -Led Pilot Study to Increase Colorectal Cancer Screening in Latinos: The  Juntos Contra El Cáncer  Program.,"Background.  Latinos have lower colorectal cancer (CRC) screening rates compared to other racial/ethnic groups in the United States, despite an overall increase in CRC screening over the past 10 years. To address this disparity, we implemented a  promotor -led intervention to increase CRC screening test adherence in community-based settings, connecting community members with a partnering federally qualified health center.  Purpose . To evaluate the  Juntos Contra el Cáncer /Together Against Cancer (JUNTOS) intervention, by assessing pre-post changes in (1) CRC screening test adherence and (2) CRC knowledge and perceived barriers to CRC screening. We also assessed the feasibility and acceptability of program activities.  Method . JUNTOS was a group-based intervention, delivered by promotores (community health workers), to promote CRC screening test adherence among Latino adults. The intervention consisted of a culturally tailored 2½-hour interactive workshop followed by an appointment scheduling assistance from a promotor. Workshop participants were Latino adults (males and females) aged 50 to 75 years who were not up-to-date with CRC screening guidelines. We conducted interviews before and 6 to 9 months after the workshop to assess program outcomes.  Results . Of the 177 participants included, 118 reported completing the CRC screening test (66.7%) by 6 to 9 months postintervention. We observed baseline to 6- to 9-month increase in CRC knowledge and lower perceived barriers to obtaining CRC screening. Furthermore, the intervention was found to be feasible and acceptable.  Conclusion . Results suggest that JUNTOS can be feasibly implemented in partnership with a federally qualified health center. The current study supports group-based CRC interventions in community and clinic settings.",2020,"Of the 177 participants included, 118 reported completing the CRC screening test (66.7%) by 6 to 9 months postintervention.","['community-based settings, connecting community members with a partnering federally qualified health center', 'among Latino adults', 'Latinos', '177 participants included, 118 reported completing the CRC screening test (66.7%) by 6 to 9 months postintervention', 'Workshop participants were Latino adults (males and females) aged 50 to 75 years who were not up-to-date with CRC screening guidelines']","['CRC screening test adherence', 'culturally tailored 2½-hour interactive workshop followed by an appointment scheduling assistance from a promotor']","['CRC screening', 'CRC knowledge', 'colorectal cancer (CRC) screening rates']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]",177.0,0.0135493,"Of the 177 participants included, 118 reported completing the CRC screening test (66.7%) by 6 to 9 months postintervention.","[{'ForeName': 'Elva M', 'Initials': 'EM', 'LastName': 'Arredondo', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Dumbauld', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Milla', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Madanat', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Haughton', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Garcia-Bigley', 'Affiliation': 'Family Health Centers of San Diego, San Diego, CA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ramers', 'Affiliation': 'Family Health Centers of San Diego, San Diego, CA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Nodora', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Balambal', 'Initials': 'B', 'LastName': 'Bharti', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lopez', 'Affiliation': 'Family Health Centers of San Diego, San Diego, CA, USA.'}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Diaz', 'Affiliation': 'Family Health Centers of San Diego, San Diego, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Marquez', 'Affiliation': 'Family Health Centers of San Diego, San Diego, CA, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}]",Health promotion practice,['10.1177/1524839920912240']
3120,32108888,Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial.,"Importance


Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated.
Objective


To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE.
Design, Setting, and Participants


This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted.
Intervention


Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations.
Main Outcomes and Measures


The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs.
Results


A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49).
Conclusions and Relevance


An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events.
Trial Registration


ClinicalTrials.gov Identifier: NCT02684721.",2020,"Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17","['140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up', 'patients with acute PE.\nDesign, Setting, and Participants', '4 regional hospitals and 1 university hospital in Denmark', '140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years', 'Patients With Acute Pulmonary Embolism']","['rehabilitation intervention', 'brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations', 'Physiotherapist-Guided Home-Based Exercise Intervention', 'control intervention']","['Pulmonary Embolism Quality of Life', 'sick leave', 'Pulmonary Embolism Quality of Life questionnaire', 'Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs', 'Physical Capacity and Patient-Reported Outcomes', 'EuroQol-5 Dimensions-3 Levels questionnaire']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0034380'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0033978', 'cui_str': 'Psychoactive Drugs'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",140.0,0.125402,"Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jannie R', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Torben B', 'Initials': 'TB', 'LastName': 'Larsen', 'Affiliation': 'Thrombosis and Drug Research Unit, Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Jensen', 'Affiliation': 'Department of Physical and Occupational Therapy, Regional Hospital Herning, Herning, Denmark.'}, {'ForeName': 'Hanne R', 'Initials': 'HR', 'LastName': 'Mikkelsen', 'Affiliation': 'Diagnostic Center, Department of Cardiology, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frost', 'Affiliation': 'Diagnostic Center, Department of Cardiology, Silkeborg Regional Hospital, Silkeborg, Denmark.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0064']
3121,32142566,Albumin-Impregnated Allograft Filling of Surgical Extraction Sockets Achieves Better Bone Remodeling Than Filling with Either Blood Clot or Bovine Xenograft.,"PURPOSE


The goal of this study was to compare bone graft materials in mandibular third molar extraction sockets and to monitor bone remodeling and complications.
MATERIALS AND METHODS


Patients with bilateral, impacted mandibular third molars were involved. Twenty-four patients were planned to be randomly assigned to three possible treatments: (1) the control sockets were left empty; (2) the socket was filled with bovine xenograft (Bio-Oss); or (3) the socket was filled with albumin-impregnated bone allograft (BoneAlbumin). Postoperative pain during the first week was determined with the visual analog scale. Cone beam computed tomography (CBCT) images were taken at 6 and 12 weeks and 1 year postoperatively for micromorphologic analysis and measurement of pocket depth at the second molar. Patients and image analyses were blinded toward the treatment group (randomized double-blind split-mouth design).
RESULTS


Postoperative pain was lowest in the allograft group (control: 5.06 ± 0.53; xenograft: 5.85 ± 0.42; allograft: 3.94 ± 0.52; P < .05). At weeks 6 and 12, early signs of remodeling were observed in the allograft group and the controls, while bone xenograft was still demarcated from the host bone. The 1-year CBCT images showed complete remodeling and integration of allograft with natural trabecular structure, while the xenograft particles were still visible. Support for the second molar was significantly better, as evidenced by less deep and prevalent pockets in the allograft-filled group compared with the controls (P = .017).
CONCLUSION


Filling an extraction socket with albumin-integrated allografts provides superior bone regeneration compared to either native bone buildup or xenograft application or socket regeneration without bone grafting.",2020,"Support for the second molar was significantly better, as evidenced by less deep and prevalent pockets in the allograft-filled group compared with the controls (P = .017).
","['Patients with bilateral, impacted mandibular third molars were involved']","['Cone beam computed tomography (CBCT', 'Blood Clot or Bovine Xenograft', 'Albumin-Impregnated Allograft Filling of Surgical Extraction Sockets', 'control sockets were left empty; (2) the socket was filled with bovine xenograft (Bio-Oss); or (3) the socket was filled with albumin-impregnated bone allograft (BoneAlbumin']","['early signs of remodeling', 'bone xenograft', 'Postoperative pain', 'visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0522537', 'cui_str': 'Xenografts'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0174021', 'cui_str': 'BioOss'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0522537', 'cui_str': 'Xenografts'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",24.0,0.0754992,"Support for the second molar was significantly better, as evidenced by less deep and prevalent pockets in the allograft-filled group compared with the controls (P = .017).
","[{'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Simonffy', 'Affiliation': ''}, {'ForeName': 'Fanni', 'Initials': 'F', 'LastName': 'Minya', 'Affiliation': ''}, {'ForeName': 'Balint', 'Initials': 'B', 'LastName': 'Trimmel', 'Affiliation': ''}, {'ForeName': 'Zsombor', 'Initials': 'Z', 'LastName': 'Lacza', 'Affiliation': ''}, {'ForeName': 'Csaba', 'Initials': 'C', 'LastName': 'Dobo-Nagy', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7554']
3122,31999341,Conventional versus ultrasound treat to target: no difference in magnetic resonance imaging inflammation or joint damage over 2 years in early rheumatoid arthritis.,"OBJECTIVE


To investigate whether an ultrasound-guided treat-to-target strategy for early RA would lead to reduced MRI inflammation or less structural damage progression compared with a conventional treat-to-target strategy.
METHODS


A total of 230 DMARD-naïve early RA patients were randomized to an ultrasound tight control strategy targeting DAS <1.6, no swollen joints and no power Doppler signal in any joint or a conventional strategy targeting DAS <1.6 and no swollen joints. Patients in both arms were treated according to the same DMARD escalation strategy. MRI of the dominant hand was performed at six time points over 2 years and scored according to the OMERACT RA MRI scoring system. A total of 218 patients had baseline and one or more follow-up MRIs and were included in the analysis. The mean MRI score change from baseline to each follow-up and the 2 year risk for erosive progression were compared between arms.
RESULTS


MRI bone marrow oedema, synovitis and tenosynovitis improved over the first year and was sustained during the second year of follow-up, with no statistically significant differences between the ultrasound and the conventional arms at any time point. The 2 year risk for progression of MRI erosions was similar in both treatment arms: ultrasound arm 39%, conventional arm 33% [relative risk 1.16 (95% CI 0.81, 1.66), P = 0.40].
CONCLUSION


Incorporating ultrasound information in treatment decisions did not lead to reduced MRI inflammation or less structural damage compared with a conventional treatment strategy. The findings support that systematic use of ultrasound does not provide a benefit in the follow-up of patients with early RA.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov, http://clinicaltrials.gov, NCT01205854.",2020,Incorporating ultrasound information in treatment decisions did not lead to reduced MRI inflammation or less structural damage compared with a conventional treatment strategy.,"['early rheumatoid arthritis', 'A total of 230 DMARD-naïve early RA patients', '218 patients had baseline and one or more follow-up MRIs and were included in the analysis']","['ultrasound tight control strategy targeting DAS <1.6, no swollen joints and no power Doppler signal in any joint or a conventional strategy targeting DAS <1.6 and no swollen joints', 'Conventional versus ultrasound treat']","['MRI inflammation', 'MRI bone marrow oedema, synovitis and tenosynovitis', 'mean MRI score change', 'progression of MRI erosions']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0948162', 'cui_str': 'Edema of bone marrow'}, {'cui': 'C0039104', 'cui_str': 'Synovitis and tenosynovitis (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}]",230.0,0.171034,Incorporating ultrasound information in treatment decisions did not lead to reduced MRI inflammation or less structural damage compared with a conventional treatment strategy.,"[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Sundin', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Anna-Birgitte', 'Initials': 'AB', 'LastName': 'Aga', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Skare', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Lena B', 'Initials': 'LB', 'LastName': 'Nordberg', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Uhlig', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Hilde B', 'Initials': 'HB', 'LastName': 'Hammer', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Tore K', 'Initials': 'TK', 'LastName': 'Kvien', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Lillegraven', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Espen A', 'Initials': 'EA', 'LastName': 'Haavardsholm', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez674']
3123,31621606,How to evaluate effects of occupational therapy - lessons learned from an exploratory randomized controlled trial.,"BACKGROUND


Although occupational therapy (OT) is frequently prescribed in clinical practice, there is still insufficient evidence regarding its efficacy to improve Parkinson's Disease (PD)-related activity limitations.
OBJECTIVES


To evaluate the efficacy of OT and the validity of different outcome-parameters to reflect efficacy, including gold-standard clinical rating scales and quantitative motor assessments.
METHODS


40 patients were included in an exploratory, randomized-controlled, single-blinded trial, receiving either (I) ten weeks of OT, with a main focus on motor aspects of activity limitations and a ten-week follow-up assessment or (II) no intervention. Inclusion criteria were diagnosis of PD and Hoehn & Yahr stage 2-3. Patients with major depression, other neurological or orthopedic diseases or OT beforehand were excluded from the study. To monitor treatment effects the MDS-UPDRS part II and III were used for patient- and clinician-based assessment. Objective Pegboard as well as Q-Motor ""tremormotography"" and ""digitomotography"" were applied.
RESULTS


The interventional group reported a subjective amelioration of activity limitations, with a significant improvement of MDS-UPDRS part II at the end of the study (p = 0.030). However, clinician's rating and quantitative motor assessment failed to detect a significant improvement of motor impairment and fine motor control.
CONCLUSIONS


This study goes in line with previous trials, showing an individual improvement of activity limitations from the patients' point of view. The discrepancy between self-perception, focusing on activity limitation, and clinician-based rating, focusing on motor impairment, challenges the current gold standard assessments as valid outcome parameters for occupational therapy trials aiming for an individualized improvement of disease burden.",2019,"However, clinician's rating and quantitative motor assessment failed to detect a significant improvement of motor impairment and fine motor control.
","['Patients with major depression, other neurological or orthopedic diseases or OT beforehand were excluded from the study', '40 patients']","['OT', 'occupational therapy (OT', 'occupational therapy - lessons', 'OT, with a main focus on motor aspects of activity limitations and a ten-week follow-up assessment or (II) no intervention']","['motor impairment and fine motor control', 'MDS-UPDRS part II', 'subjective amelioration of activity limitations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]",40.0,0.0426542,"However, clinician's rating and quantitative motor assessment failed to detect a significant improvement of motor impairment and fine motor control.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Neurology, Christian-Albrecht-University Kiel, Kiel, Germany. Electronic address: eva.schaeffer@uksh.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Streich', 'Affiliation': 'Department of Neurodegeneration, Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wurster', 'Affiliation': 'Department of Neurodegeneration, Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schubert', 'Affiliation': 'George Huntington Institute, Münster, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reilmann', 'Affiliation': 'Department of Neurodegeneration, Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany; George Huntington Institute, Münster, Germany; Department of Clinical Radiology, University of Münster, Münster, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wolfram', 'Affiliation': 'Center for Outpatient Rehabilitation (ZAR), Tuebingen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Department of Neurology, Christian-Albrecht-University Kiel, Kiel, Germany; Department of Neurodegeneration, Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.09.013']
3124,32179844,Use of mouse-tracking software to detect faking-good behavior on personality questionnaires: an explorative study.,"The aim of the present study was to explore whether kinematic indicators could improve the detection of subjects demonstrating faking-good behaviour when responding to personality questionnaires. One hundred and twenty volunteers were randomly assigned to one of four experimental groups (honest unspeeded, faking-good unspeeded, honest speeded, and faking-good speeded). Participants were asked to respond to the MMPI-2 underreporting scales (L, K, S) and the PPI-R Virtuous Responding (VR) scale using a computer mouse. The collected data included T-point scores on the L, K, S, and VR scales; response times on these scales; and several temporal and spatial mouse parameters. These data were used to investigate the presence of significant differences between the two manipulated variables (honest vs. faking-good; speeded vs. unspeeded). The results demonstrated that T-scores were significantly higher in the faking-good condition relative to the honest condition; however, faking-good and honest respondents showed no statistically significant differences between the speeded and unspeeded conditions. Concerning temporal and spatial kinematic parameters, we observed mixed results for different scales and further investigations are required. The most consistent finding, albeit with small observed effects, regards the L scale, in which faking-good respondents took longer to respond to stimuli and outlined wider mouse trajectories to arrive at the given response.",2020,"The results demonstrated that T-scores were significantly higher in the faking-good condition relative to the honest condition; however, faking-good and honest respondents showed no statistically significant differences between the speeded and unspeeded conditions.",['One hundred and twenty volunteers'],"['faking-good unspeeded, honest speeded, and faking-good speeded', 'mouse-tracking software']","['MMPI-2 underreporting scales (L, K, S) and the PPI-R Virtuous Responding (VR) scale', 'personality questionnaires', 'T-point scores on the L, K, S, and VR scales; response times on these scales; and several temporal and spatial mouse parameters', 'T-scores']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}]","[{'cui': 'C0026320', 'cui_str': 'Minnesota Multiphasic Personality Inventory'}, {'cui': 'C0222045'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3854607', 'cui_str': 'T score'}]",120.0,0.012704,"The results demonstrated that T-scores were significantly higher in the faking-good condition relative to the honest condition; however, faking-good and honest respondents showed no statistically significant differences between the speeded and unspeeded conditions.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Merylin', 'Initials': 'M', 'LastName': 'Monaro', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Burla', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colasanti', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Orrù', 'Affiliation': 'Department of Surgical, Medical, Molecular & Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferracuti', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Roma', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy. paolo.roma@uniroma1.it.'}]",Scientific reports,['10.1038/s41598-020-61636-5']
3125,29196938,The hemodynamic and pain impact of peripheral nerve block versus spinal anesthesia in diabetic patients undergoing diabetic foot surgery.,"PURPOSE


Comparison of hemodynamic profiles and pain scores in diabetic patients undergoing diabetic foot surgery receiving peripheral nerve block (PNB) or spinal anesthesia [subarachnoid block (SAB)].
METHODS


This was a prospective, randomised controlled trial. We recruited diabetic patients aged > 18 years, American Society of Anesthesiologists class II-III, who were scheduled for unilateral diabetic foot surgery below the knee. All patients were assessed for autonomic dysfunction using the Survey of Autonomic Symptoms score. Participants were randomly assigned to receive either PNB or SAB for the surgery. Hemodynamic data, including usage of vasopressors, were recorded at 5-min intervals for up to 1 h after the induction of anesthesia. Pain scores were recorded postoperatively, and follow-up was done via telephone 6 months later.
RESULTS


Compared to the PNB group, the SAB group had a larger number of patients with significant hypotension (14 vs. 1; p = 0.001) and more patients who required vasopressor boluses (6 vs. 0 patients). Compared to SAB group, the patients in the PNB group had a longer postoperative pain-free duration (9 vs. 4.54 h; p = 0.002) and lower pain scores 1 day after surgery (3.63 vs. 4.69; p = 0.01).
CONCLUSION


Peripheral nerve block should be considered, whenever possible, as the first option of anesthesia for lower limb surgery in diabetic patients as it provides hemodynamic stability and superior postoperative pain control compared to SAB.
TRIAL REGISTRATION


Clinical trial registry: ClinicalTrials.gov. ID NCT02727348.",2020,"Compared to the PNB group, the SAB group had a larger number of patients with significant hypotension (14 vs. 1; p = 0.001) and more patients who required vasopressor boluses (6 vs. 0 patients).","['diabetic patients undergoing diabetic foot surgery', 'diabetic patients', 'diabetic patients undergoing diabetic foot surgery receiving peripheral nerve block (PNB) or spinal anesthesia [subarachnoid block (SAB', 'diabetic patients aged\xa0>\xa018\xa0years, American Society of Anesthesiologists class II-III, who were scheduled for unilateral diabetic foot surgery below the knee']","['PNB', 'SAB', 'PNB or SAB', 'peripheral nerve block versus spinal anesthesia']","['lower pain scores', 'hypotension', 'Pain scores', 'pain scores', 'postoperative pain-free duration', 'autonomic dysfunction']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}]",,0.0810927,"Compared to the PNB group, the SAB group had a larger number of patients with significant hypotension (14 vs. 1; p = 0.001) and more patients who required vasopressor boluses (6 vs. 0 patients).","[{'ForeName': 'Hou Yee', 'Initials': 'HY', 'LastName': 'Lai', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Li Lian', 'Initials': 'LL', 'LastName': 'Foo', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siu Min', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chen Fei', 'Initials': 'CF', 'LastName': 'Yong', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Pui San', 'Initials': 'PS', 'LastName': 'Loh', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Sook Hui', 'Initials': 'SH', 'LastName': 'Chaw', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia. sh_chaw@yahoo.com.'}, {'ForeName': 'Mohd Shahnaz', 'Initials': 'MS', 'LastName': 'Hasan', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chew Yin', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}]",Clinical autonomic research : official journal of the Clinical Autonomic Research Society,['10.1007/s10286-017-0485-8']
3126,32133525,Blood pressure in frail older adults: associations with cardiovascular outcomes and all-cause mortality.,"BACKGROUND


Blood pressure (BP) management in frail older people is challenging. An randomised controlled trial of largely non-frail older people found cardiovascular and mortality benefit with systolic (S) BP target <120 mmHg. However, all-cause mortality by attained BP in routine care in frail adults aged above 75 is unclear.
OBJECTIVES


To estimate observational associations between baseline BP and mortality/cardiovascular outcomes in a primary-care population aged above 75, stratified by frailty.
METHODS


Prospective observational analysis using electronic health records (clinical practice research datalink, n = 415,980). We tested BP associations with cardiovascular events and mortality using competing and Cox proportional-hazards models respectively (follow-up ≤10 years), stratified by baseline electronic frailty index (eFI: fit (non-frail), mild, moderate, severe frailty), with sensitivity analyses on co-morbidity, cardiovascular risk and BP trajectory.
RESULTS


Risks of cardiovascular outcomes increased with SBPs >150 mmHg. Associations with mortality varied between non-frail <85 and frail 75-84-year-olds and all above 85 years. SBPs above the 130-139-mmHg reference were associated with lower mortality risk, particularly in moderate to severe frailty or above 85 years (e.g. 75-84 years: 150-159 mmHg Hazard Ratio (HR) mortality compared to 130-139: non-frail HR = 0.94, 0.92-0.97; moderate/severe frailty HR = 0.84, 0.77-0.92). SBP <130 mmHg and Diastolic(D)BP <80 mmHg were consistently associated with excess mortality, independent of BP trajectory toward the end of life.
CONCLUSIONS


In representative primary-care patients aged ≥75, BP <130/80 was associated with excess mortality. Hypertension was not associated with increased mortality at ages above 85 or at ages 75-84 with moderate/severe frailty, perhaps due to complexities of co-existing morbidities. The priority given to aggressive BP reduction in frail older people requires further evaluation.",2020,"Hypertension was not associated with increased mortality at ages above 85 or at ages 75-84 with moderate/severe frailty, perhaps due to complexities of co-existing morbidities.","['frail older adults', 'a primary-care population aged above 75, stratified by frailty', 'frail older people', 'Prospective observational analysis using electronic health records (clinical practice research datalink, n\xa0=\u2009415,980', 'representative primary-care patients aged ≥75, BP <130/80 was associated with excess mortality', 'frail adults aged above 75', 'largely non-frail older people found cardiovascular and mortality benefit with systolic (S) BP target <120\xa0mmHg', 'non-frail <85 and frail 75-84-year-olds and all above 85 years']","['Diastolic(D)BP', 'Blood pressure (BP) management']","['baseline BP and mortality/cardiovascular outcomes', 'mortality', 'Blood pressure', 'mmHg Hazard Ratio (HR) mortality', 'co-morbidity, cardiovascular risk and BP trajectory']","[{'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0079320', 'cui_str': 'Mortality, Excess'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1272452', 'cui_str': 'Manage blood pressure taking'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0600773,"Hypertension was not associated with increased mortality at ages above 85 or at ages 75-84 with moderate/severe frailty, perhaps due to complexities of co-existing morbidities.","[{'ForeName': 'Jane A H', 'Initials': 'JAH', 'LastName': 'Masoli', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Pilling', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strain', 'Affiliation': 'Department of Healthcare for Older People, Royal Devon and Exeter Hospital, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Melzer', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}]",Age and ageing,['10.1093/ageing/afaa028']
3127,31521192,Sustained remission with methotrexate monotherapy after 22-week induction treatment with TNF-alpha inhibitor and methotrexate in early psoriatic arthritis: an open-label extension of a randomized placebo-controlled trial.,"BACKGROUND


If TNF inhibitors are initiated in the early stages of psoriatic arthritis, this could potentially modulate disease and therefore allow us to discontinue the TNF inhibitor after achieving remission.
OBJECTIVE


To investigate whether remission induced by tumour necrosis factor alpha inhibitor (TNFi) and methotrexate in patients with early psoriatic arthritis is sustained after withdrawal of TNFi.
METHODS


Open-label extension of a recently published double-blind, randomized placebo-controlled trial. Patients with psoriatic arthritis fulfilling the CASPAR criteria and with active disease at baseline (swollen and tender joint count ≥ 3) were randomized to either golimumab and methotrexate or matched placebo and methotrexate. Patients in Disease Activity Score (DAS) remission at week 22 continued in the open-label extension on methotrexate monotherapy. The primary end point was the percentage of patients in DAS-CRP remission (DAS < 1.6) at week 50.
RESULTS


Eight patients from the original placebo group and 18 patients from the original TNFi group continued in the extension phase. At week 50, 6 out of 8 (75%) patients from the original MTX (methotrexate) group versus 10 out of 18 (56%) patients from the original MTX+TNFi group were in DAS-CRP remission (p = 0.347). Considering the total study population, 6 out of 24 (25%) of the original MTX group versus 10 out of 26 (38.5%) of the original MTX+TNFi group were in DAS remission at week 50 (p = 0.308).
CONCLUSIONS


Remission achieved by initial combination treatment with TNFi and methotrexate in early psoriatic arthritis is maintained on methotrexate monotherapy in approximately half of the patients.
TRIAL REGISTRATION


Registered at Clinicaltrials.gov with number NCT01871649 on June 7, 2013.",2019,"The primary end point was the percentage of patients in DAS-CRP remission (DAS < 1.6) at week 50.
","['Patients with psoriatic arthritis fulfilling the CASPAR criteria and with active disease at baseline (swollen and tender joint count ≥\u20093', 'early psoriatic arthritis', 'patients with early psoriatic arthritis']","['tumour necrosis factor\xa0alpha inhibitor (TNFi) and methotrexate', 'golimumab and methotrexate or matched placebo and methotrexate', 'placebo', 'MTX (methotrexate', 'TNF-alpha inhibitor and methotrexate', 'methotrexate monotherapy', 'TNFi and methotrexate', 'original MTX']","['Disease Activity Score (DAS) remission', 'DAS remission', 'percentage of patients in DAS-CRP remission', 'DAS-CRP remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C4521709', 'cui_str': 'Tumor necrosis factor alpha inhibitor'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.281034,"The primary end point was the percentage of patients in DAS-CRP remission (DAS < 1.6) at week 50.
","[{'ForeName': 'Henriëtte M Y', 'Initials': 'HMY', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Leonieke J J', 'Initials': 'LJJ', 'LastName': 'van Mens', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Nurmohamed', 'Affiliation': 'Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam, the Netherlands.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Kok', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Arno W R', 'Initials': 'AWR', 'LastName': 'van Kuijk', 'Affiliation': 'Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam, the Netherlands.'}, {'ForeName': 'Dominique L P', 'Initials': 'DLP', 'LastName': 'Baeten', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen G H', 'Initials': 'MGH', 'LastName': 'van de Sande', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.g.vandesande@amc.uva.nl.'}]",Arthritis research & therapy,['10.1186/s13075-019-1998-4']
3128,31619350,An exploratory study of vibration therapy on muscle function in patients with peripheral artery disease.,"OBJECTIVE


The purpose of this exploratory study was to determine whether a single session of vibration therapy (VT) would improve muscular and functional performance in individuals with symptomatic peripheral artery disease (PAD).
METHODS


In a randomized, balanced cross-over design fourteen PAD participants with intermittent claudication (mean ± standard deviation; age, 73.9 ± 4.6 years; height, 172.6 ± 68.4 cm; body mass, 85.2 ± 15.7 kg) performed VT and control that involved repeated chair rises, timed up-and-go test, and 6-minute walk test. Each intervention was separated by at least 2 days. Wearable VT devices were positioned on the right and left lower limbs that were turned on during functional testing but were turned off for the control intervention.
RESULTS


VT significantly improved (P < .05) repeated chair rises and timed up-and-go test compared with control with a small effect size of 0.46 and 0.45, respectively. Similarly, a significant (P < .01) and meaningful change in 6-minute walk test was noted in VT compared with control.
CONCLUSIONS


This exploratory study suggest that VT may enhance functional strength, mobility, and walking performance by extending the onset of claudication and increasing walking distance in PAD with intermittent claudication. However, further study is required to confirm and extend these preliminary findings and determine the potential mechanisms of action in VT.",2020,"RESULTS


VT significantly improved (P < .05) repeated chair rises and timed up-and-go test compared with control with a small effect size of 0.46 and 0.45, respectively.","['fourteen PAD participants with intermittent claudication (mean\xa0± standard deviation; age, 73.9\xa0± 4.6\xa0years; height, 172.6\xa0± 68.4\xa0cm; body mass, 85.2\xa0± 15.7\xa0kg) performed', 'patients with peripheral artery disease', 'individuals with symptomatic peripheral artery disease (PAD']","['VT and control that involved repeated chair rises, timed up-and-go test, and 6-minute walk test', 'VT', 'vibration therapy (VT', 'vibration therapy']","['meaningful change in 6-minute walk test', 'muscular and functional performance', 'functional strength, mobility, and walking performance', 'muscle function']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",14.0,0.0657549,"RESULTS


VT significantly improved (P < .05) repeated chair rises and timed up-and-go test compared with control with a small effect size of 0.46 and 0.45, respectively.","[{'ForeName': 'Darryl J', 'Initials': 'DJ', 'LastName': 'Cochrane', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, New Zealand. Electronic address: d.cochrane@massey.ac.nz.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cochrane', 'Affiliation': 'Department of Vascular, Endovascular and Transplant Surgery, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Roake', 'Affiliation': 'Department of Vascular, Endovascular and Transplant Surgery, Christchurch Hospital, Christchurch, New Zealand; Department of Surgery, University of Otago, Christchurch, New Zealand.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.06.214']
3129,32108889,Effect of Adding a Work-Focused Intervention to Integrated Care for Depression in the Veterans Health Administration: A Randomized Clinical Trial.,"Importance


Thousands of working-age veterans with depression experience impaired occupational functioning.
Objectives


To test whether the Veterans Health Administration (VHA) integrated care (IC) program combined with telephonic work-focused counseling, known as Be Well at Work (BWAW), is superior to IC alone for improving occupational functioning and depression, to determine whether these effects persist 4 months later, and to determine whether the return on investment is positive.
Design, Setting, and Participants


In this randomized clinical trial conducted from October 21, 2014, to December 6, 2019, patients undergoing IC at VHA facilities were screened for eligibility and randomized to IC alone or IC plus BWAW. Blinded interviewers administered questionnaires before the intervention, immediately after completion of the intervention at month 4, and at month 8. Eligibility criteria were individuals 18 years or older who were working at least 15 hours per week in a job they had occupied for at least 6 months, were experiencing work limitations, and had current major depressive disorder or persistent depressive disorder. Exclusion criteria were individuals who could not read or speak English, had planned maternity leave, or had a history of bipolar disorder or psychosis. Data analyses were conducted from January 1, 2018, to December 6, 2019.
Interventions


Integrated care is multidisciplinary depression care involving screening, clinical informatics, measurement-based care, brief behavioral interventions, and referral as needed to specialty mental health care. Be Well at Work counseling involves 8 biweekly telephone sessions and 1 telephone booster visit after 4 months. Doctoral-level psychologists helped patients to identify barriers to functioning and to adopt new work-focused cognitive-behavioral and work-modification strategies.
Main Outcomes and Measures


The primary outcome was the adjusted mean group difference in changes from before to after intervention (hereafter, adjusted effect) in the percentage of at-work productivity loss, measured with the Work Limitations Questionnaire (range, 0%-25%). The secondary outcome was adjusted effect in the Patient Health Questionnaire 9-item symptom severity score (range, 0-27, with 0 indicating no symptoms and 27, severe symptoms).
Results


Of 670 veterans referred for participation, 287 veterans (42.8%) consented and completed eligibility screening, and 253 veterans (37.8%) were randomized. Among these 253 patients (mean [SD] age, 45.7 [11.6] years; 218 [86.2%] men; 135 [53.4%] white), 114 (45.1%) were randomized to IC and 139 (54.9%) were randomized to IC plus BWAW. At the 4-month follow-up, patients who received IC plus BWAW had greater reductions in at-work productivity loss (adjusted effect, -1.7; 95% CI, -3.1 to -0.4; P = .01) and depression symptom severity (adjusted effect, -2.1; 95% CI, -3.5 to -0.7; P = .003). The improvements from IC plus BWAW persisted 4 months after intervention (at-work productivity loss mean difference, -0.5; 95% CI, -1.9 to 0.9; P = .46; depression symptom severity mean difference, 0.6; 95% CI -0.9 to 2.1; P = .44). The cost per patient participating in BWAW was $690.98, and the return on investment was 160%.
Conclusions and Relevance


These findings suggest that adding this work-focused intervention to IC improves veterans' occupational and psychiatric outcomes, reducing obstacles to having a productive civilian life.
Trial Registration


ClinicalTrials.gov Identifier: NCT02111811.",2020,"At the 4-month follow-up, patients who received IC plus BWAW had greater reductions in at-work productivity loss (adjusted effect, -1.7; 95% CI, -3.1 to -0.4; P = .01) and depression symptom severity (adjusted effect, -2.1; 95% CI, -3.5 to -0.7; P = .003).","['253 patients (mean [SD] age, 45.7 [11.6] years; 218 [86.2%] men; 135 [53.4%] white), 114 (45.1%) were randomized to IC and 139 (54.9', '670 veterans referred for participation, 287 veterans (42.8%) consented and completed eligibility screening, and 253 veterans (37.8%) were randomized', 'Exclusion criteria were individuals who could not read or speak English, had planned maternity leave, or had a history of bipolar disorder or psychosis', 'working-age veterans with depression experience impaired occupational functioning', 'Eligibility criteria were individuals 18 years or older who were working at least 15 hours per week in a job they had occupied for at least 6 months, were experiencing work limitations, and had current major depressive disorder or persistent depressive disorder', 'from October 21, 2014, to December 6, 2019, patients undergoing IC at VHA facilities']","['IC alone or IC plus BWAW', 'Work-Focused Intervention to Integrated Care', 'Veterans Health Administration (VHA) integrated care (IC) program combined with telephonic work-focused counseling, known as Be Well at Work (BWAW']","['work productivity loss', 'Patient Health Questionnaire 9-item symptom severity score (range, 0-27, with 0 indicating no symptoms and 27, severe symptoms', 'percentage of at-work productivity loss, measured with the Work Limitations Questionnaire', 'depression symptom severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0332315', 'cui_str': 'Has plan (attribute)'}, {'cui': 'C0557441', 'cui_str': 'On maternity leave (finding)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4087263', 'cui_str': 'Persistent depressive disorder'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.177996,"At the 4-month follow-up, patients who received IC plus BWAW had greater reductions in at-work productivity loss (adjusted effect, -1.7; 95% CI, -3.1 to -0.4; P = .01) and depression symptom severity (adjusted effect, -2.1; 95% CI, -3.5 to -0.7; P = .003).","[{'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Lerner', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, and Tufts University School of Medicine and Tufts Graduate School of Biomedical Sciences, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Adler', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, and Tufts University School of Medicine and Tufts Graduate School of Biomedical Sciences, Boston, Massachusetts.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Rogers', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, and Tufts University School of Medicine and Tufts Graduate School of Biomedical Sciences, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ingram', 'Affiliation': 'Veterans Integrated Service Network 4 Mental Illness Research, Education, and Clinical Center, Center of Excellence, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Oslin', 'Affiliation': 'Veterans Integrated Service Network 4 Mental Illness Research, Education, and Clinical Center, Center of Excellence, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0075']
3130,31922462,Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease.,"PURPOSE


We assessed the long-term safety and immunogenicity profile of collagenase clostridium histolyticum and characterized penile curvature deformity over time in patients previously treated for Peyronie's disease.
MATERIALS AND METHODS


This phase 4 study included men who received collagenase clostridium histolyticum in either 12-month, double-blind, placebo controlled clinical trials (IMPRESS I/II), or one of two 9-month open label studies. Eligible patients received no additional collagenase clostridium histolyticum treatment and were followed once yearly for up to 5 years to assess Peyronie's disease clinical symptoms, patient reported outcomes and safety.
RESULTS


Of 280 patients enrolled 204 (73%) completed the study. At baseline 247 patients had already experienced a mean±SD penile curvature decrease from 51.8±15.0 to 31.0±16.1 degrees (improvement of 20.9±16.2 degrees or 39.5%). At year 5 in 180 patients, despite no additional treatment, there was an additional 9.1% improvement in mean penile curvature compared with reference data (4.3±13.4 degrees, 95% CI 2.3-6.2, p <0.02). At baseline 183 patients experienced mean Peyronie's Disease Questionnaire bother domain score improvement from 6.5±3.5 to 3.4±3.3. At year 5 there was additional score improvement to 2.4±2.9 (p=0.0003). Adverse events were reported in 17.5% (49) of patients but no adverse events were considered treatment related. No long-term safety issues were identified up to 5 years after treatment. Long-term immunogenicity profiling showed a decreasing trend in the number of anti-AUX-I and anti-AUX-II seropositive cases at years 4 and 5 after collagenase clostridium histolyticum treatment.
CONCLUSIONS


Most patients treated with collagenase clostridium histolyticum continued to have penile curvature and Peyronie's Disease Questionnaire domain score improvements through year 5 without additional collagenase clostridium histolyticum treatment, and no additional safety signals were identified.",2020,"At Year 5, there was additional score improvement to 2.4±2.9 (p=0.0003).","['Patients', ""patients previously treated for Peyronie's disease (PD"", '280 patients enrolled, 204 (73%) completed the study']","['no additional CCH', 'collagenase clostridium histolyticum (CCH', 'CCH', 'placebo', 'Collagenase Clostridium Histolyticum']","['mean penile curvature decrease', ""mean Peyronie's Disease Questionnaire (PDQ) bother domain score improvement"", 'penile curvature and PDQ domain score improvements', 'mean penile curvature', 'Adverse events (AEs', 'number of anti-AUX-I and anti-AUX']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030848', 'cui_str': 'Peyronie Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009053', 'cui_str': 'collagenase Clostridium histolyticum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2938970', 'cui_str': 'Penile curvature'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030848', 'cui_str': 'Peyronie Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",280.0,0.0978339,"At Year 5, there was additional score improvement to 2.4±2.9 (p=0.0003).","[{'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Goldstein', 'Affiliation': 'Alvarado Hospital, San Diego, California.'}, {'ForeName': 'Larry I', 'Initials': 'LI', 'LastName': 'Lipshultz', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McLane', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Qinfang', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Genzhou', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Saji', 'Initials': 'S', 'LastName': 'Vijayan', 'Affiliation': 'Endo Pharmaceuticals Inc., Malvern, Pennsylvania.'}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Gelbard', 'Affiliation': 'Urology Associates Medical Group, Burbank, California.'}]",The Journal of urology,['10.1097/JU.0000000000000743']
3131,31760314,"Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial.","PURPOSE


This Phase IIb (NCT02195180) open-label study evaluated erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy in second-line advanced pancreatic adenocarcinoma.
METHODS


Eligible patients were randomized 2:1 to either eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm). Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) in patients with low asparagine synthetase (ASNS) expression. Secondary endpoints included OS and PFS in the entire population.
RESULTS


141 patients were randomized (eryaspase arm, n = 95; control arm, n = 46). Median OS and PFS in patients with low ASNS expression were 6.2 months (95% CI, 5.1-8.8) in the eryaspase arm versus 4.9 months (3.1-7.1) in the control arm (HR, 0.63; 95% CI, 0.39-1.01; P = 0.056) and 2.0 months (95% CI, 1.8-3.4) in the eryaspase arm versus 1.8 months (1.4-3.8) in the control arm (HR, 0.67; 95% CI, 0.40-1.12; P = 0.127), respectively. In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively. The combination of eryaspase and chemotherapy was well tolerated. The most frequent Grade 3/4 adverse events in the eryaspase arm (n = 93) were gamma-glutamyltransferase increase (16 [17.2%]), neutropenia (12 [12.9%]), and physical health deterioration (12 [12.9%]).
CONCLUSION


Eryaspase in combination with chemotherapy is associated with improvements in OS and PFS, irrespective of ASNS expression in second-line advanced pancreatic adenocarcinoma. A Phase III trial is underway.",2020,"In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively.","['141 patients', 'Eligible patients', 'patients with low asparagine synthetase (ASNS) expression', 'advanced pancreatic cancer', 'second-line advanced pancreatic adenocarcinoma']","['eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm', 'erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy', 'Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy']","['tolerated', 'overall survival (OS) and progression-free survival (PFS', 'gamma-glutamyltransferase increase', 'median OS and PFS', 'Median OS and PFS', 'OS and PFS in the entire population', 'physical health deterioration', 'neutropenia']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003997', 'cui_str': 'Asparagine Synthase'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0151662', 'cui_str': 'Gamma-glutamyl transferase raised (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",141.0,0.0757815,"In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Digestive and Medical Oncology Unit, Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris, University Denis Diderot Paris VII, 92110 Clichy, France. Electronic address: pascal.hammel@aphp.fr.'}, {'ForeName': 'Portales', 'Initials': 'P', 'LastName': 'Fabienne', 'Affiliation': 'Parc Euromedecine, 208 Rue Des Apothicaires, 34070 Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Institut Sainte Catherine, Gastrointestinal and Liver Cancer Unit, Chemin de Baigne Pieds, 84000 Avignon, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': 'CHRU de Brest - Hôpital Morvan, 2 Avenue Foch, 29609 Brest, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75012 Paris, and Sorbonne Universités, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'De La Fouchardiere', 'Affiliation': 'Medical Oncology Department, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Medical Oncology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014 Paris, France.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'El Hajbi', 'Affiliation': 'Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Les Oudairies, Hospital La Roche-Sur-Yon, Boulevard Stephane Moreau, 85000 La Roche Sur Yon, France.'}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Guimbaud', 'Affiliation': 'Institut Universitaire du Cancer, Avenue Hubert Curien, 31100 Toulouse, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Faculty of Medicine of Poitiers, 86000 Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': 'Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepatogastroenterology and Digestive Oncology, CHU de Tours, 37044 Tours Cedex, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rebischung', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble, 8 Rue Docteur Calmette, 38100 Grenoble, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': ""Service d'Oncologie médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Est, 94010 Créteil, France.""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon University Hospital, Department of Pathology-INSERM U1149, 100 Bvd Gal Lerclerc, 92110 Clichy, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kay', 'Affiliation': 'RK Statistics Ltd, St Giles View, Main Street, Great Longstone, Bakewell, DE45 1TZ, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hamm', 'Affiliation': 'Cytel Inc., 675 Massachusetts Ave Cambridge, MA 02139, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Universités, UPMC Université, Gastroenterology and Digestive Oncology Department, Pitié Salpêtrière Hospital, 75013 Paris, France.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'El Hariry', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.020']
3132,31970898,Sitting Balance Exercise Performed Using Virtual Reality Training on a Stroke Rehabilitation Inpatient Service: A Randomized Controlled Study.,"BACKGROUND


Virtual reality training (VRT) is engaging and may enhance rehabilitation intensity. Only one previous study has looked at its use to improve sitting balance after stroke.
OBJECTIVE


To determine if supplemental sitting balance exercises, administered via VRT, improve control of sitting balance and upper extremity function in stroke rehabilitation inpatients.
DESIGN


Assessor-blinded, placebo-controlled randomized controlled trial.
SETTING


Stroke inpatient rehabilitation unit.
PARTICIPANTS


Seventy-six participants (out of 130 approached) with subacute stroke who could not stand independently were randomized to experimental and control groups. Sixty-nine completed the study.
INTERVENTIONS


The experimental group did VRT that required leaning and reaching, whereas the control group had their trunk restrained and performed VRT that involved only small upper extremity movements to minimize trunk movement. Both groups performed 10-12 sessions of 30-45 minutes. Participants were assessed pre, post, and 1 month after the sessions by a blinded examiner.
OUTCOME MEASURES


Function in Sitting Test (FIST, primary outcome measure); Ottawa Sitting Scale; Reaching Performance Scale; Wolf Motor Function Test (WMFT).
RESULTS


Thirty-three participants completed the experimental intervention and 36 the control. Pre/post differences for FIST were 3.4 (confidence interval [CI] 0.5;6.3) for the experimental group and 5.3 (2.9;7.7) for the control group. There was a significant improvement over time (adjusted for multiple comparisons, P < .006) on most outcome measures except the WMFT Performance Time Scale (control group; P = .007) and grip strength (P = .008); there were no differences between groups (P > .006).
CONCLUSIONS


Siting balance outcomes were similar for both groups; therefore, this study does not support the use of sitting balance exercises provided via VRT for the rehabilitation of sitting balance after stroke. However, because it is only the second study to investigate VRT for sitting balance and upper extremity function, more research, using more challenging exercises and a greater treatment intensity, is required before definitive conclusions are made.",2020,"There was a significant improvement over time (adjusted for multiple comparisons, p<0.006) on most outcome measures excepting the WMFT Performance Time Scale (control group; p=0.007) and grip strength (p=0.008); there were no differences between groups (p>0.006).
","['stroke rehabilitation inpatients', 'Sixty-nine completed the study', 'Seventy-six participants (out of 130 approached) with sub-acute stroke who could not stand independently', 'Stroke inpatient rehabilitation unit', 'Thirty-three participants completed the experimental intervention and 36 the control']","['placebo', 'Sitting Balance Exercise Performed Using Virtual Reality Training', 'Virtual reality training (VRT', 'supplemental sitting balance exercises, administered via VRT']","['WMFT Performance Time Scale', 'sitting balance', 'grip strength', 'Function in Sitting Test (FIST, primary outcome measure); Ottawa Sitting Scale; Reaching Performance Scale; Wolf Motor Function Test (WMFT']","[{'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C4720842', 'cui_str': 'Function in sitting test (assessment scale)'}, {'cui': 'C0336667', 'cui_str': 'Fist, device (physical object)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",130.0,0.0809238,"There was a significant improvement over time (adjusted for multiple comparisons, p<0.006) on most outcome measures excepting the WMFT Performance Time Scale (control group; p=0.007) and grip strength (p=0.008); there were no differences between groups (p>0.006).
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sheehy', 'Affiliation': 'Bruyère Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Taillon-Hobson', 'Affiliation': 'Bruyère Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Sveistrup', 'Affiliation': 'Bruyère Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bilodeau', 'Affiliation': 'Bruyère Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Stroke Rehabilitation, Bruyère Continuing Care, Ottawa, Ontario, Canada.'}, {'ForeName': 'Hillel', 'Initials': 'H', 'LastName': 'Finestone', 'Affiliation': 'Stroke Rehabilitation, Bruyère Continuing Care, Ottawa, Ontario, Canada.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12331']
3133,31994641,Challenges and opportunities in the science of research to practice: lessons learned from a randomized controlled trial of a sexual risk-reduction intervention for psychiatric patients in a public mental health system.,"OBJECTIVE


Human immunodeficiency virus (HIV) prevention efficacy trials with psychiatric patients have been conducted in research settings in high-resourced countries, establishing short-term efficacy for reducing sexual risk behavior. None has been implemented within systems of care. In the last decade, overcoming this research-to-practice gap has become a focus of implementation science. This paper describes the first and only HIV Prevention intervention trial for psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers.
METHODS


The HIV Prevention intervention, which uses the Information-Motivation-Behavioral Skills model to achieve sexual risk-reduction, was rigorously adapted to the local context and clinic services' needs. Participants from eight clinics were randomized to HIV Prevention or Health Promotion conditions.
RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
CONCLUSION


Our trial was conducted before implementation studies became widely funded. Transporting an intervention to a new culture or into real-world practice settings may require adaptations. Our results demonstrate that clear guidelines are needed regarding whether to conduct efficacy, effectiveness, and/or implementation research as the most appropriate next step.
CLINICAL TRIAL REGISTRATION


NCT00881699.",2020,"RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
","['psychiatric patients', 'psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers', 'psychiatric patients in a public mental health system', 'Participants from eight clinics']","['HIV Prevention or Health Promotion conditions', 'sexual risk-reduction intervention']","['Information-Motivation-Behavioral domains', 'unprotected sex occasions']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}]",8.0,0.0553892,"RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
","[{'ForeName': 'Milton L', 'Initials': 'ML', 'LastName': 'Wainberg', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Claudio G', 'Initials': 'CG', 'LastName': 'Mann', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norcini-Pala', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKinnon', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Universidade Federal do Estado do Rio de Janeiro (UNIRIO), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Pinho', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Cavalcanti', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Leu', 'Initials': 'L', 'LastName': 'Cheng-Shiun', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Guimarães', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Palinkas', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Otto-Salaj', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Remien', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Cournos', 'Affiliation': 'Columbia University, New York, NY, USA.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0737']
3134,30049247,Client resistance predicts outcomes in cognitive-behavioral therapy for panic disorder.,"Objective:  Little is known about how therapy processes relate to outcome in cognitive-behavioral therapy (CBT) for panic disorder (PD). This study examined whether client resistance predicts CBT for PD outcomes beyond the effects of established pre-treatment predictors. A secondary aim was to assess the consistency of resistance over treatment.  Method:  Data were from 71 adults participating in up to 24 biweekly sessions of CBT in a randomized controlled trial. Panic severity was assessed before, during (at Weeks 1, 5, and 9), and at termination of treatment (Week 12) using the Panic Disorder Severity Scale. Trained coders reliably rated resistance in videos of Sessions 2 and 10 using the Client Resistance Code.  Results:  Resistance was found to be moderately consistent ( r  = .64). Although overall resistance was unrelated to outcomes, hierarchical linear modeling revealed that openly hostile resistance at Session 10 predicted significantly diminished symptom change ( r  = .28, CI 95%  = [.01, .51]), beyond the effects of pretreatment predictors. Hostile resistance at Session 2 predicted attrition ( r rb  = -.30,  p  = .001), even after established predictors were controlled.  Conclusions:  Although some forms of resistance may be benign, openly hostile resistance is an important therapy marker that warrants increased clinical and research attention.",2019,"Hostile resistance at Session 2 predicted attrition (r rb  = -.30, p = .001), even after established predictors were controlled.
","['Data were from 71 adults participating in up to 24 biweekly sessions of', 'panic disorder', 'panic disorder (PD']","['cognitive-behavioral therapy', 'cognitive-behavioral therapy (CBT', 'CBT']","['Panic Disorder Severity Scale', 'Hostile resistance', 'overall resistance', 'symptom change', 'Panic severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C3472215', 'cui_str': 'Panic disorder severity scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",71.0,0.0256618,"Hostile resistance at Session 2 predicted attrition (r rb  = -.30, p = .001), even after established predictors were controlled.
","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychology, University of Pennsylvania , Philadelphia , PA , USA.'}, {'ForeName': 'Dianne L', 'Initials': 'DL', 'LastName': 'Chambless', 'Affiliation': 'Department of Psychology, University of Pennsylvania , Philadelphia , PA , USA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'McCarthy', 'Affiliation': 'Department of Psychology, Chestnut Hill College , Philadelphia , PA , USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Milrod', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College , New\xa0York , NY , USA.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Gordon F.\xa0Derner, School of Psychology, Adelphi University , Garden City , NY , USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2018.1504174']
3135,32009005,The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study.,"OBJECTIVE


The twin block, a novel nerve block that blocks the deep temporal and masseteric branches of the trigeminal nerve, has been shown to be effective in the short-term management of masticatory myofascial pain. However, little is known about its effectiveness in long-term management. The objective of this study was to assess the efficacy of the twin block in comparison with trigger point injections for the treatment of masticatory myofascial pain.
STUDY DESIGN


Forty-eight patients age 18 to 89 years were randomly assigned to the twin block group (n = 23) or the trigger point injection group (n = 25). The final analysis was based on a total number of 40 patients.
RESULTS


Mean numerical pain intensity at baseline was 6.54 ± 1.90 for the trigger point injection group and 6.47 ± 2.23 for the twin block group. At the 6th month visit, it was 1.85 ± 1.85 for the trigger point injection group and 1.85 ± 1.94 for the twin block group. There were no statistically significant differences in pain intensity between the 2 groups at baseline (P = .64) and at the 6th month follow-up (P = .45).
CONCLUSIONS


The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03870191.",2020,"The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
","['patients with masticatory myofascial pain', 'Forty-eight patients age 18 to 89 years']",['trigger point injections'],"['masticatory myofascial pain', 'pain intensity', 'Mean numerical pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0185340', 'cui_str': 'Injection of trigger points (procedure)'}]","[{'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",48.0,0.124459,"The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
","[{'ForeName': 'Sowmya', 'Initials': 'S', 'LastName': 'Ananthan', 'Affiliation': 'Assistant Professor, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA. Electronic address: Ananths1@sdm.rutgers.edu.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Kanti', 'Affiliation': 'Predoctoral Student, University of Colorado School of Dental Medicine, Aurora, CO, USA.'}, {'ForeName': 'Julyana Gomes', 'Initials': 'JG', 'LastName': 'Zagury', 'Affiliation': 'Adjunct Faculty, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}, {'ForeName': 'Samuel Y P', 'Initials': 'SYP', 'LastName': 'Quek', 'Affiliation': 'Professor, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Benoliel', 'Affiliation': 'Professor and Associate Dean for Research, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2019.09.014']
3136,32178705,Effects of yoga on exercise capacity in patients with lymphangioleiomyomatosis: a nonrandomized controlled study.,"OBJECTIVE


To evaluate the effects of yoga on exercise capacity and quality of life in patients with lymphangioleiomyomatosis (LAM), a rare cystic lung disease in women.
PATIENTS AND METHODS


This was a nonrandomized, controlled study conducted in Beijing, China (August 27, 2017 - April 26, 2018). Twenty-six participants were allocated to the intervention (yoga) group (n = 13) or control group (n = 13). The yoga intervention involved a 24-week program of yoga class training for 90 min once a week and no fewer than 2 at-home sessions per week (at least 15 min per session). The 6-min walking distance (6MWD), lung function, serum vascular endothelial growth factor-D (VEGF-D) levels, quality of life, and symptoms of anxiety and depression were measured at baseline, 12-week and 24-week follow-up. An incremental cardiopulmonary exercise test was conducted at baseline and the 24-week follow-up.
RESULTS


Eleven patients completed the yoga training program. The yoga group exhibited improvements in the following outcomes versus those of the control group: 6MWD (+ 55 ± 29 m vs + 18 ± 49 m, P = 0.04), anaerobic threshold (3.4 ± 2.4 ml/min/kg vs 1.6 ± 1.4 ml/min/kg, P = 0.035) and peak work load (11.7 ± 14.6 W vs 0.2 ± 9.1 W, P = 0.027). There was no significant difference in peak oxygen consumption (VO 2 peak), lung function, VEGF-D level, and quality of life between the yoga and control groups. No adverse effects were found in the yoga group.
CONCLUSION


Yoga is a feasible and safe intervention for pulmonary rehabilitation and potentially improves exercise capacity in patients with LAM.
TRIAL REGISTRATION


(Clinical trial registration number at www.chictr.org.cn: ChiCTR-OON-1701274).",2020,"There was no significant difference in peak oxygen consumption (VO 2 peak), lung function, VEGF-D level, and quality of life between the yoga and control groups.","['patients with lymphangioleiomyomatosis', 'patients with lymphangioleiomyomatosis (LAM), a rare cystic lung disease in women', 'Eleven patients completed the yoga training program', 'patients with LAM', 'Beijing, China (August 27, 2017 - April 26, 2018', 'Twenty-six participants']","['Yoga', 'yoga']","['6-min walking distance (6MWD), lung function, serum vascular endothelial growth factor-D (VEGF-D) levels, quality of life, and symptoms of anxiety and depression', 'peak work load', 'peak oxygen consumption (VO 2 peak), lung function, VEGF-D level, and quality of life', 'exercise capacity and quality of life', 'anaerobic threshold', 'exercise capacity', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751674', 'cui_str': 'Lymphangioleiomyomatosis'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C1384901', 'cui_str': 'Cystic Disease Of Lung'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",26.0,0.0420858,"There was no significant difference in peak oxygen consumption (VO 2 peak), lung function, VEGF-D level, and quality of life between the yoga and control groups.","[{'ForeName': 'Xiangfeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Wenshuai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zu', 'Affiliation': 'Beijing Hexin Sunshine Sports Culture Co. Ltd, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'LAM Yoga Project, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Beijing Hexin Sunshine Sports Culture Co. Ltd, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Beijing Hexin Sunshine Sports Culture Co. Ltd, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'LAM Yoga Project, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of International Medical Service, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China. xukf@pumch.cn.'}]",Orphanet journal of rare diseases,['10.1186/s13023-020-1344-6']
3137,31778222,Impact of Intensive Blood Pressure Therapy on Concern about Falling: Longitudinal Results from the Systolic Blood Pressure Intervention Trial (SPRINT).,"OBJECTIVES


Concern about falling is common among older hypertension patients and could impact decisions to intensify blood pressure therapy. Our aim was to determine whether intensive therapy targeting a systolic blood pressure (SBP) of 120 mm Hg is associated with greater changes in concern about falling when compared with standard therapy targeting an SBP of 140 mm Hg.
DESIGN


Subsample analysis of participants randomized to either intensive or standard therapy in the Systolic Blood Pressure Intervention Trial (SPRINT).
SETTING


Approximately 100 outpatient sites.
PARTICIPANTS


A total of 2313 enrollees in SPRINT; participants were all age 50 or older (mean = 69 y) and diagnosed with hypertension.
MEASUREMENTS


Concern about falling was described by the shortened version of the Falls Efficacy Scale International as measured at baseline, 6 months, 1 year, and annually thereafter.
RESULTS


Concern about falling showed a small but significant increase over time among all hypertension patients. No differences were noted, however, among those randomized to intensive vs standard therapy (P = .95). Among participants younger than 75 years, no increase in concern about falling over time was noted, but among participants aged 75 years and older, the mean falls self-efficacy score increased by .3 points per year (P < .0001). No differences were observed between the intensive and standard treatment groups when stratified by age (P = .55).
CONCLUSION


Intensive blood pressure therapy is not associated with increased concern about falling among older hypertension patients healthy enough to participate in SPRINT. J Am Geriatr Soc 68:614-618, 2020.",2020,"No differences were observed between the intensive and standard treatment groups when stratified by age (P = .55).
","['participants younger than 75\u2009years', 'A total of 2313 enrollees in SPRINT; participants were all age 50 or older (mean = 69\u2009y) and diagnosed with hypertension', 'Approximately 100 outpatient sites', 'older hypertension patients', 'older hypertension patients healthy']","['Intensive blood pressure therapy', 'Intensive Blood Pressure Therapy', 'intensive or standard therapy', 'intensive therapy']","['systolic blood pressure (SBP', 'mean falls self-efficacy score', 'concern about falling over time', 'Falls Efficacy Scale International']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}]",2313.0,0.0996755,"No differences were observed between the intensive and standard treatment groups when stratified by age (P = .55).
","[{'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford VA Hospital, Bedford, University of Massachusetts Lowell, Lowell, Massachusetts.'}, {'ForeName': 'Capri', 'Initials': 'C', 'LastName': 'Foy', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Conroy', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Evans', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Olney', 'Affiliation': 'Research Service, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pisoni', 'Affiliation': 'Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston, South Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Powell', 'Affiliation': 'Division of General Internal Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Ohio State Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Ronald I', 'Initials': 'RI', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall VA Medical Center, University of Florida, Gainesville, Florida.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16264']
3138,29336265,Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial.,"BACKGROUND


Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFU.
METHODS


Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.
RESULTS


At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.
CONCLUSION


Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.",2019,"However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth.","['Diabetic Foot Ulcer', 'Diabetic foot ulcer (DFU', 'Forty patients with DFU enrolled in a double-blind randomized clinical trial', 'diabetic patients']","['topical Placebo gel', 'topical Plantavera gel', 'Aloe vera/ Plantago Major Gel', 'Aloe vera/ Plantago major gel (Plantavera gel']","['ulcer surface', 'total ulcer score']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0002168', 'cui_str': 'Aloe'}, {'cui': 'C0946846', 'cui_str': 'Plantain'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0419567,"However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth.","[{'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Najafian', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra M', 'Initials': 'ZM', 'LastName': 'Khorasani', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mona N', 'Initials': 'MN', 'LastName': 'Najafi', 'Affiliation': 'Clinical Research Unit, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shokouh S', 'Initials': 'SS', 'LastName': 'Hamedi', 'Affiliation': 'Department of Persian Pharmacy, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mahjour', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Feyzabadi', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Current drug discovery technologies,['10.2174/1570163815666180115093007']
3139,31936519,Effect of Chinese Propolis as an Intracanal Medicament on Post-Operative Endodontic Pain: A Double-Blind Randomized Controlled Trial.,"Propolis is a potent anti-microbial and natural anti-inflammatory by-product obtained from the beehive. Studies have demonstrated the superior biocompatibility and anti-microbial properties of propolis as compared to calcium hydroxide. However, its effect on postoperative endodontic pain is unknown. Therefore, this study aimed to investigate the impact of Chinese propolis paste as an intracanal medicament on postoperative endodontic pain intensities compared with calcium hydroxide (control) at different time intervals in necrotic teeth with periapical radiolucency. Eighty patients with single-rooted necrotic teeth with visible periapical radiolucency were recruited and randomly allocated to either the calcium hydroxide or propolis groups. After chemo-mechanical preparation and intracanal medicament insertion, patients were given the VAS (visual analogue scale) to record pain scores. Inter-group data were compared and analyzed using two-way repeated measure ANOVA (Bonferroni test). A  p -value of < 0.025 was considered significant. In total, >78% of the patients experienced no or only mild post-operative pain in both the groups at all time intervals, without any significant difference in pain scores between the two groups ( p  > 0.025). An overall flare-up rate of 14.8% was found. The results suggest that either of these medicaments can be used as an inter-appointment medication for the prevention of postoperative pain in necrotic cases.",2020,"In total, >78% of the patients experienced no or only mild post-operative pain in both the groups at all time intervals, without any significant difference in pain scores between the two groups ( p  > 0.025).","['Eighty patients with single-rooted necrotic teeth with visible periapical radiolucency', 'necrotic teeth with periapical radiolucency', 'Post-Operative Endodontic Pain']","['calcium hydroxide (control', 'calcium hydroxide or propolis groups', 'calcium hydroxide', 'Chinese propolis paste', 'Chinese Propolis']","['postoperative endodontic pain', 'pain scores', 'mild post-operative pain', 'VAS (visual analogue scale) to record pain scores', 'postoperative endodontic pain intensities']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0729269', 'cui_str': 'Periapical (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",80.0,0.134839,"In total, >78% of the patients experienced no or only mild post-operative pain in both the groups at all time intervals, without any significant difference in pain scores between the two groups ( p  > 0.025).","[{'ForeName': 'Juzer', 'Initials': 'J', 'LastName': 'Shabbir', 'Affiliation': 'Department of Operative Dentistry & Endodontics, Dow International Dental College, Dow University of Health Sciences, Karachi 74200, Pakistan.'}, {'ForeName': 'Fazal', 'Initials': 'F', 'LastName': 'Qazi', 'Affiliation': 'Department of Operative Dentistry & Endodontics, Dr. Ishrat-ul-ibad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi 72400, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Farooqui', 'Affiliation': 'School of Public Health, Dow University of Health Sciences, Karachi 74200, Pakistan.'}, {'ForeName': 'Shahbaz', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Department of Operative Dentistry & Endodontics, Dr. Ishrat-ul-ibad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi 72400, Pakistan.'}, {'ForeName': 'Tazeen', 'Initials': 'T', 'LastName': 'Zehra', 'Affiliation': 'Liaquat College of Medicine and Dentistry, Operative Dentistry Department, Karachi 75290, Pakistan.'}, {'ForeName': 'Zohaib', 'Initials': 'Z', 'LastName': 'Khurshid', 'Affiliation': 'Department of Prosthodontics and Dental Implantology, College of Dentistry, King Faisal University, Al Ahsa 31982, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph17020445']
3140,31940865,The Effect of Psychological First Aid Training on Knowledge and Understanding about Psychosocial Support Principles: A Cluster-Randomized Controlled Trial.,"Psychological first aid (PFA) is a world-wide implemented approach to helping people affected by an emergency, disaster, or other adverse event. Controlled evaluations of PFA's training effects are lacking. We evaluated the effectiveness of a one-day PFA training on the acquisition and retention of knowledge of appropriate responses and skills in the acute aftermath of adversity in Peripheral Health Units (PHUs) in post-Ebola Sierra Leone. Secondary outcomes were professional quality of life, confidence in supporting a distressed person, and professional attitude. PHUs in Sierra Leone ( n  = 129) were cluster-randomized across PFA (206 participants) and control (202 participants) in March 2017. Knowledge and understanding of psychosocial support principles and skills were measured with a questionnaire and two patient scenarios to which participants described helpful responses. Professional attitude, confidence, and professional quality of life were assessed using self-report instruments. Assessments took place at baseline and at three- and six-months post-baseline. The PFA group had a stronger increase in PFA knowledge and understanding at the post-PFA training assessment (d = 0.50;  p  < 0.001) and at follow-up (d = 0.43;  p  = 0.001). In addition, the PFA group showed better responses to the scenarios at six-months follow-up (d = 0.38;  p  = 0.0002) but not at the post-assessment (d = 0.04;  p  = 0.26). No overall significant differences were found for professional attitude, confidence, and professional quality of life. In conclusion, PFA training improved acquisition and retention of knowledge and understanding of appropriate psychosocial responses and skills in providing support to individuals exposed to acute adversity. Our data support the use of PFA trainings to strengthen capacity for psychosocial support in contexts of disaster and humanitarian crisis. Future studies should examine the effects of PFA on psychosocial outcomes for people affected by crises.",2020,"No overall significant differences were found for professional attitude, confidence, and professional quality of life.","['PHUs in Sierra Leone ( n  ', '129) were cluster-randomized across PFA (206 participants) and control (202 participants) in March 2017']","['Psychological First Aid Training', 'PFA training', 'Psychological first aid (PFA', 'PFA trainings', 'PFA']","['Professional attitude, confidence, and professional quality of life', 'PFA knowledge', 'acquisition and retention of knowledge and understanding of appropriate psychosocial responses and skills', 'professional quality of life, confidence in supporting a distressed person, and professional attitude', 'professional attitude, confidence, and professional quality of life']","[{'cui': 'C0037063', 'cui_str': 'Republic of Sierra Leone'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0016143', 'cui_str': 'First Aid'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034380'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",206.0,0.0434983,"No overall significant differences were found for professional attitude, confidence, and professional quality of life.","[{'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sijbrandij', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, World Health Organization Collaborating Center for Research and Dissemination of Psychological Interventions, Amsterdam Public Health Research Institute, Vrije Universiteit, 1081 BT Amsterdam, The Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Horn', 'Affiliation': 'Institute for Global Health and Development, Queen Margaret University, Edinburgh EH21 6UU, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Esliker', 'Affiliation': 'Department of Counselling Psychology, University of Makeni, Freetown, Makeni PO Box 2, Northern Province, Sierra Leone.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': ""O'May"", 'Affiliation': 'Institute for Global Health and Development, Queen Margaret University, Edinburgh EH21 6UU, UK.'}, {'ForeName': 'Relinde', 'Initials': 'R', 'LastName': 'Reiffers', 'Affiliation': 'ARQ International, ARQ National Psychotrauma Centre, 1112 XE Diemen, The Netherlands.'}, {'ForeName': 'Leontien', 'Initials': 'L', 'LastName': 'Ruttenberg', 'Affiliation': 'International Medical Relief Services (IMRES), 8200 AE Lelystad, The Netherlands.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Stam', 'Affiliation': 'ARQ International, ARQ National Psychotrauma Centre, 1112 XE Diemen, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'de Jong', 'Affiliation': 'Amsterdam University Medical Centre, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Ager', 'Affiliation': 'Institute for Global Health and Development, Queen Margaret University, Edinburgh EH21 6UU, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17020484']
3141,31941792,Single- versus double-injection costoclavicular block: a randomized comparison.,"BACKGROUND


The costoclavicular approach targets the brachial plexus in the proximal infraclavicular fossa, where the lateral, medial, and posterior cords are tightly bundled together. This randomized trial compared single- and double-injection ultrasound-guided costoclavicular blocks. We selected onset time as the primary outcome and hypothesized that, compared with its single-injection counterpart, the double-injection technique would result in a swifter onset.
METHODS


Ninety patients undergoing upper limb surgery (at or below the elbow joint) were randomly allocated to receive a single- (n=45) or double-injection (n=45) ultrasound-guided costoclavicular block. The local anesthetic agent (35 mL of lidocaine 1%-bupivacaine 0.25%with epinephrine 5 µg/mL and 2 mg of preservative-free dexamethasone) was identical in all subjects. In the single-injection group, the entire volume of local anesthetic was injected between the three cords of the brachial plexus. In the double-injection group, the first half of the volume was administered in this location; the second half was deposited between the medial cord and the subclavian artery. After the performance of the block, a blinded observer recorded the onset time (defined as the time required to achieve a minimal sensorimotor composite score of 14 out of 16 points), success rate (surgical anesthesia) and block-related pain scores. Performance time and the number of needle passes were also recorded during the performance of the block. The total anesthesia-related time was defined as the sum of the performance and onset times.
RESULTS


Compared with its single-injection counterpart, the double-injection technique displayed shorter onset time (16.6 (6.4) vs 23.4 (6.9) min; p<0.001; 95% CI for difference 3.9 to 9.7) and total anesthesia-related time (22.5 (6.7) vs 28.9 (7.6) min; p<0.001). No intergroup differences were found in terms of success and technical execution (ie, performance time/procedural pain). The double-injection group required more needle passes than the single-injection group (2 (1-4) vs 1 (1-3); p<0.001).
CONCLUSION


Compared with its single-injection counterpart, double-injection costoclavicular block results in shorter onset and total anesthesia-related times. Further investigation is required to determine if a triple-injection technique (with targeted local anesthetic injection around each cord of the brachial plexus) could further decrease the onset time.
TRIAL REGISTRATION NUMBER


NCT03595514.",2020,"No intergroup differences were found in terms of success and technical execution (ie, performance time/procedural pain).",['Ninety patients undergoing upper limb surgery (at or below the elbow joint'],"['single- and double-injection ultrasound-guided costoclavicular blocks', 'lidocaine 1%-bupivacaine 0.25%with epinephrine 5\u2009µg/mL and 2\u2009mg of preservative-free dexamethasone', 'single- (n=45) or double-injection (n=45) ultrasound-guided costoclavicular block', 'Single- versus double-injection costoclavicular block']","['total anesthesia-related time', 'onset time', 'needle passes', 'Performance time and the number of needle passes', 'entire volume of local anesthetic', 'shorter onset and total anesthesia-related times', 'success rate (surgical anesthesia) and block-related pain scores', 'success and technical execution (ie, performance time/procedural pain']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013770', 'cui_str': 'Elbow Joint'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}]",90.0,0.298183,"No intergroup differences were found in terms of success and technical execution (ie, performance time/procedural pain).","[{'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile julian.aliste@uchile.cl.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'García', 'Affiliation': 'Orthopedic Surgery, University of Chile, Santiago, Chile.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Anesthesiology, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'De Q', 'Initials': 'DQ', 'LastName': 'Tran', 'Affiliation': 'Anesthesiology, McGill University, Montreal, Québec, Canada.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2019-101167']
3142,31564599,"Cluster Randomized Trial of Teens Against Tobacco Use: Youth Empowerment for Tobacco Control in El Paso, Texas.","INTRODUCTION


This study examines smoke-free youth partnerships implementing the Teens Against Tobacco Use model developed by the American Lung Association. This innovative tobacco prevention strategy has not been evaluated rigorously. Students used peer teaching to educate youth about tobacco use and engaged in tobacco control advocacy activities. Participating high school and middle school youth were trained to develop and deliver tobacco prevention presentations to 4th-8th grade students in schools.
STUDY DESIGN


To evaluate the efficacy of the presentations, matched pairs of classrooms willing to have 1 presentation were randomly assigned to receive either the presentation first (intervention condition) or later in the school year (control condition).
SETTING/PARTICIPANTS


The study took place in a predominantly low-income Hispanic community. A total of 9 schools, 107 classes, and 2,257 students participated in the evaluation.
MAIN OUTCOME MEASURES


Tobacco susceptibility was assessed with a brief survey administered to students in both intervention and control classrooms in 2014 and 2015 after the completion of presentations in intervention classrooms. Analyses completed in 2019 compared intervention and control classrooms on tobacco susceptibility.
RESULTS


Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility. Teens Against Tobacco Use presenters also completed tobacco retailer compliance checks and gained media coverage in advocating to regulate e-cigarettes in the same manner as other tobacco products.
CONCLUSIONS


Findings suggest Teens Against Tobacco Use is an effective means of reducing tobacco susceptibility among 4th-8th graders in the immediate term. Longer-term outcome evaluations are needed to determine whether Teens Against Tobacco Use presentations can have a lasting impact on tobacco use.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02443025.",2019,"RESULTS


Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility.","['matched pairs of classrooms willing to have 1 presentation', 'A total of 9 schools, 107 classes, and 2,257 students participated in the evaluation', 'Teens Against Tobacco Use: Youth Empowerment for Tobacco Control in El Paso, Texas', 'Participating high school and middle school youth were trained to develop and deliver tobacco prevention presentations to 4th-8th grade students in schools', 'predominantly low-income Hispanic community']","['presentation first (intervention condition) or later in the school year (control condition', 'peer teaching to educate youth about tobacco use and engaged in tobacco control advocacy activities']","['tobacco susceptibility scores', 'tobacco susceptibility']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",107.0,0.0425585,"RESULTS


Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility.","[{'ForeName': 'Louis D', 'Initials': 'LD', 'LastName': 'Brown', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, University of Texas Health Science Center at Houston, School of Public Health, El Paso, Texas. Electronic address: louis.d.brown@uth.tmc.edu.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Bandiera', 'Affiliation': 'Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Harrell', 'Affiliation': 'Department of Epidemiology, Human Genetics, and Environmental Sciences, University of Texas Health Science Center at Houston, School of Public Health, Austin, Texas.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.06.013']
3143,30190343,"ABVD plus rituximab  versus  ABVD alone for advanced stage, high-risk classical Hodgkin lymphoma: a randomized phase 2 study.",,2019,,"['advanced stage, high-risk classical Hodgkin lymphoma']",['ABVD plus rituximab  versus  ABVD alone'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.0418864,,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Strati', 'Affiliation': 'Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Fanale', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Oki', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Turturro', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Fayad', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Hematology and Oncology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Gladstone', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Yvette L', 'Initials': 'YL', 'LastName': 'Kasamon', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Portlock', 'Affiliation': 'Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': 'Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Goy', 'Affiliation': 'Lymphoma Division, John Theurer Cancer Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Hun Ju', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX hunlee@mdanderson.org.'}]",Haematologica,['10.3324/haematol.2018.199844']
3144,31647325,A randomized evaluation of on-site monitoring nested in a multinational randomized trial.,"BACKGROUND


Evidence from prospectively designed studies to guide on-site monitoring practices for randomized trials is limited. A cluster randomized study, nested within the Strategic Timing of AntiRetroviral Treatment (START) trial, was conducted to evaluate on-site monitoring.
METHODS


Sites were randomized to either annual on-site monitoring or no on-site monitoring. All sites were centrally monitored, and local monitoring was carried out twice each year. Randomization was stratified by country and projected enrollment in START. The primary outcome was a participant-level composite outcome including components for eligibility errors, consent violations, use of antiretroviral treatment not recommended by protocol, late reporting of START primary and secondary clinical endpoints (defined as the event being reported more than 6 months from occurrence), and data alteration and fraud. Logistic regression fixed effect hierarchical models were used to compare on-site versus no on-site monitoring for the primary composite outcome and its components. Odds ratios and 95% confidence intervals comparing on-site monitoring versus no on-site monitoring are cited.
RESULTS


In total, 99 sites (2107 participants) were randomized to receive annual on-site monitoring and 97 sites (2264 participants) were randomized to be monitored only centrally and locally. The two monitoring groups were well balanced at entry. In the on-site monitoring group, 469 annual on-site monitoring visits were conducted, and 134 participants (6.4%) in 56 of 99 sites (57%) had a primary monitoring outcome. In the no on-site monitoring group, 85 participants (3.8%) in 34 of 97 sites (35%) had a primary monitoring outcome (odds ratio = 1.7; 95% confidence interval: 1.1-2.7; p = 0.03). Informed consent violations accounted for most outcomes in each group (56 vs 41 participants). The largest odds ratio was for eligibility violations (odds ratio = 12.2; 95% confidence interval: 1.8-85.2; p = 0.01). The number of participants with a late START primary endpoint was similar for each monitoring group (23 vs 16 participants). Late START grade 4 and unscheduled hospitalization events were found for 34 participants in the on-site monitoring group and 19 participants in the no on-site monitoring group (odds ratio = 2.0; 95% confidence interval: 1.1-3.7; p = 0.02). There were no cases of data alteration or fraud. Based on the travel budget for on-site monitoring and the hours spent conducting on-site monitoring, the estimated cost of on-site monitoring was over US$2 million.
CONCLUSION


On-site monitoring led to the identification of more eligibility and consent violations and START clinical events being reported more than 6 months from occurrence as compared to no on-site monitoring. Considering the nature of the excess monitoring outcomes identified at sites receiving on-site monitoring, as well as the cost of on-site monitoring, the value to the START study was limited.",2020,Late START grade 4 and unscheduled hospitalization events were found for 34 participants in the on-site monitoring group and 19 participants in the no on-site monitoring group (odds ratio = 2.0; 95% confidence interval: 1.1-3.7; p = 0.02).,"['In total, 99 sites (2107 participants) were randomized to receive annual on-site monitoring and 97 sites (2264 participants']",[],"['participant-level composite outcome including components for eligibility errors, consent violations, use of antiretroviral treatment not recommended by protocol, late reporting of START primary and secondary clinical endpoints (defined as the event being reported more than 6\u2009months from occurrence), and data alteration and fraud', 'Late START grade 4 and unscheduled hospitalization events']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0016684', 'cui_str': 'Fraud'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",2264.0,0.0755409,Late START grade 4 and unscheduled hospitalization events were found for 34 participants in the on-site monitoring group and 19 participants in the no on-site monitoring group (odds ratio = 2.0; 95% confidence interval: 1.1-3.7; p = 0.02).,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wyman Engen', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Huppler Hullsiek', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Waldo H', 'Initials': 'WH', 'LastName': 'Belloso', 'Affiliation': 'CICAL and Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Finley', 'Affiliation': 'Washington Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Hudson', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Denning', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Carey', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kagan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519881616']
3145,31704275,Can mild cognitive impairment be stabilized by showering brain mitochondria with laser photons?,"There is now substantial evidence that cerebral blood flow (CBF) declines with age. From age 20 to 60, CBF is estimated to dip about 16% and continues to drop at a rate of 0.4%/year. This CBF dip will slowly reduce oxygen/glucose delivery to brain thus lowering ATP energy production needed by brain cells to perform normal activities. Reduced ATP production from mitochondrial loss or damage in the wear-and-tear of aging worsens when vascular risk factors (VRF) to Alzheimer's disease develop that can accelerate both age-decline CBF and mitochondrial deficiency to a level where mild cognitive impairment (MCI) develops. To date, no pharmacological or any other treatment has been successful in reversing, stabilizing or delaying MCI. For the first time in medical interventions, a non-pharmacological, non-invasive, well-tolerated, easy to perform, free of significant side effects and cost-effective treatment may achieve what virtually all AD treatments in the past have been unable to accomplish. This intervention uses transcranial infrared brain stimulation (TIBS), a form of photobiomodulation (PBM). PBM is a bioenergetic non-ionizing, therapeutic approach using low level light emission from laser or light emitting diodes. PBM has been used in a number of neurological conditions including Parkinson's disease, depression, traumatic brain injury, and stroke with diverse reported benefits. This brief review examines the impact of reduced energy supply stemming from chronic brain hypoperfusion in the aging brain. In this context, the use of TIBS is planned in a randomized, placebo-controlled study of MCI patients to be done at our University Clinic. This article is part of the special issue entitled 'The Quest for Disease-Modifying Therapies for Neurodegenerative Disorders'.",2020,Reduced ATP production from mitochondrial loss or damage in the wear-and-tear of aging worsens when vascular risk factors (VRF) to Alzheimer's disease develop that can accelerate both age-decline CBF and mitochondrial deficiency to a level where mild cognitive impairment (MCI) develops.,[],"['placebo', 'MCI', 'PBM']",['cerebral blood flow (CBF) declines'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",,0.0273785,Reduced ATP production from mitochondrial loss or damage in the wear-and-tear of aging worsens when vascular risk factors (VRF) to Alzheimer's disease develop that can accelerate both age-decline CBF and mitochondrial deficiency to a level where mild cognitive impairment (MCI) develops.,"[{'ForeName': 'Jack C', 'Initials': 'JC', 'LastName': 'de la Torre', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, TX, 78712, USA; Department of Physiology, University of Valencia, Valencia, 46010, Spain. Electronic address: jcdelatorre23@yahoo.com.'}, {'ForeName': 'Antonio Del', 'Initials': 'AD', 'LastName': 'Olmo', 'Affiliation': 'Neurology Section, Hospital Universitario Dr. Peset, Valencia, 46017, Spain.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Valles', 'Affiliation': 'Department of Physiology, University of Valencia, Valencia, 46010, Spain.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.107841']
3146,31420383,Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial.,"INTRODUCTION


Congenital heart disease (CHD) is a major cause of infant mortality. Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB). CPB triggers a systemic inflammatory response which is associated with low cardiac output syndrome (LCOS), postoperative morbidity and mortality. Delivery of nitric oxide (NO) into CPB circuits can provide myocardial protection and reduce bypass-induced inflammation, leading to less LCOS and improved recovery. We hypothesised that using NO during CPB increases ventilator-free days (VFD) (the number of days patients spend alive and free from invasive mechanical ventilation up until day 28) compared with standard care. Here, we describe the NITRIC trial protocol.
METHODS AND ANALYSIS


The NITRIC trial is a randomised, double-blind, controlled, parallel-group, two-sided superiority trial to be conducted in six paediatric cardiac surgical centres. One thousand three-hundred and twenty infants <2 years of age undergoing cardiac surgery with CPB will be randomly assigned to NO at 20 ppm administered into the CPB oxygenator for the duration of CPB or standard care (no NO) in a 1:1 ratio with stratification by age (<6 and ≥6 weeks), single ventricle physiology (Y/N) and study centre. The primary outcome will be VFD to day 28. Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs. Analyses will be conducted on an intention-to-treat basis. Preplanned secondary analyses will investigate the impact of NO on host inflammatory profiles postsurgery.
ETHICS AND DISSEMINATION


The study has ethical approval (HREC/17/QRCH/43, dated 26 April 2017), is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000821392) and commenced recruitment in July 2017. The primary manuscript will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ACTRN12617000821392.",2019,"Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs.","['six paediatric cardiac surgical centres', 'Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB', 'Infants with Congenital heart defects (NITRIC trial', 'One thousand three-hundred and twenty infants <2\u2009years of age undergoing cardiac surgery with CPB']","['nitric oxide (NO) into CPB circuits', 'CPB oxygenator for the duration of CPB or standard care (no NO', 'NITric oxide during cardiopulmonary bypass']","['VFD to day 28', 'composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0018798', 'cui_str': 'Heart Abnormalities'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030067', 'cui_str': 'Oxygenators'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085559'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",1320.0,0.442133,"Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs.","[{'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Stephen Brian', 'Initials': 'SB', 'LastName': 'Horton', 'Affiliation': ""Cardiac Surgical Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Debbie Amanda', 'Initials': 'DA', 'LastName': 'Long', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Beca', 'Affiliation': ""Paediatric Intensive Care Unit, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Erickson', 'Affiliation': ""Paediatric Critical Care, Perth Children's Hospital, Western Australia and The University of Western Australia, Crawley, Western Australia, Australia.""}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Festa', 'Affiliation': ""Kids Critical Care Research, Paediatric Intensive Care Unit, Children's Hospital at Westmead, Westmead, New South Wales, Australia.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': ""d'Udekem"", 'Affiliation': ""Department of Cardiac Surgery, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Alphonso', 'Affiliation': ""Cardiac Surgery, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Winlaw', 'Affiliation': ""Heart Centre for Children, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.""}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Delzoppo', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Loon', 'Affiliation': 'Division of Anaesthetics, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gannon', 'Affiliation': 'Centre for the Business and Economics of Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Fooken', 'Affiliation': 'Centre for the Business and Economics of Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blumenthal', 'Affiliation': 'The Infection and Inflammation Group, The University of Queensland Diamantina Institute, The University of Queensland, Translational Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'The Intensive Care Research Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, Bond University, Gold Coast, Brisbane, Australia.'}, {'ForeName': 'Warwick', 'Initials': 'W', 'LastName': 'Butt', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-026664']
3147,31362785,"Local ice cryotherapy decreases synovial interleukin 6, interleukin 1β, vascular endothelial growth factor, prostaglandin-E2, and nuclear factor kappa B p65 in human knee arthritis: a controlled study.","BACKGROUND


The aim of this study was to assess the anti-inflammatory effects of local cryotherapy in human non-septic knee arthritis.
METHODS


In the phase I of the study, patients were randomized to receive either ice (30 min; N = 16) or cold CO 2  (2 min; N = 16) applied twice during 1 day at an 8-h interval on the arthritic knee. In phase II, 16 other ice-treated arthritic knees according to the same protocol were compared to the contralateral non-treated arthritic knees (N = 16). The synovial fluid was analyzed just before the first cold application, then 24 h later. IL-6, IL-1β, TNF-α, IL-17A, VEGF, NF-kB-p65 protein, and PG-E2 levels were measured in the synovial fluid and compared before/after the two cold applications.
RESULTS


Forty-seven patients were included (17 gouts, 11 calcium pyrophosphate deposition diseases, 13 rheumatoid arthritides, 6 spondyloarthritides). Local ice cryotherapy significantly reduced the IL-6, IL-1β, VEGF, NF-kB-p65, and PG-E2 synovial levels, especially in the microcrystal-induced arthritis subgroup, while only phosphorylated NF-kB-p65 significantly decreased in rheumatoid arthritis and spondyloarthritis patients. Cold CO 2  only reduced the synovial VEGF levels. In the phase II of the study, the synovial PG-E2 was significantly reduced in ice-treated knees, while it significantly increased in the corresponding contralateral non-treated arthritic knees, with a significant inter-class effect size (mean difference - 1329 [- 2232; - 426] pg/mL; N = 12).
CONCLUSIONS


These results suggest that local ice cryotherapy reduces IL-6, IL-1β, and VEGF synovial protein levels, mainly in microcrystal-induced arthritis, and potentially through NF-kB and PG-E2-dependent mechanisms.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03850392-registered February 20, 2019-retrospectively registered.",2019,"Local ice cryotherapy significantly reduced the IL-6, IL-1β, VEGF, NF-kB-p65, and PG-E2 synovial levels, especially in the microcrystal-induced arthritis subgroup, while only phosphorylated NF-kB-p65 significantly decreased in rheumatoid arthritis and spondyloarthritis patients.","['human non-septic knee arthritis', 'Forty-seven patients were included (17 gouts, 11 calcium pyrophosphate deposition diseases, 13 rheumatoid arthritides, 6 spondyloarthritides', 'human knee arthritis']","['cold CO', 'local cryotherapy', 'Local ice cryotherapy']","['IL-6, IL-1β, VEGF, NF-kB-p65, and PG-E2 synovial levels', 'IL-6, IL-1β, TNF-α, IL-17A, VEGF, NF-kB-p65 protein, and PG-E2 levels', 'synovial VEGF levels', 'IL-6, IL-1β, and VEGF synovial protein levels', 'synovial interleukin 6, interleukin 1β, vascular endothelial growth factor, prostaglandin-E2, and nuclear factor kappa B p65', 'synovial PG-E2']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0553730', 'cui_str': 'Pseudogout'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0079904', 'cui_str': 'Nuclear Factor-Kappab'}, {'cui': 'C0299809', 'cui_str': 'p65(PAK)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}]",47.0,0.0480542,"Local ice cryotherapy significantly reduced the IL-6, IL-1β, VEGF, NF-kB-p65, and PG-E2 synovial levels, especially in the microcrystal-induced arthritis subgroup, while only phosphorylated NF-kB-p65 significantly decreased in rheumatoid arthritis and spondyloarthritis patients.","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Guillot', 'Affiliation': 'Department of Rheumatology, Felix Guyon University Hospital, Saint-Denis, Reunion, France. xavier.guillot@chu-reunion.fr.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tordi', 'Affiliation': 'PEPITE EA4267, FHU INCREASE, Bourgogne-Franche-Comté University, Besançon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Laheurte', 'Affiliation': 'INSERM U1098, Biomonitoring Platform, EFS, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pazart', 'Affiliation': 'CIC IT, INSERM Center CIT 808, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Prati', 'Affiliation': 'PEPITE EA4267, FHU INCREASE, Bourgogne-Franche-Comté University, Besançon, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Saas', 'Affiliation': 'INSERM U1098, Biomonitoring Platform, EFS, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Department of Rheumatology, Besançon university hospital, Besançon, France.'}]",Arthritis research & therapy,['10.1186/s13075-019-1965-0']
3148,31104069,Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial.,"Importance


Previous research suggested that soluble human recombinant thrombomodulin may reduce mortality among patients with sepsis-associated coagulopathy.
Objective


To determine the effect of human recombinant thrombomodulin vs placebo on 28-day all-cause mortality among patients with sepsis-associated coagulopathy.
Design, Setting, and Participants


The SCARLET trial was a randomized, double-blind, placebo-controlled, multinational, multicenter phase 3 study conducted in intensive care units at 159 sites in 26 countries. All adult patients admitted to one of the participating intensive care units between October 2012 and March 2018 with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure, defined as an international normalized ratio greater than 1.40 without other known etiology and a platelet count in the range of 30 to 150 × 109/L or a greater than 30% decrease in platelet count within 24 hours, were considered for inclusion. The final date of follow-up was February 28, 2019.
Interventions


Patients with sepsis-associated coagulopathy were randomized and treated with an intravenous bolus or a 15-minute infusion of thrombomodulin (0.06 mg/kg/d [maximum, 6 mg/d]; n = 395) or matching placebo (n = 405) once daily for 6 days.
Main Outcome and Measures


The primary end point was 28-day all-cause mortality.
Results


Among 816 randomized patients, 800 (mean age, 60.7 years; 437 [54.6%] men) completed the study and were included in the full analysis set. In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P = .32). The absolute risk difference was 2.55% (95% CI, -3.68% to 8.77%). The incidence of serious major bleeding adverse events (defined as any intracranial hemorrhage; life-threatening bleeding; or bleeding event classified as serious by the investigator, with administration of at least 1440 mL [typically 6 units] of packed red blood cells over 2 consecutive days) was 23 of 396 patients (5.8%) in the thrombomodulin group and 16 of 404 (4.0%) in the placebo group.
Conclusions and Relevance


Among patients with sepsis-associated coagulopathy, administration of a human recombinant thrombomodulin, compared with placebo, did not significantly reduce 28-day all-cause mortality.
Trial Registration


ClinicalTrials.gov Identifier: NCT01598831.",2019,"In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P = .32).","['All adult patients admitted to one of the participating intensive care units between October 2012 and March 2018 with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure, defined as an international normalized ratio greater than 1.40 without other known etiology and a platelet count in the range of 30 to 150\u2009×\u2009109/L or a greater than 30% decrease in platelet count within 24 hours, were considered for inclusion', 'Patients with sepsis-associated coagulopathy', 'patients with sepsis-associated coagulopathy', '816 randomized patients, 800 (mean age, 60.7 years; 437 [54.6%] men) completed the study and were included in the full analysis set', 'intensive care units at 159 sites in 26 countries', 'Patients With Sepsis-Associated Coagulopathy']","['matching placebo', 'human recombinant thrombomodulin vs placebo', 'placebo', 'intravenous bolus or a 15-minute infusion of thrombomodulin', 'Recombinant Human Soluble Thrombomodulin']","['Mortality', 'absolute risk difference', '28-day all-cause mortality', 'cause mortality rate', 'incidence of serious major bleeding adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",816.0,0.638967,"In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P = .32).","[{'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Francois', 'Affiliation': 'ICU Department, Inserm CIC-1435 & UMR-1092, CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Zabolotskikh', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Transfusiology, Kuban State Medical University, Krasnodar, Russia.'}, {'ForeName': 'Mradul Kumar', 'Initials': 'MK', 'LastName': 'Daga', 'Affiliation': 'Department of Medicine, Maulana Azad Medical College and associated hospitals, New Delhi, India.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Mikhail Y', 'Initials': 'MY', 'LastName': 'Kirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Northern State Medical University, Arkhangelsk, Russia.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Faculté de Médecine, Université de Strasbourg (UNISTRA), Hôpitaux Universitaires de Strasbourg, Service de Réanimation, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Mercier', 'Affiliation': 'Médecine Intensive Réanimation, CHRU de Tours, Tours, France.'}, {'ForeName': 'Suzana M', 'Initials': 'SM', 'LastName': 'Lobo', 'Affiliation': 'Intensive Care Division, Hospital de Base, São José do Rio Preto, SP, Brazil.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Barie', 'Affiliation': 'Departments of Surgery and Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Crowther', 'Affiliation': ""Department of Medicine, McMaster University and St Joseph's Hospital, Hamilton, Canada.""}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Esmon', 'Affiliation': 'Coagulation Biology Laboratory, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Pathology and Pharmacology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Gando', 'Affiliation': 'Acute and Critical Care Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Gorelick', 'Affiliation': 'Zymo Consulting Group LLC, Newtown Square, Massachusetts.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': 'Department of Medicine, University College London Hospitals and Cardiometabolic Programme-NIHR UCLH/UCL BRC, London, United Kingdom.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Universite´Paris Descartes, Sorbonne Paris Cite´, Faculte´ de Me´-decine Cochin University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Opal', 'Affiliation': 'Division of Infectious Diseases, Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Parrillo', 'Affiliation': 'Department of Medicine, New Jersey Medical School of Rutgers University, Hackenseck.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Russell', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Tsuruta', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fineberg', 'Affiliation': 'Asahi-Kasei Pharma America Corporation, Waltham, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.5358']
3149,30815861,Promoting Compliance in Children Referred to Child Protective Services: A Randomized Clinical Trial.,"Early experiences of maltreatment have long-term negative effects on children's compliance. This randomized clinical trial examined whether a brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC) was effective in enhancing compliance in children who had been referred to Child Protective Services. Participants included 101 parent-child dyads who received either ABC or a control intervention when children were infants (M = 9.4 months old, SD = 6.1). When children were approximately 36 months old (M = 38.5, SD = 3.0), ABC children demonstrated significantly better compliance than control children. Further, parent sensitivity, measured 1 month post intervention when children were, on average, 18.4 months old (SD = 6.9) partially mediated the effect of ABC on child compliance at 36 months old.",2020,This randomized clinical trial examined whether a brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC) was effective in enhancing compliance in children who had been referred to Child Protective Services.,"['children who had been referred to Child Protective Services', 'Participants included 101 parent-child dyads who received either', 'Children Referred to Child Protective Services']","['brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC', 'ABC or a control intervention']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],101.0,0.0465658,This randomized clinical trial examined whether a brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC) was effective in enhancing compliance in children who had been referred to Child Protective Services.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'University of Maryland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware.'}]",Child development,['10.1111/cdev.13207']
3150,31429794,Efficacy and safety of intravenous golimumab plus methotrexate in patients with rheumatoid arthritis aged < 65 years and those ≥ 65 years of age.,"OBJECTIVE


To evaluate the safety and efficacy of intravenous golimumab + methotrexate (MTX) in patients with active rheumatoid arthritis (RA) aged < 65 years and those ≥ 65 years who were enrolled in the GO-FURTHER study.
METHODS


In the phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, patients with active RA were randomized to intravenous (IV) golimumab 2 mg/kg + MTX or placebo + MTX at weeks 0 and 4, then every 8 weeks thereafter (with crossover to golimumab at week 16 [early escape] or week 24 [per-protocol]). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology (ACR) 20/50/70 response criteria. Efficacy and adverse events (AEs) were monitored through 2 years. Efficacy and AEs were summarized for patients aged < 65 years or ≥ 65 years; AEs were also summarized for patients < or ≥ 70 years and patients < or ≥ 75 years.
RESULTS


In GO-FURTHER, 592 patients were randomized to receive placebo (n = 197) or golimumab (n = 395), 515 were aged < 65 years and 77 were ≥ 65 years. At week 24, ACR20 response rates were greater for golimumab + MTX patients compared with placebo + MTX for patients < 65 years (61.6% vs 31.3%, p < 0.001) and those ≥ 65 years (69.5% vs 33.3%; p < 0.01). Infections were the most common AE through week 112 (51.6% in patients < 65 years; 55.3% in patients ≥ 65 years); upper respiratory infections were the most common infection in patients < 65 years (13.2%) and those ≥ 65 years (11.8%). Serious AEs occurred in 17.7% in patients < 65 years and 25.0% of patients ≥ 65 years and included malignancies, pneumonia, fractures, acute pancreatitis, cellulitis, and bacterial arthritis.
CONCLUSIONS


In GO-FURTHER, ACR response rates were similar between patients < 65 years and patients ≥ 65 years within each treatment group. AEs in elderly patients were similar to the known safety profile of IV golimumab. Immunosenescence is known to increase the risk of infections in the elderly. Elderly patients had a numerically higher incidence of serious infections. Six malignancies occurred in golimumab-treated patients, all in patients < 65 years.
TRIAL REGISTRATION


clinicaltrials.gov: NCT00973479 . Registered September 9, 2009.",2019,"At week 24, ACR20 response rates were greater for golimumab + MTX patients compared with placebo + MTX for patients < 65 years (61.6% vs 31.3%, p < 0.001) and those ≥ 65 years (69.5% vs 33.3%; p < 0.01).","['Elderly patients', '65\u2009years and included malignancies, pneumonia, fractures, acute pancreatitis, cellulitis, and bacterial arthritis', 'patients aged <\u200965\u2009years or ≥\u200965\u2009years; AEs were also summarized for patients < or ≥\u200970\u2009years and patients < or ≥\u200975\u2009years', 'elderly patients', '592 patients', 'American College of Rheumatology (ACR) 20/50/70 response criteria', 'patients with rheumatoid arthritis aged <\u200965\u2009years and those ≥\u200965\u2009years of age', 'patients with active RA', 'patients with active rheumatoid arthritis (RA) aged <\u200965\u2009years and those ≥\u200965\u2009years who were enrolled in the GO-FURTHER study', 'n\u2009=\u2009197) or golimumab (n\u2009=\u2009395), 515 were aged <\u200965\u2009years and 77 were ≥']","['placebo', 'placebo + MTX', 'golimumab + MTX', 'intravenous golimumab + methotrexate (MTX', 'intravenous golimumab plus methotrexate', 'intravenous (IV) golimumab 2\u2009mg/kg + MTX or placebo + MTX']","['ACR response rates', 'Infections', 'Serious AEs', 'respiratory infections', 'Efficacy and safety', 'ACR20 response rates', 'serious infections', 'Efficacy and\xa0adverse\xa0events (AEs', 'Six malignancies', 'safety and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C1692886', 'cui_str': 'Arthritis, Bacterial'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",592.0,0.262572,"At week 24, ACR20 response rates were greater for golimumab + MTX patients compared with placebo + MTX for patients < 65 years (61.6% vs 31.3%, p < 0.001) and those ≥ 65 years (69.5% vs 33.3%; p < 0.01).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tesser', 'Affiliation': 'Arizona Arthritis and Rheumatology Associates, Phoenix, AZ, USA. jtesser1@cox.net.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'DeHoratius', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Rheumatology Associates, Birmingham, AL, USA.'}]",Arthritis research & therapy,['10.1186/s13075-019-1968-x']
3151,30650256,"A Phase 1 Randomized, Placebo-Controlled Trial With a Topical Inhibitor of Stearoyl-Coenzyme A Desaturase 1 Under Occluded and Nonoccluded Conditions.","Stearoyl-coenzyme A desaturase 1 (SCD-1) in sebaceous glands is a key enzyme in the synthesis of monounsaturated fatty acids essential for acne development. GSK1940029 gel, a novel SCD-1 inhibitor, is being developed as a potential treatment for acne. To assess the irritation potential, pharmacokinetics (PK), and safety of topical GSK1940029 to the skin of healthy adults, two interdependent studies were conducted in parallel. Study 1 (n = 54) investigated the irritation potential of GSK1940029 (0.3% and 1%, occluded application) to allow for its application to larger surface areas in study 2 (n = 39), which investigated the safety, tolerability, and PK of GSK1940029 after single and repeat doses as occluded and nonoccluded applications. GSK1940029 was not a primary or cumulative irritant after 2 and 21 days of dosing in study 1. In study 2, single and repeat applications of GSK1940029 (0.1% to 1%) doses were well tolerated with little or no influence on AUC and C max  under occluded or unoccluded conditions. Systemic exposure increased proportionally with surface area and was higher in occluded conditions. Design of these interdependent studies allowed for the assessment of the irritation potential for topical GSK1940029 in parallel with the investigation of PK and safety profiles.",2019,GSK1940029 was not a primary or cumulative irritant after 2 and 21 days of dosing in study 1.,['healthy adults'],"['Stearoyl-coenzyme A desaturase 1 (SCD-1', 'Placebo', 'Topical Inhibitor of Stearoyl-Coenzyme A Desaturase']","['Systemic exposure', 'safety, tolerability', 'irritation potential, pharmacokinetics (PK), and safety', 'AUC and C max  under occluded or unoccluded conditions', 'irritation potential of GSK1940029']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0075202', 'cui_str': 'stearyl-CoA'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0431124,GSK1940029 was not a primary or cumulative irritant after 2 and 21 days of dosing in study 1.,"[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brigandi', 'Affiliation': 'Virtual Proof of Concept Discovery Performance Unit, GlaxoSmithKline, King of Prussia, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, King of Prussia, PA, USA.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Murnane', 'Affiliation': 'Virtual Proof of Concept Discovery Performance Unit, GlaxoSmithKline, King of Prussia, PA, USA.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': 'Reedy', 'Affiliation': 'Virtual Proof of Concept Discovery Performance Unit, GlaxoSmithKline, King of Prussia, PA, USA.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Shakib', 'Affiliation': 'CMAX, a division of IDT Australia Limited, Adelaide, South Australia, Australia.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.644']
3152,31351488,Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study.,"OBJECTIVES


Comparison of two doses of bio-optimized Curcuma longa extract (BCL) in the management of symptomatic knee osteoarthritis (OA).
METHODS


A prospective, randomized, 3-month, double-blind, multicenter, three-group, placebo-controlled trial assessing Patient Global Assessment of Disease Activity (PGADA) and serum sColl2-1, a biomarker of cartilage degradation, as co-primary endpoints. Pain on visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), and paracetamol/non-steroidal anti-inflammatory drug (NSAID) consumption were used as secondary endpoints.
RESULTS


One hundred fifty patients with knee OA were followed for 90 days. Low and high doses of BCL showed a greater decrease of PGADA than placebo. Analysis of sColl2-1 showed in the placebo and BCL low-dose groups, but not in the BCL high-dose group, a transient but non-significant increase of sColl2-1 between T0 and T1. Thereafter, in all groups, sColl2-1 decreased between T1 and T3 (all p < 0.01), but no difference between the groups was found. Pain reduction at day 90 in the low- and high-dose BCL groups (- 29.5 mm and - 36.5 mm) was higher than that in the placebo (- 8 mm; p = 0.018). The global KOOS significantly decreased overtime, but changes were comparable across treatment arms. The ratio of patients with adverse events (AE) related to the product was similar in the placebo and treatment groups, but the number of AE linked to the product was higher in the high-dose BCL group compared to the placebo (p = 0.012).
CONCLUSIONS


BCL appeared safe and well-tolerated with no evidence of severe adverse effects. Efficacy analysis suggested positive trends for measurements of PGADA and serum levels of an OA biomarker and showed a rapid and significant decrease of pain in knee OA (Trial registration: ISRCTN, ISRCTN12345678. Registered 21 September 2016-retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02909621?term=osteoarthritis+curcumin&rank=5-Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA) NCT02909621).",2019,"The ratio of patients with adverse events (AE) related to the product was similar in the placebo and treatment groups, but the number of AE linked to the product was higher in the high-dose BCL group compared to the placebo (p = 0.012).
","['knee osteoarthritis pain', 'One hundred fifty patients with knee OA', 'symptomatic knee osteoarthritis (OA']","['bio-optimized Curcuma longa extract (BCL', 'BCL', 'placebo', 'Bio-optimized Curcuma longa extract']","['safe and well-tolerated', 'number of AE linked to the product', 'PGADA', 'pain', 'Pain on visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), and paracetamol/non-steroidal anti-inflammatory drug (NSAID) consumption', 'Patient Global Assessment of Disease Activity (PGADA) and serum sColl2-1, a biomarker of cartilage degradation', 'Pain reduction']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C3540735', 'cui_str': 'Curcuma longa whole extract'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",150.0,0.520136,"The ratio of patients with adverse events (AE) related to the product was similar in the placebo and treatment groups, but the number of AE linked to the product was higher in the high-dose BCL group compared to the placebo (p = 0.012).
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Henrotin', 'Affiliation': 'Bone and Cartilage Research Unit, Arthropôle Liège, Institute of Pathology, Level 5, CHU Sart-Tilman, University of Liège, 4000, Liège, Belgium. yhenrotin@uliege.be.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malaise', 'Affiliation': 'Rheumatology Department, CHU Sart-Tilman, Liège, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wittoek', 'Affiliation': 'Rheumatology Department, UZ Gent, Ghent, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Rheumatology Department, ZNA Jan Palfijn, Merksem, Belgium.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Brasseur', 'Affiliation': 'Rheumatology Department, CHU UCL Namur, Yvoir, Belgium.'}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Luyten', 'Affiliation': 'Rheumatology Department, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Jiangang', 'Affiliation': 'Rheumatology and Physical Medicine Department, Hôpitaux Iris Sud, Bruxelles, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van den Berghe', 'Affiliation': 'Rheumatology Department, Algemeen Stedelijk Ziekenhuis, Aalst, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Uhoda', 'Affiliation': ""Physical Medicine and Rehabilitation Department, Centre Hospitalier du Bois de l'Abbaye, Seraing, Belgium.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bentin', 'Affiliation': 'Rheumatology Department, CHU Brugmann, Bruxelles, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'De Vroey', 'Affiliation': 'Physical Medicine, UZA, Antwerpen, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Erpicum', 'Affiliation': ', Anthisnes, Belgium.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Donneau', 'Affiliation': 'Public health Science Department, University of Liège, Liège, Belgium.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Dierckxsens', 'Affiliation': 'Tilman SA, Baillonville, Belgium.'}]",Arthritis research & therapy,['10.1186/s13075-019-1960-5']
3153,31116392,The translation of an evidence-based preschool physical activity intervention from in-person to online delivery of professional development to preschool teachers.,"Study of Health and Activity in Preschool Environments (SHAPES) aimed to increase preschoolers' physical activity by engaging preschool teachers in professional development designed to modify instructional practices. SHAPES originated as a randomized controlled trial, tested in 16 preschools and disseminated to 4 control schools, and was shown to be effective in increasing preschool children's physical activity (Phase I, 2008-2012). This article describes the steps taken to translate an evidence-based physical activity intervention, SHAPES, from in-person delivery to online delivery of professional development to preschool teachers. In Phase II (2013-2016), professional development delivery was modified from an in-person to an online program for preschool teachers. Teacher implementation completeness and fidelity were examined in 10 pilot preschools and then replicated in 30 preschools. Large-scale dissemination of SHAPES began in Phase III (2017-2019), reaching 818 teachers from 228 unique centers after 2 years. The final SHAPES program consisted of six online modules, an accompanying guidebook, over 90 activities, self-assessment techniques, a video library, and an electronic community forum. The SHAPES core elements, defined in Phase I, were retained throughout all three phases. The Phase II change to online delivery was characterized by high levels of implementation completeness and fidelity. Results of Phase III statewide dissemination revealed comparable implementation completeness and fidelity. An intervention shown to be effective in a randomized controlled trial can be translated into an online professional development program and disseminated on a large scale in a timely manner.",2019,An intervention shown to be effective in a randomized controlled trial can be translated into an online professional development program and disseminated on a large scale in a timely manner.,"['10 pilot preschools and then replicated in 30 preschools', ""preschool children's physical activity (Phase I, 2008-2012"", 'preschool teachers', '16 preschools and disseminated to 4 control schools']","['preschool physical activity intervention', 'professional development delivery was modified from an in-person to an online program']",['implementation completeness and fidelity'],"[{'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0205221', 'cui_str': 'Disseminated (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}]",,0.0223651,An intervention shown to be effective in a randomized controlled trial can be translated into an online professional development program and disseminated on a large scale in a timely manner.,"[{'ForeName': 'Ruth P', 'Initials': 'RP', 'LastName': 'Saunders', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Public Health Research Center, University of South Carolina, Suite, Columbia, SC, USA.'}, {'ForeName': 'Michaela A', 'Initials': 'MA', 'LastName': 'Schenkelberg', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Maurer Center for Public Health, Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Moyer', 'Affiliation': 'Department of Exercise Science, Public Health Research Center, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Howie', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Brown', 'Affiliation': 'Educational Studies, Wardlaw College, University of South Carolina, Columbia, USA.'}, {'ForeName': 'Russell R', 'Initials': 'RR', 'LastName': 'Pate', 'Affiliation': 'Department of Exercise Science, Public Health Research Center, University of South Carolina, Columbia, SC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz076']
3154,30544179,Using a holistic health approach to achieve weight-loss maintenance: results from the Spirited Life intervention.,"Weight-loss maintenance is essential to sustain the health benefits of weight loss. Studies with lower intensity intervention supports under real-world conditions are lacking. This study examined changes in weight and cardiometabolic biomarkers among Spirited Life participants following initial 12-month weight loss at 12-24 months and 24-42 months. A total of 719 clergy received a wellness intervention, including a 10-week online weight-loss program in the first 12 months and monthly health coaching throughout 24 months. Mean changes in weight, blood pressure, high-density lipoproteins, and triglycerides were estimated using random effects linear models, accounting for repeated measures. Weight was additionally analyzed in subsamples stratified by body mass index (BMI). At baseline, 17.1% of participants had BMI < 25 kg/m2 and 11.8% had BMI ≥ 40 kg/m2. Mean 12-month weight loss was -2.4 kg (95% CI: -2.8 kg, -2.1 kg). On average, at 42 months, participants regained weight but did not exceed baseline (-0.5 kg, 95% CI: -1.2 kg, 0.2 kg), improvements in triglycerides were completely sustained (-13.9 mg/dL, 95% CI: -18.6 mg/dL, -9.2 mg/dL), and systolic blood pressure improvements remained significant (-1.9 mmHg, 95% CI: -3.0 mmHg, -0.9 mmHg). Participants with a BMI ≥ 40 kg/m2 lost significantly more weight that was sustained at 42 months (-5.8 kg, 95% CI: -8.9 kg, -2.7 kg). The Spirited Life wellness intervention produced weight loss and, for participants with higher levels of obesity, sustained weight-loss maintenance. The intervention was effective for long-term prevention of weight gain among participants with BMI of 25 to ≤40 kg/m2, through 42 months. Wellness interventions such as Spirited Life should be considered for adoption.",2020,The intervention was effective for long-term prevention of weight gain among participants with BMI of 25,"['A total of 719 clergy received a', 'participants with BMI of 25', 'Spirited Life participants following initial 12-month weight loss at 12-24 months and 24-42 months']","['wellness intervention, including a 10-week online weight-loss program in the first 12 months and monthly health coaching throughout 24 months', 'holistic health approach']","['Mean 12-month weight loss', 'Mean changes in weight, blood pressure, high-density lipoproteins, and triglycerides', 'improvements in triglycerides', 'weight loss', 'weight-loss maintenance', 'obesity, sustained weight-loss maintenance', 'Weight', 'weight and cardiometabolic biomarkers', 'systolic blood pressure improvements', 'weight gain', 'weight']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008935', 'cui_str': 'Clergy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0019844', 'cui_str': 'Wholistic Health Care'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",719.0,0.0427098,The intervention was effective for long-term prevention of weight gain among participants with BMI of 25,"[{'ForeName': 'Rae Jean', 'Initials': 'RJ', 'LastName': 'Proeschold-Bell', 'Affiliation': 'Duke Global Health Institute, Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Dori M', 'Initials': 'DM', 'LastName': 'Steinberg', 'Affiliation': 'Duke School of Nursing, Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Eagle', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Grace Y', 'Initials': 'GY', 'LastName': 'Cai', 'Affiliation': 'Trinity College of Arts & Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby117']
3155,30609409,Interpretation of Genomic Sequencing Results in Healthy and Ill Newborns: Results from the BabySeq Project.,"Genomic sequencing provides many opportunities in newborn clinical care, but the challenges of interpreting and reporting newborn genomic sequencing (nGS) results need to be addressed for its broader and effective application. The BabySeq Project is a pilot randomized clinical trial that explores the medical, behavioral, and economic impacts of nGS in well newborns and those admitted to a neonatal intensive care unit (NICU). Here we present childhood-onset and actionable adult-onset disease risk, carrier status, and pharmacogenomics findings from nGS of 159 newborns in the BabySeq Project. nGS revealed a risk of childhood-onset disease in 15/159 (9.4%) newborns; none of the disease risks were anticipated based on the infants' known clinical or family histories. nGS also revealed actionable adult-onset disease risk in 3/85 (3.5%) newborns whose parents consented to receive this information. Carrier status for recessive diseases and pharmacogenomics variants were reported in 88% and 5% of newborns, respectively. Additional indication-based analyses were performed in 29/32 (91%) NICU newborns and 6/127 (5%) healthy newborns who later had presentations that prompted a diagnostic analysis. No variants that sufficiently explained the reason for the indications were identified; however, suspicious but uncertain results were reported in five newborns. Testing parental samples contributed to the interpretation and reporting of results in 13/159 (8%) newborns. Our results suggest that nGS can effectively detect risk and carrier status for a wide range of disorders that are not detectable by current newborn screening assays or predicted based on the infant's known clinical or family history, and the interpretation of results can substantially benefit from parental testing.",2019,"Our results suggest that nGS can effectively detect risk and carrier status for a wide range of disorders that are not detectable by current newborn screening assays or predicted based on the infant's known clinical or family history, and the interpretation of results can substantially benefit from parental testing.","['159 newborns in the BabySeq Project', 'Healthy and Ill Newborns', 'NICU newborns and 6/127', 'well newborns and those admitted to a neonatal intensive care unit (NICU']",['nGS'],['risk of childhood-onset disease'],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0229189,"Our results suggest that nGS can effectively detect risk and carrier status for a wide range of disorders that are not detectable by current newborn screening assays or predicted based on the infant's known clinical or family history, and the interpretation of results can substantially benefit from parental testing.","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Ceyhan-Birsoy', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA; Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine, Cambridge, MA 02139, USA.'}, {'ForeName': 'Jaclyn B', 'Initials': 'JB', 'LastName': 'Murry', 'Affiliation': 'Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine, Cambridge, MA 02139, USA; Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Kalotina', 'Initials': 'K', 'LastName': 'Machini', 'Affiliation': 'Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine, Cambridge, MA 02139, USA; Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Lebo', 'Affiliation': ""Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine, Cambridge, MA 02139, USA; Department of Pathology, Brigham and Women's Hospital, Boston, MA 02115, USA; Harvard Medical School, Boston, MA 02115, USA; The Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA.""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Yu', 'Affiliation': ""Harvard Medical School, Boston, MA 02115, USA; Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA 02115, USA; Department of Neurology, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Fayer', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Casie A', 'Initials': 'CA', 'LastName': 'Genetti', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Talia S', 'Initials': 'TS', 'LastName': 'Schwartz', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Pankaj B', 'Initials': 'PB', 'LastName': 'Agrawal', 'Affiliation': ""Harvard Medical School, Boston, MA 02115, USA; Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA 02115, USA; Division of Newborn Medicine, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Parad', 'Affiliation': ""Harvard Medical School, Boston, MA 02115, USA; Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Holm', 'Affiliation': ""Harvard Medical School, Boston, MA 02115, USA; Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'McGuire', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': ""Harvard Medical School, Boston, MA 02115, USA; Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA; The Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA.""}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Rehm', 'Affiliation': ""Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine, Cambridge, MA 02139, USA; Department of Pathology, Brigham and Women's Hospital, Boston, MA 02115, USA; Harvard Medical School, Boston, MA 02115, USA; The Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA; Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA 02114, USA.""}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Beggs', 'Affiliation': ""Harvard Medical School, Boston, MA 02115, USA; Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, MA 02115, USA. Electronic address: beggs@enders.tch.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of human genetics,['10.1016/j.ajhg.2018.11.016']
3156,31361726,Postoperative Blood Salvage and Autotransfusion for Adult Spinal Deformity: A Randomized Controlled Trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


The aim of this study was to determine whether postoperative blood salvage and autotransfusion versus traditional closed suction drainage reduces the rate of homologous blood transfusions in patients undergoing surgery for adult spinal deformity.
SUMMARY OF BACKGROUND DATA


The use of intraoperative blood salvage has become commonplace in spine surgery; however, the collection and reinfusion of blood drained from the wound postoperatively have not been employed routinely because of increased cost and questionable benefit.
METHODS


Adult patients undergoing long posterior fusions were randomized to either a blood salvage and reinfusion system (OrthoPat - Group 1) or a standard subfascial closed suction drain (Group 2). Blood collected in Group 1 was reinfused according to the manufacturer's protocol. Reinfusion drains were converted to standard closed suction drains when output was <50 mL during 4 hours, and drains were removed when output was minimal. Patients received autologous or homologous blood transfusions when hemoglobin (Hg) <8 g/dL or they had symptomatic anemia.
RESULTS


Thirty-four patients were randomized into Group 1 and 36 patients into Group 2. There were no differences in preoperative or intraoperative parameters. Patients in Group 1 had higher hemoglobin levels on postoperative day (POD) 2 and POD 3 compared to those in Group 2. However, there was no significant difference in the percentage of patients requiring homologous blood transfusion between the two groups (41% Group 1 vs. 60% Group 2, P = 0.17). Similarly a subgroup analysis in patients with estimated blood loss >2000 mL also showed no difference in homologous blood transfusion rates (67% Group 1 vs. 76% Group 2, P = 0.58). There were no differences in the rate or type of postoperative complications.
CONCLUSION


Postoperative blood salvage and reinfusion result in a higher hemoglobin level in the early postoperative period, but does not significantly reduce the need for homologous blood transfusion.
LEVEL OF EVIDENCE


1.",2020,"There were no differences in the rate or type of post-operative complications.
","['patients undergoing surgery for adult spinal deformity', 'Adult Spinal Deformity', '34 patients', 'Adult patients undergoing long posterior fusions']","['blood salvage and reinfusion system (OrthoPat - Group 1) or a standard subfascial closed suction drain', 'Post-Operative Blood Salvage and Autotransfusion', 'post-operative blood salvage and autotransfusion vs. traditional closed suction drainage', 'intra-operative blood salvage', 'autologous or homologous blood transfusions']","['homologous blood transfusion rates', 'pre-operative or intra-operative parameters', 'hemoglobin levels', 'hemoglobin level', 'rate of homologous blood transfusions', 'rate or type of post-operative complications', 'percentage of patients requiring homologous blood transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0005768'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0580529', 'cui_str': 'Subfascial (qualifier value)'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C2936225', 'cui_str': 'Post-Operative Blood Salvage'}, {'cui': 'C0005842', 'cui_str': 'Autotransfusion'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2936794', 'cui_str': 'Operative Blood Salvage'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]","[{'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",34.0,0.110178,"There were no differences in the rate or type of post-operative complications.
","[{'ForeName': 'Venu M', 'Initials': 'VM', 'LastName': 'Nemani', 'Affiliation': 'Raleigh Orthopaedic Clinic, Raleigh, NC.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Spine and Scoliosis Service, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Curtis A', 'Initials': 'CA', 'LastName': 'Mina', 'Affiliation': 'OrthoArizona, Scottsdale, AZ.'}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Sheha', 'Affiliation': 'Spine and Scoliosis Service, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ross', 'Affiliation': 'Spine and Scoliosis Service, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Oheneba', 'Initials': 'O', 'LastName': 'Boachie-Adjei', 'Affiliation': 'FOCOS Hospital, Kanda, Accra, Ghana.'}]",Spine,['10.1097/BRS.0000000000003176']
3157,30370956,A randomized trial of three novel regimens for recurrent acute myeloid leukemia demonstrates the continuing challenge of treating this difficult disease.,"To improve the outcome of relapsed/refractory acute myeloid leukemia (AML), a randomized phase II trial of three novel regimens was conducted. Ninety patients were enrolled and were in first relapse or were refractory to induction/re-induction chemotherapy. They were randomized to the following regimens: carboplatin-topotecan (CT), each by continuous infusion for 5 days; alvocidib (formerly flavopiridol), cytarabine, and mitoxantrone (FLAM) in a timed sequential regimen; or sirolimus combined with mitoxantrone, etoposide, and cytarabine (S-MEC). The primary objective was attainment of a complete remission (CR). A Simon two-stage design was used for each of the three arms. The median age of the patients in the FLAM arm was older at 62 years compared with 55 years for the CT arm and the S-MEC arm. The overall response was 14% in the CT arm (5/35, 90% CI 7%-35%), 28% in the FLAM arm (10/36, 90% CI, 16%-43%), and 16% in the S-MEC arm (3/19, 90% CI, 4%-36%). There were nine treatment-related deaths, seven of which occurred in the FLAM arm with four of these in elderly patients. We conclude that the FLAM regimen had an encouraging response rate and should be considered for further clinical development but should be used with caution in elderly patients.",2019,"The overall response was 14% in the CT arm (5/35, 90% CI 7%-35%), 28% in the FLAM arm (10/36, 90% CI, 16%-43%), and 16% in the S-MEC arm (3/19, 90% CI, 4%-36%).","['Ninety patients were enrolled and were in first relapse or were refractory to induction/re-induction chemotherapy', 'relapsed/refractory acute myeloid leukemia (AML', 'elderly patients', 'recurrent acute myeloid leukemia']","['carboplatin-topotecan (CT', 'FLAM', 'sirolimus combined with mitoxantrone, etoposide, and cytarabine (S-MEC', 'alvocidib (formerly flavopiridol), cytarabine, and mitoxantrone (FLAM']","['attainment of a complete remission (CR', 'overall response']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute (qualifier value)'}, {'cui': 'C0023470', 'cui_str': 'Myelogenous Leukemia'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0281603', 'cui_str': 'alvocidib'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",90.0,0.0482751,"The overall response was 14% in the CT arm (5/35, 90% CI 7%-35%), 28% in the FLAM arm (10/36, 90% CI, 16%-43%), and 16% in the S-MEC arm (3/19, 90% CI, 4%-36%).","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Litzow', 'Affiliation': 'Departments of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xin V', 'Initials': 'XV', 'LastName': 'Wang', 'Affiliation': 'Biostatistics and Computational Biology, Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Carroll', 'Affiliation': 'Oncology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Karp', 'Affiliation': 'Hematology/Medical Oncology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rhett P', 'Initials': 'RP', 'LastName': 'Ketterling', 'Affiliation': 'Departments of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Departments of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kaufmann', 'Affiliation': 'Departments of Oncology Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Hillard M', 'Initials': 'HM', 'LastName': 'Lazarus', 'Affiliation': 'Seidman Cancer Center, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Selina M', 'Initials': 'SM', 'LastName': 'Luger', 'Affiliation': 'Oncology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Paietta', 'Affiliation': 'Oncology, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Pratz', 'Affiliation': 'Hematology/Medical Oncology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Han Win', 'Initials': 'HW', 'LastName': 'Tun', 'Affiliation': 'Hematology/Oncology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Altman', 'Affiliation': 'Hematology/Medical Oncology, Northwestern University School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Broun', 'Affiliation': 'Hematology/Oncology, Oncology Hematology Care, Inc, Jewish Hospital, Cincinnati, Ohio.'}, {'ForeName': 'Witold B', 'Initials': 'WB', 'LastName': 'Rybka', 'Affiliation': 'Medicine and Pathology, Penn State Hershey Cancer Institute, Hershey, Pennsylvania.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Rowe', 'Affiliation': 'Department of Hematology, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Hematology/Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",American journal of hematology,['10.1002/ajh.25333']
3158,30496510,"Pulsed Ultrasounds Reduce Pain and Disability, Increasing Rib Fracture Healing, in a Randomized Controlled Trial.","INTRODUCTION


Rib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists.
OBJECTIVES


Based on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans.
METHODS


Prospective, double-blinded, randomized, controlled trial of 51 patients. Four were excluded, and 47 were randomized into the control group (N = 23) or PUS group (N = 24). The control group received a PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm2 for 1 min/cm2. Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events were blindly evaluated at baseline and one, three, and six months.
RESULTS


There were no significant differences at baseline between groups. PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017). No related adverse events were found in the PUS group.
CONCLUSIONS


This study is the first evidence that PUS treatment is capable of improving rib fracture outcome, significantly accelerating bone callus healing, and decreasing pain, time off due to both physical activity and convalescence period, and pain medication intake. It is a safe, efficient, and low-cost therapy that may become a new treatment for patients with stable rib fractures.",2019,"PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017).","['patients with stable rib fractures', '51 patients']","['PUS', 'Pulsed Ultrasounds', 'pulsed ultrasound (PUS) application', 'PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm2 for 1\u2009min/cm2']","['pain', 'accelerated callus healing', 'rib fracture outcome', 'adverse events', 'work activity', 'Pain and Disability', 'Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events', 'accelerated return to physical activity', 'pain medication intake']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C2143225', 'cui_str': 'Pulsed Ultrasound'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0233929', 'cui_str': 'Emission (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0556964', 'cui_str': 'watt/centimeter squared'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439479', 'cui_str': 'square centimeters'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376154', 'cui_str': 'Callosities'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",51.0,0.0419113,"PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017).","[{'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Santana-Rodríguez', 'Affiliation': 'Section of Thoracic Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Bernardino', 'Initials': 'B', 'LastName': 'Clavo', 'Affiliation': 'Instituto Universitario de Investigaciones Biomédicas y Sanitarias IUIBS-BioPharm Group, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Llontop', 'Affiliation': 'Instituto Universitario de Investigaciones Biomédicas y Sanitarias IUIBS-BioPharm Group, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'María D', 'Initials': 'MD', 'LastName': 'Fiuza', 'Affiliation': 'Instituto Universitario de Investigaciones Biomédicas y Sanitarias IUIBS-BioPharm Group, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud-Gastardi', 'Affiliation': 'Department of Thoracic Surgery, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López', 'Affiliation': 'Experimental Surgery Group, Research Unit, Hospital Dr. Negrín, Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-Fernández', 'Affiliation': 'Instituto Universitario de Investigaciones Biomédicas y Sanitarias IUIBS-BioPharm Group, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ione A', 'Initials': 'IA', 'LastName': 'Aguiar-Santana', 'Affiliation': 'Instituto Universitario de Investigaciones Biomédicas y Sanitarias IUIBS-BioPharm Group, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Ayub', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch Galveston, Galveston, Texas, USA.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Alshehri', 'Affiliation': 'Section of Thoracic Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Nagib A', 'Initials': 'NA', 'LastName': 'Jordi', 'Affiliation': 'Department of Orthopedic Surgery and Upper Extremity Unit, Healthpoint Hospital, Abu Dhabi, UAE.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Zubeldia', 'Affiliation': 'Experimental Surgery Group, Research Unit, Hospital Dr. Negrín, Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Dieter C', 'Initials': 'DC', 'LastName': 'Bröering', 'Affiliation': 'Section of Thoracic Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny224']
3159,30406840,Exposure-response relationship of olaratumab for survival outcomes and safety when combined with doxorubicin in patients with soft tissue sarcoma.,"PURPOSE


Olaratumab is a recombinant human IgG1 monoclonal antibody against PGDFRα. Olaratumab plus doxorubicin improved survivalversus doxorubicin in an open-label, randomised phase 2 soft tissue sarcoma (STS) trial. We characterised the olaratumab exposure-response relationship for progression-free survival (PFS), overall survival (OS), and safety.
METHODS


PFS and OS data from the 133 patients enrolled in the phase 2 study were analysed using time-to-event modelling. The effect of olaratumab on PFS/OS was explored using the trough serum concentration after cycle 1 (C min1 ) and the average concentration throughout treatment (C avg ). The rate of treatment-emergent adverse events (TEAEs) was compared across olaratumab exposure quartiles.
RESULTS


PFS and OS were described by models with an exponential hazard function and inhibitory E MAX  functions to describe the effect of olaratumab, regardless of the PK endpoint. The olaratumab EC50s for PFS (EC min1 50 = 82.0 µg/mL, EC avg 50 = 179 µg/mL) and OS (EC min1 50 = 66.1 µg/mL, EC avg 50 = 134 µg/mL) corresponded to the median and 25th percentile of C min1 /C avg  in the study, respectively. Maximum predicted improvement in the hazard ratio for OS and PFS was approximately 75% and 60%, respectively. There was no change in the rate of TEAEs with increasing olaratumab serum levels.
CONCLUSIONS


PFS/OS benefits occurred without a rate change in TEAEs across quartiles. Maximum benefit in OS was achieved in the upper three quartiles and a potential of early disease progression in the lower quartile of olaratumab serum exposure. These results prompted a loading dose strategy in the ongoing phase 3 STS trial.",2019,Maximum benefit in OS was achieved in the upper three quartiles and a potential of early disease progression in the lower quartile of olaratumab serum exposure.,"['patients with soft tissue sarcoma', '133 patients enrolled in the phase 2 study were analysed using time-to-event modelling', 'avg 50\u2009']","['doxorubicin', 'EC']","['OS benefits', 'rate of treatment-emergent adverse events (TEAEs', 'rate of TEAEs', 'hazard ratio for OS and PFS', 'progression-free survival (PFS), overall survival (OS), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",133.0,0.0895934,Maximum benefit in OS was achieved in the upper three quartiles and a potential of early disease progression in the lower quartile of olaratumab serum exposure.,"[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, 98109, USA. robin.Jones@rmh.nhs.uk.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Mo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Baldwin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Peterson', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ilaria', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Conti', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.'}, {'ForeName': 'Damien M', 'Initials': 'DM', 'LastName': 'Cronier', 'Affiliation': 'Eli Lilly and Company, Lilly Research Centre, Erl Wood Manor Sunninghill Road, Windlesham, Surrey, GU20 6PH, UK.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 1275 York Ave, New York, NY, 10065, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-018-3723-4']
3160,31045229,"The Impact of Surgical Amputation and Valproic Acid on Pain and Functional Trajectory: Results from the Veterans Integrated Pain Evaluation Research (VIPER) Randomized, Double-Blinded Placebo-Controlled Trial.","OBJECTIVE


To determine if the perioperative administration of valproic acid reduces the incidence of chronic pain three months after amputation or revision surgery.
DESIGN


Multicenter, randomized, double-blind, placebo-controlled trial.
SETTING


Academic, military, and veteran medical centers.
SUBJECTS


One hundred twenty-eight patients undergoing amputation or amputation revision surgery at Duke University Hospital, Walter Reed National Military Medical Center, or the Durham Veterans Affairs Medical Center for either medical disease or trauma.
METHODS


Patients were randomized to placebo or valproic acid for the duration of hospitalization and treated with multimodal analgesic care, including regional anesthetic blockade. Primary outcome was the proportion of patients with chronic pain at three months (average numeric pain score intensity of 3/10 or greater). Secondary outcomes included functional trajectories (assessed with the Brief Pain Inventory short form and the Defense and Veterans Pain Rating Scale).
RESULTS


The overall rate of chronic pain was 68.2% in the 107 patients who completed the end point assessment. There was no significant effect of perioperative valproic acid administration, with a rate of 65.45% (N = 36) in the treatment group and a rate of 71.15% (N = 37) in the placebo group. Overall, pain scores decreased from baseline to follow-up (median = -2 on the numeric pain scale). Patients additionally experienced improvements in self-perceived function.
CONCLUSIONS


The rate of chronic pain after amputation surgery is not significantly improved with the perioperative administration of valproic acid. In this cohort treated with multimodal perioperative analgesia and regional anesthetic blockade, we observed improvements in both pain severity and function.",2019,"There was no significant effect of perioperative valproic acid administration, with a rate of 65.45% (N = 36) in the treatment group and a rate of 71.15% (N = 37) in the placebo group.","['One hundred twenty-eight patients undergoing amputation or amputation revision surgery at Duke University Hospital, Walter Reed National Military Medical Center, or the Durham Veterans Affairs Medical Center for either medical disease or trauma', 'chronic pain three months after amputation or revision surgery', 'Patients', 'Academic, military, and veteran medical centers']","['placebo', 'Placebo', 'Surgical Amputation and Valproic Acid', 'valproic acid', 'placebo or valproic acid', 'multimodal analgesic care, including regional anesthetic blockade']","['pain severity and function', 'proportion of patients with chronic pain', 'perioperative valproic acid administration', 'Overall, pain scores', 'rate of chronic pain', 'overall rate of chronic pain', 'self-perceived function', 'functional trajectories (assessed with the Brief Pain Inventory short form and the Defense and Veterans Pain Rating Scale', 'Pain and Functional Trajectory']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0185432', 'cui_str': 'Amputation stump procedure (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454851', 'cui_str': 'Durham (geographic location)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0042291', 'cui_str': 'Valproic Acid'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0042291', 'cui_str': 'Valproic Acid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0222045'}]",128.0,0.712473,"There was no significant effect of perioperative valproic acid administration, with a rate of 65.45% (N = 36) in the treatment group and a rate of 71.15% (N = 37) in the placebo group.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Buchheit', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Hung-Lun John', 'Initials': 'HJ', 'LastName': 'Hsia', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cooter', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Shortell', 'Affiliation': 'Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kent', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McDuffie', 'Affiliation': 'Walter Reed National Military Medical Center, Defense and Veterans Center for Integrative Pain Management, Rockville, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shaw', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Chester Trip', 'Initials': 'CT', 'LastName': 'Buckenmaier', 'Affiliation': 'Department of Military Emergency Medicine, Defense and Veterans Center for Integrative Pain Management, Uniformed Services University, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Van de Ven', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham VA Medical Center, Durham, North Carolina.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz067']
3161,32061431,Effects of maxillomandibular fixation and rigid internal fixation on pulmonary function in patients with mandibular fractures.,"Closed reduction and maxillomandibular fixation (MMF) is associated with airway obstruction. The ventilatory effect of open reduction and rigid internal fixation (ORIF) as an alternative treatment has not been determined. The aim of this study was to compare the effects of MMF and ORIF on pulmonary function (PF) in patients with mandibular fractures. Using a computer-generated simple randomization protocol, 40 eligible participants were allocated to MMF and ORIF treatment groups. PF tests were done preoperatively and at 24hours, 1, 6, and 7 weeks postoperative in all participants in both groups, using a portable office spirometer (Spirobank G). Forced vital capacity (FVC), forced expiratory volume in one second (FEV 1 ), FEV 1 /FVC, and peak expiratory flow rate (PEFR) were determined. At 6 weeks postoperative, PF tests were performed after the release of MMF. PF tests in the MMF and ORIF groups were similar preoperatively. At 24hours postoperative, FEV 1 /FVC was significantly lower in the MMF group than in the ORIF group (p<0.001). Values of FEV 1  (p=0.022), FEV 1 /FVC (p=0.001) and PEFR (p<0.001) were significantly lower in the MMF group than in the ORIF group at 1 week postoperative. While MMF negatively impacted on PF, ORIF had no adverse effect on PF.",2020,"At 24hours postoperative, FEV 1 /FVC was significantly lower in the MMF group than in the ORIF group (p<0.001).","['patients with mandibular fractures', '40 eligible participants']","['maxillomandibular fixation and rigid internal fixation', 'Closed reduction and maxillomandibular fixation (MMF', 'MMF', 'rigid internal fixation (ORIF', 'MMF and ORIF']","['pulmonary function (PF', 'pulmonary function', 'PEFR', 'PF tests', 'Forced vital capacity (FVC), forced expiratory volume in one second (FEV 1 ), FEV 1 /FVC, and peak expiratory flow rate (PEFR', 'FEV 1 /FVC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}]","[{'cui': 'C0376509', 'cui_str': 'Maxillomandibular Fixation'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}]",40.0,0.0422404,"At 24hours postoperative, FEV 1 /FVC was significantly lower in the MMF group than in the ORIF group (p<0.001).","[{'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Famurewa', 'Affiliation': 'Department of Oral/Maxillofacial Surgery and Oral Pathology, Faculty of Dentistry, Obafemi Awolowo University, Ile-Ife, Nigeria. Electronic address: murewadele83@gmail.com.'}, {'ForeName': 'F O', 'Initials': 'FO', 'LastName': 'Oginni', 'Affiliation': 'Department of Oral/Maxillofacial Surgery and Oral Pathology, Faculty of Dentistry, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Aregbesola', 'Affiliation': 'Department of Oral/Maxillofacial Surgery and Oral Pathology, Faculty of Dentistry, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Erhabor', 'Affiliation': 'Department of Medicine, Faculty of Clinical Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.01.027']
3162,31204873,A randomised trial comparing two protocols for transrectal prostate repeat biopsy: six lateral posterior plus six anterior cores versus a standard posterior 12-core biopsy.,"Objective:  To test the hypothesis that a combination of 6 posterior and 6 anterior cores detects more cancer than 12 posterior cores at a repeat transrectal prostate biopsy in men who have had one previous benign systematic biopsy. Patients and methods:  Three hundred and forty men with persistently raised serum PSA were randomly allocated 1:1 to either a standard 12-core biopsy (12 cores from the lateral peripheral zone through a side-fire biopsy canal) or an experimental 12-core biopsy protocol with 6 anterior cores through an end-fire biopsy canal and 6 cores from the lateral peripheral zone through a side-fire biopsy canal. All biopsies were obtained transrectally with ultrasound guidance. The primary endpoint was cancer detection. Secondary endpoints were detection of ISUP Grade Groups/Gleason Grade Group ≥2 cancer, total biopsy cancer length and complications leading to medical intervention. Results:  Prostate cancer was detected in 42/168 men (25%) in the experimental biopsy group and in 36/172 (21%) in the standard biopsy group ( p  = 0.44). The corresponding proportions for Gleason score ≥7 were 12% and 7% ( p  = 0.14). Median total cancer length was 4 (inter quartile range [IQR] = 1.5 - 6) mm in the end-fire group and 3 (IQR = 1.3 - 7) mm in the side-fire group. Ten men in the end-fire group and three in the side-fire group had a medical intervention for biopsy-related complications ( p  = 0.05). Conclusion:  The biopsy protocol that included six end-fire anterior cores did not detect more cancer and was associated with more complications. Trial registration:  ClinicalTrials.gov identifier: NCT02761135.",2019,The corresponding proportions for Gleason score ≥7 were 12% and 7% ( p  = 0.14).,"['men who have had one previous benign systematic biopsy', 'Three hundred and forty men with persistently raised serum PSA']","['standard 12-core biopsy (12 cores from the lateral peripheral zone through a side-fire biopsy canal) or an experimental 12-core biopsy protocol with 6 anterior cores through an end-fire biopsy canal and 6 cores from the lateral peripheral zone through a side-fire biopsy canal', 'transrectal prostate repeat biopsy: six lateral posterior plus six anterior cores versus a standard posterior 12-core biopsy']","['detection of ISUP Grade Groups/Gleason Grade Group ≥2 cancer, total biopsy cancer length and complications leading to medical intervention', 'cancer detection', 'Median total cancer length', 'medical intervention for biopsy-related complications', 'Prostate cancer']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",340.0,0.0885269,The corresponding proportions for Gleason score ≥7 were 12% and 7% ( p  = 0.14).,"[{'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Örtegren', 'Affiliation': 'Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden.'}, {'ForeName': 'Jan Tage', 'Initials': 'JT', 'LastName': 'Holmberg', 'Affiliation': 'Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Lekås', 'Affiliation': 'Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden.'}, {'ForeName': 'Sabah', 'Initials': 'S', 'LastName': 'Mana', 'Affiliation': 'Section of Urology, Department of Surgery, Ljungby Hospital, Ljungby, Sweden.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Mårtensson', 'Affiliation': 'Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Richthoff', 'Affiliation': 'Section of Urology, Department of Surgery, Ljungby Hospital, Ljungby, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Sundqvist', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kjölhede', 'Affiliation': 'Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Bratt', 'Affiliation': 'Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Liedberg', 'Affiliation': 'Department of Translational Medicine, Lund University, Malmö, Sweden.'}]",Scandinavian journal of urology,['10.1080/21681805.2019.1628102']
3163,30476258,"Weight-related quality of life and temperament as predictors and moderators of outcomes among treatment-seeking, low-income, ethnically diverse children with obesity.","Within any childhood obesity treatment program, some children have better outcomes than others. Little is known about predictors or moderators of more positive outcomes. We aimed to identify whether child temperament and weight-related quality of life predict or moderate childhood obesity treatment outcomes at 6 months. From 2015 to 2016, children (n = 97) ages 5-11 years old with obesity were randomized to a clinic-community (Bull City Fit) or a clinic-only treatment program. Linear regression was used to explore whether dimensions of child temperament and weight-related quality of life predicted or moderated 6-month anthropometric and physical activity outcomes. Children who had more social avoidance due to their weight at baseline had significantly better improvements in body fat percent in the clinic-community model compared with the clinic-only model at 6 months. Across programs, better baseline social quality of life predicted greater increases in waist circumference; conversely, better physical quality of life predicted a decrease in percent of the 95th percentile. Also, children with longer attention spans had greater increases in physical activity. Our findings suggest that children who have social avoidance due to their weight may benefit most from comprehensive clinic-community treatment. Weight-related quality of life may influence outcomes across all treatments, and practitioners need to carefully counsel children experiencing weight negatively.",2020,Children who had more social avoidance due to their weight at baseline had significantly better improvements in body fat percent in the clinic-community model compared with the clinic-only model at 6 months.,"['children with longer attention spans', 'From 2015 to 2016, children (n = 97) ages 5-11 years old with obesity', 'ethnically diverse children with obesity']",['clinic-community (Bull City Fit) or a clinic-only treatment program'],"['physical quality of life', 'waist circumference', 'child temperament and weight-related quality of life predicted or moderated 6-month anthropometric and physical activity outcomes', 'baseline social quality of life', 'physical activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.029497,Children who had more social avoidance due to their weight at baseline had significantly better improvements in body fat percent in the clinic-community model compared with the clinic-only model at 6 months.,"[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Frerichs', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Smith', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lyden', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kiah', 'Initials': 'K', 'LastName': 'Gaskin', 'Affiliation': 'Department of Pediatrics, School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Asheley', 'Initials': 'A', 'LastName': 'Skinner', 'Affiliation': 'Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Armstrong', 'Affiliation': 'Department of Pediatrics, School of Medicine, Duke University, Durham, NC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby115']
3164,29611518,"3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial.","BACKGROUND


6 months of oxaliplatin-containing chemotherapy is usually given as adjuvant treatment for stage 3 colorectal cancer. We investigated whether 3 months of oxaliplatin-containing chemotherapy would be non-inferior to the usual 6 months of treatment.
METHODS


The SCOT study was an international, randomised, phase 3, non-inferiority trial done at 244 centres. Patients aged 18 years or older with high-risk stage II and stage III colorectal cancer underwent central randomisation with minimisation for centre, choice of regimen, sex, disease site, N stage, T stage, and the starting dose of capecitabine. Patients were assigned (1:1) to receive 3 months or 6 months of adjuvant oxaliplatin-containing chemotherapy. The chemotherapy regimens could consist of CAPOX (capecitabine and oxaliplatin) or FOLFOX (bolus and infused fluorouracil with oxaliplatin). The regimen was selected before randomisation in accordance with choices of the patient and treating physician. The primary study endpoint was disease-free survival and the non-inferiority margin was a hazard ratio of 1·13. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who started study treatment. This trial is registered with ISRCTN, number ISRCTN59757862, and follow-up is continuing.
FINDINGS


6088 patients underwent randomisation between March 27, 2008, and Nov 29, 2013. The intended treatment was FOLFOX in 1981 patients and CAPOX in 4107 patients. 3044 patients were assigned to 3 month group and 3044 were assigned to 6 month group. Nine patients in the 3 month group and 14 patients in the 6 month group did not consent for their data to be used, leaving 3035 patients in the 3 month group and 3030 patients in the 6 month group for the intention-to-treat analyses. At the cutoff date for analysis, there had been 1482 disease-free survival events, with 740 in the 3 month group and 742 in the 6 month group. 3 year disease-free survival was 76·7% (95% CI 75·1-78·2) for the 3 month group and 77·1% (75·6-78·6) for the 6 month group, giving a hazard ratio of 1·006 (0·909-1·114, test for non-inferiority p=0·012), significantly below the non-inferiority margin. Peripheral neuropathy of grade 2 or worse was more common in the 6 month group (237 [58%] of 409 patients for the subset with safety data) than in the 3 month group (103 [25%] of 420) and was long-lasting and associated with worse quality of life. 1098 serious adverse events were reported (492 reports in the 3 month group and 606 reports in the 6 month group) and 32 treatment-related deaths occurred (16 in each group).
INTERPRETATION


In the whole study population, 3 months of oxaliplatin-containing adjuvant chemotherapy was non-inferior to 6 months of the same therapy for patients with high-risk stage II and stage III colorectal cancer and was associated with reduced toxicity and improved quality of life. Despite the fact the study was underpowered, these data suggest that a shorter duration leads to similar survival outcomes with better quality of life and thus might represent a new standard of care.
FUNDING


Medical Research Council, Swedish Cancer Society, NETSCC, and Cancer Research UK.",2018,"3 year disease-free survival was 76·7% (95% CI 75·1-78·2) for the 3 month group and 77·1% (75·6-78·6) for the 6 month group, giving a hazard ratio of 1·006 (0·909-1·114, test for non-inferiority p=0·012), significantly below the non-inferiority margin.","['1981 patients and CAPOX in 4107 patients', 'colorectal cancer (SCOT', 'Patients aged 18 years or older with high-risk stage II and stage III', 'stage 3 colorectal cancer', '6088 patients underwent randomisation between March 27, 2008, and Nov 29, 2013', '3044 patients', 'patients with high-risk stage II and stage III colorectal cancer']","['adjuvant oxaliplatin-containing chemotherapy', 'oxaliplatin-containing adjuvant chemotherapy', 'CAPOX (capecitabine and oxaliplatin) or FOLFOX (bolus and infused fluorouracil with oxaliplatin', 'oxaliplatin-containing chemotherapy', 'capecitabine', 'adjuvant oxaliplatin-fluoropyrimidine combination therapy']","['worse quality of life', 'reduced toxicity and improved quality of life', 'disease-free survival and the non-inferiority margin', '1482 disease-free survival events', 'Peripheral neuropathy of grade 2 or worse', '3 year disease-free survival', '1098 serious adverse events', 'deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",6088.0,0.281557,"3 year disease-free survival was 76·7% (95% CI 75·1-78·2) for the 3 month group and 77·1% (75·6-78·6) for the 6 month group, giving a hazard ratio of 1·006 (0·909-1·114, test for non-inferiority p=0·012), significantly below the non-inferiority margin.","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Iveson', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK. Electronic address: tim.iveson@uhs.nhs.uk.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kerr', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'The Christie Hospital, Manchester, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hollander', 'Affiliation': 'Department of Oncology and Palliative Care, Zealand University Hospital, Naestved, Denmark.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, CIBERONC, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Australasian Gastro-Intestinal Trials Group, Melbourne, VIC, Australia.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'IGP, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Harkin', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Allan', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McQueen', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scudder', 'Affiliation': 'OCTO, University of Oxford, Department of Oncology, Oxford, UK.'}, {'ForeName': 'Kathleen Anne', 'Initials': 'KA', 'LastName': 'Boyd', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK; Center for Health and Policy Outcomes, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'Ashita', 'Initials': 'A', 'LastName': 'Waterston', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Medley', 'Affiliation': 'Royal United Hospital, Bath, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospital NHS Trust, Truro, UK.'}, {'ForeName': 'Sharadah', 'Initials': 'S', 'LastName': 'Essapen', 'Affiliation': ""St Luke's Cancer Centre, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.""}, {'ForeName': 'Amandeep S', 'Initials': 'AS', 'LastName': 'Dhadda', 'Affiliation': 'Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Raouf', 'Affiliation': 'Barking Havering and Redbridge University Hospital NHS Trust, Barking, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rees', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rene K', 'Initials': 'RK', 'LastName': 'Olesen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, University College London, London UK.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Azzabi', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Brighton and Sussex University Hospital Trust, Brighton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Poole Hospital, Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weaver', 'Affiliation': 'Department of Oncology, Oxford University Hospitals Foundation Trust, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gollins', 'Affiliation': 'North Wales Cancer Treatment Centre, Rhyl, UK.'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30093-7']
3165,29462004,How Surrogate Decision-Makers for Patients With Chronic Critical Illness Perceive and Carry Out Their Role.,"OBJECTIVES


Family members commonly make medical decision for patients with chronic critical illness. This study examines how family members approach this decision-making role in real time.
DESIGN


Qualitative analysis of interviews with family members in the intervention arm of a randomized controlled communication trial.
SETTINGS


Medical ICUs at four U.S. hospitals.
PARTICIPANTS


Family members of patients with chronic critical illness (adults mechanically ventilated for ≥ 7 d and expected to remain ventilated and survive for ≥ 72 hr) who participated in the active arm of a communication intervention study.
INTERVENTIONS


Family members participated in at least two content-guided, informational, and emotional support meetings led by a palliative care physician and nurse practitioner.
MEASUREMENTS AND MAIN RESULTS


Grounded theory was used for qualitative analysis of 66 audio recordings of meetings with 51 family members. Family members perceived their role in four main ways: voice of the patient, advocate for the patient, advocate for others, and advocate for oneself. Their decision-making was characterized by balancing goals, sharing their role, keeping perspective, remembering previous experiences, finding sources of strength, and coping with various burdens.
CONCLUSIONS


Family members take a multifaceted approach as they participate in decision-making. Understanding how surrogates perceive and act in their roles may facilitate shared decision-making among clinicians and families during critical care.",2018,"Family members perceived their role in four main ways: voice of the patient, advocate for the patient, advocate for others, and advocate for oneself.","['Family members of patients with chronic critical illness (adults mechanically ventilated for ≥ 7 d and expected to remain ventilated and survive for ≥ 72\u2009hr) who participated in the active arm of a communication intervention study', 'patients with chronic critical illness', 'Patients', 'Medical ICUs at four U.S. hospitals']","['Family members participated in at least two content-guided, informational, and emotional support meetings led by a palliative care physician and nurse practitioner']",[],"[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0586875', 'cui_str': 'Palliative care physician (occupation)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}]",[],,0.0488163,"Family members perceived their role in four main ways: voice of the patient, advocate for the patient, advocate for others, and advocate for oneself.","[{'ForeName': 'Lingsheng', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, MD.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Nelson', 'Affiliation': 'Departments of Medicine and Anesthesia & Critical Care Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': 'Division of Geriatric Medicine & Palliative Care Program, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Carson', 'Affiliation': 'Pulmonary Diseases and Critical Care Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Chai', 'Affiliation': 'Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Danis', 'Affiliation': 'Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD.'}]",Critical care medicine,['10.1097/CCM.0000000000003035']
3166,32088296,"Effects of Colesevelam on Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression in Patients With Bile Acid Diarrhea in a Randomized Trial.","BACKGROUND & AIMS


Approximately one-third of patients with IBS-diarrhea (IBS-D) have increased bile acid (BA) synthesis or excretion. An open-label study showed benefits of colesevelam on bowel functions, consistent with luminal BA sequestration by colesevelam. We compared the effects of colesevelam vs placebo on symptoms and gene expression patterns in the sigmoid colon mucosa in patients with BA diarrhea associated with IBS-D.
METHODS


We performed a double-blind, parallel-group study of 30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center. Patients were randomly assigned (1:1) to groups given colesevelam (3 tablets, 625 mg each) or matching placebo, orally twice daily for 4 weeks. Stool diaries documented bowel functions for 8 days before and 28 days during colesevelam or placebo. Stool and fasting serum samples were collected for analyses of fecal BAs and serum levels of C4 and FGF19. We measured colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels in rectosigmoid biopsies. All measurements were made at baseline and on the last days of treatment. The primary endpoints were change in total fecal BA concentration and stool consistency.
RESULTS


Compared with placebo, colesevelam was associated with significant changes in sequestered fecal total BA excretion (P < .001) and serum levels of C4 and FGF19 (both P < .001), and with a mean increase in fecal level of deoxycholic acid (10%; P = .07) compared to placebo. Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline. Stool frequency and consistency, colonic transit, and permeability did not differ significantly between groups. Colesevelam was well tolerated.
CONCLUSIONS


In a randomized trial, we found that colesevelam increases delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors. Larger studies are needed to determine the effects on clinical responses. ClinicalTrials.gov no: NCT03270085.",2020,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","['Patients with Bile Acid Diarrhea', '30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center', 'patients with BA diarrhea associated with IBS-D']","['Colesevelam', 'colesevelam vs placebo', 'placebo', 'colesevelam (3 tablets, 625 mg each) or matching placebo']","['delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors', 'colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels', 'Stool frequency and consistency, colonic transit, and permeability', 'tolerated', 'bile acid (BA) synthesis or excretion', 'total fecal BA concentration and stool consistency', 'sequestered fecal total BA excretion (P<.001) and serum levels of C4 and FGF19', 'Stool and fasting serum samples', 'Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression', 'colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1', 'fecal level of deoxycholic acid', 'fecal BAs and serum levels of C4 and FGF19']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4524087', 'cui_str': 'Bile acid diarrhea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0011479', 'cui_str': 'Deoxycholic Acid'}]",30.0,0.381983,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vijayvargiya', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota. Electronic address: camilleri.michael@mayo.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carlson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sara Linker', 'Initials': 'SL', 'LastName': 'Nord', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryks', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Rhoten', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Busciglio', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lueke', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Donato', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.027']
3167,31615643,"Complexity, symmetry and variability of forward and backward walking at different speeds and transfer effects on forward walking: Implications for neural control.","This study aimed to investigate effects of walking direction and speed on gait complexity, symmetry and variability as indicators of neural control mechanisms, and if a period of backward walking has acute effects on forward walking. Twenty-two young adults attended 2 visits. In each visit participants walked forwards at preferred walking speed (PWS) for 3-minutes (pre) followed by 5-minutes walking each at 80%, 100% and 120% of PWS of either forward or backward walking then a further 3-minutes walking forward at PWS (post). The order of walking speed in each visit was randomised and walking direction of each visit was randomised. An inertial measurement unit was placed over L5 vertebra to record tri-axial accelerations. From the trunk accelerations multiscale entropy, harmonic ratio and stride time variability were calculated to measure complexity, symmetry and variability for each walk. Complexity increased with increasing walking speed for all axes in forward and backward walking, and backward walking was less complex than forward walking. Stride time variability was also greater in backward than forward walking. Anterio-posterior and medio-lateral complexity increased following forward and backward walking but there was no difference between forward and backward walking post effects. No effects were found for harmonic ratio. These results suggest during backward walking trunk motion is rigidly controlled but central pattern generators responsible for temporal gait patterns are less refined for backward walking. However, in both directions complexity increased as speed increased suggesting additional constraint of trunk motion, normally characterised by reduced complexity, is not applied as speed increases.",2019,Anterio-posterior and medio-lateral complexity increased following forward and backward walking but there was no difference between forward and backward walking post effects.,['Twenty-two young adults attended 2 visits'],['walking direction and speed'],"['harmonic ratio and stride time variability', 'Stride time variability', 'Anterio-posterior and medio-lateral complexity', 'Complexity, symmetry and variability of forward and backward walking', 'harmonic ratio']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}]",22.0,0.0272654,Anterio-posterior and medio-lateral complexity increased following forward and backward walking but there was no difference between forward and backward walking post effects.,"[{'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Walsh', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Oxford Brookes University, Oxford OX23 0BP, UK. Electronic address: gwalsh@brookes.ac.uk.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Taylor', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Oxford Brookes University, Oxford OX23 0BP, UK.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109377']
3168,31519496,Comparing cognitive load levels among family members of the critically ill exposed to electronic decision aids.,"Cognitive load predicts one's ability to process information and learn from decision support interventions. The present study compared intrinsic and extraneous cognitive load levels resulting from exposure to two different electronic decision aids. A convenience sample of ninety-seven surrogate decision makers for critically ill patients were randomly assigned to receive either a single dose of a video-based or avatar-based decision aid. Intrinsic and extraneous cognitive load levels among recipients of the video-based decision support resource were lower than recipients of the avatar-based decision support resource. After controlling for age, the observed differences in intrinsic cognitive load were not significantly different, whereas the observed differences in extraneous cognitive load remained. Extraneous cognitive load is a modifiable factor to consider for future developers of decision support interventions that may determine the efficacy of efforts to support patients and family members with decision making.",2019,Intrinsic and extraneous cognitive load levels among recipients of the video-based decision support resource were lower than recipients of the avatar-based decision support resource.,"['A convenience sample of ninety-seven surrogate decision makers for critically ill patients', 'family members of the critically ill exposed to electronic decision aids']",['video-based or avatar-based decision aid'],['intrinsic cognitive load'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}]",97.0,0.0338384,Intrinsic and extraneous cognitive load levels among recipients of the video-based decision support resource were lower than recipients of the avatar-based decision support resource.,"[{'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'Pignatiello', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America. Electronic address: gap54@case.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Daly', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Heath', 'Initials': 'H', 'LastName': 'Demaree', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Hickman', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151192']
3169,30775818,A walk on water: comparing the influence of Ai Chi and Tai Chi on fall risk and verbal working memory in ageing people with intellectual disabilities - a randomised controlled trial.,"BACKGROUND


Aquatic motor intervention has been found to be effective in reducing falls and improving verbal working memory among the general population. However, effects among older adults with intellectual disabilities (ID) have never been explored. The aim of this study was to examine the effects of aquatic motor intervention on fall risk and verbal working memory among older adults with ID.
METHODS


Forty-one older adults with mild to moderate ID (age: 50-66 years) were randomly assigned to 14 weeks of aquatic motor intervention (Ai Chi: N = 19) or identical on-land motor intervention (Tai Chi: N = 22). Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory, measured with the digit span forward test, were assessed pre-intervention, after 7 weeks of intervention and post-intervention.
RESULTS


Study results indicate positive effects of both aquatic and on-land motor intervention on TBAT fall risk score, while the aquatic motor intervention group improved TBAT fall risk score quicker as compared with the on-land motor intervention group. Moreover, the lower the pre-intervention TBAT score was, the higher the improvement. In addition, study findings support the positive effects of aquatic motor intervention on verbal working memory ability as measured with the digit span forward test.
CONCLUSIONS


Motor intervention, and particularly in an aquatic environment, can potentially reduce fall risk. Aquatic motor intervention may help to improve verbal working memory among older adults with ID.",2019,"Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory, measured with the digit span forward test, were assessed pre-intervention, after 7 weeks of intervention and post-intervention.
","['older adults with intellectual disabilities (ID', 'older adults with ID', 'ageing people with intellectual disabilities ', 'Forty-one older adults with mild to moderate ID (age: 50-66\xa0years']","['aquatic motor intervention', 'Aquatic motor intervention', 'Ai Chi and Tai Chi', 'aquatic motor intervention (Ai Chi: N\xa0=\xa019) or identical on-land motor intervention (Tai Chi: N\xa0=\xa022']","['fall risk and verbal working memory', 'verbal working memory', 'pre-intervention TBAT score', 'Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory', 'TBAT fall risk score', 'TBAT fall risk score quicker', 'verbal working memory ability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1960377', 'cui_str': 'Assessment of sense of balance (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",41.0,0.0265963,"Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory, measured with the digit span forward test, were assessed pre-intervention, after 7 weeks of intervention and post-intervention.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nissim', 'Affiliation': 'The Gonda Multidisciplinary Brain Research Center, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hutzler', 'Affiliation': 'The Academic College at Wingate, Netanya, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'The Gonda Multidisciplinary Brain Research Center, Bar-Ilan University, Ramat-Gan, Israel.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12602']
3170,29802852,Efficacy and Safety of Curcumin in Treatment of Intestinal Adenomas in Patients With Familial Adenomatous Polyposis.,"BACKGROUND & AIMS


Familial adenomatous polyposis is an autosomal dominant disorder characterized by the development of hundreds of colorectal adenomas and eventually colorectal cancer. Oral administration of the spice curcumin has been followed by regression of polyps in patients with this disorder. We performed a double-blinded randomized trial to determine the safety and efficacy of curcumin in patients with familial adenomatous polyposis.
METHODS


This study included 44 patients with familial adenomatous polyposis (18-85 years old) who had not undergone colectomy or had undergone colectomy with ileorectal anastomosis or ileal anal pouches, had at least 5 intestinal adenomatous polyps, and had enrolled in Puerto Rico or the United States from September 2011 through November 2016. Patients were randomly assigned (1:1) to groups given 100% pure curcumin (1,500 mg orally, twice per day) or identical-appearing placebo capsules for 12 months. The number and size of lower gastrointestinal tract polyps were evaluated every 4 months for 1 year. The primary outcome was the number of polyps in the curcumin and placebo groups at 12 months or at the time of withdrawal from the study according to the intention-to-treat principle.
RESULTS


After 1 year of treatment, the average rate of compliance was 83% in the curcumin group and 91% in the placebo group. After 12 weeks, there was no significant difference in the mean number of polyps between the placebo group (18.6; 95% CI, 9.3-27.8) and the curcumin group (22.6; 95% CI, 12.1-33.1; P = .58). We found no significant difference in mean polyp size between the curcumin group (2.3 mm; 95% CI, 1.8-2.8) and the placebo group (2.1 mm; 95% CI, 1.5-2.7; P = .76). Adverse events were few, with no significant differences between groups.
CONCLUSIONS


In a double-blinded randomized trial of patients with familial adenomatous polyposis, we found no difference in the mean number or size of lower intestinal tract adenomas between patients given curcumin 3,000 mg/day and those given placebo for 12 weeks. Clinicaltrials.gov ID NCT00641147.",2018,"Adverse events were few, with no significant differences between groups.
","['44 patients with familial adenomatous polyposis (18-85 years old) who had not undergone colectomy or had undergone colectomy with ileorectal anastomosis or ileal anal pouches, had at least 5 intestinal adenomatous polyps, and had enrolled in Puerto Rico or the United States from September 2011 through November 2016', 'patients with familial adenomatous polyposis', 'Patients With Familial Adenomatous Polyposis', 'patients with this disorder']","['Curcumin', 'placebo', '100% pure curcumin (1,500 mg orally, twice per day) or identical-appearing placebo', 'curcumin']","['safety and efficacy', 'mean polyp size', 'Adverse events', 'number of polyps', 'number and size of lower gastrointestinal tract polyps', 'mean number of polyps', 'mean\xa0number or size of lower intestinal tract adenomas', 'Efficacy and Safety', 'average rate of compliance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032580', 'cui_str': 'Polyposis Coli, Familial'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C0192754', 'cui_str': 'Ileorectostomy (procedure)'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C4319584', 'cui_str': 'Pouch (unit of presentation)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0206677', 'cui_str': 'Adenomatous Polyps'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299212', 'cui_str': 'Polyp size'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0226875', 'cui_str': 'Lower Gastrointestinal Tract'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",44.0,0.607764,"Adverse events were few, with no significant differences between groups.
","[{'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Cruz-Correa', 'Affiliation': 'Department of Medicine and Biochemistry, University of Puerto Rico School of Medicine, Medical Sciences Campus, San Juan, Puerto Rico; University of Puerto Rico Comprehensive Cancer Center, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Hylind', 'Affiliation': 'Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jessica Hernandez', 'Initials': 'JH', 'LastName': 'Marrero', 'Affiliation': 'Department of Medicine and Biochemistry, University of Puerto Rico School of Medicine, Medical Sciences Campus, San Juan, Puerto Rico; University of Puerto Rico Comprehensive Cancer Center, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Marianna L', 'Initials': 'ML', 'LastName': 'Zahurak', 'Affiliation': 'Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Murray-Stewart', 'Affiliation': 'Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Casero', 'Affiliation': 'Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Montgomery', 'Affiliation': 'Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Iacobuzio-Donahue', 'Affiliation': 'Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Pathology, Memorial Sloan Kettering, New York, New York.'}, {'ForeName': 'Lodewijk A', 'Initials': 'LA', 'LastName': 'Brosens', 'Affiliation': 'Utrecht Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'G Johan', 'Initials': 'GJ', 'LastName': 'Offerhaus', 'Affiliation': 'Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Utrecht Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Giardiello', 'Affiliation': 'Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: fgiardi@jhmi.edu.'}]",Gastroenterology,['10.1053/j.gastro.2018.05.031']
3171,31059579,Effect of Cyclotorsion Compensation With a Novel Technique in Small Incision Lenticule Extraction Surgery for the Correction of Myopic Astigmatism.,"PURPOSE


To comparatively investigate the clinical outcomes of small incision lenticule extraction (SMILE) surgery with or without cyclotorsion compensation for the correction of myopic astigmatism.
METHODS


This prospective, double-blinded, randomized controlled trial included patients who underwent SMILE surgery with bilateral myopic astigmatism. Two eyes of a single patient were randomly divided into the static cyclotorsion compensation (SCC) group and the control group. In the SCC group, the intraoperative cyclotorsion was manually compensated with a novel technique. In the control group, the cyclotorsion was not compensated. Visual acuity, manifest refraction, aberrations, objective visual quality, and contrast sensitivity were measured preoperatively and postoperatively.
RESULTS


A total of 132 eyes from 66 patients were analyzed at the 3-month follow-up. The mean preoperative cylinder values in the SCC and control groups were -1.52 ± 0.81 and -1.57 ± 0.82 diopters (D), respectively. The mean cyclotorsion during surgery was 0.60° ± 0.63° (range: 0° to 3.2°) in the SCC group and 3.21° ± 2.33° (range: 0.1° to 10.8°) in the control group (P < .001). Both groups showed favorable results in the correction of myopic astigmatism. No statistically significant difference was found between the two groups in visual and refractive outcomes, vector parameters, entire eye aberrations, objective visual quality, or contrast sensitivity. No significant benefit was gained from cyclotorsion compensation, even in the high astigmatism subgroup.
CONCLUSIONS


The cyclotorsion compensation technique used in this study helped minimize the alignment error but was not compulsory because the ocular rotation in SMILE surgery using a well-controlled position was too small to affect the astigmatic outcomes or postoperative visual quality. [J Refract Surg. 2019;35(5):301-308.].",2019,"No statistically significant difference was found between the two groups in visual and refractive outcomes, vector parameters, entire eye aberrations, objective visual quality, or contrast sensitivity.","['patients who underwent SMILE surgery with bilateral myopic astigmatism', 'A total of 132 eyes from 66 patients were analyzed at the 3-month follow-up', 'Two eyes of a single patient']","['small incision lenticule extraction (SMILE) surgery with or without cyclotorsion compensation', 'static cyclotorsion compensation (SCC', 'Cyclotorsion Compensation']","['mean cyclotorsion', 'mean preoperative cylinder values', 'visual and refractive outcomes, vector parameters, entire eye aberrations, objective visual quality, or contrast sensitivity', 'Visual acuity, manifest refraction, aberrations, objective visual quality, and contrast sensitivity', 'intraoperative cyclotorsion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280202', 'cui_str': 'Entire eye'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1301318', 'cui_str': 'M-Manifest refraction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",66.0,0.0680725,"No statistically significant difference was found between the two groups in visual and refractive outcomes, vector parameters, entire eye aberrations, objective visual quality, or contrast sensitivity.","[{'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Shengbei', 'Initials': 'S', 'LastName': 'Weng', 'Affiliation': ''}, {'ForeName': 'Limian', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Haiqin', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20190402-01']
3172,28441958,Metformin to Augment Strength Training Effective Response in Seniors (MASTERS): study protocol for a randomized controlled trial.,"BACKGROUND


Muscle mass and strength are strong determinants of a person's quality of life and functional independence with advancing age. While resistance training is the most effective intervention to combat age-associated muscle atrophy (sarcopenia), the ability of older adults to increase muscle mass and strength in response to training is blunted and highly variable. Thus, finding novel ways to complement resistance training to improve muscle response and ultimately quality of life among older individuals is critical. The purpose of this study is to determine whether a commonly prescribed medication called metformin can be repurposed to improve the response to resistance exercise training by altering the muscle tissue inflammatory environment.
METHODS/DESIGN


Individuals aged 65 and older are participating in a two-site, randomized, double-blind, placebo-controlled trial testing the effects of metformin or placebo on muscle size, strength, and physical function when combined with a progressive resistance training program. Participants consume 1700 mg of metformin per day or placebo for 2 weeks before engaging in a 14-week progressive resistance training regimen, with continued metformin or placebo. Participants are then monitored post-training to determine if the group taking metformin derived greater overall benefit from training in terms of muscle mass and strength gains than those on placebo. Muscle biopsies are taken from the vastus lateralis at three time points to assess individual cellular and molecular adaptations to resistance training and also changes in response to metformin.
DISCUSSION


The response of aged muscles to a resistance training program does not always result in a positive outcome; some individuals even experience a loss in muscle mass following resistance training. Thus, adjuvant therapies, including pharmacological ones, are required to optimize response to training in those who do not respond and may be at increased risk of frailty. This is the first known metformin repurposing trial in non-diseased individuals, aimed specifically at the resistance exercise ""non-responder"" phenotype present in the aging population. The overall goal of this trial is to determine if combined exercise-metformin intervention therapy will benefit older individuals by promoting muscle hypertrophy and strength gains, thereby maintaining functional independence.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02308228 . Registered on 25 November 2014.",2017,Participants are then monitored post-training to determine if the group taking metformin derived greater overall benefit from training in terms of muscle mass and strength gains than those on placebo.,"['Seniors (MASTERS', 'Individuals aged 65 and older are participating in a two-site']","['placebo', 'metformin', 'metformin per day or placebo', 'metformin or placebo', 'combined exercise-metformin intervention therapy', 'progressive resistance training program', 'Metformin', 'resistance training program']","['muscle size, strength, and physical function']","[{'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.124096,Participants are then monitored post-training to determine if the group taking metformin derived greater overall benefit from training in terms of muscle mass and strength gains than those on placebo.,"[{'ForeName': 'Doug E', 'Initials': 'DE', 'LastName': 'Long', 'Affiliation': 'College of Health Sciences and Center for Muscle Biology, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Bailey D', 'Initials': 'BD', 'LastName': 'Peck', 'Affiliation': 'College of Health Sciences and Center for Muscle Biology, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Martz', 'Affiliation': 'Center for Exercise Medicine and Department of Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'Center for Exercise Medicine and Department of Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'Center for Exercise Medicine and Department of Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kern', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, and Barnstable Brown Diabetes and Obesity Center, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Center for Exercise Medicine and Department of Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Peterson', 'Affiliation': 'College of Health Sciences and Center for Muscle Biology, University of Kentucky, Lexington, KY, USA. cpete4@uky.edu.'}]",Trials,['10.1186/s13063-017-1932-5']
3173,28744522,The effects of multi mineral-vitamin D and vitamins (C+E) supplementation in the prevention of preeclampsia: An RCT.,"BACKGROUND


Several studies have reported the uncertain role of multi-minerals and vitamins in the prevention of preeclampsia.
OBJECTIVE


The present study aims to investigate the effect of multimineral-vitamin D supplements (calcium, magnesium, zinc and Vitamin D) and vitamins (C+ E) in the prevention of preeclampsia.
MATERIALS AND METHODS


In this randomized clinical trial, 90 pregnant women were divided into three groups: group A received Ferrous sulfate (1 tablet/day) + one tablet of Claci-care multimineral-vitamin D containing 800mg calcium, 200mg magnesium, 8mg zinc and 400 IU Vitamin D3 per day; group B received Ferrous sulfate (1 tablet/day) + 250 mg vitamin C + 55 mg vitamin E; and the controls received only one Ferrous sulfate tablet daily.
RESULTS


The incidence of preeclampsia in group A was significantly lower than the control group (p=0.03), while there was no significant difference between group B and controls (p=0.50), as well as groups A and B (p=0.063). The incidence of neonatal complications in the group A was significantly lower than the control group (p=0.01), while there was no significant difference between group B and control (p=0.48).
CONCLUSION


According to the results, calcium, magnesium, and zinc supplements have a significant effect on the prevention of preeclampsia. In addition, prescription of multimineral-vitamin D during pregnancy can be a low-cost and affordable way to reduce the incidence of preeclampsia in women who are at high risk of preeclampsia.",2017,"A was significantly lower than the control group (p=0.01), while there was no significant difference between group B and control (p=0.48).
","['women who are at high risk of preeclampsia', '90 pregnant women']","['calcium, magnesium, and zinc supplements', 'multi mineral-vitamin D and vitamins (C+E) supplementation', 'Ferrous sulfate (1 tablet/day) + one tablet of Claci-care multimineral-vitamin D containing 800mg calcium, 200mg magnesium, 8mg zinc and 400 IU Vitamin D3 per day; group B received Ferrous sulfate (1 tablet/day) + 250 mg vitamin C + 55 mg vitamin E; and the controls received only one Ferrous sulfate tablet daily', 'multimineral-vitamin D supplements (calcium, magnesium, zinc and Vitamin D) and vitamins (C+ E']","['neonatal complications', 'prevention of preeclampsia', 'preeclampsia', 'incidence of preeclampsia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",90.0,0.210051,"A was significantly lower than the control group (p=0.01), while there was no significant difference between group B and control (p=0.48).
","[{'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Azami', 'Affiliation': 'Student Research Committee, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Tayebe', 'Initials': 'T', 'LastName': 'Azadi', 'Affiliation': 'Nursing and Midwifery Faculty, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Sepidezahra', 'Initials': 'S', 'LastName': 'Farhang', 'Affiliation': 'Faculty of Medicine, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Shoobo', 'Initials': 'S', 'LastName': 'Rahmati', 'Affiliation': 'Student Research Committee, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Pourtaghi', 'Affiliation': 'Nursing and Midwifery Faculty, Ilam University of Medical Sciences, Ilam, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
3174,30118625,A Novel Infant Chest Compression Assist Device Using a Palm Rather Than Fingers: A Randomized Crossover Trial.,"Objective:  We developed a novel compression assist device (palm presser) to perform chest compressions using a palm in infant cardiopulmonary resuscitation (CPR). We hypothesized that the palm presser will increase compression depth without increasing hands-off time and will reduce rescuer fatigue compared with the two-finger technique (TFT). Methods:  In this randomized crossover manikin trial, participants performed two minutes of CPR with a 30:2 compression:ventilation ratio using the palm presser and the TFT in randomized sequence on an infant manikin. CPR parameters, including compression depth and hands-off time, were collected to compare CPR quality between the palm presser and the TFT. The linear mixed-effect model was used to control the carryover effect of a crossover design in the analysis of CPR parameters. To evaluate rescuer fatigue, we compared changes in compression depth over time and calculated the odds of sufficiently deep compressions over time between the two groups. Results:  The palm presser resulted in greater mean compression depth (41.5 ± 1.6 mm vs. 36.8 ± 5.5 mm, p < 0.001), greater sufficiently deep compressions (80.9 ± 27.8% vs. 42.4 ± 35.4%, p < 0.001), and better correct hand position (99.9 ± 0.5% vs. 83.9 ± 25.3%, p = 0.013) than the TFT. Total compressions, compression rate, total ventilations, volume of ventilations, and hands-off time were not significantly different between the two groups. The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024 [95% CI -0.030 to -0.018] vs. -0.004 [95% CI -0.006 to -0.002]). The odds of a compression depth greater than 40 mm increased 2.8 times (95% CI 2.2 to 3.4) with the TFT during the first minute compared with the last minute, whereas the corresponding odds ratio when using the palm presser was not significantly different in the first and last minutes (OR: 1.2 [95% CI 0.9 to 1.5]). Conclusions:  Compression with palm pressers resulted in greater compression depth without increasing hands-off time and reduced rescuer fatigue compared with compression with the TFT in simulated infant CPR with manikins.",2019,The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024,['Than Fingers'],"['CPR with a 30:2 compression:ventilation ratio using the palm presser and the TFT', 'novel compression assist device (palm presser) to perform chest compressions using a palm in infant cardiopulmonary resuscitation (CPR', 'TFT']","['odds of a compression depth', 'rescuer fatigue', 'mean change in compression depth over time', 'Total compressions, compression rate, total ventilations, volume of ventilations, and hands-off time', 'compression depth', 'mean compression depth', 'CPR parameters, including compression depth and hands-off time', 'CPR quality']","[{'cui': 'C0016129', 'cui_str': 'Fingers'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0335367', 'cui_str': 'Presser (hand) (occupation)'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0644301,The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024,"[{'ForeName': 'Joong Wan', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jae Yun', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Joonghee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Kwak', 'Affiliation': ''}, {'ForeName': 'Do Kyun', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jung Chan', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Eun Mi', 'Initials': 'EM', 'LastName': 'Ham', 'Affiliation': ''}, {'ForeName': 'Soyun', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Hyuksool', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2018.1471559']
3175,31020621,Using a Culturally Tailored Narrative to Increase Cervical Cancer Detection Among Spanish-Speaking Mexican-American Women.,"The objective of this study was to determine the feasibility and effectiveness of translating films, and whether the use of narrative is an effective vehicle for producing changes in knowledge, attitudes, and behaviors regarding cervical cancer compared with a nonnarrative film. A randomized controlled telephone trial surveyed the effectiveness of two films our team produced among a sample of 300 monolingual Spanish-speaking women, ages 25 to 45, who were of Mexican origin. Participants were recruited using random digit dialing (RDD) procedures from 2013 to 2014 in Los Angeles County and were randomly selected to view either a narrative or nonnarrative film. Data were collected by phone at baseline, 2 weeks, and 6 months after viewing. On average, participants arrived in the USA 25 years ago. The majority reported having less than high school education and limited English proficiency. Compared with their nonnarrative counterparts, women who received the cervical cancer-related information in the narrative film showed a significantly greater increase in new knowledge (p = 0.01) and in supportive attitudes about Pap tests expense (p = 0.05). Importantly, at 6 months, although not statistically significant, women who viewed the narrative film were also more likely to have had or scheduled a Pap test (62% vs 42%). Narratives are a useful and underutilized tool to communicate information about cancer prevention. These findings have important implications for the delivery of health education among Spanish-speaking, low-literacy immigrant women, and for the reduction of cancer-related disparities.",2020,"Importantly, at 6 months, although not statistically significant, women who viewed the narrative film were also more likely to have had or scheduled a Pap test (62% vs 42%).","['300 monolingual Spanish-speaking women, ages 25 to 45, who were of Mexican origin', 'Participants were recruited using random digit dialing (RDD) procedures from 2013 to 2014 in Los Angeles County', 'Spanish-Speaking Mexican-American Women']","['Culturally Tailored Narrative', 'narrative or nonnarrative film']","['supportive attitudes about Pap tests expense', 'new knowledge']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0025884', 'cui_str': 'Chicanas'}]","[{'cui': 'C4319646', 'cui_str': 'Film'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0282794,"Importantly, at 6 months, although not statistically significant, women who viewed the narrative film were also more likely to have had or scheduled a Pap test (62% vs 42%).","[{'ForeName': 'Carol Y', 'Initials': 'CY', 'LastName': 'Ochoa', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, 2001 N. Soto Street, Los Angeles, CA, 90033, USA. caroloch@usc.edu.'}, {'ForeName': 'Sheila T', 'Initials': 'ST', 'LastName': 'Murphy', 'Affiliation': 'Annenberg School for Communication and Journalism, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Frank', 'Affiliation': 'Department of Communication, Portland State University, Portland, OR, USA.'}, {'ForeName': 'Lourdes A', 'Initials': 'LA', 'LastName': 'Baezconde-Garbanati', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, and Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01521-6']
3176,30898938,"SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study.","BACKGROUND


Radical hysterectomy and complete pelvic lymphadenectomies are the most commonly performed procedures for women with early-stage cervical cancer. Sentinel lymph node (SLN) mapping could be an alternative to routine pelvic lymphadenectomy, aiming to diagnose accurately nodal extension and decrease lymphatic morbidity.
PRIMARY OBJECTIVE


To compare 3-year disease-free survival and health-related quality of life after SLN biopsy or SLN biopsy + pelvic lymphadenectomy in early cervical cancer.
STUDY HYPOTHESIS


We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy.
TRIAL DESIGN


International, randomized, multicenter, single-blind trial. The study will be run by teams trained to carry out SLN biopsy, belonging to clinical research cooperative groups or recognized as experts in this field. Patients with an optimal mapping (Memorial Sloan Kettering Cancer Center [MSKCC] criteria) and a negative frozen section will be randomized 1:1 to SLN biopsy only or SLN biopsy + pelvic lymphadenectomy.
INCLUSION, EXCLUSION CRITERIA


Patients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease. Histological types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
PRIMARY ENDPOINT


Main endpoint will be co-primary endpoint, associating 3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24).
SAMPLE SIZE


950 patients need to be randomized.Estimated dates for completing accrual and presenting results: study started on Q2 2018, last accrual is scheduled for Q2 2021, and last follow-up in Q2 2026.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03386734.",2019,"HYPOTHESIS


We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy.
","['Patients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease', 'Patients with an optimal mapping (Memorial Sloan Kettering Cancer Center [MSKCC] criteria) and a negative frozen section', 'women with early-stage cervical cancer', 'in early cervical cancer']","['sentinel node biopsy', 'SLN biopsy + pelvic lymphadenectomy', 'SLN biopsy only or SLN biopsy + pelvic lymphadenectomy', 'SLN biopsy or SLN biopsy + pelvic lymphadenectomy', 'Radical hysterectomy and complete pelvic lymphadenectomies']","['3-year disease-free survival and health-related quality of life', '3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0016741', 'cui_str': 'Frozen Sections'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}, {'cui': 'C0439796', 'cui_str': 'Biopsy only (qualifier value)'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",950.0,0.155854,"HYPOTHESIS


We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy.
","[{'ForeName': 'Fabrice R', 'Initials': 'FR', 'LastName': 'Lecuru', 'Affiliation': 'Gynecologic and Oncologic Surgery, GINECO, Georges Pompidou European Hospital, Paris, France fabrice.lecuru@aphp.fr.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McCormack', 'Affiliation': 'NRCI, UK, UCLH London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': 'Klinik fur Frauenheilkunde und Geburtshilfe, AGO, Medizinische Hochschule, Hannover, Germany.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Statistics, GINECO, Centre Hospitalier Universitaire de Besancon, Besancon, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Leitao', 'Affiliation': 'Gynecologic Oncology, Memorial Sloan-Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois Departement de gynecologie-obstetrique et genetique medicale, Lausanne, Switzerland.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Zweemer', 'Affiliation': 'Gynecologic Oncology, DGOG, UMC Utrecht Hersencentrum Rudolf Magnus, Utrecht, UK.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Gynecologic Oncology, GOTIC, Saitama Medical University, Moroyama, Japan.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Zanagnolo', 'Affiliation': 'Gynecologic Oncology, MANGO, Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Ane Gerda', 'Initials': 'AG', 'LastName': 'Zahl Eriksson', 'Affiliation': 'Gynecologic Oncology, NSGO, Universitetet i Oslo, Oslo, Norway.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hudson', 'Affiliation': 'Gynecologic Oncology, NRCI, Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': 'Gynecologic Oncology, GINECO, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Plante', 'Affiliation': 'Gynecologic Oncology, CCTG, Fondation du CHU de Quebec, Quebec City, Quebec, Canada.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000332']
3177,27525329,The effect of endometrial injury on pregnancy rate in frozen-thawed embryo transfer: A randomized control trial.,"BACKGROUND


Implantation failure is one of the most important factors limiting success in IVF treatment. The majority of trials have demonstrated favorable effect of endometrial injury on implantation success rate especially in women with recurrent implantation failure, while some studies failed to detect any benefit.
OBJECTIVE


The purpose of our trial was to explore whether endometrial injury in luteal phase prior to frozen-thawed embryo transfer cycles would improve pregnancy outcomes?
MATERIALS AND METHODS


We conducted a prospective controlled trial of 93 consecutive subjects at a research and clinical center for infertility. All women were undergone frozen-thawed embryo transfer (FTE) cycles. Women in the experimental group underwent endometrial biopsy with a Pipelle catheter in luteal phase proceeding FET cycle. Primary outcomes were implantation and clinical pregnancy rates and secondary outcomes were chemical, ongoing and multiple pregnancy and miscarriage rates.
RESULTS


45 subjects who underwent endometrial injury (EI) were compared with 48 control group which did not include any uterine manipulation. There were no significant differences in baseline and cycle characteristics between two groups. The difference in implantation rate was trend to statistically significance, 11.8% in EI group vs. 20.5% in control group (p=0.091). The chemical, clinical and ongoing pregnancy rates were lower in EI group compared with control group but not statistically significant. The multiple pregnancy rate and miscarriage rate also were lower in EI group compared with control group.
CONCLUSION


Based on results of this study, local injury to endometrium in luteal phase prior to FET cycle had a negative impact on implantation and clinical pregnancy rates.",2016,"Primary outcomes were implantation and clinical pregnancy rates and secondary outcomes were chemical, ongoing and multiple pregnancy and miscarriage rates.
","['45 subjects who underwent endometrial injury (EI', 'All women were undergone frozen-thawed embryo transfer (FTE) cycles', 'women with recurrent implantation failure', '93 consecutive subjects at a research and clinical center for infertility']","['frozen-thawed embryo transfer', 'frozen-thawed embryo transfer cycles', 'endometrial biopsy with a Pipelle catheter']","['implantation rate', 'chemical, clinical and ongoing pregnancy rates', 'implantation and clinical pregnancy rates and secondary outcomes were chemical, ongoing and multiple pregnancy and miscarriage rates', 'multiple pregnancy rate and miscarriage rate', 'pregnancy rate', 'implantation and clinical pregnancy rates']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0035168'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}]","[{'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C1510477', 'cui_str': 'Endometrial biopsy (procedure)'}, {'cui': 'C0441192', 'cui_str': 'Pipelle (physical object)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",93.0,0.14667,"Primary outcomes were implantation and clinical pregnancy rates and secondary outcomes were chemical, ongoing and multiple pregnancy and miscarriage rates.
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Aflatoonian', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Baradaran Bagheri', 'Affiliation': 'Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Robabe', 'Initials': 'R', 'LastName': 'Hosseinisadat', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",[]
3178,31704939,"Stress and productivity patterns of interrupted, synergistic, and antagonistic office activities.","We describe a controlled experiment, aiming to study productivity and stress effects of email interruptions and activity interactions in the modern office. The measurement set includes multimodal data for n = 63 knowledge workers who volunteered for this experiment and were randomly assigned into four groups: (G1/G2) Batch email interruptions with/without exogenous stress. (G3/G4) Continual email interruptions with/without exogenous stress. To provide context, the experiment's email treatments were surrounded by typical office tasks. The captured variables include physiological indicators of stress, measures of report writing quality and keystroke dynamics, as well as psychometric scores and biographic information detailing participants' profiles. Investigations powered by this dataset are expected to lead to personalized recommendations for handling email interruptions and a deeper understanding of synergistic and antagonistic office activities. Given the centrality of email in the modern office, and the importance of office work to people's lives and the economy, the present data have a valuable role to play.",2019,"We describe a controlled experiment, aiming to study productivity and stress effects of email interruptions and activity interactions in the modern office.",['n\u2009=\u200963 knowledge workers who volunteered for this experiment'],['G1/G2) Batch email interruptions with/without exogenous stress'],"['Stress and productivity patterns of interrupted, synergistic, and antagonistic office activities', ""physiological indicators of stress, measures of report writing quality and keystroke dynamics, as well as psychometric scores and biographic information detailing participants' profiles""]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",63.0,0.0280327,"We describe a controlled experiment, aiming to study productivity and stress effects of email interruptions and activity interactions in the modern office.","[{'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Zaman', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA.'}, {'ForeName': 'Amanveer', 'Initials': 'A', 'LastName': 'Wesley', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA.'}, {'ForeName': 'Dennis Rodrigo Da Cunha', 'Initials': 'DRDC', 'LastName': 'Silva', 'Affiliation': 'Perception, Sensing, and Instrumentation Laboratory, Texas A & M University, College Station, USA.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Buddharaju', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Akbar', 'Affiliation': 'Department of Informatics, University of California, Irvine, USA.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'College of Information Studies, University of Maryland, College Park, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Mark', 'Affiliation': 'Department of Informatics, University of California, Irvine, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gutierrez-Osuna', 'Affiliation': 'Perception, Sensing, and Instrumentation Laboratory, Texas A & M University, College Station, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pavlidis', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA. ipavlidis@uh.edu.'}]",Scientific data,['10.1038/s41597-019-0249-5']
3179,31740723,Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity.,"BACKGROUND


Oxytocin (OXT), shown to decrease food intake in animal models and men, is a promising novel treatment for obesity. We have shown that in men with overweight and obesity, intranasal (IN) OXT reduced the functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent signal in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs. nonfood images. Here, we employed functional connectivity fMRI analysis, which measures the synchrony in activation between neural systems in a context-dependent manner. We hypothesized that OXT would attenuate the functional connectivity of the VTA with key food motivation brain areas only when participants viewed high-calorie food stimuli.
METHODS


This randomized, double-blind, and placebo-controlled crossover study of 24 IU IN OXT included ten men with overweight or obesity (mean ± SEM BMI: 28.9 ± 0.8 kg/m 2 ). Following drug administration, subjects completed an fMRI food motivation paradigm including images of high and low-calorie foods, nonfood objects, and fixation stimuli. A psychophysiological interaction analysis was performed with the VTA as seed region.
RESULTS


Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05). There was no difference in functional connectivity between VTA and these brain areas when comparing OXT and placebo for low-calorie food, nonfood, and fixation images.
CONCLUSION


In men with overweight and obesity, OXT attenuates the functional connectivity between the VTA and food motivation brain regions in response to high-calorie visual food images. These findings could partially explain the observed anorexigenic effect of OXT, providing insight into the mechanism through which OXT ameliorates food cue-induced reward anticipation in patients with obesity. Additional studies are ongoing to further delineate the anorexigenic effect of OXT in obesity.",2020,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","['men with overweight and obesity', 'ten men with overweight or obesity (mean\u2009±\u2009SEM BMI: 28.9\u2009±\u20090.8\u2009kg/m 2 ', 'men with overweight and obesity, intranasal (IN', 'patients with obesity']","['OXT', '24 IU IN OXT', 'placebo', 'Oxytocin', 'OXT and placebo', 'Oxytocin (OXT']","['insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods', 'functional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.191194,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Kerem', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nouchine', 'Initials': 'N', 'LastName': 'Hadjikhani', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. ealawson@partners.org.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Plessow', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. fplessow@mgh.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0489-7']
3180,31784386,Can small glenospheres with eccentricity reduce scapular notching as effectively as large glenospheres without eccentricity? A prospective randomized study.,"BACKGROUND


The objective of this study was to analyze whether small glenospheres with eccentricity were comparable to large glenospheres in scapular notch development.
METHODS


This prospective randomized study included 82 patients who had undergone a reverse shoulder arthroplasty with a 2-year follow-up period. After randomization, 43 patients were allocated to receive a 42-mm glenosphere and 39 patients were allocated to receive a 38-mm glenosphere with 2 mm of eccentricity. Scapular notch development was defined after examination of an anteroposterior radiograph at the end of follow-up. Functional outcomes were recorded using the Constant score before surgery and at the end of follow-up.
RESULTS


Scapular notch development was present in 16.6% of patients who received a 42-mm glenosphere and 34.2% of patients who received a 38-mm eccentric glenosphere. No significant difference was found between the groups with the number of cases available (P = .07). Functional outcomes significantly increased from preoperatively to postoperatively in both groups, with no significant difference found between them (P = .77). The mean glenosphere overhang measure was 6.3 mm in patients with a 42-mm glenosphere and 6.0 mm in those with a 38-mm eccentric glenosphere (P = .68). No significant differences were noted between patients with a scapular notch and patients without a scapular notch in terms of functional outcomes.
DISCUSSION


Small glenospheres with eccentricity fared slightly worse than large glenospheres regarding scapular notch development, even though no significant differences were noted. Functional outcomes were comparable between the 2 designs.",2020,"No significant differences were noted between patients with a scapular notch and patients without a scapular notch in terms of functional outcomes.
","['43 patients were allocated to receive a 42-mm glenosphere and 39 patients', '82 patients who had undergone a reverse shoulder arthroplasty with a 2-year follow-up period']",['38-mm glenosphere with 2 mm of eccentricity'],"['mean glenosphere overhang measure', 'Functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",82.0,0.062644,"No significant differences were noted between patients with a scapular notch and patients without a scapular notch in terms of functional outcomes.
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Torrens', 'Affiliation': 'Department of Orthopedics, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain. Electronic address: 86925@parcdesalutmar.cat.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Miquel', 'Affiliation': ""Department of Orthopedics, Hospital d'Igualada, Consorci Sanitari de l'Anoia, Barcelona, Spain.""}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Martínez', 'Affiliation': 'Department of Orthopedics, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santana', 'Affiliation': 'Department of Orthopedics, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.09.030']
3181,31592939,The Effect of Probiotic Supplementation on Depressive Symptoms and Quality of Life in Patients After Myocardial Infarction: Results of a Preliminary Double-Blind Clinical Trial.,"OBJECTIVE


Evidence indicates that probiotic supplements may improve or prevent depression. Little is known about the effects of probiotic supplementation on symptoms of depression and quality of life (QOL) in patients with myocardial infarction (MI).
METHODS


This randomized, double-blind, and placebo-controlled clinical trial was performed in 44 patients with a recent diagnosis of MI who underwent percutaneous coronary intervention. Patients were randomly assigned to receive either capsules containing 1.6 × 10 colony-forming units of Lactobacillus rhamnosus capsules with their lunch (the active intervention group) or capsules that contained maltodextrin (the placebo control group) for 12 weeks. The Beck Depression Inventory, QOL, and biomarkers of oxidative stress (serum total antioxidant capacity), and malondialdehyde), and high-sensitivity C-reactive protein (hs-CRP) as inflammation marker were assessed. These measures were obtained at baseline and at 12 weeks' follow-up.
RESULTS


The total Beck Depression Inventory score decreased significantly in patients who received probiotic supplements compared with the placebo group (-5.57 [6.1] versus -0.51 [2.8], p = .045). Improvements in the mean QOL score were also stronger in the probiotic versus the placebo group (23.6 [39.1] versus 0.44 [42.6], p = .023). In addition, increases in total antioxidant capacity (93.7 [88.4] versus 27.54 [64.7] mmol/l, p = .009) and decreases in malondialdehyde (-40.7 [63.73] versus -4.2 [67.6] nmol/ml, p = .033) and high-sensitivity C-reactive protein (-1.74 [0.70] versus 0.67 [1.27] mg/l, p = .040) levels were stronger in patients receiving probiotic supplementation than the placebo group.
CONCLUSION


These data provide preliminary evidence that probiotic supplementation in patients with percutaneous coronary intervention post-MI has beneficial effects on depressive symptoms and markers of oxidative stress and inflammation. Multicenter studies with larger sample sizes are needed to replicate these findings and identify patient subgroups with the most benefit from probiotic supplementation.
TRIAL REGISTRATION


www.irct.ir identifier: IRCT20121028011288N15.",2019,"The total BDI score decreased significantly in patients who received probiotic supplements compared to the placebo group (-5.57±6.1 vs. -0.51±2.8, P=0.045).","['44 patients with a recent diagnosis of MI who underwent percutaneous coronary intervention (PCI', 'patients with PCI post-MI', 'patients with myocardial infarction (MI', 'Patients after Myocardial Infarction']","['placebo', 'Lactobacillus rhamnosus capsules 1.6 ×10 colony-forming unit (CFU) with their lunch (the active intervention group) or capsules that contained maltodextrin (the placebo', 'probiotic supplementation', 'Probiotics Supplementation']","['TAC', 'Beck Depression Inventory (BDI), QOL, and biomarkers of oxidative stress (serum total antioxidant capacity; TAC), and malondialdehyde; MDA) and high sensitivity C-reactive protein (hs-CRP) as inflammatory marker', 'Depressive Symptoms and Quality of Life', 'mean QOL score', 'MDA', 'symptoms of depression and quality of life (QOL', 'total BDI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0856742', 'cui_str': 'Post MI'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.575797,"The total BDI score decreased significantly in patients who received probiotic supplements compared to the placebo group (-5.57±6.1 vs. -0.51±2.8, P=0.045).","[{'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Moludi', 'Affiliation': 'From the School of Nutrition Sciences and Food Technology (Moludi), Kermanshah University of Medical Sciences, Kermanshah, Iran; Nutrition Research Center, Faculty of Nutrition (Alizadeh, Davari), Tabriz University of Medical Sciences, Tabriz, Iran; and Department of Cardiology, Shohada Hospital (Mohammadzad), Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': ''}, {'ForeName': 'Mir Hossein Seyed', 'Initials': 'MHS', 'LastName': 'Mohammadzad', 'Affiliation': ''}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davari', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000749']
3182,28454014,"Reduced mouse allergen is associated with epigenetic changes in regulatory genes, but not mouse sensitization, in asthmatic children.","Chronic exposure to mouse allergen may contribute greatly to the inner-city asthma burden. We hypothesized that reducing mouse allergen exposure may modulate the immunopathology underlying symptomatic pediatric allergic asthma, and that this occurs through epigenetic regulation. To test this hypothesis, we studied a cohort of mouse sensitized, persistent asthmatic inner-city children undergoing mouse allergen-targeted integrated pest management (IPM) vs education in a randomized controlled intervention trial. We found that decreasing mouse allergen exposure, but not cockroach, was associated with reduced FOXP3 buccal DNA promoter methylation, but this was unrelated to mouse specific IgE production. This finding suggests that the environmental epigenetic regulation of an immunomodulatory gene may occur following changing allergen exposures in some highly exposed cohorts. Given the clinical and public health importance of inner-city pediatric asthma and the potential impact of environmental interventions, further studies will be needed to corroborate changes in epigenetic regulation following changing exposures over time, and determine their impact on asthma morbidity in susceptible children.",2017,"We found that decreasing mouse allergen exposure, but not cockroach, was associated with reduced FOXP3 buccal DNA promoter methylation, but this was unrelated to mouse specific IgE production.","['cohort of mouse sensitized, persistent asthmatic inner-city children undergoing', 'susceptible children', 'asthmatic children']",['mouse allergen-targeted integrated pest management (IPM) vs education'],['FOXP3 buccal DNA promoter methylation'],"[{'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}]","[{'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0031249', 'cui_str': 'Pest Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}]",,0.108617,"We found that decreasing mouse allergen exposure, but not cockroach, was associated with reduced FOXP3 buccal DNA promoter methylation, but this was unrelated to mouse specific IgE production.","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Miller', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Columbia University Medical Center, PH8E-101B, 630 W. 168th St., New York City, NY 10032, USA; Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Columbia University Medical Center, PH8E-101B, 630 W. 168th St., New York City, NY 10032, USA; Department of Environmental Health Sciences, Columbia University, 722 W 168th St, 11th Floor, New York City, NY, 10032, USA. Electronic address: rlm14@cumc.columbia.edu.'}, {'ForeName': 'Hanjie', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Columbia University Medical Center, PH8E-101B, 630 W. 168th St., New York City, NY 10032, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jezioro', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Columbia University Medical Center, PH8E-101B, 630 W. 168th St., New York City, NY 10032, USA.'}, {'ForeName': 'Mariangels', 'Initials': 'M', 'LastName': 'De Planell Saguer', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Columbia University Medical Center, PH8E-101B, 630 W. 168th St., New York City, NY 10032, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lovinsky-Desir', 'Affiliation': 'Division of Pulmonary, Department of Pediatrics, Columbia University Medical Center, 3959 Broadway, CHC 7-701, New York City, NY 10032, USA.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Columbia University Medical Center, 722 W 168 St, 6 Floor, New York City, NY, 10032, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Perzanowski', 'Affiliation': 'Department of Environmental Health Sciences, Columbia University, 722 W 168th St, 11th Floor, New York City, NY, 10032, USA.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Divjan', 'Affiliation': 'Department of Environmental Health Sciences, Columbia University, 722 W 168th St, 11th Floor, New York City, NY, 10032, USA.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Pediatric Allergy/Immunology, Boston Children's Hospital, Harvard Medical School, 300 Longwood Ave, Boston, MA 02115, USA.""}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Matsui', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins School of Medicine, CMSC 1102, 600 N. Wolfe Street, Baltimore, MD 21287, USA.'}]",Environmental research,['10.1016/j.envres.2017.04.025']
3183,31573608,Alendronate Improves Bone Mineral Density in Children and Adolescents Perinatally Infected With Human Immunodeficiency Virus With Low Bone Mineral Density for Age.,"BACKGROUND


Children and adolescents with perinatal human immunodeficiency virus (HIV) infection and with low bone mineral density (BMD) may be at higher risk of osteoporosis and fractures in later life than their uninfected peers. Bisphosphonate therapy has been shown to reduce fractures in adults with osteoporosis, but has not been formally studied in youths living with HIV.
METHODS


Fifty-two children and adolescents (aged 11-24 years) perinatally infected with HIV with low lumbar spine (LS) BMD (Z score < -1.5) were randomized to receive once-weekly alendronate or placebo in a double-blind cross-over study designed to assess the safety and efficacy of 48 and 96 weeks of alendronate in the United States and Brazil. All participants received daily calcium carbonate and vitamin D supplementation and were asked to engage in regular weight-bearing exercise. Safety and efficacy are summarized for the initial 48 weeks of the trial.
RESULTS


Grade 3 or higher abnormal laboratory values, signs, or symptoms developed in 5 of 32 (16%) participants on alendronate and 2 of 18 (11%) on placebo (P > .99). No cases of jaw osteonecrosis, atrial fibrillation, or nonhealing fractures were reported. Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate (20% [14%-25%]) than placebo (7% [5%-9%]) (P < .001). Similar improvements were seen for whole body BMD.
CONCLUSIONS


In this small study in children and adolescents perinatally infected with HIV with low LS BMD, 48 weeks of alendronate was well-tolerated, showed no safety concerns, and significantly improved LS and whole body BMD compared to participants on vitamin D/calcium supplementation and exercise alone.
CLINICAL TRIALS REGISTRATION


NCT00921557.",2020,"Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate [20% (14%, 25%)] than placebo [7% (5%, 9%), p<0.001].","['Fifty-two PHIV', 'adults with osteoporosis', 'Perinatally HIV-infected (PHIV) children and adolescents with low bone mineral density (BMD', 'perinatally HIV-infected children and adolescents with low bone mineral density for age', '11-<25 years of age with low lumbar spine (LS) BMD (Z-score < -1.5', 'PHIV children and adolescents with low LS BMD']","['Alendronate', 'alendronate or placebo', 'placebo', 'daily calcium carbonate and vitamin D supplementation', 'Bisphosphonate therapy', 'alendronate']","['LS and whole body BMD', 'Safety and efficacy', 'jaw osteonecrosis, atrial fibrillation, or non-healing fractures', 'LS BMD', 'bone mineral density', 'safety and efficacy']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C4510264', 'cui_str': 'Disphosphonate therapy'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.437437,"Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate [20% (14%, 25%)] than placebo [7% (5%, 9%), p<0.001].","[{'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Jacobson', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Lindsey', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Hazra', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Division of Extramural Research, Department of Health and Human Services, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Kelly Government Solutions, contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Ferreira', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fabiana R', 'Initials': 'FR', 'LastName': 'Amaral', 'Affiliation': 'Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jesica', 'Initials': 'J', 'LastName': 'Pagano-Therrien', 'Affiliation': 'Graduate School of Nursing, University of Massachusetts, Worcester, Massachusetts, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Gaur', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, Tennessee, USA.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Family Health International 360, Durham, North Carolina, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Benson', 'Affiliation': 'Department of Radiology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'Office of HIV/AIDS, US Agency for International Development, Arlington, Virginia, USA; for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1076 Study Team.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz957']
3184,29053185,Expression of the DNA repair gene MLH1 correlates with survival in patients who have resected pancreatic cancer and have received adjuvant chemoradiation: NRG Oncology RTOG Study 9704.,"BACKGROUND


The majority of patients with pancreatic cancer who undergo curative resection experience rapid disease recurrence. In previous small studies, high expression of the mismatch-repair protein mutL protein homolog 1 (MLH1) in pancreatic cancers was associated with better outcomes. The objective of this study was to validate the association between MLH1 expression and survival in patients who underwent resection of pancreatic cancer and received adjuvant chemoradiation.
METHODS


Samples were obtained from the NRG Oncology Radiation Therapy Oncology Group 9704 prospective, randomized trial (clinicaltrials.gov identifier NCT00003216), which compared 2 adjuvant protocols in patients with pancreatic cancer who underwent resection. Tissue microarrays were prepared from formalin-fixed, paraffin-embedded, resected tumor tissues. MLH1 expression was quantified using fluorescence immunohistochemistry and automated quantitative analysis, and expression was dichotomized above and below the median value.
RESULTS


Immunohistochemical staining was successfully performed on 117 patients for MLH1 (60 and 57 patients from the 2 arms). The characteristics of the participants who had tissue samples available were similar to those of the trial population as a whole. At the time of analysis, 84% of participants had died, with a median survival of 17 months. Elevated MLH1 expression levels in tumor nuclei were significantly correlated with longer disease-free and overall survival in each arm individually and in both arms combined. Two-year overall survival was 16% in patients who had low MLH1 expression levels and 53% in those who had high MLH1 expression levels (P < .0001 for both arms combined). This association remained true on a multivariate analysis that allowed for lymph node status (hazard ratio, 0.41; 95% confidence interval, 0.27-0.63; P < .0001).
CONCLUSIONS


In the current sample, MLH1 expression was correlated with long-term survival. Further studies should assess whether MLH1 expression predicts which patients with localized pancreatic cancer may benefit most from aggressive, multimodality treatment. Cancer 2018;124:491-8. © 2017 American Cancer Society.",2018,Elevated MLH1 expression levels in tumor nuclei were significantly correlated with longer disease-free and overall survival in each arm individually and in both arms combined.,"['© 2017 American Cancer Society', 'patients with pancreatic cancer who underwent resection', 'patients who have resected pancreatic cancer and have received adjuvant chemoradiation: NRG Oncology RTOG Study 9704', 'patients who underwent resection of pancreatic cancer and received adjuvant chemoradiation', 'patients with localized pancreatic cancer', 'patients with pancreatic cancer who undergo curative resection experience rapid disease recurrence', 'participants who had tissue samples available were similar to those of the trial population as a whole', '117 patients for MLH1 (60 and 57 patients from the 2 arms']",[],"['high MLH1 expression levels', 'median survival', 'Elevated MLH1 expression levels', 'MLH1 expression', 'MLH1 expression and survival', 'overall survival']","[{'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",117.0,0.184993,Elevated MLH1 expression levels in tumor nuclei were significantly correlated with longer disease-free and overall survival in each arm individually and in both arms combined.,"[{'ForeName': 'Yaacov R', 'Initials': 'YR', 'LastName': 'Lawrence', 'Affiliation': 'Department of Oncology, Chaim Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, Tel HaShomer, Israel.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Moughan', 'Affiliation': 'Statistics and Data Management Center, NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Magliocco', 'Affiliation': 'Department of Anatomic Pathology, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Klimowicz', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Regine', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Rex B', 'Initials': 'RB', 'LastName': 'Mowat', 'Affiliation': 'Toledo Clinic Cancer Centers, Toledo, Ohio.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'DiPetrillo', 'Affiliation': 'Department of Radiation Oncology, Rhode Island Hospital/The Warren Alpert Medical School of Brown University, Providence, Rhode, Island.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': 'Department of Radiation Oncology, Loyola University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jeffry P', 'Initials': 'JP', 'LastName': 'Simko', 'Affiliation': 'Department of Pathology, University of California-San Francisco Medical Center, San Francisco, California.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Golan', 'Affiliation': 'Department of Oncology, Chaim Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, Tel HaShomer, Israel.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Winter', 'Affiliation': 'Statistics and Data Management Center, NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Guha', 'Affiliation': 'Department of Radiation Oncology, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Crane', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Dicker', 'Affiliation': 'Department of Radiation Oncology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.'}]",Cancer,['10.1002/cncr.31058']
3185,30724002,"The effects of licogliflozin, a dual SGLT1/2 inhibitor, on body weight in obese patients with or without diabetes.","BACKGROUND


There is an unmet need for a safer and more effective treatment for obesity. This study assessed the effects of licogliflozin, a dual inhibitor of sodium-glucose co-transporter (SGLT) 1/2, on body weight, metabolic parameters and incretin hormones in patients with type 2 diabetes mellitus (T2DM) and/or obesity.
METHODS


Patients with obesity (BMI, 35-50 kg/m 2  ) were enrolled into a 12-week study (N = 88; licogliflozin 150 mg q.d.). Patients with T2DM were enrolled into a second, two-part study, comprising a single-dose cross-over study (N = 12; 2.5 - 300 mg) and a 14-day dosing study (N = 30; 15 mg q.d). Primary endpoints included effects on body weight, effects on glucose, safety and tolerability. Secondary endpoints included urinary glucose excretion (UGE 24  ) and pharmacokinetics, while exploratory endpoints assessed the effects on incretin hormones (total GLP-1, PYY 3-36  , and GIP), insulin and glucagon.
RESULTS


Treatment with licogliflozin 150 mg q.d. for 12 weeks in patients with obesity significantly reduced body weight by 5.7% vs placebo (P < 0.001) and improved metabolic parameters such as significantly reduced postprandial glucose excursion (21%; P < 0.001), reduced insulin levels (80%; P < 0.001) and increased glucagon (59%; P < 0.001). In patients with T2DM, a single dose of licogliflozin 300 mg in the morning prior to an oral glucose tolerance test (OGTT) remarkably reduced glucose excursion by 93% (P < 0.001; incremental AUC 0-4h  ) and suppressed insulin by 90% (P < 0.01; incremental AUC 0-4h  ). Treatment with licogliflozin 15 mg q.d. for 14 days reduced 24-hour average glucose levels by 26% (41 mg/dL; P < 0.001) and increased UGE 24  to 100 g (P < 0.001) in patients with T2DM. In addition, this treatment regimen significantly increased total GLP-1 by 54% (P < 0.001) and PYY 3-36  by 67% (P < 0.05) post OGTT vs placebo, while significantly reducing GIP levels by 53% (P < 0.001). Treatment with licogliflozin was generally safe and well tolerated. Diarrhea (increased numbers of loose stool) was the most common adverse event in all studies (90% with licogliflozin vs 25% with placebo in the 12-week study), while a lower incidence of flatulence, abdominal pain and abdominal distension (25%-43% with licogliflozin vs 9%-11% with placebo in the 12-week study) were among the other gastrointestinal events reported.
CONCLUSION


Licogliflozin treatment (1-84 days) leads to significant weight loss and favourable changes in a variety of metabolic parameters and incretin hormones. Dual inhibition of SGLT1/2 with licogliflozin in the gut and kidneys is an attractive strategy for treating obesity and diabetes.",2019,"In addition, this treatment regimen significantly increased total GLP-1 by 54% (P < 0.001) and PYY 3-36  by 67% (P < 0.05) post OGTT vs placebo, while significantly reducing GIP levels by 53% (P < 0.001).","['patients with type 2 diabetes mellitus (T2DM) and/or obesity', 'Patients with obesity (BMI, 35-50\u2009kg/m 2  ', 'Patients with T2DM', 'obese patients with or without diabetes']","['placebo', 'SGLT1/2 with licogliflozin', 'licogliflozin, a dual inhibitor of sodium-glucose co-transporter (SGLT', 'licogliflozin', 'Licogliflozin']","['total GLP-1', 'safe and well tolerated', 'urinary glucose excretion (UGE 24  ) and pharmacokinetics, while exploratory endpoints assessed the effects on incretin hormones (total GLP-1, PYY 3-36  , and GIP), insulin and glucagon', 'postprandial glucose excursion', 'reduced insulin levels', 'GIP levels', 'Diarrhea', 'weight loss', '24-hour average glucose levels', 'flatulence, abdominal pain and abdominal distension', 'body weight, metabolic parameters and incretin hormones', 'body weight, effects on glucose, safety and tolerability', 'glucose excursion', 'glucagon', 'body weight', 'metabolic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0312349,"In addition, this treatment regimen significantly increased total GLP-1 by 54% (P < 0.001) and PYY 3-36  by 67% (P < 0.05) post OGTT vs placebo, while significantly reducing GIP levels by 53% (P < 0.001).","[{'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'He', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haynes', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Meyers', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Amer', 'Affiliation': 'CMO and Patient Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Early Development Biostatistics, Biostatistics and Pharmacometrics, Novartis Institutes for BioMedical Research, East Hanover, New Jersey.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Mahling', 'Affiliation': 'DEV B&SS, CM/Global Health, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Anisha E', 'Initials': 'AE', 'LastName': 'Mendonza', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chutkow', 'Affiliation': 'Cardiovascular and Metabolism Disease Area, Novartis Institutes for BioMedical Research, Cambridge, Massachussets.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bachman', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13654']
3186,31903494,Evaluating the Effects of a Brief Tobacco Intervention in the US Air Force.,"INTRODUCTION


Military personnel have among the highest rates of tobacco use in the United States. Unfortunately, there are few interventions aimed at reducing tobacco use among this vulnerable population. The current study addresses this need by evaluating the short-term effectiveness of a Brief Tobacco Intervention (BTI), a 40-min group-based intervention designed to reduce contemporary patterns of tobacco use among a sample of US military enlistees during an 11-week period of involuntary tobacco abstinence.
AIMS AND METHODS


Participants were 2999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018. Participants were cluster randomized to three conditions: (1) BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention. The primary analysis was a comparison of the interventions' efficacies in preventing tobacco use during Technical Training, conducted using a generalized estimating equations logistic regression model controlling for covariates. Multiple imputation was used to account for loss to follow-up.
RESULTS


There was not a significant difference by condition in the use of tobacco products at follow-up (p = .454). The BTI + AG condition did produce short-term changes in perceived harm, intentions to use tobacco, knowledge about tobacco products, and normative beliefs.
CONCLUSIONS


These findings suggest that while the intervention was effective in the short term, it was not potent enough over a 12-week period to prevent Airmen from initiating tobacco use. Future studies should examine whether adding a booster session or media campaign enhances the effectiveness of the intervention.
IMPLICATIONS


Despite the fact that most Airmen believe they will remain tobacco free following the ban in Technical Training, a large percentage of these Airmen resume and initiate tobacco use during this high-risk period. As a result, there is a need for interventions targeting the range of tobacco available to military trainees during a teachable moment when they report intentions to remain tobacco free. The current study shows that a BTI has promise in reducing long-term tobacco use, when coupled with additional interventions, such as a booster session or a media campaign.",2020,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"['Participants were 2,999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018']","['Brief Tobacco Intervention (BTI', 'Brief Tobacco Intervention', ""BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention""]",[],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],,0.0315383,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McMurry', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Gerald W', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa001']
3187,31291447,Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity.,"BACKGROUND


Different fatty acids (FAs) can vary in their obesogenic effect, and genetic makeup can contribute to fat deposition in response to dietary FA composition. However, the antiobesogenic effects of the interactions between dietary MUFAs and genetics have scarcely been tested in intervention studies.
OBJECTIVE


We evaluated the overall (primary outcome) and genetically modulated (secondary outcome) response in body weight and fat mass to different levels of MUFA consumption.
METHODS


In the Canola Oil Multicenter Intervention Trial II, a randomized, crossover, isocaloric, controlled-feeding multicenter trial, 44 men and 71 women with a mean age of 44 y and an increased waist circumference (men ∼108 cm and women ∼102 cm) consumed each of 3 oils for 6 wk, separated by four 12-wk washout periods. Oils included 2 high-MUFA oils-conventional canola and high-oleic canola (<7% SFAs, >65% MUFAs)-and 1 low-MUFA/high-SFA oil blend (40.2% SFAs, 22.0% MUFAs). Body fat was measured using DXA. Five candidate single-nucleotide polymorphisms (SNPs) were genotyped using qualitative PCR. Data were analyzed using a repeated measures mixed model.
RESULTS


No significant differences were observed in adiposity measures following the consumption of either high-MUFA diet compared with the low-MUFA/high-SFA treatment. However, when stratified by genotype, 3 SNPs within lipoprotein lipase (LPL), adiponectin, and apoE genes influenced, separately, fat mass changes in response to treatment (n = 101). Mainly, the LPL rs13702-CC genotype was associated with lower visceral fat (high-MUFA: -216.2 ± 58.6 g; low-MUFA: 17.2 ± 81.1 g; P = 0.017) and android fat mass (high-MUFA: -267.3 ± 76.4 g; low-MUFA: -21.7 ± 102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets.
CONCLUSIONS


Common variants in LPL, adiponectin, and apoE genes modulated body fat mass response to dietary MUFAs in an isocaloric diet in adults with abdominal obesity. These findings might eventually help in developing personalized dietary recommendations for weight control. The trial was registered at clinicaltrials.gov as NCT02029833 (https://www.clinicaltrials.gov/ct2/show/NCT02029833?cond=NCT02029833&rank=1).",2019,"102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets.
","['adults with abdominal obesity', 'Adults with Abdominal Obesity', '44 men and 71 women with a mean age of 44 y and an increased waist circumference (men ∼108 cm and women ∼102 cm']","['MUFA oils-conventional canola and high-oleic canola', 'Dietary Monounsaturated Fatty Acids']","['adiposity measures', 'Body fat', 'body weight and fat mass to different levels of MUFA consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",44.0,0.0925839,"102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets.
","[{'ForeName': 'Shatha S', 'Initials': 'SS', 'LastName': 'Hammad', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eck', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Sihag', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Connelly', 'Affiliation': ""Keenan Research Centre for Biomedical Science of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Lamarche', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Couture', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Guay', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Maltais-Giguère', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Sheila G', 'Initials': 'SG', 'LastName': 'West', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kate J', 'Initials': 'KJ', 'LastName': 'Bowen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'David J A', 'Initials': 'DJA', 'LastName': 'Jenkins', 'Affiliation': ""Keenan Research Centre for Biomedical Science of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Carla G', 'Initials': 'CG', 'LastName': 'Taylor', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Perera', 'Affiliation': 'Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Castillo', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zahradka', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter J H', 'Initials': 'PJH', 'LastName': 'Jones', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz136']
3188,31187454,"Long-Term Neuropsychological Outcomes from an Open-Label Phase I/IIa Trial of 2-Hydroxypropyl-β-Cyclodextrins (VTS-270) in Niemann-Pick Disease, Type C1.","BACKGROUND


Niemann-Pick disease, type C1 (NPC1) is a neurodegenerative condition that arises from mutations of NPC1 and is often diagnosed in children. Recently, several drug trials have been implemented to minimize neurodegeneration, including a trial of 2-hydroxypropyl-β-cyclodextrins (VTS-270).
OBJECTIVES


The current study extends findings from a previous report of 18 months of disease severity data by describing neuropsychological outcomes over the course of 36 months post-baseline.
DESIGN


An open-label, dose-escalation phase I/IIa study of VTS-270 was performed in participants with NPC1 aged 4-23 years.
METHODS


Fourteen participants were sequentially assigned to receive monthly initial intrathecal VTS-270 at doses of 50, 200, 300, or 400 mg per month. After initial dosing, participants were dose-escalated (to 600 or 1200 mg) as tolerated. Participants were evaluated at 6-month intervals using a standardized neuropsychological battery, including tests of cognition and adaptive behavior. A random effects model with restricted maximum likelihood estimation was constructed for each outcome, and the slope was the parameter of interest.
RESULTS


Findings based on IQ scores and both standard scores and age equivalents of adaptive functioning indicate that there were not meaningful declines in these areas during the study period. The average annualized change in Full Scale IQ was negative: B = - 1.28, standard error (SE) = 0.70, t(34.2) = - 1.83, p = 0.076. The Vineland-II Adaptive Behavior Composite standard score decreased by 1.76 points per year [SE = 0.67, t(59.1) = - 2.62, p = 0.011], but annualized slopes for each of the domain age equivalents were positive: Communication [B = 0.71, SE = 3.12, t(60.7) = 0.23, p = 0.82], Socialization [B = 2.99, SE = 2.92, t(60.4) = 1.03, p = 0.30], Daily Living Skills [B = 2.76, SE = 2.76, t(60.3) = 1.18, p = 0.24], and Motor Skills [B = 1.42, SE = 0.94, t(50.5) = 1.51, p = 0.14], indicating not worsening but slower-than-average acquisition of skills.
CONCLUSION


In conjunction with previous findings, these results provide support for the slowing of disease progress up to 36 months post-initiation of intrathecal VTS-270.
REGISTRATION


ClinicalTrials.gov identifier NCT01747135: Hydroxypropyl Beta Cyclodextrin for Niemann-Pick type C1 Disease.",2019,"The Vineland-II Adaptive Behavior Composite standard score decreased by 1.76 points per year [SE = 0.67, t(59.1) = - 2.62, p = 0.011], but annualized slopes for each of the domain age equivalents were positive: Communication [B = 0.71, SE = 3.12, t(60.7) = 0.23,","['participants with NPC1 aged 4-23\xa0years', 'Niemann-Pick type C1 Disease', 'Fourteen participants']","['VTS-270', '2-Hydroxypropyl-β-Cyclodextrins (VTS-270', 'initial intrathecal VTS-270', 'Hydroxypropyl Beta Cyclodextrin']","['tolerated', 'Motor Skills', 'Vineland-II Adaptive Behavior Composite standard score', 'Full Scale IQ', 'Daily Living Skills']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0046237', 'cui_str': 'hydroxypropyl betadex'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",14.0,0.0744824,"The Vineland-II Adaptive Behavior Composite standard score decreased by 1.76 points per year [SE = 0.67, t(59.1) = - 2.62, p = 0.011], but annualized slopes for each of the domain age equivalents were positive: Communication [B = 0.71, SE = 3.12, t(60.7) = 0.23,","[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Thurm', 'Affiliation': 'Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Farhat', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bianconi', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Lee Ann', 'Initials': 'LA', 'LastName': 'Keener', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Forbes D', 'Initials': 'FD', 'LastName': 'Porter', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA. fdporter@mail.nih.gov.'}]",CNS drugs,['10.1007/s40263-019-00642-2']
3189,31268224,A person-centered education for adolescents with type 1 diabetes-A randomized controlled trial.,"INTRODUCTION


Young people with type 1 diabetes and their parents need to receive person-centered education to be able to manage their diabetes. Guided Self-Determination-Young (GSD-Y) is a person-centered communication and reflection education model that can be used in educational program for young people with type 1 diabetes.
OBJECTIVE


To evaluate whether GSD-Y leads to improved glycaemic control, increased self-perceived health and health-related quality of life, fewer diabetes-related family conflicts, and improved self-efficacy in a group-based intervention for adolescents starting continuous subcutaneous insulin infusion (CSII) and their parents.
METHODS


This randomized controlled trial included 71 adolescents starting CSII. Participants were followed for 12 months. The intervention group (n = 37) attended seven group training sessions over a period of 5 months, using the GSD-Y model, the control group received standard care. Variables evaluated were HbA1c, self-perceived health, health-related quality of life, family conflicts, self-efficacy, and usage of continuous glucose monitoring.
RESULTS


When adjusted for sex and family conflicts, there was a difference in glycaemic control between the groups at 12 months, favoring the intervention group (62 vs 70 mmol/mol, P = .009). When analyses were performed on boys and girls separately and adjusted for family conflicts, the only difference detected was for boys after 12 months (P = .019). The intervention showed no effect on self-perceived health, health-related related quality of life, family conflicts, or self-efficacy.
CONCLUSIONS


An intervention with GSD-Y may have an effect on glycaemic control. The content of the GSD-Y groups may serve as a model for person-centered care in adolescents with type 1 diabetes.",2019,"Guided Self-Determination-Young (GSD-Y) is a person-centred communication and reflection education model that can be used in educational programmes for young people with type 1 diabetes.
","['adolescents starting continuous subcutaneous insulin infusion (CSII) and their parents', 'adolescents with type 1 diabetes', 'young people with type 1 diabetes', '71 adolescents starting CSII', 'Young people with type 1 diabetes']","['control group received standard care', 'Guided Self-Determination-Young (GSD-Y']","['glycaemic control', 'self-perceived health, health-related related quality of life, family conflicts, or self-efficacy', 'HbA1c, self-perceived health, health-related quality of life, family conflicts, self-efficacy, and usage of continuous glucose monitoring', 'glycaemic control, increased self-perceived health and health-related quality of life, fewer diabetes-related family conflicts, and improved self-efficacy']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0233542', 'cui_str': 'Family conflict (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",71.0,0.0499828,"Guided Self-Determination-Young (GSD-Y) is a person-centred communication and reflection education model that can be used in educational programmes for young people with type 1 diabetes.
","[{'ForeName': 'Anna Lena', 'Initials': 'AL', 'LastName': 'Brorsson', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Janeth', 'Initials': 'J', 'LastName': 'Leksell', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Andersson Franko', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lindholm Olinder', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}]",Pediatric diabetes,['10.1111/pedi.12888']
3190,30663569,Effect of Early Normotension with Olmesartan on Rho-kinase Activity in Hypertensive Patients.,"BACKGROUND


Angiotensin II is a potent activator of the Rho-kinase (ROCK) pathway, through which it exerts some of its adverse vasoconstrictor effects. Clinical evidence on the effects of blocking the angiotensin II receptor 1 on ROCK activity in hypertensive patients is scarce.
OBJECTIVE


To demonstrate that ROCK activity in peripheral blood mononuclear cells (PMBCs) in patients with essential hypertension is reduced earlier than previously observed, along with blood pressure (BP) lowering on treatment with olmesartan.
METHODS


Prospective pilot open study; 17 hypertensive patients were treated with progressive olmesartan doses starting with 20 mg qd. BP was measured at 3, 6 and 9 weeks after treatment initiation. If treatment failed to normalize BP after 3 weeks, olmesartan dose was increased to 40 mg qd, and if still hypertensive after 6 weeks, 12.5 mg of hydrochlorothiazide qd was added. ROCK activity was measured at baseline and 9 weeks after treatment as myosin phosphatase target subunit 1 phosphorylation (MYPT1-p/T ratio) in PBMC.
RESULTS


Mean baseline BP was 162 ± 4.9/101 ± 2.4 mmHg. After 9 weeks of treatment, both systolic and diastolic BP were reduced by 41 and 22 mmHg, respectively (p<0.05). Mean pretreatment MYPT1- p/T ratio in PMBCs was significantly reduced by 80% after 9 weeks with olmesartan (p<0.01).
CONCLUSION


Normotension achieved after 9 weeks in 82% of the patients treated with olmesartan was associated with a significant reduction of ROCK activity in PBMC.",2020,"Mean pretreatment MYPT1-p/T ratio in PBMC was significantly reduced by 80% after 9 weeks with olmesartan (p<0.01).
","['Hypertensive Patients', 'hypertensive patients', '17 hypertensive patients', 'patients with essential hypertension']","['progressive olmesartan doses starting with 20 mg qd', 'olmesartan', 'hydrochlorothiazide', 'Olmesartan']","['ROCK activity', 'Mean pretreatment MYPT1-p/T ratio in PBMC', 'BP', 'blood pressure (BP) lowering', 'systolic and diastolic BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1098320', 'cui_str': 'olmesartan'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",17.0,0.0230629,"Mean pretreatment MYPT1-p/T ratio in PBMC was significantly reduced by 80% after 9 weeks with olmesartan (p<0.01).
","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cantin', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Jalil', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Bulnes', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}, {'ForeName': 'Ulises', 'Initials': 'U', 'LastName': 'Novoa', 'Affiliation': 'Universidad de Talca, Facultad de Ciencias de la Salud, Department of Biomedical Sciences, Talca, Chile.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'MacNab', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Godoy', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Córdova', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Gabrielli', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}, {'ForeName': 'María Paz', 'Initials': 'MP', 'LastName': 'Ocaranza', 'Affiliation': 'Pontificia Universidad Catolica de Chile, School of Medicine, Division of Cardiovascular Diseases, Santiago, Chile.'}]",Current vascular pharmacology,['10.2174/1570161117666190121103116']
3191,31972667,Antidepressant Effect of Adjunct Repetitive Transcranial Magnetic Stimulation in Inpatients 60 Years and Older.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) is now an established, safe, and effective treatment for adults with depression. However, specific research in rTMS for use in elderly patients with acute depression is scarce.
OBJECTIVE


The aim of the present study was to investigate the efficacy of add-on rTMS in a clinical sample of older adults experiencing an acute phase of depression.
METHOD


This study examined 114 patients (54 elderly [aged ≥60] and 60 adults [aged 18-59]) with acute depression who were drug free at baseline. They were treated with at least 10 sessions of rTMS for 4 weeks along with 1 antidepressant. Symptoms of depression were measured using the Hamilton Rating Scale for Depression at baseline and after 2 and 4 weeks of treatment. Clinical improvement and rates of response and remission were compared across groups.
RESULTS


Significant improvement was noted after 2 and 4 weeks of treatment in both adult and elderly groups. Higher remission rates were found in adult patients but with no differences in response. The stimulation intensity and course of illness were significant predictors of remission after 4 weeks of rTMS treatment in the elderly.
CONCLUSIONS


The add-on rTMS treatment for elderly depression patients is promising with respect to safety and feasibility. This preliminary evidence supports the application of rTMS to this group during acute episodes.",2020,"The stimulation intensity and course of illness were significant predictors of remission after 4 weeks of rTMS treatment in the elderly.
","['114 patients (54 elderly [aged ≥60] and 60 adults [aged 18-59]) with acute depression who were drug free at baseline', 'Inpatients 60 Years and Older', 'older adults experiencing an acute phase of depression', 'elderly depression patients', 'adults with depression', 'elderly patients with acute depression']","['Repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Adjunct Repetitive Transcranial Magnetic Stimulation']","['Symptoms of depression', 'Hamilton Rating Scale for Depression', 'stimulation intensity and course of illness', 'Clinical improvement and rates of response and remission', 'Higher remission rates']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1386135', 'cui_str': 'Acute depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",114.0,0.036166,"The stimulation intensity and course of illness were significant predictors of remission after 4 weeks of rTMS treatment in the elderly.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'JunJie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'JunJuan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'HuiRu', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'YingYing', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'LiHua', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'XiaoChen', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'YanYan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hui', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'ChunBo', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'QiuFang', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'HongLiang', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wen', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'JiJun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'TianHong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}]",The journal of ECT,['10.1097/YCT.0000000000000648']
3192,31667935,Repetitive Peripheral Magnetic Stimulation for Strengthening of the Suprahyoid Muscles: A Randomized Controlled Trial.,"OBJECTIVE


Head lift exercise is a widely known form of training in the rehabilitation of patients with dysphagia. This study aimed to compare muscular strength reinforcement training of the suprahyoid muscles using repetitive peripheral magnetic stimulation (rPMS) with head lift exercises in a randomized controlled trial.
MATERIALS AND METHODS


Twenty-four healthy adults were randomly assigned to either the magnetic stimulation group (M group) or the head lift exercise group (H group). Both groups underwent training five days a week for two weeks. The primary outcome was the cervical flexor strength, and secondary outcomes were jaw-opening force, tongue pressure, muscle fatigue of the hyoid and laryngeal muscles, displacement of the hyoid bone and opening width of the upper esophageal sphincter (UES) while swallowing 10 mL of liquid, training performance rate, and pain.
RESULTS


No dropouts were reported during the two-week intervention period. Cervical flexor strength significantly increased solely in the M group. Tongue pressure significantly improved in both groups. There were no significant differences in the jaw-opening force, median frequency rate of the anterior belly of the digastric muscle, sternohyoid muscle, sternocleidomastoid muscle, anterior and superior hyoid bone displacement, and UES opening width in both groups.
CONCLUSIONS


Two-week rPMS of the suprahyoid muscles increased the strength of these muscles compared with the head lift exercise during the same period.",2020,"There were no significant differences in the jaw-opening force, median frequency rate of the anterior belly of the digastric muscle, sternohyoid muscle, sternocleidomastoid muscle, anterior and superior hyoid bone displacement, and UES opening width in both groups.
","['Suprahyoid Muscles', 'patients with dysphagia', 'Twenty-four healthy adults']","['muscular strength reinforcement training', 'head lift exercise', 'Head lift exercise', 'magnetic stimulation group (M group) or the head lift exercise', 'Repetitive Peripheral Magnetic Stimulation', 'repetitive peripheral magnetic stimulation (rPMS) with head lift exercises']","['jaw-opening force, median frequency rate of the anterior belly of the digastric muscle, sternohyoid muscle, sternocleidomastoid muscle, anterior and superior hyoid bone displacement, and UES opening width', 'Cervical flexor strength', 'cervical flexor strength, and secondary outcomes were jaw-opening force, tongue pressure, muscle fatigue of the hyoid and laryngeal muscles, displacement of the hyoid bone and opening width of the upper esophageal sphincter (UES) while swallowing 10 mL of liquid, training performance rate, and pain', 'Tongue pressure']","[{'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0224155', 'cui_str': 'Digastric muscle structure'}, {'cui': 'C0224162', 'cui_str': 'Structure of sternohyoid muscle'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0020417', 'cui_str': 'Lingual Bone'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}, {'cui': 'C0023054', 'cui_str': 'Laryngeal Muscles'}, {'cui': 'C1451819', 'cui_str': 'Upper Esophageal Sphincter'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",24.0,0.05486,"There were no significant differences in the jaw-opening force, median frequency rate of the anterior belly of the digastric muscle, sternohyoid muscle, sternocleidomastoid muscle, anterior and superior hyoid bone displacement, and UES opening width in both groups.
","[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ogawa', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kagaya', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nagashima', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Shino', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Inamoto', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Aoyagi', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Fumi', 'Initials': 'F', 'LastName': 'Toda', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Ozeki', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Saitoh', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13057']
3193,31951279,Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study.,"OBJECTIVE


To investigate the long-term efficacy and safety of the IL-6 receptor antibody tocilizumab in patients with Takayasu arteritis (TAK).
METHODS


Patients completing the randomized, double-blind, placebo-controlled period of the TAKT (Takayasu arteritis Treated with Tocilizumab) trial were followed up during open-label extended treatment with weekly s.c. tocilizumab 162 mg for up to 96 weeks or longer, with oral glucocorticoid tapering performed at the investigators' discretion. Endpoints of the extension analysis included steroid-sparing effects of tocilizumab, imaging data, patient-reported outcomes (36-Item Short Form Health Survey) and safety.
RESULTS


All 36 patients enrolled in the double-blind period entered the open-label extension; 28 patients received tocilizumab for 96 weeks. The median glucocorticoid dose was 0.223 mg/kg/day at the time of relapse before study entry, 0.131 mg/kg/day (interquartile range 0.099, 0.207) after 48 weeks and 0.105 mg/kg/day (interquartile range 0.039, 0.153) after 96 weeks. Overall, 46.4% of patients reduced their dose to <0.1 mg/kg/day, which was less than half the dose administered at relapse before study entry (mean difference -0.120 mg/kg/day; 95% CI -0.154, -0.087). Imaging evaluations indicated that most patients' disease was improved (17.9%) or stable (67.9%) after 96 weeks compared with baseline. Mean 36-Item Short Form Health Survey physical and mental component summary scores and 7 of 8 domain scores were clinically improved from baseline and maintained over 96 weeks of tocilizumab treatment. No unexpected safety issues were reported.
CONCLUSION


These results in patients with Takayasu arteritis provide evidence of a steroid-sparing effect and improvements in well-being during long-term treatment with once-weekly tocilizumab 162 mg, with no new safety concerns.
TRIAL REGISTRATION


JAPIC Clinical Trials Information, http://www.clinicaltrials.jp/user/cteSearch_e.jsp, JapicCTI-142616.",2020,Mean 36-Item Short Form Health Survey physical and mental component summary scores and 7 of 8 domain scores were clinically improved from baseline and maintained over 96 weeks of tocilizumab treatment.,"['refractory Takayasu arteritis', 'patients with Takayasu arteritis (TAK', '36 patients enrolled in the double-blind period entered the open-label extension; 28 patients received']","['Tocilizumab', 'tocilizumab', 'placebo-controlled period of the TAKT', 'IL-6 receptor antibody tocilizumab']","['Mean 36-Item Short Form Health Survey physical and mental component summary scores and 7 of 8 domain scores', 'steroid-sparing effects of tocilizumab, imaging data, patient-reported outcomes (36-Item Short Form Health Survey) and safety', 'median glucocorticoid dose']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0039263', 'cui_str': 'Takayasu Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.534507,Mean 36-Item Short Form Health Survey physical and mental component summary scores and 7 of 8 domain scores were clinically improved from baseline and maintained over 96 weeks of tocilizumab treatment.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Nakaoka', 'Affiliation': 'Department of Vascular Physiology, National Cerebral and Cardiovascular Center Research Institute, Suita Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Isobe', 'Affiliation': 'Sakakibara Heart Institute, Tokyo Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai Japan.'}, {'ForeName': 'Seido', 'Initials': 'S', 'LastName': 'Ooka', 'Affiliation': 'Division of Rheumatology and Allergology, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Niiro', 'Affiliation': 'Department of Medical Education, Faculty of Medical Sciences, Kyushu University, Fukuoka Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Tamura', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine, Tokyo Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Banno', 'Affiliation': 'Division of Nephrology and Rheumatology, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Yoshifuji', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto Kyoto, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawakami', 'Affiliation': 'Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Furuta', 'Affiliation': 'Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Ryoki', 'Initials': 'R', 'LastName': 'Hara', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Maejima', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Rheumatology, Shin-Kokura Hospital, Kitakyushu Japan.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Takasaki', 'Affiliation': 'Juntendo University Koshigaya Hospital, Juntendo University Faculty of Medicine, Saitama Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd, Tokyo Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd, Tokyo Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yamakido', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd, Tokyo Japan.'}, {'ForeName': 'Syuji', 'Initials': 'S', 'LastName': 'Takei', 'Affiliation': 'Pediatrics and Developmental Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima Japan.'}, {'ForeName': 'Shumpei', 'Initials': 'S', 'LastName': 'Yokota', 'Affiliation': 'Pediatric Rheumatology, Fuji Toranomon Orthopedics Hospital, Shizuoka, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Nishimoto', 'Affiliation': 'Department of Molecular Regulation for Intractable Diseases, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez630']
3194,31906801,Effects of Balance Training on Balance Performance in Youth: Are There Age Differences?,"Purpose : In youth, cross-sectional studies reported age differences in balance performance that were in favor of adolescents. Thus, trainability of balance performance might be different in children compared to adolescents. The purpose of this study was therefore to compare the effects of balance training (BT) on balance performance between children and adolescents. Method : Thirty children (7.5 ± 0.5 years) and 42 adolescents (14.7 ± 0.5 years) participated in this study and were assigned to either a BT-group or a control (CON) group. In both age groups, BT was conducted over five weeks while the CON-groups received their regular physical education lessons. Pre- and posttests included the assessment of mobility, static steady-state, proactive, and reactive balance. Results : Significant Test × Group × Age interactions were found for static steady-state balance (i.e., CoP displacements during single leg stance) and mobility (i.e., 10-m gait velocity). For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents. For proxies of proactive and reactive balance, we could not detect significant Test × Group × Age interactions. Conclusions : We conclude that trainability of static steady-state balance and mobility seems to be higher in children than in adolescents indicating larger adaptive reserves in children compared to adolescents. However, there were no age differences in adaptations to BT with respect to proactive and reactive balance.",2020,"For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents.","['Youth', 'Thirty children (7.5\xa0±\xa00.5\xa0years) and 42 adolescents (14.7\xa0±\xa00.5\xa0years', 'children and adolescents']","['Balance Training', 'balance training (BT', 'CON-groups received their regular physical education lessons', 'BT-group or a control (CON']","['assessment of mobility, static steady-state, proactive, and reactive balance', 'balance performance', 'static steady-state balance (i.e., CoP displacements', 'Balance Performance']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2317515', 'cui_str': 'Assessment of mobility (procedure)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}]",30.0,0.0210385,"For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schedler', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brock', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Fleischhauer', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiss', 'Affiliation': 'FHM Bielefeld - University of Applied Sciences.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muehlbauer', 'Affiliation': 'University of Duisburg-Essen.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1676371']
3195,31758887,Neonatal pain and heart rate variability in preterm infants treated with surfactant: a pilot study.,"OBJECTIVE


We aimed to assess the pain perception of preterm infants treated with different surfactant administration techniques by using heart rate variability (HRV).
METHODS


Preterm infants who required surfactant therapy for RDS were randomized to INSURE or MIST groups. HRV analysis was performed by Newborn Infant Parasympathetic Evaluation monitor. HRV was recorded before, during and after surfactant administration. Pain assessment was determined by Premature Infant Pain Profile (PIPP) score.
RESULTS


Fourteen infants were enrolled in the study. Demographic characteristics of the groups were similar. PIPP scores did not differ between INSURE and MIST groups (p = 0.05). Statistically significant difference in median HRV during surfactant administration was observed between INSURE and MIST groups (52 vs. 56, p = 0.03). HRV analysis was similar between groups before and after surfactant administration.
CONCLUSION


Surfactant administration with MIST technique might be more comfortable for preterm infants with RDS. However further studies with larger series are needed.",2019,PIPP scores did not differ between INSURE and MIST groups (p = 0.05).,"['Fourteen infants were enrolled in the study', 'preterm infants with RDS', 'preterm infants treated with', 'Preterm infants who required surfactant therapy for RDS']","['INSURE or MIST', 'different surfactant administration techniques', 'Surfactant administration with MIST technique', 'surfactant']","['median HRV', 'Neonatal pain and heart rate variability', 'heart rate variability (HRV', 'HRV', 'pain perception', 'HRV analysis', 'Premature Infant Pain Profile (PIPP) score', 'Pain assessment', 'PIPP scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}]",,0.109183,PIPP scores did not differ between INSURE and MIST groups (p = 0.05).,"[{'ForeName': 'Nilufer', 'Initials': 'N', 'LastName': 'Okur', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. n.matur@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Uras', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Buyuktiryaki', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Mehmet Y', 'Initials': 'MY', 'LastName': 'Oncel', 'Affiliation': 'Katip Celebi University Faculty of Medicine, Neonatal Intensive Unit, Izmir, Turkey.'}, {'ForeName': 'Fatma N', 'Initials': 'FN', 'LastName': 'Saria', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Erbu', 'Initials': 'E', 'LastName': 'Yarci', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Evrim A', 'Initials': 'EA', 'LastName': 'Dizdar', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Fuat E', 'Initials': 'FE', 'LastName': 'Canpolat', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Serife S', 'Initials': 'SS', 'LastName': 'Oguz', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}]",Archivos argentinos de pediatria,['10.5546/aap.2019.eng.397']
3196,30758267,Coping Versus Mastery Modeling Intervention to Enhance Self-efficacy for Exercise in Patients with COPD.,"The literature suggests self-efficacy is a determinant of physical activity and management of Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study was to (1) test the effects of two vicarious experience interventions, coping versus mastery modeling, on self-efficacy in COPD patients performing a cardiopulmonary exercise test (CPET), and (2) determine the type of self-efficacy most strongly related to physical activity in COPD patients. After a baseline assessment of self-efficacy (task, coping for exercise, coping for breathing, scheduling, and walking) and potential moderators, 120 COPD patients watched a mastery model or coping model CPET video, or received usual care verbal instructions. Then, self-efficacy was assessed, followed by a CPET, and another assessment of self-efficacy. Fitbits tracked participants' step count the week following contact. Repeated measures MANOVAs assessed the intervention effects and multiple regressions assessed the contribution of self-efficacy subtypes to step count. All self-efficacy subtypes improved in the mastery and coping conditions, although greater improvement of self-efficacy for coping with exercise barriers was observed in the coping condition. Self-efficacy did not improve in the control condition and no moderators were identified. Self-efficacy for coping with exercise barriers was the self-efficacy subtype most strongly related to step count. This research suggests modeling is a useful intervention technique to enhance self-efficacy in COPD patients, although coping models may be more beneficial than mastery models for enhancing capability beliefs during complex tasks. Future interventions in COPD patients should target self-efficacy for coping with exercise barriers.",2020,"All self-efficacy subtypes improved in the mastery and coping conditions, although greater improvement of self-efficacy for coping with exercise barriers was observed in the coping condition.","['COPD patients performing a', 'Patients with COPD', '120 COPD patients watched a', 'Chronic Obstructive Pulmonary Disease (COPD', 'COPD patients']","['vicarious experience interventions, coping versus mastery modeling', 'cardiopulmonary exercise test (CPET', 'mastery model or coping model CPET video, or received usual care verbal instructions', 'Coping Versus Mastery Modeling Intervention']","['contribution of self-efficacy subtypes to step count', 'self-efficacy (task, coping for exercise, coping for breathing, scheduling, and walking', 'Self-efficacy', 'self-efficacy']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",120.0,0.0142585,"All self-efficacy subtypes improved in the mastery and coping conditions, although greater improvement of self-efficacy for coping with exercise barriers was observed in the coping condition.","[{'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Selzler', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Rodgers', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Berry', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Stickland', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2018.1561411']